Model 2120 User Manual Issue 3

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 (Irl.) Ltd., Gort Road Business Park, Ennis, Co. Clare, Ireland Phone: (065) 6864100 Fax: (065) 6829289 e-mail: [email protected] www.vitalograph.com

© Copyright Vitalograph 1998, 2004 Current Edition (Issue 3) Cat. No. 07022

Vitalograph is a registered trademark

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Table Of Contents INTRODUCING THE VITALOGRAPH 2120... 5 Description of the Vitalograph 2120 ... 5 Features of the Vitalograph 2120... 5 Principles of Operation... 5 Using the Vitalograph 2120 with Peripheral Devices ... 6 Physical Features of the Vitalograph 2120 Unit... 6 INSTALLING THE VITALOGRAPH 2120... 8 Connecting the Vitalograph 2120 to a Power Source ... 8 Turning On the Vitalograph 2120 ... 9 Setting Up the Vitalograph 2120 ... 9 CHECKING ACCURACY ... 17 Attaching the Syringe to the Vitalograph 2120... 17 Any Problems ? ... 20 ENTERING OR SELECTING SUBJECT INFORMATION... 21 Entering a New Subject... 21 Selecting an Existing Subject... 23 PERFORMING TESTS ... 24 Entering temperature ... 24 Performing a VC Test... 25 Performing an FVC Test ... 26 Quality Criteria... 27 PERFORMING POST TESTS ... 30 Performing Post Tests... 30 VIEWING TEST RESULTS ... 32 PRINTING TEST RESULTS... 35 Connecting to a Printer ... 35 Printing Results ... 37 DELETING SUBJECT INFORMATION AND / OR TEST RESULTS ... 39 USING SMART... 41 CLEANING THE VITALOGRAPH 2120 ... 44 General Recommendation ... 44 Routine Practice ... 44 3

Components of Disassembled Vitalograph 2120... 45 Disassembling the Vitalograph 2120 ... 45 Cleaning and Disinfecting the Vitalograph 2120 ... 46 Reassembling the Vitalograph 2120 ... 48 CONSUMABLES, ACCESSORIES AND SPARE PARTS... 49 Consumables/Accessories... 49 Spare Parts ... 49 APPENDIX A: TROUBLE-SHOOTING... 50 APPENDIX B: TECHNICAL SPECIFICATIONS ... 53 APPENDIX C: POPULATION NORMAL VALUE REFERENCES ... 54 APPENDIX D: LIST OF REFERENCES ... 55 APPENDIX E: REGULATORY NOTICES ... 56 Explanation of symbols ... 56 CE Notice ... 56 FDA Notice ... 56 APPENDIX F: SAMPLE ACCURACY CHECK HISTORY SHEET... 57 When to check accuracy? ... 57 Your Units Accuracy Check History ... 58 GUARANTEE ... 59

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INTRODUCING THE VITALOGRAPH 2120 Description of the Vitalograph 2120 The Vitalograph 2120 is a hand-held spirometer designed for lung function testing in a variety of environments, e.g. hospital wards, occupational health centres, private homes.

Features of the Vitalograph 2120 The Vitalograph 2120 features include: •

database of subject information

•

performs FVC and VC pre- and post tests

•

test results are time and date stamped

•

stores the results of at least 100 tests

•

audible feedback device available

•

printouts of test results available

•

Smart option can automate actions by bypassing the menus

•

On screen battery low indicator

•

auto switch off after 30 minutes of no-use when running off the battery.

Principles of Operation The Vitalograph 2120 measures air expired from a subject by using a large diameter flowhead containing a Fleisch-type pneumotach capable of giving linear results throughout the entire physiological range. During testing, the air flow through the pneumotach produces a very low pressure differential. Internally this pressure is applied to a pressure transducer which produces an electric signal. This signal is converted into digital form, various calculations are performed and the results displayed.

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Using the Vitalograph 2120 with Peripheral Devices 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, eg. EN60950 for data equipment, EN60601 for medical equipment. Non medical equipment must be kept outside the patient environment ie. any area in which intentional or unintentional contact between the patient and parts of the system, or some other persons touching parts of the system, can occur. (Contact your distributor if you have any queries.)

Physical Features of the Vitalograph 2120 Unit

Description of Buttons on Unit Button

Name

Description

↵

ENTER

In a data field: selects the value displayed and moves the cursor to the next field. In a menu: selects the item next to the cursor and moves the cursor to the next display.

UP ARROW DOWN ARROW

Displays the next highest or an alternative value Displays the next lowest or an alternative value

ESC

ESC

Exits to the previous display

DEL

DEL

Deletes an entry or clears the last test if saving all results

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Description of Items on Screen Displays Item

Name

Action

>

Cursor

Marks a menu you wish to select (Note a menu appears in all upper case letters on the display)

<

Cursor

Marks a value you wish to select

↓

DOWN ARROW

Indicates there are more items for selection on the next display

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INSTALLING THE VITALOGRAPH 2120 Connecting the Vitalograph 2120 to a Power Source The Vitalograph 2120 is ready for use when you unpack it. It is recommended you connect the power supply to the unit, as described below, to ensure it is fully charged. Note that it is not necessary to turn on the Vitalograph 2120 when charging. Whenever testing is finished, the power supply should be connected for recharging. If the Vitalograph 2120 is not used over a prolonged period ie. one month or longer, before use recharge the battery for 16 hours. If a battery low indication is given, the unit should be placed on charge immediately.

Vitalograph 2120 Power Supply Mains Cable

Printer Printer Cable

Serial Cable

1.

Connect the 2120 Serial Cable (2120060) to the 2120.

2.

Plug the Power Supply (21001204) into the 2120 Serial Cable.

3.

Connect the Mains Cable to the Power Supply.

4.

Plug the other end of the Mains Cable into your nearest supply outlet. 8

Turning On the Vitalograph 2120 Turn on the Vitalograph 2120 by sliding the switch at the side of the unit towards the flowhead. A display like the following sample appears on the unit. V i t a l og r aph 2120 21 / 06 / 1995 12 : 05 Ca l . Ch e c k : 2 0 / 0 6 / 9 5 Me mo r y : 9 0% used The fields on the display have the following meanings. Cal. Check: The date of the last calibration check of the Vitalograph 2120. 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. (See Chapters 9 & 10.) Pressing ESC at any time during this screen will by-pass it.

Setting Up the Vitalograph 2120 There are a number of settings that must be made before you can use the Vitalograph 2120 for the first time. You can change these settings at any time to suit your requirements. It is assumed that the Vitalograph 2120 is turned on and the following main menu is displayed. >

PAT I ENT TEST PR I NT POS T

DELETE SETUP V I EW CAL I B

1.

Press the

button to move the cursor to the Setup menu.

2.

Press the ↵ button.

or

Se l e c t o p t i o n > SAVE CON F I G I ND I CES SMAR T PR I NTER A BOU T 3.

Continue with the steps in the following sections to make settings. 9

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. All saving of results is done automatically. 1.

Check the cursor is next to the Save option and press the ↵ button. Sa v e Se t u p A TS BEST E RS BEST A L L or

<

2.

Press the require.

button to move the cursor to the type of save you

3.

Press the ↵ button to make the selection.

ATS Criteria: highest FVC, highest FEV1, PEF from highest FVC+FEV1 sum. All other parameters are calculated from the curve with the highest FVC+FEV1 sum. ERS Criteria: highest FVC, highest FEV1, highest PEF. 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. 1.

Press the ↵ button.

button to move the cursor to the Indices option and press the

Se l e c t I nd i c e s VC * F VC * FEV . 5

↓ <

2.

Press on the ↵ button if you wish to select VC.

3.

Press on the to move down through the list of indices, using the ↵ button to select the required indices.

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The following list supplies definitions of the indices.

Indices

Definition

FVC Test FVC

Forced vital capacity (litres)

FEV .5

Forced expiratory volume after 0.5 seconds (litres)

FEV .5/FVC%

Percentage FEV 0.5 of FVC (%)

FEV .75

Forced expiratory volume after 0.75 seconds (litres)

FEV .75/FVC%

Percentage FEV 0.75 of FVC (%)

FEV 1

Forced expiratory volume after 1 second (litres)

FEV 1/VC%

Percentage FEV 1 of VC (%)

FEV 1%

Percentage FEV 1 of FVC (%)

FEV1/PEF

Ratio of FEV1 versus PEF

FEV3

Forced expiratory volume after 3 seconds (litres)

FEV 3/FVC%

Percentage FEV 3 of FVC (%)

PEF

Peak expiratory flow (litres/min)

FEF 25-75%

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

FEF 25-75/FVC%

Percentage FEF 25-75 of FVC (%)

FEF 75-85%

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

FEF .2-1.2

Mean forced expiratory flow in the time interval between 0.2 and 1.2 seconds of the test time (litres/sec)

FEF 25%

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

FEF 50%

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

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FEF 75%

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

FMFT

Forced mid-expiratory flow time (sec)

FET

Forced expiratory time (secs)

MVV Ind

Maximum voluntary ventilation indirectly calculated from the FEV (litres/min)

FIVC

Forced inspiratory vital capacity (litres)

FIVC/FVC%

Percentage FIVC of FVC (%)

PIF

Peak inspiratory flow (litres/sec or litres/min)

FIF 25%

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

FIF 50%

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

FIF 75%

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

FIF 50/FEF 50%

Percentage FIF 50% of FEF 50% (%)

VC Test VC

Vital capacity (litres)

Selecting a Printer This is used to define the type of printer to be used for printing test results. 1.

Press the ↵ button.

button to move the cursor to the Printer option and press the

Se l e c t P r i n t er E P SON F X S ER I E S H EWL E T T P A C K A R D C ANON B J S ER I E S 2.

Press the

3.

Press the ↵ button to select the printer.

↓ <

button, if required, to move to the printer you wish to select.

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P r i n t v i a Ba s e S t a t i o n ↵ 4.

=

Ye s

ESC

=

No

If you are printing through the Vitalograph Base Station, press ↵, otherwise, press ESC (you don’t have the Base Station but are printing directly to the printer).

Defining Configuration This is used to define various features of the Vitalograph 2120 such as the setting of the date and time. 1.

Press the

or

button to move the cursor to the Config option.

2.

Press the ↵ button. S e t C o n f i g u r at i o n > DATE * I N T ER P T I ME * S O U ND PRED I CT

Date This is used to set up the current date and date format. 1.

Press the button.

or

button to move the cursor to Date and press the ↵

Se t t h e Da t e Y e a r 1 9 9 5 M on t h 1 2 D a y 1 8

2.

Press the

or

button to set each field and press the ↵ button.

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Time This is used to set up the current time. 1.

2.

Press the button.

or

button to move the cursor to Time and press the ↵

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

T i me 1 0 < 4 4 0 0

Press the

button to set each field and press the ↵ button.

or

Population Normal (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. Se t P r e d i c t e d Va l u e s > * E N T E R D E MOG R A P H I C S RACE CORREC T I ON

1.

Press the ↵ button to deselect Enter Demographics if there is an asterisk (*) adjacent to it. Alternatively, if there is no asterisk adjacent to it, you can press the ↵ button to select it. If disabled, then subject demographics is not required to be entered before testing.

2.

Press the

button if you wish to set Race Correction.

Se t ‘ O t h e r ‘ Ra c e Co r r e c t i o n F a c to r F a c to r : 1 0 0% < P r e s s ↵ t o Co n t i n u e 4.

If you wish to offset the predicted values for the ‘Other’ race option, use the or button to set Factor field. An offset of between 50 % and 150 % can be set.

Interpretation This is used to enable or disable computer interpretation of results on the printout. 1.

Press the

button if you wish to select Interp.

2.

Press the ↵ button to deselect Interp if there is an asterisk (*) adjacent to it. 14

Alternatively, if there is no asterisk adjacent to it, you can press the ↵ button to select it. 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. 1.

Press the

button to move the cursor to Sound.

2.

Press the ↵ button to deselect Sound if there is an asterisk (*) adjacent to it. Alternatively, if there is no asterisk adjacent to it, you can press the ↵ button to select it.

Defining Smart This is used to define the functions you wish Smart to perform automatically. Smart is enabled by factory default. 1.

Press the button.

or

button to move the cursor to Smart and press the ↵

Se t

Sma r t F e at u r e s < On TESTS POS T * PR I NT

2.

Press the ↵ button to select or deselect Smart mode.

3.

Press the button to move the cursor to Tests to select the tests to be performed in Smart mode. Se t Sma r t > VC * FVC

T e s t s

4.

Press the ↵ button to select a test. An asterisk is displayed to show it has been selected. At least one test must be selected. Press the ESC button when you have finished making selections.

5.

Press the printed.

button to move the cursor to Print if you wish test results to be

Press the ↵ button and an asterisk is displayed to show it has been 15

selected. 6.

Press the run.

button to move the cursor to Post if you wish post tests to be

Press the ↵ button and 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.

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CHECKING ACCURACY When you turn on the Vitalograph 2120, it displays the date that accuracy was last checked on the unit. In accordance with the international standards governing spirometry, it is recommended that calibration is checked daily. ATS recommendations require that the difference between the volume measured by the spirometer and the volume pumped into the spirometer from the syringe is within 3%.

Attaching the Syringe to the Vitalograph 2120 Attach the Vitalograph 2120 to the precision syringe as illustrated in the following diagram. It is recommended that the Vitalograph 1 Litre Syringe can be used. This has an accuracy of +/-0.5%.

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Checking Accuracy of the Unit It is assumed that the Vitalograph 2120 is turned on and the following main menu is displayed. >

PAT I ENT TEST PR I NT POS T

1.

Press the

2.

Press the ↵ button. Se t

or

DELETE SETUP V I EW CAL I B button to move the cursor to the Calib menu.

Amb i e n t

T e mp

T emp e r a t u r e : 2 0 º C< P r e s s ↵ t o Co n t i n u e 3.

The ambient temperature must be entered. Note that this will only have to be entered once while the unit is switched on. If a temperature of over 40 is entered, then it will be accepted as Fahrenheit. Se t

S y r i n g e

Vo l ume : P r e s s ↵ t o

v o l u me 3 < Co n t i n u e

Note: If you are using a 1-L Syringe the Volume should be ‘1’. 4.

Using the or buttons, set the volume of the precision syringe that is being used. It is very important to set this up correctly, otherwise, the accuracy check will not function properly. I n j e c t S y r i n g e i n t o i n s t r u m e n t n o w . Wa i t f o r a u d I o f e e d b a c k t o r e p e a t .

5.

Ensure the syringe piston is fully withdrawn. At this point, connect the unit to the syringe and leave it in a stable position - do not move the unit during this procedure.

6.

With an even stroke, pump the contents of the syringe into the unit. The stroke must be at least one second in duration. 18

7.

Wait for a double beep, withdraw the syringe piston fully and repeat step 6 until five beeps occur. It is very important to wait for the double beep before withdrawing the piston each time. Vo l . d i f f e r e n c e w i t h p r e v i o u s c a l . : + 1. 5 % Ac c u r a c y c h e c k o v e r P r e s s ↵ t o Co n t i n u e

8.

The accuracy check is now complete. Press ↵ to continue. Ca l i b r a t i o n OK Do y o u r e q u i r e a p r i n t o u t ? E S C = No ↵ = Ye s or, C a l i b r a t i o n u p da t e r e c o mm e n d e d . D o y o u w i s h t o c o n t i n u e ? E S C = No ↵ = Ye s The calibration is OK when the volume difference with the previously stored calibration value is less than 3%. There is no need to update calibration here. (if, for some reason, an update is still required then press the DEL button at this stage) If the volume difference with the previously stored calibration value is greater than 3%, then an update is recommended.

9.

An accuracy check report can be printed when prompted to do so. Ensure your printer is set up correctly (refer to Chapter 9), and press ↵, otherwise press ESC.

Note: if you check accuracy during a test session and attempt to update the calibration, you will be informed that the current test session will be completed. If you press ↵, the calibration will be updated and the best test to date will be saved to the database. If you press ESC, the calibration will not be updated and testing can resume.

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Any Problems ? With reference to step 7 in the previous section, the user will be prompted (by means of a double beep) for another stroke of the syringe when the volume difference of the present stroke is not within 3% of the previous stroke. If the maximum of five strokes is executed, then the five beeps will occur, signifying the end of the accuracy check. The following screen will be displayed, F a u l t y t e c h n i q u e o r e q u i pme n t . Re f e r t o u s e r ma n u a l P r e s s ↵ t o Co n t i n u e If this occurs, refer to Appendix A - Trouble-shooting.

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