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Instructions for use Dräger-Vapor 2000 Dräger-Vapor 3000 Anesthetic vaporizer WARNING To properly use this medical device, read and comply with these instruc- tions for use.
Typographical conventions Use of terms 1 Consecutive numbers indicate steps of action, with the numbering restarting with "1" for each Dräger uses the term "accessory" not only for ac- new sequence of actions. cessories in the sense of IEC60601-1, but also for ...
Safety Information Definitions WARNING A WARNING statement provides important in- formation about a potentially hazardous situa- tion which, if not avoided, could result in death or serious injury. CAUTION A CAUTION statement provides important infor- mation about a potentially hazardous situation which, if not avoided, may result in minor or mod- erate injury to the user or patient or in damage to the medical device or other property.
Service personnel Specialized service personnel Task Requirement Task Requirement Installation Specialist knowledge in Installation Specialist knowledge in electrical engineering electrical engineering Basic service activities Basic and complex and mechanics and mechanics (inspection, service activities maintenance according (inspection, Experience in the Experience in the to the "Maintenance"...
Contents Contents For Your Safety and that of Your Patients . . Transport when filled ....92 End of operation – Draining the vaporizer..93 General safety information .
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Contents List of accessories ..... 157 Quality Inspection Certificate ... . 159 Index .
For Your Safety and that of Your Patients For Your Safety and that of Your Patients General safety information ....Strictly follow these instructions for use ..Service .
For Your Safety and that of Your Patients General safety information Service The following WARNING and CAUTION state- ments apply to general operation of the medical de- vice. WARNING WARNING and CAUTION statements specific to Risk of medical device failure and of patient subsystems or particular features of the medical injury device appear in the respective sections of these...
For Your Safety and that of Your Patients Accessories Patient monitoring The user of the medical device is responsible for WARNING choosing suitable monitoring that provides appro- Risk due to incompatible accessories priate information about medical device perfor- mance and the patient's condition. Dräger has tested only the compatibility of ac- cessories listed in the current list of accesso- Patient safety may be achieved by a wide variety of...
For Your Safety and that of Your Patients Product-specific safety information WARNING WARNING Risk of device errors Not permitted modifications Various potentially dangerous situations can Modifications to the medical device that are arise that require the attentiveness of users. not permitted may result in malfunctions. Only use the device under the permanent su- This medical device must not be modified pervision of users in order to provide a...
For Your Safety and that of Your Patients Essential performance WARNING Risk of patient injury The essential performance of the anesthetic vapor- Deviation of the delivered concentration due izers Vapor 2000 and Vapor 3000 consists in the to filling the vaporizer with incorrect anes- controlled enrichment of medical fresh gas with an- thetic agent.
For Your Safety and that of Your Patients Additional safety information for WARNING Vapor 3000 Risk of patient injury The transfer of data to the anesthesia worksta- WARNING tion can be erroneous. Risk of patient injury and user injury The indication of the detected, active vapor- Vapor 3000 is not tested for use in magnetic izer type on the screen of an anesthesia work- fields.
Application Intended use Vapor 2000/Vapor 3000 is an unheated, calibrated anesthetic vaporizer for the enrichment of dry, fresh medical gas in anesthesia workstations with pre- cisely controlled concentrations of vapor from liquid anesthetic agents. Environments of Use Vapor 2000/Vapor 3000 is intended for operation in anesthesia workstations in hospitals and rooms used for medical purposes.
System overview System overview Comparison Vapor 2000 with Vapor 3000 . . 16 What is new with the Vapor 3000 design ..16 What is new with the Vapor 3000 functionality......16 Overview of functions .
System overview Comparison Vapor 2000 with Vapor 3000 Vapor 2000 Vapor 3000 Anesthetic agent Halothane (H or HAL) Enflurane (E or ENF) Isoflurane (I or ISO) Isoflurane (Iso. or ISO) Sevoflurane (S or SEV) Sevoflurane (Sev. or SEV) Connection and Inter- Plug-in adapter DW-2000 with Interlock 2 lock system Dräger Auto Exclusion plug-in adapter...
System overview – When the refill marker is reached, a filling level Vapor View functions are only available for the message is displayed on the anesthesia work- Vapor 3000 anesthetic vaporizer and cannot be fit- station screen. ted to the Vapor 2000 anesthetic vaporizer. –...
System overview Vapor 2000 Front G Sight glass for displaying the filling level H Indication of anesthetic agent and vaporizer model Indication of concentration units J 0 button for locking the control dial in the 0 or T position A Control dial cap with color coding of the anes- thestic agent and with Interlock code B Control dial with concentration markers and code letter for the anesthetic agent...
System overview Rear A Locking lever of plug-in adapter B Opening for Interlock locking device (illustrated: Interlock 2) C Slot for locking lever, so that the vaporizer can only be removed from the anesthesia worksta- tion when the control dial is in the T position D Rating plate indicating manufacturer, model, and serial number E Connector system...
System overview Vapor 3000 Front G Covering cap H Sight glass for displaying the filling level 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 A Control dial cap with color coding of the anes- thestic agent and with Interlock code...
System overview Rear G Window to allow light to get out to illuminate the control dial and the sight glass A Locking lever of plug-in adapter B Opening for Interlock locking device (illustrated: Interlock 2) C Notch for locking lever, so that the vaporizer can only be removed from the anesthesia worksta- tion when the control dial is in the T position D Window to read off Vapor View data...
System overview Abbreviations Abbreviation Description Abbreviation Description Percentage partial pressure of an- Magnetic Resonance Imaging, esthetic agent in fresh gas at va- writing on Dräger fill adapters that porizer outlet. Unit of output con- are not ferromagnetic centration, see "Calibration" Magnetic resonance imaging on page 143.
System overview Symbols Symbol Description Symbol Description Warning! Strictly follow the in- Vol.% Volume percent, indicates con- structions for use. centration unit Observe the instructions for use Vol. Volume min. Minimum permissible filling Operating Instructions level on the sight glass Caution! Observe accompany- max.
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This page was intentionally left blank. Instructions for use Dräger-Vapor 2000/Dräger-Vapor 3000...
Operating Concept Control dial Control dial position ON – Switching on The operation of the control dial is identical for Vapor 2000 and Vapor 3000. and adjusting the concentration The vaporizer is switched on and off and the con- Only adjust the concentration when the vaporizer is centration of the anesthetic agent is adjusted by connected to an anesthesia workstation.
Operating Concept Control dial position 0 – Switching off Control dial position T – Transport set- ting Always set the control dial to the 0 position when the vaporizer is connected to an anesthesia work- Always set the control dial to the T position when station but no anesthetic agent is to be adminis- the vaporizer is being disconnected from the anes- tered.
Operating Concept Connection and Interlock systems for Vapor 2000 Different connecting systems are available for op- Most plug-in connectors have valves through which erating the Vapor 2000 anesthetic vaporizer in an- fresh gas can flow even if the vaporizer is not con- esthesia workstations.
Operating Concept DW-2000 plug-in adapter with Interlock 2 Plug-in adapter Dräger Auto Exclusion The Dräger Auto Exclusion plug-in adapter is con- nected to Dräger Auto Exclusion plug-in connec- tors or to Dräger plug-in connectors. NOTE The Dräger Auto Exclusion plug-in adapter is compatible with the DW-2000 plug-in connector.
Operating Concept Illustration: left vaporizer blocked, right vaporizer operational. Illustration: left vaporizer blocked, right vaporizer operational. Permanent connection S-2000 plug-in adapter with Interlock S For permanent installation in the fresh-gas line for anesthesia workstations, with the appropriate con- The S-2000 plug-in adapter with Interlock S is con- nector options.
Operating Concept ISO conical adapter The ISO conical adapter is used for anesthesia workstations with 23 mm (0.91 in) conical connec- tors conforming to ISO 5356-1. Illustration: central 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 a vaporizer with A Male adapter cone on the vaporizer inlet...
Operating Concept Filling systems for Vapor 2000 The filling system is used for filling the vaporizer The Dräger Fill filling system consists of the follow- with the specified anesthetic agent and draining. ing components: The filling system has a sight glass with minimum A the anesthetic agent-specific filling device on and maximum levels marked and a third (middle) the vaporizer...
Operating Concept Quik Fil filling system with screw-on adapter Safety filling system The Quik Fil filling system consists of the following components: A the anesthetic agent-specific filling device on the vaporizer B the anesthetic agent-specific Quik Fil filling adapter screwed on to the bottle C the anesthetic agent-specific collar and threads on the neck of the bottle Piramal Fill filling system...
Operating Concept Funnel filling system Safe-T-Seal filling system NOTE The funnel filling system does not comply with the anesthetic agent-specific filling system require- ments of ISO 80601-2-13. Safe-T-Seal filling system with permanently mounted adapter The Safe-T-Seal filling system consists of the fol- lowing components: The funnel filling system consists of the following components:...
Operating Concept Filling systems for Vapor 3000 Vapor 3000 is only available with the following fill- – Safe-T-Seal filling system, see "Safe-T-Seal fill- ing systems: ing system" on page 34 – Dräger Fill filling system, see "Dräger Fill filling The fill cap of the filling device has a bayonet fitting. system"...
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This page was intentionally left blank. Instructions for use Dräger-Vapor 2000/Dräger-Vapor 3000...
Preparation Preparation Fitting the connectors ....38 Fitting the plug-in adapter or the ISO conical adapter (Vapor 2000 only) ....38 Before first use .
Preparation Fitting the connectors Fitting the plug-in adapter or the WARNING ISO conical adapter (Vapor 2000 only) Risk of incorrect output concentration or es- cape of anesthetic agent 1 Remove protecting cap on gas inlet/gas outlet Connectors may only be fitted by specialized at the back, if fitted.
Preparation 5 Tighten screws to a torque of 270 to 300 Ncm WARNING once, do not tighten any more. Risk of injury. Risk of incorrect output concen- 6 Check that the connector is secure. tration If these requirements are not met, the vapor- izer might loosen and fall off.
Preparation Vaporizers must only be used with anesthesia WARNING workstations that conform to: Risk of a malfunction – IEC 60601-2-13 The following plug-in adapters are designed – ISO 80601-2-13 solely for connection to Dräger plug-in con- nectors. – ISO 8835-4 –...
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Preparation Observe the manufacturer's regulations regarding NOTE the correct use and storage of the anesthetic agent, Vaporizers that are supplied by a pharmaceutical particularly the regulations concerning the correct company and are identified accordingly are in- temperature range. tended for use only with the anesthetic agent from that company.
Preparation Vapor 2000/Vapor 3000 with Dräger Fill CAUTION filling device Health hazard Significant quantities of anesthetic agent may es- Observe the warning notices from page 40 on- cape. wards. Make sure that the drainage valve is closed be- fore the vaporizer is filled. Vaporizer connected to the anesthesia worksta- tion WARNING...
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Preparation Vaporizer not connected to the anesthesia 2 Select the Dräger Fill filling adapter for the par- workstation ticular anesthetic agent. The color code and designation/symbols on the filling adapter must correspond to the anesthetic agent used. 3 Unscrew the screw cap (D) from the anesthetic agent bottle.
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Preparation Vapor 3000: WARNING – Turn the sealing cap a 1/4 turn to the left and Health hazard. Delivery of incorrect concen- take it off. tration 6 Insert the anesthetic agent bottle with filling If the connection between the filling adapter adapter (G) into the filling opening.
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Preparation 1 Reduce the pressure on the anesthetic agent CAUTION bottle (K) and withdraw it slowly. Health hazard 2 Check the filling level in the sight glass (L). The A bottle which is dropped may release significant vaporizer must be hanging or standing verti- quantities of anesthetic agent.
Preparation Vapor 2000/Vapor 3000 with Quik Fil fill- NOTE ing device Check the vaporizer for leaks each time before use, see "Checklist – Checks before each use" Observe the warning notices from page 40 on- on page 82. wards. Leaks in the filling device can only be detected when checking in control dial position 0.2 Vol.%.
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Preparation Vaporizer not connected to the anesthesia WARNING workstation Risk of patient injury If new and/or sealed anesthetic agent bottles are partly empty, there may be a leak. The vaporizer can be overfilled and anesthetic agent vapor and anesthetic agent fluid could then escape.
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Preparation 1 Only use anesthetic agent bottles with an anes- thetic agent-specific collar (E) on the neck of the bottle. WARNING Risk of incorrect filling Substance-specific filling cannot be assured if bottles without a collar are used. Only use anesthetic agent bottles with an an- esthetic agent-specific collar on the neck of the bottle.
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Preparation Vapor 2000: 7 Push the bottle (J) all the way to the end stop in – Unscrew the sealing cap. the filling opening and hold it there; keep a good grip on the bottle. Avoid using excessive – Turn the sealing cap a 1/4 turn to the left and force and tilting the bottle.
Preparation 1 Reduce the pressure on the anesthetic agent NOTE bottle (M) and withdraw it slowly. Check the vaporizer for leaks each time before use, see "Checklist – Checks before each use" 2 Check the filling level in the sight glass (N). The on page 82.
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Preparation Engage control dial in the 0 (A) position. WARNING Risk of patient injury CAUTION If new and/or sealed anesthetic agent bottles Health hazard are partly empty, there may be a leak. Fresh gas and anesthetic agent vapor can es- The vaporizer can be overfilled and anesthetic cape.
Preparation NOTE CAUTION Inadvertent tilting while screwing on the sealing Health hazard cap can cause the filling device to leak. If the vaporizer is filled above the maximum mark To prevent this, after fitting the cap first turn it by a few millimeters, the anesthetic agent will start counterclockwise until the threads engage audi- to flow out through an overflow hole (G).
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Preparation 1 Only use anesthetic agent bottles with an anes- CAUTION thetic agent-specific collar (C) on the neck of Health hazard the bottle. Fresh gas and anesthetic agent vapor can es- WARNING cape. Risk of incorrect filling If the vaporizer is being filled during operation, it is necessary to wait at least 5 seconds after set- Substance-specific filling cannot be assured if ting the control dial to the 0 position before open-...
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Preparation WARNING Risk of patient injury If new and/or sealed anesthetic agent bottles are partly empty, there may be a leak. The vaporizer can be overfilled and anesthetic agent vapor and anesthetic agent fluid could then escape. Observe the sight glass; fill the vaporizer no higher than the maximum mark.
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Preparation Ending the filling procedure WARNING Risk of patient injury Use of excessive force can damage the seal and the lever mechanism and fresh gas and anesthetic agent vapor may escape. 1 Swing the anesthetic agent bottle (M) down. 2 Check the filling level in the sight glass (N). The vaporizer must be hanging or standing verti- cally during the check.
Preparation Vapor 2000 with funnel filling system WARNING Risk of patient injury NOTE If the lever is not correctly locked, fresh gas The funnel filling system does not comply with the and anesthetic agent vapor could escape after anesthetic agent-specific filling system require- the machine is switched on or tilted.
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Preparation Vaporizer not connected to the anesthesia 1 Unscrew the screw cap (C) from the anesthetic workstation agent bottle. 2 Slowly unscrew the sealing cap (D) on the fill- ing device so that any pressure present in the vaporizer can escape slowly. 3 Pour anesthetic agent slowly into the inner fill- ing funnel (E), keeping a firm grip on the bot- tle.
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Preparation Ending the filling procedure NOTE Inadvertent tilting while screwing on the sealing cap can cause the filling device to leak. To prevent this, after fitting the cap first turn it counterclockwise until the threads engage audi- bly and perceptibly (1/2 turn max.). Then screw on the sealing cap, free of tilt, in a clockwise di- rection (1 to 1.5 turns).
Preparation Vapor 2000/Vapor 3000 with Safe-T-Seal Vaporizer not connected to the anesthesia workstation filling device Observe the warning notices from page 40 on- wards. Vaporizer connected to the anesthesia worksta- tion Control dial remains engaged at the 0 position. Filling during operation Control dial remains engaged at the T position (B).
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Preparation 1 Only use anesthetic agent bottles with an anes- WARNING thetic agent-specific collar (E) on the neck of the Risk of patient injury bottle. If new and/or sealed anesthetic agent bottles WARNING are partly empty, there may be a leak. Risk of incorrect filling The vaporizer can be overfilled and anesthetic agent vapor and anesthetic agent fluid could...
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Preparation Vapor 2000: – Unscrew the sealing cap. – Turn the sealing cap a 1/4 turn to the left and take it off. Vapor 3000: – Turn the sealing cap a 1/4 turn to the left and take it off. 6 Insert the bottle with the filling adapter (G) in the filling opening (I).
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Preparation 7 Push the bottle (J) all the way to the end stop in 1 Reduce the pressure on the anesthetic agent the filling opening and hold it there; keep a bottle (M) and withdraw it slowly. good grip on the bottle. Avoid using excessive 2 Check the filling level in the sight glass (N).
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Preparation NOTE Check the vaporizer for leaks each time before use, see "Checklist – Checks before each use" on page 82. Leaks in the filling device can only be detected when checking in control dial position 0.2 Vol.%. 4 Screw the cap (P) on to the Safe-T-Seal filling adapter.
Preparation Connecting the vaporizer Control dial must be engaged in the T position. 2 The sealing ring on each pin of the plug-in con- If not: nector (B) must be undamaged. There should Check the concentration before operation, see be no foreign objects on the plug-in connector.
Preparation Several Selectatec-compatible plug-in connec- Positioning the vaporizer on the plug-in tors connector 1 Switch off vaporizers on other plug-in connec- tors. Set control dial to the 0 position. 2 When several vaporizers are connected, they must always be directly next to each other. Direct contact on the side Interlock pins is required for the Interlock system to operate.
Preparation 1 Insert the vaporizer in the fresh-gas line. 2 On anesthesia workstations with rigid conical connectors, adjustment plates (A) may be used for alignment: – Between the connecting piece and the con- necting plate and/or the connecting plate and the anesthesia workstation. –...
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Preparation Use of several vaporizers with ISO conical CAUTION adapters Risk of injury and of damaging the vaporizer A free-standing vaporizer must be secured against tilting and falling. WARNING Mixtures, or concentrations that are too high may be delivered. Make sure that only one vaporizer can be used at any one time or that only one vaporizer is ...
Preparation Operation in magnetic fields (Vapor 2000 only) Due to its pneumatic principle of operation and low WARNING ferromagnetic content, Vapor 2000 can generally Danger to the patient. Health hazard be used in magnetic fields, i.e., in connection with magnetic resonance tomographs (MRI) and in con- Before being used in magnetic fields for the junction with anesthesia workstations suitable for first time, the equipment combination of va-...
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Preparation Checks before each use" on page 82, in order to WARNING ensure that the vaporizer is correctly fastened, se- Risk of injury curely connected and free from leaks. Unsuitable filling adapters can be attracted by WARNING the magnetic field. Risk of injury to the patients Use only suitable adapters for filling and emp- tying the vaporizer: Dräger Fill filling adapters...
Preparation Operation on ships (Vapor 2000 only) The Vapor 2000 has been tested for use on ships – Rolling of the ship can cause incorrect output in accordance with the standards "MIL-STD 810F" concentrations due to swashing of the liquid an- and "BV0240", Table 6/II, "Vibration safety for ships esthetic agent in the vaporizer chamber or leaks of the German navy".
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Preparation – The pitch of the ship must not exceed 20°. At WARNING greater pitching angles, remove the vaporizer Risk of injury from the anesthesia workstation with the control dial in the T position and pack it securely to pre- An insufficient supply of oxygen can harm the vent tipping, falling, and damage.
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This page was intentionally left blank. Instructions for use Dräger-Vapor 2000/Dräger-Vapor 3000...
Operation Operation Checking that the unit is ready for use ..74 Vaporizer with Quik Fil filling device (Vapor 2000/Vapor 3000) ....95 Plug-in adapter DW-2000, Vapor 2000 with the Piramal Fill filling Dräger Auto Exclusion and S-2000 .
Operation Checking that the unit is ready for use The readiness for use must be checked: Interlock intact and functioning – after care and maintenance of the anesthesia workstation or the vaporizer – after an extended operational interruption, after 12 months at the latest General condition of the vaporizer ...
Operation Plug-in adapter DW-2000, Dräger Auto Exclusion and S-2000 Vaporizer not connected to the plug-in connec- Turn locking lever to locking position – it must turn back automatically. Re-engage locking lever in control dial. 1 Drop-in pin (A) on locking lever secure and straight.
Operation 4 Sealing surfaces (D) undamaged. 6 Attachment plate (F) on the back of the vapor- izer present and secure. 5 Cover plate (E) present and undamaged. 6 Auto Exclusion transmission pin (F) present, movable and cannot be removed. ISO conical adapter (Vapor 2000 only) 7 Bearing pin (G) present, tight and flush with ...
Operation 2 Anesthetic agent in sight glass is not discolored. Concentration check Vapor 2000 only WARNING Halothane: Risk of patient injury Halothane, for example, contains thymol, which is less volatile than Halothane. Thymol and Incorrect concentrations of anesthetic agent other reaction products may gradually accumu- can harm the patient.
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Operation 5 Connect anesthetic agent monitor to vaporizer Correcting measured values outlet, fresh-gas outlet, or Y-piece. Make sure Correcting the units used on the monitor that the connections are leak-tight. If the display on the monitor is 6 Make sure that the pressure drop from the va- porizer outlet to the monitor is less than 10 hPa in % partial pressure: No correction (10.2 cmH...
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Operation Table 1: Marking Correction [% p <0.6 No correction 0.6 to 1.0 –0.05 1.5 to 2.0 –0.10 2.5 to 3.0 –0.15 3.5 to 4.0 –0.20 5.0 to 8.0 –0.30 At greater altitudes above 500 m (1640 ft) and at- mospheric pressure <950 hPa (13.8 psi), a correc- tion with respect to the dependence of the vapor- izer on atmospheric pressure and altitude is...
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Operation – Test with oxygen: Correct measured values (in ) according to Table 3 below. Interpolation between the values in the table is possible. Table 3: Correction of measured values with respect to dependence on pressure at 2.5 L/min oxygen, 22 °C (71.6 °F) Atmospheric 1013...
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Operation Example of a concentration test at sea level Example of a concentration test at an altitude of with an atmospheric pressure of 1013 hPa 2000 m (6562 ft) with an atmospheric pressure (14.7 psi) of 800 hPa (11.6 psi) Test of an Isoflurane vaporizer at the 3 % set- Test of an Isoflurane vaporizer at the 6 % set- ting...
Operation Putting into operation Checklist – Checks before each use The following checks must be carried out each time WARNING before operation: Danger to the patient. Health hazard For operation in magnetic fields, use only the Conditions equipment combinations of vaporizer, anes- 1 Operating parameters (e.g.
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Operation monitor switched on. Alarm limits set. WARNING 8 When using a CO attachment (CO module) Health hazard for dosing CO on the anesthesia workstation, Connections and plug-in connectors/adapters may be conducted through by the vapor- can leak at greater tilt angles. The filling level izer.
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Operation Checking the connector system 3 Only one vaporizer connected at a time. If not: Plug-in connector: Check that there is an Interlock system on Plug-in adapter sits evenly on the seals. Lock- the vaporizer and anesthesia workstation, ing lever swung to the left.
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Operation 8 Switch off the vaporizer – Control dial engaged at the 0 position. 9 Check that the vaporizer, connector, and fresh- gas lines are leak-tight (see the instructions for use of the anesthesia workstation): – at control dial settings 0 and T –...
Operation Adjusting concentration of anesthetic agent WARNING WARNING Risk of patient injury, risk of underdosage Risk of patient injury, risk of overdosage During initial use or after extended storage or If, when in control dial position T, the vapor- repair, the wicks inside the vaporizer will be izer is heated up due to a high ambient tem- dry.
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Operation 4 When the refill mark (D) is reached, the vapor- izer may be refilled with 260 mL (normal anes- thetic agent bottle). 5 Fill the vaporizer at the latest when the mini- mum mark (E) is reached, see page 40. WARNING Risk of patient injury If the anesthetic agent monitor shows implau-...
Operation Changing the anesthetic agent Two vaporizers with Interlock 2 Set the vaporizer being used to the 0 position. If only one vaporizer is connected or if one of the connected vaporizers is to be replaced 1 Disconnect the vaporizer, see page 90. 2 Connect the new vaporizer, see page 64.
Operation Ending delivery of anesthetic agent Then, if required: Switch off fresh-gas flow on the anesthesia workstation. WARNING The fresh-gas flow must never be switched off before the vaporizer is switched off. The va- porizer must never be left switched on without a fresh-gas flow.
Operation Disconnecting the vaporizer Plug-in connector WARNING Risk of injury and of damaging the vaporizer DW-2000 plug-in adapter and S-2000 plug-in Take care not to drop the vaporizer. Do not use adapter (Vapor 2000 only) the vaporizer if it has been dropped. Damage may cause incorrect output concentration.
Operation Permanent connection (Vapor 2000 Plug-in adapter Auto Exclusion (Vapor 2000/Vapor 3000) only) 1 Press the 0 button and turn the control dial Connection may only be removed by specialized clockwise to the T position. service personnel. 2 Turn the locking lever (B) 90° counterclockwise and engage it in control dial.
Operation Transport when filled A vaporizer can be transported by itself or with Notes on transport transportable anesthesia workstations, for in- Always engage the control dial in the T position. stance: Always make sure that vaporizer is appropri- –...
Operation End of operation – Draining the vaporizer Control dial must be engaged in the 0 position CAUTION (A). Health hazard Take care not to spill anesthetic agent. Vaporizer not connected to the anesthesia workstation Do not inhale anesthetic agent vapor. Recommendation: Drain the vaporizer under suc- tion, as small quantities of anesthetic agent vapor are always released.
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Operation 1 Take an undamaged bottle provided for the cor- Ending the draining rect anesthetic agent. WARNING Dangerous mixtures of anesthetic agents The name of the anesthetic agent and the color code on the vaporizer and the anesthetic agent bottle must correspond. Otherwise the bottle could be filled with the wrong anesthetic agent.
Operation Vaporizer with Quik Fil filling device Screwing on the Quik Fil draining tool (Vapor 2000/Vapor 3000) 1 Take a bottle provided for the correct anes- thetic agent. Observe the warning notices on page 93. WARNING Dangerous mixtures of anesthetic agents Vaporizer connected to the anesthesia worksta- tion The name of the anesthetic agent and the...
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Operation CAUTION Health hazard Significant quantities of anesthetic agent could be released. The Quik Fil draining tool must sit firmly and se- curely on the anesthetic agent bottle. The anes- thetic agent bottle must be held upright. CAUTION Health hazard If the bottle is not fully screwed on, the valve in bottle will not open.
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Operation CAUTION CAUTION Health hazard Health hazard Significant release of anesthetic agents. Anesthetic agent can escape. Do not fill the bottle to the very top. Screw the sealing cap on firmly. 5 Close the drainage valve in a timely manner 5 Vapor 3000 only and continue the process with a new bottle, if Push the covering cap all the way to the end...
Operation Vapor 2000 with the Piramal Fill filling Draining the vaporizer device Observe the warning notices on page 93. Vaporizer connected to the anesthesia worksta- tion Control dial must be engaged in the 0 position (A). Vaporizer not connected to the anesthesia workstation 1 The vaporizer cannot be drained into an anes- thetic agent bottle with a permanently fitted...
Operation 4 Use a 2.5 mm (0.1 in) Allen key screwdriver to 1 Turn the drainage valve (G) clockwise to close. turn the drainage valve (E) 1 or 2 turns counter- 2 Screw the sealing cap (H) on firmly. clockwise. CAUTION 5 Drain until no more anesthetic agent can be seen in the sight glass (F) and no more anes-...
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Operation Vaporizer not connected to the anesthesia 1 Take an undamaged bottle provided for the cor- workstation rect anesthetic agent. WARNING Dangerous mixtures of anesthetic agents The name of the anesthetic agent and the color code on the vaporizer and the anesthetic agent bottle must correspond.
Operation Ending the draining Vaporizer with funnel filling system (Vapor 2000 only) See note on page 34. Observe the warning notices on page 93. Vaporizer connected to the anesthesia worksta- tion 1 Turn the drainage valve (G) clockwise to close. 2 Push the sealing block (H) in fully.
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Operation Draining the vaporizer 5 Drain until no more anesthetic agent can be seen in the sight glass (F) and no more anes- thetic agent runs into the bottle. If the anesthetic agent in the wick also needs to be removed, see "Blowing off the vaporizer" on page 105.
Operation Vaporizer not connected to the anesthesia CAUTION workstation Health hazard Anesthetic agent can escape. Screw the sealing cap on firmly. 3 Close the anesthetic agent bottle (I). CAUTION Health hazard If anesthetic agent bottles are not closed cor- rectly, the anesthetic agent vapor will escape into ...
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Operation 1 The vaporizer cannot be drained into an anes- Ending the draining thetic agent bottle with a permanently fitted Safe-T-Seal filling adapter. To drain, use a suit- able closable container (C). WARNING Dangerous mixtures of anesthetic agents Do not reuse anesthetic agent drained from the Safe-T-Seal filling device.
Operation Blowing off the vaporizer If anesthetic agent has also to be removed from the 3 Press the 0 button and set the control dial to the wick after complete draining: T position. Plug-in adapters: engage locking le- ver in control dial. 1 Set the control dial to 5 Vol.% and flush for ap- proximately 5 hours with 5 L/min Air or 1 hour with 15 L/min Air.
Operation Dispatch 1 Completely drain, see page 93, clean and disin- fect see page 117 the vaporizer. 2 Engage control dial at the T position. 3 To dispatch anesthesia workstations, remove the vaporizers if they are not permanently con- nected. 4 Carefully pack each vaporizer separately! Use the original packaging if possible.
Problem solving Problems Problems or malfunctions are listed in the following table. The table will help to identify the underlying cause and to quickly remedy it using the provided measures. The possible causes and remedies should be worked through in the order listed until the problem has been resolved.
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Problem solving Fault Cause Remedy Valves in plug-in connector Have the vaporizer repaired by damaged. specialized service personnel. Vaporizer temperature outside Allow vaporizer to reach normal specified application range, e.g. temperature, allowing at least filled with very cold anesthetic 15 minutes per °C deviation agent, or operated with both from specified range, flow and high concentration over...
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Problem solving Fault Cause Remedy Control dial cannot be set to 0 button not pressed. Press the 0 button. concentration. Interlock not switched over. Switch off other vaporizer and Interlock jamming or another va- switch over Interlock. porizer still switched on. Checks see page 74 and 84.
Problem solving Fault Cause Remedy Anesthetic agent in sight glass Vapor 2000 only Drain discolored substance is discolored. Halothane contains thymol, completely, which has accumulated in the Clean the vaporizer, vaporizer. see page 77. Vaporizer filled with incorrect Check vaporizer and drain, agent.
Problem solving Fault Cause Remedy Vaporizer not set at T, even The vaporizer may have been Flush before start-up and check though it is not connected to an- tilted at an angle of more than concentration, see remedy for esthesia workstation. 30°...
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Problem solving Fault Cause Remedy Vapor 2000 only Filling adapter not inserted prop- Loosen lever, push filling Anesthetic agent leaks from erly or lever not tightened prop- adapter in as far as it will go; safety filling system. erly. tighten lever. Lever does not press down suf- Adjust lever.
Problem solving Plug-in adapter problems Fault Cause Remedy Locking lever does not engage Control dial still set to 0. Engage control dial at the in control dial when discon- T position. nected. Locking lever cannot be swung Control dial set to 0 or Engage control dial at the 0.2 Vol.%.
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Problem solving Fault Cause Remedy Plug-in adapter not fitting flush Locking lever not engaged in Set control dial to T and engage; on plug-in connector seals. control dial, as it is set at 0 posi- insert pin on locking lever into tion or 0.2 Vol.%.
Problem solving Problems with Vapor 3000 on the anesthesia workstation with the option Vapor View Fault Cause Remedy Lighting does not work. Control dial at T setting or be- Engage control dial in the tween position 0 and T. 0 position. Anesthesia workstation not Switch on anesthesia worksta- switched on.
Cleaning and disinfection Cleaning and disinfection Safety information for preparation ..118 Preparatory procedure....119 Classification of medical devices ... 119 Testing of procedures and agents .
Cleaning and disinfection Safety information for preparation WARNING Risk of infection, risk of injury or device faults Validated reprocessing procedures must be used to reprocess the device and its accesso- ries. WARNING Damage to the interior of the vaporizer can cause incorrect output concentration and may harm the patient.
Cleaning and disinfection Preparatory procedure Classification of medical devices Testing of procedures and agents For reprocessing, medical products and their com- The cleaning and disinfection of medical products ponents are classified according to the type of ap- has been tested with the following procedures and plication and the risk resulting from it: agents.
Cleaning and disinfection Class of active ingredient Product name Manufacturer ® Quaternary ammonium Mikrozid sensitive liquid Schülke & Mayr compounds ® Mikrozid sensitive wipes ® Aldehydes Buraton 10 F Schülke & Mayr 1) Virucidal against enveloped viruses Dräger points out that oxygen- and chlorine- Performing manual cleaning including disinfec- releasing agents may cause color change in some tion...
Maintenance Overview This chapter describes the maintenance that is re- WARNING quired in order to ensure that the medical device Risk of patient injury functions correctly. These measures must be car- ried out by service personnel. The patient is put at risk if service activities are performed during ventilation.
Maintenance Inspection Regular inspections must be carried out and logged in accordance with the following requirements and at the stated intervals. Checks Device Interval Personnel responsible Inspection and Vapor 2000 units before se- every 6 months Service personnel Safety checks rial number ARSM-0001 regardless of filling system Vapor 2000 units as of serial...
Maintenance Safety checks – Check of pneumatic resistance in control dial position 0.2 Vol.%. Carrier gas: Air The safety checks are identical for the Vapor 2000 Flow: 10.0 L/min. and Vapor 3000. Vaporizer temperature: 21 to 24 °C (69.8 to 75.2 °F) WARNING Risk of patient injury...
Maintenance Repair Dräger recommends DrägerService for all repairs and that only authentic Dräger repair parts be used. Wear parts The following wear parts must be replaced by spe- cialized service personnel if any non-conformities with the specified values are found during inspec- tion and servicing or during routine checks by the user.
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Disposal Disposing of the medical device WARNING Risk of infection Clean and disinfect the device and its parts before disposal! At the end of its service life: 1 Before disposal, empty completely, see page 93, blow out, see page 105, clean and disinfect, see page 117.
Technical Data Classifications Classification Class II b according to EC Directive 93/42/EEC, Annex IX UMDNS-Code 10-144 Universal Medical Device Nomenclature – system nomenclature for medical products GMDN-Code Global Medical Device Nomenclature – uni- versal nomenclature for medical devices Vaporizer for halothane 36891 Vaporizer for isoflurane 36890...
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Technical Data The following restrictions apply subject to the altitude or the atmospheric pressure: Halothane Temperature Altitude Atmospheric (Vapor 2000 only) [°C (°F)] [m (ft)] pressure [hPa (psi)] 10 to 25 4500 580 to 1100 (50 to 77) (14764) (8.41 to 15.95) 10 to 30 3500 660 to 1100...
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Technical Data Sevoflurane Temperature Altitude Atmospheric [°C (°F)] [m (ft)] pressure [hPa (psi)] 10 to 25 5600 500 to 1100 (50 to 77) (18373) (7.25 to 15.95) 10 to 30 5500 510 to 1100 (50 to 86) (18045) (7.4 to 15.95) 10 to 35 4400 590 to 1100...
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Technical Data Direction of flow According to arrow on rear of vaporizer (see page 38) Required quality of the gases Clean, medically pure mixtures of O and Air or O Dew point 5 °C (41 °F) at 500 kPa and Air: (72.52 psi) Water content 2 mg/L at 500 kPa (72.52 psi)
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Technical Data Set values 0 and 0.2 to maximum concentration on control dial scale. When control dial at 0 and T, no output of anes- thetic agent. Accuracy of concentration delivered at vaporizer outlet at 22 °C (71.6 °F), 1013 hPa (14.69 psi) and 2.5 L/min Air with continuous flow, without ventilation pressure, without fluctuating pressure and without back pressure.
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Technical Data Rule of thumb for running time [hours] Fresh-gas flow [L/min] x concentration [Vol.%] (for 260 mL anesthetic agent) Example: Fresh-gas flow = 2 L/min, concentration = 1.4 Vol.% Running time = 30 hours Loss of anesthetic agent per 24 hours at 22 °C (71.6 °F) 0.5 mL Control dial position 0...
Technical Data Standards Conformity with fully or partially applied 93/42/EEC 1) 2) standards or directives ISO 8835-4 IEC 60601-2-13 ISO 80601-2-13 IEC 60601-1 2nd Edition IEC 60601-1 3rd Edition CSA-Z168.3 Dräger Fill filling device with ISO 5360 Dräger filling adapter Quik Fil filling system ISO 5360 Piramal Fill filling system...
Technical Data Dimensions and weights Vapor 2000 Vaporizer with Dräger Fill, Quik Fil, Piramal Fill, Vaporizer with safety filling system Safe-T-Seal filling system or with filling spout Depth Depth Width Width Dimensions in mm (in) Dimensions in mm (in) Connector Width Height Depth Connector...
Technical Data Dimensions and weights Vapor 3000 Vaporizer with Dräger Fill, Quik Fil, or Safe-T- Seal filling device Depth Width Dimensions in mm (in) Connector Width Height Depth Auto Exclusion (4.4) (9.7) (7.7) Weight in kg (lbs) Connector empty filled Auto Exclusion 8.1 (17.9) 8.8 (19.4)
Description Function Control dial position at or above ON – vaporizer switched on Some of the fresh gas is charged with anesthetic Fresh gas agent vapor in the soaked wick (F). The rest of the Fresh gas charged with anesthetic gas fresh gas is routed past the vaporizing chamber (G) through the vaporizing chamber bypass (J).
Description The two flows are mixed in the space behind the to expand or contract, based on heating or cooling, two flow controls (metering cone (B) and vaporizing the vaporizing chamber bypass (J). This process chamber bypass (J)) and routed to the outlet (C). compensates for the influence of temperature on The concentration is the result of the proportion of the saturation concentration.
Description Fresh gas flows from vaporizer inlet (D) to the va- A small bleed hole in valve (I) connects the vapor- porizing chamber-bypass (J) and then passes from izing chamber to the atmosphere to prevent any the outside to the inside through this gap. In paral- build-up of pressure.
Description Vapor 3000 Vapor 3000 also has Vapor View functions. In con- concentrations set and the filling level are also vis- junction with anesthesia workstations that also ible in darkened rooms. In addition, the position of have the Vapor View option, the anesthetic vapor- the control dial is transferred to the anesthesia izer Vapor 3000 is illuminated in the area of the workstation screen as a setting value.
Description Influence of temperature The vaporizer compensates for changes in temper- Output Halothane ature. The saturation concentration of the anes- Concentration (Vapor 2000 Concentration thetic agent, which rises as temperature rises, is [Vol.%] only) [Vol.%] automatically balanced by routing a higher propor- tion of the gas flow through the vaporizing chamber bypass (see page 140).
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Description pressure of –100 hPa (–1.45 psi) on the vaporizer, Output Isoflurane the boiling point of the anesthetic agent cannot be Concentration Concentration reached. [Vol.%] [Vol.%] The expansion of the temperature compensator is independent of ageing and hysteresis and the va- porizer's large mass provides additional compen- sation for differences in temperature.
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Description Table of anesthetic agent boiling points accord- boiling points. When operating at or above the boil- ing to altitude/atmospheric pressure ing point, the output concentrations increase signif- icantly and cannot be controlled, because virtually The table shows the physical boiling points of the pure anesthetic agent vapor is being output.
Description Influence of flow Within the specified flow range, the concentration Output Isoflurane delivered by the vaporizer is only slightly depend- Concentration Concentration ent on the fresh-gas flow. [Vol.%] [Vol.%] Reduced concentrations occur when high concen- trations are set at the same time as a high fresh-gas flow, due to the increasing pressure drop at the me- tering gaps of the vaporizer.
Description Influence of gas type and gas composition The concentration delivered by the vaporizer is de- tions of CO in the carrier gas exhibit the same ef- pendent on the composition of the fresh gas since fect as corresponding proportions of nitrous oxide the viscosity and density of the gas changes from one gas to another.
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Description The time for flushing out the vaporizing chamber and period of the dynamic effect will be longer: – the less anesthetic agent there is in the vapor- izer – the lower the set concentration is – the lower the fresh-gas flow is –...
Description Influence of atmospheric pressure/altitude The anesthetic agent partial pressure delivered by Output Enflurane the vaporizer (see "Calibration" on page 143) is Concentration (Vapor 2000 Concentration nearly independent of atmospheric pressure. [% p only) [% p Weather-based fluctuations of typically 30 hPa (0.44 psi) are negligible for all practical purposes.
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Description With a combination of low atmospheric pressures setting is corrected downward because of this dis- and higher temperatures, see chapter "Influence of play, there is an acute risk that the patient will temperature" on page 144, the anesthetic agent awaken.
Description Influence of positive and negative pressure The operating range of the vaporizer is limited to a When the back pressure is connected to a drop in negative pressure of –100 hPa (–1.45 psi or pressure from the vaporizer outlet to the patient –102.2 cmH O) and a positive pressure of 400 hPa system or to the concentration measurement point,...
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Description The concentration of the anesthetic agent in Vol.% WARNING does not change, as the relative proportions by vol- Risk of patient injury ume in the expanded gas/vapor remain the same. An anesthetic gas monitor displaying in Vol.% When using the vaporizer with a high positive would thus show no effect.
Description cation or a reduction of the boiling point by approx- To protect against excessive pressure, e.g. if the imately 3.5 °C (6.3 °F), see "Table of anesthetic fresh-gas hose is kinked, the vaporizer has a self- agent boiling points according to altitude/atmos- resetting pressure relief valve which vents fresh pheric pressure"...
Description Influence of running time Evaporation of the anesthetic agent during opera- Output Halothane tion cools the vaporizer slowly. Concentration (Vapor 2000 [Vol.%] only) The saturation concentration of the anesthetic agent in the vaporizer decreases – more rapidly the longer the duration of operation, the higher the con- centration set and the higher the fresh-gas flow se- lected, i.e.
Description Output Sevoflurane Concentration [Vol.%] Time [h] Behavior in a magnetic field (Vapor 2000 only) The influence of magnetic fields on the esthesia workstation in the vicinity of the MRI equipment must be appropriately marked and suit- vaporizer able warning notices attached. The vaporizer contains ferromagnetic parts which The vaporizer's pneumatic operating principle for are subject to attractive forces and torques in the...
List of accessories List of accessories Name and description Part No. Main devices: Dräger-Vapor 2000 for halothane M35054 Dräger-Vapor 2000 for isoflurane M35054 Dräger-Vapor 2000 for sevoflurane M35054 Dräger-Vapor 3000 for isoflurane M36500 Dräger-Vapor 3000 for sevoflurane M36500 Accessories: Dräger Fill filling adapter for: Halothane M36090 Isoflurane...
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Quality Inspection Certificate (Do not remove. Photocopy if necessary.) Drägerwerk AG & Co. KGaA Moislinger Allee 53-55 D-23542 Lübeck is certified as a manufacturer of medical devices according to Annex II of Directive 93/42/EEC and main- tains a Quality Management System conforming to the requirements of ISO 13485 and ISO 9001. We hereby confirm to our client (to be completed by the Drägerwerk AG &...
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Index Index Abbreviations ......22 Enflurane ......41 Altitude dependence .
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Index Interlock ..... . 29, 30, 88, 90 S-2000 ......75, 76 ISO conical adapter .
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Index Temperature equalization ....82 Temperature range ..... 144 Thymol .
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These instructions for use only apply to Dräger-Vapor 2000/Dräger-Vapor 3000 with the Serial No.: If no Serial No. has been filled in by Dräger, these instructions for use are provided for gen- eral information only and are not intended for use with any specific device or unit.
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