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Penlon Sigma EVA User Manual

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Sigma EVA Vaporizer
A N A E S T H E S I A S O LU T I O N S
5007600-en
REF
REF
IMPORTANT
Commissioning a new vaporizer
Before use on a patient:
Fill the vaporizer with desflurane.
Set a concentration setting of 18%.
Purge at 4 L/min fresh gas for a minimum of 30
seconds.
Refer to section 5.1.
User Manual

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Summary of Contents for Penlon Sigma EVA

  • Page 1 Sigma EVA Vaporizer User Manual A N A E S T H E S I A S O LU T I O N S IMPORTANT Commissioning a new vaporizer Before use on a patient: Fill the vaporizer with desflurane. Set a concentration setting of 18%.
  • Page 3 8: Every 6 months: Operational check, including vaporizer output. Every 2 years: Return to Penlon Ltd in the UK for a full service, including fitment of the vaporizer preventive maintenance kit. Details of service operations that can be carried out by Penlon-trained engineers are given in the Sigma EVA Service Manual.
  • Page 4 Information contained in this 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, Penlon Limited reserves the right to make any changes which may affect instructions in this manual, without giving prior notice.
  • Page 5 Filling the Vaporizer - Baxter SAFE-FIL system ........35 Sigma EVA Vaporizer...
  • Page 6 Appendix 6. Electromagnetic compatibility (EMC) ......... . .57 Sigma EVA Vaporizer...
  • Page 7 Should such a repair become necessary it is recommended that a request for service advice be made to the nearest Penlon accredited agent. This device and any of its constituent parts must be repaired only in accordance with written...
  • Page 8 It may be necessary to take mitigation 6. The vaporizer may malfunction if exposed measures such as (1) reorienting or to excessively high temperatures, e.g. by relocating the Sigma EVA vaporizer (do storage above a radiator. This may affect not remove from the anaesthetic machine calibration.
  • Page 9 Warnings and Cautions 23. Liquid that has been spilled or drained 12. MRI compatibility - The Sigma EVA vaporizer should never be reused. Contamination is is not MRI compatible. likely. Filling the vaporizer Always dispose of this liquid as a hazardous 13.
  • Page 10 40. Anaesthesia system monitors and patient monitors are very desirable aids for the anaesthetist. However, they are not true clinical monitors, as the condition of the patient is also dependent on his respiration and the functioning of his cardiovascular system. Sigma EVA Vaporizer User Manual...
  • Page 11 2. Penlon Sigma EVA vaporizers distributed by a drug company should only be filled with drug from that drug company, to ensure materials compatibility.
  • Page 12 0.2 and 15 litres/min. The Sigma EVA vaporizer is indicated for use for inhalation anaesthesia of desflurane. The Sigma EVA is not used with any other anaesthetic agent such as enflurane, halothane, isoflurane, or sevoflurane.
  • Page 13 WARNING Do not set the control dial between 0% (zero) and the 1% graduation. When turned to zero, the dial will automatically spring outwards into the locked ‘off’ position. Sigma EVA Vaporizer User Manual...
  • Page 14 Indicator 4 flashing Battery in use Repeated single audio tone. No mains power Indicator 2 flashing Battery low Battery in use, Repeated single audio tone. but charge is Indicator 2 flashing rate increases Sigma EVA Vaporizer User Manual...
  • Page 15 1. The visual indication of the alarm condition will continue during the audio pause period. 2. If a vaporizer self-test is initiated during an alarm mute period, the alarm mute will be released . See section 6 .6 . Sigma EVA Vaporizer User Manual...
  • Page 16 The vaporizer filler system comprises the filler cap (1) and filler control bar (2), and is compatible with the SAFE-FIL system and Baxter Suprane (desflurane) anaesthetic agent. For filling instructions, refer to section 6.3 Sigma EVA Vaporizer User Manual...
  • Page 17 Description Interlock Systems 3.5.1 Selectatec-compatible Interlock System The Sigma EVA Selectatec-compatible model can be used on a Selectatec Universal Series Manifold backbar in conjunction with other vaporizers (i.e. from other manufacturers) with a compatible interlock system. Interlock activation 1. Initial operation of the concentration control dial (1) activates the interlock system.
  • Page 18 To isolate the vaporizer from the mains supply, disconnect the cable from the input socket (1) or disconnect the power adaptor cable from the mains supply. Only use the correct Penlon power adaptor (part number 5007115) with the vaporizer. Anaesthetic machine On/Off control NOTE...
  • Page 19 6% set Fresh gas flow: 4 L/min At higher settings the back-up period may be shortened. The back-up period may extend to a maximum of 30 minutes, depending on fresh gas flow rate and concentration setting. Sigma EVA Vaporizer User Manual...
  • Page 20 The vaporizer will then automatically power down. A high priority alarm (audio sequence of 10 tones) will sound and indicator 5 will flash immediately prior to shutdown, to indicate battery discharge. Sigma EVA Vaporizer User Manual...
  • Page 21 1% to 18% The control dial is marked as follows: From 1 to 10% vol by intervals of 0.5% vol From 10% to maximum by intervals of 1% vol The control dial is marked 0% at zero Sigma EVA Vaporizer User Manual...
  • Page 22 It may be necessary to take mitigation measures such as (1) reorienting or relocating the Sigma EVA vaporizer (do not remove from the anaesthetic machine backbar), or (2) shielding the location.
  • Page 23 6% at a flow of 4 L/min) Only use the correct Penlon power adaptor (part number 5007115) with the vaporizer. Fuses WARNING Fuses are not user accessible. Contact Technical Support at Penlon limited if a replacement fuse is required, see section 8.3.3. 4.14 Warm-up Time...
  • Page 24 Carefully remove the vaporizer from the packaging. If possible, retain the original packaging for use when the vaporizer is returned to Penlon Ltd for a service. This will prevent damage during transit. Refer to sections 8.3.1 / 8.4. Remove the transit seals from the inlet and outlet ports on the connector block (1) at the rear of the vaporizer.
  • Page 25 Follow the instructions in the next sections (5.2.1 to 5.4). New vaporizer at commissioning: Carry out a leak test and check the vaporizer output - see section 5.5. Reinstalling a vaporizer: Carry out the pre-use checks listed in section 6.4. Sigma EVA Vaporizer User Manual...
  • Page 26 WARNING To prevent damage to the locking shaft (7), recheck that the gas ports (4) on the vaporizer are correctly engaged with the valve capsules (5) before tightening the locking lever. Sigma EVA Vaporizer User Manual...
  • Page 27 Penlon three-station manifold with interlock system Penlon three-station backbar manifolds on anaesthetic machines built from June 2011 are fitted with an interlock system. Please refer to section 5 in the user manual for your Penlon anaesthetic machine.
  • Page 28 Connecting the Power Supply Connect the electrical power adaptor cable to the socket (1) on the vaporizer top assembly. Only use the correct Penlon power adaptor (part number 5007115) with the vaporizer. NOTE The vaporizer is not equipped with an On/Off switch.
  • Page 29 Purge at 4 L/min fresh gas with a concentration setting of 18%. Purge for a minimum of 30 seconds. Refer to section Agent level: Graduated indication Agent level >80% For further information, see section 3.3 Sigma EVA Vaporizer User Manual...
  • Page 30 2. The vaporizer leak check must be preceded by an anaesthetic machine leak check, see section 5.5.2. 3. The output concentration test should be carried out only by trained technicians or a Penlon–trained engineer, using a calibrated, industry standard, agent analyser. 5.5.1 Preparation WARNING...
  • Page 31 The pressure reading must be greater than or equal to 30 cmH2O (approximately 22 mmHg). Record the value. Reset the flowmeter to zero. Fit the vaporizer to the anaesthetic machine - see section 5.2 Sigma EVA Vaporizer User Manual...
  • Page 32 Connect a 0-400 cmH2O (0-300 mmHg) gauge to the common gas outlet. Note: If a tee-piece is used to mount the gauge, occlude the tee outlet. Fit the vaporizer to the anaesthetic machine - see section 5.2. Sigma EVA Vaporizer User Manual...
  • Page 33 The alarm condition will not affect the leak test results. Turn the concentration dial to 0% (zero) and the flow to minimum. Remove the pressure gauge from the common gas outlet. 10. Proceed to section 5.5.4, below Sigma EVA Vaporizer User Manual...
  • Page 34 0.1% vol., when tested in accordance with BS EN ISO 80601-2-13. Please contact Penlon Technical Support or your local Penlon-trained engineer if you have any questions or issues regarding the installation and test procedures. Sigma EVA Vaporizer...
  • Page 35 Automatic progression to Standby mode: The power supply indicator (5) is illuminated continuously to confirm Standby mode. WARNING Do not use the vaporizer if there is any malfunction. The vaporizer must be checked by a trained engineer. Sigma EVA Vaporizer User Manual...
  • Page 36 The vaporizer is designed for use only with Piramal desflurane and must only be filled from a Piramal Desflurane bottle. 3. The vaporizer must be filled only by suitably skilled and trained personnel. Sigma EVA Vaporizer User Manual...
  • Page 37 10. Liquid that has been spilled should never be used. Contamination is likely. Always dispose of this liquid as a hazardous chemical. 11. After filling: Remove the bottle slowly. Refit the bottle cap and vaporizer filler cap. Sigma EVA Vaporizer User Manual...
  • Page 38 The vaporizer must only be filled from a Piramal Desflurane bottle. Remove the bottle cap and check that the O-ring (4) is in good condition. Carefully insert the bottle nozzle into the filler port (5) and rotate the bottle slowly clockwise. Sigma EVA Vaporizer User Manual...
  • Page 39 Do not tilt the bottle. WARNING Do not use excessive force. Rotate the bottle slowly during removal. 11. The spring in the filling adapter helps the valve in the bottle to close. The filling procedure is completed. Sigma EVA Vaporizer User Manual...
  • Page 40 Liquid that has been spilled should never be used. Contamination is likely. Always dispose of this liquid as a hazardous chemical. 13. Refit the bottle cap. 14. Refit the vaporizer filler cap (2). Do not overtighten. Sigma EVA Vaporizer User Manual...
  • Page 41 Care must be taken to avoid spillage of anaesthetic drugs when filling or draining vaporizers. 5. The vaporizer must be upright during filling. Sigma EVA Vaporizer User Manual...
  • Page 42 Check the agent level indicators (A, B, C): NOTE Agent level indication is most accurate when the vaporizer is in Standby mode. a) If indicator A flashes, a full 240-ml bottle of Suprane (desflurane) can be used to refill the vaporizer. Sigma EVA Vaporizer User Manual...
  • Page 43 13. Remove the bottle, refit the bottle cap. 14. Refit the vaporizer filler cap (2). Do not overtighten. WARNING Liquid that has been spilled should never be used. Contamination is likely. Always dispose of this liquid as a hazardous chemical. Sigma EVA Vaporizer User Manual...
  • Page 44 The warm-up period is variable, depending on the temperature of the agent in the vaporizer. b) During the warm-up period the concentration control is locked. It will not be possible to set a concentration. Sigma EVA Vaporizer User Manual...
  • Page 45 10. Function test the interlock system. Mount another Selectatec-compatible interlock vaporizer on the machine backbar, adjacent to the Sigma EVA. Push in the concentration control dial assembly (7) and rotate anti-clockwise Check that the interlock bolt (8) moves outwards so that only one vaporizer at a time can be turned on.
  • Page 46 Press the audible alarm mute control (3). The audible alarm will be silenced for 2 minutes. Press the control again to cancel the silence command. NOTE The following system fault condition alarms cannot be silenced: 1. System fault. 2. No output Sigma EVA Vaporizer User Manual...
  • Page 47 2, 3, and 4 display a descending sequence, and the audio sounder gives a sequence of three tones. b) The audio sequence is repeated at one minute intervals until the end of the back- up period. Sigma EVA Vaporizer User Manual...
  • Page 48 Powering down the Vaporizer Set the vaporizer concentration control (1) to the 0% (zero) position. The vaporizer will revert to Standby mode. Disconnect the power supply cable (2). The vaporizer will automatically exit operating mode and power down. Sigma EVA Vaporizer User Manual...
  • Page 49 For a period of prolonged storage, check the expiry date of the residual agent in the vaporizer reservoir. When the vaporizer is brought out of storage, carry out the pre-use checks detailed in section 5.5 Sigma EVA Vaporizer User Manual...
  • Page 50 Within area B, at high flow rates and high agent concentration levels (indicated by the blue line (1) on the dial), vaporizer output will be lower than the set concentration. NOTE A low-output alarm may be triggered (see section 3.3.1). Sigma EVA Vaporizer User Manual...
  • Page 51 2-13. Control Dial in ‘Off’ Position The output vapour concentration when the control is in the ‘Off’ position (i.e. set at 0%) will not exceed 0.1% vol (tested in accordance with BS EN ISO 80601-2-13. Sigma EVA Vaporizer User Manual...
  • Page 52 7 .7 above . Effect of Tilting Within the specified tilting angle range during operation, the vaporizer delivers output concentrations within the tolerance specified in BS EN ISO 80601-2-13 . Refer to section 4 .9 . Sigma EVA Vaporizer User Manual...
  • Page 53 User maintenance by non-technical staff is restricted to cleaning the external surfaces of the vaporizer (refer to section 8.2). All other maintenance and regular output checks must be carried out only by Penlon-trained engineers (refer to section 8.3). WARNINGS 1. Exterior panels:...
  • Page 54 8.3.2 Technical Support Contacts For any enquiry regarding servicing or repair of the vaporizer, contact your Penlon Distributor, or communicate directly with: UK and International Penlon Limited, Abingdon Science Park Abingdon, OX14 3NB, UK Tel:...
  • Page 55 If this label (or other labels) is missing, do not use the vaporizer until it has been serviced and checked by Penlon Limited. Electrical Power Supply Unauthorised personnel must not attempt to access or replace: •...
  • Page 56 If damage to the locking shaft (1) is suspected, the device must be referred to a Penlon-trained engineer. 5. Interlock system - Selectatec compatible: Function test the interlock system during the vaporizer calibration test.
  • Page 57 EC territories: follow the requirements of Directive 2002/96/EC Appendix 2. Optional extras and approved accessories WARNING Only use accessories approved by Penlon Ltd. Please contact Penlon Ltd. (see below), or your local Penlon Distributor. UK Sales Tel: 01235 547036 E-mail: uk.sales...
  • Page 58 The system detects that the battery does not have enough power for safe shutdown (in the event of a mains electrical supply failure). iii. Mains power fails during warm-up. The concentration control (2) is not in the 0% (zero) position. Sigma EVA Vaporizer User Manual...
  • Page 59 Power down is indicated by a repeated audio sequence (three tones), and the power status (1) and filler system indicators (2) will flash. Indicator 3 will flash if the battery was recharging. Refer to the instructions and Warnings in section Sigma EVA Vaporizer User Manual...
  • Page 60 Appendix 6. Service mode Service mode is for the use of Penlon-trained service personnel only, and cannot be accessed by the user. Data indicating the software version for the vaporizer can be accessed in this mode. 7. System fault mode Visual and audible alarms are triggered.
  • Page 61 2. Caution (plain background) Agent reservoir empty Power status Mass Agent level Manufacturer Agent reservoir full Possible EMC interference in the vicinity of equipment marked with Desflurane this symbol: Mandatory action Action prohibited Piramal Fill system Sigma EVA Vaporizer User Manual...
  • Page 62 Appendix Appendix 5. References Standards The Sigma EVA vaporizer has been designed in accordance with the following Standards. BS EN ISO 80601-2-13 Medical electrical equipment. Particular requirements for basic safety and essential performance of an anaesthetic workstation. IEC 60601-1 Medical electrical equipment - Part 1: General...
  • Page 63 The user of the EVA vaporizer should assure that it is used in an electromagnetic environment as described below. Changes or modifications to this vaporizer, not expressly approved by Penlon Limited, could result in EMC issues with this vaporizer. Contact Penlon Limited for more information.
  • Page 64 (for which CISPR 11 class B is normally required) this equipment might not offer adequate protection to radio-frequency communication services. The user might need to take mitigation measures, such as relocating or re-orienting the equipment. Sigma EVA Vaporizer User Manual...
  • Page 65 IEC 61000-4-5 ± 0.5, 1 kV line(s) to line(s) for power supply lines ± 0.5, 1 kV line(s) to line(s) for power supply lines ± 2 kV line(s) to earth for input / output lines Sigma EVA Vaporizer User Manual...
  • Page 66 70% UT (30% dip in UT) 0% UT (100% dip in UT) for 250/300 for 25/30 cycles cycles 0% UT (100% dip in UT) for 250/300 cycles Power frequency 30 A/m 30 A/m (50 Hz) Magnetic field IEC 61000-4-8 Sigma EVA Vaporizer User Manual...
  • Page 68 B-1030 Brussels Belgium Part of the InterMed Group © Penlon Ltd, 2021 All rights reserved. Penlon, InterMed and Sigma EVA are trademarks of Penlon Limited. All other trademarks are the property of their respective owners. Penlon Limited Technical Support International Sales...