GENDEX 765DC Benutzerhandbuch Seite 5

COMPLIANCE WITH APPLICABLE STANDARDS
The 765DC complies with the following standards:
34SL
MEDICAL EQUIPMENT WITH RESPECT TO ELECTRICAL SHOCK, FIRE AND
MECHANICAL HAZARDS ONLY IN ACCORDANCE WITH UL60601-1, IEC60601-1,
CAN/CSA C22.2 NO,601.1-M90, AND TO THE FOLLOWING PARTICULAR STANDARDS,
IEC60601-2-32, IEC60601-2-7 IEC60601-2-28, IEC60601-1-2.
Radiation protection IEC60601-1-3 Radiation protection/x-ray equipment.
The certified components of the 765DC system comply with Radiation Performance
Standards 21 CFR, Subchapter J, at the time of manufacture.
The equipment must only be installed, and operated in accordance
with the safety procedures and operating instructions given in this User
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.
IMPORTANT! ...... X-RAY PROTECTION
X-ray equipment may cause injury if used improperly.
The instructions contained in this manual must be read and followed when
operating the 765DC. Your Gendex dealer will assist you in placing the 765DC in
operation.
The 765DC intraoral x-ray system provides a high degree of protection from
unnecessary X-radiation. However, no practical design can provide complete
protection, nor prevent operators from exposing themselves or others to
unnecessary radiation.
General (electrical/mechanical) safety:
UL60601-1 File Number: E185414
Printed on: 29 Mär 2012, 05:33:23 pm; Printed by: UWE.ZELLER
765DC
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