babyPAC B100 Technical Training Exhalation Valve Advice Guide V1.1 Feb 2017

Introduction This presentation describes the removal, cleaning & re-assembly procedure for an Exhalation Valve Diaphragm (Part No. 510-3043). This procedure will enable the prolonged, continuous use of the babyPAC with minimal interruption to patient ventilation.

Exhalation Valve Exhalation Valve Diaphragm

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MLUTTS babyPAC Exhalation Valve V1.1 26 Feb 2017

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Exhalation Valve parts Equipment Required If you only wish to replace item 2 as shown below (Exhalation Valve Diaphragm Green) please order:

babyPAC™ 100 Diaphragm Kit (510A2911) This comprises of:  

1

babyPAC™ 100 Diaphragm Housing instructions (TB005) Exhalation Valve Diaphragm Green – CE version (Part No. 510-3043)

3 2

To replace items 1 and 2 as shown below please order:   

babyPAC™ 100 Diaphragm Housing Instructions (TB005) Exhalation Valve Diaphragm Green – CE version (Part No. 510-3043) Exhalation Valve Housing Blue - CE (Part No. 510-2590CE)

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Exhalation Valve part number If you wish to replace the entire Exhalation Valve assembly please order: 1

Patient Valve Assembly: 510A2588

2

3

This comprises of: 1. 2. 3. 4.

Exhalation Valve Housing*: 510-2590CE Exhalation Valve Diaphragm: 510-3043 Patient Valve Support: 510-2589 ¼” Dowty Seal – MRI: W5582/MRI 4

*Note: The Exhalation Valve Housing is also known as a Patient Valve Seat, as the Diaphragm Seat is located inside it

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Removing the Exhalation Valve Diaphragm Before removing the Exhalation Valve Diaphragm, please ensure that it is safe to switch off the babyPAC. Procedure > Removal 

Disconnect the return hose that is connected to the Exhalation Valve Housing.



Gently unscrew the Exhalation Valve Housing.

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Remove the green Exhalation Valve Diaphragm (a) off the spigot (b) carefully to avoid damage, i.e. tears and a distortion.

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b

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Cleaning the Exhalation Valve Diaphragm Cleaning

1

3 2

Thoroughly clean the Exhalation Valve Housing (3) and Exhalation Valve Diaphragm (2) either in running hot water or in a detergent solution followed by a thorough rinsing under running water. Dry both parts thoroughly and check them for damage prior to reassembly. CAUTION: Ensure that the valve seat rim (4) is not damaged.

4

A damaged valve seat rim will result in a loss in passive PEEP performance. (PEEP achieved in CMV + PEEP mode).

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Re-assembling the Exhalation Valve Diaphragm Re-assembly

Replace any components that are damaged or worn.

X

WARNING: To avoid the risk of the exhalation valve diaphragm remaining depressed against the valve housing and resulting in continuous pressure loss from the patient circuit, avoid depressing the centre of the diaphragm during fitment. Following the replacement procedure, ensure that the centre of the diaphragm is not depressed and always perform a functional check.

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Quick check for the functionality of the diaphragm Ensure that the Exhalation Valve Diaphragm is correctly mounted on the spigot with the centre raised projection of the diaphragm pointing outwards. At this stage a quick check for the functionality of the diaphragm can be performed as follows-: 1. Ensure that an air or oxygen supply is available. 2. Set the Inspiratory Pressure and PEEP/CPAP controls to the minimum settings.

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Quick check for the functionality of the diaphragm 3. Set the Function Selector Switch to CMV + PEEP and the B100 will commence cycling which in turn will oscillate the diaphragm.

This confirms that the diaphragm has been correctly installed. Position and secure the Exhalation Valve Housing to the fixed part of the Exhalation Valve, ensuring you do not over-tighten the Exhalation Valve Housing (finger tight is adequate). The unit is now ready for a functional check.

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Functional Check

Functional Check WARNING: Any deviations observed in the functional check 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.

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Functional Check The functional check should be carried out to validate that the assembly procedure has been successfully completed and the unit is operating safely. b c Carry out the functional check as follows:

a

1. Set the ventilator controls as follows:a.

Function Selection Switch: 0

b.

Inspiratory Time: 1.0 second e

c.

Expiratory Time: 2.0 seconds

d.

Inspiratory Pressure: 20 x100Pa (20 cmH2O)

e.

Audible High Pressure Alarm: 30 x100Pa (30 cmH2O)

f.

PEEP Pressure: 0

g.

Oxygen Concentration: < 50% (white scale)

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f

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Functional Check

2. Connect the probe(s) on the input hose(s) to an appropriate gas outlet(s). WARNING:

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. Avoid smoking or naked flame. WARNING: 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.

NOTE: The gas source(s) must be capable of maintaining a pressure of at least 305 kPa (≈ 3 bar) whilst delivering a flow of 20 L/min.

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Functional Check 3. If connected to a cylinder regulator(s) turn on cylinder valve(s) slowly. 4. Check that the visual alarm(s) for supply gas failure have changed from red to white (oxygen) or black and white (air). 5. Switch the function selection switch to ‘CMV+PEEP’ or ‘CMV+ACTIVE PEEP’. The ventilator should commence cycling and all the alarm lights flash in turn. A single burst of the high priority audible alarm is given at the same time. The orange silenced indicator should flash for 60 seconds. Check that flow is coming from the patient connection port by feeling the flow when placed close to the back of the hand or to the face. Disconnect (remove) Patient circuit here

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Functional Check

6. Occlude the proximal connection port of the patient circuit and check that the manometer gives a reading of between 15 and 25 x100Pa (15 and 25 cmH2O) during each inspiratory phase. The audible alarm should not sound.

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Functional Check 7. Leaving the high pressure alarm setting at 30 x100Pa (30 cmH2O) set the inspiratory pressure to 40 x100Pa (40 cmH2O). When the proximal connection port of the patient circuit is now occluded the, accompanied by the high inflation pressure visual alarm. pneumatic audible alarm should also sound The manometer should read between 25 and 35 x100Pa (25 and 35 cmH2O). After occlusion for one second, once the silencing period has elapsed, the high priority electronic audible alarm will also sound. Check that the unit cycles regularly about every 3 seconds.

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Functional Check NOTE: After the 60 second initial silenced period the electronic audible alarm will operate if an alarm condition persists. This sound can be silenced for 60 seconds by a single depression of the silencing button. If the alarm condition continues beyond this silencing period, a second depression of the button will be interpreted as an acknowledgment by the operator that the condition is continuous and so the audible alarm for that function is muted. 8. Allow the ventilator to cycle with no obstruction at the output port and check that the low inflation pressure (disconnect) alarm operates after 8 seconds. 9. Set the TI and TE and knobs to the extremes of their range. By listening to the gas flow, check that them ventilator is responding to the controls and that no irregularities of performance can be discerned.

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Functional Check 10. If an oxygen analyser is available the oxygen concentration can be checked at typical settings by connecting the sensor into a tube connected to the patient port at one end and flowing to atmosphere at the other. 11. To check the CPAP function, select CPAP on the function selector switch.

Turn the CPAP control clockwise to the first click of the tactile warning range and then occlude the proximal connection port. The pressure manometer should indicate between 6 and 14 x100Pa (6 and 14 cmH2O).

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Functional Check

12. To check the IMV function, select IMV+CPAP on the function selector switch and set the expiratory time to 1.0 second. The expiratory time should be measured as approximately 10 seconds.

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

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Functional Check CAUTION: 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. WARNING: 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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FAQ: What kind of detergent can I use to clean the Exhalation Valve Diaphragm? What kind of detergent can I use to clean the Exhalation Valve Diaphragm? Regarding advice on the type of detergent to be used when cleaning the “Exhalation Valve Diaphragm” of the Pneupac babyPAC the detergent should have a neutral pH value. Neutral pH value detergent solutions provide the best material compatibility (as opposed to strongly Alkaline or Acidic substances) Please see the link below of an example of a neutral pH detergent: https://my.supplychain.nhs.uk/catalogue/product/fal1017 (Instrument Detergent Enzymatic/Neutral pH neutral enzymatic detergent for automated and manual reprocessing of medical devices (5 litre))

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