Model 2120 User Instructions

DESCRIPTION OF THE VITALOGRAPH 2120 The Vitalograph 2120 is designed for lung function testing not only in the doctor’s office or laboratory, but also for testing subjects on location, e.g. in hospital wards, factory floors, office buildings and private homes. All test data is automatically stored for later retrieval.

MAIN COMPONENTS OF THE VITALOGRAPH 2120 A B C D E F G H I

4. 5.

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Display Escape button Delete button Enter button Up button Down button On/Off switch Cradle portion Docking area

FEATURES OF THE VITALOGRAPH 2120 The Vitalograph 2120’s features include: • rechargeable battery sufficient for a full day’s testing • performs FVC and VC pre- and post-bronchodilator tests • a communications cradle which also charges the battery • database of subject information • test results are time and date stamped • stores over 100 tests • audio feedback assists test quality • retrieve data via printer or PC • smart option can automate actions by bypassing the menus • on screen battery low indicator • perform real-time testing with Spirotrac PC based spirometry system connecting through the cradle. • uploading subjects from Spirotrac to 2120 through the cradle • download test data from 2120 to Spirotrac through the cradle

CONNECTING THE VITALOGRAPH 2120 TO A POWER SOURCE The Vitalograph 2120 is ready for use after charging it for at least 16 hours. Dock the unit in it’s cradle, as described below, It is not necessary to turn on the Vitalograph 2120 when charging. The cradle must, however, be connected to a power source. Whenever testing is finished, the unit should be docked for recharging. If the Vitalograph 2120 is not used over a prolonged period ie. one month or longer, or if a battery low indication is given, the unit should be placed on the cradle to fully charge.

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Do not leave the hand-held portion in the cradle when there is no power to the cradle – this may drain the battery.

Power Output Serial Port

1. 2. 3.

4

Plug the power supply (21001204) into the power input socket at the back of the cradle as shown above. Plug the IEC connector end of the power cord into the PowerSAFE. Plug the other end of the power cord into your nearest supply outlet and switch the outlet on.

The cradle will now be capable of supplying low voltage power to the battery (green LED light). Simply dock the hand-held portion in the cradle (Orange LED when charging). 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 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. 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, switching off the offending device is the normal solution, as is required in aircraft and medical facilities. (Contact your distributor if you have any queries.)

TURNING ON THE VITALOGRAPH 2120 FOR THE FIRST TIME Turn on the Vitalograph 2120 by sliding the switch at the side of the unit towards the flowhead. The date that the device was last checked and the memory status are briefly displayed. Pressing ESC at any time during this screen will by-pass it. V i t a l o g r a p h 2 1 2 0 2 1 / 0 6 / 2 0 0 1 1 2 : 0 5 C a l . C h e c k : 2 0 / 0 6 / 0 1 M e m o r y : 9 0 % u s e d After a few seconds the main menu is displayed as illustrated below. >

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

SETTING UP THE VITALOGRAPH 2120 There are a number of settings that should be checked before you use the Vitalograph 2120 for the first time. In particular check Printer and Time/Date (In Config). 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. All saving of results is done automatically. Select Save in the Setup menu. S a v e S e t u p A T S B E S T E R S B E S T A L L

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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 indices which will be printed. (When archiving to PC all data are downloaded, regardless of print indices) Select Indices in the Setup menu. S e l e c t I n d i c e s V C * F V C * F E V . 5

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Use Up/Down Buttons to move cursor and Enter to select. * = ON The following list supplies definitions of the indices.

Indices FVC Test

Definition

FVC FEV .5

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

FEV .5/ FVC% FEV .75 FEV .75/ FVC% FEV 1 FEV 1/VC% FEV 1% FEV1/PEF FEV3 FEV3/FVC% PEF 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% PIF FIF 25% FIF 50% FIF 75% FIF 50/ FEF 50% VC Test VC

Forced expiratory volume after 0.75 seconds (litres) Percentage FEV 0.75 of FVC (%) Forced expiratory volume after 1 second (litres) Percentage FEV 1 of VC (%) Percentage FEV 1 of FVC (%) Ratio of FEV1 versus PEF Forced expiratory volume after 3 seconds (litres) Percentage FEV 3 of FVC (%) Peak expiratory flow (litres/min) 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 (%) Peak inspiratory flow (litres/sec or litres/min) 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 the PRINTER Driver This is used to define the type of printer to be used for printing test results. Select Printer in the Setup menu. S e l e c t P r i n t e r 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

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Note: you will be prompted whether you wish to print via the Base Station or not. Select No (ESC) here – this will ensure correct printing through the cradle. Do not select the Base Station as a printer at any time whilst using the cradle.

Defining CONFIGuration This is used to define various features of the Vitalograph 2120 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 Y e a r M on t h D a y

D a t e 2 0 0 1 1 0 1 8

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Setting the TIME This is used to set up the current time. Select Time in the Configuration menu. S e t t h e 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

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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 MO 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 patient demographics is not required to be entered before testing. S e t ‘ O t C o r r e c t i F a c t o r P r e s 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 Predict in the Configuration menu.

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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 2120, 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.)

Select the syringe volume type using the or buttons. It is very important to set this up correctly, otherwise, the accuracy check will not function properly. Note: If you are using a 3-L Syringe the Volume should be ‘3’. 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 . W a 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 .

Attaching the Syringe to the Vitalograph 2120 Place the syringe on a firm surface. Attach the Vitalograph 2120 to the precision syringe as illustrated in the following diagram i.e. with the on/off switch towards the table. It is recommended that the 1-L Syringe from Vitalograph be used. This has an accuracy of better than +/-0.5%.

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 Test shows what test types can be performed. An asterisk is displayed to show it has been selected. At least one test must be selected. S e t S m a r 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 Firmware This shows the version number and issue number of the firmware which drives the device. This information should be provided if any queries are made to Vitalograph or a service agent. Select Config in the Setup menu.

CHECKING ACCURACY When you turn on the Vitalograph 2120, it displays the date that a precision syringe was last used to check the accuracy of the device. International spirometry standards recommend that accuracy is checked at least daily. The difference between the volume measured by the spirometer in CALIB mode and the volume pumped from the syringe must be within 3%. If the flowhead has recently been used for testing, the temperature must be lowered to ambient by pumping room air through it several times prior to selecting CALIB. Select Calib in the main menu. S e t

A m b i e n t

T e mp

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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 ↵ 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. S e t

s y r i n g e

V o l u m e : P r e s s t o ↵

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v o l u m e 1 < C o n t i n u e

Ensure the syringe piston is fully withdrawn. Ensure a stable position - do not move the unit during this procedure. With an even stroke, empty the contents of the syringe into the spirometer device under test. The stroke must be at least one second in duration. Wait for a double beep, which informs the operator that the device is ready for another pump (without having to view the display). Withdraw the syringe piston fully and repeat this procedure until five beeps occur. It is very important to wait for the double beep before withdrawing the piston each time. Five beeps indicates that the accuracy check is now complete. Detach the syringe. V o 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 % A c c u r a c y c h e c k o v e r P r e s s t o C o n t i n u e ↵ Press ↵ to continue. You will be prompted for an accuracy check report. There is no need to update calibration. (if, for some reason, an update is required then press the DEL button at this stage). C a l i b r a t i o n O K D o y o u r e q u i r e a p r i n t o u t ? = Y e s E S C = N o ↵ If the device’s accuracy is outside the recommended tolerance, then a calibration update will be recommended.

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Calibration outside tolerance is highly unusual. Check for faults in flowhead or procedure. Re-test before adjusting calibration.

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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 ? = Y e s E S C = No ↵

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

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 ended. 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.

Press the button to move the cursor to the Patient ID you wish to select and press the ↵ button to make the selection.

ENTERING OR SELECTING SUBJECT INFORMATION In order to save results to the database, an ID must be assigned to a subject prior to testing. You can: • or •

enter information for a new subject recall information previously entered for a subject

Entering a New Subject Select Patient in the main menu. 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

For a quick, automatically assigned ID, select AUTO (this is based on the serial number of the Vitalograph 2120 device and today’s date). N e w P a t i e n t I D 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, For a specific ID, select MANUAL (e.g. if the subject’s name is required as the ID). E n t e r P a t i e n t I D _ < 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 Using the or buttons, select the first character of the ID. If you keep the button depressed, you will be able to speed scroll through the character range. Press ↵ to select the character. Follow this procedure to select further characters in the ID, if required. At any stage, if a mistake is made, use the DEL button to correct. 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 no results will be saved. Press the or button to display ‘F’ if the subject is female, and press the ↵ button. Press the or button to display the correct age of the subject, and press the ↵ button. Press the or button to display the correct height of the subject, and press the ↵ button. Press the or button to select the required race option, and press the ↵ button.

Selecting an Existing Subject If a subject’s details are already stored in the Vitalograph 2120 database, select Recall in the Patient menu.

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PERFORMING TESTS The Vitalograph 2120 can perform two types of tests: (Slow) VC and (forced) FVC. Select Test in the main menu. (You must first select a patient or create a new one.)

Entering Temperature Before proceeding, the ambient temperature must be entered. Note that this will only have to be entered only once while the unit remains switched on. If a temperature of over 40 is entered, then it will be accepted as Fahrenheit. 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 ↵

Hygiene It is vital for the user to set guidelines for protective hygiene measures whilst using the Vitalograph 2120. There are three main potential sources of cross contamination, skin contact; aerosolised particles and saliva/body fluids. By far the most important is the last item - a minimum requirement is to use a new disposable mouthpiece for each subject tested. We recommend using the SafeTway mouthpiece for expiratory tests or the Bacterial/Viral Filter for testing involving inspiratory and expiratory manoeuvres. We also recommend that a delay of at least 5 minutes be allowed between subjects. This allows aerosolised organisms to be removed by gravitational sedimentation between tests (Am J Respir Crit Care Med Vol 159. pp 610-612, 1999).

Performing a VC Test Fit a disposable noseclip to the subject. Ensure that a new BVF (Bacterial Viral Filter) or SafeTway mouthpiece is inserted into the Vitalograph 2120 for each new subject. Select VC in the Test menu. Pass the spirometer to the subject, keeping it in a vertical position and away from their mouth (ensure that the device is not jerked while handing it to the subject). P E R F O R M

V C

T E S T

Use the following instructions to the subject to ensure that testing is performed properly, first demonstrating yourself with a mouthpiece (adding “like this”): • “I am first going to test how big your lungs are” • “Inhale as deeply as possible, and hold your breath” • “Insert the mouthpiece into your mouth, biting it lightly” • “Close your lips round the mouthpiece”. • Now, exhale normally for as long as possible. Testing will be accompanied by audible feedback if Sound is selected in the Setup menu. When the beeps become slow, urge the subject to full expiration with: • “Squeeze, push, empty your lungs completely…” An animated performance by the operator is essential to get the subject to perform a good test. If Sound is enabled two beeps will occur soon after the subject stops blowing. After the two beeps the spirometer is ready to accept another blow. After resting time, re-test the subject until you are satisfied that a good VC has been performed. When you have finished VC testing, take back the spirometer and congratulate: • “Well done”. 7

Press the ESC button. Note: Before pressing ESC you can press the arrow buttons to view test quality messages, predicted and measured results, but this should not be necessary. T e s t # 1 c o m p l e t e 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

Performing an FVC Test Select FVC in the Test menu. Give the device to the subject.

T e s t # 1 c o m p l e t e 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 a quality summary of the test session to date and the pre-configured indices, predicted and measured results. F V C F E V 1 P E F

L A S T 5 . 3 5 5 . 1 2 5 2 4

B E S T 5 . 3 6 5 . 1 2 5 2 4

PERFORMING POST-BRONCHODILATOR TESTS P E R F O R M F V C T E S T E x p i r a t o r y o n l y Give the following instructions to the subject to ensure that testing is performed properly, first demonstrating youself with a mouthpiece (adding “like this”): • “I am now going to test how fast you can blow out” • “Inhale as deeply as possible, and hold your breath” • “Insert the mouthpiece into your mouth, biting it lightly” • “Close your lips round the mouthpiece”. • Exhale as fast as possible, keep going, go on…” • Keep the subject exhaling for at least 6 seconds. An animated performance by the operator is essential to get the subject to perform a good test. Testing will be accompanied by audible feedback if Sound is selected in the Setup menu. If inspiratory parameters are required, continue with: “Now, fully inhale as quickly as possible” The unit is ready to accept another test when two beeps occur (if Sound is enabled). After resting time, re-test the subject until you are satisfied that a good FVC has been performed or until the unit beeps five times, which indicates that the ATS criteria for test quality have been fulfilled or that eight tests have been completed in this session. Take back the spirometer and congratulate: • “Well done”. S u c c e s s f u l s e s s i o n T e s t i n g o v e r P r e s s f o r m e n u o r ↵ a n d f o r r e s u l t s ↓ Note: if, for some reason, it is required that testing continues, simply press ESC to proceed. The patient'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). After performing the test series, return the device back to the cradle. Normally no examination of the Vitalogaph 2120 display is required, but various information is displayed for the operator who is having difficulties: S l o w s t a r t o A b r u p t e n d o D u r a t i o n : 4 W A I T P L E A S E .

f t e s t f t e s t . 6 . .

Note: Quality messages like this will be shown on screen for a few seconds. relating to the test just performed.

Bronchodilation or provocation testing may be performed in Post mode. Post tests can be performed on a subject who has been previously tested. Select Post in the main menu. Post testing can be performed on the current subject or can be performed on a previously stored subject. S e l e c t P o s t T y p e > C U R R E N T R E C A L L P A T I E N T Testing can continue as described previously.

VIEWING TEST RESULTS The results for indices are displayed automatically when you perform a test. You can also view the current test results or previously stored results for all the indices selected in the Setup menu. Subject demographics can also be recalled for viewing. This achieved by selecting View in the main menu. S e l e c t V i e w O p t i o n > C U R R E N T T E S T R E C A L L T E S T P A T I E N T D A T A If selecting a test to view, then you will see a screen like this. S e 1 3 1 3 1 3

l : : :

e c t T e s t 1 2 1 2 / 1 2 / 9 5 1 2 1 2 / 1 2 / 9 5 2 0 1 2 / 1 2 / 9 5

Press the select.

V < F p F

button to move the cursor to the test you wish

Note: a test marked with ‘p’ signifies that it is a post test. Subject demographics can be recalled for viewing by selecting Patient Data and the appropriate subject . P a t i e n t D e m o g r ap h i c s 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

PRINTING TEST RESULTS The Vitalograph 2120 is capable of printing informative, well presented reports. Ensure that the correct printer is selected in the Setup menu as previously described. There are three choices available for printing test results: • • •

printing the results of the current test printing the results of all stored tests for all subjects printing the results of a particular test stored for a specified subject

Connecting to a Printer For printing, the Vitalograph 2120 Printer Cable (2120505) is required to interface between the cradle and the parallel port of the printer. Use the following procedure.

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1. 2. 3. 4. 5.

Ensure everything is powered off and unplugged before setting up. Connect Printer Cable (2120505) to the serial port of the cradle. Connect the other end of the Printer Cable to the printer. Switch the printer on. Plug the power supply into the cradle.

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

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Select the appropriate subject. S e l e c t D e l e t e O p t i o n > R e s u l t s o n l y P a t i e n t & R e s u l t s Selecting Results only will delete the results for this subject but not the subject demographics. Selecting Patient & results will delete this subject and the associated results.

USING THE VITALOGRAPH 2120 WITH SPIROTRAC

Printing Results Select Print in the main menu. Ensure that the printer is switched on and that the Vitalograph 2120 is placed in the cradle. S e l e c t P r i n t > C U R R E N T A L L R E C A L L

O p t i o n

Spirotrac is Vitalograph’s PC based spirometry system. For more information, contact your local sales agent. In order to use the Vitalograph 2120 with Spirotrac, the Spirotrac Connectivity Kit (74075) must be purchased. To connect the Vitalograph 2120 to Spirotrac, connect the cradle to the PC with the 9 way to 9 way serial cable. If realtime connection is required (e.g. for curve visualisation) connect the hand-held portion to the cradle with the coily cable as illustrated below.

If a test has just been completed, without switching the device off, select Current to print the results. It is recommended that test results are archived daily. This can be achieved by selecting the All option. A subject can also be recalled from the database for printing. Note: as soon as the Vitalograph 2120 returns to the main menu, it can be lifted from the cradle – but not beforehand.

DELETING SUBJECT INFORMATION AND / OR TEST RESULTS

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It is important to delete data once it is archived on paper or via a PC. Failure to do this good housekeeping will slow down operation of the device by filling the temporary memory bank.

There are four choices available for data deletion: • all tests and all subject information • all tests for all subjects but no subject information • all tests for a specified subject and his or her subject information • all tests for a specified subject but no patient information Select Delete in the main menu.

For further information on setting up Spirotrac, consult the Spirotrac user manual.

S e l e c t D e l e t e O p t i o n > A L L P A T I E N T S O N E P A T I E N T

Deleting All Subjects S e l e c t D e l e t e O p t i o n > R e s u l t s o n l y P a t i e n t & r e s u l t s Selecting Results only will delete the results for all the subjects in the database but not the subject demographics. Selecting Patient & results will delete everything from the database - results and subject demographics.

Deleting One Subject

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EXPLANATION OF SYMBOLS

CLEANING AND DISINFECTING THE VITALOGRAPH 2120

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Definitions of cleaning and disinfection are as defined in "Sterilization, Disinfection and Cleaning of Medical Equipment: Guidance on Decontamination from the Microbiology Committee to Department of Health Medical Devices Directorate, 1996" Recommendations for chemical disinfectants are derived from the PHLS publication "Chemical Disinfection In Hospitals" 1993. * May be autoclaved dry or wet; up to 134ºC; up to 20 mins; up to 50 cycles. Part Material Recommended Disinfectants Case A.B.S. Wiping with a 70% exterior Isopropyl Alcohol impregnated cloth Contact Tin plated provides a suitable form of pins & brass cleaning and low-level sockets disinfection. Flowhead T.P.X. Disinfect by immersion in cone* sodium dichloroisocyanurate Flow Acetal solution at 1000 ppm conditioning and concentration of free mesh Polyester chlorine for 15 minutes. (see recommended End cap* T.P.X. cleaning/disinfection Fleisch Anodized method for the element* Aluminium Vitalograph 2120) &

Class II VA

Power rating

V

Voltage DC

h

Attention (reference relevant section in manual)

Other Labels Serial connector Power input connector On (I) / Off (O) switch Power indicator Docking indicator

stainless steel O-Rings* Viton * Will also withstand autoclaving at 134°C for 3 minutes.

CONSUMABLES/ACCESSORIES Cat. No. 20242 20303 20408 36020 28350 42084 74075 2120505

Clean each separate part of the flowhead by washing in a mild detergent to remove particulate contamination. To clean the Fleisch element, swill vigorously in water with mild detergent. Do not attempt to “rub” or “scrub” at capillaries. If the flow conditioning meshes appear dirty or blocked they should be thrown away and replaced. Rinse with clean water. Disinfect by immersion in sodium dichloroisocyanurate solution at 1000 ppm concentration of free chlorine for 15 minutes. Prepare disinfectant solution as directed in the manufacturer’s guidelines. Rinse with hot water to aid drying. End Cap Flow Conditioning Mesh

2120 Unit Flow Conditioning Mesh Cone

Leave to dry completely before reassembling. Drying the Fleisch element assembly may require placing it in a warm place overnight. A drying cabinet is ideal, alternatively another heat source could be used. Wiping with a 70% Isopropyl Alcohol impregnated cloth provides a suitable form of cleaning and low-level disinfection for the case exterior, display, and keypads. Repeat at least weekly to prevent build-up of grime from normal handling and use. Always follow the safety guidelines given by the manufacturer of cleaning and disinfectant chemicals or equipment.

Description SafeTway Mouthpieces (200) Noseclips (10) 1-L Precision Syringe 3-L Precision Syringe BVF (50) Flow Conditioning Meshes (10) Spirotrac to Cradle Connectivity Kit 2120 Intelligent Printer Cable

SPARE PARTS

Fleisch Element

10

Type BF equipment

Cat. No. 31297SPR 31375SPR 31376SPR 62019SPR 62006SPR 66408SPR 20979 74076 76062 21001204 2120060

Description Power Cord - UK Power Cord - USA –Power Cord - European Flowhead Cone Flowhead End Cap Large Carrying Pouch Large Instrument Briefcase with Foams 2120 to Cradle Coily Cable 9 Way to 9 Way Serial Cable PowerSAFE 2120 Serial and power lead cable

TECHNICAL SPECIFICATIONS Flow detection principle Back pressure Volume measurement Maximum recorded flow rate Maximum recorded volume Measuring accuracy Operating temperature Safety standards Spirometric standards Power supply Battery Fuse Size (spirometer) Weight (spirometer) Size (cradle) Weight (cradle) Storage Temperature Storage Relative Humidity

Fleisch type pneumotachometer No4 size < 0.1kPa/L/s (ATS 1994 standard) Flow integration @ 100Hz ±14L/s >8 L Better than ±3% or ±0.05L volume whichever is greater and ±5% flow (inspiratory: ±5% vol., ±8% flow) 15-40ºC Conforms to EN60601-1, EN60601-1-2 ATS 1994 and ERS 1993 Input 98V - 264V AC 50/60 Hz Output 10V DC @ 3A 3.6V Rechargeable Nickel Cadmium (3 x AA size) Capacity = 0.6Ah 500mA 215x130x70mm 520g 300x250x130mm 1.35Kg 0-50ºC 10% - 95%

CE Notice

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Marking by the symbol indicates compliance of the <device> to the Medical Devices directive of the European Community. Such marking is indicative that the <device> meets or exceeds the following technical standards: • EN60601-1 - “General requirements for safety” • EN55011 - “Radiated and mains conducted emissions for industrial, scientific and medical (ISM) radiofrequency equipment” • IEC801-2 - “Electromagnetic compatibility for industrial-process measurement and control equipment Part 2: Electrostatic discharge requirements.” • IEC801-3 - “Electromagnetic compatibility for industrial-process measurement and control equipment Part 3: Radiated electromagnetic field requirements.”

GUARANTEE Subject to the conditions listed below, Vitalograph Ltd. and its associated companies, (hereinafter called the Company) guarantee to repair or at its opinion replace any component thereof, which, in the opinion of the Company is faulty or below standard as a result of inferior workmanship or materials. The conditions of this Guarantee are: 1. This Guarantee shall only apply to hardware defects which are notified to the Company or to its accredited distributor within 1 year of the date of purchase of the equipment, unless otherwise agreed in writing by the Company 2. Software (meaning computer software, or user installable modules) is guaranteed for 90 days from the date of purchase. 3. The Company warrants that the software when correctly used in conjunction with the hardware will perform in the manner described in the Company's literature and user manuals. The Company undertakes to rectify at no expense to the customer any software failure notified within the period stated above, provided that the failure can be recreated and the software has been installed and used in accordance with the user manual. Notwithstanding this clause, the software is not warranted to be free of errors. 4. This Guarantee does not cover any faults caused by accident, misuse, neglect, tampering with the equipment, use of consumable items or parts not approved by the Company, or any attempt at adjustment or repair other than by personnel accredited by the Company, nor does it cover reinstatement of any configuration changes caused by the installation of any software. 5. If a defect occurs, please contact the supplier from whom it was purchased for advice. The Company does not authorise any person to create for it any other obligation or liability in connection with Vitalograph equipment 6. This guarantee is not transferable and no person, firm or company has any authority to vary the terms or conditions of this Guarantee. 7. To the maximum extent permitted by law, the Company does not accept liability for any consequential damages arising out of the use of, or inability to use any Vitalograph equipment. 8. This Guarantee is offered as an additional benefit to the Consumer's statutory rights and does not affect these rights in any way.

FDA Notice Caution: Federal Law restricts this device to sale by, or on the order of a physician.

CUSTOMER SERVICE Service and repairs should be carried out only by the manufacturer, the approved importer or by Service Agents specifically approved by Vitalograph. For the names and addresses of approved Vitalograph Service Agents or to arrange spirometry workshops, please contact information on page 2.

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