RAUMEDIC MPR1 User manual

Instructions for Use MPR1 DATALOGGER
Manufacturer: zwo-399EN
RAUMEDIC AG, Hermann-Staudinger-Strasse 2, 95233 Helmbrechts, Germany Rev. 9, 2020-10-16
Page 1 of 98
Instructions for Use
MPR1 DATALOGGER
REF 094474-001 and 094474-002
Firmware versions
2.10.0070 and 2.10.0070 HW2
This document is for information only

Instructions for Use MPR1 DATALOGGER
Manufacturer: zwo-399EN
RAUMEDIC AG, Hermann-Staudinger-Strasse 2, 95233 Helmbrechts, Germany Rev. 9, 2020-10-16
Page 2 of 98
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 issue 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 ................................................................. 9
2.3 Contraindications ............................................................................................................................. 9
2.4 Main operating functions.................................................................................................................. 9
2.5 Operating elements, connections, displays..................................................................................... 9
2.5.1 Keys with dedicated functions ................................................................................................ 10
2.5.2 Keys with context-sensitive functions..................................................................................... 10
2.6 Information and warning symbols.................................................................................................. 13
2.6.1 Information and warning symbols on the front side................................................................ 13
2.6.2 Information and warning symbols on the bottom side and the type plate of the unit ............. 14
2.6.3 Remark- and warning symbols on the packaging label.......................................................... 15
2.7 Abbreviations ................................................................................................................................. 16
2.8 Code designations on the connection sockets of the MPR1 ......................................................... 16
2.9 Catheter location and signal designations..................................................................................... 16
3Patient monitoring............................................................................................................................... 17
3.1 ECG ............................................................................................................................................... 17
3.2 Cabled invasive pressure measurement ....................................................................................... 18
3.2.1 General aspects...................................................................................................................... 18
3.2.2 Preparation of the invasive pressure measurement............................................................... 19
3.2.2.1 Preparation of the invasive pressure measurement with external transducer.................. 19
3.2.2.2 Preparation of the invasive pressure measurement with micro-chip precision
pressure catheter .............................................................................................................. 20
3.2.2.3 Zero calibration ................................................................................................................. 21
3.2.2.3.1 Zeroing RAUMEDIC catheter..................................................................................... 21
3.2.2.3.2 Retention of zero value .............................................................................................. 22
3.2.2.3.3 Conventional zeroing ................................................................................................. 22
3.3Telemetric measurement of the ICP.............................................................................................. 23
3.3.1 General ................................................................................................................................... 23
3.3.2 Preparation for telemetric measurement of the ICPT............................................................. 23
3.4 Measurement of the body temperature.......................................................................................... 25
3.4.1 Preparing the temperature measurement .............................................................................. 25
3.4.2 Cleaning, disinfecting and sterilising the temperature sensor................................................ 26
3.5 Analogue outputs........................................................................................................................... 26
3.6 Interface for the extension of the apparatus .................................................................................. 26
3.7 PC interface ................................................................................................................................... 27
4Operation of the MPR1........................................................................................................................ 28
4.1 General aspects............................................................................................................................. 28
4.1.1 Switching on the apparatus .................................................................................................... 28
4.1.2 Screen selection ..................................................................................................................... 28
4.1.2.1 Information field................................................................................................................. 28
4.1.2.2 Navigation field ................................................................................................................. 28
4.1.2.3 Data field........................................................................................................................... 29
4.2 Start screen.................................................................................................................................... 29
4.2.1 General notes on the key functions........................................................................................ 30
4.2.2 Deleting the memory .............................................................................................................. 30
4.2.3 Open a new patient documentation........................................................................................ 31
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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 3 of 98
4.2.4 Selecting the memory mode................................................................................................... 32
4.2.5 No storage .............................................................................................................................. 34
4.2.6 View last measurement .......................................................................................................... 35
4.3 Alarm limit selection....................................................................................................................... 36
4.4 Connecting the transducer............................................................................................................. 37
4.4.1 Operating instructions – connection cable ............................................................................. 37
4.4.2 ECG ........................................................................................................................................ 38
4.4.2.1 ECG settings..................................................................................................................... 39
4.4.2.2 ECG alarms....................................................................................................................... 39
4.4.2.3 ECG graphics.................................................................................................................... 40
4.4.2.4 Heart rate trend................................................................................................................. 40
4.4.3 Transducer for invasive pressure measurement.................................................................... 41
4.4.3.1 Invasive pressure measurement settings ......................................................................... 43
4.4.3.2 Changing limiting alarm value settings for invasive pressure measurement.................... 45
4.4.3.2.1 Changing the pressure limiting value......................................................................... 45
4.4.3.2.2 Activating and deactivating the alarms ...................................................................... 46
4.4.3.3 Connecting analogue outputs ........................................................................................... 46
4.4.3.4 Pressure graphics ............................................................................................................. 47
4.4.3.5 Invasive pressure trend..................................................................................................... 48
4.4.3.6 Measuring the CPP........................................................................................................... 49
4.4.4 Transducer for temperature measurement............................................................................. 49
4.4.4.1 Changing the temperature settings................................................................................... 50
4.4.4.1.1 Setting the limiting temperature values...................................................................... 51
4.4.4.1.2 Activating and deactivating the temperature alarms.................................................. 51
4.4.4.2 Temperature graphics....................................................................................................... 51
4.4.4.3 Temperature trend ............................................................................................................ 52
4.4.5 Telemetric pressure measurement......................................................................................... 52
4.4.5.1 Making ICPT settings........................................................................................................ 55
4.4.5.2 Changing ICPT alarm limit settings .................................................................................. 55
4.4.5.2.1 Changing ICPT thresholds......................................................................................... 55
4.4.5.2.2 Activating and deactivating ICPT alarms ................................................................... 55
4.4.5.3 ICPT chart......................................................................................................................... 55
4.4.5.4 ICPT trend......................................................................................................................... 55
4.4.5.5 Measuring the CPP using the ICPT.................................................................................. 56
4.5 Configuring the graphics display.................................................................................................... 56
4.6 Device setup .................................................................................................................................. 57
4.6.1 Combine analogue outputs..................................................................................................... 57
4.6.2 Device diagnostics.................................................................................................................. 59
4.6.3 Setting the LCD contrast ........................................................................................................ 60
4.6.4 Setting the language version.................................................................................................. 60
4.6.5 Setting date and time.............................................................................................................. 61
4.6.6 Modifying the scaling .............................................................................................................. 63
4.7 Activating the key lock ................................................................................................................... 64
4.8 Switching on the LCD background illumination ............................................................................. 65
4.9 Alarm system ................................................................................................................................. 65
4.9.1 Physiological alarms............................................................................................................... 67
4.9.2 Factory settings ...................................................................................................................... 68
4.9.2.1 Factory settings and adjustment ranges for physiological alarms.................................... 68
4.9.2.2 Inactivate alarm signal switch ........................................................................................... 68
4.9.2.3 Scaling .............................................................................................................................. 69
4.9.3 Saving the alarm settings ....................................................................................................... 69
4.9.4 Technical alarms..................................................................................................................... 69
4.9.4.1 Apparatus alarms.............................................................................................................. 69
4.9.4.2 Sensor alarms................................................................................................................... 71
4.9.5 limitations................................................................................................................................ 71
4.9.6 Summarisation........................................................................................................................ 71
4.9.7 Verifying the alarm system ..................................................................................................... 72
5Power supply ....................................................................................................................................... 73
5.1 Mains power supply ....................................................................................................................... 73
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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 4 of 98
5.2 Displays when operating on mains power..................................................................................... 73
5.3 Battery operation............................................................................................................................ 73
5.4 Displays when operating on battery............................................................................................... 73
5.5 Influence of the storage conditions on the battery operation......................................................... 73
5.6 Battery maintenance...................................................................................................................... 74
5.7 Information on how to handle battery packs.................................................................................. 74
6Troubleshooting .................................................................................................................................. 75
6.1 Special instructions for the telemetric measurement of ICP.......................................................... 75
6.2 Error – Zero calibration of pressure channel ................................................................................. 76
6.3 Internal error – pressure channel................................................................................................... 76
6.4 Internal error – temperature........................................................................................................... 76
6.5 Memory full .................................................................................................................................... 76
6.6 Residual operating time – battery pack ......................................................................................... 76
6.7 Pressure sensor has been removed.............................................................................................. 77
6.8 Temperature sensor has been removed........................................................................................ 77
6.9 ECG cable disconnected ............................................................................................................... 77
6.10 Grave error A ................................................................................................................................. 77
6.11 Grave error B ................................................................................................................................. 77
6.12 Internal error – analogue output .................................................................................................... 77
6.13 Defective fuses .............................................................................................................................. 78
6.14 Reaction to fault messages and indications .................................................................................. 78
7Cleaning and maintenance................................................................................................................. 82
7.1 Cleaning the MPR1........................................................................................................................ 82
7.2 Cleaning, disinfecting and sterilising the cables and sensors ....................................................... 82
7.2.1 Cleaning.................................................................................................................................. 82
7.2.2 Disinfection ............................................................................................................................. 82
7.2.3 Sterilisation ............................................................................................................................. 83
7.3 Cleaning the mains adaptor........................................................................................................... 83
8Inspections, Safety and Measurement Checks ................................................................................ 84
8.1 General .......................................................................................................................................... 84
8.2 Safety check (SC).......................................................................................................................... 84
8.3 Measurement check (MC) ............................................................................................................. 84
9Accessories ......................................................................................................................................... 85
10 Electromagnetic compatibility ........................................................................................................... 86
10.1 Manufacturer's declaration on the EMC requirements according to IEC 60601-1-2:2014............ 86
10.1.1 Accuracy under the influence of electromagnetic interference phenomena .......................... 86
10.1.2 General information ................................................................................................................ 86
10.1.3 Electromagnetic emissions..................................................................................................... 87
10.1.4 Electromagnetic immunity ...................................................................................................... 87
10.2 Manufacturer's declaration on the EMC requirements according to IEC 60601-1-2:2007............ 88
10.3 Electromagnetic emissions ............................................................................................................ 89
10.4 Electromagnetic immunity.............................................................................................................. 90
11 Technical parameters (Specification)................................................................................................ 93
11.1 Technical data................................................................................................................................ 93
11.2 Environmental conditions............................................................................................................... 95
11.2.1 Operating and storage temperature ....................................................................................... 95
11.2.2 Humidity.................................................................................................................................. 95
11.2.3 Atmospheric pressure............................................................................................................. 95
12 Environment and disposal.................................................................................................................. 95
13 Liability and warranty.......................................................................................................................... 95
14 Index ..................................................................................................................................................... 96
15 Enclosures ........................................................................................................................................... 97
This document is for information only

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

Instructions for Use MPR1 DATALOGGER
Manufacturer: zwo-399EN
RAUMEDIC AG, Hermann-Staudinger-Strasse 2, 95233 Helmbrechts, Germany Rev. 9, 2020-10-16
Page 6 of 98
1 Safety-related information
Prior to using the DATALOGGER, 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 DATALOGGER.
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 MPR1 DATALOGGER (hereinafter referred to as MPR1 for short) may be operated by qualified
staff only.
•The MPR1 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.
•To completely disconnect the MPR1 from the mains, disconnect the mains power adapter from the wall
outlet.
•Prior to using the MPR1, you have to be completely familiar with the operation of the system.
•The MPR1 may be used on one patient at a time only.
•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 60601-1-1 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 60601-1-1.
•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. (see chapter 4.3 Alarm limit selection)
•If and when a defibrillator is used, short-time interferences of the signal shapes and values measured
may occur.
•The apparatus can forward up to two invasive 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 MPR1: Establish the cable connection; check the signal
transmission; and set the alarm limits to the foreign system.
•Prior to using the MPR1, 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.
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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 7 of 98
•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.
•Note that the optional accessory reader, TDT1 readP, can only be used for telemetric pressure
measurement with a pressure measurement implant.
•No liquids or fluids shall enter the apparatus. If this should happen nonetheless, first remove the mains
adapter from the socket. Hand over the apparatus to the after-sales service department for inspection.
Subsequently a safety-related check is necessary.
•The MPR1 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.
•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 3.5, 3.6 and 3.7.
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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 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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Manufacturer: zwo-399EN
RAUMEDIC AG, Hermann-Staudinger-Strasse 2, 95233 Helmbrechts, Germany Rev. 9, 2020-10-16
Page 9 of 98
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 MPR1 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.
2.3 Contraindications
The MPR1 is contra-indicated for use in CT 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 MPR1
is not intended for use in domestic settings.
2.4 Main operating functions
The main operating functions of the MPR1 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
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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 10 of 98
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.
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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 11 of 98
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
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 function). 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 depression
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
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Manufacturer: zwo-399EN
RAUMEDIC AG, Hermann-Staudinger-Strasse 2, 95233 Helmbrechts, Germany Rev. 9, 2020-10-16
Page 12 of 98
18 19 20 21 22
28 27 26 25 24 23
Figure 2: Connection field
[18] ECG: connection socket for ECG cable (cf. 4.4.2 ECG)
[19] P3: connection socket for invasive pressure (cf. 4.4.3 Transducer for invasive pressure )
[20] P1: connection socket for invasive pressure (cf. 4.4.3 Transducer for invasive pressure )
[21] Out-2: analogue output 2 (cf. 4.6.1 Combine analogue outputs)
[22] E: RS232 interface ( cf. 3.6 Interface for the extension of the apparatus)
[23] PC: USB interface (cf. 3.7 PC interface)
[24] Power: connection for mains adapter (cf. 4.1 General aspects)
[25] Out-1: analogue output 1 (cf. 4.6.1 Combine analogue outputs)
[26] P2: connection socket for invasive pressure (cf. 4.4.3 Transducer for invasive pressure )
[27] Temp-1: connection for temperature probe, channel 1 (cf. 4.4.4 Transducer for temperature
measurement)
[28] Temp-2: connection for temperature probe, channel 2 (cf. 4.4.4 Transducer for temperature
measurement)
Figure 3
Figure 4
Optional stand holder [29]
Optional table holder [30]
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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 13 of 98
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.
This document is for information only

Instructions for Use MPR1 DATALOGGER
Manufacturer: zwo-399EN
RAUMEDIC AG, Hermann-Staudinger-Strasse 2, 95233 Helmbrechts, Germany Rev. 9, 2020-10-16
Page 14 of 98
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 sockets [18] to [28] and on the
back side have the following significance:
The patient connections [18], [19], [20], [26], [27], [28]
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 RAUMEDIC MPR 1 DATALOGGER.
In this
respect, please observe the instructions for use.
Analogue outputs Out-1 [25] and Out-2 [21].
The caution signs above the analogue outputs Out-1 and Out-2 indicate that only accessory
parts authorised by the manufacturer may be connected up to RAUMEDIC MPR
1
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 socket indicates
that only mains adapter, art. No. 284007-002 respectively 284027-001
, authorised by the
manufacturer, may be used.
Ext. Bi-directional digital input / output.
The caution sign below socket Ext. indicates that only accessory parts authorised by the
manufacturer may be connected up to RAUMEDIC MPR 1 DATALOGGER.
In this respect,
please observe the instructions for use.
PC Bi-directional digital USB input / output.
The caution sign below socket PC indicates that only accessory parts authorised by the
manufacturer may be connected up to RAUMEDIC MPR 1 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 protect
ion 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 involved in using the
device about the above mentioned ESD measures.
Table 2: Information and warning symbols
This document is for information only

Instructions for Use MPR1 DATALOGGER
Manufacturer: zwo-399EN
RAUMEDIC AG, Hermann-Staudinger-Strasse 2, 95233 Helmbrechts, Germany Rev. 9, 2020-10-16
Page 15 of 98
2.6.3 Remark- and warning symbols on the packaging label
The symbols on the marking plate and the packaging label have the following significance:
Keep dry
Keep away from sunlight
Consult instruction for use
Manufacturer
Date of manufacture
Please observe disposal instructions. Do not put old units into the garbage.
Temperature limit
Reference number
Serial number
The device meets the essential Requirements of the European Directive 90/385/EEC and
93/42/EEC
Table 3: Information and warning symbols
This document is for information only

Instructions for Use MPR1 DATALOGGER
Manufacturer: zwo-399EN
RAUMEDIC AG, Hermann-Staudinger-Strasse 2, 95233 Helmbrechts, Germany Rev. 9, 2020-10-16
Page 16 of 98
2.7 Abbreviations
CD Compact Disc
CF Cardiac Floating
CT Computer tomography
EMC Electro-Magnetic Compatibility
ID Identification number
LCD Liquid Crystal Display
LED Light Emitting Diode
LP Long Play memory mode
MPBV German Medical Products Operator Regulations
MPG German Act on Medical Products
MC Measurement check
MRT Magnetic resonance tomography
N.C. Normal Condition
NiMH Nickel Metal Hydride
S.F.C. Single Fault Condition
SN Serial Number
SP Short Play memory mode
SC Safety check
TC Telemetry catheter
2.8 Code designations on the connection sockets of the MPR1
ECG connection socket for ecg cable
Ext. connection socket for device extension (RS232)
Out-1 connection socket for analogue output 1
Out-2 connection socket for analogue output 2
PC connection socket for USB cable
Power connection socket for mains adapter
P1 connection socket for pressure sensor P1
P2 connection socket for pressure sensor P2
P3 connection socket for pressure sensor P3
Temp-1 connection socket for temperature sensor T1
Temp-2 connection socket for temperature sensor T2
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)
ECG Electrocardiography
HR Heart rate
IBP Invasive Blood Pressure
ICP Intra-Cranial Pressure
ICPA Intra-Cranial Pressure Pulse Amplitude
ICPT Intracranial pressure, telemetrically measured
MAP Median Arterial Pressure
MP1 median pressure P1
MP2 median pressure P2
MP3 median pressure P3
UL upper limiting value
SYS systolic pressure
T1 Temperature T1
T2 Temperature T2
LL lower limiting value
CVP central venal pressure
This document is for information only

Instructions for Use MPR1 DATALOGGER
Manufacturer: zwo-399EN
RAUMEDIC AG, Hermann-Staudinger-Strasse 2, 95233 Helmbrechts, Germany Rev. 9, 2020-10-16
Page 17 of 98
3 Patient monitoring
Note: This chapter describes the units and their functions as well as the extension options of the MPR1.
A detailed description of the operation of the MPR1 is rendered in chapter 4Operation of the
MPR1, and the technical data are listed in chapter 11 Technical parameters (Specification).
3.1 ECG
This feature is only available in devices up to the 2011 production year. (see 2.1 Intended purpose).
Applied part type CF
Type: single-channel ECG without monitoring
Number: 1
Where: Fig. 2: Connection field, connection [18]
Application: see below
Application: The ECG is used to assess the patient’s activity (heart rate). In neuro-surgery, the ECG triggers
the allocation of the pulse amplitudes of the ICP pulse wave (start of P1), measuring the ICP at the same
time.
The ICP pulse wave resembles a venous wave and has five small peaks (P1 – P5) whereby P1 to P3 are
arterially induced and P4 to P5 venously. Normally the amplitude amounts to 3 to 4 mmHg. In case of space
taken (by SAB or tumours for example) the pulse amplitudes increase caused by the vasodilatation, and
P1 drops below P2. If the pCO2 increases, the pulse amplitude increases as well. In case of an active
hydrocephalus, the pulse amplitude may increase in a sinusoidal peak-free form up to 40 mmHg.
The pulse wave analysis is an indirect compliance parameter (dimension for the intra-cranial reserve space)
because the pulse amplitude rises with decreasing compliance continuously linear with the ICP.
The ECG channel is type CF and has been classified as protected against defibrillation. The ECG channel
of MPR1 can be used for simple bipolar lead (preferably according to Eindhoven II) with display of the heart
rate.
Use only those ECG accessories which have
been listed in the overview of accessories.
It is
only with these accessories that a protection
against the effects of a defibrillation is ensured.
Note:
The ECG channel has not been provided
with a monitoring function.
Caution!
The MPR1 has not been approved for
direct use on the heart.
Figure 5: Applying the electrodes
An overmodulation of the input amplifier is not indicated. Thus, there is no indication of any distorted or
overdriven signal curves.
For the recommended position of the electrodes, please refer to Fig. 5. In this way the thorax is kept free
for a potentially required reanimation. Connect the patient cable with the electrodes and the ECG
connection socket ECG [18]. In the process, please observe that the coding bridges of the connector
correctly fit into the grooves of the socket. Please also check the correct seat of all plug-in connections of
the patient cable.
The display of the MPR1 renders the heart rate HR on the overview screen in the ECG window (buttom
right-hand side). Please observe that the display of the first value will take a few seconds on account of the
automatic amplification control.
By pressing the screen selector button , the graphics screen can be changed. The display will show the
ECG curve, and if additional sensors have been fitted, the display will be split into the corresponding number
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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 18 of 98
of traces (maximum 4). The display of the ECG curve is carried out on the lower traces. The heart rate is
shown on the left-hand side of the screen. For the change of the parameter settings (filter) and the display,
please read chapter 4.4.2.1 ECG settings. After the ECG electrodes have been applied, the correct contact
and the right lead on the unit have to be verified by the visual inspection of the ECG signal. If the electrode
connecting cables have not been connected yet or if the electrodes do not make a correct contact, no ECG
display is possible and HR --- is displayed instead.
The ECG connection [18] corresponds to type CF, and in connection with the ECG cable it is protected
against damage caused during defibrillation. Nonetheless, please keep a minimum distance of 15 cm
between the ECG and the defibrillation electrodes. Caution ! The MPR1 is not suitable for a diagnosis of
the ECG during or after defibrillation!
Direct-current potentials caused by electro-chemical processes on the ECG electrodes may have a
negative effect on the ECG lead. For this reason, please only use the electrodes recommended in the list
of accessories. Do not use electrodes of different types on a patient. We recommend the adhesive
electrodes Exacon – Asmuth F50.
Specification of the ECG channel: cf. 11 Technical parameters (Specification)
Recommended accessories: cf. 9 Accessories
3.2 Cabled invasive pressure measurement
3.2.1 General aspects
Applied part type CF
Type: for pressure sensors with ratiometric characteristic 5 µV / V / mmHg
Number: 3
Where: Figure 2: Connection field, connections [19], [20] and [26]
Application: see below
The MPR1 can be used to measure and display up to three 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 only those pressure accessories which have been listed in the overview in chapter 9 Accessories.
Use transducers and cables only which have been protected again defibrillation. Observe the
instructions of the transducer and/or catheter manufacturer.
Disposable transducers are intended for one-time use only.
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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 19 of 98
The MPR1 has three input sockets P1, P2, P3, to which up to three transducers or micro-chip precision
pressure catheters can be connected. By means of the software, pressure 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 2
Table 4: 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. 11 Technical parameters (Specification)
Recommended accessories: cf. 9 Accessories
3.2.2 Preparation of the invasive pressure measurement
3.2.2.1 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; connect the connector with the yellow
marking to socket P1, P2 or P3 of the MPR1.
•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 MPR1
only.
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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 20 of 98
Figure 6: Pressure measurement with external transducer
3.2.2.2 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 catheter! Prepare the micro-chip precision pressure catheter in keeping with the
instructions of the catheter manufacturer.
•Connect the ICP-Temp cable to the catheter; connect the connector with the yellow marking to socket
P1, P2 or P3 of the MPR1.
When required, choose another measuring point.
Select the “Zeroing RAUMEDIC Catheter” zeroing option when the RAUMEDIC precision pressure
catheter has been connected!
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.
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