RAUMED NeuroSmart Instruction Manual
Manufacturer: RAUMEDIC AG, Hermann-Staudinger-Strasse 2, 95233 Helmbrechts, Germany
zwo-541EN Rev 3 / 2022-05-03
Page 54 of 61
7 Inspections, safety and measurement checks
In principle, national regulations and the resulting requirements must be observed.
For safe and continuous operation of the NeuroSmart device, the following tests must be carried
out at least once a year:
- Electrical safety test (leakage currents) of the device with adapter and separate adapter
- Test of the accuracy of pressure and temperature channels
- Test of the accuracy of analogue outputs
The Medical Devices Operator Ordinance (Medizinprodukte-Betreiberverordnung; MPBetreibV) is
a German regulation that is non-binding for other countries.
Under the Medical Devices Operator Ordinance (MPBetreibV), the operator has an obligation to
determine body temperatures for medical devices (medical electronic thermometer) and carry out
a measurement check at least every two years. The NeuroSmart is a device with an electric tem-
perature measurement function.
If the NeuroSmart data is operated in conjunction with the Reader TDT1 readP and a NEU-
ROVENT-P-tel, this is subject to the legal requirement for a safety check in accordance with Section
11 of the Medical Devices Operator Ordinance (MPBetreibV) in conjunction with Annex 1.3.
As the manufacturer, we provide you with the option of having the necessary checks/tests carried
out by RAUMEDIC.
The aforementioned checks/tests may only be carried out by appropriately qualified specialist per-
sonnel (suitable training, knowledge, and practical experience gained “on-the-job”).
7.1 Safety check (SC)
The operator is obliged to have safety checks for medical devices conducted based on generally
accepted technical regulations. The operator must set deadlines for the safety checks that allow
for the timely identification of relevant deficiencies, which can be expected based on regular expe-
rience. Safety checks include measurement functions. The manufacturer recommends a period of
12 months for carrying this check out.
After each service action, a safety check must likewise be carried out.
7.2 Measurement check (MC)
For carrying out measurement checks, the manufacturer recommends a period of 12 months.
The measurement check must moreover be carried out if there are signs of non-compliance with
the specified limit values (see Section 6.1) and if the metrological properties may have been af-
fected by interventions or in some other way.
The “Manual for measurement checks on medical devices with a measurement function” (LMKM), Part
1 produced by the German National Metrology Institute (Revision: December 2016) is recommended as
guidance for scope and procedure.
This document is for information only
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