Cosmed Quark b User Manual

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 b

User manual, XVIII Edition

05/2008

COSMED Srl - Italy

http://www.cosmed.it

Part N. C00827-02-91

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 b

Warranty registration ..................................................................... 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

standard packaging ......................................... 23

2 - Quark b2 User Manual

Carbon Dioxide Sensor (CO2) ....................................... 27

Humidity absorber ......................................................... 27

Power Supply ................................................................. 27

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

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 56

4 - Quark b2 User Manual

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

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 b

for the cardiac output ............... 77

Performing a Cardiac Output test .................................. 78

Flow Volume loops .................................................................. 78

Flow Volume loop during the test ................................. 78

6 - Quark b2 User Manual

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

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

8 - Quark b2 User Manual

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

VO2 and VCO2 ...................................................................... 134

Anaerobic threshold (modified V-Slope) ............................... 134

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

10 - Quark b2 User Manual

Chapter 11 - Appendix - 11

Getting started

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 b

It is recommended to read carefully the following precautions before putting the device into operation.

The precautions reported below are of fundamental importance to assure the safety of all COSMED equipment users.

1. This user manual is to be considered as a part of the medical device and should

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

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

• ordinary equipment maintenance, inspections, disinfection and cleaning are

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

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

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

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

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

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

within Class II a.

always be kept on hand.

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

performed in the way and with the frequency described;

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

electrical parts must be replaced immediately by authorised personnel.

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

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

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

Chapter 1 - Getting started - 13

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

7. Cleaning residue, particulates, and other contaminates (including pieces of torn or broken components) in the breathing circuit pose a safety risk to the patient during testing procedures. Aspiration of contaminates can potentially be life-threatening. Use disposable anti-bacterial filters or disinfect each part in contact with the patient before each test.

8. You must follow all the cleaning procedures in System Maintenance, and you must thoroughly inspect the components after cleaning and before each patient test.

9. 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).

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

11. In accordance with their intended use Quark b

is not to be handled together with

other medical devices unless it is clearly declared by the manufacturer itself.

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

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

Quark b2, compliant with EN

60601-1 by means of an isolation transformer.

14. The Quark b

needs special precautions regarding EMC and needs to be installed and put into service according to the EMC information provided in the section EMC.

15. Portable and mobile RF communications equipment can affect the Quark b

16. 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.

17. The Quark b adjacent or stacked use is necessary, the Quark b

should not be used adjacent to or stacked with other equipment. If

should be observed to verify

normal operation in the configuration in which it will be used.

18. 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

Protective earth ground

Alternating current

14 - Quark b2 User Manual

Contraindication

The physical strain to execute the respiratory manoeuvre is contraindicated in case of some symptoms or pathology. The following list is not complete and must be considered as a piece of mere information.

Contraindications for the Spirometer tests

Absolute contraindications

For FVC, VC and MVV tests:

• Post-operating state from thoracic surgery

For FVC tests:

• Severe instability of the airways (such as a destructive bronchial emphysema)

• Bronchial non-specific marked hypersensitivity

• Serious problems for the gas exchange (total or partial respiratory insufficiency)

Relative contraindications

For FVC tests:

• spontaneous post-pneumothorax state

• arterial-venous aneurysm

• strong arterial hypertension

• pregnancy with complications at the 3

For MVV test:

• hyperventilation syndrome

month.

Contraindications for Bronchial provocation tests

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

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

Absolute contraindications

• Serious bronchial obstruction (FEV1 in adults)

• Recent myocardium infarct

• Recent vascular-cerebral accident

• Known arterial aneurysm

• Incapacity for understanding the provocation test procedures and its implications.

Relative contraindications

• Bronchial obstruction caused by the respiratory manoeuvre.

• Moderate or serious bronchial obstruction. For ex. 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

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.

16 - Quark b2 User Manual

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 b

should assure that it is used in such an environment.

Emissions test Compliance Electromagnetic environment - guidance

RF emissions CISPR 11

Group 1

The Quark b function. Therefore, its RF emissions are very low and

uses RF energy only for its internal

are not likely to cause any interference in nearby electronic equipment.

RF emissions CISPR 11

Harmonic Emission IEC 61000-3-2

Voltage Fluctuations /

Class B

Class A

Complies

The Quark b including domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.

is suitable for use in all establishments,

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 b

Immunity test Test level Compliance level

should assure that it is used in such an environment.

Electromagnetic

environment - guidance

Electrostatic discharge (ESD)

IEC 61000-4-2

±6 kV contact ±8 kV air

Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%.

Electrical fast transient/burst

IEC 61000-4-4

Surge IEC 61000-4-5

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

±2 kV for power supply lines

±1 kV for input/output lines

±1 kV differential mode

±2 kV common mode

<5% UT (>95% dip in U for 0.5 cycles

40% U

(60% dip in U 5 cycles

70% U

(30% dip in U 25 cycles

<5% UT (>95% dip in U for 5 sec

±2 kV for power supply lines

±1 kV for input/output lines

±1 kV differential mode

±2 kV common mode

<5% U

)

(>95% dip in U

for 0.5 cycles 40% U

) for

(60% dip in U

5 cycles 70% U

) for

(30% dip in U

25 cycles <5% UT

(>95% dip in U

)

for 5 sec

3 A/m 3 A/m

Mains power quality should be that of a typical commercial or hospital environment.

Mains power quality should

)

be that of a typical

commercial or hospital

environment. If the user of the Quark b

) for

operation during power mains

requires continued

interruptions, it is recommended that the Quark

) for

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

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 b

Immunity test Test level

Conducted RF IEC 61000-4-6

Radiated RF IEC 61000-4-3

3 Veff 150 kHz to

80 MHz

3 V/m 80 MHz to

2.5 GHz

should assure that it is used in such an environment.

Compliance

level

3 V

3 V/m

Electromagnetic environment -

guidance

Portable and mobile RF communications equipment should be used no closer to any part of the Quark b than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter

Recommended separation distance

d=1.17

d=2.33

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:

P 80 MHz to 800 MHz

P 800 MHz to 2.5 GHz

, including cables,

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 b exceeds the applicable RF compliance level above, the Quark b normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the Quark b

b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.

should be observed to verify

is used

18 - Quark b2 User Manual

Recommended separation distances between portable and mobile RF communications

equipment and the Quark b

The Quark b2 is intended for use in an environment in which radiated RF disturbances are controlled. The customer or the user of the Quark b

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..

Rated maximum

output power of transmitter (W)

Separation distance according to frequency of transmitter

(m)

150 kHz to 80 MHz

d=1.17

80 MHz to 800 MHz

d=1.17 P

800 MHz to 2.5 GHz

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

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

Keynotes

Here are the keynotes used to make the manual easier to read.

Typographic keynotes

These are the typographic keynotes used in the manual.

Style Description

Bold indicates a control or a key to be pressed.

“Italic” indicates a messages shown by the firmware.

Graphic keynotes

These are the graphic keynotes used in the manual.

Illustration Description

shows the button to click in the software to activate the related feature.

Chapter 1 - Getting started - 21

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 b cylinders, the PC, the printer…

Flowmeter

The system uses a bi-directional digital turbine. It opposes a very low resistance to flow (<0,7 cmH

motion which causes the rotation of the turbine rotor. The rolling blade interrupts the infrared light beamed by the three diodes of the optoelectronic reader. Every interruption represents 1/6 turn of the rotor, this allows to measure the number of turn in the time.

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.

, the

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

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

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 Qty Description

C00930-01-04 1 Quark b2 ergo unit

C02120-01-05 2 Turbine Ø 28mm

C02170-01-11 1 Kit optoelectronic reader Quark ergometry

A 800 900 001 2 Head cap for the adult masks

C00243-01-06 1 Calibration Syringe 3L

C02210-02-08 1 Permapure L2m

C01399-02-12 1 Cable in HR TTL

C02910-01-10 1 Mask mouth/nose breath adult S

C02911-01-10 1 Mask mouth/nose breath adult M

C02912-01-10 1 Mask mouth/nose breath adult L

C00861-01-06 1 HR probe

A 661 200 001 1 HR elastic belt

A 661 200 002 1 HR polar transmitter

A 182 310 001 5 Anti moisture filter

C01804-02-11 1 Calibration tube

C01348-01-06 1 External RH/TA probe

A 388 010 004 1 Filtered serial adapter

A 362 060 001 1 Power cord Schuko 2m

A 362 300 001 1 RS232 cable DB9 M/F

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

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

C01790-01-36 1 PC software

C01999-01-DC 1 Conformity declaration

C00067-02-94 1 Registration card

C01340-02-91 1 Quark b2 User Manual

Chapter 1 - Getting started - 23

Warranty registration

Before using the system, please take a moment to fill in the registration form and the warranty and return them to COSMED, by doing this you are eligible to the customers assistance service.

For further information, please refer to the enclosed registration and warranty form. If the form is not enclosed in the packaging, please contact directly COSMED.

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

Options/Accessories

The following options are available to enhance or to complete the Quark b2 system:

Code Quantity Description

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

C01500-01-04 1 Trolley for Quark PFT

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

A 870 150 001 1 Pressure regulator for calibration cylinder

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

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

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

A 800 900 004 1 Paediatric Headcap

C01396-01-11 1 Oxymeter

C01234-01-11 1 Heart rate monitor

C01402-01-11 1 Cardiac output

C02150-01-11 1 Spirometry

C01380-01-12 1 Extension oxymeter cable

A 180 015 001 1 Silica gel 500g

Chapter 1 - Getting started - 25

PC configuration required

• Pentium II 350 MHz.

• Windows XP, Vista

• 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

26 - Quark b2 User Manual

Technical features

Flowmeter

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

Ventilation Range: 0-300 litres x min

Oxygen Sensor (O2)

Type Zirconia temperature controlled Response time: <120 ms Range: 1-100% O Accuracy: ±0.01% O2

Carbon Dioxide Sensor (CO2)

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

Humidity absorber

Capillary of Nafion (Permapure ®)

O s/L @ 12 L/s

Power Supply

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

Environmental Sensors

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

Dimension and Weight

Dimensions: 17x30x45 cm Weight: 8 Kg

Aux inputs

Eight analog inputs (0-5, 0-10 Volts) for external measurement (HR, Pressure, ...). Digital (TTL) input for external ECG signal. Auxiliary RS 232 port for ergometers control (cicloergometers, treadmill…).

Chapter 1 - Getting started - 27

Measurements

Pulmonary function tests and measured parameters

Breath by Breath exercise testing

Symbol UM Parameter

VO2 ml/min Oxygen Uptake

VCO2

Vt l Tidal Volume

FetO2 % End Tidal O2

FetCO2 % End Tidal CO2

R --- Respiratory Quotient

VE l/min Ventilation

HR 1/min Heart Rate

Qt l Cardiac output

AT --- Anaerobic Threshold

VE l/min Ventilation

SV l/min Stroke volume

RF 1/min Respiratory Frequency

FeO2, FeCO2 % Averaged expiratory concentration of O2 e CO

VE/VO2 --- ventilatory equivalent for O2

VE/VCO2 --- ventilatory equivalent for CO2

VO2/HR ml/beat Oxygen pulse

VO2/Kg ml/min/Kg VO2 per Kg

Ti, Te, Ti/Ttot sec time breaths

Vd/Vt --- Vd/Vt ratio

PaCO2 mmHg arterial PCO2 (estimated)

P(a-et)CO2 mmHg Delta PaCO2 – PetCO2

ml/min

Carbon Dioxide production

Indirect Calorimetry

Symbol UM Parameter

EE Kcal/day Energy Expenditure

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

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

FAT Kcal/day Fats

CHO Kcal/day Carbohydrate

PRO Kcal/day Protein

FAT% % % Fat

CHO% % % Carbohydrate

PRO% % % Protein

npRQ —- Respiratory quotient not protein

Lactate Threshold (V-Slope)

Symbol UM Description

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

R @ LT -- Respiratory Quotient @ LT

Time @ LT hh:mm:ss Time @ LT

VCO2 ml/min CO2 output @ LT STPD

VE l/min Ventilation @ LT BTPS

Chapter 2 - Measurements - 29

HR bpm Heart Rate @ LT

O2 Kinetics

Parameter UM Calculation

O2 deficit l/m VO2@work*tau

O2 debt l/m VO2'@work*tau

Spirometry Tests (option)

FVC - Forced Vital Capacity

Symbol UM Parameter

FVC l Forced Expiratory Vital Capacity

FEV1 l Forced Expiratory Volume in 1 sec

FEV1/FVC% % FEV1 as a percentage of FVC

PEF l/sec Peak Expiratory Flow

FEV0.5 l Forced Expiratory Volume in 0.5 sec

FEV6 l Forced Expiratory Volume in 6 sec

FEV1/FEV6 % FEV1 as a percentage of FEV6

FEV6/FVC% % FEV6 as a percentage of FVC

Best FVC l Best Forced Expiratory Vital Capacity

Best FEV1 l Best Forced Expiratory Volume in 1 sec

Best PEF l/sec Best Peak Expiratory Flow

Vmax25% l/sec Expiratory Flow when 75% of the FVC remains to be exhaled

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

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

FEF25-75% l/sec Mid-exp flow between 25-75%FVC

FET100% sec Forced expiratory time

FEV2 l Forced Expiratory Volume in 2 sec

FEV3 l Forced Expiratory Volume in 3 sec

FEV2/FVC% % FEV2 as a percentage of FVC

FEV3/FVC% % FEV3 as a percentage of FVC

FEV1/VC% % Tiffenau index

FEF50-75% l/sec Mid-exp flow between 50-75%FVC

FEF75-85% l/sec Mid-exp flow between 75-85%FVC

FEF0.2-1.2% l/sec Mid-exp flow between 0.2 l - 1.2 l

FiVC L Inspiratory Forced Vital Capacity

FiF25-75% l/sec Forced mid-inspiratory flow

FiV1 l/sec Forced Inspiratory Volume in 1 sec

PIF l/sec Peak Inspiratory Flow

VEXT ml Extrapolated Volume (back extrapolation)

PEFT msec Time to PEF (10% - 90%)

30 - Quark b2 User Manual

VC/IVC - Slow Vital Capacity and Ventilatory pattern

Symbol UM Parameter

EVC l Expiratory Vital Capacity

IVC l Inspiratory Vital Capacity

ERV l Expiratory Reserve Volume

IRV l Inspiratory Reserve Volume

IC l Inspiratory Capacity

VE l/min Expiratory Minute Ventilation

Vt l Tidal Volume

Rf 1/min Respiratory Frequency

Ti sec Duration of Inspiration

Te sec Duration of Expiration

Ttot sec Duration of Total breathing cycle

Ti/Ttot —- Ti/Ttot ratio

Vt/ti l/sec Vt/ti ratio

MVV - Maximum Voluntary Ventilation

Symbol UM Parameter

MVV l/min Maximum Voluntary Ventilation

MVt l Tidal Volume (during MVV)

MRf 1/min Maximum Respiratory frequency

MVVt sec MVV duration time

Bronchoprovocation Response

Symbol UM Parameter

FallFEV1 % Fall in FEV1 from baseline or post diluent

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

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

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

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

Chapter 2 - Measurements - 31

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 b accessories can have place on the trolley as shown in the following illustration.

and

1. Quark unit

2. Printer

3. Calibration cylinder

4. Keyboard

5. Mouse pad

6. Table arm

7. Breathing valve

8. PC

9. Trolley

10. Bag

Chapter 3 - Installation - 33

Setting up the system

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

Calibration Gas Cylinder

In order to calibrate the sensors you need to have available calibration cylinder with the following gas concentration:

Cylinder Recommended Gas mixture

Calibration O2 16%, CO2 5%, N2 Bal

Gas pressure adjustment procedure

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

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

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



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

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

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

34 - Quark b2 User Manual

Connecting cables and tubing

The assembling procedure will be shown in the following illustrations.

A Flowmeter connector

B Power switch

C Sampling tube connector

D Calibration plug

E Oxymeter plug

F Cardiac Output plug

G, H, I, N Auxiliary analog inputs

L Calibration gas (16% O

, 5% CO2) connector

M Cardiac Output gas connector

O RH/TA probe connector

P RS232 Serial Port for PC connection

Q RS232 (for future extensions)

R HR probe connector

S RS232 Serial Port for ergometer connection

T Sampling pump input

U Power cable connector

V Switch 110V / 220V

Chapter 3 - Installation - 35

Cables and Tubing installation sequence

1. Connect the power cable of the Quark b2 to the trolley

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

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

4. Connect the O between 5 and 6 bar.

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

-CO2 calibration cylinder to the Quark b2 and adjust its pressure

(PC RS232) to the PC (COM1 or

36 - Quark b2 User Manual

Assemble the turbine

Assemble the mask and the flowmeter

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

2. Insert the turbine plug on the front panel.



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

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

Using the "Ultimate Seal"

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

• Will not irritate the skin

• Contains no adhesives.

• Has no odour

• Will not dry out

• Single patient use

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

1. Headcap

2. Mask

3. Inspiratory valve

4. Turbine

5. Optoelectronic reader

6. Sampling adapter

7. Sampling plug

Chapter 3 - Installation - 37

Apply the seal to the mask

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

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

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

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

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

To remove seal on mask

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

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

• To keep the seal clean between use, keep it attached to the mask and place the clear



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

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.

Assembling the flowmeter for spirometry tests

In case the spirometry kit option is purchased assemble the turbine as shown in the illustration below.

38 - Quark b2 User Manual

Cardiac Output Module

The Cardiac Output Module is provided with the Cardiac Output option and it consists of a special valve together with a bag that has to filled in with a different gas concentration (see Chapter 6 for further information).

Connecting PC

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

Chapter 3 - Installation - 39

Software installation

Note: The software can be installed on Windows XP or Vista It will not work on any previous versions of Windows.

The software consists of two programs: a spirometry program (uses a green CD, labelled PFT, option) and the program for ergometry (uses a blue CD, labelled CPET). The programs share the same archive and system calibration program.

One or both software programs may need to be installed depending on the device configuration.

Installing the software

Note: The software is copyright protected and should be installed only from the original disk.

1. Insert the installation CD into the CD-ROM drive.

2. The installation will begin automatically. If the disc does not start automatically you will need to run Setup.exe.

3. Follow the instructions given by the dialog boxes to complete the installation.

4. When the installation is finished, the program will alert you that the installation has been successfully completed.

Run the software

PC port configuration

Note: If both programs are installed, the directory for the CPET software should be the same as the PFT directory (default is C:\PFTSUITE).

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

2. Click the CPET or the PFTSuite icon.

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

For further details, see the chapter Database management.

40 - Quark b2 User Manual

Software main features

Display

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

Tool bar

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

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

Show/hide the toolbar

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

Dialog windows

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

Scroll bars

On line help

Use of the keyboard

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

field.

• Press the Enter key to confirm the information input on the dialog box or press the

Esc key to cancel changes.

Use of the mouse

• To move the cursor among fields, move the mouse on the desired field and left-

click.

• Click on the OK button with the Left button of the mouse to confirm the

information input on the dialog box or click on Cancel button to cancel changes.

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

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

bars

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

scroll fields

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

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

Software version

To know the software version and the serial number of the software, select About Quark b

Chapter 3 - Installation - 41

… from Help menu.

Calibration

Calibrating sensors

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

Running the Calibration program

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

Log file

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

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

Setting reference values

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

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

syringe (i.e. 3 litres).

and 0.03%

To set the reference values

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

1. Select Reference Values from the Calibration menu.

2. Type the correct values for the O

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

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

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

4. Press OK button to confirm changes.

Chapter 4 - Calibration - 43

Calibrating analysers



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

rocedure.

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

1. Remove the sampling line from the flowmeter.

2. Ensure that the O

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

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

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

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

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

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

Quark b

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

values… correspond to the certified composition of the mixture.

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.

44 - Quark b2 User Manual

Turbine calibration

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

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

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

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

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

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

The calibration syringe

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

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

Turbine calibration for ergospirometry tests

Before starting the calibration procedure, be sure that the turbine type is properly selected (in the calibration program, select File/Turbine results..., in the field Type (mm) must be entered 28).

Assembling the flowmeter

1. Connect the Opto-reader to the calibration syringe through the adapter.

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

Chapter 4 - Calibration - 45

1. Syringe

2. Silicone tube

3. Adaptor for calibration syringe.



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

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

Calibrating the turbine

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).

46 - Quark b2 User Manual

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

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

Turbine calibration for the RMR test

The turbine used for resting metabolic rate tests is different from the standard one (used for ergo-spirometric tests). Since the correction factors for the two turbines are different, before using this turbine, it is necessary to select and calibrate the turbine used.

In the calibration program, select File/Turbine results..., and enter 18 in the field Type (mm).

At the end of the RMR tests, before starting using the standard turbine, set 28 in the Type(mm) field and perform a turbine calibration with the standard turbine.

Assembling the flowmeter

Connect the RMR reader to the syringe by means of the proper adaptor.

Calibrate the turbine

Perform a turbine calibration according to the procedure described above. 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.

Chapter 4 - Calibration - 47

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 b

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).

mV / real values

display

Using the control panel

Sampling

pump on/off

RAW switch

on/off

Analog

input

Calibration

cylinder On/Off

Bag filling

Air valve

Bag valve

Oxymete

Deselect all

channels

Select all channels

Signal refresh

time

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Chapter 4 - Calibration - 49

Database

Management

Exercise testing patient's database

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

• Enter a new patient

• Find patient data

• Edit patient data

• Delete patient data.

Select Patients from the File menu.

Enter a new patient

1. Press New to show the Patient dialog box.

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

Find a patient

Edit patient data

Delete a patient

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

Or:

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

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

1. Select the patient.

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

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

1. Select the patient to be deleted.

2. Press Delete.

Chapter 5 - Database Management - 51

Archive maintenance

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

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

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

Reorganise the archive

1. Select Reorganize archive from the File menu.

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

Delete the archive

1. Select Initialize Archive from the File menu.

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

Delete a test

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

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

Backup and restore

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

Backup

1. Select Backup archive from the File menu.

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

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

Restore

1. Select Restore archive from the File menu.

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

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Spirometry patient's database

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

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



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

Patient Card

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

To move within the database use the following buttons:

Move to the first patient in the archive

Move to the previous patient in the archive

Move to the next patient in the archive

Move to the last patient in the archive

Find a patient in the archive

Enter a new patient in the archive

Delete current patient from the archive

Edit the current patient card

Visit Card

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

To move within the database use the following buttons:

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

Chapter 5 - Database Management - 53

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.

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Spirometry program settings

The 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 b2 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.

Chapter 5 - Database Management - 55

Exercise testing

Recommendations for the exercise testing

The evaluation of the cardiorespiratory function

The physical training requires the interaction of physiological mechanisms that allow the cardiovascular and respiratory systems to supply the increasing demand of energy due to the contraction of the muscles.

During the training the systems are both engaged, an adequate answer to the effort is the measure of theirs health state.

The increase of the metabolic rate, during the exercise, needs an appropriate increase of oxygen in the muscles. At the same time, the CO

in order to avoid the lactic acid making.

To satisfy the increase in the gas exchange, necessary to the muscles during the exercise, is requested the intervention of many physiological mechanisms. This process involves lungs, the pulmonary circulation, the heart and the peripheral circulation.

Precautions

The physician has the responsibility that the patient subjects to the test is a suitable person able to execute an effort test.

Laboratory

The room, in which the test is performed, must be big enough to contain the whole necessary equipment, allowing an easier accessibility to the patient in case of emergency.

In the room should be placed a thermometer and a hygrometer; the heart frequency and the perceived values of the effort rise as much as the ambient temperature increases, and the variability of the cardiovascular response grows for humidity values higher of 60%. Generally it is considered 22°C the temperature adequate for the test execution, even for short efforts, values till 26°C can be considered acceptable in presence of an efficient air ventilation.

muscles production must be removed

Ending the test

The patient should be monitored with ECG for at least 8 minutes, in resting conditions or until he returns to the pre-exercise conditions.

Preparing the patient

To enhance the value of a diagnostic test it’s very important patient collaboration. In most cases a well-informed patient will make a better effort (in relation to his conditions) and will allow a reliable interpretation of the test. For this reason every ergometric test must be preceded from a precise training of the patient.

Before testing

The physician applying the exam must be provided with a written request including a brief description of the diagnosis (confirmed or suspected ), the request’s reason and the patient therapy carried out showing the dose and time of the drug assumption.

To standardise the response to the test and reduce the patient’s anxiety it’s suggested to provide him either written (before the exam) or oral (at the same time of the test) information. At the scheduling time detailed instructions should be delivered to the patient, consisting in smoke and food abstinence three hours before an ergometric test, or eight hours before a scintigraphic test.

Test are usually executed supporting the therapeutic outline in progress, but sometimes it could be necessary to stop some drugs, such as b-block or calcium antagonist, which could impair the effort response reducing the diagnostic accuracy of the exam.

The patient must wear comfortable suit and gymnastic shoes and two hours before test stop any kind of drugs, eat light and avoid coffee and smoke.

Chapter 6 - Exercise Testing - 57

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.

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Start Testing



Note: Selecting “Simulated test”, the software allows to use the gas calibration in order to perform the test. This is useful if the user would check the accuracy of gas

Before starting exercise test type a new patient information or choose one from the list of patient in the file. As soon as a patient has been entered the software is ready to start a test. The name of the active patient is shown on the status bar of the program window.

Start a test

1. Calibrate the analysers as described in the Calibration chapter.

2. Choose Execute Test from the Test menu.

3. Enter or modify the antropometric data of the patient and select the options you

4. Select the ergometer you need to control

5. The software environment will change showing a new Menu bar and toolbar while

6. At this point the software starts showing data on the monitor but without saving

Abort the test without saving data

Choose Abort from the Test menu or press Alt+F3.

End the test saving data

1. Choose End from the Test menu or press F3.

2. Choose Yes to end the test or No to continue.

View data in real-time

The visualisation features and capabilities of the data and graphs are identical to the ones described in the Data management chapter. Starting the test a small window will appear on the right corner displaying time, bmp and, if selected before, the ergo protocol and trainer.

need to carry out the test . To use a specific protocol choose it in the list box and press OK to confirm.

the first data will be displayed in a table format.

them, this in order to monitor the patient before starting the test. To start storing data press F2.

Chapter 6 - Exercise Testing - 59

Parameters to view

the labe

View graphs in real-time

1. Choose Graph from the View menu.

2. Follow the instructions described in data management section to edit the graphs.

While the test is running, it is possible to choose the parameters to view.

1. Select Parameters to view/Test execution… from the Options menu.

2. Select the parameters and confirm.

Manual protocol



Tip: pressing the Shift key while choosing the marker option will allow you to enter

l for that marker.

Automatic protocol

Set the BPM alarm

If you are using the Quark with a treadmill without serial interface, it is possible to enter manually from the PC the event, the phase and the marker.

Enter Load and Phase

1. During the test select Load from the Events menu.

2. Select the phase and/or type the value of the load and press OK to confirm.

Set the markers

Select Marker from the Events menu.

The software allows to automatically control the ergometer according to the protocol previously selected. Anyway it is allowed to change it even after the test is started.

Modify the load during the test

1. During the test choose Ergometric protocol from the Events menu.

2. Select the row corresponding to the desired load and press OK to confirm.

The software allows the user to set the alarm level for the heart rate, in order to monitor the patient response.

Enter the BPM

1. Choose BPM alarm from the Events menu.

2. Set the alarm by moving the scroll bar and press OK to confirm.

It also allows to enable or disable the acoustic alarm by the option "Acoustic alarm".

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Data management

As soon as the test has been completed, all data stored can be retrieved for a complete management.

Viewing data

Data can be viewed in the following formats:

Table form numeric values of the various parameters (columns) corresponding to

Graphic form graphical presentation on Y1, Y2, X charts.

Summary results of the test and statistical analysis of the blocks.

Predicted predicted values, maximum value measured.

View data in table form

1. Select Data… from the View menu.

2. Select the test to visualise in the list box and press OK



Note: Double-click in the window to open the edit test.

each step (rows).

Creating graphs

The software is provided with powerful functions for creating charts. You can add custom graphs to create exactly what you need.

View data in graph form

1. Choose Graph… from the View menu.

2. Select the tests to visualise from the list and press OK

3. Choose the parameters you require on the X, Y1 and eventually for Y2; select if necessary some of the following options by pressing the more button and press OK to confirm.

It is possible to access quickly 5 common graphs from the View/Graph… dialog box.

Chapter 6 - Exercise Testing - 61



Note: Double-click in the graph window to o

en the edit test

Right-clicking, the graph can be exported in bmp file format.

Customise the graphs

1. With a graph on the screen, choose Customise graph from the View menu.

2. On the Customise graph dialog box, select options to obtain the wished graph.

Option Function

Grid on X, Y axes show the grid lines in correspondence with x or y axes that

make the graph easier for you to analyse data.

Autoscale maximum and minimum values of the graph will be measured

automatically.

Ignore 0 points with 0 value measured won't be shown.

Not interpolated make the graph scattered.

Marker highlight with a symbol all steps of the test in which the marker

button was pressed.

Squared makes the graph a square

Without recovery exclude from the graph all points of the recovery phase.

Mark points marks each point with a symbol

Min. Max. allows to set manually the axes values.

Step Set the axes' scale step.

Switch from graph to data and vice versa

When the active window is a graph (or a report in data form), it is possible to view very quickly the data (or the graph) corresponding to that test.

Choose Current test data (if the active window is a graph) or Current test graph… (if the active window is a data report) from the View menu.

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Viewing predicted values

For some parameter it is possible to compare the maximum value measured during the test with its predicted value and the LT value both in percentage and absolute.

View predicted values

Choose Predicted from the View menu.

Anaerobic (Lactate) Threshold detection

The software allows to detect the Lactate Threshold (Anaerobic Threshold) according to the "Modified V-slope method" reference. The LT can be detected both manually and automatically.



Note: Double-click in the window to open the corresponding dialog box.

View the Lactate Threshold

Choose Lactate Threshold from the View menu.

Detect the Lactate Threshold

1. Choose Calculate LT from the Test menu.

2. For calculating it automatically on the "Lactate Threshold" dialog box click on the Auto detect button.

3. For adjusting manually the point you want to detect, move the scroll bar on the dialog box by pressing the arrow buttons. Data and graph of the LT will be automatically redrawn.

4. Press Ok button to save your choices.

Customise graphs for the LT viewing

The software allows to customise two of the three graphs for the LT visualisation.

1. Choose Lactate Threshold from the Options menu.

2. Choose the parameters you want to be shown on the LT window and press OK to confirm your choices.

Chapter 6 - Exercise Testing - 63

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 VO

vs Load).

Fit a graph with a linear regression

1. Make active the graph window (any Y vs any X graph).

2. Right-click and select Fitting.

3. Choose Linear in the type combo box

4. Select the first point (X1) moving the mouse on the desired place in the graph pressing the Left key or using the + and – keys.

5. Select the second point (X2) moving the mouse on the desired place in the graph pressing the Right key or using the + and – keys.

6. Press OK to confirm.

Fit a graph with a Mono-exponential regression

1. Make active the graph window (any Y vs any X graph).

2. Right-click and select Fitting.

3. Choose Mono-exponential in the type combo box

4. Select the first point (X1) moving the mouse on the desired place in the graph pressing the Left key or using the + and – keys.

5. Select the second point (X2) moving the mouse on the desired place in the graph pressing the Right key or using the + and – keys.

6. 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).

7. Press OK to confirm.

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Oxygen Kinetic

Calculate the "Mean Value"

1. Make active the graph window (any Y vs any X graph).

2. Right-click and select Fitting.

3. Choose Mean value in the type combo box

4. Select the first point (X1) moving the mouse on the desired place in the graph pressing the Left key or using the + and – keys.

5. Select the second point (X2) moving the mouse on the desired place in the graph pressing the Right key or using the + and – keys.

6. 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.

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. Make active a VO2 vs Time graph window.

2. Press the right key of the mouse and select O2 Kinetic.

3. 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.

4. 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.

5. 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

Chapter 6 - Exercise Testing - 65

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.

Summary



Tip: double-clicking on the Summary window the function Options/Summary is activated by which you may configure the structure

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.

The summary feature allows to summarise test results according to the workload and phase during the test.

View the summary

1. Choose Summary from the View menu.

2. The summary of the current test (active window) will be displayed.

Print the data

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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.

View the report

Print the current window

1. Be sure that the current active window is the graph or the report you desire to print.

2. Select Print current window from File menu.

3. Press OK to print, or Setup to customise the print.

Print the report

1. Select the report to be printed from File menu.

2. Press OK to print, or Setup to customise the print.

3. To only view the report, without printing it, press Shift during the selection.

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.

Chapter 6 - Exercise Testing - 67

Data Editing



Nota: In Data view, doubleclick in the window to enter in “Data Editin

”.

The software allows the user to edit the data acquired during the test in the following ways:

• 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. Choose Edit test from the Test menu.

2. 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.

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Data filtering

1. Choose Edit test from the Test menu.

2. Press the button Filtering and choose the option Discard invalid steps to automatically eliminate all the invalid steps

3. 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.

4. 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.

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 deletes the steps meeting the selection criteria

Smoothing applies a moving average to the selected parameter

Edit parameter edits a parameter according to the selected criteria

Edit parameter Specifications

Value replaces the value of the selected parameter with a new one.

Correction % applies a percentage correction to the value of the selected

parameter.

Offset adds an offset to the value of the selected parameter.

Formula... replaces the value of the selected parameter with a

mathematical function.

Time range Specifications

From, To specifies the time range.

All steps applies the editing from the beginning to the end of the test.

Chapter 6 - Exercise Testing - 69

Apply to Specifications

Parameter specifies the reference parameter

>, >=, =, <, <=, <> higher than, higher or equal, equal to, lower than, lower or

Value/Formula… specifies the value (mathematical expression) compared

All steps do not use any selection criteria.

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. Select Colors from Options menu.

2. Select the item to be modified.

3. Press Change and select the desired colour.

equal, different

with the value of the specified parameter.

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. Make active a graph or a data window corresponding to the test that you want to modify.

2. Press the right key of the mouse and select Smart Edit.

3. Select the parameter that you want to modify.

4. 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.

5. If you want to cancel the edit press the Left key of the mouse.

6. Repeat the above mentioned procedure for the all parameters and press OK.

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Apply the threshold noise suppression

1. Make active a graph or data window corresponding to the test that you want to modify.

2. Press the Right key of the mouse and select Smart Edit.

3. Select the parameter that you want to modify.

4. Set a Noise(%) Threshold (as a percentage of the parameter value) above which any peak will be considered an artefact.

5. Press Execute and eventually Undo if you are not satisfied.

6. Press OK to confirm.

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. Choose Customise parameters from the Options menu.

2. Press the New button if you want to create a new parameter or Modify if you want to modify an existing one

3. 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.

4. 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.

Chapter 6 - Exercise Testing - 71

Exporting data

stalled

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. Choose Export Tests from the Test menu.

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

3. 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.

4. Select the folder, type the file name and press OK to confirm.



Note: The DDE function is available only if the user PC has Microsoft Excel

DDE with Excel

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.

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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. Choose Real Time > Ergom. Tests Protocols from the Options menu.

2. Press New and enter a name for the protocol.

3. In the field "Message Time" type a number that means to get a message to advise when switching to the next load.

4. Enable the "Drive Ergometer" check box to let the software control the ergometer. Select the "Initial Command" if the ergometer need it.

5. Enabling the option "Relative Increments", the loads refer to the previous step.

6. 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.

7. Press Add if you want to add a new step.

8. 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.

9. To delete a step, highlight the step and press Delete.

Chapter 6 - Exercise Testing - 73

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. Choose Parameters to view/Test visualisation… from the Options menu.

2. Select the parameters you require to view.

3. Press OK to confirm the selected configuration.

Select the parameters to view during the test

1. Choose Parameters to view/Test execution… from the Options menu.

2. Select the parameters you require to view.

3. 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. Choose Steady State from the Options menu

2. Type the desired values for Minimum number of steps, VO

threshold (%), VE

threshold (%) and R threshold.

The steps which satisfy these conditions will be highlighted with a yellow bar.

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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. Choose Reports from the Options menu.

2. 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.

3. 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. Choose Printout header from the Options menu.

2. On the "Report Header" dialog box type the text of the header.

3. 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.

4. Press OK to save the Printout header.

Chapter 6 - Exercise Testing - 75

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.

3. Set the sheet format and press OK.

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Events management during exercise testing

Cardiac Output (option)

The test is a non invasive method based on the measurement of the carbon dioxide during an exercise test for the indirect measurement of the Cardiac Output; the manoeuvre is composed by two different phases:

• Measurement of the metabolic parameters during a steady state condition (both at rest or during exercise, usually at the end of the 3

• Rebreathing in a bag previously filled with a high CO the CO

The method is base on the hypothesis that the PCO equal to the one of the lung capillaries.

The rebreathing phase consists in making the patient breathing into a bag (typically 5 litres) containing an high concentration of CO expired breath, brings to constant average value.

The optimum value of the CO workload, and can be desumed from the following table:

Load (W) CO2 concentration (%)

50 10.5/11.5 100 11.0/12.0 150 12.0/13.0

200 13.0/14.0 Balance O2.

The volume of the mixture filled in the bag must be 1.5 - 2 times the Vt of the patient.

concentration reached at the equilibrium.

concentration of the cylinder and the bag depends on the

minute of a 5 minutes step);

mixture and measurement of

in the alveolar gas is approximately

in O2 balance that, mixing with the

Note: The Cardiac Output must be carried out only with the mask without inspiratory valves or with the mouthpiece otherwise the results are not reliable.

Setting up the Quark b2 for the cardiac output

1. Connect and open the Cardiac Output cylinder to the corresponding input port on the rear panel (the output pressure of the gas must be between 4 and 5 bar).

2. Connect the valve to the corresponding connector of the front panel of the system.

3. Connect the rebreathing bag to the valve assembly.

Chapter 6 - Exercise Testing - 77

Performing a Cardiac Output test

1. Select Execute Test from the Test menu or press F2 and start the test as for an ergometry test.

2. During the desired phase (rest or exercise), in a steady state, select Cardiac Output from Test/Event… menu.

3. By using the corresponding buttons of the Toolbar prepare the bag by refilling it starting from completely collapsed (otherwise the initial concentration of CO

will

be lower than expected value and the results could be unreliable).

4. Connect the valve assembly to the output port of the turbine flowmeter trying not to affect too much the performance of the patient.

5. At the end of the expiration press F2 to start the rebreathing.

6. Stop the test by pressing F3 when the equilibrium is reached or wait for the automatic interruption after 20 seconds from the beginning of the rebreathing.

7. Close the Cardiac output event with the corresponding button on the Toolbar.

Flow Volume loops

Note: The values of VO

, VCO2 and R during the rebreathing and in the following 2

minutes are not reliable because of the high concentration of CO2.

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.

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Flow Volume loop during the test

1. Start with normal Exercise test and begin the memorisation of breath values (F2)

2. During a steady state select F/V loops form Test/Event...

3. 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. Start with normal Exercise test and begin the memorisation of breath values (F2)

2. During a steady state select O2, CO2 vs Time from Test/Event...

3. 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.

O2 Saturation during the test

1. Start with normal Exercise test and begin the memorisation of breath values (F2).

2. Select O2 Saturation from Test/Event...

3. As soon as 5 or 6 complete pulses have been acquired press F3 to stop the

Spirogram

The spirogram event allows to display and store the volume/time plot.

acquisition.

Spirogram during the test

1. Start with normal Exercise test and begin the memorisation of breath values (F2).

2. During a steady state select Spirogram form Test/Event...

3. Acquire volume/time plot until the window is filled and press F3 to stop the acquisition.

Chapter 6 - Exercise Testing - 79

View the events after the test

1. Select Data... from the View menu

2. 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.

It is possible to edit the Cardiac Output event in the following way:

5. Select Edit... from the Event menu to change the parameters measured during the steady state before the rebreathing, the CO calculation method.

Raw data

It's a particular feature with which the user can check and save some parameters (CO2 output, O sampling rate of 25 Hz.

Save Raw data

1. During the test choose Event from Events menu.

2. Select Raw Data from the list.

3. On the save data box give a name to the file and select the destination folder.

4. To stop saving Raw data press the stop icon or press F3 on the keyboard.

concentration and volumes) in Ascii file format in a archive apart at a

concentration at the equilibrium and the

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Chapter 6 - Exercise Testing - 81

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 % 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.

Measure 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 VO metabolism, expelled to atmosphere (CO 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

( heart , brain , lungs , liver , kidneys etc.) . RMR represents between 60

) and the amount of carbon dioxide, as a by-product of

output – VCO2). With these measurements

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 VO 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.

Chapter 7 - Resting Metabolic Rate Test - 83

and VCO2 changes

Recommendations

Before starting an RMR test, it is necessary to select and calibrate the turbine used. Read carefully the calibration procedure, in the Calibration chapter.

Resting metabolic rate test using the face mask

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. Verify (before and during the test) that the FeCO2 falls within the range 0.7%-1.3% and adjust the flow rate of the pump as necessary. If the FeCO should decrease the flow rate and if the FeCO flow rate. A low FeCO could be dangerous for the patient.

2. Do not place Canopy hood over a patient’s head before the tube is properly connected and a continuous flow is applied from Canopy Blower.

may result in unreliable measurements, while a high FeCO2

is too low you

is too high you should increase the

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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, as depicted in the following image. The mask has to be tight to the face, in order to avoid any air leakage.

Start the test

RM R

Make sure that the subject health status is acceptable according to what stated in the guidelines.

Make the subject sit or lay on a comfortable chair or bed.

Fix the mask to the subject, as illustrated in the above picture, pull the elastic strings (Point A and B) accurately in order to eliminate possible leaks. The mask must be perfectly sealed to the face of the subject, especially in correspondence with the nose (point C).

The mask adapt differently according to the face shape of the subject. The perfect position is therefore to be determined from subject to subject.

1. Enter in the ergometry program

2. Select a patient or add a new one (File/Patients...)

3. Select Start test from Test menu

Chapter 7 - Resting Metabolic Rate Test - 85

4. Enter the patient’s data and select the RMR mode (1st picture).

5. 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 (2

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 16

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

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:

• The average time interval (default: 10 minutes)



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…

• Average values of VO

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.

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.

, VCO2, R, RMR, RF, VE, HR, FAT% and CHO% and

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.

Chapter 7 - Resting Metabolic Rate Test - 87

The print of the current window generates a report similar to the one in the following page.

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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 CO 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.

production and, starting from these

Connecting the Canopy

1. Connect the Canopy unit to the mains by means of the medical grade AC/DC adapter provided.

2. Fix the vail to the bubblehood through the velcro strips.

3. 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.

4. Connect the bubblehood to the wrinkled tube, interposing a bacterial filter.

5. Connect the wrinkled tube to the unit through the Flow in connector.

6. Connect the optoelectronic reader of the K4 b

to the Flow out connector of the

Canopy unit.

Chapter 7 - Resting Metabolic Rate Test - 89

How to prepare the patient

1. 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.

2. 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.

3. After these checks, put the patient in a supine position.

4. Place the bubblehood with the vail on the patient’s head. The tube has to be placed near the patient’s mouth.

Warning! Do not place Canopy hood over a patient’s head before the tube is properly connected and a continuous flow is applied from Canopy Blower.

Performing the test

1. Enter in the ergometry program

2. Select a patient or add a new one (File/Patients...)

3. Select Start test from Test menu.

4. Enter the patient’s data and select the Canopy mode.

5. Confirm and start the test by pressing OK.

6. 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 FeCO

between 0.7% and 1.3%. FeCO2 values can be read on the right

side of the PC monitor.

7. When the FeCO acquisition. Verify, also during the test, that the measured FeCO

remains within the acceptability range, press F2 to start the data

is within the

0.7%-1.3% range. Otherwise, adjust it by means of the Flow adjustment handle.

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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.

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:

• The average time interval (default: 10 minutes)



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…

• Average values of VO

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 FeO 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

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.

, VCO2, R, RMR, VE, HR, FAT% and CHO% and predicted

and FeCO2 values are

The print of the current window generates a report similar to the one of the RMR test using the face mask.

Chapter 7 - Resting Metabolic Rate Test - 91

Sub-maximal

Exercise Testing

Introduction

Pre-test screening

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 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

Chapter 8 - Sub-maximal Exercise Testing - 93

Sub-maximal exercise testing

Heart rate varies linearly with VO2 to the point of maximum exertion; thus, VO be estimated using the relation between heart rate and VO

without subjecting the

2max

may

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 VO and extrapolated to the VO

). The steady-state heart rate at each work level is displayed graphically

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 VO

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 VO

2max

• 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 VO

slope of HR/VO

have a linear relation over a wide range of values; thus, the

regression can be extrapolated to an assumed maximum heart

rate.

• Mechanical efficiency (i.e., VO

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.

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Staffing

Test termination

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.

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.

Chapter 8 - Sub-maximal Exercise Testing - 95

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 VO and underestimate untrained individuals.

• The efficiency of motion during walking, running, and cycling varies.

• Cardiac output and VO

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

may overestimate trained individuals

2max

have a test-retest variability of 3-4%.

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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, 6

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 VO

5. Right-click on the graph and select VO

Edition Philadelphia: Williams&Wilkins, 2000:22-29]).

/Kg vs. HR plot

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 YMCA cycle ergometry protocol is defined as follows.

step: workload 150 kgm/min

step: if the HR at the end of the 1st step is: <80 80-89 90-100 >100

set the workload at (kgm/min) 750 600 450 300

step: if the HR at the end of the 2nd step is: <80 80-89 90-100 >100

set the workload at (kgm/min) 900 750 600 450

step: if the HR at the end of the 3rd step is: <80 80-89 90-100 >100

set the workload at (kgm/min) 1050 900 750 600

Chapter 8 - Sub-maximal Exercise Testing - 97

The mixing chamber

Overview

The mixing chamber is a 7-litres plexiglas box, for exercise or resting (VE<40 l/min) tests. For resting tests only a part (about 2.3 litres) of the mixing chamber is used.

The mixing chamber is shown in the following picture:

1. Connector for the sampling line, for resting tests or tests with VE<40 l/min.

2. Connector for the sampling line, for exercise tests or tests with VE>40 l/min.

3. Inlet for patient’s exhaled air.

4. Connector to be closed with the proper plug supplied with the equipment.

5. Outlet for patient’s exhaled air.

6. Little plug for closing the connectors #1 or #2.

7. Fixing holes.

Preparing the mixing chamber for a test

1. Connect the wrinkled tube to the inlet #3 of the mixing chamber.

2. Connect the turbine to the outlet #5 of the mixing chamber.

3. Disconnect the sampling line from the turbine and connect it to the connector #1 (for resting tests) or #2 (for exercise tests) of the mixing chamber.

4. Close the connector #2 (for resting tests) or #1 (for exercise tests) of the mixing chamber with the little plug #6.

5. Close the connector #4 with the proper plug supplied with the equipment.

Two-way non rebreathing valve description

The two-way non rebreathing valve is very important in order to perform the test properly. It is shown in the following picture:

The mixing chamber - 99

1. Valve inlet

2. Connector for the mask

3. Valve outlet

Note: be very careful in order to differentiate inlet from outlet. These two are not interchangeable, to guarantee proper functionality.

Patient’s preparation

1. Screw the mask to the connector #2 of the valve.

2. Connect the wrinkled tube to the outlet #3 of the valve.

3. Fix the mask as illustrated in the picture below. Adjust the elastic bands on the head

cap as necessary to eliminate possible leaks and create a tight seal around the subject’s face.

Performing the test

100 - Quark b2 User Manual

4. Complete the patient preparation as indicated in the chapter Exercise testing.

1. Calibrate the analyzers as described in the Calibration chapter

2. Select Test/Execute Test or press the icon

3. Select Mixing chamber in the Execute test window and perform the exercise/resting test as illustrated in the chapter Exercise testing.

or press F2.

Cosmed Quark b User Manual

Specifications and Main Features

Frequently Asked Questions

User Manual