BleaseFrontline Plus Anaesthesia Machine User Manual Jan 1999 Issue 1

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Part Number 119UMOO2 Issue 1 January 1999

Frontline Plus Anaesthetic Machines

Contents

Contents Product Improvement Responsibilities of the Manufacturer Note to Service Personnel Copyright Trademarks and Acknowledgements Warnings Electrostatic Sensitive Devices (ESD) Warnings and Cautions Cautions Oxygen Monitor Ventilator Vaporizer Symbols and Abbreviations Used on Blease Equipment and in this Manual

vi vi vi vii viii ix x xii xiii xiv xv xvii

1

Introduction 1.2 How to Use This Manual

1.1 1.2

2

Description 2.1 General 2.2 The Frame 2.3 Pneumatic Assembly 2.4 Flowblock Assembly 2.5 The Monitor Shelf 2.6 Detachables

2.1 2.1 2.5 2.5 2.5 2.6 2.6

3

Specification 3.1 Physical 3.1.1 Machine Dimensions 3.1.2 Work Surface Dimensions 3.1.3 Monitor Shelf Dimensions 3.1.4 Bottom Shelf Dimensions 3.1.5 Drawer Dimensions 3.2 Maximum Loading 3.3 Pneumatics/Electrics 3.3.1 Gas-Specific Colour Specifications 3.3.2 Electrical Cable Colour Specifications 3.3.3 Miscellaneous 3.3.4 Common Gas Outlet

3.1 3.1 3.1 3.1 3.1 3.2 3.2 3.2 3.2 3.2 3.3 3.3 3.3

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3.4

3.5

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Frontline Plus Anaesthetic Machines

Technical/Performance Specifications 3.4.1 Controls 3.4.2 Monitoring 3.4.3 Alarms/Indicators 3.4.4 Oxygen Monitor Technical Specification 3.4.5 Regulator Safety Valve Settings 3.4.6 Supplies 3.4.7 Environmental Ancillaries and Optional Features 3.5.1 Standard Features 3.5.2 Optional Fittings 3.5.2.1 Vaporizer Fittings 3.5.2.2 Vaporizers 3.5.2.3 Suction

Installation 4.1 Unpacking and Installing the Cylinders 4.2 Pipeline Connections 4.3 Connecting the Electrical Supply 4.4 Connecting the Oxygen Transducer Part No 70300001 4.4.1 Guidelines for Handling 4.5 Fitting Selectatec Vaporizers 4.6 Fitting an Absorber 4.6.1 Absorber Support Arm Assembly Part No 12200005 4.6.2 Making The Breathing System Connections 4.7 Fitting Suction Units Part Nos 11400001 High 11400025 Venturi 4.8 Fitting Ancillary Equipment 4.9 Ventilators 4.10 Post-Installation Check

4.1 4.1 4.3 4.4 4.4 4.6 4.6 4.9 4.9 4.10

Operation 5.1 Oxygen System and Oxygen Failure Warning Device 5.2 Nitrous Oxide System 5.3 Medical Air System 5.4 Other Gases System 5.5 Oxygen Monitor System 5.5.1 Principles of Operation

5.1

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3.4 3.4 3.4 3.4 3.5 3.5 3.6 3.6 3.7 3.7 3.8 3.9 3.9 3.10

4.10 4.11 4.12 4.12

5.12 5.14 5.15 5.15 5.16 5.16

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Contents

5.5.2 On/Off Switch 5.5.3 Alarms 5.5.4 High Oxygen Alarm 5.5.5 Low Oxygen Alarm 5.5.6 Oxygen Monitor Calibration 5.5.7 Fitting a New Oxygen Sensor 5.5.8 Overall Visual Inspection 5.5.9 Overall Performance Check 5 . 5 . 1 0 Mute Operation 5 . 5 . 1 1 Disconnect Alarm 5 . 5 . 1 2 Oxygen High and Low Alarms 5 . 5 . 1 3 Oxygen Sensor Linearity Controls 5.6.1 On/Off Switch 5.6.2 Flow Controls 5.6.3 Oxygen Flush 5.6.4 Hypoxic Guard 5.6.5 Vaporizers

5.17 5.17 5.17 5.17 5.17 5.18 5.19 5.19 5.19 5.20 5.20 5.20 5.21 5.21 5.21 5.22 5.22 5.23

6

User Maintenance 6.1 User Checking Policy 6.2 Pre-Use Check 6.3 Full System Check 6.4 Cleaning

6.1 6.1 6.1 6.1 6.1

7

Pre-Use Check 7.1 Cylinder and Pipeline Supplies 7.2 Flowblock Assemblies 7.3 Oxygen Failure Warning System Check 7.4 Oxygen Monitor Check 7.5 Leak Test -Vaporizers 7.6 General

7.1 7.1 7.1 7.2 7.2 7.3 7.4

8

Full System Test 8.1 Leak Test 8.2 On/Off Switch and Warning System Checks 8.3 Mechanical Hypoxic Guard Test 8.4 Oxygen Flush Tap Test 8.5 Auxiliary Outlet Test 8.6 Ventilator HP Outlet Test

8.1 8.1 8.2 8.3 8.4 8.4 8.4

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8.7 8.8 8.9

Frontline Plus Anaesthetic Machines

Vaporizer Test Integrated Oxygen Monitor Tests General Test

8.4 8.5 8.5

Appendix A Optional Ventilator Mounting Bracket Index

A.1 I

List of Figures

Figure 1 Frontline Plus Anaesthetic Machine 2.2 Figure 2 Rear Electrical Panel 2.4 Figure 3 Installing the Cylinders 4.2 Figure 4 Oxygen Probe 4.5 Figure 5 BleaSorb Absorber with Bag/Vent Valve 4.8 Figure 6 Absorber Support Arm Mounting Part No 12200005 4.9 Figure 7 Frontline Plus Anaesthetic Machine 5.4 Figure 8 Pneumatic Circuit (Machines produced up to June 1998) 5.6 Figure 9 Pneumatic Circuit (Machines produced from July 1998 with Component Pneumatics) 5.8 Figure 10 Pneumatic Circuit (Machines with Manifolded Pneumatics) 5.10

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Warningsand Cautions

IMPORTANT Read this manual beforeoperating the machine.

Read the Vaporizer manual beforeoperating the machine.

Read the Ventilator manual beforeoperating the machine.

The user must be familiar with the machine and its various functions beforeusing it on a patient.

Frontline Plus Anaesthetic Machines

Warnings and Cautions

Blease Medical Equipment Limited recommends that the machine should be serviced at intervals not exceeding three months. Qualified Service Personnel and genuine spare parts should be used for all servicing and repairs. Blease Medical Equipment Limited will not otherwise assume responsibility for the materials used, the work performed or any possible consequences of the same. In communication with Blease Medical Equipment Limited, quote the model and serial number of the equipment, with the approximate date of purchase. If the unit is being returned for repair, indicate the nature of the fault or the work you require to be carried out. Contact: Blease Medical Equipment Limited Beech House • Chiltern Court • Asheridge Road • Chesham • Buckinghamshire HP5 2PX • England Tel: Fax:

+44 (0)1494 784422 +44 (0)1494 791497

Copyright ©1999, Blease Medical Equipment Limited. All rights reserved. The information contained in this publication may not be used for any other purpose than that for which it was originally supplied. This publication may not be reproduced in part or in whole without the written consent of Blease Medical Equipment Limited.

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Trademarks and Acknowledgements

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The following trademarks and acknowledgements may appear in Blease

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Datum@isa registered trademark of BleaseMedical Equipment Limited

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:=1 LJ ABBOTT LABORATORIES is the trademark of AbbottLaboratories.

Dowty is a trademark of Dowty SealsLimited.

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Drager is a trademark ofDragerwerkAG Germany.

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Dzus is a trademark ofDzus FastenersLimited. Fomblin@isaregistered trademark of RocolLimited.

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Frontline FocusTM is a b;ademarkof BleaseMedical Equipment Limited.

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Frontline Plus@is a registered trademark of BleaseMedical Equipment

Limited. Frontline Genius@isa registered trademark of BleaseMedical Equipment

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Limited. Legrand@isregistered trademark of Legrand Electric Limited.

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Loctite@is a registered trademark of UK Limited.

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Megger is a trademark of AVO Megger Instruments Ltd. E Plug-in@is a registered trademark of Dragerwerk AG Germany. E

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Quik-Fil@is a trademark of Abbott Laboratories.

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Rigel is a trademark of Seaward Electronics Ltd.

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Scotchbrite@isaregisteredh"ademarkof3M.

User

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Manual Issue1 PartNo 119UMOO2

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Warnings

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Thisequipmentmustonly beconnectedto gaspipeline supply lines thatarefitted with pressurereliefvalvesthat limit the supply pressureto lessthan7 bar.

2.

Thefunctioningof thismachinemaybeadverselyaffectedby the operationof equipmentsuchashighfrequencysurgical (diathermy)equipment,defibrillatorsorshortwavetherapy equipmentin thevicinity. Increasingthe distancefrom such equipmentwill minimiseanypossibleinterference.

3.

Prior to connectingthemachineto a patientcarry outthepre-use checkto verify correctalarmoperation.Toverify the°2 alarm,set theflowmetersto givea concenuationof 50%oxygen.Usingthe conuolson theoxygenmonitorpanel,setthe low oxygenlevelto 60%andverify the oxygenlow alarmoperates.Setthe high oxygenalarmlevel to 40%and verify thatthe oxygenhigh alarm operates.

4.

The oxygen flow can only be reduced to zero by turning the ON / OFF switch to the OFFposition. Excessiveforce on the oxygen control knob may damagethe hypoxic guard.

5.

Where mains socketsare fitted, it should be noted that 'The connection of EQUIPMENT to the AUXILIARY MAINS SOCKET OUfLET(S) may increase the patient leakage currents to values exceeding the allowable limits in the event of a DEFECTIVE PROTECTIVE EARTH CONDUCTOR'.

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6.

To avoid explosionhazards, flammable anaesthetic agentssuch as ether and cyclopropane must not be used in thesemachines. Only anaestheticagentswhich comply with the requirements on nonflammable anaestheticagentsin IEC 601-2-13'Specification for Anaesthetic Machines', are suitable for use in thesemachines.

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As thesemachinesare not suitable for use with flammable anaestheticagentssuch as ether and cyclopropane the use of antistatic breathing tubes and face masksis not necessary.

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Warningsand Cautions

FrontlinePlusAnaestheticMachines !': ~

The use of antistatic or electrically conductive breathing tubes when utilising high frequency surgery equipment may cause burns and is therefore not recommended in any application that involves such apparatus.

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Before removing any accesscovers,isolate from mains supply by removing the mains plug from the supply socket.

9.

The equipment must be periodically checked and maintained to ensureproper operation.

10.

Performanceof the equipment may be affected attemperatures below 10°C(50°F)and above 400C(104°F).

11

The performance of the anaestheticmachines and vaporizers may be degraded if the two are mismatched. Referto the vaporizer manufacturer's instruction manual beforeuse.

12.

If the integrated oxygen analyser is not fitted, an oxygen analyser complying with ISO 7767shall be used when the anaesthetic machine is in use.

13.

The units use semiconductor devices which are susceptible to damageby overloading, reversed polarity, electrostatic discharge and excessiveheat or radiation. Avoid hazards such as reversal of batteries,prolonged soldering, strong RF fields or other forms of radiation, use of insulation testers or accidentally applied short circuits. Even the leakage current from an unearthed soldering iron may causetrouble.

Electrostatic Sensitive Devices (ESD) Warnings and Cautions All ESDmust be stored in approved conductive packaging, tubes, shipping bags,foam or tote bins.

All personshandlingESDmustbe properlygroundedvia a lMD resistivegroundedwrist strap. Cover all ESDbench tops with grounded conductive mats and connect all work surfacesand equipment to earth ground.

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User

Manual Issue 1 Part No 119UMO02

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Transport all assembliescontaining ESDin a conductive bag or container. DO NOT use cellophaneadhesive tape to wrap DW (dual in-line package)tubestogether.

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DO NOT handle ESDby their pins or mix them with other routine electronic parts.

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Never place ESDon ungrounded surfaces or leave them unattended in an openarea.

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Avoid cellophanewrappers, synthetic (non-conductive) carpeting, warm or cool air blasts,Styrofoam coffee cups, etc when working with ESD. Use only properly designed heat lamps, heat chambers and/ or ,antistatic' quick-chill sprays during troubleshooting or stress testing procedures.

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In particular electronic assembliesin the Frontline Plus range of machines are easily damaged by ESDand require special handling.

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The following assembliesin the Frontline Plus °2 Monitor are easily damaged by electrostaticdischargesand require special handling:

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Backlight Dimmer Switch PCB InverterjInterface PCBAssembly

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Oxygen SensorInterfacePCB Assembly

(12000105) (12000080) (11900076) (12100078) (12100075) (11900075)

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Do not leave gas cylinder valves open if the pipeline supply is in use and the system master switch is turned ON. Pressuresfrom both supplies may becomeequal and, if simultaneously used, cylinder supplies could be depleted, leaving an insufficient reserve supply in caseof pipeline failure. The hypoxic guard control system only ensuresthat oxygen-nitrous mixtures will have a minimum (nominal 25%)oxygen concentration. HYPOXIC MIXTURES MAYBE DEUVERED IF GASESOTHER THAN OXYGEN, Nn'ROUS OXIDE OR AIR ARE USED,OR WHEN OPERAnNG AT LOW OXYGEN FLOW RATES. When using carbon dioxide, as an additional gas,make sure the proportions of all gasesare carefully adjusted in accordancewith acceptedclinical practice. Gas mixtures within the breathing systemmust be monitored when using thesegases. Leaking gasesand vapours (downsueam of the flow conuol valves and Oxygen Flush valve) may deprive the patient of metabolic gasesand anaestheticagent may pollute the atmosphere. Teststhat detect leaks must be performed frequently. If detected,leakagemust be reduced to an acceptablelevel.

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Do not use the anaesthesiasystem if the hypoxic guard contTolsystem does not operate within permitted ranges. Using an incorrectly operating contTolsystem may result in incorrect gasmixtures, and injury to the

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When occluding the breathing system for testpurposes, do not use any objectsmall enough to slip completely into the system. Objectsin the breathing systemcan interrupt or disrupt the delivery of breathing system gases,possibly resulting in injury to the patient. Before using the breathing system on a patient, always checkthe breathing system componentsfor foreign objects.

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Warningsand Cautions

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The voltage for the systemis factory set. Do not changethe original factory setting. Other systemschangesmust be made before changing the voltage setting. H the available voltage differs from the voltage setting, call a qualified servicerepresentative to carry out all the required system changes.

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Do not place materials weighing more than 30kg on the bottom she]f, or more than 50kg on the upper monitor she]f. Overloading may cause damage to the shelves or causeinstability.

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Secureany equipment placed on the shelves.

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To avoid stripping threads,do not use tools on the yoke gate T screws.

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Use only one cylinder gasketper yoke. Using more than one gasketcould cause cylinder gasleakage.

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Defective oxygen-sensorcartridges may leak electrolyte, which is caustic. Use extreme carewhen handling oxygen-sensorcartridges. If any oxygen-sensorshows signsof leakagethen do not use it If you get the electrolyte in your eyes,flush with water immediately, then seekmedical attention.

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Position the oxygen sensor'scable with care. If the cable is pinched or cut, the oxygen monitoring may not function correctly.

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Do not use the anaesthesiasystemwithout proper functioning oxygen monitoring installed. When used, the oxygen sensoradaptor and the ventilator's pressure sensorpatient circuit adaptor must be connectedto the inspiratory side of the patient breathing system. If thesedevices are not correctly connected to the inspiratory side of the patient breathing system, oxygen and pressure monitoring and related alarms will not function properly.

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User Manual PartNo: 119UMOO2

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WarningsandCautions

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Never immerse any part of the oxygen sensorassemblyin cleaning solution as immersion will destroy the sensor's electrical contacts.

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Do not use cold sterilization, solvents or cleaning agentsto clean the oxygen sensorcartridge. Thesesubstancesmay damagethe oxygen sensorcartridge.

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Always perform the Pre-UseCheckprocedures for oxygensensing functions after replacing the sensorcaruidge.

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Do not remove oxygen sensingcartridges from their protective packaging until just before installation of the cartridges.

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When in use, the oxygen sensor probe should always point down to help reduce condensation on the sensorsurfaces. Condensation on the sensor may affect patient data.

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Ventilator

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The volume sensormust be correctly installed at either the distal location in the patient system's expiratory limb or the proximal end of the Y connector. If the sensoris installed incorrectly, volume data will be inaccurateand associatedalarms, including the low minute volume alarm will not function properly.

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Position the volume sensor's cable with care. If the cable is pinched or cut, the ventilator's volume monitoring may not function correctly.

~i Do not connectthe ventilator or absorber exhaust directly to a vacuum ~i source. The vacuum may remove required gasesfrom the breathing ~i system. Ventilator inoperative messagesindicate that a problem existsin the ~i ventilator. Do not attempt to use the ventilator while a ventilator message E. is displayed. I E i

Do not attempt to use the ventilator if the alarm mute button will not silence alarms.

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User Manual

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Part No 119UMOO2

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WARNING: If an alarm condition cannot be resolved, do not continue to use the system.

Sterilise the bellows assemblyperiodically to minimise the risk of cross infecting patients. Use a sterilization schedule that complies with your institution's infection control and risk managementpolicy. Only use Bleaseapproved sterilization methods.

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If any foreign materials or liquids are trapped in the driving gas circuit, or the pop off valve or the bellows basethey could impair the valve's operation. Do not use the bellows assemblyif you suspectthat materials are trapped. Have the assemblyrepaired by trained service personnel.

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Do not autoclave the ventilator bellows assembly. Autoclaving may damagethe unit.

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Perform the Pre-UseCheckprocedures after cleaning and sterilizing the

bellows.

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Always perform the Pre-UseCheckprocedures for volume sensing functions after cleaning or replacing the volume sensor. Referto the ventilator's user manual.

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Do not use any vaporizer that is visibly misaligned on the manifold or that, when it is locked, can belifted off the manifold. Incorrect mounting may result in incorrect delivery of gases.

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A vaporizer is calibrated and labelled for one agent only. Do not fill with anything other than the designated agent.

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If a vaporizer is filled with the wrong agent, draining will not eliminate the agent, becausethe wick will have absorbed some of the agent. The wick must be thoroughly cleanedand dried by tramed service personnel.

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The vaporizers must be completely upright for the sight glassto properly indicate agentlevels.

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User Manual Issue 1 PartNo: 119UMO02

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I Never oil or greaseany oxygen equipment unless the lubricant used is made and approved for this type of service. In general, oils and greases oxidise readily, and -in the presenceof oxygen -will burn violently. Fomblin is the recommended oxygenservice lubricant (stock number

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ST7014). After performing any maintenance or repair procedure, always verify proper operation of the systembefore returning to use.

Usecleaningsolutionsparingly. Do notsaturatesystemcomponents. Excessivesolutioncandamageinternaldevices. Following ethylene oxide sterilization, quarantine the equipment in a well ventilated areato allow dissipation of absorbed ethylene oxide gas. In somecases,aeration periods of sevendays or more may be required. Aeration time canbe decreasedwhen special aeration devices are used. Follow the sterilizer manufacturer's recommendationsfor aeration periods required.

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User Manual

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Issue 1

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Symbols and Abbreviations Used on Blease Equipment and in this Manual bpm BPM

Breaths perminute

cmHp CPAP

Gaugepressure expressed in centimetres of water Continuous positiveairwaypressure

PEEP I:ERatio

Positive endexpiratory pressure A ratioof inspiratory to expiratory time

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WARNWG:Thereis dangerof personal injuryto the useror patient

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Furtherrelevantor helpfulinformation

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directionof the thickeningline, an

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Litres per minute

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Millilitres

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Pounds per square inch

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Confers approval under the European Medical Device Directive

User Manual Issue 1 Part No 119UMOO2

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Frontline Plus Anaesthetic Machines

1 Introduction

1 Introduction This manual describes the Frontline Plus range of anaesthetic machines and the instructions required in order to install, set up, operate and maintain these machines. The information applies to the 690, 560, 440 machines. If an integrated oxygen monitor is fitted, refer to the Oxygen Monitor section in this manual. For information on vaporizer operation, refer to the vaporizer operating manual. Pay special attention to the Warnings and Cautions section at the beginning of this manual and any that appear throughout. Before any attempt is made to set up, use or operate this machine, familiarise yourself with the Blease Frontline Focus Anaesthesia System by reading through this entire manual and the machine’s associated documentation. Also read the manuals for any optional monitors and accessories installed in the system. Any adaptation, modification or procedure not recommended by Blease Medical Equipment Ltd or their agents may affect any warranty relating to the machine. Requests for advice, assistance or servicing facilities should be addressed to Blease Medical Equipment Ltd or an authorised Blease Medical Equipment Ltd agent. Read the User Responsibility statement; it describes what is expected of you to maintain the system. Read the Warranty; it describes Blease Medical Equipment Ltd’s responsibility in case of a functional defect. Keep this manual with the system to refer to and to answer any questions that arise about the system’s operation, maintenance or, if necessary, repair.

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