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.
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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

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