CONFIDENTIAL
10/29/20 1:52:12 PM – IFU
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©2020 ETROG SYSTEMS LTD.
5
Precautions:
•
For data to be sent to a healthcare professional for review: The device battery must have
adequate power for data transmission. Red flashing LED on device will indicate that the battery
power is low. Low power device notification will be passed to gateway and server too.
•
The patch must be attached to the patient. Notification will indicate if the patch is off
the body or not properly attached.
•
The patient must remain in range of their gateway (i.e. smartphone, PC, tablet, body
worn cellular modem or wall mount device). Notification will indicate that the sensor
has disconnected from the gateway.
•
The gateway must remain charged and functional for data transmission. Wireless
connectivity must be active for transmission of data from the gateway to the server.
•
Healthcare providers must be aware if uninterrupted continuous data monitoring is
necessary for patient safety, treatment in home setting may not be appropriate. If there
is a clinical need, additional measures may be taken to ensure appropriate care.
•
Data collected by MULTIVS ES008A for patients experiencing cardiac arrhythmia may
indicate slightly elevated respiratory rate values, compared to visual observation, for the
duration of the active arrhythmic episode.
•
The gateway device must operate and connected ONLY to MULTIVS ES008A during
active monitoring. please note that performance of either or both Bluetooth connected
devices/system could potentially be affected if gateway is used for other purpose.
•
Similar devices may cause signal interference during data transmission. If you
experience this affect, steer clear of interfering devices.
•
Do not use the device if the package has been opened, or appears used, damaged, or
expired.
•
Do not wear device over excessive body hair in the torso area. Excessive body hair
should be removed several hours before application.
•
Do not use the patch when showering or bathing.
•
if discomfort or irritation occurs to the patient, device should be removed.
•
If the patient experience mild soreness or redness after removing the patch, a new
patch should not be placed in the same location.
•
Incorrect handling, excessive force, or dropping the device may cause malfunction or
permanent damage.
•
The device must be kept away from children and pets. The device may be a choking
hazard, and may be harmful if swallowed.
•
If any component of the MULTIVS ES008A ETROG
®
Care Platform fails to operate after
attempting all suggested troubleshooting methods, the patient should contact his
healthcare provider as soon as possible..
•
Clinical validation performed in mixed age population, including elderly subjects (Age 59
to 86) with a BMI (Body Mass Index) range of 13.5-59.5 kg/m2.
•
Dispose of MULTIVS ES008A per local laws, care facility laws or hospital laws for
routine/non- hazardous electronic waste.
