LifeSignals Multi Parameter Remote Monitoring Platform Technical User Manual Revision History: Revision Rev A Rev B Rev C Rev D Rev E Rev F Date See IMSXpress See IMSXpress See IMSXpress See IMSXpress See IMSXpress See IMSXpress Description of change Approved by Initial draft release See IMSXpress Refer to Redline Document Refer to Redline Document Refer to Redline Document Refer to Redline Document Refer to Redline Document Page 1 of 72 1000001386A See IMSXpress See IMSXpress See IMSXPress See IMS
Table of Contents 1 Intended Use: 4 2 Contraindication: 4 3 Product Description and Workflow: 4 4. Warnings: 5 5. Precautions: 6 6. Cybersecurity controls: 7 7. Additional Information: 7 8. Indicators & Error Messages: 7 9. Instructions (For Clinical Personnel): 8 Configuring the Mobile as a Relay Device 8 9.1. Patient Body preparation 19 9.2. Biosensor Affixing 20 9.3. Switching ON the Biosensor & Connecting to Mobile device 21 9.4.
11.8.
1 Intended Use: • The LifeSignals Multi-Parameter Remote Monitoring Platform is a wireless remote monitoring system intended for use by healthcare professionals for continuous collection physiological data in home and healthcare settings. This can include Electrocardiography, Heart Rate, Respiration Rate, skin temperature & body posture in home and healthcare settings. Data is transmitted wirelessly from LifeSignals Biosensor to Remote secure server for display, storage and analysis.
Remote Monitoring Workflow The Multi Parameter Remote Monitoring platform will be able to measure parameters such as 2 channel ECG, Heart Rate, Respiration Rate & skin Temperature. It shall also include accelerometer to detect activities, in addition to providing input to the Respiration algorithm. Respiration algorithm is based on TTI (Trans-thoracic Impedance), EDR (ECG Derived Respiration) and accelerometer data. 4.
● 5. ● ● ● ● ● ● ● ● ● ● ● ● ● ● There may be some restriction in using Biosensor & Relay Application in Airport due to FAA regulation of wireless network operation during a certain period (takeoff or landing) and TSA regulation of screening Mobile device (Relay device).
● ● ● 6. ● ● ● 7. ● 8. Use only the recommended OS version (Android version) for compatibility of Relay Application Please visit https://support.lifesignals.com/supportedplatforms for the details for the compatible operating system Relay (Mobile) device uses mobile data network for its function. Hence, necessary precaution (e.g. enabling data while roaming) may be required before international travel Relay (mobile) device battery requires necessary charge for this function.
9. Instructions (For Clinical Personnel): Configuring the Mobile as a Relay Device o Use only the compatible mobile phone as a Relay device. Please visit https://support.lifesignals.
o If for some reason, the Relay Application is not Authenticated, then you will see the below screen o If there is no connectivity, then the below screen is seen Page 9 of 72 1000001386A
• o Go to Device settings and check for Internet connectivity and ensure that the device is connected to the internet. Once the device is connected, follow the next steps When the Relay Application gets authenticated automatically by connecting to the secure server, you will see the biosensor QR Code scanning page.
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o To know about the Relay, click the Menu (three dots on the top right) (Step 1) o Select About Relay (Step 2) Page 12 of 72 1000001386A
o Details about the device is shown Page 13 of 72 1000001386A
o The Discovery page can add new biosensors in two ways, with QR code scanning (Option 1) or manual entry (Option 2).
o If QR Code scanning is chosen, then the scanner looks for a QR code to scan o If Relay is added through manual entry, then the information must be typed in the Patch ID section Page 15 of 72 1000001386A
o If information is not typed and Next button is clicked, error is displayed Page 16 of 72 1000001386A
o For manual entry, once the information is provided and the Next button clicked, the screen requesting more information comes up.
o Once all the information is input, the Patient Consent notice pops-up Page 18 of 72 1000001386A
o On choosing the I AGREE option, the initial setup is complete. 9.1.
Prep site (Male) 9.2. Nuprep® & Gauze Pad Prep site (Female) Biosensor Affixing o Carefully remove Biosensor from the Aluminum Pouch ▪ Please check for expiry date information & any damage to the packaging o Remove the release liner in the Biosensor o Hold the Biosensor with the antenna at the top and letters on the label upright o Align the Biosensor with top right corner (RU electrode), close to the junction of sternum & collar bone.
9.3. Switching ON the Biosensor & Connecting to Mobile device o Press ON button to switch on the Biosensor o Momentarily the red LED will turn ON o Green LED will blink at a faster rate (~ 2 blinks per second) indicating that the Biosensor is trying to establish a connection with the Mobile device Hotspot o If the connection is successful, then the green LED blinking rate will be reduced.
9.4. Pairing the Biosensor with Relay Application & starting the procedure o Open the Relay Application in Mobile device. Application will automatically connect to the Secure Server & details will be displayed.
o Once the App is connected to the biosensor, the plotting screens for the 2 channels of ECG and respiration wave form along with other numerical parameters such as HR, RR, TEMP and Posture will be displayed Page 23 of 72 1000001386A
o Scroll down to view plot from the other ECG channel Page 24 of 72 1000001386A
o Continue to scroll down to view the respiration rate waveform Page 25 of 72 1000001386A
o By clicking the Menu (top three dots on the right), several options are available Page 26 of 72 1000001386A
o If for some reason, you want to remove or replace the patch, you can click the Replace button Page 27 of 72 1000001386A
o By selecting the CANCEL button, it goes back to the previous screen Page 28 of 72 1000001386A
o If SWITCH OFF option is selected, then the screen goes back to the initial setting where Patch ID can be entered by scanning with QR Code or manual entry Page 29 of 72 1000001386A
o Once all the relevant information is input and verified, there is an option to CANCEL OR CONFIRM Page 30 of 72 1000001386A
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o Once the CONFIRM button is clicked, the patch is connected and the remaining time for monitoring is displayed o If at any time, the details of the session are needed, the Menu (3 dots on the top) can be chosen and Session Summary selected Page 34 of 72 1000001386A
o The Session Summary is then displayed Page 35 of 72 1000001386A
o 9.5.
o When connection between Relay Device and Server is broken, below alert is displayed Page 37 of 72 1000001386A
o When any leads of the biosensor are lifted from the body, then the Lead Off alert is displayed Page 38 of 72 1000001386A
o Add Event feature: At any time during the procedure, if the Patient feels the need to record an event, he or she can do so by appropriately pressing the ON button on the biosensor or the Green button in the Relay Application (above screen) and Add Event page comes up on the Relay Device.
9.6.
o Once Finalization is complete, the Relay Application will try to switch off the Biosensor and erase all the data present in the biosensor and on the Relay Device.
o 9.7. If required, another Biosensor can be paired to initiate another monitoring procedure Removing the Biosensor o Gently pull the bottom right corner of the Biosensor and remove it from the body o To aid the removal of Biosensor, it may be helpful to use an over-the-counter medical adhesive remover.
10. 10.1.
● Then select the “Add Relay” (Step 1) ● Select the ID of the Relay device for which Alert Thresholds need to be updated (Step 2) ● Fill in all the appropriate parameters ● Select maximum operating time of the Biosensor (120 hours).
● Then press ‘Create’ button. ● Relay device authentication key (file name: ‘xxxxx. key’) will get generated & will be downloaded in local drive. ● Forward this key to the clinical personnel who would be configuring his/her Mobile device as a Relay device 10.2.
● Select the desired “Role” and fill in all the appropriate information ● Click on ‘ADD USER’ button. User will then be added. ● The default password is Life@2020 10.3.
● Click on the ‘Manage Users’ in the menu ● Search for the User Name that needs to be deleted o 10.4.
● Click on the Profile in the menu (Step 1) ● From the drop-down menu, click on ‘Change Password’ button. (Step 2) ● The default password as stated in Section 10.
• From the Menu, click on Recent Alerts • A list of all the recent alerts are displayed • A list of all the recent alerts are displayed Page 49 of 72 1000001386A
10.6.
10.7.
• List of All Active Patients will be displayed • • Select the info you want to further review in detail (Step 1) Click the Add to Dashboard button (Step 2) Page 52 of 72 1000001386A
• The selected info will be displayed as shown below • • Click on the info you want to see in more detail You will see the ECG waveform from one channel as shown below Page 53 of 72 1000001386A
• To see the ECG from the other channel, click on the Heart Rate display as shown below • You will now see the ECG from the other channel as shown below Page 54 of 72 1000001386A
• Click on the Respiration Rate information and the graph for Respiration rate is shown as below Page 55 of 72 1000001386A
• Click on Alert settings • • You can review and edit the Alert Thresholds as required Once done, click on the Save button Page 56 of 72 1000001386A
• • Another way of directly updating the Alert Settings from the All Active Patients menu is to select the Patient (Step 1) Click on the Alert Settings button (Step 2) Page 57 of 72 1000001386A
• 10.8.
• 10.9.
• List of all completed patches are displayed Page 60 of 72 1000001386A
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11. 11.1. Appendix Table 1: Biosensor (LP1550) Specifications Specifications ECG channels Two (2) ECG-A and ECG-D Classification of Applied parts Defibrillation proof type CF** Frequency Response 0.2 Hz to 40 Hz CMRR > 90dB Input impedance > 10 Meg ohms at 10Hz ADC sampling rate 244.
Operational relative humidity 10 % to 90 % (noncondensing) Storage temperature (≤ 30 days) +0⁰C to +45⁰C (32⁰F to 113⁰F) Storage temperature (> 30 days) +5⁰C to +27⁰C (41⁰F to 80.6⁰F) Storage relative humidity 30 % to 75 % (noncondensing) Storage pressure 700 hPa to 1060 hPa Ingress protection IP44 Physical Characteristics Dimensions 115 mm x 110 mm Weight < 30 gm Color White or off white Wear life 120 hours Wireless Specifications 2.400-2.
Measurement Range 30 BPM to 250 BPM Measurement algorithm Four consecutive R-R intervals averaging Accuracy ± 3 BPM or 10% whichever is higher Heart Rate Alert setting - High 100 to 250 BPM (Default: 120 BPM) -Low 30 to 100 BPM (Default: 40 BPM) Measurement Range 5 to 60 BrPM Measurement algorithm Respiration algorithm based on both TTI (Trans-thoracic Impedance) and EDR (ECG Derived Respiration).
Sampling rate 25 SPS Dynamic range ± 2g 11.3. Table 3: Relay Application Error Messages Message Description Backend exe Failed Server broke for some reason Authenticated Authentication success Authentication Failed Authentication failure Duration is not present.
Do you want to re-configure sensor to a different SSID? On patch selected, to change SSID A session with the sensor was found incomplete. Do you want to continue the current session? Restore session Device configuration updated successfully. Reconfigure patch success Unable to reconfigure patch. Reconfigure patch failure FINALIZING... Finalizing started The sensor has completed streaming. Please exit the application. On Server Response, patch Status = Completed Finalization completed.
Remove Patch Failed! Server was not able to execute remove patch command Patch removed! Server successfully executed remove patch command Please provide a valid HR High value Invalid HR High value. Please provide a value between 100 BPM to 250 BPM HR High value is not within the valid range. Please provide a valid HR Low value Invalid HR Low value. Please provide a value between 30 BPM to 100 BPM HR Low value is not within the valid range.
Username already taken! Please try another one. The entered username already exists. Password should be of 8 or more characters in length and should contain at least one numeric digit, one special character, one uppercase and one lowercase letters. The password must meet all the specified parameters Cannot add user Failed to create a new user. User added successfully! The user was successfully added to the database.
11.6. Table 6: Guidance and Manufacturer’s Declaration – Electromagnetic Immunity The Biosensor is tested for conformance to meet the following intended for use in the electromagnetic environment specified below. The customer or the user of the Biosensor should assure that it is used in such an environment.
11.8. Symbols Label Identification Stand-By This symbol indicates that the switch or switch position by means of which part of the equipment is switched on Caution or Warning 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 Recycle Disposal of the medical device to be controlled according to local regulations as battery waste GUDID (Level 0) & Serial No.
FCC ID Refer to Instruction Manual/booklet Refer to instruction manual/booklet Temperature range Storage (long term) within the specified temperature range Expiry Date (YYYY-MMDD) Use device in packaged condition before expiry date Manufacturing date Device manufacturing date LOT Code 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.
Damaged package Indication Do not use if package is damaged Contact Information Manufacturer: LifeSignals, Inc. 39355 California Street, Suite 305 Fremont, CA 94538. USA Customer service (USA): 1.510.770.64 http://www.lifeSignals.com email: info@LifeSignals.
