BleaseDatum User Manual Rev C Aug 2011

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Blease Datum® User Manual

Blease Datum® Vaporizers User Manual Modifications Label ECO A PR023022

ECO B PR024135

ECO C PR024600

ECO D

ECO E

ECO F

ECO G

ECO H

ECO I

ECO J

Spacelabs Healthcare Ltd. (Anesthesia Delivery and Ventilation Division) 1 Harforde Court • John Tate Road • Hertford • SG13 7NW • United Kingdom Tel: Fax:

+44 (0)1992 507700 +44 (0)1992 501213

e-mail (enquiries): [email protected] e-mail (technical): [email protected] www.spacelabshealthcare.com

Part Number: 073-0228-00 Rev. C/ August 2011

This user manual applies to the BleaseDatum® vaporizers, which are identified by the serial number located on the back of the vaporizer.

Blease Datum® User Manual

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Read this User Manual before you operate the anesthesia machine!

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Blease Datum® User Manual

Table of Contents

Table of Contents Preface ... 8 Responsibilites of Manufacturer ...8 BleaseDatum Service Policy ...8 Responsibilities of User ...8 Contact Information ...9 Safety Summary ...11 Symbols & Abbreviations ...14

1 - Introduction ... 15 2 - Vaporizer Description ... 16 Selectatec® Compatible Interlock Model Standard Version ...16 Cagemount Model Key Filler Version ...17 Principles of Operation ...18 Concentration Control ...19 Switching On the Vaporizer ...20

3 - Specifications ... 21 Physical ...21 Concentration Control ...21 Halothane, Isoflurane and Enflurane Models ...21 8% Sevoflurane models ...21

4 - Filling and Draining a Vaporizer... 22 Standard Screw Cap Fill Vaporizers ...23 Filling the Vaporizer ...23 Draining the Vaporizer ...23 Key Fill Vaporizers ...24 Filling the Vaporizer ...24 Draining the Vaporizer ...25 Quik-Fil Vaporizers ...26 Filling the Vaporizer ...26 Draining the Vaporizer ...27

5 - Install the Vaporizers ... 29 Install the Cagemount Model Vaporizers ...29 Install the Selectatec®-Compatible Interlock Model ...30

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Table of Contents Remove the Selectatec®-Compatible Interlock Model ...31 Install the Drägerwerk® AG-Compatible Model ...31

6 - Routine Care ... 32 Cleaning ...32 Draining Halothane ...32 Verify Output Concentration ...33 Service Training ...34 Pre-Use Check ...35

7 - Performance ... 36 The Halothane Model ...36 The Enflurane Model ...38 The Isoflurane Model ...40 The Sevoflurane Model ...42 Temperature Compensation ...44 Barometric Pressure ...44 Composition of the Gas ...45 Summary ...46 Accuracy of Output ...46 Gas Flow Resistance ...46 Effects of Back-Pressures on Output ...47 Steady Back-Pressure ...47 Effect of IPPV on Output ...47 Gas Composition ...48 Oxygen ...48 Nitrous Oxide ...48 Carbon Dioxide ...48 Helium ...48

8 - References ... 49 General ...49 Keyed Filler Interlock System ...49 Trademarks and Acknowledgements ...49

9 - Part Numbers ... 50

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Blease Datum® User Manual

List of Figures

List of Figures Figure 1: Selectatec Compatible Interlock Model, Standard Version ...16 Figure 2: Cagemount Model Key Filler ...17 Figure 3: Vaporizer Components ...18 Figure 4 - Fill the Vaporizer ...26 Figure 5 - Air Return Bubbles ...26 Figure 6 - Remove the Cap ...27 Figure 7 - Align the Drain Funnel ...27 Figure 8 - Attach the Drain Funnel...27 Figure 9 - Remove the Drain Plug ...28 Figure 10 - Effect of Flowrate on Halothane Output ...36 Figure 11 - Effect of Temperature on Halothane Output ...37 Figure 12 - Effect of Flowrate on Enflurane Output ...38 Figure 13 - Effect of Temperature on Enflurane Output...39 Figure 14 - Effect of Flowrate on Isoflurane Output...40 Figure 15 - Effect of Temperature on Isoflurane Output ...41 Figure 16 - Effect of Flowrate on Sevoflurane Output ...42 Figure 17 - Effect of Temperature on Sevoflurane Output ...43 Figure 18 - Effect of Altitude on Output ...45

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Preface

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 personnel with written authorization from the manufacturer.

BleaseDatum® Service Policy The BleaseDatum® vaporizers must only be serviced by qualified Global Technical Support personnel. The contents of this manual are not binding. If any significant difference is found between the product and this manual, please contact Spacelabs Healthcare. The BleaseDatum® is designed to function reliably without the inconvenience of an expensive regular maintenance schedule. Isoflurane, Enflurane and Sevoflurane vaporizers require full service after 10 years. Halothane vaporizers require full service after 5 years. Replace broken, worn, missing or contaminated components immediately. Contact your Spacelabs Healthcare representative for assistance.

Responsibilities of the User The BleaseDatum® 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, do not use it under any circumstances. For all communications with Spacelabs Healthcare, quote the model and serial number of the equipment, with the approximate date of purchase. If the equipment is being returned for repair, indicate the nature of the fault or the work you require to be performed. 8

Blease Datum® User Manual

Preface

Contact Information Spacelabs Healthcare Inc. (Company Headquarters) 5150 220th Ave. SE Issaquah, WA 98029 USA Tel: Fax:

+1 425-657-7200 +1 425-657-7212

in North America: +1 800-522-7025

Spacelabs Healthcare Ltd. (Anesthesia Delivery and Ventilation Division) 1 Harforde Court John Tate Road, Hertford SG13 7NW United Kingdom Tel: Fax:

+44 (0)1992 507700 +44 (0)1992 501213

e-mail (enquiries): [email protected] e-mail (technical): [email protected] www.spacelabshealthcare.com

Copyright ©2011, Spacelabs Healthcare Ltd, Anesthesia Delivery and Ventilation Division. All rights reserved. The information contained in this publication may not be used for any other purpose than that for which it was originally intended. This publication may not be reproduced in part or in whole without the written consent of Spacelabs Healthcare.

CE Marking The product is labeled with the CE mark and notified body number.

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Preface

About This Manual This manual contains all appropriate information concerning the use, function, performance and maintenance of BleaseDatum® vaporizers. Spacelabs Healthcare 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, Anesthetic Apparatus Terminology.

Safety Notices The following symbols are used in this manual to alert you to potential hazards. Be sure to read all of the Warnings and Cautions listed in the Safety Summary section before using the BleaseDatum® Vaporizer with your anesthesia machine. Warning Notices Warning notices denote a potential hazard to the health and safety of users and/or patients. These notices clearly state the nature of the respective hazard and the means by which it can be avoided. Warning notices appear in full in the preliminary pages and are repeated at their points of application in the manual. Caution Notices Cautionary notices denote a potential hazard to the physical integrity of equipment/software but NOT a danger to personnel. These notices clearly state the nature of the hazard and the means by which it can be avoided. Notes This symbol indicates information that is relevant or helpful to the user. 10

Blease Datum® User Manual

Safety Summary

Safety Summary The following statements are made to comply with the requirements of IEC 60601-1 and ISO 8835-4. 1.

Federal law restricts the sale of this device by or on the order of a licensed physician.

2.

This device may be sold to and used on the order of a medically qualified practitioner only.

3.

While the vaporizer is in use, an anesthetic agent monitor complying with ISO 11196 must be used.

4.

Datum vaporizers are intended for use with machines equipped with an anesthetic gas scavenging transfer and receiving system in accordance with ISO 8835-3.

5.

Each vaporizer is designed for use with one anesthetic agent only, which is identified on the filler. • Incorrect dosage may result if the wrong drug is used in the vaporizer. • National and international standards are provided for by the keyed filler version of this vaporizer.

6.

The anesthetic 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.

7.

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.

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Safety Summary 8.

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 while 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 Spacelabs Healthcare Global Technical Support for assistance.

9.

Anesthetic agents are poisonous. Take great care 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 anesthetic gases should be extracted from the operating theatre by an approved anesthetic gas scavenging system.

10. 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. 11. Do not overfill the vaporizer. If it is overfilled, you must remove it from use. Contact Spacelabs Healthcare Global Technical Support for advice. 12. While the vaporizer is in use, check frequently that the liquid level is between the minimum and maximum marks on the level indicator. 13. The vaporizer may not function correctly if it is exposed to excessive temperatures as the temperature compensation device may be damaged. Store the vaporizer between -20°C and 50°C (-5°F and 122°F). 14. The output of the vaporizer is affected by barometric pressure, and it may be necessary to use a correction factor when analyzing the output, especially at high altitudes [>1500 meters] (See section 7). The barometric pressure is not normally of clinical significance. All BleaseDatum® vaporizers are calibrated at sea level. 12

Blease Datum® User Manual

Safety Summary 15. Anesthetic 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. 16. The vaporizer must never be modified or dismantled by any unauthorized person, but should be serviced at the prescribed intervals by a qualified Spacelabs Healthcare Global Technical Support representative only. 17. The vaporizer must be connected so that the flow of gas to the patient is oriented as indicated by the arrows on the device. The delivered concentration will be incorrect if the flow is reversed. 18. The BleaseDatum® vaporizer has a relatively high flow resistance and must not be incorporated in a breathing system downstream of the common gas outlet. 19. Before use, check all connections for leaks and perform the backbar function tests as described in the user manual for the anesthesia machine. 20. If the vaporizer is fitted with a Selectatec®, Dräger or interlocking Cagemount manifold, the interlock function is void if used with a noninterlock device.

Importance of Patient Monitoring Anesthesia systems have the capability to deliver mixtures of gases and vapors to the patient which could cause injury or death unless controlled by a qualified anesthetist. There can be considerable variation in the effect of anesthetic drugs on individual patients so that the setting and observation of control levels on the anesthesia system does not in itself ensure total patient safety. Always ensure the use of appropriate patient monitoring and agent analysis whenever posssible. It is essential that respiration and cardiac function are monitored frequently and regularly and that any observations are given precedence over machine controls.

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Symbols & Abbreviations Gauge pressure expressed in centimetres of water

Confers approval under the European Medical Device Directive and the notified body number

O2

Oxygen

Caution

CO2

Carbon Dioxide

Caution: Attention, see instructions for use

L/pm

liters per minute

WARNING: There is danger of personal injury to the user or patient

ml

milliliter

Further relevant or helpful information

psi

pounds per square inch

Unlocked

kPa

Kilopascals

Locked

mBar

millibars

Federal law restricts this device for sale by or on the order of a physician.

%Vol.

Percent concentration of agent per total volume

Filling

Date of Manufacture

Push in to turn

Manufacturer

Do not tip when charged

cmH2O

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Blease Datum® User Manual

1 - Introduction

1 - Introduction The BleaseDatum® Vaporizer is intended for use in the fresh gas supply of a continuous flow anesthesia 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 BleaseDatum® Vaporizer provides accurate concentrations of anesthetic 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 L/min and 15 L/min. Please consult the instructions for use of the specific agent for appropriate flow rate information. Certain agents are not recommended for use at flow rates below 2 L/min.

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2 - Vaporizer Description

2 - Vaporizer Descriptions Selectatec® Compatible Interlock Model Standard Version

Figure 1 Key C

Concentration Control

F

Level Indicator

G

Interlock Pins

H

Locking Valve

K

Drain Plug

V

Filler Cap

W

Drain Screw

Figure 1: Selectatec Compatible Interlock Model, Standard Version

The sight glass markings at F in Figure 1 are shown as a filled triangle for the Maximum Liquid Level and an empty triangle for the Minimum Liquid Level.

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Blease Datum® User Manual

2 - Vaporizer Description

Cagemount Model Key Filler Version

Figure 2 Key A

Inlet Connector

B

Outlet Connector

C

Concentration Control

D

Filler Port Clamp

E

Filler Valve Control

F

Level Indicator

L

Filler Port

Figure 2: Cagemount Model Key Filler

The sight glass markings at F in Figure 2 are shown as a filled triangle for the Maximum Liquid Level and an empty triangle for the Minimum Liquid Level.

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2 - Vaporizer Description

Principles of Operation

Figure 3 Key A

Inlet Connector

B

Outlet Connector

C

Concentration Control

K

Anesthetic Drug in Liquid Form

L

Vapor Chamber

M

Wick (IPPV Coil)

Figure 3: Vaporizer Components

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Blease Datum® User Manual

2 - Vaporizer Description The Blease Datum® Vaporizer is designed and tested for use only with the drug specified on the front panel.

Refer to Figure 3 as you read this section. The vapor chamber contains the anesthetic drug in liquid form K, and the wick M and N ensures that the upper part of the chamber remains filled with a saturated vapor of the drug. As the vapor is many times more concentrated than required for clinical use, a concentration control C regulates the gas flow through the vapor control valve P, the bypass valve R and vapor chamber to produce the required concentration. When the control is set to zero, the bypass remains open; however, the vapor 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 vapor 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.

Concentration Control The concentration control C regulates the concentration of delivered vapor. 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.

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2 - Vaporizer Description

Switching On the Vaporizer Always verify that the vaporizer is locked onto the manifold before you switch on the vaporizer. 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 vapor.

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Blease Datum® User Manual