babyPAC B100 Ventilator Routine Service Manual Level 1 Issue 1p March 2006

CONTENTS

Contents

Page 1

SECTION ONE

Pages 3 - 4

Important General Information Safety information for Medical Gas cylinders

SECTION TWO

Pages 5 - 8

Service/Test Schedule babyPAC Service Report SECTION THREE

Pages 9 - 22

Checking Procedure SECTION FOUR

Pages 23 - 24

Spare Parts List Special Equipment and Tool List

© This procedure is the property of Smiths Medical International Ltd. Copyright for all purposes is vested in Smiths Medical. The reproduction of this procedure in whole or in part is prohibited without express consent in writing. This procedure is offered for use only with equipment manufactured or specifically recommended by Smiths Medical. Rights are reserved to make a charge for the use of this procedure or any part thereof and such right shall subsist unless and until the same shall be expressly waived in writing. Acceptance of this document will be construed as acceptance of these conditions. 504-2038 Iss. 1p 1 March 2006

INTENTIONALLY BLANK

504-2038 Iss. 1p

2

March 2006

IMPORTANT GENERAL INFORMATION

SECTION ONE

a) General The safety precautions given in this Section are to be seen as a guide only and are not intended to be a comprehensive list. i) Qualified persons Persons servicing and repairing Pneupac ventilators and regulators must be adequately trained and certified by the manufacturer for this task and must be fully conversant with the relevant contents of the User's Manual supplied with the equipment. Engineers must perform service repair and testing of equipment in line with both Health and Safety at Work regulations and their own employer’s procedures and observe the appropriate precautions necessary when handling pressurised gases. This Maintenance Procedure should be read fully before commencing servicing and testing. ii) Frequency of Checking Regular performance checking of the babyPAC ventilator must be carried out with equipment calibrated to ensure accuracy under the flow patterns generated by the ventilator. The user should determine the frequency of periodic checks dependent upon the intensity of use. Normally this would be not more often than once every 6 months but at least once every 2 years. iii) Oxygen Safety 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, cylinder, repair tools or repair surfaces used in the servicing of this equipment. Particular care should be taken to avoid any trace of contamination around the oxygen inlet and outlet ports of the ventilator. Oil or grease oxidise readily and in the presence of oxygen will burn violently. Regulator assemblies must not be immersed in liquid at any time. iv) Note to Service Engineers It is the responsibility of the customer to present the equipment in a fit condition for use and therefore servicing (if this is not your responsibility). This should enable you to quickly assess the condition of the equipment overall and any obvious damage. v) MRI When the ventilator is being used/or likely to be used in an MR Environment, it is important that only MR Compatible spares or accessories are used. This must be checked as part of the on- site maintenance procedure. vi) CE Marking The babyPAC 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. All such parts sold by Smiths Medical have /CE incorporated in their order code. Parts that are not marked with /CE are only for sale outside the countries bound by the Directive. 504-2038 Iss. 1p

3

March 2006

b) SAFETY INFORMATION FOR MEDICAL GAS CYLINDERS

1)

The warnings on the previous page relating to the use of oxygen are particularly relevant to gas cylinders and cylinder pressure regulators.

2) All personnel handling medical gas cylinders should have adequate knowledge of the properties of the gas, the precautions to be taken and the correct operation of the equipment. 3) Check the cylinder for the name of the gas and the colour code to ensure that the correct cylinder is being used. 4) Before using a cylinder check that it and its valve are in good condition. If there appears to be any damage do not use it. 5) All cylinders are fitted with a colour coded ring on the valve stem showing when it is due for inspection or test. Check that the cylinder is within date. If not do not use it. 6) Completely remove the disposable plastic seal from the valve. Open the valve momentarily to blow any contamination out of the valve outlet. Ensure that the outlet is not directed towards any person. 7) Ensure that the connecting faces on the cylinder and the regulator or fitting are clean and free from scoring or damage. 8) The regulator or fitting can now be attached, using only a reasonable amount of effort to tighten the connection. Never use a hammer or lever. 9) Always open the cylinder slowly. 10) Always close the cylinder valve fully before disconnecting the regulator assembly and fit a cap or tape to the cylinder valve outlet to keep it clean.

504-2038 Iss. 1p

4

March 2006

SECTION TWO TEST SCHEDULE FOR PERIODIC CHECKING OF babyPAC B100 VENTILATOR

(1)

Report details

(2)

Check the condition of the Regulator Assembly/Assemblies

(3)

Check the condition of the cylinder key

(4)

Replace the cylinder seal and check the Regulator Assembly Performance

(5)

Check the condition of the Input Hoses

(6)

Check the condition of the Patient Circuit

(7)

Check the condition of the babyPAC (including alarm functions)

(8)

Check the condition of Exhalation Valve element

(9)

Check function of the gas supply indicators

(10)

Carry out lock-off leak test at supply gas inlet connectors

(11)

Check the Function Selector switch

(12)

Check calibration of Inspiratory (TINS) and Expiratory (TEXP) controls

(13)

Check calibration of PEEP / CPAP Pressure control

(14)

Check calibration of Inspiratory Pressure control

(15)

Check calibration of Oxygen concentration control (oxygen only supply on CMV)

(16)

Check calibration of Oxygen concentration control (oxygen and air supply on CPAP)

(17)

Check calibration of Audible High Pressure Alarm control

(18)

Check the condition and security of mounting box, brackets, clamps and/or pole mounts

(19)

Attach Service Label

(20)

Report non-critical faults to customer

(21)

Report critical faults to customer (including ‘Warning Do Not Use’label if no exchange unit is available)

(22)

Obtain acceptance signature on Service Record Sheet where applicable

504-2038 Iss. 1p

5

March 2006

INTENTIONALLY BLANK

504-2038 Iss. 1p

6

March 2006

SERIAL NUMBER No

babyPAC B100 SERVICE RECORD SHEET OXYGEN REGULATOR SERIAL No.

AIR REGULATOR SERIAL No.

(1) QUALIFIED PERSON:-

SIGNATURE:-

(2) CHECK CONDITION OF REGULATOR ASSEMBLY

OK / FAIL - REASON:-

DATE :

(3) CHECK CONDITION OF CYLINDER KEY

OK / FAIL - REASON:-

(4) CHECK REGULATOR ASSEMBLY OUTPUT

OK / FAIL - REASON:-

CHECK CONDITION OF THE INPUT HOSES.

OK / FAIL - REASON:-

CHECK CONDITION OF THE PATIENT CIRCUIT.

OK / FAIL - REASON:-

CHECK CONDITION OF CONTROL MODULE.

OK / FAIL - REASON:-

CHECK CONDITION OF EXHALATION VALVE DIAPHRAGM

OK / FAIL - REASON:-

CHECK FUNCTION OF GAS SUPPLY INDICATORS AND ALARMS OXYGEN

OK / FAIL

AIR

OK / FAIL

CARRY OUT LOCK OFF LEAK TEST TO GAS INPUT SUPPLY (MAXIMUM 3 PSI IN 30 SECONDS)

OK / FAIL

AIR

OK / FAIL

OXYGEN

CHECK FUNCTION OF THE SELECTOR SWITCH Position

OFF

CMV+PEEP

CMV + ACTIVE

CPAP

IMV+CPAP

CHECK ALARM FUNCTIONS POWER SHUT DOWN

OK / FAIL

LOW PRESSURE DISCONNECT

OK / FAIL

SINGLE GAS OPERATION

OK / FAIL

LOW BATTERY

OK / FAIL

SUPPLY GAS FAILURE

OK / FAIL

HIGH PRESSURE

OK / FAIL

SINGLE GAS ACKNOWLEDGE

OK / FAIL

CONSTANT POSITIVE PRESSURE

OK / FAIL

CYCLE

OK / FAIL

CONSTANT POSITIVE PRESSURE ACKNOWLEDGE

OK / FAIL

CHECK CALIBRATION OF INSPIRATORY (TINS) AND EXPIRATORY (TEXP) CONTROLS SETTING

ON OXYGEN ONLY @ 100% CONCENTRATION PEEP=0, PEAK=30, VRV=80

ON AIR @ 21% CONCENTRATION PEEP=0, PEAK=30, VRV=80

Tins

Texp

CMV Tins TOL

0.25

0.25

0.34/0.17

0.35/0.17

3.50/1.675

0.33/0.15

0.33/0.15

3.33/1.50

0.75

0.75

0.90/0.65

0.90/0.65

9.00/6.525

0.85/0.60

0.85/0.60

8.48/6.00

2.00

4.00

2.40/1.74

4.80/3.48

48.00/34.80

2.26/1.60

4.52/3.20

45.20/32.00

CMV Tins ACT

CMV Texp TOL

CMV Texp ACT

IMV Texp TOL

IMV Texp ACT

CMV Tins TOL

CMV Tins ACT

CMV Texp TOL

CMV Texp ACT

IMV Texp TOL

IMV Texp ACT

CHECK CALIBRATION OF PRESSURE CONTROLS PEEP /CPAP ON OXYGEN (Tins & Texp=0.5, VRV=80, PEAK=70) CALIBRATION OF INSPIRATORY PRESSURE ON Max difference PEEP to CPAP 5 cmH2O, ACTIVE PEEP TO CPAP 2 cmH2O OXYGEN (Tins=2.0, VRV=80 , PEEP=0) O ONLY ACT O ACT O & ACT O & AIR SETTING TOL ACT TOL ACTIVE ACT ACTIVE TOL ACT SETTING TOL ACTMASTER ONLY AIR PAC GAUGE GAUGE PAC MASTER PEEP PEEP PEEP PEEP CPAP CPAP GAUGE GAUGE 2

MIN STOP 0

0

MAX 3

MAX 3

MIN STOP 12

17/7

DETENT 10

15/5

MAX 16

MAX 16

20

25/15

MAX STOP 20

25/15

MAX 26

MAX 26

DETENT 40

45/35

MAX STOP 70

80/60

2

2

2

OXYGEN CONCENTRATION CONTROL CALIBRATION CHECK ON 20 cmH2O BACKPRESSURE OXYGEN ONLY SUPPLY ON CMV SETTING

TOL

MIN STOP

OXYGEN & AIR SUPPLY ON CPAP ACT Tins 2.0 Texp 4.0

ACT Tins 0.25 Texp 0.25

SETTING

TOL

50/42

MIN STOP 21%

26/21

60%

65/55

MAX STOP 70%

75/67

80%

85/75

MAX STOP 100%

100/95

ACTUAL (20 cmH2O)

VARIABLE RELIEF VALVE PATIENT PRESSURE ALARM CALIBRATION CHECK SETTING

12

20

30

40

50

60

70

80

TOLERANCE

17/7

25/15

35/25

45/35

55/45

65/55

75/65

85/75

ACTUAL

MR8519 504-2038 Iss. 1p

7

March 2006

INTENTIONALLY BLANK

504-2038 Iss. 1p

8

March 2006

SECTION THREE PROCEDURE FOR PERIODIC CHECKING OF babyPAC B100 VENTILATOR

1.

Record Qualified Person’s details. Record the serial number of the babyPAC from the label on the rear of the control module and where applicable the serial number(s) of the regulator body(ies).

2.

Check the condition of the Regulator Assembly(ies) (refer to figure 1) i)

Check that the cylinder valve(s) is closed and the regulator assembly(ies) is depressurised. ii) Disconnect the equipment probes from the regulator assembly(ies). iii) Release the T-handle slowly and remove the regulator assembly from cylinder. iv) Check that the T-handle is straight, undamaged and screws in and out freely. v) Check that the T-handle retaining circlip is in position. vi) Check that the hexagonal nut on the pin-index yoke is tight. vii) Ensure that the gas indexing pins are in position and are secure. viii) From June 1997 a sintered filter has been fitted into the end of the pin-index yoke nipple. Check that this filter (where fitted) is clean and not blocked. (The filter may be replaced as described in Section 4 of the Maintenance Manual (504-2008) for High Pressure Regulator Assembly). ix) Check the gas specific outlet connector and assembly for slackness and tighten if loose. x) Check that the relevant probe fits correctly into the connector. xi) Check that the gauge is not loose and has not been bent in relation to the regulator. xii) Inspect the gauge for visible damage front and back. Ensure that the gauge indicator needle is positively against the zero position stop. xiii) Check that the gauge is fully protected by its rubber shroud and that the shroud is not damaged. xiv) Check that the two rubber blow-out discs in the over-pressure relief ports are in place in the regulator body. xv) Check that the secondary relief valve on the corner of the regulator block is not damaged or blocked. If damage is evident the regulator must be changed. xvi) If a Constant Flow Selector Head is fitted check the condition, looking for damage to the head and/or the outlet connector. xvii) Check that the head is securely fastened to the regulator manifold. xviii) Check that the Constant Flow Selector Head clickstop mechanism is effective. xix) Check that any movement between the pin-index yoke and the regulator assembly disappears when the assembly is attached to a cylinder.

3.

Check the condition of the cylinder key i) ii)

504-2038 Iss. 1p

Replace if cracking is apparent. Check that the attachment cable is not frayed or broken and is securely fixed to the handwheel

9

March 2006

Figure 1 2 (xv

2. (iii & (iv

3 (i & (ii 2 (xiii, (xiv & (xv

2 (ix, (x & (xi 2 (vii & (viii

Figure 2 Regulator Test Unit 500-A615

Figure 3 Regulator Test Unit 500-A615 in use on 500-A162 Regulator

504-2038 Iss. 1p

10

March 2006

4.

Replace Cylinder Seal and check the Regulator Assembly performance (refer to Figures 2 & 3) i) ii) iii) iv)

v)

vi)

vii) viii)

ix) x)

xi)

Fit a new seal (500-276) to the Regulator Assembly. Connect the pin-index yoke to a cylinder at least three quarters full. Connect the Test Unit to the outlet connector of the Regulator Assembly. Ensure that the Test Unit output is pointed away from the operator and that the flow/noflow switch is in the ‘Off’ (no-flow) position. Open the cylinder valve slowly allowing gas into the regulator and the Test Unit. With no flow the pressure gauge on the Test Unit will show the static output pressure of the regulator. Record this pressure which should be between 50 - 80 psi (345-552 kPa) (50-70 psi (345-483kPa) for CE regulator assemblies). Slide the flow/no-flow switch to the ‘On’ (flow) position. This allows gas to flow through the regulator and out of the Test Unit. The pressure gauge on the Test Unit now shows the dynamic output pressure of the regulator. Record the result and switch off the flow as soon as the reading is noted. This dynamic pressure will be lower than the previous static pressure but should be no less than 45 psi (310 kPa). Re-check the static pressure reading and in particular check that it does not creep continuously higher such that it eventually exceeds the upper allowed pressure of 80 psi (552 kPa) (70 psi (483 kPa) for CE regulators). If the pressure continues to creep upwards the main valve seat is leaking and the regulator needs corrective servicing. The above procedure should be repeated using a cylinder not more than a quarter full. Close the cylinder valve. The contents gauge should maintain a constant reading. If the pressure decays at a visible rate, a leak is occurring and corrective servicing is required. Vent the pressure by sliding the Test Unit switch to the ‘On’ position and then remove the Test Unit. Re-open the cylinder valve slowly, observe the contents gauge, then close the cylinder valve. The gauge should maintain a constant reading. If the pressure decays at a visible rate the outlet connector/s may be leaking and need corrective servicing. Where a Constant Flow Selector Head is fitted (500-A958) check the performance as follows: (a) Connect a calibrated flowmeter (e.g. 2-25 L/min; 500-82636) to the outlet connector of the Flow Head. (b) Using the table below check performance of the Flow Head across the range: Set Flow L/min 2 5 10 15

xii)

504-2038 Iss. 1p

Actual flow L/min 1.8 – 2.2 4.5 – 5.5 9.5 – 10.5 14.5 – 15.5

Replace the Regulator Assembly if any of the above checks fail or repair as detailed in the High Pressure Regulator Assembly On-Site Routine Service Procedure (504-2008).

11

March 2006

5.

Check the condition of the Input Hoses i) ii) iii) iv) v) vi)

6.

Check the condition of the Patient Circuit i) ii) iii) iv) v)

7.

From 1st January 2002 pressure hoses are date coded and should be replaced after 5 years. Check the label on hose for replacement date. Check the hose for damage, cuts and abrasions. Check that there is no internal damage to the hose by feeling the rigidity of the hose and looking for sloppiness. Ensure there is no delamination of the hose and no blisters or bubbles on the surface (check again when the hose is pressurised). Check union ends for signs of kinking and/or damage to hose or union. Replace hose if any of above is apparent.

Check the condition of the Patient Circuit for hardening, damage, splits or small holes in the hose wall. Check the connectors for excessive scoring and damage. If any defects are found, discard the Patient Circuit and replace with a new one. Check the Facemask (if fitted) for damage and splits. Check that the Facemask fits correctly to the 15mm female ‘Y' connector.

Check the condition of the babyPAC i)

ii) iii) iv) v)

vi)

vii) viii) ix) x) xi)

504-2038 Iss. 1p

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. Check that input and output connections are secure. Tighten if necessary Check that the input connector filters are clean. Check that the air intake filter is clean, unblocked and secure. Tighten if necessary. If any of the filters is dirty 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, Oring 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). 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. 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. Rotate each knob to its extreme limits to verify that the knob has not moved on its spindle. 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. The O2 concentration knob index mark should be equally spaced from each end of the yellow calibration scale. 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. (continued) 12

March 2006

7.

Check the condition of the babyPAC (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. 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 (500-82073) 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. 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. 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). 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.

504-2038 Iss. 1p

13

March 2006

8.

Check the condition of the Exhalation Valve element i)

ii) iii) iv) v) vi)

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). Ensure that the Valve base is tightly screwed into the manifold. 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. Ensure that the Valve Element is perfectly clean. It may be cleaned in warm soapy water but must be dried thoroughly before replacing. Inspect the seat edge within the Valve Housing for damage. Replace if damaged. Refit the Valve Element to its spigot with the centre pip pointing outwards (as shown centre below) and refit the Valve housing with firm hand pressure only.

Figures 4a, b & c High inflation pressure alarm

Inspiratory time TINS

Expiratory time TEXP

Function Selector switch

Connector Y-piece Supply gas failure visual alarm Oxygen concentration

PEEP/CPAP Inspiratory pressure

Figure 5 Controls and fittings of the babyPAC ventilator

504-2038 Iss. 1p

14

March 2006

Cycle Low inflation pressure (disconnect)

High inflation pressure/ Constant positive pressure

Low battery

Silence button Single gas operation/ Supply gas failure

Electronic alarm silenced/muted

Figure 6 Alarm Indicators

9.

Check function of alarms and indicators (refer to Figure 6) i) ii) iii)

iv) v) vi)

vii) viii)

504-2038 Iss. 1p

Set the Function Selector to ‘0’. Without a gas supply connected to the ventilator, select CMV + PEEP. 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. 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  bar). Connect a C0.5 R100 ISO Test Lung (500 - 84250) to the Patient Connection Port of the Patient Circuit. Turn on the air supply and the lower supply gas failure visual alarm should change from red to quartered white and black. Repeat for the oxygen supply; the upper alarm turning from red to white. Set both the Oxygen Concentration and the PEEP/CPAP controls to minimum. Select CMV + PEEP on the Function Selector switch. The ventilator should now begin to cycle and the alarm LEDs will go through the test sequence described in iii). The yellow ‘silenced’ LED (bottom right) should flash but no sound should be generated for 60 seconds. The ‘cycle’ LED should flash for 1/10 second each time the pressure rises through 10 x100Pa (10 cmH2O).

15

March 2006

9.

Check function of alarms and indicators (continued) ix)

Turn off the air supply. As the supply depletes, the air supply gas visual alarm should change to red. A medium priority electronic audible alarm giving a burst of three pulses 6 times a minute should then sound for 60 seconds to indicate a supply failure and the ‘single gas operation’ LED should illuminate in bursts of three flashes every 30 seconds. When the air supply is depleted the ventilator may pause but will then continue to operate on the oxygen supply. If the ventilator fails to change over it should be returned to the manufacturer for repair. x) Depress the Silence/Mute button and the electronic audible alarm should silence for 60 seconds. After this 60-second period has elapsed, depress the button again and the audible alarm will now remain muted, the second depression being interpreted as an acknowledgement by the operator that single gas operation has been recognised. The ‘single gas operation’ LED will continue to operate to indicate this mode. xi) Set the Oxygen Concentration control to its maximum (100%) position. xii) Turn off the oxygen supply. xiii) Repeat step ix) above but this time the oxygen supply gas failure visual alarm should change to red and the audible alarms should sound. After 60 seconds the alarm system should switch itself off in order to protect the battery if the ventilator is left in a potential alarm condition after use. xiv) Select ‘0’. xv) Turn on the oxygen supply only. xvi) Select CMV + PEEP. No audible alarm should sound as the condition of one gas supply only at start up is taken as an intended condition. The ‘single gas operation’ LED will, however, continue to flash as a reminder that this mode of operation has been selected. xvii) Select ‘0’. xviii) Remove the battery and insert a standard 1.5v AA size battery in its place. Select CMV+PEEP. The alarms should show as in viii) above but the low battery light should also flash. xix) Select ‘0’. Refit the original battery. Turn off the oxygen supply and disconnect from the supply connector.

10.

Carry out lock off leak test to input supply connections i) ii) iii) iv) v) vi)

vii) viii)

504-2038 Iss. 1p

Connect an isolation valve with a calibrated 0-700 kPa (0-100 psi) gauge to the oxygen supply. Connect the oxygen supply hose to the isolation valve. Check that the isolation valve is open. Turn on the gas supply and note the pressure indicated. Close the isolation valve and check that the pressure retained between valve and the ventilator does not drop by more than 20 kPa (3 psi) in 30 seconds. If the pressure drops faster check that there is no leakage at the connections on the isolation valve, supply hose and ventilator. Also check that there is no leakage of gas from the air hose probe indicating a cross leak. No external leak would indicate an internal leak and the ventilator should be returned to the manufacturer for repair. Disconnect the oxygen supply and open the isolation valve to purge the hose. Repeat the test above for the air supply connection.

16

March 2006

11.

Check the Function Selector switch (refer to figure 5) i) ii) iii) iv)

v) vi) vii)

Connect a ratePAC (510-A1541) to the Test Lung. Connect the oxygen probe of the ventilator directly to the oxygen supply. Turn on the oxygen supply. There should be no alarms. Select each function in turn and check the following: a)

0 - No output from the ventilator nor the alarms.

b)

CMV+PEEP or CMV+ACTIVE PEEP - Pulsed output, times controlled by TINS and TEXP controls and pressures controlled by Inspiratory Pressure and PEEP/CPAP controls. The ‘cycle’ LED should flash for 1/10 second each time the pressure rises through 10 x100Pa (10 cmH2O). The ‘single gas operation’ LED should flash to indicate single gas selection.

c)

CPAP - Constant flow output from ventilator, not cycled. Pressure controlled by PEEP/CPAP control. No electronic alarms function during CPAP.

d)

IMV+CPAP - Pulsed output as CMV, but CPAP during a longer TEXP time. No electronic alarms function during IMV + CPAP.

Check for positive switching, i.e. that there are no indeterminate mid-positions where the function is not clearly indicated by the marking on the panel label. Turn to ‘0’. The ventilator should stop functioning and all alarms should cease. Turn off the oxygen supply.

12.

Check calibration of Inspiratory (TINS) and Expiratory (TEXP) Time controls

12a.

On Oxygen Only (refer to Figure 7) i) ii) iii) iv) v) vi)

vii) viii) ix) x) xi)

504-2038 Iss. 1p

Set Oxygen Concentration control to 100% (maximum) Set PEEP/CPAP pressure control to minimum. Set Inspiratory Pressure control to 30 x100Pa (30 cmH2O). Set Pressure Alarm to 80 x100Pa (80 cmH2O) maximum. Turn on oxygen supply. Select CMV + PEEP. The ‘single gas operation’ LED should flash every 30 seconds and the ‘cycle’ LED should flash for 1/10 second each time the pressure rises through 10 x100Pa (10 cmH2O). Confirm inspiratory pressure on the Patient Pressure Manometer. Select each of the settings specified on section 12a of the Service Record Sheet. Record the actual time for each TINS and TEXP setting in the appropriate boxes. Select IMV + CPAP and record the TEXP time in the appropriate box. (The electronic alarm system does not operate during the IMV mode.) Select ‘0’.

17

March 2006

Figure 7 12b.

On Oxygen and Air (refer to Figure 7) i) ii) iii) iv) v) vi) vii) viii) ix)

With oxygen still connected, reconnect the air supply. Set the Oxygen Concentration control to 21% (minimum). Turn on the air supply. The ‘single gas operation’ LED should not flash. Select CMV + PEEP. After the initial 60 seconds only the ‘cycle’ LED should be flashing. Select each of the settings specified on section 12b of Service Record Sheet. Repeat 12a vii), viii) and ix) above. Select ‘0’. All alarms should cease. Turn off and disconnect the air supply. Disconnect the ratePAC.

Figure 8 504-2038 Iss. 1p

18

March 2006

13.

Check calibration of PEEP & CPAP Pressure control (refer to Figure 8) i) ii) iii)

iv)

v)

vi) vii) viii) ix) x) xi)

14.

Connect a calibrated 0-100 x100Pa (0-100 cmH2O) pressure gauge (e.g. 500-82802/2) to the Test Lung. Set TINS and TEXP at 0.5 secs, Pressure Alarm at 80 x100Pa (80 cmH2O), Inspiratory Pressure at 70 x100Pa (70 cmH2O) and Oxygen Concentration to 100%. Select CMV+PEEP. The ‘single gas operation’ LED should flash every 30 seconds and the ‘cycle’ LED should flash for 1/10 second each time the pressure rises through 10 x100Pa (10 cmH2O). Check & record minimum, detent & maximum PEEP on both the calibrated gauge and the Patient Pressure Manometer. When the PEEP level is greater than 10 x100kPa (10 cmH2O) for longer than 8 seconds, the ‘cycle’ LED will not indicate but after 8 seconds the Constant Positive Inflation Pressure alarm should activate (see Figure 5). The ‘high inflation pressure’ LED should flash 2 times per second and a high priority audible alarm should sound, consisting of two bursts of five pulses at a rate of 6 times per minute. Depress the ‘silence’ button and the electronic audible alarm should silence for 60 seconds. After this 60-second period has elapsed, depress the button again and the audible alarm should now remain muted. The ‘single gas operation’ LED will continue to indicate. Select CMV+ACTIVE PEEP. Check & record minimum, detent & maximum ACTIVE PEEP on both calibrated gauge and Patient Pressure Manometer. Select CPAP. During CPAP no alarm should operate. Check & record minimum, detent and maximum CPAP on both the calibrated gauge and the Patient Pressure Manometer. The difference between the calibrated gauge and the Patient Pressure Manometer should be no more than 2 x100Pa (2 cmH2O). Select ‘0’.

Check calibration of Inspiratory Pressure control (refer to Figure 8) i) ii) iii) iv) v)

vi) vii) viii) ix) x) xi) xii) xiii) xiv) xv) xvi) 504-2038 Iss. 1p

Select CMV+ PEEP. The ‘single gas operation’ LED should flash and the ‘cycle’ LED should flash each cycle. Set TINS at 2.0 seconds. Set Pressure Alarm at 80 x100Pa (80 cmH2O). Set PEEP/CPAP control to minimum. Set the Inspiratory Pressure successively to minimum, 20 x100Pa (20 cmH2O), detent and maximum inspiratory pressures and record the readings on both the calibrated gauge and the Patient Pressure Manometer at each setting. Select ‘0’. Reconnect the air supply to the ventilator. Turn on the air supply. Set Oxygen Concentration to 21% Select CMV + PEEP. The ‘cycle’ LED should flash. Repeat v) above. Disconnect one limb of the Patient Circuit. After 8 seconds the ‘low inflation pressure’ alarm should flash and sound. The LED should flash 30 times a minute and the medium priority audible alarm should sound. Select ‘0’. Turn off and disconnect the air supply. Disconnect Patient Circuit, Test Lung and pressure gauge from the ventilator. 19

March 2006