Pony FX User manual II Edition March 2004

Table of contents Getting started

9

Important notices...10 Intended use ...10 Warnings ...10 Contraindications...13 Contraindications for the Spirometer tests ...13 Absolute contraindications...13 Relative contraindications...13 Contraindications for Bronchial provocation tests ...13 Absolute contraindications...14 Relative contraindications...14 Environmental condition of use...15 Safety and conformity...16 Safety ...16 EMC...16 Quality Assurance ...16 Medical Device Directive (CE mark)...16 Keynotes...17 Typographic keynotes ...17 Graphic keynotes...17 Systems Overview ...18 Before starting ...19 Checking the packing contents...19 Pony FX standard packaging...19 Warranty registration ...20 Register the product via software...20 How to contact COSMED...20 Complain, feedback and suggestions ...20 PC configuration required ...21 Technical features...22

Measurements

23

Measured parameters ...24 2 - Pony FX User Manual

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

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

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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

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

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

Reference Adult/ Paediatric: ...110 Automatic diagnosis (algorithm) ...110 Quality Control Messages ...111 References... 112

8 - Pony FX User Manual

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

• 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

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

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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

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

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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

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

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

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

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

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: [email protected] Internet: http: //www.cosmed.it Complain, feedback and suggestions

If you have any complain, feedback information or suggestion, please inform us at [email protected].

20 - Pony FX User Manual

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