Gendex ORTHORALIX 8500 - Compliance with Applicable Standards

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Operator’s Manual 032-0176-EN Rev. 4
Compliance with
Applicable Standards
Class and Type of Certied 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 certied 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.
Modications 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.
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