babyPAC B100 Technical Training Testing Advice Guide V1.0 April 2017

Introduction

This presentation describes the processes for Testing the Pneupac babyPAC.

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Equipment Required Equipment Required – ordered via Smiths Medical New Part Number

Comments

TSI Certifier FA Plus ratePAC is no longer available for sale 500A82803

BACKPRESSURE DEVICE

500-82803/2

Gauge & Elbow Assy

W7038

Oxygen Analyser POM60

500-84250

BABYPAC TEST LUNG ASSY

500-82978

PIPELINE ISOLATION SWITCH

W1299

22MM BLK HOSE 300mm LONG

W7483

CORRUGATED TUBE 1067MM

504-24

WARNING DO NOT USE LABEL

500-82073

Pac Knob Spanner

For babyPAC series, use TSI Certifier FA Plus as per "BabyPAC Service Bulletin 2016-001"

EA

OBS* NOW USE W1299 > 1/EA

Additional Equipment Required – ordered via 3rd Party 1 x TSI Certifier FA Plus

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babyPAC B100 Service Record Sheet Service Record Sheet Use the babyPAC B100 Service Record Sheet to record results taken during testing

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babyPAC Controls Overview Independent, adjustable, pneumatic, high pressure alarm 12-80 cmH2O

Monitor Module Incorporating patient pressure manometer and illuminated visual alarms / indicators

Separate controls for inspiratory and expiratory times Inspiratory Time = 0.25 seconds to 2 seconds Expiratory Time = 0.25 seconds to 4 seconds (on IMV, E Time = 2.5 seconds to 40 seconds)

Four Operating Modes: •CMV +PEEP •CMV +ACTIVE PEEP •IMV + CPAP •CPAP

Supply Gas Failure Indicator Oxygen

Supply Gas Failure Indicator Air

Unique variable concentration gas mixing system Oxygen concentrations between 21% and 100% can be selected. With O2supply Only = 45 -100% With Air supply Only = 21% With O2 & Air Supply = 21% -70%

PEEP/CPAP Control With click action warning at & above 10 cmH2O. 0-20 cmH2O on CMV + PEEP only. 3 -20 cmH2O on CPAP & CMV + Active PEEP

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Inspiratory Pressure Control 12-70 cmH2O With click action warning at & above 40 cmH2O

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Alarms and indicators - Overview babyPAC alarms and indicators High Pressure Indicator Flashes red, with audible alarm, at set alarm pressure and with continuous positive pressure

Normal Cycle Indicator Flashes green each time inflation pressure rises through 10 x100Pa

Low Pressure (disconnect) Indicator Flashes yellow, with audible medium priority alarm, if pressure does not rise through 10 x100Pa (10cmH2O) within 7.5 seconds

Patient Inflation Pressure Monitor Indicates from -10 to +100 x100Pa (-10 to +100cmH2O)

Silence/Mute Button Silences audible alarm for 60 seconds

Low Battery Indicator Provides both visual low voltage indication as early warning and battery failure alarm (visual and audible)

Single Gas Operation Indicator Flashes green whenever the ventilator is operating on a single gas supply (oxygen or air only)

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Silenced/Muted Indicator Flashes orange to indicate alarm silenced or muted

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1: Input Hoses Check the condition of the Input Hoses

i) From 1st January 2002 pressure hoses are date coded and should be replaced after 5 years. Check the label on hose for replacement date. ii) Check that there is no internal damage to the hose by feeling the rigidity of the hose and looking for sloppiness. O2 – O Ring

Medical Air

iii) Ensure there is no delamination of the hose, no blisters or bubbles on the surface (check again when the hose is pressurised) and no cuts or damage.

iv) Check union ends for signs of kinking and/or damage to hose or union. v) Check the O-ring (W5520) on the ventilator end of the oxygen hose and replace if damaged.

Replace the relevant hose if any of above is apparent. 7 - SMITHS CONFIDENTIAL -

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2: Check the condition of the Patient Circuit Check the condition of the Patient Circuit i) Check the condition of the Patient Circuit for hardening, damage, splits or small holes in the hose wall. ii) Check the connectors for excessive scoring and damage.

Patient Circuit Reusable

iii) If any defects are found, discard the Patient Circuit and replace with a new one. iv) Check the Facemask (if fitted) for damage and splits.

Patient Circuit One time use only

v) Check that the Facemask fits correctly to the 15mm female ‘Y' connector where applicable.

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3: Check the condition of the babyPAC (including replacement of battery) Check the condition of the babyPAC (including replacement of battery) i)

a. b. c. d. e.

Check the Control Module looking for damage to: the gauge and surround the gas supply indicators the gas input and output fittings the control knobs the case and labels

ii) Check that input and output connections are secure. Tighten if necessary

d

b a

c

Rear

e

iii) Check that the input connector filters are clean. iv) Check that the air intake filter is clean, unblocked and secure.

Right Side – Note the “MRI battery compartment”

Top

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The gas input and output fittings - Detail Audible High Pressure Pneumatic Alarm

Air Supply Gas Inlet Connection

Patient Circuit Connection 22 mm Male 15 mm Female (ISO 5356)

Air Entrainment Port

To the Patient

Oxygen Supply Gas Inlet Connection

Gas Return Port Expirator Port From the Patient

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3: Check the condition of the babyPAC (including replacement of battery) - Continued Check the condition of the babyPAC (including replacement of battery) Continued v) If any of the filters is dirty then it should be replaced. First remove the relevant connector and seal from the Control Module. The oxygen supply and air intake filters can be replaced by removing the O-ring (W5520). The conical filter (W9151) should now be pushed from the connector. Both O-ring and filter should be replaced.

The air input connector has a retaining circlip holding both O-ring and disc filter. Drive the filter, O-ring and circlip out of the fitting using a 5mm punch. Fit new disc filter (W9158) and O-ring (W5523) then insert a new special retaining circlip (W6487) pushing it down onto the face of the O-ring using a 6mm punch. Refit the connector/s with a new sealing washer (W5582/MRI).

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3: Check the condition of the babyPAC (including replacement of battery) - Continued Check the condition of the babyPAC (including replacement of battery) - Continued vi) Check that the control knobs move smoothly, are not loose on spindles and do not rub on the front panel. If spindles are bent the knob may rub on the faceplate on one side only. vii) Check that the knob caps are affixed firmly to the knob, align with the index mark on the knob side, and cannot be rotated, relative to the knob, during normal operation. viii) Rotate each knob to its extreme limits to verify that the knob has not moved on its spindle. ix) The TINS and the TEXP knobs should align exactly with both ends of the calibration marks, i.e. at 0.25, 2.0 seconds for TINS, and 0.25, 4.0 seconds for TEXP. x) The O2 concentration knob index mark should be equally spaced from each end of the yellow calibration scale. xi) PEEP/CPAP and Inspiratory controls should align closely with the calibration marks at the extreme positions but should also just enter the red segment of the calibration mark when each knob initially comes into contact with the rumble strip at their intermediate positions.

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3: Check the condition of the babyPAC (including replacement of battery) - Continued Check the condition of the babyPAC (including replacement of battery) - Continued

xii) The Pressure Alarm control knob should align with the extremes of the calibration marks. xiii) The dot on the Function Selector switch should align with the marks on the panel at each selection and there should be no intermediate positions. xiv) If the index mark on any knob side or the cap end is misaligned it should be corrected before further calibration checks are carried out. xv) To relocate the knob position for controls (except the Pressure Alarm and Function Selector) first remove the end cap from the knob. xvi) Turn the knob nearly to the end stop at which it is at its maximum height above the panel (timer controls at minimum time, pressure controls at maximum pressure and O2 Concentration control at 100%) in order to minimise possible needle/seat contact during knob removal.

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3: Check the condition of the babyPAC (including replacement of battery) - Continued Check the condition of the babyPAC (including replacement of battery) - Continued

xvii) Using an appropriate collet spanner (e.g. 500-82073) and supporting the knob by hand in order to minimise any axial thrust on the spindle, release the knob from the spindle. xviii) Set the TINS and TEXP spindles against their 0.25 second stops and replace the knobs onto the spindles. xix) Maintaining a gap to the face panel of 0.4/0.5 mm and correct alignment at the 0.25 second calibration, gently retighten the knob collet using only a rotary action. Check that the knobs align with the scale at both ends. xx) Rotate the knobs until they are just backed-off from the maximum time stop and then tighten the collet screw as tightly as possible with recommended tool (500-82037) while simultaneously supporting the knob by hand to minimise the force applied to the spindle. xxi) Repeat the above procedure for the O2 Concentration control but using a minimum gap to the panel of 0.4/0.5mm and making the initial settings at the minimum concentration calibration. Check that the knob is located as in x) above. Finally tighten just short of the maximum calibration position.

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3: Check the condition of the babyPAC (including replacement of battery) - Continued Check the condition of the babyPAC (including replacement of battery) - Continued

xxii) Finally repeat the above procedure for the PEEP/CPAP and Inspiratory Pressure controls but making the initial settings at the minimum pressure calibration. Check that the knobs are located as in xi) above and then finally tighten just short of the maximum pressure settings. xxiii) With the knobs in the final re-tightening position refit the knob cap ensuring the line on the cap aligns with the line on the side.

xxiv) The Pressure Alarm and Function Selector switch knobs have a fixed location but the cap can be relocated on the front of the knob if the indication is incorrect. xxv) If the caps on the above knobs have been removed for relocation or can be rotated, relative to the knob, during normal operation they should be secured to the knob with a very small drop of adhesive (DS354 C10/Loctite Prism 460). xxvi) Check that the gauge surround is secure, the front panel label is secure and not damaged (e.g. punctured) and the silencing button is undamaged.

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3: Check the condition of the babyPAC (including replacement of battery) - Continued Check the condition of the babyPAC (including replacement of battery) - Continued xxvii) Check that the gauge is in the correct vertical position and has not rotated in the shroud. xxviii) Ensure that the battery cap is fitted in the correct orientation to suit the type of battery installed (type 123A or MRI).

Note: Battery cover is reversible for use with non MRI battery

xxix) Remove the existing battery and check when battery was last changed. If 12 months or more has elapsed, insert a new battery of the correct type. If the ventilator is being used or is likely to be used in an MR environment, ensure that battery part no. W269-023 is used. If service interval is less than 12 months, mark the battery, or service log for the ventilator, with the date of replacement. xxx) Replace any damaged labels. xxxi) Check that any accessories or spares added are MR Compatible. 16 - SMITHS CONFIDENTIAL -

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4: Check the condition of the Exhalation Valve element Check the condition of the Exhalation Valve element i) Remove the rubber Valve Element from the Exhalation Valve by unscrewing the Valve Connector/Housing and easing the Element away from its location spigot (the Element may remain inside the housing, see left below, and then should be eased out gently). ii) Ensure that the Valve base is tightly screwed into the manifold. iii) Pull the Valve Element lightly between fingers and hold in front of light to check for splits or pinholes. Replace the Element if there is any defect. iv) Ensure that the Valve Element is perfectly clean. It may be cleaned in warm soapy water but must be dried thoroughly before replacing.

v) Inspect the seat edge within the Valve Housing for damage. Replace if damaged. vi) Refit the Valve Element to its spigot with the centre raised portion pointing outwards (as shown centre below) and refit the Valve housing with firm hand pressure only. 17 - SMITHS CONFIDENTIAL -

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4: Check the condition of the Exhalation Valve element Check the condition of the Exhalation Valve element Update the “Check Condition of Exhalation Valve Diaphragm” box

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5: Alarms and indicators Check function of alarms and indicators In this section the tests are made for the following check boxes in the Alarms section.

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5: Check function of alarms and indicators - Continued Check function of alarms and indicators - Continued i) Set the Function Selector to ‘0’. ii) Without a gas supply connected to the ventilator, select CMV + PEEP. iii) The gas supply indicators will stay red but the alarm LEDs will flash in sequence, starting bottom left and rotating in a clockwise direction. After all 6 LEDs have flashed a Medium Priority alarm will sound and continue for 1 minute. If the ventilator is still left switched on the alarm system will shut down. iv) Set the Function Selector to ‘0’

v) With the air and oxygen input hoses connected to the ventilator, connect the hose probes to appropriate gas supplies (minimum requirement 20L/min at 305kPa = approx. bar). vi) Connect a C0.5 R100 ISO Test Lung (500 - 84250) to the Patient Connection Port of the Patient Circuit. .

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