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, V Edition
10/2004
Copyright © 1999 COSMED
Copyright © 2003 COSMED
COSMED Srl - Italy
http://www.cosmed.it
Part N. C02046-02-91

2 - SpirHOMEter User Manual
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

Index - 3
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

4 - SpirHOMEter User Manual
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

Index - 5
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

6 - SpirHOMEter User Manual

Getting started

8 - SpirHOMEter User Manual
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:

Chapter 1 - Getting started - 9
•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.

10 - SpirHOMEter User Manual
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

Chapter 1 - Getting started - 11
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.

12 - SpirHOMEter User Manual
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.

Chapter 1 - Getting started - 13
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

14 - SpirHOMEter User Manual
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.

Chapter 1 - Getting started - 15
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

16 - SpirHOMEter 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: [phone]
email: [email protected]
Internet: http: //www.cosmed.it
Complain, feedback and suggestions
If you have any complain, feedback information or suggestion,
please inform us at co[email protected].

Chapter 1 - Getting started - 17
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

18 - SpirHOMEter User Manual
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

20 - SpirHOMEter User Manual
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%)