User Manual
52 Pages
Preview
Page 1
Datum 'L' Vaporizer
Blease R
L Series
Anaesthesia Vaporizer
User Manual
Blease User Manual
1
Datum 'L' Vaporizer
2
User Manual
Datum 'L' Vaporizer
Datum 'L' Vaporizer User Manual 'L' Series Datum are smaller and lighter than other Datums. The serial number, found on the back of the vaporizer, ends with the letter 'L'
MODIFICATIONS LABEL
ECN 3573
1
ECN 3707
2
ECN 4445
3
ECN
4
ECN
5
ECN
6
ECN
7
ECN
8
ECN
9
ECN
10
V2.11/10/04 0120
Part Number: 130UM000 Issue 2/December 1999 User Manual
3
Datum 'L' Vaporizer
Read this Manual before operating the ventilator.
4
User Manual
Datum 'L' Vaporizer
Contents
Table of Contents Responsibilities of the Manufacturer ... 7 Datum Service Policy ... 7 Responsibilities of the User ... 7 Foreword ... 9 Warnings and Cautions ... 10 Importance of Patient Monitoring ... 12 Symbols and Abbreviations ... 13 1. Introduction ... 15 2. Description ... 16 2.1 Principles... 18 2.2 Concentration Control ... 20 2.3 Switching the Vaporizer ON ... 20 3. Specifications ... 21 3.1 Physical ... 21 3.2 Concentration Control ... 21 4. Filling and Draining ... 22 4.1 Standard Screw Cap Filler ... 23 4.1.1 Filling ... 23 4.1.2 Draining ... 23 4.2 Keyed Filler ... 24 4.2.1 Filling ... 24 4.2.2 Draining ... 25 4.3 Quik-fil Filler... 26 4.3.1 Filling ... 26 4.3.2 Draining ... 27 5. Installation ... 28 5.1 Cagemount Model ... 28 5.2 Selectatec Compatible Interlock Model... 29 5.3 Dragerwerk AG-Compatible Model ... 30 6. Routine Maintenance... 30 6.1 Cleaning ... 31 6.2 Draining Halothane ... 31 6.3 Checking output Concentration ... 32 6.4 Training ... 33 6.5 Pre Use Check ... 34 7. Performance ... 36 7.1 Halothane Model... 36
User Manual
5
Contents
Datum 'L' Vaporizer
7.2 Enflurane Model ... 38 7.3 Isoflurane Model ... 40 7.4 Sevoflurane Model ... 42 7.5 Temperature Compensation ... 44 7.6 Barometric Pressure ... 44 7.7 Composition of the Gas ... 46 7.8 Summary ... 46 7.8.1 Accuracy of Output ... 46 7.8.2 Gas Flow Resistance ... 46 7.9 Effects of Back-Pressure on Output ... 47 7.9.1 Steady Back-Pressure ... 47 7.9.2 Effect of IPPV on Output... 48 7.10 Gas Composition ... 48 7.10.1 Air ... 48 7.10.2 Nitrous Oxide ... 48 7.10.3 Carbon Dioxide... 48 7.10.4 Helium ... 48 8. References ... 49 8.1 General ... 49 8.2 Keyed Filler Interlock System ... 49 8.3 Trademarks and Acknowledgements... 49 9. Order Information ... 50 Index... 51
6
User Manual
Datum 'L' Vaporizer
1. Introduction
Responsibilities of the Manufacturer The manufacturer accepts responsibility for the effects on safety, reliability and performance of the equipment only if assembly operations, extensions, adjustments, modifications and repairs are carried out by persons with written authorisation from the manufacturer.
Datum® Service Policy The Blease Datum® must only be serviced by qualified service personnel. The contents of this manual are not binding. If any significant difference is found between the product and this manual please contact Blease for further information. The Blease Datum® is designed to function reliably without the inconvenience of an expensive regular maintenance schedule. In communication with Blease, quote the model and serial number of the equipment, with the approximate date of purchase. If the unit is being returned for repair, indicate the nature of the fault or the work you require to be carried out. Contact the Company to obtain a Goods Return Number (GRN) prior to returning the product. This is to ensure traceability and to speed the return following repair. Isoflurane, Enflurane and Sevoflurane vaporizers require a full service after 10 years. Halothane vaporizers require a full service after 5 years.
Responsibilities of the User The Blease Datum® vaporizer conforms with the specifications and operating procedures described in this manual and on any accompanying notices and labels only if it has been installed, used and maintained in accordance with the instructions. The safe function of the vaporizer can only be guaranteed if it is regularly checked and serviced at or in excess of the standards specified in this manual. If the vaporizer is suspected of being worn, defective or otherwise unfit for use, it should under no circumstances be used.
User Manual
7
Datum 'L' Vaporizer Broken, worn, missing or contaminated components must be replaced immediately; contact the Blease distributor from whom the vaporizer was obtained for further service advice. Contact: Blease Beech House Chiltern Court Asheridge Road Chesham Buckinghamshire HP5 2PY England Tel: 01494 784422 Fax: 01494 791497 Copyright © 1993, 1994, 1995, 1996, 1999, 2001 Blease Medical Equipment Ltd. All rights reserved. The information contained in this publication may not be used for any other purpose than that for which it was originally supplied. This publication may not be reproduced in part or in whole without the written consent of Blease Medical Equipment Limited.
8
User Manual
Datum 'L' Vaporizer
Foreword This manual contains all appropriate information concerning the use, function, performance and maintenance of the Blease Datum® vaporizer. Blease Medical has a policy of continued product improvement and therefore reserves the right to make changes which may affect the information contained in the manual without giving prior notice. Read this manual before operating the vaporizer. The user must be familiar with the machine and its various functions before using it on a patient. The terminology in this manual complies with ISO4135, Anaesthetic Apparatus Terminology. The following symbols are used in this manual in addition to those specified above: %Vol - volumetric percentage. A method of expressing the concentration of a vapour in order to compare it with the concentration of a true gas. 100%Vol is equivalent to 100% partial pressure in a mixture. WARNING: There is danger of personal injury to the user or the patient.
Caution: There is danger of damage to the vaporizer or other equipment.
Note: Further relevant or helpful information.
User Manual
9
Datum 'L' Vaporizer
Warnings and Cautions The following statements are made to comply with the requirements of IEC 60601-1. 1.
This device may be sold to, and used on the order of, a medically qualified practitioner only.
2.
This vaporizer is designed for use with one anaesthetic agent only, which is that named on the filler. Incorrect dosage may result if the wrong drug is used in this vaporizer. National and international standards are provided for by the keyed filler version of this vaporizer.
3.
The anaesthetic agent is named on the filler according to BP, USP or Ph EUR. It is the user's responsibility to ensure that the trade name of a drug is equivalent to that used in the appropriate pharmacopoeia.
4.
The vaporizer must be secured in the upright position before it is connected to a patient and a leak test performed. Excess dosage may be delivered if the vaporizer is moved suddenly during use.
5.
In the interests of health and safety it is recommended that the vaporizer be drained prior to transportation. The concentration control must be set to zero if the vaporizer is transported when filled. The vaporizer must be secured in the upright position for at least one hour before it is connected to a breathing system. It should then be flushed at 4 l/min for two minutes before being connected to a patient. Excess dosage may be delivered if adequate time is not allowed for the liquid to return to its normal level. If the vaporizer has been transported with the concentration control at any position other than zero contact the Blease Service Department or an authorized engineer for advice.
10
User Manual
Datum 'L' Vaporizer 6.
Anaesthetic agents are poisonous; great care must be taken to avoid the spilling of an agent during filling or drainage to prevent the hazard of prolonged inhalation of trace concentrations from the atmosphere. Expired anaesthetic gases should be extracted from the operating theatre by an approved anaesthetic gas scavenging system.
7.
The concentration control must be set to zero during the draining or filling process. The delivered concentration will be incorrect when the filler port is open. The vaporizer must be secured in the upright position during filling in order to prevent overfilling.
8.
Do not overfill the vaporizer. If it is overfilled, it must be withdrawn from use and the Blease Service Department or an authorized engineer contacted for advice.
9.
While in use, check frequently that the liquid level is between the minimum and maximum marks on the level indicator.
10.
The vaporizer may cease to function correctly if it is exposed to excessive temperatures as the temperature compensation device may be damaged. The vaporizer should be stored between -20oC and 50oC (-5oF and 122oF).
11.
The output of the vaporizer is affected by barometric pressure, and it may be necessary to use a correction factor when analysing the output, especially at high altitudes >1500 metres (See 7.6) The barometric pressure is not normally of clinical significance. All Blease vaporizers are calibrated at sea level.
12.
User Manual
Anaesthetic agents must be treated as pharmaceutical products; liquid must never be drained into an open container and reused in case of contamination. The liquid must always be disposed of as a hazardous chemical.
11
Datum 'L' Vaporizer 13.
The vaporizer must never be modified or dismantled by any unauthorised person, but should be serviced at the prescribed intervals by a Blease Service engineer or Agent, or a trained technician, and no-one else.
14.
The vaporizer must be connected so that the flow of gas to the patient is as indicated by the arrows on the device. The delivered concentration will be incorrect if the flow is reversed.
15.
The Blease Datum® ® vaporizer has a relatively high flow resistance and must not be incorporated in a breathing system downstream of the common gas outlet.
16.
Before use, all joints must be checked for leaks and the backbar function tests must be performed as described in the anaesthetic machine User Manual.
17.
If the vaporizer is fitted with a Selectatec ® or interlocking Cage- mount manifold, the interlock function is void if used with a non-interlock device.
Importance of Patient Monitoring Anaesthesia systems have the capability to deliver mixtures of gases and vapours to the patient which could cause injury or death unless controlled by a qualified anaesthetist. There can be considerable variation in the effect of anaesthetic drugs on individual patients so that the setting and observation of control levels on the anaesthesia system does not in itself ensure total patient safety. Anaesthesia system monitors and patient monitors are very desirable aids for the anaesthetist but are not true clinical monitors as the condition of the patient is also dependant on his respiration and the functioning of his cardiovascular system. WARNING: It is essential that these elements are monitored frequently and regularly and that any observations are given precedence over machine control parameters in judging the state of a clinical procedure.
12
User Manual
Datum 'L' Vaporizer
Symbols and abbreviations used on Blease Equipment
User Manual
13
Datum 'L' Vaporizer
Notes
14
User Manual
Datum 'L' Vaporizer
1 Introduction The Blease Datum® Vaporizer is intended for use in the fresh gas supply of a continuous flow anaesthetic machine. It should be connected between the flowmeters and the common gas outlet. Because of the high internal resistance, the vaporizer is unsuitable for use in a breathing system. The Blease Datum® Vaporizer provides accurate concentrations of anaesthetic gases in the fresh gas supply; the concentration is specified using a dial on the front of the vaporizer. The fresh gas supply should be between 0.5 and 15 l/m.
User Manual
15
Datum 'L' Vaporizer
2 Description Cagemount Model Key Filler Version
Key A Inlet connector B Outlet connector C Concentration control D Filler port clamp E Filler valve control knob F Level indicator L Filler port The sight glass markings at F on this diagram are shown as a filled triangle for the Maximum Liquid Level and an empty triangle for the Minimum Liquid Level.
16
User Manual
Datum 'L' Vaporizer
Selectatec® compatible Interlock Model Standard Version
Key C Concentration control F Level indicator G Interlock pins (Selectatec® only) H Locking knob K Drain plug V Filler cap W Drain screw The sight glass markings at F on this diagram are shown as a filled triangle for the Maximum Liquid Level and an empty triangle for the Minimum Liquid Level.
User Manual
17
Datum 'L' Vaporizer
2.1
Principles
Key A Inlet connector B Outlet connector C Concentration control K Anaesthetic drug in liquid form L Vapour chamber M Wick (IPPV coil)
18
User Manual
Datum 'L' Vaporizer
WARNING: The Blease Datum® Vaporizer is designed and tested for use only with the drug specified on the front panel. The chamber contains the anaesthetic drug in liquid form K, and the wick M and N ensures that the upper part of the chamber remains filled with a saturated vapour of the drug. As the vapour is many times more concentrated than required for clinical use, a concentration control C regulates the gas flow through the vapour control valve P, the bypass valve R and vapour chamber to produce the required concentration. When the control is set to zero the bypass remains open; however, the vapour chamber is completely isolated from the patient gas flow. When the control is set to the desired concentration, valve S opens allowing flow into the vapour chamber. The temperature-compensating device T varies the dilution ratio provided by the concentration control and bypass passage R so that the output concentration remains substantially constant irrespective of temperature. The vaporizer may be fitted with a screw-cap filler, a Quik-Fil® filler, or a keyed filler.
User Manual
19
Datum 'L' Vaporizer
2.2 Concentration Control The concentration control C regulates the concentration of delivered vapour. The dial automatically locks at the zero position when turned to off, and must be pushed inwards and rotated counterclockwise to set a concentration according to the graduations on the dial.
2.3 Switching the Vaporizer On WARNING: Never attempt to switch on the vaporizer without checking that it is fully locked on to the manifold.
20
1.
Push in the dial and rotate it counterclockwise to the desired concentration, as indicated by the markings on the control knob.
2.
When the vaporizer is not in use, the control should be turned to the zero position to prevent any delivery of vapour.
User Manual