Pneupac babyPAC 100 Ventilator User Manual Issue 3 July 2002

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babyPAC 100 Ventilator User's Manual Table Of Contents Page Number Table Of Contents...2 SECTION 1 SUMMARY STATEMENT...5 (b)

Warnings and Precautions...5

SECTION 2 GENERAL INFORMATION...10 (a)

Intended Use...10

(b)

Contraindications – none known...10

(c)

General Description...10

(d)

Controls and Features (See Figs. 1a & 1b) ...12

(e)

Mounting Options...20

(f)

Accessories...22

SECTION 3 : SET-UP AND FUNCTIONAL CHECK ...24 (a)

Set Up ...24

(b)

Functional Check...24

SECTION 4 OPERATION ...28 (a)

User's Skill ...28

(b)

Setting of Ventilator ...28 (i) General...28 (ii) Ventilating Patient (Refer to Table 1, page 25) ...28

(c)

Humidification ...29

(d)

Manual Ventilation...30

(e)

Gas Usage ...30

(f)

Use with MRI (MR Compatibility) ...30

SECTION 5 CARE, CLEANING & STERILISATION ...32 (a)

Care...32

(b)

Cleaning ...32

(c)

Disinfection...33

(d)

Sterilisation ...33

(e)

Reassembly and Function Testing...33

SECTION 6 MAINTENANCE...34 (a)

General...34

(b)

Performance Checking...34

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(c)

Changing of battery ...34

(d)

Servicing ...35

SECTION 7 ACCESSORIES AND SPARE PARTS...36 SECTION 8 TECHNICAL INFORMATION ...38 (a)

Principles Of Operation ...38

(b)

Technical Data...41

(c)

Accuracies...43

(d)

Terms and Definitions ...44

(e)

Explanation of Symbols...45

(f)

Indicated Priority of Audible Alarm Sounds ...47

(g)

MR Compatibility Tests...47

Appendix A - Product Safety, Transportation and Disposal of Lithium Batteries ...52 Appendix B Calibration accuracies and deviations due to change in ambient conditions ...56 Appendix C - Cleaning and inspection log ...60

Pneupac reserves the right to make changes, without notice, which may affect the information contained in this manual. Trademarks: The names "Pneupac", "babyPAC 100", "Instant Action" and "Smiths" are registered trademarks of Smiths Group plc.

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SECTION 1

SUMMARY STATEMENT

The babyPAC 100 portable ventilator is designed for use in and outside hospitals. It is particularly suitable for ventilation during transportation and for the resuscitation of neonates and infants up to a bodyweight of 20 kg. The babyPAC ventilator consists of a single compact control module with a conventional Y patient circuit. It is a gas powered pressure generator ventilator with pneumatic and electronic alarm systems. Before use for the first time, all potential users should 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 safety. Special guidance on the operation and use of the ventilator is given in section 4 of this manual and basic operating instructions are provided on the label affixed to the control module. WARNING: 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 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 babyPAC ventilator. The babyPAC ventilator is intended only for use in transport and emergency situations where the patient is being constantly monitored 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. (b)

Warnings and Precautions

The following Warnings and Precautions highlight aspects of the use of the babyPAC ventilator that require particular emphasis. The section of this manual referenced in each clause provides the relevant context. WARNINGS 1.

Operator skill and training (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 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 babyPAC ventilator.

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2.

Use of Oxygen (Section 3(a)) Oil, grease or combustible lubricants, other than those approved for oxygen service, must never be allowed to come into contact with the parts of the ventilator, oxygen regulator or cylinder. Particular care should be taken to avoid any trace of contamination around the oxygen inlet and outlet ports. Oil or Grease readily oxidise and in the presence of oxygen will violently burn. Always connect the ventilator to the regulator before opening the cylinder valve and then open the valve slowly in order to avoid the risk of ignition induced by the heat generated by adiabatic compression. Avoid smoking or naked flame.

3.

Use in Aircraft (Section 2(a)) The use of oxygen and electrical systems aboard aircraft is regulated by the relevant aviation authority because of the associated risks of fire, explosion and interference with aircraft systems. Such use, therefore , must be authorised by the authority and the aircraft operator. Particular control is exercised in the selection of devices handling high pressure oxygen such as oxygen cylinders and their pressure reducing regulators.

4.

Battery for MRI Use (Section 2(c)15) In order to avoid any possible projectile risk causing damage or injuryi) ii) iii)

5.

Use only battery supplied by Pneupac and marked “For use in MR Compatible ventilators”. Remove ventilator from MR environment before attempting to change battery. Do not take a loose battery into an MR environment.

Potential Unsatisfactory Performance with Alternative Ventilator Patient Circuits (Section 2(c)18) Circuits of alternative materials may be used but if these circuits have higher compliance ventilatory performance may be compromised. Corrugated disposable hoses are not recommended for this reason.

6.

Provision of Accessories, Ancillaries and Spares for CE marked products (Section 2(e), 6(d) & 7). The babyPAC ventilators described in this manual carry a CE mark to certify that they have been manufactured to conform to the requirements of the European Medical Devices Directive 93/42/EEC. To ensure that this equipment is maintained to the requirements of the Directive, only accessories, ancillaries and spares authorised by the manufacturer should be fitted. All such parts sold by Pneupac have /CE incorporated in their Order Code.

7.

Functional Check (Section 3(b)13) Any deviations observed in the above checking should be reported immediately to your supplier, or an authorised service engineer, and the ventilator should not be used until a more thorough check has been competed.

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8.

Release of Cylinder Pressure (Section 3(b)13) Before changing gas cylinders, turn off the cylinder valve and then switch on the ventilator. After one or two cycles the ventilator will stop and it is then safe to unclamp the pin index yoke without a risk of injury or, in extreme cases, fire due to a sudden release of pressure.

9.

Provision of Alternative Means of Ventilation (Section 4) In accordance with recognised industry practice for all ventilators ensure that, whenever a patient is being ventilated by means of an automatic ventilator, an alternative means of ventilation (eg a manual ventilator) is readily available to use should ventilator failure occur.

10.

Adequacy of Gas Supply (Section 4(b)(ii)) 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.

11.

Care When Using Ventilator for Manual Ventilation The operator must maintain constant observation of the patient pressure manometer during manual ventilation using the ventilator to ensure that over-inflation is avoided.

12.

MRI Use (Section 4(h)) The normal routine of checking the ventilator system for magnetic attraction should be followed whenever the equipment is taken into an MR environment. It is also recommended that every time a patient is positioned in the magnetic field the manometer is checked to confirm unchanged ventilation and the high pressure relief/alarm system is checked by a temporary circuit disconnection and occlusion of the ventilator outlet connector. These procedures are the minimum required in safeguarding against projectile risks or altered performance due to the inadvertent addition of magnetically attracted parts or changed compatibility conditions.

13.

Use in Extreme Environments (Appendix B) Although use of this ventilator outside the environmental conditions specified in this manual will not directly lead to a safety hazard, the performance will become increasingly uncertain as the conditions become more extreme. Therefore the operator must exercise particular patient vigilance under these conditions.

Caution: If the babyPAC ventilator is mounted within a very confined space care should be taken to ensure that the fresh gas intake port is supplied with air that is not contaminated by the expired gas released from the expiratory valve as this will affect the delivered oxygen concentration. If necessary a short length of 10mm bore soft tubing can be connected to the outside diameter of the intake port to duct in fresh air.

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14.

Oxygen Concentration (Section 2(c)) An important safety feature of the babyPAC is that it continues to operate after the failure of one of the supply gases during two gas operation. If both oxygen and air are connected as gas sources then the 21% to 75% concentration (yellow scale) becomes operative. If the compressed air supply is turned off the unit automatically reverts to the 50% to 100% concentration scale (white scale). However an inevitable change of delivered oxygen concentration occurs as indicated by the dual scale calibration. Therefore in the event of medical air supply failure the oxygen concentration should be reset if clinically necessary. If the oxygen supply ceases for any reason, the ventilator will only supply 21% oxygen to the patient, irrespective of the oxygen control setting. The control should always be left at the 21% setting in this mode of operation in order to achieve maximum gas economy.

If only oxygen is available as a compressed supply gas then an oxygen concentration is available within the following range:Note: The pointer on the control knob rotates beyond the 50% marker.

16.

•

Control set to minimum setting (fully anti-clockwise), approximately 45% concentration.

•

Control set to maximum setting (fully clockwise) 100% concetration.

Damaged Patient Circuit Connectors

To avoid harm to the patient, user’s should be aware that it is important to check for damage on the patient circuit connectors as this could adversely effect ventilator performance. PRECAUTIONS: 1.

Protection of Battery and Ventilator During Periods Without Use (Section 2(c)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 function selector switch is left in the ‘O’ (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.

2.

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

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that the cylinder contents are not lost during storage due to small leakages. 3.

General Precautions Relating to Battery Safety, Transportation and Disposal See Appendix A.

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SECTION 2 (a)

GENERAL INFORMATION

Intended Use

The babyPAC 100 portable ventilator is designed for use in and outside hospitals. It is particularly suitable for ventilation during transportation and for resuscitation of neonates and infants up to a bodyweight of 20 kg. These ventilators are extremely economical (See ‘Duration of gas supply’ Section 8b ‘Technical data’ Page 35) in their use of driving gas and the unique air entrainment selectable oxygen concentration facility makes them particularly suitable for the long distant transport of patients using cylinders of oxygen or air. The babyPAC ventilator 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: The use of oxygen and electrical systems aboard aircraft is regulated by the relevant aviation authority because of the associated risks of fire, explosion and interference with aircraft systems. Such use, therefore , must be authorised by the authority and the aircraft operator. Particular control is exercised in the selection of devices handling high pressure oxygen such as oxygen cylinders and their pressure reducing regulators. (b)

Contraindications – none known.

(c)

General Description

The babyPAC ventilator consists of a control module with a conventional Y patient circuit. (See Fig 1a, page 10). It is a gas powered, time cycled, pressure generator* which depends solely on the pressure of the supply gas for its operation. The model described in this manual additionally incorporates an integrated electronic pressure alarm unit which becomes operational during CMV* modes. It alerts the user to certain significant changes which may occur in the patient's ventilation. Loss of battery power for the alarm is signaled to the user but will have no effect on the ventilation performance of the babyPAC ventilator, nor affect the mechanically operated alarms and protection systems. The control module of the babyPAC ventilator is rugged by virtue of its thick section structural foam plastic case and the use of anti-shock mountings for the gauge and internal pneumatics and electronics. The controls are recessed to minimise the possibilities of damage and inadvertent operation. The ventilatory pattern is set by means of independent calibrated controls for inspiratory time, expiratory time and inflation pressure. There is a constant flow through the ventilator breathing circuit during the inspiratory phase of 10 L/min. When ‘CMV+ACTIVE PEEP’ is selected this flow is also maintained during the expiratory phase. A separately adjustable high pressure alarm is provided which gives audible warning if the patient pressure reaches the level set. A pressure relief system limits the pressure at this level. *

See Terms and Definitions, Section 8 (d).

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The unique gas mixing system allows a precise oxygen concentration to be selected which will be delivered irrespective of the inspiratory pressure or tidal volume. If only oxygen is supplied, the concentration can be set between 45 (approx.) and 100% oxygen but if both oxygen and compressed air are available then 21% to 70% oxygen can be selected. With 45% (approx.)/21% oxygen selected 2/3 of the gas supplied to the patient circuit is entrained from the atmosphere, thereby reducing consumption of cylindered gas by the same proportion. Selection of the IMV function increases the set expiratory time by a factor of 10 so that this can be extended up to 40 seconds – allowing time for spontaneous breathing between the mandatory ventilations. PEEP can be set using a control on the ventilator. This has an uncalibrated scale but can be finely adjusted by reference to the actual value as indicated by the patient pressure manometer during ventilation. For the spontaneously breathing patient, airway pressure and oxygen concentration can be controlled using the CPAP function. This function is also automatically introduced during the expiratory phase whenever IMV is selected. The exhalation valve is mounted on the ventilator output manifold and consists of a twistto-remove housing and a silicone rubber valve element. Both items can be autoclaved for sterilisation (see section 5(d)). babyPAC ventilators have been supplied which are suitable for ventilating patients whilst being subjected to MRI procedures. See Sections 4(f) & 8(g) for further details concerning MR Compatibility. All parts which contain metals and which are MRI compatible are marked “/MRI” 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). The control module is designed to be mounted in a variety of ways as described under Section 2 (d) ‘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 are also available. The babyPAC ventilator may be driven by oxygen and/or air from a compressed gas cylinder, pipeline system or one of the airPAC portable compressors.

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(d)

Controls and Features (See Figs. 1a & 1b) 19

20

25

7

10

8

9

14

1a

1b

4

22

5

18

17

11a

12

26

6

16

3

6a 11b Figure 1a 21

23

15

24 13

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Figure 1b

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2

1.

Controls for Inspiratory and Expiratory Times These calibrated rotary controls give continuous adjustment of time over a range of 0.25 to 2.0 seconds for inspiration and 0.25 to 4.0 seconds for expiration. Normally these two controls will be adjusted independently to set the optimum period for adequate inspiration and sufficient expiratory time to allow the alveoli pressure to reduce to the required level. If required, the breathing frequency can be calculated as 60/(TI+TE) eg. if the inspiratory time is set to 1 second and the expiratory time to 1.5 seconds then the frequency is 60/(1+1.5) = 24 bpm. The table on the top label of the ventilator helps to confirm the set frequency rapidly.

2.

Inspiratory Pressure This calibrated rotary control gives continuous adjustment of the end inspiratory pressure and is used in conjunction with the inspiratory time control to control the inspiratory waveform and the delivered tidal volume. The calibration assists initial setting but the patient pressure manometer should always be used as the final reference of the pressure being achieved. There is a click-action on the control at pressure settings above 40 cmH2O in order to give a tactile warning that high levels are being selected. There is a corresponding red sector on the panel scale.

3.

Oxygen Concentration A unique gas mixing system enables the selection of precise oxygen concentration by means of the calibrated rotary control. There is a double calibration in order to be able to select the concentration with the two different gas supply possibilities. If oxygen alone is available as a compressed supply gas then a concentration range of 45% (approx.) - 100% oxygen concentration is possible. The air dilution is obtained by entraining atmospheric air. Because of this the minimum oxygen concentration setting (approximately 45% on the white scale), with oxygen only as a supply, is the most economic setting in terms of gas usage. If both oxygen and air are connected as gas sources then the yellow scale becomes operative and it is possible to select from 21 - 70% oxygen concentration. WARNING: An important safety feature of the babyPAC is that it continues to operate after the failure of one of the supply gases during two gas operation. However an inevitable change of delivered oxygen concentration occurs as indicated by the dual scale calibration. Hence, if the medical air supply fails the ventilator automatically changes to operate on the 50% - 100% oxygen concentration scale e.g. a 70% oxygen concentration from a dual supply rises to 100% with oxygen only. Therefore in the event of air supply failure the oxygen concentration should be reset if clinically necessary. * For Terms and Abbreviations used in this Manual see Section 8(d).

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If the oxygen supply ceases for any reason, the ventilator will only supply 21% oxygen to the patient, irrespective of the oxygen control setting. The control should always be left at the 21% setting in this mode of operation in order to achieve maximum gas economy. With any of the three gas supply options, when the oxygen concentration control is set to its minimum setting (i.e. 45% (approx.)/21% oxygen concentration), 2/3 of the gas delivered to the patient is entrained from the atmosphere. The usage of compressed gas is, therefore, at a minimum at this setting. Gas usage rises as the control is rotated to its maximum setting (100/70% oxygen concentration). NOTE: Although the babyPAC ventilator is extremely economical in its use of supply gas the actual gas usage will depend on the combination of settings selected. To assist the user, therefore, settings which result in high gas usage are marked on the control panel with red. These settings are, in general, also the settings which are best avoided if possible in situations where gas consumption is an important operational consideration. 4.

Function Selector Switch This five position rotary switch is used to select one of the four operating modes of the babyPAC ventilator and is also used to switch off the ventilator. In the CMV* + PEEP* position, the ventilator will cycle as set by the TINS and TEXP controls and at a pressure set by the inflation pressure control. The oxygen concentration and PEEP controls are operative in this mode. Flow is delivered to the patient circuit during the inspiratory period but is cut off during the expiratory period in order to economise on the utilisation of the compressed gas. PEEP pressure is maintained by the patient’s expiratory flow passing through the expiratory valve. NOTE: With this method of operation PEEP may not be achieved if, during testing, the ventilator is run with the patient connector occluded manually. PEEP will be achieved once a test lung, with both resistance and compliance, is attached. In the CPAP* position, the babyPAC ventilator delivers a constant flow of 10 L/min to the breathing system and excess gas is vented to atmosphere at the exhalation valve. The breathing system pressure is maintained at the constant pressure as set by the CPAP pressure control and is continuously displayed on the pressure manometer. In the CMV + ACTIVE PEEP* position, the ventilator operates as described under CMV + PEEP but the ventilator flow in the patient circuit is maintained throughout the expiratory period. This provides a PEEP that is less dependent on the lung characteristics of the patient, but the use of this mode will increase gas consumption by up to 80%. In the IMV* + CPAP* position, the expiratory time set on the scale is increased by a factor of 10. The CPAP function is present during the extended exhalation period. The inspiratory time and inflation pressure remain as under CMV and the CPAP pressure and oxygen concentration are as set by their controls.

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NOTE: The electronic alarm system is only operative when ‘CMV + PEEP’ or ‘CMV + ACTIVE PEEP’ is selected. 5.

PEEP/CPAP Control This calibrated rotary control has a dual function. When CMV modes are selected the control gives continuous adjustment of the pressure in the breathing system during the expiratory phase and hence sets the pressure achieved at the end of expiration. When CPAP or IMV+CPAP is selected then this control gives continuous adjustment of the constant positive pressure in the breathing circuit. As this setting will be slightly affected by the particular patient and ventilator settings this control is not calibrated so in both modes the patient manometer must be used as the reference for the set pressure. The PEEP/CPAP control has a click-action at pressure settings above 10 x100Pa (10 cmH2O) in order to give a tactile warning that high levels are being selected. There is a corresponding red sector on the panel scale

6.

Silencing and Muting 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 + PEEP’ or ‘CMV + ACTIVE PEEP’ selected) all alarms, except the single supply gas failure alarm, are automatically suspended although high priority visual alarms will still operate. Subsequently any audible alarm can be silenced for a 60 second period, by depressing the silencing button, but if a new alarm condition occurs during this period it will be automatically 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. If the alarm condition continues beyond the silenced period, a second depression of the button will be interpreted as an acknowledgment by the operator that the condition is continuous and so the audible alarm for that function is muted. Whilst any alarm is muted the 'silenced' visual indicator provides a burst of 8 flashes once every minute to serve as a reminder to the operator. The associated function visual indicator always continues to indicate the specific condition for which the alarm has been muted.

7.

Variable Relief Valve This calibrated rotary control gives continuous adjustment of an independent upper patient inflation pressure limitation device. A pneumatically operated audible alarm (25) is provided to signal that the limitation pressure has been achieved and that gas loss is occurring through this valve. This control should always be set above the set inspiratory pressure but below the pressure that is considered the safe maximum for the patient being ventilated

* See Section 8(e) & (f) for explanation of symbols & description of alarm priorities. 504-2056A

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The pneumatically operated alarm is backed up by a high priority* electronically generated audible and visual alarm. The electronic audible alarm only sounds after the 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 visual 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. 8.

Cycle Indicator During ventilation of the patient the inflation pressure is continuously monitored by a positive pressure detector pre-set to 10 x100Pa (10 cmH2O). 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.

9.

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 (10 cmH2O) at least once in any 8 second period. It should be noted that if a PEEP level greater than 10 x100Pa has been set then the cycling of the ventilator will not be detected but the constant positive inflation pressure alarm becomes activated. The audible component of this alarm will be silenced by depression of the silence button. A second depression of this button after the silence visual indicator has ceased is interpreted as an acknowledgement by the operator that this is an intended condition and so the alarm remains muted while the inflation pressure remains above 10 x100Pa. If a disconnection should occur the high PEEP level will not be maintained and the disconnect alarm will operate after 8 seconds. Both the audible and visual alarms reset when the alarm condition no longer exists.

10.

High Inflation Pressure / Constant Positive Inflation Pressure Alarm A high priority audible and visual 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 but below the set high alarm pressure for a period exceeding 8 seconds. Because this can also occur with the intended application of high levels of PEEP (above 10 x100Pa) the audible component of this alarm can be muted as described under 9 on Page 14. However, the visual component is maintained for the duration of this pressure’s presence to remind the operator that a high level of PEEP is still being used. See ‘WARNING’ in section 3, page 11, concerning oxygen concentration changes.

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11.

Supply Gas Failure Alarms Two mechanically operated visual alarms are provided to give warning if either of the supply gases is below the pressure required to operate the ventilator. With low pressure they show red, with adequate pressure they show white for the oxygen supply or black and white for the air supply respectively. The babyPAC ventilator will operate to specification on oxygen only (giving an output of 45% (approx.) - 100% oxygen concentration), air only (21% oxygen concentration output) or oxygen and air (21% - 70% oxygen concentration output). Any visible red on the alarm for a required gas indicates that the respective supply cylinder should be changed. Whenever the babyPAC ventilator is operating on one gas only the ‘single gas operation’ LED (26) indicator gives a burst of three flashes every 30 seconds. The visual indication of the failure of either one of two gas supplies is accompanied by an electronically generated medium priority* audible alarm. This alarm can be silenced for 60 seconds by depression of the silencing button. A second depression of this button after this 60 second period is interpreted as an acknowledgement by the operator that single gas operation is intentional and so the second gas failure alarm is then muted for the remainder of the ventilation or until a second gas supply is restored. Both the ‘single gas operation’ and the ‘muted’ indicators continue to flash appropriately whilst the muted condition persists. If the ventilator is switched on with only one gas supply pressurised this is taken as being an intended condition and no audible alarm is sounded for gas failure. With both the conditions described above the ‘single gas supply’ indicator will flash every 30 seconds to remind the operator that ‘single gas operation’ has been selected.

12.

The operator is alerted to the failure of a single gas supply by an electronically generated medium priority audible alarm, which sounds for 60 seconds. After this time the alarm system will switch itself off in order to protect the battery if the ventilator is left in a potential alarm condition after use. 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. Providing one of the visual indicators on the monitoring pod is flashing 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.

* See Section 8(e) & (f) for explanation of symbols and description of alarm priorities.

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13.

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 available 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 babyPAC 100 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. 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 babyPAC ventilator is switched off. Under general use conditions the specified batteries will give at least one year's service before requiring replacement. PRECAUTION: If the ventilator is unlikely to be used for a long time or is placed in storage, ensure that the function selector switch is left in the '0' (ventilator off) position. It is preferable also to remove the battery from its holder. WARNING: BATTERY FOR MRI USE: In order to avoid any risk of damage or injuryi)

14.

Use only battery supplied by Pneupac and marked “For use in MR compatible ventilators”. ii) Remove ventilator from MR environment before attempting to change battery. iii) Do not take a loose battery into an MR environment. Basic Operating Instructions This panel on the ventilator gives basic operating instructions to assist the infrequent user of the babyPAC ventilator. These instructions are not intended to replace, in any way, the more comprehensive instructions and information given in this Manual. A table is provided to assist the user in calculating ventilatory frequency from the settings of TI and TE.

15.

Alarm Information Label This label provides alarm battery information and a key to alarm signals.

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16.

Patient Pressure Manometer This pressure measuring device displays the patient pressure during both the inspiratory and the expiratory phase. This pressure is measured at the ventilator outlet to the patient circuit but when using the patient circuit provided the measured pressure is within 2 x100Pa (2 cmH2O) of the pressure at the patient connection under all modes of use.

17.

Gas Output Port This 22/15mm conical outlet connector is where the inspiratory limb of the patient circuit is connected. The patient inflation pressure is also monitored inside this port.

18.

Gas Return Port This 22/15mm conical connector is where the expiratory limb of the patient circuit is connected. It contains the exhalation valve that controls the breathing circuit pressure. Exhaled gas vents to atmosphere at this connector. The connector can be removed for cleaning by means of the knurled diameter, as described in section 5(b)(ii).

19.

Supply Gas Inlet Connection(s) Two connectors are provided for the supply of pressurised oxygen and air respectively. As standard, these are non interchangeable, proprietary, permanent connectors that require a spanner for disconnecting or connecting the supply hoses. User connectable gas specific connections in compliance with most major European, International and National Standards can be fitted as alternatives if specified at the time of ordering. For correct ventilator operation the gases supplied must be regulated and must be maintained within the pressure range of 305-600 kPa (3.05 to 6 bar) when supplying up to 20 L/min flow. The ventilator will operate with only one gas being supplied but, as explained previously, if only air is supplied the delivered oxygen concentration will be 21% irrespective of the setting of the concentration control.

20.

Gas Intake Port This port is used to take fresh air into the gas mixing system during certain modes of operation. It must, therefore, be kept free of obstruction at all times. It is fitted with a sintered metal filter to remove particulate matter from the entrained air.

21.

Patient Circuit The standard patient circuit consists of a symmetrical Y circuit with equal length and interchangeable inspiratory and expiratory limbs WARNING: Circuits of alternative materials may be used but if these circuits have higher compliance ventilatory performance may be compromised. Corrugated disposable hoses are not recommended for this reason. The patient connection port is a 15mm female conical connector.

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22.

Gas Supply Hoses The hoses supplied with the babyPAC ventilator are 2 meters long, 3mm bore and colour coded to BS 1319 and ISO 32. They are classed as “permanently connected” and are not to be used for any purpose other than supplying the babyPAC. The user connectable probes are gas specific and conform to BS 5682. A range of alternative oxygen and air gas supply hoses is available with connections, probes and colours in conformity to other Standards.

23.

Carry Sling Attachment 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 7mm deep female threaded bushes on the back of the control module may be used for the attachment of brackets or for direct mounting.

High Inflation Pressure Alarm 25.

Audible alarm The audible high pressure alarm is pneumatically powered by the gas relieved by the upper pressure limiting system and warns that the limiting pressure has been reached.

26.

Single Gas Operations A green visual indicator is provided to indicate that the unit is operating on one gas only (oxygen or air). The green LED illuminates 3 times every 30 seconds whenever the ventilator is operating on a single gas supply. If one of the gases fails the audible alarm will also sound until muted (section 2 (c) item11). (e)

Mounting Options

The babyPAC ventilator has been designed to be mounted and carried with a wide range of options, examples of which are shown in Fig. 2. It may be mounted with its base or back on a flat surface. Alternatively it can be carried on the shoulder by means of the carrying sling as shown in Fig. 2c.

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