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 .
2
K4 b
User manual, XVIII Edition
05/2008
Copyright © 1998 COSMED
Copyright © 2003 COSMED
COSMED Srl - Italy
http://www.cosmed.it
Part N. C01508-02-91
Table of contents
Getting started 13
Important notices ............................................................................ 14
Intended use ............................................................................. 14
Warnings .................................................................................. 14
Contraindication ............................................................................. 17
Contraindications for the Spirometer tests ............................... 17
Absolute contraindications............................................. 17
Relative contraindications .............................................. 17
Contraindications for Bronchial provocation tests ................... 17
Absolute contraindications............................................. 17
Relative contraindications .............................................. 17
Contraindications for Exercise testing ..................................... 17
Environmental condition of use ...................................................... 18
EMC ................................................................................................. 19
Safety and conformity ..................................................................... 22
Safety ............................................................................. 22
EMC ............................................................................... 22
Telemetry ....................................................................... 22
Quality Assurance .......................................................... 22
Medical Device Directive (CE mark) ............................ 22
FCC (only USA version) ............................................... 22
Keynotes ......................................................................................... 23
Typographic keynotes .............................................................. 23
Graphic keynotes ...................................................................... 23
System overview ............................................................................. 24
Portable Unit (PU) ................................................................... 24
Telemetry Data Transmission, Receiver Unit (RU) ................. 24
Battery Charger Unit (CU) ....................................................... 24
Flowmeter ................................................................................ 25
Gas analysers ............................................................................ 25
PC Software ............................................................................. 25
Before starting ................................................................................ 26
Checking the packing contents ................................................. 26
Warranty registration ..................................................................... 27
Register the product via software .................................. 27
How to contact COSMED ............................................. 27
Complain, feedback and suggestions ............................. 27
Options/Accessories ........................................................................ 28
Accessories ............................................................................... 28
Options ..................................................................................... 28
Telemetry data transmission .......................................... 28
Spirometry Kit ............................................................... 28
2 - K4 b2 User Manual
PC configuration required ............................................................... 29
Technical features ........................................................................... 30
Portable Unit .................................................................. 30
Receiver Unit ................................................................. 30
Battery charger Unit ...................................................... 30
Flowmeter ...................................................................... 30
Oxygen Sensor (O
) ....................................................... 30
2
Carbon Dioxide Sensor (CO2) ....................................... 30
Humidity absorber ......................................................... 30
Power Supply ................................................................. 30
Environmental Sensors .................................................. 30
Measurements 31
Pulmonary function tests and measured parameters .................... 32
Breath by Breath exercise testing ............................................. 32
Indirect Calorimetry ................................................................. 32
Lactate Threshold (V-Slope) .................................................... 32
O2 Kinetics .............................................................................. 33
Spirometry Tests (option) ........................................................ 33
FVC - Forced Vital Capacity ......................................... 33
VC/IVC - Slow Vital Capacity and Ventilatory pattern 33
MVV - Maximum Voluntary Ventilation ...................... 34
Bronchoprovocation Response ...................................... 34
Installation 35
Installation sequence ...................................................................... 36
Battery Charger Unit ................................................................ 36
Check voltage ................................................................ 36
Turn the Unit on............................................................. 36
Charge the batteries ....................................................... 36
Battery low .................................................................... 37
Portable Unit ............................................................................ 37
Warm up ........................................................................ 38
Warming-up the unit by main power ............................. 38
Turning on/off the portable unit..................................... 38
Connect the rechargeable battery ................................... 38
Receiver Unit ........................................................................... 39
Turning on/off the receiver unit ..................................... 39
Receiver unit power supply ........................................... 39
Calibration Gas Cylinder ......................................................... 39
Connecting the K4 b2 to the patient ................................................ 40
Assemble the mask and the flowmeter .................................... 40
Using the "Ultimate Seal" ........................................................ 40
Apply the seal to the mask ............................................. 41
To remove seal on mask ................................................ 41
Assembling the flowmeter for spirometry tests ....................... 41
Index - 3
Fixing the K4 b2 to the patient ................................................. 42
Connecting the K4 b2 to the PC ....................................................... 43
Connect the Portable Unit to the PC ........................................ 43
Connect the Receiver Unit to the PC ....................................... 43
Software installation ....................................................................... 44
Installing the software .............................................................. 44
Run the software ...................................................................... 44
PC port configuration ............................................................... 44
Software main features .................................................................. 45
Display ..................................................................................... 45
Tool bar .................................................................................... 45
Show/hide the toolbar .................................................... 45
Dialog windows ....................................................................... 45
Use of the keyboard ....................................................... 45
Use of the mouse ............................................................ 45
Scroll bars ................................................................................ 45
On line help .............................................................................. 45
Software version ...................................................................... 45
Calibration 47
Gas calibration procedures ............................................................ 48
Running the Calibration program ............................................. 48
Log file ..................................................................................... 48
Setting reference values ........................................................... 48
Set the reference values using the PC software ............. 48
Set the reference values using the Portable Unit ............ 49
Room air calibration ................................................................. 49
Room air calibration using the PC software .................. 49
Room air calibration using the Portable Unit ................ 49
Reference gas calibration ......................................................... 50
The calibration unit ........................................................ 50
Reference gas calibration using the PC software ........... 50
Reference gas calibration using the Portable Unit ......... 51
Gas delay calibration ................................................................ 52
Delay calibration using the PC software ........................ 52
Delay calibration using the Portable Unit ...................... 53
Print the calibration report ....................................................... 53
Edit the calibration factors ....................................................... 53
Turbine calibration ......................................................................... 54
The calibration syringe .................................................. 54
Turbine calibration for ergospirometry tests ............................ 54
Assembling the flowmeter ............................................ 54
Calibrating the turbine ................................................... 55
Turbine calibration for the RMR test ....................................... 56
Assembling the flowmeter ............................................ 56
Calibrate the turbine ....................................................... 57
4 - K4 b2 User Manual
Checking the system signals ........................................................... 58
The control panel ..................................................................... 58
Using the control panel .................................................. 58
Operating modes 59
K4 b2 Operating modes .................................................................. 60
Holter Data Recorder ............................................................... 60
Telemetry Data Transmission (option) .................................... 60
Serial (Laboratory) Station....................................................... 60
Portable Unit User Interface diagram ............................................ 61
Holter Data Recorder Mode ............................................................ 62
Operating sequence .................................................................. 62
Warming-up the system ................................................. 62
Enter new patient ........................................................... 62
Calibrate and start the test .............................................. 62
Stop the test ................................................................... 63
Transferring test to PC ................................................... 63
Telemetry Data Transmission Mode................................................ 64
Operating sequence .................................................................. 64
Warming-up the system ................................................. 64
Connect the receiver unit to the PC ............................... 64
Enable transmission ....................................................... 64
Enter new patient ........................................................... 64
Enable reception on PC ................................................. 65
Calibrate and start the test .............................................. 65
Stop the test ................................................................... 66
Transferring test to PC ................................................... 66
Serial Mode ..................................................................................... 67
Operating sequence .................................................................. 67
Warming-up the system ................................................. 67
Connect the Portable unit to the PC ............................... 67
Calibrate the system ....................................................... 67
Enter patient data ........................................................... 67
Start the test ................................................................... 68
Stop the test ................................................................... 68
Database Management 69
Exercise testing patient's database ................................................. 70
Enter a new patient ................................................................... 70
Find a patient ............................................................................ 70
Edit patient data ....................................................................... 70
Delete a patient ........................................................................ 70
Uploading tests from the Portable Unit .......................................... 71
Archive maintenance ...................................................................... 72
Reorganise the archive ............................................................. 72
Delete the archive .................................................................... 72
Delete a test .............................................................................. 72
Index - 5
Backup and restore ................................................................... 72
Backup ........................................................................... 72
Restore ........................................................................... 72
Spirometry patient's database........................................................ 73
Patient Card .................................................................... 73
Visit Card ....................................................................... 73
Test Card ........................................................................ 74
Import/export a Tests card ....................................................... 74
Diagnosis Database .................................................................. 74
Spirometry program settings .......................................................... 75
Graphs ............................................................................ 75
Serial port ....................................................................... 75
Units of measurements ................................................... 75
Using extra fields ........................................................... 75
Customise the fields ....................................................... 75
Exercise testing 77
Recommendations for the exercise testing ..................................... 78
The evaluation of the cardiorespiratory function ..................... 78
Precautions ............................................................................... 78
Laboratory ...................................................................... 78
Ending the test ............................................................... 78
Preparing the patient ................................................................ 78
Before testing ................................................................. 78
Patient assent .................................................................. 79
Ending the test ............................................................... 79
Real time test .................................................................................. 80
Start a test....................................................................... 80
Abort the test without saving data ................................. 80
End the test saving data ................................................. 80
View data in real-time .............................................................. 80
View graphs in real-time ................................................ 80
Parameters to view ................................................................... 80
Manual protocol ....................................................................... 81
Enter Load and Phase .................................................... 81
Set the markers ............................................................... 81
Automatic protocol................................................................... 81
Modify the load during the test ...................................... 81
Set the BPM alarm ................................................................... 81
Enter the BPM ............................................................... 81
Data management .......................................................................... 82
Viewing data ............................................................................ 82
View data in table form ................................................. 82
Creating graphs ........................................................................ 82
View data in graph form ................................................ 82
Customise the graphs ..................................................... 83
6 - K4 b2 User Manual
Switch from graph to data and vice versa ...................... 83
Viewing predicted values ......................................................... 84
View predicted values .................................................... 84
Anaerobic (Lactate) Threshold detection ................................. 84
View the Lactate Threshold ........................................... 84
Detect the Lactate Threshold ......................................... 84
Customise graphs for the LT viewing ............................ 84
Fittings ..................................................................................... 85
Fit a graph with a linear regression ................................ 85
Fit a graph with a Mono-exponential regression ........... 85
Calculate the "Mean Value" .......................................... 86
Oxygen Kinetic ........................................................................ 86
Run the O2 Kinetic function .......................................... 86
Information about the Test ....................................................... 87
View the Information ..................................................... 87
Modify the information .................................................. 87
Summary .................................................................................. 87
View the summary ......................................................... 87
Print the data ............................................................................ 87
Print the current window ............................................... 88
Print the report ............................................................... 88
View the report ........................................................................ 88
Data Editing .................................................................................... 89
Editing values and input numerical values .................... 89
Data filtering .................................................................. 89
Using the User fields ..................................................... 90
Deleting steps................................................................. 90
Advanced Editing .......................................................... 90
Restore the original test ................................................. 91
Overwrite the original test ............................................. 91
Customise the desktop ............................................................. 91
Customise the display colours ....................................... 91
Smart edit ................................................................................. 91
Apply the graphical noise suppression .......................... 91
Apply the threshold noise suppression .......................... 91
Customise the parameters ........................................................ 92
Create a new parameter ................................................. 92
Create a new predicted parameter .................................. 92
Exporting data .......................................................................... 93
Export a test ................................................................... 93
DDE with Excel ............................................................. 93
Creating Test Protocols .................................................................... 94
Create a new protocol .................................................... 94
Software configuration .................................................................... 95
Data viewing ............................................................................ 95
Select the parameters to view ........................................ 95
Index - 7
Select the parameters to view during the test ................. 95
Sort the parameters ........................................................ 95
Steady State .............................................................................. 95
Customise the Steady State detection criteria ................ 95
Printout reports ............................................................................... 96
Set up the printout .......................................................... 96
Select parameters to be printed ...................................... 96
Customise the printout header ....................................... 96
Electronic reports (*.pdf) ............................................... 97
Print the current window .......................................................... 97
Print the customised report ....................................................... 97
Events management during exercise testing ................................. 98
Flow Volume loops .................................................................. 98
Flow Volume loop during the test ................................. 98
O2, CO2 vs Time ..................................................................... 98
O2, CO2 vs Time during the test ................................... 98
O2 Saturation (optional) ........................................................... 99
O2 Saturation during the test ......................................... 99
Spirogram ................................................................................. 99
Spirogram during the test ............................................... 99
View the events after the test ................................................... 99
Raw data ................................................................................... 99
Save Raw data .............................................................. 100
Resting Metabolic Rate Test 101
Metabolism ................................................................................... 102
Total Metabolic Rate .............................................................. 102
Resting Metabolic Rate (RMR) ............................................. 102
Importance to measure RMR ................................................. 102
Measure of the rest metabolic rate with indirect calorimetry . 102
How to perform a RMR test ................................................... 102
Recommendations ........................................................................ 103
Resting metabolic rate test using the face mask ..................... 103
Resting metabolic rate test using the canopy option .............. 103
Performing a test using the face mask ......................................... 104
Calibrations ............................................................................ 104
How to prepare a patient ........................................................ 104
Start the test ............................................................................ 104
Viewing the test ..................................................................... 106
How to modify the average interval ....................................... 106
Print ........................................................................................ 107
Performing a test using the canopy option .................................. 108
Calibrations ............................................................................ 108
How to prepare the canopy and the patient ............................ 108
Replacement of the power plug ................................... 108
Connecting the Canopy ................................................ 108
8 - K4 b2 User Manual
How to prepare the patient ........................................... 109
Performing the test ................................................................. 109
Viewing the test ..................................................................... 110
How to modify the average interval ....................................... 110
Print ........................................................................................ 110
Sub-maximal Exercise Testing 111
Introduction ................................................................................... 112
Pre-test screening ................................................................... 112
Sub-maximal exercise testing ....................................................... 113
Considerations with sub-maximal exercise testing ................ 113
Staffing ................................................................................... 114
Test termination ..................................................................... 114
Considerations for accuracy .......................................................... 115
Performing the test ....................................................................... 116
An example of testing protocol .............................................. 116
The mixing chamber 117
The mixing chamber...................................................................... 118
Overview ................................................................................ 118
Preparing the mixing chamber for a test ................................ 118
Two-way non rebreathing valve description .......................... 118
Patient’s preparation .............................................................. 119
Performing the test ................................................................. 119
Spirometry 121
Setting spirometry options ............................................................ 122
Spirometry.............................................................................. 122
Automatic Interpretation .............................................. 122
Quality control ............................................................. 122
Parameters manager ............................................................... 123
Predicted values manager....................................................... 123
Predicteds set ............................................................... 123
Set the current predicted .............................................. 124
Formula definition ....................................................... 124
Page set-up ............................................................................. 125
Spirometry tests............................................................................. 126
Forced Vital Capacity (pre) ............................................................ 127
Recommendations .................................................................. 127
Perform a FVC (pre) test ........................................................ 127
Test encouragement ............................................................... 127
Perform the FVC test with the encouragement ............ 128
Slow Vital Capacity ........................................................................ 129
Perform a SVC test ................................................................ 129
Maximum Voluntary Ventilation ................................................... 130
Perform a MVV test ............................................................... 130
Bronchial Provocation Test ............................................................ 131
Index - 9
Bronchodilator test ................................................................. 131
Methacholine and Histamine Bronchial provocation Tests ... 131
Perform the test ...................................................................... 132
Bronchial Provocation protocols Database ............................ 132
Enter a new Bronchial provocation protocol in the
archive .......................................................................... 132
Viewing results ............................................................................. 133
Tests of the current patient ........................................... 133
Delete a test .................................................................. 133
Printing results.............................................................................. 134
Printing Reports ..................................................................... 134
Printing the active window ..................................................... 134
To print the active window .......................................... 134
Printing a series of reports ...................................................... 134
Electronic reports (*.pdf) ....................................................... 134
Export data ............................................................................. 135
Export a test ................................................................. 135
External devices 137
GPS ............................................................................................... 138
GPS initialisation ................................................................... 138
Initialize the GPS ......................................................... 138
Fixing the antenna to the subject ............................................ 138
Operating sequence ................................................................ 139
Run a test with GPS ..................................................... 139
Monitoring GPS parameters in real time ..................... 140
Pulse Oximeter (option) ................................................................ 141
Operating Sequence ............................................................... 141
System maintenance 143
System maintenance ..................................................................... 144
Cleaning and disinfection ....................................................... 144
Preparing the disinfecting solution .............................. 144
Cleaning the turbine flowmeter .............................................. 145
Precautions during the cleaning of the turbine ............ 145
Masks cleaning and disinfection ............................................ 145
Disassembling the different parts of the mask ............. 145
Cleaning the mask ........................................................ 145
Disinfecting the mask .................................................. 145
Canopy bubblehood (option) cleaning ................................... 146
RMR reader (option) cleaning ............................................... 146
Precautions during the cleaning of the turbine ............ 146
Two-way non rebreathing valve cleaning (option) ................ 146
Mixing chamber cleaning and disinfection (option) .............. 146
Permapure maintenance ......................................................... 146
Inspections ............................................................................. 147
Replace the fuses .................................................................... 147
10 - K4 b2 User Manual
Appendix 149
Conformity declaration .................................................................. 150
Service - Warranty ........................................................................ 151
Warranty and limitation of liability ....................................... 151
Return goods policy for warranty or non warranty repair ...... 151
Repair Service Policy ............................................................. 152
Privacy Information ....................................................................... 153
Personal data treatment and purposes .................................... 153
How your personal data are treated ........................................ 153
The consent is optional, but… ............................................... 153
Holder of the treatment .......................................................... 153
Customer rights ...................................................................... 153
Waste of electrical and electronic equipment ............................... 154
Converting factors configuration .................................................. 155
Calculations references ................................................................. 156
VO2 and VCO2 ...................................................................... 156
Anaerobic threshold (modified V-Slope) ............................... 156
kinetics .............................................................................. 156
O
2
ATS 94 recommendations .............................................................. 157
ATS recommendations ........................................................... 157
Predicted values ............................................................................ 158
Automatic diagnosis (algorithm) ........................................... 159
Quality Control Messages ...................................................... 159
References ..................................................................................... 161
Gas Exchange References ............................................ 161
Indirect calorimetry ..................................................... 161
Spirometry ................................................................... 161
Sub-maximal testing .................................................... 161
Index - 11
12 - K4 b2 User Manual
Getting started
Important notices
Intended use
The measurement of oxygen uptake during sport or real life activities is of great interest
for the development of training programs and the study of their effects on elite athletes
or for assessing the efficacy of a rehabilitation therapy.
A common method for assessing the effects of endurance training is the monitoring of
various respiratory parameters during submaximal exercise.
One difficulty to achieve this goal during sport that cannot be simulated in the
laboratory is to use a reliable and valid portable system to measure VO
field setting.
Such a portable apparatus may also be useful to determine the energy cost of many sport
and real life activities.
K4 b
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.
and VCO2 in a
2
2
is an electrical medical device designed to perform pulmonary function tests. It is
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 K4 b
2
within Class II a.
It is recommended to read carefully the following precautions before putting the device
into operation.
The precautions reported below are of fundamental importance to assure the safety of
all COSMED equipment users.
1. This user manual is to be considered as a part of the medical device and should
always be kept on hand.
2. Safety, measure accuracy and precision can be assured only:
• using the accessories described in the manual or given with the device. Actually
non recommended accessories can affect safety unfavourable. Before using non
recommended accessories it is necessary to get in touch with the manufacturer;
• ordinary equipment maintenance, inspections, disinfection and cleaning are
performed in the way and with the frequency described;
• any modification or fixing is carried out by qualified personnel;
• the environmental conditions and the electrical plants where the device operates
are in compliance with the specifications of the manual and the present regulations
concerning electrical plants. In particular grounding reliability and leakage current
suppression can only be assured when the device three – wire receptacle is
connected to a yellow - green return connected to earth ground. Attempting to
defeat the proper connection of the ground wire is dangerous for users and
equipment.
14 - K4 b2 User Manual
3. Before powering the system, check the power cables and the plugs. Damaged
electrical parts must be replaced immediately by authorised personnel.
4. Large gas cylinders, which may be given by the manufacturer or purchased by the
customer, should be secured with cylinder safety chains or safety stands.
5. When removing the protective cap, inspect the cylinder valve for damaged threads,
dirt, oil or grease. Remove any dust or dirt with a clean cloth. If oil or grease is
present on the valve of a cylinder which contains oxygen, do not attempt to use.
Such combustible substances in contact with oxygen are explosive.
6. Be certain that the materials of the pressure regulators are chemically compatible
with the intended gas service before installation. Inspect the regulator for the proper
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 K4 b
2
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
K4 b2, compliant with EN 60601-1
by means of an isolation transformer.
14. The K4 b
2
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 K4 b
2
.
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 K4 b
adjacent or stacked use is necessary, the K4 b
2
should not be used adjacent to or stacked with other equipment. If
2
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
ON
Protective earth ground
Chapter 1 - Getting started - 15
Alternating current
16 - K4 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
rd
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 - 17
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.
18 - K4 b2 User Manual
EMC
Guidance and manufacturer’s declaration - electromagnetic emissions
The K4 b2 is intended for use in the electromagnetic environment specified below. The customer
or the user of the K4 b
2
should assure that it is used in such an environment.
Emissions test Compliance Electromagnetic environment - guidance
RF emissions
CISPR 11
Group 1
The K4 b
Therefore, its RF emissions are very low and are not
2
uses RF energy only for its internal function.
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 K4 b
including domestic establishments and those directly
connected to the public low-voltage power supply
network that supplies buildings used for domestic
purposes.
2
is suitable for use in all establishments,
Flicker Emission
IEC 61000-3-3
Guidance and manufacturer’s declaration - electromagnetic immunity
The K4 b2 is intended for use in the electromagnetic environment specified below. The customer
or the user of the K4 b
Immunity test Test level Compliance level
2
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
±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
T
(60% dip in U
5 cycles
70% U
T
(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
T
for 0.5 cycles
40% U
) for
(60% dip in U
T
5 cycles
70% U
) for
(30% dip in U
T
25 cycles
<5% UT
(>95% dip in U
)
T
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.
T
Mains power quality should
)
be that of a typical
T
commercial or hospital
T
T
environment. If the user of the
2
requires continued
K4 b
) for
T
operation during power mains
interruptions, it is
recommended that the K4 b
) for
T
be powered from an
uninterruptible power supply
or a battery.
)
T
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.
2
Chapter 1 - Getting started - 19
Guidance and manufacturer’s declaration - electromagnetic immunity
The K4 b2 is intended for use in the electromagnetic environment specified below. The customer
or the user of the K4 b
Immunity test Test level
Conducted RF
IEC 61000-4-6
Radiated RF
IEC 61000-4-3
2
should assure that it is used in such an environment.
3 Veff
150 kHz to
80 MHz
3 V/m
80 MHz to
2.5 GHz
Compliance
level
3 V
3 V/m
Electromagnetic environment -
Portable and mobile RF communications
equipment should be used no closer to
any part of the K4 b
than the recommended separation
distance calculated from the equation
applicable to the frequency of the
transmitter
Recommended separation distance
d=1.17
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:
guidance
2
, including cables,
P
P 80 MHz to 800 MHz
P 800 MHz to 2.5 GHz
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 K4 b
the applicable RF compliance level above, the K4 b
operation. If abnormal performance is observed, additional measures may be necessary, such
as reorienting or relocating the K4 b
b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
2
.
2
should be observed to verify normal
2
is used exceeds
20 - K4 b2 User Manual
Recommended separation distances between portable and mobile RF communications
equipment and the K4 b
The K4 b2 is intended for use in an environment in which radiated RF disturbances are controlled.
The customer or the user of the K4 b
2
can help prevent electromagnetic interference by
2
maintaining a minimum distance between portable and mobile RF communications equipment
(transmitters) and the K4 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
P
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 - 21
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
Telemetry
I-ETS 300 220, CEPT T/R 01-04
pr ETS RES 0908 (CE type conformity)
Transmission frequency and output power can be changed upon request according to the
destination country requirements.
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
FCC (only USA version)
FCC ID: SN7-K4B2T-USA (transmitter)
FCC ID: SN7-K4B2R-USA (receiver)
This device complies with Part 15 of the FCC Rules. Operation is subject to the
following two conditions: (1) this device may not cause harmful interference, and (2)
this device must accept any interference received, including interference that may cause
undesired operation.
Changes or modifications not expressly approved by the party responsible for
compliance could void the user’s authority to operate the equipment.
22 - K4 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 - 23
System overview
Portable Unit (PU)
It is fixed to the patient during the test by an anatomic
harness. The PU contains the O
and CO2 analyzers, sampling
2
pump, UHF transmitter, barometric sensors and electronics. It
is powered by the rechargeable battery fixed to the back side
of the harness.
K4 b² is also provided with a small display, the PU shows in
real time the following parameters: VT, VE, VO
, VCO2, R,
2
HR, Rf Marker, battery charge level, temperature and
barometric pressure.
USA and Japan versions have the antenna not detachable from
the portable unit.
Besides data processing and presentation, the Portable Unit
has the following functions:
• Patient data input
• Environment data input (humidity)
• Gas and turbine calibration (automatic)
• Memory functions
• Tests data management
• Data loading to a PC (via RS232)
Telemetry Data Transmission, Receiver Unit (RU)
The RU consists of a small unit connected to a PC through the
RS 232 serial port. The transmission is achieved by a
miniaturized transmitter module located inside the Portable
Unit.
Battery Charger Unit (CU)
The CU allows the simultaneously charge of the 3 Ni-Cd
batteries and to supply the PU during the warm up time.
24 - K4 b2 User Manual
Flowmeter
Gas analysers
PC Software
The system uses a bi-directional digital turbine. It opposes a very low resistance to flow
(<0,7 cmH
O/l/s to 12 l/s). The air passing through the helical conveyors, takes a spiral
2
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.
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 K4 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 PC software, running on Windows™, allows the user to manage data stored in the
Portable Unit or transmitted to PC. Here following a list of the main features available:
• Test data management.
• Viewing data in table and graphic form
• Automatic and manual detection of anaerobic threshold (modified V-slope
method).
• On-line data presentation during tests.
• Advanced data elaboration (filtering, smoothing, built in spread-sheet features).
Kinetics (O2 deficit, O2 debt and time constant in both rising and falling edge of
• O
2
a constant load exercise test).
• Flow-Volume loops during the test and overlapped on the rest FVC.
• Real time display of the O
and CO2 waveforms during the test.
2
• Control of any ergometer provided with a RS232 interface.
• Custom fittings (linear and exponential).
• Spirometry (FVC, VC, IVC, MVV).
• File exporting in three different formats (Lotus 123™, Excel™, ASCII).
• Automatic detection of the "Steady State".
• Adding parameters and predicted equations trough the "Formula Editor" tool-kit.
• DDE with Microsoft Excel.
• Customizing software environments (colours, printed parameters...).
• Help on line.
Chapter 1 - Getting started - 25
Before starting
Before operating the K4 b2 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.
Note:
a: Non telemetric version
b: Internat. telemetric version
c: USA telemetric version
Code Qty Description
(version) a b c d (see note by side)
C00950-01-04 1 K4 b2 Portable Unit
C00952-01-04 1 K4 b2 Portable Unit
C00952-02-04 1 K4 b2 Portable Unit
C00949-01-04 1 K4 b2 Portable Unit
C01599-01-04 1 1 K4 b2 Receiver Unit
C01599-02-04 1 K4 b2 Receiver Unit
C00260-01-04 1 1 1 1 K4 b2 Battery Charger Unit
C01570-01-06 1 Antenna
C00342-01-12 1 Antenna cable
C02120-01-05 2 2 2 2 Turbine Ø 28mm
C02200-01-11 1 1 1 1 Kit optoelectronic reader K4 b2
A 800 900 001 2 2 2 2 Head cap for the adult masks
C02210-01-08 1 1 1 1 Permapure L73cm
C02910-01-10 1 1 1 1 Mask mouth/nose breath adult S
C02911-01-10 1 1 1 1 Mask mouth/nose breath adult M
C02912-01-10 1 1 1 1 Mask mouth/nose breath adult L
A 661 200 001 1 1 1 1 HR elastic belt
A 661 200 002 1 1 1 1 HR polar transmitter
A 182 320 001 2 2 2 2 Anti moisture filter
C01460-01-06 1 1 1 1 RH/TA probe
A 362 060 001 1 1 1 1 Power cord Schuko 2m
C01507-01-12 1 1 1 1 RS232 cable K4 b2
C00659-01-12 1 1 1 1 Cigar light adapter
A 410 110 002 4 4 4 Battery size AA 1,5V
C02100-01-06 3 3 3 Battery pack TX K4 b2
C02100-02-06 3 Battery pack TX K4 b2
C00341-01-12 2 2 1 1 Cable power supply BNCxRF
C01577-01-12 1 1 1 Cable power supply RX unit
C01929-01-08 1 1 1 1 Harness K4 b2 adult
C01143-01-98 1 1 1 1 Velcro strips (set 8 pieces)
C01800-01-05 1 1 1 1 Kit gas calibration
C01509-01-30 1 1 1 1 Carrying case
C01588-01-20 1 1 1 1 Holder Portable Unit
A 680 023 500 2 2 2 2 Time lag fuses 5x20 250V T500mA
A 680 013 630 2 2 2 2 Time lag fuses 5x20 250V T630mA
A 680 044 500 1 1 1 1 Fuses 6,3x32 250V F5A
C01790-01-36 1 1 1 1 PC software
C01999-02-DC 1 1 1 1 Conformity declaration
C00067-02-94 1 1 1 1 Registration card
C01508-02-91 1 1 1 1 K4 b2 User Manual
26 - K4 b2 User Manual
Warranty registration
Before using the system, please take a moment to fill in the registration form and the
warranty and return them to COSMED, by doing this you are eligible to the customers
assistance service.
For further information, please refer to the enclosed registration and warranty form. If
the form is not enclosed in the packaging, please contact directly COSMED.
Register the product via software
Together with the PC software, a registration software is supplied. With this software it
is possible to fill in an electronic form with the customer information.
1. To run the software, double click on the icon Registration or select Registration…
from ? menu.
2. Type the requested information and click Send… to send the form via e-mail to
COSMED.
How to contact COSMED
For any information you may need, please contact the manufacturer directly at the
following address:
COSMED S.r.l.
Via dei Piani di Monte Savello, 37
P.O. Box n. 3
00040 - Pavona di Albano
Rome - ITALY
Voice: +39 (06) 931.5492
Fax: +39 (06) 931.4580
email: customersupport@cosmed.it
Internet: http: //www.cosmed.it
Complain, feedback and suggestions
If you have any complain, feedback information or suggestion, please inform us at
complain@cosmed.it.
Chapter 1 - Getting started - 27
Options/Accessories
Accessories
Code Quantity Description
C02150-01-11 1 Adapter Spirometry kit x opto-reader 2000
Options
C00600-01-11 1 3 liters syringe for flows and volume calibration
C02115-01-10 1 Adult face mask with x Turbine 2000
C02114-01-10 1 Mask mouth/nose breath ID28 paediatric L
C02113-01-10 1 Mask mouth/nose breath ID28 paediatric S
A 800 900 004 1 Paediatric Headcap
A 800 900 017 1 Comfort seal L 10 pcs
A 800 900 018 1 Comfort seal M 10 pcs
A 800 900 019 1 Comfort seal S 10 pcs
A 800 900 020 1 Comfort seal paediatric L 10 pcs
A 800 900 021 1 Comfort seal paediatric S 10 pcs
Telemetry data transmission
The optional Telemetry data transmission allows the researcher to transmit data on line
to a PC up to a distance of 800 meters. All signals are in real time transmitted via radio
to the RU to be saved and displayed on-line to any PC.
Spirometry Kit
Optional software and accessories designed for performing screening Spirometry such
as Forced Vital Capacity, Slow Vital Capacity, Maximum Voluntary Ventilation and
broncho-challenge tests.
28 - K4 b2 User Manual
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
Chapter 1 - Getting started - 29
Technical features
Portable Unit
Memory 16,000 breaths
Display LCD 2 lines x 16 characters
Keyboard: waterproof, 6 keys
Serial Port RS 232C
Power supply: Ni-MH rechargeable batteries 3 hours endurance
Thermometer: 0-50°C
Barometer: 53-106 Kpa
Dimensions PU : 170x55x100 mm,
Dimensions battery: 120x20x80 mm
Weight: 400g
Receiver Unit
Transmission range: 800 meters
Battery: 4 x 1.5 V AA
Dimension: 170 x 48 x 90 mm
Weight: 550 g
PC interface: RS 232
Battery charger Unit
Power supply 120V - 240 V
Power consumption 25 W
Flowmeter
Type: Bidirectional digital turbine Ø 28 mm
Flow Range: 0,03-20 L/sec
Accuracy: ± 2%
Resistance: <0.7 cmH
O s/L @ 12 L/s
2
Ventilation Range: 0-300 litres x min
Oxygen Sensor (O2)
Response time: <150 ms
Range: 7-24% O
2
Accuracy: ±0.02% O2
Carbon Dioxide Sensor (CO2)
Response time: <150 ms
Range: 0-8%
Accuracy: ±0.01%
Humidity absorber
Capillary of Nafion (Permapure ®)
Power Supply
Voltage: 100V-240V ±10%; 50/60Hz
Power consumption 60W
30 - K4 b2 User Manual
Environmental Sensors
Temperature: 0-50°C
Barometer: 400-800 mmHg
Humidity: 0-100%
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
32 - K4 b2 User Manual
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%)
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
Chapter 2 - Measurements - 33
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
34 - K4 b2 User Manual
Installation
Installation sequence
Before starting operating with the system make sure to meet the environmental and
operational conditions reported in Chapter 1.
Battery Charger Unit
The Battery Charger Unit allows the following functions:
• Charge 3 rechargeable batteries simultaneously.
• Charge batteries by means of the car lighter plug.
• Supply the K4 b
2
Portable Unit directly by the main power.
Warning: Before turning the
Battery Charger Unit on, check
the voltage switch selected
Check voltage
The Battery Charger Unit is provided with a switch that allows to change the voltage
according to the following values:
• 115V 50-60 Hz (100V-120V)
• 220V 50-60 Hz (200V-240V)
To change setting, move the switch on the new voltage by using a small screwdriver or
a pen.
Turn the Unit on
1. Connect the Charger Unit to the main plug.
2. Turn on the Unit by pressing the orange power switch.
Charge the batteries
1. Insert the batteries into the places on the top of the unit as shown in the illustration
below.
2. The small green LED placed on the front panel warns the charge in progress. The
battery is charged when the light signal placed on the front panel of the Charger
Unit starts blinking.
36 - K4 b2 User Manual
Note: USA and Japan versions have not the antenna connector on the battery.
Portable Unit
Battery low
It is recommended to charge batteries before each test. When the batteries are low the
warning message is prompted on the PU by two beeps for an half charged battery and
three beeps for a complete discharged battery.
As soon as the message appears, you must change batteries immediately since the
system has only few minutes of endurance still available. The system allows to change
the battery during testing as well.
During the test, it is possible to monitor the battery status in real time by selecting
Information from View menu.
The PU can be supplied either by the Charger Unit or by rechargeable batteries. It is
recommended during Warm-up to supply it exclusively by the Charger Unit time in
order to save the battery used normally during the test.
The control panel of the Portable Unit is mainly composed by a keyboard, and 4 plugs
for power supply, turbine, antenna, heart frequency and sampling tube connections. The
following illustrations show in detail the control panel.
A Marker key
B Display
C Cancel key
D Enter key
E Scroll up/down key
F On/Off switch
Note: USA and Japan versions have the antenna not detachable from the portable unit.
Chapter 3 - Installation - 37
y
Important: In order to ensure
accurate gas measurements,
you must wait for a warming-up
time before operating the K4
b². During this period the PU
must be turned on for at least
Warning: Supply K4 b2 with
Charger Unit for warming up
.
onl
Warm up
The K4 b2 uses O2 and CO2 heated sensors. We strongly recommend at least 45 minutes
warm-up time at an ambient temperature of 20°C. More time is necessary if the
environmental temperature is lower. Calibration or testing before warm-up time is
completed, can cause wrong results.
Warming-up the unit by main power
1. Connect the Charger Unit to the main power by the AC power cable.
2. Connect the power-supply cable both in the Charger Unit and K4 b
2
as shown
below and turn both the units on.
Turning on/off the portable unit
To turn the K4 b2 on or off press the on/off key.
Connect the rechargeable battery
Plug the power supply cable into the battery socket as shown in the following
illustration.
International telemetric version USA and Japan Telemetric version
Sometimes you might need to change the battery during the test. To do this you must
change the battery in the shorter time possible. The Portable Unit does not transmit data
while it is not powered.
Warning: During testing make sure to change the battery as fast as possible, since a
long time could compromise the reliability of measurements.
38 - K4 b2 User Manual
Receiver Unit
2
Optionally the K4 b2 is provided with a transmitter board (located inside the K4 b
and a Receiver Unit to monitor "on-line" exercise tests performed either in the field or
in the lab. All data measured by the K4 b
2
are transmitted "breath by breath" to the
unit)
Receiver Unit in real time. The RU (illustrated below) must be connected to a Personal
Computer with any RS 232 serial port to display data "on-line" in the management
software. The transmission range is 800 meters in open field. However during
transmission the test is stored in the memory of the K4 b
2
Unit so that, in case of
transmission interference no data is lost.
Turning on/off the receiver unit
To turn the receiver unit on or off use the switch on the front side of the unit.
Receiver unit power supply
The K4 b2 Receiver Unit is provided with four 1.5 V AA batteries. Before turning the
unit on be sure that batteries are charged. If the status battery indicator blinks red you
must replace the 4 batteries. The unit can be also supplied by 6V DC power through the
cable provided in the equipment.
The receiver unit can be supplied by two different sources:
• by the Battery Charger Unit: connect the units by the 6V DC cable.
• by 4 AA 1,5V batteries.
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 Balance
For the calibration procedure, see the Calibration chapter.
Chapter 3 - Installation - 39
Connecting the K4 b2 to the patient
2
K4 b
is a portable system with a total weight lower than 1 kg. Cosmed has developed a
special harness to fix the unit to any subject. The harness consists of a belt that can be
adjusted to fit different sizes and positions. I.e. if you need to test cyclist or rower
athletes we recommend to locate both units (K4 b
subject to increase comfort and to avoid any obstacles during movements. For this
reasons plates are provided with the harness and they can be easily removed and placed
in different positions.
Assemble the mask and the flowmeter
K4 b² is provided with a turbine flowmeter that can be easily disassembled for allowing
cleaning and disinfection.
1. Plug the turbine in the mask adapter by pushing and rotating it clock-wise till you
feel a stop.
2. Insert the optoelectronic reader over the turbine and press it till the mask.
3. Plug the wind cover as described in point 1.
4. Plug the sampling tube in the little hole located in the optoelectronic-electronic
reader.
5. Plug the turbine cable in the Turbine plug control panel of the K4 b
2
and battery) on the back of the
2
.
Notice: In order to preserve
items composing the mask, it's
recommended to grease
periodically O-rings in the
optoelectronic reader with
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
40 - K4 b2 User Manual
Apply the seal to the mask
Apply seal to clean, residue-free mask only and follow the instructions below:
1. Remove the plastic tray from the bag. Peel off clear film and retain for later use.
2. While holding tray align the nose area of mask to nose area of Ultimate Seal™ gel.
Press together and roll mask down over the surface of the gel seal attaching it to the
mask and releasing it from the tray.
3. If needed, adjust the position of the seal, aligning it with the outer perimeter of the
mask sealing surface.
4. The mask is now ready to be placed on the subject's face.
To remove seal on mask
• The Ultimate Seal™ have been conceived for a single patient use only, it can not be
cleaned or sterilised.
• If mask requires cleaning for a new patient application then pull off and dispose of
the Ultimate Seal™.
• To keep the seal clean between use, keep it attached to the mask and place the clear
film against the Ultimate Seal™ gel on the mask. When the seal becomes
Notice: Avoid the exposure
to the sun. Do not put the
seal into the water.
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.
Chapter 3 - Installation - 41
quip
Fixing the K4 b2 to the patient
1. Fix the heart belt to the patient’s box thorax.
2. Fix the K4 b
on the back .
3. Connect the battery cable to the 6V plug of the K4 b
red plug, that repairs the plug from water or sweat drops, is on the Portable Unit
side.
4. Connect the antenna cable to the Antenna plug of Portable Unit control panel.
5. Insert the heart frequency receiver and temperature probe cable in the HR-Temp
plug placed on the control panel.
6. Insert the male connector of the turbine in the Turbine plug on the control panel.
7. Fix the power supply cables, antenna and turbine on the right side of the jacket with
the velcro stripes provided in the equipment. Fix the heart frequency probe on the
left side.
Notice: Be sure to fix the
Heart rate probe on the left
side, while the other cables
have to be fixed on the right
side. This must be done for
avoiding interferences
2
unit to the front of the harness. Do the same operation with the battery
2
control panel. Be sure that the
Notice: Fix all cables with
the velcro strips provided
with the e
ment.
Note: USA and Japan versions differ from the picture because of the antenna
placement.
42 - K4 b2 User Manual
Connecting the K4 b2 to the PC
K4 b2 can be connected to any PC provided with serial port in order to monitor "online" physiological data during any kind of activity.
Connect the Portable Unit to the PC
Connect the K4 b2 Portable Unit to a serial port available in the PC. Be sure to set the
2
K4 b
software to the proper serial port for the transmission.
Connect the Receiver Unit to the PC
Connect the telemetry module to a serial port available in the PC. Be sure to set the K4
2
b
software to the proper serial port for the transmission.
Chapter 3 - Installation - 43
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.
44 - K4 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 K4 b2 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 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…
from ? menu.
Chapter 3 - Installation - 45
46 - K4 b2 User Manual
Calibration
Gas calibration procedures
The system can be calibrated according to the following procedures:
1. Room air calibration
2. Reference gas calibration
3. Delay calibration
4. Turbine calibration
The Room air calibration, forced by the system before every test, consists of a sampling
room air. It updates the baseline of the CO
order to match the readings with the predicted athmospheric values (20.93% for O
0.03% for CO
The Reference gas calibration, recommended to be carried out daily, consists of
sampling a gas with a known composition (i.e. 16.00% for O
a calibration cylinder, and updating the baseline and the gain (span) of the analyzers in
order to match the readings with the predicted values (i.e. 16.00% for O
CO
).
2
The Delay calibration, recommended to be carried out ones a week or whenever the
sampling line is replaced, is necessary to measure accurately the time necessary for the
gas sample to pass through the sampling line before being analyzed.
The Turbine calibration, recommended to be carried out quarterly, consists in measuring
the volume of a 3 litres calibration syringe and in updating the gain of the flowmeter in
order to match the predicted value.
).
2
analyzer and the gain of the O2 analyzer, in
2
and 5.00% for CO2) from
2
and 5.00% for
2
and
2
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
2
syringe (i.e. 3 litres).
Set the reference values using the PC software
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
20.93%), and do the same for the gas concentration of the calibration cylinder.
and 0.03%
2
and CO2 room air concentration (i.e. 2093 for
2
48 - K4 b2 User Manual
3. Type the volume of the calibration syringe (i.e. 3000 for a 3 litres calibration
syringe).
4. Press OK button to confirm changes.
Room air calibration
p
Note: After turning on the
unit, wait 45 minutes warm
up time before starting the
calibration
rocedure.
Important: During
calibration always remove
the sampling tube from the
optoelectronic reader. Do
not remove the sampling
tube from the Portable Unit
otherwise calibration could
Caution: During Room Air
calibration be sure to put the
sampling line far from the
expired gas otherwise
Set the reference values using the Portable Unit
To set reference values from the K4 b2 Portable Unit go to the main menu, choose
Calibration and scroll tasks up to choose Set Cal. Predicted Values, type the values
using the arrow keys and press Enter to confirm changes.
Room Air calibration is forced to be performed before each test. With this procedure the
system calibrates both gas analyzers according to the Room Air Concentrations
(20.95% O
and 0.03% for CO2). You can run this procedure either with the software or
2
directly with the Portable Unit.
Room air calibration using the PC software
1. Connect the Portable Unit to the PC by the serial port. Remove the sampling plug
from the flowmeter.
2. Run the calibration program and choose Room air from the Calibration menu.
3. The message "Room air calibration in progress..." will appear and a graph will
show in real time the O
and CO2 calibration. At the end of the manoeuvre the
2
message "Calibration done" will be visualized.
4. The following dialogue box will appear showing the calibration results, press OK
to confirm the calibration.
Caution: Room Air calibration
performed in small ambients
(high concentration of CO
affects the calibration results
and the accuracy of the
)
2
Room air calibration using the Portable Unit
1. Remove the sampling plug from the flowmeter.
2. In the main menu choose Calibration menu, choose Room Air Calibration and
confirm by pressing Enter.
3. The procedure is automatically performed until the message "Calibration done"
appears, the O
and CO2 values will be visualized on the display.
2
4. Exit the Calibration menu by pressing Enter or Cancel.
Chapter 4 - Calibration - 49
oxygen senso
gas are properly entered
g
gas are properly entered
Reference gas calibration
The software allows to automatically calibrate zero, gain and alignments of the gases
Notice: Do not use mixtures
with a O
24% since it is out of the
concentration above
2
r range
Notice: Before calibrating be
sure the "Reference values"
of room air and reference
Caution: Be sure that the
cylinder pressure out is
ulated to 3 and 5 bar.
re
sensors. Even if the program doesn't force you to carry out the calibration, the system
should be calibrated before each test. To perform the sensor calibration is necessary to
have available a cylinder filled of a concentration known of mixed gas. It is suggested
to use CO
The calibration unit
The gas regulator has an adjustable second stage that must be open every time the
cylinder is used for the calibration. This is necessary to avoid a small leakage in the
connections can discharge the bottle in few time.
1. Make sure you wait for warm-up time before starting calibrating. Be sure the high-
.
pressure tube supplied together with the system is connected to the "Cylinder" plug.
2. Open the cylinder valve by turning the valve counter-clockwise, the pressure value
must be set within a range of 300-500 Kpa (3-5 bars or 44-73 Psi).
Notice: If the pressure
regulator is set at a different
pressure from what
specified, room air could be
mixed together with
reference gas and the
5,00% , O2 16% concentrations and N2 for balance.
2
Notice: Before calibrating be
sure the "Reference values"
of room air and reference
.
50 - K4 b2 User Manual
After these operation, please operate as follows.
Reference gas calibration using the PC software
1. Connect the K4 b2 unit to the PC by the serial port. Remove the sampling plug from
the optoelectronic reader.
2. Run the calibration program and choose Gas from the Calibration menu.
3. The message "Gas calibration in progress..." will appear and a graph will show in
real time the O
and CO2 calibration. The software runs first the Room Air
2
calibration, so do not connect the sample plug to the calibration kit until the
message "Sample reference gas..." will be displayed. At the end of the procedure
the message "Calibration done" will be visualized.
4. The dialogue box showing the calibration results will appear, press OK to confirm
the calibration.
5. Remove the sampling line from the kit and close the cylinder.
Reference gas calibration using the Portable Unit
1. Remove the sampling plug from the flowmeter.
2. In the main menu choose Calibration menu, choose Refernce gas calibration and
confirm by pressing Enter.
2
3. The K4 b
runs first the Room Air calibration, so do not connect the sample plug to
cylinder output until the message " Sample reference gas..." will be displayed. At
the end of the procedure the message "Calibration done" will be visualized.
Chapter 4 - Calibration - 51
4. Exit the Calibration menu by pressing Enter or Cancel.
5. Remove the sampling line from the kit and close the cylinder.
Gas delay calibration
The delay calibration procedure is a calibration included in the software due the time
alignment between flow and gas concentration measurements is one of the potential
problems to consider to assure accurate readings during test. The gas delay calibration is
the measurement of time required by the gas to reach the gas analyzer.
For "breath by breath" analysis it is essential that the instantaneous flow rate must be
multiplied by the proper time-matched expired gas concentration. Although flow can be
instantaneously measured, gas concentration measurements can be calculated with a
delay related both to the time necessary for the gas to be transported to the sensor and to
intrinsic characteristics of the analyzer principle.
Two factors contribute to the time alignments delay. K4 b
tube with a pump to draw a continuous gas sample into the analyzers. The gas transport
time depends on the dimensions of the tube and on the pump flow rate. Additionally the
gas sensors have a response time that must be added to the above delay for calculating
the total delay.
The software of the K4 b
and introduces a correction to realign both flow and gas measurements.
This procedure must be carried out each time some changes occur in the sampling
system, i.e. when the sampling tube is changed. However it is recommended to carry
out this calibration each week in order to prevent wrongs measurements.
Delay calibration using the PC software
1. Connect the K4 b2 unit to the PC by the serial port. Remove the sampling plug from
2. Run the calibration program and choose Delay from the Calibration menu.
2
by carrying out the Gas Delay procedure calculates this delay
the optoelectronic reader.
2
uses a capillary sampling
52 - K4 b2 User Manual
3. The message "Gas calibration in progress..." will appear and a graph will show in
real time the O
and CO2 calibration. The software first runs the Room Air
2
calibration. At the end of the Room Air calibration the following message appears.
4. Connect the sampling tube to the optoelectronic reader and press OK button to start
breathing at a constant rate.
5. Synchronise the breath (inspiration and exhalation) with the acoustic signal..
6. Continue breathing some cycles until the message "Calibration done" appears. The
software open a dialogue box with the new calibration factors and the new delay
value. Press OK to confirm the calibration.
Delay calibration using the Portable Unit
1. On the main menu scroll the commands, choose Calibration and press Enter to
confirm the choice.
2. Choose O
/CO2 delay calibration and press Enter to confirm.
2
3. The following message appears, and the software automatically run the Room air
Calibration.
4. When the message “Connect the sampling line and press Enter” appears press
Enter and start breathing at a constant rate. Synchronise the breath (inspiration and
exhalation) with the acoustic signal.
5. After some cycles a message will appear confirming the delay calibration and the
new values will be shown on the display. Press Cancel to return to the previous
menu.
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.
Chapter 4 - Calibration - 53
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
2
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.
Please select on the portable unit 1.Settings/8.Turbine 18/28 and set Turbine 28.
If the calibration is performed through the PC, in the calibration program, select
File/Turbine results..., in the field Type (mm) must be entered 28.
54 - K4 b2 User Manual
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.
1. Syringe
2. Silicone tube
3. Adaptor for calibration syringe.
Note: If you are using a slow
PC, we recommend to set
an higher refresh time.
Note: If a bacterial filter is used for the tests, do use it also during the turbine
calibration.
Calibrating the turbine
Turbine calibration using the PC software
After having run the calibration program:
1. Select Reference Values from the File menu. If your syringe has a different value
from the default one (3 litres), please enter the correct value.
2. Select Calibration/Turbine….
3. When the Calibration Turbine dialog box appears with the syringe piston initially
pushed all the way in, move the piston in and out for 5 inspiratory strokes and 5
expiratory strokes in order to get the first values appearing on the display. Then
move the syringe piston for other 10 strokes (IN and EX).
4. 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.
Chapter 4 - Calibration - 55
Turbine calibration using the Portable Unit
1. Screw up the adapter for the calibration syringe to the optoelectronic reader.
2. Connect the optoelectronic reader to the calibration syringe. Before starting the
calibration be sure to have inserted the right reference value for the syringe. To
check it, select Volume Syringe from the Set predicted value menu.
3. Then choose Calibration from the main menu and press Enter.
4. Scroll the menu, choose Turbine Calibration and press Enter.
5. Start moving the syringe till the message "Operate syringe" will disappear on the
display. The display will show expired (E) and inspired (I) readings for each stroke.
6. When the display visualizes the message "Calibration done" the Turbine has been
calibrated, press Cancel to return to the main menu, the new calibration factor will
be automatically stored.
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.
Please select on the portable unit 1.Settings/8.Turbine 18/28 and set Turbine 18.
If the calibration is performed through the PC, in the calibration program, select
File/Turbine results..., and enter 18 in the field Type (mm).
56 - K4 b2 User Manual
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 - 57
r
r
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 K4 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).
2
.
Using the control panel
mV / real values
display
edit parameters
(name, unit,…)
Flowmete
on/off
Buzzer
Sampling
pump on/off
on/off
Transmitte
on/off
Select all
channels
Deselect all
channels
Digital CO
trimmer
Signal refresh
time
2
58 - K4 b2 User Manual
Operating modes
K4 b2 Operating modes
K4 b2 is a versatile system. You can use it in the field or in the lab without any kind of
limitation. Test can be carried out in the following three different configuration:
• Holter Data Recorder
• Telemetry Data Transmission
• Laboratory Station
Holter Data Recorder
Using the system in the field without the Receiver unit you can store data "breath by
breath" in high capacity memory (1 MB). The memory allows to store up to 16
thousands breaths, when the test is completed, the results can be downloaded to the PC
via the RS 232 port provided with the equipment.
Telemetry Data Transmission (option)
In case the telemetry Data Transmission module is available, the K4 b2 portable unit
provided with a small transmitter that allows to send data by telemetry up to a distance
of 800 meters. All data are transmitted "breath by breath" to the receiver unit. The
Receiver Unit must be connected to a PC by serial port, it allows the resercher to
monitor data on line both in table and graphic format. Anyway tests are stored in the
memory of the portable unit, thus in case of transmission interferences no data are lost.
By using the system with a PC the software K4 b
ergometers by using user defined exercise protocol.
2
can also control and synchronise
Serial (Laboratory) Station
Although K4 b2 has been designed for tests in the field, it can also be used as a
conventional laboratory station as it offers the same features of the best stand alone
devices. Under this operating mode the K4 b
PC through the RS232 serial port and all tasks, exactly like any conventional laboratory
device. Anyway tests are stored on the memory of the portable unit as well.
2
Portable Unit is simply connected to the
60 - K4 b2 User Manual
W
y
w
Portable Unit User Interface diagram
Settings
On/Off
Transmitter
Enable/Disable
Warnings
Set Date and
Time
Units of
Measurement
Restore Factory
Settings
arm up time
Setting
Memory
functions
Memor
Status
Vie
Test list
Erase
Memory
Test Calibration
Patient’s
Data
Start
Test
Room Air
Calibration
Reference Gas
Calibration
Turbine
Calibration
O2/CO2Delay
Calibration
Set Calibr.
Pred. Values
Set Calibr.
Factors
External
Device
Turbine
18/28
Altitude
Setting
Version
Control
Panel
GPS
Autolocate
Chapter 5 - Operating modes - 61
Holter Data Recorder Mode
Note: USA and Japan
versions have the items 3
and 5 slightly different
because of the antenna
It is ideal operating modes if you need to test a patient difficult to monitor by Telemetry
(i.e. climbing, long distances races, etc). The memory capacity of the K4 b
2
is able to
store data up to 16 thousands breaths. The system saves data for each breath, hence time
storing capacity depends on the respiratory frequency.
1. Mask + flowmeter
2. Heart rate belt
3. Rechargeable battery
4. Harness
5. K4 b
2
Unit
6. HR probe
7. Power cable
Operating sequence
Warming-up the system
Warm-up the K4 b
Enter new patient
1. Connect K4 b
2. Go to the K4 b
2
for 45 minutes before testing or calibrating.
2
to the subject.
2
control panel and choose Patient's data from Test menu.
3. Move the cursor among fields with the Enter key and use the Up and Down keys
to modify values.
The fields are shown in the following order:
#: patient ID
A: age in years
H: height (cm or inch)
W: weight (kg or Lbs)
S: sex (M or F)
HR: HR max
4. The HR Max is automatically calculated by the formula 220-age, however it can be
also changed according to physician experience and patient medical history. By
confirming the HR rate value all the patient data are automatically saved.
62 - K4 b2 User Manual
Calibrate and start the test
1. Remove the sampling plug from the mask and put the tube far from expired gas
concentrations.
2. On the Patient's Data menu scroll down the menu and select Start Test from the
main menu and press Enter to confirm.
3. The message "Insert relative humidity" will be visualized, type the correct value
and press Enter.
2
4. The K4 b
runs automatically the Room Air calibration. The message "Do not
breath near the sampling line" appears. Wait for few seconds until the message
"Calibration done" will appear together with a double beep sound.
5. Connect the sampling plug to the optoelectronic reader. Some values (Heart Rate,
R, VO
, VCO2,...) will be shown and updated each breath on the control panel
2
display. The message "Press Enter to start the test" will be displayed each 10 secs.
You can switch to different values by moving the Up and Down key.
6. After having pressed the Enter key the test starts but the K4b2 is not storing data.
In this phase the PU is checking the main parameters and you can visualize it on the
PU display by the time is blinking.
7. To start storing data press another time the Enter key. You can check the storing
phase because the time parameter don't blink anymore.
Stop the test
To stop the test press Cancel. The message "Press enter to stop test" will appear, press
Enter to stop the test.
Transferring test to PC
Once the test is concluded you may download all data stored in the K4 b2 to the
management software.
1. Turn the K4 b
2. Connect the K4 b
3. Run the K4 b
2
on.
2
to the PC by the serial cable enclosed in the equipment.
2
software and choose Receive Test from the Test menu.
4. To download a test you must link it to an existing patient file. Choose Find and
then List to select an existing patient. If the patient is new than select Find and then
New, fill in the fields and press OK to confirm.
5. Select the test to link by using First, Previous, Next and Last buttons and press
Download to confirm your choice and to store the test on the Hard Disk. You can
use the Preview button to see some data and graph of the test in order to find out
the proper one.
Chapter 5 - Operating modes - 63
Telemetry Data Transmission Mode
Note: USA and Japan
versions have the items 3
and 5 slightly different
because of the antenna
In case you need to monitor in real time the test you can use the Telemetry Data
Transmission module that is provided by COSMED as an option. The transmission
range can reach 800 m allowing to monitor exercise testing in the field. To use this
option you need a personal computer to connect the receiver unit.
1. Mask + flowmeter
2. Heart rate belt
3. Rechargeable battery + antenna
4. Harness
5. K4 b
2
Unit
6. HR probe
7. Power cable + antenna
8. Receiver unit
9. RS232 cable
10. Personal computer
Operating sequence
Warming-up the system
Warm-up the K4 b
Connect the receiver unit to the PC
2
for 45 minutes before testing or calibrating.
Connect the receiver unit to PC with the serial cable provided in the standard packaging.
Enable transmission
1. Go to the K4 b2 control panel, verify that transmission is enabled by choosing
Settings /On/Off Transmitter and press Enter.
2. Enable the transmission by moving the "*" sign on Transmit. On and press Enter
to confirm settings.
Enter new patient
1. Connect K4 b2 to the subject.
2. Go to the K4 b
2
control panel and choose Patient's data from Test menu.
3. Move the cursor among fields with the Enter key and use the Up and Down keys
to modify values.
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The fields are shown in the following order:
#: patient ID
A: age in years
H: height (cm or inch)
W: weight (kg or Lbs)
S: sex (M or F)
HR: HR max
4. The HR Max is automatically calculated by the formula 220-age, however it can be
also changed according to physician experience and patient medical history. By
confirming the HR rate value all the patient data are automatically saved.
Enable reception on PC
1. Run K4 b2 software.
2. Open patient data dialog box, select or type a new name and press OK to confirm.
The name of the selected patient will appear in the status bar of the software.
3. Choose Execute test from the Test menu.
4. Type the patient information, select a protocol from the list and an ergometer if
you are going to carry out a test with an ergometer.
5. Chose Other Data if you want to insert other important informationon the the you
are going to perform.
6. Select the workspace you would like to see during the test (it can be also changed
during test), check the option box Telemetry to enable software receiving of data
and press OK to confirm. The software will show blank windows waiting for the
first breath.
Calibrate and start the test
1. Remove the sampling plug from the mask and put the tube far from expired gas
concentrations.
2. On the Patient's Data menu scroll down the menu and select Start Test from the
main menu and press Enter to confirm..
3. The message "Insert relative humidity" will be visualized, type the correct value
and press Enter.
2
4. The K4 b
runs automatically the Room Air calibration. The message "Do not
breath near the sampling line" appears. Wait for few seconds until the message
"Calibration done" will appear together with a double beep sound.
Chapter 5 - Operating modes - 65
5. Connect the sampling plug to the optoelectronic reader. Some values (Heart Rate,
R, VO
, VCO2,...) will be shown and updated each breath on the control panel
2
display. The message "Press Enter to start the test" will be displayed each 10 secs.
You can switch to different values by moving the Up and Down key.
6. After having pressed the Enter key the test starts but the K4b2 is not storing data.
In this phase the PU is checking the main parameters and you can visualize it on the
PU display by the time is blinking.
7. To start storing data press another time the Enter key. You can check the storing
phase because the time parameter don't blink anymore.
Stop the test
To stop the test press Cancel. The message "Press enter to stop test" will appear, press
Enter to stop the test.
Transferring test to PC
If some interferences should occur during test execution by telemetry, some breaths
could be lost. The software shows a message on the status bar warning that some steps
missed . Since K4 b
2
stores every time the complete test in the memory, it is possible to
download the test later to the management software to recover all lost data.
1. Turn the K4 b
2. Connect the K4 b
3. Run the K4 b
2
on.
2
to the PC by the serial cable enclosed in the equipment.
2
software and choose Receive Test from the Test menu.
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4. To download a test you must link it to an existing patient file. Choose Find and
then List to select an existing patient. If the patient is new than select Find and then
New, fill in the fields and press OK to confirm.
5. Select the test to link by using First, Previous, Next and Last buttons and press
Download to confirm your choice and to store the test on the Hard Disk. You can
use the Preview button to see some data and graph of the test in order to find out
the proper one.
Serial Mode
Note: USA and Japan
versions have the items 3
and 5 slightly different
because of the antenna
Operating sequence
When the K4 b2 is used in the serial mode the system works exactly as any other
conventional laboratory station. In this mode the software controls completely the K4 b
portable unit so that any command such as calibration can be run by the software. You
can also drive an ergometer if a second serial port is available in the PC.
1. Mask + flowmeter
2. Heart rate belt
3. Rechargeable battery
4. Harness
5. K4 b
2
Unit
6. HR probe
7. Power cable
8. Receiver unit
9. RS232 cable
10. Personal computer
2
Warming-up the system
Warm-up the K4 b
Connect the Portable unit to the PC
2
for 45 minutes before testing or calibrating.
1. Connect K4 b2 to the PC by the serial cable
2. Check that the Serial Port is properly selected by choosing RS 232 from the Option
menu.
3. Check the Ergometer connected to PC option box if you intend to use an
ergometer for testing.
Calibrate the system
1. Run the K4 b2 software and choose Calibration from the Test menu.
2. In the Calibration software select Analyzers -> Room Air from the Calibration
menu.
Enter patient data
1. In the K4 b2 software and choose Patient from the File menu.
2. Select a patient from the list or press New to enter a new name and press OK to
confirm.
Chapter 5 - Operating modes - 67
Start the test
1. Open patient data dialogue box, select or type a new name and press OK to
confirm. The name of the selected patient will appear in the status bar of the
software.
2. Choose Execute test from the Test menu.
3. Type the patient information, select a protocol from the list and an ergometer if
you are going to carry out a test with an ergometer.
4. Chose Other Data if you want to insert other important informationon the the you
are going to perform.
5. Select the workspace you would like to see during the test (it can be also changed
during test) and be sure that option box Telemetry is disabled since the
transmission will be done by serial cable. Press OK button to start acquisition.
6. The software displays the data according to the selected workspace. Check some
breaths and press F2 to start testing.
Stop the test
To end the test press F3, press OK in the following dialogue box to confirm the end of
the test. All data will be automatically saved on the Hard disk. Anyway test is stored on
the memory of the portable unit as well.
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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.
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Uploading tests from the Portable Unit
In telemetry and holter function you could need to upload data from the portable unit
via serial port.
1. Link up the PU to the PC with the RS232 cable supplied.
2. Turn on the Portable Unit.
3. Choose Receive Test from Test menu or press Alt F2.
4. To be downloaded the test must be linked to a patient. If the current patient has
already been inserted in the database, choose Find and then List select the patient
and confirm. If the current patient doesn't belong to the archive he must be inserted,
select Find and then New, fill in the fields and confirm. Now the download
function is available and the test will be filed on the PC.
5. Choose the test to link with the First, Previous, Next and Last buttons and press
Download.
6. A status bar will show the data acquisition in progress. At the end a message will
indicate the end of data reception.
Chapter 6 - Database Management - 71
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 6 - Database Management - 73
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 6 - Database Management - 75
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Exercise testing
Recommendations for the exercise testing
The evaluation of the cardiorespiratory function
The physical training requires the interaction of physiological mechanisms that allow
the cardiovascular and respiratory systems to supply the increasing demand of energy
due to the contraction of the muscles.
During the training the systems are both engaged, an adequate answer to the effort is the
measure of theirs health state.
The increase of the metabolic rate, during the exercise, needs an appropriate increase of
oxygen in the muscles. At the same time, the 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
2
Ending the test
The patient should be monitored with ECG for at least 8 minutes, in resting conditions
or until he returns to the pre-exercise conditions.
Preparing the patient
To enhance the value of a diagnostic test it’s very important patient collaboration. In
most cases a well-informed patient will make a better effort (in relation to his
conditions) and will allow a reliable interpretation of the test. For this reason every
ergometric test must be preceded from a precise training of the patient.
Before testing
The physician applying the exam must be provided with a written request including a
brief description of the diagnosis (confirmed or suspected ), the request’s reason and the
patient therapy carried out showing the dose and time of the drug assumption.
To standardise the response to the test and reduce the patient’s anxiety it’s suggested to
provide him either written (before the exam) or oral (at the same time of the test)
information. At the scheduling time detailed instructions should be delivered to the
patient, consisting in smoke and food abstinence three hours before an ergometric test,
or eight hours before a scintigraphic test.
Test are usually executed supporting the therapeutic outline in progress, but sometimes
it could be necessary to stop some drugs, such as b-block or calcium antagonist, which
could impair the effort response reducing the diagnostic accuracy of the exam.
The patient must wear comfortable suit and gymnastic shoes and two hours before test
stop any kind of drugs, eat light and avoid coffee and smoke.
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It’s very important acquire information on the patient’s clinical past before performing
the test. Keep attention in particular way to the use of drugs, tobacco, to the physical
fitness and symptoms produced with the exercise.
Patient assent
The patient is informed that he will be submitted to a maximum effort, which could be
stopped at any moment, and of the risks of the test execution.
Ending the test
Test may end when the maximum value of the oxygen consumption has been reached
and the patient’s response established.
Chapter 7 - Exercise Testing - 79
Real time test
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
Start the test as described in the chapter Operating modes. If you use the device in
Holter mode, please skip this until Data management. The following is applicable only
to tests performed with the PC (telemetry or serial mode).
The software environment will change showing a new Menu bar and toolbar while the
first data will be displayed in a table format.
At this point the software starts showing data on the monitor but without saving them,
this in order to monitor the patient before starting the test. To start storing data press F2.
Abort the test without saving data
Choose Abort from the Test menu or press Alt+F3.
End the test saving data
1. 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.
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.
Parameters to view
While the test is running, it is possible to choose the parameters to view.
1. Select Parameters to view/Test execution… from the Options menu.
2. Select the parameters and confirm.
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Manual protocol
the labe
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 K4 b2 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".
Chapter 7 - Exercise Testing - 81
Data management
As soon as the test has been completed or downloaded, 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.
82 - K4 b2 User Manual
p
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.
Chapter 7 - Exercise Testing - 83
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.
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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.
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).
2
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.
Chapter 7 - Exercise Testing - 85
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
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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
It is possible to print graphs and data by means of two functions: Print report and
Print current window. The last one is active only if the active window is a graph or a
data report.
Chapter 7 - Exercise Testing - 87
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.
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Data Editing
g
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.
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.
Chapter 7 - Exercise Testing - 89
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:
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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.
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.
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.
Chapter 7 - Exercise Testing - 91
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.
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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 K4
2
b
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
.
in
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.
Chapter 7 - Exercise Testing - 93
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.
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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
2
threshold (%) and R threshold.
The steps which satisfy these conditions will be highlighted with a yellow bar.
Chapter 7 - Exercise Testing - 95
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.
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Select parameters to be printed
K4 b2 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.
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.
Chapter 7 - Exercise Testing - 97
Events management during exercise testing
By using K4 b2 in serial mode, beside standard measurements, the software allows also
to save some extra "events". They are so called "events" since they are not continuously
stored during the test but they can be saved upon user selection.
Flow Volume loops
This test is useful during exercise to detect abnormalities in the mechanics of ventilation
in patients with pulmonary/ventilatory limitations to exercise.
The test consists in acquiring some flow/volume loops during exercise at different
workloads and overlapping them on the rest maximal flow/volume loop of a Forced
Vital Capacity test.
The majors information that you can get from this manoeuvres are the flow reserve
(flow distance from the peak flow of the F/V loop during exercise to the corresponding
flow on the superimposed F/V loop at rest) and the volume reserve (volume distance
from the maximum volume of the F/V loop during exercise to the corresponding
volume on the superimposed F/V loop at rest).
The manoeuvre consists in the following phases:
• Acquiring some Flow/Volume loops during the exercise
• Making the patient inspire completely up to TLC level (this is necessary to place
the loop correctly into the rest F\V loop of the forced Vital Capacity test)
• Overlapping the F/V loop acquired during exercise and the F/V loop performed at
rest.
O2, CO2 vs Time
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.
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.
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O2 Saturation (optional)
The O2 Saturation event is useful to check the quality of SpO2 signal acquired by the onboard 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 O
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.
Saturation from Test/Event...
2
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.
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.
concentration at the equilibrium and the
2
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.
Chapter 7 - Exercise Testing - 99
concentration and volumes) in Ascii file format in a archive apart at a
2
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.
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