1-6 CASE Revision C
2060290-201
Safety Information
requirements of this equipment may lead to a reduced level of safety
of the resulting system. Considerations relating to the choice shall
include:
use of the accessory in the patient vicinity and
evidence that the safety certification of the accessory has been
performed in accordance to the appropriate IEC 60601-1 and/or
IEC 60601-1-1 harmonized national standard.
Definition
The terms Danger, Warning, and Caution are used throughout this
manual to point out hazards and to designate a degree or level of
seriousness. Familiarize yourself with their definitions and significance.
Hazard is defined as a source of potential injury to a person.
The safety statements presented in this chapter refer to the equipment
in general.
The order in which safety statements are presented in no way implies
order of importance.
Danger — indicates an imminent hazard which, if not avoided, will
result in death or serious injury.
Warning — indicates a potential hazard or unsafe practice which, if not
avoided, could result in death or serious injury.
Caution — indicates a potential hazard or unsafe practice which, if not
avoided, may result in minor personal injury or product/property
damage.
Danger
Explosion Hazard — The device is not designed for use in
areas of medical locations where an explosion hazard
may occur. An explosion hazard may result from the use
of flammable anesthetics, skin cleansing agents and
disinfectants. Furthermore, the device is suitable for
application in an oxygen-enriched atmosphere only with
certain restrictions. The atmosphere is considered to be
oxygen-enriched when the room air contains more than
25 % of oxygen or nitrous oxide.
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