Dräger Medical Vapor 2000 Operating Instructions Manual

Dräger Medical Vapor 2000 Operating Instructions Manual

Anesthetic vaporizer
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D
M E D I C A L
®
Dräger Vapor
2000
Anesthetic Vaporizer
Operating Instructions

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Summary of Contents for Dräger Medical Vapor 2000

  • Page 1 M E D I C A L ® Dräger Vapor 2000 Anesthetic Vaporizer Operating Instructions...
  • Page 2 NOTICE Proprietary Information This document contains information in which Dräger claims proprietary rights. The information may not be reproduced in whole or in part except as authorized in writing by Dräger. This information is the property of Dräger, it is provided solely for the use intended. Repairs/Modifications Repairs on this device shall be performed only by DrägerService or its Authorized Service Centers.
  • Page 3: Table Of Contents

    Instructions are to be used with each Vapor, the serial number purely for informational purposes and not for actual use with of the Vapor 2000 assigned to these Operating Instructions is a Vapor. On each Vapor, the serial number is indicated on its indicated on the back of this document.
  • Page 4 Contents Shut-Down ......... . 49 Draining the Vapor .
  • Page 5: Operator's Responsibility For Patient Safety

    Important Safety Information Operator's Responsibility for Patient Safety Operator's Responsibility for Limitation of Liability Patient Safety Draeger's liability, whether arising out of or related to manufacture and sale of the goods, their installation, For correct and effective use of the product and in order to demonstration, sales representation, use, performance, or avoid hazards, it is mandatory to carefully read and to otherwise, including any liability based upon Draeger's...
  • Page 6: Warranty

    Important Safety Information Warranty Warranty Application of this warranty is subject to the following conditions: All Draeger products are guaranteed to be free of defects for 1. Draeger or its authorized representative must be promptly a period of one year from date of delivery. The following are notified, in writing, upon detection of the defective material exceptions to this warranty: or equipment.
  • Page 7: Definitions

    DW-2000 Code letter for anesthetic agent for which Typing Conventions Vapor 2000 has been calibrated, or for which plug-in adapter is coded Control settings are designated as »Control Setting«, e.g.: minimum permissible filling level on Control dial setting at »...
  • Page 8: Summary Of Warnings And Cautions

    Damage to the Vapor may result in incorrect output concentration with the risk of serious patient injury or death. WARNING! Do not use accessories with the Vapor 2000 anesthetic vaporizer that are not listed in the ordering WARNING! information (see page 73).
  • Page 9: Precautions During Preparation

    If the Vapor is tilted during filling, it can be overfilled. WARNING! This may result in delivered concentrations being too When using Vapor 2000 on third-party anesthesia high or too low. systems, it is the responsbility of the user to ensure that all technical specifications of Vapor and...
  • Page 10 Important Safety Information Summary of WARNINGS and CAUTIONS WARNING! WARNING! The plug-in adapter must be level and stable on the A dropped anesthetic bottle may release significant o-ring seals. If this is not the case, there may be a loss quantities of anesthetic agent, resulting in a serious of fresh gas, leaks, excessively low output concentra- health hazard.
  • Page 11: Precautions During Checks Of Readiness For Operation

    WARNING! Vapor 19.n plug-in adapters, which are silver in color, Dräger recommends use of a continuously measuring must never be used on the Vapor 2000. oxygen monitor with alarm system for detecting insufficient supply of oxygen, e.g. due to leaks.
  • Page 12: Precautions During Care

    Important Safety Information Summary of WARNINGS and CAUTIONS WARNING! WARNING! If no pre-use concentration checks are performed, an For plug-in connectors without valves, the fresh-gas incorrect concentration may be displayed. supply is disconnected when the Vapor has been lifted off the plug-in connector. Fresh gas and anesthetic agent vapor may escape in this situation.
  • Page 13: Precautions During Shut-Down

    Important Safety Information Summary of WARNINGS and CAUTIONS CAUTION! WARNING! Do not immerse Vapor or filling adapter in detergents. If the lever is not closed properly, fresh gas and anesthetic agent vapor may escape. This may result in Do not allow detergent to penetrate under the control dial. a health hazard.
  • Page 14: Precautions During Maintenance

    6 month intervals. A record must be kept on this preventive maintenance. Maintenance or repair of the Vapor 2000 anesthetic vaporizer shall be performed only by Dräger authorized technical service representatives.
  • Page 15: Intended Use

    Intended Use Intended Use Due to the pneumatic principle and the low amount of ferromagnetic material, Vapor 2000 can generally be used in magnetic fields, i. e. in conjunction with nuclear spin ®1) The Dräger Vapor 2000 (Vapor 2000) is a non-heated, tomography (MRI) together with anesthetic workstations calibrated vaporizer designed to enrich the fresh gas flow of...
  • Page 16: Method Of Operation

    Method of Operation Control dial Settings Method of Operation WARNING! Always handle Vapor with great care. Be careful not to tilt or drop Vapor. Do not carry by the control dial, the protective caps or the locking lever for the plug-in adapter. Risk of injury.
  • Page 17: T" - Transport

    Method of Operation Connection and Interlock Systems »T« – Transport: This position must be set each time the Vapor is removed from the anesthesia delivery system or is placed on the parking holder. 1 Press the »0«-button and 2 Turn control dial clockwise to »T« transport setting – »0« button engages.
  • Page 18: Plug-In Adapter Dw-2000 With Interlock 2

    Method of Operation Connection and Interlock Systems Plug-in adapter DW-2000 with Interlock 2 for connecting to Dräger plug-in connectors. For anesthesia delivery systems with two plug-in connectors combined with Interlock 2. The locking bar, which can only be engaged in the control dial when at »0«...
  • Page 19: Permanent Connection With Triple Vaporizer Exclusion

    Method of Operation Connection and Interlock Systems Permanent connection with triple vaporizer exclusion systems A permanent installation in fresh gas line for anesthesia delivery systems, with the appropriate connector options. For anesthesia delivery systems with the former triple vaporizer exclusion system combined with the Interlock NMD. When a Vapor is switched on, a lever is activated which prevents other Vapors on adjacent connectors from being switched on.
  • Page 20: Filling Systems

    Method of Operation Filling Systems Filling Systems For filling the Vapor with the specified anesthetic agent and for draining. The filling level is visible with minimum and maximum levels marked and a third (middle) mark which shows when a whole bottle (250 mL) can be used.
  • Page 21: Preparation

    Preparation Installation of Connection Systems Preparation Installation of Connection Systems WARNING! Use only authentic Dräger parts. Ensure that only compatible materials are used with anesthetic agents. Only trained and factory authorized service personnel may install plug-in adapters, because hey must be dismantled and checked.
  • Page 22: Before Using For The First Time

    (for each type of anesthesia delivery system). WARNING! When using Vapor 2000 on third-party anesthesia systems, it is the responsbility of the user to ensure that all technical specifications of Vapor and anesthesia delivery system are met.
  • Page 23: Filling The Vapor

    Preparation Filling the Vapor Filling the Vapor WARNING! Many anesthetic agent monitors do not identify WARNING! mixtures of anesthetic agents and/or do not detect Take care not to spill anesthetic agent. that the anesthetic agent being measured differs from Do not inhale anesthetic agent vapor. the agent that was set.
  • Page 24: Vapor With Keyed Filling System

    Preparation Filling the Vapor If a Vapor is filled with the wrong anesthetic agent, clearly mark Vapor with label indicating the substance and a WARNING not to use the device, then call DrägerService for repair. WARNING! Make sure that the drainage valve is closed before filling Vapor.
  • Page 25 Preparation Filling the Vapor 1 Only use anesthetic agent bottles with anesthetic agent- specific collars on the neck. Select a keyed filler adapter specific to the anesthetic agent – make sure any color coding or labeling on the keyed filler adapter corresponds to the anesthetic agent used.
  • Page 26 Preparation Filling the Vapor 1 Push keyed filler adapter completely into opening of the filling device until it engages. 2 Swing lever back in and tighten – do not use excessive When filling, lever does not need force. to be flush with vaporizer front! Lever does not need to be flush with the front of the vaporizer.
  • Page 27 Preparation Filling the Vapor To finish the filling process: 1 Swing anesthetic agent bottle down. 2 Check filling level on viewing glass – Vapor must be hanging vertical or standing upright during this check. The filling level must be visible and must not exceed the maximum mark.
  • Page 28: Vapor With Quik Fil Filling System

    Preparation Filling the Vapor Vapor with Quik Fil filling system Heed all warnings on pages 22, 23. If Vapor is connected to an anesthesia delivery system, leave control dial engaged at »0«. When filling during operation: Fresh gas flow can remain as set. 1 Set control dial to »0«...
  • Page 29 Preparation Filling the Vapor 1 Unscrew sealing cap on the filling system slowly so that any pressure in the Vapor can escape slowly. 2 Insert bottle so that the flanges install into the matching slots on the filling connector. Only use bottles with correct flanges. Observe color coding on the bottle and on the Vapor.
  • Page 30: Vapor With Funnel Filling System

    Preparation Filling the Vapor Vapor with funnel filling system Heed all warnings on pages 22, 23. If the Vapor is connected to an anesthesia delivery system, leave control dial engaged at »0«. Filling during operation: Fresh gas flow can remain as set. 1 Set the control dial to »0«...
  • Page 31: Connecting The Vapor

    Preparation Connecting the Vapor Tighten sealing cap firmly. WARNING! Always make sure to tighten sealing cap firmly. If this is not done properly, fresh gas and anesthetic agent may escape when Vapor is switched on. Close bottle, even if completely empty, and allow any residues of anesthetic agent to evaporate under a fume hood or fan, if possible.
  • Page 32: Vapor With Tapered Connectors Without Interlock System

    Preparation Connecting the Vapor When several vaporizers are connected, they must always be right next to each other. For the Interlock to operate, it is essential that there is direct contact on the Interlock pin. For triple plug-in connectors with built-in transmission of safety locking between the two outer plug-in positions, the middle plug-in position may remain unoccupied.
  • Page 33 Preparation Connecting the Vapor WARNING! Never use Vapor within a breathing circuit. Risk of incorrect output concentration and high resistance. 1 Connect gas inlet and outlet line to Vapor. WARNING! When connecting the Vapor, make sure that the direction of flow is correct and corresponds with arrow on the back of the Vapor (see page 21).
  • Page 34: Operation In Mri Fields

    field are subject to torques and forces which are not applicable under any Record the test results and the approval of Vapor 2000/ condition as there is a variety of types and shields of MRI anesthetic workstation for the respective position near the scanners.
  • Page 35: Checking Readiness For Operation

    Re-engage locking lever in control dial. Isoflurane Sevoflurane Plug-in adapter DW-2000: Only use white plug-in adapter for Vapor 2000. WARNING! Vapor 19.n plug-in adapters, which are silver in color, must never be used on the Vapor 2000. 4 Drop-in pin on locking lever secure and straight.
  • Page 36 Checking Readiness for Operation Connecting the Vapor Plug-in adapter S-2000: Only use white plug-in adapters for Vapor 2000. WARNING! Vapor 19.n plug-in adapters, which are grey in color, must never be used on Vapor 2000. 1 Stop mechanism undamaged, not buckled.
  • Page 37: Checking Concentration

    Checking Readiness for Operation Checking Concentration Checking Concentration Check weekly if not continuously monitored. Preparation Fill Vapor – at least half full between minimum and maximum mark. Allow the filled Vapor to warm up to room temperature of 20 to 24 Wait long enough for the temperature to equalize –...
  • Page 38: Determining Permissible Range

    Checking Readiness for Operation Checking Concentration If the value displayed on the monitor is — in % partial pressure: no correction required. — in vol.%: convert to partial pressure: Measured value [vol.%] · atmospheric pressure [cm H Concentration = 1013 cm H [% partial pressure] Determining permissible range See accuracy data (see "Technical Data", page 61) for the...
  • Page 39: Operation

    Operation Checklist – Checks Before Each Use Operation Checklist – Checks Before Each Use Pre-conditions Operating parameters (e.g. temperature) are within the specified operating range – otherwise, wait for temperature to equalize with ambient temperature (see page 56). WARNING! High temperatures at low atmospheric pressures (high altitudes) may result in an uncontrolled excessive dosage (see page 67).
  • Page 40 Operation Checklist – Checks Before Each Use WARNING! When using Low Flow and Minimum Flow, the concentration in the breathing system may deviate significantly from Vapor setting. For this reason, measurement of inspiratory and/or expiratory anesthetic agent concentration is essential. Operation in magnetic field Vapors must not be changed or left unsecured in magnetic fields.
  • Page 41: Setting/Checking

    Operation Checklist – Checks Before Each Use Setting/checking — Filling level in the viewing glass is between the minimum and maximum marks – must not exceed maximum mark. — Filling system: — Keyed filling system: sealing block is in place and flush, and lever is locked.
  • Page 42: Adjusting Concentration Of Anesthetic Agent

    Operation Adjusting Concentration of Anesthetic Agent Check each connected vaporizer as follows: — Set vaporizer to any concentration. — All other vaporizers must be switched off, locked in their »0« positions, and impossible to switch on. — If there is an anesthetic agent vapor identification system, check that the identification system shows the correct anesthetic agent.
  • Page 43: Changing Anesthetic Agent

    Operation Changing Anesthetic Agent 1 When the mark above the minimum mark is reached, the Vapor may be refilled with 250 mL (standard anesthetic agent bottle). 2 When the minimum mark is reached, (at the latest), fill Vapor (see “Filling the Vapor”, page 23 to page 31). If the anesthetic agent monitor shows implausible values, check the Vapor for incorrect filling (particularly Vapors with funnel filling system), and check the monitor for wrong...
  • Page 44: Ending Administration Of Anesthetic Agent

    Operation Ending Administration of Anesthetic Agent Ending Administration of Anesthetic Agent 1 Switch Vapor off by turning control dial clockwise until it engages at »0« to prevent it being switched on accidentally. Then, if required: Switch off fresh gas flow on the anesthesia delivery system. WARNING! Never switch off fresh gas flow before the Vapor is switched off.
  • Page 45: Disconnecting The Vapor

    Operation Disconnecting the Vapor Disconnecting the Vapor WARNING! Take care not to drop Vapor. Do not use Vapor if it has been dropped. Damage may cause incorrect output concentration. Do not carry Vapor by the control dial, control dial cap, or locking lever on plug-in adapter.
  • Page 46: For Tapered Connectors

    Operation Transport of Filled Vapors For tapered connectors 1 Press »0« button and turn control dial clockwise to »T« until it engages. 2 Detach gas supply and gas delivery lines from Vapor. The Vapor can now be disconnected. WARNING! When using tapered connectors, disconnecting the vaporizer will disconnect the fresh gas line.
  • Page 47 Operation Transport of Filled Vapors Anesthesia delivery systems with securely fastened Vapors may be moved within or between buildings with the control dial set at »0«, if there is no risk of tilting by more than 30 WARNING! o o o o When Vapor is tilted at an angle of more than 30 —...
  • Page 48: Care

    Care Cleaning Care CAUTION! Many materials are sensitive to certain organic solvents sometimes used for cleaning and disinfecting (e.g., CAUTION! phenols, halogen releasing compounds, oxygen releasing Do not immerse Vapor or keyed filler adapter in compounds, strong organic acids, etc.). Exposure to such detergents.
  • Page 49: Shut-Down

    Shut-Down Draining the Vapor Shut-Down WARNING! Draining the Vapor Do not use ferromagnetic keyed filler or drain adapter or tools when the filling or draining procedure is carried out in magnetic fields. Ferromagnetic adapter or tools can be moved by magnetic attraction. Risk of injury. WARNING! Take care not to spill anesthetic agent.
  • Page 50: Vapor With Quik Fil Filling System

    Shut-Down Draining the Vapor Drain anesthetic agent until the viewing glass is empty and no more anesthetic agent flows into the bottle. If the anesthetic agent in the wick also needs to be removed, see "Flushing the Vapor", page 53. WARNING! Do not fill anesthetic agent bottles to the very top.
  • Page 51 Shut-Down Draining the Vapor Use only undamaged bottles and Quik Fil drain adapter. WARNING! The Quik Fil drain adapter must be flush and secure on the bottle. Otherwise significant quantities of anesthetic gas may escape. Use an anesthetic agent-specific bottle for the appropriate agent.
  • Page 52: Vapor With Funnel Filling System

    Shut-Down Draining the Vapor If necessary, close drainage valve before the bottle is full and repeat procedure using a second bottle. Close drainage valve by turning clockwise. Pull out bottle and keep upright. Unscrew the drain adapter from the bottle; otherwise the bottle valve will not close and anesthetic agent may evaporate or spill out.
  • Page 53: Flushing The Vapor

    Shut-Down Flushing the Vapor 1 Hold an anesthetic agent-specific bottle for the appropriate agent below the drainage outlet. WARNING! To prevent dangerous mixtures of anesthetic agents, always verify that the anesthetic agent name and the color coding on the Vapor correspond to those on the anesthetic agent bottle.
  • Page 54: Storage

    Shut-Down Storage Storage For storage periods longer than 6 months: Drain the Vapor as described on page 49 to 53 and flush out (see page 53). Press »0« button and engage control dial at »T«. For plug-in adapters, engage locking lever in the control dial.
  • Page 55: Maintenance Intervals

    – this applies also when returning Vapors for repair (see page 48). The Vapor 2000 maintenance schedule is specified in the DrägerService Test Certificate for the Vapor 2000. The below listed wear parts must be replaced if inproper function is identified during maintenance or routine check by the...
  • Page 56: Troubleshooting

    Troubleshooting Troubleshooting Fault Cause Remedy Operation No concentration delivered or Vapor not full, Vapor empty Fill Vapor concentration excessively high/low Set control dial to ≥0.2 vol.% Control dial setting at »0« or »T« No Vapor connected, or if several Connect Vapor, or close open connections, one unoccupied and open connections with Vapor or by direct gas connections...
  • Page 57 Troubleshooting Fault Cause Remedy The vaporizer detection system on Coding of plug-in adapter or Vapor Check coding, if necessary re-install, anesthesia delivery system to which damaged, faulty, or incorrectly installed repair Vapor is connected displays anesthetic agent which is different from the Vapor Monitor indicates different anesthetic A different anesthetic agent has just been Flush breathing system or wait for gas to...
  • Page 58: Transport, Procedure After Tilting

    Troubleshooting Fault Cause Remedy Filling level cannot be read in viewing Vapor completely empty Refill Vapor glass Vapor overfilled Drain Vapor to maximum mark. Check concentration Viewing glass display faulty Repair Anesthetic agent is obscured in Halothane contains thymol, which has Drain discolored substance viewing glass.
  • Page 59: Draining And Filling Vapor

    Troubleshooting Fault Cause Remedy Draining and filling Vapor Anesthetic agent is leaking from Drain valve not closed Close drain valve drainage outlet Vapor accidentally filled with incorrect Drain Vapor completely and blow off, see anesthetic agent pages 49 to page 53; repair Anesthetic agent does not flow into Keyed filler adapter being used without Use keyed filler adapter with check valve...
  • Page 60: Plug-In Adapter

    Troubleshooting Fault Cause Remedy Plug-in adapter Locking lever does not engage in Control dial still set at »0« Set control dial to »T« and engage control dial when disconnected Control dial to »0« or ≥0.2 vol.%. Locking lever cannot be swung out of Set control dial to »T«...
  • Page 61: Technical Data

    Technical Data Technical Data Classification Class II b as per EC Directive 93/42/EEC Annex IX UMDNS-Code 10-144 Universal Medical Device Nomenclature System – Nomenclature for medical products Operating range Ambient and Vapor Temperature during operation 10 to 40 but Halothane and Isoflurane Vapors may only be operated between 35 and 40 C if atmospheric pressure is between 850 and 1100 cm H...
  • Page 62 Anesthetic agent only escapes in very small quantities (<2.5 mL) into Vapor or towards patient. Flow resistance (without connector) at 10 L/min air in cm H Vapor set at »0« or »T« <40 <35 <30 Vapor switched on <150 <70 <35 Materials Vapor 2000 contains no latex.
  • Page 63 Technical Data 2) 3) 4) Vapor conforms to Standards EN 740 2) 4) DIN 13252 ASTM F1161 CSA-Z168.3 ISO 5358 2) 3) 4) ISO 8835 (1997) 93/42/EEC Medical Device Directive The keyed filling system and Quik Fil EN 1280 filling system conform to the following ISO 5360 Standards for anesthetic agent-specific CSA-Z5360...
  • Page 64: What's What

    What’s What What’s What Front view 1 Control dial with concentration scale and letter for anesthetic agent 2 Control dial cap color coded for anesthetic agent with Interlock coding 3 »0« button for setting »0« and »T« 4 Indication of concentration units 5 Indication of anesthetic agent and Vapor type 6 Viewing glass for filling level 7 Drainage valve...
  • Page 65: Theory Of Operation

    Theory of Operation Operating Principles Theory of Operation Operating Principles Control dial at »0« (switched off) Fresh gas (arrow) flows from Vapor inlet 1 to the vaporizing chamber-bypass 2 and then passes from the outside to the inside through this gap. In parallel, some of the fresh gas flows via an additional bypass 3 and flow control cone 4 to Vapor outlet 5.
  • Page 66: Control Dial Above "On" (Switched On)

    Theory of Operation Calibration Control dial above »ON« (switched on) Fresh gas (arrow) is routed through valves 7a and 7b, linked to the control dial 8 and through the vaporizing chamber 6. Valve 7c closes off bypass 3. Some of the fresh gas is enriched with anesthetic agent vapor (arrow with dot) in the saturated wick 9.
  • Page 67: Influence Of Temperature

    Theory of Operation Influence of Temperature Influence of Temperature Output Halothane concentration concentration Vapor compensates for changes in temperature. The [vol.%] [vol.%] saturation concentration of the anesthetic agent, which rises with temperature, is automatically balanced by routing a higher proportion of the gas flow through the vaporizing chamber- bypass (see page 65).
  • Page 68: Influence Of Flow

    Theory of Operation Influence of Flow Influence of Flow Output Halothane concentration concentration Within the specified flow range, the concentration delivered by [vol.%] [vol.%] the Vapor is only slightly dependent on fresh gas flow. The output concentration is reduced slightly when high concentrations are set at the same time as a high fresh gas flow.
  • Page 69: Influence Of Gas Composition

    Theory of Operation Influence of Gas Composition Influence of Gas Composition The delivered concentration is dependent on the composition of the fresh gas since the viscosity and density of the gas changes from one gas to another. The Vapor is calibrated with air because the concentration delivered is then exactly in the middle of the range for the available anesthetic gas mixtures.
  • Page 70: Influence Of Atmospheric Pressure

    Theory of Operation Influence of Atmospheric Pressure Influence of Atmospheric Pressure The anesthetic agent partial pressure delivered by Vapor (see "Calibration", see page 66) is all but independent of atmospheric pressure. Therefore weather-induced fluctuations do not need to be taken into account and altitude-induced pressure changes in the range 700 to 1100 cm H O will only lead to small deviations within the accuracy specified.
  • Page 71: Influence Of Fluctuations In Pressure During Ventilation

    Theory of Operation Influence of Fluctuations in Pressure During Ventilation For effective O flushing on Dräger anesthesia delivery systems a negative pressure is produced at the Vapor outlet which may be up to 100 cm H 100 cm H O negative pressure has the same effect as raising the altitude by 1000 m or a drop in boiling point of about C (see page 67).
  • Page 72: Influence Of Running Time

    Theory of Operation Influence of Running Time Influence of Running Time Concentration Halothane delivered Evaporation of the anesthetic agent during operation cools the [vol.%] Vapor slowly. The saturation concentration of the anesthetic agent in the Vapor decreases more rapidly the longer the duration of operation, the higher the concentration set and the higher the fresh gas flow selected, i.e.
  • Page 73: Ordering Information

    Ordering Information Influence of Running Time Ordering Information Name and description Order no. Keyed filler adapter s for Sevoflurane M 31 930 Keyed filler adapter i for Isoflurane M 30 290 Keyed filler adapter e Enflurane M 30 289 Keyed filler adapter h Halothane M 30 288 Ball-check valve modification set (for older Draeger keyed filler adapter)
  • Page 74: Index

    Index Index »0« setting ........16 Definitions .
  • Page 75 Index Keyed filler adapter ....20 Repair ......... . . 55 Keyed filling system .
  • Page 76 These Instructions for Use apply only to Vapor 2000 with Serial No.: If no Serial No. has been filled in by Dräger these Instructions for Use are provided for general information only and are not intended for use with any specific machine or device.

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