10 Servicing of the OSMOMAT auto
10 Servicing of the OSMOMAT auto
10.1 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 devices listed in
Annexes 1 and 2 of the Medical Devices Operator
Ordinance
.
10.2 Safety Checks (§ 6 of Medical Devices Operator Ordinance)
The OSMOMAT auto is not listed in Annex 1 of the Medical Devices Operator Ordinance. Public
authorities 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.
10.3 Measurement Checks (§ 11 of Medical Devices Operator
Ordinance)
The OSMOMAT auto is not listed in Annex 2 of the Medical Devices Operator Ordinance. No
measurement checks are stipulated by the Ordinance.
Nonetheless, the user should perform the following checks:
•
Calibration of the unit with a standardized osmometry calibration solution
•
Comparative measurements with OSMOREF 290 or aqueous solutions of known
osmolality
•
Logging of measurement readings and any evaluation results
The frequency of such checks should comply with local quality assurance guidelines.
10.4 Internal
Quality
Control of the OSMOMAT auto
A microcontroller monitors the unit’s functions based on the program flow. The failure of individual
functional groups in the unit results in a malfunction that either outputs an error message or shuts
down the unit. Standardized calibration and reference solutions and an adjustment tool are used to
check the internal quality control mechanism.
Servicing of the OSMOMAT auto
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