Pneupac rescuPAC Users Manual Issue 5 Aug 2010

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rescuPAC User's Manual For rescuPAC 2D and 2DM (Demand Variant) Table of Contents Page SECTION 1: USER’S RESPONSIBILITIES ... 5 SECTION 2: GENERAL INFORMATION... 9 (a) (b) (c) (d) (e)

Intended Use ... 9 General Description ... 9 Controls and Features (Figures 1a & 1b)... 10 Mounting Options ... 13 Accessories ... 14 (i) Instant Action Case ... 14 (ii) Gas Cylinders ... 14 (iii) Cylinder Regulators ... 14 (iv) Oxygen Therapy Unit ... 15 (v) PEEP Valves ... 15 (vi) Clausen Harness and Hook Ring ... 15

SECTION 3: SET-UP and FUNCTIONAL CHECK ... 17 (a)

Set Up ... 17 (i) rescuPAC Ventilator ... 17 (ii) Instant Action Set ... 17 (b) Functional Check ... 19 SECTION 4: OPERATION ... 21 (a) (b)

User's Skill ... 21 Setting of rescuPAC ... 21 (i) General ... 21 (ii) Ventilating Patient ... 21 (c) Air Mix (Model 2DM only)... 22 (d) Use of CMV/Demand ... 22 (e) Ventilating Intubated Patients... 23 (f) Positive End Expiration Pressure (PEEP)... 23 (g) Use in Contaminated Atmospheres ... 23 SECTION 5: CARE, CLEANING & STERILIZATION ... 25 (a) (b)

Care ... 25 Cleaning ... 25 (i) Control Module ... 25 (ii) Patient valve ... 25 (iii) Hoses ... 25 (c) Disinfection ... 26 (d) Sterilization ... 26 504-1115/CE

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(e)

Reassembly and Function Testing ... 26

SECTION 6: MAINTENANCE ... 27 (a) (b) (c)

General... 27 Performance Checking... 27 Service ... 27

SECTION 7: ACCESSORIES AND SPARE PARTS ... 29 SECTION 8: TECHNICAL INFORMATION ... 31 (a) (b) (c) (d) (e)

Principle of Operation ... 31 Technical Data ... 34 Accuracies... 35 Terms and Definitions ... 36 Explanation of Symbols ... 37

APPENDIX A: rescuPAC CALIBRATION ACCURACIES AND DEVIATIONS ... 41 APPENDIX B: CLEANING AND INSPECTION LOG ... 45 LIST OF FIGURES Figure 1a: Controls and Features ... 12 Figure 1b: Controls and Features ... 12 Figures 2a and 2b: Mounting Options... 13 Figures 2c, 2d and 2e: Mounting Options ... 13 Figures 3: Instant Action Case ... 14 Figures 4: PEEP Valve ... 15 Figure 5a: Block Schematic Diagram for Model 2D ... 31 Figure 5b: Block Schematic Diagram for Model 2DM ... 32 Figure 5c: Detachable Part of the Breathing System ... 33

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 and rescuPAC 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: USER’S RESPONSIBILITIES The user must know and observe the instructions in this manual before the equipment is operated. Special attention must be paid to warnings and cautions. All operators should receive a full and proper initial and 'refresher' 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. Information given in this manual beyond the basic operation of the rescuPAC is only intended as a guide to supplement proper training and to indicate the specific operational requirements of the rescuPAC. The rescuPAC is intended only for use in emergency or transport situations where the patient is being constantly monitored by the rescuer. Although use of this ventilator outside the environmental conditions specified in this Manual will not directly lead to a safety hazard the performance will become increasingly uncertain as the conditions become more extreme. Therefore the operator must exercise constant patient vigilance under these conditions. Oil, grease or combustible lubricants, other than those approved for oxygen service, must never be allowed to come into contact with the parts of the ventilator, oxygen regulator or cylinder. Particular care should be taken to avoid any trace of contamination around the oxygen inlet and outlet ports. Oil or Grease readily oxidise and in the presence of oxygen will violently burn. Always connect the ventilator to the regulator before opening the cylinder valve and then open the valve slowly in order to avoid the risk of ignition induced by the heat generated by adiabatic compression. Avoid smoking or naked flame. 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. Servicing or adjustment of this equipment should only be carried out by competent personnel who have been trained for such work. The rescuPAC 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.

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(b)

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 Manual (Section 1(a)) Failure to read this User’s Manual before first use of this device may result in death or serious injury. 2. WARNING: Warnings and Precautions (Section 1(a)) Special attention must be paid to warnings and precautions which are summarised in section 1(b) and (c). Failure to observe the warnings and precautions detailed in this could compromise patient/User safety. 3. WARNING: Trained Personnel (Section 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: Training Requirements (see Section 1(a) and 4 (a)) 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: Provision of Alternative Means of Ventilation (Sections 1(a)) Always ensure that an alternative means of ventilation is available in the event of ventilator failure or malfunction. 6.

WARNING: Provision of Accessories, Ancillaries and Spares for CE marked products (Sections 1(a) and 7) The 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. 7. WARNING: Patient Monitoring (see Section 1(a) and 4 (b)) Failure to constantly monitor the patient whilst using this equipment may lead to death or serious injury. 8. WARNING: Blood Gas Levels (Section 1(a)) 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. 9. WARNING: Use of Oxygen (Sections 1(a) and 3(a)(ii)) To avoid the risk of ignition, avoid smoking or naked flames, 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. Switch on the ventilator, when the ventilator stops, it is safe to release the pin index yoke. 10. WARNING: Potential Unsatisfactory Performance (Sections 1(a)) There is a risk of unsatisfactory performance when alternative Ventilator patient circuits are used. Failure to use approved circuits and accessories may lead to unsatisfactory ventilator performance. 11. WARNING: Use of Clausen Harness (Section 2(e) (vi)) 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. 12. WARNING: Functional Check (Section 3) Deviations noted at functional check should be reported immediately to Smiths Medical International Ltd.

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and the unit must be taken out of service to avoid the risk of death or serious injury. 13. WARNING: Pre-Use Checks (Section 4) To avoid harm to the patient, pre-use checks must be performed before each use. 14. WARNING: Adequacy of Gas Supply (Section 4(b)) 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. 15. WARNING: PEEP valve (Section 4(e)) With a PEEP valve in place the casualty cannot inhale air and therefore these valves should only be used if essential and extra care needs to be taken to ensure that the casualty is not being prevented from breathing at any time. 16. WARNING: Use in Extreme Environments (see Appendix A), Extreme environments may impair ventilator performance operator vigilance is required to monitor the patient. 17. WARNING: PEEP Valve Usage (Section 2e) & 3) 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. With a PEEP valve in place the casualty cannot inhale air and therefore these valves should only be used if essential and extra care needs to be taken to ensure that the casualty is not being prevented from breathing at any time.

(c)

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: Prevention of Gas Loss (Section 3(b)13) 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. 2. CAUTION: Cylinder Change (Section 3(b)) Before changing gas cylinders, turn off the cylinder valve and then switch on the ventilator. After one or two cycles the ventilator will stop and it is then safe to unclamp the pin index yoke without a sudden release of pressure.

(d)

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: 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.

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SECTION 2: GENERAL INFORMATION (a)

Intended Use

The rescuPAC range of emergency ventilators provide easily operated, versatile emergency ventilatory resuscitation equipment suitable for use wherever this may be required. Each model meets the requirement for use during CPR*. The Model 2 units are suitable for the resuscitation of adults and children above 20 kg (approx 4 years). For details of the Non-Demand variant rescuPAC, refer to User’s Manual (Pt. No. 504-1132). The 2D model are especially suitable for the treatment of casualties in rescues from toxic or nonrespirable atmospheres as they offer the choice of 100% oxygen upon demand or ventilatory back-up whilst normal breathing is being restored. rescuPAC ventilators are extremely economical in their use of driving gas and on the 2DM model the 'Air Mix' facility makes it particularly suitable for extended rescues whilst using bottled oxygen or air. The 'Demand' feature available on all models provides a very gas efficient method of treating a victim where 100% oxygen is recommended as the approved therapy, as, for example, in cases of poisoning or decompression sickness. The rescuPAC 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. (b)

General Description

The rescuPAC emergency ventilators consist of a control module and a remote patient valve, connected by means of a spirally reinforced hose. (See Fig 1a). 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. On the Models 2D and 2DM a single calibrated control knob sets the required ventilation pattern and a detent position clearly identifies the setting for ventilation of adults during cardiopulmonary resuscitation (CPR*) in accordance with JAMA guidelines*. On Model 2DM the ‘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 dry air compressor if compressed air is used as a driving gas. On all rescuPAC models selection can be made between 'Demand' or 'CMV/Demand'. When 'CMV/Demand' is selected, the rescuPAC 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. *

See Terms and Definitions, Section 10(d)

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When 'Demand' is selected the internal demand valve, only, 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. The rescuPAC 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 it 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 rescuPAC may be driven by oxygen or air from a compressed gas cylinder or pipeline system. (c)

Controls and Features (Figures 1a & 1b)

1.

Tidal Volume and Frequency Control (Models 2D and 2DM only)

This calibrated rotary control knob gives continuous simultaneous adjustment of tidal volume and frequency over a range of 1450 to 300 ml and 9 to 22 breaths per minute. There is a detent and a heart symbol at the 900 ml, 13b/min setting to give the optimum ventilation pattern for adult cardiopulmonary resuscitation (CPR). A child symbol indicates the recommended initial setting for the resuscitation of smaller children. On all models the delivered tidal volume is relatively unaffected by lung compliance and airway resistance or by switching between 'Air Mix' and 'No Air Mix'. 2.

Main Pneumatic Switch

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. CAUTION: It is particularly important that the sections of the operating instructions describing this facility (section 2(b) and 4(d)) are read before the rescuPAC is used. 3.

Air Mix Control (Model 2DM only)*

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 casualty whether this be 100% oxygen or compressed air. In the 'Air Mix' mode the resuscitator uses a high efficiency entrainment device to mix ambient air with the supply of 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. 4.

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. *

See Section 4(c)

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. 504-1115/CE

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5.

Supply Gas Failure Alarm

This 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. 6.

Basic Operating Instructions

This panel on the rescuPAC gives basic operating instructions to assist the infrequent user of the rescuPAC. It is not intended to replace, in any way, the more comprehensive instructions and information given in this manual and in training programmes. 7.

Patient Outlet Connection

This outlet to the patient from the ventilator is intended for the attachment of the patient circuit supplied by Smiths Medical International Ltd. for this purpose. CAUTION: Although similar circuits could be used in an emergency, mismatching is likely to occur over at least part of the operating range and result in unsatisfactory performance. 8.

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 page Section 5(d)). 9.

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 casualty is by means of an 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. The rubber disc covering the expiratory port serves as a non-return valve to ensure that the casualty always inspires from the ventilator and not directly from the atmosphere through this port. CAUTION: The patient valve is specially modified to match it to the performance of the rescuPAC ventilator and only valves supplied with the units, or bearing the specified part number, should be used. 10.

Inlet Connection

A compact, screw type input connection is provided which is specifically designed to take the input hose provided by Smiths Medical International Ltd. to make a permanent connection. Alternative, gas-specific, user detachable connections can be provided by Smiths Medical International Ltd. if specified at the time of ordering. 11.

Input hose

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

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12

Audible 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. 13

Carrying Sling Attachment Slots

14

Mounting Attachment Points

Six M5x1.0 x 7 deep female threaded bushes on the back of the control module may be used for the attachment of brackets or for direct mounting.

Figure 1a: Controls and Features

Figure 1b: Controls and Features

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(d) Mounting Options The rescuPAC resuscitator 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 on a flat surface as shown in Figs 2 (a) and (b). Alternatively it can be carried on the shoulder by means of the carrying sling as shown in Fig 2 (c). For more permanent installations rescuPAC's can be fitted with a rail or pole mounting 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 30 mm rails of either 6.5 or 10mm 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. a

b

Figures 2a and 2b: Mounting Options c

d

e

Figures 2c, 2d and 2e: Mounting Options 504-1115/CE

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(e)

Accessories (i)

Instant Action Case An Instant Action carrying case can be supplied which is specially designed to carry a rescuPAC ventilator, a 'D' sized gas cylinder and a wide range of accessories. It enables a comprehensive set of pulmonary ventilation equipment to be carried for immediate action at the scene of an emergency. Fig 3 shows the general arrangement of the set, opened out ready for action and complete with the optional gas powered aspirator and an oxygen therapy set. Velcro fasteners are used to ensure easy and reliable access even under the most extreme conditions. Pockets and straps are available for accessories such as PEEP valves, Guedel airways and alternative masks.

(ii)

Gas Cylinders Lightweight aluminium compressed gas cylinders are available from Smiths Medical International Ltd. for use with portable ventilators. The 'D' sized version is suitable for use with the Instant Action Case but they are flat based which permits free standing use also.

(iii) Cylinder Regulators The Pneupac lightweight aluminium regulator is designed to reduce the pressure of high pressure gas cylinders from 137-200 x100 kPa (137-200 bar) to 400 kPa (4 bar) as required by the rescuPAC. It will deliver flow in excess of 60 L/min at this nominal pressure. Pin index or other standard connectors are available for air or oxygen. The regulator is equipped with a protected contents gauge and a quick release check valve which accepts the BS probe on the rescuPAC input hose.

Figures 3: Instant Action Case

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(iv) Oxygen Therapy Unit The Pneupac Oxygen Therapy Unit consists of a flow-regulating 2 metre lead with a builtin filter and disposable face masks. The lead connects to the cylinder regulator outlet connector and delivers 6 litres per minute of oxygen to the mask whose design ensures that the patient receives approximately 4045% oxygen in the mask - 6 litres per minute flow is also available. This lead may also be used with a nebuliser. (v)

PEEP Valves The Pneupac patient valve supplied with the rescuPAC can be fitted with a PEEP valve by means of an exhaust collector (see Fig. 4). 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. Smiths Medical International Ltd. can supply a compact PEEP valve to fit onto this port with an adjustment range of 0-20 x100 Pa (0-20 cm H²O) respectively. PEEP setting is by means of a calibrated adjustment knob. Before using PEEP with the rescuPAC refer to Section 4 (g) of this Manual.

Figures 4: PEEP Valve (vi) Clausen Harness and Hook Ring A Clausen harness and Hook ring can be supplied to strap the face mask to the victim's face for rescue from difficult situations e.g. in tunnel rescue or when hoisting. CAUTION: 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.

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SECTION 3: SET-UP and FUNCTIONAL CHECK (a)

Set Up

(i)

rescuPAC Ventilator Unpack the rescuPAC control module and accessories and check all items against the contents check list. If any items are missing or incorrect or have become damaged notify your supplier immediately. If a carrying sling or mounting bracket has been supplied attach it to the module as shown in Figure 2. Assembly the patient circuit and connect it to the control module as shown in Fig 1 (a). Note that the hose is attached to the fixed taper limb of the patient valve which is at an angle to the body. The mask is attached to the swivel taper. Connect the input hose to the inlet connector as shown in Figure 1(a) and tighten the securing nut lightly using a spanner (wrench). The probe on the input hose is gas specific to the standard specified when ordering. Any of the Pneupac hoses listed in the rescuPAC ordering information can be used with the ventilator provided the same inlet connection is specified.

(ii)

Instant Action Set Unpack the equipment and lay out the contents so that each component is identified. Make reference to the illustration (Fig 3) for the stowage of all items. Lightweight aluminium Pin Index 'D' size cylinders may be purchased from Smiths Medical International Ltd..

WARNING: NO OIL OR GREASE OF ANY KIND MUST BE ALLOWED TO COME INTO CONTACT WITH HIGH PRESSURE OXYGEN! AVOID SMOKING OR NAKED FLAME! (See Page 4) Remove plastics wrapper from cylinder valve. Momentarily turn on cylinder using cylinder valve key/wheel to blow out any dust in cylinder valve. Fit regulator and yoke (7) to the cylinder valve, making sure the sealing washer is in position and the two foolproofing locating pins are entered in the side of the square cylinder valve. Tighten the T screw in the yoke making sure that the screw's pointed end is in the recess of the cylinder valve. Where a regulator with a threaded cylinder connection fitting is provided, screw the fittings onto the threaded connection of the cylinder, tightening with the regulator in the correct orientation to fit the case. Slowly open the cylinder valve anti-clockwise using the cylinder valve key/wheel. Once the contents gauge pointer has stabilised, open the cylinder fully then close the valve one quarter of a turn to enable subsequent users to distinguish between an open and closed valve. Check that gas does not leak audibly from the connection or from the gland nut on the cylinder valve. If leaking, check that the previous fitting instructions have been carried out properly and that the sealing washer is in position and is not damaged. If leaking from gland nut, replace the cylinder and defer the faulty cylinder via the normal reporting channel.

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WARNING: Always turn cylinders on slowly to avoid the risk of fire resulting from the heat which can be generated by adiabatic compression. A pressure gauge is provided to check the contents of the cylinder. Check level of charge. If the gauge indicates empty, check that the connection has been made according to above; otherwise replace with new cylinder. Close cylinder valve. Place cylinder into the cylinder sleeve (8) in the Instant Action Carrying Case and adjust the flaps by means of the Velcro fasteners as required to secure cylinder. For the correct positioning of the cylinder see Fig. 3. Connect to the control module (1) the threaded end of the input hose (5) and tighten the securing nut lightly using a spanner. Connect the output hose (6) as indicated by signs on the module. Connect the other end of the output hose to the fixed side limb of the patient valve (2). Fit mask onto the taper of the swivelling mask adaptor limb of the patient valve. different size masks are provided, fit the size most likely to be used.

If two

Insert the probe on the input hose firmly into the bore of the outlet connector on the regulator. Make sure the probe is locked into position. Attach control module to side of case by means of the two thumb screws provided. Coil hoses neatly so that case can be closed up without distorting them unduly. Stow Guedel airways (11) in the individual elastic loops provided. Coil and stow shoulder strap in the end loop. Stow accessories as provided - the spare mask and Clausen harness in the loops, the antiinhalation valve, PEEP valve and any other items in the shallow side pocket. Place Oxygen Therapy Set in the large side pocket. For details of accessories see Section 2(e). Place this Manual in the central pocket (4) for use and reference.

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(b)

Functional Check

The following procedure should be followed when first setting up the ventilator to check that it has been assembled correctly and is operating safely. It should be repeated periodically as specified under 'Maintenance'. 1.

Set the ventilator controls as follows:Main Pneumatic Switch:

'Demand'

Tidal Volume/Frequency:

900ml/13b/min (detent position)

Air Mix Switch (2DM only):

'No Air Mix'

2.

Connect the probe on the input hose to an appropriate gas outlet.

3.

NOTE: The gas source must be capable of maintaining a pressure of at least 305 kPa ( 3 bar) whilst delivering a flow of 45 L/min. If connected to a cylinder regulator turn on cylinder valve slowly.

4.

Check that the visual alarm for supply gas failure has changed from red to white.

5.

Switch the main pneumatic switch to 'CMV/Demand'. The ventilator should commence cycling. Occlude the output port on the patient valve and check that the audible alarm sounds. Check that the unit cycles regularly about every 5 seconds. Note the pressure indicated on the manometer.

6.

Switch over to 'Air Mix' and repeat step 5. The change in the manometer reading should not exceed 5 x100 Pa (5 cmH²O).

7.

Set the Tidal Volume/Frequency control knob to the extremes of its range. By listening to the gas flow, check that the ventilator is responding to the control and that no irregularities of performance can be discerned.

8.

Finally, set the controls as specified in step 1 so that the ventilator is left set for emergency use. CAUTION: Any deviations observed in the above checking should be reported immediately to your supplier, or an authorised service engineer, and the ventilator should not be used until a more thorough check has been completed. CAUTION: It is good practice to turn off the valve on the gas cylinder after use to ensure that the cylinder contents are not lost during storage due to small leakages. CAUTION: Before changing gas cylinders, turn off the cylinder valve and then switch on the ventilator. After one or two cycles the ventilator will stop and it is then safe to unclamp the pin index yoke without a sudden release of pressure.

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