Dräger D-Vapor Instructions For Use Manual Download Page 89

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Instructions for use D-Vapor/D-Vapor 3000

Cleaning and disinfection

Cleaning and disinfection

Safety information for reprocessing

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Reprocessing procedures

. . . . . . . . . . . . . . . 91

Classification of medical devices . . . . . . . . . . . 91
Testing of procedures and agents . . . . . . . . . . 91
Manual disinfection and simultaneous
cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 91
Visual inspection. . . . . . . . . . . . . . . . . . . . . . . . 92

Before reusing on the patient

. . . . . . . . . . . . 92

Summary of Contents for D-Vapor

Page 1: ...Instructions for use D Vapor D Vapor 3000 Anesthetic agent vaporizer WARNING To properly use this medical device read and comply with these instructions for use ...

Page 2: ...ndicate the listing of data options or objects A Letters in parentheses refer to elements in the related illustration A Letters in illustrations denote elements referred to in the text Trademark Trademark owner D Vapor Dräger Selectatec Datex Ohmeda Suprane Baxter International Inc SAFE FILTM Baxter International Inc TORRANETM Safeline Pharmaceuticals Piramal FillTM Piramal Trademark Trademark own...

Page 3: ... may only perform the following tasks if they meet the corresponding requirements Users Service personnel Specialized service personnel Dräger recommends arranging a service contract with DrägerService Task Requirement Use of the product in ac cordance with the in tended use Specialist medical knowledge in anesthe sia Task Requirement Installation Specialist knowledge in electrical engineering and...

Page 4: ...4 Instructions for use D Vapor D Vapor 3000 Abbreviations and Symbols For explanations refer to sections Abbreviations and Symbols in the System overview chapter ...

Page 5: ... and self test 62 Adjusting concentration of anesthetic agent 63 Changing the anesthetic agent 64 Ending delivery of anesthetic agent 65 Operation during mains power failure battery operation 65 Operational interruptions 66 Disconnecting the vaporizer 67 Transport when filled 68 End of operation draining the vaporizer 69 Blowing off the vaporizer 71 Storage 72 Dispatch 72 Alarms 73 Alarm concept 7...

Page 6: ...Calibration 109 Influence of temperature 109 Influence of flow 110 Influence of gas type and composition 111 Influence of atmospheric pressure and altitude 111 Correction of the flow measurement under the influence of desflurane 112 List of accessories 113 Quality Inspection Certificate 115 Index 117 ...

Page 7: ... use 8 Service 8 Safety checks 8 Accessories 9 Connected devices 9 Not for use in areas of explosion hazard 9 Safe connection with other electrical equipment 9 Patient safety 10 Patient monitoring 10 Storing the instructions for use 10 Information on electromagnetic compatibility 10 Product specific safety information 11 Essential performance 12 Additional safety information for D Vapor 3000 13 ...

Page 8: ...nstructions for use This medi cal device may only be used for the purpose specified under Intended use on page 16 Strictly observe all WARNING and CAUTION statements throughout these instructions for use and all statements on medical device la bels Failure to observe these safety information statements constitutes a use of the medical device that is inconsistent with its intended use WARNING Risk ...

Page 9: ...rrent list of accessories WARNING Risk of electric shock and of device malfunc tion Any connected devices or device combina tions not complying with the requirements mentioned in these Instructions for Use may compromise the correct functioning of the medical device Before operating the medical device strictly comply with the instructions for use of all connected devices or device combinations WAR...

Page 10: ...e variety of means ranging from electronic surveillance of medical device performance and patient condition to simple direct observation of clinical signs The responsibility for selecting the best level of patient monitoring lies solely with the user of the medical device Storing the instructions for use Information on electromagnetic compatibility General information on electromagnetic compatibil...

Page 11: ...has been dropped Check the vaporizer that has toppled over see Checking operational readiness page 54 If the check is not possible do not use the va porizer WARNING Risk of patient injury Incorrect concentrations of anesthetic agent can harm the patient Use continuous monitoring of the delivered concentrations of anesthetic agent as per ISO 21647 or ISO 80601 2 55 standard with upper and lower ala...

Page 12: ... indicated vol ume is too high High frequency ventilation or the use of anes thesia machines with discontinuous fresh gas flow or repeated use of the O2 flush can cause the vaporizer to switch off Observe the instructions for use for the anes thesia machine WARNING Risk of patient injury Device functions can be manipulated or switched off via the RS232 interface The available RS232 interface must ...

Page 13: ...rizer WARNING Risk of patient injury The transfer of data to the anesthesia worksta tion can be erroneous The indication of the filling level on the screen of an anesthesia workstation with the Vapor View option is provided only for infor mation Only rely on the filling level shown on the va porizer WARNING Risk of patient injury The transfer of data to the anesthesia worksta tion can be erroneous...

Page 14: ...14 Instructions for use D Vapor D Vapor 3000 This page has been left blank intentionally ...

Page 15: ...Instructions for use D Vapor D Vapor 3000 15 Use Use Intended use 16 Environment of use 16 ...

Page 16: ...ent of use D Vapor D Vapor 3000 is intended for operation with anesthesia workstations in hospitals and rooms used for medical purposes Restrictions to the working area D Vapor D Vapor 3000 is not suitable for operation in rooms used for magnetic resonance imaging Installation and or operation with anesthesia workstations in moving vehicles airplanes helicopters or ships is not permitted If there ...

Page 17: ...ystem overview Comparison D Vapor with D Vapor 3000 18 What is new with the D Vapor 3000 design 18 What is new with the D Vapor 3000 functionality 18 Overview of functions 19 D Vapor 20 Front 20 Rear 21 D Vapor 3000 22 Front 22 Rear 23 Abbreviations 24 Symbols 25 ...

Page 18: ...s displayed on the anesthesia workstation screen The recognized active vaporizer type is displayed on the anesthesia workstation screen Vapor View functions are only available for the D Vapor 3000 anesthetic vaporizer and cannot be fitted to the D Vapor anesthetic vaporizer D Vapor D Vapor 3000 Anesthetic agent Desflurane DES Desflurane DES Connection and Interlock system Plug in adapter DW 2000 w...

Page 19: ...en the fresh gas metering unit and the fresh gas outlet Functional integrity of the vaporizer is dependent on the direction of flow The vaporizer must be connected and operated in accordance with the direction of flow specified on the device The use of the vaporizer with different anesthesia workstations is therefore only permissible and safe when it is used with the appropriate special adapter Si...

Page 20: ...illing level F Display panel G Button for suppressing the acoustic alarm for 2 minutes H Protective cap for equipotential equalization pin I Indication of anesthetic agent and vaporizer model J Indication of concentration units K 0 button for locking the control dial in the 0 or T position Display panel A Yellow LED Audio paused 2 min B Green LED Operational C Red LED No Output D Red LED Delivery ...

Page 21: ...ustration showing Interlock 2 C Slot for locking lever so that the vaporizer can only be removed from the anesthesia workstation when the control dial is in the T position D Connection system Shown Plug in adapter DW 2000 E Cover for RS232 interface F Power cable G Rating plate indicating manufacturer model and serial number 002 A B D E C F G ...

Page 22: ...panel G Button for suppressing the acoustic alarm for 2 minutes H Protective cap for equipotential equalization pin I Indication of anesthetic agent and vaporizer model J Indication of concentration units K Window to allow light to exit for illumination L 0 button for locking the control dial in the 0 or T position Display panel A Yellow LED Audio paused 2 min B Green LED Operational C Red LED No ...

Page 23: ...m the anesthesia workstation when the control dial is in the T position D Window for reading Vapor View data E Connection system for the Auto Exclusion plug in adapter D Vapor 3000 is only available with this plug in adapter F Cover for RS232 interface G Power cable H Rating plate indicating manufacturer model and serial number I Window to allow light to enter in order to illuminate the control di...

Page 24: ...nit of mass kPa Kilopascal unit of pressure lbs Pound unit of mass m Meter unit of length MAC Minimum Alveolar Concentration mL Milliliter unit of volume mm Millimeter unit of length MRI Magnetic resonance imaging MV Minute volume N2O Medical nitrous oxide NMD Narkomed name for anesthesia machine from Draeger Inc USA formerly North American Dräger O2 Medical oxygen Pa Pascal 1 mbar 100 Pa or 1 hPa...

Page 25: ...tion 0 zero set ting see page 30 Control dial position T transport setting see page 30 D DES D Vapor Des DES D Vapor 3000 On control dial Abbreviation of the anesthetic agent for which the vaporizer is specified and calibrated min Minimum permissible filling lev el on the sight glass max Maximum permissible filling lev el on the sight glass Operating Instructions Read Instructions Caution 12 14 16...

Page 26: ...26 Instructions for use D Vapor D Vapor 3000 This page has been left blank intentionally ...

Page 27: ...off 30 Control dial position T transport setting 30 Connection and Interlock systems for D Vapor 31 Plug in adapter plug in connector 31 Plug in adapter DW 2000 with Interlock 2 32 Dräger Auto Exclusion plug in adapter 32 Plug in adapter S 2000 with Interlock S 33 Permanent connection 34 ISO conical adapter 34 Connection and Interlock systems for D Vapor 3000 34 Filling systems 35 Baxter SAFE FIL ...

Page 28: ...scribed in the chapter Alarm cases on page 78 Vaporizer off The vaporizer power cable is not connected to the power supply All LEDs A B C D E are off Self test The power cable is connected to the power supply All LEDs A B C D and E light A short tone sounds at the start and end of the self test Vaporizer warming up The power cable is connected to the power supply The vaporizer is warming up The op...

Page 29: ...the T position transport setting the control dial is locked and can only be adjusted by keeping the 0 button pressed All illustrations of a vaporizer on an anesthesia workstation show a stylized anesthesia workstation in the background All illustrations of the T position transport setting only show the disconnected vaporizer itself Control dial position ON switching on and adjusting the concentrat...

Page 30: ...cted to the parking holder 1 Press the 0 button A 2 Turn the control dial B clockwise to the T position the 0 key engages 3 Engage the locking lever C on the plug in adapter in the control dial NOTE Concentration values greater than 12 Vol are shown in inverted form in order to draw attention to the danger of a high output concentration and re stricted flow range The concentration range above 12 V...

Page 31: ... Cicero 1 When connecting or disconnecting the vaporizer the control dial must be at the T position A and the locking lever B must be engaged in the control dial 2 The holes in the plug in adapter C on the vaporizer fit onto the pins on the plug in connector D on the anesthesia workstation 3 To secure or release swing the locking lever B into position and engage or disengage the pin in the control...

Page 32: ...ger Auto Exclusion plug in adapter The Dräger Auto Exclusion plug in adapter is connected to Dräger Auto Exclusion plug in connectors or to Dräger plug in connectors Anesthesia workstations with Auto Exclusion plug in connectors Auto Exclusion plug in connectors are designed only for vaporizers with Auto Exclusion plug in adapters and are marked with the following symbol on the anesthesia workstat...

Page 33: ...2000 plug in adapter with Interlock S is connected to Selectatec compatible plug in connectors For anesthesia workstations with several plug in connectors combined with Interlock S When a vaporizer is switched on two pins on the side of the relevant plug in adapter are pushed out These pins prevent other vaporizers on adjacent plug in connectors from being switched on Illustration left vaporizer b...

Page 34: ...tral vaporizer operational right and left vaporizers blocked Other Interlock systems are also used such as Interlock 1 which are very similar to Interlock NMD but which do not need to fit vaporizers with Interlock NMD ISO conical adapter The ISO conical adapter is used for anesthesia workstations with 23 mm 0 91 in conical connectors conforming to ISO 5356 1 A Male adapter cone on the vaporizer in...

Page 35: ...for desflurane Suprane The Baxter SAFE FIL filling system consists of the following components A Filling opening B Sealing plug C Unlocking button D Anesthetic agent bottle with filling adapter for desflurane Suprane Piramal Fill filling system for desflurane Torrane The Piramal Fill filling system for desflurane Torrane consists of the following components A Filling port with the Desflurane Piram...

Page 36: ...0 mL in the tank At the very latest the vaporizer should be filled when the minimum mark is reached Bubble formation in the sight glass When withdrawing desflurane at a high rate high concentration set and or high fresh gas flow vapor bubbles can appear in the sight glass This has no effect on the functioning of the vaporizer If the concentration and or the fresh gas flow is set lower the bubbles ...

Page 37: ... in adapter 41 Filling the Vaporizer 42 Safety information concerning filling the vaporizer 42 Vaporizer states for filling 43 Vaporizer with Baxter SAFE FIL filling system for desflurane Suprane 44 Vaporizer with Piramal Fill filling system for desflurane Torrane 46 Connecting the vaporizer 48 Vaporizer with plug in adapter 48 Anesthesia workstations with several plug in connectors 48 Positioning...

Page 38: ...ower cable connected by maintenance personnel Fitting the battery 1 Unscrew the baseplate A using a 2 5 mm 0 1 in screwdriver B 2 Connect the battery cable C 3 Insert the battery D in the battery compartment WARNING Risk of patient injury If the battery is not present or is damaged the secondary alarm system will not be available Furthermore emergency operation may be partially or completely unava...

Page 39: ...iness see page 54 5 Check the concentration see page 57 Fitting the connectors Always connect the vaporizer in such a way that the gas flows as shown in the diagram and matches the arrow on the rear of the vaporizer Observe instructions for use of the anesthesia workstation 017 B C A WARNING Risk of incorrect output concentration or es cape of anesthetic agent Connectors may only be fitted by spec...

Page 40: ...tween the plug in adapter and the vaporizer Do not use fan locking washers plain washers or similar 3 Before fastening check that the sealing surfaces are clean and undamaged 4 Place the sealing rings B part no M 21929 on the sealing areas around the gas passages 5 Tighten screws to a torque of 270 to 300 Ncm once do not tighten any more 6 Check that the connector is secure Connecting to a Titus a...

Page 41: ... are not correctly positioned loss of fresh gas leaks or low concentrations of anesthetic agent may result The plug in adapter must sit evenly and hori zontally on the seals WARNING Risk of a malfunction The following plug in adapters are designed solely for connection to Dräger plug in con nectors D Vapor with plug in adapter DW 2000 and plug in adapter Auto Exclusion D Vapor 3000 with plug in ad...

Page 42: ...rd Take care not to spill anesthetic agent Do not inhale anesthetic agent vapors WARNING Observe the safety data sheet from the anes thetic agent manufacturer Adhere to the spec ified protective measures Desflurane blue WARNING Risk of explosion when used with flammable substances The vaporizer is not approved or certified for use with flammable or explosive anesthetic agents e g ether or cyclopro...

Page 43: ...ed in the T position B WARNING Risk of patient injury Filling during battery operation shortens the battery operating time Never fill the vaporizer models D Vapor and D Vapor 3000 during battery operation WARNING Risk of patient injury Watch the filling level in the sight glass Fill the vaporizer to the maximum mark only When the filling level is below the minimum mark the vaporizer must be refill...

Page 44: ...ll flow into the vaporizer The contents of the bottle will show bubbles 6 Watch the filling level in the sight glass When the maximum mark is reached the flow stops automatically 7 If the Vaporizer is filled when it is warmed up the contents of the tank will also bubble Briefly interrupt the filling to check the fill level To do this stop pressing down the anesthetic agent bottle Then press the bo...

Page 45: ... withdraw the anesthetic agent bottle from the filling opening 4 Check the filling level in the sight glass The vaporizer must be hanging or standing vertically during the check The filling level must be visible and must not be above the maximum mark 5 Insert the sealing plug into the filling opening and press it down until the lock engages audibly 6 Close the anesthetic agent bottle with the cap ...

Page 46: ...nector Oth erwise the Vaporizer will not be filled Do not use excessive force WARNING Danger to the user The valve pin in the filling device must only be actuated by the Piramal desflurane bottle Do not use any other object to depress the valve pin Otherwise desflurane may spurt WARNING Spraying of anesthetic agent If the bottle is not properly inserted into the filling port the thread may jam and...

Page 47: ...re 1 Slowly turn the anesthetic agent bottle B counterclockwise The spring in the integrated closure C ensures that the bottle valve closes and prevents loss of anesthetic agent The filling procedure is completed 2 Continue to slowly turn the anesthetic agent bottle and withdraw it from the filling port 3 Check the filling level in the sight glass The vaporizer must be hanging or standing vertical...

Page 48: ... Before connecting the vaporizer move the latch of the Interlock 2 A to the opposite position If a vaporizer has already been connected and is in operation the vaporizer must first be set to the 0 position WARNING Risk of patient injury Too high a fresh gas inlet pressure can result in a pressure monitoring error and thus to un derdosing The maximum fresh gas inlet pres sure must not exceed 200 kP...

Page 49: ...occur remove the vaporizer see page 67 check the lever position and the engaging mechanism then reconnect the vaporizer 2 Swing the locking lever B clockwise by 90 until it engages The vaporizer is then secured and cannot be removed 3 Press the 0 button and set the control dial to the 0 C position WARNING Risk of patient injury A malfunction in the Interlock system can en danger the patient by ove...

Page 50: ... 125 A4 washers 5 Connect the gas inlet line and outlet line D to the vaporizer 6 Press the 0 button E and set the control dial to the 0 position 029 WARNING Risk of patient injury Risk of incorrect output concentration and high resistance may affect breathing The vaporizer is not suitable for use in a breathing system A B A C 030 WARNING Risk of patient injury The wrong flow direction will result...

Page 51: ...dapters Never connect the vaporizers in series 031 0 0 0 0 A B B A 032 WARNING Danger to the patient from overdosing and or mixing anesthetic agents Without the Interlock system there is a danger that several vaporizers will be switched on and operational at the same time If this happens gas containing anesthetic agent would flow from one vaporizer into the next vaporizer resulting in uncontrolled...

Page 52: ...qualization bonding conductor to the equipotential equalization pin B 3 Connect the other end of the potential equalization conductor to a central equipotential equalization pin WARNING Health hazard Do not use mains plugs or power cables that are damaged There is a risk of electric shock otherwise WARNING Health hazard Only connect the medical device to a mains power supply with a protective grou...

Page 53: ...nesthetic agent 63 Changing the anesthetic agent 64 If only one vaporizer is connected or if one of the connected vaporizers is to be replaced 64 Two vaporizers with Interlock 2 64 Ending delivery of anesthetic agent 65 Operation during mains power failure battery operation 65 Operational interruptions 66 Vaporizer remains on device 66 If the vaporizer is disconnected or transported 66 Disconnecti...

Page 54: ...intact and functioning 1 Control dial cap sits firmly on the control dial 2 Control dial engages both in the 0 position and in the T position and cannot be turned without the 0 button being pressed 3 After the 0 button is pressed the control dial can be turned as far as the end position near the 12 marking After the 0 button is pressed again the control dial can be turned as far as the end positio...

Page 55: ...the D Vapor 1 Drop in pin A on locking lever secure and straight 2 Both valve control pins B present 3 Transverse pin C at the bottom of the locking lever is tight in the center and not bent 4 Sealing surfaces D undamaged DrägerAuto Exclusion plug in adapter D Vapor D Vapor 3000 1 Drop in pin A on locking lever secure and straight 2 Both valve control pins B present 3 Transverse pin C at the botto...

Page 56: ...ion D Vapor only Vaporizer fixed securely to connector Filling systems Baxter SAFE FIL filling system for desflurane Suprane and Piramal Fill filling system for desflurane Torrane Discoloration and contamination of the anesthetic agent If there is contamination shown by discoloration have the vaporizer repaired by specialized service personnel Concentration check Check the delivered concentration ...

Page 57: ...rking twice Check the marking from the direction of a lower concentration and from the direction of a higher concentration 2 Set the control dial 3 Let the vaporizer dose for 1 to 2 minutes 4 Take reading of measured value once it has stabilized Correcting measured values Correcting the units used on the anesthetic agent monitor If the display on the monitor is Determining the permissible range Re...

Page 58: ...desflurane vaporizer at the 8 setting The measured value is 8 58 Vol Monitor display is in Vol therefore no correction According to the chapter Technical Data the permissible range of the vaporizer is 15 of the set value i e 6 8 to 9 2 Vol The technical data for the anesthetic agent monitor lists an accuracy of 5 rel For a measured value of 8 58 Vol this results in a tolerance of 0 43 Vol The perm...

Page 59: ...er is operated at an angle of more than 10 uncontrolled concentrations may oc cur Do not operate the vaporizer when it is at an incline of more than 10 WARNING Health hazard Connections and plug in connectors adapters can leak at greater tilt angles The filling level shown in the sight glass will not be correct when the vaporizer is used at an angle This may result in overfilling Do not operate th...

Page 60: ...anging vertically on machine when viewed from front and side and cannot be lifted off Other connectors Vaporizer connected firmly and securely on anesthesia workstation Vaporizer is hanging or standing upright and is secured against tilting or falling Direction of flow corresponds to arrow on vaporizer If there are several connectors check connector allocation and Interlock 1 All connectors alloca...

Page 61: ... dial setting 2 Vol 10 Flush the breathing system with fresh gas before connecting a patient WARNING A malfunction in the Interlock system can en danger the patient by overdosing or mixing anesthetic agents The tabs in the two openings in the control dial cap on the Interlock 2 must be undam aged See also the chapter Checking opera tional readiness on page 54 for more infor mation On the Interlock...

Page 62: ...ked and the desired concentration set Alarm cases If the control dial is operated while the green Operational LED is flashing an alarm tone sounds and the red No Output LED B flashes No anesthetic agent will be dispensed If the green Operational LED is still flashing after 20 minutes warm up contact specialized service personnel see Alarm cases on page 78 If the yellow Fill Up LED C is lit fill th...

Page 63: ...ration cannot be set Do not force the control dial Check that all other vaporizers connected are in the 0 or the OFF position and that Interlock it is functional 2 Check the filling level in the sight glass C regularly The filling level must be visible between the minimum and maximum marks 3 When the refill mark D has been reached up to 240 mL of desflurane may be refilled using an anesthetic agen...

Page 64: ... it engages 2 On the vaporizer to be used press the 0 button and set the control dial B to the concentration of anesthetic agent required WARNING Concentration too low If the underdosing alarm occurs Correct the setting see Influence of flow on page 110 If the alarm continues Observe the anesthetic gas measurements on the monitor Set control dial to the 0 po sition Disconnect the mains power suppl...

Page 65: ...nutes at a maximum dosing rate of 6 Vol and a fresh gas flow of 4 L min Approx 30 seconds after the mains power supply failure a medium priority alarm will be generated The yellow Battery LED flashes and a suppressible alarm tone sounds If the mains power failure ends before 5 minutes have elapsed the vaporizer reverts to mains operation The vaporizer switches off after a maximum of 5 minutes batt...

Page 66: ...ration draining the vaporizer on page 69 Observe the use by date and storage conditions for the anesthetic agent Vaporizer remains on device Disconnect the vaporizer from the mains power supply Locking lever on the plug in adapter should remain locked off Keep within the permissible temperature range see page 100 If the vaporizer is disconnected or transported Disconnecting the vaporizer see page ...

Page 67: ...nd engage it in control dial 3 The vaporizer can now be lifted off C the plug in connector smoothly using both hands WARNING Risk of injury and of damaging the vaporizer The vaporizer can fall over Disconnect the mains plug before removing the vaporizer WARNING Risk of injury and of damaging the vaporizer Take care not to drop the vaporizer Do not use the vaporizer if it has been dropped Damage ma...

Page 68: ...ble vaporizers from the anesthesia workstation and transport individually The anesthesia workstation may be moved with the vaporizer switched on Anesthesia workstations with securely fastened vaporizers Anesthesia workstations with securely fastened vaporizers may be moved within or between buildings with the control dial set at 0 or T if there is no risk of tilting by more than 10 Notes on transp...

Page 69: ... withdraw the sealing plug B from the filling opening 2 Take an undamaged anesthetic agent bottle provided by Baxter for desflurane Suprane Unscrew the cap 3 Insert the anesthetic agent bottle C into the filling port The anesthetic agent bottle will engage in the filling opening with an audible clicking sound 4 Turn the vaporizer upside down until the anesthetic agent bottle is hanging vertically ...

Page 70: ...g the draining 1 Insert the sealing plug into the filling opening and press it down until the lock engages audibly 2 Close the anesthetic agent bottle with the cap 3 Mark the bottle Used anesthetic agent Recommendation Do not reuse Vaporizer with filling device for the Piramal Fill filling system for desflurane Torrane Draining the vaporizer Use an undamaged anesthetic agent bottle provided by Pir...

Page 71: ...the procedure with an empty anesthetic agent bottle Ending the draining 1 Place the screw cap A in the filling port and screw it all the way in 2 Close the anesthetic agent bottle with the cap 3 Mark the bottle Used anesthetic agent Recommendation Do not reuse Blowing off the vaporizer If the anesthetic agent remaining in the tank also has to be removed after complete draining 1 Connect the vapori...

Page 72: ...g packaging with at least 5 cm 2 in of impact resistant material around each vaporizer Fasten the packaging securely WARNING Internal damage to the vaporizer and incorrect output concentrations Internal damage to the vaporizer may occur if the storage temperature range is exceeded Observe the storage temperatures see page 100 Do not use the vaporizer otherwise Have in spection carried out NOTE Bef...

Page 73: ...Instructions for use D Vapor D Vapor 3000 73 Alarms Alarms Alarm concept 74 Alarm priorities and alarm signals 74 Optical alarm signals 74 Secondary audible alarm system 75 Suppressing the alarm tone 75 ...

Page 74: ...No Output C Red LED Delivery Low D Yellow LED Fill Up E Yellow LED Battery List of the causes and remedies for an alarm see Alarm cases page 78 Warning Alarm with high priority Immediate action re quired to avert an acute hazard Red LED flashes quickly Two tone sequences with 5 tones each every 9 seconds Caution Alarm with medi um priority Prompt action re quired to avert an acute hazard Yellow LE...

Page 75: ...ivated by one of the following actions The cause of the fault is resolved The control dial is set to the 0 position Lists of the causes and remedies for a fault see chapter Problem solving page 77 Press the Audio paused 2 min key A Alarm Cause Remedy Continuous tone 7 s Mains supply failure no further battery operation possible Turn control dial to the 0 position Change to a vaporizer that does no...

Page 76: ...76 Instructions for use D Vapor D Vapor 3000 This page has been left blank intentionally ...

Page 77: ...por 3000 77 Problem solving Problem solving Problems 78 Alarm cases 78 Other faults 81 Filling and draining vaporizer 84 Plug in adapter problems 85 Problems with D Vapor 3000 on the anesthesia workstation with the Vapor View option 87 ...

Page 78: ...ng Equipment fault Take equipment out of ser vice Set control dial to the 0 position Disconnect the mains power supply Re move the vaporizer from the anesthesia workstation if possible Repair by specialized ser vice personnel Warning Green Operational LED flashes Red No Output LED flash es Dosing request during warm up phase Malfunction Set control dial to the 0 po sition Wait until the green Oper...

Page 79: ...etic agent observe warm up time if necessary Caution Green Operational LED flashes Yellow Battery LED flash es Mains power failure Battery operation vaporiz er continues to dose see Operation during mains power failure battery oper ation page 65 Prepare for change of an esthetic agent Note Start and end of self test are indicated by a short tone All LEDs must light during the self test If one or m...

Page 80: ... control dial to posi tion 0 or T If the yellow Battery LED is still lit after 1 hour the bat tery is defective Have the battery replaced by service personnel see page 38 Repair by specialized ser vice personnel Note Yellow Fill Up LED is lit The level is below the refill mark A full bottle of desflurane anesthetic agent can be added see Filling the Va porizer page 42 Priority Alarm indication Cau...

Page 81: ...gh the va porizer in the wrong direction Check the connection system see page 39 Leak e g plug in adapter is not sitting completely on seals Disconnect vapor check plug in adapter safety locking device and sealing rings replace Per form tightness check of the va porizer at control dial settings 0 and 2 Vol D Vapor only Leakage at connector e g va porizer connected to Titus which has not been conve...

Page 82: ...ic agent or an esthetic agent mixture in the va porizer Check the vaporizer drain and blow off see page 69 and 71 Have the vaporizer repaired by specialized service personnel Monitor has not yet switched over after a change of anesthet ic agent Wait until the monitor switches over Monitor defective Replace monitor Control dial cannot be set to concentration 0 button not pressed Press the 0 button ...

Page 83: ... after the filling proce dure Before removing the anesthetic agent bottle from the filling opening wait until the anesthet ic agent has drained into the tank See Ending the filling pro cedure on page 45 Filling level cannot be read in sight glass Vaporizer completely empty Refill the vaporizer Vaporizer overfilled Drain the vaporizer to the maxi mum marking Check the con centration Sight glass dis...

Page 84: ...porizer accidentally filled with incorrect anesthetic agent Drain the vaporizer see page 69 and blow it off see page 71 Have the vaporiz er repaired by specialized ser vice personnel Anesthetic agent leaks from fill ing system Seal on anesthetic agent bottle damaged or defective Use another anesthetic agent bottle ...

Page 85: ...rewdriver The vaporizer can now be dis connected Repair by specialized service personnel Plug in adapter not fitting flush on plug in connector seals Leak in unit Locking lever not engaged in control dial as it is set at 0 or 2 Vol Set control dial to T and engage insert pin on locking lever into slot on control dial and engage Engagement mechanism on plug in adapter or plug in con nector damaged ...

Page 86: ...not be turned Interlock pins are not in their original position If adjacent vaporizers have been removed Check whether control dial can be turned Squeeze both Interlock pins in wards by hand one after the other and release If this does not correct the problem Repair by specialized service person nel Fault Cause Remedy ...

Page 87: ...irty or covered with foreign objects Clean window for light to exit re move foreign bodies Control dial position is not trans ferred or transferred incorrectly Viewing window partly covered in dirt Clean viewing window Camera system in the anesthe sia workstation defective Contact specialized service per sonnel Anesthetic agent type is not transferred Viewing window partly covered in dirt Clean vi...

Page 88: ...88 Instructions for use D Vapor D Vapor 3000 This page has been left blank intentionally ...

Page 89: ...on Cleaning and disinfection Safety information for reprocessing 90 Reprocessing procedures 91 Classification of medical devices 91 Testing of procedures and agents 91 Manual disinfection and simultaneous cleaning 91 Visual inspection 92 Before reusing on the patient 92 ...

Page 90: ...d may harm the patient If liquids other than the anesthetic agents specified get into the vaporizer this can cause malfunctions of the vaporizer and harm to the patient Do not immerse the vaporizer in cleaning agents Detergents must not be allowed to get under the control dial Do not allow detergents to get into the gas in lets or gas outlets or the filling system Do not sterilize the vaporizer Do...

Page 91: ...sinfection of medical products has been tested with the following procedures and agents At the time of testing the following agents exhibited good material compatibility Buraton 10F made by Schülke Mayr basic active ingredient aldehyde Dismozon pur made by Bode Chemie basic active ingredient oxygen releasing agent Manual disinfection and simultaneous cleaning Dräger recommends using a surface disi...

Page 92: ...wear e g cracking embrittlement or pronounced hardening and residual soiling Before reusing on the patient Prepare the vaporizer see page 37 Checking operational readiness see page 54 Quaternary ammonium com pounds Mikrozid sensitive liquid1 Schülke Mayr Mikrozid sensitive wipes1 Aldehydes Buraton 10 F Schülke Mayr 1 Virucidal against enveloped viruses Class of active ingredient Product name Manuf...

Page 93: ...Instructions for use D Vapor D Vapor 3000 93 Service Service Overview 94 Definition of service terms 94 Inspection 95 Safety checks 95 Maintenance 96 Repair 96 Wearing parts 96 ...

Page 94: ...ue to wear or material fatigue of the components To maintain the proper operation of all compo nents this device must undergo inspection at intervals specified by the manufacturer WARNING Risk of patient injury The patient is put at risk if maintenance is per formed during ventilation Perform maintenance only when no patient is connected to the device Concept Definition Service All measures inspec...

Page 95: ...ing to IEC 62353 device leakage current 50 A or IEC 60601 normal condition NC 50 A SFC 100 A Check emergency power operation Battery charged for 1 hour the vaporizer must dose for 5 minutes in battery operation at a flow rate of 4 L min and control dial position 6 Vol Check of leak tightness with vaporizer switched off and control dial positions 0 and 18 Vol Test pressure 350 hPa 357 cmH2O Test va...

Page 96: ...äger recommends DrägerService and only the use of authentic Dräger parts Wearing parts The following wear parts must be replaced if any non conformities with the specified values are found during inspection and servicing or during routine checks by the user Wear part Personnel responsible Note Filter gas inlet Specialized service personnel Mounting screw Specialized service personnel Replacement a...

Page 97: ...Instructions for use D Vapor D Vapor 3000 97 Disposal Disposal Disposing of the medical device 98 Battery disposal 98 ...

Page 98: ...e end of its service life Completely empty the vaporizer before disposal see page 69 Blow off the vaporizer see page 71 Clean and disinfect the vaporizer see page 89 Observe the applicable laws and regulations Battery disposal The medical device battery contains pollutant substances The following applies for Germany According to the Battery Ordinance the end user is obliged to return batteries con...

Page 99: ... characteristics 100 Pneumatic interfaces 102 Monitoring 103 Electrical characteristics 103 Standards 104 Dimensions 104 D Vapor 104 D Vapor 3000 104 Weight D Vapor D Vapor 3000 105 EMC Declaration 105 General information 105 Electromagnetic environment 105 Recommended separation distances from wireless communication devices 106 ...

Page 100: ...ensing During storage and transport Temperature 20 to 60 C 4 to 140 F Atmospheric pressure 115 to 1100 hPa 1 7 to 16 psi Relative humidity 5 to 95 non condensing Performance characteristics The D Vapor is calibrated at a temperature of 22 C 71 6 F and an atmospheric pressure of 1013 mbar 14 7 psi Carrier gas Air flow 2 5 L min Concentration range 2 to 18 Vol Scale 2 to 10 Vol 1 Vol divisions 10 to...

Page 101: ...ers are calibrated by the manufacturer within the following tolerances under the previous ly noted calibration conditions 0 5 Vol or 15 rel The larger value applies Outside of the calibration conditions the following applies at 0 2 to 2 L min fresh gas flow 0 9 Vol or 30 rel The larger value applies at 2 to 8 L min fresh gas flow 0 9 Vol or 20 rel The larger value applies at 8 to 15 L min fresh ga...

Page 102: ... fill level of the vaporizer Bridging time when mains power supply absent maximum of 5 minutes at a concentration of 6 Vol maximum fresh gas flow 4 L min and fully charged battery Noise emission during operation 45 dB A Pneumatic interfaces Filling systems Baxter SAFE FIL filling system for desflurane Su prane Piramal Fill filling system for desflurane Torrane Connections D Vapor DW 2000 Auto Excl...

Page 103: ...ce with ISO 3744 Sound pressure at least 60 dB Alarm tone sequence High priority alarms Two tone sequences with 5 tones each every 9 seconds Medium priority alarms One tone sequence with 3 tones every 24 seconds Signal for note short tone Electrical characteristics Supply voltage 100 V to 240 V Supply frequency 50 60 Hz Current consumption 2 A Inrush current 25 A Power consumption maximum 530 W du...

Page 104: ...ISO 80601 2 13 IEC 60601 1 IEC 60601 1 8 Electromagnetic compatibility IEC 60601 1 2 Filling systems Baxter SAFE FIL filling system for desflurane Suprane and Piramal Fill filling system for desflurane Torrane ISO 5360 23 mm conical connector 0 9 in conical connec tor ISO 5356 1 067 Depth 248 mm 9 8 inch Width 110 mm 4 3 inch Height 248 mm 9 8 inch 0 Width Depth Height 068 Depth 248 mm 9 8 inch Wi...

Page 105: ...evices only if Dräger has approved this device arrangement If no approval has been given by Dräger it must be ensured that this device functions correctly in the desired arrangement before use The instructions for use for the other devices must be followed Electromagnetic environment This device may only be used in environments specified in section Environment of use on page 16 Connector Weight in...

Page 106: ... Immunity against Test level and required electromagnetic envi ronment Electrostatic discharge ESD IEC 61000 4 2 Contact discharge 6 kV Air discharge 8 kV Fast transient electrical disturbances bursts IEC 61000 4 4 Power cables 2 kV Longer signal input lines output lines 1 kV Impulse voltages surges IEC 61000 4 5 Voltage external conductor external conductor 1 kV Voltage external conductor protect...

Page 107: ...r switched off 109 Control dial setting 2 Vol vaporizer switched on 109 D Vapor 3000 109 Calibration 109 Influence of temperature 109 Influence of flow 110 Influence of gas type and composition 111 Influence of atmospheric pressure and altitude 111 Correction of the flow measurement under the influence of desflurane 112 ...

Page 108: ...ed vapor via the proportional valve J to ensure that the pressure drop across the two gaps bypass and metering gap is always equally large The desflurane concentration is determined by the ratio of the resistances of the fixed bypass gap and the metering gap This ratio is set by the control dial K The regulated tank heater provides a constant temperature 40 C 104 F and consequently a constant adeq...

Page 109: ...a workstations that also have the Vapor View option the D Vapor 3000 anesthetic vaporizer is illuminated in the area of the control dial and sight glass Therefore the concentrations set and the filling level are also visible in darkened rooms Additionally the position of the control dial is transmitted to the anesthesia workstation as a setting value Calibration Each vaporizer is set individually ...

Page 110: ... see Technical Data page 101 In the area of the dashed lines B with a simultaneously high flow rate and high concentration the vaporizer meters less than the value set on the control dial See Technical Data page 101 The diagram shows the typical influence of flow on the concentration delivered at 22 C 71 6 F 1013 hPa 14 69 psi when operating with Air 045 0 4 8 12 16 20 0 2 4 6 8 10 12 14 18 16 14 ...

Page 111: ... to Air falls by a maximum of 10 relative Influence of atmospheric pressure and altitude The D Vapor is calibrated in Vol The calibration in Vol is independent of the ambient pressure The partial pressure of the delivered desflurane vapor determines the physiological effect The partial pressure is dependent on the ambient pressure The required setting is calculated according to the formula The fol...

Page 112: ...n the desflurane concentration is high See instructions for use for the monitor used Correcting values for the minute volume MV Correcting values for tidal volume VT Example Desflurane concentration 8 Vol Displayed minute volume MV 10 L min MVcorrected Displayed MV x 100 2 x desflu rane concentration 100 VTcorrected Displayed VT x 100 2 x desflu rane concentration 100 MVcorrected 10 x 100 2 x 8 10...

Page 113: ...ower cable 2 IEC plugs Extension 1856928 D Vapor D Vapor 3000 Power cable IEC IEC length 0 75 m 29 5 in 1860925 Grounding cable length 3 2 m 10 5 ft 8301349 O ring for plug in system 2 pcs required U04314 O ring for sealing plug Baxter SAFE FIL filling system for desflurane Suprane MK03818 O ring for screw cap Piramal Fill filling system for desflurane Torrane M35964 Internal battery M35526 Parkin...

Page 114: ...114 Instructions for use D Vapor D Vapor 3000 This page has been left blank intentionally ...

Page 115: ... adjusted in the factory to within the tolerances specified in the following table under calibration conditions temperature 22 C 71 6 F atmospheric pressure 1013 hPa 14 69 psi continuous flow 2 5 L min Air without ventilation pressure without pressure fluctuations and without back pressure Precise measuring instruments are used for the individual adjustment to the desflurane anesthetic agent The c...

Page 116: ...116 Instructions for use D Vapor D Vapor 3000 This page has been left blank intentionally ...

Page 117: ...Dispatch 72 Display panel 20 22 Disposal 98 Disposing of anesthetic agent 69 Dräger Auto Exclusion plug in adapter 32 49 55 Draining 69 F Fastening 40 Fault Cause Remedy 78 Filling 42 44 Filling level 20 22 45 Filling systems Baxter 35 44 69 Piramal 35 46 70 Fitting the connectors 39 Flow dependence 110 Fresh gas flow 65 Functional description 108 G Gas composition 101 Gas connection seal 40 H Haz...

Page 118: ...1 67 seal 48 Preparation 57 Problem solving 77 R Repair 8 96 Reprocessing procedures 91 S Safety checks 95 Secondary audible alarm system 75 Selectatec 33 49 Serial Number 21 23 Service 8 93 94 Setting 57 Shut down 69 71 Sight glass 36 Sight glass see Filling level 20 22 Storage 72 Suppressing the alarm tone 75 Switching off 30 Switching on 29 Symbols 25 T Tank 71 Technical data 99 Technical docum...

Page 119: ...Instructions for use D Vapor D Vapor 3000 119 This page has been left blank intentionally ...

Page 120: ...evice or unit These instructions for use will only be updated or exchanged on customer request Directive 93 42 EEC concerning Medical Devices Manufacturer Drägerwerk AG Co KGaA Moislinger Allee 53 55 D 23542 Lübeck Germany 49 451 8 82 0 FAX 49 451 8 82 20 80 http www draeger com 9037890 GA 5328 400 en Drägerwerk AG Co KGaA Edition 15 2020 02 Edition 1 2004 04 Dräger reserves the right to make modi...

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