Cosmed SpirHOMEter Spirometer - Service 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.
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Lotus 123 is a registered trademark of Lotus Development Corporation .
SpirHOMEter User manual, V Edition

10/2004
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

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
Preparing the disinfecting solution................................................. 61
Cleaning the turbine flowmeter ...................................................... 61
Precautions during the cleaning of the turbine ............................... 62
Suggested disinfection solutions .................................................... 62
Inspections............................................................................................ 62
Replace the batteries............................................................................. 63
Appendix 65
Service - Warranty.................................................................66
Warranty and limitation of liability ...................................................... 66
Return goods policy for warranty or non warranty repair..................... 67
Repair Service Policy ........................................................................... 67
Privacy Information ...............................................................69
Personal data treatment and purposes................................................... 69
How your personal data are treated ...................................................... 69
The consent is optional, but….............................................................. 69
Holder of the treatment......................................................................... 69
Customer rights .................................................................................... 70
ATS 94 recommendations......................................................71
ATS recommendations ......................................................................... 71
Predicted values ....................................................................72
Automatic diagnosis (algorithm) .......................................................... 74
Quality Control Messages .................................................................... 75
References..............................................................................76
Index - 5
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:

• 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. Use disposable anti-bacterial
filters or disinfect each part in contact with the patient before
each test.
5. You must follow all the cleaning procedures in System
Maintenance, and you must thoroughly inspect the
components after cleaning and before each patient test.
6. 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).
7. Keep the device away from heat and flame source,
flammable or inflammable liquids or gases and explosive
atmospheres.
8. 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

9. It is recommended to use a computer with electromagnetic
compatibility CE marking and with low radiation emission
displays.
10. It is necessary to make the PC, connected to the
SpirHOMEter, compliant with EN 60601-1 by means of an
isolation transformer.
11. 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

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 3rd month.

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.

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 EN ISO 9001:2000 (Registration n° 387-A Cermet)
Medical Device Directive (CE mark)

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

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.

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

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: +39 (06) 931.4580
email: customersupport@cosmed.it
Internet: http: //www.cosmed.it
Complain, feedback and suggestions

If you have any complain, feedback information or suggestion,
please inform us at complain@cosmed.it.

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

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

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
FEV1/FEV6 % FEV1 as a percentage of FEV6
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
FEF25-75% l/sec Mid-exp flow between 25-75%FVC
FET100% sec Forced expiratory time
FEV1/VC% % Tiffenau index
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%)

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.

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.
2.Calib 3.Config
1.Trans 0.Cancel
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.

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:
Insert
secret code
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:
MEMORY EMPTY
(Press any key)
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.
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.
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):
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:
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.

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

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.
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
the end of the scroll bars
• To move the scroll bar page by page click on the grey area at
both sides of the scroll fields
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.

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.
2.New K=128
1.Standard 0.Esc
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 Meas %Corr
3.00 3.32 -9.7
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:
2.Cancel New
1.Store K=089
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).
Note: If a bacterial filter is used for the tests, do use it also

during the turbine calibration.

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).

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

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.
Patient Card
Note: after having
deleted a record
It collects all the information of a patient (first name, last name,
(patient, visit or date of birth) which remain the same for each visit. For each
test), it is patient there is only one Patient Card, which is created the first
recommended to time the Patient performs a test.
reorganize the
archive in order to To move within the database use the following buttons:
free disk space.
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

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.

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.

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

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
the current test to link.
Link Link the current test to the current patient.

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.

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.

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.

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; 143:1215-
1223”. 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.

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;
• 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.
Page set-up
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.

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>.
Spirometry tests
Tips for correct use of the device

Before the SpirHOMEter is delivered to the patient, we would
Note: Read advise that he/she receive a short course in use of the instrument
carefully the and correct performance of the FVC test.
contraindications
in Chapter 1. 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
Keyboard
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:
Do you want to
enter drugs ?
Press 0 for NO, press 1, 2 or 3 for YES.
If YES, the device scrolls through the list of drugs to be taken.
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.
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

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.
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

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.
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
FVC test.
One page (no ATS) Prints data and graphs on the first page.
Preview Views a report preview on the screen.
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.

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.
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.
Use disposable anti-bacterial filters or disinfect each part in
contact with the patient before each test.
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 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.
• Liquid disinfection 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
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.
Preparing the disinfecting solution

The following recommendations are retrieved from:
APIC (Association for Professionals in Infection Control and
Epidemiology, Inc.): APIC Guidelines for Selection and Use of
Disinfectants; William A. Rutala, PhD, MPH, CIC. American
Journal of Infection Control, vol.24, N.4, pp. 313-342, August
1996 - http://www.apic.org/pdf/gddisinf.pdf
As disinfecting solution it is suggested:
• Sodium hypochlorite 0.5% (5000 ppm) prepared fresh for
use within 24 hours.
• Sodium hypochlorite 1% (10000 ppm) prepared fresh for use
within 30 days.
The first solution can be easily prepared by adding 1 part
household bleach (sodium hypochlorite 5.25%) to 9 parts water,
the second one by adding 1 part household bleach to 4 parts
water.
Cleaning the turbine flowmeter

Warning: Do not
It is necessary to disinfect periodically the turbine for sanitary
use alcoholic
solutions for the measures or/and for the correct device function.
turbine, 1. Take out the turbine.
otherwise there
can be damages 2. Dip it in a disinfectant solution (non alcoholic based) for
to the plastic about 20 minutes.
material.
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.
Chapter 7 - System maintenance - 61

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.
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
Inspections
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
Replace the batteries when the following message appears:
Note: Do not LOW
replace the
battery if you BATTERIES
don’t have the
new ones The SpirHOMEter uses 4 AAA-size 1,5 Volt vatteries.
ready. If the 1. Check that you have the new batteries ready.
SpirHOMEter is
left without 2. The on-off switch must be set to 0.
batteries, it 3. Remove the cover of the battery compartment.
retains stored
data only for 4. Remove the old batteries.
few minutes.
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.
Chapter 7 - System maintenance - 63

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

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 - 67
• 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. +39 (06) 9315492
fax +39 (06) 9314580
E-mail: customersupport@cosmed.it
For USA customers only please contact:
COSMED USA Inc
2758 North Paulina
Chicago IL 60614 USA
Phone: +1 (773) 528-8113
Fax: +1 (773) 528-8116
email: usa.sales@cosmed.it
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.

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.
Customer rights
In accordance with art.7 of the Law, you can:
a. obtain confirmation of the existence of your personal data
and their communication in intelligible form;
b. obtain:
• updating, correction or integration of your data;
• deletion or transformation in anonymous form of your
personal data;
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.

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.
Predicted values
ERS93
Standardized Lung Function Testing: Official Statement of the
European Respiratory Society, The European Respiratory Journal
Volume 6, Supplement 16, March 1993.
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
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
ITS
Intermountain Thoracic Society: Clinical Pulmonary Function
Testing, second edition (1984) pp 101, 144
LAM
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.
Multicéntrico de Barcelona
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
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.
Pneumobil (Brazil)
Valores extraìdos do Programa Pneumobil/Brasil para a Tese de
Doutoramento do Dr. Carlos Alberto de Castro Pereira.
(Boehringer).
Gutierrez (Chile)
Gutierrez et Al. Reference values for Chile population
Knudson, Morris and Bass
The maximal Expiratory Flow-Volume curve: Knudson et al.
ARRD Vol. 123, p. 659-664, 1981

Spirometric Standard for healthy non-smoking adults: ARRD
Vol. 10-3, p. 57-67, 1971
Pereira (Brazil)
Pereira CAC; Barreto SP; Simões JG; Pereira FWL; Gerstler JG;
Nakatani J. Valores de Referência para Espirometria em uma
amostra da população brasileira adulta. Jornal de Pneumologia
1992; 18: 10-22.
Mallozi MC. Valores de referência para espirometria em crianças
e adolescentes, calculados a partir de uma amostra da cidade de
São Paulo. Valores finais publicados em : Pereira CAC; Lemle
A; Algranti E; Jansen JM; Valença LM; Nery LE; Mallozi M;
Gerbasi M; Dias RM; Zim W. I Consenso Brasileiro sobre
Espirometria. Jornal de Pneumologia 1996; 22:105-164.
Scalambrini Costa F, Scueiri CEB, Silva Jr WC, Pereira CAC,
Nakatani J. Valores de referência para espirometria em uma
amostra da população brasileira adulta da raça negra. J
Pneumologia 1996;22: 165-170.
Neder JA; Andreoni S; Castelo-Filho A; Nery LE. Reference
values for lung function tests. I. Static Volumes. Brazilian
Journal Medical and Biological Research 1999; 32:703-17.
Neder JA, Andreoni S, Lerario MC, Nery LE. Reference values
for lung function tests. II. Maximal respiratory pressures and
voluntary ventilation. Braz J Med Biol Res 1999 ;32:719-27
DLCO
Standardized Lung Function Testing: Official Statement of the
European Respiratory Society, The European Respiratory Journal
Volume 6, Supplement 16, March 1993.
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.
Reference Values for Residual Volume, Functional Residual
Capacity and Total Lung Capacity - ATS workshop on Lung
Volume measurements, official statement of the European
Respiratory Society; J. Stocks, Ph. H. Quanjer: ERJ, 1995, 8,
492-506
Single Breath Oxygen Test
Buist SA, Ross BB: Quantitative Analysis of the Alveolar
Plateau in the Diagnosis of Early Airway Obstruction. ARRD
108: 1081, 1973
Mansell A, Bryan C, Levison H: Airway Closure in Children.
JAP 33: 711-714, 1972
Buist SA, Ross BB: Predicted Values for Closing Volumes Using
a Modified Single Breath Test. ARRD 107: 744-751, 1973.
Rint
Lombardi E, Sly PD, Concutelli G, et al. Reference values of
interrupter respiratory resistance in healthy preschool white
children. Thorax 2001; 56: 691-695.
Mip/Mep
Leo F. Black, Robert E. Hyatt: Maximal Respiratory Pressures:
Normal Values and Relationship to Age and Sex, American
Review of Respiratory Disease, Volume 99, 1969
Vincken W, Ghezzo H & Cosio MG (1987). Maximal static
respiratory pressures in adults: normal values and their
relationship to determinants of respiratory function. Bull Eur
Physiopathol Resp 23: 435-439.
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
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
References
ATS ’94: “Standardization of Spirometry: 1994 Update”,
American J. Respiratory Critical Care Medicine, Vol. 152, 1107-
1136; 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

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documentation or for casual or consequential damages in connection with the

SpirHOMEter User manual, V Edition

COSMED Srl - Italy

2 - SpirHOMEter User Manual

4 - SpirHOMEter User Manual

8 - SpirHOMEter User Manual

Chapter 1 - Getting started - 9

Equipment type B (EN60601-1)

Danger: high temperature

Protective earth ground

10 - SpirHOMEter User Manual

Chapter 1 - Getting started - 11

Notice: if accidentally droppings, exposure to heat source and

12 - SpirHOMEter User Manual

Medical Device Directive (CE mark)

Chapter 1 - Getting started - 13

shows the button to click in the software to

14 - SpirHOMEter User Manual

Checking the packing contents

SpirHOMEter standard packaging

Code Qty Description

C00486-01-05 1 SpirHOMEter unit

Kit software SpirHOMEter standard packaging

Code Qty Description

Chapter 1 - Getting started - 15

Register the product via software

How to contact COSMED

Complain, feedback and suggestions

16 - SpirHOMEter User Manual

Chapter 1 - Getting started - 17

18 - SpirHOMEter User Manual

20 - SpirHOMEter User Manual

Install the turbine

22 - SpirHOMEter User Manual

Note: If the switch is already set to I, but the display doesn't

Access to Control Menu

24 - SpirHOMEter User Manual

Transmit data to the PC

Calibrate the flowmeter

Set-up date and time

Set-up patient data

26 - SpirHOMEter User Manual

Installing the software

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

Run the software

28 - SpirHOMEter User Manual

Show/hide the toolbar

Use of the keyboard

Use of the mouse

30 - SpirHOMEter User Manual

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

32 - SpirHOMEter User Manual

34 - SpirHOMEter User Manual

Using extra fields

Customise the fields

Chapter 5 - Database Management - 35

36 - SpirHOMEter User Manual

Import/export a Tests card