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

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Summary of Contents for RAUMEDIC MPR2 logO

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

    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 Manufacturer: zwo-400EN RAUMEDIC AG, Hermann-Staudinger-Strasse 2, 95233 Helmbrechts, Germany Rev. 9 2020-09-22 Page 2 of 99...
  • Page 3 Saving the alarm settings ......................73 4.9.4 Technical alarms ........................73 4.9.4.1 Apparatus alarms ......................73 4.9.4.2 Sensor alarms ........................74 4.9.5 Summarisation ........................75 Manufacturer: zwo-400EN RAUMEDIC AG, Hermann-Staudinger-Strasse 2, 95233 Helmbrechts, Germany Rev. 9 2020-09-22 Page 3 of 99...
  • Page 4 11.2.3 Atmospheric pressure ......................97 12 Environment and disposal ........................97 13 Liability and warranty .......................... 97 14 Index ..............................98 15 Enclosures ............................99 Manufacturer: zwo-400EN RAUMEDIC AG, Hermann-Staudinger-Strasse 2, 95233 Helmbrechts, Germany Rev. 9 2020-09-22 Page 4 of 99...
  • Page 5: General Notes

    Battery-operated patient monitoring unit for the functions of partial oxygen pressure, invasive pressure and temperature General notes The MPR2 logO has received the mark in compliance with the European Directive 93/42/EEC, and 0123 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.
  • Page 6: Safety-Related Information

    Changes and modifications of the unit are not permitted. The MPR2 logO (hereinafter referred to as MPR2 for short) may be operated by qualified staff only. • The MPR2 may be operated only with the specified mains power adapter, see chapter 11.1 Technical •...
  • Page 7 Observe the instructions for the installer on how to set up the system in an ideal way. Please also read chapters 3.4, 3.5 and 3.6. Manufacturer: zwo-400EN RAUMEDIC AG, Hermann-Staudinger-Strasse 2, 95233 Helmbrechts, Germany Rev. 9 2020-09-22 Page 7 of 99...
  • Page 8: Description Of The Device

    (T, two channels). Invasive pressure measurement, oxygen partial pressure measurement and temperature measurement are significant performance characteristics of the unit. These parameters are determined by using RAUMEDIC catheters for single-channel ICP measurement or with RAUMEDIC multi-parameter catheters for combined measurement of ICP and temperature. In addition, external transducers may also be used for the invasive pressure measurement.
  • Page 9: Contraindications

    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. Manufacturer: zwo-400EN RAUMEDIC AG, Hermann-Staudinger-Strasse 2, 95233 Helmbrechts, Germany Rev. 9 2020-09-22 Page 9 of 99...
  • Page 10 Display for alarms with high priority (flashing red LED) or average priority (flashing yellow LED). Display [9] to Soft keys, also referred to as F keys. [16] [17] Connection field Table 1: Keys and functions Manufacturer: zwo-400EN RAUMEDIC AG, Hermann-Staudinger-Strasse 2, 95233 Helmbrechts, Germany Rev. 9 2020-09-22 Page 10 of 99...
  • Page 11 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: zwo-400EN RAUMEDIC AG, Hermann-Staudinger-Strasse 2, 95233 Helmbrechts, Germany Rev. 9 2020-09-22 Page 11 of 99...
  • Page 12: Information And Warning Symbols

    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: zwo-400EN RAUMEDIC AG, Hermann-Staudinger-Strasse 2, 95233 Helmbrechts, Germany Rev. 9 2020-09-22 Page 12 of 99...
  • Page 13: Information And Warning Symbols On The Bottom Side And The Type Plate Of The Unit

    The caution sign above the patient connections indicates that only accessory parts authorised by the manufacturer may be connected up to the RAUMEDIC MPR2 logO DATALOGGER. In this respect, please observe the instructions for use. Analogue outputs Out-1 [26] and Out-2 [22].
  • Page 14 Please observe the disposal instructions. Do not put old units into the garbage. The device meets the essential Requirements of the European Directive 93/42/EEC Manufacturer: zwo-400EN RAUMEDIC AG, Hermann-Staudinger-Strasse 2, 95233 Helmbrechts, Germany Rev. 9 2020-09-22 Page 14 of 99...
  • Page 15: Abbreviations

    Nand Flash File System NiMH Nickel Metal Hydride Phiboard (optoelectronic oxygen sensor module) S.F.C. Single Fault Condition Serial Number Short Play memory mode Safety-related check Software Manufacturer: zwo-400EN RAUMEDIC AG, Hermann-Staudinger-Strasse 2, 95233 Helmbrechts, Germany Rev. 9 2020-09-22 Page 15 of 99...
  • Page 16: Code Designations On The Connection Ports Of The Mpr2

    Median pressure D2 Median pressure D3 Upper limiting value pO2, ptiO2 Partial oxygen pressure Systolic pressure Temperature T1 Temperature T2 Lower limiting value Central venal pressure Manufacturer: zwo-400EN RAUMEDIC AG, Hermann-Staudinger-Strasse 2, 95233 Helmbrechts, Germany Rev. 9 2020-09-22 Page 16 of 99...
  • Page 17: Patient Monitoring

    The allocation of the measuring location of the pressure channel sets its scale, alarm source and alarm limits. Specification of the pressure channels: cf. chapter 11 Technical parameters (Specification) Recommended accessories: cf. chapter 9 Accessories Manufacturer: zwo-400EN RAUMEDIC AG, Hermann-Staudinger-Strasse 2, 95233 Helmbrechts, Germany Rev. 9 2020-09-22 Page 17 of 99...
  • Page 18: Preparation Of The Invasive Pressure Measurement

    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! Manufacturer: zwo-400EN RAUMEDIC AG, Hermann-Staudinger-Strasse 2, 95233 Helmbrechts, Germany Rev.
  • Page 19: Zero Calibration

    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.
  • Page 20: Retention Of Zero Value

    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.
  • Page 21 Specification of the pressure channels: cf. chapter 11 Technical parameters (Specification) Recommended accessories: cf. chapter 9 Accessories Manufacturer: zwo-400EN RAUMEDIC AG, Hermann-Staudinger-Strasse 2, 95233 Helmbrechts, Germany Rev. 9 2020-09-22 Page 21 of 99...
  • Page 22: Preparation Of The Catheter

    During the zeroing of the pressure transducer, please observe the instructions for use of the catheter. Select the “Zeroing RAUMEDIC catheter” option only, if such a catheter has been connected, and the instructions for use explicitly prescribe this zeroing process.
  • Page 23: Measurement Of The Body Temperature

    In case of a defective sensor (short circuit or cable cut) no value is displayed, instead the display Sensor? starts flashing. Manufacturer: zwo-400EN RAUMEDIC AG, Hermann-Staudinger-Strasse 2, 95233 Helmbrechts, Germany Rev. 9 2020-09-22 Page 23 of 99...
  • Page 24: Cleaning, Disinfecting And Sterilising The Temperature Sensor

    For information on placing and handling the temperature sensors, please refer to the respective instructions for use. 3.3.2 Cleaning, disinfecting and sterilising the temperature sensor RAUMEDIC multi-parameter catheters (precision pressure catheters with additional temperature measurement) are sterile products and are intended for single use only. Analogue outputs Type:...
  • Page 25: Pc Interface

    Use approved accessories only. By means of the USB cable (RAUMEDIC article No. 283949-001), this USB interface can be used to connect a laptop, which by means of the DataView software (RAUMEDIC article No. 296900-001) is used •...
  • Page 26: Operation Of The Mpr2

    After the settings have been made, leave the start screen and skip to the overview screen which is marked with the symbol in the information field of the display. No. of the Screen Manufacturer: zwo-400EN RAUMEDIC AG, Hermann-Staudinger-Strasse 2, 95233 Helmbrechts, Germany Rev. 9 2020-09-22 Page 26 of 99...
  • Page 27: Information Field

    In base condition (i.e. after the apparatus has been switched on), the start screen will always be displayed (cf. Fig. 8). By repeated actuation of the screen forward key, you skip between the individual screens: Overview Overview Overview Overview Manufacturer: zwo-400EN RAUMEDIC AG, Hermann-Staudinger-Strasse 2, 95233 Helmbrechts, Germany Rev. 9 2020-09-22 Page 27 of 99...
  • Page 28: Start Screen

    This recommendation can be ignored, which however has the consequence that the condition "Memory full" will more than likely be reached instead. Software version Manufacturer: zwo-400EN RAUMEDIC AG, Hermann-Staudinger-Strasse 2, 95233 Helmbrechts, Germany Rev. 9 2020-09-22 Page 28 of 99...
  • Page 29: General Notes On The Key Functions

    Depending on the memory display you can now decide whether all previously saved patient data are to be erased or not. You should decide in favour of erasing if you want to ensure a maximum of recording time. Software version Manufacturer: zwo-400EN RAUMEDIC AG, Hermann-Staudinger-Strasse 2, 95233 Helmbrechts, Germany Rev. 9 2020-09-22 Page 29 of 99...
  • Page 30 As the available data have been erased, you cannot continue with the previous patient in this case, instead a new patient documentation is opened automatically. At this point you can only select the memory mode. Manufacturer: zwo-400EN RAUMEDIC AG, Hermann-Staudinger-Strasse 2, 95233 Helmbrechts, Germany Rev. 9 2020-09-22 Page 30 of 99...
  • Page 31: Open A New Patient Documentation

    Internally the patient IDs are counted further. The last five digits of the internal patient IDs only are displayed. An ID 0 is suppressed. Manufacturer: zwo-400EN RAUMEDIC AG, Hermann-Staudinger-Strasse 2, 95233 Helmbrechts, Germany Rev. 9 2020-09-22 Page 31 of 99...
  • Page 32: Selecting The Memory Mode

    OK. If you want to discard your selection, press the ESC key to return to the previous step. Software version Manufacturer: zwo-400EN RAUMEDIC AG, Hermann-Staudinger-Strasse 2, 95233 Helmbrechts, Germany Rev. 9 2020-09-22 Page 32 of 99...
  • Page 33: No Storage

    Confirm with OK. The memory mode "No storing" is indicated in the status line by the symbol Manufacturer: zwo-400EN RAUMEDIC AG, Hermann-Staudinger-Strasse 2, 95233 Helmbrechts, Germany Rev. 9 2020-09-22 Page 33 of 99...
  • Page 34 Even in memory mode “No storage“ trend display is indicated in the status line by the symbol for up to 8 hours is possible. Beyond this period, older data are overwritten. Manufacturer: zwo-400EN RAUMEDIC AG, Hermann-Staudinger-Strasse 2, 95233 Helmbrechts, Germany Rev. 9 2020-09-22 Page 34 of 99...
  • Page 35: View Last Measurement

    In addition, the alarm LED flashes yellow in this operating mode, so that the user recognizes that the device is not in monitoring mode. Manufacturer: zwo-400EN RAUMEDIC AG, Hermann-Staudinger-Strasse 2, 95233 Helmbrechts, Germany Rev. 9 2020-09-22 Page 35 of 99...
  • Page 36: Selecting The Limiting Alarm Values

    (applies for invasive pressure) or the limiting alarm values have to be set (applies for invasive pressure, pO2 and temperature). Manufacturer: zwo-400EN RAUMEDIC AG, Hermann-Staudinger-Strasse 2, 95233 Helmbrechts, Germany Rev. 9 2020-09-22 Page 36 of 99...
  • Page 37: Operating Instructions - Connection Cable

    If you want to begin with the selection of the measuring location, press the Menu key. The pull-down menu with the overview of the measuring locations available will open. Please keep in mind that you can allocate a measuring location once only. Manufacturer: zwo-400EN RAUMEDIC AG, Hermann-Staudinger-Strasse 2, 95233 Helmbrechts, Germany Rev. 9 2020-09-22 Page 37 of 99...
  • Page 38 Press the Menu key and select the zeroing procedure recommended for the pressure sensor. The default setting in this menu is “Zeroing RAUMEDIC catheter”. Prior to zeroing, please ensure that the pressure sensor is subjected to the pressure conditions described in the instructions for use.
  • Page 39: Settings Of Invasive Pressure Measurement

    If only one intra-cranial pressure (ICP1 or ICP2) is available, the CPP is calculated from ART and ICP1 or ICP2, depending on which measuring location has been allocated. Manufacturer: zwo-400EN RAUMEDIC AG, Hermann-Staudinger-Strasse 2, 95233 Helmbrechts, Germany Rev. 9 2020-09-22 Page 39 of 99...
  • Page 40 4.9.2 Factory settings. In order to change the settings, use the arrow keys to navigate to the requested parameter and then press the Menu key. Manufacturer: zwo-400EN RAUMEDIC AG, Hermann-Staudinger-Strasse 2, 95233 Helmbrechts, Germany Rev. 9 2020-09-22 Page 40 of 99...
  • Page 41: Changing The Limiting Alarm Value Settings Of Invasive Pressure Measurement

    If you want to change other settings or repeat a setting, press the ICP1 key or the key of another measuring location again. Manufacturer: zwo-400EN RAUMEDIC AG, Hermann-Staudinger-Strasse 2, 95233 Helmbrechts, Germany Rev. 9 2020-09-22 Page 41 of 99...
  • Page 42: Activating And Deactivating The Alarms

    Zero the third-party system. You have 180 seconds time to press the next button. In case of a timeout the system changes to step 1. Manufacturer: zwo-400EN RAUMEDIC AG, Hermann-Staudinger-Strasse 2, 95233 Helmbrechts, Germany Rev. 9 2020-09-22 Page 42 of 99...
  • Page 43: Invasive Pressure Measurement - Graphics

    Press Start to continue recording process Use the key to freeze the current curve, which is released by pressing the key Manufacturer: zwo-400EN RAUMEDIC AG, Hermann-Staudinger-Strasse 2, 95233 Helmbrechts, Germany Rev. 9 2020-09-22 Page 43 of 99...
  • Page 44: Trend

    Finer temporal resolution Coarser temporal resolution Coarser backward navigation Finer backward navigation Finer forward navigation Coarser forward navigation Manufacturer: zwo-400EN RAUMEDIC AG, Hermann-Staudinger-Strasse 2, 95233 Helmbrechts, Germany Rev. 9 2020-09-22 Page 44 of 99...
  • Page 45: Measuring The Cpp

    Please observe chapter 3.2 Measurement of the partial oxygen pressure. Use approved accessories only. Please note that when RAUMEDIC PTO catheters are used for the measurement of the partial oxygen pressure (pO2), the intra-cranial pressure (ICP) and the temperature (T), the FOC, (article No.
  • Page 46: Connecting The Cable To The Mpr2

    If the pO2 key is pressed, other settings can be carried out. Manufacturer: zwo-400EN RAUMEDIC AG, Hermann-Staudinger-Strasse 2, 95233 Helmbrechts, Germany Rev. 9 2020-09-22 Page 46 of 99...
  • Page 47 Please keep in mind that the partial oxygen pressure is a parameter which changes slowly. Manufacturer: zwo-400EN RAUMEDIC AG, Hermann-Staudinger-Strasse 2, 95233 Helmbrechts, Germany Rev. 9 2020-09-22 Page 47 of 99...
  • Page 48: Switching Off Individual Measurement Functions During Po2 Measurement

    OK is has been switched off. navigate to "Use channel". Then pressed for the second time. press the menu key. Manufacturer: zwo-400EN RAUMEDIC AG, Hermann-Staudinger-Strasse 2, 95233 Helmbrechts, Germany Rev. 9 2020-09-22 Page 48 of 99...
  • Page 49: Switching Off Pressure Measurement Icp2

    Do not set the limiting values to extreme figures which could render the alarm system useless. Manufacturer: zwo-400EN RAUMEDIC AG, Hermann-Staudinger-Strasse 2, 95233 Helmbrechts, Germany Rev. 9 2020-09-22 Page 49 of 99...
  • Page 50: Setting The Po2 Limiting Values

    Subsequently Press the OK key to leave the which want change. press the OK key. screen. Subsequently press the Menu key. Manufacturer: zwo-400EN RAUMEDIC AG, Hermann-Staudinger-Strasse 2, 95233 Helmbrechts, Germany Rev. 9 2020-09-22 Page 50 of 99...
  • Page 51: Po2 Graphics

    Press Start to continue recording process Use the key to freeze the current curve, which is released by pressing the key Manufacturer: zwo-400EN RAUMEDIC AG, Hermann-Staudinger-Strasse 2, 95233 Helmbrechts, Germany Rev. 9 2020-09-22 Page 51 of 99...
  • Page 52: Po2 Trend

    Finer temporal resolution Coarser temporal resolution Coarser backward navigation Finer backward navigation Finer forward navigation Coarser forward navigation Manufacturer: zwo-400EN RAUMEDIC AG, Hermann-Staudinger-Strasse 2, 95233 Helmbrechts, Germany Rev. 9 2020-09-22 Page 52 of 99...
  • Page 53: Technical Alarms During Partial Oxygen Pressure Measurement

    The additional display error caused by the fixed temperature compensation at 37 °Celsius is shown in the following diagram for various clinically relevant partial oxygen pressures. Manufacturer: zwo-400EN RAUMEDIC AG, Hermann-Staudinger-Strasse 2, 95233 Helmbrechts, Germany Rev. 9 2020-09-22 Page 53 of 99...
  • Page 54: Transducer For Temperature Measurement

    ICP-Temp separator with jack plug, (article No. 094323-001), are required when the RAUMEDIC multi-parameter catheters with temperature measurement are used. Please observe that when RAUMEDIC PTO catheters are used for temperature measurement, the PTO cable, (article No. 095624-001), is required in addition to the NEUROVENT-PTO catheter, (article No.
  • Page 55 4.9.2 Factory settings. Optical alarm T2 Other settings T1 Alarm limits Other settings T2 Alarm limits Information (on alarms, for example). Manufacturer: zwo-400EN RAUMEDIC AG, Hermann-Staudinger-Strasse 2, 95233 Helmbrechts, Germany Rev. 9 2020-09-22 Page 55 of 99...
  • Page 56: Changing The Temperature Settings

    If you want to change other settings or repeat a setting, press the key T1 or T2, if another temperature sensor has been connected. Manufacturer: zwo-400EN RAUMEDIC AG, Hermann-Staudinger-Strasse 2, 95233 Helmbrechts, Germany Rev. 9 2020-09-22 Page 56 of 99...
  • Page 57: Activating And Deactivating The Temperature Alarms

    Six time ranges are available (width of the time axis in the trend graphics) which you can switch over by using the key Finer temporal resolution Coarser temporal resolution Coarser backward navigation Finer backward navigation Finer forward navigation Coarser forward navigation Manufacturer: zwo-400EN RAUMEDIC AG, Hermann-Staudinger-Strasse 2, 95233 Helmbrechts, Germany Rev. 9 2020-09-22 Page 57 of 99...
  • Page 58: Configuring The Graphics Display

    Establish the cable connection between Out-1 or Out-2 of the MPR2 and pressure measurement • input of the third-party system. Manufacturer: zwo-400EN RAUMEDIC AG, Hermann-Staudinger-Strasse 2, 95233 Helmbrechts, Germany Rev. 9 2020-09-22 Page 58 of 99...
  • Page 59 The zero point of the pressure sensor is not lost by this action. Manufacturer: zwo-400EN RAUMEDIC AG, Hermann-Staudinger-Strasse 2, 95233 Helmbrechts, Germany Rev. 9 2020-09-22 Page 59 of 99...
  • Page 60: Special Function Outpo

    ICP2 and pO2 are forwarded in a procedure, with pO2 routed to Out1 and ICP2 to Out2. Here the control signal equals 20 mmHg. Manufacturer: zwo-400EN RAUMEDIC AG, Hermann-Staudinger-Strasse 2, 95233 Helmbrechts, Germany Rev. 9 2020-09-22 Page 60 of 99...
  • Page 61 4, enter device setup (figure 4). ICP2 via Out2. Check the displays on the external Exit screen 4 by pressing the next system and confirm by pressing Manufacturer: zwo-400EN RAUMEDIC AG, Hermann-Staudinger-Strasse 2, 95233 Helmbrechts, Germany Rev. 9 2020-09-22 Page 61 of 99...
  • Page 62: Device Diagnostics

    Devices of earlier delivery date can have a lower version of the software. With respect to the firmware, the MPR2 can be updated. Please get in touch with the manufacturer to check the availability of a new firmware version Manufacturer: zwo-400EN RAUMEDIC AG, Hermann-Staudinger-Strasse 2, 95233 Helmbrechts, Germany Rev. 9 2020-09-22 Page 62 of 99...
  • Page 63: Setting The Lcd Contrast

    ESC to cancel the modification.) displayed. changed. Press the ESC key to Accept the new value by pressing return to the previous step. Manufacturer: zwo-400EN RAUMEDIC AG, Hermann-Staudinger-Strasse 2, 95233 Helmbrechts, Germany Rev. 9 2020-09-22 Page 63 of 99...
  • Page 64: Setting The Language Version

    Step 4: Step 5: Step 6: Press the OK key. Acknowledge the newly selected language version language by pressing OK. selected is active. Manufacturer: zwo-400EN RAUMEDIC AG, Hermann-Staudinger-Strasse 2, 95233 Helmbrechts, Germany Rev. 9 2020-09-22 Page 64 of 99...
  • Page 65: Setting Date And Time

    Press the ESC key to return to the accepted when the windows is previous step. Complete your closed by pressing OK. settings by pressing the OK key. Manufacturer: zwo-400EN RAUMEDIC AG, Hermann-Staudinger-Strasse 2, 95233 Helmbrechts, Germany Rev. 9 2020-09-22 Page 65 of 99...
  • Page 66: Setting The Date

    ESC key to return to the accepted when the windows is previous step. Complete your closed by pressing OK. settings by pressing the OK key. Manufacturer: zwo-400EN RAUMEDIC AG, Hermann-Staudinger-Strasse 2, 95233 Helmbrechts, Germany Rev. 9 2020-09-22 Page 66 of 99...
  • Page 67: Modifying The Scaling

    The arrow keys are used to change the requested settings, such Setup Subsequently close the window by pressing OK. Manufacturer: zwo-400EN RAUMEDIC AG, Hermann-Staudinger-Strasse 2, 95233 Helmbrechts, Germany Rev. 9 2020-09-22 Page 67 of 99...
  • Page 68: Key Lock

    Step 2: Step 3: Skip to the overview screen and Subsequently press the F5 key The key lock is active. press the Shift key. (key). Manufacturer: zwo-400EN RAUMEDIC AG, Hermann-Staudinger-Strasse 2, 95233 Helmbrechts, Germany Rev. 9 2020-09-22 Page 68 of 99...
  • Page 69: Switching On The Lcd Background Illumination

    If the alarm conditions continue, the alarm of high priority will continue to be signalled optically (red LED flashing). Manufacturer: zwo-400EN RAUMEDIC AG, Hermann-Staudinger-Strasse 2, 95233 Helmbrechts, Germany Rev. 9 2020-09-22 Page 69 of 99...
  • Page 70 For this reason, the user should be handling this function very knowingly. The operator settings (cf. Instruction for Use of Software DataView, Device setup MPR 1 - / MPR2 logO DATALOGGER) can be used to activate a reminder signal. In case of global AUDIO OFF, the reminder signal releases a beep of 0.5 sec.
  • Page 71: Physiological Alarms

    The apparatus automatically switches into the display mode (if no menu has been opened). AUDIO OFF only switches the acoustic signal off. The value flashes until it is outside of range. Manufacturer: zwo-400EN RAUMEDIC AG, Hermann-Staudinger-Strasse 2, 95233 Helmbrechts, Germany Rev. 9 2020-09-22 Page 71 of 99...
  • Page 72: Factory Settings

    4.9.2.2 Alarm signal inactivation The global AUDIO PAUSING has been set to a duration of 10 minutes. Manufacturer: zwo-400EN RAUMEDIC AG, Hermann-Staudinger-Strasse 2, 95233 Helmbrechts, Germany Rev. 9 2020-09-22 Page 72 of 99...
  • Page 73: Scaling

    In conjunction with the info message, this alarm behaves like a sensor alarm. If the info message is viewed, the alarm is erased, but the memory filling level indicator continues to flash. Manufacturer: zwo-400EN RAUMEDIC AG, Hermann-Staudinger-Strasse 2, 95233 Helmbrechts, Germany Rev. 9 2020-09-22 Page 73 of 99...
  • Page 74: Sensor Alarms

    Exceptions are the sensor alarms (5) and (6). With these sensor alarms, the alarm remains active even after the info key has been pressed. Manufacturer: zwo-400EN RAUMEDIC AG, Hermann-Staudinger-Strasse 2, 95233 Helmbrechts, Germany Rev. 9 2020-09-22 Page 74 of 99...
  • Page 75: Summarisation

    4.6.2 Device diagnostics. Please observe when verifying the alarm system that alarms of high and medium priority are tested according to the table rendered above. Manufacturer: zwo-400EN RAUMEDIC AG, Hermann-Staudinger-Strasse 2, 95233 Helmbrechts, Germany Rev. 9 2020-09-22 Page 75 of 99...
  • Page 76: Power Supply

    If the MPR2 is to be operated on mains power, mains adapter, which belongs to the scope of delivery, shall be used only (RAUMEDIC Art. No. 284007-002 or 284027-001, corresponding with the type plate). The mains adapter is not protected against moisture, and thus it must not get into contact with liquids.
  • Page 77: Battery Maintenance

    The use of energy sources not explicitly approved of for this apparatus may lead to damage and hazards. Manufacturer: zwo-400EN RAUMEDIC AG, Hermann-Staudinger-Strasse 2, 95233 Helmbrechts, Germany Rev. 9 2020-09-22 Page 77 of 99...
  • Page 78: Troubleshooting

    Connect the cable PTO to the catheter. Gold dots on connected to the the cable connector have to be aligned the gold dots catheter, but rotated by of the catheter connector 180 ° Manufacturer: zwo-400EN RAUMEDIC AG, Hermann-Staudinger-Strasse 2, 95233 Helmbrechts, Germany Rev. 9 2020-09-22 Page 78 of 99...
  • Page 79 Check amplitude at MPR2. Normal value > 375. at MPR2 Clean optical connector at the catheter. Follow additional references. pO2 deactivated at Change device settings. Activate pO2 channel. MPR2 Manufacturer: zwo-400EN RAUMEDIC AG, Hermann-Staudinger-Strasse 2, 95233 Helmbrechts, Germany Rev. 9 2020-09-22 Page 79 of 99...
  • Page 80: Error - Zero Calibration Of Pressure Measurement Unit

    Please check this and swap the sensor, if needs be! PNo. stands for pressure channel P1 or P2, depending on which pressure channel is affected. Manufacturer: zwo-400EN RAUMEDIC AG, Hermann-Staudinger-Strasse 2, 95233 Helmbrechts, Germany Rev. 9 2020-09-22 Page 80 of 99...
  • Page 81: Temperature Sensor Has Been Removed

    The MPR2 must not be operated when the battery-pack compartment is open! Prior to closing the battery-pack compartment, check the seal. If it is damaged, it has to be replaced by a new one. Manufacturer: zwo-400EN RAUMEDIC AG, Hermann-Staudinger-Strasse 2, 95233 Helmbrechts, Germany Rev. 9 2020-09-22 Page 81 of 99...
  • Page 82: Reaction To Fault Messages And Indications

    A defect with the data saving has arisen, it is no longer possible to continue recording. Please switch the equipment off and then on again. Erase memory completely. Manufacturer: zwo-400EN RAUMEDIC AG, Hermann-Staudinger-Strasse 2, 95233 Helmbrechts, Germany Rev. 9 2020-09-22 Page 82 of 99...
  • Page 83 The partial oxygen pressure cannot be measured. Catheter broken; no optical Check catheter for correct connection. Possibly the connection or dirt in the optical catheter has broken. coupling. Manufacturer: zwo-400EN RAUMEDIC AG, Hermann-Staudinger-Strasse 2, 95233 Helmbrechts, Germany Rev. 9 2020-09-22 Page 83 of 99...
  • Page 84 OK. The purpose of this message is to call attention of the user to a potential operating error (see 4.4.3 Partial oxygen pressure sensor). • Messages on the MPR2 when saving data to the PC Manufacturer: zwo-400EN RAUMEDIC AG, Hermann-Staudinger-Strasse 2, 95233 Helmbrechts, Germany Rev. 9 2020-09-22 Page 84 of 99...
  • Page 85 In case of an interruption of the data transmission, the user cannot download the data currently saved on the MPR2 because the PC does not have the information. In this case, the process has to be repeated. Manufacturer: zwo-400EN RAUMEDIC AG, Hermann-Staudinger-Strasse 2, 95233 Helmbrechts, Germany Rev. 9 2020-09-22 Page 85 of 99...
  • Page 86: Cleaning And Maintenance

    The mains adapter is not protected against moisture, and thus it must not get into contact with liquids. If and when required at all, use a dry soft cloth to clean the mains adapter. Manufacturer: zwo-400EN RAUMEDIC AG, Hermann-Staudinger-Strasse 2, 95233 Helmbrechts, Germany Rev. 9 2020-09-22 Page 86 of 99...
  • Page 87: Safety And Measurement Related Checks

    The Medical Devices Operator Ordinance (MPBetreibV) is the source for the operator’s obligation to have a measurement check performed for medical devices that determine body temperatures (medical electronic thermometers) every two years. The MPR2 logO is a device with an electric temperature measurement function.
  • Page 88: Accessories

     Accessories Use accessories only, which have been approved by RAUMEDIC. Use of non-approved parts may lead to damage on the system or faulty measurements. Please refer to the following 2 tables for the order designation of the approved accessories: Article No.
  • Page 89: Electromagnetic Compatibility

    If the amplitude of the physiological signal from the patient lies below the minimum amplitude and/or the values given in section 11.1 Technical data, device use could lead to inaccurate results. Manufacturer: zwo-400EN RAUMEDIC AG, Hermann-Staudinger-Strasse 2, 95233 Helmbrechts, Germany Rev. 9 2020-09-22 Page 89 of 99...
  • Page 90: Electromagnetic Emissions

    0 % U for 1 Cycle at 0° 70 % U for 25/30 cycles bei 0° 0 % U for 250/300 cycles bei 0° Manufacturer: zwo-400EN RAUMEDIC AG, Hermann-Staudinger-Strasse 2, 95233 Helmbrechts, Germany Rev. 9 2020-09-22 Page 90 of 99...
  • Page 91: Manufacturer's Declaration On The Emc Requirements According To Iec 60601-1-2:2007

    IEC 61000-3-2 network, which also supplies buildings that Emission of voltage Matches all are used for living purposes. fluctuations/flicker as per IEC 61000-3-3 Manufacturer: zwo-400EN RAUMEDIC AG, Hermann-Staudinger-Strasse 2, 95233 Helmbrechts, Germany Rev. 9 2020-09-22 Page 91 of 99...
  • Page 92: Electromagnetic Immunity

    In the following table P means the transmission power of the transmitter specified by the manufacturer in watts (W) and d is the recommended distance in metres (m). Manufacturer: zwo-400EN RAUMEDIC AG, Hermann-Staudinger-Strasse 2, 95233 Helmbrechts, Germany Rev. 9 2020-09-22 Page 92 of 99...
  • Page 93 MPR2. The field strength should be less than 3 V/m in the frequency range 150 kHz to 80 MHz. Manufacturer: zwo-400EN RAUMEDIC AG, Hermann-Staudinger-Strasse 2, 95233 Helmbrechts, Germany Rev. 9 2020-09-22 Page 93 of 99...
  • Page 94 These guidelines may not be applicable in all cases. The propagation of electromagnetic waves is influenced by their absorption and reflection by buildings, objects and people. Manufacturer: zwo-400EN RAUMEDIC AG, Hermann-Staudinger-Strasse 2, 95233 Helmbrechts, Germany Rev. 9 2020-09-22 Page 94 of 99...
  • Page 95: Technical Parameters (Specification)

    < 10 % of the measured value for the partial oxygen pressure 120 mmHg to 200 mmHg (cf. 4.4.3.8 Technical alarms during partial oxygen pressure measurement) Manufacturer: zwo-400EN RAUMEDIC AG, Hermann-Staudinger-Strasse 2, 95233 Helmbrechts, Germany Rev. 9 2020-09-22 Page 95 of 99...
  • Page 96 The fuse can be obtained from the manufacturer, if necessary. Manufacturer: zwo-400EN RAUMEDIC AG, Hermann-Staudinger-Strasse 2, 95233 Helmbrechts, Germany Rev. 9 2020-09-22 Page 96 of 99...
  • Page 97: Environmental Conditions

    The customer or user shall be obligated to check the suitability for the intended purpose of application, in particular by suitable functional tests. RAUMEDIC shall assume no explicit or implied warranty, guarantee or liability for the suitability for any purpose which exceeds the description of the article in these instructions of use.
  • Page 98: Index

    Invasive blood pressure measurement IBP · 17 Transducer temperature · 54 invasive pressure measurement settings · 39 Zero calibration · 19 Key lock · 68 Manufacturer: zwo-400EN RAUMEDIC AG, Hermann-Staudinger-Strasse 2, 95233 Helmbrechts, Germany Rev. 9 2020-09-22 Page 98 of 99...
  • Page 99: Enclosures

    Adherence to the processes specified in directive 93/42/EEC is covered through the monitoring by the "notified body": TÜV SÜD Product Service Ridlerstrasse 65 80339 München Germany Identification No.: 0123 RAUMEDIC AG Manufacturer: zwo-400EN RAUMEDIC AG, Hermann-Staudinger-Strasse 2, 95233 Helmbrechts, Germany Rev. 9 2020-09-22 Page 99 of 99...

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