Alpha 3 - 081052
Alpha 3 - 081052
Alpha 3 - 081052
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
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
Figure 2 : Checking Accuracy of the Vitalograph ALPHA 4. 5. 6. The user is prompted to confirm or enter the ambient temperature when the accuracy check routine is initiated. THIS MUST BE MEASURED ACCURATELY. Follow the on-screen instructions until prompted to pump air through the flowhead. Ensure that the syringe piston is withdrawn fully before starting. 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. 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. 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..
7.
8.
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,
Copyright Vitalograph 2000, 2003 081052 Issue 7
spirometer and syringe before considering adjusting the calibration setting. 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 reentering 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.
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 users 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.
Material
Polystyrene High Density foam with epoxy paint Glass ABS ABS Silicone Rubber Aluminium, Stainless Steel Aluminium & Acetyl TPX TPX Acetyl and Polyester
Clean/ Disinfect
Clean Clean Clean Clean Clean Clean Clean & Disinfect Clean & Disinfect Clean & Disinfect Disinfect Dispose
Autoclave
No No No No Viable Viable No Viable Viable No
Recommended Disinfectants
Wiping with a 70% Isopropyl Alcohol impregnated cloth provides a suitable form of cleaning and low-level disinfection. This may be preceded by cleaning with an antistatic foam cleaner if necessary. Disinfect by immersion in sodium dichloroisocyanurate solution at 1000 ppm concentration of free chlorine for 15 minutes. (see below for recommended cleaning/disinfection method for the Vitalograph Alpha Flowhead) The flowhead may also be disinfected by autoclaving at 134C 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.
Copyright Vitalograph 2000, 2003 081052 Issue 7
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. 2. 3. 4. 5. 6. 7. 8.
Flowhead Complete - 61030 'O' rings - 2120013 Flowhead End Cap - 62006SPR Flow Conditioning Mesh - 42084 Flowhead Cone - 62019SPR Fleisch Element Assembly - 62055SPR Flowhead Body 61020 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 manufacturers 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.
4. 5. 6.
7. 8.
9.
Push the FLOWHEAD END CAP onto the larger diameter of the FLEISCH ELEMENT ASSEMBLY and push the FLOWHEAD CONE onto the smaller diameter. 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. It is recommended that an accuracy check is carried out following reassembly to verify correct operation and accuracy.
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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
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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
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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.
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.
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REPLACING PARTS
THE FITTING OF ANY SPARE PARTS SHOULD BE CARRIED OUT BY TRAINED AND QUALIFIED SERVICE TECHNICIANS ONLY.
1. Keypad Complete -61040 2. LCD Display - 60023SPR 3. Printer with Board - 61024
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5 4
3 2
1
Figure 6 : Internal view - Bottom Half Parts Identification
1. 2.
Main PCB Service Exchange - 61023 Contrast Control with knob - 31583SPR 15
3. 4. 5.
On/Off Switch - 31639SPR Pressure Inlet Ports - 60039SPR Power Inlet Socket - 31625SPR
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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.
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Planned Preventive Maintenance Service Serial No: Vitalograph ALPHA III Service Schedule
ACCURACY CHECK RECORD Pre-Service Reference Volume Volume Recorded Difference L L _____% ACCURACY CHECK RECORD Post-Service Reference Volume Volume Recorded Difference L L _____%
FLOWHEAD AND TUBING* Replace element, O rings, cone, meshes & twintubing Spray & Bag element & O rings; Dispose Cone, meshes & tubing Check pressure tappings flowhead / instrument ELECTRICAL SAFETY TESTING Check suitable mains plug - fused? Mains Cable Outer Sheath & IEC Connector PowerSAFE: Casing/cable/jackplug/output voltage ELECTRONICS & FIRMWARE Check Version/Issue of Software General Damage Check Inspect LCD Glass & Display Check LCD Contrast Check Print Quality Check Operation of Keypad - 12 Buttons Check Internal Leads & Connections Check internal fuse rating Check PCB Input Voltage (9.5-10.5V) Internal Power Supplies: +5V; Prt +5; +10; -10; -12 Check Contrast Potentiometer Ensure all screws & Fasteners are locked SPECIAL ADVICE TO USER:
NOTE HERE IF SPIROMETER PRE-SERVICE ACCURACY CHECK OUT OF TOLERANCE Previous Measurements were out by _____% OverUnder- Reading (delete as applicable) CLEANING & HYGIENE Clean Print Head & Brush clean Print Rollers Air dust PCB & all internals Clean & Disinfect outer casing, PowerSAFE & Lead Check all breathing circuit components replaced CALIBRATION & FUNCTIONAL TEST Adjust Calibration for new flowhead Perform VC & FVC test Procedure using syringe Final Accuracy check and print (Leave in Printer) Apply Clinically Clean Label RECORD KEEPING Issue Calibration Certificate for Spirometer Issue Calibration Certificate for Precision Syringe Affix Next Service due label to Spirometer Complete Service Records Customers Signature
Software Upissued YES/NO User Advised YES/NO * Items are not part of the interim service
Service Technician:
Name:
I hereby Certify this instrumentation to be safe, clinically clean and in proper working order. Calibration of Spirometer & Syringe Certified as above. Date:
Signature:
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Spare Parts
30961SPR 31297SPR 31375SPR 31376SPR 31583SPR 31625SPR 42028SPR 42029SPR 44011SPR 44015SPR 44048SPR 60023SPR 60039SPR 61018 61019 61020 61023 61024 61030 61039 61040 62006SPR 62019SPR 62055SPR 21001204 2120013 61051 Silicone Grease 3 Pin Mains Power Cable with 5A fuse (UK) 2 Pin Mains Power Cable (USA) 2 Pin Mains Power Cable (International) Contrast Control with Knob Power inlet Socket Flowhead Retaining Strap Flowhead Connection Tube LCD Display Glass Paper Roller Vitalograph ALPHA Carrying Case ALPHA Display Pressure Inlet Ports Paper Roll Clip Paper Tear Bar Flowhead Body Main PCB ALPHA III S/X PCB & Printer ALPHA III S/X Flowhead Complete LCD Surround Keypad Complete Flowhead End Cap Flowhead Cone Fleisch Element Assembly Standard PowerSAFE 'O' rings 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.
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TECHNICAL SPECIFICATIONS
Flow detection principle: Volume measurement: Accuracy better than: Fleisch type Pneumotachograph Flow integration Volume 3% or 0.05L whichever is greater, Flow 5% or 0.2L/s whichever is greater(Inspiratory: 5% vol., 8% flow) American Thoracic Society 1994 CE Mark - MDD 93/42/EEC EN60601-1 & -2 8 Litres 16 Litres/sec 20-s FVC / 20-s VC 0.044kPa/L/s (0.45cm H2O) at 14 L/s Thermally sensitive 112mm wide (coating inside) 36 lines per minute 42 max. LCD graphics panel 240x64 pixels Intel 80188 Discrete key switches 100 Hz 10-40 C (50-104 degrees F) 110V AC, 220V AC or 240V AC all 15% 50-60Hz Nominal 10V DC 300 x 250 x 130mm 560 x 390 x 210mm 3.9KG 5.9KG
Certified Performance Standard: Certified Safety Standard: Max. displayed volume: Max. displayed flow rate: Max. test duration: Back pressure: Printing paper: Printer speed: Characters per line: Display: Microprocessor: Data entry: Data sampling rate: Operating temperature range: Operating voltage range: Operating frequency range: Power supply output: Size Net Gross: Weight Net Gross:
Vitalograph have a policy of continuous improvement, and reserve the right to change the above specification without notice.
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Problem Fault Symptoms: Possible Causes (In probable order): Problem Fault Symptoms: Possible Causes (In probable order):
Last entered DATE corrupted on 'Power On' Obviously false test readings Internal EEPROM corrupted. Re-enter the correct date and recalibrate the instrument. Keys not operating or sticking Cable incorrectly fitted - refit cables Faulty Keypad - replace (KEYPAD COMPETE - AL3 part no 61040)
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Hazard Infection
Probability of Exposure to Hazard * Impossible Unlikely Possible Even chance Probable Likely Certain
1. Circle level of risk assessed in each of the 4 value columns Maximum Probable No. of PE Frequency MPL FE
value
of Exposure to Hazard
value
Loss * (work related) Scratch/bruise/ache Broken Skin/ Strain Minor Illness/ Injury Major Illness/ Injury Temp. Maj. Illness/ Injury Perm. Maj. Illness/ Injury Fatality
value
Persons @ Risk
NP
value
0 1 2 5 8 10 15
0.1 0.5 1 2 4 8 15
1 2 4 8 12
1 X 0.1 X 4 X 1 = 0.4
* 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...
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DEFINITIONS
PE = Probability of Exposure
Impossible Unlikely Possible Even chance Probable Likely Certain Scratch/Bruise/Ache
Puncture Wound/Broken Skin Minor Illness/ Injury Major Illness/ Injury Temp. Major Illness/Injury
Cannot happen under any circumstance Though Conceivable But Unusual Could Happen Not Surprised Only to be expected No doubt Superficial Wounds
Penetrating Wounds sharps/major cuts
Does not require in-patient treatment: minor fracture (toe/finger), substance reaction, burn, scald, and infection. Requiring in-patient treatment: major fracture (limb, skull, spine), reaction, burn, infection Unable to continue in present work or results in long-term sickness. (loss of limb, eye, back mobility, serious treatable illness, substance sensitisation) Unable to continue employment of any kind (loss of limbs, eyes, back mobility, serious untreatable illness, severe substance sensitisation)
Fatality
Self Explanatory
HRN
Risk
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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