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Electromagnetic emissions and immunity, Emc guidance – Philips Smart ear thermometer SCH740/86 User Manual

Page 7

background image

Indicates the manufacturer's serial

number so that a specific medical device

can be identified.

Symbol for indoor use only.

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.

IP22: The first number 2: Protected against

solid foreign objects of 12,5 mm

Ф and

greater. The second number: Protected

against vertically falling water drops when

enclosure is tilted up to 15°. Vertically

falling drops shall have no harmful effects

when the enclosure is tilted at any angle

up to 15° on either side of the vertical.

–20ºC

60ºC

Indicates the storage and transportation

temperature limits to which the medical

device can be safely exposed: -20°C to

60°C.

Indicates the storage and transportation

relative humidity limits to which the

medical device can be safely exposed:

15% - 85%

Symbol for the 2 year Philips guarantee.

The Green Dot ('Der Grüne Punkt' in

German) is the license symbol of a

European network of industry-funded

systems for recycling the packaging

materials of consumer goods.

Electromagnetic emissions and

immunity

The device is approved according to EMC safety
standard EN 60601-1-2. It is designed to be used in
typical domestic environments.

EMC Guidance

- The ear thermometer needs special precautions

regarding EMC and needs to be installed and
put into service according to the EMC
information provided in this document.

- 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 d = 3.3 m
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 d = 3.3 m at an
immunity level of 3V/m.

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

Compli­

ance

Electromagnetic

environment -

guidance

RF emissions

CISPR 11

Group 1

The SCH740 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

Harmonic

emissions IEC

61000-3-2

Not

applica­

ble

Voltage

fluctua­

tions/flicker

emissions IEC

61000-3-3

Not

applica­

ble

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 specified below. The
customer or the user of the device should assure
that it is used in such an environment.

Immu­

nity

test

IEC

60601

test

level

Com­

pli­

ance

level

Electromagnetic

environment -

guidance

Electro­

static

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

floors are covered

with synthetic

material, the

relative humidity

should be at least

30%.

Power

fre­

quency

(50/60­

Hz)

magnet­

ic field

IEC

61000-­

4-8

3A/m

3A/m

Power frequency

magnetic fields

should be at levels

characteristic of a

typical location in

a typical

commercial or

hospital

environment.

This manual is related to the following products: