General Safety Instructions - Primedic HeartSave AED Operating Instructions Manual

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Safety information
The PRIMEDIC™ HeartSave AED / AED-M may only be used by trained and
Note
authorised personnel. Reading the operating instructions does not replace
training. The PRIMEDIC™ HeartSave AED / AED-M is not licensed for use in
explosive areas.
Applicable for Europe:
The device complies with the Medical Device Directive (MDD).
The respective national guidelines for operating medical products are applicable.
For Germany, the following is also applicable:
The device is subject to the German Medical Products Act (MPG).
Thus the German Medical Products User Regulations (MPBetreibV) also apply.
The German Medical Products User Regulations is not applicable for medical products
which serve neither commercial nor business purposes and where no employees are
working in the hazardous area around them.

3.2 General safety instructions:

HeartSave AED / AED-M, 21212 / GB / E02
DANGER
Not using the device as intended or using it improperly,
exposes you (the user), the patient or third parties to danger
of an electric shock from the high voltage generated by
the device,
of influencing active implants,
of burns from incorrectly applied electrodes.
Apart from that, the device can be damaged or destroyed
through improper use.
DANGER
Observe the information and rules in the appendix on using
the PRIMEDIC™ HeartSave!
DANGER
Do not use the device in the vicinity of flammable materials
(e.g. cleaning solvent or similar) or in an atmosphere enriched
with oxygen or with flammable gases / vapours!
7

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