4. Company Contact. Notification of Adverse Events ... the setup or data displayed on your patient monitor. Conventions ... 3.4.1 Installing a Battery .
... 2 - 5. Preface. Manual Purpose. The pulse oximeter is to be operated by, or ... Genius™ 3 Tethered Tympanic Thermometer ...
... ..........10 - 11. 10.5.4 Fahrenheit or Celsius Conversion ....................................................................................10 - 11. Page 13 ...
VS 9/VS 9A/VS 9C VS 8/VS 8A/VS 8C
Vital Signs Monitor
Operator's Manual
© Copyright 2020-2021 Shenzhen Mindray Bio-Medical Electronics Co., Ltd. All rights reserved. Release time: 2021-04 Revision: 4.0
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Intellectual Property Statement
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD. (hereinafter called Mindray) owns the intellectual property rights to this Mindray product and this manual. This manual may refer to information protected by copyrights or patents and does not convey any license under the patent rights of Mindray, nor the rights of others. Mindray intends to maintain the contents of this manual as confidential information. Disclosure of the information in this manual in any manner whatsoever without the written permission of Mindray is strictly forbidden. Release, amendment, reproduction, distribution, rental, adaption and translation of this manual in any manner whatsoever without the written permission of Mindray is strictly forbidden.
is the registered trademark owned by Mindray in China and other countries. All other trademarks that appear in this manual are used only for editorial purposes without the intention of improperly using them. They are the property of their respective owners.
Responsibility on the Manufacturer Party
Contents of this manual are subject to changes without prior notice. All information contained in this manual is believed to be correct. Mindray shall not be liable for errors contained herein nor for incidental or consequential damages in connection with the furnishing, performance, or use of this manual. Mindray is responsible for the effects on safety, reliability and performance of this product, only if: all installation operations, expansions, changes, modifications and repairs of this
product are conducted by Mindray authorized personnel; the electrical installation of the relevant room complies with the applicable
national and local requirements; the product is used in accordance with the instructions for use.
WARNING
· This equipment must be operated by skilled/trained clinical professionals. · It is important for the hospital or organization that employs this equipment
to carry out a reasonable service/maintenance plan. Neglect of this may result in machine breakdown or personal injury.
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Warranty
THIS WARRANTY IS EXCLUSIVE AND IS IN LIEU OF ALL OTHER WARRANTIES, EXPRESSED OR IMPLIED, INCLUDING WARRANTIES OF MERCHANTABILITY OR FITNESS FOR ANY PARTICULAR PURPOSE.
Exemptions
Mindray's obligation or liability under this warranty does not include any transportation or other charges or liability for direct, indirect or consequential damages or delay resulting from the improper use or application of the product or the use of parts or accessories not approved by Mindray or repairs by people other than Mindray authorized personnel. This warranty shall not extend to Malfunction or damage caused by improper use or man-made failure. Malfunction or damage caused by unstable or out-of-range power input. Malfunction or damage caused by force majeure such as fire and earthquake. Malfunction or damage caused by improper operation or repair by unqualified or
unauthorized service people. Malfunction of the instrument or part whose serial number is not legible enough. Others not caused by instrument or part itself.
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Company Contact
Manufacturer: Address
Website E-mail Address: Tel: Fax:
Shenzhen Mindray Bio-Medical Electronics Co., Ltd. Mindray Building, Keji 12th Road South, High-tech Industrial Park, Nanshan, Shenzhen 518057, P.R.China www.mindray.com service@mindray.com +86 755 81888998 +86 755 26582680
EC-Representative: Address: Tel: Fax:
Shanghai International Holding Corp. GmbH (Europe) Eiffestrae 80, 20537 Hamburg, Germany 0049-40-2513175 0049-40-255726
Notification of Adverse Events
As a health care provider, you may report the occurrence of certain events to SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD., and possibly to the competent authority of the Member state in which the user and / or patient is established.
These events, include device-related death and serious injury or illness. In addition, as part of our Quality Assurance Program, SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD. requests to be notified of device failures or malfunctions. This information is required to ensure that SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD. provides only the highest quality products.
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Preface
Manual Purpose
The pulse oximeter is to be operated by, or under the supervision of, qualified personnel only. The manual, accessories, directions for use, all precautionary information, and specifications should be read before use. This manual contains the instructions necessary to operate the product safely and in accordance with its function and intended use. Observance of this manual is a prerequisite for proper product performance and correct operation and ensures patient and operator safety. This manual is based on the maximum configuration and therefore some contents may not apply to your product. If you have any question, please contact us. This manual is an integral part of the product. It should always be kept close to the equipment so that it can be obtained conveniently when needed.
Intended Audience
This manual is geared for clinical professionals who are expected to have a working knowledge of medical procedures, practices and terminology as required for monitoring of critically ill patients.
Illustrations
All illustrations in this manual serve as examples only. They may not necessarily reflect the setup or data displayed on your patient monitor.
Conventions
Italic text is used in this manual to quote the referenced manuals, chapters, sections and formulas.
Bold text is used to indicate the screen texts and names of hard keys. is used to indicate operational procedures.
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Contents
1 Safety ..........................................................................................................................................1 - 1
1.1 Safety Information .......................................................................................................................................1 - 1 1.1.1 Warnings ..........................................................................................................................................1 - 1 1.1.2 Cautions ............................................................................................................................................1 - 2 1.1.3 Notes ..................................................................................................................................................1 - 3
1.2 Equipment Symbols ....................................................................................................................................1 - 4
2 Equipment Introduction ............................................................................................................2 - 1
2.1 Intended Use ..................................................................................................................................................2 - 1 2.2 Intended Users ..............................................................................................................................................2 - 1 2.3 Intended patient population ....................................................................................................................2 - 1 2.4 Intended Medical conditions ...................................................................................................................2 - 1 2.5 Contra-indications ........................................................................................................................................2 - 2 2.6 Applied Parts ..................................................................................................................................................2 - 2 2.7 Main Unit .........................................................................................................................................................2 - 2
2.7.1 Front View (VS 9 Series) ..............................................................................................................2 - 2 2.7.2 Front View (VS 8 Series) ..............................................................................................................2 - 3 2.7.3 Side View (VS 9 Series) .................................................................................................................2 - 5 2.7.4 Side View (VS 8 Series) .................................................................................................................2 - 6 2.7.5 Rear View (VS 9 Series) ................................................................................................................2 - 7 2.7.6 Rear View (VS 8 Series) ................................................................................................................2 - 8
3 Getting Started ...........................................................................................................................3 - 1
3.1 Equipment Preparation Safety Information .......................................................................................3 - 1 3.2 Unpacking and Checking ..........................................................................................................................3 - 2 3.3 Environmental Requirements ..................................................................................................................3 - 2 3.4 Setting Up the Equipment ........................................................................................................................3 - 3
3.4.1 Installing a Battery ........................................................................................................................3 - 3 3.4.2 Connecting the AC Mains ..........................................................................................................3 - 4 3.4.3 Connecting a Barcode Reader ..................................................................................................3 - 5 3.4.4 Connecting a Digital Scale .........................................................................................................3 - 5 3.5 Turning on the Monitor ..............................................................................................................................3 - 5 3.6 Start Wizard ....................................................................................................................................................3 - 5 3.7 Operation and Navigation .........................................................................................................................3 - 6 3.7.1 Using the Touchscreen ...............................................................................................................3 - 6 3.7.2 Using the Knob (For VS 8 Series) ..............................................................................................3 - 7 3.7.3 Using the On-Screen Keyboard ................................................................................................3 - 7 3.7.4 Using the Barcode Reader .........................................................................................................3 - 7 3.8 Screen Display ...............................................................................................................................................3 - 8 3.8.1 Main Screen .....................................................................................................................................3 - 8 3.8.2 Menus ................................................................................................................................................3 - 9
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3.8.3 Quick Keys ..................................................................................................................................... 3 - 10 3.8.4 On-screen Symbols .................................................................................................................... 3 - 10 3.9 Configuring Your Monitor ...................................................................................................................... 3 - 11 3.9.1 Setting Device Location ........................................................................................................... 3 - 11 3.9.2 Setting the Workflow ................................................................................................................ 3 - 12 3.9.3 Adjusting Screen Brightness .................................................................................................. 3 - 18 3.9.4 Adjusting the Volume .............................................................................................................. 3 - 18 3.9.5 Changing Measurement Colors ............................................................................................ 3 - 18 3.9.6 Setting System Language ....................................................................................................... 3 - 18 3.9.7 Setting the Date and Time ...................................................................................................... 3 - 19 3.9.8 Setting Parameter Units .......................................................................................................... 3 - 19 3.9.9 Checking Software Licenses ................................................................................................... 3 - 20 3.10 Start Working ............................................................................................................................................ 3 - 20 3.10.1 Selecting a Work Mode .......................................................................................................... 3 - 20 3.10.2 Inputting Patient Information ............................................................................................. 3 - 22 3.10.3 Accessing Parameter Setup Menus ................................................................................... 3 - 22 3.10.4 Checking the Alarm Settings ............................................................................................... 3 - 22 3.11 Stopping a Parameter Measurement ............................................................................................... 3 - 23 3.12 Turning Off the Monitor ....................................................................................................................... 3 - 23
4 Managing Patients .....................................................................................................................4 - 1
4.1 Admitting a Patient ......................................................................................................................................4 - 1 4.1.1 Automatically Admitting a Patient .........................................................................................4 - 1 4.1.2 Manually Admitting a Patient ...................................................................................................4 - 1
4.2 Managing Patient Information ................................................................................................................4 - 2 4.2.1 Entering the Patient Management Menu ............................................................................4 - 2 4.2.2 Editing Patient Information .......................................................................................................4 - 2
4.3 Discharging a Patient ..................................................................................................................................4 - 2 4.3.1 Manually Discharging a Patient ...............................................................................................4 - 3 4.3.2 Auto Discharging a Patient after Monitor Power Off .......................................................4 - 3 4.3.3 Changing Patient Management Settings .............................................................................4 - 3 4.3.4 Setting Monitor Information .....................................................................................................4 - 4 4.3.5 Setting Patient Location .............................................................................................................4 - 4
4.4 Deleting Patient Data ..................................................................................................................................4 - 4
5 Managing Configurations ..........................................................................................................5 - 1
5.1 Configuration Introduction .......................................................................................................................5 - 1 5.2 Changing the Department ........................................................................................................................5 - 1 5.3 Setting Default Patient Category ............................................................................................................5 - 2 5.4 Setting Workflows ........................................................................................................................................5 - 2 5.5 Transferring a Configuration ....................................................................................................................5 - 2
5.5.1 Exporting a Configuration .........................................................................................................5 - 2 5.5.2 Importing a Configuration .........................................................................................................5 - 2 5.6 Modifying Configuration Password .......................................................................................................5 - 3 5.7 Restoring the Latest Configuration Automatically ...........................................................................5 - 3
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6 Networked Monitoring ..............................................................................................................6 - 1
6.1 Network Introduction .................................................................................................................................6 - 1 6.2 Network Safety Information .....................................................................................................................6 - 1 6.3 Connecting the Monitor to the CMS .....................................................................................................6 - 2 6.4 Connecting the eGateway .........................................................................................................................6 - 2 6.5 MLDAP ..............................................................................................................................................................6 - 2 6.6 Connecting the Wireless Network ..........................................................................................................6 - 3
7 Alarms .........................................................................................................................................7 - 1
7.1 Alarm Introduction ......................................................................................................................................7 - 1 7.2 Alarm Safety Information ..........................................................................................................................7 - 1 7.3 Understanding the Alarms ........................................................................................................................7 - 2
7.3.1 Alarm Categories ...........................................................................................................................7 - 2 7.3.2 Alarm Priorities ...............................................................................................................................7 - 2 7.3.3 Alarm Indicators ............................................................................................................................7 - 2 7.3.4 Alarm Status Symbols ..................................................................................................................7 - 4 7.4 Checking Alarm List .....................................................................................................................................7 - 4 7.5 Accessing On-screen Help for Technical Alarms (AlarmSight) .....................................................7 - 4 7.6 Changing Alarm Settings ...........................................................................................................................7 - 4 7.6.1 Setting Parameter Alarm Properties (Continuous Monitoring Mode) .......................7 - 4 7.6.2 Setting Alarm Tone Properties .................................................................................................7 - 5 7.6.3 Setting the Alarm Delay Time ...................................................................................................7 - 6 7.6.4 Setting the Apnea Delay Time ..................................................................................................7 - 6 7.6.5 Restoring the Default Alarm Settings ....................................................................................7 - 6 7.6.6 Setting the CMS and eGateway Disconnection Alarm ....................................................7 - 7 7.6.7 Setting the Switch of the SpO2 Desat Alarm Off ................................................................7 - 7 7.6.8 Setting the Switch of the Apnea Alarm Off .........................................................................7 - 7 7.7 Pausing Alarms/Pausing Alarm Tones ..................................................................................................7 - 7 7.7.1 Defining the Pause Function ....................................................................................................7 - 7 7.7.2 Pausing Alarms ..............................................................................................................................7 - 8 7.7.3 Pausing Alarm Sound ..................................................................................................................7 - 9 7.8 Resetting Alarms ........................................................................................................................................ 7 - 10 7.8.1 Resetting Physiological Alarms ............................................................................................. 7 - 10 7.8.2 Resetting Technical Alarms .................................................................................................... 7 - 11 7.8.3 Setting Alarm Light Status on Alarm Reset ...................................................................... 7 - 11 7.9 Latching Alarms ......................................................................................................................................... 7 - 11 7.10 Nurse Call ................................................................................................................................................... 7 - 12 7.11 Testing Alarms .......................................................................................................................................... 7 - 12 7.12 Actions When an Alarm Occurs ......................................................................................................... 7 - 12
8 Monitoring Pulse Oxygen Saturation (SpO2) ...........................................................................8 - 1
8.1 SpO2 Introduction ........................................................................................................................................8 - 1 8.2 SpO2 Safety Information ............................................................................................................................8 - 2 8.3 SpO2 Measurement Limitations ..............................................................................................................8 - 3
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8.4 SpO2 Display ...................................................................................................................................................8 - 5 8.5 Preparing for SpO2 Monitoring ...............................................................................................................8 - 5 8.6 Changing the SpO2 Settings ....................................................................................................................8 - 6
8.6.1 Changing the SpO2 Alarm Settings ........................................................................................8 - 6 8.6.2 Nellcor Sat-SecondsTM Alarm Management .......................................................................8 - 7 8.6.3 Setting the Nellcor SpO2 Sat-Seconds ...................................................................................8 - 8 8.6.4 Setting SpO2 Sensitivity (for Masimo SpO2) ........................................................................8 - 9 8.6.5 Enabling FastSAT (for Masimo SpO2) .....................................................................................8 - 9 8.6.6 Displaying SIQ (for Masimo SpO2) ....................................................................................... 8 - 10 8.6.7 Changing Averaging Time (for Masimo SpO2) ................................................................ 8 - 10 8.6.8 Changing the Sensitivity (for Mindray SpO2) ................................................................... 8 - 11 8.6.9 Showing/Hiding PI ..................................................................................................................... 8 - 11 8.6.10 Monitoring SpO2 and NIBP Simultaneously .................................................................. 8 - 11 8.6.11 Changing the Sweep Speed of the Pleth Wave ............................................................ 8 - 12 8.6.12 Setting the Alarm Priority for SpO2 Sensor Off Alarm ................................................ 8 - 12 8.6.13 Setting the SpO2 Tone Mode .............................................................................................. 8 - 12 8.7 SpO2 Troubleshooting ............................................................................................................................. 8 - 12 8.8 Nellcor Information .................................................................................................................................. 8 - 13 8.9 Masimo Information ................................................................................................................................. 8 - 14
9 Monitoring PR .............................................................................................................................9 - 1
9.1 PR Introduction .............................................................................................................................................9 - 1 9.2 PR Display ........................................................................................................................................................9 - 1 9.3 Changing the PR Settings ..........................................................................................................................9 - 1
9.3.1 Changing the PR Alarm Settings .............................................................................................9 - 1 9.3.2 Changing the Pulse Volume ......................................................................................................9 - 2 9.3.3 Enabling Irregular PR ...................................................................................................................9 - 2
10 Measuring Temperature (Temp) ............................................................................................10 - 1
10.1 Temp Introduction ................................................................................................................................. 10 - 1 10.2 Temp Display ............................................................................................................................................ 10 - 1 10.3 Monitoring Temp with SmarTempTM Module ................................................................................ 10 - 2
10.3.1 Measuring Temp ...................................................................................................................... 10 - 3 10.3.2 Disinfecting Temperature Probe ....................................................................................... 10 - 5 10.4 Monitoring Temp with GeniusTM 3 Tethered Tympanic Thermometer ................................ 10 - 6 10.4.1 Safety Information ................................................................................................................... 10 - 6 10.4.2 Thermometer Buttons ........................................................................................................... 10 - 6 10.4.3 Equivalence Mode Temperature ........................................................................................ 10 - 7 10.4.4 Taking a Temperature ............................................................................................................ 10 - 7 10.4.5 Troubleshooting ...................................................................................................................... 10 - 8 10.4.6 Cleaning and Disinfecting the Tympanic Thermometer ........................................... 10 - 8 10.5 Monitoring Temp with Exergen TemporalScannerTM Thermometer ................................... 10 - 8 10.5.1 Safety Information ................................................................................................................... 10 - 9 10.5.2 Taking a Temperature with the TemporalScannerTM ................................................... 10 - 9 10.5.3 Understanding the TemporalScannerTM Thermometer LED Display ...................10 - 11 10.5.4 Fahrenheit or Celsius Conversion ....................................................................................10 - 11
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10.5.5 Replacing the Battery ...........................................................................................................10 - 12 10.5.6 Troubleshooting ....................................................................................................................10 - 12 10.5.7 Cleaning the TemporalScannerTM Thermometer ........................................................10 - 13 10.6 Monitoring Temp with HeTaida Thermometer ..........................................................................10 - 13 10.6.1 Overview of HeTaida Thermometer ...............................................................................10 - 13 10.6.2 Taking a Temperature with HeTaida Thermometer .................................................10 - 14 10.7 Manually Inputting Temp ..................................................................................................................10 - 14
11 Measuring Noninvasive Blood Pressure (NIBP) ...................................................................11 - 1
11.1 NIBP Introduction .................................................................................................................................... 11 - 1 11.2 NIBP Safety Information ....................................................................................................................... 11 - 2 11.3 NIBP Measurement Limitations ......................................................................................................... 11 - 3 11.4 Measurement Modes ............................................................................................................................. 11 - 3 11.5 NIBP Display .............................................................................................................................................. 11 - 3 11.6 Preparing for NIBP Measurement ..................................................................................................... 11 - 5
11.6.1 Preparing the Patient for NIBP Measurement ............................................................... 11 - 5 11.6.2 Placing the NIBP Cuff .............................................................................................................. 11 - 6 11.7 Performing Measurement .................................................................................................................... 11 - 7 11.7.1 Performing Manual Measurement .................................................................................... 11 - 7 11.7.2 Performing Auto Measurement ......................................................................................... 11 - 7 11.7.3 Performing STAT Measurement ......................................................................................... 11 - 8 11.7.4 Performing Sequence Measurement ............................................................................... 11 - 8 11.8 Changing NIBP Settings ........................................................................................................................ 11 - 9 11.8.1 Setting the NIBP Alarm Properties .................................................................................... 11 - 9 11.8.2 Setting the NIBP Interval ....................................................................................................... 11 - 9 11.8.3 Enabling the NIBP End Tone ................................................................................................ 11 - 9 11.8.4 Setting NIBP Sequence .......................................................................................................... 11 - 9 11.8.5 Setting the NIBP Display Format ......................................................................................11 - 10 11.8.6 Setting the NIBP Alarm Limits Display Switch .............................................................11 - 10 11.8.7 Selecting NIBP Measurement Algorithm ......................................................................11 - 10 11.8.8 Setting Measurement Times .............................................................................................11 - 11 11.8.9 Correcting the NIBP Measurements ...............................................................................11 - 11 11.9 BP Averaging ..........................................................................................................................................11 - 11 11.9.1 Enabling BP Averaging ........................................................................................................11 - 11 11.9.2 BP Averaging Display ...........................................................................................................11 - 12 11.9.3 Performing BP Averaging ...................................................................................................11 - 12 11.9.4 Changing BP Averaging Settings .....................................................................................11 - 13 11.10 Orthostatic BP Measurement .........................................................................................................11 - 14 11.10.1 Enabling Orthostatic BP Measurement .......................................................................11 - 14 11.10.2 Orthostatic BP Measurement Display ..........................................................................11 - 14 11.10.3 Performing Orthostatic BP Measurement ..................................................................11 - 15 11.10.4 Changing Orthostatic BP Measurement Settings ...................................................11 - 15 11.11 Assisting Venous Puncture ..............................................................................................................11 - 17 11.12 NIBP Maintenance ..............................................................................................................................11 - 17 11.12.1 NIBP Leakage Test ...............................................................................................................11 - 17
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11.12.2 NIBP Accuracy Test .............................................................................................................11 - 18 11.13 NIBP Troubleshooting .......................................................................................................................11 - 18
12 Monitoring CO2 .......................................................................................................................12 - 1
12.1 Overview .................................................................................................................................................... 12 - 1 12.2 Safety ........................................................................................................................................................... 12 - 1 12.3 Measurement Limitations .................................................................................................................... 12 - 2 12.4 CO2 Display ............................................................................................................................................... 12 - 2 12.5 Measuring CO2 ......................................................................................................................................... 12 - 3 12.6 Automatic CO2 Module Zeroing ........................................................................................................ 12 - 4 12.7 Changing CO2 Settings ......................................................................................................................... 12 - 4
12.7.1 Changing CO2 Alarm Settings ............................................................................................. 12 - 4 12.7.2 Setting the CO2 Waveform ................................................................................................... 12 - 5 12.7.3 Entering the Standby Mode ................................................................................................. 12 - 5 12.7.4 Setting the Auto Standby ..................................................................................................... 12 - 5 12.7.5 Setting Humidity Compensation ....................................................................................... 12 - 5 12.7.6 Setting Gas Compensation .................................................................................................. 12 - 6 12.7.7 Automatic Barometric Pressure .......................................................................................... 12 - 6 12.7.8 Calibrating the CO2 Module ................................................................................................ 12 - 6
13 Monitoring Respiration .........................................................................................................13 - 1
13.1 Resp Safety Information ....................................................................................................................... 13 - 1 13.2 RR Display .................................................................................................................................................. 13 - 1 13.3 Measurement Limitations of SpO2-Sourced RR ........................................................................... 13 - 2 13.4 Manually Inputting RR Value .............................................................................................................. 13 - 2 13.5 Changing the RR Settings .................................................................................................................... 13 - 2
13.5.1 Enabling SpO2 Source for RR Measurement .................................................................. 13 - 2 13.5.2 Enabling RR Alarms ................................................................................................................. 13 - 2 13.5.3 Setting RR Alarms .................................................................................................................... 13 - 3 13.5.4 Setting the Apnea Alarm Delay .......................................................................................... 13 - 3 13.5.5 Setting Timer Interval ............................................................................................................. 13 - 3
14 Manual Parameters ................................................................................................................14 - 1
14.1 Manual Input Parameters ..................................................................................................................... 14 - 1 14.2 The Manual Input Display .................................................................................................................... 14 - 1 14.3 Inputting/Editing Parameter Information ...................................................................................... 14 - 2 14.4 Changing Manual Input Settings ...................................................................................................... 14 - 3
14.4.1 Changing the Display of Manual Parameters ................................................................ 14 - 3 14.4.2 Adding a New Parameter ...................................................................................................... 14 - 3
15 Clinical Assistive Applications (CAA) ....................................................................................15 - 1
15.1 Early Warning Score (EWS) ................................................................................................................... 15 - 1 15.1.1 The EWS Display ....................................................................................................................... 15 - 2 15.1.2 Accessing the EWS Screen .................................................................................................... 15 - 3 15.1.3 EWS Scoring in Spot Check Mode ..................................................................................... 15 - 4
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15.1.4 EWS Scoring in Continuous Monitoring Mode ............................................................. 15 - 4 15.1.5 EWS Alarm .................................................................................................................................. 15 - 5 15.1.6 Changing EWS Settings ......................................................................................................... 15 - 6 15.1.7 Viewing History Scores .......................................................................................................... 15 - 7 15.2 Glasgow Coma Scale (GCS) .................................................................................................................. 15 - 8 15.2.1 GCS Display ................................................................................................................................ 15 - 9 15.2.2 Accessing the GCS Menu ....................................................................................................15 - 10 15.2.3 Performing GCS Scoring .....................................................................................................15 - 10 15.2.4 Setting Threshold for Each Consciousness Level .......................................................15 - 11 15.2.5 Reviewing GCS Data .............................................................................................................15 - 11 15.3 Pain Score ................................................................................................................................................15 - 11 15.3.1 The Pain Score Display .........................................................................................................15 - 12 15.3.2 Performing Pain Score .........................................................................................................15 - 12 15.3.3 Adding a Custom Pain Scale ..............................................................................................15 - 12 15.3.4 Adding a Pain Description ..................................................................................................15 - 13 15.4 Targeted Goal .........................................................................................................................................15 - 13 15.4.1 Entering the Targeted Goal Screen .................................................................................15 - 13 15.4.2 The Display of the Targeted Goal Screen ......................................................................15 - 14 15.4.3 Operating the Targeted Goal Screen .............................................................................15 - 14
16 Recording ................................................................................................................................16 - 1
16.1 Recorder ..................................................................................................................................................... 16 - 1 16.2 Starting Recordings ................................................................................................................................ 16 - 1 16.3 Stopping Recordings ............................................................................................................................. 16 - 2
16.3.1 Stopping Recordings Manually .......................................................................................... 16 - 2 16.3.2 Stopping Recordings Automatically ................................................................................. 16 - 2 16.4 Recording Related Flags ....................................................................................................................... 16 - 2 16.5 Setting the Recorder .............................................................................................................................. 16 - 2 16.6 Loading Paper .......................................................................................................................................... 16 - 3 16.7 Removing Paper Jam ............................................................................................................................. 16 - 3
17 Review .....................................................................................................................................17 - 1
17.1 Review Overview ..................................................................................................................................... 17 - 1 17.2 Review Page .............................................................................................................................................. 17 - 1
17.2.1 Accessing the Review Page .................................................................................................. 17 - 1 17.2.2 Example Review Page ............................................................................................................ 17 - 1 17.2.3 Reviewing the Tabular Trends ............................................................................................ 17 - 2 17.2.4 Reviewing Scores ..................................................................................................................... 17 - 2 17.2.5 Reviewing the Graphics Trends .......................................................................................... 17 - 3 17.2.6 Reviewing Events ..................................................................................................................... 17 - 3
18 User Maintenance Settings ...................................................................................................18 - 1
18.1 Accessing the Maintenance Menu .................................................................................................... 18 - 1 18.2 The Device Location Settings ............................................................................................................. 18 - 1 18.3 The Patient Management Settings ................................................................................................... 18 - 2
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18.3.1 The Patient Field Tab .............................................................................................................. 18 - 2 18.3.2 The ADT Query Tab ................................................................................................................. 18 - 3 18.3.3 The Discharge Tab ................................................................................................................... 18 - 3 18.3.4 The Location Tab ..................................................................................................................... 18 - 3 18.4 The Authorization Setup Tab .............................................................................................................. 18 - 3 18.4.1 The Clinician Login Tab ......................................................................................................... 18 - 3 18.4.2 The Authorization Setup Tab .............................................................................................. 18 - 4 18.5 The Save&Send Tab ................................................................................................................................ 18 - 5 18.6 The Alarm Tab .......................................................................................................................................... 18 - 6 18.6.1 The Audio Tab ........................................................................................................................... 18 - 6 18.6.2 The Pause/Reset Tab .............................................................................................................. 18 - 7 18.6.3 The Latching Tab ..................................................................................................................... 18 - 9 18.6.4 The Nurse Call Tab ................................................................................................................... 18 - 9 18.6.5 The Other Tab .........................................................................................................................18 - 10 18.7 The Standby Settings ...........................................................................................................................18 - 11 18.8 The CAA Settings ...................................................................................................................................18 - 11 18.8.1 The EWS Tab ............................................................................................................................18 - 11 18.8.2 The GCS Tab .............................................................................................................................18 - 12 18.9 The Module Settings ............................................................................................................................18 - 12 18.9.1 The NIBP Tab ...........................................................................................................................18 - 12 18.9.2 The CO2 Tab ............................................................................................................................18 - 13 18.9.3 The Temp Tab .........................................................................................................................18 - 14 18.9.4 The Manual Input Tab ..........................................................................................................18 - 14 18.9.5 The Pain Score Tab ................................................................................................................18 - 14 18.9.6 The Other Tab .........................................................................................................................18 - 14 18.10 The Unit Settings ................................................................................................................................18 - 15 18.11 The Time Settings ...............................................................................................................................18 - 15 18.11.1 The Time Synchronization Tab .......................................................................................18 - 15 18.11.2 The Daylight Savings Time Tab ......................................................................................18 - 16 18.12 The Version Tab ...................................................................................................................................18 - 16 18.13 The Battery Information Settings ..................................................................................................18 - 16 18.14 The Scanner Settings .........................................................................................................................18 - 16 18.14.1 The Scanner Info. Tab ........................................................................................................18 - 16 18.14.2 The JADAK Barcode Tab ...................................................................................................18 - 17 18.14.3 The Identify Scanner Tab (for the non-Mindray Custom 2D Barcode Reader) ...18 17 18.14.4 The Field Tab (for the Mindray Custom 2D Barcode Reader) ..............................18 - 18 18.15 The Record Settings ...........................................................................................................................18 - 18 18.16 The Network Setup Settings ...........................................................................................................18 - 18 18.16.1 The Network Type Tab ......................................................................................................18 - 18 18.16.2 The LAN1 IP Tab ...................................................................................................................18 - 18 18.16.3 The WLAN Tab ......................................................................................................................18 - 19 18.16.4 The WLAN IP Tab .................................................................................................................18 - 19 18.16.5 The Transfer Setup Tab .....................................................................................................18 - 20 18.16.6 The Device Discover Tab ..................................................................................................18 - 21 18.16.7 The QoS Tab ..........................................................................................................................18 - 22
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18.16.8 The MLDAP Tab ...................................................................................................................18 - 22 18.16.9 The VitalsLink Tab ...............................................................................................................18 - 22 18.17 The Bluetooth Tab ..............................................................................................................................18 - 23 18.18 The Other Tab ......................................................................................................................................18 - 24
19 Battery .....................................................................................................................................19 - 1
19.1 Overview .................................................................................................................................................... 19 - 1 19.2 Battery Safety Information ................................................................................................................... 19 - 1 19.3 Battery Indications .................................................................................................................................. 19 - 2
19.3.1 Battery LED ................................................................................................................................. 19 - 2 19.3.2 Battery Symbols ....................................................................................................................... 19 - 2 19.3.3 Battery-related Alarms ........................................................................................................... 19 - 3 19.4 Replacing the Battery (for VS 9 Series) ............................................................................................ 19 - 3 19.5 Replacing the Battery (For VS 8 Series) ........................................................................................... 19 - 4 19.6 Connecting an External Battery ......................................................................................................... 19 - 5 19.7 Charging a Battery .................................................................................................................................. 19 - 5 19.8 Maintaining the Battery ........................................................................................................................ 19 - 5 19.8.1 Conditioning the Battery ...................................................................................................... 19 - 5 19.8.2 Checking Battery Performance ........................................................................................... 19 - 6 19.9 Storing Batteries ...................................................................................................................................... 19 - 6 19.10 Recycling Batteries ............................................................................................................................... 19 - 7
20 Care and Cleaning ..................................................................................................................20 - 1 20.1 Care and Cleaning Introduction ........................................................................................................ 20 - 1 20.2 Care and Cleaning Safety Information ............................................................................................ 20 - 1 20.3 Cleaning and Disinfecting the Main Unit ....................................................................................... 20 - 2 20.3.1 Cleaning the Main Unit .......................................................................................................... 20 - 2 20.3.2 Disinfecting the Main Unit ................................................................................................... 20 - 2 20.3.3 Approved Cleaning and Disinfecting Agents for Main Unit .................................... 20 - 2 20.4 Cleaning and Disinfecting the Accessories .................................................................................... 20 - 5 20.4.1 Cleaning and Disinfecting Agents for the NIBP Air Hose .......................................... 20 - 6 20.4.2 Cleaning and Disinfecting Agents for the SpO2 Cable .............................................. 20 - 7 20.4.3 Cleaning the Accessories ...................................................................................................... 20 - 8 20.4.4 Disinfecting the Accessories ................................................................................................ 20 - 8 20.5 Sterilization ............................................................................................................................................... 20 - 8 20.6 Impact of Improper Cleaning ............................................................................................................. 20 - 8
21 Maintenance ...........................................................................................................................21 - 1
21.1 Maintenance Introduction ................................................................................................................... 21 - 1 21.2 Maintenance Safety Information ....................................................................................................... 21 - 1 21.3 Maintenance and Testing Schedule ................................................................................................. 21 - 2 21.4 Checking Version Information ........................................................................................................... 21 - 3 21.5 Testing Methods and Procedures ..................................................................................................... 21 - 3
21.5.1 Performing Visual Inspection .............................................................................................. 21 - 4
9
21.5.2 Performing Power-on Test ................................................................................................... 21 - 4 21.5.3 Testing the Recorder .............................................................................................................. 21 - 4 21.5.4 Checking the Battery .............................................................................................................. 21 - 4 21.6 Disposing of the Monitor ..................................................................................................................... 21 - 4
22 Accessories ..............................................................................................................................22 - 1
22.1 SpO2 Accessories ..................................................................................................................................... 22 - 1 22.1.1 SpO2 Extension Cable ............................................................................................................ 22 - 2 22.1.2 Mindray SpO2 Sensors ........................................................................................................... 22 - 2 22.1.3 Masimo SpO2 Sensors ........................................................................................................... 22 - 3 22.1.4 Nellcor SpO2 Sensors ............................................................................................................. 22 - 3
22.2 NIBP Accessories ...................................................................................................................................... 22 - 4 22.2.1 NIBP Hoses ................................................................................................................................. 22 - 4 22.2.2 Reusable NIBP Cuffs ................................................................................................................ 22 - 4 22.2.3 Disposable NIBP Cuffs ............................................................................................................ 22 - 5
22.3 Temp Accessories ................................................................................................................................... 22 - 5 22.3.1 SmarTempTM Accessories ....................................................................................................... 22 - 5 22.3.2 GeniusTM 3 Tympanic Thermometer Accessories .......................................................... 22 - 6 22.3.3 Exergen TemporalScannerTM Thermometer Accessories ........................................... 22 - 6 22.3.4 HeTaida Thermometer ........................................................................................................... 22 - 7
22.4 CO2 Accessories ....................................................................................................................................... 22 - 7 22.5 Others .......................................................................................................................................................... 22 - 9
A Product Specifications .............................................................................................................. A - 1
A.1 Classifications ............................................................................................................................................... A - 1 A.2 Environmental Specifications ................................................................................................................. A - 1
A.2.1 Main Unit ........................................................................................................................................ A - 1 A.2.2 SmarTempTM Temperature Module ....................................................................................... A - 2 A.2.3 GeniusTM 3 Temperature Module ............................................................................................ A - 2 A.2.4 Exergen TemporalScanner Thermometer .......................................................................... A - 2 A.2.5 HeTaiDa Infrared Thermometer ............................................................................................. A - 2 A.3 Power Supply Specifications ................................................................................................................... A - 3 A.3.1 AC Power Supply Specifications ............................................................................................ A - 3 A.3.2 Battery Specifications of VS 9 Series ..................................................................................... A - 3 A.3.3 Battery Supply Specifications of VS 8 Series ...................................................................... A - 4 A.4 Physical Specifications .............................................................................................................................. A - 4 A.5 Hardware Specifications ........................................................................................................................... A - 4 A.5.1 Display Specifications of VS 9 Series ..................................................................................... A - 4 A.5.2 Display Specifications of VS 8 Series ..................................................................................... A - 4 A.5.3 Recorder Specifications ............................................................................................................. A - 5 A.5.4 LEDs .................................................................................................................................................. A - 5 A.5.5 Audio Indicator ............................................................................................................................. A - 5 A.5.6 Monitor Interface Specifications ............................................................................................ A - 5 A.5.7 Outputs Specifications .............................................................................................................. A - 5 A.5.8 Wi-Fi Technical Specifications ................................................................................................. A - 6 A.5.9 Wi-Fi Performance Specifications .......................................................................................... A - 6
10
A.5.10 Blue Tooth Specification ......................................................................................................... A - 7 A.5.11 Bluetooth Performance Specifications .............................................................................. A - 7 A.6 Measurement Specifications ................................................................................................................... A - 8 A.6.1 SpO2 Specifications ..................................................................................................................... A - 8 A.6.2 PR .....................................................................................................................................................A - 11 A.6.3 NIBP ................................................................................................................................................A - 12 A.6.4 Temp Specifications .................................................................................................................A - 14 A.6.5 CO2 Specifications .....................................................................................................................A - 16 A.6.6 RR Specifications ........................................................................................................................A - 17 A.7 Operating Environment ..........................................................................................................................A - 18
B EMC and Radio Regulatory Compliance ...................................................................................B - 1
B.1 EMC ....................................................................................................................................................................B - 1 B.2 Radio Regulatory Compliance .................................................................................................................B - 7
C Default Settings .........................................................................................................................C - 1
C.1 Parameters Default Settings ................................................................................................................... C - 1 C.1.1 SpO2 Default Settings ................................................................................................................ C - 1 C.1.2 PR ....................................................................................................................................................... C - 2 C.1.3 Temp Default Settings (SmarTemp) ..................................................................................... C - 2 C.1.4 NIBP Default Settings ................................................................................................................. C - 2 C.1.5 CO2 Default Settings ................................................................................................................... C - 5 C.1.6 EWS Default Settings .................................................................................................................. C - 6
C.2 Routine Default Settings .......................................................................................................................... C - 7 C.2.1 Alarm Default Settings ............................................................................................................... C - 7 C.2.2 Parameter Color Default Settings .......................................................................................... C - 7 C.2.3 Display Default Settings ............................................................................................................ C - 8 C.2.4 Volume Default Settings ........................................................................................................... C - 8 C.2.5 Record Setup ................................................................................................................................. C - 8 C.2.6 System Time Default Settings ................................................................................................. C - 9
D Alarm Messages ........................................................................................................................ D - 1
D.1 Physiological Alarm Messages ............................................................................................................... D - 1 D.1.1 General Physiological Alarm Messages ............................................................................... D - 1 D.1.2 SpO2 Physiological Alarm Messages .................................................................................... D - 1 D.1.3 PR Physiological Alarm Messages ......................................................................................... D - 1 D.1.4 NIBP Physiological Alarm Messages ..................................................................................... D - 2 D.1.5 EWS Physiological Alarm Messages ...................................................................................... D - 2
D.2 Technical Alarm Messages ...................................................................................................................... D - 2 D.2.1 General Technical Alarm Messages ...................................................................................... D - 3 D.2.2 SpO2 Technical Alarm Messages ............................................................................................ D - 3 D.2.3 Temp Technical Alarm Messages .......................................................................................... D - 5 D.2.4 NIBP Technical Alarm Messages ............................................................................................ D - 6 D.2.5 CO2 Technical Alarm Messages .............................................................................................. D - 8 D.2.6 EWS Technical Alarms ................................................................................................................ D - 8 D.2.7 Power Supply Technical Alarm Messages .......................................................................... D - 9 D.2.8 Technical Alarm Messages Related to Networked Monitoring ................................D - 10
11
D.2.9 Other System Technical Alarm Messages .........................................................................D - 10 E Abbreviations ............................................................................................................................. E - 1 F Declaration of Conformity ......................................................................................................... F - 1
12
1 Safety
1.1 Safety Information
WARNING
· Indicates a potential hazard or unsafe practice that, if not avoided, could
result in death or serious injury.
CAUTION
· Indicates a potential hazard or unsafe practice that, if not avoided, could
result in minor personal injury or product/property damage.
NOTE
· Provides application tips or other useful information to ensure that you get
the most from your product.
1.1.1 Warnings
WARNING
· This equipment is used for single patient at a time. · To avoid explosion hazard, do not use the equipment in the presence of
oxygen-rich atmospheres, flammable anesthetics, or other flammable agents.
· The equipment is not intended to be used within the Magnetic Resonance
(MR) environment.
· Before connecting the equipment to the power line, check that the voltage
and frequency ratings of the power line are the same as those indicated on the equipment's label or in this manual.
· Before putting the system into operation, the operator must verify that the
equipment, connecting cables and accessories are in correct working order and operating condition.
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· To avoid risk of electric shock, the equipment must only be connected to
mains power with protective earth. If a protective earth conductor is not
provided, operate it on battery power, if possible.
· Do not use the multiple portable socket outlets (MPSO) or AC mains
extension cords. Insure that the sum of the individual ground leakage
currents does not exceed the allowable limits.
· Do not touch the patient and live parts simultaneously. Otherwise patient
injury may result.
· Do not come into contact with the patient during defibrillation. Otherwise
serious injury or death could result.
· Do not open the equipment housings. All servicing and future upgrades must
be carried out by trained and authorized personnel.
· Do not rely exclusively on the audible alarm system for patient monitoring.
Turning the alarm volume to a low level or off may result in a hazard to the
patient. Remember that alarm settings should be customized according to
patient situations. Always keep the patient under close surveillance.
· Physiological data and alarm messages provided by the monitor should not
be used as the sole basis for diagnosis or therapy decisions. They must be
used in conjunction with clinical signs and symptoms. Misinterpretation of
the measured values or other parameters can endanger the patient.
· Do not place the equipment or accessories in any position that might cause it
to fall on the patient.
· Do not start or operate the equipment unless the setup was verified to be
correct.
· To avoid inadvertent disconnection, route all cables in a way to prevent a
stumbling hazard. Wrap and secure excess cabling to reduce risk of
entanglement by patients or personnel.
· The equipment should not be used as the sole basis for medical decisions. It
must be used in conjunction with clinical signs and symptom. If any
measurement seems questionable, first check the patient's vital signs by
alternate means and then check the equipment for proper functioning.
· The software equipment copyright is solely owned by Mindray. No
organization or individual shall resort to modifying, copying, or exchanging
it or to any other infringement on it in any form or by any means without due
permission.
1.1.2
Cautions
CAUTION
· Use only parts and accessories specified in this manual.
1 - 2
· Ensure that the equipment is supplied with continuous electric power during
work. Sudden power failure may cause data loss.
· Magnetic and electrical fields are capable of interfering with the proper
performance of the equipment. For this reason make sure that all external
devices operated in the vicinity of the equipment comply with the relevant
EMC requirements. Mobile phone, X-ray equipment or MRI devices are a
possible source of interference as they may emit higher levels of
electromagnetic radiation.
· Always install or carry the equipment properly to avoid damage caused by
drop, impact, strong vibration or other mechanical force.
· Dry the equipment immediately in case of rain or water spray. · Some settings are password protected and can only be changed by
authorized personnel. Contact your department manager or biomedical
engineering department for the passwords used at your facility.
· Do not loop the patient cabling into a tight coil or wrap around the device, as
this can damage the patient cabling.
· Dispose of the package material as per the applicable waste control
regulations. Keep it out of children's reach.
· At the end of its service life, the equipment, as well as its accessories, must be
disposed of in compliance with the guidelines regulating the disposal of such
products. If you have any questions concerning disposal of the equipment,
please contact us.
1.1.3
Notes
NOTE
· Put the equipment in a location where you can easily view and operate the
equipment.
· The equipment use a mains plug as isolation means to the mains power. Do
not locate the equipment in a place difficult to operate the mains plug.
· The typical operator's position is in front of the monitor. · The software was developed in compliance with IEC62304. The possibility of
hazards arising from software errors is minimized.
· This manual describes all features and options. Your equipment may not
have all of them.
· Keep this manual in the vicinity of the equipment so that it can be obtained
conveniently when needed.
1 - 3
1.2 Equipment Symbols
Some symbols may not appear on your equipment.
Caution
Serial number
Refer to instruction manual/ booklet
Direct current Battery indicator
USB connector
Date of manufacture
Alternating current Input/output Equipotentiality
DEFIBRILLATION-PROOF TYPE BF APPLIED PART Gas inlet Graphical record NIBP Start/Stop key Stand-by
General warning sign
DEFIBRILLATION-PROOF TYPE CF APPLIED PART Gas outlet Alarm Reset Admit patient Computer network
Temperature limit
1 - 4
Atmospheric pressure limitations
This way up
Humidity limitations Keep away from rain
Fragile, handle with care
Stacking limit by number
Non-ionizing electromagnetic radiation
Dispose of in accordance to your country's requirements
Manufacturer
Plastic identification symbol
Authorized representative in the European Community Medical Device
The product bears CE mark indicating its conformity with the provisions of the REGULATION (EU) 2017/745 on medical devices and fulfills the general safety and performance requirements of Annex I of this regulation. Note: The product complies with the Council Directive 2011/65/EU.
TrueBP is Mindray's new non-invasive blood pressure measurement algorithm using linear inflation technology, which can measure the blood pressure quickly and comfortably during cuff inflation.
TrueResp is Mindray's new respiration algorithm using pulse wave amplitude variation from SpO2.
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2 Equipment Introduction
2.1
2.2 2.3 2.4
Intended Use
The VS 9/VS 9A/VS 9C/VS 8/VS 8A/VS 8C Vital Signs Monitors are intended for monitoring, displaying, reviewing, storing, alarming, and transferring of multiple physiological parameters including Temperature (Temp), Pulse Oxygen Saturation (SpO2), Pulse Rate (PR), Respiration Rate (RR), Non-invasive Blood Pressure (NIBP), Carbon Dioxide (CO2). All the parameters can be monitored on single adult, pediatric, and neonatal patients.
The monitors are to be used in healthcare facilities by clinical professionals or under their guidance. They should only be used by persons who have received adequate training in their use. VS 9/VS 9A/VS 9C/VS 8/VS 8A/VS 8C Vital Signs Monitors are not intended for helicopter transport, hospital ambulance, or home use.
NOTE
· According to the conclusion of clinical evaluation and residual risk
evaluation, for the intended patients, there is no known side effects that can occur during or after the use of the medical device. And there is no need for the operator to make extra preparations. Thus, no residual risk associated with using the medical device should be disclosed due to the risk management report.
Intended Users
The VS Series Monitors are to be used in healthcare facilities by clinical professionals or under their guidance. They should only be used by persons who have received adequate training in their use.
Intended patient population
The VS 8/VS 8A/VS 8C/VS 9/VS 9A/VS 9C Vital Signs Monitors are applicable for single adult, pediatric, and neonatal patients.
Intended Medical conditions
The VS Series Monitors are expected to be used in medical institutions, and its application fields include: emergency care, internal medicine and surgical care, neonatal care, elderly care, Ambulance Surgical Center, postoperative recovery, Physician Office.
2 - 1
2.5 2.6
2.7
The VS Series Monitors are not intended for helicopter transport, hospital ambulance, or home use.
Contra-indications
None.
Applied Parts
The applied parts of the monitor are: SpO2 sensor Temp probe NIBP cuff CO2 sampling line/nasal sampling cannula
Main Unit
2.7.1 Front View (VS 9 Series)
1
2
43 1. Alarm indicator
2 - 2
2.7.2
When a physiological alarm or a technical alarm occurs, this indicator will flash as defined below.
High priority alarm: the lamp quickly flashes red. Medium priority alarm: the lamp slowly flashes yellow. Low priority alarm: the lamp is cyan without flashing.
2. Display screen
3. AC power indicator
On: indicates that the monitor is connected to the AC power. Off: indicates that the monitor is not connected to the AC power.
4. Battery LED Green: the battery is fully charged. Yellow: the battery is being charged. Flashing green: the monitor runs on battery power. Flashing yellow: the battery malfunctions. Off: no battery is installed, or the AC mains is not connected when the monitor is powered off.
Front View (VS 8 Series)
10
9
1 2
345 6 7
8
2 - 3
1. Power on/off indicator
On: indicates that the monitor is on or on Standby. Off: indicates that the monitor is off.
2. Power switch
Press this key to turn the monitor on.
When the monitor is on, if no measurement is being performed, press this key to enter standby mode.
When the monitor is on, press and hold this key for above 3 seconds to turn
the monitor off.
3. AC power indicator
On: indicates that the monitor is connected to the AC power. Off: indicates that the monitor is not connected to the AC power.
4. Battery LED Green: the battery is fully charged. Yellow: the battery is being charged. Flashing green: the monitor runs on battery power. Off: no battery is installed, or the AC mains is not connected when the monitor is powered off.
5. Alarm Reset/Pause key
Press this key to reset the alarm system. Press and hold this key for more than 2 seconds to pause or resume alarms.
6. NIBP Start/Stop key
Press to start or stop NIBP measurement.
7. Admit patient key
Press this key to admit a new patient.
8. Knob
Rotate the knob clockwise or counterclockwise to switch to another screen
element.
Press the knob to select one item, such as accessing a menu or confirming
the selection.
9. Display screen
10. Alarm indicator When a physiological alarm or a technical alarm occurs, this indicator will flash as defined below.
2 - 4
2.7.3
High priority alarm: the lamp quickly flashes red. Medium priority alarm: the lamp slowly flashes yellow. Low priority alarm: the lamp is cyan without flashing.
Side View (VS 9 Series)
1
2
3
7
6
1. Handle
4
5
2. Recorder
3. SpO2 cable connector
4. CO2 gas outlet
5. CO2 sampling line connector
6. Power switch
Press this key to turn the monitor on.
When the monitor is on, if no measurement is being performed, press this key to enter standby mode.
When the monitor is on, press and hold this key for above 3 seconds to turn
the monitor off.
An indicator is built in this switch. It turns on when the monitor is on and turns off when the monitor is off.
2 - 5
2.7.4
7. NIBP cuff connector
Side View (VS 8 Series)
1
6 5
2
3
4 1. Handle 2. Recorder 3. SpO2 cable connector 4. NIBP cuff connector 5. USB connector 6. Network connector
2 - 6
2.7.5 Rear View (VS 9 Series)
6 1
5 23 4 1. Equipotential grounding terminal When the equipment and other devices are to be used together, their equipotential grounding terminals should be connected together to eliminate the potential difference between them. 2. USB connector 3. Network connector 4. Multi-function connector 5. External battery connector 6. AC power input
2 - 7
2.7.6 Rear View (VS 8 Series)
1
2
3
4
1. Multi-function connector 2. Connector for an external battery 3. AC power input
4. Equipotential grounding terminal When the equipment and other devices are to be used together, their equipotential grounding terminals should be connected together to eliminate the potential difference between them.
2 - 8
3 Getting Started
3.1
Equipment Preparation Safety Information
WARNING
· Use only installation accessories specified by Mindray. · The equipment software copyright is solely owned by Mindray. No
organization or individual shall resort to modifying, copying, or exchanging it or to any other infringement on it in any form or by any means without due permission.
· Connect only approved devices to this equipment. Devices connected to the
equipment must meet the requirements of the applicable IEC standards (e.g. IEC 60950 safety standards for information technology equipment and IEC 60601-1 safety standards for medical electrical equipment). The system configuration must meet the requirements of the IEC 60601-1 medical electrical systems standard. Any personnel who connect devices to the equipment's signal input/output port are responsible for providing evidence that the safety certification of the devices has been performed in accordance to the IEC 60601-1. If you have any questions, please contact Mindray.
· The monitor and parameter monitoring accessories are suitable for use
within the patient environment. For other equipment and accessories connected to the monitor, consult corresponding manufacturers for the suitability within the patient environment.
· If it is not evident from the equipment specifications whether a particular
combination with other devices is hazardous, for example, due to summation of leakage currents, please consult the manufacturer or an expert in the field. A determination must be made that the proposed combination will not negatively affect the devices themselves or the patient's safety.
· If the accuracy of any value displayed on the monitor, central station, or
printed on a report is questionable, determine the patient's vital signs by alternative means. Verify that all equipment is working correctly.
CAUTION
· The equipment should be installed by authorized Mindray personnel. · When disposing of the packaging material, be sure to observe the applicable
waste control regulations and keep it out of children's reach.
3 - 1
3.2 3.3
· Before use, verify whether the packages are intact, especially the packages of
single use accessories. In case of any damage, do not apply it to patients.
· Avoid rude handling during transport. · Observance of this manual is a prerequisite for proper product performance
and correct operation and ensures patient and operator safety.
NOTE
· Put the equipment in a location where you can easily view and operate the
equipment.
· Keep this manual in the vicinity of the equipment so that it can be
conveniently referenced when needed.
· Save the packing case and packaging material as they can be used if the
equipment must be reshipped.
Unpacking and Checking
Before unpacking, examine the packing case carefully for signs of damage. If any damage is detected, contact the carrier or us.
If the packing case is intact, open the package and remove the equipment and accessories carefully. Check all materials against the packing list and check for any mechanical damage. Contact us in case of any problem.
NOTE
· If your monitor contains the internal CO2 module, connect the CO2 adapter to
the CO2 receptacle soon after you unpack the monitor to avoid losing the CO2 adapter.
Environmental Requirements
The operating environment of the equipment must meet the requirements specified in this manual.
The environment where the equipment is used shall be reasonably free from noises, vibration, dust, corrosive, flammable and explosive substances. Moreover, to maintain good ventilation, the equipment shall be at least 2 inches (5cm) away from around the cabinet.
When the equipment is moved from one place to another, condensation may occur as a result of temperature or humidity difference. In this case, never start the system before the condensation disappears.
3 - 2
CAUTION
· Make sure that the equipment operating environment meets the specific
requirements. Otherwise unexpected consequences, e.g. damage to the equipment, could result.
3.4
3.4.1
Setting Up the Equipment
Observance of this manual is a prerequisite for proper product performance and correct operation. It ensures patient and operator safety.
Installing a Battery
It is recommended to always install a fully charged battery in the monitor to ensure normal monitoring in case of accidental power failure. Follow this procedure: VS 9 series monitors: 1. Make sure the monitor is off and disconnected with any cable. 2. Lay the monitor down to expose the bottom of the monitor. 3. Open the battery compartment door.
4. Turn the latch aside. 5. Insert the battery into the battery compartment with the battery terminal inwards. 6. Turn the latch back to the middle and close the battery door. VS 8 series monitors: 1. Make sure the monitor is off and disconnected with any cable. 2. Lay the monitor down to expose the bottom of the monitor. 3. Open the battery compartment door.
3 - 3
3.4.2
4. If a 2500 mAh battery is used, put a battery support into the battery compartment. If a 5000 mAh battery is used, the support is not needed.
5. Insert the battery into the battery compartment with the battery terminal outwards. Then connect the battery to the connectors on the left of the battery compartment.
6. Close the battery door.
Connecting the AC Mains
Before connecting the equipment to the AC mains, check that the voltage and frequency ratings of the power line are the same as those indicated on the monitor.
To connect the monitor to the AC power source, follow this procedure:
1. Connect the monitor to the female end of the power cord, and the male end of the power cord to a wall AC outlet.
2. Check that the external power supply indicator is on.
The external power supply indicator lies in the lower right corner of the display. When the AC mains is not connected, the external power supply indicator is off. When AC mains is connected, the external power supply indicator is illuminated in green.
WARNING
· Always use the accompanying power cord delivered with the monitor. · Before connecting the equipment to the AC mains, check that the voltage
and frequency ratings of the power line are the same as those indicated on
the monitor.
· Use the cable retainer to secure the power cord to prevent it from falling off. · Use the battery if the integrity of the protective earth conductor or the
protective earthing system in the installation is in doubt.
3 - 4
3.4.3 3.4.4
3.5
Connecting a Barcode Reader
The monitor supports both linear (1D) barcode reader and two-dimension (2D) barcode reader. The barcode reader is connected to the monitor via the USB connector.
Connecting a Digital Scale
You can connect a HEALTH O METER 600KL-BT scale via the USB connector to obtain the height, weight, and BMI data of a patient.
Turning on the Monitor
Before turning on the monitor, perform the following inspections:
1. Check the monitor for any mechanical damage. Make sure that all external cables, plug-ins and accessories are properly connected.
2. Connect the monitor to the AC power source. Make sure the battery power is sufficient if the monitor is powered by the battery.
3. Press the power switch to turn on the monitor.
The monitor automatically performs a self test at startup. Check that the alarm tone is heard and the alarm lamp illuminates, one after the other, in red, yellow, and cyan. This indicates that the visible and audible alarm indicators function correctly.
CAUTION
· Check that visual and auditory alarm signals are presented correctly when
the equipment is powered on. Do not use the patient monitor for any monitoring procedure on a patient if you suspect it is not working properly, or if it is mechanically damaged. Contact your service personnel or us.
3.6
Start Wizard
When the monitor is started for the first time, a start wizard is launched to help set up your monitor. You can:
Set the system language: select a language from the list and then select .
Set the Temp type: select the Temp module of your monitor and then select .
Select Import Configuration if a preferred configuration has been exported and saved in a USB drive. For details, refer to 5.5.2 Importing a Configuration.
Select Create New Configuration to: Set the system time: for details of the settings, see 3.9.7 Setting the Date and Time. Set parameter units: for details of the settings, see 3.9.8 Setting Parameter Units.
3 - 5
Set the department of your monitor: the default configurations are department-oriented. Select a department and then select .
After completing the above settings, you can select:
Restart to use: the monitor restarts and enters normal working mode.
Advanced Settings: you can continue to set the network and workflow. For more information about workflow setting, refer to 3.9.2 Setting the Workflow.
Export Configuration: you can export the current configuration to a USB drive. Before selecting this option, connect a USB drive to the USB connector first. For details, refer to 5.5.1 Exporting a Configuration.
3.7
Operation and Navigation
Everything you need to operate the monitor is on its screen. Almost every element on the screen is interactive. Screen elements include parameter values, waveforms, quick keys, information fields, alarms fields and menus. Often you can access the same element in different ways. For example, you can access a parameter menu by selecting corresponding numeric area or waveform area, or by selecting the Main Menu quick key from the Parameters column select Setup.
3.7.1
Using the Touchscreen
For monitors configured with touchscreen, you can touch the screen or swipe across the screen with your fingers to operate the monitor.
3.7.1.1
Tapping the screen or Swiping across the Screen
Tapping the screen
To select an item from menus or lists, or select a quick key, tap on it with your finger.
To enter a parameter menu, tap corresponding numeric area or waveform area. For example, select the NIBP area to enter the NIBP menu.
Swiping across the screen with a single finger:
To scroll through a list and a menu, swipe up and down. To show more pages of a screen, such as the Main Menu screen, swipe left
or right to switch between the two setup pages.
3.7.1.2
Locking the Touchscreen
To avoid misuse, you can temporarily disable the touchscreen. To do so, hold and press the Main Menu quick key and slide as directed by the arrow. When the touchscreen is
locked, the Main Menu quick key changes to .
The touchscreen lock period is configurable. To do so, follow this procedure: 1. Select the Main Menu quick key from the Display column select Display.
3 - 6
2. Set Screen Lock Duration. 1 min, 30 sec, 20 sec or 10 sec: a countdown clock is displayed after the touchscreen is locked. The touchscreen is enabled when the preset time is reached. Permanent: the touchscreen can only be enabled manually.
If you need to manually enable the touchscreen:
1. Tap anywhere on the touchscreen.
2. Press and slide it to the position.
CAUTION
· Check that the touchscreen is not damaged or broken. If there is any sign of
damage, stop using the monitor and contact the service personnel.
· Wipe off the water on the touchscreen in case of rain or water spray.
3.7.2 3.7.3
3.7.4
Using the Knob (For VS 8 Series)
VS 8 series monitors, configured with touchscreen or not, provide a navigation knob and four hardkeys. For detailed descriptions, refer to 2.7.2 Front View (VS 8 Series).
Using the On-Screen Keyboard
The on-screen keyboard enables you to enter information:
Enter the information by selecting one character after another.
Select the Backspace key the entire entry.
to delete single characters or select to delete
Select the Caps Lock key to access uppercase letters.
Select the Enter key to confirm the entry and close the on-screen keyboard.
Select to show the password that has been input.
Using the Barcode Reader
The monitor supports both linear (1D) barcode reader and two-dimension (2D) barcode reader. The barcode reader is connected to the monitor through the USB connector.
If you are using the Mindray custom 2D barcode reader (Model HS-1R or HS-1M), before using the it for the first time, clear old data formats and configure the barcode reader.
Before configuring the Mindray custom barcode reader, clear old data formats. To do so, follow this procedure:
1. Scan the engineering barcode to clear the previous data format.
2. Scan the 2D engineering barcode which contains your hospital's data format.
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NOTE
· Contact the scanner manufacturer or Mindray to obtain the engineering
barcodes for clearing data formats and containing the hospital's data format.
3.8 Screen Display
3.8.1 Main Screen
5
1
6
7
2
8
3
4
1. Workflow area: displays the current workflow. Select this area and you can switch to another workflow.
2. Patient information area: displays patient information, including patient ID, name, gender and so on. The displayed patient information is configurable. Selecting this area enters the Patient Management menu.
3. Parameter area: displays parameter values, waveforms, alarms and so on. Selecting a parameter area to display the corresponding parameter menu.
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3.8.2
4. Quick key area: displays quick keys. These keys may vary according to the workflow settings.
5. Alarm information area: displays physiological alarms on the above, and prompt messages and technical alarms at the bottom.
6. System status information area: displays symbols indicating the battery status, network status, blue tooth status etc.
7. System time: displays the current system time. 8. Clinician information: displays login information of clinician. Select this area to log
in or out.
Menus
All menus have similar style and structure, see the figure below:
1
5
2
3
6
4
1. Menu heading 2. Tabs: enters submenus 3. Main body area: includes menu items and options. 4. Operation buttons 5. Exit button: closes the current menu page. 6. Switch:
Green: the switch is on. Gray: the switch is off.
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3.8.3
Quick Keys
The monitor provides quick keys for you to quickly access some functions. The quick key area is located at the bottom of the screen. These keys may vary according to the workflow settings.
The following table shows available quick keys.
Symbol Label Review
Function
Enters the Review menu.
Symbol Label Patient
Function
Displays the patient list.
Save
Saves the input information.
Clear
Clears all input information.
Main Menu
Next
Enters the main unit.
Shows the next screen.
More Back
Alarm Pause
Pauses the physiological alarms.
Alarm Reset
Targeted Enters the Targeted Goal screen. Goal
Shows more quick keys.
Shows the previous screen.
Resets the alarm system.
3.8.4
On-screen Symbols
The following table lists the on-screen symbols:
Symbol
Description Adult, male (blue)
Symbol
Description Adult, female (pink)
Pediatric, male (blue)
Pediatric, female (pink)
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Symbol
Description Neonate, male (blue)
Symbol
Description Neonate, female (pink)
Wired network is connected.
All alarms are paused.
Audible alarm tones are paused.
Audible alarm tones are turned off.
Wireless network is connected. The solid part indicates network signal strength. Press this button to select another available network, if any. Bluetooth device is connected.
Wired network is not connected.
Individual physiological alarms are turned off or the monitor is in the alarm off status Alarms are acknowledged and the alarm is reset.
CMS is connected. Press this button to select another available CMS, if any. Wireless network cannot be connected.
Bluetooth function is enabled.
3.9
3.9.1
Configuring Your Monitor
Before putting your monitor in use, other preferential settings can be made to ease your operations.
Setting Device Location
To better locate and manage your monitor, you can set the location information. Follow this procedure:
1. Select the Main Menu quick key from the System column select Maintenance input the required password select . The Device Location tab is displayed.
2. Set Location. Fixed: the Patient Management menu displays Bed No and Room No, but you cannot change them. If your monitor is installed at a fixed position, or
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you do not need to frequently change the room number and bed number, set Location to Fixed. Unfixed: you can change Bed No and Room No from the Patient Management menu.
NOTE
· If Location is set to Unfixed, Bed No and Room No are cleared each time you
discharge a patient.
3. Input the Monitor Name, Facility, Department, Room No, Bed No.
3.9.2
Setting the Workflow
Workflow is a configuration user-definable basing on daily tasks to simplify the use of the monitor.
You can set the screen layout to select parameters displayed on the main screen and their positions.
You can also make preferential settings for each parameter. For workflows under Continuous Monitoring, you can change alarm settings.
Every time you switch to a workflow, the pre-defined settings are loaded.
3.9.2.1
Accessing the Workflow Setup Menu
Access the Workflow Setup menu in the following ways:
Select the Main Menu quick key from the Configuration column select Workflow input the required password select .
Select the Main Menu quick key from the Configuration column select
Manage input the required password select
Workflow Setup.
In the Workflow Setup menu, the currently set workflows are listed under the work modes. You can:
Select
to change the current workflow settings.
Select to add a copy of the current workflow.
Select to delete a workflow.
Select Add Workflow to create a new workflow.
NOTE
· You can save up to 10 workflows.
3.9.2.2
Setting the Screen Layout
To set the parameters and their positions to be displayed on the screen, follow this procedure:
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1. In the Workflow Setup menu, select
on the right of the workflow to be set.
2. Select an area, and then from the popup list select the parameter to be displayed.
You can set up to 3 pages of screens and each page displays up to 4 rows of parameters, corresponding to the parameter areas displayed on the main screen.
Select to lock or unlock the first parameter of the first page. If locked, a is displayed and this parameter is displayed as the first parameter of
each page.
Select
to change the current row to a two-tile display area. The
previously selected parameter will be changed to Off.
Select
to change the current row to an undivided display area. The
previously selected parameters will be changed to Off.
3.9.2.3
Changing Parameter Settings
After setting the screen layout, you can make preferential settings for each parameter on the monitor. To access the Parameters Setup menu, in the Edit Workflow menu, select Parameters Setup.
The settings under the tabs might be different for different departments and work modes. For details, see the table below:
Tab
Menu Item
Description
Work Mode
NIBP
NIBP End Tone
If enabled, a reminder tone is issued at the Both
completion of NIBP measurement.
Display Format
Selects the type and sequence of displayed NIBP readings.
Both
Initial Pressure (Neo)
Sets the initial cuff inflation pressure for neonatal patients.
Both
Measurements
Sets the number of measurement that can be performed in Manual NIBP Measurement. For details, see 11.7.1 Performing Manual Measurement.
Spot Check
Interval
Sets the interval between two auto NIBP measurement.
Continuous Monitoring
Start Mode
Defines how NIBP auto mode works. For details, see 11.8.3 Selecting NIBP Start Mode--not a task.
Continuous Monitoring
Display Alarm Limits
Sets whether to display the alarm limits of diastolic NIBP and mean NIBP.
Continuous Monitoring
Patient Position
Sets the patient position for NIBP measurement.
Both
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Tab
Menu Item
Description
Work Mode
NIBP
Measurement Site Sets the measurement site for NIBP
Both
measurement.
Sequence
Sets the duration and interval of NIBP measurement sequences.
Continuous Monitoring
Orthostatic BP Measurement
Selects whether to enable Orthostatic BP measurement.
Spot Check
Lying Duration
Sets the time before starting lying BP measurement. Available only when Orthostatic BP Measurement is enabled.
Standing BP Measurement Interval
Sets the interval for automatic standing BP measurement. Available only when Orthostatic BP Measurement is enabled.
Maximum Standing BP Measurements
Sets the number of automatic standing BP measurement. Available only when Orthostatic BP Measurement is enabled.
BP Averaging
Selects whether to enable BP averaging. Available only when Department is set to Physician Office.
Spot Check
Number of Measurements
Sets the number of measurement to be performed in a group of BP measurements for averaging. Available only when Department is set to Physician Office.
Discard First Group of Readings
Selects whether to include the first group of readings in the averaging calculation. Available only when Department is set to Physician Office.
Delay Before Starting Measurement
Sets the time to wait before starting the first measurement. Available only when Department is set to Physician Office.
Time Between Readings
Sets the time to wait before starting the rest automatic BP measurement. Available only when Department is set to Physician Office.
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Tab SpO2
PR Temp RR
Menu Item
Description
Work Mode
Sensitivity
For Masimo SpO2 modules, see 8.6.4 Setting Both SpO2 Sensitivity (for Masimo SpO2). For Mindray SpO2 modules, see 8.6.8 Changing the Sensitivity (for Mindray SpO2).
Display PI
Sets whether to display PI in the SpO2 parameter area.
Speed
Sets the sweep speed of Pleth waveforms.
NIBP Simul
Switch on for patients performing SpO2 and NIBP monitoring on the same limb. The SpO2 alarm status is locked until the NIBP measurement ends.
Continuous Monitoring
Pulse Volume
Sets the pulse volume.
Both
Irr. PR Switch
Selects whether to enable the Irregular PR function. If enabled, you can mark the pulse as regular or irregular on the PR screen.
Spot Check
Measurement Site Sets the default measurement site for Temp Both
(Manual)
measurement.
Timer Reminder Interval
Sets the interval of reminder tone for the timer used for manual RR. For details, see 13.5.5 Setting Timer Interval.
Both
Apnea Delay (Adult)/(Ped)/ (Neo)
Sets the delay for giving an Apnea alarm.
Continuous Monitoring
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Tab
Menu Item
Description
Work Mode
CO2
Auto Standby
The CO2 module automatically enters
Continuous
standby mode after the configured period of Monitoring
time is no breath is detected since the last
detected breath.
BTPS Compensation
Enables or disables the BTPS (body temperature and pressure, saturated) compensation.
O2 Compensation
N2O Compensation
Sets the default concentration of interfering gas.
AG Compensation
Speed
Sets the speed of CO2 waveform.
CO2 Scale
Sets the scale of CO2 waveform.
Waveform Type Sets the type of CO2 waveform.
Pain
Default Method Sets the default pain scale for scoring.
Both
Pain Score Setup See 18.9.5 The Pain Score Tab.
EWS
Default Adult
Score
Sets the default scoring protocol for adult patients.
Spot Check
Default Ped Score Sets the default scoring protocol for pediatric patients.
Default Neo Score Sets the default scoring protocol for neonatal patients.
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Tab
Menu Item
Description
Work Mode
EWS(Ad Score ult)
Sets the default scoring protocol for adult patients.
Continuous Monitoring
Auto Scoring
Selects the condition to start auto scoring. If none of the options is checked, auto scoring is switched off. For details, see 15.1.4.2 Enabling Auto Scoring.
Interval
Sets the auto scoring interval. For details, see 15.1.4.3 Setting Auto Scoring Interval.
Auto Refresh Scores
Selects whether to enable the auto refreshing score function. For details, see 15.1.5.2 Auto Refreshing Scores.
Alarm EWS Score
Selects whether to enable EWS alarms. For details, see 15.1.5 EWS Alarm.
3 in single parameter
EWS(Pe Score d)/(Neo)
Auto Scoring
/
Selects the condition to start auto scoring. If none of the options is checked, auto scoring is switched off. For details, see 15.1.4.2 Enabling Auto Scoring.
Continuous Monitoring
Interval
Sets the auto scoring interval. For details, see 15.1.4.3 Setting Auto Scoring Interval.
Manual / Input
Selects the parameters and their position to Both be displayed in the Manual Input list.
Parameter Library See 17.9.4 The Manual Input Tab.
Both
Paramet NIBP er Color
SpO2
White Blue
Both Both
Temp
White
Both
CO2
Yellow
Continuous Monitoring
RR
Yellow
Both
3.9.2.4
Changing Alarm Settings
For workflows under Continuous Monitoring, you can enable or disable an alarm, and set the alarm limits and priorities of physiological alarms of each parameter.
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Follow this procedure:
1. After setting the screen layout, in the Edit Workflow menu, select Alarm Setup. 2. Select Adult, Ped, and Neo tabs to set the alarms for adult, pediatric and neonatal
patients.
NOTE
· SpO2 Desat and Apnea alarms cannot be disabled by default.
3.9.3
Adjusting Screen Brightness
To adjust the screen brightness, follow this procedure:
1. Select the Main Menu quick key from the Device column select Display.
2. If you are using the AC power, set Brightness. If you are using the battery to run the monitor, set Brightness On Battery. You can set the brightness to 1 to 10, in which 10 is the brightest, and 1 is the least bright.
If the monitor operates on battery power, you can set a less bright screen to prolong the operating time of the battery. When the monitor enters Standby mode, the screen will change to the least brightness automatically.
3.9.4 3.9.5 3.9.6
Adjusting the Volume
To adjust the volume, follow this procedure: 1. Select the Main Menu quick key from the Device column select Volume. 2. You can set Alarm Volume, Pulse Volume, and Key Volume. Select -/+ to
decrease or increase the volume or select to turn it off.
Changing Measurement Colors
You can set the color of measurement values and waveforms for each parameter. To do so, follow this procedure:
1. Select Main Menu quick key from the Parameters column select Parameter Color. The Current tab is displayed.
2. Set the colors of the currently monitoring measurement values and waveforms.
Setting System Language
To change the language setting, follow this procedure:
1. Select the Main Menu quick key from the System column select Maintenance
input the required password select
Other.
2. Select Language, and from the popup list, select the target language.
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3.9.7
Setting the Date and Time
To set the system time, follow this procedure: 1. Select the Main Menu quick key from the System column select Time.
2. Set Date and Time. 3. Set Date Format to yyyy-mm-dd, mm-dd-yyyy, or dd-mm-yyyy, in which:
yyyy indicates the year. mm indicates the month. dd indicates the day. 4. If you want to use the 12-hour mode, switch off 24-Hour Time.
5. If you want to use daylight savings time, switch on Daylight Savings Time. You can manually switch on or off the daylight savings time only when the auto daylight savings time function is disabled. For more information, see 18.11 The Time Settings.
CAUTION
· Changing the date and time affects the storage of trends and events and may
result in loss of data.
NOTE
· If your monitor is connected to a central monitoring system (CMS) or hospital
clinical system (HIS), the date and time are automatically taken from the CMS. In this case, you cannot change the date and time from your monitor.
3.9.8
Setting Parameter Units
To set the units, follow this procedure:
1. Select the Main Menu quick key from the System column select Maintenance
input the required password select
Unit.
2. Select a parameter, and from the popup list, select the unit to be used.
Below is a list of the units you can set:
Parameter Height Unit Weight Unit Glucose Unit
Options cm, inch kg, lb mg/dl, mmol/L
Default cm kg mg/dl
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Parameter I/O Fluid Unit CO2 Unit Temp Unit Pressure Unit
Options ml, L mmHg, kPa, % °C, °F mmHg, kPa
Default ml mmHg °C mmHg
3.9.9
3.10
Checking Software Licenses
To run the following functions in your monitor, software licenses are required: Orthostatic BP measurement Vitalslink Network Connectivity MLDAP SpO2 Calc RR To check the licenses, select the Main Menu quick key select License Local. To install the licenses, follow this procedure: 1. Connect the USB drive with the licenses in to the monitor's USB connector. 2. Select the Main Menu quick key select License select External. 3. Select Install.
Start Working
3.10.1
Selecting a Work Mode
The monitor provides spot check mode and continuous monitoring mode. It works based on the workflow you selected.
3.10.1.1
Continuous Monitoring Mode
The continuous monitoring mode is used for long-term patient monitoring. To switch to monitoring mode, select the workflow area and select a workflow under Continuous Monitoring.
3.10.1.2 Spot Check Mode
The spot check mode is intended for on-spot measurement in a short period. To switch to spot check mode, select the workflow area and select a workflow under Spot Check.
In spot check mode, physiological alarm system is disabled.
There will be no physiological alarm related indications.
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The alarm setup menus will not be displayed. Alarm limits cannot be set. Different features between continuous monitoring mode and spot check mode:
Functions
Configure and use Sat-Seconds (Nellcor) Access Alarm Setup tab Access Events tab Access Graphic Trends tab Auto data updating with the central monitoring system BP Averaging Orthostatic BP measurement Measure CO2 (VS 9 series) SpO2 sourced RR (Mindray SpO2 module)
Continuous Monitoring mode Spot check mode
Yes
No
Yes
No
Yes
No
Yes
No
Yes
No
No
Yes
No
Yes
Yes
No
No
Yes
3.10.1.3 Standby Mode
You can temperately stop patient monitoring without switching off the monitor by entering the standby mode. In standby mode, the monitor behaves as follows:
Stops all parameter measurement. Disables all the alarms and prompt messages, except for the battery low alarm. Turns screen brightness to the dimmest after entering the standby mode.
You can switch the monitor to standby mode manually, or set Auto Enter Standby for the monitor to enter standby mode automatically.
To switch the monitor to standby mode: 1. Press the power switch, or select the Main Menu quick key from the Patient
Management column select Standby.
2. If the monitor is in Continuous Monitoring mode, select a location in the drop down list to define where the patient is when the monitor enters the standby mode. If the monitor is in Spot Check mode, skip this step.
3. Select OK.
To set Auto Enter Standby:
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1. Select the Main Menu quick key from the System column select Maintenance input the required password select .
2. Select the Standby tab, switch on Auto Enter Standby, and set the Auto Enter Standby Time.
After setting, the monitor enters standby mode automatically if no operation is detected after the Auto Enter Standby Time.
WARNING
· Pay attention to the potential risk of placing the monitor to standby. In the
standby mode, the monitor stops all parameter measurement and disable all the alarm indications, except for the battery low alarm.
If the monitor enters standby mode in Continuous Monitoring mode, you can: Change the patient location from the standby screen. Select Discharge Patient on the standby screen to discharge a patient. Select Resume monitor on the standby screen to exit the standby mode. If the monitor enters standby mode in Spot Check mode, you can select anywhere on the touchscreen to exit the standby mode.
3.10.2
Inputting Patient Information
It is recommended to input the patient information correctly before monitoring. Follow this procedure:
1. Select patient information area and the Patient Management menu is displayed. 2. Input the Patient ID, name, date of birth, Patient Category, and Gender. 3. Select OK.
3.10.3
Accessing Parameter Setup Menus
Each parameter has a setup menu in which you can adjust the alarm and parameter settings. You can enter a parameter setup menu by using the following methods:
In Continuous Monitoring mode, select the parameter area to display a parameter setup menu.
In Spot Check mode, select the Main Menu quick key from the Parameters column select Setup select the desired parameter.
3.10.4
Checking the Alarm Settings
For patients under continuous monitoring, make sure the alarm limits are appropriate for the currently admitted patient. To check the alarm limits, in Continuous Monitoring
3 - 22
mode, select the Main Menu quick key from the Alarm column select Limits. Change them if necessary.
3.11
Stopping a Parameter Measurement
To stop monitoring a parameter, follow this procedure: 1. Remove corresponding sensors from the patient. 2. Disconnect the sensor from the patient cable. 3. Disconnect the patient cable from the parameter connector. 4. If you are using the disposable sensor, discard it.
3.12
Turning Off the Monitor
Before turn off the monitor, perform the following check: 1. Ensure that the monitoring of the patient has been completed. 2. Disconnect the cables and sensors from the patient. 3. Make sure to save or clear the patient monitoring data as required. To turn off the monitor, press and hold the power switch for 3 seconds. Turning off the monitor does not disconnect the monitor from the AC mains. To completely disconnect the power supply, unplug the power cord.
CAUTION
· Press and hold the power switch for 10 seconds to forcibly shut down the
monitor if it could not be shut down normally. This may cause loss of patient data.
NOTE
· In case of a temporary power failure, if the power is restored within 30
minutes, monitoring will resume with all active settings unchanged; if the monitor is without power for more than 30 minutes, the monitor behaves the same as it is normally turned off.
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4 Managing Patients
4.1
The monitor provides patient management functions. On the monitor, you can admit and discharge a patient, and edit, review, import, and export patient information.
Admitting a Patient
4.1.1
Automatically Admitting a Patient
The monitor admits a new patient automatically when started for the first time or after a patient is discharged. For automatically admitted patient, you need to input and save the patient information so the measurements and other physiological data could be correctly saved to the patient.
Always inputs patient information as soon as the patient is admitted. For more information, see 4.2.2 Editing Patient Information for details.
WARNING
· The setting of patient category always contain a default value, regardless of
whether the patient is admitted or not. Check if the setting is correct for your patient.
4.1.2
Manually Admitting a Patient
You can admit a patient from ADT Database (if available) and Local Patient List. You can also admit a new patient. Follow this procedure:
1. Select Patient quick key.
2. Select a patient from the list and then select Admit to admit a patient. Or, select Add New to admit a new patient.
3. Check or modify the information of the patient. Select OK.
WARNING
· Before admitting a patient, make sure the data for the current patient is
properly edited and saved. Failure to do so can lead to data being attributed to the wrong patient.
4 - 1
4.2 Managing Patient Information
4.2.1 4.2.2
Entering the Patient Management Menu
Use any of the following methods to enter the Patient Management menu:
Select the patient information area at the top left corner of the screen. Select the Main Menu quick key from the Patient Management column select
Patient Management.
Editing Patient Information
Edit patient information after a patient has been admitted, or when patient information is incomplete, or when you want to change patient information.
To edit patient information, follow this procedure:
1. Enter the Patient Management menu. For more information, see 4.2.1 Entering the Patient Management Menu.
2. Edit patient information as required.
If you connect a barcode reader with your monitor, you can scan the patient's barcode to enter the patient's information.
Input the Patient ID or Visit Number of a patient, other information will automatically fill in if the patient is in the Local Patient List or ADT Database (if the monitor is connected with the Admit-Discharge-Transfer (ADT) server through the eGateway).
NOTE
· The monitor will reload the configuration if you changed the patient
category.
4.3
Discharging a Patient
The monitor discharges a patient in the following situations:
After a patient is manually admitted, the previous patient is automatically discharged.
In Spot Check mode, a patient is discharged if the monitor is powered off or workflow is switched.
For patients under Continuous Monitoring mode, you can let the monitor automatically discharge after the monitor has been switched off for a period of time. The configuration of this function is password protected. For more information, see 18.3.3 The Discharge Tab.
If the monitor has not detected certain patient vital signs (SpO2, PR, RR, NIBP) for 30 minutes, you will be prompted whether to start monitoring a new patient if any of the above vital signs are detected again.
4 - 2
When a patient is discharged, all patient data, including patient information, trend data, and physiological alarm information is deleted from the monitor. The technical alarms is reset, and monitor settings returns to their defaults.
NOTE
· Discharging a patient deletes all history data from the monitor.
4.3.1 4.3.2 4.3.3
Manually Discharging a Patient
Patients under Continuous Monitoring mode can be discharged manually. Follow this procedure:
1. Make sure all the patient data needed is properly saved.
2. Select the patient information area at the top left corner of the screen. 3. Select Discharge Patient.
Auto Discharging a Patient after Monitor Power Off
For patients under Continuous Monitoring mode, you can set the monitor to automatically discharge a patient upon startup after being switched off for a period of time. Follow this procedure: 1. Select the Main Menu quick key from the System column select Maintenance
input the required password select . 2. Select the Patient Management tab select the Discharge tab.
3. Select a time for Auto Discharge When Power Off. The monitor will automatically discharge the patient at next startup after being switched off for the selected period of time. The default is Never. That is to say the monitor will not discharge a patient upon startup no matter for how long the monitor has been switched off.
Changing Patient Management Settings
You can define which items can be displayed and edited from the Patient Management menu. To do so, follow this procedure: 1. Select the Main Menu quick key from the System column select Maintenance
input the required password select .
2. Select the Patient Management tab.
3. Select the fields you want to display in the Patient Management menu.
4. If necessary, select the customized fields and input names for these fields.
NOTE
· If the monitor is connected with the CMS, the patient information items and
customized fields are loaded from the CMS.
4 - 3
4.3.4
Setting Monitor Information
To set monitor information, follow this procedure: 1. Select the Main Menu quick key from the System column select Maintenance
input the required password select .
2. Select the Device Location tab.
3. Input monitor name, facility name and department name.
4.3.5
4.4
Setting Patient Location
To set patient location, follow this procedure: 1. Select the Main Menu quick key from the System column select Maintenance
input the required password select . 2. Select the Patient Management tab. 3. Select the Location tab. 4. Input patient location as desired.
Deleting Patient Data
To delete the data of discharged patients, follow this procedure: 1. Select the Patient quick key. 2. Select Select Patient. From the patient list select desired patients. 3. Select Delete.
4 - 4
5 Managing Configurations
5.1
Configuration Introduction
When performing measurement or continuously monitoring on a patient, the clinical professional often needs to adjust the monitor's settings according to the patient's condition. The collection of all these settings is called a configuration. The system configuration items can be classified as: parameter configuration items, conventional configuration items, and user maintenance items. Allowing you to configure the monitor more efficiently, the monitor provides different sets of configurations to accommodate the varying patient categories and departments. You can change some settings from a certain set of configuration and then save the changed configuration as a user configuration.
The default configurations provided for your monitor are department-oriented. You can choose any of the following department:
Wards
Emergency Department
Physician Office
Ambulatory Surgery Center
WARNING
· The configuration management function is password protected. The
configuration management tasks must be performed by clinical professionals.
5.2
Changing the Department
If the current department configuration is not the one you want to view, you can change the department by following this procedure: 1. Select the Main Menu quick key from the Configuration column select
Manage input the required password select .
2. Select Department Type.
3. Select a department. 4. Select OK.
5 - 1
CAUTION
· Changing the department will delete all current user configurations.
5.3 5.4 5.5
5.5.1
5.5.2
Setting Default Patient Category
To set the default patient category when admitting a new patient, follow this procedure: 1. Select the Main Menu quick key from the Configuration column select
Manage input the required password select . 2. Set Default Patient Category.
Setting Workflows
For details, refer to 3.9.2 Setting the Workflow.
Transferring a Configuration
When installing several monitors with identical user configurations, it is not necessary to set each unit separately. Use a USB drive to transfer the configuration from monitor to monitor.
Exporting a Configuration
To export the current monitor's configuration, follow this procedure: 1. Connect a USB drive to the monitor's USB port. 2. Select the Main Menu quick key from the Configuration column select
Manage input the required password select . 3. Select Export Configuration. 4. Select the workflows and User Maintenance Settings to export. 5. Select Export.
Importing a Configuration
To import the configuration from the USB drive to the monitor, follow this procedure: 1. Connect the USB drive to the monitor's USB connector. 2. Select the Main Menu quick key from the Configuration column select
Manage input the required password select . 3. Select Import Configuration. 4. Select the workflows and User Maintenance Settings to import. 5. Select Import.
5 - 2
5.6 5.7
Modifying Configuration Password
To modify the configuration password, follow this procedure: 1. Select the Main Menu quick key from the Configuration column select
Manage input the required password select .
2. Select Modify Password.
3. Respectively input the old password and new password.
4. Select OK.
Restoring the Latest Configuration Automatically
During operation, you may make changes to some settings. However, these changes may not be saved as user configuration. To prevent the changes from losing in case of a sudden power failure, the equipment stores the configuration in real time. The saved configuration is the latest configuration.
In case of a temporary power failure, if the power is restored within 30 minutes, monitoring will resume with all active settings unchanged; if the monitor is without power for more than 30 minutes, the monitor behaves the same as it is normally turned off.
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6 Networked Monitoring
6.1 6.2
Network Introduction
You can connect the monitor to the central monitoring system (CMS), and eGateway through wired LAN or wireless LAN.
Network Safety Information
CAUTION
· Wireless network designing, deploying, debugging, and maintenance should
be executed by Mindray service personnel or authorized technicians.
· Always set the wireless network according to local wireless regulations. · Using 5G frequency band is recommended whenever possible. There are
more interference sources in 2.4G frequency band.
· Private APs and wireless routers are not allowed. These devices may cause
radio interference and result in monitor and CMS data loss.
· Data communication must be performed within a closed network or within a
virtually isolated network provided by a hospital for all network functions. The hospital is responsible for ensuring the security of the virtually isolated network.
· WPA2-PSK and WPA2-Enterprise verification and encryption should be used
if possible. Otherwise, the equipment may not be able to work or patient information may be divulged. WPA2-Enterprise and a long password are recommended.
· Keep network authentication information, for example password, safe,
protecting the network from being accessed by unauthorized users.
· Do not connect non-medical devices to the monitor network. · If wireless network signal is poor, there may be a risk of CMS data loss. · RF interference may result in wireless network disconnection. · Maximum number of monitors connected to a single AP is 16. Too many
monitors connected to the same AP may result in network disconnection.
· Disconnecting from the network may result in CMS data loss and function
failure. Check the patient in case of network disconnection and solve the network problem as soon as possible.
6 - 1
6.3
6.4 6.5
· Ensure that the monitor IP address setting is correct. Changing the network
settings may result in network disconnection. Contact your service personnel if you have any problems on setting the IP address.
Connecting the Monitor to the CMS
You can connect the monitor to the BeneVision CMS. When connected to the CMS, the system provides the following function.
The monitor can transmit parameter values, waveforms, alarm settings (if the monitor is working in Continuous Monitoring mode), and events to the CMS. From the CMS, you can check the patient's data and alarms (if any).
When the monitor is working in Continuous Monitoring mode, patient information, alarm settings, and alarm status can be synchronized between the monitor and the CMS.
You can start or stop NIBP measurement from the CMS. In case of network disconnection, the monitor can transmit the offline data to the
CMS when network is reconnected.
For more information on the CMS, see the operator's manual of corresponding central monitoring system.
To select a CMS, select the system status information area at the top right corner of the main screen. Select the desired CMS from the popup CMS list.
NOTE
· You can select CMS only when the Select CMS switch is on. For more
information, refer to 18.16.5 The Transfer Setup Tab.
Connecting the eGateway
You can connect the monitor to the eGateway to implement interaction between the monitor and external devices. When connected to the eGateway, the system provides the following functions:
The monitor can transmit parameter values, waveforms, alarm settings (if the monitor is working in Continuous Monitoring mode), and events to the eGateway.
Clock can be synchronized between the monitor and the eGateway.
MLDAP
MLDAP refers to Mindray LDAP (Lightweight Directory Access Protocol). It is an independent process which can be installed on eGateway or other application server (Windows). MLDAP provides user identity and authentication.
6 - 2
6.6
The MLDAP server is connected with the hospital LDAP server. All monitoring devices are connected to the MLDAP server to implement identity and authentication for the following operations:
Changing alarm settings Accessing the Maintenance menu For details about the settings, see 18.16.8 The MLDAP Tab.
Connecting the Wireless Network
You can add up to five wireless networks for the monitor. If connecting the current wireless network fails, the monitor automatically connects other wireless networks in the order when they were added.
To manually switch the wireless network, from the system status information area on the top right corner of the screen select , and select the desired wireless network.
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6 - 4
7 Alarms
7.1 7.2
Alarm Introduction
This chapter describes alarm functions and alarm settings. Physiological alarms are available only when the monitor is in Continuous Monitoring mode.
Alarm Safety Information
WARNING
· A potential hazard can exist if different alarm presets and default
configuration settings are used for the same or similar equipment in the same care area, for example an intensive care unit or cardiac operating room.
· If your monitor is connected to the central monitoring system (CMS), alarms
can be presented and controlled remotely. Remote suspension, inhibition, or reset of monitor alarms via the CMS may cause a potential hazard. For more information, see the operator's manuals of the CMS.
· The monitors in your care area may each have different alarm settings to suit
different patients. Always check that the alarm settings are appropriate for your patient before start monitoring. Always make sure that necessary alarm limits are active and set according to the patient's clinical condition.
· Setting alarm limits to extreme values may cause the alarm system to
become ineffective. For example, high oxygen levels may predispose a premature infant to retrolental fibroplasia. If this is a consideration do not set the SpO2 high alarm limit to 100%, which is equivalent to switching the alarm off.
· When the alarm sound is switched off, the monitor gives no alarm tones even
if a new alarm occurs. Be careful about whether to switch off the alarm sound or not. When the alarms are off or while alarm audio is paused either temporarily or indefinitely, observe the patient frequently.
· When monitoring patients that are not continuously attended by a clinical
operator, properly configure the alarm system and adjust alarm settings as per the patient's condition.
· Do not rely exclusively on the audible alarm system for monitoring.
Adjustment of alarm volume to a low level may result in a hazard to the patient. Always make sure that the audio alarm volume level is adequate in your care environment. Always keep the patient under close surveillance.
7 - 1
7.3 Understanding the Alarms
7.3.1 7.3.2 7.3.3
Alarm Categories
The monitor has two different types of alarms: physiological alarms and technical alarms.
Physiological alarms are triggered by patient measurement exceeding the parameter limits, or by an abnormal patient conditions.
Technical alarms are triggered by an electrical, mechanical, or other monitor failure, or by failure of a sensors or components. Technical alarm conditions may also be caused when an algorithm cannot classify or interpret the available data.
Apart from the physiological and technical alarms, the monitor can also prompt some messages telling the system status or patient status.
Alarm Priorities
By severity, the alarms are classified into the following priority levels:
High priority alarms: indicates a life threatening situation or a severe device malfunction. High priority alarms require an immediate response.
Medium priority alarms: indicates abnormal vital signs or a device malfunction. Medium priority alarms require a prompt response.
Low priority alarms: indicates a discomfort condition, a device malfunction, or an improper operation. Low priority alarms require you to be aware of this condition.
Messages: provides additional information on the patient or the equipment.
Alarm Indicators
When an alarm occurs, the monitor indicates it to you through visual or audible alarm indications. For more information, see the following table.
Alarm Indicator Alarm lamp
High Priority Alarm
Red Flashing frequency: 1.4 2.8 Hz Duty cycle: 20 60% on
Medium Priority Alarm
Low Priority Alarm
Message
Yellow Flashing frequency: 0.4 0.8 Hz Duty cycle: 20 60% on
Cyan No flashing Duty cycle: 100% on
None
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Alarm Indicator
High Priority Alarm
Medium Priority Low Priority Message
Alarm
Alarm
Audible ISO tone pattern
Repeat pattern of triple + double + triple + double beeps
Repeat pattern of triple beeps
Single beep
None
Mode 1
Repeat pattern of high-pitched single beep
Repeat pattern of double beeps
Low-pitched single beep
None
Mode 2
Repeat pattern of high-pitched triple beeps
Repeat pattern of double beeps
Low-pitched single beep
None
Alarm message1
White text inside Black text inside
a red box
a yellow box
Black text inside a cyan box
White text
Alarm priority
***
**
indicator2
*
None
Parameter value
White text inside a flashing red box
Black text inside a flashing yellow box
Black text inside a flashing cyan box
None
1: Alarm messages are displayed in the alarm information area at the top of the screen. You can select the alarm messages to show the alarm list. 2: The indicator shows in front of corresponding alarm message.
NOTE
· When multiple alarms of different priority levels occur simultaneously, the
monitor select the alarm of the highest priority to light the alarm lamp and
issue the alarm tone.
· When multiple alarms of different priority levels occur simultaneously and
should be displayed in the same area, the monitor only displays the
messages of the highest priority alarm.
· When multiple alarms of the same priority levels occur simultaneously alarm
messages are displayed circularly.
· Apnea, and SpO2 Desat are exclusive high priority alarms. When these alarms
occur, the monitor only displays messages of exclusive alarms. Other high
priority alarms will not be displayed. When multiple exclusive alarms occur
simultaneously, alarm messages are displayed circularly.
7 - 3
7.3.4
Alarm Status Symbols
Apart from the alarm indicators as described in 7.3.3 Alarm Indicators, the monitor uses the following symbols to indicate the alarm status:
Alarm pause: indicates that all the alarms are paused.
Alarm off:
indicates that individual measurement alarms are turned off or the system is in the alarm off status.
Audio pause: indicates that audible alarm tones are paused.
Audio off:
indicates that audible alarm tones are turned off.
Alarm reset:
indicates that alarms are acknowledged and the alarm system is reset.
7.4 7.5
7.6
7.6.1
Checking Alarm List
To check the alarm list, follow this procedure:
1. Select the technical alarm area to check the Technical Alarms. 2. Select the physiological alarm area to check the Physiological Alarms.
Accessing On-screen Help for Technical Alarms (AlarmSight)
In the technical alarm list, alarm messages followed by Detail include help messages or pictures to help you identify the problem. This function is called AlarmSight. To access AlarmSight, follow this procedure:
1. Select the technical alarm area to check the Technical Alarms list. 2. From the alarm list select Detail on the right of the desired alarm.
Changing Alarm Settings
From the Alarm column of the main menu select desired buttons to set alarm properties.
Setting Parameter Alarm Properties (Continuous Monitoring Mode)
For workflows under Continuous Monitoring, you can set the alarm properties of physiological alarms of each parameter. Every time you switch to a workflow, the alarm settings of the workflow are loaded. For details, see 3.9.2.4 Changing Alarm Settings.
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You can also change the parameter alarm properties based on the condition of the current patient. To do so, follow this procedure: 1. Select the Main Menu quick key from the Alarm column select Limits. Enter
the password if required.
2. Select a parameter tab and set alarm properties as desired.
You can also change the alarm properties of individual parameter from corresponding parameter menu.
The alarm settings of workflow override the alarm settings under Limits menu and parameter menus. Every time you discharge a patient or switch to another workflow, the workflow settings are loaded.
WARNING
· When monitoring patients that are not continuously attended by a clinical
operator, properly configure the alarm system and adjust alarm settings as per the patient's condition.
7.6.2 Setting Alarm Tone Properties
7.6.2.1
Changing the Alarm Volume
To change the alarm volume, follow this procedure: 1. Select the Main Menu quick key from the Alarm column select Setup.
2. Set Alarm Volume. The optional alarm volume is between X to 10, in which X is the minimum volume, depending on the setting of minimum alarm volume, and 10 is the maximum volume.
3. Select High Alarm Volume to set the volume of the high priority alarm.
4. Select Reminder Volume to set the volume of the reminder tone.
NOTE
· When the alarm volume is set to 0, the alarm sound is turned off and the
audio off symbol appears on the screen.
· You cannot set the volume of high priority alarms if Alarm Volume is set to 0.
7.6.2.2
Setting the Interval between Alarm Sounds
If you choose the ISO pattern, you can change the interval between alarm tones. To change the interval between alarm tones, follow this procedure:
1. Select the Main Menu quick key from the System column select Maintenance input the required password select .
7 - 5
2. Select the Alarm tab Audio tab. 3. Set High Alarm Interval, Med Alarm Interval, and Low Alarm Interval:
Item High Alarm Interval Med Alarm Interval Med Alarm Interval
Range 3 s to 15 s 3 s to 30 s 16 s to 30 s
Default 10 s 20 s 20 s
7.6.2.3
Other Password Protected Audio Alarm Settings
The following alarm settings are password protected: Minimum alarm volume Alarm sound pattern Alarm sound escalation switch and delay For more information, see 18.6.1 The Audio Tab.
7.6.3
Setting the Alarm Delay Time
For continuously measured parameters, you can set the alarm delay time. If the alarm condition is resolved within the delay time, the monitor does not present the alarm.
This setting is password protected. For more information, see 18.6.5 The Other Tab.
The setting of Alarm Delay is not applied to the apnea alarms. You can set Apnea Delay separately.
WARNING
· The alarm delay time can be set to 15 sec at most. Changing this setting to an
inappropriate level may result in a hazard to the patient.
7.6.4 7.6.5
Setting the Apnea Delay Time
To set the apnea delay time, follow this procedure: 1. Select the Main Menu quick key from the Alarm column select Setup. 2. Select Apnea Delay to set the apnea delay time.
Restoring the Default Alarm Settings
To reset all alarm settings to the defaults, follow this procedure: 1. Select the Main Menu quick key from the Alarm column select Setup.
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7.6.6
2. Select the Limits tab. 3. On the Limits page, select Defaults at the bottom.
Setting the CMS and eGateway Disconnection Alarm
You can choose whether to issue an alarm when the monitor is not connected or disconnected from the CMS/eGateway, and set the priority of these alarms. This setting is password protected. For details, see 18.6.5 The Other Tab.
7.6.7
Setting the Switch of the SpO2 Desat Alarm Off
You can choose whether switching off the SpO2 Desat alarm is permissible or not. This setting is password protected. For more information, see 18.6.5 The Other Tab.
WARNING
· If you switch off the SpO2 Desat alarm, the monitor will not alarm when the
patient's SpO2 is extremely low. This may result in a hazard to the patient. Always keep the patient under close surveillance.
7.6.8
Setting the Switch of the Apnea Alarm Off
You can choose whether switching off the apnea alarm is permissible or not. This setting is password protected. For more information, see 18.6.5 The Other Tab.
WARNING
· If you switch off the apnea alarm, the monitor will not issue the apnea alarm
in case that apnea happens. This may result in a hazard to the patient. Keep the patient under close surveillance.
7.7 Pausing Alarms/Pausing Alarm Tones
7.7.1
Defining the Pause Function
You can either pause alarms or pause alarm tones. This depends on the pause setting.This setting is password protected. For more information, see 18.6.2 The Pause/ Reset Tab.
7 - 7
7.7.2
Pausing Alarms
If the pause function is designated as pausing alarms, pressing the Alarm Pause quick key can temporarily disable alarm indicators. When alarms are paused, the following rules are followed:
No physiological alarm will be presented. For technical alarms, alarm sounds are paused, but alarm lamps and alarm
messages remain presented. The remaining alarm pause time is displayed in the physiological alarm
information area. The alarm pause symbol is displayed in the system information area.
When the alarm pause time expires, the alarm paused status is automatically deactivated. You can also cancel the alarm paused status by pressing the Alarm Pause quick key.
The following alarm pause and alarm reset settings are password protected.
Alarm pause time Priorities of paused alarms Alarm reset setting Reminder tone settings
For more information, see 18.6.2 The Pause/Reset Tab.
7.7.2.1
Setting the Alarm Pause Time
The alarm pause time can be set to 1 min, 2 min, 3 min, or Permanent. The default alarm pause time is 2 min.
This function is password protected. For more information, see 18.6.2 The Pause/Reset Tab.
7.7.2.2
Prolonging the Alarm Pause Time
You can temporarily prolong the alarm pause time after the monitor enters the alarm paused status. This function is password protected. For more information, see 18.6.2 The Pause/Reset Tab.
NOTE
· Prolonging alarm pause time does not affect the setting of alarm pause time. · You can not prolong the pause time if the Pause Time is set to Permanent.
7.7.2.3
Selecting the Priority of Paused Alarms
You can select alarms of what priority can be paused. This function is password protected. For more information, see 18.6.2 The Pause/Reset Tab.
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7.7.2.4
Switching Off All Alarms
If Pause Time is set to Permanent (see 18.6.2 The Pause/Reset Tab), pressing the Alarm Pause quick key permanently switches off all alarms. The alarm off status has the following features:
Physiological alarms are switched off. The alarm lamp does not flash and alarm sound is not issued.
Alarm sound of technical alarms is switched off, but alarm lamp flashes and alarm messages are presented.
The message Alarm Off with red background is displayed in the physiological alarm information area.
The alarm off symbol is displayed in the system status information area.
To exit the alarm off status, press the Alarm Pause quick key again.
WARNING
· Pausing or switching off alarms may result in a hazard to the patient.
7.7.3
Pausing Alarm Sound
If the pause function is defined as Audio Pause, pressing the Audio Pause key pauses alarm tone. When alarm tones are paused, the following rules are followed:
The sound of all physiological alarms and technical alarms are switched off.
The remaining audio pause time is displayed in the physiological alarm information area.
The audio pause symbol is displayed in the system information area.
When the audio pause time expires, the audio paused status is automatically deactivated. You can also cancel the audio paused status by pressing the Audio Pause quick key.
7.7.3.1
Setting the Alarm Tone Pause Time
The alarm tone pause time can be set to 1 min, 2 min, 3 min, or Permanent. The default audio pause time is two minutes.
This function is password protected. For more information, see 18.6.2 The Pause/Reset Tab.
7.7.3.2
Prolonging the Alarm Tone Pause Time
You can temporarily prolong the alarm tone pause time after the monitor enters the alarm tone paused status. This function is password protected. For more information, see 18.6.2 The Pause/Reset Tab.
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NOTE
· Prolonging alarm pause time does not affect the setting of alarm tone pause
time.
7.7.3.3
Setting the Priority of Audio Paused Alarms
You can select alarm sound of what priority can be paused. This function is password protected. For more information, see 18.6.2 The Pause/Reset Tab.
7.7.3.4
Switching Off Alarm Sound
If Pause Time is set to Permanent, pressing the Audio Pause quick key permanently switches off all alarm sound. The audio off status has the following features:
Alarm sound of both physiological alarms and technical alarms is switched off. The audio off symbol is displayed in the system information area. The Audio Off message is displayed in the physiological alarm information area
with a red background.
To exit the audio off status, press the Audio Pause quick key again.
WARNING
· Pausing or switching off alarm sound may result in a hazard to the patient.
7.8
Resetting Alarms
Pressing the Alarm Reset quick key to acknowledge the ongoing alarms and reset the alarm system. When the alarm system is reset, the alarm reset symbol displays in the system status information area for alarm symbols.
NOTE
· If a new alarm is triggered after the alarm system is reset, the alarm reset icon
will disappear and the alarm light and alarm tone will be reactivated.
7.8.1
Resetting Physiological Alarms
Physiological alarms give different alarm indicators when the alarm system is reset:
The alarm sound is silenced.
A appears before the alarm message, indicating that the alarm is acknowledged.
The color of the parameter numeric background corresponds with the alarm priority, but the parameter numeric does not flash.
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7.8.2
7.8.3
7.9
Resetting Technical Alarms
Technical alarms give different alarm indicators when the alarm system is reset:
Some technical alarms are cleared. The monitor gives no alarm indications.
Some technical alarms are changed to the prompt messages.
For some technical alarms, the alarm is silenced and a appears before the alarm message, indicating that the alarm is acknowledged.
For details about the indications of technical alarms when the alarm system is reset, see D Alarm Messages.
Setting Alarm Light Status on Alarm Reset
When the alarm system is reset, the monitor presents the alarm light by default, but you can switch off the alarm light. This function is password protected. For more information, see 18.6.2 The Pause/Reset Tab.
Latching Alarms
The latching setting for physiological alarms defines how alarm indicators behave if you do not reset the alarms.
If you do not "latch" physiological alarms, their alarm indications disappear when the alarm condition ends.
If you "latch" physiological alarms, all visual and audible alarm indications remains until you reset the alarms. For latched alarms the time when the alarm is last triggered is displayed behind the alarm message.
You can separately latch visual indications or simultaneously latch the visual and the audible indications.
When visual indications are latched, visual indications, including alarm lamp, alarm message and its background remains when the alarm condition ends and the time when the alarm last triggered is displayed behind the alarm message.
When audible indications are latched, the monitor issues alarm sounds when the alarm condition ends.
The alarm latch settings is password protected.
NOTE
· Changing alarm priority may affect the latching status of corresponding
alarm. Determine if you need to reset the alarm latching status if you changed the alarm priority.
· When the alarm system is reset, latched physiological alarms are cleared.
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7.10
Nurse Call
The monitor provides a nurse call connector to output nurse call signal when a userdefined alarm occurs. To obtain nurse call signal, use the nurse call cable to connect the hospital nurse call system with the monitor's nurse call connector.
Alarms are indicated on the nurse call device only when the following conditions are met:
The nurse call system is enabled. A user-defined alarm occurs. Alarms are not paused or reset.
This function is password protected. For more information, see 18.6.4 The Nurse Call Tab.
WARNING
· Do not rely exclusively on the nurse call system for alarm notification.
Remember that the most reliable alarm notification combines audible and visual alarm indications with the patient's clinical condition.
7.11 7.12
Testing Alarms
The monitor automatically performs a selftest at startup. Check that an alarm tone is heard, and the alarm lamp illuminates, one after the other, in red, yellow, and cyan. This indicates that the visible and alarm indicators function correctly.
To further test individual measurement alarms, perform measurement on yourself or using a simulator. Adjust alarm limits and check that appropriate alarm behavior is observed.
Actions When an Alarm Occurs
When an alarm occurs, observe the following steps and take proper actions:
1. Check the patient's condition. 2. Confirm the alarming parameter or alarm category. 3. Identify the source of the alarm. 4. Take proper action to eliminate the alarm condition. 5. Make sure the alarm condition is corrected. For more information, see D Alarm Messages.
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8 Monitoring Pulse Oxygen Saturation
(SpO2)
8.1
SpO2 Introduction
Pulse Oxygen Saturation (SpO2) monitoring is a non-invasive technique used to measure the amount of oxygenated haemoglobin and pulse rate by measuring the absorption of selected wavelengths of light. The light generated in the emitter side of the probe is partly absorbed when it passes through the monitored tissue. The amount of transmitted light is detected in the detector side of the probe. When the pulsative part of the light signal is examined, the amount of light absorbed by the haemoglobin is measured and the pulse oxygen saturation can be calculated. This device is calibrated to display functional oxygen saturation.
SpO2 monitoring is intended for adult, pediatric and neonatal patients.
The following types of SpO2 can be configured for the monitor:
Mindray SpO2: the connector is blue and no logo is on the monitor.
Nellcor SpO2: the connector is grey and the logo of Nellcor is on the monitor.
Masimo SpO2: the connector is purple and the logo of Masimo SET is on the monitor.
NOTE
· The SpO2 extension cable should be compatible with the SpO2 connectors.
For example, you can only connect the Mindray SpO2 extension cable to the Mindray SpO2 connectors.
· A functional tester or SpO2 simulator can be used to determine the pulse rate
accuracy.
· A functional tester or SpO2 simulator cannot be used to assess the SpO2
accuracy.
8 - 1
8.2
SpO2 Safety Information
WARNING
· When a trend toward patient deoxygenation is indicated, analyze the blood
samples with a laboratory co-oximeter to completely understand the
patient's condition.
· Do not use SpO2 sensors during magnetic resonance imaging (MRI). Induced
current could potentially causes burns. The sensor may affect the MRI image,
and the MRI unit may affect the accuracy of the oximetry measurements.
· Prolonged continuous monitoring may increase the risk of undesirable
changes in skin characteristics, such as irritation, reddening, blistering or
burns. Inspect the sensor site every two hours and move the sensor if the skin
quality changes. Change the application site every four hours. For neonates,
or patients with poor peripheral blood circulation or sensitive skin, inspect
the sensor site more frequently.
· If the sensor is too tight because the application site is too large or becomes
too large due to edema, excessive pressure for prolonged periods may result
in venous congestion distal from the application site, leading to interstitial
edema and tissue ischemia.
· When patients are undergoing photodynamic therapy they may be sensitive
to light sources. Pulse oximetry may be used only under careful clinical
supervision for short time periods to minimize interference with
photodynamic therapy.
· Setting alarm limits to extreme values may cause the alarm system to
become ineffective. For example, high oxygen levels may predispose a
premature infant to retrolental fibroplasia. If this is a consideration, do not
set the high alarm limit to 100%, which is equivalent to switching off the
alarm.
· SpO2 is empirically calibrated in healthy adult volunteers with normal levels
of carboxyhemoglobin (COHb) and methemoglobin (MetHb).
· To protect from electric shock, always remove the sensor before bathing the
patient.
· The pulse oximetry function of the bedside monitor should not be used for
apnea monitoring.
· The pulse oximetry function of the bedside monitor should not be used for
arrhythmia analysis.
8 - 2
8.3
CAUTION
· Change the application site or replace the sensor and/or patient cable when a
persistent SpO2 Low Signal Quality message is displayed on the equipment. These messages may indicate that patient monitoring time is exhausted on the patient cable or sensor.
· Replace the cable or sensor when a "SpO2 Sensor Off", "SpO2 No Sensor", or
"SpO2 Low Signal Quality" message is consistently displayed while monitoring consecutive patients after completing troubleshooting steps listed in this manual.
· Variation in measurements may be profound and may be affected by
sampling technique as well as the patient's physiological conditions. Any results exhibiting inconsistency with the patient's clinical status should be repeated and/or supplemented with additional test data. Blood samples should be analyzed by laboratory instruments prior to clinical decision making to completely understand the patient's condition.
· Use only SpO2 sensors specified in this manual. Follow the SpO2 sensor's
instructions for use and adhere to all warnings and cautions.
· Do not place the pulse oximeter where the controls can be changed by the
patient.
· If using patient monitor during full body irradiation, keep the sensor out of
the radiation field. If the sensor is exposed to the radiation, the reading might be inaccurate or the device might read zero for the duration of the active irradiation period.
NOTE
· Additional information specific to the Masimo sensors compatible with the
equipment, including information about parameter/measurement performance during motion and low perfusion, may be found in the sensor's directions for use (DFU).
· Masimo cables and sensors are provided with X-CalTM technology to minimize
the risk of inaccurate readings and unanticipated loss of patient monitoring. Refer to the Cable or Sensor DFU for the specified duration of the patient monitoring time.
SpO2 Measurement Limitations
The following factors may influence the accuracy of SpO2 measurement:
Patient physiological characteristics:
Cardiac arrest
8 - 3
Hypotension Darkly pigmented skin Shock Severe vasoconstriction Hypothermia Severe anemia Ventricular septal defects (VSDs) Venous pulsations Poor perfusion Dysfunctional hemoglobin, such as carboxyhemoglobin (COHb) and
methemoglobin (MetHb) Elevated levels of bilirubin Vasospastic disease, such as Raynaud's, and peripheral vascular disease Hemoglobinopathies and synthesis disorders such as thalassemias, Hb s, Hb
c, sickle cell, etc. Hypocapnic or hypercapnic conditions Birthmark(s), tattoos, skin discolorations, moisture on skin, deformed or
abnormal fingers. etc. Interfering substances:
Intravascular dyes (such as indocyanine green, methylene blue, indigo carmine, etc.)
Dyes in the measure site, such as nail polish. Environmental conditions:
Excessive ambient light Electrosurgery equipment Defibrillation (may cause inaccurate reading for a short amount of time) Excessive patient/sensor motion Electromagnetic field Arterial catheters and intra-aortic balloon Others Inappropriate positioning of the SpO2 sensor, or use of incorrect SpO2
sensor Cuff or arterial blood pressure measurement device on the same limb as the
SpO2 sensor.
8 - 4
8.4 SpO2 Display
1
2 3
4 5
1
Oxygen saturation of arterial blood (SpO2): percentage of oxygenated hemoglobin
in relation to the sum of oxyhemoglobin and deoxyhemoglobin.
2 Perfusion indicator: the pulsatile portion of the measured signal caused by arterial pulsation.
3 Perfusion index (PI): gives the numerical value for the pulsatile portion of the measured signal caused by arterial pulsation. PI is an indicator of the pulsatile strength. You can also use it to assess the SpO2 signal strength. · Above 1 is optimal.
· Between 0.3 and 1 is acceptable. The PI is displayed with a yellow background.
· Below 0.3 indicates low perfusion. The PI is displayed with a red background and the SpO2 value is outlined. Reposition the SpO2 sensor or find a better site. If low perfusion persists, choose another method to measure oxygen saturation if possible.
4 Pulse rate (derived from the pleth wave): detected pulsations per minute.
5 Pleth waveform (Pleth): visual indication of patient's pulse. The waveform is not normalized.
NOTE
· PI is only available for Mindray SpO2 and Masimo SpO2. · If the measurement fails, or measurement is not taken, "--" is displayed. · Outlined numerics indicate that the measurement may not be reliable. So
these values are not recommended for reference.
8.5 Preparing for SpO2 Monitoring
To prepare to monitor SpO2, follow this procedure:
8 - 5
1. Select an appropriate sensor according to the module type, patient category, weight, and measurement site.
2. Clean the contact surface of the reusable sensor.
3. Remove colored nail polish, earrings, or other extraneous matter from the application site.
4. Apply the sensor to the patient according to the instruction for use of the sensor.
5. Select an appropriate extension cable according to the connector type and plug the cable into the SpO2 connector.
6. Connect the sensor to the extension cable.
CAUTION
· Do not apply sensor too tightly as this results in venous pulsation which may
severely obstruct circulation and lead to inaccurate measurements.
· At elevated ambient temperatures be careful with measurement sites that
are not well perfused, because this can cause burns after prolonged application.
· Avoid placing the sensor on extremities with an arterial catheter, an NBP cuff
or an intravascular venous infusion line.
· For neonatal patients, make sure that all sensor connectors and adapter
cable connectors are outside the incubator. The humid atmosphere inside can cause inaccurate measurements.
8.6 Changing the SpO2 Settings
NOTE
· Alarm related settings are available only when the monitoring is in
Continuous Monitoring mode.
8.6.1
Changing the SpO2 Alarm Settings
In Continuous Monitoring mode, you can change the SpO2 alarm settings. Follow this procedure:
1. Select the SpO2 numeric area or waveform area to enter the SpO2 menu. 2. Select the Alarm tab. 3. Enter the password if required. 4. Set the alarm properties of SpO2 and SpO2 Desat.
8 - 6
NOTE
· The desat alarm is a high level alarm notifying you of potentially life
threatening drops in oxygen saturation. When the SpO2 value is below the
desat alarm limit and desat alarm switch is set on, the message "SpO2 Desat"
is displayed.
· You can switch off the SpO2 Desat alarm only when SpO2 Desat Alarm Off is
enabled. For more information, see section 7.6.7 Setting the Switch of the
SpO2 Desat Alarm Off.
8.6.2
Nellcor Sat-SecondsTM Alarm Management
With traditional alarm management, high and low alarm limits are set for monitoring oxygen saturation. During monitoring, once an alarm limit is violated, an audible alarm immediately sounds. When the patient SpO2 fluctuates near an alarm limit, the alarm sounds each time the limit is violated. Such frequent alarms can be distracting. Nellcor's Sat-Seconds alarm management technique is used to reduce these nuisance alarms.
The Sat-Seconds feature is available with the Nellcor SpO2 to decrease the likelihood of false alarms caused by motion artifacts. With Sat-Seconds alarm management, high and low alarm limits are set in the same way as those with traditional alarm management. A Sat-Seconds limit is also set. The Sat-Seconds limit controls the amount of time that SpO2 saturation may be outside the set limits before an alarm sounds.
The method of calculation is as follows: the percentage points of the SpO2 saturation falling outside the alarm limit is multiplied by the number of seconds remaining outside the limit. This can be stated as the equation:
Sat-Seconds = Points × Seconds
Only when the Sat-Seconds limit is reached, the monitor gives a Sat-Seconds alarm. For example, the figure below demonstrates the alarm response time with a Sat-Seconds limit set at 50 and a low SpO2 limit set at 90%. In this example, the patient SpO2 drops to 88% (2 points) and remains there for 2 seconds. Then it drops to 86% (4 points) for 3 seconds, and then to 84% (6 points) for 6 seconds. The resulting Sat-Seconds are:
% SpO2 2× 4× 6× Total Sat-Seconds=
Seconds 2= 3= 6=
Sat-Seconds 4 12 36 52
8 - 7
After approximately 10.9 seconds, a Sat-Second alarm would sound, because the limit of 50 Sat-Seconds would have been exceeded.
%SpO2
Seconds
Saturation levels may fluctuate rather than remaining steady for a period of several seconds. Often, the patient SpO2 may fluctuate above and below an alarm limit, reentering the non-alarm range several times. During such fluctuation, the monitor integrates the number of SpO2 points, both positive and negative, until either the SatSeconds limit is reached, or the patient SpO2 re-enters the non-alarm range and remains there.
NOTE
· The SpO2 Too Low or SpO2 Too High alarm is presented in the case that SpO2
value violates the alarm limits for 3 times within one minute even if the setting of Sat-Seconds is not reached.
8.6.3
Setting the Nellcor SpO2 Sat-Seconds
In Continuous Monitoring mode, you can set the Sat-Seconds. Follow this procedure:
1. Select the SpO2 numeric area or waveform area to enter the SpO2 menu. 2. Select the Alarm tab. 3. Set Sat-Seconds.
8 - 8
8.6.4
Setting SpO2 Sensitivity (for Masimo SpO2)
For Masimo SpO2, selects the Sensitivity as per signal quality and patient motion.
Normal sensitivity is the recommended for patients who are experiencing some compromise in blood flow or perfusion. It is advisable for care areas where patients are observed frequently, such as the intensive care unit (ICU).
Adaptive Probe Off Detection (APOD) sensitivity is the recommended sensitivity mode where there is a high probability of the sensor becoming detached. It is also the suggested mode for care areas where patients are not visually monitored continuously. This mode delivers enhanced protection against erroneous pulse rate and arterial oxygen saturation readings when a sensor becomes inadvertently detached from a patient due to excessive movement.
Maximum sensitivity is recommended for use on patients with weak signals (e.g. high ambient noise and/or patients with very low perfusion) and for use during procedures or when clinician and patient contact is continuous such as in higher acuity settings.
To set SpO2 sensitivity, follow this procedure:
1. In Continuous Monitoring mode, select the SpO2 numeric area or waveform area to enter the SpO2 menu. In Spot Check mode, select the Main Menu quick key from the Parameters column select Setup select SpO2.
2. Select the Setup tab.
3. Set Sensitivity to Maximum, Normal, or APOD.
CAUTION
· When using the Maximum Sensitivity setting, performance of "Sensor Off"
detection may be compromised. If the equipment and the sensor becomes detached from the patient, the potential for false readings may occur due to environmental noise such as light, and vibration.
· Changing workflows may result in Masimo SpO2 being set to Maximum
sensitivity mode on power up or after admitting a new patient. Maximum sensitivity is recommended for use during procedures or when clinician and patient contact is continuous, such as in higher acuity settings. Maximum sensitivity is not recommended for care areas where patients are not monitored visually as "Sensor Off" detection may be compromised.
8.6.5
Enabling FastSAT (for Masimo SpO2)
FastSAT enables rapid tracking of arterial oxygen saturation changes as may be required in urgent situations. When FastSAT is switched on, the averaging algorithm evaluates all the SpO2 values and provides an averaged SpO2 value that is a better representation of the patient's current oxygen saturation status.
8 - 9
8.6.6
The reliability of FastSAT is dependent on the setting for the averaging time and the input signal. FastSAT is disabled by default. To enable FastSAT, follow this procedure:
1. In Continuous Monitoring mode, select the SpO2 numeric area or waveform area to enter the SpO2 menu. In Spot Check mode, select the Main Menu quick key from the Parameters column select Setup select SpO2.
2. Select the Setup tab.
3. Switch on Fast SAT.
Displaying SIQ (for Masimo SpO2)
The signal quality indicator (SIQ) displays below the Pleth waveform. The SIQ is conveyed by vertical bars. The height of the bar provides an assessment of the confidence in the displayed SpO2 value. The SpO2 SIQ can also be used to identify the occurrence of a patient `s pulse.
The following picture shows the SpO2 SIQ:
1
8.6.7
1. Signal quality indicator (SIQ) To show SpO2 SIQ, follow this procedure:
1. In Continuous Monitoring mode, select the SpO2 numeric area or waveform area to enter the SpO2 menu. In Spot Check mode, select the Main Menu quick key from the Parameters column select Setup select SpO2.
2. Select the Setuptab.
3. Switch on Display SIQ.
Changing Averaging Time (for Masimo SpO2)
The SpO2 value displayed on the monitor screen is the average of data collected within a specific time. The shorter the averaging time is, the quicker the monitor responds to changes in the patient's oxygen saturation level. Contrarily, the longer the averaging time is, the slower the monitor responds to changes in the patient's oxygen saturation level, but the SpO2 measurement is more stable. For critically ill patients, selecting a shorter averaging time will help with understanding the patient's state.
To set the averaging time, follow this procedure:
1. In Continuous Monitoring mode, select the SpO2 numeric area or waveform area to enter the SpO2 menu. In Spot Check mode, select the Main Menu quick key from the Parameters column select Setup select SpO2.
2. Select the Setup tab.
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8.6.8 8.6.9
3. Set Averaging.
Changing the Sensitivity (for Mindray SpO2)
The SpO2 value displayed on the monitor screen is the average of data collected within a specific time. The shorter the averaging time is, the quicker the monitor responds to changes in the patient's oxygen saturation level. Contrarily, the longer the averaging time is, the slower the monitor responds to changes in the patient's oxygen saturation level, but the SpO2 measurement is more stable. For critically ill patients, selecting shorter averaging time will help understanding the patient's state.
To set the averaging time, follow this procedure:
1. In Continuous Monitoring mode, select the SpO2 numeric area or waveform area to enter the SpO2 menu. In Spot Check mode, select the Main Menu quick key from the Parameters column select Setup select SpO2.
2. Select the Setup tab.
3. Set the Sensitivity.
Showing/Hiding PI
You can set whether to display PI in the SpO2 parameter area. To do so, follow this procedure:
1. In Continuous Monitoring mode, select the SpO2 numeric area or waveform area to enter the SpO2 menu. In Spot Check mode, select the Main Menu quick key from the Parameters column select Setup select SpO2.
2. Select the Setup tab.
3. Switch on or off Display PI.
NOTE
· This function is only available for Mindray SpO2 and Masimo SpO2.
8.6.10
Monitoring SpO2 and NIBP Simultaneously
When monitoring SpO2 and NIBP on the same limb simultaneously, you can switch on NIBP Simul to lock the SpO2 alarm status until the NIBP measurement ends. If you switch off NIBP Simul, low perfusion caused by NIBP measurement may lead to inaccurate SpO2 readings and therefore cause false physiological alarms.
In Continuous Monitoring mode, you can set the NIBP Simul. Follow this procedure:
1. Select the SpO2 numeric area or waveform area to enter the SpO2 menu. 2. Select the Alarm tab.
3. Set NIBP Simul.
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8.6.11
Changing the Sweep Speed of the Pleth Wave
To set the sweep speed of Pleth waveforms, follow this procedure:
1. In Continuous Monitoring mode, select the SpO2 numeric area or waveform area to enter the SpO2 menu. In Spot Check mode, select the Main Menu quick key from the Parameters column select Setup select SpO2.
2. Select the Setup tab.
3. Set Speed.
8.6.12
Setting the Alarm Priority for SpO2 Sensor Off Alarm
The level for SpO2 Sensor Off alarm under Continuous Monitoring mode can be set. Follow this procedure:
1. Select the Main Menu quick key from the System column select Maintenance input the required password select .
2. Select the Alarm tab select the Other tab.
3. Set SpO2 Sensor Off.
8.6.13
Setting the SpO2 Tone Mode
The monitor adjusts the QRS tone (pitch tone) according to the SpO2 values. To set the SpO2 tone mode, follow this procedure:
1. Select the Main Menu quick key from the System column select Maintenance input the required password select .
2. Select the Other tab.
3. Set SpO2 Tone.
CAUTION
· The same SpO2 tone mode shall be used for the same monitors in a single
area.
8.7
SpO2 Troubleshooting
This section lists the problems that might occur. If you encounter the problems when using the equipment or accessories, check the table below before requesting for services. If the problem persists, contact your service personnel.
NOTE
· For the physiological and technical alarm messages, see D Alarm Messages.
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8.8
Problem
Solution
Do not see SpO2 numeric area or waveform area on the main screen
Check that the SpO2 is set to display in the Edit Workflow menu. For more information, see 3.9.2.2 Setting the Screen Layout.
Dashes "- -" display in place of numerics.
1. Check that the cable connections of SpO2 sensor and the extension cable are tight. Replace the SpO2 sensor or the extension cable if needed. 2. Reconnect the SpO2 sensor if the alarm SpO2 Sensor Off appears. 3. Check the PI value. If the PI value is too low, adjust the SpO2 sensor, or apply the sensor to the site with better perfusion. 4. Move the sensor to the place with weaker light, or cover the
sensor with shade cloth if the alarm SpO2 Sensor Off appears.
Low amplitude SpO2 signal
SpO2 value is inaccurate
1. The SpO2 sensor and NIBP cuff are placed on the same limb. Change a monitoring site if necessary. 2. Check the PI value. If the PI value is too low. Adjust the SpO2 sensor, or apply the sensor to the site with better perfusion. 3. Check the sensor and its application site.
1. Check the patient's vital signs. 2. Check for conditions that may cause inaccurate SpO2 readings. For more information, see 8.3 SpO2 Measurement Limitations. 3. Check the monitor, the SpO2 sensor for proper functioning.
Nellcor Information
Nellcor Patents
This device may be covered by one or more of the following US patents and foreign equivalents: 5,485,847, 5,676,141, 5,743,263, 6,035,223, 6,226,539, 6,411,833, 6,463,310, 6,591,123, 6,708,049, 7,016,715, 7,039,538, 7,120,479, 7,120,480, 7,142,142, 7,162,288, 7,190,985, 7,194,293, 7,209,774, 7,212,847, 7,400,919.
No Implied License
Possession or purchase of this device does not convey any express or implied license to use the device with unauthorized replacement parts which would, alone, or in combination with this device, fall within the scope of one or more of the patents relating to this device.
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8.9 Masimo Information
Masimo Patents
This posting serves as notice under 35 U.S.C.§287(a) for Masimo patents: http:// www.masimo.com/patents.htm.
No Implied License
Possession or purchase of this device does not convey any express or implied license to use the device with unauthorized sensors or cables which would, alone, or in combination with this device, fall within the scope of one or more of the patents relating to this device.
Masimo End-User License Agreement
THIS DOCUMENT IS A LEGAL AGREEMENT BETWEEN YOU ("PURCHASER") AND SHENZHEN MINDRAY. IF YOU DO NOT AGREE TO THE TERMS OF THIS AGREEMENT, PROMPTLY RETURN THE ENTIRE PACKAGE, INCLUDING ALL ACCESSORIES, IN THEIR ORIGINAL PACKAGE, WITH YOUR SALES RECEIPT TO SHENZHEN MINDRAY FOR A FULL REFUND.
1. Grant of License. In consideration of payment of the license fee, which is part of the price paid for this product, Shenzhen Mindray grants to Purchaser a nonexclusive, nontransferable license, without right to sublicense, to use the copy of the incorporated software/firmware, and documentation in connection with Purchaser's use of the Masimo Products for their labeled purpose. Shenzhen Mindray reserves all rights not expressly granted to Purchaser.
2. Ownership of Software/Firmware. Title to, ownership of, and all rights and interests in, any Masimo software and/or firmware and the documentation, and all copies thereof, remain at all times vested in Masimo Corporation, licensor to Shenzhen Mindray, and they do not pass to Purchaser.
3. Assignment. Purchaser shall not assign or transfer this License, in whole or in part, by operation of law or otherwise, without Shenzhen Mindray's prior written consent; any attempt without such consent, to assign any rights, duties or obligations arising hereunder shall be void.
4. Copy Restrictions. The software/firmware, mask works, circuit board layouts, and accompanying written materials are copyrighted. Unauthorized copying of the software, including software that has been modified, merged, or included with other software, or other written materials is expressly forbidden. You may be held legally responsible for any copyright infringement that is cause or incurred by your failure to abide by the terms of this license. Nothing in this license provides any rights beyond those provided by 17 U.S.C. §117.
8 - 14
5. Use Restriction. As the Purchaser, you may physically transfer the products from one location to another provided that the software/firmware is not copied. You may not electronically transfer the software/firmware from the products to any other device. You may not disclose, publish, translate, release distribute copies of, modify, adapt, translate, reverse engineer, decompile, disassemble, or create derivative works based on the Masimo Product, the software/firmware, or the written materials without the prior written consent of Masimo. Masimo Sensors that are designated for single use are licensed under Masimo patents for use on a single patient only, and are not sold. There is no license, implied or otherwise, that would allow use of single use Masimo Sensors beyond their intended single use. After use of single use Masimo Sensors, there is no further license granted by Masimo to use the sensors and they must be discarded.
6. Transfer Restrictions. The software/firmware is licensed to the Purchaser, and may not be transferred to anyone, except other end-users, without the prior written consent of Shenzhen Mindray. In no event may you transfer, assign, rent, lease, sell, or otherwise dispose of the software/firmware or the products on a temporary basis.
7. Beneficiary. Masimo Corporation is a Beneficiary of this Agreement and has the right to enforce its provisions.
U.S. Government Rights: If you are acquiring software (including the related documentation) on behalf of any part of the United States Government, the following provisions apply: the software is deemed to be "commercial software" and "commercial computer software documentation," respectively pursuant to DFAR Section 227.7202 FAR 12.212, as applicable. Any use, modification, reproduction, release, performance, display or disclosure of the software (including the related documentation) by the U.S. Government or any of its agencies shall be governed solely by the terms of this Agreement and shall be prohibited except to the extent expressly permitted by the terms of this agreement.
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9 Monitoring PR
9.1 9.2
PR Introduction
The pulse numeric counts the arterial pulsations that result from the mechanical activity of the heart.The pulse value can be from SpO2 or NIBP. The PR parameter area displays its source.
PR Display
6 1
5 2 3
4
1. PR unit
2. PR high limit 3. PR low limit
4. PR Source: it can be sourced from SpO2 or NIBP, with SpO2 taking precedence. 5. Pulse rate (PR): detected pulsations per minute. 6. In Spot Check mode, select this area to mark the pulse as regular or irregular. It
can be switched on or off. For details, see 9.3.3 Enabling Irregular PR.
NOTE
· A functional tester or SpO2 simulator can be used to determine the pulse rate
accuracy.
9.3 Changing the PR Settings
9.3.1
Changing the PR Alarm Settings
In Continuous Monitoring mode, you can change the PR alarm settings. Follow this procedure:
1. Select the PR numeric area to enter the PR menu.
9 - 1
9.3.2 9.3.3
2. Select the PR Alarm tab. 3. Set the alarm properties of PR.
Changing the Pulse Volume
To change the pulse volume, follow this procedure:
1. In Continuous Monitoring mode, select the PR numeric area to enter the PR menu. In Spot Check mode, select the Main Menu quick key from the Parameters column select Setup select PR.
2. Select PR Setup tab.
3. Set the Pulse Volume to an appropriate level.
Enabling Irregular PR
To enable the Irregular PR function, follow this procedure:
1. Select the Main Menu quick key from the Configuration column select Workflow input the required password select .
2. Select
on the right of the workflow to be set. Make sure the workflow is
under Spot Check.
3. Select Parameters Setup PR.
4. Switch on Irr. PR Switch.
9 - 2
10Measuring Temperature (Temp)
10.1
Temp Introduction
The monitor can measure temperature with any one of the following temperature modules: Mindray SmarTempTM module Convidien GeniusTM 3 tethered tympanic thermometer Exergen TemporalScannerTM thermometer HeTaida Thermometer Below is a view of monitors configured with the above modules:
SmarTempTM
GeniusTM 3, TemporalScannerTM and HeTaida Thermometer
1
2
2
10.2
1. Probe well 2. Connector for thermometers or Temp sensors
Temp Display
6
1 2 3 1. Temp unit
5 4
10 - 1
10.3
2. Measurement site: displays the current measurement site. You can select this area to select another measurement site.
3. Alarm off symbol if Temp alarm is off; alarm limit if Temp alarm is on
4. Select this area to manually input a measured Temp value 5. Temp reading
6. Measurement mode (for SmarTemp only): displays the current mode, where "P" stands for Predictive and "M" stands for "Monitor". You can select this area to switch to another mode.
Monitoring Temp with SmarTempTM Module
The SmarTempTM Temp module is intended for monitoring oral, axillary and rectal temperature of adult and pediatric patients and axillary temperature of neonatal patients.
Temperature can be measured in either Predictive mode or Monitor mode. The default is Predictive mode.
WARNING
· Do not take oral temperature on the infant (0-3 years). · Do not take rectal temperature on the neonate (0-28 days). · Use only the specified temperature probe and probe cover. Using other
probe or probe cover, or not using probe cover may cause damage to the
monitor or failure to meet the declared specifications in this manual.
· The temperature probe cover is disposable. Re-use of probe cover may result
in patient cross-contamination.
· Use disposable probe covers for temperature measurement. Failure to use a
probe cover can cause inaccurate temperature readings, and patient cross-
contamination.
· Check the disposable probe cover for damage before using. Never use any
probe cover for temperature measurement in case of damage or
contamination.
· Be careful to avoid damaging the temperature probe. Place the temperature
probe in the probe well if not in use.
· Prior to taking a temperature, instruct the patient not to bite down on the
probe, as patient injury and damage to the probe may result.
· In the rectal mode, incorrect probe placement may result in bowel
perforation.
· Wash hands after temperature is taken. This will significantly reduce the risk
of cross contamination and nosocomial contamination.
10 - 2
· Ensure that probe covers are disposed of according to local regulations or
hospital's requirements.
· Accuracy verification of the temperature module is required every two years
or according to your hospital's policy. Please contact our Customer Service if accuracy verification is needed.
NOTE
· Patient actions may interfere with oral temperature readings. Ingesting hot
or cold liquids, eating food, chewing gum, brushing teeth, smoking, or performing strenuous activities may affect temperature readings for up to 20 minutes after the activity has ended.
· In the axillary mode, the probe shall directly contact with patient's skin.
Measuring through patient's clothes or long-term exposure of patient's armpit to the air may result in inaccurate temperature reading.
· Choose appropriate probe according to patient type and measurement site.
Using the incorrect probe may cause patient's discomfort and inaccurate measurements.
· Improper use of probe may also cause patient's discomfort and inaccurate
measurements.
10.3.1 Measuring Temp
10.3.1.1 Selecting Measuring Site
The temperature module can be configured with 2 types of temperature probe:
Type
Color
Patient Category
Measurement Site
Oral/axillary
Red
Rectal
Blue
Adult, pediatric Neonate Adult, pediatric
Oral, axillary Axillary Rectal
The blue oral/axillary probe shall only be used with blue probe well, while the red rectal probe shall only be used with red well.
Be sure to select correct probe according to the measurement site.
For adult and pediatric patients, when oral/axillary probe is used, the measurement site will automatically be set to Oral. You can change the site in Temp area.
For neonatal patients, when oral/axillary probe is used, the measurement site will automatically be set to Axillary. The measurement site cannot be changed.
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10.3.1.2 Taking a Temperature in Predictive Mode
1. Verify that the probe is placed in the probe well.
2. Verify that the temperature measurement type and site are correct.
3. Unplug the probe from the probe well and the measurement mode changes to Predictive automatically.
4. Insert it into a cover in the probe cover pack and press the probe handle down firmly until the cover engages with the probe.
The temperature module starts to warm up when the probe is taken out. The message "Temp Warming Up" displays in Temp parameter area. The warming up time is about 2 seconds in room temperature. The monitor issues two beeps and provides the message "Temp Prediction Ready" on the screen when warm-up is complete. Then you can place the probe at measurement site.
5. Place the probe at measurement site and wait till the measurement stabilizes. When the dynamic symbol appears, it indicates that the monitor starts to take the measurement.
When taking an oral temperature, apply the probe under the patient's
tongue from either side of the mouth. Verify that the probe reaches the rear sublingual pocket. Have the patient close his/her lips to hold the probe. Hold the probe in place. Make sure that the probe contacts with the patient's oral tissue throughout the measurement.
When taking an axillary temperature, lift the patient's arm to expose the
entire armpit. Apply the probe as high as possible in the armpit. Check that the probe tip is completely surrounded by the axillary tissue. Lower the patient's arm so that it is tightly placed at the patient side. Keep the patient's arm and the probe in place throughout the measurement.
When taking a rectal temperature, separate patient's buttocks with one
hand, and the probe 1.5 cm inside the rectum with the other hand. For pediatric patient, depth of insertion shall be less. Tilt the probe so that it always contacts with patient's tissue. Lubricant can be used in rectal mode.
The monitor will give a beep as the temperature measurement is complete. The temperature reading displays continuously until the probe is taken out from the probe well.
6. Withdraw the probe. Press firmly the ejection button on the top of the probe to eject the probe cover. Replace the probe into the probe well.
In Predictive mode, the monitor automatically enters Monitor mode in the following cases:
Accurate temperature is not reached.
Neither measurement is taken nor is the probe replaced in the probe well in 60 seconds after the probe is withdrawn from the well.
The temperature type automatically changes to Predictive mode when the probe returns to the probe well.
10 - 4
NOTE
· In Predictive mode, temperature probe shall be placed to the measurement
site as soon as probe warmup is complete; otherwise, inaccurate temperature
reading may result.
· In Predictive mode, if the probe has a high temperature due to the
environmental temperature or other causes, cool the probe and then
measure the patient's temperature.
10.3.1.3 Taking a Temperature in Monitor Mode
To measure a temperature in the Monitor mode,
1. Verify that the probe is placed in the probe well.
2. Verify that the temperature measurement type and site are correct.
3. Select P/M on the screen to set the measurement mode to Monitor. 4. Unplug the probe from the probe well and insert it into a cover in the probe cover
pack. Press the probe handle down firmly until the cover engages with the probe.
5. Place the probe to the measurement site and then start measuring. Refer to Step 4 in 10.3.1.2 Taking a Temperature in Predictive Mode for how to place a probe.
6. Withdraw the probe. Press firmly the ejection button on the top of the probe to eject the probe cover. Replace the probe into the probe well.
NOTE
· In Monitor mode, record the measured value prior to taking away the probe
from measurement site. The monitor will automatically stop measuring temperature after 10 minutes from the start of the measurement.
10.3.2
Disinfecting Temperature Probe
The recommended disinfectants include: ethanol 70%, isopropanol 70%, glutaraldehyde-type 2% liquid disinfectants.
To disinfect the temperature probe:
1. Disconnect the temperature probe from Temp connector.
2. Disinfect the probe with a soft cloth dampened with the recommended disinfectant.
3. Wipe off all the remaining disinfectants from the probe with a soft cloth dampen with water.
4. Dry the probe in a cool place.
10 - 5
WARNING
· Perform the decontamination or cleaning process with the monitor powered
down and power cord removed.
· The used soft cloth shall be properly disposed of.
10.4
Monitoring Temp with GeniusTM 3 Tethered Tympanic Thermometer
The GeniusTM 3 tethered tympanic thermometer is a fast, accurate, and convenient clinical instrument for measuring patient temperatures. The GeniusTM 3 thermometer is an ear canal thermometer with measurement site equivalence modes including oral and rectal equivalent temperatures.
The thermometer is powered by the monitor.
Refer to the Genius 3 Tethered Tympanic Thermometer Operator's Manual for additional information.
10.4.1 Safety Information
WARNING
· No alarm is provided for the temperature measurement.
CAUTION
· Used probe covers must be treated as infectious biological waste and
disposed of in accordance with current medical practices and local regulations.
10.4.2 Thermometer Buttons
Button
Name Eject button
Functions Press the eject button to eject the probe cover from the probe.
10 - 6
°C/°F button
When a temperature is in the display, you may press and hold the °C/°F button to toggle between degrees Celsius and degrees Fahrenheit.
Timer button Press and hold the timer button to enter the timer mode. Press again to start the timer.
Scan button
When the thermometer is on, press the scan button to initiate a temperature measurement.
When the thermometer is off, press the scan button to turn on the device.
10.4.3
Equivalence Mode Temperature
The thermometer can measure the ear temperature and acquire the equivalence temperature.
A patient's temperature at the site of mouth or rectum would be slightly different from the ear temperature. The thermometer compensates for the average difference in temperature at each of these sites by adjusting the displayed temperature.
A checker/calibrator is available for this device. The device should be checked if it is dropped or if it is stored at less than -25 °C or above 55 °C.
NOTE
· Only the authorized personnel can adjust the data for Genius3 thermometer
equivalence modes.
Equivalence
Mode
Description
Oral Rectal
The temperature is adjusted to display an oral temperature equivalent. Oral Mode = Ear Mode -0.09 °C
The temperature is adjusted to display a rectal temperature equivalent. Rectal Mode = Ear Mode + 0.56 °C
10.4.4
Taking a Temperature
To take a temperature, follow this procedure:
1. When the monitor starts, remove the thermometer from the cradle.
2. Inspect the probe tip and make sure that the probe tip is clean. If it is soiled, clean it with a lens wipe or lint free swab.
3. Press the scan button to verify functionality and mode selection on the LCD screen.
4. Install a probe cover by firmly inserting the probe tip into a probe cover. Make sure that the probe cover is fully seated.
10 - 7
5. Place the probe in the ear canal.
6. Once positioned lightly in the ear canal, press and release the scan button.
7. Remove the probe from the ear as soon as the triple beep is heard. The temperature and probe eject icon display on the LCD screen.
8. Press the eject button to eject the probe cover.
9. Replace the thermometer to the cradle.
NOTE
· Always wait at least two minutes before taking another measurement in the
same ear.
· Do not configure the thermometer during the start-up of the monitor.
Otherwise, the thermometer data may conflict with the data that displays on the monitor.
10.4.5 Troubleshooting
Message/Issue
Cause
Temp comm abnormal
The communication between the monitor and thermometer is abnormal.
The measurement site displayed on the monitor conflicts with that on the thermometer.
During the monitor startup, the thermometer has the probe cover installed. This causes the abnormal start-up of the thermometer.
Solution
Eject and re-install the probe cover. And then measure the temperature again.
Keep the monitor power on and wait till the thermometer automatically switches off, and then press the Scan button on the thermometer.
10.4.6
Cleaning and Disinfecting the Tympanic Thermometer
Refer to the Genius 3 tethered tympanic thermometer operator's manual for cleaning and disinfection information.
10.5
Monitoring Temp with Exergen TemporalScannerTM Thermometer
The TemporalScannerTM thermometer measures the temperature of the skin over the temporal artery. Operation is based on measuring the natural thermal infrared radiation emitted from the surface of the skin over the temporal artery.
The TemporalScannerTM is a handheld infrared thermometer used by medical professionals for the intermittent measurement of human body temperature of people of all ages, by scanning the forehead skin over the temporal artery.
10 - 8
10.5.1 Safety Information
WARNING
· Use this product only for its intended use as described in this manual. · Keep the TemporalScannerTM away from electromagnet interference. · Do not take temperature over scar tissue, open sores or abrasions. · The thermometer is not shockproof. Do not drop it or expose it to electrical
shocks.
· Do not use this thermometer if it is not working properly, if it has been
exposed to temperature extremes, damaged, been subject to electrical shocks or immersed in water.
· There are no parts that you can service yourself except for the battery, which
you should replace when low by following the instructions in this manual. For service, repair, or adjustments, return your thermometer to Mindray.
· No modification of this equipment is allowed. · Never drop or insert any object into any opening, unless stated in this
manual.
· If your thermometer is not used regularly, remove the battery to prevent
possible damage due to chemical leakage.
· Follow the battery manufacturer's recommendations or your hospital policy
for the disposal of used batteries.
10.5.2 Taking a Temperature with the TemporalScannerTM
10.5.2.1 Understanding the Measurement sites
Recommended measurement sites are: temperature at the temporal artery area or temperature behind the ear.
10 - 9
Temporal Artery Area
Behind the Ear
Alternate sites when temporal artery or behind ear are unavailable:
Femoral artery: slowly slide the probe across groin.
Lateral thoracic artery: slowly scan side-to-side in the area, midway between the axilla and the nipple.
10.5.2.2 Taking a Temperature on an Infant
To take a temperature on an infant, follow this procedure:
1. Place probe flush on center of forehead and depress button. Keeping button depressed, slowly slide probe mid-line across forehead to the hair line.
2. Release button remove from head and read measurement.
NOTE
· The preferred site is the temporal artery area. Unless visibly diaphoretic, one
measurement here is typically all that is required.
· If the temporal artery is covered, then the area behind the ear, if exposed, can
be an alternate site.
· Measure straight across the forehead and not down side of face. · Brush the hair aside if covering the area to be measured. Measurement site
must be exposed.
10.5.2.3 Taking a Temperature on an Adult
To take a temperature on an adult, follow this procedure:
1. Slide across forehead. Place probe flush on center of forehead and depress button. Keeping button depressed slowly slide probe mid-line across forehead to the hair line.
2. Slide behind ear. Keeping button depressed, lift probe from forehead, touch behind ear halfway down the mastoid process and slide down to the soft depression behind the earlobe.
3. Release button and read measurement.
NOTE
· Measure only the up-side on a patient in a lateral position. The down-side will
be insulated preventing the heat from dissipating, resulting in falsely high readings.
10 - 10
· Think of a sweatband. Measure straight across the forehead and not down
the side of the face. At mid-line, the temporal artery is about 2 mm below the
surface, but can go deeply below the surface on the side of the face.
· Measure exposed skin. Brush the hair and bangs aside if covering the area to
be measured.
10.5.3
Understanding the TemporalScannerTM Thermometer LED Display
The following chart summarizes the conditions that may occur while the TemporalScannerTM is in use, and the associated indications:
Condition High Target Low Target High Ambient Low Ambient Low Battery No or Very Low Battery Processing Error
Scanning (Normal Operation)
Display HI LO HI A LO A bAtt blank display Err
- - - -
Solution/Range
>110 °F(43 °C) <61 °F(16 °C) >104 °F (40 °C) <60 °F (16 °C) / / Restart. Return to Mindray for repair if error message persists. /
10.5.4
Fahrenheit or Celsius Conversion
The TemporalScannerTM can be used in either °F or °C. To convert from one scale to the other, the only tools necessary are a paper clip and the tip of a small screwdriver.
To convert to Fahrenheit or Celsius:
1. Bend one leg of a paper clip and insert it into the hole in the side of the plastic housing.
2. Push to release the battery cover, and then remove the battery. 3. Slide the switch to left (Celsius) or right (Fahrenheit) with the tip of a screwdriver. 4. Replace battery and cover.
10 - 11
NOTE
· After converting to Fahrenheit, the readings on TemporalScannerTM and the
monitor might be slightly different. The readings on TemporalScannerTM
would be more accurate.
10.5.5
Replacing the Battery
To replace the battery, follow this procedure:
1. Bend one leg of a paper clip and insert it into the pinhole in the side of the plastic housing.
2. Push to release the battery cover, and then remove the battery. 3. Replace the battery into the compartment. 4. Reinstall the battery cover.
10.5.6 Troubleshooting
Message/Issue Cause
Solution
Abnormally low Temperature
Abnormally high temperature
Dirty Lens
Clean lens of scanner every two weeks.
Releasing the button
Release the button after finished
before finished measuring measuring.
Measuring when an ice pack or wet compress is on the forehead
Remove ice pack or wet compress, wait 2 minutes, and re-take temperature.
Measuring a completely diaphoretic patient
Complete diaphoresis includes diaphoresis of area behind the ear and suggests that the temperature is rapidly dropping. Use an alternative method of temperature measurement in these cases until the patient is dry and the temporal artery measurement can be repeated.
Improperly scanning down the side of the face
Scan straight across forehead. The temporal artery is closest to skin in that area.
Anything covering the area to be measured would insulate and prevent heat from dissipating, resulting in false high readings.
Confirm measurement site has not recently been in contact with heat insulators such as hats, blankets, and hair. Scan the area not covered or wait about 30 seconds for the previously covered area to equilibrate to the environment.
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10.5.7 Cleaning the TemporalScannerTM Thermometer
WARNING
· Never use abrasive materials (such as steel wool or silver polish), or erosive
cleaners (such as acetone or acetone-based cleaners).
· Never immerse any part of the product in liquids or allow liquid to enter the
interior.
· When cleaning or disinfecting the product, avoid pouring any liquid on the
thermometer.
You should clean the product as per your hospital's regulations after each use. Sterilization is not allowed for the product.
Cleaning the case
The TemporalScannerTM case can be wiped down using a cloth dampened with 70% isopropyl alcohol. The industrial grade housing and design of the electronic components allow for completely safe cleaning with 70% isopropyl alcohol but should not be immersed in fluid or autoclaved.
Cleaning the sensor lens
Dirt, greasy films or moisture on the lens will interfere with the passage of infrared heat and affect the accuracy of the product.
Clean the lens every two weeks with a cotton swab dipped in alcohol. Use only light force for cleaning, to avoid damaging the lens. Water can be used to remove any residual film left by the alcohol. Do not use bleach or other cleaning solutions on the sensor lens.
10.6
Monitoring Temp with HeTaida Thermometer
The HeTaida thermometer is a non-contact infrared thermometer that measures temporal temperature. It is applicable for adult, pediatric and neonatal patients. The thermometer connects with the monitor through the connector on the back.
10.6.1 Overview of HeTaida Thermometer
1
5
2
4
3 10 - 13
1. Screen: displays the Temp readings and measurement mode 2. Mode button: sets the measurement mode to Forehead or Body 3. Battery compartment: installs two AAA batteries 4. Start Measurement button: press it to turn the thermometer on and perform a
Temp measurement 5. Infrared sensor window: detects the temperature
10.6.2
Taking a Temperature with HeTaida Thermometer
To take a temperature with Hetaida Thermometer, follow this procedure: 1. Set the thermometer to Forehead mode. 2. Point the infrared sensor window to the forehead of a patient. 3. Press the Start Measurement button and read measurement.
10.7
Manually Inputting Temp
You can manually input a Temp value and save the data for future reference.
Follow this procedure:
1. Select in the Temp area. For monitors configured with Mindray SmarTempTM module, to input Temp value in Continuous Monitoring mode, press and hold in the Temp area.
2. Select a Temp Measurement Site. The options displayed in the menu is configurable. For details, refer to 18.9.3 The Temp Tab.
3. Input a measured Temp value.
4. Select the Save quick key to save the data.
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11Measuring Noninvasive Blood Pressure
(NIBP)
11.1
NIBP Introduction
The monitor uses the oscillometric method for measuring the non-invasive blood pressure (NIBP). NIBP measurement is based on the principle that pulsatile blood flow through an artery creates oscillations of the arterial wall. The oscillometric device uses a blood pressure cuff to sense these oscillations that appear as tiny pulsations in cuff pressure.
Two algorithms can be used on the monitor:
Inflation: at the inflation stage, the device effects a slow inflation of a cuff while simultaneously detects oscillations. As soon as systolic pressure is determined, the cuff is deflated. The oscillations appeared during inflation increase in amplitude to a peak amplitude (which approximates to the mean pressure) with increasing cuff pressure and then decrease in amplitude. If the measurement fails at the inflation stage, the device will automatically continue the measurement at deflation stage.
Deflation: the device measures the amplitude of pressure changes in the occluding cuff as the cuff deflates from above systolic pressure. The amplitude suddenly increases as the pulse breaks through the occlusion in the artery. As the cuff pressure decreases further, the pulsations increase in amplitude, reach a maximum (which approximates to the mean pressure), and then diminish.
The oscillometric method measures the mean pressure and determines the systolic and diastolic pressures.
NIBP measurement adopting inflation algorithm is intended for adult and pediatric patients, and NIBP measurement adopting deflation algorithm is intended for adult, pediatric, and neonatal patients.
NOTE
· Blood pressure measurements determined with this device are equivalent to
those obtained by a trained observer using the cuff/stethoscope
auscultatory method or an intra-arterial blood pressure measurement
device, within the limits prescribed by the American National Standard:
manual, electronic, or automated sphygmomanometers.
· NIBP measurement can be performed during electro-surgery and discharge
of defibrillator.
11 - 1
11.2 NIBP Safety Information
WARNING
· Be sure to select the correct patient category setting for your patient before
NIBP measurement. Do not apply the higher adult settings for pediatric or neonatal patients. Otherwise, it may present a safety hazard.
· Do not measure NIBP on patients with sickle-cell disease or on the limb
where skin damage has occurred or is expected.
· If your monitor is using inflation algorithm, select cuffs with the
symbol. Using other cuffs may lead to incorrect or failed measurements.
· Use clinical judgment to determine whether to perform frequent unattended
blood pressure measurement on patients with severe blood clotting disorders because of the risk of hematoma in the limb fitted with the cuff.
· Do not use the NIBP cuff on a limb with an intravenous infusion or arterial
catheter in place. This could cause tissue damage around the catheter when the infusion is slowed or blocked during cuff inflation.
· Do not apply cuff on the arm on the side of a mastectomy or lymph node
clearance.
· Continuous cuff pressure due to connection tubing kinking may cause blood
flow interference, and resulting in harmful injury to the patient.
· NIBP reading can be affected by the measurement site, the position of the
patient, exercise, or the patient's physiologic condition. If you doubt the NIBP measurements, determine the patient's vital signs by alternative means, and then verify that the monitor is working correctly.
· Devices that exert pressure on tissue have been associated with purpura,
ischemia, and neuropathy. Inspect the application site regularly to ensure skin quality and inspect the extremity of the cuffed limb for normal color, warmth and sensitivity. If the skin quality changes, or if the extremity circulation is being affected, move the cuff to another site or stop the blood pressure measurement immediately. Check more frequently when making automatic or STAT measurement. Auto NIBP measurement with one and two minute intervals is not recommended for extended periods of time.
· NIBP diagnostic significance must be decided by the physician.
CAUTION
· Using IABP may cause NIBP, including PR, measurements inaccurate or failed. · Only use parts and accessories specified in this manual. Follow the
instructions for use and adhere to all warnings and cautions.
11 - 2
· Accuracy of NIBP measurement depends on using a cuff of proper size. It is
essential to measure limb circumference and choose a cuff with proper size.
11.3
NIBP Measurement Limitations
Measurement is impossible with heart rate extremes of less than 30 bpm or greater than 300 bpm, or if the patient is on a heart-lung machine. The measurement may be inaccurate or impossible in the following situations:
Regular arterial pressure pulses are hard to detect With excessive and continuous patient movement such as shivering or
convulsions With cardiac arrhythmias With rapid blood pressure changes With severe shock or hypothermia that reduces blood flow to the peripheries On an edematous extremity.
NOTE
· The effectiveness of this sphygmomanometer has not been established in
pregnant, including pre-eclamptic patients.
11.4 11.5
Measurement Modes
In Spot Check mode, there are three NIBP measurement modes: Manual: measurement on demand. BP (Blood Pressure) Averaging: see 11.9 BP Averaging. Orthostatic BP measurement: see 11.10 Orthostatic BP Measurement. In Continuous Monitoring mode, there are four NIBP measurement modes: Manual: measurement on demand. Auto: repeated measurement at set interval or an interval synchronized with the
real time clock. STAT: continually rapid series of measurement over a five minute period. Sequence: continually automatic measurement at set durations and intervals.
NIBP Display
Below is an example of NIBP screen in Spot Check mode:
11 - 3
1
2 3
8
1. Time of last measurement 4
5
6
7
2. NIBP unit
3. Select this area to set the patient position and measurement site
4. Systolic pressure
5. Another measurement mode is available:
If the department is set to Physician Office, swipe on the NIBP area to the left or right to switch to BP averaging screen. For details, see 11.9 BP Averaging.
If orthostatic BP measurement is enabled, swipe on the NIBP area to the left or right to switch to orthostatic BP measurement screen. For details, see 11.10 Orthostatic BP Measurement.
6. Mean pressure (displayed after measurement completed) or cuff pressure (displayed during the measurement)
7. Diastolic pressure
8. Start/Stop NIBP measurement
Below is an example of NIBP screen in Continuous Monitoring mode:
1
12
11 10
2
3
4
9
5 1. Time of last measurement
6
78
2. NIBP unit
3. Select this area to set the patient position and measurement site
4. Systolic pressure alarm limits
5. Systolic pressure
11 - 4
6. Mean pressure (displayed after measurement completed) or cuff pressure (displayed during the measurement)
7. Diastolic pressure
8. Mean pressure alarm limits
9. Start/Stop NIBP measurement
10. Sequence information (for Sequence mode): the capital letter indicates the current phase and the time indicates the current measurement interval
11. Diastolic pressure alarm limits
12. Time to the next measurement (for Auto mode and Sequence mode)
The display of pressure values can be configured. For details, see 11.8.5 Setting the NIBP Display Format.
NOTE
· If the measurement fails, "XX" is displayed; if measurement is not taken, "--"
is displayed.
· Outlined numerics indicate that the measurement is old and exceeds the set
time. So these values are not recommended for reference.
11.6 Preparing for NIBP Measurement
11.6.1
Preparing the Patient for NIBP Measurement
In normal use, perform NIBP measurement on a patient who is in the following position:
Comfortably seated Legs uncrossed Feet flat on the floor Back, arm and feet supported For patients taking orthostatic BP measurement, refer to 11.10 Orthostatic BP Measurement.
NOTE
· It is recommended that the patient calms down and relaxes as much as
possible before performing the measurement and that the patient do not
talk during the measurement.
· It is recommended to have the patient sit quietly for several minutes before
taking the measurement.
· For known hypertensive patients, you need to set initial cuff pressure to a
higher value to reduce the measurement time.
11 - 5
· The operator should not touch the cuff or tubing during NIBP measurement. · Other factors that have been shown to result in an overestimation of blood
pressure are labored breathing, full bladder, pain etc.
11.6.2
Placing the NIBP Cuff
To place the NIBP cuff, follow this procedure:
1. Verify that the patient category setting is correct. If not, enter the Patient Management menu to change patient category. For more information, see 4.2.2 Editing Patient Information.
2. Connect the air tubing to the NIBP connector on the monitor.
3. Select an appropriate cuff for the patient, and then wrap it around the limb directly over the patient's skin as follows:
a If your monitor is using inflation algorithm, select cuffs with the symbol. Using other cuff may lead to incorrect or failed measurements.
b Determine the patient's limb circumference.
c Select an appropriate cuff by referring to the limb circumference marked on the cuff. The width of the cuff should be 40% (50% for neonates) of the limb circumference, or 2/3 of the length of the upper arm or the thigh. The inflatable part of the cuff should be long enough to encircle at least 50% to 80% of the limb.
d Apply the cuff to the patient's upper arm or leg and make sure the marking on the cuff matches the artery location. The cuff should fit snugly, but with enough room for two fingers to be placed between the cuff and the patient's arm (on adults), and loosely on neonates with little or no air present within the cuff. Otherwise it may cause discoloration and ischemia of the extremities. Make sure that the cuff index line falls within the range markings on the cuff.
e Middle of the cuff should be at the level of the right atrium of the heart. If it is not, you must use the measurement correction formula to correct the measurement. For more information, see 11.8.9 Correcting the NIBP Measurements.
4. Connect the cuff to the air tubing. Avoid compression or restriction of pressure tubes. Air must pass unrestricted through the tubing.
CAUTION
· A wrong cuff size and a folded or twisted bladder can cause inaccurate
measurements.
· Do not touch or apply external pressure against the cuff and air tubing
during NIBP measurement. This may cause inaccurate blood pressure values.
11 - 6
· Use care when placing the cuff on an extremity used for monitoring other
patient parameters.
11.7
Performing Measurement
This section describes the procedure to start manual, auto, STAT, and sequence measurement. For BP Averaging, see 11.9 BP Averaging. For Orthostatic BP measurement, see 11.10 Orthostatic BP Measurement.
11.7.1
Performing Manual Measurement
To perform manual measurement, follow this procedure:
1. Prepare the patient and place the cuff as instructed in 11.6 Preparing for NIBP Measurement.
2. Select to set the patient position and measurement site. 3. Select to start the measurement. In Spot Check mode, you can perform two times of measurement as a group for clinical evaluation. For setting of measurement times, see 11.8.8 Setting Measurement Times.
Below is an example of NIBP screen if Measurements is set to Twice:
1
98
2
3
7
4 6
5
1. Time of last measurement 2. NIBP unit 3. Patient position and site of the first measurement 4. Patient position and site of the second measurement 5. Differences between the two groups of measurements: displayed in the form of
Sys/Dia (Mean) 6. Start/Stop the second measurement 7. Start/Stop the first measurement 8. Values of the second measurement: displayed in the form of Sys/Dia (Mean) 9. Values of the first measurement: displayed in the form of Sys/Dia (Mean)
11.7.2 Performing Auto Measurement
To perform auto measurement, follow this procedure:
11 - 7
1. Prepare the patient and place the cuff as instructed in 11.6 Preparing for NIBP Measurement.
2. Select a workflow under Continuous Monitoring.
3. Select to set the patient position and measurement site.
4. Select the NIBP numeric area to enter the NIBP menu.
5. Set Interval to an appropriate duration.
6. Set Start Mode to Interval or Clock. Clock: after the first measurement, the monitor automatically synchronizes NIBP automatic measurement with the real time clock. For example, if Interval is set to 20 min, and you start NIBP auto measurement at 14: 03, the next measurement will be taken at 14: 20, and then at 14:40, 15:00, and so on. Interval: after the first measurement, the monitor automatically repeats measurement at set interval. For example, if Interval is set to 20 min, and you start NIBP auto measurement at 14:03, the next measurement will be taken at 14:23, and then at 14:43, 15:03, and so on.
7. Select Start NIBP.
11.7.3
Performing STAT Measurement
To perform STAT measurement, follow this procedure:
1. Prepare the patient and place the cuff as instructed in 11.6 Preparing for NIBP Measurement.
2. Select a workflow under Continuous Monitoring.
3. Select to set the patient position and measurement site. 4. Select the NIBP numeric area to enter the NIBP menu. 5. Select STAT.
11.7.4
Performing Sequence Measurement
To perform sequence measurement, follow this procedure:
1. Prepare the patient and place the cuff as instructed in 11.6 Preparing for NIBP Measurement.
2. Select a workflow under Continuous Monitoring.
3. Select to set the patient position and measurement site. 4. Select the NIBP numeric area to enter the NIBP menu. 5. Select Sequence tab to set the duration and interval of phases in the sequence.For
details, see 11.8.4 Setting NIBP Sequence. 6. Select Setup tab, set Interval to Sequence.
11 - 8
11.8
7. Set Start Mode to Interval. 8. Select Start NIBP.
Changing NIBP Settings
11.8.1
Setting the NIBP Alarm Properties
In Continuous Monitoring mode, you can set the NIBP alarm properties. Follow this procedure:
1. Select the NIBP numeric area to enter the NIBP menu. 2. Select the Alarm tab. 3. Enter the password if required. 4. Set alarm properties as desired.
11.8.2
Setting the NIBP Interval
For auto NIBP measurement, you need to set the interval between two times of NIBP measurement. In Continuous Monitoring mode, you can set the NIBP interval. Follow this procedure:
1. Select the NIBP numeric area to enter the NIBP menu Setup tab.
2. Set Interval. Selecting Manual switches to manual mode.
11.8.3
Enabling the NIBP End Tone
The monitor can issue a reminder tone at the completion of NIBP measurement. The NIBP End Tone is off by default. You can switch on the NIBP tone in workflow setup menu. After setting, every time you switch to the workflow, NIBP End Tone is switched on.
You can also switch on the NIBP end tone in the NIBP menu, follow this procedure:
1. In Continuous Monitoring mode, select the NIBP numeric area to enter the NIBP menu. In Spot Check mode, select the Main Menu quick key from the Parameters column select Setup select NIBP.
2. Switch on NIBP End Tone.
11.8.4
Setting NIBP Sequence
NIBP sequence measurement can have up to five phases: A, B, C, D, and E. You can individually set the duration and interval of each phase.
In Continuous Monitoring mode, you can set NIBP sequence. Follow this procedure:
1. Select the NIBP numeric area to enter the NIBP menu. 2. Select the Sequence tab. 3. Set Duration and Interval of each phase.
11 - 9
11.8.5
Setting the NIBP Display Format
To set the NIBP display format, follow this procedure:
1. In Continuous Monitoring mode, select the NIBP numeric area to enter the NIBP menu. In Spot Check mode, select the Main Menu quick key from the Parameters column select Setup select NIBP.
2. Select the Setup tab.
3. Set Display Format.
11.8.6
Setting the NIBP Alarm Limits Display Switch
In Continuous Monitoring mode, you can set whether to display the alarm limits of diastolic NIBP and mean NIBP. Follow this procedure:
1. Select the NIBP numeric area to enter the NIBP menu. 2. Select the Setup tab. 3. Switch on or off Display Alarm Limits.
11.8.7
Selecting NIBP Measurement Algorithm
You can change the NIBP measurement algorithm adopted on your monitor. Follow this procedure:
1. Select the Main Menu quick key from the System column select Maintenance
input the required password select
Module.
2. Under the NIBP tab, set NIBP Measurement Algorithm to:
Inflation: the monitor measures blood pressure during cuff inflation. If succeeded, this measurement is completed. If the measurement fails at the inflation stage, the monitor will automatically continue the measurement at deflation stage.
Deflation: the monitor measures blood pressure during cuff deflation.
Affected by measurement factors or patient's physiological conditions, inflation algorithm might fail, be incorrect, or unavailable. Then the monitor automatically continues to perform the NIBP measurement at deflation stage. The measurement factors or patient's physiological conditions include:
Excessive patient movement
Using cuffs with no
symbol
Using cuffs of inappropriate size
Cuffs being too tight or loose
Using well-worn cuffs
Patient blood pressure being too low
Patient pulse rate being too low
11 - 10
Patient having frequent arrhythmia Weak patient pulse
NOTE
· The monitor always performs NIBP measurement at deflation stage if Patient
Category is Neo.
11.8.8
Setting Measurement Times
To set the measurement times, follow this procedure:
1. Select the Main Menu quick key from the Configuration column select Workflow input the required password select .
2. Select
on the right of the workflow to be set. Make sure the workflow is
under Spot Check.
3. Select Parameters Setup.
4. Under NIBP tab, set Measurements to Twice.
11.8.9
Correcting the NIBP Measurements
The middle of the cuff should be at the level of right atrium. If the limb is not at the heart level, you need to correct the measurement:
Add 0.75 mmHg (0.10 kPa) to the displayed value for each centimetre higher. Deduct 0.75 mmHg (0.10 kPa) to the displayed value for each centimeter lower.
11.9
BP Averaging
In BP averaging mode, a group of BP measurement is performed on a patient automatically. At the completion of measurement, a group of averaged BP readings is displayed.
11.9.1
Enabling BP Averaging
BP averaging is available only when the Department is set to Physician Office and the monitor is working in Spot Check mode.
To change the department, see 5.2 Changing the Department.
To enable BP averaging, follow this procedure: 1. Select the Main Menu quick key from the Configuration column select
Workflow input the required password select .
2. Select
on the right of the workflow to be set. Make sure the workflow is
under Spot Check.
3. Select Parameters Setup the NIBP tab.
11 - 11
4. Under Average, enable BP Averaging.
11.9.2 BP Averaging Display
The following figure shows the BP averaging screen.
1 2 3
6
4
5
1. Time of last measurement
2. NIBP unit
3. Select this area to set the patient position and measurement site
4. Averaged blood pressure: displayed in the form of Sys/Dia (Mean)
5. Measurements used for averaging: if the first group of measurements is displayed with a strikethrough, it is excluded in the averaging. For details, see 11.9.4.4 Excluding the First Group of Readings in the Calculation.
6. Start NIBP measurement
11.9.3
Performing BP Averaging
Follow this procedure:
1. Prepare the patient and place the NIBP cuff as instructed in 11.6 Preparing for NIBP Measurement.
2. Swipe on the NIBP area to the left or right to switch to BP averaging screen.
3. Select
to set the patient position and measurement site.
4. Select to start the first measurement.
The monitor starts the first measurement immediately or after the set delay. For details, see 11.9.4.1 Setting the Delay before Starting the First Measurement.
After the first measurement, the monitor automatically takes several times of BP measurement (see 11.9.4.2 Setting the Number of Measurement) at the set interval (see 11.9.4.3 Setting Time between Readings).
5. At the completion of automatic measurement, select Return to check the readings of each measurement and the averaged BP values.
11 - 12
11.9.4 Changing BP Averaging Settings
11.9.4.1 Setting the Delay before Starting the First Measurement
Follow this procedure:
1. Select the Main Menu quick key from the Configuration column select Workflow input the required password select .
2. Select
on the right of the workflow to be set. Make sure the workflow is
under Spot Check.
3. Select Parameters Setup the NIBP tab.
4. Under Average, set Delay Before Starting Measurement.
11.9.4.2 Setting the Number of Measurement
Follow this procedure:
1. Select the Main Menu quick key from the Configuration column select Workflow input the required password select .
2. Select on the right of the workflow to be set. Make sure the workflow is under Spot Check.
3. Select Parameters Setup the NIBP tab.
4. Under Average, set Number of Measurements.
11.9.4.3 Setting Time between Readings
You can set the time duration between the starts of two consecutive measurement. Follow this procedure:
1. Select the Main Menu quick key from the Configuration column select Workflow input the required password select .
2. Select on the right of the workflow to be set. Make sure the workflow is under Spot Check.
3. Select Parameters Setup the NIBP tab.
4. Under Average, set Time Between Readings.
11.9.4.4 Excluding the First Group of Readings in the Calculation
You can choose to exclude the first group of readings in the averaging calculation. Follow this procedure:
1. Select the Main Menu quick key from the Configuration column select Workflow input the required password select .
2. Select on the right of the workflow to be set. Make sure the workflow is under Spot Check.
11 - 13
3. Select Parameters Setup the NIBP tab. 4. Under Average, enable Discard First Group of Readings.
11.10 Orthostatic BP Measurement
Orthostatic blood pressure is important for the assessment of fall risks. On the monitor, you can measure the lying and standing blood pressure of a patient, and check the differences for clinical evaluation. Orthostatic BP measurement is only applicable for adult patient.
A license is required for the orthostatic BP measurement function. To check the license, see 3.9.9 Checking Software Licenses.
11.10.1 Enabling Orthostatic BP Measurement
Orthostatic BP measurement is available only when the monitor is working in Spot Check mode.
To enable Orthostatic BP measurement, follow this procedure:
1. Select the Main Menu quick key from the Configuration column select Workflow input the required password select .
2. Select on the right of the workflow to be set. Make sure the workflow is under Spot Check.
3. Select Parameters Setup the NIBP tab.
4. Under Orthostatic BP Measurement, enable Orthostatic BP Measurement.
11.10.2 Orthostatic BP Measurement Display
The following figure shows the orthostatic BP measurement screen.
8 1
2
7
3
6 4
5
1. NIBP unit 2. Lying blood pressure: displayed in the form of Sys/Dia (Mean) 3. Standing blood pressure: displayed in the form of Sys/Dia (Mean). The lowest val-
ues measured are used in contrasting. 4. Differences between the lying blood pressure and lowest standing blood pressure
11 - 14
5. Evaluation result based on the set criteria: Negative: the differences are within the acceptable range as per the set criteria. Positive: the differences are out of the acceptable range as per the set criteria.
For details, see 11.10.4.5 Setting Orthostatic BP Evaluation Criterion.
6. Start/Stop standing blood pressure measurement before measurement and clear data after measurement
7. Start/Stop lying blood pressure measurement
8. Add patient symptoms for result evaluation
11.10.3 Performing Orthostatic BP Measurement
Follow this procedure:
1. Place the NIBP cuff as instructed in 11.6.2 Placing the NIBP Cuff.
2. Swipe on the NIBP area to the left or right to switch to the orthostatic BP measurement screen.
3. Ask the patient to lie flat on the back and select on the top to take lying BP measurement. The monitor waits for a preset duration and starts measurement automatically. The time duration is configurable. For details, see 11.10.4.1 Setting the Lying Duration of Patient.
4. After the lying BP measurement is completed, ask the patient to stand up. Within 1 minute, select on the bottom. The monitor automatically takes several times of standing BP measurement, depending on your setting of Standing BP Measurement Interval and Maximum Standing BP Measurements. For details, see 11.10.4.2 Setting Standing BP Measurement Interval and 11.10.4.3 Setting the Times of Standing BP Measurement.
5. Select symptoms if necessary. The list of symptoms are configurable. For details, see 11.10.4.4 Setting Orthostatic BP Symptoms.
6. Upon completion of measurement, the evaluation result is displayed in the NIBP area. Select Negative or Positive to check for details.
11.10.4 Changing Orthostatic BP Measurement Settings
11.10.4.1 Setting the Lying Duration of Patient
Follow this procedure:
1. Select the Main Menu quick key from the Configuration column select Workflow input the required password select .
2. Select
on the right of the workflow to be set. Make sure the workflow is
under Spot Check.
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3. Select Parameters Setup the NIBP tab. 4. Under Orthostatic BP Measurement, set Lying Duration.
11.10.4.2 Setting Standing BP Measurement Interval
Follow this procedure: 1. Select the Main Menu quick key from the Configuration column select
Workflow input the required password select .
2. Select
on the right of the workflow to be set. Make sure the workflow is
under Spot Check.
3. Select Parameters Setup the NIBP tab.
4. Under Orthostatic BP Measurement, set Standing BP Measurement Interval.
11.10.4.3 Setting the Times of Standing BP Measurement
Follow this procedure:
1. Select the Main Menu quick key from the Configuration column select Workflow input the required password select .
2. Select
on the right of the workflow to be set. Make sure the workflow is
under Spot Check.
3. Select Parameters Setup the NIBP tab.
4. Under Orthostatic BP Measurement, set Maximum Standing BP Measurements.
11.10.4.4 Setting Orthostatic BP Symptoms
Follow this procedure:
1. Select the Main Menu quick key from the System column select Maintenance
input the required password select
Module.
2. Under Orthostatic BP Symptoms, select
to edit a symptom. You can also
select Add Symptom to create a new symptom and then select
to edit it.
NOTE
· You can set up to ten symptoms.
11.10.4.5 Setting Orthostatic BP Evaluation Criterion
You can set criteria for evaluation of the pressure differences. A negative/positive result displays on the screen at the completion of the measurement.
Follow this procedure:
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1. In Spot Check mode, select the Main Menu quick key from the System column
select Maintenance input the required password select
Module.
2. Under Evaluation Criterion, select rion to create a new one.
to edit an existing criterion or Add Crite-
3. Set the Parameter, Type, Threshold, and select With Symptoms to set whether to include symptoms in the criterion.
4. Select Save.
11.11 Assisting Venous Puncture
You can use the NIBP cuff to cause sub-diastolic pressure to block the venous blood vessel and therefore help venous puncture. To assist venous puncture, follow this procedure:
1. In Continuous Monitoring mode, select the NIBP numeric area to enter the NIBP menu. In Spot Check mode, select the Main Menu quick key from the Parameters column select Setup select NIBP.
2. Set Venipuncture Pressure.
3. Select Venipuncture at the bottom of the menu.
4. Puncture vein and draw blood sample.
5. Select the Venipuncture again to deflate the cuff. If you do not deflate the cuff, the cuff automatically deflates after a period of time (170 seconds for adult and pediatric patient, 85 seconds for neonatal patient).
During venous puncture, pay attention to the cuff pressure and the remaining time displayed in the NIBP numerics area.
NOTE
· This function is not available on VS 9A and VS 8A monitors.
11.12 NIBP Maintenance
11.12.1 NIBP Leakage Test
The NIBP leakage test checks the integrity of the system and of the valve. The NIBP leakage test should be performed once every two years or when you doubt the NIBP measurements. The NIBP leakage test should be performed by Mindray-qualified service personnel only.
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11.12.2 NIBP Accuracy Test
The NIBP accuracy test should be performed once every two years or when you doubt the NIBP measurements. The NIBP accuracy test should be performed by Mindrayqualified service personnel only.
11.13 NIBP Troubleshooting
For more information, see D Alarm Messages.
11 - 18
12 Monitoring CO2
12.1 12.2
Overview
CO2 monitoring is a continuous, non-invasive technique for determining the concentration of CO2 in the patient's airway by measuring the absorption of infrared (IR) light of specific wavelengths. CO2 has its own absorption characteristic and the amount of light passing the gas probe depends on the concentration of the measured CO2. When a specific band of IR light passes through respiratory gas samples, some of the IR light will be absorbed by the CO2 molecules. The amount of IR light transmitted after it has been passed through the respiratory gas sample is measured with a photodetector. From the amount of IR light measured, the concentration of CO2 is calculated.
The CO2 measurement is to monitor the patient's respiratory status.
CO2 monitoring is intended for adult, pediatric and neonatal patients.
CO2 monitoring is for VS 9 series only.
CO2 measurement is available when the monitor is in Continuous Monitoring mode.
Safety
WARNING
· Remove the airway sampling line from the patient's airway while nebulized
medications are being delivered.
· Leakage in the breathing or sampling system may cause the displayed EtCO2
values to be significantly low. Always make sure that all components are
securely connected.
· EtCO2 values measured from the CO2 module may differ from those of from
the blood gas analysis.
· Route all tubing away from the patient's throat to avoid strangulation. · Inspect the airway for a tight connection and make proper settings before
attaching it to the patient.
· Squeezing or bending the sampling line during the CO2 measurement may
cause inaccurate CO2 reading or no reading.
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12.3 12.4
Measurement Limitations
The following factors may influence the measurement accuracy: Leaks or internal venting of sampled gas Mechanical shock Cyclic pressure up to 10 kPa (100 cmH2O) Other sources of interference, if any Measurement accuracy may be affected by the breath rate and inspiration/expiration ratio (I: E ratio) as follow: EtCO2 value is within specification for breath rate 60 bpm and I/E ratio 1:1; EtCO2 value is within specification for breath rate 30 bpm and I/E ratio 2:1. Measurement accuracy is unspecified for breath rate larger than 60 bpm.
CO2 Display
The CO2 numeric and waveform areas provide FiCO2 measurement, EtCO2 measurement, RR measurement and a CO2 waveform.
3
4 5 1
2
1. CO2 waveform
2.
End tidal CO2 value (EtCO2)
3.
Fraction of inspired CO2 (FiCO2)
4.
RR (Respiration Rate)
5.
RR source: indicates the source of the current RR value
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12.5
Measuring CO2
CAUTION
· Eliminate the exhausted gas before performing the measurement. · Connect an exhaust tube to the gas outlet connector of the monitor to vent
the calibration gases to a scavenging system.
· Check that the alarm limit settings are appropriate before taking
measurement.
To measure CO2, follow this procedure: 1. Select an appropriate sampling line according to the patient category.
2. Connect the sampling line to the CO2 adapter that is installed on the monitor.
CO2 adapter
Sampling line 3. Connect the other end of the sampling line to the patient.
For intubated patients requiring an airway adapter, install the airway adapter between the patient circuit and the ventilator Y-piece. Sampling line
Connect to the ventilator Airway adapter Connect to the patient For non-intubated patients, place the nasal cannula onto the patient as shown in the figure below.
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4. Connect the CO2 gas outlet to the scavenging system with an exhaust tube.
CO2 can be measured after the start-up is complete.
NOTE
· When sample gas of 37 °C, sample flowrate of 50 ml/min, room temperature
of 23 °C, 100% RH, the sampling line with a general type should be replaced once at most every 8 hours, and the sampling line with a humidified type should be replaced once at most every 72 hours.
· If not necessary, do not disconnect the CO2 adapter from the equipment after
the first installation.This reduces the risk of the CO2 adapter becoming lost or damaged.
12.6
Automatic CO2 Module Zeroing
The CO2 module performs zero calibration automatically when needed.
NOTE
· The CO2 module temporally stops measuring during zeroing.
12.7
12.7.1
Changing CO2 Settings
Changing CO2 Alarm Settings
In Continuous Monitoring mode, you can change the CO2 alarm settings. Follow this procedure:
1. Select the CO2 numeric area or waveform area to enter the CO2 menu. 2. Select Alarm tab.
3. Set the following alarm properties:
Switch on or switch off the alarms. Adjust the alarm limits and alarm priority.
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12.7.2
Setting the CO2 Waveform
In Continuous Monitoring mode, you can set the CO2 waveform. Follow this procedure:
1. Select the CO2 numeric area or waveform area to enter the CO2 menu. 2. Select Setup tab.
3. Set Waveform Type, Speed and CO2 Scale of the CO2 waveform.
Select Waveform Type and toggle between Draw and Fill.
Draw: The CO2 wave is displayed as a curved line. Fill: The CO2 wave is displayed as a filled area.
Select Speed and then select the appropriate setting. The faster the wave
sweeps, the wider the wave is.
Select CO2 Scale and then change the size of the CO2 waveform.
12.7.3
Entering the Standby Mode
In Continuous Monitoring mode, you can set the CO2 module to one of the following modes according to the module status:
Select Measure mode when you use the CO2 module for monitoring. Select Standby mode when you does not use the CO2 module to prolong the
service life of the CO2 module. The default operating mode is Measure. If you are not using the CO2 module, you can proceed as follows to enter the Standby mode:
1. Select the CO2 numeric area or waveform area to enter the CO2 menu. 2. Select Setup tab.
3. Set Operating Mode to Standby.
12.7.4
Setting the Auto Standby
The monitor enters the standby mode automatically after the configured period of time if no breath is detected since the last detected breath.
To set the auto standby, follow this procedure:
1. Select the CO2 parameter area or waveform area to enter the CO2 menu. 2. Select Setup tab. 3. Set Auto Standby.
12.7.5
Setting Humidity Compensation
The CO2 modules is configured to compensate CO2 readings for either Body Temperature and Pressure, Saturated Gas (BTPS), to account for humidity in the patient's breath, or Ambient Temperature and Pressure, Dry Gas (ATPD).
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ATPD: Pco2(mmHg) = CO2(vol%) × Pamb / 100 BTPS: Pco2(mmHg) = CO2(vol%) × (Pamb 47) / 100 Where, PCO 2 = partial pressure, vol % = CO2 concentration, Pamb = ambient pressure, and unit is mmHg.
To set the humidity compensation, follow this procedure:
1. Select the CO2 numeric area or waveform area to enter the CO2 menu. 2. Select Setup tab.
3. Set BTPS Compensation to On or Off.
12.7.6
Setting Gas Compensation
The presence of interfering gas affects the CO2 measurement. To get the best possible measuring result, it is needed to set the gas compensation. The configured concentration of the interfering gas should be in accordance with its actual proportion.
WARNING
· Make sure to use the appropriate compensations. Inappropriate
compensations may cause inaccurate measurement values and result in misdiagnosis.
To set the gas compensation, follow this procedure:
1. Select the CO2 numeric area or waveform area to enter the CO2 menu. 2. Select Setup tab. 3. Set the O2, N2O and AG compensation according to the actual amount of the
respective gas in the ventilation gas mixture.
12.7.7 Automatic Barometric Pressure
The CO2 module has the function of automatic barometric pressure compensation.
12.7.8
Calibrating the CO2 Module
A calibration should be performed once a year or when the readings go far beyond the range. To calibrate the CO2 module, contact your service personnel.
CAUTION
· Connect the gas outlet to the scavenging system when calibrating the CO2
module.
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13 Monitoring Respiration
13.1 Resp Safety Information
WARNING
· The respiration measurement does not recognize the cause of apneas. It only
indicates an alarm if no breath is detected when a pre-adjusted time has elapsed since the last detected breath. Therefore, it cannot be used for diagnostic purpose.
· If operating under conditions according to the EMC Standard IEC 60601-1-2
(Radiated Immunity 3V/m), field strengths above 3V/m may cause erroneous measurements at various frequencies. Therefore, it is recommended to avoid the use of electrically radiating equipment in close proximity to the respiration measurement unit.
CAUTION
· Only use parts and accessories specified in this manual. · Respiration monitoring is not for use on the patients who are very active, as
this will cause false alarms.
13.2
RR Display
The RR parameter area displays its source.
Sourced from CO2 1
Sourced from Mindray SpO2 1
2
2
3
4
5
1. RR: Respiration rate per minute
5
6
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13.3 13.4 13.5
2. RR unit 3. RR high limit 4. RR low limit 5. RR Source: it can be SpO2, CO2 or Manual. 6. Select to input RR manually: displays only in Spot Check mode, or when CO2 is not
configured.
Measurement Limitations of SpO2-Sourced RR
The following factors may influence the accuracy of RR measurement sourcing from SpO2: Low perfusion Excessive motion on the measurement site Arhythmia RR signal too weak to be detected in the pleth waveform
Manually Inputting RR Value
To manually input an RR value, follow this procedure: 1. Select in the Resp area. A 60s timer is displayed and starts counting seconds. 2. Count the total number of Resp of the patient in the past minute. 3. Input the number and select . 4. Select the Save quick key to save the data.
Changing the RR Settings
13.5.1
Enabling SpO2 Source for RR Measurement
In Spot Check mode, you can enable the SpO2 source. Follow this procedure:
1. Select the Main Menu quick key from the System column select Maintenance input the required password select .
2. Select Module Other.
3. Switch SpO2 Calc RR on.
13.5.2
Enabling RR Alarms
In Continuous Monitoring mode, you can enable the RR alarm. Follow this procedure:
1. Select the CO2 numeric area or waveform area to enter the CO2 menu. 2. Select Alarm tab.
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3. Switch on RR.
13.5.3
Setting RR Alarms
In Continuous Monitoring mode, you can set the RR alarm limits. Follow this procedure:
1. Select the CO2 numeric area or waveform area to enter the CO2 menu. 2. Select Alarm tab. 3. Set the high and low limits and the priority in the RR row.
13.5.4
Setting the Apnea Alarm Delay
The monitor will alarm if the patient has stopped breathing for longer than the preset Apnea time.
In Continuous Monitoring mode, you can set the Apnea delay time, follow this procedure:
1. Select the CO2 numeric area or waveform area to enter the CO2 Setup menu. 2. Select Apnea Delay and then select the appropriate setting.
13.5.5
Setting Timer Interval
A timer is provided when manually inputting RR value. A reminder is given at a set interval to assist in counting of Resp number. To set the timer reminding interval for manual RR, follow this procedure:
1. Select the Main Menu quick key from the Configuration column select Workflow input the required password select .
2. Select
on the right of the workflow to be set.
3. Select Parameters Setup RR tab.
4. Set Timer Reminder Interval as needed.
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14Manual Parameters
14.1 14.2
The monitor supports inputting physiological information of a patient manually for clinical evaluation and record. The information can be saved for future reviewing, printing, or sending to other devices.
Manual Input Parameters
Below is a list of manual parameters provided by default: Blood Sugar Height Weight FiO2 O2 Flow Rate I/O Fluid LOC (GCS) LOC (AVPU) O2 Source LOC (ACVPU) Supp. O2 You can also add new types of parameters to the list. For details, refer to 14.4.2 Adding a New Parameter.
The Manual Input Display
The following figure shows the manual input area. Your display may be configured to look different.
1
2
3
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(1) * symbol: indicates the parameter can be used for EWS calculation. (2) Parameter name (3) Parameter setup area: select to input a value, show the options, or a setup menu.
14.3
If you need to change the parameters to be displayed or their sequence in the list, refer to 14.4.1 Changing the Display of Manual Parameters.
Inputting/Editing Parameter Information
Follow this procedure:
1. Select a parameter in the list, and input the information as instructed below:
: input a value with the popup on-screen keyboard, or set the parameter
in the displayed menu.
: select an option from the popup list.
The range or options of the parameters are shown below:
Parameter Blood Sugar Height Weight FiO2 O2 Flow Rate I/O Fluid
LOC (GCS) LOC (AVPU) O2 Source
LOC (ACVPU)
Supp. O2
Range
1.0 mg/dl -720.0 mg/dl (0.06 mmol/L -40.00 mmol/L) 20.0 cm - 300.0 cm 0.1 kg -499.0 kg 21% ~100%
0.1 L/min -20.0 L/min
1-10000 ml 0.001 - 10.000 L 3-15 Alert, Reacting to voice, Reacting to pain, Unresponsive Room Air, Aerosol Mask, Bi PAP, C PAP, Face Mask, Mask, Bnasal Cannula, Nonrebreather, Partial Rebreather, T-piece, Trach Collar, Ventilator, Venturi Mask, Oxymizer Alert, Confusion, Reacting to voice, Reacting to pain, Unresponsive Yes, No
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2. Select the Save quick key to save the data.
NOTE
· The input information can be reviewed, printed or sent to other devices only
after being saved. If not saved, the information may be lost after a patient is discharged or workflow is switched.
14.4 Changing Manual Input Settings
14.4.1
Changing the Display of Manual Parameters
To change the parameters to be displayed or their sequence in the list, follow this procedure:
1. Select the Main Menu quick key from the Configuration column select Workflow input the required password select .
2. Select the
on the right of the workflow to be set. Select an area and from the
popup list, select Manual Param.
3. Select Parameters Setup Manual Input tab. Then select an item and from the popup list, select the parameter to be displayed.
4. Return to the main screen and switch workflows for the setting to take effect.
14.4.2
Adding a New Parameter
If you need to add other manual parameters to the Manual Input list, follow this procedure:
1. Select the Main Menu quick key from the System column select Maintenance input the required password select .
2. Select Module Manual Input tab, and then select Add.
3. Select Name and input the name of the new parameter with the on-screen keyboard.
4. Set Type to Numeric or Text.
NOTE
· The type of a parameter cannot be changed after saving.
5. For Numeric type, continue to set the Unit and Resolution of the parameter. For Text type, you need to set the options to be selected. At least 2 options need to be set. If needed, you can select Add to set more options.
6. Select Save.
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After saving the setting, you can follow the procedure in 14.4.1 Changing the Display of Manual Parameters to add the new parameter to the Manual Input list displayed on the screen.
14 - 4
15Clinical Assistive Applications (CAA)
15.1
The Clinical Assistive Applications (CAA) function integrates some commonly used clinical guidelines and tools into the monitor. It puts the currently monitoring parameter measurements together and provides comprehensive analysis results.
CAA is not intended to replace the competent judgment of a clinician. It must be used in conjunction with observation of clinical signs and symptoms.
Early Warning Score (EWS)
The Early Warning Scores (EWS) can help you recognize the early sign of deterioration in patients based on vital signs and clinical observations. Depending on the score calculated, appropriate recommendations are displayed.
The monitor supports the following scores:
MEWS (Modified Early Warning Score)
NEWS (National Early Warning Score)
NEWS2 (National Early Warning Score 2)
Custom Score
There are two types of scoring tools:
Total score: A subscore is given for each parameter based on the measured or entered value. When all the required parameters are entered or measured, the subscores are added together to calculate the total early warning score. Each subscore has a color coding to indicate associated level of risk, When the total score is outside of the thresholds, actions are recommended. MEWS, NEWS and NEWS2 can give total scores.
IPS (individual parameter score): A color-coded score is given for each parameter based on the measured or entered value. Each parameter has upper and lower thresholds. When an individual parameter measured or entered is outside of the thresholds, actions are recommended.
Custom Score is based on user-defined parameters. It can be a total score or an IPS, depending on the configuation.
MEWS, NEWS and NEWS2 are intended for adult patients only. The patient category applied to the Custom Score is defined by Mindray Clinical Score Configuration Tool. For more information, see Mindray Clinical Scoring Config Tool Instruction for Use (P/N: 046007126-00).
15 - 1
WARNING
· EWS should not be used as the sole basis for diagnosis or therapy decisions. It
is not intended to replace the competent judgment of a clinician.The EWS scores and recommended actions must be used in conjunction with observation of clinical signs and symptoms.
· MEWS and NEWS are not applicable to pregnant woman, COPD (Chronic
Obstructive Pulmonary Disease) patients and patients under 16 years old. NEWS2 is not applicable to pregnant woman and patients under 16 years old.
15.1.1 The EWS Display
The following figure shows the EWS screen.
1
8
2
7
3 6
4
5
1. EWS protocol label
2. The current scoring time
3. Total score. The color of the circle indicates the level of risk. For IPS, no score is displayed. Only level of risk is shown: white means normal and red indicates alert.
4. Risk level indicator. The level of risk increases from top down. The current level is enclosed by a white square frame. For IPS, this indicator does not display.
5. Subscore area: displays the subscore of each parameter.
6. Reset (available in Continuous Monitoring mode): select this button to clear the previous score.
7. Calculate (available in Continuous Monitoring mode): select this button to calculate the total score. It is available when all parameter values used for scoring are obtained automatically.
8. SpO2 scale (for NEWS2 only): displays the current SpO2 scale used for scoring. Select this area to change to another scale.
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15.1.2
Accessing the EWS Screen
Access the EWS window in any of the following ways:
Select the EWS parameter area Select the Main Menu quick key from the CAA column select EWS.
Take NEWS2 as an example, the EWS screen is shown as follows. Your screen may be slightly different due to the configuration.
10
9
8
1
7
6 2
5
3
4
1. Total score. The color of the circle indicates the level of risk. For IPS, no numeric score is displayed. Only level of risk is shown: white means normal and red indicates alert by default.
2. Risk level indicator. The level of risk increases from top down. The current level is enclosed by a white frame. For IPS, this indicator does not display.
3. Parameter area: display the value of each parameter.
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4. Subscore area: display the subscore of each parameter. 5. Keyboard symbol: indicates that the value is manually entered. 6. Selecting this button to see the clinical response to the current score. 7. Scoring interval (available in Continuous Monitoring mode) 8. Scoring countdown (available in Continuous Monitoring mode): time to the next
scoring. 9. EWS protocol label 10. The scoring time (available in Continuous Monitoring mode)
15.1.3
EWS Scoring in Spot Check Mode
In Spot Check mode, EWS scoring is performed automatically.
After a parameter value is obtained, the monitor calculates the subscore of the parameter. If all parameters required for EWS scoring are obtained, the monitor calculates the total score automatically.
If any of the parameter value changes, the subscore and total score are recalculated accordingly.
NOTE
· Observe the parameter and score changes and save the data timely.
15.1.4 EWS Scoring in Continuous Monitoring Mode
15.1.4.1 Performing EWS Scoring
To perform scoring, follow this procedure:
1. Select Reset to clear the previous score and update values of currently monitored parameters and relevant subscores.
2. For NEWS2, set the SpO2 Scale. Scale 1: for patient without hypercapnic respiratory failure. Scale 2: for patients with a prescribed oxygen saturation requirement of 88 92% (for example, in patients with hypercapnic respiratory failure).
3. Measure or manually enter other required parameters and observations. 4. Select Calculate to get the total score. 5. If Score Confirmation is enabled, select Confirm to save current scoring, or select
Cancel to give up current scoring. Refer to section 15.1.6.2 Setting the Score Confirmation Switch for more information.
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NOTE
· The decision to use Scale 2 of the SpO2 Scale should be made by a competent
clinical decision maker and should be recorded in the patient's clinical notes.
· Before calculating the score, select Reset to clear the previous score. · You can get the score only when all required parameters have been measured
or entered.
15.1.4.2 Enabling Auto Scoring
In Continuous Monitoring mode, the monitor automatically starts scoring at the preset interval. To enable auto scoring, follow this procedure:
1. From the EWS page select Setup.
2. Set Auto Scoring: Interval: the monitor automatically starts scoring at the preset interval. NIBP: the monitor automatically starts scoring at the completion of each NIBP measurement. Alarm: the monitor automatically starts scoring when an alarm occurs to the parameter for scoring. If no option is selected, the monitor does not initiate auto scoring.
15.1.4.3 Setting Auto Scoring Interval
In Continuous Monitoring mode, you can set the auto scoring interval. Follow this procedure:
1. From the EWS page select Setup.
2. Set Interval: By Score: the monitor automatically starts scoring as per the interval selected for corresponding total score. 5 min - 24 hrs: If Auto Scoring is set to Interval, the monitor automatically starts scoring as per the selected interval. If Auto Scoring is not set to Interval, the countdown timer of manual scoring is selected. Off: the monitor does not automatically start scoring.
15.1.5
EWS Alarm
When working under Continuous Monitoring mode, if alarms are enabled, the monitor can automatically give alarms and refreshes the score.
15.1.5.1 Setting the EWS Alarm
In Continuous Monitoring mode, if Alarm is enabled, the monitor can automatically give alarms in the following cases:
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The total score exceeds the configured threshold The score of auto obtained parameter is 3. To configure the EWS alarm, follow this procedure: 1. From the EWS page select Setup. 2. Select the Alarm tab. 3. Turn on the Alarm switch. 4. Set the alarm switches for the single parameters listed in the 3 in single
parameter area. 5. Set the alarm switch and threshold of the total score in the EWS Score area.
15.1.5.2 Auto Refreshing Scores
If Auto Refresh Scores is enabled, the monitor can automatically refresh the total score in the following cases: The total score reaches the configured threshold, or falls from the configured
threshold to a lower score. The score of auto obtained parameter reaches 3, or falls from 3 to a lower score. To enable the auto refreshing score function, follow this procedure: 1. From the EWS page select Setup. 2. Select the Alarm tab. 3. Turn on the Auto Refresh Scores switch.
15.1.6 Changing EWS Settings
15.1.6.1 Changing the Scoring Protocol
The monitor is configured with a default scoring protocol. To change the scoring protocol, follow this procedure: 1. From the EWS page select Setup. 2. Set Score.
15.1.6.2 Setting the Score Confirmation Switch
In Continuous Monitoring mode, you can select if confirmation is required before saving score. Follow this procedure: 1. From the EWS screen select Setup. 2. Set Score Confirmation switch.
Off: the monitor automatically saves the scoring result after the scoring is completed.
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On: you need to confirm that whether the scoring result is saved or not after the scoring is completed.
15.1.6.3 Setting the Manual Data Timeout
The manually input parameter data become invalid after a preset time. To set the timeout period for the input data, follow this procedure:
1. From the EWS screen select Setup.
2. From the Manual Data Timeout area, select a desired parameter and set its timeout period.
NOTE
· If the data is expired and not updated, the monitor displays the
corresponding parameter score in outline font, and gives a timeout alarm.
15.1.6.4 Selecting the Default Scoring Tool
To set the default scoring tool for different patient catalog, follow this procedure:
1. Select the Main Menu quick key from the System column select Maintenance input the required password select .
2. Select the CAA tab select EWS tab.
3. From the Select Default Score area, set Default Adult Score, Default Ped Score, and Default Neo Score.
15.1.7
Viewing History Scores
To view the history scores, follow this procedure: 1. Select the Review quick key select Scoring Review tab. 2. Select PID and from the popup list select the ID of which the scores are to be
viewed. 3. Select Filter and choose a protocol if needed. 4. Select a record and then select Detail.
15.1.7.1 Managing the Scoring Tools
To manage the scoring tool, follow this procedure:
1. Select the Main Menu quick key from the System column select Maintenance input the required password select .
2. Select the CAA tab select EWS tab.
3. Select Manage Score. Delete local scoring tools: from the Local page, delete the unnecessary scoring tools.
15 - 7
Import the desired scoring tools to the monitor: connect a USB drive to the monitor's USB port. From the USB Drive page, select the scoring tools on the USB drive, and then select Import.
2
NOTE
· The monitor provide MEWS, NEWS, and NEWS2 by default. You cannot delete
them.
· For details about how to import scoring tools, refer to Mindray Clinical
Scoring Config Tool Instruction for Use (P/N: 046-007126-00).
15.2
Glasgow Coma Scale (GCS)
The Glasgow Coma Scale (GCS) function is based on 1974_Lancet_ Teasdale Assessment of Coma and Impaired Consciousness-A Practical Scale. Three aspects of behavior are independently measured: eye opening, verbal response, and motor response. The scores are added together to indicate that patient's level of consciousness.
GCS is intended for adults and pediatric patients.
CAUTION
· GCS is intended as an adjunct in patient assessment and must be used in
conjunction with observation of clinical signs and symptoms.
· GCS is not applied to patients that are sedated, muscularly relaxed, with
artificial airway, drunk, or in status epilepsies.
· GCS is not applied to deaf people and patients having language barrier or
with mental disorder.
· When applied to children younger than five years old or elder people who are
slow, the GCS score might be low.
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15.2.1 GCS Display
The GCS value displays in the Manual Input list, as shown below:
1
2
1 GCS label 2 GCS value: total score. Select this area to enter the GCS menu.
Your display may look slightly different. If GCS is not displayed, you can follow the procedure in 14.4.1 Changing the Display of Manual Parameters to add GCS to the list.
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15.2.2 Accessing the GCS Menu
Select the GCS value to enter the GCS menu.
1
1 2 3
1
1 Subscores 2 Total score and level of consciousness. The color of the circle indicates the level of
risk. 3 Scoring time
15.2.3 Performing GCS Scoring
To perform scoring, follow this procedure:
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1. From the Eye Opening area, Verbal Response area, and Motor Response area, respectively select an item that represents the patient's status.
2. Select OK to accept the total score.
3. Select the Save quick key to save GCS scoring. The following table lists the default score range and color of relevant consciousness level.
Level Mild
Range 13 to15
Moderate 9 to 12
Severe
3 to 8
Color White Yellow Red
Description
The brain function is normal or mildly damaged.
The brain function is suffered from moderate to severe damage.
Can be brain death or remain vegetative.
15.2.4
Setting Threshold for Each Consciousness Level
You can configure the threshold of each consciousness level. To do so, follow this procedure:
1. Select the Main Menu quick key from the System column select Maintenance input the required password select .
2. Select the CAA tab select the GCS tab.
3. Set high limit and low limit for each level.
15.2.5
Reviewing GCS Data
If the GCS data is correctly saved, you can review the GSC data following this procedure: 1. Select the Review quick key select Scoring Review tab. 2. Select a record from the list, and then select Detail. 3. Check the LOC(GCS) value.
15.3
Pain Score
The monitor provides pain score functions to help assess a patient's pain. The following scales are provided by default:
VAS-cm: a visual analog scale of 0 to10 cm. VAS-mm: a visual analog scale of 0 to 100 mm. NRS: a numeric rating scale, using numbers to rate the pain. VRS-5: a verbal rating scale of 0 to 5.
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FPS-R: face pain scale revised. FLACC: stands for face, legs, activity, crying, and consolability. You can also add custom pain scores to the list. For details, refer to 15.3.3 Adding a Custom Pain Scale.
Pain Score is applicable for adult, pediatric, and neonatal patients.
15.3.1
The Pain Score Display
The following figure shows the pain score screen. Your display may be configured to look different.
1
4
2
3
(1) The name of currently used pain scale
(2) Scoring area: selecting this area to select a value or an option from the popup list for total scoring.
(3) Indicating the number of pain scales currently selectable
(4) Adding pain description
15.3.2
Performing Pain Score
Follow this procedure: 1. Swipe on the Pain Score screen to the left or right to select a pain scale. 2. Set the pain description if needed. 3. Tap the scoring area to select a value or an option for scoring. 4. Select the Save quick key to save the data.
15.3.3
Adding a Custom Pain Scale
You can set up to 2 custom pain scales on the monitor. Follow this procedure:
1. Select the Main Menu quick key from the System column select Maintenance input the required password select .
2. Select Module Pain Score tab.
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3. Under Custom Pain Score Method, select corresponding area to edit the name of your scale, and change the upper limit of scoring value.
4. Enable Display on the right of the pain score for it to be displayed on the Pain Score screen.
15.3.4
Adding a Pain Description
You can add up to 15 descriptions on the monitor. Follow this procedure:
1. Select the Main Menu quick key from the System column select Maintenance input the required password select .
2. Select Module Pain Score tab, and then select Add Description. 3. Select Name and input the name of the description with the on-screen keyboard. 4. Set Type to Numeric or Text.
NOTE
· The type of a description cannot be changed after saving.
5. For Numeric type, continue to set the Unit and Resolution of the parameter. For Text type, you need to set the options to be selected. At least 2 options need to be set. If needed, you can select Add to set more options.
6. Select Save.
15.4
Targeted Goal
For patients under continuous monitoring, if you are concerned with specific parameters and their trends, you can use the Targeted Goal screen. The Targeted Goal screen focuses on the target parameter and displays parameter measurements in big numerics. You can easily identify whether parameter target is reached via a dashboard and review the statistics of the target parameter by sections.
The Targeted Goal screen displays parameter measurements and waveforms of SpO2, PI, PR, NIBP, and Temp. The measurements of these parameters displays in big numerics.
15.4.1
Entering the Targeted Goal Screen
To enter the Targeted Goal screen, in Continuous Monitoring mode, select Targeted Goal quick key.
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15.4.2 The Display of the Targeted Goal Screen
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6
2 5
3
4
1. Target parameter area: displays the SpO2 measurement in big numerics, as well as its target range, and alarm limits. The dashboard shows the target range in green.
The pointer below the dashboard indicates the current measurement value.
2. Target parameter waveform area: displays the SpO2 waveform. 3. Target parameter statistics area: displays the SpO2 statistics by sections. 4. Parameter trends area: displays trends of the target parameter and secondary
parameters.
5. Other parameter area: displays parameter measurements and alarm limits of parameters other than the target parameter and secondary parameters.
6. Secondary parameters area: displays parameter measurement of PR and PI in big numerics, as well as parameter sources and alarm limits.
15.4.3
Operating the Targeted Goal Screen
You can access parameter setup and trends review from the Targeted Goal screen.
Select the parameter trends area to enter the Tabular Trends review page. Select the target parameter statistics area to enter the parameter statistics setup
menu. Set the range of each section and the target section.
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Select the desired waveform area, parameter numeric area, or dashboard to enter corresponding parameter setup menu.
15.4.3.1 SpO2 Statistics Display
The following figure shows the SpO2 statistics area:
1
2
3
1 Duration of SpO2 statistics 2 Results of SpO2 statistics 3 Sections for statistics: The section in green indicates the target range.
15.4.3.2 Selecting the Range of each SpO2 Section and the Target Section
To define the SpO2 range of each section, follow this procedure:
1. Select the SpO2 statistics area. 2. Select a value on the left of the scale. 3. Use the keyboard on the right to change the value.
4. Drag the section label on the right of the scale up or down to select a target section. The target section is highlighted in green in the SpO2 statistics area.
15.4.3.3
Selecting the SpO2 Statistics Length
The Duration of SpO2 statistics is configurable. From the SpO2 statistics area, select the duration to redefine the length of SpO2 statistics.
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16Recording
16.1
Recorder
The thermal recorder records patient information, measurement data, and up to two waveforms. The monitor can be configured with a built-in recorder.
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2
3 5
4
16.2
1. Start/Stop key: press to start a recording or stop the current recording. 2. Module status indicator
On: when the recorder works correctly. Off: when the monitor is switched off. Flashes: if an error occurred to the recorder. 3. Paper outlet 4. Recorder door 5. Latch: pull it backward to open the recorder door.
Starting Recordings
Recordings can be started manually. In Continuous Monitoring mode, to start a recording, you can either: Press the hardkey on the front of the recorder.
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Select on the current page. In Spot Check mode, to start a recording: 1. Select the Save quick key.
2. Select on the current page.
16.3
Stopping Recordings
Recordings can be stopped manually or automatically.
16.3.1
Stopping Recordings Manually
To manually stop a recording, choose either of the following method:
Press the hardkey again. Select the Main Menu quick key from the Device column select Record Setup,
and then select Clear All Record Tasks.
16.3.2
Stopping Recordings Automatically
Recordings stop automatically in the following conditions: The recording is completed. The recorder runs out of paper. The recorder has an alarm condition.
16.4
Recording Related Flags
You can find the following flags on the recording reports:
For automatically stopped recordings, there are two columns of asterisks "*" at the end of the report.
For manually or abnormally stopped recordings, there is one column of asterisks "*" at the end of the report.
16.5
Setting the Recorder
To set the recorder, follow this procedure: 1. Select the Main Menu quick key from the Device column select Record Setup. 2. In the Record Setup menu, select the desired waveform for Waveform 1 and
Waveform 2 in turn. The recorder can record up to 2 waveforms at a time. 3. Select Recording Duration to set the duration of real-time recording. 4. Select Recorder Paper Speed to set the speed for recording waveforms.
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16.6
Loading Paper
To load paper, follow this procedure:
1. Use the latch at the upper right of the recorder door to pull the door open. 2. Insert a new roll into the compartment as shown below. Feed the paper through
and pull some paper out from the top of the roller. 3. Close the recorder door.
CAUTION
· Use only specified thermal paper. Otherwise, it may cause damage to the
recorder's printhead, the recorder may be unable to print, or poor print
quality may result.
· Never pull the recorder paper with force when a recording is in process.
Otherwise, it may cause damage to the recorder.
· Do not leave the recorder door open unless you reload paper or remove
troubles.
16.7
Removing Paper Jam
If the recorder works incorrectly or produces unusual sounds, check if there is a paper jam first. If a paper jam is detected, follow this procedure to remove it:
1. Open the recorder door. 2. Take out the paper and tear off the draped part. 3. Reload the paper and close the recorder door.
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17Review
17.1
Review Overview
Trends are patient data collected over time and displayed in graphic, tabular, or other forms to give you a picture of how your patient's condition is developing. You can also review the events, scores, and so on.
17.2
Review Page
The Review page contains tabs to display trend data in tabular, graphic, or other forms.
17.2.1 Accessing the Review Page
To enter the review page, select the Review quick key.
17.2.2 Example Review Page
The review pages have similar structure. We take the graphic trends review page as an example.
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12
2
11
3
10
9
8 4
565 7
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1. Record button: select it to output patient information and data through the recorder. 2. Current window time line: indicates the time length of the current window. 3. Waveform area: displays trend curves. The color of trend curves is consistent with
the color of parameter labels. 4. Zoom: select the time duration of data to be viewed on one screen.
5.
or
: goes to the previous or next event.
6.
: displays events in a chronological order. The most recent event is displayed
at the top.The number of asterisk symbols before an event matches alarm priority.
7.
or
: moves the cursor backward or forward
8.
: indicates the position of current window time in the entire time length.
Dragging the slider left or right enables you to locate the trend data at a specific
time and also refreshes data in current window accordingly.
9. Cursor
10. Numeric area: displays numeric values at the cursor indicated time. The background color of numeric values matches the alarm priority.
11. Event area: displays the event of the cursor time. Selecting the event access the event list. If there is no event at the cursor time, the cursor time is displayed.
12. Event type indicator: different color blocks match different types of events: Red: high priority alarm event
Yellow: medium priority alarm event
Cyan: low priority alarm event
White: operation-related event
17.2.3
Reviewing the Tabular Trends
The Tabular Trends review page displays trend data in a tabular form. You can select a patient and trends of a certain period or type to be viewed. Follow this procedure:
1. Select the Review quick key select Tabular Trends tab.
2. Set the filtering condition to PID, Name, or Visit No.. Then select the information of the patient to be viewed.
3. Set Filter to a period of time (30 seconds to 3 hours selectable), a parameter (Temp, Scoring etc.) or type of data (Manually Saved for example).
4. Select a record to be viewed and select Detail to check more information.
17.2.4
Reviewing Scores
The Scoring Review page displays scores in a tabular form. You can select a patient and a certain scoring protocol to be viewed. Follow this procedure:
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1. Select the Review quick key select Scoring Review tab.
2. Set the filtering condition to PID, Name, or Visit No.. Then select the information of the patient to be viewed.
3. Set Filter to MEWS, NEWS or NEWS2. 4. Select a record to be viewed and select Detail to check more information.
17.2.5
Reviewing the Graphics Trends
The Graphic Trends review page displays trend data in a graphic form. To review the Graphic Trends, follow this procedure: 1. Select the Review quick key select Graphic Trends tab. 2. Select Zoom to set the period of data to be displayed on one screen.
3. Move the slider to the left or right to browse more trend data.
17.2.6
Reviewing Events
The monitor stores events in real time, including technical alarm events, physiological alarm events, and operational events. When an event occurs, all the measurement numerics and three event-related waveforms 16 seconds before and after the event is stored.
NOTE
· A total loss of power has no impact on the events stored. · Alarms are saved as events and will be maintained if the equipment is
powered down. The time of equipment power down is not recorded as an
event and cannot be reviewed.
· Earlier events will be overwritten by later ones if the capacity is reached.
17.2.6.1 Viewing the Events Page
To enter the events review page, select Review quick key select Events tab.
The Events page displays event list. Events are displayed in descending chronological order. The most recent event is displayed at the top.The number of asterisk symbols before an event indicate alarm priorities. Different color blocks are displayed on the left of each event to indicate different event types.
Red: high priority alarm event Yellow: medium priority alarm event Cyan: low priority alarm event White: operation-related event
You can view operation events not related to parameters, such as system time change.
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The number of asterisk symbols before and event matches alarm priorities as follows:
***: high priority alarm **: medium priority alarm *: low priority alarm
NOTE
· Pausing or switching off alarms will not be recorded as events. The time of
these operations will not be recorded in the system log.
17.2.6.2 Viewing Event Details
To view waveforms and parameter values at the event time, follow this procedure:
1. Select Review quick key select Events tab.
2. Select an event to be viewed, and then select Detail.
On the Detail page, you can also view the details of other events by either:
selecting
and then the desired event.
selecting
or
to view the previous or next event.
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18User Maintenance Settings
User maintenance enables you to customize your equipment to best meet your needs. Accessing the Maintenance menu is password protected.
This chapter describes the settings and functions in the Maintenance menu.
CAUTION
· The maintenance settings can only be changed by authorized personnel.
Contact your department manager or biomedical engineering department for the passwords used at your facility.
18.1 18.2
Accessing the Maintenance Menu
To perform user maintenance, follow this procedure: 1. Select the Main Menu quick key from the System column select Maintenance
input the required password select . 2. Select desired tab.
The Device Location Settings
Menu Item
Monitor Name Facility Department Room No Bed No Location
Default Setting
/
Function /
Fixed
· Fixed: the Patient Management menu displays Bed No and Room No, but you cannot change them.
· Unfixed: you can change Bed No and Room No from the Patient Management menu.
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Menu Item
Default Setting
Auto Obtain Bed No. Off
Function
The setting is available if Location is set to Unfixed.
NOTE
· If Location is set to Unfixed, Bed No and Room No are cleared each time you
discharge a patient.
18.3 The Patient Management Settings
18.3.1 The Patient Field Tab
Menu Item
Required Optional
Primary Screen Display Full Name Default Admit Patient Method
Patient Verification
Default Setting / Patient ID, Age (GA: Neo) On
ADT Database
Off
Function
Selects which items can be displayed and edited from the Patient Management menu.
Selects whether patient name is displayed in the patient information area on the primary display.
Selects the default list from which to admit a patient. The tab will be displayed after selecting the Patient quick key, if available.
If enabled, only patients from local or ADT database can be admitted.
NOTE
· If the monitor is connected with the CMS, the patient information items and
customized fields are loaded from the CMS.
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18.3.2 The ADT Query Tab
Menu Item ADT Query
Default Setting Function
Patient ID, Patient Name
Selects which criteria can be used to search patients in the ADT server
18.3.3 The Discharge Tab
Menu Item
Default Setting Function
Auto Discharge Patient If Powered Off In Continous Monitoring Mode
Never
Auto Delete Patient Auto Data if Discharged
Clear All Patient
/
Data
Automatically discharges the patient when the monitor is turned off for the designated period of time. Never: not discharge a patient no matter for how long the monitor has been switched off.
Automatically deletes patient data when the patient is discharged.
Deletes all patient information and data. Clearing patient data will discharge the current patient.
18.3.4 The Location Tab
Menu Item
Location 1 Location 10
Default Setting Function
/
Selects where the patient goes after patient
monitoring stops.
18.4 The Authorization Setup Tab
18.4.1 The Clinician Login Tab
Menu Item Clinician Login
Automatic Logout Time Imprivata Domain
Default Setting Function
No Verification 10 min /
Defines whether verification or authentication is required for clinician login.
Sets the time for the monitor to log out the clinician information
Sets the Imprivata domain.
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18.4.2 The Authorization Setup Tab
Section
Menu Item
Default Setting
Maintenance User
Local
Maintenance Password
Clinic
Modify Local Password
Alarm Setup
/
No Password
View Discharged Patients
No Password
Retention Time
20 sec
Function
Selects the password for accessing the monitor's Maintenance menu. · Local Password: the monitor's
password for accessing the Maintenance menu is required.
· Clinician Authentication: the user name and password saved in the MLDAP server are required.
Changes the monitor's password for accessing the Maintenance menu.
Selects the password for changing alarm settings. · No Password: changing alarm settings
is not password protected.
· Local Password: changing alarm switch, alarm limit, and alarm priority is password protected. The monitor's password for changing alarm settings is required.
· Clinician Authentication: changing alarm switch, alarm limit, and alarm priority is password protected. The account and password in the MLDAP are required.
Selects whether password or clinician login is needed to view discharged patients. · No Password: no password is required
to view patient list.
· Clinician Login: patient list can be viewed only after clinician login succeeds.
Selects timeout period of the MLDAP password for accessing the Maintenance menu, alarm settings and arrhythmia settings. If there is no operation after the specified timeout period is reached, you need to re-enter the password.
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Section Clinic
Menu Item
Default Setting
Modify Local / Password
Function
Changes the monitor's password for accessing alarm settings.
18.5 The Save&Send Tab
Section Save Options
Menu Item
Default Setting
Function
Confirm Before Saving On
Selects whether confirmation is needed before saving physiological data.
Clinician And Patient Off info. Required
Send After Saving
Off
Selects whether clinician and patient information is required before saving physiological data.
Selects whether to automatically send the data after saving.
Record After Saving
Off
Log Out After Saving Off
Discharge Patient
On
After Saving
Auto Save After NIBP Off Measurement
Selects whether to automatically start recording after saving.
Selects whether to automatically log out after saving.
Selects whether to automatically discharge the patient after saving in Spot Check mode.
Selects whether to save the data after NIBP measurement is performed.
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Section Send Options
/
Menu Item
Clinician Required
Clinician Match Required
Clear Sent Data After Sending Auto Clear Local Patient List
Default Function Setting
Off
Selects whether clinician login is
needed before sending data.
Off
Selects whether data can be
sent if clinician information does
not match with the information
in database.
Off
Selects whether to clear data
after sending.
Off
Selects whether to clear the
patient information and
physiological data after sending.
18.6 The Alarm Tab
18.6.1 The Audio Tab
Menu Item
Default Setting Function
Minimum Alarm
2
Volume
Alarm Sound
ISO
High Alarm Interval 10 sec Med Alarm Interval 20 sec Low Alarm Interval 20 sec
/
Defines the alarm tone pattern to distinguish the pulse tone and keystroke tone by frequency.
Defines the interval between alarm tones for the ISO mode.
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Menu Item Auto Increase Volume
Increase Volume Delay Defaults
Default Setting Function
2 Steps
20 sec /
· 2 Steps: if an alarm is not reset within the designated delay time after the alarm occurs, the alarm volume automatically increases by two levels.
· 1 Step: if an alarm is not reset within the designated delay time after the alarm occurs, the alarm volume automatically increases by one level.
· Off: if an alarm is not reset within the designated delay time after the alarm occurs, the volume of the alarm tone does not change.
Defines the delay time of alarm volume escalation
Restores default settings on current page.
NOTE
· The alarm volume escalation function is not applied to the latched alarms. · When your monitor is connected to the CMS and Minimum Alarm Volume is
set to 0, Minimum Alarm Volume automatically changes to 2 if the CMS is
disconnected.
18.6.2 The Pause/Reset Tab
Section Pause
Menu Item Pause
Pause Time
Default Setting Function
Alarm Pause
2 min
Selects the pause function. · Alarm Pause: pauses alarms.
· Audio Pause: pauses alarm tones.
Selects the alarm pause time. The alarm pause time can be set to 1 min, 2 min, 3 min, or Permanent.
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Section
Menu Item
Default Function Setting
Pause
Pause Priority All
Alarm Reset
Pause 5 min Pause 10 min Pause 15 min Alarm Light
Off
Off
Off
On When Reset
Reminder Tone
Alarm Reset On Reminder
Alarm Off
On
Reminder
Selects alarms of what priority can be paused. · All: pressing the Alarm Pause quick key
pauses all alarms.
· Med & Low: pressing the Alarm Pause quick key pauses alarms of medium and low priority. The high priority alarms will not be paused.
· Disable: the Alarm Pause quick key is disabled.
Selects how long the alarm can be paused if switched on.
· On When Reset: when the alarm system is reset, the alarm tones of the current alarms are switched off, but the alarm lamp remains flashing.
· Off When Reset: when the alarm system is reset, both the alarm tone and alarm lamp of the current alarms are switched off.
Selects the reminder tone rule when the alarm volume is set to zero, or the alarm is reset or switched off. · On: the monitor issues reminder tones at
a designated interval.
· Re-alarm: if the alarm condition persists the alarms marked with " " will be regenerated after the designated reminder tone interval.
· Off: the monitor does not issue reminder tones at a designated interval. The alarms marked with " " will be silenced.
Selects whether to issue reminder tones when alarm is switched off.
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Section
Reminder Tone
Menu Item
Reminder Interval
Default Function Setting
5 min
· 10 min: the monitor issues reminder tones every 10 minutes.
· 5 min: the monitor issues reminder tones every five minutes.
· 3 min: the monitor issues reminder tones every three minutes.
· 2 min: the monitor issues reminder tones every two minutes.
· 1 min: the monitor issues reminder tones every one minute.
18.6.3 The Latching Tab
Menu Item
Default Setting Function
High, Med, Low
Visible Unselected Audible
Selects alarm latching rules: · If Visible is selected, you can separately
latch visual alarm signal.
· If Audible is selected, you can latch both audible and visual alarm signals.
· Selecting alarms of lower priority simultaneously latches higher priority alarms.
18.6.4 The Nurse Call Tab
Menu Item Default Setting Function
Signal Type Continuous Contact Type Normally Open
· Pulse: the nurse call signal is a pulse signal and each pulse lasts one second. When multiple alarms simultaneously occur, only one pulse signal is outputted. If an alarm occurs but the previous one is not cleared, a new pulse signal will also be outputted.
· Continuous: the nurse call signal lasts until the alarm ends. That is to say the duration of a nurse call signal is equal to that of the alarm condition.
Selects the work mode of the nurse call relay
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Menu Item Default Setting Function
Alarm Priority High Only
Alarm Type
Physiological Only
Selects the priority of alarms sent to the nurse call system
Selects the type of alarms sent to the nurse call system.
18.6.5 The Other Tab
Section
Menu Item
Default Function Setting
Alarm Priority SpO2 Sensor Off CMS/eGW Disconnected
Alarm Delay Alarm Delay
Other
SPO2 Desat Alarm Off
Apnea Alarm Off
Low Low 6 sec
Disable Disable
Selects the alarm level for SpO2 sensor off alarm.
Selects the priority of the CMS and eGateway disconnection alarm. This setting is available only in Continuous Monitoring mode.
· 1 sec - 15 sec for continuously measured parameters, the monitor does not present the alarm if the alarm condition is resolved within the delay time.
· Off: an alarm is always presented.
The setting of Alarm Delay is not applied to the apnea alarms.
Selects whether the SpO2 Desat alarm can be switched off. · Disable: the SpO2 Desat alarm cannot
be switched off.
· Enable: the SpO2 Desat alarm can be switched off.
Selects whether the apnea alarm can be switched off. · Disable: the apnea alarm cannot be
switched off.
· Enable: the apnea alarm can be switched off.
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Section Other
Menu Item
Default Function Setting
CMS/eGW
Off
Disconnected
Alarm
Selects whether an alarm is issued when the monitor is not connected or disconnected from the CMS/eGateway. Off: the "Offline" alarm is not presented when the monitor is not connected or disconnected from the CMS/eGateway.
18.7 The Standby Settings
Menu Item Prompt On Standby Screen Auto Enter Standby
Auto Enter Standby Time Black Screen On Standby
Default Setting Function
/ On
10 min Off
Sets the prompt message to be displayed on the Standby screen.
If enabled, the monitor enters Standby mode automatically if no operation is detected for the time set below.
Sets the time for the monitor to automatically enter Standby mode.
If enabled, the screen turns black after entering Standby mode.
18.8 The CAA Settings
18.8.1 The EWS Tab
Menu Item
Default Adult Score
Default Ped Score
Default Neo Score
Manage Score
Local
USB Drive
Default Setting Function
NEWS2 /
Selects the default scoring tool for different patient category.
/
/
Delete: deletes the selected scoring tools.
The monitor provide MEWS and NEWS by
default. You cannot delete them.
/
Import: imports the desired scoring tools to
the monitor.
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18.8.2 The GCS Tab
Menu Item
Mild Moderate Severe
High Low Color High Low Color High Low Color
Default Setting Function
15 13 White 12 9 Yellow 8 3 Red
Selects the threshold and color of each consciousness level.
18.9 The Module Settings
18.9.1 The NIBP Tab
Menu Item
Default Setting
NIBP Measurement Inflation Algorithm
NIBP Accuracy Test /
NIBP Leakage Test /
Cuff
/
Function
Selects the algorithm for NIBP measurement. · Inflation: The monitor performs NIBP
measurement during cuff inflation. If measurement fails, it will continue the measurement in deflation stage. This algorithm is applicable only for adult patients. · Deflation: The monitor performs NIBP measurement during cuff deflation.
To perform a NIBP accuracy test.
To perform a NIBP leakage test.
Shows the cuff pressure during NIBP accuracy and leakage tests.
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Menu Item Orthostatic BP Symptoms
Add Criterion
Default Setting
Dizziness/Visual Disturbance/ LightHeadedness/ Feeling of Weakness/ Vagueness/ Palpitation/Pallor
Add Symptom
/
Function Edits the provided symptoms. Available only when the monitor is in Spot Check mode.
To add new symptoms. Available only when the monitor is in Spot Check mode. Sets the evaluation criterion for orthostatic BP results. Available only when the monitor is in Spot Check mode.
18.9.2 The CO2 Tab
Menu Item
Default Setting Function
CO2(%)
5.0
Zero Recovery For 30s On
Zero
/
Defaults
/
Sets the concentration of calibration gas. A range of 3.0 to 7.0 is selectable. Click Calibrate to start CO2 calibration.
On: After the zero calibration is completed, the CO2 module reacquires the CO2 readings. During the reacquisition period, "Zero Recovering" is displayed in the CO2 numeric area. Off: After the zero calibration is completed, the CO2 module reacquires the CO2 readings. During the reacquisition period, "Zero Recovering" is not displayed in the CO2 numeric area.
Select this button to start zeroing the CO2 module.
Restores default CO2 settings.
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18.9.3 The Temp Tab
Menu Item Temp Temp Measurement Site
Default Setting Function
/
Ear/Temporal / Oral/Axillary
Selects the type of Temp module.
Sets the options displayed in the Measurement Site menu.
18.9.4
The Manual Input Tab
This menu lists the manual parameters currently supported on the monitor. You can also add other parameters to the list. For details, refer to 14.4.2 Adding a New Parameter.
18.9.5 The Pain Score Tab
Menu Item Pain Score Method
Custom Pain Score Method Add Description
Default Setting Function
VAS-cm/VASmm/NRS/VRS-5/ FPS-R/FLACC
Enables or disables the pain scales.
Custom 1/ Custom 2
Sets custom pain scales and selects whether to display them.
/
Adds descriptions for pain assessment.
18.9.6 The Other Tab
Menu Item NIBP Timeout Temp Timeout Outline Font for Suspected Values
SpO2 Calc RR
Default Setting Function
15 min 30 min On
On
Sets the time for a NIBP value to be displayed as outlined.
Sets the time for a Temp value to be displayed as outlined.
Selects whether unreliable SpO2 measurements are displayed in outline font. This prevents unreliable measurements from being misinterpreted as normal measurements.
If enabled, the RR value can be sourced from SpO2. This function requires a license.
18 - 14
18.10 The Unit Settings
Menu Item Height Unit Weight Unit Glucose Unit I/O Fluid Unit CO2 Unit Temp Unit Pressure Unit
Default Setting cm kg mg/dl ml mmHg °C mmHg
Description
Selects measurement unit for each parameter.
18.11 The Time Settings
18.11.1 The Time Synchronization Tab
Section / NTP Server
Menu Item
Time Zone Start NTP Time Sync
Default Setting
Off
Interval
1 hr
Time Server Address
Time Server
Connection Status
Network Test
0.0.0.0 / / /
Description
Selects the current time zone.
On: enables synchronizing the monitor time with the NTP server time.
Select the time interval for synchronizing the monitor time with the NTP server time.
The domain name of the time server.
The IP address of the time server.
Shows the status of connection with the NTP server.
Tests whether the NTP server is properly connected.
18 - 15
18.11.2 The Daylight Savings Time Tab
Section
Default Setting
Auto Daylight Savings Time Off
Description On: auto starts the daylight savings time.
18.12 The Version Tab
Tab Version
Default Setting Function
/
Displays system software version, module hardware
and software version, and firmware version.
18.13 The Battery Information Settings
Tab Battery1 Battery2
Default Setting Function
/
Displays battery information.
/
18.14 The Scanner Settings
18.14.1 The Scanner Info. Tab
Section /
Default Menu Item Setting
Data Parse Mode
Data Encoding Type
JADAK UTF8
Description
Sets the data parse mode. JADAK, Local, and DLL are selectable.
Sets the data encoding type. Keyboard Code, UTF8, and Unicode are selectable.
18 - 16
Section Patient Barcode
Clinician Barcode
Menu Item Default Setting
Prefix
/
Postfix
/
Remove
Off
Prefix/Suffix
Content Fill Patient ID to
Prefix
/
Postfix
/
Remove
Off
Prefix/Suffix
Description
Sets the prefix for patient barcode. Sets the postfix for patient barcode. Sets whether to remove the set prefix or postfix. Selects a destination to fill the scanned information. Sets the prefix for clinician barcode. Sets the postfix for clinician barcode. Sets whether to remove the set prefix or postfix.
18.14.2 The JADAK Barcode Tab
Menu Item Patient Category Gender Age Month
Default Setting Function
/
Sets the information of JADAK
barcode. /
/
/
18.14.3 The Identify Scanner Tab (for the non-Mindray Custom 2D Barcode Reader)
Tab Identify Scanner
Default Setting Function
/
When you are using barcode readers other
than HS-1R or HS-1M, you should select the
barcode reader from the USB device list, so that
the monitor can identify the barcode reader.
From the USB device list, select the barcode
reader you are using.
18 - 17
18.14.4 The Field Tab (for the Mindray Custom 2D Barcode Reader)
Menu Item
Default Setting Function
Patient ID/First Name/Last Name/ Patient Category/Gender/DOB
Visit Number/Room No/Bed No/ Age/Department/Custom Field 1 Custom Field 4
Selected Unselected
Selects desired patient information to be output by the barcode reader.
18.15 The Record Settings
Tab
Default Setting
Function
Report Layout
Patient Name/Patient ID/Patient Category/ Visit Number/Gender/ Bed No/DOB/Room No
Sets the information to be included in the reports, and positions of the information
18.16 The Network Setup Settings
18.16.1 The Network Type Tab
Menu Item Default Setting
Function
Monitor
Auto (if WLAN is available on your monitor) LAN1 IP (if WLAN is not available on your monitor)
Selects the type of network to be used. Auto: the monitor automatically identify your network type.
18.16.2 The LAN1 IP Tab
Menu Item
Default Setting Function
Obtain IP Address Automatically
On
Use the Following Address
Off
Obtain DNS address automatically On
Automatically gets the IP address.
IP Address, Subnet Mask, and Gateway are required.
Automatically gets the DNS address
18 - 18
Menu Item Using the Following DNS Address
Default Setting Function
Off
IP addresses of Preferred DNS
Server and Alternate DNS
Server are required.
18.16.3 The WLAN Tab
Menu Item
Default Setting
Function
Available Network List
/
Add WLAN
WLAN
/
WLAN IP
/
WLAN WLAN Band Setup
Auto
2.4G Channel All
5G Channel All
Certificate
Local
/
Management
USB Drive
/
Lists the available network currently detected.
Sets the Name, SSID, Security Method, and Password of the wireless network.
See 18.16.4 The WLAN IP Tab.
Auto: automatically identifies the WLAN band.
Selects the type of 2.4G channels.
Selects the type of 5G channels.
Delete: delete the selected certifications.
Select certifications you want to import from the USB memory, and then select Import: import the desired certifications from the USB memory.
18.16.4 The WLAN IP Tab
Menu Item
Obtain IP Address Automatically
Use the Following Address
Default Setting Function
On
Selects whether to enable the function of
automatically getting the IP address.
Off
Selects whether inputting the IP Address,
Subnet Mask, and Gateway is required.
18 - 19
Menu Item
Default Setting Function
Obtain DNS address On automatically
Using the Following Off DNS Address
Selects whether to enable the function of automatically getting the DNS address.
Selects whether inputting the IP address of Preferred DNS Server and Alternate DNS Server is required.
18.16.5 The Transfer Setup Tab
Menu Item
/
Send Data
Central Station Setup
Select CMS
Add Central Station
eGate way Setup
Server Address IP Address Network Test
Data + Wavef orms
Server Address Destination IP
Port Send Data Send Waveforms Data Interval Connection Status
Default Setting Function
Central Station
On
/
/ 0.0.0.0 /
/ 0.0.0.0 0 Off Off
Selects a destination to send selected data.
Selects whether to enable the CMS selection function for your monitor.
Inputs the name, department, and server address of the CMS. You can add up to 30 CMSs for monitor.
Input the server address or IP address of eGateway.
Tests whether the eGateway server is properly connected.
Inputs the name or IP address for the server receiving the realtime data and waveform.
/
30 sec Disconnected
18 - 20
Menu Item
Default Setting Function
Alarms Server Address Destination IP
/ 0.0.0.0
Inputs the name or IP address for the server receiving the alarm data.
Port
0
/
Send Alarms
Off
Connection Status
Disconnected
Data + Waveforms and Alarms are for HL7 setup. You can send the realtime data, waveforms, and alarms from the monitor to the hospital servers via HL7 protocol.
ADT
Server Address 192.168.0.100 Input the host name or IP address of
IP Address
192.168.0.100
the ADT gateway.
Port
3502
Input the port of the ADT gateway.
ADT Query
Off
Selects whether patient information can be loaded to the monitor from the ADT server.
Network Test
/
Tests whether the ADT server is properly connected.
The ADT (admit-discharge-transfer) gateway is normally deployed in the eGateway. You can obtain patient information from the hospital ADT server through the ADT gateway.
18.16.6 The Device Discover Tab
Multicast helps device discovery between monitors and between monitors and CMS. Devices in the same multicast group can be mutually discovered.
Menu Item
Multicast TTL Multicast Address Master Server Address Master Server IP Address Connected Status
Default Setting 1 225.0.0.8 /
0.0.0.0
Disconnected
Function /
/
18 - 21
Menu Item Network Test
Default Setting /
Function
Tests whether the master server is properly connected.
18.16.7 The QoS Tab
S
Menu Item
QoS Level For Realtime Monitoring
Default Setting
0
QoS Level For
0
Others
Function
Selects the service quality of network connection for realtime monitoring, for example parameter measurements and waveforms, alarms, and so on
Selects the service quality of network connection for non-realtime monitoring, for example history data, printing, and as on.
18.16.8 The MLDAP Tab
Menu Item
Default Setting
Server Address IP Address Port Network Test
/ 0.0.0.0 6665 /
Function
Inputs the name or IP address for the MLDAP server.
/ Tests whether the monitor is properly connected with the MLDAP server.
18.16.9 The VitalsLink Tab
Section /
Menu Item Enable
Automatically Logout after
Default Setting
Description
Off 10 min
Selects whether to enable VitalsLink connection. This function requires a license.
Sets the time to log out automatically.
18 - 22
Section
Menu Item
General Connectivity
Master Server Address
Context Root
Organization ID
Local CSI
Security
Auth Type
User Name
User Password
Tenant Type
Tenant Value
Transport Protocol
Barcode Format Configuration
Data Encoding Type
Import Aliases
Import Bearer
Import Certificate
Import CSI
Default Setting /
/ / Off Basic / / None / HTTP UTF8
/ / / /
Description Sets the connection information.
Sets the security information.
Sets the data encoding type. To import Aliases. To import Bearer. To import certificate. To import CSI.
18.17 The Bluetooth Tab
Menu Item Enable
Default Setting Off
Auto Unpair On 10 minNone Disconnection
Paired Device /
Function
· On: the bluetooth function is enabled, and the monitor can be found by other bluetooth devices.
· Off: the bluetooth function is disabled.
Sets the time of unpairing after the monitor and bluetooth device being connected.
Lists the devices that has paired with the monitor.
18 - 23
18.18 The Other Tab
Menu Item Barometric Pressure SpO2 Tone
Clear CMS IP at startup Language Parameter Output Setup
Export Patient Data Browse System Log Export System Log Modify Password
Default Setting Function
760 mmHg Mode 1
On / /
/ / / /
Sets the barometric pressure.
Selects the SpO2 tone. The same SpO2 tone mode should be used for monitors in the same area.
/
/
Configures DIAP protocol parameters to realize communications between the monitor and third party devices.
To export the patient data to a USB drive.
To browse the system log.
To export the system log to a USB drive.
To modify maintenance password.
18 - 24
19Battery
19.1 19.2
Overview
This monitor is designed to operate on battery power when the mains power is not available. The monitor uses mains power as primary power source. In case of mains power failure, the monitor automatically runs on the battery power.
Battery Safety Information
WARNING
· Keep batteries out of children's reach. · Use only specified battery. Use of a different battery may present a risk of fire
or explosion.
· Keep the batteries in their original package until you are ready to use them. · Do not expose batteries to liquid. · Do not crush, drop or puncture the battery. Mechanical abuse can lead to
internal damage and internal short circuits. If a battery has been dropped or
banged against a hard surface, whether damage is externally visible or not,
remove the battery from use and dispose of it properly.
· If the battery shows signs of damage or signs of leakage, replace it
immediately.
· The battery should be charged only in this monitor. · Extremely high ambient temperature may cause battery overheat
protection, resulting in monitor shutdown.
· The lithium-ion battery has a service life of three years. Replace your battery
when it reaches the end of its service life. Failure to replace the battery may
cause serious damage to your equipment from battery overheating.
· Do not open batteries, heat batteries above 60 °C, incinerate batteries, or
short battery terminals. They may ignite, explode, leak or heat up, causing
personal injury.
CAUTION
19 - 1
· Remove the battery before shipping the monitor or if it will not be used for
an extended period of time.
NOTE
· It is recommended to always install a fully charged battery in the monitor to
ensure normal monitoring in case of accidental power failure.
19.3
Battery Indications
The battery LED, on-screen battery symbols, and related alarm messages indicate the battery status.
19.3.1
Battery LED
The battery LED is on the left bottom of the front panel of the monitor. For details, see 2.7.1 Front View (VS 9 Series) and 2.7.2 Front View (VS 8 Series).
19.3.2
Battery Symbols
The on-screen battery symbols indicate the battery status as follows:
For VS 9 series:
7.1h indicates that the battery power is sufficient. The green portion represents the remaining charge and the numerics in the middle indicates the estimated run time of the battery.
0.5h indicates that the battery power is low and needs to be charged. The red portion represents the remaining charge and the numerics in the middle indicates the estimated run time of the battery.
indicates that the battery is almost depleted and needs to be
charged immediately. Otherwise, the monitor will soon automatically shut
down.
indicates that no battery is installed or the battery fails.
7.8h indicates that the battery is being charged. An extra lightning symbol is displayed and the green portion is animated. When a battery is
charged on a new monitor for the first time, the estimated run time will not be displayed. Instead, a percentage indicating the current charge is displayed on the right of the battery symbol.
For VS 8 series:
indicates that the battery power is sufficient. The green portion
represents the remaining charge.
indicates that the battery power is low and needs to be charged. The
red portion represents the remaining charge.
19 - 2
indicates that the battery is almost depleted and needs to be
charged immediately. Otherwise, the monitor will soon automatically shut
down.
indicates that no battery is installed or the battery fails.
indicates that the battery is being charged. An extra lightning
symbol is displayed and the green portion is animated.
CAUTION
· The numerics on the battery symbol are estimated remaining battery run
time. The accuracy of the remaining time is greatly affected by the working condition of the monitor and status of the battery. Do not rely exclusively on this for operation time estimation in clinical applications.
19.3.3 Battery-related Alarms
Refer to D.2.7 Power Supply Technical Alarm Messages.
19.4
Replacing the Battery (for VS 9 Series)
For VS 9 series, to replace the battery, follow this procedure: 1. Turn off the monitor. Disconnect the power cable and other cables. 2. Lay the monitor down to expose the bottom of the monitor. 3. Open the battery compartment door.
4. Turn the latch aside. 5. Take out the old battery. Then insert the new battery into the battery compart-
ment with the battery terminal inwards. 6. Turn the latch back to the middle and close the battery door.
19 - 3
19.5
Replacing the Battery (For VS 8 Series)
For VS 8 series, to replace the battery, follow this procedure: 1. Turn off the monitor. Disconnect the power cable and other cables. 2. Lay the monitor down to expose the bottom of the monitor. 3. Open the battery compartment door.
4. Disconnect the old battery from the connectors on the left of the battery compartment and take out the old battery.
5. If a 2500 mAh battery is used, put a battery support into the battery compartment. If a 5000 mAh battery is used, the support is not needed.
6. Insert the new battery into the battery compartment with the battery terminal outwards. Then connect the battery to the connectors on the left of the battery compartment.
7. Close the battery door.
19 - 4
19.6
Connecting an External Battery
You can connect an external battery to the monitor via the connector on the back.
VS 9 Series
VS 8 Series
Connector for an External Battery
The external battery is charged whenever the monitor is connected to an AC power source regardless of whether or not the monitor is currently on.
19.7
Charging a Battery
The battery is charged whenever the monitor is connected to an AC power source regardless of whether or not the monitor is currently on. When battery is charging, the AC power indicator and battery indicator are both on.
19.8
19.8.1
Maintaining the Battery
Conditioning the Battery
The performance of a rechargeable battery deteriorates over time. You should condition the batteries every three months.
If the battery is not conditioned for a prolonged time, its charge indication may not be accurate and you may wrongly evaluate the remaining battery runtime.
To condition a battery, follow this procedure:
1. Disconnect the monitor from the patient and stop all monitoring and measuring procedures.
2. Turn the monitor off. Install the battery to be conditioned.
3. Connect the monitor to AC power. Allow the battery to be charged uninterrupted till it is fully charged.
4. Remove AC power and allow the monitor to run from the battery until it shuts off.
19 - 5
5. Connect the monitor to AC power. Fully charge the battery again for use or charge it to 40 60% for storage.
NOTE
· Do not use the monitor to monitor the patient during battery conditioning. · Do not interrupt battery conditioning.
19.8.2
Checking Battery Performance
Life expectancy of a battery depends on how frequent and how long it is used. For a properly maintained and stored lithium ion battery, its life expectancy is about 3 years. For more aggressive use models, life expectancy can be less. We recommend replacing lithium ion batteries every 3 years.
You should check the battery performance every three months or if you doubt that the battery may fail.
See steps 1 to 5 of 19.8.1 Conditioning the Battery to check battery performance. The operating time of the battery reflects their performance directly. If the operating time of a battery is noticeably shorter than that stated in the specifications, the battery may reach its service life or malfunction. If the battery performance meets the requirement, fully charge the battery again for use or charge it to 40 60% for storage.
NOTE
· Battery operating time depends on equipment configuration and operation.
For example, high display brightness or measuring NIBP repeatedly will
shorten the battery operating time.
19.9
Storing Batteries
When storing batteries, make sure that the battery terminals do not come into contact with metallic objects. If batteries are stored for an extended period of time, place the batteries in a cool place with a partial charge of 40% to 60% capacity.
Condition the stored batteries every three months. For more information, see 19.8.1 Conditioning the Battery.
NOTE
· Remove the battery from the equipment if the equipment is not used for a
prolonged time (for example, several weeks). Otherwise the battery may overdischarge.
· Storing batteries at high temperature for an extended period of time will
significantly shorten their life expectancy.
19 - 6
· Storing batteries in a cool place can slow the aging process. Ideally the
batteries should be stored at 15 °C.
19.10 Recycling Batteries
Discard a battery in the following situations: The battery has visual signs of damage. The battery fails. The battery is aged and its runtime significantly less than the specification. The battery service life is reached. Properly dispose of batteries according to local regulations.
WARNING
· Do not open batteries, heat batteries above 60 °C, incinerate batteries, or
short the battery terminals. They may ignite, explode, leak or heat up, causing personal injury.
19 - 7
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19 - 8
20 Care and Cleaning
20.1 20.2
Care and Cleaning Introduction
In this chapter we only describe cleaning and disinfection of the monitor (not including the cradle of Convidien GeniusTM 3tethered tympanic thermometer), and certain accessories. For the cleaning and disinfection of the other reusable parameter accessories, refer to their instructions for use.
Care and Cleaning Safety Information
WARNING
· Use only Mindray approved cleaners, disinfectants and methods listed in this
chapter to clean or disinfect your equipment or accessories. Warranty does
not cover damage caused by unapproved substances or methods.
· Do not mix disinfecting solutions, as hazardous gases may result. · We make no claims regarding the efficacy of the listed chemicals or methods
as a means for controlling infection. For the method to control infection,
consult your hospital's infection control officer or epidemiologist.
· Be sure to turn off the system and disconnect all power cables from the
outlets before cleaning the equipment.
· The responsible hospital or institution shall carry out all cleaning and
disinfection procedures specified in this chapter.
CAUTION
· Never immerse any part of the equipment or accessories in liquids or allow
liquid to enter the interior.
· Any contact of cleaners or disinfectants with connectors or metal parts may
cause corrosion.
· Do not pour or spray any liquid directly on the equipment or accessories or
permit fluid to seep into connections or openings.
· If you spill liquid on the equipment or accessories, disconnect the power
supply, dry the equipment, and contact your service personnel.
· Never use abrasive materials (such as steel wool or silver polish), or erosive
cleaners (such as acetone or acetone-based cleaners).
20 - 1
· Dilute and use the cleaners or disinfectants according to the manufacturer's
instructions.
· Check the equipment after cleaning and disinfecting. If there is any sign of
damage, remove it from use.
20.3 Cleaning and Disinfecting the Main Unit
20.3.1
Cleaning the Main Unit
Clean the monitor on a regular basis. Before cleaning, consult your hospital's regulations.
To clean the monitor, follow this procedure:
1. Dampen a soft lint-free cloth with water or ethanol (70%). 2. Wring excess liquid from the cloth. 3. Wipe the display screen of the monitor. 4. Wipe the external surface of the main unit with the damp cloth, avoiding the
connectors and metal parts. 5. Dry the surface with a clean cloth. Allow the equipment and mounting kits air dry
in a ventilated and cool place.
CAUTION
· During the cleaning procedure, disable the touch operation by switching off
the monitor or locking the touchscreen.
· Any contact of cleaners or disinfectants with connectors or metal parts may
cause corrosion.
20.3.2
Disinfecting the Main Unit
Disinfect the monitor as required in your hospital's servicing schedule. Cleaning the monitor before disinfecting is recommended. Always dilute and use disinfectants according to the manufacturer's instructions.
20.3.3 Approved Cleaning and Disinfecting Agents for Main Unit
The following table lists approved cleaning and disinfecting agents:
Product Name
Alpet® D2 Surface Sanitizing Wipes
Product Type Manufacturer
Wipes
BEST SANITIZERS INCTM.
20 - 2
Product Name
Clorox Dispatch® Hospital Cleaner Disinfectant Towels with Bleach
Clorox Healthcare® Bleach Germicidal Wipes
Clorox Healthcare® Hydrogen Peroxide Cleaner Disinfectant Wipes
Diversey Oxivir® TB Wipes
Metrex CaviCide1TM
Metrex CaviWipesTM
PDI Sani-Cloth® AF3 Germicidal Disposable Wipe
PDI Sani-Cloth® Bleach Germicidal Disposable Wipe
PDI Sani-Cloth® HB Germicidal Disposable Wipe
PDI Sani-Cloth® Plus Germicidal Disposable Cloth
PDI Super Sani-Cloth® Germicidal Disposable Wipe
Virex® II 256 (1:256)
Virex® TB
HEALTH ESSENCE Disinfecting Effervescent Tablets
HEALTH ESSENCE Surface Disinfectant
Health Essence Bis-QACs Disinfectant
DIAN'ERKANG® Surface Wipes
DIAN'ERKANG® Surface Disinfectant
Product Type Manufacturer
Wipes
Clorox professional products company
Wipes Wipes
Clorox professional products company
Clorox professional products company
Wipes Liquid, spray Wipes Wipes
Diversey Inc METERX® RESEARCH METERX® RESEARCH PDI Inc.
Wipes
PDI Inc.
Wipes
PDI Inc.
Wipes
PDI Inc.
Wipes
PDI Inc.
Liquid Liquid, spray Tablets Liquid, spray Liquid Wipes Liquid
Diversey Inc
Diversey Inc
Beijing ChangJiangMai Medical Science Technology Co. Ltd.
Beijing ChangJiangMai Medical Science Technology Co. Ltd.
Beijing ChangJiangMai Medical Science Technology Co. Ltd.
Shanghai Likang Disinfectant HiTech Co., Ltd.
Shanghai Likang Disinfectant HiTech Co., Ltd.
20 - 3
Product Name
DIAN'ERKANG® Disinfection Spray Clinell® Universal Wipes Clinell ® Sporicidal Wipes Tristel DuoTM Tristel Jet Tristel Fuse For Surfaces, 196ppm Surfanios Premium, 0.25% Surfa 'safe Wip' Anios EXCEL Aniosurf ND premium, 0.25% Mikrobac® Tissues Cleanisept® Wipes mikrozid® PAA Wipes mikrozid® Sensitive Wipes Ecolab Incidin® OxyWipe S. Glutaraldehyde, 2%
Ethanol, 70%
Isopropanol, 70%
*Sodium hypochlorite bleach, 0.5%
Hydrogen peroxide, 3%
Rely+OnTM Virkon® High Level surface Disinfectant, 1%
1-Propanol, 50%
Product Type Manufacturer
Liquid, spray Wipes
Shanghai Likang Disinfectant HiTech Co., Ltd.
GAMA Healthcare Ltd
Wipes
GAMA Healthcare Ltd
Liquid, spray Liquid, spray Liquid
Tristel solutions Limited Tristel solutions Limited Tristel solutions Limited
Liquid Liquid, spray Wipes Liquid Wipes Wipes Wipes Wipes Wipes Liquid Liquid Liquid Liquid
ANIOS LABORATORIES ANIOS LABORATORIES ANIOS LABORATORIES ANIOS LABORATORIES BODE Chemie GmbH Dr. Schumacher GmbH Schülke & Mayr GmbH Schülke & Mayr GmbH Ecolab Deutschland GmbH / / / /
Liquid Powder
/ Antec International Ltd
Liquid
/
20 - 4
Product Name
Product Type Manufacturer
Descosept® forte
Liquid
Descosept® AF
Liquid
Dismozon® plus, 0.4%
Powder
mikrozid® AF Wipes
Wipes
Terralin® Liquid
Liquid
Perform® Classic Concentrate OXY, 0.5%
Powder
S-7 hospital grade disinfectant Wipes surface wipes
Neutral detergent wipes
Wipes
Premier disinfectant wips
Wipes
V-wipes
Wipes
Dr. Schumacher GmbH Dr. Schumacher GmbH BODE Chemie GmbH Schülke & Mayr GmbH Schülke & Mayr GmbH Schülke & Mayr GmbH
ANAERON
RAYNARD Health RAYNARD Health Whiteley Medical
20.4
Cleaning and Disinfecting the Accessories
For the NIBP air hose and SpO2 cable, you should clean and disinfect them using the cleaners and disinfectants and methods listed in this section. For other accessories, you should consult the instructions delivered with the accessories.
CAUTION
· Fluids entering the NIBP air hose can damage the equipment. When cleaning
or disinfecting the NIBP air hose, prevent liquid from entering the hose.
· Periodically inspect the NIBP air hose and connector for signs of wear or
deterioration after cleaning or disinfecting the NIBP air hose. Replace the
NIBP air hose if you detect a leak. Dispose of damaged NIBP air hose
according to local laws for disposal of hospital waster.
· Never immerse or soak the accessories in any liquid. · Never clean or disinfect the connectors and metal parts. · Use only Mindray approved cleaners and disinfectants and methods listed in
this section to clean or disinfect the accessories. Warranty does not cover
damage caused by unapproved substances or methods.
· To avoid long term damage, the accessories should be disinfected only when
necessary as determined by your hospital's policy.
20 - 5
20.4.1
Cleaning and Disinfecting Agents for the NIBP Air Hose
The following table lists approved cleaning and disinfecting agents for the NIBP air hoses:
Product Name
Product Type Manufacturer
Alpet® D2 Surface Sanitizing Wipes
CIDEXR OPA
Wipes Liquid
Clorox Dispatch® Hospital Cleaner Disinfectant Towels with Bleach
Wipes
Metrex CaviCide1TM
Liquid, spray
Metrex CaviWipesTM
Wipes
PDI Sani-Cloth® AF3 Germicidal Disposable Wipe
Wipes
PDI Sani-Cloth® Plus Germicidal Disposable Wipe
Wipes
PDI Super Sani-Cloth® Germicidal Disposable Wipe
Wipes
Virex® TB
Liquid, spray
Clinell® Universal Wipes
Wipes
Surfa 'safe
Liquid, spray
Aniosurf ND premium, 0.25%
Liquid
mikrozid® Tissues
Wipes
Glutaraldehyde, 2%
Liquid
Ethanol, 70%
Liquid
Isopropanol, 70%
Liquid
Rely+OnTM Virkon® High Level surface Disinfectant, 1%
Powder
1-Propanol, 50%
Liquid
BEST SANITIZERS INCTM.
Gilag GmbH International Advanced Sterilization products Clorox professional products company
METERX® RESEARCH METERX® RESEARCH PDI Inc.
PDI Inc.
PDI Inc.
Diversey Inc GAMA Healthcare Ltd
ANIOS LABORATORIES ANIOS LABORATORIES Schülke & Mayr GmbH
/ / / Antec International Ltd
/
20 - 6
20.4.2
Cleaning and Disinfecting Agents for the SpO2 Cable
The following table lists approved cleaning and disinfecting agents for the Masimo cables:
Product Name
Product Type Manufacturer
Isopropanol, 70%
Liquid
/
The following table lists approved disinfectants for the Nellcor SpO2 cables:
Product Name
Product Type Manufacturer
CIDEXR OPA
Liquid
Clorox Dispatch® Hospital Cleaner Disinfectant Towels with Bleach
Wipes
Clorox Healthcare® Bleach Germicidal Wipes
Wipes
Clorox Healthcare® Hydrogen Peroxide Cleaner Disinfectant Wipes
Wipes
Diversey Oxivir® TB Wipes
Wipes
PDI Super Sani-Cloth® Germicidal Disposable Wipe
Wipes
Virex® TB
Liquid, spray
Glutaraldehyde, 2%
Liquid
Ethanol, 70%
Liquid
Isopropanol, 70%
Liquid
Sodium hypochlorite bleach, 0.5% Liquid
Hydrogen peroxide, 3%
Liquid
Rely+OnTM Virkon®
Powder
High Level surface Disinfectant, 1%
1-Propanol, 50%
Liquid
Gilag GmbH International Advanced Sterilization products Clorox professional products company
Clorox professional products company Clorox professional products company
Diversey Inc
PDI Inc.
Diversey Inc / / / / / Antec International Ltd
/
20 - 7
20.4.3
Cleaning the Accessories
You should clean the accessories (NIBP air hose, and SpO2 cable) on a regular basis. Before cleaning the accessories, consult your hospital's regulations for cleaning the accessories.
To clean the accessories (NIBP air hose and SpO2 cable), follow this procedure:
1. Clean the accessories with a soft cloth moistened with water or ethanol (70%).
2. Wipe off all the cleaner residue with a dry cloth.
3. Allow the accessories to air dry.
20.4.4
Disinfecting the Accessories
We recommend that the accessories (NIBP air hose and SpO2 cable) should be disinfected only when necessary as determined by your hospital's policy. Cleaning the accessories before disinfecting is recommended.
20.5
Sterilization
Sterilization is not recommended for this monitor, related products, accessories, or supplies unless otherwise indicated in the Instructions for Use that accompany the products, accessories or supplies.
20.6
Impact of Improper Cleaning
Using cleaners other than those recommended may have the following impact: Product discoloration Metal part corrosion Brittle and breaking wires, connectors, and equipment housing Reduced cable and leadwire life Overall system performance degradation Equipment malfunction or failure
20 - 8
21Maintenance
21.1 21.2
Maintenance Introduction
Regular maintenance is essential to ensure that the equipment functions properly. This chapter contains information on periodic testing and maintenance.
Maintenance Safety Information
WARNING
· To avoid electric shock, stop using the monitor if you find the housing of the
monitor has signs of broken. Contact the service personnel for help in that
case.
· Failure on the part of the responsible individual hospital or institution using
this equipment to implement a recommended maintenance schedule may
cause undue equipment failure and possible health hazards.
· No modification of this equipment is allowed. · This equipment contains no user serviceable parts. · Do not open the equipment housings. All servicing and future upgrades must
be carried out by the service personnel.
· The safety checks or maintenance involving any disassembly of the
equipment should be performed by professional service personnel.
Otherwise, undue equipment failure and possible health hazards could
result.
· Do not open batteries, heat batteries to above 60 °C, incinerate batteries, or
short the battery terminals. Batteries may ignite, explode, leak or heat up,
causing personal injury.
· Do not adjust, repair, open, disassemble, or modify the pulse oximeter or
accessories. Injury to personnel or equipment damage could occur. Return
the pulse oximeter for servicing if necessary.
· The service personnel must be properly qualified and thoroughly familiar
with the operation of the equipment.
21 - 1
CAUTION
· The equipment and accessories shall not be served or maintained while in
use with a patient.
· If you discover a problem with any of the equipment, contact your service
personnel or Mindray.
· Use and store the equipment within the specified temperature, humidity, and
altitude ranges.
· When disposing of the packaging material, be sure to observe the applicable
waste control regulations and keep it out of children's reach.
· At the end of its service life, the equipment, as well as its accessories, must be
disposed of in compliance with the guidelines regulating the disposal of such products. If you have any questions concerning disposal of the equipment, please contact Mindray.
NOTE
· If needed, contact the manufacture for circuit diagrams, component part
lists, descriptions, calibration instructions, or other information concerning the repair of the equipment.
21.3
Maintenance and Testing Schedule
Follow the maintenance and testing schedule or local regulations to perform testing and maintenance. Make sure to clean and disinfect the equipment before taking any tests and maintenance
The following table lists the maintenance and testing schedule:
Test/Maintenance Item
Performance Tests
Visual inspection Measurement module performance test and calibration
Recommended Frequency
Every day, before first use.
1. If you suspect that the measurement values are incorrect. 2. Follow any repairs or replacement of relevant module. 3. Once a year for CO2 tests. 4. Once every two years for other parameter module performance tests.
21 - 2
Test/Maintenance Item Performance Tests Nurse call test
Electrical Safety Tests Electrical safety tests Other Tests Power-on test Recorder check
Battery check
Functionality test
Performance test
Recommended Frequency
If you suspect that the nurse call function does not work properly.
Once every two years.
Before use. 1. When the recorder is used for the first time. 2. Follow any repair or replacement of the recorder. 1. When first installed. 2. When battery is replaced. Every three months or if the battery runtime reduced significantly.
21.4 21.5
Checking Version Information
You may be asked for information on monitor and module version. To view system software version information, select the Main Menu quick key from the System column select Version.
You can also view more version information by following this procedure 1. Select the Main Menu quick key from the System column select Maintenance
input the required password select . 2. Select the Version tab. You can check system software version, module hardware and software version, and firmware version.
Testing Methods and Procedures
Except the following maintenance tasks, all other test and maintenance tasks should be performed by Mindray-qualified service personnel only. Regular check, including visual inspection and power-on test Recorder test Battery check
21 - 3
If your monitor needs a safety test and performance test, contact the service personnel.
21.5.1
Performing Visual Inspection
Visually inspect the equipment before its first used every day. If you find any signs of damage, remove your monitor from use and contact the service personnel.
Verify that the equipment meets the following requirements: Environment and power supply specifications are met. The monitor housing and display screen are free from cracks or other damages The power cord is not damaged and the insulation is in good condition. Connectors, plugs, and cables are not damaged and kinked. Power cord and patient cables are securely connected with the equipment.
21.5.2
Performing Power-on Test
The monitor automatically performs a selftest at startup. Check the following items for the power-on test:
The equipment powers on properly. The alarm system works properly. The monitor displays properly.
21.5.3
Testing the Recorder
To test the recorder, follow this procedure: 1. Start a recording task to print waveforms and reports. 2. Check that the recorder functions correctly. 3. Check that the printout is clear without missing dots.
21.5.4 Checking the Battery
For information on battery check, see 19.8.2 Checking Battery Performance.
21.6
Disposing of the Monitor
Dispose of the monitor and its accessories when its service life is reached. Follow local regulations regarding the disposal of such product.
WARNING
· For disposal of parts and accessories, where not otherwise specified, follow
local regulations regarding disposal of hospital waste.
21 - 4
22 Accessories
The accessory material that contacts the patients or other staff has undertaken the biocompatibility test and is verified to be in compliance with ISO 10993-1.
For details about the accessories, refer to the instructions for use provided with the accessory.
WARNING
· Use accessories specified in this chapter. Using other accessories may cause
damage to the equipment or not meet the claimed specifications.
· Single-use accessories are not designed to be reused. Reuse may cause a risk
of contamination and affect the measurement accuracy.
CAUTION
· The accessories may not meet the performance specifications if stored or
used outside the specified temperature and humidity ranges. If accessory
performance is degraded due to aging or environmental conditions, contact
your service personnel.
· Check the accessories and their packages for any sign of damage. Do not use
them if any damage is detected.
· Use the accessories before the expiry date if their expiry date is indicated. · The disposable accessories shall be disposed of according to hospital's
regulations.
22.1
SpO2 Accessories
Wavelength emited by the sensors is between 600 nm and 1000 nm.
The maximum photic output consumption of the sensor is less than 18 mW.
The information about the wavelength range and maximum photic output consumption can be especially useful to clinicians (for example, when photodynamic therapy is performed).
22 - 1
22.1.1 SpO2 Extension Cable
Module type
Remarks
Mindray SpO2 Module
7 pins, 2.5 m 7 pins, 1.2 m
Masimo SpO2 Module
8 pins, 2.1 m
8pin masimo Cable(RD SET)
Nellcor SpO2 Module 8 pins, 2.5 m
22.1.2 Mindray SpO2 Sensors
Model
520A 520P 520I 520N
Patient Category
Disposable SpO2 Sensor Disposable SpO2 Sensor Disposable SpO2 Sensor Disposable SpO2 Sensor
521A 521P 521I 521N /
518B 518BLH 518BLH 518C 513A
Disposable SpO2 Sensor Disposable SpO2 Sensor Disposable SpO2 Sensor Disposable SpO2 Sensor Disposable bandage, for 518C SpO2 Sensor Reusable SpO2 Sensor Reusable SpO2 Sensor Reusable SpO2 Sensor Disposable SpO2 Sensor Reusable SpO2 Sensor
512E
Reusable SpO2 Sensor
Part No.
Usage
0010-20-42710 Reusable 040-001443-00 Reusable 040-000332-00 Reusable 040-005973-00 Reusable
Applicable patient
/ / / /
0010-20-42712 Reusable /
Part No.
Applicable Application
patient
site
009-005087-00 Adult
Finger
009-005088-00 Pediatric Finger
009-005089-00 Infant
Toe
009-005090-00 009-005091-00
Neonate Adult Adult
Foot Finger Finger
009-005092-00 Pediatric Finger
009-005093-00 Infant
Toe
009-005094-00 Neonate
Foot
115-004895-00 Neonate
/
518B-30-72107 Neonate
115-020887-00 Neonate
115-050154-00 Neonate
040-000330-00 Neonate
115-033848-00 512E-30-90390
Adult, pediatric
Adult
Foot Foot Foot Foot Ear
Finger
22 - 2
Model
Patient Category
512F 512FLH 512G 512H
Reusable SpO2 Sensor Reusable SpO2 Sensor Reusable SpO2 Sensor Reusable SpO2 Sensor
Part No.
Applicable Application
patient
site
512F-30-28263 Adult
Finger
115-012807-00 Adult
Finger
512G-30-90607 Pediatric Finger
512H-30-79061 Pediatric Finger
22.1.3 Masimo SpO2 Sensors
Model
LNCS DCI 4050
Patient Category
Masimo P/N:1863 Adult, RD SET DCI
Part No.
Applicable Application
patient
site
0010-10-42600 040-003376-00
Adult (>30kg)
Finger Finger
*If you need to purchase Masimo sensors, please contact Masimo.
22.1.4 Nellcor SpO2 Sensors
Model Patient Category
MAXAI MAXPI
Disposable SpO2 Sensor Disposable SpO2 Sensor
MAXII Disposable SpO2 Sensor
MAXNI Disposable SpO2 Sensor
DS100A D-YS
Reusable SpO2 Sensor Reusable SpO2 Sensor
OXI-P/I Reusable SpO2 Sensor OXI-A/N Reusable SpO2 Sensor
Part No. 0010-10-12202 0010-10-12203 0010-10-12204 0010-10-12205
9000-10-05161 0010-10-12476
9000-10-07308 9000-10-07336
Applicable patient
Application site
Adult (>30 kg) Finger
Pediatric (10 to Finger 50 kg)
Infant (3 to 20 Toe kg)
Neonate (<3 kg), Adult (>40 kg)
Foot Finger
Adult
Finger
Adult, Pediatric, Infant, Neonate (>1 kg)
foot (1-3 kg), toe (3-15 kg), or finger (>15 kg)
Pediatric, infant
Finger
Adult, neonate Finger, foot
22 - 3
22.2 NIBP Accessories
22.2.1 NIBP Hoses
Model CM1903
Usage Reusable
Patient Category Adult, pediatric, neonate
CM1908
Part No.
6200-30-09688/115012522-00 040-002712-00
22.2.2 Reusable NIBP Cuffs
Model
Patient Category
CM1200 CM1201 CM1202 CM1203 CM1204 CM1205 CM1300 CM1301 CM1302 CM1303 CM1304 CM1305 CM1306 CM1307
Small Infant Infant Pediatric Adult Large adult Adult Small infant Infant Pediatric Adult Large adult Adult Adult Large adult
Measurement Limb Circumference Part No.
Site
(cm)
Arm
Thigh Arm
Thigh Arm
7 to 13 10 to 19 18 to 26 24 to 35 33 to 47 44 to 66 7 to 13 10 to 19 18 to 26 24 to 35 33 to 47 46 to 66 25 to 35 33 to 47
115-002480-00 0010-30-12157 0010-30-12158 0010-30-12159 0010-30-12160 0010-30-12161 040-000968-00 040-000973-00 040-000978-00 040-000983-00 040-000988-00 040-000993-00 115-015930-00 115-015931-00
22 - 4
22.2.3 Disposable NIBP Cuffs
Model
Patient Category
CM1500A CM1500B CM1500C CM1500D CM1500E CM1501 CM1502 CM1503 CM1504 CM1505 CM1506 CM1507 CM1500A CM1500B CM1500C CM1500D CM1500E CM1501 CM1502 CM1503 CM1504 CM1505 CM1506 CM1507
Neonate
Infant Pediatric Adult Large adult Adult Adult Large adult Neonate
Infant Pediatric Adult Large adult Adult Adult Large adult
Measurement Site
Limb Circumference (cm)
Part No.
Arm
Thigh Arm Arm
Thigh Arm
3.1 to 5.7 4.3 to 8.0 5.8 to 10.9 7.1 to 13.1 8 to 15 10 to 19 18 to 26 24 to 35 33 to 47 46 to 66 25 to 35 33 to 47 3.1 to 5.7 4.3 to 8.0 5.8 to 10.9 7.1 to 13.1 8 to 15 10 to 19 18 to 26 24 to 35 33 to 47 46 to 66 25 to 35 33 to 47
125-000046-00 125-000047-00 125-000048-00 125-000049-00 125-000050-00 001B-30-70697 001B-30-70698 001B-30-70699 001B-30-70700 001B-30-70701 115-016969-00 115-016970-00 125-000051-00 125-000052-00 125-000053-00 125-000054-00 125-000055-00 001B-30-70682 001B-30-70683 001B-30-70684 001B-30-70685 001B-30-70686 115-015940-00 115-015941-00
22.3 Temp Accessories
22.3.1 SmarTempTM Accessories
Probe Well
22 - 5
Model MR491 MR492
Usage Reusable
Description Blue, oral/axillary Red, Rectal
Part No. M09A-20-62062 M09A-20-62062-51
Temp Probes
Model Description Patient Category
Measurement Part No. Site
MR431 MR432
Reusable, box
MR431 MR432
Reusable, package
Probe Cover
Adult, Pediatric, Neonate Adult, Pediatric Adult, Pediatric, Neonate Adult, Pediatric
Oral/Axillary Rectal Oral/Axillary Rectal
6006-30-39598 6006-30-39599 6006-30-39600 6606-30-39601
Model
Usage
Patient Category Description
Part No.
ST-001
Disposable Adult, Pediatric, Neonate
Cover, 20 pcs/pack M09A-20-62124 Cover, 200 pcs/pack M09A-30-62126 Cover, 2000 pcs/pack M09A-30-62128
22.3.2 GeniusTM 3 Tympanic Thermometer Accessories
Tympanic Thermometer
Model 303075
Usage Reusable
Description Tethered tympanic thermometer
Part No. 115-038397-00
Probe Cover
Model Usage
Patient Category
Description
Part No.
303030 Disposable Adult, Pediatric, Neonate Cover, 96 pcs/case 100-000200-00
22.3.3 Exergen TemporalScannerTM Thermometer Accessories
Model Usage Description
124237- Reusable Exergen temporal scanner
AF-MR
thermometer
Model
TAT-5000SRS232
Part No. 040-003273-00
22 - 6
22.3.4 HeTaida Thermometer
Model HTD8808C
Usage Reusable
Description Non-contact Infrared Thermometer
Part No. 100-000446-00
22.4 CO2 Accessories
Model XS04620 XS04624 006324 007768 007737 007738 009818 007266 009822 007269 009826 007743 008177 008179 008180
Part No.
Description
0010-10-42560 0010-10-42561 0010-10-42562 0010-10-42563 0010-10-42564 0010-10-42565 0010-10-42566 0010-10-42567 0010-10-42568 0010-10-42569 0010-10-42570 0010-10-42571 0010-10-42572 0010-10-42574 0010-10-42575
Disposable airway sampling line
Disposable airway sampling line, humidified
Disposable airway sampling line, humidified
Disposable airway sampling line, long
Disposable airway sampling line, long, humidified
Disposable airway sampling line, long, humidified
Disposable nasal sampling line
Disposable nasal sampling line
Disposable nasal sampling line, plus O2
Disposable nasal sampling line, plus O2
Disposable nasal sampling line, long, plus O2
Disposable nasal sampling line, long, plus O2
Disposable nasal sampling line, humidified
Disposable nasal sampling line, humidified
Disposable nasal sampling line, humidified, plus O2
Applicable patient Adult/Pediatric Adult/Pediatric Neonatal Adult/Pediatric Adult/Pediatric Neonatal Adult Pediatric Adult
Pediatric
Adult
Pediatric
Adult Neonatal Adult
22 - 7
Model
Part No.
Description
008181
008174 008175 MVIIHL MVAIHL MVAIL MVIIH MVAIH MVAI MVPN MVAN MVANH MVA MVP MVPNOH MVAOL MVAO MVANOH MVINH MVPO MVPOL /
0010-10-42576
0010-10-42577 0010-10-42578 040-006160-00 040-006161-00 040-006162-00 040-006163-00 040-006164-00 040-006165-00 040-006166-00 040-006167-00 040-006168-00 040-006169-00 040-006170-00 040-006171-00 040-006172-00 040-006173-00 040-006174-00 040-006175-00 040-006176-00 040-006177-00 045-003134-00
Disposable nasal sampling line, humidified, plus O2 Disposable nasal sampling line Disposable nasal sampling line Intubated CO2 FilterLine Intubated CO2 FilterLine Intubated CO2 FilterLine Intubated CO2 FilterLine Intubated CO2 FilterLine Intubated CO2 FilterLine Nasal CO2 FilterLine Nasal CO2 FilterLine Nasal CO2 FilterLine Oral-Nasal CO2 FilterLine Oral-Nasal CO2 FilterLine Nasal CO2 FilterLine w/O2 H Oral-Nasal CO2 FilterLine w/O2 L Oral-Nasal CO2 FilterLine w/O2 Nasal CO2 FilterLine w/O2 H Nasal CO2 FilterLine H Oral-Nasal CO2 FilterLine w/O2 Oral-Nasal CO2 FilterLine w/O2 L CO2 adapter
Applicable patient Pediatric
Adult Pediatric Neonatal/Infant Adult/Pediatric Adult/Pediatric Neonatal/Infant Adult/Pediatric Adult/Pediatric Pediatric Adult Adult Adult Pediatric Pediatric Adult Adult Adult Neonatal/Infant Pediatric Pediatric /
22 - 8
22.5 Others
PN DA8K-10-14454 DA8K-10-14453 DA8K-10-14452 509B-10-05996 009-001075-00 009-001791-00 009-007190-00 009-007191-00 009-003116-00 009-003436-00 022-000248-00 022-000273-00 022-000122-00 045-004267-00 045-004268-00 045-004269-00 045-003054-00 045-003424-00 045-003427-00 115-020575-00 115-008393-00 115-039575-00 115-039635-00
Description Power cord, Europe Power cord, UK Power cord, USA Power cord, 10 A, 250 V, 1.6 m, China Power cord, 10 A, 250 V, 3 m, Brazil Power cord, 250 V, 16 A, 3 m, South Africa Power cord, 3 m, India Power cord, 1.8 m, Switzerland Nurse Call Cable Serial Port Cable Li-ion Battery (10.8V, 5600mA, LI23I003A, VS9) Li-ion Battery (10.95V, 5000mAh, LI23S005A, VS 8) Li-ion Battery (10.95V, 2500mAh, LI13S001A, VS8) Rolling stand (Standard) Rolling stand (with workbench) Rolling stand (with workbench & battery) Wall mount, standard Quick Release Tray GCXM Series 12" Bracket (with quick release kit A) Bedrail Clamp Barcode scanner kit Barcode reader, HS-1M, JADAK, 2D Barcode reader, HS-1R, JADAK, 2D
22 - 9
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22 - 10
A Product Specifications
A.1
Classifications
The equipment is classified, according to IEC60601-1:
A.2
Type of protection against electrical shock Degree of protection against electrical shock
Mode of operation Degree of protection against harmful ingress of water Degree of safety of application in the presence of a FLAMMABLE ANAESTHETIC MIXTURE WITH AIR or WITH OXYGEN OR NITROUS OXIDE Degree of mobility
CLASS I EQUIPMENT, equipment energized from an external and internal electrical power source.
DEFIBRILLATION-PROOF TYPE CF AAPPLIED PART for SpO2, NIBP, and SmarTempTM Temp TYPE BF APPLIED PART for GeniusTM 3 Temp Type B APPLIED PART for HeTaida Thermometer DEFIBRILLATION-PROOF TYPE BF APPLIED PART for CO2 and Exergen TemporalScanner TM Temp.
Continuous
IPX2 (Protection against vertically falling water drops when ENCLOSURE tilted up to 15°)
EQUIPMENT not suitable for use in the presence of a FLAMMABLE ANAESTHETIC MIXTUREWITH AIR or WITH OXYGEN OR NITROUS OXIDE
Portable
Environmental Specifications
A.2.1 Main Unit
Item Temperature
Relative humidity (noncondensing) Barometric
Operating conditions
0 to 40 ºC (without CO2) 5 to 40 ºC (with CO2) 15% to 95%
Storage conditions 20 to 60 ºC
10% to 95%
57.0 to 107.4 kPa (without CO2) 57.3 to 105.3 kPa (with CO2)
16.0 to 107.4 kPa (without CO2) 57.3 to 105.3 kPa (with CO2)
A - 1
A.2.2 SmarTempTM Temperature Module
Item
Temperature Relative humidity (noncondensing) Barometric
Operating conditions 5 ºC to 40 ºC Same as the main unit
Same as the main unit
Storage conditions Same as the main unit Same as the main unit
Same as the main unit
A.2.3 GeniusTM 3 Temperature Module
Item
Temperature Relative humidity (noncondensing)
Operating conditions 16ºC to 33 ºC 10% to 95%
Storage conditions 25 to 55 ºC 10%~95%
A.2.4 Exergen TemporalScanner Thermometer
Item
Temperature Relative humidity (noncondensing) Barometric
Operating conditions 16 to 40 ºC 15% to 95%
57.0 to 107.4 kPa
Storage conditions 20 to 50 ºC 10% to 95%
16.0 to 107.4 kPa
A.2.5 HeTaiDa Infrared Thermometer
Item
Temperature Relative humidity (noncondensing) Barometric
Operating conditions 16 to 35 ºC 15% to 85%
70.0 to 106.0 kPa
Storage conditions 20 to 45 ºC 10% to 93%
70.0 to 106.0 kPa
WARNING
· The equipment may not meet the performance specifications if stored or
used outside the specified temperature and humidity ranges.
A - 2
NOTE
· The environmental specifications of unspecified parameters are the same as
those of the main unit.
A.3 Power Supply Specifications
A.3.1 A.3.2
AC Power Supply Specifications
Line voltage Current Frequency Fuse
100 to 240 VAC (±10%) 0.9 to 0.5 A 50/60 Hz (±3 Hz) T2AL-250V
Battery Specifications of VS 9 Series
Battery Type Voltage Capacity Run time
Charge time Shutdown delay
Rechargeable lithium-Ion battery
10.8 VDC
5600 mAh
At least 8 hours when powered by a new, fully-charged battery at 25 °C ±5 °C on standard configuration (SpO2 and NIBP), with SpO2 sensor connected, auto NIBP measurement at an interval of 15 minutes, and screen brightness set to factory default. At least 5.3 hours when powered by a new, fully-charged battery at 25 °C ±5 °C on a configuration of SpO2, NIBP, SmarTemp and Wi-Fi, with SpO2 sensor and barcode scanner connected, auto NIBP measurement at an interval of 15 minutes, and screen brightness set to factory default. At least 4 hours when powered by a new, fully-charged battery at 25 °C ±5 °C on a configuration of SpO2, NIBP, CO2, Wi-Fi and recorder, with SpO2 sensor connected, auto NIBP measurement and auto recording at an interval of 10 minutes, and screen brightness set to factory default.
Monitor power off or standby: no more than 4 hours to 100% (at 25 °C ±5 °C). Monitor power on: no more than12.5 hours to 100%.
At least 20 minutes (after a low battery alarm first occurs) at 25 °C ±5 °C with SpO2 sensor connected, auto NIBP measurement at an interval of 15 minutes, and brightness set to factory default.
A - 3
A.3.3
Battery Supply Specifications of VS 8 Series
Battery Type Voltage Capacity Run time
Charge time
Shutdown delay
Rechargeable lithium-Ion battery
10.95 VDC
2500 mAh or 5000 mAh
At least 4 hours for the 2500mAh battery and at least 8 hours for the 5000mAh battery when powered by a new fully-charged battery at 25 °C ±5 °C on standard configuration (SpO2 and NIBP), with SpO2 sensor connected, auto NIBP measurement at an interval of 15 minutes and screen brightness set to factory default.
Monitor power off or standby: no more than 3 hours to 100% for the 2500mAh battery and no more than 4 hours to 100% for the 5000mAh battery (at 25 °C ±5 °C). Monitor power on: no more than 7.5 hours to 100% for the 2500mAh battery and no more than 11.5 hours to 100% for the 5000mAh battery.
At least 20 minutes (after a low battery alarm first occurs) at 25 °C ±5 °C with SpO2 sensor connected, auto NIBP measurement at an interval of 15 minutes, and brightness set to factory default.
A.4 Physical Specifications
A.5
A.5.1
A.5.2
Item VS 8 series (H*W*D)
VS 9 series (H*W*D)
Size
252mm x 170mm x150mm
Weight
2.5 kg (with Mindray SpO2 module, NIBP module, recorder module and a 5000 mAh battery; without capacitive screen; without accessory)
275mmx 185mm x 135mm
3.4 kg (with Mindray SpO2 module, NIBP module, recorder module and a battery; without accessory)
Hardware Specifications
Display Specifications of VS 9 Series
Screen type Screen Size (diagonal) Resolution
Color TFT LCD 10.1" 1280×800 pixels
Display Specifications of VS 8 Series
Screen type Screen Size (diagonal)
Color TFT LCD 8"
A - 4
Resolution
1024×768 pixels
A.5.3
Recorder Specifications
Method Paper speed
Thermal dot array 25 mm/s
A.5.4
LEDs
Alarm lamp Power on LED AC power LED Battery LED
1 (three color coded: cyan, yellow and red) 1 (green) 1 (green) 1 (two color coded: yellow and green)
A.5.5
Audio Indicator
Speaker
Give alarm tones (45 to 85 dB), key tones, pulse tone; power-on self-check tone, support PITCH TONE and multi-level tone modulation; alarm tones comply with IEC60601-1-8.
A.5.6
Monitor Interface Specifications
Power Wired network USB Equipotential Grounding Terminal Multi-Functions Connector External battery connector
1 AC power input connector 1 RJ45 connector 2 standard connectors, USB 2.0, type A 1 1 1
A.5.7 Outputs Specifications
Nurse Call Signal
Amplitude Rising and falling time
High level: 3.5 to 5 V, ±5%, providing a minimum of 10 mA output current Low level: <0.5 V, receiving a minimum of 5 mA input current
1 ms
Alarm output (Network connector)
A - 5
Alarm delay time from monitor to remote equipment
The alarm delay time form the monitor to remote equipment is 2 seconds, measured at the monitor's signal output connector.
A.5.8 Wi-Fi Technical Specifications
Standards
IEEE 802.11a/b/g/n/ac
Modulation mode BPSK, QPSK, 16QAM, 64QAM, 256QAM
Operating frequency
2412MHz~2472MHz, 5180MHz~5320Mz, 5500MHz~5700MHz, 5745MHz~5825MHz
Wireless data rate
IEEE 802.11a: 6-54 Mbps IEEE 802.11b: 1-11 Mbps IEEE 802.11g: 6-54 Mbps IEEE 802.11n: MCS0-MCS7 IEEE 802.11ac: MCS0-MCS8
Output power
<20 dBm (CE requirements, detection mode: RMS) <30 dBm (FCC requirements, detection mode: peak power)
Working mode
Infrastructure
Data security
Standard: WPA/WPA2-PSK, WPA/WPA2-Enterprise, WPA/WPA2 CCKM EAP method: LEAP, EAP-TTLS, EAP-TLS,EAP-FAST, PEAP-MsChapV2, PEAP-GTC,PEAP-TLS Encryption: TKIP and AES
A.5.9 Wi-Fi Performance Specifications
WARNING
· All network functions of data communication are designed to operate on a
private network.
A.5.9.1
System Capacity
Number of the monitors supported by a single AP: 16
Testing conditions are as follows:
Each monitor can communicate with the CMS. Only one monitor can transmit history data. The weakest strength of the AP signal where the monitor is located cannot be less
than -65 dBm.
A - 6
A.5.9.2
Resistance to Wireless Interference
The distance between the interfering devices and the monitor is greater than 20 cm. A Wi-Fi interference (no greater than -85 dBm) in the same channel and a Wi-Fi interference (no greater than -50 dBm) in an adjacent channel are presented synchronously. The interfering devices include 2.4 GHz wireless devices, cellular mobile networks, microwave ovens, intercoms, cordless phones, and ESU equipment. The interfering devices do not include Wi-Fi devices.
The monitoring network must support the following requirements:
The total delay of data transmission from the monitor to the CMS: 2 seconds.
The delay for monitor-related settings configured at the CMS to be effective: 2 seconds.
A.5.9.3
Wi-Fi Network Stability
There is no communication data loss when the monitor moves at a speed not higher than 3.75 m/s in a 15 meter obstacle-free linear range.
16 monitors are connected to the same AP and each roams for 30 times, of which at least 3 monitors roam simultaneously. The ratio of the communication data loss on the CMS from any monitor does not exceed 0.1% over a 24-hour period.
A.5.9.4 Line of Sight Distance
The line of sight distance between the monitor and the AP is no less than 50 meters.
A.5.10 Blue Tooth Specification
Protocol Modulation mode Operating frequency Wireless data rate Output power Data security
Bluetooth 5 GFSK 2402 ~ 2480MHz 2Mbps, 1Mbps, 125kbps 8 dBm ± 4 dB AES128
A.5.11 Bluetooth Performance Specifications
WARNING
· Keep the monitor away from interference sources. · Do not use Bluetooth nodes to perform realtime vital signs monitoring.
A - 7
A.5.11.1 System Capacity
In a range of 10 m2, there should be no more than 3 groups of paired monitors and bluetooth nodes working simultaneously.
A.5.11.2
Resistance to Interference
The distance between the interfering devices and the monitor is greater than 20 cm. The interfering devices include 2.4 GHz Wi-Fi devices, bluetooth communication devices, remote controls, microwave ovens, intercoms, cellular mobile networks, and cordless phones.
The monitoring network must support the following requirements:
The total delay of data transmission from the monitor to the bluetooth node: 6 seconds.
The success rate for transmission of vital signs data from the monitor to the bluetooth node: > 99%.
A.5.11.3 Line of Sight Distance
The line of sight distance between the monitor and the bluetooth node is no less than 10 meters.
A.6 Measurement Specifications
A.6.1 SpO2 Specifications
Alarm limit Range (%)
Step (%)
SpO2 High SpO2 Low
Desat
(low limit + 2) to 100
1
Mindray, Masimo: (Desat +1) to (high limit 2) Nellcor: (Desat+1) or 20 (whichever is greater) to (high limit 2)
0 to (low limit 1)
A.6.1.1 Mindray SpO2 Module Specifications
Standards
Meet standards of ISO 80601-2-61
*Measurement accuracy verification: The SpO2 accuracy has been verified in human experiments by comparing with arterial blood sample reference measured with a COoximeter. Pulse oximeter measurements are statistically distributed and about two-thirds of the measurements are expected to come within the specified accuracy range compared to CO-oximeter measurements.
SpO2 Measurement range 0 to 100%
PI measurement range
0.05% to 20%
SpO2 Resolution
1%
A - 8
PI Resolution
PI < 10.0: 0.01 PI 10.0: 0.1
Accuracy
70 to 100%: ±2% ABS (adult/pediatric) 70 to 100%: ±3% ABS (neonate) 0% to 69%: Not specified.
*Studies were performed to validate the accuracy of Pulse Oximeter with neonatal SpO2 sensors by contrast with a CO-Oximeter. Some neonates aged from 1 day to 30 days with a gestation age of 22 weeks to full term were involved in this study. The statistical analysis of data of this study shows the accuracy (Arms) is within the stated accuracy specification. Please see the following table.
Sensor type
Totally neonates
Data
Arms
518B
97 (51 male & 46 female) 200 pairs
2.38%
520N
122 (65 male & 57 female) 200 pairs
2.88%
The Pulse Oximeter with neonatal SpO2 sensors was also validated on adult subjects.
Refreshing rate
1 s
Response time
< 30 s (normal perfusion, no disturbance, SpO2 value sudden change within 70% 100%)
A.6.1.2 Masimo SpO2 Module Specifications
Standards
meets the requirements of ISO 80601-2-61
SpO2 Measurement range
1 to 100%
PI Measurement range
0.02 to 20%
SpO2 Resolution PI Resolution
1%
PI < 10.0: 0.01 PI 10.0: 0.1
Accuracy1
70% to 100%: ±2% ABS (without motion, adult/pediatric) 70% to 100%: ±3% ABS (without motion, neonate) 70% to 100%: ±3% ABS (with motion) 1% to 69%: Not specified.
Refreshing rate
1 s
Response time
20 s (normal perfusion, no disturbance, SpO2 value sudden change within 70% 100%)
SpO2 averaging time
2-4 s, 4-6 s, 8 s, 10 s, 12 s, 14 s, 16 s
A - 9
Low perfusion conditions
Pulse amplitude: >0.02% Light penetration: >5%
Low perfusion SpO2
±2%
accuracy2
1 The Masimo pulse oximeter with sensors have been validated for no motion accuracy in human blood studies on healthy adult volunteers in induced hypoxia studies in the range of 70% to 100% SpO2 against a laboratory co-oximeter and ECG monitor. This variation equals plus or minus one standard deviation. Plus or minus one standard deviation encompasses 68% of the population. One percent was added to the accuracies for neonatal sensors to account for accuracy variation due to properties of fetal hemoglobin. The Masimo pulse oximeter with sensors has been validated for motion accuracy in human blood studies on healthy adult volunteers in induced hypoxia studies while performing rubbing and tapping motions at 2 to 4 Hz. At an amplitude of 1 to 2 cm and non-repetitive motion between 1 to 5 Hz. At an amplitude of 2 to 3 cm in induced hypoxia studies in the range of 70% to 100% SpO2 against a laboratory co-oximeter and ECG monitor. This variation equals plus or minus one standard deviation. Plus or minus one standard deviation encompasses 68% of the population. 2 The Masimo pulse oximeter has been validated for low perfusion accuracy in bench top testing against a Biotek Index 2 simulator and Masimo's simulator with signal strengths of greater than 0.02% and a % transmission of greater than 5% for saturations ranging from 70 to 100%. This variation equals plus or minus one standard deviation. Plus or minus one standard deviation encompasses 68% of the population.
A.6.1.3 Nellcor SpO2 Module Specifications
Standards
Meet standards of ISO 80601-2-61
Measurement range
0 to 100%
Resolution
1%
Accuracy
70 to 100%: ±2% ABS (adult/pediatric) 70 to 100%: ±3% ABS (neonate) 0% to 69%: Not specified.
Refreshing rate
1 s
Response time
30 s (normal perfusion, no disturbance, SpO2 value sudden change within 70% 100%)
* When the SpO2 sensor is applied for neonatal patients as indicated, the specified accuracy range is increased by ±1%, to compensate for the theoretical effect on oximeter
measurements of fetal hemoglobin in neonatal blood.
Information of the Test Subjects of the Clinical Study Report
Skin color Gender
Number
Age (years)
Health
A - 10
Black
Male
1
Female
1
Yellow
Male
3
Female
9
A.6.2 PR
28.2±9.19
Healthy
Alarm limit PR High PR Low
Range (bpm)
PR 40: (low limit +2) to 40 PR > 40: (low limit +5) to 300
PR 40: 15 to (high limit - 2) PR > 40: 40 to (high limit - 5)
Step (bpm)
PR 40: 1 PR > 40: 5
A.6.2.1 PR from Mindray SpO2 Module
Measurement range Resolution Response time
Accuracy Refreshing rate
20 to 300 bpm 1 bpm < 30 s (normal perfusion, no disturbance, PR value sudden change within 25 220 bpm) ±3 bpm 1 s
A.6.2.2 PR from Masimo SpO2 Module
Measurement range Resolution Response time
Accuracy
Low perfusion conditions
Low perfusion PR accuracy1 Refreshing rate
25 to 240 bpm 1 bpm 20 s (normal perfusion, no disturbance, PR value sudden change within 25 220 bpm) ±3 bpm (without motion) ±5 bpm (with motion) Pulse amplitude: >0.02% Light penetration: >5% ±3 bpm 1 s
A - 11
1 The Masimo pulse oximeter has been validated for low perfusion accuracy in bench top testing against a Biotek Index 2 simulator and Masimo's simulator with signal strengths of greater than 0.02% and a % transmission of greater than 5% for saturations ranging from 70 to 100%. This variation equals plus or minus one standard deviation. Plus or minus one standard deviation encompasses 68% of the population.
A.6.2.3 PR from Nellcor SpO2 Module
Measurement range Resolution Response time
Accuracy
Refreshing rate
20 to 300 bpm 1 bpm 30 s (normal perfusion, no disturbance, PR value sudden change within 25 250 bpm) 20 to 250 bpm: ±3 bpm 251 to 300 bpm: not specified 1 s
A.6.2.4 PR from NIBP Module
Measurement range Resolution Accuracy
30 to 300 bpm 1 bpm ±3 bpm or ±3%, whichever is greater
A.6.3
NIBP
Standards
Meet standards of IEC 80601-2-30, ISO 81060-2
Technique
Oscillometry
Mode of operation
Manual, Auto, STAT, Sequence, and BP averaging
Auto mode repetition intervals
1 min, 2 min, 2.5 min, 3 min, 5 min, 10 min, 15 min, 20 min, 30 min, 1 hour, 1.5 hours, 2 hours, 3 hours, 4 hours, 8 hours
STAT mode cycle time 5 min
Typical measurement time
Adult: 15 s (Inflation algorithm, measured with CM1203/ CM1303/CM1503 cuff, PR within 60 to 200 bpm and systolic pressure within 80 to 120 mmHg)
Pediatric: 15 s (Inflation algorithm, measured with CM1202/ CM1302/CM1502 cuff, PR within 60 to 200 bpm and systolic pressure within 80 to 120 mmHg)
Max measurement time Adult, pediatric:
180 s
Neonate:
90 s
Heart rate range
30 to 300bpm
A - 12
Measurement ranges (mmHg)
Systolic:
Adult 25 to 290
Pediatric 25 to 240
Diastolic:
10 to 250
10 to 200
Mean:
15 to 260
15 to 215
Accuracy
Max mean error: ±5 mmHg Max standard deviation: 8 mmHg
Static pressure measurement range
0 mmHg to 300 mmHg
Static pressure
±3 mmHg
measurement accuracy
Resolution
1 mmHg
Initial cuff inflation pressure range (mmHg) (Deflation algorithm)
Adult: Pediatric: Neonate:
80 to 280 80 to 210 60 to 140
Default initial cuff inflation pressure (mmHg) (Deflation algorithm)
Adult:
160
Pediatric:
140
Neonate:
90
Software overpressure protection
Adult: Pediatric: Neonate:
297±3 mmHg 297±3 mmHg 147±3 mmHg
Hardware overpressure protection
Adult: Pediatric: Neonate:
330 mmHg 330 mmHg 165 mmHg
Alarm limit
Range (mmHg)
Neonate 25 to 140 10 to 115 15 to 125
Step (mmHg)
A - 13
Sys High
Sys Low Mean High
Mean Low Dia High
Dia Low
Adult: (low limit+5) to 290 Pediatric: (low limit+5) to 240 Neonate: (low limit+5) to 140
25 to (high limit-5)
Adult: (low limit+5) to 260 Pediatric: (low limit+5) to 215 Neonate: (low limit+5) to 125
15 to (high limit-5)
Adult: (low limit+5) to 250 Pediatric: (low limit+5) to 200 Neonate: (low limit+5) to 115
10 to (high limit-5)
50: 1 > 50: 5
* Measurement accuracy verification: In adult and pediatric modes, the blood pressure measurements measured with this device are in compliance with the American National Standard for Electronic or Automated Sphymomanometers (ANSI/AAMI SP10) in terms of mean error and standard deviation by comparing with intra-arterial or auscultatory measurements (depending on the configuration) in a typical patient population. For auscultatory reference, the 5th Korotkoff sound was used to determine the diastolic pressure.
In neonatal mode, the blood pressure measurements measured with this device are in compliance with the American National Standard for Electronic or Automated Sphymomanometers (ANSI/AAMI SP10) in terms of mean error and standard deviation by comparing with intra-arterial measurements (depending on the configuration) in a typical patient population.
A.6.4 Temp Specifications
A.6.4.1 Specifications of the SmarTempTM Temperature Module
Standards Technique Operating mode Measurement range Accuracy (Monitor mode)
Meets standards of ISO 80601-2-56
Thermal resistance (use thermistor to measure temperature)
Adjusted mode (predictive mode) Direct mode (monitor mode)
Monitor mode: 25 °C to 44 °C (77 °F to 111.2 °F) Predictive mode: 34 °C to 43 °C (93.2 °F to 109.4 °F)
25 °C to 32 °C (not including 32 °C): ±0.2 °C 32 °C to 44 °C (including 32 °C): ±0.1 °C or 77 °F to 89.6 °F (not including 89.6 °F): ±0.4 °F 89.6 °F to 111.2 °F (including 89.6 °F): ±0.2 °F
A - 14
Resolution Minimum measurement time for accurate readings
Alarm limit Temp High Temp Low
0.1 °C
Monitor mode: <60 s Predictive mode: <20 s (typical test:< 12 s)
Range
Step
(low limit +1) °C to 44 °C 25 °C to (high limit -1) °C
0.1 °C
Statistical Results of Clinical Investigation Data
Oral Axilla Rectum
Clinical BIAS (cb)
0.02 0.06 -0.05
Limits of Agreement Clinical
(LA)
Repeatability (r)
0.33
0.1
0.38
0.13
0.48
0.14
A.6.4.2 Specifications of the GeniusTM 3 Tethered Tympanic Thermometer
Operating mode Measurement range Accuracy
Adjusted mode 33.0 °C to 42.0 °C (91.4 °F to 107.6 °F) ±0.3 °C
A.6.4.3 Specifications of the Exergen TemporalScannerTM Thermometer
Measurement range Measurement accuracy Resolution Battery Specifications Type Voltage Run time
16.0°C to 43.0 °C ± 0.2 °C 0.1 °C
Alkaline battery 9V Approximately one hour continuous use or 15000 readings
A.6.4.4 Specifications of the HeTaiDa Infrared Thermometer
Measurement range Measurement accuracy
34.0°C to 42.9 °C
34.0°C to 34.9°C: ±0.3°C 35.0°C to 42.0°C: ±0.2°C 42.1°C to 42.9°C: ±0.3°C
A - 15
A.6.5
CO2 Specifications
Standard Technique Apnea delay Measurement range Accuracy
Accuracy drift Resolution Sample flowrate Sample flowrate tolerance Start-up time Response time
Rise time
Meet standard of ISO 80601-2-55
Infrared absorption
10 s, 15 s, 20 s, 25 s, 30 s, 35 s, 40 s
0 to 150 mmHg
Full accuracy mode: 0 to 40 mmHg: ±2mmHg 41 to 76 mmHg: ±5% of reading 77 to 99 mmHg: ±10% of reading 100 to 150mmHg: ±(3mmHg + 8% of reading) >150mmHg CO2: unspecified ISO accuracy mode: Add ±2 mmHg to the full accuracy mode
Meet the requirement for measurement accuracy within 6 hours.
1 mmHg
Connecting the Oridion sampling line: 50 ml/min
±15% or ±15 ml/min, whichever is greater.
20 s (typical), 90 s (maximum)
Measured with an Oridion sampling line: 5 s @ 50 ml/min (standard sampling line) or 6.5 s @ 50 ml/min (extended sampling line) Measured with a DRYLINETM PRIME sampling line: 5 s @ 50 ml/min
Measured with an Oridion sampling line: 250 ms @ 50 ml/min (standard sampling line) or 280 ms @ 50 ml/min (extended sampling line) Measured with a DRYLINETM PRIME sampling line: 200 ms @ 50 ml/ min
Effect of interference gases on CO2 measurement
Gas
Concentration (%)
Quantitative effect*
N2O
60
Hal
4
Sev
5
Iso
5
Enf
5
±1 mmHg
A - 16
A.6.6
Des
15
±2 mmHg
*: means an extra error should be added in case of gas interference when CO2 measurements are performed between 0 to 40 mmHg. Inaccuracy specifications are affected by the breath rate and I:E change. The end-tidal gas reading is within specification for breath rate below 15 bpm and I:E ratio smaller than 1:1 relative to the gas readings without breath.
Alarm limit
Range
Step
EtCO2 High EtCO2 Low FiCO2 High
(low limit + 2) to 99 mmHg 1 to (high limit 2) mmHg 1 to 99 mmHg
1 mmHg
RR Specifications
Alarm limit RR High
RR Low
Range
RR 20 rpm: (low limit + 2) to 20 rpm RR >20 rpm: Adult, pediatric: (low limit + 5) to 100 rpm Neonate: (low limit + 5) to 150 rpm
RR 20 rpm: 0 to (high limit 2) rpm RR >20 rpm: 20 to (high limit 5) rpm
Step (rpm)
20: 1 > 20: 5
A.6.6.1 RR from Mindray CO2 Module
Measurement range Measurement precision
Resolution
0 to 150 rpm <60 rpm: ±1 rpm 60 to 150 rpm: ±2 rpm 1 rpm
A.6.6.2 RR from Mindray SpO2 Module
Measurement range Measurement precision Resolution Time for first measurement Refreshing rate
4 to 70 rpm Arms: 3rpm, mean difference [-1,1] rpm 1 rpm 30 s 1 s
A - 17
A.7
Operating Environment
Host CPU Primary programming language Operating system
AM3358 C++ Linux 3.2.0
A - 18
B EMC and Radio Regulatory Compliance
B.1
EMC
The device meets the requirements of IEC 60601-1-2: 2014.
NOTE
· Use of accessories, transducers and cables other than those specified or
provided by the manufacturer of this device could result in increased electromagnetic emissions or decreased electromagnetic immunity of this device and result in improper operation.
· The non-ME EQUIPMENT (e.g. ITE) that is a part of an ME SYSTEM may be
disrupted by the electromagnetic interference of nearby equipment. It may be necessary to take mitigation measures, such as re-orienting or relocating the non-ME EQUIPMENT or shielding the location.
· Use of this device adjacent to or stacked with other device should be avoided
because it could result in improper operation. If such use is necessary, this device and the other device should be observed to verify that they are operating normally.
· This device is intended for use in professional healthcare facility EMC
environment. If it is used in special environment, such as magnetic resonance imaging environment, the equipment/system may be disrupted by the operation of nearby equipment.
· Portable RF communications equipment (including peripherals such as
antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of the this device, including cables specified by the manufacturer. Otherwise, degradation of the performance of this device could result.
B - 1
Guidance and Declaration Electromagnetic Emissions
The device is intended for use in the electromagnetic environment specified below. The customer or the user of the device should assure that it is used in such an environment.
Emission tests
Compliance
Electromagnetic environment guidance
Conducted and radiated RF EMISSIONS
CISPR 11
Group 1
Conducted and radiated RF EMISSIONS
CISPR 11
Class A
Harmonic distortion IEC 61000-3-2
Voltage fluctuations and flicker IEC 61000-3-3
Class A Complies
The device uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic device.
The device is suitable for use in all establishments other than domestic and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.
The device is suitable for use in all establishments, including domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.
If the device is operated within the electromagnetic environment listed in Table Guidance and Declaration -- Electromagnetic Immunity, the system will remain safe and provide the following essential performance,
Operating mode Accuracy Function Accessories identification Data stored Alarm Detect for connection
B - 2
NOTE
· If the essential performance is lost or degraded, it may be necessary to take
mitigation measures, such as re-orienting or relocating the ME EQUIPMENT
or ME SYSTEM or shielding the location or stopping using the monitor and
contact the service personnel.
· The device needs special precautions regarding EMC and needs to be
installed and put into service according to the EMC information provided in
appendix B.
· Other devices may affect this device even though they meet the
requirements of CISPR.
· When the inputted signal is below the minimum amplitude provided in
technical specifications, erroneous measurements could result.
· The EMISSIONS characteristics of this device make it suitable for use in
industrial areas and hospitals (CISPR 11 class A). If it is used in a residential
environment (for which CISPR 11 class B is normally required) this device
might not offer adequate protection to radio-frequency communication
services. The user might need to take mitigation measures, such as relocating
or re-orienting the device.
Guidance and Declaration Electromagnetic Immunity
The device is intended for use in the electromagnetic environment specified below. The customer or the user of the device should assure that it is used in such an environment.
Immunity test
IEC60601 test level
Compliance level
Electromagnetic environment guidance
Electrostatic discharge (ESD) IEC 61000-4-2
±8 kV contact ±15 kV air
Electrical fast transient/burst IEC 61000-4-4
±2 kV for power supply lines
±1 kV for input/ output lines
(length greater than 3 m)
Surge IEC 61000-4-5
±1 kV line(s) to line(s)
±2 kV line(s) to earth
±8 kV contact ±15 kV air
±2 kV for power supply lines ±1 kV for input/ output lines (length greater than 3 m) ±1 kV line(s) to line(s) ±2 kV line(s) to earth
Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%.
Mains power quality should be that of a typical commercial or hospital environment.
B - 3
Voltage dips and Voltage interruptions IEC 61000-4-11
0% UT for 0.5 cycle
0% UT for 1 cycle and 70% UT for 25/ 30 cycles
0% UT for 250/300 cycles
0% UT for 0.5 cycle
0% UT for 1 cycle and 70% UT for 25/ 30 cycles
0% UT for 250/300 cycles
Mains power quality should be that of a typical commercial or hospital environment. If the user of our product requires continued operation during power mains interruptions, it is recommended that our product be powered from an uninterruptible power supply or a battery.
RATED power frequency magnetic fields
IEC 61000-4-8
30 A/m 50 Hz/60 Hz
30 A/m 50 Hz/60 Hz
Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment.
Note: UT is the AC mains voltage prior to application of the test level.
B - 4
Guidance and Declaration Electromagnetic Immunity
The device is intended for use in the specified electromagnetic environment. The customer or the user of the device should assure that it is used in such an environment as described below.
Immunity IEC60601
test
test level
Complia nce level
Electromagnetic environment guidance
Conducted disturbanc es induced by RF fields
IEC610004-6
3 Vrms 150 kHz to 80 MHz
6 Vrms in ISM bands and amateur radio bandsa between 0,15 MHz and 80 MHz
3 Vrms 6 Vrms
Radiated RF EM fields
IEC610004-3
3 V/m
80 MHz to 2.7 GHz
3 V/m
Proximity fields from RF wireless communic ations equipment
IEC610004-3
27 V/m 380390 MHz
28 V/m 430470 MHz, 800 960 MHz, 17001990 MHz, 2400 2570 MHz
27 V/m 28 V/m
9 V/m
704787 MHz, 5100 5800 MHz
9 V/m
Portable and mobile RF communications equipment should be used no closer to any part of the device, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Recommended separation distance:
150k to 80 MHz d = 3---V-.-5-- P
80 MHz to 80 0MHz d = 3----.-5-- P
E
800 MHz to 2.7GHz d = 7-E- P
where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in meters (m).
Field strengths from fixed RF transmitters, as determined by an electromagnetic site surveyb, should be less than the compliance level in each frequency rangec.
Interference may occur in the vicinity of equipment marked with the following symbol:
Note 1: At 80 MHz and 800 MHz, the higher frequency range applies. Note 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.
B - 5
a The ISM (industrial, scientific, and medical) bands between 150 kHz and 80 MHz are 6.765 MHz to 6.795 MHz; 13.553 MHz to 13.567 MHz; 26.957 MHz to 27.283 MHz; and 40.66 MHz to 40.70 MHz. The
amateur radio bands between 0,15 MHz and 80 MHz are 1,8 MHz to 2,0 MHz, 3,5 MHz to 4,0 MHz, 5,3 MHz to 5,4 MHz, 7 MHz to 7,3 MHz, 10,1 MHz to 10,15 MHz, 14 MHz to 14,2 MHz, 18,07 MHz to 18,17 MHz, 21,0 MHz to 21,4 MHz, 24,89 MHz to 24,99 MHz, 28,0 MHz to 29,7 MHz and 50,0 MHz to 54,0 MHz. b Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the device is used exceeds the applicable RF compliance level above, the device should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the device. c Over the frequency ranges 150 kHz to 80 MHz, field strengths should be less than 3V/m.
WARNING
· The device is configured with a wireless network connector to receive
wireless signal. Other devices may interfere with this device even though they meet the requirements of CISPR.
Recommended Separation Distances between Portable and Mobile RF, Communications Equipment and This Equipment
The equipment is intended for use in an electromagnetic environment in which radiated RF disturbance are controlled. The customer or the user of the device can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the device as recommended below, according to the maximum output power of the communication equipment.
Rated Maximum Output power of Transmitter Watts
(W)
Separation Distance According to Frequency of Transmitter (m)
150 kHz to 80 MHz d = 3---V-.-5-- P
80 MHz to 800 MHz 800 MHz to 2.7 GHz
d = 3---E-.-5-- P
d = 7-E- P
0.01
0.12
0.12
0.23
0.1
0.38
0.38
0.73
1
1.2
1.2
2.3
10
3.8
3.8
7.3
B - 6
100
12
12
23
For transmitters at a maximum output power not listed above, the recommended separation distanced in meters (m) can be determined using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer.
Note 1: At 80 MHz and 800 MHz, the higher frequency range applies.
Note 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.
B.2 Radio Regulatory Compliance
The radio device used in this product is in compliance with the essential requirements and other relevant provisions of Directive 2014/53/EU.
This device complies with Part 15 of the FCC Rules and RSS-210 of Industry Canada. Operation is subject to the following two conditions: (1) this device may not cause harmful interference, and (2) this device must accept any
interference received, including interference that may cause undesired operation.
Any changes or modifications to this equipment not expressly approved by Mindray may cause harmful radio frequency interference and void your authority to operate this equipment.
The maximum antenna gain permitted complies with the e.i.r.p. limits as stated in RSS210.
The maximum antenna gain permitted complies with the e.i.r.p. limits specified for point-to-point operation, as stated in RSS-210.
WARNING
· Changes or modifications not expressly approved by the party responsible
compliance could void the user's authority to operate the equipment.
B - 7
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B - 8
C Default Settings
C.1 Parameters Default Settings
C.1.1 SpO2 Default Settings
Item Alarm
SpO2
On/Off High
Setup
Low
Priority
SpO2 Desat
On/Off
Low
Priority
NIBP Simul
Sat-Seconds (for Nellcor SpO2)
Sensitivity (for Mindray SpO2)
Sensitivity (for Masimo SpO2)
Averaging (for Masimo SpO2)
Display PI (for Mindray SpO2, Masimo SpO2)
Speed
Default Setting On Adult and pediatric: 100% Neonate: 95% 90% Med On 80% High Off Off Med APOD 8 s On 25 mm/sec
C - 1
C.1.2 PR
Item
PR Alarm
PR
On/Off High
Low
PR Setup
Pulse Volume
Priority
C.1.3 Temp Default Settings (SmarTemp)
Default Setting
On
Adult: 120 Pediatric: 160 Neonate: 200
Adult: 50 Pediatric: 75 Neonate: 100
Med
2
Item Alarm
Temp
C.1.4 NIBP Default Settings
On/Off High Low Priority
Default Setting Off 38.0 °C 35.0 °C Med
Item Alarm
NIBP-S
On/Off High
Low
Priority
Default Setting
On
Adult: 160 mmHg Pediatric: 120 mmHg Neonate: 90 mmHg
Adult: 90 mmHg Pediatric: 70 mmHg Neonate: 40 mmHg
Med
C - 2
Item Alarm
NIBP-D
On/Off High
Low
NIBP-M
Priority On/Off High
Low
NIBP-S Extreme
Priority On/Off High
Low
Priority NIBP-D Extreme On/Off
High
Low
Priority
Default Setting
On
Adult: 90 mmHg Pediatric: 70 mmHg Neonate: 60 mmHg
Adult: 50 mmHg Pediatric: 40 mmHg Neonate: 20 mmHg
Med
On
Adult: 110 mmHg Pediatric: 90 mmHg Neonate: 70 mmHg
Adult: 60 mmHg Pediatric: 50 mmHg Neonate: 25 mmHg
Med
Off
Adult: 175 mmHg Pediatric: 130 mmHg Neonate: 95 mmHg
Adult: 75 mmHg Pediatric: 60 mmHg Neonate: 35 mmHg
High
Off
Adult: 105 mmHg Pediatric: 80 mmHg Neonate: 65 mmHg
Adult: 35 mmHg Pediatric: 30 mmHg Neonate: 15 mmHg
High
C - 3
Item Alarm
NIBP-M Extreme
On/Off High
Low
Setup
Initial Pressure
Priority
Sequence
Interval
Start Mode
NIBP End Tone
Venipuncture Pressure
Display Format
Display Alarm Limits
Patient Position
Measurement Site
Phase A
Duration
Interval
Phase B
Duration
Interval
Phase C
Duration
Interval
Phase D
Duration
Interval
Phase E
Duration
Interval
Default Setting
Off Adult: 125 mmHg Pediatric: 100 mmHg Neonate: 75 mmHg Adult: 45 mmHg Pediatric: 40 mmHg Neonate: 20 mmHg High Adult: 160 mmHg Pediatric: 140 mmHg Neonate: 90 mmHg Sequence Clock Off Auto Sys/Dia(Mean) Off Lying Unspecified 1 hr 5 min 4 hrs 15 min 4 hrs 30 min Continuous 1 hr Off 1 hr
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C.1.5 CO2 Default Settings
Item Alarm
Setup
RR
On/Off
High
Low
Apnea EtCO2
Priority On/Off Priority On/Off High
Low
FiCO2 Apnea Delay
Priority On/Off High Priority
Operating Mode Auto Standby BTPS Compensation O2 Compensation N2O Compensation
Default Setting
On Adult and pediatric: 30 rpm Neonate: 100 rpm Adult and pediatric: 8 rpm Neonate: 30 rpm Med On (Locked) High On Adult and pediatric: 50 mmHg Neonate: 45 mmHg Adult and pediatric: 25mmHg Neonate: 30 mmHg Med On 4 mmHg Med Adult and pediatric: 20 sec Neonate: 15 sec Measure 60 min Off 21% 0%
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Item Setup
AG Compensation Speed CO2 Scale Waveform Type
Default Setting 0% 6.25 mm/sec 50 mmHg Draw
C.1.6 EWS Default Settings
Item EWS
Score Score Confirmation Auto Scoring /
Interval
Manual Data Timeout
SpO2 Supp. O2 PR LOC
Default Setting NEWS2 On Off By Score 4 hrs (Score: 0) 2 hrs (Score: 1~4) 1 hr (Score: 5~6) 30 min (Score: 7~20) 4 hrs 24 hrs 1 hr 24 hrs
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Item Alarm
Alarm
Auto Refresh Scores
Alarm
EWS Score
Priority
On/Off
High
Priority
On/Off
High
3 in single parameter
RR SpO2
BP-S
PR
Temp
C.2 Routine Default Settings
C.2.1 Alarm Default Settings
Default Setting On Off Med On 5 High On 7 Off, Med Off, Med Off, Med Off, Med Off, Med
Item Alarm Volume High Alarm Volume Reminder Volume Apnea Delay
Default Setting
2 Alarm Volume+3 2 Adult and pediatric: 20 sec Neonate: 15 sec
C.2.2 Parameter Color Default Settings
Item SpO2
Default Setting Cyan
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Item NIBP Temp RR CO2
Default Setting White White Yellow Yellow
C.2.3 Display Default Settings
Item Screen Lock Duration Brightness Brightness On Battery
Default Setting 10 sec 5 5
C.2.4 Volume Default Settings
Item Alarm Volume High Alarm Volume Reminder Volume Key Volume
C.2.5 Record Setup
Item Waveform 1 Waveform 2 Recording Duration Recorder Paper Speed
Default Setting 2 Alarm Volume+3 2 2
Default Setting Off Off 8 sec 25 mm/sec
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C.2.6 System Time Default Settings
Item Date Format 24-Hour Time Daylight Savings Time
Default Setting yyyy-mm-dd On Off
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D Alarm Messages
This chapter lists only the physiological and technical alarm messages. Some messages appearing on your monitor may not be included. In the "Cause and solution" column, corresponding solutions are given instructing you to troubleshoot problems. If the problem persists, contact your service personnel.
D.1 Physiological Alarm Messages
D.1.1 General Physiological Alarm Messages
D.1.2
Alarm messages
Default priority
Cause and solution
XX High
Med
XX Low
Med
XX value has risen above the high alarm limit or fallen below the low alarm limit. Check the patient's condition and check if the patient category and alarm limit settings are correct.
Note:XX represents a measurement or parameter label, such as NIBP, RR, SpO2, CO2, PR, and so on.
SpO2 Physiological Alarm Messages
Alarm message
SpO2 Desat
Default priority
High
Cause and solution
The SpO2 value falls below the desaturation alarm limit. Check the patient's condition and check if the alarm limit settings are correct.
D.1.3 PR Physiological Alarm Messages
Alarm message
No Pulse
Default priority
High
Cause and solution
The pulse signal was so weak that the monitor cannot perform pulse analysis. Check the patient's condition, SpO2 sensor and measurement site.
D - 1
D.1.4 NIBP Physiological Alarm Messages
Alarm message
Default priority
Cause and solution
NIBP-S Extremely High/NIBP-D Extremely High/ NIBP-M Extremely High
High
NIBP-S Extremely Low/NIBP-D Extremely Low/ NIBP-M Extremely Low
High
The NIBP value is higher than the NIBP Extreme alarm high limit. Check the patient's condition and check if the alarm limit settings are correct.
The NIBP value is lower than the NIBP Extreme alarm low limit. Check the patient's condition and check if the alarm limit settings are correct.
D.1.5 EWS Physiological Alarm Messages
Alarm message EWS Score > N XX score = 3
Default priority
High/ Mediate
Mediate
Cause and solution
The total score exceeds the configured alarm limit. Check the patient condition.
The parameter score is 3. Check the patient condition.
D.2
Note:N represents a numeric. XX represents RR, SpO2, BP-S, BP-D, BP-M, PR, Temp, EtCO2.
Technical Alarm Messages
This section lists technical alarms, their default priority, indication on alarm reset, and the actions that can be taken when an alarm occurs.
Technical alarms give different alarm indicators when the alarm system is reset. In this section we classify the technical alarms into three categories for easy clarification:
A: technical alarms are cleared. The monitor gives no alarm indications. B: technical alarms are changed to the prompt messages. C: the alarm is silenced and a appears before the alarm message, indicating that
the alarm is acknowledged. In the following tables we will use A, B, and C to refer to the indications on alarm reset.
D - 2
D.2.1 General Technical Alarm Messages
D.2.2
Alarm message Default Indication on priority alarm reset
Cause and solution
XX Module Error High
C
XX module does not work properly. Contact your service personnel.
Note:XX represents a measurement or parameter label, such as SpO2, NIBP, CO2, and so on.
SpO2 Technical Alarm Messages
Alarm message SpO2 Sensor Off
SpO2 No Sensor
SpO2 Excess Light SpO2 No Pulse
SpO2 Sensor Incompatible
Default priority Low
Low
Low Low
Low
Indication on alarm reset B
A
C C
C
Cause and solution
The SpO2 sensor has become detached from the patient or the module. Check the sensor connection. If the alarm persists, replace the sensor.
The SpO2 extension cable is detached from the SpO2 module, or the SpO2 sensor is detached from the SpO2 extension cable. Check the SpO2 cable and the sensor connection. If the alarm persists, replace the sensor.
Ambient light is too strong. Move the sensor to a place with lower level of ambient light or cover the sensor to minimize the ambient light.
The SpO2 sensor failed to obtain pulse signal. Check the patient's condition and replace the sensor application site. If the alarm persists, replace the sensor.
Incompatible or an unspecified SpO2 sensor is used. Use specified sensors.
D - 3
Alarm message Default priority
SpO2 Low Signal Low Quality
SpO2
Low
Interference
SpO2 Sensor Error
SpO2 Searching Pulse
SpO2 Low Perfusion
Low Prompt Prompt
Replace SpO2
Low
Cable
Prompt
Incompatible
Low
SpO2 Cable
Replace SpO2 Sensor
Low Prompt
Check SpO2
Low
Sensor
Connection
Indication on alarm reset C
C C / /
C
C C
C
Cause and solution
1. Check the sensor and sensor position. 2. Make sure the patient is not shivering or moving. 3. The patient's pulse may be too low to be measured.
The SpO2 signal has been interfered. Check for any possible sources of signal noise and check the patient for excessive motion.
Replace the sensor and measure again.
SpO2 is searching for pulse.
The SpO2 sensor is not properly placed or the patient's perfusion index is too low. 1. Check the sensor and sensor position. 2. Reposition the sensor if necessary.
The SpO2 cable expired, cannot be recognized, or failed. Replace the SpO2 cable.
The SpO2 cable is about to expire. Replace the SpO2 cable.
The SpO2 cable connected is not compatible with the equipment. Replace the SpO2 cable.
The SpO2 sensor expired. Replace the SpO2 sensor.
The SpO2 sensor is about to expire. Replace the SpO2 sensor.
No SpO2 sensor is connected. Connect an SpO2 sensor.
D - 4
Alarm message
SpO2 No Cable Connected
Default priority
Low
Indication on alarm reset
C
Cause and solution
No SpO2 cable is connected. Connect an SpO2 cable.
D.2.3 Temp Technical Alarm Messages
Alarm message
Cannot Take Neonatal Rectal Temp (for SmarTemp)
Temp No Probe (for SmarTemp)
Default priority High
Med
Temp Probe
Med
Misplaced (for
SmarTempTM)
Temp Measuring Med Timeout (for SmarTempTM)
Ambient Temp
Low
Overrange (for
SmarTempTM)
Temp Overrange Low (for SmarTempTM)
Thermal Resistor Med Err (for SmarTempTM)
TempIF Thermometer Error (for GeniusTM 3)
High
Indication on alarm reset
Cause and solution
B
Rectal measurement is not
applicable for neonatal patient.
Select another site.
B
The Temp probe is disconnected or
damaged. Reconnect the probe. If
the problem persists, change for
another probe.
A
The measured value is invalid.
Replace the probe and check the
value.
B
The measurement has exceeded
regular measurement time. Try
another measurement.
A
The ambient temperature is too low.
Move the patient to a warmer place
and take temperature measurement
again if necessary.
C
The temperature measurement
exceeds the measurement range.
Check the patient's condition.
C
The Temp module may fail. Take
temperature measurement again. If
the alarm persists, contact your
service personnel.
C
The thermometer may fail. Take
temperature measurement again. If
the alarm persists, replace the
thermometer.
D - 5
Alarm message
TempIF Ambient Temp High (for GeniusTM 3)
Default priority
Low
TempIF Ambient Low Temp Low (for GeniusTM 3)
TempIF Overrange (for GeniusTM 3)
Ambient Temp Overrange (for HeTaiDa)
Low Prompt
Ambient Temp Unstable (for HeTaiDa)
Prompt
Measurement Mode Unsupported (for HeTaiDa)
Prompt
Indication on Cause and solution alarm reset
C
The ambient temperature is too
high. Move the patient to a cooler
place and take temperature
measurement again if necessary.
C
The ambient temperature is too low.
Move the patient to a warmer place
and take temperature measurement
again if necessary.
C
The temperature measurement
exceeds the measurement range.
Check the patient's condition.
/
The ambient temperature is out of
the specified range. Move the
patient to a place where the
temperature is within in the
specified range and take
temperature measurement again if
necessary.
/
The ambient temperature changes
greatly. Move the patient to a place
of stable temperature and take
temperature measurement again if
necessary.
/
Change the measurement mode of
the thermometer to forehead.
D.2.4 NIBP Technical Alarm Messages
Alarm message NIBP Cuff Loose
Default priority
Low
Indication on
alarm reset
Cause and solution
A
There is a leak in the cuff or air
tubing. Use a cuff of correct type
based on the patient size. Apply the
cuff and connect the air tubing as
instructed in the manual.
D - 6
Alarm message NIBP Timeout
Default priority
Low
NIBP Cuff or
Low
Airway Leak
NIBP Airway Leak Low
NIBP Airway Error Low
NIBP Weak Signal Low
NIBP Excessive
Low
Motion
NIBP Cuff and
Low
Patient Mismatch
NIBP Cuff
Low
Overpressure
NIBP Overrange Low
Indication on Cause and solution alarm reset
A
The measurement time exceeds 120
seconds in the adult or pediatric
mode, or exceeds 90 seconds in the
neonatal mode, and the BP value
cannot be obtained. Check the
patient's condition and NIBP
connections, or replace the cuff and
measure again.
A
Check the NIBP cuff and pump for
leakages.
A
Airway leakage is found during the
NIBP leakage test. Check the NIBP
cuff and pump for leakages.
A
The air tubing may be occluded.
Check the air tubing for an occlusion
or kinking. If the alarm persists,
contact your service personnel.
A
The patient's pulse is weak or the
cuff is loose. Check the patient's
condition and replace the cuff
application site.
A
Check the patient's condition and
reduce patient motion.
A
The cuff type mismatches the
patient category. Verify the patient
category or replace the cuff if
necessary. If patient category is
correct, check that the tubing is not
bent and the airway is not occluded.
A
The NIBP airway may be occluded.
Check the airway and measure
again. If the alarm persists, contact
your service personnel.
A
The measured NIBP value exceeds
the module measurement range.
Check the patient's condition.
D - 7
D.2.5 CO2 Technical Alarm Messages
Alarm message CO2 Module High Temp
CO2 Zero Failed CO2 Airway Occluded
XX Overrange CO2 No Adaptor
Default priority Low
Low Low
Low Low
Indication on alarm reset
Cause and solution
C
Ambient temperature is too high or
there is a module failure.
1. Lower the operating temperature.
2. If the alarm persists, the CO2
module may fail, contact your service
personnel.
C
Try to zero the module again. If the
alarm persists, contact your service
personnel.
C
1. Check if the sample line is kinked
or occluded.
2. Replace the sample line.
3. If the alarm persists, contact your
service personnel.
C
The measured value exceeds the
module measurement range. Check
the patient's condition.
B
Check the adaptor connection.
D.2.6 EWS Technical Alarms
Alarm message
Default priority
Indication on alarm reset
Cause and solution
EWS param XX is Low
A
timeout
EWS score needs Low
A
to be confirmed
The manually input parameter is timeout. Input a parameter numeric again.
Confirm to save or give up current score.
Note: XX represents RR, SpO2, Supp. O2, Temp, BP, Consciousness, Blood Sugar etc.
D - 8
D.2.7 Power Supply Technical Alarm Messages
Alarm message Low Battery
Default priority
Med
Critically Low Battery
High
Battery Service Required
Power Board Comm Error
Low High
Battery Error
High
Battery Charging Error
High
Battery Temperature Too High
Battery Off
High High
RT Clock Need Reset
High
RT Clock Not Exist High
Indication on Cause and solution alarm reset
C
Connect the monitor to an AC
power source and allow the
batteries to charge.
C
Connect the monitor to an AC
power source and allow the
batteries to charge.
B
The battery reaches its lifetime.
Replace the battery.
C
Restart the monitor. If the alarm
persists, contact your service
personnel.
C
The battery may fail. Contact your
service personnel.
C
The charging circuit fails or the
battery fails. Contact your service
personnel.
C
Stop using the monitor after this
alarm appears, and contact your
service personnel.
C
Restart the monitor. If the alarm
persists, contact your service
personnel.
C
Contact your service personnel.
C
Contact your service personnel.
D - 9
D.2.8 Technical Alarm Messages Related to Networked Monitoring
Alarm message
CMS/eGW Disconnected
WLAN IP Address Conflict LAN1 IP Address Conflict Fail To Get WLAN IP Address
Fail To Get LAN1 IP Address
Default priority
Indication on alarm reset
Cause and solution
Low
B
Low
C
Low
C
Low
C
Low
C
The monitor is disconnected from the CMS/eGateway. Check the network connection.
Wireless network IP network conflicts. Check the network settings.
Wired network LAN1 IP network conflicts. Check the network settings.
Unable to automatically obtain the wireless network IP address. Check the network settings.
Unable to automatically obtain the wired network LAN1 IP address. Check the network settings.
D.2.9 Other System Technical Alarm Messages
Alarm message
Default priority
Indication on Cause and solution alarm reset
Storage Error
High
C
The patient data Med
B
storage space is
nearly full. Please
delete some
discharged
patients.
The storage card fails or files are damaged. Restart the monitor to format the storage card. If the alarm persists, contact your service personnel.
Delete unnecessary earlier discharged patient.
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D - 11
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E Abbreviations
AAMI AC ADT Adu AVPU CE CISPR CMOS CMS COPD DC Dia DPI EEC EMC EMI EMR GCS IABP ID I:E IEC
ISO IEEE IP IPS LED MDD MetHb MEWS
Association for Advancement of Medical Instrumentation alternating current Admit/Discharge/Transfer adult Alert, Reacting to Voice, Reacting to Pain, and Unresponsive Conformité Européenne International Special Committee on Radio Interference complementary metal oxide semiconductor central monitoring system Chronic Obstructive Pulmonary Disease direct current diastolic dot per inch European Economic Community electromagnetic compatibility electromagnetic interference Electronic Medical Record Glasgow Coma Scale intra-aortic balloon pump identification inspiratory time: expiratory time ratio International Electrotechnical Commission
International organization for standardization Institute of Electrical and Electronic Engineers internet protocol Individual Parameter Score light emitting diode Medical Device Directive methemoglobin Modified Early Warning Score
E - 1
MRI N/A Neo NEWS NIBP NIBP-D NIBP-M NIBP-S P PD Ped Pleth PR RAM ROM SpO2 TD TEMP
magnetic resonance imaging not applied neonate National Early Warning Score noninvasive blood pressure NIBP-diastolic pressure NIBP-mean pressure NIBP-systolic pressure power photodetector pediatric plethysmogram pulse rate random access memory read-only memory arterial oxygen saturation from pulse oximetry temperature difference temperature
E - 2
F Declaration of Conformity
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P/N: 046-020097-00(4.0)
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