quark_b2_user_manual_xviii_edition.pdf
Page 1
COSMED does not assume any liability for end user interpretation of this user manual 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 expressed written
permission of COSMED Srl.
Each copy of the COSMED Software can only be installed on one computer.
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 b2 User manual, XVIII Edition
05/2008
Copyright © 1999 COSMED
Copyright © 2003 COSMED
COSMED Srl - Italy
http://www.cosmed.it
Part N. C00827-02-91
Page 2
Table of contents
Getting started
12
Important notices ............................................................................ 13
Intended use ............................................................................. 13
Warnings .................................................................................. 13
Contraindication ............................................................................. 15
Contraindications for the Spirometer tests ............................... 15
Absolute contraindications............................................. 15
Relative contraindications.............................................. 15
Contraindications for Bronchial provocation tests ................... 15
Absolute contraindications............................................. 15
Relative contraindications.............................................. 15
Contraindications for Exercise testing ..................................... 15
Environmental condition of use ...................................................... 16
EMC ................................................................................................. 17
Safety and conformity ..................................................................... 20
Safety ............................................................................. 20
EMC ............................................................................... 20
Quality Assurance .......................................................... 20
Medical Device Directive (CE mark) ............................ 20
Keynotes ......................................................................................... 21
Typographic keynotes .............................................................. 21
Graphic keynotes...................................................................... 21
System overview ............................................................................. 22
Main features............................................................................ 22
Flowmeter ................................................................................ 22
Gas analysers............................................................................ 22
Environmental conditions measurements................................. 22
Before starting ................................................................................ 23
Checking the packing contents................................................. 23
Quark b2 standard packaging ......................................... 23
Warranty registration ..................................................................... 24
Register the product via software .................................. 24
How to contact COSMED ............................................. 24
Complain, feedback and suggestions ............................. 24
Options/Accessories ........................................................................ 25
PC configuration required .............................................................. 26
Technical features ........................................................................... 27
Flowmeter ...................................................................... 27
Oxygen Sensor (O2) ...................................................... 27
Carbon Dioxide Sensor (CO2) ....................................... 27
Humidity absorber ......................................................... 27
Power Supply ................................................................. 27
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Environmental Sensors .................................................. 27
Dimension and Weight .................................................. 27
Aux inputs...................................................................... 27
Measurements
28
Pulmonary function tests and measured parameters ....................29
Breath by Breath exercise testing............................................. 29
Indirect Calorimetry ................................................................. 29
Lactate Threshold (V-Slope) .................................................... 29
O2 Kinetics .............................................................................. 30
Spirometry Tests (option) ........................................................ 30
FVC - Forced Vital Capacity ......................................... 30
VC/IVC - Slow Vital Capacity and Ventilatory pattern 30
MVV - Maximum Voluntary Ventilation ...................... 31
Bronchoprovocation Response ...................................... 31
Installation
32
Unpacking the system .....................................................................33
Setting up the system ......................................................................34
Calibration Gas Cylinder ......................................................... 34
Gas pressure adjustment procedure.......................................... 34
Connecting cables and tubing.........................................................35
Cables and Tubing installation sequence ................................. 36
Assemble the turbine ......................................................................37
Assemble the mask and the flowmeter .......................... 37
Using the "Ultimate Seal" ........................................................ 37
Apply the seal to the mask ............................................. 38
To remove seal on mask ................................................ 38
Assembling the flowmeter for spirometry tests ....................... 38
Cardiac Output Module............................................................ 39
Connecting PC ......................................................................... 39
Software installation .......................................................................40
Installing the software .............................................................. 40
Run the software ...................................................................... 40
PC port configuration ............................................................... 40
Software main features ...................................................................41
Display ..................................................................................... 41
Tool bar .................................................................................... 41
Show/hide the toolbar .................................................... 41
Dialog windows ....................................................................... 41
Use of the keyboard ....................................................... 41
Use of the mouse ........................................................... 41
Scroll bars ................................................................................ 41
On line help .............................................................................. 41
Software version ...................................................................... 41
Calibration
42
Chapter 11 - Appendix - 3
Page 4
Calibrating sensors ......................................................................... 43
Running the Calibration program............................................. 43
Log file ..................................................................................... 43
Setting reference values ........................................................... 43
To set the reference values ............................................. 43
Calibrating analysers ................................................................ 44
Print the calibration report ....................................................... 44
Edit the calibration factors ....................................................... 44
Turbine calibration ......................................................................... 45
The calibration syringe .................................................. 45
Turbine calibration for ergospirometry tests ............................ 45
Assembling the flowmeter ............................................ 45
Calibrating the turbine ................................................... 46
Turbine calibration for the RMR test ....................................... 47
Assembling the flowmeter ............................................ 47
Calibrate the turbine....................................................... 47
Checking the system signals ........................................................... 48
The control panel ..................................................................... 48
Using the control panel .................................................. 48
Database Management
50
Exercise testing patient's database ................................................ 51
Enter a new patient ................................................................... 51
Find a patient ............................................................................ 51
Edit patient data ....................................................................... 51
Delete a patient......................................................................... 51
Archive maintenance ...................................................................... 52
Reorganise the archive ............................................................. 52
Delete the archive..................................................................... 52
Delete a test .............................................................................. 52
Backup and restore ................................................................... 52
Backup ........................................................................... 52
Restore ........................................................................... 52
Spirometry patient's database........................................................ 53
Patient Card.................................................................... 53
Visit Card ....................................................................... 53
Test Card ........................................................................ 54
Import/export a Tests card ....................................................... 54
Diagnosis Database .................................................................. 54
Spirometry program settings .......................................................... 55
Graphs ............................................................................ 55
Serial port....................................................................... 55
Units of measurements................................................... 55
Using extra fields ........................................................... 55
Customise the fields ....................................................... 55
Exercise testing
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56
Page 5
Recommendations for the exercise testing .....................................57
The evaluation of the cardiorespiratory function ..................... 57
Precautions ............................................................................... 57
Laboratory ..................................................................... 57
Ending the test ............................................................... 57
Preparing the patient ................................................................ 57
Before testing ................................................................. 57
Patient assent ................................................................. 58
Ending the test ............................................................... 58
Start Testing ....................................................................................59
Start a test ...................................................................... 59
Abort the test without saving data ................................. 59
End the test saving data ................................................. 59
View data in real-time .............................................................. 59
View graphs in real-time ............................................... 60
Parameters to view ................................................................... 60
Manual protocol ....................................................................... 60
Enter Load and Phase .................................................... 60
Set the markers .............................................................. 60
Automatic protocol .................................................................. 60
Modify the load during the test ...................................... 60
Set the BPM alarm ................................................................... 60
Enter the BPM ............................................................... 60
Data management ..........................................................................61
Viewing data ............................................................................ 61
View data in table form ................................................. 61
Creating graphs ........................................................................ 61
View data in graph form ................................................ 61
Customise the graphs ..................................................... 62
Switch from graph to data and vice versa ...................... 62
Viewing predicted values ......................................................... 63
View predicted values.................................................... 63
Anaerobic (Lactate) Threshold detection ................................. 63
View the Lactate Threshold ........................................... 63
Detect the Lactate Threshold ......................................... 63
Customise graphs for the LT viewing............................ 63
Fittings ..................................................................................... 64
Fit a graph with a linear regression ................................ 64
Fit a graph with a Mono-exponential regression ........... 64
Calculate the "Mean Value" .......................................... 65
Oxygen Kinetic ........................................................................ 65
Run the O2 Kinetic function .......................................... 65
Information about the Test ....................................................... 66
View the Information ..................................................... 66
Modify the information.................................................. 66
Summary .................................................................................. 66
Chapter 11 - Appendix - 5
Page 6
View the summary ......................................................... 66
Print the data ............................................................................ 66
Print the current window................................................ 67
Print the report ............................................................... 67
View the report......................................................................... 67
Data Editing .................................................................................... 68
Editing values and input numerical values .................... 68
Data filtering .................................................................. 68
Using the User fields...................................................... 69
Deleting steps ................................................................. 69
Advanced Editing .......................................................... 69
Restore the original test ................................................. 70
Overwrite the original test ............................................. 70
Customise the desktop.............................................................. 70
Customise the display colours ....................................... 70
Smart edit ................................................................................. 70
Apply the graphical noise suppression .......................... 70
Apply the threshold noise suppression .......................... 70
Customise the parameters ........................................................ 71
Create a new parameter.................................................. 71
Create a new predicted parameter .................................. 71
Exporting data .......................................................................... 72
Export a test ................................................................... 72
DDE with Excel ............................................................. 72
Creating Test Protocols ................................................................... 73
Create a new protocol .................................................... 73
Software configuration ................................................................... 74
Data viewing ............................................................................ 74
Select the parameters to view ........................................ 74
Select the parameters to view during the test................. 74
Sort the parameters ........................................................ 74
Steady State .............................................................................. 74
Customise the Steady State detection criteria ................ 74
Printout reports............................................................................... 75
Set up the printout .......................................................... 75
Select parameters to be printed ...................................... 75
Customise the printout header ....................................... 75
Electronic reports (*.pdf) ............................................... 76
Print the current window .......................................................... 76
Print the customised report....................................................... 76
Events management during exercise testing ................................. 77
Cardiac Output (option) ........................................................... 77
Setting up the Quark b2 for the cardiac output ............... 77
Performing a Cardiac Output test .................................. 78
Flow Volume loops .................................................................. 78
Flow Volume loop during the test ................................. 78
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Page 7
O2, CO2 vs Time ..................................................................... 79
O2, CO2 vs Time during the test ................................... 79
O2 Saturation (optional) .......................................................... 79
O2 Saturation during the test ......................................... 79
Spirogram................................................................................. 79
Spirogram during the test............................................... 79
View the events after the test ................................................... 80
Raw data................................................................................... 80
Save Raw data................................................................ 80
Resting Metabolic Rate Test
82
Metabolism ......................................................................................83
Total Metabolic Rate................................................................ 83
Resting Metabolic Rate (RMR) ............................................... 83
Importance to measure RMR ................................................... 83
Measure of the rest metabolic rate with indirect calorimetry... 83
How to perform a RMR test..................................................... 83
Recommendations ...........................................................................84
Resting metabolic rate test using the face mask....................... 84
Resting metabolic rate test using the canopy option ................ 84
Performing a test using the face mask ...........................................85
Calibrations .............................................................................. 85
How to prepare a patient .......................................................... 85
Start the test.............................................................................. 85
Viewing the test ....................................................................... 87
How to modify the average interval ......................................... 87
Print .......................................................................................... 88
Performing a test using the canopy option.....................................89
Calibrations .............................................................................. 89
How to prepare the canopy and the patient .............................. 89
Replacement of the power plug ..................................... 89
Connecting the Canopy.................................................. 89
How to prepare the patient ............................................. 90
Performing the test ................................................................... 90
Viewing the test ....................................................................... 91
How to modify the average interval ......................................... 91
Print .......................................................................................... 91
Sub-maximal Exercise Testing
92
Introduction .....................................................................................93
Pre-test screening ..................................................................... 93
Sub-maximal exercise testing .........................................................94
Considerations with sub-maximal exercise testing .................. 94
Staffing..................................................................................... 95
Test termination ....................................................................... 95
Considerations for accuracy ............................................................96
Performing the test .........................................................................97
Chapter 11 - Appendix - 7
Page 8
An example of testing protocol ................................................ 97
The mixing chamber
98
The mixing chamber ....................................................................... 99
Overview .................................................................................. 99
Preparing the mixing chamber for a test .................................. 99
Two-way non rebreathing valve description ............................ 99
Patient’s preparation............................................................... 100
Performing the test ................................................................. 100
Spirometry
102
Setting spirometry options............................................................ 103
Spirometry .............................................................................. 103
Automatic Interpretation .............................................. 103
Quality control ............................................................. 103
Parameters manager ............................................................... 104
Predicted values manager ....................................................... 104
Predicteds set ............................................................... 104
Set the current predicted .............................................. 105
Formula definition ....................................................... 105
Page set-up ............................................................................. 106
Spirometry tests ............................................................................ 107
Forced Vital Capacity (pre) ........................................................... 108
Recommendations .................................................................. 108
Perform a FVC (pre) test ........................................................ 108
Test encouragement ............................................................... 108
Perform the FVC test with the encouragement ............ 109
Slow Vital Capacity ....................................................................... 110
Perform a SVC test ................................................................ 110
Maximum Voluntary Ventilation ................................................... 111
Perform a MVV test ............................................................... 111
Bronchial Provocation Test ........................................................... 112
Bronchodilator test ................................................................. 112
Methacholine and Histamine Bronchial provocation Tests ... 112
Perform the test ...................................................................... 113
Bronchial Provocation protocols Database ............................ 113
Enter a new Bronchial provocation protocol in the
archive.......................................................................... 113
Viewing results ............................................................................. 114
Tests of the current patient........................................... 114
Delete a test .................................................................. 114
Printing results.............................................................................. 115
Printing Reports ..................................................................... 115
Printing the active window..................................................... 115
To print the active window .......................................... 115
Printing a series of reports...................................................... 115
Electronic reports (*.pdf) ....................................................... 115
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Page 9
Export data ............................................................................. 116
Export a test ................................................................. 116
System maintenance
118
System maintenance .....................................................................119
Cleaning and disinfection ...................................................... 119
Preparing the disinfecting solution .............................. 119
Cleaning the turbine flowmeter.............................................. 120
Precautions during the cleaning of the turbine ............ 120
Masks cleaning and disinfection ............................................ 120
Disassembling the different parts of the mask ............. 120
Cleaning the mask........................................................ 120
Disinfecting the mask .................................................. 120
Canopy bubblehood (option) cleaning ................................... 121
RMR reader (option) cleaning ............................................... 121
Precautions during the cleaning of the turbine ............ 121
Two-way non rebreathing valve cleaning (option) ................ 121
Mixing chamber cleaning and disinfection (option) .............. 121
Permapure maintenance ......................................................... 121
Inspections ............................................................................. 122
Replace the fuses.................................................................... 122
Select the proper power supply voltage ................................. 123
Appendix
124
Conformity declaration..................................................................125
Service - Warranty ........................................................................126
Warranty and limitation of liability ....................................... 126
Return goods policy for warranty or non warranty repair...... 126
Repair Service Policy ............................................................. 127
Privacy Information .......................................................................128
Personal data treatment and purposes .................................... 128
How your personal data are treated........................................ 128
The consent is optional, but… ............................................... 128
Holder of the treatment .......................................................... 128
Customer rights ...................................................................... 128
Waste of electrical and electronic equipment ...............................129
Analog - Digital auxiliary inputs...................................................130
AUX RS232 ........................................................................... 130
Pin-out assignment....................................................... 130
Handshaking protocol configuration ........................... 130
AUX1/ AUX4 analog Inputs.................................................. 130
Enable the AUX input ................................................. 130
Converting factors configuration ..................................................132
Pin-out assignment....................................................... 132
Heart Rate – TTL input ...................................................................133
Calculations references .................................................................134
Chapter 11 - Appendix - 9
Page 10
VO2 and VCO2 ...................................................................... 134
Anaerobic threshold (modified V-Slope) ............................... 134
O2 kinetics .............................................................................. 134
Cardiac Output ....................................................................... 134
ATS 94 recommendations ............................................................. 135
ATS recommendations ........................................................... 135
Predicted values ........................................................................... 136
Automatic diagnosis (algorithm)............................................ 137
Quality Control Messages ...................................................... 137
References..................................................................................... 139
Gas Exchange References ............................................ 139
Indirect calorimetry...................................................... 139
Cardiac Output ............................................................. 139
Spirometry ................................................................... 139
Sub-maximal testing .................................................... 139
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Page 11
Chapter 11 - Appendix - 11
Page 12
Getting started
Page 13
Important notices
Intended use
Quark b2 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 programme 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 b2 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.
• 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
Chapter 1 - Getting started - 13
Page 14
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 b2 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 b2, compliant with EN
60601-1 by means of an isolation transformer.
The Quark b2 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 b2.
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 b2 should not be used adjacent to or stacked with other equipment. If
adjacent or stacked use is necessary, the Quark b2 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
14 - Quark b2 User Manual
Page 15
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.
Chapter 1 - Getting started - 15
Page 16
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)].
16 - Quark b2 User Manual
•
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.
Page 17
EMC
Guidance and manufacturer’s declaration - electromagnetic emissions
The Quark b2 is intended for use in the electromagnetic environment specified below. The
customer or the user of the Quark b2 should assure that it is used in such an environment.
Emissions test
Compliance
Electromagnetic environment - guidance
RF emissions
Group 1
The Quark b2 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 b2 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.
Complies
Voltage Fluctuations /
Flicker Emission
IEC 61000-3-3
Guidance and manufacturer’s declaration - electromagnetic immunity
The Quark b2 is intended for use in the electromagnetic environment specified below. The
customer or the user of the Quark b2 should assure that it is used in such an environment.
Immunity test
Test level
Compliance level
Electromagnetic
environment - guidance
±6 kV contact
±6 kV contact
Electrostatic
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 b2 requires continued
operation during power mains
interruptions,
it
is
recommended that the Quark
b2 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.
Chapter 1 - Getting started - 17
Page 18
Guidance and manufacturer’s declaration - electromagnetic immunity
The Quark b2 is intended for use in the electromagnetic environment specified below. The
customer or the user of the Quark b2 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 b2, 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 b2 is used
exceeds the applicable RF compliance level above, the Quark b2 should be observed to verify
normal operation. If abnormal performance is observed, additional measures may be
necessary, such as reorienting or relocating the Quark b2.
b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
18 - Quark b2 User Manual
Page 19
Recommended separation distances between portable and mobile RF communications
equipment and the Quark b2
2
The Quark b is intended for use in an environment in which radiated RF disturbances are
controlled. The customer or the user of the Quark b2 can help prevent electromagnetic
interference by maintaining a minimum distance between portable and mobile RF
communications equipment (transmitters) and the Quark b2 as recommended below, according to
the maximum output power of the communications equipment..
Separation distance according to frequency of transmitter
Rated maximum
output power of
(m)
transmitter (W)
80 MHz to 800 MHz
800 MHz to 2.5 GHz
150 kHz to 80 MHz
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.
Chapter 1 - Getting started - 19
Page 20
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)
UNI EN ISO 13485:2003 (Registration n° 387-M Cermet)
Medical Device Directive (CE mark)
MDD 93/42/EEC (Notified Body 0476).
Class IIa
20 - Quark b2 User Manual
Page 21
Keynotes
Here are the keynotes used to make the manual easier to read.
Typographic keynotes
These are the typographic keynotes used in the manual.
Style
Description
Bold
“Italic”
indicates a control or a key to be pressed.
indicates a messages shown by the firmware.
Graphic keynotes
These are the graphic keynotes used in the manual.
Illustration
Description
shows the button to click in the software to activate the related feature.
Chapter 1 - Getting started - 21
Page 22
System overview
Main features
The Quark b2 unit contains the main items (analysers, electronic controls, valves...). It is
connected to the PC through an RS232 interface. The modular architecture allows to
replace the boards without any other technical service.
The unit can be used on a desktop or on the optional trolley, ideal for the Quark b2, the
cylinders, the PC, the printer…
Flowmeter
The system uses a bi-directional digital turbine. 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.
Gas analysers
The O2 and CO2 analysers are temperature-controlled and the internal pressure and
expired flow are monitored for an higher reliability if the measurements.
The Quark b² uses Nafion Permapure ® which is a semipermeable capillary tube
capable of removing the humidity in excess without altering the gas concentrations..
The analysers calibration is automatic and shows both graphically and numerically the
flow and concentration signals and the accuracy of the baseline/gain.
Environmental conditions measurements
The Barometric pressure is measured by an electronic pressure sensor inside the unit. It
has a measuring range between 400 mmHg and 800 mmHg. Ambient temperature and
relative humidity are measured by two sensors contained in the RH/TA probe. The
above measurements are used to calculate BTPS and STPD correction factors.
22 - Quark b2 User Manual
Page 23
Before starting
Before operating the Quark b2 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 b2 standard packaging
Code
C00930-01-04
C02120-01-05
C02170-01-11
A 800 900 001
C00243-01-06
C02210-02-08
C01399-02-12
C02910-01-10
C02911-01-10
C02912-01-10
C00861-01-06
A 661 200 001
A 661 200 002
A 182 310 001
C01804-02-11
C01348-01-06
A 388 010 004
A 362 060 001
A 362 300 001
A 680 013 630
A 680 024 125
C01790-01-36
C01999-01-DC
C00067-02-94
C01340-02-91
Qty
1
2
1
2
1
1
1
1
1
1
1
1
1
5
1
1
1
1
1
2
2
1
1
1
1
Description
Quark b2 ergo unit
Turbine Ø 28mm
Kit optoelectronic reader Quark ergometry
Head cap for the adult masks
Calibration Syringe 3L
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
Anti moisture filter
Calibration tube
External RH/TA probe
Filtered serial adapter
Power cord Schuko 2m
RS232 cable DB9 M/F
Time lag fuses 5x20 250V T630mA
Time lag fuses 5x20 250V T1,25A
PC software
Conformity declaration
Registration card
Quark b2 User Manual
Chapter 1 - Getting started - 23
Page 24
Warranty registration
Before using the system, please take a moment to fill in the registration form and the
warranty and return them to COSMED, by doing this you are eligible to the customers
assistance service.
For further information, please refer to the enclosed registration and warranty form. If
the form is not enclosed in the packaging, please contact directly COSMED.
Register the product via software
Together with the PC software, a registration software is supplied. With this software it
is possible to fill in an electronic form with the customer information.
1. To run the software, double click on the icon Registration or select Registration…
from ? menu.
2. Type the requested information and click Send… to send the form via e-mail to
COSMED.
How to contact COSMED
For any information you may need, please contact the manufacturer directly at the
following address:
COSMED S.r.l.
Via dei Piani di Monte Savello, 37
P.O. Box n. 3
00040 - Pavona di Albano
Rome - ITALY
Voice: +39 (06) 931.5492
Fax: +39 (06) 931.4580
email: customersupport@cosmed.it
Internet: http: //www.cosmed.it
Complain, feedback and suggestions
If you have any complain, feedback information or suggestion, please inform us at
complain@cosmed.it.
24 - Quark b2 User Manual
Page 25
Options/Accessories
The following options are available to enhance or to complete the Quark b2 system:
Code
A 860 000 004
C01500-01-04
C01700-01-04
A 870 150 001
C00689-01-30
C01278-01-30
C01277-01-30
A 800 900 004
C01396-01-11
C01234-01-11
C01402-01-11
C02150-01-11
C01380-01-12
A 180 015 001
Quantity
1
1
1
1
1
1
1
1
1
1
1
1
1
1
Description
Calibration cylinder (5% CO2, 16% O2, balance N2)
Trolley for Quark PFT
Trolley with arm for Quark PFT
Pressure regulator for calibration cylinder
Mask mouth/nose breath ID28 adult XL
Mask mouth/nose breath ID28 paediatric L
Mask mouth/nose breath ID28 paediatric S
Paediatric Headcap
Oxymeter
Heart rate monitor
Cardiac output
Spirometry
Extension oxymeter cable
Silica gel 500g
Chapter 1 - Getting started - 25