Instructions for Use RAUMEDIC
MPR2 logO
Manufacturer:
RAUMEDIC AG, Hermann-Staudinger-Strasse 2, 95233 Helmbrechts, Germany
Page 5 of 99
Instructions for Use for RAUMEDIC
®
MPR2 logO
Battery-operated patient monitoring unit for the functions of partial oxygen pressure, invasive pressure and
temperature
0 General notes
The MPR2 logO has received the mark
0123
in compliance with the European Directive 93/42/EEC, and
meets the fundamental requirements of this directive rendered in Annex I. 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. These
instructions for use can be supplemented by a Quick Guide, but they cannot be replaced by the said.
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
