Sigma Delta User Manual
Contents
1. To obtain the true concentration of gases other than halothane multiply the reading shown on the Riken analyser by the correction factors given below Carrier Gas The 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 by multiplying the Riken scale reading to obtain the true concentration Correction Factors Halothane in Air Riken Factor using air Factor using oxygen Halothane 1 1 06 Enflurane 1 05 1 11 Isoflurane 1 06 1 12 Sevoflurane 1 05 1 10 43 SERVICE RECORDS Halothane in Oxygen Riken Factor using air Factor using oxygen Halothane 0 95 1 Enflurane 0 99 1 05 Isoflurane 1 1 06 Sevoflurane 0 99 1 05 Temperature and Barometric Pressure Calibration checks must be performed at a temperature between 19 and 21 C The correction factor is 1 5 of readings which is negligible in view of the accuracy of the instrument Temperature correction is therefore not required but the temperature should be measured and recorded to ensure that the test is carried out within the specified range Changes of barometric pressure due to weather are not normally of significance and can be ignored Altitude can however have significant effects and the following correction factors should be applied when appropriate The Riken reading multiplied by the stated correction factor giv2. 8 2 Cleaning and Sterilisation WARNING Do not pour water or any cleaning solutions into the vaporizer The process of filling and emptying will clean the internal passageways of the vaporizer filler block satisfactorily The exterior of the vaporizer should be kept clean and dust free with a dry cloth or if necessary use proprietary cold sterilised wipes Do not use water or other liquids 8 3 Draining Halothane Models Because halothane contains a stabilising agent which is only slightly volatile 0 1 thymol the vaporizer chamber should be drained periodically of all liquid and the liquid disposed of as a hazardous chemical If the vaporizer is not drained periodically the stabilising agent will accumulate in the vaporizer and eventually cause low output There is some evidence that high levels of accumulated thymol can have clinically undesirable effects on the patient Ref Rosenburg Alila Anaesthesia 1984 38 581 583 38 If the vaporizer is in regular use this draining operation should be performed weekly WARNING Prolonged exposure of anaesthetic agents to light and gases may lead to a brown or yellow colouration Discoloured liquid and or liquid drained from a vaporizer must not be used and should be disposed of as a hazardous chemical 8 4 Checking Vaporizer Output The output of the vaporizer should be checked periodically either i as part of the Penlon Service C
3. E mail uksales penlon co uk
4. Penlon Sigma Delta Vaporizer User Instruction Manual This manual contains calibration and service records for Sigma Delta Vaporizer Serial No Keep this manual with the vaporizer at all times Quality and Assurance in Anaesthesia WARNING Anaesthetic systems have the capability to deliver mixtures of gases and vapours to the patient which could cause injury or death unless controlled by a qualified anaesthetist There can be considerable variation in the effect of anaesthetic drugs on individual patients so that the setting and observation of control levels on the anaesthesia systems does not in itself ensure total patient safety Anaesthesia system monitors and patient monitors are very desirable aids for the anaesthetist but are not true clinical monitors as the condition of the patient is also dependent on his respiration and the functioning of his cardio vascular system IT IS ESSENTIAL THAT THESE ELEMENTS ARE MONITORED FREQUENTLY AND REGULARLY AND THAT ANY OBSERVATIONS ARE GIVEN PRECEDENCE OVER MACHINE CONTROL PARAMETERS IN JUDGING THE STATE OF A CLINICAL PROCEDURE IMPORTANT Servicing and Repairs In order to ensure the full operational life of the Sigma Delta vaporizer we recommend that a periodic service check should be performed by a Penlon trained engineer This check comprises a vaporizer CALIBRATION CHECK and LEAK CHECK Note a The calibration check must be performed using a s
5. engineers and hospital staff who wish to carry out routine maintenance on vaporizers The course covers leak testing replacement of seals internal maintenance replacement of major subassemblies regulation of output A manual describing this work is available to personnel who have undergone this course 8 6 Returning the Vaporizer for Service or Repair The vaporizer must be drained and allowed 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 screw and withdraw the plug see section 5 1 This will prevent possible damage to the filler block seal 9 REFERENCES Standards The Sigma Delta vaporizer has been designed in accordance with the following Standards a General BS 4272 Part 3 1989 Sections 13 14 ISO 5358 1992 Sections 12 13 14 IEC 60601 2 13 ASTM F1 161 1988 Section 12 CSA CANS 2168 3 M84 Section 12 DIN 13252 Sections 4 9 4 13 and 5 9 5 13 b Agent Specific Keyed Filling System CSA CAN3Z 168 4 M83 DIN 13252 Sections 4 11 and 5 11 ISO 5360 1993 Trademarks Selectatec is a Datex Ohmeda trademark Modura is an S amp W trademark 40 10 ORDERING INFORMATION A wide range of Halothane Enflurane Isoflurane and Sevoflurane vaporizers are available Various combinations of agent concentration output and connector block type are available with
6. vaporizer it must be checked and serviced to at least the minimum standards laid out in this manual A defective or suspected defective product must not under any circumstances be used The user must accept responsibility for any malfunction which results from non compliance with the servicing requirements detailed in section 8 1 Worn broken distorted contaminated or missing components must be replaced immediately Should such a repair become necessary it is recommended that a request for service advice is made to the nearest Penlon service centre This vaporizer and any of its constituent parts must be repaired only in accordance with written instructions issued by Penlon Limited and must not be altered or modified in any way without the written approval of Penlon Limited The user of this equipment shall have the responsibility for any malfunction which results from improper use maintenance repair damage or alteration by anyone other than Penlon Limited or its appointed agents This vaporizer must only be supplied to and used by suitably qualified medical practitioners In the USA and Canada Caution Federal Law restricts this device to sale by or on the order of a physician Statements in this manual preceded by the following words are of special significance WARNING means there is a possibility of personal injury to yourself or others CAUTION means there is a possibility of damage to th
7. 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 only Use with corresponding agent specific bottle 10 SPECIFICATION 4 5 Control Dial Scale The control dial is marked as follows From 0 to 2 vol by intervals of 0 2 vol From 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 35 C 58 to 95 F Storage Temperature Range 20 to 50 C 5 to 1220F Storage in Transit up to 7 days 40 to 60 C 40 to 1490F 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 11 5 5 1 Key Filler System WARNING The vaporizer must be either secured to the anaesthetic machine or free standing on a level table so that in either case it is upright during the filling process Overfilling may occur if the vaporizer is tipped during the filling process WARNING The vaporizer concentration control must be in the 0 zero position during the filling process Provided this is done gas may continue to be deliv ered f
8. 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 ataUmin Comments 52 SERVICE RECORDS Year Four Ts Pe eT Signature Print name Leak Test at 200 mmHg for minimum 60 secs Pressure must not drop below 180 mm Hg 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 ataUmin Comments 53 SERVICE RECORDS Year Five Ts Pe eT Signature Print name Leak Test at 200 mmHg for minimum 60 secs Pressure must not drop below 180 mm Hg 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 ataUmin Comments 54 SERVICE RECORDS Year Six Ts Pe eT Signature Print name Leak Tes
9. contaminated agent entering the vaporizer If a new bottle of anaesthetic agent is to be used check that the tamper evident shrink band is undamaged Ensure that the drain plug screw located on the lower front of the vaporizer is correctly tightened to prevent loss of liquid agent Do not tamper with the filling system valve This may cause a vapour and fresh gas leak Anaesthesia system monitors and patient monitors are very desirable aids for the WARNINGS AND CAUTIONS 15 16 17 anaesthetist but are not true clinical monitors as the condition of the patient is also dependent on his respiration and the functioning of his cardiovascular system Do not overfill A vaporizer that has been overfilled must be withdrawn from use Contact the Service Department at Penlon for advice Anaesthetic drugs must be treated as a pharmaceutical product Liquid should never be drained from a vaporizer into an open container and then reused Contamination is likely Always dispose of such drained liquid as a hazardous chemical After filling or draining Pour Fill Screw cap filler always refit and retighten the filler cap Key agent specific filler models always tighten the filler control In addition on key filler systems always refit the key filler plug and tighten the clamp screw before using the vaporizer The vaporizer will leak if this is not done Quik Fil models
10. excess liquid agent will spill from the drain hole in the keyed slot in the filler block DO NOT REUSE THIS AGENT Allow all the excess liquid to drain from the vaporizer 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 the bottle adaptor to flow back into the bottle Loosen the clamp screw 4 remove the bottle adaptor from the receiver NOTE A small amount of liquid is always likely to spill when the bottle adaptor is removed from the receiver 13 FILLING AND DRAINING 10 Insert the plug 5 and tighten the clamp screw 4 WARNING For the vaporizer to function cor rectly it is important to insert the sealing plug 5 fully until it stops before clamping it into position with the clamp screw 4 after filling is completed If this is not done the possibility exists that agent may leak from the vaporizer or the vaporizer may not pressurise properly giving reduced concentration output and gas flow to the patient 14 FILLING AND DRAINING Draining the Vaporizer CAUTION To reduce atmospheric pollution in the operating room it is recom mended that vaporizer drainage should be performed in a fume cupboard or under an extractor hood WARNING The vaporizer must be either secured to the anaesthetic machine or free standing on a level table so that in either case it is upright during the draining proc
11. the Vaporizer Rotate the locking lever fully anticlockwise and carefully lift the vaporizer from the manifold INSTALLATION 6 6 North American Drager Compatible Interlock Installation 1 Check that each gas port 1 is fitted with the correct O seal as supplied by the anaesthetic machine manufacturer Drager part No M21929 Carefully offer the vaporizer up to the manifold To secure the vaporizer to the manifold use two M4 x 30 screws DIN 912 Property Class 8 8 and fan type lock washers as supplied with the machine From the rear of the anaesthetic machine fit the two screws through the manifold block holes 2 and screw into the threaded holes in the vaporizer Tighten the screws to a torque of 2 7 to 3 0 Nm Pre use Checks Carry out the check list procedure given in section 6 7 Removing the Vaporizer 1 2 3 Support the vaporizer and remove the securing screws Detach the vaporizer from the manifold Check that the O seals are retained in the gas ports 1 26 INSTALLATION 6 7 Pre Use Check List In addition to the pre use warnings listed for different models in sec tions 6 2 to 6 6 the following check list procedure must be carried out on ALL vaporizers before use 1 Check that the vaporizer concentration control is in the O zero position 2 Check that the liquid level is between the upper and lower marks on the filler block 3 On key fill a
12. ventilators or other parts of the anaesthetic apparatus are usually relatively small but cer tain ventilators can impose steady back pressures of 10 to 15 kPa 100 to 150 cmH20 which will pro duce a reduction of the output con centration 7 3 3 Intermittent Back Pressure Intermittent back pressure imposed on the vaporizer by a ventilator may result in some change in out put The effect is greatest at low settings of the control and low flow rates and the Sigma Delta vaporiz er is designed to comply with the tests laid down in various Standards in this respect see sec tion 9 PERFORMANCE CHARACTERISTICS 7 4 Summary of Performance Specifications 7 41 Factors Affecting Output Accuracy The following conditions may affect the accu racy of the vaporizer Column A in the table shown below lists the design limits for normal use Column B lists extreme conditions and if nec essary indicates when the vaporizer may be used reliably only after reference to the sec tions of the manual indicated Under the conditions listed in column A the maximum deviation from the set concentration is 20 of scale reading or 5 of the maxi mum graduation whichever is greater i 2 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 18 MIN and MAX marks Temperature 15 to 35 C 10 to 15 C and 35 to 40 C s
13. zero position during the draining process 1 Check that the vaporiz er concentration control 1 is in the O zero position as illustrated 2 Unscrew the filler cap 2 3 Place a bottle marked with the drug name on the vaporizer under the drain tube in the base of the filler block and undo the drain screw 8 at least three full turns WARNING Anaesthetic drugs must be treat ed as a pharmaceutical product Liquid should never be drained from a vaporizer into an open 17 container and reused Contamination is likely Always dispose of such drained liquid as a hazardous chemical 4 Allow the liquid to run into the bottle until the flow ceases Close the drain screw 3 CAUTION Always close the drain screw firmly before replacing the filler cap on the vaporizer FILLING AND DRAINING 5 3 Quik Fil System WARNINGS Do not use the anaesthetic agent bottle to fill the vaporizer if the bottle is cracked or the filler con nector is loose or broken This may result in overfill ing or contaminated agent entering the vaporizer If a new bottle of anaesthet ic agent is to be used check that the tamper evi dent shrink band is undam aged Firmly secure the vaporizer in a vertical position before filling Ensure that the drain plug screw located on the lower front of the vaporizer is correctly tightened to pre vent loss of liquid agent Do not tamper with the fill ing s
14. CHARACTERISTICS Performance Graphs Halothane Models Enflurane Models Isoflurane Models Sevoflurane Models Temperature Compensation iii E 10 10 10 10 11 11 11 11 11 12 15 18 21 21 23 24 25 26 27 28 29 30 31 32 33 CONTENTS 7 3 7 3 1 7 3 2 7 3 3 7 4 7 4 1 7 4 2 7 5 7 6 7 7 7 8 8 1 8 2 8 3 8 4 8 5 8 6 10 11 11 1 11 2 11 3 11 4 Pressure Effects Ambient Pressure Back Pressure Intermittent Back Pressure Summary of Performance Specifications Factors Affecting Output Accuracy Resistance to Gas Flow Effect of IPPV on Output Effect of Gas Composition on Output Output when Control is at O Zero Effect of Flush Valve Operation USER MAINTENANCE Servicing Cleaning Draining Halothane Models Checking Vaporizer Output Training Course Returning the Vaporizer for Service or Repair REFERENCES ORDERING INFORMATION SERVICE RECORDS Service Policy Calibration Procedure using the Riken Analyser Servicing and Repair Details Calibration Check iv 33 33 33 33 34 34 35 35 35 35 36 37 38 38 38 39 39 40 41 42 43 46 50 USER RESPONSIBILITY This vaporizer has been built to conform with the specification and operating procedures stated in this manual and or accompanying labels and notices when checked assembled operated maintained and serviced in accordance with these instructions provided To ensure the safety of this
15. ation Maximum storage temperature 50 C 1220F Minimum storage temperature 20 C 5 F Operating temperature range 15 to 35 C 58 to 95 F Before use function test any vaporizer that has been subjected to temperatures near the upper lower limits given above WARNINGS AND CAUTIONS Filling and draining the vaporizer 6 The filler system must be maintained in accordance with the instructions given in the User Maintenance section The vaporizer must be filled only by suitably skilled and trained personnel Anaesthetic drugs are poisonous and there is evidence that there is a health hazard to personnel due to prolonged inhalation of trace concentration in the atmosphere Care must be taken to avoid spillage of anaesthetic drugs when filling or draining vaporizers The vaporizer control must be in the 0 zero position during the filling or draining process Overfilling and or spilling may occur if the control is not in the 0 zero position Provided the control is in the 0 zero position gas may continue to be delivered from the anaesthetic machine to 10 11 12 13 14 the patient during the filling procedure The vaporizer must be upright during filling to minimise the risk of overfilling Do not use the anaesthetic 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
16. cessive figures a trend in performance can be established and a service performed before the standard tolerance is exceeded c If the calibration check shows a departure from the standard performance or a trend towards predicted failure the vaporizer must be serviced as described in the service manual d All vaporizers must be overhauled every ten years Halothane models every five years and certain items replaced even if the performance appears satisfactory This is a preventive maintenance requirement e Record repair and servicing work carried out on the vaporizer in section 11 3 of this book 42 SERVICE RECORDS 11 2 Calibration Procedure using the Riken Analyser The Riken Model 1F 18 is normally calibrated by the manufacturer for measuring up to 8 vol Halothane or up to 9 Sevoflurane either in air or in oxygen Service checks on the vaporizer must be performed with oxygen if the vaporizer is checked on an anaesthetic machine Use air or oxygen if the vaporizer is checked in a test laboratory CAUTION A It is essential that the gas used during service checks is recorded B The reference cell of the Riken must be purged with the appropriate gas before measurements are made Agents The Riken gas analyser measures the refractive index of the gases and vapours and although normally calibrated for measuring halothane the instrument can also measure other vapours if an appropriate correction factor is applied
17. e instrument or other property NOTE indicates points of particular interest for more efficient and convenient operation The reader must take particular notice of the warnings cautions and notes printed throughout the manual 1 WARNINGS AND CAUTIONS The following Warnings and Cautions must be read and understood before using this vaporizer WARNINGS General Information 1 The user must read and be familiar with the contents of this instruction manual before using the vaporizer The vaporizer is designed for use only with the specific anaesthetic agent named on the filler block and further indicated by colour coded labelling Misdosage may occur if the vaporizer is filled with the wrong drug Agent specific keyed filler devices are provided on certain models to meet national and international standards See section 9 for standards The pharmacopoeia name of the drug is used on the label according to BP USP or Ph EUR The user is responsible for confirming that any trade name of a drug is equivalent to the registered name This vaporizer must not be modified or disassembled by an unauthorised person It should be regularly serviced by a Penlon authorised service agent trained technician or engineer and by no other person see section 8 Vaporizers may malfunction if exposed to excessively high temperatures e g by storage above a radiator This may affect the calibr
18. eathing system Expired anaesthetic vapours should be extracted from the theatre by an anaesthetic gas scavenging system see section 9 for Standards Do not use the vaporizer with flammable anaesthetics User Maintenance 31 Do not pour water or any cleaning solutions into the vaporizer 1 CAUTIONS Anaesthetic machine and workstation standards require that means be provided to ensure that gas cannot pass through more than one vaporizer chamber Vaporizers without interlock devices or systems must only be used on machines which only have one vaporizer mounting station 2 PURPOSE The Sigma Delta vaporizer is designed for incorporation in the fresh gas supply system of continuous flow anaesthetic machines directly connected between the flowmeter unit and the common gas outlet of the machine The vaporizer is unsuitable for use within a breathing system in circuit because of the relatively high internal resistance Its purpose is the provision of accurate concentrations of anaesthetic drugs in the fresh gas supply in accordance with the setting of the control dial when the fresh gas supply flow is between 0 2 and 15 litres min Refer to section 7 Performance Characteristics which shows the extent of modifications to the control calibration 3 DESCRIPTION 3 1 Operating Principles Each model is uniquely designed and tested for use only with the drug specified on the filler bl
19. ection 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 at 5 L min before use See section 1 WARNING 20 The combination of high altitude and high temperature may lead to loss of accuracy 34 PERFORMANCE CHARACTERISTICS 7 4 2 Resistance to Gas Flow Resistance to gas flow measured at 220C 72 F 101 3 kPa 1013 mbar or 14 7 psi Control position 0 zero Flow Rate Resistance using Air cmH2O L min 1 1 8 2 3 4 4 8 0 8 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 the nominal value for Sevoflurane at 4 L min air is 12 cmH20 7 5 Effect of IPPV on Output For 2 kPa IPPV at a flow rate of 2 L min output concentration will vary by up to 20 For 5 kPa IPPV at a flow rate of 8 L min output concentration will vary by up to 10 35 7 6 Effect of Gas Composition on Output The vaporizer is calibrated with pure oxygen and the scale is there fore most accurate with this gas The effect of other gases normally used in anaesthesia is as follows Nitrous oxide Nitrous oxide added to oxy
20. ed with the valve capsule cartridges on the vaporizer before tightening the locking lever Pre use Checks Observe the WARNING below and carry out the check list procedure given in section 6 7 WARNING Test all joints for gas tightness before using the anaesthetic machine The locking lever MUST be in the locked position before the vaporiz er is operated 22 Removal NOTE The concentration control dials of all the vaporizers linked by the interlock system must be turned to zero before removing the vaporizer from the manifold To remove the vaporizer rotate the locking lever 90 anti clockwise and carefully lift the unit vertically until clear of the back bar INSTALLATION 6 3 Cagemount 23 mm Taper Models CAUTION It is recommended that this type of vaporizer should only be used on machines with a single vaporizer mounting station Vaporizers fitted with cagemount tapers have the male taper 1 Inlet port on the left and the female taper 2 on the right viewing the front of the vaporizer Two M6 studs with nuts washers and a clamp plate 3 are provided to fix the vaporizer to the back of the anaesthetic machine or Modura claw assembly Taper Connectors It is essential that the taper cone joints should be engaged axially and not sideways loaded 1 Adjust the distance from the back bar to the taper joint by adding or removing the shims 4 2 The cone joints should be lightly s
21. either agent specific filler screw cap and Quik Fil filler systems For further information Contact your distributor or Customer Service at Penlon Ltd UK Tel 01235 547036 Fax 01235 547023 E mail uksales penlon co uk International Export Tel 44 1235 547001 Fax 44 1235 547021 E mail export penlon co uk 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 bottles 53453 Agent Specific Keyed filler adaptor for isoflurane bottles 53454 Agent Specific Keyed filler adaptor for sevoflurane bottles 41 11 SERVICE RECORDS 11 1 Service Policy The Sigma Delta Vaporizer must be serviced according to the following system a The calibration should be checked periodically under controlled conditions and leak tests performed For further information Penlon trained engineers should refer to the relevant section in the the service manual The measured figures should be recorded in section 11 4 of this book At the completion of each Ten Year Overhaul five year overhaul for Halothane models a copy of the completed calibration records in section 11 4 must be faxed to Penlon Limited Fax No 44 1235 547062 b By comparing several sets of suc
22. er filler and replace the vaporizer filler block cap and the yellow cap on the agent bottle WARNING The filler cap must be refitted before using the vaporizer 19 FILLING AND DRAINING Quik Fil System Draining the vaporizer WARNING To avoid spillage check that the bottle to be used for draining has sufficient capacity for the volume of liquid to be drained 1 Remove the yellow protective cap from an empty sevoflurane bottle Insert the bottle nozzle into the drain funnel Rotate the bottle to align the bottle filler keys with the index slots in the drain funnel and screw the drain funnel onto the empty bottle 2 Remove the vaporizer filler block cap 3 Fully insert the drain funnel into the keyed drain slot and unscrew the drain plug Continue to drain the vaporizer until empty Close the drain plug and tight en and withdraw the drain fun nel 4 Unscrew the drain funnel from the bottle and refit the bottle cap and the vaporizer filler block cap WARNING The filler cap must be refitted before using the vaporizer WARNING Do not reuse the agent drained from the vaporizer Treat as a hazardous chemical 20 6 INSTALLATION 6 1 Gas Port Transit Seals All vaporizers CAUTION Inlet and outlet ports are sealed for delivery transit Ensure that these seals are removed from the vaporizer before installation on an anaesthetic machine 6 2 Selectatec Compatible Models with Int
23. erlock These vaporizers are designed for installation on a _ Selectatec Universal Series type manifold back bar and can also be used on the Type 3 Manifold NOTE When installing two vaporizers only on a three station manifold the centre station must be occupied by one of the vaporizers WARNING Anaesthetic machine designs are constantly evolving and new models may differ dimensionally from existing equipment It is the user s responsibility to ensure that the configuration of the anaesthetic machine allows correct installation of the vaporizer There must be sufficient clearance between the Selectatec manifold 21 1 Locking Lever 2 Interlock Bolts 3 Back Bar Manifold Locking Shaft and the rear panelling frame of the machine to allow the vaporizer connector block to seal correctly on the manifold INSTALLATION Installation 1 Carefully offer the vaporizer up to the manifold 2 Align the gas connection ports with the valve capsule on the manifold The cap sule is referred to as the valve cartridge in some user literature 3 Carefully lower the vaporiz er onto the manifold and recheck that the gas ports are correctly engaged with the valve capsule cartridges on the manifold 4 Lock into position by push ing the locking lever down wards and rotating clock wise through 90 CAUTION To prevent damage to the locking shaft recheck that the gas ports are correctly engag
24. ero the dial assembly will automatically spring outwards into the locked off position Interlock Models When the vaporizer is mounted on the anaesthetic machine back bar with other interlock vaporizers ini tial operation of the concentration control dial activates the interlock system ensuring that only one of the vaporizers con be in use at any time The interlock deactivates as soon as the control dial is returned to the locked out zero position NOTE The Sigma Delta Selectatec Compatible Vaporizer with Interlock can be used on a Selectatec Universal Series Manifold back bar in conjunction with other types of Selectatec com patible vaporizers i e from other manufacturers fitted with the inter lock function WARNING The Drager compatible model with interlock must only be used with other Drager compatible interlock vaporizers to maintain the integrity of the interlock sys tem 4 SPECIFICATION 4 1 Physical Dimensions Width Height Depth Cagemount 133 219 158 Selectatec Compatible with Interlock 120 242 190 Drager plug in Compatible 100 242 190 Dimensions given above are in millimetres NOTE For 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 NOTE After draining approximately 60 10 ml of liquid is retained by the wick
25. es the true concentration corrected to Standard Temperature and Pressure STP Altitude Factor Barometric Pressure for reference 600m 2000 ft 0 9 910 mb 1200 m 4000 ft 0 85 850 mb 1800 m 6000 ft 0 8 813 mb Method of reading the Riken Analyser 1 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 absorb vapours 44 SERVICE RECORDS Rubber sleeves may be used to make end connections but there must be minimal length of rubber exposed to the gases being sampled 3 Sample by 2 or 3 squeezes of the hand bulb Wait for fringe movement to cease before taking the reading 4 After each resetting of the vapour control time must be allowed for the 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 its correct operating position b Temperatures must be stabilised for approximately 4 hours before checking c The temperature must be in the range 19 to 21 C 45 SERVICE RECORDS 11 3 Servicing and Repair Details Give details of any servicing component replacements etc carried out on the vaporizer Date Comments including any additional work Signature SERVICE RECORDS Date Comments inc
26. ess WARNING The vaporizer concentration control must be in the 0 zero position during the draining process 1 Check that the vaporizer concentration control 1 is in the O zero position 2 Follow steps 2 to 5 of the procedure for filling the vaporizer see above but keep the bottle below the filler 3 Raise the the filler control 2 and allow the liquid to run into the bottle until the flow ceases 4 Close the filler control 2 loosen the clamp screw 3 and reinsert the plug 4 Tighten the clamp screw 3 WARNING Anaesthetic drugs must be treat ed as a pharmaceutical product Liquid should never be drained from a vaporizer into an open container and reused Contamination is likely Always dispose of such drained liquid as a hazardous chemical FILLING AND DRAINING 5 2 Screw Cap Filling System Pour Fill CAUTION To minimise atmospheric pollution in the operating room fill the vapor izer in a fume cupboard or under an extractor hood WARNING The vaporizer must be either secured to the anaesthetic machine or free standing on a level table so that in either case it is upright during the filling process Overfilling may occur if the vaporizer is tipped during the filling process WARNING The vaporizer control must be in the 0 zero position during the filling process Provided this is done gas may continue to be delivered from the anaesth
27. etic machine during the filling process WARNING Check the drug name on the vaporizer and the supply bottle before commencing the filling process Filling the Vaporizer If the vaporizer is empty check that the control screw 1 is fully tightened before filling 1 Check that the vaporiz er concentration control 2 is in the O zero position as illustrated 2 Unscrew the filler cap 3 3 Remove the bottle cap and fill the vaporizer slowly and carefully stopping to check the liquid level occasionally Stop filling when the upper mark is reached on the filler block WARNING DO NOT OVERFILL A vaporizer that has been over filled must be withdrawn from use 4 Replace the filler cap after a visual check that the seal is in position on the cap Tighten finger tight only DO NOT use a wrench WARNING Do not operate the vaporizer if the filler cap is not secured in position Incorrect concentration may be delivered to the patient and pol lution may result FILLING AND DRAINING Draining the Vaporizer CAUTION To minimise atmospheric pollution in the operating room perform vaporizer drainage in a fume cup board or under an extractor hood WARNING The vaporizer must be either secured to the anaesthetic machine or free standing on a level table so that in either case it is upright during the draining process WARNING The vaporizer concentration control must be in the 0
28. gen will produce a decrease in output below the scale value At a con centration of 70 nitrous oxide out put may decrease by up to 15 Carbon dioxide Carbon dioxide is not usually added in high concentrations and is usually limited to 5 At this con centration the effect on vaporizer output is negligible Air Air will reduce the output of the vaporizer below the scale values by a maximum of 5 Helium Vaporizers will give low results on helium enriched mixtures and the use of an analyser is recommend ed if accurate concentrations are required when using this gas PERFORMANCE CHARACTERISTICS 7 7 Output when Control is at 0 zero Output vapour concentration when the control is at 0 zero is less than 0 03 vol when tested in accor dance with ASTM 1161 88 7 8 Effect of Flush Valve Operation Operating the flush valve on the anaesthetic machine will affect out put concentration by less than 20 Note that the vaporizer was tested to ISO 8835 1 IEC 60601 2 13 36 8 CAUTION Do not attempt to dismantle the vaporizer or make any adjustment to it which is outside the scope of the following instructions 8 1 Servicing NOTE A label is fixed across the vaporiz er body and top cover bearing the words GENUINE PART LABEL TAMPERING VOIDS WARRANTY When the bottom cover of the vaporizer is removed this label will be damaged beyond repair as per manent evidence of unauthorised se
29. gent specific filler models check that the filler plug is fully inserted and that the clamp screw is fully tightened 4 On pour fill screw cap filler models check that the filler cap is securely closed 5 Perform a back bar mani fold leak test as detailed in the relevant anaesthetic machine user instruction manual WARNING Anaesthetic machine designs are constantly evolving and new models may differ dimensionally from existing equipment It is the user s responsibility to ensure that the configuration of the anaesthetic machine allows correct installation of the vaporizer 27 7 PERFORMANCE CHARACTERISTICS NOTE Concentration output figures quoted and shown graphically in this section were compiled from average test results from a number of vaporizers The output from individual units may vary from these average figures 28 Output Vol Output Vol PERFORMANCE CHARACTERISTICS 7 1 Performance Graphs 7 1 1 Halothane Variation of output with flow rate Temperature 20 C 5 neenemeee 5 Set Ls AY set 3 ee 2O SEL 1 1 set 0 6 set 0 0 2 set 0 2 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 Flow rate L min Variation of output with temperature Flow rate 5 L min 6 5 5 set 4 4 set 3 2 2 set 1 1 set 0 6 set 0 0 2 set 10 15 20 25 30 35 Temperature C 29 Output Vol Output Vol PERFORMANCE CHARACTERISTICS 7 1 2 Enflurane Models Variation of o
30. let of the vaporizer It is recommended that detachable cagemount connectors are retained with Safety Clip Part Number 52275 to prevent inadvertent disconnection WARNING Test the joints for gas tightness before using the machine INSTALLATION 6 5 Drager Plug in Compatible interlock Installation NOTE When installing two vaporizers only on a three station manifold the centre station must be occupied by one of the vaporizers 1 Carefully offer the vaporizer up to the manifold 2 Align the gas connection ports with the valve capsule on the manifold The capsule is referred to as the valve cartridge in some user literature 3 Carefully lower the vaporizer onto the manifold and recheck that the gas ports are correctly engaged with the valve capsule cartridges on the manifold 4 Lock into position by pushing the locking lever 1 downwards and rotating clockwise through approximately 1009 Pre use Checks Observe the WARNINGS below and carry out the check list procedure given in section 6 7 WARNING To prevent damage to the locking shaft 3 and to ensure that the gas connection ports are correctly engaged check 25 1 Locking Lever 2 Interlock Bolts 3 Back Bar Manifold Locking Shaft that the vaporizer is firmly positioned on the manifold before tightening the locking lever The locking lever MUST be in the locked position before the vaporizer is used Removing
31. luding any additional work Signature 47 SERVICE RECORDS Date Comments including any additional work Signature SERVICE RECORDS Date Comments including any additional work Signature 49 SERVICE RECORDS Year One Ts Pr Cee Signature Print name Leak Test at 200 mmHg for minimum 60 secs Pressure must not drop below 180 mm Hg 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 aUmin Comments 50 SERVICE RECORDS Year Two TP eT Signature Print name Leak Test at 200 mmHg for minimum 60 secs Pressure must not drop below 180 mm Hg 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 amin Comments 51 SERVICE RECORDS Year Three TP eT Signature Print name Leak Test at 200 mmHg for minimum 60 secs Pressure must not drop below 180 mm Hg Tolerance 0 0 0 0 1 0 2 0 14 0 26 0 6 0
32. meared with an oxy gen compatible lubricant such as Fomblin 3 Engage the taper joints by applying axial pressure 4 Tighten the fixing nuts 3 23 INSTALLATION Installation on Modura Rail WARNING The vaporizer must not be tipped or inverted during installation If the vaporizer has been tipped or inverted it must be set to maximum and flushed at 5 L min for ten minutes Check for stable output before clinical use 1 Remove the M6 nuts and washers the clamp plate and the shims from the vaporizer 2 Fit the Modura claw 1 to the backplate 2 using the two M6 screws 3 Fit the Modura claw backplate assembly to the studs 3 on the rear of the vaporizer and secure with the M6 nuts and washers 24 4 Attach the vaporizer to the Modura rail on the anaesthetic machine and secure in place by moving the lever into its locked on position Pre use Check Observe the WARNING below and carry out the check list procedure given in section 6 7 WARNING Test the joints for gas tightness before using the machine 6 4 Penlon Off line Mounting System A vaporizer with cagemount tapers may be fitted with a Penlon clip Part No 58090 in place of the back bar clamp The vaporizer may then be fitted to a Penlon off line block use Penlon Part No 52280 for the Mk 2 and Part No 52270 for the Mk 3 system The flexible hoses attached to the block are connected to the inlet and out
33. nlon Limited reserves the right to make any changes which may affect instructions in this manual without giving prior notice Personnel must make themselves familiar with the contents of this manual before using the vaporizer Terminology This manual complies with ISO 4135 Anaesthetic Apparatus Terminology The following additional definitions should be noted Vol shortened form of volumetric percentage The commonly used method of expressing vapour concentrations so that they can be compared with concentrations of true gases 100 Vol is equivalent to 100 partial pressure in a mixture Copyright Penlon Ltd 2002 All rights reserved CONTENTS l 3 1 3 2 4 1 4 2 4 3 4 4 4 5 4 6 4 7 4 8 4 9 5 1 5 2 5 3 6 1 6 2 6 3 6 4 6 5 6 6 6 7 7 1 7 1 1 7 1 2 7 1 3 7 1 4 7 2 USER RESPONSIBILITY WARNINGS AND CAUTIONS PURPOSE DESCRIPTION Operating Principles Controls SPECIFICATION Physical Dimensions Weight Capacity Filling System Concentration Control Dial Scale Patents Temperature Range Flow Range Pressure Range FILLING AND DRAINING Key Filler System Screw Cap Pour Fill System Quik Fil Filling System INSTALLATION Gas Port Transit Seals Selectatec Compatible Models with interlock Cagemount 23 mm Taper Models Penlon Off line System Mk 2 and Mk 3 Drager Plug in Compatible North American Drager Compatible Pre Use Checklist All Models PERFORMANCE
34. ock The vaporizer contains a chamber the base of which holds the anaes thetic agent in liquid form A wick ensures that the upper part of the chamber is filled with the saturated vapour of the agent The wick has a patented construction The concentration of saturated vapour is many times higher than those used clinically and the func tion of the concentration control is to proportion the flow of the carrier gas through a bypass passage and through the vapour chamber so that the desired dilution is pro duced In the zero position the bypass remains open but the vaporizing chamber is shut off completely from the gas flow to the patient A temperature compensating valve is situated in the bypass arranged to operate so that as the vapour pressure varies with temperature the dilution ratio produced by the control valve is varied to compen sate and maintain a constant out put concentration The vaporizer has a liquid level indicator with maximum and mini mum level marks 1 Liquid level indicator 2 Control dial 0 zero position 3 Interlock bolt 3 2 Controls The vaporizer has a single forward facing calibrated control to regulate the vapour concentration delivered The dial is locked at zero when not in use To set a concentration level push the dial assembly in and rotate anti clockwise Align the required concentration graduation with the mark at the top of the bezel On returning the dial to z
35. ontract UK only by a Penlon certified engineer by a suitably qualified hospital technician if agent analysis apparatus is available To be comparable with the master calibration such tests must conform to the following a b The carrier gas should be oxygen The vaporizer must be filled and fixed upright and stationary at a temperature between 18 and 22 C 64 and 72 F for at least 2 hours USER MAINTENANCE c A mixing chamber must be attached to the outlet of the vaporizer to ensure that a homogenous mixture is sampled This is particularly necessary at low gas flow rates The sampling system must be of non absorbent material such as nylon Rubber etc absorbs vapour to a_ substantial extent Flow rates etc must lie within the range covered by the master calibration charts The analysis apparatus must be of an approved type eg a Riken refractometer However if the calibration check is undertaken by a hospital technician it is permissible to use a commercially available agent analyser but only if i the analyser is calibrated to the manufacturers specification and schedule ii output failures are confirmed by a Penlon certified engineer using a refractometer Output values should be recorded in section 11 The vaporizer serial number and any comments must be written at the foot of each page 39 8 5 Training Courses A training course is available to
36. r s responsibility to ensure that the configuration of the anaesthetic machine allows correct installation of the vaporizer There must be sufficient clearance between the 23 selectatec manifold and the rear frame panelling of the machine to allow the vaporizer connector block to seal correctly on the manifold Before use test all joints for gas tightness and perform back bar function tests as detailed in the anaesthetic machine user manual Using the vaporizer 24 25 Check the liquid level frequently when using the vaporizer and maintain the level between the min and max marks The vaporizer control must be in the zero 0 position during the filling process see warning 7 Vaporizer outputs are sensitive to barometric pressure A correction factor may be necessary when assessing the output using an analyser for example at high altitude Barometric pressure effects are not usually of clinical importance see section 7 3 WARNINGS AND CAUTIONS 26 27 28 29 30 The vaporizer is a flow direction sensitive apparatus and the direction of gas flow towards the patient must be as indicated by the arrow on the top label Reversal of flow may cause inaccuracies of delivered concentration The vaporizer must not be used downstream of the common gas outlet As stated in section 2 the vaporizer is of relatively high resistance and must not be incorporated within a br
37. remove the bottle and refit the filler block cap before using the vaporizer Delivered concentrations are inaccurate while the filler port is open Before using the vaporizer 18 19 Do not use the vaporizer if the agent level is not visible in the sight glass or the level is outside of the Max Min indicator f a vaporizer is transported when filled with liquid drug the control must be in the 0 zero position during transport and a period of at least ten minutes in a secured upright position must elapse before connection to an anaesthetic breathing system Movement during transport can result in over dosage unless time is allowed for drainage of liquid to the normal WARNINGS AND CAUTIONS 20 21 22 position If a vaporizer has been transported with the control in the open position it must be flushed at 5 L min for ten minutes before clinical use on a patient The vaporizer must not be tipped over or inverted If the vaporizer has been tipped over or inverted it must be set to maximum output and flushed at 5 L min for ten minutes before clinical use on a patient The vaporizer must be securely fixed and in an upright position before connection to a patient There is a danger of overdosage if sudden inadvertent movement occurs during use Anaesthetic machine designs are constantly evolving and new models may differ dimensionally from existing equipment It is the use
38. rom the anaesthetic machine to a patient during the filling process WARNING Check that the drug name on the vaporizer and the supply bottle are the same before commenc ing the filling process and ensure that the bottle is fitted with a keyed collar Filling the Vaporizer This system is manufactured in compliance with ISO 5360 1 Check that the vaporizer concentration control 1 is in the O zero position as illustrated 2 Attach the keyed filler adap tor 2 to the bottle 3 12 FILLING AND DRAINING NOTE Penlon supply a complete range of agent specific filler adaptors see section 10 3 Tighten the adaptor to ensure an airtight joint which must be maintained throughout the filling opera tion WARNING Failure to observe this instruc tion may result in overfilling FILLING AND DRAINING 4 Loosen the clamp screw 4 Remove the plug 5 5 Insert the keyed end of the bottle adaptor 2 fully into the vaporizer receiver Only the correct keyed adaptor can enter the receiver Tighten the clamp screw 4 to secure the adaptor 6 Raise the bottle above the filler see arrow on the illustration 7 Open the filler control 6 lift upwards Allow the liquid to flow into the vaporizer until the upper mark is reached on the filler block 7 WARNING DO NOT OVERFILL A vaporizer that has been overfilled must be withdrawn from use If the vaporizer has been inadvertently overfilled
39. rvicing repair or modification If this label or other labels is miss ing do not use the vaporizer until it has been serviced see below The Sigma Delta must only be serviced at an authorised service centre or by Penlon trained techni cians in accordance with the fol lowing procedure The calibration should be checked periodically under controlled conditions section a 8 4 and leak tests per formed Record the measured values in section 11 37 USER MAINTENANCE b Successive sets of figures should be compared to deter mine if performance is deteri orating Should deterio ration be detected a service should be carried out to restore normal operation A major overhaul must be performed every ten years Halothane models 5 years to maintain performance within the specification The Selectatec compatible vaporizer locking system should be inspected during the vaporizer calibration test and if damage to the locking shaft is suspected the device must be referred to a Penlon certified engineer Interlock system vaporizers function test the interlock sys tem during the vaporizer cali bration test Quik Fil system at regular intervals 3 monthly mini mum 6 monthly maximum filling and draining must be checked under controlled conditions NOTE The user must accept responsibili ty for any malfunction which results from non compliance with the above requirements USER MAINTENANCE
40. stance ataUmin Comments 57 SERVICE RECORDS Year Nine Ts Pe eT Signature Print name Leak Test at 200 mmHg for minimum 60 secs Pressure must not drop below 180 mm Hg 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 amin Comments 58 SERVICE RECORDS Year Ten Ts Pe eT Signature Print name Leak Test at 200 mmHg for minimum 60 secs Pressure must not drop below 180 mm Hg 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 ataUmin Comments 59 60 C 0473 Cat No 52606 Doc No D0102UI February 2002 Penlon Limited Radley Road Abingdon OX14 3PH UK Service Tel 44 0 1235 547063 Fax 44 0 1235 547062 E mail service penlon co uk International Sales Tel 44 1235 547001 Fax 44 1235 547021 E mail export penlon co uk UK Sales Tel 01235 547036 Fax 01235 547023
41. stance valve in the bypass pas sage The design provides com pensation for the full range of user temperatures If the vaporizer is used in extreme temperatures outside those shown in section 4 7 outputs may be lower or high er than indicated by the concentra tion control NOTE The temperature compensator reacts relatively slowly to room temperature changes If the temperature around the vaporizer is suddenly changed e g by wheeling an anaesthetic machine from a cool store into the atre 1 to 2 hours minimum should be allowed for it to equalise with the ambient temperature before use 7 3 Pressure Effects 7 3 1 Ambient Pressure Ambient pressure effects are not normally of clinical significance but the following rules apply The control is graduated in units of vol at 101 3 kPa 14 7 psi At any other pressure the true output will be modified according to the equation C S x 101 3 P P is absolute pressure in kPa 33 C is delivered concentration vol S is the set value Changes in barometric pressure can be ignored clinically because they affect the vaporization in the vaporizer and the absorption of vapour through the lungs in the some way They must be corrected for when checking outputs with an analyser NOTE Some analysers include automatic barometric pressure correction Check the instructions provided with the analyser 7 3 2 Back Pressure Back pressures imposed on the vaporizer by
42. t at 200 mmHg for minimum 60 secs Pressure must not drop below 180 mm Hg 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 ataUmin Comments 55 SERVICE RECORDS Year Seven Ts Pe eT Signature Print name Leak Test at 200 mmHg for minimum 60 secs Pressure must not drop below 180 mm Hg 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 amin Comments 56 SERVICE RECORDS Year Eight Ts Pt eT Signature Print name Leak Test at 200 mmHg for minimum 60 secs Pressure must not drop below 180 mm Hg 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 resi
43. uitable agent analyser e g a Riken refractometer or infrared analyser b The service check is part of the recommended pre use check for your Anaesthesia System Should the calibration check show the unit to be outside the specified performance requirement see section 11 then a service must be performed 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 record section is provided to maintain a record of the vaporizer s performance For any enquiry regarding the service or repair of this vaporizer contact the nearest accredited Penlon agent or contact the Service Department at Penlon Limited Agent s name and address Service and Repair Department Penlon Ltd Abingdon OX14 3PH UK Tel 44 0 1235 547063 Fax 44 0 1235 547062 E mail service penlon co uk Always give as much of the following information as possible 1 Type of equipment 2 Product name 3 Serial number 4 Approximate date of purchase 5 Apparent fault FOREWORD This manual has been produced to provide authorised personnel with information on the function routine performance and maintenance checks applicable to the Penlon Sigma Delta vaporizer Information contained in the manual is correct at the date of publication The policy of Penlon Limited is one of continued improvement to its products Because of this policy Pe
44. utput with flow rate Temperature 20 C _ eee cee 4 set __ 80 set 1 set 0 6 set 0 2 set 021 2 3 4 5 6 7 8 9 10 11 12 13 14 15 Flow rate L min Variation of output with temperature Flow rate 5 L min 6 5 5 set 4 4 set 3 2 2 set 1 1 set 0 6 set 0 0 2 set 10 15 20 25 30 35 Temperature C 30 Output Vol Output Vol PERFORMANCE CHARACTERISTICS 7 1 3 Isoflurane Models Variation of output with flow rate Temperature 20 C A E 5 set a E OE 2 set 1 set 0 6 set 0 2 set 021 2 3 4 5 6 7 8 9 10 11 12 13 14 15 N wo A A Q mak Flow rate L min Variation of output with temperature Flow rate 5 L min 5 set 4 set 2 set 1 set 0 6 set 0 2 set 10 15 20 25 30 35 Temperature C 31 Output Vol Output Vol PERFORMANCE CHARACTERISTICS 7 1 4 Sevoflurane Models O N OO A ADDN OD 10 Variation of output with flow rate Temperature 20 C 6 7 8 9 10 11 Flow rate L min 8 set 7 set 6 set 5 set 4 set 3 set 2 set 1 set 0 6 set 0 2 set 12 13 14 15 Variation of output with temperature Flow rate 5 L min 19 20 5 Temperature C 32 30 8 set 6 set 5 set 4 set 2 set 1 set 0 6 set 0 2 set 35 PERFORMANCE CHARACTERISTICS 7 2 Temperature Compensation Temperature compensation is pro vided by the operation of a variable resi
45. ystem valve This may cause a vapour and fresh gas leak The filler system must be maintained in accordance with the instructions given 18 in the User Maintenance section The vaporizer must be filled only by suitably skilled and trained person nel After filling remove the bottle and refit the filler block cap before using the vaporizer Do not use the vaporizer if the agent level is not visi ble in the sight glass or the level is outside of the Max Min indicators FILLING AND DRAINING Quik Fil System Filling the Vaporizer 1 Check that the vaporizer concentration control is in the off 0 position 2 Remove the yellow protective cap from the anaesthetic agent bottle filler checking that the bottle and filler mechanism are not damaged 3 Remove the vaporizer filler block cap and insert the bottle nozzle into the filler block Rotate the bottle to align the bottle filler keys with the slots in the filler block 4 Note the liquid level in the vaporizer sight glass and press the agent bottle firmly into the vaporizer filler against the spring valve assembly Allow the liquid to flow into the vaporizer until the maximum level mark is reached paying continuous attention to the level in the sight glass and the air return bubbles flowing into the bottle 5 Release the bottle when the vaporizer is full and the continuous stream of bubbles ceases 6 Withdraw the bottle from the vaporiz
Download Pdf Manuals
Related Search