WARNING:
The warning statements in this manual identify conditions or practices that
could lead to illness, injury, or death.
CAUTION:
The caution statements in this manual identify conditions or practices that
could result in damage to the equipment or other property, or loss of data.
Instructions for use (IFU).
Meets essential requirements of European Medical Device Directive 93/42/EEC.
0598
1. Symbols
Documentation Symbols
Shipping, Storing, and Environment Symbols
Temperature Limits:
-13°F/-25°C - 131°F/55°C
Keep dry
Electronic Waste:
Dispose of this device in accordance with local or national
regulations
Fragile
Humidity Limitation:
Up to 85%
Protected against solid foreign objects of 12.5mm diameter or greater. Protected against
vertically falling water drops when the device is titled up to 15°.
IP22
-13° F
-25° C
131° F
55° C
15%
85%
Miscellaneous Symbols
Manufacturer
Product identifier
European authorized representative
Global trade identification number
Serial number
REF
SN
EC REP
GTIN
4
17
Guidance and Manufacturer's Declaration Electromagnetic emissions
The 429 IR Thermometer is intended for use in the electromagnetic environment specified below. The
customer or the user of the 429 IR thermometer must make sure it is used in such an environment.
a) The equipment is suitable for use in Home Health Environments and Professional Health Care Environments limited
to patient rooms and respiratory treatment facilities in hospitals or clinics. The more restrictive acceptance limits of
Group 1 Class B (CISPR 11) have been considered and applied. The equipment is suitable for use in the mentioned
environments when directly connected to the Public Mains Network.
b) The test is not applicable in this environment unless the ME EQUIPMENT and ME SYSTEM used will be connected
to the PUBLIC MAINS NETWORK and the power input is otherwise within the scope of the Basic EMC standard.
Guidance and manufacturer’s declaration - Electromagnetic immunity - Enclosure port
a) The equipment is suitable for use in Home Health Environments and Professional Health Care Environments limited
to patient rooms and respiratory treatment facilities in hospital or clinics. The more restrictive IMMUNITY acceptance
limits have been considered and applied.
b) Before modulation is applied.
c) This test level assumes a minimum distance of at least 15 cm between the ME EQUIPMENT or ME SYSTEM and
source of power frequency magnetic fields.
Professional healthcare facility
environment a)
Home Healthcare environment a)
Guidance and manufacturer’s declaration - Electromagnetic emissions
Phenomenon
Phenomenon
Immunity test levels
Basic EMC standard
or test method
Conducted and radiated RF EMISSIONS
Harmonic distortion
Voltage fluctuations and flickering
Not applicable
Not applicable
CISPR 11 Group 1 Class B
a)
ELECTROSTATIC
DISCHARGE
IEC 61000-4-3
IEC 61000-4-3
IEC 61000-4-8
30 A/m c)
50 Hz or 60 Hz
a)
10 V/m b) 80MHz - 2.7
GHz 80% AM at 1kHz
IEC 61000-4-2
± 8 kV contact
± 2 kV, ±4 kV ±, ±8 kV, ±15 kV air
Professional healthcare
facility environment
HOME HEALTHCARE
ENVIRONMENT
Radiated RF EM fields
Proximity fields
from RF wireless
communications
equipment
RATED power frequency
magnetic fields
COMPLIANT NOTE: Further information about
distances to be maintained between portable and
mobile RF communications equipment (transmitters)
and the 429 IR can be requested from ADC using the
contact information provided in this manual. However,
it is advisable to keep the electromechanical aerosol
equipment at an adequate distance of, at least 0.5 m
from mobile phones or other RF communications
transmitters to minimize possible interference.
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