alpha Touch Model 6000 User Training Manual Issue 5

6/24/13

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UK Sales Vitalograph Ltd. Maids Moreton, Buckingham, MK18 1SW, England Phone: (01280) 827110 Fax: (01280) 823302 e-mail: [email protected] www.vitalograph.co.uk Export Sales Vitalograph Ltd. Maids Moreton, Buckingham, MK18 1SW, England Phone: +44 1280 827120 Fax: +44 1280 823302 e-mail: [email protected] www.vitalograph.eu Vitalograph GmbH Rellinger Straße 64a, 20257 Hamburg, Germany Phone: (040) 54 73 91-0 Fax: (040) 547 391 40 e-mail: [email protected] www.vitalograph.de Vitalograph Inc. 13310 West 99th Street, Lenexa, Kansas 66215, U.S.A. Phone: (913) 730-3200 Fax: (913) 730-3232 e-mail: [email protected] www.vitalograph.com Vitalograph (Irl.) Ltd. Gort Road Business Park, Ennis, Co. Clare, Ireland Phone: (065) 6864100 Fax: (065) 6829289 e-mail: [email protected] www.vitalograph.ie © Copyright Vitalograph 2013 Current Edition (Issue 5) Cat. No. 07586 is a registered trademark

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Table of Contents 1. DESCRIPTION OF THE VITALOGRAPH ALPHA TOUCH 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 i. Checks to make before performing a Test Session ii. Performing a VC Test iii. 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 i. When to Check Accuracy 9. CONFIGURATION OPTIONS i. Test Preferences ii. Database iii. Calibration iv. Settings v. Subject Options vi. Smart Options vii. 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

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Figure 01

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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.

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: Touch screen color display or buttons Clear sounds for audio feedback Choice of child incentive displays Fully customisable report format Automatic download of new subjects from Spirotrac 10,000 subject test memory Automatic upload of all test data to Spirotrac Pre/post bronchodilator comparison Choice of predicted values and languages Diagnostic interpretation options Lung age for adults and adolescents Real-time test quality prompts Vitalograph PC software included Stylus Can enter subject details on device Very high accuracy, linearity and stability Integral printer for instant results or printing to the Vitalograph Report Utility Simple cleaning. The flowhead completely dismantles for washing, disinfecting or even autoclaving

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4. GETTING THE VITALOGRAPH ALPHA TOUCH READY FOR 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.

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 recharging the batteries via USB. 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: 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. 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. vitalograph.eu/downloads/117/user-training-manual

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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, hi-light 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 or SafeTway 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.

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: a. Sit upright, fit the nose clip and relax. b. Keep the flowhead away from your mouth. c. Inhale as deeply as possible, hold your breath, then insert the mouthpiece carefully into your mouth, clamping it gently between your teeth. d. Seal your lips around the mouthpiece and keep your tongue down. e. Exhale for as long as possible. It is vital that the operator encourages the subject to keep exhaling to ensure all air is expelled. f. 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. vitalograph.eu/downloads/117/user-training-manual

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This method cannot be used when the Volume bar graph is selected as the display. a. Sit upright, fit the noseclip and relax. b. Insert the mouthpiece carefully into your mouth, clamping it gently between your teeth. c. Seal your lips around the mouthpiece and keep your tongue down. d. Breathe in and out normally. This is tidal breathing. When you are happy that the subject has achieved steady tidal breathing, continue with: e. Exhale for as long as possible. It is vital that the operator encourages the subject to keep exhaling to ensure all air is expelled. f. Inhale as deeply as possible (speed is not important) and when fully inhaled. g. 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. 4. Repeat the blow three times or more to obtain good test quality. 5. 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.

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: a. Sit upright, fit the noseclip and relax. b. Hold the unit, keeping it away from your mouth. c. Inhale as deeply as possible, hold your breath, then insert the mouthpiece carefully into your mouth, clamping it gently between your teeth. d. Seal your lips around the mouthpiece and keep your tongue down. e. 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) f. If inspiratory indices are selected, then inhale as quickly as possible. g. Listen for two beeps. This indicates that Vitalograph ALPHA Touch is ready for the next blow. Method 2: a. Sit upright, fit the noseclip and relax. vitalograph.eu/downloads/117/user-training-manual

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b. Insert the mouthpiece carefully into your mouth, clamping it gently between your teeth. c. Seal your lips around the mouthpiece and keep your tongue down. d. Breathe in and out normally. This is called tidal breathing. When you are happy that the subject has achieved steady tidal breathing, continue with: e. Inhale as deeply as possible f. 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) g. Inhale fully as quickly as possible h. Return to tidal breathing, i.e. breathe in and out normally again.

4. 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. 5. Repeat the blow three times or more to obtain good test quality. 6. To view results select the results tab. You can view the results for each blow by selecting the up/down arrows on the bottom of the screen. If any of the parameters are below the Lower Limit of Normality (LLN), then they will be displayed in red, provided the subject age, height and gender are entered. To view the graph of the blow select the graph button on the bottom of the screen. You can choose to manually accept or reject a blow using the drop down list for User Acceptability on the top right of the screen. You can view the trend graph by selecting the trend button on the bottom left of the screen. 7. 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.

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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: a. Select ‘Select Subject from List’. b. 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. c. Select the subject you wish to perform the Post test on, and the Select Test Session screen will appear. Select the test session. i. Note: The words Pre, VC or FVC or a combination of these will appear after the session ID. ii. If the word Pre appears then a POST test session has already been performed on this pre session. iii. If the word VC appears then a VC test has been done as part of the pre-session. iv. If the word FVC appears then an FVC test has been performed as part of the pre-session. d. 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: vitalograph.eu/downloads/117/user-training-manual

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a. 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. b. 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. c. 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: a. 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. b. 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. c. 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 o 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. vitalograph.eu/downloads/117/user-training-manual

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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. 6. 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 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 or device has been dropped

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: a. 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. b. VC Display: You can select to show the Bar Graph or V/T (Volume-Time) Graph by default in the VC test screen. c. Test Acceptance: This allows you to manually accept the tests performed, or allow the device to determine test acceptability (automatic). d. Graph Scale: This allows you to select the default graph scale. e. Posture: You can select to no posture selected, standing or sitting. f. 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. g. 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. vitalograph.eu/downloads/117/user-training-manual

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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 Precision Syringe Linearity Accuracy Log Calibration a. Select Calibration from the Calibration screen. b. 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. c. 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. d. 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: a. Select Precision Syringe from the Calibration screen. b. Select the volume of the calibrated syringe you are using from the drop down list. c. Enter the syringe reference number using the touch panel keypad. d. 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 a. Select Linearity from the Calibration screen. b. 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. c. Enter the environmental data if prompted to do so. d. Press the ‘Enter’ key to bring you into the Linearity Check screen. e. 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. f. Repeat for the slow rate three times in total. g. 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. vitalograph.eu/downloads/117/user-training-manual

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h. Repeat for the medium rate three times in total. i. 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. j. Repeat for the fast rate three times in total. k. When all the manoeuvres are complete press ‘Enter’ for the result. l. If a Linearity Check report is required select the Report option. Accuracy Log a. Select Accuracy Log from the Calibration screen. The accuracy log contains a record of all the accuracy checks done on the device. b. There are three options To print the complete accuracy log press “Print All”. To print a log of the last 30 accuracy tests done, press “Print Last 30”. To view the accuracy log, press “View”. c. 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 Units Sound Options Power Save Options Incentive Parameters

Date/Time There are two tabs in this screen for the time and date. a. In order to change the time, scroll the hours and minutes to the required settings by pressing the arrows on the touch panel LCD. b. The time format can be changed from 24 hour to 12 hour by switching On/Off the ’24 Hour Format’ option. c. 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: Metric US (Imperial)

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. vitalograph.eu/downloads/117/user-training-manual

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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. a. 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. b. The % of predicted can be modified using the on-screen keyboard. The value entered must be between 80-150. c. 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)

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PEF L/min

Peak expiratory flow (L/min)

FEF0.2-1.2

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

(F02-12) FEF 25-75 (F2575) FEF 75-85 (F7585)

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

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)

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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

Ratio FEF 25–75 of FVC

(F2575/F) 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.

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Subject Options The following options are available in the Subject Options screen: a. 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. b. 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 c. 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: a. 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. b. 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. c. 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. d. 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: a. 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. b. Normal Compensation: 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. c. Test QA: The session report can be configured to show the test QA. Select the required option to turn this on or off. d. Interpretation: The session report can be configured to show the device suggested interpretation. Select the required option to turn this on or off. e. Comments Header: The session report can be configured to show a Comments Header. Select the required option to turn this on or off. f. 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. g. 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. h. 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. i. 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. vitalograph.eu/downloads/117/user-training-manual

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j. 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. k. 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 an internal printer or Vitalograph Reports. The following options are available: a. Report: Select the option to either Send To PC or Internal Printer from the drop down list. b. Content: The report can be set to the default report or the configurable report option. Select the required option from the drop down list. c. 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.

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Figure 02

7. CLEANING INSTRUCTIONS 7.1. Cleaning and Disinfecting the Vitalograph ALPHA Touch A new mouthpiece (either SafeTway or BVF) should be used for each subject. A delay of at least 5 minutes should be allowed between subjects to allow settling of previously aerosolized particles in the measuring device. It is recommended that the flowhead be regularly cleaned according to the guidelines of the user’s facility. In the event of visible contamination of the flowhead cones or flowhead element, they should be cleaned or disinfected as described in the accompanying table. The flowhead conditioning meshes should also be replaced in the event of damage, or if visibly contaminated. The frequency of cleaning and disinfecting is dependent on the Facility’s Risk Assessment, usage, and test environment, but it should be at least monthly or every 100 subjects (500 blows). It is recommended that the flowhead - flowhead complete and flowhead connection tube-be replaced annually. Refer to Figure 3 for identification of parts

Table of Materials Used & Cleaning/Disinfection Methods This listing of materials used is given to provide users with information to allow the assessment of other cleaning and disinfecting procedures available in the facility on this device. Part

Material

Clean/ Disinfect

Autoclave Recommended Disinfectants Possible?

Case Exterior

ABS

Clean

No

Flowhead Tube

Silicone Rubber

Clean

Viable

Wiping with a 70% isopropyl alcohol impregnated cloth provides a suitable form of cleaning and low-level disinfection. This may be preceded by cleaning with an anti-static foam cleaner if necessary. 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/scrap their fingers.

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