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.
Table of contents Getting started 13 Important notices ........................................................................... 14 Intended use..............................................................................14 Warnings...................................................................................14 Contraindication ............................................................................. 16 Contraindications for the Spirometer tests................................
PC configuration required...............................................................25 Technical features ...........................................................................26 Portable Unit ..................................................................26 Receiver Unit .................................................................26 Battery charger Unit .......................................................26 Flowmeter .....................................................................
Fixing the K4 b2 to the patient..................................................38 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.............................................................
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 .......................................
Spirometry patient's database ....................................................... 67 Patient Card ....................................................................67 Visit Card .......................................................................67 Test Card ........................................................................68 Import/export a Tests card ........................................................68 Diagnosis Database................................................................
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........
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 ...................
How to modify the average interval .......................................104 Print ........................................................................................104 Sub-maximal Exercise Testing 105 Introduction...................................................................................106 Pre-test screening....................................................................106 Sub-maximal exercise testing.......................................................
Printing the active window .....................................................124 To print the active window...........................................124 Printing a series of reports ......................................................124 Electronic reports (*.pdf)........................................................124 Export data..............................................................................125 Export a test..................................................................
VO2 and VCO2 ........................................................................144 Anaerobic threshold (modified V-Slope) ...............................144 O2 kinetics ..............................................................................144 ATS 94 recommendations .............................................................145 ATS recommendations ...........................................................145 Predicted values...................................................................
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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.
3. 4. 5. 6. 7. 8. 9. 10. 11. 12. 13. 14. 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.
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.
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.
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 1
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.
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.
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.
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 sss Note: a: Non telemetric version b: Internat.
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.
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
PC configuration required • Pentium II 350 MHz. • Windows 98, XP. • 64 Mb RAM . • CD drive. • VGA, SVGA monitor. • Serial Port RS 232 available (2 serial ports in case of Ergometer control). An USB port can replace one RS232 serial port, if using the USB-RS232 adaptor (Cosmed code A 388 410 001). • Any Mouse and Printer compatible with the MS Windows™ operative system.
Technical features Portable Unit Memory Display LCD Keyboard: Serial Port Power supply: Thermometer: Barometer: Dimensions PU : Dimensions battery: Weight: 16,000 breaths 2 lines x 16 characters waterproof, 6 keys RS 232C Ni-MH rechargeable batteries 3 hours endurance 0-50°C 53-106 Kpa 170x55x100 mm, 120x20x80 mm 400g Receiver Unit Transmission range: Battery: Dimension: Weight: PC interface: 800 meters 4 x 1.
Measurements
Pulmonary function tests and measured parameters Breath by Breath exercise testing Symbol UM Parameter VO2 VCO2 Vt FetO2 FetCO2 R VE HR Qt AT VE SV RF FeO2, FeCO2 VE/VO2 VE/VCO2 VO2/HR VO2/Kg Ti, Te, Ti/Ttot Vd/Vt PaCO2 P(a-et)CO2 ml/min ml/min l % % --l/min 1/min l --l/min l/min 1/min % ----ml/beat ml/min/Kg sec --mmHg mmHg Oxygen Uptake Carbon Dioxide production Tidal Volume End Tidal O2 End Tidal CO2 Respiratory Quotient Ventilation Heart Rate Cardiac output Anaerobic Threshold Ventilation Stroke vo
HR bpm Heart Rate @ LT Parameter UM Calculation O2 deficit O2 debt l/m l/m VO2@work*tau VO2'@work*tau O2 Kinetics Spirometry Tests (option) FVC - Forced Vital Capacity Symbol UM Parameter FVC FEV1 FEV1/FVC% PEF FEV0.5 FEV6 FEV1/FEV6 FEV6/FVC% Best FVC Best FEV1 Best PEF Vmax25% Vmax50% Vmax75% FEF25-75% FET100% FEV2 FEV3 FEV2/FVC% FEV3/FVC% FEV1/VC% FEF50-75% FEF75-85% FEF0.2-1.
VE Vt Rf Ti Te Ttot Ti/Ttot Vt/ti l/min l 1/min sec sec sec —l/sec Expiratory Minute Ventilation Tidal Volume Respiratory Frequency Duration of Inspiration Duration of Expiration Duration of Total breathing cycle Ti/Ttot ratio Vt/ti ratio MVV - Maximum Voluntary Ventilation Symbol UM Parameter MVV MVt MRf MVVt l/min l 1/min sec Maximum Voluntary Ventilation Tidal Volume (during MVV) Maximum Respiratory frequency MVV duration time Bronchoprovocation Response 2 30 - K4 b User Manual Symbol UM Pa
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 b2 Portable Unit directly by the main power.
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.
Warm up sss 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 45 minutes. 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. sss 1. 2.
Receiver Unit Optionally the K4 b2 is provided with a transmitter board (located inside the K4 b2 unit) 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 b2 are transmitted "breath by breath" to the 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.
Connecting the K4 b2 to the patient K4 b2 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 b2 and battery) on the back of the subject to increase comfort and to avoid any obstacles during movements.
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.
Fixing the K4 b2 to the patient 1. 2. 3. 4. 5. 6. 7. Fix the heart belt to the patient’s box thorax. Fix the K4 b2 unit to the front of the harness. Do the same operation with the battery on the back . Connect the battery cable to the 6V plug of the K4 b2 control panel. Be sure that the red plug, that repairs the plug from water or sweat drops, is on the Portable Unit side. Connect the antenna cable to the Antenna plug of Portable Unit control panel.
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 K4 b2 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.
Software installation The software is made of two programs: one for the ergometry and the other one for the spirometry (option). The two programs share the same archive and use the same program for the system calibration, even if they are used for performing completely different tests. Installing the software sss Notice: The software is copy-protected. Install the software from the original disk. 1. 2. 3. 4. 5. 6. Select Run... from Windows Start menu. Insert the disk in the proper drive.
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.
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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 CO2 analyzer and the gain of the O2 analyzer, in order to match the readings with the predicted athmospheric values (20.93% for O2 and 0.03% for CO2).
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 Room Air calibration is forced to be performed before each test. With this procedure the sss Note: After turning on the unit, wait 45 minutes warm up time before starting the calibration procedure.
have available a cylinder filled of a concentration known of mixed gas. It is suggested to use CO2 5,00% , O2 16% concentrations and N2 for balance. The calibration unit The gas regulator has an adjustable second stage that must be open every time the Notice: Before calibrating be cylinder is used for the calibration. This is necessary to avoid a small leakage in the sure the "Reference values" connections can discharge the bottle in few time. of room air and reference 1.
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.
4. 5. When the message “Connect the sampling line and press Enter” appears press Enter and start breathing at a constant rate. The software helps to maintain a constant rate by means of a beep sound. It is not important to maintain the same rate suggested by the system but it is most important to breath constantly. 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.
Turbine calibration The system uses a turbine flowmeter. It opposes a very low resistance to flow. 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.
expiratory strokes in order to get the first values appearing on the display. Then move the syringe piston for other 10 strokes (IN and EX). 4. 5. At each of the 10 steps the software displays the results of the manoeuvre and the percentage error in the reading. At the end of this operation, the software displays the new calibration factors. Press OK to store the new value. Turbine calibration using the Portable Unit 2 50 - K4 b User Manual 1. 2.
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 b2. 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).
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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).
Portable Unit User Interface diagram Chapter 5 - Operating modes - 55
Holter Data Recorder Mode 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 b2 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. 2. 3. 4. 5. 6. 7. sss Note: USA and Japan versions have the items 3 and 5 slightly different because of the antenna placement.
3. The message "Insert relative humidity" will be visualized, type the correct value and press Enter. 4. The K4 b2 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, VO2, VCO2,...) will be shown and updated each breath on the control panel display.
Telemetry Data Transmission Mode sss Note: USA and Japan versions have the items 3 and 5 slightly different because of the antenna placement. 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. 2. 3. 4. 5. 6. 7. 8. 9. 10.
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. 2. 3. 4. 5. 6. Run K4 b2 software. 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. Choose Execute test from the Test menu.
5. 6. 7. Connect the sampling plug to the optoelectronic reader. Some values (Heart Rate, R, VO2, VCO2,...) will be shown and updated each breath on the control panel 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. After having pressed the Enter key the test starts but the K4b2 is not storing data.
Serial Mode sss Note: USA and Japan versions have the items 3 and 5 slightly different because of the antenna placement. 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 b2 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. 2. 3. 4. 5. 6. 7. 8. 9. 10.
Start the test 1. 2. 3. 4. 5. 6. 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. Choose Execute test from the Test menu. 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. Chose Other Data if you want to insert other important informationon the the you are going to perform.
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. 2. Press New to show the Patient dialog box. Enter data of a new patient and press OK button to confirm.
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. 5. 6. 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.
Archive maintenance The software allows to manage files selecting Archive from the File menu. It is advisable to perform the archive reorganisation every month, in order to free space on the hard disk and/or to correct possible errors present within the database. It is possible also that your have no more hard disk space. So, you have to delete all the data. In this case, it is useful to perform the initialising. Reorganise the archive 1. 2. Select Reorganize archive from the File menu.
Spirometry patient's database The Patients database consists of a Patient Card, a Visit Card and a Test Card in which are listed all tests performed by the patient. Select Archive Navigator from the File menu or press the button by side. Patient Card It collects all the information of a patient (first name, last name, date of birth) which remain the same for each visit. For each patient there is only one Patient Card, which is created the first time the Patient performs a test.
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.
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.
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