Pneupac paraPAC plus Model 310 & 300 Users Manual Issue 7 Oct 2012

US Representative: Smiths Medical ASD, Inc. 1265 Grey Fox Road St Paul, MN 55112 USA Tel: 1 800 258 5361 (US/CA) Tel: +1 614 210 7300 Australian Representative: Smiths Medical Australasia Pty. Ltd. 61 Brandl Street, Eight Mile Plains Brisbane, QLD 4113, Australia Tel: +61 (0)7 3340 1300

paraPAC plus Ventilator User's Manual Model 310 & Model 300 Table of Contents SECTION: 1 SAFETY INSTRUCTIONS ... 7 (a) Summary Statement ... 7 (b) Warnings, Cautions and Precautions ... 8 (i) WARNINGS ... 8 (ii) CAUTIONS ... 13

SECTION: 2 GENERAL INFORMATION... 15 (a) Intended Use ... 15 (i) Variants Covered by this Manual... 15 (ii) Variant Features ... 15 (b) General Description ... 16 (c) Contraindications – none known... 17 (d) Controls and Features (Figure 2) ... 17 21 (a) Standard Circuit ... 29 21 (b) Standard Circuit with Mechanical PEEP valve. (Model 300 only) ... 30 (e) Options Covered by this Manual ... 31 (i) Model Option ... 32 (ii) Device Orientation and Installation Options ... 32 (f) Accessories ... 33 (i) Gas Cylinders ... 33 (ii) Cylinder Regulators ... 33 SECTION: 3 SET-UP, FUNCTIONAL CHECK and USE ... 37 (a) Set Up ... 37 (i) paraPAC plus ventilator ... 37 (b) Functional Check ... 38 (i) Pre use function test of the PEEP Function (Model 310 only)... 39 (ii) Pre use function test of the CPAP Function (Model 310 only) ... 40 (c) User's Skill ... 40 (d) Setting of Ventilator... 41 (e) Ventilating the Patient in I VENTILATE CMV. ... 41 (f) Use of CMV & Demand inhibit... 43 (i) Demand breathing system ... 43 (ii) Spontaneous breathing under power failure ... 43 (iii) Manually Ventilating the patient in O OFF DEMAND mode... 44 (iv) Use of CPAP (Model 310 only) ... 45 504-2117

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(v) O2 Therapy (Model 310 only) ... 45 (g) Ventilating Intubated Patients... 45 (h) Positive End Expiration Pressure (PEEP) ... 46 (i) PEEP on Model 300 (Patient Circuit Part No. 100/905/341)... 46 (j) Use in Contaminated Atmospheres... 46 (k) Use in a Magnetic Resonance Imaging (MRI) environment... 47 (l) Use of Air mix ... 47 (m) User Information Label (Figure 9)... 49 SECTION: 4 CARE, CLEANING & STERILIZATION ... 51 a) Care... 51 b) Cleaning , disinfection and sterilisation ... 51 4 b) 1. Ventilator... 51 4 b) 2. Oxygen Input hose... 52 4 b) 3. Care after device is subjected to dust ... 52 4 b) 4. Care after device is heavily wetted... 52 4 b) 5. Care after device immersed in water ... 53 4 b) 6. Actions after contamination with vomitus... 54 c) Reassembly and Function Testing ... 54 SECTION: 5 MAINTENANCE... 55 (a) General... 55 (b) Performance Checking... 55 (c) Changing of Battery... 55 (d) Servicing ... 56 SECTION: 6 ACCESSORIES AND SPARE PARTS ... 57 SECTION: 7 TECHNICAL INFORMATION ... 59 (a) Principle of Operation... 59 (b) Technical Data ... 63 (c) Accuracies... 72 (d) Terms and Definitions... 72 (e) Explanation of Symbols and Alarm Condition Indicated ... 74 Caution 76 (f) Indicated Priority of Audible Alarm Sounds ... 77 (g) MR Conditional Tests ... 77 Appendix A: Lithium Batteries – Product Safety, Transportation and Disposal 83 Appendix B: Calibration accuracies & deviations due to change in ambient conditions... 89 B. 1. 1. Effects Of Inflation Pressure On Delivered Tidal Volume & Oxygen Concentration... 90 504-2117

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B. 1. 2. Increase of delivered nominal FiO2 (≈50%) due to the entrainment of the paraPAC plus PEEP control waste oxygen when ventilating a normal healthy adult lung of airway resistance R5 & lung compliance C50... 91

Appendix C: Inspired Oxygen concentrations when using the ventilator in the O OFF DEMAND mode for spontaneously breathing patients 95 Appendix D: Alternative Input Hoses ... 99 D.1 Alternative Input hoses ... 99 Appendix E: Cleaning and inspection record ... 103

List of Figures Figure 1: General views of the paraPAC plus 310 ... 16 Figure 2.1: Controls, Features & Interfaces of the paraPAC plus 310 ... 17 Figure 2.2: Controls, Features & Interfaces of the paraPAC plus 300 ... 18 Figure 3: paraPAC plus Model 310 Labels and Their Locations ... 35 Figure 4: paraPAC plus Model 300 Labels and Their Locations ... 36 Figure 5: paraPAC plus and Breathing Circuit... 37 Figure 6: paraPAC plus User Interfaces... 38 Figure 7: Selection for Manual Ventilation... 44 Figure 8: Manually Ventilating the patient in O OFF DEMAND mode ... 44 Figure 9.1: paraPAC plus Model 310 User information Label... 49 Figure 9.2: paraPAC plus Model 300 User information Label... 50 Figure 10: Principles of operation of the paraPAC plus ventilator... 62 Figure 11: Charts Illustrating the Effects Of Inflation Pressure On Delivered Tidal Volume & Oxygen Concentration ... 90

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" 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

SAFETY INSTRUCTIONS

(a) Summary Statement The paraPAC plus ventilators are portable devices intended for the ventilation of adults, children and infants (above 10kg) during transportation and emergency situations. They consist of a control module and a remote patient valve, connected by means of a breathing hose. Both pneumatic and electronic alarms are incorporated. Warning: 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 3 of this manual and basic operating instructions are provided on the label affixed to the control module. Warning: Federal (U.S.A.) law restricts this device to sale by or on the order of a physician. Warning: To avoid harm to the patient, this equipment should only be used by personnel trained in the use of automatic ventilation. The equipment should only be used by medical personnel who have a full understanding of the techniques required for its use, or paramedical personnel who have received full and proper initial and 'refresher' instruction from a qualified person, both on resuscitation and on detailed use of the equipment in the situations in which it is likely to be employed. Information given in this manual beyond the basic operation of the ventilator is only intended as a guide to supplement proper medical training and to indicate the specific operational requirements of the paraPAC plus ventilator. Warning: Failure to constantly monitor the patient whilst using this equipment may lead to death or serious injury. Warning: To avoid harm to the patient, blood oxygenation and expired carbon dioxide levels should be monitored independently using pulse oximetry and capnography as part of due clinical diligence. Correct operation of the ventilator will not necessarily achieve the required blood gas levels. 504-2117

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The paraPAC plus ventilator is intended only for use in transport and emergency situations where the patient is being constantly monitored by the carer. The integrated alarm unit is intended to alert the carer to changes in the patient’s ventilation but it cannot ensure that the patient’s blood gases are maintained at the required level. Therefore, patient monitoring devices e.g. a pulse oximeter and other recommended devices should additionally be used where appropriate. (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 (Sect. 1(a)).

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

Warning: Federal (U.S.A.) law Restrictions (Sect. 1(a)).

Federal (U.S.A.) law restricts this device to sale by or on the order of a physician. 3.

Warning: personnel trained (Sect. 1(a)).

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

Warning: Constant monitoring of the patient (Sect. 1(a) & 4(d)).

Failure to constantly monitor the patient whilst using this equipment may lead to death or serious injury. 5.

Warning: blood gas levels (Sect. 1(a)).

To avoid harm to the patient, blood oxygenation and expired carbon dioxide levels should be monitored independently using pulse oximetry and capnography as part of due clinical diligence. Correct operation of the ventilator will not necessarily achieve the required blood gas levels. 6.

Warning: Use of Oxygen (Sect. 2(a) and 3(b)13)

To avoid the risk of ignition, do not smoke or have naked flames in the vicinity of oxygen. Do not allow oil, grease or combustible lubricants (only those approved for oxygen use) to come into contact with any part of the ventilator, regulator or cylinder. 504-2117

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7.

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. 8.

Warning: Tidal Volumes Below 150mL (Sect. 2(b))

Use of the ventilator and Patient breathing Circuit at Tidal Volumes below 150ml may result in a CO2 build up and inadequate ventilation of the patient. For tidal volumes below 150ml the Smiths Medical Hyperinflation Bag system, in conjunction with the CPAP / O2 L/min connector on the ventilator may be used. 9.

Warning: Use of CMV with Demand inhibit Facility (Sect. 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 plus ventilator is used so that the operator understands how the ventilator interacts with the patient during spontaneous breathing. 10. Warning: Direct Proximal Pressure Sensing (Sect. 2(b) #9) Ventilators must never be used without the sensing line attached as this will result in a loss of ‘delivered volume’ to the patient. Although there is no net flow in the sensing line it is recommended that the microbio filter is always fitted to ensure that no patient contamination can enter the manometer circuit within the control module. 11. Warning: Battery for MRI Use (Sect. 2(d)15) To prevent possible risk of projectile injury within a MRI environment, routinely check for magnetic attraction. To avoid projectile risk in a MRI environment, use only the approved MRI conditional battery, Part No: W269-023. Do not attempt to remove the battery from the ventilator (or take a loose battery) in a MRI environment.

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12. Warning: Potential Unsatisfactory Performance with Alternative Ventilator Patient Circuits (Sect. 2(d)18 and 6(d)) Ensure that only approved circuits supplied by Smiths Medical are used with the paraPAC plus range of ventilators. Failure to use the approved circuits could result in death or serious injury. To avoid cross contamination please be aware that the patient circuit is a single use device and should be disposed of after each use. 13. Warning: Provision of Accessories, Ancillaries and Spares for CE marked products (Sect. 2(f), 6(d) & 7). The paraPAC plus ventilator is manufactured and ‘CE’ marked to the requirements of 93/42/EEC. To ensure that this equipment functions as intended, use only the manufacturer’s authorised spares and accessories. 14. 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. 15. Warning: Functional Check (Sect. 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. 16. Warning: Release of Cylinder Pressure (Sect. 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. 17. 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. 18. 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.

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19. Warning: Interpreting of ‘Spontaneous Breath’ Indicator (Sect. 4d) Actuation of the ‘Spontaneous Breath’ indicator only indicates that spontaneous breathing has been detected and that the low-pressure alarm has been reset as a consequence. The operator must still ensure that patient minute ventilation is adequate. 20. 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. 21. 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. 22. Warning: Patient Transportation (Sect. 3) To avoid harm to the patient, inter- or intra-hospital transport should only be undertaken according to established medical practice and under medical supervision. 23. Warning: Projectile Risk (Sect. 4 and Appdx. 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. 24. Warning: Use in Contaminated Atmosphere (1) (Sect. 4(g)) The paraPAC plus ventilator models are suitable for use in contaminated and toxic atmospheres subject to certain limitations as described below and these should be clearly understood by those likely to use the equipment in such environments so that it is only used where appropriate. In any situations where the respirable qualities of the immediate environment are suspect, ventilation should only be carried out in the 100% oxygen (no air mix) mode. This ensures that only a minimum of ambient gas can enter the breathing system. 504-2117

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25. Warning: MRI Use (Sect. 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. 26. Warning: Training Requirements (Sect. 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)) 27. Warning: Regular functional checks for devices in storage (Sect. 4 (a)) To avoid harm to the patient, if the device remains unused for a period exceeding three months, conduct a functional check. 28. Warning: Approved Accessories (Sect. 5 (d)) Failure to use approved circuits and accessories may lead to unsatisfactory ventilator performance. 29. Warning: Lithium batteries (Appendix A) 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. 30. 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. 31. Warning: Storage in Low Temperatures (Appendix B) After storing at temperatures below -18°C set controls to 40 bpm and tidal volume 150mL and connect to gas at higher than 0°C before CMV operation and reset controls as desired once ventilator is cycling. 504-2117

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Warnings specific for the Patient Breathing Circuit

Note: The warnings specific for the Patient Breathing Circuit are listed A.

B.

C. D.

E. F.

(ii)

here for information only. Refer to Instructions for Use part number 100/905/340 and 100/905/341 for the latest information. Users must ensure that they are knowledgeable and proficient in the use of the ventilator and circuit before use to allow them to be used safely. Ensure that the circuit is undamaged, complete, assembled correctly and fully functional before use. Failure to do so could lead to inadequate ventilation. Ensure that all connections are secure. Failure to do so could lead to inadequate ventilation. Ensure that the inline filter is securely attached to the ventilator and that the pressure monitoring line is not kinked. Failure to do so could lead to incorrect or misleading readings on the ventilator’s manometer. Pressure test the circuit before use to verify leak resistance. Failure to do so could lead to inadequate ventilation. Ensure that the PEEP valve is set to the minimum pressure before connecting the circuit to the patient. Failure to do so could lead to patient injury. CAUTIONS

Cautions warn of dangerous conditions that can occur and cause damage to the ventilator or its accessories, if you do not obey all of the instructions given in this manual. 1. Caution: Do not allow any oil or grease to come into contact with the module or, in particular, with the input and output fittings because of the potential fire risk when oxygen is being used. 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 ‘Demand’ (Off) (ventilator off) position and the battery is removed from its holder (Sect. 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. (Sect. 2(d)15).

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4. Caution: Do not attempt to sterilise the paraPAC plus or to clean it by immersion in any fluid. Do not use any cream cleanser. Do not allow any petrochemical or its derivative (petrol, diesel, paraffin etc.) come into contact with the device. Do not autoclave the paraPAC plus. 5. Caution: If the device is accidentally immersed in water or any liquid, it should no longer be operated and an alternative means of ventilation used (see Warning #17). 6. General Precautions Relating to Battery Safety, Transportation and Disposal. See Appendix A. 7. CAUTION : To avoid risk of of internal corrosion within the device, use only dry, filtered gas (Sect. 2(b) & 4(b) ii). Cautions specific for the Patient Breathing Circuit

Note: The cautions specific for the Patient Breathing Circuit are listed here for information only. Refer to Instructions for Use part number 100/905/340 and 100/905/341 for the latest information. a. The PEEP valve has been determined to be MR Conditional ref. (ASTM) F2503-08. There is no projectile risk or change in PEEP performance in a static magnetic field of 3 Tesla or less with spatial gradient magnetic field of 7.5 T/m (750 G/cm) or less. Special care should be taken as follows: MR image quality may be compromised if the area of interest is close to the position of the PEEP Valve. Therefore it should be secured away from the area of interest for the scan. Optimization of MR imaging parameters to compensate for the presence of this device may be necessary. b. If circuit 100/905/341 is used with Model 310 and the circuits PEEP valve is set higher than the value set by the ventilator’s separate PEEP control, the value indicated on the mechanical PEEP valve will be the calibration to follow. At all times, use the ventilator’s manometer to accurately monitor the set PEEP.

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SECTION: 2 (a)

(i)

GENERAL INFORMATION

Intended Use

Warning: To avoid the risk of ignition, do not smoke or have naked flames in the vicinity of oxygen. Do not allow oil, grease or combustible lubricants (only those approved for oxygen use) to come into contact with any part of the ventilator, regulator or cylinder. The ParaPAC plus range are gas-powered emergency and transport portable ventilators that are primarily intended for use in transport applications in vehicles including fixed and rotary wing aircraft. They are suitable for emergency use at the accident scene, intra and inter-hospital transport and within medical facilities including magnetic imaging systems to 3 Tesla. They should only be used under the constant supervision of trained healthcare professionals. The devices are intended to provide ventilatory support for adults, children and infants (above approx. 10 kg). The devices also provide free flow oxygen therapy and CPAP therapy for spontaneously breathing patients. The paraPAC plus ventilators and associated equipment described in this manual conform to International Standard ISO 10651-3 “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. The paraPAC plus model 310 has been determined to be MR Conditional ref. (ASTM) F2503-08. There is no projectile risk or change in ventilator performance within an open bore shielded magnet with a static magnetic field of 3 Tesla or less with spatial gradient magnetic field of 7.5 T/m (750 G/cm) or less. Special care should be taken as follows: If the ventilator is placed at a distance less than 30cm from the area of interest it will affect image quality and could affect the ventilator’s electronic alarms. Therefore it should be secured away from the area of interest for the scan. Optimization of MR imaging parameters to compensate for the presence of this device may be necessary.

* See Terms and Definitions, Section 7 (d).

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Variants Covered by this Manual

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

Variant Features

Feature 8 to 40 bpm Frequency Control 70 to 1500 ml Tidal volume control Air mix control 100% or 50% oxygen concentration Manual breath button Demand oxygen therapy function Demand inhibit of CMV Electronic alarm PEEP Control on ventilator II FLOW control

Model 300 9 9 9 9 9 9 9

Model 310 9 9 9 9 9 9 9 9 9

(b) General Description The paraPAC plus ventilator consists of a control module and a remote patient valve, connected by means of a corrugated hose (See Fig 1). A description of controls and features on the paraPAC plus ventilator is given in Section 2 (d), the number reference against each description corresponds to the number shown in Figure 2. The paraPAC plus ventilator is a gas powered (use only dry filtered gas), time cycled ventilator which depends solely on the pressure of the supply gas for its operation. The models described in this Manual additionally incorporate an integrated electronic pressure alarm unit to alert the user to certain significant changes that may occur in the patient’s ventilation. Loss of battery power for the alarm is signalled to the user but will have no effect on the ventilation performance of the paraPAC plus ventilator, nor affect the mechanically operated alarms and protection systems. CAUTION: To avoid risk of internal corrosion within the device, use only dry, filtered gas. The control module of the paraPAC plus ventilator is rugged by virtue of the design of case, internal pneumatics and electronics. The controls are recessed to minimise the possibilities of damage. Calibrated frequency and tidal volume controls are provided to set the required ventilation pattern and these are clearly colour coded to indicate the recommended settings for adults, children and infants. Used in conjunction with the patient pressure manometer, the PEEP control (Model 310 Only) is provided to set PEEP between 0 and 20 cm H2O. An air mix control gives a FiO2 option of 0.50 or 1.0. For longer term ventilation the 0.50 FiO2 setting will normally be used and in this setting gas consumption is significantly reduced - by almost 70% - giving greatly extended cylinder duration or allowing the use of a much smaller compressor if compressed air is used as the driving gas. On the paraPAC plus ventilator, selection can be made between O OFF DEMAND, I VENTILATE CMV & II FLOW (Model 310 only). When I VENTILATE CMV is selected, the ventilator cycles at the set frequency but if a spontaneous breath is taken during an exhalation phase then this is taken from an internal demand valve. If breathing is at an adequate level for an adult, cycling will be inhibited as long as this breathing level is maintained. If breathing becomes inadequate, CMV will be restored, synchronised with the last breath. Figure 1: General views of the paraPAC plus 310 504-2117

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5

8

9

6

7

10

14

11

12

19

13

20

2

1

4

3

When O 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 an unprotected airway where enhanced oxygen [tidal volume dependent see table in Appendix C] is recommended as the approved therapy. It can also be used to protect a spontaneously breathing patient during rescue from a contaminated atmosphere. The control module is designed to be mounted in a variety of ways as described under Section 2 (e) (ii) 'Mounting Options'. A wide range of attachments and brackets are also available. The paraPAC plus ventilator may be driven by oxygen from a compressed gas cylinder or pipeline system. (c) Contraindications – none known (d) Controls and Features (Figure 2) 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. The frequency range on the paraPAC plus ventilator extends beyond that required by the AHA* guidelines in order to give flexibility of use in a wide range of situations.

Fig. 2a: Frequency Control

22 24

23

21

20

Figure 2.1: Controls, Features & Interfaces of the paraPAC plus 310 504-2117

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*See Terms and Definitions, Section 7(d)

2.

5

Tidal Volume Control (TDEL)

This rotary control knob gives continuous adjustment of the flow to the patient over the range 8 & 39 litres per minute. For ease of use in the emergency situation, it is calibrated in Fig. 2b: Tidal Volume Control 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. For further details refer to Technical Data, Section 7(b). Warning: Use of the ventilator and Patient breathing Circuit at Tidal Volumes below 150ml may result in a CO2 build up and inadequate ventilation of the patient. For tidal volumes below 150ml the Smiths Medical Hyperinflation Bag system, in conjunction with the CPAP / Flow connector on the ventilator may be used (Model 310 only). 3.

8

9

10

11

6

7

14

12

22

21

23

20

2

1

13

4

3

Body Mass Symbols

Fig. 2c: Body Mass Symbols

The colour coded symbols correspond to the Frequency and Tidal Volume controls. These symbols and markings on the controls are for guidance only and are intended to aid in identifying the most appropriate combinations of frequency and tidal volume that the user requires for the particular patient.

Figure 2.2: Controls, Features & Interfaces of the paraPAC plus 300 504-2117

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4.

Function Switch & Manual Push-button

This knob operates a rotary switch to select O OFF DEMAND or II FLOW (this function is only available on Model 310 only, see items 19 and 20 below for details of this function) or I Fig. 2d: Function Switch VENTILATE CMV which provides continuous mandatory ventilation to non breathing patients but allows inhibition of the CMV function 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 plus ventilator is used so that the operator understands how the ventilator interacts with the patient during spontaneous breathing. Selection of I VENTILATE CMV also switches on the visual electronic alarms but for the first 60 seconds of the ventilator operation, the electronic audible is automatically suspended in order to allow time to apply the ventilator to the patient. Selection of O OFF DEMAND switches off the alarm unit.

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5.

Relief Pressure Control

This rotary control knob gives continuous adjustment of the maximum proximal pressure Fig. 2e: Relief Pressure by setting the relief valve spring loading. Control When the proximal pressure reaches this setting, any additional gas is allowed to escape to atmosphere via the relief valve. Also both the electronic (visual and audible) and the pneumatic audible alarms will be activated. 6.

Air mix Control

This knob operates a rotary two-position switch to select the ≈50% oxygen (air mix) or the 100% oxygen (no air mix) mode. In the 100% oxygen (no air mix) position the gas supplied to the ventilator is passed undiluted to the patient. In the 50% oxygen (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 50% oxygen is generated and supplied to the patient. Different lung inflation pressures and the use of the paraPAC plus PEEP control can change the ≈50% oxygen concentration. See Appendix B.1.1.& B.1.2. Fig. 2f: Air Mix Control (O2 %)

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