User's Manual

Page 6 of 72
1000001386A
● There may be some restriction in using Biosensor & Relay Application in Airport
due to FAA regulation of wireless network operation during a certain period (take-
off or landing) and TSA regulation of screening Mobile device (Relay device).
Further, Relay device is required to be connected to the Internet continuously for
transmission of data to Secure Server and some airlines do not offer wireless
internet connectivity feature on-board
5. Precautions:
● A new skin site should be used with each new Biosensor to prevent trauma to the
skin
● For proper skin management and to minimize skin irritation, skin sites must be
properly prepared prior to placement of the Biosensor. Use your facility’s electrode
application protocol to prepare the site. Alternatively:
o Ensure placement of the Biosensor only on clean and thoroughly dried skin
o Remove excess hair with hair clippers to avoid skin damage prior to
placement
o Use Nuprep
®
or equivalent commercially available ECG skin prep pad per
the instructions for use. Do not abrade the skin
o Avoid removing the Biosensor frequently and/or applying to the same skin
site
o When handling the Biosensor, avoid dropping the device on hard services,
or against sharp edges and corners. Do not apply weight or pressure or
apply excessive stress on the Biosensor
● Assess the Biosensor site periodically. In the event of skin irritation, itching or
discomfort, remove the Biosensor immediately and bring to the attention of clinical
care personnel
● Keep the Biosensor dry during use. The Biosensor is IP24 ingress protection rated.
Do not immerse the Biosensor in fluids or chemicals
● Recommended long term storage (more than 1 month) temperature is 5⁰C to 27⁰C
● Do not store the Biosensor package in direct sunlight
● Avoid sleeping in the chest down (prone) position as it will affect the wireless
performance
● Avoid wearing Jewellery (like chains) or any accessories that may come in physical
contact and potentially catch on, lift or dislodge the biosensor
● Avoid any direct pressure (Example: sleeping in prone position, take care while using
aids like safety harnesses, exercise and using exercise equipment etc.) on the
biosensor when worn on the body
● Carefully remove the Biosensor at the end of monitoring to avoid skin injury. Use
adhesive removal pads to loosen the adhesive
● Recycle the Biosensor in accordance with local, state and federal requirements as
Li-MnO2 battery waste
● Keep the Biosensor away from small children
● Biosensor should be within the operating distance of the Relay device (< 5 meters)
for uninterrupted monitoring
● Use recommended hardware platform as Relay device. Please visit
https://support.lifesignals.com/supportedplatforms for the details for the compatible
mobile phones