Symbol Descriptions; Manufacturer's Declaration - Electromagnetic Emissions; Manufacturer’s Declaration - Electromagnetic Immunity - ETI 801-590 Operating Instructions

SYMBOL DESCRIPTIONS

Warning: No modification of
this equipment is allowed
BF type applied part
Classification for water
ingress and particulate matter
The non-contact forehead thermometer is intended for use in the electromagnetic environment (for home healthcare) specified below. The
customer or the user of the non-contact forehead thermometer should assure that it is used in such an environment.
Emissions test
RF emissions
CISPR 11
RF emissions
CISPR 11
The non-contact forehead thermometer is intended for use in the electromagnetic environment (for home healthcare) specified below. The
customer or the user of the non-contact forehead thermometer should assure that it is used in such an environment.
Immunity test
Electrostatic discharge (ESD)
IEC 61000-4-2
Power frequency (50, 60 Hz)
magnetic field IEC 61000-4- 8
The non-contact forehead thermometer is intended for use in the electromagnetic environment (for home healthcare) specified below. The
customer or the user of the non-contact forehead thermometer should assure that it is used in such an environment.
Immunity test IEC 60601 test level
10 V/m
Radiated RF
80 MHz – 2,7 GHz
IEC 61000 -4- 3
80 % AM at 1 kHz
NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies.
These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection
NOTE 2
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
non-contact forehead thermometer is used exceeds the applicable RF compliance level above, the non-contact forehead thermometer should
be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or
relocating the non-contact forehead thermometer.
Please read the
instructions for use
Paper recycling
The CE mark and Notified
Body Registration Numbers,
the requirement of Annex II
from Medical Device Directive
93/42/EEC are met.
Manufacturer's declaration
Compliance
The unit uses RF energy only for its internal function. Therefore, its RF emissions are very
Group 1
low and are not likely to cause any interference in nearby electronic equipment.
The non-contact forehead thermometer is suitable for use in all establishments, including
domestic establishments and those directly connected to the public low-voltage power
Class B
supply network that supplies buildings used for domestic purposes.
Manufacturer's declaration – electromagnetic immunity
Compliance level
IEC 60601 test level
Contact : ±8 kV Contact : ±8 kV
Air±2 kV,±4 kV,±8 Air±2 kV,±4 kV,±8
WAND is intended for use in the electromagnetic environment (
kV,±15 kV kV,±15 Kv
30 A/m 30 A/m
Emissions test C ompliance
50 Hz or 60 Hz 50 Hz and 60 Hz
RF emissions Group 1 WAND uses RF energy only for its internal function. Therefore, its RF emissions are very low and a
RF emissions Class B
Manufacturer's declaration – electromagnetic immunity
Compliance
WAND is intended for use in the electromagnetic environment (for home healthcare) specified below. The customer or the user
level
Recommended separation distance:
d = 1,2
10 V/m
d = 1,2
80 MHz – 2,7
Power frequency
d = 2,3
GHz
Where P is the maximum output power rating of the transmitter in watts (W)
80 % AM at 1
according to the transmitter manufacturer and d is the recommended
kHz
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
WAND is intended for use in the electromagnetic environment (for home healthcare) specified below. The customer or the user
range. b Interference may occur in the vicinity of equipment marked with
the following symbol:
Immunity test IEC 60601 Compliance Electromagnetic environment – guidance (for home healthcare environment)
Radiated RF
IEC 61000-4-3
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 affected by absorption and reflection
electromagnetic emissions
–
Electromagnetic environment – guidance
(for home healthcare environment)
Floors should be wood, concrete or ceramic tile. If floors are
Manufacturer's declaration-electromagnetic emissions
covered with synthetic material, the relative humidity
should be at least 30%
The non-contact forehead thermometer power frequency
Electromagnetic environment – guidance (for home healthcare environment)
magnetic fields should be at levels characteristic of a typical
location in a typical home healthcare environment.
WAND is suitable for use in all establishments, including domestic establishments and those direct
Manufacturer's declaration – electromagnetic immunity
Electromagnetic environment – guidance
(for home healthcare environment)
Immunity test IEC 60601 test level Compliance level
Electrostatic Contact: ±8 kV Contact: ±8 kV Floors should be wood, concrete or ceramic tile. If floors are
IEC 61000-4-2
80MHz to 800 MHz
(50, 60 Hz)
800MHz to 2,7 GHz
50 Hz or 60 Hz 50 Hz and 60 Hz
61000-4-8
Manufacturer's declaration – electromagnetic immunity
80 MHz – 2,7 80 MHz – 2,7
GHz GHz
80 % AM at 80 % AM at 1
Power/Memory
Battery recycling
Indicates this device is subject
to the Waste Electrical and
Electronic Equipment Directive
in the European Union. To protect
the environment, dispose of
useless device at appropriate
collection sites according to
national or local regulations.
Electromagnetic environment – guidance
(for home healthcare environment)
Electromagnetic environment – guidance
WAND power frequency magnetic fields should be at levels
Home healthcare
Recommended separation distance:
Where P
Field strengths from fixed RF transmitters, as determined by an electromagnetic site
Interference may occur in the vicinity of equipment marked with