Cosmed does not assume the liability for interpretation mistakes of

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, XI Edition
03/2005
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
EMC ................................................................................................. 16
Safety and conformity..................................................................... 19
Safety..............................................................................19
EMC ...............................................................................19
Quality Assurance ..........................................................19
Medical Device Directive (CE mark).............................19
Keynotes ......................................................................................... 20
Typographic keynotes...............................................................20
Graphic keynotes ......................................................................20
Systems Overview........................................................................... 21
Tests/Products table..................................................................21
Before starting................................................................................ 22
Checking the packing contents .................................................22
Quark PFT1 standard packaging ....................................22
Quark PFT2 standard packaging ....................................22
Quark PFT3 standard packaging ....................................23
Quark PFT4 standard packaging ....................................23
Quark PFT Ergo standard packaging .............................24
Quark PFT2 ergo Standard packaging ...........................24
Quark PFT4 ergo Standard packaging ...........................25
Warranty registration..................................................................... 26
Register the product via software...................................26
How to contact COSMED..............................................26
Complain, feedback and suggestions .............................26
Options/Accessories ....................................................................... 27
PC configuration required .............................................................. 28
Technical features........................................................................... 29
Flowmeter.......................................................................29
Oxygen Sensor (O2) ........................................................29
2 - Quark PFT User Manual
Carbon Dioxide Sensor (CO2) ........................................29
Carbon Monoxide sensor (CO) ......................................29
Methane sensor (CH4) ....................................................29
Humidity absorber..........................................................29
Power Supply .................................................................29
Environmental Sensors...................................................29
Dimension and Weight...................................................29
Aux inputs ......................................................................29
Measurements
31
Pulmonary function tests and measured parameters ....................32
Spirometry Tests.......................................................................32
FVC - Forced Vital Capacity .........................................32
VC/IVC - Slow Vital Capacity and Ventilatory pattern.32
MVV - Maximum Voluntary Ventilation ......................33
Bronchoprovocation Response.......................................33
Multi-breath Nitrogen wash-out.....................................33
Closing Volume test.......................................................33
CO diffusion Test...........................................................33
Respiratory Drive - P0.1 Test.........................................34
MIP/MEP .......................................................................34
Cardio pulmonary Exercise Testing (CPET)............................34
Breath by Breath exercise testing...................................34
Indirect Calorimetry .......................................................35
Lactate Threshold (V-Slope)..........................................35
O2 Kinetics.....................................................................35
Installation
37
Unpacking the system.....................................................................38
Setting up the system......................................................................39
Installing the Calibration Gas Cylinders ..................................39
Gas pressure adjustment procedure ..........................................39
Connecting cables and tubing ........................................................40
Cables and Tubing’s installation sequence...............................41
Assemble the breathing valve...................................................41
Optoelectronic reader .....................................................41
Assemble the turbine ......................................................................42
Assemble the mask and the flowmeter...........................42
Using the "Ultimate Seal".........................................................42
Apply the seal to the mask .............................................43
To remove seal on mask.................................................43
Connecting PC..........................................................................43
Software installation .......................................................................44
Installing the software ..............................................................44
Run the software.......................................................................44
PC port configuration ...............................................................44
Chapter 17 - Appendix - 3
Software main features .................................................................. 45
Display......................................................................................45
Tool bar.....................................................................................45
Show/hide the toolbar.....................................................45
Dialog windows ........................................................................45
Use of the keyboard........................................................45
Use of the mouse ............................................................45
Scroll bars .................................................................................45
On-line help ..............................................................................45
Software version .......................................................................45
Calibration
47
Calibrating Sensors ........................................................................ 48
Running the Calibration program .............................................48
Log file .....................................................................................48
Setting reference values............................................................48
To set the reference values .............................................48
Calibrating analysers ................................................................49
ERGO Calibration ..........................................................49
FRC Calibration .............................................................49
DLCO Calibration ..........................................................49
Print the calibration report ........................................................50
Edit the calibration factors........................................................50
O2 delay check ..........................................................................50
Turbine calibration ......................................................................... 51
The calibration syringe...................................................51
Assembling the flowmeter for calibration.....................51
Calibrating the turbine ..............................................................52
Checking the system signals .......................................................... 53
The control panel ......................................................................53
Using the control panel...................................................53
Database Management
55
Spirometry patient's database ....................................................... 56
Patient Card ....................................................................56
Visit Card .......................................................................56
Test Card ........................................................................57
Import/export a Tests card ........................................................57
Diagnosis Database...................................................................57
Exercise testing patient's database ................................................ 58
Enter a new patient ...................................................................58
Find a patient ............................................................................58
Edit patient data ........................................................................58
Delete a patient .........................................................................58
Archive maintenance...................................................................... 59
Reorganise the archive..............................................................59
Delete the archive .....................................................................59
4 - Quark PFT User Manual
Delete a test ..............................................................................59
Backup and restore ...................................................................59
Backup............................................................................59
Restore............................................................................59
Spirometry Settings.........................................................................60
Graphs ............................................................................60
Serial port .......................................................................60
Units of measurements...................................................60
Using extra fields ...........................................................60
Customise the fields .......................................................60
Spirometry
61
Setting spirometry options..............................................................62
Spirometry ................................................................................62
Automatic Interpretation ................................................62
Quality control ...............................................................62
Parameters manager..................................................................63
Predicted values manager .........................................................63
Predicteds set..................................................................63
Set the current predicted.................................................64
Formula definition..........................................................64
Page set-up................................................................................65
Spirometry tests ..............................................................................66
Forced Vital Capacity (pre)..............................................................67
Recommendations ....................................................................67
Perform a FVC (pre) test ..........................................................67
Test encouragement..................................................................67
Perform the FVC test with the encouragement ..............68
Slow Vital Capacity..........................................................................69
Perform a SVC test...................................................................69
Maximum Voluntary Ventilation.....................................................70
Perform a MVV test .................................................................70
Bronchial Provocation Test .............................................................71
Bronchodilator test ...................................................................71
Methacholine and Histamine Bronchial provocation Tests......71
Perform the test.........................................................................72
Bronchial Provocation protocols Database...............................72
Enter a new Bronchial provocation protocol in the
archive ............................................................................72
Viewing results................................................................................73
Tests of the current patient.............................................73
Delete a test ....................................................................73
Printing results................................................................................74
Printing Reports........................................................................74
Printing the active window.......................................................75
To print the active window.............................................75
Printing a series of reports ........................................................75
Chapter 17 - Appendix - 5
Electronic reports (*.pdf)..........................................................75
Export data................................................................................75
Export a test....................................................................75
Lung Volumes
77
Lung volumes tests (N2 washout) ................................................... 78
Recommendations ..........................................................78
Setting N2 wash-out options.....................................................78
Perform the test.........................................................................79
Closing Volume Test (CV)................................................................ 80
Recommendations ..........................................................80
Perform the test.........................................................................80
P0.1 Respiratory drive
83
P0,1 (Respiratory drive).................................................................. 84
Aim of the test ..........................................................................84
Setting respiratory drive options...............................................84
Recommendations ..........................................................84
Perform the test.........................................................................84
Lung diffusing capacity
87
CO Diffusing Capacity (DLCO) Test ................................................. 88
Setting DLCO options ..............................................................88
Recommendations ..........................................................89
DLCO with breath-hold (standard technique) ..........................89
DLCO with apnoea (standard method).....................................89
DLCO without apnoea (“intrabreath” method) ........................91
Multiple breath DLCO test (“Steady-State” method)...............91
MIP/MEP (option)
93
MIP/MEP test................................................................................... 94
How to perform the test ............................................................94
Pulse oximetry (option)
95
The oximetry test ............................................................................ 96
How to perform the test ............................................................96
Airway resistance measurement (option)
97
The airway resistance measurement test....................................... 98
Preparing the ROCC module and connecting to the unit.............98
Performing the test....................................................................98
Exercise testing
101
Recommendations for the exercise testing .................................. 102
The evaluation of the cardiorespiratory function....................102
Precautions..............................................................................102
6 - Quark PFT User Manual
Laboratory ....................................................................102
Ending the test..............................................................102
Preparing the patient...............................................................102
Before testing ...............................................................102
Patient assent................................................................103
Ending the test..............................................................103
Start Testing ..................................................................................104
Start a test.....................................................................104
Abort the test without saving data................................104
End the test saving data................................................104
View data in real-time ............................................................104
View graphs in real-time ..............................................105
Parameters to view .................................................................105
Manual protocol......................................................................105
Enter Load and Phase...................................................105
Set the markers.............................................................105
Automatic protocol.................................................................105
Modify the load during the test ....................................105
Set the BPM alarm..................................................................105
Enter the BPM..............................................................105
Data management........................................................................106
Viewing data...........................................................................106
View data in table form................................................106
Creating graphs.......................................................................106
View data in graph form...............................................106
Customise the graphs ...................................................107
Switch from graph to data and vice versa ....................107
Viewing predicted values .......................................................108
View predicted values ..................................................108
Anaerobic (Lactate) Threshold detection ...............................108
View the Lactate Threshold .........................................108
Detect the Lactate Threshold........................................108
Customise graphs for the LT viewing ..........................108
Fittings....................................................................................109
Fit a graph with a linear regression ..............................109
Fit a graph with a Mono-exponential regression..........109
Calculate the "Mean Value" .........................................110
Oxygen Kinetic.......................................................................110
Run the O2 Kinetic function ........................................110
Information about the Test .....................................................111
View the Information ...................................................111
Modify the information ................................................111
Summary.................................................................................111
View the summary .......................................................111
Print the data...........................................................................111
Print the current window..............................................112
Chapter 17 - Appendix - 7
Print the report..............................................................112
View the report .......................................................................112
Data Editing.................................................................................. 113
Editing values and input numerical values...................113
Data filtering.................................................................113
Using the User fields ....................................................114
Deleting steps ...............................................................114
Advanced Editing.........................................................114
Restore the original test................................................115
Overwrite the original test............................................115
Customise the desktop ............................................................115
Customise the display colours......................................115
Smart edit................................................................................115
Apply the graphical noise suppression .........................115
Apply the threshold noise suppression .........................115
Customise the parameters .......................................................116
Create a new parameter ................................................116
Create a new predicted parameter .................................116
Exporting data.........................................................................117
Export a test..................................................................117
DDE with Excel............................................................117
Creating Test Protocols ................................................................. 118
Create a new protocol...................................................118
Software configuration ................................................................. 119
Data viewing...........................................................................119
Select the parameters to view .......................................119
Select the parameters to view during the test ...............119
Sort the parameters.......................................................119
Steady State ............................................................................119
Customise the Steady State detection criteria ..............119
Printout reports ............................................................................ 120
Set up the printout ........................................................120
Select parameters to be printed.....................................120
Customise the printout header......................................120
Electronic reports (*.pdf) .............................................121
Print the current window ........................................................121
Print the customised report .....................................................121
Events management during exercise testing ............................... 122
Flow Volume loops.................................................................122
Flow Volume loop during the test................................122
O2, CO2 vs Time....................................................................122
O2, CO2 vs Time during the test..................................122
O2 Saturation (optional) .........................................................122
O2 Saturation during the test........................................123
Spirogram ...............................................................................123
Spirogram during the test .............................................123
8 - Quark PFT User Manual
View the events after the test..................................................123
Raw data .................................................................................123
Save Raw data ..............................................................123
Resting Metabolic Rate Test
125
Metabolism ...................................................................................126
Total Metabolic Rate ..............................................................126
Resting Metabolic Rate (RMR)..............................................126
Importance to measure RMR..................................................126
Measurement of the rest metabolic rate with indirect
calorimetry..............................................................................126
How to perform a RMR test ...................................................126
Recommendations.........................................................................127
Resting metabolic rate test using the face mask .....................127
Resting metabolic rate test using the canopy option ..............127
Performing a test using the face mask.........................................128
Calibrations.............................................................................128
How to prepare a patient.........................................................128
Start the test ............................................................................128
Viewing the test......................................................................129
How to modify the average interval .......................................130
Print ........................................................................................130
Performing a test using the canopy option ..................................132
Calibrations.............................................................................132
How to prepare the canopy and the patient ............................132
Replacement of the power plug....................................132
Connecting the Canopy ................................................132
How to prepare the patient ...........................................133
Performing the test .................................................................133
Viewing the test......................................................................134
How to modify the average interval .......................................134
Print ........................................................................................134
Sub-maximal Exercise Testing
135
Introduction...................................................................................136
Pre-test screening....................................................................136
Sub-maximal exercise testing.......................................................137
Considerations with sub-maximal exercise testing.................137
Staffing ...................................................................................138
Test termination......................................................................138
Considerations for accuracy ..........................................................139
Performing the test .......................................................................140
An example of testing protocol ..............................................140
System maintenance
141
System maintenance .....................................................................142
Cleaning and disinfection .......................................................142
Chapter 17 - Appendix - 9
Preparing the disinfecting solution...............................142
Cleaning the turbine flowmeter ....................................143
Precautions during the cleaning of the turbine .............143
Suggested disinfection solutions ..................................143
Cleaning the Breathing valve..................................................143
Masks cleaning and disinfection.............................................144
Disassembling the different parts of the mask .............144
Cleaning the mask ........................................................144
Disinfecting the mask...................................................144
Permapure maintenance..........................................................145
Inspections ..............................................................................145
Replace the fuses ....................................................................145
Select the proper power supply voltage..................................146
Appendix
147
Service - Warranty........................................................................ 148
Warranty and limitation of liability ........................................148
Return goods policy for warranty or non warranty repair ......148
Repair Service Policy .............................................................149
Privacy Information ...................................................................... 150
Personal data treatment and purposes.....................................150
How your personal data are treated ........................................150
The consent is optional, but… ................................................150
Holder of the treatment...........................................................150
Customer rights.......................................................................150
Heart Rate – TTL input .................................................................. 151
Converting factors configuration.................................................. 152
Calculations references ................................................................ 153
VO2 and VCO2 ........................................................................153
Anaerobic threshold (modified V-Slope) ...............................153
References ....................................................................153
O2 kinetics...............................................................................153
ATS 94 recommendations ............................................................. 154
ATS recommendations ...........................................................154
Predicted values ........................................................................... 155
Automatic diagnosis (algorithm) ............................................156
Quality Control Messages.......................................................156
References .................................................................................... 158
Spirometry....................................................................158
Lung Volumes ..............................................................158
Single-Breath with Apnea ............................................158
Single-Breath without Apnea .......................................158
Resistances ...................................................................158
Gas Exchange References ............................................158
Indirect calorimetry ......................................................158
Sub-maximal testing.....................................................159
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;
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
7.
8.
9.
10.
11.
12.
13.
14.
15.
16.
17.
18.
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.
Use disposable anti-bacterial filters or disinfect each part in contact with the patient
before each test.
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.
The Quark PFT needs special precautions regarding EMC and needs to be installed
and put into service according to the EMC information provided in the section
EMC.
Portable and mobile RF communications equipment can affect the Quark PFT.
Use only the cable and accessories supplied with the equipment. The use of
accessories and/or cables other than those supplied may result in increased
emissions or decreased immunity of the equipment.
The Quark PFT should not be used adjacent to or stacked with other equipment. If
adjacent or stacked use is necessary, the Quark PFT should be observed to verify
normal operation in the configuration in which it will be used.
Graphical symbols used in accordance to present specifications are described here
below:
Equipment type B (EN60601-1)
Equipment type BF (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. FEV1 < 1.51 in men and FEV1
in women < 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
EMC
Guidance and manufacturer’s declaration - electromagnetic emissions
The Quark PFT is intended for use in the electromagnetic environment specified below. The
customer or the user of the Quark PFT should assure that it is used in such an environment.
Emissions test
Compliance
Electromagnetic environment - guidance
RF emissions
Group 1
The Quark PFT uses RF energy only for its internal
function. Therefore, its RF emissions are very low and
CISPR 11
are not likely to cause any interference in nearby
electronic equipment.
RF emissions
Class B
The Quark PFT is suitable for use in all establishments,
including domestic establishments and those directly
CISPR 11
connected to the public low-voltage power supply
Harmonic Emission
Class A
network that supplies buildings used for domestic
IEC 61000-3-2
purposes.
Voltage Fluctuations /
Complies
Flicker Emission
IEC 61000-3-3
Guidance and manufacturer’s declaration - electromagnetic immunity
The Quark PFT is intended for use in the electromagnetic environment specified below. The
customer or the user of the Quark PFT should assure that it is used in such an environment.
Immunity test
Test level
Compliance level
Electromagnetic
environment - guidance
Electrostatic
±6 kV contact
±6 kV contact
Floors should be wood,
discharge (ESD)
concrete or ceramic tile. If
±8 kV air
±8 kV air
floors are covered with
IEC 61000-4-2
synthetic material, the relative
humidity should be at least
30%.
Electrical fast
±2 kV for power
±2 kV for power
Mains power quality should
transient/burst
supply lines
supply lines
be that of a typical
commercial
or
hospital
IEC 61000-4-4
±1 kV for
±1 kV for
environment.
input/output lines
input/output lines
Surge
±1 kV differential ±1 kV differential Mains power quality should
mode
mode
be that of a typical
IEC 61000-4-5
commercial
or
hospital
±2 kV common
±2 kV common
environment.
mode
mode
Voltage dips, short
interruptions
and
voltage variations on
power supply input
lines
IEC 61000-4-11
Power frequency
(50/60 Hz) magnetic
field
IEC 61000-4-8
<5% UT
(>95% dip in UT)
for 0.5 cycles
40% UT
(60% dip in UT) for
5 cycles
70% UT
(30% dip in UT) for
25 cycles
<5% UT
(>95% dip in UT)
for 5 sec
3 A/m
<5% UT
(>95% dip in UT)
for 0.5 cycles
40% UT
(60% dip in UT) for
5 cycles
70% UT
(30% dip in UT) for
25 cycles
<5% UT
(>95% dip in UT)
for 5 sec
3 A/m
Mains power quality should
be that of a typical
commercial
or
hospital
environment. If the user of the
Quark PFT requires continued
operation during power mains
interruptions,
it
is
recommended that the Quark
PFT be powered from an
uninterruptible power supply
or a battery.
Power frequency magnetic
fields should be at levels
characteristic of a typical
location
in
a
typical
commercial
or
hospital
environment.
Note: UT is the a.c. mains voltage prior to application of the test level.
16 - Quark PFT User Manual
Guidance and manufacturer’s declaration - electromagnetic immunity
The Quark PFT is intended for use in the electromagnetic environment specified below. The
customer or the user of the Quark PFT should assure that it is used in such an environment.
Immunity test
Test level
Compliance
Electromagnetic environment level
guidance
Portable and mobile RF communications
equipment should be used no closer to
any part of the Quark PFT, including
cables, than the recommended separation
distance calculated from the equation
applicable to the frequency of the
transmitter
Recommended separation distance
Conducted RF
IEC 61000-4-6
3 Veff
150 kHz to
80 MHz
3V
Radiated RF
IEC 61000-4-3
3 V/m
80 MHz to
2.5 GHz
3 V/m
d=1.17
P
d=1.17
P
80 MHz to 800 MHz
d=2.33 P 800 MHz to 2.5 GHz
where P is the maximum output power
rating of the transmitter in watts (W)
according to the transmitter manufacturer
and d is the recommended separation
distance in metres (m).
Field
strengths
from
fixed
RF
transmitters, as determined by an
electromagnetic site surveya, should be
less than the compliance level in each
frequency rangeb.
Interference may occur in the vicinity of
equipment marked with the following
symbol:
Notes:
(1) At 80 MHz, the higher frequency range applies.
(2) These guidelines may not apply in all situations. Electromagnetic propagation is affected by
absorption and reflection from structures, objects and people.
a Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless)
telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV
broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic
environment due to fixed RF transmitters, an electromagnetic site survey should be
considered. If the measured field strength in the location in which the Quark PFT is used
exceeds the applicable RF compliance level above, the Quark PFT should be observed to
verify normal operation. If abnormal performance is observed, additional measures may be
necessary, such as reorienting or relocating the Quark PFT.
b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
Chapter 1 - Getting started - 17
Recommended separation distances between portable and mobile RF communications
equipment and the Quark PFT
The Quark PFT is intended for use in an environment in which radiated RF disturbances are
controlled. The customer or the user of the Quark PFT can help prevent electromagnetic
interference by maintaining a minimum distance between portable and mobile RF
communications equipment (transmitters) and the Quark PFT as recommended below, according
to the maximum output power of the communications equipment..
Rated maximum
Separation distance according to frequency of transmitter
output power of
(m)
transmitter (W)
150 kHz to 80 MHz
80 MHz to 800 MHz
800 MHz to 2.5 GHz
d=1.17
P
d=1.17
P
d=2.33
P
0.01
0.12
0.12
0.23
0.1
0.37
0.37
0.74
1
1.17
1.17
2.33
10
3.70
3.70
7.38
100
11.70
11.70
23.33
For transmitters rated at a maximum output power not listed above, the recommended separation
distance d in metres (m) can be determined using the equation applicable to the frequency of the
transmitter, where P is the maximum output power rating of the transmitter in watts (W)
according to the transmitter manufacturer.
Notes:
(1) At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
(2) These guidelines may not apply in all situations. Electromagnetic propagation is affected by
absorption and reflection from structures, objects and people.
18 - Quark PFT User Manual
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 EN ISO 9001:2000 (Registration n° 387-A Cermet)
Medical Device Directive (CE mark)
MDD 93/42/EEC (Notified Body 0476).
Class IIa
Chapter 1 - Getting started - 19
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.
20 - Quark PFT User Manual
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
Rocc
Canopy
option
option
option
•
•
•
•
•
option
option
option
option
option
option
•
•
•
option
option
option
option
option
option
Ergometer Control
Integration with Quark C12/T12 ECG
•
•
option
option
option
option
option
option
option
option
option
option
option
option
option
option
option
Chapter 1 - Getting started - 21
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
C01788-01-36
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
C00191-02-11
A 662 100 001
C00137-01-20
C00136-01-20
C01788-01-36
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
1
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 4m
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
22 - Quark PFT User Manual
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
C01788-01-36
C00191-01-11
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 2m
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
C01788-01-36
A 362 060 001
A 362 300 001
C00191-03-11
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
1
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 6m
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
Chapter 1 - Getting started - 23
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
C01788-01-36
C01790-01-36
A 362 060 001
A 362 300 001
C00191-01-11
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 2m
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
C00191-02-11
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
1
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 4m
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
24 - Quark PFT User Manual
A 362 300 001
A 662 100 001
A 680 013 630
A 680 024 125
A 830 300 001
C01788-01-36
C01790-01-36
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
C00191-03-11
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
C01788-01-36
C01790-01-36
C01999-01-DC
C00067-02-94
C01340-02-91
1
1
1
2
1
1
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 6m
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
Chapter 1 - Getting started - 25
Warranty registration
Before using the system, please take a moment to fill in the registration form and the
warranty and return them to COSMED, by doing this you are eligible to the customers
assistance service.
For further information, please refer to the enclosed registration and warranty form. If
the form is not enclosed in the packaging, please contact directly COSMED.
Register the product via software
Together with the PC software, a registration software is supplied. With this software it
is possible to fill in an electronic form with the customer information.
1. To run the software, double click on the icon Registration or select Registration…
from ? menu.
2. Type the requested information and click Send… to send the form via e-mail to
COSMED.
How to contact COSMED
For any information you may need, please contact the manufacturer directly at the
following address:
COSMED S.r.l.
Via dei Piani di Monte Savello, 37
P.O. Box n. 3
00040 - Pavona di Albano
Rome - ITALY
Voice: +39 (06) 931.5492
Fax: +39 (06) 931.4580
email: [email protected]
Internet: http: //www.cosmed.it
Complain, feedback and suggestions
If you have any complain, feedback information or suggestion, please inform us at
[email protected].
26 - Quark PFT User Manual
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
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
Chapter 1 - Getting started - 27
PC configuration required
•
Pentium II 350 MHz.
•
Windows 98, XP.
•
64 Mb RAM .
•
CD 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
28 - Quark PFT User Manual
Technical features
Flowmeter
Type:
Flow Range:
Accuracy:
Resistance:
Ventilation Range:
Bidirectional digital turbine Ø 28 mm
0,03-20 L/sec
± 2%
<0.7 cmH2O s/L @ 12 L/s
0-300 litres x min
Oxygen Sensor (O2)
Type
Response time:
Range:
Accuracy:
Galvanic Fuel Cell
<120 ms
0-100% O2
±0.05% O2
Paramagnetic (option)
<120 ms
0-100% O2
±0.03% O2
Carbon Dioxide Sensor (CO2)
Type:
Response time:
Range:
Accuracy:
NDIR
<120 ms
0-15%
±0.03%
Carbon Monoxide sensor (CO)
Type:
Response time:
Range:
Accuracy:
NDIR
<200 ms
0-0.3%
±0,003%
Methane sensor (CH4)
Type:
Response time:
Range:
Accuracy:
NDIR
<200 ms
0-0.3%
±0,003%
Humidity absorber
Capillary of Nafion (Permapure ®)
Power Supply
Voltage:
Power consumption
100V-240V ±10%; 50/60Hz
100W
Environmental Sensors
Temperature:
Barometer:
Humidity:
0-50°C
400-800 mmHg
0-100%
Dimension and Weight
Dimensions:
Weight:
17x30x45 cm
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.
Chapter 1 - Getting started - 29
30 - Quark PFT User Manual
Measurements
Pulmonary function tests and measured parameters
Spirometry Tests
FVC - Forced Vital Capacity
Symbol
UM
Parameter
FVC
FEV1
FEV1/FVC%
PEF
FEV0.5
FEV6
FEV1/FEV6
FEV6/FVC%
Best FVC
Best FEV1
Best PEF
Vmax25%
Vmax50%
Vmax75%
FEF25-75%
FET100%
FEV2
FEV3
FEV2/FVC%
FEV3/FVC%
FEV1/VC%
FEF50-75%
FEF75-85%
FEF0.2-1.2%
FiVC
FiF25-75%
FiV1
PIF
VEXT
PEFT
l
l
%
l/sec
l
l
%
%
l
l
l/sec
l/sec
l/sec
l/sec
l/sec
sec
l
l
%
%
%
l/sec
l/sec
l/sec
L
l/sec
l/sec
l/sec
ml
msec
Forced Expiratory Vital Capacity
Forced Expiratory Volume in 1 sec
FEV1 as a percentage of FVC
Peak Expiratory Flow
Forced Expiratory Volume in 0.5 sec
Forced Expiratory Volume in 6 sec
FEV1 as a percentage of FEV6
FEV6 as a percentage of FVC
Best Forced Expiratory Vital Capacity
Best Forced Expiratory Volume in 1 sec
Best Peak Expiratory Flow
Expiratory Flow when 75% of the FVC remains to be exhaled
Expiratory Flow when 50% of the FVC remains to be exhaled
Expiratory Flow when 25% of the FVC remains to be exhaled
Mid-exp flow between 25-75%FVC
Forced expiratory time
Forced Expiratory Volume in 2 sec
Forced Expiratory Volume in 3 sec
FEV2 as a percentage of FVC
FEV3 as a percentage of FVC
Tiffenau index
Mid-exp flow between 50-75%FVC
Mid-exp flow between 75-85%FVC
Mid-exp flow between 0.2 l - 1.2 l
Inspiratory Forced Vital Capacity
Forced mid-inspiratory flow
Forced Inspiratory Volume in 1 sec
Peak Inspiratory Flow
Extrapolated Volume (back extrapolation)
Time to PEF (10% - 90%)
VC/IVC - Slow Vital Capacity and Ventilatory pattern
Symbol
UM
Parameter
EVC
IVC
ERV
IRV
IC
VE
Vt
Rf
Ti
Te
l
l
l
l
l
l/min
l
1/min
sec
sec
Expiratory Vital Capacity
Inspiratory Vital Capacity
Expiratory Reserve Volume
Inspiratory Reserve Volume
Inspiratory Capacity
Expiratory Minute Ventilation
Tidal Volume
Respiratory Frequency
Duration of Inspiration
Duration of Expiration
32 - Quark PFT User Manual
Ttot
Ti/Ttot
Vt/ti
sec
—l/sec
Duration of Total breathing cycle
Ti/Ttot ratio
Vt/ti ratio
MVV - Maximum Voluntary Ventilation
Symbol
UM
Parameter
MVV
MVt
MRf
MVVt
l/min
l
1/min
sec
Maximum Voluntary Ventilation
Tidal Volume (during MVV)
Maximum Respiratory frequency
MVV duration time
Bronchoprovocation Response
Symbol
UM
Parameter
FallFEV1
FallVmax50%
P10
P15
P20
%
%
———-
Fall in FEV1 from baseline or post diluent
Fall in Vmax50% from baseline or post diluent
Provocative dose causing FEV1 to fall 10% from baseline
Provocative dose causing FEV1 to fall 15% from baseline
Provocative dose causing FEV1 to fall 20% from baseline
Multi-breath Nitrogen wash-out
Symbol
UM
Parameter
FRC
RV
TLC
Vtot
FetN2
Wash-out time
VDA
LCI
AMDN
FRC/TLC
CEV
RV/TLC
l
Functional Residual Capacity
l
Residual Volume
l
Total Lung Capacity
l
Total volume during the test
%
Final Nitrogen Concentration
m
Duration of wash-out
L
Anatomic dead space
mm:ss Lung Clearance Index
mm:ss Mean Dilution Number
%
FRC/TLC ratio
l
Cumulated Volume of inspired Oxygen
%
RV/TLC ratio (Motley index)
Closing Volume test
Symbol
UM
Parameter
CV
VC(c.v.)
V_I
V_II
V_III
m, q, R^2
CV/VC%
VDf
l
l
l
l
l
l
%
ml
Closing Volume
Expired volume during wash-out
Related Volume at the end of phase I
Related Volume at the end of phase II
Related Volume at the end of phase III
Parameters of the linear fitting on the alveolar plateau
CV as a percentage of VC
Dead volume (Fowler)
CO diffusion Test
Symbol
UM
Parameter
DLco
DLco 3eq
ml/min/mmHg
ml/min/mmHg
CO Diffusion Capacity
DLco computed with the Three Equations method.
Chapter 2 - Measurements - 33
DLco corr
DLco/VA
Dm
Vc
FaCO
FACH4
ta
FiCO
FiCH4
wash-out vol.
Vsample vol.
IVC (DLCO)
TLC (DLCO)
ml/min/mmHg
ml/min/mmHg
ml/min/mmHg
ml
%
%
sec
%
%
%
%
l
l
CO Diffusion Capacity corrected for Hb, COHb, PB.
Krogh factor
Membrane Diffusion capacity
Capillary Volume
Alveolar concentration of CO
Alveolar concentration of CH4
Apnoea time
Inspiratory concentration of CO
Expiratory concentration of CH4
Rejection Volume
Sampling volume
IVC calculated during test DLCO
Total Lung Capacity
Respiratory Drive - P0.1 Test
Symbol
UM
Parameter
P0.1
FiCO2
RF
Vt
cmH2O
%
1/min
l
Respiratory drive
Inspiratory CO2 (PFT2 and PFT4 only)
Respiratory Frequency
Tidal Volume
MIP/MEP
Symbol
UM
Parameter
MIP
MEP
cm H2O
cm H2O
Maximum inspiratory pressure
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
VCO2
Vt
FetO2
FetCO2
R
VE
HR
Qt
AT
VE
SV
RF
FeO2, FeCO2
VE/VO2
VE/VCO2
VO2/HR
VO2/Kg
ml/min
ml/min
l
%
%
--l/min
1/min
l
--l/min
l/min
1/min
%
----ml/beat
ml/min/Kg
Oxygen Uptake
Carbon Dioxide production
Tidal Volume
End Tidal O2
End Tidal CO2
Respiratory Quotient
Ventilation
Heart Rate
Cardiac output
Anaerobic Threshold
Ventilation
Stroke volume
Respiratory Frequency
Averaged expiratory concentration of O2 e CO
ventilatory equivalent for O2
ventilatory equivalent for CO2
Oxygen pulse
VO2 per Kg
34 - Quark PFT User Manual
Ti, Te, Ti/Ttot
Vd/Vt
PaCO2
P(a-et)CO2
sec
--mmHg
mmHg
time breaths
Vd/Vt ratio
arterial PCO2 (estimated)
Delta PaCO2 – PetCO2
Indirect Calorimetry
Symbol
UM
Parameter
EE
EE/BSA
EE/Kg
FAT
CHO
PRO
FAT%
CHO%
PRO%
npRQ
Kcal/day
Kcal/day/m2
Kcal/day/Kg
Kcal/day
Kcal/day
Kcal/day
%
%
%
—-
Energy Expenditure
Energy Expenditure/Body surface area
Energy Expenditure pro Kg
Fats
Carbohydrate
Protein
% Fat
% Carbohydrate
% Protein
Respiratory quotient not protein
Lactate Threshold (V-Slope)
Symbol
UM
Description
VO2 @ LT
l/m
Lactate (Anaerobic) Threshold
R @ LT
Time @ LT
VCO2
-hh:mm:ss
ml/min
Respiratory Quotient @ LT
Time @ LT
CO2 output @ LT
STPD
VE
HR
l/min
bpm
Ventilation @ LT
Heart Rate @ LT
STPD
BTPS
O2 Kinetics
Parameter
UM
Calculation
O2 deficit
l/m
VO2@work*tau
O2 debt
l/m
VO2'@work*tau
Chapter 2 - Measurements - 35
36 - Quark PFT User Manual
Installation
Unpacking the system
On receipt of your system, you should immediately inspect your package for shipping
damages, in case damage is suspected please contact the reseller immediately. Your
system has to be installed by COSMED or by an authorised reseller.
Excessive amount of dust and miscellaneous clutter around the instrument can
eventually cause malfunctions due to overheating of components, we strongly suggest
to keep the unit in a clean environment and well ventilated as possible.
Quark PFT and accessories can have place on the trolley as shown in the following
illustration.
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
38 - Quark PFT User Manual
Quark unit
Printer
Calibration cylinder
Keyboard
Mouse pad
Table arm
Breathing valve
PC
Trolley
Bag
Setting up the system
Before starting operating with the system make sure to meet the environmental and
operational conditions reported in Chapter 1.
Installing the Calibration Gas Cylinders
In order to calibrate the sensors you need to have available calibration cylinders with
the following gas concentrations:
Cylinder
Recommended Gas mixture
Test
Calibration O2 16%, CO2 5%, N2 Bal
Washout, CV, P0.1, Ergo, MIP-MEP
DLCO
CO 0.3%, CH4 0.3%, O2 21%, N2 Bal DLCO
Oxygen
O2 100 %
Washout, CV
Gas pressure adjustment procedure
The gas regulator has an adjustable second stage that must be adjusted only when used
for the first time. This is necessary to protect the internal demand valve from the high
pressure surge that can be generated when the cylinder is opened.
1. Make sure that the regulator is turned off before opening the cylinder valve.
2. Open the cylinder valve by turning the valve counter-clockwise.
3. Adjust the regulator pressure by turning the adjustment knob clockwise in order to
Notice: The cylinders must be
reach a value between 5 and 6 atmospheres (bar).
provided with a calibration
certificate, indicating the gas
composition.
Notice: The gas cylinder must be replaced when the primary pressure gauge falls below
10 bar.
Chapter 3 - Installation - 39
Connecting cables and tubing
The assembling procedure will be shown in the following illustrations.
A
D
E
F
G
H
Heart Rate Probe connector
Flowmeter connector
Calibration plug
Power switch
Sampling tube connector
Breathing valve connector
I
L
DLCO mix gas connector
Cal gas (16% O2, 5% CO2) connector
M
O
P
Q
R
O2 gas connector
RS232 Serial Port for PC connection
Ground snap connector
Power cable connector
Switch 110V / 220V
40 - Quark PFT User Manual
Cables and Tubing’s installation sequence
•
Connect the power cable of the Quark PFT to the trolley
•
Connect the power cable of the PC and the printer to the trolley
•
Connect the RS232 cable from the Quark PFT (PC RS232) to the PC (COM1 or
COM2). If the PC does not have a RS232 port, please use the USB-RS232 adapter
(A 388 410 001), available as an accessory.
•
Cut the tube as needed. Tubes connecting cylinders to Quark should be as short as
possible.
•
Connect the DLCO cylinder to the Quark PFT (DLCO) and adjust its pressure
between 5 and 6 bar.
•
Connect the O2 cylinder to the Quark PFT (O2) and adjust its pressure between 5
and 6 bar.
•
Connect the O2-CO2 calibration cylinder to the Quark PFT (CAL) and adjust its
pressure between 5 and 6 bar.
•
Connect the Flowmeter to the front panel of the Quark
Assemble the breathing valve
1. Pneumatic cable
2. Demand valve
3. Body valve
4. Air valve membrane
5. Air valve membrane protection
6. Optoelectronic reader
7. Mouthpiece
Optoelectronic reader
1. Optoelectronic reader
2. Turbine
3. Mouthpiece adapter
4. Flowmeter cable
5. Sampling line
Chapter 3 - Installation - 41
Assemble the turbine
Assemble the mask and the flowmeter
1.
2.
Insert the turbine in the optoelectronic reader, in the way indicated by the arrow in
the turbine.
Insert the turbine plug on the front panel.
Notice: It is advisable to
lubricate periodically the Orings inside the
optoelectronic reader with
sylicone grease for its good
maintenance.
3.
Connect the external anti moisture filter to the sampling plug and joint the
Permapure sampling line to the filter. It's strongly suggest to use the filter always
and we recommend to replace it every 3 months.
1. Headcap
2. Mask
3. Inspiratory valve
4. Turbine
5. Optoelectronic reader
6. Sampling adapter
7. Sampling plug
Using the "Ultimate Seal"
The "ultimate seal" is a moulded of Elasto-Gel, a glycerine based hydrogel. This
product is a unique polymer gel that forms an intimate seal between the face and the
mask. It has to be used for mask applications on hard to seal faces and where leaks are
not tolerated.
•
Will not irritate the skin
•
Contains no adhesives.
•
Has no odour
•
Will not dry out
•
Single patient use
42 - Quark PFT User Manual
Apply the seal to the mask
Apply seal to clean, residue-free mask only and follow the instructions below:
1. Remove the plastic tray from the bag. Peel off clear film and retain for later use.
2. While holding tray align the nose area of mask to nose area of Ultimate Seal™ gel.
Press together and roll mask down over the surface of the gel seal attaching it to the
mask and releasing it from the tray.
3. If needed, adjust the position of the seal, aligning it with the outer perimeter of the
mask sealing surface.
4. The mask is now ready to be placed on the subject's face.
To remove seal on mask
Notice: Avoid the exposure
to the sun. Do not put the
seal into the water.
•
The Ultimate Seal™ have been conceived for a single patient use only, it can not be
cleaned or sterilised.
•
If mask requires cleaning for a new patient application then pull off and dispose of
the Ultimate Seal™.
•
To keep the seal clean between use, keep it attached to the mask and place the clear
film against the Ultimate Seal™ gel on the mask. When the seal becomes
discoloured or opaque (approximately two weeks) dispose of the current seal and
replace it with a new one.
Connecting PC
Before operating the system make sure the unit is connected to the PC as described in
the following illustration:
Chapter 3 - Installation - 43
Software installation
The software is made of two programs: one for the spirometry and the other one for the
ergometry (only for PFTergo, PFT2ergo and PFT4 ergo). The two programs share the
same archive and use the same program for the system calibration, even if they are used
for performing completely different tests.
Installing the software
Notice: The software is
copy-protected. Install the
software from the original
disk.
1.
2.
3.
4.
5.
6.
Select Run... from Windows Start menu.
Insert the disk in the proper drive.
In the Command line, type <name of the drive>:\install.
Click on OK (or press ENTER key).
The program will load up a dialog box and ask for a directory where to be installed.
When the installation is over, the program will advise you with a message
indicating that the installation has been successfully completed, click on End.
Note: the directory for the Ergo software must be the same of the Quark PFT (spiro).
Run the software
1.
2.
In the Windows Program Manager, open the Program Group in which the software
was installed.
Click the Quark PFT icon.
PC port configuration
The first time the software is used, it is necessary to configure the communication port
with the PC (USB, COM1, COM2,…).
For further details, see the chapter Database management.
44 - Quark PFT User Manual
Software main features
Display
The program may contain several windows. The active window is highlighted with a
different colour of the caption. Some functions of the program are "active window"
sensitive (Print, right key of the mouse).
Tool bar
Many of the functions that may be selected from the menu can be activated more
rapidly by clicking with the mouse on the corresponding icon in the tool bar.
Positioning the mouse cursor on one of the buttons of the toolbar (if the option Hints is
enabled), the description of the corresponding function is shown in a label.
Show/hide the toolbar
Select Toolbar from Options menu in order to show or hide the toolbar.
Dialog windows
The typical operating environment of Microsoft Windows is the Dialog box. This
window is provided with a series of fields in which input the information.
Use of the keyboard
•
To move the cursor among fields, press the Tab key until you reach the desired
field.
•
Press the Enter key to confirm the information input on the dialog box or press the
Esc key to cancel changes.
Use of the mouse
•
To move the cursor among fields, move the mouse on the desired field and leftclick.
•
Click on the OK button with the Left button of the mouse to confirm the
information input on the dialog box or click on Cancel button to cancel changes.
Scroll bars
Some windows are provided with scroll bars that help to see data exceeding the window
space available.
•
To move the scroll bar row by row click the scroll arrows at the end of the scroll
bars
•
To move the scroll bar page by page click on the grey area at both sides of the
scroll fields
On-line help
COSMED Quark Help is a complete on-line reference tool that you can use at any time.
Help is especially useful when you need information quickly or when the Quark user
manual is not available. Help contains a description of each command and dialog box,
and explains many procedures for accomplishing common tasks.
To get the Help on line, press the F1 key.
Software version
To know the software version and the serial number of the software, select About
Quark PFT… from Help menu.
Chapter 3 - Installation - 45
46 - Quark PFT User Manual
Calibration
Calibrating Sensors
The software allows to automatically calibrate zero, gain and delay of gas sensors. Even
if the program doesn't force you to carry out the calibration we strongly recommend to
execute it before each test.
Running the Calibration program
Start the program and choose Calibration from the Test Menu. The software runs the
Calibration software and the main menu changes accordingly.
Log file
The program creates and updates as default the calibration log file, containing the
conditions and the results of all the calibrations performed by the user.
To access the file select File/Report File... from the calibration program.
Setting reference values
Before starting calibrating make sure that the system has been configured correctly by
setting the right values of gas concentration of: room air (i.e. 20.95% O2 and 0.03%
CO2), of gas mixture contained in the cylinders and the volume of the calibration
syringe (i.e. 3 litres).
To set the reference values
This operation must be performed only the first time. The next times, the system keeps
stored the reference values entered in this step.
1. Select Reference Values from the Calibration menu.
2. Type the correct values for the O2 and CO2 room air concentration (i.e. 2093 for
20.93%), and do the same for the gas concentration of the calibration cylinder.
3.
4.
48 - Quark PFT User Manual
Type the volume of the calibration syringe (i.e. 3000 for a 3 litres calibration
syringe).
Press OK button to confirm changes.
Calibrating analysers
Note: After turning on the
unit, wait 30 minutes warm
up time before starting the
calibration procedure.
ERGO Calibration
This calibration must be repeated at least daily. A new calibration before any
ergospirometry, P0.1 or MIP-MEP test is strongly recommended.
1. Remove the sampling line from the flowmeter.
2. Ensure that the O2-CO2 cylinder is properly connected to the rear panel of the
Quark PFT and check that the pressure of the gas is in the range 5-6 bar.
3. Check if the reference values for the calibration gas specified in File/Reference
values… correspond to the certified composition of the mixture.
4. Connect the sampling line to the CAL port placed on the front panel of the Quark
PFT.
5. Select Calibration/Gas…/ERGO… and wait until the procedure is completed.
The software performs automatically the calibration procedure. After 90 seconds the
graph will be displayed. In this way, the user can check the calibration procedure both
graphically and numerically.
At the end of the procedure, the software displays the new calibration factors vs. the old
ones.
FRC Calibration
This calibration must be repeated at least daily. A new calibration before any FRC or
CV test is strongly recommended.
1. Remove the sampling line from the flowmeter.
2. Ensure that the O2 cylinder is properly connected to the rear panel of the Quark PFT
and check that the pressure of the gas is in the range 5-6 bar.
3. Ensure that the O2-CO2 cylinder is properly connected to the rear panel of the
Quark PFT and check that the pressure of the gas is in the range 5-6 bar.
4. Check if the reference values for the calibration gas specified in File/Reference
values… correspond to the certified composition of the mixture.
5. Connect the sampling line to the CAL port placed on the front panel of the Quark
PFT.
6. Select Calibration/Gas…/FRC… and wait until the procedure is completed.
DLCO Calibration
This calibration must be repeated at least daily. A new calibration before any DLCO test
is strongly recommended.
1. Remove the sampling line from the flowmeter.
Chapter 4 - Calibration - 49
2.
3.
4.
5.
Ensure that the DLCO cylinder is properly connected to the rear panel of the Quark
PFT and check that the pressure of the gas is in the range 5-6 bar.
Check if the reference values for the calibration gas specified in File/Reference
values… correspond to the certified composition of the mixture.
Connect the sampling line to the CAL port placed on the front panel of the Quark
PFT.
Select Calibration/Gas…/DLCO… and wait until the procedure is completed.
Print the calibration report
In the Calibration program choose Print from the File menu.
Edit the calibration factors
The last sensors calibration factors can be either edited or viewed. To do this choose
Gas Results… from the File menu.
To view or edit the last Turbine calibration factor choose Turbine results… from the
File menu.
Note: To restore factory setting press Default button in the dialog box. Once you press
the default button you must run a new calibration before testing.
O2 delay check
Selecting Calibration/Gas/O2 delay, check if this value is below 250ms. If it is above
250ms, please contact the Technical Support.
An high value of the O2 delay can be due to:
•
Chemical sensor exhausted.
•
Old or obstructed Permapure tube.
•
Dust or dirt in the sampling line.
50 - Quark PFT User Manual
Turbine calibration
The system uses a turbine flowmeter. It opposes a very low resistance to flow (<0,7
cmH2O/l/s to 12 l/s). The air passing through the helical conveyors, takes a spiral
motion which causes the rotation of the turbine rotor.
The rolling blade interrupts the infrared light beamed by the three diodes of the
optoelectronic reader. Every interruption represents 1/6 turn of the rotor, this allows to
measure the number of turn in the time. There is a constant ratio between air passing
through the turbine and number of turns. This allows an accurate measure of flows and
volume. The turbine flowmeter doesn't need daily calibrations as it is not affected by
pressure, humidity and temperature.
To work properly, the turbine only requires the rotor to rotate freely without any friction
that might be caused by dust that can be easily avoided with an ordinary cleaning
procedure (see Maintenance).
However in order to ensure accuracy it's recommended to run periodically the
calibration procedure. Calibration has to be carried out with a calibration syringe of 3
litres volume, the calibration procedure is totally managed by software.
A measurement system should be calibrated daily in order to ensure maximum accuracy
and reliable test results. If a correct maintenance is provided it’s possible to check the
calibration of the turbine flowmeter even at relatively long intervals (i.e. 1 month). The
calibration procedure assures valid and verifiable results within a ±3% accuracy.
The calibration syringe
The 3 litres calibrated syringe is included in all the Quark PFT line with the exclusion
of the PFT 1 model.
3 litres calibration syringe: P/N C00600-01-11.
Assembling the flowmeter for calibration
1.
2.
Connect the Opto-reader to the calibration syringe through the adapter. Do not use
the breathing valve.
Connect the flowmeter to the syringe with the rubber cylinder supplied in the
standard packaging.
1. Syringe
2. Silicone tube
3. Adaptor for calibration syringe.
Note: If a bacterial filter is used for the tests, do use it also during the turbine
calibration.
Chapter 4 - Calibration - 51
Calibrating the turbine
Note: if you are using a slow
PC, we recommend to set
an higher refresh time.
After having run the calibration program:
1. Select Reference Values from the File menu. If your syringe has a different value
from the default one (3 litres), please enter the correct value.
2. Select Calibration/Turbine….
3. When the Calibration Turbine dialog box appears with the syringe piston initially
pushed all the way in, move the piston in and out for 5 inspiratory strokes and 5
expiratory strokes in order to get the first values appearing on the display. Then
move the syringe piston for other 10 strokes (IN and EX).
4.
5.
52 - Quark PFT User Manual
At each of the 10 steps the software displays the results of the manoeuvre and the
percentage error in the reading.
At the end of this operation, the software displays the new calibration factors. Press
OK to store the new value.
Checking the system signals
The control panel
The Control Panel, which can be activated from the Calibration/Control panel…
menu item, is a useful tool to check the main hardware functions of Quark PFT.
By using the controls on Control Panel you are able to do the following:
1. Reading the signals acquired by the system both as voltages and processed data;
2. Activating/Disactivating the valves, the sampling pump and other installed
components (for example, oxymeter).
Using the control panel
Calibration
valve
Sampling
flow rate
Apnoea valve
Breathing
valve air valve
Sampling
pump
mV / real values
display
Air valve for
DLCO
On/off cylinders
O2 sensor
range
On/Off infrared
sources
Signal refresh
time
Deselect all
channels
Analog
input
Oxymeter
HW zero trimmer
adjystment
Select all
channels
Chapter 4 - Calibration - 53
54 - Quark PFT User Manual
Database
Management
Spirometry patient's database
The Patients database consists of a Patient Card, a Visit Card and a Test Card in which
are listed all tests performed by the patient.
Select Archive Navigator from the File menu or press the button by side.
Patient Card
It collects all the information of a patient (first name, last name, date of birth) which
remain the same for each visit. For each patient there is only one Patient Card, which is
created the first time the Patient performs a test.
To move within the database use the following buttons:
Move to the first patient in the archive
Move to the previous patient in the archive
Note: after having deleted a
record (patient, visit or test),
it is recommended to
reorganize the archive in
order to free disk space.
Move to the next patient in the archive
Move to the last patient in the archive
Find a patient in the archive
Enter a new patient in the archive
Delete current patient from the archive
Edit the current patient card
Visit Card
It collects all information relative to the visit (diagnosis, visit description...) and to the
patient information subject to change between one visit and another (height, weight,
smoke). Each patient can be related to several Visit Cards provided they have been
created in different days. Before carrying out any spirometric test it is necessary to
create a new Visit Card or to open the today’s Visit Card.
To move within the database use the following buttons:
Move to the first visit in the archive
Move to the previous visit in the archive
Move to the next visit in the archive
Move to the last visit in the archive
Find a visit in the archive
56 - Quark PFT User Manual
Enter a new visit card in the archive
Delete current visit card from the archive
Edit the current visit card
Test Card
It contains all the information about the test.
To move within the database use the following buttons:
Delete current test from the archive.
Edit the current test
Import/export a Tests card
This function allows to import /export a test card with the respective visit and patient
card.
1. Select the patient.
2. Choose the test and press the key by side. All data will be imported/exported in the
XPO file format (Cosmed proprietary).
Diagnosis Database
The program allows to manage a diagnosis database, whose records are composed by a
diagnosis ID code and a string of text.
The report of the visits can be done either by typing the desired text in the field
“Diagnosis” of the Visit Card or, more quickly, retrieving from the diagnosis database
the desired one.
If you want to insert, modify or delete a diagnosis from the database select Database
Diagnosis... from the File menu.
Chapter 5 - Database Management - 57
Exercise testing patient's database
The exercise testing software uses a different interface for presenting patient
information. The patient database allows to:
•
Enter a new patient
•
Find patient data
•
Edit patient data
• Delete patient data.
Select Patients from the File menu.
Enter a new patient
1.
2.
Press New to show the Patient dialog box.
Enter data of a new patient and press OK button to confirm.
Find a patient
Enter a search string into the Find field and press Find to view the data concerning a
subject already in the database. You can search for “Last name”, “ID code” or
“Progressive”.
Or:
Press List to view the list of patients in the database. Press Next or Previous to view
the data corresponding to the next or to the last patient. Press OK to confirm.
The Next and Previous buttons allow to move to the next or the previous patient in the
database.
Edit patient data
1.
2.
3.
Select the patient.
Press Modify… in order to edit the patient’s data.
Edit the desired values and press OK to confirm.
1.
2.
Select the patient to be deleted.
Press Delete.
Delete a patient
58 - Quark PFT User Manual
Archive maintenance
The software allows to manage files selecting Archive from the File menu.
It is advisable to perform the archive reorganisation every month, in order to free space
on the hard disk and/or to correct possible errors present within the database.
It is possible also that your have no more hard disk space. So, you have to delete all the
data. In this case, it is useful to perform the initialising.
Reorganise the archive
1.
2.
Select Reorganize archive from the File menu.
Wait for the end of the operation before performing any other function.
1.
2.
Select Initialize Archive from the File menu.
Wait for the end of the operation before performing any other function.
Delete the archive
Delete a test
To delete an ergometry test, select Test/Delete test.
To delete a spirometry test, press the proper button in the Test Card.
Backup and restore
It is strongly recommended to backup files, a warning message will be displayed
monthly. This function allows the user to restore the data if the PC or the HD will not
work anymore.
Backup
1.
2.
3.
Select Backup archive from the File menu.
Selecting the destination path with the Browse key or press New to create a new
directory. Press OK to confirm.
In the dialog box it will appear an estimate of the number of floppy disks you need
in order to back up the archives. Press OK.
Restore
1.
2.
Select Restore archive from the File menu.
On the Restore dialog box specify the drive source and press OK, a dialog box
will appear indicating all data of the backup processed.
Chapter 5 - Database Management - 59
Spirometry Settings
Quark PFT software allows to configure some options selecting Configure from the
Option menu.
Graphs
All the graphs visualised and/or printed can be customised in colours and appearance.
1. Select the desired colours of the curves (5 curves max can be overlapped on the
same graph).
2. Enable or disable the Grid option.
3. Enable or disable the Show Info Test option.
Serial port
You must select the serial port RS 232 that will be used to connect the Quark PFT with
the PC.
To select the serial port, click on the proper COM button (the selected port must be
different from the mouse one).
Units of measurements
It is possible to configure the units of measurements, weight and height, for printing and
viewing.
To select the units of measurement click on cm/Kg or in/lb according to the desired
format.
Using extra fields
The Patient’s database is organised in 3 different cards (Patient card, Visit Card and
Test card.) where it is possible to store the information about patients and visits .
Besides the standard information, it is possible to customise some fields (user free
fields), entering and labelling measurements coming from other devices.
The customisable free fields are:
•
3 fields in the Patient Card (Patient’s information)
•
3 fields in the Visit Card (information about the visits)
•
3 fields (2 numeric) in the Test card information about Test)
Customise the fields
In the group User free fields type the desired text in the 9 fields available.
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Spirometry
Setting spirometry options
The software allows to configure some options selecting Configure from the Option
menu.
Spirometry
Automatic Interpretation
Quark PFT has the function of interpreting each test performed by a patient visualising
an automatic diagnosis. The algorithm has been calculated basing on “Lung Function
Testing: selection of reference values and interpretative strategies, A.R.R.D. 144/
1991:1202-1218”.
The automatic diagnosis is calculated at the end of the FVC Test if:
•
the automatic diagnosis option is enabled.
•
the patient’s anthropometric data allow the calculation of the LLN (Lower Limit of
Normal range).
• at least one FVC test has been performed.
To enable/disable the automatic diagnosis:
1. Click on Enable Automatic Interpretation checkbox to enable or disable the
calculation and the visualisation of the automatic interpretation.
2. Select the LLN (Lower Limit of Normal Range) criteria among the ATS
(LLN=Pred-0.674*SD), ERS (LLN=Pred-1.647*SD) or 80%Pred (LLN=Pred*0.8)
specifications.
Quality control
Quark PFT allows a quality test control. The calculation has been carried out referring
to “Spirometry in the Lung Health Study: Methods and Quality Control, A.R.R.D. 1991;
143:1215-1223”. The messages concerning the quality control are shown at the end of
the test.
To enable/disable the quality control, click on Enable Quality Control checkbox.
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Parameters manager
The program allows to calculate a huge number of parameters; it is advisable, in order
to simplify the analysis of the results, to view, to print and to sort the desired parameters
only. Select the menu item Options/Parameters...
View
Move the parameters to view into the Selected parameters list.
Print
Move the parameters to print into the Selected parameters list.
Sort
Drag the parameter up or down with the mouse.
Customise
Add, modify and delete custom parameters.
If it is necessary to restore the default parameters press the button in the left corner of
the window to initialise the parameters database.
Predicted values manager
The program contains a preset of predicted equations, but the user is allowed to
customise its own predicted sets. Select Predicteds... from Options menu.
The window is divided into two forms: Predicteds set and Formula definition.
Predicteds set
This form allows the user to manage the set of predicteds. The following information
define a set:
Chapter 6 - Spirometry - 63
Name:
identifies the set and cannot be duplicated;
Description: free field;
Age:
the adult predicteds start since this age.
To enter a new set of predicteds click on the New button. The field Name must be filled
and must be unique. To stop without saving click on the Cancel button. To save the set,
click on the Save button.
To delete a set of predicteds click on the Delete button. If a set is deleted, also the
associated formulae are deleted.
It is possible to generate a new set of predicteds with the same attributes and the same
formulae of the selected one. To do this click on the Copy... button and specify a new
Name.
To import a set of predicteds click on the Import... button and select a file of Predicteds
files type.
To export a set of predicteds click on the Export... button.
In the list Set current predicteds choose the current predicteds for printing and
viewing.
Set the current predicted
Quark PFT allows to calculate the predicted values according to the following
configurable sets:
Adults
Paediatrics
ERS 93
Zapletal
Knudson83
Knudson83
ITS white
ITS white
ITS black
ITS black
LAM
LAM
MC Barcelona
MC Barcelona
Nhanes III
Nhanes III
Select the desired choice in the group Predicted.
Formula definition
This form allows the user to manage the formulae associated to a set of predicteds.
Select the set of predicteds from the list Predicteds set.
To insert a new parameter click on the New... button.
The parameter formulae can be:
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•
calculated according to the predicteds in the list Use the predicteds formulae;
• customised by the user with the option ...or the customised formulae.
The Delete button deletes the selected parameter.
The Copy button stores the selected parameter in memory.
The Paste button inserts a new parameter from the one copied. If the name is not
unique, the user is asked whether to specify a new name or to replace the existing
parameter.
Page set-up
Select Page Setup... from the File menu.
Header
All the printouts carried out by the program are preceded by 3
rows of customisable header (usually they contain the name
and the address of the Hospital using the spirometer).
Data
Patient and visit information are printed below the header.
These data are reported on 3 columns and 5 rows. the user may
configure the disposition, change and eventually cancel the
fields, as he prefers.
Margins
Configures the print margins from the borders of the paper.
The unit of measure is decided in Units of measurements.
Footer
Configures information at the bottom of the page.
Printed file name
Defines the automatic name to be asssigned to the pdf file, if
the report will be printed in this format.
In the example it has been set to create a filename composed by
<date of the test> followed by <last name> and <first name>.
Chapter 6 - Spirometry - 65
Spirometry tests
Note: Read carefully the
contraindications in Chapter 1.
Once completed the phases of the introduction of the patient’s data and the visit data, it
is possible to carry out the spirometric tests.
Quark PFT allows to perform the following tests:
Key
Test
FVC pre
FVC post
SVC
MVV
FRC
CV
DLCO
P0,1
Forced Vital Capacity
Forced Vital Capacity after bronchial stimulation
Slow Vital Capacity
Maximum Voluntary Ventilation
Nitrogen Wash-out
Closing Volume
CO Diffusing capacity
Respiratory Drive
Note: The FVC, SVC and MVV tests must be performed with the flowmeter
disconnected from the breathing valve.
Before performing any test make sure that:
1. Quark PFT is properly connected to your PC and the selected serial port (COM1,
COM2) corresponds to the one effectively use.
2. The name shown on the status bar corresponds to the patient who is to carrying out
the tests.
3. The today’s visit card exists.
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Forced Vital Capacity (pre)
FVC is a reference test to verify obstructive (airflow limitations) and restrictive
disorders (lung volume limitations). To achieve good test results it is fundamental a
good manoeuvre (quality control messages, real time plots …)
The main parameters measured during FVC tests are:
FVC
Forced Vital Capacity
FEV1
Forced Expiratory Volume in 1 second
FEV1/FVC%
FEV1 as a percentage of FVC
PEF
Peak Expiratory Flow
FEF25-75%
Forced mid-Expiratory Flow
The two representative plots are the Flow/Volume and Volume/Time loops.
By comparing FVC, FEV1 and FEV1/FVC% values the software allows an automatic
interpretation concerning the levels of obstructive and/or restrictive disorders.
Recommendations
•
The flowmeter has to be disconnected from the breathing valve
•
The patient should wear the nose clips
•
The turbine has been recently calibrated (ATS recommends a daily calibration)
•
The paper mouthpiece or the antibacterial filter is properly connected to the
flowmeter through the corresponding adapter
For hygienic reasons, we strongly recommend the use of a bacterial filter.
If a kid must perform the test it is recommended to enable the encouragement function
which shows exactly the manoeuvre of the FVC test.
Perform a FVC (pre) test
1.
2.
3.
4.
5.
Select Forced Vital Capacity pre from the Test menu and wait for the green led is
prompted on the right side of the screen.
Explain the manoeuvre to the patient and press the F2 key.
Wait some seconds and perform the test.
After having performed the test, press F3 or wait for the automatic end (5 seconds
without flow), so that the software displays the F/V and V/t graphs, the main
parameters, and the predicteds values.
In order to visualise the F/V and V/t graph and the main parameters press the
following buttons:
view Flow Volume graph
view Volume Time graph
6.
7.
8.
9.
view data of the test
Press Alt+F3 to stop the acquisition discarding the results.
Repeat the test until it is correctly performed (ATS recommends 3 times).
Press Exit to visualise the test list carried out during current session together with
the results of the main parameters.
Select the test that you want to save (the Best Test according to the ATS criteria is
highlighted as default) and press OK.
Test encouragement
During FVC manoeuvre you might experience some lack of collaboration with kids or
with other patients. In this case you may find a good help in using the encouragement
software tool.
Chapter 6 - Spirometry - 67
Perform the FVC test with the encouragement
1.
2.
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Select Encouragement from View menu.
Perform the test as explained in the previous paragraph.
Slow Vital Capacity
Important test for assessing COPD (chronic obstructive pulmonary disease) patients
affected by this disease might present a the Slow Vital Capacity could be higher than
the Forced one (FVC).
The main parameters measured during SVC tests are:
EVC
Expiratory Slow Vital Capacity
IVC
Inspiratory Slow Vital Capacity
ERV
Expiratory Reserve Volume
IRV
Inspiratory Reserve Volume
If the inspiratory/expiratory maximal manoeuvre is preceded by a some breaths at tidal
volume the software allows to measure the Respiratory Pattern, represented by the
following parameters:
VE
Ventilation per minute
Vt
Tidal volume
Rf
Respiratory frequency
Ttot
Breath time
Ti/Ttot
Inspiratory time/Ttot
Vt/Ti
Vt/Ti
Perform a SVC test
1.
2.
3.
4.
Select Slow Vital Capacity from the Test menu and wait for the green led is
prompted on the right side of the screen.
Press F2 and instruct the Patient to breath normally until the message “carry out…”
is prompted; then ask to perform a Slow Vital Capacity (deep inhalation, maximal
slow expiration and deep inhalation again).
Press F3 or wait for automatic interruption (5 seconds without flow) in order to
visualise the V/t graph together with the main parameters compared to the predicted
values
To visualise the V/t graph and the main parameters press the follow buttons:
view Volume Time graph
view data of the test
Press Alt+F3 to stop the acquisition discarding the results.
Repeat the test until it is correctly performed (ATS recommends 3 times).
Press Exit to visualise the test list carried out during current session together with
the results of the main parameters.
8. Select the test that you want to save (the Best Test according to the ATS criteria is
highlighted by default) and press OK.
The reference for the ERV calculation is displayed on the V/T graph.
5.
6.
7.
Chapter 6 - Spirometry - 69
Maximum Voluntary Ventilation
Test for assessing the maximum ventilatory capacity. In the past, it was commonly
performed during routine PF tests, however its clinical use declined over the years.
Today MVV test is most commonly performed as part of the exercise tolerance tests,
where it is used as an index of maximum ventilatory capacity. Test consists in breathing
in and out deeply and rapidly for 12, 15 seconds. The expired volume during this short
period is then extrapolated
The most important measured parameter is the following:
MVV
Maximum Voluntary Ventilation
Perform a MVV test
1.
2.
3.
4.
Select Maximum Voluntary Ventilation from the test menu and wait for the
green led is prompted on the right side of the screen.
Press F2 and make the Patient breath as much deeply and rapidly as possible for at
least 12 seconds.
Press F3 or wait for automatic interruption (5 seconds without flow) in order to
visualise the V/t graph together with the main parameters compared to the predicted
values
To visualise the V/t graph and the main parameters press the follow buttons:
view Volume Time graph
5.
6.
7.
8.
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view data of the test
Press Alt+F3 to stop the acquisition discarding the results.
Repeat the test until it is correctly performed (ATS recommends 3 times).
Press Exit to visualise the test list carried out during current session together with
the results of the main parameters.
Select the test that you want to save (the Best Test according to the ATS criteria is
highlighted as default) and press OK.
Bronchial Provocation Test
Bronchodilator test
Note: Read carefully the
contraindications in Chapter 1.
Bronchodilators are administered routinely in the PFT laboratory to determine whether
airflow obstruction is reversible. Bronchodilators increase airway calibre by relaxing
airway smooth muscle.
The test consists of comparing results between the reference FVC (FVC PRE) and the
FVC POST performed after the administration of the drug. Increasing value of 13-15%
of FEV1, respect to the basal value (FVC Pre) is considered as a reversible condition.
Main parameters are the following:
DFEV1%pre
Change of FEV1 as a percentage of test PRE
DFVC%pre
Change of FVC as a percentage of test PRE
DPEF%pre
Change of PEF as a percentage of test PRE
Some authors states that the above mentioned parameters are too dependent from the
FVC Pre, hence latest reference (ERS93, [A comparison of six different ways of
expressing the bronchodilating response in asthma and COPD; reproducibility and
dependence of pre bronchodilator FEV1: E. Dompeling, C.P. van Schayck et Al; ERJ
1992, 5, 975-981]) recommend the following parameters:
DFEV1%pred Change of FVC as a percentage of predicted value
DFEV1%poss Change of FEV1 as a percentage of “possible value”
Methacholine and Histamine Bronchial provocation Tests
The most common indication for performing methacholine and histamine bronchial
challenges is to diagnose hyperresponsive airways. Some patients demonstrate normal
baseline pulmonary function despite complaints of “tightness” wheezing, cough, and a
little or not response to bronchoconstrictor. Other patients demonstrate spirometric
improvement after use of bronchoconstrictor have diurnal variation in peak flows. In
this groups aerosolised bronchial challenges are used to confirm a diagnosis of Asthma.
We can summarise the use of the test as follows:
1. Diagnose asthma
2. Confirm a diagnosis of asthma
3. Document the severity of hyperresponsivness
4. Follow changes in hyperresponsivness
When patients with hyperresponsive airways inhale certain pharmacologic agents (i.e.
Methacholine or histamine) the airways respond by constricting.
Test consists of executing repeated FVC following the pharmacologic agents inhalation
according to an established protocol. The fall of the FEV1 parameter is used to calculate
the bronchial hyperresponsivness. The most important parameter is the PD20 that is
amount of drug (mg/ml) that causes a reduction of 20% of the FEV1 respect the basal
value (without drug).
Main parameters are:
P10 Dose that causes a 10% fall of FEV1.
P15 Dose that causes a 15% fall of FEV1.
P20 Dose that causes a 20% fall of FEV1.
The representative plot is the Dose/response curve, showing the percentage variation of
FEV1 versus the Drug dose in logarithmic scale.
The program assumes as the baseline test the best FVC pre carried out during the
today’s visit. You can change the reference pre test editing the Post test.
The name of the drug, its quantity and its unit of measurement, can be typed
immediately before any FVC post manoeuvre (manual protocol) or can be stored in a
database of bronchoprovocation (File/Bronchial Provocation protocols Database…).
Chapter 6 - Spirometry - 71
Perform the test
(During 1st step only) select Protocol... from the Test menu and choose the name of the
bronchoprovocation protocol that you are going to use (manual protocol if you want to
type the information about the agent before any manoeuvre)
1. Select FVC post from the Test menu.
2. Select an existing protocol or click on “manual protocol”, and wait the green leds
turned on.
3. Press F2, or the button by side, to start the test.
4. Press F3, or the button by side, to achieve the test.
5. In order to visualise the V/t graph and the main parameters press the follow
buttons:
view Flow Volume graph
view data of the test
6.
7.
8.
9.
view bronchial provocation response
Press Alt+F3 to stop the acquisition discarding the results.
Repeat the test until it is correctly performed (ATS recommends 3 times).
Press Exit to visualise the test list carried out during current session together with
the results of the main parameters.
Select the test that you want to save (the Best Test according to the ATS criteria is
highlighted as default) and press OK.
Bronchial Provocation protocols Database
The response to a bronchoprovocator is usually assessed in terms of change in the
FEV1, vital capacity or airways resistance on the basis of serial measurements (FVC
manoeuvres) in which the results of the initial test constitute the reference values. The
international literature proposes several standardised protocols in order to address the
methodological issues of the various available techniques.
The possibility to store a bronchoprovocation protocol in a database is useful to simplify
and automate the sequence of operations that the Physician need to execute during the
bronchoprovocation tests.
The typical sequence of activities to carry out a bronchoprovocation test are:
1. Typing and storing a bronchoprovocation protocol in the database (usually only
once).
2. Selection of protocol among the list of the ones already present in the database
before carrying out the FVC post tests (the selection of “manual protocol” allows to
execute the test fully manually).
3. Performing the Post tests.
Enter a new Bronchial provocation protocol in the archive
1.
2.
3.
4.
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Select Bronchoprov. protocols database from the File menu.
Type the Protocol name, the Bronchoprovocator name and the unit of measurement
in the proper input fields.
If the bronchoprovocator has a cumulative effect select the cumulative check
button.
Enter the quantities for each step and press the button
.
Viewing results
All the visualisation functions refer to the test carried out by the Current Patient, whose
name is indicated on the left-side of the status bar.
To view tests results:
1. Select the Patients from the File menu
2. Select the patient corresponding to the test you want to view.
3. Select in the list box of the tests up to 5 tests of the kind (FVC, VC/IVC, or MVV)
and press OK.
To switch between graph and or data use the following buttons on the toolbar:
view Flow Volume graph (F5)
view Volume Time graph (F6)
view data of the test (F7)
view bronchial provocation response.
If you need more than one visualisation meantime use the New Window function from
the Window menu.
If you need to display a list of visits:
•
Select Visits list... from the File menu.
•
Type the name of the Company and/or the time interval desired or simply confirm
for the complete list.
Tests of the current patient
If a current patient has been selected you can quickly view his tests selecting Test
current patient... from the View menu.
Delete a test
1.
2.
Select Patients from the File menu or press the button by side.
Select the test that you want to eliminate from the list of the tests referred to the
Current Patient and press Delete.
Chapter 6 - Spirometry - 73
Printing results
You can print out in three different ways:
•
printing the Report
•
printing the Active Window
•
printing a series of reports
Printing Reports
To print a report of the current visit, select Print report… from File menu. The
software will choose automatically the best performed test.
The standard Report is composed by 1, 2 or 3 pages depending if you wish to printout
the FVC data and the graphs together on the first page or if you wish to printout the
bronchoprovocation response.
•
Selecting the option One page (no ATS) the report will contain, on one page, the
F/V and V/t graphs of the best test, overlapped on the FVC Post, the patient data,
the notes, the diagnosis and the test results.
•
Otherwise the report will contain two pages, the first with the patient data, the
graphs and the diagnosis, and the second one with the measured parameters,
according to the ATS recommendations.
• The 3rd page will contain the bronchoprovocation response.
Select the desired options:
FVC graph
Prints the F/V and V/t curves for the best FVC test.
One page (no ATS)
Prints data and graphs on the first page.
Response
Prints the bronchoprovocator response.
FVC post
Prints data and graphs for the Post FVC test (the test can be
selected among the test performed in the current visit).
Multi breath N2
Prints the best FRC test of the current visit.
wash out
Single breath O2
Prints the best CV test of the current visit.
Single breath CO
Prints the best DLCO with apnoea test of the current visit.
diffusing capacity
Single breath CO
Prints the best DLCO without apnoea test of the current visit
(no breath hold)
CO diffusing capacity Prints the best DLCO Steady State test of the current visit
Steady State
Respiratory drive
Prints the best P0,1 test of the current visit.
Preview
Views a report preview on the screen.
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Printing the active window
This printout function is only enabled when the active window (title bar highlighted) is
one of the following objects:
•
Any kind of Graph.
•
Numeric data
•
List of visit
To print the active window
1.
2.
Ensure that the active window is one of the preceding objects.
Select Print Active window from File menu.
Printing a series of reports
Sometimes it is useful to printout automatically a series of reports (all tests carried out
with the employees, all tests carried out in the today's session).
To print out proceed as follows:
1. Select Visit List from the File menu
2. Set the criteria of the visits to be added in the list (from, to,...)
3. Select Print Report from the File menu.
Electronic reports (*.pdf)
If an Adobe PDF writer “Printer Driver” is installed and set as the default printer, it is
possible to store the printout report automatically in any location of the HD or
eventually LAN paths according to a customizable filename format.
It is possible to define the created filename format selecting File/Page Set up... (see
Page set-up).
Export data
With this function you can export the test data in 4 different formats:
•
*.txt (ASCII)
•
*.xls (Microsoft Excel)
•
*.wk1 (Lotus 123)
•
*.xpo (Cosmed)
Export a test
1.
2.
3.
4.
Select Export tests from the File menu.
Select the test to export from the list box and press OK.
Type the name and the format of the file in the dialog Save as. If the ASCII format
is selected, the Text button in the dialog box Save as allows you to configure the
separators for character based files.
With the *.xpo Cosmed file format it is possible to import data from another Quark
archive. Press OK to confirm.
Select the folder for the export and type the file name. Press OK to confirm. A
status bar will show the file creation.
Chapter 6 - Spirometry - 75
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Lung Volumes
Lung volumes tests (N2 washout)
In the PFT lab the measurement of “Lung Volumes” usually refers to the measurement
of Total Lung Capacity (TLC), residual volume (RV), functional residual capacity
(FRC), and Vital Capacity (VC). These measurements are essential to assess lung
function, they are important for the diagnosis of restrictive disorders.
FRC is most commonly determined with one of three basic techniques:
1. Multiple-breath open circuit Nitrogen washout
2. Body Plethysmography
3. Multiple-breath closed circuit Helium washout
COSMED Quark PFT uses the nitrogen wash-out technique to measure Lung volumes.
This method involves removing or “washing-out” the N2 gas present in a patient’s lung
by having the patient breathe 100% O2 for several minutes (usually 7 minutes or until
the final concentration of N2 is below 1.5-2.5%). Since the whole expired nitrogen
come from the initial lung volume, a simple equation allows to get FRC value.
The main parameters measured during this test are:
FRC
Functional Residual Capacity
CEV
Total ventilated volume during the test
Wash-out time
Test duration
RV
Residual Volume
TLC
Total Lung Capacity
RV/TLC
Motley index
Recommendations
•
The system must be calibrated before each test (See Calibration chapter)
•
The flowmeter must be connected properly to the breathing valve and the soft
mouthpiece must be properly fixed to the corresponding adapter.
•
Check that the O2 cylinder is open and its output pressure is adjusted in the range 56 bar.
Setting N2 wash-out options
1.
2.
3.
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Select Settings... from Options menu.
Select Multi-breath N2 Wash-out
Set the desired value in all the fields described in the next table.
Option
End-of-test criterion
Description
FetN2 value under which the wash-out test is concluded
automatically
FRC Extrapolating
Enable the extrapolation of FetN2 to the end-of-test
criterion
Vt stability threshold
Recognition criterion of regular respiration
Breathing Depth
Range of respiration control bar during FRC (tidal
volume)
Breathing Frequency
Range of respiration control bar during FRC
(respiratory frequency).
Pressing the System… button, you can set the following options:
Option
Description
System dead space
Add the volume of the viral filter eventually used
O2 cylinder impurities
Refer to the used O2 cylinder analysis certification
Perform the test
1.
2.
3.
4.
5.
6.
Select Multi-Breath N2 wash-out from the Test menu and wait for the green led is
prompted on the right side of the screen.
Connect the patient to the breathing valve and invite him/her to breathe normally.
Wait for the message “carry out slow vital capacity” is prompted on the screen of
the PC and let the patient to perform a slow vital capacity.
Wait for a normal breathing pattern is again established and press Start (F2) to
begin the wash-out with oxygen.
Wait for the final Nitrogen concentration (FetN2) reaches a value lower than 2.5%
and press Stop (F3) to conclude the test.
In order to visualise the graph and the main parameters press the follow buttons:
view FRC graph
view Volume Time graph
view data of the test
view breath by breath data
At the end of the test, you can edit the test:
•
Display the test to be modified
•
Right click with the mouse and select Edit...to change the test properties (wash-out
volume, sample volume, effective breath hold time calculation...).
Chapter 7 - Lung volumes - 79
Closing Volume Test (CV)
The Patient perform one single inspiration of 100% O2 following a maximal expiration
(RV level) and then expires smoothly through a breathing system able to measure both
the instantaneous N2 concentration and expired flow.
The expired nitrogen is plotted on a N2/Volume graph from which test results are
obtained. The graph presents 4 different phases:
Phase I:
The gas expired during Phase I represents the oxygen coming from the
dead volume of the measurement system and the upper airways not
interested by any distribution phenomenon.
Phase II:
Shows the N2% rising belonging to the spaces connecting the upper
airways and the alveolar volume where the initial N2 has be diluted with
the inspired oxygen. In this phase the Anatomic Dead Space is calculated
(Fowler method).
Phase III: It is called Alveolar Plateau. It shows the average N2 concentration
resulting from the dilution of the air originally contained in the Residual
Volume with the inspired Oxygen. The slope of this plateau (about 1.5%
for normal subjects) is an useful index for assessing distribution disorders
(Patients affected by severe emphysema can reach 10% values).
Phase IV:
The end of Phase III corresponds to the beginning of the so called
Closing Volume which represents the last section of the Vital Capacity
before the Residual Volume. The quick increase of the N2% belongs to
the emptying of the latest alveoli, richest of N2 because not reached by the
inspired O2. Increased values of CV can be related to lung pathologies.
The main parameters calculated during this test are:
CV
Closing Volume
Delta N2%
Delta N2% between 750ml and 1250ml of expiration.
Recommendations
•
The system must be calibrated before each test (See Calibration chapter)
•
The flowmeter must be connected properly to the breathing valve and the soft
mouthpiece must be properly fixed to the corresponding adapter.
•
Check that the O2 cylinder is open and its output pressure is adjusted in the range 56 bar.
1.
Select Single Breath O2 from the Test menu and wait for the green led is prompted
on the right side of the screen.
Connect the patient to the breathing valve and invite him/her to breathe normally.
Wait for the message “carry out Slow Vital Capacity” is prompted on the screen of
the PC and let the patient to perform a slow vital capacity.
Wait for a normal breathing pattern is again established and press Start (F2) during
a maximal exhalation.
Ask him/her to inspire up to TLC level and then to expire slowly maintaining the
flow rate as much constant as possible (two lines corresponding to 250ml/min and
500ml/min can be used as a target interval).
On the right side of the graph it is displayed a colored column, representing the
instantaneous flow. This column is green if the flow is within the acceptable range,
otherwise it is red.
The test stops automatically.
In order to visualise the graph and the main parameters press the follow buttons:
Perform the test
2.
3.
4.
5.
6.
7.
View CV graph.
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view Volume Time graph
view data of the test
At the end of the test, you can edit the test:
•
Display the test to be modified
•
Right click with the mouse and select Edit...to change the test properties (wash-out
volume, sample volume, effective breath hold time calculation...).
Chapter 7 - Lung volumes - 81
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P0.1 Respiratory
drive
P0,1 (Respiratory drive)
Aim of the test
The test named P0,1 or Respiratory Drive consists of evaluating the reduction of
pressure caused by the patient's inhalation.
In order to evaluate the P0,1 the subjects breaths in a mouthpiece provided with a
shutter and a pressure detector, by determining a shut down of the respiratory ways for
100 msec at the beginning of the inhalation, its possible to measure the reduction of
pressure. The shut down is so short that the patient keeps breathing normally without
realising it. Many other measurement can be carried out making the patient inhale
increasing concentration of CO2 and verifying the results.
Setting respiratory drive options
1.
2.
3.
Select Settings... from Options menu.
Select Respiratory drive
Set the desired value in all the fields described in the next table.
Option
Vt Stability threshold
Description
Recognition criterion of regular respiration
Recommendations
•
Connect the P0.1 valve on the “breathing valve” connector on the front panel of the
Quark system.
•
Verify that the cylinder driving the P0.1 valve (O2-CO2) is open.
1.
Select Respiratory Drive from the Test menu and wait for the green led is
prompted on the right side of the screen.
Breath at rest until the message “Press F2...” is prompted.
Wait for the Patient establish a regular breathing pattern and press F2 whenever
you want to close the inspiratory valve for measuring the P0.1 parameter.
Repeat the above mentioned manoeuvre several time both in room air or with
enhanced CO2 inspiratory gas.
Press F3 to end the test.
Perform the test
2.
3.
4.
5.
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6.
To visualise the V/t graph and the main parameters press the follow buttons:
view P0.1 graph
view Volume Time graph
7.
view breath by breath data
Press the Abort button to stop the acquisition discarding the results.
Chapter 8 - P0.1 Respiratory drive - 85
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Lung diffusing
capacity
CO Diffusing Capacity (DLCO) Test
The process of diffusion is defined as the flow of particles from an area of higher
concentration to an area of lower concentration. The measurement of diffusion, as
performed in pulmonary function laboratories, provides information about the transfer
of gas between the alveoli and the pulmonary capillary blood. The two major gases
involved in lung diffusion (O2 and CO2) must move through two barriers: the alveolarcapillary membrane and the blood plasma-red blood cell barrier.
The rate of diffusion across these primarily liquid barriers is limited by the surface area
for diffusion, the distance the gas molecules must travel, the solubility coefficient of the
gases in the liquid, the partial pressure difference (gradient) between air and blood and
the density of each gas.
Measurements of the diffusing capacity is usually performed using Carbon Monoxide
(CO) because it has a great affinity for Haemoglobin (210 times that of O2), it is soluble
in blood and its concentration in venous blood is insignificant.
The main techniques are:
1. Single Breath with Apnoea (ATS/ERS standard)
2. Single Breath without Apnoea (requires a fast response CO analyser)
3. Multiple Breath in Steady-State
Setting DLCO options
1.
2.
3.
Select Settings... from Options menu.
Select Single Breath CO diffusing capacity
Set the desired value in all the fields described in the next table.
Option
Apnoea time
Effective time
Vt Stability threshold
Description
ATS and ERS standard: 10 s
Ogilvie1, Jones & Meade2, ESP3
Recognition criterion of regular respiration
1
from the beginning of the inspiration till the beginning of sampling
2
from 70% of inspiratory time, to 50% of sampling
3
from 50% of Inspired Volume to the beginning of sampling
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Pressing the System… button, you can set the following options:
Option
Description
System dead space
Add the volume of the viral filter eventually used
O2 concentration
O2 content of the used mixture (ATS 21%, ERS
17%)
Pressing the Patient… button, you can set the following options:
Option
Description
Physiologic dead space
calculation criterion (ATS=2.2*weight, manual)
Haemoglobin
calculation criterion (ATS=14.6 adult men, 13.4
women and children)
Carboxyhaemoglobin
digit the percentage value
Recommendations
•
The system must be calibrated before each test (See Calibration chapter)
•
The flowmeter must be connected properly to the breathing valve and the soft
mouthpiece must be properly fixed to the corresponding adapter.
•
Check that the DLCO cylinder is open and its output pressure is adjusted in the
range 5-6 bar.
DLCO with breath-hold (standard technique)
The Patient carry out a maximal inspiration of a mixture containing a low concentration
of CO (0.3%) and a tracer gas which is not metabolised (CH4, Methane); then he is
asked to breath hold for 10 seconds (the expiratory valve is kept closed) and finally he
is allowed to expire slowly up to the Residual Volume (the expiratory valve is opened).
Analysing the concentrations of CO and the Tracer gas (CH4) belonging to a portion of
the expired volume (collected volume) obtained by discarding the beginning of the
expiration (wash-out volume), the test indexes are determined.
The “wash-out volume” (0.75-1 L for normal subjects, 0.25-0.5 L with reduced Vital
Capacity ), the “collected volume” (0.5-1 L) and the calculation of the “breath hold
time” (ESP, JONES, OGILVIE) have been standardised by both ATS and ERS.
If fast response CO and CH4 analysers are used it is possible to optimise the selection of
the “wash-out” and “collected” volumes according to the Vital Capacity of the subject.
This is usually achieved operating graphically on the CO/CH4 graphs.
Repeating the DLCO test with different mixtures of inhaled gas it is possible to
separates the contributes of the alveolar membrane (Dm) and the Capillary Blood
Volume (Vc)
The main parameters of the DLCO test are:
DLCO
Lung Diffusing Capacity
DLCOcorr Lung Diffusing Capacity corrected for Hb, COHb and PB
VA
Alveolar Volume
DLCO/VA Krogh Index
Dm
Alveolar Membrane
Vc
Capillary Blood Volume
DLCO with apnoea (standard method)
1.
2.
3.
Remove the sampling line from the flowmeter
Select Single Breath CO diffusing capacity from the Test menu
Confirm or in case change the test options:
- Breath hold time
- Simulated test (it allows to carry out the manoeuvre without inhaling gas, useful
for teaching purposes)
- Hb (haemoglobin)
- Anatomic dead space
Chapter 9 - Lung diffusing capacity - 89
4.
Wait for the zeroing of the analyser is completed and plug in again the sampling
line in the flowmeter
5. Connect the Patient to the mouthpiece and let her/him breathing at rest until the
message “Carry out Vital Capacity” is prompted
6. Carry out a Slow Vital Capacity if desired (this is not necessary for completing the
DLCO test)
7. Invite the Patient to exhale up to Residual Volume and press F2 during the
maximal expiration
8. Coach the Patient to inhale up to Total Lung Capacity and to hold the breath until
the expiratory valve will be automatically open; a quick full expiration shall follow
and the test will be completed.
A dashed line indicates the 90% of the Best Vital Capacity (if a FVC or SVC test is
available in the archive, otherwise it indicates the 90% of the Predicted VC), in order to
verify the correctness of the manoeuvre.
Double-click with the left mouse button in order to modify the test options (wash-out
volume, sampling volume, calculation of the real apnoea time…). Checking the box
ATS95 Criteria, it is possible to set automatically 1 litre for wash-out and sampling
values, according to the ATS95 criteria.
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DLCO without apnoea (“intrabreath” method)
1.
2.
3.
Remove the sampling line from the flowmeter
Select Single Breath CO diffusing capacity from the Test menu
Confirm or in case change the test options:
- Breath hold time (deselect the check box)
- Simulated test (it allows to carry out the manoeuvre without inhaling gas, useful
for teaching purposes)
- Hb (haemoglobin)
- Anatomic dead space
4.
Wait for the zeroing of the analyser is completed and plug in again the sampling
line in the flowmeter
5. Connect the Patient to the mouthpiece and let her/him breathing at rest until the
message “Carry out Vital Capacity” is prompted
6. Carry out a Slow Vital Capacity if desired (this is not necessary for completing the
DLCO test)
7. Invite the Patient to exhale up to Residual Volume and press F2 during the
maximal expiration
8. Coach the Patient to inhale up to Total Lung Capacity and to expire slowly
maintaining the flow rates within the two target lines shown on the real-time
window until the Vital Capacity has been exhaled.
A dashed line indicates the 90% of the Best Vital Capacity (if a FVC or SVC test is
available in the archive, otherwise it indicates the 90% of the Predicted VC), in order to
verify the correctness of the manoeuvre.
Double-click with the left mouse button in order to modify the test options (wash-out
volume, sampling volume, calculation of the real apnoea time…).
Multiple breath DLCO test (“Steady-State” method)
In this test, the patient breathes regularly during the whole test (about 8 min): graphs
and results will be displayed breath by breath.
Normally, during the first 2 minutes the patient inhales ambient air, then such a mixture:
0.1% CO, 0.1% CH4, 21% O2, N2 balance.
1. Remove the sampling line from the flowmeter
2. Select CO diffusing capacity steady state from the Test menu
4. Wait for the zeroing of the analyser is completed and plug in again the sampling
line in the flowmeter
5. Connect the Patient to the mouthpiece and let her/him breathing at rest until the
message “Carry out Vital Capacity” is prompted
6. Carry out a Slow Vital Capacity if desired (this is not necessary for completing the
DLCO test)
7. While the patient is exhaling, press F2 in order to start the mixture
8. When the steady state is reached, press F3 to end the test.
Right-clicking you can generate new graphs and parameters to be displayed, both during
the test and at the end.
Chapter 9 - Lung diffusing capacity - 91
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MIP/MEP (option)
MIP/MEP test
The MIP/MEP test measures the maximum inspiratory/expiratory pressure of the
patient. He/She breathes normally until the start of the test, perform a maximal
expiration/inspiration and then inspires/expires with the maximum force against a valve
which does not allow the air flow.
The measured parameters are:
MIP
Maximum inspiratory pressure
MEP
Maximum expiratory pressure
How to perform the test
1.
2.
3.
4.
5.
6.
7.
8.
9.
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Disconnect the breathing valve from the front panel of the Quark
Connect the MIP/MEP valve to the breathing valve connector on the front panel of
the Quark and insert the flowmeter into the valve. Use a rubber mouthpiece
connected to the antibacterial filter and nose clip.
Select MIP/MEP from Test menu and wait for the green led is prompted on the
right side of the screen.
Breathe normally for some time.
Carry out a maximal expiration (for the MIP) or a maximal inspiration (for the
MEP).
Press F2 during the expiration/inspiration.
Inspire/Expire with the maximum force against the shutter until it opens
automatically.
Repeat the same procedure for the expiratory (inspiratory) maneuver. It is not
necessary to repeat the test since both MEP and MIP can be conducted during the
same acquisition.
Press F3 or wait the end of the test, so that the software displays the graphs, the
measured parameters, and the predicteds values.
Pulse oximetry
(option)
The oximetry test
The oximetry test measures the haemoglobin saturation, i.e. the percentage of the blood
haemoglobin bearing oxygen. The test can be performed at rest or during/after a light
exercise phase (cycling, jogging).
This test is not intended for measuring the oximetry during exercise tests. For this use,
see chapter Exercise testing.
The test is completely automatic.
The measured parameters are:
SpO2
Haemoglobin saturation
HR
Heart rate
How to perform the test
1.
2.
3.
4.
5.
6.
7.
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Connect the pulse oximeter to auxiliary RS232 port on the back of the Quark PFT.
Connect the probe to finger or ear of the Patient (different probes are available).
Select Oximetry from the Test menu and wait for the green led is prompted on the
right side of the screen.
In the first part of the test the HR and SpO2 values, together with a
plethysmographic graph, are displayed. The graph monitors the quality of the
signal.
Wait for an acceptable quality of the real-time trace and press F2 or the Start
button to start the data acquisition.
Every 5 seconds, the HR and SpO2 values are stored.
After the test, press F3, so that the software displays the graphs and the measured
parameters.
Airway resistance
measurement
(option)
The airway resistance measurement test
The measurement of the airway resistance is an important determinant for the
assessment of the respiratory system. Traditional methods of measurement are based on
body plethysmography which, although highly standardised, require a certain degree of
patient’s co-operation.
In many cases (critical illness, acute asthma, geriatric and unconscious patients,
neonates, pre-school children) this is not possible and different measuring methods are
required. Instruments based on the interrupter technique are good alternatives to body
plethysmography.
The idea behind the interrupter technique is that alveolar pressure will rapidly
equilibrate the pressure at the mouth during a transient airflow interruption. Thus if we
provoke an airflow interruption and measure the pressure at the mouth immediately
after the interruption, we are able to express the airway resistance as the ratio between
the pressure at the mouth (identical to alveolar one) and the value of the flow before the
interruption.
The Appendix reports bibliographic references, which demonstrate a high
reproducibility and correlation between the values so measured and those measured by
body plethysmography.
The measured parameters are the following:
Rocc_ex
Expiratory resistance
Gocc_ex
Expiratory conductance
Rocc_in
Inspiratory resistance
Gocc_in
Inspiratory conductance
Preparing the ROCC module and connecting to the unit
1. Connect the three parts of the ROCC module as in the picture
by side.
2. Connect the module to the Quark PFT unit through the
Flowmeter connector, on the front panel.
1. Occlusion valve
2. Reader
3 PNT
Performing the test
1.
2.
Select Rocc from the Test menu.
The Test option window will open
By means of this window you can set the following options:
• Random (automatic) or manual occlusion
• Occlusion activated on the inspiration or expiration
• Value of the flow at which the occlusion is activated
• Use of COSMED antibacterial filter
3.
4.
5.
6.
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• Parameters for the back-extrapolation algorithm.
Wait for the end of the calibration.
Let the patient to breathe inside the module.
If manual occlusion is selected, press F2 each time you desire to activate an
occlusion.
After each occlusion, you are asked if accept or discard the result.
7.
8.
End the test by pressing F3 or the button by side.
In order to view the graphs or the main parameters, press the following buttons:
view the ROCC graph
view an average of the measured parameters
view all the performed steps
9.
Press Alt+F3 or the button by side to stop the acquisition discarding the results.
Chapter 12 - Airway resistance measurement (option) - 99
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Exercise testing
Recommendations for the exercise testing
The evaluation of the cardiorespiratory function
The physical training requires the interaction of physiological mechanisms that allow
the cardiovascular and respiratory systems to supply the increasing demand of energy
due to the contraction of the muscles.
During the training the systems are both engaged, an adequate answer to the effort is the
measure of theirs health state.
The increase of the metabolic rate, during the exercise, needs an appropriate increase of
oxygen in the muscles. At the same time, the CO2 muscles production must be removed
in order to avoid the lactic acid making.
To satisfy the increase in the gas exchange, necessary to the muscles during the
exercise, is requested the intervention of many physiological mechanisms. This process
involves lungs, the pulmonary circulation, the heart and the peripheral circulation.
Precautions
The physician has the responsibility that the patient subjects to the test is a suitable
person able to execute an effort test.
Laboratory
The room, in which the test is performed, must be big enough to contain the whole
necessary equipment, allowing an easier accessibility to the patient in case of
emergency.
In the room should be placed a thermometer and a hygrometer; the heart frequency and
the perceived values of the effort rise as much as the ambient temperature increases, and
the variability of the cardiovascular response grows for humidity values higher of 60%.
Generally it is considered 22°C the temperature adequate for the test execution, even for
short efforts, values till 26°C can be considered acceptable in presence of an efficient air
ventilation.
Ending the test
The patient should be monitored with ECG for at least 8 minutes, in resting conditions
or until he returns to the pre-exercise conditions.
Preparing the patient
To enhance the value of a diagnostic test it’s very important patient collaboration. In
most cases a well-informed patient will make a better effort (in relation to his
conditions) and will allow a reliable interpretation of the test. For this reason every
ergometric test must be preceded from a precise training of the patient.
Before testing
The physician applying the exam must be provided with a written request including a
brief description of the diagnosis (confirmed or suspected ), the request’s reason and the
patient therapy carried out showing the dose and time of the drug assumption.
To standardise the response to the test and reduce the patient’s anxiety it’s suggested to
provide him either written (before the exam) or oral (at the same time of the test)
information. At the scheduling time detailed instructions should be delivered to the
patient, consisting in smoke and food abstinence three hours before an ergometric test,
or eight hours before a scintigraphic test.
Test are usually executed supporting the therapeutic outline in progress, but sometimes
it could be necessary to stop some drugs, such as b-block or calcium antagonist, which
could impair the effort response reducing the diagnostic accuracy of the exam.
The patient must wear comfortable suit and gymnastic shoes and two hours before test
stop any kind of drugs, eat light and avoid coffee and smoke.
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It’s very important acquire information on the patient’s clinical past before performing
the test. Keep attention in particular way to the use of drugs, tobacco, to the physical
fitness and symptoms produced with the exercise.
Patient assent
The patient is informed that he will be submitted to a maximum effort, which could be
stopped at any moment, and of the risks of the test execution.
Ending the test
Test may end when the maximum value of the oxygen consumption has been reached
and the patient’s response established.
Chapter 13 - Exercise Testing - 103
Start Testing
Before starting exercise test type a new patient information or choose one from the list
of patient in the file. As soon as a patient has been entered the software is ready to start
a test. The name of the active patient is shown on the status bar of the program window.
Start a test
1.
2.
Calibrate the analysers as described in the Calibration chapter.
Choose Execute Test from the Test menu.
3.
Enter or modify the antropometric data of the patient and select the options you
need to carry out the test . To use a specific protocol choose it in the list box and
press OK to confirm.
Select the ergometer you need to control
The software environment will change showing a new Menu bar and toolbar while
the first data will be displayed in a table format.
Note: Selecting “Simulated
test”, the software allows to
use the gas calibration in order
to perform the test. This is
useful if the user would check
the accuracy of gas
measurements.
4.
5.
6.
At this point the software starts showing data on the monitor but without saving
them, this in order to monitor the patient before starting the test. To start storing
data press F2.
Abort the test without saving data
Choose Abort from the Test menu or press Alt+F3.
End the test saving data
1.
2.
Choose End from the Test menu or press F3.
Choose Yes to end the test or No to continue.
View data in real-time
The visualisation features and capabilities of the data and graphs are identical to the
ones described in the Data management chapter. Starting the test a small window will
appear on the right corner displaying time, bmp and, if selected before, the ergo
protocol and trainer.
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View graphs in real-time
1.
2.
Choose Graph from the View menu.
Follow the instructions described in data management section to edit the graphs.
Parameters to view
While the test is running, it is possible to choose the parameters to view.
1. Select Parameters to view/Test execution… from the Options menu.
2. Select the parameters and confirm.
Manual protocol
If you are using the Quark with a treadmill without serial interface, it is possible to enter
manually from the PC the event, the phase and the marker.
Tip: pressing the Shift key
while choosing the marker
option will allow you to enter
the label for that marker.
Enter Load and Phase
1.
2.
During the test select Load from the Events menu.
Select the phase and/or type the value of the load and press OK to confirm.
Set the markers
Select Marker from the Events menu.
Automatic protocol
The software allows to automatically control the ergometer according to the protocol
previously selected. Anyway it is allowed to change it even after the test is started.
Modify the load during the test
1.
2.
During the test choose Ergometric protocol from the Events menu.
Select the row corresponding to the desired load and press OK to confirm.
Set the BPM alarm
The software allows the user to set the alarm level for the heart rate, in order to monitor
the patient response.
Enter the BPM
1. Choose BPM alarm from the Events menu.
2. Set the alarm by moving the scroll bar and press OK to confirm.
It also allows to enable or disable the acoustic alarm by the option "Acoustic alarm".
Chapter 13 - Exercise Testing - 105
Data management
As soon as the test has been completed, all data stored can be retrieved for a complete
management.
Viewing data
Data can be viewed in the following formats:
Table form
numeric values of the various parameters (columns) corresponding to
each step (rows).
Graphic form
graphical presentation on Y1, Y2, X charts.
Summary
results of the test and statistical analysis of the blocks.
Predicted
predicted values, maximum value measured.
View data in table form
1.
2.
Select Data… from the View menu.
Select the test to visualise in the list box and press OK
Note: Double-click in the
window to open the edit test.
Creating graphs
The software is provided with powerful functions for creating charts. You can add
custom graphs to create exactly what you need.
View data in graph form
1.
2.
3.
Choose Graph… from the View menu.
Select the tests to visualise from the list and press OK
Choose the parameters you require on the X, Y1 and eventually for Y2; select if
necessary some of the following options by pressing the more button and press OK
to confirm.
It is possible to access quickly 5 common graphs from the View/Graph… dialog box.
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Note: Double-click in the graph
window to open the edit test
Right-clicking, the graph can be exported in bmp file format.
Customise the graphs
1.
2.
With a graph on the screen, choose Customise graph from the View menu.
On the Customise graph dialog box, select options to obtain the wished graph.
Option
Function
Grid on X, Y axes
show the grid lines in correspondence with x or y axes that
make the graph easier for you to analyse data.
maximum and minimum values of the graph will be measured
automatically.
points with 0 value measured won't be shown.
make the graph scattered.
highlight with a symbol all steps of the test in which the marker
button was pressed.
makes the graph a square
exclude from the graph all points of the recovery phase.
marks each point with a symbol
allows to set manually the axes values.
Set the axes' scale step.
Autoscale
Ignore 0
Not interpolated
Marker
Squared
Without recovery
Mark points
Min. Max.
Step
Switch from graph to data and vice versa
When the active window is a graph (or a report in data form), it is possible to view very
quickly the data (or the graph) corresponding to that test.
Choose Current test data (if the active window is a graph) or Current test graph…
(if the active window is a data report) from the View menu.
Chapter 13 - Exercise Testing - 107
Viewing predicted values
For some parameter it is possible to compare the maximum value measured during the
test with its predicted value and the LT value both in percentage and absolute.
View predicted values
Choose Predicted from the View menu.
Anaerobic (Lactate) Threshold detection
The software allows to detect the Lactate Threshold (Anaerobic Threshold) according to
the "Modified V-slope method" reference. The LT can be detected both manually and
automatically.
View the Lactate Threshold
Choose Lactate Threshold from the View menu.
Detect the Lactate Threshold
1.
2.
3.
4.
Choose Calculate LT from the Test menu.
For calculating it automatically on the "Lactate Threshold" dialog box click on the
Auto detect button.
For adjusting manually the point you want to detect, move the scroll bar on the
dialog box by pressing the arrow buttons. Data and graph of the LT will be
automatically redrawn.
Press Ok button to save your choices.
Note: Double-click in the
window to open the
corresponding dialog box.
Customise graphs for the LT viewing
The software allows to customise two of the three graphs for the LT visualisation.
1. Choose Lactate Threshold from the Options menu.
2. Choose the parameters you want to be shown on the LT window and press OK to
confirm your choices.
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Fittings
The purpose of the fitting function is to find the function that fits as better as possible
the measured data.
The software allows to fit data according to 3 different functions:
Model
Function
Algorithm
Available for
Linear
Y=A*X+B
Least squares
Any Y vs any X graph
Mono-Exp Y=A+B*exp[(t-t0)/tau] Levemberg Marquardt Any Y vs Time Graph
Mean value
This function is available only if the active window is a single Y graph (i.e. VO2 vs time
or VO2 vs Load).
Fit a graph with a linear regression
1.
2.
3.
4.
5.
6.
Make active the graph window (any Y vs any X graph).
Right-click and select Fitting.
Choose Linear in the type combo box
Select the first point (X1) moving the mouse on the desired place in the graph
pressing the Left key or using the + and – keys.
Select the second point (X2) moving the mouse on the desired place in the graph
pressing the Right key or using the + and – keys.
Press OK to confirm.
Fit a graph with a Mono-exponential regression
1.
2.
3.
4.
5.
6.
7.
Make active the graph window (any Y vs any X graph).
Right-click and select Fitting.
Choose Mono-exponential in the type combo box
Select the first point (X1) moving the mouse on the desired place in the graph
pressing the Left key or using the + and – keys.
Select the second point (X2) moving the mouse on the desired place in the graph
pressing the Right key or using the + and – keys.
Enter (if necessary) the initial values of A, B and TAU (these are the values from
which the iterative algorithm starts in order to reach the best values; the closer are
the initial coefficients to the best ones the higher is the possibility to reach the best
fit).
Press OK to confirm.
Chapter 13 - Exercise Testing - 109
Calculate the "Mean Value"
1.
2.
3.
4.
5.
6.
Make active the graph window (any Y vs any X graph).
Right-click and select Fitting.
Choose Mean value in the type combo box
Select the first point (X1) moving the mouse on the desired place in the graph
pressing the Left key or using the + and – keys.
Select the second point (X2) moving the mouse on the desired place in the graph
pressing the Right key or using the + and – keys.
Press OK to confirm.
Note: The results of the O2 Fittings function are not stored therefore, in order to keep
the information, print the page using File/print Active Window.
Oxygen Kinetic
This function is available only if the active window is a VO2 vs time graph and it has a
sense only with Constant Load Exercise Tests.
The aim of this function is to find the dynamic response of the rising and falling edges
of the VO2 together with the Oxygen Deficit and Oxygen Debt.
Run the O2 Kinetic function
1.
2.
3.
4.
5.
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Make active a VO2 vs Time graph window.
Press the right key of the mouse and select O2 Kinetic.
Select the beginning of the exercise phase (t1) moving the mouse on the desired
place in the graph pressing the Left key or using the + and - keys.
Select the beginning of the exercise phase (t2) moving the mouse on the desired
place in the graph pressing the Right key or using the + and - keys.
Enter (if necessary) the initial values for A, B and Tau (these are the values from
which the iterative algorithm starts in order to reach the best values; the closer are
the initial coefficients to the best ones the higher is the possibility to reach the best
fit) and press OK. You can lock data checking the relative field
Information about the Test
The Test Information dialog box shows all the information concerning environmental
data, patient data and some data about the test
View the Information
Choose Information from the View menu.
Modify the information
1. Press the Modify button on the Information dialog box.
2. Change the values you want to modify and press OK to confirm.
The software allows to assess the energy expenditure and metabolism substratum. In
order to measure FAT and CHO, type the UN (Ureic Nitrogen) value into the field. All
the nutritional parameter will be recalculate considering the UN value.
Summary
The summary feature allows to summarise test results according to the workload and
phase during the test.
View the summary
1.
2.
Choose Summary from the View menu.
The summary of the current test (active window) will be displayed.
Tip: double-clicking on the
Summary window the
function Options/Summary
is activated by which you
may configure the structure
of the data.
Print the data
It is possible to print graphs and data by means of two functions: Print report and
Print current window. The last one is active only if the active window is a graph or a
data report.
Chapter 13 - Exercise Testing - 111
Print the current window
1.
2.
3.
Be sure that the current active window is the graph or the report you desire to print.
Select Print current window from File menu.
Press OK to print, or Setup to customise the print.
Print the report
1.
2.
3.
Select the report to be printed from File menu.
Press OK to print, or Setup to customise the print.
To only view the report, without printing it, press Shift during the selection.
View the report
This function allows to show a preview of a selected report.
1. Select Report from the View menu.
2. Select the test and the report to visualise and press OK to confirm.
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Data Editing
The software allows the user to edit the data acquired during the test in the following
ways:
Nota: In Data view, doubleclick in the window to enter
in “Data Editing”.
•
deleting one or more steps
•
editing row data
•
input new parameters
•
data filtering (averaging or smoothing)
• advanced data elaboration
After data elaboration it is always possible to restore the original data file by pressing
the Restore button .
If you want to save permanently all the changes, press Overwrite; being aware this
function replaces the original test definitely.
Editing values and input numerical values
1.
2.
Choose Edit test from the Test menu.
Select the cell containing the value you want to replace with others values and press
OK to confirm the editing.
The software will recompute all the parameters. Both the tables and the graphs will be
automatically updated.
Data filtering
1.
2.
3.
4.
Choose Edit test from the Test menu.
Press the button Filtering and choose the option Discard invalid steps to
automatically eliminate all the invalid steps
Press the button Filtering and choose the option Averaging and type the desired
value for points Ave/smooth to perform an averaging of the all acquired steps. This
feature reduces the size of the original test.
Press the button Filtering, select the option Smoothing and type the desired value
for points. This feature doesn't reduce the size of the original test, although it
smoothes the fluctuation of data.
Chapter 13 - Exercise Testing - 113
Using the User fields
The software is provided with three free fields in which the user may enter values
coming from others devices such as lactate, blood pressure etc.
To define the user fields:
1. Choose User Fields from the Options menu
2. Type the desired text in the input fields and press OK.
To enter values in the user fields:
1. Choose Edit test from the Test menu.
2. Scroll horizontally until the fields USER 1, 2 and 3.
3. Enter the desired values and press OK to confirm.
Deleting steps
This feature is useful whenever some steps acquired during the test are to be discarded
(steps acquired before the start of the test, patient disconnected from the face mask....).
1. Choose Edit tests from the Test menu.
2. Position the cursor on the step you want to delete and press the button Delete step.
Advanced Editing
This feature allows to perform some advanced editing of the data stored in the software.
1. Choose Edit test from the Test menu.
2. Press the Advanced button and select from the following options:
Option
Function
Delete steps
Smoothing
Edit parameter
deletes the steps meeting the selection criteria
applies a moving average to the selected parameter
edits a parameter according to the selected criteria
Edit parameter
Specifications
Value
Correction %
replaces the value of the selected parameter with a new one.
applies a percentage correction to the value of the selected
parameter.
adds an offset to the value of the selected parameter.
replaces the value of the selected parameter with a
mathematical function.
Offset
Formula...
Time range
Specifications
From, To
All steps
specifies the time range.
applies the editing from the beginning to the end of the test.
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Apply to
Specifications
Parameter
>, >=, =, <, <=, <>
specifies the reference parameter
higher than, higher or equal, equal to, lower than, lower or
equal, different
specifies the value (mathematical expression) compared
with the value of the specified parameter.
do not use any selection criteria.
Value/Formula…
All steps
Restore the original test
To cancel all the editing, in the "Edit Test" dialog box press the Restore button, confirm
your choice by pressing yes.
Overwrite the original test
To save all the editing, replacing the original test with the modified one, in the "Edit
Test" dialog box press the Overwrite button, confirm your choice by pressing yes.
Customise the desktop
Customise the display colours
1.
2.
3.
Select Colors from Options menu.
Select the item to be modified.
Press Change and select the desired colour.
Smart edit
This function is useful to correct data from artefacts; the noise affecting the measured
data can be reduced in 2 different ways:
Graphical noise suppression
using the mouse
Threshold noise suppression
applying a filter to the measured data
Apply the graphical noise suppression
1.
2.
3.
4.
5.
6.
Make active a graph or a data window corresponding to the test that you want to
modify.
Press the right key of the mouse and select Smart Edit.
Select the parameter that you want to modify.
Point the mouse on the position where the graph presents the artefacts, click the
Right key and, keeping pressed the key, drag the point on the desired place.
If you want to cancel the edit press the Left key of the mouse.
Repeat the above mentioned procedure for the all parameters and press OK.
Apply the threshold noise suppression
1.
2.
3.
4.
5.
6.
Make active a graph or data window corresponding to the test that you want to
modify.
Press the Right key of the mouse and select Smart Edit.
Select the parameter that you want to modify.
Set a Noise(%) Threshold (as a percentage of the parameter value) above which
any peak will be considered an artefact.
Press Execute and eventually Undo if you are not satisfied.
Press OK to confirm.
Chapter 13 - Exercise Testing - 115
Customise the parameters
The software allows the user to create customised parameters and predicted values,
derived from the standard parameters (the ones that are calculated by default) through
any mathematical formula.
All the customised parameters can be used freely for viewing and printing purposes.
Create a new parameter
1.
2.
3.
4.
Choose Customise parameters from the Options menu.
Press the New button if you want to create a new parameter or Modify if you want
to modify an existing one
Type the desired value in the fields "Name", "unit of meas", "integers", "decimals"
and "summary" (to present the parameter in the summary) and press the Formula
button.
Insert the mathematical formula by using the appropriate tools and press OK twice
to confirm.
Create a new predicted parameter
1. Choose Customise predicted from the Options menu
2. Press the New button if you want to create a new parameter or Modify if you
intend to modify an existing one
3. Type the desired value in the fields "Name", "unit of meas", "integers", "decimals".
4. Select the group of the predicted values from the options boxes.
5. Select the reference parameter in the "Compared to" list box.
6. Press the buttons in the calculation group and insert the mathematical formulas for
men and women, adults and paediatrics. Press OK twice to confirm.
Once you create the new predicted you can see it in the predicted window.
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Exporting data
With this function you can export the tests data and parameters in different file formats:
•
*.xpo (Cosmed proprietary file format)
•
*.txt (ASCII)
•
*.xls (Microsoft Excel)
•
*.wk1 (Lotus 123)
Export a test
1.
2.
3.
4.
Choose Export Tests from the Test menu.
Select the test to export from the list box and press OK to confirm.
Select the file output format from the list box, click on *.xpo,*.txt, *.xls or *. wk1.
If you selected ASCII format, by clicking on Text button you can then select the
Thousands sep. and Column sep. according to the program you want to use. With
the xpo Cosmed format you can import/export the tests performed on another
Quark equipment.
Select the folder, type the file name and press OK to confirm.
Note: The DDE function is
available only if the user PC
DDE with Excel
has Microsoft Excel
installed.
If Microsoft Excel
is installed on your PC, you can export a test simply pressing a
button on the toolbar.
To send a test to Excel, select Send to Excel from the Test menu.
The program will show a status bar indicating the data transmission to Excel. At the end
of the process a new sheet with all test data will be opened ready to be edited with the
powerful functions of Microsoft Excel.
Chapter 13 - Exercise Testing - 117
Creating Test Protocols
The software allows to create different exercise protocols to use during the test. The
load of the ergometer is automatically controlled by the software that change it
according to the defined protocol.
Create a new protocol
1.
2.
3.
4.
5.
6.
7.
8.
9.
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Choose Real Time > Ergom. Tests Protocols from the Options menu.
Press New and enter a name for the protocol.
In the field "Message Time" type a number that means to get a message to advise
when switching to the next load.
Enable the "Drive Ergometer" check box to let the software control the ergometer.
Select the "Initial Command" if the ergometer need it.
Enabling the option "Relative Increments", the loads refer to the previous step.
Press Generate and enter the values to generate a protocol from only one load (i.e.
30 Watt each minute for a total of 20 steps) and press OK to confirm.
Press Add if you want to add a new step.
To edit a step, select it from the list and change the relative values in the Edit boxes
below the list. Press the Tab button to save changes.
To delete a step, highlight the step and press Delete.
Software configuration
The software can be customised as you wish. Most of the feature are easily editable to
be tailored according to different purposes.
Data viewing
The software allows to calculate a huge number of parameters; it is advisable, in order
to simplify the analysis of the results, view in the data window the only desired
parameters.
Select the parameters to view
1.
2.
3.
Choose Parameters to view/Test visualisation… from the Options menu.
Select the parameters you require to view.
Press OK to confirm the selected configuration.
Select the parameters to view during the test
1.
2.
3.
Choose Parameters to view/Test execution… from the Options menu.
Select the parameters you require to view.
Press OK to confirm the selected configuration.
Sort the parameters
It is possible to sort the parameters (both for viewing and printing purposes) according
to the desired order.
1. Select Sorting parameters from the Options menu.
2. Move the parameters in the order you want by pressing and holding the left mouse
button.
3. Press OK to maintain the current configuration.
Steady State
The program has an algorithm to tag sets of steps as Steady State.
The algorithm considers belonging to the Steady State the only consecutive steps that
meet the following conditions:
•
The value of VO2, VE and R do not vary from their mean values more than
Threshold (%);
•
The number of consecutive steps that met the preceding criteria are at least
Minimum number of steps.
Customise the Steady State detection criteria
1.
2.
Choose Steady State from the Options menu
Type the desired values for Minimum number of steps, VO2 threshold (%), VE
threshold (%) and R threshold.
The steps which satisfy these conditions will be highlighted with a yellow bar.
Chapter 13 - Exercise Testing - 119
Printout reports
The software allows the user to printout data and graphics according to 4 customisable
reports. Further it allows the user to customise a printout header that will be printed in
each page.
Set up the printout
1.
2.
3.
Choose Reports from the Options menu.
Define the desired features of the report and confirm. Enabling the option "Graphs
in one page" all the graphs selected in the report will be printed in one page.
Type the name you want apply to the report and press OK to save changes.
Select parameters to be printed
Quark allows to print a large number of parameters; it is advisable, in order to simplify
the analysis of the results, to printout desired parameters only.
1. In the report configuration window select Parameters.
2. Select the parameters you require to be printed in the data printout. The number of
parameters which can be printed depends upon the size of the paper in use (see
Printer Layout) and from the orientation of the sheet.
3. Press OK to confirm the selected configuration.
Customise the printout header
1.
2.
3.
4.
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Choose Printout header from the Options menu.
On the "Report Header" dialog box type the text of the header.
To insert an image click the Logo button. An image editor will be opened, draw the
own logo and close the image editor to save changes.
Press OK to save the Printout header.
Electronic reports (*.pdf)
If an Adobe PDF writer “Printer Driver” is installed and set as the default printer, it is
possible to store the printout report automatically in any location of the HD or
eventually LAN paths according to a customizable filename format.
It is possible to define the created filename format selecting Options/Printout
header..., and then Name format…
Print the current window
The print current window function is enabled when the active window is a graph or a
data report.
1. Select Print current window from File menu.
2. Press OK to print, or Setup to customise the print.
Print the customised report
This function is enabled only after having customised a report.
1. Select the customised report from File menu.
2. Set the sheet format and press OK.
Chapter 13 - Exercise Testing - 121
Events management during exercise testing
Flow Volume loops
This test is useful during exercise to detect abnormalities in the mechanics of ventilation
in patients with pulmonary/ventilatory limitations to exercise.
The test consists in acquiring some flow/volume loops during exercise at different
workloads and overlapping them on the rest maximal flow/volume loop of a Forced
Vital Capacity test.
The majors information that you can get from this manoeuvres are the flow reserve
(flow distance from the peak flow of the F/V loop during exercise to the corresponding
flow on the superimposed F/V loop at rest) and the volume reserve (volume distance
from the maximum volume of the F/V loop during exercise to the corresponding
volume on the superimposed F/V loop at rest).
The manoeuvre consists in the following phases:
•
Acquiring some Flow/Volume loops during the exercise
•
Making the patient inspire completely up to TLC level (this is necessary to place
the loop correctly into the rest F\V loop of the forced Vital Capacity test)
•
Overlapping the F/V loop acquired during exercise and the F/V loop performed at
rest.
Flow Volume loop during the test
1.
2.
3.
Start with normal Exercise test and begin the memorisation of breath values (F2)
During a steady state select F/V loops form Test/Event...
As soon as 2 or 3 complete loops have been acquired ask the patient to inspire
completely up to TLC level and press F3 to stop the acquisition.
O2, CO2 vs Time
The O2, CO2 event is useful to check the real-time readings of the O2 and CO2 signals
during the test.
O2, CO2 vs Time during the test
1.
2.
3.
Start with normal Exercise test and begin the memorisation of breath values (F2)
During a steady state select O2, CO2 vs Time from Test/Event...
As soon as 5 or 6 complete breaths have been acquired press F3 to stop the
acquisition.
O2 Saturation (optional)
The O2 Saturation event is useful to check the quality of SpO2 signal acquired by the
on-board Oxymeter (if available) during the test.
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O2 Saturation during the test
1.
2.
3.
Start with normal Exercise test and begin the memorisation of breath values (F2).
Select O2 Saturation from Test/Event...
As soon as 5 or 6 complete pulses have been acquired press F3 to stop the
acquisition.
Spirogram
The spirogram event allows to display and store the volume/time plot.
Spirogram during the test
1.
2.
3.
Start with normal Exercise test and begin the memorisation of breath values (F2).
During a steady state select Spirogram form Test/Event...
Acquire volume/time plot until the window is filled and press F3 to stop the
acquisition.
View the events after the test
1.
2.
Select Data... from the View menu
Select the test during which spirogram event has been carried out in the list box and
press OK
3. Select View... from the Events menu, choose the desired event and press OK.
4. Select Print Current Window... from the File menu to print the F/V curve page.
It is possible to edit the F/V loops event in the following way:
5. Select Edit... from the Event menu to change the F/V loop at rest (the list contains
all the FVC test carried out by the same Patient with the Spirometry software) and
press OK.
Raw data
It's a particular feature with which the user can check and save some parameters (CO2
output, O2 concentration and volumes) in Ascii file format in a archive apart at a
sampling rate of 25 Hz.
Save Raw data
1.
2.
3.
4.
During the test choose Event from Events menu.
Select Raw Data from the list.
On the save data box give a name to the file and select the destination folder.
To stop saving Raw data press the stop icon or press F3 on the keyboard.
Chapter 13 - Exercise Testing - 123
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Resting Metabolic
Rate Test
Metabolism
Metabolism can be understood as the conversion by the human body between food and
accumulated fat into energy. The energy is used by the body to maintain constant
temperature , to move and to make all the organ function. Measure of metabolism is:
calories (cal).
Total Metabolic Rate
The total metabolic rate are the total calories that the human body needs in order to
actuate the daily functional activities.
Resting Metabolic Rate (RMR)
Resting Metabolic Rate represents the calories that the vital organs need to properly
operate at rest ( heart , brain , lungs , liver , kidneys etc.) . RMR represents between 60
% and 75 % of the human ‘s total metabolism.
Importance to measure RMR
A knowledge of the RMR is very helpful in order to understand the nutritional needs
and to properly manage it.
Measurement of the rest metabolic rate with indirect calorimetry
Energy expenditure can be measured directly by putting a person in a calorimeter and
measuring the amount of heat produced by the body mass.
This is expensive and very impractical in the clinical setting. Energy expenditure can be
measured indirectly with a metabolic cart by analysis of respired gases (usually expired)
to derive volume of air passing through the lungs, the amount of oxygen extracted from
it (i.e., oxygen uptake VO2) and the amount of carbon dioxide, as a by-product of
metabolism, expelled to atmosphere (CO2 output – VCO2). With these measurements
the resting energy expenditure (RMR) and respiratory quotient (RQ) can be calculated.
The RQ represents the ratio of carbon dioxide exhaled to the amount of oxygen
consumed by the individual. RQ is useful in interpreting the results of the RMR. The
abbreviated Weir equation is probably the most common calculation of RMR.
Abbreviated Weir equation:
RMR = [3.9 (VO2) + 1.1 (VCO2)] 1.44
How to perform a RMR test
For best results, when having a REE done, there are certain conditions that need to be
controlled and others that just require documenting at the time of the test. During the
test the individual is interfaced with a metabolic measurement system by means of a
facemask.
A mouthpiece with a nose clip is also sometimes used, but it may create overly stressful
conditions to a subject (patient).
Important considerations or conditions to improve the RMR measurement:
•
No food for at least 12 hours and no smoke for at least 2 hours before the test.
•
Maintain quiet surroundings when the test is in progress and normal temperature.
The individual should not move arms or legs during the test.
•
Medications taken should be noted, such as stimulants or depressants.
•
The first 5 minutes of acquisition should be discarded by the computation of RMR
•
Steady state should be achieved, which would be identified clinically by the
following criteria: 5 minute period when average minute VO2 and VCO2 changes
by less than 10%, average RQ changes by less than 5%
•
Stable interpretable measurements should be obtained in a 15 to 20 minute test.
•
Renal failure patients requiring hemodialysis should not be tested during dialysis
therapy.
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Recommendations
Resting metabolic rate test using the face mask
1.
2.
Since the ventilation is very low (normally <10 litres/min), the turbine calibration
has to be performed with very slow manoeuvres (each complete manoeuvre in
about 10-15 seconds), to obtain the best accuracy.
Use the following correction for the dead space (VD):
- 50 ml for the small mask
- 60 ml for the medium mask
- 70 ml for the large mask
Resting metabolic rate test using the canopy option
1.
2.
Verify, before and during the test, that the FeCO2 falls into the range 0.5%-0.8%
and adjust the flow rate of the pump. If the FeCO2 is too low, increase the flow, if it
is too high decrease the flow. In fact, if the FeCO2 is too low the measurement
could be not reliable, while an high FeCO2 could be dangerous for the patient.
In order to perform a correct ERGO calibration and to obtein more reliable data
from the test, it is recommended to use a calibration cylinder with the following
concectrations: 1% CO2, 20% O2, balance N2. If you use this cylinder, please
remember to modify the reference values, as explained in the chapter Calibration.
Chapter 14 - Resting Metabolic Rate Test - 127
Performing a test using the face mask
Calibrations
Before the test, it is necessary to perform an ergo calibration (see Calibration chapter)
and it is advisable to perform also a turbine calibration (see Recommendations in this
chapter).
How to prepare a patient
The patient interfaces with the equipment by means of a face mask, like in the stress
exercise. The mask has to be tight to the face, in order to avoid any air leakage.
Start the test
1.
2.
3.
Enter in the ergometry program
Select a patient or add a new one (File/Patients...)
Select Start test from Test menu
4.
5.
Enter the patient’s data and select the RMR mode (1st picture).
Press Other Data… and enter the dead space value (50ml Small mask, 60ml
Medium mask and 70ml Large mask). It is possible to enter the Ureic Nitrogen
value NU (2nd picture).
6. Confirm and start the test by pressing OK.
Selecting RMR the system set automatically the following options:
•
Data acquisition with a 30 seconds average
•
RMR protocol, which is:
- 5 minutes discarded;
- 10 minutes with data acquisition, of which the software will make an average at
the end of the test;
- automatic end of the test after the 16th minute.
• Selection of the RMR workspace (windows placement);
The test is fully automatic, the software will stop it and save the data at the end of the
16th minute.
The real time view is as shown in the following picture:
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Viewing the test
At the rend of the test, it will be opened automatically a window with the test results.
At the end of the test, or if it is selected View/RMR, the main results are shown:
Nota: The percentage of used
Proteins (PRO%) is calculated
assuming 12 grams of Ureic
Nitrogen in 24 hours. You can
modify this value selecting
View/Information… ->
Modify…
•
The average time interval (default: 10 minutes)
•
Average values of VO2, VCO2, R, RMR, RF, VE, HR, FAT% and CHO% and
predicted values if available.
•
Body Mass Index (BMI) and interpretation
•
Graph of the energetic expenditure for all the data acquisition interval, highlighting
the selected average interval.
In order to verify the goodness of the test, check that the ventilation and respiratory
frequency are similar to the predicted ones (12 breaths/min for the respiratory frequency
and 6 litres/min for the ventilation), and the heart rate is the rest heart rate of the patient.
Chapter 14 - Resting Metabolic Rate Test - 129
How to modify the average interval
If the average interval (automatically identified by the software) is not satisfying, for
example because the patient was speaking in the first minutes, it is possible to modify
the interval of the average.
Right-click and select Edit RMR…. It is possible to move the start and the end lines.
To move the start line, left-click on the exact time in which you want to start the
calculations, for the end line, right-click.
Print
The print of the current window generates a report similar to the one in the following
page.
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Chapter 14 - Resting Metabolic Rate Test - 131
Performing a test using the canopy option
The principle of a ventilated bubblehood system is that a stream of air is forced to pass
across the face of a subject and mixes with the air which is collected by a transparent
hood, placed over the subject’s head. A measurement system, knowing the flow rate,
calulates the oxygen consumption and the CO2 production and, starting from these
values, the energy expenditure.
Calibrations
Before the test, it is necessary to perform an ergo calibration (see Calibration chapter)
and it is advisable to perform also a turbine calibration (see Recommendations in this
chapter).
How to prepare the canopy and the patient
Replacement of the power plug
If the power plug does not fit into the mains socket, replace it with the one in the
packaging.
In order to replace the plug:
1. Extract the plug from the battery charger
2. Insert the proper plug in the battery charger.
Connecting the Canopy
1.
2.
Connect the Canopy unit to the mains by means of the medical grade AC/DC
adapter provided.
Insert the bubblehood adapter into the bubblehood from the outside and fix it
screwing the ring from the inside, being careful to insert it in the proper hole, as
shown in the following picture.
3.
4.
5.
Connect the bubblehood to the wrinkled tube, interposing a bacterial filter.
Connect the wrinkled tube to the unit through the Flow in connector.
Connect the optoelectronic reader of the Quark to the Flow out connector of the
Canopy unit through the spirometry adapter.
6.
Fix the vail to the bubblehood through the velcro strips.
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How to prepare the patient
1.
2.
3.
4.
Switch on the Canopy unit. If there are no problems, the red led on the front panel
of the unit flashes for few seconds and the alarm beeps. If the led does not flash
and/or the alarm does not beep, the test cannot be performed, because the backup
battery is exhausted or there is no backup battery.
When the green led turns on, the test can start. If the green led does not turn on, the
red led flashes and the alarm beeps, the test cannot be performed because the pump
does not work or the mains does not power the system.
After these checks, put the patient in a supine position.
Place the bubblehood with the vail on the patient’s head. The tube has to be placed
near the patient’s mouth.
Performing the test
1.
2.
3.
Enter in the ergometry program
Select a patient or add a new one (File/Patients...)
Select Start test from Test menu.
4.
5.
6.
Enter the patient’s data and select the Canopy mode.
Confirm and start the test by pressing OK.
In the first part of the test the flow rate of the pump has to be adjusted by means of
the Flow adjustment handle on the front panel of the Canopy unit, in order to
measure an FeCO2 between 0.5% and 0.8%. FeCO2 values can be read on the right
side of the PC monitor.
When the FeCO2 remains within the acceptability range, press F2 to start the data
acquisition. Verify, also during the test, that the measured FeCO2 is within the
0.5%-0.8% range. Otherwise, adjust it by means of the Flow adjustment handle.
7.
Warning: If the green led turns off during the test, the red led flashes and the alarm
beeps, abort the test, because the pump does not work or the mains does not power the
system. In the last case, the pump works only because of the backup battery.
The test is fully automatic, the software will stop it and save the data at the end.
Chapter 14 - Resting Metabolic Rate Test - 133
Viewing the test
At the end of the test, it will be opened automatically a window with the test results.
At the end of the test, or if it is selected View/RMR, the main results are shown:
Note: The percentage of used
Proteins (PRO%) is calculated
assuming 12 grams of Ureic
Nitrogen in 24 hours. You can
modify this value selecting
View/Information… ->
Modify…
•
The average time interval (default: 10 minutes)
•
Average values of VO2, VCO2, R, RMR, VE, HR, FAT% and CHO% and predicted
values if available.
•
Body Mass Index (BMI) and interpretation
•
Graph of the energetic expenditure for all the data acquisition interval, highlighting
the selected average interval.
In order to verify the goodness of the test, check that the FeO2 and FeCO2 values are
within the acceptability ranges (20.2%-20.8% and 0.5%-0.8% respectively), and the
heart rate is the rest heart rate of the patient.
How to modify the average interval
If the average interval (automatically identified by the software) is not satisfying, for
example because the patient was speaking in the first minutes, it is possible to modify
the interval of the average.
Right-click and select Edit RMR…. It is possible to move the start and the end lines.
To move the start line, left-click on the exact time in which you want to start the
calculations, for the end line, right-click.
Print
The print of the current window generates a report similar to the one of the RMR test
using the face mask.
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Sub-maximal
Exercise Testing
Introduction
Several physiological responses to exercise are used to evaluate cardiorespiratory
fitness, including oxygen consumption, heart rate, and blood pressure. Measuring these
variables during exercise, particularly maximum exercise, increase the chance of
detecting any coronary artery disease or pulmonary disease.
Unfortunately, maximum exercise tests are impractical because they are expensive,
require extensive clinical supervision, and subject individuals to levels of physical stress
that may be unnecessary depending on the objectives of the test. Consequently,
maximal testing is reserved for clinical assessments, athletic evaluation, and research.
A sub-maximal exercise test costs less and carries a lower risk for the individual.
Although less sensitive and specific for detecting disease or estimating maximal oxygen
consumption, correctly performed sub-maximal tests can provide a valid estimate of
cardiorespiratory fitness.
Pre-test screening
Pre-test health screening is essential for risk stratification and for determining the type
of test that should be performed and the need for an exercise test prior to exercise
training. A thorough pretest health screening includes the following:
•
Complete medical history
•
Medical contraindications to exercise
•
Symptoms suggesting cardiac or pulmonary disease
•
Angina or other forms of discomfort at rest or during exercise
•
Unusual shortness of breath at rest or during exercise
•
Dizziness or light-headedness
•
Orthopaedic complications that may prevent adequate effort or compromise the
validity of test results
•
Other unusual signs or symptoms that may preclude testing
•
Risk factors for coronary heart disease
•
History of major cardiorespiratory events
•
Current medications
•
Activity patterns
•
Nutritional habits
•
Reading and signing an informed consent form
136 - Quark PFT User Manual
Sub-maximal exercise testing
Heart rate varies linearly with VO2 to the point of maximum exertion; thus, VO2max may
be estimated using the relation between heart rate and VO2 without subjecting the
individual to maximum levels of physical stress. During sub-maximal exercise testing,
predetermined workloads are used to elicit a steady state of exertion (plateau of heart
rate and VO2). The steady-state heart rate at each work level is displayed graphically
and extrapolated to the VO2 at the age-predicted maximal heart rate (HR = 220-age). A
variety of protocols for different exercise modalities (i.e., treadmill, stationary cycle,
and step increments) can be used as long as the VO2 requirements of each selected
workload can be estimated with accuracy.
The objectives of cardiorespiratory fitness assessments in the apparently healthy
population are as follows:
•
Determine the level of cardiorespiratory fitness and establish fitness program goals
and objectives.
•
Develop a safe, effective exercise prescription for the improvement of
cardiorespiratory fitness.
•
Document improvements in cardiorespiratory fitness as a result of exercise training
or other interventions.
•
Motivate individuals to initiate an exercise program or comply with an established
program.
• Provide information concerning health status.
A few assumptions regarding testing are necessary to ensure the highest degree of
accuracy when using sub-maximal exercise testing to estimate VO2max:
•
Selected workloads are reproducible. A steady-state heart rate is obtained during
each stage of the test. Usually, workload durations of 3 minutes or more are used to
ensure steady state.
•
The maximal heart rate for a given age is uniform (HR = 220-age).
•
Heart rate and VO2 have a linear relation over a wide range of values; thus, the
slope of HR/VO2 regression can be extrapolated to an assumed maximum heart
rate.
• Mechanical efficiency (i.e., VO2 at a given work rate) is consistent.
Although if done correctly, sub-maximal exercise tests provide valuable information
concerning cardiorespiratory fitness, they have extremely limited diagnostic capabilities
and should not be used as a replacement for clinical exercise tests or other clinical
treatment or management modalities. Health care professionals should avoid detailed
interpretation beyond the scope of the information obtained.
Considerations with sub-maximal exercise testing
Considerations for selection of protocol and equipment include any physical or clinical
limitations that may preclude certain types of exercise (i.e., age, weight, arthritis,
orthopaedic complications, individual comfort, level of fitness, type of exercise training
that will be performed, and individual preference).
For example, some individuals may perform better on a non-weight-bearing modality
(cycle versus treadmill), while others may not have the required range of motion in the
hip or knee to pedal and may perform better walking. Deconditioned, weak, or elderly
persons may have to start the test at a low work level and increase the workload in small
increments. Also, field tests may not be appropriate for those who require strict
supervision during testing, who do not understand the concept of pacing, or who cannot
be expected to put forth a good effort. More consistent results may be obtained by
testing in a controlled environment such as a laboratory setting. Creativity when
selecting protocols may allow adaptations of commonly used protocols to accommodate
athletes competing in specific sports. Regardless of the type of exercise and protocol
selected, the same type of exercise and protocol should be used for repeat testing if
between-test comparisons are important.
Chapter 15 - Sub-maximal Exercise Testing - 137
Staffing
Staff members should be able to do the following:
1. Establish rapport with the subject and make him or her feel comfortable.
2. Recognize normal acute and chronic responses to exercise.
3. Recognize abnormal signs and symptoms during exercise.
4. Provide basic life support measures competently.
5. Adhere to established procedures and protocols.
6. Clearly explain test results to the individual.
Test termination
Sub-maximal tests should be terminated according to ACSM or other accepted
guidelines (see table in the following). In the event of an abnormal response, the test
should be terminated, the medical director of the facility and the individual’s primary
care physician notified, and all specified follow-up procedures performed. In the event
of mechanical or electrical failure that may compromise the accuracy of the test results
or monitoring capabilities, the test should be terminated until the problem is corrected.
General Indications for Stopping an Exercise Test in Apparently Healthy Adults
Onset of angina or angina-like symptoms
Significant drop (20 mmHg) in systolic blood pressure or a failure of the systolic blood
pressure to rise with an increase in exercise intensity
Excessive rise in blood pressure: systolic pressure >260 mmHg or diastolic pressure
>115 mmHg
Signs of poor perfusion: tight-headedness, confusion, ataxia, pallor, cyanosis, nausea, or
cold and clammy skin
Failure of heart rate to increase with increased exercise intensity
Noticeable change in heart rhythm
Subject requests to stop
Physical or verbal manifestations of severe fatigue
Failure of the testing equipment
Assuming that testing is non-diagnostic and is being performed without direct physician
involvement or electrocardiographic monitoring.
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Considerations for accuracy
The ability to obtain valid and reproducible results is essential to ensure that any
differences between pre-treatment and post-treatment test results are due to exercise
training rather than variations in testing procedures. Some inconsistencies that are
inherent may increase variability:
•
Sub-maximal heart rate is influenced by time of day, eating, smoking, and
familiarization with test procedures.
•
Prediction equations for estimating VO2max may overestimate trained individuals
and underestimate untrained individuals.
•
The efficiency of motion during walking, running, and cycling varies.
• Cardiac output and VO2 have a test-retest variability of 3-4%.
Psychological factors, such as pre-test anxiety, may influence the heart rate, especially
at rates below 120 beats per minute and at low workloads. It is not unusual for the heart
rate and/or blood pressure to be higher at rest than during the initial stages of exercise in
these cases. Having the subject repeat the first test may improve reliability, particularly
if the subject has never previously performed such a test.
Factors that can cause variation in the heart rate response to testing:
•
Dehydration
•
Prolonged heavy exercise prior to testing
•
Environmental conditions (e.g., heat, humidity, ventilation)
•
Fever
• Use of alcohol, tobacco, or caffeine 2 to 3 hours prior to testing
Because of these inherent inconsistencies, standard procedures for each test must be
strictly followed to ensure the greatest accuracy and reproducibility possible:
•
Standard testing protocol
•
The same testing modality and protocol for repeat testing
•
A constant pedal speed throughout cycle ergometry testing
•
Cycle seat height properly adjusted, recorded, and standard for each test
•
The time of day for repeat testing consistent
•
All data collection procedures standardized and consistent
•
Test conditions standard
•
Subjects free of infection and in normal sinus rhythm
•
Prior to the test, no intense or prolonged exercise for 24 hours, smoking for 2-3
hours, caffeine for 3 hours, or heavy meal for 3 hours
•
Room temperature 18-20°C (64-68°F) with air movement provided
Chapter 15 - Sub-maximal Exercise Testing - 139
Performing the test
In this chapter it is supposed that the user is able to:
•
perform an exercise test
•
create exercise protocols
• view, edit and print tests
If this is not the case, please read the Exercise testing chapter.
To perform a sub-maximal test, follow these instructions:
1. Create a proper protocol (procedural guidelines for several sub-maximal testing
protocols are provided in [ACSM’s Guidelines for Exercise Testing and
Prescription, 6th Edition Philadelphia: Williams&Wilkins, 2000:22-29]).
2. Start an exercise test.
3. Perform the test as it were a maximal exercise test, ending it when the heart rate
reaches the 85% of the Hrmax, or it happens an event listed in the section Test
termination.
4. Display a VO2/Kg vs. HR plot
5. Right-click on the graph and select VO2 submax from the pop-up menu.
If the predicted HR max (calculated as 220-age) is not suitable for the patient tested, it
is possible to edit the HR max value from the View/Information… page.
An example of testing protocol
An example of protocol is reported here. The
defined as follows.
1st step: workload 150 kgm/min
2nd step: if the HR at the end of the 1st step is:
set the workload at (kgm/min)
rd
3 step: if the HR at the end of the 2nd step is:
set the workload at (kgm/min)
4th step: if the HR at the end of the 3rd step is:
set the workload at (kgm/min)
140 - Quark PFT User Manual
YMCA cycle ergometry protocol is
<80
750
<80
900
<80
1050
80-89
600
80-89
750
80-89
900
90-100
450
90-100
600
90-100
750
>100
300
>100
450
>100
600
System
maintenance
System maintenance
All service operations which are not specified in this user manual should be performed
by qualified personnel in accordance with the service handbook (to be required to the
manufacturer).
Rubber mouthpieces, face masks, breathing valve and the other parts are not shipped
sterile. They should be disinfected before using according to the following instructions.
All materials used in the construction of the Quark PFT are non toxic and pose no safety
risk to the patient or operator.
Prior to the device cleaning, disinfection and inspection it is necessary to switch off the
device and to disconnect adapters from the supply mains.
In order to guarantee the highest accuracy of measurements we recommend you to
disinfect the turbine periodically.
Use disposable anti-bacterial filters or disinfect each part in contact with the patient
before each test.
Cleaning and disinfection
Cleaning and disinfecting instructions are of fundamental importance to control
infections and assure patient safety. In fact aspiration of residue, particles and
contaminated agents are life – threatening.
In this handbook we strongly recommend you to follow the rules worked out by ATS
and ERS (see: ”Lung Volume Equipment and Infection Control” – ERS/ATS
WORKSHOP REPORT SERIES, European Respiratory Journal 1997; 10: 1928 –
1932), which are summarised as follows:
•
Accessible internal as well as external surfaces of equipment exposed to expired
gas should be washed and disinfected prior to testing of subsequent patients.
•
Liquid disinfection can be used if the equipment is well cleaned first (no droplets of
saliva/sputum remain).
•
Disposable gloves should be worn when handling mouthpieces, when cleaning
equipment exposed to saliva or sputum and especially when drawing blood.
•
Laboratory staff should wash hands prior to testing of each patient.
•
Adopt particular precautions when testing patients with recognised high – risk
communicable diseases (e.g. tuberculosis, multidrug – resistant staphylococcus). In
these cases, the clinical need for such testing should justify the risks.
During the disinfection:
•
do not use alcohol or other liquids containing gluteraldehyde on the exterior
surfaces of the equipment. Actually they can damage polycarbonates plastics and
may produce unhealthy substances.
•
do not use abrasive powders or glass cleaners containing alcohol or ammonia on the
plexiglas components of the equipment
•
do not steam autoclave any parts of the equipment unless it is clearly specified.
•
do not immerse the optoelectronic reader.
Preparing the disinfecting solution
The following recommendations are retrieved from:
APIC (Association for Professionals in Infection Control and Epidemiology, Inc.):
APIC Guidelines for Selection and Use of Disinfectants; William A. Rutala, PhD, MPH,
CIC. American Journal of Infection Control, vol.24, N.4, pp. 313-342, August 1996 http://www.apic.org/pdf/gddisinf.pdf
As disinfecting solution it is suggested:
•
Sodium hypochlorite 0.5% (5000 ppm) prepared fresh for use within 24 hours.
• Sodium hypochlorite 1% (10000 ppm) prepared fresh for use within 30 days.
The first solution can be easily prepared by adding 1 part household bleach (sodium
hypochlorite 5.25%) to 9 parts water, the second one by adding 1 part household bleach
to 4 parts water.
142 - Quark PFT User Manual
Cleaning the turbine flowmeter
Warning: Do not use
alcoholic solutions for the
turbine, otherwise there can
be damages to the plastic
material.
It is necessary to disinfect periodically the turbine for sanitary measures or/and for the
correct device function.
The disinfecting procedure is easy and may be effected every time the user needs,
keeping attention to some precautions:
1. Take out the turbine.
2. Dip it in a disinfectant solution (non alcoholic based) for about 20 minutes.
3. Rinse the turbine in a vessel, filled of clean water, shaking gently to remove the
disinfectant (do not clean the turbine by putting it under running water!).
4. Let it dry to air.
5. After cleaning the turbine, check if the turbine propeller rotates freely even with a
low speed air flow.
6. Connect the turbine to the reader.
Precautions during the cleaning of the turbine
1.
2.
3.
Do not expose the turbine to high heat and do not put it under running water.
Do not ever dip the optoelectronic reader in any kind of solution, the liquid
infiltration would damage the internal circuit.
Do not use alcoholic solutions to clean the turbine.
Suggested disinfection solutions
Helipur H Plus
Gigasept FF
Dismozon pur
TETA-S
CIDEX
Braun Melsungen AG
Schulke & Mayr GmbH
Bode Chemie GmbH
Fresenius AG
Johnson & Johnson
Cleaning the Breathing valve
The breathing valve should be cleaned everyday or at least every 10-15 tests.
Chapter 16 - System maintenance - 143
1.
2.
3.
4.
5.
6.
Remove the flowmeter from the breathing valve
Remove the demand valve from the breathing valve
Remove the valve body from the hand holder
Remove the membrane valve
Close the valve body with the cleaning protection plate
Dip all parts in the cleaning solution and re-assemble everything after the
disinfection.
Masks cleaning and disinfection
The face masks should be cleaned and sterilised after each test.
Disassembling the different parts of the mask
1.
2.
Remove the valves from their place.
Remove the adapter for the optoelectronic reader.
Cleaning the mask
1.
2.
Clean the mask with hot water and a soap solution to remove the impurities.
Rinse the mask with energy in running hot water.
Warning: Do not use synthetic or petroleum-based products for the masks cleaning.
Disinfecting the mask
It’s possible disinfecting the mask following these procedures:
•
144 - Quark PFT User Manual
Standard autoclaving method
Rapid cycles of autoclave lasting 10 minutes at 132°C (270°F)
Heavy cycles of autoclave lasting 30 minutes at 121°C (250°F)
Pre vacuum cycles of autoclave lasting 30 minutes at 121°C (250°F)
•
Hetilene oxide method (ETO)
The hetilene oxide doesn’t deteriorate the face masks. Sterilisation by this method
is not advised unless sufficient data is available regarding the time required for
complete out-gassing of residual ETO. If you use this method, follow carefully the
instruction provided by the maker of the sterilising product.
•
Pasteurisation
The disinfecting with hot water is a sterilising method that may be used with the
silicone masks.
Permapure maintenance
•
Do not bend, squash or deform it.
•
Do not keep it in open air, if not used, especially in crowded or smoky places.
•
If saliva is entered in the tube, replace it immediately, because it lost its functions.
•
Periodically grease the o-ring on the connector in order to simplify the flowmeter
connection.
•
Replace it every 100 test / 6 month.
Inspections
The equipment requires easy inspections to be carried out in order to assure a proper
electrical and mechanical safety level in the years.
These inspections are highly recommended after a rough use of the equipment or after a
period of storage in unfavourable environmental conditions.
Referring to the electrical safety, it is important to check the conditions of insulation
materials of cables, plugs and any other visible part by means of simple inspection,
when the equipment is switched off and adapters (or electrical feeders) are disconnected
from the supply mains.
Mechanical parts to check are: the turbine and breathing circuits.
Follow these instructions:
•
extract the turbine from the optoelectronic reader;
•
verify, by inspection, that the turbine axis fits correctly its seats and the blade is
strongly fastened on the axis itself (it can be useful to shake slightly the turbine in
order to note any anomalous movement).
Check if there are any torn or broken components in the breathing circuits: remember
that they can create safety risk to patients during tests.
Replace the fuses
The fuses can be replaced easily in the following way:
1. Open the power supply cover using a screwdriver as shown in the picture.
2.
Extract the fuse holder as shown in the picture
Chapter 16 - System maintenance - 145
3.
Replace the damaged fuse(s).
Note: Be careful to use proper fuses:
A 680 013 630 (Time Lag Fuses 5x20 250V T 630 mA) for 220/240V supply
A 680 024 125 (Time Lag Fuses 5x20 250V T 1,25A) for 100/120V supply
Select the proper power supply voltage
The power supply voltage can be changed in the following way:
1. Open the power supply cover using a screwdriver.
2. Rotate the voltage selector in order to read the desired value.
146 - Quark PFT User Manual
Appendix
Service - Warranty
Warranty and limitation of liability
COSMED provides a one (1) year limited warranty from the date of the original sale of
COSMED products. All COSMED products are guaranteed to be free from defect upon
shipment. COSMED’s liability for products covered by this warranty is limited
exclusively to replacement, repair, or issuance of a credit for the cost of a defective
product, at the sole discretion of COSMED. COSMED shall not be liable under the
foregoing warranty unless (i) COSMED is promptly notified in writing by Buyer upon
discovery of defect; (ii) the defective product is returned to COSMED, transportation
charges prepaid by Buyer, (iii) the defective product is received by COSMED no later
than four weeks after the last day of the one (1) year limited warranty period; and
(iv) COSMED’s examination of the defective product establishes, to COSMED’s
exclusive satisfaction, that such defect was not caused by misuse, neglect, improper
installation, unauthorised repair or alteration, or accident.
If the product is
manufactured by a third-party, COSMED shall make available for the Buyer’s benefit
only those warranties which COSMED has received from the third-party
manufacturer(s). COSMED hereby specifically disclaims any and all warranties and/or
liabilities arising from defect(s) and/or damage(s) to and/or caused by products
manufactured by third-party manufacturers. Buyer must obtain written authorisation
from COSMED prior to the repair or alteration of COSMED products(s). Failure of
Buyer to obtain such written authorisation shall void this warranty.
COSMED hereby specifically disclaims any and all other warranties of any kind,
whether express or implied, in fact or by law, including, but without limitation, any and
all warranties of merchantability and/or fitness for a particular purpose.
COSMED shall not be liable for special, indirect and/or consequential damages, nor for
damages of any kind arising from the use of any COSMED’s products, whether said
products are used alone or in combination with other products or substances.
Determination of the suitability of any of COSMED’s product(s) furnished hereunder
for the use contemplated by Buyer is the sole risk and responsibility of Buyer, and
COSMED has no responsibility in connection therewith. Buyer assumes all risks and
liabilities for loss, damage or injury to persons or property of Buyer or others arising out
of the use or possession of COSMED’s products.
The limited warranty as herein above set forth shall not be enlarged, diminished,
modified or affected by, and no obligation or liability shall arise or grow out of, the
renderings of technical advice or service by COSMED, its agents or employees in
connection with Buyer’s order or use of the product(s) furnished hereunder.
Return goods policy for warranty or non warranty repair
Goods shipped to COSMED for repair are subject to the following conditions:
1. Goods may only be returned after your receipt of a Service Return Number
(SRN) from COSMED S.r.l.
2. Place your SRN report and Packing List outside the package.
3. Goods returned must be shipped with freight and insurance charges prepaid.
Collect shipments will not be accepted.
4. The following list of goods are not eligible for return unless proven defective.
- Special order items
- Expendable products
- Goods held over 30 days from COSMED’s invoice date.
- Used goods not in original shipping containers.
- Goods which have been altered or abused in any way.
5. The following parts are not covered by warranty:
- consumables
- fragile glass or plastic parts
- rechargeable batteries
- damages at the
- damages due to use of the device not conforming to the indication reported in this
manual
148 - Quark PFT User Manual
Repair Service Policy
Goods returned to seller for Non-Warranty repair will be subject to conditions 1, 2, 3, 4.
The returned goods need to re-enter COSMED together with the customs documents
(Pro-forma Invoice and Customs Paper) as requested by the Italian law.
•
The shipment has to be qualified as a Temporary Export.
•
All the goods returned to COSMED without the customs papers will not be
accepted.
For European Community members:
Pro-Forma invoice complete with:
•
Number
•
Description of the goods
•
Quantity
•
Serial Number
•
Value in €
•
Number of parcel
•
Gross weight
•
Net weight
• Reason for resent (i.e. Resent for repair)
In case you should send the system for repair please contact the nearest service centre or
contact COSMED at the following address:
COSMED S.r.l.
Via dei Piani di Monte Savello 37
P.O. Box 3
00040 Pavona di Albano - Rome, Italy
tel.
+39 (06) 9315492
fax
+39 (06) 9314580
E-mail: [email protected]
For USA customers only please contact:
COSMED USA Inc
2758 North Paulina
Chicago IL 60614 USA
Phone:+1 (773) 528-8113
Fax: +1 (773) 528-8116
email: [email protected]
To ensure that you receive efficient technical assistance, please specify as precisely as
possible the nature of the problem as it is specified on the assistance information form.
We advise you to save the original packaging. You may need it in case to ship the unit
to a technical assistance centre.
Chapter 17 - Appendix - 149
Privacy Information
Dear Customer,
we inform you that your personal data are gathered and will be used by Cosmed Srl in
conformity with the requirements of the Italian privacy law (Decreto Legislativo
196/2003). We believe it is important for you to know how we treat your personal data.
Personal data treatment and purposes
We request and process your personal data:
a. to place an order, register a product, request a service, answer a survey, enter a
contest, correspond with us (all of the above, in the following: “service”) and, if
necessary, to supply the Competent Authorities with the required information;
b. in order to define your commercial profile;
c. in order to use your commercial profile for own marketing and advertising
purposes;
d. for accounting purposes, including e-mailing of commercial invoices;
e. for providing your information to selected business partners (also abroad), in order
to supply the service;
How your personal data are treated
Your personal data will be stored in electronic format, and protected at the best from
destruction, loss (even accidental), not authorized accesses, not allowed treatment or use
not in conformity with the purposes above listed.
The consent is optional, but…
If you deny the consent, we regret we cannot supply the service.
Holder of the treatment
The holder of the treatment is Cosmed Srl, Via dei Piani di Monte Savello 37, Pavona di
Albano Laziale (RM). The responsible of the personal data treatment is indicated in the
documentation stored by Cosmed Srl itself.
Customer rights
In accordance with art.7 of the Law, you can:
a. obtain confirmation of the existence of your personal data and their communication
in intelligible form;
b. obtain:
• updating, correction or integration of your data;
• deletion or transformation in anonymous form of your personal data;
c. deny your consent to the treatment of your personal data;
These rights can be exercised directly requesting in writing to the holder of the
treatment.
150 - Quark PFT User Manual
Heart Rate – TTL input
The Heart Rate TTL input allows to measure the hearth rate signal from any ECG with
a pulse signal (0-5 Volts) available or from the POLAR belt receiver probe.
Referring to the connector labelled as HEART RATE on the rear panel of the Quark
PFT, the pin out assignment is the following:
pin
Signal
5
4
TTL input
GND
Chapter 17 - Appendix - 151
Converting factors configuration
You can edit the parameters shown in Control Panel by selecting Control Panel from
the Calibration menu in the calibration program, then pressing the button by side.
You might configure the following options:
Name:
identify the parameter
Unit of meas.:
unit of measurement
Base line and Gain: factors used to convert the acquired raw data (mV) into the final
format according to Y=(mV-BL)*Gain. The value entered for
gain must be multiplied by 1000 (for Gain=1, enter 1000).
Precision:
the number of decimals shown as 0
152 - Quark PFT User Manual
Calculations references
VO2 and VCO2
"Energy Expenditure and Fuel Selection in Biological Systems: The Theory and
Practice of Calculations Based on Indirect Calorimetry and Tracer Methods": M. Elia,
G. Livesey, World Rev. Nutr. Diet. Basel, Karger, 1992, vol 70, pp 68-131.
"Nutritional Assessment in Critical Care, A Training Handbook": Donald C. Zavala
Anaerobic threshold (modified V-Slope)
The break-point or intercept of the two slopes can be selected by a computer program
that defines the VO2 above which VCO2 increases faster than VO2, without
hyperventilation.
During an incremental exercise above the Lactate Threshold, the net increase in lactic
acid production results in an acceleration of the rate of increase in VCO2 relative to
VO2. When these variables are plotted against each other (squared graph without
recovery points), the relationship is composed of two apparently linear components, the
lower of which has a slope of slightly less than 1.0, whereas the upper component has a
slope steeper than 1.0. The intercept of these two slopes is the LT or AT point measured
by gas exchange.
The increase in VCO2 in excess of that derived from aerobic metabolism must be
generated from the buffering of lactic acid. This is an obligatory gas exchange
phenomenon seen in all subjects who exercise to work levels above their LT. This
technique is referred to as the V-Slope method.
References
OVS, Original V-Slope method: "A new method for detecting anaerobic threshold by
gas exchange", Beaver, Wasswrman, Whipp, JAP 1986, 60:2020-2027.
MVS, Modified V-Slope method: "Metabolic acidosis during exercise in patients with
chronic obstructive pulmonary disease", Sue, Wasserman, CHEST 1988, 94:931-938.
O2 kinetics
“Delayed Kinetics of VO2 in the Transition from prior Exercise. Evidence for O2
Transport Limitation of VO2 Kinetics: A Review”; R.L. Hughson and M.A. Morrissey,
Int. J. Sports Med. 4 (1983) 31-39
ISO 8996: Ergonomics – Determination of metabolic heat production, 1990
In the following picture it is shown how the O2 debit and deficit values are computed.
Chapter 17 - Appendix - 153
ATS 94 recommendations
Reference: “Standardization of Spirometry: 1994 Update” “American J. Respiratory
Critical Care Medicine”, Vol. 152, 1107-1136; 1995.
ATS recommendations
Volume range:
8l (BTPS)
Flow range:
±14 l/sec
Volume accuracy:
±3% or < 50ml
Flow accuracy:
±5% or < 200ml/sec
Flowmeter resistance: <1.5 cmH2O da 0 a 14 l/sec
Reproducibility: the 2 largest of 3 acceptable FEV1 and FVC values should be within
5% or 150 ml.
The end of test: no change in volume for 1 second with at least 6 seconds of collected
volume.
Accumulation time: the maximum time allowed for volume accumulation during the
VC manoeuvre should be at least 30 seconds and at least 15 seconds during the FVC.
The spirometer should be store at least 8 FVC maneuvres.
FEV1 should be calculated by using the “back extrapolation” method to detect the start
of the test, extrapolated volume must not be higher then 5% FVC or 150ml.
The graphic resolution of the printed report must be as in the following:
Volume:
10 mm/l
Flow:
5 mm/l/sec
Time:
20 mm/sec
F/V ratio:
2:1
The total number of error (FVC e FEV1 >±3.5%, FEF25-75% >5.5%) during the
measurement of the 24 standard waveforms must be lower than 4.
154 - Quark PFT User Manual
Predicted values
ERS93
Standardized Lung Function Testing: Official Statement of the European Respiratory
Society, The European Respiratory Journal Volume 6, Supplement 16, March 1993.
Compilation of reference values for lung function measurements in children: Ph. H.
Quanjer, J. Stocks, G.Polgar, M. Wise, J. Karlberg, G. Borsboom; ERJ 1989, 2,
Supp.4,184s-261s.
KNUDSON 83
Changes in the Normal Maximal Expiratory Flow-Volume Curve with Growth and
Anging: J. Knudson, D. Lebowitz, J. Holdberg, B. Burrows; ARRD 1983; 127:725-734
ITS
Intermountain Thoracic Society: Clinical Pulmonary Function Testing, second edition
(1984) pp 101, 144
LAM
A survey of ventilatory capacity in Chinese subjects in Hong Kong: Lam Kwok-Kwong,
Pang Shing et Al. Annals of Human Biology, 1982, vol. 9, No. 5, 459-472.
Multicéntrico de Barcelona
Spirometric reference values from a Mediterranean population: J. Roca, J. Sanchis, A.
Agusti-Vidal, F. Segarra, D. Navajas. R. Rodriguez-Roisin, P. Casan, S. Sans. Bull. Eur.
Physiopathol. Respir. 1986, 22, 217-224.
Nhanes III
Spirometric reference values from a sample of the general US population: John L.
Hankinson, John. R. Odencrantz and Kathleen B. Fedan. Am J Respir Critr Care Med
1999, 159, 1798-187.
Pneumobil (Brazil)
Valores extraìdos do Programa Pneumobil/Brasil para a Tese de Doutoramento do Dr.
Carlos Alberto de Castro Pereira. (Boehringer).
Gutierrez (Chile)
Gutierrez et Al. Reference values for Chile population
Knudson, Morris and Bass
The maximal Expiratory Flow-Volume curve: Knudson et al. ARRD Vol. 123, p. 659664, 1981
Spirometric Standard for healthy non-smoking adults: ARRD Vol. 10-3, p. 57-67, 1971
Pereira (Brazil)
Pereira CAC; Barreto SP; Simões JG; Pereira FWL; Gerstler JG; Nakatani J. Valores de
Referência para Espirometria em uma amostra da população brasileira adulta. Jornal de
Pneumologia 1992; 18: 10-22.
Mallozi MC. Valores de referência para espirometria em crianças e adolescentes,
calculados a partir de uma amostra da cidade de São Paulo. Valores finais publicados
em : Pereira CAC; Lemle A; Algranti E; Jansen JM; Valença LM; Nery LE; Mallozi
M; Gerbasi M; Dias RM; Zim W. I Consenso Brasileiro sobre Espirometria. Jornal de
Pneumologia 1996; 22:105-164.
Scalambrini Costa F, Scueiri CEB, Silva Jr WC, Pereira CAC, Nakatani J. Valores de
referência para espirometria em uma amostra da população brasileira adulta da raça
negra. J Pneumologia 1996;22: 165-170.
Neder JA; Andreoni S; Castelo-Filho A; Nery LE. Reference values for lung function
tests. I. Static Volumes. Brazilian Journal Medical and Biological Research 1999;
32:703-17.
Neder JA, Andreoni S, Lerario MC, Nery LE. Reference values for lung function tests.
II. Maximal respiratory pressures and voluntary ventilation. Braz J Med Biol Res 1999
;32:719-27
DLCO
Standardized Lung Function Testing: Official Statement of the European Respiratory
Society, The European Respiratory Journal Volume 6, Supplement 16, March 1993.
Chapter 17 - Appendix - 155
Compilation of reference values for lung function measurements in children: Ph. H.
Quanjer, J. Stocks, G.Polgar, M. Wise, J. Karlberg, G. Borsboom; ERJ 1989, 2,
Supp.4,184s-261s.
Reference Values for Residual Volume, Functional Residual Capacity and Total Lung
Capacity - ATS workshop on Lung Volume measurements, official statement of the
European Respiratory Society; J. Stocks, Ph. H. Quanjer: ERJ, 1995, 8, 492-506
Single Breath Oxygen Test
Buist SA, Ross BB: Quantitative Analysis of the Alveolar Plateau in the Diagnosis of
Early Airway Obstruction. ARRD 108: 1081, 1973
Mansell A, Bryan C, Levison H: Airway Closure in Children. JAP 33: 711-714, 1972
Buist SA, Ross BB: Predicted Values for Closing Volumes Using a Modified Single
Breath Test. ARRD 107: 744-751, 1973.
Rint
Lombardi E, Sly PD, Concutelli G, et al. Reference values of interrupter respiratory
resistance in healthy preschool white children. Thorax 2001; 56: 691-695.
Mip/Mep
Leo F. Black, Robert E. Hyatt: Maximal Respiratory Pressures: Normal Values and
Relationship to Age and Sex, American Review of Respiratory Disease, Volume 99,
1969
Vincken W, Ghezzo H & Cosio MG (1987). Maximal static respiratory pressures in
adults: normal values and their relationship to determinants of respiratory function. Bull
Eur Physiopathol Resp 23: 435-439.
Automatic diagnosis (algorithm)
Reference: “Lung Function Testing: selection of reference values and interpretative
strategies”, A.R.R.D., 144/ 1991:1202-1218.
LLN=Pred-0.674*SD (ATS, 50° percentile)
LLN=Pred-1.647*SD (ERS, 95° percentile)
LLN=Pred*0.8
(80%Pred)
Message interpretation
Criterion
Normal Spirometry
Obstructive abnormality (it may be physiological)
Obstructive abnormality: mild
Obstructive abnormality: moderate
Obstructive abnormality: moderately severe
Obstructive abnormality: severe
Obstructive abnormality: very severe
Restrictive abnormality: mild
Restrictive abnormality: moderate
Restrictive abnormality: moderately severe
Restrictive abnormality: severe
Restrictive abnormality: very severe
FVC and FEV1/FVC > LLN
% Pred FEV1 >= 100
% Pred FEV1 < 100 and >= 70
% Pred FEV1 < 70 and >= 60
% Pred FEV1 < 60 and >= 50
% Pred FEV1 < 50 and >= 34
% Pred FEV1 < 34
FVC < LLN and % Pred FVC >= 70
% Pred FVC < 70 and >= 60
% Pred FVC < 60 and >= 50
% Pred FVC < 50 and >= 34
% Pred FVC < 34
Quality Control Messages
Reference: Spirometry in the Lung Health Study: Methods and Quality Control, ARRD
1991; 143:1215-1223.
Message
Criterion
Start faster
Blast out harder
Avoid coughing
Blow out longer
VEXT >5% of the FVC and >150ml
PEFT >120 msec
50% drop in the flow in first second
FET100% <6 sec.
156 - Quark PFT User Manual
Blow out more air
Blow out harder
Take a deeper breath
Blow out faster
That was a good test
FVC reproducible
FEV1 reproducible
PEF reproducible
MVV time too short
flow >0.2l/s within 20 ml of FVC
dPEF<10%
dFVC<200ml and 5% best FVC
dFEV1<200ml and 5% FEV1
No errors
diff. 2 max FVC within 0.2 l
diff. 2 max FEV1 within 0.2 l
diff. 2 max PEF within 10 %
MVV time less than 12 sec
Chapter 17 - Appendix - 157
References
Spirometry
ATS ’94: “Standardization of Spirometry: 1994 Update”, American J. Respiratory
Critical Care Medicine, Vol. 152, 1107-1136; 1995
ERS ’93: “Standardized Lung Function Testing: Official Statement of the European
Respiratory Society”, The European Respiratory Journal Volume 6, Supplement 16,
March ”
Lung function", J.E. Cotes, Blackwell scientific publications
"Guidelines for Clinical Exercises Testing Laboratories", I.L. Pina, G.J. Balady, P.
Hanson, A.J. Labovitz, D.W. Madonna, J. Myers. American Heart Association. 1995;
91, 912.
Lung Volumes
ERS/ATS workshop report series: Multiple-breath nitrogen washout techniques:
including measurements with patients on ventilators; C.J.L. Newth, P. Enright, R.L.
Johnson; ERJ 1997; 10: 2174-2185.
Single-Breath with Apnea
ATS ’95: “ Single-breath Carbon Monoxide Diffusing Capacity (Transfer Factor),
Recommendation for a Standard Technique-1995 Update: Am. J. Respir. Crit. Care
Med. Vol 152, Vol 6 pp 2185-2198, 1995
ERS ’93: “Standardized Lung Function Testing: Official Statement of the European
Respiratory Society”, The European Respiratory Journal Volume 6, Supplement 16,
March 1993 – Standardization of measurement of transfer factor (diffusing capacity).
Single-Breath without Apnea
“Rest and Exercise Cardiac Output and Diffusing Capacity Assessed By a Single Slow
Exhalation of Methane, Acetylene, and Carbon Monoxide”: Ramage, Coleman and
MacIntyre, CHEST 92, 1, July 1987
Resistances
P. J. Chowienczyk, C. P. Lawson, S. Iane, R. Johnson, N. Wilson, M. Silverman, G. M.
Cochrane: “A flow interruption device for measurement of airway resistance”,
European Respiratory Journal, 1991, 4, 623-626
G. Liistro, D. Stanescu, D. Rodenstein, C. Veriter: “Reassesment of interrupter,
tecnique for measuring flow resistance in human”, J. Appl. Physiol., 67(3), 933-937,
1989.
Gas Exchange References
[“On line computer analysis and breath by breath graphical display of exercise function
tests.”; Beaver, Wasserman, Whipp, JAP , 34(1):128-132, 1973]
[“Measurement and analysis of gas exchange during exercise using a programmable
calculator”; Sue, Hansen, Blais, Wasserman, JAP, 49(3), 1980:456-461]
[“Principles of exercise testing and interpretation, 2° edition”; Wasserman et Al, 1994]
[“Clinical Exercise Testing, 3rd edition”, Jones 1988]
ERS task force on standardization of clinical exercise testing. “Clinical exercise testing
with reference to lung disease: indications, standardization and interpretation
strategies.” J. Roca, B. Whipp, S. Anderson, R. Casaburi, J.E. Cotes, P. Palange…., ERJ
1997; 10: 2662-2689.
Indirect calorimetry
[“Energy Expenditure and Fuel Selection in Biological Systems: The Theory and
Practice of Calculations Based on Indirect Calorimetry and Tracer Methods”: M. Elia,
G. Livesey, World Rev. Nutr. Diet. Basel, Karger, 1992, vol 70, pp 68-131.]
[“Nutritional Assessment in Critical Care, A Training Handbook”: Donald C. Zavala]
158 - Quark PFT User Manual
Sub-maximal testing
[“Cardiorespiratory Assessment of Apparently Healthy Populations”, Timothy R.
McConnell, in ACSM’s Resource Manual for Guidelines for Exercise Testing and
Prescription, 4th Edition, pp. 361-366]
[Franklin BA, ed. ACSM’s Guidelines for Exercise Testing and Prescription, 6th Edition
Philadelphia: Williams&Wilkins, 2000:22-29]
Chapter 17 - Appendix - 159
160 - Quark PFT User Manual