7200790 Service Manual for the HELION
®
XENION
®
Surgical Lighting System GB
94
16 Technical Data (cont.)
Noise level acc. to EN 793: 1998
Sound energy levels > 30 db(A) (EN ISO 3744) are not exceeded
Classification acc. to EC Medical Device Directive dated 14 June 1993: 93/42/EEC:
Protection class: I
Protection level: Type B
Protection type: covered design
Standard device (closed device without protection from ingress of water)
The lighting system is not designed for operation in potentially explosive atmospheres.
The lighting system is suitable for continuous operation.
Applicable regulations
DIN EN 60601-1 (VDE 0750 part 1)
DIN EN 60601-1:1998 + A1:1991 + A2:1995
DIN EN 793: 1998 (VDE 0750 part 211)
UL60601-1 1st: "CSA C22.2 No. 601.1"
Approvals for standard version
The product has been tested and certified by the Testing and Certification Institute (EU code no. 0123).
The marks licensing certificate entitles the device to bear the CE mark showing the number of the notified body 0123.
EC Conformity
The HELION
®
and XENION
®
lighting systems comply with the provisions of the Directive 93/42/EEC (Medical Device
Directive).
If other lamps are connected to the TRUMPF KREUZER lighting sytem a new conformity assessment must be issued.
Installation of the lamps on a lighting system not specified above must be clarified with TRUMPF KREUZER. A new conformity
assessment must be issued.
Combination with other medical devices
The ceiling-mounted support system is provided with equipment (e.g. monitor, etc) from other manufacturers. Please refer to
the operating instructions of these manufacturers for the information necessary for operation.
CE 0123
TÜV Product Service, Munich, Germany, EC code number: 0123