Cosmed SpirHOMEter User Manual

Cosmed does not assume the liability for interpretation mistakes of this
documentation or for casual or consequential damages in connection with the
provision, representation or use of this documentation.

No parts of this manual may be reproduced or transmitted in any form without
the express permission of COSMED Srl.

COSMED Software can be installed only in one device.

Excel is a registered trademark of Microsoft Corporation.
DBIII is a registered trademark of Bordland International Inc.
Lotus 123 is a registered trademark of Lotus Development Corporation .

SpirHOMEter User manual, III Edition
September 2003

Copyright © 1999 COSMED

Copyright © 2003 COSMED

COSMED Srl - Italy

http://www.cosmed.it

Part N. C02046-02-91

Table of contents

Getting started 7

Important notices.................................................................... 8

Intended use............................................................................................ 8

Warnings................................................................................................. 8

Contraindication ................................................................... 11

Absolute contraindications.................................................................... 11

Relative contraindications.....................................................................11

Environmental condition of use ............................................ 12

Safety and conformity ........................................................... 13

Safety.............................................................................................. 13

EMC ............................................................................................... 13

Quality Assurance...........................................................................13

Medical Device Directive (CE mark) ............................................. 13

Keynotes................................................................................ 14

Typographic keynotes........................................................................... 14

Graphic keynotes .................................................................................. 14

Before starting ...................................................................... 15

Checking the packing contents .............................................................15

SpirHOMEter standard packaging.................................................. 15

Kit software SpirHOMEter standard packaging ............................. 15

Warranty registration ........................................................... 16

Register the product via software ...................................................16

How to contact COSMED.............................................................. 16

Complain, feedback and suggestions.............................................. 16

PC configuration required .................................................... 17

Technical features ................................................................. 18

Measurements 19

Measured parameters .......................................................... 20

Installation 21

Prepare the SpirHOMEter..................................................... 22

2 - SpirHOMEter User Manual

Install/replace batteries......................................................................... 22

Install the turbine.................................................................................. 22

Turn on the device................................................................................ 23

Set-up the SpirHOMEter ........................................................24

The keyboard........................................................................................ 24

Access to Control Menu....................................................................... 24

Delete stored data................................................................................. 25

Transmit data to the PC........................................................................ 25

Calibrate the flowmeter ........................................................................ 25

Set-up date and time............................................................................. 25

Modem option ...................................................................................... 26

Set-up patient data................................................................................ 26

Set-up the device .................................................................................. 27

Software installation .............................................................28

Installing the software .......................................................................... 28

Run the software................................................................................... 28

PC port configuration........................................................................... 28

Software main features .........................................................29

Display ................................................................................................. 29

Tool bar................................................................................................ 29

Show/hide the toolbar..................................................................... 29

Dialog windows.................................................................................... 29

Use of the keyboard ....................................................................... 29

Use of the mouse............................................................................ 29

Scroll bars............................................................................................. 30

On-line help.......................................................................................... 30

Software version................................................................................... 30

Calibration 31

Turbine calibration ................................................................32

Database Management 33

Settings ..................................................................................34

Graphs............................................................................................ 34

Serial port....................................................................................... 34

Units of measurements ................................................................... 35

Using extra fields ........................................................................... 35

Index - 3

Customise the fields........................................................................ 35

Patient's database ................................................................ 36

Patient Card .................................................................................... 36

Visit Card .......................................................................................37

Test Card ........................................................................................37

Import/export a Tests card .................................................................... 37

Diagnosis Database............................................................................... 37

Transmit data to the PC ........................................................ 39

Transmit data ........................................................................................ 39

Link the test to a patient in the archive .................................................40

Archive maintenance ............................................................ 41

Reorganise the archive.......................................................................... 41

Delete the archive ................................................................................. 41

Backup and restore................................................................................41

Backup............................................................................................ 41

Restore............................................................................................ 42

Spirometry 43

Setting spirometry options ................................................... 44

Spirometry ............................................................................................ 44

Automatic Interpretation.................................................................44

Quality control................................................................................ 45

Parameters manager.............................................................................. 45

Predicted values manager .....................................................................46

Predicteds set.................................................................................. 46

Set the current predicted................................................................. 47

Formula definition.......................................................................... 47

Page set-up............................................................................................ 48

Spirometry tests .................................................................... 50

Tips for correct use of the device.......................................................... 50

Keyboard ..............................................................................................50

Drugs ....................................................................................................50

Recording the severity of symptoms..................................................... 51

Performing the test................................................................................ 51

Viewing results...................................................................... 53

Tests of the current patient .............................................................53

Delete a test .................................................................................... 53

4 - SpirHOMEter User Manual

View a trend ......................................................................................... 54

Printing results.......................................................................56

Printing Reports.................................................................................... 56

Printing the active window................................................................... 56

Printing a series of reports.................................................................... 57

Electronic reports (*.pdf)...................................................................... 57

Export data ........................................................................................... 57

Export a test ................................................................................... 57

System maintenance 59

System maintenance..............................................................60

Cleaning and disinfection..................................................................... 60

Cleaning the turbine flowmeter...................................................... 61

Precautions during the cleaning of the turbine ............................... 61

Suggested disinfection solutions .................................................... 62

Inspections............................................................................................ 62

Replace the batteries............................................................................. 62

Appendix 63

Service - Warranty.................................................................64

Warranty and limitation of liability...................................................... 64

Return goods policy for warranty or non warranty repair..................... 65

Repair Service Policy........................................................................... 65

Privacy Information ...............................................................67

Personal data treatment and purposes................................................... 67

How your personal data are treated ...................................................... 67

The consent is optional, but….............................................................. 67

Holder of the treatment......................................................................... 67

Customer rights .................................................................................... 68

ATS 94 recommendations......................................................69

ATS recommendations......................................................................... 69

Predicted values ....................................................................70

ERS93 .................................................................................................. 70

Reference Adult: ............................................................................ 70

Reference Paediatric:...................................................................... 70

KNUDSON 83 ..................................................................................... 70

Reference Adult/ Paediatric: .......................................................... 70

Index - 5

ITS (White race) ................................................................................... 70

Reference Adult/ Paediatric:........................................................... 70

ITS (Black race).................................................................................... 70

Reference Adult/ Paediatric:........................................................... 70

LAM ..................................................................................................... 71

Reference Adult/ Paediatric:........................................................... 71

Multicéntrico de Barcelona................................................................... 71

Reference Adult/ Paediatric:........................................................... 71

NHANES III......................................................................................... 71

Reference Adult/ Paediatric:........................................................... 71

Automatic diagnosis (algorithm) ..........................................................71

Quality Control Messages..................................................................... 72

References ............................................................................. 73

6 - SpirHOMEter User Manual

Getting started

Important notices

Intended use

SpirHOMEter is an electrical medical device designed to perform
pulmonary function tests. It is to be used by physicians or by
trained personnel on a physician responsibility.

Caution: Federal law restricts this device to sale by or on the
order of a physician.

This equipment has been conceived with the aim of providing an
auxiliary instrument allowing:

• the formulation of lung pathology diagnosis;

• important studies concerning human physiology;

• the collection of important information in sport medicine.

No responsibility attaches COSMED Srl for any accident
happened after a wrong use of the device, such as:

• use by non qualified people;

• non respect of the device intended use;

• non respect of the hereunder reported precautions and

instructions.

Warnings

The device, the program algorithms and the presentation of
measured data have been developed according to the
specifications of ATS (American Thoracic Society) and ERS
(European Respiratory Society). Other international references
have been followed when these were not available. All
bibliography references are reported in Appendix.

The present handbook has been developed with respect of the
European Medical Device Directive requirements which sort
SpirHOMEter within Class II a.

It is recommended to read carefully the following precautions
before putting the device into operation.

The precautions reported below are of fundamental importance to
assure the safety of all COSMED equipment users.

1. This user manual is to be considered as a part of the medical
device and should always be kept on hand.

2. Safety, measure accuracy and precision can be assured only:

8 - SpirHOMEter User Manual

• using the accessories described in the manual or given
with the device. Actually non recommended accessories can
affect safety unfavourable. Before using non recommended
accessories it is necessary to get in touch with the
manufacturer;

• ordinary equipment maintenance, inspections,
disinfection and cleaning are performed in the way and with
the frequency described;

• any modification or fixing is carried out by qualified
personnel;

• the environmental conditions and the electrical plants
where the device operates are in compliance with the
specifications of the manual and the present regulations
concerning electrical plants. In particular grounding
reliability and leakage current suppression can only be
assured when the device three – wire receptacle is connected
to a yellow - green return connected to earth ground.
Attempting to defeat the proper connection of the ground
wire is dangerous for users and equipment.

3. Before powering the system, check the power cables and the
plugs. Damaged electrical parts must be replaced
immediately by authorised personnel.

4. Cleaning residue, particulates, and other contaminates
(including pieces of torn or broken components) in the
breathing circuit pose a safety risk to the patient during
testing procedures. Aspiration of contaminates can
potentially be life-threatening. You must follow all the
cleaning procedures in System Maintenance, and you must
thoroughly inspect the components after cleaning and before
each patient test.

5. This device is not suitable for use in presence of flammable
anaesthetics. It is not an AP nor an APG device (according to
the EN 60 601-1 definitions).

6. Keep the device away from heat and flame source,
flammable or inflammable liquids or gases and explosive
atmospheres.

7. In accordance with their intended use SpirHOMEter is not to
be handled together with other medical devices unless it is
clearly declared by the manufacturer itself.

Chapter 1 - Getting started - 9

8. It is recommended to use a computer with electromagnetic
compatibility CE marking and with low radiation emission
displays.

9. It is necessary to make the PC, connected to the
SpirHOMEter, compliant with EN 60601-1 by means of an
isolation transformer.

10. Graphical symbols used in accordance to present
specifications are described here below:

Equipment type B (EN60601-1)

Danger: high temperature

OFF

ON

Protective earth ground

Alternating current

10 - SpirHOMEter User Manual

Contraindication

The physical strain to execute the respiratory manoeuvre is
contraindicated in case of some symptoms or pathology. The
following list is not complete and must be considered as a piece
of mere information.

Absolute contraindications

• Post-operating state from thoracic surgery

• Severe instability of the airways (such as a destructive

bronchial emphysema)

• Bronchial non-specific marked hypersensitivity

• Serious problems for the gas exchange (total or partial

respiratory insufficiency)

Relative contraindications

• spontaneous post-pneumothorax state

• arterial-venous aneurysm

• strong arterial hypertension

• pregnancy with complications at the 3

rd

month.

Chapter 1 - Getting started - 11

Environmental condition of use

COSMED units have been conceived for operating in medically
utilised rooms without potential explosion hazards.

The units should not be installed in vicinity of x-ray equipment,
motors or transformers with high installed power rating since
electric or magnetic interferences may falsify the result of
measurements or make them impossible. Due to this the vicinity
of power lines is to be avoided as well.

Cosmed equipment are not AP not APG devices (according to
EN 60601-1): they are not suitable for use in presence of
flammable anaesthetic mixtures with air, oxygen or nitrogen
protoxide.

If not otherwise stated in the shipping documents, Cosmed
equipment have been conceived for operating under normal
environmental temperatures and conditions [IEC 601-1(1988)/EN
60 601-1 (1990)].

• Temperature range 10°C (50°F) and 40°C (104°F).

• Relative humidity range 20% to 80%

• Atmospheric Pressure range 700 to 1060 mBar

• Avoid to use it in presence of noxious fumes or dusty

environment and near heat sources.

• Do not place near heat sources.

• Cardiopulmonary resuscitation emergency equipment

accessible.

• Adequate floor space to assure access to the patient during
exercise testing.

• Adequate ventilation in the room.

Notice: if accidentally droppings, exposure to heat source and
excessive humidity may compromise the validity of the system, we
recommend you a check or ask for a technical assistance.

12 - SpirHOMEter User Manual

Safety and conformity

Safety

IEC 601-1 (1988) /EN 60 601-1 (1990);

Find reported below the complete classification of the device:

• Electrical internally powered equipment type B

• Protection against water penetration: IP00, ordinary

equipment unprotected against water penetration

• Non sterile device

• Device not suitable in the presence of flammable

anaesthetics;

• Continuous functioning equipment;

EMC

SpirHOMEter meets the EMC Directive 89/336

EN 60601-1-2

EN 55011 Class B (emission), IEC 1000-4-2, IEC 1000-4-3, IEC
1000-4-4

Quality Assurance

UNI ISO 9001 (Registration n° 387 Cermet)

Medical Device Directive (CE mark)

MDD 93/42/EEC (Notified Body 0476).

Class IIa

Chapter 1 - Getting started - 13

Keynotes

Here are the keynotes used to make the manual easier to read.

Typographic keynotes

These are the typographic keynotes used in the manual.

Style Description

Bold indicates a control or a key to be pressed.

“Italic” indicates a messages shown by the firmware.

Graphic keynotes

These are the graphic keynotes used in the manual.

Illustration Description

shows the button to click in the software to

activate the related feature.

14 - SpirHOMEter User Manual

Before starting

Before operating the SpirHOMeter we strongly recommend to
check the equipment and register you as a customer.

Checking the packing contents

SpirHOMEter and its software are in two different packaging,
because it is necessary only one software to manage more units.

The first purchase will be of two packages:one containing the
software, the other one the SpirHOMEter. Make sure that the
packing boxes contain the items listed below. In case of missing
or damaged parts, please contact your nearest COSMED
technical assistance.

SpirHOMEter standard packaging

Code Qty Description

C00486-01-05 1 SpirHOMEter unit

C00033-01-05 1 Turbine

A 662 100 001 1 Nose clips

C00063-01-20 2 Conic mouthpiece

C00066-01-10 1 Carrying case

A 410 110 001 4 AAA battery 1,5 V

C00067-02-94 1 Registration card

C01999-02-DC 1 Conformity declaration

C00065-02-91 1 Patient manual

Kit software SpirHOMEter standard packaging

Code Qty Description

C02053-02-35 1 PC software

C00021-01-30 1 9 pin F adaptor

C00674-01-12 1 Interface cable RS232

C00067-02-94 1 Registration card

C02046-02-91 1 User manual

Chapter 1 - Getting started - 15

Warranty registration

Before using the system, please take a moment to fill in the
registration form and the warranty and return them to COSMED,
by doing this you are eligible to the customers assistance service.

For further information, please refer to the enclosed registration
and warranty form. If the form is not enclosed in the packaging,
please contact directly COSMED.

Register the product via software

Together with the PC software, a registration software is
supplied. With this software it is possible to fill in an electronic
form with the customer information.

1. To run the software, double click on the icon Registration or
select Registration… from ? menu.

2. Type the requested information and click Send… to send the
form via e-mail to COSMED.

How to contact COSMED

For any information you may need, please contact the
manufacturer directly at the following address:

COSMED S.r.l.
Via dei Piani di Monte Savello, 37
P.O. Box n. 3
00040 - Pavona di Albano
Rome - ITALY

Voice: +39 (06) 931.5492
Fax: [phone]
email: [e-mail]
Internet: http: //www.cosmed.it

Complain, feedback and suggestions

If you have any complain, feedback information or suggestion,
please inform us at [e-mail].

16 - SpirHOMEter User Manual

PC configuration required

• Pentium 133 MHz.

• Windows 95, 98, XP.

• 16 Mb RAM .

• 3.5 drive.

• VGA, SVGA monitor.

• Serial Port RS 232 available.

• Any Mouse and Printer compatible with the MS Windows™

operative system.

• PC conform to European Directive 89/336 EMC

Chapter 1 - Getting started - 17

Technical features

Flowmeter Bidirectional digital turbine

Flow Range: 0.03 - 20 l/s

Volume Range: 12 l

Accuracy: ± 3% or 50 ml

Resistance @12 l/s: < 0.7 cmH2O/l/sec

Memory: 120 tests

Display: LCD 2 lines x 16 char

Keyboard: 4 multi-function keys

Serial port: RS232C

Power supply: 4 AAA 1,5V batteries

Dimensions: 175 x 35 x 35 mm

Weight: 120g

18 - SpirHOMEter User Manual

Measurements

Measured parameters

Symbol UM Parameter

FVC l Forced Expiratory Vital Capacity

FEV1 l Forced Expiratory Volume in 1 sec

FEV1/FVC% % FEV1 as a percentage of FVC

PEF l/sec Peak Expiratory Flow

FEV0.5 l Forced Expiratory Volume in 0.5 sec

FEV6 l Forced Expiratory Volume in 6 sec

FEV1/FEV6 % FEV1 as a percentage of FEV6

FEV6/FVC% % FEV6 as a percentage of FVC

Best FVC l Best Forced Expiratory Vital Capacity

Best FEV1 l Best Forced Expiratory Volume in 1 sec

Best PEF l/sec Best Peak Expiratory Flow

Vmax25% l/sec Expiratory Flow @25% of the FVC

Vmax50% l/sec Expiratory Flow @50% of the FVC

Vmax75% l/sec Expiratory Flow @75% of the FVC

FEF25-75% l/sec Mid-exp flow between 25-75%FVC

FET100% sec Forced expiratory time

FEV2 l Forced Expiratory Volume in 2 sec

FEV3 l Forced Expiratory Volume in 3 sec

FEV2/FVC% % FEV2 as a percentage of FVC

FEV3/FVC% % FEV3 as a percentage of FVC

FEV1/VC% % Tiffenau index

FEF50-75% l/sec Mid-exp flow between 50-75%FVC

FEF75-85% l/sec Mid-exp flow between 75-85%FVC

FEF0.2-1.2% l/sec Mid-exp flow between 0.2 l - 1.2 l

FiVC L Inspiratory Forced Vital Capacity

FiF25-75% l/sec Forced mid-inspiratory flow

FiV1 l/sec Forced Inspiratory Volume in 1 sec

PIF l/sec Peak Inspiratory Flow

VEXT ml Extrapolated Volume (back extrapolation)

PEFT msec Time to PEF (10% - 90%)

20 - SpirHOMEter User Manual

Installation

Prepare the SpirHOMEter

Install/replace batteries

The devices is battery operating. It uses 4 manganese alkaline
AAA-size 1,5V batteries.

1. The on/off switch must be set to 0.

2. Remove the battery compartment cover.

3. Insert the batteries as indicated on the back side of the
device.

4. Close the battery compartment.

It is suggested to replace the batteries only if you have the new
ones. The SpirHOMEter, without batteries, retains the stored data
only few minutes.

Note: If you don't use the SpirHOMEter for a long time, remove
the batteries, being careful to save on the PC the tests in the unit
memory.

Install the turbine

Remove the transparent wrapping and insert the turbine as shown
in the following figure. Be sure to push the turbine up to touch
the end of the holder.

22 - SpirHOMEter User Manual

Turn on the device

Set the on/off switch to I.

Note: If the switch is already set to I, but the display doesn't
show anything, turn off and then turn on the device. The
SpirHOMEter, if not used, turn off itself automatically after
about one minute.

Chapter 3 - Installation - 23

Set-up the SpirHOMEter

The SpirHOMEter has controls for data transmission, archive
deletion, setting date and time. In order to use these controls, you
have to access a menu that, from now on, will be called Control
menu.

The keyboard

The keyboard is made of the following keys:

Deletion

Transmission

Calibration

Configuration

For the sake of ease, we shall refer to the SpirHOMEter keys
with the numbers they represent on the keyboard: 0, 1, 2 and 3
respectively.

Access to Control Menu

1. Hold the key 3 down and, at the same time, switch on the
device by setting the on-off switch to I.

2. Release the key 3, and the display panel will display a menu,
different from that accessible by the patient.

By pressing the respective keys it is possible to:

0 delete all the data stored in the memory

1 transmit stored data to the PC via RS-232 or via modem

2 calibrate the flowmeter

3 adjust the internal clock, configure the modem option and

set up the patient data.

Let us exhamine these functions in detail.

24 - SpirHOMEter User Manual

2.Calib 3.Config

1.Trans 0.Cancel

Delete stored data

Before the SpirHOMEter is delivered to the patient, it must be
reprogrammed to free up the memory, used during the last
session.

1. Access the control menu

2. Press the key 0 (deletion). The following message will
appear:

3. Press in succession the keys 3, 1, 0, 2.

At the end of this operation, the following message will appear
on the display of the device:

Transmit data to the PC

This function is described in the chapter Database management.

Calibrate the flowmeter

This function is described in the chapter Calibration.

Insert

secret code

MEMORY EMPTY

(Press any key)

Set-up date and time

In order to set up the date and the time:

1 Access the control menu

2 Press the key 3 to enter in configuration

3 Press the key 3 (date).

Date Time

05/04/03 08:55

4 Move into the fields dd/mm/aa – hh/mm, by means of the

key 3

5 Modify the time and/or the date with the key 2 (forward) or 1

(backward)

6 Confirm with the key 0.

Chapter 3 - Installation - 25

Modem option

With this option, the patient can send his/her tests via modem,
directly from his/her own home.

To configure the modem option (to store the phone number to be
called):

1 Access the control menu

2 Press the key 3 to enter in configuration

3 Press the key 1 (modem).

4 To configure the transmission type (tone or pulse), press the

key 1 (the setting switches between tone and pulse, the
selected setting is the one in capital letters).

5 To set up the telephone number, press the key 2 and then

modify the ciphers by means of the keys 2 (increase) and 1
(decrease), moving by means of the key 3.

6 At the end of the entry, set up the character #

7 Confirm with the key 0.

Set-up patient data

This function allows the user to set up the ID code and the best
PEF of the patient.

It is very important setting-up correctly the ID code of the
patient: this code is used to refer the test data, transmitted to the
PC through serial or modem connection, to the proper patient
card.

To set-up the patient data:

1 Access the control menu

2 Press the key 3 to enter in configuration

3 Press the key 2 (paziente).

4 To set up the best PEF press the key 1. To decrease or

increase the displayed value, press respectively the key 1 or

2. Confirm with the key 0.

5 To set up the ID code of the patient, press the key 2 and then

modify the ciphers by means of the keys 2 (increase) or 1
(decrease), moving by means of the key 3. Confirm with the
key 0.

26 - SpirHOMEter User Manual

Set-up the device

When the SpirHOMEter is left without power for a relatively
long period of time, when turned on it displays the following
message:

Note: When this message appears, any data stored in the device
are lost. Delete the stored data as already described.

Setup

the memory...

Chapter 3 - Installation - 27

Software installation

Installing the software

1. Select Run... from Windows Start menu.

2. In the Command line box, type a:\install (assuming the disk
is in drive A:).

3. Click on OK (or press ENTER key).

4. The program will load up a dialog box and ask for a
directory where to be installed.

5. When the installation is over, the program will advise you
with a message indicating that the installation has been
successfully completed, click on End.

Notice: The software is copy-protected. Install the software from
the original disk.

Run the software

1. In the Windows Start menu, open the Program Group in
which the software was installed.

2. Click the SpirHOMEter icon.

PC port configuration

The first time the software is used, it is necessary to configure the
communication port with the PC (USB, COM1, COM2,…).

For further details, see the chapter Database management.

28 - SpirHOMEter User Manual

Software main features

Display

The program may contain several windows. The active window
is highlighted with a different colour of the caption. Some
functions of the program are "active window" sensitive (Print,
right key of the mouse).

Tool bar

Many of the functions that may be selected from the menu can be
activated more rapidly by clicking with the mouse on the
corresponding icon in the tool bar.

Positioning the mouse cursor on one of the buttons of the toolbar
(if the option Hints is enabled), the description of the
corresponding function is shown in a label.

Show/hide the toolbar

Select Toolbar from Options menu in order to show or hide the
toolbar.

Dialog windows

The typical operating environment of Microsoft Windows is the
Dialog box. This window is provided with a series of fields in
which input the information.

Use of the keyboard

• To move the cursor among fields, press the Tab key until
you reach the desired field.

• Press the Enter key to confirm the information input on the
dialog box or press the Esc key to cancel changes.

Use of the mouse

• To move the cursor among fields, move the mouse on the
desired field and left-click.

• Click on the OK button with the Left button of the mouse to
confirm the information input on the dialog box or click on
Cancel button to cancel changes.

Chapter 3 - Installation - 29

Scroll bars

Some windows are provided with scroll bars that help to see data
exceeding the window space available.

• To move the scroll bar row by row click the scroll arrows at

• To move the scroll bar page by page click on the grey area at

On-line help

COSMED Help is a complete on-line reference tool that you can
use at any time. Help is especially useful when you need
information quickly or when the user manual is not available.
Help contains a description of each command and dialog box,
and explains many procedures for accomplishing common tasks.

To get the Help on line, press the F1 key.

Software version

To know the software version and the serial number of the
software, select About SpirHOMEter… from Help menu.

the end of the scroll bars

both sides of the scroll fields

30 - SpirHOMEter User Manual

Calibration

Turbine calibration

The SpirHOMEter is calibrated by COSMED. ATS recommends
a daily calibration of the turbine. However if it is correctly
maintained, turbine retains its precision for longer periods. We
advice to calibrate the turbine daily to detect malfunctioning.

The check must be carried out measuring a known volume
(calibration syringe) carrying out a FVC test, and verifying the
measured value. If the difference between the predicted (real) and
the measured value is greater than 3%, it is necessary to carry out
the calibration procedure.

In order to calibrate the turbine:

1. Access the control menu.

2. Press the key 2. The following message will appear.

3. To cancel the operation, press the key 0.

4. To restore the factory settings, press the key 1.

5. To carry out a new calibration, connect the calibration
syringe to the turbine and press the key 2.

6. Perform 2 or 3 complete inspirations/expirations and wait for
a message similar to the following one:

Pred represents the real syringe volume, Meas the measured

volume, %Corr the applied correction (in percent).

7. Press a key. The following message will be displayed:

K indicates the new calibration factor.

8. Press the key 1 if you want to store the new calibration
factor, otherwise 2 to cancel the operation.

The 3-liters calibration syringe can be purchased directly from
COSMED (P/N C00243-01-06).

2.New K=128

1.Standard 0.Esc

Pred Meas %Corr

3.00 3.32 -9.7

2.Cancel New

1.Store K=089

Note: If a bacterial filter is used for the tests, do use it also
during the turbine calibration.

32 - SpirHOMEter User Manual

Database

Management

Settings

The software allows to configure some options selecting
Configure from the Option menu.

Graphs

All the graphs visualised and/or printed can be customised in
colours and appearance.

1. Select the desired colours of the curves (5 curves max can be
overlapped on the same graph).

2. Enable or disable the Grid option.

3. Enable or disable the Show Info Test option.

Serial port

You must select the serial port RS 232 that will be used to
connect the SpirHOMEter with the PC.

To select the serial port, click on the proper COM button (the
selected port must be different from the mouse one).

34 - SpirHOMEter User Manual

Units of measurements

It is possible to configure the units of measurements, weight and
height, for printing and viewing.

To select the units of measurement click on cm/Kg or in/lb
according to the desired format.

Using extra fields

The Patient’s database is organised in 3 different cards (Patient
card, Visit Card and Test card.) where it is possible to store the
information about patients and visits.

Besides the standard information, it is possible to customise some
fields (user free fields), entering and labelling measurements
coming from other devices.

The customisable free fields are:

• 3 fields in the Patient Card (Patient’s information)

• 3 fields in the Visit Card (information about the visits)

• 3 fields (2 numeric) in the Test card information about Test)

Customise the fields

In the group User free fields type the desired text in the 9 fields
available.

Chapter 5 - Database Management - 35

p

Patient's database

The Patients database consists of a Patient Card, a Visit Card and
a Test Card in which are listed all tests performed by the patient.

Select Archive Navigator from the File menu or press the
button by side.



Note: after having
deleted a record
(patient, visit or
test), it is
recommended to
reorganize the
archive in order to
free disk s

ace.

Patient Card

It collects all the information of a patient (first name, last name,
date of birth) which remain the same for each visit. For each
patient there is only one Patient Card, which is created the first
time the Patient performs a test.

To move within the database use the following buttons:

Move to the first patient in the archive

Move to the previous patient in the archive

Move to the next patient in the archive

Move to the last patient in the archive

Find a patient in the archive

Enter a new patient in the archive

Delete current patient from the archive

Edit the current patient card

36 - SpirHOMEter User Manual

Visit Card

It collects all information relative to the visit (diagnosis, visit
description...) and to the patient information subject to change
between one visit and another (height, weight, smoke). Each
patient can be related to several Visit Cards provided they have
been created in different days. Before carrying out any
spirometric test it is necessary to create a new Visit Card or to
open the today’s Visit Card.

To move within the database use the following buttons:

Move to the first visit in the archive

Move to the previous visit in the archive

Move to the next visit in the archive

Move to the last visit in the archive

Find a visit in the archive

Enter a new visit card in the archive

Delete current visit card from the archive

Edit the current visit card

Test Card

It contains all the information about the test.

To move within the database use the following buttons:

Delete current test from the archive.

Edit the current test

Import/export a Tests card

This function allows to import /export a test card with the
respective visit and patient card.

1. Select the patient.

2. Choose the tests to be exported and press the key by side. All
data will be imported/exported in the XPO file format
(Cosmed proprietary).

Diagnosis Database

The program allows to manage a diagnosis database, whose
records are composed by a diagnosis ID code and a string of text.

Chapter 5 - Database Management - 37

The report of the visits can be done either by typing the desired
text in the field “Diagnosis” of the Visit Card or, more quickly,
retrieving from the diagnosis database the desired one.

If you want to insert, modify or delete a diagnosis from the
database select Database Diagnosis... from the File menu.

38 - SpirHOMEter User Manual

Transmit data to the PC

Before starting any analysis you must upload the data from the
spirometer via the serial port. This operation is made up of the
two following steps:

1. Transmit data

2. Link the test to a patient in the archive

Transmit data

1. Link up the spirometer to the PC with the RS232 cable
supplied.

2. Select Receive from the Test menu

3. Access the control menu

4. Press the key 1 to enter data transmission.

5. Press another time the key 1 to select the transmission
towards PC.

6. Confirm pressing the Receive button on PC.

7. Start data transmission from the spirometer by pressing any
key.

A solid bar on the PC display will highlight the state of data
acquisition from the SpirHOMEter.

Note: Be sure that the program is correctly configured to acquire
data through the serial port (COM1 or COM2) as previously
described.

At the end of the data transmission, if reception has taken place
correctly, the program will open a window to link the tests to the
patient (see later). The SpirHOMEter display will show the
following message:

Check the

data rec’d

Chapter 5 - Database Management - 39

Link the test to a patient in the archive

The data received from the spirometer are held in temporary
memory. These tests must then be stored within the patient
database by linking each test to the corresponding patient.

1. Select Link from the Test menu.

2. Select the test you want to link in the top area of the window.

Move to the first test to link

Move to the previous test to link

Move to the next test to link

Move to the last test to link

Delete current test

View a preview of the report

3. Select the correspondent Patient in the bottom area of the
window.

Find a patient in the archive by the Archive Navigator

Id Find a patient in the archive with the same ID Code of

Link Link the current test to the current patient.

40 - SpirHOMEter User Manual

the current test to link.

Archive maintenance

The software allows to manage files selecting Archive from the
File menu.

It is advisable to perform the archive reorganisation every month,
in order to free space on the hard disk and/or to correct possible
errors present within the database.

It is possible also that your have no more hard disk space. So,
you have to delete all the data. In this case, it is useful to perform
the initialising.

Reorganise the archive

1. Select Reorganize archive from the File menu.

2. Wait for the end of the operation before performing any
other function.

Delete the archive

1. Select Initialize Archive from the File menu.

2. Wait for the end of the operation before performing any
other function.

Backup and restore

It is strongly recommended to backup files, a warning message
will be displayed monthly. This function allows the user to
restore the data if the PC or the HD will not work anymore.

Backup

1. Select Backup archive from the File menu.

2. Selecting the destination path with the Browse key or press
New to create a new directory. Press OK to confirm.

Chapter 5 - Database Management - 41

3. In the dialog box it will appear an estimate of the number of
floppy you need in order to back up the archives. Press OK.

Restore

1. Select Restore archive from the File menu.

2. On the Restore dialog box specify the drive source and press
OK, a dialog box will appear indicating all data of the
backup processed.

42 - SpirHOMEter User Manual

Spirometry

Setting spirometry options

The software allows to configure some options selecting
Configure from the Option menu.

Spirometry

Automatic Interpretation

The SpirHOMEter has the function of interpreting each test
performed by a patient visualising an automatic diagnosis. The
algorithm has been calculated basing on “Lung Function Testing:
selection of reference values and interpretative strategies,
A.R.R.D. 144/ 1991:1202-1218”. The automatic diagnosis is
calculated at the end of the FVC if:

• the automatic diagnosis option is enabled.

• the patient’s anthropometric data allow the calculation of the

LLN (Lower Limit of Normal range).

• at least one FVC test has been performed.

To enable/disable the automatic diagnosis:

1. Click on Enable Automatic Interpretation.

2. Select the LLN (Lower Limit of Normal Range) criteria
among the ATS (LLN=Pred-0.674*SD), ERS (LLN=Pred-

1.647*SD) or 80%Pred (LLN=Pred*0.8) specifications.

44 - SpirHOMEter User Manual

Quality control

The SpirHOMEter allows a quality test control. The calculation
has been carried out referring to “Spirometry in the Lung Health
Study: Methods and Quality Control, A.R.R.D. 1991; 143:1215­1223”. The messages concerning the quality control are shown at
the end of the test.

To enable/disable the quality control, click on Enable Quality
Control checkbox.

Parameters manager

The program allows to calculate a huge number of parameters; it
is advisable, in order to simplify the analysis of the results, to
view, to print and to sort the desired parameters only. Select the
menu item Options/Parameters...

View

Move the parameters to view into the Selected parameters list.

Print

Move the parameters to print into the Selected parameters list.

Sort

Drag the parameter up or down with the mouse.

Customise

Add, modify and delete custom parameters.

If it is necessary to restore the default parameters press the button
in the left corner of the window to initialise the parameters
database.

Chapter 6 - Spirometry - 45

Predicted values manager

The program contains a preset of predicted equations, but the
user is allowed to customise its own predicted sets. Select
Predicteds... from Options menu.

The window is divided into two forms: Predicteds set and
Formula definition.

Predicteds set

This form allows the user to manage the set of predicteds. The
following information define a set:

Name: identifies the set and cannot be duplicated;

Description: free field;

Age: the adult predicteds start since this age.

To enter a new set of predicteds click on the New button. The
field Name must be filled and must be unique. To stop without
saving click on the Cancel button. To save the set, click on the
Save button.

To delete a set of predicteds click on the Delete button. If a set is
deleted, also the associated formulae are deleted.

It is possible to generate a new set of predicteds with the same
attributes and the same formulae of the selected one. To do this
click on the Copy... button and specify a new Name.

To import a set of predicteds click on the Import... button and
select a file of Predicteds files type.

To export a set of predicteds click on the Export... button.

46 - SpirHOMEter User Manual

In the list Set current predicteds choose the current predicteds
for printing and viewing.

Set the current predicted

The SpirHOMEter allows to calculate the predicted values
according to the following configurable sets:

Adults Paediatrics

ERS 93 Zapletal

Knudson83 Knudson83

ITS white ITS white

ITS black ITS black

LAM LAM

MC Barcelona MC Barcelona

Nhanes III Nhanes III

Select the desired choice in the group Predicted.

Formula definition

This form allows the user to manage the formulae associated to a
set of predicteds.

Select the set of predicteds from the list Predicteds set.

To insert a new parameter click on the New... button.

The parameter formulae can be:

• calculated according to the predicteds in the list Use the
predicteds formulae;

Chapter 6 - Spirometry - 47

Page set-up

• customised by the user with the option ...or the customised
formulae.

The Delete button deletes the selected parameter.

The Copy button stores the selected parameter in memory.

The Paste button inserts a new parameter from the one copied. If
the name is not unique, the user is asked whether to specify a
new name or to replace the existing parameter.

Select Page Setup... from the File menu.

Header All the printouts carried out by the

program are preceded by 3 rows of
customisable header (usually they contain
the name and the address of the Hospital
using the spirometer).

Data Patient and visit information are printed

below the header. These data are reported
on 3 columns and 5 rows. the user may
configure the disposition, change and
eventually cancel the fields, as he prefers.

Margins Configures the print margins from the

borders of the paper. The unit of measure
is decided in Units of measurements.

Footer Configures information at the bottom of

the page.

48 - SpirHOMEter User Manual

Printed file name Defines the automatic name to be

asssigned to the pdf file, if the report will
be printed in this format.

In the example it has been set to create a

filename composed by <date of the test>
followed by <last name> and <first
name>.

Chapter 6 - Spirometry - 49

Spirometry tests

Tips for correct use of the device



Note: Read
carefully the
contraindications
in Chapter 1.

Keyboard

Before the SpirHOMEter is delivered to the patient, we would
advise that he/she receive a short course in use of the instrument
and correct performance of the FVC test.

In order to reach a clearer diagnosis and/or check the
effectiveness of the treatment being administered, it is always
advisable to record the severity of the symptom before the test,
by pressing the reative keys

For the sake of ease, we shall refer to the SpirHOMEter keys
with the numbers they represent on the keyboard:

Key 0.

Key 1.

Key 2.

Key 3.

Drugs

In order to analyze the state of the lung function also as a
function of the treatment being received, it is possible to record
the time at which the drug is taken. The SpirHOMEter records
the date and the time at which one or more drugs (up to a
maximum of 4) are taken.

After switching on, the date and the time appear on the display
panel, followed by this message:

Press 0 for NO, press 1, 2 or 3 for YES.

If YES, the device scrolls through the list of drugs to be taken.

50 - SpirHOMEter User Manual

Do you want to

enter drugs ?

Drug A?

Press 0 to indicate that the drug was not taken, otherwise press 1,
2 or 3 to confirm.

When the stage has been completed, the following message is
displayed:

Carry out

test ?

Press 0 to terminate the session, press 1, 2 or 3 to perform the
test.

Recording the severity of symptoms

If the previous question has been answered affirmatively, the list
of symptoms appears. The first is COUGH

Cough ?

Give the severity of the symptom (which will be recorded) by
pressing 0 (absent), 1 (slight), 2 (medium), 3 (severe).

Immediately after this, the symptoms DYSPNEA, MUCUS and
WHEEZING will appear in order. Repeat the operations
described for COUGH.

When this phase has been completed, the following message will
appears:

Carry out

test no.1

Performing the test

The Forced Vital Capacity (FVC) test can also be performed by
taking a few normal breaths before step 4 (breathing in fully).

For hygienic reasons, we strongly recommend the use of a
bacterial filter.

1. Fit the mouthpiece or the bacterial filter to the device

2. Apply the noseclip

3. Take the mouthpiece tightly between lips and breathe
normally

4. Breathe in fully

5. Breathe out as quickly and long as possible

6. At the end of the test some of the values obtained will appear
on the display.

Chapter 6 - Spirometry - 51

When the first test is complete, carry out the second, and then a
third if the device requires it.

Note: If the tests are not carried out correctly, the following
error message will appear, and in this case the test session must
be repeated.

Test finished

incorrectly

52 - SpirHOMEter User Manual

Viewing results

All the visualisation functions refer to the test carried out by the
Current Patient, whose name is indicated on the left-side of the
status bar.

To view tests results:

1. Select the Patients from the File menu

2. Select the patient corresponding to the test you want to view.

3. Select in the list box of the tests up to 5 tests of the kind
(FVC, VC/IVC, or MVV) and press OK.

To switch between graph and or data use the following buttons
on the toolbar:

view Flow Volume graph (F5)

view Volume Time graph (F6)

view data of the test (F7)

If you need more than one visualisation meantime use the New
Window function from the Window menu.

If you need to display a list of visits:

• Select Visits list... from the File menu.

• Type the name of the Company and/or the time interval

desired or simply confirm for the complete list.

Tests of the current patient

If a current patient has been selected you can quickly view his
tests selecting Test current patient... from the View menu.

Delete a test

1. Select Patients from the File menu or press the button by
side.

2. Select the test that you want to eliminate from the list of the
tests referred to the Current Patient and press Delete.

Chapter 6 - Spirometry - 53

View a trend

It is possible to analize the trend of measured parameters (FVC,
FEV1, etc.) graphing the values, with reference to the symptoms
and to the drugs taken.

1. Select Trend... from View menu.

2. It will be open a window in which are displayed all the tests
linked to the current patient.Select the test you want view the
trend, following the instructions on the window.

3. In the lower part of the window, select the parameters to
graph. For each trend graph, you can choose if it will be
graphed a measured parameter and its predicted value or two
different measured parameters.

4. Press OK to confirm.

A window will appear, divided into two sections: in the upper
section you can see the measured parameters of all the tests, in
the lower part, the trend graphs. On the graphs will be pointed

54 - SpirHOMEter User Manual

out when the patient had taken the drugs; below the graphs, for
each time, it is shown the severity of the symptoms.

You can choose to view, in the lower part of the window, the
trend graphs or the measured values, from the View menu.

Chapter 6 - Spirometry - 55

Printing results

You can print out in three different ways:

• printing the Report

• printing the Active Window

Printing Reports

To print a report of the current visit, select Print report… from
File menu. In the dialog box, select the visit you want to print the

report.

The software will choose automatically the best performed test (if
more than 1 test was performed).

• Selecting the option One page (no ATS) the report will
contain, on one page, the F/V and V/t graphs of the best test,
overlapped on the FVC Post, the patient data, the notes, the
diagnosis and the test results.

• Otherwise the report will contain two pages, the first with
the patient data, the graphs and the diagnosis, and the second
one with the measured parameters, according to the ATS
recommendations.

Select the desired options:

FVC graph Prints the F/V and V/t curves for the best

One page (no ATS) Prints data and graphs on the first page.

Preview Views a report preview on the screen.

FVC test.

Printing the active window

This active window printout function is only enabled when the
active window (title bar highlighted) is one of the following
objects:

• Any kind of Graph.

• Numeric data

• List of visit

To print the active window select Print Active window from
File menu.

56 - SpirHOMEter User Manual

Printing a series of reports

Sometimes it is useful to printout automatically a series of reports
(all tests carried out with the employees, all tests carried out in
the today's session).

To print out proceed as follows:

1. Select Visit List from the File menu

2. Set the criteria of the visits to be added in the list (from,
to,...)

3. Select Print Report from the File menu.

Electronic reports (*.pdf)

If an Adobe PDF writer “Printer Driver” is installed and set as
the default printer, it is possible to store the printout report
automatically in any location of the HD or eventually LAN paths
according to a customizable filename format.

It is possible to define the created filename format selecting
File/Page Set up... (see Page set-up).

Export data

With this function you can export the test data in 4 different
formats:

• *.txt (ASCII)

• *.xls (Microsoft Excel)

• *.wk1 (Lotus 123)

• *.xpo (Cosmed)

Export a test

1. Select Export tests from the File menu.

2. Select the test to export from the list box and press OK.

3. Type the name and the format of the file in the dialog Save
as. If the ASCII format is selected, the Text button in the
dialog box Save as allows you to configure the separators for
character based files.

With the *.xpo Cosmed file format it is possible to import

data from another Quark archive. Press OK to confirm.

4. Select the folder for the export and type the file name. Press
OK to confirm. A status bar will show the file creation.

Chapter 6 - Spirometry - 57

58 - SpirHOMEter User Manual

System

maintenance

System maintenance

All service operations which are not specified in this user manual
should be performed by qualified personnel in accordance with
the service handbook (to be required to the manufacturer).

All materials used in the construction of the SpirHOMEter are
non toxic and pose no safety risk to the patient or operator.

Prior to the device cleaning, disinfection and inspection it is
necessary to switch off the device and to disconnect adapters
from the supply mains.

In order to guarantee the highest accuracy of measurements we
recommend you to disinfect the turbine periodically.

Cleaning and disinfection

Cleaning and disinfecting instructions are of fundamental
importance to control infections and assure patient safety. In fact
aspiration of residue, particles and contaminated agents are life –
threatening.

In this handbook we strongly recommend you to follow the rules
worked out by ATS and ERS (see: ”Lung Volume Equipment
and Infection Control” – ERS/ATS WORKSHOP REPORT
SERIES, European Respiratory Journal 1997; 10: 1928 – 1932),
which are summarised and adapted for COSMED products as
follows:

• Accessible internal as well as external surfaces of equipment
exposed to expired gas should be washed and disinfected
prior to testing of subsequent patients.

• Disinfecting should ideally be performed by heat
sterilisation, but gas or liquid sterilisation can be used if the
equipment is well cleaned first (no droplets of saliva/sputum
remain).

• Disposable gloves should be worn when handling
mouthpieces, when cleaning equipment exposed to saliva or
sputum and especially when drawing blood.

• Laboratory staff should wash hands prior to testing of each
patient.

• Adopt particular precautions when testing patients with
recognised high – risk communicable diseases (e.g.
tuberculosis, multidrug – resistant staphylococcus). In these

60 - SpirHOMEter User Manual

cases, the clinical need for such testing should justify the
risks.

During the disinfection:

• do not use alcohol or other liquids containing gluteraldehyde
on the exterior surfaces of the equipment. Actually they can
damage polycarbonates plastics and may produce unhealthy
substances.

• do not use abrasive powders or glass cleaners containing
alcohol or ammonia on the plexiglas components of the
equipment

• do not steam autoclave any parts of the equipment unless it
is clearly specified.

• do not immerse the optoelectronic reader.



Warning: Do not
use alcoholic
solutions for the
turbine,
otherwise there
can be damages
to the plastic
material.

Cleaning the turbine flowmeter

It is necessary to disinfect periodically the turbine for sanitary
measures or/and for the correct device function.

As disinfecting solution it is suggested Sodium hypochlorite 5%
(bleach).

The disinfecting procedure is easy and may be effected every
time the user needs, keeping attention to some precautions:

1. Take out the turbine.

2. Dip it in a disinfectant solution (non alcoholic based) for
about 1 hour.

3. Rinse the turbine in a vessel, filled of clean water, shaking
gently to remove the disinfectant (do not clean the turbine by
putting it under running water!).

4. Let it dry to air.

5. After cleaning the turbine, check if the turbine propeller
rotates freely even with a low speed air flow.

6. Connect the turbine to the reader.

Precautions during the cleaning of the turbine

1. Do not expose the turbine to high heat and do not put it
under running water.

2. Do not ever dip the optoelectronic reader in any kind of
solution, the liquid infiltration would damage the internal
circuit.

3. Do not use alcoholic solutions to clean the turbine.

Chapter 7 - System maintenance - 61

Inspections

Suggested disinfection solutions

Helipur H Plus Braun Melsungen AG

Gigasept FF Schulke & Mayr GmbH

Dismozon pur Bode Chemie GmbH

TETA-S Fresenius AG

CIDEX Johnson & Johnson

The equipment requires easy inspections to be carried out in
order to assure a proper electrical and mechanical safety level in
the years.

These inspections are highly recommended after a rough use of
the equipment or after a period of storage in unfavourable
environmental conditions.

Referring to the electrical safety, it is important to check the
conditions of insulation materials of cables, plugs and any other
visible part by means of simple inspection, when the equipment
is switched off and disconnected from the supply mains.

Extract the turbine from the unit and verify, by inspection, that
the turbine axis fits correctly its seats and the blade is strongly
fastened on the axis itself (it can be useful to shake slightly the
turbine in order to note any anomalous movement).

Check if there are any torn or broken components in the
breathing circuits: remember that they can create safety risk to
patients during tests.

Replace the batteries



Note: Do not
replace the
battery if you
don’t have the
new ones
ready. If the
SpirHOMEter is
left without
batteries, it
retains stored
data only for
few minutes.

62 - SpirHOMEter User Manual

Replace the batteries when the following message appears:

The SpirHOMEter uses 4 AAA-size 1,5 Volt vatteries.

1. Check that you have the new batteries ready.

2. The on-off switch must be set to 0.

3. Remove the cover of the battery compartment.

4. Remove the old batteries.

5. Insert the new ones as indicated on the back of the device.

6. Close the battery compartment by sliding the cover along the
slots.

LOW

BATTERIES

Appendix

Service - Warranty

Warranty and limitation of liability

COSMED provides a one (1) year limited warranty from the date
of the original sale of COSMED products. All COSMED
products are guaranteed to be free from defect upon shipment.
COSMED’s liability for products covered by this warranty is
limited exclusively to replacement, repair, or issuance of a credit
for the cost of a defective product, at the sole discretion of
COSMED. COSMED shall not be liable under the foregoing
warranty unless (i) COSMED is promptly notified in writing by
Buyer upon discovery of defect; (ii) the defective product is
returned to COSMED, transportation charges prepaid by Buyer,
(iii) the defective product is received by COSMED no later than
four weeks after the last day of the one (1) year limited warranty
period; and (iv) COSMED’s examination of the defective product
establishes, to COSMED’s exclusive satisfaction, that such defect
was not caused by misuse, neglect, improper installation,
unauthorised repair or alteration, or accident. If the product is
manufactured by a third-party, COSMED shall make available
for the Buyer’s benefit only those warranties which COSMED
has received from the third-party manufacturer(s). COSMED
hereby specifically disclaims any and all warranties and/or
liabilities arising from defect(s) and/or damage(s) to and/or
caused by products manufactured by third-party manufacturers.
Buyer must obtain written authorisation from COSMED prior to
the repair or alteration of COSMED products(s). Failure of
Buyer to obtain such written authorisation shall void this
warranty.

COSMED hereby specifically disclaims any and all other
warranties of any kind, whether express or implied, in fact or by
law, including, but without limitation, any and all warranties of
merchantability and/or fitness for a particular purpose.

COSMED shall not be liable for special, indirect and/or
consequential damages, nor for damages of any kind arising from
the use of any COSMED’s products, whether said products are
used alone or in combination with other products or substances.

Determination of the suitability of any of COSMED’s product(s)
furnished hereunder for the use contemplated by Buyer is the sole
risk and responsibility of Buyer, and COSMED has no
responsibility in connection therewith. Buyer assumes all risks

64 - SpirHOMEter User Manual

and liabilities for loss, damage or injury to persons or property of
Buyer or others arising out of the use or possession of
COSMED’s products.

The limited warranty as herein above set forth shall not be
enlarged, diminished, modified or affected by, and no obligation
or liability shall arise or grow out of, the renderings of technical
advice or service by COSMED, its agents or employees in
connection with Buyer’s order or use of the product(s) furnished
hereunder.

Return goods policy for warranty or non warranty repair

Goods shipped to COSMED for repair are subject to the
following conditions:

1. Goods may only be returned after your receipt of a Service
Return Number (SRN) from COSMED S.r.l.

2. Place your SRN report and Packing List outside the package.

3. Goods returned must be shipped with freight and insurance
charges prepaid. Collect shipments will not be accepted.

4. The following list of goods are not eligible for return unless
proven defective.

- Special order items

- Expendable products

- Goods held over 30 days from COSMED’s invoice date.

- Used goods not in original shipping containers.

- Goods which have been altered or abused in any way.

5. The following parts are not covered by warranty:

- consumables

- fragile glass or plastic parts

- rechargeable batteries

- damages due to use of the device not conforming to the
indication reported in this manual

Repair Service Policy

Goods returned to seller for Non-Warranty repair will be subject
to conditions 1, 2, 3, 4.

The returned goods need to re-enter COSMED together with the
customs documents (Pro-forma Invoice and Customs Paper) as
requested by the Italian law.

• The shipment has to be qualified as a Temporary Export.

Chapter 8 - Appendix - 65

• All the goods returned to COSMED without the customs
papers will not be accepted.

For European Community members:

Pro-Forma invoice complete with:

• Number

• Description of the goods

• Quantity

• Serial Number

• Value in €

• Number of parcel

• Gross weight

• Net weight

• Reason for resent (i.e. Resent for repair)

In case you should send the system for repair please contact the
nearest service centre or contact COSMED at the following
address:

COSMED S.r.l.

Via dei Piani di Monte Savello 37
P.O. Box 3
00040 Pavona di Albano - Rome, Italy
tel. [phone]
fax [phone]
E-mail: [e-mail]

For USA customers only please contact:

COSMED USA Inc

1808 North Halsted Street
Chicago, IL 60614 USA
Phone: [phone]
Fax: [phone]
email: [e-mail]

To ensure that you receive efficient technical assistance, please
specify as precisely as possible the nature of the problem as it is
specified on the assistance information form.

We advise you to save the original packaging. You may need it in
case to ship the unit to a technical assistance centre.

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Privacy Information

Dear Customer,

we inform you that your personal data are gathered and will be
used by Cosmed Srl in conformity with the requirements of the
Italian privacy law (Decreto Legislativo 196/2003). We believe it
is important for you to know how we treat your personal data.

Personal data treatment and purposes

We request and process your personal data:

a. to place an order, register a product, request a service,

answer a survey, enter a contest, correspond with us (all of
the above, in the following: “service”) and, if necessary, to
supply the Competent Authorities with the required
information;

b. in order to define your commercial profile;

c. in order to use your commercial profile for own marketing

and advertising purposes;

d. for accounting purposes, including e-mailing of commercial

invoices;

e. for providing your information to selected business partners

(also abroad), in order to supply the service;

How your personal data are treated

Your personal data will be stored in electronic format, and
protected at the best from destruction, loss (even accidental), not
authorized accesses, not allowed treatment or use not in
conformity with the purposes above listed.

The consent is optional, but…

If you deny the consent, we regret we cannot supply the service.

Holder of the treatment

The holder of the treatment is Cosmed Srl, Via dei Piani di
Monte Savello 37, Pavona di Albano Laziale (RM). The
responsible of the personal data treatment is indicated in the
documentation stored by Cosmed Srl itself.

Chapter 8 - Appendix - 67

Customer rights

In accordance with art.7 of the Law, you can:

a. obtain confirmation of the existence of your personal data

b. obtain:

c. deny your consent to the treatment of your personal data;

These rights can be exercised directly requesting in writing to the
holder of the treatment.

and their communication in intelligible form;

• updating, correction or integration of your data;

• deletion or transformation in anonymous form of your

personal data;

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ATS 94 recommendations

Reference: “Standardization of Spirometry: 1994 Update”
“American J. Respiratory Critical Care Medicine”, Vol. 152,
1107-1136; 1995.

ATS recommendations

Volume range: 8l (BTPS)

Flow range: ±14 l/sec

Volume accuracy: ±3% or < 50ml

Flow accuracy: ±5% or < 200ml/sec

Flowmeter resistance: <1.5 cmH2O da 0 a 14 l/sec

Reproducibility: the 2 largest of 3 acceptable FEV1 and FVC
values should be within 5% or 150 ml.

The end of test: no change in volume for 1 second with at least 6
seconds of collected volume.

Accumulation time: the maximum time allowed for volume
accumulation during the VC manoeuvre should be at least 30
seconds and at least 15 seconds during the FVC.

The spirometer should be store at least 8 FVC maneuvres.

FEV1 should be calculated by using the “back extrapolation”
method to detect the start of the test, extrapolated volume must
not be higher then 5% FVC or 150ml.

The graphic resolution of the printed report must be as in the
following:

Volume: 10 mm/l

Flow: 5 mm/l/sec

Time: 20 mm/sec

F/V ratio: 2:1

The total number of error (FVC e FEV1 >±3.5%, FEF25-75%
>5.5%) during the measurement of the 24 standard waveforms
must be lower than 4.

Chapter 8 - Appendix - 69

Predicted values

ERS93

Reference Adult:

Standardized Lung Function Testing: Official Statement of the
European Respiratory Society, The European Respiratory Journal
Volume 6, Supplement 16, March 1993.

Reference Paediatric:

Compilation of reference values for lung function measurements
in children: Ph. H. Quanjer, J. Stocks, G.Polgar, M. Wise, J.
Karlberg, G. Borsboom; ERJ 1989, 2, Supp.4,184s-261s.

KNUDSON 83

Reference Adult/ Paediatric:

Changes in the Normal Maximal Expiratory Flow-Volume Curve
with Growth and Anging: J. Knudson, D. Lebowitz, J. Holdberg,
B. Burrows; ARRD 1983; 127:725-734

Note: SD@FEV1/FVC e FEV1/VC da ERS93

ITS (White race)

Reference Adult/ Paediatric:

Intermountain Thoracic Society: Clinical Pulmonary Function
Testing, second edition (1984) pp 101, 144

Note: SD@FEV1/FVC e FEV1/VC da ERS93

ITS (Black race)

Reference Adult/ Paediatric:

Intermountain Thoracic Society: Clinical Pulmonary Function
Testing, second edition (1984) pp 101, 144

Note: SD@FEV1/FVC e FEV1/VC da ERS93

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LAM

Reference Adult/ Paediatric:

A survey of ventilatory capacity in Chinese subjects in Hong
Kong: Lam Kwok-Kwong, Pang Shing et Al. Annals of Human
Biology, 1982, vol. 9, No. 5, 459-472.

Note: SD@FEV1/FVC e FEV1/VC da ERS93

Multicéntrico de Barcelona

Reference Adult/ Paediatric:

Spirometric reference values from a Mediterranean population: J.
Roca, J. Sanchis, A. Agusti-Vidal, F. Segarra, D. Navajas. R.
Rodriguez-Roisin, P. Casan, S. Sans. Bull. Eur. Physiopathol.
Respir. 1986, 22, 217-224.

NHANES III

Reference Adult/ Paediatric:

Spirometric reference values from a sample of the general US
population: John L. Hankinson, John. R. Odencrantz and
Kathleen B. Fedan. Am J Respir Critr Care Med 1999, 159,
1798-187.

Automatic diagnosis (algorithm)

Reference: “Lung Function Testing: selection of reference
values and interpretative strategies”, A.R.R.D., 144/ 1991:1202-

1218.

LLN=Pred-0.674*SD (ATS, 50° percentile)

LLN=Pred-1.647*SD (ERS, 95° percentile)

LLN=Pred*0.8 (80%Pred)

Message interpretation Criterion

Normal Spirometry FVC and FEV1/FVC > LLN

Obstructive abnormality
(it may be physiological) % Pred FEV1 >= 100

Obstructive abn.: mild % Pred FEV1 < 100 and >= 70

Obstructive abn.: moderate % Pred FEV1 < 70 and >= 60

Obstructive abn.: mod. severe % Pred FEV1 < 60 and >= 50

Chapter 8 - Appendix - 71

Obstructive abn.: severe % Pred FEV1 < 50 and >= 34

Obstructive abn.: very severe % Pred FEV1 < 34

Restrictive abn.: mild FVC<LLN and %Pred FVC>=70

Restrictive abn.: moderate % Pred FVC < 70 and >= 60

Restrictive abn.: mod. severe % Pred FVC < 60 and >= 50

Restrictive abn.: severe % Pred FVC < 50 and >= 34

Restrictive abn.: very severe % Pred FVC < 34

Quality Control Messages

Reference: Spirometry in the Lung Health Study: Methods and
Quality Control, ARRD 1991; 143:1215-1223.

Message Criterion

Start faster VEXT >5% of the FVC and >150ml

Blast out harder PEFT >120 msec

Avoid coughing 50% drop in the flow in first second

Blow out longer FET100% <6 sec.

Blow out more air flow >0.2l/s within 20 ml of FVC

Blow out harder dPEF<10%

Take a deeper breath dFVC<200ml and 5% best FVC

Blow out faster dFEV1<200ml and 5% FEV1

That was a good test No errors

FVC reproducible diff. 2 max FVC within 0.2 l

FEV1 reproducible diff. 2 max FEV1 within 0.2 l

PEF reproducible diff. 2 max PEF within 10 %

MVV time too short MVV time less than 12 sec

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References

ATS ’94: “Standardization of Spirometry: 1994 Update”,
American J. Respiratory Critical Care Medicine, Vol. 152, 1107­1136; 1995

ERS ’93: “Standardized Lung Function Testing: Official
Statement of the European Respiratory Society”, The European
Respiratory Journal Volume 6, Supplement 16, March ”

“Standardization of Spirometry: 1987 Update”, American
Review of Respiratory Disease, Vol. 136, 1285-1289; 1987

Lung function", J.E. Cotes, Blackwell scientific publications

"Guidelines for Clinical Exercises Testing Laboratories", I.L.
Pina, G.J. Balady, P. Hanson, A.J. Labovitz, D.W. Madonna, J.
Myers. American Heart Association. 1995; 91, 912.

“Office spirometry”, R.E. Hyatt - P.L. Enright, Lea & Febiger

Chapter 8 - Appendix - 73

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