Pneupac paraPAC medic 200 & 200D Ventilator Users Manual Issue 3 Sept 2002

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paraPAC ‘medic’ 200 & 200D Ventilator User's Manual (including Model Options /MRI and /EP) Table of Contents SECTION 1: SUMMARY AND SAFETY INSTRUCTIONS... 5 (a) Summary Statement... 5 (b) Warnings, Cautions and Precautions ... 5 (i) WARNINGS ... 5 (ii) CAUTIONS ... 9 (iii) PRECAUTIONS ... 9 SECTION 2: GENERAL INFORMATION... 10 (a) Intended Use ... 10 (b) General Description ... 10 (c) Contraindications – none known ... 11 (d) Controls and Features (Figures 1a and 1b) ... 11 e) Options Covered by this Manual ... 18 (i) Model Option ... 18 (ii) Optional Mounting Configurations... 19 (f) Accessories ... 20 SECTION 3: SET-UP AND FUNCTIONAL CHECK... 23 (a) Set Up of paraPAC ‘medic’ ventilator... 23 (b) Functional Check ... 23 SECTION 4: OPERATION... 27 (a) User's Skill ... 27 (b) Setting of Ventilator ... 27 (i) General ... 27 (ii) Ventilating Patient... 27 (c) Use of Air Mix... 28 (d) Use of CMV/Demand facility... 29 (e) Ventilating Intubated Patients... 31 (f) Positive End Expiration Pressure (PEEP)... 31 (g) Use in Contaminated Atmospheres ... 31 (h) Use with MRI (MR Compatibility) ... 32 (i) Instructions for Use Label ... 33 SECTION 5: CARE, CLEANING, DISINFECTION & STERILISATION ... 35 (a) Care... 35 (b) Cleaning... 35 (i) Control Module ... 35 (ii) Patient valve... 35 (iii) Hoses... 36 (c) Disinfection... 36 (d) Sterilisation ... 36 (e) Reassembly and Function Testing ... 36

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SECTION 6: MAINTENANCE ... 37 (a) General... 37 (b) Performance Checking... 37 (c) Changing of Battery... 37 (d) Servicing ... 38 SECTION 7: ACCESSORIES AND SPARE PARTS ... 39 SECTION 8: TECHNICAL INFORMATION ... 41 (a) Principle of Operation... 41 (b) Technical Data ... 44 (e) Explanation of Symbols and Alarm Condition Indicated... 48 (f) Indicated Priority of Audible Alarm Sounds ... 49 (g) MR Compatibility Tests ... 50 (i) Equipment ... 50 (ii) Projectile Risk:... 50 (iii) Ventilator performance tests: ... 50 (iv) Imaging Tests:... 50 (v) Effect of switching gradients ... 50 (vi) Effect of RF fields... 51 (vii)Image quality... 51 Appendix A: Lithium Batteries:... 55 Product Safety, Transportation and Disposal... 55 Appendix B: Calibration accuracies and deviations due to change in ambient conditions ... 61 Appendix C: Cleaning and inspection record log ... 65 List of Figures Figure 1a Front view of paraPAC ‘medic’ ventilator ... 12 Figure 1b Rear and side view of paraPAC ‘medic’ ventilator... 16 Figure 1c: Detachable part of breathing system for demand & non-demand versions ... 18 Figure 2a, 2b& 2c: Model Options ... 19 Figure 2d & 2e: Model Options... 20 Figure 3: Connection of the patient valve / PEEP valve/ Exhaust collector accessories... 20 Figure 4: Schematic diagram of the EP Option assembly ... 21 Figure 5: paraPAC ‘medic’ 200/200D User information Label ... 33 Figure 6a: Principles of operation – non-demand paraPAC ‘medic’ ventilator ... 41 Figure 6b: Principles of operation – demand paraPAC ‘medic’ ventilator ... 42 Pneupac reserves the right to make changes, without notice, which may affect the information contained in this manual. Trademarks: The names "Pneupac", "paraPAC ", "paraPAC 200, "paraPAC 200D", “Smiths” are trademarks of Smiths Group plc.

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SECTION 1: SUMMARY AND SAFETY INSTRUCTIONS (a) Summary Statement The paraPAC ‘medic’ 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 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 that the module is accidentally immersed, it should no longer be operated and an alternative means of ventilation used (see also WARNING Number 19 in this User Manual). The ventilator should then be returned to the manufacturer for rectification. 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: 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 ‘medic’ 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. The paraPAC ‘medic’ 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. 504-1116A_NUS

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WARNING: Failure to read this user’s handbook before first use of this device may result in death or serious injury 2. WARNING: Federal law (USA) restricts the use or sale of this device by, or on the order of, a physician. 3. 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)). 4. WARNING: Failure to constantly monitor the patient whilst using this equipment may lead to death or serious injury. (SECTIONS 1(a) & 4(d)). 5. 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. (SECTION 1(a)). 6. WARNING: Use of Oxygen (Section 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 ‘medic’ ventilator is used so that the operator understands how the ventilator interacts with the patient during spontaneous breathing. 9. WARNING: Pressure Guage observation of non EP version of P200D (Section 2(b), 2(d), 2(e) #20 and 4(d)) 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. WARNING: Direct Patient Inflation Pressure Sensing - EP Option (Sections 2(d) 6 & 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. WARNING: Sensing Line - EP Option (Section 2(d)) 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. 504-1116A_NUS

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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 prevent possible risk of projectile injury within a MRI environment, routinely check for magnetic attraction. 13. 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. 14. WARNING: Special Patient Valve (Section 2(d)20) The patient valve is specially modified to match it to the performance of the paraPAC ‘medic’ 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 ‘medic’ ventilator. 15. WARNING: Provision of Accessories, Ancillaries and Spares for CE marked products. Section 2(f), 6(d) & 7) The paraPAC ‘medic’ 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. 16. 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. 17. WARNING: Functional Check (Section 3(b)13) Deviations noted at functional check should be reported immediately to Pneupac and the unit must be taken out of service to avoid the risk of death or serious injury. 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. 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. 504-1116A_NUS

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20. WARNING: Provision of Alternative Means of Ventilation (Section 4) Always ensure that an alternative means of ventilation is available in the event of ventilator failure or malfunction. 21. 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. 22. WARNING: Interpretation of ‘Breathing Detect’ Indicator (Section 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. 23. WARNING: Use in Contaminated Atmosphere (1) (Section 4(g)) The paraPAC ‘medic’ 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. 24. 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. 25. 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. 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)) WARNING: Use in Extreme Environments (Section 4 and Appendix B) Extreme environments may impair ventilator performance (see Appendix B), operator vigilance is required to monitor the patient.

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28. WARNING: 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). 29. WARNING: 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 Pneupac for installation advice. (Section 2(e) ii)). (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: 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 that the module is accidentally immersed, it should no longer be operated and an alternative means of ventilation used (see also WARNING Number 19 in this User Manual). The ventilator should then be returned to the manufacturer for rectification (Section 1(a)). 2. 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 ‘off’ position and the battery removed (Section 2(d) # 15). 3. 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 (Section 2(d)15). 4. General Precautions Relating to Battery Safety, Transportation and Disposal.See Appendix A. 5. CAUTION : To avoid damge to the EP circuit, detach all EP Circuit parts from the Patient Hose prior to autoclaving. DO NOT autoclave EP Accessories. (iii)

PRECAUTIONS

Precautions warn of actions required to avoid dangerous or undesirable conditions that can occur and cause damage to the ventilator or its accessories, if you do not obey all the instructions given in this manual. 1. PRECAUTION: Protection of Battery and Ventilator During Periods Without Use (Section 2(d)15) To avoid any drain on the battery if the ventilator is unlikely to be used for a long time or is placed in storage, ensure that the main pneumatic switch is left in the Off ('Demand') position. It is also recommended that the battery is removed from its holder to avoid possible corrosion due to leakage of its contents. PRECAUTION: 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. PRECAUTION: General Precautions Relating to Battery Safety, Transportation and Disposal. See Appendix A

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SECTION 2: GENERAL INFORMATION (a) Intended Use The paraPAC ‘medic’ 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 ‘medic’ 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 in rescues from toxic or non respirable atmospheres as it offers the choice of 100% oxygen upon demand 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 ‘medic’ 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 ‘medic’ ventilator is used so that the operator understands how the ventilator interacts with the patient during spontaneous breathing. The paraPAC ‘medic’ 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 ‘medic’ ventilator is given in Section 2(a), the number reference against each description corresponds to the number reference shown in Figure 1a. The paraPAC ‘medic’ ventilator is a gas powered, 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 ‘medic’ ventilator, nor affect the mechanically operated alarms and protection systems. The control module of the paraPAC ‘medic’ 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. * See Terms and Definitions, Section 8 (d). 504-1116A_NUS

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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. On the paraPAC ‘medic’ 200D ventilator, Off ('Demand') and On ('CMV/Demand') can be selected. When On ('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. 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 where 100% oxygen is recommended as the approved therapy and 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 ‘medic’ 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 ‘medic’ ventilator 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 8(d) 504-1116A_NUS

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Figure 1a Front view of paraPAC ‘medic’ ventilator 2.

Tidal Volume Control

This rotary control knob gives continuous adjustment of the flow to the patient over the range 660 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. Model 200D ventilator only - This knob operates a rotary two position switch to select Off ('Demand' only) or On ('CMV*/Demand' facility) which provides controlled mandatory ventilation to non breathing patients, but 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 ‘medic’ 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_NUS

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Selection of On ('CMV*/Demand or I) 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. Selecting the Off ('Demand' or '0') switches the alarm unit off. 4.

Relief Pressure Control This rotary control knob gives continuous adjustment of the maximum patient inflation pressure by setting the relief valve spring loading. It is calibrated to facilitate initial setting but as the peak pressure will also have some dependence upon other parameters the inflation pressure monitor should always be used as the final reference.

5.

Air Mix Control This knob operates a rotary two-position switch to select the 'Air Mix' or the 'No Air Mix' mode. In the 'No Air Mix' position the gas supplied to the ventilator is passed undiluted to the patient whether this be 100% oxygen or compressed air. In the 'Air Mix' mode the ventilator uses a high efficiency entrainment device to mix ambient air with the supply gas in the ratio of approximately 2:1. When supplying oxygen, this means that a mixture containing 45% oxygen is generated and supplied to the patient. When air is used as the driving gas no change of gas composition occurs but advantage can be taken of the 70% reduction in driving gas consumption which is achieved in the 'Air Mix' mode.

6.

Inflation Pressure Monitor This pressure manometer displays the patient inflation pressure, as measured at the ventilator outlet. It will give an accurate indication of the actual patient proximal inflation pressure under all normal settings of the ventilator. It will not display exhalation pressure although this will only be relevant if attachments such as a PEEP valve are added to the patient valve. This arrangement is to be preferred for emergency use because it requires the simplest patient circuit and there is less probability of disconnection occurring as a result of snagging of the circuit. The /EP model option provides external pressure sensing connectors and an external sensing line so that the inflation pressure can be measured at the patient connection point. This may be considered an advantage if the ventilator is to be used mainly for patient transport and PEEP is frequently used. (See Section 2(d)(i))

WARNING: Direct Patient Inflation Pressure Sensing - EP Option (1) 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. WARNING: Direct Patient Inflation Pressure Sensing - EP Option (2) 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.

*See Terms and Definitions, Section 8(d) 504-1116A_NUS

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7.

Supply Gas Failure Alarm This mechanically operated visual alarm gives a warning that the supply gas has dropped to a pressure at which the ventilator will no longer be operating to specification. With low pressure it shows red, with adequate pressure it shows white. Any visible red indicates that the supply should be changed. In most cases the display will begin to oscillate from white to partial red as the supply pressure falls to the lower threshold level. The visual indication will be accompanied by an electronically generated medium priority* audible warning. In order to conserve the battery, if this audible alarm is ignored for more than 60 seconds the alarm system will ultimately switch itself off. 8.

High Inflation Pressure Alarm

An audible alarm is provided to signal that the relief pressure has been achieved and that gas loss is occurring through the relief valve. The alarm is pneumatically operated by means of the gas vented through the relief valve. The pneumatically operated alarm is backed up by a high priority* electronically generated audible and visual alarm. The electronic audible alarm only sounds after alarm pressure has been maintained for a period of 1.0 second in order to avoid the simultaneous sounding of both alarms during transient pressure events. Initially the visual alarm only indicates each time the pressure reaches the preset limit but if high pressure conditions persist the alarm latches to give continuous flashing. Both the audible and visual alarms reset automatically after 10 seconds when the condition is no longer present. 9.

Cycle Indicator During ventilation of the patient the inflation pressure is continuously monitored by a positive pressure detector pre-set to 10cmH2O. Each time the inflation pressure rises through this set pressure level the green Cycle Indicator* flashes for 1/10 second to indicate to the user that, at least, this inflation pressure is being achieved each cycle. 10.

Low Inflation Pressure (Disconnect) Alarm

A medium priority* audible and visual alarm will operate to warn the user of a possible disconnection in the ventilator breathing system or that the ventilator is not cycling correctly if the inflation pressure generated by the ventilator does not rise through the pre-set level of 10 cmH2O at least once in any 10 second period. It should be noted that during normal functioning of the ventilator the generated pressure is always zero during the expiratory phase even if PEEP is applied at the exhalation port of the patient valve. Both the audible and visual alarms reset when the alarm condition no longer exists. 11. Constant Positive Inflation Pressure Alarm A high priority audible and visual alarm will operate to warn the user of a possible danger to the patient if the inflation pressure remains at a positive pressure above the preset pressure threshold of 10 cmH2O but below the set Relief Pressure for a period exceeding 10 seconds unless this is due to the application of high levels of PEEP.

*See Terms and Definitions, Section 8(d) 504-1116A_NUS

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12.

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 (On or '1' selected) all alarms, except the supply gas failure alarm, are automatically suspended although high priority visual alarms will still operate. Any audible alarm can be silenced for a 60 second period, subsequently, by depressing the silencing button but if a new alarm condition occurs during this period it will be immediately annunciated. If the silencing button is depressed pre-emptively, i.e. before any alarm sounds, then only a new high priority alarm condition will cause an alarm to sound during the following 60 seconds.

13.

Breathing Detect Indicator (Model 200D ventilator only) A green visual indicator is used to indicate that a spontaneous breathing effort has been detected by the demand detector in the paraPAC ‘medic’ ventilator. Each time detection occurs the low inflation pressure (disconnect) alarm is reset in the same way as a positive pressure resets the alarm in normal ventilation. This ensures that nuisance alarms do not occur due to the absence of positive ventilation when the patient is breathing spontaneously.

14.

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. When operating at very low temperature the life of the battery will be reduced. * See section 8(e) & (f) for explanation of symbols and description of alarm priorities.

When the alarm is operating normally, as indicated by flashing of either the silencing indicator or one of the two green indicators, the absence of any signal from the low battery indicator confirms that the battery voltage is adequate to operate the alarm system correctly. Refer to Section 6(c) for recommendations concerning battery replacement. 15.

Battery The electronic alarm unit is powered by means of a single cell lithium battery retained in a battery holder on the right hand side of the ventilator. There are two, alternative-sized batteries which can be fitted. For normal use the readily available size 123A 3V lithium battery, as widely used in cameras, can be fitted. However, in MR environments it is essential that the special low ferrous content battery, supplied by Pneupac and marked “For use in MR Compatible ventilators”, is used. This battery is in a size AA packaging but provides 3.6V and has a non-metallic casing. It has been specially selected as having minimal ferrous content such that when installed in the ventilator it produces no noticeable effect. Only this battery should be used when the paraPAC ‘medic’ 200 is used as a MR Compatible ventilator. It must be noted that no battery of this type, commercially available, is completely free of ferrous content and so it must never be removed from the battery compartment of the ventilator in the presence of a magnetic field.

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Figure 1b Rear and side view of paraPAC ‘medic’ ventilator The battery is retained by means of a reversible retaining cap, which is removed by a quarter turn anti-clockwise twist using a coin in the slots provided. During insertion of a new battery the cap should be orientated according to the battery type being used. With the MRI battery inserted, the cap should be fitted with the yellow "MRI" visible after assembly whereas with the standard size 123A battery the "MRI" with a red cross through it should be visible. Lithium batteries have an expected shelf life of 10 years and there is no current drain on an installed battery when the paraPAC ‘medic’ is switched off. Under general use conditions the specified batteries will give at least one year's service before requiring replacement. 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 ‘off’ position and the battery removed. WARNING: BATTERY FOR MRI USE WARNING: 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. WARNING: To prevent possible risk of projectile injury within a MRI environment, routinely check for magnetic attraction. PRECAUTION: To avoid any drain on the battery if the ventilator is unlikely to be used for a long time or is placed in storage, ensure that the main pneumatic switch is left in the Off ('Demand') position. It is also recommended that the battery is removed from its holder to avoid possible corrosion due to leakage of its contents. 16.

Basic Operating Instructions

17.

This panel on the ventilator gives basic operating instructions to assist the infrequent user of the paraPAC ‘medic’ ventilator. It is not intended to replace, in any way, the more comprehensive instructions and information given in this handbook. Alarm Information Label This label provides alarm battery information and a key to alarm signals.

18.

Patient Outlet Connection This outlet to the patient from the ventilator is intended for the attachment of the patient circuit supplied by Pneupac for this purpose.

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WARNING: Failure to use approved circuits and accessories may lead to unsatisfactory ventilator performance. 19.

Patient Hose The patient valve is connected to the control module by means of a spirally reinforced smooth bore ventilation hose. It may be autoclaved at temperatures up to 134ºC. (See Section 5 (d)).

20.

Patient Valve This valve directs the inspiratory flow from the ventilator into the lungs during the inspiratory phase and allows expiration to the atmosphere. The connection to the patient is by means of a 22/15mm co-axial taper fitting so that face masks or endotracheal tubes conforming to the requirements specified in EN 1281-1 may be used. It may be autoclaved at temperatures up to 134ºC. On Model 200D ventilator only, the yellow rubber disc covering the expiratory port serves as a non-return valve to ensure that the patient always inspires from the ventilator and not directly from the atmosphere through this port.

WARNING: The patient valve is specially modified to match it to the performance of the paraPAC ‘medic’ 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 ‘medic’ ventilator. 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. 21.

Inlet Connection A compact, screw type input connection is provided which is specifically designed to take the input hose provided by Pneupac to make a permanent connection. Alternative, gas specific, user detachable connections can be provided by Pneupac if specified at the time of ordering.

22.

Input Hose A range of input hoses is available with alternative connections and probes to suit different gases and Standards requirements.

23.

Carrying Sling Attachments Slots. The carrying sling, W7140, is attached to the control module by means of slots as shown in Fig. 1b.

24.

Mounting Attachment Points Six M5 x 1.0 x 7 deep female threaded bushes on the back of the control module may be used for the attachment of brackets for direct mounting.

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Figure 1c: Detachable part of breathing system for demand & non-demand versions e) (i)

Options Covered by this Manual

Model Option

Direct patient inflation pressure sensing (/EP option) As explained in Section 2(c)6 ventilators supplied against the suffix /EP are arranged to sense the patient inflation pressure directly at the patient outlet connection. The sensing port is mounted in an adaptor which couples to the 22mm taper of the patient connection. The sensing line is connected between the port and a male connector on the side of the paraPAC ‘medic’ ventilator. The line is secured to the patient hose at intervals by means of the clips supplied. 504-1116A_NUS

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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. WARNING: 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. WARNING: 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. (ii) Optional Mounting Configurations The paraPAC ‘medic’ ventilator has been designed to be mounted and carried with a wide range of options as shown in Fig 2. It may be mounted with its base or back on a flat surface as shown in Figs 2 (a) and 2 (b). Alternatively it can be carried on the shoulder by means of the carrying sling.

Figure 2a, 2b& 2c: Model Options For more permanent installations paraPAC ‘medic’ ventilators can be fitted with a rail or polemounting bracket as shown in Fig 2 (d) and 2 (e). The brackets are attached to the back of the control module by means of two M5 x 1.0 socket head fixing screws supplied with the bracket. The rail bracket is of the universal type and attaches to 35/30 mm rails of either 6.5 or 10 mm thickness and of the form shown in Fig 2 (d). A quick release clamp with a screw back up is used. The pole mounting bracket attaches to the module in the same way and accommodates vertical pole diameters of 1/2 - 1" (12 - 26 mm). A screw with a T-handle is used for clamping. 504-1116A_NUS

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Figure 2d

Figure 2e Figure 2d & 2e: Model Options

(f)

Accessories

WARNING: Failure to use approved circuits and accessories may lead to unsatisfactory ventilator performance. (i)

PEEP Valves

The Pneupac patient valve supplied with the paraPAC ‘medic’ ventilator can be fitted with a PEEP valve by means of an exhaust collector (see Fig. 3.) This collector is a push fit onto the body of the patient valve and connects the exhalation ring to a 30 mm male taper connection port without interfering with the function of the valve. Pneupac can supply a compact PEEP valve to fit onto this port with an adjustment range 0-20 cmH2O. PEEP setting is by means of a calibrated adjustment knob. Before using PEEP with the paraPAC ‘medic’ ventilator refer to Section 4 (f) of this Manual.

Figure 3: Connection of the patient valve / PEEP valve/ Exhaust collector accessories (ii)

Breathing Circuit Assemblies

The breathing circuit assemblies are fully assembled. Listed below are the various configurations of the breathing circuit assemblies supplied by Pneupac. Note: Figure 4 and the corresponding table illustrate a typical assembly and the component parts used, but these will vary dependent on the configuration.

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