Spengler MASTER PALM 2 AND 3 Handheld Pulse Oximeter User Manual

User Manual for Spengler models including: 150338, master-palm-2, MASTER PALM 2 AND 3 Handheld Pulse Oximeter, MASTER PALM 2 AND 3, Handheld Pulse Oximeter, Pulse Oximeter, Oximeter

150338-master-palm-2-spengler-user-manual

Spengler MASTER PALM 2 AND 3

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150338-master-palm-2-spengler-user-manual

Spengler MASTER PALM 2 AND 3®
Handheld pulse oximeter User's manual
· · 1:11111 CE 0123
WWW.SPENGLER.FR

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Product Information · Product Name: MASTER PALM 2 and 3®

· Product Type: Handheld pulse oximeter

· Product Model: MBOO, configuration Sl or S2

· Manufactured for : SPENGLER

· After Service Contact Information:

SPENGLER SAS

30 rue Jean de Guiramand

13290 Aix en Provence

France

Mail : sav@spengler.fr

Revision History
This manual has a revision number. This revision number changes whenever the
manual is updated due to software or technical specification change. Contents of this manual are subject to change without prior notice. · Document No.: NU_MASTERPALM2-3_1vG_25O619_FREN · Revision number: G · Release time: 2019.06

Statement
Manufacturer holds the copyright of this manual, and we are also entitled to deal with this manual as confidential files. This manual is only used for operation, maintenance and service of product, someone eise can not publish the manual. This manual contains exclusive information protected by copyright laws and we reserve its copyright. Without written approval of manufacturer no parts of this manual shall be photocopied, xeroxed or translated into other languages. The contents contained in this manual are subject to amendments without
notification.

CE
0123

Distributed by Spengler SAS
.uJI Guangdong Biolight Meditech Co., Ltd. - No.2 Innovation First Road, Technical Innovation Coast, Hi-tech
Zone, Zhuhai, P.R.China
EC Representatlve Shanghai International Holding Corp. GmbH (Europe) Eiffestrasse 80, 20537, Hamburg, Germany

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Manufacturer's Responsibility

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Only under the following circumstances will manufacturer be responsible for

the safety, reliability and performance of the instrument:

· All the installation, expansion, readjustment, renovation or repairs are

conducted by the personnel certified by manufacturer.

· The storage condition, operation condition and electrical status of the

instrument conforms to the product specification.

· The instrument is used in accordance with the user's manual.

About this manual 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 an integral part of the product. lt should always be kept close to the equipment so !hat it can be obtained conveniently when needed. All illustrations in this manual serve as examples only. They may not necessarily reflect the setup or data displayed on your product.

Conventions : · Sold Italic text is used in this manual to quote the referenced chapter or
sections. · [ l is used to enclose screen texts. · - is used to indicate operational procedures.

Signs in this manual:

m Warning: lndicates a potential hazard or unsafe practice !hat, if not

avoided, will result in death or serious injury.

gcaution:
# Note:

lndicates a potential hazard or unsafe practice !hat, if not avoided, could result in minor personal injury or product/ property damage.
Provides application tips or other useful information to ensure !hat you get the most from your product.

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CONTENTS

Chapter 1 General lntroduction

1.1

lntended Use

1.2

Main Unit

1.3

Display Views

Chapter 2 Safety

2.1

Safety Information

2.2

Explanation of Symbols

Chapter 3 Basic Operations

3.1

Unpacking and Checking

3.2

Getting Started

3.3

Starting the monitor

3.4

General Setup

3.5

Date and Time Setup

3.6

Selecting the Work Mode

3.7

Selecting Patient Type

3.8

Entering/Exiting the Demo Mode

3.9

Changing the Language

3.10

Checking the Version

3.11

Selecting the Screen Maintenance

3.12

Restoring the Factory Configuration

3.13

Shutting off the Monitor

Chapter 4 Alarm

4.1

Alarm Categories

4.2

Alarm Levels

4.3

Alarm lndicators

4.4

Alarm Status Symbol

4.5

Alarm Tone Configuration

4.6

Pausing the Alarm Tones

4.7

Setting the alarm silence

4.8

Shutting off the Alarm Volume

4.9

When an Alarm Occurs

Chapter 5 Measuring Sp02

5.1

lntroduction

5.2

Safety Information

5.3

Monitoring Procedure

5.4

Sp02 Display

5.5

PR Display

5.6

Sp02 Alarm Setup

Chapter 6 Reviewing

6.1

lntroduction

6.2

Reviewing Screen

6.3

Reviewing Setup

Chapter 7 Battery

7.1

lntroduction

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7.2

lnstalling Batteries

7.3

Charging the Lithium Ion Battery

7.4

Optimizing Battery Performance

7.5

Checking the Lithium Battery

7.6

Disposing of the Batteries

Chapter 8 Maintenance and Cleaning

8.1

lntroduction

8.2

Seasonal Safety Checking

8.3

Cleaning the Monitor

8.4

Cleaning Sp02 Sensor

8.5

Disposal

Chapter 9 Accessories

100

9.1 Sp02

100

Appendix A Product Specifications

100

A.1

Safety Specifications

101

A.2

Physical Specifications

101

A.3

Environmental Specifications

101

A.4

Charging Specifications

102

A.5

Hardware Specifications

103

A.6

Data Storage

104

A.7

USB Communication

105

A.8

Measurement Specifications

105

Appendix B EMC

107

Appendix C Factory Defaults

113

C.1

Alarm Setup

113

C.2

System Setup

113

C.3

Sp02 Setup

113

C.4

Trend Setup

113

Appendix D Alarm Message

114

D.1

Physiological alarm

114

D.2

Technical alarm

114

Appendix E Warranty Registration Card

115

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Chapter 1 General lntroduction

1.1 lntended Use

MASTER PALM 2 and 3® handheld pulse oximeter is intended for continuously
monitoring or spot checking of SpO2 and PR signals of single adult, pediatric and neonatal patient.

This device can be used in institutions or units with health care capability. For instance, outpatient departments, emergency rooms and departments of internal medicine in hospitals, and ordinary departments in clinics, nursing hospitals and medical institutions for communities as well as harne care.

1.2 Main Unit 1.2.1 Front View

3 5 9

-·-

7 4 6 8

Figure 1-1 Front view of the monitor

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1/ Alarm indicating lamp

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When an alarm occurs, this lamp will light up as defined below:

· High level alarm: the lamp quickly flashes red.

· Medium level alarm: the lamp slowly flashes yellow.

· Low level alarm: the lamp lights yellow without flashing.

2/ Display screen

3/ Left button Press this button to: · Enter the main menu under the monitoring screen. · Select the highlighted menu item under the menu screen.

4/ Right button Press this button to: · Change the screen display among Big Numerics mode, SpO2 waveform mode
under the monitoring screen. · Exit current menu under the menu screen.

5/ Alarm pause button · lt's invalid to press this button when the alarm volume is off. · lt can pause the alarm for 120s when the alarm volume is on. · lt can change the alarm message to prompt message when "Lead oll" or
"Sensor oll" alarm happens.

6/ Power button After the batteries are installed: · Press this button to turn an the monitor. · Press and hold it for 2 seconds to turn the monitor oll.

7/ Up button Press this button to: · Raise the beat volume under the monitoring screen. · Move the cursor upwards or increase the value of selected menu item under
the menu screen.

8/ Down button Press this button to: · Lower the beat volume under the monitoring screen. · Move the cursor downwards or decrease the value of selected menu item.

9/ Battery charging indicating lamp · Lights orange when the battery is being charged. · ls shut oll when the battery is fully charged or not being charged.

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1.2.2 Rear View

1. Speaker 2. Battery door
1.2.3 Side View Topside:
3 2

Fig 1-2 Rear view of the monitor Downside:
4 ------

Leftside:
1

Fig 1-3 Side view of the monitor

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1. SpO2 probe/ Communication connector

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2. ECG cable connector (not for this version)

3. Cord hold

4. Power supply connector

lt is used to connect the charger stand.

1.3 Display Views This device has a function of automatic display rotation (Gravity Activated) which provides for vertical and horizontal positioning to maximizing space utilization and visibility.

1.3.1 Big Numerics Display Mode

W120,

1S0p002 (%)

;

.,sp02 Too Lo\\

R (bpm)

750
::

2 io:o 11 13: 9

Shif

11
Flg 1-4 Blg numerlcs dlsplay mode

1. Menu: After startup, [Menu) shown here is functions of the left button. At the time, press the left button to enter [Menul
2.Patient ID No.: When [Continuous) is selected for work mode, the value is 0 at all times; when [Spot-Check) is selected, the value is between 1 and 99.
3. PR parameter area: PR parameter and its high and low alarm limits are shown in the area.
4. Physiological alarm area: Current physiological alarm information is shown in the area.
5. SpO2 parameter area: Current SpO2 value and its high and low alarm limits are shown in the area.
6.Technical alarm and prompt information area: Current technical alarm and prompt information are shown in the area.

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7. Alarm status area: Alarm status symbols and alarm pause time are shown in

the area.

8. Pleth bar: Pulse intensity is denoted by the quantity of blocks.

9. System time: Current time is shown in the area.

10. Shift: After startup, [Shift] shown here is functions of the right button. At the

time, press the right button to shift between different display modes.

11. Battery symbol: The symbol indicates the current quantity of electricity of

batteries.

1.3.2 SpO2 Waveform Display Mode

Flg 1-5 SpO2 waveform dlsplay mode
1. SpO2 waveform area: The waveform shown in the area is current SpO2 volume curve.
2. SpO2 parameter area: The values shown in the area are current SpO2 value and its upper and lower alarm limits.
3. PR parameter area: The values shown in the area are current PR value and its upper and lower alarm limits.
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Chapitre 2 Securite

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2.1 Safety Information

Warning:
· Explosion hazard: Do not use the monitor in the presence of flammable anesthetics mixture with air, oxygen, or hydrogen.
· When the monitor is in use, there should not be any great power appliances as high voltage cables, X·ray machine, ultrasound equipment and electrizer in use nearby.
· Keep the monitor away from dust, vibration, corrosive substances, explosive materials, high temperature and moisture.
· The monitor is not designed for the sterilized room.
· The monitor should be handled with care so as to avoid shocks and falls.
· Do not use this device during defibrillation.
· Do not use this device to monitor a paced patient.
· When the monitor is in use, it must be ensured the batteries have sufficient capacity; otherwise there might be such phenomena as starting-up abnormalities or inaccurate measurement data, etc.
· Do not conduct Sp02 measurement on the finger smeared with nail polish; otherwise this will lead to unreliable measurement results.
· Measurements and pulse signals can be affected by certain environmental conditions, sensor application errors, and certaln patlent condltlons. See the approprlate sectlons of this manual for specific safety information.
· The use of accessorles, sensors, and cables other than those specified may result in increased emission, low anti disturbance and/or create invalid readings of the monitor. lt is advised to check it at least once a month.

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· The monitor can only monitor one patient at a time.
· In order to have more accurate measurements results, the monitor should be used in quiet and comfortable environment.
· To guarantee the normal and safe operation of the monitor, a preventive check and maintenance should be conducted for the monitor and its parts every 6 to 12 months (including performance check and safety check) to verify the instrument can work in a safe and proper condition and it is safe to the medical personnel and the patient and has met the accuracy required by clinical use.

2.2 Explanation of Symbols

Symbol
{!}

Symbol Note Type BF applied part without defibrillation-proof

mi -- --- --
IPX1
?&

Attention: Consult accompanying documents (this manual).
Direct Current (DC) Degree of protection against ingress of liquid
Alarm volume off

'
M

Alarm volume pause parameter alarm off

Beep volume off

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-...Symbole

Explication du symbole Power supply connector Left/right button Up button

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T
·

Down button Date of manufacture Manufacturer

CE mark

0123

!SN!

Serial number

0/@
SpO,
:a

Power button Short for "Pulse Oxygen Saturation" Symbol for the marking of electrical and electronics devices according to Directive 2002/96/EC .

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Chapter 3 Basic Operations

3.1 Unpacking and Checking

Open the package. In the package are parts as follows.

Take out the monitor and its accessories.

Parts SpO, probes (DB9 plugs) AA battery
User's manual
QC certificate
Packing list
Lithium battery
AC-DC adapter USB to DB9 connector Battery charger
Protective cover
Carrying case

Standard

Optional

Quantity 1 3
this manual 1 1 1 1 1 1 1 1

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3.2 Getting Started

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1. Before you start to make measurements, carry out the following checks an the

monitor including all connected modules.

- Check for any mechanical damage;

- Check for any incorrect connection of all the external cables and accessories.

2. Put batteries into the battery compartment. Make sure !hat the battery has sufficient power for monitoring. When you use a lithium battery for the first time, you must charge it, following the instructions given in Battery chapter.

Warning:
· Warning: lf the monitor is mechanically damaged, or if it is not working properly, do not use it for any monitoring procedure on a patient. Contact your service personnel.
· To avoid explosion hazard, do not use the monitor in the presence of flammable anesthetics, vapors or liquids.

3.3 Starting the monitor
Press the button Ö /®to turn an the monitor. The alarm indicating lamp flashes, and then goes out. The system gives a beep and enter the main screen. For you to use the monitor more conveniently, after starting the monitor you can make the following setting as shown in section 3.4 first.
3.4 General Setup
Press the Left button to enter [Menul then select [General Setup] to enter the general setup menu shown as follows. You can sei the following parameters' values.

Fig 3-1 General setup window
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3.4.1 Beep Volume Setup

Press the Left button to select the item. then set its value through the Up or
lEJ: Down button. You can select from O to 4. A sign of will be shown at the

bottom of the monitoring screen.

3.4.2 Key Volume Setup
Press the Left button to select the item, then set its value through the Up or Down button. You can select from O to 4.

3.4.3 Adjust the Screen Brightness
Press the Left button to select the item, then set its value through the Up or Down button. You can select from 1 to 5. Selecting the minimum brightness can save power.

Caution: lf the monitor is used outdoors or the ambient light is strong, set the screen brightness to a higher level.

3.4.4 Scan Speed Setup Press the Left button to select the item, then set its value through the Up or Down button. You can select from 12.5mm/s to 25mm/s.
3.5 Date and Time Setup After starting up, you need to set date and time of this monitor. Operations are as follows: 1. Select [Menu] - [System] to enter the System menu shown as follows:

------=-:r.nr'

= ·

ll11Lc,

09 ll lO

Ti rnc,

l l : O(i

Type,

!\du

\I:.inkn:,nce

l.oad De fau I t C:on f.

s·;.-.,.,t.

,Return 1

Fig 3-2 System setup window

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2. Select the year, month and day on the right of [Date] , and set them to the

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current date.

3. Select the hour and minute on the right of [Time] and set them to the current time.

3.6 Selecting the Work Mode The monitor is designed to operate in the continuous monitoring and spot checking mode. lts work mode is shown in the technical alarm area. You can set the monitor's work mode as following steps:
1. Select [System] - [Maintenance], a password entering window will pop up, input the password and select [OK] to enter the maintenance window shown as follows:

Fig 3-3 Maintenance window
2. Select [Work Model, you can set the monitor's wok mode to [Continuousl or [Spot-Check]. 3.6.1 Continuous Monitoring Mode The continuous monitoring mode is intended for long-term monitoring. This mode is normally selected when the patient is in hospital or under transport. At the time, the patient ID defaulted by the system is 0. When the memory reaches the above limit, the data stored primarily will be cleared.
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3.6.2 Spot-checking Mode

Spot-checking mode is intended for short-term on-site measurement. This mode

is normally selected to check outpatient when doctors make rounds of the

wards. The patient ID will automatically increase from 1 to 99 according to the

connecting of SpO2 sensor. Details are as follows:

Apply the SpO2 sensor to the patient.

After valid signals are detected.

1. The patient ID flashes and automatically increases by 1 after 8 seconds to admit a new patient.

2. Press the Left button when the current patient ID is flashing, the patient ID will stop flashing and remain unchanged. The patient will not be admitted and new measurements will be stored under the current patient ID.

3. When the storage of patient measuring data reaches its limit, the newly measuring data will cover for the primary one.

Caution: Only when the monitor isn't monitoring any patient, connecting its Sp02 sensor to a patient, the patient ID will add 1 automatically.

3.7 Selecting Patient Type To select the patient type, 1. Select (Menu] - (System] - (Type]. 2. Set (Type] to (Adu] (adult), (Ped] (child) or (Neo] (neonate).
3.8 Entering/Exiting the Demo Mode To enter the demo mode: 1. Select (Menu] - (System] - (Maintenancel - enter the required password. 2. Set [Screenl to [Demo] and the message [Demo Model is shown in the technical alarm area. To exit the demo mode: 1. Select (Menu] - (System] - [Maintenance] -enter the required password. 2. Set [Screen] to [Normal].

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Caution: The Demo mode is for demonstration purpose only. To avoid that the simulated data are mistaken for the

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monitored patient's data, you should not enter the Demo

mode during a patient is being monitored. Otherwise,

improper patient monitoring and delayed treatment could

result.

3.9 Changing the Language Select [Menu] - [System] - [Maintenance], enter the required password. Select [Factory Setup] to set [Languagel
3.10 Checking the Version Select [Menu] -[System] -[Maintenance] , enter the required password. Select [Factory Setup] to check the version of the monitor.
3.11 Electing the Screen Maintenance Select [Menu] -[System] -[Maintenance].enter the required password. Select [ Factory Setup] -[Screen Maintenance]. set [DspSwitch] to [On] or [Off]. lf you select [On]. the screen can react to the gravity. When the monitor rotates, the screen will rotates the display direction automatically.

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3.12 Restoring the Factory Configuration

II you have changed the system's configuration and want to restore the lactory

configuration, follow this procedure:

1. Select (Menu] - (System].

2. Select (Load Default Conf.], popping up a confirming window, select (OK] to restore the lactory configuration,,

3.13 Shutting off the Monitor
Please follow the below steps to shut oll the monitor: 1. Conlirm that the patient monitoring is finished. 2. Disconnect the SpO2 sensors form the monitor. 3. Press the power button and hold it for 2s to turn oll the monitor.

Caution: Under the Spot-check mode, if the monitor is not in use and there is no button operation for more than S minutes, the monitor will shut down automatically.

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Chapter 4 Alarm

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Alarm refers to a prompt !hat is given by the monitor for medical personnel through visual, audible and other means when a vital sign appears abnormal or the monitor occurs technical problem.

Note: The monitor generates all the audible and visual alarms through speaker, alarm lamp and screen.

4.1 Alarm Categories By nature, the pulse monitor's alarms can be classified into three categories: 1. Physiological alarms Physiological alarms are triggered by a monitored parameter value !hat violates set alarm limits or an abnormal patient condition. Physiological alarm message are displayed in the physiological alarm area.
2. Technical alarms Technical alarms are triggered by a device malfunction or a patient data distortion due to improper operation or system problems. Technical alarm messages are displayed in the technical alarm area.
3. Prompt messages As a matter of fact, prompt messages are not alarm messages. Apart from the physiological and technical alarm messages, the pulse monitor will show some messages telling the system status. Prompt messages are displayed in the technical alarm area.
4.2 Alarm Levels 1. By severity, the pulse monitor's physiological alarms can be classified into three
categories: high level alarms, medium level alarms and low level alarms. - High level alarms lndicate !hat the patient is in a life threatening situation and an emergency treatment is demanded. - Medium level alarms lndicate !hat the patient's vital signs appear abnormal and an immediate treatment is required.
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- Low level alarms

lndicate !hat the patient's vital signs appear abnormal and an

immediate may be required.

2. By severity, the pulse monitor's technical alarms can be classified into two categories: medium level alarms and low level alarms.

Caution: The level of technical alarm can't be changed by the user.

4.3 Alarm lndicators When an alarm occurs, the pulse monitor will indicate it through the following indications:
- Alarm tone: According to alarm level, speaker in the monitor gives alarm sound in different tone.
- Alarm lamp: According to alarm level, alarm lamp on monitor flashes in different color and speed.
- Alarm message: Alarm messages are displayed on the screen.
- Flashing numeric: The numeric of parameter in alarm flashes.

Caution: For different alarm levels, the alarm lamp, alarm tone and alarm messages presented are different.

4.3.1 Alarm tone
The different level alarms are indicated by the system in following different audio ways:

Alarm level High Medium Low

Audible prompt "D0-D0-D0------D0-D0, D0-D0-D0------D0-D0" "D0-DO-DO" "D0-"

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4.3.2 Alarm Lamp

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When an alarm occurs. the alarm levels are indicated in the following different

visual ways:

Alarm level High Medium Low

Visual prompt Alarm lamp flashes in red with 2 Hz. Alarm lamp flashes in yellow with 0.5 Hz. Alarm lamp lights on in yellow without flashing.

Caution: · When multiple alarms of different levels occur at the same
time, the monitor will select the alarm of the highest level and give visual and audible alarm indications. · When multiple alarms occur at the same time, the alarm message will be displayed in the alarm area in turn.

4.3.3 Alarm Message When an alarm occurs, the alarm message will be displayed in the alarm area. · The system uses the following symbols to match the alarm level of physiological
alarm messages: High level alarms: ... Medium level alarms: ** Low level alarms: ·
· The system uses different background colors for the alarm message to match the alarm level:
High level alarms: red Medium level alarms: yellow Low level alarms: yellow
4.3.4 Flashing Numeric When a physiological alarm occurs, the numeric of parameter flashes.
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4.4 Alarm Status Symbol

indicates the alarm sound is turned off.

indicates the alarm sound is paused.

indicates individual measurement alarms are turned off.

4.5 Alarm Tone Configuration 4.5.1 Setting the minimum Alarm Volume 1. Select [Menu) - [System) - [Maintenance) - enter the required password. 2. Select [Min.Alm.Vol.) and then select a value between O and 4.

4.5.2 Changing the Alarm Volume 1. Select [Menu) - [General Setup). 2. Select [Alarm Vol.) and then select a value between Xand 4. Xis the minimum
volume which depends on the setting of the minimum alarm volume.

4.6 Pausing the Alarm Tones Press the alarm pause button to keep the alarm paused for 120 seconds. And there will be alarm paused symbol and paused time shown in the alarm status.
· The audible alarm is paused, but the alarm lamp remains lit and the alarm message remains displayed;
· The remaining alarm pause time is displayed in the alarm status area; · The symbol is displayed in the alarm status area.
Audible alarm starts again automatically alter the alarm pause period expires. You can also press the key to restart the audible alarm.
4.7 Setting the alarm silence Press the alarm pause button for 2 seconds to make the alarm silence. You can restart the audible alarm by pressing this button again. During the alarm silence, if there is a new alarm occurs, the monitor will restart the audible alarm. This symbol will be displayed on the screen upright the monitor.

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4.8 Shutting off the Alarm Volume

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Set the [Min.Alm.Vol.J and [Alarm Vol.J to O to shut oll the alarm volume. Then there will be a symbol shown in the alarm status area. The alarm lamp and

alarm messages are still active after the alarm volume is off. The audible alarm is

reactivated automatically when:

· The factory configuration is loaded;
· Set the alarm volume to a nonzero value.
When a factory configuration is selected, the alarm volume of the monitor may be lower than the minimum alarm volume. In this case the alarm volume is automatically adjusted according to the minimum alarm volume.

Warning: · When the alarm sound is switched off, the monitor will
give no audible alarm tones even if a new alarm occurs. Therefore the user should be very carefully about weather to switch off the alarm sound or not.
· Don't rely exclusively on the audible alarm system for patient monitoring. Adjusting alarm volume to a low level may result in a hazard to the patient. Always keep the patient under close surveillance.

4.9 When an Alarm Occurs
Note: When an alarm occurs, you should always check the patient's condition first.
Check the alarm message appeared on the screen. lt is needed to identify the alarm and action appropriately, according to the cause of the alarm.
1. Check the patient's condition. 2. ldentify alarming parameter and alarm category. 3. ldentify the cause of the alarm. 4. Silence the alarm, if necessary. 5. When cause of alarm has been over, check that the alarm system
is working properly. You will find the alarm messages for the individual parameter in Appendix D Alarm message.
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Chapter 5 Measuring SpO2

5.1 lntroduction

The measurement of oxygen saturation of arterial blood (also known as pulse oxygen saturation, usually shortened as Sp02) adopts the principles of light spectra and volume tracing. The LED emits lights with two specific wavelengths, which are selectively absorbed by oxygenated hemoglobin and deoxyhemoglobin. The optical receptor measures the changes in the light intensity after the light passes the capillary network and estimates the ratio of oxygenated hemoglobin and the total hemoglobin.

oxygenated hemoglobin oxyhemoglobin + deoxyhemoglobin

x100%

Wavelengths of the light emitted by the pulse oximeter probe are nominally 660nm for red LED and g4onm for infrared LED.

5.2 Safety Information

Warning: · Use only SpO2 sensors specified in this manual. Follow
the SpO2 sensor's instructions for use and adhere to all warnings and cautions. · When a trend toward patient deoxygenation is indicated, blood samples should be analyzed by a laboratory co-oximeter to completely understand the patient's conditions. · Do not use the monitor and the SpO2 sensor during magnetic resonance imaging (MRI). lnduced current could cause burns. · Prolonged continuous monitoring may increase the risk of unexpected changes in skin characteristics, such as irritation, reddening, blistering or burns. lnspect the sensor site every two hours and move the sensor if the skin quality changes. For neonates, or patients with poor peripheral blood circulation or sensitive skin, inspect the sensor site more frequently.

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Warning:

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· Check the Sp02 sensor and its package for any sign of damage before use. Do not use the sensor lf any damage

is detected.

· When disposing the disposable Sp02 probe or useless Sp02 probe, please observe all local, state, and federal
regulations that relate to the disposal of this products or

similar products.

Caution: In case it is necessary to add a clip to fix the fingertip sensor, the cable instead of the sensor itself should be clipped. Please note that the cable of sensor should not be pulled with force.

Note:
· The pleth wave is not equal to the intensity of PR signal.
· The monitor does not provide automatic self-examination alarm signal and the operator has to use Sp02 simulator for self-examination.

5.3 Monitoring Procedure
1. Selecting Sp02 Sensor Depending on the patient category. weight and application site, you can select the Sp02 sensor as required. 2. Connecting Sp02 Sensor Plug the Sp02 sensor cable into the Sp02 connector on the measurement module.
3. Applying Sp02 Sensor Clean the application site, such as colored nail polish, and apply the sensor to the patient.

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Warning:

· Do not use the Sp02 sensor on a limb where the NIBP cuff

is applied. This may result in inaccurate SpO2 readlng due to blocked blood flow during cuff inflation.

· Do not conduct SpO2 measurement on the finger smeared wlth nall pollsh, otherwlse unrellable measurement results

might be produced.

· When using finger sensor, make sure the nail faces to the

light window.

5.4 SpO2 Display · Parameter Display

Fig 5-1 SpO2 parameter Sp07 labet 2. High a/arm limit of Sp07 3. Low a/arm limit of Sp07 4. Sp07 value 5. SpO,,unit · Waveform Display
Fig 5-2 Sp02 waveform

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5.5 PR Display

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2 3
Fig 5-3 PR parameter
7. PR labe/ 2. High alarm limit of PR 3. Low alarm limit of PR 4. PR value 5. PR unit

5.6 SpO2 Alarm Setup 5.6.1 Switching On/Off Sp02 Alarm 1. Select (Menu] - (Alarm Setup]. 2. Set the (Alarm] of SpO, to (Off] to shut off SpO, alarm. When the alarm of
22'). SpO, is off, there is a sign of in the SpO, parameter display area.
5.6.2 Setting Alarm Level 1. Select (Menu] - (Alarm Setup]. 2. Set the (Alarm] of SpO, to (Medl or (High].

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5.6.3 Adjusting the Alarm Limit

1. Select [Menu] - [Alarm Setup].

2. Adjust [High] :lf the SpO2 measurement is higher than the high alarm limit, the "SpO2 Too High"" alarm will be triggered.
3. Adjust [Low] :lf the SpO2 measurement is lower than the low alarm limit, the ""SpO2 Too Low" alarm will be triggered.

5.6.4 Setting Desat Limit
SpO, desat means when SpO, measuring value is lower than the desat limit. a high physiological alarm will be trigged. lts setting is as follows:
1. Select [Menu] - [System] - [Maintenance],then pops up a password entering window.
2. Input the password and select [OK] to enter the maintenance window. Select [Desat Limit], Then set its value through the Up and Down button.

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Chapter 6 Reviewing

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6.1 lntroduction

Select [Menu] - [Trend] to enter trend reviewing window. In the window, you can review SpO2 and PR data stored before.

6.2 Reviewing Screen

D:3 Adu 10-07-19

T1nll'

S02 Hfl

U ::17 :20 98

11 ::lfi:fi() 99

.53

ll::lü:20 98

r,7

. . . .-.---';i-1 1 ll ::tfi:20 !l

fi:t

lienu

'IR<>turn

Flg 6-1 SpO/HR revlewlng wlndow

The above is SpO/HR reviewing window. In the window, you can review SpO/
HR value measured in different time. When SpO2 or HR is over the setting alarm limit, their values are red. lf the trend date is not only one page, you can turn
pages by the up/down button.

6.3 Reviewing Setup
After entering the reviewing window, press the left button to enter Setup] window shown as the following:

[Trend

lntcrval
Sclccl ID

30 sc a

Delcte Sclcctcd
Dclclc All

Export Trend

Select

Return

Flg 6·2 Trend Setup

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In the window you can set [Intervall [Select 1D], [Delete Selected], [Delete All]

and [Export Trend] :

· lnterval: Toadjust recording time interval within the range from 2 seconds to 30 minutes.

· Select 1D: To select patient 1D No. The user may change 1D No. to browse trend data of related patients.

· Delete Selected: Todelete trend data of the selected 1D No.

· Delete All : Todelete trend data of all patients.

· Export Trend : Tosend trend data of the selected 1D No. Before the operation, related computer software must be opened, and connect computer and monitor with the USB to DB9 connector. After sending all the trend data, you can check them in the computer.

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Chapter 7 Battery

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7.1 lntroduction

The handheld pulse oximeter is designed to operate on three l.SV alkaline AA batteries or a rechargeable lithium ion battery. Under normal circumstances, no special maintenance is needed.

When alkaline batteries or a lithium ion battery is used, the battery icon indicates the battery status as follows:

r- 1. lndicates that the power of the battery is full ;

lndicates that the power of the battery is 3 grids left;

3.-= lndicates that the power of the battery is 2 grids left ;

4.-= lndicates that the power of the battery is 1 grid left ;

clllllll 5.

lndicates that the battery is almest depleted.

Battery power supply can only last for a period of time. lf the voltage of batteries is too low, an alarm of "Battery Low" will be triggered. lf alkaline AA batteries are used, please change them timely; if a rechargeable battery is used, please insert the monitor to battery charger and connect the charger with commercial power to charge the battery. The monitor will be switched off automatically 10 minutes alter the first "Battery Low" alarm is given.

Caution: Remove the batteries prior to shipping or if the monitor is not likely to be used for an extended period of time.

Warnlng: · Use only batteries specified in this manual. · Keep the batteries out of children's reach. · When the monitor is not in use for a long time, the
battery should be removed from it. Dispose of battery in accordance with local ordinances and regulations.

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7.2 lnstalling Batteries

Battery compartment is at the back of the device, please follow the following

steps to install or change batteries.

7.2.1 Opening the Battery Door 1. Turn the monitor oll first. 2. Use the screw driver to loose the screw !hat secures the battery door to the
monitor.

Flg 7-1 Loose the screw

screw

3. Press the battery door, push it downwards and remove the battery door.

l
Flg 7-2 Push the battery door

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7.2.2 lnstalling the Alkaline Battery

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1. Insert the AA alkaline batteries in the battery compartment. aligning the + on

each battery with the + shown inside the battery compartment.

2. Close the battery door and push it upwards.

3. Tighten the screw that secures the battery door to the pulse monitor.

Caution: Check the batteries periodically for corrosion. Replace batteries if corrosion is present, otherwise damage to the monitor may occur.

Caution: Do not run the pulse monitor using alkaline batteries of different types or capacities at the same time.

7.2.3 lnstalling the Lithium Ion Battery

1. Insert the lithium ion battery in the battery compartment, following shown as

follows:

..... ...........

Press the battery in

Fig 7-3 lnstall the battery 2. Close the battery door and push it upwards. 3. Tighten the screw that secures the battery door to the pulse monitor.
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Warning:

· Do not use the charger stand when the alkaline batteries is

depleted or no battery is installed.

· Disconnect the monitor from the patient and stop

monitoring before charge the battery.

· When connect the running monitor to the AC-DC adapter

to charge its battery, there will be a message displayed

on the screen, and the monitor will shut down after 10

seconds.

7.3 Charging the Lithium Ion Battery -. /1.....- Handheld pulse oximeter

Battery charger

AC/DC adapter

Fig 7-4 Charging device
To charge the lithium ion battery: 1. Place the pulse monitor in the charger stand. 2. Connect the AC-DC adapter and plug the adapter into the AC mains. 3. The indicating lamp on the battery charger and the indicating lamp on the
monitor are on to indicate that the battery is in charge. 4. When the battery charging indicating lamp on the monitor turns off, the
battery is fully charged.
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7.4 Optimizing Battery Performance

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A battery needs at least two optimizing cycles when it is pul into use for the

first time. A battery cycle is one complete, uninterrupted charge of the battery,

followed by a complete, uninterrupted discharge of the battery. A battery

should be conditioned regularly to maintain its useful life. Condition a battery

once when it is used or stored for two months, or when its run time becomes

noticeably shorter.

To optimize a battery, follow this procedure:

1. Disconnect the monitor from the patient and stop all monitoring and measuring procedures.

2. Place the battery in need of optimizing into the battery compartment to the monitor.

3. Place the monitor in the charger stand and connect the AC mains. Allow the battery to be charged uninterruptedly for above 4 hours.

4. Remove the AC mains and allow the monitor to run from the battery until it shuts off.

5. Replace the monitor in the charger stand and connect the AC mains. Allow the battery to be charged uninterruptedly for above 4 hours.

6. The optimizing of the battery is over.

7.5 Checking the Lithium Battery
The performance of a battery may deteriorate over time. To check the performance of a battery, follow this procedure:
1. Disconnect the monitor from the patient and stop all monitoring and measuring procedures.
2. Place the monitor in the charger stand and connect the AC mains. Allow the battery to be charged uninterruptedly for above 4 hours.
3. Disconnect AC mains and allow the monitor to run on the battery until it shuts off.
4. The operating time of a battery reflects its performance directly.

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Caution: · The service life of battery depends on the service time

and frequency. This lithium battery can be charged and

discharged for 300 times generally.

· The operating time of a battery depends on the configuration and operation of the pulse monitor.

7.6 Disposing of the Batteries Batteries !hat are damaged or depleted should be replaced and discarded properly. Dispose of used batteries according to local regulations.
Warning: Do not disassemble batteries, or dispose of them in fire, or cause them to short circuit. They may ignite, explode, or leak, causing personal injury.

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Chapter 8 Maintenance and Cleaning

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8.1 lntroduction

Keep your equipment and accessories free of dust and dirt. To avoid damage to the equipment, follow these rules:

1. Always dilute according the manufacturer's instructions or use lowest possible concentration.

2. Do not immerse part of the equipment in the liquid.

3. Da not pour liquid onto the equipment or accessories.

4. Do not allow liquid to enter the case.

5. Never use abrasive materials (such as steel wool or silver polish), or erosive cleaners (such as acetone or acetone-based cleaners).

Warning: Be sure to shut down the system and disconnect all power cables from the outlets before
cleaning the equipment.
For optimal performance, product service should be performed only by qualified service personnel.

Caution: lf you spill liquid onto the equipment or accessories, contact your service personnel or us.

8.2 Seasonal Safety Checking
Note: To ensure the performance and safety of equipment, it must be checked after using 1 year. When check the equipment, please contact professional technology engineers.

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Please clean the plug of power cord at least once a year.

Too much dust on plug may cause the fire.

The following safety checks should be performed at least every 12 months by a qualified person who has adequate training, knowledge, and practical experience to perform these tests.

The data should be recorded in an equipment log. lf the device is not functioning properly or fails any of the following tests, the device has to be repaired.

1) lnspect the equipment and accessories for mechanical and functional damage.

2) lnspect the safety relevant labels for legibility.

3) Verify !hat the device functions properly as described in the instructions for use.

4) Test the earth leakage current according IEC 60601-1: Limit: NC S00µA, SFC: l000µA.

5) Test the enclosure leakage current according to IEC 60601-1: Limit: NC l00µA, SFC: S00µA.

6) Test the patient leakage current (normal operation) according IEC 60601-1: Limit: type CF: for a.c.: l0µA, for d.c.: l0µA.

7) Test the patient leakage current under single fault condition according IEC 60601-1: Limit: type CF: for a.c.: S0µA, for d.c.: S0µA.

8) Test the patient leakage current Mains voltage on applied part: According IEC 60601-1: Limit: type CF: for a.c.: S0uA.

Warning: No use-serviceable parts inside, before servicing to authorized representative or manufacturer.

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8.3 Cleaning the Monitor

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1. Common detergent and non-corrosive disinfectant used in hospital can be

applied to clean monitor, however you must be aware !hat many kinds of

detergents must be diluted prior to utilization, and please use it according to

the instruction of detergent manufacturer.

2. Avoid the use of alcohols, amino or acetonyl detergent.

3. The enclosure and screen of monitor shall be free of dust, and they can be wiped with lint-free soft cloth or sponge soaked in detergent. While cleaning, be careful and do not spill liquid onto the instrument and keep any liquid out of it. When wiping the side panel of monitor, you must be especially careful to keep water out of all kinds of cable and outlet on the panel.

4. Do not use abrasive material including wire brush or metal brightener during cleaning because this material will damage the panel and monitor screen.

5. Do not submerge the monitor in liquid.

6. While cable or plug of attachment accidentally gets wet, please rinse it with
distilled water or deionized water and dry it in the environment of temperature 40°C to 80°C for at least one hour.

8.4 Cleaning SpO2 Sensor
1. The casing of the sensor and light tube can be cleaned with swab or non-velvet soft cloth dipped with medical alcohol.
2. The sensor cable can be cleaned or sterilized with Hydrogen Peroxide 3% or isopropyl alcohol 70%.
3. lt is forbidden to pul the monitor in high-pressure containers and pul the sensor directly in liquid.

Warning: Do not reuse or disinfect the disposable SpO, sensor.
8.5 Disposal
Dispose of the monitor in accordance with local environment and waste disposal laws and regulations. For the disposal of SpO, sensor, follow local regulations regarding disposal of hospital waste.

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Chapter9 Accessories

9.1 Sp02

STD SpO2 sensor Type Reusable

Patient Category Adult Pediatric Neonatal

PN 222 230 222 231 222 232

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Appendix A Product Specifications

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A.1 Safety Specifications

SFDA classification
CE classification
Type of protection against electric shock
Degree of protection against electric shock
Degree of protection against hazards of explosion
Degree of protection against ingress of liquid
Equipment type

II llb 11, with internal power device
BF Ordinary equipment, without protection against hazards of explosion IPXl Handheld

A.2 Physical Specifications
Mainframe weight Mainframe size Charger weight Charger size AC-DC adapter weight AC-DC adapter size

< 400g(full configuration, including the batteries)
58.Smm(W) x123mm(H)x28mm(D) < 100 g
96mm(W)x66mm(H)x78mm(D) < 200 g 41.5mm(W)x90mm(H)x32mm(D)

A.3 Environmental Specifications

Temperature
Atmospheric pressure
Humidity

Operating: 5°C to +40°C Storage: -20°C to +55°C Operating: 700hPa to 1060hPa Storage: SOOhPa to 1060hPa Operating: 15% to 85%(non condensing) Storage: 10% to 93%(non condensing)

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A.4 Charging Specifications

A.4.1 AC-DC Adapter (Optional)

Input Output

100-240 VCA. 50/60 Hz. 0.5A SV, 1,5A

A.4.2 Battery Specification

Standard Type Capacity Voltage Quantity lndication of battery capability
Run time
Shutdown delay Optional Type Size Weight Quantity Rated voltage Capacity
Run time

1.5V, AA alkaline battery 2000mAh 1.5V DC 3
There are live status including empty , 1,2, 3and full.
> 14hours With Sp02 monitored continuously, Audio indicators oll and backlight brightness sei to minimum and using new, full power batteries at ambient tempe rature 25°C. 10min(After the first "low battery" alarm)
Lithium ion rechargeable battery 50mmx46,5mmx13,5mm 50 g
3.7 VDC 1600mAh > 14hours With Sp02 monitored continuously, Audio indicators oll and backlight brightness set to minimum and using new, full power batteries at ambient temperature 25°C.

Charge time

3hours to 90% 4hours to 100%

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Shutdown delay

l0min (After the first "low battery" alarm)

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lndication of battery capability

There are live status including empty, 1, 2, 3 and full.

Type

AA NI-MH battery

Capacity

2100 mAh

Voltage

1,2VDC

Quantity

A.5 Hardware Specifications A.5.1 Display

Type Size (diagonal) Resolution

TFT 2,4 inch 320 x 240 pixels

A.5.2 indicating LED

Mainframe LED Alarm indicating lamp
Battery charging indicating lamp
Charger LED
AC power indicating lamp

1 (Yellow/Red)
1 (orange) When charged, it lights orange. When fully charged or not charged, it does not light.
l(Green) When connecting to the AC-DC adapter, it lights green; When disconnecting from the AC-DC adapter, it does not light.

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A.5.3 Audio indicating

Speaker

Gives audible alarm, button tone and beep tone Supports Pitch Tone and multi-level volume; Alarm tones meet the requirement of IEC 60601-1-8.

Alarm pressure 45 dB to 85 dB, Testing place is 1 meter from the tone.

A.5.4 Buttons Quantity Functions

6
Power button, Up button, Down button, Left button, Right button, and Alarm pause button.

A.5.5 Sensors Wavelength

Pulse oximetry sensors contain LEDs that emit red light at a wavelength of approximately 660 nm and infrared light at a wavelength of approximately 905 nm. The total optical output power of the sensor LEDs is less than 15 mW. This information may be useful to clinicians, such as those performing photodynamic therapy.

A.6 Data Storage The changing trends of Sp02 and PR data will be shown in the monitor:

Displaying way Trend tabular

Trend interval

30 seconds to 30 minutes

Trend parameter Storage

PR, Sp02 Save when power down

Trend data

Spot-check: ID from 1 to 99, 300 groups can be stored for each ID. Continuous: ID is 0, 60000 groups can be stored.

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A.7 USB Communication

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USB to DB9 connector

In compliance with IEC 62680

Steady communication
distance

1.0 meters

A.8 Measurement Specifications A.8. 1 SpO, Specifications

Fulfill the requirement
Measurement technique
Sp02 alarm range and error
PR alarm range and error

ISO 80601-2-61
Digital Sp02 technique
50%-100%, the high and low limit is adjustable, alarm error is ±1% Obpm -250bpm, the high and low limit is adjustable, alarm error is ±1 bpm

· STD Digital SpO,
SpO2 Technic Range Resolution
Accuracy
Alarm Refreshing rate Pitch Tone

Digital Sp02 technic 0 -100 % 1%
70 % to 100 % : ± 2 % 0 % to 69 % : unspecified
Select the high and low alarm limit of Sp02 < 13 seconds
With

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Range

25 bpm to 250 bpm

Resolution

1 bpm

Accuracy

± 1 % or ± 1 bpm, whichever is the greater

Refreshing rate

< 13 seconds

A.8.2 Alarm limit specifications

Alarm limits Sp02 high limit Sp02 low limit Alarm limits PR high limit PR low limit HR high limit HR low limit

Range(%) (low limit +1) to 100 Desat to (high limit -1) Range (bpm) (low limit +1) to 250 0 to (high limit -1) (low limit +1) to 250 0 to (high limit -1)

Step (%) 1 Step (bpm) 1
1

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Appendix B EMC

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Guidance and manufacturer's declaration - electromagnetic emissions- for all EQUIPMENT and SYSTEMS

Guidance and manufacturer's declaration - electromagnetic emission

The MASTER PALM 2 and 3· Handheld pulse oximeter is intended for use in the electromagnetic environment specified below. The customer of the user of the MASTER PALM 2 and 3· Handheld pulse oximeter should assure that it is used in such and environment.

Emission test

Compliance

Electromagnetic environment guidance

RF emissions CISPRll

Group 1

The MASTER PALM 2 and 3· Handheld pulse oximeter 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 equipment.

RF emission CISPRll
Harmonie emissions IEC 61000-3-2

Class B Class A

Voltage fluctuations/ flicker emissions IEC 61000-3-3

Complies

The MASTER PALM 2 and 3® Handheld pulse oximeter is suitable for use in all establishments, other than domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes

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Guidance and manufacture's declaration - electromagnetic immunity - for all

EQUIPMENT and SYSTEMS

Guidance and manufactureJs declaration - electromagnetic immunity The MASTER PALM 2 and 3" Handheld pulse oximeter is intended for use in the electromagnetic environment specified below. The customer or the user of MASTER PALM 2 and 3" Handheld pulse oximeter should assure !hat it is used in such an environment.

lmmunity test

IEC 60601 test level

Compliance level

Electromagnetic environment - guidance

Electrostatic discharge (ESD) IEC 61000-4-2

±6 kV contact ±8 kV air

Floors should be wood, concrete or ceramic tile. lf floor are covered with synthetic material, the relative humidity should be at least 30%.

Electrical fast transient/ burst IEC 61000-4-4

±2 kV for power supply lines ±1 kV for signal line

±0,5 kV kV for power supply lines ±0,5 kVfor signal line

Surge IEC 61000-4-5

±1 kV differential mode ±2 kV comman mode

Voltage dips, short interruptions and voltage variations on power supply input lines IEC 67000-4-11

< 5 %
(> 95

%UTdip

in U,) for 0,5

cycle

< 5 % (> 95

%UTdip

in U,) for 0,5

cycle

Mains power quality should be !hat of a typical commercial or hospital environment. Mains power quality should be that of a typical commercial or hospital environment. Mains power quality should be !hat of a typical commercial or hospital environment.

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lmmunity test

IEC 60601 test level

Compliance level

Electromagnetic environment - guidance

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40% u, (60% dip
in UT) for 5 cycles

40% u, (60% dip in UT) for 5 cycles

70% u, (30% dip in UT) for 25 cycles

(<>59%5%UTdip in UT) for 5sec

<(>59%5%UTdip in UT) for 5sec

Power
frequency (50/60Hz)
magnetic field

3A/m

IEC67000-4-8

3A/m

Power frequency magnetic fields Should be at levels characteristic of a typical location in a typical commercial or hospital environment.

NOTE : U, is the a.c. mains voltage prior to application of the test level.

Guidance and manufacturer"s declaration - electromagnetic immunity - for EQUIPMENT and SYSTEMS that are not LIFE-SUPPORTING
Guidance and manufacturerJs declaration - electromagnetic immunity
The MASTER PALM 2 and 3® Handheld pulse oximeter is intended for use in the electromagnetic environment specified below. The customer or the user of MASTER PALM 2 and 3® Handheld pulse oximeter should assure that it is used in such an environment.

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lmmunity test

IEC
60601 test level

Compliance level

Electromagnetic environment guidance

Portable and mobile RF communications equipment should be used no closer to any part of the MASTER PALM 2 and 3· Handheld pulse oximeter, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter.
Recommended separation distance

Conducted RF IEC 610004-6
Radiated RF IEC 61000-4-3

3Vrms 150 kHz to 80 MHz
3V/m 80 MHz to 2.5 GHz

1 V rms 3V/m

P = 3
d [ n

d=[ El ]

80 MHz-800 MHz

d=[_EJl_]

P
800 MHz-2 5 GHz

Where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recom-
mended separation distance in metres (m).

Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey,a should be less than the compliance level in each frequency range.b lnterference may occur in the vicinity of equipment marked with the following symbol:

(((i)))

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z w NOTE 1: At 80 MHz and 800 MHz, the higher frequency range applies. NOTE 2: These guidelines may not apply in all situations. Electro magnetic propagation is affected by absorption and reflection from struc tures, objects and people.
a. Field strengths from fixed transmitters, such as base sta tions 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. Ta assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. II the measured field strength in the location in which the MASTER PALM 2 and 3® Handheld pulse oximeter is used exceeds the applicable RF compliance level above, the MASTER PALM 2 and 3® Handheld pulse oximeter should be observed to verify normal operation. lf abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the MASTER PALM 2 et 3· Handheld pulse oximeter.
b. Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
Recommended separation distances between portable and mobile RF communications equipment and the EQUIPMENT or SYSTEM - for EQUIPMENT
or SYSTEM that are not LIFE-SUPPORTING Recommended separation distances between portable and mobile RF communications equipment and the MASTER
PALM 2 and 3® Handheld pulse oximeter.
The MASTER PALM 2 and 3® Handheld pulse oximeter is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the MASTER PALM 2 and 3® Handheld pulse oximeter can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communi cations equipment (transmitters) and the MASTER PALM 2 and 3® Handheld pulse oximeter as recommended below, according to the maximum output power of the communications equipment.
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Separation distance according to frequency of transmitter

Rated maximum

Cm)

output

150KHz-80MHz 80MHz-800MHz 800MHz-2,5GHz

power of
=[:]FP transmitter d

d=[:]P

d=[;i}/p

(W)

0,01

0,35

0,12

0,23

0,1

1,11

0,37

0,74

3,5

1,17

2,33

11,1

3,69

7,38

100

11,67

23,33

For transmitters rated at a maximum output power not listed above, the recommended separation distance d in metres (m) can be estimated 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 separation distance for 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.

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Appendix C Factory Defaults

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This section lists the most important factory default settings. These settings can be adjusted and you can load the factory defaults if you need.
C.1 Alarm Setup

Alarm Setup Alarm Vol SpO2 Alarm Level PR Alarm Level

Factory Default 2 Med Med

C.2 System Setup
System Setup Beep Val Key Vol Brightness Scan Speed

Factory Default 2 2 3 25 mm/s

C.3 SpO2 Setup
SpO, Setup SpO2 High Limit SpO2 Low Limit PR Setup PR High Limit PR Low Limit

Adult 100 90 Adult 120 50

Pediatric 100 90 Pediatric 160 75

Neonate 95 90 Neonate 200 100

C.4 Trend Setup
Trend Setup lnterval

Factory Default 30 s

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Appendix D Alarm Message

This section lists some important alarm message. In the tables below, "'" means the alarm level is user-adjustable.

D.1 Physiological alarm

Messages SpO, Too High· SpO2 Too Low* SpO, Desat PR Too High· PR Too Low· No Pulse

Cause
A measurement has risen above the high alarm limit or fallen below the low alarm limit.
SpO, measurement has fallen below the SpO, desat limit.
A measurement has risen above the high alarm limit or fallen below the low alarm limit.
The pulse signal was too weak to be analyzed.

Level Medium High Medium High

D.2 Technical alarm

Messages Sensor Off

Cause
The SpO, sensor detached the patient or the monitor.

Battery Low

The battery power is low.

Level Medium

SpO, Low Perf

The signal detected is weak.

Distributed by Spengler SAS
..._..,J Guangdong Biolight Meditech Co., Ltd.
- No.2 Innovation First Raad, Technical Innovation Coast, Hi-tech Zone, Zhuhai, P.R.Ch1na
EC Representatlve Shanghai International Holding Corp. GmbH (Europe) Eiffestrasse 80, 20537, Hamburg, Germany
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Spengler

@
Spengler
Date de 1"' marquage CE: 25/03/2010 1st CE marking date: 2010/03/25

References

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