Instructions for Use RAUMEDIC
MPR2 logO
Manufacturer:
RAUMEDIC AG, Hermann-Staudinger-Strasse 2, 95233 Helmbrechts, Germany
Page 8 of 99
2 Description of the device
2.1 Intended purpose
2.1.1 Description
The MPR2 is used to monitor the oxygen partial pressure, to monitor up to two invasively measured
physiological pressures, and to monitor of up to two temperatures of the patient (with alarm function).
2.1.2 Intended use
The MPR2 is a diagnostic unit with physiological threshold value monitoring and display of the following
physiological parameters: invasive pressure (ICP, IBP, two channels), oxygen partial pressure (pO2, one
channel) and temperature (T, two channels). Invasive pressure measurement, oxygen partial pressure
measurement and temperature measurement are significant performance characteristics of the unit. These
parameters are determined by using RAUMEDIC catheters for single-channel ICP measurement or with
RAUMEDIC multi-parameter catheters for combined measurement of ICP and temperature. In addition,
external transducers may also be used for the invasive pressure measurement. Optionally up to two
pressure signals can be passed on through the two analogue outputs to a bed-side monitoring device with
threshold monitoring.
2.1.3 Operational environment
The MPR2 is intended for use in clinical environments to be operated by specialized medical staff. The unit
is used either stationary or mobile during transport in the hospital. Doctors, intensive care nurses and
medical technicians shall use the unit. The unit is not intended for use outside of the hospitals, such as in
helicopters or in ambulances. The MPR2 is not intended for use in domestic settings.
2.2 Indications
2.2.1 Conditions
The use of the MPR2 is indicated, when the doctor considers it necessary to measure and monitor several
physiological parameters, such as invasive pressure, oxygen partial pressure and temperature.
2.2.2 Body parts or types of tissue interacting with the unit
The MPR2 has no body or tissue contact with the patient. Signals are received from sensors.
2.2.3 Frequency of use
The use of the MPR2 is indicated when the attending physician prescribes the application. The MPR2 has
been designed for continuous operation.
2.2.4 Physiological purpose
The use of the MPR2 is indicated, if the intention is to obtain information for the treatment, to assess the
appropriateness of the treatment, or to exclude the cause of symptoms.
2.2.5 Patient population
Please observe the information in the instructions for use of the catheter used for the application.
2.2.6 Application in connection with electrosurgical units
Devices that meet the requirements of IEC 60601-1-2:
2007
(for differentiation, see Section
10 Electromagnetic compatibility) are contraindicated for simultaneous use with electrosurgical devices.
(see section 2.3 Contraindications).
Only devices
that fulfill the requirements of IEC 60601-1-2:
2014
are
suitable for simultaneous use with electrosurgical units. The following notes must be observed:
•
If the MPR2 is used together with an electric surgical instrument, then a measurement inaccuracy
according to chapt. 10.1.1 Accuracy under the influence of electromagnetic interference phenomena
can occur.
•
Before using electrosurgical units, check that the test transducers used are equipped with appropriate
protective measures against patient burns. If the sensors do not have suitable protective measures,
they must be disconnected from the device before electrosurgical units are used.
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