Safety Check / Metrological Check; Safety Checks - Zimmer Cryo 6 Instructions For Use Manual

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Safety checks

17
Metrological control
In Germany, no safety checks according to section 6 of the MPBetreibV (Medical Device
Operator Ordinance) are required for the device Cryo 6. The device is not listed in
attachment 1 of the ordinance.
A metrological control (MTK) according to section 11 of the MPBetreibV (Medical device
operator ordinance) is also not required for the device Cryo 6. The device is not listed in
attachment 2 of the ordinance.
Note:
These requirements apply to the operation of the device in Germany. Please
consider divergent national regulations in your country.
Page 34

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