Instructions for Use RAUMEDIC
MPR2 logO
Manufacturer: zwo-400EN
RAUMEDIC AG, Hermann-Staudinger-Strasse 2, 95233 Helmbrechts, Germany Rev. 9 2020-09-22
Page 87 of 99
8 Safety and measurement related checks
8.1 General aspects
In addition, the national regulations and requirements derived from them must always be
observed.
The following checks must be carried out at least once a year for the safe and
continuousoperation of the MPR2 logO:
- Electrical safety test: leakage current of the device including the main power adapter and of
the main power adapter separately
- Check of the accuracy of the pressure and temperature measurement
- Check of the accuracy of the analog outputs
The Medical Devices Operator Ordinance (German abbreviation: MPBetreibV) named below is a
German regulation and is therefore not binding for other countries.
The Medical Devices Operator Ordinance (MPBetreibV) is the source for the operator’s
obligation to have a measurement check performed for medical devices that determine body
temperatures (medical electronic thermometers) every two years. The MPR2 logO is a device
with an electric temperature measurement function.
As the manufacturer, we provide you with the option of having the necessary checks carried
out by RAUMEDIC.
These checks may only be carried out by appropriately qualified specialist personnel (suitable
training, knowledge and practical experience gained “on-the-job”).
8.2 Safety-related check
The operator must have safety checks performed for medical devices in accordance with
generally recognised technical regulations. He must allow such time limits for the safety
checks that corresponding defects that are to be expected on the basis of experience can be
detected in good time. The safety checks include measurement functions. The manufacturer
recommends a period of 12 months.
After each service action, a safety check must likewise be carried out.
8.3 Measurement-related check-up
The measurement check is to be carried out according to the legal requirements.
The measurement check must also be carried out if there are signs of non-adherence to the
specified thresholds (see 11.1 Technical data
) and if the metrological properties may have been
affected by interventions or in some other way.
The “Guideline On Metrological Check-ups of Medical Products with Measuring Functions”, part 1,
published by the German Federal Physical Technical Institute is recommended for orientation on scope
and procedure (status: December 2016).
This document is for information only
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