SMITHS MEDICAL PARAPAC PLUS 300 (01) PDF Document

The SMITHS MEDICAL PARAPAC PLUS 300 is a gas-powered emergency and transport portable ventilator. Its primary intended uses include:

• Use in transport applications in vehicles, including fixed and rotary wing aircraft.

• Emergency use at accident scenes, during intra and inter-hospital transport, and within medical facilities.

• Providing ventilatory support for adults, children, and infants (above approx. 10 kg).

• Providing free flow oxygen therapy and CPAP therapy for spontaneously breathing patients.

It should only be used under the constant supervision of trained healthcare professionals.

The SMITHS MEDICAL PARAPAC PLUS 300 should only be used by personnel trained in the use of automatic ventilation. This includes:

• Medical personnel who have a full understanding of the techniques required for its use.

• 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.

Federal (U.S.A.) law restricts this device to sale by or on the order of a physician. It is critical that all potential users read the complete User’s Manual and familiarize themselves with the machine and its operation before first use.

To set up the SMITHS MEDICAL PARAPAC PLUS 300 ventilator, follow these steps:

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

2. Insert the battery into the module battery holder as described in the “Changing of Battery” section.

3. Connect the breathing circuit to the patient outlet connection on 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 functional check should be performed when first setting up the ventilator and periodically as specified under ‘Maintenance’.

1. Set 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 (40 x100Pa)

2. Connect the pressure monitoring Filter on the patient circuit to the pressure monitoring connector on the ventilator. 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 and secure it 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. The gas source must be capable of maintaining a pressure of at least 280 kPa (≈ 2.8 bar) while delivering a flow of 40 L/min.

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 start cycling, and all visual alarms will flash in turn. A single burst of the high priority audible alarm is given. 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. Check that the manometer gives a reading between 30 and 50 cmH2O during each inspiratory phase. The pneumatic audible alarm and the high inflation pressure visual alarm should activate. After one second of occlusion (and after the silencing period), the high priority electronic audible alarm will also sound. Check that the unit cycles about every 5 seconds.

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

12. Set the ‘Tidal Volume’ control to its minimum setting and ensure the O2 % switch is set to 100. Occlude the output port and check that at least 20 x100 cmH2O pressure is attained. 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 and set the O2 (%) switch to ≈ 50. Occluding 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 extremes of its range. Listen to the gas flow to check that the ventilator responds to the controls without irregularities.

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

Warning: Deviations noted during the functional check should be reported immediately, and the unit must be taken out of service to avoid risk of death or serious injury.

To ventilate a patient in I VENTILATE CMV mode, follow these steps:

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

2. Turn on the gas supply (if relevant).

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

4. Turn the 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 your 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 the face mask or endotracheal tube (ET tube) to the patient valve.

9. Check chest movement and the 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. Keep the patient’s condition, chest movements, and the inflation pressure monitor under constant observation.

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 patient’s size, adjusting 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. Hold the button for a duration up to that set by the tidal volume and frequency controls.

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

7. Make adjustments to the controls as necessary.

Pressing the ‘MANUAL’ button delivers single breaths as set by the controls. It is not a purge action and cannot stack breaths. If a full tidal volume is delivered, the ventilator will ‘lock out’ until the appropriate expiratory time has elapsed. If a shorter breath is delivered, further breaths can be delivered until the total tidal volume is reached, after which the unit will ‘lock out’.

The demand breathing system allows a spontaneously breathing patient to draw oxygen ‘on demand’ from the gas supply. This can inhibit the ventilator’s cycling in certain conditions.

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

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

Note: The demand breathing system does not inhibit cycling if the patient takes frequent small panting breaths, as the volumes demanded may be insufficient to inhibit the ventilator. Actuation of the ‘Spontaneous Breath’ indicator only shows that spontaneous breathing has been detected; the operator must still ensure that patient minute ventilation is adequate.

If the device is adversely affected by dust, return it to use as follows:

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, protect the patient outlet from further dust ingress, then remove and dispose of the breathing circuit.

3. If the oxygen input hose is not attached, protect the inlet connection from further ingress of dust.

4. If necessary, replace the inlet filter as described in the service manual (part no. 504-2049).

5. Wipe around the patient outlet port, taking care not to cause dust to enter the device.

6. Fit a new patient breathing circuit.

7. Clean the device in accordance with standard cleaning procedures.

8. Carry out the functional check and pre-use check as described in the manual and run the device for 10 minutes.

If heavily wetted:

1. Protecting the Gas Inlet and patient outlet from further ingress of water, dry down the device.

2. If a breathing circuit is fitted, protect the patient outlet from further water ingress, then remove and dispose of the breathing circuit.

3. If the Oxygen Input Hose is not attached, protect the inlet connection from further ingress of water.

4. If necessary, replace the inlet filter as described in the service manual (part no. 504-2049).

5. Fit a new patient breathing circuit.

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

7. Carry out the functional check and pre-use check.

If immersed in water:

Caution: If the device is accidentally immersed in water or any liquid, it should no longer be operated. An alternative means of ventilation must be used. The device must be returned to the manufacturer for a full safety evaluation.

1. If the oxygen input hose is not attached, protect the inlet connection from further ingress of water.

2. Remove the input hose, shake it dry, and blow through it with oxygen from the gas supply.

3. Shake the device to remove excess water.

4. Protecting the patient outlet from further water ingress, dry down the device.

5. Remove (if connected) and discard the patient breathing circuit.

6. Leave the device and hose assembly in a warm (≈30º) and dry environment for 12 hours (approx.).

7. Place the device in a polythene bag and seal it. Label the bag with all relevant information.

8. Dispatch the package to the manufacturer.

If the device is adversely affected by vomitus, follow these steps to return it to use:

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

2. Fit the new breathing circuit. Proceed to step 4.

3. If a replacement breathing circuit is not available:

i) Remove the patient circuit from the patient.

ii) Shake for approximately 20 seconds to remove the vomitus.

iii) Inspect to ensure the majority of contamination has been removed from the patient circuit.

iv) Proceed to step 4.

4. Confirm the device is functioning correctly as described in the functional and pre-use check sections of the manual.

5. Use of this cleaned circuit is only permitted on the same patient in its current status.

Warning: To avoid cross-contamination, the patient circuit is a single-use device and should be disposed of after each use.

To change the battery, follow this procedure:

1. Ensure the ventilator is off by selecting O OFF Demand on the main function switch.

2. Remove the battery cover, located on the left hand side of the control module, by removing the retaining screw.

3. The battery can be removed by pulling on the ribbon.

4. Fit the replacement battery, with the positive side on the right hand side. Trap the ribbon underneath the battery to ease removal on the next replacement. Ensure the battery removal ribbon is not trapped between the battery and the battery holder contact pad.

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

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

Note: If the low battery alarm operates while ventilating a patient, the battery can be replaced, but care should be taken to minimize the time that electronically alarmed ventilation is interrupted. Battery failure does not affect the pneumatic ventilation functions.

To ensure safety in an MRI environment, follow these precautions:

• Check for Magnetic Attraction: To prevent projectile injury, routinely check the ventilator system for magnetic attraction whenever the equipment is taken into an MRI environment to ensure magnetically attracted parts have not been added inadvertently.

• Use Approved Battery: To avoid projectile risk, 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 into an MRI environment.

• Monitor Ventilation: When in use, check the pressure manometer to confirm unchanged ventilation.

• Test Alarms: Test the high-pressure relief/alarm system by temporary circuit disconnection and occlusion of the ventilator outlet connector. This test should be done whenever the system is taken into an MRI environment and every time the patient is positioned within the magnetic field.

• Maintain Distance: If the ventilator is placed less than 30cm from the area of interest, it can affect image quality and electronic alarms. Secure the ventilator at least 30cm away from the area of interest for the scan.

Handling and Use:

• ALWAYS fit batteries correctly, observing the ‘plus’ and ‘minus’ signs.

• ALWAYS replace batteries with the type and size specified by the manufacturer.

• ALWAYS remove dead batteries from equipment promptly.

• 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, as it can produce flammable hydrogen gas.

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.

Storage:

• Store batteries at temperatures between 10°C and 25°C with relative humidity not exceeding 65%.

• Store unused batteries in their packaging and keep them away from metal objects that could cause a short-circuit.

Disposal:

• As they contain no mercury, lead, or cadmium, their disposal is not regulated by EU Directive 91/157/EEC. However, local regulations may be more stringent.

• In the absence of specific guidelines, up to five lithium batteries can be disposed of with other general waste.

* Refer to Appendix D for alternative country specific Oxygen input hoses.

The actual tidal volume in millilitres delivered at combinations of BPM and Vt knob settings is as follows:

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).

Warning: When 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. Reset controls as desired once the ventilator is cycling.

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 automatic cycling can be expected to increase outside the normal limits. Additional user vigilance should be applied.

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