Compliance With Applicable Standards - Gendex ORTHORALIX 8500 Operator's Manual

Compliance with
Applicable Standards
Class and Type of Certified equipment: ORTHORALIX 8500 belongs to the Class I Type B equipment
per IEC 60601.1 – 1990 / A2 - 1995 and Class IIb per European MDD 93/42/EEC.
The ORTHORALIX 8500 complies with the following standards:
General (electrical/mechanical) safety:
• UL 60601-1 File Number: E185414
• CAN/CSA C22.2 No. 601.1 - M90
• IEC60601-2-32
• Electromagnetic Interference: IEC 60601-1-2:
• Radiation protection: IEC 60601-1-3 Radiation protection/X-Ray Equipment
• Lasers: IEC 60825-1 (2001)
The ORTHORALIX 8500 Tubehead complies with the following standards:
• IEC60601-2-7
• IEC60601-2-28
The certified components of the ORTHORALIX 8500 system comply with Radiation Performance
Standards 21 CFR, Subchapter J, at time of manufacture.
The equipment must only be installed and operated in accordance with the safety
procedures and operating instructions given in this Operator's Manual and in the
Installation/ Maintenance Manual for the purposes and applications for which it was
designed.
Modifications and/or additions to the equipment may only be carried out by Gendex or
by third parties expressly authorized by Gendex to do so. Such changes must comply with
legal requirements as well as with the generally accepted technical rules.
It is the responsibility of the user to ensure that existing legal regulations regarding
installation of the equipment with respect to the building are observed.
Operator's Manual
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032-0176-EN Rev. 4