Pneupac paraPAC 200 & 200D Users Manual Issue 7 May 2009

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User's Manual For paraPAC 20 & 20D (including Model Options /MRI and /EP) Table of Contents SECTION 1: SUMMARY STATEMENT...7 (a) WARNINGS: -Warnings and Precautions ...9 (b) Cautions:- ...15 SECTION 2 GENERAL INFORMATION ...17 (a) Intended Use...17 (b) General Description ...18 (c) Contraindications ...19 (d) Controls and Features (Figure 1)...19 (e) Options (Covered by this Manual) ...26 (f) Accessories...29 SECTION 3: SET-UP AND FUNCTIONAL CHECK...32 (a) Set Up...32 (b) Functional Check ...35

SECTION 4: OPERATION...37 (a) User's Skill ...37 (b) Setting of Ventilator...38 (c) Air Mix...39 (d) Use of CMV/Demand (Model 20D only) ...40 (e) Ventilating Intubated Patients ...42 (f) Positive End Expiration Pressure (PEEP) ...42 (g) Use in Contaminated Atmospheres ...43 (h) User Information Label (Figure 5) ...44 SECTION 5: CARE, CLEANING & STERILIZATION ...47 (a) Care ...47 (b) Cleaning ...47 (c) Disinfection ...48 (d) Sterilization ...48 SECTION 6: MAINTENANCE ...51 (a) General ...51 (b) Performance Checking ...51 504-1116/CE 3

(c) Service...51 SECTION 7: ACCESSORIES AND SPARE PARTS ...53 SECTION 8: CLEANING AND INSPECTION LOG ...57 SECTION 9: TECHNICAL INFORMATION ...59 (a) Principle of Operation ...59 (b) Technical Data ...63 (c) Accuracies ...67 (d) Terms and Definitions...68 (e) Explanation of Symbols and Alarm Condition Indicated ...70 Appendix A: Deviations due to changes in ambient conditions...73 Appendix B: PEEP Valve Usage in MRI Environments...77 Mask end assembly...77 PEEP valve end assembly ...78 Appendix C: EP Option Assembly Instructions ...83 Figure C.1: Schematic diagram of the EP Option assembly...84 Appendix D: Delivered Oxygen concentrations when using the ventilator in the ‘Off’ (‘Demand’) mode for spontaneously breathing patients...87 List Of Figures Figure 1a: Controls and Features Location - Front...23 Figure 1b: Controls and Features Location - Rear...24 Figure 2a & 2b: Surface Mount

Figure 2c: Sling Attachment ...28

Figure 2d : Rail Fixture

Figure 2e: Pole Fixture...28

Figure 3: PEEP Valve...31 Figure 4: Instant Action Set...33 Figure 5a: paraPAC 2D - User Information Label ...44 Figure 5b: paraPAC 2 - User Information Label ...45 Figure 5a: Block Schematic Diagram – Non-Demand ...61 Figure 5b: Block Schematic Diagram – Demand ...62 Figure 5c: Cross-section of schematic patient circuit ...63 Figure B.1: Schematic diagram of the required assembly ...77 504-1116/CE

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Figure B.2: Assembly of Mask end components of the PEEP valve...78 Figure B.3: Assembly of PEEP valve end components...78 Figure B.4: Complete Assembly...79 Smiths Medical reserves the right to make changes, without notice, which may affect the information contained in this manual. Trademarks: The names "Pneupac", “paraPAC” and "Smiths" are registered trademarks of Smiths medical family of companies..

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SECTION 1: SUMMARY STATEMENT The paraPAC 20 & 20D 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*. They are also suitable for ventilation during patient transport. WARNING: Failure to read this User’s Manual before first use of this device may result in death or serious injury WARNING: To avoid harm to the patient, pre-use checks must be performed in accordance with section 4 of this manual before each use. WARNING: Always ensure that an alternative means of ventilation is available in the event of ventilator failure or malfunction. Before use for the first time, all potential users must read the complete User’s Manual, they should also familiarise themselves with the unit and its operation to enable them to use it effectively. They should study the contents of this Manual to the extent required to supplement their training. Special attention must be paid to warnings and precautions which are summarised in section 1(a), (b) and (c). Failure to observe these warnings, cautions 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: To avoid harm to the patient, this equipment should only be used by personnel trained in the use of automatic ventilation. 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: Failure to constantly monitor the patient whilst using this equipment may lead to death or serious injury. 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 *

See Terms and Definitions, Section 10(d)

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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: Blood gas levels must be monitored independently, correct operation of the ventilator will not necessarily achieve the required blood gas levels. Also, when used at moderate altitude, it is essential that the user closely monitors delivered tidal volume, and measures end-tidal CO2 using suitable capnography. The paraPAC ventilator is intended only for use in transport and emergency situations where the patient is being constantly monitored by the carer. The ventilator cannot give an accurate indication 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. WARNING: To avoid the risk of ignition, do not use oil, grease or combustible lubricants (only those approved for oxygen use) to come into contact with any part of the ventilator, regulator or cylinder. Avoid smoking or naked flame. WARNING: 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. Although use of this ventilator outside the environmental conditions specified in this Manual will not directly lead to a safety hazard but the performance will become increasingly uncertain as the conditions become more extreme. Therefore the operator must exercise constant patient vigilance under these conditions. The European mandated standards specifying particular requirements for ventilators (EN 794) state that users must be advised that whenever a patient is being ventilated by means of an automatic ventilator the user should ensure that an alternative means of ventilation (eg a manual ventilator) is readily available.

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WARNING: To avoid the risk of harm to the patient from an incorrectly set ventilator, servicing or adjustment of this equipment should only be carried out by competent personnel who have been trained by Smiths Medical to carry out such work. Servicing or adjustment of this equipment should only be carried out by competent personnel who have been trained for such work. The paraPAC ventilators described in this manual carry a CE mark to certify that they have been manufactured to conform to the requirements of the European Medical Devices Directive 93/42/EEC. To ensure that this equipment is maintained to the requirements of the Directive, only accessories, ancillaries and spares authorised by the manufacturer should be fitted. All such parts sold by Smiths Medical have /CE incorporated in their Order Code. Parts that are not marked with /CE are only for sale outside the countries bound by the Directive. CAUTION: Although this ventilator has been fully tested to withstand water spray from all directions, it is not designed to be immersed in water. In the event the the module is accidentally immersed, it should no longer be operated and an alternative means of ventilation used (see also warning #3) The ventilator should then be returned to the manufacturer for rectification. (a) WARNINGS: -Warnings and Precautions 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 Manual (Sect. 1(a)) Failure to read this Manual before first use of this device may result in death or serious injury

2.

WARNING: Pre-Use Checks (Sect. 1(a) and 3(a)) To avoid harm to the patient, pre-use checks must be performed before each use.

3.

WARNING: Provision of Alternative Means of Ventilation (Sect. 1(a)) and 4) Always ensure that an alternative means of ventilation is available in the event of ventilator failure or malfunction

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4.

WARNING: Trained Personnel (Sect. 1(a) and 4) To avoid harm to the patient, this equipment should only be used by personnel trained in the use of automatic ventilation. 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

5.

WARNING: Patient Monitoring (Sect. 1(a) and 4(d)) Failure to constantly monitor the patient whilst using this equipment may lead to death or serious injury.

6.

WARNING: Blood gas levels (Sect. 1(a)) Blood gas levels must be monitored independently, correct operation of the ventilator will not necessarily achieve the required blood gas levels. Also, when used at moderate altitude, it is essential that the user closely monitors delivered tidal volume, and measures end-tidal CO2 using suitable capnography.

7.

WARNING: Use of Oxygen (Sect. 1(a), 3(a) and 3(b) 11 ) 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. Avoid smoking or naked flame. 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.

8.

WARNING: Servicing Or Adjustment (Sect. 1(a) and 6(c)) To avoid the risk of harm to the patient from an incorrectly set ventilator, servicing or adjustment of this equipment should only be carried out by competent personnel who have been trained by Smiths Medical to carry out such work.

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9.

WARNING: Use in Aircraft (Sect. 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.

10. WARNING: Use of CMV/Demand Facility (Sect. 2(b), 2(d) #3 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 (Sect. 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. 11. WARNING: Pressure Gauge - non EP Units (Sect. 2(b), 2(d) #11, 2(e) (vii) and 4(d)) Where the non EP version of P20D 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. 12. WARNING: Patient over inflation risk (Sect. 2d) # 4 and Section 4) To avoid the risk of over inflating the patient, because the adjustable relief valve (where fitted) is uncalibrated, initial settings of the relief pressure should always be checked by occluding the patient connection port and observing the pressure displayed on the inflation pressure manometer BEFORE attaching the ventilator to the patient.. It is also very important that the operator constantly monitors the patient pressure manometer during manual ventilation 13. WARNING: Microbial Filter - EP Option (Sect. 2(d) (i) and 2(d) #6) 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.

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14. WARNING: Sensing Line - EP Option (Sect. 2(e) (i) and 2(d) # 6) 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 and loss of patient pressure indication on the manometer. DO NOT use Star Lumen section tubing (see warning 27). 15. WARNING: Use of Alternative Ventilator Patient Circuits (Sect. 2(d) # 9 2(f), 6(c) & 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. Failure to use approved circuits and accessories may lead to unsatisfactory ventilator performance. 16. WARNING: Special Patient Valve (Sect. 2(d) # 11) 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. 17. WARNING: MRI Use (Sect. 2(d)15) (Sect. 2(e) # 15, 2(e) (vi), 4 (f) and Appendix B). 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. 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.

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18. WARNING: Do No Use In Confined Spaces (Sect. 2(d)). 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. 19. WARNING: PEEP Valve Usage (Sect. 2f) vi)) 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. 20. WARNING: Use of Clausen Harness (Sect. 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. 21. WARNING: Functional Check (Sect. 3(b) # 11) 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. 22. WARNING: Use in Extreme Environments (Sect. 4) Extreme environments may impair ventilator performance operator vigilance is required to monitor the patient. 23. WARNING: Adequacy of Gas Supply (Sect. 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. 24. WARNING: Use in Contaminated Atmosphere (1) (Sect. 4(g)) The paraPAC 20D ventilator models are suitable for use in contaminated 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. 504-1116/CE

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25. WARNING: Use in Contaminated Atmosphere (2) (Sect. 4(c) and 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. 26. WARNING: Cross Contamination Risk (Sect. 5(c)) To avoid the risk of cross contamination all re usable components in the patient circuit, that can come into contact with the patient or the patient’s exhaled gas (Patient Valve and Patient Hoses) should be sterilized or disinfected as per instructions detailed in Sections 5d) and 5e) of this user manual. The sterilisation process will also minimise the risk of contaminating the patient with Legionella, which can found in some hospital hot water reservoirs. 27. WARNING: Star Lumen Cross-section tubing (Appendix C) To avoid inaccurate indications on the manometer, DO NOT use star lumen cross section tubing for the sensing line. 28. WARNING:

Routine Replacement Of HME Filter (Sect. 4(e))

If the patient is experiencing breathing difficulties or there are mechanical ventilation problems or decreases in gas exchange and a HME is used, always ensure that there are no blockages in the breathing system. If a blockage is found, immediately replace the breathing system, filter HME. To prevent such problems occurring, filters and HMEs should be routinely replaced in accordance with the manufacturer’s recommendations.

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(b)

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: Although this ventilator has been fully tested to withstand water spray from all directions, it is not designed to be immersed in water. In the event the the module is accidentally immersed, it should no longer be operated and an alternative means of ventilation used (see also warning #19). The ventilator should then be returned to the manufacturer for rectification (Sect. 1(a)). 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. 3(b)11). 3. CAUTION: At low tidal volume settings with 'Air Mix' selected and oxygen as the supply gas the delivered oxygen concentration will be higher than 45% (see Appendix A). The exact rise will be dependent upon the flow setting and the patient compliance and resistance but if the concentration requirement is critical oxygen monitoring equipment should be used (Sect. 4(c)). 4. CAUTION: For this function to operate reliably it is essential that the patient interface device does not leak from atmosphere when subjected to a negative pressure e.g. certain designs of face mask provide a less efficient seal with negative, as opposed to positive pressure (Sect. 4(d)). 5. 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 (Sect. 5(d)). 6. CAUTION : To avoid risk of of internal corrosion within the device, use only dry, filtered gas (Sect. 2(a) & 4(b) ii).

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SECTION 2 GENERAL INFORMATION (a)

Intended Use

The paraPAC 20 & 20D 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*. They are also suitable for ventilation during patient transport. The 20D 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 D) 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. Note: Only the oxygen system is fully calibrated by default, unless specified by the customer on the purchase of the equipment. CAUTION : To avoid risk of of internal corrosion within the device, use only dry, filtered gas (Sect. 2(b) & 4(b) ii). These ventilators are extremely economical in their use of driving gas (use only dry filtered gas) and the 'Air Mix' facility makes them particularly suitable for the long distant transport of patients using bottled oxygen or air. The paraPAC ventilators and associated equipment described in this manual conform to European Standard 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.

*

See Terms and Definitions, Section 10(d)

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(b)

General Description

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 (Sect. 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. The paraPAC ventilator consist of a control module and a remote patient valve, connected by means of a spirally reinforced hose (See Fig 1). The control module is rugged by virtue of its thick section structural foam plastics case and the use of anti-shock mountings for the gauge and internal pneumatics. 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 an FiO2 option of 0.45 or 1.0. The 0.45 FiO2 may be beneficial therapeutically for longer term ventilation 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 P20D 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. On paraPAC 20D, selection can be made between 'Demand' or 'CMV/Demand'. When 'CMV/Demand' 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.

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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 D] 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 (d) 'Mounting Options'. A sling is available to enable the unit to be carried from the user's shoulder. It may also be carried, together with a compressed gas cylinder, within a Pneupac 'Instant Action' carrying case. A wide range of attachments and brackets is also available. The paraPAC may be driven by oxygen or air from a compressed gas cylinder or a pipeline system. (c)

Contraindications

None (d) 1.

Controls and Features (Figure 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 extends beyond that required by the AHA* guidelines in order to give flexibility of use in a wide range of situations. 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. *

See Terms and Definitions, Section 10(d)

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2.

Tidal Volume Control

This rotary control knob gives continuous adjustment of the flow to the patient over the range 6 to 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 specified in the AHA guidelines. For further details refer to Technical Data, Section 10(b). 3. Main Pneumatic Switch (a)

Model 20 only - This knob operates a rotary two position switch to start or stop the ventilator when it is connected to a suitable gas supply.

(b)

Model 20D only - This knob operates a rotary switch to select 'Demand' 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 (Sect. 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. 4. Relief Pressure Control WARNING: To avoid the risk of over inflating the patient, because the adjustable relief valve (where fitted) is uncalibrated, initial settings of the relief pressure should always be checked by occluding the patient connection port and observing the pressure displayed on the inflation pressure manometer BEFORE attaching the ventilator to the patient. It is also very important that the operator constantly monitors the patient pressure manometer during manual ventilation (Sect. 4). 504-1116/CE

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