MPR2 logO Instructions for Use ver 2.10.0067 HW2 Rev 7 Oct 2018

Instructions for Use RAUMEDIC MPR2 logO Table of contents 0 General notes ... 5 1 Safety-related information ... 6 2 Description of the device ... 9 2.1 Intended purpose ... 9 2.1.1 Description ... 9 2.1.2 Intended use ... 9 2.1.3 Operational environment ... 9 2.2 Indications ... 9 2.2.1 Conditions ... 9 2.2.2 Body parts or types of tissue interacting with the unit... 9 2.2.3 Frequency of use ... 9 2.2.4 Physiological purpose ... 9 2.2.5 Patient population ... 9 2.3 Contraindications... 9 2.4 Main operating functions ... 10 2.5 Operating elements, connections, displays ... 10 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 2.7 Abbreviations ... 15 2.8 Code designations on the connection ports of the MPR2 ... 15 2.9 Catheter location and signal designations ... 15 3 Patient monitoring ... 16 3.1 Invasive pressure measurement IBP ... 16 3.1.1 General aspects ... 16 3.1.2 Preparation of the invasive pressure measurement ... 16 3.1.2.1 Preparation of the invasive pressure measurement with external transducer ... 16 3.1.2.2 Preparation of the invasive pressure measurement with micro-chip precision pressure catheter... 17 3.1.2.3 Zero calibration ... 18 3.1.2.3.1 Zeroing RAUMEDIC catheter ... 18 3.1.2.3.2 Retention of zero value... 19 3.1.2.3.3 Conventional zeroing ... 19 3.2 Measurement of the partial oxygen pressure ... 19 3.2.1 General aspects ... 19 3.2.2 Preparation of the catheter ... 21 3.3 Measurement of the body temperature ... 22 3.3.1 Preparing the temperature measurement ... 22 3.3.2 Cleaning, disinfecting and sterilising the temperature sensor ... 23 3.4 Analogue outputs ... 23 3.5 Interface for the extension of the apparatus ... 23 3.6 PC interface... 24 3.7 Laptop for on-line and off-line display of the values measured ... 24 3.8 DATALOG software... 25 4 Operation of the MPR2 ... 26 4.1 General aspects ... 26 4.1.1 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 Manufacturer: zwo-400EN RAUMEDIC AG, Hermann-Staudinger-Strasse 2, 95233 Helmbrechts, Germany Rev. 7 22/10/2018 Page 2 of 97

Instructions for Use RAUMEDIC MPR2 logO 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 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 ... 47 4.4.3.4.1 Switching off pO2 measurement ... 47 4.4.3.4.2 Switching off temperature measurement... 48 4.4.3.4.3 Switching off pressure measurement ICP2 ... 48 4.4.3.5 pO2 limiting alarm values ... 49 4.4.3.5.1 Setting the pO2 limiting values ... 49 4.4.3.5.2 Activating and deactivating pO2 alarms ... 50 4.4.3.6 pO2 graphics ... 50 4.4.3.7 pO2 trend... 51 4.4.3.8 Technical alarms during partial oxygen pressure measurement ... 52 4.4.4 Transducer for temperature measurement ... 53 4.4.4.1 Changing the temperature settings ... 55 4.4.4.1.1 Setting the limiting temperature values ... 55 4.4.4.1.2 Activating and deactivating the temperature alarms ... 56 4.4.4.2 Temperature graphics ... 56 4.4.4.3 Temperature trend ... 56 4.5 Configuring the graphics display ... 57 4.6 Device setup... 57 4.6.1 Combine analogue outputs ... 57 4.6.1.1 Forwarding an individual pressure signal to Out1 or Out2 ... 57 4.6.1.2 Special function OutpO ... 59 4.6.2 Device diagnostics ... 61 4.6.3 Setting the LCD contrast ... 62 4.6.4 Setting the language version ... 63 4.6.5 Setting date and time ... 64 4.6.6 Modifying the scaling ... 66 4.7 Key lock ... 67 4.8 Switching on the LCD background illumination... 68 4.9 Alarm system ... 68 4.9.1 Physiological alarms ... 70 4.9.2 Factory settings ... 71 4.9.2.1 Factory settings and adjustment ranges for physiological alarms ... 71 4.9.2.2 Alarm signal inactivation... 71 4.9.2.3 Scaling ... 72 4.9.3 Saving the alarm settings ... 72 Manufacturer: RAUMEDIC AG, Hermann-Staudinger-Strasse 2, 95233 Helmbrechts, Germany Page 3 of 97

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Instructions for Use RAUMEDIC MPR2 logO 4.9.4 Technical alarms ... 72 4.9.4.1 Apparatus alarms ... 72 4.9.4.2 Sensor alarms ... 73 4.9.5 Summarisation ... 74 4.9.6 Verifying the alarm system ... 74 5 Power supply ... 75 5.1 5.2 5.3 5.4 5.5 5.6 5.7

Mains power supply ... 75 Displays when operating on mains power ... 75 Battery operation ... 75 6.4 Displays when operating on battery ... 75 6.5 Influence of the storage conditions on the battery operation ... 75 Battery maintenance ... 76 Information on how to handle battery packs ... 76

6 Troubleshooting... 77 6.1 Special advice on the measurement of partial oxygen pressure ... 77 6.2 Error – Zero calibration of pressure measurement unit ... 79 6.3 Internal error – pressure channel ... 79 6.4 Internal error – temperature ... 79 6.5 Memory full ... 79 6.6 Residual operating time – battery pack ... 79 6.7 Pressure sensor has been removed ... 79 6.8 Temperature sensor has been removed ... 80 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 7 Cleaning and maintenance ... 85 7.1 Cleaning the MPR2 ... 85 7.2 Cleaning, disinfecting and sterilising the cables and sensors ... 85 7.2.1 Cleaning ... 85 7.2.2 Disinfection... 85 7.2.3 Sterilisation... 85 7.3 Cleaning the mains adapter ... 85 8 Inspections and measurement related checks ... 86 8.1 8.2 8.3

General aspects ... 86 Safety-related check ... 86 Measurement-related check-up ... 86

9 Accessories ... 87 10 Electromagnetic compatibility ... 89 10.1 Electromagnetic emissions ... 89 10.2 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 Manufacturer: RAUMEDIC AG, Hermann-Staudinger-Strasse 2, 95233 Helmbrechts, Germany Page 4 of 97

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Instructions for Use RAUMEDIC MPR2 logO 14 Index ... 96 15 Enclosures ... 97

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: 2003. 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 B. 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.

Manufacturer: RAUMEDIC AG, Hermann-Staudinger-Strasse 2, 95233 Helmbrechts, Germany Page 5 of 97

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Instructions for Use RAUMEDIC MPR2 logO 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.

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The MPR2 may be operated only with the specified mains power adapter, see chapter 12.1 Technical data.

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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.

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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.

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Prior to using the MPR2, you have to be completely familiar with the operation of the system.

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The MPR2 may be used on one patient at a time only.

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No splitting into spatially separate sensors for pressure and temperature may be effected at the multipurpose port P2/T2.

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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.

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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.

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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.

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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.

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Simultaneous operation with other apparatuses connected to the patient may cause mutual influences which may have an effect on the measuring results.

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MPR2 has not been approved for use with an electrical surgical device.

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The MPR2 is not designed for operation in CT or MRT systems and must not be present in such devices.

Manufacturer: RAUMEDIC AG, Hermann-Staudinger-Strasse 2, 95233 Helmbrechts, Germany Page 6 of 97

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Instructions for Use RAUMEDIC MPR2 logO •

If and when a defibrillator is used, short-time interferences of the signal shapes and values measured may occur.

•

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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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.

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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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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.

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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.

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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.

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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.

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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.

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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.

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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).

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If sterile accessories are used, please make sure that they are marked as being sterile.

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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.

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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.

Manufacturer: RAUMEDIC AG, Hermann-Staudinger-Strasse 2, 95233 Helmbrechts, Germany Page 7 of 97

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Instructions for Use RAUMEDIC MPR2 logO •

Additional moveable multiple sockets or extension cables must not be connected up to the system.

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Apparatuses, which are not part of the system, must not be connected.

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The moveable multiple sockets have to be suitable for the load of the system.

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The moveable multiple sockets which are supplied along with the system only may be used for the supply of the devices of the system.

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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, 3.6, 3.7 and 0.

Manufacturer: RAUMEDIC AG, Hermann-Staudinger-Strasse 2, 95233 Helmbrechts, Germany Page 8 of 97

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Instructions for Use RAUMEDIC MPR2 logO 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, 2 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 Adults, children and neonatal non-outpatient cases. In the process, the operator has to observe the operating instructions for every catheter. 2.3 Contraindications The MPR2 is contra-indicated for use in MRT. 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.

Manufacturer: RAUMEDIC AG, Hermann-Staudinger-Strasse 2, 95233 Helmbrechts, Germany Page 9 of 97

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Instructions for Use RAUMEDIC MPR2 logO 2.4 Main operating functions The main operating functions of the MPR2 are: • the installation of the unit • charging of the chargeable battery • measuring in stand-alone operation • setting of alarm limits and monitoring of physiological parameters • saving of patient data • passing on the values measured to a downstream monitor • reading and acknowledging INFO messages • setting display to light or dark • 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 righthand bank of keys directly next to the display. Their current functions are shown in the appertaining monitor area.

Manufacturer: RAUMEDIC AG, Hermann-Staudinger-Strasse 2, 95233 Helmbrechts, Germany Page 10 of 97

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8 9 10 7

11

6

12

5

13

4

14

3

15

2

16

1

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 batteryoperated 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

Manufacturer: RAUMEDIC AG, Hermann-Staudinger-Strasse 2, 95233 Helmbrechts, Germany Page 11 of 97

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Instructions for Use RAUMEDIC MPR2 logO

19

20

27

21

22

26 field Figure 2: Connection

23

25

24

[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 4.1General 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)

Manufacturer: RAUMEDIC AG, Hermann-Staudinger-Strasse 2, 95233 Helmbrechts, Germany Page 12 of 97

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Instructions for Use RAUMEDIC MPR2 logO

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.

Manufacturer: RAUMEDIC AG, Hermann-Staudinger-Strasse 2, 95233 Helmbrechts, Germany Page 13 of 97

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Instructions for Use RAUMEDIC MPR2 logO 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 [17], [19], [25], [26], [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 MPR2. In this respect, please observe the instructions for use. Analogue outputs Out-1 [24] and Out-2 [20]. 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 MPR2. 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, authorised by the manufacturer, may be used. 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 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 MPR2. 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 involved in using the device about the above mentioned ESD measures. Table 2: Information and warning symbols

Manufacturer: RAUMEDIC AG, Hermann-Staudinger-Strasse 2, 95233 Helmbrechts, Germany Page 14 of 97

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Instructions for Use RAUMEDIC MPR2 logO 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 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

Manufacturer: RAUMEDIC AG, Hermann-Staudinger-Strasse 2, 95233 Helmbrechts, Germany Page 15 of 97

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Instructions for Use RAUMEDIC MPR2 logO 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 12.1 Technical data. 3.1 Invasive pressure measurement IBP 3.1.1 General aspects Applied part Type: Number: Where: Application:

type CF for pressure sensors with radiometric characteristic 5 µV / V / mmHg 2 Figure 2: Connection field, connection ports [20] and [21] 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 10. 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 again 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: Recommended accessories:

cf. chapter 12. Technical parameters (Specification) cf. chapter 10. Accessories

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. Manufacturer: zwo-400EN RAUMEDIC AG, Hermann-Staudinger-Strasse 2, 95233 Helmbrechts, Germany Rev. 7 22/10/2018 Page 16 of 97

Instructions for Use RAUMEDIC MPR2 logO •

Position the transducer at the height of the measuring location.

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Connect the patient catheter to the pressure hose.

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Adjust the transducer to zero.

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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

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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.

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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! 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.

Manufacturer: RAUMEDIC AG, Hermann-Staudinger-Strasse 2, 95233 Helmbrechts, Germany Page 17 of 97

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Instructions for Use RAUMEDIC MPR2 logO

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:

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Zeroing RAUMEDIC catheter

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Retention of zero value

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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.

Manufacturer: RAUMEDIC AG, Hermann-Staudinger-Strasse 2, 95233 Helmbrechts, Germany Page 18 of 97

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Instructions for Use RAUMEDIC MPR2 logO 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: Number: Where: Application:

type CF fibre-optical sensor 1 Figure 2: Connection field, connection ports [19] and [20] 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 10. Accessories. No splitting into spatially separate sensors for pressure and temperature may be effected at the multipurpose 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 Manufacturer: RAUMEDIC AG, Hermann-Staudinger-Strasse 2, 95233 Helmbrechts, Germany Page 19 of 97

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Instructions for Use RAUMEDIC MPR2 logO allocate the ICP2 measuring location to the invasive pressure automatically. A partial oxygen pressure measurement without the PTO cable is not possible. Designation

Definition

pO2

ST connector for partial oxygen pressure

P2/T2

Multi-purpose connector for digital memory, invasive pressure P2 and temperature T2

Table 4: Connections for the partial oxygen pressure probe The allocation of the measuring location of the channel sets its scale, alarm source and alarm limits. As the partial oxygen pressure probes are multi-purpose probes as a rule, which combine partial oxygen pressure measurement, invasive pressure measurement and temperature measurement in one catheter, the notes rendered hereto shall have to be observed as well. Specification of the pressure channels: Recommended accessories:

cf. chapter 12. Technical parameters (Specification) cf. chapter 10. Accessories

Manufacturer: RAUMEDIC AG, Hermann-Staudinger-Strasse 2, 95233 Helmbrechts, Germany Page 20 of 97

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