18
1
All specifications are subject to change without notice.
2
The CE mark on this product (230V, 240V version) indicates it has been tested to and conforms
to the provisions noted within the 93/42/EEC Medical Device Directive.
5.0 Technical Data
1
Type of Data
Classifications
Type of Protection Against Electric Shock
Class I
FDA Classification
FDA Class I, Examination Light
CISPR II Classification
Class A
Allowable Earth Leakage Current
Does not exceed 500
μ
a
Allowable Touch Leakage Current
Does not exceed 100
μ
a
Reliability of Earth Protection
Does not exceed 0.1 ohm
Mode of Operation
Continuous
Protection Against Explosion
Hazards
Not to be used in the presence of flammable anesthetics
Protection Against Hazardous Parts and
Ingress of Liquids
IPXO. Not protected against the ingress of fluids.
Degree of Mobility
Ceiling and wall mount versions: permanently installed.
Floor stand version: mobile.
Approvals
IEC 60601
-
1, IEC60601
-
2
-
41, IEC 60601
-
1
-
2
EU Conformance
2
CE Classification
Class I
WARNING:
Use of this equipment adjacent to or stacked with other equipment
should be avoided because it could result in improper operation. If such use is neces-
sary, this equipment and the other equipment should be observed to verify that they
are operating normally.
WARNING:
Use of accessories, transducers and cables other than those specified or
provided by the manufacturer of this equipment could result in increased electromag-
netic emissions or decreased electromagnetic immunity of this equipment and result
in improper operation.
WARNING:
Portable RF communications equipment (including peripherals such as
antenna cables and external antennas) should be used no closer than 30 cm (12 inch-
es) to any part of the AIM HI
LED
Fixture, including cables specified by the manu-
facturer. Otherwise, degradation of the performance of this equipment could result.
”
WARNING:
This equipment/system is intended for use by healthcare professionals
only. This equipment/ system may cause radio interference or may disrupt the opera-
tion of nearby equipment. It may be necessary to take mitigation measures, such as
reorienting or relocating the equipment or shielding the location.