Lightmed LightLink-CXL, Руководство по обслуживанию

Страница: 12 / 99

LightLink-CXL – Service Manual Rev. No. : 01 Page 11 of 98
USA 21 CFR 1040.20 (1979)

Electrical standards
IEC60601-1 (2005)
IEC60601-1-2 (2007)
USA UL 60601-1
JIS T1001 (1992) and T1002 (1992)

Others
MDD 93/42/EEC (as amended by 2007/47/EC)
ISO14971 (2007)
IEC62471(2007)
2.2 Warnings and Precautions
The following warnings and precautions apply to the LightLink-CXL System and should
be observed by all users at all time:

DO NOT try to service or repair the system other than what is included in this
manual. Service should only be performed by an authorized and trained agent of
the manufacturer.

ALWAYS set the correct spot size and/or use the most appropriate one for the
power setting and type of procedure that is to be performed.

All modifications or repairs must be performed by qualified professionals
approved by LightMed Corporation.

For safety reasons, unauthorized persons should never open the equipment,
therefore avoiding dangerous situations

Always use clinical protocols that are scientifically recognized nationally or
internationally.

The equipment’s correct functioning depends on the installation, in addition to a
suitable location selected for its operation. The use of a grounded outlet is
specifically recommended, or the coupling of the pin-earth grounding in the
physical location.

The use of non-specified controls, adjustments or procedures may result in
ultraviolet radiation exposure, dangerous to the user. Read these guidelines,
and always note the special particularities used in the markings of the
equipment.

DO NOT operate the equipment in the presence of flammable gases, special
attention should be given to avoid using the equipment in places where there
are flammable oxidizable gases or anesthetics