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OSMOMAT 050 User Guide
Version 1.1 (2011-10-12)
8 Maintenance of the OSMOMAT 050
8.1 Requirements of the Medical Devices Operator Ordinance
The regulatory scope of Germany’s Medical Devices Operator Ordinance includes the maintenance
and servicing of medical devices. Sections
2 (Special Regulations for Active Medical Devices)
and
3 (Medical Devices with Measurement Functions)
regulate the safety and measurement
checks to be performed on medical devices.
These checks are mandatory for medical devices listed in
Annexes 1 and 2 of the Medical Devices
Operator Ordinance
.
8.2 Safety Checks (§ 6 of Medical Devices Operator Ordinance)
The OSMOMAT 050 is not listed in Annex 1 of the Medical Devices Operator Ordinance. Public au-
thorities do not require the unit to undergo safety checks.
Safety checks should be conducted by the on-site safety coordinator in accordance
with relevant accident prevention guidelines.
8.3 Measurement Checks (§ 11 of Medical Devices Operator
Ordinance
The Osmomat 050 is not listed in Annex 2 of the Medical Devices Operator Ordinance. No measure-
ment checks are stipulated by the Ordinance.
Nonetheless, the user should perform the following checks:
•
Checking and filling the solvent bottle
•
Emptying the waste bottle
•
Calibrating the device
The calibration frequency should comply with local quality assurance guidelines.
Summary of Contents for OSMOMAT 050
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