User's Manual

Page 5 of 72
1000001386A
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. Warnings:
● Do not use Biosensor on patients who are allergic to adhesive, electrode gel or
non-woven materials
● Do not reuse Biosensor. It is a single-use device
● Biosensor is rated for ingress protection rating of IP24. It is not designed for being
submerged in water. Hence, avoid swimming while wearing a Biosensor
Note: Avoid taking direct shower while wearing a Biosensor
● Do not wear Biosensor beyond the recommended maximum wear duration of 120
hours
● Do not use the Biosensor on damaged (irritated or injured) or breached skin
● Do not use the Biosensor beyond the expiration date
● Do not use the Biosensor if the package or the device is damaged, leaking or
tampered with
● Do not use the Biosensor if the gel in any of the electrodes is dry, discolored or no
longer sticky
● The Biosensor does not have any serviceable parts. Do not try to modify or repair
the Biosensor. Any modification may result in patient harm
● Avoid use of the Biosensor near (< 2 meter) other 2.4GHz continuous emission
devices such as certain gaming devices, wireless cameras, older cordless phones,
or a microwave oven
● Portable RF communications equipment (including peripherals such as antenna
cables and external antennas) should be used no closer than 30 cm (12 inches) to
any part of the Biosensor. Otherwise, degradation of the performance of this
equipment could result