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Technical Data for OASYS Central Axis and Spring Arms
Classification
IEC 60601-1, UL 60601-1, CAN/CSA-C22.2 No. 601.1-M90
Device Protection – Class I
Protection Type – enclosed design ordinary appliance (enclosed unit with no protection against ingress of
water)
Applicable Standards
UL 60601-1:2003
Approval for Standard Version
The pendant system is tested under UL 60601-1:2003
EC Conformity
The central axis complies with the provisions of directive 93/42/EEC (medical devices directives) and directive
89/336/EEC (EMC directive)
The Pendant System is Only Approved for the Connection of the Following Devices
• The central axis is only approved for the connection of medical end devices such as monitors, operating and
examination lamps as well as devices for diagnostics, treatment or surgical interventions bearing the CE mark.
• When these devices are attached to the central axis, the distributor must submit a declaration as specified by
article 12 of directive 93/42/EEC (Medical Devices Directive).
• When other devices are attached, a new conformity assessment must be drawn up.
Combination with Other Medical Devices
• The central axis is equipped with end devices (e.g. monitors) from other manufacturers.
• Please refer to the instructions supplied by the respective manufacturer for the necessary information on
installing the end device.
