Vitalograph Alpha 6000 User manual

ALPHA

Instructions for Use

MODEL 6000

A Global Leader in Respiratory Solutions

2Page of 2

ENG

DT_0006 Issue 15

Vitalograph Ltd, UK

Maids Moreton, Buckingham

MK18 1SW

England

Tel: 01280 827110

Fax: 01280 823302

E-mail: [email protected]

www.vitalograph.co.uk

Technical Support

Tel: 01280 827177

Email: [email protected]

Vitalograph Ltd, International

Maids Moreton, Buckingham

MK18 1SW

England

Tel: +44 1280 827120

Fax: +44 1280 823302

E-mail: [email protected]

www.vitalograph.eu

Technical Support

Tel: +353 65 6864111

Email: [email protected]

Vitalograph GmbH

Rellinger Straße 64a

D-20257 Hamburg

Germany

Tel: +49 40 547391-40

Fax: +49 40 547391-40

E-mail: [email protected]

www.vitalograph.de

Technical Support

Telefon: +49 40 547391-14

E-mail: [email protected]

Vitalograph Inc.

13310 West 99th Street

Lenexa, Kansas, 66215

USA

Toll Free: 800 255 6626

Tel: (913) 730 3200

Fax: (913) 730 3232

E-mail: [email protected]

www.vitalograph.com

Technical Support

Tel: (913) 730-3205

Email: [email protected]

Vitalograph (Ireland) Ltd

Gort Road Business Park

Ennis, Co Clare, V95 HFT4

Ireland

Tel: +353 65 6864100

Fax: +353 65 6829289

E-mail: [email protected]

www.vitalograph.ie

Technical Support

Tel: +353 65 6864111

Email: [email protected]

Vitalograph Ltd, Hong Kong/China

P.O. Box 812

Shatin Central Post Oce

Hong Kong

E-mail: [email protected]

www.vitalograph.cn

Technical Support

Tel: +353 65 6864111

Email: [email protected]

Current Edition (Issue 1, 29-Nov-2019)

Cat. No. 09080

Vitalograph is a registered trademark.

Vitalograph Branch Addresses

09080 Issue 1

3Page of 32

ENG

ALPHA - Instructions for Use

Contents

1. Main Components of the Vitalograph ALPHA..................................4

1.1. Features of the Vitalograph ALPHA .........................................4

2. Setting Up the Vitalograph ALPHA ...................................................5

2.1. Fitting a New Paper Roll............................................................6

3. Operating Instructions .......................................................................7

3.1. Entering Subject Data................................................................7

3.2. Conducting a Test......................................................................8

3.3. Reporting..................................................................................10

3.4. Deleting Stored Subjects/Test Results ..................................10

3.5. Calibration Verication............................................................11

3.6. Conguration Options .............................................................11

4. Power Management.........................................................................14

4.1. Battery Pack............................................................................14

4.2. Battery Low Detect ..................................................................15

5. Cleaning & Hygiene ..........................................................................16

5.1. Preventing Cross-Contamination of Subjects........................16

5.2. Inspection of the Vitalograph ALPHA ....................................16

6. Fault Finding Guide ..........................................................................17

6.1. Software Check........................................................................18

7. Customer Service.............................................................................19

8. Consumables and Accessories.......................................................19

9. Disposal ............................................................................................19

10. Explanation of Symbols ...................................................................20

11. Description of the Vitalograph ALPHA ...........................................21

11.1.Indications for Use ..................................................................21

12. Technical Specication....................................................................22

13. Contraindications, Warnings, Precautions

and Adverse Reactions ....................................................................24

14. CE Notice ..........................................................................................26

15. FDA Notice........................................................................................28

16. EU Declaration of Conformity..........................................................29

17. Guarantee .........................................................................................30

A Global Leader in Respiratory Solutions

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DT_0006 Issue 15

1. Main Components of the Vitalograph ALPHA

Figure 1 Main components of ALPHA

Note: Computer not supplied

1 Display

2Internal Thermal Printer

3 Flowhead

4Flowhead Connection Tubing

5 Medically Approved Power Supply

6 BVF™

7 USB Cable

8 Vitalograph Reports Software (Optional)

09080 Issue 1

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ENG

ALPHA - Instructions for Use

1.1. Features of the Vitalograph ALPHA

• Fleisch type pneumotachograph to measure ow

• Ambient temperature sensor

• Keypad with extra-large buttons

• Integral printer

• Storage of tests and demographic information

• Ability to exchange information with a computer

2. Setting Up the Vitalograph ALPHA

1. Unwrap silicone twin tubing and connect one end to the ALPHA base. The

tubing is ribbed on one side. Ensure that the coloured/ribbed tapping on the

owhead is connected to the ribbed side of the connection in the housing.

2. Connect other end of owhead tubing to the owhead.

3. Connect the power supply into the rear of the ALPHA. Plug the mains plug

into a suitable socket. Switch the ALPHA on (switch at rear) and it is ready

for use.

Note: Only use the ALPHA with the purpose-built low voltage power supply unit

with which it is supplied. Attempted use with other power sources may cause

irreparable damage and invalidate the warranty.

4. The ALPHA comes tted with a rechargeable battery pack, which allows the

device to be used as a portable device without the mains connected.

5. The ALPHA can be connected through the USB port at the side of the unit

to the user’s computer, so that the report can be written to the Vitalograph

Reports Utility (refer to the Vitalograph Reports Instructions for Use)

6. The Vitalograph ALPHA may be used as a owhead for testing with

Spirotrac® software (purchased separately, see Spirotrac IFU for how to do

this).

If the device has just been unpacked or transported, ensure that it is left sitting,

fully powered so that it is at room temperature prior to testing.

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ENG

DT_0006 Issue 15

2.1. Fitting a New Paper Roll

The ALPHA is supplied with a roll of paper tted into the printer.

Note: Paper is light sensitive so the outside of the roll of paper will not give a

strong print impression.

To replace the paper (see Figure 2):

1. Open printer door to expose the head of the printer and the paper

cartridge.

2. Take out the cartridge that holds the empty paper roll and remove the

empty roll.

3. Put new roll of paper into the paper cartridge and unroll about 12cm (6

inches) of paper.

Note: To make tting easier, create a point in the middle of the paper by tearing

or cutting the two corners of the leading edge of the paper.

Note:The Vitalograph logo should be facing you on the right edge of the

paper.

4. Clip the paper cartridge back into place between the back of the

ALPHA and the inside of the open door. The paper should come out

from the bottom of the roll and point towards the printer. This allows

more access to the printer feed mechanism.

5. In the home screen, lift the green lever on the printer.

6. Feed the leading edge of the paper into the bottom slot of the printer

until the paper appears through the top of the printer. The paper can

now be pulled through. To feed the paper through the printer, press the

‘Enter’ key on the keypad. This will feed a short length of paper through

the printer.

7. Close the green lever.

8. Hold the paper over the paper tear bar and close the door.

Figure 2 Fitting a new paper roll.

Warning: The paper tear bar has sharp edges. Take care not to cut ngers.

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ALPHA - Instructions for Use

3. Operating Instructions

Turn on the ALPHA (the On/Off switch is at the back of the device).

3.1. Entering Subject Data

After a short delay, the Welcome screen displays briey. This is followed by a

screen for entering a new subject’s detail showing the rst eld to be entered.

Enter a number for the subject ID, then press the ‘Enter’ key. Enter number for

age, then press the ‘Enter’ key. Repeat for all elds. Dialog boxes appear one at

a time in the following order:

1. Reference Number

2. Age

3. Height

4. Gender

5. Ethnicity

6. Weight

7. Smoking History

Use the Delete key to remove data, then enter new information. Press the Delete

key repeatedly to step back through the dialog boxes. When subject information

is complete and correct, press the Enter key twice to return to theMain Menu.

The Subject Information will be printed to the internal printer unless printing is

deselected.

This screen may be by-passed to access the Main Menu screen directly by

pressing the Enter key 3 times (e.g. for calibration verication before patients

arrive).

Note: Ethnicity categories may differ between device variants. Weight and

Smoking History elds are not available in all variants of the ALPHA.

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DT_0006 Issue 15

To enter another subject’s details, select the ‘New Subject’ option from theMain

Menuusing the keypad. A dialog box will appear to conrm whether to clear

current subject details.

• Press ‘Yes’ to open New Subject screen and enter thenew subjectdetails.

• Press ‘No’ to return to Main Menu.

3.2. Conducting a Test1

Before starting a test session:

1. Ensure that the accuracy of the device was checked recently. (Refer to

section: “Calibration Verication”).

2. Select a subject and ensure the required demographic information is

entered.

3. Wash hands (operator and subject).

4. Fit a new Bacterial Viral Filter (BVF) to the owhead for each test

subject. The use of a disposable noseclip is recommended.

5. Instruct and demonstrate the test.

3.2.1. Testing

1. Select either the ‘VC Test’ or ‘FVC Test’ option from the Main Menu.

2. Select how the results should be presented:

• VC Test – Press key 1 for Volume/Time (V/T) graph and key 2 for

Volume (Bar Chart).

• FVC Test - Press key 1 for Volume/Time (V/T) graph and key 2 for

Flow/Volume (F/V) graph.

3. Wait for the ‘Exhale to Begin’ icon to appear. The

device is now ready to accept a blow.

Example script:

• Sit upright, t the nose clip and relax.

• Place BVF in mouth and close lips around the mouthpiece.

• Seal your lips around the mouthpiece and keep your tongue down.

• Breathe normally.

VC test session:

a. Inhale completely with a brief pause when your lungs are completely full

(≤ 2 secs).

b. Exhale with no hesitation until no more air can be expelled while

maintaining an upright posture. It is vital that the operator encourages the

subject to keep exhaling to ensure all air is expelled (when a plateau has

been reached or forced expiratory time (FET) reaches 15 seconds). The

operator should repeat instructions as necessary, coaching vigorously

c. Listen for two beeps. This indicates that device is ready for the next blow.

1 Derived from terminology and guidance taken from ATS/ERS Standardisation of Spirometry 2019 Update Am J Respir Crit Care

Med 2019 Vol 200, Iss 8 pp e70-e88

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ALPHA - Instructions for Use

d. Repeat for a minimum of three manoeuvres, usually no more than eight

for adults.

e. Check VC repeatability and perform more manoeuvres as necessary.

Note: A single-breath VC technique may also be performed on the device.

FVC test session:

a. Inhale completely and rapidly with a brief pause when your lungs are

completely full (≤ 2 secs).

b. Exhale with maximal effort until no more air can be expelled while

maintaining an upright posture.

It is vital that the operator encourages the subject to keep exhaling to ensure all

air is expelled (when a plateau has been reached or forced expiratory time (FET)

reaches 15 seconds). The operator should repeat instructions as necessary,

coaching vigorously

c. Breathe in with maximal effort until completely full. The manoeuvre is

now complete and the BVF is removed from the mouth.

d. Listen for two beeps. This indicates that device is ready for the next blow.

e. Repeat for a minimum of three manoeuvres, usually no more than eight

for adults.

f. Check FEV1and FVC repeatability and perform more manoeuvres as

necessary.

Note:A single-breath FVC technique may also be performed on the device.

3.2.2. Saving the Test Session

1. Select ‘Post Mode’ from the main menu using the keypad.

2. Select ‘Save Current Subject Pre Test’ from the post mode screen

using the keypad. An information dialog box will appear showing the

memory location where the test session will be saved. There are nine

memory locations on the ALPHA. The best three tests will be saved.

Note:If a Compact Flash card is inserted into the Compact Flash connector at

the right side of the device, then all test blows and not just the best three will be

saved to the compact ash card. Results are saved as per the format outlined in

the ERS/ATS Task Force Report on Standardisation of Lung Function Testing

(2005)2.

3.2.3. Bronchodilator Responsiveness Testing

A Bronchodilator Responsiveness Test session can be performed on an

FVC test session following the administration of drugs. Post drug delivery

performance is measured versus pre delivery.

To perform a Bronchodilator Responsiveness Test select ‘Post Mode’ from

themain menuusing the keypad:

1. To perform a Bronchodilator Responsiveness Test on the Pre-test

Session just performed, select ‘Set Post Mode for Current Subject’.

The device will return to theMain Menuscreen with the text ‘Post

2 ATS/ERS Standardisation of Spirometry Eur Respir J 2005; 26: 319–338

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DT_0006 Issue 15

Mode’ in the top right-hand corner of the screen.

2. To perform a Bronchodilator Responsiveness Test on a different

subject or Pre-test:

a. Select, ‘Select a Subject’ from the Pre-Store.

b. A message ‘Warning! Current Results will be cleared’ will appear.

Select ‘Yes’ and theSelect Subjectscreen opens.

c. Select the number of the Pre-test for which Bronchodilator

Responsiveness Testing is required. The device will return to

thePost Modescreen.

d. Press Enter to return to theMain Menuscreen.

Perform the Post VC and/or Post FVC test as outlined in section, Performing a

Test Session.

Note:If there is no Pre-Test saved, the message No FVC Tests Performed will

appear.

3.2.4. Viewing Current Subject Details

To view the Current Subject details:

1. Select ‘Post Mode’ from theMain Menuusing the keypad.

2. Select ‘View Current Subject’ from thePost Modescreen.

3. TheCurrent Subjectscreen displays.

Note:It is not possible to modify any of the subject details.

3.2.5. Deleting a Test Session

To delete the current session:

1. Select the ‘Clear Results’ option from theMain Menuusing the

Keypad.

2. A message will appear ‘Warning!Current Resultswill be Cleared. Do

you wish to proceed?’ Select ‘Yes’ to delete the current results or ‘No’

to cancel the delete. Screen returns to theMain Menu.

3.3. Reporting

Select Print from theMain Menu to print the current test session.

The information printed on the session report can be congured to suit user

requirements. Refer to the section onReport Options.

Note:The internal (thermal) printout will fade over time when exposed to light

or heat. If a permanent record is required, photocopy the thermal printout

or send the report to the Vitalograph Reports Utility. Refer to the section

onCongurationfor information on selecting the internal or Vitalograph Reports

Option.

3.4. Deleting Stored Subjects/Test Results

To delete individual Stored Subjects/Test results:

1. Select ‘Post Mode’ from theMain Menuusing the keypad.

2. Select ‘Delete Stored Tests’ from thePost Modescreen. A list of

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