SpiroPro Instruction Manual Ver 2.3

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SpiroPro

Gebrauchsanweisung

Instruction Manual

Version 2.3

Art. No. 780987

®

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Deutsch

User Manual SpiroPro®

English

We congratulate on your purchase of the SpiroPro®, the pocket-sized

spirometer made by VIASYS. Thank you for the confidence you have

placed in us and our product.

All rights reserved. No part of this manual may be reproduced by means of printing, photostatic duplication,

microfilms or any other process, or indeed in part be edited, duplicated or distributed by means of electronic

systems, without the prior written permission of VIASYS. The manual was comprised thoroughly; however, VIASYS

does not assume liability for mistakes or omissions or for casual or consequential damages in connection with

the information contained in this manual. Neither VIASYS nor its subsidiaries are responsible to the customer or

third parties for damages, losses, costs or expenses caused by the customer or third parties due to accidents,

misuse or unauthorized changes, repairs or innovations.

VIASYS is not liable for damages or impairments resulting from the use of options or peripheral equipment from

other manufacturers without the express permission of VIASYS.

Federal U.S.A. Law restricts this device to sale by or on the order of a physician.

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Deutsch

For your Safety

Danger

English

- SpiroPro® is not intended for being operated in potentially explosive rooms or flammable atmospheres. Flammable atmospheres can results from the use of flammable

anesthetics, skin cleansers and skin disinfectants.

- During on-line display a distance of 1.5 m between PC and patient has to be kept and

a SpiroPro on-line adapter must be connected between the SpiroPro® and the lineoperated PC.

Warning

- Avoid fluid getting into the device. If fluid gets into the device, it must only be operated

again after being checked by an authorized service engineer.

Caution

- SpiroPro® is a medical-electrical device which is subject to specific safety precautions

as far as the EMC is concerned. Therefore, SpiroPro® has to be installed and operated

according to the notes on EMC given in the Appendix of this instruction manual.

- Portable and mobile HF telecommunication equipment may impair the function of

SpiroPro®.

- Magnetic and electric fields may impair the function of the device. When operating

the device pay attention that all other devices operated in its vicinity correspond to the

respective relevant EMC requirements. X-ray devices, tomographs, radio plants etc.

can disturb other devices as they are allowed to generate higher electromagnetic interferences.

- Only accessories recommended by VIASYS are allowed to be used. VIASYS is not responsible for the use of accessories of other manufacturers.

- The operator must be familiar with the operation of the device.

- Before using the device, the user has to convince himself/herself of a safe functioning

and proper condition of the device.

- Medical-technical equipment must only be used by personnel who ensure its proper

use due to their training or knowledge and practical experience.

- A qualified physician has to evaluate again all records generated by the computer. A

computer interpretation should only be considered in connection with other clinical

findings.

SpiroPro®

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The easy-to-exchange, high-quality pneumotach guarantees a high degree of patient safety and

provides precise recording results.

Delivery

SpiroPro® and accessories are delivered in a handy bag.

Includes:

1 SpiroPro® spirometer

10 Pneumotachs with attached,

disinfectable mouthpiece

2 Nose clips

1 Lithium-ion battery 3.6 V,

rechargeable

1 Charging unit

1 Printer cable

1 Printer adapter

1 Instruction manual

SpiroPro®

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English

SpiroPro® is a recording and diagnostic system for measurement, recording and assessment of the

Flow-Volume curve and Flow-Volume parameters. The analyzed data can be immediately printed out

or saved to the internal memory.

The portable spirometer is small, easy to handle and allows determination of inspiratory and expiratory lung volumes (VCin, FVC, FEV1, MEF50, ...) including pre and post measurement with date and

time display. An interpretation program automatically assesses the measured data. Optionally, the

measurement of the oxygen saturation of the blood (SpO2) and the pulse rate are available and a 6minute walk test can be performed.

The graphic LCD and the menu-guided graphical user interface comply with the latest technological

developments. Just touch the appropriate icon with your finger to enter patient data or to select menu

items (touch screen). Self-explanatory icons and the logical menu structure safely guide you through

the procedure.

Storage capacity is high: up to 550 measurements can be saved in the internal database.

The rechargeable lithium-ion battery allows operation of the SpiroPro® for approximately two weeks. A

charging unit, able to charge the battery within two hours, is included in the delivery.

Patient data, recording results and graphs can be directly printed out on a PCL-compatible printer (for

example HP DeskJet series). Of course, data transfer to a PC and vice versa is possible via the serial

interface. The optional software package "SpiroPro® for Windows®" allows automatic transfer of data

which are then saved on the PC.

Deutsch

What is SpiroPro® ?

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SpiroPro®

Deutsch

Patient

Pneumotach and

mouthpiece

English

Releaser

Move upwards to change the pneumotach.

LC display

and touch screen

Supplementary pneumotach with mouthpiece

Connection for printer, SpO2 sensor,

battery charger and transfer cable

Battery cover

Pull upwards to open.

Symbols:

!

Attention, follow instruction manual

Equipment of Type BF

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Before operation, the lithium-ion battery, which is included in the delivery, has to be

inserted and charged. The battery was partially charged in the factory.

Insert battery:

Caution

English

Attention

Deutsch

Before Measurement

Pay attention to polarity!

Charge battery:

Only use the charger included in the delivery.

• Connect charger to SpiroPro®.

• Connect the power plug to a 230 V power outlet.

Make sure the power supply is set for local power

requirements.

• Charging will take about 2 hours.

Charger plug

SpiroPro®

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Deutsch

How to Operate your SpiroPro®

SpiroPro® has no mechanical switches. SpiroPro® can be switched on and operated via the touchsensitive screen (touch screen).

To switch on the unit, touch the center of the display for about 3 seconds.

English

The main menu appears.

Switching on, entry of patient data and selection of menu

functions via the touch-sensitive screen.

Note

If the unit is not in use for a certain period of time (four minutes are preset), SpiroPro®

automatically switches off to save energy. The data of the current patient as well as all

settings are retained in the memory.

The Main Menu

Entry of patient data and load or

Battery charging status

delete saved patient data

Print current measurement

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Switch on/off

Select type of measurement:

•Flow-Volume

•Slow Vital Capacity

•SpO2 (option)

•6-Minute Walk Test

Change settings

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A routine measurement is restricted to a few functions.

1. Check ambient conditions

Check ambient conditions once a day and correct them, if necessary.

2. Enter patient data

Enter the patient's personal data or load previously saved patient data from the internal data base.

3. Perform measurement, for example Flow-Volume measurement

Perform the measurement. The data is automatically saved to the internal database.

4. Print out measurement

After the measurement, the results can be printed out.

Enter and Check Ambient Conditions

Attention

As important correction factors are calculated from ambient conditions, they should be

checked at regular intervals. Incorrect or imprecise ambient conditions result in

measuring errors.

Press

in the Main Menu.

The Settings menu appears:

SpiroPro®

Press

.

Press

in the Calibration menu.

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English

Deutsch

Measurement Routine

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The Temperature menu is displayed.

Deutsch

increases the temperature.

decreases the temperature.

English

accepts and saves the value.

±1°C

The Humidity menu appears.

increases humidity.

decreases humidity.

accepts and saves the value.

±5%

The Barometric Pressure menu is displayed.

increases barometric pressure.

decreases barometric pressure.

accepts and saves the value.

±10 hPa

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Returns to the Main Menu without saving the data.

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Before recording starts, the patient's personal data have to be entered. Predicted values are

calculated from patient data so verify that the entered data are correct. Incorrect patient

data produce incorrect predicted values.

In the Main Menu press

data.

to enter patient

English

Attention

The following menu allows you to:

Enter patient data

Load patient and

measuring data

Print all tests of today

Delete patient data

Revert to the Main

Menu

Enter Patient Data

After pressing

, the Name menu appears.

Several letters are assigned to each key. For entering the first letter, for

example "A", press key

once. Press twice for "B" and thrice for

"C". Special characters, such as "^ -" have to be entered via the

key.

Note

At least two characters have to be entered.

Example of entry:

An incorrect entry can be deleted character by character with the

key.

confirms the entry and the First name menu is loaded.

SpiroPro®

Deutsch

Patient Data

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Deutsch

Enter the first name as described above.

confirms the entry and the ID menu is displayed.

English

Because an ID can consist of letters and figures, you can use the

key to switch to the letter entry mode.

It is mandatory to enter an unique ID.

takes you back to the figure entry mode.

Incorrect entries can be deleted with the

key.

confirms the entry and the Sex menu is displayed.

Select either male or female. Your selection is displayed in the status

line.

Continue with

.

Enter the date of birth in the following format: DD.MM.YY or

MM.DD.YY according to your settings. For numbers smaller than 10,

"0" has to be entered to get a two-digit format.

Example: 05.12.52

Continue with

.

Enter height in centimeters or inches according to your settings.

Continue with

.

Enter weight in kilograms or pounds according to your settings.

.

Continue with

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saves the patient data; the

icon appears to directly load the

Flow-Volume measurement program.

Measurements

Depending on the available options, SpiroPro® allows the following measurements:

• Flow-Volume

• Slow Vital Capacity

• Oxygen saturation SpO2 (option)

• 6-Minute Walk Test

Slow Vital Capacity

SpO2

SpiroPro®

Flow-Volume

6-Minute Walk Test

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Deutsch

returns you to the Main Menu without saving the data.

English

Once the entries are completed, an overview of the entered data appears.

Incorrect entries can be amended with the

key.

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A measurement is made by recording the Flow-Volume curve. All diagnostically relevant values of slow

and forced inspiration and expiration can be determined.

English

Deutsch

Flow-Volume Measurement

VC

Vital capacity

FVC

Forced expiratory vital capacity

FEV1

Forced expiratory volume after 1 second

FEV1%VC

FEV1 in % of maximal vital capacity

PEF

Maximal expiratory flow (peak flow)

MEF25

Maximal expiratory flow at 25% of maximal VC

MEF50

Maximal expiratory flow at 50% of maximal VC

MEF75

Maximal expiratory flow at 75% of max. VC

MMEF

Mean maximal expiratory flow between 25% and 75%

of FVC

PIF

Maximal inspiratory flow

FEV6

Forced expiratory volume after 6 seconds

FEV1%FEV6 FEV1 in % FEV6

Flow-Volume curve and parameter definition

Two recording programs are available to perform a Flow-Volume measurement:

1. Program: "Envelope"

2. Program: "ATS"

When using the "Envelope" program, several breathing maneuvers can be performed during a test.

When the test is completed, the program calculates the envelope from which the final recording

values will be derived.

Envelope

Reference: Peslin et al., American Review of

Respiratory Disease, Vol. 119, 271-277; 1979

ATS

Reference: "Standardization of Spirometry 1994 Update", American

Journal of Review of Respiratory and Critical Medicine, Vol. 152,

1107-1134; 1995

The "ATS" (American Thoracic Society) program calculates the best individual measurement on the

basis of the highest sum of FEV1 + FVC.

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Before starting the measurement, verify that a new or a

disinfected pneumotach is used.

starts the measurement.

English

Attention

Note

Instruct the patient to wait and not to breathe via the

pneumotach.

Press

.

Now put a nose clip on the patient's nose and make

sure his/her lips seal around the mouthpiece.

Note

The results depend on the patient's cooperation!

Explain thoroughly the breathing exercise to your patient.

1. Instruct the patient to breathe normally.

2. Then instruct the patient to expire as deeply as possible,

then to inhale to maximum (IC), then to expire as fast and

as far as possible (FVC, FEV1, MEF50, ...), then to inhale

again as fast and as deeply as possible (IVC, PIF).

The breathing maneuvers can be repeated.

Confirm with

and the test will be stopped and evaluated.

If more than one breathing maneuver was performed during

one trial, the best maneuver will be automatically calculated

and displayed. Größte Summe von: FVC + FEV1

SpiroPro®

Deutsch

The recording mode can be selected in the Settings menu. To go to the

Settings menu, press

in the Main Menu and select

and

in the subsequent menus.

To change the recording mode, switch to the "Mode" line by pressing

and select with

either "Envelope curve" or "ATS" .

Confirm the mode by pressing

.

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Deutsch

English

Results after the first trial:

Type of measurement:

Type of measurement:

"Envelope":

"ATS":

Options:

Additional parameters can

be displayed by touching

the parameter field.

The graph can be zoomed

in by touching it.

The graph can be resized

by touching it again.

Note:

When the SpiroPro® has meanwhile switched off (i.e. it is in the energy-saving mode), switch on

the device once again and select the operating mode "Measurement". Of course, the data of the

current patient are retained in the memory.

Adds a further trial to

the current measurement

Starts a new

PRE-measurement

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Starts a dilatation

measurement (POST-measurement)

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Deutsch

Perform Additional Trials

As the flow-volume measurement is highly dependent on patient cooperation, we recommend performing one or more additional trials.

English

"Envelope" set

Results after the first trial:

Perform

additional trial

Start measurement

If the results of the new trial are better (highest sum of FEV1+FVC) than those of the previously

performed trial, they will be saved automatically.

If the results are worse, they will be displayed but not saved.

Note

Only the best trial will be saved.

"ATS" set

Results after the first trial:

Perform additional trial

Note

The best three trials will be saved!

Three trials are recommended by the ATS.

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Additional symbols available in ATS mode

English

calculates the best trial according to the formula "Highest sum of FEV1+FVC" (provided that

several trials have been performed).

displays ATS error message(s) in case of incorrect measurement.

shows the zoomed curve(s) as well as the parameters FEV1 and FVC of all available trials

(maximally three).

The "X" in the column titled "A" means that the trial is

accepted according to ATS criteria.

marks the next trial.

!

deletes the marked trial.

the best curve will be recalculated and saved automatically.

Back.

prints the displayed results.

stops the measurement and the Main Menu appears.

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SpiroPro®

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English

If a measurement is performed and "ATS" is set, the system will automatically check whether the

results are acceptable and reproducible.

The results of an individual measurement are regarded to be acceptable on the basis of the following

criteria:

- Expiration must at least be 6 seconds and an end-expiratory plateau must be present, i.e.

the recorded volume must not be higher than 30 ml during the last second,

- or expiration must be longer than 15 seconds,

- and back-extrapolated volume must be < 5% of FVC or 150 ml.

The accepted individual trial will then be summed up (Sum Measurement).

The Sum Measurement is composed of the biggest curve (highest sum of FVC+FEV1) and the

highest individual values for FVC and FEV1 from all accepted individual measurements.

Special case:

If none of the individual measurements is accepted, the sum curve will be composed of all (not

accepted) measurements (acc. to the procedure described above).

Next, reproducibility is checked according to the following criteria:

- Variability of FVC < 0.2 L

- and variability of FEV1 < 0.2 L

Reproducibility is defined as the difference between the two highest values of the respective parameter. Only accepted trials are used.

If there are less than two accepted individual measurements, reproducibility will not be checked. If

less than three accepted trials exist, the message „insuf. # of acceptable efforts“ will appear.

Deutsch

Determination of the Best Trial acc. to ATS Criteria

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Once a test has been made or a patient's recorded data have been loaded, the data can be printed out

on a PCL-compatible printer, i.e., HP Deskjet series (exception: HP Deskjet 7xx).

Preparation:

English

Deutsch

Print Recorded Results

• Connect the cable included in the delivery to the

appropriate printer port and fix it with the two

clamps.

Attention

Connect the printer cable to the socket at

the bottom part of the SpiroPro®.

• Switch on the printer!

Printing is started by touching the

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key!

SpiroPro®

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SpiroPro®

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English

Deutsch

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Typical Flow-Volume Curves in Healthy and Ill Subjects

no forced expiration

no maximum expiration

English

normal flow-volume curve

The inspiratory curve typically shows a semicircular pattern. The expiration curve shows a rapid rise in

the first 10% of exhalation, reaches the peak expiratory flow (PEF) and then falls almost linearly from

there to the residual volume. The flows are in the individual normal range in each case.

Normal curve and curves produced with bad cooperation

In obstructive ventilation disorder, the whole curve pattern is deformed in a typical manner. The expiratory

curve has a clearly convex shape, representing the reduction of the expiratory flows over the whole

exhalatory range. The degree of deformation is decisive for the severity of the disease.

Flow-Volume curve in presence of airway obstruction

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English

The curve produced by a respiratory collapse is similar to that of an airway obstruction, it is, however,

more distinctive. The kink of the Flow-Volume curve corresponds to a collapse of the central and

peripheral airways. Respiratory collapse is often accompanied by a loss of alveolar surface (=

emphysema).

Flow-Volume curve in presence of respiratory collapse

In restrictive ventilation disorder, the actual shape of the Flow-Volume curve is largely

preserved. However, vital capacity (VC) as well as the flows (MEF) are greatly reduced.

Flow-Volume curve in case of restriction

Flow-Volume curves in case of stenoses

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If an airway obstruction is detected the question as to its reversibility automatically arises (i.e. if it can

be cured or not). If the parameters indicate an airway obstruction, a bronchospasmolysis test (dilation) is performed.

The Flow-Volume curve shows the immediate bronchospasmolytic effect. The expiratory portion of the Flow-Volume

curve and consequently, maximal peak flow (PEF), peak

flows at 75, 50 and 25% of thoracic vital capacity (MEF75,

MEF50, MEF25) as well as forced vital capacity (FVC)

change.

English

Deutsch

Perform Dilation Measurement

Procedure

1. During the patient's visit a Flow-Volume measurement (basic measurement) is performed. If the

results indicate an airway obstruction, a bronchospasmolysis test is performed.

2. The patient has to inhale a commercially available, short-term ß2 adrenergic. Onset of effect can

be expected after at least 10 minutes. If a long-term ß2 adrenergic is taken, it is recommended to

wait for 20 to 30 minutes before bronchospasmolysis test is performed.

3. Perform a Flow-Volume measurement after inhalational bronchospasmolysis (dilation measurement).

Perform a dilation measurement

1. Basic measurement

starts the measurement.

Perform the test as described before.

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2. Administer bronchodilator and perform measurement.

Attention

Dosage has to be individually adjusted and is incumbent on the doctor. Please

adhere to the manufacturers' instructions for use.

The dilation measurement can be started after waiting for a period of time (for example

10 minutes) for the drug to take effect.

As SpiroPro® has switched off during the waiting period (i.e. it is in the energy saving

mode), switch it on again and select the operating mode "Measurement".

Start dilation measurement

Perform a Flow-Volume measurement as described above.

Display after measurement:

The "Act" column lists the parameters of the dilation measurement.

The "%Diff" column shows the deviation of the dilation measurement

as compared to the basic measurement in percent.

The graph can be zoomed

in by touching it.

Values of, for example, 130% indicate that the bronchospasmolysis test

improved the lung function parameters by 30%. This is called a reversible airway obstruction.

Dilation measurement

Basic measurement

SpiroPro®

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English

Deutsch

Display of basic results: