Instructions for Use MPR1 DATALOGGER
Manufacturer:
RAUMEDIC AG, Hermann-Staudinger-Strasse 2, 95233 Helmbrechts, Germany
Page 8 of 98
2 Description of the device
2.1 Intended purpose
2.1.1 Description
The MPR1 is used for monitoring up to three invasively measured physiological pressures and up to two
temperatures of the patient (with alarm function).
Devices that were produced until the year 2011 also have
the function of a single-channel ECG with heart rate determination without alarm function.
These cabled
applications are covered by the device CE approval in accordance with MDD.
Optionally a single-channel telemetric pressure measurement can be made instead of a measurement via
a cabled pressure measurement channel, provided that the MPR1 has a high enough firmware version
(from firmware version 2.00.00XX, 2.00.00XX HW2, 2.10.00XX respectively 2.10.00XX HW2) and the
necessary accessories (accessories see 3.3.1
General) are available. This telemetric pressure
measurement is solely for ICP measurement using a pressure measurement implant and is covered by the
CE-approval in accordance with AIMDD.
For telemetric use of the MPR1, its use is limited to stationary operation. For all other applications the MPR1
can be used both for stationary patient monitoring as well as for mobile operation in the hospital. After the
vital parameters mentioned have been measured and monitored, the MPR1 ensures a long-time storage
of the values measured.
2.1.2 Intended use
The MPR1 is a diagnostic unit with physiological threshold value monitoring and display of the following
physiological parameters: invasive pressure (IBP and ICP, three channels) and temperature (T, 2
channels). Invasive 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 MPR1 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 MPR1 is not intended for use in domestic settings.
2.2 Indications
2.2.1 Conditions
The use of the MPR1 is indicated, when the doctor considers it necessary to measure and monitor several
physiological parameters, such as pressure and temperature.
2.2.2 Body parts or types of issue interacting with the unit
MPR1 has no body or tissue contact with the patient. Signals are received from sensors.
2.2.3 Frequency of use
The use of the MPR1 is indicated when the attending physician prescribes the application. The MPR1 has
been designed for continuous operation.
2.2.4 Physiological purpose
The use of the MPR1 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 refer to the instructions for use of the catheter used for the application.
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