Btl-08 Spiro: User'S Manual

BTL-08 SPIRO
USER’S MANUAL
101RS2012/11/11EN
BEFORE YOU START
Dear Customer,
Thank you for purchasing BTL technology. All of us at

BTL wish you every success with your system. We pride
ourselves on being as responsive as possible to our
customers’ needs. Your suggestions and comments are
always welcome since we believe an ongoing
relationship with our customers is critically important to
our future product line.
While we would like you to start using your new

equipment right away, we encourage a thorough reading
of this manual in order to fully understand the
operational features of the system.
Please visit our corporate website at

http://www.btlnet.com for the latest information on BTL
products and services.
Again, thank you for being a BTL customer.
BTL Industries, Ltd.
BTL-08 SPIRO – USER’S MANUAL I PAGE 2 OF 55

TABLE OF CONTENTS
1 BASIC CHARACTERISTICS OF THE DEVICE............................................................................................4
1.1 BTL-08 SPIRO Device .............................................................................................................................5
1.2 Rear Panel of the BTL-08 ........................................................................................................................6
1.3 Pneumotachograph BTL-08 SPIRO.........................................................................................................6
1.4 Parts Description of the BTL-08 SPIRO Pneumotachograph ..................................................................7
2 SAFETY INSTRUCTIONS ............................................................................................................................8
2.1 Health Risks .......................................................................................................................................... 10
2.2 Contraindications ................................................................................................................................... 11
2.3 Conditions that Could Markedly Influence the Measured Results .......................................................... 11
3 MEASUREMENT METHOD ........................................................................................................................ 12
4 SET-UP AND START-UP ........................................................................................................................... 12
5 OPERATING INSTRUCTIONS ................................................................................................................... 14
5.1 Ensuring the Accuracy of the Pneumotachograph Measuring ............................................................... 14
5.1.1 Calibration ........................................................................................................................................ 14
5.1.2 Calibration Check ............................................................................................................................. 16
5.2 Description of Controls .......................................................................................................................... 18
5.2.1 Main Screen Description .................................................................................................................. 18
5.2.2 Main Menu Description .................................................................................................................... 19
5.2.3 Keyboard Functions Overview ......................................................................................................... 20
5.2.4 New Spirometric Examination Setting .............................................................................................. 21
5.3 Spirometric Examination ........................................................................................................................ 23
5.3.1 Spirometric Examination Recording Procedure ............................................................................... 23
5.3.2 Manoeuvre and Examination Evaluation .......................................................................................... 27
5.3.3 Examination with Medication Procedure .......................................................................................... 31
5.3.4 Report Printing ................................................................................................................................. 32
5.4 Storage Battery ...................................................................................................................................... 34
5.5 Lithium Battery ....................................................................................................................................... 35
5.6 Setting Options (Menu) .......................................................................................................................... 35
5.6.1 Record Database ............................................................................................................................. 35
5.6.2 Profile Set-up ................................................................................................................................... 35
5.6.3 Calibration ........................................................................................................................................ 36
5.6.4 Unit Set-up ....................................................................................................................................... 37
5.6.5 Select Patient ................................................................................................................................... 38
5.6.6 Select Physician ............................................................................................................................... 38
5.6.7 User Set-up ...................................................................................................................................... 38
6 LIST OF ACCESSORIES............................................................................................................................ 41
7 TECHNICAL SPECIFICATIONS................................................................................................................. 42
7.1 BTPS Conditions Correction .................................................................................................................. 44
7.1.1 ATP TO BTPS Recalculation ........................................................................................................... 45
7.2 Measurement Reliability and Interpretation ........................................................................................... 45
8 CLEANING AND MAINTENANCE ............................................................................................................. 46
8.1 Paper Sensor Cleaning.......................................................................................................................... 46
8.2 General Cleaning ................................................................................................................................... 47
8.3 Disinfection ............................................................................................................................................ 47
8.4 Sterilization ............................................................................................................................................ 48
9 SPIROMETRIC PARAMETERS LEGEND.................................................................................................. 49
9.1 Forced Spirometry (forced profile) ......................................................................................................... 49
9.2 Relaxed Spirometry (relaxed profile) ..................................................................................................... 51
9.3 Maximum Voluntary Ventilation (MVV profile) ....................................................................................... 52
9.4 Predictive Values ................................................................................................................................... 53
10 BIBLIOGRAPHY ......................................................................................................................................... 54
11 CONTACTS ................................................................................................................................................ 55
11.1 Manufacturer ......................................................................................................................................... 55
11.2 Sales and Service .................................................................................................................................. 55

1 BASIC CHARACTERISTICS OF THE DEVICE
The BTL-08 with pneumotachograph (BTL-08 SPIRO) is a pneumology diagnostic system designed for
performing both the basic and extended (such as bronchoprovocative) spirometric examinations. Spirometric
examination is a functional pulmonary examination to find the static and dynamic spirometric parameters and it is
one of the basic pneumology diagnostic techniques.
The BTL-08 with pneumotachograph (BTL-08 SPIRO) enables the users to perform quick and intuitive
recording of spirometric examinations, tabular and graphic representation of results (including their printing on the
integrated or external printer) as well as the selection of standards for the predictive values and user profiles
(including the protocol for bronchoprovocative tests).
To find the latest information on BTL products and to contact BTL companies, please visit our websites at:
http://www.btlnet.com.

1.1 BTL-08 SPIRO DEVICE
12
Fig. 1.1
For the description of individual keys, see Chapter 4.2.3.
1. Printer cover
2. Detent lever for the printer head
3. Colour touch-screen
4. Battery level indicator (batt)
5. Switch-on indicator (power)
6. Storage battery charging indicator (charge)
7. Discharged storage battery indicator (low batt)
8. Printer error indicator (printer)
9. Connector for patient ECG cable (It is possible to extend the spirometry functions with the ECG module)
10. Section of the keyboard to operate the printer
11. Section of the keyboard for setting the record characteristics
12. Power switch (on/off)

1.2 REAR PANEL OF THE BTL-08
Fig. 1.2
1. Power switch of the charging of the built-in battery: 0 and I Positions

2. Connector for the power cord connection
3. Communication connector RS 232 to connect pneumotachograph
4. Communication connector USB to connect personal computer (PC) or external printer
5. Line fuse
6. Manufacturing and type plate (Located on the bottom cover of the device)
7. Mains voltage switch
8. RESET button: Programme restart (In the event of device not responding to the pressing of any keys)
9. Clamp for device shielding (Located on the bottom cover of the device and only with the ECG module
mounted)
1.3 PNEUMOTACHOGRAPH BTL-08 SPIRO
Fig. 1.3
1. Pneumotachograph BTL-08 Spiro

2. Pneumotachograph stand

1.4 PARTS DESCRIPTION OF THE BTL-08 SPIRO PNEUMOTACHOGRAPH
4
1
5
Fig. 1.4
1. Pneumotachograph body
2. Button to release spirometric sensor
3. Silicone seal
4. Plastic sterilizable spirometric sensor (with a metal measuring mesh inside)
5. Disposable antibacterial filter
6. Paper mouthpiece
7. Plastic sterilizable mouthpiece
8. Communication cable

2 SAFETY INSTRUCTIONS
CAUTION!
All of our devices are equipped with a protective system to prevent the connection and use of equipment other
than that which is supplied by BTL. Consequently, BTL devices will not operate with equipment from other
manufacturers. The BTL-08 Spiro has applied parts of the BF Type.
This device does not use any pharmaceuticals or chemical agents that are applied by the device or any of its
integral parts.
This connector relates only to the combined BTL-08 ECG + Spiro unit. You will find its purpose in the User’s
Manual for the BTL-08 ECG MT Plus and Lx.
This marked clamp is connected to the framework of the device. It relates only to the combined BTL-08 ECG +
Spiro unit. You will find its purpose in the User’s Manual for the BTL-08 ECG MT Plus and Lx.
Read the service instructions carefully before the first activation of the device.
Safety Precautions
• No modification of this equipment is allowed.

• All personnel using the device, must have the required service qualification in the health service. They must
especially know the contraindications of an examination with the device and all potential danger including the
effective procedures to prevent infection transmission.
• All personnel using this device must be knowledgeable in the servicing technique, maintenance and
verification of the device as well as about the principles of safely working with the device.
• Electrical power mains connected to the device must be done according to the existing valid local standards
and codes (CSN 33 2140 and IEC 364) and they must be certificated according to these standards. If you are
not absolutely sure that the power mains supply is in perfect order, have a technical revision carried out by an
engineering inspector.
• Check whether the parameters of the power mains supply correspond with the requirements of the device
according to the Technical Specifications chapter. Additionally, verify that the mains voltage switch, which
is located on the rear panel of the device, is switched to the correct voltage according to the parameters of
the power mains it is connected to.
• The device is designed to work in an environment defined in the Technical Specifications chapter. It must
not be used in an environment with the threats of explosion hazard or water penetration. The device must not
be used in atmospheres with flammable anaesthetics or oxidative gases (O2, N2O, etc.).
• Place the device out of direct sunlight and out of the reach of strong electromagnetic fields in order to avoid
undesirable interactions. In case of undesirable interactions, move the device away from source of
disturbance or contact an authorised BTL service centre.
• Before every use, examine the device properly for loose cables, damaged cable insulation, functions of the
display, indicators, operating elements etc.. In case of any discrepancy, stop using the device and contact an
authorised BTL service centre. If the behaviour of the device shows any divergence from the normal
functioning procedure as described in this User’s Manual, stop using the device and contact an authorised
BTL service centre.

• If the device shows any signs of defects or you are in doubt about its correct operation, stop working with the
device immediately. Do not turn the device on if its case is defected. If you cannot detect the source of your
concerns, even after a careful reading through of the User’s Manual, contact a BTL authorised service
department without delay. If the device is used contrary to this instruction manual or it is used in despite of
the device showing functional divergences from those stated in this User’s Manual, then the user is
responsible for any damage caused by or caused to the device!
• Do not attempt to disassemble the device for any reason. Dismantling and unlocking the safety cover carries
the danger of electric shock. The eventual replacement of the lithium battery and lead-acid storage battery
must be carried out by an authorized BTL service centre technician.
• All materials and parts that come into direct contact with the patient's body (including the detergents used for
cleaning the electrodes, mouthpieces, etc.) must meet the appropriate standards regarding relevant to
irritation, allergisation, toxicity, genotoxicity, carcinogenity in accordance with the standards ISO 10993-1, ISO
10993-3 and ISO 10993-5. The operator is responsible for all materials and parts that were not supplied by a
BTL device distributor.
• Do not use the connectors designed for the accessories, as well as the other connectors, for connecting
anything other than the equipment intended by the service instructions. This carries a serious risk of electric
shock and serious damage of the device!
• The device is not radioactive nor does it use any toxic materials during its operation, storage and transport
under the given conditions.
• When transferring the device from a cold environment into a warm one, wait until the temperatures equalize
(1 hour minimum) before plugging it into power mains.
• When switching the device off and back on again; you must wait at least 3 seconds.
• The device does not carry any risk to patients with cardiac pacemakers.
• When disposing of the device after years of its service, it is necessary to remove the lithium battery and the
lead-acid storage battery. Dispose of them in a proper way, DO NOT put the batteries into municipal waste.
After battery removal, the device can be disposed of in the way common for this type of device. This device
does not contain any toxic materials that could damage the environment when disposed of in the correct way.
• If it is necessary to discard the device, the lithium battery must be removed. The removed battery must be
disposed according to local hazardous waste disposal requirements. Do not place the device in municipal
waste containers. The device itself does not contain any toxic materials which could harm the environment.
Warning: Removal of the batteries causes non-reversible damage to the device. Do this only during the
environmental-friendly disposal of the device!
Procedure:
a. Unscrew the lower cover of the device
b. Use suitable tools to remove the batteries. See the picture below for the position of the
batteries
BTL-08 SPIRO:
Fig. 2.1
• Do not use the device and accessories in any way other than those shown in this User’s Manual.
• Use the recommended protective equipment when working with this device.
• This device must be kept out of the reach of children.
• This device does not contain any user-repairable components. Do not remove any covers from the device.
ALL repairs must always be performed by a BTL authorised service centre technician.

2.1 HEALTH RISKS
During the spirometric examination and especially after its completion, it is necessary to follow the basic hygienic
regulations in order to reduce the risk of possible infection. The BTL-08 SPIRO Pneumotachograph is designed
to enable every user to select the level and the method of protection, according to their needs, by selecting the
filter and/or mouthpiece from the following options:
• Disposable Antibacterial Filter: This is the safest to use, because all possible bacteria and
viruses get caught in the antibacterial filter that is used by only one patient and then disposed of according
to the regulations valid for biological waste. All the other parts of the pneumotachograph remain clean all
the time. This filter also guarantees the most exact measurement, because the mesh of the spirometric
sensor will not get contaminated.
• Disposable Paper Mouthpiece: Using the paper mouthpiece lowers the risk of infection
transmission by direct contact. The paper mouthpiece must be used by one patient only and then be
properly disposed of as biological waste. The spirometric sensor, silicone sealing and surface of the
pneumotachograph body should be replaced, disinfected or sterilized after each use because they could
have been contaminated with the patient's breath or contact (See the instructions in Chapter 7: Cleaning
and Maintenance). The responsibility for making the decision about the most suitable way to prohibit the
infection transmission lies with the medical personnel.
• Sterilizable Plastic Mouthpiece: The plastic mouthpiece, spirometric sensor, silicone sealing and
surface of the pneumotachograph body should be replaced, disinfected or sterilized after each use
because they could have been contaminated with the patient's breath or contact (See the instructions in
Chapter 7: Cleaning and Maintenance). The responsibility for making the decision about the most suitable
way to prohibit the infection transmission lies with the medical personnel.
If there is any doubt about the possibility of infection or transmission of TBC, HIV, Chlamydia pneumonia,
hepatitis or other highly contagious diseases, we implicitly recommend the use of our Disposable Antibacterial
Filter.
Potential infection transmission routes are:
Direct Contact: Possible risk of contamination from upper-airway diseases, intestinal infections and blood-
transmitted infections (including hepatitis and HIV).
Direct-contact infection transmission is possible through a re-used disposable antibacterial filter, a used
pneumotachograph mouthpiece, spirometric sensor or pneumotachograph body. These parts may be
contaminated not only with saliva, but also with blood from open ulcers, cuts or scratches in the mouth and
bleeding gums or from contact with the patient’s hands.
Indirect Contact: Potential risk of contamination with tuberculosis, viral infections etc.
Indirect-contact infection transmission is possible through all parts of the pneumotachograph which come to
contact with the patient’s breath, if a disposable antibacterial filter is not used. If a disposable antibacterial filter is
used, the potential source of infection is minimized.
The most contaminated device parts are the disposable bacteriological filter, the mouthpiece and the spirometric
sensor (if a disposable antibacterial filter is not used).

2.2 CONTRAINDICATIONS
The following list of contraindications show the conditions when the manufacturer does not recommend applying
the spirometry measuring because of a health risk [2]. The final liability for the evaluation of each patient’s specific
state of health and the safety of the application rests upon the physician and respective medical personal that
specifies the indication and performs the examination.
ABSOLUTE
• Postoperative conditions after chest operation
• First month after myocardial infarction
• Serious instability of air passages: Emphysema
• Bronchial non-specifically marked hypersensitiveness
• Serious difficulties during gas exchange: Total or partial respiratory insufficiency
RELATIVE
• Spontaneous condition after pneumothorax
• Arterial- venous aneurysm
• Severe arterial hypertension
•
rd
Pregnancy with complications in the 3 month for the test of the MVV profile: Hyperventilation syndrome
2.3 CONDITIONS THAT COULD MARKEDLY INFLUENCE THE MEASURED RESULTS

• Strong, unpleasant pulmonary pain or stomach-ache
• Strong, unpleasant pain in mouth or face
• Stress incontinence
• Dementia or confused state
• Smoking one hour or less before the examination
• Alcohol consumption four hours or less before the examination
• Intensive exercise / movement activity 30 minutes or less before the examination
• Overeating or the consumption of a big meal two hours or less before the examination
• Tight-fitting clothing that can restrict the maximum breath

3 MEASUREMENT METHOD
The BTL-08 Spiro pneumotachograph uses the so called Lilly method for flow and volume measurements. Lilly
method means that the pneumotachograph measures the difference in pressure over before and after a
membrane with known resistance. As a result, the volume and flow are measured and are considered as the input
values. The output comes on the screen in form of calculated spirometric parameters (see chapter 10).
4 SET-UP AND START-UP
Unpack the device from the packaging and place it on a firm, flat surface which is sturdy enough to support the
weight of the device. We recommend that you keep the device packaging for possible further transport of the
device.
Do not expose the device to the direct rays of the sun. The device heats up during operation and therefore it must
not be placed near equipment that can heat up or generate heat. You must not place any objects on the device
which produce heat. Do not place containers of water, or any other liquid, on the device.
Do not place the device near any equipment which produces strong electromagnetic, electric or magnetic fields
(such as diathermy, X –rays, etc.). These fields could affect the operation of the device.
Additionally, the recording paper is heat-sensitive and should be placed out of the reach of thermal radiators. Do
not store the thermal paper in direct sunlight. See the Storing Conditions of Thermal-sensitive Paper chapter
for more information. In case of any doubt, contact an authorised BTL equipment service centre.
The BTL-08 SPIRO device is cooled by natural and forced air circulation. The cooling vents are located on the
bottom side of the device and around the printer. These vents must not be covered. Do not put the device on a
soft surface as this could block or limit the air circulation to through bottom cooling vents.
Plug the device directly into the power mains supply.
Do not use an extension cord with multiple connections or an adaptor.
Connect the patient part of spirometry (the pneumotachograph with spirometric sensor and mouthpiece) to the
RS232 connector on the rear panel of the device (No. 3, Fig. 1.2).

Fig. 4.1
Switching-on the device:
Plug the power cord into its socket and switch the toggle switch (No. 1, Fig. 1.2) marked O/ I to the I position and
then press the on/off switch on the keyboard (No. 12, Fig. 1.1). The switch-on indicator (No. 5, Fig. 1.1) will light
up.
Leave the charging power switch of the device (No. 1, Fig. 1.2) in the I (on) position, so the battery can charge.
Storage battery charging:
The device contains an internal storage battery which is supplied in a semi-charged state. After the device is
purchased, we advise you to format the storage battery by plugging the device into the power mains supply with
the toggle switch (No. 1 Fig. 1.2) left the I position for at least 48 continuous hours. The device will be charged up
and the storage battery will be correctly formatted and charged to the maximum level. A correctly formatted
storage battery allows for a longer operation of the device on one charge. For further information, see the
Storage Battery section.
Reset of the device:
If for any reason (such as electromagnetic interference, etc.) the device stops responding to the user's commands
(via the keyboard or touch panel) and there is no “Wait Please” message with the little moving squares, then it is
possible to put the device back into its initial state by pressing the reset button (No. 8, Fig. 1.2) on the rear panel
of the device. After this action, the device will restart immediately. After the start-up of the device, it should be
possible to continue working with the device.
Device memory:
The data stored in the device is saved, even in the event of accidental switch-off and/or disconnection of the
power supply.

5 OPERATING INSTRUCTIONS
The BTL-08 Spiro can be completely controlled by means of the touch-screen. Additionally, it is possible to use
the built-in keyboard, which includes the keys for frequently used commands. After the start-up of the device, the
main examination screen will appear.
Fig. 5.1
Before the first use of the pneumotachograph and after every replacement, cleaning or sterilization of the sensor,
it is necessary to perform a calibration of the device or to check of the calibration in order to ensure the required
measuring accuracy (See the Calibration chapter). Next, it is necessary to select an existing patient file (or create
a new one) and then to create a new examination.
5.1 ENSURING THE ACCURACY OF THE PNEUMOTACHOGRAPH MEASURING

The accuracy of the air flow through the BTL-08 SPIRO Pneumotachograph is the basic precondition for reliable
and correct results of your spirometric examinations. The BTL-08 SPIRO has two mechanisms for the ensuring of
the maximum measuring accuracy possible: Calibration and calibration check.
5.1.1 CALIBRATION
Calibration is the process which enables the fine setting of the correction parameters for the specific combination
of the pneumotachograph, spirometric sensor and filter/mouthpiece, so that the system achieves the best possible
accuracy during the measuring. Calibration is performed by means of a special calibration syringe. So as to
achieve the best results, we recommend using the calibration syringe with a volume of 3 litres supplied by BTL
(see Chapter 5).

Calibration procedure
1. Connect the pneumotachograph to the BTL-08 SPIRO unit and switch it on.
2. Firmly connect the pneumotachograph to the output of the calibration syringe and make sure that the
connection is tight.
3. Press the calib button on the main screen to start the Calibration Wizard.
4. Before the start of calibration check, modify the calibration settings if necessary
(Menu→Calibration→Calibration set-up)
calibration setup
syringe
volume
calibration records calibration check
Fig. 5.2
In particular, check the set calibration volume and make sure that it corresponds to the actual volume of the
calibration syringe. Additionally, you can modify the total number of manoeuvres during the performance of the
calibration or the calibration check. In both cases, it is possible to select the number of calibration manoeuvres for
each flow (slow, medium or fast). We also recommend performing three manoeuvres for each flow during the
calibration and one manoeuvre during the calibration check (See below).
Press the back button to get back to the calibration screen, where you can use the calibration records button
to open the screen for the administration of calibrations.
Note: You can also get to the calibrations administration screen by using the calib button on the main screen or
by using the calibr key.

5. To start calibration, press the “calibrate” button. Empty the calibration syringe by depressing the piston to
stop and press the “start” button to the start the calibration. Then watch the animation on the screen and move
the piston of the syringe according to the instructions, always to the extreme stop position. Depending on your
settings, several slow, medium and fast manoeuvres are performed. Move the piston at the same speed as you
see in the animation.
Move the piston as shown on the

screen.
Fig. 5.3
6. After the completion of the last manoeuvre, the screen will show the table containing data for each calibration
manoeuvre and the resulting calibration coefficients for the inspiration and expiration parts.
5.1.2 CALIBRATION CHECK

During the use of the pneumotachograph, various changes of the properties may occur (clogging of the sensor
mesh, water condensing, mechanical damage, etc.) and this may influence the accuracy of measuring. The
calibration check procedure verifies whether the existing configuration of the pneumotachograph and its setting
(calibration) still correspond to the required accuracy. If they do not, then it is necessary to perform new
calibration procedure.
After each replacement of the sensor or its disassembly, sterilization and re-assembly; it is necessary to perform
a calibration.

Calibration check procedure
1. Calibration check can be performed for any saved calibration that you will select from the list of calibration
records. However, usually the last calibration for the particular pneumotachograph is used and checked and
then it is automatically preselected in the table.
2. To start the calibration, press the “calibration check” button on the calibration records screen.
Fig. 5.4
3. The process of calibration check is the same as for calibration; just follow the instructions on the screen.
4. After the completion of the last manoeuvre, the screen will show the table containing the checked results for
each calibration manoeuvre and the total deviation found.

5.2 DESCRIPTION OF CONTROLS
5.2.1 MAIN SCREEN DESCRIPTION
child incentive
animation
flow-volume graph
predicted values
–volume-time graph
volba profilu kalibrace vstup do

hlavního menu
zavedení papíru spuštení náběru jméno pacienta

manévru
Fig. 5.5
Paper insertion:
Depending on the paper type, it moves either to the next page (with Z-fold paper) or by approximately 3 cm (with
roll paper). The button may be pressed several times. For more information about the paper handling, see the
Printer and Paper chapter.
Profile selection:
Selection of the profile in which you want to perform the examination. The profile includes:
- Manoeuvre type: FVC, SVC or MVV
- Standard for the calculation of predicted values
- Spirometric parameters to be displayed in the results (maximum of 15 parameters)
- Interpretation
- Setting of bronchomotor tests
- Printer settings
Start of Recording
After pressing the start button, the device starts recording the air flow and displays the signal on the graphs. At
the same time, the displayed start button is replaced by the stop button until the termination of the manoeuvre.
Calibration:
To open the screen for the administration of calibrations such as the selection, editing, performance or calibration
checks.

Patient name:
The name of the selected patient. The patient is selected in the Menu→Select patient screen.
Menu:
To enter the main menu of the device.
Child incentive:
To display or hide the incentive picture for children.
5.2.2 MAIN MENU DESCRIPTION
Fig. 5.6
Description of the main menu buttons:
Record Database: List of individual measured records; they can be edited, printed or exported
Profile Set-up: Setting, creation and deletion of individual profiles for examination
Calibration: Calibration of the pneumotachograph
Unit settings: Open the device settings
Select Patient: Selection, creation or deletion of patient file
Select Physician: Selection of the attending physician
ECG: Switches to the ECG mode (only in the combined BTL-08 SPIRO+ECG unit)
Back: Return to the main screen window

5.2.3 KEYBOARD FUNCTIONS OVERVIEW
Fig. 5.7
The keys of the keyboard facilitate the frequently performed tasks during an examination recording and thus, do
not need to be entered on the touch-screen. Every keyboard key, except on/off, has its equivalent on the touch-
screen.
Start
This key starts the data recording for particular measurements. It is always necessary to enter all the important
information about the patient before the initiation of the recording (See Menu-Patient selection); otherwise it will
not be possible to calculate the predicted values.
Accept
Pressing the accept button confirms the acceptance of the recorded manoeuvre and that it has been saved. If the
manoeuvre is unsatisfactory, press the start key again to record a new manoeuvre.
Stop
This button interrupts the running of a manoeuvre or printing. If the device is busy, such as with an analysis or the
measuring of spirometric curve, the reaction of pressing the stop key may be delayed.
Print
Pressing this key prints the report of the completed examination or a record selected from the database.
If the device is busy, such as with an analysis or the measuring of spirometric curve, the reaction of pressing the
print key may be delayed. In such case, wait until the device finishes the running the operation (meaning the
display stops displaying the “working...” message) and press the key again.
Analyse
Press this button to display the result of the analysis of the last recording. Also, it is used to abort the examination
of the patient. By pressing this button, the examination recording will finish and it is not possible to continue in
performing additional manoeuvre.
Forced
Press the forced key to select the forced profile (FVC).
Relaxed
Press the relaxed key to select the relaxed profile (SVC).
Mvv
Press the mvv key to select the MVV profile (MVV).
Profile
Selection of one of the user profiles. The selection cyclically rotates through all of the user-defined profiles. The
name of the currently selected profile is always displayed on the Profile button, which serves as the selection of
the profile from the touch-screen.
Patient
Press this key to activate the dialog window for the entering of a new patient’s data. To save the data, press
enter. This data is printed in the record and also saved in the device’s memory together with the recording. It can
be selected from the patients’ card and you can view them or possibly print them out on recording paper. The
types of data to be filled out and saved can be selected in menu → device set-up → patient’s record set-up.

Calibr
Press the calibr key to enter the database of calibration records. Further selection in the calibration records
submenu can be controlled by means of the touch-screen. In the database, it is possible to perform sensor
calibration or to perform a calibration check. For the detailed description of all calibration functions, please see
Chapter 4.1.
Child incentive
This key switches the children incentive pictures on and off during an examination in the forced profile. The
chosen picture appears in the right-half of the display.
Predict values
Single-use (for one examination) change of the standard for the calculation of predicted values. Normally, the
standard for predicted values is a part of the profile. The selection remains valid only if you start the examination
immediately afterward, so it is necessary to select the patient before using this option.
Contrast
This key allows for the quick set-up of the display contrast. The contrast can also be changed in the device set-up
menu.
A change of contrast of the colour display may modify the colour rendition of the current colour scheme.
Menu
Press this key to enter the main menu of the device.
Up/down arrows
These keys are used for the moving within the menu and to change the possible values.
Esc
Press this key to cancel the selection or to return to the higher dialog window in the menu without saving the
entered values.
Enter
Press this key to confirm the selection and save the values.
on/off
This key is used to switch the device on and off. If the device is connected to the mains and the toggle mains
switch on the rear panel is in the “I” position, the device monitors the state of the storage batteries at switching off
and if it finds the batteries to be discharged, it will switch itself into the charging mode. This will be indicated by
the power and charge indicators being on. After the storage battery has been recharged, the device will
automatically switch off completely and the indicators will go out. If the device is not connected to the mains or the
switch is in the “O” position, the device always switches off completely and the storage battery is not charged.
Note: It may take some time to recognize the condition of the storage battery; therefore the device may respond
with a certain delay when switched off and immediately switched on again.
Note: If the device does not respond to any keys or buttons (including on/off) and no time-consuming operation is
running (such as print, export, etc.), reset the device by means of pressing the reset key (No. 8, Fig. 1.2), For
more information, see Chapter 3.
5.2.4 NEW SPIROMETRIC EXAMINATION SETTING

1. Select a patient (on the main menu, press the select patient button) or create a new one (press the new
button to create the patient) or edit an old one (press the edit button to edit the patient’s information).
2. Fill in the patient data and check the validity of the existing data, especially the height, weight, age and race
of the patient. These are very important for the correct evaluation of the examination and they cannot be
changed later for the specific examination!

3. To confirm the patient selection, press the OK button or the Enter key.
Fig. 5.8
4. Depending on the type of the examination performed, modify the existing profile or create a new one by
selecting profile set-up in the main menu. To create a new profile, press the new profile button and to
change the profile, press the configure button.
profile selection
new profile delete profile
configure selected
profile
Fig. 5.9

5. If you want to perform forced expiratory spirometry only, it is important to set the spirometry mode item to
expiratory.
6. After pressing the back button on the main menu window, the main screen for the spirometric examination
recording appears. Here you can select the required profile by pressing the profile button and confirm it by
pressing OK.
7. Now you can start the examination by pressing the start button. After the analysis, the examination will be
automatically saved.
5.3 SPIROMETRIC EXAMINATION

When switched on, the device starts up in the preset default profile. The default profile can be set in menu –
profile set-up. The forced profile is preset as the default setting by the manufacturer. Therefore, the display will
show the main screen containing the graph of full expiratory and inspiratory loop (Flow [F] / Volume [V]) and the
graph of expiratory curve (Volume [V] / Time [t]). The device is now ready for direct data recording.
5.3.1 SPIROMETRIC EXAMINATION RECORDING PROCEDURE

1. Check the connection of the pneumotachograph to the unit. See the Set-up and Start-up chapter for more
information.
2. Select the patient.
3. Select the profile for the examination by pressing of the profile button. For details on the profile set-up, see
Chapter 4.2.4. The BTL-08 Spiro has he following three (3) predefined basic profiles for various types of
spirometric examinations:
- forced : FVC – Measuring of spirometric parameters at the maximum expiration and inspiration
effort
- relaxed:SVC – Measuring of spirometric parameters at normal effort
- mvv: MVV – Measuring of the maximum voluntary ventilation
Besides these three profiles, it is possible to create and set also additional user profiles (see Chapter 4.2.4).
4. Prepare the patient for the examination:
a. Make sure that the patient has taken off any tight clothing which could obstruct the correct
performance of the manoeuvre. Consider contraindications and other possible risks (See Chapter 2:
Safety Instructions).
b. Ask the patient to put on the nose clip and to test the tightness of the seal by asking the patient to
expire through the nose.
c. Check the cleanness of the spiro sensor and the measuring mesh.
d. Instruct the patient about the required way of breathing during the manoeuvre depending on the
selected examination type:
FVC:
Deep and fast maximum inspiration immediately followed by a maximum forced and deep
expiration which should last at least 6 seconds (for children under 10 years at least 3 seconds)
and followed by a maximum fast and forced inspiration. Then the patient may take the spirometric

sensor out of his/her mouth and breathe normally.
Flow [l/s]
Expiration
End Start
Volume
[l]
Inspiration 1 Inspiration 2
Fig. 5.10
If only the expiration part of forced spirometry is performed, only the main expiration is
done into the pneumotachograph, the other parts of the manoeuvre are performed off the
spirometer.
SVC:
Several cycles of relaxed breathing (as needed, but at least two (2) cycles), followed by a
maximum deep expiration and then a maximum inspiration ending with another maximum
expiration and then relaxed breathing. Then the patient may take the spirometric sensor out of
his/her mouth and breathe normally.

Objem [l]
Max.
inspiration Max.
Tidal breathing expiration
End
Start
Max.
expiration
Time [s]
Fig. 5.11
MVV:
First, six (6) seconds of relaxed breathing (indicated by the first vertical line in the graph), followed
by maximum forced breathing for 15 seconds with such frequency and depth that will maximize
the volume of air exchanged between the patient and the atmosphere. The ideal breathing
frequency is 90 to 110 breaths per minute. Then the patient may take the spirometric sensor out
of his/her mouth and breathe normally.
Tidal breathing Max.

ventilation
Start End
Fig. 5.12
5. Hand the pneumotachograph to the patient and put the filter and the mouthpiece on the sensor or let the
patient handle the sterile filter and the mouthpiece themselves.
6. Press the start key to start the manoeuvre recording.

7. Ask the patient to put the mouthpiece in their mouth, bite it lightly with their teeth and make a seal firmly with
their lips around it, so that the connection is tight. During the examination the patient should be sitting upright
to avoid compressing his/her chest. The patient’s head should remain erect and they should lean slightly
forward, so that the windpipe is not constricted. The pneumotachograph should be held in a horizontal
position during the examination to prevent the clogging of the mesh or the sensor with the patient’s saliva.
Fig. 5.13
8. Ask the patient to perform the manoeuvre according to your instructions. During the examination, give the
patient encouragement and support him/her to achieve the maximum values. Use phrases like “still longer”
or “still deeper”.
9. The manoeuvre is terminated by pressing the stop key or automatically.
10. If you are satisfied with the accomplished manoeuvre, press the accept key to accept the manoeuvre.
Otherwise, press the start key again to start a new manoeuvre over without saving the existing one.
11. The device enables to record and save three (3) manoeuvres. After the acceptance of the third manoeuvre,
the device automatically analyzes the manoeuvres and chooses the “best” one and displays it in the table.
For the forced profile, it is possible to change the choice of which “best” manoeuvre to use by selecting on
the touch-screen. The criteria for the automatic selection are as follows:
a. Forced: The highest sum of the FVC and FEV1 parameters

b. Relaxed: The highest SVC parameter
c. MVV: The highest MVV parameter
The analysis can be started by pressing the analyse key after any manoeuvre; however, this will end that
particular examination because after the analysis it is no longer possible to record additional manoeuvre for
the examination. The following screen enables the operator to print out the final report on the internal or an
external printer.

measured
parameter name prediction percentage from prediction
values
best manouevre
manouevres
Repeatability
(+ parameter repeatable, - parameter not
repeatable)
Fig. 5.14
12. Pressing the results key will display the table with the results of the entire examination and the comparison
to the predictive values. To return to the previous screen with the table of all manoeuvres, press the back
key.
Fig. 5.15
5.3.2 MANOEUVRE AND EXAMINATION EVALUATION

The responsibility for the correct evaluation of the manoeuvres’ quality and interpretation of the examination
always lies with the doctor. There are many standardized criteria [2] and recommendations for the evaluation of
the manoeuvre and examination quality, as well as for the interpretation of the examination results. The BTL-08
SPIRO provides the doctor with decision support in the form of the automatic evaluation of these criteria and
interpretation.

Acceptability
The evaluation according to the “acceptability” criteria according to [2] is contained in the final printed report. The
following three (3) criteria are evaluated:
- EV: The size of the reversely extrapolated volume has to be less than the greater of the values
of 150ml and 5% of FVC.
- TEX: The time which the patient tries to breathe out has to be longer than:
a) Six (6) seconds for patients over 10 years of age
b) Three (3) seconds for patients up to 10 years of age
- Plateau: During the expiration, a flow of less than 25ml/s has to be achieved for at least one
second
Repeatability
The evaluation of the repeatability criteria according to [2] is displayed both in the final printed report and on the
screen with the results of the entire examination, as well as in the status bar located just above the bottom
toolbar. These criteria are as follows:
- FVC: The FVC parameter of two manoeuvres of the given stage with the highest FVC values
must not differ by more than:
a) 150ml for the total FVC value > 1l
b) 100ml for the total FVC value ≤ 1l
- FEV1: The FEV1 parameter of two manoeuvres of the given stage with the highest FEV1
values must not differ by more than:
a) 150ml for the total FEV1 value > 1l
b) 100ml for the total FEV1 value ≤ 1l
- ACC3 : The given stage contains at least three (3) “acceptable” manoeuvres
Verbal evaluation of manoeuvres
The status bar located just above the bottom toolbar displays the following list of messages:
- “Start faster” – If the reversely extrapolated volume exceeds the greater of the values 150ml
and 5% FVC
- “Breathe out stronger” – If the PEF has not reached at least 90% of the maximum in the given
stage
- “Breathe out longer” – If an expiration of at least 6 seconds long has not been detected (at least
3 seconds for patients under 10 years)
- “Breathe out deeper” – If the plateau at the end of the expiration has not been detected
- “Deeper inspiration” – If the FVC is more than 5% less than the best FVC
- “Faster expiration” – If the FEV1 is more than 5% less than the best FEV1
- “Test successful” – The test was successful
- “Breath pattern not found” – The breath pattern required for the given manoeuvre type has not
been detected

Automatic interpretation of results
The final printed report includes the automatic interpretation of results according to the algorithm of the selected
author. It can be chosen from: Enright, ATS or BTS. The way in which each algorithm works is indicated in the
following diagrams. The selection of interpretation according to individual authors is a part of the profile set-up.
Fig. 5.16
Fig. 5.17

Fig. 5.18
Additional criteria for the evaluation of the manoeuvre quality
Besides the acceptability and repeatability, it is also necessary to monitor whether or not the manoeuvre includes
the following artefacts during the examination. These artefacts can adversely affect the recording quality and
applicability of the results:
o Cough
o Closure of the vocal cords in the first seconds of expiration
o Early interruption of expiration
o Different intensity (consecutive measurements should not dramatically vary)
o Leakage of air around the mouthpiece or through the nose
o Blocked mouthpiece (such as by the patient’s tongue)
o Obstacle of the air flow to the pneumotachograph (such as by the patient’s tongue, teeth, lips or
dentures)

5.3.3 EXAMINATION WITH MEDICATION PROCEDURE
If you want to perform the examination with the use of medication, you must define the profile with medication
protocol first. We recommend creating a new forced type profile for this purpose (See Chapter 4.2.4). The new
profile should be set for it the medication protocol for bronchoconstriction and bronchodilatation according to the
following procedure:
Creation of the medication protocol
1. Open the setting of the selected forced type profile ( menu→profile →set-up by using the arrow keys
to select the required profile→edit )
Fig. 5.19
2. Press the bronchoconstrictor test button to open the screen for the bronchoconstriction medication
protocol set-up. Enter the name of the bronchoconstriction substance and the dosage then press the
protocol button to continue to the screen for the dosage protocol setting. Fill in individual doses for the
protocol and confirm.
Fig. 5.20
3. In the same way, but by filling in only one dose, you can also set the bronchodilatation medication
protocol.

Bronchomotor examination recording
1. Select the profile with the required protocol for bronchomotor examination.
2. Record the PRE stage in the standard way (See Chapter 4.3.1).
3. On the results screen, press the bronchoprovoc.post button
4. Press the new manoeuvre → start button to record the manoeuvre. After being accepted, the
manoeuvre is added to the table together with the respective medication dose according to the set
protocol. This way, you will record all manoeuvres of bronchoprovocation. The device will end the
recording of provocation manoeuvres when the medication protocol is completed or when the
termination criterion occurs which happens when FEV1 parameter drops by at least 20%.
5. Press the back button to return to the examination results screen. Next, press the bronchodilat.post
button to start the bronchodilatation stages according to the set protocol.
6. Perform the recording of the manoeuvre by pressing the measuring→ start button. In the
bronchodilatation stage, you may record up to three (3) manoeuvres.
5.3.4 REPORT PRINTING

The final report may be printed either from the screen with the analysis of all manoeuvres immediately after the
completion of examination recording (See Chapter 4.3.1) or directly from the database of records.
For the printed copy of the report, it is possible to use either the integrated thermal printer or an external USB
printer. Contact your supplier of BTL devices for a current list of the supported printers.
The selection of the printer (integrated or external USB) for the examination report printing is a part of the profile
settings (menu→profile set-up→edit→print settings→printer type).
Integrated printer and paper
The integrated printer uses thermo-sensitive paper. The paper quality can significantly influence the quality of
printed report. For a high-quality printout, we advise to only use paper recommended and/or supplied by BTL.
The yellow indicator (No. 8, Fig. 1.1) displays an error condition which has occurred with the printer. This can be
caused by:
• Running out of paper

• Faulty pressure of the printer head on the paper. The detent lever of the printer head (No. 2, Fig. 1.1) is
in the unlocked position. By turning the detent lever to the left, the head will lock and be ready for
printing.
• Improperly closed printer cover, the use of unsuitable paper type or the setting the printer for an
inadequate paper type.
An error message with additional information is displayed on the screen together with the indicator.
Paper sensitivity
Every paper type has a slightly different sensitivity to the thermal impulses produced by the printer. The final print
can be too light and illegible or too dark and almost burnt (displayed as a white centre inside the printed line).
For these reasons, the device is adaptable to different paper types. The paper sensitivity can be set in the menu
– device set-up - paper and print set-up in the paper sensitivity item. The more sensitive the setting, the
lighter the print will be. There are five (5) sensitivity settings. When changing the paper type, it is best to try the
suitable settings for a couple of prints.

Roll paper with raster
The device can print on thermo-sensitive roll paper with the raster of a nominal width of 112mm (see Technical
Specifications chapter). For a high-quality record, we recommend only using paper supplied by BTL companies.
Paper insertion: Remove the printer cover (No. 1, Fig. 1.1), move the detent lever (No. 2, Fig. 1.1) to the right and
insert the paper into the paper container. Place it on the surface in front of the printer roller. Insert the end of the
recording paper under the guide roller. The printer mechanism will start to draw the paper in automatically. Close
the paper container cover and return the detent lever to the left position. Automatic feeding in of the paper may be
hindered, rendered askew or produce unevenly torn ends of the inserted paper if the detent lever position is
incorrect. It must be all the way on the right to prevent this.
ATTENTION: It is absolutely essential to insert new paper very carefully and exactly parallel with the tear-
off edge (the raster on the paper must be exactly in parallel with the tear-off edge). Otherwise, the paper
will slip to one side or the other as it unrolls and could become wrinkled or torn and possibly jam the
printer.
Note: The paper insertion and form feed (FF) button is also available on the on-line screen in the bottom left
corner after touching anywhere on the display. This button enables the operator to pull the paper out of the device
at any time.
Paper tearing: We recommend tearing the report from the roll paper by pulling it from the bottom edge of the
paper across the tear-off edge and towards the display.
Paper storage conditions: The device prints on thermo-sensitive paper. To achieve the longest time stability of the
printed record possible, it is absolutely necessary to keep the following conditions for storing new and printed-on
paper:
• Storage temperature (25°C or less)

• Relative humidity (6% or less)
• Do not expose the paper to the sunlight.
• Do not expose the paper to long-term radiation of fluorescent sources (such as fluorescent lights and
tubes).
• Do not allow the paper to come into contact with alcohol, esters or ketenes-based glues. Only used
starch, PVA or CMC-based dispersive glues.
• Do not allow the paper to come into with the PVC packing material. This packing contains materials with
an esters base that can damage the thermo-sensitive layer of the paper and cause the disappearance of
the record.
External USB printer
An additional printing possibility, besides the integrated thermal printer, is to connect the device to an external
printer via the USB interface. The USB connector is located on the rear panel (No. 4, Fig. 1.2) and is designed for
the connection to both the computer and the printer.
The external printer set-up screen ( menu → device set-up → paper and print set-up → usb printer set-up)
includes the following items:
- resolution (dpi): The print resolution of the printer connected via USB. We recommend using
200 dpi for faster printing. The 300 dpi resolution is intended for better quality printing. Print a
test page to find the suitable resolution for your printer.
- printer test: The button to print out the test page on the printer connected via USB to check
the connection and settings of the printer. The test page contains the dimensions for the
determination of the correct resolution, the resolution used, the description of the USB printer
and the description of the device. Compare the actual dimensions of the print area with the
dimensions stated on the test page to see if the proper resolution has been selected.

- Printer: Information about the printer connected to the device (manufacturer, supported
languages, available memory, and maximum supported resolution). In some cases, if an
unsupported printer or non-printer equipment is connected to the device, this information may
be illegible.
The recommended maximum length of the USB cable is 1.5 metres.
Printer requirements:
• Interface USB1.1 or USB2.0

• Language PCL5
• Compatible with HP DeskJet or LaserJet
ATTENTION
Some printers that are not fully compatible with the USB standard may not be recognized by the device
and may cause slow data transmission through the USB. This current version does not support the HP LJ
1022 printer model.
For the most current information about compatible printers, contact your BTL device supplier.
5.4 STORAGE BATTERY

The type of the storage battery is mentioned in the Technical Specifications chapter. Replacement of the
battery is performed by BTL-authorised customer service centre.
The storage battery is continuously recharged during the operation of the device from the power mains. Charging
and maintenance of the battery in fully-charged condition continues when the device is switched off but it is still
connected to the power mains and the power switch (No. 1, Fig. 1.2) on the rear panel in the “I” position. When
switching off, the device checks the charging status of the storage batteries. If device determines during the
switching off procedure that the battery is discharged, it switches into the charging mode. During the charging
mode, the display is off and the power and charge indicators are on (See the section on Keyboard and the Top
Panel of the Device). After the storage battery has been recharged, the device will automatically switch itself off.
This applies only if the device is plugged in the power mains and the toggle switch (No. 1, Fig. 1.2) on the rear
panel is in the “I” position.
Note: It may take some time for the device to recognize the status of its storage battery; therefore the device may
respond with a certain delay when switched off and immediately switched back on again.
The storage battery is completely recharged after approximately 6 hours of charging (preferably overnight).
The discharged storage battery is indicated by two signalling levels.
• The storage battery is almost discharged, but it can still print for a short time: The low batt indicator (No. 7,
Fig. 1.1) will flash.
• The storage battery is discharged and the device has disabled the printer: The low batt indicator (No. 7, Fig.
1.1) stays lit and at the same time the device emits a warning signal (a short intermittent beep about once
every 20 seconds). The audible alarm can be turned off (See Chapter 4.6.7).
If the storage battery discharge status is indicated, it is possible that the device will not be able to print the whole
spirometric record. Printing interruption may occur during the recording. Nevertheless, the data is saved in the
device’s memory and it can be printed after the storage battery has recharged.
To extend the effective life of the storage battery, we recommend keeping it permanently fully-charged. When
possible, connect the spirometer to the power mains and turn the power switch (No. 1, Fig. 1.2) to the “I” position.
The indicator (No. 6, Fig. 1.1) will light up (and then will go out when it is fully recharged) and the storage battery
will be automatically kept in fully-charged condition.

If the device is disconnected from the power mains for a longer time, the storage batteries gradually and
spontaneously discharge even if the device is disconnected. This effect is a characteristic of the applied storage
battery and cannot be changed. Therefore, if the device has been switched off and disconnected for more than
about 2 to 3 months, we recommend fully recharging it, preferably for a continuous 48 hours.
For the same reason, we recommend charging the device continuously for at least 48 hours immediately after
purchase regardless of the storage battery level indicator. You can use the device as normal, just do not unplug
the device from the power mains. The storage battery is being recharged even during standard operation of the
device. The storage battery will format itself and it will last longer in operation after each recharging.
5.5 LITHIUM BATTERY

The device contains a lithium battery for the date and time back-up. The type of the battery is mentioned in
Chapter 6. Replacement of the battery is performed by an BTL-authorised customer service centre.
5.6 SETTING OPTIONS (MENU)

The main menu can be entered from the mode of monitoring of respiratory curves by pressing the menu key. You
can also enter the menu by using the touch-screen. To enter the main menu of the device, press the touch-screen
button with the menu sign (on bottom right of the display). There you can choose from the following options:
• Record database (data management)
• Profile set-up
• Calibration
• Unit set-up
• Select patient
• Select physician
5.6.1 RECORD DATABASE

This menu enables to recall, view and print the last performed recordings. The recordings are stored in the device
memory automatically. If the memory is full, the newly performed recording will overwrite the oldest record stored
in the memory. The records marked as archive (the mark button is the + sign is displayed in front of the record)
and they stay in the memory of the device permanently and are not overwritten (this means they must be deleted
manually).
You can do the following operations with the selected record:
• Print it repeatedly with the set-up with which it was recorded

• View the record on the display
• Mark or unmark the record as archive
• Delete the selected record or all of the records
• Display the records in optional order according to the attributes: Archive, date, name, or personal
identification number
Note: The records are saved in the memory of the device in a compressed form in order to save as many records
in the device as possible. Therefore, during the first entry into the archive, the device has to convert the records
into a readable form. This operation may take several seconds, depending on the number of saved records.
5.6.2 PROFILE SET-UP

The profiles are used for the quick set-up of the device and its immediate preparation for printing. The profiles are
the preset parameters of the recording and printing configurations. The parameters of the basic profiles are preset
by the manufacturer. The profiles can be set in the device menu before each examination, but not during
measuring.
The device has three (3) basic profiles:

• Forced Profile (forced button) is used for the examination of forced spirometry (FVC)
• Relaxed Profile (relaxed button) is used for relaxed spirometry (SVC)
• MVV Profile (mvv button) is used for maximal voluntary ventilation (MVV)
Besides these three, it is also possible to create additional profiles (via cyclic selection by pressing the profile
button), to modify existing ones or to deleted profiles (except the basic profiles which cannot be deleted)
4.1.1.1 Setting of the properties of the forced, relaxed and MVV profiles
For each profile, you can preset some of the following parameters according to the profile type:
• Name of the profile (Can be changed only for user profiles)

• Type of the profile (Can be changed only for user profiles)
• Predictive values (According to experimentally gained and evaluated measurements, for description see
Chapter 9.4)
• Spirometry parameters according to the type of the profile
• Automatic printing (Select on / off for automatic printing after the end of measuring)
• Print set-up
o Data printed in the record header: Setting the printing header
o Interpretation in header: Print or no print
o Spirometry graphs: Print or no print
o Printer type: Internal or external USB
• Automatic stop: Set whether the test is or is not automatically finished after the set examination time
• Interpretation: Either Enright, BTS or ATS
• Bronchodilatation test
o Name of the bronchodilatation substance
o Type of dosage (in ug or mg/ml)
o Quantity
• Bronchoconstriction test
o Name of the bronchoconstriction substance
o Type of dosage (in ug or mg/ml)
o Protocol
• Spirometry mode
o Inspiratory and expiratory forced spirometry: Complete
o Forced expiratory spirometry: Expiratory
5.6.3 CALIBRATION
When selecting calibration, the following buttons are displayed:
• Syringe volume set-up: Setting the capacity of the calibration syringe (3 litre capacity syringe supplied
by BTL)
• Calibration records: Record database of performed calibrations
• Calibration set-up: Setting the total number of manoeuvres performed at the calibration and calibration
check
Calibration Records
Here it is possible to select, enter, edit and delete the records of respective spirometric sensors. For this purpose,
we recommend marking the spirometric sensors with a number. This menu can be also entered from the on-line
mode by pressing the calibr key or by pressing the calib button on the touch screen.
Another function on this submenu is the calibration of the selected sensor by pressing the calibrate button.
After selecting a specific spirometric sensor, it is possible to perform a check of the accomplished calibration by
pressing the calibration check button on the bottom part of the display.
For details about the performance of calibration and calibration check, see Chapter 4.1.
Calibration Set-up
Here you can enter the total number of manoeuvres for performing calibration or calibration check. In both cases
it is possible to select at least three but no more than nine manoeuvres.
We recommend performing nine calibration manoeuvres for the calibration and three manoeuvres for the
calibration check.

5.6.4 UNIT SET-UP
On this submenu, you can choose from the following items:
• Choose the profile, in which the device will start after switching on (profile selection after the start)
• Set the track intensity of the spiro signal during printing (line width)
• Preset the information displayed on the patient's medical record (patient's record set-up)
• Set the optional specifications of the patient (patient's optional specifications)
• Preset printing parameters and the type of the paper to be used (paper and printing set-up)
• Information on the module
• Enter the next user set-up menu of the device (user set-up)
Starting Profile
Here you can choose the profile which will be preset on the device immediately after activating it using the on /off
key.
Line Width
Here you can set the track intensity for printing the spirometric curve. The set-up needs to be adjusted according
to the paper used. The setting only influences the printing of the actual spirometric curve and not the printing of
the other information (such as texts or pictures). Optimal printing can be achieved through this set-up together
with setting the suitable paper sensitivity (See above).
Patient Card Set-up

Activated items will appear when entering the patient's data and can be filled in. They are saved together with the
patient’s data.
You can activate the following items on the patient's medical record:
• Name
• Surname
• Name 2
• Identification number: Personal identification number
• Date of birth
• Sex
• Weight
• Blood pressure
• Height
• Cardiac pacemaker
• Race
• Smoker
• Two (2) other user-defined items: Their meaning & description can be set in Optional
Specifications of the Patient.
Optional Patient Data

Here you can define the names of the two optional items in the patient's record, for example diagnosis, general
health, etc...
Setting of paper and print

Here you can find important parameters relevant to printing. You can set the resolution of the USB printer, paper
sensitivity and paper insertion during the replacement.
The paper sensitivity set-up is important for optimal printing and together with the track width set-up, it most
influences the quality of printing. For more about printing, see Chapter 4.3.4.
Module Information
This part clearly displays all the crucial information about the configuration of the connected module. It shows the
serial number of the module, module type, firmware version, etc.. You will need this information in case of any
communication with the business or service department.
User Set-up
An additional wide range of various settings. For a detailed description, see Chapter 5.6.7.

5.6.5 SELECT PATIENT
The device contains a database of patients. It is possible to enter, edit and delete the patients. A new patient can
be also entered in the on-line mode by pressing the patient key. The entered values for the patient can be
adjusted in the device set-up,. See the Medical Record of the Patient: Patient Record Setting chapter. The
number of patients is limited only by the capacity of the device’s memory.
The patient's specifications are printed out in the header of the record according to the set-up of the relevant
profile.
The saved patients remain in the memory even when the device is switched off. When the device is first switched
on, no patient is selected.
5.6.6 SELECT PHYSICIAN

The device includes a database of physicians which is used for setting, editing or deleting of the entered
physicians. The number of physicians is limited only by the capacity of the device’s memory.
The data about the physician are printed in the footer of the record according to the set-up of the relevant profile.
The saved physicians remain in the memory even when the device is switched off. The function of the actual pre-
set physician is always left blank when the device is switched on.
5.6.7 USER SET-UP

Date and Time
Setting of the date and time of the device. The date and time are saved together with the records and are printed
out on the records. The preset date and time of the device are stored in its memory and are saved even when
storage batteries are discharged and the device is disconnected from the power mains.
Display Contrast
Here it is possible to adjust the required contrast of the display. The function is the same as when pressing the
contrast button on the on-line screen. The contrast is set by pressing the arrow keys on the touch-screen or on
the keyboard.
Note: The adjustment of the contrast on the colour display may change the colour presentation of the current
colour scheme.
Select Language
The setting of the language which the device uses to communicate with you. The modification will appear only
when the device is switched on again.
Touch Panel Calibration

If the display buttons do not correctly respond to the pressing of the touch-screen, the touch-panel needs
calibrating. The process of calibration is shown on the screen. During calibration, use the touch-pen (stylus) and
follow the on-screen instructions.
The calibration, if not successful, can be interrupted at any time by pressing the esc key.
To verify the touch-screen calibration, use the “touch-panel function test” function.
The touch-screen calibration can be started directly from the keyboard after opening the correct menu and then
pressing the start key.

Repair of Files
If saved data get damaged because of interference or a device fault, the device may show errors in the file
system (such as loss of some records or loss of some saved patients). This function initializes the file system
diagnostics and tries to fix the errors, without the loss of saved data, if possible. Depending on the amount of the
saved data, the function may last a considerably long (for several hours), so we recommend running this function
overnight. Once started, it is necessary to wait until the function is completed or you must perform a reset of the
device. See the Keyboard Functions Overview chapter.
File System Formatting

This function re-initializes the whole file system. It deletes all data saved in the device and puts the device into
the initialized state (meaning the default state of the device as when it was purchased). This function is used only
during a major accident or if the user wants to re-initialize the device completely.
Default Setting - No Data Loss

This function sets the device into the default state as when it was purchased (resets the language, colour
scheme, etc.) but it keeps the saved data of the profiles, patients, physicians and records.
Sleep Mode Interval

Here you can set the period of inactivity after which the device will switch itself off.
Battery Status Indication

Here you can switch the audio alarm indicating a discharged battery (a short and fast series of beeps) on and off.
The visual indication cannot be switched off.
More…
Pressing this button opens another screen with additional user setting items:
Unit Information
All crucial information of the device configuration is clearly displayed here. This includes the serial number, the
firmware version, the warranty limit, the printing module firmware version, the hardware key configuration and the
operating temperatures of each part of the device. This information is needed when communicating with our
business or service department.
Setting of HW Key
The configuration of the device can be remote-controlled. For the actual hardware configuration, see the Device
Information menu.
Password Setting
To prevent any unauthorized operation of the device, you can activate the prompt for requiring the entering of a
password when switching the device on. It is possible to turn on and turn off the password request or to change
the password. The password is a numeric combination of any length. If you forget the password, you can always
enter the default password (00000000).
Sound of Keyboard
To switch on/off the key sound.
Delete Patient after the Recording

Yes / no option to cancel the entered patient’s data immediately after the recording.
Save Current Physician

Yes / no option to save the name of the current physician.

More...
Pressing this button opens another screen with additional user setting items:
Hospital name
Possibility to enter the name of the hospital which will be printed on the final report.
Start Unit Mode

Selection of the mode in which the device starts after the switch-on. Only applicable on the combined BTL-08
SPIRO+ECG device.
Colour Schemes
Setting the colour rendition of the display. There are a number of colour schemes preset by the manufacturer that
you can edit or delete. Or you can create your own colour schemes. Every displayed item can be assigned its
own colour.
Colour of Curves
Selection of the colour foreground and background of the graph and its active and inactive curves.
Default Race of Patient

The patient’s race that will be automatically preset when creating a new patient without the necessity to select it
each time.

6 LIST OF ACCESSORIES
This device is not intended for use in connection with other equipment or other medical appliances and
instruments other than those mentioned in this manual.
This list includes the specifications of all equipment that are or can be supplied with the device.
More detailed information on particular equipment can be found in the enclosed leaflet.
Standard BTL Accessories:
• 4x spirometric sensor, plastic mouthpiece and silicone sealing sets

• 1x nose clip for BTL-08 Spiro
• 1x CD with the instructions for use
Additional Standard BTL Accessories for BTL-08 Spiro Pro:
• 1x ECG paper 25 m roll/112mm width

• 1x stylus for the touch-screen
• 1x power cord
• 1x dust cover for the device
• 1x spare fuse
Additional Standard BTL Accessories for Spiro and Spiro Pro Modules:
• 1x SPIRO case
Optional BTL Accessories:
• 1x spirometric sensor, plastic mouthpiece and silicone sealing set

• 1x calibration syringe for BTL-08 Spiro (Capacity 3 litres)
• 1x disposable paper mouthpiece*
• 1x antibacterial filter for BTL-08 Spiro
• 1x cart for BTL-08 Spiro Pro Plus
• 1x cart for BTL-08 ECG Mx, Sx & Spiro
• 1x cart for BTL-08 ECG Lx & Spiro
*A disposable paper mouthpiece can be also bought in specialized shops. The specific parameters for the
compatibility with the BTL spirometer are as follows: Mouthpiece length 71 mm, inner diameter 30 mm and outer
diameter 33 mm.
Standard accessories can be bought in addition.

7 TECHNICAL SPECIFICATIONS
Type: BTL-08 Spiro BTL-08 Spiro Pro
Display: touch screen
dimensions (mm) 120 x 89
screen resolution 640 x 480 RGB (colour)
Keyboard: combined – functional + touch screen buttons
Discharged battery indication: acoustic + light
Printer:
paper width (mm) 112 / A4 through USB
paper type roll / A4 – office paper
printer resolution 200 dpi in Y-axis, 500 dpi in X-axis / 300 dpi
print type thermal, external through USB
Measurement parameters:
BTPS correction automatic
inspire / expire yes / yes
FVC, Best FVC, FEV0.75, FEV1,

Best FEV1, FEV3, FEV6, PEF,
FVC, Best FVC, FEV1, FEV0.75/FVC, FEV1/FVC, FEV3/FVC,
Best FEV1, FEV6, PEF, FEV6/FVC PIF, FIVC, FIV1, MEF75,
forced profile FEV1/FVC, FEV6/FVC, FIVC, MEF50, MEF25, FEF75, FEF50,
FIV1, PIF, MEF75, MEF50, FEF25, MMEF, FET25, FET50, MIF75,
MEF25, Lung age MIF50, MIF25, PEFT, FIF50,
FEF50/FIF50, FEV0.75/FEV6, FEV1/
FEV6, FIV1/FIVC, Lung age, EV
relaxed profile - SVC, ERV, IRV, TV, IC, IVC
mvv profile - MVV, MVVf, MVVt, MRf
PRE/POST bronchoprovocative
yes
test
ECCS/ERS 1993, ECCS 1983, NHANES III, Knudson 1983, Knudson

Predictive values 1976,
Roca 1986, CRAPO 1981, ITS, Perreira – Brazil, LAM, Gore – Australian,

Zapletal 1977
Stored records 50 250
User defined profiles unlimited unlimited
Interpretation Enright, ATS, BTS
Child incentive yes
Device weight (max.) in kg: 3,2
Weight of case incl. accessories

1,18
(max.) in kg:
Dimensions (in mm ): 330 x 270 x 74
Operating conditions:
ambient temperature + 10 °C to + 40 °C
recommended ambient
+ 17 °C to +28 °C (to avoid any provocative bronchial reaction)
temperature
relative humidity 25 % to 95 %
barometric pressure 700 hPa to 1100 hPa
position horizontal
operation type permanent
Transport and storage conditions:
temperature - 10 °C to + 55 °C
relative humidity 25 % to 85 %
barometric pressure 650 hPa to 1100 hPa
position any
storage life 1 year
transportation only in supplied wrapping,

other conditions
recharge storage batteries minimally once a year
Technical specifications:
flow range (l/s) 0.025 - 16 (inspire / expire)
accuracy (50 ml/s to 16 l/s) ± 5 % or 50 ml/s (greater value applies)
volume range (litres) 0 to 8 litres
accuracy (0,025 to 8l) ± 3 % or 50 ml (greater value applies)
flow resistance < 79 Pa / l/S
BTPS corrections:
temperature sensor + 10 °C to + 40 °C

accuracy ± 3 % for 25°C
barometric pressure sensor 700 hPa to 1200 hPa
accuracy ± 2 % in mentioned range
relative humidity sensor 0 to 100 % RH
accuracy ± 4 % for 25°C, 30 to 80 % RH
Device power supply:
power input 40 VA
~ 99 V to 126 in (115 V rated voltage), AC

mains voltage
~ 198 V to 252 V (230 V rated voltage), AC
frequency 50 Hz to 60 Hz
Classification:
protection class II with functional grounding (according to IEC 536, IEC 60601 - 1)
spirometry standard ATS/ERS 2005
T1A / 250V, tube safety fuse

external fuse
5 x 20 mm, according to IEC 127 - 2
power switch on the rear side of the device, position 0 and I
IP code IP20
applied part type BF according to IEC 601 - 1
Internal chemical supplies:
battery lithium battery CR2032
lead-acid storage battery 1x 12 V / 1.2 Ah, 48x97x52 mm, maintenance - free
Up to 30 prints
storage battery capacity
Monitoring without printing: up to 90 minutes
charging time Internal (Recharge time: ~ 4 to 6 hours)
PC connection: USB
7.1 BTPS CONDITIONS CORRECTION

The air passing through the pneumotachograph during inspiration is measured for the temperature, relative
humidity and pressure of the room where the measuring is performed. These conditions are referred to as ATP

(ambient temperature and pressure). In the lungs, the air warms to body temperature and is saturated with water
vapour (almost to 100 percent) which is the so-called BTPS conditions (Body Temperature and Pressure
Saturated (with water vapour)).
This effect will change the air volume of the lungs. Therefore, so that it is possible to compare the results gained
under various ambient conditions, the calculations of all spirometric parameters are only performed after the
recalculation of the measured flow rate to each patient’s BTPS conditions.
The BTL-08 Spiro Pneumotachograph contains all necessary sensors to measure the temperature of the ambient
air, the relative humidity and the barometric pressure and enable the device to perform the ATP correction to the
BTPS conditions automatically. The measuring of the pressure, temperature and humidity of the ambient air is
continuous and the inspiration BTPS correction corresponds to the current values at any given moment. The
expiration corrections are done according to the constant parameters of temperature and humidity (35°C at 95%
relative humidity) and current barometric pressure.
BTL-08 SPIRO measures the barometric pressure that is not recalculated to the sea level, so called "absolute” or
“local" barometric pressure. The value of this pressure is not the same as that of the barometric pressure
measured by a weather station and recalculated to sea level.
7.1.1 ATP TO BTPS RECALCULATION

The resultant values in spirometry are indicated in the values recalculated to BTPS.
VBTPS = VATP * (Tbody / Tamb) * { [ pamb – pH20(Tamb, Hamb) ] / [pamb – pH20(Tbody, Hbody) ] }
Where: VBTPS – Gas volume recalculated to BTPS conditions

VATP – Gas volume measured at ATP conditions
Tbody – Human body temperature in Kelvin (310°K)
Tamb – Ambient temperature in Kelvin
pamb – Atmospheric pressure at ATP conditions
pH20(Tamb, Hamb) – Water vapour pressure at ATP conditions
pH20(Tbody, Hbody) – Water vapour pressure at BTPS conditions (6.282Pa, for example 47 torr)
Hamb – Relative humidity
Hbody – Relative humidity in the lungs (100%)
7.2 MEASUREMENT RELIABILITY AND INTERPRETATION

We consider the parameters correct if they have been evaluated from correctly performed manoeuvres on a
properly calibrated device and under the conditions suitable for the patient. Therefore it is the operator's
responsibility to check the physical environmental conditions and the calibration validity also. The operator
decides which manoeuvre will be regarded as the “best”.
The program automatically evaluates the measure results on the basis of the patient’s data entered and the
selected predictive norm or reference point. It is most advisable to double-check the accuracy of the patient’s data
entered (age, sex, height, etc.). Even then, it is up to the operator’s and each physician’s discretion of how to use
the results of this automatic interpretation.
It is necessary to mention that the measuring mesh of the pneumotachograph has to be properly taken care of
and in particular it needs to be kept clean. If the mesh gets fouled or damaged, some or all the parameters may
be unreliable regardless of the calibration result.

8 CLEANING AND MAINTENANCE
The service inspection including measuring of all parameters of the device and possible recalibration must be
performed at intervals less than 30 months. The inspection and recalibration must be performed by an authorized
BTL service department on the basis of the user's order. If the inspection is not done within the stated term, the
manufacturer does not continue to guarantee the technical parameters or safe operation of the product.
Keep the device clean. Do not store or use it in extremely dusty environment for a long time and do not immerse
it in any liquid. Before each use, check to see if the device and its accessories (especially cables) are not
mechanically or otherwise damaged. Do not use the device if any part is damaged!
The manufacturer may offer on request the circuit diagrams, component part lists, descriptions, calibration
instructions that will assist service personnel
Fuse replacement
The fuse box is located on the rear panel in a black round box (No. 7, Fig. 1.2). Before replacement, make sure
that the power switch (No. 1, Fig. 1.2) is in the “0” position and then disconnect the power cord from the unit. Turn
the segment of the fuse box to the left using a flat-head screwdriver (or thin coin) in the slot and remove the fuse.
Insert a new fuse and turn the box back to the right. It is forbidden to insert a fuse with another rating other
than that stated on the fuse box..
This action should only be done by persons acquainted with this procedure!
Cleaning the surface of the device and its parts:
For cleaning of the device and its parts, use a soft cloth slightly moistened with water or 2% solution of detergent.
Do not use agents containing alcohol, ammonia, benzine, thinners, etc.
Also do not use abrasive materials to clean the surface of the device parts. Make sure that water and other
cleaning agents do not get inside the device.
Cleaning the touch-screen
The surface of the touch-screen can be cleaned by cleaning agents suitable for monitors or those used for
cleaning glass surfaces. These cleaning agents can be applied by a spray only. LIGHTLY spray the cleaning
agent on the centre of the touch-screen and then GENTLY wipe and polish the whole surface with a dry cloth.
Press the cloth VERY GENTLY; otherwise the touch-screen could crack.
ATTENTION
The cleaning agent must not get under the edges of the touch-screen, otherwise it could penetrate into the
device.
The cleaning agent should not come into contact with any other parts of the device except the touch-screen.
8.1 PAPER SENSOR CLEANING
Every six (6) months, wipe off dirt and dust from the paper sensors with a soft brush or dry cotton swab. The
sensors are located under the printer cover near the upper edge of the device (two black squares) and are
accessible when the printer cover is removed from the device.

Transport and Storage
We recommend keeping the original packaging of the device. For transport it is suitable to pack the device in this
original packing to ensure its maximum protection...
Handle the device with care and avoid big shocks. The device should be stored or transported only under the
conditions defined in the Technical Parameters chapter.
8.2 GENERAL CLEANING

We recommend cleaning the device after every patient with cleaning agents approved by competent authorities of
the particular country. You can use products like Sekusept, Bacilol, etc. For the cables of the accessories you can
use cleaners like Incidur spray and other similar products. DO NOT USE SOLVENTS!
8.3 DISINFECTION
CAUTION! The patient's parts and spirometric sensor may be contaminated with bacteria and viruses of the
patient. Therefore, it is necessary to disinfect those using cleaning agents and procedures intended and approved
for disinfecting.
Make sure to only use consistently disinfected mouthpieces, spirometric sensors and seals (See Chapter 2.1
Health Risks).
Applications suitable for disinfection solutions are product like Chiroseptol, Gigasept Instru AF or Sekusept Forte.
Disinfecting solutions:
1. Chiroseptol: A 2% solution with exposure time 30 minutes.

2. Gigasept Instru AF: A 2% solution with exposure time 30 minutes.
3. Gigasept Instru AF: A 3% solution with exposure time 15 minutes.
4. Sekusept Forte: A 3% solution with exposure time 30 minutes.
Working process:
1. Remove the part intended for cleaning and disinfection.

2. Clean the part under running water.
3. Disinfect the part by entirely immersing it into the disinfectant solution for the specified exposure time.
4. Rinse properly under cold running drinking water several times.
5. Let dry before use.
The lifetime of the replaceable mouthpiece, spirometric sensor, sealing and nose clip is about 160 disinfection
cycles.
Notice: For patients with TBC or HIV (or if there is a suspicion of these diseases), we recommend using the
disposable antibacterial filter consistently.
Warning: If you use disinfectants containing aldehydes, the disinfected parts of the spirometry equipment may
change in colour and become brown.

We do not recommend using disinfectants containing peracetic acid or substances generating peracetic acid in
the disinfecting solution. If you use these disinfectants, the spirometric sensor may get mechanically loosened
and damaged.
8.4 STERILIZATION
We advise to carry out sterilization according to standard recommendations for plastic objects without hollow
parts at a maximum temperature of 121 °C for sterilization time of 20 minutes.
After the sterilization of the spirometric sensor it is necessary to let the sensor cool down to a temperature lower
than 40 °C before using it next. Otherwise the sensor may get mechanically damaged!
The lifetime of the replaceable mouthpiece, spirometric sensor, sealing and nose clip is about 70 sterilization
cycles.

9 SPIROMETRIC PARAMETERS LEGEND
9.1 FORCED SPIROMETRY (FORCED PROFILE)

FVC = Forced Vital Capacity [l], the maximum air volume the patient is able to expire after the maximum
inspiration, when the expiration is performed with the maximum speed and effort
PEF = Peak Expiratory Flow [l/s], the maximum air flow achieved during forced expiration
FEV0.75* = Forced Expiratory Volume in 0.75s [l], volume exhaled during the first 0.75 of a second of forced
expiration*
FEV1* = Forced Expiratory Volume [l], volume exhaled during the first second of forced expiration - “one-second
vital capacity”
FEV3* = Forced Expiratory Volume [l], volume exhaled during the first three (3) seconds of forced expiration -
“three-second vital capacity”
FEV6* = Forced Expiratory Volume [l], volume exhaled during the first six (6) seconds of forced expiration - “six-
second vital capacity”
FEV0.75*/FVC = ratio [%] between the volume exhaled during the first 0.75 of a second of forced expiration and
the forced vital capacity
FEV1*/FVC = ratio [%] between the “one-second vital capacity” and the forced vital capacity
FEV3*/FVC = ratio [%] between the “three-second vital capacity” and the forced vital capacity
FEV6*/FVC = ratio [%] between the “six-second vital capacity” and the forced vital capacity
PIF = Peak Inspiratory Flow [l/s], the maximum air flow achieved during forced inspiration
FIVC = Forced Inspiratory Vital Capacity [l], the air volume which the patient is able to inhale after the preceding
maximum expiration with the inspiration being performed with the maximum speed and effort
FIV1* = Forced Inspiratory Volume [l], volume inhaled during the first second of forced inspiration - “one-second
inspiratory vital capacity”
MEF75 = Maximum Expiratory Flow at 75% of FVC to expire [l/s], the maximum air flow during forced expiration
at the moment when 75% of the air volume remains in the lungs
FEF75 = Forced Expiratory Flow at 75% of FVC expired [l/s], the maximum air flow during forced expiration at the
moment when 75% of the air volume has already been exhaled
MMEF (FEF25 – 75) = Maximal Mid-Expiratory Flow [l/s], the maximum mean expiration flow; the average flow in
the mid-point of forced expiration

FET25* = Forced Expiratory Time at 25% of FVC expired [s], time needed for the expiration of 25% of the FVC
value
FET50* = Forced Expiratory Time at 50% of FVC expired [s], time needed for the expiration of 50% of the FVC
value
MIF75 = Maximum Inspiratory Flow at 75% of FIVC to inspire [l/s], the maximum air flow during forced inspiration
at the moment when 75% of the air volume (FIVC) remains to be inhaled
MIF50 = Maximum Inspiratory Flow at 50% of FIVC to inspire [l/s], the maximum air flow during forced inspiration
at the moment when 50% of the air volume (FIVC) remains to be inhaled
MIF25 = Maximum Flow at 25% of FIVC to inspire [l/s], the maximum air flow during forced inspiration at the
moment when 25 % of the air volume (FIVC) remains to be inhaled
PEFT* = Peak Expiratory Flow Time (Rise Time) [in minutes], the time within which the flow increases from 10%
to 90% of the PEF flow value
FIF50 = Mean Forced Inspiratory Flow at 50% of FIVC inspired [l/s], the maximum air flow during forced
inspiration at the moment when 50% of the air volume have already been inhaled
FEF50/FIF50 = ratio [%] between the maximum air flow during forced expiration at the moment when 50% of the
air volume have already been exhaled and the maximum air flow during forced inspiration at the moment when
50% of the air volume have already been inhaled
FEV0.75*/FEV6* = ratio [%] of the volume exhaled during the first 0.75 second of forced expiration and the
volume exhaled during the first 6 seconds of forced expiration
FEV1*/FEV6* = ratio [%] between the volume exhaled during the first second of forced expiration and the volume
exhaled during the first 6 seconds of forced expiration
FIV1*/FIVC = ratio [%] between the volume inhaled during the first second of forced inspiration and the inspiratory
forced vital capacity
Lung age = age [in years], at which the actual value of FEV1 would equal to the predicted value, calculation
according to [6]
Aex = Area under Expiration [l^2/s], the area under the expiration curve of forced expiration
* All time-dependent parameters count the time (starting from time zero) determined by the back extrapolation of volume in
the place of the maximum air flow according to EN ISO26782, 3.18

Fig. 10.1
9.2 RELAXED SPIROMETRY (RELAXED PROFILE)

SVC (EVC) = Slow Vital Capacity [l], vital capacity of the lungs; the volume exhaled from the state of full inhalation
to the state of maximum exhalation performed in a relaxed manner
IVC = Inspiratory Vital Capacity [l]; the air volume inhaled from the state of full exhalation to the state of maximum
inhalation performed in a relaxed manner
ERV = Expiratory Reserve Volume [l]; the air volume exhaled from the state of relaxed exhalation to the state of
maximum exhalation performed in a relaxed manner
IRV = Inspiratory Reserve Volume [l]; the air volume inhaled from the state of relaxed inhalation to the state of
maximum inhalation performed in a relaxed manner
TV (Vt) = Tidal Volume [l]; the air volume exchanged between the lungs and the atmosphere by calm, non-forced
breathing performed in a relaxed manner
IC = Inspiratory Capacity [l]; the air volume inhaled from the state of relaxed exhalation to the state of maximum
inhalation performed in a relaxed manner

SVC
IRV
IC
TV
IVC
ERV
EC
Fig. 10.2
9.3 MAXIMUM VOLUNTARY VENTILATION (MVV PROFILE)

MVV = Maximum Voluntary Ventilation [l/min]; the maximum air volume which the subject is able to exchange
between the lungs and the atmosphere within a defined time (usually 12 seconds)
MVVf = Maximum Voluntary Ventilation frequency [breaths/minute], average breathing frequency during MVV
MVVt = Maximum Voluntary Ventilation time [s], time which the maximal ventilation lasts (usually 12 seconds)
MRf = Maximum Respiratory frequency [breaths/min], the maximum breathing frequency during the measuring of
MVV

9.4 PREDICTIVE VALUES
A summary of predictive values that are implemented by the BTL CardioPoint-Spiro software are shown in the
table below.
[15]
[5]
[7]
[13]
[10]
[9]
[11]
[6]
[14]
[12]
[17]

10 BIBLIOGRAPHY
[1] Fišerová J., Chlumský J., Satinská J. a kol.: Funkční vyšetření plic. GEUM, 2004.
[2] Standardization of Spirometry. ATS/ERS Task Force: Standardization of Function Testing. European
Respiratory Journal 2005; 26: 319-338
[3] American Thoracic Society. 1994 Standardization of Spirometry. 1994 Update. American Review of
Respiratory Disease. 152 : 1107-1136.
[4] The European Standard EN 13826 : 2003 Peak Expiratory Flow Meters. Czech Edition ČSN EN 13826 :
2003. Český Normalizační Institut, 2003.
[5] Standardized Lung Function Testing by European Community for Coal and Steel 1983.
[6] Hankinson John L., Odencrantz John R., Fedan Kathleen B. 1999. Spirometric Reference Values a Sample
of the General U.S. Population. American Journal of Respiratory And Critial. Care Medine. Vol. 159.
[7] Quanjer Ph. H., Tammeling G. J., Cotes J. E., Pedersen O. F., Peslin R., Yernault J-C. 1993. Lung Volumes
and Forced Ventilatory Flows. ERS Journals Ltd. 6, Suppl. 16, 5 – 40.
[8] Morris J. F., M.D., Temple W. 1985. Spirometric “Lung Age” Estimation for Motivating Smoking Cessation
[9] Knudson R. J., Slatin R. C., Lebowitz M. D., Burrows B. 1976. The Maximal Expiratory Flow-Volume Curve.
American Review of Respiratory Disease 113 : 587-600.
[10] Knudson R. J., Lebowitz M. D., Holberg Catharine J., Burrows B. 1983. Changes in the Normal Maximal
Expiratory Flow-Volume Curve with Growth and Aging. American Review of Respiratory Disease 127 : 725-
734
[11] Lam Kwok-Kwong, Pang Shing et al. A Survey of Ventilatory Capacity in Chinese Subjects in Hong Kong.
Annals of Human Biology, 1982, vol. 9, No. 5, 459-472.
[12] J. Roca, J. Sanchis, A. Agusti-Vidal, F. Segarra, D. Navajas, R. Rodriguez-Roisin, P. Casan, S. Sans.
Spirometric Reference Values from a Mediterranean Population. Bulletin European Pathophysiology of
Respiration, 1986, 22, 459-472.
[13] Gore C. J., Crockett A. J., Pederson D. G., Booth M. L., Bauman A., Owen N.: Spirometric Standards for
Healthy Adult Lifetime Nonsmokers in Australia. European Respiratory Journal, 1995, 8: 773-782.
[14] Carlos Alberto de Castro Pereira, Sueli da Penha Barreto, João Geraldo Simõnes, Francisco W.L. Pereira,
José Gerson Gerstler, Joge Nakatani. Valores de Referência para a Espirometria em uma Amostra da
Populacao Brasileira Adulta, Jornal de Pneumologia 18(1):10-22, Maco de 1992
[15] Crapo RO, Morris AH, Gardner RM. Reference Spirometric Values Using Techniques and Equipment that
Meets ATS Recommendations. American Review of Respiratory Disease, Volume 123, p.659-664, 1981.
[16] General Considerations for Lung Function Testing. ATS/ERS Task Force: Standardization of Function
Testing. European Respiratory Journal, 2005; 26: 153-161.
[17] A. Zapletal, T. Paul and M. Samanek, Significance of Contemporary Methods of Lung Function Testing for
the Detection of Airway Obstruction in Children and Adolescents, Z Erkr Atmungsorgane, Aug 1977, 149(3):
343-71

11 CONTACTS
11.1 MANUFACTURER
BTL Industries Ltd.
161 Cleveland Way
Stevenage
Hertfordshire
SG1 6BU
United Kingdom
Email: sales@btlnet.com
Website: http://www.btlnet.com
11.2 SALES AND SERVICE

E-mail: service@btlnet.com
Website: http://www.btlnet.com
th
Date of Last Revision: 11 of November, 2012
© All rights reserved. No part of this manual may be reproduced, saved in a research centre or transferred by any
means including electronic, mechanical, photographic or other records without previous approval from BTL
Industries Limited
BTL Industries Limited operates a policy of continuous development. Therefore, it reserves the right to make
changes and improvements to the product described in this manual without prior notice.
The contents of this document are provided "as is". Except as required by applicable law, no warranties of any
kind, either expressed or implied, are made in relation to the accuracy, reliability or contents of this document.
BTL Industries Limited reserves the right to revise this document or withdraw it at any time without prior notice.

Btl-08 Spiro: User'S Manual

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Btl-08 Spiro: User'S Manual

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BTL-08 SPIRO

Thank you for purchasing BTL technology. All of us at

While we would like you to start using your new

Please visit our corporate website at

Again, thank you for being a BTL customer.

BTL Industries, Ltd.

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For the description of individual keys, see Chapter 4.2.3.

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1. Power switch of the charging of the built-in battery: 0 and I Positions

1.3 PNEUMOTACHOGRAPH BTL-08 SPIRO

1. Pneumotachograph BTL-08 Spiro

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• No modification of this equipment is allowed.

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Potential infection transmission routes are:

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• Postoperative conditions after chest operation

• First month after myocardial infarction

• Serious instability of air passages: Emphysema

• Bronchial non-specifically marked hypersensitiveness

• Serious difficulties during gas exchange: Total or partial respiratory insufficiency

• Spontaneous condition after pneumothorax

• Arterial- venous aneurysm

• Severe arterial hypertension

2.3 CONDITIONS THAT COULD MARKEDLY INFLUENCE THE MEASURED RESULTS

• Strong, unpleasant pain in mouth or face

• Dementia or confused state

• Smoking one hour or less before the examination

• Alcohol consumption four hours or less before the examination

• Intensive exercise / movement activity 30 minutes or less before the examination

• Tight-fitting clothing that can restrict the maximum breath

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4 SET-UP AND START-UP

Plug the device directly into the power mains supply.

Do not use an extension cord with multiple connections or an adaptor.

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Switching-on the device:

Storage battery charging:

Reset of the device:

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5.1 ENSURING THE ACCURACY OF THE PNEUMOTACHOGRAPH MEASURING

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Move the piston as shown on the

5.1.2 CALIBRATION CHECK

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volba profilu kalibrace vstup do

zavedení papíru spuštení náběru jméno pacienta

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To enter the main menu of the device.

To display or hide the incentive picture for children.

5.2.2 MAIN MENU DESCRIPTION

Description of the main menu buttons:

Calibration: Calibration of the pneumotachograph

Unit settings: Open the device settings

Select Patient: Selection, creation or deletion of patient file

Select Physician: Selection of the attending physician