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1. PAW 4 Master Tinsp Te gt PAW 4 Slave Sync Tinsp Te gt PAW 4 Slave Async Tinsp gt Te Paw n Slave Invers Te Tinsp gt 02837376 pa Sn L Xera suononasu 8unejedo Operating Instructions EvitaXL 1 US ed Set the ventilation pattern for ILV Slave with the following ventilation parameters Tidal volume VT Inspiratory flow Flow Frequency f Inspiratory time Tinsp O concentration O2 Positive end expiratory pressure PEEP To set Touch the respective screen knob Turn dial knob to adjust setting Press dial knob to confirm setting The f setting does not go into effect immediately Nevertheless to make sure that the two lung compartments are not ventilated with different ventilator rates in the event of inadvertent separation of the two ventilators Set f on the slave device to the same value as on the master as a safeguard In Async slave mode the Tinsp setting will be immediately in effect In Synchronized and Inverse modes Tinsp becomes only active if the devices are inadvertently separated ILV Slave can be supplemented to include the following ventilation mode extensions Flow trigger page 85 Automatic Tube Compensation ATC page 89 Sigh page 91 Pressure Limited Ventilation PLV page 92 These functions can be enabled
2. another EvitaXL or with an Evita 4 or af with an Evita 2 dura OO w O 2 0000000000 A OOOOOOOOOC For all combinations KOONI H 1 LLLLLLLLLA EvitaxL with Evita 2 dura QOOOOOQQQQ or H EvitaxL with EvitaxL or EvitaxL with Evita 4 Connect the ILV ports of the two Evita ventilators using interface cable 84 11 794 m LO ojo g O 0009090 COO COO 0909090 OSOS OSO OSOS OSO OSOS SOROSO O O O O O O O O a O 2080809 73 11737376 Operation ILV Setting the Master and Slave device To perform independent lung ventilation Setup one device for ILV Master mode and the other device for ILV Slave mode Set the desired parameters see page 77 NOTE Activate ILV mode only after all parameters for ILV Master and ILV Slave ventilators have been adjusted Setting ILV Master Volume controlled ventilation with fixed mandatory minute volume MV set with tidal volume VT and ventilator rate f For independent lung ventilation of patients with no spontaneous breathing Set the ILV ventilation pattern with the parameters Tidal volume VT Inspiratory flow Flow Ventilator rate f Inspiratory time Tinsp O2 concentration O2 Positive end expiratory press
3. 30505000 0o Bii oo pe mim i d 10 Check correct operation of connected nurse call system WARNING A fault in any of the components in the link between nurse call and central hospital alarm system e g in the electronics for nurse call in EvitaXL in the EvitaXL power supply or in the enunciator of the central hospital alarm system may result in failure of the nurse call The hospital connections to the central alarm typically use only one channel The ventilator electronics for the nurse call consequently also use only one channel 45 08737376 Preparation Checks of Readiness for Operation Checks of Readiness for Operation To be performed before using on a patient to confirm that the ventilator is working properly and is ready for operation Preparing the adult test lung 84 03 201 for the adult patient circuit The test lung assembly consists of an elbow connector for connection to the Y piece a 7 mm diameter ET tube connector for simulating airway resistance and a 2 liter breathing bag to simulate compliance NOTE Do not use permanently stretched breathing bags these might cause artifacts during the check procedures Insert the elbow connector into the Y piece only when EvitaXL advises you to do so Preparing the infant test lung 84 09 742 for use with the infant patient circuit The test lung consists of a tracheal tube CH 12 to simul
4. 0 000 cece ee eee 93 Using NVidia dai dat Ado weld 93 Setting Alarm Limits Ledine tiende eee eee 96 In the Event of an Alarm lsssssss III n 97 Displaying Graphics sers 52424 dod eee pXe De eir dene UP dC BR ERST 99 Displaying Measured Values s sss Ih 103 Displaying the Logbook ssssssssss IRI 104 Displaying Trends 1 24 hr 0 0 0 cece eee 105 Special FUNCIONS ss fF aS Sa Pacey ee due dum cot idea Rea e s e ay ea 106 Diagnostic FUNCIONS 2 23 228 sie orita a ed pem im rie eiae ire de ete ds 113 Sensors cessa ated ep uadit dee due eleg ate tet GNE a I a 116 Switching off Monitoring Functions ssssssseee nn 126 Selecting Standby Mode ssssssssseeeee ns 127 61 Operation Precautions During Operation Operation Precautions During Operation WARNING Always use ventilator that has been cleaned and disinfec ted and has been successfully tested to be ready for ope ration WARNING In case of a fault in any of the built in monitoring a substi tute has to be provided in order to maintain an adequate level of monitoring The operator of the ventilator must still assume full responsibility for proper ventilation and patient safety in all situations WARNING If a fault is detected in the ventilator and its life support functions are in doubt ventilation must be started without delay with an independent ventilation device resuscita tion bag using PEEP
5. ssssssssssssseee enn 35 Precautions When Using Heat Moisture Exchangers o oooooocccocommo 37 Potential Hazards from Use of Expiratory Bacteria Filters o o o 38 Installing a Heated Humidifier ooocccccccnccnccnccncccccr 39 Ventilating Adults and Children isses 40 Ventilating Infants and Small Children oooocccccccccccncnnc 42 Providing Electrical Supplies and Connections 0000 cece eee eee 43 Gas Supply itn tence deeded du dd aM ud adque ated oh ee ag des 44 Nurse Call Available Option 0 0 00 cece 45 Checks of Readiness for Operation sisse 46 EIN IIR AAR bs bth Oa aca NS perio LM yaks hin dees tia deat ara aes eect 50 Entering the Humidifer Type 0 0 cece 51 Application Mode Selection Tube Mask Optional ooooooommmm o 51 33 Preparation Positioning The Control Panel Preparation Positioning The Control Panel CAUTION Do not drop control panel physical damage to the unit is likely Do not allow control panel to lean against any objects in an upright position When changing panel lay it on its back Mounting the control panel to the ventilator Hang control panel into its mounts on the EvitaXL main unit until it clicks into position Tilting the Control Panel 1 Press segments on the right and left and at the same time tilt control panel to the desired position Mounting the Control Panel to a Wall R
6. Limin MY 700 500 300 100 0 40 x Curves Loops Trends 30 MY 10 VTPSupp RSBi P0 1 PEEPI MEN 711 8 11 i Flow 50 Limin 25 0 25 50 fh V 0 2 4 6 8 Apnea vent On 10 25 o Qo IE O2 Mr Pmean PEEP 10 5 Yol FiO 35 Limin MV 4 5 s MVepn 0 bpm flotas Li min Special Procedure gt E3 Ext Int SIMV AutoFlow ao min 8 15 MY 45 MVspn 0 0 MV 30 20 10 0 7 15 8 15 50 min Flow 25 0 25 50 7004 y 500 300 100 0 r 0 2 4 6 8 10 12 14 16 sec Apnea vent On 10 2 5 Q o e Q KE Oz Vr Tinsp f PEER Press PEEP 100 5 Yol FiO m Limin MV 4 5 E ae Limin MV spn 0 bpm fita 10 L Vn Mi Values e Main Data Special Procedure 6 Ext Int 12637547 12537547 pa SN L Xera suononuasu Burejed Operating Instructions EvitaXL 1 US ed Displaying Measured Values Touch M Values screen key shown on the right of the screen The bar in the key representing the selection 1 2 or 3 of main numerical values and active alarm limits turns black EvitaxL offers two other selections Touch DM Values screen key again The bar in the key representing the next selection turns black and EvitaxL displays the corresponding values Proceed accordingly to view the third selection The three selections are factory configured however they may also be re configured a
7. Pressure controlled ventilation combined with free spontaneous breathing during the whole breathing cycle and with an adjustable pressure assist starting on CPAP level PCV Assist Pressure Controlled Ventilation plus Assisted BIPAPAssist Pressure controlled assisted ventilation APRV Airway Pressure Release Ventilation Spontaneous breathing on two pressure levels with long time ranges independently adjustable Special modes ventilation mode extensions Automatic Tube Compensation ATC optional Can be used with all ventilation modes Provides targeted reduction of the work of breathing attributable to an endotracheal or tracheostomy tube Apnea Ventilation For automatically switching over to volume controlled mandatory ventilation if breathing stops If apnea occurs EvitaXL sounds an alarm after the preset alarm period TApnea and starts volume controlled ventilation NIV mask ventilation optional Non Invasive Ventilation For ventilation with a nasal or facial mask to support non invasive ventilation of patients with spontaneous breathing Choice between mask ventilation and tracheal ventilation of intubated patients ILV Independent Lung Ventilation Separate differentiated synchronised ventilation with two Evita units independently ventilating each lung Licensed trade mark pa Sn L Xera suononasu 8unejedo Operating Instructions EvitaXL 1 US ed Diagnostic functions Int
8. 143 16637547 144 This page intentionally left blank pa Sn Lb Xera suononasu 8unejedo Operating Instructions EvitaXL 1 US ed Dismantling Components oooooccoccccccccnccn ne 146 Disinfecting Cleaning Sterilizing ocooooocccccncocccccco o 150 Disinfecting Cleaning Sterilizing Schedule for the EvitaXL Intensive Care Ventilator ooooooooooo 153 Re assembly 2200 datada ds tds a dd 154 Before Reusing on a Patient 0 ccc eee eee 155 145 Care Dismantling Components Care Clean and prepare the ventilator after each patient WARNING To avoid risks to hospital staff and patients disinfect and clean ventilator after use Always use ventilator that has been cleaned and disinfec ted and has been successfully tested to be ready for operation Always observe accepted hospital hygiene protocols regarding the frequency of patient circuit and expiratory valve changes Recommendation Change patient circuit system and expiratory valve as needed Keep replacement systems ready WARNING Always follow accepted hospital procedures for handling equipment contaminated with body fluids Dismantling Components Switch off both ventilator and humidifier and remove their power plugs from wall outlets Drain water traps and patient circuit Empty water container of the humidifier CO2 sensor available option 1 Remove CO2 sensor
9. 18 Tobin M J Charles G A Discontinuation of Mechanical Ventilation in Tobin M J Principles and Practice of Mechanical Ventilation 1994 1177 1206 19 Guttmann Wolf et al Continuous Calculation of Tracheal Pressure in Tracheally Intubated Patients Anesthesiology Vol 79 Sept 1993 221 Theory of Operation Special ASCII Characters Used Special ASCII Characters Used Characters Explanation Hexadecimal code Control characters NUL Null 00 Q SOH Start of Heading 01 A STX Start of Text 02 B ETX End of Text 03 C EOT End of Transmission 04 D ENQ Inquiry 05 E ACK Acknowledge 06 F BEL Bell 07 G BS Backspace 08 H HT Horizontal Tabulation 09 LF Line Feed 0A J VT Vertical Tabulation OB K FF Form Feed oc AL CR Carriage Return oD M SO Shift Out OE N SI Shift In OF O DLE Data Link Espace 10 P DC1 Device Control 1 11 Q DC2 Device Control 2 12 R DC3 Device Control 3 13 S DC4 Device Control 4 14 T NAK Negative Acknowledge 15 U SYN Synchronous Idle 16 V ETB End of Transmission Block 17 W CAN Cancel 18 X EM End of Medium 19 Y SUB Substitute 1A Z ESC Escape 1B I FS File Separator 1C N GS Group Separator 1D RS Record Separator 1E 25 US Unit Separator 1F a SP Space 20 DEL Delete 7F 222 pa Sn Lb Xera suononasu 8unejedo 224 Ordering Information kessi diaa eiat de d a a eee pa SN L 1Xxe1 3 suononysuj Bunesado 223 Ordering Informat
10. O2 concentration O2 Pressure rise time Slope To set Touch the respective screen knob Turn dial knob to adjust setting Press dial knob to confirm setting To view additional text information on APRV Touch screen key APRV can be supplemented to include the following ventilation mode extensions Apnea ventilation page 86 ATC page 89 These functions can be enabled via Add settings NOTE For setting alarm limits see page 96 Please refer to page 205 for a detailed description of APRV Operation APRV PAW Phigh H a Plow Thigh e Tlow Flow TTA t APRV 9 gp 0720 Paw Pmean PEEP 123 xd Freeze 10 5 Mii vaues S te E e Main 20 Vol 96 FiO AA MA A Data 35 Special 50 Limin Flow 4 Umin MV Procedure ge 45 s o A L min MVspn 25 50 0 Ventilator Settings 22 x bpm frota Baal o qeu Do 1 0 Basic L Vri 4 settings E T ne m 450 Apnea vent On VT pnea 480 Tienes 12 ir ES Ext Phigh Plow li Int 81 01337547 20637547 Operation CPAP CPAP P Supp CPAP CPAP P Supp Continuous Positive Airway Pressure Pressure Support Spontaneous breathing at a raised pressure level in order to increase the functional residual capacity FRC Spontaneous breathing can be augmented with additional pressure
11. Touch screen key for the desired time scale The key turns green and the selected time scale is now in effect Display a value in the trend for a certain point in time Turn dial knob to position the cross hair cursor over the desired point in time The value is displayed on the left beside the F screen key Touch x screen key to close the trend display Operation Displaying Trends 1 24 hr SIMV AutoFlow Pmean PEEP Q 10 5 Mi Values A ES e Main Yol FiO Special 35 Data x Limin MV Procedure Values Logbook frs 5 15 20 Limin 4 i oe n a E Limin MV spn i MVspn 00 PEE 0 bpm E i 10 bo PET fotar bd 10 Euros esso 4g mH2O Ppeak 28 bh i 450 DEE i PT 2 39 8 39 8 39 lmT 2 lie Int SIMV AutoFlow Pmean PEEP 1 O 23 Fee MU ves m 10 5 EE e Main Vol FiO Special Data Values Logbook Trends 35 MV Procedure x Limin Ppeak f Ve VTPSupp RSBi Pot PEEP 10 fspn Ppeak Time scale h 4 5 vis a Umin MVspn 40 bpm fiota 0 0 1 0 i Vii 28 be 450 8 39 w E 63 Ext 3l Int 105 13037547 13137547 Operation Special Functions Special Functions Nebulizing aerosols During ventilation in adult mode Applicable in every ventilation mode EvitaXL applies pharmaceutical aerosols synchronized with inspiratory flow while maintaining a constant minute venti
12. Ventilator rate f Time Tinsp O2 concentration O2 Positive end expiratory pressure PEEP Pressure support PSupp Pressure rise time Slope Inspiratory pressure Pinsp may be reduced to PEEP level The ventilation pattern then corresponds to CPAP or CPAP PS NOTE Inspiratory pressure Pinsp is set as an absolute value Pressure support PSupp is set as a value above PEEP level 78 Paw fast rise time slow rise time ASB pressure assist fast slow rise time rise time Flow without spontaneous breathing t Trigger window for insp and exp synchronisation with spontaneous breathing cmH20 Limin Adult PCV O Pee PEEP 125 Freeze M vawes gm 10 5 ES e Main Vol 96 FiO Special 35 MV Procedure 4 5 Vs Data Flow da Limin e O2 Apnea vent On VT pnes 480 fapnea 12 L min MV spr 25 E 0 Ventilator Settings 2 4 x bom Flota SIMY CMY PCY CPAP Ps APRY more E 1 i I 10 Basic L Vri settings 450 settings 2 ae ue igi 2 65 Ext fl Int 00837547 10937547 pa Sn L Xera suononasu 8unejedo Operating Instructions EvitaXL 1 US ed To set Touch the respective screen knob Turn dial knob to adjust setting Press dial knob to confirm setting To view additional text information on PCV and PCV P Sup
13. compliance with the measuring accuracy therefore cannot be guaranteed for spontaneous breathing R values may be considerably biased as spontaneous breathing increases compliance with the measuring accuracy therefore cannot be guaranteed for spontaneous breathing 184 pa Sn Lb Xera suononasu 8unejedo Operating Instructions EvitaXL 1 US ed Negative Inspiratory Force NIF Range Resolution Accuracy Waveform displays Airway pressure PAW t Flow t Volume V t Exp CO2 concentration FCO2 Monitoring Expiratory minute volume MV Upper alarm limit alarm Setting range Lower alarm limit alarm Setting range Airway pressure PAW Upper alarm limit alarm Setting range Lower alarm limit alarm Insp O2 concentration FiO2 Upper alarm limit alarm Lower alarm limit alarm Range End expiratory CO2 concentration etCO optional Upper alarm limit alarm Setting range Lower alarm limit alarm Setting range Technical Data Monitoring 45 to 0 cmH2O 1cmH20 2 cmH20 10 to 100 cmH2O 150 to 180 L min O to 2000 mL 0 to 100 mmHg or O to 13 kPa or O to 13 Vol if MV exceeds the upper alarm limit 41 to 0 1 L min in 0 1 L min increments if MV falls below the lower alarm limit 0 01 to 40 L min in 0 1 L min increments if the Paw high value is exceeded 10 to 100 cmH20 if the value PEEP 5 cmH20 linked to set value of PEEP is not exceeded for at least 96 ms in 2 successive ventilato
14. gt Mand Mand insp exp Spontaneous breathing Spontan breathing Flow Mand IMana insp lexp Spontan breathing Spontaneous breathing 89 01537547 Operation ATC To set Touch Add settings screen key in the respective ventilation mode EvitaxL displays the possible supplemental settings Touch ATC screen key EvitaXL displays the menu for setting automatic tube compensation Select tube type Touch ET or Trach screen key respectively Touch ID screen knob turn dial knob to set value press dial knob to confirm Touch Comp screen knob turn dial knob to set value press dial knob to confirm To activate deactivate ATC Touch On or Off screen key respectively then press dial knob to confirm EvitaxL indicates activated tube compensation by showing a tube symbol and the tube diameter in the status line When tube compensation is activated EvitaxL calculates tracheal pressure on the basis of the selected tube regardless of the degree of compensation selected This value is then displayed as a green line in the pressure waveform together with the pressure at the Y piece 90 Pressure at Y piece P Tracheal pressure e Y emH20 G 5 A 10 5 Wi vaves s a 2 a Main Vol FiO 35 Da
15. 0 0 95 0 50 sensor Follow device instruction manual b fi il pm total Eg m nm Calibration z ad Reset m Resetting CO calibration Cal Vn Reset calibration data press Reset Cal 15 and confirm EN igi gt m 63 Ext lir Int LL o lt lt N 14037547 04837376 pa Sn L Xera suononasu 8unejedo Operating Instructions EvitaXL 1 US ed Touch the respective screen knob Turn dial knob to enter the concentration If the calibration gas consists only of CO2 and N2 set the O2 and N20 concentrations to O Touch Start screen key During calibration the following message is displayed on screen CO2 calibration Please wait EvitaXL performs the calibration and confirms with the message CO2 calibration ok The ventilator indicates a failed calibration with the message CO calibration interrupted or CO calibration not ok Repeat calibration of the CO2 sensor Resetting CO calibration If calibration with calibration gas was unsuccessful the factory set calibration value may initially be used In the menu CO2 Touch the screen key Calibration Touch the screen key Reset Cal Calibration will be reset after approximately 5 seconds and the factory set calibration value is reactivated e Perform a valid calibration as soon as po
16. Disconnect patient from the ventilator and continue ventilation immediately with another independent ventilator Use PEEP and or elevated O2 concentration as necessary Call DraegerService High frequency Patient is breathing at a high spontaneous rate Check patient condition Check ventilation pattern Correct alarm limit if necessary ILV Sync inop Message on both ventialtors during ILV Tm Frequency on master ventilator less than 4 breaths per minute Set a higher breath rate Fault in communication between the ventilators Ventilator functions are not affected but there is no communication between the two units Replace ventilator to continue use of ILV Call DraegerService Insp hold interrupted The Insp hold key was held down longer than 15 seconds Release Insp hold key Internal battery discharged The ventilator is being powered by its integrated DC battery due to the absence of AC line power or an external battery The time for operation with power from the integrated battery has expired Connect ventilator immediately to AC line power or to a fully charged external battery Internal battery in operation The ventilator is being powered by its integrated DC battery due to the absence of AC line power or an external battery The maximum time for operation with power from the integrated battery is 10 minutes Connect ventilator to AC line power or
17. Limin Paw Freeze a ph Flow CE Ventilator Settings Pcv I I A Overview ATC Apnea ventilation Flow Auto trigger Flow 25 0X Apnea ventilation EA T Basic settings Add settings SIMV Pinean PEEP 10 5 vol FiO 35 Limin MV 4 5 m Limin MV spn 0 bpm fiota 10 Adult Mi Values e Main Data Special Procedure ES Ext Int 02937547 19237547 pa Sn Lb 1Xe3 suononisu 8unejedo Operating Instructions EvitaXL 1 US ed To terminate Apnea Ventilation Press the Alarm Reset key the ventilator will resume operating in its previous ventilation mode or select another ventilation mode Operation Apnea Ventilation 87 Operation AutoFlow AutoFlow for automatic control of Insp Flow and Pinsp AutoFlow is used by the EvitaXL to decelerate and control inspiratory flow by providing a constant pressure throughout the inspiratory phase The ventilator determines the lowest peak pressure for the selected VT and the patient compliance thereby avoiding pressure peaks EvitaxL delivers additional inspiratory flow when the patient breathes in this flow is limited by the set alarm limit Vti The patient can also breathe out during the inspiratory plateau phase Inspiratory pressure is limited by the alarm limit Paw WARNING Always set the ala
18. Xera suononasu 8unejedo Operating Instructions EvitaXL 1 US ed Use of the Power Sources Operation is possible with either of the following configurations Integrated battery only with and without AC line power Integrated battery and external battery with and without AC line power EvitaXL draws its electric power from one of the following sources in the order of priority listed 1 AC line power 2 External battery 3 Integrated battery The changeover between these supplies is performed without interrupting operation according to the following rules If sufficient AC power is available the AC power source is always used If sufficient AC power is not available and a sufficient voltage is present at the DC socket EvitaxL will be powered by the external battery No alarm message accompanies this switch to external battery power If sufficient AC power is not available and there is no DC power available at the DC socket e g with a discharged external battery EvitaXL will be powered by the integrated battery In order to make use of as much power as possible the ventilator switches back from the integrated battery to the external battery if it has recovered This function is only intended for use in emergencies and may lead to a deep discharge of the battery The operating ventilator must be run on AC power or a fully charged external battery as soon as possible NOTE While ru
19. replace if necessary Ventilator malfunction Disconnect patient from the ventilator and continue ventilation immediately with another independent ventilator Use PEEP and or elevated O2 concentration if necessary Call DraegerService MV low alarm off Only in application mode Mask NIV Monitoring of the lower alarm limit for the minute volume has been deactivated in NIV application mode Set alarm limit MV to the required value again 170 pa Sn L Xera suononasu 8unejedo Operating Instructions EvitaXL 1 US ed Troubleshooting Message Cause Remedy Nebulization interrupted Only in pediatric mode Nebulizing is only possible in pressure controlled ventilation or with AutoFlow Change patient mode Restart nebulizer Acknowledge alarm with Alarm Reset Only in pediatric mode only for ventilation with AutoFlow Flow sensor not ready for measurement Switch flow monitoring on or calibrate flow sensor see page 116 or replace flow sensor or change mode Restart nebulizer Acknowledge alarm with Alarm Reset Nebulizer on The nebulizer is switched on see page 106 Switch off nebulizer off if necessary see page 106 O2 measurement inop n O2 sensor provides invalid measured values Calibrate O2 sensor see page 119 replace if necessary O2 measurement malfunction Ventilation may be continued use external
20. Diag nostics Inspiratory Hold Expiratory Hold touch and hold touch and hold Nebulizer Suction procedure Tar Oat suction Yol bpm 4 0 5 MOL vaues Operation Special Functions PEEP 122 e Main FiO Flota 63 Ext Int 111 20437547 Operation Special Functions Expiratory Hold This function may be used in all ventilation modes Used for determining the measured NIF value for weaning Touch the function key SIMV Special Procedure PNIS EvitaxL displays the menu Additional Function ETE i PEEP aiv e Touchandhold Exp hold screen 10 5 key for the desired expiratory time Vas EOS Sou The ventilator will end expiration after a maximum of 15 seconds i Flow i 50 Limin dn L min Joc To view additional text information 25 Touch screen key y Vis To quit the menu Special Procedure EXA bem fits Touch x screen key Additional Diag Function nostics 1 0 Inspiratory Hold pan AAT Nebulizer m L Vri E touch Sucti d pr Expiratory Hold Hold and hold uction procedure suction E p 15 zi 65 Ext 3i Int For displaying NIF see page 115 For a detailed description of NIF see page 213 112 20537547 pa SN EL Xera suononasu Burejed o Operating Instructions EvitaXL 1 US ed Diagnostic Functions Occlusion pressure P O 1 O
21. Supplementary function allowing ventilation pressure in the patient circuit to be increased during inspiration and to be decreased during expiration Airway pressure is adjusted to the tracheal level if 100 compensation of the tube resistance has been selected Automatic tube compensation is active during spontaneous breathing pressure supported breathing pressure controlled mechanical ventilation volume controlled mechanical ventilation with ventilation mode extension AutoFlow activated Expiratory tube compensation may be independently deactivated In volume controlled ventilation modes with constant inspiratory flow CMV CMVassist SIMV MMV automatic tube compensation is only active during expirations following mechanical breaths and phases of spontaneous breathing Parameters to be set for ATC Tube mode ET endotracheal tube or Trach tracheotomy tube Inside tube diameter ID O in mm Degree of tube compensation Comp in 96 Tube compensation On Off Please refer to page 209 for a detailed description of ATC Operation ATC Example SIMV Tube comp deactivated Paw 4 Tube comp activated active inactive gt PEEP gt Mand Mand Mand Mand t insp pe insp pe FlowA Spontaneous Spontaneous breathing breathing Example BIPAP Tube comp deactivated Tube comp activated active
22. emH20 Freeze 40 m Lt 20 En EN 22 D 10 go min Flow g gr 25 o 25 50 Ventilator Settings 4 X n Hew A OPAPP S17 es ues P Flow Auto h Overview ATC trigger Fla Sigh Off On On Off settings 60 96 7 Limin PEEP ET Tube 10 cmH20 8 0mm CMV AutoFlow assist Pmean PEEP iii d TORES O Main Vol 96 FiO2 35 Wisin my Procedure 4 5 s Limin MVspn bpm frota ES Ext 3i Int Overview ATC Flow Auto sy trigger Flow pru go P H20 Paw Freeze 40 Pu Le 20 EN E ES 0 10 50 Limin Flow az 25 0 25 50 Ventilator Settings OK m CMV PCY baba pue Flowtrigger EB 0 Trigger settings CMV AutoFlow assist Pmean PEEP 122 10 5 100 Values e Main Yol FiO Special Data 35 MV Procedure 4 5 Vp Umin MV spn 0 bpm Flota Li min 63 Ext Int 10537547 10637547 pa SN L 1Xe1 3 suononujsu Bueaedo Operating Instructions EvitaXL 1 US ed Flow trigger for synchronization with a patient s spontaneous breathing efforts When the flow trigger is activated and a trigger level is set mandatory ventilator breaths are synchronized with the patient s spontaneous breathing efforts The patient s spontaneous breathing activity by is indicated on screen by the brief appearance of a lung symbol instead of th
23. mode Depending on the selected patient mode EvitaxL compensates for leaks up to the following values in order to detect a patient trigger Adult mode 30 L min Pediatric mode 15 L min EvitaXL compensates for calculated leaks of up to 200 96 of the set tidal volume but not more than max 2 L regardless of the patient mode Operation Using NIV 95 Operation Setting Alarm Limits Setting Alarm Limits Press key Alarm Limits EvitaxL displays the Alarm Limits menu Upper alarm limit z Lower alarm limit The values for the upper and lower alarm limit shown in the screen keys are initial values which are in effect whenever the ventilator is switched on However these defaults can also be configured specifically as required by hospital protocol see Configuration page 143 The actual measured value is displayed between the upper and lower alarm limits To set Touch the respective screen key it will turn yellow turn dial knob to set press dial knob to confirm Alarm limits for the optional measured value etCO2 can be viewed by touching Limits 2 Touch Limits 2 screen key To deactivate MV for example Reduce MV until the following advisory message is displayed MV off Press and turn rotary knob Press dial knob to confirm the advisory message Continue turning dial knob until dashes appear on the display for
24. 0 0 255 11 Resistance R mbar L s 0 0 200 12 pont minute volume S min 0 00 99 99 13 Spont frequency fs 1 min 0 240 14 Airway Temperaturee Temp deg C 18 45 15 Intrinsic PEEP Pintr L min 0 0 99 99 16 Trapped Volume Vtrap mL 0 9999 17 Occlusion Pressure P01 mbar 0 0 99 9 18 nd tida 2 in mmHg 2E1 mmHg 0 99 19 End tidal CO2 in kPa CO2E2 kPa 0 0 99 9 20 End tidal CO2 in CO2ES 0 0 99 9 21 CO2 Production CO2P mL min 0 999 22 Dead Space Vds mL 0 999 23 Rel Dead Space Vds 0 999 4 SpO2 Spo2 0 40 25 Puls Puls bpm 0 999 26 Tidalvolume ASB VTASB mL 0 9999 27 Negative Inspiratory Force NIF mbar 45 0 28 Rapid Shallow Breathing RSB 1 L min 0 9999 Leading zeroes identified by 0 0 or 0 in the table are replaced by one or two blanks Technical Data Data Protocols 193 Technical Data Data Protocols End of telegram EOT Status telegram The status telegram contains all settings alarm limits ventilation modes and status messages It has the following structure Telegram header SOH Start character 050 Identification number 0 Channel number Telegram body The body of the telegram contains any number of status messages each separated by GS Each status message consists of a number and a name GS number of the status message message text Data such as settings and alarm limits are enclosed between FS in the status message All status messages are listed
25. Apnea ventilation SOWING 45i v a EE deett 86 Application mode tube mask oxi aer Sei i eere 51 APRV description aix rax eet ae ee etd es 205 ASCII characters used eee 222 ATC description ui etre ettet em ete e Rs 209 setting aia barata 89 technical data s cece eee eee 181 AutoFlow description oi yraa a a et 199 setting dormir GU pr eee ete 88 B Back panel layout oooooccccccncncnnnnnccccc 176 Batteries charging 3d deter deri dau 55 Battery charge iii daa d etn 56 charge indication ccc cece eee 56 ChargingGtiMes 2 2 rode tempe tte wt 56 cormect disposal 2o vedere tera 161 external Mirian yd pede teens 57 60 Integrated iic erbe tee eite te acs 59 maintenance ssss nnn 56 Bibliography cr deisen e rr RR denn 221 Body fluids culinarias 16 146 226 C Calibration Siria a or c as 116 Care E 146 Cleaning as e draga ot deese darius is sateen dees ds 150 Clock realtime 0000000000 iria e ned oe ats 159 CMV SettlDng ii ed us itte te heer eapite 67 CO2 calibration resetling esu Sas uiu mei ri eR au ekIPMER 125 with calibration gas eee eee eee 122 with test filter oooooooooooonooooo o m o 121 ZOOMING ero 120 CO2 sensor Calibration 252a edes rnnt Wena canada te 119 disinfecting iid gr taf attt Rona ae s 151 cnr it We ia arate stk aus 146 Components removing idi donem ers a o i 146 Components assembly of 35 Config
26. FS nnn FS 96 83 O2 saturation low limit FS nnn FS 96 Ventilation modes 30 Mode IPPV 31 Mode IPPV ASSIST 34 Mode SIMV 35 Mode SIMV ASB 38 Mode CPAP 39 Mode CPAP ASB 40 Mode MMV 41 Mode MMV ASB 42 Mode APRV 438 Mode SYNCHRON MASTER 44 Mode SYNCHRON SLAVE 45 Mode Apnea ventilation 48 Mode BIPAP 49 Mode BIPAP ASB 60 Mode SIMV AutoFlow 61 Mode SIMV ASB AutoFlow 62 Mode IPPV AutoFlow 63 Mode IPPV ASSIST AutoFlow 64 Mode MMV AutoFlow 65 Mode MMV ASB AutoFlow 66 Mode ASYNCHRON MASTER 67 Mode CPAP PPS 68 Mode BIPAP ASSIST 69 IV Invasive ventilation 70 NIV Non invasive ventilation pa Sn i Xera suononasu 8unejedo Operating Instructions EvitaXL 1 US ed Status messages 24 Flow monitoring on 24 Flow monitoring off 50 Audio alarm inactive on 50 Audio alarm inactive off 51 Nebulizer on 51 Nebulizer off 53 O2 calibration on 53 O2 calibration off 54 O2 monitoring on 54 O2 monitoring off 55 Suction on 55 Suction off 56 Flow calibration on 56 Flow calibration off 57 CO2 calibration on 57 CO2 calibration off 58 CO2 monitoring on 58 CO2 monitoring off 85 SpO2 monitoring on 85 SpO2 monitoring off 97 Neonatal 98 Adult 99 Pediatric End of telegram EOT Data telegram The actual measured values define
27. Keys Flow Custom Service 45 0 15 v Data y coz Pleth Lock lmT gt 63 Ext Aii Int 131 14837547 14937547 Configuration Specific System Settings Defining initial measured values O Press E System Setup key Touch Screen screen key Touch Values screen key EvitaxL displays the menu for compiling the selection of essential measured values defaults and their effective alarm limits The screen keys are arranged in the same order as the numerical values on the main screen Three sets with six values each can be combined For specifying the parameter selection in the three sets Inthe respective set Group 1 II Group 2 or BGroup 3 touch screen key for the line concerned The key turns yellow An additional menu is displayed For choosing between one or two parameters in each line For selecting the parameter e Touch 1 Value or 2 Values Screen key to select one or two parameters per line Turn dial knob to select parameters from the list press dial knob to confirm 132 Freeze ta PE 20 0 10 System Setup x System Ventilation Configure groups of measured values displayed on main page oia Overview 10D Group 1 DIO Group 2 DON croup 3 Sound Pmean PEEP vr PEEP Graphics Day Night Screen FiO2 MVspn Mv Values pi MY PEEP MVspn Trends Country ji Interface MVspn Pmean Pmean E
28. The duration of Pinsp is rather determined by Tinsp Spontaneous breathing is possible at any time during ventilation Each recognized inspiratory effort by the patient will trigger a synchronized inspiratory cycle The ventilator will start an non synchronized inspiratory cycle at the latest after the inspiratory time fixed by f and Tinsp has elapsed 204 mandatory BIPAP stroke spontaneous breathing synchronisesd BIPAP stroke trigger window spontaneous breathing time gt Paw fast PEEP Flow without spontaneous breathing rise time slow rise time Tinsp Trigger window for synchronisation with spontaneous breathing 02237547 00937547 pa Sn L 1Xe3 suononysuj 8unejedo Operating Instructions EvitaXL 1 US ed APRV Airway Pressure Release Ventilation Spontaneous breathing under continuous positive airway pressure with brief pressure release This ventilation mode is suitable for patients with a poor gas exchange The patient breathes spontaneously at a high pressure level Phigh for an adjustable length of time Thigh For very short expiratory times Tlow EvitaXL switches to a low pressure level Plow The normal lung areas are emptied but the slow lung areas only change volume to a lesser extent In this way the ventilation perfusion ratio can be improved for patients with a poor gas
29. The key turns yellow Press dial knob to confirm The key turns green Display on the screen Park CO2 sensor Press dial knob to confirm 1 Remove CO sensor from the cuvette and 2 place sensor on its park bracket Confirm with dial knob EvitaXL now performs the zeroing of the CO2 sensor Display CO2 zero calibration After about 5 seconds the ventilator confirms with the message CO2 zero ok 1 Push sensor back onto the cuvette 120 cmHaO Paw 60 Freeze EB Monitoring When switching the monitor ta Off it must be replaced by external monitoring Calibration 40 a gwe 20 0 10 Sensor Parameter x Flow 02 coz Zero calibration SE Zero Manual calibration required Ion TN If the CO2 curve no longer returns to Check zero after each inspiration sensor Press Vol 96 Limin L min bpm lli Int PEEP 123 10 5 Wi Values e Main FiO Data Special 35 MV Procedure 4 5 OE MV on 0 10 2 Ext 14237547 04337376 04437376 pa Sn L 1Xe3 suononsysu 8unejedo Operating Instructions EvitaXL 1 US ed EvitaxL will indicate a failed zero calibration with the following message CO2 zero See Troubleshooting page 164 Repeat CO zero calibrati
30. The remaining time is counted down continuously To cancel the oxygenation program Touch O2 suction screen key To view additional text information on oxygen enrichment Touch screen key To quit the menu Touch x screen key 110 pa Sn Lb Xera suononasu 8unejedo Operating Instructions EvitaXL 1 US ed Manual inspiration Inspiratory hold This function may be used in all modes except in CPAP without Pressure Support Regardless of the start time an automatic ventilator breath can be extended for up to 15 seconds Or Between two automatic ventilator breaths a ventilator breath may be manually started and held for max 15 seconds The pattern of the manually started ventilator breath corresponds to the ventilation pattern of the currently active automatic ventilation mode In CPAP P Supp a pressure assisted ventilator breath defined by the PSupp setting is triggered e Touch Special Procedure screen function key EvitaXL displays the menu Additional Function Touch and hold the Insp hold screen key for the desired duration of inspiratory time The ventilator will end inspiration after a maximum of 15 seconds To view additional text information Touch screen key To quit the menu Touch x screen key 25 50 60 emH20 Lmin Freeze Flow AA Qe Special Procedure Additional Function
31. Vent flow sensors after disinfection with ethanol for at least 30 minutes 116 pa Sn Lb Xera suononasu 8unejedo Operating Instructions EvitaXL 1 US ed O Press S Sensor Parameter key The Sensor Parameter menu is displayed with the Flow menu Flow monitoring is now active Start calibration Touch Start screen key The key turns green and EvitaXL calibrates the flow sensor The next inspiratory phase is used for the calibration process Short inspiratory times are extended to approx 1 second Display on the screen Flow calibration The Start screen key turns pale green when calibration is complete External flow compensation When a constant external flow of up to 12 L min is supplied e g when using a nebulizer with external gas supply EvitaxL is able to take this flow into account and to increase the thresholds for flow sensor monitoring This helps to avoid Flow measurement inop alarms during these applications The originally measured expiratory volume is maintained during expiratory flow EvitaxL will therefore measure a correspondingly higher value for VTe and MV To avoid alarms Adjust upper limit for MV Operation Sensors go MH20 Paw 40 a Lt 20 o 10 Sensor Parameter x Flow 02 coz Calibration EI Manual calibration required After exchanging flow sensor Monitoring off When switching the monitor to Off it must be replaced
32. fast rise time assist slow rise time Flow Insp flow o Trigger window 60 emH20 Limin F Freeze A Qt low Ventilator Settings ZH POV I Tiitii pee i in f Apnea vent On VT pnea 480 yi f pnea 12 4 Slope Flow PEEP Psupp 9 6 S C Basic settings Add settings 9 Adult SIMV Prean PEEP 123 10 5 Wi Values e Main Vol 96 FiO 35 Data Special Lmin MV Procedure ZONE i Y 20 Limin MV spr 0 bpm Flota 10 450 65 Ext Int E 69 00637547 10837547 Operation SIMV SIMV PS To view additional text information on SIMV SIMV PS A Touch screen key SIMV SIMV PS can be supplemented to include the following ventilation mode extensions Flow trigger page 85 Apnea ventilation page 86 AutoFlow page 88 Automatic Tube Compensation ATC page 89 Pressure Limited Ventilation PLV page 92 These functions can be enabled via Add settings NOTE For setting alarm limits see page 96 70 pa Sn Lb Xera suononasu 8unejedo Operating Instructions EvitaXL 1 US ed MMV MMV PS Mandatory Minute Volume Ventilation Pressure Support The overall minute volume is preset to a mandatory level which can be adjusted via tidal volume VT and ventilator rate f The patient can breathe sponta
33. for PEEPi in larger characters with time date in the left hand column The value of the previous measurement is shown in the right hand column Along with these measured values the respective set values of PEEP are displayed To start measurement of PEEPi Touch Start screen key the key turns yellow O Press dial knob to confirm the screen key turns green and EvitaXL starts measurement of the value for PEEPi To view additional text information Touch screen key To quit the menu Touch x screen key Please refer to page 214 for a detailed description of Intrinsic PEEP 114 Freeze A Qe Special Procedure Additional Function Diag nostics Intrinsic PEEP Start PEEP set PEEP Virap Time Date 0 cmH20 0 OL 09 32 09 08 2001 PEEPi set PEEP Virap Time Date 0 cmH20 49 OL 08 31 09 08 2001 Vol FiO bpm fita iy Vri 450 7 igi gt 65 Ext 3i Int 13637547 pa Sn Lb Xera suononasu 8unejedo Operating Instructions EvitaXL 1 US ed Negative Inspiratory Force NIF The Negative Inspiratory Force index NIF measures a patient s maximum effort at inhalation after prior exhalation This value is also known as Maximum Inspiratory Pressure MIP The patient circuit is closed during measurement of NIF As a result of the inhalation effort during a manually extended
34. polysulphone polysulphone silicone rubber polyamide silicone rubber and aluminum polysulphone with glass windows silicone rubber polyurethane Nurse Call Available Option Pin assignment 6 pin round DIN socket Floating DC contact Input voltage max 40V Input current max 500 mA Switching capacity max 15 W 188 pa SN i Xera suononasu 8unejedo Operating Instructions EvitaXL 1 US ed Ventilator Outputs Digital outputs COM 1 plus COM and COMG optional can be configured for Pin assignment of the MEDIBUS cable Pin assignment of the printer cable Cable length Load impedance Signal level for load impedance from 3000 to 7000 ohm Low High Technical Data Ventilator Outputs LUST protocol Baud rate 1200 2400 4800 9600 19200 Baud Data bits 7 Parity even Stop bits 1 MEDIBUS protocol Baud rate 1200 2400 4800 9600 19200 Baud Data bits 8 Parity even odd no Stop bits 1 or 2 19200 baud are required for transmitting high speed data e g for displaying flow waveforms Printer protocol HP Deskjet series 500 Baud rate 1200 2400 9600 19200 Baud Data bits 8 Parity no Stop bits 1 EvitaXL GND GND 5 NEM 5 TxD RxD 3 BEEN C 2 RD TxD 2 mE C 3 9 pin sub D 9 pin sub D connector Connector housing socket EvitaXL 5 GND GND m E 7 3 TxD RxD mum EE 3 2 RD i TxD mum C mm 9 pin sub D 25 pin sub
35. the alarm limit Press dial knob to confirm 96 Limits pi 10 50 Limin Flow aum gt 25 0 25 50 Alarm Limits x MV F MEX 45 y ES Limin Paw 28 emH20 Vr hs 450 bpm Limits 2 L Limits 1 SIMV AutoFlow Pmean PEEP TES Yol FiO 35 L min MV 4 5 VE L min MV spr 0 bpm fitu 10 A50 EE k Y s 12 Mi Values e Main Data Special Procedure 63 Ext Int go H20 Paw DM o E MEOS EN e 40 Pu Lt 20 B 2 el 0 10 50 Limin Flow aum prz 0 25 50 Alarm Limits x Limits etCO Limits 1 A 35 oe mmHg SIMV AutoFlow Pinean PEEP 10 255 Vol 96 FiO 35 Limin MY 4 5 ERE L min MV 0 bpm frota 10 Vri A50 EE k Y 123 100 Values e Main Data Special Procedure 63 Ext Int 11137547 16737547 pa Sn L Xera suononasu 8unejedo Operating Instructions EvitaXL 1 US ed In the Event of an Alarm 1 A message corresponding with the alarm event is displayed in the top left hand line of the screen Example Tidal volume high EvitaXL assigns the alarm message its respective priority accordingly marks the text with exclamation marks and differently colored backgrounds and generates the corresponding alarm tone sequences Warning top priority message Warnings are identified by
36. trailing towards the ventilator 41 07237547 08037547 07337547 Preparation Ventilating Infants and Small Children 1 Insertthe plug of the CO2 sensor in the CO2 socket on the rear panel of the EvitaXL Ventilating Infants and Small Children Up to 300 mL tidal volume VT Patient mode Pediatrics WARNING Do not use a heat moisture exchanger simultaneously with a nebulizer or heated humidifier Risk of increased breathing resistance due to condensation Installing an inspiratory bacteria filter 2 Place bacteria filter on inspiratory port 42 O gt Dr ger m S E x ES 08137547 08237547 pa SN L Xera suononusu 8unejedo Operating Instructions EvitaXL 1 US ed Preparation Providing Electrical Supplies and Connections Installing an infant patient circuit WARNING To avoid any risk of electric shock in the event of faulty grounding of patient monitoring equipment do not use antistatic or electrically conductive patient circuits Prepare the humidifier following its Operating Instructions using infant size patient circuit c
37. 18 measured values can be compiled The screen keys reflect the position and order of the measured values in the customized table Touch each successive screen key It turns yellow and a selection list appears beside the keys Select and confirm with the dial knob To configure the settings Touch Settings screen key EvitaXL displays a table with a maximum of 15 settings Configure settings as described above for the measured values Configuration Specific System Settings SIMV AutoFlow Pinean PEEP 123 Freeze 1 0 5 Mii vaues ES el e Main Vol 96 FiO Data Z 35 Special Procedure System Setup min MV System Ventilation 5 4 15 z Y 20 m Limin MV spn verview Configure measured values for customized table Measured Overview tae Values Sound 0 Pret R v 8eraphics Day Night Settings f d bpm total Screen Mr S Values o 10 ris Trends Country Pmean FiO2 mem Interface L Vri Keys Pplat Pmin Custom Service 45 0 15 Data x y PEEP Lock Tz D I5 63 Ext lil Int SIMV AutoFlow Prnean PEEP 123 Freeze 1 0 5 Mii ves EZ el e Main Yol FiO 35 Data Special y Procedure System Setup X umn MV System Ventilation 4 5 15 Y 20 Em Limin MV spn verview Configure settings for customized table Measured Overview Pond Values Sound 0 Mode 02 PEEP Graphics Day Nigh
38. 8unejedo Operating Instructions EvitaXL 1 US ed Troubleshooting Message Cause Remedy Airway pressure low WW Leaking cuff Inflate cuff and perform leak test Leak or disconnection Check patient circuit for tight connections Check that the expiratory valve is properly engaged Ambient pressure sensor Ambient pressure sensor faulty Ventilator functions are not affected However the ventilator must not be used in aircraft or helicopters Call DraegerService Apnea Patient s spontaneous breathing has stopped Apply controlled ventilation Stenosis Check patient condition Check tube Flow sensor not calibrated or faulty Calibrate flow sensor Replace if necessary Apnea alarm off Only in Mask NIV application mode Apnea monitoring has been switched off in application mode NIV Set upper alarm limit for apnea monitoring to the desired value again Apnea ventilation Due to detected apnea the ventilator has automatically switched to mandatory ventilation Check ventilation mode selected Return to the original ventilation mode with Alarm Reset Check patient condition Check tube Breathing cycle not detected The ventilator is not delivering any gas Set Pmax higher than PEEP setting Extend alarm time TApnea or increase CMV ventilator rate Device faulty Disconnect patient from the ventilator and con
39. En D L min MV spr 25 50 0 Turn dial knob to adjust setting MMV MMV PS can be supplemented to entlster Settings NN ie include the following ventilation mode R po ooouA a 10 E 66060020 Flow trigger page 85 AutoFlow page 88 5 b te 450 ie Automatic Tube Compensation izi E ATC page 89 Flow PEEP Psupp cell x 11037547 Pressure Limited Ventilation PLV page 92 These functions can be enabled via Add settings NOTE For setting alarm limits see page 96 72 pa Sn Lb Xera suononasu 8unejedo Operating Instructions EvitaXL 1 US ed Operation ILV ILV ILV Independent Lung Ventilation Synchronized independent ventilation of the two lung sides with two Evita ventilators that are connected via analog interface The two ventilators are operated in master slave mode with the master ventilator controlling ventilation Preparation for ILV The following device combinations are possible EvitaXL with EvitaXL EvitaxL with Evita 4 EvitaxL with Evita 2 dura Requirements for combinations EvitaXL or Evita units must be CN equipped with the EvitaBus analog wo interface available option Interface cable part no 84 11 794 must be used to connect EvitaxL to
40. Ext Int RE Oz 700 x Curves Loops Trends Freeze 500 Left Right Pu ejas Flow P aw Paw V 300 Single V Flow V CO2 V Flow V CO2 Den 100 Large Ref 0 Ptra V Flow Ptra Pirs V Flow Ptra 10 0 20 40 cmH20 Fl 50 Limin low pan Lt E 0 25 y 50 V 7004 ym Le 500 300 100 0 r 0 2 4 6 8 10 12 14 16 sec Apnea vent On MORAS o Qo e Q Q PEER Psupp Yol Limin L min bpm 35 4 5 s 0 Special MV Procedure MVson flotas E3 Ext Int 13237547 12237547 pa Sn L 1Xe3 suononasu 8unejedo Operating Instructions EvitaXL 1 US ed Operation Displaying Graphics To display small loops Press Small screen key To display a large loop Press Large screen key Select the desired parameter combination Touch screen key for the desired parameter combination A list of possible combinations is displayed on the screen Select and confirm parameter combination with the dial knob All loops for a breath cycle are recorded by the ventilator In SIMV mode this will include e g both the loop for a mandatory ventilator breathas well as the loop for a spontaneous breath if any To display a single loop Touch the screen key Single breath EvitaXL will redraw every single loop c Paw V 50 min V Flow pan PEEP 123 Freeze 1 0 5 Mii vaues To display a r
41. Humidifier WARNING Draeger cannot warrant or endorse the safe performance of third party humidifiers that are not described in this manual for use with the EvitaXL ventilator Specifically the user must assess the risks of delivery of breathing gas not maintained at a proper temperature associated with different humidifier designs We strongly recommend using the electronic temperature monitoring feature of the ventilator if no proximal airway temperature monitoring is performed by the humidifier used Increased pneumatic resistance in the inspiratory line caused by a humidifier may result in less accurate airway pressure readings We recommend contacting the manufacturers distributors of third party humidifier devices about compliance of their products with the requested performance characteristics 1 Attach humidifier to mount below ventilator with rail clamp and secure clamp mechanism screws lever 2 Swivel humidifier into desired position Prepare humidifier following its Operating Instructions Depending on the position of the ventilator in relation to the patient bed the hinged circuit support arm can be mounted to either side of the ventilator 3 Turn expiratory port to the left or right respectively left showing 4 Attach angled circuit connector of humidifier pointing into the direction desired left showing 5 Turn inspiratory port to the right and install a bacteria filter to the port NOTE For the fo
42. Instructions EvitaXL 1 US ed Configuration Specific Initial Therapy Values Setting start up defaults for alarm limits O Press E System Setup key simy lAa Touch Ventilation screen key AutoFlow Touch Alarm Limits screen key and enter access code 3032 10 5 M vaues The current start up alarm limits are a Bie displayed E voise Fio X Data upper alarm IR e 35 x lower alarm limit CEPS SER uin my Procedure Touch the respective screen key E Verte 4 5 Set and confirm with the dial knob e ES 3 7 E QU ep d i spn Apnea min i Foe 50 50 vr 100 50 15 BEM al HE 0 s oE EN i cmH20 bpm sec ol 1 0 etCOz L Vii F 60 450 uf 30 Defaut mmng ui a Ext 3i Int Parameter Adjustment range Factory default start up value Customized start up value Draeger default J MV 0 5 to 41 L min VTA 50 0000 s Y MV 0 1 to 40 L min VT f 20 0 00 s Paw 10 to 100 cmH20 50 cmH20 2ole2zx S Nii 0 03 to 4L VTi 100 0 sese Jf fspn 5 to 120 bpm bObpm eeeeeee S TApnea 5 to 60 seconds 15 seconds ooossees etCO2 optional O to 100 mmHg 0 1 to 15 kPa 60mmHg 9kPa z etCO optional O to 99 mmHg 0 to 14 9 kPa 30mmHg 4 5kPa 4 Values set may be entered in the column Customized start up value To restore factory default settings Touch Dr ger Default screen key Press dial knob to confirm
43. Positive end expiratory pressure PEEP Operation Setting Ventilation Modes PAW Ap Pmax Jb configu PEEP rable Tinsp Te Flow A f Insp flow et 67 00537547 Operation CMV To set Touch the respective screen knob Turn dial knob to adjust setting Press dial knob to confirm setting To view additional text information on CMV A Touch screen key CMV can be supplemented to include the following ventilation mode extensions Flow trigger page 85 AutoFlow page 88 Automatic Tube Compensation ATC page 89 Sigh page 91 Pressure Limited Ventilation PLV page 92 These supplements may be enabled via Add settings NOTE For setting alarm limits see page 96 68 CMV SIMY PCY n EM peiie PP o e o Flow go cmH20 Paw Te 77 Freeze a re 50 min Flow rE gk E B g 0 50 Ventilator Settings qm xs Basic settings Press PEEP iii m alues TORES Main Yol FiO2 Data 35 Special TER my Procedure 45 5 L min MVspn bpm fita E Vri A50 El Adult Ext Int 10737547 pa Sn L Xera suononasu BuiyesodO Operating Instructions EvitaXL 1 US ed SIMV SIMV PS Synchronized Intermittent Mandatory Ventilation Pressure Support Combination of mech
44. Sn L Xera suononasu 8unejedo Operating Instructions EvitaXL 1 US ed WARNING Do not block air intake Ventilator malfunction will result WARNING Do not place containers of liquids such as infusion bottles on top of or above the EvitaXL ventilator Liquids getting into the ventilator can cause equipment malfunction with the risk of patient injury WARNING Always set the alarm limit Paw f in order to generate an alarm in the event of an increase in airway pressure with reduced compliance WARNING When using AutoFlow always set alarm limits MV and MV in order to avoid excessive or insufficient flow follo wing rapid changes in compliance WARNING Installation of the EvitaXL NIV option should only be performed by DraegerService or factory trained and authorized service personnel WARNING Precautions when using mask ventilation Never ventilate an intubated patient in Mask NIV mode n MASK NIV mode the alarm system is adapted to mask ventilation Make sure that only patients are ventilated in this mode who can breathe sufficiently on their own especially when alarms have been manually disabled When masks are used dead space increases Always follow the mask manufacturer s directions to properly deal with the increased dead space caused by the mask Apnea cannot always be detected reliably SpO2 monitoring must be use if available Avoid high a
45. Touch FJ Country screen key The current date and time are displayed in the fields Date and Time Touch screen key Set and confirm with the dial knob Configuration Specific System Settings SIMV AutoFlow Pmean PEEP 125 Bo 10 5 Wi vaves er e Main Vol FiO Data 4 so F Special System Setup X Lmin my Procedure System ventistion 4 5 15 SM S ug F Language M US English Lmin MV ipn Overview Sound 0 Pressure Temp CO2 Day Night Units cmH20 F mmHg Screen bpm fitu o 10 Coun Day Month Year ty d Date 20 06 2001 Interface L Vr 450 Hour Minute Time 15 27 Tz D 1 ES Ext E Int AutoFlow go mao Paw Press PEEP 125 a T 10 5 WM vares 40 a e Main 2 Vol FiO Data a 35 Special System Setup X Umin my Procedure System Ventilation 4 5 15 li ig I E US English ym Language Een LIS MV Sound 0 Pressure Temp CO2 Day Night J Units emH20 SE mmHg Screen opm fot 5 10 C Day Month Year Bun Date 20 06 2001 Interface Vii Service 450 y 15 Hour Minute Time 15 27 w E 6 Ext Jib Int 137 15837547 15837547 Configuration Specific System Settings Configuring the serial interface O Press FF System Setup key Touch Interface screen key Interface parameters are displayed in the field COM 1 Touch screen key of the desired interface p
46. a power failure provided that the battery is fully charged The ventilator may also be powered from an external battery via this DC power pack NOTE The integrated battery of the DC power pack will only reach its full capacity after a 24 h charge Charge internal battery for at least 24 h see Charging Batteries on page 55 Power Sources Overview Integrated battery The power pack must be removed in order to gain access to the two 12 V lead acid gel batteries integrated in the DC power pack The batteries are always supplied together with the DC power pack NOTE The integrated battery is intended exclusively for emergency use and not for normal operation Therefore after a switch to the external battery has occured immediately reestablish AC line power or DC from the external battery External batteries available option Additional rechargeable 12 V or 24 V lead acid gel type batteries may be connected to EvitaXL via the DC socket These external batteries are not supplied with the DC power pack It is advisable to use 24 V lead acid gel batteries or two 12 V lead acid gel batteries connected in series with a minimum capacity of 15 Ah The efficiency of the DC power pack and the associated duty period is significantly higher when using this type of battery than when using 12 V batteries with comparable capacity The external battery may also take the form of two 12 V lead acid gel batteries accommodated in the b
47. and or increased inspiratory O2 concentration where necessary and appropriate The unit should then be removed from use and serviced by an authorized service technician WARNING Always use extreme caution when using oxygen Oxygen intensely supports any burning No smoking no open fire in areas where oxygen is in use e Always provide adequate ventilation in order to maintain ambient O2 concentrations 24 96 Always secure O2 cylinders against tipping do not expose to extreme heat Donotuse oil or grease on O2 equipment such as tank valves or pressure regulators Do not touch with oily hands Risk of fire Open and close valves slowly with smooth turns Do not use any tools WARNING Always heed all precautions and follow all hospital protocols with respect to the administration of oxygen Make adjustments to the FiO2 according to the blood gas values measured 62 WARNING Do not block air intake Ventilator malfunction will result WARNING Do not place containers of liquids such as infusion bottles on top of or above the EvitaxL ventilator Liquids getting into the ventilator can cause equipment malfunction with the risk of patient injury Perform tests of readiness for operation according to checklist see page 46 pa Sn Lb Xera suononasu 8unejedo Operating Instructions EvitaXL 1 US ed Starting Up Switching on Push power switch button on back panel until it
48. begins with the current settings EMI US MV Ideal Body Weight E Ventilation S Tube J dm O Mask 4 Humic bpm fora Patient amp Ped wane Mer Check Vri SIMY AutoFlow vr 450 L PEEP 5 cmH20 F 15 ATC Off Tinsp 17 sec 02 36 Yol Application tube i 10 bpm Psupp B cmH20 lz D 63 Ext 3i Int 127 20237547 14537547 128 This page intentionally left blank pa Sn Lb Xera suononasu 8unejedo Operating Instructions EvitaXL 1 US ed Specific System Settings 0 eee renee eese Specific Initial Therapy Values 0 0 0 0 02 c eee eee 129 Configuration Specific System Settings Configuration For setting specific parameters for the system or therapy These initial default values are in effect when the ventilator is switched on Specific System Settings O Press E System Setup key EvitaXL displays the System Setup menu The System menu is displayed automatically with an overview of the parameters which can be set as initial values Adjusting volume of the audible alarm O Press E System Setup key Touch Sound Day Night screen key EvitaXL displays the menu for adjusting volume and day night Screen brightness Touch screen key in the line Alarm Volume Turn dial knob to adjust volume press dial knob to confirm WARNING Always adjust audible alarm volume to a level that ensures the operator will be ale
49. by Pressure Support Set the pattern of ventilation for CPAP and CPAP P Supp with the following ventilation parameters O2 concentration O2 Positive end expiratory pressure PEEP Pressure support PSupp Pressure rise time Slope To set Touch the respective screen knob Turn dial knob to adjust setting Press dial knob to confirm setting To view additional text information on CPAP CPAP P Supp e Touch the screen key CPAP CPAP Psupp can be supplemented to include the following ventilation mode extensions Apnea ventilation page 86 ATC page 89 Flow trigger page 85 These functions can be enabled via Add settings NOTE For setting alarm limits see page 96 Please refer to page 205 for a detailed description of CPAP PSupp 82 Spontaneous breathing Paw with pressure support slow rise time fast rise time Flow T gp Um H20 Paw Pmean PEEP um 10 5 oe 20 Vol FiO AAA fees m 35 50 min Flow a Lmin MV Ee 25 4 5 0 Y 290 L min MV spr 25 p 4 5 Ventilator Settings 22 x bem Flota SIMV CMY Pov BEES SENE ES 27 Basic L Vri settings 02 Slope 1 67 s Apnea vent On WTa pnea 480 fapnes 12 El PEEP Psupp ib 123 Wi Values e Main Data Special Procedure 63 Ext Int 01037547 11537547 pa Sn L X
50. by external monitoring l External Flow Compensation eo ely measure External Flow O Limin Time 1401 Date 23 08 2001 SIMV AutoFlow Presn PEEP ili xn alues 10 5 e Main WOES FiO Data 35 Special Limin my Procedure 45 5 Limin MV spn ppn Flota E Vri 450 Z gt 65 Ext d Int 117 13837547 Operation Sensors For initial calculation of the external flow Start external flow In the Flow menu Touch measure screen key the keyturns green EvitaXL measures the external flow and displays the value with date and time The following message is displayed while measurement is in progress Measuring external flow EvitaxL interrupts calculation of the external flow if it exceeds 12 L min or if the flow measurement function is faulty When the external flow has been calculated successfully it is taken into account automatically and the screen key On appears in green If the external flow is no longer applied Touch Off screen key the key turns yellow Press dial knob to confirm the key turns pale green Once EvitaxL has calculated the external flow it may be taken into account at any time Touch On screen key in the Flow menu the key turns yellow Press dial knob to confirm the key turns green If the external flow changes Touch measure screen key again and the new external flow is again calculated by Evi
51. concentration press Gas Check and compare FCO2 vyo Calibration gas mixture 0 0 95 0 02 N20 w gt m 65 Ext li Int 123 04837376 14137547 Operation Sensors Calibrating the CO2 sensor ifspecified calibration values are not met upon checking calibration with filter or calibration gas Switch EvitaxL on and wait for about 3 minutes for the CO2 sensor to complete its warm up First perform a CO2 zero calibration see page 120 then from the CO2 menu Touch Calibration screen key EvitaXL displays the Calibration menu Connect calibration gas supply Use the cuvette from the calibration set 1 Connect calibration gas cylinder and the cuvette of the calibration set to the hose 2 Remove the CO2 sensor from its park bracket and mount on the cuvette of the calibration set 3 Read CO2 O2 and N20 concentrations Vol 96 of the calibration gas from the test cylinder Calibration gas e g 5 Vol CO2 95 Vol 96 N2 Enter these concentration values with the screen knobs 124 gp Pm H20 Paw Prnean PEEP 123 AAA EE ms 1 0 5 100 Values 40 e Main 20 vol FiO2 0 Data 10 Special Procedure Sensor Parameter X Yimin MV Flow 02 c02 4 5 15 i Y 29 Calibration COz sensor Start Zero L min MV n Sensor calibration only if necessary Y i onucm Set calibration gas mixture Check 0 press gt Start lt gt
52. engages ON The protective cover will swivel over the switch button to prevent the ventilator from being inadvertently switched off The self test screen is displayed The self test is performed automatically Wait for the test to be completed The bargraph indicates the time elapsed for the self test Operation Starting Up RSS 00000000000 00000000000 A A A IA A RIII il Drager BEI Selftest version 00 00 Date 01 01 01 Part No Evita XL 63 03537376 09937547 Operation Starting Up The Start screen is then displayed Example Previous Patient Specific patient settings in effect before EvitaXL was switched off may be restored at this time including alarm limits monitoring status application status and ventilator status To restore previous settings Touch Previous Patient screen key and press dial knob to confirm The previous ventilation settings are now in effect again EvitaXL key will not display the Previous Patient screen key or will not allow to select it following a loss of data or removal of a previously used option therefore preventing previous settings to be restored in this case Similarly EvitaXL prevents restoring previous settings if the ventilator was configured in such a way before s
53. expiration the patient generates a negative pressure in relation to current PEEP The higher this negative pressure the better the likelihood of weaning a patient successfully Patients with a NIF exceeding 30 cmH20 can be weaned successfully with a high probability while extubation for those with a NIF of only 20 cmH20 or less will most likely prove unsuccessful EvitaxL determines value of NIF during a manually extended expiration Touch Special Procedure screen function key EvitaxL displays the Additional Function menu Touch Diagnostics screen key Touch NIF screen key EvitaXL displays the last measured value of NIF in larger characters with time date in the left hand column The value of the previous measurement is shown in the right hand column To measure the NIF value Touch and hold the screen key Exp hold for the desired expiratory time Expiration is terminated by the ventilator after max 15 seconds EvitaxL will end the measuring maneuver automatically after a maximum of 15 seconds To view additional text information Touch screen key To quit the menu Touch x screen key References 17 18 page 221 25 50 60 emH20 Limin Freeze a gt Flow Special Procedure Additional Diag Function nostics NIF Exp Hold NIF Time Date touch and hold 0 cmko NIF 1127 Tim
54. failure with fully operational batteries Fully charged integrated battery Two fully charged external 12 V lead acid gel type batteries order no 18 43 303 with a capacity of 17 Ah each External batteries Type Minimum capacity 12 V battery 24 V battery Max charging current through the DC power pack the battery used must be rated for at least this charging current 12 V battery 24 V battery Charging time for 18 43 303 two batteries connected in series 24 V lead acid gel type battery Integrated batteries Type Charging time Protection class see Charge indication and battery charge on page 56 see AC DC Powered Operation on page 54 see Charging Times on page 56 kkk Technical Data DC Power Pack DC DC Converter 10 to 30 V DC Typically 13 A max 30 A Typically 6 A max 15 A Typically 14 minutes at least 10 minutes Typically 2 hours Lead acid gel type batteries sealed maintenance free 30 Ah take note of the charging current requirements 15 Ah take note of the charging current requirements Approx 5 5 A Approx 3 A Typically 8 to 10 hours Lead gel batteries sealed maintenance free Typically 1 5 to 2 5 hours 191 Technical Data Data Protocols Data Protocols LUST protocol LUST List controlled universal interface driver program compatible with the RS 232 interface in Evita ventilators from software version 7 n upwards The LUST p
55. for use in health care facilities only and exclusively by persons with specific training and experience in its use WARNING The EvitaXL ventilator must only be used under the super vision of qualified medical personnel in order to provide immediate corrective action in case of a malfunction WARNING Whenever a patient is connected to the ventilator constant attention by qualified medical staff is required in order to provide immediate corrective action in case of a malfunction WARNING This device is to be used only in rooms with line power installations complying with national safety standards for hospital patient rooms e g IEC 601 1 Safety of Medical Equipment To maintain grounding integrity connect only to a hospital grade receptacle Always disconnect supply before servicing WARNING DANGER risk of explosion if used in the presence of flammable gases or anesthetics This device is neither approved nor certified for use in areas where combustible or explosive gas mixtures are likely 22 WARNING Do not use mobile phones within 33 feet 10 m of the ventilator Mobile phones can cause interference with electrical and electronic medical equipment with the risk of patient injury WARNING Do not use in conjunction with magnetic resonance imaging MRI Equipment malfunction with the risk of patient injury may result WARNING Using high frequency electrosurgery equipment defibri
56. is dry and free from dust filtered to 1pm and oil Contaminated gas may cause ventilator malfunction Required supply pressures are between 3 and 6 bar 43 to 87 psi Important Safety Information Summary of WARNINGS and CAUTIONS WARNING Installation of the Evita nurse call kit should only be performed by DraegerService or factory trained and authorized service personnel WARNING The operator of the ventilator must still assume full resposibility for ventilation monitoring via the EvitaXL screen when the nurse call is connected Only highest priority alarms will activate the nurse call Check screen displays frequently WARNING A fault in any of the components in the link between nurse call and central hospital alarm system e g in the electronics for nurse call in EvitaXL in the EvitaXL power supply or in the enunciator of the central hospital alarm system may result in failure of the nurse call WARNING Installation of the Evita 4 Link interface card may be performed by factory trained and authorized service personnel only CAUTION Do not drop control panel physical damage to the unit is likely Do not allow control panel to lean against any objects in an upright position When changing panel lay it on its back CAUTION To prevent accidental blockage of air intake protective cover must always be in place for operation CAUTION Analog Interface Do not supply any e
57. minutes using a cleaning and disinfecting machine Use detergent only Or Bath disinfect using a disinfectant based on the suggested active substances e g Cidex Johnson amp Johnson Or Autoclave at 134 C 273 F Components of reusable patient circuit and expiratory valve or in the event of severe soiling its disassembled components Disinfect in a moisture saturated environment at 93 C 200 F for 10 minutes using a cleaning and disinfecting machine Use detergent only If a cleaning and disinfection machine is not available Bath disinfect components using a disinfectant based on the suggested active substances Then rinse with clean water preferably from a soft water supply Shake water out thoroughly and leave the products to dry Care Disinfecting Cleaning Sterilizing 151 Care Disinfecting Cleaning Sterilizing Expiration valve and its individual parts after disinfection Rinse thoroughly with clear water preferably from a soft water supply Shake water out thoroughly After rinsing thoroughly dry expiratory valve After disinfecting with moist heat we recommend that the expiratory valve or its disassembled components be autoclaved at 134 C 273 F to remove any remaining liquid CAUTION Make certain that no liquid remains in the pressure measuring canal of the expiratory valve as it might cause malfunction Ventilation hoses wat
58. mode An additional screen knob Tinsp is displayed for CPAP PSupp EvitaxL limits the maximum duration of a pressure supported breath to 4 seconds in Adult patient mode and to 1 5 seconds in patient mode Ped The maximum duration of a pressure supported ventiator breath can be limited with the Tinsp screen knob Tinsp also limits the duration of pressure supported breaths in the other ventilation modes which can be combined with Pressure Support 94 Evita XL Standby non invasive ventilation may not be used on intubated patients Check alarm limits after change from mask ventilation NIV to tube mode Start Standby x New Current Patient Patient Application Tube Start Standby Tube Attention Mask The mask ventilation mode NIV for E ifier Check Standby 6 Mask Ventilation Pmean PEEP 125 100 Values O Main Vol 96 FiO Data Special L min MV Procedure Sos 15 Y 20 Limin MVspn bpm frotar L Vii O uq igi 2 S Ext 3i Int emH20 Freeze Apnea vent On VTapnea A480 f pnea 42 40 a Ph 20 p e ae 10 50 Limin Flow E Ph 25 0 25 50 Ventilator Settings 2 5 X SIMV CMV PCV I I Basic settings O2 Tinsp Slope 46 Mask Ventilation Press Yol Limin Limin bpm PEEP ios Fio 35 MV 4 5 ids MVspn 4 5 flota
59. parts Breathing gas humidifier Disassemble according to its respective Operating Instructions and prepare for disinfection sterilization Care Dismantling Components ice gt O q 2 0 A y 149 05437547 05537376 05637376 Care Disinfecting Cleaning Sterilizing Disinfecting Cleaning Sterilizing CAUTION Certain components of the ventilator consist of materials that are sensitive to certain organic solvents sometimes used for cleaning and disinfecting e g alkylamines phenols halogen releasing compounds oxygen releasing compounds strong organic acids etc Exposure to such substances may cause damage that is not always immediately recognized To prevent any damage we recommend that only detergents and disinfectants are used that are compatible with the device e g surface disinfectants on the basis of aldehydes or quarternary ammonium compounds for disinfection Ensure that all disinfectants are registered with the U S Environmental Protection Agency for use as intended Always follow the instruction labels specifically with respect to prescribed concentrations and the necessary exposure times Disinfectants often contain besides their main active agents additives that can also da
60. process nebulizer in accordance with its accompanying Instructions for Use The individual parts of the nebulizer and the adapter parts may be processed in an automatic parts washer and disinfection machine see page 152 Dismantling Components Care 7 147 05037547 05137547 05237547 Care Dismantling Components Patient circuit Remove patient circuit from adapters and ventilator ports For a Draeger reusable patient circuit Remove water traps from patient circuit Remove collecting jars from water traps and the expiratory valve Prepare patient circuit water traps and associated collecting jars as well as the the patient wye for processing in an automatic parts washer and disinfection machine see page 151 CAUTION When removing a reusable patient circuit always grasp hoses by their sleeve never by the hose itself to avoid possibly tearing the hose at the sleeve or ripping it out of the sleeve Flow sensor e Tilt the control panel upwards pressing the segments on the right and left down and at the same time tilting the control unit into the required position Push flow sensor as far as possible to the left and 2 remove it CAUTION Flow sensor is not compatible with parts washer equipment and may not be autoclaved or steam sterilized It is not temperatur
61. removing diaphragm pa Sn L Xera suononasu 8unejedo Operating Instructions EvitaXL 1 US ed CAUTION Certain components of the ventilator consist of materials that are sensitive to certain organic solvents sometimes used for cleaning and disinfecting e g alkylamines phenols halogen releasing compounds oxygen releasing compounds strong organic acids etc Exposure to such substances may cause damage that is not always immediately recognized CAUTION The surface of the EvitaXL screen is made of Plexiglas amp polyacrylate Exposure to alcohol or agents containing alcohol will likely cause fissure cracks CAUTION Make certain that no liquid remains in the pressure measuring canal of the expiratory valve as it might cause malfunction Important Safety Information Summary of WARNINGS and CAUTIONS Precautions during maintenance WARNING To avoid any risk of infection clean and disinfect ventila tor and accessories before any maintenance according to established hospital procedures this applies also when returning ventilators or parts for repair WARNING Never operate the ventilator if it has suffered physical damage or does not seem to operate properly We recommend that you contact DraegerService for maintenance service for the EvitaXL Ventilator WARNING Treatment of batteries and O2 sensor capsules Do not throw into fire Risk of explosion Do not force open Danger of bodil
62. row of displayed screen knobs and settings EvitaXL displays the Ventilator Settings menu The selected screen knob is already yellow and may therefore be adjusted immediately Display example Turn dial knob to adjust setting press dial knob to confirm The color of the screen knob changes to dark green the setting is now in effect To call up additional information texts Touch screen key To quit the menu Press X screen key Arrows on the dials of screen knobs indicate the initial values in effect when the ventilator is switched on These defaults can be adjusted to specific hospital requirements see Configuration page 139 Operating Concept Z8 gPev I ALA es APR pes O2 HE 10 25 Texp 43 MY 45 vr o 00 Tinsp f bpm o PEEP Slope Psupp ELS Paw m A O Freeze 40 aA gt 20 F1 EA r1 0 10 go min Flow ggm gr 25 0 25 50 Ventilator Settings zax Basic settings Prnean PEEP 123 1 0 5 HD vaves e Main Yol FiO 35 Data Special L min MV Procedure 5 15 4 Y 20 Lmin MV bpm Flota ou E 65 Ext 3l Int On Screen Controls SIMV AutoFlow 31 09837547 32 This page intentionally left blank pa Sn Lb Xera suononasu 8unejedo Operating Instructions EvitaXL 1 US ed Preparation Positioning The Control Panel oococoocccccccc ne 34 Assembly of Components
63. the breathing effort and breathing muscles are trained References 6 7 8 9 page 221 Theory of Operation Ventilation Modes Paw Phigh Plow gt i Thigh Tlow Paw Prescribed ideal airway pressure PASB I ei Start of inspiration End of inspiration Insp Flow A max 4 s 25 Insp Flow for adults 25 Insp Flow for paediatrics t 205 18637547 02137547 Theory of Operation Ventilation Modes With the patient adjusted pressure rise activity defines the required inspiration flow which can rise to 2 L s in just 8 ms Pressure support is terminated when inspiratory flow returns to zero during phase l i e when the patient exhales or fights the ventilator or when inspiratory flow in phase II falls below a certain ratio of the maximum value previously supplied when compared to the peak inspiratory flow supplied for adult ventilation 25 of inspiratory flow for pediatric ventilation 25 96 of inspiratory flow or atthe latest after 4 seconds 1 5 seconds during pediatric ventilation if the two other criteria have not triggered termination of the breath If this 4 second criterium is activated three times in succession EvitaxL will generate an alarm and will alert to the possibility of a leak in the patient circuit 206 pa Sn Lb Xera suononasu 8unejedo
64. the respective screen key o e Main to select the main screen 123 Values to select a different group of measured values in the field for numerical values Data to display all measured values the logbook or trends on an additional screen card Special Procedure to select additional functions e g nebulization of pharmaceutical aerosols and oxygenation for bronchial suction Other on screen function keys can be configured individually see Configuration page 134 27 09637547 Operating Concept Fixed Function Keys On screen Controls Fixed Function Keys provide immediate access to major on screen functions such as selection of the ventilation mode setting of ventilation parameters or adjusting of alarm limits 1 Alarm Silence for silencing the audible alarm for two minutes Alarm Limits for adjusting alarm limits V Ventilator Settings for setting ventilation mode and ventilation parameters Unassigned key for future functions S Sensor Parameter for calibrating sensors and for activating deactivating monitoring functions 1 System Setup for configuring system functions Start Standby for selecting standby mode or normal operation On Screen Controls 8 28 In aseparate field at the bottom of the main screen EvitaXLdisplays the ventilation parameters required for the active
65. ventilation mode in the form of virtual screen knobs for the respective settings n AO Or OOARWN m 700 500 300 100 Freeze ge ta S l MV LET AutoFlow a Pmean PEEP 12 3 100 Values 1055 e Main Yol FiO Data 35 Special Limin my Procedure 4 5 A Umin MVepn bpm frota L Vri ADO lar 6 Ext ES Int 03037376 09637547 pa Sn L 1Xe3 suononasu 8unejedo Operating Instructions EvitaXL 1 US ed To set the ventilation mode and ventilation parameters 1 Press HE Ventilator Settings or touchone ofthe virtual screen knobs at the bottom of the screen EvitaXL displays the menu Ventilator Settings in the bottom part of the screen example Screen knobs and screen keys are displayed in the form of horizontal and vertical tabs as on a file catalog card Horizontal screen keys for selecting the ventilation mode Vertical screen keys for selecting supplemental settings Operating Concept On Screen Controls Dr ger EvitaxL JUL e gp mH20 Paw AAA AA AAA A A Freeze 40 Lt 20 E a m 0 10 F 50 Limin low aA gt 0 25 y 50 Ventilator Settings ales EE coo a Ca 66 Basic y settings Add 02 vr Tinsp f Slope eines Apne
66. 34 C 10 minutes EvitaXL ventilator after each patient no outside no no Mobile stand after each patient no outside no no circuit support arm gas supply hoses Patient circuit after each patient yes no possible yes patient wye weekly water traps and collecting jars Expiratory valve after each patient yes no possible yes weekly Flow sensor after each patient no outside possible no weekly Temperature sensor after each patient no yes no yes weekly CO sensor optional daily no yes no no Cuvette of the CO2 daily yes no yes yes sensor optional Test filter for CO2 daily no yes no no sensor optional SpO2 sensor after each patient no yes no no optional weekly Breathing gas after each patient In accordance with separate Instructions for Use humidifier weekly Medicament nebuliser after each patient In accordance with separate Instructions for Use optional weekly Bacterial filter In accordance with separate Instructions for Use with an approved wipe disinfectant based on the recommendedactive ingredients see page 150 Nebulization may lead to formation of more extensive deposits requiring more frequent replacement Special treatment bath disinfect in 70 ethanol see page 148 Wipe disinfect e g with 70 ethanol see page 146 Pon 153 Care Re assembly Re assembly Assembling the expiratory valve The parts must be entirely dry to prevent malfunctioning Hold cover li
67. 5 Limin ftotat 10 bpm Vre 450 L 0 MVspn O Lmin fson 0 bpm VTrsupp E Table 4 Ppear 28 cmH20 dE Table2 Pm fita Ppiat 25 cmH20 Pmean 10 cmH20 R 12 cmH20 Lis 10 PEER 5 cmH20 e 23 mL cmH20 i Vii Settings 5 0 Mode SIMY 02 35 Vol PEEP 5 cmH20 ue e AutoFlow vr 450 L Psupp 6 cmH20 Patient Adult f 10 bpm Slope 0 3 sec ATO state off Tinsp 17 sec z c Tube ID 8 0 mm ni eu ul 1 Jl Int 103 12737547 12837547 Operation Displaying the Logbook Displaying the Logbook EvitaXL records setting changes events and alarms and lists them in chronological order with the date and time of occurrence Changes are displayed with the former and new settings example 5 cmH20 gt 7 cmH20 Events include for instance use of a nebulizer flow calibration etc Alarms are recorded in the form displayed by EvitaxL at the time of occurrence Other alarms which are triggered with the displayed alarm but are not themselves displayed in the field for alarm messages are identified by an asterisk preceding their entry in the logbook To display the logbook Touch Data screen key the Data menu is displayed e Touch Logbook screen key EvitaXL displays the logbook When a time is highlighted in the trend display page 105 the line corres ponding to that time is highlighted in yellow in the logbook With every recorded change in settings EvitaxL displays the complete list of new settings for the venti
68. Contacta licensed waste disposal company for appropriate disposal of EvitaXL Follow all local state and federal regulations with respect to environmental protection when disposing of the ventilator NOTE Because the battery installed in EvitaXL is considered hazardous waste the internal DC battery must be removed by DraegerService or factory trained and authorized technical service personnel before the ventilator may be disposed of Maintenance Correct Disposal of Batteries and O2 Sensors Correct Disposal of the Ventilator 161 162 This page intentionally left blank pa Sn Lb Xera suononasu 8unejedo 164 Troubleshooting 5 ebbe too E AA RO p A He Agr SS PRSE qd pa SN L Xer suononuisu Bunesado 163 Troubleshooting Troubleshooting Alarm messages in the alarm display field are displayed in hierarchical order For example if two faults are detected simultaneously the more urgent of the two is displayed The priority level of the alarm messages see page 97 for definitions is identified by exclamation marks Warning Message with top priority Caution I Message with medium priority Advisory Message with low priority In the table below messages are listed in alphabetical order This table is intended to help identifying possible causes of an alarm and to assist with prompt corrective action The various causes and remedies should be worked through in the order listed unti
69. D connector Connector housing socket Up to 15 m 3000 to 7000 ohm between 3 and 15 V between 3 and 15 V 189 Technical Data Ventilator Outputs Electrical isolation Digital output for independent lung ventilation ILV Analog interface Voltage level Impedance of analog channels Accuracy Electrical isolation Pin assignment 190 Serial port COM1 as well as COM2 and COMG optional are electrically isolated from the ventilator electronics The test voltage for electrical isolation is 1500 V CAUTION Ports COM2 and COMS are not electrically isolated from one another 0 to 4 095 V Output impedance is 200 Q The input impedance of connected equipment should be not less than 1 MQ otherwise the output signal will become distorted 0V 0Vto 0 005 V 4 095 V 4 075 V to 4115 V The socket is electrically isolated from the ventilator electronics The test voltage for electrical isolation equals 1500 V CAUTION Ports COM2 and COM3 are not electrically isolated from one another EvitaXL m GND 1 ERN Pin 1 i Channel 1 2 EE Channel 2 3 Pin2 i Pin 3 Medical appliance connector Connector housing pa SN L 1Xxeu 3 suononaisu Bureaed o Operating Instructions EvitaXL 1 US ed DC Power Pack DC DC Converter Electrical ratings for the DC input socket DC input voltage Input current 12 V battery 24 V battery Power characteristics Time bridged following an AC power
70. E Keys Service total Fio2 R USO Data vr R c Lock SIMV AutoFlow Pros M Values 10 1 0x5 e Main Yol FiO Data 35 Special MV Procedure 4 5 s L min L min MV spr bpm frota m Vri ADO T S Ext 3i Int 10 Freeze ta Qe System Setup System Ventilation Configure groups of measured values displayed on main page HO croup 1 DIO Group 2 DON Group 3 Select 4 Option ES Pmean PEEP vr PEEP Ppeak FiO2 MVspn MY Pplat as MY PEEP MYspn Pmin VTi MV spn Pmean Pmean Vre MY Ttotal FiO2 R MY spn di FiO2 etcO2 vr R c Vas Vads VTe CO2 Overview Graphics Values Trends Function Keys Custom Data Lock Overview Sound Day Night Screen p Country Interface Service SIMV AutoFlow D 10 Values TORES e Main Yol FiO Data 35 Special MV Procedure 4 5 vis Limin Limin MV spr bpm fiot L Vri ADO ui 2 65 Ext cell Int Lg 15137547 18137547 pa SN Lb TXE suononujsu Bueaedo Operating Instructions EvitaXL 1 US ed Defining trends to be recorded Press Hi System Setup key Touch Screen screen key Touch Trends screen key EvitaXL now displays the menu for selecting measured values for the trend display Up to eight measured values can be selected depending on the options available Only the measured values
71. EvitaXL compensates calculated leaks of up to 200 of the settidal volume but not more than 2 L maximum regardless of patient mode Tube compensation ATC The special function Tube compensation regulates airway pressure at the tracheal level This function calculates and displays tracheal pressure on the basis of a mathematical tube model the set tube type and the inside diameter of the tube The selected tube type and the inside diameter of the tube must correspond with the real tube for correct calculation of tracheal pressure EvitaXL calculates tracheal pressure on the basis of a square function of tube resistance and patient flow PTrachea PAW KTube x Flow PTrachea Pressure in the trachea PAW Pressure at the Y piece of the hose system KTube Tube coefficient see table Flow Patient flow inspiration flow gt 0 exspiration flow lt 0 When automatic tube compensation is active EvitaXL controls ventilation pressure during spontaneous breathing and during pressure controlled mechanical breathing cycles in such a way that the breathing effort required by the resistance of the tube is compensated in accordance with the selected degree of compensation Theory of Operation Measurements 209 Theory of Operation Measurements Compensation may be independently deactivated for the expiratory breathing cycle Depending on the direction of the patient flow the airway pressure is increased during inspiratio
72. No 09937547 SIMV AutoFlow EvitaXL Start Start Standby New Previous Patient Patient Ventilation Sete Standby Ventilation begins with the pre configured start up settings SIMY AutoFlow vr 450 L ATC Off Tinsp 1 7 3e Application tube i 10 bpm Ideal Body Weight Weight PEEP 5 cmH20 02 36 Vol Psupp 6 cmH20 Start Standby w ES eS ext S 47 Preparation Checks of Readiness for Operation 48 Touch Check screen key Touch Device Check screen key EvitaXL displays the date of the last device check performed and a list of the individual checks The scope of this list depends on the options available on the ventilator Standby Pmean PEEP 123 E S 100 Values y e Main Yol FiO Data Special Start Standby X umn my Procedure New Current Patient Patient toni 15 s 20 Start Limin MV pn Overview standby Tube cC Last device check 31 08 2001 09 07 y successful po NM Humid bpm fita Last airtight check 31 08 2001 09 10 Leakage 20 mL min Eu ifier Check ao iy Vr 15 Ze igi 2 O E3 Ext E PB Int Pmean PEEP 123 E s 100 Values y e Main Vol FiO Data e Special Start Standby X umn mv BECAS New Current Patient Patient aos 45 Y 20 mem Start Limin MV spn Device eci um mew Standby System Sensors Tube ao Y Exha
73. O2 monitoring and deactivate integrated O2 monitoring Call DraegerService O2 monitoring off O2 monitoring switched off Switch O2 monitoring on again see page 126 or immediately ensure an adequate alternative monitor function O2 supply down n O2 supply pressure too low Make sure pressure is greater than 3 bar 43 5 psi O2 supply down O2 supply pressure too low O2 supply pressure is not required when FiO2 21 Vol Make sure pressure is greater than 3 bar 43 5 psi O2 supply pressure high O2 supply pressure too high Ensure pressure is below 6 bar 87 psi O2 supply pressure high O2 supply pressure too high O2 supply pressure is not required when FiO2 21 Vol Ensure pressure is below 6 bar 87 psi PEEP high Expiratory system obstructed Check patient circuit and expiratory valve Expiratory resistance is increasing Check bacteria filter Replace if necessary Ventilator faulty Disconnect patient from the ventilator and continue ventilation immediately with another independent ventilator Use PEEP and or elevated O2 concentration as necessary Call DraegerService PEEP valve inop Internal PEEP valve faulty Disconnect patient from the ventilator and continue ventilation immediately with another independent ventilator Use PEEP and or elevated O2 concentration as necessary Call DraegerService Pressure limited Pm
74. Operating Instructions EvitaXL 1 US ed EvitaXL Intensive Care Ventilator Operating Instructions These Operating Instructions apply also to Evita 4 with the XL option SIMV JA Drager MEDICAL Dr ger NOTICE Proprietary Information This document contains information in which Draeger Medical Inc claimed proprietary rights The information may not be reproduced in whole or in part except as authorized in writing by Draeger This information is the property of Draeger Medical Inc it is provided solely for the use intended Repairs Modifications Repairs on this device shall be performed only by DraegerService or factory authorized technical service personnel Information about repairs can be obtained from Draeger or Authorized Dealers Draeger Medical Inc will not be responsible for injury to persons or damage to property arising directly or indirectly out of unauthorized repairs or modifications to this device Furthermore any unauthorized repairs or modifications void any warranty extended by Draeger This document is provided for your information only It will not be exchanged or updated without request Trademarks The Dr ger name and logo are registered trademarks of Draeger AutoFlowQ is a registered trademark of Draeger The registered trademark BIPAP is used under license O Dr ger Medical AG amp Co KGaA 2002 All rights reserved Subject to modifications Operating Instructions E
75. Operating Instructions EvitaXL 1 US ed Measurements Flow measurement Independent of whether ventilation is pressure or volume controlled positive pressures are generated both in the patient circuit as well as in the patient s lung The volume delivered by the ventilator is distributed to both the patient lung and the circuit used between patient and ventilator The distribution occurs according to the ratio of lung compliance versus patient circuit compliance Resulting expiratory deviations for the measured value of flow and the calculated values of minute ventilation and tidal volume are minimal when ventilating adults This is due to the relatively large lung compliance compared to the compliance of the patient circuit Since only the volume actually entering and leaving the lungs is relevant for the efficiency of ventilation and since larger deviations would be possible during pediatric ventilation EvitaxL always compensates for the influence of patient circuit compliance Compensating for the effect of patient circuit compliance During the ventilator check before the start of ventilation EvitaXL determines the compliance of the patient circuit lt then compensates the effect of this compliance on flow and volume measurement during ventilation Dependent on airway pressure EvitaXL increases ventilatory volume in the same amount that will be remaining in the ventilation circuit Besides the influence of patient circuit com
76. P beside the scales on the screen knobs in the Ventilator Settings menu indicate initial default values These start up values may be configured as required see Configuration page 141 66 Freeze PCY I mane APRY pos CH O2 Apnea vent On VTapnea A480 f pnea 12 0 VT Tinsp e PEEP Slope Psupp 40 m lez 50 Limin Flow PN gt 0 50 Ventilator Settings 4 X Basic settings 10 5 Yol FiO 35 Limin MV 4 5 A AE Umin MV spn 0 bpm fitu 10 L Vii Special Procedure 63 Ext Int 09737547 pa Sn L Xera suononasu 8unejedo Operating Instructions EvitaXL 1 US ed Setting Ventilation Modes The following ventilation modes are factory configured at delivery SIMV CMV PCV BIPAP CPAP Pressure Support Other ventilation modes can be selected via the more screen key MMV PCV Assist APRV The ventilation modes can also be supplemented see Setting Ventilation Mode Extensions on page 83 CMV Continuous Mandatory Ventilation Volume controlled ventilation with fixed mandatory minute volume MV set with tidal volume VT and ventilator rate frequency f Set the pattern of ventilation for CMV with the ventilation parameters Tidal volume VT Inspiratory Flow Flow Ventilator rate f Inspiratory time Tinsp O2 concentration O2
77. PAW f alarm limit Typically the selected inspiratory time Tinsp is much longer than the lung filling time The inspiration pressure Pinsp corresponds to the minimum value calculated from the tidal volume VT and compliance C of the lung The inspiratory flow is automatically controlled so that there is no pressure peak caused by the resistances of the tube and the airways The plateau pressure Pplat varies with changes in compliance C as is normal in all volume controlled ventilator breaths With AutoFlow these fluctuations occur in increments with a maximum of 3 cmH20 between ventilator breaths If tidal volume VT is reached inspiratory flow 0 before inspiratory time Tinsp has fully elapsed the control system for the inspiratory and expiratory valves ensures that the patient can breathe in and out during the remaining inspiratory time even during the constant pressure plateau Pplat If the patient breathes in or out during mandatory inspiration the plateau pressure Pplat is not changed for the duration of this ventilator breath only inspiratory and expiratory flow are adapted to the patient s demand The applied tidal volume VT may differ from the set tidal volume VT in individual ventilator breaths but as an average over time a constant tidal volume VT is supplied Overshoot in tidal volume VT can be limited by the alarm limit VTi f If the set alarm limit is exceeded once EvitaXL generates an advisory message if
78. Procedure MV spn 0 10 Vri 50 63 Ext Int 141 16337547 Configuration Specific Initial Therapy Values Setting start up defaults for O2 I E pressure O Press E System Setup key Touch Ventilation screen key Touch Mode amp Settings screen key and enter access code 3032 Touch O2 EE pressure screen key EvitaxL displays the default values used for pressure O2 and I E In the respective lines Touch the corresponding screen key Adjust and confirm with the dial knob In addition to the ventilation parameters VT and f EvitaxL also displays a table with the parameters inspiratory time Ti derived from the ratio of inspiratory to expiratory time E and Flow To restore the manufacturer s default settings Touch Dr ger Default screen key Press dial knob to confirm Setting start up defaults for special functions To define the following start up settings AutoFlow on off Apnea ventilation on off Leakage compensation on off Tube compensation on off Tube compensation parameters O Press E System Setup key Touch Ventilation screen key Touch Mode amp Settings screen key and enter access code 3032 Touch Add settings screen key Touch the respective screen key to activate or deactivate a corresponding special function Press dial knob to conf
79. S SUPPLY CAN CAUSE EQUIPMENT MALFUNCTION FEDERAL USA LAW RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A PHYSICIAN CAUTION DO NOT BLOCK 1 AIR INTAKE 177 178 This page intentionally left blank pa Sn Lb Xera suononasu 8unejedo Operating Instructions EvitaXL 1 US ed Environmental Conditions sssee Hn 180 Settings i cere Ete deep ted qot ene Cad dati cect ca a eara aye Vs uod Doc de 180 ATC Automatic Tube Compensation 0 0 00 cece eee eee 181 Performance Data ix cide Pid i be ie Pip Aci E Ae ae eh ee ed 181 Monitoring idR a a stad depo deb a ays dao A esed 185 Operating Data tucanes ata oe tdt he d erdt tre det 186 Materials Used o eee Turre Et pdt eee edes 188 Nurse Call Available Option sseesssssee I 188 Ventilator Outputs iiis pedii arp e pet perpe a DR RR ER eR a 189 DC Power Pack DC DC Converter 191 Data Protocols ede e t aub ace ed e pan ean Ense eM Ea A 192 179 Technical Data Environmental Conditions Settings Technical Data Environmental Conditions In operation Temperature Atmospheric pressure Rel humidity In storage Temperature Atmospheric pressure Rel humidity Settings Ventilation frequency f Inspiration time Tinsp Tidal volume VT Pediatric range Accuracy Adult range Accuracy Inspiratory Flow Pediatric range Adult range Inspiratory pressure Pinsp Inspiratory pressure limit Pmax O2 concen
80. This device must be inspected and serviced at regular intervals A record must be kept on this preventive maintenance We recommend obtaining a service contract with DraegerService through your vendor For repairs we recommend that you contact DraegerService WARNING To avoid any risk of infection clean and disinfect ventila tor and accessories before any maintenance according to established hospital procedures this applies also when returning ventilators or parts for repair WARNING Never operate the ventilator if it has suffered physical damage or does not seem to operate properly We recommend that you contact DraegerService for maintenance service for the EvitaXL Ventilator WARNING When servicing the ventilator always use replacement parts that are qualified to Draeger standards Draeger cannot warrant or endorse the safe performance of third party replacement parts for use with the EvitaXL ventilator 158 pa Sn Lb Xera suononasu 8unejedo Operating Instructions EvitaXL 1 US ed Maintenance Maintenance Intervals Maintenance Intervals O2 sensors Air intake filter Cooling air filter Filters in the compressed gas inlets Battery of the DC integrated power pack External battery optional Clock module Pressure reducer Equipment inspection and service Replace when the following message is displayed O2 measurement inop or when calibration is no longer poss
81. Vas 176 Labels di tea tota n data dle Dae ches betes 177 173 Control Panel What s What Control Panel A Alarm Silence key for silencing audible alarms for 2 minutes y Alarm Limits key for setting alarm limits HE Ventilator Settings for setting ventilation modes and parameters Unassigned key for future functions S Sensor Parameter key for calibrating sensors and for activating deactivating monitoring 81 System Setup for configuring ventilator functions O Start Standby for switching between operation and standby mode Central rotary dial knob for selecting and confirming settings Touch sensitive screen for displaying application specific Screen views 174 EvitaXL de sw tif pa Sn L Xera suononasu Burejed o Operating Instructions EvitaXL 1 US ed Front Connections Front Connections Dr ger e i e E N C 1 Flow sensor 2 Expiratory valve with expiratory connector port 3 Latch for expiratory valve 4 Nebulizer connection 5 Inspiratory connector port 6 Locking screw for protective cover behind it O2 sensor and ambient air intake filter 175 18037376 Back Panel Back Panel 13 12 11 8 9 Power switch with protective flap COM2 COM3 sockets for RS 232 two CAN inte
82. Vii SIMY AutoFlow vr 450 L PEEP 5 cmH20 imi F 15 ATC off Tinsp 17 sec O2 36 Vol Application tube f 10 bpm Psupp 6 cmH20 ig 2 63 Ext lll Int Drager EvitaXL 03137547 03237376 pa SN L Xera suononasu 8unejedo Operating Instructions EvitaXL 1 US ed Displaying Graphics The following real time waveforms can be displayed PAw t Flow t Volume t etCO t optional or areal time waveform combined with a short trend Touch Main screen key To select a different real time waveforms Touch the respective screen key A f gp and EvitaxL displays the Curves menu Touch the screen key Curve only Touch screen key for the desired real time waveform parameter EvitaxL displays the real time waveform for this parameter The menu disappears automatically To freeze real time waveforms see Freeze on page 100 To display a real time waveform in combination with a short trend In the menu Curves Touch Curve Shorttrend screen key The respective real time waveform may be combined with the short trend for any parameter to be selected The selected real time curve is displayed in the menu the screen key of the selected short trend parameter appears in dark green Touch screen key of the desired parameter to be assigned for the short trend EvitaxL displays the associated parameter as a short tr
83. a period of one year from date of delivery The following are exceptions to this warranty 1 The defect shall be a result of workmanship or material Defects caused by misuse mishandling tampering or by modifications not authorized by Draeger Medical Inc or its representatives are not covered 2 Rubber and plastic components and materials are warranted to be free of defects at time of delivery Any product which proves to be defective in workmanship or material will be replaced credited or repaired with Draeger Medical Inc holding the option Draeger Medical Inc is not responsible for deterioration wear or abuse In any case Draeger Medical Inc will not be liable beyond the original selling price Important Safety Information Warranty Application of this warranty is subject to the following conditions 1 Draeger Medical Inc or its authorized representative must be promptly notified in writing upon detection of the defective material or equipment 2 Defective material or equipment must be returned shipping prepaid to Draeger or its authorized representative 3 Examination by Draeger or its authorized representative must confirm that the defect is covered by the terms of this warranty 4 Notification in writing of defective material or equipment must be received by Draeger or its authorized representative no later than two 2 weeks following expiration of this warranty The above is the sol
84. a Te ao Dab eee 185 Monitoring functions switching Off acia dos ad ee a da a e Leal 126 Monitoring ventilation 2 0 eee ees 23 N Nebulization Su cri ipe diadha iia cee I 106 Nebulizer pharmaceutical dismantling ideals em Yara S tsm tme dto trees 147 se xc tr ded dd us dd es d dt 106 NIF negative inspiratory force ooooommmmo 115 description 3 4 sho Soo tae e ia ina 213 Nurse call technical data nica a id ies 188 227 Index O O2 sensor Correct disposal aitor tasar ire 161 Occlusion pressure P 0 1 0 cece 113 descripllon atrasa rias ota qs 212 Operating concept cee es 26 Operating data 222csecceee teer etent ete t leds 186 Operation vaia nein ea aeni ale deed 62 theory of novi Se tae wee ri 198 Ordering information 1 0 ccc cece eee eee 224 Outputs ventilator data lessen 189 P Parts user replaceable ssesssseeees 160 Parts washer 000 c cece eee eens 16 148 Patient mode setting start up default 0 cece 139 Patient safety operator s responsibility for sess 8 Patients non infectioUS 0ocooccoccoocn 153 PCV description olor ce toi a nae oe 203 SOING omitir o sad wet 78 PCV Assist descripto inia ia a ote beeen ee 204 SOMO nats ot Hea Lee ht wae tne cada eie 80 Performance data 0c cece cece 181 Phones mobile 0000 cee eee neces 11 22 PLV description sanaaa mk ege nde nie 198 S
85. a vent On VT Apnea 480 dl Tapnea 12 PEEP Psupp SIMV AutoFlow PEEP 12 10 58 e Main Vol 96 FiO Data Special 35 MV Procedure 4 5 Ven Limin MV spn 0 bpm Flota 10 A50 2 Values L min ES Ext 3i Int 29 00137376 09737547 Operating Concept On Screen Controls The touch sensitive screen controls are used in the same way as real keys and knobs Touching these controls with a fingertip is equivalent to pressing a key or taking hold of a knob Settings are made and confirmed by turning and pressing the central rotary dial knob The status of the screen controls is indicated by their color grey not available yellow ready for use pale green may be adjusted but is not active dark green may be adjusted and is active Screen keys 1 Touch a screen key to select it 2 The screen key turns yellow 3 Press dial knob to confirm 4 The screen key turns pale dark green respectively Screen knobs 1 Touch a screen knob to select it The screen knob turns yellow Turn dial knob to set Press dial knob to confirm a fF WN The screen knob turns pale dark green respectively 30 nananana nava a7a pa SN L Xera suononasu 8unejedo Operating Instructions EvitaXL 1 US ed To set ventilation parameters directly From the main screen example Touch the desired screen knob in the
86. ail 2 Press segments on the right and left and tilt control panel fully downwards 3 Hold down release buttons on the left and right and remove control panel from its mounts on the EvitaXL main unit Uncoil the cable as far as necessary Mount the control panel to the wall rail and 34 Ls ZN 17037376 09137376 09237376 pa SN Lb Xera suononasu 8unejedo Operating Instructions EvitaXL 1 US ed 1 Lockin place by pulling down the latch located beneath the bracket and turning it in the direction of the wall rail NOTE The control panel rail clamps are designed for use with 25 x10 mm wall rails Assembly of Components WARNING Always install components that have been cleaned and disinfected according to approved hospital procedures Installing the expiratory valve 2 Tilt control panel upwards pressing the segments on the right and left at the same time 3 Push patient block fully into mounting receptacle Check that it is properly engaged by gently pulling on the port It should stay securely attached Preparation Assembly of Components as 35 09337376 06837376 Preparation Assembly of Components Mounting a flow sensor 1 2 Push
87. ajor functions 3 Central rotary dial knob for selecting and confirming settings on screen F A Fl 26 00237376 pa Sn Lb Xera suononasu 8unejedo Operating Instructions EvitaXL 1 US ed Operating Concept The Screen The Screen displays all the most important ventilation data at a glance D O The various screen pages use the same O Lecce A layout with specific data being A hii 10 5 iil vaus presented always in the same place 40 1 Alarm messages 20 KA E E voi Fio one 2 Operator prompts o 25 on 10 3 Therapy status with ventilation mode ae ane a NE PURA e g ventilation mode gt g SIMV ventilati d s a supplements e g AutoFlow 4 5 5 patient mode e g Adult for E Umin MV adults e 0 4 Waveforms loops and trends oe visualizing ventilation my Ca es e g the real time waveforms of 500 1 0 Paw t Flow t VT t parameters ES 7 TE displayed can be configured EN 100 450 5 Presentation of set ventilation B i A E B m 2 A VENE p parameters for the active ventilation 6 O mode and its extensions ERE MONA o o ui D e hg 6 Essential measured values of mee i He i ESI Mea il int ventilation can be configured 7 Humidification type and status Touch sensitive screen keys for the specific screen pages can be configured 9 Power supply indicator To select a screen page Touch
88. alues Trends Function Keys Custom Data Lock Overview J Graphics Overview Sound Day Night Screen Country Interface Service SIMV AutoFlow DEED 10 5 vol 35 L min MV 4 5 s Umin MV spn 0 bpm Frotal 10 123 100 Values Data Special Procedure ES Ext Int Paw Freeze m 2e System Setup x System Ventilation hN Deutsch Language US English s English Overview nglish ETT T ound Pressure Temp coa Francais Day Night Espa ol Units emH20 oF mmHg Portugu s Screen Italiano Svenska Day Month Year Nederlands SEU CCK Date 10 10 2002 Bes Interface Service Hour Minute Time 1 16 SIMV AutoFlow PEEP 9 5 Pmean Vol Fio2 36 Limin MV 3 61 sn Y 250 Limin MVspn 0 00 bpm ftotal 59 pit a E 15637547 15737547 pa SN L Xema suononuasu Buiyesodo Operating Instructions EvitaXL 1 US ed Selecting units Specific national units may be selected for the physical parameters pressure and temperature as well as body height O Press E System Setup key Touch FJ Country screen key The current units are displayed in the field Units Touch screen key of the desired unit Select and confirm new unit with the dial knob Setting date and time O Press E System Setup key
89. anical volume controlled ventilation and spontaneous breathing The patient can breathe spontaneously between mandatory ventilator breaths contributing to the total minute volume Spontaneous breaths can be supported with Pressure Support Mandatory ventilator breaths ensure a minimum level of ventilation between patient breaths By setting the two parameters tidal volume VT and ventilator rate f this minimum ventilation is determined as the product of VT x f During the weaning process the ventilator rate may be reduced to zero The ventilator will then automatically change to ventilation modes CPAP or CPAP PS respectively The new ventilation mode is also indicated on screen The SIMV screen key and the screen knobs for setting SIMV parameters remain on display Set the pattern of ventilation for SIMV and SIMV PS with the ventilation parameters Tidal volume VT Insp flow Flow Ventilator rate f Inspiratory time Tinsp O2 concentration O2 Positive end expiratory pressure PEEP Pressure support PSupp Pressure rise time Slope To set Touch the respective screen knob Turn dial knob to adjust setting Press dial knob to confirm setting Please refer to page 201 for a detailed description of SIMV Please refer to page 205 for a detailed description of Pressure Support Operation SIMV SIMV PS Paw Pmax configurable ASB pressure
90. apacity of batteries must be checked regularly and the batteries replaced if necessary Avoid deep discharges they lead to premature wear CAUTION Avoid storing the ventilator for extended periods at temperatures over 50 C The internal battery and O2 sensors may be damaged or equipment life may be shortened pa Sn L Xera suononasu 8unejedo Operating Instructions EvitaXL 1 US ed AC DC Powered Operation Connecting an External Battery Optional Connecting an External Battery Optional Note the requirements for external batteries see page 54 1 Connect external battery using the battery cable from battery kit 84 11 822 Ensure that the battery is ES connected with correct polarity black to redto 2 Plug connector into DC socket on 2 the back of the ventilator B B O CJ A WARNING Do not connect any AC powered equipment to the external battery connection socket of the ventilator The ventilator will automatically detect the voltage of the external battery 12 V or 24 V 57 nacanana AC DC Powered Operation Power source displays Power source displays EvitaxL indicates the type of power supplied in the equipment status field at the bottom right of the screen via symbols and colored LEDs Display exam
91. arameter Set and confirm with dial knob Service To display the operating status of the internal functional components Only available to authorized personnel with the necessary password 138 Freeze ta Qe System Setup x System Ventilation Protocol Baudrate Parity Stopbit Interval Overview COM 1 Medibus 19200 none 1 oie Sound Day Night COM 2 LUST 4800 Screen p Country COM3 Printer 9600 30 Min Interface Service Channel 1 Channel 2 Analog Paw Flow SIMV AutoFlow l0 8 Yol FiO 35 Limin MV 4 5 V an Umin MV spn 0 bpm fita 10 Vri Data Special Procedure 63 Ext Int 15937547 pa SN L TXeHAW suononajsu BuiyesodO Operating Instructions EvitaXL 1 US ed Specific Initial Therapy Values Press 5 System Setup key Touch Ventilation screen key EvitaXL displays the System Setup menu with an overview of those therapy parameters that can be set as initial default values Setting the patient range From the menu System Setup submenu Ventilation Touch Patient Range screen key and enter access code 3032 The numbers must be touched in the correct order EvitaxL displays the menu for setting the patient mode to be in effect when the ventilator is switched on EvitaxL displays the last patient mode set Adults or Pediatrics is used here as default Touch W scree
92. ase of the mobile stand Refer to Ordering Information for details on purchasing these batteries and the required connecting cables For an Evita 4 ventilator upgraded with EvitaXL DC operation is possible even if no DC option was installed previously 54 Commercially available rechargeable lead acid gel type batteries can also be used See Technical Data page 191 for requirements to be met by the external batteries WARNING Only use rechargeable batteries Explosion hazard Single use batteries may explode when being charged with the DC power pack while ventilator is operating on line power DC socket Socket on the back of the DC power pack for connecting an external battery This socket is identified as follows DC power pack FB 12 V 24V DC WARNING Only use rechargeable batteries Explosion hazard Single use batteries may explode when being charged with the DC power pack while ventilator is operating on line power WARNING Only external batteries may be connected to the DC Socket of the ventilator and only using the connecting cable specified in the Ordering Information WARNING Do not connect any AC powered equipment to the external battery connection socket of the ventilator AC power AC line power 7 mains power supply for the ventilator is supplied via the AC power cord For voltage ranges characteristics of AC line power see Operating Data on page 186 pa Sn Lb
93. ate airway resistance and a small bellow to simulate compliance Insert the connector into the Y piece only when EvitaXL advises you to do so Switch ventilator on by pressing power switch on the back panel until it clicks into position 46 09437376 09537376 a 0 0 pa Sn L 1Xe3 suononasu 8unejedo 09037376 Operating Instructions EvitaXL 1 US ed The self test screen with version no date and part no of the software used is then displayed on EvitaXL The self test is performed automatically Wait for this test phase to be completed The bargraph indicates the time elapsed for the self test Afterwards EvitaXL will display an opening screen EvitaXL will start ventilation with the pre configured settings unless values are changed or standby mode is activated within 30 seconds On the opening screen example Touch Standby screen key within 30 seconds and press dial knob to confirm Standby activated appears in the line for alarm messages To reset this message Touch Alarm Reset screen key to the right of the message and press dial knob to confirm Dr ger Preparation Checks of Readiness for Operation EvitaXL Selftest Version Part
94. ated flow corresponds to the air volume trapped in the lungs Vtrap by Intrinsic PEEP Measuring times of the measuring phase 1 for Intrinsic PEEP For adult ventilation max 3 seconds For pediatric ventilation max 1 5 seconds Measuring times of the measuring phase 2 for Vtrap For adult ventilation max 7 seconds For pediatric ventilation max 3 5 seconds Insp O2 Concentration When Nebulizing Pharmaceutical Aerosols The integrated nebulizer function of EvitaXL is designed for nebulizers with a nebulizing flow of 6 L min at 29 psi 2 bar for example nebulizer 84 12 935 white body core Other nebulizers may cause considerable deviations in tidal volume and inspiratory O2 concentration To minimize the deviation from the set O2 concentration EvitaXL uses blended gas to drive the nebulizer In adult patient mode this blended gas is produced by switching between the supply gases medical grade air and oxygen in synchrony with inspiration In pediatric patient mode the nebulizer is driven continuously with air and oxygen alternating The driver gas of the nebulizer therefore roughly corresponds to the set FiO2 The graph shows the possible deviations of the applied O2 concentration as a function of the set FiO2 with a minimal inspiratory flow 15 L min in adult ventilation or at ventilation frequencies above 12 bpm during pediatric ventilation Theory of Operation Insp O2 Concentration When Nebulizing Pharmaceutical Ae
95. ax pressure limit is active Check patient condition Check ventilation pattern Correct setting if necessary 171 Troubleshooting Message Cause Remedy Pressure measurement inop Fluid in expiratory valve Replace expiratory valve see page 149 then clean and dry Pressure measurement malfunction Disconnect patient from the ventilator and continue ventilation immediately with another independent ventilator Use PEEP and or elevated O2 concentration if necessary Call DraegerService Psupp gt 4 S n Not displayed in application mode Mask NIV Only appears in adult patient mode The pressure support cycle has been switched off 3 times due to time limitation Check patient circuit for leaks Psupp gt 1 5 s Only appears in pediatric mode The pressure support cycle has been switched off 3 times due to time limitation Check patient circuit for leaks Standby activated 1 EvitaXL has been switched to standby Confirm standby with Alarm Reset key Temperature high Breathing gas temperature higher than 40 C Switch humidifier off Temperature meas inop LUI Temperature sensor faulty Install new temperature sensor page 41 Temperatur sensor LI Temperature sensor probe has been disconnected during operation Reconnect probe Sensor cable broken Install new temperature sensor Tidal volume high m T
96. ay cause the leakage current to the patient to increase beyond permissible values in the event of grounding failure In this case the risk of electric shock cannot be safely excluded Temporary Interruption of Power Supply e g when hospital backup power supply is activated With a discharged12 24 V DC power supply During a power out EvitaXL will trigger a continuous audible alarm of 2 minutes maximum If EvitaXL has been operating for less than 15 minutes this time might be shorter Operation continues without interruption even if the power is interrupted for longer than 10 milliseconds The capacity of the internal batteries of the DC power supply can bridge a power failure of at least 10 minutes provided the charging time since the last use of the internal batteries was sufficient Gas Supply Screw high pressure air and oxygen hoses to sockets on the back panel of EvitaXL and insert their probes into wall terminals WARNING Always use medical grade oxygen and air that is dry and free from dust filtered to lt 1pm and oil Contaminated gas may cause ventilator malfunction Required supply pressures are between 3 and 6 bar 43 to 87 psi 44 Q 08537376 pa Sn L Xera suononasu 8unejedo Operating Instructions EvitaXL 1 US ed Preparatio
97. cause of the alarm is remedied Set PLV with Pmax Please refer to page 198 for a detailed description of PLV 92 Paw Insp pause Pmax NL configu PEEP rable NY Tinsp Te Flow 1 f LN Insp flow gt t Freeze Pu vol 35 Limin MV 45 Flow 02 o o6 Oo Flow Y 20 Limin MV pn 254 0 Ventilator Settings 2 4 x bpm fita mg V8 o CPAP PS pp APRY iaa 1 0 Basic L Vri settings 450 E Data Special Procedure Ext Int 00537547 19537547 pa Sn L Xera suononsysu 8unejedo Operating Instructions EvitaXL 1 US ed NIV Mask Ventilation Available Option Non Invasive Ventilation Application mode Mask for ventilation with a nasal or facial mask to support non invasive ventilation of patients with spontaneous breathing Choose between mask ventilation and regular ventilation of intubated patients WARNING Installation of the EvitaxL NIV option should only be performed by DraegerService or factory trained and authorized service personnel Using NIV WARNING Precautions when using mask ventilation Never ventilate an intubated patient in Mask NIV mode n MASK NIV mode the alarm system is adapted to mask ventilation Make sure that only patients are ventilated in this mo
98. cclusion pressure P 0 1 characterizes the negative pressure during a short occlusion 0 1 s at the start of spontaneous inspiration It is a direct measure of a patient s neuromuscular breathing drive Patients with healthy lungs and regular breathing generate a pressure drop of 3 to 4 cmH20 P 0 1 Values below 4 cmH20 represent a high breathing drive which can only be maintained for a short time Values exceeding 6 cmH20 for a patient with chronic obstructive pulmonary disease indicate impending exhaustion This measuring maneuver can be used in all ventilation modes in order to check the breathing drive of a spontaneously breathing patient or to assess the amount of spontaneous breathing during controlled ventilation Touch Special Procedure screen function key EvitaxL displays the Additional Function menu Touch Diagnostics screen key the special procedure P 0 1 is displayed automatically EvitaxL displays the values for P 0 1 from previous measurements and in large characters the value of the last measurement Touch Start screen key the key turns yellow Press dial knob to confirm the screen key turns green and EvitaXL will start the P 0 1 pressure measuring procedure To view additional text information Touch screen key To quit the menu Touch x screen key It is advisable to record the measured P 0 1 value as a trend so that progres
99. connector socket all the way to the left Gently push flow sensor into its mount with the connector facing towards the ventilator and into the socket as far as it will go Then Push flow sensor to the right and into the rubber lip seal of the expiratory valve as far as it will go Installing an O2 sensor capsule oun o 7 when using the system for the first time when the display reads O2 measurement inop when calibration can no longer be performed Ensure ventilator is placed in standby or is switched off completely Tilt control panel upwards Turn port downwards or to the left Use coin to loosen screw and remove protective cover Loosen the two knurled screws and remove lid from the sensor chamber Insert new sensor capsule NOTE The sensor end with the circular contacts must be 6 5 36 visible Close the sensor chamber securely with the two knurled screws Screw protective cover back in place C 06937547 07037547 07137376 pa Sn L 1Xe3 suononasu 8unejedo Operating Instructions EvitaXL 1 US ed CAUTION To prevent accidental blockage of air intake protective cover must always be in place for operation Dispose of the used O2 sensor ca
100. d by its flange and place diaphragm on the collar of the lid Be careful to fit the diaphragm properly Insert lid with diaphragm on top into the housing from below and screw in tightly If the expiratory valve has an optional water trap Install collecting jar Aerosol nebulizer Assemble in accordance with its separate Instructions for Use see page 107 Breathing gas humidifier Assemble in accordance with its separate Instructions for Use For installation see page 40 and page 43 154 05837376 05937376 06037376 pa Sn Lb Xera suononasu 8unejedo Operating Instructions EvitaXL 1 US ed Before Reusing on a Patient Assemble ventilator as described under Preparation on page 35 Perform checks of readiness for operation see page 46 Care Before Reusing on a Patient 155 156 This page intentionally left blank pa Sn Lb Xera suononasu 8unejedo Operating Instructions EvitaXL 1 US ed Maintenance Intervals 00 ccc eet hn 159 User Replaceable Parts 2 0 0 0 ccc ccc eee cee 160 Correct Disposal of Batteries and O2 Sensors 0 0c eee 161 Correct Disposal of the Ventilator 00 0 cece eee eee eee 161 157 Maintenance Maintenance CAUTION Maintenance
101. d by the identification telegram are transmitted in the data telegram Invalid measured values contain dashes instead of numerical values In addition the data telegram also contains all the messages in the status telegram which have changed since the last status or data telegram The telegram has the following structure Telegram header SOH Start character 050 Identification number 0 Channel number Technical Data Data Protocols Telegram body The body of the telegram contains all the measured values defined in the identification telegram and any number of status messages The number of digits for the measured values is defined in the identification telegram and does not exceed five Commas are also transmitted leading zeroes are replaced by blanks ESC signal number measured value GS number of the status message message text GS number of the status message message text Alarm telegram Alarm telegrams cannot be requested They are transmitted automatically as soon as the alarm status changes Automatic transmission of alarms can however be activated and deactivated see telegram control on Seite 192 The individual messages are sent when an alarm occurs when the alarm status is cancelled The alarm telegram has the following structure Telegram header BEL Start character 050 Identification number 0 Channel number Telegram body ESC alarm warning advisory status alarm
102. d in the logbook on the Data screen via the logbook function see page 104 Power failure alarm If the loudspeaker for generating audible alarms fails due to a fault a continuous tone will be generated by an auxiliary enunciator The same continuous tone also draws attention to a power failure see Temporary Interruption of Power Supply on page 44 Cancel alarm tone for max 2 minutes 1 Press the A key with the lit yellow indicator LED The audible alarm will be cancelled for 2 minutes If the fault that triggered the alarm is still not remedied at that time the audible alarm starts again If you wish to reactivate the audible alarm temporarily 1 Press key with the yellow LED now switched off again Acknowledge Press Alarm Reset to acknowledge the alarms that can be suppressed with Alarm Reset please refer to Troubleshooting on page 164 98 Standby activated Confirm Standby Touch Alarm Reset and confirm Adult 123 E a Wi vaves y e Main Vol 96 FiO Data sos Special Start Standby X Umin my Procedure New Current Patient Patient n 45 Y 20 Ventilation begins with the current settings Start Umin MV spn Standby 7A EER ENS Ideal Body Weight Ventilation a a Tube Mask Humid bpm fiti E dcs B ifier Patient R Adult Ped Weight Check gt L
103. d may impair ventilation Do not put a microbial filter on the nebulizer outlet when in use WARNING Do not use a heat moisture exchanger simultaneously with a nebulizer or heated humidifier Risk of increased breathing resistance due to condensation 15 Important Safety Information Summary of WARNINGS and CAUTIONS WARNING The hot wire in the flow sensors is heated well above its normal operating temperature during the cleaning process Therefore avoid flammable gases e g ethanol vapors after disinfection Vent flow sensors after disinfection with ethanol for at least 30 minutes WARNING In case of malfunction of any of the built in monitoring a substitute has to be provided in order to maintain an ade quate level of monitoring The operator of the ventilator must still assume full responsibility for proper ventilation and patient safety when sensors and their respective alarm functions are deactivated WARNING All data transmitted via Evita 4 Link is for supplemental information purposes only It may not be used as the sole basis of therapeutic decisions Precautions during configuration WARNING Always adjust audible alarm volume to a level that ensu res the operator will be alerted when alarms occur Failure to identify and correct alarm situations may result in patient injury Precautions during care procedures WARNING To avoid risks to hospital staff and patients disinfect and c
104. d on ambient temperature The capacity and condition of the battery cannot be determined by the DC power pack The green battery symbol indicates that the battery is fully charged Even though the green symbol lights up the capacity of old or defective batteries may be so small as to permit operation of EvitaXL for no more than a few minutes WARNING It is mandatory and responsibility of the user to ensure sufficient battery capacity See Battery Maintenance 56 Battery Maintenance To ensure maximum battery life Batteries should always be fully charged and if possible never become deep discharged If the DC power pack is not used Connect the ventilator to mains power after not more than one month and switch it on for at least two hours in order to recharge the integrated battery Then fully recharge any external batteries which may be connected If the battery needs to be left uncharged for more than one month Have the integrated and external batteries electrically disconnected from the ventilator by DraegerService or factory trained and authorized personnel in order to reduce self discharge of the batteries Before reconnecting integrated and external batteries check that their capacity is still adequate They may have become exhausted or damaged as a result of prolonged storage Batteries are wear parts and must be replaced in a manner consistent with their degree of use CAUTION The c
105. d using pressure limit Pmax without impairing the sigh function During the sigh phase the Volume not constant alarm is disabled 200 Flow VT t without spontaneous with spontaneous breathing breathing Paw Sigh phase Pins p a mmm interm PEEP 7 PEEP 01837547 01937547 pa Sn i Xera suononsysu 8unejedo Operating Instructions EvitaXL 1 US ed SIMV Synchronized Intermittent Mandatory Ventilation Combination of ventilator breaths and spontaneous breathing SIMV enables the patient to breathe spontaneously during predefined regular ventilation pause intervals while mandatory mechanical breaths provide a minimum ventilation during the remaining cycle time Minimum ventilation is controlled by setting two parameters tidal volume VT and ventilator rate f It is then the result of the product of VT x f The ventilation pattern results from the set values of VT Insp Flow breath rate f and inspiratory time Tinsp The flow trigger of the ventilator ensures that a ventilator breath is triggered in synchrony with a patient s spontaneous inspiratory effort within a trigger window This prevents mandatory ventilator breaths from being applied during spontaneous expiration The duration of the trigger window is 5 seconds in adult patient mode and 1 5 seconds in pediatric mode respectively If the expiratory time is less than 5 secon
106. dby Mode Press Start Standby key j n EvitaXL displays the Start Standby Stand by activated Sta dby menu Confirm Standby Touch Alarm Reset and confirm E e Touch yellow Standby screen key 5 digi PEEP ORE Press dial knob to confirm the key Evita XL Standby Nds T m turns green ES ex P 1 Touch Alarm Reset screen key in rm the field for alarm messages at the Special top of the screen Start Standby XJ umn Va E New Current Press dial knob to confirm the key Patient jpatient o MP 7 20 turns green Ventilation begins with the current settings EMI Dm MV n B Standby The ventilator is now in standby mode PATENI T Ideal Body Weight eae Mask MON e E If the patient mode or ideal body weight Patient oo weight is changed in standby mode EvitaXL Mise PT will determine new start values for L Vs ventilation see page 65 SIMV AutoFlow vr 450 L PEEP 5 cmH20 iS F 15 ATC off Tinsp 1 7 sec O2 36 Vol96 Application tube E 10 bpm Psupp 6 cmH20 lz D 65 Ext lll Int Terminating standby mode To continue ventilation Touch Start screen key the key EC turns yellow I ir PEEP Mee e Check settings Evita XL Standby 8 Mai O Press dial knob to confirm vx Ec The menu disappears and is Data replaced by the main screen Pi T EvitaXL starts ventilation Start Standby ERI limi my Procedure EB T m e Y 290 Ventilation
107. de who can breathe sufficiently on their own especially when alarms have been manually disabled When masks are used dead space increases Always follow the mask manufacturer s directions to properly deal with the increased dead space caused by the mask Apnea cannot always be detected reliably SpO2 monitoring must be use if available Avoid high airway pressures Risk of aspiration After changing from Mask mode to Tube mode al ways check and adjust alarm limits and ventilator set tings if necessary to ensure that ventilation is monitored comprehensively All ventilation modes except ILV can be selected in Mask mode NOTE Automatic tube compensation option ATC activated in Tube mode is not in effect in Mask mode Operation NIV Mask Ventilation Available Option 93 Operation Using NIV Selecting Mask mode Mask mode can be selected when switching on or during operation O Press Start Standby key In the menu Start Standby Touch Standby screen key it will turn yellow Press dial knob to confirm The key turns green and the ventilator is now in standby mode Touch the screen key Tube Mask and touch 4 Mask NIV screen key The key turns yellow Press dial knob to confirm The key turns green and the ventilator is now in Mask mode Setting ventilation parameters for NIV As described for Tube
108. ds or 1 5 seconds in pediatric mode the trigger window covers the entire expiratory time Synchronization of mandatory ventilator breaths by itself effectively reduces SIMV time which would result in an undesirable increase in the effective IMV rate EvitaXL therefore extends the subsequent time allowed for spontaneous breathing by the lost time difference AT thus preventing an increase in the SIMV rate The mandatory breathing rate f together with tidal volume VT responsible for minimum ventilation is kept constant If the patient has inspired a significant volume at the beginning of the trigger window the ventilator reduces its subsequent mandatory breath by shortening the time for the inspiratory flow phase and overall inspiratory time Tidal volume VT remains constant and overinflation of the lungs is avoided During the spontaneous breathing phases the patient can be assisted with pressure using Pressure Support As part of progressive weaning the breath rate f is further reduced on the ventilator thus extending the periods of spontaneous breathing until the required minute volume is eventually supplied entirely by spontaneous breathing Theory of Operation Ventilation Modes synchronised spontaneous mandatory breathing stroke mandatory ventilation Paw PEEP T ze trigger D window Tinsp Spontaneous breathing time t Spontaneous time AT set IMV tim
109. duct requires full understanding and strict observation of all portions of these instructions The equipment is only to be used for the purpose specified under Intended Use on page 20 and in conjunction with appropriate airway monitoring see page 23 Observe all WARNINGS and CAUTIONS as rendered throughout this manual and on labels on the equipment 20837547 This page intentionally left blank pa Sn Lb Xera suononasu 8unejedo Contents pa SN L Xera suononaisu Bunesado This page intentionally left blank pa Sn Lb Xera suononasu 8unejedo Operating Instructions EvitaXL 1 US ed Operator s Responsibility for Patient Safety 0 cece eee 8 Limitation of Liability nai idi ILC Dan baw eed ees 8 Warranty e e A A cd ee re Han acc EAR 9 Definitions oe eee nte t ee deed ise br iet bre v Ri 10 Summary of WARNINGS and CAUTIONS 00 00 cece eee eee 11 Important Safety Information Operator s Responsibility for Patient Safety Limitation of Liability Important Safety Information Operator s Responsibility for Patient Safety WARNING Strictly follow this Operator s Instruction Manual Any use of the product requires full understanding and strict observation of all portions of these instructions The equipment is only to be used for the purpose specified under Intended Use on page 20 and in conjunction with appropriate airway monitoring see page 23 Observe all WARNINGS a
110. during an pressure support breath Expiratory tidal volume Inspiratory tidal volume Volume trapped in the lung by intrinsic PEEP and exhaled during subsequent expiration Theory of Operation Abbreviations 219 Theory of Operation Symbols Symbols Symbols A Alarm Silence Alarm Limits Bi Ventilator Settings Sensor Parameter omo System Setup Start Standby e Main screen mmu COIN ce Freeze FO Nebul ii mE FO ext int E 220 Explanation Suppress audible alarm for 2 minutes Set alarm limits Settings for ventilation Sensor calibration Configuration Standby ventilation Back to main screen Select different sets of measured values Freeze Display alarm limit in trend Nebulizer active Real time waveforms loops and trends Breathing gas humidifier HME heat and moisture exchanger AC power External battery Internal battery Lower alarm limit Upper alarm limit Install flow sensor Pressure rise time for Pressure Support Direct access to settings unlocked locked Adult mode Pediatric mode Neonatal mode Supplementary information Quit menu Refer to Operating Instructions Protection class type B Protection class type BF Spontaneous breathing activity by the patient Nurse call Tube compensation activated pa Sn i Xera suononasu 8unejedo Operating Instructions EvitaXL 1 US ed Refer
111. e 10 08 2001 Date 0 cmH20 10 34 10 08 2001 Operation Diagnostic Functions Yol FiO 3 5 Data Special Limin mv WEA dz Y 20 Limin MV spr bpm frota L Vri 450 igi 2 65 Ext 3l Int 115 13737547 Operation Sensors Sensors EvitaXL uses the following sensors for measurement and monitoring Flow sensor Pressure sensors O2sensor CO2 sensor available option The last sensor calibration values obtained are saved until the sensors are calibrated again even if the ventilator was switched off in the meantime The pressure sensors for measuring airway pressure are calibrated automatically The flow sensor and the O2 sensor are automatically tested every day The flow sensor may be calibrated at any time even during ventilation The O2 sensor may be calibrated at any time even during ventilation and without affecting the applied O2 concentration Calibration of the optional CO2 sensor may also be checked during ventilation Flow sensor calibration after replacing the flow sensor EvitaxL cleans the flow sensor automatically before it is calibrated EvitaxL also automatically cleans and calibrates the flow sensor after use of the nebulizer WARNING The hot wire in the flow sensors is heated well above its normal operating temperature during the cleaning process Therefore avoid flammable gases e g ethanol vapors after disinfection
112. e EvitaxL ventilator unit Fill nebulizer in accordance with its respective Instructions for Use WARNING Consider effects of aerosols on sensors filters and heat and moisture exchangers HMEs The measuring function of the flow sensor may be impaired The flow resistance of filters is liable to increase and may impair ventilation Do not put a microbial filter on the nebulizer outlet when in use Operation Special Functions ak 000 00 107 03637376 03737376 03737376 03937376 Operation Special Functions WARNING Do not use a heat moisture exchanger simultaneously with a nebulizer or heated humidifier Risk of increased breathing resistance due to condensation To switch nebullizer on Touch Special Procedure screen function key EvitaxL displays the menu Additional Function Touch 3 Nebulizer screen key the key turns yellow Press dial knob to confirm The key turns green and the nebulizer is now in operation The message Nebulizer On appears on screen To switch nebulizer off Touch 3 Nebulizer screen key The ventilat
113. e gt set IMV time 1 1 f f 201 02037547 Theory of Operation Ventilation Modes MMV Mandatory Minute Ventilation In contrast to SIMV the MMV ventilation mode provides mandatory breathing only if spontaneous breathing is not yet Paw sufficient and has fallen below a preselected minimum minute ventilation ASB pressure support Pmax configurable short long rise time rise time This minimum ventilation is controlled by the two set values of tidal volume VT and ventilator rate f as a result of the product VT xf gt trigger phase T Unlike SIMV mandatory breaths are not applied regularly but only during periods of insufficient ventilation T Flow The frequency of mandatory breaths is determined by the level y of spontaneous breathing if spontaneous breathing is ate sufficient mandatory breaths are not used at all If spontaneous breathing is not sufficient intermittent mandatory breaths of the set tidal volume VT are applied With no spontaneous breathing at all the mandatory breaths 01137547 are applied at the set rate f EvitaXL continuously balances the difference between spontaneous breathing and the set minimum ventilation As soon as the balance becomes negative due to insufficient spontaneous breathing EvitaXL applies a mandatory ventilator MV breath at the set tidal volume VT so that the balance is again positive MV spontaneously brea
114. e faulty CO2 sensor CO2 zero n Zero point for CO2 measurement is outside the permissible range Perform zero calibration page 120 Zero calibration for CO2 measurement was unsuccessful Perform CO2 zero calibration correctly page 120 Device failure n Device faulty Ventilation may be continued if the message disappears when the Alarm Reset key is pressed If it does not disconnect patient from the ventilator and continue ventilation immediately with another independent ventilator Use PEEP and or elevated O2 concentration as necessary Call DraegerService etCO2 high m CO2 measurement above upper alarm Check patient condition limit for end expiratory CO2 concentration Check ventilation pattern Correct alarm limit if necessary etCO2 low m CO2 measurement below lower alarm limit Check patient condition for end expiratory CO2 concentration Check ventilation pattern Correct alarm limit if necessary Execute device check Device check not performed Perform device check page 46 Confirm message with Alarm Reset key Exp hold interrupted The Exp hold key has been pressed for more than 15 seconds Release Exp hold key Exp valve inop Tm Expiratory valve not properly connected to socket Push expiratory valve firmly into socket until it clicks into place Flow sensor not calibrated or faulty Calibrate flow sensor pa
115. e stable and would be destroyed Disinfect the flow sensor in 70 96 ethanol solution for approximately 1 hour WARNING Vent flow sensor after disinfection with ethanol for at least 30 minutes or rinse with sterile water Otherwise residual ethanol vapors might ignite and destroy the sensor during calibration NOTE The flow sensor may be reused as long as automatic calibration is possible 148 m vita xL Q O 000000 E 17537376 17637376 05337376 pa Sn L Xera suononasu 8unejedo Operating Instructions EvitaXL 1 US ed Expiratory valve 1 Push catch to the right while 2 pulling out the expiratory valve at the same time If the expiration valve is equipped with an optional water trap Pull off the collecting jar The expiratory valve is only dismantled if severely soiled Unscrew cover lid by hand and remove together with the diaphragm CAUTION Do not disassemble expiratory valve beyond removing diaphragm Prepare expiratory valve for disinfection and cleaning in an automatic parts washer and disinfection machine and prepare for autoclaving Always place an opened expiratory valve into a disinfection or autoclave tray so it will not be damaged by other
116. e symbol for patient mode The flow trigger is set with the parameter Flowtrigger To set Touch Add settings screen key in the respective ventilation mode EvitaxL displays the possible supplemental settings Touch Flowtrigger screen key EvitaXL displays the menu for setting the flow trigger e Touch Trigger screen knob Turn dial knob to set press dial knob to confirm e To activate deactivate the flowtrigger Touch On or Off screen key respectively then press dial knob to confirm NOTE The flow trigger may only be disabled in the CMV ventilation mode Overview ATC Flow Auto A trigger Flow Eum 60 cmH20 n Freeze A Lt 50 Limin Flow E ge i A a 0 50 Ventilator Settings 2 4 x SIMV PC CPAP Ps APRV more a CHEM I NEN 1 Flowtrigger EB 0 Trigger settings Operation Flow trigger Pmean PEEP 123 10 5 100 Values e Main Vol 96 FiO Data S on MV Procedure 4 5 s Limin MV spr 0 bpm Flota 10 Limin 63 Ext Int 85 19137547 Operation Apnea Ventilation Apnea Ventilation For automatically switching over to volume controlled mandatory ventilation if the patient stops breathing Apnea ventilation can be activated in the ventilation modes SIMV PCV CPAP and APRV EvitaXL renders an apnea alarm if either no expiratory flow is measured
117. e warranty provided by Draeger Medical Inc No other warranty expressed or implied is intended Representatives of Draeger are not authorized to modify the terms of this warranty Draeger Medical Inc Telford PA Important Safety Information Definitions Definitions WARNING A WARNING statement refers to conditions with a possibility of personal injury if disregarded CAUTION A CAUTION statement designates the possibility of damage to equipment if disregarded NOTE A NOTE provides additional information intended to avoid inconveniences during operation Inspection examination of actual condition Service measures to maintain specified condition Repair measures to restore specified condition Maintenance inspection service and repair where necessary Preventive maintenance measures at regular Maintenance intervals Typing conventions in this manual Controls are designated as Control Name e g PEEP Screen pages are indicated as Screen pagex e g Measured values Screen messages are printed in bold e g Flow Calibration Screen messages rendered throughout the text are shown including the exclamation marks indicating their alarm level e g Standby activated Abbreviations and Symbols Please refer to Abbreviations on page 216 and Symbols on page 220 for explanations Labels on the equipment Please refer to Labels on page 177 10 pa Sn Lb Xera suononasu 8u
118. ective screen key and press dial knob to confirm Operation ILV Paw Insp pause epe Vy configu PEEP rable Tinsp Te Flow a f Insp flow gt t 60 Limin Paw Preis PEEP 10 5 Yol FiO Flow 4 L min MV A A 4 5 25 50 Y Y Vv Synchronisation with E Ventilator Settings X bem iota a Bises CPAP PS APRY use 1 0 Overview ATC Sigh ane E L Vn settings Asynchron Inverse Add 45 0 15 settings Li eroe 123 WW Values e Main Data Special Procedure ES Ext Int 75 0053754 18437547 Operation ILV ILV Master and Slave Synchronization Master device I E ratio Slave device Sync The I E ratio of the slave device is determined by the I E ratio of the master device The start of inspiration is synchronised with the inspiration of the master device Slave device Async The start of inspiration is synchronised with the inspiration of the master device The end of inspiration incl pause time is determined by the Tinsp setting The I E ratio of the slave device is freely selectable Slave device Inverse The start of inspiration is synchronised with the start of expiration of the master device and vice versa The I E ratio of the slave device is the inverse of the I E ratio of the master device 76
119. eference loop E 5 a m 0 Main Touch Ref screen key at the e Single volse Fio desired time to record a reference 00 is 35 Ens loop n 0 20 40 cmH2O 225 200 400 600 L Special Limin Flow Limin MV Procedure The reference loop is drawn in blue and 2 de appears continuously in the current loop p 4 5 A is 20 display The time at which the reference e UER MV loop was recorded appears on the left beside the Ref key S 0 7004 Vo a bpm Flota ee To freeze loops see Freeze aa 1 0 page 100 300 A A T ne 100 X 450 The Ref screen key is not in effect B 3 a ii d u 18 sec i when the loop has been frozen using o Qo o o O Apnea vent On 10 25 aT D Freeze eS ext NE O2 Vr Tinsp f PEEP Psupp lij liis 101 12337547 Operation Displaying Graphics Displaying 1 hr trends Touch da Touch the desired pj screen key Main screen key e Touch Trends screen key EvitaXL now shows a menu for selecting parameters for the display of trends Touch the desired parameter key EvitaxL displays the trend for selected parameters overthe last one hour To view a value in the trend at a certain point in time Turn dial knob to position the cross hair cursor over the desired point The value is displayed at the top in the trend display NOTE The cross hair cursor cannot be moved if the trend has been halted with C Freeze 102
120. en stop To view a waveform value at a certain point in time or a pair of values in a loop Turn dial knob to position the cross hair cursor over the required point and the corresponding measured value or pair of values will be displayed above or beside the waveform or loop respectively EvitaXL ends freeze mode automatically three minutes after touching the screen key or three minutes after the dial knob was last turned To continue viewing new waveforms loops Press Freeze screen key again the current waveforms or loops are once again recorded Displaying loops This mode is used to display two measured values which appear as a loop for each ventilation cycle such as the Paw V loop or the Flow V loop Touch Touch the respective screen key a ee Touch Loops screen key EvitaxL displays the Loops menu Main screen key Loops may be displayed in different configurations Two small loops one on the left the other one on the right or An enlarged loop on the left 100 gp Pn H20 Paw 5 Paw O m Le 50 min Flow 0 Flow 4 ies 25 0 25 50 mb v 0 V mm Le 500 300 100 0 0 2 4 6 8 10 42 14 16 sec Apnea vent On 10 25 Q e o e Q KE Oz Vr Tinsp i ESER Psupp Press vol Limin Limin bpm 10 35 4 5 s 0 PEEP 123 5 100 Values e Main FiO Data Special MV Procedure MVepn Flota ES
121. ences 1 Baum M Benzer H Mutz N Pauser G Tonczar L Inversed Ratio Ventilation IRV Die Rolle des Atemzeitverh ltnisses in der Beatmung beim ARDS Anaesthesist 29 1980 592 596 2 Geyer A Goldschmied W Koller W Winter G St rung der Ger tefunktion bei Anbringung eines Bakterienfilters in den Exspirationsschenkeln des Beatmungssystems Anaesthesist 34 1985 129 133 3 Baum M Benzer H Putensen Ch Koller W Putz G Biphasic Positive Airway Pressure BIPAP eine neue Form der augmentierenden Beatmung Anaesthesist 38 1989 452 458 4 Luger Th J Putensen Ch Baum M Schreithofer D Morawetz R F Schlager A Entw hnung eines Asthmatikers mit Biphasic Positive Airway Pressure BIPAP unter kontinuierlicher Sufentanil Gabe Anaesthesist 39 1990 557 560 5 Hensel l Atemnotsyndrom nach Beinahe Ertrinken Rettung durch neuartiges Beatmungsprogramm Rettungsdienst 11 Nov 1991 737 739 6 Meyer J Neue Beatmungsformen An sthesiol Intensivmed Notfallmed Schmerzther 26 1991 337 342 7 Vincent J L Yearbook of Intensive care and Emergency Medicine Springer Verlag 1993 8 Stock M C Downs J B Frolicher D Airway pressure release ventilation Critical Care Medicine 15 1987 462 466 9 R s nen J Cane R Downs J et al Airway pressure release ventilation during acute lung injury A prospective multicenter trial Critical Care Med
122. end of the last 20 minutes on the left next to the real time waveform The other two real time waveforms are also automatically combined with a short trend If no new parameters have been selected for the short trends EvitaXL will display the parameters previously selected for the short trend 500 300 A00 50 40 20 10 Limin 50 700 0 Apnea vent On 10 25 o AL A P x Curves Loops Trends Flow Volume Curve only co Curve Shorttrend SE Flow 25 h o 25 y 50 k V 0 2 4 6 8 10 16 sec 12 14 Tinsp f Operation Displaying Graphics SIMV AutoFlow Yol Limin Limin bpm 4 5 A T 5 100 alues Main Data Special Procedure MV MV spn totai 63 Ext Int 60 emH20 40 20 o 20 min cmH20 40 20 10 20 min 700 500 300 100 20 min Apnea vent On Pmean Ppeak now Flow Limin Freeze ta gt Vol 96 Limin Limin bpm 35 4 Mn Values 5 Mit e Main Data Special Procedure MV 5 15 Y 20 MV 0 Flota 63 Ext Int 99 12037547 14637547 Operation Displaying Graphics Freeze To freeze a current real time waveform or loop Touch Freeze screen key it turns dark green with a red symbol The momentary waveforms and loops are recorded and th
123. er trap straight D 700133 Expiratory valve patient block 84 10 580 O2 supply filter and water trap straight D 700131 Water trap for expiratory valve 84 13 125 EvitaMobil trolley high i with column extension 50 mm 84 14 455 d D im atient circuit adu Cabinet 8H 14 2 high 4 drawers M 31 796 for use with Fisher amp Paykel humidifier 84 06 550 Cabinet 4H 2 drawers M 31 795 Cuvette adult 68 70 279 EvitaMobil cylinder holder set 84 11 970 Cuvette pediatric 68 70 281 alternatively for installion in mobile cart Reol Mum eplacement parts Air compressor 84 13 890 E O2 sensor capsule 68 50 645 Flow sensor set of 5 84 03 735 224 pa Sn L Xera suononasu 8unejedo Operating Instructions EvitaXL 1 US ed Name Description Order No Set of ambient air filters cooling air filters set of 10 84 11 724 Lithium battery for data protection 18 35 343 For hinged arm Holder 84 09 746 Hose clamp 84 09 841 Ordering Information 225 Index Index A Abbreviations esses III 216 AC power iii a ee ner e Rue 54 59 AC DC operation sess 54 Alarm ii it ae Baebes Wes 97 volume aoi ians inoa ede tee ern ede ees 130 Alarm limits setting start up defaults oooooommmmm mo 143 Alarm audible cancel iaa daa da chia den e desees 98 Alarm power failure alarm seseeeeeeee 98 Ambient air intake filter removing aie eR nr Rr eae Mere a ea es 160
124. er traps and associated water jars Y piece temperature sensor These parts may be autoclaved at 134 C 273 F Nebulizer Process in accordance with its accompanying instructions for use Bacteria filter Must be processed in accordance with its accompanying Instructions for Use Breathing gas humidifier Must be processed in accordance with its separate Instructions for Use 152 05737376 pa Sn Lb Xera suononasu 8unejedo Operating Instructions EvitaXL 1 US ed Care Disinfecting Cleaning Sterilizing Schedule for the EvitaXL Intensive Care Ventilator Disinfecting Cleaning Sterilizing Schedule for the EvitaXL Intensive Care Ventilator Applicable for use with non infectious patients If the ventilator was used with infectious patients all parts that conduct breathing gas must be additionally sterilized after disinfecting and cleaning The breathing gas conducting parts listed here can be steam sterilized at 134 C 273 F See Sterilizing column This table is intended as a guideline only Always follow accepted hospital procedures and protocols for cleaning and disinfecting Part How often How Reusable Recommended Disinfecting and cleaning Sterilizing components reconditioning Autoclaving at Wiping Bath Steam intervals 93 C 10 minutes immersion 1
125. era suononasu 8unejedo Operating Instructions EvitaXL 1 US ed Operation Setting Ventilation Mode Extensions Setting Ventilation Mode Extensions The ventilation modes can be combined with the following special functions to optimize ventilation Flow trigger Apnea ventilation AutoFlow ATC Sigh PLV Ventilation mode extensions are accessed through the Add Settings screen key To view additional text information Touch screen key Special functions Ventilation mode Flow trigger Apnea AutoFlow ATC Sigh PLV ventilation CMV X X X X X SIMV X X X X X MMV X X X X ILV Master X X X X ILV Slave X X X PCV X X X PCV Assist X APRV X X CPAP PSupp X X X 83 Operation Setting Ventilation Mode Extensions To review activate or set In the menu Ventilator Settings Touch Add settings screen key EvitaxL displays the menu with the overview of supplemental settings available for the preselected or active ventilation mode Example Additional settings for CMV Touchthe respective screen key e g Flowtrigger EvitaxL displays the menu for setting values and for activation deactivation Touch screen knob turn dial knob to set then press dial knob to confirm To activate deactivate Touch On or Off screen key respectively then press dial knob to confirm 84
126. eriod e g 100 O2 Confirm message with key Alarm Reset Disconnect patient from the ventilator and continue ventilation immediately with another independent ventilator Use PEEP and or elevated O2 concentration if necessary Call DraegerService Leakage Not displayed in application mode Mask NIV Measured leakage minute volume MVleak is 20 higher than the minute volume measured on the expiratory side Check that patient circuit connections are leakproof Check that the tube is correctly fitted Loss of data Tm Lithium battery discharged The ventilator functions are not affected Ventilation may be continued Check settings Call DraegerService MEDIBUS COM inop The MEDIBUS cable has been unplugged during operation while using EvitaLink Re insert connector and secure it against disconnection with the two Screws MEDIBUS cable faulty Use a new MEDIBUS cable Interface faulty Ventilation my be continued Call DraegerService Mixer inop Tm Faulty O2 blender FiO2 can deviate considerably Disconnect patient from the ventilator immediately and continue ventilation with another independent ventilator without delay Use PEEP and or elevated O2 concentration as necessary Call DraegerService 169 Troubleshooting Message Cause Remedy Multi functional board inop The multifunction board for operating the nurse ca
127. ers may be used for estimating the likelihood of successful weaning EvitaxL calculates the following weaning indicators Occlusion pressure P 0 1 Rapid Shallow Breathing RSB index Negative Inspiratory Force NIF Occlusion pressure P O 1 Respiratory drive can be measured at the start of inspiration by measuring the mouth pressure during a short term occlusion within the first100 ms the pressure is not influenced by physiological reactions that would try to compensate for the occlusion e g reflexive interruption of breathing or increased respiratory drive In principle this pressure is also independent of the muscle strength of the diaphragm Therefore the negative mouth pressure P 0 1 after 0 1 seconds is a direct measure of neuromuscular breathing drive For patients with healthy lungs and regular breathing P 0 1 will be about 3 to 4 cmH20 A high P 0 1 signifies a high breathing drive which can only be maintained for a limited period of time P 0 1 values beyond 6 cmH20 e g for a COPD patient indicate impending exhaustion RMF respiratory muscle fatigue When weaning COPD patients off the ventilator measurement of P 0 1 can define the weaning point To measure P 0 1 EvitaXL keeps the inspiratory valve closed after one expiration and measures the airway pressure produced by the patient s inspiratory effort during 100 ms P1 The 100 ms time interval starts when a negative pressure of 0 5 cmH20
128. essure high 37 air supply high 38 apnea ventilation 39 Insp hold interrupted 40 loss of data 41 Flow monitoring off 42 Monitoring FiO2 off 43 Monitoring CO2 off 44 Monitoring SpO2 off 45 O2 supply high 46 fan 2 defect 47 malfunction fan 2 48 malfunction fan 1 49 SpO2 low 50 SpO2 high 51 pulse low 52 pulse high 53 no pulse 54 SpO2 sensor 55 SpO2 meas inop 57 battery not loaded 58 battery only for 2 min 59 int battery activated 60 ext battery wrong 61 PEEP valve inop 62 neo flow meas inop 63 standby activated 64 nebuliser on 65 Tidalvolume high 67 check evita 68 frequency ILV Slave 69 pressure limited 196 End of telegram EOT pa SN Lb Xera suononasu 8unejedo Operating Instructions EvitaXL 1 US ed Ventilation MOod s dd datada dera etre pide dota p Ses iet Pe RU ud oh tyne Salad 198 Meas remernls d ne rre tas t nn ead Pod ee e oe ne nis 207 Weaning Parameters prcat cenny aaa a A Inn 212 Intrinsic PEEP cerra db dd bb EA Y ERG RENS 214 Insp O2 Concentration When Nebulizing Pharmaceutical Aerosols 215 Abbreviations vehe s vt beers aed toe dia ope aca ath a iae eerta 216 Symbols A ee a IRE EAR RE Rp dss Sie pelos 220 References scu deat ea er em re CUR RA ele Boe PR oe ders 221 Special ASCII Characters Used 0 eee eens 222 197 Theory of Operation Ventilation Modes Theory of Operation Ventilation Modes Volume Contro
129. etting ina eEReleis ni he near ec 92 Power failure alarm ow eee 98 Power source display of o amer m cere sia Beate tate nate is 58 Power sources OVEIVIEW avi abo vere talado ss 54 USe of it eint Et xU eS 55 Preparation cli d I LIS 34 Pressure limited ventilation PLV sisse 92 Pressure limiting manual eee eee 198 Pressure reducer replacing eee tede rte ete dfe 159 Pressure support description ita ta 205 Setting erre reete 69 71 78 82 Priority level of alarm messages 164 R Rapid Shallow Breathing index RSB description 322 sccocbesb cos Cle e C o aa ES 213 Re assembly lere reb A e 154 References ajc 5 345 0546 lebe beer eder e 221 228 S Schedule disinfecting cleaning sterilizing 153 Soroen deli eet bes etel quis Moen Gee ad 27 brightness 3er dole hone pdas e 131 function key configuration ooooommmo 134 Screen knObs 2rd bed ese ee rr eames wear 30 Sensors sidad arias eed prag a arduis eps 116 Sl cette etaed esit aqui hoi ahaha tas 180 CUSTOMIZING 2 4 cgo e irse te Rote d 135 locking access 136 specific system 2 0 cc cece eee ees 130 Sigh descripti RR 200 A serrer ERE a e EE T 91 SIMV description 3 2 use arborea 201 SEINO dr dit bue satt oe Son cand 69 Solvents organic 17 150 Special functions 1 0 eee 106 defining start up defaults 00008 142 SONO sosssrezreniid doa arrasa
130. exchange The steepness of the increase from the lower pressure level to the upper pressure level is controlled by the rise time setting Slope The effective time for the increase in pressure cannot become greater than the set time Thigh Pressure Support Pressure support for insufficient spontaneous breathing The ventilator function for assisting insufficient spontaneous breathing is similar to that of an anesthetist manually assisting and monitoring a patient s spontaneous breathing by feeling the breathing bag The ventilator takes over part of inspiration with the patient maintaining control of spontaneous breathing The CPAP system supplies the spontaneously breathing patient with breathing gas even during weak inspiratory efforts Pressure support is started when the spontaneous inspiration flow reaches the set value of the flow trigger or at the latest when the spontaneously inspired volume exceeds 25 mL 12 mL in pediatric mode The ventilator then produces an increase in pressure up to the preselected support pressure Psupp which is adjustable to the breathing requirements of a patient The pressure rise time is adjustable from 64 milliseconds to 2 seconds With a rapid rise in pressure EvitaXL supports the patient s insufficient spontaneous breathing with a high peak flow With a slow rise in pressure EvitaXL begins gently with a regular inspiratory flow The patient has to contribute more to
131. from its cuvette Unplug sensor in the back of the EvitaXL ventilator 2 Remove CO2 sensor cuvette from Y piece 3 Remove ET tube connector from cuvette Wipe disinfect CO2 sensor see page 151 Condition the cuvette in an automatic parts cleaning and disinfection machine see page 151 146 Um 04937376 pa SN L Xera suononasu 8unejedo Operating Instructions EvitaXL 1 US ed Temperature sensor 1 Remove temperature sensor from Y piece or from its receptacle on the reusable pediatric circuit Do not pull on cable Unplug sensor probe in the rear of the EvitaXL ventilator Wipe disinfect temperature sensor see page 151 CAUTION The temperature sensor is not designed for disinfection in an automatic parts washer or for bath disinfection SpO2 sensor optional e Unplug connector from the back of the unit Wipe disinfect the SpO2 sensor see page 151 Nebulizer option 2 Remove nebulizer hose from the nebulizer and from the nebulizer port on the ventilator Detach nebulizer from the patient circuit adult patient circuit or Remove nebulizer from the infant patient circuit Pull catheter connector tapered ISO connector 215 211 from the nebulizer input Pull adapter tapered ISO connector 222 211 from the nebulizer output Pull corrugated patient circuit segment from the connector Dismantle and
132. ge 116 replace if necessary Expiratory valve faulty Replace expiratory valve 166 pa Sn L Xera suononasu 8unejedo Operating Instructions EvitaXL 1 US ed Troubleshooting Message Cause Remedy Ext battery polarity reversed External battery has been connected with wrong polarity while using DC Connect external battery correctly page 57 Ext battery Voltage high External battery has been connected with excessively high voltage while using DC Connect a 12 V or 24 V battery External Flow EvitaxL takes into consideration the externally supplied flow when monitoring correct operation of the flow measurement Deactivate calculation of the external flow see page 117 Fan failure Temperature in ventilator is too high Fan failure Check fan function clean or replace cooling air filter Check ambient temperature Disconnect patient from the ventilator and continue ventilation immediately with another independent ventilator Use PEEP and or elevated O2 concentration as necessary Call DraegerService Fan malfunction Temperature in ventilator too high Check fan function clean or replace cooling air filter Check ambient temperature Ventilation may be continued Call DraegerService FiO2 high WM O2 sensor not calibrated Calibrate O2 sensor page 119 Faulty O2 blender Ventilator functions are not affected Ve
133. h AC power The integrated battery is not recharged while the ventilator is being powered by the external battery For this reason Recharge the integrated and external batteries as soon as possible see Charging Batteries on page 55 WARNING Do not connect any AC powered equipment to the external battery connection socket of the ventilator 60 pa Sn Lb Xera suononasu 8unejedo Operating Instructions EvitaXL 1 US ed Operation Precautions During Operation ssssss I 62 Starting Ups or cma bata tage cage aeta avita rud E Le CI Re d Le 63 Setting New Ventilation Parameters sss 65 Setting Ventilation Modes sssssseee nn 67 COMM ves bib edt ada dada idad td as icut 67 SIMV SIMV PO iret reel edt te air dee decir dice din 69 MMV MMV PS osten Elec eee doe edits 71 WW asain etter aan tia atta nes d dp dou ad E eG dys ad Reece 73 PCV BIPAP PCV BIPAP P Supp 00 0c cece eee 78 POVt BIPAP ASSISE coito tac ent eere cape cat apd shar od Woe 80 APR Vei i ark A E Spates Se E arg 81 CPAP GPAP7P SUpD z iiia ieda aiita ii ame Hk dne ard iesus 82 Setting Ventilation Mode Extensions sss ee 83 FlowWtFIGger xtd a tp ee af d ac t aay oma idem n 85 Apnea Ventilation isas maiii aiea pina aa a a atak IIR 86 AutoFloW 22 sehe ete eb e eic lo a aae 88 yo abba tia daa tee tate de tt 89 NL A A A A hae Si Ps eee 91 PEV iore O 92 NIV Mask Ventilation Available Option
134. hase Pmax interm PEEP PEEP t CMV Adult gp 0720 Paw Press PEEP 123 aa 10 5 100 Values 40 a ZS e Main 20 Vol Y FiO 0 Data ss 35 Special gg U min Flow a Umin my Procedure pes E a Ha 4 5 15 a E Y 20 Limin MV spn 25 50 0 Ventilator Settings a X bpm fita a Rew A Dr o que 1 0 A Flow Auto Sopra ters ues eo sen Basic ls Vn settings EB 450 E settings c S us I Ext intPEEP E Int 91 11937547 20137547 Operation PLV PLV Pressure Limited Ventilation Supplementary function for adjustable limitation of pressure peaks using the Pmax pressure limit in ventilation modes CMV SIMV MMV and ILV Tidal volume remains constant as long as the pressure waveform shows a plateau and the flow waveform shows a brief flow pause between inspiration and expiration Activate deactivate pressure limitation Pmax see Setting start up defaults for O2 I E pressure on page 142 1 When pressure limitation is active the value for Pmax is shown in the real time waveform of PAW t as a blue line 2 The screen knob Pmax is additionally displayed in the menu Ventilator Settings Volume monitoring is active The alarm Vol not constant pressure limited is automatically triggered if the tidal volume VT can no longer be applied This visual and audible alarm may be muted with the Alarm Reset screen key at the top of the screen until the
135. he upper alarm limit of the applied inspiratory tidal volume VT has been exceeded during three consecutive ventilator breaths Check patient condition Check ventilation pattern Correct alarm limit if necessary Leak or disconnection Check that patient circuit and connections are leakproof Tidal volume high The inspiratory tidal volume VT has exceeded the upper alarm limit Check patient condition Check ventilation pattern Correct alarm limit if necessary Leak or disconnection Check that patient circuit and connections are leakproof Volume not constant Pressure limited Due to pressure limit or time limit the set tidal volume VT has not been applied Prolong inspiratory time Tinsp Increase inspiratory flow Flow Increase pressure limit Pmax Press Alarm Reset key to suppress the visual and audible alarm until the cause of the alarm is remedied VT high alarm off Only in application mode Mask NIV optional The upper alarm limit for the inspiratory tidal volume VTi has been deactivated in application mode NIV Set alarm limit for VTi to the desired value again 172 pa Sn L Xera suononasu 8unejedo Operating Instructions EvitaXL 1 US ed Control Panel due dria dedi dee dene de dede deed doge dte dede quate dca dee ductu d 174 Front Connections 1 0 0 cece ce Hen 175 Back Panel envoie dean ea dash data acd aic at c a
136. ible For disposal of spent sensor capsules see page 161 Clean or replace after 4 weeks see page 160 Disposal with normal domestic waste Replace every year see page 160 Disposal with normal domestic waste Replace every 2 years Service every 6 months in conjunction with the semi annual preventive maintenance inspection Replacement every two years at the latest to be performed by DraegerService or factory trained and authorized technical service personnel Check battery capacity every six months Replace battery if necessary Lead acid gel batteries should be disposed of as special waste see page 161 Service every 6 months in conjunction with the semi annual preventive maintenance inspection Check battery capacity every six months Replace battery if necessary To be replaced every 6 years by DraegerService or factory trained and authorized technical service personnel Complete overhaul every 6 years by DraegerService Every 6 months to be performed by DraegerService or factory trained and authorized technical service personnel 159 Maintenance User Replaceable Parts User Replaceable Parts Replacing the cooling air filter Clean or replace after 4 weeks Replace after 1 year at the latest 1 Remove cooling air filter from its frame in the back of the ventilator Replace or clean in warm water with detergent added dry well Insert cooling air filter into its frame taking care
137. icine 19 1991 1234 1241 10 Sassoon C S H Te T T Mahutte C K Light R W Airway occlusion pressure An important indicator for succesful weaning in patients with chronic obstructive pulmonary disease Am Rev Respir Dis 1987 135 107 113 11 Voigt E Comments on the Use of BIPAP with Case Study Dr ger Mitteilungen Medizintechnik aktuell 1 94 Theory of Operation References 12 Bahns E BIPAP Two Steps Forward in Intensive Care Ventilation Dr ger Thematic Booklet Order No 84 13 530 13 Burchardi H Rathgeber J Sydow M The Concept of Analgo Sedation depends on the Concept of Mechanical Ventilation Yearbook of Intensive Care and Emergency Medicine 1995 Springer 14 Sydow M Burchardi H Ephraim E Zeilmann S Crozier T Long term Effects of Two Different Ventilatory Modes on Oxygenation in Acute Lung Injury American Journal of Respiratory and Critical Care Medicine Vol 149 1994 15 Kuhlen R Hausmannn S Pappert D Slama K Rossaint R Falke K A new method for PO 1 measurement using standard respiratory equipment Intensive Care Med 21 1995 16 Yang K L Tobin M J A Prospective Study of Indexes Predicting the Qutcome of Trials of Weaning from Mechanical Ventilation The New England Journal of Medicine 324 1991 1445 1450 17 Tobin Jubran A Advances in Respirators Monitoring During Mechanical Ventilation CHEST 1999 116 S 1416 1425
138. ide is 4 5 L min and is also displayed uncompensated Otherwise leak compensation might obscure a low minute volume alarm EvitaXL is intended to generate an alarm in any case of low minute ventilation With leakage compensation the set VT directly determines the volume to be delivered to the patient 208 pa Sn Lb Xera suononasu 8unejedo Operating Instructions EvitaXL 1 US ed This example has however been simplified In fact the calculated leakage correction takes into account the pressures in the patient circuit A higher percentage volume is lost on the inspiratory side than on the expiratory side because the pressure during inspiration is higher The displayed leakage minute volume MVleak is based on the mean pressure Pmean Leakage minute volume MVieak also takes into account inspiratory leaks The sum of minute volume MV plus leakage minute volume MVleak therefore will exceed the minute volume actually delivered to the patient during inspiration Unlimited volume compensation is inappropriate EvitaXL compensates for losses of up to 100 of the set tidal volume VT Due to technical tolerances a small leakage minute volume may be displayed even for a tight patient circuit Leakage compensation in application mode Mask NIV Depending on the set patient mode EvitaXL compensates leakages up to the following values in order to detect a patient trigger Adult mode 30 L min Pediatric mode 15 L min
139. in an ade quate level of monitoring The opera tor of the ventilator must still assume full responsibility for proper ventila tion and patient safety when sensors and their respective alarm functions are deactivated O Press 3S Sensor Parameter key EvitaxL displays the Sensor Parameter menu Touchscreen key for the sensor to be switched off e g CO2 Touch Off screen key the key turns yellow Press dial knob to confirm the key turns green The values measured by the respective sensor disappear After replacing the sensor Switch monitoring function back on 126 ean 3 Freeze 1 0 5 Mii ves e Main 20 vol FiO 0 Data 10 Special Procedure Sensor Parameter Yimin MV Flow 02 coz 4 5 OS pd Zero calibration Su Zero Limin MV spn Manual calibration required a OT If the CO2 curve no longer returns to Check 0 zero after each inspiration sensor Calibration PP Fiota Monitoring en 1 0 When switching the monitor to Off it must be replaced by external L Vri monitoring 450 ue u 2 1 63 Ext alll Int 20737547 pa Sn L Xera suononasu 8unejedo Operating Instructions EvitaXL 1 US ed Selecting Standby Mode To perform the ventilator check To keep EvitaxL ready for operation while no patient is connected To change between patient modes NOTE No ventilation takes place in standby mode Operation Selecting Stan
140. in the following tables Settings 00 date FS dd FS FS mm FS FS yy FS 01 O2 setting FS nnn FS 96 02 Max inspiratory flow FS nnn FS L min 03 Insp tidal volume FS n nnn FS L 06 I E FS nn n FS FS 1 0 FS 06 I E FS 1 0 FS FS nn n FS 07 Max breathing pressure FS nnn FS mbar 08 Breath rate frequency FS nnn n FS 1 min 09 PEEP FS nn FS mbar 10 Psupp ASB FS nn FS mbar 11 Interm PEEP FS nn FS mbar 12 APRV Pow FS nn FS mbar 13 APRV P high FS nn FS mbar 14 APRV T low FS nn n FS s 15 APRV T high FS nn n FS s 16 Apnea Time FS nn FS s 17 Tachypnea warning FS nnn FS bpm 18 Flow Trigger FS nn n FS L min 19 Pressure increase rate FS n nn FS s 28 Pinsp FS nnn FS mbar 84 Ti FS nn nn FS s 194 Alarm limits 20 MV low limit FS nn nn FS L min 21 MV high limit FS nn nn FS L min 25 CO2 upper limit FS nnn FS mmHg 25 CO upper limit FS nn n FS 25 CO2 upper limit FS nn n FS kPa 26 CO2 lower limit FS nnn FS mmHg 26 CO2 lower limit FS nn n FS 96 26 CO2 lower limit FS nn n FS kPa 27 PAWLimit FS nnn FS mbar 29 Insp tidal volume high limit FS n nnn FS L 71 Tdisconnect FS nn FS s 80 Pulse high limit FS nnn FS bpm 81 Pulse low limit FS nnn FS bpm 82 O2 saturation high limit
141. ing the equipment must ensure that all equipment is adequately secured in accordance with applicable safety standards WARNING In case of malfunction of any of the built in monitoring a substitute must be provided in order to maintain an adequate level of monitoring The operator of the ventilator system must still assume full responsibility for proper ventilation and patient safety in all situations WARNING Back up ventilation with an independent manual ventilation device If a fault is detected in the EvitaXL ventilator so that its life support functions are no longer assured start ventilation using an independent ventilation device resuscitation bag without delay if necessary with PEEP and or increased inspiratory O2 concentration CAUTION Restriction of Distribution Federal Law and Regulations in the United States and Canada restrict this device to sale by or on the order of a physician Device for use in health care facilities only and exclusively by persons with specific training and experience in its use Precautions during preparation WARNING Always install components that have been cleaned and disinfected according to approved hospital procedures 12 WARNING Treatment of batteries and O2 sensor capsules Do not throw into fire Risk of explosion Do not force open Danger of bodily injury Follow all local state and federal regulations with respect to environmental protection whe
142. internal O2 analyzer of the ventilator WARNING The integrated nebulizer function of EvitaXL is designed for nebulizers with a nebulizing flow of 6 L min at 29 psi 2 bar for example nebulizer 84 12 935 white central body Other nebulizers may cause considerable devia tions in tidal volume and inspiratory O2 concentration 106 pa Sn Lb Xera suononasu 8unejedo Operating Instructions EvitaXL 1 US ed Prepare the nebulizer in accordance with its Instructions for Use For use when ventilating adults 1 Connect nebulizer to the inspiratory side temperature sensor side of the Y piece 2 Connect inspiratory circuit to nebulizer Place nebulizer in a vertical position Using clips supplied with patient circuits route nebulizer hose back to the ventilator along the expiratory circuit For use during pediatric ventilation 3 Insert tapered adapter ISO O15 O11 into nebulizer entry port 4 Insert tapered adapter ISO 022 11 into nebulizer output port 5 Connect corrugated silicone circuit segment part no 84 09 634 0 13 m to the nebulizer output port 6 Remove corrugated patient circuit element from the inspiratory port on the Y piece and connect to the inspiratory port of the nebulizer instead Attach the free end of the corrugated circuit installed to the expiratory port of the nebulizer to the inspiratory port of the Y piece 7 Connect nebulizer hose onto the nipple in the front of th
143. ion Ordering Information Name Description Order No Name Description Order No Humidifier accessories Basic ventilator Mounting brackets AREA 94 14 999 tor Fisher Paykel MR 370 84 11 074 Upgrade kit EvitaXL requires Evita 4 84 14 879 Temperature sensor 84 05 371 Options For CO2 measurement optional Communications kit 84 11 735 Test filter 68 70 281 SpO2 measurement kit 84 13 035 Calibration kit 84 12 710 NOOHDw 84 185631 Tost gas cylinder 5 Vol CO2 95 Vol N2 86 50 435 Breathing Support Package 84 13 562 CO main flow sensor 68 70 300 Mask v tilation NIV did Holder for parking CO2 sensor 84 12 840 Nurse call kit 84 14 476 Connector for connecting the nurse call 18 46 248 Special accessories CapnoPlus etCO2 measurement kit 84 13 780 Instrument tray 84 12 723 DE powerpack 84 13 034 Wall bracket module 2000 Type 13 DC connecting cable 84 13 135 alternative to mobile cart 84 08 613 Pneumatic pharmaceutical nebulizer 84 12 935 Adult size test lung 84 03 201 Accessories required for operation MEDIBUS cable 83 06 488 Hinged circuit support arm 84 09 609 Printer cable 83 06 489 or ILV cable 84 11 794 Quick stop support arm 2 2M 85 706 Battery cable set 84 11 822 High pressure O2 hose with filter 3 m 10 ft external lead acid gel type battery DISS 45 00 807 12 V 17Ah 2 required 18 43 303 High pressure Air hose with filter 3 m 10 ft DISS 19100 5808 Exchange parts for disinfection Air supply filter and wat
144. ion for at least 10 minutes provided that the integrated battery was fully charged Supply of AC power must be restored without delay To ensure that the battery is always fully charged Connect the ventilator to AC line power and switch it on WARNING Leave the ventilator connected to AC power only in well ventilated areas In sufficient concentrations the hydrogen generated when charging batteries may otherwise lead to an explosion Leave the ventilator in standby mode or start ventilation AC DC Powered Operation Operation with AC Line Power Operation With Integrated battery Operation with Integrated Battery The ventilator immediately switches over to operation with the integrated battery if the mains power supply fails without an external battery being connected or in case of a discharged external battery NOTE The integrated battery is merely intended for emergency use and not for normal operation The LED next to the symbol for the integrated battery lights up yellow The green LED next to the symbol for the integrated battery goes out as it is no longer fully charged The advisory message Internal battery in operation is displayed when the unit switches over to the integrated battery The time available for operation with integrated battery depends on its charge If the battery is fully charged operation can continue for at least 10 minutes A caution message is displayed after 8 min
145. ion phase Post oxygenation Valve response time To 90 Supply system for spontaneous breathing and pressure support Max flow rate Max inspiratory flow Equipment compliance with Fisher amp Paykel MR 730 humidifier and reusable silicone adult patient circuit Insp Resistance Exp Resistance Dead Space Volume incl CO2 cuvette Technical Data ATC Automatic Tube Compensation 5 to 12 mm 0 5 mm O to 100 96 1 96 2 5 to 8 mm 0 5 mm 0 to 100 96 1 96 time cycled volume constant pressure controlled 2 cycles every 3 minutes for 30 minutes automatic automatic max 3 minutes max 2 minutes 2 minutes lt 5 ms adaptive CPAP system with high initial flow 2 L s in 8 ms 180 L min lt 2 mL cmH20 lt 2 3 cmH20 L s lt 3 8 cmH20 L s lt 16 mL Performance Data 181 Technical Data Performance Data Equipment compliance with Fisher amp Paykel MR 730 humidifier and reusable silicone pediatric patient circuit Insp Resistance Exp Resistance Dead Space Volume incl CO2 cuvette Additional functions Inspiratory relief valve Safety valve Display of Measured Values Airway pressure measurement Max airway pressure Plateau pressure Pos end exp pressure Mean airway pressure Min airway pressure Range Resolution Accuracy O2 measurement in main flow inspiratory side Inspiratory O2 concentration FiO2 Range Resolution Accuracy Flow Measurement Minute Volume MV Sponta
146. irm Touch the respective screen key to set parameters for automatic tube compensation Adjust and confirm with the dial knob 142 50 Freeze S MV Adult AutoFlow SSS 40 4 Lt 20 0 10 System Setup x System Ventilation Pi APs PEEP Pi i insp upp Iman overview Overview 15 iJ 5 40 Pressure Patient Modes Range Pmax a Mode amp IVT f Settings Oe Vol 36 02 LE Alarm E Limits pressure Dr ger LE 1020 mici Add settings VT 500 L VT 050 L T 12 bpm f 29 bpm Ti 1 7 sec Ti 0 7 sec Flow 19 L min Flow B L min Pinean PEEP 10 Yol FiO2 35 Limin MV 4 5 A 2t Limin MVspn 0 bpm fita 10 Vri 12 5 100 alues O Main Data Special Procedure 63 Ext Int Freeze ta Qe SIMV AutoFlow Pmean PEEP System Setup System Ventilation AutoFlow On Apnea ventilation Leakage compensation EN om o Exp Comp on Off Tube comp ATC Comp i Tube type Trach Adult Ped Tube 1 D mm E a Overview Modes VT f O2 1 E pressure Add settings Overview Patient Range Mode amp Settings Alarm Limits TORES Yol FiO 35 L min MV 4 5 oe Limin MV 0 bpm frota 10 3 Vri 12 10 Values e Main Data Special Procedure 63 Ext Int 16437547 16537547 pa Sn L Xera suononasu 8unejedo Operating
147. irway pressures Risk of aspiration After changing from Mask mode to Tube mode al ways check and adjust alarm limits and ventilator set tings if necessary to ensure that ventilation is monitored comprehensively Important Safety Information Summary of WARNINGS and CAUTIONS WARNING Only switch off alarms if the safety of the patient will not be compromised by the absence of an alarm The operator of the ventilator system must still assume full responsibility for proper ventilation and patient safety in all situations WARNING Always check and restore alarm limits and ventilator set tings after changing from Mask to Tube mode in order to ensure comprehensive ventilation monitoring WARNING For breath rates below 12 bpm deviations from set oxygen concentration may be significantly higher in extreme cases These deviations cannot be monitored by the internal O2 analyzer of the ventilator WARNING The integrated nebulizer function of EvitaXL is designed for nebulizers with a nebulizing flow of 6 L min at 29 psi 2 bar for example nebulizer 84 12 935 white central body Other nebulizers may cause considerable devia tions in tidal volume and inspiratory O2 concentration WARNING Consider effects of aerosols on sensors filters and heat and moisture exchangers HMEs The measuring function of the flow sensor may be impaired The flow resistance of filters is liable to increase an
148. is measured as a result of the inspiratory effort A second pressure value P2 is activated after 100 ms Simultaneously the inspiratory valve is opened so that the patient can breathe again normally The occlusion pressure P 0 1 is the difference between the pressure values P2 P1 References 10 15 page 221 COPD Chronic Obstructive Pulmonary Disease 212 Paw CPAP Insp valve closed 100 ms po Insp valve open 0 5 mbar P1 P2 P 0 1 02537547 pe Sn L Xera suononasu 8unejedo Operating Instructions EvitaXL 1 US ed Rapid Shallow Breathing RSB Index The Rapid Shallow Breathing index RSB is the quotient of spontaneous breathing frequency spontaneously breathed breaths per minute and tidal volume RSB 1 min x Ly 2Pont 1 min Vr L The lower the RSB index for a patient with spontaneous breathing the more probably he or she can be weaned successfully The significance of the RSB index is due to the fact that patients who can be weaned successfully tend to have a lower spontaneous breathing frequency and a higher tidal volume than those who are not yet ready to be weaned In their 1991 study Yang and Tobin showed that the RSB index is an effective instrument for predicting the success of an attempt to wean the patient Patients with an RSB index lt 100 1 min x L were weaned with a probability of 80 while 95 of those with an RSB inde
149. is not set to more than 4 cmH20 PEEP will be applied automatically at 4 cmH20 This PEEP allows EvitaXL to detect any subsequent disconnection All other ventilation parameters remain unaffected Display on screen O2 enrichment 180 s The remaining time is counted down continuously Pre oxygenation lasts for a maximum of 180 seconds During this time EvitaXL waits for the disconnection associated with suction If no disconnection is detected within 180 seconds the oxygenation program will terminate After disconnecting for suction EvitaxL delivers a very small flow for the duration of suction in order to automatically detect the end of disconnection The time available for suction is displayed continuously on screen in seconds example Execute suction and reconnect 120 s If suction is completed and the patient reconnected within the time indicated EvitaXL will end the deconnection phase Automatic canceling of oxygenation program If there is still no reconnection after 120 seconds the oxygenation program is interrupted All alarms are immediately reactivated EvitaXL continues ventilating in the set ventilation mode After reconnection After reconnection EvitaXL continues to ventilate in the set ventilation mode but using 100 Vol O2 for another 120 seconds in adult patient mode and a 25 96 elevated O2 concentration in pediatric patient mode as post oxygenation Display on screen Final O2 enrichment 120 s
150. ith Pmax EvitaXL can prevent pressure peaks while maintaining the set tidal volume VT by means of the pressure limit Pmax The tidal volume VT remains constant as long as a pressure plateau Pplat is still detectable and the flow waveform shows a brief period of zero flow between inspiration and expiration EvitaXL performs this function by reducing Insp Flow upon reaching the set Pmax If the tidal volume VT can no longer be applied with the selected pressure Pmax due to reduced compliance a Volume not constant alarm is automatically generated 198 Paw Insp pause ae 7 configu PEEP rable Tinsp Te Flow ZN V ho Insp flow o t 00537547 pa SN L Xera suononasu 8unejedo Operating Instructions EvitaXL 1 US ed AutoFlow The AutoFlow function can be activated in the Add settings menu AutoFlow takes over the task of setting both Insp Flow and Pmax the screen knobs for these parameters are no longer displayed With AutoFlow inspiratory flow is automatically adjusted to changes in lung conditions C R and to the spontaneous breathing demands of the patient WARNING When using AutoFlow always set the alarm limit PAW T in order to generate an alarm in the event of an increase in airway pressure with reduced compliance The maximum delivered peak airway pressure is limited to 5 cmH20 below the
151. itive Pressure Ventilation Inversed Ratio Ventilation Ventilation with inversed ratio of inspiration expiration International standard for mechanical ventilators Lung Ventilation Ratio of Inspiration to Expiration Tube coefficient Degree of tube compensation set value List controlled universal interface driver program Draeger communication protocol for medical devices Mandatory Minute Volume Ventilation Minute Volume Leakage minute volume Spontaneously breathed minute volume Option for neonatal ventilation Negative Inspiratory Force Maximum inhalation effort Non invasive ventilation Negative temperature coefficient Theory of Operation Abbreviations 217 Theory of Operation Abbreviations Abreviation O2 P 0 1 PAW PCV BIPAP POV assist BIPAPassist PEEP PEEPi Phigh Pinsp Plow Pmax Pmean Pleth PLV Ppeak PPlat PS PSupp O2 f suction QRS R Reset Alarm RSB SB SIMV Slope SpO2 TApnea Te 218 Definition Set value for inspiratory oxygen concentration Vol 96 100 ms occlusion pressure Airway pressure Pressure Controlled Ventilation plus Ventilation mode for spontaneous breathing at continuous positive airway pressure with two different pressure levels Pressure Controlled Ventilation plus Assisted Ventilation mode for assisted ventilation with continuous positive airway pressure with two different pressure levels Positive End Expiratory Pressu
152. itoring feature of the ventilator if no proximal airway temperature monitoring is performed by the humidifier used during spontaneous breathing when the spontaneous breath rate has been exceeded 5 to 120 bpm if the set tidal volume VT could not be applied alarm limit linked to set value of VT if the applied tidal volume exceeds the alarm threshold inspiration is interrupted and the expiratory valve is opened 21 to 4000 mL if no breathing activity is detected 5 to 60 s adjustable in 1 second steps 100 V 10 to 240 V 10 96 50 60 Hz max 1 8 A max 3 2 A typically approx 125 W pa Sn Lb Xera suononasu 8unejedo Operating Instructions EvitaXL 1 US ed Ventilator fuses Range 100 V to 240 V Protection class Ventilator CO2 sensor sensor connected Temperature sensor sensor connected Gas supply O2 gauge pressure O2 connection thread Air gauge pressure Air connection thread Dew point Oil concentration Particle size Gas consumption of control system Output for pneumatic medicament nebuliser Automatic gas switch over Sound pressure level for free field measurement over a reflecting surface Dimensions W x H x D Basic ventilator unit Ventilator with mobile cart Weight Basic ventilator unit Electromagnetic compatibility EMC conforming to European Directive 89 336 EEC Classification as per EC Directive 93 42 EEC Addendum IX UMDNS code Universal Medical Device Nomenc
153. l lators or short wave treatment equipment in the vicinity of the ventilator may interfere with its operation and pose a risk of patient injury WARNING Do not use the EvitaXL ventilator in hyperbaric chambers Equipment malfunction may result with the risk of patient injury WARNING Never use flammable medications e g on the basis of ethanol or other substances based on flammable sol vents in the patient circuit Fire hazard Always provide adequate ventilation when using flammable substances for disinfection pa Sn L Xera suononasu 8unejedo Operating Instructions EvitaXL 1 US ed Ventilation Monitoring The built in monitoring features of the EvitaXL ventilator ensure appropriate monitoring of ventilation therapy and therefore detect any undesirable changes in the following ventilation parameters airway pressure PAW expiratory minute volume MV inspiratory tidal volume Vri inspiratory O2 concentration FiO2 inspiratory breathing gas temperature T apnea time breath rate expiratory CO2 concentration etCO2 optional Changes in these parameters may be caused by acute changes in the patient s condition incorrect settings and user error equipment fault conditions failure of power and gas supplies WARNING In case of malfunction of any of the built in monitoring a substitute must be provided in order to maintain an adequate level of
154. l characters are ignored See page 222 for a list of special ASCII characters used 192 pa Sn Lb Xera suononasu 8unejedo Operating Instructions EvitaXL 1 US ed Identification telegram The identification telegram contains the device designation and a list of all measured values sent in the data telegram It has the following structure Telegram header STX Start character 050 Identification number 0 Channel number Telegram body The body of the telegram first contains the device name ESC EvitaXL This is then followed by any number of blocks each separated by ESC Each block contains all the data pertaining to a measured value each separated by RS Each block has the following structure ESC signal No RS signal name long form RS signal name short form RS unit RS minimum RS maximum The following table lists the complete identification telegram Signal Signal name Short Unit Minimum Maximum No long form form value value 00 ime t h min 0 00 23 59 01 Exp tidal volume VTe L 0 000 2 000 02 Breathing Frequency f 1 min 0 240 03 Minute Volume MV L min 0 00 99 99 04 Peak pressure Peak mbar 0 120 05 Plateau pressure Plat mbar 0 99 06 pressure mbar 0 99 07 Minimum pressure Pmin mbar 20 99 08 Mean pressure Mean mbar 0 99 09 Insp O2 concentration FiO2 15 99 10 Compliance C mL mbar
155. l the problem has been resolved Air supply pressure not required when FiO2 100 Vol Message Cause Remedy Air supply down WM Air supply pressure too low Make sure pressure is greater than 3 bar 43 5 psi Air supply down Air supply pressure too low Make sure pressure is greater than 3 bar 43 5 psi Air supply pressure high Air supply pressure too high Ensure pressure is below 6 bar 87 psi Air supply pressure high Air supply pressure too high Air supply is not needed for FiO2 100 Vol Ensure pressure is below 6 bar 87 psi Airway obstructed The ventilator applies only a very small volume with each mechanical breath e g because the tube is blocked Check patient condition Check tube Patient fights against the mechanical breaths in pressure controlled ventilation with the result that set inspiratory pressure is reached with only a very small volume applied Check patient condition Check ventilator settings Neonatal flow sensor not installed in the breathing system Check patient condition Check ventilator settings Airway pressure high The upper alarm limit for airway pressure has been exceeded The patient is fighting the ventilator cough Check patient condition Check ventilation pattern Correct alarm limit if necessary Kinked patient circuit Check patient circuit and tube 164 pa Sn L Xera suononasu
156. lation Depending on the O2 concentration set the ventilator supplies the nebulizer with air oxygen or a mixture of air and oxygen Deviations from the set O2 concentration are thus kept as low as possible NOTE In extreme cases with a minimum inspiratory flow of 15 L min the deviations can be up to 4 Vol In order to avoid greater deviations the nebulizer is switched off at inspiratory flows below 15 L min During ventilation in pediatric mode Nebulizing of medication aerosols is possible in pressure controlled ventilation modes In volume controlled ventilation modes nebulizing is only possible while using the AutoFlow ventilation mode extension In contrast to nebulizing in adult patient mode aerosol is delivered continuously in pediatric mode Aerosol generated during expiration does not however reach the lung Depending on the O2 concentration set the ventilator supplies the nebulizer with air oxygen or a mixture of air and oxygen Deviations from the set O2 concentration are minimized NOTE It is recommended not to use the nebulizer while ventilating at breath rates below 12 bpm For breath rates above 12 bpm please consult the diagram on page 215 for delivered O2 concentration The maximum deviation from set O2 concentration is 4 Vol 96 WARNING For breath rates below 12 bpm deviations from set oxygen concentration may be significantly higher in extreme cases These deviations cannot be monitored by the
157. lation mode in effect at the time indicated in the highlighted line To view all settings for another line entry Turn dial knob to select the desired line Touchy x screen key to close the logbook 104 Freeze A dez Data x Values Logbook Trends Time Settings Events Alarms 17 09 11 14 02 30 3596 17 09 11 14 PEEP 7 5 cmH20 17 09 11 22 MV low II 17 09 11 22 VT 510 450 mL 17 09 13 48 Airway pressure high 11 Settings 17 09 02 11 14 Mode SIMY 02 35 Yol PEEP 7 cmH20 AutoFlow VT 310 LE Psupp 0 cmH20 Patient Adult Tinsp 1 7 sec f 10 bpm Slope 0 8 sec Flow 52 Limin Pinsp cmH20 Yol 35 Limin 4 5 vis Limin 0 10 bpm PEEP ili ST 5 e Main FiO Special MV Procedure MVspn Flota 65 Ext Int 12937547 pa Sn L Xera suononasu 8unejedo Operating Instructions EvitaXL 1 US ed Displaying Trends 1 24 hr Touch Data screen key Touch Trends screen key EvitaxL displays three trends with a common time scale one below the other To select a parameter or parameter combination desired for the trend display Touch the respective screen key E The menu for trends is displayed Touch the screen key for the desired parameter parameter combination Its trend is displayed and the menu disappears Select the common time scale in increments as 1 3 6 12 24 hr
158. lation valve Calibration flow sensor Device Mask F Flow sensor Check Calibration O2 sensor Humid bpm fista Humidification CO sensor zeroed iu pes Patient hoses fitted CO2 sensor Temperature sensor Check Function Ajir O2 switch over valve L Vri Safety valve Supply pressures Back up alarm 15 Ze igi 2 O E3 Ext E o Int 10137547 10237547 pa SN L 1Xe1 3 suononujsu Bueaedo Operating Instructions EvitaXL 1 US ed EvitaXL guides the user through each test procedure in a dialog format Questions are displayed in the information line below the Alarms field and must be answered by touching the screen keys Yes and No Alternatively instructions for performing tests may also be displayed The ventilator indicates a correct result with a checkmark v Faulty results are marked F Two dashes appear if a test is not performed In the event of deficient results F Eliminate the cause of the problem and touch the Repeat screen key NOTE Checks may also be skipped by touching the next test screen key if this is in accordance with accepted hospital procedures To start the test proceure Touch Check screen key displayed in the checklist The ventilator performs each test line by line NOTE Results obtained during these tests of readiness for operation as well as the calibration values for the sen
159. lature System Nomenclature for medical products STPD Standard Temperaturee Pressure Dry Technical Data Operating Data F 5 H 250 V IEC 127 2 2x Class Type BF R Type BF 43 5 psi 3 bar 10 to 80 psi 5 5 bar 10 96 at 60 L min peak flow 200 L min DISS male oxygen 43 5 psi 3 bar 10 to 80 psi 5 5 bar 10 96 at 60 L min peak flow 200 L min DISS male air 5 C below ambient temperature 0 1 mg m Dust free air filtered with filter size lt 1um Medical air or O2 approx 3 6 L min Medical air or O2 max 2 bar max 10 L min if one gas fails inlet pressure 22 psi the device switches to the other gas max 47 dB A 530 x 815 x 450 mm 20 9 x 12 4 x 17 7 580 x 1360 x 660 mm 22 8 x 53 5 x 26 0 approx 29 kg 64 lbs incl shelf Tested in accordance with EN 60601 1 2 Il b 17 429 Measured values based on standardized physical conditions 0 C 1013 hPa dry gas 187 Technical Data Materials Used Materials Used Part Appearance Material Reusable patient circuit Water traps Y piece Connector for temperature measurement Expiratory valve Housing closure Diaphragm CO cuvette Temperature sensor cable CO2 sensor cable milky transparent yellow transparent yellow transparent milky transparent white whitish and grey yellow transparent milky green or blue grey grey silicone rubber
160. le in CMV mode can the flow trigger be completely switched off CMV Assist gt CMV The steepness of the pressure rise from PEEP level to the inspiratory level can be even more closely adapted to the needs of the patient by adjusting pressure rise time Slope Start up procedure with AutoFlow When AutoFlow is switched on EvitaxL applies a volume controlled ventilator breath with minimum inspiratory flow and subsequent inspiratory pause The plateau pressure Pplat calculated for this ventilator breath serves as the startup value for inspiratory pressure under AutoFlow Sigh Sigh operates in the form of an intermittent PEEP in CMV CMV Assist and ILV The purpose of expiratory sigh during ventilation is to open collapsed areas of the lung or to keep open slow areas of the lung Since atelectatic alveoli have a longer time constant also caused by obstructed bronchioli increased airway pressure maintained over a longer period is required to open them Commonly a sigh breath is achieved by simply increasing the pressure level of a ventilator breath however due to the short time available the filling of the slow alveoli is only marginally improved In the EvitaxL the sigh operates during expiration with an intermittent PEEP for 2 breaths every 3 minutes Mean airway pressure is higher and a longer filling time can be expected In order to avoid lung overinflation pressure peaks during the sigh phase can be limite
161. lean ventilator after use Always use ventilator that has been cleaned and disinfec ted and has been successfully tested to be ready for ope ration 16 WARNING Always follow accepted hospital procedures for handling equipment contaminated with body fluids WARNING Sterilization of parts in ethylene oxide EtO may lead to a patient health risk Patients may become exposed to EtO that may have diffused into components WARNING To avoid any risk of infection for hospital staff or other patients clean and disinfect ventilator after use Follow all accepted hospital procedures for disinfecting parts contaminated by body fluids protective clothing eyewear etc WARNING Vent flow sensor after disinfection with ethanol for at least 30 minutes or rinse with sterile water Otherwise residual ethanol vapors might ignite and destroy the sensor during calibration CAUTION The temperature sensor is not designed for disinfection in an automatic parts washer or for bath disinfection CAUTION When removing a reusable patient circuit always grasp hoses by their sleeve never by the hose itself to avoid possibly tearing the hose at the sleeve or ripping it out of the sleeve CAUTION Flow sensor is not compatible with parts washer equipment and may not be autoclaved or steam sterilized It cannot withstand high temperatures and would be destroyed CAUTION Do not disassemble expiratory valve beyond
162. ll is faulty Acknowledge message with the Alarm Reset key The ventilator functions are not affected However correct operation of the nurse call cannot be guaranteed disconnect nurse call Call DraegerService Multi functional board inop The multifunction board for operating the nurse call is faulty Acknowledge message with the Alarm Reset key The ventilator functions are not affected However correct operation of the nurse call cannot be guaranteed disconnect nurse call Call DraegerService MV high m The minute volume has exceeded the Check patient condition upper alarm limit Check ventilation pattern Correct alarm limit if necessary Flow sensor not calibrated or faulty Calibrate flow sensor see page 116 replace if necessary Water in flow sensor Drain water trap in patient circuit Dry flow sensor Ventilator malfunction Disconnect patient from the ventilator and continue ventilation immediately with another independent ventilator Use PEEP and or elevated O2 concentration if necessary Call Dr gerService MV low WM The minute volume has fallen below the Check patient condition lower alarm limit Check ventilation pattern Correct alarm limit if necessary Stenosis Check patient condition Check tube Leak in patient circuit Establish leakproof patient circuit Flow sensor not calibrated or faulty Calibrate flow sensor see page 116
163. lled Ventilation With PLV and AutoFlow AutoFlow is a new supplemental function that controls inspiratory flow during mandatory ventilator breaths in the volume controlled ventilation modes CMV SIMV and MMV In order to better explain the improvement achieved by this function the conventional modes are explained first Classic volume constant mandatory ventilator breath In mandatory ventilator breaths without AutoFlow the Insp Flow parameter restricts inspiratory flow If the inspiratory flow is so high that the set tidal volume VT is reached before inspiratory time Tinsp has fully elapsed the inspiratory valve closes and the breathing gas supply stops The expiratory valve remains closed until the end of the inspiratory time Tinsp This phase the inspiratory pause can be identified in the PAW t waveform as the plateau Pplat This type of mandatory ventilator breath which for technical reasons is found in the same form in almost all intensive care ventilators has two serious drawbacks Ifthe lungs are extremely non homogeneous the pressure peaks can lead to the overdistension of specific lung areas and the limited inspiratory flow as well as the fact that inspiratory and expiratory valve are closed during the inspiratory pause may cause the patient to fight the ventilator unless the pattern of ventilation is regularly adapted to the needs of the spontaneously breathing patient Manual pressure limiting w
164. llow Press dial knob to confirm the key turns green EvitaXL will include the selected humidifier in its calculation of circuit compliance The yellow LED in front of the symbol forthe selected humidifier lights up in the status field Z Heated humidifier fil HME filter After changing the humidifer Perform leak test see page 50 Application Mode Selection Tube Mask Optional In standby mode Touch Tube Mask screen key The menu for selecting tube or mask is displayed NIV non invasive ventilation Touch the respective screen key it will turn yellow Press dial knob to confirm the key turns green The selected application mode is now active If qf mask NIV has been selected P Mask Ventilation is displayed See page 93 for details on using NIV Preparation Entering the Humidifer Type Application Mode Selection Tube Mask Optional Evita XL Standby acceptable 300 mL min Start Standby x New Current Patient Patient ve HME Type Rn W riter Start Standby Attention After changing the type of Tube humidification repeat the Mask airtight check Hani ifier Airtight Check Check Check Leakage 20 mL min Standby Pmean PEEP Yol FiO Umin MV ES Y 20 Limin MV spn bpm frota n Vii HO 4d Mii Values e Main Data Special Procedure 63 Ext Int 19737547 Start Standby x New Curren
165. llowing descriptions it is assumed that the patient circuit has been attached on the left hand side WARNING Do not place containers of liquids such as humidifier water reservoirs on top of or above the EvitaXL ventilator Liquids getting into the ventilator can cause equipment malfunction with the risk of patient injury Preparation Installing a Heated Humidifier 39 04137547 04237547 Preparation Ventilating Adults and Children Ventilating Adults and Children O Set the ventilator to breathing gas humidifier see page 51 Upward from 100 mL tidal volume VT Patient mode Adults WARNING Do not use a heat moisture exchanger simultaneously with a nebulizer or heated humidifier Risk of increased breathing resistance due to condensation Connecting the patient circuit WARNING To avoid any risk of electric shock in the event of faulty grounding of patient monitoring equipment do not use antistatic or electrically conductive patient circuits 1 Attach circuit support arm to the rail on the left hand side of the ventilator and tighten screws Connect ventilator circuit segments of appropriate lengths lengths suggested are in meters Install water trap s in vertical position C
166. mL BTPS 1 mL 8 of measured value 0 to 150 bpm 1 bpm 1 bpm approx 35 s 18 to 51 C 1 1 C 0 to 100 mmHg or 0 to 13 3 Vol or O to 13 3 kPa 1 mmHg or 0 1 Vol 96 or 0 1 kPa 2 mmHg 5 96 of measured value lt 25 ms max 3 minutes Technical Data Performance Data 183 Technical Data Performance Data CO2 production V CO2 Range Resolution Accuracy T10 90 Serial dead space Vds Range Resolution Accuracy Dead space ventilation Vds VT Range Resolution Accuracy Computed value displays Compliance C Range Resolution Range 0 7 to 99 9 mL cmH20 Range 100 to 200 mL cmH20 Accuracy Resistance R Range Resolution Range 3 to 99 9 mL cmH20 Range 100 to 200 mL cmH20 Accuracy Leakage minute volume MVleak Range Resolution Accuracy T10 90 Rapid Shallow Breathing RSB Range Resolution Accuracy 0 to 999 mL min STPD 1 mL min 9 of measured value 12 minutes 0 to 999 mL BTPS 0 1 mL greater of 10 of measured value or 10 mL 0 to 99 1 10 of measured value 0 7 to 200 mL cmH20 0 1 mL cmH20 1 mL cmH20 20 of measured value 3 to 200 cmH20 L s 0 1 cmH20 L s 1 cmH20 L s 20 of measured value 0 to 99 L min BTPS 0 1 L min or for values less than 0 1 L min 0 01 L min 18 of measured value approx 35 s O to 9999 1 min x L 1 min x L see measurement of VT and f C values may be considerably biased as spontaneous breathing increases
167. mage materials If in doubt ask the supplier manufacturer of the disinfectant cleaning agent WARNING Sterilization of parts in ethylene oxide EtO may lead to a patient health risk Patients may become exposed to EtO that may have diffused into components WARNING To avoid any risk of infection for hospital staff or other patients clean and disinfect ventilator after use Follow all accepted hospital procedures for disinfecting parts contaminated by body fluids protective clothing eyewear etc CAUTION The surface of the EvitaXL screen is made of Plexiglas polyacrylate Exposure to alcohol or agents containing alcohol will likely cause fissure cracks Ventilator without circuits gas supply hoses or tempera ture sensor Wipe disinfect with a disinfectant based on the suggested active ingredients Make sure to comply with manufacturer s instructions 150 pa Sn Lb Xera suononasu 8unejedo Operating Instructions EvitaXL 1 US ed Temperature sensor SpO2 sensor optional Wipe disinfect CO sensor and test filter optional Wipe off any soiling with cotton swabs in particular on the windows of the CO2 sensor Wipe disinfect e g with 70 ethanol CO2 cuvette optional Wipe off any soiling with disposable tissue and cotton swabs particularly the inside and outside of the cuvette windows Disinfect in a moisture saturated environment at 93 C 200 F for 10
168. mandatory ventilator breaths If IMV time was set to a value longer than the alarm limit TApnea 1 and if there is no spontaneous breathing between mandatory ventilator breaths the apnea alarm would be triggered regularly Example f 3 min MV time 20 seconds TApnea 15 seconds This system is designed to prevent mandatory ventilation being prematurely triggered in the event of irregular spontaneous breathing while providing an alarm in the case of extended low ventilation levels PCV BIPAP Pressure Controlled Ventilation Plus The PCV BIPAP ventilation mode is a pressure time cycled ventilation mode in which the patient can always breathe spontaneously PCV is therefore often described as a time cycled alternation between two CPAP levels The time cycled change of pressure provides controlled ventilation which is a form of pressure controlled ventilation PCV However the continuously available opportunity of spontaneous breathing allows the transition from controlled breathing to independent spontaneous breathing to take place smoothly during weaning without requiring any change in the mode of ventilation Both the change from expiratory to inspiratory pressure level as well as the change from inspiratory to expiratory pressure level are patient synchronized for easy adaptation to a patient s spontaneous breathing pattern The rate of the pressure level changes is kept constant even though synchronization occu
169. monitoring The operator of the ventilator system must still assume full responsibility for proper ventilation and patient safety in all situations WARNING Back up ventilation with an independent manual ventilation device If a fault is detected in the EvitaXL ventilator so that its life support functions are no longer assured start ventilation using an independent ventilation device resuscitation bag without delay if necessary with PEEP and or increased inspiratory O2 concentration Intended Use Ventilation Monitoring 23 24 This page intentionally left blank pa Sn Lb Xera suononasu 8unejedo Operating Instructions EvitaXL 1 US ed Control Panel e deed eed edle duda deed ed dpge delle didis daros 26 The SCHOO Mien ia user cogo dor dod sod dod od Eri roa dvi ora ge aus o A E GE aD 27 Fixed Function Kaysi 3 metet e abe edet dene deae edere 28 On Screen Controls esses n 28 25 Operating Concept Control Panel Operating Concept Control Panel AAA _ _ 000000 a rt a los f Pe ruse ae e on Drager EvitaXL The control unit is characterized by its um small number of operating elements its clear layout and easy operation mei Its main elements are 1 Alarge screen with all the information and controls needed for ventilation 2 Fixed function keys hard keys beside the screen for rapid access to m
170. n Nurse Call Available Option Nurse Call Available Option Connection on the rear panel of EvitaXL intended for the transmission of alarm signals to a central hospital alarm System WARNING Installation of the Evita nurse call kit should only be performed by DraegerService or factory trained and authorized service personnel Have a qualified electrician perform the installation of the round 6 way DIN female connector to the line of the central alarm system EvitaXL activates the nurse call by closing contacts 3 5 whenever a WARNING level alarm 3 exclamation marks is displayed 1 Connect plug to the receptacle marked T and secure S with screws 15 05 SE WARNING The operator of the ventilator must still assume full resposibility for ventilation monitoring via the EvitaXL Os screen when the nurse call is connected gt Only highest priority alarms will activate the nurse call Check screen displays frequently Alarm messages that are transmitted via nurse call are those indicated in red and with three excalamation marks in the top field of the EvitaXL screen Caution and Advisory level messages are not transmitted The nurse call is activated also E when the original enunciator in the ventilator is faulty or when X power is interrupted while the ventilator is in use 1
171. n disposing of batteries and O2 sensor capsules WARNING Draeger cannot warrant or endorse the safe performance of heat moisture exchangers The user must verify that the heat moisture exchanger is covered by a technical safety certificate which guarantees complete suitability for the intended use Do not use a heat moisture exchanger simultaneously with a nebulizer or heated humidifier Risk of increased breathing resistance due to condensation WARNING The flow resistance of bacteria filters placed in the expiratory side may be substantially increased by nebulized aerosols with the risk of impaired ventilation If an expiratory filter is used during nebulization airway pressures and flow should be monitored for any indication of increased expiratory resistance due to filter obstruction WARNING Draeger cannot warrant or endorse the safe performance of third party humidifiers that are not described in this manual for use with the EvitaXL ventilator Specifically the user must assess the risks of delivery of breathing gas not maintained at a proper temperature associated with different humidifier designs We strongly recommend using the electronic temperature monitoring feature of the ventilator if no proximal airway temperature monitoring is performed by the humidifier used Increased pneumatic resistance in the inspiratory line caused by a humidifier may result in less accurate airway pressure readings We recomme
172. n key VT f VT f as a function of patient weight Touch By Weight screen key EvitaxL displays the default values for VT and f for different weights In the line Start up by weight Touch On screen key and confirm with the dial knob Set values Touchcorresponding screen keys for Vr and f Adjustand confirm with the dial knob VT f as a function of the patient mode Touch By Patient screen key EvitaxL displays default values for VT and f applicable to adults and children In the line Start up by patient Touch On screen key and confirm with the dial knob Set values Touch the respective screen keys for VT and f Adjustand confirm with the dial knob To restore the manufacturer s default settings Touch Dr ger Default screen key Press dial knob to confirm Configuration Specific Initial Therapy Values 40 E 20 D 10 System Setup x System Ventilation 3 Overview Overview EB 3kg 15kg 65kg Start up by weight Ses Weight Patient vr L 003 110 450 700 vat Patient Range Mode amp Settings Alarm Limits Modes 100 kg Oz lE f bpm 28 de ye pressure Add settings Dr ger Default Vol96 Limin 4 5 s Limin bpm 4 E Jj PEEP 122 0 5 10 Values e Main FiO Data 3 5 Special MV
173. n key and a selection list is displayed Selectand confirm the default patient mode with the dial knob Specific Initial Therapy Values Freeze gt System Setup System Ventilation Start up values for patient range Start up values for ventilation parameters Start up values for alarm limits Overview Patient Range Mode amp Settings Alarm Limits Configuration SIMV AutoFlow PEEP 122 1 0 5 HOD vaves e Main vol FiO 35 Data Special Limin MY Procedure 4 5 s Limin MV spn bpm frota Js Vri 450 ui gt 65 Ext lll Int Freeze A gt System Setup x System Ventilation Patient Range y Adults or Pediatrics Overview Adults Pediatrics only Device starts without offering Patient the choice Range Adults or Pediatrics Mode amp Device offers on start up Settings the choice Alarm Limits Limin SIMV AutoFlow PEEP 12 10 58 e Main Yol FiO Data Special 35 MV Procedure 4 5 VS Limin MV spn 0 bpm Flota 3 Values GS Ext lil Int 139 16037547 16137547 Configuration Specific Initial Therapy Values Selecting a start up default for the ventilation mode O Press E System Setup key Touch Ventilation screen key e Touch Mode amp Settings screen key and enter access code 3032 EvitaXL first displays an overview of all configurable
174. n or decreased during expiration Airway pressure can be increased to not more than 5 cmH20 below the set upper alarm limit Paw and be reduced to not less than 0 cmH20 The maximum airway pressure is limited to Paw 5 cmH20 The advisory message Pressure limited is displayed Pressure support is calculated on the basis of a square function of tube resistance and patient flow APAW Comp KTube Flow APAW Pressure support on the tube Comp Degree of compensation 0 to 100 KTube Tube coefficient see table Flow Patient flow The tube coefficient KTube is largely determined on the basis of the results obtained by Gutmann Wolf et al see literature reference 19 on page 221 The tube coefficient KTube for the full length tube is always taken as the basis The effect of reduced length is negligible Tube type Inside tube Tube coefficient diameter mm KTube cmH20 L s Endotracheal tube 210 pa Sn Lb Xera suononasu 8unejedo Operating Instructions EvitaXL 1 US ed Tube type Inside tube Tube coefficient diameter mm KTube cmH20 L s Tracheotomy tube Theory of Operation Measurements 211 Theory of Operation Weaning Parameters Weaning Parameters P 0 1 RSB NIF A physician judging the ability of a patient to be weaned off the ventilator will consider a number of criteria Besides diagnostic and laboratory results ventilatory paramet
175. nce the sensor must be checked or calibrated with calibration gas Push CO sensor back onto the cuvette Checking CO calibration with calibration gas ifthe specified calibration value was not met when testing with the test filter atleast once every six months Switch EvitaxL on and wait for about 3 minutes for the CO2 sensor to complete its warm up First perform a CO2 zero calibration see page 120 then from the CO2 menu Touch Check sensor screen key 122 Freeze a Qe Sensor Parameter Flow 02 C02 Check with filter Compare filter value with displayed measured value Check with calibration gas Set cal gas concentration press Gas Check and compare displayed value with gas mixture Filter Check FCO vo Gas Check FCO2 Vol Calibration gas mixture 0 0 95 0 02 N20 Zero On Off Check sensor Calibration Pinean PEEP ES Vol FiO 35 Limin MV 4 5 Ves L min MV 0 bpm frota 10 L Vri 10 Values e Main Data Special Procedure 63 Ext Int 04637376 04737376 14137547 pa Sn L Xera suononasu 8unejedo Operating Instructions EvitaXL 1 US ed Connect calibration gas supply Use the cuvette from the calibration set 1 Connect calibration gas cylinder and cuvette of the calibration set to the hose 2 Remove CO2 sen
176. nd CAUTIONS as rendered throughout this manual and on labels on the equipment The design of the equipment the accompanying literature and the labeling on the equipment take into consideration that the purchase and use of the equipment are restricted to trained professionals and that certain inherent characteristics of the equipment are known to the trained operator Instructions warnings and caution statements are limited therefore largely to the specifics of the Draeger design This publication excludes references to various hazards which are obvious to a medical professional and operator of this equipment to the consequences of product misuse and to potentially adverse effects in patients with abnormal conditions Product modification or misuse can be dangerous Draeger Medical Inc disclaims all liability for the conse quences of product alterations or modifications as well as for the consequences which might result from the combination of this product with other products whether supplied by Draeger or by other manufacturers if such a combination is not endorsed by Draeger Medical Inc Patient monitoring The operators of the ventilator system must recognize their responsibility for choosing appropriate safety monitoring that supplies adequate information on equipment performance and patient condition Patient safety may be achieved through a wide variety of different means ranging from electronic surveillance of equipment perf
177. nd contacting the manufacturers distributors of third party humidifier devices about compliance of their products with the requested performance characteristics pa Sn L Xera suononasu 8unejedo Operating Instructions EvitaXL 1 US ed WARNING Do not place containers of liquids such as humidifier water reservoirs on top of or above the EvitaXL ventilator Liquids getting into the ventilator can cause equipment malfunction with the risk of patient injury WARNING Do not use a heat moisture exchanger simultaneously with a nebulizer or heated humidifier Risk of increased breathing resistance due to condensation WARNING To avoid any risk of electric shock in the event of faulty grounding of patient monitoring equipment do not use antistatic or electrically conductive patient circuits WARNING We strongly recommend using the electronic temperature monitoring feature of the ventilator if no proximal airway temperature monitoring is performed by the humidifier used WARNING To maintain grounding integrity connect only to a hospital grade receptacle Always disconnect supply before servicing WARNING Connecting other devices to the same extension power strip may cause the leakage current to the patient to increase beyond permissible values in the event of grounding failure In this case the risk of electric shock cannot be safely excluded WARNING Always use medical grade oxygen and air that
178. nejedo Operating Instructions EvitaXL 1 US ed Summary of WARNINGS and CAUTIONS General Precautions WARNING Strictly follow this Operator s Instruction Manual Any use of the product requires full understanding and strict observation of all portions of these instructions The equipment is only to be used for the purpose specified under Intended Medical Applications on page 20 and in conjunction with appropriate airway monitoring see page 23 Observe all WARNINGS and CAUTIONS as rendered throughout this manual and on labels on the equipment WARNING The EvitaXL ventilator must only be used under the super vision of qualified medical personnel in order to provide immediate corrective action in case of a malfunction WARNING Whenever a patient is connected to the ventilator constant attention by qualified medical staff is required in order to provide immediate corrective action in case of a malfunction WARNING This device is to be used only in rooms with line power installations complying with national safety standards for hospital patient rooms e g IEC 601 1 Safety of Medical Equipment To maintain grounding integrity connect only to a hospital grade receptacle Always disconnect supply before servicing WARNING DANGER risk of explosion if used in the presence of flammable gases or anesthetics This device is neither approved nor certified for use in areas where combustible or explo
179. neously thereby contributing a portion of the overall minute volume The difference between the sponta neously breathed minute volume and the set minute volume is provided by mandatory ventilator breaths Spontaneous breathing may be assisted by Pressure Support Set the pattern of ventilation for MMV and MMV PS with the ventilation parameters Tidal volume VT Inspiratory flow Flow Frequency f Inspiratory time Tinsp O2 concentration O2 Positive end expiratory pressure PEEP Pressure support PSupp Pressure rise time Slope Please refer to page 202 for a detailed description of MMV Operation MMV MMV PS Paw ASB pressure support Pmax configurable short long rise time rise time N trigger phase lt zija Flow ud MV 4 set MV spontaneously breathed MV mandatory MV t sufficient spontaneous breathing no spontaneous breathing beginning spontaneous breathing 71 01137547 01237547 Operation MMV MMV PS MMV Adult To set A Touch the respective screen knob Pos PEEP jo 5 ile Press dial knob to confirm setting i a 2 g S man 20 Vol FiOz 0 Data To view additional text information on 10 35 Special MMV MMV PS 50 Limin Flow A umn MV Procedure e Touch 4 key ouch Screen Key ae n E B 45
180. neously breathed minute volume MVspon Range Resolution Accuracy T10 90 BTPS Body Temperaturee Pressure Saturated lt 1 mL cmH20 lt 4 1 cmH20 L s lt 4 1 cmH20 L s lt 6 mL opens if medical air supply fails pressure lt 1 2 bar 17 4 psi enables spontaneous breathing with filtered ambient air opens the breathing system at 100 cmH20 Ppeak Pplat PEEP Pmean Pmin 0 to 99 cmH2O 1 cmH20 2 cmH20 15 to 100 Vol 1 Vol 96 3 Vol 96 0 to 99 L min BTPS 0 1 L min or for values less than 1 L min 0 01 L min 8 96 of measured value approx 35 s Measured values based on the conditions of the patient lung body temperature 37 C steam saturated gas ambient pressure 182 pa Sn Lb Xera suononasu 8unejedo Operating Instructions EvitaXL 1 US ed Tidal volume VTe Spontaneously breathed tidal volume VTspon Range Resolution Accuracy Tidal volume VTP Supp Inspiratory tidal volume during a pressure support breath Range Resolution Accuracy Frequency Measurement Breathing frequency ftot Spontaneous breathing frequency fspon Range Resolution Accuracy T10 90 Breathing gas temperature measurement Range Resolution Accuracy CO2 measurement in main flow optional End expiratory CO2 concentration etCO2 Range Resolution Accuracy for 0 to 40 mmHg for 0 to 100 mmHg T10 90 Warm up time 0 to 3999 mL BTPS 1 mL 8 of measured value 0 to 3999
181. ng To view additional text information on POV Assist Touch screen key PCV Assist can be supplemented to include the following ventilation mode extensions Flow trigger page 85 ATC page 89 These functions can be enabled via Add settings NOTE For setting alarm limits see page 96 Please refer to page 203 for a detailed description of PCV lt Assist 80 PAW Flow fast rise time without spontaneous breathing slow rise time Trigger window for synchronisation with spontaneous breathing PEEP go MH20 Paw Q Pmean n UT Freeze 5 40 5 ge Vol FiO 50 L min Flow E umn MV Lt 25 4D k 20 Limin MV spn 25 2 0 24 X bpm fita D APRY d 1 0 Basic L Vri settings 450 Tinsp M Slope settings m Pinsp PEEP Ai 12 M Values e Main Data Special Procedure 63 Ext Int 00937547 20937547 pa Sn L 1Xe3 suononasu 8unejedo Operating Instructions EvitaXL 1 US ed APRV B Airway Pressure Release Ventilation Free spontaneous breathing at a raised CPAP pressure level together with a short period of low pressure Release Set the pattern of ventilation for APRV with the ventilation parameters Inspiratory time Thigh Expiratory time Tlow Inspiratory pressure Phigh Positive end expiratory pressure Plow
182. nning on an external battery the internal battery is not recharged but rather trickle charged to prevent further discharge Operating times Operating times for the internal and external batteries depend on the charging condition and type of batteries connected see Technical Data page 191 AC DC Powered Operation Use of the Power Sources Charging Batteries Charging Batteries WARNING Leave the ventilator connected to AC power only in well ventilated areas In sufficient concentrations the hydrogen generated when charging batteries may otherwise lead to an explosion When AC supply is connected and the ventilator is switched on the internal batteries are charged first followed by the external batteries Integrated battery The integrated battery is only recharged when the ventilator is operating on AC power and the ventilator is switched on see Switching on on page 63 For recharging the internal battery it is sufficient for the ventilator to being operating in Standby mode NOTE Ensure that EvitaXL has been switched on Even if AC power is present the integrated battery will not be charged if EvitaXL is switched off The integrated battery is only fully charged after 24 hours NOTE EvitaXL must therefore be switched on and remain connected to AC power in Standby mode for at least 24 hours so that the integrated battery can be charged The unit switches over to trickle charge when the end
183. not to crease it Dispose of used cooling air filter with domestic waste Removing and reinserting the ambient air intake filter Clean or replace after 4 weeks Replace after 1 year at the latest If necessary swivel port to the left 3 Loosen screw with a coin and remove protective cover Replace protective cover and tighten screw with a coin e e e Dispose of used ambient air filter with domestic waste 160 O O Remove ambient air intake filter from the protective cover Slide the cleaned or new ambient air filter under the tabs 08937376 06137376 06237376 pa SN L Xera suononasu 8unejedo Operating Instructions EvitaXL 1 US ed Correct Disposal of Batteries and O2 Sensors WARNING Treatment of batteries and O2 sensor capsules Do not throw into fire Risk of explosion Do not force open Danger of bodily injury Follow all local state and federal regulations with respect to environmental protection when disposing of batteries and O2 sensor capsules For installation of a new O2 sensor capsule see Installing an O2 sensor capsule on page 36 Correct Disposal of the Ventilator atthe end of its useful life
184. nsation EvitaXL determines the difference between the delivered flow on the inspiratory side and the flow measured on the expiratory side This difference provides a measure of the amount of leakage and is displayed by EvitaXL as the leakage minute volume MVleak During volume controlled ventilation EvitaXL can compensate for this leakage Example Tidal volume setting VT 500 mL 10 tube leak Leakage compensation Off EvitaXL delivers 500 mL This is displayed as the inspiratory tidal volume VTi 50 mL escape as leakage during inspiration 450 mL reach the lung 450 mL are also expired of which 45 mL again escape as leakage A tidal volume of 405 mL is measured on the expiration side and indicated as VTe As a result an inspiratory minute volume of 5 0 L min will be delivered at a breath rate of 10 bpm and an expiratory minute volume of 4 05 L min will be measured The lung is ventilated with an MV of 4 5 L min Without leakage compensation the set VT directly determines the volume delivered by EvitaXL Leakage compensation On With automatic leakage compensation EvitaXL will deliver 550 mL on the basis of the measured leakage minute volume instead of the 500 mL set 500 mL enter the lung and the displayed inspiratory tidal volume VT is 500 mL The volume of 450 mL measured on the expiratory side is displayed without compensation even when leakage compensation is activated The minute volume measured on the expiratory s
185. ntilation may be continued Use external O2 monitoring and deactivate the integrated O2 monitoring Call DraegerService FiO2 low O2 sensor not calibrated Calibrate O2 sensor page 119 Faulty O2 blender Ventilator functions are not affected Ventilation may be continued Use external O2 monitoring and deactivate the integrated O2 monitoring Call DraegerService Flow measurement inop Water in flow sensor Dry flow sensor Flow sensor faulty Calibrate flow sensor see page 116 replace if necessary Flow measurement faulty Ventilator functions are not affected Ventilation may be continued Use external flow monitoring and deactivate the integrated flow monitoring Call DraegerService Flow monitoring off Flow monitoring is switched off Switch flow monitoring on again as described on page 126 or immediately ensure adequate external monitoring 167 Troubleshooting Message Cause Remedy Flow sensor Tm Flow sensor not fully inserted into the rubber lip of the expiratory valve Insert flow sensor correctly Hard key failed Dial knob can no longer be pressed Disconnect patient from the ventilator and continue ventilation immediately with another independent ventilator Use PEEP and or elevated O2 concentration as necessary Call DraegerService Hard key xx failed Key xx e g 100 O2 can no longer be pressed
186. ntilator for intensive care For adults children and infants with a body weight of at least 3 kg 6 6 Ibs May be used for ventilation of premature infants with NeoFlow option With the following ventilation modes CMV Continuous Mandatory Ventilation controlled and assisted constant volume ventilation with intermittent IPPV or continuous CPPV positive airway pressure With the options CPPV Continuous Positive Pressure Ventilation PLV Pressure Limited Ventilation AutoFlow for automatic control of Insp Flow and Pinsp IRV Inversed Ratio Ventilation SIMV Synchronized Intermittent Mandatory Ventilation Combines mechanical volume controlled ventilation with spontaneous breathing With the options PLV Pressure Limited Ventilation AutoFlow for automatic control of Insp Flow and Pinsp MMV Mandatory Minute Volume Ventilation spontaneous breathing with automatic adjustment of mandatory ventilation to the patient s minute volume requirement With the options PLV Pressure Limited Ventilation AutoFlow for automatic control of Insp Flow and Pinsp SB Spontaneous Breathing Spontaneous breathing at ambient pressure CPAP Continuous Positive Airway Pressure Spontaneous breathing with positive airway pressure 20 PSV Pressure Support Ventilation Pressure assisted spontaneous breathing PCV Pressure Controlled Ventilation plus BIPAP
187. number alarm text The meaning of the individual fields is as follows 01 Device failure 02 Air supply down 03 02 supply down 04 pressure meas inop 05 O2 measurement inop 06 flow measurement inop 07 mixer inop 08 exp valve inop 09 fan 1 defect 10 Temperaturee meas inop 12 Temperaturee high 13 flow sensor 14 PEEP high 195 Technical Data Data Protocols 70 ILV sync inop 71 MEDIBUS inop 73 ASB 1 5s 74 Leakage 75 neo flow monitoring off 76 neo flowsensor unsuitable 77 nebuliser off 78 PPS insp gt 1 5 s 79 PPS insp gt 4 s 80 ASB gt Tinsp 81 backup ventilation 82 Exsp hold interrupted 83 neo flow 84 apnea alarm off 85 MV low alarm off 86 VT high alarm off 87 Evita Remote error 88 Tube obstructed 89 Ext Flow compensated 90 Error multi functional board 91 Ambient pressure sensor 15 CO2 measurement inop 16 CO2 sensor 17 clean CO2 cuvette 18 CO2 zero 22 apnea 23 FiO2 high 24 FiO2 low 25 MV low 26 MV high 27 airway pressure low 28 airway pressure high 29 fail to cycle 30 high frequency 32 volume not constant 33 ASB gt 4s 34 etCO2 high 35 etCO2 low 36 air supply pr
188. of charge is reached External battery The external battery is only charged when the ventilator is being powered by AC power and the unit is switched on see Switching on on page 63 and the integrated battery has been fully charged For recharging the external battery it is sufficient for the ventilator to be operating in Standby mode NOTE Ensure that EvitaXL has been switched on Even if AC power is present the external battery will not be charged if EvitaXL is switched off The voltage of a connected external battery 12 V or 24 V is detected automatically by the DC power pack 55 AC DC Powered Operation Battery Maintenance Charging Batteries Charging Times The charging times specified under Technical Data apply when batteries are recharged immediately after a full discharge The charging time may be significantly longer if the batteries have discharged several times in succession without being fully recharged on AC power in the meantime The batteries must not be degraded in any way Charge indication and battery charge Charging of the integrated and external batteries is interrupted when the charging current drops to a very low value upon reaching the end of charge The battery is considered to be fully charged and this is indicated by a green battery symbol The battery capacity actually available at the end of the charging process depends among other things on the condition of the battery an
189. on Checking CO2 calibration with test filter Use test filter provided on the CO2 sensor cable Switch EvitaXL on and wait for about 3 minutes for the CO2 sensor to complete its warm up First perform CO zero calibration page 120 then from the CO2 menu Touch Check sensor screen key Touch Filter Check screen key Operation Sensors SIMV AutoFlow 60 emH20 displayed value with gas mixture Calibration gas mixture 0 0 95 0 O2 N20 40 A gr 20 0 10 Sensor Parameter x Flow 02 coz 1 Filter Check with filter Check Zero Compare filter value with payo displayed measured value FCO Vol Check sensor Calibration A a Gas Check with calibration gas Check Set cal gas concentration press gt Gas Check lt and compare FCOz vo Yol Limin Limin bpm igi gt 65 Ext 3i Int PEEP 125 100 Values 10 5 Main FiO Data 35 Special my Procedure 2m MVson 0 10 fitu 121 04537376 14137547 Operation Sensors Place test filter into the CO2 sensor EvitaXL now displays the test value of the CO concentration FCO2 in the menu Example FCO2 4 0 Vol This value must agree with the specification on the test filter within 0 3 Vol Example 4 1 Vol on the filter permitted value range 3 8 to 4 4 Vol If the test value is outside the permitted tolera
190. on Intrinsic PEEP Intrinsic PEEP Intrinsic PEEP is measured in two phases EvitaXL keeps the inspiratory and expiratory valves closed during measuring interval 1 so that it is impossible for gas to flow into the patient Paw circuit or to escape from it During this closed phase pressure is equalized between the lungs and the circuit system EvitaXL measures the pressure over time Measuring phase 1 is terminated PEEP insp and exp valves closed exp valve opens Intrinsic PEEP when no pressure changes are detected any longer at the earliest after 0 5 seconds Measuring Measuring atthe latest after 3 seconds in adult mode and 1 5 seconds Flow Hie Hie in pediatric mode respectively The start value corresponds to PEEP and the value at the end of the closed phase is the intrinsic PEEP Atthe end of measuring interval 1 EvitaXL opens the expiratory Vtrap valve and measures expiratory flow generated by intrinsic PEEP during a defined measuring interval 2 During this period lung pressure is allowed to decrease to PEEP level 02637547 Measuring interval 2 is terminated when the expiratory flow has returned to 0 but after 0 5 seconds at the earliest atthe latest after 7 seconds in adult mode or after 3 5 seconds in pediatric mode respectively 214 pa Sn i Xera suononsysu 8unejedo Operating Instructions EvitaXL 1 US ed The integr
191. on with positive pressure breaths Trigger assisted Continuous Mandatory Ventilation Continuous Positive Airway Pressure Breathing with continuous positive pressure in the airways Pressure supported breathing with continuous positive airway pressure Continuous Positive Pressure Ventilation Controlled ventilation with continuous positive airway pressure Electromagnetic compatibility End expiratory CO2 concentration Expiratory CO2 concentration breath rate frequency in bpm pa Sn Lb Xera suononasu 8unejedo Operating Instructions EvitaXL 1 US ed Abreviation fApnea FiO2 fmand fspn Fail to cycle FiO2 Flow Flowtrig IBW ID ILV int PEEP IPPV IPPVassist IRV ISO 5369 INE KTube Comp LUST MEDIBUS MMV MV MVleak MVspn NeoFlow NIF NIV NTC Definition Breath rate setting for apnea ventilation Inspiratory O2 concentration Mandatory mechanical portion of overall breath rate Spontaneous breathing portion of overall breath rate Breathing cycle failure Ventilator detects no inspiration Inspiratory O2 concentration Set value of the maximum inspiratory flow Set value of the flow trigger threshold Ideal body weight Internal tube diameter set value Independent Lung Ventilation Ventilation with 2 ventilators 1 for each lung Intermittent positive end expiratory pressure exp sigh Intermittent Positive Pressure Ventilation Trigger assisted Intermittent Pos
192. onnect Y piece with the rubber sleeve of the Y piece on the inspiratory side reusable silicone circuit 40 m vita xL Q O 000000 0 4m 07937547 pa Sn i Xera suononasu 8unejedo Operating Instructions EvitaXL 1 US ed Preparation Ventilating Adults and Children Installing a temperature sensor WARNING We strongly recommend using the electronic temperature monitoring feature of the ventilator if no proximal airway temperature monitoring is performed by the humidifier used 1 Push sensor as far as it will go into the rubber sleeve on the inspiratory side of the Y piece Align Y piece so that the sensor is at the top E 2 2 Attach sensor cable with hose clips gt 3 Insert plug of the temperature sensor into the socket at the rear of the unit i 010 C O e O 4 O C3 Sy Sus po O C WT Installing a CO2 cuvette and CO2 sensor available option CapnoPlus 4 Fit the cuvette to the patient connection of the Y piece with the cuvette windows facing the side 5 Push the CO2 sensor on to the cuvette with the cable
193. onnectors Ts 1 Clamp hinged circuit support arm to rail on the left hand side and tighten screws Evita x Connect ventilator circuit segments of appropriate lengths m lengths suggested are in meters 2 Install water trap s in vertical position Q D 000000 LT IL CHI y 1 ae 0 4m ses 0 6m 2 Providing Electrical Supplies and Connections AC line power supply The ventilator is designed for a line voltage of either 220 V to 240 V aN or 100 V to 127 V TO Insert plug into the power outlet the yellow LED will light up in the power source display on screen WARNING 3 O C3 To maintain grounding integrity connect only to a O 5 hospital grade receptacle Always disconnect supply before servicing ROS For operation with DC power unit and external battery sd available option either 12V or 24V 3 Connect the external battery with cable see Connecting an External Battery Optional on page 57 43 08337547 08437547 Preparation Gas Supply Precautions When Using a Power Strip for Auxiliary Equipment WARNING Connecting other devices to the same extension power strip m
194. or insufficient inspiratory gas is delivered during the set apnea delay time TApnea adjustable see Setting Alarm Limits page 96 EvitaXL will then start volume controlled ventilation with the set ventilation parameters Ventilator rate f Tidal volume VT The ventilation parameters O2 and PEEP will correspond to the settings effective at the time Inspiratory time for apnea ventilation is determined from the set apnea ventilator rate f and a fixed I E ratio of 1 2 As in SIMV the patient can breathe spontaneously during apnea ventilation and mandatory ventilator breaths will be synchronized with the patient s spontaneous breathing Apnea ventilator rate remains constant To set Touch Add settings screen key in the respective ventilation mode EvitaxL displays the possible supplemental settings Touch Apnea ventilation screen key EvitaxL displays the menu for setting apnea ventilation Touchthe screen knobs VT and f Turn dial knob to set press dial knob to confirm To activate deactivate apnea ventilation Touch On or Off screen key respectively then press dial knob to confirm EvitaxL displays the status of apnea ventilation on the main screen 86 PAW Spontaneous breathing with ASB pressure support Start of apnoea ventilation Flow apnoea alarm time TApnoea Fr 4 fApnoea emH20
195. or suction audible alarms are silenced in order to not disturb the suction routine After suction and reconnection EvitaXL ventilates in the set ventilation mode for 120 seconds as post oxygenation in adult patient mode with 100 Vol O2 in pediatric patient mode with an O2 concentration that is 25 higher than the set concentration During suction and for 2 minutes afterwards the lower alarm limit for minute volume is switched off Other alarms are switched off during suction and for15 seconds afterwards NOTE Pre post oxygenation is only possible with a functioning flow sensor and while flow monitoring is switched on Before suction Touch Special Procedure function key EvitaxL displays the menu Additional Function Touch O2 suction screen key the key turns yellow Press dial knob to confirm The key turns green and the oxygenation program is started 25 50 60 emH20 Limin Special Procedure Additional Diag Function nostics Inspiratory Hold Hold Exp Expiratory Hold Hold Insp Vol bpm Operation Special Functions Flota Ext Int 109 13437547 Operation Special Functions EvitaxL ventilates the patient in the set ventilation mode with increased O2 concentration 100 96 O2 by volume in adult mode and 25 96 higher O2 concentration than the set value in pediatric mode If PEEP
196. or switches the nebulizer off automatically after 30 minutes The flow sensor is automatically cleaned and calibrated after nebulizing Screen message Flow calibration Remove any leftover nebulizing solution Consult nebulizer Instructions for Use To view additional text information Touch screen key 108 Freeze Diag Additional Function nostics Inspiratory Hold ig Exp Expiratory Hold Hold touch and hold touch and hold Nebulizer Suction procedure der Ozt suction 40 Pu be 20 E E i3 0 10 50 Limin Flow acs gt 25 0 50 Special Procedure 4 x Press 10 Yol Limin L min bpm PEEP FiO2 Flota 10 63 Ext Int 13437547 pa Sn L Xera suononasu 8unejedo Operating Instructions EvitaXL 1 US ed Pre post oxygenation for bronchial suction To avoid any risk of hypoxia during bronchial suction EvitaxL offers programmed elevation of oxygen concentrations during the removal of secretions After starting the program EvitaxL ventilates in the set ventilation mode for 180 seconds as pre oxygenation in adult patient mode with 100 Vol O2 in pediatric patient mode with an O2 concentration that is 25 higher than the set concentration e g set value 60 Vol delivered 75 Vol When disconnection for suction occurs EvitaxL interrupts ventilation During the time f
197. ormance and patient condition to simple direct observation of clinical signs The responsibility for the selection of the best level of patient monitoring lies solely with the equipment operator Limitation of Liability Draeger Medical Inc s liability whether arising out of or related to manufacture and sale of the goods their installation demonstration sales representation use performance or otherwise including any liability based upon Draeger Medical Inc s Product Warranty is subject to and limited to the exclusive terms and conditions as set forth whether based upon breach of warranty or any other cause of action whatsoever regardless of any fault attributable to Draeger Medical Inc and regardless of the form of action including without limitation breach of warranty negligence strict liability or otherwise THE STATED EXPRESSED WARRANTIES ARE IN LIEU OF ALL OTHER WARRANTIES EXPRESSED OR IMPLIED INCLUDING WITHOUT LIMITATION WARRANTIES OF MERCHANTABILITY FITNESS FOR ANY PARTICULAR PURPOSE OR NONINFRINGEMENT Draeger Medical Inc shall not be liable for nor shall buyer be entitled to recover any special incidental or consequential damages or for any liability incurred by buyer to any third party in any way arising out of or relating to the goods pa Sn Lb Xera suononasu 8unejedo Operating Instructions EvitaXL 1 US ed Warranty All Draeger products are guaranteed to be free of defects for
198. p e Touch screen key PCV and PCV P Supp can be supplemented to include the following ventilation mode extensions Flow trigger page 85 Apnea ventilation page 86 ATC page 89 These functions can be enabled via Add settings NOTE For setting alarm limits see page 96 Operation PCV BIPAP PCV BIPAP P Supp 79 Operation PCV BIPAP Assist PCV BIPAP assist Pressure Controlled Ventilation Plus Assisted Pressure controlled assisted ventilation Delivered breaths are equivalent to those of PCV The switch from Pinsp to PEEP pressure is not however synchronized with patient expiration During the entire time of ventilation the patient may breathe spontaneously at PEEP pressure level Each detected spontaneous inspiratory patient effort will trigger a synchronized ventilator breath The ventilator will deliver an unsynchronized breath at the latest after the time defined by f has elapsed Set ventilation pattern for BIPAPAssist with the following parameters Inspiratory pressure Pinsp Ventilator rate f Inspiratory time Tinsp O2 concentration O2 Positive end expiratory pressure PEEP Pressure rise time Slope Flow trigger Flowtrig NOTE Inspiratory pressure Pinsp is set as an absolute value To set Touch the respective screen knob Turn dial knob to adjust setting Press dial knob to confirm setti
199. parameters Touch Modes screen key Four ventilation modes are displayed in the line Modes The screen key on the left marked Startup shows the mode in effect upon start of the ventilatorand is followed by three keys for other ventilation modes To select the initial ventilation mode Touch Startup screen key EvitaXL displays a list of possible ventilation modes O Select and confirm with the dial knob Other ventilation modes can be defined for the remaining three screen keys in the same way 140 P 60 cmHaO AWO 40 a Lt 20 0 10 System Setup x System Ventilation Configure modes for ventilation settings i overview Overview Startup Mode 2 Mode 3 Mode 4 Patient Modes SIMV CMY PCY CPAP Psupp Modes Range Mode amp IVT f Settings Alarm 02 LE m pressure timits Add settings Pmean PEEP ili od alues OMS O Main Vol 96 FiO2 Data 35 Special IUE my Procedure Ao L min MVspn bpm frota L Vri ADO Tar Ext Es Int 16237547 pa SN Lb Xera suononasu 8unejedo Operating Instructions EvitaXL 1 US ed Setting start up defaults for VT and f These are set in accordance with the patient mode adult or pediatric and patient weight O Press E System Setup key Touch Ventilation screen key e Touch Mode amp Settings screen key and enter access code 3032 Touch scree
200. ple SIMY J sou O d AC line power 2 O Ext External battery wu ccce ME PEEP ali a Freeze Ln sese O Int Integrated battery 40 my 10 5 ES e Main 20 vol FiO 0 Data A yellow LED lights up next to the 35 respective symbol to indicate the source m Limin Flow Umin MV Procedure from which the unit is being powered so TA A 45 Green LEDs next to the battery symbols Lmin MV indicate that the battery batteries is are d 0 50 fully charged NOTE Note the important information under Charge indication and battery sw charge on page 56 300 700 Vy bpm Flota L ne Vi A 450 o e i 2 65 Ext 100 E Apnea vent On 10 25 0 e o 58 O2 Vr Tins sp i PEEP Int 2427847 pa Sn Lb Xera suononasu 8unejedo Operating Instructions EvitaXL 1 US ed Operation with AC Line Power The ventilator switches to operation with AC power when connected to an AC power source The integrated battery is recharged during AC power operation The external battery is recharged once the integrated battery is fully charged The LED next to the plug symbol gt lights up yellow If the mains power supply fails the ventilator will automatically switches over to the external battery if available If an external battery is not available in the event of a power failure the ventilator switches over to the integrated battery and continues operat
201. pliance flow volume measurement is affected by the physical parameters such as temperature and humidity as well as by leaks in the circuit system EvitaXL takes these effects into account and corrects set and measured values accordingly Recalculating for standardized gas conditions The volume of a gas depends on the gas conditions temperature pressure and humidity For the purposes of lung physiology reference is made to the conditions inside the lung for values of minute ventilation and tidal volume 37 C body temperature pressure inside the lung 100 relative humidity Measured values for flow and volume under these conditions are characterized as BTPS Medical gases from cylinders or from a central supply on the other hand are dry approximately O relative humidity and are delivered from the ventilator at 20 C Flow and volume measurements under these conditions are characterized as NTPD The difference between values measured as NTPD or BTPS is typically around 12 96 BTPS Body Temperature Pressure Saturated NTPD Normal Temperature Pressure Dry Theory of Operation Measurements 207 Theory of Operation Measurements Example 500 mL tidal volume NTPD become 564 mL BTPS when warmed to 37 C and humidified to 100 relative humidity EvitaXL controls tidal volume in such a way that the set value of tidal volume is applied under BTPS conditions in the lung Automatic leakage compe
202. ponding option is in effect Display of waveforms loops trends Press EF System Setup key Touch Screen screen key EvitaxL displays the System Setup menu Touch Graphics screen key To select graph 1 2 or 3 Touch corresponding key in line Graphic 1 Graphic 2 or Graphic 3 The key turns yellow and the selection list is displayed Select and confirm the parameter with the dial knob Configuration Specific System Settings SIMV AutoFlow Pinean PEEP 123 rk 10 5 Wi vanes a e Main Vol 96 FiO Data 0 35 Special System Setup x umn my Procedure System Ventilation 4 5 15 1 dh p 60 Overview EA Mas Alarm Volume et Sound 0 Day Night Screen ppm Flota Day Night Night z Country 1 0 Interface L Vri Service 450 F H5 y gt 65 Ext A Int SIMV AutoFlow Prnean PEEP 123 Freeze 1 0 5 Mi vaues S el e Main Vol 96 FiO 35 Data Special System Setup x Umin MV Procedure System Ventilation 5 4 15 s Y 290 Configure default graphics displayed on main page EONA Limin MV spn Overview i Curve Curve Loop Trend Sound 0 Shorttrend Left Right erae Day Night Graphic 1 Paw Ppeak Paw Flow Paw Flow Paw Ppeak Sei bpm fotu E 7 Values Graphic 2 Flow MY Flow V low Paw MY P 1 0 a m s Trends Country Graphic 3 E Vte v Flow Paw V Flow f Einar Interface L Vri
203. psule see page 161 WARNING Treatment of batteries and O2 sensor capsules Do not throw into fire Risk of explosion Do not force open Danger of bodily injury Follow all local state and federal regulations with respect to environmental protection when disposing of batteries and O2 sensor capsules Precautions When Using Heat Moisture Exchangers The use of a heat moisture exchanger HME in the patient circuit can increase breathing resistance considerably An increase in breathing resistance will lead to increased work of spontaneous breathing and will require a greater trigger effort during assisted ventilation Under unfavorable conditions an increase in breathing resistance can also lead to intrinsic PEEP The operator must be aware that this breathing resistance in the patient circuit cannot be monitored by the ventilator Therefore you should regularly check the condition of the patient as well as the ventilator s measured values for volume and resistance WARNING Draeger cannot warrant or endorse the safe performance of heat moisture exchangers The user must verify that the heat moisture exchanger is covered by a technical safety certificate which guarantees complete suitability for the intended use Do not use a heat moisture exchanger simultaneously with a nebulizer or heated humidifier Risk of increased breathing resistance due to condensation Follow Instructions for Use of the heat moist
204. r 83 SpO2 sensor disinfecting x ios veiut odas 151 Standby 5i the iet delah ie hate RR etary het a 127 Start up settings for specific therapy suse 139 values Setting 0 2 0 eee 142 Sterilization eda adie ts are ln ea ius 152 Sterilizing oreste td ate Eg Sou aln AASE 150 SUCIO obits hss hte ides ate daa 109 Symbols fishes ss kt ed dales aibi 220 T Technical data ccc ee 180 Temperature sensor E A ib he ehe REPRE 151 removal aeinn 234 HAG aad dike eG gut dris 147 Theory of Operation 0 cece eee eee ees 198 Time CP wird ti fod eho had eae E 137 Trend 1 24 h display 105 configuration 2 6 eee 133 configuration of graphics 0 0008 131 display Thr uc att nod asec bbs Aere ga aed 102 Troubleshooting cee eee eee 164 Tube compensation c ccc 89 descriplion s nera deed Ric vem hha eres oe 209 Typing conventions cee eee 10 pa Sn L Xera suononasu 8unejedo Operating Instructions EvitaXL 1 US ed U UMDNS code zx stana orcas leas 187 Units selection of 137 V Ventilating adults A sienes Koea manera E e teta tor de egal 65 Ventilating infants SEWING cd dd edat ences i asas taion 65 Ventilation modes 2 nn 67 description iiie ace ta 198 setting start up default ooooocccoonoo 140 Ventilation parameters niew Setting currada atate teca Itc neut iu 65 Cruiip MER 31 A 130 Ww Warranty urna diarias lea
205. r breaths if FIO2 exceeds the upper alarm limit for at least 20 seconds if FiO2 falls below the lower alarm limit for at least 20 seconds both alarm limits are automatically linked to the set value for settings below 60 Vol threshold 4 Vol 60 Vol and above 6 Vol if the upper alarm limit has been exceeded 0 to 100 mmHg or O to 15 kPa if the lower alarm limit fell below 0 to 99 mmHg or O to 14 kPa 185 Technical Data Operating Data Functional oxygen saturation SpO2 optional Upper alarm limit alarm Setting range Lower alarm limit alarm Setting range Pulse optional Alarm at upper limit Setting range Alarm at lower limit Setting range Inspiratory breathing gas temperature Alarm at upper alarm limit Tachypnea monitoring Alarm Setting range Volume monitoring Lower alarm limit alarm Upper alarm limit alarm Setting range Apnea alarm delay time Alarm Setting range Operating Data AC power connection Current at 230 V at 100 V Power consumption 186 if the upper alarm limit has been exceeded 51 to 100 96 if the lower alarm limit has been undershot 50 to 99 96 if value has exceeded the upper alarm limit 21 to 250 bpm if value has fallen below lower alarm limit 20 to 249 bpm if temperature reaches 40 C EvitaXL may also be used without temperature sensor if the sensor is not connected on switching on WARNING We EACH recommend using the electronic temperature mon
206. ralloh coi tee ate e ete e t t eon 130 Control panel 26 Control unit Whats What emeim emen aa 174 Controls ventilation 3 5 tc A 27 GCooling alr ieiunii n e eins 17 Cooling air filter replaging essc iced eon peter ehe 160 D Date seting Oti e pb casa ed 137 DC Operation a ea dcha 54 DC power pack operation o 305 2 Sio aida ria pa a 54 technical data oooooooocccccrr ees 191 technical specifications oooooommmmmo m 191 DC socket 224229 44 pepe dd penes b4 57 DC DC converter eene 191 Definitions iii a RENNES 10 Detergents 0 0 0 ccc ccs 150 Disinfectants SUPACE idera trace n e i ed aes 150 Disinfecting tica ara dad n IA RUD Mb iS 150 Disposal of ventilator cli ede dex me ned 161 pa Sn L Xera suononasu 8unejedo Operating Instructions EvitaXL 1 US ed E Environmental conditions 0 eee eee ooo Environmental protection when disposing of batteries O2 sensors 17 Expiration manual uan ene Sunes x qur RA RR Rare Expiratory hold isset perpe aos Expiratory valve dismantling cece eee Explosion risk of 2 00 00 c cece 17 External flow compensation F Filter ambient air intake cooling ait css eer a nee gated Ge os Flow measurement description Flow sensor calibration ecrire e Re dee e en removal Flow trigger SOWING csi oet a oo FieG8ze suere OE Va E SA Ear ate pati dd Front connections layout G Gas SWITCHOVER alk
207. re Intrinsic Positive End Expiratory Pressure Set value of the upper pressure level APRV Set value of the upper pressure level in PCV Set value of the lower pressure level in PCV Set value for pressure limited ventilation Mean airway pressure Plethysmogram Pressure Limited Ventilation Peak pressure End inspiratory airway pressure Pressure Support Set value of Pressure Support Oxygenation program active Intraventricular excitation propagation in the ECG Resistance Acknowledge reset an alarm message Rapid Shallow Breathing Quotient of spontaneous breathing rate and tidal volume Spontaneous Breathing Spontaneous breathing at ambient pressure Synchronized Intermittent Mandatory Ventilation Pressure rise time for Pressure Support Functional oxygen saturation Inspiratory breathing gas temperature Apnea alarm delay time Expiration time pa Sn Lb Xera suononasu 8unejedo Operating Instructions EvitaXL 1 US ed Abreviation TGI Thigh Tinsp Tlow UMDNS V CO Vds VT VTApnea VTPsupp VTe Vri Vtrap Definition Tracheal Gas Insufflation Time for the upper pressure level in APRV Set value of the inspiratory time Time for the lower pressure level in APRV Universal Medical Device Nomenclature System Universal Medical Device Nomenclature CO2 production L min Serial dead space Setting for tidal volume Setting for tidal volume of apnea ventilation Inspiratory breathing volume
208. re shown without the exclamation marks indicating their alarm level NOTE If you wish to read these instructions without the ventilator in front of you you may keep the full page photograph folded out Preparing for use Positioning the control unit Preparing for use Always use properly prepared parts see Preparing page 131 Hospital infection control regulations must be observed Positioning the control unit The control unit must not be stood up or leant against anything nor may it be laid face downwards It must always be laid on its back when changing over Positioning on EvitaxL Hook the control unit into the mount on EvitaXL until it enade 77 C To adjust the position A 1 Press and hold the segments on the right and left at the O O same time tilting the control unit into the required position y 1 E i JAN ES Y y bob AA E Positioning on the wall rail 2 Press and hold the segments on the right and left tilting the control unit down completely at the same time T3 3 Press and hold the unlocking buttons on the right and left lifting the control unit out of the mount on EvitaXL at the same time Unwind the required length of cable Hook the control unit into the wall rail and 20 Instructions for Use Evitaxt WARNING Strictly follow this Operator s Instruction Manual Any use of the pro
209. rede or bee NO RE Eau a H HME Heat and Moisture Exchanger Humidifer type entering the Hygiene protocols sese l ILV SOING is tt e Een alee ati edat Insp O2 concentration when nebulizing InSpection coectetuer Ea Ea ERR RUE Inspiratory hold Intended use Interface configuring Intrinsic PEEP description SOWING Love aan K Keys fixed function SGFGGP a ees estre iain Salida iie ei ta Knobs screen Index L Labels Air intake CAUTION sess 177 Main WARNING CAUTION 00 177 Language selection of c ice ence sires oe gre 136 Leaktest eei e ERE pe Rer EP alee Rn 50 Leakage compensation description node Wek as We ii i m n elg s 208 Eogbook eir ehh hr Arbre br bte his 104 Loops configuration 6 eee eee 131 LUST protocol technical data 0 0 cece eee eee 192 M Maintenance 00 cece eee eee 155 158 Manual inspiration 1 0 0 eee 111 Mask ventilation ccc eee eee eee 93 Materials used 188 Measured values customizing display 0 c cece eee 135 defining initial defaults cc eee eee eee 132 display ii csi ecu vetet eae Oe ee 103 specifications sinaia iiaa aiar eee eee 182 MMV description acess si Vee ag eer eae ane tee Sk 202 setting sure ebd READ MR GG Send 71 Mobile telephones 0 0 ccc cece 11 22 Monitoring specifications SA asa pa eoa pebe
210. rential will cause an increased PCV ventilator breath As with CMV the time pattern is set using the basic setting parameters of ventilator rate f and inspiratory time Tinsp EvitaXL calculates the resulting inspiratory and expiratory times and displays them in the lower graphics screen field below the waveform display The lower pressure level is set with the PEEP parameter while the upper level is set with Pinsp When switching modes from SIMV to PCV only the Pinsp setting needs to be changed while maintaining the previous timing pattern The steepness of the increase from the lower pressure level to the upper pressure level is controlled by the rise time setting Slope The effective time for the increase in pressure cannot become greater than the set inspiratory time Tinsp This precaution ensures that the upper pressure level Pinsp is reached reliably during inspiration During weaning the transition from controlled ventilation to fully spontaneous breathing is achieved by gradually reducing inspiratory pressure Pinsp and or rate f PCV Assist BIPAPassist Pressure Controlled Ventilation Plus Assisted Pressure controlled assisted ventilation Used for all patients from those unable to breathe spontaneously to those breathing spontaneously before being weaned off the ventilator Inspiratory ventilator cycles are equivalent to those of PCV however the switch from Pinsp to PEEP is not synchronized with patient expiration
211. rfaces and analog interface optional Connection E for Remote Pad available option Connection A for nurse call available option Cooling air filter ILV socket for the connecting cable for independent lung ventilation with two Evita ventilators Connection for oxygen Connection for medical air Temp f socket for temperature sensor a 10 C02 socket for CO2 sensor optional 176 11 12 13 14 15 16 17 18 Sync socket for C Lock ECG synchronization for optional SpO2 measurement optional SpO2 f socket for functional SpO2 measurement available option COM1 RS232C socket for RS 232 interface e g for printer Rating plate not visible on the left hand side panel AC fuses Connector for power cord DC socket Fan 021237376 pa Sn L Xera suononasu 8unejedo Operating Instructions EvitaXL 1 US ed Labels Main WARNING CAUTION label Air intake CAUTION label Labels DANGER RISK OF EXPLOSION IF USED IN THE PRESENCE OF FLAMMABLE ANESTHETICS WARNING DISCONNECT SUPPLY BEFORE SERVICING REPAIRS ON THIS EQUIPMENT TO BE PERFORMED ONLY BY DraegerService OR ITS AUTHORIZED SERVICE CENTERS CAUTION TO MAINTAIN GROUNDING INTEGRITY CONNECT ONLY TO A HOSPITAL GRADE RECEPTACLE TO REDUCE RISK OF ELECTRIC SHOCK DO NOT REMOVE COVER USE ONLY DRY AND CLEAN COMPRESSED AIR AND OXYGEN WATER IN GA
212. rinsic PEEP measurement For determining intrinsic PEEP and measuring trapped volume Occlusion pressure measurement For evaluating a patient s breathing drive during spontaneous breathing Negative Inspiratory Force NIF For measuring the patient s maximum inspiratory effort following expiration Other features include DC power pack Internal DC power pack supplying EvitaXL with power from two DC sources viatwo 12 V lead acid gel batteries integrated into the internal DC power pack and optionally via additional external 12 V or 24 V lead acid gel batteries For uninterrupted operation following failure of the AC line power supply EvitaXL automatically switches to the external or internal battery For supplying power from the internal batteries or additionally from external batteries during transfer within the hospital Evita 4 Link optional Interface card For output of measured values status messages and alarm messages to on line equipment for monitoring documentation or processing Automatic gas switch over In the event of a gas failure EvitaXL automatically changes over to the other gas supply available Intended Use Intended Medical Applications 21 Intended Use Restrictions of Use Restrictions of Use CAUTION Restriction of Distribution Federal Law and Regulations in the United States and Canada restrict this device to sale by or on the order of a physician Device
213. rm limit Paw T in order to generate an alarm in the event of an increase in airway pressure with reduced compliance WARNING When using AutoFlow always set alarm limits MV and MV in order to avoid excessive or insuf ficient flow following rapid changes in compliance To set Touch Add settings screen key in the respective ventilation mode EvitaxL displays the possible supplemental settings Touch AutoFlow screen key To activate deactivate AutoFlow Touch On or Off screen key respectively then press dial knob to confirm EvitaxL displays the status of AutoFlow on the main screen 88 PAW Pinsp 7 f Vr C Flow Vr without spontaneous breathing with spontaneous breathing Y gt gt t 60 Pn H20 Paw Pmean PEEP 125 cene c ee 10 5 100 Values e Main Vol FiO 35 Data Special 2 Limin Flow Lmin MV Procedure Lt gt 4 5 x Y o20 Limin MV spn 25 a 0 Ventilator Settings 4 X bem fitu v EA es OPAPP Surry isa 1 0 E Apnea Flow Auto Pa Alcs ventilation trigger es Basic E Vu settings AutoFlow Sin eu x 450 s settings E n uj gt S Ext gt Int 01737547 19337547 pa Sn L Xera suononasu 8unejedo Operating Instructions EvitaXL 1 US ed ATC Automatic Tube Compensation Automatic compensation of the tube resistance
214. rosols 100 90 80 70 60 50 40 30 20 4 20 30 40 50 60 70 80 90 100 applied O2 concentration FiO2 Vol 96 set O2 concentration FiO2 Vol 96 02737547 215 Theory of Operation Abbreviations Abbreviations Abreviation Alarm Info APRV ASB ATC AutoFlow BIPAP PCV BIPAPassist PCV Assist body Wt bpm BTPS CAN CMV CMVassist CPAP CPAP Psupp CPPV EMC etCO2 FeCO2 216 Definition Display additional alarms Airway Pressure Release Ventilation Spontaneous breathing at continuous positive airway pressure with short term pressure release Assisted Spontaneous Breathing Pressure supported spontaneous breathing Automatic Tube Compensation Special function for automatic regulation of the inspiratory flow Biphasic Positive Airway Pressure Ventilation mode for spontaneous breathing at continuous positive airway pressure with two different pressure levels Biphasic Positive Airway Pressure Assisted Ventilation mode for assisted ventilation with continuous positive airway pressure with two different pressure levels Body weight kg breath per minute Body Temperatur Pressure Saturated Measured values based on the condition of the patient s lungs with body temperature 37 C water vapor saturated gas atmospheric pressure Compliance Controller Area Network Continuous Mandatory Ventilation Mandatory ventilati
215. rotocol consists of 4 different transmission telegrams Identification telegram Status telegram Data telegram Alarm telegram The first three telegrams are only sent in response to a request from the external unit The alarm telegram is sent automatically when an alarm occurs or disappears Telegram control The following ASCII control characters are used to request the individual telegrams ACK Request for an identification telegram NAK Request for a status telegram ENQ Request for a data telegram Output of all telegrams can be controlled via certain control characters DC1 xon Enables telegram output DC3 xoff Halts output at any time Following an enable DC1 the interrupted telegram is resent without being adjusted to the actual status Requesting a telegram overrides the effect of DC3 the telegram interrupted by DC1 is lost and the requested telegram is sent Output of an alarm telegram can also be controlled DC2 Enables output of the alarm telegrams DC4 Halts the output of alarm telegrams Ongoing transmissions are not interrupted by DC4 This is only possible with DC3 x off A telegram request ACK ENQ or NAK does not act to re enable the output of alarm telegrams Following a DC2 the last event is transmitted by the alarms in each case If no alarm events have occurred an alarm telegram with all active alarms is requested with each DC2 Unknown contro
216. rs via a trigger time window with a fixed time constant The duration of the trigger window is 5 seconds in adult patient mode and 1 5 seconds in pediatric mode respectively If the expiratory time is less than 5 seconds or 1 5 seconds in pediatric mode the trigger window covers the entire expiratory time At the Pinsp pressure level the trigger window is 1 4 x Tinsp seconds long Recent clinical research has shown this smooth adaptation to the patient s spontaneous breathing to require less sedation allowing the patient to return to spontaneous breathing more rapidly References 3 4 7 11 12 page 221 Reference 8 page 221 Theory of Operation Ventilation Modes 203 Theory of Operation Ventilation Modes As in all pressure controlled ventilation modes the patient is not locked into a fixed tidal volume VT The tidal volume basically results from the pressure difference between settings for PEEP and Pinsp Changes in lung compliance and airways as well as the patient s active breathing against the ventilator can lead to changes in tidal volume This is a desired effect in this ventilation mode Knowing that tidal volume and therefore minute volume are not constant the alarm limits for minute volume must be carefully adjusted The display of measured expiratory tidal volume VTe must be used to set the required difference between the two pressure levels Any increase in the pressure diffe
217. rted when alarms occur Failure to identify and correct alarm situations may result in patient injury 130 Freeze ta Lt System Setup System Ventilation Alarm volume Day Night Graphics Values Trends Function keys Lock Customized table Language Units Date Time COMI COM2 COMS Analog Overview Sound Day Night Screen pi Country Interface Service SIMV AutoFlow Pmean PEEP LES Yol FiO 35 L min MV 4 5 bt L min MV 0 bpm fitu 10 23 100 Values e Main Data Special Procedure 63 Ext Int Freeze A Qe System Setup x System Ventilation D Ovai Alarm Volume 60 eatin Sound Day Night Screen Day Night Night Country Interface Service SIMV AutoFlow Press TORES Yol FiO 39 Limin MY 4 5 UAE L min MV 0 bpm fiot 10 3 Vri Uim 100 Values e Main Data Special Procedure 63 Ext Int 14737547 14837547 pa SN L Xera suononasu Burrejed y Operating Instructions EvitaXL 1 US ed Day night function for screen bright ness Press EF System Setup key Touch Sound Day Night screen key Two options are available Day for a strong contrast and bright colors and Night for reduced screen brightness Touch Day or Night screen key the selected key turns green and the corres
218. s 12 3 I D Values e Main Data Special Procedure 63 Ext Int 19637547 20037547 pa Sn L Xera suononasu 8unejedo Operating Instructions EvitaXL 1 US ed Monitoring in Mask mode WARNING Only switch off alarms if the safety of the patient will not be compromised by the absence of an alarm The operator of the ventilator system must still assume full responsibility for proper ventilation and patient safety in all situations The following alarms may be deactivated in order to avoid artifacts MV lower alarm limit minute volume Vri upper alarm limit inspiratory tidal volume TApnea upper alarm limit apnea monitoring For activating deactivating alarms see Setting Alarm Limits on page 96 An advisory message is constantly displayed in the alarm field if an alarm limit has been deactivated EvitaXL automatically selects the configured default alarm limits when changing over to Tube application mode A time lag TDisconnect between O and 60 seconds can be set for the alarm limit PAW airway pressure low The following alarms are not displayed by EvitaxL in Mask mode PS gt 4s PS 1 5s PS Tinsp Leakage WARNING Always check and restore alarm limits and ventilator set tings after changing from Mask to Tube mode in order to ensure comprehensive ventilation monitoring Leak compensation in Mask
219. s made can be monitored see Displaying 1 hr trends on page 102 25 50 60 emH20 Limin Paw Flow A gi Special Procedure Additional Diag Function nostics P0 1 Start P0 1 Time Date 2 4 cmH20 11 18 10 08 2001 P0 1 Time Date 2 2 cmH20 10 30 10 08 2001 Operation Diagnostic Functions Pmean PEEP 123 10 5 10 Values e Main Yol FiO Data D z nm Mv CER Abs s Y 20 Limin MV spr bpm totai L Vr 450 y gt Ext 3l Int 113 13537547 Operation Diagnostic Functions Intrinsic PEEP PEEPi Intrinsic PEEP is the actual end expira tory pressure in the lung Due to the dynamics of lung mechanics resistance compliance and closing volume and the set parameters of ventilation intrinsic PEEP differs from PEEP in the upper airways The Intrinsic PEEP measuring maneuver also measures the trapped volume resulting from this difference in PEEP values i e the amount of air trapped in the lungs and therefore not taking part in the process of gas exchange This special procedure can be performed in all ventilation modes NOTE Patient activity during this maneuver can distort the values measured Touch Special Procedure function key EvitaxL displays the Additional Function menu Touch Diagnostics screen key e Touch PEEPi screen key EvitaXL displays the last measured value
220. s 9 Waveforms configuration iii e edad 131 Weaning parameters description uae eere nt 212 What s What ossis e eee eee 174 Index 229 230 This page intentionally left blank pa Sn Lb Xera suononasu 8unejedo This page intentionally left blank pa SN L Xer suononuisu Bunesado 231 These Instructions for Use apply only to EvitaXL with Serial No If no Serial No has been filled in by Draeger these Instructions for Use are provided for general information only and are not intended for use with any specific machine or device Manufactured by Distributed by Dr ger Medical AG amp Co KGaA Draeger Medical Inc Germany 1 3136 Quarry Road Moislinger Allee 53 55 Telford PA 18969 D 23542 L beck U S A f 49 4518 82 0 f 215 721 5400 T 26 80 70 800 4DRAGER 800 437 2437 FAX 49 451 8 82 20 80 FAX 215 723 5935 http www draeger com 90 37 547 GA 5664 590 en us O Dr ger Medical AG amp Co KGaA 1st edition September 2002 Subject to modifications
221. s required by hospital protocol see Configuration on page 135 Display all measured values and settings EvitaxL displays all measured values and settings in two tables for facilitating documentation Values and settings for listing according to a specific hospital protocol may be compiled in a third table see Configuration on page 135 Touch Data screen key EvitaxL displays the Data menu with its Values submenu The table of hospital specific values and settings is displayed as the default and the screen key Custom Table is white To select table 1 or table 2 Touch Table 1 or Table 2 screen key respectively Touch x screen key to close the table Operation Displaying Measured Values SIMV AutoFlow USE Paw pe BEN 40 a gt 20 ER E EA 0 10 go min Flow g gt 25 h D 25 y 50 V 700 E A gt 500 300 100 0 0 2 4 6 Apnea vent On 10 25 o 8 10 12 14 16 Pmean PEEP 10 5 emH20 Pres 2M finang fon 10 0 bpm fitu 10 L VTP supp 0 L Vri 123 OW Values e Main Data Special Procedure z7 d 65 Ext E Oz f BEER Psupp lij Int SIMV AutoFlow Pmean PEEP 123 Freeze 1 0 5 Mii vaues ES el e Main Vol 96 FiO 35 Special Data x lmin my Procedure Values Logbook Trends 4 5 15 E Y 20 Measured values Custom Lmin MV spn Table MY 4
222. selected here are saved as a trend Touch screen key of the first measured value to be selected The key turns yellow and the selection list is displayed Select and confirm with the dial knob Configuration Specific System Settings SIMV AutoFlow Press Custom Data Lock Service Freeze 1 A DE Vol 96 System Setup 7 seem Ventilation Configure 8 measured values to be stored as trends a Mes Overview Overview Trends 1 4 Mv Ppeak T VTe sua Graphics Day Night Trends 5 8 VTP Supp RSBi P0 1 PEEPi UTEM vum Values p Trends Country Function Interface L Keys DOS 35 4 5 vis MVeon 0 Flota 10 Vri Data Special Procedure 65 Ext Int 133 15237547 Configuration Specific System Settings Defining function keys Seven additional on screen function keys can be defined for accessing a function directly instead of going through a menu O Press 1 System Setup key Touch Screen screen key Touch Function Keys screen key EvitaXL now displays the menu for defining seven additional function keys Touch the new key to be defined it turns yellow A selection list is displayed beside the keys Select and confirm with the dial knob 134 go cmH20 Paw Freeze 40 A fd 20 D 10 System Setup x System Ventilation Configure the additional 4 Over
223. sive gas mixtures are likely Important Safety Information Summary of WARNINGS and CAUTIONS WARNING Never use flammable medications e g on the basis of ethanol or other substances based on flammable sol vents in the patient circuit Fire hazard Always provide adequate ventilation when using flammable substances for disinfection WARNING Do not use mobile phones within 33 feet 10 m of the ventilator Mobile phones can cause interference with electrical and electronic medical equipment with the risk of patient injury WARNING Do not use in conjunction with magnetic resonance imaging MRI Equipment malfunction with the risk of patient injury may result WARNING Using high frequency electrosurgery equipment defibril lators or short wave treatment equipment in the vicinity of the ventilator may interfere with its operation and pose a risk of patient injury WARNING Do not use the EvitaXL ventilator in hyperbaric chambers Equipment malfunction may result with the risk of patient injury WARNING Do not place the EvitaXL ventilator on a patient s bed while in motion Ensure that the ventilator is properly secured to prevent it from falling or being knocked over 11 Important Safety Information Summary of WARNINGS and CAUTIONS WARNING When using EvitaXL in combination with other products and when using EvitaXL during patient transfers the per son responsible for operat
224. sor from its park bracket and place onto the cuvette from the calibration set 3 Read the CO2 O2 and N20 concentrations Vol 96 of the calibration gas from test cylinder Calibration gas e g 5 Vol CO2 95 Vol N2 Enter these concentration values with the on screen parameter setting knobs Touch respective screen knob Turn dial knob to enter concentration If the calibration gas consists only of CO2 and N2 set O2 and N20 concentrations to O Touch Gas Check screen key EvitaxL displays the CO2 concentration FCO2 in the menu Example FCO2 5 0 Vol After about 10 seconds the value of FCO2 must match the CO2 content of the calibration gas within 0 2 Vol If the calibration value is outside the permitted tolerance the CO2 sensor must be recalibrated with calibration gas Push CO sensor back onto the cuvette Operation Sensors LL displayed value with gas mixture gp Pn H20 Paw Pmean PEEP 122 A A AA ANNAN Freese 1 0 5 WW Values e Main 20 vol Fio 0 Data 10 Special y Procedure Sensor Parameter X Umin MV Flow O2 eos 4 5 15 y Y 20 Filter Check with filter Check Zero Limin MV spn Compare filter value with Pauci displayed measured value FCO2 vo Check 0 sensor Calibration PPM Fiota A A Gas Check with calibration gas Check 1 0 Set cal gas
225. sors are saved until the next calibration run even when the ventilator was switched off in the meantime After the test procedure Perform a leak test see page 50 Preparation Checks of Readiness for Operation 49 Preparation Leak Test Leak Test Perform this test after the tests of readiness for operation after changing the patient circuit after changing the humidifier In the checklist Touch Airtight Check screen key The result of the last leak test is displayed together with the following values Leakage Compliance Insp resistance Exp resistance To start the leak test Touch Check screen key The actual leakage flow is displayed continuously throughout the test A leakage flow of 300 mL min at a pressure of 60 cmH20 is acceptable After the leak test the ventilator determines the compliance and the inspiratory and expiratory resistance of the patient circuit EvitaXL uses the calculated patient circuit compliance to automatically correct both volume controlled ventilator breaths as well as values measured as part of flow monitoring see page 207 NOTE When changing the patient mode or type of humidifier the ventilator automatically resets the values for circuit compliance and resistance to the default values To return to the start screen Touch Start Standby screen key in the Start Standby menu 50 Evita XL S
226. ssfully tested to be ready for ope ration WARNING In case of a fault in any of the built in monitoring a substi tute has to be provided in order to maintain an adequate level of monitoring The operator of the ventilator must still assume full responsibility for proper ventilation and patient safety in all situations WARNING If a fault is detected in the ventilator and its life support functions are in doubt ventilation must be started without delay with an independent ventilation device resuscita tion bag using PEEP and or increased inspiratory O2 concentration where necessary and appropriate The unit should then be removed from use and serviced by an authorized service technician WARNING e Always use extreme caution when using oxygen Oxygen intensely supports any burning No smoking no open fire in areas where oxygen is in use e Always provide adequate ventilation in order to maintain ambient O2 concentrations lt 24 96 Always secure O2 cylinders against tipping do not expose to extreme heat Donotuse oil or grease on O2 equipment such as tank valves or pressure regulators Do not touch with oily hands Risk of fire Open and close valves slowly with smooth turns Do not use any tools WARNING Always heed all precautions and follow all hospital protocols with respect to the administration of oxygen Make adjustments to the FiO2 according to the blood gas values measured pa
227. ssible Operation Sensors S MV Adult AutoFlow Da Freeze A Ph Sensor Parameter x Flow 02 C02 Calibration COz sensor Start Zero On Off Sensor calibration only if necessary Set calibration gas mixture press gt Start lt 0 0 Follow device instruction manual Resetting CO calibration pe Reset calibration data press gt Reset Cal lt and confirm Check sensor Calibration Pan PEEP 423 1 0 5 HOD vares e Main WOES FiO 35 Data Special Limin MV Procedure 5 15 A Y 20 Lmin MV ipn 0 bpm Flota 63 Ext Int SIMV AutoFlow Press 3 FEED 10 5 Wi vaes e el e Main Vol FiO Data m 35 Special Procedure Sensor Parameter X lumin my Procedure Flow 02 CO2 4 5 15 uude c Calibration COz sensor Start Zero Limin MV spn On Off Sensor calibration only if necessary Set calibration gas mixture press Start 0 0 Follow device instruction manual Resetting CO calibration E Reset calibration data press Reset Cal and confirm Check sensor Calibration 0 bpm Flota 63 Ext Int 125 14037547 14037547 Operation Switching off Monitoring Functions Switching off Monitoring Functions e g if a spent sensor cannot be replaced immediately WARNING In case of a fault in any of the built in monitoring a substitute has to be provided in order to mainta
228. t Patient Patient Mask Application we NIV Start Standby Tube Attention Mask The mask ventilation mode NIV for Humid non invasive ventilation may not be ifier used on intubated patients Check alarm limits after change ake from mask ventilation NIV to tube mode Tube compensation ATC On Standby Pmean PEEP Yol FiO Limin MV 4s Y 290 Umin MV spn bpm frota L Vii cae li Mii Values e Main Data Special Procedure 63 Ext Int 51 19837547 52 This page intentionally left blank pa Sn Lb Xera suononasu 8unejedo Operating Instructions EvitaXL 1 US ed Power Sources Overview 0 ccc ccc ehh ans 54 Use of the Power Sources oooooocccccccccnccn eee eee 55 Charging Batteries 3 ems aue sam dc ode ese e ea abr e a de ne 55 Battery Maintenance x ivctccd ddd diee bcd vs bre da ui ob pa 56 Connecting an External Battery Optional oooooocccoccccccccccc o 57 Power Source displays licua eos Pad ca a ar er ee dal 58 Operation with AC Line Power sseee n 59 Operation with Integrated Battery ocoocccccccccocccccrn eee 59 Operation with External Battery Available Option oooococccccoo 60 53 AC DC Powered Operation Power Sources Overview AC DC Powered Operation EvitaXL contains a DC power pack with integrated battery to ensure that operation of the ventilator can continue for at least 10 minutes following
229. t Settings f bpm Modeext vr LE Screen P i Values Patient Flow Slope E 1 0 E Trends Country ATC state Tinsp Pinsp mm Interface L Vri Keys Tube ID Custom Service 45 0 15 Data M US Lock zT I5 65 Ext lil Int 135 15437547 15537547 Configuration Specific System Settings Locking direct access to settings This function is used to prevent parameter settings from being changed directly through the row of screen knobs Thev can still be adjusted using the M Ventilator Settings key Press i System Setup key Touch Screen screen key Touch Lock screen key Touch g screen key The symbol appears at the bottom of the main screen in the row of screen knobs To deactivate the lock touch d screen key Selecting the display language The following languages may be selected German Italian English Swedish US English Dutch French Russian Spanish Chinese Portuguese The ventilator is factory configured to the language at the customer site To select a different language O Press System Setup key Touch FJ Country the screen key The current language is displayed in the Language field Touch W screen key EvitaxL displays a selection list Select and confirm new language with the dial knob 136 System Setup system Ventilation Direct access to settings V
230. t of the menu are initial default values They are in effect when the ventilator is switched on and when a new ventilation mode is selected New Patient Evita XL Start Operation Setting New Ventilation Parameters SIMV AutoFlow Start Standby New Previous Patient Patient Ventilation begins with the pre configured start up settings Ventilation sar BEC Patient k Ped SIMY AutoFlow vr 450 L 5 cmH20 ATC Off Tinsp abs set 36 Vol Application tube f 10 bpm 6 cmH20 lz S Ext ii Int Start Standb Ideal Body Weight Sony x Weight Evita XL Start SIMV AutoFlow Start Standby New Previous Patient Patient Ventilation begins with the pre configured start up settings Ventilation SS EEC Patient k Ped SIMY AutoFlow vr 450 L ATC Off Tinsp 1 7 sec Application tube f 10 bpm Start Standby Ideal Body Weight S Weight 5 cmH20 36 Vol 6 cmH20 y 2 65 Ext li Int 65 19937547 10437547 Operation Setting New Ventilation Parameters Start ventilation Touch Start screen key press dial knob to confirm The ventilator starts with these initial values Check settings To set ventilation parameters Press v Ventilator Settings key Touch respective ventilation parameters in the Ventilator Settings menu turn dial knob to set press dial knob to confirm Arrows
231. ta Special go min Flow a umin my Procedure pe i A 4 5 15 0 E Y 20 L min MVspn 25 E 0 Ventilator Settings 24 X bpm fita PCV CPAPIPs uy APRY moi l oo Bii 10 A Apnea Flow Auto cuero ATO ventilation trigger Flow Basic L Vr settings c B w is 1 450 settings a vie ig Ext Comp Dg cell Int Paw 4 PTrachea 19437547 01637547 pa Sn L Xera suononysuj 8unejedo Operating Instructions EvitaXL 1 US ed Sigh Atelectasis can be prevented by activating the Sigh function and setting sigh breaths in the form of an intermittent PEEP When the Sigh function is activated end expiratory pressure increases by the set value of intermittent PEEP for two ventilator breaths every 3 minutes Sigh is set with the parameter intermittent PEEP int PEEP To set Touch Add settings screen key in the respective ventilation mode EvitaxL displays the possible supplemental settings Touch Sigh screen key EvitaxL displays the menu for setting the Sigh function Touch int PEEP screen knob turn dial knob to set value press dial knob to confirm To activate deactivate the Sigh function Touch On or Off screen key respectively then press dial knob to confirm Please refer to page 200 for a detailed description of the Sigh function Operation Sigh PAW Sigh p
232. taXL 118 0 mH20 Paw Freeze 40 Pu pb 20 0 10 Sensor Parameter x Flow O2 CO2 Calibration Sun Manual calibration required After exchanging flow sensor Monitoring EN Off When switching the monitor to Off it must be replaced by external monitoring External Flow Compensation En zi measure External Flow O Limin Time 14 01 Date 23 08 2001 Press 10 Vol 96 FiO 35 Limin MV 4 5 vis Limin MVspn 0 bpm Flota 10 PEEP 12 il Values 5 Mit e Main Data Special Procedure 63 Ext Int 13837547 pa Sn Lb Xera suononasu 8unejedo Operating Instructions EvitaXL 1 US ed O2 sensor calibration after replacing the O2 sensor wait 15 minutes for the O2 sensor to warm up when measured and set values diverge by more than 2 Vol The O2 sensor may be calibrated during ventilation e Press S Sensor Parameter key Touch O2 screen key EvitaXL displays the menu for O2 Start O2 calibration Touch Start screen key The key turns green and EvitaXL now calibrates the O2 sensor Sensor Parameter Display on screen Flow 02 CO2 O2 calibration active The Start screen key turns pale green Calibration S when calibration is complete Peg REALE After exchanging O2 sensor If measured and set values deviate more than 2 96 by volume Monitoring off When switching the moni
233. tandby Start Standby New Current Patient Patient Airtight Check Leakage 20 mL min acceptable 300 mL min 10 mL cmHzO 0 5 cmH2O L s 0 8 cmHzO L s Compliance insp Resistance exp Resistance Overview Device Check Airtight Check Stat Standby Tube Mask Humid ifier Check Standby Pmean PEEP Yol FiO L min MV 45 Y 290 L min MV bpm fitu E Vri ls w b 123 100 Values e Main Data Special Procedure 63 Ext Int Evita XL Standby Start Standby New Current Patient Patient Ventilation begins with the current settings Ventilation mar Patient SIMY AutoFlow vr 450 L ATC Off Tinsp 17 sec Application tube f 10 bpm Ideal Body Weight Weight PEEP 5 cmH20 02 36 Vol Psupp 6 cmH20 Start Standby Tube Mask Humid ifier Check Yol Limin Limin bpm fitu Mi Values e Main Data Special Procedure 63 Ext Int 04037547 10337547 pa SN L 1Xe1 3 suononujsu Bueaedo Operating Instructions EvitaXL 1 US ed Entering the Humidifer Type In standby mode Touch the screen key Humidifier EvitaXL displays the menu for entering the humidifier type used LZ Active Humid heated breathing gas humidifier oli HME Filter heat and moisture exchanger Touch screen key corresponding to the type of humidifier used The key will turn ye
234. the alarm limit is exceeded three times EvitaxL generates a warning Tidal volume is actively limited to the value of the alarm limit VTi f by switching to PEEP level expiration when necessary WARNING When using AutoFlow always set alarm limits MV and MV in order to avoid excessive or insufficient flow following rapid changes in compliance Theory of Operation Ventilation Modes PAW Pinsp f Vr C PEEP Tinsp Flow VT t without spontaneous breathing with spontaneous breathing 199 01737547 Theory of Operation Ventilation Modes An inspiratory time Tinsp set to a value shorter than the time required to fill the lungs can be recognized in the flow waveform the flow at the end of inspiration has not fallen to zero In this situation it must be decided whether the current patient condition permits extending inspiratory time in order to reduce peak pressure even further This effect can also develop in the course of ventilation e g due to a buildup of secretions In this situation pressure is limited by the alarm limit Paw T The pressure rise is held to 5 cmH20 below the alarm limit Paw f The Volume not constant alarm will only become active when the set tidal volume VT is no longer fully applied The start of a mandatory inspiration can be synchronized with a patient s own efforts using the adjustable flow trigger Only whi
235. thed MV t no spontaneous beginning spontaneous sufficient spontaneous breathing breathing breathing 01237547 Experience shows patients breathe very irregularly Phases of shallow breathing alternate with phases of tachypnea and large respiratory effort In order to allow for these individual fluctuations the balancing process also takes into account the extent to which the set minimum ventilation has been exceeded Within a maximum of 7 5 seconds after an apnea EvitaXL progressively reduces this value to zero In this way the response time of EvitaXL is automatically adapted to the preceding cycles of spontaneous breathing before activating mandatory ventilation If this spontaneous breathing was close to the minimum ventilation the machine responds rapidly within the cycle time 1 f However if the patient s spontaneous breathing was much higher than the set minimum ventilation EvitaXL will tolerate a longer breathing pause In extreme cases of sudden apnea after a phase of deep breathing the response time will be 7 5 seconds plus the trigger time with a minimum of 1 IMV cycle time 202 pa Sn i Xera suononasu 8unejedo Operating Instructions EvitaXL 1 US ed Response times longer than 15 seconds may only occur if the minimum ventilation with a low IMV frequency f is set to correspondingly low values In this case EvitaXL will trigger an apnea alarm that will disappear again after the start of
236. three exclamation marks and appear against a red background Example Tidal volume high EvitaXL generates a 5 tone sequence that is sounded twice and repeated every 7 seconds Caution medium priority message Cautions are identified by two exclamation marks and appear against a yellow background Example O2 supply pressure high EvitaXL generates a 3 tone sequence which is repeated every 20 seconds Advisory low priority message Advisory messages are identified by one exclamation mark and appear against a yellow background Example Fan malfunction EvitaXL generates a 2 tone sequence which is sounded only once Remedy the fault refer to the troubleshooting list on page 164 LL Aa Apnea vent On 10 25 s Qo o 25 50 700 500 300 100 0 p Operation In the Event of an Alarm Pmean PEEP 107755 Vol Fio 35 Limin MY 4D Limin MV spr 0 bpm Flota 10 Mi Values e Main Data Special Procedure Ext Int 97 21037547 Operation In the Event of an Alarm The alarm tone ceases automatically when the fault has been remedied Cautions and advisory messages disappear automatically Warnings appear in the color of the status line and must be acknowledged Touch Alarm Reset screen key The message is deleted from the screen However it is saved in the ventilator and can be displaye
237. tinue ventilation immediately with another independent ventilator Use PEEP and or elevated O2 concentration as necessary Call DraegerService Check frequency ILV Slave Message on slave device during ILV The breathing rate of the master and slave devices differ by more than 12 96 Adjust the rate of the slave ventilator to that of the master Check settings n Power interruption while setting a ventilation pattern or alarm limits Check ventilatoion pattern and alarm limits Confirm message with Alarm Reset key Clean CO2 cuvette Window of cuvette for CO2 measurement is dirty Use clean cuvette Sensor window for CO2 measurement is dirty Clean CO sensor 165 Troubleshooting Message Cause Remedy CO2 measurement inop Tm CO2 sensor faulty Replace faulty CO2 sensor CO2 measurement incorrect Ventilator functions are not affected Ensure adequate external monitoring without delay Deactivate integrated CO2 monitoring Call DraegerService CO2 monitoring off CO2 monitoring is switched off Switch CO2 monitoring on again see page 126 or ensure adequate external monitoring without delay CO2 sensor m CO2 sensor was disconnected during operation Reinsert connector CO sensor for CO2 measurement not properly positioned on cuvette Place CO2 sensor on cuvette CO2 sensor for CO2 measurement faulty Replac
238. to a fully charged external battery within 10 minutes Internal battery only 2 minutes left The ventilator is being powered by its integrated DC battery due to the absence of AC line power or an external battery The remaining time for operation with power from the integrated battery is 2 minutes Connect ventilator to AC line power or to a fully charged external battery within 2 minutes 168 pa Sn L Xera suononasu 8unejedo Operating Instructions EvitaXL 1 US ed Troubleshooting Message Cause Remedy Key overused Dial knob pressed too often within a short space of time Acknowledge message with Alarm Reset key If the message reoccurs frequently disconnect patient from the ventilator and continue ventilation immediately with another independent ventilator Use PEEP and or elevated O2 concentration as necessary Call DraegerService Key overused Due to very frequent key use the screen contents of the display are repeatedly redrawn Confirm message with key Alarm Reset Brief communication failure between the display processor and main processor Confirm message with key Alarm Reset Disconnect patient from the ventilator and continue ventilation immediately with another independent ventilator Use PEEP and or elevated O2 concentration as necessary Call DraegerService Key xx overused Key has been pressed several times in a short p
239. tor to Off it must be replaced by external monitoring Operation Sensors Pmean PEEP 12 10 58 e Main Vol FiO Data Special 35 MV Procedure 4 5 DS 3 Values Limin Umin MV spn 0 bpm frota 10 iL Vr z i 65 Ext alll Int CO2 sensor calibration optional CO sensors are factory calibrated and may be used without further calibration on any EvitaxL ventilator EvitaXL performs a zero calibration as part of the ventilator check procedure A full calibration of the CO2 sensor is only required if the specified test values are not met when checking the calibration with a test filter or with test gas The calibration check or calibration may be performed during ventilation 119 13937547 Operation Sensors CO2 zero calibration ifthe ventilator requests a CO2 zero calibration with the screen message CO2 zero calibration ifthe CO2 waveform no longer returns to zero during each inspiration before each calibration test see page 121 or page 122 before each CO calibration page 124 Switch EvitaxL on Wait about 3 minutes for the complete warm up of the CO2 sensor After about 3 minutes measured values will be within their specified range of accuracy e Press S Sensor Parameter key Touch CO2 screen key EvitaXL displays the menu for CO2 Start zero calibration Touch Start screen key
240. tration Accuracy Positive end expiratory pressure PEEP or intermittent PEEP Trigger sensitivity Pressure assist Pressure Support Rise time for pressure assist Independent lung ventilation ILV Master Slave BTPS Body Temperaturee Pressure Saturated 10 to 40 C 700 to 1060 hPa 5 to 90 96 20 to 60 C 4 to 140 F 500 to 1060 hPa 5 to 95 96 0 to 100 bpm 0 1to 10s 0 02 to 0 3 L BTPS greater of 10 96 of set value or 10 mL 0 1 to 2 0 L BTPS greater of 10 96 of set value or 25 mL 6 to 30 L min 6 to 120 L min 0 to 80 cmH20 0 to 100 cmH20 21 to 100 Vol greater of 5 of set value or 2 Vol 0 to 35 cmH20 0 3 to 15 L min O to 80 cmH20 Oto2s with trigger without trigger synchr asynchr inverse E Measured values relating to the conditions of the patient lung body temperature 37 C water vapor saturated gas ambient pressure 180 pa SN Lb Xera suononasu 8unejedo Operating Instructions EvitaXL 1 US ed ATC Automatic Tube Compensation Adult mode Inside tube diameter ID Range Resolution Degree of compensation Comp Range Resolution Pediatric mode Inside tube diameter ID Range Resolution Degree of compensation Comp Range Resolution Performance Data Control principle Intermittent PEEP frequency Nebulizing of pharmaceutical aerosols Bronchial suction Disconnection detection Reconnection detection Pre oxygenation Active suct
241. ure PEEP To set Touch the respective screen knob Turn dial knob to adjust setting Press dial knob to confirm setting ILV Master can be supplemented to include the following ventilation mode extensions Flow trigger page 85 Automatic Tube Compensation ATC page 89 Sigh page 91 Pressure Limited Ventilation PLV page 92 These functions can be enabled via Add settings 74 Paw Insp pause eds XL configu PEEP rable Tinsp Te Flow NM Y 1 f Insp flow t 35 Flow 4 L min MV A 4 5 y y Umin p MV Ventilator Settings m A FI 1 555 o o 22 X bpm fita a SPRY yore 10 Basic L Vri settings 450 settings E ve s e iz Flow PEEP ilr Special Procedure 6 Ext Int 00537547 18337547 pa Sn L Xera suononasu 8unejedo Operating Instructions EvitaXL 1 US ed Setting ILV Slave Volume controlled ventilation with fixed mandatory minute volume MV set with tidal volume VT and ventilator rate f by the ILV Master device and Slave mode selected For independent lung ventilation of patients with no spontaneous breathing To set Slave mode Touch Extra settings screen key Touch Slave Mode screen key Select desired slave mode e g Asynchron Touch the resp
242. ure exchanger HME When using a heat and moisture exchanger Set ventilator to HME see page 51 Preparation Precautions When Using Heat Moisture Exchangers 37 Preparation Potential Hazards from Use of Expiratory Bacteria Filters Potential Hazards from Use of Expiratory Bacteria Filters The use of an expiratory bacteria filter is not mandatory Use of bacteria filters in the expiratory side of the patient circuit can cause an undesirable increase in breathing resistance Particularly when nebulizing aerosols or humidifying the breathing gas resistance caused by a bacteria filter may slowly increase leading to increased work of breathing and to intrinsic PEEP WARNING The flow resistance of bacteria filters placed in the expiratory side may be substantially increased by nebulized aerosols with the risk of impaired ventilation If an expiratory filter is used during nebulization airway pressures and flow should be monitored for any indication of increased expiratory resistance due to filter obstruction Intrinsic PEEP may be recognized by the fact that expiratory flow has not returned to O at the end of expiration In case of unacceptably high PEEP the ventilator will issue the alarm message PEEP high Check bacteria filter and exchange if it proves to be the cause of high PEEP 38 pa Sn Lb Xera suononasu 8unejedo Operating Instructions EvitaXL 1 US ed Installing a Heated
243. utes of operation Internal battery only 2 minutes left The ventilator must be reconnected to AC power within 2 minutes or lt must be connected to a fully charged external battery The warning Internal battery discharged is displayed after 10 minutes of operation The power supply must be restored immediately either from an AC source or from a fully charged external battery otherwise ventilation will be interrupted After using power from the integrated battery Recharge integrated and external batteries as soon as possible see Charging Batteries on page 55 59 AC DC Powered Operation Operation with External Battery Available Option Operation with External Battery Available Option Connect external battery If the AC power supply fails EvitaxL immediately switches over to a connected external battery The LED next to the symbol for external battery lights up yellow The green LED next to the symbol for external battery goes out as it is no longer fully charged NOTE The changeover to external battery power is performed without any alarm message The time available for operation from an external battery depends on the battery charge and the type of battery connected If the external battery is exhausted EvitaXL automatically switches over to the integrated battery and generates an alarm NOTE When AC power is restored EvitaXL automatically switches back to operation wit
244. via Add settings To view additional text information on ILV Touch screen key 60 emH20 Freeze ta gt 20 e 0 Flow CPAPIPS UP NN APRY ua 50 Limin m Qt E B A 0 25 l i j 50 22 X e e e Flow o PEEP Basic settings Operation ILV Pmean PEEP 123 5 100 Values e Main Vol 96 FiO Data Do an MV Procedure 4 5 s Limin MV spr 0 bpm Flota Limin 10 it Vr 450 iT D 3i s 77 18537547 Operation PCV BIPAP PCV BIPAP P Supp PCV BIPAP PCV BIPAP P Supp Pressure Controlled Ventilation Plus Pressure Support Pressure controlled ventilation combined with free spontaneous breathing at any time during the breathing cycle and adjustable pressure support at CPAP level The mandatory portion of the total minute volume MV is set with inspiratory pressure Pinsp and breath rate f In the course of the weaning process the ventilator rate may be reduced to O The ventilator will then automatically switch to CPAP or CPAP P Supp ventilation mode and it will also indicate this new ventilation mode on screen NOTE The PCV screen key and the screen knobs for PCV BIPAP ventilation parameters will continue to be displayed Set the pattern of ventilation for PCV BIPAP and PCV BIPAP P Supp with the ventilation parameters Inspiratory pressure Pinsp
245. view function keys Overview y Sound Graphics Day Night Screen Values p Trends County Function Interface Keys Custom Service Data Lock Limin SIMV AutoFlow Yol FiO Data Special 35 MV Pasaia 4 5 a Limin MV ipn 0 bpm Flota 10 k Vri A450 iy D d FIM SpO 2 sensor go cmH20 Paw Freeze 40 Lt 20 0 10 System Setup x System Ventilation eres the additional Overview nction Keys Nebulizer Overview O2 suction Sound Insp hold Graphics Day Night Exp hold P0 1 Screen PEEP Values NIF p Day Night Trends Country Print Logbook Monte Function M Values keys Diagnostics Custom Service Ventilation Data Flow sensor NeoFlow sensor Lock O2 sensor CO2 sensor SIMV AutoFlow po PEEP Ji vaues 10 5 e Main Vol 96 FiO2 35 Data Special umin my Procedure 4 5 s L min MVspn bpm fita S Ext 3i Int 15337547 18237547 pa SN 1 TXeHAW suononujsu Bureaedo Operating Instructions EvitaXL 1 US ed Defining customized tables of values and settings O Press E System Setup key Touch Screen screen key e Touch Custom Data screen key e Touch Measured Values screen key EvitaXL first displays the menu for compiling the customized table of measured values Up to
246. vitaXL 1 US ed Operating Instructions EvitaXL 1 US ed Working with these Operating Instructions Header line the title of the main chapter Titles of the respective sub sections are printed below the main header to help you find your way quickly from subject to subject Page body the Operating Instructions combine text and illustrations The information is presented as sequential steps of action giving the user hands on experience in learning how to use the ventilator Left hand column the text provides explanations and instructs the operator step by step in the practical use of the product with short clear instructions in easy to follow sequence Bullet points indicate separate actions Where several actions are described numbers are used both to refer to the relevant details in the illustrations and to specify the sequence of actions Right hand column the illustrations provide visual reference for the text and for locating the various parts of the equipment Elements mentioned in the text are highlighted Unnecessary details are omitted Rendering of screen displays guide the user and allow to reconfirm actions performed Typing conventions Controls are designated as Control Name e g PEEP Screen pages are indicated as Screen pagex e g Measured values Screen messages are printed in bold e g Flow Calibration Screen messages rendered throughout the text a
247. witching off that the former patient mode is no longer available 64 SIMV AutoFlow Evita XL Start Start Standby New Previous Patient Patient Ventilation begins with the previous settings Start A Standby Ideal Body Weight Ventilation Sr SHE 1 C75 Patient LEESUES x Peod Weight SIMV AutoFlow vr 450 L PEEP 5 cmH20 ATC Off Tinsp 17 sec O2 36 Vol96 Application tube f 10 bpm Psupp 6 cmH20 lar D 63 Ext il Int 21137547 pa SN L TXeHAW suononajsu BuiyesodO Operating Instructions EvitaXL 1 US ed Setting New Ventilation Parameters With EvitaxL the patient mode may be selected in two alternative ways Select amp Adult or amp Ped Setan ideal body weight Both alternatives can be configured see Configuration page 139 EvitaxL is configured at the factory for selection of an ideal body weight NOTE The remaining description of the procedure is based on this configuration Depending on the required patient mode touch one of the screen keys O either amp Adult or amp Ped Touch the screen knob Ideal Body Weight Turn dial knob to enter the ideal body weight kg press dial knob to confirm EvitaxL determines the tidal volume VT and ventilation frequency f on the basis of the ideal body weight and displays these values in the lower part of the menu The other ventilation parameters displayed in the lower par
248. x gt 100 1 min x L were not yet ready to be weaned EvitaXL indicates the RSB index in CPAP and in Pressure Support modes Negative Inspiratory Force NIF The Negative Inspiratory Force Index NIF measures a patient s maximum inhalation effort after exhaling The patient system is closed during measurement of NIF This value is also known as the Maximum Inspiratory Pressure MIP As a result of the inhalation effort during manually extended expiration the patient generates a negative pressure in relation to PEEP The probability that the patient can be weaned successfully increases with the magnitude of this negative pressure Patients reaching a NIF lt 30 cmH20 can in all probability be weaned successfully while those with a NIF of less than 20 cmH20 will most likely prove unsuccessful EvitaXL determines the value of NIF during manually extended expiration The patient system closes following an expiration by the patient while the Exp hold key is held down and EvitaxL measures the maximum inhalation effort made by the patient The NIF is measured as a pressure relative to PEEP The measuring procedure is ended when the Exp hold key is released or after a maximum of 15 seconds The last measured NIF value and the time of measurement are shown on screen in Table 2 of measured values Reference 16 page 221 References 17 18 page 221 Theory of Operation Weaning Parameters 213 Theory of Operati
249. xternal voltages to the analog interface outputs of the Evita 4 Link interface card 13 Important Safety Information Summary of WARNINGS and CAUTIONS Precautions regarding electrical supplies WARNING Only use rechargeable batteries Explosion hazard Single use batteries may explode when being charged with the DC power pack while ventilator is operating on line power WARNING Only external batteries may be connected to the DC socket of the ventilator and only using the connecting cable specified in the Ordering Information WARNING Do not connect any AC powered equipment to the external battery connection socket of the ventilator WARNING Leave the ventilator connected to AC power only in well ventilated areas In sufficient concentrations the hydrogen generated when charging batteries may otherwise lead to an explosion WARNING It is mandatory and responsibility of the user to ensure sufficient battery capacity See Battery Maintenance CAUTION The capacity of batteries must be checked regularly and the batteries replaced if necessary Avoid deep discharges they lead to premature wear CAUTION Avoid storing the ventilator for extended periods at temperatures over 50 C The internal battery and O2 sensors may be damaged or equipment life may be shortened 14 Precautions during operation WARNING Always use ventilator that has been cleaned and disinfec ted and has been succe
250. y injury Follow all local state and federal regulations with respect to environmental protection when disposing of batteries and O2 sensor capsules WARNING Both breathing and cooling air are drawn in through the filter cover Do not block air intake do not place ventilator immedi ately against a wall risk of overheating the ventilator WARNING When servicing the ventilator always use replacement parts that are qualified to Draeger standards Draeger cannot warrant or endorse the safe performance of third party replacement parts for use with the EvitaXL ventilator CAUTION Maintenance This device must be inspected and serviced at regular intervals A record must be kept on this preventive maintenance We recommend obtaining a service contract with DraegerService through your vendor For repairs we recommend that you contact DraegerService 17 18 This page intentionally left blank pa Sn Lb Xera suononasu 8unejedo Operating Instructions EvitaXL 1 US ed Intended Medical Applications sssssssseeeeee A 20 Intended Areas of Use o oooccccccccoc hans 21 Restrictions of Use iii dace a a da GR UG cen ie 22 Appropriate Monitoring arse tiares tiiiga iis RII n 23 19 Intended Use Intended Medical Applications Intended Use NOTE These Operating Instructions apply also to Evita 4 when equipped with the XL option Intended Medical Applications EvitaXL Long term ve

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