Cosmed Quark PFT 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 .

Quark PFT User manual, VII Edition September 2003

COSMED Srl - Italy

http://www.cosmed.it

Part N. C01340-02-91

Table of contents

Getting started 11

Important notices............................................................................ 12

Intended use .............................................................................12

Warnings .................................................................................. 12

Contraindication .............................................................................14

Contraindications for the Spirometer tests............................... 14

Absolute contraindications............................................. 14

Relative contraindications..............................................14

Contraindications for Bronchial provocation tests................... 14

Absolute contraindications............................................. 14

Relative contraindications..............................................14

Contraindications for Exercise testing ..................................... 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

Tests/Products table .................................................................18

Before starting ................................................................................ 19

Checking the packing contents................................................. 19

Quark PFT1 standard packaging.................................... 19

Quark PFT2 standard packaging.................................... 19

Quark PFT3 standard packaging.................................... 20

Quark PFT4 standard packaging.................................... 20

Quark PFT Ergo standard packaging............................. 21

Quark PFT2 ergo Standard packaging........................... 21

Quark PFT4 ergo Standard packaging........................... 22

Warranty registration ..................................................................... 23

How to contact COSMED ............................................. 23

Complain, feedback and suggestions............................. 23

Options/Accessories........................................................................ 24

PC configuration required .............................................................. 25

Technical features........................................................................... 26

Flowmeter ...................................................................... 26

Oxygen Sensor (O2) ....................................................... 26

Carbon Dioxide Sensor (CO2)........................................ 26

2 - Quark PFT User Manual

Carbon Monoxide sensor (CO)...................................... 26

Methane sensor (CH4).................................................... 26

Humidity absorber ......................................................... 26

Power Supply................................................................. 26

Environmental Sensors.................................................. 26

Dimension and Weight .................................................. 26

Aux inputs...................................................................... 26

Measurements 27

Pulmonary function tests and measured parameters ....................28

Spirometry Tests ...................................................................... 28

FVC - Forced Vital Capacity......................................... 28

VC/IVC - Slow Vital Capacity and Ventilatory pattern 28

MVV - Maximum Voluntary Ventilation...................... 29

Bronchoprovocation Response...................................... 29

Multi-breath Nitrogen wash-out .................................... 29

Closing Volume test ...................................................... 29

CO diffusion Test .......................................................... 29

Respiratory Drive - P0.1 Test........................................ 30

MIP/MEP....................................................................... 30

Cardio pulmonary Exercise Testing (CPET) ........................... 30

Breath by Breath exercise testing .................................. 30

Indirect Calorimetry....................................................... 31

Lactate Threshold (V-Slope) ......................................... 31

O2 Kinetics.................................................................... 31

Installation 33

Unpacking the system .....................................................................34

Setting up the system ......................................................................35

Installing the Calibration Gas Cylinders.................................. 35

Gas pressure adjustment procedure.......................................... 35

Connecting cables and tubing.........................................................36

Cables and Tubing’s installation sequence.............................. 37

Assemble the breathing valve .................................................. 37

Assemble the turbine ......................................................................38

Assemble the mask and the flowmeter .......................... 38

Using the "Ultimate Seal" ........................................................ 38

Apply the seal to the mask............................................. 39

To remove seal on mask ................................................ 39

Connecting PC ......................................................................... 39

Software installation .......................................................................40

Installing the software.............................................................. 40

Run the software ...................................................................... 40

PC port configuration............................................................... 40

Software main features...................................................................41

Display ..................................................................................... 41

Index - 3

Tool bar .................................................................................... 41

Show/hide the toolbar .................................................... 41

Dialog windows .......................................................................41

Use of the keyboard....................................................... 41

Use of the mouse............................................................ 41

Scroll bars ................................................................................ 41

On-line help.............................................................................. 41

Software version.......................................................................41

Calibration 43

Calibrating Sensors......................................................................... 44

Running the Calibration program............................................. 44

Log file..................................................................................... 44

Setting reference values ........................................................... 44

To set the reference values............................................. 44

Calibrating analysers................................................................ 45

ERGO Calibration.......................................................... 45

FRC Calibration............................................................. 45

DLCO Calibration.......................................................... 45

Print the calibration report ....................................................... 46

Edit the calibration factors ....................................................... 46

O2 delay check.......................................................................... 46

Turbine calibration ......................................................................... 47

The calibration syringe ..................................................47

Assembling the flowmeter for calibration .................... 47

Calibrating the turbine.............................................................. 48

Checking the system signals........................................................... 49

The control panel...................................................................... 49

Using the control panel.................................................. 49

Database Management 51

Spirometry patient's database........................................................ 52

Patient Card.................................................................... 52

Visit Card....................................................................... 52

Test Card........................................................................ 53

Import/export a Tests card ....................................................... 53

Diagnosis Database.................................................................. 53

Exercise testing patient's database ................................................54

Enter a new patient................................................................... 54

Find a patient............................................................................ 54

Edit patient data........................................................................54

Delete a patient......................................................................... 54

Archive maintenance ...................................................................... 55

Reorganise the archive............................................................. 55

Delete the archive..................................................................... 55

Delete a test.............................................................................. 55

4 - Quark PFT User Manual

Backup and restore................................................................... 55

Backup........................................................................... 55

Restore........................................................................... 55

Spirometry Settings .........................................................................56

Graphs............................................................................ 56

Serial port ...................................................................... 56

Units of measurements .................................................. 56

Using extra fields........................................................... 56

Customise the fields....................................................... 56

Spirometry 57

Setting spirometry options ..............................................................58

Spirometry................................................................................ 58

Automatic Interpretation................................................ 58

Quality control............................................................... 58

Parameters manager................................................................. 59

Predicted values manager......................................................... 59

Predicteds set ................................................................. 59

Set the current predicted................................................ 60

Formula definition ......................................................... 60

Page set-up............................................................................... 61

Spirometry tests...............................................................................62

Forced Vital Capacity (pre)..............................................................63

Recommendations.................................................................... 63

Perform a FVC (pre) test.......................................................... 63

Test encouragement ................................................................. 63

Perform the FVC test with the encouragement.............. 64

Slow Vital Capacity ..........................................................................65

Perform a SVC test .................................................................. 65

Maximum Voluntary Ventilation .....................................................66

Perform a MVV test................................................................. 66

Bronchial Provocation Test..............................................................67

Bronchodilator test................................................................... 67

Methacholine and Histamine Bronchial provocation Tests ..... 67

Perform the test........................................................................ 68

Bronchial Provocation protocols Database.............................. 68

Enter a new Bronchial provocation protocol in the

archive ........................................................................... 68

Viewing results................................................................................69

Tests of the current patient ............................................ 69

Delete a test ................................................................... 69

Printing results ................................................................................70

Printing Reports ....................................................................... 70

Printing the active window ...................................................... 71

To print the active window............................................ 71

Printing a series of reports ....................................................... 71

Electronic reports (*.pdf)......................................................... 71

Index - 5

Export data ............................................................................... 71

Export a test ................................................................... 71

Lung Volumes 73

Lung volumes tests (N2 washout) ................................................... 74

Recommendations.......................................................... 74

Setting N2 wash-out options.................................................... 74

Perform the test ........................................................................ 75

Closing Volume Test (CV) ................................................................ 76

Recommendations.......................................................... 76

Perform the test ........................................................................ 76

P0.1 Respiratory drive 79

P0,1 (Respiratory drive) .................................................................. 80

Aim of the test.......................................................................... 80

Setting respiratory drive options .............................................. 80

Recommendations.......................................................... 80

Perform the test ........................................................................ 80

Lung diffusing capacity 83

CO Diffusing Capacity (DLCO) Test.................................................. 84

Setting DLCO options.............................................................. 84

Recommendations.......................................................... 85

DLCO with breath-hold (standard technique).......................... 85

DLCO with apnoea (standard method) .................................... 85

DLCO without apnoea (“intrabreath” method)........................ 87

Multiple breath DLCO test (“Steady-State” method) .............. 87

MIP/MEP (option) 89

MIP/MEP test ................................................................................... 90

How to perform the test............................................................90

Pulse oximetry (option) 91

The oximetry test............................................................................. 92

How to perform the test............................................................92

Exercise testing 93

Recommendations for the exercise testing..................................... 94

The evaluation of the cardiorespiratory function ..................... 94

Precautions............................................................................... 94

Laboratory...................................................................... 94

Ending the test ...............................................................94

Preparing the patient ................................................................ 94

Before testing................................................................. 94

Patient assent.................................................................. 95

Ending the test ...............................................................95

6 - Quark PFT User Manual

Start Testing ....................................................................................96

Start a test ...................................................................... 96

Abort the test without saving data ................................. 96

End the test saving data ................................................. 96

View data in real-time.............................................................. 96

View graphs in real-time ............................................... 97

Parameters to view................................................................... 97

Manual protocol....................................................................... 97

Enter Load and Phase .................................................... 97

Set the markers .............................................................. 97

Automatic protocol .................................................................. 97

Modify the load during the test...................................... 97

Set the BPM alarm................................................................... 97

Enter the BPM ............................................................... 97

Data management ..........................................................................98

Viewing data ............................................................................ 98

View data in table form ................................................. 98

Creating graphs ........................................................................ 98

View data in graph form................................................ 98

Customise the graphs..................................................... 99

Switch from graph to data and vice versa...................... 99

Viewing predicted values....................................................... 100

View predicted values.................................................. 100

Anaerobic (Lactate) Threshold detection............................... 100

View the Lactate Threshold......................................... 100

Detect the Lactate Threshold....................................... 100

Customise graphs for the LT viewing.......................... 100

Fittings ................................................................................... 101

Fit a graph with a linear regression.............................. 101

Fit a graph with a Mono-exponential regression ......... 101

Calculate the "Mean Value" ........................................ 102

Oxygen Kinetic ...................................................................... 102

Run the O2 Kinetic function........................................ 102

Information about the Test..................................................... 103

View the Information................................................... 103

Modify the information................................................ 103

Summary................................................................................ 103

View the summary....................................................... 103

Print the data .......................................................................... 103

Print the current window ............................................. 104

Print the report............................................................. 104

View the report ...................................................................... 104

Data Editing ..................................................................................105

Editing values and input numerical values.................. 105

Data filtering................................................................ 105

Using the User fields ................................................... 106

Index - 7

Deleting steps............................................................... 106

Advanced Editing ........................................................106

Restore the original test ...............................................107

Overwrite the original test ........................................... 107

Customise the desktop............................................................ 107

Customise the display colours .....................................107

Smart edit ............................................................................... 107

Apply the graphical noise suppression ........................107

Apply the threshold noise suppression ........................107

Customise the parameters ......................................................108

Create a new parameter................................................ 108

a new predicted parameter................................. 108

Create

Exporting data ........................................................................ 109

Export a test ................................................................. 109

DDE with Excel........................................................... 109

Creating Test Protocols ................................................................. 110

Create a new protocol .................................................. 110

Software configuration .................................................................111

Data viewing .......................................................................... 111

Select the parameters to view ......................................111

Select the parameters to view during the test............... 111

Sort the parameters ...................................................... 111

Steady State............................................................................ 111

Customise the Steady State detection criteria.............. 111

Printout reports............................................................................. 112

Set up the printout........................................................ 112

Select parameters to be printed.................................... 112

Customise the printout header .....................................112

Electronic reports (*.pdf)............................................. 113

Print the current window........................................................ 113

Print the customised report..................................................... 113

Events management during exercise testing ...............................114

Flow Volume loops................................................................ 114

Flow Volume loop during the test ............................... 114

O2, CO2 vs Time ................................................................... 114

O2, CO2 vs Time during the test ................................. 114

O2 Saturation (optional)......................................................... 114

O2 Saturation during the test .......................................115

Spirogram............................................................................... 115

Spirogram during the test............................................. 115

View the events after the test ................................................. 115

Raw data................................................................................. 115

Save Raw data.............................................................. 115

Resting Metabolic Rate Test 117

Metabolism ................................................................................... 118

8 - Quark PFT User Manual

Total Metabolic Rate.............................................................. 118

Resting Metabolic Rate (RMR) ............................................. 118

Importance to measure RMR................................................. 118

Measurement of the rest metabolic rate with indirect

calorimetry............................................................................. 118

How to perform a RMR test................................................... 118

Recommendations .........................................................................119

Performing a test ..........................................................................120

Calibrations............................................................................ 120

How to prepare a patient........................................................ 120

Start the test............................................................................ 120

Viewing the test ..................................................................... 121

How to modify the average interval....................................... 122

Print........................................................................................ 122

Sub-maximal Exercise Testing 125

Introduction ...................................................................................126

Pre-test screening................................................................... 126

Sub-maximal exercise testing .......................................................127

Considerations with sub-maximal exercise testing................ 127

Staffing................................................................................... 128

Test termination ..................................................................... 128

Considerations for accuracy ..........................................................129

Performing the test .......................................................................130

An example of testing protocol.............................................. 130

System maintenance 131

System maintenance .....................................................................132

Cleaning and disinfection....................................................... 132

Cleaning the turbine flowmeter ................................... 133

Precautions during the cleaning of the turbine ............ 133

Suggested disinfection solutions.................................. 133

Cleaning the Breathing valve................................................. 133

Masks cleaning and disinfection............................................ 135

Disassembling the different parts of the mask............. 135

Cleaning the mask........................................................ 135

Disinfecting the mask.................................................. 135

Permapure maintenance......................................................... 135

Inspections ............................................................................. 135

Replace the fuses.................................................................... 135

Select the proper power supply voltage ................................. 136

Appendix 137

Service - Warranty ........................................................................138

Warranty and limitation of liability ....................................... 138

Return goods policy for warranty or non warranty repair...... 138

Repair Service Policy............................................................. 139

Index - 9

Privacy Information ......................................................................140

Personal data treatment and purposes .................................... 140

How your personal data are treated........................................ 140

The consent is optional, but… ............................................... 140

Holder of the treatment ..........................................................140

Customer rights...................................................................... 140

Heart Rate – TTL input .................................................................. 141

Converting factors configuration .................................................. 142

Calculations references................................................................. 143

VO2 and VCO2....................................................................... 143

Anaerobic threshold (modified V-Slope)............................... 143

References.................................................................... 143

O2 kinetics .............................................................................. 143

ATS 94 recommendations ............................................................. 144

ATS recommendations........................................................... 144

Predicted values ........................................................................... 145

ERS93 ....................................................................................145

Reference Adult:.......................................................... 145

Reference Paediatric:................................................... 145

KNUDSON 83 ....................................................................... 145

Reference Adult/ Paediatric:........................................ 145

ITS (White race)..................................................................... 145

Reference Adult/ Paediatric:........................................ 145

ITS (Black race)..................................................................... 145

Reference Adult/ Paediatric:........................................ 145

LAM....................................................................................... 145

Reference Adult/ Paediatric:........................................ 145

Multicéntrico de Barcelona.................................................... 145

Reference Adult/ Paediatric:........................................ 145

NHANES III........................................................................... 145

Reference Adult/ Paediatric:........................................ 145

Automatic diagnosis (algorithm)............................................ 146

Quality Control Messages...................................................... 146

References..................................................................................... 147

Spirometry ................................................................... 147

Lung Volumes.............................................................. 147

Single-Breath with Apnea............................................ 147

Single-Breath without Apnea....................................... 147

Gas Exchange References............................................ 147

Indirect calorimetry......................................................147

Sub-maximal testing .................................................... 147

10 - Quark PFT User Manual

Getting started

Important notices

Intended use

Quark PFT 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 Quark PFT 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

2. Safety, measure accuracy and precision can be assured only:

• using the accessories described in the manual or given with the device. Actually

• ordinary equipment maintenance, inspections, disinfection and cleaning are

• any modification or fixing is carried out by qualified personnel;

• the environmental conditions and the electrical plants where the device operates

3. Before powering the system, check the power cables and the plugs. Damaged

4. Large gas cylinders, which may be given by the manufacturer or purchased by the

5. When removing the protective cap, inspect the cylinder valve for damaged threads,

6. Be certain that the materials of the pressure regulators are chemically compatible

always be kept on hand.

non recommended accessories can affect safety unfavourable. Before using non recommended accessories it is necessary to get in touch with the manufacturer;

performed in the way and with the frequency described;

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.

electrical parts must be replaced immediately by authorised personnel.

customer, should be secured with cylinder safety chains or safety stands.

dirt, oil or grease. Remove any dust or dirt with a clean cloth. If oil or grease is present on the valve of a cylinder which contains oxygen, do not attempt to use. Such combustible substances in contact with oxygen are explosive.

with the intended gas service before installation. Inspect the regulator for the proper

12 - Quark PFT User Manual

connection and note the ranges of the pressure gauges. Also examine the physical condition of the regulator including threads and fittings. Remove any dust or dirt from the regulator or cylinder valve with a clean cloth. Do not install a regulator on a cylinder valve containing oxygen if grease or oil is present on either. Such substances in contact with oxygen are explosive.

7. 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.

8. 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).

9. Keep the device away from heat and flame source, flammable or inflammable liquids or gases and explosive atmospheres.

10. In accordance with their intended use Quark PFT is not to be handled together with other medical devices unless it is clearly declared by the manufacturer itself.

11. It is recommended to use a computer with electromagnetic compatibility CE marking and with low radiation emission displays.

12. It is necessary to make the PC, connected to the

Quark PFT, compliant with EN

60601-1 by means of an isolation transformer.

13. Graphical symbols used in accordance to present specifications are described here below:

Equipment type B (EN60601-1)

Danger: high temperature

OFF

Protective earth ground

Alternating current

Chapter 1 - Getting started - 13

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 3

For MVV test:

• hyperventilation syndrome

month.

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:

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

Contraindications for Exercise testing

Read carefully the exercise testing chapter.

14 - Quark PFT 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.

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:

• Class I type B device

• 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

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

16 - Quark PFT 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 - 17

Systems Overview

Quark PFT is a stationary and modular system designed for Pulmonary Function Testing. This system has been designed to meet the most accredited criteria and recommendations of the latest scientific publications.

The system incorporates “plug and play” circuitry, allowing the customisation of features and instant upgrades.

Quark PFT comes in the following configurations:

• PFT1; Spirometry, (FVC, SVC, MMV and bronchial-challenge tests).

• PFT2; adds Functional Residual Capacity testing via Nitrogen Washout and

Closing Volume techniques.

• PFT3; combines Spirometry plus Lung Diffusing Capacity testing by adding CO and CH

• PFT4; integrates PFT2 and PFT3 features to become the Complete Pulmonary Function Testing instrument.

• ERGO Option: The PFT 2 and PFT 4 can be enhanced with the Pulmonary Gas Exchange module, allowing “breath by breath” analysis, indirect calorimetry and RS232 ergometer control, PFT3 can be upgraded to PFT4 or PFT4 ERGO.

Tests/Products table

Test PFT 1 PFT 2 PFT 3 PFT 4 PFTErgoPFT2ergoPFT4ergo

Forced Vital Capacity • • • • option • •

Slow Vital Capacity • • • • option • •

Respiratory Pattern • • • • option • •

Maximum Voluntary Ventilation • • • • option • •

Bronchial Challenge Tests • • • • option • •

Nitrogen Wash-out • • • •

Closing Volume • • • •

Lung Diffusing Capacity • • •

P0.1 option option option option

Exercise Testing • • •

Indirect Calorimetry • • •

Oxymetry option option option option option option option

Ergometer Control • • •

Integration with Quark C12/T12 ECG option option option option option option

MIP-MEP option option option option option option

analysers.

18 - Quark PFT User Manual

Before starting

Before operating the Quark PFT 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.

Quark PFT1 standard packaging

Code Qty Description

C00931-01-04 1 Quark PFT 1 unit

C02120-01-05 1 Turbine Ø 28mm

C02171-01-11 1 Kit optoelectronic reader Quark PFT1

A 662 100 001 2 Nose clips

C01739-02-35 1 PC Software

C00137-01-20 50 Paediatric paper mouthpieces

C00136-01-20 50 Adult paper mouthpieces

A 362 060 001 1 Power cord Schuko L 2m

A 362 300 001 1 Serial cable RS 232 DB9 M/F

A 680 013 630 2 Time Lag Fuses 5x20 250V T630 mA

A 680 024 125 2 Time Lag Fuses 5x20 250V T 1,25A

C00067-02-94 1 Registration card

C01340-02-91 1 User manual Quark PFT

C01999-02-DC 1 Conformity declaration

Quark PFT2 standard packaging

Code Qty Description

C00932-01-04 1 Quark PFT 2 unit

C02120-01-05 1 Turbine Ø 28mm

C02171-02-11 1 Kit optoelectronic reader Quark PFT2/3/4

A 182 310 001 5 Antimoisture filter

C01590-01-05 1 Breathing valve PFT2 (1 way)

C00243-01-06 1 Calibration syringe 3 litres

C02210-02-08 1 Permapure L 2m

C00269-01-20 20 PTE soft mouthpieces

A 830 300 001 1 Air valve membrane

A 182 300 004 10 Antibacterial filter

A 108 106 002 2 Tank tubing 6x8 98 shore

A 662 100 001 2 Nose clips

C00137-01-20 50 Paediatric paper mouthpieces

C00136-01-20 50 Adult paper mouthpieces

C01739-02-35 1 PC software

A 362 060 001 1 Power cord Schuko L 2 mt

A 362 300 001 1 Serial cable RS 232 DB9 M/F

A 680 013 630 2 Time Lag Fuses 5x20 250V T630 mA

A 680 024 125 2 Time Lag Fuses 5x20 250V T1,25A

C00067-02-94 1 Registration card

C01340-02-91 1 User manual Quark PFT

C01999-02-DC 1 Conformity declaration

Chapter 1 - Getting started - 19

Quark PFT3 standard packaging

Code Qty Description

C00933-01-04 1 Quark PFT 3 unit

C02120-01-05 1 Turbine Ø 28mm

C02171-02-11 1 Kit optoelectronic reader Quark PFT2/3/4

C01730-01-05 1 Breathing valve PFT3/4 (3 ways)

C00243-01-06 1 Calibration syringe 3 litres

C02210-02-08 2 Permapure L 2 m

A 182 300 004 10 Antibacterial filter

A 830 300 001 1 Air valve membrane

A 662 100 001 2 Nose clips

C00137-01-20 50 Paediatric paper mouthpieces

C00136-01-20 50 Adult paper mouthpieces

A 182 310 001 5 Antimoisture filter

C00269-01-20 20 PTE soft mouthpieces

C01739-02-35 1 PC software

A 108 106 002 1 Tank tubing 6x8 98 shore

A 362 060 001 1 Power cord Schuko L 2 mt

A 362 300 001 1 Serial cable RS 232 DB9 M/F

A 680 013 630 2 Time Lag Fuses 5x20 250V T630 mA

A 680 024 125 2 Time Lag Fuses 5x20 250V T630 mA

C00067-01-94 1 Registration card

C01340-02-91 1 User manual Quark PFT

C01999-02-DC 1 Conformity declaration

Quark PFT4 standard packaging

Code Qty Description

C00934-01-04 1 Quark PFT4 unit

C02120-01-05 1 Turbine Ø 28mm

C02171-02-11 1 Kit optoelectronic reader Quark PFT 2/3/4

C01730-01-05 1 Breathing valve PFT3/4 (3 ways)

C00243-01-06 1 Calibration syringe 3 litres

C02210-02-08 2 Permapure L 2 m

A 182 300 004 10 Antibacterial filter

A 662 100 001 2 Nose clips

C00137-01-20 50 Paediatric paper mouthpieces

C00136-01-20 50 Adult paper mouthpieces

A 182 310 001 5 Antimoisture filter

C01739-02-35 1 PC software

A 362 060 001 1 Power cord Schuko 2 mt

A 362 300 001 1 Serial cable RS 232 DB9 M/F

A 108 106 002 3 Tank Tubing 6x8 shore

A 830 300 001 1 Air valve membrane

A 680 013 630 2 Time Lag Fuses 5x20 250V T630 mA

A 680 024 125 2 Time Lag Fuses 5x20 250V T1,25A

C00067-02-94 1 Registration card

C00269-01-20 20 PTE soft mouthpieces

C01340-02-91 1 User manual Quark PFT

C01999-02-DC 1 Conformity declaration

20 - Quark PFT User Manual

Quark PFT Ergo standard packaging

Code Qty Description

C00935-01-04 1 Quark PFT Ergo unit

C02120-01-05 1 Turbine Ø 28mm

C02170-01-11 1 Kit optoelectronic reader Ergo

C00243-01-06 1 Calibration syringe 3 litres

C02210-02-08 2 Permapure L 2 m

C01399-02-12 1 Cable in HR TTL

A 800 900 001 2 Head cap for the adult masks

C02125-01-10 1 Mask mouth/nose breath adult S

C02135-01-10 1 Mask mouth/nose breath adult M

C02145-01-10 1 Mask mouth/nose breath adult L

A 182 310 001 5 Anti moisture filter

C01739-02-35 1 PC software Spiro

C01740-02-35 1 PC software Ergo

A 362 060 001 1 Power cord Schuko L 2m

A 362 300 001 1 Serial cable RS 232 DB9 M/F

A 108 106 002 1 Tank tubing 6x8 98 Shore

C00861-01-06 1 HR probe

A 661 200 001 1 Polar belt

A 661 200 002 1 HR transmitter watertight

A 680 013 630 2 Time Lag Fuses 5x20 250V T630 mA

A 680 024 125 2 Time Lag Fuses 5x20 250V T1,25A

C00067-02-94 1 Registration card

C01340-02-91 1 User manual Quark PFT

C01999-02-DC 1 Conformity declaration

Quark PFT2 ergo Standard packaging

Code Qty Description

C00936-01-04 1 Quark PFT2 ergo unit

C02120-01-05 1 Turbine Ø 28mm

C02171-02-11 1 Kit optoelectronic reader Quark PFT 2/3/4

C01590-01-05 1 Breathing valve PFT2

A 800 900 001 2 Head cap for the adult masks

C00243-01-06 1 Calibration Syringe 3L

A 108 106 002 2 Tank tubing 6x8 98 shore

C02210-02-08 2 Permapure L2m

C01399-02-12 1 Cable in HR TTL

C02125-01-10 1 Mask mouth/nose breath adult S

C02135-01-10 1 Mask mouth/nose breath adult M

C02145-01-10 1 Mask mouth/nose breath adult L

C00861-01-06 1 HR probe

A 661 200 001 1 HR elastic belt

A 661 200 002 1 HR polar transmitter

C00269-01-20 20 PTE soft mouthpiece

C00137-01-20 50 Paediatric paper mouthpieces

C00136-01-20 50 Adult paper mouthpieces

A 182 300 005 10 Antibacterial filter

A 182 310 001 5 Anti moisture filter

A 362 060 001 1 Power cord Schuko 2m

Chapter 1 - Getting started - 21

A 362 300 001 1 RS232 cable DB9 M/F

A 662 100 001 2 Nose clips

A 680 013 630 2 Time lag fuses 5x20 250V T630mA

A 680 024 125 2 Time lag fuses 5x20 250V T1,25A

A 830 300 001 1 Air valve membrane

C01739-02-35 1 PC software Spiro

C01740-02-35 1 PC software Ergo

C01999-01-DC 1 Conformity declaration

C00067-02-94 1 Registration card

C01340-02-91 1 Quark PFT User Manual

Quark PFT4 ergo Standard packaging

Code Qty Description

C00937-01-04 1 Quark PFT4 ergo unit

C02120-01-05 1 Turbine Ø 28mm

C02171-02-11 1 Kit optoelectronic reader Quark PFT 2/3/4

A 800 900 001 2 Head cap for the adult masks

C00243-01-06 1 Calibration Syringe 3L

A 108 106 002 3 Tank tubing 6x8 98 shore

C02210-02-08 1 Permapure L2m

C01399-02-12 1 Cable in HR TTL

C02125-01-10 1 Mask mouth/nose breath adult S

C02135-01-10 1 Mask mouth/nose breath adult M

C02145-01-10 1 Mask mouth/nose breath adult L

C00861-01-06 1 HR probe

A 661 200 001 1 HR elastic belt

A 661 200 002 1 HR polar transmitter

C00269-01-20 20 PTE soft mouthpiece

C00137-01-20 50 Paediatric paper mouthpieces

C00136-01-20 50 Adult paper mouthpieces

A 182 300 005 10 Antibacterial filter

A 182 310 001 5 Anti moisture filter

A 362 060 001 1 Power cord Schuko 2m

A 362 300 001 1 RS232 cable DB9 M/F

A 662 100 001 2 Nose clips

A 680 013 630 2 Time lag fuses 5x20 250V T630mA

A 680 024 125 2 Time lag fuses 5x20 250V T1,25A

A 830 300 001 1 Air valve membrane

C01739-02-35 1 PC software Spiro

C01740-02-35 1 PC software Ergo

C01999-01-DC 1 Conformity declaration

C00067-02-94 1 Registration card

C01340-02-91 1 Quark PFT User Manual

22 - Quark PFT 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.

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.

Chapter 1 - Getting started - 23

Options/Accessories

The following options are available to enhance or to complete the Quark PFT system:

Code Quantity Description

A 860 000 004 1 Calibration cylinder (5% CO2, 16% O2, balance N2)

A 860 000 005 1 DLCO cylinder (0.3% CO, 0.3& CH4, 21% O2, balance N2)

A 860 000 006 1 DLCO st. state cylinder (0.3% CO, 0.3% CH4, 21% O2, balance N2)

A 860 000 007 1 O2 cylinder

C01500-01-04 1 Trolley for Quark PFT

C01700-01-04 1 Trolley with arm for Quark PFT

A 870 150 001 1 Pressure regulator for cal./DLCO cylinder

A 870 150 002 1 Pressure regulator for O2 cylinder

C09001-02-99 1 Spirovis system for MIP and MEP measurement

C00689-01-30 1 Mask mouth/nose breath ID28 adult XL

C01278-01-30 1 Mask mouth/nose breath ID28 paediatric L

C01277-01-30 1 Mask mouth/nose breath ID28 paediatric S

A 800 900 004 1 Paediatric Headcap

24 - Quark PFT User Manual

PC configuration required

• Pentium 133 MHz.

• Windows 95, 98, XP.

• 16 Mb RAM .

• 3.5 drive.

• VGA, SVGA monitor.

• Serial Port RS 232 available (2 serial ports in case of Ergometer control). An USB

port can replace one RS232 serial port, if using the USB-RS232 adaptor (Cosmed code A 388 410 001).

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

• PC conform to European Directive 89/336 EMC

Chapter 1 - Getting started - 25

Technical features

Flowmeter

Type: Bidirectional digital turbine Ø 28 mm Flow Range: 0,03-20 L/sec Accuracy: ± 2% Resistance: <0.7 cmH

Ventilation Range: 0-300 litres x min

Oxygen Sensor (O2)

Type Galvanic Fuel Cell Paramagnetic (option) Response time: <120 ms <120 ms Range: 0-100% O Accuracy: ±0.05% O

Carbon Dioxide Sensor (CO2)

Type: NDIR Response time: <120 ms Range: 0-15% Accuracy: ±0.03%

O s/L @ 12 L/s

0-100% O2

±0.03% O2

Carbon Monoxide sensor (CO)

Type: NDIR Response time: <200 ms Range: 0-0.3% Accuracy: ±0,003%

Methane sensor (CH4)

Type: NDIR Response time: <200 ms Range: 0-0.3% Accuracy: ±0,003%

Humidity absorber

Capillary of Nafion (Permapure ®)

Power Supply

Voltage: 100V-240V ±10%; 50/60Hz Power consumption 100W

Environmental Sensors

Temperature: 0-50°C Barometer: 400-800 mmHg Humidity: 0-100%

Dimension and Weight

Dimensions: 17x30x45 cm Weight: 8 Kg

Aux inputs

With the auxiliary RS 232 port and the digital (TTL) input for external ECG signal, Quark PFT offers the possibility to integrate data coming from many equipment such as ECGs and ergometers.

26 - Quark PFT User Manual

Measurements

Pulmonary function tests and measured parameters

Spirometry Tests

FVC - Forced Vital Capacity

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 when 75% of the FVC remains to be exhaled

Vmax50% l/sec Expiratory Flow when 50% of the FVC remains to be exhaled

Vmax75% l/sec Expiratory Flow when 25% of the FVC remains to be exhaled

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%)

VC/IVC - Slow Vital Capacity and Ventilatory pattern

Symbol UM Parameter

EVC l Expiratory Vital Capacity

IVC l Inspiratory Vital Capacity

ERV l Expiratory Reserve Volume

IRV l Inspiratory Reserve Volume

IC l Inspiratory Capacity

VE l/min Expiratory Minute Ventilation

Vt l Tidal Volume

Rf 1/min Respiratory Frequency

Ti sec Duration of Inspiration

Te sec Duration of Expiration

28 - Quark PFT User Manual

Ttot sec Duration of Total breathing cycle

Ti/Ttot —- Ti/Ttot ratio

Vt/ti l/sec Vt/ti ratio

MVV - Maximum Voluntary Ventilation

Symbol UM Parameter

MVV l/min Maximum Voluntary Ventilation

MVt l Tidal Volume (during MVV)

MRf 1/min Maximum Respiratory frequency

MVVt sec MVV duration time

Bronchoprovocation Response

Symbol UM Parameter

FallFEV1 % Fall in FEV1 from baseline or post diluent

FallVmax50% % Fall in Vmax50% from baseline or post diluent

P10 —- Provocative dose causing FEV1 to fall 10% from baseline

P15 —- Provocative dose causing FEV1 to fall 15% from baseline

P20 —- Provocative dose causing FEV1 to fall 20% from baseline

Multi-breath Nitrogen wash-out

Symbol UM Parameter

FRC l Functional Residual Capacity

RV l Residual Volume

TLC l Total Lung Capacity

Vtot l Total volume during the test

FetN2 % Final Nitrogen Concentration

Wash-out time m Duration of wash-out

VDA L Anatomic dead space

LCI mm:ss Lung Clearance Index

AMDN mm:ss Mean Dilution Number

FRC/TLC % FRC/TLC ratio

CEV l Cumulated Volume of inspired Oxygen

RV/TLC % RV/TLC ratio (Motley index)

Closing Volume test

Symbol UM Parameter

CV l Closing Volume

VC(c.v.) l Expired volume during wash-out

V_I l Related Volume at the end of phase I

V_II l Related Volume at the end of phase II

V_III l Related Volume at the end of phase III

m, q, R^2 l Parameters of the linear fitting on the alveolar plateau

CV/VC% % CV as a percentage of VC

VDf ml Dead volume (Fowler)

CO diffusion Test

Symbol UM Parameter

DLco ml/min/mmHg CO Diffusion Capacity

DLco 3eq ml/min/mmHg DLco computed with the Three Equations method.

Chapter 2 - Measurements - 29

DLco corr ml/min/mmHg CO Diffusion Capacity corrected for Hb, COHb, PB.

DLco/VA ml/min/mmHg Krogh factor

Dm ml/min/mmHg Membrane Diffusion capacity

Vc ml Capillary Volume

FaCO % Alveolar concentration of CO

FACH4 % Alveolar concentration of CH4

ta sec Apnoea time

FiCO % Inspiratory concentration of CO

FiCH4 % Expiratory concentration of CH4

wash-out vol. % Rejection Volume

Vsample vol. % Sampling volume

IVC (DLCO) l IVC calculated during test DLCO

TLC (DLCO) l Total Lung Capacity

Respiratory Drive - P0.1 Test

Symbol UM Parameter

P0.1 cmH2O Respiratory drive

FiCO2 % Inspiratory CO2 (PFT2 and PFT4 only)

RF 1/min Respiratory Frequency

Vt l Tidal Volume

MIP/MEP

Symbol UM Parameter

MIP cm H2O Maximum inspiratory pressure

MEP cm H2O Maximum expiratory pressure

Cardio pulmonary Exercise Testing (CPET)

The Ergo option makes the Quark PFT a complete Cardiopulmonary Exercise Testing system able to measure the following parameters:

Breath by Breath exercise testing

Symbol UM Parameter

VO2 ml/min Oxygen Uptake

VCO2

Vt l Tidal Volume

FetO2 % End Tidal O2

FetCO2 % End Tidal CO2

R --- Respiratory Quotient

VE l/min Ventilation

HR 1/min Heart Rate

Qt l Cardiac output

AT --- Anaerobic Threshold

VE l/min Ventilation

SV l/min Stroke volume

RF 1/min Respiratory Frequency

FeO2, FeCO2 % Averaged expiratory concentration of O2 e CO

VE/VO2 --- ventilatory equivalent for O2

VE/VCO2 --- ventilatory equivalent for CO2

VO2/HR ml/beat Oxygen pulse

VO2/Kg ml/min/Kg VO2 per Kg

ml/min

Carbon Dioxide production

30 - Quark PFT User Manual

Ti, Te, Ti/Ttot sec time breaths

Vd/Vt --- Vd/Vt ratio

PaCO2 mmHg arterial PCO2 (estimated)

P(a-et)CO2 mmHg Delta PaCO2 – PetCO2

Indirect Calorimetry

Symbol UM Parameter

EE Kcal/day Energy Expenditure

EE/BSA Kcal/day/m2 Energy Expenditure/Body surface area

EE/Kg Kcal/day/Kg Energy Expenditure pro Kg

FAT Kcal/day Fats

CHO Kcal/day Carbohydrate

PRO Kcal/day Protein

FAT% % % Fat

CHO% % % Carbohydrate

PRO% % % Protein

npRQ —- Respiratory quotient not protein

Lactate Threshold (V-Slope)

Symbol UM Description

VO2 @ LT l/m Lactate (Anaerobic) Threshold STPD

R @ LT -- Respiratory Quotient @ LT

Time @ LT hh:mm:ss Time @ LT

VCO2 ml/min CO2 output @ LT STPD

VE l/min Ventilation @ LT BTPS

HR bpm Heart Rate @ LT

O2 Kinetics

Parameter UM Calculation

O2 deficit l/m VO2@work*tau

O2 debt l/m VO2'@work*tau

Chapter 2 - Measurements - 31

32 - Quark PFT User Manual

Installation

Unpacking the system

On receipt of your system, you should immediately inspect your package for shipping damages, in case damage is suspected please contact the reseller immediately. Your system has to be installed by COSMED or by an authorised reseller.

Excessive amount of dust and miscellaneous clutter around the instrument can eventually cause malfunctions due to overheating of components, we strongly suggest to keep the unit in a clean environment and well ventilated as possible.

Quark PFT and accessories can have place on the trolley as shown in the following illustration.

34 - Quark PFT User Manual

Setting up the system

Before starting operating with the system make sure to meet the environmental and operational conditions reported in Chapter 1.

Installing the Calibration Gas Cylinders

In order to calibrate the sensors you need to have available calibration cylinders with the following gas concentrations:

Cylinder Recommended Gas mixture Test

Calibration O2 16%, CO2 5%, N2 Bal Washout, CV, P0.1, Ergo, MIP-MEP

DLCO CO 0.3%, CH4 0.3%, O2 21%, N2 Bal DLCO

Oxygen O2 100 % Washout, CV

Gas pressure adjustment procedure

The gas regulator has an adjustable second stage that must be adjusted only when used for the first time. This is necessary to protect the internal demand valve from the high pressure surge that can be generated when the cylinder is opened.

1. Make sure that the regulator is turned off before opening the cylinder valve.

2. Open the cylinder valve by turning the valve counter-clockwise.



Notice: The cylinders must be provided with a calibration certificate, indicating the gas composition.

3. Adjust the regulator pressure by turning the adjustment knob clockwise in order to reach a value between 5 and 6 atmospheres (bar).

Notice: The gas cylinder must be replaced when the primary pressure gauge falls below 10 bar.

Chapter 3 - Installation - 35

Connecting cables and tubing

The assembling procedure will be shown in the following illustrations.

A Heart Rate Probe connector

D Flowmeter connector

E Calibration plug

F Power switch

G Sampling tube connector

H Breathing valve connector

I DLCO mix gas connector

L Cal gas (16% O

M O

O RS232 Serial Port for PC connection

P Ground snap connector

Q Power cable connector

R Switch 110V / 220V

36 - Quark PFT User Manual

gas connector

, 5% CO2) connector

Cables and Tubing’s installation sequence

1. Connect the power cable of the Quark PFT to the trolley

2. Connect the power cable of the PC and the printer to the trolley

3. Connect the RS232 cable from the Quark PFT (PC RS232) to the PC (COM1 or COM2). If the PC does not have a RS232 port, please use the USB-RS232 adapter (A 388 410 001), available as an accessory.

4. Connect the DLCO cylinder to the Quark PFT (DLCO) and adjust its pressure between 5 and 6 bar.

5. Connect the O2 cylinder to the Quark PFT (O and 6 bar.

6. Connect the O

-CO2 calibration cylinder to the Quark PFT (CAL) and adjust its

pressure between 5 and 6 bar.

7. Connect the Flowmeter to the front panel of the Quark

Assemble the breathing valve

) and adjust its pressure between 5

Chapter 3 - Installation - 37

Assemble the turbine

Assemble the mask and the flowmeter

1. Insert the turbine in the optoelectronic reader, in the way indicated by the arrow in the turbine.

2. Insert the turbine plug on the front panel.



Notice: It is advisable to lubricate periodically the Orings inside the optoelectronic reader with sylicone grease for its good maintenance.

3. Connect the external anti moisture filter to the sampling plug and joint the

Using the "Ultimate Seal"

The "ultimate seal" is a moulded of Elasto-Gel, a glycerine based hydrogel. This product is a unique polymer gel that forms an intimate seal between the face and the mask. It has to be used for mask applications on hard to seal faces and where leaks are not tolerated.

• Will not irritate the skin

• Contains no adhesives.

• Has no odour

• Will not dry out

• Single patient use

Permapure sampling line to the filter. It's strongly suggest to use the filter always and we recommend to replace it every 3 months.

38 - Quark PFT User Manual



Notice: Avoid the exposure to the sun. Do not put the seal into the water.

Connecting PC

Apply the seal to the mask

Apply seal to clean, residue-free mask only and follow the instructions below:

1. Remove the plastic tray from the bag. Peel off clear film and retain for later use.

2. While holding tray align the nose area of mask to nose area of Ultimate Seal™ gel. Press together and roll mask down over the surface of the gel seal attaching it to the mask and releasing it from the tray.

3. If needed, adjust the position of the seal, aligning it with the outer perimeter of the mask sealing surface.

4. The mask is now ready to be placed on the subject's face.

To remove seal on mask

• The Ultimate Seal™ have been conceived for a single patient use only, it can not be cleaned or sterilised.

• If mask requires cleaning for a new patient application then pull off and dispose of the Ultimate Seal™.

• To keep the seal clean between use, keep it attached to the mask and place the clear film against the Ultimate Seal™ gel on the mask. When the seal becomes discoloured or opaque (approximately two weeks) dispose of the current seal and replace it with a new one.

Before operating the system make sure the unit is connected to the PC as described in the following illustration:

Chapter 3 - Installation - 39

Software installation

The software is made of two programs: one for the spirometry and the other one for the ergometry (only for PFTergo, PFT2ergo and PFT4 ergo). The two programs share the same archive and use the same program for the system calibration, even if they are used for performing completely different tests.

Installing the software

1. Select Run... from Windows Start menu.



Notice: The software is copy-protected. Install the software from the original disk.

Run the software

2. In the Command line box, type a:\install (assuming the disk is in drive A:).

3. Click on OK (or press ENTER key).

4. The program will load up a dialog box and ask for a directory where to be installed.

5. When the installation is over, the program will advise you with a message indicating that the installation has been successfully completed, click on End.

Note: the directory for the Ergo software must be the same of the Quark PFT (spiro).

1. In the Windows Program Manager, open the Program Group in which the software was installed.

2. Click the Quark PFT icon.

PC port configuration

The first time the software is used, it is necessary to configure the communication port with the PC (USB, COM1, COM2,…).

For further details, see the chapter Database management.

40 - Quark PFT User Manual

Software main features

Display

The program may contain several windows. The active window is highlighted with a different colour of the caption. Some functions of the program are "active window" sensitive (Print, right key of the mouse).

Tool bar

Many of the functions that may be selected from the menu can be activated more rapidly by clicking with the mouse on the corresponding icon in the tool bar.

Positioning the mouse cursor on one of the buttons of the toolbar (if the option Hints is enabled), the description of the corresponding function is shown in a label.

Show/hide the toolbar

Select Toolbar from Options menu in order to show or hide the toolbar.

Dialog windows

The typical operating environment of Microsoft Windows is the Dialog box. This window is provided with a series of fields in which input the information.

Scroll bars

On-line help

Use of the keyboard

• To move the cursor among fields, press the Tab key until you reach the desired field.

• Press the Enter key to confirm the information input on the dialog box or press the Esc key to cancel changes.

Use of the mouse

• To move the cursor among fields, move the mouse on the desired field and leftclick.

• Click on the OK button with the Left button of the mouse to confirm the information input on the dialog box or click on Cancel button to cancel changes.

Some windows are provided with scroll bars that help to see data exceeding the window space available.

• To move the scroll bar row by row click the scroll arrows at the end of the scroll bars

• To move the scroll bar page by page click on the grey area at both sides of the scroll fields

COSMED Quark Help is a complete on-line reference tool that you can use at any time. Help is especially useful when you need information quickly or when the Quark user manual is not available. Help contains a description of each command and dialog box, and explains many procedures for accomplishing common tasks.

To get the Help on line, press the F1 key.

Software version

To know the software version and the serial number of the software, select About Quark PFT… from Help menu.

Chapter 3 - Installation - 41

42 - Quark PFT User Manual

Calibration

Calibrating Sensors

The software allows to automatically calibrate zero, gain and delay of gas sensors. Even if the program doesn't force you to carry out the calibration we strongly recommend to execute it before each test.

Running the Calibration program

Start the program and choose Calibration from the Test Menu. The software runs the Calibration software and the main menu changes accordingly.

Log file

The program creates and updates as default the calibration log file, containing the conditions and the results of all the calibrations performed by the user.

To access the file select File/Report File... from the calibration program.

Setting reference values

Before starting calibrating make sure that the system has been configured correctly by setting the right values of gas concentration of: room air (i.e. 20.95% O CO

), of gas mixture contained in the cylinders and the volume of the calibration

syringe (i.e. 3 litres).

and 0.03%

To set the reference values

This operation must be performed only the first time. The next times, the system keeps stored the reference values entered in this step.

1. Select Reference Values from the Calibration menu.

2. Type the correct values for the O

and CO2 room air concentration (i.e. 2093 for

20.93%), and do the same for the gas concentration of the calibration cylinder.

3. Type the volume of the calibration syringe (i.e. 3000 for a 3 litres calibration syringe).

4. Press OK button to confirm changes.

44 - Quark PFT User Manual

Calibrating analysers



Note: After turning on the unit, wait 30 minutes warm up time before starting the calibration procedure.

ERGO Calibration

This calibration must be repeated at least daily. A new calibration before any ergospirometry, P0.1 or MIP-MEP test is strongly recommended.

1. Remove the sampling line from the flowmeter.

2. Ensure that the O

3. Check if the reference values for the calibration gas specified in File/Reference

4. Connect the sampling line to the CAL port placed on the front panel of the Quark

5. Select Calibration/Gas…/ERGO… and wait until the procedure is completed.

The software performs automatically the calibration procedure. After 90 seconds the graph will be displayed. In this way, the user can check the calibration procedure both graphically and numerically.

At the end of the procedure, the software displays the new calibration factors vs. the old ones.

-CO2 cylinder is properly connected to the rear panel of the

Quark PFT and check that the pressure of the gas is in the range 5-6 bar.

values… correspond to the certified composition of the mixture.

PFT.

FRC Calibration

This calibration must be repeated at least daily. A new calibration before any FRC or CV test is strongly recommended.

1. Remove the sampling line from the flowmeter.

2. Ensure that the O

cylinder is properly connected to the rear panel of the Quark PFT

and check that the pressure of the gas is in the range 5-6 bar.

3. Ensure that the O

-CO2 cylinder is properly connected to the rear panel of the

Quark PFT and check that the pressure of the gas is in the range 5-6 bar.

4. Check if the reference values for the calibration gas specified in File/Reference values… correspond to the certified composition of the mixture.

5. Connect the sampling line to the CAL port placed on the front panel of the Quark PFT.

6. Select Calibration/Gas…/FRC… and wait until the procedure is completed.

DLCO Calibration

This calibration must be repeated at least daily. A new calibration before any DLCO test is strongly recommended.

1. Remove the sampling line from the flowmeter.

Chapter 4 - Calibration - 45

2. Ensure that the DLCO cylinder is properly connected to the rear panel of the Quark PFT and check that the pressure of the gas is in the range 5-6 bar.

3. Check if the reference values for the calibration gas specified in File/Reference values… correspond to the certified composition of the mixture.

4. Connect the sampling line to the CAL port placed on the front panel of the Quark PFT.

5. Select Calibration/Gas…/DLCO… and wait until the procedure is completed.

Print the calibration report

In the Calibration program choose Print from the File menu.

Edit the calibration factors

The last sensors calibration factors can be either edited or viewed. To do this choose Gas Results… from the File menu.

To view or edit the last Turbine calibration factor choose Turbine results… from the File menu.

Note: To restore factory setting press Default button in the dialog box. Once you press the default button you must run a new calibration before testing.

O2 delay check

Selecting Calibration/Gas/O 250ms, please contact the Technical Support.

An high value of the O

• Chemical sensor exhausted.

• Old or obstructed Permapure tube.

• Dust or dirt in the sampling line.

delay, check if this value is below 250ms. If it is above

delay can be due to:

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Turbine calibration

The system uses a turbine flowmeter. It opposes a very low resistance to flow (<0,7 cmH motion which causes the rotation of the turbine rotor.

The rolling blade interrupts the infrared light beamed by the three diodes of the optoelectronic reader. Every interruption represents 1/6 turn of the rotor, this allows to measure the number of turn in the time. There is a constant ratio between air passing through the turbine and number of turns. This allows an accurate measure of flows and volume. The turbine flowmeter doesn't need daily calibrations as it is not affected by pressure, humidity and temperature.

To work properly, the turbine only requires the rotor to rotate freely without any friction that might be caused by dust that can be easily avoided with an ordinary cleaning procedure (see Maintenance).

However in order to ensure accuracy it's recommended to run periodically the calibration procedure. Calibration has to be carried out with a calibration syringe of 3 litres volume, the calibration procedure is totally managed by software.

A measurement system should be calibrated daily in order to ensure maximum accuracy and reliable test results. If a correct maintenance is provided it’s possible to check the calibration of the turbine flowmeter even at relatively long intervals (i.e. 1 month). The calibration procedure assures valid and verifiable results within a ±3% accuracy.

O/l/s to 12 l/s). The air passing through the helical conveyors, takes a spiral

The calibration syringe

The 3 litres calibrated syringe is included in all the Quark PFT line with the exclusion of the PFT 1 model.

3 litres calibration syringe: P/N C00600-01-11.

Assembling the flowmeter for calibration

1. Connect the Opto-reader to the calibration syringe through the adapter. Do not use the breathing valve.

2. Connect the flowmeter to the syringe with the rubber cylinder supplied in the standard packaging.

Note: If a bacterial filter is used for the tests, do use it also during the turbine calibration.

Chapter 4 - Calibration - 47

Calibrating the turbine



Note: if you are using a slow PC, we recommend to set

her refresh time.

an hi

After having run the calibration program:

1. Select Reference Values from the File menu. If your syringe has a different value

2. Select Calibration/Turbine….

3. When the Calibration Turbine dialog box appears with the syringe piston initially

from the default one (3 litres), please enter the correct value.

pushed all the way in, move the piston in and out for 5 inspiratory strokes and 5 expiratory strokes in order to get the first values appearing on the display. Then move the syringe piston for other 10 strokes (IN and EX).

4. At each of the 10 steps the software displays the results of the manoeuvre and the percentage error in the reading.

5. At the end of this operation, the software displays the new calibration factors. Press OK to store the new value.

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Checking the system signals

The control panel

The Control Panel, which can be activated from the Calibration/Control panel… menu item, is a useful tool to check the main hardware functions of Quark PFT.

By using the controls on Control Panel you are able to do the following:

1. Reading the signals acquired by the system both as voltages and processed data;

2. Activating/Disactivating the valves, the sampling pump and other installed components (for example, oxymeter).

Using the control panel

Sampling

flow rate

Sampling

pump

mV / real values

display

valve air valve

Analog

input

Apnoea valve

Breathing

Calibration

valve

Deselect all

channels

Oxymeter

Air valve for

DLCO

On/off cylinders

On/Off infrared

sources

HW zero trimmer

adjystment

sensor

range

Signal refresh

time

Select all channels

Chapter 4 - Calibration - 49

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Database

Management

Spirometry patient's database

The Patients database consists of a Patient Card, a Visit Card and a Test Card in which are listed all tests performed by the patient.

Select Archive Navigator from the File menu or press the button by side.



Note: after having deleted a record (patient, visit or test), it is recommended to reorganize the archive in order to free disk space.

Patient Card

It collects all the information of a patient (first name, last name, date of birth) which remain the same for each visit. For each patient there is only one Patient Card, which is created the first time the Patient performs a test.

To move within the database use the following buttons:

Move to the first patient in the archive

Move to the previous patient in the archive

Move to the next patient in the archive

Move to the last patient in the archive

Find a patient in the archive

Enter a new patient in the archive

Delete current patient from the archive

Edit the current patient card

Visit Card

It collects all information relative to the visit (diagnosis, visit description...) and to the patient information subject to change between one visit and another (height, weight, smoke). Each patient can be related to several Visit Cards provided they have been created in different days. Before carrying out any spirometric test it is necessary to create a new Visit Card or to open the today’s Visit Card.

To move within the database use the following buttons:

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Move to the first visit in the archive

Move to the previous visit in the archive

Move to the next visit in the archive

Move to the last visit in the archive

Find a visit in the archive

Enter a new visit card in the archive

Delete current visit card from the archive

Edit the current visit card

Test Card

It contains all the information about the test.

To move within the database use the following buttons:

Delete current test from the archive.

Edit the current test

Import/export a Tests card

This function allows to import /export a test card with the respective visit and patient card.

1. Select the patient.

2. Choose the test and press the key by side. All data will be imported/exported in the XPO file format (Cosmed proprietary).

Diagnosis Database

The program allows to manage a diagnosis database, whose records are composed by a diagnosis ID code and a string of text.

The report of the visits can be done either by typing the desired text in the field “Diagnosis” of the Visit Card or, more quickly, retrieving from the diagnosis database the desired one.

If you want to insert, modify or delete a diagnosis from the database select Database Diagnosis... from the File menu.

Chapter 5 - Database Management - 53

Exercise testing patient's database

The exercise testing software uses a different interface for presenting patient information. The patient database allows to:

• Enter a new patient

• Find patient data

• Edit patient data

• Delete patient data.

Select Patients from the File menu.

Enter a new patient

1. Press New to show the Patient dialog box.

2. Enter data of a new patient and press OK button to confirm.

Find a patient

Edit patient data

Delete a patient

Enter a search string into the Find field and press Find to view the data concerning a subject already in the database. You can search for “Last name”, “ID code” or “Progressive”.

Or:

Press List to view the list of patients in the database. Press Next or Previous to view the data corresponding to the next or to the last patient. Press OK to confirm.

The Next and Previous buttons allow to move to the next or the previous patient in the database.

1. Select the patient.

2. Press Modify… in order to edit the patient’s data.

3. Edit the desired values and press OK to confirm.

1. Select the patient to be deleted.

2. Press Delete.

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Archive maintenance

The software allows to manage files selecting Archive from the File menu.

It is advisable to perform the archive reorganisation every month, in order to free space on the hard disk and/or to correct possible errors present within the database.

It is possible also that your have no more hard disk space. So, you have to delete all the data. In this case, it is useful to perform the initialising.

Reorganise the archive

1. Select Reorganize archive from the File menu.

2. Wait for the end of the operation before performing any other function.

Delete the archive

1. Select Initialize Archive from the File menu.

2. Wait for the end of the operation before performing any other function.

Delete a test

To delete an ergometry test, select Test/Delete test.

To delete a spirometry test, press the proper button in the Test Card.

Backup and restore

It is strongly recommended to backup files, a warning message will be displayed monthly. This function allows the user to restore the data if the PC or the HD will not work anymore.

Backup

1. Select Backup archive from the File menu.

2. Selecting the destination path with the Browse key or press New to create a new directory. Press OK to confirm.

3. In the dialog box it will appear an estimate of the number of floppy disks you need in order to back up the archives. Press OK.

Restore

1. Select Restore archive from the File menu.

2. On the Restore dialog box specify the drive source and press OK, a dialog box will appear indicating all data of the backup processed.

Chapter 5 - Database Management - 55

Spirometry Settings

Quark PFT software allows to configure some options selecting Configure from the Option menu.

Graphs

All the graphs visualised and/or printed can be customised in colours and appearance.

1. Select the desired colours of the curves (5 curves max can be overlapped on the same graph).

2. Enable or disable the Grid option.

3. Enable or disable the Show Info Test option.

Serial port

You must select the serial port RS 232 that will be used to connect the Quark PFT with the PC.

To select the serial port, click on the proper COM button (the selected port must be different from the mouse one).

Units of measurements

It is possible to configure the units of measurements, weight and height, for printing and viewing.

To select the units of measurement click on cm/Kg or in/lb according to the desired format.

Using extra fields

The Patient’s database is organised in 3 different cards (Patient card, Visit Card and Test card.) where it is possible to store the information about patients and visits .

Besides the standard information, it is possible to customise some fields (user free fields), entering and labelling measurements coming from other devices.

The customisable free fields are:

• 3 fields in the Patient Card (Patient’s information)

• 3 fields in the Visit Card (information about the visits)

• 3 fields (2 numeric) in the Test card information about Test)

Customise the fields

In the group User free fields type the desired text in the 9 fields available.

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Spirometry

Setting spirometry options

The software allows to configure some options selecting Configure from the Option menu.

Spirometry

Automatic Interpretation

Quark PFT has the function of interpreting each test performed by a patient visualising an automatic diagnosis. The algorithm has been calculated basing on “Lung Function Testing: selection of reference values and interpretative strategies, A.R.R.D. 144/ 1991:1202-1218”.

The automatic diagnosis is calculated at the end of the FVC Test if:

• the automatic diagnosis option is enabled.

• the patient’s anthropometric data allow the calculation of the LLN (Lower Limit of

Normal range).

• at least one FVC test has been performed.

To enable/disable the automatic diagnosis:

1. Click on Enable Automatic Interpretation checkbox to enable or disable the calculation and the visualisation of the automatic interpretation.

2. Select the LLN (Lower Limit of Normal Range) criteria among the ATS (LLN=Pred-0.674*SD), ERS (LLN=Pred-1.647*SD) or 80%Pred (LLN=Pred*0.8) specifications.

Quality control

Quark PFT allows a quality test control. The calculation has been carried out referring to “Spirometry in the Lung Health Study: Methods and Quality Control, A.R.R.D. 1991; 143:1215-1223”. The messages concerning the quality control are shown at the end of the test.

To enable/disable the quality control, click on Enable Quality Control checkbox.

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Parameters manager

The program allows to calculate a huge number of parameters; it is advisable, in order to simplify the analysis of the results, to view, to print and to sort the desired parameters only. Select the menu item Options/Parameters...

View

Move the parameters to view into the Selected parameters list.

Move the parameters to print into the Selected parameters list.

Sort

Drag the parameter up or down with the mouse.

Customise

Add, modify and delete custom parameters.

If it is necessary to restore the default parameters press the button in the left corner of the window to initialise the parameters database.

Predicted values manager

The program contains a preset of predicted equations, but the user is allowed to customise its own predicted sets. Select Predicteds... from Options menu.

The window is divided into two forms: Predicteds set and Formula definition.

Predicteds set

This form allows the user to manage the set of predicteds. The following information define a set:

Chapter 6 - Spirometry - 59

Name: identifies the set and cannot be duplicated;

Description: free field;

Age: the adult predicteds start since this age.

To enter a new set of predicteds click on the New button. The field Name must be filled and must be unique. To stop without saving click on the Cancel button. To save the set, click on the Save button.

To delete a set of predicteds click on the Delete button. If a set is deleted, also the associated formulae are deleted.

It is possible to generate a new set of predicteds with the same attributes and the same formulae of the selected one. To do this click on the Copy... button and specify a new Name.

To import a set of predicteds click on the Import... button and select a file of Predicteds files type.

To export a set of predicteds click on the Export... button.

In the list Set current predicteds choose the current predicteds for printing and viewing.

Set the current predicted

Quark PFT allows to calculate the predicted values according to the following configurable sets:

Adults Paediatrics

ERS 93 Zapletal

Knudson83 Knudson83

ITS white ITS white

ITS black ITS black

LAM LAM

MC Barcelona MC Barcelona

Nhanes III Nhanes III

Select the desired choice in the group Predicted.

Formula definition

This form allows the user to manage the formulae associated to a set of predicteds.

Select the set of predicteds from the list Predicteds set.

To insert a new parameter click on the New... button.

The parameter formulae can be:

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Page set-up

• calculated according to the predicteds in the list Use the predicteds formulae;

• customised by the user with the option ...or the customised formulae.

The Delete button deletes the selected parameter.

The Copy button stores the selected parameter in memory.

The Paste button inserts a new parameter from the one copied. If the name is not unique, the user is asked whether to specify a new name or to replace the existing parameter.

Select Page Setup... from the File menu.

Header All the printouts carried out by the program are preceded by 3

rows of customisable header (usually they contain the name and the address of the Hospital using the spirometer).

Data Patient and visit information are printed below the header.

These data are reported on 3 columns and 5 rows. the user may configure the disposition, change and eventually cancel the fields, as he prefers.

Margins Configures the print margins from the borders of the paper.

The unit of measure is decided in Units of measurements.

Footer Configures information at the bottom of the page.

Printed file name Defines the automatic name to be asssigned to the pdf file, if

the report will be printed in this format.

In the example it has been set to create a filename composed by

<date of the test> followed by <last name> and <first name>.

Chapter 6 - Spirometry - 61

Spirometry tests



Note: Read carefully the contraindications in Chapter 1.

Once completed the phases of the introduction of the patient’s data and the visit data, it is possible to carry out the spirometric tests.

Quark PFT allows to perform the following tests:

Key Test

FVC pre Forced Vital Capacity

FVC post Forced Vital Capacity after bronchial stimulation

SVC Slow Vital Capacity

MVV Maximum Voluntary Ventilation

FRC Nitrogen Wash-out

CV Closing Volume

DLCO CO Diffusing capacity

P0,1 Respiratory Drive

Note: The FVC, SVC and MVV tests must be performed with the flowmeter disconnected from the breathing valve.

Before performing any test make sure that:

1. Quark PFT is properly connected to your PC and the selected serial port (COM1, COM2) corresponds to the one effectively use.

2. The name shown on the status bar corresponds to the patient who is to carrying out the tests.

3. The today’s visit card exists.

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Forced Vital Capacity (pre)

FVC is a reference test to verify obstructive (airflow limitations) and restrictive disorders (lung volume limitations). To achieve good test results it is fundamental a good manoeuvre (quality control messages, real time plots …)

The main parameters measured during FVC tests are:

FVC Forced Vital Capacity

FEV1 Forced Expiratory Volume in 1 second

FEV1/FVC% FEV1 as a percentage of FVC

PEF Peak Expiratory Flow

FEF25-75% Forced mid-Expiratory Flow

The two representative plots are the Flow/Volume and Volume/Time loops.

By comparing FVC, FEV1 and FEV1/FVC% values the software allows an automatic interpretation concerning the levels of obstructive and/or restrictive disorders.

Recommendations

• The flowmeter has to be disconnected from the breathing valve

• The patient should wear the nose clips

• The turbine has been recently calibrated (ATS recommends a daily calibration)

• The paper mouthpiece or the antibacterial filter is properly connected to the

flowmeter through the corresponding adapter

For hygienic reasons, we strongly recommend the use of a bacterial filter.

If a kid must perform the test it is recommended to enable the encouragement function which shows exactly the manoeuvre of the FVC test.

Perform a FVC (pre) test

1. Select Forced Vital Capacity pre from the Test menu and wait for the green led is

2. Explain the manoeuvre to the patient and press the F2 key.

3. Wait some seconds and perform the test.

4. After having performed the test, press F3 or wait for the automatic end (5 seconds

5. In order to visualise the F/V and V/t graph and the main parameters press the

6. Press Alt+F3 to stop the acquisition discarding the results.

7. Repeat the test until it is correctly performed (ATS recommends 3 times).

8. Press Exit to visualise the test list carried out during current session together with

9. Select the test that you want to save (the Best Test according to the ATS criteria is

prompted on the right side of the screen.

without flow), so that the software displays the F/V and V/t graphs, the main parameters, and the predicteds values.

following buttons:

view Flow Volume graph

view Volume Time graph

view data of the test

the results of the main parameters.

highlighted as default) and press OK.

Test encouragement

During FVC manoeuvre you might experience some lack of collaboration with kids or with other patients. In this case you may find a good help in using the encouragement software tool.

Chapter 6 - Spirometry - 63

Perform the FVC test with the encouragement

1. Select Encouragement from View menu.

2. Perform the test as explained in the previous paragraph.

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Slow Vital Capacity

Important test for assessing COPD (chronic obstructive pulmonary disease) patients affected by this disease might present a the Slow Vital Capacity could be higher than the Forced one (FVC).

The main parameters measured during SVC tests are:

EVC Expiratory Slow Vital Capacity

IVC Inspiratory Slow Vital Capacity

ERV Expiratory Reserve Volume

IRV Inspiratory Reserve Volume

If the inspiratory/expiratory maximal manoeuvre is preceded by a some breaths at tidal volume the software allows to measure the Respiratory Pattern, represented by the following parameters:

VE Ventilation per minute

Vt Tidal volume

Rf Respiratory frequency

Ttot Breath time

Ti/Ttot Inspiratory time/Ttot

Vt/Ti Vt/Ti

Perform a SVC test

1. Select Slow Vital Capacity from the Test menu and wait for the green led is prompted on the right side of the screen.

2. Press F2 and instruct the Patient to breath normally until the message “carry out…” is prompted; then ask to perform a Slow Vital Capacity (deep inhalation, maximal slow expiration and deep inhalation again).

3. Press F3 or wait for automatic interruption (5 seconds without flow) in order to visualise the V/t graph together with the main parameters compared to the predicted values

4. To visualise the V/t graph and the main parameters press the follow buttons:

view Volume Time graph

view data of the test

5. Press Alt+F3 to stop the acquisition discarding the results.

6. Repeat the test until it is correctly performed (ATS recommends 3 times).

7. Press Exit to visualise the test list carried out during current session together with the results of the main parameters.

8. Select the test that you want to save (the Best Test according to the ATS criteria is highlighted by default) and press OK.

The reference for the ERV calculation is displayed on the V/T graph.

Chapter 6 - Spirometry - 65

Maximum Voluntary Ventilation

Test for assessing the maximum ventilatory capacity. In the past, it was commonly performed during routine PF tests, however its clinical use declined over the years. Today MVV test is most commonly performed as part of the exercise tolerance tests, where it is used as an index of maximum ventilatory capacity. Test consists in breathing in and out deeply and rapidly for 12, 15 seconds. The expired volume during this short period is then extrapolated

The most important measured parameter is the following:

MVV Maximum Voluntary Ventilation

Perform a MVV test

1. Select Maximum Voluntary Ventilation from the test menu and wait for the green led is prompted on the right side of the screen.

2. Press F2 and make the Patient breath as much deeply and rapidly as possible for at least 12 seconds.

3. Press F3 or wait for automatic interruption (5 seconds without flow) in order to visualise the V/t graph together with the main parameters compared to the predicted values

4. To visualise the V/t graph and the main parameters press the follow buttons:

view Volume Time graph

view data of the test

5. Press Alt+F3 to stop the acquisition discarding the results.

6. Repeat the test until it is correctly performed (ATS recommends 3 times).

7. Press Exit to visualise the test list carried out during current session together with the results of the main parameters.

8. Select the test that you want to save (the Best Test according to the ATS criteria is highlighted as default) and press OK.

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Bronchial Provocation Test

Bronchodilator test



Note: Read carefully the contraindications in Chapter 1.

Bronchodilators are administered routinely in the PFT laboratory to determine whether airflow obstruction is reversible. Bronchodilators increase airway calibre by relaxing airway smooth muscle.

The test consists of comparing results between the reference FVC (FVC PRE) and the FVC POST performed after the administration of the drug. Increasing value of 13-15% of FEV1, respect to the basal value (FVC Pre) is considered as a reversible condition.

Main parameters are the following:

DFEV1%pre Change of FEV1 as a percentage of test PRE

DFVC%pre Change of FVC as a percentage of test PRE

DPEF%pre Change of PEF as a percentage of test PRE

Some authors states that the above mentioned parameters are too dependent from the FVC Pre, hence latest reference (ERS93, [A comparison of six different ways of expressing the bronchodilating response in asthma and COPD; reproducibility and dependence of pre bronchodilator FEV1: E. Dompeling, C.P. van Schayck et Al; ERJ 1992, 5, 975-981]) recommend the following parameters:

DFEV1%pred Change of FVC as a percentage of predicted value

DFEV1%poss Change of FEV1 as a percentage of “possible value”

Methacholine and Histamine Bronchial provocation Tests

The most common indication for performing methacholine and histamine bronchial challenges is to diagnose hyperresponsive airways. Some patients demonstrate normal baseline pulmonary function despite complaints of “tightness” wheezing, cough, and a little or not response to bronchodilator. Other patients demonstrate spirometric improvement after use of bronchodilator have diurnal variation in peak flows. In this groups aerosolised bronchial challenges are used to confirm a diagnosis of Asthma.

We can summarise the use of the test as follows:

1. Diagnose asthma

2. Confirm a diagnosis of asthma

3. Document the severity of hyperresponsivness

4. Follow changes in hyperresponsivness

When patients with hyperresponsive airways inhale certain pharmacologic agents (i.e. Methacholine or histamine) the airways respond by constricting.

Test consists of executing repeated FVC following the pharmacologic agents inhalation according to an established protocol. The fall of the FEV1 parameter is used to calculate the bronchial hyperresponsivness. The most important parameter is the PD20 that is amount of drug (mg/ml) that causes a reduction of 20% of the FEV1 respect the basal value (without drug).

Main parameters are:

P10 Dose that causes a 10% fall of FEV1.

P15 Dose that causes a 15% fall of FEV1.

P20 Dose that causes a 20% fall of FEV1.

The representative plot is the Dose/response curve, showing the percentage variation of FEV1 versus the Drug dose in logarithmic scale.

The program assumes as the baseline test the best FVC pre carried out during the today’s visit. You can change the reference pre test editing the Post test.

The name of the drug, its quantity and its unit of measurement, can be typed immediately before any FVC post manoeuvre (manual protocol) or can be stored in a database of bronchoprovocation (File/Bronchial Provocation protocols Database…).

Chapter 6 - Spirometry - 67

Perform the test

(During 1st step only) select Protocol... from the Test menu and choose the name of the bronchoprovocation protocol that you are going to use (manual protocol if you want to type the information about the agent before any manoeuvre)

1. Select FVC post from the Test menu.

2. Select an existing protocol or click on “manual protocol”, and wait the green leds turned on.

3. Press F2, or the button by side, to start the test.

4. Press F3, or the button by side, to achieve the test.

5. In order to visualise the V/t graph and the main parameters press the follow buttons:

view Flow Volume graph

view data of the test

view bronchial provocation response

6. Press Alt+F3 to stop the acquisition discarding the results.

7. Repeat the test until it is correctly performed (ATS recommends 3 times).

8. Press Exit to visualise the test list carried out during current session together with the results of the main parameters.

9. Select the test that you want to save (the Best Test according to the ATS criteria is highlighted as default) and press OK.

Bronchial Provocation protocols Database

The response to a bronchoprovocator is usually assessed in terms of change in the FEV1, vital capacity or airways resistance on the basis of serial measurements (FVC manoeuvres) in which the results of the initial test constitute the reference values. The international literature proposes several standardised protocols in order to address the methodological issues of the various available techniques.

The possibility to store a bronchoprovocation protocol in a database is useful to simplify and automate the sequence of operations that the Physician need to execute during the bronchoprovocation tests.

The typical sequence of activities to carry out a bronchoprovocation test are:

1. Typing and storing a bronchoprovocation protocol in the database (usually only once).

2. Selection of protocol among the list of the ones already present in the database before carrying out the FVC post tests (the selection of “manual protocol” allows to execute the test fully manually).

3. Performing the Post tests.

Enter a new Bronchial provocation protocol in the archive

1. Select Bronchoprov. protocols database from the File menu.

2. Type the Protocol name, the Bronchoprovocator name and the unit of measurement in the proper input fields.

3. If the bronchoprovocator has a cumulative effect select the cumulative check button.

4. Enter the quantities for each step and press the button

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Viewing results

All the visualisation functions refer to the test carried out by the Current Patient, whose name is indicated on the left-side of the status bar.

To view tests results:

1. Select the Patients from the File menu

2. Select the patient corresponding to the test you want to view.

3. Select in the list box of the tests up to 5 tests of the kind (FVC, VC/IVC, or MVV) and press OK.

To switch between graph and or data use the following buttons on the toolbar:

view Flow Volume graph (F5)

view Volume Time graph (F6)

view data of the test (F7)

view bronchial provocation response.

If you need more than one visualisation meantime use the New Window function from the Window menu.

If you need to display a list of visits:

• Select Visits list... from the File menu.

• Type the name of the Company and/or the time interval desired or simply confirm

for the complete list.

Tests of the current patient

If a current patient has been selected you can quickly view his tests selecting Test current patient... from the View menu.

Delete a test

1. Select Patients from the File menu or press the button by side.

2. Select the test that you want to eliminate from the list of the tests referred to the Current Patient and press Delete.

Chapter 6 - Spirometry - 69

Printing results

Printing Reports

You can print out in three different ways:

• printing the Report

• printing the Active Window

• printing a series of reports

To print a report of the current visit, select Print report… from File menu. The software will choose automatically the best performed test.

The standard Report is composed by 1, 2 or 3 pages depending if you wish to printout the FVC data and the graphs together on the first page or if you wish to printout the bronchoprovocation response.

• Selecting the option One page (no ATS) the report will contain, on one page, the F/V and V/t graphs of the best test, overlapped on the FVC Post, the patient data, the notes, the diagnosis and the test results.

• Otherwise the report will contain two pages, the first with the patient data, the graphs and the diagnosis, and the second one with the measured parameters, according to the ATS recommendations.

• The 3

page will contain the bronchoprovocation response.

Select the desired options:

FVC graph Prints the F/V and V/t curves for the best FVC test.

One page (no ATS) Prints data and graphs on the first page.

Response Prints the bronchoprovocator response.

FVC post Prints data and graphs for the Post FVC test (the test can be

selected among the test performed in the current visit).

Multi breath N

Prints the best FRC test of the current visit.

wash out

Single breath O

Prints the best CV test of the current visit.

Single breath CO Prints the best DLCO with apnoea test of the current visit. diffusing capacity

Single breath CO Prints the best DLCO without apnoea test of the current visit (no breath hold)

CO diffusing capacity Prints the best DLCO Steady State test of the current visit Steady State

Respiratory drive Prints the best P0,1 test of the current visit.

Preview Views a report preview on the screen.

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Printing the active window

This printout function is only enabled when the active window (title bar highlighted) is one of the following objects:

• Any kind of Graph.

• Numeric data

• List of visit

To print the active window

1. Ensure that the active window is one of the preceding objects.

2. Select Print Active window from File menu.

Printing a series of reports

Sometimes it is useful to printout automatically a series of reports (all tests carried out with the employees, all tests carried out in the today's session).

To print out proceed as follows:

1. Select Visit List from the File menu

2. Set the criteria of the visits to be added in the list (from, to,...)

3. Select Print Report from the File menu.

Electronic reports (*.pdf)

If an Adobe PDF writer “Printer Driver” is installed and set as the default printer, it is possible to store the printout report automatically in any location of the HD or eventually LAN paths according to a customizable filename format.

It is possible to define the created filename format selecting File/Page Set up... (see Page set-up).

Export data

With this function you can export the test data in 4 different formats:

• *.txt (ASCII)

• *.xls (Microsoft Excel)

• *.wk1 (Lotus 123)

• *.xpo (Cosmed)

Export a test

1. Select Export tests from the File menu.

2. Select the test to export from the list box and press OK.

3. Type the name and the format of the file in the dialog Save as. If the ASCII format is selected, the Text button in the dialog box Save as allows you to configure the separators for character based files.

With the *.xpo Cosmed file format it is possible to import data from another Quark

archive. Press OK to confirm.

4. Select the folder for the export and type the file name. Press OK to confirm. A status bar will show the file creation.

Chapter 6 - Spirometry - 71

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Lung Volumes

Lung volumes tests (N2 washout)

In the PFT lab the measurement of “Lung Volumes” usually refers to the measurement of Total Lung Capacity (TLC), residual volume (RV), functional residual capacity (FRC), and Vital Capacity (VC). These measurements are essential to assess lung function, they are important for the diagnosis of restrictive disorders.

FRC is most commonly determined with one of three basic techniques:

1. Multiple-breath open circuit Nitrogen washout

2. Body Plethysmography

3. Multiple-breath closed circuit Helium washout

COSMED Quark PFT uses the nitrogen wash-out technique to measure Lung volumes. This method involves removing or “washing-out” the N2 gas present in a patient’s lung by having the patient breathe 100% O2 for several minutes (usually 7 minutes or until the final concentration of N2 is below 1.5-2.5%). Since the whole expired nitrogen come from the initial lung volume, a simple equation allows to get FRC value.

The main parameters measured during this test are:

FRC Functional Residual Capacity

CEV Total ventilated volume during the test

Wash-out time Test duration

RV Residual Volume

TLC Total Lung Capacity

RV/TLC Motley index

Recommendations

• The system must be calibrated before each test (See Calibration chapter)

• The flowmeter must be connected properly to the breathing valve and the soft

mouthpiece must be properly fixed to the corresponding adapter.

• Check that the O 6 bar.

Setting N2 wash-out options

1. Select Settings... from Options menu.

2. Select Multi-breath N

3. Set the desired value in all the fields described in the next table.

cylinder is open and its output pressure is adjusted in the range 5-

Wash-out

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Perform the test

Option Description

End-of-test criterion FetN

value under which the wash-out test is concluded

automatically

FRC Extrapolating Enable the extrapolation of FetN

to the end-of-test

criterion

Vt stability threshold Recognition criterion of regular respiration

Breathing Depth Range of respiration control bar during FRC (tidal

volume)

Breathing Frequency Range of respiration control bar during FRC

(respiratory frequency).

Pressing the System… button, you can set the following options:

Option Description

System dead space Add the volume of the viral filter eventually used

O2 cylinder impurities Refer to the used O2 cylinder analysis certification

1. Select Multi-Breath N

wash-out from the Test menu and wait for the green led is

prompted on the right side of the screen.

2. Connect the patient to the breathing valve and invite him/her to breathe normally.

3. Wait for the message “carry out slow vital capacity” is prompted on the screen of the PC and let the patient to perform a slow vital capacity.

4. Wait for a normal breathing pattern is again established and press Start (F2) to begin the wash-out with oxygen.

5. Wait for the final Nitrogen concentration (FetN

) reaches a value lower than 2.5%

and press Stop (F3) to conclude the test.

6. In order to visualise the graph and the main parameters press the follow buttons:

view FRC graph

view Volume Time graph

view data of the test

view breath by breath data

At the end of the test, you can edit the test:

• Display the test to be modified

• Right click with the mouse and select Edit...to change the test properties (wash-out

volume, sample volume, effective breath hold time calculation...).

Chapter 7 - Lung volumes - 75

Closing Volume Test (CV)

The Patient perform one single inspiration of 100% O2 following a maximal expiration (RV level) and then expires smoothly through a breathing system able to measure both the instantaneous N

The expired nitrogen is plotted on a N obtained. The graph presents 4 different phases:

Phase I: The gas expired during Phase I represents the oxygen coming from the

dead volume of the measurement system and the upper airways not interested by any distribution phenomenon.

Phase II: Shows the N

airways and the alveolar volume where the initial N the inspired oxygen. In this phase the Anatomic Dead Space is calculated (Fowler method).

Phase III: It is called Alveolar Plateau. It shows the average N

resulting from the dilution of the air originally contained in the Residual Volume with the inspired Oxygen. The slope of this plateau (about 1.5% for normal subjects) is an useful index for assessing distribution disorders (Patients affected by severe emphysema can reach 10% values).

Phase IV: The end of Phase III corresponds to the beginning of the so called

Closing Volume which represents the last section of the Vital Capacity

before the Residual Volume. The quick increase of the N2% belongs to the emptying of the latest alveoli, richest of N inspired O

The main parameters calculated during this test are:

CV Closing Volume

Delta N

% Delta N

concentration and expired flow.

/Volume graph from which test results are

% rising belonging to the spaces connecting the upper

has be diluted with

because not reached by the

. Increased values of CV can be related to lung pathologies.

% between 750ml and 1250ml of expiration.

concentration

Perform the test

Recommendations

• The system must be calibrated before each test (See Calibration chapter)

• The flowmeter must be connected properly to the breathing valve and the soft

mouthpiece must be properly fixed to the corresponding adapter.

• Check that the O

cylinder is open and its output pressure is adjusted in the range 5-

6 bar.

1. Select Single Breath O

from the Test menu and wait for the green led is prompted

on the right side of the screen.

2. Connect the patient to the breathing valve and invite him/her to breathe normally.

3. Wait for the message “carry out Slow Vital Capacity” is prompted on the screen of the PC and let the patient to perform a slow vital capacity.

4. Wait for a normal breathing pattern is again established and press Start (F2) during a maximal exhalation.

5. Ask him/her to inspire up to TLC level and then to expire slowly maintaining the flow rate as much constant as possible (two lines corresponding to 250ml/min and 500ml/min can be used as a target interval).

On the right side of the graph it is displayed a colored column, representing the

instantaneous flow. This column is green if the flow is within the acceptable range, otherwise it is red.

6. The test stops automatically.

7. In order to visualise the graph and the main parameters press the follow buttons:

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View CV graph.

view Volume Time graph

view data of the test

At the end of the test, you can edit the test:

• Display the test to be modified

• Right click with the mouse and select Edit...to change the test properties (wash-out

volume, sample volume, effective breath hold time calculation...).

Chapter 7 - Lung volumes - 77

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P0.1 Respiratory

drive

P0,1 (Respiratory drive)

Aim of the test

The test named P0,1 or Respiratory Drive consists of evaluating the reduction of pressure caused by the patient's inhalation.

In order to evaluate the P0,1 the subjects breaths in a mouthpiece provided with a shutter and a pressure detector, by determining a shut down of the respiratory ways for 100 msec at the beginning of the inhalation, its possible to measure the reduction of pressure. The shut down is so short that the patient keeps breathing normally without realising it. Many other measurement can be carried out making the patient inhale increasing concentration of CO

Setting respiratory drive options

1. Select Settings... from Options menu.

2. Select Respiratory drive

3. Set the desired value in all the fields described in the next table.

and verifying the results.

Option Description

Vt Stability threshold Recognition criterion of regular respiration

Recommendations

• Connect the P0.1 valve on the “breathing valve” connector on the front panel of the

• Verify that the cylinder driving the P0.1 valve (O

Perform the test

1. Select Respiratory Drive from the Test menu and wait for the green led is

2. Breath at rest until the message “Press F2...” is prompted.

3. Wait for the Patient establish a regular breathing pattern and press F2 whenever

4. Repeat the above mentioned manoeuvre several time both in room air or with

5. Press F3 to end the test.

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Quark system.

-CO2) is open.

prompted on the right side of the screen.

you want to close the inspiratory valve for measuring the P0.1 parameter.

enhanced CO

inspiratory gas.

6. To visualise the V/t graph and the main parameters press the follow buttons:

view P0.1 graph

view Volume Time graph

view breath by breath data

7. Press the Abort button to stop the acquisition discarding the results.

Chapter 8 - P0.1 Respiratory drive - 81

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Lung diffusing

capacity

CO Diffusing Capacity (DLCO) Test

The process of diffusion is defined as the flow of particles from an area of higher concentration to an area of lower concentration. The measurement of diffusion, as performed in pulmonary function laboratories, provides information about the transfer of gas between the alveoli and the pulmonary capillary blood. The two major gases involved in lung diffusion (O capillary membrane and the blood plasma-red blood cell barrier.

The rate of diffusion across these primarily liquid barriers is limited by the surface area for diffusion, the distance the gas molecules must travel, the solubility coefficient of the gases in the liquid, the partial pressure difference (gradient) between air and blood and the density of each gas.

Measurements of the diffusing capacity is usually performed using Carbon Monoxide (CO) because it has a great affinity for Haemoglobin (210 times that of O in blood and its concentration in venous blood is insignificant.

The main techniques are:

1. Single Breath with Apnoea (ATS/ERS standard)

2. Single Breath without Apnoea (requires a fast response CO analyser)

3. Multiple Breath in Steady-State

Setting DLCO options

1. Select Settings... from Options menu.

2. Select Single Breath CO diffusing capacity

3. Set the desired value in all the fields described in the next table.

and CO2) must move through two barriers: the alveolar-

), it is soluble

Option Description

Apnoea time ATS and ERS standard: 10 s

Effective time Ogilvie

Vt Stability threshold Recognition criterion of regular respiration

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, Jones & Meade2, ESP3

from the beginning of the inspiration till the beginning of sampling

from 70% of inspiratory time, to 50% of sampling

from 50% of Inspired Volume to the beginning of sampling

Pressing the System… button, you can set the following options:

Option Description

System dead space Add the volume of the viral filter eventually used

concentration O2 content of the used mixture (ATS 21%, ERS

Pressing the Patient… button, you can set the following options:

Option Description

Physiologic dead space calculation criterion (ATS=2.2*weight, manual)

Haemoglobin calculation criterion (ATS=14.6 adult men, 13.4

Carboxyhaemoglobin digit the percentage value

Recommendations

• The system must be calibrated before each test (See Calibration chapter)

• The flowmeter must be connected properly to the breathing valve and the soft

mouthpiece must be properly fixed to the corresponding adapter.

• Check that the DLCO cylinder is open and its output pressure is adjusted in the range 5-6 bar.

DLCO with breath-hold (standard technique)

The Patient carry out a maximal inspiration of a mixture containing a low concentration of CO (0.3%) and a tracer gas which is not metabolised (CH asked to breath hold for 10 seconds (the expiratory valve is kept closed) and finally he is allowed to expire slowly up to the Residual Volume (the expiratory valve is opened).

Analysing the concentrations of CO and the Tracer gas (CH the expired volume (collected volume) obtained by discarding the beginning of the expiration (wash-out volume), the test indexes are determined.

The “wash-out volume” (0.75-1 L for normal subjects, 0.25-0.5 L with reduced Vital Capacity ), the “collected volume” (0.5-1 L) and the calculation of the “breath hold time” (ESP, JONES, OGILVIE) have been standardised by both ATS and ERS.

If fast response CO and CH the “wash-out” and “collected” volumes according to the Vital Capacity of the subject. This is usually achieved operating graphically on the CO/CH

Repeating the DLCO test with different mixtures of inhaled gas it is possible to separates the contributes of the alveolar membrane (Dm) and the Capillary Blood Volume (Vc)

The main parameters of the DLCO test are:

DLCO Lung Diffusing Capacity

DLCOcorr Lung Diffusing Capacity corrected for Hb, COHb and PB

VA Alveolar Volume

DLCO/VA Krogh Index

Dm Alveolar Membrane

Vc Capillary Blood Volume

analysers are used it is possible to optimise the selection of

17%)

women and children)

, Methane); then he is

) belonging to a portion of

graphs.

DLCO with apnoea (standard method)

1. Remove the sampling line from the flowmeter

2. Select Single Breath CO diffusing capacity from the Test menu

3. Confirm or in case change the test options:

- Breath hold time

- Simulated test (it allows to carry out the manoeuvre without inhaling gas, useful for teaching purposes)

- Hb (haemoglobin)

- Anatomic dead space

Chapter 9 - Lung diffusing capacity - 85

4. Wait for the zeroing of the analyser is completed and plug in again the sampling line in the flowmeter

5. Connect the Patient to the mouthpiece and let her/him breathing at rest until the message “Carry out Vital Capacity” is prompted

6. Carry out a Slow Vital Capacity if desired (this is not necessary for completing the DLCO test)

7. Invite the Patient to exhale up to Residual Volume and press F2 during the maximal expiration

8. Coach the Patient to inhale up to Total Lung Capacity and to hold the breath until the expiratory valve will be automatically open; a quick full expiration shall follow and the test will be completed.

A dashed line indicates the 90% of the Best Vital Capacity (if a FVC or SVC test is available in the archive, otherwise it indicates the 90% of the Predicted VC), in order to verify the correctness of the manoeuvre.

Double-click with the left mouse button in order to modify the test options (wash-out volume, sampling volume, calculation of the real apnoea time…). Checking the box ATS95 Criteria, it is possible to set automatically 1 litre for wash-out and sampling values, according to the ATS95 criteria.

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DLCO without apnoea (“intrabreath” method)

1. Remove the sampling line from the flowmeter

2. Select Single Breath CO diffusing capacity from the Test menu

3. Confirm or in case change the test options:

- Breath hold time (deselect the check box)

- Simulated test (it allows to carry out the manoeuvre without inhaling gas, useful for teaching purposes)

- Hb (haemoglobin)

- Anatomic dead space

4. Wait for the zeroing of the analyser is completed and plug in again the sampling line in the flowmeter

5. Connect the Patient to the mouthpiece and let her/him breathing at rest until the message “Carry out Vital Capacity” is prompted

6. Carry out a Slow Vital Capacity if desired (this is not necessary for completing the DLCO test)

7. Invite the Patient to exhale up to Residual Volume and press F2 during the maximal expiration

8. Coach the Patient to inhale up to Total Lung Capacity and to expire slowly maintaining the flow rates within the two target lines shown on the real-time window until the Vital Capacity has been exhaled.

Double-click with the left mouse button in order to modify the test options (wash-out volume, sampling volume, calculation of the real apnoea time…).

Multiple breath DLCO test (“Steady-State” method)

In this test, the patient breathes regularly during the whole test (about 8 min): graphs and results will be displayed breath by breath.

Normally, during the first 2 minutes the patient inhales ambient air, then such a mixture:

0.1% CO, 0.1% CH4, 21% O2, N2 balance.

1. Remove the sampling line from the flowmeter

2. Select CO diffusing capacity steady state from the Test menu

4. Wait for the zeroing of the analyser is completed and plug in again the sampling line in the flowmeter

5. Connect the Patient to the mouthpiece and let her/him breathing at rest until the message “Carry out Vital Capacity” is prompted

6. Carry out a Slow Vital Capacity if desired (this is not necessary for completing the DLCO test)

7. While the patient is exhaling, press F2 in order to start the mixture

8. When the steady state is reached, press F3 to end the test.

Right-clicking you can generate new graphs and parameters to be displayed, both during the test and at the end.

Chapter 9 - Lung diffusing capacity - 87

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MIP/MEP (option)

MIP/MEP test

The MIP/MEP test measures the maximum inspiratory/expiratory pressure of the patient. He/She breathes normally until the start of the test, perform a maximal expiration/inspiration and then inspires/expires with the maximum force against a valve which does not allow the air flow.

The measured parameters are:

MIP Maximum inspiratory pressure

MEP Maximum expiratory pressure

How to perform the test

1. Disconnect the breathing valve from the front panel of the Quark

2. Connect the MIP/MEP valve to the breathing valve connector on the front panel of

3. Select MIP/MEP from Test menu and wait for the green led is prompted on the

4. Breathe normally for some time.

5. Carry out a maximal expiration (for the MIP) or a maximal inspiration (for the

6. Press F2 during the expiration/inspiration.

7. Inspire/Expire with the maximum force against the shutter until it opens

8. Repeat the same procedure for the expiratory (inspiratory) maneuver. It is not

9. Press F3 or wait the end of the test, so that the software displays the graphs, the

the Quark and insert the flowmeter into the valve. Use a rubber mouthpiece connected to the antibacterial filter and nose clip.

right side of the screen.

MEP).

automatically.

necessary to repeat the test since both MEP and MIP can be conducted during the same acquisition.

measured parameters, and the predicteds values.

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Pulse oximetry

(option)

The oximetry test

The oximetry test measures the haemoglobin saturation, i.e. the percentage of the blood haemoglobin bearing oxygen. The test can be performed at rest or during/after a light exercise phase (cycling, jogging).

This test is not intended for measuring the oximetry during exercise tests. For this use, see chapter Exercise testing.

The test is completely automatic.

The measured parameters are:

SpO

HR Heart rate

How to perform the test

1. Connect the pulse oximeter to auxiliary RS232 port on the back of the Quark PFT.

2. Connect the probe to finger or ear of the Patient (different probes are available).

3. Select Oximetry from the Test menu and wait for the green led is prompted on the

4. In the first part of the test the HR and SpO

Haemoglobin saturation

right side of the screen.

values, together with a

plethysmographic graph, are displayed. The graph monitors the quality of the signal.

5. Wait for an acceptable quality of the real-time trace and press F2 or the Start button to start the data acquisition.

6. Every 5 seconds, the HR and SpO

values are stored.

7. After the test, press F3, so that the software displays the graphs and the measured parameters.

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Exercise testing

Recommendations for the exercise testing

The evaluation of the cardiorespiratory function

The physical training requires the interaction of physiological mechanisms that allow the cardiovascular and respiratory systems to supply the increasing demand of energy due to the contraction of the muscles.

During the training the systems are both engaged, an adequate answer to the effort is the measure of theirs health state.

The increase of the metabolic rate, during the exercise, needs an appropriate increase of oxygen in the muscles. At the same time, the CO

in order to avoid the lactic acid making.

To satisfy the increase in the gas exchange, necessary to the muscles during the exercise, is requested the intervention of many physiological mechanisms. This process involves lungs, the pulmonary circulation, the heart and the peripheral circulation.

Precautions

The physician has the responsibility that the patient subjects to the test is a suitable person able to execute an effort test.

Laboratory

The room, in which the test is performed, must be big enough to contain the whole necessary equipment, allowing an easier accessibility to the patient in case of emergency.

In the room should be placed a thermometer and a hygrometer; the heart frequency and the perceived values of the effort rise as much as the ambient temperature increases, and the variability of the cardiovascular response grows for humidity values higher of 60%. Generally it is considered 22°C the temperature adequate for the test execution, even for short efforts, values till 26°C can be considered acceptable in presence of an efficient air ventilation.

muscles production must be removed

Ending the test

The patient should be monitored with ECG for at least 8 minutes, in resting conditions or until he returns to the pre-exercise conditions.

Preparing the patient

To enhance the value of a diagnostic test it’s very important patient collaboration. In most cases a well-informed patient will make a better effort (in relation to his conditions) and will allow a reliable interpretation of the test. For this reason every ergometric test must be preceded from a precise training of the patient.

Before testing

The physician applying the exam must be provided with a written request including a brief description of the diagnosis (confirmed or suspected ), the request’s reason and the patient therapy carried out showing the dose and time of the drug assumption.

To standardise the response to the test and reduce the patient’s anxiety it’s suggested to provide him either written (before the exam) or oral (at the same time of the test) information. At the scheduling time detailed instructions should be delivered to the patient, consisting in smoke and food abstinence three hours before an ergometric test, or eight hours before a scintigraphic test.

Test are usually executed supporting the therapeutic outline in progress, but sometimes it could be necessary to stop some drugs, such as b-block or calcium antagonist, which could impair the effort response reducing the diagnostic accuracy of the exam.

The patient must wear comfortable suit and gymnastic shoes and two hours before test stop any kind of drugs, eat light and avoid coffee and smoke.

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It’s very important acquire information on the patient’s clinical past before performing the test. Keep attention in particular way to the use of drugs, tobacco, to the physical fitness and symptoms produced with the exercise.

Patient assent

The patient is informed that he will be submitted to a maximum effort, which could be stopped at any moment, and of the risks of the test execution.

Ending the test

Test may end when the maximum value of the oxygen consumption has been reached and the patient’s response established.

Chapter 12 - Exercise Testing - 95

Start Testing



Note: Selecting “Simulated test”, the software allows to use the gas calibration in order to perform the test. This is useful if the user would check the accuracy of gas measurements.

Before starting exercise test type a new patient information or choose one from the list of patient in the file. As soon as a patient has been entered the software is ready to start a test. The name of the active patient is shown on the status bar of the program window.

Start a test

1. Calibrate the analysers as described in the Calibration chapter.

2. Choose Execute Test from the Test menu.

3. Enter or modify the antropometric data of the patient and select the options you

4. Select the ergometer you need to control

5. The software environment will change showing a new Menu bar and toolbar while

6. At this point the software starts showing data on the monitor but without saving

Abort the test without saving data

Choose Abort from the Test menu or press Alt+F3.

End the test saving data

1. Choose End from the Test menu or press F3.

2. Choose Yes to end the test or No to continue.

View data in real-time

The visualisation features and capabilities of the data and graphs are identical to the ones described in the Data management chapter. Starting the test a small window will appear on the right corner displaying time, bmp and, if selected before, the ergo protocol and trainer.

need to carry out the test . To use a specific protocol choose it in the list box and press OK to confirm.

the first data will be displayed in a table format.

them, this in order to monitor the patient before starting the test. To start storing data press F2.

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Parameters to view

View graphs in real-time

1. Choose Graph from the View menu.

2. Follow the instructions described in data management section to edit the graphs.

While the test is running, it is possible to choose the parameters to view.

1. Select Parameters to view/Test execution… from the Options menu.

2. Select the parameters and confirm.

Manual protocol



Tip: pressing the Shift key while choosing the marker option will allow you to enter the label for that marker.

Automatic protocol

Set the BPM alarm

If you are using the Quark with a treadmill without serial interface, it is possible to enter manually from the PC the event, the phase and the marker.

Enter Load and Phase

1. During the test select Load from the Events menu.

2. Select the phase and/or type the value of the load and press OK to confirm.

Set the markers

Select Marker from the Events menu.

The software allows to automatically control the ergometer according to the protocol previously selected. Anyway it is allowed to change it even after the test is started.

Modify the load during the test

1. During the test choose Ergometric protocol from the Events menu.

2. Select the row corresponding to the desired load and press OK to confirm.

The software allows the user to set the alarm level for the heart rate, in order to monitor the patient response.

Enter the BPM

1. Choose BPM alarm from the Events menu.

2. Set the alarm by moving the scroll bar and press OK to confirm.

It also allows to enable or disable the acoustic alarm by the option "Acoustic alarm".

Chapter 12 - Exercise Testing - 97

Data management

As soon as the test has been completed, all data stored can be retrieved for a complete management.

Viewing data

Data can be viewed in the following formats:

Table form numeric values of the various parameters (columns) corresponding to

Graphic form graphical presentation on Y1, Y2, X charts.

Summary results of the test and statistical analysis of the blocks.

Predicted predicted values, maximum value measured.

View data in table form

1. Select Data… from the View menu.

2. Select the test to visualise in the list box and press OK



Note: Double-click in the window to open the edit test.

each step (rows).

Creating graphs

The software is provided with powerful functions for creating charts. You can add custom graphs to create exactly what you need.

View data in graph form

1. Choose Graph… from the View menu.

2. Select the tests to visualise from the list and press OK

3. Choose the parameters you require on the X, Y1 and eventually for Y2; select if necessary some of the following options by pressing the more button and press OK to confirm.

It is possible to access quickly 5 common graphs from the View/Graph… dialog box.

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

Note: Double-click in the graph window to open the edit test

Right-clicking, the graph can be exported in bmp file format.

Customise the graphs

1. With a graph on the screen, choose Customise graph from the View menu.

2. On the Customise graph dialog box, select options to obtain the wished graph.

Option Function

Grid on X, Y axes show the grid lines in correspondence with x or y axes that

make the graph easier for you to analyse data.

Autoscale maximum and minimum values of the graph will be measured

automatically.

Ignore 0 points with 0 value measured won't be shown.

Not interpolated make the graph scattered.

Marker highlight with a symbol all steps of the test in which the marker

button was pressed.

Squared makes the graph a square

Without recovery exclude from the graph all points of the recovery phase.

Mark points marks each point with a symbol

Min. Max. allows to set manually the axes values.

Step Set the axes' scale step.

Switch from graph to data and vice versa

When the active window is a graph (or a report in data form), it is possible to view very quickly the data (or the graph) corresponding to that test.

Choose Current test data (if the active window is a graph) or Current test graph… (if the active window is a data report) from the View menu.

Chapter 12 - Exercise Testing - 99

Viewing predicted values

For some parameter it is possible to compare the maximum value measured during the test with its predicted value and the LT value both in percentage and absolute.

View predicted values

Choose Predicted from the View menu.

Anaerobic (Lactate) Threshold detection

The software allows to detect the Lactate Threshold (Anaerobic Threshold) according to the "Modified V-slope method" reference. The LT can be detected both manually and automatically.



Note: Double-click in the window to open the corresponding dialog box.

View the Lactate Threshold

Choose Lactate Threshold from the View menu.

Detect the Lactate Threshold

1. Choose Calculate LT from the Test menu.

2. For calculating it automatically on the "Lactate Threshold" dialog box click on the Auto detect button.

3. For adjusting manually the point you want to detect, move the scroll bar on the dialog box by pressing the arrow buttons. Data and graph of the LT will be automatically redrawn.

4. Press Ok button to save your choices.

Customise graphs for the LT viewing

The software allows to customise two of the three graphs for the LT visualisation.

1. Choose Lactate Threshold from the Options menu.

2. Choose the parameters you want to be shown on the LT window and press OK to

100 - Quark PFT User Manual

confirm your choices.

Cosmed Quark PFT User Manual

Specifications and Main Features

Frequently Asked Questions

User Manual