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1 Important information regarding safe use
55000-00011_002_01 – 1756789 – 2017-09-06
CE mark:
This device is a Class I medical device as defined by the European Medical
Device Directive (MDD).
UL mark
UL marking: device has been tested by Underwriter Laboratories Inc. for the USA and
(only NRTL region)
Canada with regard to electric shock and fire hazard as well as mechanical hazards.
1.8.2
Standards and Directives
The device complies with the safety requirements of the following standards and
directives:
MDD
• COUNCIL DIRECTIVE 93/42/EEC of 14 June 1993 concerning medical devices
RoHS
• DIRECTIVE 2011/65/EU OF THE EUROPEAN PARLIAMENT AND COUNCIL dated 8
June 2011 to restrict the use of specific harmful substances in electrical and
electronic devices
– EN 50581 Technical documentation for the assessment of electrical and
electronic products with respect to the restriction of hazardous substances
Electrical safety
• EN 60601-1 Medical electrical equipment — Part 1: General requirements for
basic safety and essential performance
• EN 60601-1-2 (IEC 60601-1-2) - Medical electrical equipment - Electromagnetic
compatibility
1.8.3
Internationally applied standards
• UL 60601-1
• ANSI / AMI ES 60601-1
• CAN/ CSA-C22.2 No. 60601-1
• IEC 60601-1
• IEC 60601-1-2
1.8.4
Intended use
Intended use
The device is intended for use in a patient environment in hospitals or medical
practices to illuminate a part of the patient with high light intensity for examination
or surgical purposes.
The working range lies at a distance between 70 cm to 150 cm to the wound area. The
device is suitable for continuous operation.
Application does not involve the patient; unintentional contact is possible.
Each use exceeding the aforementioned conditions is not considered to be intended
use. Only the user or operator will be liable for any loss or damage arising as a result.
Cleaning
As part of daily clinical routine, the equipment is cleaned several times. This is most
often done by turning around housing parts for wiping and drying that are usually
facing down.
Single light
Definition: small surgical light
A small surgical light is a single lamp for use in operating theatres to support
diagnoses or treatments that do not pose a risk to the patient due to interruptions by
lighting failure (IEC 60601-2-41).