VR1, VR1 Responder & VR1 Airmix Service Manual Issue 4 Jan 2007

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Table of Contents SECTION 1: WARNINGS & SAFETY PROCEDURES ... 6 1. 1. General ... 6

1. 1. 1. 1. 1. 2. 1. 1. 3.

Qualified persons ... 6 Frequency of checking... 6 Note to Service Engineers ... 6

1. 2. Warnings... 6

1. 2. 1.

Cautions ... 7

1. 3. SAFETY INFORMATION FOR MEDICAL GAS CYLINDERS ... 7

SECTION 2: PERIODIC CHECKING AND REPAIR PROCEDURES ... 10 2. 1. Introduction ... 10 2. 2. General ... 10 2. 3. Functional checks ... 10 2. 4. Performance check... 10 2. 5. Final Test... 10 2. 6. Customer Authorisation ... 10

SECTION 3: Performance Checking and Maintenance Procedures... 14 3. 1. General ... 14 3. 2. Tracking ... 14 3. 3. Visual Checks ... 14

3. 3. 1. 3. 3. 2. 3. 3. 3.

Check the condition of the Unit... 14 Check the Condition of the Input Hose ... 14 Check the Condition of the Patient Valve ... 15

3. 4. Performance Checks ... 15

3. 4. 1. 3. 4. 2. 3. 4. 3. 3. 4. 4. 3. 4. 5. 3. 4. 6. 3. 4. 7. 3. 4. 8.

Equipment required for performance checks... 15 Relief Valve Check... 15 Frequency and tidal volume checks... 16 Backpressure leak test ... 17 Demand inhibit function and Spontaneous breathing check ... 17 Carry out lock off leak test (60psi pressure)... 18 Demand Inhibit Function Fault Diagnosis... 19 Spontaneous Breathing Function Fault Diagnosis... 19

3. 5. Inlet filter replacement ... 20

SECTION 4: SPARE PARTS ... 26 SECTION 5: SPECIAL EQUIPMENT ... 30

© This procedure is the property of Smiths Medical International Ltd. Copyright for all purposes is vested in Smiths Medical International Ltd. 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 International Ltd. 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.

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SECTION 1 WARNINGS & SAFETY PROCEDURES

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SECTION 1: WARNINGS & SAFETY PROCEDURES 1. 1. 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. 1. 1. 1.

Qualified persons

Persons servicing and repairing Smiths Medical International Ltd. 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 and Service 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. 1. 1. 2.

Frequency of checking

Regular performance checking of the Pneupac VR1 ventilator must be carried out with recommended equipment. The user should determine the frequency of periodic checks dependent upon the intensity of use. Normally this would not be more often than 6 months but at least every 2 years 1. 1. 3.

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. 1. 2. Warnings Warnings are given to make you aware of dangerous conditions, that could lead to death or serious injury to the user or patient that can occur if you do not obey all of the instructions given in this manual. 1. Warnings and cautions Special attention must be paid to warnings and cautions which are summarised below. Failure to observe the warnings and cautions detailed in this Service Manual could compromise patient/user safety. 2. Use of Oxygen To avoid the risk of ignition, avoid smoking or naked flames. Do not use oil, grease or combustible lubricants (except those specifically approved for oxygen use) in contact with any part of the device, regulator or cylinder. To avoid ignition by adiabatic expansion, connect the device to the regulator before opening the cylinder valve slowly.

Warning: Regulator assemblies must not be immersed in liquid at any time. 3. Potential unacceptable performance There is a risk of unacceptable performance when alternative ventilator patient circuits or accessories are used. Failure to use patient circuits and accessories recommended in this User’s Manual may lead to unacceptable device performance. 4. Provision of spares There is a risk of unsatisfactory performance if this device is serviced by a third party other than one recommended by the manufacturer. Failure to use the manufacturers’ recommended service provider or spares may lead to unsatisfactory device performance.

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5. Dry input gas To avoid harm to the patient due to erratic performance of the VR1 in extreme environments, only dry oxygen should be used with this device.

1. 2. 1.

Cautions

Cautions warn of dangerous conditions that can occur and cause damage to the device or its accessories. 1. Caution: Silicone components DO NOT use solvents to clean any of the silicone components, particularly the patient valve components, as this may result in silicone becoming adhesive and consequently creating an obstruction in the gas path. 2. Caution: Sterilisation of the VR1 Do not attempt to sterilise the VR1 or to clean it by immersion in any fluid.

1. 3. SAFETY INFORMATION FOR MEDICAL GAS CYLINDERS i) The warnings on the previous page relating to the use of oxygen are particularly relevant to gas cylinders and cylinder pressure regulators. ii) All personnel handling medical gas cylinders should have adequate knowledge of the properties of the gas, precautions to be taken and the correct operation of the equipment. iii) Identify the correct cylinder required by means of the name of the gas and the colour coding to ensure that the correct cylinder is being used. iv) Before using a cylinder check that both the cylinder and its valve are in good condition. If there is any damage apparent do not use the cylinder. v) In the UK 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 the cylinder. vi) 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. vii) Ensure that the connecting faces on the cylinder and the regulator or fitting are clean and free from scoring or damage. viii) The regulator or fitting can now be attached, using only a reasonable amount of effort to tighten the connection. Never over tighten the connection using a hammer or lever. ix) Always open the cylinder slowly. x) Always close the cylinder fully before disconnecting a cylinder and refit the protective cap or tape to the cylinder valve outlet to keep it clean. 3. Caution: Prevention of gas loss To ensure that the cylinder contents are not lost during storage due to small leaks or unintentional operation, it is recommended that the valve on the gas cylinder is turned off after use.

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SECTION 2 SERVICE SCHEDULE

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SECTION 2: PERIODIC CHECKING AND REPAIR PROCEDURES 2. 1. Introduction The Pneupac VR1 is enclosed in a tamper-evident enclosure and is serviced as described below. Intervention inside the device is only possible by returning the device to a Smiths Medical International Ltd. service centre. The service engineer must have a Pneupac VR1 User’s Manual (Pt. No. 504-2105) at hand. Smiths Medical International Ltd. recommends service is conducted by a Smiths trained and certificated engineer as described below at intervals of between six months and two years depending upon usage. Users should return faulty or damaged product to Smiths Medical service centres for repair and calibration. During the warranty period, users should contact Smiths Medical regarding faults. An extended warranty and maintenance service contracts are available from Smiths Medical. 2. 2. General 1. 2. 3. 4.

Record device part number and serial number details in Service log Check the general condition of the unit. Check the condition of the Input Gas Hose. Check the condition of the Patient Valve.

2. 3. Functional checks Refer to section 3.2.2 of the User’s Manual (504-2105) for details of this procedure.

2. 4. Performance check Conduct performance checks as per Section 3 to confirm device is performing to specification. The following performance checks will be carried out.

1. 2. 3. 4. 5.

relief valve pressure check, frequency and tidal volume checks, patient circuit leak test, lock off leak test, demand inhibit and spontaneous breathing check

2. 5. Final Test 1. Reinstate to original set-up. 2. Affix Service Labels (if required). 2. 6. Customer Authorisation Obtain a customer authorisation signature on the Service Record Sheet where applicable.

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SECTION 3 PERFORMANCE CHECKING And MAINTENANCE PROCEDURES

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SECTION 3: Performance Checking and Maintenance Procedures 3. 1. General Performance checks are conducted on a routine basis to establish that the device is still functioning as it was intended to, in addition to it’s physical integrity. Some of the functions that can be confirmed to be within specification are as follows: tidal volume and frequency. If the performance checks indicate that the device is within specification then carry out a full functional check as detailed in section 3.2.2 of the User’s Manual (504-2105) If the device does not meet the required specification at any stage of the performance check, the device paperwork should be marked with a short description of the failure and arrangements made to return the device to a Smiths Medical International Ltd. Service Centre in accordance with local procedures. 3. 2. Tracking To ensure traceability of the faulty devices, record the serial number and the model type on the VR1 Service Test Result Sheet. 3. 3. Visual Checks Prior to any extensive test using special test equipment, carry out the following visual checks. 3. 3. 1.

Check the condition of the Unit

1. Check the ventilator, looking for signs of damage to the input and output fittings, the controls, markings and the relief valve for evidence of blockage. 2. Check the the inlet regulator filter and replace as detailed in section 3.5 if necessary. 3. Check for signs of damage to the case and ensure lid is secured to the base. 4. Check that the rotary control moves smoothly, is not loose and does not foul against the lid and base. 5. Move the rotary control to its extreme limits. Check to see if the calibration line travels beyond the markings on the lid to verify that the control has not moved on the spindle. 6. Check that the manual push button and lever and mode selector dial move smoothly. 7. Check the Airmix switch (if fitted) for free movement and that it will toggle to 50% and 100% positions. 8. Replace any damaged labels or return the device to the manufacturer / distributor in accordance with local procedures, where markings are significantly damaged. 9. If soiled or damaged, pull off and replace extension lever ‘bulb’ 520-1066. 3. 3. 2. Check the Condition of the Input Hose Gas input hoses are date coded and should be replaced after five years. Check the label on hose for replacement date. 1. Check the hose for damage, cuts and abrasions. 2. Check that there is no internal damage to the hose by feeling the rigidity of the hose and looking for sloppiness. 3. Ensure there is no delamination of the hose and no blisters or bubbles on the surface (check again when the hose is pressurised). 4. Check union ends for signs of kinking and/or damage to hose or union. 5. Replace hose if any of above is / are apparent (refer to the table on page 26 for appropriate part no.). 14

3. 3. 3.

Check the Condition of the Patient Valve

1. Check the Patient Valve assembly for cracks, splits and scoring to the connection faces. 2. Disassemble the Patient Valve by unscrewing the lower housing from the VR1 and carefully remove the valve element (lip valve).

W195-122 Lip Valve

W195-008 Flutter Valve

3. Inspect the element by gently stretching, looking for splits or tears. Replace if necessary. 4. Carefully remove the flutter valve. 5. Inspect the element as detailed in steps 2. And 3 above. Replace if necessary. 6. If replacement is not necessary, thoroughly wash the components in warm water and mild detergent. Caution: DO NOT use solvents to clean any of the silicone components, particularly the patient valve components, as this may result in silicone becoming adhesive and consequently creating an obstruction in the gas path.

520-1088 Lower Housing The three component parts above, combine to form the patient valve assembly, part number 520A1088

520A1088 Patient Valve Assembly

7. Afterwards rinse all components thoroughly with water to eliminate all residues of the detergents used. Sterilise the components using one of the following methods; -

ETO gas sterilisation

-

Autoclaving up to 134°C

Patient valve assembly

8. After cleaning and sterilisation, thoroughly dry all components. 9. Reassemble the Patient Valve ensuring that the valve element is inserted the correct way round and that the flutter valve is correctly seated and is not distorted when the lower housing is reattached. 10. Carry out the functional check described in section 3.2.2 of the User’s Manual (504-2105). 3. 4. Performance Checks 3. 4. 1. Equipment required for performance checks The following equipment will be required to carry out the performance checks. Details of the equipment is in section 5. TSI Certifier FA Test System, Digital flowmeter with high flow module including TSI filter Back pressure device Pipeline Isolation Switch (Isolation valve) Test hose (Green) Heat & Moisture Exchange Filter Oxygen supply When using the TSI, the following must be observed:

• • •

must use filter a stationary and consistent method of orientating the TSI high flow certifier module should be used for consistency during performance checks, connected to the ventilator by the test hose the driving gas temperature should be within 10ºC of the ambient temperature for the TSI to be accurate and the TSI should not be used below 0ºC.

3. 4. 2. Relief Valve Check The relief valve performance can be checked as follows: 1. Ensure that input hose is connected to both the VR1 and an adequate oxygen supply. 2. Attach a backpressure device to the patient valve on the VR1 15

3. Set the ventilator to the AUTO position and turn the oxygen supply on.

4. Move the rotary control to the CHILD*C position and fully close the backpressure device. 5. Record result on VR1 Service Test Result Sheet 6. Open backpressure device, move the selector to to ADULT*A position and allow the ventilator to cycle through 4-5 breaths. 7. Fully close backpressure device. 8. Record the gauge indication on VR1 Service Test Result Sheet. 9. Open backpressure device. 10. On both selections, relief valve must operate between 30 to 48 cmH2O. 3. 4. 3. Frequency and tidal volume checks a. 100% O2 (No Airmix)- where Airmix switch fitted 1. Attach green hose (W7401) to backpressure device. 2. Connect TSI unit to the other end of green hose using the HME filter as shown in the figure overleaf. 3. Set the TSI unit to Oxygen gas supply* 4. Set for BPM and tidal volume on STP setting* 5. Move the rotary control to the ADULT*A position and allow the ventilator to cycle through 4-5 breaths for the Certifier to integrate the readings. 6. Check BPM & Tidal volume readings on the Certifier and record results on VR1 Service Test Result Sheet 7. Move the rotary control carefully to the DETENT position and allow the ventilator to cycle through 4-5 breaths 8. Check BPM & Tidal volume readings on the Certifier and record results on VR1 Service Test Result Sheet 9. Move the rotary control to the CHILD*C position 10. Check BPM & Tidal volume readings on the Certifier and record results on VR1 Service Test Result Sheet 11. Return the rotary control to the DETENT position. 12. Check BPM & Tidal volume readings on the Certifier and record results on sheet 13. The maximum difference between the two readings for DETENT position must not exceed 0.5 BPM. *

Refer to the TSI Certifier FA Test System Operator’s Manual (1980436). An electronic copy is located at the following website: http://www.tsi.com/documents/1980436e.pdf.

*C For CHILD set the rotary control as illustrated (triangular marker is aligned with 150/25, not the end of travel).

*A For ADULT set the rotary control as illustrated (triangular marker is aligned with 1050/10, not the end of travel). 16

Back-pressure gauge

Oxygen Monitor

Filter

VR1 Resuscitator

Variable Back-pressure Device

3.4.3. b.

TSI Certifer

Frequency and tidal volume (cont’d) For 50% O2 (Airmix) - where Airmix switch fitted

1. With the green hose and backpressure device still attached, set the backpressure device to 15 cmH2O with the rotary control set to ADULT. DO NOT adjust the backpressure device setting for the remainder of this test. 2. Connect an Oxygen Monitor (W7038) to the outlet port of the TSI certifier. The Oxygen Monitor should be calibrated with 100% oxygen at least once every 8 hours. 3. Steps 2 to 13 are the same as detailed in paragraph 3.4.3a above but check and note the oxygen concentration at each setting, which should be between 45% and 55%. 3. 4. 4.

Backpressure leak test

1. Ensure the backpressure device is connected (3.4.2 #2) and the rotary control set to CHILD. 2. Ensure TSI unit is prepared as detailed in 3.4.3 #2 to #4 3. Close the backpressure device to give an indication of 5cmH2O on the gauge. 4. Record the tidal volume from the Certifier on the VR1 Service Test Result Sheet. 5. Close the backpressure device to give an indication of 25cmH2O on the gauge. 6. Record the tidal volume from the Certifier on VR1 Service Test Result Sheet. 7. Max. difference between the tidal volume two readings is 10mL. 8. Turn off the TSI and remove all the test equipment. 3. 4. 5. a)

Demand inhibit function and Spontaneous breathing check (not applicable to VR1 Responder) Demand inhibit function check

1. Connect a test mask to the patient valve using a Breathing or Heat & Moisture Exchange Filter to provide a contamination barrier. 2. Ensure the rotary control is set to the DETENT position. 3. After giving the ventilator time to stabilise, draw three to four typical adult breaths starting in the expiratory phase and observe that the ventilator inhibits automatic cycling. 4. Stop demanding breaths from the ventilator and it should revert to automatic cycling after the correct expiratory time has elapsed. 5. Repeat using short ‘panting’ breaths. The ventilator should ignore these and continue automatic cycling.

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b) Spontaneous breathing check When gas supply falls below the minimum input pressure 40 psi, the Spontaneous Breathing Valve opens to atmosphere before the oscillator stops, to prevent an excessive inspiratory period. To test this function, proceed as detailed below. 1. Close the cylinder or supply and continue to demand breaths. The breathing resistance will increase. When the supply is depleted the internal spontaneous breathing valve should open. There should be a slight increase in breathing resistance as air is drawn through the spontaneous breathing valve from atmosphere 2. Remove the test hose, mask and filter (if fitted). If the filter was not used, ensure that the patient 3. valve is cleaned as detailed in section 3.3.3 above. 3. 4. 6.

Carry out lock off leak test (60psi pressure)

1. Disconnect the input hose from the oxygen cylinder or gas supply and fit an isolation valve and pressure gauge to the input hose. 2. Re-connect to the gas supply. 3. Ensure unit is in Manual position. 4. Open the isolation valve to charge the ventilator. Allow time for the ventilator internal pressure to stabilise then note the pressure 5. Switch the Lock off toggle to the open position, pressure will rise on inlet pressure gauge to 60psi. 6. Close the isolation valve and observe the inlet pressure gauge for 1 minute. The pressure should not drop by more than 2 psi, record results on test result sheet. If the leak is greater than than 2 psi in 1 minute, there is an internal leak which needs rectification.

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3. 4. 7.

Demand Inhibit Function Fault Diagnosis Allow time to stabilise

Set to AUTO & DETENT position

Demand 3 to 4 ADULT breaths starting in the expiratory part of the cycle.

Ventilator delays before next cycle ?

Retry with a larger breath than previously during the expiratory phase.

NO

YES

Stop demanding breaths ventilator should restart.

Does the ventilator restart ?

Ventilator ‘inhibits’ i.e. no ventilator cycling whilst demanding breaths .

YES

Renew gas supply

NO

Ensure adequate gas supply

NO

Does Ventilator ignore these breaths and continue cycling ?

YES Allow ventilator to cycle two-three times

Take several short ‘panting’ breaths.

Ventilator delays before next cycle ?

NO

Is the supply ok ?

YES

NO

Device faulty, Refer to Manufacturer

YES Demand working.

3. 4. 8.

Spontaneous Breathing Function Fault Diagnosis Allow time to stabilise

Set to AUTO & DETENT position

Demand 3 to 4 ADULT breath from the ventilator Close gas supply Demand breath(s) until gas supply is exhausted

NO

Continue demand breaths

Is there any external gas supply to ventilator ?

Can you breath through the Device ?

NO

YES

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YES

Device faulty, Refer to Manufacturer

Spontaneous Breating Function working