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CardioSoft - Jaken Medical...

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Introduction: Safety Information<br />

Definition<br />

The terms Danger, Warning, and Caution are used throughout this<br />

manual to point out hazards and to designate a degree or level of<br />

seriousness. Familiarize yourself with their definitions and significance.<br />

Hazard is defined as a source of potential injury to a person.<br />

The safety statements presented in this chapter refer to the product in<br />

general.<br />

The order in which safety statements are presented in no way implies<br />

order of importance.<br />

Danger — indicates an imminent hazard which, if not avoided, will<br />

result in death or serious injury.<br />

Warning — indicates a potential hazard or unsafe practice which, if not<br />

avoided, could result in death or serious injury.<br />

Caution — indicates a potential hazard or unsafe practice which, if not<br />

avoided, may result in minor personal injury or product/property<br />

damage.<br />

Danger<br />

Explosion Hazard — The acquisition module is not<br />

designed for use in areas of medical locations where an<br />

explosion hazard may occur. An explosion hazard may<br />

result from the use of flammable anesthetics, skin<br />

cleansing agents and disinfectants. Furthermore, the<br />

device is suitable for application in an oxygen-enriched<br />

atmosphere only with certain restrictions. The<br />

atmosphere is considered to be oxygen-enriched when the<br />

room air contains more than 25% of oxygen or nitrous<br />

oxide.<br />

1-8 <strong>CardioSoft</strong> Revision A<br />

2023324-053

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