Smiths Medical Pneupac babyPAC 100 User Manual
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Smiths Medical Pneupac babyPAC 100 User Manual

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Pneupac
USER'S MANUAL
0473
Smiths medical family of companies ©2006
PN 504-2056A
Issue 6 10/2006
504-2056A
®
babyPAC 100
Ventilator
1
Smiths Medical International Ltd
Bramingham Business Park
Enterprise Way
Luton LU3 4BU
England
Tel: (44) (0) 1582 430000
Fax: (44) (0) 1582 430001
Email:
info@smiths-medical.com
Website:
www.smiths-medical.com

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  • Page 1 Smiths Medical International Ltd Bramingham Business Park Enterprise Way Luton LU3 4BU England Tel: (44) (0) 1582 430000 Fax: (44) (0) 1582 430001 0473 Smiths medical family of companies ©2006 Email: info@smiths-medical.com PN 504-2056A Website: www.smiths-medical.com Issue 6 10/2006 504-2056A...

  • Page 2: Table Of Contents

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  • Page 3: Table Of Contents

    babyPAC 100 Ventilator User's Manual Table Of Contents Page Number Table Of Contents ........................2 SECTION 1 SUMMARY STATEMENT................5 Warnings and Precautions ....................5 SECTION 2 GENERAL INFORMATION ................11 Intended Use ........................11 Contraindications – none known..................11 General Description......................11 Controls and Features (See Figs. 1a & 1b)..............13 Mounting Options......................20 Accessories ........................21 SECTION 3 : SET-UP AND FUNCTIONAL CHECK .............23...
  • Page 4 Calibration accuracies and deviations due to change in ambient conditions .59 Appendix C - Cleaning and inspection log ................63 Smiths Medical International Ltd. reserves the right to make changes, without notice, which may affect the information contained in this manual.

  • Page 5: Section 1 Summary Statement

    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.
  • Page 6 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. 3. Warning: Avoid smoking or naked flame. 4.
  • Page 7 11. Warning: 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 (e.g. a manual ventilator) is readily available to use should ventilator failure occur. 12.
  • Page 8 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.
  • Page 9 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 that the cylinder contents are not lost during storage due to small leakages. 3. Battery Safety, Transportation and Disposal Precautions, See Appendix A. 4.
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  • Page 11: Section 2 General Information

    SECTION 2 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’...
  • Page 12 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.

  • Page 13: (B) Controls And Features (See Figs. 1A & 1B)

    Controls and Features (See Figs. 1a & 1b) Figure 1a Figure 1b 504-2056A...
  • Page 14 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.
  • Page 15 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% position. 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.
  • Page 16 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.
  • Page 17 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.
  • Page 18 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.
  • Page 19 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 T and T Alarm Information Label...

  • Page 20: (E) Mounting Options

    The patient connection port is a 15mm female conical connector. 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.

  • Page 21: (F) Accessories

    Figure 2a and Figure 2b Figure 2c PRECAUTION: 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.
  • Page 22 Figure 3 Gas Cylinders ® 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. (iii) Cylinder Regulators ®...

  • Page 23: Section 3 : Set-Up And Functional Check

    SECTION 3 : SET-UP AND FUNCTIONAL CHECK Set Up Unpack the babyPAC ventilator 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. To avoid harm to the patient, user’s should be aware that it is important to check WARNING: the patient circuit connectors for damage, as damaged connectors could adversely...
  • Page 24 NOTE: The gas source(s) must be capable of maintaining a pressure of at least 305 kPa (≈3 bar) whilst delivering a flow of 20 L/min. If connected to a cylinder regulator(s) turn on cylinder valve(s) slowly. Check that the visual alarm(s) for supply gas failure have changed from red to white (oxygen) or black and white (air).
  • Page 25 Finally, set the controls as specified in step 1 so that the ventilator is left set for emergency use. Any deviations observed in the above checking should be reported immediately to WARNING: 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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  • Page 27: Section 4 Operation

    SECTION 4 OPERATION In accordance with recognised industry practice for all ventilators ensure that, WARNING: 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.

  • Page 28: (C) Humidification

    Temporarily disconnect the ventilator circuit at the connection closest to the patient and verify that the green cycle 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 adverse ventilation conditions can be detected and corrected before the patient is put at risk.

  • Page 29: (D) Manual Ventilation

    If a heated water humidifier is used the user must provide a suitable circuit (heated if necessary) and it must be remembered that the pressure monitor indicates the VBS pressure at the ventilator. When the recommended circuits are used then the inspiratory pressure is accurately displayed, but if circuit components are introduced that have measurable flow resistance then the consequent pressure drop will give a corresponding error in the displayed pressure.
  • Page 30 is not generally recommended because the increased compliance will affect the volume which can be delivered by the ventilator for larger patients and the maximum effective frequency for smaller babies. It is also more susceptible to kinking and inadvertent flattening.) All parts which contain metals and which are MR Compatible are marked "/MRI"...

  • Page 31: Section 5 Care, Cleaning & Sterilisation

    SECTION 5 CARE, CLEANING & STERILISATION Care The babyPAC 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.

  • Page 32: (C) Disinfection

    Disinfection After cleaning, the exhalation valve components and the patient circuit may be disinfected by immersion in a cold solution of disinfectant or germicide. Always follow the manufacturers instructions. Rinse and carefully dry all components before reassembly. The control module may be wiped with a disinfectant but it must not be immersed. Sterilisation The components of the exhalation valve and the patient circuit may be steam sterilised up to 134°C.

  • Page 33: Babypac Status

    babyPAC Status Ensure that: it is safe to switch off the babyPAC. Procedure Removal Disconnect the return hose that is connected to the Exhalation Valve Housing (3). Gently unscrew the Exhalation Valve Housing (3). iii) Remove the Exhalation Valve Diaphragm (2) off the spigot (4) carefully to avoid damage, ie. tears and distortion.
  • Page 34 vii) Position and secure the Exhalation Valve Housing to the fixed part of the Exhalation Valve, ensuring you do not overtighten the Exhalation Valve Housing (finger tight is adequate). The unit is now ready for a functional check. Functional Check 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...

  • Page 35: Section 6 Maintenance

    SECTION 6 MAINTENANCE General Because of the high reliability and long life of the control elements used, the babyPAC ventilator 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.

  • Page 36: (D) Servicing

    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 elctronically alarmed ventilation is interrupted.

  • Page 37: Section 7 Accessories And Spare Parts

    SECTION 7 ACCESSORIES AND SPARE PARTS (Only parts with an Order Code incorporating /CE may be sold to countries bound by the European Medical Devices Directive for use with CE marked babyPAC ventilators bearing a CE mark (see Section 1(b)) Description Order Code Patient Circuit,...
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  • Page 39: Section 8 Technical Information

    SECTION 8 TECHNICAL INFORMATION Principles Of Operation The principle of operation of the babyPAC ventilator is illustrated by the block diagram in Fig 4, page 42. Compressed oxygen and/or air enter the ventilator from the input hoses at the inlet connectors 1 and 2.
  • Page 40 by a factor of 10. CPAP operates during this extended expiratory phase in order to supply the required concentration of oxygen to the spontaneously breathing patient. The multifunction alarm built into the babyPAC ventilators is electrically powered by a replaceable single cell lithium battery but the ventilatory functions of the babyPAC ventilators are completely independent of the alarm functions and its power source.
  • Page 41 Figure 4 504-2056A...
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  • Page 43: (B) Technical Data

    Technical Data Principle of operation The babyPAC ventilator functions as a time cycled pressure generator in the CMV mode and uses an entrainment type mixer to provide variable oxygen concentration. Power Source: Gas specific terminal outlet(s) providing dry, oil free, filtered gas within the pressure range 305 to 600 kPa at 20 L/min.
  • Page 44 PEEP (Passive): 0-20 x100Pa (0-20 cmH O) with click-action warning at and above 10 x100Pa (10 cmH PEEP(Active) / CPAP: (2/3)-20 x100Pa ((2/3)-20 cmH O) with click-action warning at and above 10 x100Pa (10 cmH IMV: Expiratory time 2.5 to 40 sec with CPAP Pressure level and oxygen concentration as selected.

  • Page 45: (C) Accuracies

    Patents: This product is covered by the following patents; UK 2,174,760B EP 0343818 US 5605148 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’...

  • Page 46: (D) Terms And Definitions

    Terms and Definitions Pressure drop across airway per unit flow. Airway Resistance: CPAP: Constant Positive Airway Pressure. The ventilator maintains a set constant positive pressure in the breathing circuit throughout the ventilation cycle when the patient is breathing spontaneously. CMV: Controlled Mandatory Ventilation.

  • Page 47: (E) Explanation Of Symbols

    Explanation of Symbols Description Symbol Gas Output The babyPAC ventilator breathing system, supplied with the ventilator, is attached to this connector to transfer ventilating gas from the ventilator to the patient connector. Gas Return Port Connector Second limb of the breathing system is attached to this connector to transfer the patient’s expiratory gases to the expiratory valve.
  • Page 48 In accordance with Directive 2002/96/EC Waste Electrical and electronic Equipment, Smiths Medical International Ltd. requires that residents of the European Union return this product for proper disposal at the end of its useful life. Contact your local distributor for specific instructions on how to return the product for disposal.

  • Page 49: (F) Indicated Priority Of Audible Alarm Sounds

    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.
  • Page 50 the field and trial disconnections and high airway pressures were always correctly indicated. 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.
  • Page 51 APPENDIX A Product Safety, Transportation and Disposal of Recommended Batteries 504-2056A...
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  • Page 53: Appendix A - Product Safety, Transportation And Disposal Of Lithium Batteries

    Appendix A - Product Safety, Transportation and Disposal of Lithium Batteries 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.
  • Page 54 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.
  • Page 55 • European Agreement Concerning the International Carriage of Dangerous Goods by Road (ADR). 1993 Edition. London: HMSO, 1992. • Regulations Concerning the International Carriage of Dangerous Goods by Rail (RID). 1990 Edition. London: HMSO, 1989. • International Maritime Dangerous Goods Code. London: International Maritime organisation, 1992.
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  • Page 57: Appendix B Calibration Accuracies And Deviations Due To Change In Ambient Conditions

    APPENDIX B Calibration accuracies and deviations due to change in ambient conditions 504-2056A...
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  • Page 59 Appendix B Calibration accuracies and deviations due to change in ambient conditions Table 2: Calibration accuracies and deviations due to change in ambient conditions Deviations due to change in ambient conditions Accuracies of calibrated controls Parameter Ambient Ambient Ambient Ambient Factory calibrated to Further deviation temperature...
  • Page 60 Table 3: Inspiration & Expiration accuracies Setting factory calibrated in field service (seconds) (seconds) 4.0 E time ± 0.60 ± 0.80 2.0 I & E time ± 0.30 ± 0.40 1.0 I & E time ± 0.15 ± 0.20 0.75 I & E time ±...
  • Page 61 APPENDIX C Cleaning and inspection 504-2056A...
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  • Page 63: Appendix C - Cleaning And Inspection Log

    Appendix C - Cleaning and inspection log Contents Cleanliness Functional Cylinder Date Signature Comments Complete Checked Performance contents Check (section 3 (b) 504-2056A...
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