Pneupac paraPAC plus Model 300 and 310 User Manual Oct 2019

Trademarks and acknowledgements: paraPAC plus, and the Pneupac and Smiths Medical design marks are trademarks of Smiths Medical. All other trademarks are acknowledged as the property 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 @ European Representative: Smiths Medical Czech Republic a.s. Olomoucká 306, Hranice 1 - Město, 75​​​3 01 Hranice, Czech Republic Tel: +44 (0) 1233 722100 www.smiths-medical.com

Co ntent s

Contents

Contents Section 1 - Safety Instructions...1 Summary Statement... 1 Warnings, Cautions and Precautions... 2 Warnings... 2 Warnings specific for the Patient Breathing Circuit... 6 Cautions... 6 General Precautions Relating to Battery Safety, Transportation and Disposal - See Appendix A... 7 Cautions specific for the Patient Breathing Circuit... 7

Section: 2 - General Information...9 Intended Use... 9 Variants Covered by this Manual... 10 Variant Features ... 10 General Description... 10 Contraindications ... 11 Controls and Features... 15 1. Frequency Control... 15 2. Tidal Volume Control (TDEL)... 15 3. Body Mass Symbols... 16 4. Function Switch & Manual Push-button... 16 5. Relief Pressure Control... 17 6. Air Mix Control... 17 7. Pressure Monitor... 18 8. Supply Gas Failure Alarm... 19 9. High Inflation Pressure Alarm... 19 10. Cycle Indicator... 20 11. Low Inflation Pressure (Disconnect) Alarm... 20 12. Breathing Detect Indicator... 21 13. Silencing and Muting of Electronic Audible Alarms... 21 14. Low Battery Alarm... 22 15. Basic Operating Instructions... 23 16. Alarm Information Label... 23 17. Battery Information Label... 23 18. Patient Outlet Connection... 23 19. PEEP Control (Model 310 only)... 24

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Contents

20. CPAP & Flow Control (Model 310 only) (TDEL)... 24 21. Patient Breathing Circuits... 25 21a. Standard Circuit... 26 21b. Standard Circuit with Mechanical PEEP valve. ... 27 22. O2 Input Connection... 27 23. Flow / CPAP Connection (Model 310 only)... 27 24. Pressure Monitoring Connection... 28 25. Mounting Attachment Points... 28 26. Input Hose... 28 Options Covered by this Manual... 29 Model Option... 29 Device Orientation and Installation Options... 29 Accessories... 30 Gas Cylinders... 30 Cylinder Regulators... 30

Section: 3 - Set-up, Functional Check and Use ...33 Set Up... 33 paraPAC plus™ ventilator... 33 Functional Check... 35 Pre use function test of the PEEP Function (Model 310 only)... 36 Pre use function test of the CPAP Function (Model 310 only)... 37 User’s Skill... 38 Setting of Ventilator... 38 Ventilating the Patient in I CMV...38 Use of CMV & Demand inhibit... 40 Demand breathing system... 40 Spontaneous breathing under power failure... 41 Manually Ventilating the patient in O DEMAND mode... 42 Use of CPAP (Model 310 only)... 44 O2 Therapy (Model 310 only)... 44 Ventilating Intubated Patients... 44 Positive End Expiration Pressure (PEEP)... 45 PEEP on Model 300 (Patient Circuit REF: 100/905/341)... 45 PEEP on Model 310 (Patient Circuit REF: 100/905/340)... 45 Use in Contaminated Atmospheres... 45 Use in a Magnetic Resonance Imaging (MRI) environment... 46 Use of Air Mix... 46 User Information Label... 48

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Co ntent s

Section: 4 - Care, Cleaning and Sterilisation...49 Contents

Care... 49 Cleaning , Disinfection and Sterilisation... 49 Ventilator... 49 Oxygen Input hose... 50 Care after device is subjected to dust... 50 Care after device is heavily wetted... 50 Care after device immersed in water... 51 Actions after contamination with vomitus... 51 Reassembly and Function Testing... 52

Section: 5 - Maintenance...53 General ... 53 Performance Checking... 53 Changing of Battery... 54 Servicing... 55

Section: 6 - Accessories and Spare Parts...57 Section: 7 - Technical Information...59 Essential Performance Criteria... 59 Principle of Operation... 59 Technical Data... 63 Principle of Operation: ... 63 Calibration of Tidal Volume Control ... 63 Colour Coding:... 64 Environmental Resistance... 68 Guidance and Manufacturer’s Declaration – Electromagnetic Emissions – for all ME Equipment and ME Systems... 70 Accuracies... 74 Terms and Definitions... 75 Explanation of Symbols and Alarm Condition Indicated... 77 Indicated Priority of Audible Alarm Sounds ... 79 MR Conditional Tests... 80 Test Information:... 80

Appendix A...83 Lithium Batteries - Product Safety and Disposal of Recommended Batteries... 83 Precations for Handling and Use... 83

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Contents

Precautions for Storage... 83 Charging... 84 Battery Disposal... 84

Appendix B...85 Calibration Accuracies and Deviations due to change in Ambient Conditions... 85 Calibration Accuracies & Deviations due to change in Ambient Conditions . 86 Effects of Inflation Pressure on Delivered Tidal Volume & Oxygen Concentration ... 87 Increase of delivered nominal FiO2 (≈50%) due to the entrainment of the paraPAC plus™ Model 310 PEEP control waste oxygen when ventilating a normal healthy adult lung of airway resistance R5 & lung compliance C50. ... 88

Appendix C...89 Delivered Oxygen concentrations when used for spontaneously breathing patients... 89

Appendix D...91 Cleaning and Inspection Record ... 91

List of Figures Figure 1: General views of the paraPAC plus™ 310... 12 Figure 2.1: Controls, Features & Interfaces of the paraPAC plus™ 310... 13 Figure 2.2: Controls, Features & Interfaces of the paraPAC plus™ 300... 14 Figure 3: paraPAC™ plus Model 310 Labels and their Locations... 31 Figure 4: paraPAC™ plus Model 300 Labels and their Locations... 32 Figure 5: paraPAC plus™ and Breathing Circuit... 33 Figure 6 paraPAC plus™ User Interfaces... 34 Figure 7: Selection for Manual Ventilation... 42 Figure 8: Manually Ventilating the patient in O DEMAND mode... 43 Figure 9.1: paraPAC plus™ Model 310 User Information Label ... 48 Figure 9.2: paraPAC plus™ Model 300 User Information Label... 48 Figure 10: Principles of operation of the paraPAC plus™ ventilator... 62 Figure 11: Charts illustrating the effects of Inflation Pressure on Delivered Tidal Volume & Oxygen Concentration... 87

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S ec t io n 1 - S afet y I nst r uc t io ns

Summary Statement The paraPAC plus™ ventilators are portable devices intended for the ventilation of adults, children and infants (above 10kg) during transportation and emergency situations. They consist of a control module and a remote patient valve, connected by means of a breathing hose. Both pneumatic and electronic alarms are incorporated. WARNING: Read this entire User Manual before operating the paraPAC Plus™ ventillator. Failure to properly follow warnings, cautions, and instructions could result in death or serious injury to the patient. Before use for the first time, all potential users must read the complete User Manual and 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 that are summarised on page 2. Failure to observe these warnings and precautions could compromise patient and/or user safety. Special guidance on the operation and use of the ventilator is given in Section 3 of this manual and basic operating instructions are provided on the label affixed to the control module. CAUTION: Federal (U.S.A.) law restricts this device to sale by or on the order of a physician. WARNING: To avoid harm to the patient, this equipment should only be used by personnel trained in the use of automatic ventilation. The equipment should only be used by medical personnel who have a full understanding of the techniques required for its use, or paramedical personnel who have received full and proper initial and ‘refresher’ instruction from a qualified person, both on resuscitation and on detailed use of the equipment in the situations in which it is likely to be employed. Information given in this manual beyond the basic operation of the ventilator is only intended as a guide to supplement proper medical training and to indicate the specific operational requirements of the paraPAC plus™ ventilator. WARNING: Failure to constantly monitor the patient whilst using this equipment may lead to death or serious injury. WARNING: To avoid harm to the patient, blood oxygenation and expired carbon dioxide levels should be monitored independently using pulse oximetry and capnography as part of due clinical diligence. Correct operation of the ventilator will not necessarily achieve the required blood gas levels. para PAC p lu s ™ U s e r Ma nua l - 1 0 0 1 1 6 9 6 - 0 0 3

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Safety Instructions

Section 1 - Safety Instructions

S ec tion 1 - S a fe t y I ns tru c ti o n s

Safety Instructions

The paraPAC plus™ 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, Cautions and Precautions Warnings Warnings are given to make you aware of dangerous conditions, that could lead to death or serious injury to the user or patient, that can occur if you do not obey all of the instructions given in this manual. 1.

2. 3. 4.

5.

6.

7.

2

WARNING: User’s handbook Read this entire User Manual before operating the paraPAC Plus™ ventillator. Failure to properly follow warnings, cautions, and instructions could result in death or serious injury to the patient. WARNING: personnel trained To avoid harm to the patient, this equipment should only be used by personnel trained in the use of automatic ventilation. WARNING: Constant monitoring of the patient. Failure to constantly monitor the patient whilst using this equipment may lead to death or serious injury. WARNING: blood gas levels To avoid harm to the patient, blood oxygenation and expired carbon dioxide levels should be monitored independently using pulse oximetry and capnography as part of due clinical diligence. Correct operation of the ventilator will not necessarily achieve the required blood gas levels. WARNING: Use of Oxygen To avoid the risk of ignition, do not smoke or have naked flames in the vicinity of oxygen. Do not allow oil, grease or combustible lubricants (only those approved for oxygen use) to come into contact with any part of the ventilator, regulator or cylinder. WARNING: Use in Aircraft To avoid the risk of explosion or interference, where used on aircraft, the use of this equipment must be authorised by the Aviation Authority and the Aircraft Operator. WARNING: Tidal Volumes Below 150mL Use of the ventilator and Patient Breathing Circuit at Tidal Volumes below 150ml may result in a CO2 build up and inadequate ventilation of the patient. For tidal volumes below 150ml the Smiths Medical Hyperinflation Bag system, in conjunction with the CPAP / Flow connector on the paraPAC plus™ Model 310 ventilator may be used. It cannot be used on the paraPAC plus™Model 300.

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8.

9.

10.

11.

12.

13.

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15.

WARNING: Use of CMV with Demand inhibit Facility Because the I CMV function has characteristics specific to this range of ventilators it is important that the sections of the operating instructions describing this facility (See "Variants Covered by this Manual" on page 10 and "Summary Statement" on page 1) are read before this version of the paraPAC plus™ ventilator is used so that the operator understands how the ventilator interacts with the patient during spontaneous breathing. WARNING: Direct Proximal Pressure Sensing Ventilators must never be used without the sensing line attached as this will result in a loss of ‘delivered volume’ to the patient. Although there is no net flow in the sensing line it is recommended that the microbio filter is always fitted to ensure that no patient contamination can enter the manometer circuit within the control module. WARNING: Battery for MRI Use To prevent possible risk of projectile injury within a MRI environment, routinely check for magnetic attraction. To avoid projectile risk in a MRI environment, use only the approved MRI conditional battery, Part No: W269-023. Do not attempt to remove the battery from the ventilator (or take a loose battery) in a MRI environment. WARNING: Potential Unsatisfactory Performance with Alternative Ventilator Patient Circuits. Ensure that only approved circuits supplied by Smiths Medical are used with the paraPAC plus™ range of ventilators. Failure to use the approved circuits could result in death or serious injury. To avoid cross contamination please be aware that the patient circuit is a single use device and should be disposed of after each use. WARNING: Provision of Accessories, Ancillaries and Spares for CE marked products The paraPAC plus™ 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. WARNING: Pre-Use Checks To avoid harm to the patient, pre-use checks must be performed before each use (See "Section: 3 - Set-up, Functional Check and Use" on page 33 and "Functional Check" on page 35) WARNING: Functional Check Deviations noted at functional check should be reported immediately to Smiths Medical and the unit must be taken out of service to avoid the risk of death or serious injury. WARNING: Release of Cylinder Pressure To avoid ignition by adiabatic compression, connect the ventilator to the regulator before opening the cylinder valve slowly. Similarly, prior to changing cylinders, turn off the cylinder valve, switching on the ventilator. When the ventilator stops, it is safe to release the pin index yoke.

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Safety Instructions

S ec t io n 1 - S afet y I nst r uc t io ns

S ec tion 1 - S a fe t y I ns tru c ti o n s

Safety Instructions

16. WARNING: Provision of Alternative Means of Ventilation Always ensure that an alternative means of ventilation is available in the event of ventilator failure or malfunction. 17. WARNING: Adequacy of Gas Supply To avoid harm to the patient, 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. 18. WARNING: Interpreting of ‘Spontaneous Breath’ Indicator Actuation of the ‘Spontaneous Breath’ indicator only indicates that spontaneous breathing has been detected and that the low-pressure alarm has been reset as a consequence. The operator must still ensure that patient minute ventilation is adequate. 19. WARNING: Heat Moisture Exchanger (HME) filter 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 occuring, filters and HME’s should be routinely replaced in accordance with the manufacturer’s instructions. 20. WARNING: Use in Extreme Environments Extreme environments may impair ventilator performance (see Appendix B), operator vigilance is required to monitor the patient. 21. WARNING: Patient Transportation To avoid harm to the patient, inter- or intra-hospital transport should only be undertaken according to established medical practice and under medical supervision. 22. WARNING: Projectile Risk To reduce the risks of potential projectile injury to the user or patient, the normal routine of checking the ventilator system for magnetic attraction should be followed whenever the equipment is taken into an MRI environment to ensure that magnetically attracted parts have not been added to the system inadvertently. 23. WARNING: Use in Contaminated Atmosphere The paraPAC plus™ ventilator models are suitable for use in contaminated and toxic atmospheres subject to certain limitations as described below and these should be clearly understood by those likely to use the equipment in such environments so that it is only used where appropriate. In any situations where the respirable qualities of the immediate environment are suspect, ventilation should only be carried out in the 100% oxygen (no air mix) mode. This ensures that only a minimum of ambient gas can enter the breathing system. 24. WARNING: MRI Use To prevent possible risk of projectile injury within a MRI environment, routinely check for magnetic attraction. When in use in a MRI environment, to prevent injury to the patient, check the

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26. 27. 28.

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pressure manometer to confirm unchanged ventilation. Also, test the highpressure relief/alarm system by temporary circuit disconnection and occlusion of the ventilator outlet connector, both whenever the system is taken into a MRI environment, and every time the patient is positioned within the magnetic field. WARNING: Training Requirements All operators who are not medically qualified should receive full and proper instruction from a qualified person, both on resuscitation and on detailed use of the equipment in the particular situations in which it might be employed. WARNING: Regular functional checks for devices in storage To avoid harm to the patient, if the device remains unused for a period exceeding three months, conduct a functional check. WARNING: Approved Accessories Failure to use approved circuits and accessories may lead to unsatisfactory ventilator performance. WARNING: Lithium batteries Lithium batteries are of the primary type and are NOT designed to be recharged. Attempts to recharge these batteries can lead to leakage and possibly an explosion. WARNING: Use in very confined spaces Do not use this ventilator in very confined spaces, as oxygen concentration will be affected, due to expired gas from the expiration valve entering the fresh gas intake port. Where fitting in a confined space is necessary, consult Smiths Medical for installation advice. WARNING: Storage in Low Temperatures After storing at temperatures below -18°C set controls to 40 bpm and tidal volume 150mL and connect to gas at higher than 0°C before CMV operation and reset controls as desired once ventilator is cycling. WARNING: Adjacent or Stacked Usage This equipment should not be used adjacent to or stacked with other equipment and if adjacent or stacked use is necessary, the equipment should be observed to verify normal operation in the configuration in which it will be used. WARNING: During operation in high temperature environments, the device may have a maximum surface temperature of 50 °C. Use caution when in use.

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S ec t io n 1 - S afet y I nst r uc t io ns

S ec tion 1 - S a fe t y I ns tru c ti o n s

Warnings specific for the Patient Breathing Circuit

Safety Instructions

Note: The warnings specific for the Patient Breathing Circuit are listed here for information only. Refer to Instructions for Use part number 100/905/340 and 100/905/341 for the latest information. A. B. C. D. E. F.

Users must ensure that they are knowledgeable and proficient in the use of the ventilator and circuit before use to allow them to be used safely. Ensure that the circuit is undamaged, complete, assembled correctly and fully functional before use. Failure to do so could lead to inadequate ventilation. Ensure that all connections are secure. Failure to do so could lead to inadequate ventilation. Ensure that the inline filter is securely attached to the ventilator and that the pressure monitoring line is not kinked. Failure to do so could lead to incorrect or misleading readings on the ventilator’s manometer. Pressure test the circuit before use to verify leak resistance. Failure to do so could lead to inadequate ventilation. Ensure that the PEEP valve is set to the minimum pressure before connecting the circuit to the patient. Failure to do so could lead to patient injury.

Cautions Cautions warn of dangerous conditions that can occur and cause damage to the ventilator or its accessories, if you do not obey all of the instructions given in this manual. 1. 2. 3. 4. 5.

6.

6

CAUTION: Federal (U.S.A.) law restricts this device to sale by or on the order of a physician. 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. CAUTION: When storing for long periods, to avoid the risk of possible corrosion or drain of the battery, ensure that the ventilator is left in the ‘Demand’ (Off) (ventilator off) position and the battery is removed from its holder. CAUTION: To ensure that the cylinder contents are not lost during storage due to small leakages, it is recommended that the valve on the gas cylinder is turned off after use. CAUTION: Do not attempt to sterilise the paraPAC plus™ 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 the paraPAC plus™. CAUTION: If the device is accidentally immersed in water or any liquid, it should no longer be operated and an alternative means of ventilation used (see Warning #16).

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S ec t io n 1 - S afet y I nst r uc t io ns

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

CAUTION: To avoid risk of of internal corrosion within the device, use only dry, filtered gas. Safety Instructions

1.

Cautions specific for the Patient Breathing Circuit Note: The cautions specific for the Patient Breathing Circuit are listed here for information only. Refer to Instructions for Use part number 100/905/340 and 100/905/341 for the latest information. a.

Non-clinical testing has demonstrated the mechanical PEEP Valve in circuit REF: 100/905/341 is MR Conditional. There is no projectile risk. It can be scanned safely under the following conditions: • static magnetic field of 3 Tesla or less • spatial gradient field of 750 Gauss/cm (7.5 T/m) or less • Normal operating mode or first level controlled operating mode

b.

If the PEEP Valve is placed at a distance less than 30cm from the area of interest it will affect image quality. Optimization of MR imaging parameters to compensate for the presence of this device may be necessary. If circuit 100/905/341 is used with Model 310 and the circuits PEEP valve is set higher than the value set by the ventilator’s separate PEEP control, the value indicated on the mechanical PEEP valve will be the calibration to follow. At all times, use the ventilator’s manometer to accurately monitor the set PEEP.

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S ec tion 1 - S a fe t y I ns tru c ti o n s

Safety Instructions Page Intentionally Blank

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S e c t i o n 2 - G eneral I nfo r m at io n

Section: 2 - General Information WARNING: To avoid the risk of ignition, do not smoke or have naked flames in the vicinity of oxygen. Do not allow oil, grease or combustible lubricants (only those approved for oxygen use) to come into contact with any part of the ventilator, regulator or cylinder. The paraPAC plus™ range are gas-powered emergency and transport portable ventilators that are primarily intended for use in transport applications in vehicles including fixed and rotary wing aircraft. They are suitable for emergency use at the accident scene, intra and inter-hospital transport and within medical facilities including magnetic imaging systems to 3 Tesla. They should only be used under the constant supervision of trained healthcare professionals. The devices are intended to provide ventilatory support for adults, children and infants (above approx. 10 kg). The devices also provide free flow oxygen therapy and CPAP therapy for spontaneously breathing patients. The paraPAC plus™ can also be used in emergency situations to provide ventilatory support for CPR resuscitation using the manual ventilation control button. The paraPAC plus™ ventilators and associated equipment described in this manual conform to International Standards for Emergency and Transport Ventilators and comply with the requirements of the European Directive for Medical Devices 93/42/EEC. WARNING: To avoid the risk of explosion or interference, where used on aircraft, the use of this equipment must be authorised by the Aviation Authority and the Aircraft Operator. Non-clinical testing has demonstrated the paraPAC plus™ is MR conditional. There is no projectile risk. It can be scanned safely under the following conditions: • static magnetic field of 3 Tesla or less • spatial gradient field of 750 Gauss/cm (7.5 T/m) or less • testing was conducted in the I CMV and II modes. Demand was also tested as part of the I

operating CMV mode.

If the ventilator is placed at a distance less than 30cm from the area of interest it will affect image quality and could affect the ventilator’s electronic alarms.

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General Information

Intended Use

S ec tion 2 - G e ne ra l I n fo r m ati o n

Variants Covered by this Manual This manual addresses both the paraPAC plus™ variants – Model 310 and 300. Features that are not applicable to the Model 300 are annotated (Model 310 Only), as Model 310 is enhanced variant of the Model 300. The majority of the illustrations in this User Manual are of the Model 310.

Variant Features General Information

Feature

Model 300

Model 310

8 to 40 bpm Frequency Control

✔

✔

70 to 1500 ml Tidal volume control

✔

✔

Air mix control 100% or 50% oxygen concentration

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Manual breath button

✔

✔

Demand oxygen therapy function

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✔

Demand inhibit of CMV

✔

✔

Electronic alarm

✔

✔

PEEP Control on ventilator

✔

II FLOW control

✔

General Description The paraPAC plus™ ventilator consists of a control module and a remote patient valve, connected by means of a corrugated hose (See Fig 1). A description of controls and features on the paraPAC plus™ ventilator is given, see Controls and Features on page 15, the number reference against each description corresponds to the number shown in Figures 2.1 and 2.2. The paraPAC plus™ ventilator is a gas powered (use only dry filtered gas), time cycled ventilator which depends solely on the pressure of the supply gas for its operation. The models described in this Manual additionally incorporate an integrated electronic pressure alarm unit to alert the user to certain significant changes that 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 paraPAC plus™ ventilator, nor affect the mechanically operated alarms and protection systems.

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CAUTION: To avoid risk of internal corrosion within the device, use only dry, filtered gas. The control module of the paraPAC plus™ ventilator is rugged by virtue of the design of case, internal pneumatics and electronics. The controls are recessed to minimise the possibilities of damage. Calibrated frequency and tidal volume controls are provided to set the required ventilation pattern and these are clearly colour coded to indicate the recommended settings for adults, children and infants. Used in conjunction with the patient pressure manometer, the PEEP control (Model 310 only) is provided to set PEEP between 0 and 20 cm H2O. An air mix control gives a FiO2 option of 0.50 or 1.0. For longer term ventilation the 0.50 FiO2 setting will normally be used and in this setting gas consumption is significantly reduced - by almost 70% - giving greatly extended cylinder duration. On the paraPAC plus™ ventilator, selection can be made between O DEMAND, I CMV & II (Model 310 only). When I CMV is selected, the ventilator cycles at the set frequency but if a spontaneous breath is taken during an exhalation phase then this is taken from an internal demand valve. If breathing is at an adequate level for an adult, cycling will be inhibited as long as this breathing level is maintained. If breathing becomes inadequate, CMV will be restored, synchronised with the last breath. When O DEMAND, is selected, only the internal demand valve is energised by the gas supply. When the patient is connected to the patient valve, any spontaneous breathing effort is satisfied by flow from the demand valve. This provides a very gas efficient method of treating a victim with an unprotected airway where enhanced oxygen [tidal volume dependent see table in Appendix C, page 45] is recommended as the approved therapy. It can also be used to protect a spontaneously breathing patient during rescue from a contaminated atmosphere. The control module is designed to be mounted in a variety of ways as described on page 29. A wide range of attachments and brackets are also available. The paraPAC plus™ ventilator may be driven by oxygen from a compressed gas cylinder or pipeline system.

Contraindications None known

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General Information

S e c t i o n 2 - G eneral I nfo r m at io n

S ec tion 2 - G e ne ra l I n fo r m ati o n

General Information WARNING ONLY USE MR Conditional batteries. Do not remove the battery in an MRI environment.

Lithium 3/3.6V only AA - Pneupac Part #W269-023 ISO10651-3 (EN60601-1) Type B internally powered.

High Pressure Low Press./Disconnect Low Gas Supply Low Voltage Supply Cycle Indicator Spontaneous Breath Alarm Silenced

High Priority Medium Priority Medium Priority Medium Priority

Visual Alarms Information

Figure 1: General views of the paraPAC plus™ 310

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S e c t i o n 2 - G eneral I nfo r m at io n

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General Information

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Figure 2.1: Controls, Features & Interfaces of the paraPAC plus™ 310

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S ec tion 2 - G e ne ra l I n fo r m ati o n

5

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General Information

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14 12 13

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21 22

24

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Figure 2.2: Controls, Features & Interfaces of the paraPAC plus™ 300

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