quark_pft_user_manual_vii_edition.pdf
Page 1
Cosmed does not assume the liability for interpretation mistakes of this documentation or for casual or
consequential damages in connection with the provision, representation or use of this documentation.
No parts of this manual may be reproduced or transmitted in any form without the express permission of
COSMED Srl.
COSMED Software can be installed only in one device.
Excel is a registered trademark of Microsoft Corporation.
DBIII is a registered trademark of Bordland International Inc.
Lotus 123 is a registered trademark of Lotus Development Corporation .
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
Page 2
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
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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
Page 4
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
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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
Page 6
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
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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
Page 8
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
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Page 9
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
Page 10
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
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Getting started
Page 12
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;
3.
4.
5.
6.
12 - Quark PFT User Manual
• the environmental conditions and the electrical plants where the device operates
are in compliance with the specifications of the manual and the present regulations
concerning electrical plants. In particular grounding reliability and leakage current
suppression can only be assured when the device three – wire receptacle is
connected to a yellow - green return connected to earth ground. Attempting to
defeat the proper connection of the ground wire is dangerous for users and
equipment.
Before powering the system, check the power cables and the plugs. Damaged
electrical parts must be replaced immediately by authorised personnel.
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.
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.
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
Page 13
7.
8.
9.
10.
11.
12.
13.
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.
Cleaning residue, particulates, and other contaminates (including pieces of torn or
broken components) in the breathing circuit pose a safety risk to the patient during
testing procedures. Aspiration of contaminates can potentially be life-threatening.
You must follow all the cleaning procedures in System Maintenance, and you must
thoroughly inspect the components after cleaning and before each patient test.
This device is not suitable for use in presence of flammable anaesthetics. It is not
an AP nor an APG device (according to the EN 60 601-1 definitions).
Keep the device away from heat and flame source, flammable or inflammable
liquids or gases and explosive atmospheres.
In accordance with their intended use Quark PFT is not to be handled together with
other medical devices unless it is clearly declared by the manufacturer itself.
It is recommended to use a computer with electromagnetic compatibility CE
marking and with low radiation emission displays.
It is necessary to make the PC, connected to the Quark PFT, compliant with EN
60601-1 by means of an isolation transformer.
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
Page 14
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.
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Page 15
Environmental condition of use
COSMED units have been conceived for operating in medically utilised rooms without
potential explosion hazards.
The units should not be installed in vicinity of x-ray equipment, motors or transformers
with high installed power rating since electric or magnetic interferences may falsify the
result of measurements or make them impossible. Due to this the vicinity of power lines
is to be avoided as well.
Cosmed equipment are not AP not APG devices (according to EN 60601-1): they are
not suitable for use in presence of flammable anaesthetic mixtures with air, oxygen or
nitrogen protoxide.
If not otherwise stated in the shipping documents, Cosmed equipment have been
conceived for operating under normal environmental temperatures and conditions [IEC
601-1(1988)/EN 60 601-1 (1990)].
•
Temperature range 10°C (50°F) and 40°C (104°F).
•
Relative humidity range 20% to 80%
•
Atmospheric Pressure range 700 to 1060 mBar
•
Avoid to use it in presence of noxious fumes or dusty environment and near heat
sources.
•
Do not place near heat sources.
•
Cardiopulmonary 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
Page 16
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
Page 17
Keynotes
Here are the keynotes used to make the manual easier to read.
Typographic keynotes
These are the typographic keynotes used in the manual.
Style
Description
Bold
“Italic”
indicates a control or a key to be pressed.
indicates a messages shown by the firmware.
Graphic keynotes
These are the graphic keynotes used in the manual.
Illustration
Description
shows the button to click in the software to activate the related feature.
Chapter 1 - Getting started - 17
Page 18
Systems Overview
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
Forced Vital Capacity
PFT 1
PFT 2
PFT 3
•
•
•
PFT 4 PFTErgoPFT2ergoPFT4ergo
•
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
Exercise Testing
•
Indirect Calorimetry
Oxymetry
option
MIP-MEP
18 - Quark PFT User Manual
option
option
option
•
•
•
•
•
option
option
option
option
option
option
•
•
•
option
option
option
option
option
option
option
option
option
option
option
Ergometer Control
Integration with Quark C12/T12 ECG
•
•
Page 19
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
C02120-01-05
C02171-01-11
A 662 100 001
C01739-02-35
C00137-01-20
C00136-01-20
A 362 060 001
A 362 300 001
A 680 013 630
A 680 024 125
C00067-02-94
C01340-02-91
C01999-02-DC
1
1
1
2
1
50
50
1
1
2
2
1
1
1
Quark PFT 1 unit
Turbine Ø 28mm
Kit optoelectronic reader Quark PFT1
Nose clips
PC Software
Paediatric paper mouthpieces
Adult paper mouthpieces
Power cord Schuko L 2m
Serial cable RS 232 DB9 M/F
Time Lag Fuses 5x20 250V T630 mA
Time Lag Fuses 5x20 250V T 1,25A
Registration card
User manual Quark PFT
Conformity declaration
Quark PFT2 standard packaging
Code
Qty
Description
C00932-01-04
C02120-01-05
C02171-02-11
A 182 310 001
C01590-01-05
C00243-01-06
C02210-02-08
C00269-01-20
A 830 300 001
A 182 300 004
A 108 106 002
A 662 100 001
C00137-01-20
C00136-01-20
C01739-02-35
A 362 060 001
A 362 300 001
A 680 013 630
A 680 024 125
C00067-02-94
C01340-02-91
C01999-02-DC
1
1
1
5
1
1
1
20
1
10
2
2
50
50
1
1
1
2
2
1
1
1
Quark PFT 2 unit
Turbine Ø 28mm
Kit optoelectronic reader Quark PFT2/3/4
Antimoisture filter
Breathing valve PFT2 (1 way)
Calibration syringe 3 litres
Permapure L 2m
PTE soft mouthpieces
Air valve membrane
Antibacterial filter
Tank tubing 6x8 98 shore
Nose clips
Paediatric paper mouthpieces
Adult paper mouthpieces
PC software
Power cord Schuko L 2 mt
Serial cable RS 232 DB9 M/F
Time Lag Fuses 5x20 250V T630 mA
Time Lag Fuses 5x20 250V T1,25A
Registration card
User manual Quark PFT
Conformity declaration
Chapter 1 - Getting started - 19
Page 20
Quark PFT3 standard packaging
Code
Qty
Description
C00933-01-04
C02120-01-05
C02171-02-11
C01730-01-05
C00243-01-06
C02210-02-08
A 182 300 004
A 830 300 001
A 662 100 001
C00137-01-20
C00136-01-20
A 182 310 001
C00269-01-20
C01739-02-35
A 108 106 002
A 362 060 001
A 362 300 001
A 680 013 630
A 680 024 125
C00067-01-94
C01340-02-91
C01999-02-DC
1
1
1
1
1
2
10
1
2
50
50
5
20
1
1
1
1
2
2
1
1
1
Quark PFT 3 unit
Turbine Ø 28mm
Kit optoelectronic reader Quark PFT2/3/4
Breathing valve PFT3/4 (3 ways)
Calibration syringe 3 litres
Permapure L 2 m
Antibacterial filter
Air valve membrane
Nose clips
Paediatric paper mouthpieces
Adult paper mouthpieces
Antimoisture filter
PTE soft mouthpieces
PC software
Tank tubing 6x8 98 shore
Power cord Schuko L 2 mt
Serial cable RS 232 DB9 M/F
Time Lag Fuses 5x20 250V T630 mA
Time Lag Fuses 5x20 250V T630 mA
Registration card
User manual Quark PFT
Conformity declaration
Quark PFT4 standard packaging
Code
Qty
Description
C00934-01-04
C02120-01-05
C02171-02-11
C01730-01-05
C00243-01-06
C02210-02-08
A 182 300 004
A 662 100 001
C00137-01-20
C00136-01-20
A 182 310 001
C01739-02-35
A 362 060 001
A 362 300 001
A 108 106 002
A 830 300 001
A 680 013 630
A 680 024 125
C00067-02-94
C00269-01-20
C01340-02-91
C01999-02-DC
1
1
1
1
1
2
10
2
50
50
5
1
1
1
3
1
2
2
1
20
1
1
Quark PFT4 unit
Turbine Ø 28mm
Kit optoelectronic reader Quark PFT 2/3/4
Breathing valve PFT3/4 (3 ways)
Calibration syringe 3 litres
Permapure L 2 m
Antibacterial filter
Nose clips
Paediatric paper mouthpieces
Adult paper mouthpieces
Antimoisture filter
PC software
Power cord Schuko 2 mt
Serial cable RS 232 DB9 M/F
Tank Tubing 6x8 shore
Air valve membrane
Time Lag Fuses 5x20 250V T630 mA
Time Lag Fuses 5x20 250V T1,25A
Registration card
PTE soft mouthpieces
User manual Quark PFT
Conformity declaration
20 - Quark PFT User Manual
Page 21
Quark PFT Ergo standard packaging
Code
C00935-01-04
C02120-01-05
C02170-01-11
C00243-01-06
C02210-02-08
C01399-02-12
A 800 900 001
C02125-01-10
C02135-01-10
C02145-01-10
A 182 310 001
C01739-02-35
C01740-02-35
A 362 060 001
A 362 300 001
A 108 106 002
C00861-01-06
A 661 200 001
A 661 200 002
A 680 013 630
A 680 024 125
C00067-02-94
C01340-02-91
C01999-02-DC
Qty
1
1
1
1
2
1
2
1
1
1
5
1
1
1
1
1
1
1
1
2
2
1
1
1
Description
Quark PFT Ergo unit
Turbine Ø 28mm
Kit optoelectronic reader Ergo
Calibration syringe 3 litres
Permapure L 2 m
Cable in HR TTL
Head cap for the adult masks
Mask mouth/nose breath adult S
Mask mouth/nose breath adult M
Mask mouth/nose breath adult L
Anti moisture filter
PC software Spiro
PC software Ergo
Power cord Schuko L 2m
Serial cable RS 232 DB9 M/F
Tank tubing 6x8 98 Shore
HR probe
Polar belt
HR transmitter watertight
Time Lag Fuses 5x20 250V T630 mA
Time Lag Fuses 5x20 250V T1,25A
Registration card
User manual Quark PFT
Conformity declaration
Quark PFT2 ergo Standard packaging
Code
Qty
Description
C00936-01-04
C02120-01-05
C02171-02-11
C01590-01-05
A 800 900 001
C00243-01-06
A 108 106 002
C02210-02-08
C01399-02-12
C02125-01-10
C02135-01-10
C02145-01-10
C00861-01-06
A 661 200 001
A 661 200 002
C00269-01-20
C00137-01-20
C00136-01-20
A 182 300 005
A 182 310 001
A 362 060 001
1
1
1
1
2
1
2
2
1
1
1
1
1
1
1
20
50
50
10
5
1
Quark PFT2 ergo unit
Turbine Ø 28mm
Kit optoelectronic reader Quark PFT 2/3/4
Breathing valve PFT2
Head cap for the adult masks
Calibration Syringe 3L
Tank tubing 6x8 98 shore
Permapure L2m
Cable in HR TTL
Mask mouth/nose breath adult S
Mask mouth/nose breath adult M
Mask mouth/nose breath adult L
HR probe
HR elastic belt
HR polar transmitter
PTE soft mouthpiece
Paediatric paper mouthpieces
Adult paper mouthpieces
Antibacterial filter
Anti moisture filter
Power cord Schuko 2m
Chapter 1 - Getting started - 21
Page 22
A 362 300 001
A 662 100 001
A 680 013 630
A 680 024 125
A 830 300 001
C01739-02-35
C01740-02-35
C01999-01-DC
C00067-02-94
C01340-02-91
1
2
2
2
1
1
1
1
1
1
RS232 cable DB9 M/F
Nose clips
Time lag fuses 5x20 250V T630mA
Time lag fuses 5x20 250V T1,25A
Air valve membrane
PC software Spiro
PC software Ergo
Conformity declaration
Registration card
Quark PFT User Manual
Quark PFT4 ergo Standard packaging
Code
Qty
Description
C00937-01-04
C02120-01-05
C02171-02-11
A 800 900 001
C00243-01-06
A 108 106 002
C02210-02-08
C01399-02-12
C02125-01-10
C02135-01-10
C02145-01-10
C00861-01-06
A 661 200 001
A 661 200 002
C00269-01-20
C00137-01-20
C00136-01-20
A 182 300 005
A 182 310 001
A 362 060 001
A 362 300 001
A 662 100 001
A 680 013 630
A 680 024 125
A 830 300 001
C01739-02-35
C01740-02-35
C01999-01-DC
C00067-02-94
C01340-02-91
1
1
1
2
1
3
1
1
1
1
1
1
1
1
20
50
50
10
5
1
1
2
2
2
1
1
1
1
1
1
Quark PFT4 ergo unit
Turbine Ø 28mm
Kit optoelectronic reader Quark PFT 2/3/4
Head cap for the adult masks
Calibration Syringe 3L
Tank tubing 6x8 98 shore
Permapure L2m
Cable in HR TTL
Mask mouth/nose breath adult S
Mask mouth/nose breath adult M
Mask mouth/nose breath adult L
HR probe
HR elastic belt
HR polar transmitter
PTE soft mouthpiece
Paediatric paper mouthpieces
Adult paper mouthpieces
Antibacterial filter
Anti moisture filter
Power cord Schuko 2m
RS232 cable DB9 M/F
Nose clips
Time lag fuses 5x20 250V T630mA
Time lag fuses 5x20 250V T1,25A
Air valve membrane
PC software Spiro
PC software Ergo
Conformity declaration
Registration card
Quark PFT User Manual
22 - Quark PFT User Manual
Page 23
Warranty registration
Before using the system, please take a moment to fill in the registration form and the
warranty and return them to COSMED, by doing this you are eligible to the customers
assistance service.
For further information, please refer to the enclosed registration and warranty form. If
the form is not enclosed in the packaging, please contact directly COSMED.
Register the product via software
Together with the PC software, a registration software is supplied. With this software it
is possible to fill in an electronic form with the customer information.
1. To run the software, double click on the icon Registration or select Registration…
from ? menu.
2. Type the requested information and click Send… to send the form via e-mail to
COSMED.
How to contact COSMED
For any information you may need, please contact the manufacturer directly at the
following address:
COSMED S.r.l.
Via dei Piani di Monte Savello, 37
P.O. Box n. 3
00040 - Pavona di Albano
Rome - ITALY
Voice: +39 (06) 931.5492
Fax: +39 (06) 931.4580
email: customersupport@cosmed.it
Internet: http: //www.cosmed.it
Complain, feedback and suggestions
If you have any complain, feedback information or suggestion, please inform us at
complain@cosmed.it.
Chapter 1 - Getting started - 23
Page 24
Options/Accessories
The following options are available to enhance or to complete the Quark PFT system:
Code
A 860 000 004
A 860 000 005
A 860 000 006
A 860 000 007
C01500-01-04
C01700-01-04
A 870 150 001
A 870 150 002
C09001-02-99
C00689-01-30
C01278-01-30
C01277-01-30
A 800 900 004
24 - Quark PFT User Manual
Quantity
1
1
1
1
1
1
1
1
1
1
1
1
1
Description
Calibration cylinder (5% CO2, 16% O2, balance N2)
DLCO cylinder (0.3% CO, 0.3& CH4, 21% O2, balance N2)
DLCO st. state cylinder (0.3% CO, 0.3% CH4, 21% O2, balance N2)
O2 cylinder
Trolley for Quark PFT
Trolley with arm for Quark PFT
Pressure regulator for cal./DLCO cylinder
Pressure regulator for O2 cylinder
Spirovis system for MIP and MEP measurement
Mask mouth/nose breath ID28 adult XL
Mask mouth/nose breath ID28 paediatric L
Mask mouth/nose breath ID28 paediatric S
Paediatric Headcap
Page 25
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