Otsuka America Pharmaceutical 06550 Proteus Wearable Sensor Module, Model SPC-0655 User Manual 1

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Document ID	2102274
Application ID	9zYOs03sw/opCRqJE7iIQw==
Document Description	Users Manual 1
Short Term Confidential	No
Permanent Confidential	No
Supercede	No
Document Type	User Manual
Display Format	Adobe Acrobat PDF - pdf
Filesize	15.84kB (197945 bits)
Date Submitted	2013-10-25 00:00:00
Date Available	2013-10-25 00:00:00
Creation Date	2013-09-19 16:41:10
Producing Software	Adobe PDF Library 10.0.1
Document Lastmod	2013-09-19 16:41:11
Document Title	Users Manual 1
Document Creator	Adobe InDesign CS6 (Macintosh)

CAUTIONS
ELECTROMAGNETIC & OTHER INTERFERENCES
THE PATCH
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.
The Patch has been tested and deemed in conformance
with the relevant requirements of EN60601-1-2:2007
Class B for Electromagnetic Compatibility (EMC).
PATCH BUTTON
INDICATOR LIGHT
Press and hold the
patch button for 3
seconds to initiate
communication
to Mobile Computing
Device.
A blinking green
light indicates that
communication to the
Mobile Computing Device
has begun.
EQUIPMENT SYMBOLS
LOT Batch code
SN
Serial number
REF Catalogue number
EC REP
Manufacturer
Read instructions before use
EC REP
Single use only
Temperature range				
PATCH POD
REPLACEABLE ADHESIVE STRIP
Contains electronics.
Contains skin electrodes.
Must be used with
Patch pod.
Humidity range				
Atmospheric Pressure range				
Do not dispose with household waste
Battery___________________________________________________________ Coin cell
Data recording time	�������������������������������������������� 30 days
Storage conditions ___________________________ Original package under
normal room temperature
and humidity
Water Resistant	�������������������������������������������������� 1 Meter
INSTRUCTIONS FOR USE
Emits radio waves
Use by yyyy-mm
SPECIFICATIONS
Proteus Digital Health
2600 Bridge Pkwy, Suite 101
Redwood City, CA 94065
Ph: +1-650-632-4031
European Authorized Representative
IP27 Ingress Protection rating of IP27
General warning
Remember: Use mobile device to
start Patch pod change
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
Proteus Patch — Extended Use
CAUTION: Federal (USA) law
restricts this device to sale by or on
the order of a physician.
COMPATIBLE WITH:
Replaceable Adhesive Strip (SPC-0656)
The Proteus Patch is a body-worn
sensor that collects physiological
and behavioral metrics (heart rate,
activity, body angle, and timestamped patient logged events).
REPLACING A PATCH POD monthly
REPLACING A STRIP weekly
1. REMOVE
1. REMOVE
3. PLACE
PATCH MAINTENANCE
Gently press in the middle of the
strip to release the used Patch
pod. Do not discard your used
Patch pod yet.
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.
Gently pat your skin at the
selected location with the
provided alcohol wipe. Wait for
your skin to dry.
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.
2. CONNECT
2. CHOOSE
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.
Select a location on the left side of your body just
above the lower edge of your rib cage (see shaded
areas to right).
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.
Press the Patch pod into the
frame of the strip until you
hear it click. DI
Avoid locations
●●
Where undergarments may
press against the Patch
●●
Where your previous Patch
was just removed
4. DISPOSE
To facilitate later Patch removal,
use clippers to trim any hair from
your selected location.
3. ATTACH
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).
Peel off the first backing from a
strip. Take care not to wrinkle the
adhesive.
ADDITIONAL INFORMATION
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.
For further instruction on troubleshooting and
technical information, please visit:
www.proteus.com/suppinfo/
ProteusPatch_ExtendedUse.pdf

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