Otsuka America Pharmaceutical 01750 Electronics module for body worn personal monitors User Manual

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Document ID	1968905
Application ID	FJUTXG6l2kVIfmcgRMUzkw==
Document Description	Users Manual
Short Term Confidential	No
Permanent Confidential	No
Supercede	No
Document Type	User Manual
Display Format	Adobe Acrobat PDF - pdf
Filesize	25.1kB (313700 bits)
Date Submitted	2013-05-20 00:00:00
Date Available	2013-05-21 00:00:00
Creation Date	2013-05-17 10:20:17
Producing Software	Adobe PDF Library 10.0.1
Document Lastmod	2013-05-17 17:19:05
Document Title	Users Manual
Document Creator	Adobe InDesign CS6 (Macintosh)

CAUTIONS
ELECTROMAGNETIC & OTHER INTERFERENCES
THE PATCH
DO NOT continue use until further instruction by
a physician if your skin is irritated or inflamed around
the Patch.
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 Patch.
DO NOT use if you are allergic to adhesive tape.
DO NOT wear the same Patch 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.
The Patch has been tested and deemed in conformance
with the relevant requirements in 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
European Authorized Representative
Manufacturer
Read instructions before use
Proteus Patch
Emits radio waves
Single use only
Temperature range				
Humidity range				
SPECIFICATIONS
Battery
Data recording time
Storage conditions
Water Resistant
Atmospheric Pressure range				
Coin cell
5 - 7 days
Original package under
normal room temperature
and humidity
1 Meter
INSTRUCTIONS FOR USE
Type BF applied part
Use by yyyy-mm
Manufacturer
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
Do not dispose with household waste
IP27 Ingress Protection rating of IP27
Remember: Use mobile device to
start patch change
US Patent No. 8114021
Made in USA
LBL0093, Rev 2 17MAY2013
CAUTION: Investigational device.
Limited by United States law to
investigational use.
The Proteus Patch is a bodyworn sensor that collects
physiological and behavioral
metrics (heart rate, activity, body
angle, and time-stamped patientlogged events). Installation
involves connecting the Patch
to a Mobile Computing Device
and affixing the Patch to your
skin. The Patch may be worn
during most activities, including
exercising and bathing.
REPLACING A PATCH
2. CONNECT
To Start...
After the data is cleared from your used Patch, your
Mobile Computing Device will instruct you to connect a
new Patch.
Turn on the Mobile Computing Device and lauch
application. Open the Patch screen and tap “New Patch.”
1. CLEAR
2. Prepare your skin by gently patting
the location you have selected with
the provided alcohol wipe.
Wait for your skin to dry.
NEW
Before putting on a new Patch, follow the instructions
on your Mobile Computing Device for clearing your
used Patch.
3. PLACE
When you are connected:
USED
To Remove a Used Patch...
Gently pull the Patch away from your skin.
Dispose of the Patch as you would any household
batteries or electronics (please check your local electronic
waste disposal standards).
3. Apply the Patch
a. Remove a Patch from its pouch and
peel off the first backing. Take care
not to wrinkle the adhesive.
b. Stand in a comfortable, upright
position. With the Patch button facing
upwards, apply the Patch to your
selected area.
1. Select a location on the left side of your body just
above the lower edge of your rib cage (see shaded areas
in figure).
Avoid locations:
l On your abdomen below your rib cage.
l Where undergarments may press against the Patch.
l Where your previous Patch was just removed.
To facilitate later Patch removal, use clippers to trim any
hair from your selected location.
c. Make sure to peel off the second
backing. Then smooth the edges
around the Patch with your fingers.
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.proteusdigitalhealth.com/suppinfo/
RP4_patch.pdf

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