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Instructions for use

Oxylog VE300

WARNING

To properly use this medical device,
read and comply with
these instructions for use.

Emergency and transport ventilator
Software 1.n

Содержание Oxylog VE300

Страница 1: ...Instructions for use Oxylog VE300 WARNING To properly use this medical device read and comply with these instructions for use Emergency and transport ventilator Software 1 n ...

Страница 2: ...2 Instructions for use Oxylog VE300 SW 1 n This page has been left blank intentionally ...

Страница 3: ...h carrying system 20 3 3 Breathing circuits 21 3 4 Range of functions 23 3 5 Abbreviations 24 3 6 Symbols 25 4 Operating concept 28 4 1 Control elements 28 4 2 Structure of the screen 29 4 3 Color concept 32 4 4 Selecting and setting 32 5 Assembly and preparation 33 5 1 Assembling the main device with carrying system option 33 5 2 Attaching the accessories bag option 35 5 3 Internal battery 35 5 4...

Страница 4: ...reathing circuit 75 9 4 Setting the HME correction 75 9 5 Setting the ventilation mode for the ventilation category Ventilation volume 75 9 6 Setting the CO2 cuvette type option 76 9 7 Using the Bluetooth function option 76 9 8 Activating the screenshot function option 77 9 9 Advanced system setup 78 10 Logbook and system information 86 10 1 Logbook 86 10 2 System information 87 11 Troubleshooting...

Страница 5: ...Disposal of the breathing circuit and the CO2 cuvettes 109 15 Technical data 110 15 1 Safety information 110 15 2 Device specifications 110 15 3 Ambient conditions 112 15 4 Settings 113 15 5 Performance data 114 15 6 Displayed measured values 115 15 7 Monitoring 116 15 8 Operating data 118 15 9 Materials used 119 15 10 Pneumatic diagram 120 15 11 EMC Declaration 121 15 12 Emission of high frequenc...

Страница 6: ...ics indicate device labels and screen texts 1 Consecutive numbers indicate steps of action with the numbering restarting with 1 for each new sequence of actions Bullet points indicate individual actions or different options for action Dashes indicate the listing of data options or objects A Letters in parentheses refer to elements in the related illustration A Letters in illustrations denote eleme...

Страница 7: ...rademark owner Dismozon BODE Chemie Korsolex BODE Chemie Neodisher Chemische Fabrik Dr Weigert Buraton Schülke Mayr Perform Schülke Mayr Mikrozid Schülke Mayr acryl des Schülke Mayr Actichlor Ecolab Sekusept Ecolab Oxycide Ecolab USA Dispatch Clorox Descogen Antiseptica Virkon DuPont BruTab 6S Brulin Klorsept Medentech Trademark BIPAP1 1 Licensed trademark ...

Страница 8: ...ard ships In accident and emergency departments During intrahospital transport of ventilated patients WARNING Risk of patient injury The device is not intended for long term use Do not use the device as an intensive care ventilator WARNING Risk of patient injury and device malfunction Do not use the device in hyperbaric chambers This may result in danger to the patient and malfunctioning of the de...

Страница 9: ... the event of an external power supply failure the device automatically switches to the internal battery 2 6 Target groups 2 6 1 Intended users The device is intended for use by and under the supervision of trained healthcare professionals e g doctors nurses emergency medical technicians respiratory therapists and paramedics 2 6 2 Definition of target groups The target groups may only carry out th...

Страница 10: ...he action steps The following warning signs and signal words indicate precautionary statements and differentiate the possible consequences of non compliance 2 8 Basic safety instructions 2 8 1 Instructions for use Failure to use the product in accordance with the information contained in these instructions for use may result in personal injury and property damage Follow these instructions for use ...

Страница 11: ...rganization of this product must ensure the following The target group has the required qualifications e g has undergone specialist training or acquired specialist knowledge through experience The target group has been trained to perform the task The target group has read the sections of these instructions for use relating to the activity concerned and noted the safety instructions and precautiona...

Страница 12: ...atible with this product are listed in the list of accessories supplied with the product Do not use any antistatic or electrically conductive breathing circuits 2 8 9 Connected devices Any connected devices or device combinations not complying with the requirements mentioned in these instructions for use may compromise the correct functioning of the medical device and lead to an electric shock Bef...

Страница 13: ...e the ventilator is being operated in order to maintain ambient oxygen concentration below 25 Vol to prevent risk of fire Do not use any combustible gases or anesthetic gases with the ventilator Do not use any flammable drugs with the ventilator Special care must be taken when using oxygen fittings Do not grease or lubricate cylinder valves and pressure reducers or device ports and do not handle w...

Страница 14: ...ns relating to disinfectants and cleaning agents Make sure that the device is adequately ventilated after reprocessing Risk of infection The device must be reprocessed otherwise there is an increased risk of infection and the function of the device may be impaired Observe the hygiene regulations at the operating location e g hospital or ambulance station including the reprocessing intervals and re...

Страница 15: ...st not rely solely on the built in ventilation monitoring The user bears full responsibility for proper ventilation and for the patient s safety in all situations Do not make therapeutic decisions based solely on individual measured values and monitoring parameters An etCO2 value is insufficient as a basis for medical decisions Always consider multiple values as part of the decision making process...

Страница 16: ...ng transport there is a risk of selecting undesired settings or the device falling down Transport the device safely and in a stable manner Place the device on a flat and stable surface for operation 2 10 Additional information 2 10 1 Training User training is offered by the responsible Dräger organization see www draeger com ...

Страница 17: ...set tings D LED To display the state of charge of the battery and the power supply E Start dialog key To return from any dialog to the start dialog F Screen rotation key To rotate the screen orientation by 180 G Screen To display and operate the applica tion specific dialog pages H Alarm silence key To suppress the acoustic alarm signal for 2 minutes I Color LEDs To visually indicate alarms J USB ...

Страница 18: ...rview Rear 28170 No Designation Description A Carrying handle To transport the device B Compressed gas port with standard connector To connect an O2 compressed gas hose C Connector for the DC power supply To connect to an external power supply A B C ...

Страница 19: ...he device 28171 No Designation Description A Breathing circuit port To connect a disposable or reusable breathing circuit B Measuring line ports To connect the measuring lines of the breathing circuit C CO2 sensor port To connect the CO2 sensor cable D Emergency air and ambient air inlet To suction ambient air E Additional quick coupling port For additional gas supply from the wall terminal unit t...

Страница 20: ...agonal fixing of the carrying strap option C Closure To open the carrying system Height adjustable For further infor mation see the following chapter Assembling the main device with carrying system option page 33 D Hinge when the closure is raised To open the carrying system Height adjustable For further infor mation see the following chapter Assembling the main device with carrying system option ...

Страница 21: ...iption A Rubberized feet To ensure reliable device stability B Connecting area for the carrying system holder To use the device with the carrying system holder C Charging pins To use the device with the carrying system holder A C B B A 30060 No Designation A Elbow B Pressure sensor C Breathing valve D Breathing hose E Pressure measuring line A E B C D ...

Страница 22: ...usable breathing circuit for adults with Plus option 33256 No Designation A Red protection cap B Elbow C Breathing valve D Breathing hose E Device side connectors 28172 No Designation A Elbow B Flow sensor C Breathing valve D Breathing hose E Flow and pressure measuring lines D C B A E A E B C D ...

Страница 23: ...on Pressure support option prerequisite Plus option is enabled in the ventilation modes SPN CPAP VC SIMV PC BIPAP Non invasive ventilation in the ventilation modes SPN CPAP PS and PC BIPAP PS For a detailed description of the ventilation modes and the additional settings see page 56 For information on abbreviations see page 24 In these instructions for use the unit of measurement for airway pressu...

Страница 24: ... Ratio of inspiratory time to expiratory time IPX4 Degree of protection against ingressing liquids level 4 kPa Kilopascal L min Liter per minute LED Light emitting diode mbar Millibar MEDIBUS X Communication protocol for medical devices with uniform data definition for all devices min Minute mmHg Millimeter of mercury MRI Magnetic resonance imaging MVe Expiratory minute volume MVi Inspiratory minu...

Страница 25: ...ntrolled synchronized intermittent mandatory venti lation VDC Volt direct current Vol Percentage gas ratio related to total volume VT Tidal volume VTe Expiratory tidal volume VTi Inspiratory tidal volume Abbreviation Explanation Symbol Explanation Manufacturer Date of manufacture WEEE label Directive 2012 19 EU Follow the instructions for use Warning Strictly follow these instructions for use Atte...

Страница 26: ...g to the regulations for lithium ion batteries Start standby key Key to silence acoustic alarm signals for 2 minutes Start dialog key Screen rotation key Inlet for ambient air Warning Emergency air inlet Do not block Part number Serial number Lot number Revision index Nominal weight Maximum weight Keep away from rain Keep away from sunlight Symbol Explanation REF LOT ...

Страница 27: ... use if package damaged Do not reuse For indoor use only Defibrillation proof applied part type BF Not made with natural rubber latex Keep free of oil and grease Quantity Use by Lower alarm limit Upper alarm limit Slope steep medium flat Patient category Adult Patient category Child Screenshot Bluetooth USB port Symbol Explanation NON STERILE LATEX ...

Страница 28: ...4 1 Control elements 28174 No Designation A Rotary knob for making selections changing and confirming settings B Start dialog key to return from any dialog to the start dialog C Key to rotate the screen orientation by 180 D Key to silence acoustic alarm signals for 2 minutes A B C D ...

Страница 29: ...splay additional information e g while adjusting parameters 28206 No Designation A Patient category B Ventilation category CPR Ventilation volume Ventilation pressure CPAP and ventilation mode VC CMV VC AC VC SIMV PC BIPAP SPN CPAP C Display of power supply and remaining duration of battery operation D Oxygen mode 100 O2 O2 air mix E Display of current gas consumption F Button to switch or exit th...

Страница 30: ... result of the last system test are displayed in the standby mode area 28210 No Designation A Text Standby and date of last system test or alarm message B Step 1 Select the patient category buttons Adult Child C Step 2 Select the ventilation category buttons CPR Ventilation volume Ventilation pressure CPAP D Step 3 Start ventilation button Start ventilation A B C D ...

Страница 31: ... Flow CO2 option B Display of measured values for the parameters PIP RR MVe option VTe option and etCO2 option C Button Alarm settings For further information see the following chapter Setting alarm limits page 71 D Button More settings E Therapy controls for frequently used parameters depending on the venti lation setting e g VT and RR or PEEP and Pmax The black triangle indicates the preset para...

Страница 32: ...d changed the message To confirm the setting press the rotary knob is also displayed in the notification field This message starts to flash after a short time Canceling the setting or changing procedure If the parameter shall not be changed color still yellow the following options allow the existing settings to be kept Touch the changed parameter again This resets the parameter selection and chang...

Страница 33: ...t protrude beyond the protection bar otherwise it may catch on objects WARNING Risk of patient injury If the quick coupling port of the Alduk IV pressure reducer is used the connection will protrude beyond the standard protection bar Always use the wide protection bar when using the quick coupling port of the Alduk IV pressure reducer The protection bar on the pressure reducer can be extended by a...

Страница 34: ...with a hexagon key remove the protective plate and loosen the 2 screws beneath the plate Set the catch A so that the ventilator is resting horizontally on the cylinder and then re tighten the screws Refit the protective plate Loosen the 2 screws of the closure set the closure to the same scale value as the hinge and then re tighten the screws Make sure that the closures do not wiggle easily when c...

Страница 35: ...on bar to ensure functional integrity and replace them if necessary 5 2 Attaching the accessories bag option 1 Pull on the buttons fastened inside the accessories bag 2 Push the outside openings of the buttons onto the pins on the side of the device 3 Release the buttons 5 3 Internal battery Internal power is provided by means of a removable rechargeable battery For further information see the fol...

Страница 36: ...harge the battery and to extend the duration of operation use either DC DC converter or Power supply unit For further information see the following chapter Operating data page 118 Always position the device so it can be easily disconnected from the external power supply CAUTION Risk of patient injury If the external power supply fails and no charged battery is installed ventilation of the patient ...

Страница 37: ...ors there is a risk of electric shock and damage to the device Do not use the power supply unit outdoors Do not touch the power supply unit and the patient at the same time 1 Insert the power plug into the power socket 2 Connect the DC connector to the device s DC socket 3 Check if the device is connected correctly to the external power source The LED next to the battery status indicator lights up...

Страница 38: ... dosage valves or flowmeters in the device s gas supply line To avoid insufficient oxygen supply during use always check the oxygen cylinder pressure before use 1 Connect the pressure reducer B to the oxygen cylinder A 2 Connect the oxygen compressed gas hose C to the standard port D on the device 3 Connect the oxygen compressed gas hose C to the pressure reducer B 4 Rotate the cylinder valve slow...

Страница 39: ...it until it locks in place and the oxygen supply is assured Connecting the built in oxygen cylinder For information on the correct assembly of the main device with carrying system see page 33 WARNING Risk of ventilator malfunction Components installed in the gas supply line might cause malfunctions Do not install dosage valves or flowmeters in the device s gas supply line To avoid insufficient oxy...

Страница 40: ...owly and open it fully Connecting the device to a central gas supply by the quick coupling port To maintain continuous oxygen supply when switching from the built in oxygen cylinder supply to central gas supply the device can also be connected to a central gas supply system via the quick coupling port while the cylinder supply is active 1 Make sure that the patient is receiving oxygen from the bui...

Страница 41: ...ut the patient at risk Make sure that the breathing hoses are not bent or twisted CAUTION Risk of patient injury A breathing hose that does not correspond to the device settings may put the patient at risk When connecting a breathing hose make sure that the hose settings in the configuration dialog correspond to the connected hose For further information see the following chapter Setting the breat...

Страница 42: ...valve C To do so align the pressure sensor D on the breathing valve using the grooves in the pressure sensor 4 Push the elbow onto the pressure sensor D Connecting the breathing hose and the pressure measuring line 1 Connect the breathing hose A to the breathing valve 2 Connect the pressure measuring line B to the connector of the pressure sensor 3 Connect the pressure measuring line to the device...

Страница 43: ...may put the patient at risk Do not remove damage or bend the rubber disk A in the housing 1 Place the diaphragm B in the breathing valve housing C Make sure that it is fitted correctly 2 Mount the cover A and turn it about 60 clockwise until it engages 3 Push the flow sensor D onto the breathing valve C To do so align the flow sensor D on the breathing valve C using the grooves in the flow sensor ...

Страница 44: ...on Disposable hoses are shipped clean but non sterile WARNING Risk of patient injury Soiling of the disposable breathing circuit may put the patient at risk Open the packaging of disposable breathing circuits only immediately before use 1 Connect the pressure measuring line to the device 2 Connect the breathing hose to the device s gas outlet 5 7 4 Connecting the disposable breathing circuit for a...

Страница 45: ...usted for use with an HME For further information see the following chapter Setting the HME correction page 75 Connect the bacteria filter or HME to the elbow as follows Connect the bacteria filter HME or catheter mount A to the patient port on the breathing circuit B 5 9 Connecting the CO2 sensor and the CO2 cuvette option 1 Disconnect the elbow A from the flow sensor or pressure sensor 2 Connect...

Страница 46: ...accuracy The CO2 sensor cable may be extended with a maximum of one extension cable For further information see the following chapter List of accessories page 125 5 10 Attaching the device to rail systems The device can be attached to various rail systems or to stretcher bars with diameters up to 35 mm 1 4 in by means of a rail holder optional The distance from the stretcher bar or rail to the wal...

Страница 47: ... battery charge Flashing green The battery is charging Lit green The battery is fully charged Yellow A battery is not inserted or cannot be charged The LED beside the battery symbol remains unlit while the ventilator is being operated by the battery An external battery charger connected to the mains power supply can be used to charge an extra battery For further information see the following chapt...

Страница 48: ...ng operation the patient may be put at risk Before starting operation check the cylinder pressure on the pressure gauge of the pressure reducer so as to rule out the possibility of insufficient oxygen supply during operation Always have a full replacement oxygen cylinder ready Example for oxygen supply Cylinder pressure measured on the pressure gauge of the pressure reducer 20000 kPa 200 bar Filli...

Страница 49: ...t be performed in the following cases Once a day e g at the start of a shift At least every 6 months The system test comprises the following single tests Pneumatic test Leakage test The system test takes about 1 minute 6 3 1 1 Performing the system test 1 To switch the ventilator on briefly press the start standby key The ventilator performs an automatic self test then the standby screen is displa...

Страница 50: ... displayed on screen 4 4 8 To exit touch the Finish button in the bottom right hand corner of the screen 6 3 2 System test with breathing circuit A system test with breathing circuit must be performed in the following cases After every reprocessing of the breathing circuit At least every 6 months The system test with breathing circuit comprises the following single tests Pneumatic test Breathing c...

Страница 51: ... button in the bottom right hand corner of the screen 6 3 3 Troubleshooting WARNING Risk of patient injury If the system test or system test with breathing circuit was not completed successfully the ventilator is not ready for operation Never use a ventilator that is not ready for operation If one of the system tests was not completed successfully 1 For further information see the following chapte...

Страница 52: ...en the standby screen is displayed 2 Connect the CO2 sensor to the device 3 To move to screen 2 of the dialog touch the button 1 in the top right hand corner of the screen 4 Touch the button Test calibration A 5 Touch the button CO2 zero calibration B The CO2 zero calibration can be canceled at any time by touching the X button in the top right hand corner of the screen Shortly after connecting th...

Страница 53: ...circuit If CO2 zero calibration was not successful The screen displays the alarm message CO2 zero calibration failed Repeat the CO2 zero calibration If CO2 zero calibration is still not successful 1 Check whether the CO2 sensor is soiled and clean the CO2 sensor if necessary If the sensor is faulty replace the sensor 2 Repeat the CO2 zero calibration 6 4 2 Performing the CO2 filter test option 1 T...

Страница 54: ...ter with the Next button 8 The CO2 filter test starts and the message Filter test of CO2 sensor in progress is displayed A bar indicates that the CO2 filter test is in progress 9 When the CO2 filter test is completed a message is displayed indicating the result 10 To exit touch the Finish button in the bottom right hand corner of the screen 11 Reconnect the CO2 sensor to the CO2 cuvette If the CO2...

Страница 55: ...o not cover the device e g with a blanket To switch the device on 1 Briefly press the start standby key A The device briefly displays the startup screen indicating the device name and the installed software version Automatic self test Every time it is switched on the device performs an automatic self test involving a test of the acoustic alarm signals as well as an internal device test The device ...

Страница 56: ...100 mL corresponds to a child weighing approx 13 to 17 kg 28 7 to 37 5 lb with a tidal volume of 6 to 8 mL per kilogram of body weight which corresponds to an age of 2 to 4 years 7 3 Selecting the ventilation mode The ventilation mode is selected based on the selected ventilation category 7 3 1 VC CMV VC AC VC CMV Volume Controlled Controlled Mandatory Ventilation Volume controlled ventilation wit...

Страница 57: ...tion field VC AC Volume Controlled Assist Control For synchronization with the patient s inspiratory efforts For patients with partial spontaneous breathing If a trigger value is set in ventilation mode VC CMV the ventilation mode automatically changes to VC AC When the trigger sensitivity is activated and set the mandatory breaths are synchronized with the patient s inspiratory efforts A low valu...

Страница 58: ... both steps and L min Deactivating the trigger 1 Touch the More settings button 2 Select the therapy control Trigger A The therapy control changes color turning yellow 3 Set the value to Off therapy control full to left or right 4 Confirm the setting The therapy control changes color back to green The ventilation mode VC CMV is displayed on screen again 7 3 2 VC SIMV VC SIMV PS option VC SIMV Volu...

Страница 59: ...upport Psupp Successful patient triggering is briefly indicated by an asterisk in the middle of the waveform field at the top When setting the respiratory rate RR or the inspiratory time Ti the corresponding value I E is automatically displayed in the notification field VC SIMV PS The following parameters can be adjusted on screen in addition to the parameters of ventilation mode VC SIMV Pressure ...

Страница 60: ...ry proportion of the total minute volume MVe and reduction of the pressure support Psupp 1 Adjust the following parameters using the therapy controls A Inspiratory pressure Pinsp B Positive end expiratory pressure PEEP 2 Tap the More settings button C to open the settings screens 3 On the Basic settings screen E adjust the following parameters and settings A Inspiratory oxygen concentration FiO2 1...

Страница 61: ... support Psupp if a value of 0 mbar is set for Psupp Flat slope slow pressure rise Medium slope medium pressure rise Steep slope rapid pressure rise 7 3 4 SPN CPAP SPN CPAP PS Option SPN CPAP Spontaneous Continuous Positive Airway Pressure WARNING Risk to the patient due to hypoventilation There is a risk of hypoventilation when using CPAP for patients with insufficient spontaneous breathing Only ...

Страница 62: ... Psupp above PEEP C Trigger sensitivity Trigger D Pressure rise time Slope E The parameter Trigger can only be changed when a value 0 mbar has been set for Psupp The parameter Slope can then be changed Flat slow pressure rise Medium medium pressure rise Steep fast pressure rise 7 3 5 Cardiopulmonary resuscitation CPR WARNING Risk of patient injury In the ventilation category CPR the minute volume ...

Страница 63: ... mix B Maximum airway pressure Pmax C Positive end expiratory pressure PEEP D Ratio of inspiratory time to expiratory time I E 7 4 Changing the ventilation mode It is possible to change the ventilation mode at any time during operation By means of the screen To go back to the ventilation category selection at any time during operation 1 Touch the X button The ventilation category selection screen ...

Страница 64: ...P or SPN CPAP PS In this ventilation mode NIV is the default setting In the pressure controlled ventilation mode PC BIPAP NIV is also available but it is not the default setting The device automatically adjusts to the requirements of non invasive ventilation Mask leakage is detected by the device and compensated for This means that the leakage for the displayed measured values VTe and MVe has alre...

Страница 65: ...directions WARNING Risk of aspiration A high airway pressure may lead to aspiration Avoid high airway pressure Deactivating NIV 1 In the ventilation mode SPN CPAP or SPN CPAP PS touch the More settings button In the ventilation mode PC BIPAP touch the More settings button followed by the Additional settings button 2 For NIV touch the Off button and confirm The adjunct NIV is hidden in the on scree...

Страница 66: ...tion which can be realized depends on the mean airway pressure and the inspiratory flow The O2 concentration can never be below 40 This is demonstrated in the following schematic diagrams O2 concentration which can be realized at a mean airway pressure of 5 mbar 5 cmH2O O2 concentration which can be realized at a mean airway pressure of 15 mbar 15 cmH2O O2 concentration which can be realized at a ...

Страница 67: ...hat toxic and infectious constituents cannot enter the breathing gas The patient must immediately be transferred to a breathable atmosphere in order to prevent inhalation of toxic and infectious air when spontaneous breathing resumes Use a bacteria filter 7 7 Switching to standby mode and turning off the device After disconnecting the patient switch the ventilator to standby mode or turn it off To...

Страница 68: ...ing down is displayed Forcing a device shutdown 1 Press the start standby key A for about 8 seconds While the key is held the Forced shutdown alarm sounds WARNING Risk of patient injury The patient will no longer be ventilated if the start standby key is held for at least 8 seconds Only force a device shutdown if no patient is connected to the device or the patient no longer needs to be ventilated...

Страница 69: ...ing number of exclamation marks Warning Caution Note Warning High priority alarm The alarm indicator flashes red The alarm message is highlighted by 3 prefixed exclamation marks and a red background The acoustic alarm signal consists of 5 tones repeated twice about every 6 seconds Caution Medium priority alarm The alarm indicator flashes yellow The alarm message is highlighted by 2 prefixed exclam...

Страница 70: ...and is color highlighted B When several alarms are active simultaneously the alarm with the highest priority is displayed The acoustic alarm signal sounds When an alarm is triggered by a measured value the measured value in question also lights up red or yellow according to the alarm priority When the cause of an alarm has been eliminated the acoustic alarm signal stops and the alarm message disap...

Страница 71: ...alarm signals are reactivated and the LED in the yellow key field goes out To be notified of new acoustic alarm signals during the alarm silencing the 2 minute alarm suppression must be reset To cancel the silencing before the 2 minutes elapse Press key A again 8 3 2 In the event of a power failure In the event of a power failure ventilation volume measurement and alarms do not operate An acoustic...

Страница 72: ...pressure is too low To set the alarm limits for RR MVe option and etCO2 option 1 In operation mode touch the Alarm settings button A 2 The following settings can be made depending on the selected options For the respiratory rate RR Upper alarm limit B For the minute volume MVe Upper alarm limit B and lower alarm limit D For end tidal CO2 concentration etCO2 if the CO2 sensor cable is connected Upp...

Страница 73: ...ured value 20 or 0 5 L min whichever is greater For RR high measured value 5 min with a minimum of 10 min The automatic alarm limits for etCO2 are based on the actual measured value for etCO2 as follows Lower alarm limit mmHg Current measured value mmHg Upper alarm limit mmHg Unchanged 15 Unchanged Measured value 5 15 to 35 Measured value 15 Measured value 7 35 to 45 Measured value 10 Measured val...

Страница 74: ...an be selected touch the X button in the top right hand corner of the ventilation dialog Alternatively Press the start dialog key on the control panel 2 To move to screen 2 of the dialog press button 1 in the top right hand corner of the screen 3 Touch the button System setup A In the configuration dialog the following information can be displayed and changed Screen brightness B 25 50 75 100 Breat...

Страница 75: ...d Disposable or Reusable 9 4 Setting the HME correction The temperature and moisture of the HME heat and moisture exchanger have an effect on the flow measurement The device can compensate for the presence of an HME To set the HME correction Touch the HME button set the desired value On or Off and confirm the setting 9 5 Setting the ventilation mode for the ventilation category Ventilation volume ...

Страница 76: ...ting an external device Operating systems that use Bluetooth may not all be compatible with one another 1 Activate the Bluetooth function on both devices 2 Start the connection from an external device coupling 3 In the external device enter the PIN displayed in the notification field of the ventilator The devices are then coupled automatically After the devices are coupled the ventilator automatic...

Страница 77: ...IBUS X Profile Definition for Data Communication V1 n 90 52 608 9 8 Activating the screenshot function option The screenshot function can be used to take a screenshot of every screen Screenshots are saved in the internal memory of the device To activate the screenshot function Touch the Screenshots Off button set to Screenshots On and confirm the setting A button to take a screenshot A appears in ...

Страница 78: ...he Advanced system setup button is grayed out The following screens are intended for service personnel and are password protected to prevent unauthorized adjustment For further information see the following chapter Password page 128 In the advanced system setup the following settings can be displayed and changed Language B Date C Time D Demo mode E On Off Export data F option Change password G Dev...

Страница 79: ...to save or cancel the date setting Day Month and Year must each be confirmed individually with the rotary knob Then all the settings must be confirmed with OK or can be discarded with Cancel 9 9 3 Time Here the system time of the device can be displayed and set Hours A Minutes B OK and Cancel C buttons to save or cancel the time setting Hours and Minutes must each be confirmed individually with th...

Страница 80: ... Export data button 2 Connect a USB flash drive The device automatically detects the USB flash drive and transfers the saved data to it A successful transfer is confirmed with the message Export successfully completed 3 Touch the Finish button to complete the export and remove the USB flash drive WARNING Risk of patient injury and damage to the device Do not connect a USB cable to the USB port The...

Страница 81: ...th the Password changed message If both entries of the new password were not identical the Password not changed error message is displayed 9 9 7 Device settings Here the system settings with which the device starts up can be specified The device settings are spread across two dialog pages On dialog page 1 2 the following device settings can be displayed and changed Breathing circuit A Disposable R...

Страница 82: ...ck Next and Finish D for navigating within the dialog 9 9 8 Ventilation settings Here the ventilation settings with which the device starts up can be specified WARNING Risk of patient injury When using several ventilators in the same environment of use the ventilation settings must be the same on all ventilators to prevent risk of patient injury Make sure that all ventilators have the same ventila...

Страница 83: ...endent on the selected ventilation category and the selected ventilation mode The sequence to access the preset values is always as follows 1 Select the patient category Adult or Child A 2 Select the ventilation category CPR Ventilation volume Ventilation pressure or CPAP B 3 Use Next C to navigate to the next dialog page 4 Select Ventilation volume VC CMV VC AC or VC SIMV PS option 5 Use Next C t...

Страница 84: ...0 O2 Adult CPAP SPN CPAP 5 30 O2 air mix Adult CPAP SPN CPAP PS 5 30 0 3 Me dium O2 air mix Adult CPR VC CMV 10 400 1 1 5 0 60 100 O2 Child Ventila tion volume VC CMV VC AC 20 200 1 1 5 5 25 0 100 O2 Child Ventila tion volume VC SIMV 20 200 1 2 5 25 0 3 Me dium 100 O2 Child Ventila tion pressure PC BIPAP 20 1 2 5 25 Pinsp 15 0 3 Me dium 100 O2 Child CPAP SPN CPAP 5 25 O2 air mix Child CPAP SPN CPA...

Страница 85: ...tten by the factory settings This cannot be undone To restore the factory settings Touch the Restore factory settings button and confirm Child MVe low MVe high 2 8 L min RR high 35 min etCO2 low etCO2 high 30 50 mmHg 4 0 6 7 kPa 4 0 6 7 Vol etCO2 low etCO2 high only CPR 0 99 mmHg 0 13 2 kPa 0 13 2 Vol Preset value for Value Alarm volume 75 Minimum alarm volume 25 Patient category Alarm limit Value...

Страница 86: ...creen 2 3 Touch the button Logbook A The logbook displays all events alarms and the switching off of the device in chronological order The most recent entry is at the top Earlier events and alarms can be displayed using the arrow keys A maximum of 400 logbook entries is visible When the capacity of the logbook is reached the oldest entries are overwritten For alarms the presence of an alarm condit...

Страница 87: ...s the start dialog key on the control panel 2 Touch button 1 in the upper right hand corner of the screen to go to screen 2 3 Touch the button System information A The system information is displayed in 2 columns in this screen Left hand column B Serial number Software version Device ID options and Date time Right hand column C Values for the parameters listed in the left hand column information a...

Страница 88: ...ies should be worked through in the order listed until the alarm has been resolved Some alarms appear in this table several times with different priorities because their priority may change under certain conditions 11 2 Messages in the alarm message field Alarm priority Exclamation marks Color High Red Medium Yellow Low Cyan Alarm prior ity Alarm Cause Remedy Inter nal pri ority Airway pres sure h...

Страница 89: ...led 7 Battery inspection due The scheduled service interval for the battery has expired Replace the battery Contact DrägerService 51 Battery low The device draws its power from the battery due to the absence of an external power sup ply There is only a duration of operation of approximately 15 minutes remaining in the battery The ventilator must immediately be con nected to the external power supp...

Страница 90: ... saved device settings Check the patient s condition Check the settings 46 CO2 calibra tion failed The sensor reports a calibration error Unplug the CO2 sen sor from the device and plug it back in 31 Perform the zero cali bration Perform the CO2 filter test CO2 cuvette soiled The sensor or the cuvette windows are soiled Clean the sensor and the cuvette windows or replace the cuvette 26 Perform the...

Страница 91: ... calibration of the CO2 sensor occurred Repeat the zero cali bration Do not breathe onto the CO2 sensor during the zero calibration 30 The sensor windows are soiled Clean the CO2 sensor windows The CO2 sensor has a hardware failure Replace the CO2 sen sor CO2 zero calibration required The zero point of the CO2 sensor is outside the tolerance range Perform the CO2 zero calibration and the CO2 filte...

Страница 92: ... perature Urgently move the device to a cooler envi ronment 3 etCO2 high The end tidal CO2 con centration is above the upper alarm limit Check the patient s condition 34 Check the alarm limits Adjust the alarm limit if necessary etCO2 low The end tidal CO2 con centration is below the lower alarm limit Check the patient s condition 35 Check the alarm limits Adjust the alarm limits if necessary Expi...

Страница 93: ...ratory pressure high The breathing valve or the breathing circuit is obstructed Check the patient s condition Check the breathing valve and the breath ing circuit 10 The expiratory resis tance is increased Check the bacteria filter or the HME filter and replace it if necessary Technical fault Disconnect the device from the patient and continue ventilation immediately using another ventilator Conta...

Страница 94: ...e VTi Eliminate leakage in the breathing circuit and or on the patient port Use a new breathing circuit 18 The flow sensor is faulty Replace the flow sen sor Technical fault Disconnect the device from the patient and continue ventilation immediately using another ventilator Contact DrägerService Loudspeaker faulty Technical fault To continue ventilation with this device contin uously monitor the d...

Страница 95: ...n with this device contin uously monitor the device functions Con tact DrägerService 43 Selection not confirmed The selection Standby or Shut down has not been confirmed with the rotary knob Check the setting If necessary repeat the selection and confirm it with the rotary knob 47 Service date reached The scheduled service date has been missed Contact DrägerService 52 Setting not confirmed The cha...

Страница 96: ...alue and confirm again with the rotary knob Pinsp PEEP 3 Pinsp or PEEP is changed Set Pinsp PEEP 3 mbar Pmax PEEP Psupp When adjusting PEEP or Psupp the upper limit Pmax is reached Select the settings so that the sum of PEEP and Psupp is below Pmax Pmax Pinsp Pmax or Pinsp is changed Set Pmax Pinsp RR too high check Ti The inspiratory and or expi ratory times resulting from the settings for RR and...

Страница 97: ...libra tion Do not breathe onto the CO2 sensor during the zero calibration Clean the CO2 test filter and the CO2 sensor Repeat the filter test A malfunction of the pneu matic components has occurred Contact DrägerService Test failed Check breathing circuit type The detected hose type does not match the selected hose type Select a different hose type Connect a different hose type Test failed Check b...

Страница 98: ...oving the breathing hose from the device Disassembling the CO2 sensor and the CO2 cuvette option 1 Unplug the CO2 sensor connector from the device 2 Remove the CO2 sensor B from the CO2 cuvette C 3 Remove the CO2 cuvette C from the flow or pressure sensor D 4 Remove the elbow A from the cuvette C Disassembling the reusable breathing circuit for adults 1 Disconnect the breathing hose from the devic...

Страница 99: ...nect the breathing hose from the device 2 Disconnect the flow measuring line or pressure measuring line from the device ports 3 Disconnect the flow sensor A from the breathing valve B 4 Carefully and evenly disconnect the flow measuring line or the pressure measuring line C from the flow sensor A CAUTION Damage to the device The flow sensor may be damaged when disconnecting the flow measuring line...

Страница 100: ...the rubber disk C in the housing Removing the disposable breathing circuit for adults 1 Disconnect the breathing hose from the device 2 Disconnect the pressure measuring line from the device 3 Correctly dispose of the complete disposable breathing circuit For further information see the following chapter Disposal page 109 Removing the disposable breathing circuit for adults Plus option 1 Disconnec...

Страница 101: ...g devices WARNING Risk of patient injury Disposable products have been developed tested and manufactured for single use only Disposable products must not be reused reprocessed or sterilized Reuse reprocessing or sterilization may lead to a failure of the accessory and may cause injury to the patient CAUTION Risk due to faulty products Signs of wear e g cracks deformation discoloration or peeling m...

Страница 102: ...fic components Non critical The entire device and all components that can be disas sembled e g the accessories bag CO2 sensor O2 hose Semi critical Breathing valve flow sensor pressure sensor breathing hose with measuring lines elbow CO2 cuvette Critical Components Product name Manufacturer Contact time Concentration Breathing valve hoses and pressure sensor Neodisher LM2 Dr Weigert 20 minutes 2 F...

Страница 103: ...ygen releasing agents and chlorine releasing agents may cause color change in some materials Color change does not indicate that the product is not functioning correctly Class of active ingredient Surface disinfectant Manufacturer Chlorine releasing agents Actichlor plus Ecolab BruTab 6S Brulin Clorox Professional Disin fecting Bleach Cleaner Clorox Dispatch Hospital Cleaner Disinfectant Towels wi...

Страница 104: ... Allow the product to dry 5 Check the product for visible soiling Repeat steps 1 to 5 if necessary 6 Check the product for visible damage and replace if necessary 12 7 Reprocessing list The instructions of the hospital s infection control officer shall prevail and must be observed by the user Components Surface disinfec tion with cleaning Manual cleaning followed by disinfec tion by immersion Mach...

Страница 105: ...in section Assembly and preparation on page 33 as a guide Check readiness for operation using the information in section Getting started on page 47 as a guide Accessories bag Yes No No No If soiled Carrying strap Yes No No No If soiled Components Surface disinfec tion with cleaning Manual cleaning followed by disinfec tion by immersion Machine cleaning with ther mal disin fection Steam steriliza t...

Страница 106: ...re WARNING Risk when the housing is being opened Under the housing there are live electrical components which may cause an electric shock The housing may only be opened by those target groups that are assigned to that particular measure 13 2 Definition of service terminology 13 3 Inspection Designation applies to the Federal Republic of Germany corresponds to the Recurring safety inspection in the...

Страница 107: ...re of the external power supply Check of the second alarm channel Monitoring of the supply pressure and the tightness of the compressed gas port with the standard connector Display of the high airway pressure alarm message Display of the breathing circuit error alarm message Check of the power supply displays 6 Perform the system test with the breathing circuit as described in the instructions for...

Страница 108: ...n The technical documentation which is available upon request contains additional information on Oxylog VE300 incl the service menu password 13 7 In the event of a device error or device malfunction WARNING Risk of patient injury Never operate a ventilator if it has suffered physical damage or seems to be working incorrectly In this case always have maintenance performed by specialized service per...

Страница 109: ...o Dräger s website is not possible contact the local Dräger organization 14 2 Disposal of the rechargeable battery WARNING Risk of explosion and of chemical burns Improper handling of batteries can result in explosions and chemical burns Do not throw batteries into fire or open them by force The medical device battery contains pollutant substances The following applies in the Federal Republic of G...

Страница 110: ...66 mm 23 9 x 9 0 9 9 x 6 5 in Power supply unit 150 x 37 x 64 mm 5 9 x 1 5 x 2 5 in DC DC converter 160 x 34 x 59 mm 6 3 x 1 3 x 2 3 in Main device without battery approx 3 3 kg 7 3 lb Main device with battery approx 3 6 kg 7 9 lb Main device with carrying sys tem with battery and bag approx 5 6 kg 12 4 lb Nominal weight with carrying sys tem battery bag 2 liter oxygen cylinder pressure reducer an...

Страница 111: ...ordance with IEC 60601 1 8 approx 47 to 83 dB A depending on alarm priority Complies with the standards IEC 60601 1 2 EN 794 3 36 101 10 V m ISO 10651 3 36 202 2 1 30 V m and UN Regulation No 10 revision 3 with respect to EMC for use in motor vehicles equivalent to European Commission Directive 2004 104 EC Complying with the industry standard RTCA DO 160G with respect to EMC for use in aircraft an...

Страница 112: ... pressure compensation within this pressure range Height above sea level up to 4000 m 13123 ft Ambient pressure power supply unit 700 to 1060 hPa 10 15 to 15 37 psi Relative humidity 5 to 95 without condensation Temperature 40 to 70 C 40 to 158 F Ambient pressure 620 to 1100 hPa 8 99 to 15 95 psi Relative humidity 5 to 95 without condensation Time required for the device tem perature to rise from ...

Страница 113: ...ion modes VC CMV VC AC SPN CPAP Optional VC SIMV PS PC BIPAP PS SPN CPAP PS Respiratory rate RR Adult 2 to 30 min VC SIMV PC BIPAP 5 to 30 min VC CMV VC AC Child 2 to 50 min VC SIMV PC BIPAP 10 to 50 min VC CMV VC AC Maximum airway pressure Pmax 20 to 60 mbar 20 to 60 cmH2O Ratio of inspiratory time to expiratory time I E 1 4 to 4 1 Inspiratory time Ti 0 3 to 10 s Tidal volume VT Adult 0 3 to 2 0 ...

Страница 114: ...t 6 mbar 6 cmH2O at 60 L min Child 4 mbar 4 cmH2O at 30 L min Inspiratory resistance during device failure Adult 6 mbar 6 cmH2O at 30 L min Child 4 mbar 4 cmH2O at 15 L min Expiratory resistance during device failure Adult 4 mbar 4 cmH2O at 30 L min Child 3 mbar 3 cmH2O at 15 L min Dead space including flow sensor but excluding accessories such as filter HMEs and CO2 cuvette approx 35 mL reusable ...

Страница 115: ...solution 1 mbar 1 cmH2O Accuracy 2 mbar 2 cmH2O 8 of measured value Flow measurement Minute volume MVe Display range 0 to 100 L min BTPS Resolution 0 1 L min Accuracy 20 of measured value or 0 4 L min whichever greater Tidal volume VTe Display range 0 to 5000 mL BTPS Resolution 1 mL Accuracy 20 of the measured value or 20 mL whichever greater adult breathing hose CO2 measurement option Measurement...

Страница 116: ...veform display Airway pressure Paw t 0 to 90 mbar 0 to 90 cmH2O Flow t 150 to 150 L min CO2 0 to 100 mmHg 0 to 15 Vol 0 to 15 kPa Expiratory minute volume MVe option Alarm upper alarm limit If the upper alarm limit has been exceeded Setting range 2 to 60 L min Alarm lower alarm limit If the value has fallen below the lower alarm limit Setting range 0 5 to 40 L min Alarm delay 40 seconds after the ...

Страница 117: ...nd calibration Alarm lower alarm limit If the value has fallen below the lower alarm limit Setting range 0 to 94 mmHg 0 to 12 7 kPa 0 to 12 7 Vol Alarm delay 30 seconds after the start of ventilation connec tion and calibration Leakage Alarm Only with Plus option in VC modes and deacti vated NIV in CPAP If VTe 45 of VTi Alarm delay 30 seconds after the start of ventilation Disconnection Alarm If a...

Страница 118: ...nd fully charged battery without external power supply 8 hours for typical ventilation VC CMV RR 12 min VT 500 mL PEEP 5 mbar 5 cmH2O I E 1 2 9 hours without CO2 sensor and at reduced screen brightness Power consumption During charging max 2 0 A at 19 VDC During typical ventilation max 0 8 A at 19 VDC Battery type Lithium ion battery Charging time Approx 5 hours The specified charging time applies...

Страница 119: ...ng capacity 1000 A 32 VDC Operating speed fast acting From a central gas supply system or an oxygen cylinder Oxygen supply pressure 270 to 690 kPa 39 16 to 100 08 psi Supply gas Medical oxygen oxygen 93 Connection to the oxygen supply either NIST Non Interchangeable Screw Threaded as per EN 739 ISO 5359 or DISS Diameter Index Safety Systems as per CGA V5 1989 or NF Norme franҫaise S90 116 Specific...

Страница 120: ...gm in breathing valve Silicone rubber Breathing hose Polyethylene PE Non return valve Polypropylene PP silicone rubber Breathing valve Polypropylene PP silicone rubber Housing of flow sensor Polymethyl methacrylate PMMA Vane in flow sensor Polyester Patient port Polyethylene PE Polypropylene PP K Resin Thermoplastic Polyether Elastomer TPE 33308 3 3 3 3 3 3 SLUDWRU YDOYH 6 3UHVVXUH VHQVRU 69 6DIHW...

Страница 121: ...evice may be damaged Only use the device in the direct vicinity of other devices if Dräger has approved this device arrangement If no approval has been given by Dräger ensure that this device functions correctly in the desired arrangement before use Observe the other devices instructions for use 15 11 2 Electromagnetic environment This device may only be used in environments specified in section E...

Страница 122: ...Operation is subject to the following 2 conditions 1 This medical device does not cause any harmful interference 2 The medical device will not suffer damage when receiving interference including interference causing undesired operating conditions Changes or modifications that are not expressly approved by Dräger may void the user s authority to operate the device Dräger hereby declares that this m...

Страница 123: ... network that incorporates other devices or making subsequent changes to that network can lead to new risks for patients users and third parties Before the device is connected to the network or the network is changed these risks must be identified analyzed and evaluated and appropriate measures taken Examples of subsequent changes to the network Changing the network configuration Removing devices ...

Страница 124: ...er devices that use software may use open source software depending on their setup Open source software may be subject to different terms of license Additional information regarding the open source software used in this device is available at the following web page www draeger com opensource ...

Страница 125: ...em holder 57 90 231 Adapter Weinmann LIFE BASE 57 90 471 Adapter all round wall holder 57 90 472 Lithium ion battery 57 90 224 DC DC converter 57 04 799 Power supply unit 57 90 808 Battery charger 57 90 223 Power supply unit holder for standard rail MC 00 155 Power cable Germany 18 24 481 Denmark 18 68 950 United Kingdom 18 44 369 Australia 18 51 705 Switzerland 18 44 377 USA 18 41 793 China 18 59...

Страница 126: ...atient use size M MP 01 574 NIV face mask ClassicStar SE single patient use size L MP 01 575 NIV face mask NovaStar SE reusable size S MP 01 579 NIV face mask NovaStar SE reusable size M MP 01 580 NIV face mask NovaStar SE reusable size L MP 01 581 Breathing hose sets and accessories Breathing hose with 1 measuring line reusable 1 5 m MP 01 390 Breathing hose with 1 measuring line reusable 3 0 m M...

Страница 127: ...pressure measurement reusable MP 01 372 Flow sensor reusable Plus option 84 12 034 Elbow reusable with and without Plus option 84 12 235 Breathing valve reusable with and without Plus option 84 12 001 Test lung 84 03 201 Dräger USB flash drive 84 16 347 Part name Order number ...

Страница 128: ... any changes here For additional information on the service menu see page 108 WARNING Unauthorized access to the system setup If the password is not changed unauthorized individuals have access to the system setup and can change important settings Change the preset password before the ventilator is used for the first time For further information see the following chapter Changing the password page...

Страница 129: ...Instructions for use Oxylog VE300 SW 1 n 129 This page has been left blank intentionally ...

Страница 130: ...ssembly 98 Disposal 109 Reprocessing 104 Setting 75 Breathing circuits Overview 21 C Carrying system Assembly 34 Technical data 110 Views 20 Catheter mount Connecting 45 CO2 cuvette Connecting 45 Disassembling 98 Disposal 109 Reprocessing 104 Setting 76 CO2 sensor Connecting 45 Disassembling 98 Reprocessing 104 Color concept Dark green 32 Gray 32 Yellow 32 Connected devices Safety instructions 12 ...

Страница 131: ...y instruction 11 O O2 air mix 48 84 Overview 66 Open source software 124 Oxygen Safety instructions 13 Oxygen cylinder Requirements 33 Safety instructions 13 Oxygen fittings Safety instructions 13 P Password 108 128 Performance characteristics 9 Pneumatic diagram 120 Precautionary statements 10 Product labels Safety instruction 11 Protection bar variants 33 R Repair 108 Reprocessing Classification...

Страница 132: ...6 Operating data 118 Performance data 114 Safety information 110 Settings 113 Technical documentation 108 Trademarks 6 V Ventilation mode Changing 63 Preparing 55 Selecting 56 Setting for Ventilation category 75 Ventilation modes Overview 23 Ventilation parameter Presettings 84 View Carrying system bottom 21 Carrying system right side 20 Main device front 19 Main device rear 18 Main device upper s...

Страница 133: ...Instructions for use Oxylog VE300 SW 1 n 133 This page has been left blank intentionally ...

Страница 134: ...rning medical devices Directive 1999 5 EC on radio and telecommunication equipment Manufacturer Drägerwerk AG Co KGaA Moislinger Allee 53 55 23542 Lübeck Germany 49 451 8 82 0 FAX 49 451 8 82 2080 http www draeger com 9054926 GA 5503 350 en Drägerwerk AG Co KGaA Edition 5 2017 12 Dräger reserves the right to make modifications to the device without prior notice ...

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