Instructions for Use MPR1 DATALOGGER
Manufacturer:
RAUMEDIC AG, Hermann-Staudinger-Strasse 2, 95233 Helmbrechts, Germany
Page 84 of 98
8 Inspections, Safety and Measurement Checks
8.1 General
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 continuous
operation of the Datalogger MPR1:
-
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) at least every two years. The Datalogger MPR1
is a device with an electric temperature measurement function.
If the Datalogger MPR1 is operated in combination with the Reader TDT1 readP and a
NEUROVENT-P-tel, it is subject to legal requirement for safety check according to Medical
Devices Operator Ordinance (MPBetreibV) §11 in conjunction with Annex 1 point 3.
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 check (SC)
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 check (MC)
The metrological control shall be performed in accordance with the legal requirements.
The measurement check must also be carried out if there are signs of non-adherence to the
) and if the metrological properties may have been
affected by interventions or in some other way.
The "Manual for instrumentation checks on medical products with a measurement function" (LMKM), Part
1 produced by the German National Metrology Institute (Revision: December 2016) is recommended for
orientation.
This
document
is
for
information
only
