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Device classification
Caution: No modification 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 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)
according to IEC 60601-1. The applied
part is the cuff.
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 specific medical device
can be identified.
Indicates manufacturer's catalog number
of the appliance.
Fuse T1A/250V Φ3.6*10CCC.
Symbol for 'Class II Equipment'. The DC
charger is double insulated (Class II) and
complies with IEC 60601-1.
Symbol for indoor use only.
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.
This symbol on the device means:
protected 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
140ºF
temperature limits to which the medical
–4ºF
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 affect 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 specified below. The
customer or the user of the device should assure
that it is used in such an environment.
Emissions test
RF emissions
CISPR 11
Battery Powered Mode:
Internally Powered ME
Equipment. DC charger
charged mode: Class II
ME Equipment
Com
Electromagnetic
pliance
environment -
guidance
Group 1 The device must emit
electromagnetic
energy in order to
perform its intended
function. Nearby
electronic equipment
may be affected.
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