Delta User Comp - Frank's Hospital Workshopfrankshospitalworkshop.com/equipment/documents...Sigma...

Sigma Delta VaporizerUser Instruction Manual

Quality and Assurance in Anaesthesia

This manual containscalibration and servicerecords for Sigma DeltaVaporizer, Serial No.

. . . . . . . . . . . . . . . . . . . .

Keep this manual withthe vaporizer at all times

WARNING

Anaesthetic systems have thecapability to deliver mixtures ofgases and vapours to the patientwhich could cause injury ordeath unless controlled by aqualified anaesthetist.

There can be considerablevariation in the effect ofanaesthetic drugs on individualpatients so that the setting andobservation of control levels onthe anaesthesia systems doesnot in itself ensure total patientsafety.Anaesthesia system monitorsand patient monitors are verydesirable aids for theanaesthetist but are not trueclinical monitors as thecondition of the patient is alsodependent on his respirationand the functioning of hiscardio-vascular system.

IT IS ESSENTIAL THAT THESEELEMENTS ARE MONITOREDFREQUENTLY AND REGULARLYAND THAT ANY OBSERVATIONSARE GIVEN PRECEDENCEOVER MACHINE CONTROLPARAMETERS IN JUDGING THESTATE OF A CLINICALPROCEDURE.

Servicing and Repairs

In order to ensure the fulloperational life of the Sigma Deltavaporizer, we recommend that aperiodic service check should beperformed by a Penlon trainedengineer. This check comprises avaporizer CALIBRATION CHECKand LEAK CHECK.Note:(a) The calibration check must beperformed using a suitable agentanalyser, e.g. a Rikenrefractometer or infrared analyser.(b) The service check is part of therecommended pre-use check foryour Anaesthesia System.

Should the calibration check showthe unit to be outside the specified performance requirement (seesection 11) then a service must beperformed.

This may be done on site by:(a) A trained user.(b) An authorised Penlon

agent.(c) A Penlon service engineer.

A calibration and service recordsection is provided to maintain arecord of the vaporizer'sperformance.

For any enquiry regarding theservice or repair of this vaporizer,contact the nearest accreditedPenlon agent* or contact theService Department at PenlonLimited.

*Agent's name and address:

Service and Repair DepartmentPenlon LtdAbingdonOX14 3PHUKTel: +44 (0) 1235 547063Fax: +44 (0) 1235 547062E-mail: [email protected]

Always give as much of thefollowing information as possible:1. Type of equipment2. Product name3. Serial number4. Approximate date of

purchase5. Apparent fault

(i)

IMPORTANT

This manual has been produced toprovide authorised personnel withinformation on the function, routineperformance and maintenancechecks, applicable to the PenlonSigma Delta vaporizer.Information contained in themanual is correct at the date ofpublication. The policy of PenlonLimited is one of continuedimprovement to its products.Because of this policy PenlonLimited reserves the right to makeany changes, which may affectinstructions in this manual, withoutgiving prior notice.Personnel must make themselvesfamiliar with the contents of thismanual before using the vaporizer.

TerminologyThis manual complies with ISO4135, Anaesthetic ApparatusTerminology.The following additional definitionsshould be noted:

Vol.% - shortened form ofvolumetric percentage.The commonly used method ofexpressing vapour concentrationsso that they can be compared withconcentrations of true gases.100 Vol.% is equivalent to 100%partial pressure in a mixture.

Copyright © Penlon Ltd, 2002.All rights reserved.

(ii)

FOREWORD

USER RESPONSIBILITY 11. WARNINGS AND CAUTIONS 22. PURPOSE 7

3. DESCRIPTION3.1 Operating Principles 83.2 Controls 8

4. SPECIFICATION4.1 Physical Dimensions 104.2 Weight 104.3 Capacity 104.4 Filling System 104.5 Concentration Control Dial Scale 114.6 Patents 114.7 Temperature Range 114.8 Flow Range 114.9 Pressure Range 11

5. FILLING AND DRAINING5.1 Key Filler System 125.2 Screw Cap (Pour Fill) System 155.3 Quik-Fil Filling System 18

6. INSTALLATION6.1 Gas Port Transit Seals 216.2 Selectatec Compatible Models (with interlock) 21 6.3 Cagemount (23 mm) Taper Models 236.4 Penlon Off-line System (Mk.2 and Mk.3) 24 6.5 Drager 'Plug-in' Compatible 256.6 North American Drager Compatible 266.7 Pre-Use Checklist - All Models 27

7. PERFORMANCE CHARACTERISTICS7.1 Performance Graphs 287.1.1 Halothane Models 297.1.2 Enflurane Models 307.1.3 Isoflurane Models 317.1.4 Sevoflurane Models 327.2 Temperature Compensation 33

CONTENTS

(iii)

7.3 Pressure Effects 337.3.1 Ambient Pressure 337.3.2 Back Pressure 337.3.3 Intermittent Back Pressure 337.4 Summary of Performance Specifications 347.4.1 Factors Affecting Output Accuracy 347.4.2 Resistance to Gas Flow 357.5 Effect of IPPV on Output 357.6 Effect of Gas Composition on Output 357.7 Output when Control is at 0 (Zero) 357.8 Effect of Flush Valve Operation 36

8. USER MAINTENANCE8.1 Servicing 378.2 Cleaning 388.3 Draining - Halothane Models 388.4 Checking Vaporizer Output 388.5 Training Course 398.6 Returning the Vaporizer for Service or Repair 39

9. REFERENCES 40

10. ORDERING INFORMATION 41

11. SERVICE RECORDS11.1 Service Policy 4211.2 Calibration Procedure using the Riken Analyser 43 11.3 Servicing and Repair Details 4611.4 Calibration Check 50

CONTENTS

(iv)

This vaporizer has been built toconform with the specification andoperating procedures stated in thismanual and/or accompanyinglabels and notices when checked.assembled, operated, maintainedand serviced in accordance withthese instructions provided. To ensure the safety of thisvaporizer it must be checked andserviced to at least the minimumstandards laid out in this manual. A defective or suspected defective,product must not, under anycircumstances be used.

The user must accept responsibilityfor any malfunction which resultsfrom non-compliance with theservicing requirements detailed insection 8.1.

Worn, broken, d i s t o r t e d ,contaminated or missingcomponents must be replacedimmediately. Should such a repairbecome necessary it isrecommended that a request forservice advice is made to thenearest Penlon service centre.

This vaporizer and any of itsconstituent parts must be repairedonly in accordance with writteninstructions issued by PenlonLimited, and must not be altered ormodified in any way without thewritten approval of Penlon Limited. The user of this equipment shallhave the responsibility for any

malfunction which results fromimproper use, maintenance, repair,damage or alteration by anyoneother than Penlon Limited or itsappointed agents.

This vaporizer must only besupplied to, and used by, suitablyqualified medical practitioners. In the USA and Canada:Caution: Federal Law restricts thisdevice to sale by or on the order ofa physician.

Statements in this manualpreceded by the following wordsare of special significance.

WARNING - means there is apossibility of personal injury toyourself or others.

CAUTION - means there is apossibility of damage to theinstrument or other property.

NOTE - indicates points ofparticular interest for more efficientand convenient operation.

The reader must take particularnotice of the warnings, cautions.and notes printed throughout themanual.

USER RESPONSIBILITY

1

The following Warnings andCautions must be read andunderstood before using thisvaporizer

WARNINGSGeneral Information

1. The user must read andbe familiar with thecontents of thisinstruction manual beforeusing the vaporizer

2. The vaporizer is designedfor use only with thespecific anaesthetic agentnamed on the filler block(and further indicated bycolour coded labelling).Misdosage may occur ifthe vaporizer is filled withthe wrong drug.Agent specific (keyed)filler devices are providedon certain models to meetnational and internationalstandards.(See section 9 forstandards).

3. The pharmacopoeia nameof the drug is used on thelabel according to BP,USP, or Ph EUR. The user is responsiblefor confirming that anytrade name of a drug isequivalent to theregistered name.

4 This vaporizer must notbe modified ordisassembled by anunauthorised person. Itshould be regularlyserviced by a Penlon-authorised service agent,trained technician orengineer and by no otherperson.(see section 8)

5. Vaporizers maymalfunction if exposed toexcessively hightemperatures, e.g. bystorage above a radiator.This may affect thecalibration.

Maximum storage

temperature: 50oC (122oF)

Minimum storage

temperature: -20oC (-5oF)

Operating temperature

range: 15 to 35oC

(58 to 95oF)

Before use, function testany vaporizer that hasbeen subjected totemperatures near theupper/lower limits givenabove.

1. WARNINGS AND CAUTIONS

2

Filling and draining thevaporizer

6. The filler system must bemaintained in accordancewith the instructionsgiven in the UserMaintenance section.

7. The vaporizer must befilled only by suitablyskilled and trainedpersonnel.

8. Anaesthetic drugs arepoisonous and there isevidence that there is ahealth hazard topersonnel due toprolonged inhalation oftrace concentration in theatmosphere. Care mustbe taken to avoid spillageof anaesthetic drugswhen filling or drainingvaporizers.

9. The vaporizer controlmust be in the 0 (zero)position during the fillingor draining process.Overfilling and/or spillingmay occur if the control isnot in the 0 (zero)position.Provided the control is inthe 0 (zero) position, gasmay continue to bedelivered from theanaesthetic machine to

the patient during thefilling procedure.

10. The vaporizer must beupright during filling tominimise the risk ofoverfilling.

11. Do not use theanaesthetic agent bottleto fill the vaporizer if thebottle is cracked or thefiller connector is loose orbroken. This may result inoverfilling orcontaminated agententering the vaporizer.

12. If a new bottle ofanaesthetic agent is to beused, check that thetamper-evident shrinkband is undamaged.

13. Ensure that the drain plugscrew, located on thelower front of thevaporizer, is correctlytightened to prevent lossof liquid agent.

14. Do not tamper with thefilling system valve. Thismay cause a vapour andfresh gas leak.Anaesthesia systemmonitors and patientmonitors are verydesirable aids for the

WARNINGS AND CAUTIONS

3

anaesthetist but are nottrue clinical monitors asthe condition of thepatient is also dependenton his respiration and thefunctioning of hiscardiovascular system.

15. Do not overfill. A vaporizer that has beenoverfilled must bewithdrawn from use.

Contact the ServiceDepartment at Penlon foradvice.

16. Anaesthetic drugs mustbe treated as apharmaceutical product.Liquid should never bedrained from a vaporizerinto an open containerand then reused.Contamination is likely.Always dispose of suchdrained liquid as ahazardous chemical.

17. After filling or draining:

Pour Fill (Screw cap) filler- always refit andretighten the filler cap.

Key (agent specific) fillermodels - always tightenthe filler control.In addition, on key fillersystems, always refit thekey filler plug and tighten

the clamp screw beforeusing the vaporizer. Thevaporizer will leak if thisis not done.

Quik-Fil models - removethe bottle and refit thefiller block cap beforeusing the vaporizer.

Delivered concentrationsare inaccurate while thefiller port is open.

Before using the vaporizer

18. Do not use the vaporizer ifthe agent level is notvisible in the sight glassor the level is outside ofthe Max - Min indicator.

19. If a vaporizer istransported when filledwith liquid drug thecontrol must be in the 0(zero) position duringtransport and a period ofat least ten minutes in asecured upright positionmust elapse beforeconnection to ananaesthetic breathingsystem.

Movement duringtransport can result inover-dosage unless timeis allowed for drainage ofliquid to the normal


4

position.If a vaporizer has beentransported with thecontrol in the openposition it must beflushed at 5 L/min for tenminutes before clinicaluse on a patient

20. The vaporizer must not betipped over or inverted.

If the vaporizer has beentipped over or inverted itmust be set to maximumoutput and flushed at 5 L/min for ten minutesbefore clinical use on apatient.

21. The vaporizer must besecurely fixed and in anupright position beforeconnection to a patient.There is a danger ofoverdosage if suddeninadvertent movementoccurs during use.

22. Anaesthetic machinedesigns are constantlyevolving, and new modelsmay differ dimensionallyfrom existing equipment.It is the user'sresponsibility to ensurethat the configuration ofthe anaesthetic machineallows correct installationof the vaporizer.There must be sufficientclearance between the

selectatec manifold andthe rear frame panellingof the machine to allowthe vaporizer connectorblock to seal correctly onthe manifold.

23. Before use test all jointsfor gas tightness, andperform back bar functiontests as detailed in theanaesthetic machine usermanual.

Using the vaporizer

24. Check the liquid levelfrequently when using thevaporizer and maintainthe level between the min.and max. marks.The vaporizer controlmust be in the zero (0)position during the fillingprocess (see warning 7).

25. Vaporizer outputs aresensitive to barometricpressure. A correction factor maybe necessary whenassessing the outputusing an analyser, forexample at high altitude.

Barometric pressureeffects are not usually ofclinical importance. (seesection 7.3).


5

26. The vaporizer is a flowdirection-sensitive apparatusand the direction of gas flowtowards the patient must beas indicated by the arrow onthe top label.Reversal of flow may causeinaccuracies of deliveredconcentration.

27. The vaporizer must not beused downstream of thecommon gas outlet.

28. As stated in section 2, thevaporizer is of relatively highresistance and must not beincorporated within abreathing system.

29. Expired anaesthetic vapoursshould be extracted from thetheatre by an anaestheticgas scavenging system.(see section 9 forstandards.)

30. Do not use the vaporizerwith flammable anaesthetics.

User Maintenance

31. Do not pour water, or anycleaning solutions into thevaporizer.

CAUTIONS1 Anaesthetic machine and

workstation standardsrequire that means beprovided to ensure that gascannot pass through morethan one vaporizerchamber.Vaporizers without interlockdevices or systems mustonly be used on machineswhich only have onevaporizer mounting station.


6

The Sigma Delta vaporizer isdesigned for incorporation in thefresh gas supply system ofcontinuous flow anaestheticmachines, directly connectedbetween the flowmeter unit and thecommon gas outlet of the machine.

The vaporizer is unsuitable for usewithin a breathing system 'in circuit'because of the relatively highinternal resistance.

Its purpose is the provision ofaccurate concentrations ofanaesthetic drugs in the fresh gassupply, in accordance with thesetting of the control dial, when thefresh gas supply flow is between0.2 and 15 litres/min. Refer to section 7 (PerformanceCharacteristics), which shows theextent of modifications to thecontrol calibration.

2. PURPOSE

7

3.1 OperatingPrinciples

Each model is uniquely designedand tested for use only with thedrug specified on the filler block.

The vaporizer contains a chamber,the base of which holds the anaes-thetic agent in liquid form. A wickensures that the upper part of thechamber is filled with the saturatedvapour of the agent. The wick hasa patented construction.

The concentration of saturatedvapour is many times higher thanthose used clinically and the func-tion of the concentration control isto proportion the flow of the carriergas through a bypass passage andthrough the vapour chamber sothat the desired dilution is pro-duced.In the zero position the bypassremains open but the vaporizingchamber is shut off completelyfrom the gas flow to the patient.

A temperature-compensating valveis situated in the bypass, arrangedto operate so that as the vapourpressure varies with temperature.the dilution ratio produced by thecontrol valve is varied to compen-sate. and maintain a constant out-put concentration.

The vaporizer has a liquid levelindicator, with maximum and mini-mum level marks.

1. Liquid level indicator2. Control dial 0 (zero) position3. Interlock bolt

3.2 ControlsThe vaporizer has a single, forwardfacing calibrated control to regulatethe vapour concentration delivered.The dial is locked at zero when notin use. To set a concentration level,push the dial assembly in androtate anti-clockwise.

Align the required concentrationgraduation with the mark at the topof the bezel.On returning the dial to zero, thedial assembly will automaticallyspring outwards into the locked 'off'position.

3. DESCRIPTION

23

1

8

Interlock ModelsWhen the vaporizer is mounted onthe anaesthetic machine back barwith other interlock vaporizers, ini-tial operation of the concentrationcontrol dial activates the interlocksystem ensuring that only one ofthe vaporizers con be in use at anytime.

The interlock deactivates as soonas the control dial is returned to thelocked out zero position.

NOTEThe Sigma Delta SelectatecCompatible Vaporizer withInterlock can be used on aSelectatec Universal SeriesManifold back bar in conjunctionwith other types of Selectatec com-patible vaporizers (i.e. from othermanufacturers) fitted with the inter-lock function.

WARNINGThe Drager compatible modelwith interlock must only be usedwith other Drager-compatibleinterlock vaporizers, to maintainthe integrity of the interlock sys-tem.

9

4.1 Physical Dimensions

Width Height Depth

Cagemount 133 219 158 Selectatec Compatible with Interlock 120 242 190Drager 'plug in' Compatible 100 242 190

Dimensions given above are in millimetresNOTEFor Screw Cap Filler models depth, subtract 11 mm from the depth dimen-sions given above.

4.2 Weight

Approximate weight: 4.8 kg.

4.3 Capacity

Volume at MAX mark 250 ml (nominal)Volume at MIN mark 35 ml (nominal)NOTEAfter draining, approximately 60 ± 10 mI of liquid is retained by the wick.

4.4 Filling System

Key Filler (Agent Specific)Used with corresponding agent specific filler adaptor, see section 10,Ordering Information.

Pour Fill (Screw Top)

Quik Fil - Sevoflurane onlyUse with corresponding agent specific bottle.

4. SPECIFICATION

10

4.5 Control Dial Scale

The control dial is marked as follows:From 0 to 2% vol, by intervals of 0.2% volFrom 2 to maximum, by intervals of 0.5% vol

The control dial is marked '0' at zero

4.6 Patents

The Sigma Delta is protected by UK and foreign patents.

4.7 Temperature Range

Operating Temperature Range 15 to 35oC (58 to 95oF)

Storage Temperature Range -20 to 50oC (-5 to 122oF)

Storage in Transit (up to 7 days) -40 to 60oC (-40 to 149oF)

4.8 Flow Range

Operating Flow Range 0.2 to 15 litres/min.

See section 7.4.1 for output accuracies at extreme conditions.

4.9 Pressure Range

Operating Pressure Range 0 to 5 kPa (0 to 0.7 psi)Maximum Manifold Pressure 38 kPa (5.5 psi)Maximum Test Pressure 38 kPa (5.5 psi)

SPECIFICATION

11

5.1 Key Filler System

WARNINGThe vaporizer must be eithersecured to the anaestheticmachine or free standing on alevel table so that in either caseit is upright during the fillingprocess.Overfilling may occur if thevaporizer is tipped during thefilling process.WARNINGThe vaporizer concentrationcontrol must be in the 0 (zero)position during the fillingprocess. Provided this is done,gas may continue to be deliv-ered from the anaestheticmachine to a patient during thefilling process.WARNINGCheck that the drug name on thevaporizer and the supply bottleare the same before commenc-ing the filling process, andensure that the bottle is fittedwith a keyed collar.

Filling the VaporizerThis system is manufactured incompliance with ISO 5360.

1. Check that the vaporizerconcentration control (1) isin the 0 (zero) position asillustrated.

2. Attach the keyed filler adap-tor (2) to the bottle (3).

NOTEPenlon supply a complete range ofagent specific filler adaptors, seesection 10.

3. Tighten the adaptor toensure an airtight joint,which must be maintainedthroughout the filling opera-tion.

WARNINGFailure to observe this instruc-tion may result in overfilling.

5. FILLING AND DRAINING

1

2

3

12

4. Loosen the clamp screw (4).Remove the plug (5).

5. Insert the keyed end of the bottleadaptor (2) fully into the vaporizerreceiver.Only the correct keyed-adaptor canenter the receiver.Tighten the clamp screw (4) tosecure the adaptor.

6. Raise the bottle above the filler(see arrow on the illustration).

7. Open the filler control (6) - liftupwards.Allow the liquid to flow into thevaporizer until the upper mark isreached on the filler block (7).

WARNING DO NOT OVERFILL.A vaporizer that has been overfilledmust be withdrawn from use.If the vaporizer has been inadvertentlyoverfilled, excess liquid agent will spillfrom the drain hole in the keyed slot in thefiller block. DO NOT REUSE THIS AGENTAllow all the excess liquid to drain from thevaporizer before inserting the plug (5).

8. Close the filler control (6).9. Lower the bottle below the level of

the filler and allow the liquid in thebottle adaptor to flow back into thebottle.Loosen the clamp screw (4),remove the bottle adaptor from thereceiver.

NOTEA small amount of liquid is always likely tospill when the bottle adaptor is removedfrom the receiver.

FILLING AND DRAINING

5

2

7

4

6

4

6

13

10. Insert the plug (5) and tightenthe clamp screw (4).

WARNINGFor the vaporizer to function cor-rectly it is important to insert thesealing plug (5) fully, until it stops,before clamping it into position withthe clamp screw (4) after filling iscompleted.If this is not done, the possibilityexists that agent may leak from thevaporizer or the vaporizer may notpressurise properly, giving reducedconcentration output and gas flowto the patient.


5

4

14

Draining the Vaporizer

CAUTIONTo reduce atmospheric pollution inthe operating room, it is recom-mended that vaporizer drainageshould be performed in a fumecupboard or under an extractorhood.

WARNINGThe vaporizer must be eithersecured to the anaestheticmachine or free standing on alevel table so that in either caseit is upright during the drainingprocess.WARNINGThe vaporizer concentrationcontrol must be in the 0 (zero)position during the drainingprocess

1. Check that the vaporizerconcentration control (1) isin the 0 (zero) position.

2. Follow steps 2 to 5 of theprocedure for filling thevaporizer (see above), butkeep the bottle below thefiller.

3. Raise the the filler control(2) and allow the liquid torun into the bottle until theflow ceases.

4. Close the filler control (2),loosen the clamp screw (3),and reinsert the plug (4).Tighten the clamp screw(3).


2

3

4

1

WARNINGAnaesthetic drugs must be treat-ed as a pharmaceutical product.Liquid should never be drainedfrom a vaporizer into an opencontainer and reused.Contamination is likely. Alwaysdispose of such drained liquidas a hazardous chemical.

15

5.2 Screw Cap FillingSystem (Pour Fill)

CAUTIONTo minimise atmospheric pollutionin the operating room, fill the vapor-izer in a fume cupboard or underan extractor hood.WARNINGThe vaporizer must be eithersecured to the anaestheticmachine or free standing on alevel table so that in either caseit is upright during the fillingprocess.Overfilling may occur if thevaporizer is tipped during thefilling process.WARNINGThe vaporizer control must be inthe 0 (zero) position during thefilling process.Provided this is done, gas maycontinue to be delivered fromthe anaesthetic machine duringthe filling process.WARNINGCheck the drug name on thevaporizer and the supply bottlebefore commencing the fillingprocess.

Filling the VaporizerIf the vaporizer is empty, checkthat the control screw (1) is fullytightened before filling1. Check that the vaporiz-

er concentration control (2)is in the 0 (zero) position asillustrated.

2. Unscrew the filler cap (3).

3. Remove the bottle cap andfill the vaporizer slowly andcarefully, stopping to checkthe liquid level occasionally.Stop filling when the uppermark is reached on the fillerblock.

WARNINGDO NOT OVERFILL. A vaporizer that has been over-filled must be withdrawn fromuse.

4. Replace the filler cap after avisual check that the seal isin position on the cap. Tighten finger tight only. DONOT use a wrench.

WARNINGDo not operate the vaporizer ifthe filler cap is not secured inposition.Incorrect concentration may bedelivered to the patient and pol-lution may result.


2

1

3

16

Draining the Vaporizer

CAUTIONTo minimise atmospheric pollutionin the operating room, performvaporizer drainage in a fume cup-board or under an extractor hood.

WARNINGThe vaporizer must be eithersecured to the anaestheticmachine or free standing on alevel table, so that in either caseit is upright during the drainingprocess.

WARNINGThe vaporizer concentrationcontrol must be in the 0 (zero) position during the drainingprocess.

1. Check that the vaporiz-er concentration control (1)is in the 0 (zero) position, asillustrated.

2. Unscrew the filler cap (2).

3. Place a bottle marked withthe drug name on thevaporizer under the draintube in the base of the fillerblock and undo the drainscrew (3) at least three fullturns.

WARNINGAnaesthetic drugs must be treat-ed as a pharmaceutical product. Liquid should never be drainedfrom a vaporizer into an open

container and reused. Contamination is likely. Alwaysdispose of such drained liquidas a hazardous chemical.

4. Allow the liquid to run intothe bottle until the flowceasesClose the drain screw (3).

CAUTIONAlways close the drain screw firmlybefore replacing the filler cap onthe vaporizer.


3

1

2

17

5.3 Quik-Fil System

WARNINGS

1. Do not use the anaestheticagent bottle to fill thevaporizer if the bottle iscracked or the filler con-nector is loose or broken. This may result in overfill-ing or contaminated agententering the vaporizer.

2. If a new bottle of anaesthet-ic agent is to be used,check that the tamper-evi-dent shrink band is undam-aged.

3. Firmly secure the vaporizerin a vertical position beforefilling.

4. Ensure that the drain plugscrew, located on the lowerfront of the vaporizer, iscorrectly tightened to pre-vent loss of liquid agent.

5. Do not tamper with the fill-ing system valve. This maycause a vapour and freshgas leak.

6. The filler system must bemaintained in accordancewith the instructions given


in the User Maintenancesection.

7. The vaporizer must befilled only by suitablyskilled and trained person-nel.

8. After filling, remove thebottle and refit the fillerblock cap before using thevaporizer.

9. Do not use the vaporizer ifthe agent level is not visi-ble in the sight glass or thelevel is outside of theMax - Min indicators.

18


Quik-Fil System - Fillingthe Vaporizer

1. Check that the vaporizerconcentration control is in theoff ('0') position.

2. Remove the yellow protectivecap from the anaesthetic agentbottle filler, checking that thebottle and filler mechanism arenot damaged.

3. Remove the vaporizer fillerblock cap and insert the bottlenozzle into the filler block,Rotate the bottle to align thebottle filler keys with the slots inthe filler block.

4. Note the liquid level in thevaporizer sight glass and pressthe agent bottle firmly into thevaporizer filler against thespring valve assembly. Allow the liquid to flow into thevaporizer until the maximumlevel mark is reached, payingcontinuous attention to the levelin the sight glass and the airreturn bubbles flowing into thebottle.

5. Release the bottle when thevaporizer is full and thecontinuous stream of bubblesceases.

6. Withdraw the bottle from thevaporizer filler and replace thevaporizer filler block cap andthe yellow cap on the agentbottle.

WARNINGThe filler cap must be refittedbefore using the vaporizer.

19

Quik-Fil System - Drainingthe vaporizer

WARNINGTo avoid spillage, check that thebottle to be used for draining hassufficient capacity for the volume of liquid to be drained.

1. Remove the yellow protectivecap from an empty sevofluranebottle. Insert the bottle nozzleinto the drain funnel. Rotate the bottle to align thebottle filler keys with the indexslots in the drain funnel, andscrew the drain funnel onto theempty bottle.

2. Remove the vaporizer fillerblock cap.

3. Fully insert the drain funnel intothe keyed drain slot, andunscrew the drain plug.Continue to drain the vaporizeruntil empty. Close the drain plug and tight-en, and withdraw the drain fun-nel.

4. Unscrew the drain funnel fromthe bottle and refit the bottlecap and the vaporizer fillerblock cap.

WARNINGThe filler cap must be refitted beforeusing the vaporizer.

WARNINGDo not reuse the agent drained fromthe vaporizer. Treat as a hazardouschemical.


20

6.1 Gas Port TransitSeals

All vaporizersCAUTION Inlet and outlet ports are sealed fordelivery transit. Ensure that theseseals are removed from thevaporizer before installation on ananaesthetic machine.

6.2 SelectatecCompatible Models- with Interlock

These vaporizers are designed forinstallation on a SelectatecUniversal Series type manifoldback bar and can also be used onthe Type 3 Manifold.

NOTEWhen installing two vaporizers onlyon a three station manifold, thecentre station must be occupied byone of the vaporizers.

WARNINGAnaesthetic machine designsare constantly evolving, and newmodels may differ dimensionallyfrom existing equipment

It is the user's responsibility toensure that the configuration of theanaesthetic machine allows correctinstallation of the vaporizer.There must be sufficient clearancebetween the Selectatec manifold

and the rear panelling/frame of themachine to allow the vaporizerconnector block to seal correctly onthe manifold.

6. INSTALLATION

1. Locking Lever2. Interlock Bolts3. Back Bar Manifold Locking Shaft

1

2

2

3

21

Installation1. Carefully offer the vaporizer

up to the manifold.2. Align the gas connection

ports with the valve capsuleon the manifold. (The cap-sule is referred to as thevalve ‘cartridge' in someuser literature)

3. Carefully lower the vaporiz-er onto the manifold, andrecheck that the gas portsare correctly engaged withthe valve capsule cartridgeson the manifold.

4. Lock into position by push-ing the locking lever down-wards and rotating clock-

wise through 90o.CAUTIONTo prevent damage to the lockingshaft, recheck that the gas portsare correctly engaged with thevalve capsule cartridges on thevaporizer before tightening thelocking lever.

Pre-use ChecksObserve the WARNING below andcarry out the check list proceduregiven in section 6.7.

WARNINGTest all joints for gas tightnessbefore using the anaestheticmachine.

The locking lever MUST be in thelocked position before the vaporiz-er is operated.

INSTALLATION

Removal

NOTEThe concentration control dials ofall the vaporizers linked by theinterlock system must be turned tozero before removing the vaporizerfrom the manifold.

To remove the vaporizer, rotate the

locking lever 90o anti-clockwiseand carefully lift the unit verticallyuntil clear of the back bar.

22

6.3 Cagemount (23 mm)Taper Models

CAUTIONIt is recommended that this type ofvaporizer should only be used onmachines with a single vaporizermounting station.

Vaporizers fitted with cagemounttapers have the male taper (1) (Inletport) on the left and the female taper(2) on the right (viewing the front ofthe vaporizer). Two M6 studs with nuts, washersand a clamp plate (3) are providedto fix the vaporizer to the back of theanaesthetic machine, or Moduraclaw assembly.

Taper ConnectorsIt is essential that the taper conejoints should be engaged axially andnot sideways loaded. 1. Adjust the distance from the

back bar to the taper joint byadding or removing theshims (4) .

2. The cone joints should belightly smeared with an oxy-gen compatible lubricantsuch as Fomblin.

3. Engage the taper joints byapplying axial pressure.

4. Tighten the fixing nuts (3).

INSTALLATION

1

2

3

4

23

4. Attach the vaporizer to theModura rail on theanaesthetic machine andsecure in place by movingthe lever into its 'locked on'position.

Pre-use CheckObserve the WARNING below andcarry out the check list proceduregiven in section 6.7.WARNINGTest the joints for gas tightnessbefore using the machine.

6.4 Penlon Off-lineMounting System

A vaporizer with cagemount tapersmay be fitted with a Penlon clip,Part No. 58090, in place of theback bar clamp. The vaporizer maythen be fitted to a Penlon off-lineblock, (use Penlon Part No. 52280for the Mk.2 and Part No, 52270 forthe Mk.3 system).The flexible hoses attached to theblock are connected to the inletand outlet of the vaporizer.

It is recommended that detachablecagemount connectors areretained with Safety Clip (PartNumber 52275), to preventinadvertent disconnection,WARNINGTest the joints for gas tightnessbefore using the machine.

INSTALLATION

1

2

3

Installation on Modura RailWARNINGThe vaporizer must not be tippedor inverted during installation.If the vaporizer has been tippedor inverted, it must be set tomaximum and flushed at 5 L/minfor ten minutes. Check for stableoutput before clinical use.

1. Remove the M6 nuts andwashers, the clamp plate andthe shims from the vaporizer.

2. Fit the Modura claw (1) to thebackplate (2), using the twoM6 screws.

3. Fit the Modura clawbackplate assembly to thestuds (3) on the rear of thevaporizer, and secure withthe M6 nuts and washers.

24

6.5 Drager 'Plug-in'Compatible (interlock)

InstallationNOTEWhen installing two vaporizers onlyon a three station manifold, thecentre station must be occupied byone of the vaporizers.1. Carefully offer the vaporizer

up to the manifold.2. Align the gas connection

ports with the valve capsuleon the manifold. (Thecapsule is referred to as thevalve ‘cartridge' in someuser literature)

3. Carefully lower thevaporizer onto the manifold,and recheck that the gasports are correctly engagedwith the valve capsulecartridges on the manifold.

4. Lock into position bypushing the locking lever (1)downwards and rotatingclockwise through

approximately 100o.

Pre-use ChecksObserve the WARNINGS belowand carry out the check listprocedure given in section 6.7.WARNINGTo prevent damage to thelocking shaft (3), and to ensurethat the gas connection portsare correctly engaged, check

INSTALLATION

that the vaporizer is firmlypositioned on the manifold beforetightening the locking lever.The locking lever MUST be in thelocked position before thevaporizer is used.

Removing the VaporizerRotate the locking lever fullyanticlockwise and carefully lift thevaporizer from the manifold.

1

2

3

1. Locking Lever2. Interlock Bolts3. Back Bar Manifold Locking Shaft

25

6.6 North AmericanDrager Compatible(Interlock)

Installation1. Check that each gas port (1) is

fitted with the correct O seal,as supplied by the anaestheticmachine manufacturer (Dragerpart No. M21929).

2. Carefully offer the vaporizer upto the manifold.

3. To secure the vaporizer to themanifold, use two M4 x 30screws (DIN 912 PropertyClass 8.8) and fan-type lockwashers, as supplied with themachine.From the rear of theanaesthetic machine fit thetwo screws through themanifold block holes (2), andscrew into the threaded holesin the vaporizer.Tighten the screws to a torqueof 2.7 to 3.0 Nm.

Pre-use ChecksCarry out the check list proceduregiven in section 6.7.

Removing the Vaporizer1. Support the vaporizer, and

remove the securing screws.2. Detach the vaporizer from the

manifold.3. Check that the O-seals are

retained in the gas ports (1).

INSTALLATION

2

2

1

1

26

6.7 Pre-Use Check List

In addition to the pre-use warningslisted for different models in sec-tions 6.2 to 6.6 the following checklist procedure must be carried outon ALL vaporizers before use.

1. Check that the vaporizerconcentration control is inthe 0 (zero) position.

2. Check that the liquid level isbetween the upper andlower marks on the fillerblock.

3. On key fill (agent specificfiller) models, check that thefiller plug is fully insertedand that the clamp screw isfully tightened.

4. On pour fill (screw cap filler)models, check that the fillercap is securely closed.

5. Perform a back bar mani-fold leak test as detailed inthe relevant anaestheticmachine user instructionmanual.

WARNINGAnaesthetic machine designsare constantly evolving and newmodels may differ dimensionallyfrom existing equipment.

It is the user's responsibility toensure that the configuration of theanaesthetic machine allows correctinstallation of the vaporizer.

INSTALLATION

27

NOTEConcentration output figures quoted andshown graphically in this section were compiledfrom average test results from a number ofvaporizers. The output from individual units may vary fromthese average figures.

7. PERFORMANCE CHARACTERISTICS

28

7.1 Performance Graphs7.1.1 Halothane

PERFORMANCE CHARACTERISTICS

6

5

4

3

2

1

0

6

5

4

3

2

1

0

0.2 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 Flow rate L/min

10 15 20 25 30 35 Temperature oC

5% set

4% set

2% set

1% set0.6% set0.2% set

5% set

4% set

2% set


Variation of output with flow rate (Temperature: 20oC)

Variation of output with temperature (Flow rate: 5 L/min)

Out

put

Vol

%O

utpu

t V

ol%

29

7.1.2 Enflurane Models


6

5

4

3

2

1

0

0.2 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 Flow rate L/min

5% set

4% set

2% set



Out

put

Vol

%

6

5

4

3

2

1

0

10 15 20 25 30 35 Temperature oC

5% set

4% set

2% set


Out

put

Vol

%

30



7.1.3 Isoflurane Models

6

5

4

3

2

1

0

0.2 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 Flow rate L/min

5% set

4% set

2% set



Out

put

Vol

%

6

5

4

3

2

1

010 15 20 25 30 35

Temperature oC

5% set

4% set

2% set


Out

put

Vol

%

31



7.1.4 Sevoflurane Models

9

8

7

6

5

4

3

2

1

00.2 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15

Flow rate L/min

8% set7% set6% set

5% set

4% set

3% set

2% set


8% set

6% set

5% set

4% set

2% set



Out

put

Vol

%

8

7

6

5

4

3

2

1

010 15 20 25 30 35

Temperature oC

Out

put

Vol

%

32


7.2 TemperatureCompensation

Temperature compensation is pro-vided by the operation of a variableresistance valve in the bypass pas-sage. The design provides com-pensation for the full range of usertemperatures. If the vaporizer isused in extreme temperatures,(outside those shown in section4.7) outputs may be lower or high-er than indicated by the concentra-tion control.NOTEThe temperature compensatorreacts relatively slowly to roomtemperature changes. If the temperature around thevaporizer is suddenly changed(e.g. by wheeling an anaestheticmachine from a cool store into the-atre), 1 to 2 hours minimum shouldbe allowed for it to equalise withthe ambient temperature beforeuse.

7.3 Pressure Effects7.3.1 Ambient PressureAmbient pressure effects are notnormally of clinical significance butthe following rules apply:The control is graduated in units ofvol% at 101.3 kPa (14.7 psi). Atany other pressure the true outputwill be modified according to theequation:

C = S% x 101.3P

P is absolute pressure in kPa.

C is delivered concentration vol%,S% is the set value.

Changes in barometric pressurecan be ignored clinically becausethey affect the vaporization in thevaporizer and the absorption ofvapour through the lungs in thesome way. They must be correctedfor when checking outputs with ananalyser.NOTESome analysers include automaticbarometric pressure correction.Check the instructions providedwith the analyser.

7.3.2 Back PressureBack pressures imposed on thevaporizer by ventilators or otherparts of the anaesthetic apparatusare usually relatively small, but cer-tain ventilators can impose steadyback pressures of 10 to 15 kPa(100 to 150 cmH2O) which will pro-duce a reduction of the output con-centration.

7.3.3 Intermittent BackPressure

Intermittent back pressure imposedon the vaporizer by a ventilatormay result in some change in out-put. The effect is greatest at lowsettings of the control and low flowrates, and the Sigma Delta vaporiz-er is designed to comply with thetests laid down in variousStandards in this respect (see sec-tion 9).


33

A (Normal Use) B (Extreme Conditions)

Gas composition O2, Air + N2O mixture Helium mixture, section 7.6

Liquid level Liquid visible between See section 1, WARNING 18MIN and MAX marks

Temperature 15 to 35oC 10 to 15oC and 35 to 40oC, section 7.2

Flow Rate 0.5 to 10 L/min 0.2 to 0.5 and 10 to 15 L/min Accuracy not affected.

Altitude Sea level to 2440 m Very high altitudes* (8000 ft) or hyperbaric conditions*

Intermittent back As Standards listed in pressure section 9 (a)Movement Do not agitate during use See section 1, WARNING 21

Inversion or tipping Do not tip or invert Flush for 10 minutes at5 L/min before use.See section 1, WARNING 20

*The combination of high altitude and high temperature may lead to loss of accuracy.

7.4 Summary of PerformanceSpecifications

7.4.1 Factors Affecting OutputAccuracy

The following conditions may affect the accu-racy of the vaporizer. Column A in the table shown below lists thedesign limits for normal use. Column B lists extreme conditions, and, if nec-essary, indicates when the vaporizer may beused reliably only after reference to the sec-tions of the manual indicated.

Under the conditions listed in column A, themaximum deviation from the set concentrationis ±20% of scale reading or ±5% of the maxi-mum graduation, whichever is greater.


34

7.4.2. Resistance to GasFlow

Resistance to gas flow, measuredat:

22oC (72oF) 101.3 kPa (1013 mbar, or 14.7 psi), Control position 0 (zero)

Flow Rate Resistanceusing Air (cmH2O)(L/min)

1 1.82 3.44 8.08 20.3

Resistance varies from these nom-inal values at other control posi-tions, with changes with tempera-ture, and for each agent (e.g. thenominal value for Sevoflurane at 4L/min (air) is 12 cmH2O).

7.5 Effect of IPPV onOutput

For 2 kPa IPPV at a flow rate of 2L/min, output concentration willvary by up to 20%,For 5 kPa IPPV at a flow rate of 8L/min, output concentration willvary by up to 10%.

7.6 Effect of GasComposition onOutput

The vaporizer is calibrated withpure oxygen and the scale is there-fore most accurate with this gas.The effect of other gases normallyused in anaesthesia is as follows:

Nitrous oxideNitrous oxide, added to oxygen, willproduce a decrease in outputbelow the scale value. At a con-centration of 70% nitrous oxide out-put may decrease by up to 15%.

Carbon dioxideCarbon dioxide is not usuallyadded in high concentrations and isusually limited to 5%. At this con-centration the effect on vaporizeroutput is negligible.

AirAir will reduce the output of thevaporizer below the scale valuesby a maximum of 5%.

HeliumVaporizers will give low results onhelium-enriched mixtures, and theuse of an analyser is recommend-ed if accurate concentrations arerequired when using this gas.


35

7.7 Output whenControl is at 0(zero)

Output vapour concentration whenthe control is at 0 (zero) is less than0.03% vol., when tested in accor-dance with ASTM 1161-88.

7.8 Effect of FlushValve Operation

Operating the flush valve on theanaesthetic machine will affect out-put concentration by less than±20%.Note that the vaporizer was testedto ISO 8835.1 / IEC 60601-2-13.


36

CAUTIONDo not attempt to dismantle thevaporizer or make any adjustmentto it which is outside the scope ofthe following instructions.

8.1 Servicing

NOTEA label is fixed across the vaporiz-er body and top cover, bearing thewords:

GENUINE PART.LABEL TAMPERINGVOIDS WARRANTY.

When the bottom cover of thevaporizer is removed this label willbe damaged beyond repair as per-manent evidence of unauthorisedservicing, repair or modification.If this label (or other labels) is miss-ing, do not use the vaporizer until ithas been serviced (see below).

The Sigma Delta must only beserviced at an authorised servicecentre or by Penlon-trained techni-cians in accordance with the fol-lowing procedure.

(a) The calibration should bechecked periodically undercontrolled conditions (section8.4) and leak tests per-formed. Record the measured valuesin section 11.

(b) Successive sets of figuresshould be compared to deter-mine if performance is deteri-orating. Should deterio-ration be detected, a serviceshould be carried out torestore normal operation.

(c) A major overhaul must beperformed every ten years(Halothane models - 5 years)to maintain performancewithin the specification.

(d) The Selectatec compatiblevaporizer locking systemshould be inspected duringthe vaporizer calibration test,and if damage to the lockingshaft is suspected, the devicemust be referred to a Penloncertified engineer,

(e) Interlock system vaporizers -function test the interlock sys-tem during the vaporizer cali-bration test.

(d) Quik-Fil system - at regularintervals (3 monthly mini-mum, 6 monthly maximum),filling and draining must bechecked under controlledconditions

NOTEThe user must accept responsibili-ty for any malfunction which resultsfrom non-compliance with theabove requirements.

8. USER MAINTENANCE

37

8.2 Cleaning andSterilisation

WARNINGDo not pour water, or anycleaning solutions into thevaporizer.The process of filling and emptyingwill clean the internal passagewaysof the vaporizer filler blocksatisfactorily.The exterior of the vaporizer shouldbe kept clean and dust free with adry cloth, or, if necessary useproprietary cold sterilised wipes.Do not use water or other liquids.

8.3 Draining -Halothane Models

Because halothane contains astabilising agent which is onlyslightlyvolatile (0.1% thymol), thevaporizer chamber should bedrainedperiodically of all liquid and theliquid disposed of as a hazardouschemical. If the vaporizer is notdrained periodically, the stabilisingagent will accumulate in thevaporizer and eventually cause lowoutput.

There is some evidence that highlevels of accumulated thymol canhave clinically undesirable effectson the patient. (Ref. Rosenburg -Alila: Anaesthesia, 1984:38:581-583).

If the vaporizer is in regular use thisdraining operation should beperformed weekly.WARNINGProlonged exposure ofanaesthetic agents to light andgases may lead to a brown oryellow colouration.

Discoloured liquid and/or liquiddrained from a vaporizer must notbe used and should be disposed ofas a hazardous chemical.

8.4 CheckingVaporizer Output

The output of the vaporizer shouldbe checked periodically, either:

(i) as part of the PenlonService Contract (UK only)

(ii) by a Penlon certifiedengineer

(ill) by a suitably qualifiedhospital technician if agentanalysis apparatus isavailable.

To be comparable with the mastercalibration, such tests mustconform to the following.

(a) The carrier gas should beoxygen.

(b) The vaporizer must befilled, and fixed upright andstationary, at a temperature

between 18 and 22oC (64

and 72oF) for at least 2hours.

USER MAINTENANCE

38

(c) A mixing chamber must beattached to the outlet of thevaporizer to ensure that ahomogenous mixture issampled.This is particularlynecessary at low gas flowrates.

(d) The sampling system mustbe of non-absorbentmaterial such as nylon.(Rubber, etc., absorbsvapour to a substantialextent.)

(e) Flow rates, etc., must liewithin the range covered bythe master calibrationcharts.

(f) The analysis apparatusmust be of an approvedtype, e.g. a Rikenrefractometer.However, if the calibrationcheck is undertaken by ahospital technician, it ispermissible to use acommercially availableagent analyser, but only if:i) the analyser is calibratedto the manufacturer’sspecification and scheduleii) output failures areconfirmed by a Penloncertified engineer using arefractometer,

g) Output values should berecorded in section 11.The vaporizer serial numberand any comments must bewritten at the foot of eachpage.

8.5 Training CoursesA training course is available toengineers and hospital staff whowish to carry out routinemaintenance on vaporizers. The course covers:- leak testing- replacement of seals- internal maintenance- replacement of major

subassemblies- regulation of output

A manual describing this work isavailable to personnel who haveundergone this course.

8.6 Returning theVaporizer for Serviceor Repair

The vaporizer must be drained andallowed to dry out before packing.Always use the original packaging,to prevent damage during transit.

On key fill (agent specific filler)vaporizers, loosen the clamp screwand withdraw the plug (see section5.1). This will prevent possibledamage to the filler block seal.

USER MAINTENANCE

39

Standards

The Sigma Delta vaporizer has been designed in accordance withthe following Standards.

(a) GeneralBS 4272, Part 3 1989, Sections 13, 14ISO 5358, 1992, Sections 12/13/14IEC 60601 - 2.13ASTM F1 161, 1988, Section 12CSA CAN3 Z168.3 M84, Section 12DIN 13252, Sections 4,9 - 4.13, and 5,9 - 5.13

(b) Agent Specific (Keyed) Filling SystemCSA CAN3Z 168.4 M83DIN 13252, Sections 4.11 and 5.11ISO 5360, 1993

Trademarks

Selectatec is a Datex Ohmeda trademark.

Modura is an S&W trademark.

9. REFERENCES

40

A wide range of Halothane, Enflurane lsoflurane and Sevoflurane vaporizersare available Various combinations of agent, concentration output, and connector blocktype. are available with either agent specific filler, screw cap, and Quik-Filfiller systems

For further information:Contact your distributor, or Customer Service at Penlon Ltd.

UK:Tel: 01235 547036Fax: 01235 547023E-mail: [email protected]

InternationalExport: Tel: +44 1235 547001 Fax: + 44 1235 547021 E-mail: [email protected]

Accessories

52275 Safety clip for cagemount tapers (Off-line system only)

53450 Agent Specific (Keyed) filler adaptor for halothane bottles(ICI, May and Baker, and Hoechst)

53451 Agent Specific (Keyed) filler adaptor for halothane bottles(Ohio, and Ayers)

53452 Agent Specific (Keyed) filler adaptor for enflurane bottles53453 Agent Specific (Keyed) filler adaptor for isoflurane bottles53454 Agent Specific (Keyed) filler adaptor for sevoflurane bottles

10 ORDERING INFORMATION

41

11.1 Service Policy

The Sigma Delta Vaporizer must be serviced according to the followingsystem:

a) The calibration should be checked periodically under controlledconditions and leak tests performed.For further information, Penlon-trained engineers should refer to therelevant section in the the service manual.The measured figures should be recorded in section 11.4 of thisbook.

At the completion of each Ten Year Overhaul (five year overhaul forHalothane models), a copy of the completed calibration records insection 11.4 must be faxed to Penlon Limited (Fax No: 44 1235547062).

b) By comparing several sets of successive figures, a trend inperformance can be established and a service performed before thestandard tolerance is exceeded.

c) If the calibration check shows a departure from the standardperformance or a trend towards predicted failure, the vaporizer mustbe serviced as described in the service manual.

d) All vaporizers must be overhauled every ten years (Halothanemodels every five years) and certain items replaced even if theperformance appears satisfactory.

This is a preventive maintenance requirement.

e) Record repair and servicing work carried out on the vaporizer, insection 11.3 of this book.

11. SERVICE RECORDS

42

11.2 Calibration Procedure using the Riken Analyser

The Riken Model 1F-18 is normally calibrated by the manufacturer formeasuring up to 8% vol. Halothane, or up to 9% Sevoflurane, either inair or in oxygen.Service checks on the vaporizer must be performed with oxygen if thevaporizer is checked on an anaesthetic machine.Use air or oxygen if the vaporizer is checked in a test laboratory.

CAUTIONA) It is essential that the gas used during service checks is recorded,B) The reference cell of the Riken must be purged with the appropriategas before measurements are made.

AgentsThe Riken gas analyser measures the refractive index of the gases andvapours and, although normally calibrated for measuring halothane, theinstrument can also measure other vapours if an appropriate correctionfactor is applied.To obtain the true concentration of gases other than halothane multiplythe reading shown on the Riken analyser by the correction factors givenbelow.

Carrier GasThe refractive index of oxygen is higher than that of air so that,(a) the unit must be re-zeroed if the carrier gas is changed, and (b) the scale must be adjusted by a correction factor, applied bymultiplying the Riken scale reading to obtain the true concentration.

Correction Factors:

Halothane in Air RikenFactor (using air) Factor (using oxygen)

Halothane 1 1.06Enflurane 1.05 1.11Isoflurane 1.06 1.12Sevoflurane 1.05 1.10

SERVICE RECORDS

43

Halothane in Oxygen RikenFactor (using air) Factor (using oxygen)

Halothane 0.95 1Enflurane 0.99 1.05Isoflurane 1 1.06Sevoflurane 0.99 1.05

Temperature and Barometric PressureCalibration checks must be performed at a temperature between 19 and

21oC. The correction factor is ± 1.5% of readings, which is negligible in view ofthe accuracy of the instrument. Temperature correction is therefore not required, but the temperatureshould be measured and recorded to ensure that the test is carried outwithin the specified range.

Changes of barometric pressure due to weather are not normally ofsignificance and can be ignored.

Altitude can, however, have significant effects and the following correctionfactors should be applied when appropriate.The Riken reading multiplied by the stated correction factor gives the trueconcentration corrected to Standard Temperature and Pressure (STP).

Altitude Factor Barometric Pressure(for reference)

600 m (2000 ft) 0.9 910 mb1200 m (4000 ft) 0.85 850 mb1800 m (6000 ft) 0.8 813 mb

Method of reading the Riken Analyser1. Readings may be taken from a tee-piece connected to the common

gas outlet of the anaesthetic machine. An AGS system must be connected.

2. The sampling tube must be nylon or PTFE (which do not absorbvapours).

SERVICE RECORDS

44

Rubber sleeves may be used to make end connections but theremust be minimal length of rubber exposed to the gases beingsampled.

3. Sample by 2 or 3 squeezes of the hand bulb. Wait for fringemovement to cease before taking the reading.

4. After each resetting of the vapour control, time must be allowed forthe output to stabilise. Suggested timescale: at 2 L/min flow - wait 4 minutes

4 L/min flow - wait 2 minutes 8 L/min flow - wait 1 minute

5. As stated in the Service Manual: a) The vaporizer must be half full, and rigidly supported in itscorrect operating position b) Temperatures must be stabilised for approximately 4 hoursbefore checking

c) The temperature must be in the range 19 to 21oC.

SERVICE RECORDS

45

11.3 Servicing and Repair Details

Give details of any servicing, component replacements, etc., carried out onthe vaporizer.

Date Comments (including any additional work) Signature

SERVICE RECORDS

46


SERVICE RECORDS

47


SERVICE RECORDS

48


SERVICE RECORDS

49

SERVICE RECORDS

50

Year One

Test Period 1 2 3 4

Vaporizer serial number:

Date:

Signature:

Print name:

Carrier GasLeak Test (at 200 mmHg for minimum 60 secs)Pressure must not drop below 180 mm Hg

Set Tolerance

0.0 0 - 0.1

0.2 0.14 - 0.26

0.6 0.45 - 0.75

1.0 0.8 - 1.2

3.0 2.4 - 3.6

*4.0 3.2 - 4.8

5.0 4.0 - 6.0

**7.0 5.6 - 8.4

**8.0 6.4 - 9.6

**7.0 5.6 - 8.4

5.0 4.0 - 6.0

3.0 2.4 - 3.6

1.0 0.8 - 1.2

0.6 0.45 - 0.75

0.2 0.14 - 0.26

0.0 0 - 0.1* 4% Halothane vaporizer only

** 7% and 8% vaporizers only

Bypass resistance at 4 L/min

Comments:

SERVICE RECORDS

51

Year Two

Test Period 1 2 3 4


Date:

Signature:

Print name:


Set Tolerance

0.0 0 - 0.1

0.2 0.14 - 0.26

0.6 0.45 - 0.75

1.0 0.8 - 1.2

3.0 2.4 - 3.6

*4.0 3.2 - 4.8

5.0 4.0 - 6.0

**7.0 5.6 - 8.4

**8.0 6.4 - 9.6

**7.0 5.6 - 8.4

5.0 4.0 - 6.0

3.0 2.4 - 3.6

1.0 0.8 - 1.2

0.6 0.45 - 0.75

0.2 0.14 - 0.26




Comments:

SERVICE RECORDS

52

Year Three

Test Period 1 2 3 4


Date:

Signature:

Print name:


Set Tolerance

0.0 0 - 0.1

0.2 0.14 - 0.26

0.6 0.45 - 0.75

1.0 0.8 - 1.2

3.0 2.4 - 3.6

*4.0 3.2 - 4.8

5.0 4.0 - 6.0

**7.0 5.6 - 8.4

**8.0 6.4 - 9.6

**7.0 5.6 - 8.4

5.0 4.0 - 6.0

3.0 2.4 - 3.6

1.0 0.8 - 1.2

0.6 0.45 - 0.75

0.2 0.14 - 0.26




Comments:

SERVICE RECORDS

53

Year Four

Test Period 1 2 3 4


Date:

Signature:

Print name:


Set Tolerance

0.0 0 - 0.1

0.2 0.14 - 0.26

0.6 0.45 - 0.75

1.0 0.8 - 1.2

3.0 2.4 - 3.6

*4.0 3.2 - 4.8

5.0 4.0 - 6.0

**7.0 5.6 - 8.4

**8.0 6.4 - 9.6

**7.0 5.6 - 8.4

5.0 4.0 - 6.0

3.0 2.4 - 3.6

1.0 0.8 - 1.2

0.6 0.45 - 0.75

0.2 0.14 - 0.26




Comments:

SERVICE RECORDS

54

Year Five

Test Period 1 2 3 4


Date:

Signature:

Print name:


Set Tolerance

0.0 0 - 0.1

0.2 0.14 - 0.26

0.6 0.45 - 0.75

1.0 0.8 - 1.2

3.0 2.4 - 3.6

*4.0 3.2 - 4.8

5.0 4.0 - 6.0

**7.0 5.6 - 8.4

**8.0 6.4 - 9.6

**7.0 5.6 - 8.4

5.0 4.0 - 6.0

3.0 2.4 - 3.6

1.0 0.8 - 1.2

0.6 0.45 - 0.75

0.2 0.14 - 0.26




Comments:

SERVICE RECORDS

55

Year Six

Test Period 1 2 3 4


Date:

Signature:

Print name:


Set Tolerance

0.0 0 - 0.1

0.2 0.14 - 0.26

0.6 0.45 - 0.75

1.0 0.8 - 1.2

3.0 2.4 - 3.6

*4.0 3.2 - 4.8

5.0 4.0 - 6.0

**7.0 5.6 - 8.4

**8.0 6.4 - 9.6

**7.0 5.6 - 8.4

5.0 4.0 - 6.0

3.0 2.4 - 3.6

1.0 0.8 - 1.2

0.6 0.45 - 0.75

0.2 0.14 - 0.26




Comments:

SERVICE RECORDS

56

Year Seven

Test Period 1 2 3 4


Date:

Signature:

Print name:


Set Tolerance

0.0 0 - 0.1

0.2 0.14 - 0.26

0.6 0.45 - 0.75

1.0 0.8 - 1.2

3.0 2.4 - 3.6

*4.0 3.2 - 4.8

5.0 4.0 - 6.0

**7.0 5.6 - 8.4

**8.0 6.4 - 9.6

**7.0 5.6 - 8.4

5.0 4.0 - 6.0

3.0 2.4 - 3.6

1.0 0.8 - 1.2

0.6 0.45 - 0.75

0.2 0.14 - 0.26




Comments:

SERVICE RECORDS

57

Year Eight

Test Period 1 2 3 4


Date:

Signature:

Print name:


Set Tolerance

0.0 0 - 0.1

0.2 0.14 - 0.26

0.6 0.45 - 0.75

1.0 0.8 - 1.2

3.0 2.4 - 3.6

*4.0 3.2 - 4.8

5.0 4.0 - 6.0

**7.0 5.6 - 8.4

**8.0 6.4 - 9.6

**7.0 5.6 - 8.4

5.0 4.0 - 6.0

3.0 2.4 - 3.6

1.0 0.8 - 1.2

0.6 0.45 - 0.75

0.2 0.14 - 0.26




Comments:

SERVICE RECORDS

58

Year Nine

Test Period 1 2 3 4


Date:

Signature:

Print name:


Set Tolerance

0.0 0 - 0.1

0.2 0.14 - 0.26

0.6 0.45 - 0.75

1.0 0.8 - 1.2

3.0 2.4 - 3.6

*4.0 3.2 - 4.8

5.0 4.0 - 6.0

**7.0 5.6 - 8.4

**8.0 6.4 - 9.6

**7.0 5.6 - 8.4

5.0 4.0 - 6.0

3.0 2.4 - 3.6

1.0 0.8 - 1.2

0.6 0.45 - 0.75

0.2 0.14 - 0.26




Comments:

SERVICE RECORDS

59

Year Ten

Test Period 1 2 3 4


Date:

Signature:

Print name:


Set Tolerance

0.0 0 - 0.1

0.2 0.14 - 0.26

0.6 0.45 - 0.75

1.0 0.8 - 1.2

3.0 2.4 - 3.6

*4.0 3.2 - 4.8

5.0 4.0 - 6.0

**7.0 5.6 - 8.4

**8.0 6.4 - 9.6

**7.0 5.6 - 8.4

5.0 4.0 - 6.0

3.0 2.4 - 3.6

1.0 0.8 - 1.2

0.6 0.45 - 0.75

0.2 0.14 - 0.26




Comments:

Cat No 52606 Doc No D0102UIFebruary 2002

Penlon LimitedRadley RoadAbingdonOX14 3PHUK

Service Tel: +44 (0) 1235 547063Fax: +44 (0) 1235 547062E-mail: [email protected]

International SalesTel: +44 1235 547001Fax: +44 1235 547021E-mail: [email protected]

UK SalesTel: 01235 547036Fax: 01235 547023E-mail: [email protected]

Delta User Comp - Frank's Hospital Workshopfrankshospitalworkshop.com/equipment/documents...Sigma...

Documents

Transcript of Delta User Comp - Frank's Hospital Workshopfrankshospitalworkshop.com/equipment/documents...Sigma...