Instruction Manual for LifeSignals models including: LX1550E, Multi Parameter Remote Monitoring Platform, LX1550E Multi Parameter Remote Monitoring Platform, Remote Monitoring Platform, Monitoring Platform
File Info : application/pdf, 23 Pages, 422.07KB
DocumentDocumentDHF08-LBL-007
Issued by: R&D
Approved: 28/03/2022 09:19 Saravanan B
Instructions For Use (Clinician) LX1550E
Approved: 29/03/2022 09:19 Yvonne Gunning
Effective Date: 29/03/2022 Rev. E Pg. 1 of 23
Approved: 28/03/2022 11:51 Krithika Balu - Quality Assurance
Multi-parameter Remote Monitoring Platform (LX1550E)
Instructions for Use (Clinician)
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Published on: March 24, 2022 Document ID: 1000001390D
Copyright Copyright © 2021 LifeSignals, Inc. All Rights Reserved. Contains information owned by LifeSignals, Inc. and/or its affiliates. Do not copy, store, transmit or disclose to any third party without prior written permission from LifeSignals, Inc. Other product and company names may be trademarks or registered trademarks of other companies and are the property of their owners. They are used only for explanation, without intent to infringe.
Patent Protection LifeSignalsTM, LifeSignals, and LifeSignals Enabled are trademarks of LifeSignals, Inc. All product names, brands, logos, and trademarks are the property of their respective owners. For more information, see https://lifesignals.com/patents/
Intended purpose This manual describes the intended use of the Multi-parameter Remote Monitoring Platform (LX1550E), and observance of the manual is a prerequisite for proper performance, correct operation and ensures patient and user safety. The intended audience is clinical professionals who are expected to have a working knowledge of medical procedures, practices, and terminology to provide patient care.
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Table of Contents
1. Intended Use / Indications for Use
5
2. Contraindications
5
3. Product Description
5
3.1 LifeSignals Multi-parameter Biosensor
5
3.2 Relay Application
6
3.3 LifeSignals Secure Server
6
3.4 Remote Monitoring Dashboard / Web UI
7
4. Warnings
7
5. Precautions
8
6. Cybersecurity Controls
8
7. For Optimal Results
9
8. LED Status Indicators
9
9. Configuring the Mobile Phone / Tablet as a Relay Device
10
10. Start Monitoring
10
10.1 Perform Skin Preparation
10
10.2 Assign Biosensor to the Patient
11
10.3 Connect Biosensor
11
10.4 Apply Biosensor
12
10.5 Confirm and Start Monitoring Session
12
11. Report Symptoms during Monitoring
12
12. End of Monitoring
13
13. Advice for Patients
13
14. Inform your Patient
14
15. Troubleshooting Alerts Relay App
14
16. Additional Features Relay App
15
17. Appendix
16
17.1 Table 4. Technical Specifications
16
17.2 Table 5. Relay Application Messages
18
17.3 Table 6. Guidance and Manufacturer's Declaration Electromagnetic Emissions
19
17.4 Table 7. Guidance and Manufacturer's Declaration Electromagnetic Immunity
19
17.5 FCC Statement
19
17.6 Table 8. Symbols
20
17.7 Contact Information
22
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1. Intended Use / Indications for Use
The LifeSignals Multi-parameter Remote Monitoring Platform is a wireless remote monitoring system intended for use by healthcare professionals for the continuous collection of physiological data at home and in healthcare settings. This shall include Electrocardiography (2-channel ECG), Heart Rate, Respiration Rate, Skin Temperature and Posture. Data is transmitted wirelessly from LifeSignals Biosensor to Remote secure server for display, storage and analysis.
The LifeSignals Multi-parameter Remote Monitoring Platform is intended for non-critical, adult population.
The LifeSignals Multi-parameter Remote Monitoring Platform can include the ability to notify healthcare professionals when physiological parameters fall outside the set limits and to display multiple patient physiological data for remote monitoring.
Note: The terms Biosensor and Patch are used interchangeably throughout this document.
2. Contraindications
The Biosensor is not intended for use on critical care patients. The Biosensor is not intended for use on patients with any active implantable devices such as defibrillators or pacemakers.
3. Product Description
The LifeSignals Multi-parameter Remote Monitoring Platform contains four components: LifeSignals Multi-parameter Biosensor - LP1550E (referred to as "Biosensor") LifeSignals Relay Device - LA1550-RA (Application Part Number) LifeSignals Secure Server - LA1550-S (Application Part Number Web Interface / Remote Monitoring Dashboard LA1550-C
3.1 LifeSignals Multi-parameter Biosensor
The Biosensor is based on LifeSignals' proprietary semiconductor chip (IC), LC1100, that has a fully integrated sensor and wireless systems. The LX1550E Biosensor supports WLAN (802.11b) wireless communications.
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(1. Right Upper electrode 2. Left Upper electrode 3. Right Lower electrode 4. Left Lower electrode)
Figure 1. Wearable Biosensor
The Biosensor acquires physiological signals, pre-processes and transmits as two channels of ECG signals (Fig. 2 Channel 1: Right Upper electrode Left Lower electrode and Channel 2: Right Upper electrode - Right Lower electrode), TTI respiration signals (one of the inputs for deriving Respiration Rate), resistance variation of Thermistor attached to the body (used for deriving Skin Temperature) and accelerometer data (input for deriving Respiration Rate and Posture). The Biosensor does not contain any natural rubber latex.
3.2 Relay Application
The Relay Application (App) can be downloaded onto a compatible mobile phone or tablet and manages the wireless communication between the Biosensor and the LifeSignals Secure Server.
The Relay App performs the following functions: Manages secured wireless communication (WLAN 802.11b) between Relay device and LifeSignals Biosensor and encrypted communication between the Relay device and the LifeSignals Remote Secure Server. Receives physiological signals from the Biosensor and transmit them after encryption to Secure Server as quickly as possible. It manages the database in Relay device for buffering/storing the data securely, if there is any disruption in communication with the Secure Server. Provides user interface for entering the Biosensor and Patient information and pairing and establishing connection with the Biosensor. Provides User Interface to record any manual alert events by the patient.
3.3 LifeSignals Secure Server
Secure Server is a LifeSignals Secure Server Application software installed in a compatible Linux based hardware platform of LifeSignals Inc. or any 3rd Party.
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LifeSignals Secure Server Application manages the decryption, uploading and storage of Biosensor data received from multiple authenticated Relay devices. The "Sensor Processing Library" installed in Secure Server then processes, filters the received physiological signals and derives Heart Rate, Respiration Rate, Skin Temperature and Posture before storing them in a secure location along with the received Biosensor data. These derived parameters and data received from various Biosensors shall be accessed by LifeSignals Remote Monitoring Dashboard or any 3rd party software for the purpose of display or analysis.
LifeSignals Secure Server Application shall have the optional ability to send alert notifications to any configured destination (email, SMS, WhatsApp), when the parameters (Heart Rate, Respiration Rate or Skin temperature) of a specific Biosensor (patient) exceed the configured limits.
3.4 Remote Monitoring Dashboard / Web UI
LifeSignals Web UI / Remote Monitoring dashboard is a web-browser User Interface Application that enables the Care Provider (Clinical personnel) to login to the Secure Server remotely and access the patient physiological data (Biosensor and derived data), and Alert Status. The Care Provider (Clinical personnel) depending on their roles (normal or supervisory) can access multiple patient data and search them based on the recent alert status. This includes patients that are active (wearing a Biosensor), and procedures completed.
Remote Monitoring Dashboard / Web UI shall also have an ability to continuously display physiological parameters (Heart Rate, Respiration Rate, Skin Temperature, Posture) and waveforms (ECG and Respiration) of multiple patients (up to 16 patients on a single screen) or of a single patient, quasi-real time, remotely on the screen for monitoring by a Care Provider (Clinical personnel).
4. Warnings
DO NOT USE if the patient has a known allergic reaction to adhesives or electrode hydrogels. DO NOT use if the patient has inflamed, irritated or broken skin in the Biosensor placement area. The patient should remove the Biosensor, if skin irritation such as severe redness, itching or allergic
symptoms develop and seek medical attention, if an allergic reaction persists beyond 2 to 3 days. The patient should not wear the Biosensor for more than the prescribed hours. The patient should remove the Biosensor immediately if their skin feels uncomfortably warm or
experience a burning sensation. The Biosensor should not be used as an apnea monitor, and it has not been validated for use in the
pediatric population.
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5. Precautions
Advise patient to avoid sleeping on their stomach, as this may interfere with the Biosensor performance.
DO NOT use the Biosensor if the package has been opened, appears damaged or has expired. Advise patients to avoid use of the Biosensor near (less than 2 meters) any interfering wireless
devices such as certain gaming devices, wireless cameras, or microwave ovens. Advise patients to avoid use of the Biosensor near any RF emitting devices such as RFID,
electromagnetic anti-theft devices and metal detectors as this could affect communication between Biosensor, Relay device and Server resulting in interruption of monitoring. The Biosensor contains a battery. Dispose of the Biosensor in accordance with local laws, care facility laws or hospital laws for routine/non-hazardous electronic waste. If the Biosensor becomes soiled (e.g., coffee spill), advise patients to wipe clean with a damp cloth and pat dry. If the Biosensor becomes soiled with blood, and/or bodily fluids/matter, dispose in accordance with local laws, care facility laws or hospital laws for biohazardous waste. DO NOT allow the patient to wear or use the Biosensor during a magnetic resonance imaging (MRI) procedure or in a location where it will be exposed to strong electromagnetic forces. DO NOT reuse the Biosensor, it is for single use only. Advise patients to keep the Biosensor out of reach of children and pets. Advise patient to keep showers short with their back to the flow of water while showering. Gently pat dry with a towel and minimize activity until the Biosensor is fully dry. Do not use creams or soap near the Biosensor. The patient should not immerse the Biosensor in water. The Biosensor should remain within the operating distance of the Relay (mobile) device (< 5 meters) for uninterrupted monitoring. The Relay (mobile) device uses a mobile data network (3G/4G) for its function. Before international travel, it may be required to enable data roaming. To ensure continuous streaming of data, the Relay (mobile) device should be charged once every 12 hours or whenever there is a low battery indication. Setting the alert threshold limits to extreme value can render the alert system useless.
6. Cybersecurity Controls
To protect against unauthorized use and cybersecurity threat, enable all access control systems on Mobile device (Password protection and / or Biometric control).
Enable automatic application updates in Relay device for any automatic cybersecurity updates of Relay Application.
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7. For Optimal Results
Perform skin preparation according to the instructions. If required, remove excess hair. Advise patients to limit activity for one hour after the Biosensor has been applied to ensure good skin adherence. Advise patients to carry out normal daily routine but avoid activities that cause excessive sweating. Advise patients to avoid sleeping on their stomach, as this may interfere with the Biosensor performance. Choose a new skin placement area with each additional Biosensor to prevent skin trauma. Advise patients to remove jewelry, such as necklaces, during the monitoring session.
8. LED Status Indicators
The Biosensor light (LED) provides information related to the functional status of the Biosensor.
Light
Status
Slow flash Fast flash Slow flash Alternative flashing Fast flash Off
Biosensor is connected to Relay App. Biosensor is connecting to Relay App. Low Battery indication. Response to receiver's "Identify Biosensor" command. Biosensor "Turned OFF".
Table 1. LED status
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9. Configuring the Mobile Phone / Tablet as a Relay Device
Note: This section can be ignored if the Mobile Phone is already configured as Relay device by the IT
Administrator. You can only use a compatible mobile phone/tablet as a Relay device. Please visit
https://support.lifesignals.com/supportedplatforms for a detailed list.
a) Download and install LifeSignals Relay App on the mobile phone/tablet. b) Download the Authentication Key received from the Secure Server Administrator (step 17.3 i)
and place it in `Download' folder of the mobile phone/tablet (internal storage). Refer to steps in section 17.3 on authentication key generation. c) Select `OPEN' (Relay App).
d) Select `Allow'.
e) Select `Allow'.
f) The Introduction Screen is then displayed, select `Next'.
g) The Relay App automatically begins authenticating.
h) When complete, click `OK'.
10. Start Monitoring
10.1 Perform Skin Preparation a) If required, remove excess hair from upper left chest area. b) Clean the area with non-moisturizing soap and water. c) Rinse the area making sure you remove all soap residues. d) Dry the area vigorously.
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Note: Do not use wipes or isopropyl alcohol to clean the skin prior to applying the Biosensor. Alcohol dries the skin, increases the possibility of skin irritation and can reduce the electrical signal to the Biosensor.
10.2 Assign Biosensor to the Patient a) Open the LifeSignals Relay App on your device. b) Remove the Biosensor from the pouch. c) Select `Next'. d) Manually input the unique Patch ID. Or e) Scan the QR code/barcode. f) Select `Next'. g) Enter Patient Details (Patient ID, DOB, Doctor, Sex). Or h) Scan the barcode in the patient ID bracelet. Select `Next'. i) Select `I AGREE'.
Note: Check the expiry date and the outer package for any damage. If data is not entered in the mandatory fields (Patient ID, DOB, Doctor), an error message highlighting the fields with missing information will appear.
10.3 Connect Biosensor a) If requested, turn on Mobile Hotspot in your phone/tablet settings. b) Configure phone hotspot with these details - SSID (Biosensor ID). c) Enter Password `copernicus'.
d) Return to Relay App - Select `OK'.
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e) Press the Biosensor `ON' button once. (A red light will flash followed by a flashing green light).
f) The mobile phone/tablet will automatically connect to the Biosensor.
10.4 Apply Biosensor a) Gently peel off the protective backing film. b) Place the Biosensor on the upper left chest, below the collar bone and left of the sternum. c) Press the Biosensor firmly around the edges and center for 2 minutes.
d) Select `Next'.
Note: If the connection is not successful within 2 minutes of turning ON, the Biosensor will switch OFF automatically (auto-power OFF).
10.5 Confirm and Start Monitoring Session a) Scroll down to check quality of ECG and respiration waveforms. b) If acceptable, Select `Continue'. c) If unacceptable, Select `Replace'. d) Select `SWITCH OFF'. The user will be brought back to `Assign Biosensor to the patient'. e) Click `CONFIRM' to start monitoring the session. f) The Biosensor is connected and the remaining time for the monitoring session is displayed.
11. Report Symptoms during Monitoring
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a) Press the `Green' button on the Relay App once. Or b) Press the Biosensor `ON' button once. c) Select appropriate symptom(s). d) Select activity level. e) Select `Save'.
12. End of Monitoring
a) When session duration has been reached, the session completes automatically. b) Click `OK'.
c) If required, another Biosensor can be assigned to initiate another monitoring session. Follow the instructions of Clinical personnel on how to replace Biosensor and continue session.
13. Advice for Patients
Inform the patient to:
Limit activity for one hour after the Biosensor has been applied to ensure good skin adherence. Carry out normal daily routine but avoid activities that cause excessive sweating. Press the Biosensor ON button or the Relay App Green button ONCE to report a symptom. Keep showers short with their back to the flow of water while showering. If the Biosensor accidentally gets wet, gently pat dry with a towel and minimize activity until the biosensor is fully dry. If the Biosensor loosens or starts to peel away, press down the edges with their fingers. Avoid sleeping on their stomach, as this may interfere with the Biosensor performance. Occasional skin itchiness and redness are normal around the Biosensor placement area. Charge the Relay (mobile) device once every 12 hrs or whenever there is a low battery indication.
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There may be some restriction in using the Biosensor and Relay App whilst flying, for example during take-off and landing, so you might have to turn off your mobile phone/tablet.
14. Inform your Patient
The Flashing green light is normal. When the monitoring session is complete, the green light will stop flashing. To remove the Biosensor, gently peel off the four corners of the Biosensor, then slowly peel off the remainder of the Biosensor. The Biosensor contains a battery. Dispose of the Biosensor in accordance with local laws, care facility laws or hospital laws for routine / non-hazardous electronic waste.
15. Troubleshooting Alerts Relay App
ALERT
SOLUTION
a) Enter Patch ID
If you forget to enter the Patch ID and select Enter Patch ID, then select `Next'. `Next', this alert will be displayed.
b) Lead Off
If any of the Biosensor electrodes become loose and lose contact with the skin, this alert will be displayed.
Press all the electrodes firmly on the chest. Ensure alert disappears.
c) Patch connection lost! Try holding your phone closer to the Patch.
If the Patch is too far away from the mobile phone/tablet, this alert will be displayed.
Keep the mobile phone/tablet within 5 meters of the Patch at all times.
d) Transfer to Server failed. Please check network connectivity
If the mobile phone/tablet is not connected to the network, this alert will be displayed.
Check the cellular network connection on your mobile phone/tablet
Table 2. Troubleshooting Alerts Relay App
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16. Additional Features Relay App
INSTRUCTIONS
EXPLANATION
a) Select Menu icon.
User can view Additional information.
b) Select "Identify Patch".
Note: - The LED on the patch will blink five times, Identifies the Biosensor that is currently in to identify the Patch that is currently being use. monitored.
c) Select `Stop Session'.
Correct password will stop monitoring
Note: - Contact your technical support for password. session.
d) Select `Session Summary'. e) Select `Back' to return to `report symptom'
screen. f) Select `About Relay'. g) Select `OK' to return to `Home screen.
Provides current details about the monitoring session.
Extra details are shown about the Relay.
Table 3. Additional Features Relay App
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17. Appendix
17.1 Table 4. Technical Specifications
Physical (Biosensor)
Dimensions
105 mm x 94 mm x 12 mm
Weight
28 gm
Status LED Indicators
Amber, Red and Green
Patient Event Logging Button Yes
Water ingress protection
IP24
Specifications (Biosensor)
Battery type
Primary Lithium Manganese dioxide Li-MnO2
Battery Life
120 hours (under continuous transmission under normal wireless environment)
Wear Life Defib Protection Applied Part Classification
120 hours (5 days)
Yes Defibrillation-proof type CF applied part
Operations
Continuous
Usage (Platform)
Intended environment
Home, Clinical and Non-Clinical facilities
Intended Population
18 years or older
MRI safe
No
Single use / Disposable
Yes
ECG Performance and Specifications
ECG number of channels
Two
ECG sampling rate
244.14 and 976.56 samples per second
Frequency response
0.2 Hz to 40 Hz and 0.05 Hz to 150 Hz
Lead off detection
Yes
Common Mode rejection ratio > 90dB
Input Impedance
> 10 Meg ohms at 10Hz
ADC Resolution
18 bits
ECG Electrode
Hydrogel
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Heart rate range Heart rate accuracy (Stationary
and Ambulatory) Heart rate resolution Update period Heart rate method
Measurement Range
Measurement Accuracy
Resolution
Respiration rate algorithm
TTI injection signal frequency TTI Impedance variation range TTI Base Impedance Update period Maximum Latency EDR - ECG derived respiration
Measurement Range Measurement Accuracy (Lab) Resolution Sensor Type Measurement site Update Frequency
Accelerometer Sensor Sampling Frequency Dynamic Range Resolution Posture
Frequency Band (802.11b) Bandwidth Transmit Power
Modulation
Wireless Security Data Rate Wireless Range
Heart Rate 30 250 bpm
± 3 bpm or 10% whichever is greater
1 bpm every beat Modified Pan-Tompkins
Respiration Rate 5-60 breaths per minute 9-30 Breaths per Minute with a mean absolute error of less
than 3 Breaths per Minute, validated by clinical studies 6-60 Breaths per Minute with a mean absolute error of less
than 1 Breaths per Minute, validated by simulation studies 1 breath per minute TTI (Trans-thoracic Impedance), Accelerometer and EDR (ECG
Derived Respiration). 10 KHz 1 to 5 200 to 2500 4 sec 20 sec R-S amplitude
Skin Temperature 29°C to 43 °C ± 0.2°C 0.1°C Thermistor Skin (chest) 1 Hz
Accelerometer 3-Axis (digital) 25 Hz +/-2g 16 bits Lying, Upright, Inclined
Wireless and Security 2.400-2.4835 GHz 20MHz (WLAN) 0 dBm Complementary Code Keying (CCK) and Direct Sequence
Spread Spectrum (DSSS) WPA2-PSK / CCMP 1, 2, 5.5 and 11 Mbps 5 meters (typical)
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Environmental
+0 C to +45C (32F to 113F)
Operational temperature
Maximum applied part measured temperature may vary by
0.5 C
Operational relative humidity 10 % to 90 % (non-condensing)
Storage temperature (< 30 days)
+0C to +45C (32F to 113F)
Storage temperature (> 30 days)
+10C to +27C (41F to 80F)
Transportation temperature ( 5 days)
-5C to +50C (23F to 122F)
Storage relative humidity
10% to 90% (non-condensing)
Storage pressure
700 hPa to 1060 hPa
Shelf life
12 months
Note*: QoS verified for 10 meters range in bench setup.
17.2 Table 5. Relay Application Messages
Message
Unable to connect to server, Try again RelayID [relay_id] is authenticated successfully. Authentication failed. Try again with correct key Key Error, Authentication failed. Try again with correct
key Turning off the Patch... Failed to switch off the Patch
Copy Server key to the Download folder
Try when network connectivity is present
Reconfigure Patch with a different password?
"Insufficient space to store data (" + (int) reqMB + "MB required). Delete any unwanted files or photos."
Failed to switch off the Patch. Patch battery level is low "Patch password updated" Reconfigure the hotspot SSID
[value] password[value]
Failed to reconfigure the Patch
Ending session... Session completed! Session completed! Patch connection failure. Select OK to retry. Failed to reconfigure the Patch
Description
Server unavailable Authentication success Authentication failure
Failed to import Server key
Patch turning off Patch failed to switch off Server key missing from download
folder Internet/Server not available After Biosensor is configured, you can
change the password Insufficient Memory on the mobile
device On socket error on turn-off Battery level lower than 15% Patch password successfully reconfigured Unable to reconfigure Patch password Monitoring session ending Monitoring session completed On Finalize completed Socket error on set mode Socket error on reconfigure
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17.3 Table 6. Guidance and Manufacturer's Declaration Electromagnetic Emissions Biosensor is intended for use in the electromagnetic environment specified below.
Emissions test
RF emissions CISPR 11 / EN5501 RF emissions CISPR 11 /EN5501
Compliance Group 1
Class B
Electromagnetic environment guidance
Biosensor use RF energy only for its internal functions. RF emissions are very low and are not likely to cause any interference in nearby electronic equipment. Biosensor is suitable for use in all establishments, including domestic establishments and those directly connected to the public low-voltage power supply network which supplies buildings used for domestic purposes.
17.4 Table 7. Guidance and Manufacturer's Declaration Electromagnetic Immunity Biosensor is intended for use in the electromagnetic environment specified below.
Immunity test
Compliance Level test level
Electrostatic discharge (ESD) as per IEC 61000-4-2 Power frequency magnetic field as per IEC 61000-4-8
Radiated RF as per IEC 61000-4-3
± 8 kV contact ± 15 kV air
30 A/m
10 V/m 80 MHz - 2.7 GHz, 80% AM at 1 KHz
The Biosensor is also tested for immunity to proximity to wireless communication equipment as per Table 9 of IEC 60601-1-2 using the test methods specified in IEC 61000-4-3.
17.5 FCC Statement
This device complies with Part 15 of the FCC rules. Operation is subject to the following conditions: This device may not cause harmful interference. This device must accept any interference received including interference that may cause undesired operation of this device.
Any changes or modifications not expressly approved by the party responsible for Compliance could void the user's authority to operate the equipment. Biosensor radiator (Antenna) is at 8.6mm away from the body and hence, exempted from SAR measurement. Please affix Biosensor on body as instructed in this manual for maintaining the separation distance.
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17.6 Table 8. Symbols
Label
Identification Caution or Warning
Description
This symbol instructs the user to consult the instructions for warnings and safety precautions that could not be presented on the device.
Manufacturer
Legal manufacturer
Product shall be separated when disposed of
Dispose of the Biosensor as battery waste - controlled by local regulations.
GUDID (Level 0) and On PCBA Level 0 GUDID in data matrix format
Serial No.
and Serial number in human readable format.
GUDID (Level 0) and Pairing ID
GUDID (Level 1,2 and 3)
Unique Pairing ID
On Patch Level 0 GUDID in data matrix format and Pairing ID in human readable format.
Device GUDID (Level 1, 2 and 3) with manufacturing information. Level 1: Serial No., Level 2 and 3: Lot No.
Unique Pairing ID
Catalog Number
Device Catalog number / Labeler Product number.
Quantity
Number of devices in pouch or multi-carton box.
Prescription only device
Consult instructions for use
Temperature range
To be used under prescription supervision by a medical practitioner.
Refer to instruction manual.
Operating, storage and transportation temperature, short and long term, in days: P: Duration, n: Number, D: Calendar days
Atmospheric pressure To indicate the acceptable upper and lower limits of
limitation
atmospheric pressure for transport and storage.
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Humidity limitation
To indicate the acceptable upper and lower limits of relative humidity for transport and storage.
Expiry Date (YYYY-MM-DD)
Manufacturing date and country of manufacture
LOT Code
Use device in packaged condition before expiry date.
Device manufacturing date and country of manufacture Manufacturing Batch or LOT code
Applied part
Defibrillation-proof, Type CF Applied Part
Do not reuse
Do not reuse; single patient use
Ingress Protection Rating
Protection against solid objects that are over 12.5 mm (e.g., large tools and hands) and protection against water splashing from any angle.
Keep dry
Keep away from liquids or water or chemicals.
FCC ID
Max Stack
Do not stack more than (n) number of boxes tall.
Federal Communications Commission
MR unsafe (black or red circle)
Federal Communications Commission ID
Standard practice for marking medical devices and other items for safety in the magnetic resonance environment.
No pacemaker
Contraindicated for use on patients with active implantable medical devices including pacemakers, ICD and LVAD.
Authorized Representative of European Community Authorized representative of Country
Authorized representative of European Community.
Authorized representative of Country XX Country code as per ISO 3166-1.
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CE marking
CE marking indicates product conformance with the applicable European Union Directives.
Ukraine Symbol of conformity to Technical Regulations
Importer
Indicates product conformance with applicable Ukrainian Technical Regulations UA.TR.116 Identifier code of the Conformity assessment body.
Indicates entity importing the medical device into the locale.
Distributor
Entity distributing the medical device into the locale.
Damaged packaging
Do not use if package is damaged. Device must not be used if the package holding the device is damaged.
17.7 Contact Information
Manufacturer: LifeSignals, Inc. 426 S Hillview Drive Milpitas, California 95035, USA Customer service (USA): +1 510.770.6412 www.lifesignals.com email: info@lifesignals.com
Biosensor is assembled in Republic of Korea
European Representative: Renew Health Ltd, IDA Business & Technology Park, Garrycastle Dublin Rd, Athlone, N37 F786, Ireland email: info@lifesignals.com
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