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ventiPAC 200D Ventilator USER`S MANUAL

1. 04734 Pneupac Ltd 2002 PN 504 1117A Issue 6 11 2002 504 1117A Pneupac ventiPAC 200D Ventilator USER S MANUAL Pneupac Ltd Bramingham Business Park Enterprise Way Bedfordshire England LU3 4BU Tel 44 0 1582 430000 Fax 44 0 1582 430001 smiths 1 Smiths Medical a part of Smiths Group ple Page Intentionally Blank 504 1117A 2 ventiPAC 200D Ventilator User s Manual including Model Option EP TABLE OF CONTENTS Page SECTION 1 SUMMARY STATEMEN Fo vsssccssssccsssvssescsensscssticsoovessevecdsacassecdsescotessevsevesontseueboesees 5 a WARNINGS Warnings and Precautions c cccccccceeesesesnneeeeeeeeeeeeeenneeeeeeeeeeeeeennnaeeeeeeees 6 SECTION 2 GENERAL INFORMATION ccccccscsscoscsccoscsccoscsccesccccssccscssccsscscsssoscsscosesecs 11 a intended Use oa ooo 11 b General Descriptions sicions cafe eda as ie Oe etki A a R aaa dg Sea 11 6 CORTA IC AIA OTS A RIA ede als AED AAA ee AE EAT A ase ahaa 13 d Controls and Features Figures La and Dic iaa 13 e Options Covered by this Manual oooooooocccnnnccccnonononanccnnoconnnnnonannnnnnncnnononnnnnnononnnccnnnnnnnnnnnnnnos 20 EY SACCESSONIES E E AEA 22 SECTION 3 SET UP AND FUNCTIONAL CHECK ccccccccoscssccsssscssssscssscscccoscccsoscccsosccose 25 a A aE a T tabi cecaiue hocedatancebhs gadgeadebanceces R ana a e Anoia Sa 25 b Eunctional Check E a aa dene ieee 27 SECTION FOPERATION esa 31 a
2. 504 1117A 49 Low Battery Indicator This yellow light indicates that battery voltage is low Initially it flashes every 10 seconds This indicates that the battery is low although monitoring will continue The flashing rate increases to twice every second accompanied by a medium priority alarm for the final few minutes at the end of the battery life High Inflation Pressure Visual Alarm This red light flashes at 2 times per second after the high pressure relief valve has operated and whenever it is venting inflation gas to the atmosphere It is accompanied by a pneumatically generated audible alarm If the relief valve has operated for 3 successive cycles or for at least one second then the high priority audible alarm sounds and the visual alarm flashes continuously Both persist until 10 seconds after the condition is last detected They then automatically reset The same alarm signals are given if a continuous positive pressure greater than 10 x100Pa is detected for 10 seconds or more Cycle Indicator This green light flashes once for 1 10 second every time the patient inflation pressure rises through the pre set threshold pressure of 10 x100Pa 10cmH20 This indicates normal operation at Low Pressure Disconnect Visual Alarm This yellow light flashes 30 times per minu e if cycle etec or breathing etect has not been activated for 10 seconds It is accompanied by a medium priority alar
3. 3 PRECAUTION General Precautions Relating to Battery Safety Transportation and Disposal See Appendix A 504 1117A 10 SECTION 2 GENERAL INFORMATION a Intended Use The ventiPAC 200D is a portable ventilator designed for the ventilation of adults children and infants in and outside hospitals by personnel with medical training It is particularly suitable for ventilation during transportation and for providing rescue breathing and emergency resuscitation by well trained operators The 200D model is especially suitable for the treatment of victims in rescues from toxic or non respirable atmospheres as it offers the choice of 100 oxygen upon demand or ventilatory back up to the patient whilst normal breathing is being restored This CMV Demand feature may also be used for weaning patients back to normal breathing from controlled ventilation These ventilators are designed to be extremely economical in their use of driving gas and the Air Mix mode makes them particularly suitable for the long distance transport of patients using bottled oxygen or air see Section 8 b The ventiPAC ventilators and associated equipment described in this manual conform to European Standard EN794 3 Particular Requirements for Emergency and Transport Ventilators and comply with the requirements of the European Directive for Medical Devices 93 42 EEC WARNING To avoid the risk of explosion or interference where used on aircraft the use of this equ
4. During the expiratory phase the patient circuit is vented to atmosphere at 20 by means of the normally open valve 18 In the event of supply gas failure this allows the patient to breathe from the atmosphere without undue restriction It also vents the patient circuit to avoid patient valve lock up due to trapped pressure 504 1117A 43 Supply to the demand valve is taken directly from the inlet connection and its output is connected to the output connection via non return valve 9 The demand detector is connected to the demand valve and automatically senses the demand flow being taken by the patient whilst breathing spontaneously It operates in conjunction with the oscillator to integrate this signal and to extend the expiratory phase as a function of the spontaneous tidal volume up to a maximum time dictated by the frequency setting of the ventilator Thus if the patient demands a high flow for a short duration or a low flow for a longer duration for a similar level of tidal volumes an equal expiratory time will be allowed before the next ventilatory breath The cumulative effect of successive spontaneous breaths by the patient is that the ventilator appears to become inhibited although in fact this is only on a breath by breath basis In order to avoid inhibition by weak breathing or panting very low flows are ignored and no action is taken in response to very short breaths Inhibition starts at 150 ml and increases to a full inhibition
5. Expiratory Phase Interval from the start of expiratory flow to the start of inspiratory flow Expiratory Time Tg Duration of the expiratory phase FIO The oxygen content of the gases inspired by the patient expressed as a fraction Frequency f The number of ventilation cycles per minute breaths min Inspiratory Flow The flow delivered to the patient by the ventilator during the inspiratory phase Also see Minute Volume below Inspiratory Phase Interval from the start of inspiratory flow to the start of expiratory flow Inspiratory Time Tj Duration of the inspiratory phase VE Ratio The ratio of the Inspiratory Time to the Expiratory Time JAMA See CPR Lung Compliance Volume added per unit pressure increase when is added to a human or artificial lung Maximum Patient Inflation Pressure The maximum pressure that can be delivered by the ventilator to the patient Minute Volume Voe Delivered Total Ventilation or the volume per minute of gas delivered through the patient connection port during the inspiratory phases MRI Magnetic Resonance Imaging Mouth Pressure The patient inflation pressure as measured at the patient s mouth Patient Valve Valve that directs gas into the lungs during the inspiratory phase and allows expiration to atmosphere during the expiratory phase PEEP Valve A valve which is attached to the exhalation port of the pa
6. The gas supply pressure detector is built into the pneumatically operated visual indicator and is used to operate a medium priority audible alarm if the supply pressure drops to a level where the indicator shows red The inflation pressure detector is a pressure switch which senses the pressure at the outlet connector of the ventilator An output signal is given to the alarm control unit whenever the inflation pressure is greater that 10 x100Pa 10cmH20 The signal is used to determine if the pressure has passed through this threshold at least once in any 10 second period If not an alarm is provided in order to warn either of inadequate inflation pressure due to a leakage or failure to cycle or that the pressure is constantly above the threshold The relief valve detector is used to sense if gas is being vented from the patient circuit by the variable relief valve at the pressure set by the relief pressure control 504 1117A 44 The demand breathing detector is used to sense whenever the demand detector unit gives a signal to the ventilator control unit causing it to interact with the patient s breathing The signal is used to suppress the alarm in the same manner as the cycle detect signal The breathing detect visual indicator is operated to alert the operator that a spontaneous breath has occurred and that the low pressure alarm has therefore been temporarily inhibited The alarm unit is designed to operate from 3 volts and theref
7. Because the detector mechanism is preset small adults and children will not normally breathe adequately to fully inhibit the ventilator However even if full inhibition is not achieved the mechanism will normally cause the ventilator to synchronise with the patient s breathing to provide increased comfort for the weakly breathing patient WARNING Actuation of the breathing detect indicator only indicates that spontaneous breathing has been detected and that the low pressure alarm has been reset as a consequence The operator must still ensure that patient ventilation is adequate e Ventilating Intubated Patients When the patient is intubated the operator must be concerned with the implications of by passing the patients upper airway In particular the use of the Air Mix in a dust filled environment could introduce contamination into the patient s lungs and the drying effects of medical gas must also be considered Both of these potential problems can be effectively overcome by the use of bacterial filters which also acts as heat and moisture exchangers HMEs Pneupac would therefore strongly recommend the use of such devices when ventilating intubated patients at least for longer term ventilation Only HMEs conforming to EN ISO 9360 are recommended f Positive End Expiration Pressure PEEP PEEP can be applied to the patient circuit by the means shown in Figure 3 The exhaust collector adaptor shown allows a pop off type
8. The tidal volume required to completely inhibit the ventilator is fixed at approximately 450ml but the frequency is determined by the frequency setting on the ventilator If the patient is obviously breathing spontaneously and the ventilator is to be used solely to give 100 oxygen therapy or for rescue from a contaminated atmosphere then the Demand mode should be selected In this mode the patient will receive 100 supply gas upon demand and the ventilator will not operate If the patient is not breathing or if it cannot be established whether the breathing is adequate then the ventilator should be set up and applied in the normal way as already described If the patient makes a recovery and starts breathing it will be observed that breaths are occurring when the pressure monitor indicates in the negative sector and the green breathing detect indicator flashes see Sections 2 c 13 and 8 a If no positive pressure ventilations occur the patient is breathing adequately and the operator should switch either to Demand or remove the ventilator depending on the clinical indications If both negative and positive pressure ventilations are occuring slightly increase the expiratory time setting on the ventilator and note if the patient becomes more or less comfortable 504 1117A 33 With CMV Demand selected the Air Mix facility only operates with controlled ventilation Any demand breaths are always supplied as 100 supply gas
9. Users al cora o a a a doe duane a n 31 5 Setting of Ventilat r tada a a a a a Cont aa i Eaa Eas 31 Usok A MIX oirrne i e a E E E a E a eate 32 d se ONC MY Meme AA aA A aS aa a An aAA A ATSA AAE aaar 33 e Ventilating Intubated Patients cuatri id idas 34 Positive End Expiration Pressure PEEP cc cicic ccssacsddcsieissdesgaasdvesdedscdesdnasduesdacaeveadeasauesinsees 34 g Use in Contaminated AMOS PORTES 2 AA AA IA a RR 34 b MR Compatible ventilator and accessories oooooocccnnonoconcnnnonannnnnannnnnnnnnonnnnnnnnonnnnnnnnannnnnnnnnnnos 35 G User Information Label Table aiii disc oasis ali 36 SECTION 5 CARE CLEANING DISINFECTION STERILISATION oooccccccccocsicccccssonncos 37 OO 37 b Clean rennad nnan dunian adn dad ts lada pd 37 E DIST CO taa aia 38 d St rilisation ensenen enson n E E a a E E EA 38 e Reassembly and Function Testi A A A A a das 38 SECTION 6 MAINTENANACE 24 ccecccoccdesseauscssscssecetietvadesdoassdesseasscsetesseassbesuscessesssteesesvoussseedeats 39 a General era ira coin 39 b Performance CHECKING trotar Aniceto a Aeris 39 e Changing of battery sciis colada da ave 39 OS A o care 40 504 1117A 3 SECTION 7 ACCESSORIES and SPARE PARTS sscssssssssssssscsssscsssssssesssscssssscsssssssoees 41 SECTION 8 TECHNICAL INFORMATION sccssscssssssscsssscssscsssccsssscsssssssssssscsssssssssssssoees 43 a Prineiples f pera estat rola 43 0 ANC
10. system by temporary circuit disconnection and occlusion of the ventilator outlet connector both whenever the system is taken into a MRI environment and every time the patient is positioned within the magnetic field WARNING Training Requirements section 4 i ii All operators who are not medically qualified should receive full and proper instruction from a qualified person both on resuscitation and on detailed use of the equipment in the particular situations in which it might be employed see Section 1 a WARNING Use in Extreme Environments Section 4 and Appendix B Extreme environments may impair ventilator performance see Appendix B operator vigilance is required to monitor the patient WARNING Lithium batteries are of the primary type and are NOT designed to be recharged Attempts to recharge these batteries can lead to leakage and possibly an explosion Appendix A WARNING Do not use this ventilator in very confined spaces as oxygen concentration will be affected due to expired gas from the expiration valve entering the fresh gas intake port Where fitting in a confined space is necessary consult Pneupac for installation advice Section 2 e ii CAUTIONS Cautions warn of dangerous conditions that can occur and cause damage to the ventilator or its accessories if you do not obey all of the instructions given in this manual 1 CAUTION When storing for long periods to avoid the risk of possible corrosion
11. Clamp for Pole 12 26mm A4844 ICE Oxygen Therapy Unit with BS5682 Probe 6 L min A253 6 CE Regulator O Pin Index Cylinder Outlet for BS5682 Probe A162 CE connection with Outlet for BS5682 Probe variflow A162 Z43 CE selector Regulator with Outlet for BS5682 DIN 02 A166 CE O Probe and cylinder connection Bullnose A166 Z31 CE Sensing Line EP option W6832 1 6 CE Sling Carrying W7140 CE User s Manual 504 1117A Valve Patient for ventiPAC 200D V200D A4563 CE Valve PEEP 0 20 x100Pa 0 20cmH20 W7139 CE Wheel Valve Cylinder A171 CE Washer Pin Index Yoke pack of 3 276 3 CE Parts marked are available as MRI compatible variants Add suffix MRI to standard order code Parts marked are completely non magnetic as standard 504 1117A 42 SECTION 8 TECHNICAL INFORMATION a Principles of Operation The principles of operation of the ventilator are illustrated by the block diagram in figure 5 Compressed gas enters the ventilator from the input hose at the inlet connection 1 and this is fed to the main pneumatic switch 3 3 oe N pneumatic switch 6 12 CMV Demand Frequency Inflation Demand Switch Controls Pressure 4 ts Tns Monitor 1 fae To ie wy ali Valve 2 Ds 11 Variable Relief Valve 16 Air mix Switch Figure 5 Principle of operation of the demand version of the ventiPAC ventilator When t
12. Lithium batteries are not subject to EC requirements on the classification packaging and labelling of dangerous substances or preparations directives 67 548 EEC and 88 379 EEC as amended TRANSPORTATION AIR TRANSPORTATION Lithium batteries are exempt from IATA ICAO transport regulations under special provision A45 provided that they meet criteria given below ROAD TRANSPORTATION Lithium batteries are exempt from the ADR regulations under Marginal 2901a provided that they meet the criteria given below RAIL TRANSPORTATION There are no special requirements for the transportation of lithium batteries under the RID regulations SEA TRANSPORTATION Lithium batteries are exempt from the IMDG code under the special provisions of Page 9033 provided that they meet the criteria given below CRITERIA FOR EXEMPTION OF LITHIUM BATTERIES FROM TRANSPORTATION REGULATIONS l Each cell contains not more than 1 gram of lithium or lithium alloy Ze Each battery contains not more than an aggregate quantity of 2 grams of lithium or lithium alloy 3 Cells are separated so as to prevent short circuit 4 Batteries are separated so as to prevent short circuit and are packed in strong packaging except when installed in electronic devices 5 If a battery contains more than 1 gram of lithium or lithium alloy it does not contain a liquid gas that is considered dangerous unless the liquid or gas if free would be completely ab
13. adverse ventilation conditions can be detected and corrected before the patient is put at risk When ventilating with a mask the peak inflation pressure should ideally be kept below 20 x100Pa 20cmH2O to minimise the risk of inflation of the stomach If the pressure jumps excessively at the commencement of inspiration an airway obstruction is indicated and this must be rectified If the airway is clear the inspiratory flow may be too high and this should be reduced Excessive pressure at the end of inspiration may indicate low lung compliance or may indicate a high tidal volume This may be reduced by either reducing the flow or the inspiratory time Tp but ensure that adequate chest movement is maintained When ventilating with an ET tube a higher pressure will normally be observed but if abnormally high either kinking of the tube or excessive ventilation should be suspected If the inflation pressure is too low particularly if the low pressure alarm operates firstly check for leaks secondly check the ventilation parameters thirdly check the patient valve for proper functioning WARNING To ensure that ventilation can be maintained without interruption keep a constant check on the adequacy of gas supply by observing the gas cylinder contents indicator and the gas failure visual alarm c Use of Air Mix The air mix switch allows for the selection of ventilation of the patient with 100 supply gas or with the supply gas diluted by
14. of 450 ml The level of spontaneous breathing required to fully inhibit the oscillator is fixed at that of a typical adult This is taken as a tidal volume of about 450 ml at 12 to 16 b min Higher spontaneous ventilation rates can readily be taken and will result in complete inhibition of the ventilator Lower ventilation rates as may be taken by a small adult or a child will only give partial inhibition but providing the demand flow is above 15 l min the ventilator will still interact with the patient and synchronise its ventilation pattern with the spontaneous breathing When the main pneumatic switch is turned off the demand valve remains active whilst the ventilator is connected to a gas supply In this mode therefore the patient can be given 100 oxygen with the economy of use offered by a demand valve or the spontaneously breathing patient can be largely protected from the effects of a non respirable or toxic atmosphere The multifunction alarm built into the ventiPAC 200D ventilator is electrically powered by a replaceable single cell lithium battery but the ventilatory functions of the ventiPAC ventilators are completely independent of the alarm functions and its power source The alarm unit is microprocessor controlled and has four preset pressure level detectors which monitor respectively the gas supply pressure the inflation pressure operation of the pneumatic pressure relief valve and operation of the demand breathing detector
15. operation or testing or if its performance is measured to be outside the tolerance stated in the specification see Section 8 b amp c during its performance checking then the unit must be withdrawn from operation and an appropriate service must be carried out Servicing or adjustment of the ventiPAC ventilator should only be carried out by competent personnel who have been trained by the manufacturer for such work WARNING Failure to use approved circuits and accessories may lead to unsatisfactory ventilator performance WARNING The ventiPAC ventilator is manufactured and CE marked to the requirements of 93 42 EEC To ensure that this equipment functions as intended use only the manufacturer s authorised spares 504 1117A 40 SECTION 7 ACCESSORIES and SPARE PARTS WARNING The ventiPAC ventilator is manufactured and CE marked to the requirements of 93 42 EEC To ensure that this equipment functions as intended use only the manufacturer s authorised spares Description Order Code Airway Guedel Disposable Size 00 Paediatric W6873 CE Size O Paediatric W6874 CE Size 1 Child W6875 CE Size 2 Adult W6876 CE Size 3 Adult W6877 CE Battery General Purpose not for MRI use Type 123A 3V Lithium widely available camera battery MRI and General Purpose Use W269 023 Battery Retaining Cap 510 A1845 Case c
16. or drain of the battery ensure that the ventilator is left in the off position and the battery removed Section 2 d 15 CAUTION To ensure that the cylinder contents are not lost during storage due to small leakages it is recommended that the valve on the gas cylinder is turned off after use Section 2 b 13 General Precautions Relating to Battery Safety Transportation and Disposal See Appendix A CAUTION To avoid damge to the EP circuit detach all EP Circuit parts from the Patient Hose prior to autoclaving DO NOT autoclave EP Accessories 504 1117A 9 PRECAUTIONS Precautions warn of actions required to avoid dangerous or undesirable conditions that can occur and cause damage to the ventilator or its accessories if you do not obey all the instructions given in this manual l PRECAUTION Protection of Battery and Ventilator During Periods Without Use Section 2 d 15 To avoid any drain on the battery if the ventilator is unlikely to be used for a long time or is placed in storage ensure that the main pneumatic switch is left in the Demand ventilator off position It is also recommended that the battery is removed from its holder to avoid possible corrosion due to leakage of its contents De PRECAUTION Prevention of Gas Loss Section 3 b 13 It is recommended that the valve on the gas cylinder is turned off after use to ensure that the cylinder contents are not lost during storage due to small leakages
17. this manual At the second level the performance of the ventilator should be checked as specified in Section 6 b b Performance Checking Performance checking of the ventiPAC ventilator must be carried out with equipment calibrated to ensure accuracy under the flow patterns generated by the machine It should be carried out by suitably trained personnel If suitable personnel or equipment are not available it should be checked by the Pneupac as part of a service contract or its authorised representative Recommended performance checking procedures and suitable equipment are detailed in the product maintenance manual which is available to suitably trained personnel The frequency of performance checking should be determined by the user depending upon the intensity of use Normally this would be not more often than once every 6 months but at least once every 2 years c Changing of battery The specified batteries will give several years of service under normal use conditions but to avoid the need to locate a spare battery whilst the ventilator is in field service it is recommended that the battery is replaced as a matter of routine at the same time as the performance checking as specified in Section 6 b above If the equipment is checked every 6 months and the date of the battery changing is recorded replacement is only necessary every second check i e annually The procedure for changing the battery is as follows see section2 c 15
18. ventilation to the calibration using the No Air Mix setting If the peak inflation pressure is noted the flow control can be adjusted to achieve the same inflation pressure after selecting Air Mix The calibrated flow will now be delivered At low flow settings with Air Mix selected and oxygen as the supply gas the delivered oxygen concentration will be higher than 45 The exact rise will be dependent upon the flow setting and the patient compliance and resistance see Appendix B but if the concentration requirement is critical oxygen monitoring equipment should be used d Use of CMV Demand WARNING Failure to constantly monitor the patient whilst using this equipment may lead to death or serious injury WARNING Because this function has characteristics specific to this range of ventilators it is important that the sections of the operating instructions describing this facility Sections 2 b and 4 d are read before this version of the ventiPAC ventilator is used so that the operator understands how the ventilator interacts with the patient during spontaneous breathing The Model 200D ventilator incorporates a facility to detect spontaneous breathing by an adult patient and to inhibit the ventilator appropriately to the level of the breathing If breathing is adequate for an adult the ventilator is entirely inhibited If it is not entirely adequate the ventilator will interpose ventilations synchronised with the patient s efforts
19. which is achieved in the Air Mix mode 6 Inflation Pressure Monitor This pressure manometer displays the patient inflation pressure as measured at the ventilator outlet It will give an accurate indication of the actual patient proximal inflation pressure under all normal settings of the ventilator It will not display exhalation pressure although this will only be relevant if attachments such as a PEEP valve are added to the patient valve See Terms and Definitions Section 8 d 504 1117A 14 This arrangement is to be preferred for emergency use because it requires the simplest patient circuit and there is less probability of disconnection occurring as a result of snagging of the circuit The EP model option provides external pressure sensing connectors and an external sensing line so that the inflation pressure can be measured at the patient connection point This may be considered an advantage if the ventilator is to be used mainly for patient transport and PEEP is frequently used See Section 2 d 1 PEEP value will also be shown if the circuit is connected properly WARNING Direct Patient Inflation Pressure Sensing EP Option 1 Although there is no net flow in the sensing line it is recommended that a microbial filter is always inserted in the sensing line to ensure that no patient contamination can enter the manometer circuit within the control module WARNING Direct Patient Inflation Pressure Sensing EP Option 2 V
20. 100 46 100 46 100 46 100 46 100 yas i MAX 0 100 0 1 100 0 2 100 0 3 100 0 4 100 0 5 100 0 5 100 1 100 Mis MIN o 100 1 100 1 5 100 2 100 25 100 3 100 3 5 100 7 100 selected 504 1117A 62 ventiPAC APPENDIX C Cleaning and inspection record log check 504 1117A 63 Page Intentionally Blank 504 1117A 64 APPENDIX C CLEANING AND INSPECTION RECORD LOG CHECK Contents Cleanliness Functional Cylinder Date Signature Comments Complete Checked Performance contents Check section 3 b 504 1117A 65 Page Intentionally Blank 504 1117A 66
21. 75 60 2 30 breaths per minute The ratio of Inspiratory Time to Expiratory Time I E ratio can be set as required Typically this will be set at 1 2 or within the range 1 1 to 1 3 Frequency Flow Control This rotary control knob gives continuous adjustment of delivered ventilatory flow over the range 0 1 to 1 0 litres per second Between 0 25 and 1 0L sec this flow is relatively unaffected by lung compliance and airway resistance or by switching between Air Mix and No Air Mix At lower flow settings with Air mix selected the delivered flow becomes increasingly dependent upon the inflation pressure being generated as explained in Section 4 c 504 1117A 13 The product of flow in L sec and inspiratory time in seconds gives the delivered tidal volume in litres e g if the flow is set to 0 5 L sec and the inspiratory time to 1 0 second the delivered tidal volume is 0 5 x 1 0 0 5 litre 500ml 3 Main Pneumatic Switch This knob operates a rotary switch to select Demand only or the CMV Demand facility which provides controlled mandatory ventilation to non breathing patients but which allows inhibition if an adult patient commences spontaneous breathing to an adequate level WARNING Because this function has characteristics specific to this range of ventilators it is important that the sections of the operating instructions describing this facility Sections 2 b and 4 d are read before this version of the ventiPAC ve
22. C ventilator is switched off Under general use conditions the specified batteries will give at least one year s service before requiring replacement CAUTION When storing for long periods to avoid the risk of possible corrosion or drain of the battery ensure that the ventilator is left in the off position and the battery removed WARNING BATTERY FOR MRI USE WARNING To avoid projectile risk in a MRI environment use only the approved MRI compatible battery Part No W269 023 Do not attempt to remove the battery from the ventilator or take a loose battery in a MRI environment WARNING To prevent possible risk of projectile injury within a MRI environment routinely check for magnetic attraction PRECAUTION To avoid any drain on the battery if the ventilator is unlikely to be used for a long time or is placed in storage ensure that the main pneumatic switch is left in the Demand ventilator off position It is also recommended that the battery is removed from its holder to avoid possible corrosion due to leakage of its contents 16 Basic Operating Instructions This panel on the ventilator gives basic operating instructions to assist the infrequent user of the ventiPAC ventilator It is not intended to replace in any way the more comprehensive instructions and information given in this handbook A chart on the label provides a useful look up table for easy determination of Tidal Volume and Frequency with reference to Inspira
23. E Ratio Infinitely adjustable Duration of Gas Supply 1 22 min L cylinder capacity 200 x100kPa 200 bar charging pressure when set to deliver 9 6 L Minute Volume at 12 breaths min delivering 100 O at an I E ratio of 1 1 6 This is equivalent to 52 minutes from a 2 7 L D size cylinder 2 60 mins L cylinder capacity 200 bar charging pressure when set to deliver 9 6 L Minute Volume at 12 breaths min at an I E ratio of 1 1 6 with Air Mix selected This is equivalent to 160 minutes from a 2 7 L D size cylinder Relief Pressure Range 20 80 x100Pa 20 to 80cmH 0 accompanied by audible alarm Maximum Limited Pressure 100 x100Pa 100cmH 0 Inflation Pressure Monitor Indicates from 10 to 100 x100Pa 10 to 100cmH 0 Sensing Line Filter 25mm dia in line hydrophobic filter flow resistance lt 50 x 100Pa at 4 EP option only L min particle retention rating gt 99 999 DOP aerosol 0 3 0 4 um with face velocity 10 L min Air Mix 0 or 70 air mix selectable providing 100 or 45 O when using oxygen as gas source 1 x100Pa 1 02 cmH 0 or 1 x100Pa 1 cmH20 2 504 1117A 46 Gas Consumption No Air Mix Y peL plus 20 ml cycle Air Mix 30 V peL plus 20 ml cycle Demand Parameters Demand Flow commences at 2 x100Pa 2cmH O 100 L min at 8 x100Pa 8cmH O maximum gt 120 L min These demand sensitivities are with 400 kPa supply
24. LAS aa lb loss 47 d Terms and DEIA o 48 e Explanation of Symbols and Alarm Condition Indicated ooonnnoncccnnnoooccnonnnonannnonaonnncnnnannnos 49 Indicated Priority of Audible Alarm SOUNAS oooonnnnncoccnononancnonanannnnonannnnnnnnnonnnnnn nano nnnnnnnnonos 50 2 MR Compatibility Testin misinis aiai aa lirio iglesia 51 G EQUIP A A Olin che gti eee 51 APPENDIX A PRODUCT SAFETY TRANSPORTATION AND DISPOSAL OF RECOMMENDED BATTERIES secs sicsisccuscsisdiecdesscoucsisseiieosdscsudsssccsscdsicedsacsstesdecsusesdessevcsvedsesesssass 55 APPENDIX B CALIBRATION ACCURACIES AND DEVIATIONS DUE TO CHANGE IN AMBIENT CONDITIONS o cii nisianaria iaa aii ti 61 APPENDIX C CLEANING AND INSPECTION RECORD LOG CHECK cccssoosees 65 List of FIGURES amp TABLES Page Figure la Front view of ventiPAC showing accessories features and the EP option eee 13 Figure 1b Rear and side view of ventiPAC sige sch as 17 Figure 1c Detachable part of ventilator breathing system for demand version esseeeeeeeeeee 19 Figure 2a and Figure 2b PLUS 2 CR cava eet A AA ESS 21 ti o O EE aE EK E E TE a E aS 21 Figure 3 Connection of the patient valve PEEP valve Exhaust collector accessories 22 Figure 4 Contents of Instant Action Set option and correct stowage eeessssessserersreererresrreresereees 26 Table 1 ventiPAC 200D User Information Label 0 ecccccceeecncceeesecnecteeseo
25. PEEP valve to be attached to the exhalation port of the patient valve As stated earlier the Inflation Pressure Monitor will not indicate exhalation pressure except when the EP option is deployed where the pressure can be observed so the setting of the PEEP control should be carefully observed The pressure monitor will show the sum of the PEEP and the airway pressure drop as a step change at the commencement of inspiration and the effect of PEEP changes can be observed in this way g Use in Contaminated Atmospheres WARNING The ventiPAC ventilator models are suitable for use in contaminated and toxic atmospheres subject to certain limitations as described below and these should be clearly understood by those likely to use the equipment in such environments so that it is only used where appropriate WARNING In any situations where the respirable qualities of the immediate environment are suspect ventilation should only be carried out in the No Air Mix mode This ensures that only a minimum of ambient gas can enter the breathing system If the victim is breathing weakly or intermittently the tidal volume should be adjusted to ensure that the ventilator controls the entire breathing pattern If the victim is breathing strongly the ventiPAC ventilator should be used with the Demand mode selected 504 1117A 34 In either of the above modes of operation some of the surrounding atmosphere will enter the breathing system during spont
26. Pneupac C uz Pneupac Ltd Luton LU3 4BU England Tel 44 0 1582 430000 MR Compatible with MRI Battery 504 1117A Testing has confirmed compatibility at 3 Testa and 430G cm with RF at 0 82Wikg and 125 5MHz but intended use is with this contro module away from magnet bore Table 1 ventiPAC 200D User Information Label 36 SECTION 5 CARE CLEANING DISINFECTION amp STERILISATION a Care The ventiPAC ventilator is designed to operate in the face of the tough treatment it may receive during its intended use but to prolong its life and retain its appearance basic care should be taken in its cleaning and stowage between uses In particular the following steps are recommended to be taken after every use i Carefully inspect the complete system and make note of what actions should be taken In particular check for damage to hoses or masks contamination of any component evidence of any part having been subjected to excessive force missing parts and gas cylinder contents 11 Clean or sterilise all parts as necessary iii Reassemble the system and carry out the functional check specified in Section 3b iv Stow the system in a clean area or in its carrying case away from heat and intense light b Cleaning i Control Module The control module may only be cleaned by means of a damp cloth For obstinate marks a mild soap or non abrasive cleaner may be used Wipe dry immediately with a soft clean cl
27. This ensures that nuisance alarms do not occur due to the absence of positive ventilation when the patient is breathing spontaneously See section 8 e amp f for explanation of symbols and description of alarm priorities 504 1117A 16 14 Low Battery Alarm A yellow visual indicator is used to indicate that the internal battery used to power the alarm unit is giving reduced voltage With the 123A battery it will flash once every 30 seconds for several hours of use as an early warning that the battery will need to be replaced With both of the recommended batteries the flashing rate will increase to twice every second accompanied by a medium priority audible alarm for the final few minutes of the battery life When operating at very low temperature the life of the battery will be reduced When the alarm is operating normally as indicated by flashing of either the silencing indicator or one of the two green indicators the absence of any signal from the low battery indicator confirms that the battery voltage is adequate to operate the alarm system correctly Refer to Section 6 c for recommendations concerning battery replacement 15 Figure 1b Rear and side view of ventiPAC Battery The electronic alarm unit is powered by means of a single cell lithium battery retained in a battery holder on the right hand side of the ventilator There are two alternative sized batteries which can be fitted For normal use the readily availa
28. al and basic operating instructions are provided on the label affixed to the control module WARNING To avoid harm to the patient this equipment should only be used by personnel trained in the use of automatic ventilation SECTION 1 a The equipment should only be used by medical personnel who have a full understanding of the techniques required for its use or paramedical personnel who have received full and proper initial and refresher instruction from a qualified person both on resuscitation and on detailed use of the equipment in the situations in which it is likely to be employed Information given in this manual beyond the basic operation of the ventilator is only intended as a guide to supplement proper medical training and to indicate the specific operational requirements of the ventiPAC ventilator WARNING Federal Law USA restricts the use or sale of this device by or on the order of a physician WARNING To avoid harm to the patient this equipment should only be used by personnel trained in the use of automatic ventilation WARNING Failure to constantly monitor the patient whilst using this equipment may lead to death or serious injury WARNING Blood gas levels must be monitored independently correct operation of the ventilator will not necessarily achieve the required blood gas levels The ventiPAC ventilator is intended only for use in transport and emergency situations where the patient is being constantly monitore
29. ambient air in the ratio 1 2 Where high oxygen concentrations are required such as during initial resuscitation use the No Air Mix setting and oxygen as the supply gas Where 45 oxygen concentration is required use an oxygen supply and select Air Mix In this setting a bottled gas supply will last three times as long and therefore this setting is preferred wherever possible once the patient is stabilised If air is used for the supply gas to conserve the supply the Air Mix setting should be used at all times except when in contaminated or toxic atmospheres For ventilation in contaminated atmosphere see appropriate section When the flow control is set to its lower settings with Air Mix selected the actual tidal volume and oxygen concentration delivered to the patient will become increasingly dependent upon the inflation pressure being generated The Table in Appendix B indicates the effects that can be expected 504 1117A 32 The ventilator is calibrated such that at normal inflation pressures the flow calibration accuracy is maintained At high or low inflation pressures the calibration accuracy should not be relied on when Air Mix is selected and low flows are being delivered However in most cases the operator will be using additional indicators to assess adequate ventilation eg inflation pressure and pulse oximetry If it is required to set the ventilation more accurately then this can be achieved by first setting the
30. an be closed up without distorting them unduly Stow Guedel airways 4 in the individual elastic loops provided Coil and stow shoulder strap in the end loop Stow accessories as provided the spare mask and Clausen harness in the loops the anti inhalation valve PEEP valve and any other items in the shallow side pocket Place Oxygen Therapy Set in the large side pocket The aspirator 5 is retained by loops in the end wall and the suction tube and probe are stowed in the adjacent pocket For details of accessories see Section 2 e Place this Manual 6 in the central pocket for use and reference WARNING To avoid harm to the patient pre use checks must be performed before each use Functional Check The following procedure should be followed when first setting up the ventilator to check that it has been assembled correctly and is operating safely It should be repeated periodically as specified under Maintenance Check the ventilator controls as follows Main Pneumatic Switch CMV Demand Inspiratory Time 1 5 Seconds Expiratory Time 3 0 Seconds Inspiratory Flow 0 5 L sec Air Mix Switch No Air Mix Relief Pressure 40 x100Pa 40cmH20 Connect the probe on the input hose to an appropriate gas outlet WARNING Avoid smoking or naked flame To avoid the risk of ignition do not use oil grease or combustible lubricants only those approved for oxygen use in contact with any part of the ventilator regulator or cyl
31. aneous breathing as a result of venting ports within the ventilator This dilution will be worst at low breathing levels particularly below the level at which inhibition occurs and therefore under these conditions the ventiPAC ventilator should be set to take control of the breathing Pneupac can supply special models with a much reduced dilution against specific requirements Ultimately however only the use of a pressurised breathing apparatus will provide full protection for a patient breathing spontaneously h MR Compatible ventilator and accessories Ventilators of the type covered by this manual have been tested and have been assessed to be MR Compatible when placed in a magnetic field of 3 Tesla and a field gradient of 430G cm Full details of the tests are given in Section 8 g Although as recommended by FDA guidelines the ventilator was tested at the most extreme field strengths and gradients both of which were within the bore of the magnet good ventilation practice would dictate that the ventilator control module is always placed outside of the bore so that the monitoring can be properly observed and the controls can be adjusted as necessary This is the intended position of use of the ventilator Recommended practice is to fix the ventilator to the end of the couch with eg Velcro strapping to prevent it falling off whilst the patient is being moved The patient circuit can be suitably extended by adding one or two additional le
32. arrying comprehensive A177 Z1 CE Control Module ventiPAC 200D 510A 1956 MRI compatible as standard Cylinder Lightweight Aluminium Comprehensive full W6837 CE empty W6838 CE Exhaust Collector 30mm Male W7131 CE EP Patient Circuit Assembly 510A2338 Filter Assembly EP sensing line 510A1768 CE Gauge Cylinder Contents W6829 CE Harness Clausen W687 1 CE Hook Ring W6872 CE Knapsack W8654 CE Hose input 1 5 metres long BS5682 Oxygen G 1 4 standard hose A498 1 ICE BS5682 Air G 1 4 standard air hose A4982 CE_ Open ended G 1 4 A4983 DISS DISS oxygen A4984 DISS DISS Air A4985 DIN DIN air oxygen A4986 CE Parts marked are available as MR Compatible variants Add suffix MRI to standard order code Parts marked are completely non magnetic as standard 504 1117A 41 Description Order Code Hose input 1 5 metres long Mini Schrader oxygen G 1 4 A4987 Mini Schrader air G 1 4 A4988 Hoses up to maximum 15 metres available Patient Hoses 1 2 metres long W7130 CE Heavy Duty 1 2 metres long W7486 CE Hoses Oxygen Therapy with BS5682 Probe 6 L min flow A254 6 CE Lightstick Pack of 10 W6858 10 CE Pack of 50 W6858 50 CE Masks Oxygen Therapy Disposable Pack of 5 A369 CE Adult Clear W6807 CE Child Small Adult Clear W6806 CE Paediatric Size 1 W6804 CE Paediatric Size 0 W6803 CE Mounting Clamp for Medical Rail 30 35mm A4843 ICE Mounting
33. be carried out during the periodic test and after reassembly of the patient valve every time it is dismantled Connect the ventilator to a gas source and set the inspiratory and expiratory times to give a frequency of about 30 b min set the Flow control to minimum and the air mix switch to Air Mix Attach a flexible reservoir bag preferably 1 2 litre to the patient connector of the patient valve and switch on the main pneumatic switch Roll up the end of the reservoir bag to decrease its effective volume until the end inspiration inflation pressure rises to about 10 x100Pa 10cmH20 Check that this pressure can be attained consistently every breath If it cannot dismantle the patient valve turn the yellow valve element about a quarter of a turn and reassemble and retest If after two or three adjustments consistent performance cannot be achieved the valve element must be replaced 504 1117A 28 13 Finally set the controls as specified in step 1 so that the ventilator is left set for emergency use WARNING Deviations noted at functional check should be reported immediately to Pneupac and the unit must be taken out of service to avoid the risk of death or serious injury WARNING Avoid smoking or naked flame To avoid the risk of ignition do not use oil grease or combustible lubricants only those approved for oxygen use in contact with any part of the ventilator regulator or cylinder WARNING To avoid ignition by adiabat
34. ble At least one mask should also be kept available for emergency use Ventilating Patient Connect supply hose probe to gas supply Slowly turn on gas supply 1es if relevant Check that the visual alarm for supply gas failure has changed from red to white Turn main pneumatic switch to CMV Demand Check that the alarm indicators flash in sequence to indicate correct function Set ventilation parameters to suit the patient refer to table 1 on page 35 SOMO Briefly occlude the patient connection port of the patient valve with the thumb Check that the peak inflation pressure reading on the manometer is appropriate for the patient and that the pneumatic audible alarm sounds and the high inflation pressure indicator shows red 8 Apply face mask to patient ensuring that the airway is free or connect patient valve to endotracheal tube ET tube 9 Check chest movement and Inflation Pressure Manometer to ensure correct ventilation 10 Check that the green cycle indicator light flashes during each inflation as the pressure rises 504 1117A 31 11 Make adjustments as necessary 12 Temporarily disconnect the ventilator circuit at the connection closest to the patient and verify that the green light fails to illuminate during an inspiratory phase Immediately reconnect circuit The patient s condition and chest movements as well as the Inflation Pressure Monitor should be kept under constant observation so that
35. ble size 123A 3V lithium battery as widely used in cameras can be fitted However in MR environments it is essential that the special low ferrous content battery supplied by Pneupac and marked For use in MR Compatible ventilators is used This battery is in a size AA packaging but provides 3 6V and has a non metallic casing It has been specially selected as having minimal ferrous content such that when installed in the ventilator it produces no noticeable effect Only this battery should be used when the ventiPAC 200D is used as an MR Compatible ventilator It must be noted that no battery of this type commercially available is completely free of ferrous content and so it must never be removed from the battery compartment of the ventilator in the presence of a magnetic field See section 8 f for explanation of description of alarm priorities 504 1117A 17 The battery is retained by means of a reversible retaining cap which is removed by a quarter turn anti clockwise twist using a coin in the slots provided During insertion of a new battery the cap should be orientated according to the battery type being used With the MRI battery inserted the cap should be fitted with the yellow MRI visible after assembly whereas with the standard size 123A battery the MRI with a red cross through it should be visible Lithium batteries have an expected shelf life of 10 years and there is no current drain on an installed battery when the babyPA
36. cants only those approved for oxygen use in contact with any part of the ventilator regulator or cylinder To avoid ignition by adiabatic compression connect the ventilator to the regulator before opening the cylinder valve slowly Similarly prior to changing cylinders turn off the cylinder valve switching on the ventilator When the ventilator stops it is safe to release the pin index yoke 7 WARNING Use in Aircraft Section 2 a To avoid the risk of explosion or interference where used on aircraft the use of this equipment must be authorised by the Aviation Authority and the Aircraft Operator 8 WARNING Use of CMV Demand Facility Section 2 d 2 Because this function has characteristics specific to this range of ventilators it is important that the sections of the operating instructions describing this facility Sections 2 b and 4 d are read before this version of the ventiPAC ventilator is used so that the operator understands how the ventilator interacts with the patient during spontaneous breathing 504 1117A 6 10 11 12 13 14 15 WARNING Direct Patient Inflation Pressure Sensing EP Option 1 Section 2 d i and 2 d 6 Although there is no net flow in the sensing line it is recommended that a microbial filter is always inserted in the sensing line to ensure that no patient contamination can enter the manometer circuit within the control module WARNING Direct Patient Inflation Pressu
37. carrying sling or mounting bracket has been supplied attach it to the module as shown in Figure 2 Insert the battery into the module battery holder as described in Section 6 c Because there is no battery fitted in the holder it will be necessary to tip up the module in order to remove the battery retaining cap Assemble the patient circuit and connect it to the control module as shown in Fig 1 a Note that the hose is attached to the fixed taper limb of the patient valve which is at an angle to the body The mask is attached to the swivel taper Connect the input hose to the inlet connector as shown in Figure 1 a and tighten the securing nut lightly using a spanner wrench The probe on the input hose is gas specific to the standard specified when ordering Any of the Pneupac hoses listed in the ventiPAC Accessories and Spare Parts List can be used with the ventilator provided the same inlet connection is specified 11 Instant Action Set Unpack the equipment and lay out the contents so that each component is identified Make reference to the illustration Fig 4 for the stowage of all items Lightweight aluminium Pin Index D size cylinders may be purchased from Pneupac WARNING Avoid smoking or naked flame To avoid the risk of ignition do not use oil grease or combustible lubricants only those approved for oxygen use in contact with any part of the ventilator regulator or cylinder Remove plastics wrapper from cylinder valve Mo
38. d by remote measurement Projectile Risk At no point along the axis of the magnetic field did the ventilator present a projectile risk but for a distance of about 15 cm around the point of maximum field gradient 430 G cm approx 40cm inside the bore of the scanner slight restraint was necessary to prevent gentle sliding if the ventilator was rested directly on the hard surface of the carriage Ventilator performance tests The ventilator was set to a nominal 1100 Vr and 20 bpm providing a peak inspiratory pressure of 41x 100Pa 4lcmH2O It was placed in turn at the extreme outer edge of the table at the mouth of the bore 168G cm at the point of maximum magnetic field gradient 430G cm approx 40cm in from the mouth of the bore and at the isocentre of the magnet 3 Tesla At no point could any change in the delivered ventilation be detected and the electronic monitoring operated consistently Trial circuit disconnections and airway obstructions were always indicated correctly A small reduction in the set level of the inflation pressure relief valve was observed the maximum change being about 12 in the 3 Tesla field but in normal use this valve will be set with sufficient margin for this change not to affect the ventilation Similarly the inflation manometer deviated by up to 3 x100Pa 3cmH2O at the position of maximum field gradient Neither of these deviations was evident at the intended position of use outside the bore o
39. d by the carer The integrated alarm unit is intended to alert the carer to changes in the patient s ventilation but it cannot ensure that the patient s blood gases are maintained at the required level Therefore patient monitoring devices e g a pulse oximeter and other recommended devices should additionally be used where appropriate 504 1117A 5 a WARNINGS Warnings and Precautions WARNINGS Warnings are given to make you aware of dangerous conditions that could lead to death or serious injury to the user or patient that can occur if you do not obey all of the instructions given in this manual 1 WARNING Failure to read this User s Manual before first use of this device may result in death or serious injury 2 WARNING Federal law USA restricts the use or sale of this device by or on the order of a physician 3 WARNING To avoid harm to the patient this equipment should only be used by personnel trained in the use of automatic ventilation SECTION 1 a 4 WARNING Failure to constantly monitor the patient whilst using this equipment may lead to death or serious injury SECTIONS 1 a 5 WARNING Blood gas levels must be monitored independently correct operation of the ventilator will not necessarily achieve the required blood gas levels SECTION 1 a 6 WARNING Use of Oxygen Section 3 a and 3 b 13 Avoid smoking or naked flame To avoid the risk of ignition do not use oil grease or combustible lubri
40. d fixing screws supplied with the bracket The rail bracket is of the universal type and attaches to 35 30 mm rails of either 6 5 or 10 mm thickness and of the form shown in Fig 2 d A quick release clamp with a screw back up is used The pole mounting bracket attaches to the module in the same way and accommodates vertical pole diameters of 1 2 1 12 26 mm A screw with a T handle is used for clamping Figure 2d Figure 2e WARNING Do not use this ventilator in very confined spaces as oxygen concentration will be affected due to expired gas from the expiration valve entering the fresh gas intake port Where fitting in a confined space is necessary consult Pneupac for installation advice 504 1117A 21 f Accessories WARNING Failure to use approved circuits and accessories may lead to unsatisfactory ventilator performance An Instant Action carrying case can be supplied which is specially designed to carry a ventiPAC ventilator a D sized gas cylinder and a wide range of accessories It enables a comprehensive set of pulmonary ventilation equipment to be carried for immediate action at Fig 3 shows the general arrangement of the set opened out ready for action and complete with the optional gas powered aspirator and an oxygen therapy set Velcro fasteners are used to ensure easy and reliable access even under the most extreme conditions Pockets and straps are available for accessories such as PEEP valves Guedel airways a
41. d may also be used with a nebuliser The Pneupac patient valve supplied with the ventiPAC ventilator can be fitted with a PEEP valve by means of an exhaust collector see Fig 3 This collector is a push fit onto the body of the patient valve and connects the exhalation ring to a 30 mm male taper connection port without interfering with the function of the valve Pneupac can supply a compact PEEP valve to fit onto this port with an adjustment range of 0 20 x100Pa 0 20cmH20 PEEP setting is Before using PEEP with the ventiPAC ventilator refer to Section 4 f of this Manual vi PEEP Valves by means of a calibrated adjustment knob vit Clausen Harness and Hook Ring A Clausen harness and Hook ring can be supplied to strap the face mask to the victim s face for rescue from difficult situations e g in tunnel rescue or when hoisting WARNING Because the operator is no longer supporting the head and chin particular care must be taken that the victim s airway is maintained open during these procedures and constant checks should be made for gas availability and correct ventilator function 504 1117A 23 Page Intentionally Blank 504 1117A 24 SECTION 3 SET UP AND FUNCTIONAL CHECK a Set Up 1 ventiPAC ventilator Unpack the ventiPAC control module and accessories and check all items against the contents checklist If any items are missing or incorrect or have become damaged notify your supplier immediately If a
42. ed use only the manufacturer s authorised spares WARNING Use of Clausen Harness Section 2 f vii Because the operator is no longer supporting the head and chin particular care must be taken that the victim s airway is maintained open during these procedures and constant checks should be made for gas availability and correct ventilator function 504 1117A 7 16 17 18 19 20 21 22 23 WARNING Functional Check Section 3 b 13 Deviations noted at functional check should be reported immediately to Pneupac and the unit must be taken out of service to avoid the risk of death or serious injury WARNING Pre Use Checks To avoid harm to the patient pre use checks must be performed See Section 3 a and 3 b Points 1 to 8 inclusive before each use WARNING Release of Cylinder Pressure Section 3 b 2 and 3 b 13 To avoid ignition by adiabatic compression connect the ventilator to the regulator before opening the cylinder valve slowly Similarly prior to changing cylinders turn off the cylinder valve switching on the ventilator When the ventilator stops it is safe to release the pin index yoke WARNING Provision of Alternative Means of Ventilation Section 4 Always ensure that an alternative means of ventilation is available in the event of ventilator failure or malfunction WARNING Adequacy of Gas Supply Section 4 b ii To ensure that ventilation can be maintained without interrupti
43. elease the pin index yoke A pressure gauge is provided to check the contents of the cylinder Check level of charge If the gauge indicates empty check that the connection has been made according to above otherwise replace with new cylinder Close cylinder valve Place cylinder into the cylinder sleeve 2 in the Instant Action carrying case and adjust the flaps by means of the Velcro fasteners as required to secure cylinder For the correct positioning of the cylinder see Fig 4 Connect to the control module 3 the threaded end of the input hose 7 and tighten the securing nut lightly using a spanner Connect the patient hose as indicated by the symbols on the side of the module Connect the other end of the patient hose to the fixed side limb of the patient valve see Fig 3 Fit mask onto the taper of the swivelling patient connector limb of the patient valve If two different size masks are provided fit the size most likely to be used NOTE If the ventilator patient hose is incorrectly connected to the swivel connector the ventilator will not deliver any flow to the patient see functional check Section 3 b 5 Insert the probe on the input hose firmly into the bore of the outlet connector on the regulator Make sure the probe is locked into position by gently tugging on the hose 504 1117A 26 b 4 Attach control module to side of case by means of the two thumb screws provided Coil hoses neatly so that case c
44. eneral waste 504 1117A 57 Page Intentionally Blank 504 1117A 58 APPENDIX B Calibration Accuracies and Deviations due to Change in Ambient Conditions 504 1117A 59 Page Intentionally Blank 504 1117A 60 APPENDIX B CALIBRATION ACCURACIES AND DEVIATIONS DUE TO CHANGE IN AMBIENT CONDITIONS WARNING It is essential that where this equipment is used in extreme environmental conditions outside those specified in this manual the operator must exercise particular patient vigilance since although this may not lead to a safety hazard performance will become more uncertain as conditions become more extreme ventiPAC 200D Deviations due to changes in ambient conditions Accuracies of Calibrated Controls Parameter Ambient Ambient Ambient pressure Ambient pressure Factory Calibrated to Further Deviation before temperature 40 C temperature 10 C 110kPa within re calibration necessary Inspiration time Expiration time l eR a E IS temp temp pressure pressure ANI 1 1 5 4 7 7 8 6 Relief Pressure NAM NES 15 upto a 5 upto a maximum of AM lt 2 5 x 100Pa lt 6 x 100Pa lt 3 x 100Pa lt 4 x 100Pa maximum of 2x 100Pa 6 x 100Pa Inflation pressure monitor lt 1X WEN 1 5 x 100Pa lt 1X PRE lt 1 x 100Pa 2 x 100Pa 8 of reading Oxygen 10 points 1 points 5 1 points 1 point concentration Notes Tolerances on the Tidal Volume the nominal figures on the inst
45. entilators with the EP option must never be used without the sensing line attached as this will result in a loss of delivered volume to the patient 7 Supply Gas Failure Alarm This mechanically operated visual alarm gives a warning that the supply gas has dropped to a pressure at which the ventilator will no longer be operating to specification With low pressure it shows red with adequate pressure it shows white Any visible red indicates that the supply should be changed In most cases the display will begin to oscillate from white to partial red as the supply pressure falls to the lower threshold level The visual indication will be accompanied by an electronically generated medium priority audible warning In order to conserve the battery if this audible alarm is ignored for more than 60 seconds the alarm system will ultimately switch itself off 8 High Inflation Pressure Alarm An audible alarm is provided to signal that the relief pressure has been achieved and that gas loss is occurring through the relief valve The alarm is pneumatically operated by means of the gas vented through the relief valve The pneumatically operated alarm is backed up by a high priority electronically generated audible and visual alarm The electronic audible alarm only sounds after alarm pressure has been maintained for a period of 1 0 second in order to avoid the simultaneous sounding of both alarms during transient pressure events Initially the vi
46. er full Mounting Brackets Threaded Bushes M5 x 1 0 x 7mm deep Autoclaving Temperatures Detachable breathing circuit components maximum of 134 C Weight of Patient Valve 50g Patents This product is covered by the following patents UK 2 174 760B EP 0343818 EP 0343824 amp EP 0342883 Standards EN794 Lung Ventilators Part 3 Particular requirements for Emergency and Transport Ventilators The unit follows the International Standard for alarm sounds and indication ISO 9703 Electrical Safety to IEC 601 1 Internally powered Type B equipment EMC to EN60601 1 2 1 x100Pa 1 02 cmH O or 1 x100Pa 1 cmH20 2 Accuracies c The accuracies to which the ventilation parameters of the paraPAC ventilator are factory calibrated and how these are affected by operating and ambient conditions are tabulated in Appendix B 504 1117A 47 d Terms and Definitions Airway Resistance Pressure drop across airway per unit flow AHA American Heart Association CMV Controlled Mandatory Ventilation CPR Cardiopulmonary Resuscitation Comprehensive standards and guidelines for this procedure are given by the American Heart Association in the Journal of the American Medical Association JAMA 6 June 1986 Vol 255 No 21 Demand Valve A valve which delivers gas to the patient at a flow related to the inspiratory efforts of the patient
47. f the magnet 504 1117A 51 iv v vi vii Imaging Tests Imaging tests were performed using the body gradient set with either head or body RF coils transmit and receive A tissue mimetic phantom was placed inside the head RF coil to simulate a person s head This consisted of a Perspex cylinder filled with a copper sulphate and salt solution to mimic the electrical properties of the head Effect of switching gradients A standard echo planar pulse sequence was run whilst the ventilator was at the position of maximum gradient switching 1m from the magnetic isocentre This sequence was chosen for its high switching rates and values The maximum gradient value used at this position was 13 3mT 566396Hz EPI alternates from high positive gradient to high negative gradient in 452us giving a switching rate of 29 43T s 1253Hz us This process is repeated after 214us with the polarity switching again This was run continuously whilst observing the ventilator No effect due to magnetic field switching could be detected Effect of RF fields A standard inversion recovery spin echo sequence was run with the ventilator at the edge of the RF coil This sequence was chosen because of its high RF load 0 4W kg for the head coil and 0 82W kg for the body coil No effects were seen due to interaction of the system RF with the ventilator Image quality A standard spin echo sequence employing both transverse and coronal vie
48. for precautions in MRI use i Switch ventilator off by selecting Demand on the main pneumatic switch 11 Remove the battery retaining cap situated on the right hand side of the control module by twisting a quarter of a turn anti clockwise using a coin in the slot provided iii The battery will be automatically pushed out of its holder iv Fit the replacement battery base first into the holder The positive cap must be showing outwards v Replace the battery retaining cap by pushing it against the battery and twisting clockwise until it stops after a 1 4 turn The cap is reversible so ensure that the marking on the outside of the cap corresponds to the battery being used See section 2 c 15 504 1117A 39 vi Select CMV Demand on the main pneumatic switch and check that the alarm system runs through the start up self checking procedure See section 3 b 5 If the battery failure alarm operates indicated by a medium priority audible and visual alarm whilst ventilating a patient and it is considered necessary to maintain the electronic monitoring then the above procedure should be followed but care should be taken to minimise the time that ventilation is interrupted It should be remembered that battery failure does not affect the operation of the ventilation functions nor the effective operation of the pneumatic alarms and safety devices d Servicing If the ventiPAC ventilator shows a malfunction during
49. his switch is open supply gas flows to the pressure regulator 4 where it is regulated to 2 75 bar before being fed to the main oscillator The oscillator is an integrated miniature pneumatic device which switches the flow on and off at a frequency controlled by the setting of the precision needle valves 6 and feeds the two coupled flow control needles 13 amp 14 If the Air Mix mode is selected the switch 16 is in the off state and gas passes through needle 13 to the nozzle of the entrainment device 15 Ambient air is entrained and drawn in through port 19 via non return valve 17 and the resultant gas mixture is fed to the patient valve through the output connection 10 The flow of gas is controlled by the setting of needle valve 13 When the No Air Mix mode is selected switch 16 is open and driving gas can also pass through needle valve 14 and into the entrainment port of 15 This valve is so adjusted that its flow always matches the entrainment requirements of the mixing device and in this way 100 driving gas is fed to the patient The inspiratory and expiratory time control knobs are connected to needle valves 6 and together control the cycling frequency of the oscillator The inspiratory flow control knob is connected to the coupled needles 13 and 14 to control the flow to the patient Inflation pressure is limited by the setting of the spring loaded variable relief valve and is measured and displayed by the inflation pressure monitor
50. ic compression connect the ventilator to the regulator before opening the cylinder valve slowly Similarly prior to changing cylinders turn off the cylinder valve switching on the ventilator When the ventilator stops it is safe to release the pin index yoke PRECAUTION It is recommended that the valve on the gas cylinder is turned off after use to ensure that the cylinder contents are not lost during storage due to small leakages 504 1117A 29 Page Intentionally Blank 504 1117A 30 SECTION 4 OPERATION a b 1 WARNING Always ensure that an alternative means of ventilation is available in the event of ventilator failure or malfunction WARNING Extreme environments may impair ventilator performance see Appendix B operator vigilance is required to monitor the patient User s Skill See Summary Statement Section 1 a WARNING All operators who are not medically qualified should receive full and proper instruction from a qualified person both on resuscitation and on detailed use of the equipment in the particular situations in which it might be employed see Section 1 a Setting of Ventilator General 11 The ventilator should always be left with the controls set in the position specified in the functional check Section 3 b to enable it to be brought into use with a minimum of re adjustment It should be stored with a suitable gas source or suitable wall outlets must be known to be availa
51. inder WARNING To avoid ignition by adiabatic compression connect the ventilator to the regulator before opening the cylinder valve slowly Similarly prior to changing cylinders turn off the cylinder valve switching on the ventilator When the ventilator stops it is safe to release the pin index yoke If connected to a cylinder regulator turn on cylinder valve slowly NOTE The gas source must be capable of maintaining a pressure of at least 305 kPa 3 bar whilst delivering a flow of 65 L min Check that the visual alarm for supply gas failure has changed from red to white 504 1117A 27 10 11 12 Switch the main pneumatic switch to CMV Demand The ventilator should commence cycling and all the alarm lights flash in turn A single burst of the high priority audible alarm is given at the same time The orange silencing indicator should flash for 60 seconds Check that the flow is coming from the patient connection port by feeling the flow when placed close to the back of the hand or to the face Occlude the output port on the patient valve and check that the manometer gives a reading of between 30 and 50 x100Pa 30 and 50cmH20O during each inspiratory phase The pneumatic audible alarm should also sound accompanied by the high inflation pressure visual alarm After occlusion for one second once the silencing period has elapsed the high priority electronic audible alarm will also sound Check that the unit cycles regular
52. infectant but it must not be immersed d Sterilisation CAUTION To avoid damge to the EP circuit detach all EP Circuit parts from the Patient Hose prior to autoclaving DO NOT autoclave EP Accessories The ventiPAC control module and non patient circuit accessories cannot be sterilised The components of the patient circuit may be steam sterilised after disassembly Remove all EP Circuit parts from the patient hose The patient circuit can be treated up to 134 C These components may also be sterilised by gas sterilisation following the manufacturer s recommendations carefully The ventiPAC control module cannot be sterilised e Reassembly and Function Testing After cleaning or sterilisation parts must be carefully dried and then reassembled Before putting the system back into service the functional check described in Section 3 b should be carried out 504 1117A 38 SECTION 6 MAINTENANACE a General Because of the high reliability and long life of the control elements used the ventiPAC does not require any specific planned servicing Service is only required if calibration needs to be restored if component failure occurs or if damage is incurred It is recommended that maintenance is carried out at two levels At the first level the procedure specified in Section 3 b should be followed at regular intervals typically once a month irrespective of use and a record kept by the use of the log sheet at the back of
53. ion BE High Pressure Audible Alarm Pneumatic Gas passes through the alarm whenever the pressure in the _ ventilation breathing system exceeds the setting of the pressure relief valve CPR Setting This symbol indicates the settings that should be used in order to perform cardiopulmonary resuscitation following AHA Guidelines Chemical symbol for oxygen Qmax Maximum Flow Requirement This symbol denotes the maximum flow requirement at the minimum input pressure en Connection Points for EP Option A e This symbol shows connection points for the external pressure sensing line See section 2 d 1 2 and Figure la Y Supply Gas Failure Alarm This symbol identifies the pneumatically operated supply gas failure visual alarm Any visible red indicates a low supply pressure or a restrictive supply This is accompanied by a medium priority audible alarm A IEC 601 1 Internally Powered Type B equipment defines the degree of electric shock regarding allowable leakage currents Caution Refer to User s Manual before use Audio Alarm Silenced Indicator This orange light flashes once every 3 seconds during the 60 second silenced period to indicate that the electronic alarm is in its silenced state X vV Breathing Detect Indicator This green light flashes for 1 10 second to indicate when a demand breath has been registered by the demand detector within the transPAC ventilator
54. ion below ventiPAC 200D VENTILATOR Time cycled ventilator with synchronised minimum mand ntilation for intermitte b patients and pr e t ADULT CHILD INFANT above 10kg Not to be used on unattended p Basic Instructions 1 Connect to gas supply and switch ventilator to CMV Demand Check pressure indicator 9 indicates low supply 2 Set breathing parameters to suit the patient Set to No Air Mix for respiratory arrest e CPR t O in contaminated atmospheres Set Relief Alarm Pressure to 40 x100Pa Temporarily occlude patient connection to confirm relief pressure and alarm function Connect mask or endotracheal tube Apply in correct manner Check for air tightness and adequate chest movement adjusting flow control ifnecessary Check correctness of indicated airway pressure High pressure alarm may indicate O excessive tidal volume Protected by Patents in which it might be employed personnel in life support in accordance with the is provided on the control module see Table 1 incorrectly positioned airway kinked endotracheal tube Low pressure alarm may indicate O leakage 0 tidal volume insufficient 8 To conserve gas suppl atmospheres select Air Mix in clean with CY 1 min tE 14 2 TIDAL VOLUME Refer to User s Manual before use and for guidance further instructions CMV Controlled Mandatory Ventilation t CPR Cardiopulmonary Resuscitation
55. ipment must be authorised by the Aviation Authority and the Aircraft Operator b General Description WARNING Use of CMV Demand Facility Because this function has characteristics specific to this range of ventilators it is important that the sections of the operating instructions describing this facility Sections 2 b and 4 d are read before this version of the ventiPAC ventilator is used so that the operator understands how the ventilator interacts with the patient during spontaneous breathing The ventiPAC ventilator consists of a control module and a remote patient valve connected by means of a spirally reinforced hose See Fig la A description of controls and features on the ventiPAC ventilator is given in Section 2 a the number reference against each description corresponds to the number reference shown in Figure la The ventiPAC ventilator is a gas powered time cycled ventilator which depends solely on the pressure of the supply gas for its operation The models described in this Manual additionally incorporate an integrated electronic pressure alarm unit to alert the user to certain significant changes which may occur in the patient s ventilation Loss of battery power for the alarm is signalled to the user but will have no effect on the ventilation performance of the ventiPAC ventilator nor affect the mechanically operated alarms and protection systems See Terms and Definitions Section 8 d 504 1117A 11 The cont
56. ly about every 5 seconds Switch over to Air Mix and repeat step 6 The change in the manometer reading should not exceed 5 x100Pa 5cmH 0 NOTE After the 60 second initial silenced period the electronic audible alarms will operate 1f an alarm condition persists These can be silenced for as long as required by depressing the silencing button each time the silencing indicator switches off Set the Flow control to its minimum setting Occlude the output port and check that at least 20 x100Pa 20cmH20 pressure is attained on the manometer Gradually increase the flow setting and observe how the pressure rises demonstrating the pressure generator principle At the 0 25 L sec setting the pressure should be attaining the nominal set value Reset the Flow control to its minimum setting and select No Air Mix Occlusion of the output port should now cause the manometer to rise sharply to between 30 and 50 x100Pa 30 and 50cmH20 and the alarms should operate Allow the ventilator to cycle with no obstruction at the output port and check that the low inflation pressure disconnect alarm operates after 10 seconds Set the Ty Te and Flow control knobs to the extremes of their range By listening to the gas flow check that the ventilator is responding to the controls and that no irregularities of performance can be discerned If the ventilator is likely to be used with small infants the following additional test should
57. m f Indicated Priority of Audible Alarm Sounds High Priority Two bursts of five pulses of sound repeated at the rate of 6 times per minute while the alarm condition persists in accordance with ISO 9703 Medium Priority One burst of three pulses of sound repeated at the rate of 6 times per minute for 60 seconds During the next 60 seconds the rate increases progressively to 12 times per minute 504 1117A 50 g i ii iii MR Compatibility Tests Although the ventiPAC 200D has been assessed to be MR Compatible under the conditions specified in the labeling the following detailed test information is provided to assist the user in ensuring suitability of the device for their specific environment with a minimum of additional testing Test information Equipment All tests were carried out on a Bruker 3T actively shielded MRI system with internal gradient bore of 63cm diameter situated in the Wolfson Brain Imaging Centre Cambridge UK The frequency of this machine is 125 5MHz A ventiPAC 200D was used as a representative test model for these type tests as it uses magnetically identical parts to those of the devices covered by this manual The ventilator was set to operate ventilating a test lung with the relief valve and high pressure alarms just operating at the end of the inspiratory phase Inspiratory and expiratory times frequency and peak inflation pressure were continuously monitore
58. mentarily turn on cylinder using cylinder valve key wheel to blow out any dust in cylinder valve Fit regulator and yoke 1 to the cylinder valve making sure the sealing washer is in position and the two foolproofing locating pins are entered in the side of the square cylinder valve Tighten the T screw in the yoke making sure that the screw s pointed end is in the recess of the cylinder valve Where a regulator with a threaded cylinder connection fitting is provided screw the fittings onto the threaded connection of the cylinder tightening with the regulator in the correct orientation to fit the case Slowly turn on cylinder using the cylinder valve key wheel Open cylinder by two anti clockwise turns of the cylinder valve wheel Check that gas does not leak audibly from the connection or from the gland nut on the cylinder valve If leaking check that the previous fitting instructions have been carried out properly and that the sealing washer is in position and is not damaged If the leak is not rectified replace the cylinder and defer the faulty cylinder via the normal reporting channel 504 1117A 25 Figure 4 Contents of Instant Action Set option and correct stowage WARNING To avoid ignition by adiabatic compression connect the ventilator to the regulator before opening the cylinder valve slowly Similarly prior to changing cylinders turn off the cylinder valve switching on the ventilator When the ventilator stops it is safe to r
59. n return valve to ensure that the patient always inspires from the ventilator and not directly from the atmosphere through this port See Fig 1c WARNING The patient valve is specially modified to match it to the performance of the ventiPAC ventilator and only valves supplied with the units or bearing the specified part number should be used Any other valve may compromise the ventilation performance of the ventiPAC ventilator 504 1117A 19 21 Inlet Connection A compact screw type input connection is provided which is specifically designed to take the input hose provided by Pneupac to make a permanent connection Alternative gas specific user detachable connections can be provided by Pneupac if specified at the time of ordering 22 Input Hose A range of input hoses is available with alternative connections and probes to suit different gases and Standards requirements 23 Carrying Sling Attachments Slots The carrying sling W7140 is attached to the control module by means of slots as shown in Fig 1b 24 Mounting Attachment Points Six M5 x 1 0 x 7 deep female threaded bushes on the back of the control module may be used for the attachment of brackets for direct mounting e Options Covered by this Manual i Model Option Direct patient inflation pressure sensing EP option As explained in Section 2 c 6 ventilators supplied against the suffix EP are arranged to sense the patient inflation pressure directly a
60. nd alternative masks Lightweight aluminium compressed gas cylinders are available from Pneupac for use with portable ventilators The D sized version is suitable for use with the Instant Action Case but it is flat based which permits free standing use also i Instant Action Case the scene of an emergency ii Gas Cylinders Gu Cylinder Regulators The Pneupac lightweight aluminium regulator is designed to reduce the pressure of high pressure gas cylinders from 137 200 x100kPa 137 200 bar to 400kPa 4 bar as required by the ventiPAC ventilator It will deliver flow in excess of 60 L min at this nominal pressure Pin index or other standard inlet connectors are available for air or oxygen The regulator is equipped with a protected contents gauge and a gas specific quick release outlet connector which accepts the BS probe on the ventiPAC input hose Patient Valve Fixed Side limb yyy Patient Hose Exhaust Collector Patient Connector PEEP Valve Figure 3 Connection of the patient valve PEEP valve Exhaust collector accessories 504 1117A 22 iv Oxygen Therapy Unit The Pneupac Oxygen Therapy Unit consists of a flow regulating 2 metre lead with a built in filter and disposable face masks The lead connects to the cylinder regulator outlet connector and delivers 6 litres per minute of oxygen to the mask whose design ensures that the patient receives approximately 40 45 oxygen in the mask This lea
61. neceeensenecnsensoneeteeneenes 36 Figure 5 Principle of operation of the demand version of the ventiPAC ventilator eee 43 Pneupac reserves the right to make changes without notice which may affect the information contained in this manual Trademarks The names Pneupac ventiPAC ventiPAC 200D Instant Action and Smiths are registered trademarks of Smiths Group plc 504 1117A 4 SECTION 1 SUMMARY STATEMENT The ventiPAC 200D ventilators are portable devices intended for the ventilation of adults children and infants above 10kg during transportation and emergency situations They consist of a control module and a remote patient valve connected by means of a breathing hose Both pneumatic and electronic alarms are incorporated WARNING Failure to read this User s Manual before first use of this device may result in death or serious injury Before use for the first time all potential users must read the complete User s Manual they should also familiarise themselves with the machine and its operation to enable them to use it effectively They should study the contents of this Manual to the extent required to supplement their training Special attention must be paid to warnings and precautions which are summarised in section 1 b Failure to observe these warnings and precautions could compromise patient and or user safety Special guidance on the operation and use of the ventilator is given in section 4 of this manu
62. ngths of smooth bore patient hose of the type supplied with the ventilator using suitable connectors Corrugated hosing is not generally recommended because the increased compliance will affect the volume calibration of the ventilator particularly for smaller patients It is also more susceptible to kinking and inadvertent flattening All parts which contain metals and which are MR Compatible are marked MRI on their packaging and where this feature is required for additional parts and accessories MRI should be added as a suffix to the order code of each part ordered See Section 7 WARNING To prevent possible risk of projectile injury within a MRI environment routinely check for magnetic attraction WARNING When in use in an MRI environment to prevent injury to the patient check the pressure manometer to confirm unchanged ventilation Also test the high pressure relief alarm system by temporary circuit disconnection and occlusion of the ventilator outlet connector both whenever the system is taken into a MRI environment and every time the patient is positioned within the magnetic field 504 1117A 33 i User Information Label Table 1 WARNING All operators who are not medically qualified should receive full and proper instruction from a qualified person both on resuscitation and on detailed use of the equipment in the particular situations The ventiPAC may be used by fully trained ILCOR 2000 guidelines Basic informat
63. ntilator is used so that the operator understands how the ventilator interacts with the patient during spontaneous breathing Selection of CMV Demand also switches on the electronic alarm but for the first 60 seconds of the ventilator operation most of the alarm functions are automatically suspended in order to allow time to apply the ventilator to the patient Selection of Demand switches off the alarm unit 4 Relief Pressure Control This rotary control knob gives continuous adjustment of the maximum patient inflation pressure by setting the relief valve spring loading It is calibrated to facilitate initial setting but as the peak pressure will also have some dependence upon other parameters the inflation pressure monitor should always be used as the final reference 5 Air Mix Control This knob operates a rotary two position switch to select the Air Mix or the No Air Mix mode In the No Air Mix position the gas supplied to the ventilator is passed undiluted to the patient whether this be 100 oxygen or compressed air In the Air Mix mode the ventilator uses a high efficiency entrainment device to mix ambient air with the supply gas in the ratio of approximately 2 1 When supplying oxygen this means that a mixture containing 45 oxygen is generated and supplied to the patient When air is used as the driving gas no change of gas composition occurs but advantage can be taken of the 70 reduction in driving gas consumption
64. on keep a constant check on the adequacy of gas supply by observing the gas cylinder contents indicator and the gas failure visual alarm WARNING Interpretation of Breathing Detect Indicator Section 4 d Actuation of the breathing detect indicator only indicates that spontaneous breathing has been detected and that the low pressure alarm has been reset as a consequence The operator must still ensure that patient ventilation is adequate WARNING Use in Contaminated Atmosphere 1 Section 4 g The ventiPAC ventilator models are suitable for use in contaminated and toxic atmospheres subject to certain limitations as described below and these should be clearly understood by those likely to use the equipment in such environments so that it is only used where appropriate WARNING Use in Contaminated Atmosphere 2 Section 4 g In any situations where the respirable qualities of the immediate environment are suspect ventilation should only be carried out in the No Air Mix mode This ensures that only a minimum of ambient gas can enter the breathing system 504 1117A 8 24 25 26 27 28 WARNING MRI Use Section 4 h To prevent possible risk of projectile injury within a MRI environment routinely check for magnetic attraction When in use in a MRI environment to prevent injury to the patient check the pressure manometer to confirm unchanged ventilation Also test the high pressure relief alarm
65. ore only lithium batteries can be used Other batteries will fail to operate the alarm system 504 1117A 45 b Technical Data Principle of operation The ventilator is a time cycled volume preset pressure limited flow generator setting It acts as a pressure generator at flow settings below 0 25 L s with the Air Mix The ventiPAC 200D incorporates a patient demand valve and a ventilation inhibit function which becomes operative when an adult patient breathes at an adequate level Power Source Gas specific terminal outlet providing dry oil free filtered gas within the pressure range 305 to 600 kPa at 65 L min This ensures a minimum pressure of 280 kPa at the ventilator input ports with allowance for supply hose pressure drop As standard the ventilator is calibrated for use with oxygen Frequency Range 7 to 60 b min Flow Range 6 to 60 L min Inspiratory Time Range 3 0 to 0 5 seconds Expiratory Time Range 6 0 to 0 5 seconds Flow Range 0 1 to 1 0 L sec 6 to 60 L min Breathing parameters derived from control settings Tidal Volume 3000 to 50ml Minute Volume at I E 1 2 20 to 2 Litres VBS Inspiratory Resistance 4 5 x100Pa 4 5cmH 0 at 60 L min 3 x100Pa 3cmH 0 at 30 L min Expiratory Resistance 3 5 x100Pa 3 5cmH 0O at 60 L min 1 5 x100Pa 1 5cmH 0 at 30 L min Compliance 12 mL kPa Internal volume 270 mL LE
66. oth Do not attempt to sterilise the control module or to clean it by immersion in any fluid Do not allow any oil or grease to come into contact with the module or in particular with the input and output fittings because of the potential fire risk when oxygen is being used 11 Patient valve Disassemble the patient valve by unscrewing the two parts of the body and carefully removing the yellow valve element also the yellow annular disc surrounding the patient connector Thoroughly clean each of the parts either in running hot water or in a detergent solution followed by thorough rinsing under running water Scrub the rigid plastic parts 1f necessary but not the yellow rubber parts Dry all the parts thoroughly and check them for damage before reassembly Ensure that the yellow valve element is inserted the correct way round and is not distorted when the valve halves are re screwed together 11 Hoses The supply hose may be cleaned in the same manner as the control module taking the same care to keep free from grease The patient hose may be cleaned in the same manner as the patient valve parts 504 1117A 37 c Disinfection After cleaning the patient valve components and the patient hose may be disinfected by immersion in a cold solution of disinfectant or germicide Rinse and carefully dry all components before reassembly Consult the manufacturer for any specific instructions The control module may be wiped with a dis
67. patient valve any spontaneous breathing effort is satisfied by flow from the demand valve This provides a very gas efficient method of treating a victim where 100 oxygen is recommended as the approved therapy and can also be used to protect a spontaneously breathing patient during rescue from a contaminated atmosphere The control module is designed to be mounted in a variety of ways as described under Section 2 d ii Mounting Options A sling is available to enable the unit to be carried from the user s shoulder It may also be carried together with a compressed gas cylinder within a Pneupac Instant Action carrying case A wide range of attachments and brackets is also available The ventiPAC ventilator may be driven by oxygen or air from a compressed gas cylinder pipeline system or one of the airPAC portable compressors 504 1117A 12 c Figure la Front view of ventiPAC showing accessories features and the EP option Contraindications None known d 1 Controls and Features Figures la and 1b Controls for Inspiratory and Expiratory Times These calibrated rotary control knobs give continuous adjustment of time over the range of 0 5 to 3 0 seconds for inspiration and 0 5 to 6 0 seconds for expiration Together these controls set the breathing frequency which can be calculated as 60 TI TE e g if the inspiratory time is set to 0 75 second and the expiratory time 1 25 seconds then the frequency is 60 1 25 0
68. pressure Higher supply pressures will slightly decrease the sensitivities Output Connection 22 15mm co axial taper Patient Circuit 1 2m long 15mm single bore polyester hose with autoclavable patient valve Power Source Replaceable 3 3 6volt lithium battery Two options Size 123A for general use widely available camera battery Size AA special low magnetic battery for MRI and general use Pneupac part number W269 023 Battery Life Shelf life 10 years In general use in excess of 1 year Supply Gas Input Connectors G 1 4 connection intended for the permanent connection of the input hose Gas specific connectors for use with user interchangeable hoses are available if specified Input Hoses Standard 1 5m long 6mm bore with probe to BS 5682 oxygen as standard Alternatives available Minimum demand to inhibit ventilator flow 15 L min tidal volume 450ml nominal at 12 b min Low Pressure Disconnect Alarm An alarm signal is generated if patient pressure does not rise through the low pressure setting of 10 x100Pa at least once in 10 seconds Alarm silenced Alarm silenced for 60 seconds duration visually indicated Dimensions Control Module 92H x 220W x 162D mm Dimensions Instant Action Case 247mm H x 245mm W x 615mm L Weight of Control Module 3 1kg Weight of Instant Action Case 10 kg complete with ventiPAC 200D and D sized cylind
69. re Sensing EP Option 2 Section 2 d i and 2 d 6 Ventilators with the EP option must never be used without the sensing line attached as this will result in a loss of delivered volume to the patient and loss of patient pressure indication on the manometer WARNING Battery for MRI Use Section 2 d 15 To avoid projectile risk in a MRI environment use only the approved MRI compatible battery Part No W269 023 Do not attempt to remove the battery from the ventilator or take a loose battery in a MRI environment Section 2 d 15 To prevent possible risk of projectile injury within a MRI environment routinely check for magnetic attraction WARNING Potential Unsatisfactory Performance with Alternative Ventilator Patient Circuits Section 2 d 18 Failure to use approved circuits and accessories may lead to unsatisfactory ventilator performance WARNING Special Patient Valve Section 2 d 20 The patient valve is specially modified to match it to the performance of the ventiPAC ventilator and only valves supplied with the units or bearing the specified part number should be used Any other valve may compromise the ventilation performance of the ventiPAC ventilator WARNING Provision of Accessories Ancillaries and Spares for CE marked products Section 2 f 6 d amp 7 The ventiPAC ventilator is manufactured and CE marked to the requirements of 93 42 EEC To ensure that this equipment functions as intend
70. re not going to use for a long time ALWAYS keep batteries away from small children If swallowed seek medical advice immediately and contact the subsidiary of the battery manufacturer in you country NEVER deliberately short circuit batteries NEVER take apart crush puncture or mutilate lithium batteries NEVER bring a damaged cell in contact with water Lithium metal reacts vigorously with water producing flammable hydrogen gas which can cause a fire PRECAUTIONS FOR STORAGE Batteries should be stored at temperatures between 10 C and 25 C with relative humidity not exceeding 65 To maximise shelf life excessive temperature cycling and storage at temperatures greater than 25 C should be avoided Storage of lithium batteries at lower temperatures is possible providing care is taken in returning the batteries to room temperature prior to use Store unused batteries in their packaging and keep away from metal objects which may cause short circuit resulting in possible leakage or in extreme cases an explosion CHARGING WARNING Lithium batteries are of the primary type and are NOT designed to be recharged Attempts to recharge these batteries can lead to leakage and possibly an explosion No responsibility is accepted by the manufacturer for injury or damage resulting from the cells having been recharged or otherwise abused 504 1117A 55 IF PART OR WHOLE OF THE BATTERY IS SWALLOWED SEEK MEDICAL ADVICE IMMEDIATELY Note
71. rol module of the ventiPAC ventilator is rugged by virtue of its thick section structural foam plastic case and the use of anti shock mountings for the gauge internal pneumatics and electronics The controls are recessed to minimise the possibilities of damage Calibrated controls for inspiratory time expiratory time and inspiratory flow are provided to set the required ventilation pattern An adjustable pressure relief device with an audible alarm limits the peak inspiratory pressure to the set value An air mix control gives an FiO option of 0 45 or 1 0 For longer term ventilation the 0 45 FiO setting will normally be used and in this setting gas consumption is significantly reduced by almost 70 giving greatly extended cylinder duration or allowing the use of a much smaller compressor if compressed air is used as the driving gas On the ventiPAC 200D ventilator selection can be made between Demand or CMV Demand When CMV Demand is selected the ventilator cycles at the set frequency but if a spontaneous breath is taken during an exhalation phase then this is taken from an internal demand valve If breathing is at an adequate level for an adult cycling will be inhibited as long as this breathing level is maintained If breathing becomes inadequate CMV will be restored synchronised with the last breath When Demand is selected only the internal demand valve is energised by the gas supply When the patient is connected to the
72. ruction label as detailed in Table 1 page 36 are a combination of T and Flow The Tidal Volume delivered can be adjusted by trimming T or Flow If the Tidal Volume accuracy is important it is recommended that this parameter is monitored independently during use Volumes are quoted as measured at local conditions and at STP conditions of 20 C 101 3 kPa Variations in Humidity do not cause deviations in performance AM refers to Air Mix setting NAM refers to No Air Mix setting These parameters calibrated with 15 x100Pa 15cmH 0 backpressure at the patient connection 504 1117A 61 ventiPAC Mean inflation Pressure x100Pa or emPO 5 10 15 20 25 30 60 Equivalent Peak Inflation Pressure with 10 due to pressure drop in 9 18 27 36 45 55 110 airway x100Pa or cmH O Equivalent Peak Inflation Pressure with 50 due to pressure drop in 7 13 20 27 33 40 80 airway x100Pa or cmH 0 3 A A A A A A A o A Tidal Volume Setting Vr O Vr O Vr O Vr O Vr O Vr O Vr O Vr O 1 0 4 45 3 46 2 47 0 47 2 47 4 48 6 48 12 51 i 0 75 10 44 6 45 3 45 0 46 2 47 35 48 8 49 26 56 With Rea 0 5 20 45 13 46 7 47 0 48 7 50 14 52 21 55 66 97 pelecied 0 25 62 46 40 48 422 53 o so 22 68 44 84 58 100 58 100 0 1 97 46 58 56 0 71 46
73. sorbed or neutralised by other materials in the battery The lithium batteries recommended in this Manual are covered by this exemption from the above international regulations For restrictions applying to individual countries the relevant regulatory authority should be consulted 504 1117A 56 REFERENCES 1 Dangerous Goods Regulations Montreal International Air Transport Association 1993 Ze European Agreement Concerning the International Carriage of Dangerous Goods by Road ADR 1993 Edition London HMSO 1992 3 Regulations Concerning the International Carriage of Dangerous Goods by Rail RID 1990 Edition London HMSO 1989 4 International Maritime Dangerous Goods Code London International Maritime Organisation 1992 DISPOSAL DISPOSAL PROCEDURES As they contain no mercury lead or cadmium the disposal of the lithium batteries recommended in this manual is not regulated by European Community Directive 91 157 EEC on Batteries and Accumulators Containing Certain Dangerous Substances However individual countries may also establish regulations that cover the disposal of waste batteries These may be more stringent that EC requirements Thus local regulatory authorities should be contacted for their disposal guidelines In the absence of specific regulations or guidelines the following is recommended for the disposal of lithium batteries Up to five lithium batteries can be disposed of with other g
74. sual alarm only indicates each time the pressure reaches the preset limit but if high pressure conditions persist the alarm latches to give continuous flashing Both the audible and visual alarms reset automatically after 10 seconds when the condition is no longer present See Terms and Definitions Section 8 d 504 1117A 15 9 Cycle Indicator During ventilation of the patient the inflation pressure is continuously monitored by a positive pressure detector pre set to 10 x100Pa 10cmH2O Each time the inflation pressure rises through this set pressure level the green Cycle Indicator flashes for 1 10 second to indicate to the user that at least this inflation pressure is being achieved each cycle 10 Low Inflation Pressure Disconnect Alarm A medium priority audible and visual alarm will operate to warn the user of a possible disconnection in the ventilator breathing system or that the ventilator is not cycling correctly if the inflation pressure generated by the ventilator does not rise through the pre set level of 10 x100Pa 10cmH20 at least once in any 10 second period It should be noted that during normal functioning of the ventilator the generated pressure is always zero during the expiratory phase even if PEEP is applied at the exhalation port of the patient valve Both the audible and visual alarms reset when the alarm condition no longer exists 11 Constant Positive Inflation Pressure Alarm A high priority audible and vis
75. t the patient outlet connection refer to Figure la The sensing port is mounted in an adaptor which couples to the 22mm taper of the patient connection The sensing line is connected between the port and a male connector on the side of the ventiPAC ventilator The line is secured to the patient hose at intervals by means of the clips supplied If used correctly with the PEEP valve the actual PEEP value will be shown WARNING Although there is no net flow in the sensing line it is recommended that a microbial filter is always inserted in the sensing line to ensure that no patient contamination can enter the manometer circuit within the control module WARNING Ventilators with the EP option must never be used without the sensing line attached as this will result in a loss of delivered volume to the patient Gi Mounting Options The ventiPAC ventilator has been designed to be mounted and carried with a wide range of options as shown in Fig 2 It may be mounted with its base or back on a flat surface as shown in Figs 2 a and 2 b Alternatively it can be carried on the shoulder by means of the carrying sling as shown in Fig 2 c 504 1117A 20 N G dl m AO Figure 2a and Figure 2b Figure 2c For more permanent installations ventiPAC ventilators can be fitted with a rail or pole mounting bracket as shown in Fig 2 d and 2 e The brackets are attached to the back of the control module by means of two M5 x 1 0 socket hea
76. tient valve in order to hold a positive expiration pressure at the patient s mouth at the end of the expiratory phase Positive End Expiration Pressure PEEP PEEP Positive End Expiratory Pressure Pressure in the breathing circuit is maintained at a set positive pressure throughout the expiratory phase Pressure Generator The ventilator delivers ventilation by establishing a constant set pressure at the patient connection throughout the inspiratory phase The resultant flow into the lungs is determined by the compliance of the patient s lungs and the resistance of the airways Relief Valve Valve which limits the maximum patient inflation pressure by venting excess gas to the atmosphere EL Tidal Volume V___ TD Volume of gas delivered to the patient during an inspiration phase VBS Ventilator Breathing System The breathing system connected to the patient connection port and bounded by the exhaust port and the air entrainment device 504 1117A 48 e Explanation of Symbols and Alarm Condition Indicated SD a Inflating Gas Input Port Connector Compressed gas entering this port is delivered to the patient after its pressure energy has been used to power the ventilator Gas Output Port Connector Da att Pa The transPAC ventilator breathing system supplied with the attt ventilator is attached to this connector to transfer ventilating gas from the ventilator to the patient connect
77. tion Time Expiration Time and Flow 17 Alarm Information Label This label provides alarm battery information and a key to alarm signals 504 1117A 18 INSPIRATION EXPIRATION 18 19 20 Detachable part of Ventilator Breathing System for model 200D Connection t a Ventilator Patient Hose Patient inspired gas i Expired gas to atmosphere Expired gas from patient Figure 1c Detachable part of ventilator breathing system for demand version Patient Outlet Connection This outlet to the patient from the ventilator is intended for the attachment of the patient circuit supplied by Pneupac for this purpose WARNING Failure to use approved circuits and accessories may lead to unsatisfactory ventilator performance Patient Hose The patient valve is connected to the control module by means of a spirally reinforced smooth bore ventilation hose It may be autoclaved at temperatures up to 134 C See Section 5 d Patient Valve This valve directs the inspiratory flow from the ventilator into the lungs during the inspiratory phase and allows expiration to the atmosphere The connection to the patient is by means of an 22 15mm co axial taper fitting so that face masks or endotracheal tubes conforming to the requirements specified in EN 1281 1 may be used It may be autoclaved at temperatures up to 134 C On Model 200D ventilator the yellow rubber disc covering the expiratory port serves as a no
78. ual alarm will operate to warn the user of a possible danger to the patient if the inflation pressure remains at a positive pressure above the preset pressure threshold of 10 x100Pa 10cmH20O but below the set Relief Pressure for a period exceeding 10 seconds unless this is due to the application of high levels of PEEP 12 Silencing of Electronic Audible Alarms A visual signal consisting of an orange light flashing every 3 seconds is used to indicate when an electronically generated audible alarm has been silenced For the first 60 seconds after switching on the ventilator CMV Demand selected all alarms except the supply gas failure alarm are automatically suspended although high priority visual alarms will still operate Any audible alarm can be silenced for a 60 second period subsequently by depressing the silencing button but if a new alarm condition occurs during this period it will be immediately annunciated If the silencing button is depressed pre emptively i e before any alarm sounds then only a new high priority alarm condition will cause an alarm to sound during the following 60 seconds 13 Breathing Detect Indicator A green visual indicator is used to indicate that a spontaneous breathing effort has been detected by the demand detector in the ventiPAC ventilator Each time detection occurs the low inflation pressure disconnect alarm is reset in the same way as a positive pressure resets the alarm in normal ventilation
79. ws used for daily quality assurance was used to test for any RF interference due to RF emissions from the ventilator No spikes in the images were observed indicating no RF interference Placing the ventilator control module next to the phantom s edge did as would be expected cause a magnetic susceptibility artifact due to the presence of the metallic contents near the imaging volume When the control module was situated at the base of the head cradle 21cm away from the phantom s edge no RF interference or susceptibility artifact was observed 504 1117A 52 APPENDIX A Product Safety Transportation and Disposal of Recommended Batteries 504 1117A 53 Page Intentionally Blank 504 1117A 54 APPENDIX A PRODUCT SAFETY TRANSPORTATION AND DISPOSAL OF RECOMMENDED BATTERIES Lithium Batteries Product Safety Transportation and Disposal PRECAUTIONS FOR HANDLING AND USE Lithium battery cells as recommended for use with this device will provide long reliable and safe service when used correctly To achieve optimum performance and trouble free Operation the following precautions should be observed ALWAYS take care to fit batteries correctly observing the plus and minus signs on the battery and appliance ALWAYS replace batteries in your equipment with the type and size of battery specified by the manufacturer ALWAYS remove dead batteries from equipment and all batteries from equipment your know you a

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