User manual

The blood
pressure
monitor and
mobile device
are more than
16 feet/ 5
meters away
from each
other.
Place your mobile
device closer to
the blood pressure
monitor.
You selected
the wrong
prole on
the blood
pressure
monitor.
Select the correct
user prole on the
blood pressure
monitor before
your measurement.
Otherwise the
data cannot be
transmitted to your
app. Repeat the
measurement with
the correct prole
selected
Specications
Product name
Philips Wrist blood
pressure monitor with
Bluetooth® Smart
Power supply 3.7V 420mAH built-in
rechargeable li-polymer
battery
Display Display with white
backlight
Visible area = 1 13/16" (L)
x 1 3/16" (W) / 46 mm x
30 mm
Measurement method Oscillometric method
Measurement range Rated cu pressure:
0mmHg - 300mmHg
Measurement pressure:
40mmHg - 230mmHg
heart rate: 40-199 beats
per minute
Accuracy Pressure: 41°F to 104°F
/ 5°C to 40°C within ±3
mmHg
heart rate: ±5% of
measurement result on
display
Normal operating
conditions
Temperature: 41°F to
104°F / 5°C to 40°C
Relative humidity:
≤85%RH.
Atmospheric pressure:
86kPa to 106kPa
Storage and
transportation
conditions
Temperature: -4°F to
140°F /-20°C to 60°C
Relative humidity: 10%
to 93%.
Atmospheric pressure:
50kPa to 106kPa
Measurement
perimeter of the wrist
About 5 5/16" - 8. 1/2" /
13.5 cm - 21.5 cm
Net weight
Approx. 3.5 oz / 100g
External dimensions
Approx. 3 1/8" x 2 1/2" x
1/2" / 79 mm x 64 mm x
13 mm
Accessories USB cable, user manual
Mode of operation Continuous operation
Degree of protection Type BF applied part
Protection against
ingress of water
IP22, This means:
protected against access
to hazardous parts with
a nger and against
vertically falling water
drops when tilted up to
15 degrees.
Device classication Battery Powered Mode:
Internally Powered ME
Equipment. Class II ME
Equipment
Service lifetime 5 years
Caution: No modication of this equipment is
allowed.
Explanation of symbols
The warning signs and symbols are essential
to ensure that you use this product safely and
correctly and to protect you and others from injury.
Below you nd the meaning of the warning signs
and symbols on the label and in the user manual.
Symbol for 'follow instructions for use'.
This symbol means that the part of the
device that comes into physical contact
with the user (also known as the applied
part) is of type BF (Body Floating)
according to IEC 60601-1. The applied
part is the cu.
Compliant with the Waste Electrical and
Electronic Equipment/Restriction of the
Use of Certain Hazardous Substances
in Electrical and Electronic Equipment
(WEEE) recycling directives.
Indicates manufacturing date.
Symbol for 'direct current'.
Symbol for the 'Bluetooth Combination
mark'. The device uses Bluetooth for
communication.
Indicates the manufacturer's serial
number so that a specic medical
device can be identied.
Indicates manufacturer's catalog
number of the appliance.
Fuse T1A/250V Φ3.6*10CCC.
Symbol for 'Class II Equipment'.
Symbol for indoor use only.
Symbol for 'Including RF transmitter'.
This means that this device emits
non-ionizing radiation. All devices
with RF transmitters or that use RF
electromagnetic energy must have a
label with this symbol.
Indicates caution.The user should
consult the instructions for use for
important cautionary information such
as warnings and precautions that
cannot, for a variety of reasons, be
presented on the medical device itself.
Symbol for micro-USB connector.
Symbol for USB connector.
This symbol on the device means:
protected against access to hazardous
parts with a nger and against vertically
falling water drops when tilted up to 15
degrees.
Indicates the storage and transportation
temperature limits to which the medical
device can be safely exposed: -4°F to
140°F / -20°C to 60°C.
Indicates the relative humidity limits to
which the device can be safely exposed:
10% to 93%.
Symbol for the 2 year Philips warranty.
This appliance contains a rechargeable
battery which must be disposed of
properly. See chapter ' Disposal' for
more information.
Electromagnetic emissions and
immunity
The device is approved according to EMC safety
standard IEC 60601-1-2. It is designed to be used
in typical domestic environments.
EMC Guidance
- The Blood Pressure Monitor needs special
precautions regarding EMC and needs to be
installed and put into service according to the
EMC information provided in the accompanying
documents.
- Wireless communications equipment such as
wireless home network devices, mobile phones,
cordless telephones and their base stations,
walkie-talkies can aect this equipment and
should be kept at least a distance equivalent to
3.3m (11 ft) away from the equipment.
Note: As indicated in IEC 60601-1-2:2007 for ME
equipment, a typical cell phone with a maximum
output power of 2 W yields equivalent to 3.3m
(11 ft) at an immunity level of 3V/m.
Table 1 Guidance and manufacturer‘s
declaration – electromagnetic
emissions - for all ME equipment and
ME systems
Guidance and manufacturer’s declaration –
electromagnetic emissions
The device is intended for use in the
electromagnetic environment specied below.
The customer or the user of the device should
assure that it is used in such an environment.
Emissions test Com pli-
ance
Electromagnetic
environment -
guidance
RF emissions
CISPR 11
Group 1 The device
must emit
electromagnetic
energy in order
to perform its
intended function.
Nearby electronic
equipment may be
aected.
RF emissions
CISPR 11
Class B
Harmonic
emissions IEC
61000-3-2
Not
applica-
ble
Voltage uc tu-
a tions/ick er
emissions IEC
61000-3-3
Not
applica-
ble
–4ºF
140ºF
–4ºF
140ºF
Table 2 Guidance and manufacturer‘s
declaration – electromagnetic
immunity – for all ME equipment and
ME systems
Guidance and manufacturer’s declaration –
electromagnetic immunity
The device is intended for use in the
electromagnetic environment specied below.
The customer or the user of the device should
assure that it is used in such an environment.
Immu ni-
ty test
IEC
60601
test
level
Com-
pli ance
level
Electromagnetic
environment -
guidance
Elec-
tro sta-
t ic dis-
charge
(ESD)
IEC
61000-
4-2
±6 kV
contact
±8 kV air
±6 kV
contact
±8 kV
air
Floors should be
wood, concrete
or ceramic tile. If
oors are covered
with synthetic
material, the
relative humidity
should be at least
30%.
Elec tri-
cal fast
tran-
sient/
b urst
IEC
61000-
4-4
±2 kV for
power
supply
lines
±1 kV for
input/
o ut put
lines
±2 kV
for
power
supply
lines
Electrical power
quality should be
that of a typical
commercial
or hospital
environment.
Surge
IEC
61000-
4-5
±1 kV
line(s) to
line(s)
±2 kV
line(s) to
earth
±1 kV
line(s)
to
line(s)
Electrical power
quality should be
that of a typical
commercial
or hospital
environment.
Voltage
dips,
short
inter-
rup tions
and
voltage
vari a-
tions 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
<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
Electrical power
quality should be
that of a typical
commercial
or hospital
environment. If the
user of the device
requires continued
operation
during power
interruptions, it
is recommended
that the device
be powered from
an uninterruptible
power supply or a
battery.
Power
fre-
quen cy
(50/60-
Hz)
mag-
net ic
eld IEC
61000-
4-8
3A/m 3A/m
Power frequency
magnetic elds
should be at levels
characteristic of
a typical location
in a typical
commercial
or hospital
environment.
Note: UT is the AC electrical voltage prior to
application of the test level.
Table 4 Guidance and manufacturer‘s
declaration – electromagnetic
immunity –for ME equipment
and ME systems that are not life
supporting
Guidance and manufacturer’s declaration –
electromagnetic immunity .The device is intended
for use in the electromagnetic environment
specied below. The customer or the user of the
device should assure that it is used in such an
environment.
IMMUNITY test IEC 60601 TEST
LEVEL
Compliance
level
Conducted RF
IEC 61000-4-6
3 Vrms
150 kHz to
80 MHz
3 Vrms
Radiated RF
IEC 61000-4-3
3 V/m
80 MHz to 2.5
GHz
3 V/m
Electromagnetic environment - guidance
Portable and mobile RF communications
equipment should be used no closer to any
part of the device, including cables, than the
recommended separation distance calculated
from the equation applicable to the frequency
of the transmitter.
Recommended separation distance:
d = 1.167 ÖP
d = 1.167 ÖP 80 MHz to 800MHz
d = 2.333 ÖP 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 xed 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 aected
by absorption and reection from structures,
objects and people.
(a) Field strengths from xed 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 xed RF transmitters, an electromagnetic site
survey should be considered. If the measured eld
strength in the location in which the device is used
exceeds the applicable RF compliance level above,
the device should be observed to verify normal
operation. If abnormal performance is observed,
additional measures may be necessary, such as
re-orienting or relocating the device.
(b) Over the frequency range 150 kHz to 80 MHz,
eld strengths should be less than 3V/m.
Table 6 Recommended separation
distances between portable
and mobile RF communications
equipment and the ME equipment
or ME system – for ME equipment
and ME systems that are not life
supporting
Recommended separation distances between
portable and mobile RF communications
equipment and the device.
The device is intended for use in an
electromagnetic environment in which radiated
RF disturbances are controlled. The customer
or the user of the device can help prevent
electromagnetic interference by maintaining a
minimum distance between portable and mobile
RF communications equipment (transmitters) and
the device as recommended below, according to
the maximum output power of the communications
equipment.
Separation distance according to
frequency of transmitter (m)
Rated
maximum
output
power of
transmitter
(W)
150 kHz to
80 MHz
d = 1.167
Ö P
80 MHz
to 800
MHz
d = 1.167
Ö P
800 MHz
to 2.5 GHz
d = 2.333
0.01
0.117
0.117 0.233
0.1 0.369 0.369 0.738
1 1.167 1.167 2.333
10 3.690 3.690 7.378
100
11.67
11.67
23.33
For transmitters rated at a maximum output power
not listed above, the recommended separation
distance d in metres (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 80MHz and 800MHz, the separation
distance for the higher frequency range applies.
NOTE 2 These guidelines may not apply in all
situations. Electromagnetic propagation is aected
by absorption and reection from structures,
objects and people.
FCC Compliance information
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.
FCC ID 2AEFK-DL8765
Radio interference
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 o 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 to an outlet on a circuit
dierent from that to which the receiver is
connected.
- Consult the dealer or an experienced radio/TV
technician for help.
RF Radiation exposure statement
This equipment complies with FCC RF radiation
exposure limits set forth for an uncontrolled
environment. For handheld/body-worn operation,
this equipment has been tested and meets the
FCC RF exposure guidelines. This transmitter must
not be co-located or operating in conjunction with
any other antenna or transmitter. Use of other
accessories may not ensure compliance with FCC
RF guidelines.
Do not attempt to repair or modify this equipment.
Any repairs or alterations made by the user to the
equipment may void the warranty and compliance
of the equipment. Changes or modications made
to this equipment not expressly approved by
Philips may void the FCC authorization to operate
this equipment. For assistance visit our website
www.philips.com/support or call toll-free
1-844-531-6861.
BlueTooth wordmark
The BlueTooth® Smart wordmark and logos are
registered trademarks owned by Bluetooth SIG,
Inc. and any use of such marks by Philips is under
license.
App Store and iPhone
App Store and iPhone are trademarks of Apple
Inc., registered in the U.S. and other countries. App
Store is a service mark of Apple Inc.
Google Play and Android
Google Play and Android are trademarks of Google
Inc.
The numbers in the gures below refer to
gure numbers between brackets in the
text.
12
5
7
9
1011
6
8
1 2
3 4
13
14
15
16 17
1 - 2 cm
"- ¾"
1
2
32
4222.100.5748.1 (02/2016)
1
www.philips.com
Specications are subject to change without notice.
© 2016 Koninklijke Philips N.V.
All rights reserved
Manufactured for:
Philips Consumer Lifestyle
A division of Philips Electronics North America
Corporation
P.O. Box 10313, Stamford, CT 06904
4
1098
75 6
13
16
19
11
14
17
12
15
18
4222_100_5748_1_A7_8x4_592x420mm_64p_v1.indd 1 12/02/16 16:18