User's Manual

Page 2 of 72
1000001386A
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. Pairing the Biosensor with Relay Application & starting the procedure 22
9.5. Other Alerts and features 36
9.6. End of Monitoring 40
9.7. Removing the Biosensor 42
10. Instructions (For Secure Server Administrator): 43
10.1. Adding / Configuring a new Relay device to the Platform through Web Application 43
10.2. Adding New User 45
10.3. Deleting Existing User 46
10.4. Changing the Password 47
10.5. Recent Alerts 48
10.6. Technical Alerts 50
10.7. All Active Patients 51
10.8. Unused Patches 58
10.9. Completed 59
11. Appendix 62
11.1. Table 1: Biosensor (LP1550) Specifications 62
11.2. Table 2: Platform (LX1550) Heart Rate, RR, Skin temperature and Accelerometer
Specifications 63
11.3. Table 3: Relay Application Error Messages 65
11.4. Table 4: Web UI Error Messages 66
11.5. Table 5: Guidance and Manufacturer’s Declaration – Electromagnetic emissions 68
11.6. Table 6: Guidance and Manufacturer’s Declaration – Electromagnetic Immunity 69
11.7. Table 7: FCC Statement 69