Instructions for Use
76 Pages
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D M E D I C A L
Dräger Vapor® 2000 Anesthetic Vaporizer
MT-505-98
Operating Instructions
NOTICE
D
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. Information about repairs can be obtained from Dräger or Authorized Dealers. Dräger will not be responsible for injury to persons or damage to property arising directly or indirectly out of unauthorized repairs or modifications to this device. Furthermore, any unauthorized repairs or modifications void any warranty extended by Dräger. This document is provided for your information only. It will not be exchanged or updated without request.
Trademarks The Dräger name and logo are registered trademarks of Dräger. Dräger Vapor® is a registered trademark of Dräger. © Dräger Medical AG & Co. KGaA
Contents
NOTE: In order to make it very clear which Operating Instructions are to be used with each Vapor, the serial number of the Vapor 2000 assigned to these Operating Instructions is indicated on the back of this document.
Operating Instructions without such a number are issued purely for informational purposes and not for actual use with a Vapor. On each Vapor, the serial number is indicated on its nameplate.
Contents
Preparation... 21 Installation of Connection Systems... 21
Operator's Responsibility for Patient Safety... 5
Before Using For the First Time... 22
Limitation of Liability... 5
Filling the Vapor... 23
Warranty... 6 Definitions... 7 Abbreviations and Symbols... 7 Definitions of Terms... 7 Typing Conventions... 7 Summary of WARNINGS and CAUTIONS... 8
Operating Instructions Vapor ® 2000
General precautions... 8 Precautions during preparation... 9 Precautions during checks of readiness for operation . .11 Precautions During Operation...11 Precautions during care...12 Precautions during shut-down...13 Precautions during storage and shipping...13 Precautions during maintenance...14
Vapor with keyed filling system... 24 Vapor with Quik Fil filling system... 28 Vapor with funnel filling system... 30 Connecting the Vapor... 31 Vapor with plug-in adapter... 31 Vapor with tapered connectors without Interlock System... 32 Operation in MRI fields... 34 Checking Readiness for Operation... 35 Checking Concentration... 37
Intended Use...15
Preparation... 37 Setting... 37 Measuring... 37 Correcting measured values... 37 Determining permissible range... 38 Test result... 38 After the test... 38
Method of Operation...16
Operation... 39
Control dial Settings...16
Checklist – Checks Before Each Use... 39
»ON« – Switching on and adjusting concentration:...16 »0« – Switching off:...16 »T« – Transport:...17 Connection and Interlock Systems...17
Pre-conditions... 39 Setting/checking... 41 Adjusting Concentration of Anesthetic Agent... 42
Plug-in adapter/Plug-in connector...17 Plug-in adapter DW-2000 with Interlock 2...18 Plug-in adapter S-2000 with Interlock S...18 Permanent connection with triple vaporizer exclusion systems...19 Tapered connector, 23 mm...19 Filling Systems...20
Ending Administration of Anesthetic Agent... 44
Keyed filling system...20 Quik Fil®filling system...20 Vapor with funnel filling system...20
Changing Anesthetic Agent... 43 End of Use... 44 Disconnecting the Vapor... 45 For plug-in connectors... 45 For tapered connectors... 46 For permanent connections... 46 Transport of Filled Vapors... 46 Care... 48 Cleaning... 48 Disinfecting... 48
3
Contents
Shut-Down... 49 Draining the Vapor... 49 Vapor with keyed filling system... 49 Vapor with Quik Fil filling system... 50 Vapor with funnel filling system... 52 Flushing the Vapor... 53 Storage... 54 Shipping... 54 Return, Disposal... 54 Maintenance Intervals... 55 Inspection and Service... 55 Wear parts... 55 Troubleshooting... 56 Operation... 56 Transport, procedure after tilting... 58 Draining and filling Vapor... 59 Plug-in adapter... 60 Technical Data... 61 What’s What... 64 Front view... 64 Back view... 64 Theory of Operation... 65 Operating Principles... 65 Control dial at »0« (switched off)... 65 Control dial at »T« (transport)... 65 Control dial above »ON« (switched on)... 66 Calibration... 66 Influence of Temperature... 67 Influence of Flow... 68 Influence of Gas Composition... 69 Influence of Atmospheric Pressure... 70
Influence of Fluctuations in Pressure During Ventilation... 71 Influence of Running Time... 72 Ordering Information... 73 Index... 74
4
Operating Instructions Vapor ® 2000
Influence of Positive/Negative Pressure Relative to Ambient and Dynamic Pressure... 70
Important Safety Information Operator's Responsibility for Patient Safety
Operator's Responsibility for Patient Safety For correct and effective use of the product and in order to avoid hazards, it is mandatory to carefully read and to observe all portions of this manual. The design of the equipment, the accompanying literature, and the labeling on the equipment take into consideration that the purchase and use of the equipment are restricted to trained professionals, and that certain inherent characteristics of the equipment are known to the trained operator. Instructions, warnings, and caution statements are limited, therefore, largely to the specifics of the Draeger design. This publication excludes references to various hazards which are obvious to a medical professional and operator of this equipment, to the consequences of product misuse, and to potentially adverse effects in patients with abnormal conditions. Product modification or misuse can be dangerous. Draeger disclaims all liability for the consequences of product alterations or modifications, as well as for the consequences which might result from the combination of this product with other products whether supplied by Draeger or by other manufacturers if such a combination is not endorsed by Draeger.
Limitation of Liability Draeger's liability, whether arising out of or related to manufacture and sale of the goods, their installation, demonstration, sales representation, use, performance, or otherwise, including any liability based upon Draeger's Product Warranty, is subject to and limited to the exclusive terms and conditions as set forth, whether based upon breach of warranty or any other cause of action whatsoever, regardless of any fault attributable to Draeger and regardless of the form of action (including, without limitation, breach of warranty, negligence, strict liability, or otherwise). THE STATED EXPRESSED WARRANTlES ARE IN LlEU OF ALL OTHER WARRANTIES, EXPRESSED OR IMPLIED, INCLUDING, WITHOUT LIMITATION, WARRANTlES OF MERCHANTABILITY, FITNESS FOR ANY PARTICULAR PURPOSE, OR NONINFRINGEMENT. Draeger shall not be liable for, nor shall buyer be entitled to recover any special incidental, or consequential damages or for any liability incurred by buyer to any third party in any way arising out of or relating to the goods.
Operating Instructions Vapor® 2000
The operators of the anesthesia system must recognize their responsibility for choosing appropriate safety monitoring that supplies adequate information on equipment performance and patient condition. Patient safety may be achieved through a wide variety of different means ranging from electronic surveillance of equipment performance and patient condition to simple, direct observation of clinical signs. The responsibility for the selection of the best level of patient monitoring lies solely with the equipment operator.
5
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 a period of one year from date of delivery. The following are exceptions to this warranty:
1. Draeger or its authorized representative must be promptly notified, in writing, upon detection of the defective material or equipment. 2. Equipment or material out of specification must be returned, shipping prepaid, to Draeger or its authorized representative. 3. Examination by Draeger or its authorized representative must confirm that the defect is covered by the terms of this warranty. 4. Notification in writing, of defective material or equipment must be received by Draeger or its authorized representative no later than two (2) weeks following expiration of this warranty.
1. The defect shall be a result of workmanship or material. Defects caused by misuse, mishandling, tampering, or by modifications not authorized by Draeger or its representatives are not covered. 2. Rubber and plastic components and materials are warranted to be free of defects at time of delivery. 3. Oxygen sensor capsules have a six-month limited warranty from the date of delivery. Any product which proves to be defective in workmanship or material will be replaced, credited, or repaired with Draeger holding the option. Draeger is not responsible for deterioration, wear, or abuse. In any case, Draeger will not be liable beyond the original selling price.
In order to assure complete protection under this warranty, the Customer Registration Card and/or Periodic Manufacturer's Service Record (if applicable) must be returned to Draeger within ten (10) days of receipt of the equipment. The above is the sole warranty provided by Draeger. No other warranty expressed or implied is intended. Representatives of Draeger are not authorized to modify the terms of this warranty.
Dräger Medical, Inc., Telford, PA
Operating Instructions Vapor® 2000
6
Important Safety Information Definitions
Definitions Abbreviations and Symbols Abbreviation
Meaning
Abbreviation
Meaning
Air
Medical Air
ASTM
N2 O
Medical Nitrous Oxide
American Society for Testing and Materials
O2
Medical Oxygen
CSA
Canadian Standards Organization
CE0123
Conformité Européenne Vapor 2000 conforms to 93/42 EEC Medical Device Directive
EN
European Standard (European Norm)
ISO
International Organization for Standardization
®
Registered trademark
™
Trademark, protected trademark
% rel.
relative deviation as % of value
[
Refer to Operating Instructions
ON
Vapor switched on
Definitions of Terms
WARNING! A WARNING statement refers to conditions with a possibility of personal injury if disregarded.
Operation between »0« setting and this mark is not allowed, as Vapor has not been calibrated for this range 0.2; 0.4;...
Concentration scale on Vapor control dial for values up to and including 5 vol.%
6 7 8
Concentration marks on Vapor control dial that point to the danger of high dosage and limited flow range
NOTE: A NOTE provides additional information intended to avoid inconveniences during operation.
vol.%
Volume percent anesthetic agent in fresh gas at Vapor outlet. Unit of concentration, see "Calibration", page 66
Inspection Service
= =
0
on key to stop control dial. »0« setting on control dial, see page 16
Repair
=
T
Transport setting (»T« setting) on control dial, see page 16
Maintenance
=
Preventive Maintenance
=
on back of Vapor or on connector indicates direction of flow of Vapor H, E, I, S
Operating Instructions Vapor® 2000
CAUTION! A CAUTION statement designates the possibility of damage to equipment if disregarded.
min max
on control dial or on plug-in adapter DW-2000 Code letter for anesthetic agent for which Vapor 2000 has been calibrated, or for which plug-in adapter is coded minimum permissible filling level on viewing glass
examination of actual condition measures to maintain specified condition measures to restore specified condition inspection, service, and repair, where necessary Maintenance measures at regular intervals
Typing Conventions Control settings are designated as »Control Setting«, e.g.: Control dial setting at »T«.
maximum permissible filling level on viewing glass
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Important Safety Information Summary of WARNINGS and CAUTIONS
Summary of WARNINGS and CAUTIONS General precautions
WARNING! Strictly follow this Operator's Instruction Manual. Any use of the product requires full understanding and strict observation of all portions of these instructions. The equipment is only to be used for the purpose specified under "Intended Use" (see page 15) and in conjunction with appropriate patient monitoring. Observe all WARNINGS and CAUTIONS as rendered throughout this manual and on labels on the equipment.
WARNING! Do not use accessories with the Vapor 2000 anesthetic vaporizer that are not listed in the ordering information (see page 73).
WARNING! For operation in magnetic fields the combination of Vapor, anesthesia workstation, and MRI- (MRT, NMR, NMI) scanner must be tested by experts (trained and factory authorized technical service representatives for anesthetic machines and MRI scanners and application experts respectively) prior the first use to ensure proper Vapor and interface function in the specific magnetic fields. Otherwise uncontrolled concentrations and/or leakage and/or malfunction of the interlocksystem may occur (see page 34). The testing has to take into consideration all positions of the anesthesia workstation including Vapor in which it will be operated in the MRI theatre during daily use. Additionally it is necessary to check if the imaging of the MRI scanner is adversely affected by the Vapor and the anesthesia workstation.
Vapor can be moved by magnetic attraction. Risk of injury.
8
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. Do not use the Vapor if it has been dropped. Damage to the Vapor may result in incorrect output concentration with the risk of serious patient injury or death.
WARNING! Do not use Vapor at an angle of more than 30o, when the control dial is set at »0« or above »0«, because this may result in incorrect output concentration or cause anesthetic agent to escape from the vaporizer.
WARNING! When filled, the Vapor may be transported in any position only if the control dial is set to »T«. Any other control dial setting may cause anesthetic agent to escape from the vaporizer. Liquid anesthetic agent may effect the flow control system: The concentration delivered may be significantly higher or lower than the concentration set on the control dial.
WARNING Vapor must always be used under the supervision of qualified medical personnel in order to obtain immediate assistance in the event of a problem.
CAUTION! Restriction of Distribution Federal Law and Regulations in the United States and Canada restrict this device to sale by or on the order of a physician.
Operating Instructions Vapor® 2000
WARNING!
WARNING! Under no circumstances should Vapor ever be used at atmospheric pressures and temperatures at which the anesthetic agent could start to boil (see page 67), as the concentration delivered will rise and be uncontrolled.
Important Safety Information Summary of WARNINGS and CAUTIONS
Precautions during preparation
WARNING! 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 connectors, because they must be dismantled and checked. Failure to observe above precautions may result in incorrect output concentration or cause anesthetic vapor to escape from the vaporizer.
WARNING! If the direction of flow between inlet and outlet port of the vaporizer is reversed, the delivered concentration will be incorrect and often too high.
WARNING! If exact mounting screw specifications are not met, Vapor might come loose and fall off. Risk of injury and incorrect output concentration.
DANGER, risk of explosion if used with combustible substances. This device is neither approved nor certified for use with combustible or explosive anesthetics (e.g. ether or cyclopropane).
WARNING! Many anesthetic agent monitors do not identify mixtures of anesthetic agents and/or do not detect that the anesthetic agent being measured differs from the agent that was set. Unusual deviations in the concentration displayed on the monitor may indicate incorrect filling.
WARNING! Make sure that the drainage valve is closed before filling Vapor. Significant quantities of anesthetic agent may escape if it is not, resulting in a serious health hazard.
WARNING! 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. Any incompatibilities are likely to result in incorrect concentrations being delivered.
WARNING!
Operating Instructions Vapor® 2000
Take care not to spill anesthetic agent. Do not inhale anesthetic agent vapor. Uncontrolled inhalation of anesthetic vapors may result in a health hazard.
WARNING! Do not use a Vapor which has been filled or partly filled with the wrong anesthetic agent or other substances. The concentration delivered may be significantly higher or lower than the concentration set on the control dial.
If the Vapor is tilted during filling, it can be overfilled. This may result in delivered concentrations being too high or too low.
WARNING! When filling during operation, always wait for 5 seconds after setting control dial to »0«. This will allow for pressure to equalize in order to prevent fresh gas and anesthetic agent vapor from escaping.
WARNING! If the connection between the filling adapter and the anesthetic agent bottle is not leak-tight, vaporizer can be overfilled and anesthetic agent vapor can escape. This may result in a health hazard.
WARNING! Excessive force may damage seal and lever mechanism, and fresh gas and anesthetic agent vapor may escape. This may result in a health hazard.
9
Important Safety Information Summary of WARNINGS and CAUTIONS
WARNING!
WARNING!
A dropped anesthetic bottle may release significant quantities of anesthetic agent, resulting in a serious health hazard.
The plug-in adapter must be level and stable on the o-ring seals. If this is not the case, there may be a loss of fresh gas, leaks, excessively low output concentrations, or the Interlock locking device may jam.
WARNING! If filling adapter has not been connected tightly enough to the anesthetic agent bottle or to the Vapor, anesthetic agent may continue to flow into the Vapor.
WARNING! If lever is not closed properly, fresh gas and anesthetic agent vapor may escape. This may result in a health hazard.
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).
WARNING! Always secure a free-standing Vapor against tilting and falling. Risk of injury and of damage to the vaporizer.
WARNING!
WARNING!
Do not store anesthetic agent bottles with their filling adapter screwed on. Anesthetic agent will escape. This may result in a health hazard.
Make sure that only one Vapor is used at any one time and that only one Vapor is connected at any one time in order to prevent delivery of mixtures of anesthetic agents or concentrations which are too high.
WARNING! If anesthetic agent bottles are not closed properly, anesthetic agent vapor will escape into the ambient atmosphere. This may result in a health hazard.
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.
WARNING! If the measured value is not within the permissible range, do not use Vapor. Risk of patient injury.
WARNING! If it is recognized that forces or torques from the magnetic field try to turn or pull the Vapor with respect to it’s normal vertical position leckage may occur. Do not use Vapor. Risk of patient injury.
WARNING! When filling Vapor with filling spout, do not allow anesthetic agent to overflow. Do not pour between inner filling funnel and housing – anesthetic agent may overflow.
WARNING! Never use Vapor within a breathing circuit. Risk of incorrect output concentration and high resistance.
10
WARNING! For operation in magnetic fields it is not permitted to connect the Vapor via hose connector or tapered connectors with the anesthesia workstation,
Operating Instructions Vapor® 2000
WARNING! Take care not to injure fingers when lowering Vapor onto its adapter.
WARNING! If it is recognized that forces or torques from the magnetic field try to turn or pull the Vapor with respect to it’s normal vertical position malfunktion of the interlock system may occur. Do not use Vapor. Risk of patient injury.
Important Safety Information Summary of WARNINGS and CAUTIONS
Precautions During Operation
WARNING! 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! If Vapors are connected in series without an Interlock system, there is a risk that several Vapors will be switched on and operational at the same time. If this happens, gas containing anesthetic agent from one Vapor would flow into the vaporizing chamber of another Vapor resulting in uncontrolled mixtures.
WARNING! High temperatures at low atmospheric pressures (high altitudes) may result in an uncontrolled excessive dosage (see page 66).
WARNING! An unsecured Vapor tilted at an angle of more than 10o may tip over. If a Vapor is operated at an angle of more than 30o, uncontrolled concentrations may occur. (see "Transport, procedure after tilting", page 58).
WARNING! CAUTION! Only use keyed filler adapters which meet the following interface requirements regarding Vapor keyed filling system: Square section with ● flat and even sealing surface ● flat and even chamfer on front end of sealing surface ● no sharp edges between chamfer and sealing surface Otherwise adapters may destroy seal of keyed filling system and/or leakage will occur. High forces trying to close the interface tightly may result in damage of the lever mechanism.
Precautions during checks of readiness for operation
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.
WARNING!
WARNING!
Vapor 19.n plug-in adapters, which are silver in color, must never be used on the Vapor 2000.
Dräger recommends use of a continuously measuring oxygen monitor with alarm system for detecting insufficient supply of oxygen, e.g. due to leaks.
WARNING! Operating Instructions Vapor® 2000
Dräger recommends monitoring concentration using a continuously measuring monitor with an alarm system to detect deviations from set concentration, leaks, or incorrect filling, particularly for Vapors with funnel filling system. For this reason, monitors should be used which can differentiate between different anesthetic agents. The capability of the monitor should be verified prior to its use.
Vapor 19.n plug-in adapters, which are grey in color, must never be used on the Vapor 2000.
WARNING! If unoccupied connectors are open, fresh gas and anesthetic agent vapor will escape and interrupt supply to the patient.
WARNING! If the corrected measured value is not within the permissible range, do not use Vapor. Risk of patient injury. Have Vapor checked by trained and factory authorized service personnel.
WARNING! A malfunctioning Interlock may endanger the patient by causing overdosing or a mixture of anesthetic agents.
11
Important Safety Information Summary of WARNINGS and CAUTIONS
WARNING!
WARNING!
If no pre-use concentration checks are performed, an incorrect concentration may be displayed.
For plug-in connectors without valves, the fresh-gas 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.
WARNING! Do not set control dial between »0« and »ON« (i.e. below 0.2 vol.%). In this range, concentration is not defined.
WARNING! Removal of Vapors with permanent connections in magnetic fields is not permitted. Ferromagnetic screws and tools and Vapors itself can be moved by magnetic attraction. Risk of injury.
WARNING! When operating an anesthesia delivery system with more than two vaporizers and Interlock S, Interlock S may not function properly when one vaporizer is disconnected.
WARNING! When using tapered connectors, disconnecting the vaporizer will disconnect the fresh gas line. Fresh gas and anesthetic agent vapor may escape.
WARNING! Abrupt movements of the Vapor or tilting the Vapor more than 30o can cause incorrect output concentration.
WARNING! Never switch off fresh gas flow before the Vapor is switched off. A Vapor must never be left switched on without a fresh gas flow, because high-concentration anesthetic vapor may leak into machine lines and ambient air, causing damage to materials and health risks.
WARNING! When Vapor is tilted at an angle of more than 30o - anesthetic agent may overflow when control dial is set at »0«. Risk of health hazard. - when control dial is set above »0«, anesthetic agent may leak and get into the flow control system causing excessively high or low concentrations when Vapor is used the next time.
WARNING!
12
Precautions during care
WARNING! Allowing liquids other than specified anesthetic agents to get into the Vapor may cause device malfunction and patient injury.
WARNING! Always follow accepted hospital procedures for handling equipment contaminated with body fluids.
Operating Instructions Vapor® 2000
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. Risk of injury. Disconnect Vapor only when control dial is set at »T«. Disconnecting the Vapor at any other control dial setting may result in incorrect output concentration and/or cause anesthetic agent vapor to escape. Place Vapor only on firm even surfaces or hang from stable brackets to prevent damage to Vapor or injuries. In magnetic fields Vapor can be moved by magnetic attraction. Risk of injury.
Important Safety Information Summary of WARNINGS and CAUTIONS
CAUTION!
WARNING!
Do not immerse Vapor or filling adapter in detergents. Do not allow detergent to penetrate under the control dial. Do not allow detergents to enter the gas inlet or outlet, or the filling system. Do not sterilize Vapor or filling adapter. Damage inside may cause incorrect output concentration. Do not use solvents on Vapor.
If the lever is not closed properly, fresh gas and anesthetic agent vapor may escape. This may result in a health hazard.
WARNING! If anesthetic agent bottles are not closed properly, anesthetic agent vapor will escape into the ambient atmosphere. This may result in a health hazard.
CAUTION! Many materials are sensitive to certain organic solvents sometimes used for cleaning and disinfecting (e.g., phenols, halogen releasing compounds, oxygen releasing compounds, strong organic acids, etc.). Exposure to such substances may cause damage that is not always immediately apparent.
WARNING! The Quik Fil drainage adapter must be flush and secure on the bottle. Otherwise significant quantities of anesthetic gas may escape.
WARNING! Precautions during shut-down
If anesthetic agent bottle is not screwed on tightly, the valve in the bottle will not open and anesthetic agent may leak during draining. This may result in a health hazard.
WARNING! Take care not to spill anesthetic agent. Do not inhale anesthetic agent vapor. Possible health risk.
WARNING! If sealing cap is not screwed on tightly, fresh gas and anesthetic agent may escape.
WARNING! Anesthetic agent which has been drained off must be handled, stored and disposed of as a drug according to institutional policy and in accordance with all federal, state, and local regulations. Failure to do so will pose a risk of administering incorrect anesthetic agents or mixtures.
Operating Instructions Vapor® 2000
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.
WARNING! Do not fill anesthetic agent bottles to the very top. This can lead to a significant amount of anesthetic agent escaping.
Precautions during storage and shipping
WARNING! Always observe permissible storage temperature range (see page 61). If the storage temperature range is exceeded, internal damage to the Vapor may occur which could cause incorrect output concentration.
WARNING! Liquid anesthetic agents and filled Vapors are subject to Hazardous Goods Regulations (under no. UN 8027 in accordance with Class 9 of IATA/ICAO). These regulations do not apply to the residues of anesthetic agents left in the wick after draining.
13
Important Safety Information Summary of WARNINGS and CAUTIONS
Precautions during maintenance
WARNING! To avoid any risk of infection, clean and disinfect Vapor before any maintenance according to established hospital procedures – this applies also when returning Vapors for repair.
WARNING! Preventive Maintenance work on Vapor 2000 anesthetic vaporizers shall be performed by trained and factory authorized staff only.
CAUTION! In case of malfunction of this device, contact your local DrägerService or our Factory Authorized Technical Service Center. The device must be inspected and serviced (preventive maintenance) by trained and factory authorized technical service representatives at regular 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.
Operating Instructions Vapor® 2000
14
Intended Use
Intended Use The Dräger Vapor®1)2000 (Vapor 2000) is a non-heated, calibrated vaporizer designed to enrich the fresh gas flow of an anesthesia delivery system with a controlled amount of anesthetic vapor.
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 tomography (MRI) together with anesthetic workstations suitable for MRI.
WARNING! Different models of this single-agent vaporizer are intended for use with one of the following agents: Isoflurane, Halothane, Enflurane, or Sevoflurane. Vapor 2000 is not intended for use with Desflurane, or for use within a breathing circuit.
CAUTION! Restriction of Distribution Federal Law and Regulations in the United States and Canada restrict this device to sale by or on the order of a physician.
WARNING!
Operating Instructions Vapor® 2000
Vapor must always be used under the supervision of qualified medical personnel in order to obtain immediate assistance in the event of a problem. The Vapor is inserted in the fresh gas line of the anesthesia delivery system which typically delivers a continuous fresh gas flow. The Vapor is connected between the fresh gas flowcontrol unit and the fresh gas outlet. The Vapor is not suitable for use in a breathing system due to high pneumatic resistance. The concentration delivered is, for the most part, not influenced by operating and ambient conditions, such as temperature, gas flow and ventilation pressure. Proper functioning of the Vapor is dependent on the direction of flow. The vaporizer must be connected and operated in accordance with the direction of flow specified on the machine. The use of the Vapor with different anesthesia delivery systems is, therefore, only permissible and safe when it is used with the appropriate special adapters. Simultaneous operation of several Vapors switched on in series is not permissible, particularly for different anesthetic agents.
For operation in magnetic fields the combination of Vapor, anesthesia workstation, and MRI- (MRT, NMR, NMI) scanner must be tested by experts (trained and factory authorized technical service representatives for anesthetic machines and MRI scanners and application experts respectively) prior the first use to ensure proper Vapor and interface function in the specific magnetic fields. Otherwise uncontrolled concentrations and/or leakage and/or malfunction of the interlocksystem may occur (see page 34). The testing has to take into consideration all positions of the anesthesia workstation including Vapor in which it will be operated in the MRI theatre during daily use. Additionally it is necessary to check if the imaging of the MRI scanner is adversely affected by the Vapor and the anesthesia workstation. Dräger recommends that the output concentration is monitored to detect any hazardous output values, using a monitor providing continuous measurement as well as upper and lower alarm limits. Installation and/or operation with anesthesia delivery systems in mobile vehicles, airplanes, helicopters and ships is only permissible after consultation and written agreement with Dräger Medical AG & Co. KGaA or Draeger Medical, Inc.
WARNING! Under no circumstances should Vapor ever be used at atmospheric pressures and temperatures at which the anesthetic agent could start to boil (see page 67), as the concentration delivered will rise and be uncontrolled.
1) Dräger Vapor® is a registered trademark of Dräger
15
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. Do not use the Vapor if it has been dropped. Damage to the Vapor may result in incorrect output concentration with the risk of serious patient injury or death.
Control dial Settings The control dial is used to switch Vapor on and off, and to set the anesthetic agent concentration. The control dial is locked when in the zero (»0«) or transport (»T«) positions and can only be adjusted by pressing the »0« button. NOTE: In this manual, all illustrations of the Vapor on an anesthesia delivery system show a stylized anesthesia delivery system in the background. All illustrations of the transport setting show only the disconnected Vapor by itself. »ON« – Switching on and adjusting concentration: Adjust concentration only when Vapor is connected to an anesthesia delivery system. 1 Press »0« button and 2 turn control dial counterclockwise to the desired anesthetic agent concentration.
1
ON
00101188
NOTE: Concentrations of more than 5 vol.% are shown in inverted form to draw attention to the risks associated with higher output concentrations and a limited flow range.
2
»0« – Switching off: When the Vapor is connected to an anesthesia delivery system and no anesthetic agent is intended to be delivered. 3 Turn control dial clockwise to »0« – »0« button engages.
16
T ON
00201188
Do not use Vapor at an angle of more than 30o, when the control dial is set at »0« or above »0«, because this may result in incorrect output concentration or cause anesthetic agent to escape from the vaporizer.
Operating Instructions Vapor® 2000
3
WARNING!
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.
3
1 Press the »0«-button and 2 Turn control dial clockwise to »T« transport setting – »0« button engages. 3 For plug-in adapter, engage locking lever in the control dial.
1 T
ON
09501188
2
WARNING! When filled, the Vapor may be transported in any position only if the control dial is set to »T«. Any other control dial setting may cause anesthetic agent to escape from the vaporizer.
Connection and Interlock Systems
Plug-in adapter/Plug-in connector This system provides for safe connection and quick change of the Vapor unit. Most plug-in connectors have valves that allow fresh gas to flow through, whether the Vapor is connected or not. These plug-in connectors can be identified by the moveable valve inserts in the inner holes on the connector pins. Many Vapors with plug-in adapters carry an anesthetic agent code on the back, which can be read and displayed by anesthesia delivery systems designed to take advantage of this identification system. 4 To connect/disconnect, the control dial must be at the »T« setting and the locking lever must be engaged in the control dial. 5 The holes in the Vapor plug-in adapter install onto the pins on the plug-in connector on the anesthesia delivery system. 6 To secure/release, swing locking lever into position and engage/disengage the pin in the control dial cap on Vapor. 7 The locking lever and pin help to ensure that the Vapor is handled correctly and that it can only be connected and disconnected when at the »T« setting.
7 6 ON
T
4
5
09601188
Operating Instructions Vapor® 2000
When the Vapor is used with different anesthesia delivery systems, different connection systems must be used. When anesthesia delivery systems have several Vapor connectors, the different Interlock systems1) ensure that only one Vapor can be used at any one time, while the others are switched off and blocked.
1) The different Interlock systems are not compatible with each other. However, the Vapor can be modified from one system to another.
17
Method of Operation Connection and Interlock Systems
00401188
Plug-in adapter DW-2000 with Interlock 2 for connecting to Dräger plug-in connectors.
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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« setting, allows only one Vapor to be in use at any one time. Illustration: left Vapor blocked, right Vapor operational.
Plug-in adapter S-2000 with Interlock S
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for connecting to Selectatec®1)-compatible plug-in connectors.
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1) Selectatec® is a registered trademark of Ohmeda.
Operating Instructions Vapor® 2000
For anesthesia delivery systems with several plug-in connectors combined with Interlock S. When a vaporizer is switched on, two pins on the side of the corresponding plug-in adapter are pushed out. These prevent other vaporizers on adjacent plug-in connectors from being switched on. Illustration: left vaporizer blocked, right Vapor operational.
Method of Operation Connection and Interlock Systems
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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. Illustration: center Vapor operational, right and left Vapors blocked Other Interlock systems, such as Interlock 1, are also in use and very similar to the Interlock NMD. Vapors with Interlock NMD may not, however, install onto these Interlock systems. 08101188
More recent versions of Narkomed anesthesia delivery systems are also available with Interlock 2 for Vapors with plug-in adapter DW-2000.
Tapered connector, 23 mm 23 mm tapered connectors conforming to ISO 5356-1 for anesthesia delivery systems with Vapors permanently mounted on rails, socalled "Cagemount". These systems do not provid an interlock function.
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Operating Instructions Vapor® 2000
1 tapered connector on Vapor
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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. Dräger recommends the use of anesthetic agent-specific filling systems to prevent incorrect filling and to reduce the volume of anesthetic agent vapor released during the filling process.
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Keyed filling system consisting of 1 the anesthetic agent-specific filling system on Vapor 2 an anesthetic agent-specific keyed filler adapter 3 the anesthetic agent specific collar and threads on the neck of the bottle. Quik Fil®1)filling system consisting of 4 the anesthetic agent-specific filling system on the Vapor 5 the anesthetic agent-specific adapter on the bottle. T
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1) Quik Fil® is a registered trademark of Abbott Laboratories
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Operating Instructions Vapor® 2000
Vapor with funnel filling system consisting of 6 a non-specific filling system on the Vapor 7 the anesthetic agent bottle. The funnel filling system does not mechanically limit the type of agent poured into the vaporizer. The color code and the name of the agent on the vaporizer specify the agent to be filled into the vaporizer. If an incorrect agent is delivered by the vaporizer, some agent monitors may not correctly identify the agent, and may also display an incorrect percentage of agent vapor. Dräger recommends using a continously measuring agent monitor with an alarm system capable of distinguishing between anesthetic agents. The capability of the monitor should be verified prior to its use.