K4 b User Manual IX Edition Sept 2003

Page 1

Cosmed does not assume the liability for interpretation mistakes of this documentation or for casual or

consequential damages in connection with the provision, representation or use of this documentation.

No parts of this manual may be reproduced or transmitted in any form without the express permission of

COSMED Srl.

COSMED Software can be installed only in one device.

Excel is a registered trademark of Microsoft Corporation.

DBIII is a registered trademark of Bordland International Inc.

Lotus 123 is a registered trademark of Lotus Development Corporation .

K4 b2 User manual, IX Edition

September 2003

Copyright © 1998 COSMED

Copyright © 2003 COSMED

COSMED Srl - Italy

http://www.cosmed.it

Part N. C01508-02-91

Page 3

Technical features ...........................................................................26

Portable Unit.................................................................. 26

Receiver Unit................................................................. 26

Battery charger Unit ...................................................... 26

Flowmeter...................................................................... 26

Oxygen Sensor (O2)....................................................... 26

Carbon Dioxide Sensor (CO2)........................................ 26

Humidity absorber ......................................................... 26

Power Supply................................................................. 26

Environmental Sensors .................................................. 26

Measurements

27

Pulmonary function tests and measured parameters ....................28

Breath by Breath exercise testing............................................. 28

Indirect Calorimetry................................................................. 28

Lactate Threshold (V-Slope).................................................... 28

O2 Kinetics .............................................................................. 29

Spirometry Tests (option) ........................................................ 29

FVC - Forced Vital Capacity......................................... 29

VC/IVC - Slow Vital Capacity and Ventilatory pattern 29

MVV - Maximum Voluntary Ventilation...................... 30

Bronchoprovocation Response ...................................... 30

Installation

31

Installation sequence ......................................................................32

Battery Charger Unit................................................................ 32

Check voltage ................................................................ 32

Turn the Unit on ............................................................ 32

Charge the batteries ....................................................... 32

Battery low .................................................................... 33

Portable Unit ............................................................................ 33

Warm up ........................................................................ 34

Warming-up the unit by main power............................. 34

Turning on/off the portable unit .................................... 34

Connect the rechargeable battery................................... 34

Receiver Unit ........................................................................... 35

Turning on/off the receiver unit..................................... 35

Receiver unit power supply ........................................... 35

Calibration Gas Cylinder ......................................................... 35

Connecting the K4 b2 to the patient ................................................36

Assemble the mask and the flowmeter .................................... 36

Using the "Ultimate Seal" ........................................................ 36

Apply the seal to the mask............................................. 37

To remove seal on mask ................................................ 37

Assembling the flowmeter for spirometry tests ....................... 37

Fixing the K4 b2 to the patient ................................................. 38

Index - 3

Page 4

Connecting the K4 b2 to the PC ....................................................... 39

Connect the Portable Unit to the PC ........................................ 39

Connect the Receiver Unit to the PC ....................................... 39

Software installation....................................................................... 40

Installing the software .............................................................. 40

Run the software ...................................................................... 40

PC port configuration............................................................... 40

Software main features .................................................................. 41

Display ..................................................................................... 41

Tool bar .................................................................................... 41

Show/hide the toolbar .................................................... 41

Dialog windows ....................................................................... 41

Use of the keyboard ....................................................... 41

Use of the mouse............................................................ 41

Scroll bars ................................................................................ 41

On line help.............................................................................. 41

Software version....................................................................... 41

Calibration

43

Gas calibration procedures ............................................................ 44

Running the Calibration program............................................. 44

Log file..................................................................................... 44

Setting reference values ........................................................... 44

Set the reference values using the PC software ............. 44

Set the reference values using the Portable Unit............ 45

Room air calibration................................................................. 45

Room air calibration using the PC software .................. 45

Room air calibration using the Portable Unit................. 45

Reference gas calibration ......................................................... 45

The calibration unit........................................................ 46

Reference gas calibration using the PC software........... 46

Reference gas calibration using the Portable Unit ......... 46

Gas delay calibration................................................................ 47

Delay calibration using the PC software........................ 47

Delay calibration using the Portable Unit ...................... 47

Print the calibration report ....................................................... 48

Edit the calibration factors ....................................................... 48

Turbine calibration ......................................................................... 49

Assembling the flowmeter for calibration .................... 49

Calibrating the turbine.............................................................. 49

Turbine calibration using the PC software..................... 49

Turbine calibration using the Portable Unit................... 50

Checking the system signals........................................................... 51

The control panel...................................................................... 51

Using the control panel .................................................. 51

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Operating modes

53

2

K4 b Operating modes ..................................................................54

Holter Data Recorder ............................................................... 54

Telemetry Data Transmission (option) .................................... 54

Serial (Laboratory) Station....................................................... 54

Portable Unit User Interface diagram ............................................55

Holter Data Recorder Mode ............................................................56

Operating sequence.................................................................. 56

Warming-up the system................................................. 56

Enter new patient ........................................................... 56

Calibrate and start the test.............................................. 56

Stop the test ................................................................... 57

Transferring test to PC................................................... 57

Telemetry Data Transmission Mode................................................58

Operating sequence.................................................................. 58

Warming-up the system................................................. 58

Connect the receiver unit to the PC ............................... 58

Enable transmission....................................................... 58

Enter new patient ........................................................... 58

Enable reception on PC ................................................. 59

Calibrate and start the test.............................................. 59

Stop the test ................................................................... 60

Transferring test to PC................................................... 60

Serial Mode .....................................................................................61

Operating sequence.................................................................. 61

Warming-up the system................................................. 61

Connect the Portable unit to the PC............................... 61

Calibrate the system....................................................... 61

Enter patient data ........................................................... 61

Start the test ................................................................... 62

Stop the test ................................................................... 62

Database Management

63

Exercise testing patient's database.................................................64

Enter a new patient................................................................... 64

Find a patient............................................................................ 64

Edit patient data ....................................................................... 64

Delete a patient ........................................................................ 64

Uploading tests from the Portable Unit ..........................................65

Archive maintenance ......................................................................66

Reorganise the archive ............................................................. 66

Delete the archive .................................................................... 66

Delete a test.............................................................................. 66

Backup and restore................................................................... 66

Backup ........................................................................... 66

Restore ........................................................................... 66

Index - 5

Page 6

Spirometry patient's database........................................................ 67

Patient Card.................................................................... 67

Visit Card....................................................................... 67

Test Card........................................................................ 68

Import/export a Tests card ....................................................... 68

Diagnosis Database .................................................................. 68

Spirometry program settings.......................................................... 69

Graphs............................................................................ 69

Serial port....................................................................... 69

Units of measurements................................................... 69

Using extra fields ........................................................... 69

Customise the fields....................................................... 69

Exercise testing

71

Recommendations for the exercise testing..................................... 72

The evaluation of the cardiorespiratory function ..................... 72

Precautions ............................................................................... 72

Laboratory...................................................................... 72

Ending the test ............................................................... 72

Preparing the patient ................................................................ 72

Before testing................................................................. 72

Patient assent.................................................................. 73

Ending the test ............................................................... 73

Real time test .................................................................................. 74

Start a test....................................................................... 74

Abort the test without saving data ................................. 74

End the test saving data ................................................. 74

View data in real-time.............................................................. 74

View graphs in real-time................................................ 74

Parameters to view ................................................................... 74

Manual protocol ....................................................................... 75

Enter Load and Phase .................................................... 75

Set the markers............................................................... 75

Automatic protocol................................................................... 75

Modify the load during the test...................................... 75

Set the BPM alarm ................................................................... 75

Enter the BPM ............................................................... 75

Data management.......................................................................... 76

Viewing data ............................................................................ 76

View data in table form ................................................. 76

Creating graphs ........................................................................ 76

View data in graph form ................................................ 76

Customise the graphs ..................................................... 77

Switch from graph to data and vice versa...................... 77

Viewing predicted values......................................................... 78

View predicted values.................................................... 78

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Anaerobic (Lactate) Threshold detection................................. 78

View the Lactate Threshold........................................... 78

Detect the Lactate Threshold ......................................... 78

Customise graphs for the LT viewing............................ 78

Fittings ..................................................................................... 79

Fit a graph with a linear regression................................ 79

Fit a graph with a Mono-exponential regression ........... 79

Calculate the "Mean Value" .......................................... 80

Oxygen Kinetic ........................................................................ 80

Run the O2 Kinetic function.......................................... 80

Information about the Test....................................................... 81

View the Information..................................................... 81

Modify the information.................................................. 81

Summary .................................................................................. 81

View the summary......................................................... 81

Print the data ............................................................................ 81

Print the current window ............................................... 82

Print the report ............................................................... 82

View the report ........................................................................ 82

Data Editing ....................................................................................83

Editing values and input numerical values .................... 83

Data filtering.................................................................. 83

Using the User fields ..................................................... 84

Deleting steps ................................................................ 84

Advanced Editing .......................................................... 84

Restore the original test ................................................. 85

Overwrite the original test ............................................. 85

Customise the desktop ............................................................. 85

Customise the display colours ....................................... 85

Smart edit ................................................................................. 85

Apply the graphical noise suppression .......................... 85

Apply the threshold noise suppression .......................... 85

Customise the parameters ........................................................ 86

Create a new parameter ................................................. 86

Create a new predicted parameter................................... 86

Exporting data.......................................................................... 87

Export a test ................................................................... 87

DDE with Excel............................................................. 87

Creating Test Protocols....................................................................88

Create a new protocol .................................................... 88

Software configuration....................................................................89

Data viewing ............................................................................ 89

Select the parameters to view ........................................ 89

Select the parameters to view during the test ................ 89

Sort the parameters ........................................................ 89

Steady State.............................................................................. 89

Index - 7

Page 8

Customise the Steady State detection criteria................ 89

Printout reports............................................................................... 90

Set up the printout.......................................................... 90

Select parameters to be printed ...................................... 90

Customise the printout header ....................................... 90

Electronic reports (*.pdf) ............................................... 91

Print the current window.......................................................... 91

Print the customised report....................................................... 91

Events management during exercise testing ................................. 92

Flow Volume loops .................................................................. 92

Flow Volume loop during the test ................................. 92

O2, CO2 vs Time ..................................................................... 92

O2, CO2 vs Time during the test ................................... 92

O2 Saturation (optional)........................................................... 93

O2 Saturation during the test ......................................... 93

Spirogram................................................................................. 93

Spirogram during the test............................................... 93

View the events after the test ................................................... 93

Raw data................................................................................... 93

Save Raw data................................................................ 94

Resting Metabolic Rate Test

95

Metabolism ..................................................................................... 96

Total Metabolic Rate................................................................ 96

Resting Metabolic Rate (RMR)................................................ 96

Importance to measure RMR ................................................... 96

Measure of the rest metabolic rate with indirect calorimetry... 96

How to perform a RMR test..................................................... 96

Recommendations .......................................................................... 97

Performing a test ............................................................................ 98

Calibrations .............................................................................. 98

How to prepare a patient .......................................................... 98

Start the test.............................................................................. 98

Viewing the test........................................................................ 99

How to modify the average interval....................................... 100

Print........................................................................................ 100

Sub-maximal Exercise Testing

103

Introduction .................................................................................. 104

Pre-test screening ................................................................... 104

Sub-maximal exercise testing....................................................... 105

Considerations with sub-maximal exercise testing ................ 105

Staffing................................................................................... 106

Test termination ..................................................................... 106

Considerations for accuracy.......................................................... 107

Performing the test ....................................................................... 108

An example of testing protocol .............................................. 108

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Spirometry

109

Setting spirometry options ............................................................110

Spirometry.............................................................................. 110

Automatic Interpretation.............................................. 110

Quality control............................................................. 110

Parameters manager ............................................................... 111

Predicted values manager....................................................... 111

Predicteds set ............................................................... 111

Set the current predicted .............................................. 112

Formula definition ....................................................... 112

Page set-up ............................................................................. 113

Spirometry tests.............................................................................114

Forced Vital Capacity (pre)............................................................115

Recommendations.................................................................. 115

Perform a FVC (pre) test........................................................ 115

Test encouragement ............................................................... 115

Perform the FVC test with the encouragement............ 116

Slow Vital Capacity ........................................................................117

Perform a SVC test ................................................................ 117

Maximum Voluntary Ventilation ...................................................118

Perform a MVV test............................................................... 118

Bronchial Provocation Test............................................................119

Bronchodilator test................................................................. 119

Methacholine and Histamine Bronchial provocation Tests ... 119

Perform the test ...................................................................... 120

Bronchial Provocation protocols Database ............................ 120

Enter a new Bronchial provocation protocol in the

archive ......................................................................... 120

Viewing results ..............................................................................121

Tests of the current patient .......................................... 121

Delete a test ................................................................. 121

Printing results ..............................................................................122

Printing Reports ..................................................................... 122

Printing the active window .................................................... 122

To print the active window .......................................... 122

Printing a series of reports ..................................................... 122

Electronic reports (*.pdf) ....................................................... 122

Export data ............................................................................. 123

Export a test ................................................................. 123

External devices

125

GPS ................................................................................................126

GPS initialisation ................................................................... 126

Initialize the GPS......................................................... 126

Fixing the antenna to the subject ............................................ 126

Operating sequence................................................................ 127

Run a test with GPS..................................................... 127

Index - 9

Page 10

Monitoring GPS parameters in real time ..................... 128

Pulse Oximeter (option) ................................................................ 129

Operating Sequence ............................................................... 129

System maintenance

131

System maintenance..................................................................... 132

Cleaning and disinfection....................................................... 132

Cleaning the turbine flowmeter ................................... 132

Precautions during the cleaning of the turbine............. 133

Suggested disinfection solutions.................................. 133

Masks cleaning and disinfection ............................................ 133

Disassembling the different parts of the mask ............. 133

Cleaning the mask........................................................ 133

Disinfecting the mask .................................................. 133

Permapure maintenance ......................................................... 134

Inspections ............................................................................. 134

Replace the fuses.................................................................... 134

Appendix

137

Service - Warranty ........................................................................ 138

Warranty and limitation of liability........................................ 138

Return goods policy for warranty or non warranty repair...... 138

Repair Service Policy............................................................. 139

Privacy Information ...................................................................... 140

Personal data treatment and purposes .................................... 140

How your personal data are treated........................................ 140

The consent is optional, but… ............................................... 140

Holder of the treatment .......................................................... 140

Customer rights ...................................................................... 140

Converting factors configuration .................................................. 141

Calculations references................................................................. 142

VO2 and VCO2........................................................................ 142

Anaerobic threshold (modified V-Slope)............................... 142

O2 kinetics .............................................................................. 142

ATS 94 recommendations ............................................................. 143

ATS recommendations........................................................... 143

Predicted values ........................................................................... 144

ERS93 .................................................................................... 144

Reference Adult: .......................................................... 144

Reference Paediatric: ................................................... 144

KNUDSON 83 ....................................................................... 144

Reference Adult/ Paediatric: ........................................ 144

ITS (White race)..................................................................... 144

Reference Adult/ Paediatric: ........................................ 144

ITS (Black race) ..................................................................... 144

Reference Adult/ Paediatric: ........................................ 144

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LAM....................................................................................... 144

Reference Adult/ Paediatric:........................................ 144

Multicéntrico de Barcelona.................................................... 144

Reference Adult/ Paediatric:........................................ 144

NHANES III .......................................................................... 144

Reference Adult/ Paediatric:........................................ 144

Automatic diagnosis (algorithm) ........................................... 145

Quality Control Messages...................................................... 145

References .....................................................................................146

Gas Exchange References............................................ 146

Indirect calorimetry ..................................................... 146

Spirometry ................................................................... 146

Sub-maximal testing .................................................... 146

Index - 11

Page 12

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Page 13

Getting started

Page 14

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 VO2 and VCO2 in a

field setting.

Such a portable apparatus may also be useful to determine the energy cost of many sport

and real life activities.

K4 b2 is an electrical medical device designed to perform pulmonary function tests. It is

to be used by physicians or by trained personnel on a physician responsibility.

Caution: Federal law restricts this device to sale by or on the order of a physician.

This equipment has been conceived with the aim of providing an auxiliary instrument

allowing:

•

the formulation of lung pathology diagnosis;

•

important studies concerning human physiology;

• the collection of important information in sport medicine.

No responsibility attaches COSMED Srl for any accident happened after a wrong use of

the device, such as:

•

use by non qualified people;

•

non respect of the device intended use;

•

non respect of the hereunder reported precautions and instructions.

Warnings

The device, the programme algorithms and the presentation of measured data have been

developed according to the specifications of ATS (American Thoracic Society) and

ERS (European Respiratory Society). Other international references have been followed

when these were not available. All bibliography references are reported in Appendix.

The present handbook has been developed with respect of the European Medical Device

Directive requirements which sort K4 b2 within Class II a.

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

into operation.

The precautions reported below are of fundamental importance to assure the safety of

all COSMED equipment users.

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

always be kept on hand.

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

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

non recommended accessories can affect safety unfavourable. Before using non

recommended accessories it is necessary to get in touch with the manufacturer;

• ordinary equipment maintenance, inspections, disinfection and cleaning are

performed in the way and with the frequency described;

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

• 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.

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Page 15

3.

4.

5.

6.

7.

8.

9.

10.

11.

12.

13.

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

electrical parts must be replaced immediately by authorised personnel.

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

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

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

dirt, oil or grease. Remove any dust or dirt with a clean cloth. If oil or grease is

present on the valve of a cylinder which contains oxygen, do not attempt to use.

Such combustible substances in contact with oxygen are explosive.

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

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

connection and note the ranges of the pressure gauges. Also examine the physical

condition of the regulator including threads and fittings. Remove any dust or dirt

from the regulator or cylinder valve with a clean cloth. Do not install a regulator on

a cylinder valve containing oxygen if grease or oil is present on either. Such

substances in contact with oxygen are explosive.

Cleaning residue, particulates, and other contaminates (including pieces of torn or

broken components) in the breathing circuit pose a safety risk to the patient during

testing procedures. Aspiration of contaminates can potentially be life-threatening.

You must follow all the cleaning procedures in System Maintenance, and you must

thoroughly inspect the components after cleaning and before each patient test.

This device is not suitable for use in presence of flammable anaesthetics. It is not

an AP nor an APG device (according to the EN 60 601-1 definitions).

Keep the device away from heat and flame source, flammable or inflammable

liquids or gases and explosive atmospheres.

In accordance with their intended use K4 b2 is not to be handled together with other

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

It is recommended to use a computer with electromagnetic compatibility CE

marking and with low radiation emission displays.

It is necessary to make the PC, connected to the K4 b2, compliant with EN 60601-1

by means of an isolation transformer.

Graphical symbols used in accordance to present specifications are described here

below:

Equipment type B (EN60601-1)

Danger: high temperature

OFF

ON

Protective earth ground

Alternating current

Chapter 1 - Getting started - 15

Page 16

Contraindication

The physical strain to execute the respiratory manoeuvre is contraindicated in case of

some symptoms or pathology. The following list is not complete and must be

considered as a piece of mere information.

Contraindications for the Spirometer tests

Absolute contraindications

For FVC, VC and MVV tests:

• Post-operating state from thoracic surgery

For FVC tests:

•

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

•

Bronchial non-specific marked hypersensitivity

•

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

Relative contraindications

For FVC tests:

•

spontaneous post-pneumothorax state

•

arterial-venous aneurysm

•

strong arterial hypertension

• pregnancy with complications at the 3rd month.

For MVV test:

•

hyperventilation syndrome

Contraindications for Bronchial provocation tests

The bronchial provocation tests must be executed according to the doctor’s discretion.

There are not data that reveal specific contraindication for the bronchial provocation test

through inhalation.

The modern standard processes have been revealing secure in several clinical studies.

However it is recommendable to respect the following contraindications:

Absolute contraindications

•

Serious bronchial obstruction (FEV1 in adults)

•

Recent myocardium infarct

•

Recent vascular-cerebral accident

•

Known arterial aneurysm

•

Incapacity for understanding the provocation test procedures and its implications.

Relative contraindications

•

Bronchial obstruction caused by the respiratory manoeuvre.

•

Moderate or serious bronchial obstruction. For ex. Predicted value FEV1 less than

1.51 in men and predicted value FEV1 in women less than 1.21.

•

Recent infection in the superior air tracts

•

During the asthmatic re-acuting

•

Hypertension

•

Pregnancy

•

A pharmacology treatment epilepsy

Contraindications for Exercise testing

Read carefully the exercise testing chapter.

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Environmental condition of use

COSMED units have been conceived for operating in medically utilised rooms without

potential explosion hazards.

The units should not be installed in vicinity of x-ray equipment, motors or transformers

with high installed power rating since electric or magnetic interferences may falsify the

result of measurements or make them impossible. Due to this the vicinity of power lines

is to be avoided as well.

Cosmed equipment are not AP not APG devices (according to EN 60601-1): they are

not suitable for use in presence of flammable anaesthetic mixtures with air, oxygen or

nitrogen protoxide.

If not otherwise stated in the shipping documents, Cosmed equipment have been

conceived for operating under normal environmental temperatures and conditions [IEC

601-1(1988)/EN 60 601-1 (1990)].

•

Temperature range 10°C (50°F) and 40°C (104°F).

•

Relative humidity range 20% to 80%

•

Atmospheric Pressure range 700 to 1060 mBar

•

Avoid to use it in presence of noxious fumes or dusty environment and near heat

sources.

•

Do not place near heat sources.

•

Cardiopulmonary resuscitation emergency equipment accessible.

•

Adequate floor space to assure access to the patient during exercise testing.

•

Adequate ventilation in the room.

Chapter 1 - Getting started - 17

Page 18

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 ISO 9001 (Registration n° 387 Cermet)

Medical Device Directive (CE mark)

MDD 93/42/EEC (Notified Body 0476).

Class IIa

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Keynotes

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

Typographic keynotes

These are the typographic keynotes used in the manual.

Style

Description

Bold

“Italic”

indicates a control or a key to be pressed.

indicates a messages shown by the firmware.

Graphic keynotes

These are the graphic keynotes used in the manual.

Illustration

Description

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

Chapter 1 - Getting started - 19

Page 20

System overview

Portable Unit (PU)

It is fixed to the patient during the test by an anatomic

harness. The PU contains the O2 and CO2 analyzers, sampling

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, VO2, VCO2, R,

HR, Rf Marker, battery charge level, temperature and

barometric pressure.

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.

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Flowmeter

The system uses a bi-directional digital turbine. It opposes a very low resistance to flow

(<0,7 cmH2O/l/s to 12 l/s). The air passing through the helical conveyors, takes a spiral

motion which causes the rotation of the turbine rotor. The rolling blade interrupts the

infrared light beamed by the three diodes of the optoelectronic reader. Every

interruption represents 1/6 turn of the rotor, this allows to measure the number of turn in

the time.

Gas analysers

The O2 and CO2 analysers are temperature-controlled and the internal pressure and

expired flow are monitored for an higher reliability if the measurements.

The 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.

PC Software

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).

•

O2 Kinetics (O2 deficit, O2 debt and time constant in both rising and falling edge of

a constant load exercise test).

•

Flow-Volume loops during the test and overlapped on the rest FVC.

•

Real time display of the O2 and CO2 waveforms during the test.

•

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 - 21

Page 22

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.

K4 b2 standard packaging

Code

C00950-01-04

C00952-01-04

C01599-01-04

C00260-01-04

C01570-01-06

C00342-01-12

C02120-01-05

C02200-01-11

A 800 900 001

C02210-01-08

C02125-01-10

C02135-01-10

C02145-01-10

A 661 200 001

A 661 200 002

A 182 320 001

C01460-01-06

A 362 060 001

C01507-01-12

C00659-01-12

A 410 110 002

C02100-02-06

C00341-01-12

C01577-01-12

C01929-01-08

C01143-01-98

C01800-01-05

C01509-01-30

C01588-01-20

A 680 023 500

A 680 044 500

C01506-02-35

C01999-02-DC

C00067-02-94

C01508-02-91

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22 - K4 b User Manual

Qty

1

1

1

1

1

1

1

1

2

1

1

1

1

1

1

2

1

1

1

1

4

3

1

1

1

1

1

1

1

2

1

1

1

1

1

Description

K4 b2 Portable Unit (only non telemetric version)

K4 b2 Portable Unit (only telemetric version)

K4 b2 Receiver Unit (only telemetric version)

K4 b2 Battery Charger Unit

Antenna

Antenna cable

Turbine Ø 28mm

Kit optoelectronic reader K4 b2

Head cap for the adult masks

Permapure L73cm

Mask mouth/nose breath adult S

Mask mouth/nose breath adult M

Mask mouth/nose breath adult L

HR elastic belt

HR polar transmitter

Anti moisture filter

RH/TA probe

Power cord Schuko 2m

RS232 cable K4 b2

Cigar light adapter

Battery size AA 1,5V

Battery pack TX K4 b2

Cable power supply BNCxRF

Cable power supply RX unit

Harness K4 b2 adult

Velcro strips (set 8 pieces)

Kit gas calibration

Carrying case

Holder Portable Unit

Time lag fuses 5x20 250V T500mA

Fuses 6,3x32 250V F5A

PC software

Conformity declaration

Registration card

K4 b2 User Manual

Page 23

Warranty registration

Before using the system, please take a moment to fill in the registration form and the

warranty and return them to COSMED, by doing this you are eligible to the customers

assistance service.

For further information, please refer to the enclosed registration and warranty form. If

the form is not enclosed in the packaging, please contact directly COSMED.

Register the product via software

Together with the PC software, a registration software is supplied. With this software it

is possible to fill in an electronic form with the customer information.

1. To run the software, double click on the icon Registration or select Registration…

from ? menu.

2. Type the requested information and click Send… to send the form via e-mail to

COSMED.

How to contact COSMED

For any information you may need, please contact the manufacturer directly at the

following address:

COSMED S.r.l.

Via dei Piani di Monte Savello, 37

P.O. Box n. 3

00040 - Pavona di Albano

Rome - ITALY

Voice: +39 (06) 931.5492

Fax: +39 (06) 931.4580

email: customersupport@cosmed.it

Internet: http: //www.cosmed.it

Complain, feedback and suggestions

If you have any complain, feedback information or suggestion, please inform us at

complain@cosmed.it.

Chapter 1 - Getting started - 23

Page 24

Options/Accessories

Accessories

Code

Quantity

C02150-01-11

C00600-01-11

C02115-01-10

C01278-01-30

C01277-01-30

A 800 900 004

1

1

1

1

1

1

Description

Adapter Spirometry kit x opto-reader 2000

3 liters syringe for flows and volume calibration

Adult face mask with x Turbine 2000

Mask mouth/nose breath ID28 paediatric L

Mask mouth/nose breath ID28 paediatric S

Paediatric Headcap

Options

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.

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24 - K4 b User Manual

Page 25

PC configuration required

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Pentium 133 MHz.

•

Windows 95, 98, XP.

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16 Mb RAM .

•

3.5 drive.

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VGA, SVGA monitor.

•

Serial Port RS 232 available (2 serial ports in case of Ergometer control). An USB

port can replace one RS232 serial port, if using the USB-RS232 adaptor (Cosmed

code A 388 410 001).

•

Any Mouse and Printer compatible with the MS Windows™ operative system.

•

PC conform to European Directive 89/336 EMC

Chapter 1 - Getting started - 25