Proteus Digital Health 06550 Proteus Wearable Sensor Module, Model SPC-0655 User Manual 1

Proteus Digital Health, Inc. Proteus Wearable Sensor Module, Model SPC-0655 Users Manual 1

Contents

Users Manual 1

SPECIFICATIONS
Battery __________________________________________________________ Coin cell
Data recording time ____________________________________________ 30 days
Storage conditions __________________________Original package under
normal room temperature
and humidity
Water Resistant __________________________________________________ 1 Meter
CAUTIONS
DO NOT continue use until further instructed by
a physician if your skin is irritated or inflamed around
the replaceable adhesive strip.
DO NOT place in locations where your skin is scraped,
cracked, inflamed, or irritated.
DO NOT place in a location that overlaps the area of
the most recently removed replaceable adhesive strip.
DO NOT use if you are allergic to adhesive tape.
DO NOT wear the same replaceable adhesive strip for
longer than one week.
DO NOT drop or bump with excessive force.
DO NOT use to diagnose heart-related conditions.
DO NOT wear during airplane travel.
DO NOT wear during magnetic resonance imaging (MRI),
cautery, and external defibrillation procedures.
DO check the expiration date before applying.
DO NOT store in extremely hot, cold, or
humid conditions.
CAUTION: Patch pod is a choking hazard.
ELECTROMAGNETIC & OTHER INTERFERENCES
The Patch has been tested and deemed in conformance
with the relevant requirements of EN60601-1-2:2007
Class B for Electromagnetic Compatibility (EMC).
EQUIPMENT SYMBOLS
Batch code
Serial number
Catalogue number
European Authorized Representative
Manufacturer
Read instructions before use
Emits radio waves
Single use only
Temperature range
Humidity range
Atmospheric Pressure range
Use by yyyy-mm
Do not dispose with household waste
Ingress Protection rating of IP27
General warning
INSTRUCTIONS FOR USE
Proteus Patch — Extended Use
THE PATCH
PATCH BUTTON
Press and hold the
patch button for 3
seconds to initiate
communication
to Mobile Computing
Device.
Contains electronics. Contains skin electrodes.
Must be used with
Patch pod.
INDICATOR LIGHT
A blinking green
light indicates that
communication to the
Mobile Computing Device
has begun.
Remember: Use mobile device to
start Patch pod change
LOT
SN
REF
CAUTION: Federal (USA) law
restricts this device to sale by or on
the order of a physician.
Proteus Digital Health
2600 Bridge Pkwy, Suite 101
Redwood City, CA 94065
Ph: +1-650-632-4031
Proteus Digital Health UK Ltd.
6th Floor, 41 - 44 Great Queen St.
London WC2B 5AD
0086
US Patent No. 8114021
Made in USA
LBL-0140, Rev 2 | 19SEP2013
IP27
EC REP
EC REP
PATCH POD REPLACEABLE ADHESIVE STRIP
!COMPATIBLE WITH:
Replaceable Adhesive Strip (SPC-0656)
PATCH MAINTENANCE
High levels of activity and water exposure
(e.g. showering, bathing, or swimming) may cause
the Patch to peel off. To help the Patch remain
attached, wait at least one hour after applying the
Patch before exercising or exposing it to water.
When you do exercise or get the Patch wet, you
should pat the Patch dry and gently run your
fingers along the adhesive to prevent peeling.
ADDITIONAL INFORMATION
For further instruction on troubleshooting and
technical information, please visit:
www.proteus.com/suppinfo/
ProteusPatch_ExtendedUse.pdf
The Proteus Patch is a body-worn
sensor that collects physiological
and behavioral metrics (heart rate,
activity, body angle, and time-
stamped patient logged events).
Installation involves connecting the
Patch pod to a Mobile Computing
Device and affixing it to your skin
using a replaceable adhesive strip
(strip). The Patch may be worn
during most activities, including
exercising and bathing.
REPLACING A STRIP weekly
1. REMOVE
Gently press in the middle of the
strip to release the Patch pod. Set
it aside for the final step. Pull the
used strip away from your skin and
discard.
2. CHOOSE
Select a location on the left side of your body just
above the lower edge of your rib cage (see shaded
areas to right).
Avoid locations
Where undergarments may
press against the Patch
Where your previous Patch
was just removed
To facilitate later Patch removal,
use clippers to trim any hair from
your selected location.
REPLACING A PATCH POD monthly
1. REMOVE
Gently press in the middle of the
strip to release the used Patch
pod. Do not discard your used
Patch pod yet.
2. CONNECT
Turn on the Mobile Computing Device and launch
application. Open the Patch screen and tap “New
Pod.” Follow instructions on your Mobile Computing
Device to connect a new Patch pod.
3. ATTACH
Press the Patch pod into the
frame of the strip until you
hear it click. DI
4. DISPOSE
Check status of the used Patch pod. When the data
transfer is complete, dispose of the used Patch pod
as you would any household battery or electronics
(please check your local electronic waste
disposal standards).
3. PLACE
Gently pat your skin at the
selected location with the
provided alcohol wipe. Wait for
your skin to dry.
Peel off the first backing from a
strip. Take care not to wrinkle the
adhesive.
Stand in a comfortable, upright
position. Orient the strip
horizontally and apply to your
selected location. Remove the
second backing, and smooth the
strip with your fingers.
4. ATTACH
Press your Patch pod into the
frame on the strip until you
hear it click.

Navigation menu