Otsuka America Pharmaceutical 01913 Proteus Two-part patch, Model RW2 User Manual Manual

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Document ID	3127850
Application ID	ZBpd4gwypYLytXfSLz18LA==
Document Description	Manual
Short Term Confidential	No
Permanent Confidential	No
Supercede	No
Document Type	User Manual
Display Format	Adobe Acrobat PDF - pdf
Filesize	14.45kB (180600 bits)
Date Submitted	2016-09-08 00:00:00
Date Available	2016-09-08 00:00:00
Creation Date	2016-06-07 11:46:10
Producing Software	Adobe PDF Library 15.0
Document Lastmod	2016-06-07 11:46:11
Document Title	Manual
Document Creator	Adobe InDesign CC 2015 (Macintosh)

Patch specifications
Battery
Follow the instructions
in your app to put
your patch together,
connect it with your
mobile device, and
place it on your body.
Patch
Pod
Coin Cell
Strip Wear Duration:
Approximately 7 days
Storage Conditions:
Degree of Ingress
Protection:
Protection against
Electrical Shock:
Degree of Protection:
Original package under
normal room temperature
and humidity.
IP27 (Water resistant to
3.3 feet or 1 meter)
Internally powered
medical equipment
Type BF Applied Part
Mode of Operation:
Continuous
• This product complies with ISO 10993-1-2009,
ISO 10993-5-2009, and ISO 01993-10-2010
• This product complies with IEC 60601-1-2005,
IEC 60601-1-2-2014, IEC 60601-1-11-2010
• This device has no essential performance
• This product complies with RoHS
• The pod and strip do not contain natural latex rubber
Ingestible sensor pill
Strip
Your patch is made up of a pod and disposable strip.
The pod can be used for weeks or months at a time.
It captures and sends information to your mobile
application (app). The disposable strip is changed
weekly. It sticks to the skin on your torso and contains a
small battery that powers the pod.
Your patch measures heart rate, activity, body position,
and when an ingestible sensor is detected. When taken
with an ingestible sensor, you can see the pattern and
regularity of how you take your medications. You can
also see your sleep patterns by analyzing activity and
body position over time. You can use your app to view
your data and keep track of how you are doing.
Your patch can also measure ambient temperature.
It is not intended to be used to measure human body
temperature, and should not be used to diagnose
medical conditions.
The data collected are securely transferred and then
stored in Proteus’ databases.
Your patch can be worn during most activities, including
showering, exercising and on airplanes. However, after
putting on a new strip avoid showering or exercising
vigorously for a few hours to allow the strip to stick
properly. How long it takes for a strip to stick varies
from person to person. If your strip doesn’t stick well
the first time wait a few hours longer when applying
your next one. Before placing a strip on your body,
ensure the area of the skin is free of hair, dry, and
healthy. Do not apply lotion before applying a new strip.
Clean your pod using household soap and water. You
can rinse your pod under running water.
Strip disposal
Your strip contains the batteries that power the patch.
Dispose of your used strip in a sanitary fashion, and
in the same way as you would household batteries or
electronics (please check local electronic waste
disposal standards). Do not throw out the pod. Keep the
pod for reuse.
The ingestible sensor pill contains a tiny ingestible
sensor made out of ingredients found in dietary
supplements. The ingestible sensor sends a signal to
the patch after it reaches your stomach.
Indications for use
The Proteus® Digital Health Feedback Device consists
of a miniaturized, wearable sensor (Proteus Patch) for
ambulatory recording of physiological and behavioral
metrics such as heart rate, activity, body angle relative
to gravity (body position), and time-stamped patient
logged events, including events signaled by the coincidence with, or co-ingestion with, the ingestible
sensor accessory. When the ingestible sensor is
ingested, the Proteus Digital Health Feedback Device
is intended to log, track and trend intake times. When
co-ingested with medication, the tracking and trending
of intake times may be used as an aid to measure
medication adherence. The Proteus Digital Health
Feedback Device may be used in any instance where
quantifiable analysis of event associated physiological
and behavioral metrics is desirable, and enables
unattended data collection for clinical and research
applications.
Safety and performance
The ingestible sensor was extensively tested in clinical
studies. Overall, 492 volunteers (Age range 21–85,
Mean: 44.6) participated in the wearable sensor
studies representing 6,407 wearable sensor-use days.
During these studies, 412 of these volunteers also
took ingestible sensors representing 5,656 ingestion
days (total of 20,993 ingestible sensor ingestions).
No serious adverse events were observed in these
clinical studies. Adverse events that occurred in ≥ 1%
of study subjects are detailed as follows. Sixty-one
(12.4%) of the study subjects experienced self-limited
skin rashes localized at the site of wearable sensor
placement. In the ingestion studies, four subjects
(1.0%) reported nausea/vomiting which were possibly
related to the ingestible sensor. In comparison with
direct observation, the ingestible sensor was detected
in 97.3% of ingestions, with 100% correct identification.
In other words, one out of every 37 sensors may not be
detected due to reasons other than non-adherence.
Cautions
Troubleshooting
Equipment symbols
General
If you experience difficulties in operating your patches or
sample ingestible sensors, refer to the troubleshooting
tables below or contact customer support.
LOT
• Check the component expiration dates before use.
• Keep components out of reach of children.
• DO NOT store components in extremely hot, cold,
humid or bright conditions.
• DO NOT use as sole basis for medication treatment
decisions. Detection accuracy is less than 100%.
Patients instructed by a physician to take an
Ingestible Sensor with medication may selectively
adhere to one or the other. Therefore, Ingestible
Sensor data should be interpreted with caution.
Physicians should discuss medication-taking history
with patients prior to making medication changes.
• Proteus Digital Health makes no warranty for any
data or information that is collected erroneously
by the ingestible sensor and/or patch, or misuse
or malfunction as a result of abuse, accidents,
alteration, misuse, neglect, or failure to maintain the
products as instructed. Users of the ingestible sensor
and/or patch who experience clinical worsening
or new clinical symptoms should seek medical
attention. Healthcare providers should exercise
their clinical judgment in interpreting and using any
data from ingestible sensor and/or patch for clinical
decision-making.
• Heart rate data may not be accurate for patients with
pacemakers
Ingestible sensor pill
• Take the ingestible sensor pill with a sufficient
amount of water.
• DO NOT chew.
• DO NOT tamper with or place in water before
ingestion.
• DO NOT exceed 30 ingestions per day.
Strip
• DO NOT continue use until further instructed by a
physician if your skin is irritated, inflamed, or red
around the disposable 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 strip.
• DO NOT use if you are allergic to adhesive tape.
• DO NOT drop or bump with excessive force.
• DO NOT use to diagnose heart-related conditions.
• DO NOT wear during magnetic resonance imaging
(MRI), cautery and external defibrillation procedures.
• DO NOT dispose of strips with household waste
• DO NOT throw out the pod: keep it for use with your
next strip
• Pod may pose a choking hazard to children under 3
years of age.
• Patch does not contain medication.
• The device contains no serviceable parts or
components
• Replace the strip about once per week or as
prompted by mobile app.
• Warning: No modification of this equipment is
allowed. Modifying the Proteus Patch may cause a
safety hazard for the user.
Additional information
For more detailed technical information, please visit:
www.proteus.com/instructions
REF
EC REP
Problem
Solution
You have visible skin
changes, e.g. rash
or blistering, around
the strip.
Remove your patch from your
torso, remove the pod from the
strip, and set pod aside. Seek
medical attention. Do not use
another patch until told to do so
by your healthcare provider.
Problem
Solution
Your patch is itchy or
uncomfortable
(no visible skin
changes).
Remove your patch from your
torso, remove the pod from the
strip, place the pod into a new
strip, and attach the new patch to
your torso in a new location.
Problem
Solution
Your patch no
longer sticks to
your skin.
Remove the pod from the strip,
place the pod into a new strip,
and place the new patch on your
body. The “Patch” section on the
left-hand side of this document
contains further information.
Pod
Problem
Solution
The green light does
not appear when the
pod is placed in the
strip.
Confirm that the pod and strip
are put together correctly. If
the green light still does not
appear, replace the strip. If the
green light still does not appear,
contact Customer Support.
Patch
SN
Problem
Solution
You have misplaced
your pod.
If you cannot find your pod,
contact Customer Support.
IP27
Batch code
Serial number
Catalog 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-DD
Do not dispose with household waste
Ingress Protection rating of IP27
General warning
Customer support
Phone: +1 855.255.5858
Email: helpdesk@proteus-support.com
Proteus Digital Health, Inc.
2600 Bridge Parkway
Redwood City, CA 94065, USA
T +1-650-632-4031
EC REP MedPass International Ltd.
Windsor House
Bretforton, Evesham
Worcestershire, WR11 7JJ, UK
0086
LBL-0XXX, Rev X, DDMMMYYYY
CAUTION
Federal (USA) law restricts this device to sale by or on
the order of a physician.
Ingestible sensor pill
Problem
Solution
The pill gets wet or
damaged.
Do not take. Swallow a
replacement pill if provided
The patch needs special precautions regarding EMC
and needs to be installed and put into service according
to the EMC information provided in this document.
WARNING: Portable and mobile RF communications
equipment can affect the Patch. Portable and mobile F
communications equipment (including peripherals such
as antenna cables and external antennas) should be
used no closer than 30 cm (12 inches) to any part of the
Patch. Otherwise, degradation of the performance of
the Patch could result.
Instructions for Use
Patch and Ingestible
Sensor Pills

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