Siemens Drager medical Carina Instructions For Use Manual Download Page 46

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Preparation

Instructions for Use Carina SW 3.n

Preparing the Aeroneb Pro nebuliser

Position the nebuliser near to the patient.

Observe the Instructions for Use of the neb-
uliser being used!

WARNING
During medication nebulisation do not use a
heat and moisture exchanger (HME). Risk of
increased breathing resistance.

WARNING
Do not nebulise flammable medication, fire
hazard!

081

30
15

Summary of Contents for Drager medical Carina

Page 1: ...standing of the per formance characteristics of this medical device the user should carefully read these Instructions for Use before use of the medical device Instructions for Use Carina Sub Acute Care Ventilator Software 3 n ...

Page 2: ...ons device labels and messages on the screen Right hand column the illustration Provides a link with the text and serves as a guide to the ventilator Points mentioned in the text are emphasized and non essential information is omit ted Screen displays guide the user and confirm the steps to be followed 107 Operation 54 Instructions for Use Carina SW 3 n Setting ventilation modes Switching on Carin...

Page 3: ...ortant information about a potentially hazardous situation which if not avoided could result in death or serious injury CAUTION A CAUTION statement provides important infor mation about a potentially hazardous situation which if not avoided may result in minor or mode rate injury to the user or patient or in damage to the medical device or other property NOTE A NOTE provides additional information...

Page 4: ...4 Instructions for Use Carina SW 3 n This page intentionally left blank ...

Page 5: ...ng to the nurse call system 52 MEDIBUS interface 53 Position of the user 53 Start up 55 Information on start up 56 Switching on Carina 56 Checking readiness for operation 57 Selecting an application method 59 Setting the O2 supply 60 Operation 61 Setting ventilation modes 62 Setting ventilation parameters 63 Starting ventilation 63 VC SIMV AF 64 PC BIPAP 66 PC AC 68 SPN PS 70 SPN CPAP 72 Apnoea ve...

Page 6: ...e intervals 108 Replacing the inlet filter 109 Taking the device out of operation for a lengthy period 109 Visual inspection of accessories 110 Disposal 111 Disposing of the internal battery 112 Disposing of the inlet filter 112 Disposing of the device 112 Technical Data 113 Ambient conditions 114 Settings 114 Performance data 115 Measurement displays 115 Monitoring 116 Operating data 117 Classifi...

Page 7: ...nstructions for Use 8 Maintenance 8 Accessories 8 Safe connection with other electrical equipment 8 Patient safety 8 Patient monitoring 8 Functional safety 9 General WARNINGS and CAUTIONS 10 Note on EMC ESD risk for the device function 11 Adequate monitoring of ventilation 11 Back up ventilation with an independent manual ventilation device 12 ...

Page 8: ...monitoring lies solely with the medical device operator WARNING Any use of the medical device requires full understanding and strict observation of all portions of these instructions The medical device is only to be used for the purpose spec ified under Intended Use on page 14 and in conjunction with appropriate patient monitor ing see page 11 Strictly observe all WARN ING and CAUTION statements t...

Page 9: ...nitored patient ventilation with user defined settings for the monitoring functions minimum inspiratory breathing gas flow maximum airway pressure or if one of the limits set is exceeded by an appro priate alarm The medical device is equipped with basic safety features to reduce the possibility of patient injury while the cause of an alarm is reme died ...

Page 10: ...edications or other substances based on flammable solvents such as alcohol must not be introduced into the hose system Fire haz ard If highly flammable substances are used for disinfection adequate ventilation must be ensured WARNING Do not use the device during magnetic reso nance MRI NMR NMI Device operation may be affected thus placing the patient at risk WARNING Do not use the device in hyperb...

Page 11: ...f the device CAUTION Do not expose the device to direct sunlight to pre vent over heating of the device WARNING Only operate Carina with an inlet filter HEPA to prevent infection and dusting patient WARNING If inspiratory oxygen concentration differs from ambient air concentration monitoring of inspiratory oxygen concentration with adjust able high and low alarm limits is needed Con nect external ...

Page 12: ...ndent manual ventilation device WARNING If a fault is detected in Carina so that its life support functions are no longer assured ven tilation using an independent ventilation device must be started without delay if nec essary with PEEP and or an increased inspir atory O2 concentration e g with the Resutator MR 100 ...

Page 13: ...Instructions for Use Carina SW 3 n 13 Intended Use Intended Use Intended Use 14 Sub acute care definition 14 ...

Page 14: ...ble require diagnostics or invasive procedures but not intensive procedures requiring an acute level of care The severity of the patient s condition requires Active physician direction with frequent on site visits Professional nurse care Complex medical and or rehabilitative care Typically sub acute care is designed to return patients to the community or transition them to a lower level of care WA...

Page 15: ...6 Ventilation modes 16 Supplements 16 Hose systems 16 Monitoring 16 Gas supply 17 Power supply 17 Interfaces 17 MEDIBUS 17 Trolley 17 Control panel top 18 Carina underside 18 Front connection block 19 Rear connection block 19 Trolley 1 63 cm Trolley 1 78 cm 20 Symbols 21 Abbreviations 22 ...

Page 16: ...starts ventilation at the predeter mined volume Trigger For the ventilation of spontaneously breathing patients synchronising ventilation with spontane ous breathing SyncPlus For leak compensation Ramp Variable rise in pressure from the lower pressure level to the upper pressure level VG Volume Guarantee VG ensures that patients receive a defined tidal vol ume even during pressure assisted ventila...

Page 17: ...attery External battery optional Active power supply is indicated on the screen Interfaces RS 232 serial port for data communication Nurse call system MEDIBUS Software protocol for the transfer of data between Carina and an external medical or non medical device e g patient monitors or computers for data management systems via an RS 232 interface see MEDIBUS for Dräger Intensive Care Devices 90 28...

Page 18: ... charged LED flashes External power supply mains external battery internal battery is being charged LED off battery operation 7 Start Standby button to switch between standby and ventilation 8 Select Menu button to open the menus for ventilation settings alarms measured values configuration interlock Carina underside 9 Switch for hose system with leak valve or hose system with expiratory valve mas...

Page 19: ...hose system with expiratory valve Rear connection block 4 Not assigned 5 Connection for nurse call system 6 RS 232 serial port for data communication MEDIBUS 7 Not assigned 8 Inlet filter HEPA filter 9 Connection for HPO oxygen supply 10 Connection for LPO oxygen supply 11 Mains switch 12 Connection for external battery 13 Power cable connection 002 1 2 3 003 4 5 6 7 8 9 10 11 12 13 ...

Page 20: ...ley 1 78 cm 1 Carina bracket 2 Standard rail grip 3 Universal bracket with standard rail optional 4 Trolley column 5 Pedastal 6 Red locking lever of the column mount closed under pedestal 7 Dual rollers with locking brakes 4 each 8 Battery holder optional 077 1 2 3 4 7 6 5 8 ...

Page 21: ... Power supply internal battery Power supply external battery Power supply mains Charge of internal battery 90 to 100 Charge of internal battery 75 to 89 Charge of internal battery 50 to 74 Charge of internal battery 25 to 49 Charge of internal battery 0 to 24 Patient effort detection Menu button Lower alarm limit Upper alarm limit Temperature limitation int ext Menu 1 Menu 2 Menu 3 Observe the Ins...

Page 22: ...otocol for medical equipment Mask Mask ventilation MV Minute volume product of set tings VT and f VT x f MVi Inspiratory minute volume MVleak Leakage minute volume NIV Non invasive ventilation mask ventilation Pa Pascal unit of pressure 1 mbar 100 Pa 1 hPa 1 bar 100 kPa 1000 hPa Paw Airway pressure Paw high Airway pressure high PC AC Pressure Control Assist Control Pressure assisted spontaneous br...

Page 23: ... time setting Tube Tube ventilation invasive ventilation UMDNS Universal Medical Device Nomenclature System Nomenclature for medical devices VC SIMV Volume Control Synchronized Intermittent Mandatory Ventila tion Synchronized Intermittent Man datory Ventilation volume con trolled VG Volume Guarantee VT Tidal volume setting VTi Inspiratory tidal volume Abbreviation Explanation ...

Page 24: ...24 Instructions for Use Carina SW 3 n This page intentionally left blank ...

Page 25: ...s with a fixed function 26 Buttons for calling up functions and ventilation parameters 26 Power supply display 26 Dwell time without inputs 26 Screen 27 Layout 27 Colour concept 28 Setting ventilation mode 28 Setting ventilation parameters 28 Calling up menus 29 Expanding menus 29 The following menus can be selected 29 ...

Page 26: ...tandby and ventilation Buttons for calling up functions and ventilation parameters 5 Pressing the button opens the relevant function displayed on the screen or the relevant ventila tion parameter Power supply display 6 Green LED Dwell time without inputs If a changed setting or selection is not confirmed with the rotary knob for more than 30 seconds the previous state is reactivated Flashing Exter...

Page 27: ...on if the set range limit has been reached 6 Display of functions and ventilation parameters activated with the relevant function key Status line for displaying current device settings 2 1 LPO oxygen supply 2 2 Power supply not illustrated 2 3 Charge of internal battery 2 4 Hose system expiratory valve or leak valve 2 5 Application method tube or mask 2 6 Set ventilation mode VC SIMV PC BIPAP PC A...

Page 28: ...ld closes Colour concept Setting ventilation mode 2 Press button for the ventilation mode displayed z To select ventilation mode turn rotary knob z To confirm press rotary knob Setting ventilation parameters 3 Press button for the ventilation parameter 4 To set the value turn rotary knob To confirm press rotary knob Yellow Function parameter selected not yet confirmed Dark green Button can be used...

Page 29: ...he white bar Menu 1 Menu 2 Menu 3 The following menus can be selected Vent Set menu for the ventilation settings for a detailed description see page 62 Alarms menu for displaying and setting the alarm limits for a detailed description see page 84 Values menu for displaying the set values and measured values in the current ventilation mode for a detailed description see page 80 Config menu for sett...

Page 30: ...30 Instructions for Use Carina SW 3 n This page intentionally left blank ...

Page 31: ...using heat and moisture exchangers HMEs 39 Hose systems 39 Connecting a hose system 40 Hose system with leak valve 41 Hose system with expiratory valve 41 Attaching the hinged arm 42 Connecting a respiratory gas humidifier 43 Respiratory gas humidifier without inspiratory heater 44 Respiratory gas humidifier with inspiratory heater 45 Preparing the Aeroneb Pro nebuliser 46 Connecting to the power ...

Page 32: ...op until its snaps into place Positioning Carina z Place Carina on a flat stable surface z Keep the cooling air vents on the underside of Carina free z Keep the emergency air inlet and oxygen over flow free z Keep a clearance of at least 20 cm all round free for air supply Do not cover the device WARNING The distance between the back of the device and any large obstruction or the wall of the room ...

Page 33: ...rolley Use Dräger trolley Trolley 1 63 cm or Trolley 1 78 cm only Before use check readiness for operation of the trolley 1 Red locking lever of the column mount closed 2 Attachments such as standard rail grip or universal bracket firmly secured 3 Locking levers of the Carina holder closed 4 Rubber elements of device mounts in perfect condition 007 077 1 3 3 2 4 ...

Page 34: ...e mounting pins z Move Carina in parallel with the base plate of the device mount until Carina comes to rest on the base plate z Close both locks the red surfaces should not be visible Only touch the grip part of the locks z Check Carina to make sure it is secure z Observe the maximum payload See Trolley on page 118 WARNING Only touch the grip part of the locks Risk of trapping fingers at the lock...

Page 35: ...ng edge 3 For level adjustment use the plate on the upper side of the universal bracket 4 Level the universal bracket 5 Secure adjusting lever Height Adjustment 5 Release adjusting lever and adjust height of universal bracket z Level universal bracket z Retighten adjusting lever Attaching accessories to the standard rail z Attach accessory to the standard rail Observe the maximum payload See Troll...

Page 36: ...holder against the column z Attach the battery holder Use the four provided bolts z Tighten the four bolts Use the provided Allen key z Make sure the battery holder is firmly attached External battery pack 1 Press the locks inwards to open 2 Open the door of the battery holder 3 Slide in the external battery pack z Close the door of the battery holder 089 1 2 090 2 1 3 ...

Page 37: ...g the trolley is walking pace There is a higher risk of it tilting over at thresholds on uneven floors and on ramps Reduce moving speed further CAUTION Do not tilt the trolley with accessories in the worst position by more than 10 Otherwise the tilt sta bility is no longer assured CAUTION When using Carina in combination with other products the equipment s owner must ensure that it is adequately s...

Page 38: ...s for Use Carina SW 3 n Moving the trolley 1 Release all four locking brakes 2 Hold and move the trolley by gripping the stand ard rail or the trolley column Parking the trolley 3 Engage all four locking brakes 012 1 018 2 026 3 ...

Page 39: ... the patient connection cannot be directly monitored by the ventilator Therefore z The condition of the patient and the ventilator s measured values for air volume must be checked more frequently z Follow the Instructions for Use of the heat and moisture exchanger HME z Position the filter near to the patient Hose systems WARNING Always use an inspiratory bacterial filter or HME F to reduce possib...

Page 40: ...y from the actual volumes WARNING Do not use antistatic or conductive hoses The use of such materials increases the risk of an electric shock for the patient and the risk of fire breaking out due to oxygen WARNING Only use hoses and masks that conform to ISO 5356 1 Otherwise hoses might discon nect during ventilation WARNING Route hoses safely Eliminate the risk of stum bling Do not kink hoses Kee...

Page 41: ... the leak valve is included z Check that the hose system is displayed in the status line of the screen as follows LeakV Hose system with expiratory valve 1 Open the sliding cover on the underside of Carina 2 Using a coin turn the switch to expiratory valve until it is properly engaged 3 Close the sliding cover CAUTION Switching between a hose system with leak valve and a hose system with expirator...

Page 42: ...VENTSTAR Carina ExpV MP 00 313 the expiratory valve is included 7 Connect the pilot line of the expiratory valve to pilot hose socket z Check that the hose system is displayed in the status line of the screen as follows ExpV Attaching the hinged arm Dräger recommends using a hinged arm to prevent the ventilation hose from kinking z Attach the hinged arm to the universal rail of the trolley with th...

Page 43: ...hose system which could lead to hypoventilation WARNING Only use distilled water for the respiratory gas humidifier Risk of infection of the airways WARNING When using a respiratory gas humidifier do not use a heat and moisture exchanger HME at the same time Risk of increased breathing resistance because of condensation WARNING Use the F P MR 810 respiratory gas humidi fier only in conjunction wit...

Page 44: ...ose connection 4 Connect the leak valve making sure the direc tion is correct For hose system with expiratory valve z Turn the switch to expiratory valve see page 41 1 Connect the filter to socket 2 Connect ventilation hoses observing hose lengths 3 Place the water trap vertically at the lowest point of the hose connection 4 Connect the expiratory valve to the nozzle of the ventilation hose 5 Conn...

Page 45: ...serving hose lengths 3 Install the leak valve making sure the direction is correct For hose system with expiratory valve z Turn the switch to expiratory valve see page 41 1 Connect the filter to socket 2 Fit the ventilation hoses according to the instructions for the respiratory gas humidifier observing hose lengths 3 Connect the expiratory valve to the nozzle of the ventilation hose 4 Connect the...

Page 46: ...ition the nebuliser near to the patient z Observe the Instructions for Use of the neb uliser being used WARNING During medication nebulisation do not use a heat and moisture exchanger HME Risk of increased breathing resistance WARNING Do not nebulise flammable medication fire hazard 081 30 15 ...

Page 47: ...A 1 Plug the power cable into the device and secure with the wire clip 2 Insert the mains plug into a power socket The LED flashes or lights up according to the charge of the internal battery CAUTION Maintain a sufficiently charged external battery on hand in the possible event of a power supply failure NOTE Route hoses safely to reduce the risk of tripping WARNING IEC 60601 1 1 Edition 2004 Safet...

Page 48: ...nal battery 3 Connect the cable to the microfuse The LED flashes or lights up according to the charge of the internal battery The external battery is not charged from the Carina mains supply WARNING Mains powered equipment must not be con nected to the connection for an external bat tery Risk of electric shock or equipment damage CAUTION Avoid high resistance in conjunction with the external batte...

Page 49: ...ery can be fully charged within a charging time of approx 2 hours Refer to Maintenance of the internal battery on page 110 The LED lights up WARNING Before transporting the device within the clinic check that the internal battery is suffi ciently charged Otherwise the correct func tioning of the Carina may be compromised CAUTION Recharge the battery if it has not been used for a lengthy period Ref...

Page 50: ...tration WARNING Patients depending on ventilation need either monitoring of expiratory tidal volume or mon itoring of expiratory minute volume or moni toring of endtidal expiratory CO2 concentration Connect appropriate external monitor to hose system Otherwise no alarm will be activated if patient s ventilation deteriorates WARNING In the case of patients who require a high O2 concentration ensure...

Page 51: ...bile oxygen source separate from a central high pressure O2 supply 1 Remove the cap from the LPO nozzle for O2 supply 2 Connect the O2 supply hose from the O2 source to the LPO nozzle 3 Connect a flow control valve on the O2 cylinder with pressure gauge or a concentrator Observe the Instructions for Use for the O2 components WARNING O2 compressed gas must be dust free oil free and dry and its pres...

Page 52: ...ny disconnection or cable break will trigger a nurse call z Plug into the socket on the rear of the device z Check that the connected nurse call system is operating correctly Technical data of the nurse call system WARNING A nurse call system used in conjunction with Carina must conform to IEC 60601 1 8 and transmit alarms from Carina within 5 seconds Risk of injury to patient if alarms are not ti...

Page 53: ...he plug into the socket on the rear of Carina and screw tight Position of the user The device is always operated from the side look ing onto the hose connections as seen by the user CAUTION The data port data transfer may only be con nected by EDP Electronic Data Processing staff trained in maintenance and repair 020 ...

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Page 55: ...on start up 56 Switching on Carina 56 Checking readiness for operation 57 Connecting test lung 57 Checklist 58 Switching Carina to Standby 59 Selecting an application method 59 Selecting a mask 59 Selecting a tube 59 Setting the O2 supply 60 Placing the oxygen sensor 60 ...

Page 56: ...st During the self test the screen indicates the progress of the self test CAUTION The Carina shall not be operated immediately fol lowing storage or transport outside the recom mended operating conditions Otherwise there is a risk of malfunction After prolonged storage at a temperature and humidity outside the operating range refer to Ambient conditions on page 114 the device must be brought to a...

Page 57: ...ed checklist after a test item has been completed success fully The following functions are checked Operation of LEDs displays and alarm tone Upper alarm limit for Paw Disconnect alarm Apnoea ventilation Mains power failure alarm Connecting test lung The test lung consists of a mask manifold for con necting a catheter nozzle with a diameter of 7 mm for simulating the resistance of airways and a 2 ...

Page 58: ... 20 mbar Tdisconn 0 s Press Start Standby button to start the ven tilation and squeeze the test lung several times strongly during inspiration Each time the lung is compressed expira tion should be initiated instantly After the second compression on Pinsp level alarm tone starts and Airway pressure high is displayed 7 Confirm alarm then disconnect the test lung from the hose system Alarm tone star...

Page 59: ...on method In the configuration menu set the method to Mask or Tube Setting is only possible in standby mode and for hose systems with leak valve Selecting a mask z Press Select Menu button z Press Config button z Press button z Press Method button z Select and confirm Mask with rotary knob Selecting a tube z Press Select Menu button z Press Config button z Press button z Press Method button z Sele...

Page 60: ...use of an external oxygen monitor add to the patient circuit to measure the actual oxygen concentration Carina displays the concentration set by the user but does not denote the actual concentration delivered to the patient Placing the oxygen sensor The oxygen sensor for the oxygen monitor should be placed directly at the patient connection port of Carina before the mask or tube 093 ...

Page 61: ... ventilation 73 Volume guarantee 74 Switching on VG 74 NIV Non invasive Ventilation 75 Using mask ventilation 75 Selecting the Mask application method 76 Setting ventilation parameters 76 Automatic leak compensation of the triggers 76 Selecting the Tube application method 76 LPO Low Pressure Oxygen mode 77 Setting LPO mode 78 Setting O2 concentration 78 Switching off LPO mode 78 Chart for operatio...

Page 62: ...the ventilation settings menu 1 Press Select Menu button 2 Press the Vent Set button and the ventilation mode last set is indicated Changing the ventilation mode 3 Press button for the ventilation mode z Select and confirm the ventilation mode using the rotary knob Carina can use the following ventilation modes VC SIMV PC BIPAP PC AC SPN PS VG SPN CPAP 035 1 507 2 506 3 ...

Page 63: ...remain intact when the device is switched off Starting ventilation z Press the Start Standby button Carina ventilates at the ventilation parameters set The screen shows the current ventilation wave forms and values For configuration of the screen display see page 92 Ventilation mode PC AC VT 500 mL Pinsp 15 mbar PEEP 3 mbar FiO2 40 f 15 bpm Ti 1 3 s Ti max 4 s I E 1 2 Δ Psupp 12 mbar CPAP 3 mbar R...

Page 64: ...ventilation parameters Tidal volume VT Positive end expiratory pressure PEEP O2 Concentration FiO2 Sensitivity of Trigger for synchronising man datory ventilation strokes Frequency f Inspiration time Ti or I E configurable see page 94 Pressure rise time Ramp Maximum airway pressure Pmax z Non invasive ventilation with a hose system with leak valve using the Mask application method see page 75 z Se...

Page 65: ...olume VT mL 100 to 2000 PEEP mbar 3 to 20 Inspiratory O2 concentration FiO2 21 to 100 Trigger sensitivity Trigger Off Normal Sensitive Frequency f bpm 5 to 50 Inspiration time Ti sec or I E 0 3 to 8 1 39 to 2 1 Ramp rise time Ramp sec Auto 0 1 to 2 0 Pressure limitation Pmax mbar LeakV 5 to 40 ExpV 5 to 50 ...

Page 66: ...al by gradually reducing the mandatory portion of total minute volume MV Set PC BIPAP with the buttons for the ventilation parameters Inspiration pressure Pinsp Positive end expiratory pressure PEEP O2 concentration FiO2 Sensitivity of Trigger for synchronising spontaneous breathing Frequency f Inspiration time Ti or I E configurable see page 94 Pressure rise time Ramp z Non invasive ventilation w...

Page 67: ...EEP value LeakV 5 to 40 ExpV 5 to 50 PEEP mbar An increase in PEEP value necessitates an increase in the Pinsp value when a min imum difference of 2 mbar has been reached 3 to 20 Inspiratory O2 concentration FiO2 21 to 100 Trigger sensitivity Trigger Off Normal Sensitive Frequency f bpm 5 to 50 Inspiration time Ti sec or I E 0 3 to 8 1 39 to 2 1 Ramp rise time Ramp sec Auto 0 1 to 2 0 ...

Page 68: ...ure Pinsp Positive end expiratory pressure PEEP O2 concentration FiO2 Sensitivity of Trigger for synchronising spontaneous breathing Frequency f Inspiration time Ti or I E configurable see page 94 Pressure rise time Ramp z Non invasive ventilation with a hose system with leak valve using the Mask application method see page 75 z Setting alarm limits see page 84 037 Flow Paw Ti PEEP Pinsp Ramp high...

Page 69: ...EEP value LeakV 5 to 40 ExpV 5 to 50 PEEP mbar An increase in PEEP value necessitates an increase in the Pinsp value when a min imum difference of 2 mbar has been reached 3 to 20 Inspiratory O2 concentration FiO2 21 to 100 Trigger sensitivity Trigger Off Normal Sensitive Frequency f bpm 5 to 50 Inspiration time Ti sec or I E 0 3 to 8 1 39 to 2 1 Ramp rise time Ramp sec Auto 0 1 to 2 0 ...

Page 70: ...support Δ Psupp Positive end expiratory pressure PEEP O2 concentration FiO2 Sensitivity of Trigger for synchronising spontaneous breathing Maximum inspiration time Ti max Pressure rise time Ramp SPN PS can be expanded with the following venti lation parameters Apnoea ventilation see page 73 Volume guarantee see page 74 With apnoea Ventilation or volume guarantee switched on z Set pressure limitati...

Page 71: ...P PEEP mbar 3 to 20 Inspiratory O2 concentration FiO2 21 to 100 Trigger sensitivity Trigger Normal Sensitive Maximum inspiration time Ti max sec 0 4 to 10 0 Ramp rise time Ramp sec Auto 0 1 to 2 0 Apnoea ventilation Apn Vent On Off Volume guarantee VG On Off Pressure limitation Pmax mbar Only with apnoea ventilation or volume guarantee switched on LeakV 5 to 40 ExpV 5 to 50 ...

Page 72: ...PN CPAP can be expanded with the following ventilation parameters Apnoea ventilation see page 73 With apnoea Ventilation switched on z Set pressure limitation Pmax z Non invasive ventilation with a hose system with leak valve using the Mask application method see page 75 z Setting alarm limits see page 84 Setting ranges Ventilation parameter Setting range CPAP mbar 3 to 20 Inspiratory O2 concentra...

Page 73: ...s back to the previous ventilation mode Switching on apnoea ventilation For ventilation mode SPN PS in menu 3 for ventilation mode SPN CPAP in menu 2 z Press Apn Vent button z Select and confirm On with rotary knob z To set apnoea alarm time see page 84 z Set pressure limitation Pmax To switch off z Select Off and confirm VTapn setting parameter is based on volume setting mode VC SIMV or VG fapn s...

Page 74: ...is applied Set volume guarantee with the parameters Tidal volume VT Pressure limitation Pmax Switching on VG z In menu 3 press the VG button z Select and confirm On with rotary knob z Set Pmax z Set VT To switch off z Select Off and confirm WARNING Set Pmax in such a way that critical airway pressures are avoided WARNING In VC SIMV and SPN PS VG mode it is not pos sible to guarantee volumes if the...

Page 75: ... inspiratory time decreases exhalation time allowing less CO2 to be purged from the circuit before the next cycle In such circum stances higher tidal volumes further increases the volume of CO2 re breathed by the patient WARNING An intubated patient must not be ventilated in Mask mode A leakage may lead to a temporary change of the delivered volume to the patient WARNING In the Mask application me...

Page 76: ...n parameters z Perform as described for the Tube applica tion method Automatic leak compensation of the triggers Carina compensates leaks for the detection of a trigger initiated by the patient If leaks are higher than 50 L min an alarm is given For further description see page 138 Selecting the Tube application method z Switch Carina to standby mode z Press Select Menu button z Press Config butto...

Page 77: ...and for use with oxygen are to be used between Carina and the O2 source NOTE Automatic O2 control of Carina is not in operation in LPO mode The O2 concentration can only be set via the following parameters For leak valve as a function of Pmean and LPO flow For expiratory valve as a function of minute volume and LPO flow NOTE If O2 is simultaneously supplied from the central gas supply or a gas cyl...

Page 78: ... oxygen from escaping The patient s O2 concentration is influenced by the hose system used O2 concentration delivered by the O2 concen trator used set O2 flow on the O2 concentrator LPO flow administered minute volume on Carina MV mean airway pressure Pmean The O2 concentration for the patient is set at the defined ventilation parameters only using flow reg ulation at the flow control valve or at ...

Page 79: ... Chart for operation with expiratory valve MP 00 313 Chart for operation with leak valve MP 00 312 079 Minute volume in L min FiO2 as a function of minute volume and LPO flow 078 Mean airway pressure in mbar FiO2 as a function of Pmean and LPO flow ...

Page 80: ...aw Locking buttons All the buttons apart from the Audio paused 2 min button can be locked in order to prevent them from being pressed accidentally z Press Select Menu button 3 Press the Un Locked button and keep it pressed until the colour of the button switches to red and the button indicates Locked Unlocking z Press the Locked button to unlock again NOTE Measured Frequency on VC SIMV and PC BIPA...

Page 81: ...utton flashes The screen shows Standby Patient not ventilated Switching off the device z Switch Carina to standby 1 Set the mains switch to Carina is switched off Carina cannot be switched off during ventilation Carina signals Set standby to shut off The internal battery is also charged when the device is switched off To disconnect from the mains and terminate charg ing z Disconnect mains plug 034...

Page 82: ...on nect test lung and operate the Carina in manda tory ventilation mode VC SIMV PC AC or PC BIPAP until the battery is completely dis charged The LED is no longer illuminated Carina stops ventilation Do not interrupt the discharging process z Set the mains switch to off z Reconnect the power cable The internal bat tery is charging the LED flashes Charge internal battery completely at least 4 hours...

Page 83: ... Use Carina SW 3 n 83 Monitoring Monitoring Setting alarm limits 84 In the event of an alarm 85 More than one alarm at the same time 86 Troubleshooting 86 Suppressing the alarm tone 86 Alarm after battery discharge 86 ...

Page 84: ...e rotary knob and con firm Upper alarm limit Lower alarm limit Alarm limit Setting range Value set on delivery Paw high 10 to 55 mbar 25 mbar MV high 2 to 40 L min 15 L min MV low 0 1 to 39 L min 3 L min f high 10 to 50 bpm 20 bpm Tapn 5 to 60 seconds 15 seconds Tdisconn Mask 0 15 30 60 90 120 seconds Tube 0 15 30 60 seconds 15 seconds WARNING Set the alarm limits according to the patient s condit...

Page 85: ...or lights up red or yellow Alarm with the highest priority Message appears on a red background and is high lighted with three exclamation marks Example MV low Carina generates a five tone sequence which is sounded twice and repeated every 13 seconds The LED in the Audio paused 2 min button flashes red Alarm with medium priority Message appears on a yellow background and is highlighted with two exc...

Page 86: ...creen goes out Suppressing the alarm tone for up to 2 minutes 1 Press Audio paused 2 min button The alarm tone is suppressed for approx 2 minutes 2 The symbol is displayed on the screen If you wish to reactivate the audible alarm before the end of this time z Press Audio paused 2 min button again If an alarm with a higher or equal priority occurs during the period when the alarm tone is sup presse...

Page 87: ...system information 90 Setting system time 90 Setting the language 91 Displaying contact information 91 Displaying the log book 91 Setting volume of the alarm tone 91 Setting the alarm tone 91 Selecting screen display 92 Selecting display for 2 measured values 93 Selecting an application method 93 Switching LPO mode on off 93 Selecting Ti or I E 94 Setting the night screen 94 ...

Page 88: ...de on off Selection of mask or tube ventilation Selection of the Ti or I E setting Night screen on off The settings performed under Config remain stored when the device is switched off The following information on the device can be called up under Config System information Information on how to contact DrägerService Log book for technical alarm messages Calling up the Config menu 1 Press Select Me...

Page 89: ... LPO for setting LPO oxygen supply Ti I E for selecting the setting used for Ti or I E ratio Night for switching on the screen in night time mode To set z Press the appropriate button for function or parameter z Select the value using the rotary knob and con firm Service menu The Service menu is password protected The password can only be changed by DrägerService If you have forgotten the password...

Page 90: ...g system information z Press Syst info button The system informa tion is displayed Setting system time The system time can be changed only on standby setting After opening system information the current sys tem time is highlighted in white Elements of system time year month day hours minutes seconds z Press the rotary knob to highlight the first ele ment year Set and confirm with the rotary knob T...

Page 91: ...contact information z Press Contact button Information on how to contact DrägerService Displaying the log book z Press Logbook button The log book shows the technical alarms as information for servicing purposes Technical alarm messages are avail able only in English Setting volume of the alarm tone 1 Press Volume button z Set value from 1 to 5 and confirm The volume selected is displayed Setting ...

Page 92: ...t 1 Press Screen button z Select Curves or Measure and confirm The current setting is displayed in the button 2 Pressure curve as a bar chart 4 measured val ues and 2 configurable measured values To configure the measured value display see page 93 3 Flow and pressure curve in real time and 2 con figurable measured values To configure the measured value display see page 93 540 1 548 2 552 3 ...

Page 93: ...Select display and confirm Selecting an application method z To switch Carina to standby see page 59 4 In menu 2 press the Method button z Select and confirm Mask or Tube with rotary knob The application method selected is displayed in the status line on the screen The Mask application method is only available for hose systems with leak valve Switching LPO mode on off z To switch Carina to standby...

Page 94: ...d confirm Setting the night screen If the device is set to Night screen and it is not operated for 3 minutes or no alarm has occurred the screen switches off The screen is switched back on again as soon as any action is performed on the device 2 In menu 3 press the Night button To switch on z Select night mode On and confirm To switch off z Select night mode Off and confirm 541 1 542 2 ...

Page 95: ...Instructions for Use Carina SW 3 n 95 Fault Cause Remedy Fault Cause Remedy Fault Cause Remedy 96 Displaying technical alarm causes 101 Rescue Ventilation 101 ...

Page 96: ...larm message Error message Cause Remedy Airway pressure high Note This is only displayed after the 2nd ventilation stroke The excess pressure alarm can be caused by continuous coughing Check condition of patient check ventilation pattern cor rect alarm limit if necessary Airway pressure low A connection has become detached in the hose system Ventilation not possible Make sure the hoses filters and...

Page 97: ...r 5 to 30 seconds Air supply blocked The ventila tion function is not optimal Hose system blocked or leak ing Make sure there is a free sup ply of air If there is a free sup ply of air Check the hose system filters and other com ponents for free flow and leaks Use a replacement device Call DrägerService Device failure in log book Device failure The device has a fatal techni cal problem Ventilation...

Page 98: ... valve The hose system connected does not correspond to the device setting Use the correct hose system Or Correct the device setting Inlet filter missing The inlet filter has been removed or is not inserted cor rectly Insert inlet filter Check that the inlet filter is secure Insp temperature high in log book Insp temperature high Breathing gas temperature above 40 C Make sure the ambient temper at...

Page 99: ...owing to external influences Make sure there is a free sup ply of air to the inlet filter Remove any obstructions for eign bodies kinked hoses from the hose connections and hose system Reduce ambient temperature Invalid date The date setting is incorrect Correct the date Call DrägerService Key locked Locked function is acti vated Press the Locked button again thus making it possible to use the but...

Page 100: ... calibration failed O2 calibration failed Call DrägerService Rescue Ventilation in log book Rescue Ventila tion The device has a technical problem and switches to emer gency operation Ventilation is not optimal Make sure there is a free sup ply of air to the inlet filter Remove any obstructions for eign bodies kinked hoses from the hose connections and hose system Use a replacement device Call Drä...

Page 101: ...tion Ventilation is in standby mode To start ventilation press the Start Standby button Technical alarm in log book Technical Alarm The device has a technical problem This alarm does not affect to the breathing function e g hard key defect Use a replacement device Call DrägerService Technical alarm in log book Technical Alarm The device has a technical problem This alarm does not affect to the bre...

Page 102: ...102 Instructions for Use Carina SW 3 n This page intentionally left blank ...

Page 103: ... disinfection and sterilisation 104 Care list 105 Dismantling the components 105 Respiratory gas humidifier medication nebulizer 105 Ventilation hoses 105 Cleaning 106 Wipe disinfection 106 Wipe disinfection with Virex Tb 106 Damp heat disinfection 106 Autoclave sterilisation at 134 C 106 Reprocessing of accessories 106 Before reusing on patient 106 ...

Page 104: ...RNING In case of potential contamination with body fluids clean and disinfect the device Wear protective clothing goggles disposable gloves etc Risk of infection for hospital staff and other patients WARNING Personnel should take precautions to avoid direct contact with chemical disinfectants and they should always be used in well ventilated areas Material Safety Data Sheets MSDS should be readily...

Page 105: ...always hold them at the connection sleeves and not the spiral ribbing Otherwise the spiral ribbing may become detached e g at the connection sleeve or the hose can be torn out of the sleeve z Drain condensate from ventilation hoses z Disinfect and clean ventilation hoses water traps and their removed collecting jars What Cleanable components How often Recommended cleaning intervals How Carina basi...

Page 106: ...e concentration temperature and exposure times are different for each disinfectant and the dis infectant manufacturer s directions for use must be followed carefully Chemical disinfectants should not be mixed with each other or with detergents since this may inac tivate their disinfecting properties or create noxious fumes Items should be dry to prevent dilution of the disinfectant Wipe disinfecti...

Page 107: ...nance Maintenance intervals 108 Replacing the inlet filter 109 Taking the device out of operation for a lengthy period 109 Taking the device out of service 109 Storing the device 109 Maintenance of the internal battery 110 Visual inspection of accessories 110 ...

Page 108: ...ter HEPA filter Replace after 6 months or in accordance with hospital specific regulations page 109 For disposal see page 112 NiMH battery To be replaced by technicians after 3 years NiMH batteries should be disposed of as spe cial waste see page 112 Blower Annual inspection by technicians Device inspection and maintenance Annual inspection by technicians Only original Dräger parts should be used ...

Page 109: ...o place Taking the device out of operation for a lengthy period Taking the device out of service z Switch off the device z Disconnect cables and hoses z Discard any disposable components and obtain new disposable components z Clean and disinfect reusable components z Remove inlet filter discard and obtain a new inlet filter Storing the device Only store the device under permissible ambient conditi...

Page 110: ...ore frequently at higher tem peratures Visual inspection of accessories CAUTION Even accessories designed to be reused e g after reprocessing have a limited service life Due to a number of factors connected with handling and reprocessing e g disinfectant residues can attack the material more intensely during auto claving increased wear can occur and the serv ice life can be markedly shortened Thes...

Page 111: ...Instructions for Use Carina SW 3 n 111 Disposal Disposal Disposing of the internal battery 112 Disposing of the inlet filter 112 Disposing of the device 112 ...

Page 112: ...At the end of the service life z Dispose of the device according to national waste disposal regulations or z have the device disposed of by a suitable waste disposal company For information consult your environment agency and local government offices For countries subject to EU Directive 2002 96 EC This device falls under the scope of EU Directive 2002 96 EC WEEE It is not registered for use in pr...

Page 113: ...Measurement displays 115 Monitoring 116 Operating data 117 Power supply 117 Gas supply 117 Screen 118 Classification 118 Relevant standards 118 Connections 118 Trolley 118 Hose systems 119 EMC Declaration 120 General information 120 Electromagnetic emissions 121 Electromagnetic immunity 121 Recommended separation distances 123 ...

Page 114: ...with leak valve MP 00 312 disposable single hose system with controlled expiratory valve MP 00 313 disposable Ventilation modes VC SIMV PC BIPAP PC AC SPN PS VG SPN CPAP Tidal volume VT 100 to 2000 mL BTPS Resolution 10 mL PEEP Range 3 to 20 mbar Resolution 1 mbar Pressure limitation Pmax 5 to 50 mbar Resolution 1 mbar Inspiration pressure Pinsp Only values higher than PEEP 2 mbar can be set Leak ...

Page 115: ...on resistance 6 5 mbar at 60 L min 4 0 mbar at 30 L min Safety valves Open the breathing system in the event of a fault Overpresssure Opens above 60 mbar Vacuum Opens below 3 mbar Supply system for patient flow High dynamic blower Max inspiratory flow 180 L min at 21 Vol O2 and normal ambient conditions 120 L min at 100 Vol O2 and normal ambient conditions Measurement displays Inspiratory peak pre...

Page 116: ...e 2 to 40 L min in 0 1 L min increments Alarm lower alarm limit If the lower alarm limit has been exceeded Setting range 0 1 to 39 L min in 0 1 L min increments Airway pressure Paw Alarm upper alarm limit If the Paw high value has been exceeded Setting range 10 to 55 mbar in 1 mbar increments Delay time Tdisconn Mask ventilation 0 15 30 60 90 120 seconds Tube ventilation 0 15 30 60 seconds Apnoea ...

Page 117: ...6 to 0 5 A Output voltage 24 V DC 15 to 25 0 to 5 A Charging time 10 hours from an empty battery to a fully charged battery only charge indoors Operating time 8 hours at average ventilation parameters and normal ambi ent conditions Type Lead battery Gas supply HPO O2 service pressure 2 7 to 6 bar 270 to 600 kPa O2 flow 0 to 120 L min Connection thread O2 Country specific Required composition of ga...

Page 118: ...y IEC 601 1 1988 A1 1991 A2 1995 IEC 60601 1 2 Medical electrical devices part 1 General requirements for safety 2nd supplementary standard Electromagnetic com patibility requirements and testing IEC 60601 1 2 2001 A1 2004 Connections Nurse call system max 40 V AC DC max 500 mA potential free safety extra low voltage isolated from mains voltage Data port RS 232 Trolley Dimensions with Carina brack...

Page 119: ...e 25 mL min Classification in accordance with Direc tive 93 42 EEC Appendix IX for MP 00 312 IIa for MP 00 313 IIb UMDNS code 14 238 Materials for MP 00 312 VENTSTAR Carina LeakV Hose Ethylene Vinyl Acetate Connector Polypropylene Leak valve Polycarbonate Materials for MP 00 313 VENTSTAR Carina ExpV Hose Ethylene Vinyl Acetate Connector on device Polypropylene Connector on patient side Polycarbona...

Page 120: ...missions or decreased immunity of Carina The Carina should not be used adjacent to or stacked with other equipment if adjacent or stacked use is inevitable Carina should be observed to verify normal operation in the configu ration in which it will be used Description Order No DC cable S 1 75 m 84 14 048 Cable mains Euro CL II 2 5 m 57 30 042 Power cable Switzerland 3 m 10 A 18 51 691 Power cable I...

Page 121: ...B Carina is suitable for use in all estab lishments including domestic estab lishments and those directly connected to the public low voltage power supply network that supplies buildings used for domestic pur poses Harmonic emissions IEC 61000 3 2 Class A Voltage fluctuations flicker IEC 61000 3 3 Complies Immunity against IEC 60601 1 2 test level Compliance level of Carina Electromagnetic environ...

Page 122: ...m Recommended separation distance from portable and mobile RF transmit ters with transmission power PEIRP to the Carina including its lines 1 84 m x PEIRP 1 Conducted RF IEC 61000 4 6 150 kHz to 80 MHz outside ISM bands 3 Vrms 10 Vrms Recommended separation distance from portable and mobile RF transmit ters with transmission power PEIRP to the Carina including its lines 1 84 m x PEIRP 1 150 kHz to...

Page 123: ...m 1 3 V m distances to transmitters with frequencies from 150 kHz to 2 5 GHz otherwise 1 V m distance 1 V m distance1 m Examples 0 001 0 06 0 17 0 003 0 10 0 30 0 010 0 18 0 55 0 030 0 32 0 95 e g WLAN 5250 5775 Europe 0 100 0 58 1 73 e g WLAN 2440 Europe Bluetooth 0 200 0 82 2 46 e g 5250 not in Europe 0 250 0 91 2 75 e g DECT devices 1 000 1 83 5 48 e g GSM 1800 GSM 1900 UMTS mobiles WLAN 5600 n...

Page 124: ...124 Instructions for Use Carina SW 3 n This page intentionally left blank ...

Page 125: ... SPN CPAP 135 Tube Invasive ventilation 135 Mask ventilation Non invasive ventilation 136 Information concerning CO2 re breathing 137 SyncPlus 138 Multi sence trigger 138 Automatic leakage compensation hose system with leak valve 138 Cycle learning 138 Volume Guarantee VG 138 Volume measurement 139 VTi hose system with leak valve 139 VT hose system with expiratory valve 139 MVi hose system with le...

Page 126: ...on the proces sor controlled blower speed The small mass of the blower wheel allows rapid speed changes and hence high flow dynamics In the measuring unit 3 the compressed air is guided through a restriction R2 The resulting difference in pressure is measured by the flow sensor DPS1 and used for automatic flow control HPO control board Sensor board 6 7 3 Patient Motor blower 1 CV1 F1 CV2 pilot lin...

Page 127: ...s any impurities that might impair operation of downstream components The oxygen arrives at the electrically controlled O2 proportional valve V5 with which the O2 flow is regulated In the O2 measuring unit 7 the oxygen is guided through a restriction R4 The resulting difference in pressure is a measure of the amount of O2 flow and is measured by the O2 flow sensor DPS3 and used to regulate the O2 ...

Page 128: ... loss due to the compliance of the different hose systems con sider the following table MVlost minute volume lost VTlost tidal volume lost x f frequency Hose system ΔP above PEEP Volume loss VTlost MP 00 312 21 65 643 5 mbar 4 mL MP 00 312 21 65 643 10 mbar 7 mL MP 00 312 21 65 643 15 mbar 11 mL MP 00 313 5 mbar 4 mL MP 00 313 10 mbar 7 mL MP 00 313 15 mbar 11 mL MP 00 313 20 mbar 14 mL MP 00 313 ...

Page 129: ...w trigger of the device ensures that the mandatory ventilation stroke is triggered within a trigger win dow with the spontaneous inspiration The trigger window has a maximum length of 5 seconds At expiration times of less than 5 seconds it covers the entire expiration time minus a minimum expiration time of 500 ms Since synchronization of the mandatory ventilation stroke reduces the effective SIMV...

Page 130: ...inspiration time Ti is typically much longer than the fill time of the lung The inspiration pressure PIP corresponds to the minimum value resulting from both tidal volume VT and compliance C of the lungs Carina automatically controls the inspiration flow so that there is no pressure peak due to the resist ances of the tube and airways As is usually the case with constant volume ventilation strokes...

Page 131: ... ventilation stroke The inspiration pressure PIP determined for that venti lation stroke is used by the AutoFlow function as a starting value for inspiration pressure Patient oriented settings The start of mandatory inspiration can be synchro nised with the patient s inhalation effort with the aid of the variable flow trigger In VC SIMV PC AC and PC BIPAP the flow trigger can be switched off com p...

Page 132: ...el is synchronised with the patient s spontaneous breathing The frequency of changes is also kept constant dur ing synchronisation via a trigger window with a fixed position in time Recent clinical experience shows that this good adaptation to the spontaneous breathing of the patient results in less sedation requirement and thus a quicker return of the patient to complete spontaneous breathing As ...

Page 133: ...sition from controlled ventilation via the weaning phase to fully spontaneous breathing is achieved by a grad ual reduction of the inspiratory pressure Pinsp and or frequency f PC AC Pressure Control Assist Control Pressure controlled assisted ventilation Used for all patients from those unable to breathe spontaneously to those breathing spontaneously before being weaned off the ventilator The dur...

Page 134: ...Pressure support PS is started when spontaneous inspiration flow reaches the set value of the flow trigger The device then generates a pressure increase which is adjustable to patient breathing demand up to the preselected PS pressure Δ Psupp above PEEP Flow supply can then be adjusted to suit the patient s individual requirements with Ramp With a steep ramp Carina supports insufficient spontaneou...

Page 135: ...ing increases Lower pressure produces less flow through the exhalation port which may not purge all CO2 from the circuit to prevent re breathing The exhalation valve circuit system VentStar Carina ExpV MP 00 313 or Expi ration Vent MP 00 220 reduces the level of CO2 re breathing compared to the level associated with VentStar Carina LeakV MP 00 312 when low pressures are present Using invasive vent...

Page 136: ...ask ventilation non invasive ventilation Carina provides a mode which is specifically designed for non invasive ventilation with a nose or face mask In non invasive ventilation there are usually larger leaks than in tube ventilation For this reason the automatic leak compensation trigger recognition is matched to these special condi tions The alarm and monitoring concept calls for greater attentio...

Page 137: ...ng increases Lower pressure produces less flow through the exhalation port which may not purge all CO2 from the circuit to prevent re breathing Higher tidal volumes fur ther increase the volume of CO2 re breathed by the patient in such circumstances Reducing dead space can also lower potential CO2 re breathing The Airway pressure low alarm can be delayed by up to 60 seconds For this reason the del...

Page 138: ...e Mask and Tube application methods are automatically compensated Volume Guarantee VG The ventilation mode extension VG allows for the volume support on SPN PS mode Carina controls inspiratory plateau pressure automatically in order to deliver the set tidal volume Changes in the mechanical properties of the respiratory system are compensated Tidal volume of delivered breaths remains constant VG is...

Page 139: ...ask breathing gas will frequently dis charge to ambient air around mask The Carina flow sensor is located inside the device near the inspiratory connection During inspiration time breathing gas will be lost after measurement at inspiratory side in the device During expiration time it will be lost before being measured Therefore tidal volume measured for inspiration total delivered flow will be lar...

Page 140: ... value from the registered breath ing rate Non spontaneous breathing patient Device does not detect any trigger effort due to the non spontaneous situation on patient Carina is delivering the flow producing the shape of sine curve pattern The aim of sine curve is to dem onstrate a normal breathing pattern Triggered breathing Device will detect an effort of patient breath Flow delivery will be fast...

Page 141: ...ttery 48 F Fault Cause Remedy 95 H Hinged arm 42 HME 39 Hose system connecting 40 with expiratory valve 41 with leak valve 41 I Inlet filter 52 109 Intended Use 13 Internal battery Display accuracy of the loading capacity 82 Invasive ventilation Description 135 L Leak compensation 76 Locking function 80 Log book 91 LPO Low Pressure Oxygen mode 77 M Maintenance 107 Maintenance intervals 108 Manual ...

Page 142: ...g LPO mode 78 Setting system time 90 Setting the language 91 Settings 114 SPN CPAP 72 SPN PS 16 70 134 Stability 33 Standby 59 Start up 55 56 Status line 27 Storage 109 Sub acute care 14 Supplements 16 Switching off 81 Switching on 56 SyncPlus 138 System overview 15 T Technical Data 113 Terminating ventilation 81 Trolley 33 V VC SIMV AF 16 64 129 Ventilation hoses 106 Ventilation modes 16 62 Venti...

Page 143: ...Instructions for Use Carina SW 3 n 143 This page intentionally left blank ...

Page 144: ...ded for customer information only and will not be updated or exchanged without customer request Directive 93 42 EEC concerning Medical Devices Manufacturer Dräger Medical AG Co KG Moislinger Allee 53 55 D 23542 Lübeck Germany 49 451 8 82 0 FAX 49 451 8 82 20 80 http www draeger com 90 38 907 GA 5665 700 en RI 12 Dräger Medical AG Co KG 6th edition December 2008 1st edition February 2006 Dräger res...

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