Vitalograph logo
ALPHA Touch

Model 6000

User Training Manual

Device illustration

CE


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

Manufacturer symbol Vitalograph (Ireland) Ltd.
Gort Road Business Park,
Ennis, Co. Clare, V95 HFT4
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 2014
Current Edition (Issue 9)
Cat. No. 07586

Vitalograph logo is a registered trademark


Table of Contents

  1. DESCRIPTION OF THE VITALOGRAPH ALPHA TOUCH
    1. INDICATIONS FOR USE
    2. CONTRAINDICATIONS AND PRECAUTIONS FOR USE
  2. MAIN COMPONENTS OF THE VITALOGRAPH ALPHA TOUCH
  3. FEATURES OF THE VITALOGRAPH ALPHA TOUCH
  4. GETTING THE VITALOGRAPH ALPHA TOUCH READY FOR USE
  5. POWER MANAGEMENT IN THE VITALOGRAPH ALPHA TOUCH
    1. BATTERY PACK
    2. BATTERY LOW DETECT
  6. OPERATING THE VITALOGRAPH ALPHA TOUCH
    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. PERMANENT STORAGE OF PRE-TEST SESSIONS
    6. PRINTING AND VIEWING THE TEST SESSION
    7. CLEAR RESULTS
    8. CHECKING ACCURACY
      1. When to Check Accuracy
    9. CONFIGURATION OPTIONS
      1. Test Preferences
      2. Database
      3. Calibration
      4. Settings
      5. Subject Options
      6. Smart Options
      7. Report Options
    10. FITTING A NEW PAPER ROLL
  7. CLEANING INSTRUCTIONS
    1. CLEANING AND DISINFECTING THE VITALOGRAPH ALPHA TOUCH
    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

Components

Figure 01



1. Description of the Vitalograph ALPHA TOUCH

The Vitalograph ALPHA Touch 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 using Spirotrac or entered via a keypad and stored, together with spirometry test data.  Current test data can be viewed on the LCD, 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 a service agent.

To access the About box:

  1. Press the configuration button on the main menu
  2. Press about button

 The main components of the ALPHA Touch device are shown in Figure 01 above.


Warning: No modification of this equipment is allowed. Any unauthorised changes to the Alpha Touch 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 Touch 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 Touch 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 Touch 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 Touch 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 Touch 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 Touch 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 Touch 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 Touch 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 TOUCH


A
P.C Software
B
Medically Approved Power Supply
C
Flowhead
D
Flowhead Connection Tubing
E
Colour LCD and Touch Panel Display
F
Power LED and Keypad (Up/Down/Enter/Clear)
G USB Cable
H Internal Thermal Printer



 

3. Features of the Vitalograph ALPHA TOUCH

The Vitalograph ALPHA Touch features include:

 

4. Getting the Vitalograph ALPHA TOUCH Ready For Use

Note: First check that the contents of the packaging correlate with what is outlined on the contents label on the inside of the packaging carton. If the device has just been unpacked or transported, ensure that it is left sitting, fully powered, in its test environment for at least an hour before use.
  1. Attach the flowhead to the Vitalograph ALPHA Touch 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 Touch 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 Touch. Plug the mains plug into a suitable socket, operate the On/Off switch on the rear of the instrument and the Vitalograph ALPHA Touch is ready for use.
  5. For portability the Vitalograph ALPHA Touch 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 Touch

The Vitalograph ALPHA Touch can be powered using the 12V 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.

The Power Supply unit should be checked regularly and replaced when necessary.

5.1 Battery Pack

The Vitalograph ALPHA Touch 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 12 V Power Supply. To fully re-charge switch off the Vitalograph ALPHA Touch 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 Touch 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 Touch 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 Touch has a number of battery power detect symbols:

Battery Low When the Battery Pack starts to run low the Battery Low icon will flash on the Main Menu screen.You will be allowed to continue to use the device. It is advised that you plug in the 12V Power Supply to re-charge the batteries and continue testing.
Battery Discharged When the Battery Pack is approaching fully discharged the Battery Discharged icon will appear continuously on the Main Menu screen.If you press any of the keys a warning message will appear and you will not be allowed to proceed into any other screen. Plug in the 12V Power Supply to re-charge the batteries and continue testing.

 

6. Operating the Vitalograph ALPHA Touch

6.1 Entering Subject Information

After turning on the device, you are presented with the Main Menu screen. 

  1. Select the Subject button, to bring you into the Select Subject screen.
  2. You can list the subjects saved on the device by selecting either the Name or ID tab.
  3. To select a subject from the database, highlight the subject. This will allow you the view the subject details.  Select Enter to make the subject current.
  4. To create a new subject, select the New tab. Enter the subject details by hi-lighting the required field and typing in the information using the touch panel keypad. Press the Enter button to save the subject to the database and return to the Home Menu.


Note: The current subject surname and forename will be displayed on the bottom left hand corner of the screen. If the subject name is not entered then the subject ID will be displayed. If the subject has test session results associated with it then the subject name and ID will appear in black. If there are no test session results then the subject name and ID will appear in grey.

6.2 Performing a Test Session 

Checks to Make before Performing a Test Session

Before starting a test session, there are a number of checks which should be made:

  1. Ensure that the accuracy of the Vitalograph ALPHA Touch unit was checked recently. (Refer to the section on Checking Accuracy)
  2. Ensure a subject is selected (subject ID or name will appear on the status bar at the bottom of the Main Menu) and the required demographic information is entered for the subject.
  3. Fit a disposable BVF mouthpiece. The use of a disposable noseclip is also recommended.

Performing a VC Test

Perform the VC test as follows:

  1. Select the ‘VC Test’ option from the Main Menu.
  2. Wait for the ‘Exhale to Begin’ icon to appear.
Blow Icon
This indicates that the Vitalograph ALPHA Touch unit is ready to accept a blow.

Note: You can view the results as either a Volume/time graph or a Volume bar graph by selecting the relevant tab.

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. Sit upright, fit the nose clip and relax.
  2. Keep the flowhead away from your mouth.
  3. Inhale as deeply as possible, hold your breath, then insert the mouthpiece carefully into your mouth, clamping it gently between your teeth.
  4. Seal your lips around the mouthpiece and keep your tongue down.
  5. Exhale for as long as possible. It is vital that the operator encourages the subject to keep exhaling to ensure all air is expelled.
  6. Listen for two beeps. This indicates that Vitalograph ALPHA Touch is ready for the next blow.

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. Sit upright, fit the noseclip and relax.
  2. Insert the mouthpiece carefully into your mouth, clamping it gently between your teeth.
  3. Seal your lips around the mouthpiece and keep your tongue down.
  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 for as long as possible. It is vital that the operator encourages the subject to keep exhaling to ensure all air is expelled.
  6. Inhale as deeply 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.

  1. Repeat the blow three times or more to obtain good test quality.
  2. After performing the VC tests press the Cancel button to exit the VC Test screen. This brings you back to the Main Menu.

Performing an FVC Test


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

    Blow Icon
    This indicates that the Vitalograph ALPHA Touch 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 by selecting the relevant tab.
  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. Sit upright, fit the noseclip and relax.
  2. Hold the unit, keeping it away from your mouth.
  3. Inhale as deeply as possible, hold your breath, then insert the mouthpiece carefully into your mouth, clamping it gently between your teeth.
  4. Seal your lips around the mouthpiece and keep your tongue down.
  5. Exhale for as long as possible. Keep blowing for at least 6 seconds. (From the very beginning of the blow the operator should encourage the subject to keep going in a lively fashion. Keep eye contact with the subject)
  6. If inspiratory indices are selected, then inhale as quickly as possible.
  7. Listen for two beeps. This indicates that Vitalograph ALPHA Touch is ready for the next blow.

Method 2:
  1. Sit upright, fit the noseclip and relax.
  2. Insert the mouthpiece carefully into your mouth, clamping it gently between your teeth.
  3. Seal your lips around the mouthpiece and keep your tongue down.
  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 for as long as possible. Keep blowing for at least 6 seconds. (From the very beginning of the blow the operator should encourage the subject to keep going in a lively fashion. Keep eye contact with the subject)
  7. Inhale fully as quickly as possible
  8. Return to tidal breathing, i.e. breathe in and out normally again.


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

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

    The best 3 tests performed and the Test Grade are shown in the test 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 also shown. The repeatability information is displayed if at least two tests are performed. I Bars on the F/V graph are shown for FEF25, FEF50 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.
  2. Repeat the blow three times or more to obtain good test quality.
  3. To view results select the results tab.
  4. After performing the FVC tests press the Cancel button to exit the FVC Test screen. This brings you back to the Main Menu.

Note: The measurements obtained from a lung function test form part of the various findings of a physician in the detection, diagnosis and control of chest diseases. Spirometry may support or exclude diagnosis, but it cannot make one.

6.3 Saving the Test Session

The test session is saved to the database by following the on-screen messages. 

Note: If a compact flash card is inserted into the compact flash card 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.
  2. If you want to perform a Post Test on the Pre-test Session just performed select ‘Perform Post test on Current Subject’. This will return you to the test screen. The text Post Mode will appear on the graph.
  3. If you wish to perform a Post Test on a different subject or Pre-test:    
    1. Select ‘Select Subject from List’. 
    2. A message ‘Warning! Current test session will end. Do you want to save the test session?’ will appear.  Select Yes and the Select Subject screen will appear.   
    3. Select the subject you wish to perform the Post test on, and the Select Test Session screen will appear. Select the test session.        
      1. Note: The words Pre, VC or FVC or a combination of these will appear after the session ID. 
      2. If the word Pre appears then a POST test session has already been performed on this pre session.    
      3. If the word VC appears then a VC test has been done as part of the pre-session.    
      4. If the word FVC appears then an FVC test has been performed as part of the pre-session.
    4. Press ‘Enter’ to bring you to the test screen. The text Post Mode will appear on the graph.
  4. Perform the Post FVC test as outlined in section Performing a Test Session.

6.5 Permanent Storage of Pre-Test Sessions

The Post Mode screen also gives you the option to save and recall test sessions to and from a permanent storage location on the device. This permanent storage does not get deleted when test sessions are sent to Spirotrac V or printed. To access this option select ‘Permanent Storage’. 

The Permanent Storage screen gives you four options:
  1. Save Test to Permanent Storage: When this option is selected a message will appear informing you of the memory location where the test session will be saved. There are nine permanent memory locations on the Vitalograph ALPHA Touch.
  2. Load Test from Permanent Storage: When this option is selected the list of permanent pre-test sessions will appear. Select the required pre-test session from the list and select enter to bring you into the Post Mode screen.
  3. Delete Test from Permanent Storage: When this option is selected the list of permanent pre-test sessions will appear. Select the Test session you wish to delete and press enter. This location will then be marked as ‘Empty’.
  4. Delete all Tests from Permanent Storage. When this option is selected a warning message will appear:- ‘Do you want to delete all tests stored in permanent storage?’.  Press enter to delete all tests.

6.6 Printing and Viewing the Test Session

You can print the current test session for the subject by selecting ‘Print’ from the FVC Test screen.

The Vitalograph ALPHA Touch 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 printed via a PC. The information printed on the session report can be configured to suit individual requirements. Refer to section on Report Settings.

You can also select the Report option from the Main Menu. If you already have a Current Subject selected the following options are available:

  1. Current Test Session: You can select to print the current test session. To print the current session, select the print icon at the top of the session results screen.
  2. Select Test Session: You can select a test session for the current subject. To print the session, select the print icon at the top of the session results screen.
  3. All Test Sessions: You can print all test sessions for the current subject but only to a P.C. All test sessions can’t be printed using the internal printer.

You can also print Test Session(s) from a different subject in the database. This is done by selecting the ‘Select’ tab in the View and Report screen. The following options are available:

  1. Select Test Session: You must first select a subject from the database, and then select a test session for that subject. To print the selected session, select the print icon at the top of the session results screen.
  2. All Test Sessions: This will print all test sessions performed on a subject but only to a P.C. All test sessions can’t be printed using the internal printer. When you select this option you must first select a subject from the database.
  3. All Test Sessions Between…: This will print all sessions stored on the device between specified dates but only to a P.C. This can’t be printed using the internal printer.. You must first select the dates.

The default test parameters on the report will vary according to regional requirements. Test parameters can be configured to suit individual requirements. Refer to section on Parameters.

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.


6.7 Clear Results

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

  1. Select the ‘Clear’ option from the Main Menu.
  2. A message will appear ‘Warning! Current Test Session Will End. Do you want to save the test session?’  Select ‘Yes’ to save the current test session and return to the Main Menu. Select ‘No’ to not save the current test session and return to the Main Menu. Select ‘C’ to cancel the operation and continue with the current test session.

6.8 Checking Accuracy

All spirometry standards (e.g. ATS/ERS/BTS/ANZRS) recommend on measuring devices at least daily with a 3-L syringe to validate that the instrument is measuring accurately. The Vitalograph ALPHA Touch 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. Enter the Syringe volume and reference using the touch panel keypad.
  3. Depending on how the device is configured you may be prompted to enter the ambient temperature, humidity (0-99%), pressure (25-31 inHg or 850-1060 hPa-mbar) and altitude (1-8500m). Enter these values using the touch panel keypad.
  4. 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.
  5. Press the ‘Enter’ key to bring you into the Accuracy Check screen and follow the on-screen instructions.
Note: Press the ‘C’ key to exit the Accuracy Check screen and return to the Main Menu. The accuracy check will not be logged to the Vitalograph ALPHA Touch memory in this case.
  1. 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.

When to Check Accuracy


6.9 Configuration Options

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


Test Preferences

This allows you to configure the test screen to your requirements. The following options are available:

  1. FVC Display: You can select to show F/V (Flow-Volume) or V/T (Volume-Time) Graph by default in the FVC test screen. Select the required option from the drop down menu.
  2. VC Display: You can select to show the Bar Graph or V/T (Volume-Time) Graph by default in the VC test screen.
  3. Test Acceptance: This allows you to manually accept the tests performed, or allow the device to determine test acceptability (automatic).
  4. Graph Scale: This allows you to select the default graph scale.
  5. Posture: You can select to no posture selected, standing or sitting.
  6. Post VC Test: If you have done a VC test in a pre test session and then go to do a Post test on that session then the VC test screen will automatically come up. By selecting ‘off’ in the drop down list you will be brought directly into the FVC test screen.
  7. Temperature: By selecting ‘on’ in the drop down list, the device gives the user the option to manually enter the ambient temperature as they go into the VC or FVC test screens.

Database

This allows you to manage the available memory on the device. The Management tab tells you how much subject and test session memory has been used up. As with all memory after a period of time and repeated use the memory becomes fragmented. Because of this the total available memory is not being used. In order to correct this, select the Defragment option. This process may take several minutes to complete.


The Deletion option allows the user to delete sessions. By selecting the relevant box the session will be deleted from the device after being Printed. (Either a print to an internal printer or sent to Vitalograph Reports).

You are also given the option to ‘Select Test Session(s)’ for deletion, or ‘Delete Subject(s)’ from the device by pressing the relevant button using the touch panel LCD.


Calibration

The Vitalograph ALPHA Touch 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.


Select the Calibration Options menu. You are presented with four options:

Calibration
  1. Select Calibration from the Calibration screen.
  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 ‘C’ key to exit the Calibration screen.
  4. If a Calibration report is required select the Report option.

    Note: An Accuracy check must be done on the same day as the device is calibrated.
Precision Syringe:
  1. Select Precision Syringe from the Calibration screen.
  2. Select the volume of the calibrated syringe you are using from the drop down list.
  3. Enter the syringe reference number using the touch panel keypad.
  4. Press ‘Enter’ to save the new volume entered and return to the Calibration screen. Press ‘C’ to cancel the changes made and return to the Calibration screen.

Linearity Check
  1. Select Linearity from the Calibration screen.
  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. Enter the environmental data if prompted to do so.
  4. Press the ‘Enter’ key to bring you into the Linearity Check screen.
  5. 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 ‘C’ key to exit the Linearity Check screen.
  6. Repeat for the slow rate three times in total.
  7. Repeat the procedure outlined in step e 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.
  8. Repeat for the medium rate three times in total.
  9. Repeat the procedure outlined in step e 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.
  10. Repeat for the fast rate three times in total.
  11. When all the manoeuvres are complete press ‘Enter’ for the result.
  12. If a Linearity Check report is required select the Report option.

Accuracy Log
  1. Select Accuracy Log from the Calibration screen. The accuracy log contains a record of all the accuracy checks done on the device.
  2. There are three options
  3. Press ‘C’ to return to the Calibration screen.

Settings

This allows you to adjust the settings of the device. The following options are available in the Device Settings screen:


Date/Time

There are two tabs in this screen for the time and date.

  1. In order to change the time, scroll the hours and minutes to the required settings by pressing the arrows on the touch panel LCD.
  2. The time format can be changed from 24 hour to 12 hour by switching On/Off the ’24 Hour Format’ option.
  3. In order to change the date, scroll the day, month and year to the required settings by pressing the arrows on the touch panel LCD.


Units
The units used can be modified by selecting the alternative option available on the drop down list:


Sound Options


This allows you to turn off and on the Key, Flow, Error and Welcome sounds on the device. Simply select the on/off key for the specific sound.

Adjust the volume by pressing the ‘-/+’ on the touch panel LCD.



Power Save Options


In order to improve battery life you can configure the device to dull the display after 3 minutes. This can be switched on or off.



Incentive

The Incentive Device is used as an aid in testing of children.
  1. To change the incentive device to be used in testing, select an alternative for the Incentive Device drop down list. A preview of the incentive will appear on the screen.
  2. The % of predicted can be modified using the on-screen keyboard. The value entered must be between 80-150.
  3. The % of Best Test value can be modified using the on-screen keyboard. The value entered must be between 80-150.


Parameters


This gives a complete list of the test parameters that can be reported (and printed) for a test session. To select/unselect a parameter check/uncheck the relevant check boxes. Additional parameters are available by selecting the additional index tabs.


The following list supplies definitions of the parameters:

Parameter

Definition

VC

Vital capacity (L)

IVC

Inspiratory vital capacity (L)

FIVC

Forced inspiratory vital capacity (L)

FVC

Forced vital capacity (L)

FEV.5

Forced expiratory volume after 0.5 seconds (L)

FEV.75

Forced expiratory volume after 0.75 seconds (L)

FEV1

Forced expiratory volume after 1 second (L)

FEV3

Forced expiratory volume after 3 seconds (L)

FEV6

Forced expiratory volume after 6 seconds (L)

PEF L/s

Peak expiratory flow (L/sec)

PEF L/min

Peak expiratory flow (L/min)

FEF0.2-1.2

(F02-12)

Mean forced expiratory flow in the volume interval between 0.2 and 1.2 L of the test (L/sec)

FEF 25-75

(F2575)

Maximal mid expiratory flow: the mean FEF in the time interval between 25% and 75% of the FVC (L/sec)

FEF 75-85

(F7585)

Forced late expiratory flow: the mean FEF in the time interval between 75% and 85% of the FVC (L/sec)

FEF 25

Forced expiratory flow at 25% of the FVC (L/sec)

FEF 50

Forced expiratory flow at 50% of the FVC (L/sec)

FEF 75

Forced expiratory flow at 75% of the FVC (L/sec)

FIV1

Forced inspiratory volume after 1 second (L)

PIF L/s

Peak inspiratory flow (L/sec)

FIF 25

Forced inspiratory flow at 25% of the FVC (L/sec)

FIF 50

Forced inspiratory flow at 50% of the FVC (L/sec)

FIF 75

Forced inspiratory flow at 75% of the FVC (L/sec)

MVVind

Maximum voluntary ventilation indirectly calculated from the FEV1 (L/min)

FMFT

Forced mid-expiratory flow time (sec)

FET

Forced expiratory time (sec)

Vext

Extrapolated volume (L)

FRC

Functional residual capacity (L)

TV

Tidal volume (L)

RV

Residual volume (L)

TLC

Total lung capacity (L)

IRV

Inspiratory reserve volume (L)

ERV

Expiratory reserve volume (L)

IC

Inspiratory capacity (L)

Rind

Airways Resistance Indirect measurement.

FIVC/FVC

Ratio FIVC of FVC

FEV.5/FVC

Ratio FEV 0.5 of FVC

FEV1/FEV6

Ratio FEV1 of FEV6

FEV1/FVC

Ratio FEV1 of FVC

FEV1/VC

Ratio FEV1 of VC

FEV1/PEF

FEV1 divided by PEF (L/L/s)

FEV3/VC

Ratio FEV3 of VC

FEV3/FVC

Ratio FEV3 of FVC

FEF 25-75/FVC

(F2575/F)

Ratio FEF 25–75 of FVC

FIV1/FVC

Ratio FIV1 of FVC

FIV1/FIVC

Ratio FIV1 of FIVC

FIF50FEF50

Ratio FIF 50% of FEF 50%

FEV75/FVC

Ratio FEV 0.75 of FVC

FEV1/FIVC

Ratio FEV1 of FIVC

FEV1/IVC

Ratio FEV1 of IVC

FEV1R

FEV1 divided by the largest VC from the VC or FVC manoeuvre.

Vext/FVC

Ratio extrapolated volume of FVC

PIF L/min

Peak inspiratory flow (L/min)

Lung Age

Lung age will be displayed if the date of birth, height, population group and smoking information have been entered.  Lung age will only be shown if the measured FEV1 value is less than the lower limit of the predicted normal value for FEV1.

Subject Options

The following options are available in the Subject Options screen:

  1. Primary View: The default view in which the subjects are listed can be set to either name or ID. Select the required option from the drop down list.
  2. The device can be password protected, by setting the on/off button to the on position. The password can be changed using the touch panel keypad
  3. The facility to enter Smoking History, Population Group and Weight can be configured on or off when creating a new subject on the device. To change the setting simply select the on/off button on the touch panel keypad.

Smart Options

The Smart Options allow you to set up the device to follow a set sequence of operation on power up. In the Smart Options screen you can set Smart on or off by selecting from the drop down list. When set to on you are given four options:

  1. After Power Up: You can either configure the device to go to the Main Menu or go to the Subject screen after power up. Select the required option from the drop down list.
  2. After Subject: You can configure the device to go to VC Test, FVC Test or the Main Menu after selecting a subject. Select the required option from the drop down list.
  3. After VC: You can configure the device to go to FVC or the Main Menu after performing a VC test. Select the required option from the drop down list.
  4. After FVC: You can configure the device to go to POST mode, Print the test or go to the Main Menu after performing an FVC test. Select the required option from the drop down list.

Report Options

The Report Options screen allows you to set the Report Content and the Report Method.


Report Content

The information printed on the session reports can be configured to suit individual requirements. The following can be configured in the report:

  1. Table: The device can be configured to show the results for the best test only (Best 1) or the three best tests (Best 3). Select the required option from the drop down list.
  2. Normal Comparison: In the session table of results either the % of Predicted value or the SDS (Standard Deviation Score) will be printed. Select the required option from the drop down list.
  3. Test QA: The session report can be configured to show the test QA. Select the required option to turn this on or off.
  4. Interpretation: The session report can be configured to show the device suggested interpretation. Select the required option to turn this on or off.
  5. Comments Header: The session report can be configured to show a Comments Header. Select the required option to turn this on or off.
  6. Ambient Conditions: The session report can be configured to show the Ambient Conditions. The ambient conditions (Humidity, Pressure and Altitude) are those entered when performing an accuracy check or calibration update.  Select the required option to turn this on or off. 
  7. V/T Size: The Volume/Time graph can be changed from standard to ATS/ERS 2005 (ATS) requirements. Select the required option from the drop down list.
  8. F/V Size: The Flow/Volume graph can be changed from standard to ATS/ERS 2005 (ATS) requirements. Select the required option from the drop down list.
  9. V/T Graph: The session report can be configured to show the V/T (Volume vs. Time) graph. Select the required option to turn this on or off.
  10. F/V Graph: The session report can be configured to show the F/V (Flow vs. Volume) graph. Select the required option to turn this on or off.
  11. Trend Graph: The session report can be configured to show the trend graph. Select the required option to turn this on or off. The trend graph can only be printed when the trend graph option and the configurable report option are selected.


Report Method

The ALPHA Touch can print to the internal printer or Vitalograph Reports. The following options are available:

  1. Report: Select the option to either Send To PC or Internal Printer from the drop down list.
  2. Content: The report can be set to the default report or the configurable report option. Select the required option from the drop down list.
  3. Colour: The printout can be set to Colour or Black & White. Select on for a colour printout (print via a P.C), and off for black & white.


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 ALPHA Touch connected to your PC via a USB cable.

6.10 Fitting a New Paper Roll

The Vitalograph ALPHA Touch 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 Touch.
  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 Touch 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 four button 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.

Printer Roll Instructions

Figure 02


 

7. Cleaning Instructions

7.1. Cleaning and Low Level Disinfection of the Vitalograph ALPHA Touch

The parts of the Vitalograph ALPHA Touch 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 Cleaning/Disinfection Methods

Part Clean/Low Level Disinfection Recommended Cleaning/Low Level Disinfection
Case Exterior Clean Wiping with a 70% isopropyl alcohol impregnated cloth.

Note: Ensure isopropyl alcohol does not come in contact with the screen.

Warning: Paper tear bar contains sharp edges. Users should take care not to cut/scrape their fingers.

Flowhead Tube Clean
Flowhead Body Clean

See section 7.2 for disassembling and cleaning of flow head.

See section 7.3 for reassembling and low level disinfection of the flowhead

Fleisch Element Clean
Flowhead Cone Clean & Low Level Disinfection
Flowhead End Cap Clean & Low Level Disinfection
Flow Conditioning Meshes Clean & Low Level Disinfection
ScreenClean Lightly wipe the surface with cotton pad or other soft material. NOTE: DO NOT use chemicals such as acetone, toluene, ethanol or isopropyl alcohol. DO NOT wipe in a circular motion. Strokes should be either up/down or over/back.

7.2. Disassembling and Cleaning of 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. 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.