Pneupac paraPAC 200 & 200D Users Manual Issue 11 May 2009

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paraPAC 200 & 200D Ventilator User's Manual (including Model Options /MRI and /EP) Table of Contents SECTION 1: SUMMARY AND SAFETY INSTRUCTIONS ... 7 (a) Summary Statement ... 7 (b) Warnings, Cautions and Precautions ... 8 (i) WARNINGS ... 8 (ii) CAUTIONS ... 14

SECTION 2: GENERAL INFORMATION ... 15 (a) Intended Use ... 15 (b) General Description ... 15 (c) Contraindications – none known... 17 (d) Controls and Features (Figures 1a and 1b) ... 17 (e) Options Covered by this Manual ... 27 (i) Model Option ... 27 (ii) Mounting Options ... 27 (f) Accessories ... 29 (i) Instant Action Case ... 29 (ii) Gas Cylinders ... 29 (iii) Cylinder Regulators ... 29 (iv) Oxygen Therapy Unit... 29 (v) Aspirator... 30 (vi) PEEP Valves ... 30 (vii) Clausen Harness and Hook Ring... 31

SECTION 3: SET-UP AND FUNCTIONAL CHECK... 33 (a) Set Up ... 33 (i) paraPAC ventilator... 33 (ii) Instant Action Set... 33 (b) Functional Check ... 36

SECTION 4: OPERATION... 39 (a) User's Skill ... 39 (b) Setting of Ventilator... 39 (i) General ... 39 (ii) Ventilating Patient... 39 (c) Use of Air Mix ... 41 (d) Use of CMV/Demand ... 42 (e) Ventilating Intubated Patients... 43 (f) Positive End Expiration Pressure (PEEP) ... 43 504-1116A 3

(g) Use in Contaminated Atmospheres... 44 (h) Use with MRI (MR Compatibility)... 45 (i) User Information Label (Figure 5)... 46 SECTION 5: CARE, CLEANING, DISINFECTION & STERILISATION... 47 (a) Care... 47 (b) Cleaning ... 47 (i) Control Module ... 47 (ii) Patient valve ... 47 (iii) Hoses... 48 (c) Disinfection... 48 (d) Sterilisation ... 48 (e) Reassembly and Function Testing ... 48 SECTION 6: MAINTENANCE ... 49 (a) General... 49 (b) Performance Checking... 49 (c) Changing of Battery... 49 (d) Servicing ... 50 SECTION 7: ACCESSORIES AND SPARE PARTS ... 51 SECTION 8: TECHNICAL INFORMATION ... 53 (a) Principle of Operation... 53 (b) Technical Data ... 58 (c) Accuracies... 61 (d) Terms and Definitions... 62 (e) Explanation of Symbols and Alarm Condition Indicated ... 64 (f) Indicated Priority of Audible Alarm Sounds ... 66 (g) MR Compatibility Tests... 67 (i) Equipment ... 67 (ii) Projectile Risk: ... 67 (iii) Ventilator performance tests: ... 67 (iv) Imaging Tests:... 68 (v) Effect of switching gradients... 68 (vi) Effect of RF fields... 68 (vii) Image quality... 68 Appendix A: Lithium Batteries – Product Safety Transportation and Disposal... 71 Appendix B: Calibration accuracies & deviations due to change in ambient conditions... 77 Appendix C: PEEP Valve Usage in MRI Environments... 81 504-1116A

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Mask end assembly ... 81 PEEP valve end assembly ... 82 Appendix D: EP Option Assembly Instructions ... 87 Appendix E: Delivered Oxygen concentrations when using the ventilator in the ‘Off’ (‘Demand’) mode for spontaneously breathing patients... 91 Appendix F: Cleaning and inspection record log check... 95

List of Figures Figure 1a: Front view of paraPAC ventilator ... 19 Figure 1b: Rear and side view of paraPAC ventilator ... 20 Figure 2a, 2b& 2c: Model Options ... 28 Figure 2d & 2e: Model Options ... 28 Figure 3: Connection of the patient valve / PEEP valve/ Exhaust collector accessories... 31 Figure 4: Instant Action Carrying Case ... 35 Figure 5: paraPAC 200D User information Label... 46 Figure 6a: Principles of operation of the non demand version of the paraPAC ventilator ... 53 Figure 6b: Principles of operation of the demand version of the paraPAC ventilator ... 55 Figure 6c: Cross-section of schematic patient circuit ... 57

Smiths Medical International Ltd. reserves the right to make changes, without notice, which may affect the information contained in this manual. Additional copies of this User’s Manual can be obtained from Smiths Medical International Ltd. "Pneupac", "paraPAC ", "paraPAC 200, "paraPAC 200D" and “Smiths” are trademarks of the Smiths medical family of companies. The symbol R indicates that it is registered in the U.S. Patent and Trademark Office and certain other countries. Patent pending.

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SECTION 1: SUMMARY AND SAFETY INSTRUCTIONS (a) Summary Statement The paraPAC 200 & 200D ventilators are portable devices intended for the ventilation of adults, children and infants (above 5kg) during transportation and emergency situations. They consist of a control module and a remote patient valve, connected by means of a breathing hose. Both pneumatic and electronic alarms are incorporated. WARNING: Failure to read this user’s handbook before first use of this device may result in death or serious injury Before use for the first time, all potential users must read the complete User’s Manual 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 in section 1(b). Failure to observe these warnings and precautions could compromise patient and/or user safety. Special guidance on the operation and use of the ventilator is given in section 4 of this manual and basic operating instructions are provided on the label affixed to the control module. WARNING: Federal law (USA) restricts the use or sale of this device by, or on the order of, a physician WARNING: To avoid harm to the patient, this equipment should only be used by personnel trained in the use of automatic ventilation. (SECTION 1(a)). The equipment should only be used by medical personnel who have a full understanding of the techniques required for its use, or paramedical personnel who have received full and proper initial and 'refresher' instruction from a qualified person, both on resuscitation and on detailed use of the equipment in the situations in which it is likely to be employed. Information given in this manual beyond the basic operation of the ventilator is only intended as a guide to supplement proper medical training and to indicate the specific operational requirements of the paraPAC 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 gas levels must be monitored independently, correct operation of the ventilator will not necessarily achieve the required blood gas levels. 504-1116A

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

WARNING: user’s handbook

Failure to read this user’s handbook before first use of this device may result in death or serious injury (SECTION 1(a)). 2.

WARNING: Federal law (USA) Restrictions

Federal law (USA) restricts the use or sale of this device by, or on the order of, a physician (Sect. 1(a)). 3.

WARNING: personnel trained

To avoid harm to the patient, this equipment should only be used by personnel trained in the use of automatic ventilation. (SECTION 1(a)). 4.

WARNING: Constant monitoring of the patient

Failure to constantly monitor the patient whilst using this equipment may lead to death or serious injury. (SECTIONS 1(a) & 4(d)). 5.

WARNING: blood gas levels

To avoid harm to the patient, blood gas levels must be monitored independently, correct operation of the ventilator will not necessarily achieve the required blood gas levels. (SECTION 1(a)).

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6.

WARNING: Use of Oxygen (Section 3(a) and 3(b)13)

Avoid smoking or naked flame. To avoid the risk of ignition, do not use oil, grease or combustible lubricants (only those approved for oxygen use) in contact with any part of the ventilator, regulator or cylinder. To avoid ignition by adiabatic compression, connect the ventilator to the regulator before opening the cylinder valve slowly. Similarly, prior to changing cylinders, turn off the cylinder valve, switching on the ventilator. When the ventilator stops, it is safe to release the pin index yoke. 7.

WARNING: Use in Aircraft (Section 2(a))

To avoid the risk of explosion or interference, where used on aircraft, the use of this equipment must be authorised by the Aviation Authority and the Aircraft Operator. 8.

WARNING: Use of CMV/Demand Facility (Section 2(b) and 4(d))

Because this function has characteristics specific to this range of ventilators it is important that the sections of the operating instructions describing this facility (Sections 2(b) and 4(d)) are read before this version of the paraPAC ventilator is used so that the operator understands how the ventilator interacts with the patient during spontaneous breathing. 9.

WARNING: Direct Patient Inflation Pressure Sensing - EP Option (1) (Section 2(d)6 and 2(e) i))

Although there is no net flow in the sensing line it is recommended that a microbial filter is always inserted in the sensing line to ensure that no patient contamination can enter the manometer circuit within the control module. 10. WARNING: Direct Patient Inflation Pressure Sensing - EP Option (2) (Section 2(d)6 and 2(e) i)) Ventilators with the /EP option must never be used without the sensing line attached as this will result in a loss of ‘delivered volume’ to the patient. DO NOT use Star Lumen section tubing (see warning 32).

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11. WARNING: Battery for MRI Use (Section 2(d)15) To avoid projectile risk in a MRI environment, use only the approved MRI compatible battery, Part No: W269-023. Do not attempt to remove the battery from the ventilator (or take a loose battery) in a MRI environment. (Section 2(d) # 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. 12. WARNING: Potential Unsatisfactory Performance with Alternative Ventilator Patient Circuits (Section 2(d)18 and 6(d)) Failure to use approved circuits and accessories may lead to unsatisfactory ventilator performance. 13. WARNING: Special Patient Valve (Section 2(d)20) The patient valve is specially modified to match it to the performance of the paraPAC ventilator and only valves supplied with the units, or bearing the specified part number, should be used. Any other valve may compromise the ventilation performance of the paraPAC ventilator. 14. WARNING: Provision of Accessories, Ancillaries and Spares for CE marked products. Section 2(f), 6(d) & 7) The paraPAC 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. 15. WARNING: Use of Clausen Harness (Section 2(f) (vii)) Because the operator is no longer supporting the head and chin, particular care must be taken that the victim’s airway is maintained open during these procedures and constant checks should be made for gas availability and correct ventilator function. 16. WARNING: Functional Check (Section 3(b)13) 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. 504-1116A

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17. WARNING: Pre-Use Checks To avoid harm to the patient, pre-use checks must be performed (See Section 3(a) and 3(b) Points #1 to #8 inclusive) before each use. 18. WARNING: Release of Cylinder Pressure (Section 3(b)13) To avoid ignition by adiabatic compression, connect the ventilator to the regulator before opening the cylinder valve slowly. Similarly, prior to changing cylinders, turn off the cylinder valve, switching on the ventilator. When the ventilator stops, it is safe to release the pin index yoke. 19. WARNING: Provision of Alternative Means of Ventilation (Sect. 4) Always ensure that an alternative means of ventilation is available in the event of ventilator failure or malfunction. 20. WARNING: Adequacy of Gas Supply (Section 4(b)(ii)) 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. 21. WARNING: Interpretation of ‘Breathing Detect’ Indicator (Sect. 4(d)) Actuation of the ‘breathing detect’ indicator only indicates that spontaneous breathing has been detected and that the low-pressure alarm has been reset as a consequence. The operator must still ensure that patient minute ventilation is adequate. 22. WARNING: Use in Contaminated Atmosphere (1) (Section 4(g)) The paraPAC 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. 23. WARNING: Use in Contaminated Atmosphere (2) (Section 4(g)) In any situations where the respirable qualities of the immediate environment are suspect, ventilation should only be carried out in the ‘No Air Mix’ mode. This ensures that only a minimum of ambient gas can enter the breathing system. 504-1116A

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24. WARNING: MRI Use (Section 4(h)) To prevent possible risk of projectile injury within a MRI environment, routinely check for magnetic attraction. When in use in a MRI environment, to prevent injury to the patient, check the pressure manometer to confirm unchanged ventilation. Also, test the high-pressure relief/alarm 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. 25. WARNING: Training Requirements (Section 4(i)) All operators who are not medically qualified should receive full and proper instruction from a qualified person, both on resuscitation and on detailed use of the equipment in the particular situations in which it might be employed (see Section 1(a)) 26. WARNING: Use in Extreme Environments (Sect. 4 and Appdx. B) Extreme environments may impair ventilator performance (see Appendix B), operator vigilance is required to monitor the patient. 27. 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. (Appendix A). 28. 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. (Section 2(e) ii)). 29. WARNING: Pressure Gauge - non EP Units Where the non EP version of P200D is being used, to avoid the risk of harm to the patient, the user should be aware that any malfunction in the Demand valve or patient tubing, including dangerous or fatal malfunctions, cannot be reliably detected by observing the pressure gauge (Sects. 2(b), 2(d) #20, 2(e) (i) and 2(e) (vi)). 504-1116A

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30. WARNING: PEEP Valve and Pressure Where a PEEP Valve is being used, to avoid risk of harm to the patient, the User should be aware that PEEP and any malfunction in the PEEP Valve, Breathing Circuit or Exhalation Port cannot be reliably detected by observing the Pressure Manometer (Sect. 2f) vii)). 31. 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. 32. WARNING: Star Lumen Cross-section tubing (Sect. 7 & Appdx. D) To avoid inaccurate indications on the manometer, DO NOT use star lumen cross section tubing for the sensing line. 33. WARNING: Dead Space Within Patient Circuits To avoid harm to the patient as a result of excessive dead space, only use recommended patient breathing circuits which have been tested to meet the tolerances stated in the standards (See Section 2(d) Point #18).

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(ii)

CAUTIONS

Cautions warn of dangerous conditions that can occur and cause damage to the ventilator or its accessories, if you do not obey all of the instructions given in this manual. 1. CAUTION: When storing for long periods, to avoid the risk of possible corrosion 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 (Sect. 2(d) # 15). 2. 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. (Sect. 2(d)15). 3. General Precautions Relating to Battery Safety, Transportation and Disposal. See Appendix A. 4. CAUTION : To avoid damage to the EP circuit, detach all EP Circuit parts from the Patient Hose prior to autoclaving. DO NOT autoclave EP Accessories. 5. CAUTION : To avoid risk of of internal corrosion within the device, use only dry, filtered gas (Sect. 2(b) & 4(b) ii).

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SECTION 2: GENERAL INFORMATION (a)

Intended Use

The paraPAC 200 & 200D ventilators are portable ventilators specifically designed for use by paramedic and other qualified persons, for adult, child and infant (above approx. 5 kg) ventilation during cardiopulmonary (CPR), as well as for rescue breathing, in accordance with the 1986 'JAMA'* standards. The paraPAC 200 & 200D ventilators have been type tested and have been assessed to be MR compatible in accordance with FDA Good Guidance Practice: ‘A primer on medical devices interactions with Magnetic Resonance Imaging System’:1997, when placed in a magnetic field of 3 Tesla and a field gradient of 430G/cm. Full details of the tests are given in Section 8(g)’. The 200D model is especially suitable for the treatment of victims with a protected airway in rescues from toxic or non respirable atmospheres as it offers the choice of oxygen upon demand (tidal volume dependent see table in Appendix E) or ventilatory back up to the patient whilst normal breathing is being restored This CMV*/Demand feature may also be used for weaning patients back to normal breathing from controlled ventilation. The paraPAC ventilators and associated equipment described in this manual conform to European Standard EN 794-3 "Particular Requirements for Emergency and Transport Ventilators" and comply with the requirements of the European Directive for Medical Devices 93/42/EEC. WARNING: To avoid the risk of explosion or interference, where used on aircraft, the use of this equipment must be authorised by the Aviation Authority and the Aircraft Operator. (b) General Description WARNING: Use of CMV/Demand Facility: Because this function has characteristics specific to this range of ventilators it is important that the sections of the operating instructions describing this facility (Sections 2(b) and 4(d)) are read before this version of the paraPAC ventilator is used so that the operator understands how the ventilator interacts with the patient during spontaneous breathing. * See Terms and Definitions, Section 8 (d). 504-1116A 15

The paraPAC ventilator consists of a control module and a remote patient valve, connected by means of a spirally reinforced hose (See Fig 1a). A description of controls and features on the paraPAC ventilator is given in Section 2(a), the number reference against each description corresponds to the number reference shown in Figure 1a. The paraPAC 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 ventilator, nor affect the mechanically operated alarms and protection systems. CAUTION : To avoid risk of of internal corrosion within the device, use only dry, filtered gas. The control module of the paraPAC ventilator is rugged by virtue of its thick section structural foam plastic case and the use of anti-shock mountings for the gauge, internal pneumatics and electronics. The controls are recessed to minimise the possibilities of damage. Calibrated 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. An air mix control gives a FiO2 option of 0.45 or 1.0. For longer term ventilation the 0.45 FiO2 setting will normally be used and in this setting gas consumption is significantly reduced - by almost 70% - giving greatly extended cylinder duration or allowing the use of a much smaller compressor if compressed air is used as the driving gas. WARNING: Where the non EP version of P200D is being used, to avoid the risk of harm to the patient, the user should be aware that any malfunction in the non-rebreathing valve or patient tubing, including dangerous or fatal malfunctions, cannot be reliably detected by observing the pressure gauge.

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On the paraPAC 200D ventilator, selection can be made between ‘Demand’ (Off) and ‘CMV/Demand’ (On). When ‘CMV/Demand’ (On) 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 Off (‘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 a protected airway where enhanced oxygen [tidal volume dependent see table in Appendix E] is recommended as the approved therapy can also be used to protect a spontaneously breathing patient during rescue from a contaminated atmosphere. The control module is designed to be mounted in a variety of ways as described under Section 2 (e) (ii) 'Mounting Options'. A sling is available to enable the unit to be carried from the user's shoulder. It may also be carried, together with a compressed gas cylinder, within a Pneupac 'Instant Action' carrying case. A wide range of attachments and brackets is also available. The paraPAC ventilator may be driven by oxygen or air from a compressed gas cylinder, pipeline system, or one of the airPAC portable compressors. (c) Contraindications – none known (d) Controls and Features (Figures 1a and 1b) 1. Frequency Control This calibrated rotary control knob gives simultaneous continuous adjustment of the frequency of ventilation over the range 8 to 40 breaths per minute. It does this by varying both inspiration and expiration time in such a way that the inspiration time is limited to within the range 1.0 to 1.5 seconds when the frequency is between 12 and 20 breaths per minute so as to give the correct ventilation patterns for CPR* and rescue breathing in accordance with the American Heart Association's (JAMA*) 'Standards and Guidelines for Cardiopulmonary Resuscitation' (1986). There is a detent and a heart symbol at 12 b/min to aid selection of the recommended setting for adult (CPR). The frequency range on the paraPAC ventilator extends beyond that required by the AHA* guidelines in order to give flexibility of use in a wide range of situations. *See Terms and Definitions, Section 8(d)

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At 8 breaths per minute the I:E ratio becomes 1:3 and at 40 breaths per minute it is 1:1.3. The extended exhalation period at the adult settings provides the correct time for 5 interposed chest compressions between each breath, as required during CPR. 2. Tidal Volume Control This rotary control knob gives continuous adjustment of the flow to the patient over the range 6-60 litres per minute. For ease of use in the emergency situation, it is calibrated in terms of tidal volume (VT=TI x Flow). Variations of inspiratory time with frequency setting mean that this calibration can only be an approximation but in practice, because the two adjustments will normally be made in unison, and because the variations of inspiratory time are limited, the resultant accuracy is sufficient for the intended application of the ventilator. Colour coding is used on both this and the frequency control to give guidance as to the combination of settings, which should normally be used, and these correspond to values in the AHA guidelines. For further details refer to Technical Data, Section 8(b). 3.

Main Pneumatic Switch (a) Model 200 ventilator only - This knob operates a rotary two position switch to start or stop the when it is connected to a suitable gas supply. (b) Model 200D ventilator only - This knob operates a rotary switch to select ‘Demand’ (Off) only or the 'CMV*/Demand' facility which provides controlled mandatory ventilation to non breathing patients but which allows inhibition if an adult patient commences spontaneous breathing to an adequate level. WARNING: Because this function has characteristics specific to this range of ventilators it is important that the sections of the operating instructions describing this facility (Sections 2(b) and 4 (d)) are read before this version of the paraPAC ventilator is used so that the operator understands how the ventilator interacts with the patient during spontaneous breathing. Selection of 'CMV*/Demand' also switches on the electronic alarm but for the first 60 seconds of the ventilator operation most of the alarm functions are automatically suspended in order to allow time to apply the ventilator to the patient. Selection of ‘Demand’ (Off) or '0' switches off the alarm unit. *See Terms and Definitions, Section 8(d)

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Figure 1a: 504-1116A

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Front view of paraPAC ventilator 19

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Optional EP Sensing Line shown here for illustrative purposes. Refer to Appendix C for detailed information

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Figure 1b:

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Rear and side view of paraPAC ventilator

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