microQuark User manual V Edition Sept 2003

Table of contents Getting started

7

Important notices... 8 Intended use... 8 Warnings... 8 Contraindication ... 11 Contraindications for the Spirometer tests ... 11 Absolute contraindications ... 11 Relative contraindications ... 11 Contraindications for Bronchial provocation tests ... 11 Absolute contraindications ... 12 Relative contraindications ... 12 Environmental condition of use... 13 Safety and conformity ... 14 Safety... 14 EMC ... 14 Quality Assurance... 14 Medical Device Directive (CE mark) ... 14 Keynotes... 15 Typographic keynotes... 15 Graphic keynotes ... 15 Systems Overview ... 16 Before starting ... 17 Checking the packing contents ... 17 microQuark standard packaging ... 17 Warranty registration ... 18 Register the product via software ... 18 How to contact COSMED ... 18 Complain, feedback and suggestions... 18 PC configuration required ... 19 Technical features ... 20

Measurements

21

Measured parameters ... 22 2 - microQuark User Manual

FVC - Forced Vital Capacity... 22 VC/IVC - Slow Vital Capacity and Ventilatory pattern ... 23 MVV - Maximum Voluntary Ventilation... 23 Bronchoprovocation Response... 23

Installation

25

Prepare the microQuark ...26 Software installation ...27 Installing the software ... 27 Run the software... 27 PC port configuration ... 27 Software main features ...28 Display ... 28 Tool bar ... 28 Show/hide the toolbar... 28 Dialog windows... 28 Use of the keyboard ... 28 Use of the mouse... 28 Scroll bars... 29 On-line help... 29 Software version... 29

Calibration

31

The calibration program ...32 Running the Calibration program ... 32 Log file ... 32 Turbine calibration ...33 Checking the system signals ...35 The control panel... 35 Using the control panel ... 35

Database Management

37

Settings ...38 Graphs ... 38 Serial port... 38 Units of measurements ... 39 Using extra fields ... 39 Index - 3

Customise the fields... 39 Patient's database ... 40 Patient Card ... 40 Visit Card ... 41 Test Card ... 41 Import/export a Tests card ... 41 Diagnosis Database... 41 Archive maintenance ... 43 Reorganise the archive... 43 Delete the archive ... 43 Backup and restore... 43 Backup... 43 Restore... 44

Spirometry

45

Setting spirometry options ... 46 Spirometry ... 46 Automatic Interpretation... 46 Quality control... 47 Parameters manager ... 47 Predicted values manager ... 48 Predicteds set ... 48 Set the current predicted ... 49 Formula definition ... 49 Page set-up... 50 Spirometry tests ... 52 Recommendations for spirometry tests ... 52 Forced Vital Capacity (pre) ... 53 Perform a FVC (pre) test... 53 Test encouragement ... 54 Perform the FVC test with the encouragement ... 54 Slow Vital Capacity... 55 Perform a SVC test ... 55 Maximum Voluntary Ventilation ... 57 Perform a MVV test... 57 Bronchial Provocation Test ... 58 Bronchodilator test... 58

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Methacholine and Histamine Bronchial provocation Tests ... 58 Perform the test ... 59 Bronchial Provocation protocols Database... 60 Enter a new Bronchial provocation protocol in the archive... 61 Viewing results ...62 Tests of the current patient ... 62 Delete a test... 62 Printing results...63 Printing Reports... 63 Printing the active window... 64 Printing a series of reports... 64 Electronic reports (*.pdf)... 64 Export data ... 65 Export a test ... 65

System maintenance

67

System maintenance...68 Cleaning and disinfection ... 68 Cleaning the turbine flowmeter ... 69 Precautions during the cleaning of the turbine ... 69 Suggested disinfection solutions ... 70 Inspections... 70

Appendix

71 Service - Warranty...72 Warranty and limitation of liability ... 72 Return goods policy for warranty or non warranty repair... 73 Repair Service Policy ... 73 Privacy Information ...75 Personal data treatment and purposes... 75 How your personal data are treated ... 75 The consent is optional, but…... 75 Holder of the treatment... 75 Customer rights ... 76 Converting factors configuration ...77 ATS 94 recommendations...78

Index - 5

ATS recommendations ... 78 Predicted values... 79 ERS93... 79 Reference Adult:... 79 Reference Paediatric:... 79 KNUDSON 83... 79 Reference Adult/ Paediatric:... 79 ITS (White race) ... 79 Reference Adult/ Paediatric:... 79 ITS (Black race)... 79 Reference Adult/ Paediatric:... 79 LAM ... 80 Reference Adult/ Paediatric:... 80 Multicéntrico de Barcelona... 80 Reference Adult/ Paediatric:... 80 NHANES III ... 80 Reference Adult/ Paediatric:... 80 Automatic diagnosis (algorithm) ... 80 Quality Control Messages... 81 References... 82

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Important notices Intended use microQuark 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 microQuark 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: 8 - microQuark 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. 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. In accordance with their intended use microQuark is not to be handled together with other medical devices unless it is clearly declared by the manufacturer itself.

Chapter 1 - Getting started - 9

8.

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

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 - 11

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 - 13

Safety and conformity Safety

IEC 601-1 (1988) /EN 60 601-1 (1990); Find reported below the complete classification of the device: •

Class I type B device

•

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 ISO 9001 (Registration n° 387 Cermet) Medical Device Directive (CE mark)

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

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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 - 15

Systems Overview microQuark is an instrument designed for lung function screening; the core of the system is the “intelligent” flowmeter that, connected through the serial port (RS232), turns any Personal Computer (laptop or desktop) in a complete spirometric lab. The system is composed by the turbine flowmeter, the measurement and data elaboration device (lightweight and ergonomic), the communication cable and by the Software pack.

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Before starting Before operating the microQuark 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. microQuark standard packaging Code

Qty

Description

C00960-01-04 C02235-01-05 A 662 100 001 C01739-02-35 C00137-01-20 C00136-01-20 C00063-01-20 C00214-01-20 A 362 300 004 C00067-02-94 C02268-02-91 C01999-02-DC

1 1 2 1 20 20 1 1 1 1 1 1

microQuark unit Turbine Nose clips PC Software Paediatric paper mouthpieces Adult paper mouthpieces Conic mouthpiece Paediatric adapter Serial cable RS232 USB Power Registration card User manual Conformity declaration

Chapter 1 - Getting started - 17

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].

18 - microQuark User Manual

PC configuration required •

Pentium 133 MHz.

•

Windows 95, 98, XP.

•

16 Mb RAM .

•

3.5 drive.

•

VGA, SVGA monitor.

•

USB port.

•

Serial Port RS 232 available.

•

Any Mouse and Printer compatible with the MS Windows™ operative system.

•

PC conform to European Directive 89/336 EMC

Chapter 1 - Getting started - 19

Technical features Flowmeter Flow Range: Volume Range: Accuracy: Resistance @12 l/s: Mouthpieces: Serial port: Dimensions: Weight:

20 - microQuark User Manual

Bidirectional digital turbine 0.03 - 20 l/s 12 l ± 3% or 50 ml < 0.7 cmH2O/l/sec Ø 31 and Ø22 mm RS232C 150 x 45 x 53 mm 77g

Measurements