Pneupac babyPAC 100 User Manual March 2019

Trademarks and acknowledgements: babyPAC and the Pneupac design mark and Smiths Medical design mark are trademarks of Smiths Medical. The symbol ® indicates the trademark is registered in the U.S. Patent and Trademark Office and certain other countries. All other names and marks mentioned are the trade names, trademarks or service marks of their respective owners. Published by Smiths Medical Limited. All possible care has been taken in the preparation of this publication, but Smiths Medical accepts no liability for any inaccuracies that may be found. Smiths Medical reserves the right to make changes without notice both to this publication and to the product which it describes. No part of this publication may be reproduced, transmitted, transcribed, or stored in a retrieval system or translated into any human or computer language in any form or by any means without the prior permission of Smiths Medical. © 2019 Smiths Medical. All rights reserved.

H Manufacturer: Smiths Medical ASD, Inc. 6000 Nathan Lane North Minneapolis, MN 55442 USA Tel: 1 800 258 5361 (US/CA) Tel: +1 614 210 7300 www.smiths-medical.com

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Contents

Contents Section: 1 - Summary Statement...5 Warnings and Cautions ... 6 Warnings... 6 Cautions... 11

Section: 2 - General Information...13 Intended Use... 13 Contraindications – none known... 13 General Description... 14 Controls and Features ... 16 1. Controls for Inspiratory and Expiratory Times... 17 2. Inspiratory Pressure... 17 3. Oxygen Concentration... 17 4. Function Selector Switch... 18 5. PEEP/CPAP Control... 19 6. Silencing and Muting of Electronic Audible Alarms... 20 7. Variable Relief Valve... 20 8. Cycle Indicator... 21 9. Low Inflation Pressure (Disconnect) Alarm... 21 10. High Inflation Pressure / Constant Positive Inflation Pressure Alarm... 21 11. Supply Gas Failure Alarms ... 22 12. Low Battery Alarm... 23 13. Battery ... 23 14. Basic Operating Instructions... 24 15. Alarm Information Label... 24 16. Patient Pressure Manometer... 24 17. Gas Output Port... 24 18. Gas Return Port... 24 19. Supply Gas Inlet Connection(s)... 25 20. Gas Intake Port... 25 21. Patient Circuit... 25 22. Gas Supply Hoses... 26 23. Carry Sling Attachment Slots... 26 24. Mounting Attachment Points ... 26 25. High Inspiratory Pressure Audible alarm... 26 26. Single Gas Operations... 26 b a byPAC™ 100 U ser Manual - 1 0 0 0 2 0 5 3 -0 0 4

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Mounting Options... 27 Accessories... 29

Section: 3 - Set-up and Functional Check ...31 Set-up... 31 Functional Check... 31 Mechanical Shock... 34 General... 34 Gas Failure Visual Indicator Check... 34

Section: 4 - Operation ...35 User’s Skill... 35 Setting of Ventilator... 35 General... 35 Ventilating Patient ... 35 Humidification... 37 Manual Ventilation... 38 Gas Usage... 38 Use with MRI (MR Conditional)... 39

Section: 5 - Care, Cleaning & Sterilisation ...41 Care... 41 Cleaning... 41 Control Module:... 41 Hoses... 42 Disinfection... 42 Sterilisation... 42 Reassembly and Function Testing... 42 Exhalation valve removal & re-assembly procedure... 43 Replacement of Diaphragm... 43 babyPAC™ 100 Status... 43 Procedure... 43 Functional Check... 45

Section: 6 - Maintenance...47 General ... 47 Performance Checking... 47 Changing of battery... 47 Servicing... 48

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Section: 7 - Accessories and Spare Parts ...49 Section: 8 - Technical Information...51 Principles Of Operation... 51 Technical Data... 54 Principle of operation... 54 Accuracies ... 57 Terms and Definitions... 57 Explanation of Symbols ... 59 Indicated Priority of Audible Alarm Sounds ... 62 MR Conditional Tests... 63 Test information:... 63

Appendix A ...67 Product Safety, Transportation and Disposal of Lithium Batteries... 67 Precautions for Handling and use... 67 Precautions for Storage... 67 Charging... 68 Transportation... 68 Criteria for Exemption of Lithium Batteries from Transportation Regulations... 68 References... 69 Disposal... 69 Disposal Procedures... 69

Appendix B...71 Calibration accuracies and deviations due to change in ambient conditions ... 71

Appendix C...73 Cleaning and inspection... 73

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S ec t i o n 1 - S a fet y I n s t r u c t i o n s

WARNING: User’s handbook Read this entire User Manual before operating the babyPAC™ Ventilator. Failure to properly follow warnings, cautions, and instructions could result in death or serious injury to the patient. WARNING: This device is only intended for use in a transport and emergency environment. It IS NOT intended for use as a critical care device. The babyPAC™ 100 is a portable gas powered transport ventilator, suitable for use in an MRI environment up to 3 Tesla, which features a battery powered integrated electronic pressure alarm unit. It is designed for use by qualified medical caregivers, paramedics and other trained personnel, for ambulance, hospital, emergency, and transport ventilation of patients during respiratory distress or insufficiency. It IS NOT intended for use as a critical care device. It can be used on neonates and infants up to a bodyweight of 44lb (20 kg). The babyPAC™ 100 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. CAUTION: Federal Law (USA) restricts the use or sale of this device by, or on the order of, a physician. 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 cautions which are summarised (see page 6). Failure to observe these warnings and cautions 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™ 100 ventilator.

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Safety Instructions

Section: 1 - Summary Statement

S e c t i o n 1 - Sa fe t y I nst ruc tions

Safety Instructions

The babyPAC™ 100 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.

Warnings and Cautions The following Warnings and Cautions highlight aspects of the use of the babyPAC™ 100 ventilator that require particular emphasis. The section of this manual referenced in each clause provides the relevant context.

Warnings 1. 2.

3.

4.

5.

6

WARNING: Critical Care Use To avoid harm to the patient, this device is not intended for critical care use. WARNING: user’s handbook Read this entire User Manual before operating the babyPAC™ Ventilator. Failure to properly follow warnings, cautions, and instructions could result in death or serious injury to the patient. WARNING: Operator skill and training (see page 5) 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™ 100 ventilator. WARNING: Use of Oxygen (see page 32) 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. WARNING: Avoid smoking or naked flame.

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6.

7.

8.

9.

10.

11.

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13.

WARNING: Use in Aircraft (see page 13) 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. WARNING: Battery for MRI Use (see page 24) In order to avoid any possible projectile risk causing damage or injuryi) Use only the Smiths Medical approved MR Conditional battery, Part number: W269-023. ii) Remove ventilator from MR environment before attempting to change battery. iii) Do not take a loose battery into an MR environment. WARNING: Potential Unsatisfactory Performance with Alternative Ventilator Patient Circuits (see page 25) 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. WARNING: Provision of Accessories, Ancillaries and Spares for CE marked products (see pages 29, 48 & 49). The babyPAC™ 100 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 and accessories. Failure to use approved circuits and accessories may lead to unsatisfactory ventilator performance. WARNING: Pre-Use Checks (see page 35) To avoid harm to the patient, pre-use checks must be performed before each use. WARNING: Functional Check (see page 45) 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 completed. WARNING: Release of Cylinder Pressure (see page 33) 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. WARNING: Provision of Alternative Means of Ventilation (see page 35) 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 (e.g. a manual ventilator) is readily available to use should ventilator failure occur.

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Safety Instructions

S ec t i o n 1 - S a fet y I n s t r u c t i o n s

S e c t i o n 1 - Sa fe t y I nst ruc tions

Safety Instructions

14. WARNING: Adequacy of Gas Supply (see page 35) 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. 15. WARNING: Care When Using Ventilator for Manual Ventilation (see page 38) The operator must maintain constant observation of the patient pressure manometer during manual ventilation using the ventilator to ensure that overinflation is avoided. 16. WARNING: MRI Use (see page 39) The normal routine of checking the ventilator system for magnetic attraction should be followed whenever the equipment is taken into an MR environment to ensure that magnetic parts have not been added to the system inadvertently. 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. 17. WARNING: Use in Extreme Environments (see page 71) 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. 18. WARNING: Damaged Patient Circuit Connectors (see page 31) To avoid harm to the patient, user’s should be aware that it is important to check the patient circuit connectors for damage, as damaged connectors could adversely effect ventilator performance. 19. WARNING: Legionella in some hospital hot water reservoirs (see page 41) Since some hospital hot water reservoirs may harbour Legionella, to avoid harm to the patient, cleaning should be followed by disinfection OR sterilization. Failing this, however, the cleaning operation should be carried out using sterile water. 20. WARNING: Oxygen Concentration (see page 18) An important safety feature of the babyPAC™ 100 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

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Safety Instructions

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. Control set to minimum setting (fully anti-clockwise), approximately 45% concentration. Control set to maximum setting (fully clockwise) 100% concentration. Note: Oxygen concentrations – The user should be aware that the oxygen concentration could be as low as 93%, when the ventilator is set at a high ventilation frequency and the 100% O2 position. 21. WARNING: Low Inspiratory Pressure (see page 25) To avoid the risk of low inspiratory pressure, PEEP and CPAP, when using the disposable patient circuit (REF: 2010007), the user should check that the monitoring luer lock port is correctly plugged. 22. WARNING: Shock (see page 14) To avoid the risk of harm to the patient, if the ventilator module is subjected to excessive shock (i.e., dropped) whilst in use, the user must carry out functional checks specified on page 31 of this manual before re use. (See also Warning #12 : ‘Functional check’) 23. WARNING: Single Use Breathing Circuit (see page 25) To avoid the risk of cross contamination, the Disposable Patient Circuit and Exhalation Valve Diaphragm (REF: 122004), must be discarded in a responsible manner. The user should not clean, disinfect or sterilise the circuit or the Exhalation Valve Diaphragm for reuse’ 24. WARNING: Low Gas Indicator In Extreme Operating Temperatures (see page 22) Although the normal switching pressures for the gas indicator eyeball are nominally 33psi with rising pressure and 40 psi with falling pressure, the user should be aware that there may be an increase of 2 to 3 psi on these values when the ventilator is being used at the temperature extremes of operation. 25. WARNING: Scanner Image Quality (see page 65) Use of any other type of battery than that specified may affect scanner image quality.

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S e c t i o n 1 - Sa fe t y I nst ruc tions

Safety Instructions

26. WARNING: Heat Moisture Exchanger (HME) filter (see page 37) If a Heat Moisture Exchanger (HME) filter is used and the patient is experiencing breathing difficulties, or there are mechanical ventilation problems, or decreases in gas exchange, always ensure that there are no blockages in the breathing system. If a blockage is found, immediately replace the breathing system or HME filter. To prevent such problems occurring, filters and HME’s should be routinely replaced in accordance with the manufacturer’s instructions. 27. WARNING: Exhalation Valve Diaphragm Fitment (see page 44) To avoid the risk of the exhalation valve diaphragm remaining depressed against the valve housing and resulting in continuous pressure loss from the patient circuit, avoid depressing the centre of the diaphragm during fitment. Following the replacement procedure, ensure that the centre of the diaphragm is not depressed and always perform a functional check. 28. WARNING: When fitting a replacement exhalation valve diaphragm, the user should be aware that passive PEEP and Peak Pressure performance may change. It is therefore important that, prior to use, performance of the PEEP and Peak Pressure functions should be tested using the pre-use checks in this manual. If the performance is found to be outside the quoted range, contact Smiths Medical. 29. WARNING: At all times check adequacy of gas supply by observing the gas failure alarm and the gas cylinder contents indicator. 30. WARNING: Any deviations observed in the functional check 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 completed.

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Cautions CAUTION: Federal Law (USA) Federal Law (USA) restricts the use or sale of this device by, or on the order of a physician. 2. CAUTION: Protection of Battery and Ventilator during periods without use (see page 24) 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. 3. CAUTION: Prevention of Gas Loss (see page 33). 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. 4. CAUTION: Battery Safety, Transportation and Disposal Precautions, (see page 67). 5. CAUTION: Use In Confined Spaces (see page 28). If the babyPAC™ 100 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. 6. CAUTION: Do not attempt to sterilise the babyPAC™ 100 or to clean it by immersion in any fluid. Do not use any cream cleanser. Do not allow any petrochemical or its derivative (petrol, diesel, paraffin etc.) come into contact with the device. Do not autoclave (see page 41). 7. CAUTION: 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 (see page 41). 8. CAUTION: Drop in PEEP Level (see page 25). When using the disposable patient hose part number 2010007, the user should be aware that if the hose is pulled or stretched when in use, the PEEP level can drop momentarily. 9. CAUTION: Silicone Parts (see page 44). DO NOT use solvents to clean any of the silicone components, this may result in silicone becoming adhesive and consequently creating an obstruction in the airway path. 10. CAUTION: R.F. Interference (see page 35). With high levels of Electromagnetic R.F. Interference (350MHz to 450MHz) applied, it is possible the Batttery Low LED may momentarily flash in time with peak levels in excess of 13 V/m field strength. A momentary flash does not indicate battery failure (see page 23) #12 for battery failure indications). 11. CAUTION: Ensure that the valve seat rim is not damaged. A damaged valve seat rim will result in a loss in passive PEEP performance. (PEEP achieved in CMV + PEEP mode) (see page 44). b a byPAC™ 100 U ser Manual - 1 0 0 0 2 0 5 3 -0 0 4

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Safety Instructions

1.

S e c t i o n 1 - Sa fe t y I nst ruc tions

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S ec t i o n 2 - G en era l I n fo r m at i o n

Section: 2 - General Information WARNING: This device is only intended for use in a transport and emergency environment. It IS NOT intended for use as a critical care device. The babyPAC™ 100 is a portable gas powered transport ventilator, suitable for use in an MRI environment up to 3 Tesla’s, which features a battery powered integrated electronic pressure alarm unit. It is designed for use by qualified medical caregivers, paramedics and other trained personnel, for hospital, emergency, and transport ventilation of patients during respiratory distress or insufficiency. It IS NOT intended for use as a critical care device. It can be used on neonates and infants up to a bodyweight of 44lb (20 kg). These ventilators are extremely economical (See Technical data’“Duration of Gas Supply:” on page 55) 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™ 100 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.

Contraindications – none known.

*

See “Terms and Definitions” on page 57.

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General Information

Intended Use

S e c t i o n 2 - G enera l I nfor mation

General Description

General Information

The babyPAC™ 100 ventilator consists of a control module with a conventional Y patient circuit (see ”Figure 1a” on page 16). 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 signalled to the user but will have no effect on the ventilation performance of the babyPAC™ 100 ventilator, nor affect the mechanically operated alarms and protection systems. The control module of the babyPAC™ 100 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. WARNING: To avoid the risk of harm to the patient, if the ventilator module is subjected to excessive shock (i.e., dropped) whilst in use, the user must carry out functional checks specified on page 31 of this manual before re use. (See also Warning #12 : ‘Functional check’). 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. 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 * See “Terms and Definitions” on page 57.

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S ec t i o n 2 - G en era l I n fo r m at i o n

so that this can be extended up to 40 seconds – allowing time for spontaneous breathing between the mandatory ventilations.

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 twist-to-remove housing and a silicone rubber valve element (see page 42 for further information). babyPAC™ 100 ventilators have been supplied which are suitable for ventilating patients whilst being subjected to MRI procedures. (see page 39 & 63 for further details concerning MR Compatibility). The control module is designed to be mounted in a variety of ways as described, see “Mounting Options” on page 27. A sling is available to enable the unit to be carried from the user’s shoulder, contact Smiths Medical Customers Services or your local Sales Representative for availability.

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General Information

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.

S e c t i o n 2 - G enera l I nfor mation

Controls and Features 22

19

25

20

10

7

8

9

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1a

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1b

General Information

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26

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Figure 1a

23 15 24 13

Figure 1b 16

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S ec t i o n 2 - G en era l I n fo r m at i o n

1.

Controls for Inspiratory and Expiratory Times

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 ) e.g. 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.

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General Information

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.

S e c t i o n 2 - G enera l I nfor mation

General Information

WARNING: An important safety feature of the babyPAC™ 100 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. It is recommended that an oxygen monitor is used in conjunction with babyPAC™ 100 to obtain more accurate readings of the oxygen concentrations. 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: Oxygen concentrations – The user should be aware that the oxygen concentration could be as low as 93%, when the ventilator is set at a high ventilation frequency and the 100% O2 position. Note: Although the babyPAC™ 100 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™ 100 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 * See “Terms and Definitions” on page 57.

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