Model 2120 User Manual Issue 1

Vitalograph Ltd., Maids Moreton, Buckingham, MK18 1SW, England Phone: (01280) 827110 Fax: (01280) 823302 e-mail: [email protected] Internet: www.vitalograph.co.uk Vitalograph GmbH, Jacobsenweg 12, 22525 Hamburg, Germany Phone: (040) 54 73 91-0 Fax: (040) 547 391 40 e-mail: [email protected] Internet: www.vitalograph.de Vitalograph Inc., 8347 Quivira Road, Lenexa, Kansas 66215, U.S.A. Phone: (913) 888-4221 Fax: (913) 888-4259 e-mail: [email protected] Internet: www.vitalograph.com Vitalograph (Irl.) Ltd., Ennis Industrial Estate, Gort Road, Ennis, Co. Clare, Ireland Phone: (065) 6864100 Fax: (065) 6829289 e-mail: [email protected] Internet: www.vitalograph.ie

© Copyright Vitalograph 2001 Current Edition (Issue 1) Cat. No. 07145

Vitalograph is a registered trademark

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TABLE OF CONTENTS Description of the Vitalograph 2120...4 Features of the Vitalograph 2120 ...4 Connecting the Vitalograph 2120 to a Power Source...5 Turning On the Vitalograph 2120...6 Setting Up the Vitalograph 2120 ...6 Setting Up Save ...6 Setting Up Indices ...7 Selecting a Printer ...8 Defining Configuration ...8 Setting the Date ...8 Setting the Time ...9 Setting Predicted Values ...9 Setting Interpretation ...9 Setting Sound...9 Defining Smart...10 About the Software ...10

Checking Accuracy ...10 Attaching the Syringe to the Vitalograph 2120 ...11

Entering Or Selecting Patient Information ...13 Entering a New Patient ...13 Selecting an Existing Patient ...14

Performing Tests...14 Entering temperature ...14 Performing a VC Test ...14 Performing an FVC Test ...15

Performing Post Tests ...16 Viewing Test Results ...17 Printing Test Results ...17 Connecting to a Printer...18 Printing Results ...18

Deleting Patient Information And / Or Test Results ...18 Deleting All Patients ...19 Deleting One Patient ...19

Using the Vitalograph 2120 With Spirotrac...20 Cleaning and Disinfecting the Vitalograph 2120...20 Explanation of symbols ...21 Other labels ...21

Consumables/Accessories...22 Spare Parts ...22

Technical Specifications ...22 CE Notice ...23 FDA Notice...23

Customer Service ...24 Guarantee ...25

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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 and private homes.

FEATURES OF THE VITALOGRAPH 2120 The Vitalograph 2120’s features include: • performs FVC and VC pre- and post tests • a cradle to store the device for battery charging • database of patient information • test results are time and date stamped • stores the results of at least 100 tests • audible feedback device available • printouts of test results available via the cradle • smart option can automate actions by bypassing the menus • on screen battery low indicator • Performing real time testing with Spirotrac PC based spirometry system through the cradle. • Uploading patient records from Spirotrac PC based spirometry system to 2120 through the cradle • Downloading patient records and tests from 2120 to Spirotrac PC based spirometry system through the cradle. • auto switch off after 30 minutes of no-use when running off the battery. Display Escape button Delete button Enter button Up button On/off switch

Down button

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CONNECTING THE VITALOGRAPH 2120 TO A POWER SOURCE The Vitalograph 2120 is ready for use when you unpack it. It is recommended you dock the unit in its cradle, as described below, to ensure it is fully charged. Note that 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, before use recharge the battery for 16 hours. If a battery low indication is given, the unit should be placed on the cradle immediately.

Power Input Serial Port

1. Plug the power supply (21001204) into the back of the cradle as shown above. 2. Connect the mains cable to the Power Supply. 3. Plug the other end of the Mains Cable into your nearest supply outlet. 4. The cradle will now be capable of supplying power to the Vitalograph 2120. Simply dock it in the cradle as illustrated below. Cradle

2120 docking area

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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.)

TURNING ON THE VITALOGRAPH 2120 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 Ca l . Ch e c k : 2 0 / 0 6 / 0 1 Memo r y : 9 0% u s e d After a few seconds the main menu is displayed as illustrated below. >

P A T I ENT TEST PR I NT POS T

DELETE SETUP V I EW CAL I B

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. This is achieved by selecting Setup in the main menu. The following screen is displayed. 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 ABOUT

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.

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Sa v e Se t u p A TS BEST E RS BEST A L L

<

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. Select Indices in the Setup menu. Se l e c t I n d i c e s VC * FVC * FEV . 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 FEV 1/VC% FEV 1% FEV1/PEF FEV3 FEV 3/FVC% PEF FEF 25-75% FEF 25-75/FVC% FEF 75-85% FEF .2-1.2 FEF 25% FEF 50% FEF 75%

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) 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) 7

FMFT FET MVV Ind FIVC FIVC/FVC% PIF FIF 25% FIF 50% FIF 75% FIF 50/FEF 50% VC Test VC

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 a Printer This is used to define the type of printer to be used for printing test results. Select Printer in the Setup menu. 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

↓ <

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 > DATE * I N T ER P T I ME * S O U ND PRED I CT Setting the Date This is used to set up the current date and date format. Select Date in the Configuration menu.

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Se t t h e Da 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. 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

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. Se t P r e d i c t e d Va l u e s > * E N T E R D EMOG R A P H I C S R A C E CORR EC T I ON If Enter Demographics is disabled, then patient demographics is not required to be entered before testing. Se t ‘ O t h e r ‘ Ra c e Co r r e c t i o n F a c t o r F a c t o r : 1 0 0% < P r e s s ↵ t o Co n t i n u e If you wish to offset the predicted values for the ‘Other’ race option, select Race Correction. Use the IorJ 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. 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.

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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.) In order to set up Smart, select Config in the Setup menu. Se t

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

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. Se t Sm a r t > VC * FVC

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. Select Config in the Setup menu.

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 accuracy 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%.

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Attaching the Syringe to the Vitalograph 2120 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 Vitalograph 1 Litre Syringe be used. This has an accuracy of +/-0.5%. If the flowhead has recently been used for testing then the temperature must be lowered to ambient by pumping room air through it prior to calibration using the syringe.

Select Calib in the main menu. Se t

Am b 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 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

V o l ume : P r e s s ↵ t o

v o l ume 1 < Co n t i n u e 11

Select the syringe volume type using the Ior J 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 ume 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 . 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. With an even stroke, pump the contents of the syringe into the unit. The stroke must be at least one second in duration. Wait for a double beep, withdraw the syringe piston fully and repeat stroking 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% A c 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 The accuracy check is now complete. Press ↵ to continue. You will be prompted for an accuracy check report. 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). C a 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 ? ESC = No ↵ = Ye s If the device’s accuracy is outside the recommended limits, then a calibration update will be recommended. 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 ? = Ye s E S C = No ↵ 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. 12

ENTERING OR SELECTING PATIENT INFORMATION In order to save results to the database, an ID must be assigned to a patient prior to testing. You can: • enter information for a new patient or • recall information previously entered for a patient

Entering a New Patient Select Patient in the main menu. Pa t i e n t >

I D :

AUTO MANUA L

RECAL 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). New Pa t i e n t I D 0 2 0 1 5 _ 2 1 1 2 9 5P3 S e x M< He i g h t 1 4 0 A g e 2 5 Ra c e Ca u c or, For a specific ID, select MANUAL (e.g. if the patient’s name is required as the ID). En t e r Se x A g e

M< 2 5

Pa t i e n t

I D < He i g h t 1 4 0 Ra c e Ca u c

Using the IorJ 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 IorJ button to display ‘F’ if the patient is female, and press the ↵ button. 13

Press the IorJ button to display the correct age of the patient, and press the ↵ button. Press the IorJ button to display the correct height of the patient, and press the ↵ button. Press the IorJ button to select the required race option, and press the ↵ button.

Selecting an Existing Patient If a patient has previously performed a test and that patient’s details are already stored in the database, select Recall in the Patient menu. Se l e c t Pa t i e n t 0 2 0 1 5 _ 2 1 1 2 9 5P3 1 2 3 4 J OHNSM I T H

I D <

↓

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

PERFORMING TESTS You can use the Vitalograph 2120 to perform two types of tests: VC and 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 once while the unit is switched on. If a temperature of over 40 is entered, then it will be accepted as Fahrenheit. Se t

Amb i e n t

T emp .

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

Performing a VC Test Ensure that a new mouthpiece is inserted into the Vitalograph 2120 for a new patient. Select VC in the Test menu. P E R F ORM

VC

TEST

Read the following instructions to the patient so that testing is performed properly. 14

• •

Stand up. Take hold of the unit, keeping it a vertical position and away from your mouth (ensure that the device is not jerked while handing it to the subject). • Inhale as deeply as possible and insert the mouthpiece into your mouth, clamping it between your teeth. • Close your lips round the mouthpiece. • Exhale normally for as long as possible. Testing will be accompanied by audible feedback if Sound is selected in the Setup menu. T e s t # 1 c omp l e t e R e a d y f o r n e x t b l o w á a n d ↓ f o r r e s u l t s o r ESC t o e n d t e s t s You can press the IorJ button if you wish to view test quality messages, predicted and measured results. The unit is ready to accept another test at any time. If Sound is enabled two beeps will occur. The display is updated with the new results. When you have finished VC testing, press the ESC button. After performing a test, ensure that the unit is placed in the cradle.

Performing an FVC Test Ensure that a new mouthpiece is inserted into the Vitalograph 2120 for a new patient. Select FVC in the Test menu. P E R F ORM F V C T E S T E x p i r a t o r y o n l y Read the following instructions to the patient so that testing is performed properly. • Stand up. • Take hold of the unit, keeping it in a vertical position and away from your mouth (ensure that the device is not jerked while handing it to the subject). • Inhale as deeply as possible and insert the mouthpiece into your mouth, clamping it between your teeth. • Close your lips round the mouthpiece. • Exhale as quickly as possible and try to keep exhaling for at least 6 seconds. Testing will be accompanied by audible feedback if Sound is selected in the Setup menu. • If inspiratory parameters are required, continue with next step. • Inhale as quickly as possible until your lungs have filled up again. 15

S l ow s t a r t o f A b r u p t e n d o f D u r a t i o n 4 . 6 WA I T P L E A S E

t e s t t e s t

Quality messages like this will be shown on screen for a few seconds. This relates to the manoeuvre just performed. T e s t # 1 c omp l e t e R e a d y f o r n e x t b l o w á a n d ↓ f o r r e s u l t s o r ESC t o e n d t e s t s The unit is ready to accept another test when two beeps occur (if Sound is enabled). Press the IorJ to move through a quality summary of the test session to date and the pre-configured indices, predicted and measured results. F VC F EV1 P EF

LAST 5 . 3 5 5 . 1 2 5 2 4

BEST 5 . 3 6 5 . 1 2 5 2 4

Repeat the above procedure until the unit beeps five times. Su 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 me n u o r á a n d ↓ f o r r e s u l t s Note: if, for some reason, it is required that testing continue, simply press ESC to proceed. After performing a test, ensure that the unit is placed in the cradle.

PERFORMING POST TESTS Bronchodilation or provocation testing may be performed in Post mode. Post tests can be performed on a patient who has been previously tested. Select Post in the main menu. Post testing can be performed on the current patient or can be performed on a previously stored patient. 16

Se l e c t Po s t T y p e > CURRENT RECA L L PAT I ENT 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. Patient demographics can also be recalled for viewing. This achieved by selecting View in the main menu. Se l e c t V i ew Op t i o n > CURRENT T ES T RECA L L TEST PAT I ENT DATA If selecting a test to view, then you will be faced with a screen like this. Se l e c t T e s t 1 3 : 1 2 1 2 / 1 2 / 9 5 1 3 : 1 2 1 2 / 1 2 / 9 5 1 3 : 2 0 1 2 / 1 2 / 9 5

V < F p F

Press the Jbutton to move the cursor to the test you wish select. Note: a test marked with ‘p’ signifies that it is a post test. Patient demographics can be recalled for viewing by selecting Patient Data and the appropriate patient. P a t i e n t D emo g r ap h i c s 0 2 0 1 5 _ 2 1 1 2 9 5P3 S e x M< He i g h t 1 4 0 A g e 2 5 Ra c e Ca 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 patients printing the results of a particular test stored for a specified patient 17

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.

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.

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. Se l e c t P r i n t > CURRENT AL L RECA L L

Op t i o n

If a test has just been completed, 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 patient 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 PATIENT INFORMATION AND / OR TEST RESULTS There are four choices available for data deletion: • • • •

all tests and all patient information all tests for all patients but no patient information all tests for a specified patient and his or her patient information all tests for a specified patient but no patient information

Select Delete in the main menu.

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Se l e c t De l e t e Op t i o n > A L L PAT I ENTS ONE PA T I ENT

Deleting All Patients Se l e c t De l e t e Op t i o n > Re s u l t s o n l y Pa t i e n t & Re s u l t s Selecting Results only will delete the results for all the patients in the database but not the patient demographics. Selecting Patient & results will delete everything from the database - results and patient demographics.

Deleting One Patient Se l e c t Pa t i e n t 0 2 0 1 5 _ 2 1 1 2 9 5P3 1 2 3 4 J OHNSM I T H

I D <

↓

Select the appropriate patient. Se l e c t De l e t e Op t i o n > Re s u l t s o n l y Pa t i e n t & Re s u l t s Selecting Results only will delete the results for this patient but not the patient demographics. Selecting Patient & results will delete this patient and the associated results.

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USING THE VITALOGRAPH 2120 WITH SPIROTRAC 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 hand-held device to the cradle with the coily cable as illustrated below. Then connect the cradle to the PC with the 9 way to 9 way serial cable.

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

CLEANING AND DISINFECTING THE VITALOGRAPH 2120 Part

Material

Cleaning

Disinfecting

Case exterior

A.B.S.

Lint-free damp cloth. Ambersil. Do not use solvents.

Mild liquid disinfectant wipe over.

Flowhead cone

T.P.X.

Mild detergent. Flush with clean water. Brush off any deposits. Dry thoroughly.

Flowhead mesh

Acetal and polyester

Disposable

Mild liquid disinfectant. Flush with clean water. Dry thoroughly. Autoclaving (15 minutes @ 134°C) Disposable

End cap

T.P.X.

Mild detergent. Flush with clean water. Brush off any deposits. Dry thoroughly.

Mild liquid disinfectant. Flush with clean water. Dry thoroughly. Autoclaving (15 minutes @ 134°C).

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