Otsuka America Pharmaceutical 06120 Proteus Patch, Model SPC-0800 User Manual1

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Document ID	2179623
Application ID	mW7HFgzbB13Edqh709jiFw==
Document Description	Users Manual1
Short Term Confidential	No
Permanent Confidential	No
Supercede	No
Document Type	User Manual
Display Format	Adobe Acrobat PDF - pdf
Filesize	41.39kB (517399 bits)
Date Submitted	2014-01-28 00:00:00
Date Available	2014-01-28 00:00:00
Creation Date	2013-12-17 07:57:08
Producing Software	Adobe PDF Library 10.0.1
Document Lastmod	2013-12-17 07:57:09
Document Title	Users Manual1
Document Creator	Adobe InDesign CC (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 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 NOT store in extremely hot, cold, or humid
conditions.
DO check the expiration date before applying.
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
REF Catalogue number
EC REP
European Authorized Representative
Read instructions before use
Type BF applied part
INSTRUCTIONS FOR USE
Emits radio waves
EC REP
Single use only
Water resistant
Do not dispose with household waste
Coin cell
5 – 7 days
Original package under
normal room temperature and
humidity
1 meter
Proteus Patch
Humidity range				
Use by yyyy-mm
Battery
Data recording time
Storage conditions
Proteus Digital Health UK Ltd.
6th Floor, 41 – 44 Great Queen St.
London WC2B 5AD
Temperature range				
Atmospheric Pressure range				
SPECIFICATIONS
Proteus Digital Health
2600 Bridge Pkwy, Suite 101
Redwood City, CA 94065
Ph: +1-650-632-4031
Manufacturer
0086
US Patent No. 8114021
Made in USA
LBL-0170, Rev 2 | 17DEC2013
IP27 Ingress Protection rating of IP27
Remember: Use Mobile Computing
Device to start patch change
CAUTION: Investigational device.
Limited by Federal (USA) 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
1. REMOVE
Pull the used Patch away from your
skin. Do not discard until your new
Patch is connected.
2. Prepare your skin by using clippers
to trim any hair from selected location.
Gently pat the location you have
selected with the provided alcohol
wipe. Wait for your skin to dry.
3. Apply the Patch
2. CONNECT
Turn on the Mobile Computing
Device and launch application. Follow
instructions in the application to
connect a new Patch.
3. PLACE
When you are connected:
1. Select a location on the left side of
your body just above the lower edge
of your rib cage (see indicated areas in
figures).
Avoid locations:
• Where undergarments may press
against the Patch.
• Where your previous Patch was
just removed.
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.
4. DISPOSE
PATCH MAINTENANCE
Finally, check status of the previously
removed used Patch on your Mobile
Computing Device. When the data
transfer is complete, dispose of
the used Patch as you would any
household battery or electronics
(please check your local electronic
waste disposal standards).
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.
TROUBLESHOOTING
PROBLEM
SOLUTION
The Patch feels hot.
Replace with a new
Patch.
The Patch no longer sticks
to your skin.
The Patch is falling apart.
The indicator light does not
flash upon push and hold.
c. Make sure to peel off the second
backing. Then smooth the
edges around the Patch with
your fingers.
ADDITIONAL INFORMATION
For further instruction on troubleshooting and
technical information, please visit:
www.proteusdigitalhealth.com/suppinfo/
ProteusPatch.pdf

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