Pony FX User manual II Edition March 2004

Page 1

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 .

Pony FX User manual, II Edition

March 2004

Copyright © 2003 COSMED

Copyright © 2004 COSMED

COSMED Srl - Italy

http://www.cosmed.it

Part N. C02361-02-91

Page 3

FVC - Forced Vital Capacity ................................................................ 24

VC/IVC - Slow Vital Capacity and Ventilatory pattern........................ 25

MVV - Maximum Voluntary Ventilation ............................................. 25

Bronchoprovocation Response ............................................................. 25

Installation

27

Preparing Pony FX.................................................................28

Pony FX unit......................................................................................... 28

The display ..................................................................................... 28

The keyboard .................................................................................. 28

The printer ...................................................................................... 29

The connectors................................................................................ 29

Battery charger...................................................................................... 30

Connect the flowmeter to the Pony FX................................................. 31

The turbine flowmeter .................................................................... 31

The pneumotachograph .................................................................. 32

Connect the Pony FX to the PC ............................................................ 32

Connect the Pony FX to an external printer.......................................... 32

Software installation .............................................................33

Installing the software........................................................................... 33

Run the software ................................................................................... 33

PC port configuration............................................................................ 33

Software main features .........................................................34

Display.................................................................................................. 34

Tool bar................................................................................................. 34

Show/hide the toolbar..................................................................... 34

Dialog windows .................................................................................... 34

Use of the keyboard ........................................................................ 34

Use of the mouse ............................................................................ 34

Scroll bars ............................................................................................. 35

On-line help .......................................................................................... 35

Software version ................................................................................... 35

Calibration

37

The calibration program .......................................................38

Running the Calibration program ......................................................... 38

Log file ................................................................................................. 38

Index - 3

Page 4

Turbine calibration ................................................................39

Calibrating the turbine without a PC .....................................................39

Calibrating the turbine by means of a PC..............................................39

Checking the system signals .................................................41

The control panel...................................................................................41

Using the control panel ...................................................................41

Using Pony FX

43

Main functions of the Pony FX ...............................................44

Turning on/off the Pony FX ..................................................................44

Using the menu .....................................................................................44

Accessing the menu ........................................................................44

Using the keyboard................................................................................45

Logic of the keyboard .....................................................................46

Patient database management ............................................47

Create a new patient ..............................................................................47

Search a patient in archive.....................................................................48

Performing the spirometric tests ...........................................49

Recommendations for spirometry tests .................................................49

Forced Vital Capacity (pre) ...................................................................49

Test encouragement ........................................................................50

Slow Vital Capacity ..............................................................................50

Maximum Voluntary Ventilation ..........................................................51

Bronchial Provocation Test ...................................................................51

Bronchodilators test ........................................................................51

Bronchoconstrictor test ...................................................................52

Performing the oximetry test (option)...................................54

Recommendations for oximetry tests ....................................................54

Performing the test ................................................................................54

Viewing results.......................................................................56

View a test in archive ............................................................................56

Printing results.......................................................................57

Replace the printer paper.......................................................................57

Printing tests by means of the internal printer .......................................57

Printing tests by means of an external printer........................................57

Options...................................................................................58

General settings .....................................................................................58

4 - Pony FX User Manual

Page 5

Spirometry options................................................................................ 58

FVC Post options.................................................................................. 59

Printout options..................................................................................... 60

Advanced options ................................................................................. 60

Environmental data ............................................................................... 61

Restore of initial settings ...................................................................... 61

Other functions of Pony FX....................................................62

Calibration ............................................................................................ 62

Control panel ........................................................................................ 62

LCD contrast......................................................................................... 62

Paper feed ............................................................................................. 63

Memory deletion................................................................................... 63

Firmware version information .............................................................. 63

Reset.......................................................................................64

Reset of the unit .................................................................................... 64

Formatting the unit................................................................................ 64

Database Management

65

Settings ..................................................................................66

Graphs ............................................................................................ 66

Interface.......................................................................................... 66

Units of measurements ................................................................... 67

Using extra fields............................................................................ 67

Customise the fields........................................................................ 67

Patient's database .................................................................68

Patient Card .................................................................................... 68

Visit Card ....................................................................................... 69

Test Card ........................................................................................ 69

Import/export a Tests card .................................................................... 69

Diagnosis Database............................................................................... 69

Receiving data from the unit.................................................71

Archive maintenance.............................................................72

Reorganise the archive.......................................................................... 72

Delete the archive ................................................................................. 72

Backup and restore................................................................................ 72

Backup............................................................................................ 72

Restore............................................................................................ 73

Index - 5

Page 6

Spirometry

75

Setting spirometry options ....................................................76

Spirometry.............................................................................................76

Automatic Interpretation .................................................................76

Quality control ................................................................................77

Parameters manager ..............................................................................77

Predicted values manager ......................................................................78

Predicteds set ..................................................................................78

Set the current predicted..................................................................79

Formula definition...........................................................................79

Page set-up ............................................................................................80

Spirometry tests .....................................................................82

Recommendations for spirometry tests .................................................82

Forced Vital Capacity (pre) ....................................................83

Perform a FVC (pre) test .......................................................................83

Test encouragement...............................................................................84

Perform the FVC test with the encouragement ...............................84

Slow Vital Capacity ................................................................85

Perform a SVC test................................................................................85

Maximum Voluntary Ventilation ...........................................87

Perform a MVV test ..............................................................................87

Bronchial Provocation Test ....................................................88

Bronchodilator test ................................................................................88

Methacholine and Histamine Bronchial provocation Tests ...................88

Perform the test .....................................................................................89

Bronchial Provocation protocols Database............................................90

Enter a new Bronchial provocation protocol in the

archive.............................................................................................91

Viewing results.......................................................................92

Tests of the current patient..............................................................92

Delete a test.....................................................................................92

Printing results.......................................................................93

Printing Reports ....................................................................................93

Printing the active window....................................................................94

Printing a series of reports.....................................................................94

Electronic reports (*.pdf) ......................................................................94

Export data ............................................................................................95

Export a test ....................................................................................95

6 - Pony FX User Manual

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System maintenance

97

System maintenance .............................................................98

Cleaning and disinfection ..................................................................... 98

Cleaning the turbine flowmeter ...................................................... 99

Precautions during the cleaning of the turbine................................ 99

Suggested disinfection solutions................................................... 100

Inspections .......................................................................................... 100

Appendix

101

Service - Warranty...............................................................102

Warranty and limitation of liability..................................................... 102

Return goods policy for warranty or non warranty repair ................... 103

Repair Service Policy.......................................................................... 103

Privacy Information .............................................................105

Personal data treatment and purposes ................................................. 105

How your personal data are treated..................................................... 105

The consent is optional, but… ............................................................ 105

Holder of the treatment ....................................................................... 105

Customer rights................................................................................... 106

Converting factors configuration ........................................107

ATS 94 recommendations....................................................108

ATS recommendations ....................................................................... 108

Predicted values ..................................................................109

ERS93................................................................................................. 109

Reference Adult:........................................................................... 109

Reference Paediatric:.................................................................... 109

KNUDSON 83.................................................................................... 109

Reference Adult/ Paediatric:......................................................... 109

ITS (White race) ................................................................................. 109

Reference Adult/ Paediatric:......................................................... 109

ITS (Black race).................................................................................. 109

Reference Adult/ Paediatric:......................................................... 109

LAM ................................................................................................... 110

Reference Adult/ Paediatric:......................................................... 110

Multicéntrico de Barcelona................................................................. 110

Reference Adult/ Paediatric:......................................................... 110

NHANES III ....................................................................................... 110

Index - 7

Page 8

Reference Adult/ Paediatric: .........................................................110

Automatic diagnosis (algorithm) .........................................................110

Quality Control Messages ...................................................................111

References........................................................................... 112

8 - Pony FX User Manual

Page 9

Getting started

Page 10

Important notices

Intended use

Pony FX 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

Pony FX 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:

10 - Pony FX User Manual

Page 11

• 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;

3.

4.

5.

6.

7.

• 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.

Before powering the system, check the power cables and the

plugs. Damaged electrical parts must be replaced

immediately by authorised personnel.

The battery charger sold with Pony FX must be used only to

re-charge the battery. If you would like to perform test with

Pony FX connected to the mains, use the medical version

battery charger (see Installation chapter).

Cleaning residue, particulates, and other contaminates

(including pieces of torn or broken components) in the

breathing circuit pose a safety risk to the patient during

testing procedures. Aspiration of contaminates can

potentially be life-threatening. You must follow all the

cleaning procedures in System Maintenance, and you must

thoroughly inspect the components after cleaning and before

each patient test.

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).

Keep the device away from heat and flame source,

flammable or inflammable liquids or gases and explosive

atmospheres.

Chapter 1 - Getting started - 11

Page 12

8.

In accordance with their intended use Pony FX is not to be

handled together with other medical devices unless it is

clearly declared by the manufacturer itself.

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 Pony FX,

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

12 - Pony FX User Manual

Page 13

Contraindications

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.

Contraindications for the Spirometer tests

Absolute contraindications

For FVC, VC and MVV tests:

• Post-operating state from thoracic surgery

For FVC tests:

•

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

For FVC tests:

•

spontaneous post-pneumothorax state

•

arterial-venous aneurysm

•

strong arterial hypertension

• pregnancy with complications at the 3rd month.

For MVV test:

•

hyperventilation syndrome

Contraindications for Bronchial provocation tests

The bronchial provocation tests must be executed according to

the doctor’s discretion. There are not data that reveal specific

contraindication for the bronchial provocation test through

inhalation.

The modern standard processes have been revealing secure in

several clinical studies. However it is recommendable to respect

the following contraindications:

Chapter 1 - Getting started - 13

Page 14

Absolute contraindications

•

Serious bronchial obstruction (FEV1 in adults)

•

Recent myocardium infarct

•

Recent vascular-cerebral accident

•

Known arterial aneurysm

•

Incapacity for understanding the provocation test procedures

and its implications.

Relative contraindications

•

Bronchial obstruction caused by the respiratory manoeuvre.

•

Moderate or serious bronchial obstruction. For ex. Predicted

value FEV1 less than 1.51 in men and predicted value FEV1

in women less than 1.21.

•

Recent infection in the superior air tracts

•

During the asthmatic re-acuting

•

Hypertension

•

Pregnancy

•

A pharmacology treatment epilepsy

14 - Pony FX User Manual

Page 15

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

accessible.

•

Adequate floor space to assure access to the patient during

exercise testing.

•

Adequate ventilation in the room.

resuscitation

emergency

equipment

Chapter 1 - Getting started - 15

Page 16

Safety and conformity

Safety

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

Find reported below the complete classification of the device:

•

Internally powered equipment type BF device (used stand

alone), class II type BF device (used connected to mains)

•

Protection against water penetration: IP00,

equipment unprotected against water penetration

•

Non sterile device

•

Device not suitable in the presence of flammable

anaesthetics;

•

Continuous functioning equipment;

ordinary

EMC

The system 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

16 - Pony FX User Manual

Page 17

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

“Italic”

indicates a control or a key to be pressed.

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 - 17

Page 18

Systems Overview

Pony FX is a device designed for lung function screening; the

core of the system is the “intelligent” flowmeter, connected to the

main unit, with graphical colour display. It can be considered a

complete portable spirometric laboratory.

Pony FX can be connected to a PC in order to transfer and store

the performed tests, to view the tests and, if it is used the medical

grade battery charger, to perform the tests and display them on

the PC monitor.

The system is composed by the turbine flowmeter, the

measurement and data elaboration device, the communication

cable, the battery charger and by the Software pack.

18 - Pony FX User Manual

Page 19

Before starting

Before operating the Pony FX system we strongly recommend to

check the equipment and register you as a customer.

Checking the packing contents

Make sure that the package contains the items listed below. In

case of missing or damaged parts, please contact Cosmed

technical assistance.

Pony FX standard packaging

Code

Qty

Description

C00962-01-04

C02235-01-05

C02364-01-05

A 362 100 001

A 662 100 001

C01788-02-36

C00137-01-20

C00136-01-20

C00063-01-20

C00214-01-20

A 362 315 001

A 182 300 004

C02388-01-05

A 196 056 001

C00067-02-94

C01999-02-DC

C02361-04-91

1

1

1

1

2

1

20

20

1

1

1

5

1

2

1

1

1

Pony FX Unit

Turbine

Reader

Turbine cable

Nose clips

PC Software

Paediatric paper mouthpieces

Adult paper mouthpieces

Conic mouthpiece

Paediatric mouthpiece adapter

USB cable

Bacterial filter

Pony FX battery charger

Thermic paper

Registration card

Conformity declaration

User Manual

Chapter 1 - Getting started - 19

Page 20

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.

20 - Pony FX User Manual

Page 21

PC configuration required

•

Pentium II 350 MHz.

•

Windows 98, XP.

•

64 Mb RAM .

•

CD drive.

•

VGA, SVGA monitor.

•

USB or RS232 port.

•

Any Mouse and Printer compatible with the MS Windows™

operative system.

• PC conform to European Directive 89/336 EMC

If you use an external printer, it must support the PCL language

and have an USB port for data transmission.

The USB connection works properly only with Windows XP.

Otherwise, use the serial RS232 connection.

Chapter 1 - Getting started - 21

Page 22

Technical features

Flowmeter

Bidirectional digital turbine

(standard), disposable

pneumotachograph (option)

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

Mouthpieces:

Ø 31 and Ø22 mm

Internal temperature sensor:

0-50°C (32-122°F)

Dimensions:

198 x 238 x 76 mm

Weight:

1.2 kg

Supply:

4 Ni-Mh rechargeable batteries

1.3V, 2300 mAh, no memory

effect

Power supply AC/DC

220/110 VAC in, 12 VDC 1A out

(class II according to EN 60 601-1 standard)

Interface

RS232, USB-A, USB-B (for the

external printer)

LCD

320x240 STN colour backlighted

In-built printer

Thermo sensitive, 832 pixel per

line

Printer paper

112 cm, standard sensibility,

good stability , image duration 15

years

22 - Pony FX User Manual

Page 23

Measurements

Page 24

Measured parameters

FVC - Forced Vital Capacity

Symbol

Note: Some

parameters are

computed only by

the PC software.

UM

FVC

l

FEV1

l

FEV1/FVC% %

PEF

l/sec

FEV0.5

l

FEV6

l

FEV1/FEV6 %

FEV6/FVC% %

Best FVC

l

Best FEV1 l

Best PEF

l/sec

Vmax25% l/sec

Vmax50% l/sec

Vmax75% l/sec

FEF25-75% l/sec

FET100%

sec

FEV2

l

FEV3

l

FEV2/FVC% %

FEV3/FVC% %

FEV1/VC% %

FEF50-75% l/sec

FEF75-85% l/sec

FEF0.2-1.2% l/sec

FiVC

L

FiF25-75% l/sec

FiV1

l/sec

PIF

l/sec

VEXT

ml

PEFT

msec

24 - Pony FX User Manual

Parameter

Forced Expiratory Vital Capacity

Forced Expiratory Volume in 1 sec

FEV1 as a percentage of FVC

Peak Expiratory Flow

Forced Expiratory Volume in 0.5 sec

Forced Expiratory Volume in 6 sec

FEV1 as a percentage of FEV6

FEV6 as a percentage of FVC

Best Forced Expiratory Vital Capacity

Best Forced Expiratory Volume in 1 sec

Best Peak Expiratory Flow

Expiratory Flow @25% of the FVC

Expiratory Flow @50% of the FVC

Expiratory Flow @75% of the FVC

Mid-exp flow between 25-75%FVC

Forced expiratory time

Forced Expiratory Volume in 2 sec

Forced Expiratory Volume in 3 sec

FEV2 as a percentage of FVC

FEV3 as a percentage of FVC

Tiffenau index

Mid-exp flow between 50-75%FVC

Mid-exp flow between 75-85%FVC

Mid-exp flow between 0.2 l - 1.2 l

Inspiratory Forced Vital Capacity

Forced mid-inspiratory flow

Forced Inspiratory Volume in 1 sec

Peak Inspiratory Flow

Extrapolated Volume (back extrapolation)

Time to PEF (10% - 90%)

Page 25

VC/IVC - Slow Vital Capacity and Ventilatory pattern

Symbol

UM

Parameter

EVC

IVC

ERV

IRV

IC

VE

Vt

Rf

Ti

Te

Ttot

Ti/Ttot

Vt/ti

l

l

l

l

l

l/min

l

1/min

sec

sec

sec

—l/sec

Expiratory Vital Capacity

Inspiratory Vital Capacity

Expiratory Reserve Volume

Inspiratory Reserve Volume

Inspiratory Capacity

Expiratory Minute Ventilation

Tidal Volume

Respiratory Frequency

Duration of Inspiration

Duration of Expiration

Duration of Total breathing cycle

Ti/Ttot ratio

Vt/ti ratio

MVV - Maximum Voluntary Ventilation

Symbol

UM

Parameter

MVV

MVt

MRf

MVVt

l/min

l

1/min

sec

Maximum Voluntary Ventilation

Tidal Volume (during MVV)

Maximum Respiratory frequency

MVV duration time

Bronchoprovocation Response

Symbol

UM Parameter

FallFEV1

FallVmax50%

P10

P15

P20

%

%

———-

Fall in FEV1 from baseline or post diluent

Fall in Vmax50% from ref.

Provocative dose causing FEV1 to fall 10%

Provocative dose causing FEV1 to fall 15%

Provocative dose causing FEV1 to fall 20%

Chapter 2 - Measurements - 25