Otsuka America Pharmaceutical 01913 Proteus Two-part patch, Model RW2 User Manual Manual Technical
Proteus Digital Health, Inc. Proteus Two-part patch, Model RW2 Manual Technical
Contents
- 1. Manual Technical
- 2. Manual
Manual Technical
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Proteus Two-part Patch Technical description Effective: xxXXX2016
Proteus Patch
Technical Description
Table of Contents
1.Product Identification.......................................................................................................................................2
2.Manufacturer........................................................................................................................................................2
3.Indications for Use.............................................................................................................................................2
4.Description.............................................................................................................................................................2
5.Cautions And Warnings..................................................................................................................................3
6.Equipment Symbols..........................................................................................................................................4
7.Specifications.......................................................................................................................................................4
7.1.Environmental Specifications..................................................................................................................4
7.2.Compliance to IEC 60601-1....................................................................................................................5
7.3.Compliance to ANSI/AAMI EC13:2002.............................................................................................5
7.4.Compliance to other Standards.............................................................................................................5
7.5.Patch Specifications....................................................................................................................................6
7.6.Blueetooth Wireless Technology Specifications...........................................................................6
7.7.EMC Information............................................................................................................................................6
8.European R&TTE Declaration of Conformity....................................................................................10
9.FCC Declarations.............................................................................................................................................10
9.1.FCC Interference Statement.................................................................................................................10
9.2.FCC Wireless Notice.................................................................................................................................10
9.3.FCC Identifier................................................................................................................................................11
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Proteus Two-part Patch Technical description Effective: xxXXX2016
1. Product Identification
Two-Part Patch SPC-2005, SPC-2008
The Proteus Two-Part Patch is categorized as a Class II device under The Food and Drug
Administration’s regulations (in US), and as a Class IIa device, under the Medical Device Directive (in
EU).
2. Manufacturer
Proteus Digital Health, Inc
2600 Bridge Parkway
Redwood City, CA 94065
Customer Support: +1 877 285 9803
MedPass International Ltd.
Windsor House
Bretforton, Evesham
Worcestershire, WR11 7JJ, UK
3. 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 co-incidence 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.
4. Description
The two-part patch is made up of a reusable pod and a replaceable adhesive strip. The pod captures
information and sends this to an app. It can be used for weeks or months at a time. The pod is worn
on the torso using the adhesive strip. The strip contains a small coin cell battery to provide power to
the pod, and is changed weekly for comfort and a fresh battery.
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The pod measures heart rate, activity, body angle relative to gravity (body position) and the time of
ingestible sensor detection. The pod is connected with a mobile device via Bluetooth®, using a mobile
application (app), such as Proteus Discover.
Your app will prompt you when it is time to change your patch strip. Always refer to your app when
changing your strip to ensure your patch is put together correctly and connected with your mobile
device.
The patch can be worn at anytime and during all your regular activities, including showering,
exercising and on airplanes. However, after putting on a new patch avoid showering or exercising
vigorously for a few hours to allow the patch to stick properly. How long it takes for a patch to stick
varies from person to person. If your patch doesn’t stick well wait a few hours longer when applying a
new patch. Before placing, ensure the area of the skin is free of hair, dry, and healthy. Do not apply
lotion before applying a new patch.
The patch can also measure ambient temperature. It is not intended to be used as a thermometer to
measure human body temperature, and should not be used to diagnose medical conditions.
5. Cautions And Warnings
Caution: Federal (U.S.A) law restricts this device to sale by or on the order of a physician.
General
Take the ingestible sensor pill with a sufficient amount of water.
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
Do not chew.
Do not tamper with or place in water before ingestion.
Do not exceed 30 ingestions per day.
Two-part patch
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Proteus Two-part Patch Technical description Effective: xxXXX2016
Do not continue use until further instructed by a physician if your skin is irritated, inflamed, or
red 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 patch.
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 if 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.
6. Equipment Symbols
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
7. Specifications
7.1. Environmental Specifications
Temperature:
Operating, Patch: +5°C – +40°C - +41°F – 104°F
Storage/Transportation, Pod -25°C – +70°C - -13°F – +158°F
Storage/Transportation, Strip +5°C – +27°C - +41°F – +80.5°F
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Short tern (< 30 days)
Storage/Transportation, Strip +0°C – +40°C - +32°F – 104°F
Humidity
Operating, Patch: 15% - 93% (non condensing)
Storage/Transportation, Pod 15% - 93% (non condensing)
Storage/Transportation, Strip 15% - 93% (non condensing)
Altitude
Operating, Patch 700 hPa – 1060 hPa
7.2. Compliance to IEC 60601-1
The Proteus Two-part Patch has been evaluated and deemed compliant with all the applicable
requirements of:
IEC 60601-1 2005
IEC 60601-1-2 2014
IEC 60601-1-11 2010
Degree of Protection: Type BF applied Part
Protection against Electrical Shock Internally powered medical equipment
Mode of Operation Continuous
Enclosure degree of Ingress Protection IP27 (water proof to 1m – 3.3 feet) IP27
Essential Performance: The essential performance of this device is defined as
biocompatibility of the patch materials, as established by
compliance to the ISO 10993 series of standards
Use Environment The Proteus Two-part Patch is intended to be used
in the Home Healthcare environment
7.3. Compliance to ANSI/AAMI EC13:2002
The Proteus Two-part Patch has been evaluated and deemed compliant with all the applicable
requirements for heart rate meters of ANSI/AAMI EC13:2002 Cardiac monitors, hear rate meters, and
alarms
Heart Rate range: 30 to 250 bpm
Heart Rate averaging: Averaged over 14 seconds
Heart Rate response time: Up to 5 mins, depending on patch operating mode
Response to Irregular Rythms:
Ventricular Bygeminy (VB) 80 bpm
Slow Alternating VB 60 bpm
Rapid Alternating VB 120 bpm
Bidirectional Systole 90 bpm
Pacemaker pulse rejection Heart rate data may not be accurate for patients with
pacemakers
7.4. Compliance to other Standards
The Proteus Two-part Patch has been evaluated and deemed compliant with all the applicable
requirements of ISO 10993-1-2009, ISO 10993-5-2009, ISO-10993-10-2010 (Biological
evaluation of medical devices)
The Proteus Two-part Patch has been evaluated and deemed compliant with all the applicable
requirements of JIS S7200 Pedometers
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Proteus Two-part Patch Technical description Effective: xxXXX2016
This product complies with all applicable provisions of the EU Restriction of Hazardous
Substances directive (RoHS)
This product complies with all applicable provisions of the EU Medical Device Directive (MDD)
The pod and strip do not contain natural latex rubber
Strip and Pod packaging materials meet the meet transit requirements per ASTM D4169,
distribution cycle 13, Assurance Level II.
7.5. Patch Specifications
Battery (in strip) CR2016 Lithium Manganese DiOxide coin cell (3V)
Battery capacity Sufficient for at least 7 days of use
Patch memory capacity Sufficient for at least 14 days of continuous recording w/o uploads
7.6. Blutooth® Wireless Technology Specifications
Compliance Version 4.0 single mode low energy
Operating Frequency 2.4 to 2.4835 GHz
Output Power TX: -15dBm (P=0.03125mW)
Effective Bandwidth 1.25 MHz
Modulation Frequency hopping using GFSK (Gaussian Frequency Shift
Keying)
7.7. EMC Information
RF Emissions CISPR 11 Group 1
RF Environment CISPR 11 Class B
RF Interference Immunity IEC 61000-4-3 Level 3
ESD Discharge Immunity IEC 61000-4-2 Level 4
The two-part Patch uses RF energy for its internal function. Its RF emissions are
however very low and are not likely to cause any interference in nearby
electronic equipment. This device is suitable for use in all establishments,
including domestic.
The device should not be used adjacent to, or stacked with, other equipment. If adjacent or stacked use
is necessary, the device should be observed to verify normal operation in the configuration in which it
will be used.
The use of accessories, sensors, and cables other than those specified or provided by the
manufacturer of this equipment could result in increased electromagnetic emissions or decreased
electromagnetic immunity of
this equipment and result in improper operation.
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
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Proteus Two-part Patch Technical description Effective: xxXXX2016
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.
Guidance and manu
f
acturer’s declaration
–
electromagnetic emissions
The Proteus Patch is intended for use in the electromagnetic environment specified below. The
customer or the user of Proteus Patch should assure that it is used in such an environment.
Emissions test Compliance Electromagnetic environment – guidance
RF emissions
CISPR 11
Group 1
The Patch uses RF energy only for its internal function.
Therefore, its RF emissions are very low and are not likely
to cause any interference in nearby electronic equipment.
RF emissions
CISPR 11
Class B The Patch is suitable for use in all establishments,
including domestic establishments and those directly
connected to the public low voltage power supply network
that supplies buildings used for domestic purposes.
Harmonic
emissions
IEC 61000-3-2
Not applicable
Voltage
fluctuations/
flicker emissions
IEC 61000-3-3
Not applicable
Guidance and manufacturer’s declaration
–
electromagnetic immunity
The Proteus Patch is intended for use in the electromagnetic environment specified below. The
customer or the user of the Patch should assure that it is used in such an environment.
Immunity test IEC 60601 test level Compliance
level
Electromagnetic environment –
guidance
Electrostatic
discharge (ESD)
IEC 61000-4-2
+/- 8kV contact
+/- 15kV air
+/- 8kV
contact
+/- 15kV air
Floors should be wood, concrete
or ceramic tile. If floors are
covered with synthetic material,
the relative humidity should be at
least 30%.
Electrical fast
transient / burst
IEC 61000-4-4
+/- 2 kV for power
supply lines
+/- 1 kV for
input/output
lines
Not applicable
Surge IEC 61000-
4-5
+/- 1 kV line(s) to
line(s)
+/- 2 kV line(s) to earth
Not applicable
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Guidance and manufacturer’s declaration
–
electromagnetic immunity
Voltage dips, short
interruptions and
voltage variations
on power supply
input lines
IEC 61000-4-11
<5 % UT (>95 % dip in
UT)
for 0,5 cycle
40 % UT (60 % dip in
UT)
for 5 cycles
70 % UT (30 % dip in
UT)
for 25 cycles
<5 % UT (>95 % dip in
UT)
for 5 s
Not applicable
Power frequency
(50/60 Hz)
magnetic field
IEC 61000-4-8
30A/m 30A/m Power frequency magnetic fields
should be at levels characteristic
of a typical location in a typical
commercial or hospital
environment.
NOTE UT is the a.c. mains voltage prior to application of the test level.
Guidance and manufacturer’s declaration
–
electromagnetic immunity
The Proteus Patch is intended for use in the electromagnetic environment specified below. The
customer or the user of the Proteus Patch should assure that it is used in such an environment.
Immunity test IEC 60601
test level Compliance
level Electromagnetic environment –
guidance
Conducted RF
IEC 61000-4-6
Radiated RF
IEC 61000-4-3
3 Vrms
150 kHz to 80
MHz
10V/m
80 MHz to 2,5
GHz
Not Applicable
10 V/m
Portable and mobile RF
communications equipment should be
used no closer to any part of the
Proteus Patch, including cables, than
the recommended separation distance
calculated from the equation
applicable to the frequency of the
transmitter.
Recommended separation distance
Not Applicable
d = 1,17 √P 80 MHz to 800 MHz
d = 2,33 √P 800 MHz to 2,5 GHz
where P is the maximum output power
rating of the transmitter in watts (W)
according to the transmitter
manufacturer and d is the
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recommended separation distance in
metres (m).
Field strengths from fixed RF
transmitters, as determined by an
electromagnetic site survey,
a
should
be less than the compliance level in
each frequency range.
b
Interference may occur in the vicinity
of equipment marked with the
following symbol:
NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by
absorption and reflection from structures, objects and people.
a
Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones
and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be
predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF
transmitters, an electromagnetic site survey should be considered. If the measured field strength in
the location in which the Proteus Patch is used exceeds the applicable RF compliance level above,
the Proteus Patch should be observed to verify normal operation. If abnormal performance is
observed, additional measures may be necessary, such as re-orienting or relocating the Proteus
Patch.
b
Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
Recommended separation distances between portable and mobile
RF communications equipment and the Proteus Patch
The Proteus Patch is intended for use in an electromagnetic environment in which radiated RF
disturbances are controlled. The customer or the user of the Patch can help prevent electromagnetic
interference by maintaining a minimum distance between portable and mobile RF communications
equipment (transmitters) and the Proteus Patch as recommended below, according to the maximum
output power of the communications equipment.
Rated maximum output
power of transmitter
W
Separation distance according to frequency of transmitte
r
150 kHz to 80 MHz
d = 1,2 √P
80 MHz to 800 MHz
d = 1,2 √P
800 MHz to 2.5 GHz
d = 2,3 √P
0.01 Not applicable 0.1 0.23
0.1 Not applicable 0.4 0.74
1 Not applicable 1.2 2.3
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10 Not applicable 3.7 7.4
100 Not applicable 12 23
For transmitters rated at a maximum output power not listed above, the recommended separation
distance d in meters (m) can be estimated using the equation applicable to the frequency of the
transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to
the transmitter manufacturer.
NOTE 1 At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by
absorption and reflection from structures, objects and people.
8. European R&TTE Declaration of Conformity
Hereby, Proteus® Digital Health, Inc., declares that the Proteus two-part Patch is in compliance with
the essential requirements and other relevant provisions of R&TTE (Radio and Telecommunications
Terminal Equipment) Directive 1999/5/EC. The product is compliant with the following standards and/or
other normative documents:
Safety (art. 3.1a): EN 60601-1, 3rd Ed, IEC 60601-1-11
EMC (art. 3.1b): EN 301 489-17 v2.2.1
Spectrum (art.
3.2): EN 300 328 v1.8.1
Other: EN 60601-1-2 (2014)
The Proteus two-part Patch can be used in all countries in the European Union.
9. FCC Declarations
9.1. FCC Interference Statement
This device complies with Part 15 of the FCC Rules. Operation is subject to the following two
conditions: (1) this device may not cause harmful interference, and (2) this device must accept any
interference received, including interference that may cause undesired operation. Changes or
modifications not expressly approved by Proteus Digital Health could void your authority to operate the
equipment.
9.2. FCC Wireless Notice
This product emits radio frequency energy, but the radiated output power of this device is far below the
FCC radio frequency exposure limits.
Note:
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This equipment has been tested and found to comply with the limits for a Class B digital device,
pursuant to part 15 of the FCC Rules. These limits are designed to provide reasonable protection
against harmful interference in a residential installation. This equipment generates, uses and can
radiate radio frequency energy and, if not installed and used in accordance with the instructions, may
cause harmful interference to radio communications. However, there is no guarantee that interference
will not occur in a particular installation. If this equipment does cause harmful interference to radio or
television reception, which can be determined by turning the equipment off and on, the user is
encouraged to try to correct the interference by one or more of the following measures:
— Reorient or relocate the receiving antenna.
— Increase the separation between the equipment and receiver.
— Connect the equipment into an outlet on a circuit different from that to which the receiver is
connected.
— Consult the dealer or an experienced radio/TV technician for help.
9.3. FCC Identifier
FCC ID: X7901913