Vitalograph

alpha Model 6000 Service Manual Issue 1

Service Manual

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Vitalograph ALPHA Service Manual 07371 Issue 1

Alpha MODEL 6000

Service Manual

l Copyright Vitalograph 2007

Vitalograph ALPHA Service Manual 07371 Issue 1

Vitalograph Ltd., Maids Moreton, Buckingham, MK18 1SW, England Phone: (01280) 827110 Fax: (01280) 823302 e-mail: [email protected] Vitalograph GmbH, Jacobsenweg 12, 22525 Hamburg, Germany Phone: (040) 54 73 91-0 Fax: (040) 547 391 40 e-mail: [email protected] Vitalograph Inc., 13310 West 99th Street, Lenexa, Kansas 66215, U.S.A. Phone: (913) 888-4221 Fax: (913) 888-4259 e-mail: [email protected] Vitalograph (Irl.) Ltd., Gort Road Business Park, Ennis, Co. Clare, Ireland Phone: (065) 6864100 Fax: (065) 6829289 e-mail: [email protected] Internet: www.vitalograph.com

 Copyright Vitalograph 2007 Current Edition (Issue 1) Cat. No. 07371 Vitalograph is a registered trademark.

Vitalograph ALPHA Service Manual 07371 Issue 1

TABLE OF CONTENTS DECLARATION OF CONFORMITY ... 3 INTRODUCTION ... 4 PRINCIPLES OF OPERATION ... 4 START UP OF THE INSTRUMENT... 5 HYGIENE ... 5 General Recommendation... 5 Routine Practice ... 5 Table of Materials Used & Cleaning/Disinfection Methods ... 6 Disassembling the Flowhead for Cleaning and Disinfecting...7 Reassembling the Fleisch Flowhead... 8 INSTRUCTIONS FOR USE ... 8 CHECKING ACCURACY... 8 FUNCTIONAL CHECK ... 9 SOFTWARE CHECK ... 9 FAULT FINDING GUIDE ... 9 INSTRUMENT ACCESSIBILITY ... 11 Internal Testing ... 13 PowerSAFE Supply Voltage ... 13 Internal Power Supplies ... 13 Battery for RTC ... 14 Fuse ... 14 REPLACING PARTS ... 14 LCD Screen (65042) & LCD PCB (65043) ... 14 Keypad PCB (65044)... 14 Printer (67054) ... 14 Main PCB Service Exchange – 65045 ... 15 Power Inlet Socket - 311209... 15 On/Off Switch – 311338... 16 ROUTINE ANNUAL SERVICE ... 16 Training & Qualifications Required To Perform Service Procedure ... 16 SERVICE TOOLS ... 17 Special Tools Required... 17 PPM Service Kit ... 17 Service Procedure ... 17 PLANNED PREVENTIVE MAINTENANCE SERVICE... 18 CONSUMABLES AND ACCESSORIES ... 19 TECHNICAL SPECIFICATIONS ... 19 APPENDIX A: CIRCUIT DIAGRAM ... 20 APPENDIX B: FUNCTIONAL BLOCK DIAGRAM... 27 APPENDIX C: SAMPLE RISK ASSESSMENT... 28 APPENDIX D: VOLTAGE TEST POINTS ... 30

Vitalograph ALPHA Service Manual 07371 Issue 1

DECLARATION OF CONFORMITY Product:

Vitalograph

alpha

Vitalograph hereby ensures and declares that the above product associated with this user manual, is designed and manufactured in accordance with the following QMS regulations and standards: •

European Medical Devices Directive {MDD} 93/42/EEC. This device, classified as 2a as per Annex IX of MDD 93/42/EEC, meets the following provisions of Annex II of the Medical Devices Directive as per Article 11, section 3a, excluding point 4 of Annex II.

•

Canadian Medical Device Regulation {CMDR}

•

FDA Quality System Regulation {QSR} 21 CFR 820.

•

EN ISO 13485: 2003. Medical devices. Quality management systems. Requirements for regulatory purposes.



Certifying Body {for 93/42/EEC and CMDR}: British Standards Institute {BSI} Certificate Nos. CE 00772, MD 82182, FM 83550 Signed on behalf of Vitalograph (Ireland) Ltd.

B. R. Garbe. Group Managing Director This Manual is intended for use only by suitably qualified medical device technicians, who have been trained on the procedures in this manual.

Vitalograph ALPHA Service Manual 07371 Issue 1

INTRODUCTION The Vitalograph ALPHA is a desktop spirometer designed for use by trained professionals in the doctor’s office, clinic, hospital department, etc. for measuring and archiving tests on human subjects. Demographic data are uploaded or entered via a keypad and stored, together with spirometry test data. Current test data can be viewed on the LCD and printed and downloaded to a PC. There are a variety of backup and other configuration options. NOTE: THERE ARE NO INTERNAL USER ACCESSIBLE PARTS IN THIS DEVICE. THE DEVICE CASING SHOULD NOT BE OPENED UNDER ANY CIRCUMSTANCES EXCEPT BY A QUALIFIED TECHNICIAN TRAINED ON THIS DEVICE. FAILURE TO OBSERVE THIS WILL INVALIDATE THE WARRANTY. FOR FURTHER INFORMATION OR ADVICE, PLEASE CONTACT VITALOGRAPH.

PRINCIPLES OF OPERATION Instantaneous expired and inspired respiratory air is detected with a fleisch pneumotachograph type of flowhead (1). Inside the flowhead the bundle of capillary tubes creates a very slight resistance. This series of small parallel tubes create a pattern of laminar flow in the air passing through. The differential pressure is directly proportional to air flow rate with an extremely wide turndown ratio, which is measured by a pressure transducer (2) inside the Vitalograph ALPHA. The output from the pressure sensor is passed through an A/D converter. The digital signals from the A/D are monitored and analysed by the Vitalograph ALPHA firmware. 1. Flowhead 2. Pressure Transducer

Figure 1. Operating Principle

Vitalograph ALPHA Service Manual 07371 Issue 1

START UP OF THE INSTRUMENT The flowhead is attached to the Vitalograph ALPHA by dual silicone tubing (flowhead connection tube). Ensure that the coloured/ribbed tapping on the flowhead is connected to the ribbed/coloured side of the connection in the housing. Open the printer door and feed the paper through the printer. The Vitalograph ALPHA can be used with the purpose-built low voltage PowerSAFE unit with which it is supplied or the internal Battery Pack. Attempted use with other power sources may cause irreparable damage and invalidate the warranty. The output from the PowerSAFE is 12 volts DC. The jackplug from the PowerSAFE connects into the socket on the rear of the Vitalograph ALPHA. Plug the mains plug into a suitable socket, operate the On/Off switch on the rear of the instrument and the Vitalograph ALPHA is ready for use.

HYGIENE General Recommendation To reduce the risk of cross infection between test subjects, only the BVF™ or a SafeTway® mouthpiece are validated by the manufacturer for use with this device. A Risk Assessment should be carried out by the user to assess the risks presented to both operator and subject in his facility, and an action plan devised by the facility to minimise the chance of cross infection occurring, particularly where known infectious or immuno-deficient subjects are being tested (See Appendix C). An assessment should be made of the facility’s available methods of decontamination and their effectiveness against potential risks - a table of materials used in the Vitalograph ALPHA is provided in the following page to assist in this. It is recommended in cases of high risk, where no effective disinfection methods are available, that the contaminated parts are disposed. For this device, this will normally be the flowhead and the flowhead connection tube only.

Routine Practice A new mouthpiece (either SafeTway® or BVF™) should be used for each subject. A delay of at least 5 minutes should be allowed between subjects to allow settling of previously aerosolized particles in the measuring device. It is recommended that the flowhead be regularly cleaned according to the guidelines of the user’s facility.

Vitalograph ALPHA Service Manual 07371 Issue 1

In the event of visible contamination of the flowhead cones or flowhead element these should be cleaned or disinfected as in the table below. The flowhead conditioning meshes should also be replaced in the event of damage, or if visibly contaminated. The frequency of this is dependent on the Facility’s Risk Assessment, usage and test environment, but should be at least monthly or every 100 subjects (500 blows). It is recommended that the flowhead-flowhead complete and flowhead connection tube-be replaced annually. Refer to Figure 2 for identification of parts.

Table of Materials Used & Cleaning/Disinfection Methods This listing of materials used is given to provide users with information to allow the assessment of other cleaning and disinfecting procedures available in the facility on this device.

Part

Material

Clean/ Disinfect

Autoclave Recommended Disinfectants

Top Case Exterior Bottom Case Exterior White Flowhead Tube

Painted, ABS

Clean

Painted, Aluminium Silicone Rubber

Clean

Viable

Screen

Electrode with Anti-NewtonRing Treatment

Clean

Aluminium, Stainless Steel Aluminium & Acetyl TPX

Clean

Viable

Clean & Disinfect Clean & Disinfect Clean & Disinfect Dispose

Fleisch Element Flowhead Body Flowhead Cone Flowhead End Cap Flow Conditioning Meshes

TPX Acetyl and Polyester

Viable Viable

Wiping with a 70% isopropyl alcohol impregnated cloth provides a suitable form of cleaning and lowlevel disinfection. This may be preceded by cleaning with an anti-static foam cleaner if necessary. NOTE: Ensure isopropyl alcohol does not come in contact with the touchscreen. Warning: Paper tear bar contains sharp edges. Users should take care not to cut/scrap their fingers. Lightly wipe the surface with cotton pad or other soft material. NOTE: DO NOT use chemicals such as acetone, toluene, ethanol or isopropyl alcohol. DO NOT wipe in a circular motion. Strokes should be either up/down or over/back. Disinfect by immersion in sodium dichloroisocyanurate solution at 1000 ppm concentration of free chlorine for 15 minutes (see following section for recommended cleaning/disinfection method for the Vitalograph ALPHA Flowhead) The flowhead may also be disinfected by autoclaving at 134°C for 3 minutes or 120°C for 20 minutes.

All external parts of the Vitalograph ALPHA require cleaning, i.e. the removal of visible particulate contamination. The parts of the Vitalograph ALPHA that make up the flowhead, which comes into contact with subjects being tested, also require disinfecting. A spirometer is not designed as a ‘sterile’ device. Definitions of cleaning and disinfection are as defined in “Sterilization, Disinfection and Cleaning of Medical Equipment: Guidance on Decontamination from the

Vitalograph ALPHA Service Manual 07371 Issue 1

Microbiology Committee to Department of Health Medical Devices Directorate, 1996”. Recommendations for chemical disinfectants are derived from the PHLS publication “Chemical Disinfection In Hospitals 1993”. Disassembling the Flowhead for Cleaning and Disinfecting 1. Remove the cone and the end cap from the flowhead. 2. Remove the flow conditioning meshes from inside the cone and the end cap, and discard them. 3. To remove the flowhead body from the fleisch element, place the fleisch element on a hard, flat surface with the largest diameter at the top. Push down on the flowhead body with thumbs and forefingers until it reaches the flat surface. A final pulling and twisting action will separate the parts. Figure 2 shows the various parts that make up the Flowhead. 1. 2. 3. 4. 5. 6. 7. 8.

Flowhead Complete - 61030 'O' rings - 2120013 Flowhead End Cap - 62006SPR Flow Conditioning Meshes - 42084 Flowhead Cone - 62019SPR Fleisch Element - 62055SPR Flowhead Body – 61020 Lubrication: Silicone Grease – 30961SPR

Figure 2: Flowhead Assembly

4. Clean each separate part of the flowhead by washing in a mild detergent

5. 6.

7. 8.

and removing particulate contamination. To clean the fleisch element, swill vigorously in water with mild detergent or use an ultrasonic bath. Do not attempt to “rub” or “scrub” at capillaries. The flowhead body (7) does not require disinfection, but may be cleaned/disinfected with the rest of the flowhead for convenience. Rinse all parts in clean water. Disinfect by immersion in sodium dichloroisocyanurate (NaDCC) solution at 1000 ppm concentration of free chlorine for 15 minutes. Prepare disinfectant solution as directed in the manufacturer’s guidelines. Rinse with very hot water to aid later drying. Leave to dry completely before reassembling. Drying the fleisch element components may require placing them in a warm place overnight. A drying cabinet is ideal.

Vitalograph ALPHA Service Manual 07371 Issue 1

Always follow the safety guidelines given by the manufacturer of cleaning and disinfectant chemicals.

Reassembling the Fleisch Flowhead 1. 2. 3.

4. 5.

6. 7. 8.

Examine the fleisch element to ensure that no liquid or particles remains in the holes, grooves or pressure tappings. After cleaning etc., check the 'O' rings for damage and ensure that they are correctly positioned within the grooves. Apply a very small amount of silicone grease to the ‘O’ rings and inside surfaces of the flowhead body. Wipe off any visible amounts of grease. Ensure that the tiny annular holes on the outside of the fleisch element are not blocked. When re-assembling the flowhead ensure that the blue pressure tapping is nearest to the largest diameter of the fleisch element. Ensure that the flowhead body is pushed fully home and rotate it so that the pressure ports are approximately 180° opposite the end of the fleisch element coil. Fit new flow conditioning meshes to both the flowhead cone and the flowhead end cap. Push the flowhead end cap onto the larger diameter of the fleisch element and push the flowhead cone onto the smaller diameter. When attaching the flowhead connection tube ensure that the matching ribbed pressure tappings on the flowhead and the Vitalograph ALPHA are connected to each other. It is recommended that an accuracy check is carried out following reassembly to verify correct operation and accuracy.

INSTRUCTIONS FOR USE For information on operating the Vitalograph ALPHA, refer to the User Manual.

CHECKING ACCURACY All spirometry standards (e.g. ATS/ERS/BTS/ANZRS) recommend checking the accuracy of lung function measuring devices at least daily with a 3-L syringe to validate that the instrument is measuring accurately. The Vitalograph ALPHA should never be outside accuracy limits unless damaged or in a fault condition. In this event, see the fault-finding guide. In normal use, calibration traceability certification is recommended as a part of the routine annual service. ATS recommendations require that the difference between the volume measured by the spirometer and the volume pumped into the spirometer from a syringe is within 3%. Follow the instructions in the User Manual to check the accuracy of the device.

Vitalograph ALPHA Service Manual 07371 Issue 1

FUNCTIONAL CHECK A functional check will be carried out using the Vitalograph Service Application software. This will involve the following checks: − Internal printer test − Sound test − Temperature sensor test − Display test

SOFTWARE CHECK The software version and issue can be determined from the About screen. Please quote this, and the serial number of the Vitalograph ALPHA, to Approved Manufacturers support desk when requesting further advice or assistance.

FAULT FINDING GUIDE Problem Fault Symptoms:

Accuracy Check variations > +/- 3% False readings suspected

Remedy:

• Check flowhead connection tube for holes. Ensure tube is correctly connected • Check flowhead cone fleisch element flow conditioning mesh for damage or blockages • Check flowhead fleisch element body pressure Port holes for blockages • Check flowhead fleisch element sealing or ‘O’ rings for damage • Ensure flowhead fleisch element is dried thoroughly – check that small holes are not blocked • Ensure that the flowhead fleisch element’s small holes are not blocked with lung debris • Ensure calibration syringe has not gone outside it’s calibration due date. • Adjust calibration (traceability certificate voided in this event). • Check main PCB by substitution • Return device to base.

Problem Fault Symptoms:

Test begins automatically Volume accumulates for 20 s without the subject

Vitalograph ALPHA Service Manual 07371 Issue 1

blowing Very small VC or FVC test displayed Remedy:

• Flowhead and/or tubing not stationary at the start of test. Hold them steady until the ‘READY’ prompt appears • Return to MENU and re-enter the test routine.

Problem Fault Symptoms:

Damaged or missing rubber feet Rocking device

Remedy:

Replace all 6 rubber feet.

Problem Fault Symptoms:

Dirty flowhead Incorrect or no measurements (volume or temperature)

Remedy:

Clean the flowhead thoroughly

Problem Fault Symptoms:

Tubing connected incorrectly Reversed or no volume measurements

Remedy:

•

Ensure that the ribbed side of the tubing is connected to the ribbed half of the connector on the device and the blue tapping on the flowhead connector Ensure that the tubing is not pinched or trapped. Check both the flowhead connecting tube and the internal silicon tube connected to the transducer.

Problem Fault Symptoms:

Internal printer failure Cannot print to internal printer

Remedy:

• • • • • •

Problem Fault Symptoms:

Check that the internal printer is selected in the Configuration menu Check the internal printer cables by substitution Check that paper is loaded correctly and not reversed Check the printer by substitution Check main PCB by substitution Return device to base.

Test report to Vitalograph Reports Utility failure. Cannot send report to Vitalograph Reports Utility

Vitalograph ALPHA Service Manual 07371 Issue 1

Remedy:

• • • • •

Check that Vitalograph Reports Utility is selected in the Configuration menu Check USB cable Check printer as per manufacturer’s instructions Check main board by substitution Return device to base.

Problem Fault Symptoms:

LCD failure Cannot read LCD

Remedy:

1. Check contrast adjustment 2. Blank screen: − Check display by substitution − Check LCD PCB by substitution − Check LCD FFC. − Check main PCB by substitution 3. Return device to base.

Problem Fault Symptoms:

Keypad failure Buttons fail to activate correctly

Remedy:

1. Check cable connection to main PCB 2. Check keypad PCB by substitution 3. Check keypad FFC 4. Check main PCB by substitution 5. Return device to base.

For further advice, please contact your Vitalograph distributor.

INSTRUMENT ACCESSIBILITY Switch the mains power OFF and disconnect the power supply from the back of the instrument. Remove the flowhead connection tube from the connector on the base. Turn the unit upside down and place on a foam mat or other soft surface to avoid damage to fascia. Remove the rubber feet and the tamper evident seal as indicated in figure 3. Remove the seven screws under the rubber feed and tamper evident seal.. NOTE: DO NOT ATTEMPT TO REMOVE THE BASE AT THIS STAGE. STATIC SENSITIVE DEVICES INSIDE.

Vitalograph ALPHA Service Manual 07371 Issue 1

Figure 3: Underside view indicating rubber feet / tamper evident seal and screws to be removed for internal instrument access.

1. Printer Cables 2. LCD Cable 3 Keypad Cable

Figure 4: Top cover being removed for internal instrument access Copyright Vitalograph 2007

Vitalograph ALPHA Service Manual 07371 Issue 1

Internal Testing Disconnect internal battery leads, keypad, LCD and printer leads and leave disconnected during the following service checks. NOTE: TAKE EXTRA CARE WHEN DISCONNECTING THE KEYPAD CABLE AS THIS IS SHORT AND CAN COULD GET DAMAGED. PowerSAFE Supply Voltage The power supply 12V DC voltage can be measured as follows using a voltmeter: 1. Connect positive voltmeter test probe to the inner centre contact of the PowerSAFE barrel jackplug. Connect the negative voltmeter test probe to the outer contact of the PowerSAFE barrel jackplug. The specification for this voltage is 11.4V to 12.6V DC. If out of tolerance, replace the PowerSAFE. 2. Connect the voltmeter negative test probe to the 0V point on the main PCB and connect the voltmeter positive test probe to the connection point indicated in Appendix D. Internal Power Supplies Check that the power supply DC voltages generated on the main PCB are correct. These are measured between the 0V point (TP2) and the relevant voltage test points marked on the board. (See Appendix D) The voltage specifications are as follows:

+11.00 to +13.00V at TP1 0V at TP2 +3.25V to + 3.35V at TP3 +4.90V to +5.10V at TP4 +1.75V to +1.85V at TP5 +4.80V to +5.20V at TP6 -9.00V to –11.00V at TP7 +14.00 to +16.00V at TP8 +2.80V to +3.20V at TP11 +6.00V to +6.20V at TP12 +2.45V to + 2.55V at TP13 +3.25V to + 3.35V at TP14 +4.90V to +5.10V at TP15 +1.85V to + 1.95V at TP16 +11.2V to +12.2V at TP18 +3.25V to + 3.35V at TP21 +3.25V to + 3.35V at TP25 -11.50V to –12.50V at TP26 +9.00V to +11.00V at TP27

Vitalograph ALPHA Service Manual 07371 Issue 1

If out of tolerance, replace the main PCB (Part no 65103). Battery for RTC Replace battery for RTC. Part of the service kit 65170 Fuse Check fuse is correct. Re-assembly is the reverse procedure of disassembly. Please ensure all cables are properly connected and not trapped.

REPLACING PARTS THE FITTING OF ANY SPARE PARTS SHOULD BE CARRIED OUT BY TRAINED AND QUALIFIED SERVICE TECHNICIANS ONLY.

LCD Screen (65042) & LCD PCB (65043) Refer to figures 3 and 4 for internal instrument access. Lay the top cover face down on a soft surface and remove the 4 screws retaining the LCD and backing plate assembly (See figure 5). Remove the backing plate from the top cover, taking care to feed the FFC cable and LCD PCB through the slot in the backing plate. Remove the LCD from the top cover. Check the condition of the LCD sealing strip attached to the top cover. This prevents contamination of the device from dust and dirt. Remove the plastic insulating tape from around the LCD PCB. Disconnect the FFC cables from the both end of the PCB. Replace the LCD or the LCD PCB as required. Re-assembly is the reverse order of assembly.

Keypad PCB (65044) Refer to figures 3 and 4 for internal instrument access. Lay the top cover face down on a soft surface and remove the 4 screws retaining the keypad PCB and backing plate assembly (See figure 5). Remove the FFC from the keypad PCB. Replace the keypad PCB, ensuring the 4 pips on the keypad line up with the corresponding holes on the PCB. Re-assembly is the reverse order of assembly.

Printer (67054) Refer to figures 3 and 4 for internal instrument access. Lay the base plate face on a soft surface. Remove the two cables from the printer. Remove the four screws to detach the printer from the support plate. (See figure 5). Replace the printer. Re-assembly is the reverse order of assembly.

Vitalograph ALPHA Service Manual 07371 Issue 1

1. LCD screen and backing plate assembly 2. Keypad and backing plate assembly

Figure 5: Internal view – Top Half Parts Identification

Main PCB Service Exchange – 65045 Disconnect the rechargeable battery connect from the PCB. Disconnect the power connector from the PCB. Disconnect the On/Off connector from the main PCB. Disconnect the thermister connector from the main PCB. Remove the two cables from the printer. Remove the four screws to detach the printer from the support plate. Remove the four screws to detach the printer support plate from the base. Remove the nine nuts from the PCB. Push in the Compact Flash eject button as far as possible. Push the PCB as far to the left as possible. Deflect the right wall of the base out slightly and lift the PCB out from the base. Fit the replacement PCB in reverse order to the removal procedure.

Power Inlet Socket - 311209 Refer to figures 3 and 4 for internal instrument access. The power inlet socket is a screw fit into the base and is connected to the main PCB via discreet wires (see figure 6). These should be unsoldered at the socket and the replacement fitted in its place.

Vitalograph ALPHA Service Manual 07371 Issue 1

1. Main PCB – 65110 2. On/Off switch- 311338 3. Power Inlet socket311209 4. LCD PCB Connector 5. Keypad PCB Connector 6. Thermister Connector 7. Battery Connector 8. Printer and backing plate assembly

Figure 6: Internal view – Bottom Half Parts Identification

On/Off Switch – 311338 Refer to figures 3 and 4 for internal instrument access. The On/Off switch is a snap fit into the base and is connected to the main PCB via discreet wires (see figure 6). These should be unsoldered at the On/Off switch and the replacement fitted in its place.

ROUTINE ANNUAL SERVICE Training & Qualifications Required To Perform Service Procedure Vitalograph runs a range of service training and Technician Conversion Courses for qualified technicians on a periodic basis, dependent upon demand. These courses are open to all suitably qualified medical device technicians, but a charge is made to cover costs. A pre-qualification questionnaire must be completed to ensure suitable background training/experience has been attained by

Vitalograph ALPHA Service Manual 07371 Issue 1

the delegates. Typically medical service technicians will have completed a 4-year biomedical equipment technician apprenticeship and/or be qualified to HNC or HTech in electronics or a similar speciality and will be trained to work in a medical facility. For any particular product, a lesson plan used in conjunction with the Service Manual can be used in a ‘conversion course’ to train service technicians. Training will be needed in addition to that in this manual, dependent upon the facility and other procedures in use, e.g. Hygiene, Safety, Service Procedure, Control of Service Equipment.

Service Tools Special Tools Required A traceable precision syringe of 1 or 3 litres will be required. Otherwise there are no special tools required for the routine normal service of this product.

PPM Service Kit Kit of components necessary for the routine annual Planned Preventive Maintenance on this product: Cat Number 65170 Service Kit for Vitalograph ALPHA.

Service Procedure A sample Service Sheet to act as a checklist for trained technicians to carry out the Planned Preventive Maintenance procedure follows. It is permissible to copy the Service Sheet solely for this purpose.

Vitalograph ALPHA Service Manual 07371 Issue 1

No: PP QA Reference of Servicing Organisation

Serviced by:

PLANNED PREVENTIVE MAINTENANCE SERVICE Vitalograph alpha Service Schedule ACCURACY CHECK RECORD Pre-Service Reference Volume Volume Recorded Difference

_________L _________L _________%

Serial No. ACCURACY CHECK RECORD Post- Service Reference Volume Volume Recorded Difference

_________L _________L _________%

NOTE HERE IF SPIROMETER PRE-SERVICE ACCURACY CHECK OUT OF TOLERANCE

FLOWHEAD AND TUBING Replace Element, O Rings, Cone, Meshes & Twintubing Check Pressure Tappings Flowhead / Instrument

ELECTRONICS & FIRMWARE

Previous Measurements were out by _________% Over- Under- Reading (delete as applicable)

CLEANING & HYGIENE

Check Version/Issue of Software General Damage Check Inspect LCD Glass & Display (Damage etc.) Check LCD Contrast Check External Communication Leads/Cables Digitize Keypad Check Internal Leads and Connections Check PCB Input Voltage (11.4-12.6 V) Internal Power Supplies Replace Battery for RTC Check Internal Fuse Rating Ensure all Screws and Fasteners are Locked

ELECTRICAL SAFETY TESTING Check Suitable Mains Plus – Fuse? Mains Cable Outer Sheath & IEC Connector PowerSAFE: Casing/Cable/Jackplug/Output Voltage

Clean Print Head & Brush. Clean Print Rollers Air Dust PCB & All Internals Clean & Disinfect Outer Casing, PowerSAFE & Lead

Check All Breathing Circuit Components Replaced

SERVICE UTILITY Service Utility/Diagnostics. Up-date Service Message

FUNCTIONAL TEST Certify Calibration for New Flowhead Perform VC & FVC Test Procedure Using Syringe Final Accuracy Check and Print (Leave in Printer) Apply “Clinically Clean” Label Fix Warranty Seal

RECORD KEEPING Issue Calibration Certificate for Spirometer Certify accuracy of Precision Syringe Affix “Next Service Due” Label to Spirometer Complete Service Records Customer’s Signature

SPECIAL ADVICE TO USER:

PRECISION SYRINGE CERTIFICATION Customer’s Syringe S/No: Nominal Volume __________ Check Capacity: __________L Check General Condition (ring) Yes/No Traceable Tool/Syr Serial No. _________ Complete and Affix Label to Syringe Technician’s Syringe used – Syringe No.

Software Upissued Yes/No User Advised Yes/No

Service Technician: I hereby Certify this Instrumentation to be Safe, Clinically Clean and in Proper Working Order. Name: Signature:

Date:

Calibration of Spirometer Certified Traceable to International Standards as above.

Vitalograph ALPHA Service Manual 07371 Issue 1

CONSUMABLES AND ACCESSORIES Cat. no 20242 20303 28350 20408 36020 42084 66149 67056 67252 41195 41196 41197 41198 61030 42029SPR 65354 41200 65030SPR

Description

SafeTway Mouthpieces (200) Nose Clips (200) BVF (50) 1-L Precision Syringe 3-L Precision Syringe Flow Conditioning Mesh (10) Thermal Printer Paper (5) Serial Cable USB Cable 12V DC Power Supply 2 Pin Mains Input Module (EU) 3 Pin Mains Input Module (UK) 2 Pin Mains Input Module (USA) Flowhead Complete Flowhead ConnectionTube CD with User Manual Test Storage Data Card Vitalograph Reports Utility

Contact Vitalograph for Spares List. Vitalograph reserves the right to add and remove items from the above lists, and to offer alternative parts and assemblies. Please contact one of the addresses given at the front of this manual to confirm availability before committing to a repair or service requiring any particular part.

TECHNICAL SPECIFICATIONS NOTE: See User Manual for technical specifications. Contact Vitalograph or visit www.vitalograph.com to download a PDF copy of the User Manual.

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