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Penlon Sigma Delta User Manual

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Sigma Delta Vaporizer
User Manual
ANAESTHESIA SOLUTIONS

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Summary of Contents for Penlon Sigma Delta

  • Page 1 Sigma Delta Vaporizer User Manual ANAESTHESIA SOLUTIONS...
  • Page 2 Always give as much of the contact the nearest accredited following information as possible: Penlon agent*, or contact the Type of equipment Service Department at Penlon Product name Limited (or Penlon Inc. in the USA). Serial number Approximate date of purchase Apparent fault...
  • Page 3 Anaesthetic systems have information on the function, routine capability deliver performance and maintenance mixtures gases checks, applicable to the Penlon vapours to the patient which Sigma Delta vaporizer. could cause injury or death Information contained unless controlled manual is correct at the date of qualified anaesthetist.

  • Page 4: Table Of Contents

    6.2.1 All Models 6.2.2 Selectatec Compatible Models (with interlock) 6.2.3 Cagemount (23 mm) Taper Models 6.2.4 Penlon Off-line Mounting System 6.2.5 Drager 'Plug-in' Compatible (interlock) 6.2.6 North American Drager Compatible (interlock) PRE-USE CHECKS Output check - Commissioning a new vaporizer...
  • Page 5 CONTENTS PERFORMANCE CHARACTERISTICS Performance Graphs 8.1.1 Halothane Models 8.1.2 Enflurane Models 8.1.3 Isoflurane Models 8.1.4 Sevoflurane Models Temperature Compensation Pressure Effects 8.3.1 Ambient Pressure 8.3.2 Back Pressure Summary of Performance Specifications 8.4.1 Output Accuracy 8.4.2 Resistance to Gas Flow Effect of IPPV on Output Effect of Gas Composition on Output Output when Control is in the ‘Off’...

  • Page 6: User Responsibility

    Penlon Limited or its labels and notices when checked, appointed agents. assembled, operated, maintained and serviced in accordance with This vaporizer must only be these instructions provided.

  • Page 7: Warnings And Cautions

    It should personnel. be regularly serviced by a Anaesthetic drugs are poisonous Penlon-authorised service agent, and there is evidence that there trained technician or engineer is a health hazard to personnel and by no other person.
  • Page 8 Withdraw the vaporizer from use The vaporizer control must be in if it has been overfilled. the 0 (zero) position during the Contact Penlon Service filling or draining process. Department for advice. Overfilling and/or spilling may occur if the control is not in the 0 Anaesthetic drugs must be (zero) position.
  • Page 9 WARNINGS AND CAUTIONS Before using the vaporizer Anaesthetic machine designs are constantly evolving, and new Do not use the vaporizer if the models may differ dimensionally agent level is not visible in the from existing equipment. sight glass, or the level is above It is the user's responsibility to the maximum mark or below the ensure that the configuration of...
  • Page 10 WARNINGS AND CAUTIONS maintain the level between the Patient monitoring: minimum and maximum marks. a) Always use an anaesthetic agent monitor that complies with The vaporizer control must be in the latest relevant standard. the zero (0) position during the b) Always monitor oxygen...
  • Page 11 Vaporizers without interlock devices or systems must only be used on machines which only have one vaporizer mounting station. Penlon Sigma Delta vaporizers distributed by a drug company should only be filled with drug from that drug company, to ensure materials compatibility.

  • Page 12: Purpose

    PURPOSE The Sigma Delta Vaporizer is designed for incorporation in the fresh supply system 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.

  • Page 13: Description

    DESCRIPTION Operating Principles Each model is uniquely designed and tested for use only with the drug specified on the filler block. The vaporizer contains a chamber, the base of which holds the anaesthetic agent in liquid form. A wick ensures that the upper part of the chamber is filled with the saturated vapour of the agent.
  • Page 14 DESCRIPTION Interlock Models When the vaporizer is mounted on the anaesthetic machine backbar with other interlock vaporizers, initial operation concentration control dial activates the interlock system ensuring that only one of the vaporizers can be in use at any time. The interlock deactivates as soon as the control dial is returned to the locked out zero position.

  • Page 15: Specification

    SPECIFICATION Physical Dimensions Width Height Depth Cagemount Selectatec Compatible with Interlock Drager 'plug in' Compatible Dimensions given above are in millimetres NOTE For depth of Screw Cap Filler models, subtract 11 mm from the depth dimensions given above. Weight Approximate weight: 4.8 kg. Capacity Volume at MAX mark 250 ml (nominal)

  • Page 16: Concentration Control Dial Scale

    SPECIFICATION Concentration 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 Environmental Operating Temperature Range 15 to 35°C (58 to 95°F) Storage Temperature Range...

  • Page 17: Filling And Draining

    CAUTIONS Penlon Sigma Delta vaporizers distributed by a drug company should only be filled with drug from that drug company, to ensure Filling the Vaporizer materials compatibility.
  • Page 18 FILLING AND DRAINING Tighten the adaptor to ensure an airtight joint, which must be maintained throughout the filling operation. WARNING Failure to observe this instruction may result in overfilling. Loosen the clamp screw (4). Remove the plug (5). Insert the keyed end of the bottle adaptor (2) fully into the vaporizer receiver.
  • Page 19 FILLING AND DRAINING Close the filler control (6). 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.
  • Page 20 FILLING AND DRAINING Draining the Vaporizer WARNING Anaesthetic drugs must be treated as a pharmaceutical product. CAUTION To reduce atmospheric pollution in Liquid should never be drained operating room, from a vaporizer into an open recommended that vaporizer container and reused. drainage should be performed in a Contamination is likely.

  • Page 21: Screw Cap Filling System (Pour Fill)

    Stop filling when Penlon Sigma Delta vaporizers the upper mark (4) is reached on distributed by a drug company the filler block. should only be filled with drug from...
  • Page 22 FILLING AND DRAINING Draining the Vaporizer CAUTION To minimise atmospheric pollution in the operating room, perform vaporizer drainage in a fume cupboard or under an extractor hood. WARNING The vaporizer must be either secured anaesthetic machine or free standing on a level table, so that in either case it is upright during the draining process.

  • Page 23: Quik-Fil System

    This may cause a vapour and fresh gas leak. CAUTIONS 6. The filler system must be 1. Penlon Sigma Delta vaporizers maintained in accordance with distributed by a drug company the instructions given in the should only be filled with drug User Maintenance section.
  • Page 24 FILLING AND DRAINING Quik-Fil System - Filling the Vaporizer Check that vaporizer concentration control is in the off ('0') position. Remove the yellow protective cap from the anaesthetic agent bottle filler, checking that the bottle and filler mechanism damaged. Remove the vaporizer filler block cap and insert the bottle nozzle into the filler block, Rotate the bottle to align the bottle filler keys...
  • Page 25 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. Remove the yellow protective cap from an empty sevoflurane bottle. Insert the bottle nozzle into the drain funnel.

  • Page 26: Installation

    6. INSTALLATION Gas Port Transit Seals All new 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. Installing the Vaporizer on the Anaesthetic Machine WARNING Anaesthetic machine designs are constantly...

  • Page 27: Selectatec Compatible Models (With Interlock)

    Manifold with interlock system Locking Lever Penlon three station backbar Interlock Bolts manifolds on anaesthetic machines Backbar Manifold Locking Shaft built from June 2011 are fitted with an interlock system.
  • Page 28 INSTALLATION Anaesthetic machine layout vaporizer correctly engaged with the valve capsule WARNING before tightening the locking lever. Anaesthetic machine designs are constantly evolving, Pre-use Checks models may differ dimensionally Interlock System - check that from existing equipment only one vaporizer at a time can be turned on.

  • Page 29: Cagemount (23 Mm) Taper Models

    INSTALLATION 6.2.3 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 conical tapers have the male taper (1) (Inlet port) on the left and the female taper (2) on the right (viewing...

  • Page 30: Penlon Off-Line Mounting System

    Modura rail A vaporizer with cagemount tapers anaesthetic machine and may be fitted with a Penlon mounting secure in place by moving clip, Part No. 58090, in place of the the lever into its 'locked on' backbar clamp. The vaporizer may position.

  • Page 31: Drager 'Plug-In' Compatible (Interlock)

    INSTALLATION 6.2.5 Drager 'Plug-in' Compatible (interlock) Installation NOTE 1. When installing two vaporizers only on a three station manifold, centre station must occupied by one of the vaporizers. 2. Not compatible with the Drager auto exclusion system. Locking lever Interlock bolts Carefully offer the vaporizer Backbar manifold locking shaft up to the manifold.

  • Page 32: North American Drager Compatible (Interlock)

    To secure the vaporizer to the carry out pre-use checks: manifold, use two M4 x 30 (a) Section 7.1 (installing a new screws (Penlon Part No. 01267) vaporizer) and fan-type lock washers. (b) Section 7.2 (reinstalling a From the rear of the anaesthetic vaporizer).
  • Page 33 INSTALLATION Interlock Function Check and Adjustment Check that only one vaporizer at a time can be turned on. If necessary, adjust the position of the interlock screw (3) on the vaporizer to ensure that the system functions correctly (see 1 and 2, below): Adjustment to be carried out by suitably...

  • Page 34: Pre-Use Checks

    Note: If a Output concentration tests should be tee-piece is used to mount carried out only by trained persons or the gauge, occlude the tee a Penlon–trained engineer, using a outlet. suitable purpose-made calibrated Carry out a leak test: agent analyser, e.g.

  • Page 35: Daily Pre-Use Check List

    Please contact Penlon is securely closed. On key fill Technical Service or your models, check that the filler local Penlon-trained engineer plug is fully inserted and that if you have any questions or the clamp screw is fully issues regarding tightened.

  • Page 36: Performance Characteristics

    PERFORMANCE CHARACTERISTICS Performance Graphs NOTE Variation of concentration output with (a) flow rates and (b) tem- perature are shown in this section. The output from individual units may vary slightly from the performance curve shown. 8.1.1 Halothane Models Variation of output with flow rate (Temperature: 20°C) value 0.6% 0.2%...

  • Page 37: Enflurane Models

    PERFORMANCE CHARACTERISTICS 8.1.2 Enflurane Models Variation of output with flow rate (Temperature: 20°C) value 0.6% 0.2% 0.2 1 9 10 11 12 13 14 15 Flow rate L/min Variation of output with temperature (Flow rate: 4 L/min) value 0.6% 0.2% Temperature °C...

  • Page 38: Isoflurane Models

    PERFORMANCE CHARACTERISTICS 8.1.3 Isoflurane Models Variation of output with flow rate (Temperature: 20°C) value 0.6% 0.2% 0.2 1 9 10 11 12 13 14 15 Flow rate L/min Variation of output with temperature (Flow rate : 4 L/min) value 0.6% 0.2% Temperature °C...

  • Page 39: Sevoflurane Models

    PERFORMANCE CHARACTERISTICS 8.1.4 Sevoflurane Models Variation of output with flow rate (Temperature: 20°C) value 0.6% 0.2% 0.2 1 10 11 12 13 14 15 Flow rate L/min value Variation of output with temperature (Flow rate : 4 L/min) 0.6% 0.2% Temperature °C...

  • Page 40: Temperature Compensation

    PERFORMANCE CHARACTERISTICS Temperature At any other pressure the true output will be modified according to Compensation the equation: Temperature compensation C = S% x 101.3 provided by the operation of a variable resistance valve in the bypass passage. P is absolute pressure in kPa. The design provides compensation C is delivered concentration vol%, full...

  • Page 41: Summary Of Performance Specifications

    PERFORMANCE CHARACTERISTICS Summary of Effect of IPPV on Performance Output Specifications IPPV: Intermittent positive pressure ventilation. 8.4.1 Output Accuracy When tested in accordance with ISO 80601-2-13*, output will not Under calibration conditions deviate from the set concentration (temperature at 22°C ±1°C at sea by more than +30% / -20%.

  • Page 42: Output When Control Is In The 'Off' (0) Position

    PERFORMANCE CHARACTERISTICS 8.7 Output when Control is in the ‘Off’ (0) position Output vapour concentration when the control is in the ‘Off’ position (i.e. set at 0) will not exceed 0.05% vol., when tested in accordance with ISO 8835-4. Effect of Flush Valve Operation When tested in accordance with ISO 8835-4 the operation of the flush...

  • Page 43: User Maintenance

    The Selectatec compatible until it has been serviced. vaporizer locking system should be inspected during The Sigma Delta must only be the vaporizer calibration test, serviced at an authorised service and if damage to the locking centre Penlon-trained shaft is suspected, the device...

  • Page 44: Cleaning And Sterilisation

    USER MAINTENANCE Interlock system vaporizers - drained periodically of all liquid and function test the interlock the liquid disposed of as a system during the vaporizer hazardous chemical. calibration test. vaporizer drained periodically, the stabilising agent Quik-Fil system - at regular will accumulate in the vaporizer intervals (three-monthly...

  • Page 45: Returning The Vaporizer For Service Or Repair

    USER MAINTENANCE Returning the Vaporizer for Service or Repair Returning the vaporizer to Penlon Ltd 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)

  • Page 46: References

    10. REFERENCES Standards The Sigma Delta vaporizer has been designed in accordance with the following Standards. (a) General EN ISO 80601-2-13 Inhalation anaesthesia systems - Part 4: Anaesthetic vapour delivery devices ISO 5356-1 Anaesthetic and respiratory equipment - conical connectors - Part 1: Cones and sockets...

  • Page 47: Ordering Information

    Various combinations of agent, concentration output, and connector block type are available with either agent specific filler, screw cap, and Quik-Fil filler systems For further information: Contact your distributor, or Customer Service at Penlon Ltd. Tel: 01235 547036 Fax: 01235 547023 uk.sales@penlon.com...
  • Page 48 Cat No 52606 / Doc No D0114 UI March 2014 Part of the InterMed Group Copyright © Penlon Ltd 2014 Penlon Limited Abingdon Science Park Barton Lane, Abingdon OX14 3NB, UK Technical Support International Sales UK Sales Tel: +44 0) 1235 547076...

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