RAUMEDIC MPR1, Инструкция по эксплуатации

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Instructions for Use MPR1 DATALOGGER
Manufacturer: zwo-399EN
RAUMEDIC AG, Hermann-Staudinger-Strasse 2, 95233 Helmbrechts, Germany Rev. 9, 2020-10-16
Page 5 of 98
Instructions for Use of RAUMEDIC ® MPR1 DATALOGGER
Battery-operated patient monitoring unit for the functions of invasive
pressure and temperature
0 General notes
The MPR1 DATALOGGER is labelled
0123
and fulfils the basic requirements of the following directives:
• MDD (Directive 93/42/EEC), appendix I
•
AIMDD (Directive 90/385/EEC), appendix I.
Use for cabled invasive pressure measurement and temperature measurement is covered by the CE
approval in accordance with MDD.
Telemetric pressure measurement with a pressure measurement implant is covered by the approval in
accordance with AIMDD.
All manufacturing processes have been monitored by a QM system in keeping with ISO 13485.
The appliance is shielded in compliance with standard IEC 60601-1-2 and meets the limiting values in
compliance with European standard EN 55011, Group 1, Class A.
The CE mark covers only those accessory parts listed in the delivery overview. These instructions for use
shall be considered part of the appliance, and shall have to be kept available in the vicinity of the appliance.
The exact observation of the instructions for use shall be the pre-requisite for the intended use and correct
handling of the appliance as well as the safety of patient and operator dependent thereupon.
Patient safety, adherence to the measuring accuracy indicated and the highest possible immunity to failure
shall be ensured only if original parts of the manufacturer (such as basic appliance, cables, sensors) are
used.
Only those accessories shall be used which are mentioned in these instructions for use, and which have
been tested along with the appliance. If foreign accessories are used nonetheless, the safe operation and
safe function can no longer be guaranteed. Warranty claims shall not be accepted in case of damage
caused by using foreign accessories.
The manufacturer considers himself responsible for the appliances with respect to their safety, reliability
and function only, if:
• the appliance is used in conformity with these instructions for use.
• the installation, the extensions, the re-adjustments, the modifications and the repairs have been carried
out by the manufacturer himself or persons authorised by the said.
This
document
is
for
information
only