SPIROLAB

SPIROLAB

USING THE SPIROLAB

TURNING THE SPIROLAB ON AND OFF

To turn the spirolab on, press then release the button on the front of the unit.

When you turn on the device, the first screenshot shows the internal software loading progress.

Only the first time the device will ask the user to protect the access with a PIN:
According to GDPR (General Data Protection Regulation) the user, can do this by inserting a PIN.

Press OK if you want to set a personal PIN or

Press Undo to skip this function.

Pressing OK then a message requires to confirm the use of a PIN: press OK to continue or Undo to skip this function.


  1. Press OK on the following screen
  2. The PIN must have 4 numbers.
  3. Insert a PIN in the field “New PIN” using the numeric keyboard,
  4. Repeat the PIN in the field “Confirm new PIN”.
  5. If the PIN is correct a popup will appear with the following message:
         Change PIN Successful
  1. Press OK
  2. Press  to return to the main screen.

From this moment each time the device is switched on the PIN needs to be inserted.

If the PIN is incorrect the user can try again; (the device allows 20 attempts per day).
After 20 attempts the user needs to wait for the next day to unlock the device.


If the user forgot the PIN send an inquiry to the following website: www.spirometry.com/getpin

Complete the fields and insert the DEVICE ID shown on the popup on the screen.
After the registration the system will send an e-mail to the address inserted on the web site with the PIN to unlock the device.

At the end the main screen will appear


To turn spirolab off, press the power button on the front of the unit

 WARNING

Spirolab does not turn off completely but enters an ultra-low standby mode; some features remain active to allow the device

to keep the date and time updated and to be activated remotely if required. For this reason, the power key's symbol is , corresponding to the standby mode.

Saving energy

The internal battery pack charge is shown in the upper right hand corner of the display by the symbol:


If the battery symbol is all green, then the battery pack is charged.

 WARNING
To charge the battery pack, only use the charger supplied by the manufacturer.

MAIN SCREEN

The device’s features can be accessed from the main screen. The following section details the features of each icon.


SYMBOLS AND ICONS

The following table shows the icons displayed on the various screens and what they mean
ICON
DESCRIPTION

To access initial settings

To enter new patient data

To edit patient data/To rerun an achieved patient test

To access file containing tests performed

To save the settings and return to the main screen

To exit without save and return to the previous screen

To view the last spirometry session for the current patient

To view the last oximetry session for the current patient

To test oximetry

To test FVC spirometry

To test VC spirometry

To test MVV spirometry

To run a bronchodilator test (POST)

To check the alarms and thresholds settings during an oximetry test

To indicate the oximetry sensor is properly connected during testing

To indicate that the finger is inserted properly

Acoustic alarm alert active. Press to mute for 2 minutes

To print a test

To delete a test

To cancel an operation

SERVICE MENU

To access the menu, press the icon .
To view headings, enter the PIN set or, if was not inserted a personal PIN, enter the default PIN which is the following: 1223

If the personal PIN is missed touch the ? to unlock the device sending an enquire on the internet site described before.

In this screen, you can also change the brightness of the display by tapping the orange cursor vertically. The brightness will change in real time.

The service menu will display the following heading sequence:

  1. Device
  2. Spirometry
  3. Calibration
  4. Oximetry
  5. References
  6. Delete archive
Tap the desired heading to select it.

Device

The section is divided into:
  1. General
  2. Date/Time
  3. Info
  4. Printer
  5. Privacy
Select the desired settings by tapping the white box; the selection is highlighted by an orange box.
For the brightness of the display, move the orange cursor vertically until the desired brightness.

To set the correct date and time, tap the box to bring up the cursor; use the numeric keypad on the lower right to set the correct value. The area “Daylight saving time” allows to set the automatic time change depending on the geographic area which you stay. The device recognizes the date changes until 2026.

The "Info" section displays the hardware and software versions of the device's most significant components, in addition to the serial number.
In the "Printer" section, you can set the print header. Tap the white space under "printout header" to bring up the virtual numeric keyboard. You can enter characters until the string is complete.
In the area “External printer” it is possible to enable or disable the external printout via USB connection, or to choose the printing colour type in case of use of the external printer via USB. The printer to use must be postscript type.


In the “Privacy” section the user can enable or disable:
  1. the PIN
  2. the Privacy information
The device has a default PIN set, which is the following:

1 2 2 3

 

In this section it is possible to change the PIN enabling “Change PIN”.

On the screen a numeric keyboard will appear with the fields to change the PIN.

Spirometry

The section is divided into:
  1. Parameters
  2. Outcome
  3. Incentives
In the “Parameters” section, you can select the values that will be displayed at the end of a test; these will be stated on the printout. Here too, the selection is highlighted by an orange box.

In the “Results” section, you can choose what to include in the printout from among the following items:

  1. Best values
  2. Interpretation of spirometry results
  3. F/V (expiratory + inspiratory) and V/t curves
  4. F/V expiratory only curve and V/t curves
This section allows to choose the unit of measure to show the PEF value: L/sec or L/min


In the "Incentive" section, you can configure the paediatric incentive to improve spirometric performance.
The incentive may be enabled or disabled; should it be enabled, by selecting "ON" on the left, you must enter the age threshold up to which the incentive is displayed; use the numeric keypad on the bottom to set this value.


Calibration

Calibrating turbines
 WARNING

The turbine does not need calibration, just a periodical clean.

The disposable turbine is inspected before it is sealed in the package, and hence does not need calibration.

If, however, if you want to carry out a calibration, bear the following in mind.

Calibration can be carried out on reusable and disposable turbines.
Calibration takes place based on the FVC (expiratory) and FIVC (inspiratory) values measured during a test performed with a calibrated syringe.
To access the calibration setting, select the service menu item "Calibration"; the first screen, "Last values", allows you to check current percentages applied by the device.

By choosing "New calibration", you can calculate new conversion factors. Make a test using the syringe calibration.

Make the following acts in the same sequence:

  1. Make an inspiration manoeuvre
  2. Make an expiration manoeuvre
  3. Make an inspiration manoeuvre once again
    1. In the syringe maneuver, the flow must enter within the red lines.
    2. you start with a very low flow
    3. intermediate flow
    4. high flow until the red lines are covered. On the display it is shown the graphic of the test.
Then tap .

by setting the  for example 300 (cL) shows the following screen

Set by entering the data related to the parameters:

  1. Pressure
  2. Temperature
  3. Humidity

If calibration correction is < 10% then the values are shows as in the following screen.

Tap “OK” to set the new correction values.

If the values are > 10 % then the following message appears on the screen:




The FVC and FIVC values are not accepted. This means that the system is unable to correct such a large calibration error. In this case:
  1. check that the spirolab is working properly by fitting a new turbine and/or
  2. clean the turbine in question.
To cancel the calibration in use and restore the factory settings, select “Factory values” from the calibration menu.
Then tap .

 WARNING

According to the "Standardised Lung Function Testing" publication of the European Respiratory Society (Vol 6, Supplement 16, March 1993), air expelled from the mouth has a temperature of about 33/34°C.

To convert the volumes and air flow rates to BTPS (37 °C) conditions, they must be increased by a factor of 2.6%. The BTPS factor for a temperature of 33°C is 1.026, which is in fact a correction of 2.6%. In practice, the BTPS factor for expiratory volumes and flow rates is constant and equal to 1.026.

The BTPS factor for inspiratory volumes and flow rates depends on ambient temperature, as air that is inhaled is at that temperature.

For instance, with an ambient temperature of 20 °C with Relative Humidity of 50%, the BTPS factor is 1.102, which represents a correction of +10.2%.

The correction of inspiratory volumes and flow rates is performed automatically thanks to an ambient temperature sensor that measures the temperature inside the device and allows the BTPS factor to be calculated.

If a 3-litre syringe is used for the test and if the spirolab device is perfectly calibrated, the FVC (syringe) value measured will be:

3.00 (FVC) x 1.026 (BTPS) = 3.08 L (FVC at BTPS).

If the ambient air temperature is 20 °C, the FIVC (syringe) value measured will be:

3.00 (FIVC) x 1.102 (BTPS) = 3.31 L (FIVC at BTPS).

The user must be aware that the volume of the syringe shown was converted to BTPS and the "alterations" of the results when compared with expected values do not therefore represent an error.

For example, if you perform calibration with the data measures:

FVC = 3.08 L and FIVC = 3.31 L at an ambient temperature of 20 °C, the correction coefficient will be:

EXPIRATORY                   .00%

INSPIRATORY                 .00%

To repeat, this is NOT an error but the logical consequence of what was explained above.


NOTE

Calibration can also be performed using the MIR Spiro software. For details about the calibration procedure using this software, refer to the MIR Spiro online manual.


OXIMETRY

Access to these settings is password protected and it is possible to configure both the physiological alarms - the lower and upper threshold values of the SpO2 and Pulse Rate parameters - and the technical alarms

By setting the physiological alarms to "ON", the box is enabled to set the threshold value using the numeric keypad.


 WARNING

If the maximum value of a parameter is less than or equal to the minimum value, the setting process will not proceed. A beep will sound and the device will automatically return to the screen for setting the minimum value.


REFERENCES

This section allows you to set the predicted value used between:

Adults

Children

ERS

Knudson

Knudson

Knudson

USA

Knudson

ERS

Zapletal

MC-Barcelona

Zapletal

JRS-JAPAN

JRS-JAPAN

Chinese H.K.

Chinese H.K.

Pereira

Pereira

CECA1971

Knudson

NHANES III

NHANES III

GLI

GLI

Padilla-Perez

Knudson

If you choose the last predicted value NHANES III, the limitations provided for in the past by the standard NHANES III will be applied.
 WARNING

If you set the predicted value NHANES III are disabled the VC and MVV tests.


Delete Archive

Using the numeric keyboard, enter the PIN set to permanently delete all the tests stored in the device.

PATIENT DATA

From the main screen, you can access the patient data management area:
create a new patient profile or check for existing patients in the archives

change current patient data

ENTERING PATIENT DATA


This screen provides access to all patient data. The ID code is not mandatory. Tap the grey space to access the various fields and make entries using the virtual keyboard on the screen. Selecting “Personal Best” the patient will be managed using the special predicted values defined by the physician; for ore details concerning the Personal best management, please refer to additional information at the end of this point.

Tapping the "Origin" field brings up a drop down menu where you can choose the desired value.

The icon  allows you to delete the last character entered.


The icon  allows you to enter uppercase characters
The icon  allows you to enter information in the next field
The icon  allows you to return to the main screen without saving data
The icon  allows you to save your entries and return to the main screen
 WARNING

The data required to create a patient profile is:

  1. name
  2. surname
  3. sex
If any of these items of information are not inserted, the patient profile is not created when you tap

In the "Origin" field, the following options will appear:

ATS/ERS standards

 

 

NHANES III standards

Group

% correction

 

 

No group selected

100%

 

Caucasian

Caucasian

100%

 

Afro-American

Oriental

100%

 

Mexican-American

Hong Kong Chinese

100%

 

Others

Japanese

89%

 

 

Polynesian

90%

 

 

North Indian

90%

 

 

South Indian

87%

 

 

Pakistani

90%

 

                                                   

 Of African descent
  87%


 Aborigine
  85%


In the case of ATS/ERS standards: depending on the ethnic group set, the correction percentage acts on the predicted values of the following parameters:

FVC, FEV1, FEV3, FEV6, FIVC, FIV1, EVC, IC, VC, ERV, TV, TV/ti

In the case of NHANES III standards: depending on the ethnic group set, different predicted formulae are taken into account (in accordance with the reference standard).
Once the desired ethnic group has been selected, the device completes defining the patient parameters and returns automatically to the main screen.
In the case of GLI for every Ethnic group the device applies a different table to calculate the predicted values and not a correction percentage.

Setting the Personal Best value for the patient the physician can define the predicted values for FVC, FEV1 and PEF parameters. The following screen will be enabled, where it will be possible to set which parameter manage with Personal Best and the value.

When Personal Best are enabled the print reports show a dedicated area describing which parameters are enabled.


Editing Patient Data


Select the icon and use the screen as described above
 WARNING

Selecting this function does not create a new patient as described beforehand, but changes the data of the same patient and associates future test data with that patient, who is always identified with the same unique ID code.

 WARNING

The physician can modify the “Personal Best” management enabling or disabling the “Personal Best”. The new settings will be applied only to the new session. Data in archive are not modified.


VIEWING STORED DATA

HOW TO SEARCH THE ARCHIVES


In the main screen, you can access the data present in the device archive by using the above icon.

You can choose to search by:
  1. ID
  2. Surname
  3. Date of birth
  4. Test date
  5. All

 

Or select the type of test:

  1. FVC
  2. POST
  3. VC
  4. MVV
  5. OXY

Each option selected will bring up a box in which you can enter the search data.

VIEWING ARCHIVED DATA

The archive displays the list of patients, starting with the most recent.

Select the patient required by tapping the line (which becomes orange) and choose one of the enabled functions listed at the bottom of the screen.

The enabled icons are coloured, while the grey ones are disabled. To quit the archive, use the icon .

To view the spirometry tests performed by the selected patient, use the icon .

The information is displayed as in the image on the right. On the left you have the test trend in graph form (Flow/Volume and Volume/Time), while on the right you have various quality-related messages and the values of the parameters selected in the service menu.

If FVC, FEV1 or PEF are highlighted in red in the results area this means that they are set in with “Personal best” predicted values. The Personal Best setting can be found on the header row next to patient data (“PB” after patient gender).

By swiping your finger in the parameter area, you can view other

parameters selected in the service menu.

 

You can delete one of the tests performed as follows: tap the column relating to the test data to be deleted; the data will be selected by two bands on the left and right; now tap the icon  on the lower right. And tap “OK” in the popup window which appears on the screen.

At each screen, you can go back to the previous step by tapping 

To view the selected patient's oximetry tests, use the icon   .

The data is displayed as in the image to the right, with the graphic trend of the % SpO2 and BPM always on the left and the numerical values of the various parameters on the right.

You may cancel the test by using the icon  on the lower right.

If you want to perform a new test on the selected patient from this screen, you can use the icon for the test to be performed; a message is displayed to confirm whether or not you wish to perform a new test on the selected patient. Tap "YES" to confirm or "NO" to go back.

If the patient has performed several spirometry or oximetry tests, the initial list indicates (in brackets next to the type of test) the number of tests saved.
To view tests other than the first, tap the icons  (for spirometry) or  (for oxymetry).

DISPLAYING THE LAST TEST SESSION

During test sessions, the spirometer automatically saves up to 8 FVC tests. From the main screen, using the icon:
 in the case of spirometry tests
 in the case of oximetry tests
You can view the best three session tests (where PRE1 is the best). At the end of the session, when you enter a new subject or switch to a POST phase, the 3 best tests of the previous session are automatically saved in the archive. These, therefore, can be retrieved from the archive and printed, either together or individually.

Numbers may appear on the main screen, next to the spirometry test icons, for example:

The number inside the red circle represents, in this case, the FVC tests performed in the current session.

ONLINE MODE (CONNECTED TO A PC)

This function acts like an actual laboratory-based real time spirometer connected to a PC.
Connection to the PC can be performed by USB or by a wireless Bluetooth connection. Spirolab becomes an intelligent sensor for measuring volume and flow rate while the PC controls the functions, including turning on and off.
In addition to the usual spirometric parameters and F/V curves in real time, this system can also gather more sophisticated information such as ventilatory profiles and extrapolated volume (Vext) data.
The computer software allows the use of more up-dated bronchial provocation protocols and can display FEV1 dose and time- responses.
 WARNING

When the device is connected to a PC, it cannot be directly operated. The settings on the PC are transferred to the device and remain active any other time you use the device directly. For example, if you use spirolab connected to the PC and you set a particular turbine (disposable or reusable), this will remain the default turbine any other time you use the device remotely, until the device is restarted. It is important, therefore, to be careful when setting the type of turbine.

PERFORMING A SPIROMETRY TEST

 WARNING

While performing tests, unplug the charger from spirolab.


To correctly perform a spirometry test, observe the following instructions to the letter.

  1. Slide the turbine fully into position in the MiniFlowmeter then turn it clockwise until it clicks into place.
  1. Connect the MiniFlowmeter to spirolab as show in the image on the right.
  1. Slide the mouthpiece at least 0.5 cm along the groove on the turbine.
  2. Fit the nose clamp over the patient's nostrils to prevent air from escaping.
  3. Take the MiniFlowmeter with both hands or, alternatively, hold it as you would a mobile phone.
  1. Introduce the mouthpiece into the mouth behind the teeth, making sure that air does not escape from the sides of the mouth

 WARNING

The proper positioning of the mouthpiece behind the teeth is essential to eliminate any turbulence that might have a negative effect on the test parameters.

 WARNING

We recommend that the patient stays upright during the test and bends forward during exhalation to allow the abdominal muscles to facilitate the expulsion of air.

The main screen contains the following icons to perform various types of tests:
  FVC Spirometry test
 VC spirometry test
 MVV spirometry test
 Test with bronchodilator (POST)
To end a test, tap 

FVC TEST


To perform an FVC test, follow the instructions below:
  1. INHALE all the air
  2. EXHALE forcefully (>6s)
  3. INHALE forcefully
The test can be started (optionally) by breathing at rest. When you are ready, inhale as quickly as possible (it is easier if you open your arms wide) and expel all the air in your lungs with as much force as you can. Without removing the mouthpiece, complete the cycle by inhaling as quickly as possible. The latter step can be omitted if calculation of the inhalation parameters (FIVC, FIV1, FIV1%, PIF) is not required.
The inhalation stage can also be performed before putting the mouthpiece in your mouth.
Following a slow deep intake of breath, the next exhalation should be performed with as much force as possible and as quickly as possible. After 6 seconds of exhalation, the device will emit a continuous beep that tells you that the minimum exhalation time has passed. This is the minimum time required by the main International Pulmonology Associations.
 WARNING

Remember that for accurate spirometry results, it is essential that all the air is expelled from the lungs.

The test can be repeated as often as required without the mouthpiece having to be removed from the mouth. In this case, the spirolab will automatically recognise the longer cycle (longer FVC+FEV1) and present the relative readings.
On completion of the test, tap .
During the test, the spirolab emits repeated beeps, the frequency of which is directly proportional to the speed at which air is being inhaled and exhaled. This helps the doctor understand when the rate of air flow is approaching zero and therefore when the patient has exhausted the volume available in exhalation and inhalation.
The section dedicated to maintenance also describes how this feature is also useful for easily checking that the volume and air flow sensors are working properly.
Apart from requiring a deep exhalation of breath for the results of an FVC test to be reliable, the Forced Expiratory Time (FET) must also be long enough to allow the complete expulsion of all the air in the lungs.

VC TEST


Ventilatory profile
You can start testing Slow Vital Capacity by breathing at rest. After three or four similar consecutive breaths, a continuous beep warns the user that the ventilatory profile has been measured and that VC or IVC can now be measured.
Slow Expiratory Vital Capacity: VC
After the beep, inhale as slowly as possible and subsequently exhale as slowly as possible.
Slow Inhalatory Vital Capacity: IVC
After the beep, exhale as slowly as possible and subsequently inhale as slowly as possible.
On completion of the test, tap .

MVV TEST


Start the test with a series of forced inhalations and exhalations at the fastest speed possible. The recommended frequency is 30 breaths/minute.
The test ends automatically after 12 seconds
 WARNING

To test the service menu test, check that the parameter relating to said test is enabled in "Set parameters"; otherwise, the icon will be disabled.

 WARNING

It is important to remember to change the disposable mouthpiece and the disposable turbine at the end of a patient's test session.

RUNNING POST TESTS AFTER THE ADMINSTRATION OF A DRUG

 WARNING

To perform a POST test, the patient must have performed at least one PRE FVC test on the same day (i.e. in the same session); you cannot perform POST tests on PRE VC or MVV tests; conversely, you can perform POST VC or MVV tests, provided at least one PRE FVC test has been performed and archived on the same day.



To perform a POST test, proceed as follows:

Tap  on the main screen.

The screen on the right shows the list of all the patients who have performed a PRE test on the same day.

Select the patient required and choose one of the features enabled below.

The user is prompted to confirm the move to POST mode: tap "YES" to carry out the test in POST mode, or tap "NO" to go back. By "POST" test, we mean a spirometry test performed after administering the patient a bronchodilator. The tests subsequently performed on the selected patient show the following parameters:
  1. ​The values for the test performed;
  2. The values of the best PRE test performed by the same patient on the same day (i.e. in the same session);
  3. The percentage change between PRE and POST values (in the column labelled CHG).

You cannot perform a POST test on a patient if the archive only contains PRE tests carried out on previous days (sessions other than the current one).
If, during a POST session, you create a new patient or retrieve another patient from the archive, the device automatically exits the current POST session.

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