ALPHA

Model 6000

User Training Manual

Vitalograph Ltd. UK
Maids Moreton, Buckingham,
MK18 1SW
England
Tel: (01280) 827110
Fax: (01280) 823302
E-mail: sales@vitalograph.co.uk
www.vitalograph.co.uk

Vitalograph Ltd. International
Maids Moreton, Buckingham,
MK18 1SW
England
Tel: +44 1280 827120
Fax: +44 1280 823302
E-mail: sales@vitalograph.co.uk
www.vitalograph.eu

Vitalograph GmbH
Rellinger Straße 64a,
D-20257 Hamburg,
Germany
Tel: +49 40 547391-0
Fax: +49 40 547391-40
E-mail: info@vitalograph.de
www.vitalograph.de

Vitalograph Inc.
13310 West 99th Street,
Lenexa, Kansas, 66215,
USA
Toll Free: 800 255 6626
Tel: (913) 730 3200
Fax: (913) 730 3232
E-mail: vitcs@vitalograph.com
www.vitalograph.com

Vitalograph (Ireland) Ltd.
Gort Road Business Park,
Ennis, Co. Clare,
Ireland
Phone: +353 65 6864100
Fax: : +353 65 6829289
e-mail: sales@vitalograph.ie
www.vitalograph.ie

Vitalograph Ltd. Hong Kong /China
Unit 2001, Floor 20, Block A,
New Trade Plaza, 6 On Ping Street,
Shatin
Hong Kong
Phone: +852 2117 2678
Fax: : +852 2117 2679
E-mail: sales@vitalograph.cn
www.vitalograph.cn

© Copyright Vitalograph 2013
Current Edition (Issue 11)
Cat. No. 07368

is a registered trademark

Table of Contents

1. DESCRIPTION OF THE VITALOGRAPH ALPHA
1. INDICATIONS FOR USE
2. CONTRAINDICATIONS AND PRECAUTIONS FOR USE
   
2. MAIN COMPONENTS OF THE VITALOGRAPH ALPHA
3. FEATURES OF THE VITALOGRAPH ALPHA
4. GETTING THE VITALOGRAPH ALPHA READY FOR USE
5. POWER MANAGEMENT IN THE VITALOGRAPH ALPHA
1. BATTERY PACK
2. BATTERY LOW DETECT
   
6. OPERATING THE VITALOGRAPH ALPHA
   1. ENTERING SUBJECT INFORMATION
   2. PERFORMING A TEST SESSION
      1. Checks to Make before Performing a Test Session
      2. Performing a VC Test
      3. Performing an FVC Test
   3. SAVING THE TEST SESSION
   4. PERFORMING A POST TEST SESSION
   5. PRINTING THE TEST SESSION
   6. CLEAR RESULTS
   7. CHECKING ACCURACY
      1. When to Check Accuracy
   8. VIEWING CURRENT SUBJECT DETAILS
   9. DELETING STORED SUBJECTS/TEST RESULTS
   10. CONFIGURATION OPTIONS
       1. Preferences
       2. Date/Time
       3. Report Settings
       4. Syringe/Calibration
       5. Sound Volume
   11. FITTING A NEW PAPER ROLL
7. CLEANING INSTRUCTIONS
   1. CLEANING AND DISINFECTING THE VITALOGRAPH ALPHA
   2. DISASSEMBLING THE FLEISCH FLOWHEAD
   3. REASSEMBLING THE FLEISCH FLOWHEAD
8. FAULT FINDING GUIDE
9. CUSTOMER SERVICE
10. CONSUMABLES AND ACCESSORIES
11. EXPLANATION OF SYMBOLS
12. TECHNICAL SPECIFICATIONS
13. CE NOTICE
14. FDA NOTICE
15. DECLARATION OF CONFORMITY
16. GUARANTEE

Figure 1

1. Description of the Vitalograph ALPHA

The Vitalograph ALPHA is a desktop spirometer designed for use by trained professionals in the doctor’s office, clinic, hospital department, etc. for measuring and archiving tests on human subjects. Demographic data are uploaded or entered via a keypad and stored, together with spirometry test data. Current test data can be viewed on the LCD and printed and downloaded to a PC. There are a variety of backup and other configuration options.

Information about the software can be obtained from the About box. This information can be used if any queries are made to Vitalograph or

To access the About box:

1. Press 8 (Configuration) from the Main Menu.
2. Press 6 (About the ALPHA)

Warning: No modification of this equipment is allowed. Any unauthorised changes to the Alpha device may compromise product safety and/or data and as such Vitalograph cannot be held responsible and the device will no longer be supported. 

1.1 Indications for use

The device is a spirometer which measures patient respiratory parameters including FVC, FEV1, FEV6, PEF,  MVV and VC. The Vitalograph Alpha is a desktop spirometer designed for lung function testing for use on adults and pediatrics, 5 years and older, in a variety of environments such as hospital wards, health centers and private homes under the supervision of a healthcare provider.

1.2 Contraindications and precautions for use

1. No modification of this equipment is allowed. Any unauthorised changes to the Vitalograph Alpha device may compromise product safety and/or data and as such Vitalograph cannot be held responsible and the device will no longer be supported.
2. The Vitalograph Alpha is not designed as a sterile device.  Always follow the safety guidelines given by the manufacturer of cleaning and disinfectant chemicals.
3. For spirometry testing a new Bacterial Vital Filter (BVF) should be used for each subject to protect both device and subject. A BVF is for single subject use only. A delay of at least 5 minutes should be allowed between subjects to allow settling of previously aerosolized particles in the measuring device.
4. Spirometry may support or exclude diagnosis, but it cannot make one (ATS/ERS 2005).
5. When getting the Vitalograph Alpha ready for use ensure that the ribbed side of the tubing is connected to the ribbed half of the connector as per the instructions in section 5. If tubing is connected the wrong way, spirometry results may appear to be inverted.
6. When using the Vitalograph Alpha ensure that the flowhead connecting tube is not pinched or trapped as spirometry results may appear to be inverted.
7. Take care not to block the mouthpiece with the tongue or teeth during testing. A 'spitting' action or cough will give false readings. 
8. Subject fatigue may occur during spirometry testing depending on the subjects characteristics e.g age, health status. To avoid this the subject may sit during the testing or alternatively take a break between tests. When the Alpha device is used with Spirotrac a subject fatigue warning will appear after 8 manoeuvres and the maximum number of allowed manoeuvres in one session is 20.  
9. All spirometry standards recommend checking the accuracy of lung function measuring devices at least daily with a 3-L syringe to validate that the instrument is measuring accurately. The Vitalograph Alpha should never be outside accuracy limits. In normal use, calibration traceability certification is recommended as a part of the routine annual service. Accuracy should also be checked after cleaning or disassembling the spirometer for any reason, after adjusting calibration or if the flowhead or device has been dropped.
10. Operating the Vitalograph Alpha device from the USB is not possible. The USB can be used to re-charge the batteries only.
11. Service and repairs should be carried out only by the manufacturer or by Service Agents specifically approved by Vitalograph.
12. Medical Devices may be affected by cellular telephones and other personal or household devices not intended for medical facilities. It is recommended that all equipment used near the Vitalograph product comply with the medical electromagnetic compatibility standard. If interference is suspected or possible, switching off the offending device is the normal solution, as is required in aircraft and medical facilities. NON MEDICAL EQUIPMENT MUST BE KEPT OUTSIDE THE PATIENT ENVIRONMENT. Portable and mobile RF communications equipment can affect medical electrical equipment.

2. Main Components of the Vitalograph ALPHA

3. Features of the Vitalograph ALPHA

The Vitalograph ALPHA features include:

• Very high accuracy, linearity and stability
• Extremely simple to operate keypad with extra-large buttons
• Integral printer for instant results or printing to the Vitalograph Report Utility
• Storage of tests and demographic information
• Ability to exchange information with a PC
• Robust, proven fleisch-type flowhead. No moving parts or delicate sensors
• Simple cleaning. The flowhead completely dismantles for washing, disinfecting or even autoclaving.

4. Getting the Vitalograph ALPHA Ready For Use

1. Attach the flowhead to the Vitalograph ALPHA by the dual silicone tubing (Flowhead Connection Tube). Ensure that the coloured/ribbed tapping on the flowhead is connected to the ribbed side of the connection in the housing.
2. Open the printer door and feed the paper through the printer (See section Fitting a New Paper Roll).
3. Only use the Vitalograph ALPHA with the purpose-built low voltage power supply unit with which it is supplied. Attempted use with other power sources may cause irreparable damage and invalidate the warranty. The output from the power supply is 12 volts DC.
4. Connect the jackplug from the power supply into the socket on the rear of the Vitalograph ALPHA. Plug the mains plug into a suitable socket, operate the On/Off switch on the rear of the instrument and the Vitalograph ALPHA is ready for use.
5. For portability the Vitalograph ALPHA comes fitted with rechargeable batteries, which allows the device to be used for a period of time without the mains connected.

5. Power Management in the Vitalograph ALPHA

The Vitalograph ALPHA can be powered using the purpose-built low voltage Power Supply unit with which it is supplied or from the internal Battery Pack. When powered from the low voltage Power Supply the LED on the front face on the device will be green. The LED will be orange when the device is powered from the Battery Pack.

5.1. Battery Pack

The Vitalograph ALPHA is fitted with a rechargeable Battery Pack. This allows the device to be used without the 12V Power Supply connected. The battery pack can be re-charged by plugging in the 12V Power Supply. To fully re-charge switch off the Vitalograph ALPHA and leave it plugged in over-night.

The battery pack can also be re-charged by connecting the device to a PC via the USB cable. The USB connector is located on the right side of the device. Switch off the Vitalograph ALPHA when re-charging the batteries via USB.

The recommended battery pack replacement interval is 3 years. Battery replacement should be carried out only by the manufacturer, the approved importer or by Service Agents specifically approved by Vitalograph.

Note: Operating the Vitalograph ALPHA device from the USB is not possible. The USB can be used to re-charge the batteries only.

5.2. Battery Low Detect

The Vitalograph ALPHA has a number of battery power detect messages:

6. Operating the Vitalograph ALPHA

6.1. Entering Subject Information

After turning on the device, you are presented with the New Subject screen. A series of dialog boxes appear in which you enter information using the keypad. Instructions appear at the bottom of the screen to guide you through the information to be entered. Once you are ready to move onto the next dialog box, press the ‘Enter’ key on the keypad. These dialog boxes appear one at a time in the following order:

1. Reference Number
2. Age
3. Height
4. Gender
5. Population Group
   When entering subject information, you can specify the population group of the subject. There are a number of population groups to select from. These population groups have an associated predicted normal set and correction factor. These normal sets are usually based on sex, age and height and are useful when comparing a subject’s test results with predicted normal values from a suitable reference population.
6. Weight
7. Smoking History

If you wish to change the data entered press the ‘Delete’ key and enter the data again. Pressing the ‘Delete’ key repeatedly will step back through the dialogue boxes. Once you have finished entering the data press the ‘Enter’ key to bring you to the Main Menu.

The Population Group, Weight and Smoking History fields may not appear in the New Subject screen. This is dependent on the variant of the device.

Note: The Subject Information will now be printed to the internal printer if it is selected.

If you wish to enter different subject details select the ‘New Subject’ option from the Main Menu using the keypad. You will be asked if you wish to clear results.

• Press Yes to bring you to the New Subject screen, and enter the New Subject details as outlined above.
• Press No to bring you back to the Main Menu.
  
  

6.2. Performing a Test Session

6.2.1. Checks to Make before Performing a Test Session

1. Before starting a test session, there are a number of checks which should be made:
2. Ensure that the accuracy of the Vitalograph ALPHA unit was checked recently. (Refer to the section on Checking Accuracy)
3. Ensure all the required demographic information is entered for the subject.

 

6.2.2. Performing a VC Test

Perform the VC test as follows:

1. Select the ‘VC Test’ option from the Main Menu using the keypad.
2. Wait for the ‘Exhale to Begin’ icon to appear.
   

This indicates that the Vitalograph ALPHA unit is ready to accept a blow.

Note: You can view the results as either a Volume/time graph or a Volume bar graph:

1. Press key 1 for Volume/time (V/t) graph.
2. Press key 2 for Volume bar graph.

 

1. The VC test can be performed using two methods. Read either of the following instructions to the subject so that testing is performed properly:

   Method 1:

   1. Stand up
   2. Keep the flowhead away from your mouth.
   3. Inhale as deeply as possible and insert the bacterial viral filter into your mouth, clamping it between your teeth.
   4. Close your lips around the bacterial viral filter.
   5. Exhale normally for as long as possible.

Method 2:

Note: Method 2 can only be used when the Volume/Time (V/t) graph is selected as the display option. This method cannot be used when the Volume bar graph is selected as the display.

1. Stand up.
2. Insert the bacterial viral filter into your mouth and, clamping it between your teeth.
3. Close your lips around the bacterial viral filter.
4. Breathe in and out normally. This is tidal breathing.

   When you are happy that the subject has achieved steady tidal breathing, continue with:

5. Exhale as deeply as possible.
6. Inhale as much as possible (speed is not important) and when fully inhaled.
7. Return to tidal breathing, i.e. breathe in and out normally again.

The VC values recorded for the blow are tabulated. The best VC value for the current session and the Lower Limit of Normality (LLN) are also displayed.

3. Repeat to perform another VC test if required.
4. After performing the VC tests press the ‘Enter key’ to exit the VC Test screen. This brings you back to the Main Menu.

 

6.2.3. Performing an FVC Test

1. Select the ‘FVC Test’ option from the Main Menu using the keypad.
2. Wait for the ‘Exhale to Begin’ icon to appear.

   

   This indicates that the Vitalograph ALPHA unit is ready to accept a blow.

   Note: You can view the results as either a Volume/time (V/t) or a Flow/Volume (F/V) graph:

   1. Press key 1 for Volume/time graph.
   2. Press key 2 for Flow/Volume graph.

3. The FVC test can be performed using 2 methods as follows. Read either of the following instructions to the subject so that testing is performed properly:

   Method 1:

   1. Stand up.
   2. Keep the flowhead away from your mouth.
   3. Inhale as deeply as possible, then inset the bacterial viral filter into your mouth, clamping it between your teeth.
   4. Close your lips around the bacterial viral filter.
   5. Exhale as much and as quickly as possible and try to keep exhaling for at least 6 seconds.
   6. If inspiratory indices are selected, then inhale as quickly as possible.

   Method 2:
   

   1. Clip on the nose clip to seal your nose.
   2. Put the bacterial viral filter (BVF) into your mouth, biting it lightly.
   3. Seal your lips around the mouthpiece
   4. Breathe in and out normally. This is called tidal breathing.

When you are happy that the subject has achieved steady tidal breathing, continue with:

5. Inhale as deeply as possible
6. Exhale as much and as quickly as possible, and when fully exhaled
7. Inhale fully as quickly as possible
8. Return to tidal breathing, i.e. breathe in and out normally again.

 

4. The FVC, FEV1, FEV1ratio and PEF values recorded for the blow are tabulated. The best FVC, FEV1, FEV1ratio and PEF for the current session are displayed.

   The test quality (QA) is shown at the bottom of the test screen.

   The number of tests performed and the Test Grade are shown in the V/t screen. Each test series is graded in relation to its repeatability between acceptable manoeuvres. The quality Grades are A, B, C, D and F.

   The repeatability (Within) of FVC and FEV1 are shown in the F/V screen. The repeatability information is displayed if at least two tests are performed. I Bars on the F/V graph are shown for FEF25, FEF 50 and FEF75. An I Bar for FVC is also shown on the Volume axis. The upper mark on the I Bars indicates the predicted value for the subject. The lower mark on the I Bar indicates the LLN value for the subject. The I Bars are based on the predicted sets and will be shown if sufficient subject demographics information is entered.

5. Repeat to perform another FVC Test if required.
6. After performing the FVC tests press the ‘Enter’ key to exit the FVC Test screen. This brings you back to the Main Menu.

6.3. Saving the Test Session

1. Select ‘Post Mode’ from the Main Menu using the keypad.
2. Select ‘Save Current Subject Pre Test’ from the Post Mode screen using the keypad. A message will appear informing you of the memory location where the test session will be saved. There are nine memory locations on the Vitalograph ALPHA. The best three tests will be saved.

   Note: If a Compact Flash card is inserted into the Compact Flash connector at the right side of the device, then all test blows and not just the best three will be saved to the Compact Flash card. Results are saved as per the format outlined in the European Respiratory Journal, 2005; 26: Pages 319-338: ATS/ERS Task Force: Standardisation of Lung Function Testing.

6.4. Performing a Post Test Session

A Post test session can be performed on an FVC test session following the administration of drugs. Post drug delivery performance is measured versus pre delivery.

To perform a Post test:

1. Select ‘Post Mode’ from the Main Menu using the keypad.
2. If you want to perform a Post Test on the Pre-test Session just performed select ‘Set Post Mode for Current Subject’. This will return you to the Main Menu screen. The text Post Mode will appear on the top right hand corner of the screen.
3. If you wish to perform a Post Test on a different subject or Pre-test:
   1. Select ‘Select a Subject from the Pre-Store’.
   2. A message ‘Warning! Current Results will be cleared’ will appear. Select Yes and the Select Subject screen will appear.
   3. Select the number of the Pre-test you wish to perform the Post test on. This will return you to the Post Mode screen.
   4. Press ‘Enter’ to return you to the Main Menu screen.
4. Perform the Post FVC test as outlined in section Performing a Test Session.

Note: If there is no Pre-Test performed, the message No FVC Tests Performed will appear.

6.5. Printing the Test Session

You can print the current test session for the subject by selecting ‘Print’ from the Main Menu.

The Vitalograph ALPHA has an internal printer. It can also be connected through the USB port at the side of the unit to the Vitalograph Reports Utility, so that the report can be written to a PC.

The information printed on the session report can be configured to suit individual requirements. Refer to section on Report Settings.

The test parameters on the report will vary according to regional requirements. The test parameters and their definitions are available from the Help files, which can be accessed from the Main Menu.

Note: The internal (thermal) printout will fade over time when exposed to light or heat. If a permanent record is required, photocopy the thermal printout or send the report to the Vitalograph Reports Utility. Refer to the section on Configuration for information on selecting the internal or Vitalograph Reports Option.

6.6. Clear Results

If you wish to delete the current session you can do this as follows:

1. Select the ‘Clear Results’ option from the Main Menu using the Keypad.
2. A message will appear ‘Warning! Current Results will be Cleared. Do you wish to proceed?’ in the Clear Results screen. Select ‘Yes’ to delete the current results and return to the Main Menu. Select ‘No’ to cancel the delete and return to the Main Menu.

6.7. Checking Accuracy

All spirometry standards (e.g. ATS/ERS/BTS/ANZRS) recommend checking the accuracy of lung function measuring devices at least daily with a 3-L syringe to validate that the instrument is measuring accurately. The Vitalograph ALPHA should never be outside accuracy limits unless damaged or in a fault condition. In this event, see the fault-finding guide. In normal use, calibration traceability certification is recommended as a part of the routine annual service.

ATS recommendations require that the difference between the volume measured by the spirometer and the volume pumped into the spirometer from a syringe is within 3%.

Follow these steps to check the accuracy of the unit.

1. Select Accuracy Check from the Main Menu using the keypad.
2. Pump air through the flowhead to bring it to ambient temperature.
   If the flowhead has very recently been used for testing or has come from a cold environment, its temperature should be equilibrated with ambient by pumping air through it from the syringe several times.
3. Press the ‘Enter’ key to bring you into the Accuracy Check screen and follow the on-screen instructions.

   Note: Press the ‘Del’ key to exit the Accuracy Check screen and return to the Main Menu. The accuracy check will not be logged to the Vitalograph ALPHA memory in this case.

4. If an Accuracy Check report is required select the Report option.

   Note: If the device is outside calibration you will be given the option to update the calibration. If you select this option you will be brought through the accuracy check routine again.

   6.7.1. When to Check Accuracy

   • In accordance with your own established procedures
   • After annual maintenance checks
   • After cleaning or disassembling spirometer for any reason
   • After adjusting calibration
   • If the flowhead has been dropped

6.8. Viewing Current Subject Details

To view the Current Subject details:

1. Select ‘Post Mode’ from the Main Menu using the keypad.
2. Select ‘View Current Subject’ from the Post Mode screen.
3. The Current Subject screen will be displayed.

   Note: You will not be able to modify any of the subject details.

6.9. Deleting Stored Subjects/Test Results

To delete individual Stored Subjects/Test results:

1. Select ‘Post Mode’ from the Main Menu using the keypad.
2. Select ‘Delete Stored Tests’ from the Post Mode screen. You are presented with the list of the Subjects and the associated test stored on the device. A maximum of nine Subject/Tests can be stored on the device in locations 1-9 as indicated in the Delete Subject screen.
3. Select the number of the Subject/Test you wish to delete using the keypad. This location will then be marked as ‘Empty’.
4. Continue to delete test as required.
5. Press ‘Enter’ to return to the Post Mode screen.

To delete all Stored Subjects/Test results:

1. Select ‘Post Mode’ from the Main Menu using the keypad.
2. Select ‘Clear Pre Store’ from the Post Mode screen.
3. A message ‘Warning! All data in pre store will be cleared. Do you wish to proceed?’ will appear in the Clear Results screen.
4. Select ‘Yes’ to delete the all data and return to the Post Mode screen. Select ‘No’ to cancel the delete and return to the Post Mode screen.

6.10. Configuration Options

There are a number of Configuration options available on the Vitalograph ALPHA device. To access these, press the ‘Configuration’ option on the Main Menu using the keypad. The options available are:

6.10.1. Preferences

This will allow you to configure the device to your own requirements. Selecting this will give you the following options:

Printer

This allows you to either print the test report to the Internal Printer or send it to the Vitalograph Reports Utility on a PC. Press key ‘1’ on the keypad to switch between the two options.

Note: In order to send the report to the Vitalograph Reports Utility it is necessary to have the Vitalograph Reports Utility installed on your PC and the Vitalograph ALPHA connected to your PC via a USB cable.

 

Units

This allows you to select the units as Metric or US (Imperial). Press key ‘2’ on the keypad to switch between the two options.

 

Graph Type

This allows you to select the graph type to be shown as default in the FVC test screen, Press key ‘3’ on the keypad to switch between the Volume/Time (V/T) and Flow/Volume (F/V) graphs.

 

Test Acceptability

This allows you to manually accept the tests performed, or allow the device to determine test acceptability (automatic). Press key ‘4’ to switch between Manual and Automatic.

 

VC Test Type

This allows you to select the graph type to be shown as default in the VC test screen, Press key ‘5’ on the keypad to switch between the Volume/Time (V/T) and Volume Bar graphs.

 

6.10.2. Date/Time

1. Select ‘Date/Time’ from the Configuration screen using the keypad.
2. In the Date/Time screen press key ‘1’ to change the year. Enter the revised year as required using the keypad and press ‘Enter’. The Month, Day, Hour and minute fields are modified in the same way.
3. To modify the Date Format press key ‘6’ to switch between the different date formats:
   DD/MM/YYYY
   MM/DD/YYYY
   YYYY/MM/DD
4. Press ‘Enter’ to save the change.
5. To modify the Time Format press key ‘7’ to switch between 24 hour and 12 hour.
6. Press ‘Enter’ to save the change.
7. Once you have finished modifying the date and time settings press ‘Enter’ to save the changes and return to the Configuration screen. Press ‘Delete’ to cancel the changes made and return to the Configuration screen.

 

6.10.3. Report Settings

The information printed on the session reports can be configured to suit individual requirements. The Vitalograph ALPHA can print to the internal printer or send the report to the Vitalograph Reports Utility.

1. Select ‘Report Settings’ from the Configuration screen using the keypad. You are presented with the list of items that can be configured on the test reports.
2. In the Report Settings screen press key ‘1’ to switch the Volume/time (V/t) graph on or off.
3. Press key ‘2’ to switch the Flow/Volume (F/V) graph on or off.
4. Press Key ‘3’ to switch the Comments on of off.
5. Press key ‘4’ to switch the Test QA messages on or off.
   
6. Press key ‘5’ to switch the Interpretation of the test results on or off.
   
7. Press key ‘6’ to switch between showing SDS (Standard Deviation Score) or %Predicted in the session table of results. In the session table of results the % of Predicted value will be printed by default. If SDS is on, the SDS (Standard Deviation Score) will be printed instead.
8. Press key ‘7’ to either show the Best Test only on the report or the Three Tests saved to the database.
9. Press key ‘8’ to switch colour on or off. This option is not available for the internal printer.
10. When you have finished modifying the Report Settings press ‘Enter’ to save the changes and return to the Configuration screen. Press ‘Delete’ to cancel the changes made and return to the Configuration screen.

 

6.10.4. Syringe/Calibration

The Vitalograph ALPHA should never be outside accuracy limits unless damaged or in a fault condition. In this event, see the fault-finding guide. In normal use, calibration traceability certification is recommended as a part of the routine annual service.

1. Select the Syringe/Calibration menu using the keypad. You are presented with three options:
   1. Set Syringe Volume
   2. Linearity Check
   3. Calibration

      Set Syringe Volume:

      1. Select Precision Syringe from the Syringe/Calibration screen using the keypad.
      2. Follow on screen instructions to enter the volume of the calibrated syringe you are using.
      3. Press ‘Enter’ to save the new volume entered and return to the Syringe/Calibration screen. Press Delete to cancel the changes made and return to the Syringe/Calibration screen.

      Linearity Check:

      1. Select Linearity Check from the Syringe/Calibration screen using the keypad.
      2. Pump air through the flowhead to bring it to ambient temperature. If the flowhead has very recently been used for testing or has come from a cold environment, its temperature should be equilibrated with ambient by pumping air.
      3. Press the ‘Enter’ key to bring you into the Linearity Check screen.
      4. Using a 3L Calibrated syringe pump air into the flowhead at a slow rate of <2L/s. Immediately withdraw the syringe at a slow rate. This manoeuvre should show on the graph between the two red lines. If it is a correct manoeuvre the table on the screen will show ‘Test 1’, and the FVC and FIVC values will be updated.

         Note: Press the ‘Del’ key to exit the Linearity Check screen.

      5. Repeat for the slow rate three times in total.
      6. Repeat the procedure outlined in iv & v for a medium rate >2L/s and <6L/s. This manoeuvre should show on the graph between the red and green lines. If it is a correct manoeuvre the test number and the FVC and FIVC values will be updated in the table.
      7. Repeat for the medium rate three times in total.
      8. Repeat the procedure outlined in iv & v for a fast rate >6L/s. This manoeuvre should show on the graph between the outside green lines. If it is a correct manoeuvre the test number and the FVC and FIVC values will be updated in the table.
      9. Repeat for the fast rate three times in total.
      10. When all the manoeuvres are complete press ‘Enter’ for the result.
      11. If a Linearity Check report is required select the Report option.
          

      Calibration:

      1. Select Calibration from the Syringe/Calibration screen using the keypad.
      2. Pump air through the flowhead to bring it to ambient temperature. If the flowhead has very recently been used for testing or has come from a cold environment, its temperature should be equilibrated with ambient by pumping air through it from the syringe several times.
      3. Press the ‘Enter’ key to bring you into the Calibration screen and follow the on-screen instructions.

      Note: Press the ‘Del’ key to exit the Calibration screen.

      4. If a Calibration report is required select the Report option.

6.10.5. Sound Volume

1. Select the ‘Sound Volume’ option from the Configuration screen using the keypad.
2. Adjust the sound level up by pressing key ‘2’.
3. Adjust the sound level down by pressing key ‘8’.
4. When you have finished changing the sound level press ‘Enter’ to save the changes and return to the Configuration screen.

6.11. Fitting a New Paper Roll

The Vitalograph ALPHA is supplied with a roll of paper fitted into the printer. (Note: The outside of the roll of paper will not give a strong print impression due to loss of sensitivity on exposure to light).

To replace the paper follow the instructions listed below and shown in figure 2.

1. Open the printer door to expose the head of the printer and the paper cartridge.
2. Remove the paper cartridge that holds the empty paper roll from the ALPHA.
3. Remove the empty paper roll from the paper cartridge.
4. Put the new roll of paper into the paper cartridge and unroll about 12cm (6 inches) of paper. (Note: To make fitting easier, create a point in the middle of the paper by tearing or cutting the two corners of the leading edge of the paper).
5. Clip the paper cartridge back into place between the back of the Vitalograph ALPHA unit and the inside of the open door. The paper should be coming out from the bottom of the roll and pointing towards the printer. This will allow you more access to the printer feed mechanism.
6. In the home screen, lift the green lever on the printer.
7. Feed the leading edge of the paper into the bottom slot of the printer until the paper appears through the top of the printer. The paper can now be pulled through. To aid in feeding the paper through the printer, press the “Enter” key on the keypad. This will feed a short length of paper through the printer.
8. Close the green lever.
9. Hold the paper over the paper tear bar and close the door.

Note: The Vitalograph logo should be facing you on the right edge of the paper.
Warning: The paper tear bar has sharp edges. Users should take care not to cut their fingers.

Figure 2

7. Cleaning Instructions

7.1. Cleaning and Low Level Disinfecting the Vitalograph ALPHA

The parts of the Vitalograph Alpha that make up the flowhead, which comes into contact with subjects being tested, require low level disinfection. The body of the device may be cleaned with an alcohol wipe.

A spirometer is not designed as a ‘sterile’ device.

A new BVF should be used with each subject to prevent cross contamination, the BVF protects both the subject and the device.

One cleaning cycle should be performed weekly.

It is recommended that the complete flowhead and flowhead connection tube be replaced annually.

Table of Materials Used & Cleaning/Disinfection Methods

7.2. Disassembling and Cleaning the Fleisch Flowhead

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 examine them for damage or contamination. If they are damaged or blocked, discard and replace with new parts.
3. To remove the flowhead body from the fleisch element, place the fleisch element on a hard, flat surface with the largest diameter at the top. Push down on the flowhead body with thumbs and forefingers until it reaches the flat surface. A final pulling and twisting action will separate the parts.




Flowhead Complete 'O' rings Flowhead End Cap Flow Conditioning Meshes Flowhead Cone Fleisch Element Flowhead Body Lubrication: Silicone Grease

Figure 3: Flowhead Assembly


4. To clean the fleisch element, swill vigorously in warm soapy water. Do not attempt to “rub” or “scrub” at capillaries.
5. To clean the flowhead end cap, flow conditioning meshes and flowhead cone, wash in warm soapy water. Rub surfaces to remove any visible soiling.
6. Examine all parts to ensure they are visibly clean. If not visibly clean repeat the cleaning process.
7. Rinse all parts in distilled water.
8. Leave to dry completely before reassembling. Drying the fleisch element components may require placing them in a warm place overnight. A drying cabinet is ideal.
   

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

7.3. Reassembly and Low Level Disinfection of the Fleisch Flowhead

1. Examine the fleisch element to ensure that no liquid or particles remain in the holes, grooves or pressure tappings.
2. Check the 'O' rings for damage and ensure that they are correctly positioned within the grooves.
3. Apply a very small amount of silicone grease to ‘O’ Rings and inside the surfaces of the flowhead body. Wipe off any visible amounts of grease. Ensure that the tiny annular holes on the outside of the fleisch element are not blocked.
4. When re-assembling the flowhead, ensure that the blue pressure tapping is nearest to the largest diameter of the fleisch element.
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 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 and push the flowhead cone onto the smaller diameter.
8. Wipe all external surfaces of the flowhead with a 70% isopropyl alcohol impregnated cloth.
9. When attaching the flowhead connection tube ensure that the matching coloured/serrated edge pressure tappings on the flowhead and the Vitalograph Alpha are connected to each other.

IT IS RECOMMENDED THAT AN ACCURACY CHECK IS CARRIED OUT FOLLOWING REASSEMBLY TO VERIFY CORRECT OPERATION AND ACCURACY.

8. Fault Finding Guide

9. Customer Service

Service and repairs should be carried out only by the manufacturer, the approved importer or by Service Agents specifically approved by Vitalograph.

For the names and addresses of approved Vitalograph Service Agents or to arrange spirometry workshops, please refer to the contact information at the start of this manual.

10. Consumables and Accessories

11. Explanation of Symbols

	Type BF equipment
	Class II
VA	Power rating
	Voltage DC
	Attention (reference relevant section in manual)
	Manufacturer
	Year of Manufacture

Other Labels

	USB connector
	The device must be taken to separate collection at the product end-of-life. Do not dispose of these products as unsorted municipal waste.

12. Technical Specifications

13. CE Notice

Marking by the symbol indicates compliance of the Vitalograph ALPHA to the Medical Devices Directive of the European Community. Such marking is indicative that the Vitalograph ALPHA meets or exceeds the following technical standards:

Medical Devices may be affected by cellular telephones and other personal or household devices not intended for medical facilities. It is recommended that all equipment used near the Vitalograph product comply with the medical electromagnetic compatibility standard and to check before use that no interference is evident or possible. If interference is suspected or possible, switching off the offending device is the normal solution, as is required in aircraft and medical facilities.

Medical electrical equipment needs special precautions regarding EMC and needs to be installed and put into service according to the EMC information provided,

Portable and mobile RF communications equipment can affect medical electrical equipment.

14. FDA Notice

Caution: Federal Law restricts this device to sale by, or on the order of a physician.

15. Declaration of Conformity

Product: Model 6000 Vitalograph ALPHA

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

• 

  European Medical Devices Directive {MDD} 93/42/EEC, as amended.

  This device is classified as 2a per Annex IX of the MDD also meets the provisions of the Essential Requirements, Annex I, via compliance with Annex II of the Medical Devices Directive as per Article 11, section 3a, excluding point 4 of Annex II.

• Canadian Medical Device Regulation {CMDR SOR/98-282}

• FDA Quality System Regulation {QSR} 21 CFR 820.

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

Certifying Body: British Standards Institute {BSI}.

{For 93/42/EEC and CMDR}.

BSI Notified Body #: 0086

Certificate Nos. CE 00772, CE 85553, MD 82182, FM 83550

Signed on behalf of Vitalograph (Ireland) Ltd.

B. R. Garbe.

Group Managing Director

16. Guarantee

Subject to the conditions listed below, Vitalograph Ltd. and its associated companies, (hereinafter called the Company) guarantee to repair or at its opinion replace any component thereof, which, in the opinion of the Company is faulty or below standard as a result of inferior workmanship or materials.
The conditions of this Guarantee are:

1. This Guarantee shall only apply to hardware defects which are notified to the Company or to its accredited distributor within 1 year of the date of purchase of the equipment, unless otherwise agreed in writing by the Company
2. Software (meaning computer software, or user installable modules) is guaranteed for 90 days from the date of purchase.
3. The Company warrants that the software when correctly used in conjunction with the hardware will perform in the manner described in the Company's literature and user manuals. The Company undertakes to rectify at no expense to the customer any software failure notified within the period stated above, provided that the failure can be recreated and the software has been installed and used in accordance with the user manual. Notwithstanding this clause, the software is not warranted to be free of errors.
4. This Guarantee does not cover any faults caused by accident, misuse, neglect, tampering with the equipment, use of consumable items or parts not approved by the Company, or any attempt at adjustment or repair other than by personnel accredited by the Company, nor does it cover reinstatement of any configuration changes caused by the installation of any software.
5. If a defect occurs, please contact the supplier from whom it was purchased for advice. The Company does not authorise any person to create for it any other obligation or liability in connection with Vitalograph® equipment
6. This Guarantee is not transferable and no person, firm or company has any authority to vary the terms or conditions of this Guarantee.
7. To the maximum extent permitted by law, the Company does not accept liability for any consequential damages arising out of the use of, or inability to use any Vitalograph® equipment.
8. This Guarantee is offered as an additional benefit to the Consumer’s statutory rights and does not affect these rights in any way.