Gold Standard Model 2160 Plus User Instructions Issue 9

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., 13310 West 99th Street, Lenexa, Kansas 66215, U.S.A. Phone: (913) 888-4221 Fax: (913) 888-4259 e-mail: [email protected] Vitalograph (Ireland) Ltd., Gort Road Business Park, Ennis, Co. Clare, Ireland Phone: (065) 6864100 Fax: (065) 6829289 e-mail: [email protected] www.vitalograph.com  Copyright Vitalograph 1995, 2008 Current Edition (Issue 9) Cat. No. 081037

Vitalograph is a registered trademark

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Table of Contents

Description of the Vitalograph Gold Standard Plus...5 Physical Features of the Vitalograph Gold Standard Plus ...5 Using the Vitalograph Gold Standard Plus with Peripheral Devices ...5 Setting Up The Vitalograph Gold Standard Plus...6 Removing the Transit Clamps...6 Connecting to a Power Source ...7 Inserting the Breathing Tube and Mouthpiece or Filter...7 Adjusting the Chart Carrier ...8 Inserting the Vitalogram Chart ...8 Adjusting the Stylus ...9 Powering Up the Gold Standard Plus...9 Configuring the Electronics Module ...10 Setting Up Save ...10 Setting Up Indices ...10 Selecting a Printer ...11 Defining Configuration ...11 Defining Smart...12 About the Software ...13 Checking Accuracy Of The Vitalograph Gold Standard Plus ...13 Checking Accuracy and Linearity...13 Adjusting Calibration...15 Entering Or Selecting Subject Information...16 Entering a New Subject ...16 Selecting an Existing Subject...17 Performing Tests ...18 Instructing the Subject ...18 Performing a VC Test ...18 Performing an FVC Test ...19 Performing a Direct MVV Test ...20 Quality Messages ...21 Test Acceptance...22 Interpreting Test Results...22 Background ...22 Features of the Chart...23 Features of the Flow Rate Calculator...25 Interpreting Results ...26 Performing Post Tests ...35 Performing Post Tests ...35 Viewing Test Results ...35 Viewing the Current Test ...36 Viewing a Test from the Database ...36 Viewing Subject Data from the database ...37 Printing Test Results...37 Connecting to a Printer...37 Printing Results ...38 Deleting Subject Information And/Or Test Results ...39 All subjects ...39 One subject ...39 Using Smart...40 Cleaning The Vitalograph Gold Standard Plus ...41 Cleaning and Disinfecting the Vitalograph Gold Standard Plus ...41 Breathing Tubes ...42 Disposal and Recycling ...43 Consumables/Accessories...43 Spare Parts ...43 Trouble Shooting ...44 3

Technical Specifications ...47 Regulatory Notices ...48 Explanation of Symbols ...48 CE Notice ...48 FDA Notice...49 Declaration of Conformity ...51 Customer Service ...52 Guarantee...53

4

DESCRIPTION OF THE VITALOGRAPH GOLD STANDARD PLUS The Vitalograph Gold Standard Plus is a dry wedge bellows volume displacement spirometer designed to provide a permanent hard copy record of lung function test results. The results can also be stored electronically and viewed, printed or down loaded to a personal computer at a later date. It's robust and reliable design makes it ideal for use in occupational health centres and other high usage environments.

Physical Features of the Vitalograph Gold Standard Plus Top Cover

Stylus Start Point

Keypad/ Display

Chart Carrier

Chart Clip

Stylus Arm Stylus Record Switch

Power Switch

Bacterial/Viral Filter

Breathing Tube Entry

Breathing Tube Figure 1: Front view of the Gold Standard Plus

The Vitalograph Gold Standard Plus’s operational features include: • database of subject information • performs VC and FVC pre- and post tests • test results are time and date stamped (printout only) • stores the results of at least 100 tests • audible incentive device available • printouts of test results available • Smart option can automate actions by bypassing the menus

Using the Vitalograph Gold Standard Plus with Peripheral Devices

h

If you connect additional equipment (not produced by Vitalograph) to the serial interface port, it must conform to VDE0750 Part 1-1 regulations and to your EN specifications, e.g. EN60950 for data equipment, EN60601 for medical equipment. Non medical equipment must be kept outside the subject environment i.e. any area in which intentional or unintentional contact between the subject and parts of the system, or some other persons touching parts of the system, can occur. Medical Devices may be affected by cellular telephones and other personal or household devices not intended for medical facilities. It is recommended that all equipment used near the Vitalograph product comply with the medical electromagnetic compatibility standard and to check before use that no interference is evident or possible. If interference is suspected or possible, 5

switching off the offending device is the normal solution, as is required in aircraft and medical facilities. (Please contact your distributor if you have any queries.)

SETTING UP THE VITALOGRAPH GOLD STANDARD PLUS When you receive the Vitalograph Gold Standard Plus and remove it from its packaging, it is important that you follow the set up procedures described in this chapter before you commence using the unit. Follow the set up procedures in this sequence: 1

Remove the transit clamps and rubber band from around the stylus.

2

Connect to the power supply provided.

3

Insert the breathing tube and use a SafeTway or a BVF for each new subject.

4

Adjust the chart carrier.

5

Insert the Vitalogram chart.

6

Adjust the stylus.

7

Enter the temperature.

8

Configure the electronics module

Detailed instructions for performing these actions are described on the following pages. When the set up procedure is complete, you should check the accuracy in accordance with international recommendations for lung function testing equipment.

Removing the Transit Clamps Stylus locking screw Transit clamp Stylus head

Figure 2: The stylus head

1

Remove the rubber band from around the stylus head and unscrew the stylus locking screw.

2

Remove the stylus and lift out the transit clamp.

3

Replace the stylus and tighten the stylus locking screw.

4

Store the transit clamp so you can replace it if you need to transport the spirometer.

6

Figure 3: Front Transit Clamp

1.

Use a Pozi No. 2 screwdriver to remove both of the front handle retaining screws.

2.

Remove the handle.

3.

Carefully detach the front transit clamp and instruction leaflet from the spirometer.

4.

Place the handle back into position and refit the retaining screws securely with the screwdriver.

5.

Store the transit clamp so you can replace it if you need to transport the spirometer in future.

Connecting to a Power Source 1

Connect the power jack on the power supply cable into the rear panel of the Vitalograph Gold Standard Plus.

2

Plug the mains lead into the free end of the power supply and connect it to a suitable mains supply outlet.

3

Only use the power supply provided with the Gold Standard Plus.

Inserting the Breathing Tube and Mouthpiece or Filter Breathing Tube Filter/mouthpiece

Figure 4: Inserting the breathing tube and BVF mouthpiece

1

Insert the male end of the breathing tube provided into the front of the Vitalograph Gold Standard Plus.

2

Insert a SafeTway or BVF disposable mouthpiece into the plastic adaptor at the other end of the tubing. 7

Note: Vitalograph recommends the use of a BVF mouthpiece to provide maximum protection against the possibility of bellows contamination and subject cross infection during testing.

Adjusting the Chart Carrier It is important for the accuracy of test results that the chart carrier should move as soon as the subject starts to blow. If the thumbscrew controlling the chart carrier is set too low, the chart carrier will move without the subject blowing. If it is set too high, there may be a time delay before the chart carrier starts to move. The start of movement sensitivity can be adjusted by turning the chart travel thumbscrew under the back of the Vitalograph Gold Standard Plus.

Figure 5: The thumbscrew at the back of the Gold Standard

1 2

Press the Power switch to . If the chart carrier is not in the start position, i.e. as far to the left as it can go, press the Record switch to ←.

3 4

Inflate the bellows fully (either by blowing into it or with the aid of a Precision 1-L syringe) and then allow it to deflate naturally by disconnecting the breathing tube. Press the Record switch to →.

5

Lift the Vitalograph Gold Standard Plus slightly and turn the thumbscrew in the direction marked CONTINUOUS until the chart carrier starts to move.

6

Turn the thumbscrew in the opposite direction until the chart carrier stops. Continue turning the thumbscrew by one turn. This completes the chart carrier adjustment.

Should the chart carrier subsequently start before the stylus begins to move, it will be necessary to turn the thumbscrew a little further towards AUTO-START.

Inserting the Vitalogram Chart

Figure 6: How to insert the chart

1 8

Insert the Vitalogram chart with the zero line at the top (i.e. upside down).

2

Keeping the chart flat and its sides under the carrier sides, feed the chart upwards on the carrier (if necessary, lift the stylus to allow the chart to pass underneath).

3

Push back the chart clip sufficiently to lift it from the carrier surface.

4

Slide the chart under the clip until the chart rests against the top edge of the carrier. The chart is now inserted correctly.

Adjusting the Stylus Stylus locking screw

Lock ring

Figure 7: The stylus head

1

If the chart carrier is not in the start position, i.e. as far to the left as it can go, press the Record switch to ←.

2

Place the stylus on the Stylus Start position marked on the chart. Release the stylus locking screw if you need to move the stylus forward or backward, in order to position it correctly on the chart.

3

If you need to adjust the stylus pressure (trace not clear), release the lock ring and either screw the stylus clockwise to increase pressure or screw it counter-clockwise to reduce pressure. Tighten the lock ring when complete.

Powering Up the Gold Standard Plus Turn on the Vitalograph Gold Standard Plus by pressing the power switch on the front to . A display like the following example appears on the LCD. Note: for correct operation ensure that the Vitalograph Gold Standard Plus is switched off for a minimum period of 5 seconds before switching on again. S t a n d a r d P l u s G o l d 2 1 / 0 6 / 2 0 0 1 1 2 : 0 5 A c c . C h e c k : 2 0 / 0 6 / 0 1 M e m o r y : 9 0 % u s e d The fields on this display have the following meanings. Acc. Check The date of the last accuracy check of the Vitalograph Gold Standard Plus. International standards recommend that you check accuracy daily. Memory: Indicates the percentage of memory already used. If the memory is nearly full, you should archive and then delete subject information and results. 9

Pressing ESC at any time during this screen will allow you to continue. Alternatively, after a few seconds the Main Menu display appears on the unit (if Smart mode is disabled). >

P A T I E N T T E S T P R I N T P O S T

D E L E T E S E T U P V I EW C A L I B

Configuring the Electronics Module There are a number of settings that must be made using the keypad before you can use electronic features of the the Vitalograph Gold Standard Plus for the first time. You can change these settings at any time to suit your requirements. This is achieved by selecting Setup in the main menu. The following screen is displayed. S e l e c t o p t i o n > S A V E C O N F I G I N D I C E S S M A R T P R I N T E R A B O U T

Setting Up Save This is used to define the criteria for saving tests. If ATS or ERS Best are selected then the best test in a session is saved. If All is selected then every test in a session is saved. Saving of results is then performed automatically after a testing sequence. Select Save in the Setup menu. S e t u p S a v e A T S B E S T E R S B E S T A L L

<

ATS Criteria: highest FVC, highest FEV1. All other parameters are calculated from the curve with the highest FVC+FEV1 sum. ERS Criteria: highest FVC, highest FEV1. All other parameters are calculated from the curve with the highest FVC.

Setting Up Indices This is used to define the indices for which results will be displayed or printed. Select Indices in the Setup menu. I n d i c e s S e l e c t V C * F V C * F E V . 5

↓ <

The following list supplies definitions of the indices. Indices FVC Test FVC FEV .5 FEV .5/FVC% FEV .75 FEV .75/FVC% FEV 1 10

Definition Forced vital capacity (litres) Forced expiratory volume after 0.5 seconds (litres) Percentage FEV 0.5 of FVC (%) Forced expiratory volume after 0.75 seconds (litres) Percentage FEV 0.75 of FVC (%) Forced expiratory volume after 1 second (litres)

FEV 1/VC% FEV 1% FEV3 FEV 3/FVC% FEF 25-75% FEF 25-75/FVC% FEF 75-85% FEF .2-1.2 FEF 25% FEF 50% FEF 75% FMFT FET MVV Ind FIVC FIVC/FVC% FIF 25% FIF 50% FIF 75% FIF 50/FEF 50% VC Test VC

Percentage FEV 1 of VC (%) Percentage FEV 1 of FVC (%) Forced expiratory volume after 3 seconds (litres) Percentage FEV 3 of FVC (%) Maximal mid expiratory flow: the mean FEF in the time interval between 25% and 75% of the FVC (litres/sec) Percentage FEF 25-75 of FVC (%) Forced late expiratory flow: the mean FEF in the time interval between 75% and 85% of the FVC (litres/sec) Mean forced expiratory flow in the time interval between 0.2 and 1.2 seconds of the test time (litres/sec) Forced expiratory flow at 25% of the FVC (litres/sec) Forced expiratory flow at 50% of the FVC (litres/sec) Forced expiratory flow at 75% of the FVC (litres/sec) Forced mid-expiratory flow time (sec) Forced expiratory time (secs) Maximum voluntary ventilation indirectly calculated from the FEV (litres/min) Forced inspiratory vital capacity (litres) Percentage FIVC of FVC (%) Forced inspiratory flow at 25% of the FVC (litres/sec) Forced inspiratory flow at 50% of the FVC (litres/sec) Forced inspiratory flow at 75% of the FVC (litres/sec) Percentage FIF 50% of FEF 50% (%) Vital capacity (litres)

Selecting a Printer This is used to define the type of printer to be used for printing test results. Select Printer in the Setup menu. P r i n t er S e l e c t E P S O N F X S E R I E S H EW L E T T P A C K A R D C A N O N B J S E R I E S

↓ <

Defining Configuration This is used to define various features of the Vitalograph Gold Standard Plus such as the setting of the date and time. Select Config in the Setup menu. S e t C o n f i g u r at i o n > D A T E * I N T ER P T I M E * S O U ND P R E D I C T Setting the Date This is used to set up the current date and date format. Select Date in the Configuration menu. S e t t h e D a t e Y e a r 2 0 0 1 M on t h 1 0 D a y 1 8 Setting the Time This is used to set up the current time. Select Time in the Configuration menu. 11

t h e S e t H o u r M i n u t e S e c o n d

T i m e 1 0 < 4 4 0 0

Setting Predicted Values This is used to enable or disable the availability of predicted values with test results and if enabled, a correction factor can be applied to these predicted values. Select Predict in the Configuration menu. S e t P r e d i c t e d V a l u e s > * E N T E R D E M O G R A P H I C S R A C E C O R R E C T I O N If Enter Demographics is disabled, then subject demographics is not required to be entered before testing. S e C o r F a P r e s

t ‘ O t r e c t i c t o r s t ↵

h e r ‘ R a c e o n F a c t o r : 1 0 0 % < o C o n t i n u e

If you wish to offset the predicted values for the ‘Other’ race option, select Race Correction, use the
or  button to set Factor. An offset of between 50 % and 150 % can be set. Setting Interpretation This is used to enable or disable interpretation of results on the printout. Select Interp in the Configuration menu. Setting Sound This is used to turn off or turn on a tone which sounds with key presses and also acts as feedback while a test is being performed. Select Sound in the Configuration menu.

Defining Smart The Smart feature is used to automate actions you perform routinely by leading you through a sequence of functions such as performing an FVC test, running a post test, printing test results, and so on. In Smart, when you turn on the Vitalograph Gold Standard Plus, you are led through a sequence of displays that depend on the selected functions. (Be careful not to press the ESC button unless you wish to exit from Smart.) In order to set up Smart, select Config in the Setup menu. S e t

S m a r t F e at u r e s > O n T E S T S P O S T * P R I N T

Smart can be enabled or disabled here by simply pressing the ↵ button. Selecting Tests shows what test types can be performed. An asterisk is displayed to show it has been selected. At least one test must be selected.

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S m a r t S e t > V C * F V C

T e s t s

Select whether printing and post testing should occur as part of Smart mode. An asterisk is displayed to show it has been selected.

About the Software This is used to obtain information about the software. This information should be used if any queries are made to Vitalograph or a service agent.

CHECKING ACCURACY OF THE VITALOGRAPH GOLD STANDARD PLUS The Vitalograph Gold Standard Plus should be accuracy checked at room temperature prior to performing tests. International standards on spirometry recommend that you check accuracy regularly. If the temperature of your testing environment remains stable (within ±4°C) it should never be necessary to adjust the calibration after the initial set-up. You will need a 1-L Precision Syringe from Vitalograph (Cat. No. 20408) to enable you to check the accuracy of the Vitalograph Gold Standard Plus.

Checking Accuracy and Linearity 1

Ensure that the Vitalograph Gold Standard Plus and the syringe are at the same temperature (±2°C). You should have a thermometer in your spirometry test room and the devices be in that room at stable temperature for at least two hours. If this is not possible, filling the bellows from the syringe several times will equilibrate the temperature.

2

Attach the Vitalograph 1-Litre Precision Syringe to the breathing tube.

Figure 8: The 1 litre syringe connected to the Gold Standard Plus

3

Insert a chart in the chart carrier.

4

Set the stylus on the Stylus Start line at the base of the centre scale.

5

Switch the chart carrier switch to the stop position, i.e. the centre position.

6

Turn on the Vitalograph Gold Standard Plus and the main menu will be displayed;

7

Select Calib in the main menu.

8

Enter the ambient temperature.

13

S e t

A m b i e n t

T e mp

T e m p e r a t u r e : 2 0 º C < P r e s s t o C o n t i n u e ↵ Note: this screen is only displayed after power up. 9

Press the ↵ button. L a s t c a l i b r a t i on u p d a t e : 1 2 / 1 0 / 0 2 ↵ = C o n t i n u e

10

E S C = E x i t

Press the ↵ button. S e t s t y l u s s t y l u s s t a r t P r e s s

11

↵

t o

t o l i n e

C o n t i n u e

Press the ↵ button. I n j e c t 1 L i t r e i n t o b e l l o w s

12

Inject a steady flow of air into the Vitalograph Gold Standard Plus making sure that the syringe piston travels fully to the end stop

13

Mark the stylus position on the chart by gently tapping on the side of the stylus head. The LCD is updated to show the following information; C y c l e s 1 o f 7 R e f : 1 . 0 0 M e a s : 0 . 9 9 R e p e a t P u m p i n g E S C t o r e s t a r t

14

Repeat steps 12 to 13 to check the accuracy and linearity litre by litre, up to the seven litre position. Note: make sure you wait for at least half a second after filling the syringe to allow the volume to settle before pumping it into the Gold Standard Plus.

15

The display in step 13 is updated to show the new volume recorded plus the volume recorded for the previous stroke.

16

When you have completed the 7 strokes, the screen will prompt you to 'Please Wait' and the following screen will appear after a few seconds. P r o c e s s c o m p l e t e d D o y o u w i s h t o a u t o c o r r e c t ? = Y e s E S C = ↵

17

14

N o

Press the ↵ button if you wish to update the calibration (note: this should be done if any of the measured values differed from the reference values by more than 3%). If not, press the ESC button.

C a l ↵ 18

=

P r i n t i b r a t i o n R e p o r t ? Y e s

E S C

=

N o

Press the ↵ button if you wish to print a Calibration Report - ensure printer is attached. R e c h e c k ↵

=

a c c u r a c y ?

Y e s

E S C

=

N o

19

Press the ESC button to exit from the Accuracy Check procedure or press the ↵ button to start the process again.

20

If the stylus marks on the centre scale of the chart fall outside the shaded areas, you should adjust the calibration of the bellows as described in the next section.

Note: the calibration of the electronics can be altered independently of the bellows calibration. The converse is NOT true. To ensure that your chart results agree with the electronic results, it is strongly recommended that the bellows is calibrated (as outlined in the following section) prior to changing the calibration of the electronics.

Adjusting Calibration 1

Remove the top cover of the Vitalograph Gold Standard Plus by loosening the three thumbscrews at the back of the unit. Tilt it forward slightly while lifting it up. Note: care should be taken not to place excessive strain on the two cables that are connected to the top cover.

2

Remove the cables from the cable tidy clips if necessary and set the top cover down beside the Gold Standard Plus.

3

Loosen the two clamping screws using the Allen Key located on the Cam Bracket and open the Velcro fasteners.

4

If the unit is over reading slide the bellows plate (by use of the adjustment handles) towards the rear of the unit. Alternatively, if the unit is under reading slide the bellows plate towards the front of the unit.

5

Tighten the clamping screws and close the velcro fasteners.

15

Allen Key

Velcro fastener

Clamping screw

Figure 9: The bellows assembly

6

Re-check the accuracy on the chart to ensure the bellows setting is correct. If not, repeat steps 3 to 5 until the required accuracy is achieved.

7

Replace the top cover ensuring that the two cables are re-inserted to the cable tidies and that they are not in the path of the bellows travel.

8

Recheck the accuracy of the electronics module and adjust if necessary.

ENTERING OR SELECTING SUBJECT INFORMATION Before you can start performing a test for a subject, you must either: • •

Enter information for a new subject as described in the ‘Entering a New Subject’ section. or recall information previously entered for a subject, as described in the ‘Selecting an Existing Subject’ section.

Entering a New Subject Follow these steps to enter information for a new Subject. 1

Check that the cursor is next to the Patient menu and press the ↵ button. P a t i e n t >

2

16

A U T O M A N U A L

I D : R E C A L L

You can now either assign an automatic identification code to the subject or enter an alphanumeric identification code. To assign the automatic identification code, press the ↵ button to select the Auto option.

P a t i e n t I D N e w 0 2 0 1 5 _ 2 1 1 2 9 5 P 3 S e x M < H e i g h t 1 4 0 A g e 2 5 R a c e C a u c Or, to enter an identification code, select the Manual option. E n t e r S e x A g e

P a t i e n t

M < 2 5

I D < H e i g h t 1 4 0 R a c e C a u c

3

Press the
or  button until you have displayed the first character of the code. Press the ↵ button to accept it. Repeat this process for each character in the code (up to 15 characters). After you press the ↵ button to accept the last character of the code, press the ↵ button again and the cursor moves to the Sex field. Note: If no ID is entered, demographics may be entered and tests can be performed but results will NOT be saved.

4

Press the
or  button to display ‘F’ if the subject is female and press the ↵ button. The cursor will move to the Age field.

5

Press the
or  button to display the correct age of the subject and press the ↵ button. The cursor will move to the Height field.

6

Press the
or  button to display the correct height of the subject and press the ↵ button. The cursor will move to the Race field.

7

Press the
or  button to select the required race option and press the ↵ button. The display will return to the main menu.

Selecting an Existing Subject Follow these steps to recall information for an existing subject. 1

Check that the cursor is next to the Patient menu and press the ↵ button. P a t i e n t >

A U T O M A N U A L

I D : R E C A L L

2

Press the
or  button to move the cursor to the Recall option.

3

Press the ↵ button. S e l e c t P a t i e n t 0 2 0 1 5 _ 2 1 1 2 9 5 P 3 1 2 3 4 J O H N S M I T H

I D

↓ <

4

Press the  button to move the cursor to the Subject ID you wish to select.

5

Press the ↵ button to make the selection. The display will return to the main menu.

17

PERFORMING TESTS Instructing the Subject It is important that you instruct the subject clearly in the procedure to follow to perform a test before each test begins. When you are testing a subject, it is essential that you are enthusiastic in order to encourage the subject to make the maximum effort, especially when carrying out a forced expiratory test. Testing may be done either in the sitting or standing position. Indication of position is necessary on the report. The Standing position may not be appropriate in some circumstances, such as in hospitals where many patients may not be able to tolerate the standing position, especially when making forced manoeuvres. The selection of the position for testing is, therefore, an individual one. If the standing position is used, an appropriately shaped chair should be placed behind the patient/subject so he/she can quickly and easily be eased into a sitting position if he/she becomes light-headed during the manoeuvre. Following the completion of a test you can: • • •

Perform a post test, to compare the results of the post test with results from the pre- test for the subject; View the results for all the indices selected in the Setup menu; Print the test results;

It is assumed you have entered or selected a subject.

Performing a VC Test 1

Insert a Vitalogram chart in the chart carrier.

2

If the chart carrier is not in the start position, i.e. as far to the left as it can go, press the Record switch to ←.

3

Set the stylus on the Stylus Start point.

4

Select Test from the main menu and press the ↵ button.

5

When entering test mode for the first time after power up the following screen will be displayed. S e t

A m b i e n t

T e m p .

T e m p e r a t u r e : 2 0 º C < P r e s s t o C o n t i n u e ↵ 6

Press the
or  button to change the ambient temperature and press the ↵ button to select it.

7

Press the
or  button to move the cursor to VC and press the ↵ button. You will be prompted to 'Set stylus to stylus start point'. If the stylus is already at the start point press the ↵ button to continue. P E R F O R M

8

18

V C

T E S T

Inform the subject that you are measuring how much air they can exhale after filling their lungs completely.

9

Read the following instructions to the subject so that testing is performed properly. a)

Hold the breathing tube in one hand away from your mouth.

b)

Breathe in and out normally

c)

Inhale as deeply as possible, filling your lungs completely.

d)

Insert the mouthpiece into your mouth and close your lips around it making sure no air can leak out.

e)

Breathe out gently into the mouthpiece as completely as you can (remember to keep encouraging the subject to blow throughout the manoeuvre).

10

Continue the test until the stylus ceases to rise.

11

Take the breathing tube from the subject and deflect it away from their face.

Note: if safetway mouthpieces are being used it will be necessary to remove the mouthpiece to empty the bellows prior to re-testing. Testing will be accompanied by an audible incentive if Sound is selected in the Config menu. The following display appears after a couple of seconds. # 1 c o m p l e t e T e s t R e a d y f o r n e x t b l o w
a n d f o r r e s u l t s ↓ o r E S C t o e n d t e s t s You can press the
or  button if you wish to view predicted and measured results. If the stylus does not return to the start point, you will be prompted to 'Set stylus to stylus start point'. The unit is ready to accept another test at any time. The display will be updated with the new results if another test is performed. When you have finished VC testing, press the ESC button to return to the Select Test Type display.

Performing an FVC Test 1

Insert a Vitalogram chart in the chart carrier.

2

If the chart carrier is not in the start position, i.e. as far to the left as it can go, press the Record switch to ←.

3

Set the stylus on the Stylus Start point.

4

Press the Record switch to →.

5

Check that the cursor is next to the Test menu on the LCD and press the ↵ button. S e l e c t > V C F V C

6

T e s t

T y pe

Select FVC. You will be prompted to 'Set stylus to stylus start point'. If the stylus is already at the start point press the ↵ button to continue.

19

P E R F O R M

7 8

F V C

T E S T

Inform the subject that you are measuring how much and how fast they can exhale after filling their lungs completely. Read the following instructions to the subject so that testing is performed properly. a)

Hold the breathing tube in one hand away from your mouth

b)

Breathe in and out normally.

c)

Inhale as deeply as possible, filling your lungs completely.

d)

Insert the mouthpiece into your mouth and close your lips around it making sure no air can leak out.

e)

Breathe out into the mouthpiece as hard and fast as you can and exhale until I tell you to stop.

9

Continue the test until the stylus ceases to rise (a test can be considered complete if a two second plateau is observed prior to the chart stopping).

10

Tell the subject to stop when you are satisfied that they have expired their total air volume.

11

Take the breathing tube from the subject and deflect it away from their face.

Note: if safetway mouthpieces are being used it will be necessary to remove the mouthpiece to empty the bellows prior to re-testing. Testing will be accompanied by an audible incentive if Sound is selected in the Config menu. # 1 c o m p l e t e T e s t R e a d y f o r n e x t b l o w
a n d f o r r e s u l t s ↓ o r E S C t o e n d t e s t s Press the
or  to move through the pre-configured indices, predicted and measured results. When a good test session is achieved to ATS or ERS criteria (whichever is selected) a ‘√’ is displayed and 5 audible beeps will be heard if Sound is selected in the Config menu. See ‘Test Acceptance’. If you are saving all your tests and you are not satisfied with the last test, press the DEL button to clear the results of the last test. If the stylus does not return to the start point, you will be prompted to 'Set stylus to stylus start point'. Return the chart carrier to the start position and press the Record switch to →. The unit is now ready to accept another test at any time. The display will be updated with the new results if another test is performed. When you have finished FVC testing, press the ESC button to return to the Select Test Type display. The subject's best test can be recorded on a Serial Spirometry Record sheet along with a plot of the FEV1 value. Pads of 50 can be ordered from Vitalograph (Cat. No. 63054).

Performing a Direct MVV Test Note: This test was developed to detect malingerers in workplace disability testing. Today it is considered outdated and is very rarely performed. The use of FMFT correlation and other methods is preferred. 20