Safety and Regulatory Information
AT000115-02 7
Laser Safety Instructions
The Point of Care 120/140 CR Reader is classified as a CLASS 1 Laser product.
• During normal operation, always keep the unit enclosed in its protective cover.
• Do not attempt to remove the cover. Only a qualified technician may remove the cover to service this product.
COMPLIES WITH 21 CFR 1040.10 AND 1040.11 EXCEPT FOR DEVIATIONS PURSUANT TO LASER NOTICE
NO. 50, DATED JULY 26, 2001.
CLASS 1 LASER PRODUCT, and IEC/EN 60825-1.
CLASS 1 EQUIPMENT.
INTENDED FOR CONTINUOUS OPERATION.
PRODUCT IS PROVIDED WITH ORDINARY PROTECTION AGAINST THE HARMFUL INGRESS OF WATER.
NOT SUITABLE FOR USE IN THE PRESENCE OF A FLAMMABLE ANESTHETICS MIXTURE WITH AIR OR WITH
OXYGEN OR WITH NITROUS OXIDE.
The use of accessory equipment not complying with the equivalent safety requirements of this equipment may lead
to a reduced level of safety of the resulting system. Consideration relating to the choice shall include:
• Use of the accessory in the patient vicinity.
• Evidence that the safety certification of the accessory has been performed in accordance with IEC 60601-1 or
the system to IEC 60601-1-1 or local equivalent.
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