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Summary of Contents for PM 8030

Page 1: ... PM 8030 Airway Monitor Instructions for Use Software 6 n ...

Page 2: ...rinciple 49 Explanation of terms used 50 For Your Safety and That of Your Patients Intended Use Brief description Calibration 11 Calibrating 02 sensor 1 1 02 sensor checking linearity 13 Calibrating flow sensor 13 Cleaning flow sensor 14 Calibrating anaesthetic agent sensor 15 Operation 16 Carrying out function check 76 Selecting anaesthetic agent 18 Setting limit values 18 Displaying measured val...

Page 3: ... Safety of Medical Eiectrical Equipment are applicable for electrically po wered equipment Not for se in areas of explosion hazard This apparatus is neither approved nor certified for use in areas where combusiible or explosive gas mixtures are likely to occur Connection with other electrical equipment Nectrical connections io equipment which is not listed in these instructions for use should only...

Page 4: ... enflurane isoflurane Monitoring Airway pressure paw lnspiratory oxygen concentration FiO2 Expiratory minute volume i E lnspiratory airr remperature Concentration oi anaesthetic agent in fresh gas RS 232 C lnteriace For exchanging dara with the PM 8010 Patient Monitor software 3 2 or he PM 8020 Data Manager or for transferring data IOa PC or a printer Monitorbus lntetiace To start measurir operati...

Page 5: ...e can be selected with button j Pmean aiway temperature breathing frequency The menu guide and the alarm displays are shown in the right hand display field The menu content can be recalled using the menu buttons Q select limit values calibrate sensors ZJ select anaesthetic agent With selector knob to select or to adjust turn confirm press menu contents are selected limit values set and special war...

Page 6: ...e rear latches into the ream dots and secure at the back with knurled screwy Place on an even surface such as a monitor rack Fix PM 8030 securely Connecting sensor and pressure measuring line 0 Use sterile or disinfected sensors At the back 1 Connect 02 sensor plug 2 Connect temperature sensor plug 3 Push hose of pressure measuring line firmly onto spigot 4 connect flow sen or plug 5 Connect anaes...

Page 7: ...cap from sensor housing l Remove new sensor capsule from packaging or use disinfected sensor capsule 2 Place capsule in housing ring shaped conductor track onto contacts in housing 1 Tighten screw cap by hand Connecting 02 sensor with cap M 21 462 plug adapter M 27 964 condenser if a great deal of condensation is expected M 27 666 Unscrew the nut on the inspiratory valve Replace the sight giass wi...

Page 8: ...ensor Adapter and accessories Y piece M 30 543 Hose clip set of 10 84 04 047 Push temperature sensor into hole on the Y piece as far as it will go After replacing the Y piece align sensor vertically so that condensate will not be able to get into it Attach sensor cable to inspiratoty hose with hose clips A3 Connecting other machines via RS 232 C Interface PM 8010 Patient Monitor with data cable PM...

Page 9: ...e with screwdriver 2 Another machine can be connected with the second connection Additional earth connection e g for cardiac operations l Attach one end of the earth cable to the potential equalisation pin at the back of the machine l Connect the other end to a potential equalisation poinr in the room Connecting to power supply PM 8030 can be operated on mains voltages from 100 V to 240 V l Connec...

Page 10: ...e charge NiCd battery Press Standby button the continuous tone ceases Switch mains power back on The monitor now carries out a self test All LEDs and display elements are lit a single tone sounds Software and language versions are displayed The internal program memories are tested The alarms for monitoring are checked The self test is completed in about 30 seconds Charging NiCd battery If when the...

Page 11: ...ensor page 15 Calibrating 02 sensor aftersensorhas been replaced 15 minutes warming up time after 24 hours after 1 month carry out linearity check For use mainly with 02 concentrations up to 60 by vol calibrate with air For use with 02 concentrations up to 100 by vol and for linearity checks calibrate with 02 Calibration with air l Remove 02 sensorand expose to ambient air for 2 minutes When reque...

Page 12: ...of about 1 L min for about 2 minutes When requested by the machine after switching on or Press calibration button and select 02 sensor Display Calib Oz sensor m 100 no Continue flushing with OZ Select lOO in menu and confirm Display 02 calibration at 100 vol Display for 02 concentration CAL After about 30 seconds but no longer than 3 l 2 minutes 2 Display 02 sensor calib completed Calibration has ...

Page 13: ... and calibrate page 11 Calibrating flow sensor when sensor has been replaced after 24 hours of operation 0 Unscrew measuring connection and remove flow sensor l With flow sensor in horizontal position connector pointing downwards seal both openings in the ambient air preferably using thumb and middle finger After a request by the monitor when switching on Or 1 Press calibration button and select f...

Page 14: ...esthesia when there is a danger of contamination Only sensors which are ready for measurement can be cleaned by this method the sensor remains connected During calibration the sensor is automatically cleaned Press calibration button and select flow enspr Display Callb flow sensor yes no cleaniw Select xleaning and confirm Display Flow sensor cleaning After about 4 seconds 2 Display Flow sensor cle...

Page 15: ...eor for at least 10 seconds Do not use 02 flush for flushing After switching on and after request by machine Or 1 2 3 2 Press calibration button and select A Vap sensor Display Calib A Vap sensor Ye II0 Select yes and confirm Display A Vap sensor flushed with Oz air Continue with anaesthetic vaporiser at 0 and 02 flow of about 10 Umin 3 Confirm press knob 2 Display A Vap sensor calib 4 A Vap displ...

Page 16: ...e displayed All LEDs and display elements are lit a single tone sounds Display Drtiger PM 8030 The alarms for monitoring are tested The self test is completed after about 30 seconds For operation with Monitorbus 0 Switch ventilator to IPPV 1 The green LED goes out PM 8030 is in measuring mode Checking 02 measurement 2 0 3 l Press Standby button green LED goes out measuring mode Remove 02 sensor fr...

Page 17: ...d 0 Release hose 3 Value 0 mbar is displayed Checking flow measurement On anaesthetic machine Switch to spontaneous breathing manual ventilation keep Y piece sealed and fill breathing bag with the 02 flush On PM 8030 4 Select VT with idvT button l Squeeze out breathing bag with Y piece closed 5 A value greater than 0 L is displayed PM 8030 is ready for use 17 3 ...

Page 18: ...confirm Setting limit values for monitoring parameters 4 5 or lnspiratory 02 concentration FiO by vol Airway pressure Paw mbar Expiratory minute volume OE Llmin Anaesthetic agent concentration A Vap by vol Press limit values button The menu selection for limit values is displayed Limit values IPPV MODE 02 VE Paw A Vap Limit values cMANISP MODE 02 VE Paw A Vap IPPV is the display for complete limit...

Page 19: ...ashing I Exit menu Select Exit and confirm The next parameter can now be selected l Press another button Complete setiing of limit values Or l Wait for about 15 seconds time out Factory Setting Standard limit values lower limit upper limit value value Fi02 20 P V 0 40 Min vol OE 3 12 A VaplHal 0 2 A VaplEnf 0 2 A Vapllso 0 2 AW Temp 40 Setting range 18 to 100 oto 98 0 to 40 oto 9 oto 9 oto 9 fixed...

Page 20: ...e actual 02 concentration Depending on clinical indications set or switch off upper limit value Setting Paw limit value Set lower limit value about 8 mbar below plateau pressure Where there is no pleateau pressure set at about 8 mbar below peak pressure The lower limit value may be switched off Set the upper limit value about 10 mbar above peak pfeSWie Setting minute volume GE limit values Recomme...

Page 21: ...s Setting of limit values 0 to 6 by vol r upper limit value I lower limit value Horizontal axis Concentrations set on anaesthetic vaporiser 0 to 5 by vol Example The anaesthetic vaporiser was set at 1 4 by vol the intersection with the lower line projected to the left shows the lower limit value Y about 0 7 by voi The intersection with the upper line projected to the left shows the upper limit val...

Page 22: ... 02 VE Paw A Vap Select Mode and confirm Display MODE IPPV MANISP IPPV default Select MANISPc and confirm Display limit values MANISP active reduced monitoring Activating all limit values Set as described above but 3 Select IPPV and confirm 2 Display Limit values IPPV active All limit values are effective at the set values Selecting default limit values Set as described above but 3 Select fault an...

Page 23: ...ent selected is shown by the particular LED being lit After a cold start allow a warming up time of about 3 minutes No calibration or measurement is possible during this period dashes are shown in the measured value display and monitoring is not taking place Tidal volume VT or minute volume VE 5 Display VTX XXL Or VE XX X Umin Selecting other measured values 6 Press kA T button ...

Page 24: ...erature frequency 3 Display mbar C bpm Pmean AW Temp Freq xx xx xx Change display 4 Press selector button If the fixed upper limit value is exceeded 40 C the temperature measured value flashes Where the temperature censor has been disconnected airway pressure Paw dependent on time is displayed instead of temperature This display can also be used for leak testing If dashes appear below PEEP and Pla...

Page 25: ...respectively Any limit value which has been exceeded can be changed directly with the selector knob to set and to confirm During warning messages for 02 concentration anaesthetic agent concentration or expiratory minute volume VE the appropriate displays flash During warning messages for airway pressure the appropriate limit value segment flashes in the strip display Alarms their causes and remedi...

Page 26: ...by a single tone sequence The red or yellow LED continues to flash the text remains as well as the flashing displays with connected Monitorbus 0 Other Drager equipment which is connected is automatically muted The sound can also be switched off on the Drsger equipment which is connected Switching on alarm tone again 1 Press button again 2 Symbol disappears Setting alarm tone volume 4 5 only during...

Page 27: ...on of other Dreger machines Communication with the PM 6010 Patient Monitor software 3 2 measured values and warnings are transferred according to the MEDIBUS format baudrate of 1200 bit s Communication with the PM 6020 Data Manager measured values warnings and real time curves of flow and pressure are transferred according to the MEDIBUS format baudrate of 19200 bit s Communication with a serial p...

Page 28: ...__________ RF I ______ A maximum of three simultaneous warning messages can be printed out on one line i e the three most important messages in order of priority If a new warning is added or deleted the new warning is printed out according to its priority The print out of this warning line is independent of the pre set time and in addition triggers the print out of a measured value line The proced...

Page 29: ...sure limit on anaesthetic machine Overpressure valve switched off Switch on pressure limit on anaesthetic machine Breathing or ventilation has stopped No volume expired during 15 seconds Insufficient fresh gas supply Tube blocked kinked Leak in hose system Check ventilator Procure adequate fresh gas supply Check hose system The inspiratory 02 concentration is below the lower limit value Check 02 s...

Page 30: ...thing system Correct ventilation parameters Calibrate flow sensor page 13 replace if required Check setting and filling level of anaesthetic vaporiser 02 high 102 fT Oz flush used the inspiratory 02 concentration is above the upper limit value Check 02 setting on the flowmeter block or on the blender in vol high MV r ul Temp high W Temp T Upper limit value for the minute volume has been exceeded F...

Page 31: ... warming up Sensor caliorated incorrectly Sensor or cable not connected or faulty Internal banFry for data storage is discharged Temporary voltage failure Internal au omatic new start Remedy Calibrate sensor page 11 Calibrate sensor Replace sensor capsule page 7 and calibrate Change housing of 02 tensor Calibrate sensor page 13 Replace sensor and calibrate page 13 Calibrate sensor Replace cable an...

Page 32: ...ctive MAN P 0 MODE i Request to calibrate after switching on machine Machine is ready for operation Monitoring is switched off Default limit values selected Limit values for automatic ventilation selected Limit values for manual ventilation or spontaneous breathing selected lower limit value minute volume off upper limit value minute volume off lower limit value Paw off lower limit value A Vap off...

Page 33: ...tion is likely l Remove flow sensor disposable or 0 Reuse flow sensor as long as it is possible to calibrate it The sensor cannot be autoclaved or disinfected Loosen plug on pressure measuring line push ring on coupling back Remove pressure measuring line and filter from the back of the machine and drain condensate from the measuring line 0 Remove 02 sensor and disconnect plug from the back of the...

Page 34: ...unds For users in the Federal Republic of Germany we recommend only disinfectants given in the current DGHM list DGHM German Society for Hygiene and Microbiology For users in other countries we also recommend the above preparations Do not autoclave or disinfect in liquid Wipe any soiling off the housing or cable with a damp disposable cfoth Wipe any soiling off the wire screen of the ensor capsule...

Page 35: ... disposable cloth 0 Wipe disinfection with for instance Buraton 10 F Messrs Schiilke Mayr Norderstedt Follow manufacturer s instructions Alternatively 0 Disinfect in Aseptor 9000 using the 45 C programme in accordance with Instructions for Use First wipe off any soiling with a damp disposable cloth Before re use 0 Re assemble monitor pages 6 to 6 0 Check function page 36 l Immediately before use o...

Page 36: ... about 30 seconds For operation with Monitorbus 0 Set ventilator to IPPV 1 The green LED goes out the PM 8030 is in measuring mode 0 Calibrate flow sensor page 13 0 Calibrate 02 sensor page 11 0 Calibrate anaesthetic agent sensor page 15 l Check pressure measurement page 17 l Check temperature measurement see below Checking temperature measurement Pmean AW Temp Freq xx Remove temperature sen wr fr...

Page 37: ...tenace and also before dispatch for repair 02 sensor replace when calibration is no longer possible Bacterial filter in replace after 1 year pressure measuring line Pressure measuring replace if damaged or after 1 year at the line silicone latest rubber hose and socket NiCd battery for replace after 2 years by trained serviceman mains failure alarm Digital component lithium battery for data protec...

Page 38: ... is lit Display Standby Keep button pressed for at least 3 seconds Display configuration lanauaae RS 232 sens Select tanguage turn knob and confirm press knob Display language CD GiSFDEINL GB English F French D German E Spanish I Italian NL Dutch The actual language used is indicated by on the right in the top line Select the desired language and confirm Press button repeatedly until Display Stand...

Page 39: ...ay configuration lanquaae RS232 sens Select RS 232 turn knob and confirm press knob Display RS 232 printer MEDIBUS printer rate Select rate and confirm Display rate 100 baud 96 0 12 24 46 Ss 192 The actual setting is indicated by on the right in the top line Select desired baudrate and confirm for PM 8010 1200 baud 12 for PM 8020 19200 baud I 92 Press button Display RS 232 MEDINS MEDIEUS printer r...

Page 40: ... RS 232 Urn knob and confirm press knob Display RS 232 printer MEDIBUS printer rate Select xate and confirm Display rate 100 baud 96 0 12 24 48 96 192 The actual setting is indicated by on the right in the top line Select desired baudrate and confirm Press button briefly Display RS 232 printer MEDIBUS printer rate Select sprinter and confirm Display printer 5 Q warning caution Selecr data and conf...

Page 41: ...ut temperature measurement such as for long term ventilation 1 2 3 2 4 2 4 2 4 3 Switch PM 8030 to Standby green LED is lit Display Standby Keep button pressed for at least 3 seconds Display configuration lanauaqeRS 232 sensor Select xensor turn knob and confirm press knob Display sensors on T AW Temp Select sensor and confirm Display example A Vap A Vap on on Ofi Select status xff or xn and confi...

Page 42: ...h selector button o change display or for selection of language and interface Strip display for ventilation pressure Paw or tidal vciume VT with selector button Display for the 02 measured value and display for foiver limit value for 02 Display for anaesthetic agent concentration in fresh gas with selector button for anaesthetic agent 1 lO Display for expiratory minute volume VE or tidal voIu zvsV...

Page 43: ...nec ion for identification of anaesthetic vaporiser optional RS 232 C interface to connect PM 8010 Patient Monitor or PM 8020 Data Masager or a printer Connec ion for additional digital interface optional Connecr on for anaesthetic agent sensor Connec ion for temperature sensor Connec ion for flow sensor Connection for 02 sensor Spigot for pressure measuring line 6 DIN IEC 601 para 19 table 4 max ...

Page 44: ...LED displays together with a two line vacuum fluorescence display VF display 40 stage LED strip display LED strip display 10 to 60 mbar Limit values brighter numerical display VF display 2 digit 2 to 20 mbar 10 to 96 mbar 1 mbar t 4 of measured value at least 1 mbar 7 segment LED 3 digit 5 to 105 vol 1 vol f 3 by vol in measuring range 6 to 16 by vol 1 vol in measuring range 16 to 30 by vol i 3 vo...

Page 45: ...nic separation Operating Data Voltage Current Mains fuse Dimensions W x H x D Weight Classification 25 pole Sub 0 1 screening 2 TxD 3 RxD 7 GND 1 5 kV 100 to 240 V 5OkiO Hz max 0 4 A T 2 A DIN 41662 2x 425 x 66 x 300 mm 3 3 kg I type 6 R con orming to DIN IEC 601 l para 19 table 4 f max permissible earth leakage current 0 5 mA Temperature and flow sensor galvanic separated from protective conducto...

Page 46: ...82 90 032 Sensor Titus A for connection to Driger Titus A anaesthetic machine or Sensor NS 656 AV 1 for connection to Driger NS 656 Anaesthetic Spiromat and AV 1 Anaesthetic Ventilator Vapor mounted on the right hand side Sensor AV 1 82 90 031 for connection to Dreger AV 1 Anaesthetic Ventilator Vapor mounted on the left hand side Test adapter 66 01 349 Special accessories for temperature measurem...

Page 47: ...50 645 02 sensor housing 68 50 720 caps for 02 sensor 5 off M 21 482 Pressure measuring line socket filter hose plug 83 02 841 Measuring connection M 28 833 Temperature sensor 84 05 371 Y piece with connection to temperature senscr M 30 543 Mains cable 2 m 1807323 84 03 735 83 01 795 ...

Page 48: ...NzO or of air and OZ Classification of breathing models The calibration of the sensor applies to defined flow conditions Artefacts arising from fluctuations of the gas column in the hoses or pressure surges during the closing or opening of valves are eliminated by using a specific model of the breathing process This process is based on the physiological expiration flow model where there is a steep...

Page 49: ...ch off automatically This prevents faulty displays and subsequent faulty interpretation I Anaesthetic agent measurement Measuring principle The anaesthetic agent measurement works with the Drsger Iris sensor IRIS InfraRed Inhalation Sensor The anaesthetic agents halothane enflurane and isoflurane absorb a pulsed light beam inside the measuring chamber At a constant pressure the reduction of light ...

Page 50: ...nspiratory oxygen concentration Anaesthetic agent halothane Anaesthetic agent isoflurane Operating mode by vol C bpm by vol monitoring during automatic ventilation IPPV display for complete alarm monitoring Or during manual ventilation or spontaneous breathing MAN SP display for reduced alarm monitoring Airway pressure Peak pressure Positive endexpiratory pressure Plateau pressure Mean pressure Pr...

Page 51: ...34 Earth cable 9 Earth connection 9 Fault 29 Filter 34 37 47 FiO2 4 18 First operation 10 Flow sensor 8 13 14 Measuring principle 48 Flushing 12 Frequency 24 Front 42 Intended use 4 Interface protocol 39 40 IPPV monitoring 18 Language versions lO 16 Leak test 24 Limit values 18 19 20 21 22 Linearity 13 Lithium battery 37 Mains failure alarm 10 Mains fuse 43 45 Mainsplug 10 16 Mains voltage 9 Maint...

Page 52: ... 51 Standard limit values 19 Standby lO 16 Steriiizing 34 storage 44 Sound volume lO 26 Strip display 24 43 45 Technical data 44 Temperature sensor 6 34 Test adapter for 02 sensor 12 Tidal volume 23 24 45 Time out 36 39 40 41 Tone sequence 25 26 Transfer rate 40 Warning messages 25 29 What s What 42 Wipe disinfection 35 Y piece 6 17 ...

Page 53: ...magerwerk Aktiengesellschafl edm Republic of Germany ixi Podach 1339 5 MoislingerAllee 53 55 o 2400 Liibeck 1 90 27 542 GA 6494 100 e Drdgerwerk AG 2nd edxan November 199 Subpa o alteration ...

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