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General
The Philips upper arm blood pressure monitor with
Bluetooth® enables you to perform blood pressure
measurements, heart rate (pulse) measurements,
transmit data via Bluetooth® to your mobile device
and display your personal measurement results in
the Philips HealthSuite health app. The device can
also be used as a standalone device.
This user manual contains important safety infor
mation and provides step-by-step instructions for
using the blood pressure monitor.
Read this information carefully before you use the
device and save it for future reference.
Features:
- 86.5mm×24mm display with white backlight
- Measure-during-inflation technology
- Supports 2 users
Intended use
The Philips upper arm blood pressure monitor is a
digital monitor intended for use in measuring blood
pressure and heart rate in adult patient population
with arm circumference ranging from 22cm to
42cm (about 9-17 inches). The device is intended
to be used in a home environment.
The warning signs and symbols are essential to
ensure that you use this product safely and cor
rectly and to protect you and others from injury.
Below you find 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) accord
ing to IEC 60601-1. The applied part is the
cuff.
Symbol for 'the device complies with
European Medical Device Directive
93/42/EEC requirements'. 0344 refers to
the notified body.
Symbol for WEEE, waste electrical and
electronical equipment. Electrical waste
products should not be disposed of with
household waste. Please recycle where
facilities exist. Check with your local
authority or retailer for recycling advice
and see chapter 'Battery recycling'.
This symbol means that this product con
tains batteries which shall not be disposed
of with normal household waste
(2006/66/EC).
Indicates the manufacturer, as defined in
EU Directives 93/42/EEC.
Indicates manufacturing date.
Symbol for 'direct current'.
Symbol for the 'Bluetooth Combination
mark'. The device uses Bluetooth for com
munication.
Indicates the manufacturer's batch code.
Indicates the manufacturer's serial num
ber so that a specific medical device can
be identified.
Fuse T1A/250V Φ3.6*10CCC.
Symbol for 'Class II Equipment'. The
adapter is double insulated (Class II) and
complies with IEC 60601-1.
Symbol for indoor use only.
Symbol for 'Including RF transmitter'. This
–20ºC
60ºC
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 cau
tionary information such as warnings and
precautions that cannot, for a variety of
reasons, be presented on the medical
device itself.
This symbol on the device means: pro
tected against access to hazardous parts
with a finger 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: -20°C to
60°C.
Symbol for the 2 year Philips guarantee.
The Green Dot ('Der Grüne Punkt' in Ger
man) is the license symbol of a European
network of industry-funded systems for
recycling the packaging materials of con
sumer goods.
This symbol on the DC charger indicates
that it is TUV certified.
General description (Fig. 1)
1 Socket for DC charger plug
2 Bluetooth® symbol
3 Battery symbol
4 Systolic blood pressure
5 Diastolic blood pressure
6 Heart rate
7 Movement detector
8 Heart rate/irregular heart rate detector
9 User IDs
10 Cuff
11 On button
12 User ID button
13 Blood pressure classification
14 DC plug
15 DC charger
Important safety information
Read this important information carefully before
you use the device and save it for future reference.
Warning
- Please keep the unit out of reach of infants,
children or pets, since inhalation or swallowing
of small parts can be dangerous or even fatal.
- The device is not suitable for measuring the
blood pressure of children.
- The device is not suitable for persons who have
electrical implants.
- Do not use this blood pressure monitor on any
arm where intravascular access or therapy
(such as an intravenous drip or a blood transfu
sion), or an arterio-venous shunt (A-V shunt) is
present. The temporary interference to blood
flow by the blood pressure measurement could
result in injury.
- If you had a mastectomy (breast amputation)
do not use this blood pressure monitor on the
arm on the side of the mastectomy. The inflat
ing cuff can lead to pain, trauma and further
injury in the arm on the side of the mastectomy.
- Consult your doctor if your suffer from illnesses
prior to using the device.
- No modifications of this equipment are allowed.
This may result in increased emissions or
decreased immunity of the device.
- Do not use the blood pressure monitor during
charging as this can cause injury.
- Do not touch the output of the adapter as this
can cause injury.
- Do not dispose of batteries in fire. Battery may
explode or leak.
- If you experience discomfort during a measure
ment, such as pain in the arm or other com
plaints, press the 'on' button to release the air
immediately from the cuff. Loosen the cuff and
remove it from your arm.
- On the rare occasion of a fault causing the cuff
to remain fully inflated during measurement,
open the cuff immediately. Prolonged high
pressure (cuff pressure >300mmHg or constant
pressure >15mmHg for more than 3 minutes)
applied to the arm, may lead to bruises (ecchy
mosis).
- Too frequent and consecutive measurements
could cause disturbances in blood circulation
and injuries.
- Beware of strangulation, particularly for children
and infants due to cables.
- Do not connect the tube to other medical
equipment, as this could lead to dangerous
injuries.
- This device is not intended for patients outside
a home environment.
- Never use any accessories or parts from other
manufacturers or that Philips does not specifi
cally recommend. Using such accessories or
parts could cause a hazardous situation for the
user or damage to the device.
- Only use the accessories and detachable parts
authorized by the manufacturer. The use of
unauthorized parts or accessories may cause
damage to the device or injury to the user.
Caution
- Always check the device before you use it. Do
not use the device if it is damaged, as this may
cause injury.
- The effectiveness of this blood pressure moni
tor has not been established in pregnant
(including pre-eclamptic) women.
- Common arrhythmias (such as atrial or ventric
ular premature beats or atrial fibrillation) and
peripheral artery disease / arteriosclerosis can
affect the performance (accuracy) of this blood
pressure monitor. Please consult your doctor
how to best use this blood pressure monitor if
you suffer from any of these conditions.
- Only use this device for its intended purpose as
described in this user manual.
- Do not confuse self-monitoring with self-diag
nosis. This device allows you to monitor your
blood pressure. Do not begin or end medical
treatment based on the measurement results.
Always consult your doctor for treatment
advice.
- Do not take any therapeutic measures on the
basis of a self-measurement. Never change
prescribed medication without consulting your
doctor. Consult your doctor if you have any
questions about your blood pressure.
- If you are taking medication, consult your
physician to determine the most appropriate
time to measure your blood pressure.
- This device is not intended for use on extremi
ties other than the arm or for functions other
than obtaining a blood pressure measurement.
- If the cuff pressure exceeds 40kPa (300mmHg),
the unit will deflate automatically. If the cuff
does not deflate when pressures exceeds
40kPa (300mmHg), detach the cuff from the
arm and press the 'on' button to stop inflation.
- Do not attach the cuff on the same arm on
which other monitoring medical electrical
equipment is attached simultaneously, because
this could cause temporary loss of function of
those simultaneously-used monitoring medical
electrical equipment.
- Never attach the cuff on injured skin, an injured
arm or an arm under medical treatment as this
can cause further injury.
- Do not use the device in case of existing poly
ester or nylon material allergies.
- This device is not washable. Never immerse the
device in water and do not rinse it under the
tap.
- This device is not suitable for continuous moni
toring during medical emergencies or opera
tions.
- This device cannot be used with HF (High Fre
quency) surgical equipment at the same time.
- Never use compressed air, scouring pads, abra
sive cleaning agents or aggressive liquids such
as petrol or acetone to clean the device.
- Do not use the adapter in or near wall sockets
that contain or have contained an electric air
freshener to prevent irreparable damage to the
adapter.
- If the battery can no longer be recharged or
when the device does not function properly
anymore (see 'Specifications'), please contact
the Philips Consumer Care center in your coun
try.
- Keep the device away from fire and heat
sources, as the battery can overheat, causing
fire or bursting. The battery could explode
causing injury or death.
- After charging, remove the small plug from the
device and remove the adapter from the wall
socket.
- The equipment is not AP/APG equipment and
is not suitable for use in the presence of a flam
mable anesthetic mixture with air, with oxygen
or nitrous oxide.
- To avoid measurement errors, do not use the
device near strong electrical or magnetic fields,
for example magnets, radio transmitters,
microwave ovens.
- To avoid measurement errors, do not use the
device near a strong electromagnetic field radi
ated interference signal or electrical fast tran
sient/burst signal.
- Use this device under the right environmental
conditions as indicated in this user manual. If
not, this could affect the performance, lifetime
of the device and measurement results.
- Use a soft cloth to clean the whole unit. Do not
use any abrasive or volatile cleaners.
- Only use the DC charger supplied (model: AC
power adapter KH0601000EW) to charge the
device.
- The device does not need to be calibrated for
two years of normal use. After two years the
measurements may become less accurate.
- If you have any problems with this device, such
as setting up, malfunction, maintaining or using,
please contact Philips Consumer Care.
- Do not open, disassemble or repair the device
yourself. Modification of the device voids your
warranty.
- Report to Philips Consumer Care if any unex
pected operation or events occur.
- Dispose of accessories, detachable parts, and
the ME equipment according to the local guide
lines.
- Do not attempt to replace your blood pressure
monitor's battery. It is built-in and not change
able.
- Avoid charging your blood pressure monitor in
extremely high or low temperatures (see 'Speci
fications').
- Do not clean the blood pressure monitor when
it is being charged. Always unplug the charger
first before cleaning the blood pressure moni
tor.
Compliance with standards
- The device meets the relevant standards for this
type of Class IIa electrical medical equipment
for home use.
- This Philips device complies with all applicable
standards and regulations regarding exposure
to electromagnetic fields and complies with EN
60601-1-2.
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