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

Copyright © 1998 COSMED

Copyright © 2003 COSMED

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
Register the product via software ..................................	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
Create a new predicted parameter.................................	108
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 always be kept on hand.

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

•using the accessories described in the manual or given with the device. Actually non recommended accessories can affect safety unfavourable. Before using non recommended accessories it is necessary to get in touch with the manufacturer;

•ordinary equipment maintenance, inspections, disinfection and cleaning are performed in the way and with the frequency described;

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

•the environmental conditions and the electrical plants where the device operates are in compliance with the specifications of the manual and the present regulations concerning electrical plants. In particular grounding reliability and leakage current suppression can only be assured when the device three – wire receptacle is connected to a yellow - green return connected to earth ground. Attempting to defeat the proper connection of the ground wire is dangerous for users and equipment.

3.Before powering the system, check the power cables and the plugs. Damaged electrical parts must be replaced immediately by authorised personnel.

4.Large gas cylinders, which may be given by the manufacturer or purchased by the customer, should be secured with cylinder safety chains or safety stands.

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

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

ON

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 3rd month. For MVV test:

•hyperventilation syndrome

Contraindications for Bronchial provocation tests

The bronchial provocation tests must be executed according to the doctor’s discretion. There are not data that reveal specific contraindication for the bronchial provocation test through inhalation.

The modern standard processes have been revealing secure in several clinical studies. However it is recommendable to respect the following contraindications:

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 CH4 analysers.

•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

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.

Register the product via software

Together with the PC software, a registration software is supplied. With this software it is possible to fill in an electronic form with the customer information.

1.To run the software, double click on the icon Registration or select Registration… from ? menu.

2.Type the requested information and click Send… to send the form via e-mail to COSMED.

How to contact COSMED

For any information you may need, please contact the manufacturer directly at the following address:

COSMED S.r.l.

Via dei Piani di Monte Savello, 37 P.O. Box n. 3

00040 - Pavona di Albano Rome - ITALY

Voice: +39 (06) 931.5492

Fax: [phone]

email: [e-mail] Internet: http: //www.cosmed.it

Complain, feedback and suggestions

If you have any complain, feedback information or suggestion, please inform us at [e-mail].

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 cmH2O s/L @ 12 L/s
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% O2	0-100% O2
Accuracy:	±0.05% O2	±0.03% O2
Carbon Dioxide Sensor (CO2)
Type:	NDIR
Response time:	<120 ms
Range:	0-15%
Accuracy:	±0.03%
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	ml/min	Carbon Dioxide production
	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
30 - Quark PFT User Manual