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Instructions for Use RAUMEDIC



MPR2 logO

Manufacturer:

zwo-400EN

RAUMEDIC AG, Hermann-Staudinger-Strasse 2, 95233 Helmbrechts, Germany

Rev. 9 2020-09-22

Page 85 of 99

Under the following conditions

•

The Datalogger has been switched on and is displayed on the start screen.

•

The Datalogger is connected with the PC; the correct USB connection is displayed.

•

Datalog software has been started up.

•

“Save data on PC2” has been selected (download).

•

Press “Start”.

the following message is displayed on the MPR2 whilst downloading data:

The user can close the message at any time by pressing ok, and can continue working, and may also start

a new measurement. 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.

This

document

for

information

only

Содержание MPR2 logO

Страница 1: ...RAUMEDIC AG Hermann Staudinger Strasse 2 95233 Helmbrechts Germany Rev 9 2020 09 22 Page 1 of 99 Instructions for Use RAUMEDIC MPR2 logO REF 095254 001 and 095254 002 Firmware version 2 10 0068 HW2 T...

Страница 2: ...of the MPR2 16 2 9 Catheter location and signal designations 16 3 Patient monitoring 17 3 1 Invasive pressure measurement IBP 17 3 1 1 General aspects 17 3 1 2 Preparation of the invasive pressure me...

Страница 3: ...m values 49 4 4 3 5 1 Setting the pO2 limiting values 50 4 4 3 5 2 Activating and deactivating pO2 alarms 50 4 4 3 6 pO2 graphics 51 4 4 3 7 pO2 trend 52 4 4 3 8 Technical alarms during partial oxygen...

Страница 4: ...ions 82 7 Cleaning and maintenance 86 7 1 Cleaning the MPR2 86 7 2 Cleaning disinfecting and sterilising the cables and sensors 86 7 2 1 Cleaning 86 7 2 2 Disinfection 86 7 2 3 Sterilisation 86 7 3 Cl...

Страница 5: ...e 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 Qui...

Страница 6: ...of the reference LED a far reaching monitoring has been ensured When the apparatus is switched on a signal is sounded which is intended to check the alarm sounding unit If the signal is not sounded th...

Страница 7: ...nsation 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 bee...

Страница 8: ...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 oxyg...

Страница 9: ...surement 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 mo...

Страница 10: ...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 acti...

Страница 11: ...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 o...

Страница 12: ...owing 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 Fla...

Страница 13: ...284027 001 may be used according to the type plate of the MPR2 Ext Bi directional digital input output The caution sign below port E indicates that only accessory parts authorised by the manufacturer...

Страница 14: ...the marking plate and the packaging label have the following significance Manufacturer Date of manufacture Reference number Serial number Consult instructions for use Keep dry Keep away from sunlight...

Страница 15: ...mitting 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 mea...

Страница 16: ...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 Perfu...

Страница 17: ...only which are listed in the overview in chapter 9 Accessories No splitting into spatially separate sensors for pressure and temperature may be effected at the multi purpose port P2 T2 Use transducers...

Страница 18: ...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...

Страница 19: ...etention of zero value Conventional zeroing 3 1 2 3 1 Zeroing RAUMEDIC catheter During their manufacture RAUMEDIC catheters are subjected to extensive measurements Based on the evaluation of these mea...

Страница 20: ...20 Application see below When a special fibre optical catheter NEUROVENT PTO made by RAUMEDIC has been fitted the MPR2 can be used to measure and display the partial oxygen pressure The pressure chann...

Страница 21: ...re 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 par...

Страница 22: ...d on the same side see 4 4 3 1 Connecting the cable to the catheter The ICP Temp cable is not suitable for the connection of the oxygen catheter because the catheter data saved to the catheter connect...

Страница 23: ...s 0 01 Celsius and thus is higher than the accuracy mentioned above The higher resolution has been provided intentionally to recognise short time changes in temperature without the necessity of having...

Страница 24: ...party system When using the analogue output it is imperative that you proceed in keeping with chapter 4 6 1 Combine analogue outputs As from 17th March 2004 the following third party systems shall be...

Страница 25: ...can be used to connect a laptop which by means of the DataView software RAUMEDIC article No 296900 001 is used for on line display of the values measured for the extended storage of the values measure...

Страница 26: ...the presence of loose parts by shaking or tipping the appliance for example If loose parts are present the appliance must not be used If the MPR2 is operated on battery pack please check the charge c...

Страница 27: ...on is indicated right next to the respective key when the key has been allocated to a function by the software of the MPR2 4 1 2 3 Data field The data field is used to display the data measured There...

Страница 28: ...t installed on your device Further you can in this view delete the patient data saved define a new patient and select the memory mode If the memory is more than 50 full the user now receives the recom...

Страница 29: ...Please observe The memory mode set has a decisive influence on the potential recording duration Only a fraction of the memory which is required for the recording of the curves and trends in short play...

Страница 30: ...on of the Del key For irretrievable erasure of the data saved press the Del delete key The successful deletion of the data is confirmed by an acoustic signal as well as a short note on the screen Afte...

Страница 31: ...ve been deleted cf chapter 4 2 2 Deleting the memory a new patient is set up automatically If the measurement is continued this measurement will be allocated to a patient automatically when the data a...

Страница 32: ...version If the memory mode displayed is okay no other selection needs to be done If you want to continue with the displayed memory mode press the Menu key first of all The works settings are Trend cur...

Страница 33: ...s omitted 4 2 5 No storage As an alternative to the memory modes Short play SP and Long play LP from firmware version 2 00 0053 there is an option of selected a third memory mode No storage The advant...

Страница 34: ...ly deleted The deletion process lasts for a short period After data deletion alarm limit selection is carried out Specification of the site of measurement and the possibility of zeroing in case a pres...

Страница 35: ...n View last measurement Confirm with OK This function is only available if data are stored on the device Software version Confirm the selected Function with OK This function is only available if data...

Страница 36: ...ting of this channel by cable into spatially separated units is impermissible as the measuring transducers of the multi purpose channel are not galvanically separated However a single channel pressure...

Страница 37: ...Observe chapter 3 1 Invasive pressure measurement IBP Keep the connection cable ready prior to connecting the pressure transducer Use approved accessories only Observe the instructions for use of the...

Страница 38: ...cation Use the arrow keys to select the requested measuring location and then acknowledge by pressing OK Display of the selected measuring location In the next step the pressure sensor has to be zeroe...

Страница 39: ...ether the pressure signal is to be switched to one of the two analogue outputs whether you want to change the settings of the limiting alarm values and whether the limiting value monitor of the select...

Страница 40: ...displayed Limiting values for ICP Alarm active not active for ICP Limiting values for ICPA Alarm active not active for ICPA Limiting values for CPP Alarm active not active for CPP The settings rendere...

Страница 41: ...et the limiting values to extreme values which could render the alarm system useless 4 4 2 2 1 Changing the limiting value Increasing the lower limiting value Keep the LL key pressed until the request...

Страница 42: ...mbine analogue outputs The MPR2 has two analogue outputs The analogue outputs can be used to index two random pressure signals to a third party system Pressure signals could be two random pressures bu...

Страница 43: ...re thus activated as well Set alarm limits to a maximum of 350 mmHg on third party systems if monitoring is required 4 4 2 4 Invasive pressure measurement Graphics In order to skip to the graphics scr...

Страница 44: ...l times subsequently you can set a higher resolution for the time range of your choice Six time ranges are available width of the time axis in the trend graphics which you can switch over by using the...

Страница 45: ...he correct connection of the catheter connector and the cable connector mechanical coding colour coding Please observe that a wrong combination of catheter and connector with the catheter data will le...

Страница 46: ...miting alarm values have been selected the measurement is started immediately when this setting mode is left There is no query for the measuring location of the invasive pressure neither will the cath...

Страница 47: ...ntervals has a distinct influence on the achievable mobile time when the MPR2 is operated on battery pack Step 6 After acknowledgement of the selected measuring interval this is acknowledged by pressi...

Страница 48: ...window to set the limiting alarm values Subsequently press the Menu key Step 2 Select the option in the menu Acknowledge the selection by pressing OK The settings are accepted with the second OK Step...

Страница 49: ...e measurement has been switched off 4 4 3 5 pO2 limiting alarm values The right hand column of the display holds the navigation field in which you can use the soft keys to carry out further adjustment...

Страница 50: ...d Only now will the settings be active You will now access the overview of the measured values The new limiting values will be displayed provided Yes has been activated for the parameter Active 4 4 3...

Страница 51: ...r recording speeds are available 1 5 10 und 30 mm s Reduce recording speed Numeric display measured value pO2 Recording speed Set marker Use the key or to switch over the plotting speed 30 mm s corres...

Страница 52: ...ral times subsequently you can set a higher resolution for the time range of your choice Six time ranges are available width of the time axis in the trend graphics which you can switch over by using t...

Страница 53: ...ing error messages may be generated if there is a faulty or defective T2 temperature measurement Measuring location Display of the parameter in window 1 Error messages after the INFO key has been pres...

Страница 54: ...ensors port T1 temperature sensors made by Exacon or RAUMEDIC multi parameter catheters with integrated temperature measurements port P2 T2 multi purpose port to be used for the connection of a PTO ca...

Страница 55: ...been allocated to the temperature input will display the numerical value of the temperature measured For the settings of the limiting alarm values the settings mode is active first which you have sele...

Страница 56: ...et alarm limits and whether the limiting value monitor of the selected measuring value is to be active or not Proceed correspondingly if you want to change the settings for temperature T2 Do not set t...

Страница 57: ...s A graphical display for the temperature is not available in the graphics screen The temperature is displayed in the footer of the graphics screen in the form of a numerical value cf chapter 4 4 4 Tr...

Страница 58: ...ess the Shift key and thus change the allocation of the F keys the parameters available for the F keys are displayed Step 2 Select the F key parameters which you want to select or deselect as graphics...

Страница 59: ...Step 3 Carry out the zero calibration at the pressure input of the third party system Press the OK key when the zero calibration has been completed successfully Step 4 Check whether the third party s...

Страница 60: ...well as the pressure input of the third party system These errors sum up If you want to link the analogue output Out2 please proceed as with Out1 Specification of the temperature measurement cf chapt...

Страница 61: ...measurement at the pressure inputs of the external system Press the OK key once the null measurement has successfully completed for both pressure inputs Step 4 A control signal of 20 mmHg is output on...

Страница 62: ...f the temperature channels in T1 T2 Other information on the pO2 functions can be retrieved by pressing the key F key pO2 Press Diag F key to access appartus diagnostics Current Softwareversion Power...

Страница 63: ...owing steps 1 to 6 Step 1 Call the Device setup and press the Dis key Step 2 Use the arrow keys to access the number in Contrast Step 3 After having changed to Contrast press the Menu key Step 4 By pr...

Страница 64: ...ian Spanish French Portuguese Russian For the availability of other language versions please get in touch with the manufacturer Step 1 Call the Device setup and press the Dis key Step 2 Press the Menu...

Страница 65: ...rior to the time setting will not be displayed any more They will remain saved however Now skip to the set up screen by pressing the screen selector key several times if and when required and carry ou...

Страница 66: ...o navigate in the date field Step 6 Press the Menu key to set the date Step 7 By pressing the or key the year month and day can be set Press the ESC key to return to the previous step Complete your se...

Страница 67: ...this case Automatic has been set as the works settings have not been changed yet In order to change the setting press the Menu key The available settings will be rendered in the pull down menu The arr...

Страница 68: ...overview screen and press the Shift F5 key key symbol A pop up window will render information on the active key lock Button block active to unblock button press F5 and hold This note will disappear ag...

Страница 69: ...f average priority CPP Temperature Technical alarms with the exception of severe technical alarms Sensor alarms The appliance releases optical and acoustical alarms according to the alarm priority In...

Страница 70: ...a reminder signal In case of global AUDIO OFF the reminder signal releases a beep of 0 5 sec every 5 minutes AUDIO OFF can be used even when the key lock has been switched on Global AUDIO OFF however...

Страница 71: ...ed to the measuring signal of the pressure sensor and the amplitude is then evaluated Under the highly unlikely assumption that at the measuring location of ART with relatively high physiological pres...

Страница 72: ...P 0 30 Yes 20 400 1 Pressure ICP1 ICPA 0 20 No 0 400 1 Pressure ICP2 ICP 0 30 Yes 20 400 1 Pressure ICP2 ICPA 0 20 No 0 400 1 Pressure ICP1 2 CPP 50 100 Yes 0 400 1 Pressure GP1 SYS 100 180 Yes 20 400...

Страница 73: ...ded into alarms which indicate conditions under which a correct operation of the apparatus is no longer ensured or where this fact has to be expected respectively and into those alarms in which measur...

Страница 74: ...ority will be released 5 pO2 sensor error In screen 4 the following further pO2 sensor catheter data are displayed under Diagnosis pO2 Remaining cycles LOT Expiry date Remaining running time In contra...

Страница 75: ...ule off yellow Sensor Module approx 30 sec break medium priority 3 off yellow value flashes approx 20 sec break high priority red red value flashes approx 6 sec break Table 7 Alarm conditions 1 Cf Tab...

Страница 76: ...a deep discharging protection system Approximately half an hour before the apparatus is switched off automatically an acoustic alarm is sounded If the apparatus is not switched off at the end of the...

Страница 77: ...nd that the charging current has to be reduced at an ambient temperature of over 35 Celsius and that the charging time thus increases If the operating period of the battery is too low after this proce...

Страница 78: ...ery is adequately charged The mains power adapter is connected and charging is taking place Sufficient free storage is available If not then the measurement data on the device should be stored to a PC...

Страница 79: ...rking properly and pO2 measurement is activated a green blinking light at the cable end catheter side must be visible in dark environment ST Connector Connector pO2 at MPR2 is defect Change MPR2 MPR2...

Страница 80: ...ain subject the apparatus to an inspection 6 4 Internal error temperature Internal defect in temperature channel TNo Remove sensor and use other channel if needs be TNo stands for temperature channel...

Страница 81: ...essure is not working correctly Note It is imperative to note down the error number before switching the device off The most probable cause is a fault in the power supply of the device If the error is...

Страница 82: ...most probably a sensor defect Please check this and replace the sensor if necessary The pressure sensor P2 was removed Confirm this with OK If you haven t removed the sensor the cause is most probabl...

Страница 83: ...another catheter Use another catheter Fault T12 Internal error in the O2 channel The accuracy of the measured value cannot be ensured anymore Error in the reference measurement similar to the interna...

Страница 84: ...an accuracy ranging from 0 5 mmHg to 0 3 mmHg Please check the cable and catheter Fault T22 The partial oxygen pressure cannot be determined An error has arisen in the communication with the oxygen mo...

Страница 85: ...alog software has been started up Save data on PC2 has been selected download Press Start the following message is displayed on the MPR2 whilst downloading data The user can close the message at any t...

Страница 86: ...can be re used Please observe the recommendations below to avoid damage or functional impairment 7 2 1 Cleaning Use a moist cloth to wipe off If and when necessary add conventional non alcohol soap o...

Страница 87: ...provide you with the option of having the necessary checks carried out by RAUMEDIC These checks may only be carried out by appropriately qualified specialist personnel suitable training knowledge and...

Страница 88: ...283959 002 Table Stand DATALOGGER 094858 001 Cable DATALOGGER GE MARQUETTE length 2 00 m 094868 002 Cable DATALOGGER Philips HP length 2 00 m 094878 002 Cable DATALOGGER Siemens Draeger Infinity lengt...

Страница 89: ...25 37 C 0 2 K 37 39 C 0 1 K 39 45 C 0 2 K The catheter is placed in the water and dimmed during the tests 10 1 2 General information Use of this equipment adjacent to or stacked with other equipment s...

Страница 90: ...2700 MHz 1 kHz AM 80 3 V m at 2 Hz Immunity to proximity fields from RF wireless communications equipment according IEC 61000 4 3 385 MHz Pulse modulation 18 Hz 27 V m 450 MHz FM 5Hz deviation 1 kHz...

Страница 91: ...ssary configuration Interference effects may arise from other devices even if the other devices conform to the CISPR emission requirements If the amplitude of the physiological signal from the patient...

Страница 92: ...uter conductor outer conductor 2 kV voltage outer conductor earth The quality of the supply voltage should correspond to that of a typical commercial or hospital environment Voltage drops short tempor...

Страница 93: ...han the conformity level at all frequencies as demonstrated by an on sitea investigation b Interference is possible in the area surrounding devices carrying the following symbol At 80 MHz and 800 MHz...

Страница 94: ...rated power W Safe distance dependent on emitter frequency m 150 kHz to 80 MHz d 1 17 P1 2 80 MHz to 800 MHz d 1 17 P1 2 800 MHz to 2 5 GHz d 2 33 P1 2 0 01 0 12 0 12 0 24 0 1 0 37 0 37 0 74 1 1 17 1...

Страница 95: ...of defined value approx 70 mmHg is transferred to the measuring signal of the pressure sensor and the amplitude is then evaluated Under the highly unlikely assumption that at the measuring location of...

Страница 96: ...B A typical 60 dB A 1 m in stand holder Display black white LCD 320 x 240 pixel 1 4 VGA 74 x 97 mm Trend display optional 4 min 8 min 20 min 40 min 80 min or 4 h Alarm limits to be selected by menu La...

Страница 97: ...for which the use of the 284027 002 mains adapter is specified the permissible range is 620 to 1050 hPa 12 Environment and disposal All components of the MPR2 inclusive of its packaging have been sele...

Страница 98: ...3 Invasive blood pressure measurement IBP 17 invasive pressure measurement settings 39 K Key lock 68 L LCD background illumination 69 M Maintenance Cables 86 Cleaning of the monitor 86 Measurement rel...

Страница 99: ...p no 0038 Name of the conformity group RAUMEDIC MPR2 logO DATALOGGER Class IIb are developed produced tested and sold in accordance with the requirements of EC directive 93 42 EEC Appendix I The EC co...

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