Proteus Digital Health 06550 Proteus Wearable Sensor Module, Model SPC-0655 User Manual 2

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Document ID	2102275
Application ID	9zYOs03sw/opCRqJE7iIQw==
Document Description	Users Manual 2
Short Term Confidential	No
Permanent Confidential	No
Supercede	No
Document Type	User Manual
Display Format	Adobe Acrobat PDF - pdf
Filesize	10.33kB (129122 bits)
Date Submitted	2013-10-25 00:00:00
Date Available	2013-10-25 00:00:00
Creation Date	2013-10-01 14:44:37
Producing Software	Acrobat Distiller 8.3.1 (Windows)
Document Lastmod	2013-10-01 14:44:37
Document Title	Microsoft Word - LBL-0151 RW1 Extended-Use Patch User Supplemental Information Draft.doc
Document Creator	PScript5.dll Version 5.2.2
Document Author:	dguidotti

THE PROTEUS Extended-Use PATCH
SPC-0655
USER SUPPLEMENTAL INFORMATION
Table of Contents
1. TECHNICAL INFORMATION ............................................................................................................ 2
1.1 – Classification ................................................................................................................................. 2
1.2 – Environmental Conditions .................................................................................................... 2
1.3 – Minimizing Skin Irritation ...................................................................................................... 2
1.4 – Protection against Ingress of Solids and Liquids ...................................................... 2
1.5 – Avoiding Unsafe Use Conditions ........................................................................................ 3
1.6 – Information on Electromagnetic and Other Interferences .................................. 3
1.7 – Information on the Radio Subsystem ............................................................................... 3
1.8 – European R&TTE Declaration of Conformity ............................................................... 8
1.9 – CISPR Interference Statement ............................................................................................. 8
1.10 – FCC Interference Statement .............................................................................................. 8
1.11 – FCC Wireless Notice ................................................................................................................ 8
1.12 – FCC Identifier ............................................................................................................................. 9
2 – DISPOSAL OF WASTE PRODUCTS .............................................................................................. 8
3 – MANUFACTURER CONTACT INFORMATION ........................................................................ 9
LBL-0151 | User Supplemental Information,
Extended-Use PATCH
Effective: xxXXX2013
1. TECHNICAL INFORMATION
1.1 – Classification
Caution: Federal (U.S.A) law restricts this device to sale by or on the order of a physician.
The Proteus Patch is categorized as Class II (in US) and IIa (in EU).
The User (patient) is the intended Operator of the Proteus Patch.
1.2 – Environmental Conditions
The Proteus® Patch is intended for storage and operation in a room-temperature
environment. Do not subject the Proteus Patch to transport conditions for more than 7
days.
Condition:
Temperature
Humidity
Operating
Storage
Transport
20C – 30C
20C – 28C
2C – 38C
15% - 93%
15% - 93%
15% - 85%
Pressure
(Altitude)
700 hPa – 1060 hPa
700 hPa – 1060 hPa
700 hPa – 1060 hPa
1.3 – Minimizing Skin Irritation
The Proteus Patch has been designed to minimize the possibility of skin irritation.
Observing these cautions will reduce the likelihood of skin irritation or bruising under 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 more than one week.
DO NOT drop or bump with excessive force.
1.4 – Protection against Ingress of Solids and Liquids
The Proteus Patch has an Ingress Protection rating of IP27. This means that the enclosure
has no penetrations and it has been rated for immersion in liquid up to 1m depth. For
LBL-0151 | User Supplemental Information,
Extended-Use PATCH
Effective: xxXXX2013
continued safety, should the enclosure become penetrated or torn, remove the Patch
immediately and replace it with a new one.
1.5 – Avoiding Unsafe Use Conditions
The Proteus Patch is not a diagnostic device. DO NOT attempt to use it to diagnose heartrelated conditions, an incorrect diagnosis may result.
The Proteus Patch has not been tested or approved as safe for operation during air travel.
DO NOT use the Patch during air travel; it may interfere with the aircraft navigational
instruments.
The Proteus Patch has not been tested or approved for use in the presence of strong
magnetic or electric fields. DO NOT wear the Patch during magnetic resonance imaging
(MRI), cautery, and external defibrillation procedures. Damage to the Patch, your skin, or
an unexpected magnetic attraction may result. Please inform your healthcare professional
that the Patch must be removed prior to engaging in one of these procedures.
WARNING: No modification of this equipment is allowed. Modifying the Proteus Patch may
cause a safety hazard for the user.
1.6 – Information on Electromagnetic and Other Interferences
The Proteus Patch has been evaluated and deemed compliant with the requirements in
EN60601-1-2 Class B for Electromagnetic Compatibility (EMC). Medical Electrical
Equipment needs special precautions regarding EMC and needs to be installed and put into
service according to the EMC information provided in this User Manual. Portable and
mobile RF communications equipment can affect Medical Electrical Equipment. The
Proteus Patch should not be used adjacent to or stacked with other electromagnetic
equipment. If adjacent or stacked use with other electromagnetic equipment is necessary,
verify that the Proteus Patch operation is normal in the configuration(s) in which it will be
used.
1.7 – Information on the Radio Subsystem
The Proteus Patch incorporates a BluetoothTm radio subsystem which is compliant with the
Bluetooth standard. The following information is provided to satisfy the requirements of
EN/IEC 60601-1-2:
The Bluetooth radio transmits and receives on 40 frequency bands which are equally
spaced at 2MHz intervals between 2402MHz and 2480MHz.
The effective receive bandwidth is 1.25MHz.
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The transmit modulation is frequency-hopping using GFSK (Gaussian Frequency Shift
Keying) with a bandwidth-bit period product BT=0.5. The Modulation index is between
0.28 and 0.35.
The effective radiated power is -15dBm ( P = 0.032mW )
Guidance and manufacturer’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 ensure that it is used in such
an environment.
Emissions test
Compliance
Electromagnetic environment – guidance
RF emissions
Group 1
The Patch uses RF energy only for its internal
CISPR 11
function. Therefore, its RF emissions are very low
and are not likely to cause any interference in
nearby electronic equipment.
RF emissions
Class B
The Patch is suitable for use in all establishments,
CISPR 11
including domestic establishments and those
directly connected to the public low voltage
Harmonic
Not applicable
power supply network that supplies buildings used
emissions
for domestic purposes.
IEC 61000-3-2
Voltage
Not applicable
fluctuations/
flicker
emissions
IEC 61000-3-3
LBL-0151 | User Supplemental Information,
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Effective: xxXXX2013
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 ensure that it is used in such an
environment.
Immunity test
IEC 60601 test level
Compliance
Electromagnetic
level
environment – guidance
+/- 6kV
Electrostatic
+/- 6kV contact
Floors should be wood,
+/- 8kV air
discharge (ESD)
contact
concrete or ceramic tile. If
IEC 61000-4-2
+/- 8kV air
floors are covered with
synthetic material, the
relative humidity should be
at least 30%.
Not
Electrical fast
+/- 2 kV for power
supply lines
applicable
transient / burst
+/- 1 kV for
IEC 61000-4-4
input/output
lines
Not
Surge IEC 61000+/- 1 kV line(s) to
line(s)
applicable
4-5
+/- 2 kV line(s) to
earth
Voltage dips,
<5 % UT (>95 % dip in
Not
short
applicable
UT)
interruptions and for 0,5 cycle
voltage variations 40 % UT (60 % dip in
on power supply
UT)
input lines
for 5 cycles
IEC 61000-4-11
70 % UT (30 % dip in
UT)
for 25 cycles
<5 % UT (>95 % dip in
UT)
for 5 s
Power frequency
3A/m
3A/m
Power frequency magnetic
(50/60 Hz)
fields should be at levels
magnetic field
characteristic of a typical
IEC 61000-4-8
location in a typical
commercial or hospital
environment.
NOTE UT is the a.c. mains voltage prior to application of the test level.
LBL-0151 | User Supplemental Information,
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Effective: xxXXX2013
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 ensure that it is used in such
an environment.
Immunity test
IEC 60601
Compliance
Electromagnetic environment –
test level
level
guidance
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.
Conducted RF
IEC 61000-4-6
Radiated RF
IEC 61000-4-3
3 Vrms
150 kHz to 80
MHz
Not
Applicable
3 V/m
80 MHz to 2,5
GHz
3 V/m
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 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
LBL-0151 | User Supplemental Information,
Extended-Use PATCH
Effective: xxXXX2013
affected by absorption and reflection from structures, objects and people.
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.
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
Separation distance according to frequency of transmitter
output power of
80 MHz to 800 MHz 800 MHz to 2.5 GHz
150 kHz to 80 MHz
transmitter
d = 1,2 √P
d = 1,2 √P
d = 2,3 √P
0.01
Not applicable
0.1
0.23
0.1
Not applicable
0.4
0.74
Not applicable
1.2
2.3
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.
LBL-0151 | User Supplemental Information,
Extended-Use PATCH
Effective: xxXXX2013
1.8 – European R&TTE Declaration of Conformity
Hereby, Proteus® Digital Health, Inc., declares that the Proteus 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):
EMC (art. 3.1b):
Spectrum (art.
3.2):
Other:
EN 60601-1, 3rd Ed, IEC 60601-1-11
EN 301 489-17 v2.2.1
EN 300 328 v1.8.1
EN 60601-1-2 (2007)
The Proteus Patch can be used in countries in the European Union.
1.9 – CISPR Interference Statement
MEDICAL ELECTRICAL EQUIPMENT needs special precautions regarding EMC and needs to be
installed and put into service according to the EMC information provided in this section of
the manual. Portable and mobile RF communications equipment can affect MEDICAL
ELECTRICAL EQUIPMENT. The Proteus Patch may be interfered with by other equipment,
even if that equipment complies with CISPR emission requirements.
1.10 – 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.
1.11 – 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:
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
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Effective: xxXXX2013
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.
1.12 – FCC Identifier
FCC ID: X7906550
2 – DISPOSAL OF WASTE PRODUCTS
Production of this equipment required the extraction and use of natural resources. The
equipment may contain substances that could be harmful to the environment or human
health if improperly handled at the product’s end of life. In order to avoid release of such
substances into the environment and to reduce the use of natural resources, all devices,
LBL-0151 | User Supplemental Information,
Extended-Use PATCH
Effective: xxXXX2013
both used and unused, should not be disposed with household waste. Return to a recycling
point for electric and electronic devices.
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3 – MANUFACTURER CONTACT INFORMATION
To request technical information or to report unexpected events, please contact the
manufacturer at one of these locations.
United States
Proteus Digital Health, Inc
2600 Bridge Parkway, Suite 101
Redwood City, CA 94065
United Kingdom
Proteus Digital Health UK Ltd
6th Floor, 41-44 Great Queen St.
London WC2B 5AD
Phone Number: 650-632-4031
Fax Number: 650-632-4071
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LBL-0151 | User Supplemental Information,
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Extended-Use PATCH
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