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Evita 2 dura

1-25

1-96

Intensive Care Ventilator
Instructions for Use
Software 4.n

1-25

1-96

Содержание Evita 2 Dura

Страница 1: ...Evita 2 dura 1 251 96 Intensive Care Ventilator Instructions for Use Software 4 n 1 251 96 ...

Страница 2: ...rence for the text and make it easier to locate the various parts of the equipment Elements mentioned in the text are highlighted Unnecessary details are avoided Screen displays prompt the user to proceed and conﬁrm correct actions Preparing for use 18 Fitting components Preparing for use The following instructions cover Assembly of the various equipment items Electrical connection and gas connect...

Страница 3: ... Tube blocked Additional weaning parameters available as software version 4 n plus upgrade in addition to the parameter occlusion pressure P 0 1 Evita 2 dura 4 n also determines the parameters RSB Rapid Shallow Breathing index and NIF Negative Inspiratory Force Index fspn and MVspn as trend External ﬂow source available as software version 4 n plus upgrade The amount of external flow is calculated...

Страница 4: ...4 ...

Страница 5: ...d that of Your Patients 6 Intended Medical Application 8 Operating Concept 9 Preparing 17 Operation 37 Configuration 71 Fault Cause Remedy 83 Care 89 What s what 101 Technical Data 107 Description 115 Parts List 132 Order List 134 Index 136 ...

Страница 6: ...ioning such parts e g disinfectant residues left behind after autoclaving may corrode the material Such parts must be replaced immediately if external signs of wear become evident such as cracks deformation discoloration peeling etc Not for use in areas of explosion hazard This apparatus is neither approved nor certiﬁed for use in areas where combustible or explosive gas mixtures are likely to occ...

Страница 7: ...e vicinity of the mobile telephone and therefore lead to faults and malfunctions When the unit is mounted onto the trolley it must NOT be tilted at more than 5o this could cause the entire assembly to tip over Appropriate ventilation monitoring The built in monitoring facilities of the Evita 2 dura ventilator ensure appropriate monitoring of ventilation therapy and therefore will detect any undesi...

Страница 8: ...ventilation combined with free spontaneous breathing during the complete breathing cycle and adjustable pressure increase to CPAP level Registered trade mark BIPAPAssist Biphasic Positive Airway Pressure Assisted Pressure controlled assisted ventilation APRV Airway Pressure Release Ventilation optional Spontaneous breathing on two pressure levels with long time ranges independently adjustable Spec...

Страница 9: ...Operating Controls 11 Keys for routine and additional functions 11 Power switch 12 Standby key O 12 Screen Pages 13 Structure of the main page 13 Structure of the application specific pages 13 Screen page Settings 14 Screen page Alarms 14 Screen page Measurements 14 Screen page Calibration Configuration 15 Colour screen 16 Operating Concept ...

Страница 10: ...e parameters To set turn the rotary knob To confirm setting press the rotary knob Setting ventilation parameters 2 To set a ventilation parameter press the corresponding parameter key The yellow LED in the key lights up 3 To set the value of the ventilation parameter turn the rotary knob The value is displayed next to the parameter key 3 To confirm the value press the rotary knob The yellow LED go...

Страница 11: ...ine and additional functions 4 Frequently used keys for routine functions are positioned on the right hand side of the front panel g key for suppressing the audible alarm tone Alarm Reset key for resetting or acknowledging alarm messages key for calling up information and help on the desired setting key for protecting against inadvertent or unauthorised modiﬁcation of the settings of the ventilati...

Страница 12: ...t the switch from being switched off inadvertently Standby key O Placed on its own away from other keys For keeping the apparatus on standby or for switching on ventilation To switch to standby Press and hold down the O key for at least 3 seconds To switch on ventilation Briefly press and release the O key 004 083 005 D Evita 2 dura ...

Страница 13: ... page Line for the active ventilation mode patient mode and trigger indicator Bar for alarm warning and advisory messages Field for menu selection keys Field for measured values Field for curves Bar for information and help Structure of the application speciﬁc pages Bar for the currently active ventilation mode and patient mode example BIPAP Field for displaying the selected menu Field for the men...

Страница 14: ...ing intermittent PEEP sigh For detailed operating instructions see Setting ventilation modes on page 41 onwards Screen page Alarms For displaying the measured values with their alarm limits For setting the alarm limits For detailed operating instructions see Setting alarm limits on page 53 Screen page Measured values For displaying all the measured values in the current ventilation mode Press the ...

Страница 15: ... off Device Setting the volume of the acoustic alarm Setting the screen contrast Setting the date and time Selecting language and measurement units Setting the external interfaces Display Selecting 2 x 6 measured values from the main page Selecting 2 x 2 curves from the main page Ventilation Patient mode Ventilation mode Ventilation parameters Alarm limits ...

Страница 16: ...Yellow Caution or advisory message Blue Alarm is no longer active Example Apnoea alarm For menu buttons Green Can be selected Black Has been selected Example Menu button Device For screen keys Green LED in the screen key function not active Yellow LED in the screen key function active Example Screen key Flow function active 503 504 505 ...

Страница 17: ... Fitting bacterial filter 23 Fitting humidifier and ventilation hoses 23 In house intra hospital transport 24 If no instrument tray option is fitted to the device 24 Supply and Connections 25 Electrical power supply 25 Note on the use of a socket strip 25 Temporary interruption of power supply 25 Gas supply 26 Evita Remote 27 Connection 27 Note automatic self test 28 Nurse call optional 29 Device ...

Страница 18: ...repared parts see Care page 90 Fitting the expiration valve Push the expiration valve block firmly into the mounting Check that it is properly secured by gently pulling the port Fitting the ﬂow sensor 1 Push the socket to the left as far as it will go 2 Insert the flow sensor with the probe facing towards the ventilator into the mounting and push it into the socket as far as it will go Then 3 Push...

Страница 19: ...e protective cover 3 Unscrew the two knurled screws and open the sensor housing 4 Insert new sensor The sensor end with the visible circular tracks on the contacts goes into the housing 3 Close the sensor housing securely with the two knurled screws Screw the protective cover back in place After inserting Wait 15 minutes for the O2 sensor to warm up The O2 sensor cannot be calibrated until it has ...

Страница 20: ...exchanger HME Do not use the heat and moisture exchanger HME at the same time as a medicament nebuliser or humidifier Note on the use of bacterial ﬁlters The use of expiratory bacterial ﬁlters and or HME ﬁlters on the ventilator is not recommended However if bacterial ﬁlters are nevertheless used on the expiration side an undesirable increase in breathing resistance is possible Especially during m...

Страница 21: ...ark with distilled water Connection of ventilation hoses Do not use antistatic or conductive hoses Depending on the desired position of the ventilator in relation to the bed the hinged arm can be ﬁtted to either side of the machine Attachment on left hand side 4 Turn both ports to the left 5 Turn Aquapor to the left The following description applies when the ventilation hoses have been attached on...

Страница 22: ...ubber sleeve of the Y piece on the inspiratory side Fitting the temperature sensor option 4 Push the sensor as far as it will go into the rubber sleeve on the inspiratory side of the Y piece Align the Y piece so that the sensor is on top 5 Attach the sensor cable with hose clips 6 Insert the probe of the temperature sensor into the socket Temp at the rear of the unit Do not place any containers wi...

Страница 23: ...the Fisher Paykel MR 730 humidifier in accordance with the separate Instructions for Use using hose set K paediatric as supplied 1 Hang the humidifier with a bracket to the mounting below the machine and tighten the screws 2 Hang the hinged arm with a bracket to the rail on the left hand side and tighten the screws Connect the ventilation hoses and note their length in metres 3 Place the water tra...

Страница 24: ...olley Humidifier secured to the trolley not to the ceiling pendant bed wall If no instrument tray option is ﬁtted to the device Seal off the slits in the top panel with the rubber plugs 1 Press the round plugs in the front slits rounded part facing outwards 2 Press the flat plugs into the rear slits Do not place any liquid container e g infusion container above or on top of the Evita 2 dura Any le...

Страница 25: ...he same extension socket strip may in the event of earth failure cause the current leakage to the patient to increase beyond the permissible values In this case the risk of electric shock cannot be eliminated Temporary interruption of power supply e g when switching on the reserve power supply Without optional Evita DC power supply During the power failure Evita 2 dura will output a continuous ton...

Страница 26: ...imit With optional Evita DC power supply Follow Instructions for Use of the Evita DC power supply Gas supply Screw the connecting hoses for medical air and oxygen to the back panel of Evita 2 dura and insert their probes into the terminal units The compressed gases must be dry and free from dust and oil Gas pressure must be 3 to 6 bar Other equipment e g printers may only be connected to the COM p...

Страница 27: ... Neb key to start and end medicament nebulisation 6 O2 Y Suction key for bronchial suctioning 7 Insp hold key for sustained manually induced inspiration 8 Exp hold key for extended and sustained expiration The function of the respective LEDs and keys is the same as that of the corresponding elements on the front panel of Evita 2 dura and is described in the application chapters of the Instructions...

Страница 28: ... Pad to Evita 2 dura while the latter is switched on or when switching on Evita 2 dura after connecting the Remote Pad Do not press any keys on the Remote Pad All LEDs on the Remote Pad light up for 5 seconds Red LED Yellow LED Yellow LEDs in the keys The Remote Pad is tested by Evita 2 dura An advisory message is output if a fault is detected see page 84 Fault Cause Remedy 069 ...

Страница 29: ...central alarm typically use only one channel The electronics for nurse call consequently also uses only one channel Technical Data Floating DC contact Input voltage Max 40 V Input current Max 500 mA Switching capacity Max 15 W The central hospital alarm system may only be connected to the nurse call if Evita 2 dura is connected to the mains power supply via a mains power cable or if it has been ea...

Страница 30: ...tem The test results obtained from this device check and the calibration and zero checking values of the sensors remain stored until the next calibration even if the device is switched off If the hose system type of humidiﬁcation or patient mode is changed after performing the device check the leakprooﬁng test must be repeated before starting operation Preparing the adult test lung 84 03 201 for t...

Страница 31: ...h on the machine raise flap and press power switch on the back panel until it clicks into position Evita 2 dura runs through its self test procedure Wait until the 10 second test phase has been completed After the self test 1 Switch Evita 2 dura to standby Hold down key O for about 3 seconds 2 Switch off the standby alarm tone with the Alarm Reset key Touch the Device check menu key The standby al...

Страница 32: ...elected type of humidiﬁer is indicated by a black dot in the corresponding screen key If the type of humidiﬁer is changed and has to be reselected on the screen the following test steps are shown to be invalid after the device check Humidification Air tight check The operator is prompted to repeat the device check for these two steps Start Device check Press the Check jj menu key and select the me...

Страница 33: ...installed CO2 sensor if CapnoPlus option is installed Calibration of the neonate flow sensor if NeoFlow option is installed The user is guided through each check in a dialogue with the device Questions are displayed in the information line and must be answered by entering Yes or No Instructions for carrying out the check may also be displayed instead On completion of the Device check a checklist i...

Страница 34: ...g the patient mode or type of humidiﬁer and when cancelling the leak test the ventilator automatically resets the values for patient circuit compliance and patient circuit resistance to the default values The Tightness test is shown to be invalid and the operator is prompted to repeat the test Select the menu Tightness via the menu button Check jj Activate screen key Start press rotary knob The Ti...

Страница 35: ...se when the device check and leak test have been successfully completed Either Leave Evita in Standby mode and if necessary preselect the ventilation mode and ventilation parameters or 1 Immediately start up Evita 2 dura press O or 2 Switch off Evita 2 dura for later use Switch on back panel pivot the cover flap to the side press button in as far as it will go and release 079 D Evita 2 dura 1 080 ...

Страница 36: ...36 ...

Страница 37: ...Caution medium priority message 54 Advisory low priority message 54 Suppressing the audible alarm 55 Information J 55 Displaying Curves and Measured Values 56 In the main page 56 Display measured values 57 Curve freezing 58 Special Functions 59 Manual inspiration 59 Manual expiration hold 59 Medicament nebulisation 60 Oxygen enrichment for bronchial suction 63 Selecting Standby Mode 65 Switching t...

Страница 38: ...st inadvertent switching off To switch the ventilator off first pivot the mains power switch flap upwards and then depress the button fully then release the button and allow the flap to settle back into position Evita 2 dura runs a self test Wait until the 10 second test phase is complete Evita 2 dura always begins ventilation with the start up values marked by an arrow on the on screen knobs To s...

Страница 39: ...and monitoring status effective before switching off the device The previous modes are displayed in the status line Previous ventilation mode example IPPV Previous patient mode A Adult Previous application mode tube or mask for optional NIV example NIV The key prev patient is not displayed by Evita 2 dura following a loss of data or removal of a previously used option e g NeoFlow thus preventing r...

Страница 40: ... off To select other start up settings see page 77 If no selection is made or if the rotary knob is not pressed to conﬁrm the new settings the apparatus automatically starts ventilation after 30 seconds with the last selected patient mode and ventilation mode and the associated ventilation parameters The main page is displayed on the Evita 2 dura screen The user can check and correct the settings ...

Страница 41: ...her ventilation mode 1 Press the relevant ventilation mode key briefly Its LED will flash The yellow indicators for the relevant parameters for the new ventilation mode flash in the parameter keys Set the new ventilation parameters 1 Press the relevant key its LED will stop flashing and remain constantly lit 2 Set the desired value turn the rotary knob Confirm value press the rotary knob The yello...

Страница 42: ... f Inspiration time Tinsp O2 concentration O2 Positive end expiratory pressure PEEP IPPV can be supplemented by the following ventilation parameters Trigger IPPVAssist for synchronising mandatory ventilation with attempted spontaneous breathing by the patient By activating the trigger and setting the trigger sensitivity the mandatory ventilator strokes are synchronised with the patient s spontaneo...

Страница 43: ...tilation PLV for manually limiting pressure peaks to the pressure limit Pmax The tidal volume remains constant as long as the pressure curve continues to show a short pressure plateau and the ﬂow curve shows a brief pause in the ﬂow between inspiration and expiration Volume monitoring is constantly active If the set tidal volume VT can no longer be applied the alarm Volume not constant is automati...

Страница 44: ...ches to CPAP mode Inspiration time Tinsp Sensitivity Trigger O2 concentration O2 Positive end expiratory pressure PEEP Additionally for SIMV ASB Pressure support PASB Pressure rise time Ramp SIMV SIMV ASB can be supplemented with the following ventilation parameters Apnoea ventilation for automatic switchover to volume controlled mandatory ventilation if the patient stops breathing If breathing st...

Страница 45: ...ally limiting pressure peaks using the Pmax pressure limit The tidal volume remains constant as long as the pressure curve continues to show a short plateau and the ﬂow curve shows a brief pause in the ﬂow between inspiration and expiration Volume monitoring is constantly active If the set tidal volume VT can no longer be applied the alarm Volume not constant is automatically generated For a detai...

Страница 46: ...e keys for the ventilation parameters Inspiration pressure Pinsp If Pinsp is set to the same value as PEEP the machine changes over to CPAP mode Frequency f If f 0 min the apparatus switches over to CPAP mode Inspiration time Tinsp Sensitivity Trigger O2 concentration O2 Positive end expiratory pressure PEEP Additionally for BIPAP ASB Pressure support PASB Pressure rise time Ramp BIPAP BIPAP ASB c...

Страница 47: ...ntilation parameters are displayed alongside the keys for the ventilation parameters Set the ventilation pattern for BIPAPAssist via the keys for the ventilation parameters Inspiratory pressure Pinsp Frequency f Inspiration time Tinsp Sensitivity Trigger O2 concentration O2 Positive end expiratory pressure PEEP Pressure rise time Ramp Absolute inspiratory pressure Pinsp To activate Press menu butt...

Страница 48: ...the cursor Hold the menu button other modes for approx 3 seconds or Press the rotary knob Otherwise Select CPAP ASB turn rotary knob activate press rotary knob The LED in the screen key CPAP ASB changes from green to yellow Ventilation mode CPAP ASB is now active and displayed in the status line CPAP ASB can also be activated when frequency f 0 in SIMV or BIPAP CPAP CPAP ASB can be expanded with t...

Страница 49: ...the patient stops breathing Evita 2 dura activates an alarm after the set alarm time TApnoea and starts volume controlled ventilation with the set ventilation parameters Frequency fApnoea Tidal volume VTApnoea The patient can breathe spontaneously during apnoea ventilation The apnoea ventilation frequency remains constant To set apnoea ventilation see page 52 ...

Страница 50: ...MMV ASB with the ventilation parameters Tidal volume VT Insp Flow Flow Frequency f Inspiration time Tinsp Sensitivity Trigger O2 concentration O2 Positive end expiratory pressure PEEP Additionally for MMV ASB Pressure assist PASB Pressure rise time Ramp To activate Press menu button other modes When MMV has been selected in the menu with the cursor Hold the menu button other modes for approx 3 sec...

Страница 51: ...sure peaks using the Pmax pressure limit The tidal volume remains constant as long as the pressure curve continues to show a short plateau and the ﬂow curve shows a brief pause in the ﬂow between inspiration and expiration Volume monitoring is constantly active If the set tidal volume VT can no longer be applied the alarm Volume not constant is automatically generated For a detailed description of...

Страница 52: ... patient can breathe spontaneously during apnoea ventilation and the mandatory ventilation strokes will be synchronised with the patient s spontaneous breathing The apnoea ventilation frequency remains constant To set apnoea ventilation Press menu button Settings Display Select screen key Apnoea Vent turn rotary knob Switch on apnoea ventilation press rotary knob The LED in the screen key changes ...

Страница 53: ...ob Confirm press the rotary knob The lower alarm limit does not have to be set for the airway pressure Paw because it is automatically coupled with the PEEP setting The alarm limits do not have to be set for the O2 concentration These limits are automatically coupled to the O2 concentration setting Lower alarm limit or settings up to 60 Vol O2 setting 4 Vol O2 for settings from 60 to 100 Vol O2 se...

Страница 54: ...on medium priority message 3 The yellow LED flashes Caution messages are marked with two exclamation marks Example Check settings Evita 2 dura generates a 3 tone sequence that is repeated every 20 seconds Advisory low priority message 3 The yellow LED lights up and remains constantly lit Caution messages are marked with one exclamation mark Example Malfunction fan Evita 2 dura generates a 2 tone s...

Страница 55: ...ault that triggered the alarm is still not remedied the audible alarm starts up again after this period If you wish to reactivate the audible alarm before the end of the 2 minute muting period 2 Press the g key again its LED goes out The message remains on the screen 3 Alarms which can be acknowledged via Alarm Reset must be acknowledged via the Alarm Reset key see Fault Cause Remedy page 84 Infor...

Страница 56: ... the Values key To select another pair of curves 2 Press the Curves key Measured values and curves can be selected see Combine displayed measured values page 75 and Combine displayed curves page 76 In the other screen pages these curves and measured values are not displayed The airway pressure is therefore continuously indicated by means of an analogue vertical bar display on the left hand side of...

Страница 57: ...ed tidal volume VTi and the ﬂow and volume curves This presupposes that leakage compensation has been activated see page 80 For safety reasons the measured values for the minute volume are not corrected To display the measured values of add on features e g Evita 2 dura CapnoPlus Select the Table 2 menu with the Table menu key Functional extensions of measured values e g CapnoPlus CO2 monitoring ar...

Страница 58: ...Operation 58 Curve freezing Curve freezing To study the curve s in detail 1 Press the Freeze key To return to displaying new curve s 1 Press the Freeze key again 031 D Evita 2 dura 1 507 ...

Страница 59: ...stroke deﬁned by the Pinsp and Tinsp settings For CPAP ASB pressure controlled ventilation stroke deﬁned by the PASB setting 1 Press and hold down the Insp hold key for as long as inspiration is required Either an automatic ventilation stroke that has just begun will be prolonged for as long as the key is held down or a new ventilation stroke will be started and prolonged for as long as the key is...

Страница 60: ... lungs Nebulising while in paediatric mode is continuous please note that nebulised medication will not enter the lungs during the expiratory phase of the breath Nebulising in the adult mode is synchronized with the inspiratory phase only and is not active during the expiratory phase Depending on the set O2 concentration the medicament nebuliser is supplied by the ventilator with medical air oxyge...

Страница 61: ...uliser in the vertical position Using hose clips route the nebuliser hose back to the ventilator along the expiratory hose For use during paediatric ventilation 3 Insert the catheter connector ISO cone Ø15 Ø11 into the inlet of the medicament nebuliser 4 Insert the adapter ISO cone Ø22 Ø11 into the outlet 5 Fit the corrugated hose 0 13 m long on to the outlet adapter 6 Remove the corrugated hose o...

Страница 62: ...itched off The ﬂow sensor is subsequently cleaned and calibrated automatically Remove residual medicament Strictly follow the Instructions for Use of the medicament nebuliser Warning the effect of aerosols on sensors ﬁlters and heat and moisture exchangers HME must be taken into account The measuring function of the ﬂow sensor may be impaired The ﬂow resistance of ﬁlters is liable to increase and ...

Страница 63: ...hed concentration is 25 higher than the set concentration During suction and for 2 minutes afterwards the lower alarm limit for the minute volume is switched off Before suction 1 Hold down the O2 Y Suction key until the yellow LED comes on Evita 2 dura ventilates the patient in the set ventilation mode with increased O2 concentration 100 O2 by volume in adult mode and a 25 higher O2 concentration ...

Страница 64: ...hment If there is still no reconnection after 120 seconds the oxygen enrichment programme is reeminated All alarms are immediately reactivated Evita 2 dura immediately continues ventilating in the set ventilation mode After reconnection Evita 2 dura continues ventilating in the set ventilation mode except that for ﬁnal oxygen enrichment the increased oxygen concentration of 100 by volume for adult...

Страница 65: ...old down the O key for about 3 seconds The Standby alarm tone is sounded 2 The Alarm Reset key can be used to switch off the Standby alarm tone The standby alarm tone can no longer be muted with the g key Terminating standby mode to continue ventilation 1 Press O key The LED goes out and ventilation commences If the patient mode is changed while on standby Evita 2 dura will determine new starting ...

Страница 66: ... calibration The calibration of the CO2 sensor optional can be checked during ventilation Calibrating the O2 sensor manually Before operation during the device check After replacing the O2 sensor wait for the 15 minute warm up time of the O2 sensor If the measured value and set value deviate from each other by more than 2 Vol The O2 sensor can be calibrated during ventilation Start calibration Pre...

Страница 67: ...vapours after disinfection Flow sensors which have been disinfected in ethanol must be left to dry in air for at least 30 minutes Press the Calib Conﬁg key Select the Flow screen key turn the rotary knob Start calibration press the rotary knob Display example Evita 2 dura uses the next inspiration phase for the calibration Short inspiration times are prolonged to about 1 second Message in the help...

Страница 68: ...alse alarms and ensure adequate monitoring Adjust both alarm limits for MV in line with the actual value Use additional monitoring e g SpO2 if necessary To determine the external ﬂow Press menu button Calib Conﬁg Select the menu External Flow via the menu button Sensor jj Select screen key Measure turn rotary knob confirm press rotary knob Yellow LED lights up in the Measure key The external ﬂow i...

Страница 69: ...not be immediately replaced An adequate external monitoring function must immediately be ensured Example Switching off Flow Monitoring Press the Calib Conﬁg menu key Select Sensor On Off with the Sensor jj menu key Example display Select the Flow on screen line turn the rotary knob Confirm press the rotary knob In the selection menu select off turn the rotary knob Confirm press the rotary knob The...

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Страница 71: ...its 73 Interface 74 Selecting the interface 74 Screen 75 Selecting the displayed combination of measured values 75 Selecting the displayed curves 76 Ventilation Defaults 77 Patient specific defaults 77 Default ventilation parameter values 78 Activating deactivating pressure limit Pmax 79 Apnoea ventilation on off 80 Leakage compensation on off 80 Set initial values for alarm limits 81 Default vent...

Страница 72: ... knob After the setting has been conﬁrmed the alarm tone is sounded once to enable you to judge the volume Setting the contrast Not possible with all types of monitor Press the Calib Conﬁg menu key Press the Device jj menu key The System menu is displayed Select the Contrast field on the screen turn the rotary knob Activate press the rotary knob Setting the contrast turn the rotary knob confirm pr...

Страница 73: ...firm press the rotary knob Select language turn the rotary knob Confirm press the rotary knob Setting the date and time Press the Calib Conﬁg menu key Press the Device j menu key With the Device j menu key select the Country menu Select the Day screen field turn the rotary knob Confirm press the rotary knob Set the date turn the rotary knob Confirm press the rotary knob Set the month year hour and...

Страница 74: ...onal Select the desired interface protocol in the Protocol screen field turn the rotary knob Confirm press the rotary knob Select the screen field corresponding to the desired interface parameter turn the rotary knob Confirm press the rotary knob Set the desired value turn the rotary knob Confirm press the rotary knob Adapting the interface protocols See the Instructions for Use of the device you ...

Страница 75: ...n page Press the Calib Conﬁg menu key Press the Display jj menu key With the Display jj menu key select the Values menu Display example To replace one displayed measured value by another Select the relevant screen field turn the rotary knob Activate press the rotary knob The selection list with all available measured values is then displayed on the right of the screen Display example Replacing MV ...

Страница 76: ...ess the Calib Conﬁg menu key Press the Display jj menu key The Curves menu appears Display example One displayed curve can be replaced by another Select the relevant field turn the rotary knob Activate press the rotary knob The list of all available curves to choose from is displayed on the right hand side of the screen Display example Replacing Paw Select the other curve Flow turn the rotary knob...

Страница 77: ...r Adult or Paediatric mode To set the values of the f and VT parameters active on starting up the device Press the Calib Conﬁg menu key Press the Ventilation jj menu key Enter code number 3032 The Patient menu is displayed Display example Select the VT screen field turn the rotary knob Confirm press the rotary knob Set the desired value turn the rotary knob Confirm press the rotary knob Patient sp...

Страница 78: ...lation jj menu key Display example Select the Pmax desired screen field turn the rotary knob Confirm press the rotary knob Set value turn the rotary knob Confirm press the rotary knob Default ventilation parameters The hospital speciﬁc defaults for your hospital can be entered in the table To restore the factory set defaults Select the Basic settings screen field turn the rotary knob Confirm press...

Страница 79: ...jj menu key Enter code number 3032 With the Ventilation jj menu key select the Parameter menu Display example Select the Pmax screen key turn the rotary knob The LED in the screen key Pmax lights up yellow Pmax is activated Deactivate Pmax press rotary knob the LED in the screen key Pmax lights up green Set the value for Pmax Press the Pinsp parameter key Set the desired value turn the rotary knob...

Страница 80: ...kage compensation on off Automatic leakage compensation allows the unit to compensate leakages up to 100 of the set tidal volume in all volume controlled ventilation modes The setting for Leakage compensation on off is saved and remains effective when the unit is restarted Press menu button Calib Conﬁg Press menu button Ventilation jj Enter the numerical code 3032 Select the menu Parameter via the...

Страница 81: ...re Paw because it is automatically coupled with the PEEP setting The alarm limits do not have to be set for the O2 concentration because they are automatically coupled with the O2 concentration setting Lower alarm limits for settings up to 60 Vol O2 set value 4 Vol O2 for settings from 60 to 100 Vol O2 set value 6 Vol O2 Upper alarm limits for settings up to 60 Vol O2 set value 4 Vol O2 for settin...

Страница 82: ...de Press the Calib Conﬁg menu key Press the Ventilation jj menu key Enter code number 3032 With the Ventilation jj menu key select the Mode menu Display example SIMV Select the screen field for the ventilation mode turn the rotary knob Confirm press the rotary knob The list of all available ventilation modes to choose from is then displayed on the righthand side of the screen Select other ventilat...

Страница 83: ...Fault Cause Remedy 83 Fault Cause Remedy 84 Fault Cause Remedy ...

Страница 84: ... bar Air supply pressure high Air supply pressure too high Air supply is not needed for FiO2 100 Vol Ensure pressure is less than 6 bar Airway pressure high The upper alarm limit for the airway pressure has been exceeded The patient is ﬁghting the ventilator cough Check patient condition check ventilation pattern correct alarm limit if necessary Ventilation hose buckled Check hose system and tube ...

Страница 85: ... key is pressed on the Remote Pad Remote Pad faulty Conﬁrm message with key Alarm Reset Remove Remote Pad Call DrägerService at the next opportunity Execute device check Device check not performed Perform device check page 31 Conﬁrm message with Alarm Reset key Exp hold interrupted The Exp hold key has been pressed for more than 15 seconds Release the Exp hold key Exp valve inop Expiration valve n...

Страница 86: ... communication failure between the display processor and main processor Conﬁrm message with key Alarm Reset Contact DrägerService if this message reoccurs frequently Leakage The measured leakage minute volume MVleak is 20 higher than the minute volume measured on the expiration side Check that the hose connection is leakproof Check that the tube is correctly ﬁtted Loss of data Lithium battery disc...

Страница 87: ...e if necessary Machine malfunction Call DrägerService Nebulisation interrupted Only in paediatric mode Nebulisation is only possible in pressure controlled ventilation or with AutoFlow Select the patient mode Restart nebulisation Acknowledge the alarm with Alarm Reset Only in paediatric mode only for ventilation with AutoFlow Flow sensor not ready for measurement Switch on ﬂow monitoring or calibr...

Страница 88: ...r alarm limit of the applied inspiratory tidal volume VT has been exceeded during three consecutive ventilation strokes Check condition of patient check pattern of ventilation correct alarm limit if necessary Leak or disconnection Check that hose system connections are leakproof Tidal volume high The inspiratory tidal volume VT has exceeded the upper alarm limit Check condition of patient check pa...

Страница 89: ...ors Y piece expiratory valve or in the event of severe soiling its individual components 94 Expiration valve and its individual parts after disinfection 94 Humidifier 94 Care list for Evita 2 dura Intensive Care Ventilator 95 Assembling 96 Mounting the expiration valve 96 Medication nebuliser 96 Breathing gas humidifier 96 Before re using on patient 96 Maintenance Intervals 97 Clean or replace coo...

Страница 90: ...tor and humidifier and remove their power plugs Drain the water traps and ventilation hoses Drain the water container of the humidifier Humidiﬁer Dismantle in accordance with the specific Instructions for Use and prepare for disinfecting sterilising Temperature sensor option Remove the temperature sensor from the Y piece do not tug on cable Remove the sensor probe from the back panel of Evita 2 du...

Страница 91: ...evice ports Remove the water traps from the ventilation hoses Remove the water containers from the water traps Prepare the ventilation hoses water traps and their collecting jars and the Y piece for cleaning and disinfection in a cleaning and disinfection machine Flow Sensor 6 Push the flow sensor to the left as far as it will go and 7 pull out The ﬂow sensor cannot be disinfected cleaned in a mac...

Страница 92: ...ater trap Remove the collecting jar Only strip down the expiration valve if badly soiled Unscrew stopper by hand and remove together with the diaphragm Do not disassemble the expiration valve any further Prepare the expiration valve for cleaning and disinfection in a cleaning and disinfection machine then for sterilisation by the hot steam method 045 046 047 ...

Страница 93: ...ountries where the DGHM list is not available we recommend the types of disinfectant given above Disinfectants often contain besides their main active agents additives that can also damage materials If in doubt ask the supplier manufacturer of the disinfectant cleaning agent Ventilator without ventilation hoses gas supply hoses temperature sensor Wipe disinfect e g with Buraton 10 F or Terralin Sc...

Страница 94: ...is not available Bath disinfect e g with Sekusept from Henkel Comply with the manufacturer s instructions Then rinse with clean water preferably from a soft water supply Shake water out thoroughly and leave the products to dry 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 t...

Страница 95: ...Part How often How Disinfecting and cleaning Sterilising Reusable components Recommended cleaning intervals Cleaning and disinfection machine 93 o C 10 minutes Wiping Bath immersion Steam 134 o C 10 minutes Evita 2 dura basic device per patient no outside no no Trolley Hinged arm Medical gas hoses per patient no outside no no Ventilation hoses Y piece Water traps Collecting jars per patient weekly...

Страница 96: ...housing from below and screw in tightly If the expiration valve has an additional water trap Fit collecting jar Medication nebuliser Assemble in accordance with separate Instructions for Use Installation see page 61 Breathing gas humidiﬁer Assemble in accordance with separate Instructions for Use Before re using on patient Assemble machine as described under Preparing for use on page 18 onwards Ca...

Страница 97: ...s can be returned to Dräger for disposal Ambient air ﬁlter Clean or replace after 4 weeks see page 98 Cooling air ﬁlter Replace after 1 year Dispose of with normal domestic waste Filters in the compressed gas inlets To be replaced by trained service personnel every 2 years Lithium battery for data protection To be replaced by trained service personnel every 2 years Disposal see page 99 Real time c...

Страница 98: ...filter with domestic waste Note the Instructions for Use of the option when using the optional DC power supply MB Removing and reinserting ambient air ﬁlter Filter must be cleaned or replaced when soiled or at the latest after 4 weeks Replace filter every year 2 Swivel port to the left 3 Unscrew the screw e g with a coin and remove the protective cover 4 Remove the ambient air ﬁlter from the prote...

Страница 99: ...Batteries must be disposed of as special waste Information may be obtained from the local environmental and public health authorities or from approved waste disposal companies O2 sensors can be returned to Dräger Correct disposal of apparatus at the end of its useful life After contacting the competent waste disposal company hand over Evita 2 dura for appropriate disposal The applicable legal regu...

Страница 100: ...100 ...

Страница 101: ...What s what 101 What s what 102 Control unit 102 Front connections 103 Back panel 104 Back panel with DC power supply MB 105 What s what ...

Страница 102: ...en ventilation and standby 11 Central turn and press rotary knob for selecting and confirming settings 12 Other Modes key for using other ventilation modes programmed on screen MT 50 97 1 2 3 26 25 24 23 22 21 20 19 18 17 16 15 14 13 12 11 4 5 6 7 8 9 10 13 Key for the BIPAP ventilation mode 14 Key for the SIMV ventilation mode 15 Key for the IPPV ventilation mode 16 Key for future functions 17 Va...

Страница 103: ...t EXHAUST NOT FOR SPIROMETERS 2 Flow sensor 3 Expiration valve with expiration port GAS RETURN 4 Latch for expiration valve 5 Nebuliser port 6 Inspiratory port GAS OUTPUT 7 Locking screw for protective cover behind it O2 sensor and ambient air filter 1 2 3 4 5 6 7 ...

Страница 104: ... oxygen 9 Connection for medical air 10 Temp socket for temperature sensor Rueckseite 18 1 2 3 4 5 6 7 17 16 15 14 13 12 11 10 9 8 11 CO2 socket for CO2 sensor optional 12 Connection for neonate flow sensor optional 13 Sync socket for C Lock ECG synchronisation for optional SpO2 measurement optional 14 SpO2 socket for functional SpO2 measurement optional 15 COM1 RS232C socket for RS232 interface e...

Страница 105: ...cket 8 Connection for oxygen 9 Connection for medical air 10 Temp socket for temperature sensor 7452002 18 17 1 2 3 4 5 6 7 16 15 14 13 12 11 10 9 8 11 CO2 socket for CO2 sensor optional 12 Connection for neonate flow sensor optional 13 Sync socket for C Lock ECG synchronisation for optional SpO2 measurement optional 14 SpO2 socket for functional SpO2 measurement optional 15 COM1 RS232C socket for...

Страница 106: ...106 ...

Страница 107: ...al Data 107 Technical Data 108 Environmental conditions 108 Settings 108 Performance data 109 Measured value displays 109 Monitoring 112 Operating data 112 Machine outputs 113 Materials used 114 Technical Data ...

Страница 108: ...ature Pressure Saturated Measured values with reference to the conditions of the patient lung Body temperature 37 o C steam saturated gas ambient pressure Accuracy 10 of set value or 10 mL whichever is greater Adults 0 1 to 2 0 L BTPS Accuracy 10 of set value or 25 mL whichever is greater Inspiratory Flow Paediatrics 6 to 30 L min Adults 6 to 120 L min Inspiratory pressure Pinsp 0 to 80 mbar Inspi...

Страница 109: ... 180 L min Equipment compliance with Aquapor humidiﬁer and patient tubing system for adults 2 mL mbar Inspiration resistance 2 3 mbar L s Expiration resistance 3 8 mbar L s Equipment compliance with Fisher Paykel MR 730 humidiﬁer and tubing system K for paediatric use 1 mL mbar Inspiration resistance 4 1 mbar L s Expiration resistance 4 1 mbar L s Additional functions Inspiratory relief valve Open...

Страница 110: ...ange 0 to 3999 mL BTPS Resolution 1 mL Accuracy 8 of measured value Tidal volume VTASB Inspiratory tidal volume during an ASB stroke Range 0 to 3999 mL BTPS Resolution 1 mL Accuracy 8 of measured value Frequency Measurement Breathing frequency ftot Spontaneous breathing frequency fspn Range 0 to 150 min Resolution 1 min Accuracy 1 min T0 90 approx 35 s Breathing gas temperature measurement Range 1...

Страница 111: ... 200 mbar L s 1 mbar L s Accuracy 20 of measured value R values may be considerably falsiﬁed as spontaneous breathing increases compliance with the measuring accuracy therefore cannot be guaranteed for spontaneous breathing Leakage minute volume MVleak Range 0 to 99 L min BTPS Resolution 0 1 L min or for values less than 0 1 L min 0 01 L min Accuracy 18 of measured value T0 90 approx 35 s Curve di...

Страница 112: ...larm limit for at least 20 seconds Range both alarm limits are automatically allocated to the set value less than 60 Vol 4 Vol 60 Vol and over 6 Vol Insp breathing gas temperature Upper alarm limit alarm when temperature reaches 40 o C Evita 2 dura can also be used without temperature sensor if the sensor is not connected on switching on Tachypnoea monitoring fspn Alarm when the spontaneous breath...

Страница 113: ...atic medicament nebuliser Medical air or O2 max 2 25 bar max 11 L min Automatic gas switch over if one gas fails inlet pressure 1 5 bar the device switches to the other gas Sound pressure for free ﬁeld measurement over a reﬂecting surface max 47 dB A Dimensions W x H x D Basic machine 530 x 290 x 450 mm Machine with trolley 580 x 1335 x 660 mm Weight Basic machine approx 27 kg Basic machine with t...

Страница 114: ...nalogue output optional for output of analog data Electromagnetic compatibility EMC conforming to European Directive 89 336 EEC Tested in accordance with EN 60601 1 2 Classiﬁcation as per EC Directive 93 42 EEC Annex IX II b UMDNS Code Universal Medical Device Nomenclature System Nomenclature for medical products 17 429 Part Appearance Material Ventilation hose milky transparent silicone rubber Wa...

Страница 115: ... PEEP 117 SIMV 118 ASB 119 BIPAP 120 BIPAPAssist 121 MMV 122 Measurements 123 Flow measurement 123 Automatic leakage compensation 124 Rapid Shallow Breathing RSB 126 Negative Inspiratory Force NIF 126 Insp O2 concentration during medicament nebulisation 127 Abbreviations 128 Symbols 130 Bibliography 131 Description ...

Страница 116: ... the plateau Pplat in the curve Paw t Manual pressure limiting with Pmax Evita 2 dura can prevent peaks of pressure 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 curve shows a brief pause of zero ﬂow between inspiration and expiration Evita 2 dura performs this f...

Страница 117: ... cases the sigh function is achieved by increasing the ventilation stroke however due to the short time available this form of sigh only marginally improves the ﬁlling of the slow alveoli In Evita 2 dura the sigh operates during expiration with an intermittent PEEP for two ventilation strokes every 3 minutes The average airway pressure is higher and a longer ﬁlling time is normally available To av...

Страница 118: ...efore would normally result in an undesirable increase in the effective SIMV frequency Evita 2 dura adds back the reduced SIMV time by prolonging the subsequent spontaneous breathing phase by the SIMV time difference Δ T thus preventing an increase in SIMV frequency The frequency parameter f remains constant This parameter in combination with the tidal volume VT sets the minimum ventilation If the...

Страница 119: ... Evita 2 dura supports the insufﬁcient spontaneous breathing of the patient with a high peak ﬂow With a slow increase in pressure Evita 2 dura begins gently with regular inspiratory ﬂow The patient has to take over more breathing effort and so the tone of the breathing muscles gradually improves With patient adjusted pressure increase and the preset ASB level PASB the patient s own breathing activ...

Страница 120: ...n paediatric mode For expiration times shorter than 5 seconds or 1 5 seconds respectively the trigger window covers the entire expiration time At Pinsp level the trigger window is 1 4 x Tinsp seconds long This smooth adaptation to the patient s spontaneous breathing requires less sedation so that the patient returns to spontaneous breathing more rapidly As in all pressure controlled ventilation mo...

Страница 121: ...sure Pinsp and or frequency f BIPAPAssist Biphasic Positive Airway Pressure Assisted Pressure controlled assisted ventilation The inspiratory strokes are the same as for BIPAP except that the change from Pinsp to PEEP is not synchronised with expiration by the patient The duration of Pinsp depends on Tinsp The patient can breathe spontaneously throughout the ventilation process Every detected spon...

Страница 122: ...balancing process also takes account of the extent by which the set minimum ventilation has been exceeded This positive allowance is progressively reduced to zero by Evita 2 dura within a maximum of 7 5 seconds after apnoea In other words the response time of Evita 2 dura before activating mandatory ventilation is automatically adapted to the preceding cycle of spontaneous breathing If this sponta...

Страница 123: ... for adult patients due to their relatively high lung compliance in relation to the much lower compliance of the ventilation hoses However since only the volume attained and surrendered by the lung is relevant to the efﬁciency of ventilation and since higher differences are possible during paediatric ventilation Evita 2 dura provides basic compensation for hose compliance during ventilation Compen...

Страница 124: ...nder BTPS conditions Automatic leakage compensation Evita 2 dura determines the difference between the delivered ﬂow on the inspiration side and the measured ﬂow on the expiration side This difference provides a measure of the amount of leakage and is displayed by Evita 2 dura as the leakage minute volume MVleak Evita 2 dura can compensate for this leakage in volumecontrolled ventilation Example T...

Страница 125: ...kage compensation the set VT determines the volume to be delivered to the patient This example has been simpliﬁed In fact the calculated leakage correction takes into account the pressures in the hose system A higher percentage volume is lost on the inspiration side than on the expiration side because the pressure during inspiration is higher The displayed leakage minute volume MVleak is based on ...

Страница 126: ...ve Inspiratory Force index NIF measures the patient s maximum inhalation effort after exhaling The patient system is closed during measurement of the 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...

Страница 127: ... switching over the compressed gases medical air and oxygen in synchronisation with inspiration In paediatric ventilation the nebuliser is operated continuously with medical air or oxygen in alternation The drive gas of the medicament nebuliser 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 at a mi...

Страница 128: ...itive End Expiratory Pressure Sigh IPPV Intermittent Positive Pressure Ventilation IPPVAssist Trigger Assist Intermittent Positive Pressure Ventilation IRV Inversed Ratio Ventilation Ventilation with inversed inspiration expiration ratio ISO 5369 International standard for mechanical ventilators Lung Ventilation MMV Mandatory Minute Volume Ventilation MV Minute Volume MVleak Leakage minute volume ...

Страница 129: ...129 Description Abbreviations VTe Expiratory tidal volume VTi Inspiratory tidal volume Vtrap Volume trapped in the lung by intrinsic PEEP and exhaled during subsequent expiration Abbreviation Deﬁnition ...

Страница 130: ...n screen g Suppress audible alarm for 2 minutes Alarm Reset Acknowledge alarms Protect ventilation parameters and ventilation mode O Standby Operation Select other combination of measured values Select other curve s _ Lower upper alarm limit Observe Instructions for Use Protection class Type B Protection class Type BF Insert ﬂow sensor Unlocking expiration valve Evita Remote Pad Nurse call Exp Exp...

Страница 131: ...en Anästhesiol Intensivmed Notfallmed Schmerzther 26 1991 337 342 5 Vincent J L Yearbook of Intensive care and Emergency Medicine Springer Verlag 1993 6 E Voigt BIPAP Anwendungshinweise und Kasuistik Dräger Mitteilungen Medizintechnik aktuell 1 94 7 E Bahns BIPAP Zwei Schritte nach vorn in der Beatmung Dräger Fibel zur Evita Beatmung 8 Yang K L Tobin M J A Prospective Study of Indexes Prediction t...

Страница 132: ...re brackets 84 03 345 11 Temperature sensor 84 05 371 12 23 Hose set adult blue socket 84 12 092 12 Spiral hose adult silicone 0 6 m 21 65 627 13 13 1 Water trap 84 04 985 13 1 Water container 84 03 976 14 Spiral hose adult silicone 0 35 m 21 65 619 15 Connector M 25 647 16 ISO elbow connector M 25 649 17 Y piece straight 84 05 435 18 Catheter connector straight size 12 5 set of 10 M 23 841 19 Hos...

Страница 133: ...amps for rail 84 11 074 28 Double temperature sensor 84 11 048 29 30 Humidiﬁer chamber MR 340 84 11 047 30 Filter paper set of 100 not illustr 84 11 073 31 Single strand wire 1 5 m not illustr 84 11 050 32 43 Hose set paediatrics Fisher Paykel 84 12 081 32 32a Condensation trap expiration 84 09 627 32 Water container 84 03 976 33 Double conical connector 84 09 897 34 Temperature sensor mounting 84...

Страница 134: ...heter connectors 84 12 081 23 47 020 Bacterial ﬁlter MX 02 650 Special accessories Instrument tray 84 11 621 Holder for quick reference manual 84 11 615 Wall bracket module 2000 Type 13 alternative to trolley 84 08 613 Pneumatic medicament nebuliser 84 12 935 Flow sensor cover 84 14 714 For manual ventilation Resutator 2000 21 20 046 Paediatric Resutator 2000 21 20 984 Baby Resutator 21 20 941 Hoo...

Страница 135: ...05 371 Replacement set of lids for Aquapor 84 06 135 Name Description Order No Aquapor bowl 84 04 739 Aquapor ﬂoat 84 04 738 Spiral hose adult silicone 0 6 m 21 65 627 Spiral hose adult silicone 0 35 m 21 65 619 Water trap 84 04 985 Water container 84 03 976 Hose clamp 84 03 566 Connector M 25 647 Y piece 84 05 435 Catheter connector straight size 12 5 set of 10 M 23 841 Corrugated hose 84 02 041 ...

Страница 136: ...ause Remedy 84 Flow sensor 18 91 calibrating 67 Front connections 103 Gas supply 26 Heat and moisture exchanger 20 Information 55 Interface 74 Language 73 Leakage compensation 80 124 Maintenance 6 Maintenance Intervals 97 Manual inspiration 59 Measured Values 56 Measuring unit 73 Medicament nebulisation 60 Medicament nebuliser 91 Message 84 MMV 122 MMV MMV ASB 50 NIF 126 Nurse call 29 O2 sensor 19...

Страница 137: ...dex UMDNS Code 114 Ventilation Controls 10 Ventilation defaults 77 Ventilation hoses 21 23 91 Ventilation mode 10 Ventilation Modes 41 Ventilation parameters 10 Volume of the audible alarm 72 What s what 102 ...

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Страница 139: ...139 ...

Страница 140: ...tructions for Use are provided for general information only and are not intended for use with any speciﬁc machine or device ç Directive 93 42 EEC concerning Medical Devices 90 37 253 GA 5664 822 en Dräger Medical GmbH Edition 7 2015 01 Subject to alteration As of 2015 08 Dräger Medical GmbH changes to Drägerwerk AG Co KGaA ...

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