AV-S VentilatorRemote Display Module and Interface for use with A200SP AbsorberUser Manual

Servicing and Repairs

In order to ensure the full operational life of thisventilator, servicing by an engineer trained bythe manufacturer should be undertakenperiodically.

The ventilator must be serviced to the followingschedule:

(a) Six monthly service - inspection andfunction testing.

(b) Annual service.(c) Five year major service including battery

replacement.

Details of these operations are given in theService Manual for the AV-S, available only forengineers trained by the manufacturer.

For any enquiry regarding the servicing orrepair of this product, contact Keomed PLN.

Keomed PLN11515 K-Tel DriveMinnetonkaMN 55434

Always give as much of the followinginformation as possible:

1. Type of equipment2. Product name3. Serial number4. Approximate date of purchase5. Apparent fault

IMPORTANT

(i)

This manual has been produced to provideauthorised personnel with information on thefunction, routine performance and maintenancechecks applicable to the AV-S AnaesthesiaVentilator.

Information contained in this manual is correctat the date of publication.The policy of the manufacturer is one ofcontinued improvement to its products.Because of this policy, the manufacturerreserves the right to make any changes whichmay affect instructions in this manual, withoutgiving prior notice.

Personnel must make themselves familiar withthe contents of this manual and the machinesfunction before using the apparatus.

FOREWORD

(ii)

THE IMPORTANCE OF PATIENTMONITORING

WARNING

Anaesthetic systems have the capabilityto deliver mixtures of gases and vapoursto the patient which could cause injury ordeath unless controlled by a qualifiedanaesthetist.

There can be considerable variation in theeffect of anaesthetic drugs on individualpatients so that the setting andobservation of control levels on theanaesthesia systems does not in itselfensure total patient safety.Anaesthesia system monitors and patientmonitors are very desirable aids for theanaesthetist but are not true clinicalmonitors as the condition of the patient isalso dependent on his respiration and thefunctioning of his cardio-vascular system.

IT IS ESSENTIAL THAT THESEELEMENTS ARE MONITOREDFREQUENTLY AND REGULARLY ANDTHAT ANY OBSERVATIONS ARE GIVENPRECEDENCE OVER MACHINECONTROL PARAMETERS IN JUDGINGTHE STATE OF A CLINICAL PROCEDURE.

Page No.USER RESPONSIBILITY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1

1. WARNINGS AND CAUTIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22. PURPOSE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7

3. DESCRIPTION3.1 General . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 83.2 Ventilation Cycle . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10

3.3 Pneumatic System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 143.3.1 System Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 143.4 Electrical System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15

3.5 Control Panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 163.5.1 Touchscreen Operation and Navigator wheel / push-button . . . . . . . . . . . . 163.5.2 User Adjustable Parameters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 173.5.3 Operational capability . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 173.5.4 Output Compensation Functions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 183.6 Interface with PrimaSP2 and A200SP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19

3.7 Ventilation Modes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 203.7.1 Standby Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 203.7.2 Volume Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 213.7.3 Pressure Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 223.7.4 Spontaneous Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23

3.7.5 Advanced Spontaneous Breathing Modes . . . . . . . . . . . . . . . . . . . . . . . . . . . 24 3.7.5.1 SIMV (Synchronised Intermittent Mandatory Ventilation) . . . . . . . . . . . . . 24 3.7.5.2 SMMV (Synchronised Mandatory Minute Ventilation) . . . . . . . . . . . . 253.7.5.3 PSV (Pressure Supported Ventilation) . . . . . . . . . . . . . . . . . . . . . . 263.7.5.4 PEEP ( Positive End Expiratory Pressure) . . . . . . . . . . . . . . . . . . . . . . 27

3.8 On-screen Menus . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 283.9 Spirometry . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 293.10 Display Waveforms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 293.11 Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30

3.12 Oxygen Monitor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 313.12.1 System Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 313.12.2 The MOX-3 Oxygen Sensor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 313.12.3 Menus . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 323.12.4 Display . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 333.12.5 Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 333.12.6 Alarm Mute. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33

4. SPECIFICATION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34Ventilator . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34Oxygen Monitor . .. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37

CONTENTS

(iii)

CONTENTS

(iv)

5. PRE-OPERATION PROCEDURES5.1 Ventilator Set-up . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 395.1.1 Mounting the Ventilator . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 395.1.2 Electrical Power Connections . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 395.1.3 Ventilator Gas Supply . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 395.1.4 Breathing System Schematic . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 395.1.5 Bellows Drive Gas . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 435.1.6 Anaesthetic Gas Scavenging System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 435.1.7 Printer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 435.1.8 Breathing System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 435.1.9 Spirometer Connections . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 445.1.10 Pressure Monitor Connections . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 465.1.11 Bellows Assembly . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47

5.2 Pre-use Checklists . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 485.2.1 Daily Checklist . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 485.2.2 Function Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 495.2.3 Weekly Checklist . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 50

5.3 Oxygen Monitor Set-up . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 515.3.1 Installation . . . . . . . .. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 515.3.2 Calibration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 515.3.3 Sensor Low Indication . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 535.3.4 Setting the High and Low O2 Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 53

6. USER MAINTENANCE6.1 Service Schedule . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 546.2 Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 546.2.1 Outside Surfaces . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 546.2.2 Bellows Assembly . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 546.2.3 Spirometer Sensors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 546.2.4 Oxygen Monitor Sensor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 546.2.5 Patient Connector Block . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 55 6.3 Sterilisation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 566.4 Oxygen Monitor Sensor Replacement . . . . . . . . . . . . . . . . . . . . . . . . . . . . 57

7. APPENDIX 1. Back-up Battery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 582. Menu System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 593. Ventilator Spirometry System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 62

This anaesthesia ventilator has been built toconform with the specification and operatingprocedures stated in this manual and/oraccompanying labels and notices whenchecked, assembled, operated, maintainedand serviced in accordance with theseinstructions.

To ensure the safety of this device it must bechecked and serviced to at least theminimum standards laid out in this manual.A defective, or suspected defective, productmust not under any circumstances be used.

The user must accept responsibility for anymalfunction which results from non-compliance with the servicing requirementsdetailed in this manual.

Additionally, the user must acceptresponsibility for any malfunction which mayresult from misuse of any kind or non-compliance with other requirements detailedin this manual.

Worn, broken, distorted, contaminated ormissing components must be replacedimmediately. Should such a repair becomenecessary it is recommended that a requestfor service advice be made to KeomedPLN.

This device and any of its constituent partsmust be repaired only in accordance withwritten instructions issued by themanufacturer and must not be altered ormodified in any way without the writtenapproval of the manufacturer. The user ofthis equipment shall have the soleresponsibility for any malfunction whichresults from improper use, maintenance,repair, damage or alteration by anyone otherthan the manufacturer.

USA and Canadian Federal Law restricts thesale and use of this device to, or on the orderof, a licensed practitioner.

Statements in this manual preceded by thefollowing words are of special significance:

WARNING means there is apossibility of injury to theuser or others.

CAUTION means there is a possibilityof damage to the apparatusor other property.

NOTE indicates points ofparticular interest for moreefficient and convenientoperation.

Always take particular notice of thewarnings, cautions and notes providedthroughout this manual.

USER RESPONSIBILITY

1

1. WARNINGS AND CAUTIONS

The following WARNINGS and CAUTIONSmust be read and understood before usingthis ventilator.

WARNINGSGeneral Information

1. Personnel must make themselvesfamiliar with the contents of thismanual and the machines functionbefore using the ventilator.

Before Using the Ventilator

2. Before the ventilator is used clinicallyfor the first time, verify that the hospitalengineering department has carried outan earth continuity test.

3. Excessive electronic noise caused byother poorly regulated devices, such asan electrocautery unit, may adverselyinterfere with the proper functioning ofthe ventilator.

To avoid this problem, do not connectthe ventilators power cord into thesame electrical wall outlet or adaptorstrip into which an electrocautery unitis connected.

4. If used with a mains extension cord, theunit may be subject to electro-magneticinterference.

5. The driving gas supply must be cleanand dry to prevent ventilatormalfunction.

6. This ventilator is designed to be drivenby oxygen or medical air only. It iscalibrated during manufacture for usewith either gas. Before the ventilator is used clinicallyfor the first time, the commissioningengineer must confirm that the internalAir/Oxygen switch is set correctly forthe gas that is to be used. The use of any other gas will causeinaccurate operation and may damagethe ventilator, resulting in potentialinjury to the patient.

7. The driving gas is discharged throughthe opening in the back of the ventilatorcontrol unit. The discharged gas may contaminatethe environment, and should thereforebe extracted using a gas scavengingsystem.

8. The bellows can only supportapproximately 1 kPa (10 cmH2O)differential positive pressure, abovewhich it may be dislodged from themounting ring, resulting in dangerousmalfunction of the ventilator.

Do not connect a positive endexpiratory pressure (PEEP) valve orother restrictive device to the exhaustport on the bellows base. This would increase the pressure insidethe bellows and the bellows coulddetach from the base, causing seriousmalfunction.

9. Breathing SystemThe breathing system which conveysgases from the anaesthetic machine tothe patient, and disposes of expiredgases, must conform to therequirements of ISO 8835-2.Because breathing systems requirefrequent cleaning and disinfection theyare not a permanent part of theanaesthetic ventilator and thereforecannot be directly under the control ofthe anaesthetic ventilator manufacturer.However, we strongly recommend thatonly breathing systems which havebeen approved and authorised by themanufacturer for use with AV-S shouldbe employed.

Do not use conductive breathingsystem hoses.

When mechanical ventilation isemployed the patient breathing systemmust be connected directly to apressure relief valve to prevent thepossibility of barotrauma.

10. Do not connect a spirometer to theexhaust port on the bellows base. The device will not measure exhaledvolumes in that position.

2

11. The operation of each alarm functionshould be verified daily.

Periodically check the alarms atclinically suitable intervals. If theaudible alarm or the visual indicator ofany alarm function fails to activateduring any alarm condition or fails toreset after the alarm has been cleared,refer the unit to an authorised servicetechnician.

12. Before using the ventilator check thatall connections are correct, and verifythat there are no leaks.

Patient circuit disconnects are a hazardto the patient. Extreme care should betaken to prevent such occurrences.

It is recommended that Safelockfittings are used throughout thebreathing circuit.

13. Check that the cable between thecontrol unit and remote display screenunit is connected before use.Always use a cable type recommendedby the manufacturer.

Using the Ventilator

14. The AV-S ventilator is not intended foruse in intensive care applications.

15. This apparatus must not be used with,or in close proximity to, flammableanaesthetic agents.There is a possible fire or explosionhazard.

16. Anaesthesia apparatus must beconnected to an anaesthetic gasscavenging system (AGSS) to disposeof waste gas and prevent possiblehealth hazards to operating room staff.This requirement must be observedduring test procedures as well asduring use with a patient.The scavenging transfer and receiversystem must conform to ISO 8835-3. Any problem arising from animproperly functioning scavengingsystem is solely the usersresponsibility.Do not use a scavenging system thatrestricts drive gas flow when negativepressure is exerted on it.

17. When the ventilator is connected to apatient, it is recommended that aqualified practitioner is in attendanceat all times to react to an alarm or otherindication of a problem.

18. In compliance with good anaesthesiapractice, an alternative means ofventilation must be available wheneverthe ventilator is in use.

19. It is recommended that the patientoxygen concentration should bemonitored continuously.

20. If the drive gas supply pressure dropsbelow a nominal 241 kPa (35 psi), theLOW DRIVE GAS SUPPLY alarm willactivate both audibly and visually.Patient minute volume may be reduceddue to lowered flow rates

21. An audible alarm indicates ananomalous condition and should nevergo unheeded.

22. The characteristics of the breathingcircuit connected between theventilator and the patient can modify orchange patient ventilation.To assist the maintenance of thedelivered patient tidal volume, theventilator control system softwareincludes:A) a compliance compensationalgorithm,B) a fresh gas compensationalgorithm.

However, patient ventilation must bemonitored independently from theventilator.It is the responsibility of the user tomonitor patient ventilation.

23. Care must be taken to ensure that theflow sensors are connected correctlyto the inspiratory and expiratory portsof the absorber.

24. The Vent Inop (ventilator inoperative)alarm indicates that one of thefollowing conditions has occurred:a) The drive gas solenoid has failed.b) The flow control valve has failed.c) Internal electronic fault.d) Internal electrical fault.e) Software error.

WARNINGS AND CAUTIONS

3

Note that if a ventilator error isdetected, Ventilator Inoperative will bedisplayed on the front control paneldisplay.

25. The High and Low Airway PressureAlarms are important for patient care.It is important that the sensor isproperly located in the expiratory limbof the circuit - refer to section 5.1.10.

26. The patient must be continuouslyattended and monitored whenAdvanced Breathing Modes are in use.

User Maintenance

Control Unit27. Opening the control unit by

unauthorised personnel automaticallyvoids all warranties and specifications.

Prevention of tampering with thecontrol unit is exclusively the usersresponsibility. If the control unit seal isbroken, the manufacturer assumes noliability for any malfunction or failure ofthe ventilator.

28. For continued protection against firehazards, replace the two fuses onlywith the identical type and rating offuse.See section 4 for fuse rating.

29. If the internal battery is fullydischarged, the ventilator will notfunction in the event of mains powerfailure. The battery must be rechargedbefore the ventilator is used clinically,otherwise backup cannot beguaranteed.See Appendix for battery maintenance.See also CAUTION No. 7.

Used or defective batteries must bedisposed of according to hospital,local, state, and federal regulations.

30. No oil, grease or other flammablelubricant or sealant must be used onany part of the ventilator in closeproximity to medical gas distributioncomponents.There is a risk of fire or explosion.

31. Exterior panels must not be removedby unauthorised personnel and theapparatus must not be operated withsuch panels missing.There is a possible electric shockhazard.

Bellows Assembly32. The valve seat on the patient gas

exhalation diaphragm valve in the baseof the bellows assembly must becleaned regularly. Note that the bellowsassembly is built into the A200SPAbsorber - please refer to User Manualfor this product.Failure to keep the valve seat cleancould result in the diaphragm sticking,thus preventing exhalation.

Great care must be taken not todamage the precision surface of thevalve seat on the patient gas exhalationdiaphragm valve in the base of thebellows assembly.

Never use any hard object or abrasivedetergent to clean it; use only a softcloth.If the valve seat is damaged, the valvewill leak and may cause seriousventilator malfunction.

WARNINGS AND CAUTIONS

4

CAUTIONS

1. Do not sterilise the ventilator control unit.The patient block assembly must beremoved from the control unit beforesterilisation ( see section 6.2.5).All other internal components are notcompatible with sterilisation techniquesand damage may result.

2. For ventilator components which requiresterilisation, peak sterilisationtemperatures should not exceed 134oC(275oF) to prevent possible damage.(See section 6).

3. Care must be taken not to let any liquidrun into the control unit; serious damagemay result.

4. The exhalation valve located in thebellows base assembly and the paediatricbellows adaptor must be cleaned andsterilised separately. Note that the bellowsassembly is built into the A200SPAbsorber - please refer to User Manual forthis product.

5. Always check for correct fitment, and carryout a full function test before clinical use, ifthe bellows has been removed andrefitted for any reason. Note that thebellows assembly is built into the A200SPAbsorber - please refer to User Manual forthis product.

6. Always check for correct fitment, and carryout a full function test before clinical use, ifthe bellows has been removed andrefitted for any reason. See section 6.

7. Damage may occur to the battery if it isallowed to remain in a discharged state.Check the battery frequently if theventilator is in storage (see Appendix 1).

8. Fresh gas compensation is disabled if :a) The spirometry system is turned OFFthrough the menu system, or b) The spirometry system is not functioningcorrectly.

9. Fresh gas mixture compensation is disabledif :a) The spirometry system is turned OFFthrough the menu system, or b) The spirometry system is not functioningcorrectly.c) The O2 monitor is switched OFF.

10. Circuit compliance is not activated untilFresh Gas Compensation is switchedOFF.

NOTES

1. The term cycle is used to designate thetransition to the exhalation phase.

2. The term trigger is used to indicate thetransition to the inhalation phase.

WARNINGS AND CAUTIONS

5

Oxygen Monitor

Note that the sensor for the oxygenmonitor is built into the A200SPAbsorber - for additional information,please refer to the A200SP UserManual.

WARNINGS1. We recommend calibration of the

oxygen monitor every time the systemis turned on, as a safety precaution.

2. Do not attempt to open the fuel cell. The sensor contains small quantitiesof :a) electrolyte, classified as a harmfulirritant which is potentially hazardous,and b) lead.

Used or defective cells must bedisposed of according to hospital,local, state, and federal regulations.

3. ALWAYS check the integrity of thesensor assembly before use.

4. Once exhausted, the sensor must bedisposed of according to hospital,local, state and federal regulations.

5. The sensor measures oxygen partialpressure, and its output will rise andfall due to pressure change.An increase in pressure of 10% at thesensor inlet will produce a 10%increase in sensor output.

6. The oxygen sensor is not suitable forsterilisation.If contamination is suspected, fit a newsensor (see section 6.4) and dispose ofthe contaminated unit according tohospital, local, state and federalregulations.

CAUTIONS1. Do not sterilise any oxygen monitor

component.

2. Do not autoclave or expose the sensor tohigh temperatures.

3. If the sensor shows signs of being affectedby condensation, dry the sensor with softtissue.Do not use heat to dry the sensor.

6

NOTES1. The O2 SENSOR FAULT alarm indicates

that one of the following conditions hasoccurred.a) Internal electrical faultb) Software/electronics faultc) Oxygen sensor fault.

2. The concentration read-out may, incertain conditions of excess pressure,show a value above 100%.To accommodate these conditions it ispossible to set the high alarm value up to105% (see section 5).

3. To maintain maximum sensor life:i) always switch off the anaestheticmachine after use, to ensure that the basalflow ceases.ii) disconnect the breathing circuit afteruse.

4. The accuracy of flow and volumemeasurements may be reduced if theoxygen monitor is not in use.

5. Fresh gas mixture compensation is disabledif the oxygen monitor is switched OFF.

WARNINGS AND CAUTIONS - Oxygen Monitor

The AV-S Ventilator is a software controlled,multi-mode ventilator, designed formechanical ventilation of adult andpaediatric patients under generalanaesthesia.In addition, in spontaneous mode, it can beused to monitor spontaneously breathingpatientsIt is designed for use in closed-circuitanaesthesia and also to drive a Mapleson Dcircuit.

Indications for use of the device:

The AV-S Ventilator is intended to providecontinuous mechanical ventilatory supportduring anaesthesia. The ventilator is arestricted medical device intended for use byqualified trained personnel under thedirection of a physician. Specifically theventilator is applicable for adult andpaediatric patients.The ventilator is intended for use by healthcare providers, i.e. Physicians, Nurses andTechnicians with patients during generalanaesthesia.The AV-S ventilator is not intended for use inintensive care applications.

Oxygen Monitor The Oxygen Monitor is intended tocontinuously measure and display theconcentration of oxygen in breathing gasmixtures used in anaesthesia, and isintended for adult and paediatric patients. The oxygen monitor is an integral part of theventilator.The oxygen monitor is intended for use byhealth care providers, i.e. Physicians,Nurses and Technicians for use with patientsduring general anaesthesia.

2. PURPOSE

7

3.1 General Description

The AV-S Ventilator is a pneumaticallydriven, software controlled, multi-modeventilator.

The ventilator is a time-cycled,volume/pressure controlled, and pressurelimited.

The ventilator has compliance compensationand a user selectable option of an inspiratorypause fixed at 25% of the inspiratory time.In addition, fresh gas compensation anduser selectable gas mixture compensation isa standard feature.

Ventilation ModesVolume Mode - continuous mandatoryventilationPressure Mode - pressure controlledventilationSpontaneous, with advanced features -SIMV, SMMV, PSVPEEP

Patient MonitoringAirway pressure, measured from theexpiratory limb of the breathing circuit.

Tidal volume and Minute Volumemeasurement is provided by a dualspirometry system

An integral oxygen monitor systemmeasures oxygen concentration in thebreathing circuit inspiratory limb.

The print function provides a permanentrecord of function activity for up to eighthours during a procedure, or can be used torecord waveforms.

ScreenRemote, arm-mounted, 210 mm (8.4 inch)high definition, colour TFT screen, withsingle/dual waveform display.

3. DESCRIPTION

8

AV-S Ventilator

Bellows unit The bellows unit (1) is built into the A200SPabsorber.A paediatric bellows assembly is available asan option

Drive gas supplyThe supply must be at 310 to 689 kPa (45 to100 psi ).The ventilator drive gas supply can be oxygenor air. Note that the drive gas is specified by thecustomer prior to delivery. Conversion fromone drive gas to another must be carried out bya service engineer trained by the manufacturer.

DESCRIPTION

9

1

10

Control UnitRear Panel

Interface and Parameter inputs5. A200SP Absorber Bag/Vent

switch interfaceSpirometer connector

6. Prima SP2 Interface connector7. Pressure Monitor Port8. Input socket - Oxygen monitor

sensor

Data and Printer Ports9. Data Output10. Output to remote display11. Ethernet12. USB13. VGA14. Printer port15. RS232

NOTEUSB port is for access only by engineerstrained by the manufacturer.All other data ports are read only.For further information, please contactKeomed.

Gas Connections1. Ventilator drive gas inlet

- connect to anaesthetic machineauxiliary gas outlet

2. Bellows Drive Gas Output- connect to bellows via A200SP

absorber - see section 5.1.5)3. Outlet - Exhaust Valve

Electrical Connection4. Electrical mains input and fuse unit

DESCRIPTION

273

13 14 151211109865

41

3.2 Ventilation Cycle

This section provides a simplified description of the ventilation cycle.

1. Inspiratory Phase

The inspiratory proportionalvalve (1) in the control unitopens, and bellows drivegas is delivered to thebellows housing (2).The expiratory proportionalvalve (3) opens and gasflows through the bleedvalve. The back pressureensures that the exhaustvalve (4) is kept closedDrive gas pressure buildsup above the bellows, whichstarts to move down. The diaphragm (5) in thebellows assembly base isheld closed, and patient gasis forced out of the bellowsbase (6) into the breathingsystem.

2. Beginning of Expiratory Phase

The Inspiratory (1) andExpiratory (3) proportionalvalves close and the exhaustvalve (4) opens. Patient gasreturns to the bellows. Asthe bellows rises, redundantdrive gas is pushed outthrough the exhaust valve.

DESCRIPTION

11

1

4

4

5

6

2

3

3

1

31

4

DESCRIPTION

3. End of Expiratory Phase

With the bellows at the topof its housing fresh gascontinues to flow. Toprevent a high pressurebuild up the exhalationdiaphragm (5) lifts andallows gas to exit throughthe exhaust valve (4).

4. PEEPPositive EndExpiratoryPressure(user selectable)

During PEEP the ExhalationProportional valve (3)applies PEEP pressure plus20 cmH2O to the exhaustvalve, which remains closedat this stage.As fresh gas flows in thepatient circuit, any pressureincrease above PEEPpressure in the bellows willcause gas to bleed past theexhaust valve (4). A continuous flow from theInspiratory proportionalvalve (1) ensures that anyfall in pressure iscompensated by driving thebellows as required.

12

5

4

13

DESCRIPTION

A Pneumatic Flow Diagram

C

1817

5

8 14

9

12

6

16

13

1511

7

1

2

10

4

3

B

0 - 80 cmH2O

100 cmH2O

0 - 90 cmH2O

241 kPa (35 psi)

3 to 7 bar

3.3 Pneumatic System3.3.1 System OperationRefer to the pneumatic system diagram on theprevious page.

A) Gas inlet manifold block

The AV-S Ventilator is designed to operate on a310 - 689 kPa (45 -100 psi) drive gas supply(oxygen or air - to customers requirement).

1. DISS ConnectorThe gas source is connected to theDRIVE GAS SUPPLY fitting on the rear ofthe ventilator control unit. The gas supply should be capable of aflow rate of 80 L/min while maintaining aminimum pressure in excess of 310 kPa(45 psi).

2. FilterThe drive gas is filtered with a 40-micronInput Gas Filter which protects thepneumatic components from incomingparticulate matter.

3. The Low Supply Pressure DetectorThe pressure switch is set at apredetermined level to detect a loss orreduction of the input gas sourcepressure. When the pressure falls below 235 kPa(35 psi 1 psi), the LOW SUPPLYPRESSURE indicator will be displayedand the high priority audible alarm willactivate.

4. Input Pressure RegulatorRegulates the input drive gas to 260 kPa 21 kPa (38 psi 3 psi).

5. Cut-off ValveThe valve isolates the the gas supply :a) when the ventilator is switched offb) when a fault condition occurs.

6. Airway Pressure SensorConnected to expiratory limb of breathingcircuit.

DESCRIPTION

14

B) Pneumatic Control Manifold Block

7. Inspiratory Proportional Valve

8. Flow Sensor

9. Drive Gas pressure Sensor

10. Low Pressure Regulator

11. Expiratory Proportional Valve

12. PEEP pressure sensor

13. RestrictorThe restrictor allows a flow of up to 2 L/min(

3.4 Electrical System

Mains SupplyThe mains supply inlet is designed forconnection to any mains voltage from 100 to240 VAC and a frequency of 50 to 60 Hz,without any adjustment. The connector is a standard IEC type.

Back-up BatteryIn the event of mains electrical failure, the back-up battery cuts in automatically.A fully charged battery will power the ventilatorfor approximately 30 minutes.

See Appendix for battery care procedures.

DESCRIPTION

15

Vm SETLitres

3.6

Vm MEASLitres

3.6SETBPM

6Insp Time

Sec

2PEEPcmH2O

5LIMITcmH2O

38

SpontMode

PmeancmH2O10

PmaxcmH2O24

Standby

FreezeWaveform

SMMV %O2 10033 20

TriggercmH2O-1.0

cm H2O

secs

AV-S

Touchscreen control

1

4

3

5

2

Gas MixtureO2 + air ..IOoo

DESCRIPTION

5. Navigator Wheel and Press ButtonTurn the wheel to select a function orparameter, or to alter the value of anactive parameter.Press to confirm the setting.

3.5.1.2 Selecting Functions andParameters

The functions/parameters shown on thescreen can be activated as follows: a) touch the screen at the appropriate tabarea.b) rotate the navigator wheel and press itwhen the indicator arrow is on the requiredparameter tabNote that parameters default to factory-setvalues when the ventilator is switched onand no further user selection is made.

3.5.1.3 User Adjustable ParametersVariable parameters can be altered byrotating the navigator wheel. When the required value is displayed, pressthe active tab or the wheel to confirm thesetting.

3.5 Control Panel

3.5.1 Touchscreen and NavigatorWheel / Push Button

3.5.1.1 Control Panel

1. On/Off controlSwitch On:Short internal test sequenceSwitch Off:Power down sequence with progressindicator

2. Status indicators for electrical power(mains/battery supply)

Yellow indicator - illuminated wheneverpower is applied to the unit and internalbattery is being chargedGreen indicator - illuminates when theunit is switched on

3. Menu switchThe menu function provides access touser and service pages

4. Alarm mute switch30 second or 120 second alarmsilence, depending on alarm status.Note also that some alarms are notmutable (see 3.11).

16

3.5.2 User Adjustable Parameters

Tidal Volume Range 20-1600 ml

Rate 4-100 bpm

I:E Ratio 1:0.3 to 1:8

PEEP 4-30 cmH2OCan be set to OFF

Pressure LimitVolume mode: 10-80 cmH2OPressure mode: 10-70 cmH2O

3.5.3 Operational CapabilityTidal Volume, Rate, and I:E ratio settings are all limited by amaximum inspiratory flow of 75 L/min.

DESCRIPTION

17

0.1

0.2

0.4

0.3

0.6

0.5

1.6

1.5

1.4

1.3

1.2

1.1

1.0

0.9

0.8

0.7

0 10 20 30 40 50 60 70 80

1:6 1:5 1:4 1:3 1:2 1:1 1:0.3

Rate (bpm)

TidalVolume(litres)(Vt)

I:E Ratio

The ventilator is capable of operating at the volumes and rates below each I:E ratio curve.

Example1. Select required volume (Vt) (e.g. 0.8 L)2. Select rate (e.g. 10 bpm).3. Select I:E ratio of 1:2.

The point X on the graph lies beneath the 1:2 ratio curve, and is therefore within the ventilators capability.

X

3.5.4 Output CompensationFunctions

WARNINGThe AV-S automatically compensates for freshgas (spirometry On), fresh gas mixture(spirometry and oxygen monitor On), andaltitude. However, the actual tidal volume delivered to thepatient may be different to the ventilationparameters set by the user, due to:A) an extreme compliance condition,B) a substantial system leak, C) patient circuit pressure effects, orD) extreme fresh gas flows

In addition, high fresh gas flows will lead to anincreased Vt being delivered to the patient. The patient must be monitored independentlyfrom the ventilator.It is the responsibility of the user to monitor thepatient for adequate ventilation.

Fresh Gas CompensationAdjusts delivered volume up to 60%Alarms if measured volume is 50% differentthan set volumeUser adjustable

NOTEFresh gas compensation is disabled if :a) The spirometry system is turned OFF through themenu system, or b) The spirometry system is not functioning correctly.

Fresh Gas Mixture Compensation - models with SpirometryThe spirometry system compensates for fresh gasmixture - the user must access the menu system andselect the gas mixture that will be used for eachclinical procedure.

NOTEFresh gas mixture compensation is disabled if :a) The spirometry system is turned OFF through themenu system, or b) The spirometry system is not functioning correctly.

If the O2 monitor is switched OFF, a 40% / 60%mixture of O2/N2O is assumed.

Altitude CompensationMonitors ambient pressureAdjusts delivered volume accordinglyNOTE Altitude compensation is automaticallyapplied during calibration of the oxygen monitor - seesection 5.3.2.

DESCRIPTION

18

AB

3.6 Interface to Prima SP2/3 and A200SPThe AV-S is designed to interface with the PrimaSP2 Anaesthetic Machine and the A200SPAbsorber.

3.6.1 Prima SP2 Interface

The interface cable links the socket (A) on thecontrol panel to a socket on the rear panel of theanaesthetic machine.

a) Turn the anaesthetic machine Gas DeliverySwitch to ON. The ventilator will power-up.

b) While the anaesthetic machine power is ON,the Ventilator can be turned OFF and ON,using the ventilator On/Off switch, asdescribed in section 3.5.1.

c) Turn the anaesthetic machine Gas DeliverySwitch to OFF. The ventilator will power-down.

3.6.2 A200SP Absorber InterfaceThe interface cable links the socket (B) on thecontrol panel to a socket (C) at the rear of theabsorber.

a) The A200SP is fitted with fitted with a sensorthat detects the position of the absorberbag/vent control (D).The sensor signal cabling is routed internallyto connector (C) and a second cable runs tothe the rear of the AV-S control unit.

b) Operation of the Bag/Vent control will triggerautomatic Mode switching on the AV-Sventilator, as follows:i) If the Absorber Bag/Vent control is movedfrom Vent to Bag, the ventilator will changefrom Volume Mode, or Pressure Mode, intoSpontaneous Mode.ii) Switching the absorber Bag/Vent controlfrom Bag to Vent:The ventilator will reset from SpontaneousMode to the previously set active mode.iii) If the ventilator is in any mode other thanthose detailed above, operation of theabsorber Bag/Vent control will not affect theventilator.NOTE This function can be enabled/disabledthrough the AV-S on-screen menus (Service Sub-menu, see appendix).

19

DESCRIPTION

D

C

3.7 Ventilation Modes

3.7.1 Standby Mode

Allows parameters to be set.

Some patient alarms are active:High airway pressure (at 80 cmH2O)High/Low O2Negative pressureIncorrect Rate/Ratio

DESCRIPTION

20

3.7.2 Volume Mode

The ventilator delivers a mandatory setvolume of gas at preset, fixed breathintervals.The Patient is making no respiratory effort.

3.7.2.1 Fresh Gas CompensationAdjusts delivered volume up to 60%This delivered volume will consist of thevolume delivered from the ventilator bellowsplus the fresh gas flow from the anaestheticmachine fresh gas supply, minus anycompliance loss and minus any leak. This gives a total actual inspired tidalvolume.An alarm is triggered if measured volume is50% different than set volumeUser adjustable

Altitude CompensationMonitors ambient pressureAdjusts delivered volume accordingly

3.7.2.2 Operating FunctionsInspiratory. Pause function:Creates 25% plateau

Sigh function:When the ventilator is in Volume Cyclemode the "sigh" option is available. Whenselected, this option provides extra volumefor 1 to 4 breaths in 50 (frequency is userselectable). The extra volume will be 50% above thetidal volume set by the user.

Volumes measured if Spirometry functionselected

Auto High and Low volume alarms ifmeasured volume different by 50% of setvolumeUser adjustable option

If max pressure limit achieved, ventilatorcycles to expiratory phase

3.7.2.3 Volume Type SelectionUse the menu to switch between TidalVolume and Minute Volume.NOTE Minute Volume is derived from a rollingaverage during a 30 second period.

Volume Mode Parameters

Tidal volume 20-1600 mLRate 4-100 bpmI:E ratio 1:0.3-1:8PEEP 'Off' or adjustable 4-30 cmH2OInspiratory pressure limit 10 to 80 cmH2OInspiratory pause 25%(does not affect I:E ratio)Sigh 1.5 x Set Vt is

delivered once, twice,three times or fourtimes every 50breaths (user selectsfrequency)

DESCRIPTION

21

3.7.3 Pressure Mode

3.7.3.1 ParametersThe ventilator delivers a volume of gas toachieve a set pressure at fixed breathintervals.The Patient is making no respiratory effort.This is a common mode for the ventilation ofsmall paediatric patients.

Inspiratory pressure 10-70 cmH2ORate 4-100 bpmI:E ratio 1:0.3 - 1:8PEEP 'Off' or adjustable: 4-30 cmH2O

Inspiratory decelerating flow controlled by theventilator according to pressure settingNo Inspiratory pause function

3.7.3.2 Pressure Mode Operating FunctionsDefaults to 10 cmH2OMaximum Inspiratory Flow to achieve targetpressureSustaining flow maintains circuit pressureControl achieved using exhaust valve

DESCRIPTION

22

DESCRIPTION

23

3.7.4 Spontaneous Mode

3.7.4.1 ParametersThe ventilator monitors the following patient parameters:

RateI:E ratioPressureTidal volume

Provides waveform displays

Inspiratory oxygen is measured

3.7.4.2 Spontaneous Mode Operating Functions

No mechanical ventilationNo Inspiratory Pause function

Patient Monitoring (Bag mode and Ventilator mode):Airway pressuresFiO2, Vt, Rate I:E ratio, Supply pressuresVentilation conditions

Patient support modes are selectable from this mode - seebelow

3.7.4.3 Patient Support Modes

Support modes available from 'Special Modes' menu:SIMV - Synchronised Intermittent Mandatory VentilationSMMV - Synchronised Mandatory Minute VentilationPSV - Pressure Supported Ventilation

CAUTIONThe required patient support mode must be pre-selected inStandby Mode (select from main menu), before it can beactivated during the ventilation of a patient. Please refer to sections 3.7.5.1, 3.7.5.2, 3.7.5.3.

The A100SP Absorber Bag/Vent switch must be in 'Vent'position for these modes to be selected.

Note that if the system fails to detect an absorber bag/ventswitch, a confirm message will be displayed.

24

DESCRIPTION

3.7.5 Advanced Spontaneous Breathing Modes

3.7.5.1 SIMVSynchronised Intermittent Mandatory Ventilation

Guarantees a minimum level of volume. SIMV allows spontaneous breaths and a setmandatory breath

Pre-selection in Standby ModeSelect StandbySelect MenuSelect Special Modes Select Support ModeSelect SIMVEscape Menu

SIMV will now be displayed on the mainscreen in Spontaneous mode.

NOTE1. The trigger window is pre-set to 60% of

the BPM cycle time.2. The trigger pressure is PEEP

referenced3. If Spirometry is disabled then SIMV is

not available4. If the pressure limit and alarm are

activated the inspiratory phase isterminated

Selection during Ventilation1. Move the absorber Bag/vent switch to

BagThe ventilator will switch toSpontaneous Mode.

2. Select Special Mode on the display.A message will appear:Confirm Vent Mode SettingNote that this refers to the absorberBag/Vent switch position.

3. Press the navigator wheel / pushbutton to confirm.

4. Move the absorber Bag/vent switch toVentilator.

5. Check that SIMV is functioningcorrectly.

SIMV Default SettingsThe ventilator will default to pre-set valuesfor Vt, Rate, Inspiratory Time and TriggerLevel, after selecting 'SIMV'.

Note:1. Vt can be adjusted before SIMV is

confirmed.2. Trigger setting is adjustable between

0.2 and 1.0 L/min.

PEEP

0 cmH2O

Pmax

A

SIMV - Spontaneously Breathing PatientA = Cycle Time (set from BPM)B = Trigger WindowC = Spontaneous BreathD = TriggerE = Mandatory breath at the set Vt

Inspiratory flow in the Trigger Window (generated by thepatients spontaneous breath) results in a synchronisedmandatory breath at a preset volume and rate

SIMV - No breathing effort by PatientA = Cycle Time (set from BPM)B = Trigger WindowC = Flat Pressure Trace (no breathing effort)D = Mandatory breath at the end of the Trigger Window at the set Vt

If the patient makes no effort to breathe during a cycle, amandatory breath, at the end of the trigger window, will still bedelivered at the preset volume and rate.

A

BB

C

D

E

PEEP

0 cmH2O

Pmax

A A

BB

CD

25

DESCRIPTION

3.7.5.2 SMMVSynchronised Mandatory

Minute Ventilation

Guarantees a set level of minute volumeventilation. SMMV allows spontaneousbreaths, combined with a synchronisedmandatory breath, to achieve the setminute volume

Pre-selection in Standby ModeSelect StandbySelect MenuSelect Special Modes Select Support ModeSelect SMMVEscape Menu

SMMV will now be displayed on the mainscreen in Spontaneous mode.

NOTE1. The trigger window is pre-set to 60% of

the BPM cycle time.2. The trigger pressure is PEEP

referenced3. If the Spirometry is disabled then

SMMV is not available4. If the pressure limit and alarm are

activated the inspiratory phase isterminated.

Selection during Ventilation1. Move the absorber Bag/vent switch to

BagThe ventilator will switch toSpontaneous Mode.

2. Select Special Mode on the display.A message will appear:Confirm Vent Mode SettingNote that this refers to the absorberBag/Vent switch position.

3. Press the navigator wheel / pushbutton to confirm.

4. Move the absorber Bag/Vent switch toVentilator.

5. Check that SMMV is functioningcorrectly.

SMMV Default Settings

The ventilator will default to pre-set valuesfor Vm, Rate, Inspiratory Time and TriggerLevel, after selecting 'SMMV'.

Note:1. Vm can be adjusted before SMMV is

confirmed.2. Trigger setting is adjustable between

0.2 and 1.0 L/min.

PEEP

0 cmH2O

Pmax

A

SMMV - Spontaneously Breathing PatientA = Cycle Time (set from BPM)B = Trigger WindowC = Spontaneous BreathD = TriggerE = Vt of Mandatory Breath is equal to Vm / BPM minus the volumespontaneously breathed during the cycle (maintaining the set Vm)

Inspiratory flow in the Trigger Window (generated by thepatients spontaneous breath) results in a synchronisedmandatory breath, ensuring that the set minute volume isachieved

A

BB

C

D

E

PEEP

0 cmH2O

Pmax

A

SMMV - No breathing effort by PatientA = Cycle Time (set from BPM)B = Trigger WindowC = Flat Pressure Trace (no breathing effort)D = Mandatory breath at the end of the Trigger Window at the set Vm

If the patient makes no effort to breathe during a cycle, amandatory breath, at the end of the trigger window, will still bedelivered at the preset volume and rate

A

BB

C

D

DESCRIPTION

26

3.7.5.3 PSVPressure SupportedVentilation

PSV assists each spontaneous breath toachieve a preset pressure, thus reducingthe effort required to breathe.Inspiratory flow (generated by the patientsspontaneous breath) results insynchronised pressure support.

Pre-selection in Standby modeSelect Standby ModeSelect MenuSelect Special ModesSelect Support Mode Select PSVEscape Menu

PSV will now be displayed on the mainscreen in Spontaneous mode.

Selection during Ventilation1. Move the absorber Bag/vent switch to

BagThe ventilator will switch toSpontaneous Mode.

2. Select Special Mode on the display.A message will appear:Confirm Vent Mode SettingNote that this refers to the absorberBag/Vent switch position.

3. Press the navigator wheel / pushbutton to confirm.

4. Move the absorber Bag/Vent switch toVentilator.

5. Check that PSV is functioningcorrectly.

NOTE1. The trigger window is pre-set to 60% of

the BPM cycle time.2. The trigger pressure is PEEP referenced.3. If the Spirometry is disabled then PSV is

not available.4. If the pressure limit and alarm are

activated the inspiratory phase isterminated.

PSV Default SettingsThe ventilator will default to pre-set valuesfor Support Pressure, Inspiratory Time, andTrigger Level after selecting 'PSV' .

Note:1. Support Pressure can be adjusted

before PSV is confirmed.2. Trigger setting is adjustable between

0.2 and 1.0 L/min.

PEEP

0 cmH2OA

PSV Pressure Supported VentilationA = Set Inspiratory TimeB = Pressure Support LevelC = Spontaneous Breath results in a synchronised pressure supported breath

PSV is used to support spontaneously breathing patients ONLYIf the patient makes no attempt to breathe, the ventilator will not providesupport and the apnoea alarm will be activated

A

B

C C

3.7.5.4 PEEP ( Positive End Expiratory Pressure)

The AV-S ventilator includes a microprocessor-controlled, electronically integrated PEEP system,regulated using secondary pressure on the exhaustdiaphragm.

The ventilator controls PEEP by allowing flow from, ordelivering flow into the bellows drive circuit, maintainingpressure

PEEP is electronically controlled Variable from 4-30 cmH2O in increments of 1 cmH2OClear OFF indication when not in useSwitch off the ventilator - PEEP is switched off.PEEP is switched off during 'Spont' mode to minimise patientsbreathing effort.

Selecting PEEPSelect by touching the screen tab PEEP, or using thenavigator wheel The setting will flash.

Rotate the navigator wheel to set the required PEEPpressure.A confirm message will be displayed. Press the Screen Tab, or Wheel to confirm.

Note that Electronic PEEP does not function inSpontaneous Mode.

PEEP on/off sequenceUsing the A200SP Absorber Interface - VentilatorMode Selection

1. Ventilator is in Volume Ventilation Mode

2. PEEP selected, pressure set to required level.PEEP display indicates pressure

3. A200SP Absorber Bag/Vent control (A) is movedto Bag position.Ventilator automatically switches to SpontaneousMode.PEEP is automatically switched off (does notfunction in Spontaneous Mode)PEEP display is blank.

4. Bag/Vent control reset to Vent position.Ventilator automatically switches to the modepreviously set by the user.PEEP is Off.PEEP display indicates Off.

5. Set ventilator to Volume Ventilation Mode.PEEP remains Off.Select PEEP if required.

DESCRIPTION

27

A

DESCRIPTION

3.8 On-Screen Menus

To Access:Press the menu switch on the front panel toaccess the following functions and parametersvia drop-down menus:

EXIT MENUSO2 MONITOR & SPIROMETRYFRESH GAS COMPENSATION: ONSPECIAL MODESWAVEFORMALARM SETTINGSGAS MIXTURE: O2+AIRUSER SETTINGSSERVICE MENU

To Exit:Press the menu switch on the front panel, or,select EXIT MENUS and press the wheel.

NOTEThe menu window will not be displayed if:A) Control parameters (VT MEAS, BPM, I:E, PEEP,

or LIMIT) are enabled but not confirmed.B) A display window is active

To Operate:1. Rotate the navigator wheel clockwise to

scroll through the menu options - thecursor ( > ) aligns with each parameter inturn.

2. Press the wheel to enter the required sub-menu.

3. Rotate the navigator wheel to change anydisplayed values, and press to confirm.

4. To exit the menu display:A) Press the menu switch on the frontpanel .B) Scroll to EXIT MENUSand press the navigator wheel.

NOTEA) If confirmation does not take place within 8

seconds, the parameter reverts to its previousvalue.

B) If another parameter is selected using thetouchscreen, the menu is de-selected.

C) While any menu is selected:- the alarms are active,- the ventilator can be switched off.

See Appendix 2 for a full description of theMenu system.

Menu Switch

28

Turn the wheelto scroll throughthe menus.Press to entersub-menu

3.9 Spirometry

Spirometry can be enabled, or disabled via theon-screen menu system. NOTEIf the spirometry system is turned OFF:a) Fresh gas / fresh gas mixture compensationis disabled.b) Special Modes are disabled.

See Appendix 3, for a detailed description of thespirometry system.

3.10 Display Waveforms

Default waveform is always Pressure v Time(cmH2O v seconds)

Wave Freeze is available when ventilation is inprogress.

Second waveform A second waveform can be displayed by usingmenu control or touch waveform on screen.

The second waveform is selectable:Volume v Time (litres v seconds)Volume v Pressure (litres v cmH2O)Compliance loop waveform- First loop can be frozen- Subsequent loops overlaid

Display Functions

Automatic Scale adjustment

Y axisa) Scale adjusts as Plimit is changed

(-20 to 40, 60, 80 cmH2O)

b) In Vol. v Time mode as Vt is changed (0 to 0.5 L, 1.0 L, 2.0 L)

X axisa) Scale adjusts as Rate is changed

0 to 15 sec, 5 sec, 3 sec

b) In Vol. v Pres. mode as Plimit is changed(-20 to 40, 60, 80 cmH2O)

DESCRIPTION

29

DESCRIPTIONA

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3.11 Alarms

DESCRIPTION - O2 Monitor

3.12 Oxygen Monitor

The oxygen monitor continuously measures and indicatesthe concentration of oxygen in the breathing system, andtriggers an alarm when the concentration varies from theset levels.3.12.1 System DescriptionThe Oxygen Monitor uses a fast-responding, oxygen-specific, self powered sensor that achieves 90% of finalvalue in less than 10 seconds.

An external probe (1) is supplied with a 2 m (6 ft)extendable cable.

The system has user-adjustable high-level and low-levelalarms with visual and audible indication of alarmconditions.

Bacterial Filter Use a breathing system bacterial filter in theexpiratory limb of the breathing circuit to protect theoxygen sensor (see section 5).CAUTIONReplacement/Disposal - always follow the instructionssupplied with the filter, and always replace at therecommended interval.

3.12.2 The MOX-3 Oxygen SensorThe MOX-3 oxygen sensor offers quick response, linearoutput over the entire 0-100% oxygen range, and longservice life.

The MOX-3 is a self-powered galvanic cell that generatesa current proportional to oxygen concentration.

The cell has a highly stable output over its operating life.Significant output loss is only shown at the very end of itslife. Typical sensor drift rates are less than 1% per month whenthe sensor is exposed to gas in typical applications.

Sensor life:approximately 1500000 O2 percent hours at 20oC(minimum one year in most normal applications).

Sensor lifetime is governed by the mass of lead availableto react with the oxygen and its rate of consumption. Highoxygen partial pressure and high temperature will increasethe sensor output current, thus shortening the operationlife.

At the point where all lead has been consumed, the outputwill fall very quickly to zero over a period of two to threeweeks.

31

O2 Sensor LocationPrima SP with A200SP Absorber

1

3.12.3 O2 Monitor sub-menu

ON/OFFTurn the navigator wheel to switch betweenON and OFF.Press to confirm.Scroll to EXIT MENUS and press the wheelto exit.

NOTEThe oxygen monitor automatically switches ONand defaults to the previous values for high andlow alarm settings when the ventilator isswitched on.Fresh gas mixture compensation is disabled if theO2 monitor is switched OFF.

CALIBRATIONPress the navigator wheel to initiate thecalibration procedure (see section 5.3.2 forfull procedure).To exit the menu, scroll to EXIT MENUSand press the wheel.

HIGH ALARM SETLOW ALARM SETScroll to the required parameter and pressthe navigator wheel to activate.Rotate the navigator wheel again to changethe displayed value.(see section 5.3.4 for full procedure).

High Alarm range: 19% to 105%Low Alarm range 18% to 99%

The displayed figure will flash on and off.Press to confirm. Scroll to EXIT MENUS and press the wheelto exit.

O2 Monitor sub-menu

O2 Monitor sub-menu - calibration

O2 Monitor sub-menu - alarms

DESCRIPTION

32

O2 Monitor & Spiro

ESCAPE FROM MENU> O2 MONITOR: on

CALIBRATION: 100%HIGH ALARM SET: 105LOW ALARM SET: 18SPIROMETER: onSPIRO CALIBRATION: 0 L/min

O2 Monitor & Spiro

ESCAPE FROM MENUO2 MONITOR: on

> CALIBRATION: 100%HIGH ALARM SET: 105LOW ALARM SET: 18SPIROMETER: onSPIRO CALIBRATION: 0 L/min

O2 Monitor & Spiro

ESCAPE FROM MENUO2 MONITOR: onCALIBRATION: 100%

> HIGH ALARM SET: 105LOW ALARM SET: 18SPIROMETER: onSPIRO CALIBRATION: 0 L/min

DESCRIPTION - O2 Monitor

3.12.4 DisplayHigh-set, low-set, and oxygen concentrationpercentage readings are displayed on screen.Touch the tab to activate O2 menu

Oxygen ConcentrationThe display provides a direct readout ofmeasured oxygen concentrations in the range0-100%.

Low Alarm Set - limited within 18-99%The oxygen percentage, set by the user, atwhich the low alarm will be activated. To set the low oxygen alarm, see section 5.3.4.

High Alarm Set - limited within 19-105% The oxygen percentage, set by the user, whichthe high alarm will be activated. Note that in certain conditions of excesspressure, the readout may show a value above100%. To set the high alarm, see section 5.3.4.

3.12.5 Display

HIGH O2 ALARMThe high O2 alarm is triggered when the oxygenconcentration is 1% above the set value.

a) The High O2 Alarm visual indicator willilluminate.

b) A high priority audible alarm will sound.

To cancel this alarm, the high alarm setting mustbe equal to, or above the oxygen concentration. The alarm can be muted for 120 seconds.

LOW O2 ALARMThe low alarm is triggered when the oxygenconcentration is 1% below the set value.

a) The Low O2 Alarm visual indicator willilluminate.

b) A high priority audible alarm will sound.

To cancel this alarm, the low alarm setting mustbe equal to, or below the oxygen concentration. The alarm can be muted for 120 seconds.

O2 SENSOR FAULTThe alarm is triggered:

i) when either the oxygen sensor isdisconnected or approaching the end of its life.

ii) if the O2 concentration exceeds 110%.

a) The message O2 SENSOR FAULT will bedisplayed.

b) A high priority audible alarm will sound.

To cancel this alarm, check the sensorconnection or replace the sensor.The alarm can be muted for 120 seconds.

O2 SENSOR LOWThis alarm indicates the sensor has approachedthe end of its life. The legend O2 SENSOR LOW will be displayed,and a low priority alarm (single note) will sound.

The sensor must be replaced as the output willfall very quickly to zero within two to three weeksof normal usage.See section 6.5 for sensor replacement.

3.12.6 Oxygen Monitor Alarm MuteIn an alarm condition, pressing the ALARMMUTE button will deactivate the audible alarm,but the alarm message display will remain onscreen. The switch will illuminate, and a single note willsound.

The alarm mute can not be operated:

a) Until the mute time is over, or the alarmcondition has been rectified.

b) When O2 concentration drops below 18%.

Measured O2concentration

High Alarm SetValue

Low Alarm SetValue

33

%O2 10033 20

..IOoo

4.1 Application Ventilation for use in anaesthesia.

4.2 Internal ComplianceAdult bellows 3 ml/cmH2O (nominal)Paediatric bellows 2 ml/cmH2O (nominal)

4.3 PhysicalSize (mm)

- control unit only 290 wide x 300 deep x 185 high- with adult bellows 290 wide x 300 deep x 385 high

Screen Size 210 mm (8.4") TFTWeight - control unit only 7.6 kg

- with adult bellows 9 kgBellowsAdult (Latex free): 20 ml - 1600 mlPaediatric : 20 - 350 ml(Note - latex free paediatric available as option)

Power 90 - 264 VAC, 47 - 63 HzBattery Back-up: 30 minutes (assumes fully charged battery)Drive Gas Oxygen or Air

(dry, and oil free) at 45 to 100 psi (310 to 689 kPa).

4.4 AlarmsAlarm Mute 30 or 120 seconds (see 3.11)Low Drive Gas Pressure Less than 235 kPa (35 psi)High Continuous Airway Pressure Above 30 cmH2O at start of cycleLow Pressure 4 - 14 cmH2O PEEP referencedLow Tidal Volume 50% of Volume set (Spirometry)Incorrect Rate or RatioMains Failure 30 minutes (nominal) Battery BackupLow Battery 5 minutes UseVentilator Inoperative Internal or Battery FailureOutlet Blocked Exhaust valve outlet blocked

Alarms - User SetVt (Tidal)

Min 0 - 1600 mlMax 20 - 1600 ml

Vm (Minute) Min 0 - 10 L

Max 0 - 30 L

Apnoea Adjustable Re-set Pressure (Time referenced)

Low and High O2 Concentration 18% - 105%

High Airway Pressure 10 - 80 cmH2O adjustable

4. SPECIFICATION

34

4.5 Functional

Tidal VolumeAdult bellows 20 to 1600 ml (10%)Paediatric bellows 20 to 350 ml (10%)

At ambient temperature of 20oC (+/-10%) and ambient atmosphere of 101.3 kPa (+/-10%).

Minute Volume 0 to 30 LRate 4 - 100 bpm I:E Ratio 1:0.3 - 1:8Pressure Limit 10 - 80 cmH2OFresh Gas Compensation Automatic Tidal Volume adjustment

Modes OffStandby Volume CyclePressure ControlledSpontaneous (includes advanced breathing modes)

Pressure Control 10 - 70 cmH2OInspiratory Flow 2 - 75 L/min

Spontaneous Mode Active Volume and Pressure Alarms, Advanced Breathing Modes selectable (see section 4.6)

Electronic PEEP 4 - 30 cmH2O

Oxygen Monitor Fuel Cell typeFor full specification, see section 4.15.

Spirometry - Resolution 1 ml

Ventilator Performance - accuracy of delivered volumes>300 ml 10%>100 ml

4.6 Advanced Spontaneous Breathing Modes (SIMV, SMMV, PSV)Trigger (PEEP Referenced) 0.2 to 4 L/minTrigger Window Set 60% of Expiratory TimeVt and Vm As Volume ModeInsp Time (Ti) 0.5 to 5 secsSupport Pressure 3 to 20 cmH2O

Default settings

Volume Vt BPM I:E PmaxAdult 600 ml 10 1:2 38 cmH2OPaediatric 150 ml 15 1:2 38 cmH2O

Pressure Vt BPM I:E P-targetAdult 600 ml 10 1:2 10 cmH2OPaediatric 150 ml 15 1:2 10 cmH2O

SIMV Vt BPM Insp time TriggerAdult 600 ml 6 2 sec 0.4 L/minPaediatric 200 ml 10 1 sec 0.4 L/minSMMV Vm BPM Insp time TriggerAdult 3.6 L 6 2 sec 0.4 L/minPaediatric 2 L 10 1 sec 0.4 L/minPSV Support Pressure Insp timeAdult 10 cmH2O 0.4 L/minPaediatric 10 cmH2O 0.4 L/min

4.7 Disinfection and Sterilisation Patient Block assembly can be sterilised ifnecessary - section 6.Bellows assembly, oxygen monitor sensor, andspirometer sensors - Note that these components arebuilt into the A200SP Absorber - please refer to theUser Manual for this product.

4.8 Bacterial Filter None (see section 5.1.4, use a bacterial filter inthe breathing system to protect the oxygensensor)

4.9 Fail Safe Mechanism Battery back-up in case of mains electricityfailureGas shut-off in the event of electronic failure

4.10 Reliability MTBF: 5x106 to 50x106 cycles 4.11 Waveform Tests Not applicable 4.12 Volume Tests Not applicable

4.13 Mobility and Mounting

(A) Mobility Secure mounting required (B) Mounting Control unit and remote screen are mounted on

anaesthetic machine .The bellows assembly is built into the A200SPAbsorber.

4.14 Fuse (mains supply) Two fuses, Type T 2AH2 A, 250 V rating, 20 mm, anti surge, ceramic.

SPECIFICATION

36

4.15 Oxygen Monitor

Measurement Range: 0-l00%Resolution: 1%

Accuracy and Linearity: 2% of full scale (at constant temperature and pressure)Response Time: 90% of final value in approx. 10 seconds (air to 100% O2)

Operating Temperature: 50F to 100F (10C to 38C)Storage Temperature: 23F to 122F (-5C to 50C)Relative Humidity Range: 5%-95% (non-condensing)

Battery Back-up: As per ventilator

High Priority Alarm: Flashing, 5 audio pulses with 6 seconds repeat time.Medium Priority Alarm: Flashing, 3 audio pulses with 24 seconds repeat timeLow Priority Alarm: Static with single beep soundAlarm Mute: 30 seconds for high priority alarm

120 seconds for medium priority alarm

Low Alarm Set Range: 18%-99% ( 1%)High Alarm Set Range: 19%-105% ( 1%)

Cable length: 2 m (6 ft), fully extended

Sensor Type: MOX-3 Galvanic fuel cell sensor (0-100%)Life: 1500000 O2% hours

(One year minimum in typical applications)

Interference Gases and Vapours (in 30% Oxygen, 70% Nitrous Oxide)

Interference Volume % Dry Interference in O2%

Nitrous Oxide 80%

Oxygen Monitor - continued

Humidity EffectsSensor output is relatively unaffected by prolonged operation in either high or very low relativehumidity.If the sensor shows signs of being affected by condensation, dry the sensor with soft tissue.CAUTION DO NOT use heat to dry the sensor.

Temperature EffectsThe sensor has a built-in temperature compensation circuit, and is relatively unaffected bytemperature changes within the operating temperature range given above.

Pressure Effects The sensor measures O2 partial pressure, and its output will rise and fall due to pressure change(e.g. changes in barometric pressure, or breathing system pressure).An increase in pressure of 10% at the sensor inlet will produce a 10% increase in sensor output.

NOTEAltitude compensation is automatically applied during calibration.

SPECIFICATION - O2 Monitor

38

5. PRE-OPERATION PROCEDURES

5.1 Ventilator Set-up

5.1.1 Mounting the Ventilator

The remote screen is mounted on anadjustable arm, with the control unitmounted at the rear or side of theanaesthetic machine.

Option control unit location Preferably, mount it permanently on the shelfof the anaesthesia machine or on a strongbracket. This will protect the ventilator fromaccidental fall and disconnection of thehoses. To fit the ventilator control unit permanentlyon a mounting bracket:1. Align the four mounting feet over the

mating holes in the bracket.2. Use the four M4 screws supplied with

the mounting bracket kit, insertedthrough the bracket and rubber feetand screwed into the threaded insertsin the base of the ventilator.Only use the screws supplied withthe kit.

Pole-mount type mounting brackets and sideframe brackets are available from themanufacturer.

Bellows unit The bellows unit is built into the A200SPabsorber.

5.1.2 Electrical Power Connection

Before connecting the ventilator to the mainssupply, check that the power supply is withinthe correct rating as stated on the label onthe rear of the control unit.

WARNINGExcessive electronic noise caused by other,poorly regulated devices, such aselectrocautery, may adversely interfere withthe proper functioning of the ventilator.To avoid this problem, do not connect theventilator power cord into the same electricalwall outlet or strip into which anelectrocautery unit is connected.

5.1.3 Ventilator Gas Supply

1. Verify the drive gas specified for theventilator (oxygen or air).Always use the correct drive gas.

2. Connect the drive gas inlet port on therear of the control unit to a dry, oil freesupply.

Supply pressure range:45 to 100 psi (3.1-6.9 bar, 310-689 kPa)

OXYGEN SUPPLY: a) O2 cylinder,b) Anaesthetic machine O2 auxiliary gasoutlet, c) O2 pipeline supply from a wall outlet.

AIR SUPPLY:a) Air cylinder, b) Anaesthetic machine Air auxiliary gasoutletc) Air pipeline supply from a wall outlet.

Supply pressure should be monitoredby a separate means, e.g. pressuregauge on anaesthetic machine orsupply line.

NOTE: It is possible to reconfigure theventilator for use with a different drive gasto the gas originally specified. This workmust be carried out by an engineer trainedby the manufacturer.

5.1.4 Breathing System Schematic

The following page contains a schematicdiagram showing the cables and tubing for anAV-S ventilator mounted on a Prima SP2anaesthetic machine with an integral A200SPAbsorber.

39

Note1. AV-S has spirometry and oxygen monitor.2. Interface cabling is shown for Prima SP2

On/Off switch and A200SP Bag/Ventswitch.

40

Hoses and Cables SchematicAV-S and A200SP Absorber

PRE-OPERATION PROCEDURES

1

23

6

78

12

131614

261715

12

19

18

2024

2523

28

27

29

31

30

26

21

22

9

1011

4

5

PRE-OPERATION PROCEDURES

41

1. Bellows2. Ventilator Control Unit3. Outlets to Anaesthetic Gas Scavenging System (AGSS)4. Bacterial Filter5. Absorber valve block6. Heat and moisture exchanger7. Patient8. CGO Block on anaesthetic machine (Fresh Gas Supply)9. Auxiliary Outlet on anaesthetic machine (Drive Gas Supply)10. Flow sensor - expiratory11. Flow sensor - inspiratory12 Connectors - sensor - pressure monitor13. Expiratory Valve - Absorber14. Inspiratory Valve - Absorber15. Inlet - from Ventilator Bellows16. Connector - Reservoir Bag17. Inlet - Absorber - Fresh Gas Supply18. Drive Gas Inlet - Ventilator19. Drive gas Outlet - ventilator control unit to bellows20. Outlet - Exhaust Valve21. Inlet - Bellows Drive Gas22. Outlet - to breathing system23. Input socket - Oxygen monitor sensor24. Input socket - Prima SP interface

(SP on/off switch)25. Input socket:

(i) A200SP Absorber Bag/Vent control position(ii) Spirometer sensor signal

26. Interface connections on Prima SP2 and A200SP27. APL Valve28. Outlet from APL Valve to AGSS29. Oxygen sensor30. Remote screen unit31. Cable - control unit to screen

PRE-OPERATION PROCEDURES

42

273

13 14 151211109865

41

Control UnitRear Panel

Interface and Parameter inputs5. A200SP Absorber Bag/Vent

switch interfaceSpirometer connector

6. Prima SP2 Interface connector7. Pressure Monitor Port8. Input socket - Oxygen monitor

sensor

Data and Printer Ports9. Data Output10. Output to remote screen11. Ethernet12. USB13. VGA14. Printer port15. RS232

NOTEUSB port is for access only by engineerstrained by the manufacturer.All other data ports are read only.For further information, please contactKeomed PLN.

Gas Connections1. Ventilator drive gas inlet

- connect to anaesthetic machineauxiliary gas outlet

2. Bellows Drive Gas Output- connect to bellows

( on Prima SP2 with A200SP absorber,connect to absorber - see section 5.1.5)

3. Outlet - Exhaust Valve

Electrical Connection4. Electrical mains input and fuse unit

5.1.5 Bellows drive gas hose1. Prima SP2 with A200SP absorber: Connect

a 16 mm diameter corrugated hose betweenthe ventilator control unit drive gas outlet(labelled: DRIVE GAS) and the outlet (1) atthe rear of the A200SP absorber.

2. All other AV-S configurations:Connect a 16 mm diameter corrugated hosebetween the control unit drive gas outlet(labelled: DRIVE GAS) and the bellows baseDRIVE GAS inlet port.

5.1.6 Anaesthetic Gas ScavengingSystem

1. Connect the EXHAUST valve port on thecontrol unit to a properly functioningscavenging systemUse a 19 mm hose.

2. Fit a 10 cmH2O pressure relief valvebetween the exhaust valve port and the inletport of the AGSS receiver.Note that the diaphragm valve under thebellows is connected internally to theEXHAUST port to facilitate the discharge ofexcess breathing gas at the end theexpiratory phase.

WARNINGDo not use a scavenging system that restrictsdrive gas flow when negative pressure is exertedon it.Applying negative or positive pressure to thebellows exhaust port results in positive pressure inthe patient breathing system.Therefore, the scavenging system must notgenerate more than 0.5 cmH2O positive or negativepressure when connected to the ventilator.Any problem arising from an improperlyfunctioning scavenging system is solely the user`sresponsibility.

5.1.7 Remote ScreenAttach the DVI cable supplied with the screenbetween the interface connectors (1) on the rearof the control unit and screen.WARNINGCheck that the cable between the control unit andremote display screen unit is securely connectedbefore use.Always use a cable type recommended by themanufacturer.

5.1.8 PrinterAttach a printer to the printer port (2) if aprinted output of the ventilator function isrequired.

PRE-OPERATION PROCEDURES

43

1

1

2

AB

5.1.9 Breathing System 1. Connect the ventilator bellows base

BREATHING SYSTEM port to the breathingsystem.

2. a) Use a breathing system bacterial filter in theexpiratory limb of the breathing circuit toprotect the oxygen sensor.b) Use a heat and moisture exchanger(HME) at the patient Y piece. CAUTIONReplacement/Disposal - always follow theinstructions supplied with the filter or HME.Fit new components at the recommended interval.

3. Connect a 2-litre breathing bag to the patientconnection as a test lung.

4. Close the anaesthetic machine APL valve.

5.1.10 Spirometer 5.1.10.1 Flow sensors fitted to an A200SP

Absorber mounted on a PrimaSP2

1. Use a breathing system bacterial filter - seesection 5.1.8, operation 2.CAUTIONReplacement/Disposal - always follow theinstructions supplied with the filter.Always renew components at the recommendedinterval.

2. The two spirometry flow sensors aremounted within the A200SP Absorber in theinspiratory and expiratory airways.

3. Connect the cable assembly between theconnector at the rear of the A200SPAbsorber (A) and the the socket (B) at therear of the Ventilator control unit.

4. Check that the cable connections aresecure.

NOTEA) If the connections are incorrectly made, the

ventilator will alarm LOW TIDAL VOLUME or HIGHTIDAL VOLUME.

B) To allow the ventilator to be used in the event ofdamage, or non-functioning of the spirometerheads, turn off the spirometry function - see MENUfunction, section 3.5.

If the spirometer is switched OFF: a) Fresh gas compensation is disabledb) Fresh gas mixture compensation is disabled.c) Patient support function is disabled.

44

PRE-OPERATION PROCEDURES

PRE-OPERATION PROCEDURES

45

5.1.10.2 Spirometer CalibrationFlow sensors fitted to an A200SPAbsorber mounted on a Prima SP

The Spirometry heads must be calibrated with zeroflow going through them.

1. Turn the anaesthetic machine gas flow off atthe Gas Delivery on/off switch. This will stopall gas flows (including the AHD basal flow).This will also turn the AV-S off.

2. Turn the AV-S on at the ventilator (Do not usethe Prima SP Gas Delivery switch).or,Disconnect the fresh gas hose from the CGOblock on the anaesthetic machine.

3. Remove the breathing circuit hoses from theinspiratory and expiratory connectors (1) onthe absorber.

4. Disconnect the hose that connects the APLvalve outlet (2) at the rear of the manifoldblock to the AGSS receiver (or disconnect atreceiver).

5. a) Remove the bag, and set the Bag/Ventcontrol (3) to Bag position.or,b) Ensure that the ventilator bellows isempty,

6. Calibrate the spirometer via the ventilatormenu procedure.

7. Press the menu switch on the front panel.

8. Scroll down the main menu and select O2MONITOR & SPIROMETRY.

9. Select SPIRO CALIBRATION.

10. Press the wheel to initiate calibration.

11. Calibration is completed.

12. Scroll to ESCAPE FROM MENUS.

13. Press the wheel to confirm.

1

On/Off Switch

Alarm Mute

Menu Switch

NavigatorWheel andPress Button

3

2

O2 Monitor & Spiro

ESCAPE FROM MENUO2 MONITOR: onCALIBRATION: 100%HIGH ALARM SET: 105LOW ALARM SET: 18SPIROMETER: on

> SPIRO CALIBRATION: 0 L/min

..IOoo

PRE-OPERATION PROCEDURES

46

B

X

C

5.1.11 Pressure Monitor Connections

WARNINGThe High and Low Airway Pressure Alarms areimportant for patient care.The connection point must be properlylocated in the expiratory limb of the breathingsystem.

1. PATIENT PRESSURE port (A) on therear panel of the control unit:Use the tubing assembly supplied bythe manufacturer to connect to theexpiratory limb of the breathing system,close to the circle system expiratoryvalve.

2. Push-fit, self sealing connectors (B)Push in the tube as far as possibleDo not use excessive force.

The connector end piece X will alsomove inwards.

Pull the tube carefully outwards.The end piece X will be pulledoutwards to the locked position.

3. Connect the tubing (with adaptor, PartNo 053049) to the push-fit, self-sealingconnector (C) at the rear of theA200SP Absorber.

A

PRE-OPERATION PROCEDURES

5.1.12 Bellows Assemblies

Note that the bellows assembly is built intothe A200SP Absorber. For additionalinformation, please refer to the user manualfor that product.

CAUTIONAlways ensure correct fitment of bellows (seeillustration above), and carry out a full functiontest before clinical use, if a bellows is removedand refitted.

1. Remove the bellows housing (1).Twist carefully counterclockwise untilthe bayonet tabs become free, then liftup from the base (2).

2. Remove the bellows (3).3. Refit the bellows and check for

correct assembly, as illustrated (4). 4. Fit the bellows housing by pushing

down, then twisting clockwise until thebayonet tabs completely engage.

5. Function test the ventilator - section5.3.1.

NOTEIf there is any malfunction, the ventilator mustNOT be used.If the problem cannot be rectified, the ventilatormust be checked by an engineer trained by themanufacturer.

47

1

2

4

5

7

6

3

Paediatric Bellows Assembly

1. Remove the adult bellows housing(1) - twist carefully counterclockwiseuntil the bayonet tabs become free,then lift up from the base (2).Remove the bellows (3).

2. Fit the paediatric adaptor (5) - pressthe adaptor into the ventilator bellowsassembly base (2).

3. Fit the paediatric bellows (6) to theadaptor.Check for correct assembly, asillustrated (4).

4. Fit the paediatric bellows housing (7)to the base by pushing down, thentwisting clockwise until the bayonettabs completely engage.

5. Function test the ventilator - section5.3.1.

5.2 Pre-use Checklist

5.2.1 Daily Checklist

The following tests must be carried out at thebeginning of every working day:

Alarm SystemWARNINGThe operation of each alarm function should be verifieddaily. If the audible alarm or the visual display for any alarmfunction fails to activate during any alarm condition orfails to reset after the alarm has been cleared, refer theunit to an authorised service technician.

Back-up BatteryWARNINGIf the internal battery is fully discharged, the ventilatorwill not function.

Recharge the battery before the ventilator is usedclinically. Charging the battery for 14 hours from a dischargedstate will allow a minimum of 30 minutes ofcontinuous operation. Connect the ventilator to a mains power supply. Themains power indicator will illuminate to show that thebattery is being charged (it is not necessary to turn onthe ventilator).

Ventilator internal testPress the ON/OFF switch (1). A three-second internal test is initiated:1. The power -up screen is displayed.2. The audible alarm sounds.3. The ventilator reverts to STANDBY mode if no

selection is made.

NOTE special operating system on ventilators interfacedwith Prima SP2 (see section 3.5.2).a) Turn the anaesthetic machine Gas Delivery Switch to

ON - the ventilator will power-up.b) While machine power is ON, the Ventilator can be

turned OFF and ON, using the ventilator On/Off switch.c) Turn the machine Gas Delivery Switch to OFF. The

ventilator will power-down.

Calibrate the Spirometer - 5.1.10.2

Calibrate the O2 Monitor - 5.3.2

48

PRE-OPERATION PROCEDURES

1..IOoo

Function Test

1. Set the AIRWAY PRESSURE LIMITto 50 cmH2O.

2. PRESSURE TRANSDUCERconnectionCheck that the port on the rear of thecontrol unit is correctly connected tothe port on the rear of the absorberassembly (see section 5.1.10).

3.