RAUMEDIC MPR2 logO User manual

Instructions for Use RAUMEDICMPR2 logO
Manufacturer: zwo-400EN
RAUMEDIC AG, Hermann-Staudinger-Strasse 2, 95233 Helmbrechts, Germany Rev. 9 2020-09-22
Page 1 of 99
Instructions for Use
RAUMEDIC®MPR2 logO
REF 095254-001 and 095254-002
Firmware version
2.10.0068 HW2
This document is for information only

Instructions for Use RAUMEDICMPR2 logO
Manufacturer: zwo-400EN
RAUMEDIC AG, Hermann-Staudinger-Strasse 2, 95233 Helmbrechts, Germany Rev. 9 2020-09-22
Page 2 of 99
Table of contents
0General notes .........................................................................................................................................5
1Safety-related information ....................................................................................................................6
2Description of the device ......................................................................................................................8
2.1 Intended purpose ............................................................................................................................. 8
2.1.1 Description ................................................................................................................................8
2.1.2 Intended use .............................................................................................................................8
2.1.3 Operational environment...........................................................................................................8
2.2 Indications ........................................................................................................................................ 8
2.2.1 Conditions .................................................................................................................................8
2.2.2 Body parts or types of tissue interacting with the unit...............................................................8
2.2.3 Frequency of use ......................................................................................................................8
2.2.4 Physiological purpose ...............................................................................................................8
2.2.5 Patient population .....................................................................................................................8
2.2.6 Application in connection with electrosurgical units..................................................................8
2.3 Contraindications.............................................................................................................................. 9
2.4 Main operating functions .................................................................................................................. 9
2.5 Operating elements, connections, displays ..................................................................................... 9
2.5.1 Keys with dedicated functions...................................................................................................9
2.5.2 Keys with context-sensitive functions .......................................................................................9
2.6 Information and warning symbols .................................................................................................. 12
2.6.1 Information and warning symbols on the front side ................................................................12
2.6.2 Information and warning symbols on the bottom side and the type plate of the unit..............13
2.6.3 Remark and warning symbols on the marking plate and the packaging label off the device.14
2.7 Abbreviations.................................................................................................................................. 15
2.8 Code designations on the connection ports of the MPR2.............................................................. 16
2.9 Catheter location and signal designations ..................................................................................... 16
3Patient monitoring ...............................................................................................................................17
3.1 Invasive pressure measurement IBP ............................................................................................. 17
3.1.1 General aspects......................................................................................................................17
3.1.2 Preparation of the invasive pressure measurement ...............................................................18
3.1.2.1 Preparation of the invasive pressure measurement with external transducer..................18
3.1.2.2 Preparation of the invasive pressure measurement with micro-chip precision pressure
catheter..............................................................................................................................18
3.1.2.3 Zero calibration..................................................................................................................19
3.1.2.3.1 Zeroing RAUMEDIC catheter .....................................................................................19
3.1.2.3.2 Retention of zero value...............................................................................................20
3.1.2.3.3 Conventional zeroing..................................................................................................20
3.2Measurement of the partial oxygen pressure................................................................................. 20
3.2.1 General aspects ......................................................................................................................20
3.2.2 Preparation of the catheter .....................................................................................................22
3.3 Measurement of the body temperature.......................................................................................... 23
3.3.1 Preparing the temperature measurement...............................................................................23
3.3.2 Cleaning, disinfecting and sterilising the temperature sensor ................................................24
3.4 Analogue outputs ........................................................................................................................... 24
3.5 Interface for the extension of the apparatus................................................................................... 24
3.6 PC interface.................................................................................................................................... 25
4Operation of the MPR2 ........................................................................................................................26
4.1 General aspects ............................................................................................................................. 26
4.1.1 Switching on the apparatus.....................................................................................................26
4.1.2 Screen selection......................................................................................................................26
4.1.2.1 Information field.................................................................................................................27
4.1.2.2 Navigation field..................................................................................................................27
4.1.2.3 Data field ...........................................................................................................................27
4.2 Start screen .................................................................................................................................... 28
4.2.1 General notes on the key functions ........................................................................................29
4.2.2 Deleting the memory...............................................................................................................29
4.2.3 Open a new patient documentation ........................................................................................31
4.2.4 Selecting the memory mode ...................................................................................................32
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Instructions for Use RAUMEDICMPR2 logO
Manufacturer: zwo-400EN
RAUMEDIC AG, Hermann-Staudinger-Strasse 2, 95233 Helmbrechts, Germany Rev. 9 2020-09-22
Page 3 of 99
4.2.5 No storage...............................................................................................................................33
4.2.6 View last measurement...........................................................................................................35
4.3 Selecting the limiting alarm values................................................................................................. 36
4.4 Connecting the transducer ............................................................................................................. 36
4.4.1 Operating instructions – connection cable..............................................................................37
4.4.2 Transducer for invasive blood pressure IBP...........................................................................37
4.4.2.1 Settings of invasive pressure measurement .....................................................................39
4.4.2.2 Changing the limiting alarm value settings of invasive pressure measurement ...............41
4.4.2.2.1 Changing the limiting value ........................................................................................41
4.4.2.2.2 Activating and deactivating the alarms.......................................................................42
4.4.2.3 Combine analogue outputs ...............................................................................................42
4.4.2.4 Invasive pressure measurement – Graphics.....................................................................43
4.4.2.5 Trend .................................................................................................................................44
4.4.2.6 Measuring the CPP ...........................................................................................................45
4.4.3 Partial oxygen pressure sensor ..............................................................................................45
4.4.3.1 Connecting the cable to the catheter ................................................................................45
4.4.3.2 Connecting the cable to the MPR2....................................................................................46
4.4.3.3 Setting the partial oxygen pressure...................................................................................46
4.4.3.4 Switching off individual measurement functions during pO2 measurement .....................48
4.4.3.4.1 Switching off pO2 measurement ................................................................................48
4.4.3.4.2 Switching off temperature measurement....................................................................48
4.4.3.4.3 Switching off pressure measurement ICP2................................................................49
4.4.3.5 pO2 limiting alarm values ..................................................................................................49
4.4.3.5.1 Setting the pO2 limiting values...................................................................................50
4.4.3.5.2 Activating and deactivating pO2 alarms .....................................................................50
4.4.3.6 pO2 graphics .....................................................................................................................51
4.4.3.7 pO2 trend...........................................................................................................................52
4.4.3.8 Technical alarms during partial oxygen pressure measurement ......................................53
4.4.4 Transducer for temperature measurement .............................................................................54
4.4.4.1 Changing the temperature settings ...................................................................................56
4.4.4.1.1 Setting the limiting temperature values ......................................................................56
4.4.4.1.2 Activating and deactivating the temperature alarms ..................................................57
4.4.4.2 Temperature graphics .......................................................................................................57
4.4.4.3 Temperature trend.............................................................................................................57
4.5 Configuring the graphics display .................................................................................................... 58
4.6 Device setup................................................................................................................................... 58
4.6.1 Combine analogue outputs .....................................................................................................58
4.6.1.1 Forwarding an individual pressure signal to Out1 or Out2................................................58
4.6.1.2 Special function OutpO .....................................................................................................60
4.6.2 Device diagnostics ..................................................................................................................62
4.6.3 Setting the LCD contrast.........................................................................................................63
4.6.4 Setting the language version ..................................................................................................64
4.6.5 Setting date and time ..............................................................................................................65
4.6.5.1 Setting the time..................................................................................................................65
4.6.5.2 Setting the date .................................................................................................................66
4.6.6 Modifying the scaling...............................................................................................................67
4.7 Key lock.......................................................................................................................................... 68
4.8 Switching on the LCD background illumination.............................................................................. 69
4.9 Alarm system.................................................................................................................................. 69
4.9.1 Physiological alarms ...............................................................................................................71
4.9.2 Factory settings.......................................................................................................................72
4.9.2.1 Factory settings and adjustment ranges for physiological alarms ....................................72
4.9.2.2 Alarm signal inactivation....................................................................................................72
4.9.2.3 Scaling...............................................................................................................................73
4.9.3 Saving the alarm settings........................................................................................................73
4.9.4 Technical alarms .....................................................................................................................73
4.9.4.1 Apparatus alarms ..............................................................................................................73
4.9.4.2 Sensor alarms ...................................................................................................................74
4.9.5 Summarisation ........................................................................................................................75
This document is for information only

Instructions for Use RAUMEDICMPR2 logO
Manufacturer: zwo-400EN
RAUMEDIC AG, Hermann-Staudinger-Strasse 2, 95233 Helmbrechts, Germany Rev. 9 2020-09-22
Page 4 of 99
4.9.6 Verifying the alarm system......................................................................................................75
5Power supply........................................................................................................................................76
5.1 Mains power supply........................................................................................................................ 76
5.2 Displays when operating on mains power...................................................................................... 76
5.3 Battery operation............................................................................................................................ 76
5.4 Displays when operating on battery............................................................................................... 76
5.5 Influence of the storage conditions on the battery operation ......................................................... 76
5.6 Battery maintenance ...................................................................................................................... 77
5.7 Information on how to handle battery packs .................................................................................. 77
6Troubleshooting...................................................................................................................................78
6.1 Special advice on the measurement of partial oxygen pressure ................................................... 78
6.2 Error – Zero calibration of pressure measurement unit ................................................................. 80
6.3 Internal error – pressure channel................................................................................................... 80
6.4 Internal error – temperature ........................................................................................................... 80
6.5 Memory full..................................................................................................................................... 80
6.6Residual operating time – battery pack.......................................................................................... 80
6.7 Pressure sensor has been removed .............................................................................................. 80
6.8 Temperature sensor has been removed........................................................................................ 81
6.9 Critical error A ................................................................................................................................ 81
6.10 Critical error B ................................................................................................................................ 81
6.11 Internal error – analogue output..................................................................................................... 81
6.12 Defective fuses............................................................................................................................... 81
6.13 Reaction to fault messages and indications................................................................................... 82
7Cleaning and maintenance .................................................................................................................86
7.1 Cleaning the MPR2 ........................................................................................................................ 86
7.2 Cleaning, disinfecting and sterilising the cables and sensors........................................................ 86
7.2.1 Cleaning ..................................................................................................................................86
7.2.2 Disinfection..............................................................................................................................86
7.2.3 Sterilisation..............................................................................................................................86
7.3 Cleaning the mains adapter ........................................................................................................... 86
8Safety and measurement related checks ..........................................................................................87
8.1 General aspects ............................................................................................................................. 87
8.2 Safety-related check....................................................................................................................... 87
8.3 Measurement-related check-up ..................................................................................................... 87
9Accessories..........................................................................................................................................88
10 Electromagnetic compatibility............................................................................................................89
10.1 Manufacturer's declaration on the EMC requirements according to IEC 60601-1-2:2014 ............ 89
10.1.1 Accuracy under the influence of electromagnetic interference phenomena...........................89
10.1.2 General information.................................................................................................................89
10.1.3 Electromagnetic emissions .....................................................................................................90
10.1.4 Electromagnetic immunity.......................................................................................................90
10.2 Manufacturer's declaration on the EMC requirements according to IEC 60601-1-2:2007 ............ 91
10.2.1 General information.................................................................................................................91
10.2.2 Electromagnetic emissions .....................................................................................................91
10.2.3 Electromagnetic immunity.......................................................................................................92
11 Technical parameters (Specification) ................................................................................................95
11.1 Technical data ................................................................................................................................ 95
11.2 Environmental conditions ............................................................................................................... 97
11.2.1 Operating and storage temperature........................................................................................97
11.2.2 Humidity ..................................................................................................................................97
11.2.3 Atmospheric pressure .............................................................................................................97
12 Environment and disposal..................................................................................................................97
13 Liability and warranty ..........................................................................................................................97
14 Index......................................................................................................................................................98
15 Enclosures............................................................................................................................................99
This document is for information only

Instructions for Use RAUMEDICMPR2 logO
Manufacturer: zwo-400EN
RAUMEDIC AG, Hermann-Staudinger-Strasse 2, 95233 Helmbrechts, Germany Rev. 9 2020-09-22
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

Instructions for Use RAUMEDICMPR2 logO
Manufacturer: zwo-400EN
RAUMEDIC AG, Hermann-Staudinger-Strasse 2, 95233 Helmbrechts, Germany Rev. 9 2020-09-22
Page 6 of 99
1 Safety-related information
Prior to using the MPR2 logO, please attentively read the entire instructions for use and familiarise
yourself with the operation of the appliance.
Prevent longer direct skin contact between patient and housing of the MPR2 logO.
In order to ensure safety, reliability and performance of the system, the following notes shall have to be
observed carefully:
Changes and modifications of the unit are not permitted.
•The MPR2 logO (hereinafter referred to as MPR2 for short) may be operated by qualified staff only.
•The MPR2 may be operated only with the specified mains power adapter, see chapter 11.1 Technical
data.
•Select only such wall outlet for the mains power adapter that is accessible to the user without difficulty.
Do not place the mains power adapter in a way that makes it difficult to disconnect the adapter from
the wall outlet.
•The mains power adapter is a part of the medical device. To completely disconnect the MPR2 from the
mains, disconnect the mains power adapter from the wall outlet.
•Prior to using the MPR2, you have to be completely familiar with the operation of the system.
•The MPR2 may be used on one patient at a time only.
•No splitting into spatially separate sensors for pressure and temperature may be effected at the multi-
purpose port P2/T2.
•When monitoring vital functions, a redundancy of the measuring functions is required. In this respect
the pO2 channel is a special feature. A real redundancy cannot be effected in the MPR2. However,
through the evaluation of the intensity of the optical receiving signal and the monitoring of the reference
LED, a far-reaching monitoring has been ensured.
•When the apparatus is switched on, a signal is sounded which is intended to check the alarm sounding
unit. If the signal is not sounded, the apparatus must not be used.
•If two or more apparatuses with separate mains connections are used on the same patient, the
apparatus leakage current adds up which may cause a potential hazard. In this case, use shall be
permitted only, if it has been secured that patient and operator are safe, and that the requirements of
standard IEC 60601-1 are fulfilled.
•Every person who connects an additional unit to the signal input or signal output configures a medical
system, and thus he / she shall be responsible for the fact that this system meets the requirements of
standard IEC 60601-1.
•Simultaneous operation with other apparatuses connected to the patient may cause mutual influences
which may have an effect on the measuring results.
•Note that in the event of different alarm pre-settings for the same or similar devices, which are used in
different hospital areas (e.g. ITS or the operating suite), the interchanging of settings can cause a
potential danger to patients. Therefore always check that the alarm settings are suitable for the patients
concerned prior to starting monitoring. (s. chapter 4.3 Selecting the limiting alarm values)
•The unit can forward up to two pressure signals to a downstream redundant monitoring system. By
means of the downstream system, it is possible to easily integrate the datalogger into a central
monitoring system. In the process special attention has to be given to the fact that only approved
systems from the listed accessories are connected. In case of every signal relaying, proceed as
rendered in the instructions for use of the MPR2: Establish the cable connection; check the signal
transmission; and set the alarm limits to the foreign system.
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Instructions for Use RAUMEDICMPR2 logO
Manufacturer: zwo-400EN
RAUMEDIC AG, Hermann-Staudinger-Strasse 2, 95233 Helmbrechts, Germany Rev. 9 2020-09-22
Page 7 of 99
•Prior to using the MPR2, the correct condition of the apparatus and any accessories shall have to be
checked. Check the plausibility of the readings before using the apparatus for monitoring. The
apparatus and the accessories must not be damaged or soiled; otherwise the apparatus must not be
used. Do not use the apparatus, if it reveals obvious signs of a wrong function; in this case forward the
unit to the after-sales service of the manufacturer.
•In questions of servicing, please always get in touch with the manufacturer. The manufacturer will give
you a list of authorised service partners, if and when required.
•In all fastening and erection variants, please make sure that the apparatus cannot drop or cause other
hazards. Please also ensure a safe laying of the cables so that a tipping over of the arrangement is
prevented.
•Do not use the apparatus in potentially explosive surroundings. The apparatus shall have to be set up
at a minimum distance of 25 cm to any anaesthesia units and gas filled hoses.
•After use the accessories shall have to be cleaned, disinfected or sterilised in keeping with the
instructions for use. If the accessory has been provided with separate instructions for use, the
instructions rendered there shall be applicable.
•If the apparatus has been taken from colder into warmer surroundings, it may be used only when the
temperature of the apparatus and of the accessories has adapted to the room temperature; there is no
danger of condensation water forming or any condensation water already developed has completely
dried.
•Please also observe the safety instructions in conjunction with the use of sensors and transducers
which have been included to the respective sections of the instructions for use.
•No liquids or fluids shall enter the apparatus. If this should happen nonetheless, first remove the mains
adapter from the port. Hand over the apparatus to the after-sales service department for inspection.
Subsequently a safety-related check is necessary.
•The MPR2 has been designed in conformity with standard IEC 60601-1. It is a product of class of
protection II with an internal power source and an external mains adapter, and has been allocated to
class IIb (MPG).
•If sterile accessories are used, please make sure that they are marked as being sterile.
•If the apparatus is subjected to strong electro-magnetic fields, please observe that the pressure display
may vary by up to 2 mmHg. For this reason, avoid using mobile phones, therapeutical microwave
devices or similar units in the vicinity of the apparatus.
•The following instructions shall have to be observed for the installation of the system (with laptop and/or
foreign unit – monitor):
•Moveable multiple sockets must not lay on the floor.
•Additional moveable multiple sockets or extension cables must not be connected up to the system.
•Apparatuses, which are not part of the system, must not be connected.
•The moveable multiple sockets have to be suitable for the load of the system.
•The moveable multiple sockets which are supplied along with the system only may be used for the
supply of the devices of the system.
•Observe the instructions for the installer on how to set up the system in an ideal way. Please also
read chapters 3.4, 3.5 and 3.6.
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Instructions for Use RAUMEDICMPR2 logO
Manufacturer: zwo-400EN
RAUMEDIC AG, Hermann-Staudinger-Strasse 2, 95233 Helmbrechts, Germany Rev. 9 2020-09-22
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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Instructions for Use RAUMEDICMPR2 logO
Manufacturer: zwo-400EN
RAUMEDIC AG, Hermann-Staudinger-Strasse 2, 95233 Helmbrechts, Germany Rev. 9 2020-09-22
Page 9 of 99
2.3 Contraindications
The MPR2 is contra-indicated for use in MRT or MRI and must not be operated in a corresponding
environment.
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.
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.
2.4 Main operating functions
The main operating functions of the MPR2 are:
•the installation of the unit, connect system components
•the installation of the device, connect system components;
•switch on the device;
•connect the catheter;
•selecting the recording mode;
•connecting to a third-party system;
•selecting the catheter zeroing;
•determining the measurement location;
•erasing the memory;
•create patient file;
•performing a simple functional pre-test of the alarm signals;
•configure alarms;
•deactivating the alarms;
•measure;
•display trend;
•set storage mode;
•monitor the temperature output value;
•perform a simple functional pre-test of the medical thermometer;
•switch off the device;
•cleaning and disinfecting
The configuration of the unit is no main operating function.
2.5 Operating elements, connections, displays
The following two pages will render an overview of the most important operating elements and displays.
The unit has been fitted with two types of keys:
1. Keys with dedicated functions and
2. Keys with context-sensitive functions
2.5.1 Keys with dedicated functions
These five keys are arranged on the left-hand bank of keys and are marked with their functions.
The key functions are described in Table 1.
2.5.2 Keys with context-sensitive functions
The unit has eight context-sensitive defined function keys (F keys). The F keys are located in the right-hand
bank of keys directly next to the display. Their current functions are shown in the appertaining monitor area.
This document is for information only

Instructions for Use RAUMEDICMPR2 logO
Manufacturer: zwo-400EN
RAUMEDIC AG, Hermann-Staudinger-Strasse 2, 95233 Helmbrechts, Germany Rev. 9 2020-09-22
Page 10 of 99
Figure 1: Operating elements, connections, displays
[1]
The Shift key switches this operation control key to the second level. The Shift
key is a toggle key (thus it switches on and off alternately); however, the Shift
status is automatically left without depression of the key after 15 seconds.
[2]
The right arrow key sets the display to the next image. When the last image
is made, the first image is displayed again.
[3]
The light bulb symbol switches the background lighting on/off in battery-
operated mode (toggle fu
nction). After 60 seconds the lighting is switched off
automatically. During mains operation this key has no function.
[4]
The bell symbol switches the AUDIO OFF function of the active alarm
conditions (in keeping with standard IEC 60601-1-8), long depr
ession sets
global AUDIO PAUSING or global AUDIO OFF).
[5]
The Symbol on/off key is used to switch the unit on and off. To switch the unit
off, keep the key pressed for 2 seconds.
[6] Power On LED (green) combined with the optical display for alarms
with
higher priority (red LED).
[7]
Display for alarms with high priority (flashing red LED) or average priority
(flashing yellow LED).
[8] Display
[9] to
[16]
Soft keys, also referred to as F keys.
[17] Connection field
Table 1: Keys and functions
789
10
11
12
17
13
14
15
16
6
5
4
3
2
1
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Instructions for Use RAUMEDICMPR2 logO
Manufacturer: zwo-400EN
RAUMEDIC AG, Hermann-Staudinger-Strasse 2, 95233 Helmbrechts, Germany Rev. 9 2020-09-22
Page 11 of 99
Figure 2: Connection field
[18] not equipped
[19] pO2: connection port for partial oxygen pressure (cf. chapter 4.4.3 Partial oxygen pressure sensor)
[20] P2/T2: multi-purpose port for invasive pressure P2 (cf. chapter 4.4.2 Transducer for invasive blood
pressure IBP) and temperature T2 (cf. chapter 4.4.4 Transducer for temperature measurement)
[21] P1: multi-purpose port for invasive pressure P1 (cf. chapter 4.4.2 Transducer for invasive blood
pressure IBP)
[22] Out-2: analogue output 2 (cf. chapter 4.6.1 Combine analogue outputs)
[23] Power: port for mains adapter (cf. chapter 4.1 General aspects )
[24] PC: USB interface (cf. chapter 3.6 PC interface)
[25] E: RS232 interface (cf. chapter 3.5 Interface for the extension of the apparatus)
[26] Out-1: analogue output 1 (cf. chapter 4.6.1 Combine analogue outputs)
[27] Temp-1: port for temperature probe, channel 1 (cf. chapter 4.4.4 Transducer for temperature
measurement)
19 20 21 22
27
23
26 2425
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Instructions for Use RAUMEDICMPR2 logO
Manufacturer: zwo-400EN
RAUMEDIC AG, Hermann-Staudinger-Strasse 2, 95233 Helmbrechts, Germany Rev. 9 2020-09-22
Page 12 of 99
Figure 3: Optional stand holder [28] Figure 4: Optional table holder [29]
2.6 Information and warning symbols
2.6.1 Information and warning symbols on the front side
The symbol below the shift key [1] has the following significance:
The instructions for use must be read.
The triangular LED at the left-hand top has the following significance:
Display for alarms: Flashing yellow LED, if alarm has average priority. Flashing red LED, if alarm
has high priority. LED off, if no alarm.
The round LED at the left-hand top has the following significance:
LED to signal ON / OFF and stand-by (flashing green LED for battery-pack operation and stand-
by, green LED 100 per cent mains operation. Flashing red LED, if alarm has high priority.
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Instructions for Use RAUMEDICMPR2 logO
Manufacturer: zwo-400EN
RAUMEDIC AG, Hermann-Staudinger-Strasse 2, 95233 Helmbrechts, Germany Rev. 9 2020-09-22
Page 13 of 99
2.6.2 Information and warning symbols on the bottom side and the type plate of the unit
The symbols on the bottom side of the apparatus at the cable connection ports [17] to [27] have the following
significance:
The patient connections [19], [20], [21], [27]
are of type CF and have been classified as being
defibrillation protected.
The caution sign above the patient connections indicates that only accessory parts authorised
by the manufacturer may be connected up to the RAUMEDIC MPR2 logO DATALOGGER
. In
this respect, please observe the instructions for use.
Analogue outputs Out-1 [26] and Out-2 [22].
The caution sign above the analogue outputs Out-1 and Out-2 indicates that only accessory
parts authorised by the manufacturer may be connected up to the RAUMEDIC MPR2 logO
DATALOGGER. In this respect, please observe the instructions for use.
Power input for connection of the mains adapter.
Caution – observe the instructions for use! The caution sign next to the Power port indicates
that only mains adapter, art. No. 284007-002 or 284027-001 may be used
(according to the
type plate of the MPR2).
Ext. Bi-directional digital input / output.
The caution sign below port E indicates that only accessory parts authorised by the
manufacturer may be connected up to RAUMEDIC MPR2 logO DATALOGGER. In this respect,
please observe the instructions for use.
PC Bi-directional digital USB input / output.
The caution sign below the PC port indicates that only accessory parts authorised by the
manufacturer may be connected up to the RAUMEDIC MPR2 logO DATALOGGER
. In this
respect, please observe the instructions for use.
Please observe the disposal instructions. Do not put old units into the garbage.
Please observe the instructions on ESD protection.
ESD protection measures: Contact pins of plugs/sockets, which are provided with an ESD
warning label, must not be touched. Connections between these plugs must not be made
without using ESD protection measures. In particular, the causing of high electrostatic
discharges at the labelled points must be
avoided. This is supported through the use of
appropriate ESD work clothing, an appropriate ESD working environment (ESD floors) and ESD
packaging. It is recommended that the operator instructs all employees in
volved in using the
device about the above mentioned ESD measures.
Table 2: Information and warning symbols
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Instructions for Use RAUMEDICMPR2 logO
Manufacturer: zwo-400EN
RAUMEDIC AG, Hermann-Staudinger-Strasse 2, 95233 Helmbrechts, Germany Rev. 9 2020-09-22
Page 14 of 99
2.6.3 Remark and warning symbols on the marking plate and the packaging label off the device
The symbols on the marking plate and the packaging label have the following significance:
Manufacturer
Date of manufacture
Reference number
Serial number
Consult instructions for use!
Keep dry
Keep away from sunlight
Temperature limit during transport and storage
Please observe the disposal instructions. Do not put old units into the garbage.
The device meets the essential Requirements of the European Directive 93/42/EEC
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Instructions for Use RAUMEDICMPR2 logO
Manufacturer: zwo-400EN
RAUMEDIC AG, Hermann-Staudinger-Strasse 2, 95233 Helmbrechts, Germany Rev. 9 2020-09-22
Page 15 of 99
2.7 Abbreviations
CD Compact Disc
CF Cardiac Floating
CT Computer tomography
EMC Electro-Magnetic Compatibility
LCD Liquid Crystal Display
LED Light Emitting Diode
LP Long Play memory mode
FOC Fibre-Optical Cable
MPBV German Medical Products Operator Regulations
MPG German Act on Medical Products
MRT Magnetic Resonance Tomography
MTK Electrical measurement check
N.C. Normal Condition
NFFS Nand Flash File System
NiMH Nickel Metal Hydride
PHB Phiboard (optoelectronic oxygen sensor module)
S.F.C. Single Fault Condition
SN Serial Number
SP Short Play memory mode
STK Safety-related check
SW Software
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Instructions for Use RAUMEDICMPR2 logO
Manufacturer: zwo-400EN
RAUMEDIC AG, Hermann-Staudinger-Strasse 2, 95233 Helmbrechts, Germany Rev. 9 2020-09-22
Page 16 of 99
2.8 Code designations on the connection ports of the MPR2
Ext. connection port for device extension (RS232)
Out-1 connection port for analogue output 1
Out-2 connection port for analogue output 2
PC connection port for USB cable
Power connection port for mains adapter
P1 connection port for pressure sensor P1
P2/T2 multi-purpose port for pressure sensor P2 / temperature sensor T2
pO2 connection port for fibre-optical partial oxygen pressure sensor
T1 connection port for temperature sensor T1
2.9 Catheter location and signal designations
ART Arterial pressure
CPP Cerebral Perfusion Pressure
DIA Diastolic pressure
GP1, GP2, GP3 general pressure parameters (without specific catheter location)
IBP Invasive Blood Pressure
ICP Intra-Cranial Pressure
ICPA Intra-Cranial Pressure Pulse Amplitude
MAP Median Arterial Pressure
MD1 Median pressure D1
MD2 Median pressure D2
MD3 Median pressure D3
UL Upper limiting value
pO2, ptiO2 Partial oxygen pressure
SYS Systolic pressure
T1 Temperature T1
T2 Temperature T2
LL Lower limiting value
CVP Central venal pressure
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Instructions for Use RAUMEDICMPR2 logO
Manufacturer: zwo-400EN
RAUMEDIC AG, Hermann-Staudinger-Strasse 2, 95233 Helmbrechts, Germany Rev. 9 2020-09-22
Page 17 of 99
3 Patient monitoring
Note: This chapter describes the units and their functions as well as the extension options of the MPR2.
A detailed description of the operation of the MPR2 is rendered in chapter 4 Operation of the
MPR2, and the technical data are listed in chapter 11.1 Technical data.
3.1 Invasive pressure measurement IBP
3.1.1 General aspects
Applied part type CF
Type: for pressure sensors with radiometric characteristic 5 µV / V / mmHg
Number: 2
Where: Figure 2: Connection field, connection ports [20] and [21]
Application: see below
The MPR2 can be used to measure and display up to two invasive pressures. The pressure channels are
type CF and have been classified as protected against defibrillation.
Invasive procedures comprise risks for the patients. Apply aseptic techniques, and observe the
instructions of the catheter manufacturer.
Use accessories only which are listed in the overview in chapter 9 Accessories. No splitting into spatially
separate sensors for pressure and temperature may be effected at the multi-purpose port P2/T2.
Use transducers and cables only which have been protected against defibrillation. Observe the
instructions of the transducer and/or catheter manufacturer.
Disposable transducers are intended for one-time use only.
The MPR2 has two input sockets P1, P2/T2, to which up to two transducers or micro-chip precision pressure
catheters can be connected. By means of the software, pressure measurement inputs can be allocated to
different measuring locations.
Designation Definition
ART arterial pressure
CVP central venal pressure
ICP1 intra-cranial pressure 1
ICP2 intra-cranial pressure 2
GP1 standard label - pressure 1
GP2 standard label - pressure 2
GP3 standard label - pressure 3
Table 3: Designation of the measuring location
The allocation of the measuring location of the pressure channel sets its scale, alarm source and alarm
limits.
Specification of the pressure channels: cf. chapter 11 Technical parameters (Specification)
Recommended accessories: cf. chapter 9 Accessories
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Instructions for Use RAUMEDICMPR2 logO
Manufacturer: zwo-400EN
RAUMEDIC AG, Hermann-Staudinger-Strasse 2, 95233 Helmbrechts, Germany Rev. 9 2020-09-22
Page 18 of 99
3.1.2 Preparation of the invasive pressure measurement
3.1.2.1 Preparation of the invasive pressure measurement with external transducer
•Prepare the monitor set in keeping with the instructions of the manufacturer. Ensure that no air is locked
in the hose system.
•Connect the Datalogger transducer cable to the transducer; plug the connector with the yellow mark
into port P1 or P2/T2 of the MPR2.
•Position the transducer at the height of the measuring location.
•Connect the patient catheter to the pressure hose.
•Adjust the transducer to zero.
•Use the three-way cock to open the hose to the patient.
In conjunction with external transducers, use the “Conventional zeroing“ option on the MPR2
only.
Figure 5: Pressure measurement with external transducer
3.1.2.2 Preparation of the invasive pressure measurement with micro-chip precision pressure
catheter
•Please observe the instructions of the catheter manufacturer in the instructions for use for micro-chip
precision pressure catheters! Prepare the micro-chip precision pressure catheter in keeping with the
instructions of the catheter manufacturer.
•Connect the ICP-Temp cable or the PTO cable to the catheter; plug the connector with the yellow mark
into the port P1 or P2/T2 of the MPR2.
When required, choose another measuring point.
Select the “Zeroing RAUMEDIC Catheter” zeroing option when the RAUMEDIC precision pressure
catheter has been connected!
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Instructions for Use RAUMEDICMPR2 logO
Manufacturer: zwo-400EN
RAUMEDIC AG, Hermann-Staudinger-Strasse 2, 95233 Helmbrechts, Germany Rev. 9 2020-09-22
Page 19 of 99
Please observe the instructions for use of the accessories, such as cable and catheter. If limitations
apply in the permissible measuring range or in the protection against defibrillation, for example, the
said shall have to be adhered to by all means.
Figure 6: Measurement with micro-chip precision pressure catheter
3.1.2.3 Zero calibration
There are three options to be selected from in the Zero calibration menu of the MPR2:
•Zeroing RAUMEDIC catheter
•Retention of zero value
•Conventional zeroing
3.1.2.3.1 Zeroing RAUMEDIC catheter
During their manufacture, RAUMEDIC catheters are subjected to extensive measurements. Based on the
evaluation of these measurement results, the parameters of RAUMEDIC catheters are precisely set in the
works; the offset error is extremely low.
Based on this property, the Zeroing RAUMEDIC catheter option is rendered in the Zero calibration menu.
In the process no relative zeroing takes place as is the case in conventional zeroing.
Use this option only, if you are well aware of the function of this process.
Use this option only in conjunction with RAUMEDIC catheters and under observation of the special
instructions in the instructions for use of the catheter manufacturer.
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Instructions for Use RAUMEDICMPR2 logO
Manufacturer: zwo-400EN
RAUMEDIC AG, Hermann-Staudinger-Strasse 2, 95233 Helmbrechts, Germany Rev. 9 2020-09-22
Page 20 of 99
3.1.2.3.2 Retention of zero value
In case of nursing measures it may be necessary to sever the connection of the measuring chain on the
pressure catheter or on the MPR2. The pressure catheter remains in the implanted condition. A subsequent
conventional zeroing of the pressure catheter in implanted condition is not possible, however. For this
reason, the zero value of the first zeroing process in non-implanted condition has to be retained. This zero
value saved in the MPR2 will be taken over when the pressure catheter is connected again and when the
“Retention of zero value” option is selected.
Use this option only, if you are well aware of the function of this process.
Use this option only with the same pressure catheter.
3.1.2.3.3 Conventional zeroing
If conventional zeroing is carried out, the output signal of the pressure sensor is declared zero at this point
in time. Frequently external transducers or pressure catheters provide an output signal deviating from zero;
they produce an offset value. In case of conventional zeroing, this offset is removed for the current
measurement (internal correction).
Use this option only, if you are well aware of the function of this process.
Please ensure that zero pressure pushes up at the pressure sensor prior to starting conventional zeroing.
In pressure catheters, conventional zeroing may be carried out in non-implanted condition only.
3.2 Measurement of the partial oxygen pressure
3.2.1 General aspects
Applied part type CF
Type: fibre-optical sensor
Number: 1
Where: Figure 2: Connection field, connection ports [19] and [20]
Application: see below
When a special fibre-optical catheter (NEUROVENT-PTO) made by RAUMEDIC has been fitted, the MPR2
can be used to measure and display the partial oxygen pressure. The pressure channel is CF type and has
been classified as defibrillation protected.
Please observe the safety-related instructions (cf. chapter 1 Safety-related information).
Invasive procedures comprise risks for the patients. Apply aseptic techniques, and observe the
instructions of the catheter manufacturer.
Use only those accessories which have been listed in the overview in chapter 9 Accessories. No splitting
into spatially separate sensors for pressure and temperature may be effected at the multi-purpose port
P2/T2.
Please observe the instructions of the catheter manufacturer.
Please observe the notes on the special features of optical fibres rendered in the instructions for use of
the PTO catheter.
Please observe the notes on cleaning and protection of the optical plug-in connector rendered in the
instructions for use of the FOC.
The fibre-optical sensor is always connected to the following two sockets: Connection of the optical signal
through FOC to ST port Figure 2: Connection field, connection port [19]; the PTO cable to P2/T2 port Figure
2: Connection field, connection port [20]. Fibre-optical sensors of RAUMEDIC only may be connected. In
the process, please observe that apart from the FOC the PTO cable always has to be connected. All
information on the type of catheter, its usability, the measuring location and the calibration parameters have
been saved to the digital memory which is read out by the MPR2 via the PTO cable. When a catheter of
the NEUROVENT-PTO type is connected, for example, the digital memory will allocate the ICP2 measuring
location to the invasive pressure automatically. A partial oxygen pressure measurement without the PTO
cable is not possible.
This document is for information only