Alpha 3 _081052

Vitalograph!

ALPHA III MODEL 6000 SERVICE MANUAL

CERTIFIED UNDER THE MEDICAL DEVICES DIRECTIVE

Copyright Vitalograph 2000, 2003 081052 Issue 7 2

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 (Ireland) 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 2001, 2003 Current Edition (Issue 7) Cat. No. 081052 Vitalograph is a registered trademark.


Table Of Contents

INTRODUCTION................................................................................................................................................4

SYSTEM CONFIGURATION .............................................................................................................................5

ACCURACY CHECK & CALIBRATION ADJUSTMENT .................................................................................6 Recommended Accuracy Checking Procedure .............................................................................................6

CLEANING & DISINFECTING ..........................................................................................................................8 General Recommendation..............................................................................................................................8 Routine Practice .............................................................................................................................................8 Table of Materials used & cleaning/disinfection methods ..............................................................................8 Disassembling the Flowhead for Cleaning and Disinfecting ..........................................................................9 Reassembling the Fleisch Flowhead..............................................................................................................9

FUNCTIONAL CHECK ....................................................................................................................................11

INSTRUMENT ACCESSIBILITY .....................................................................................................................12 Internal Testing .............................................................................................................................................13

PowerSAFE Supply Voltage .....................................................................................................................13 Internal Power Supplies ............................................................................................................................13 LCD Contrast Control................................................................................................................................13 Software: ...................................................................................................................................................13

REPLACING PARTS.......................................................................................................................................14 Keypad Complete - 61040............................................................................................................................14 ALPHA Display - 60023SPR ........................................................................................................................14 PCB & Printer - 61024 ..................................................................................................................................14 LCD Display Glass - 44011SPR...................................................................................................................14 LCD Surround - 61039 .................................................................................................................................14 Paper Roll Clip - 61018.................................................................................................................................15 Paper Tear Bar - 61019................................................................................................................................15 Main PCB Service Exchange - 61023 ..........................................................................................................15 Contrast Control with Knob - 31583SPR......................................................................................................15 Power Inlet Socket - 31625SPR ...................................................................................................................15

ROUTINE ANNUAL SERVICE ........................................................................................................................17 Training & Qualifications Required To Perform Service Procedure.............................................................17 Special Tools Required ................................................................................................................................17 PPM Service Kit ............................................................................................................................................17 Service Procedure ........................................................................................................................................17

CONSUMABLES, ACCESSORIES AND SPARE PARTS .............................................................................19 Consumables/Accessories ...........................................................................................................................19 Spare Parts...................................................................................................................................................19

TECHNICAL SPECIFICATIONS .....................................................................................................................20

APPENDIX A: CIRCUIT DIAGRAM ...............................................................................................................21

APPENDIX B: FUNCTIONAL BLOCK DIAGRAM ........................................................................................22

APPENDIX C: FAULT FINDING GUIDE.........................................................................................................23

APPENDIX D: SAMPLE RISK ASSESSMENT...............................................................................................25


INTRODUCTION The Vitalograph ALPHA III is a desktop electronic spirometer which is certified to meet IEC601-1 safety standards and ATS 1994 Spirometry Standards in all respects: accuracy, performance, back pressure, minimum detectable flow rate and test duration. The Vitalograph ALPHA III also complies with all other major spirometry standards: ERS93; BTS; APRS; OSHA; and other relevant standards. This Service Manual should be used in conjunction with the Vitalograph ALPHA III User Manual , and is intended for use by suitably trained/qualified technicians only. ESD and Health and Safety precautions are to be observed when working on this equipment. For further assistance, or to find the address of your approved Vitalograph Service Centre, please contact Vitalograph at one of the addresses given in CUSTOMER SERVICE at the rear of this manual


SYSTEM CONFIGURATION The Vitalograph ALPHA measures respiratory air with a Fleisch No4 size pneumotachograph type flowhead. Inside the flowhead is a resistive element (1) - a series of small parallel capillary tubes which simulate laminar flow in the air passing through it. This creates a differential pressure in the tappings which is directly proportional to flow rate. This is detected by a differential pressure transducer (2) inside the instrument enclosure. The output voltage from the ultra-low range pressure transducer converts the signal electrically which is sampled at 100 Hz. A microprocessor integrates these signals for measurement and display.

Figure 1 : Operating Principle The flowhead is attached to the Vitalograph ALPHA by dual silicone tubing (Flowhead Connection Tube). Ensure that both the coloured tapping on the flowhead and on the Vitalograph ALPHA is connected to the ribbed side of the flowhead connection tube. The Vitalograph ALPHA MUST be used with the purpose-built low voltage PowerSAFE unit with which it is supplied. Attempted use with other power sources may cause irreparable damage and invalidate the warranty. The output from the PowerSAFE is 10 volts DC. There is no high voltage inside the Vitalograph ALPHA. The jackplug from the PowerSAFE connects into the socket on the right hand side of the Vitalograph ALPHA. The IEC connector on the mains lead plugs into the socket on the PowerSAFE. Plug the mains plug into a suitable socket, operate the ON/OFF switch on the right hand side of the instrument and the Vitalograph ALPHA is ready for use and will prompt the operator to verify the date - please refer to the user manual for full instructions. ENSURE THAT THE PAPER ROLL IS FITTED CORRECTLY


ACCURACY CHECK & CALIBRATION ADJUSTMENT An accuracy check should be performed as required by your own quality control procedures and the calibration should be certified (traceable to international standards) annually. Most spirometry standards recommend checking accuracy ‘at least daily’. Accuracy should also be verified after Cleaning/Disinfecting the flowhead or any other Disassembly/Re-assembly of the flowhead. The accuracy check routine allows the user to simply check and validate the accuracy of the spirometer. In the unlikely event that the spirometer is reading outside its precision tolerance, first re-check the procedure, spirometer and syringe before considering adjusting the calibration setting. Then follow carefully the instructions on the screen. The adjustment is carried out totally by control from the keyboard and no mechanical adjustment is necessary. The revised calibration is retained until altered again, even whilst the machine is switched off and disconnected from the power supply. To perform the accuracy check a Precision Syringe is required. These are usually 1-L or 3-L. Before checking accuracy it is essential that the flowhead and syringe are at the same temperature. This can be assured by pumping room air through the flowhead using the syringe, prior to entering the accuracy check routine.

Recommended Accuracy Checking Procedure 1. Connect the Vitalograph ALPHA to a 1-L precision syringe (Cat. No. 20408) as shown in fig. 2. 2. From the MAIN MENU, select ‘CALIBRATION CHECK’ 3. The user is instructed to ensure the flowhead is at ambient temperature. This is done by pumping

room air through the Flowhead a number of times. Then follow the on screen instruction to continue.

Figure 2 : Checking Accuracy of the Vitalograph ALPHA 4. The user is prompted to confirm or enter the ambient temperature when the accuracy check

routine is initiated. THIS MUST BE MEASURED ACCURATELY. 5. Follow the on-screen instructions until prompted to pump air through the flowhead. Ensure that the

syringe piston is withdrawn fully before starting. 6. Push the syringe piston forward one full stroke taking at least 1 second to complete the stroke.

Wait for the display to show recorded volume and the next instruction - the syringe piston may now be withdrawn fully again.

7. Repeat strokes of the syringe 3 times, following the on-screen instructions to complete and exit the routine. It is important to wait for at least half a second after the syringe fills to allow the system to settle between strokes.

8. The user is prompted to enter the volume used for the Accuracy check. Using this example, 3 would be entered, because the reference volume injected was 3 litres..

The volume measured and % difference from actual is shown, and the user is offered the option of updating the calibration. This is ONLY necessary IF THE ERROR IS GREATER THAN +/-3%. In the unlikely event that the spirometer is reading outside its precision tolerance, first re-check the procedure,


spirometer and syringe before considering adjusting the calibration setting. Then follow carefully the instructions on the screen. At the end of the routine there is a choice of either ending the routine or double checking the result by re-entering the calibration procedure as described above. Finally a printed record may be obtained. A CALIBRATION REPORT will be printed if the calibration has been updated. Normally an ACCURACY CHECK will be printed if the accuracy check revealed calibration in tolerance.


CLEANING & DISINFECTING

General Recommendation To reduce the risk of cross infection the use of SafeTway mouthpieces for expiratory only testing, or Bacterial Viral Filters for Inspiratory / Expiratory testing, is recommended. A Risk Assessment should be carried out to assess the risks presented to both operator and subject, 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 D) An assessment should be made of methods of decontamination available to the operator, and their effectiveness against potential risks - a table of materials used in the Vitalograph ALPHA is provided below to assist in this. It is recommended that in cases of high risk with no effective disinfection methods available, that the contaminated parts are disposed of. For this device, the Flowhead Assembly: FLOWHEAD COMPLETE and the FLOWHEAD CONNECTION TUBE.

Routine Practice A new mouthpiece (either SafeTway or Bacterial Viral Filter) should be used for each subject. A delay of at least 5 minutes should be allowed between subjects to allow settling of previously aerosolised particles in the measuring device. It is recommended that the Flowhead Assembly be regularly cleaned according to the guidelines of the user’s facility. In the event of visible contamination to the FLOWHEAD CONES or FLOWHEAD ELEMENT - these should be cleaned and disinfected. The FLOW CONDITIONING MESHES should be replaced regularly. The frequency of this is dependent on the Facilities’ Risk Assessment, usage, and test environment, but should be at least monthly or every 100 subjects (500 blows). They should also be replaced in the event of damage, or if visibly contaminated. It is recommended to replace the complete Flowhead Assembly: FLOWHEAD COMPLETE and FLOWHEAD CONNECTION TUBE at least annually. Refer to Figure 3 for identification of parts.

Table of Materials used & cleaning/disinfection methods Part Material Clean/

DisinfectAutoclave Recommended Disinfectants

Case Exterior Polystyrene High Density foam with epoxy paint

Clean No Wiping with a 70% Isopropyl Alcohol impregnated cloth provides a suitable form of cleaning and

Display Glass Clean No low-level disinfection. This may be Screen Surround ABS Clean No preceded by cleaning with an anti- Keypads ABS Clean No static foam cleaner if necessary. White Flowhead Tube Silicone Rubber Clean Viable Fleisch Element Assembly

Aluminium, Stainless Steel Clean Viable Disinfect by immersion in sodium dichloroisocyanurate solution

Flowhead Body Aluminium & Acetyl Clean & Disinfect

No at 1000 ppm concentration of free chlorine for 15 minutes. (see below

Flowhead Cone TPX Clean & Disinfect

Viable for recommended cleaning/disinfection method for

Flowhead End Cap TPX Clean & Disinfect

Viable the Vitalograph Alpha Flowhead) The flowhead may also be

Flow Conditioning Mesh

Acetyl and Polyester Disinfect Dispose

No disinfected by autoclaving at 134°C for 3 minutes

All 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 also require disinfecting.


Definitions of cleaning and disinfection are as defined in “Sterilization, Disinfection and Cleaning of Medical Equipment: Guidance on Decontamination from the 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 Assembly, place the Fleisch Element

Assembly 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 3 shows the various parts that make up the Flowhead Assembly.

1. Flowhead Complete - 61030 2. 'O' rings - 2120013 3. Flowhead End Cap - 62006SPR 4. Flow Conditioning Mesh - 42084 5. Flowhead Cone - 62019SPR 6. Fleisch Element Assembly - 62055SPR 7. Flowhead Body – 61020 8. Light lubrication: Silicone Grease – 30961SPR

Figure 3: Flowhead Assembly

Clean each separate part of the flowhead by washing in a mild detergent to remove 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 does not require disinfection, but may be cleaned/disinfected with the rest of the flowhead for convenience.

Rinse with 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 hot water to aid drying. Leave to dry completely before reassembling. Drying the Fleisch element assembly may require

placing it in a warm place overnight. A drying cabinet is ideal, alternatively another heat source could be used. If a small fan unit is available (as in the base station), this may also be used to dry the Fleisch element by adapting to blow down through the Fleisch element.

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

Reassembling the Fleisch Flowhead 1. Ensure that no liquid remains in the holes, grooves or pressure tappings of the Fleisch element

assembly. 2. After cleaning etc. check the 'O' rings for damage and ensure that they are correctly positioned

within the grooves. 3. Apply very small amount of silicone grease to ‘O’ Rings and inside surfaces of FLOWHEAD BODY.

Wipe off any visible amounts of grease. Ensure that the tiny annular holes on the outside of the FLEISCH ELEMENT ASSEMBLY are not blocked.

4. When re-assembling the FLOWHEAD ensure that the blue pressure tapping is nearest to the largest diameter of the FLEISCH ELEMENT ASSEMBLY.

5. 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.

6. Fit new FLOW CONDITIONING MESHES to both the FLOWHEAD CONE and the FLOWHEAD END CAP.


7. Push the FLOWHEAD END CAP onto the larger diameter of the FLEISCH ELEMENT ASSEMBLY and push the FLOWHEAD CONE onto the smaller diameter.

8. When attaching the FLOWHEAD CONNECTION TUBE ensure that the matching coloured pressure tappings on the Flowhead Assembly and the Vitalograph ALPHA are connected to each other.

9. It is recommended that an accuracy check is carried out following reassembly to verify correct operation and accuracy.


FUNCTIONAL CHECK It is recommended that the following functional check be carried out on the Vitalograph ALPHA on a regular basis: • Check Fleisch Element Assembly for damaged 'O' rings. • Check that there is adequate lubrication, without excess • Check the Flowhead Connection Tube for signs of damage. • Perform an Accuracy Check procedure. • Perform an FVC test and check values • Check LCD function. • Check printer function. Refer to Appendix C, Fault Finding Guide, if difficulties are experienced with any of the above checks


INSTRUMENT ACCESSIBILITY Switch the mains power OFF and disconnect the power supply from the side 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 seven screws indicated in figure 3. NOTE: DO NOT ATTEMPT TO REMOVE THE BASE AT THIS STAGE.

Figure 4 : Underside view indicating screws to be removed

for internal instrument access

Figure 5 : Case moulding being removed for internal instrument access


Internal Testing Refer to previous section (Instrument Accessibility) and remove the instrument case. Disconnect Printer, LCD and Keypad leads, and leave disconnected during the following service checks.

PowerSAFE Supply Voltage The power supply 10V DC voltage can be measured as follows using a voltmeter: 1. Connect negative voltmeter test probe to the inner centre contact of the PowerSAFE barrel

jackplug. Connect the positive voltmeter test probe to the outer contact of the PowerSAFE barrel jackplug. The specification for this voltage is 9.5V to 10.5V DC. If out of tolerance, replace the PowerSAFE.

2. Connect the voltmeter negative test probe to the 0V Test Point (TP12) at the input connection to the MAIN PCB and connect the voltmeter positive test probe to the connection adjacent to TP12 marked as +.

The specification for this voltage is 9.5V to 10.5V DC.

Internal Power Supplies Check that the power supply DC voltages generated on the MAIN PCB are correct. These are measured between the zero volt negative Test Point (TP12) and the relevant voltage positions marked on the board. The voltage specifications are as follows:

+5V : 4.90V to 5.10V DC +5V Printer Supply : 4.90V to 5.10V DC +10V : 9.6V to 10.4V DC -10V : -9.6V to -10.4V DC -12V : -11.26V to -13.19V DC

If out of tolerance, replace the MAIN PCB (Part no 61023)

LCD Contrast Control This device is designated RV2 on the MAIN PCB. To check that it is working correctly, switch off the instrument and disconnect the Power Supply. With an ohm meter measure the resistance of the Contrast Control solder connection (10) of LCD lead and the -12 Volt position marked on the PCB. Rotate the control knob and the reading on the ohm meter should vary from approximately zero ohms to 26.5 kOhms. If the reading is a fixed value of 22 kOhms wherever the control knob is set or the reading is erratic, then the CONTRAST CONTROL WITH KNOB (part no 31583SPR) should be replaced. N.B. Reconnect the Printer, LCD and Keypad leads after completing these tests and reassemble the unit. When attaching the FLOWHEAD CONNECTION TUBE ensure that the matching coloured pressure tappings on the Vitalograph ALPHA and the Flowhead Assembly are connected to each other.

Software: The software version and issue can be determined from the cartridge label or printout. Please quote this, and the serial number of the Vitalograph ALPHA, to Approved Manufacturers support desk when requesting further advice or assistance.


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

Keypad Complete - 61040 Refer to figures 3 & 4 for internal instrument access. Lay the case moulding face down on a soft surface and remove the four screws retaining the keypad PCB. Lift away the PCB which will expose the rubber membrane. Remove the complete membrane at this stage and discard it. Remove the old keypad moulding and keys (Note: it may be necessary to turn the unit over and push them in from the front). Fit the new keypad moulding to the case moulding and drop the keys into their apertures. The new rubber membrane locates over the rear face of the keypad moulding (it will only fit one way) and is trapped by fitting the new PCB. Ensure free operation of the keys before finally tightening the fixing screws. Ensure ferrite on Keypad cable is as close to main PCB as possible.

ALPHA Display - 60023SPR Refer to figures 3 & 4 for internal instrument access. Remove the four screws retaining the display in the case moulding and lift out the display. The foam tape provided has a liner on the rear face which when removed will expose a self adhesive surface. Cut the foam tape to length and stick it around the perimeter of the metal housing on the new display (refer to the removed display for correct positioning). This prevents dust from entering between the display and the glass. Re-assembly is a reversal of the removal procedure.

PCB & Printer - 61024 Refer to figures 3 & 4 for internal instrument access. The printer board is retained in the case moulding by five screws. Replacement of the complete assembly is achieved by removing these five screws and replacing the board. Do not attempt to fit a new printer to the existing printer board - always use a replacement assembly. Ensure ferrite on Printer cable is as close to main PCB as possible.

Figure 5 : Internal view - Top Half Parts Identification

LCD Display Glass - 44011SPR Refer to figures 3 & 4 for internal instrument access. Remove the four screws retaining the LCD and remove the display. The display glass is held in place by double sided adhesive tape. To remove, push carefully on the front face and lift clear. Ensure that no residual tape is left in the recess on the case. Fit the new part into the recess using the new tape provided.

LCD Surround - 61039 The LCD surround is fitted to the case using double sided adhesive tape. To remove it simply lever it out of its location, remove any residual tape from the case and fit the replacement using the tape provided.

1. Keypad Complete -61040 2. LCD Display - 60023SPR 3. Printer with Board - 61024


Paper Roll Clip - 61018 Refer to figures 3 & 4 for internal instrument access. The paper roll clip is retained by two nuts found on the inside of the case moulding. Remove the nuts and fit the replacement part in reverse order to the removal procedure.

Paper Tear Bar - 61019 Refer to figures 3 & 4 for internal instrument access. Remove the printer board assembly (refer to Printer with Board - 61.024 fitting instructions). The tear bar is retained by two spring clips which must be prized carefully from their locating pins. Replacement is a reversal of the removal procedure.

Main PCB Service Exchange - 61023 Remove the plastic tubes from the pressure tappings and slide the power inlet socket out of its retaining slot in the base. Remove five nuts from the edges of the PCB and where necessary, the two outer nuts from the heat sink plate. Do NOT remove the inner two nuts on the heat sink plate or the two nuts which hold the heat sink and the PCB together. Lift the PCB from the base studs and remove the complete assembly. Where necessary clean the heat sink compound from the base around the heat sink mounting position. Where necessary shear off two studs underneath the heat sink plate. Ensure the plastic spacers are fitted to the five studs that support the PCB and fit the new PCB into position. Replace five nuts to secure PCB - do NOT over tighten. Refit the power inlet socket. Refit the plastic tubes to the pressure tappings.

Contrast Control with Knob - 31583SPR Refer to figures 3 & 4 for internal instrument access. Removal of the main PCB is required when replacing this component (refer to Main PCB Service Exchange - 61023 fitting instructions). The Contrast Control is soldered to the main PCB. It must be unsoldered and the replacement part soldered into position. Ensure that the replacement is pushed down squarely onto the board before re-soldering, to maintain correct alignment.

Power Inlet Socket - 31625SPR Refer to figures 3 & 4 for internal instrument access. The power inlet socket is a slide fit into the base panel and is connected to the main PCB via discreet wires; these should be unsoldered at the socket and the replacement fitted in its place.

54

3

2

1

Figure 6 : Internal view - Bottom Half Parts Identification

1. Main PCB Service Exchange - 61023 2. Contrast Control with knob - 31583SPR


3. On/Off Switch - 31639SPR 4. Pressure Inlet Ports - 60039SPR 5. Power Inlet Socket - 31625SPR


ROUTINE ANNUAL SERVICE

Training & Qualifications Required To Perform Service Procedure Vitalograph runs a range of service training and EBME 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 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 used in a ‘conversion course’ to train service technicians. Training will be needed in addition to those 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 Calibration 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 No. 61051 Service Kit for ALPHA III.

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


No: PPM

QA Reference of Servicing Organisation:

Serviced by:

Planned Preventive Maintenance Service Vitalograph ALPHA III Service Schedule Serial No: ACCURACY CHECK RECORD Pre-Service ACCURACY CHECK RECORD Post-Service Reference Volume L Reference Volume L Volume Recorded L Volume Recorded L Difference _____% Difference _____% FLOWHEAD AND TUBING* NOTE HERE IF SPIROMETER PRE-SERVICE Replace element, O rings, cone, meshes & twin- ACCURACY CHECK OUT OF TOLERANCE tubing Previous Measurements were out by _____% Spray & Bag element & O rings; Dispose Cone, Over- Under- Reading (delete as applicable) meshes & tubing CLEANING & HYGIENE Check pressure tappings flowhead / instrument Clean Print Head & Brush clean Print Rollers ELECTRICAL SAFETY TESTING Air dust PCB & all internals Check suitable mains plug - fused? Clean & Disinfect outer casing, PowerSAFE & Lead Mains Cable Outer Sheath & IEC Connector Check all breathing circuit components replaced PowerSAFE: Casing/cable/jackplug/output voltage CALIBRATION & FUNCTIONAL TEST ELECTRONICS & FIRMWARE Adjust Calibration for new flowhead Check Version/Issue of Software Perform VC & FVC test Procedure using syringe General Damage Check Final Accuracy check and print (Leave in Printer) Inspect LCD Glass & Display Apply “Clinically Clean” Label Check LCD Contrast RECORD KEEPING Check Print Quality Issue Calibration Certificate for Spirometer Check Operation of Keypad - 12 Buttons Issue Calibration Certificate for Precision Syringe Check Internal Leads & Connections Affix Next Service due label to Spirometer Check internal fuse rating Complete Service Records Check PCB Input Voltage (9.5-10.5V) Customer’s Signature Internal Power Supplies: +5V; Prt +5; +10; -10; -12 Check Contrast Potentiometer Ensure all screws & Fasteners are locked SPECIAL ADVICE TO USER:

Software Upissued YES/NO User Advised YES/NO Technician’s Syringe Used - Serial No: * Items are not part of the interim service Service Technician:

I hereby Certify this instrumentation to be safe, clinically clean and in proper working order.

Name: Calibration of Spirometer & Syringe Certified as above. Signature: Date:


CONSUMABLES, ACCESSORIES AND SPARE PARTS

Consumables/Accessories Cat. no Description 20242 SafeTway Mouthpieces (200) 20303 Nose Clips (10) 28350 Bacterial/Viral Filters (50) 20408 1-L Precision Syringe 36020 3-L Precision Syringe 42084 Flow Conditioning Mesh (10) 44058 Thermal Printer paper (5)

Spare Parts 30961SPR Silicone Grease 31297SPR 3 Pin Mains Power Cable with 5A fuse (UK) 31375SPR 2 Pin Mains Power Cable (USA) 31376SPR 2 Pin Mains Power Cable (International) 31583SPR Contrast Control with Knob 31625SPR Power inlet Socket 42028SPR Flowhead Retaining Strap 42029SPR Flowhead Connection Tube 44011SPR LCD Display Glass 44015SPR Paper Roller 44048SPR Vitalograph ALPHA Carrying Case 60023SPR ALPHA Display 60039SPR Pressure Inlet Ports 61018 Paper Roll Clip 61019 Paper Tear Bar 61020 Flowhead Body 61023 Main PCB ALPHA III S/X 61024 PCB & Printer ALPHA III S/X 61030 Flowhead Complete 61039 LCD Surround 61040 Keypad Complete 62006SPR Flowhead End Cap 62019SPR Flowhead Cone 62055SPR Fleisch Element Assembly 21001204 Standard PowerSAFE 2120013 'O' rings 61051 Service Kit for ALPHA III * S/X = Service Exchange. With service exchange parts, the faulty board must be returned without evidence of tampering or the full cost of board will be charged. Vitalograph reserve 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 rear of this manual to confirm availability before committing to a repair or service requiring any particular part.


TECHNICAL SPECIFICATIONS Flow detection principle: Fleisch type Pneumotachograph

Volume measurement: Flow integration

Accuracy better than: Volume ±3% or ±0.05L whichever is greater, Flow ±5% or

±0.2L/s whichever is greater(Inspiratory: ±5% vol., ±8% flow)

Certified Performance Standard: American Thoracic Society 1994

Certified Safety Standard: CE Mark - MDD 93/42/EEC EN60601-1 & -2

Max. displayed volume: 8 Litres

Max. displayed flow rate: 16 Litres/sec

Max. test duration: 20-s FVC / 20-s VC

Back pressure: 0.044kPa/L/s (0.45cm H2O) at 14 L/s

Printing paper: Thermally sensitive 112mm wide (coating inside)

Printer speed: 36 lines per minute

Characters per line: 42 max.

Display: LCD graphics panel 240x64 pixels

Microprocessor: Intel 80188

Data entry: Discrete key switches

Data sampling rate: 100 Hz

Operating temperature range: 10-40 °C (50-104 degrees F)

Operating voltage range: 110V AC, 220V AC or 240V AC all ±15%

Operating frequency range: 50-60Hz

Power supply output: Nominal 10V DC

Size Net Gross:

300 x 250 x 130mm 560 x 390 x 210mm

Weight Net Gross:

3.9KG 5.9KG

Vitalograph have a policy of continuous improvement, and reserve the right to change the above specification without notice.


APPENDIX A: CIRCUIT DIAGRAM


APPENDIX B: FUNCTIONAL BLOCK DIAGRAM


APPENDIX C: FAULT FINDING GUIDE The following fault finding guide suggests possible reasons for difficulty being experienced. Problem Fault Symptoms: Calibration Drift > +/-3%.

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

Possible Causes (In probable order):

• An Accuracy Check is required after Cleaning/Disinfecting the flowhead or after Disassembly/Re-assembly.

• Flowhead Connection Tube has a pin-hole or is not correctly connected.

• Flowhead Cone Fleisch Element Flow conditioning mesh missing or blocked.

• Flowhead Fleisch Element Body Pressure Port holes blocked.

• Flowhead Fleisch Element Assembly sealing or ‘O’ rings damaged.

• Flowhead Fleisch Element Assembly not dried thoroughly – small holes blocked.

• Flowhead Fleisch Element small holes blocked with lung debris.

• Main PCB failure.

Problem Fault Symptoms: Blank screen display on power up.


• Check if Cartridge is fully inserted • Check Contrast Control adjustment • Check Power Supply connections to Vitalograph ALPHA and

to mains supply • Check PowerSAFE 10V adapter or mains lead by

substitution. • Check Main PCB to Display ribbon cable connections • Check Main PCB by substitution. • Check Display ribbon cable by substitution. • Check Display by substitution

Problem Fault Symptoms: Printer not working properly


• Check that the printer paper is inserted correct side up - as detailed in the User manual.

• Check Printer PCB to Main PCB connection. • Check Printer PCB by substitution. • Check Main PCB by substitution.

Problem Fault Symptoms: Test begins automatically

Volume accumulates for 20s without the subject blowing Very small VC or FVC test displayed


• 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: Last entered DATE corrupted on 'Power On'

Obviously false test readings


Internal EEPROM corrupted. Re-enter the correct date and re-calibrate the instrument.

Problem Fault Symptoms: Keys not operating or sticking Possible Causes (In probable order):

Cable incorrectly fitted - refit cables Faulty Keypad - replace (KEYPAD COMPETE - AL3 part no 61040)


APPENDIX D: SAMPLE RISK ASSESSMENT

Date 17/9/02 Task Use Vitalograph Alpha

Hazard Infection

1. Circle level of risk assessed in each of the 4 “value” columns

Probability of Exposure to Hazard *

PE value

Frequency of Exposure to Hazard

FE value

Maximum Probable Loss * (work related)

MPL value

No. of Persons @ Risk

NP value

Impossible 0 Rarely 0.1 Scratch/bruise/ache 0.1 1-2 1 Unlikely 1 Annually 0.2 Broken Skin/ Strain 0.5 3-7 2 Possible 2 Monthly 1 Minor Illness/ Injury 1 8-15 4

Even chance 5 Weekly 1.5 Major Illness/ Injury 2 16-50 8 Probable 8 Daily 2.5 Temp. Maj. Illness/

Injury 4 50> 12

Likely 10 Hourly 4 Perm. Maj. Illness/ Injury

8

Certain 15 Constantly 5 Fatality 15 * For guidance see Definitions page

1 X 0.1 X 4 X 1 = 0.4 2. Calculate Hazard Rating Number (HRN) using the following equation

HRN = PE x FE x MPL x NP Hazard Rating Number = Probability of exposure x Frequency of exposure x Maximum probable loss x No. People

* Use chart opposite to interpret results

3. Plan remedial action and review periodically until completed. Recommended Action To Reduce Risk: To be actioned by: Completion

date:

Signed………………………… Designation……… Date.………..


DEFINITIONS

PE = Probability of Exposure Impossible Cannot happen under any circumstance Unlikely Though Conceivable Possible But Unusual Even chance Could Happen Probable Not Surprised Likely Only to be expected Certain No doubt

MPL = Maximum Probable Loss Scratch/Bruise/Ache Superficial Wounds Puncture Wound/Broken Skin Penetrating Wounds – sharps/major cuts Minor Illness/ Injury Does not require in-patient treatment: minor fracture

(toe/finger), substance reaction, burn, scald, and infection.

Major Illness/ Injury Requiring in-patient treatment: major fracture (limb, skull, spine), reaction, burn, infection

Temp. Major Illness/Injury Unable to continue in present work or results in long-term sickness. (loss of limb, eye, back mobility, serious treatable illness, substance sensitisation)

Perm. Major Illness/Injury Unable to continue employment of any kind (loss of limbs, eyes, back mobility, serious untreatable illness, severe substance sensitisation)

Fatality Self Explanatory

HRN Risk Act to reduce HRN 0-1 Acceptable Accept Risk 2-5 Very Low Within 1 year 6-10 Low Within 3 months 11-50 Significant Within 1 month 51-99 High Within 1 week 100-499 Very High Within 1 day 500-999 Extreme Immediately >1000 Unacceptable Stop Activity until risk is lowered

There is an extremely low risk of serious, but treatable infection. The hazard rating number of 0.4 is well within the acceptability range

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