Vaporiser Instructions - Duggan Veterinary Supplies Ltd
Contents
1. 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 Blease Datum User Manual 17 2 Vaporizer Description Principles of Operation Figure 3 Key A Inlet Connector B Outlet Connector C Concentration Control K Anesthetic Drug in Liquid Form t Vapor Chamber ev Wick IPPV Coil Fenno Rp mer Figure 3 Vaporizer Components 18 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 concentra tion 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 d2. 9 Part Numbers Description Part Number Isoflurane 5 Keyed filler Cagemount 13011118 Isoflurane 5 Keyed filler Selectatec Interlock compatible 13012118 Isoflurane 5 Keyed filler Dr gerwerk amp AG compatible 13013118 Isoflurane 5 Standard filler Cagemount 13011218 Isoflurane 5 Standard filler Selectatec Interlock compatible 13012218 Isoflurane 5 Standard filler Dragerwerk AG compatible 13013218 Halothane 5 Keyed filler Cagemount 13021118 Halothane 5 Keyed filler Selectatec Interlock compatible 13022118 Halothane 5 Keyed filler Dragerwerk AG compatible 13023118 Halothane 5 Standard filler Cagemount 13021218 Halothane 5 Standard filler Selectatec Interlock compatible 13022218 Halothane 5 Standard filler Dragerwerk AG compatible 13023218 Halothane 4 model also available Enflurane 5 Keyed filler Cagemount 13031118 Enflurane 5 Keyed filler Selectatec amp Interlock compatible 13032118 Enflurane 5 Keyed filler Dragerwerk AG compatible 13033118 Enflurane 5 Standard filler Cagemount 13031218 Enflurane 5 Standard filler Selectatec Interlock compatible 13032218 Enflurane 5 Standard filler Dr gerwerk amp AG compatible 13033218 Sevoflurane 8 Keyed filler Cagemount 13061118 Sevoflurane 8 Keyed filler Selectatec Interlock compatible 13062118 Sevoflurane 8 Keyed filler Dragerwerk AG compatible 13063118 Sevofl
3. Note Individual vaporizers may vary slightly from the above performance curves 38 Blease Datum User Manual 7 Performance Variation of output with temperature flow rate 5 L min Air 15 20 25 30 Temperature Deg C Figure 13 Effect of Temperature on Enflurane Output Note Individual vaporizers may vary slightly from the above performance curves Blease Datum User Manual 39 7 Performance The Isoflurane Model Variation of output with flow rate T 22 C Air carrier gas Effect of Flowrate on Performance 6 J T lnscn Y s 4 4 E 3 3 2 2 IV ee ee eee ERR A SS Ss yes ee TESS 0 0 5 5 10 15 Flowrate l min Figure 14 Effect of Flowrate on Isoflurane Output Note Individual vaporizers may vary slightly from the above performance curves 40 Blease Datum User Manual 7 Performance Variation of output with temperature flow rate 5 L min Air 20 25 Temperature Deg C Figure 15 Effect of Temperature on Isoflurane Output Note Individual vaporizers may vary slightly from the above performance curves Blease Datum User Manual 41 7 Performance The Sevoflurane Model Variation of output with flow rate T 22 C Air carrier gas Effect of Flowrate on Performance 6 oO 9 9 9 9 9 amp 9 9 amp 9 9 9 9 amp 9 9 9 9 9 9 9 amp 9 9 9 9 9 9 Oe SERILE RUNI UTE TT TT DT TT E i 4 4 3 E a
4. 2 amp 2 D lcblcEc 1 DIM IIl2lssq2dcc II 0 0 5 5 10 15 Flowrate l min Figure 16 Effect of Flowrate on Sevoflurane Output Note Individual vaporizers may vary slightly from the above performance curves Note The performance of the 8 model can be extrapolated from this graph 42 Blease Datum User Manual 7 Performance Variation of output with temperature flow rate 5 L min Air Sevoflurane 16 20 25 30 Temperature Deg C Figure 17 Effect of Temperature on Sevoflurane Output Note Individual vaporizers may vary slightly from the above performance curves Note The performance of the 8 model can be extrapolated from this graph Blease Datum User Manual 43 7 Performance Temperature Compensation Variations in temperature are compensated for by a variable resistance disc valve in the bypass passage This provides compensation while the vapor izer is used in temperatures between 15 C and 30 C 58 F and 86 F Use in temperatures outside this range may cause the concentration to vary from that indicated by the concentration control Temperature compensation is not immediate so if a sudden temperature change is applied to the vaporizer for instance by moving it from a cold storage room to an operating theatre allow a stabilizing period of two hours before using the vaporizer Barometric Pressure Changes in barometric pressure are not normally clinically significant How ever th
5. SUMMAN MU n 46 Accuracy Of Output sinisa sense cds ro tot erre oce hides 46 Gas Flow Resistance ener tni Ere e emet utens 46 Effects of Back Pressures on Output sss 47 Steady Back Press re cinereae ke ete eal e n SR e tie 47 Effect of IPPV 0n Output 2 2 2 ien etica recen 47 Gas COMPOSILON s cathe oes doncc iecit cn bes fed tad pcd isst urat pe dd e Lu ce Dfii et ed 48 qn t 48 wIiieliiS tem EA 48 Carbon Bloom Alesis Rn an ee 48 Hel e ead 48 8 References ss iicisceassecceiedcecesssxacasacsenenicbecassetacensessicsseceeseidisecaaceaassenseedoeeees 49 cr ee 49 Keyed Filler Interlock System irosesc nann nnani 49 Trademarks and Acknowledgements sse e 49 9 Part NumbBers irrri rrt nna aat u nta sn RESP IEEE RRRRR ena RR Ke RaEere 50 6 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 Combporlents 1 iier enn eean ina steve bachersaseseeeevtes 18 Figtine 4 Fill the VapoFlZer ssi nnana iaa esp uoce 26 Figure 5 Air Return Bubbles crie cete r 26 Figure 6 Remove the Cap eiae cel donde
6. plug and tighten and withdraw the drain funnel 7 Remove the drain funnel from the bottle and reattach the bottle cap 1 in Figure 6 Figure 9 Remove the Drain Plug Reattach the black filler cap before using the vaporizer 28 Blease Datum User Manual 5 Installation 5 Install the Vaporizers Follow the instructions given for the type of vaporizer you want to install Cagemount Model e Selectatec Compatible Interlock Model Dragerwerk AG Compatible Model Install the Cagemount Model Vaporizer The Blease Datum Cagemount vaporizer is fitted with the standard 23mm tapers male inlet on the left and female outlet on the right when viewed from the front There are two M6 threaded studs at the rear of the vaporizer each fitted with a nut and washer to retain the clamp plate and spacers The vaporizer can thus be secured to the backbar of the anesthesia machine You can adjust the distance between the backbar and tapers as required 1 Secure the vaporizer to the backbar of the anesthesia machine using the studs nuts washers and spacers provided 2 Lightly apply an oxygen safe grease such as Fomblin on the tapers 3 Push the gas tubing fully onto the appropriate tapers and tighten the fixing nuts Ensure that all connections are gas tight before using the machine Perform a backbar function test before using the machine as described in the anesthesia machine User Manual For non interlocking cag
7. 3 Orcas GS
8. 5 250 225 114 210 Cagemount Quik Fil 7 3 250 220 137 200 Drager Quik Fil 7 5 250 225 100 185 Concentration Control Halothane Isoflurane and Enflurane Models The control dial is graduated in increments of 0 2 Vol from 0 to 2 Vol and in increments of 0 5 Vol from 2 to maximum 5 Vol 8 Sevoflurane models The control dial is graduated in increments of 0 25 Vol from 0 to 2 Vol and in increments of 0 5 Vol from 2 to 8 Vol The control is marked 0 at the zero off position Do not use the vaporizer when the control is set between zero and the first graduation mark Blease Datum User Manual 21 4 Filling and Draining 4 Filling and Draining a Vaporizer Follow the instructions given for the type of vaporizer you want to fill drain Standard Screw Cap Fill Key Fill e Quik Fil WARNINGS Secure the vaporizer in an upright position while filling and draining either by attaching it to an anesthesia machine or standing it on a flat level surface Do not tip the vaporizer during filling 2 Do not use the anesthetic agent bottle to fill the vaporizer if the bottle is cracked or the filler connector is loose or broken This may result in overfilling or a contaminated agent entering the vaporizer 3 If you are using a new bottle of anesthetic agent check that the tamper proof shrink band is undamaged 4 The vaporizer must be filled only by suitably skilled and trained personnel 5 Do not use the v
9. 75 SET 0 21 SET o te MI 100 10300 ween we uM mw e a b 29 e we i i 1 SEA LEVEL The Sease Datum Vaponzer is calibrated at Ses Level 760 mmHG 1013 mbar Figure 18 Effect of Altitude on Output Composition of the Gas The output of the vaporizer can be affected by the composition of the gas be ing flowing through it The variation is unlikely to be more than 10 of the set concentration vaporizer is maintained between the Minimum and Maximum levels to When the liquid level is low the output may fall Ensure the level in the prevent it operating below the Minimum level Blease Datum User Manual 45 7 Performance Summary Accuracy of Output The delivered concentration of anesthetic agent is accurate to 20 of the set concentration or 5 of the maximum graduation whichever is the greater at sea level at 22 C 3 C Gas Flow Resistance These resistances are measured at a set concentration of zero and ambient air at 22 C 72 F and 1013mBar 14 7psi These are nominal values which will vary when the temperature pressure and concentration control settings are varied Flow Rate omm Resistance emm d 46 Blease Datum User Manual 7 Performance Effects of Back Pressures on Output Steady Back Pressure The use of some downstream components can introduce steady back pres sure not usually exceeding 4kPa with the exception of some ventilators A back pressur
10. Loosen the clamp screw and remove the bottle adaptor from the filler port Replace the slipper block and re tighten the clamp screw Discard anesthetic agent drained from the vaporizer do not reuse Treat discarded agent as a hazardous chemical Blease Datum User Manual 25 4 Filling and Draining Quik Fil Vaporizers Do not tamper with the filling system valve Tampering may cause a vapor and fresh gas leak Filling the Vaporizer 1 Do not tip the vaporizer during the filling 26 Ensure that the drain plug screw located on the lower front of the vaporizer is correctly tightened to prevent loss of liquid agent Check that the vaporizer concentration control is in the off 0 position Remove the yellow protective cap from the anesthetic agent bottle filler checking that the bottle and filler mechanism are not damaged Remove the vaporizer black filler cap 1 and insert the bottle nozzle into the filler hee Rotate the bottle to align the bottle filler nozzle keys 2 with the index slots 3 in the filler block Note the liquid level in the vaporizer sight glass and press the agent bottle fully into the vaporizer filler block Allow the liquid to flow into the vaporizer until the maximum level mark is reached paying continuous attention 7 to the level in the sight glass and the air return O bubbles 4 flowing into the bottle Release the bottle when the vaporizer is full Figure 4 Fill the
11. SPACELABS Healthcare e BleaseDatum Anesthesia Vaporizers User Manual 073 0228 00 REV C Blease Datum Vaporizers User Manual Modifications Label ECOA ECO B PR023022 PR024135 ECOC PR024600 Spacelabs Healthcare Ltd Anesthesia Delivery and Ventilation Division 1 Harforde Court John Tate Road Hertford e G13 7NW United Kingdom Tel 44 0 1992 507700 ud Fax 44 0 1992 501213 C e mail enquiries advsales spacelabs com 01 23 e mail technical advsupport spacelabs com 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 A N Read this User Manual before you operate the anesthesia machine 4 Blease Datum User Manual Table of Contents Table of Contents dici 8 Responsibilites of Manufacturer 8 BleaseDatu m Service PoliCy 5 rto tar eet ted o esee YEr nest e tete nba races 8 Responsibilities Of USO ioni eterne erar hrec toned Er EEEE 8 Contact Information lee ceeded cde ie teens chere eee deeb d 9 Safety SUM MARY ES SEIL DI LLLI E 11 Symbols amp AbbreviatlOris 3 tice rtt iter repente Ret de i aE ETE 14 1 Introduction eoe eren is 15 2 Vaporizer Description niin tnnt en nonna hoan Eur 16 Sel
12. Vaporizer and the continuous stream of bubbles ceases Withdraw the bottle from the vaporizer filler and replace the black filler cap 1 and the yellow cap on the agent bottle DO NOT OVERFILL the vaporizer If the vaporizer is overfilled you must remove it from service operation because you may overfill it Figure 5 Air Return Bubbles Blease Datum User Manual 4 Filling and Draining Draining the Vaporizer To avoid spillage check that the bottle to be used for draining has sufficient capacity for the volume of liquid to be drained Reattach the black filler cap before using the vaporizer Discard anesthetic agent drained from the vaporizer do not reuse Treat discarded agent as a hazardous chemical Remove the cap 1 from the vaporizer filler block S Remove the yellow protective cap from an empty Sevoflurane bottle Figure 6 Remove the Cap Insert the bottle nozzle into the drain funnel Rotate the bottle to align the index slots in the drain funnel 2 with the bottle filler nozzle keys 3 and screw the drain funnel onto the empty bottle Figure 7 Align the Drain Funnel Fully insert the drain funnel into the keyed drain slot 4 in the bottom of the vaporizer filler block Figure 8 Attach the Drain Funnel Blease Datum User Manual 27 4 Filling and Draining 6 Remove the drain plug 5 with the key 6 5 e Continue to drain the vaporizer until empty Close 8 the drain
13. all the Vaporizers eesseeesecsseeeeeeeeeeeeeen enne nennen 29 Install the Cagemount Model Vaporizers es 29 Install the Selectatec Compatible Interlock Model sseeeees 30 Blease Datum User Manual Table of Contents Remove the Selectatec Compatible Interlock Model sesssse 31 Install the Dragerwerk AG Compatible Model sss 31 6 Routine Gare 5 eee nte teen udo ruunaa avys E Ra miadi bas vuni 32 CIS MING 2 ads seep 32 Draininig Halothiarie e nny esate ettet a aiao aao aai iaaa 32 Verify Output Concentration ccrte enean etre dente kon P Ren ehe 33 Ie E 34 Presse Check ziarno etel Era tite ee deer rr 35 T Performance rie tte roni tu rena ER e ka TY Ran RRRRSRREERRDaER Ra RE 36 The Halothane Model cccccccceceencceeeeeeeeneeceeeeeeceaeeeeseseaaeeeeseseeueeeeeeeeeennaees 36 The Enfl rane Model issin cce tenet tace EEEE 38 The Isoflurane Model erepti iret eiie reor repe eerte crore rens 40 The Sevoflurane Model sessi essent tnnt enean 42 Temperature COMPENSATION rici eeann Pese eti aa 44 Barometric Press re uii cnes tcc etui eeu a EUR E EX ERERUR CE LECHE SER E LER ae ees 44 Composition of the Gas oiii te ri ee eit Eo Vena ue laine dae e e ERES 45
14. aporizer if the agent level is not visible in the sight glass or the level is outside of the Max indicators 6 Set the concentration control to zero before filling the vaporizer 7 Check that the anesthetic agent name displayed on the supply matches the name displayed on the front of the vaporizer 22 Blease Datum User Manual 4 Filling and Draining Standard Screw Cap Fill Vaporizers i This type of vaporizer is not available in all markets Filling the Vaporizer Never fill the vaporizer if gases are flowing through the anesthesia machine 1 Unscrew the filler cap and place it somewhere safe to prevent contamination 2 Remove the cap of the supply bottle and fill the chamber slowly and carefully Check the liquid level regularly and stop filling when the liquid reaches the Maximum level mark 3 Check that the seal on the filler cap is in place and intact then replace the cap and tighten it fully to finger tight DO NOT OVERFILL the vaporizer If the vaporizer is overfilled you must remove it from service Do not tip the vaporizer during the filling operation because you may overfill it may cause an incorrect dose to be delivered to the patient and result in Do not use the vaporizer if the filler cap is not replaced correctly This significant pollution levels Draining the Vaporizer Secure the vaporizer in an upright position with the concentration control set to zero before you drain it 1 Unsc
15. ble Model Vaporizer 31 Install the Selectatec Compatible Interlock Model Vaporizer 30 Install the Vaporizers 29 Intermittent Positive Pressure Ventila tion 47 Isoflurane Model 40 K Keyed Filler Interlock System 49 Key Fill Vaporizers 24 Maintenance 32 53 N nitrous oxide 48 Notes 10 O output concentration 45 oxygen 48 P Part Numbers 50 Patient Monitoring 13 Performance 36 Physical Specifications 21 Pre Use Check 35 Principles of Operation 18 Q Quik Fil Vaporizers 26 R References 49 Index Steady Back Pressure 47 Switching On the Vaporizer 20 Symbols amp Abbreviations 14 T teady Back Pressure 47 temperature compensating device 19 Temperature Compensation 44 Trademarks and Acknowledgements 49 V vapor chamber 19 vapor control valve 19 Vaporizer Components 18 Vaporizer Descriptions 16 verification 35 Verify Output Concentration 33 Ww Warning notices 10 Remove the Selectatec Compatible Interlock Model Vaporizer 31 Responsibilities of the Manufacturer 8 Responsibilities of the User 8 Routine Maintenance 32 S Safety Notices 10 Safety Summary 11 Selectatec Compatible Interlock Model Standard Version 17 Selectatec compatible vaporizer 30 Service Policy 8 Sevoflurane Model 42 sight glass markings 16 17 Specifications 21 54 Blease Datum User Manual Tel 1 425 657 7200 Tel 44 0 1992 507700 Fax 1 425 657 7212 Fax 44 0 1992 50121
16. e 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 Co
17. e following formulae and rules should be noted The concentration control is graduated in units of Volume at an assumed barometric pressure of 101 3kPa 14 7psi When the pressure varies the true output will vary according to the formula V S x 101 3 P where V concentration delivered expressed as Vol P atmospheric pressure in kPa S concentration set by concentration control It should also be noted that various makes of monitor can be affected in differ ent ways by changes in altitude Normal variations in barometric pressure can usually be ignored in a clinical situation because the vaporization in the vaporizer and the patient s absorp tion through the lungs is affected in the same way 44 Blease Datum User Manual 7 Performance However variations must be compensated for when a non compensated analyser is used to check the output Also some ventilators can impose a constant back pressure of anything up to 15kPa 150cm H20 which may significantly reduce the output concentration A small increase in output concentration can be produced by intermittent back pressure from a ventilator most noticeably at a low concentration with a low flow rate However the Blease DatumGis designed to comply with the tests specified in the various appropriate Standards with regard to this effect Effect on Output with Change in Altitude Bi SET 7 SET 6 SET 5 SET 4 SET 3 SET 2 SET 1 SET 0
18. e of 4kPa would cause a reduction in delivered Vol as fol lows V S x 101 3 P where V concentration delivered expressed as Vol S set concentration P Patmospheric Pback pressure Therefore in the case of 4kPa V S x 101 3 0 96 S 105 3 This effect can usually be ignored under normal clinical circumstances consulting the Spacelabs Healthcare Global Technical Support The o Do not impose pressures in excess of 50kPa on the device without integrity of the seals may be compromised Effect of IPPV on Output The greatest effects of IPPV Intermittent Positive Pressure Ventilation are at low concentration settings and low flow rates The Blease Datum has been designed to comply with the conditions specified in BS4272 Part 3 1989 Blease Datum User Manual 47 7 Performance Gas Composition The Blease Datum vaporizer is calibrated using air at 5 L min Therefore the concentration control is at its most accurate when air is used The output may vary when the gas composition is changed due to differences in density and viscosity affecting the bypass splitting ratio Air was chosen as the calibration gas because the concentration delivered is then in the middle of the range available for anesthesia Do not use a BleaseDatum vaporizer with anything other than Dry Medical Gases Oxygen The use of oxygen will produce a slight rise in output which is unlikely to ex ceed 15 of the set value or 0 3 volum
19. e percentage The effect is greater at high flows with a smaller change occurring at lower flows Nitrous Oxide The use of nitrous oxide will produce a slight fall in output which is unlikely to exceed 15 in normal conditions Carbon Dioxide At or below the maximum normal concentration of 5 the effect of CO is negligible Helium Helium enriched mixtures are likely to reduce the output concentration of the vaporizer so it is recommended that an analyser be used if accurate concen trations of anesthetic agent are required 48 Blease Datum User Manual 8 References 8 References The Blease Datum vaporizer is designed in accordance with the following Standards General EN 740 1998 Section 105 e BS 4272 Part 3 1989 Sections 13 14 ISO 5358 3 1992 Section 13 ISO 8835 4 e ASTM F 1161 88 Section 12 e CSAZ168 3 1984 Sections 12 15 DIN 13252 Sections 4 9 to 4 13 5 9 to 5 13 Keyed Filler Interlock System CSAZ168 4 M82 DIN 13252 Sections 4 11 5 11 Trademarks and Acknowledgements Abbott isthe Trademark of Abbott Laboratories Quik Fil is a registered trademark of Abbott Laboratories Datum is a registered trademark of Spacelabs Healthcare Limited Selectatec TEC and Ohmeda are registered trademarks of BOC Ohmeda UK Ltd Drager is a Trademark of Dr gerwerk AG PPV and Sigma are registered trademarks of Penlon Ltd Blease Datum User Manual 49 9 Part Numbers
20. ectatec Compatible Interlock Model Standard Version sss 16 Cagemount Model Key Filler Version m ba 17 Principles of OperatlOEi iride ea aea PaL Eea E a aa ei 18 Concentration Control 2 2 2 tinere ee cte triente arai aaa 19 Switching On the Vaporizer i interfecti cedet cns 20 3 Specifications sre Rr RERR ORE AVR RRANRR AIRE RARI RA RXRAKRRKRRERRRRRM Rn UE ERR EK AKR 21 Physical suisse eiecsessteetireieteriie A fel De LR I ILS 21 Concentration Control nee tiet ie nete eerte n det ien AN de bead oe ee 21 Halothane Isoflurane and Enflurane Models esee 21 896 Sevoflurane models eiie trt tereti rd terrre eei pen 21 4 Filling and Draining a Vaporizer eeeeennnm 22 Standard Screw Cap Fill Vaporizers se nanain 23 Filling th VapOFlZer yoresi ekine cre retentu cee cerent ie eerta 23 Draining the Vapoftlzer incite dede dee fed rece cens 23 Key Fill VapolilZ8lis x eit e co to treni esee et bue dire ape ea Eee eeii ka uae 24 Filling the Jorelnra EL n 24 Draining the Vaporlzer i x eere eR Lost Eger id estate wee adi 25 Quik Fil VapOniZers reiecit Ee ERE HIA Fee See PAA ae ian 26 Filling the VapOFlZer 1 nte Ee fin doter teer Ecken 26 Draining the Vaporizer ssssssssssssssesseneenenerennnn nennen nnne 27 5 Inst
21. emount models only one vaporizer should be connected at any time If the vaporizer is fitted with a Selectatec or interlocking Cagemount manifold the interlock function is void if used with a non interlock device GOO Blease Datum User Manual 29 5 Installation Install the Selectatec Compatible Interlock Model Vaporizer The BleaseDatum Selectatec compatible vaporizer incorporates interlock pins to prevent use when another vaporizer is installed This model is compat ible with the Ohmeda TEC 4 TEC 5 TEC 6 and TEC 7 and the Penlon PPV Sigma Selectatec interlock compatible models ONLY N e gt A o OOO Carefully position the vaporizer against the backbar Ensure that the gas connection ports and button plates are aligned correctly Lower the vaporizer onto the backbar and ensure that it is correctly seated Lock the vaporizer into position by pushing down and turning the locking lever on the top fully clockwise to the locked position Ensure that the vaporizer is locked securely to the backbar and that the vaporizer manifold is positioned level with and parallel to the top face of the backbar Ensure correct alignment and engagement of the gas connection ports and button plate before locking the vaporizer Ensure all joints are gas tight before using the machine Perform a backbar function test before using the machine as described in the Anesthetic Machine s User Manual If more tha
22. from service Do not tip the vaporizer during the filling operation because you may overfill it Do not loosen the filler adaptor from the drug container during filling You may overfill the vaporizer GOS 9 Push the filler lever back to its original position 10 Lower the bottle to below the level of the filler port to allow any liquid in the adaptor tube to run back into the bottle 11 Loosen the clamp screw and remove the bottle adaptor from the filler port 24 Blease Datum User Manual 4 Filling and Draining 12 Replace the slipper block into the port and re tighten the clamp screw i It is normal for a small amount of liquid to be spilled as the adaptor is removed from the filler port Draining the Vaporizer Ensure the filler control is turned fully counterclockwise closed Loosen the clamp screw and remove the slipper block Screw the filler adaptor on to the supply bottle and tighten it fully to ensure it is airtight Insert the end of the filler adaptor into the filler port on the vaporizer If an incorrect adaptor has been fitted to the supply bottle it will not be possible to insert it into the port Tighten the clamp screw and ensure the adaptor is secured Keeping the bottle below the level of the filler port open the filler port by pulling the lever clockwise until it stops Once the vaporizer is drained the filler port must be closed by pushing the lever back to its original position
23. igation Spacelabs Healthcare follows highly specified test conditions and methods which are carried out as part of the production process If a hospital requires that calibration verification is performed observe the fol lowing points 1 Due consideration of the above statement should be taken into account 2 The test method should be so designed that it follows closely the clinical conditions of use 3 The sampling technique should be such that it truly represents the output of the unit under test 4 Ifa number of units are to be tested together and a consistent error is observed this is unlikely to be the fault of the vaporizer The reliability and accuracy of equipment and test set up should be considered first 5 Full account of the effects of the carrier gas composition should be considered 6 If results are unexpectedly different from that expected the accuracy of test equipment such as flow meters and analyzers should be questioned and verified 7 When the comparative test is done due consideration of the effects of Altitude and ambient temperature should be allowed for The readings of test equipment and the output of the vaporizer will both vary in sympathy with the conditions All BleaseDatum vaporizers are calibrated at sea level 8 If extremely low readings are recorded on Selectatec fitting units the possibility of a cross leak or leak to atmosphere should be considered before suspecting the vaporize
24. ilution ratio provided by the concentration control and bypass passage R so that the output concentra tion 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 ac cording to the graduations on the dial Blease Datum User Manual 19 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 20 Blease Datum User Manual 3 Specifications 3 Specifications Physical Specifications Vaporizer Weight Capacity Height Width Depth kg ml 25 mm mm mm Selectatec Standard 7 5 250 225 114 200 Cagemount Standard 7 3 250 220 137 190 Drager Standard 7 5 250 225 100 175 Selectatec Key Fill 7 5 250 225 114 200 Cagemount Key Fill Ta 250 220 137 190 Drager Key Fill 7 5 250 225 104 175 Selectatec Quik Fil 7
25. logy in this manual complies with 1504135 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 4 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 o 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 Da
26. mpany Headquarters 5150 220th Ave SE Issaquah WA 98029 USA Tel 1 425 657 7200 in North America 1 800 522 7025 Fax 1 425 657 7212 Spacelabs Healthcare Ltd ud Anesthesia Delivery and Ventilation Division 1 Harforde Court John Tate Road Hertford G13 7NW United Kingdom Tel 44 0 1992 507700 Fax 44 0 1992 501213 e mail enquiries advsales spacelabs com e mail technical advsupport spacelabs com 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 CE The product is labeled with the CE mark and notified body number Blease Datum User Manual 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 termino
27. n one vaporizer is installed check that the interlock mechanism works by switching on each in turn and checking that the other will not function If the interlock fails the faulty vaporizer must be taken out of service The vaporizer dial can be activated without the locking mechanism in place Always ensure the vaporizer is locked into position before use Blease Datum User Manual 5 Installation Remove the Selectatec Compatible Interlock Model Vaporizer 1 Unlock the vaporizer by turning the locking lever on the top fully counterclockwise to the unlocked position 2 Carefully lift the vaporizer upwards until it is clear of the backbar Install the Dragerwerk AG Compatible Model Vaporizer 1 Carefully position the vaporizer against the backbar Ensure the gas connection ports and button plates are aligned correctly 2 Lower the vaporizer onto the backbar and ensure that it is correctly seated 3 Lock the vaporizer into position by turning the locking lever on the top fully clockwise to the locked position 4 Ensure that the vaporizer is locked securely to the backbar and that the vaporizer manifold is positioned level with and parallel to the top face of the backbar Ensure all connections are gas tight before using the machine Perform a backbar function test before using the machine as described in the anesthesia machine User Manual Blease Datum User Manual 31 6 Maintenance 6 Routine Ca
28. nesthesia 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 Blease Datum User Manual 15 2 Vaporizer Description 2 Vaporizer Descriptions Selectatec Compatible Interlock Model Standard Version Figure 1 Key O Concentration Control Level Indicator Interlock Pins Locking Valve Drain Plug Filler Cap 2 x r o m 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 16 Blease Datum User Manual 2 Vaporizer Description Cagemount Model Key Filler Version Figure 2 Key Inlet Connector Outlet Connector O 0 gt Concentration Control D Filler Port Clamp E Filler Valve Control Level Indicator Filler Port
29. orted 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 e 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 gt 1500 meters See section 7 The barometric
30. 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 Drager or interlocking Cagemount manifold the interlock function is void if used with a non interlock 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 anes
31. r 9 Ifin doubt please contact Spacelabs Healthcare Global Technical Support Blease Datum User Manual 33 6 Maintenance Service Training Spacelabs Healthcare offers a training course for engineers and technicians who are required to service BleaseDatum vaporizers The course includes Leak testing Seal replacement Internal cleaning Major sub assembly replacement Output regulation The BleaseDatum Technical Manual contains a description of all the above procedures 34 Blease Datum User Manual 6 Maintenance Pre Use Check Before using the vaporizers perform the following verifications 1 Check that the vaporizer s for the required volatile agent s are installed correctly to the anesthesia machine that any backbar locking mechanism is fully engaged and that the control valve s rotate through their full range s Turn off the vaporizer s Check that the flow through each vaporizer is in the correct direction When filling each vaporizer ensure that the correct anesthetic agent is used and that the filling port is left tightly closed For machines that are fitted with a pressure relief valve perform the following tests Do not perform these tests if the valve is not installed There may be a dangerous increase in pressure if these tests are performed in the absence of a pressure relief valve a Seta suitable test flow of oxygen 6 8 L min and with the vaporizer in the off posi
32. re Do not attempt any adjustment or disassembly of the vaporizer outside the scope of the following instructions Cleaning Clean the exterior of the vaporizer using a clean damp cloth only Draining Halothane The Halothane versions of the Blease Datum should be drained at intervals weekly if in regular use and the liquid disposed of as a hazardous chemical This is because Halothane contains a stabilizing agent 0 1 thymol which is only slightly volatile and will accumulate in the vaporizer eventually causing the output concentration to decrease The concentration of thymol may also have clinically deleterious effects on the patient see Rodenburg Alila Anaes thesia 1984 38 581 583 exposed to light and gases for long periods Discolored anesthetic agents must not be used and should be disposed of as a hazardous chemical Anesthetic agents may suffer from brown or yellow discoloration if All vaporizers should be drained of anesthetic agent if not in regular use and the liquid disposed of as a hazardous chemical 32 Blease Datum User Manual 6 Maintenance Verify Output Concentration The performance of a vaporizer in clinical use is monitored by observing pa tient signs and consumption of anesthetic agent Some hospitals may have a policy of a comparison check against an anesthetic agent analyser to deter mine any variation from normal This check may be carried out routinely or as part of a periodic invest
33. rew the filler cap 2 Place a suitable receptacle under the drain plug to catch the liquid 3 Use the bar in the bottom of the cap to undo the drain screw at least two turns and allow all the liquid to drain into the receptacle Blease Datum User Manual 23 4 Filling and Draining 4 Fully tighten the drain screw then replace the filler cap Tighten the drain plug securely before replacing the filler cap Discard anesthetic agent drained from the vaporizer do not reuse Treat discarded agent as a hazardous chemical Key Fill Vaporizers Filling the Vaporizer 1 Ensure that the filler control is turned fully counterclockwise closed 2 Loosen the clamp screw and remove the slipper block from the filler port 3 Screw the filler adaptor on to the supply bottle and tighten it fully to ensure it is airtight 4 Insert the end of the filler adaptor until it stops into the filler port on the vaporizer If an incorrect adaptor has been fitted to the supply bottle it will not be possible to insert it into the port 5 Tighten the clamp screw and ensure that the adaptor is secured 6 Raise the bottle to a level above the filler port so that any air in the bottle cannot enter the filler tube Open the filler control port by pulling the lever clockwise until it stops Fill the chamber to the required level shown on the indicator eo NI DO NOT OVERFILL the vaporizer If the vaporizer is overfilled you must remove it
34. tee ceto ira b roe abes 27 Figure 7 Align the Drain Funnel sssssssssseeeneeeeen nnne 27 Figure 8 Attach the Drain Funnel aceeceeceiiieeeeeen enitn tenentes 27 Fig re 9 Remove the Drain Pllig 2 ioo eene etie itr oen hne reprae 28 Figure 10 Effect of Flowrate on Halothane Output eee 36 Figure 11 Effect of Temperature on Halothane Output 37 Figure 12 Effect of Flowrate on Enflurane Output sene 38 Figure 13 Effect of Temperature on Enflurane Output 39 Figure 14 Effect of Flowrate on Isoflurane Output seen 40 Figure 15 Effect of Temperature on Isoflurane Output sessssssssss 41 Figure 16 Effect of Flowrate on Sevoflurane Output sese 42 Figure 17 Effect of Temperature on Sevoflurane Output eeesssss 43 Figure 18 Effect of Altitude on Output sssese emm 45 Blease Datum User Manual 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 adjust ments 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 Tech nical Support personnel Th
35. thetist 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 Blease Datum User Manual 13 cmH O co L pm ml psi kPa mBar Nol E 14 Symbols amp Abbreviations Gauge pressure expressed in centimetres of water Oxygen Carbon Dioxide liters per minute milliliter pounds per square inch Kilopascals millibars Percent concentration of agent per total volume Date of Manufacture Manufacturer Confers approval under the Euro pean Medical Device Directive and the notified body number Caution Caution Attention see instructions for use WARNING There is danger of per sonal injury to the user or patient Further relevant or helpful informa tion Unlocked Locked Federal law restricts this device for sale by or on the order of a physician Filling Push in to turn Do not tip when charged Blease Datum User Manual 1 Introduction 1 Introduction The BleaseDatum Vaporizer is intended for use in the fresh gas supply of a continuous flow a
36. tion temporarily occlude the common gas outlet There should be no leak from any of the vaporizer components and the flowmeter bobbin will dip b Repeat this test with each vaporizer in the on position There should be no leak of liquid from the filling port 5 Turn off the vaporizer s and the oxygen flowmeter control valve Blease Datum User Manual 35 7 Performance 7 Performance The Halothane Model Variation of output with flow rate T 22 C Air carrier gas Effect of Flowrate on Performance Halothane 05 5 19 15 Flowrate l min Figure 10 Effect of Flowrate on Halothane Output Note Individual vaporizers may vary slightly from the above performance curves 36 Blease Datum User Manual 7 Performance Variation of output with temperature flow rate 5 L min Air Effect of Temperature Halothane Figure 11 Effect of Temperature on Halothane Output Note Individual vaporizers may vary slightly from the above performance curves Blease Datum User Manual 37 7 Performance The Enflurane Model Variation of output with flow rate T 22 C Air carrier gas Effect of Flowrate on Performance 6 ts OO oO 9 o4 amp 9 9 o3 9 9 9 9 9 o4 o 9 o 9 4 9 bo 9 C i E 4 4 E i t 3 2 i TT Pe ete E t P P PPPrC T 4 4 0 0 5 5 10 15 Figure 12 Effect of Flowrate on Enflurane Output
37. tum 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 Blease Datum User Manual 11 Safety Summary 8 Inthe 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 fthe vaporizer has been transp
38. urane 8 Standard filler Cagemount 13061218 Sevoflurane 8 Standard filler Selectatec Interlock 13062218 compatible Sevoflurane 8 Standard filler Dragerwerk AG compatible 13063218 50 Blease Datum User Manual 9 Part Numbers Description Part Number Isoflurane key filler bottle adaptor 10010001 Halothane key filler bottle adaptor 10020001 Enflurane key filler bottle adaptor 10030001 Sevoflurane key filler bottle adaptor 10040001 Blease Datum User Manual 51 52 Notes Blease Datum User Manual Index Index A About This Manual 10 Accuracy of Output 46 Air 48 B back pressure 47 Barometric Pressure 44 bypass valve 19 C Cagemount Model Key Filler Version 16 Cagemount vaporizer 29 calibration gas 48 Carbon Dioxide 48 Caution Notices 10 Cleaning 32 compensation 44 Composition of the Gas 45 concentration control 19 44 48 Concentration Control 19 21 D dilution ratio 19 Dr gerwerk amp AG Compatible Model Vaporizer 31 Draining Halothane 32 Draining the Vaporizer 23 25 27 E Effect of IPPV on Output 47 Effects of Back Pressures on Output 47 Enflurane Model 38 Blease Datum User Manual F Filling and Draining a Vaporizer 22 Filling the Vaporizer 23 24 26 G Gas Composition 48 Gas Flow Resistance 46 H Halothane 32 Halothane Model 36 Helium 48 Install the Cagemount Model Vapor izer 29 Install the Dragerwerk AG Compati
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