Vitalograph!

VITALOGRAPH
MODEL 6300
SERVICE MANUAL

micro

CERTIFIED UNDER THE MEDICAL DEVICES DIRECTIVE

Vitalograph Ltd., Maids Moreton, Buckingham, MK18 1SW, England Phone: (01280) 827110 Fax: (01280) 823302 e-mail: sales@vitalograph.co.uk Vitalograph GmbH, Jacobsenweg 12, 22525 Hamburg, Germany Phone: (040) 54 73 91-0 Fax: (040) 547 391- 40 e-mail: info@vitalograph.de Vitalograph Inc., 13310 West 99 St, Lenexa, Kansas 66215, U.S.A. Phone: (913) 888-4221 Fax: (913) 888-4259 e-mail: vitcs@vitalograph.com Vitalograph (Ireland) Ltd., Gort Road Business Park, Ennis, Co. Clare, Ireland Phone: +353 (0)65 6864100 Fax: +353 (0)65 6829289 e-mail: sales@vitalograph.ie
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www.vitalograph.com
Copyright Vitalograph 1999, 2003, 2005 Current Edition (Issue 3) Service Manual Cat. No. 07060

Vitalograph is a registered trademark.

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Table Of Contents
CHAPTER 1: INTRODUCTION........................................................................................................................................ 4 Vitalograph micro Display............................................................................................................................................... 5 Vitalograph micro Label.................................................................................................................................................. 5 CHAPTER 2: PRINCIPLE OF OPERATION..................................................................................................................... 6 CHAPTER 3: COMMISSIONING AND START-UP OF THE INSTRUMENT .................................................................. 7 Setting Up....................................................................................................................................................................... 7 To conduct a spirometry measurement:......................................................................................................................... 8 PRINTING TO THE PC UTILITY....................................................................................................................................... 8 CHAPTER 4: ACCURACY CHECK & CALIBRATION ..................................................................................................... 9 Accuracy Check ............................................................................................................................................................. 9 Calibration Adjustment ................................................................................................................................................. 10 Sample Accuracy Check History Log Sheet................................................................................................................. 11 CHAPTER 5: FUNCTIONAL CHECK ............................................................................................................................. 12 CHAPTER 6: CLEANING AND DISINFECTING............................................................................................................. 13 General Recommendation ........................................................................................................................................... 13 Routine Practice ........................................................................................................................................................... 13 Cleaning Instructions.................................................................................................................................................... 13 Cleaning/Disinfecting- Recommendations Chart ......................................................................................................... 13 Disassembling for Cleaning and Disinfecting............................................................................................................... 14 Reassembling the Fleisch Flowhead............................................................................................................................ 14 CHAPTER 7: TECHNICAL SPECIFICATIONS............................................................................................................... 15 CHAPTER 8: SERVICE SHEET..................................................................................................................................... 16 APPENDIX A: CIRCUIT DIAGRAM ................................................................................................................................ 17 APPENDIX B: FUNCTIONAL BLOCK DIAGRAM.......................................................................................................... 18 CUSTOMER SERVICE.................................................................................................................................................... 19

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CHAPTER 1: INTRODUCTION
The Vitalograph micro is a portable and easy to use precision spirometer. It offers total confidence in rapid and accurate spirometry measurements as a part of your routine physical examination. The Vitalograph micros features include: Flow detection principle Fleisch type pneumotachometer, No. 2 size single breath calculation of a range of both expiratory and inspiratory parameters displays FVC, FEV1, FEV1% and PEF after each manoeuvre prints predicted values, results and graphs prints suggested interpretation small pocket size and light weight easy to use large, clear display on screen battery low indicator auto switch off after 2 minutes of no use long term stability with no moving parts flowhead, clips in and out for easy cleaning accuracy checking facility patented SafeTway mouthpiece for complete hygiene

The Vitalograph micro Service Manual should be used in conjunction with the Vitalograph micro User Manual (07056).

Flowhead Down Arrow Button Flowhead Release Button Up Arrow Button LCD Display (see below)

Top Recess Button

Enter Button

On/Off Button

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Vitalograph micro Display

Displays digits and segments Displays test parameters

Displays units

Displayed during power on

Blow Now Symbol, indicates the unit is ready to do a test

Thumbs Up/Down Symbol, indicates successful/unsuccessful accuracy check/calibration update

Low Battery Symbol (see table below)

Vitalograph micro Label

Weight Gender Age

Height

Symbol (on or flashing)

Condition Battery Low

Result You can perform test

Action Replace PP3 battery

Battery Nearly Dead

You cannot perform test

Replace PP3 battery

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CHAPTER 2: PRINCIPLE OF OPERATION

The Vitalograph micro measures a subjects lung ventilation by using a flowhead containing a small Fleisch-type Pneumotachograph capable of giving linear signals throughout the entire physiological range. During testing, the airflow through the Pneumotach produces a very low-pressure differential. Internally this pressure is applied to a pressure transducer, which produces an electric signal. This signal is converted into digital form so that the unit can perform calculations and the results be displayed. The following lung function parameters are displayed on the printout: FVC FEV1 FEV1 / FVC FEV6 PEF FEF25 FEF75 FEF25 75 Note: The display is always the last blow, but the printout will be the automatically selected best test (using ATS/ERS:2005 criteria) from any number in a series. The Vitalograph micro retains last best-test even when switched off (not overwritten until a blow occurs after switch-on) The following graphs are displayed on the printout:

Flow-Volume graph Volume-Time graph

Note: If an inspiratory section of the flow-volume graph is printed, this is only an indication that an Inspiratory test has occurred and does not accurately represent the volume inspired.

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CHAPTER 3: COMMISSIONING AND START-UP OF THE INSTRUMENT

The Vitalograph micro is not supplied with its power source (9V PP3 type alkaline battery - recommended capacity of at least 550mAh). The battery should be fitted by attaching it to the connector in the battery compartment and locating the battery in the slot provided. It is necessary to feed the excess connector cable back into the hole from which it exits to ensure that the battery fits correctly. When the battery is fitted, the unit will power up immediately. Note that it is recommended to remove the battery if you do not intend using the Vitalograph micro for several weeks.

Setting Up
Follow these instructions in sequence to set up the Vitalograph micro before you use it for the first time, or to change settings later.

Step1: Entering configuration mode

. 1. Press Note that the Vitalograph micro turns itself off if not used within two minutes.

2. Press

repeatedly until the time is displayed at the same time.

3. Press the top recess button and Step 2: Set Units 1. Press

to change Thumbs Up/Down symbol. means US format for date, means European format

2. Press

to continue

Step 3: Set the Time

1. To select the correct hour press quickly. 2. Press 3. To select the correct minute press 4. Press or . or . Note that pressing down continuously on the button changes the number

Step 4: Set the Date

1. To select the correct year press 2. Press 3. To select the correct month press 4. Press
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or

or

5. To select the correct day press 6. Press

or

to return to finish. Time and blow icon are displayed.

To conduct a spirometry measurement:

The user is required to enter subject demographics by scrolling the number on the screen in the following sequence height (cm), age (years), sex (Male 0; Female 1) and weight (kg). After completion of the above, the Vitalograph micro is ready for testing. The time and the blow now icon appears on the screen, accompanied by a double beep. The display shows the last test, but the best test is held in memory. Blows may be repeated when the blow icon is showing. On completion of testing the user can attach a printer and print the current session. The best test in the session will be printed.

PRINTING TO THE PC UTILITY

The PC Utility enables printing of a PDF file and/or to your PC Printer, follow the steps below: Immediately after a test session is completed, plug the jack plug into the Vitalograph micro jack socket, which is located on the side of the device. Press Press or on the Vitalograph micro until the following screen is displayed.

. The screen should immediately go blank.

The Vitalograph micro will take about two minutes to download all the test data during which time it should not be interfered with. After two minutes transmission, the device will beep and briefly display PRN again. At this time the creation of the spirometry report begins in the PC Print Utility. Depending on your settings, a PDF will be created and/or a print command will be sent to your designated printer .
1

Note: The best test in the session is printed, not necessarily the last test which is still showing on the LCD screen.
To cancel at any time press and hold the switch for 15 seconds approx.

Figure 1 Vitalograph Print Utility Product Perspective

If you installed the Print Utility with default settings, no print command will be sent but a PDF file will be created in the following location: C:\Program Files\Vitalograph\VitalPrint\Data
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Note: When the Vitalograph micro switches itself off, the best test from the last session is retained until the next blow. This stored test may be printed at any time as long as no new blow is detected by the device. Switch ON, press Enter repeatedly until the Blow Icon and time are displayed, then press and together to print.

CHAPTER 4: ACCURACY CHECK & CALIBRATION

Accuracy Check
Your Vitalograph micro is extremely stable and needs no calibration adjustment between the annual service intervals. However, international guidelines such as ATS/ERS recommend that the accuracy of spirometers be checked at least daily using a 3-L Precision Syringe. The Vitalograph micro can be checked for accuracy easily using the following procedure, using a 3-L Precision Syringe. Ensure that the syringe has been in the same temperature environment as the unit for at least an hour.

1.

After switching the unit on, press the upper recess / Accuracy Check button with a suitably pointed object. The display will look like ..

2.

Press Up and Down to change the syringe stroke volume if you are not using a 3-L syringe. The 03 represents the stroke volume of your precision syringe, not the total volume that will be delivered. It is very important to set this up correctly, otherwise, the accuracy check will not function properly. Press Enter. The display will look like .

3.

4. 5. 6. 7.

Ensure the syringe piston is fully withdrawn. At this point, connect the Vitalograph micro to the syringe using the adaptor supplied. Leave the Vitalograph micro in a stable position - do not move the unit during this procedure. With an even stroke, pump the air from the syringe through the device. The stroke must be at least one second in duration. Wait for a double beep, withdraw the syringe piston fully and repeat step 5 several times until five beeps occur in rapid succession. It is very important to wait for the double beep before withdrawing the piston each time. If there is a Thumbs Up on the LCD, then the unit is within the +/- 3% accuracy tolerance

Note: with reference to step 6 above, the user will be prompted by means of a double beep for another stroke of the syringe when the volume difference of the present stroke is not within 3% of the previous stroke. If the maximum of five strokes is executed, then the five beeps will occur, signifying the end of the accuracy check. 1. End Of Procedure If there is a Thumbs Down on the LCD, then the unit is outside the +/- 3% accuracy requirements. Check for faulty assembly or procedure, then recheck accuracy. If still wrong contact Technical Support.

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Calibration Adjustment
It is very unlikely that calibration will be outside tolerance unless there is some damage to the device or there is a fault. Please carefully inspect the unit and re-check accuracy before adjusting calibration. IMPORTANT: If your Vitalograph micro has a current Certificate of Calibration Traceability, entering the calibration adjustment procedure will invalidate this certificate. Any applied calibration traceability stickers should also be removed. The calibration of the Vitalograph micro can be adjusted easily using the following procedure. A 3-L precision syringe is recommended. 1. After switching the unit on, press the Calibration Adjust / lower recess button with a suitably pointed object. The display will look like

2. 3.

Press Up and Down only if your Precision Syringe is NOT a 3-L stroke volume. It is very important to set this to the stroke volume of the syringe otherwise the calibration adjustment procedure will not function properly. Press Enter. The display will look like

4. 5. 6. 7.

Ensure the syringe piston is fully withdrawn. At this point, connect the unit to the syringe and leave it in a stable position - do not move the unit during this procedure. With an even stroke, pump the air from the syringe into the unit. The stroke must be at least one second in duration. Wait for a double beep, withdraw the syringe piston fully and repeat step 5 until five beeps occurs. It is very important to wait for the double beep before withdrawing the piston each time. If there is a Thumbs Up on the LCD, then the unit has adjusted its calibration successfully..

8.

If there is a Thumbs Down on the LCD, then a problem was encountered while trying to adjust calibration.

If this happens, refer to the Troubleshooting section or contact Technical Suppport. 9. Turn the unit off.

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Sample Accuracy Check History Log Sheet

Use a 1-L or a 3-L Precision Syringe to check your instrument, 3-L is recommended. Ensure that your spirometer and precision syringe are left in the same temperature environment for approximately 1 hour. Do not adjust calibration unless it falls outside the limits for the reference volume used, refer to product user manual for calibration limits. If calibration is adjusted, recheck accuracy and note findings in the REMARKS column.

When to check accuracy? In accordance with your own established procedures/international guidelines. After annual maintenance service. After cleaning or disassembling spirometer for any reason. After adjusting calibration. SERIAL # YOUR UNITS ACCURACY CHECK HISTORY LOG DATE TEMP C PRECISION SYRINGE SERIAL NO ACCURACY CHECK RESULT OPERATOR INITIALS REMARKS

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CHAPTER 5: FUNCTIONAL CHECK

In order to determine whether the Vitalograph micro is functioning correctly the following steps should be carried out: 1. 2. 3. 4. Turn on the unit; scroll to a height of 0 and press Enter. This will allow you to get to the ready screen without having to enter all the demographic data. The time and the Blow symbol should appear after a few seconds. Use a syringe to blow air through the flowhead. Check that a volume registers. (It may not be the same as the displaced volume because BTPS correction will be applied in test mode. If this seems to function properly, perform an accuracy check as detailed in Section E Accuracy Check & Calibration.

Fault condition: If the instrument is faulty, contact your Vitalograph service centre for advice, service or repair.

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CHAPTER 6: CLEANING AND DISINFECTING

General Recommendation
To reduce the risk of cross infection the use of SafeTway mouthpieces 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. 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 micro 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.

Routine Practice
A new mouthpiece (SafeTway mouthpiece) should be used for each subject. A period of at least 5 minutes should be allowed between subjects to allow settling of aerosolised particles. 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 - it should be cleaned and disinfected or replaced. It should also be replaced in the event of damage. It is recommended to replace the complete: FLOWHEAD as a part of the routine annual service. All parts of the Vitalograph micro require cleaning, i.e. the removal of visible particulate contamination. The parts of the Vitalograph micro that make up the flowhead also require disinfecting. HYGIENE It is vital for the user to set guidelines for protective hygiene measures whilst performing spirometry testing. There are three main potential sources of cross contamination, skin contact; aerosolised particles and saliva/body fluids. By far the most important is the last item a minimum requirement is to use a new disposable mouthpiece for each subject tested. We recommend using the SafeTway mouthpiece. We also recommend that a period of at least 5 minutes be allowed between subjects. This allows aerosolised organisms to be removed by gravitational sedimentation between tests. (Am J Respir Crit Care Med Vol 159. pp 610-612, 1999)

Cleaning Instructions
All parts of the Vitalograph micro require regular cleaning, i.e. the removal of visible particulate contamination. The parts of the Vitalograph micro that make up the flowhead also require disinfecting. Vitalograph recommends that cleaning and disinfecting should normally be carried out on a weekly basis. In addition to a weekly cleaning and disinfection cycle, Vitalograph recommends cleaning and disinfection of equipment to be carried out after use on infected subjects or prior to use on immuno-compromised subjects. The user must determine what level of disinfection is appropriate and acceptable in any particular circumstance. Cleaning/Disinfecting- Recommendations Chart

Part
Case Exterior

Material ABS

Clean/ Disinfect Clean

Autoclave Possible? No

Recommended Disinfectants
Wiping with a 70% Isopropyl Alcohol impregnated cloth provides a suitable form of cleaning and low-level disinfection. Do not immerse in liquid.

Display Keypad Fleisch No2 Flowhead

Glass Rubber Aluminium, Stainless Steel, ABS

Clean Clean Clean & Disinfect

No No Yes

Hydrophilic filters

Polyethylene

Replace every year or after water ingress.

No

Disinfect by immersion in sodium dichloroisocyanurate solution at 1000 ppm concentration of free chlorine for 15 minutes. Dispose

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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 for Cleaning and Disinfecting 1. Press in the two round flowhead release buttons. 2. Lift off the flowhead. Clean the flowhead by washing in a mild detergent to remove particulate contamination. To clean the Fleisch element, swill vigorously in water with mild detergent. Do not attempt to rub or scrub at capillaries. If the flow conditioning meshes appear dirty or blocked the flowhead should be replaced. Rinse with clean water. Disinfect by immersion in sodium dichloroisocyanurate 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. Wiping with a 70% Isopropyl Alcohol impregnated cloth provides a suitable form of cleaning and low-level disinfection for the case exterior, display, screen, and keypad. Repeat at least weekly to prevent build-up of grime from normal handling and use. Always follow the safety guidelines given by the manufacturer of cleaning and disinfectant chemicals or equipment.

Flowhead Hydrophilic Filters Flowhead release button

Reassembling the Fleisch Flowhead 1. Ensure that the hydrophilic filters are undamaged and dry. 2. 3. 4. Orient the two circular holes under the flowhead with the hydrophilic filters in the body. Push the flowhead onto the body, making sure that the two buttons click into place. It is advisable to check accuracy and perform a functional check after cleaning and disinfecting.

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CHAPTER 7: TECHNICAL SPECIFICATIONS

Symbols Class II Equipment Type BF Equipment 9V, PP3 Battery type - 9V PP3 Flow detection principle Flow Impedence Volume measurement Maximum recorded flow rate Maximum recorded volume Measuring accuracy Test duration Operating temperature Safety standards Radio Frequency Emissions Spirometric standards Power supply Unit dimensions Unit weight Storage Fleisch type pneumotachometer No 2 size Meets ATS / ERS Guidelines Flow integration 999 L/Min 9.99 Litres +/- 3% or +/-0.05L volume whichever is greater and +/-10% flow or +/-20L/Min whichever is greater 30 seconds maximum 15-37 C Certified to conform to ISO / EN60601-1 Certified to conform to ISO / EN 60601-2 ATS / ERS Alkaline battery, 9V, PP3 (MN1604) (Recommended battery capacity = 550 mAh or greater) 145mm x 70mm x 87mm 165g (without PP3 battery) Temperature : 0-50C Relative Humidity : 10%-95%

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CHAPTER 8: SERVICE SHEET

Planned Preventive Maintenance Service

Vitalograph micro Service Schedule
ACCURACY CHECK RECORD Pre-Service Reference Volume Volume Recorded Difference FLOWHEAD AND TUBING* Replace Flowhead Replace Hydrophilic filters Dispose Flowhead and filters Check pressure tappings flowhead / instrument ELECTRICAL SAFETY TESTING General Damage Check Check battery connectors for damage Replace Battery* ELECTRONICS & FIRMWARE Check Version/Issue of Software Inspect LCD Glass & Display Check Contrast of LCD Check Operation of Keypad - 6 Buttons Ensure all screws & Fasteners are locked SPECIAL ADVICE TO USER: CALIBRATION & FUNCTIONAL TEST Perform FVC test Procedure using syringe Adjust Calibration for new flowhead Final Accuracy check Apply Clinically Clean Label RECORD KEEPING Issue Calibration Traceability Certificate Calibration Traceability Certificate Precision Syringe Affix Next Service due label to Spirometer Complete Service Records Customers Signature PRECISION SYRINGE CERTIFICATION* Customers Syringe S/No: Nominal Volume Check Capacity: Adjust if necessary Check general condition Traceable Tool (T5-36075) Serial No Complete and Affix Calibration Label to Syringe Software Upissued YES/NO User Advised YES/NO * Items are not part of the interim service Technicians Syringe Used - Serial No: L (ring) YES/NO 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 Previous Measurements were out by OverCLEANING & HYGIENE Air dust PCB & all internals Clean & Disinfect outer casing Check all breathing circuit components replaced _____% Under- Reading (delete as applicable)

Vitalograph Trained 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.

Signature:

Date:

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APPENDIX A: CIRCUIT DIAGRAM

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APPENDIX B: FUNCTIONAL BLOCK DIAGRAM

Flow Sensor Random Access Memory

REAL TIME

PRESSURE

EEPROM

Transduc er
Micro Processor

Clock

9V PP3 BATTERY

with 64K Read Only Memory. Keypad

CUSTOMISED LIQUID SERIAL PORT BUZZER

Crystal Display

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CUSTOMER SERVICE
Servicing of the Vitalograph micro should be carried out only by qualified service technicians. For the names and addresses of approved Vitalograph Service Agents, please contact any of the following offices or your local Vitalograph distributor.

Vitalograph Ltd., Maids Moreton, Buckingham, MK18 1SW, England Phone: (01280) 827110 Fax: (01280) 823302 e-mail: sales@vitalograph.co.uk Vitalograph GmbH, Jacobsenweg 12, 22525 Hamburg, Germany Phone: (040) 54 73 91-0 Fax: (040) 547 391 40 e-mail: info@vitalograph.de Vitalograph Inc., 13310 West 99 St, Lenexa, Kansas 66215, U.S.A. Phone: (913) 888-4221 Fax: (913) 888-4259 e-mail: vitcs@vitalograph.com Vitalograph (Irl.) Ltd, Gort Road Business Park, Ennis, Co. Clare, Ireland Phone: (065) 6829611 Fax: (065) 6829289 e-mail: sales@vitalograph.ie Internet: www.vitalograph.com
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