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8-1

User Maintenance

8.1 Repair Policy

WARNING

Do not modify or disassemble the vaporizer. Any change of the vaporizer may cause

incorrect output concentration.

Stop using the vaporizer immediately if it has been found to need repair. Contact trained service
personnel for repair. After repair, test the vaporizer to ensure that it is functioning properly, in
accordance with the specifications.

NOTE

All repairs must be carried out by qualified service personnel.

Replace damaged parts with components manufactured or sold by Mindray. After

repair, test the unit to make sure that it complies with the manufacturer’s published

specifications.

Contact Mindray for service assistance.

Summary of Contents for V60

Page 1: ...V60 Anesthetic Vaporizer Operator s Manual ...

Page 2: ......

Page 4: ...al information Disclosure of the information in this manual in any manner whatsoever without the written permission of Mindray is strictly forbidden Release amendment reproduction distribution rental adaptation translation or any other derivative work of this manual in any manner whatsoever without the written permission of Mindray is strictly forbidden and are the trademarks registered or otherwi...

Page 5: ...this product only if all installation operations expansions changes modifications and repairs of this product are conducted by Mindray authorized personnel the electrical installation of the relevant room complies with the applicable national and local requirements and the product is used in accordance with the instructions for use WARNING z This Anesthetic Vaporizer must be operated by skilled tr...

Page 6: ...made failure Malfunction or damage caused by unstable or out of range power input Malfunction or damage caused by major forces such as fire and earthquake Malfunction or damage caused by improper operation or repair by unqualified orunauthorized service people Malfunction of the instrument or part whose serial number is not legible enough Others not caused by instrument or part itself Customer Ser...

Page 7: ...3 1 3 2 1 Plug in Adapter Plug in Connector 3 2 3 2 2 Interlock Device 3 4 3 3 Filling System 3 5 4 Filling and Draining 4 1 4 1 Checks before Filling 4 1 4 2 Filling the Vaporizer 4 1 4 2 1 Pour Fill System 4 3 4 2 2 Key Filler System 4 6 4 2 3 Quik Fil System 4 11 4 3 Draining the Vaporizer 4 13 4 3 1 Pour Fill System 4 13 4 3 2 Key Filler System 4 16 4 3 3 Quik Fil System 4 19 4 4 Blowing off t...

Page 8: ... Remedies 9 3 9 3 Plug in Adapter Related Faults and Remedies 9 3 10 Storage and Transport 10 1 10 1 Storage 10 1 10 2 Transport 10 2 11 Theory of Operation 11 1 11 1 Operating Principle 11 1 11 2 Calibration 11 3 11 3 Influence of Temperature 11 3 11 4 Influence of Flow 11 6 11 5 Influence of Gas Composition 11 8 11 6 Influence of Atmospheric Pressure 11 9 11 7 Influence of Fluctuations in Pressu...

Page 9: ...3 C Symbols and Terminology C 1 C 1 Symbols C 1 C 2 Terminology C 1 ...

Page 10: ...4 FOR YOUR NOTES ...

Page 11: ...ot avoided could result in death or serious injury CAUTION z Indicates a potential hazard or unsafe practice that if not avoided could result in minor personal injury or product property damage NOTE z Provides application tips or other useful information to ensure that you get the most from your product ...

Page 12: ...only specified non combustible anesthetic agent in compliance with the requirement of ISO80601 2 13 z Any unauthorized organization or untrained person must not change or disassemble the Anesthetic Vaporizer z This Anesthetic Vaporizer may not be modified without the manufacturer s permission z The medical device must be inspected and serviced regularly by service personnel z Before use check that...

Page 13: ...ble if the unit is tilted beyond 10 degrees z Always install or carry the Anesthetic Vaporizer properly to avoid damage caused by drop impact strong vibration or other mechanical force Do not carry by the control dial or the handle for locking lever 1 1 3 Notes NOTE z Keep this manual close to the Anesthetic Vaporizer so that it can be obtained conveniently when needed z This manual describes all ...

Page 14: ...tion MR Unsafe do not subject to magnatuc resonance imaging MRI EAC Unified circulation mark indicates that products marked them passed all specified in the technical regulations of the Customs Union of the procedure for the assessment confirmation of conformity and complies with the requirements applicable to all the products technical regulations of the Customs Union ...

Page 15: ...izer is not influenced by ambient conditions such as temperature gas flow and ventilation pressure The Anesthetic Vaporizer is not suitable for use with an anesthetic delivery system with vaporizer placed inside the circuit system due to relatively high internal pneumatic resistance The vaporizer delivery system is in compliance with ISO80601 2 13 The Key Filler system is in compliance with ISO536...

Page 16: ... z The Anesthetic Vaporizer is intended to be operated only by licensed clinicians and qualified anesthesia personnel who have received adequate training in its use Anyone unauthorized or untrained must not perform any operation on the Anesthetic Vaporizer z This Anesthetic Vaporizer is not suitable for use in an MRI environment 2 3 Anesthetic Vaporizer Appearance 2 3 1 Front View 1 0 button 2 Con...

Page 17: ...2 3 2 3 2 Rear View 1 Handle for locking lever 2 Interlock system 3 Locking pin ...

Page 18: ...ane Quik Fil system Sevoflurane Quik Fil filling adapter Sevoflurane Quik Fil drainage funnel Sevoflurane Pour Fill Vaporizer Sevoflurane Pour Fill system Enflurane Key Filler Vaporizer Enflurane Key Filler system Enflurane Pour Fill Vaporizer Enflurane Pour Fill system Enflurane Key Filler filling adapter Halothane Key Filler Vaporizer Halothane Key Filler system Halothane Pour Fill Vaporizer Hal...

Page 19: ...fore turning the control dial If the vapour is stored in high temperature and then used the concentration of the delivered anesthetic agent may be high To enable pressure equalization always turn the control dial to 1 after connecting the anesthetic workstation and wait for at least 15 seconds 3 2 Connecting and Interlock System When the anesthetic delivery system is connected to multiple vaporize...

Page 20: ...tic delivery systems with plug in connectors with an Ohmeda Selectatec compatible manifold system The holes in the plug in adapter on the vaporizer fit onto the pins on the plug in connector on the anesthetic delivery system Interlock device Plug in adapter and pin Plug in connector ...

Page 21: ...l must be at the 0 setting indicating locked status Press the handle for locking lever and turn the handle clockwise for 90 to lock the vaporizer and counter clockwise for 90 to release locking Initial position Locked position Control dial at the 0 setting ...

Page 22: ...vice is fully functional z A malfunction in the interlock system can endanger the patient by overdosing or mixing anesthetic agents NOTE z To ensure the normal operation of the vaporizer connect the vaporizer in the correct flow direction corresponding with the arrows on the Anesthetic Vaporizer z When the anesthetic delivery system has three and more than three groups of plug in connectors check ...

Page 23: ...ystem has a liquid level indicator which displays filling level with the maximum and minimum levels marked Pour Fill system Key Filler system Filler control Keyed block Lock knob Maximum mark Minimum mark Connector for non specific filling system Filler cap Maximum mark Minimum mark Drainage knob Drainage outlet ...

Page 24: ...3 6 Quik Fil system Quik Fil specific filling system Drainage knob Filler cap Maximum mark Minimum mark Drainage outlet ...

Page 25: ...the first time wait 15 minutes for the dry wicks inside to become saturated The filling level of the anesthetic agent may drop Refill if required 4 2 Filling the Vaporizer CAUTION z Take care not to spill anesthetic agent Inhaling anesthetic agent vapor endangers health NOTE z The Anesthetic Vaporizer may only be used on the anesthetic delivery system after the operating organization has checked a...

Page 26: ...omposition and physical and chemical properties and are approved as medicaments can be administered in combination in the vaporizer and monitored with anesthetic agent monitor WARNING z Stop using a vaporizer immediately which has been filled or partly filled with the wrong anesthetic agent or other substance to prevent danger to health If this occurs mark the vaporizer for incorrect filling and c...

Page 27: ...daptor from the vaporizer and the bottle adaptor from the bottle small amounts of anesthetic agent will escape to the environment 4 2 1 Pour Fill System The filling steps of V60 Isoflurane Pour Fill Vaporizer and V60 Sevoflurane Pour Fill Vaporizer are the same If the vaporizer is connected to the anesthetic delivery system fresh gas flow can remain as set 1 Turn the control dial clockwise back to...

Page 28: ...aporizer 2 Unscrew the filler cap slowly so that any pressure in the vaporizer can escape slowly 3 Check if the names of anesthetic agent and color mark on the vaporizer and the anesthetic agent bottle correspond If the correct agent is being used unscrew the cap from the anesthetic agent bottle Pour anesthetic agent slowly into the filler receiver CAUTION z Take care not to spill anesthetic agent...

Page 29: ...l the level drops below the maximum mark 5 When the maximum mark is reached stop pouring agent If the vaporizer is filled above the maximum mark by a few millimeters the anesthetic agent will start to overflow through the overflow hole CAUTION z When the anesthetic vaporizer is overflowed the anesthetic agent will escape to the environment 6 Tighten the filler cap clockwise If this is not done pro...

Page 30: ... are not done properly 4 2 2 Key Filler System The filling steps of V60 Isoflurane Key Filler Vaporizer and V60 Sevoflurane Pour Fill Vaporizer are the same If the vaporizer is connected to the anesthetic delivery system fresh gas flow can remain as set 1 Turn the control dial clockwise back to 0 position until the 0 button pops up WARNING z Significant quantities of anesthetic agent vapor may esc...

Page 31: ...ames symbols of anesthetic agent on the filling adapter anesthetic agent bottle and vaporizer must correspond to the anesthetic agent used WARNING z Do not use a damaged filling adapter or an anesthetic agent bottle without collar If a bottle without collar is used specific filling adapter cannot be identified underlying the risk of filling a wrong anesthetic agent CAUTION z If the connection betw...

Page 32: ...4 8 3 Turn the lock knob counter clockwise 4 Remove the keyed block 5 Push the keyed end of the filling adapter into the opening of the filling system until it cannot move ...

Page 33: ...Tighten the lock knob clockwise CAUTION z If the connection between the filling adapter and filling system is not leak tight anesthetic agent may escape 7 Raise the anesthetic agent bottle upside down slowly ...

Page 34: ... flow into the vaporizer 10 Close the filler control 11 Put down the anesthetic agent bottle slowly 12 Unscrew the lock knob 13 Pull the keyed end of the filling adapter out of the filling system 14 Put the keyed block back into the opening of the filling system 15 Tighten the lock knob 16 Unscrew the filling adapter 17 Tighten the cap of the anesthetic agent bottle even if it is completely empty ...

Page 35: ...re to balance and prevents fresh gas and anesthetic agent vapor froming escaping from the vaporizer 2 Select the correct filling adapter and anesthetic agent bottle Remove cap from the anesthetic agent bottle checking that the bottle and filler mechanism are not damaged Screw the Quik Fil adapter firmly into the anesthetic agent bottle 3 Remove the cap from the anesthetic agent bottle checking tha...

Page 36: ... to flow into the vaporizer CAUTION z If the connection between the filling adapter and anesthetic agent bottle is not leak tight anesthetic agent may escape 7 Check the filling level in sight glass during filling When the maximum mark is reached stop pressing the bottle And pull out the bottle slowly If the vaporizer is filled above the maximum mark by a few millimeters the anesthetic agent will ...

Page 37: ...t which has been drained off must be handled stored or disposed of as medicament If this is not done there will be a risk of administering incorrect anesthetic agents 4 3 1 Pour Fill System The draining steps of V60 Isoflurane Pour Fill Vaporizer and V60 Sevoflurane Pour Fill Vaporizer are the same CAUTION z Take care not to spill anesthetic agent Do not inhale anesthetic agent vapor which endange...

Page 38: ... agent can drain out 1 Turn the control dial clockwise back to 0 position until the 0 button pops up 2 Hold the correct bottle for the anesthetic agent being drained below the drainage outlet at the bottom of the vaporizer 3 Unscrew the filler cap counter clockwise slowly ...

Page 39: ...hetic agent has to be removed from the wick see 4 4 Blowing off the Vaporizer NOTE z Do not fill the bottle to the very top This can lead to escape of anesthetic agent 5 When the vaporizer has been completely drained close the drainage knob clockwise 6 Tighten the cap of the anesthetic agent bottle even if it is completely empty 7 Tighten the filler cap WARNING z Tighten the filler cap and drainag...

Page 40: ...ion until the 0 button pops up 2 Select the correct anesthetic agent bottle and open the bottle Do not use a damaged filling adapter or anesthetic agent bottle 3 Select the correct filling adapter for the anesthetic agent 4 Screw the filling adapter firmly into the anesthetic agent bottle 5 Turn the lock knob counter clockwise CAUTION z If the connection between the filling adapter and anesthetic ...

Page 41: ...yed end of the filling adapter into the opening of the filling system until it cannot move 8 Tighten the lock knob clockwise CAUTION z If the connection between the filling adapter and filling system is not leak tight anesthetic agent may escape ...

Page 42: ... out of the filling system 13 Put the keyed block back into the opening of the filling system 14 Tighten the lock knob 15 Unscrew the filling adapter 16 Tighten the cap of the anesthetic agent bottle even if it is completely empty WARNING z Close the filler control and tighten the lock knob after draining the vaporizer is completed Failure to do so may cause anesthetic agent to escape NOTE z Anest...

Page 43: ...k Fil adapter firmly into the anesthetic agent bottle Insert the drainage funnel Depress the drainage funnel and rotate the bottle simultaneously until it cannot move CAUTION z If the connection between the filling adapter and anesthetic agent bottle is not leak tight anesthetic agent may escape endangering health 3 Insert the bottle equipped with Quik Fil drainage funnel into the slot at the bott...

Page 44: ...lose the drainage knob clockwise 7 Tighten the filler cap 8 If the anesthetic agent has also to be removed from the wick see 4 4 Blowing off the Vaporizer WARNING z Tighten the filler cap and drainage knob after draining the vaporizer is completed Failure to do so may cause anesthetic agent to escape when the vaporizer is switched on next time 9 Unscrew the drainage funnel and adapter from the bot...

Page 45: ...thetic delivery system in accordance with Instructions for Use and connect the waste gas scavenging system Switch on the anesthetic agent monitor Set the correct anesthetic agent and alarm limits Switch on the oxygen and CO2 monitor and set the alarm limits WARNING z The Anesthetic Vaporizer may become unstable if the unit is tilted beyond 10 degrees z If a vaporizer is operated at an angle of mor...

Page 46: ... Pour Fill Quik Fil Put the filler cap in place and tighten it securely Tighten the drainage knob securely Key Filler Close the filler control and tighten the lock knob securely 3 Connector system Plug in connector on anesthesia machine Press the plug in adapter level on the seals Handle for locking lever Swing the handle for locking lever counter clockwise Check if the vaporizer is secure and is ...

Page 47: ...h other z Check as per the above items If these are not done an incorrect concentration may be displayed z Interlock device malfunction may cause several vaporizers to be switched on simultaneously which endangers the patient by resulting in overdosing or a mixture of anesthetic agents 6 Check that the vaporizer connector and fresh gas circuit are leak tight see Instructions for Use for Anesthetic...

Page 48: ...5 4 FOR YOUR NOTES ...

Page 49: ...rely onto the manifold z Only use Anesthetic Vaporizer with anesthetic delivery systems that are suitable according to ISO80601 2 13 z If the Anesthetic Vaporizer is connected to anesthetic delivery systems from other manufacturers it is the responsibility of the operator to ensure that all technical specifications of the Anesthetic Vaporizer and the anesthetic delivery systems are met 6 1 Connect...

Page 50: ...Switch the vaporizers off when one or more than one vaporizers have been on the manifold of the anesthetic delivery system before hanging on another vaporizer 4 Set the control dial to 0 position 5 Hold the vaporizer in vertical position with both hands and lower gently onto the anesthesia machine plug in connector The sealing rings are undamaged ...

Page 51: ...cured and cannot be removed 7 Connect two or more than two vaporizers on the anesthetic delivery system If the anesthetic delivery system has two groups of plug in connectors the interlock pins of the two connected vaporizers must be contact directly Locking lever in locked position Direct contact ...

Page 52: ...ee 6 4 Disconnecting the Vaporizer and check the positions of locking lever and vaporizer manifold of the anesthetic delivery system Then re connect the vaporizer 6 2 Adjusting the Concentration of Anesthetic Agent WARNING z Before operation check that the control dial turns normally z Do not use the vaporizer tilted for an angle of more than 30 fixed position Risk of incorrect output concentratio...

Page 53: ...alues check the vaporizer for incorrect filling and check the monitor for incorrect setting NOTE z During prolonged operation with both a high flow of fresh gas and a high concentration the concentration administered may decrease See 11 8 Influence of Running Time CAUTION z Jerky movements or tilting at an angle of more than 30 can cause incorrect output concentration z Equip with anesthetic gas s...

Page 54: ...issible temperature and humidity range 3 Observe use by date of the anesthetic agent 5 If the vaporizer has to be removed from the anesthetic delivery system see 6 4 Disconnecting the Vaporizer and 6 5 Moving when Filled 6 4 Disconnecting the Vaporizer CAUTION z Take care not to drop the vaporizer Do not use the vaporizer if it has been dropped Damage may cause incorrect output concentration Do no...

Page 55: ...ct output concentration 2 The anesthetic delivery system with securely fastened vaporizers can be moved with control dial set at 0 if there is no risk of tilting by more than 30 WARNING z When tilted at an angle of more than 30 The anesthetic agent may overflow when the control dial is set at 0 endangering health When the control dial is set above 0 the anesthetic agent may leak and get into the f...

Page 56: ...6 8 FOR YOUR NOTES ...

Page 57: ...zer housings 7 1 Cleaning 1 Clean the surface of the vaporizer housing with a damp cloth soaked in water or green soap tincture The pH value is 7 0 to 10 5 2 After cleaning the housing remove the remaining detergent by wiping with a dry lint free cloth WARNING z Do not immerse the Anesthetic Vaporizer or the filling adapter in detergents z The detergent must not be allowed to get under the control...

Page 58: ... isopropyl alcohol 2 of glutaraldehyde neutral Sodium hypochlorite solution 10 available chlorine Super Sani Cloth 0 5 Quaternary ammonium chloride and 55 Isopropyl alcohol WARNING z Do not sterilize the vaporizer and accessories Damage inside may cause incorrect output concentration ...

Page 59: ...act trained service personnel for repair After repair test the vaporizer to ensure that it is functioning properly in accordance with the specifications NOTE z All repairs must be carried out by qualified service personnel z Replace damaged parts with components manufactured or sold by Mindray After repair test the unit to make sure that it complies with the manufacturer s published specifications...

Page 60: ...anesthesia machine plug in connectors See section 8 5 Checking the Plug in Adapter The gas inlet and outlet are not soiled Semiyearly and after service All round checks of 8 User Maintenance should be performed by trained service personnel CAUTION z Do not pour water or any cleaning solutions into the vaporizer 8 3 Checking the Concentration Check the vaporizer output concentration weekly when con...

Page 61: ... 3 kPa 3 Determine the accuracy range Range of concentration accuracy maximum value always applies Operating environment 15 to 35 or 0 2 to 10 L min 10 to 15 or 35 to 40 or 10 to 15 L min Set concentration 6 0 20 vol or 20 rel whichever is greater 0 30 0 20 vol or 25 20 rel whichever is greater Set concentration 6 0 25 vol or 20 rel whichever is greater 0 35 0 25 vol or 30 20 rel whichever is grea...

Page 62: ...e opened and closed smoothly 4 The sight glass shows normal liquid level Quik Fil system 1 The sealing ring for filler cap is in good condition 2 The filling opening is clean 3 The valve core inside the filling opening can be depressed and retracts smoothly 4 The sight glass shows normal liquid level 8 5 Checking the Plug in Adapter Verify the following 1 When the Handle for locking lever is turne...

Page 63: ... plug in adapter safety locking device and sealing rings Have them repaired by trained service personnel if damage is found Valves in the anesthesia machine plug in connectors are damaged Repair by trained service personnel The vaporizer temperature is outside the specified application range such as filled with very cold anesthetic agent or operated with both flow and concentration high over a pro...

Page 64: ...onnel The 0 button is not pressed Press the 0 button The control dial is jammed Repair by trained service personnel The concentration can be adjusted without pressing the 0 button The 0 button is defective Repair by trained service personnel Anesthetic agent vapor has leaked during use The plug in adapter is not fitted flush Check the anesthesia machine plug in connector sealing rings and sealing ...

Page 65: ...rsonnel Anethetic agent does not flow into anesthetic vaporizer by Key Filler adapter The inner tube is blocked by liquid Close the filler control Unplug the keyed end of filling adapter from the opening of the filling system And then let the liquid in the inner tube draining into the bottle 9 3 Plug in Adapter Related Faults and Remedies Fault Cause Remedy The vaporizer cannot be disconnected The...

Page 66: ...9 4 FOR YOUR NOTES ...

Page 67: ...ions If storage temperature range is exceeded internal damage may occur which could cause incorrect output concentration Before putting into operation again carry out all round inspection first NOTE z When the anesthetic vaporizer is not in use for a long period of time use the plug to block the gas inlet and outlet z If the anesthetic vaporizer is stored in high temperature and then used the conc...

Page 68: ...ible If original packing is not available use strong packing with at least 5 cm of impact resistant material around each vaporizer Fasten packing securely WARNING z Do not transport the vaporizer with anesthetic agent filled or it may cause incorrect output concentration NOTE z Liquid anesthetic agents and filled vaporizers are subject to Hazardous Goods Regulations These regulations do not apply ...

Page 69: ...gas mixed with anesthetic gas The fresh gas is routed through valves J and K which are linked to the control dial A and through the vaporizing chamber G Fresh gas enters by the inlet D Some of the fresh gas is routed through the vaporizing chamber G and charged with anesthetic agent in soaked wick F The rest of the fresh gas is routed past the airway I and through the temperature compensator E ...

Page 70: ... based on heating or cooling the airway I This process compensates for the influence of temperature on the satuation concentration 2 The pressure compensating system H effectively reduces the pumping effect Control dial position at 0 Vaporizer switched off Fresh gas flows from the inlet D to the airway I and then passes the temperature compensator E and the cone valve B finally flows out from the ...

Page 71: ...on the vaporizer and in the Operator s Manual are given in the abbreviated form of vol which means vol at 101 3 kPa 11 3 Influence of Temperature The saturation concentration of the anesthetic agent rises as temperature rises The concentration deviation is automatically compensated by routing a higher proportion of the gas flow through the vaporizer bypass system The linear change of the bypass va...

Page 72: ... output concentrations are within the specified concentration accuracy If the temperature of the vaporizer before use is outside 10 to 40 a time of 15 min has to be allowed for temperature adjustment so that the concentration remains within the accuracy specified When the vaporizer is being operated with a high gas flow or a high concentration the anesthetic agent inside will cool down gradually w...

Page 73: ...11 5 0 1 2 3 4 5 6 10 15 20 25 30 35 40 Output concentration vol Temperature 5 4 3 2 1 0 6 Set concentration vol Enflurane ...

Page 74: ...gh concentration full compensation is not made for the cooling of the anesthetic agent because total saturation of the gas flowing through the liquid vaporizing system does not occur and the output concentration is reduced slightly see 11 8 Influence of Running Time The diagrams show the influence of flow on the concentration delivered after 1 minute at 22 101 3 kPa when operating with Air ...

Page 75: ...11 7 0 1 2 3 4 5 6 1 Output concentration vol Set concentration vol Enflurane Fresh gas flow L min 5 4 3 2 1 0 6 ...

Page 76: ...ts and for this reason maximum effects are given here When changing from one gas mixture to another an additional dynamic effect can occur which may result in a further deviation in concentration until any earlier fresh gas is flushed out of the vaporizer These deviations and their duration will all be greater under the following circumstances 1 The lower the volume of anesthetic agent in the vapo...

Page 77: ...ed value vol x atmospheric pressure kPa 101 3 kPa WARNING z Under no circumstances should the vaporizer ever be used at atmospheric pressure and temperature at which the anesthetic agent could start to boil as the concentration delivered will rise and be uncontrolled 11 7 Influence of Fluctuations in Pressure During ventilation pressure fluctuations on the anesthetic vaporizer can cause a higher c...

Page 78: ...iation from the set value The accuracy given in A Product Specifications applies as long as the temperature of the vaporizer does not fall outside the operating range The diagrams show typical concentration curves over 4 hours and 6 hours of running time respectively measured at 22 and 101 3 kPa A Fresh gas flow of 4 L min concentration set of 1 running time of 4 hours B Fresh gas flow of 10 L min...

Page 79: ...11 11 0 1 2 3 4 5 6 0 1 2 3 4 5 6 G C B A F Concentration delivered vol Enflurane Time h ...

Page 80: ...11 12 ...

Page 81: ...medical devices COUNCIL DIRECTIVE 93 42 EEC of 14 June 1993 concerning medical devices EN 60601 1 IEC 60601 1 Medical electrical equipment Part 1 General requirements for basic safety and essential performance EN 60601 1 6 Medical electrical equipment Part 1 6 General requirements for basic safety and essential performance Collateral standard Usability EN 980 Symbols for use in the labelling of me...

Page 82: ...e 0 to 5 Halothane 0 to 5 A 4 Performance Specifications Range of concentration accuracy maximum value always applies Operating environment 15 to 35 or 0 2 to 10 L min 10 to 15 or 35 to 40 or 10 to 15 L min Set concentration 6 0 20 vol or 20 rel whichever is greater 0 30 0 20 vol or 25 20 rel whichever is greater Set concentration 6 0 25 vol or 20 rel whichever is greater 0 35 0 25 vol or 30 20 re...

Page 83: ...tem Key Filler Quik Fil Pour Fill Isoflurane vaporizer Yes No Yes Sevoflurane vaporizer Yes Yes Yes Enflurane vaporizer Yes No Yes Halothane vaporizer Yes No Yes A 6 Flow Range Flow Range 0 2 to 15 L min 0 2 to 10 L min for concentrations 5 Vol ...

Page 84: ...A 4 FOR YOUR NOTES ...

Page 85: ... filling adapter for enflurane vaporizer 040 000064 00 Key Filler filling adapter for isoflurane vaporizer 040 000065 00 Key Filler filling adapter for sevoflurane vaporizer 040 000066 00 Key Filler filling adapter for halothane vaporizer 040 000063 00 Draining adapter Quik Fil drainage funnel for sevoflurane vaporizer 040 000067 00 ...

Page 86: ...B 2 FOR YOUR NOTES ...

Page 87: ...han or equal to plus or minus multiply copyright C 2 Terminology Terminology Description Air Medical compressed air N2O Medical nitrous oxide O2 Medical oxygen TM Trademark Registered trademark Vol Percentage by volume of anesthetic agent in fresh gas at outlet Unit of output concentration Percentage rel Relative deviation from value in Degree Celsius unit of temperature ...

Page 88: ...ane Hal Halothane Pour Fill While filling fill anesthetic agent into the filler directly While draining open the draining valve by specific key to drain the anesthetic agent into the anesthetic agent bottle Key Filler Adopt filling adapter and bottle neck collar to connect to the anesthetic agent bottle to operate filling and draining anesthetic agent Quik Fil While filling adopt filling adapter t...

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