Safety Instructions; General Instructions - Primedic DefiMonitor XD Series Operating Manual

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DefiMonitor XD

Safety Instructions

General Instructions

The PRIMEDIC™ DefiMonitor XD defibrillator and its standard as well as optional ac-
cessories fulfil all safety norms currently valid and meet all the criteria of the guide-
lines for medical devices.
The device and its accessories are safe if they are used for the purpose intended as
described and instructed in this manual.
Nevertheless, the device and its accessories and their incorrect use can be dangerous
for you, the patient or any other person!
Therefore, we absolutely insist that before using it for the first time, all the persons
who need to or want to use this device, must
– be authorised through training by briefing them about the medical background
of defibrillation and the indications and contraindications!
read this operating manual and moreover, follow the safety instructions
–
and the warnings given in it!
– Doctors
PRIMEDIC™ DefiMonitor XD
only. Reading the operating manual is not a substitute for training.
PRIMEDIC™ DefiMonitor XD
explosions.
In case of improper use or use for a purpose other than for the intended purpose,
the user (you), the patient or any other person is exposed to the
– risk of an electric shock through the high voltage generated by the device,
– risk of getting affected by active implants
– risk of burns if the electrodes are placed incorrectly
Moreover, the device can be damaged or destroyed due to improper use!
Follow the rules and instructions listed in the appendix while using PRIMEDIC™ De-
fiMonitor XD!
During transportation of the DefiMonitor XD in a vehicle the Paddles have to be
stored on the paddle rest, and the device must be placed on the wall mount rack.
For Europe, the following applies:
The device fulfils the provisions of the Medical Devices Act (MPG). In case of other
countries of the European Union, the national regulations covering the operation of
medical devices will apply.
The following regulations that apply in the Federal Republic of Germany additionally:
– The device fulfils the provisions of the Medical Devices Act (MPG – Medizinpro-
duktegesetz) and is subject to the Medical Devices Operator Ordinance (MPBe-
treibV – Medizinprodukte-Betreiberverordnung).
– According to the Medical Devices Operator Ordinance (MPBetreibV), the device is
subject to regular checks described in the appendix.
– According to the Medical Devices Operator Ordinance (MPBetreibV), a medical
device book must be maintained for the device. Regular checks of the device must
be recorded in it.
must be operated by trained and authorised persons
not
must be used in areas where there is a danger of
Operating Manual
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