Compact Model 6600 User Manual Issue 1

Vitalograph Compact User Manual 07330 Issue 1

Vitalograph Ltd., Maids Moreton, Buckingham, MK18 1SW, England Phone: (01280) 827110 Fax: (01280) 823302 e-mail: [email protected] Vitalograph GmbH, Jacobsenweg 12, 22525 Hamburg, Germany Phone: (040) 54 73 91-0 Fax: (040) 547 391 40 e-mail: [email protected] Vitalograph Inc., 8347 Quivira Road, Lenexa, Kansas 66215, U.S.A. Phone: (913) 888-4221 Fax: (913) 888-4259 e-mail: [email protected] Vitalograph (Irl.) Ltd., Gort Road Business Park, Ennis, Co. Clare, Ireland Phone: (065) 6864100 Fax: (065) 6829289 e-mail: [email protected] Internet: www.vitalograph.com © Copyright Vitalograph 2004 Current Edition (Issue 1) Cat. No. 07330 Vitalograph is a registered trademark

Copyright Vitalograph 2004

Table of Contents DESCRIPTION OF THE VITALOGRAPH COMPACT

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MAIN COMPONENTS OF THE VITALOGRAPH COMPACT

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FEATURES OF THE VITALOGRAPH COMPACT

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GETTING THE VITALOGRAPH COMPACT READY FOR USE

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OPERATING THE VITALOGRAPH COMPACT

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LOGGING IN ENTERING OR SELECTING SUBJECT INFORMATION CREATING A NEW SUBJECT Creating a New Subject for a Non-advanced User Creating a New Subject for an Advanced User. SELECTING A SUBJECT FROM THE DATABASE PERFORMING A TEST SESSION Checks to Make before Performing a Test Session Performing an FVC Test Performing a Single Breath Test Continued Using the Incentive Device PERFORMING CLOSED CIRCUIT SPIROMETRY PERFORMING A POST TEST SESSION PRINTING AND VIEWING TEST SESSIONS Printing a Test Session Viewing a Test Session MODIFYING SUBJECT INFORMATION Modifying Subject Information for a Non-advanced user Modifying Subject Information for an Advanced User. CHECKING ACCURACY VIEWING/PRINTING THE ACCURACY LOG WHEN TO CHECK ACCURACY

2 3 3 4 6 7 8 8 8 11 12 15 18 19 20 20 21 21 24 25 26 27

DELETING SUBJECT INFORMATION AND/OR TEST RESULTS. 27 POPULATION GROUPS AND NORMAL SETS

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TEST CONFIGURATION

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VITALOGRAPH COMPACT CONFIGURATION

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REPORT/PRINTER OPTIONS

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FITTING A NEW PAPER ROLL

42

USER CONFIGURATIONS

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CLEANING INSTRUCTIONS

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CLEANING AND DISINFECTING THE VITALOGRAPH COMPACT DISASSEMBLING THE VITALOGRAPH COMPACT REASSEMBLING THE FLEISCH FLOWHEAD

44 47 48

FAULT FINDING GUIDE

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CUSTOMER SERVICE

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CONSUMABLES AND ACCESSORIES

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EXPLANATION OF SYMBOLS

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OTHER LABELS

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TECHNICAL SPECIFICATIONS

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CE NOTICE

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FDA NOTICE

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DECLARATION OF CONFORMITY

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GUARANTEE

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BUTTONS AND ICONS USED IN COMPACT

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Vitalograph Compact User Manual 07330 Issue 1

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Copyright Vitalograph 2004

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DESCRIPTION OF THE VITALOGRAPH COMPACT The Vitalograph COMPACT is a desktop spirometer designed for use by trained professionals in the doctor’s office, clinic, hospital department, clinical trials, etc. for measuring and archiving tests on human subjects. Demographic data are uploaded or entered via a touchscreen and stored, together with spirometry test data. Current test data and the subject’s history 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 a service agent. To access the About box: 1. Press the More button on the Home screen. 2. Press the About button.

MAIN COMPONENTS OF THE VITALOGRAPH COMPACT A B C D

Vitalograph COMPACT device LCD/Touchscreen Flowhead Printer

FEATURES OF THE VITALOGRAPH COMPACT The Vitalograph COMPACT’s features include: • • • • • •

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Very high accuracy, linearity and stability Automatic trending Extremely simple to operate touchscreen with extra-large buttons Integral printer for instant results or optional external printing Automatic 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.

GETTING THE VITALOGRAPH COMPACT READY FOR USE 1. Attach the flowhead to the Vitalograph COMPACT 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 remove bubble wrap from each side of paper roll. 3. Only use the Vitalograph COMPACT 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 10 volts DC. 4. Connect the jackplug from the power supply into the socket on the rear of the Vitalograph COMPACT. The IEC connector on the mains lead plugs into the socket on the power supply. Plug the mains plug into a suitable socket, operate the On/Off switch on the rear of the instrument and the Vitalograph COMPACT is ready for use. 5. A helpful demonstration will automatically start when the COMPACT is powered up for the first time. On subsequent powerup the demonstration will not start automatically. To access the demonstration again press the Help button on the Home screen. Note: A complete list of the buttons and icons used in this device is available at the back of this Manual.

OPERATING THE VITALOGRAPH COMPACT Logging In The COMPACT can be configured so that a user must login during power-up. (See section User Configurations). If this option is selected, 2

the user is presented on power-up with a login screen showing a list of users stored in the database. There are two options available: 1. Select the required username from the list-box and continue to login by pressing the Return button. 2. If the required username is not on the list, then you can create one by pressing the New User button. Enter the username using the on-screen keyboard. When you have entered the username you can do one of two things: a. Save the username to the database and return to the login screen by pressing either the Home or Return buttons. b. Do not save the changes and return to the login screen, by pressing the Back button.

or

Entering or Selecting Subject Information In order to save test sessions to the database, a current subject must first be created or selected for test. You can: • Enter subject information for a new subject as described in the Creating a New Subject section. This information is stored on the database. Or •

Recall a previously entered subject from the database as described in the Selecting a Subject from the Database section.

Creating a New Subject There are 2 methods available to the user for creating a New Subject: • Creating a new subject for a non-advanced user. • Creating a new subject for an advanced user.

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Note: Refer to section User Configurations for instructions on how to set a user to advanced and non-advanced. To access the New Subject screen, select the New Subject button from the Home screen. Creating a New Subject for a Non-advanced User

After entering the New Subject screen, you are presented with a series of dialog boxes in which you can enter information. Once you are ready to move onto the next dialog box, press the Enter key on the keyboard. These dialog boxes appear one at a time in the following order:

1. Enter Last Name using the on-screen keyboard (Last Name)

2. Enter First Name using the on-screen keyboard 3. Enter Date of Birth using

the

on-screen

keyboard

4. Enter Male/Female by selecting the relevant option

(First Name)

(Date of Birth) / (Male/Female)

5. Enter Height using the on-screen keyboard

(Height)

Note: The next dialog box will appear automatically if the maximum information allowed for a field has been entered. When the subject’s height has been entered, a dialog box containing the subject ID will appear at the top of the screen. This ID is created by the COMPACT unit, but it can be modified by the user if required. There are four options available to you at this stage. You can: 1. Save the new subject to the database and return to the Home screen by pressing the Home button.

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2. Return to the Home screen without saving the new subject to the database by pressing the Back button. 3. Save the new subject to the database and perform a test session by pressing either the Enter key on the LCD keyboard or the Return button. 4. Enter additional subject information by pressing the Forward button. This option will allow you to enter: a. Population group from a drop down list b. Weight using the on-screen keyboard 5. There are now two options available: a. Return to the New Subject screen by pressing the Back button. b. To modify the smoking information, press the Forward button. This will allow you to modify the smoking status by selecting the relevant option from the following: i. Non-smoker

ii.

Current smoker

iii.

Ex-smoker

For a Current smoker, you will need to enter the: i. Cigs. per day

ii.

Year started

For an Ex-smoker, you will need to enter the: i. Cig. per day

ii.

Year started

iii.

Year quit

c. If you suspect the subject has COPD, check the COPD check box. d. Enter subject comments in the field provided using

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the on-screen keyboard 6. You can return to the New Subject screen by pressing the Back button twice. (X2) Creating a New Subject for an Advanced User.

After entering the New Subject screen, you are presented with a series of dialog boxes.

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Enter data in the fields as required. a. Enter the subject ID using the on-screen keyboard b. Enter last name using the on-screen keyboard c. Enter first name using the on-screen keyboard d. Enter the population group from a drop down list e. Enter date of birth using keyboard f.

the

(Subject ID) (Last Name) (First Name) (Population Group)

on-screen

Enter gender by selecting the relevant option

(Date of Birth)

/ (Male/Female)

g. Enter height using the on-screen keyboard Height

h. Enter weight using the on-screen keyboard Weight

2. Once you are ready to move onto the next field press Enter on the keyboard. Note: The curser will move on automatically if the maximum information allowed for a field has been entered. Any or all fields can be left blank also. 3. When you are satisfied with the data you have entered, you can do one of four things: 6

a. Save the new subject to the database and return to the Home screen by pressing the Home button. b. Return to the Home screen without saving the new subject to the database by pressing the Back button. c. Save the new subject to the database and perform a test session by pressing the Return button. Note: The unit will only allow you to perform a test if a subject ID has been created. If you did not enter a subject ID, the unit will automatically create one. You can modify this if required. c. Enter the smoking information screen by pressing the Forward button. Refer to section Creating a New Subject for a Non-advanced User for entering information here.

Selecting a Subject from the Database If a subject has previously been created, the details will be stored in the database. Follow these steps to recall a subject from the database. 1. To access the Recall Subject screen, press the Recall Subject button on the Home screen. 2. All subjects are listed. It is possible scroll down through the list by pressing the up/down arrows on the list box. 3. You can list the subject by Name or ID by making the relevant selection. 4. Highlight the subject you require by making a selection in the list box. The subject will now appear in the dialog box beside the list box. You can now do one of three things: a. Make the selection the current subject and return to the Home screen by pressing the Home button.

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or

Note: If the selected subject has a name entered it will appear at the status bar on the bottom of the screen. If the selected subject has no name entered the text ‘No name entered’ will appear on the status bar. b. Cancel the selection and return to the Home screen by pressing the Back button. c. Make the selection the current subject and edit the subject’s information by pressing the Return button. Refer to section Modifying Subject Information on how to edit subject information. Carry out a test session on the selected subject by pressing the Return button again.

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 COMPACT unit was checked recently. (Refer to section on Checking Accuracy) 2. Check that the required Save Options, FVC Test Type and Test Indices are selected. (Refer to section on Test Configuration). 3. Check that a subject is selected and that all the required demographic information is entered for the subject. (Refer to section on Selecting a Subject from the Database). Note: If a name has been entered, then that name will appear in the status bar. If no name has been entered, then ‘No name entered’ will appear on the status bar. Performing an FVC Test

There are two test types that can be performed using the COMPACT. These are: • Single Breath Test • Closed Circuit Spirometry Refer to section on Test Configuration for selecting the test type. 8

Performing a Single Breath Test

Follow these steps to perform a single breath test: 1. Press the Perform Test button on the Home screen.

Note: If no subject has been selected from the database then you will be presented with a list of all subjects. There are two options here. You can: a. Select the subject required and press the Enter key. The subject’s demographic information will then be displayed. Review this and change if required. Press the Enter key to display the testing screen. b. Press the Enter key without selecting any subject from the database. The COMPACT unit will automatically create a subject ID before displaying the testing screen. Depending on the Test Configuration settings, you may be presented with a testing screen to either perform a VC or an IVC test. Note: If neither VC or IVC is selected in the Test Configuration settings, then the testing screen will not be displayed. Perform a VC Test

1. Wait for the Exhale to Begin icon to appear. This indicates that the COMPACT unit is ready to accept a blow. 2. Read the following instructions to the subject so that testing is performed properly: a. Stand up. b. Keep the flowhead away from your mouth. c. Inhale as deeply as possible and insert the mouthpiece into your mouth, clamping it between your teeth. d. Close your lips around the mouthpiece. e. Exhale normally for as long as possible.

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3. If you are prompted to accept the test, press the Cancel button to reject the test or the Enter key to accept the test. 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 to perform another VC test if required. Note: A maximum of 12 VC tests can be performed in one session. 5. After performing the VC tests, you can do one of four things: a. Return to the Home screen by pressing the Home button. This will finish the test session. b. Return to the Subject Select screen by pressing the Back button. This will end the test session. c. Perform a Single Breath Test by pressing the FVC button. d. Perform a Post test by selecting the Post button. Note: Refer to the section on Performing a Post Test Session Perform an IVC Test

1. Wait for the Exhale to Begin icon to appear. This indicates that the COMPACT unit is ready to accept a blow. 2. Read the following instructions to the subject so that testing is performed properly: a. Stand up. b. Insert the mouthpiece into your mouth and, clamping it between your teeth. c. Close your lips around the mouthpiece. d. Breathe in and out normally. This is tidal breathing.

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When you are happy that the subject has achieved steady tidal breathing, continue with: e. Exhale as deeply as possible. f. Inhale as much as possible (speed is not important) and when fully inhaled g. Return to tidal breathing i.e.: Breathe in and out normally again. 3. If you are prompted to accept the test, press the Cancel button to reject the test or the Enter key to accept the test. The IVC values recorded for the blow are displayed in the table. The best IVC value for the current session and the Lower Limit of Normality (LLN) are also displayed. 4. Repeat to perform another IVC test if required. Note: A maximum of 12 IVC tests can be performed in one session. 5. After performing the IVC tests, you can do one of four things: 1. Return to the Home screen by pressing the Home button. This will end the test session. 2. Return to the Subject Select screen by pressing the Back button. This will end the test session. 3. Perform a single breath test by pressing the FVC button. 4. Perform a Post test by pressing the Post button.

Note: Refer to the section on Performing a Post Test Session Performing a Single Breath Test Continued

Note: If you have not selected either of the VC or IVC check boxes in the Test Indices selection screen, you will be brought directly into the FVC test screen.

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1. Press the FVC button in the VC or IVC screens to enter the Single Breath Test screen. To perform a Single Breath Test: a. Wait for the Exhale to Begin icon to appear. This indicates that the COMPACT unit is ready to accept a blow. b. Read the following instructions to the subject so that testing is performed properly: i. Stand up. ii. Keep the flowhead away from your mouth. iii. Inhale as deeply as possible and inset the mouthpiece into your mouth, clamping it between your teeth. iv. Close your lips around the mouthpiece. v. Exhale as much and as quickly as possible and try to keep exhaling for at least 6 seconds. vi. If inspiratory indices are selected, then inhale as quickly as possible. 2. If you are prompted to accept the test, press the Cancel button to reject the test or the Enter key to accept the test. The FVC and FEV1 values recorded for the blow are tabulated. The best FVC and FEV1 values for the current session and the Lower Limit of Normality (LLN) are also displayed. 3. Repeat to perform another Single Breath Test if required. Note: A maximum of 12 Single Breath tests can be performed in one session. Using the Incentive Device

The Incentive Device is used as an aid in the Single Breath Test of children. To access this: 1. Press the Incentive button on the top of the screen. Note: You must wait for the Exhale to Begin icon to appear before a blow can be performed.

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2. To view the results for the individual blows associated with the test session, press the Results tab. The blows are listed in order of ranking. The best blow being listed first. Predicted values are selected for the selected indices. The predicted number will be displayed if the date of birth, height, gender and population group are entered. 3. To view the next ranked blow, press the Arrow button. 4. To view the trend graph for the current subject, press the Trend tab. There is an option here to switch between trending. Trending for all test sessions performed will be shown by default when you select the Trend tab. This is a seventy-year trend of the best FEV1 value. A predicted line is shown from the 25–70th year, if the subject’s demographic information is entered. a. In order to view the trend of the last ten test sessions, press the Ten Point Trend button. b. To switch back to the full trend, press the Full Trend button. 5. Press the Info tab to view the quality information and the interpretation of the session results. The reproducibility information for FVC, FEV1 and PEF is displayed if at least two tests are performed. If the reproducibility criteria are met, then a message saying ‘GOOD test session’ is displayed. No reproducibility information will be displayed if the manual save option is selected. Refer to the Test Configuration section.

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1. Press the Interpretation button to view the suggested interpretation of the results. Interpretation will be displayed if the height, date of birth and population group are entered for the subject. There also needs to be a measured value of FEV1. 2. Press the COPD Risk button to view the COPD risk. This calculates a subject’s risk of developing COPD within the next 10 years, and also the risk if the subject stopped smoking. COPD risk will be displayed if the date of birth, gender and current smoking information has been entered. There also needs to be a measured value of FEV1. 3. Press the COPD Number button to view the COPD score. The COPD number is the measured FEV1 as a percent of the value compared with a reference population of people without lung disease. This is used as a method of categorising the severity of airway obstruction in subjects with COPD. Most lung damage is permanent, so the initial COPD number is unlikely to improve. However, if it remains close to constant, it is a positive sign that the subject’s lungs are not suffering further deterioration. The number will be displayed if the date of birth, height and population group have been entered and the COPD check box has been selected for the subject. 4. To print the COPD number, press the Print COPD button. 5. In order to view the predicted lung age, press the Lung Age button. 6. After performing the Single Breath Tests, you can do one of four things: 14

a. Return to the Home screen by pressing the Home button. This will end the test session. b. Return to the Subject Select screen by pressing the Back button. This will end the test session. c. Print the test session by pressing the Print button. This will end the test session. d. Perform a Post test by pressing the Post button. Note: Refer to the section on Performing a Post Test Session

Performing Closed Circuit Spirometry Follow these steps to perform Closed Circuit Spirometry: 1. Press the Perform Test button on the Home screen. Note: If no subject has been selected from the database, then you will be presented with a list of all subjects. There are two options here. You can: a. Select the subject required. Press the Enter key and the subject’s demographic information will be displayed. Review this and change if required. Press the Enter key to bring you onto the testing screen. b. Press the Enter key without selecting any subject from the database. The COMPACT unit will automatically create a subject ID and bring you onto the testing screen. 2. If FRC, RV and TLC are selected as indices (refer to the section Test Configuration), then a screen asking you to enter a value for FRC, RV or TLC will appear. Enter a value using the on-screen keyboard. If one value is

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