Observe the information and rules in the appendix on using the
PRIMEDIC™ DefiMonitor XD.
When carrying the DefiMonitor XD in a vehicle, the paddles must be
secured in the attachment provided and the device must be secured stored
in a wall bracket.
Applicable for Europe:
• The device complies with the Medical Device Directive (MDD).
Additionally, following apply to Federal Republic of Germany:
• The device complies with the Medical Devices Law (MPG) and is subject to the
Ordinance on the Operation and Use of Medical Devices (MPBetreibV).
• According to the Ordinance on the Operation and Use of Medical Devices
(MPBetreibV), the device is to be subjected to the regular checks explained in the
appendix.
• According to the Ordinance on the Operation and Use of Medical Devices
(MPBetreibV), a medical devices log needs to be kept for the device. Regular
checks of the device are to be documented in it.
For the other states in the European Community, national regulations for operating medical
devices apply.
3.2 General safety instructions
The device may not be used in the vicinity of flammable materials
(e.g. cleaning solvents or similar) or in an atmosphere enriched with
oxygen or flammable gases/vapours.
Monitor the use of the device at all times.
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