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

Proteus Digital Health, Inc. Proteus Patch, Model SPC-0800 Users Manual1

Contents

Users Manual1

CAUTIONS
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.
ELECTROMAGNETIC & OTHER INTERFERENCES
The Patch has been tested and deemed in conformance
with the relevant requirements in EN60601-1-2:2007 Class
B for Electromagnetic Compatibility (EMC).
EQUIPMENT SYMBOLS
Batch code
Catalogue number
European Authorized Representative
Manufacturer
Read instructions before use
Type BF applied part
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
INSTRUCTIONS FOR USE
Proteus Patch
THE PATCH
PATCH BUTTON
Press and hold the
patch button for 3
seconds to initiate
communication
to Mobile Computing
Device.
INDICATOR LIGHT
A blinking green
light indicates that
communication to the
Mobile Computing Device
has begun.
Remember: Use Mobile Computing
Device to start patch change
LOT
REF
CAUTION: Investigational device.
Limited by Federal (USA) law to
investigational use.
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-0170, Rev 2 | 17DEC2013
IP27
EC REP
SPECIFICATIONS
Battery Coin cell
Data recording time 5 – 7 days
Storage conditions Original package under
normal room temperature and
humidity
Water resistant 1 meter
EC REP
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
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
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.
c. Make sure to peel off the second
backing. Then smooth the
edges around the Patch with
your fingers.
4. DISPOSE
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).
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.
TROUBLESHOOTING
PROBLEM
The Patch feels hot.
The Patch no longer sticks
to your skin.
The Patch is falling apart.
The indicator light does not
flash upon push and hold.
SOLUTION
Replace with a new
Patch.
ADDITIONAL INFORMATION
For further instruction on troubleshooting and
technical information, please visit:
www.proteusdigitalhealth.com/suppinfo/
ProteusPatch.pdf
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.

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