Penlon Sigma Delta User Instruction Manual
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Penlon Sigma Delta User Instruction Manual

For continuous flow anesthesia
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This manual contains
calibration and service
records for Sigma Delta
Vaporizer, Serial No.
. . . . . . . . . . . . . . . . . . . .
Keep this manual with
the vaporizer at all times
Sigma Delta Vaporizer
User Instruction Manual
Quality and Assurance in Anaesthesia

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Summary of Contents for Penlon Sigma Delta

  • Page 1 User Instruction Manual This manual contains calibration and service records for Sigma Delta Vaporizer, Serial No..... Keep this manual with...
  • Page 2 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 considerable variation effect 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...
  • Page 3 Penlon agent* or contact the operational life of the Sigma Delta Service Department at Penlon vaporizer, we recommend that a Limited. periodic service check should be performed by a Penlon trained *Agent's name and address: engineer.
  • Page 4 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 manual is correct at the date of publication. The policy of Penlon...

  • Page 5: Table Of Contents

    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 CHARACTERISTICS Performance Graphs 7.1.1...
  • Page 6 CONTENTS Pressure Effects 7.3.1 Ambient Pressure 7.3.2 Back Pressure 7.3.3 Intermittent Back Pressure Summary of Performance Specifications 7.4.1 Factors Affecting Output Accuracy 7.4.2 Resistance to Gas Flow Effect of IPPV on Output Effect of Gas Composition on Output Output when Control is at 0 (Zero) Effect of Flush Valve Operation USER MAINTENANCE Servicing...

  • Page 7: 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 8: Warnings And Cautions

    Cautions must be read and modified understood before using this disassembled vaporizer unauthorised person. It should regularly WARNINGS serviced by a Penlon- authorised service agent, General Information trained technician engineer and by no other The user must read and person. familiar...
  • Page 9 WARNINGS AND CAUTIONS Filling and draining the the patient during the filling procedure. vaporizer The filler system must be The vaporizer must be maintained in accordance upright during filling to with instructions minimise risk given User overfilling. Maintenance section. The vaporizer must be anaesthetic agent bottle filled only by suitably to fill the vaporizer if the...
  • Page 10 Contact Service Department at Penlon for Before using the vaporizer advice. Do not use the vaporizer if Anaesthetic drugs must the agent level is not treated visible in the sight glass pharmaceutical product.
  • Page 11 WARNINGS AND CAUTIONS position. selectatec manifold and If a vaporizer has been the rear frame panelling transported with of the machine to allow control open the vaporizer connector position must block to seal correctly on flushed at 5 L/min for ten the manifold.
  • Page 12 WARNINGS AND CAUTIONS CAUTIONS The vaporizer is a flow Anaesthetic machine and direction-sensitive apparatus workstation standards and the direction of gas flow require that means towards the patient must be provided to ensure that gas as indicated by the arrow on cannot pass through more the top label.

  • Page 13: 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 14: Description

    DESCRIPTION 3.1 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 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.
  • Page 15 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.

  • Page 16: Specification

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

  • Page 17: Concentration Control Dial Scale

    From 2 to maximum, by intervals of 0.5% vol The control dial is marked '0' at zero Patents The Sigma Delta is protected by UK and foreign patents. Temperature Range 15 to 35 o C (58 to 95 o F)

  • Page 18: Filling And Draining

    NOTE with a keyed collar. Penlon supply a complete range of agent specific filler adaptors, see Filling the Vaporizer section 10. This system is manufactured in compliance with ISO 5360.
  • Page 19 FILLING AND DRAINING Loosen the clamp screw (4). Remove the plug (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.
  • Page 20 FILLING AND DRAINING 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.
  • Page 21 FILLING AND DRAINING WARNING Draining the Vaporizer Anaesthetic drugs must be treat- ed as a pharmaceutical product. CAUTION To reduce atmospheric pollution in Liquid should never be drained the operating room, it is recom- from a vaporizer into an open mended that vaporizer drainage container and reused.

  • Page 22: Screw Cap (Pour Fill) System

    FILLING AND DRAINING 5.2 Screw Cap Filling Remove the bottle cap and fill the vaporizer slowly and System (Pour Fill) carefully, stopping to check CAUTION the liquid level occasionally. To minimise atmospheric pollution Stop filling when the upper in the operating room, fill the vapor- mark is reached on the filler izer in a fume cupboard or under block.
  • Page 23 FILLING AND DRAINING Draining the Vaporizer container and reused. Contamination is likely. Always dispose of such drained liquid CAUTION as a hazardous chemical. To minimise atmospheric pollution in the operating room, perform Allow the liquid to run into vaporizer drainage in a fume cup- the bottle until the flow board or under an extractor hood.

  • Page 24: Quik-Fil Filling System

    FILLING AND DRAINING Quik-Fil System in the User Maintenance section. WARNINGS The vaporizer must be filled only suitably Do not use the anaesthetic skilled and trained person- agent bottle to fill the nel. vaporizer if the bottle is cracked or the filler con- After filling, remove the nector is loose or broken.
  • Page 25 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 are not damaged. Remove the vaporizer filler block cap and insert the bottle nozzle into the filler block,...
  • Page 26 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.

  • Page 27: Installation

    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 Interlock These vaporizers are designed for installation Selectatec...
  • Page 28 INSTALLATION Installation Removal Carefully offer the vaporizer up to the manifold. NOTE Align the gas connection The concentration control dials of ports with the valve capsule all the vaporizers linked by the on the manifold. (The cap- interlock system must be turned to sule is referred to as the zero before removing the vaporizer valve ‘cartridge' in some...

  • Page 29: Cagemount (23 Mm) Taper Models

    INSTALLATION 6.3 Cagemount (23 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).

  • Page 30: Penlon Off-Line System (Mk.2 And Mk.3)

    Installation on Modura Rail WARNING A vaporizer with cagemount tapers The vaporizer must not be tipped may be fitted with a Penlon clip, or inverted during installation. Part No. 58090, in place of the If the vaporizer has been tipped back bar clamp.

  • Page 31: Drager 'Plug-In' Compatible

    INSTALLATION 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. Carefully offer the vaporizer up to the manifold. Align the gas connection ports with the valve capsule manifold.

  • Page 32: North American Drager Compatible

    INSTALLATION 6.6 North American Drager Compatible (Interlock) Installation 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...

  • Page 33: Pre-Use Checklist - All Models

    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. Check that the vaporizer concentration control is in the 0 (zero) position.

  • Page 34: Performance Characteristics

    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.

  • Page 35: Performance Graphs

    PERFORMANCE CHARACTERISTICS Performance Graphs 7.1.1 Halothane Variation of output with flow rate (Temperature: 20 o C) 5% set 4% set 2% set 1% set 0.6% set 0.2% set 0.2 1 9 10 11 12 13 14 15 Flow rate L/min Variation of output with temperature (Flow rate: 5 L/min) 5% set 4% set...

  • Page 36: Enflurane Models

    PERFORMANCE CHARACTERISTICS 7.1.2 Enflurane Models Variation of output with flow rate (Temperature: 20 o C) 5% set 4% set 2% set 1% set 0.6% set 0.2% set 0.2 1 9 10 11 12 13 14 15 Flow rate L/min Variation of output with temperature (Flow rate: 5 L/min) 5% set 4% set 2% set...

  • Page 37: Isoflurane Models

    PERFORMANCE CHARACTERISTICS 7.1.3 Isoflurane Models Variation of output with flow rate (Temperature: 20 o C) 5% set 4% set 2% set 1% set 0.6% set 0.2% set 0.2 1 9 10 11 12 13 14 15 Flow rate L/min Variation of output with temperature (Flow rate: 5 L/min) 5% set 4% set 2% set...

  • Page 38: Sevoflurane Models

    PERFORMANCE CHARACTERISTICS 7.1.4 Sevoflurane Models Variation of output with flow rate (Temperature: 20 o C) 8% set 7% set 6% set 5% set 4% set 3% set 2% set 1% set 0.6% set 0.2% set 0.2 1 10 11 12 13 14 15 Flow rate L/min Variation of output with temperature (Flow rate: 5 L/min) 8% set...

  • Page 39: Temperature Compensation

    The effect is greatest at low any other pressure the true output settings of the control and low flow will be modified according to the rates, and the Sigma Delta vaporiz- equation: er is designed to comply with the C = S% x 101.3...

  • Page 40: Summary Of Performance Specifications

    PERFORMANCE CHARACTERISTICS 7.4 Summary of Performance Specifications 7.4.1 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.

  • Page 41: Resistance To Gas Flow

    PERFORMANCE CHARACTERISTICS 7.4.2. Resistance to Gas 7.6 Effect of Gas Flow Composition on Output Resistance to gas flow, measured The vaporizer is calibrated with 22 o C (72 o F) pure oxygen and the scale is there- fore most accurate with this gas. 101.3 kPa (1013 mbar, or 14.7 psi), The effect of other gases normally Control position 0 (zero)

  • Page 42: Effect Of Flush Valve Operation

    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%.
  • Page 43 Quik-Fil system - at regular has been serviced (see below). intervals (3 monthly mini- mum, 6 monthly maximum), The Sigma Delta must only be filling and draining must be serviced at an authorised service checked under controlled centre or by Penlon-trained techni-...

  • Page 44: User Maintenance

    Vaporizer Output Do not use water or other liquids. The output of the vaporizer should be checked periodically, either: Draining - Halothane Models as part of the Penlon Service Contract (UK only) Because halothane contains a (ii) Penlon certified stabilising agent which is only...

  • Page 45: Training Course

    (see section specification and schedule 5.1). This will prevent possible output failures damage to the filler block seal. confirmed by a Penlon certified engineer using a refractometer, Output values should be recorded in section 11. The vaporizer serial number...

  • Page 46: References

    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 CAN3 Z168.3 M84, Section 12...

  • 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 E-mail: uksales@penlon.co.uk...

  • Page 48: Service Records

    11. SERVICE RECORDS 11.1 Service Policy The Sigma Delta Vaporizer must be serviced according to the following system: 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.

  • Page 49: Calibration Procedure Using The Riken Analyser

    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.
  • Page 50 SERVICE RECORDS Halothane in Oxygen Riken Factor (using air) Factor (using oxygen) Halothane 0.95 Enflurane 0.99 1.05 Isoflurane 1.06 Sevoflurane 0.99 1.05 Temperature and Barometric Pressure Calibration checks must be performed at a temperature between 19 and 21 o C. The correction factor is ±...
  • Page 51 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. Sample by 2 or 3 squeezes of the hand bulb. Wait for fringe movement to cease before taking the reading. After each resetting of the vapour control, time must be allowed for the output to stabilise.

  • Page 52: Servicing And Repair Details

    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...
  • Page 53 SERVICE RECORDS Date Comments (including any additional work) Signature...
  • Page 54 SERVICE RECORDS Date Comments (including any additional work) Signature...
  • Page 55 SERVICE RECORDS Date Comments (including any additional work) Signature...

  • Page 56: Calibration Check

    SERVICE RECORDS Year One Test Period Vaporizer serial number: Date: Signature: Print name: Carrier Gas Leak Test (at 200 mmHg for minimum 60 secs) Pressure must not drop below 180 mm Hg Tolerance 0 - 0.1 0.14 - 0.26 0.45 - 0.75 0.8 - 1.2 2.4 - 3.6 3.2 - 4.8...
  • Page 57 SERVICE RECORDS Year Two Test Period Vaporizer serial number: Date: Signature: Print name: Carrier Gas Leak Test (at 200 mmHg for minimum 60 secs) Pressure must not drop below 180 mm Hg Tolerance 0 - 0.1 0.14 - 0.26 0.45 - 0.75 0.8 - 1.2 2.4 - 3.6 3.2 - 4.8...
  • Page 58 SERVICE RECORDS Year Three Test Period Vaporizer serial number: Date: Signature: Print name: Carrier Gas Leak Test (at 200 mmHg for minimum 60 secs) Pressure must not drop below 180 mm Hg Tolerance 0 - 0.1 0.14 - 0.26 0.45 - 0.75 0.8 - 1.2 2.4 - 3.6 3.2 - 4.8...
  • Page 59 SERVICE RECORDS Year Four Test Period Vaporizer serial number: Date: Signature: Print name: Carrier Gas Leak Test (at 200 mmHg for minimum 60 secs) Pressure must not drop below 180 mm Hg Tolerance 0 - 0.1 0.14 - 0.26 0.45 - 0.75 0.8 - 1.2 2.4 - 3.6 3.2 - 4.8...
  • Page 60 SERVICE RECORDS Year Five Test Period Vaporizer serial number: Date: Signature: Print name: Carrier Gas Leak Test (at 200 mmHg for minimum 60 secs) Pressure must not drop below 180 mm Hg Tolerance 0 - 0.1 0.14 - 0.26 0.45 - 0.75 0.8 - 1.2 2.4 - 3.6 3.2 - 4.8...
  • Page 61 SERVICE RECORDS Year Six Test Period Vaporizer serial number: Date: Signature: Print name: Carrier Gas Leak Test (at 200 mmHg for minimum 60 secs) Pressure must not drop below 180 mm Hg Tolerance 0 - 0.1 0.14 - 0.26 0.45 - 0.75 0.8 - 1.2 2.4 - 3.6 3.2 - 4.8...
  • Page 62 SERVICE RECORDS Year Seven Test Period Vaporizer serial number: Date: Signature: Print name: Carrier Gas Leak Test (at 200 mmHg for minimum 60 secs) Pressure must not drop below 180 mm Hg Tolerance 0 - 0.1 0.14 - 0.26 0.45 - 0.75 0.8 - 1.2 2.4 - 3.6 3.2 - 4.8...
  • Page 63 SERVICE RECORDS Year Eight Test Period Vaporizer serial number: Date: Signature: Print name: Carrier Gas Leak Test (at 200 mmHg for minimum 60 secs) Pressure must not drop below 180 mm Hg Tolerance 0 - 0.1 0.14 - 0.26 0.45 - 0.75 0.8 - 1.2 2.4 - 3.6 3.2 - 4.8...
  • Page 64 SERVICE RECORDS Year Nine Test Period Vaporizer serial number: Date: Signature: Print name: Carrier Gas Leak Test (at 200 mmHg for minimum 60 secs) Pressure must not drop below 180 mm Hg Tolerance 0 - 0.1 0.14 - 0.26 0.45 - 0.75 0.8 - 1.2 2.4 - 3.6 3.2 - 4.8...
  • Page 65 SERVICE RECORDS Year Ten Test Period Vaporizer serial number: Date: Signature: Print name: Carrier Gas Leak Test (at 200 mmHg for minimum 60 secs) Pressure must not drop below 180 mm Hg Tolerance 0 - 0.1 0.14 - 0.26 0.45 - 0.75 0.8 - 1.2 2.4 - 3.6 3.2 - 4.8...
  • Page 67 Cat No 52606 Doc No D0102UI February 2002 Penlon Limited Radley Road Abingdon OX14 3PH 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...

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