Vitalograph logo
micro

Model 6300

User Training Manual

Device illustration

CE


 

 

Vitalograph Ltd. UK

Maids Moreton, Buckingham, MK18 1SW, England
Phone: (01280) 827110
Fax: (01280) 823302
e-mail: sales@vitalograph.co.uk
www.vitalograph.co.uk

Vitalograph Ltd. Export

Maids Moreton, Buckingham, MK18 1SW, England
Phone: +44 1280 827120
Fax: +44 1280 823302
e-mail: sales@vitalograph.co.uk
www.vitalograph.eu

Vitalograph Ltd. Hong Kong
Unit 230, Corporation Park, 11 On Lai Street, Shatin, Hong Kong
Phone: +852 2117 2678
Fax: +852 2117 2679
Email
: sales@vitalograph.hk
www.vitalograph.hk

Vitalograph GmbH
Rellinger Straße 64a, D-20257 Hamburg, Germany
Phone: (040) 547391-0
Fax: (040) 547391-40
e-mail: info@vitalograph.de
www.vitalograph.de

Vitalograph Inc.
13310 West 99th Street, Lenexa, Kansas, 66215, USA.
Toll Free: 800 255 6626
Phone: (913) 730 3200  
Fax:
(913) 730 3232
e-mail: vitcs@vitalograph.com
www.vitalograph.com

Manufacturer symbol Vitalograph (Ireland) Ltd.
Gort Road Business Park, Ennis, V95 HFT4,
Co. Clare, Ireland
Phone: +353 65 6864100  
Fax: +353 65 6829289
e-mail: sales@vitalograph.ie
www.vitalograph.ie

© Copyright Vitalograph 2016
Current Edition (Issue 5)
Cat. No. 07687

Vitalograph logo is a registered trademark

 

 


 

Table of Contents

  1. Description of the Vitalograph micro
    1. Indications for Use
  2. Contraindications, Warnings, Precautions and Adverse Reactions
  3. Main Components of the Vitalograph micro
  4. Features of the Vitalograph micro
  5. Getting the Vitalograph micro ready for use
  6. Power Management in the Vitalograph micro
    1. Battery Pack
    2. Battery Low Detect
    3. Power Save Mode
  7. Operating the Vitalograph micro
    1. Main Menu
    2. New Subject Information
    3. Performing a Test Session
    4. Performing a Post Test Session
    5. Configuration Menu
    6. Reports and Printing
    7. Storing Results
    8. Accuracy/Calibration
    9. Setting up a New Flowhead
  8. Cleaning Instructions
    1. Cleaning and Low Level Disinfection of the Vitalograph micro
    2. Disassembling and Cleaning of the Fleisch Flowhead
    3. Reassembling and Low Level Disinfection of the Fleisch Flowhead
  9. Fault Finding Guide
  10. Customer Service
  11. Consumables and Accessories
  12. Explanation of Symbols
  13. Technical Specifications
  14. CE Notice
  15. FDA Notice
  16. Declaration of Conformity
  17. Guarantee


1. Description of the Vitalograph micro

The Vitalograph micro is a handheld spirometer designed for use by trained professionals in the doctor's office, clinic, hospital department, etc. for measuring and archiving tests on human subjects. Demographic data is entered via a keypad and stored, together with spirometry test data. Current test data can be viewed on the screen and downloaded/printed via a PC. There are a variety of configuration options available.

Information about the device can be obtained from the About box. This information can be used if any queries are made to Vitalograph or a service agent.

To access the About box:

  1. Press the Configuration button from the Main Menu .  Configuration button
  2. Press the About button.  About box

1.1 Indications for use

The device is a spirometer which measures patient respiratory parameters including FVC, FEV1, FEV6, PEF, MVV and VC. The Vitalograph micro is a handheld spirometer designed for lung function testing for use on adults and pediatrics, 5 years and older, in a variety of environments such as hospital wards, health centers and private homes under the supervision of a healthcare provider.

2. Contraindications, Warnings, Precautions and Adverse Reactions

  1. No modification of this equipment is allowed. Any unauthorised changes to the Vitalograph micro device may compromise product safety and/or data and as such Vitalograph cannot be held responsible and the device will no longer be supported.
  2. The Vitalograph micro is not designed as a sterile device. Always follow the safety guidelines given by the manufacturer of cleaning and disinfectant chemicals.
  3. The Vitalograph micro is not IP rated or designed to be waterproof in any way. Care should be taken to follow the recommended instructions in section 8 when cleaning the flowhead. 
  4. For spirometry testing a new Bacterial Vital Filter (BVF) should be used for each subject to protect both device and subject. A BVF is for single subject use only. A delay of at least 5 minutes should be allowed between subjects to allow settling of previously aerosolized particles in the measuring device.
  5. Spirometry may support or exclude diagnosis, but it cannot make one (ATS/ERS 2005).
  6. Take care not to block the mouthpiece with the tongue or teeth during testing. A 'spitting' action or cough will give false readings.
  7. All values displayed by the Vitalograph micro are expressed as BTPS values. 
  8. Time zero is determined using the back-extrapolated method, from the steepest part of the curve. 
  9. Subject fatigue may occur during spirometry testing depending on the subjects characteristics e.g age, health status. To avoid this the subject may sit during the testing or alternatively take a break between tests. A subject fatigue warning will appear after 8 manoeuvres and the maximum number of allowed manoeuvres in one session is 20.
  10. All spirometry standards recommend checking the accuracy of lung function measuring devices at least daily with a 3-L syringe to validate that the instrument is measuring accurately. The Vitalograph micro should never be outside accuracy limits. In normal use, calibration traceability certification is recommended as a part of the routine annual service. Accuracy should also be checked after cleaning or disassembling the spirometer for any reason, after adjusting calibration or if the flowhead or device has been dropped.
  11. After fitting a New Flowhead to the Vitalograph micro it is necessary set-up the flowhead with the device. The procedure is outlined below.
  12. Service and repairs should be carried out only by the manufacturer or by Service Agents specifically approved by Vitalograph.
  13. Per section 13 Technical Specifications below only IEC60086 Certified AAA batteries should be used with the micro device. See section 11 Consumables and Accessories for a list of certified batteries approved for use. 
  14. Per section 14 below 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. If interference is suspected or possible, switching off the offending device is the normal solution, as is required in aircraft and medical facilities. NON MEDICAL EQUIPMENT MUST BE KEPT OUTSIDE THE PATIENT ENVIRONMENT. Portable and mobile RF communications equipment can affect medical electrical equipment.

3. Main Components of the Vitalograph micro

The main components for the Vitalograph micro are shown below.

Figure 1


A
PC Software
B
Flowhead
C
Flowhead Release Button
D
LCD/Touch Panel Display
E
Mini USB Port
F
On/Off Button
G LED
H Battery compartment (4 x 1.5V AAA Batteries)



4. Features of the Vitalograph micro

The Vitalograph micro features include:


5. Getting the Vitalograph micro Ready For Use

  1. Insert 4 x 1.5V AAA batteries into the battery compartment on rear of device. Alternatively the Vitalograph micro device may be powered from the USB cable supplied with the device. Connect one end of the USB cable into an available USB connection on a PC and the other end into the USB connection on the device.
  2. Connect a BVF to the flowhead.
  3. Press the On/Off switch on the front face of the instrument to turn the device on and the Vitalograph micro is ready for use.

6. Power Management in the Vitalograph micro

The Vitalograph micro can be powered from the PC via the USB cable or from the internal batteries. The LED on the front face of the device and the battery power icon show the power status of the device.

When powered from USB power this icon USB power connectedwill be displayed on the status bar at the top of the screen.  

6.1 Batteries

The Vitalograph micro uses 4 x 1.5V non-rechargeable IEC680086 certified AAA alkaline batteries. This allows the device to be used without the USB cable connected to the device.

 

6.2 Battery Power Indications

The Vitalograph micro has a number of battery power indications:





When the batteries are full the Green Battery full Icon is displayed on the Main Menu screen device.
When the USB power is connected a Plug Icon is displayed.
The LED will stay Green for both full batteries and USB power.

When the batteries start to run low the Battery Low Icon is displayed and both it and the LED will turn orange.
You will be allowed to continue to use the device. It is advised that you prepare to change the batteries or plug in the USB cable connected to a computer and continue testing.


When the batteries are approaching fully discharged the Battery Discharged icon will be displayed on the full screen on power up and on the main screen status bar and both it and the LED will turn red.
It is advised that you change the batteries or attach to a PC using a USB cable to continue testing

 

6.3 Power Save Mode

In order to improve battery life, when powered by batteries only and left unused the screen on the Vitalograph micro device will dim after 30 seconds, go blank after 60 seconds and the device will auto power down if left unused for 2 minutes. 

When running off of the USB the screen on the Vitalograph micro device will go blank if left unused for 5 minutes. The device will not auto power down if powered by USB.

Pressing the On/Off button will bring the device out of power save mode.


7. Operating the Vitalograph micro


After turning on the device for the first time you are presented with the Setup screen for the Date and Time.


 

Enter the current time and date using the up/down buttons.
Press the enter button  to save these settings and continue onto the  Main Menu screen.


7.1 Main Menu

The Main Menu screen includes the following options - New Subject, VC Test, FVC Test and Post Test.



When turning the device on for the first time the test screen icons will appear greyed out and can't be selected until a subject is created. The Post Test icon will stay greyed out until an FVC pre-test is performed.

In addition to displaying the time and the battery icon the status bar at the top on the screen will show various icons to indicate the following:
  1. V - indicates a VC test has been performed
  2. F - indicates an FVC has been performed
  3. P - indicates post mode
The icons will only appear after the test has been completed.

7.2 New Subject Information

  1. Select the New Subject button on the Main Menu, to bring you into the New Subject screen .
  2. The Subject information fields available are as follows -                                                                       Age Age  HeightHeight Gender female Gender maleGender WeightWeight Population group  Population             
  3. Age, Height and Gender are on the first screen and are enabled by default. Weight and Population Group are on the second screen and are not enabled by default. They have enable options in the configuration menu - Subject Options
  4. To enter information for Age, Height and Weight just touch on the box and type in the information using the touch panel keypad. Units will  automatically switch between cm/kg and in/lbs. The Gender is selected by pressing the appropriate option male Maleor female Female.           The Population Group is selected from a list by pressing the appropriate option on screen. To access additional Population Groups select the arrow on the right of the screen.  
  5.  Press the Enter button to save the subject to the database and return to the Home Menu.
  6. If a value is not entered for Age, Height or Gender then an Error Icon will appear next to the empty field when the enter button is pressed, this is to indicate that the predicted values will not appear in the results of any testing done. To exit the new subject screen press the enter button again.                     
Note:  With the exception of the first use of the device or after clearing the memory, when the user enters the New Subject Screen the details will appear greyed out. If the user hits the Age, Height or Weight box it will jump into the Data Entry screen and will clear the data to allow the user to enter new data. When the user returns to the New Subject screen all the other fields will be cleared. The user will need to enter all subject details or an error icon will appear.  


7.3 Performing a Test Session

7.3.1 Checks to Make before Performing a Test Session

Before starting a test session, there are a number of checks which should be made:

  1. Ensure that the accuracy of the Vitalograph micro unit was checked recently. (Refer to the section on Checking Accuracy)
  2. Ensure a subject is created and the required demographic information is entered for the subject. A test session can be performed without filling in any details for the subject but is advised to do so.  
  3. Fit a disposable BVF mouthpiece to the flowhead. The use of a disposable noseclip is also recommended.

7.3.2 Performing a VC Test

Perform the VC test as follows:

  1. Select the ‘VC Test’ option from the Main Menu  .
  2. Wait for the ‘Exhale to Begin’ icon to appear .This indicates that the Vitalograph micro unit is ready to accept a blow.
  3. The results may be viewed as either a Volume/time (V/t) or Volume Bar graph by pressing the graph button on the side of the test screen. These are not enabled during test.    Volume time Volume/time (V/t) Volume bar graph Volume
  4. The graph may be changed to a full screen graph by using the zoom button on the side of the test screen. To return to normal mode select the zoom in button. These are not enabled  during test.  
  1. Perform VC test. Additional guidance on performing Spirometry Manoeuvres can be found on the Vitalograph website.
  2. Repeat the blow three times or more to obtain good test quality.
  3. The results summary on the bottom of the screen shows the VC of the last blow.  The number of blows is shown in a separate box next to the last test VC. 
  4. If you wish to delete the current blow you can do this as follows: 
    1. Following completion of the blow you wish to clear, select the Delete option from the menu on the side of the test screen.
    2. Two Delete icons will appear in the same area on the side of the test screen, one Delete with a green tick and the other Delete icon with a red 'X'. To confirm the deletion of the blow press the Delete icon with the green tick. To cancel the deletion select the Delete icon with the red 'X'.
    3. If you wish to clear/delete all the sessions on the device you may connect to Vitalograph Reports as outlined in section 6.5 and move all data to Vitalograph Reports and clear it from the device. 
  5. After performing the VC tests press the enter button to exit the VC Test screen. This brings you back to the Main Menu.

7.3.3 Performing an FVC Test

  1. Select the ‘FVC Test’ option from the Main Menu
  2. Wait for the ‘Exhale to Begin’ icon to appear . This indicates that the Vitalograph micro unit is ready to accept a blow.
  3. The results may be viewed as either a Volume/time (V/t) or Flow/Volume (F/V) graph by pressing the graph button on the side of the test screen. These are not enabled during test. V/t Graph Volume/time (V/t) F/V graph   Flow/Volume (F/V)                                                                                       
  4. The graph may be changed to a full screen graph by using the zoom button on the side of the test screen. To return to normal mode select the zoom in button. These are not enabled  during test.