SMITHS MEDICAL PARAPAC PLUS 310 (01) PDF Document

Before use, all potential users must read the complete User’s Manual and familiarize themselves with the machine and its operation. Failure to read the user’s handbook before first use may result in death or serious injury.

Training: 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.

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

Oxygen Use: 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.

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

WARNINGS:

Use in Aircraft: 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.

Tidal Volumes Below 150mL: 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 may be used.

CMV with Demand Inhibit: Because this function has characteristics specific to this range of ventilators it is important that the sections of the operating instructions describing this facility are read before use so that the operator understands how the ventilator interacts with the patient during spontaneous breathing.

Pressure Sensing Line: Ventilators must never be used without the sensing line attached as this will result in a loss of ‘delivered volume’ to the patient.

Battery for MRI Use: 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.

Patient Circuits: Ensure that only approved circuits supplied by Smiths Medical are used. Failure to use the approved circuits could result in death or serious injury. The patient circuit is a single use device and should be disposed of after each use.

Pre-Use Checks: To avoid harm to the patient, pre-use checks must be performed before each use.

Alternative Ventilation: Always ensure that an alternative means of ventilation is available in the event of ventilator failure or malfunction.

Gas Supply: 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.

Extreme Environments: Extreme environments may impair ventilator performance, operator vigilance is required to monitor the patient.

Use in Contaminated Atmosphere: 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.

Storage in Low Temperatures: 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.

CAUTIONS:

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.

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) position and the battery is removed from its holder.

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.

Do not attempt to sterilise the paraPAC plus or to clean it by immersion in any fluid. Do not use any cream cleanser or petrochemicals. Do not autoclave.

To avoid risk of internal corrosion within the device, use only dry, filtered gas.

1. Unpack the paraPAC plus control module and accessories and check all items against the contents checklist. If any items are missing or incorrect or have become damaged, notify your supplier immediately.

2. Insert the battery into the module battery holder as described in the maintenance section.

3. Connect the breathing circuit to the control module.

4. Connect the input hose to the inlet connector and tighten the securing nut lightly using a spanner (wrench).

Warning: To avoid harm to the patient, pre-use checks must be performed before each use.

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.

1. Check the ventilator controls as follows:

– Function Switch: O OFF DEMAND.

– Frequency: 12 bpm

– Tidal Volume: 700mL

– Air mix Switch (O2 %): ≈ 50

– Relief Pressure: 40 cmH2O

– CPAP / O2 Therapy (Model 310 only): Fully counter-clockwise

– PEEP (Model 310 only): Fully counter-clockwise

2. Connect the pressure monitoring Filter on the patient circuit to the pressure monitoring connector on the ventilator. Caution: Ensure the Filter is securely connected to the sensing line.

3. Connect a breathing circuit to the output connector on the ventilator.

4. Connect the gas input hose to the input connector on the ventilator and secure in place with a spanner (wrench).

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

6. If connected to a cylinder regulator, turn on the cylinder valve slowly.

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

8. Set the Function Switch to I / VENTILATE / CMV. The ventilator should commence cycling and all the visual alarms will flash in turn. The orange silencing indicator should flash for 60 seconds.

9. Allow the ventilator to cycle with no obstruction at the output port and check that the low inflation pressure (disconnect) alarm operates after 10 seconds.

10. Occlude the outlet of the patient valve and check that the manometer gives a reading of between 30 and 50 cmH2O during each inspiratory phase. The pneumatic audible alarm should also sound, accompanied by the high inflation pressure visual alarm. Check that the unit cycles regularly about every 5 seconds.

11. Set O2 (%) switch to 100 and repeat step 10. The difference in the manometer reading should not be more than 5cmH2O from the reading taken in step 10.

12. Set the ‘Tidal Volume’ control to its minimum setting and ensure that the O2 % switch is set to 100. Occlude the output port and check that at least 20 cmH2O pressure is attained on the manometer. Gradually increase the Tidal Volume setting and observe that the pressure increases until the relief pressure is reached.

13. Reset the ‘Tidal Volume’ control to its minimum setting and set O2 (%) switch to ≈ 50. Occlusion of the output port should now cause the manometer to rise sharply to between 30 and 50 x100Pa and the alarms should operate.

14. Set the Frequency control knob to the extreme of its range. By listening to the gas flow, check that the ventilator is responding to the controls and that no irregularities of performance can be observed.

15. Finally, set the controls as specified in step 1 so that the ventilator is left set for emergency use.

This test is for the Model 310 only.

16. With settings as specified in step 1 of the functional check, except the relief pressure which should be set to maximum (fully clockwise), connect patient hose to a 1 Litre Test Lung (not supplied).

17. Turn Function Switch control to I VENTILATE CMV and observe functioning of the test lung.

18. Turn PEEP control fully clockwise and observe the patient pressure manometer which should read between 16 to 24 during the expiratory phase.

19. Return PEEP control to the fully counter clockwise position and the test lung should collapse during expiratory phase and patient pressure manometer should read 0.

20. Turn Function Switch control to O OFF DEMAND.

This test is for the Model 310 only.

21. With settings as specified in step 1 of the functional check.

22. Turn Function Switch control to II FLOW.

23. Turn CPAP control from minimum to maximum then back to minimum and observe increasing then decreasing sound of flow from the CPAP outlet port.

24. Turn Function Switch control to O OFF DEMAND.

25. Finally, set the controls as specified in step 1 of the functional check so that the ventilator is left set for emergency use.

CAUTION: To avoid risk of internal corrosion within the device, use only dry, filtered gas.

1. Connect supply hose probe to dry filtered gas supply.

2. Turn on gas supply (if relevant).

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

4. Turn Function switch to I VENTILATE CMV.

5. Check that the alarm indicators flash in sequence, to indicate correct function.

6. Set ventilation parameters to suit the patient.

7. Briefly occlude the patient connection port of the patient valve with the thumb. Check that the peak inflation pressure reading on the manometer is appropriate for the patient and that the pneumatic audible alarm sounds and the high inflation pressure indicator shows red.

8. Connect face mask or endotracheal tube (ET tube) to patient valve.

9. Check chest movement and Inflation Pressure Manometer to ensure correct ventilation.

10. Check that the green cycle indicator light flashes when inflation pressure rises above 10cmH2O.

11. Make adjustments to the ventilator based upon clinical observation and measurement of expired CO2 and pulse oximetry.

If you are in any doubt about the function or setting of the ventilator, the patient should be immediately transferred to another ventilation device (such as a bag-valve device) until the problem has been resolved.

The demand breathing system allows a spontaneously breathing patient to draw oxygen ‘on demand’ from the gas supply, in any mode and in some cases, cause the ventilator cycling to inhibit.

In I VENTILATE CMV mode: The ventilator delivers the preset tidal volume and frequency. However, if the patient starts to breathe spontaneously with an inspiratory effort of below -2 cmH2O, oxygen from the gas supply can be drawn up to a flow of 120 L/min. If the demand breath volume exceeds approximately 450ml, the ventilator cycling will also be inhibited. At the end of spontaneous breathing, the ventilator recommences cycling after the expiratory time.

In 0 OFF DEMAND mode: The ventilator functions as an oxygen delivery system, delivering 100% oxygen to the patient during each spontaneous breath.

Spontaneous breathing under power failure: Should the oxygen supply fail, the ventilator will not cycle, but the patient can breathe spontaneously through the ventilator since a separate internal ‘spontaneous breathing’ valve opens to atmosphere.

To use the Manual ventilation facility, the function switch must be set to the O OFF DEMAND position.

1. Select the appropriate mask or airway (Endotracheal tube or LM) and connect the breathing circuit. Select the required tidal volume and frequency appropriate for the size of patient and adjust if necessary.

2. With the Airmix switch, select the required oxygen concentration (100% O2 or 50% O2).

3. Set the function switch to O OFF DEMAND position.

4. Ensure a clear airway and correct head position.

5. Depress the MANUAL button on the function switch and listen for flow whilst the button is held, up to the duration set by the tidal volume and frequency.

6. Check patient’s chest movement to ensure correct ventilation.

7. Make adjustments to the controls as necessary.

Pressing the ‘MANUAL’ button delivers a series of single breaths as set by the controls. It is not a purge action and it cannot stack breaths. If a full tidal volume is delivered, the ventilator will ‘lock out’ until the appropriate expiration time has elapsed.

These functions are for the Model 310 only.

Use of CPAP:

1. Connect the CPAP accessory supply tubing to the O2 Therapy / CPAP Therapy barbed connector on the side of the ventilator.

2. Connect the CPAP accessory pressure monitoring tube to the Luer lock manometer connection on the side of the ventilator.

3. Connect the ventilator to a suitable supply of oxygen.

4. Set the function switch to the O2 therapy / CPAP function.

5. Use the Oxygen therapy / CPAP control to adjust the level of the CPAP which is displayed on the inflation pressure monitor (Manometer).

Use of O2 Therapy:

1. Connect the oxygen therapy accessory supply tubing to the O2 Therapy / CPAP Therapy barbed connector on the side of the ventilator.

2. Connect a suitable supply of oxygen to the ventilator.

3. Set the function switch to the CPAP FLOW function.

4. Use the CPAP FLOW control to adjust the level of oxygen flow to the accessory. The range 0.5 to 15 L/min is calibrated for use with free flow oxygen therapy accessories.

After each use:

• Carefully inspect the complete system for damage or contamination and discard single-use accessories.

• Check that sufficient oxygen is available for next use.

• Clean, disinfect or sterilise parts as described below.

• Reassemble the system and carry out the functional check.

• Store the system in a clean, dry area, away from excessive heat or intense light.

Cleaning the Ventilator:

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 petrochemicals to come into contact with the device. Do not autoclave.

The paraPAC plus should only be cleaned with a damp cloth. For obstinate marks a mild soap may be used. Wipe dry immediately with a soft clean cloth. The ventilator may be wiped with a disinfectant but must not be immersed or sterilized.

Care after exposure to dust:

1. Protecting the Gas Inlet and patient outlet from further dust ingress, remove the dust from the device.

2. If a breathing circuit is fitted, remove and dispose of it.

3. If the oxygen input hose is not attached, protect the inlet connection.

4. If necessary, replace the inlet filter.

5. Wipe around the patient outlet port.

6. Fit a new patient breathing circuit.

7. Clean the device and perform a functional check.

Care after being heavily wetted:

1. Protecting the Gas Inlet and patient outlet, dry down the device.

2. If a breathing circuit is fitted, remove and dispose of it.

3. If the Oxygen Input Hose is not attached, protect the inlet connection.

4. If necessary, replace the inlet filter.

5. Fit a new patient breathing circuit.

6. Clean the device and leave it and the hose assembly in a warm (≈30º) and dry environment for 12 hours (approx.). Then run the device in CMV mode for 10 minutes.

7. Carry out the functional check.

Actions after contamination with vomitus:

1. If a replacement breathing circuit is available, remove and discard the contaminated circuit.

2. Fit the new breathing circuit and proceed to step 4.

3. If a replacement circuit is not available: Remove the patient circuit, shake for 20 seconds to remove vomitus, and inspect to ensure the majority of contamination is removed.

4. Confirm the device is functioning correctly by performing a functional check.

The procedure for changing the battery is as follows (see precautions for MRI use):

(i) Ensure the ventilator is off by selecting O OFF Demand on the main function switch.

(ii) Remove the battery cover, situated on the left hand side of the control module, by removing the retaining screw.

(iii) The battery can be removed by pulling on the ribbon.

(iv) Fit the replacement battery, with positive on the right hand side, trapping the ribbon underneath the battery to ease removal on next replacement. Also ensure that the battery removal ribbon is not trapped between the battery and battery holder contact pad.

(v) Replace the battery retaining cover by locating the left hand side tab to the ventilator case first and then refitting the screw.

(vi) Select I VENTILATE CMV on the function switch and check that the alarm system runs through the start-up self-checking procedure.

Actual tidal volume in millilitres delivered at combinations of BPM & Vt knob settings.

Notes:

Actual Frequencies are within ± 20%.

Actual 100% FiO2 Tidal volumes are within ± 20% or ± 50mL whichever is the greater.

Actual 50% FiO2 Tidal volumes are within ± 25% or ± 50mL whichever is the greater.

All tidal volumes are referenced to Standard Temperature and Pressure (STP) i.e. 1013mbar and 21°C for a normal lung of compliance of 0.05 L/cm H2O (C50) and resistance 5cmH2O / L /sec (Rp 5).

Handling and Use:

• ALWAYS take care to fit batteries correctly, observing the ‘plus’ and ‘minus’ signs on the battery and appliance.

• ALWAYS replace batteries in your equipment with the type and size of battery specified by the manufacturer.

• ALWAYS remove dead batteries from equipment and all batteries from equipment you know you are not going to use for a long time.

• ALWAYS keep batteries away from small children. If swallowed seek medical advice immediately.

• NEVER deliberately short-circuit batteries.

• NEVER take apart, crush, puncture or mutilate lithium batteries.

• NEVER bring a damaged cell in contact with water. Lithium metal reacts vigorously with water producing flammable hydrogen gas which can cause a fire.

Storage:

• Batteries should be stored at temperatures between 10°C and 25°C with relative humidity not exceeding 65%.

• To maximise shelf life excessive temperature cycling and storage at temperatures greater than 25°C should be avoided.

• Store unused batteries in their packaging and keep away from metal objects which may cause short-circuit resulting in possible leakage, or in extreme cases an explosion.

Charging 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.

Warning: It is essential that, where this equipment is used in extreme environmental conditions outside those specified in this manual, the operator must exercise particular patient vigilance. Performance will become more uncertain as conditions become more extreme.

Warning: 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.

The table below shows further deviations due to changes in ambient conditions (Typical healthy lung in 100% oxygen setting).

Notes:

1. Nominal values are at local conditions of 20°C and 1013 mBar.

2. At ambient temperature between 0°C and -18°C, the demand tidal volume required to inhibit the automatic cycling can be expected to increase outside the normal limits. Additional user vigilance should be applied in these conditions.

3. Changes are within the general ventilator accuracy stated in this manual.