VitalConnect Platform - Data Accuracy; Error Codes; Description; Service Provider

IFU-01, Rev. A Page 7 of 20
Recommendations:
 For a good connection and proper operation, the VitalConnect Sensor should NOT be
worm over areas with a high concentration of body hair in the torso area. Removal of
body hair on the torso area is recommended before placing the VitalConnect Sensor.
 Recommend gently wiping the sensor module with a damp cloth, after every use
 Recommended operating temperature range: 10 - 43 deg C
 Recommended shipping and storage temperature range: 0 – 50 deg C
 Recommended shipping and storage relative humidity range: 10 – 95% RH
 Recommended operating relative humidity range: 10 – 95% RH
 Recommended operating altitude: < 2000 m
 Recommended barometric pressure: 80 kPa
Data Accuracy:
Data accuracy for the following attributes is measured through various bench testing test cases
in compliance with ANSI/AAMI/IEC 60601-2-47: 2012. They include:
 clause 201.12.4.4.101, Linearity and Dynamic Range,
 clause 201.12.4.4.102, Input Impedance
 clause 201.12.4.4.103, Common Mode Rejection
 clause 201.12.4.4.104, Gain Accuracy
 clause 201.12.4.4.105, Gain Stability
 clause 201.12.4.4.106, System Noise
 clause 201.12.4.4.108, Frequency Response
 clause 201.12.4.4.110, Timing Accuracy
 clause 201.12.1.101.3.1, Heart Rate
 clause 201.12.1.101.3.7, ECG Hard Copy
Error Codes/ Description:
VitalConnect Platform is capable of generating the following user error message:
 Communication not established
 Communication lost
 Battery low
 Bad battery
Service Provider: