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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.
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Lotus 123 is a registered trademark of Lotus Development Corporation .
2
K4 b
User manual, XII Edition
01/2005
Copyright © 1998 COSMED
Copyright © 2003 COSMED
COSMED Srl - Italy
http://www.cosmed.it
Part N. C01508-02-91

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Summary of Contents for Cosmed K4B2

  • 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.
  • Page 2 Before starting................22 Checking the packing contents ..........22 K4 b standard packaging..........22 Warranty registration..............23 Register the product via software........23 How to contact COSMED..........23 Complain, feedback and suggestions ......23 Options/Accessories ............... 24 Accessories ................24 Options..................24 Telemetry data transmission...........24 Spirometry Kit..............24...
  • Page 3 PC configuration required...............25 Technical features ................26 Portable Unit ..............26 Receiver Unit ..............26 Battery charger Unit ............26 Flowmeter ..............26 Oxygen Sensor (O ) ............26 Carbon Dioxide Sensor (CO ) ........26 Humidity absorber............26 Power Supply ..............26 Environmental Sensors...........26 Measurements Pulmonary function tests and measured parameters ....28 Breath by Breath exercise testing ..........28 Indirect Calorimetry ..............28 Lactate Threshold (V-Slope) ............28...
  • Page 4 Fixing the K4 b to the patient..........38 Connecting the K4 b 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 ..............
  • Page 5 Operating modes 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...
  • 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 Recommendations for the exercise testing ........
  • Page 7 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...
  • 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...
  • Page 9 How to modify the average interval ........104 Print ..................104 Sub-maximal Exercise Testing Introduction...................106 Pre-test screening..............106 Sub-maximal exercise testing............107 Considerations with sub-maximal exercise testing....107 Staffing ...................108 Test termination..............108 Considerations for accuracy ............109 Performing the test ...............110 An example of testing protocol ..........110 Spirometry Setting spirometry options............112 Spirometry ................112...
  • Page 10 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..............125 External devices GPS ....................128 GPS initialisation ..............128 Initialize the GPS............128 Fixing the antenna to the subject..........128 Operating sequence..............129 Run a test with GPS............129 Monitoring GPS parameters in real time......130...
  • Page 11 and VCO ................144 Anaerobic threshold (modified V-Slope) .......144 kinetics ................144 ATS 94 recommendations .............145 ATS recommendations ............145 Predicted values................146 Automatic diagnosis (algorithm) ..........147 Quality Control Messages ............147 References..................149 Gas Exchange References ..........149 Indirect calorimetry............149 Spirometry..............149 Sub-maximal testing.............149 Index - 11...
  • Page 12 12 - K4 b User Manual...
  • Page 13 Getting started...
  • Page 14: Important Notices

    • 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; •...
  • Page 15 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.
  • Page 16: Absolute Contraindications

    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: •...
  • Page 17 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.
  • Page 18: Quality Assurance

    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 •...
  • Page 19 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.
  • Page 20: Telemetry Data Transmission

    System overview Portable Unit (PU) It is fixed to the patient during the test by an anatomic harness. The PU contains the O and CO analyzers, sampling pump, UHF transmitter, barometric sensors and electronics. It is powered by the rechargeable battery fixed to the back side of the harness.
  • Page 21: Gas Analysers

    Flowmeter 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 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.
  • Page 22: Portable Unit

    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 b standard packaging Code...
  • 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.
  • Page 24 Options/Accessories Accessories Code Quantity Description C02150-01-11 Adapter Spirometry kit x opto-reader 2000 C00600-01-11 3 liters syringe for flows and volume calibration C02115-01-10 Adult face mask with x Turbine 2000 C01278-01-30 Mask mouth/nose breath ID28 paediatric L C01277-01-30 Mask mouth/nose breath ID28 paediatric S A 800 900 004 Paediatric Headcap Options...
  • Page 25 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.
  • Page 26: Battery Charger Unit

    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:...
  • Page 27 Measurements...
  • Page 28 Pulmonary function tests and measured parameters Breath by Breath exercise testing Symbol Parameter ml/min Oxygen Uptake VCO2 ml/min Carbon Dioxide production Tidal Volume FetO2 End Tidal O2 FetCO2 End Tidal CO2 Respiratory Quotient l/min Ventilation 1/min Heart Rate Cardiac output Anaerobic Threshold l/min Ventilation...
  • Page 29: Index

    Heart Rate @ LT O2 Kinetics Parameter Calculation deficit VO2@work*tau debt VO2'@work*tau Spirometry Tests (option) FVC - Forced Vital Capacity Symbol Parameter Forced Expiratory Vital Capacity FEV1 Forced Expiratory Volume in 1 sec FEV1/FVC% FEV1 as a percentage of FVC l/sec Peak Expiratory Flow FEV0.5 Forced Expiratory Volume in 0.5 sec...
  • Page 30: Display

    l/min Expiratory Minute Ventilation Tidal Volume 1/min Respiratory Frequency Duration of Inspiration Duration of Expiration Ttot Duration of Total breathing cycle Ti/Ttot —- Ti/Ttot ratio Vt/ti l/sec Vt/ti ratio MVV - Maximum Voluntary Ventilation Symbol Parameter l/min Maximum Voluntary Ventilation Tidal Volume (during MVV) 1/min Maximum Respiratory frequency MVVt...
  • Page 31 Installation...
  • Page 32 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. •...
  • Page 33 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.
  • Page 34: Calibration

    Warm up Important: In order to ensure The K4 b uses O and CO heated sensors. We strongly recommend at least 45 minutes accurate gas measurements, warm-up time at an ambient temperature of 20°C. More time is necessary if the you must wait for a warming-up time before operating the K4 environmental temperature is lower.
  • Page 35 Receiver Unit Optionally the K4 b is provided with a transmitter board (located inside the K4 b 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 b are transmitted "breath by breath"...
  • Page 36 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...
  • Page 37 Apply the seal to the mask Apply seal to clean, residue-free mask only and follow the instructions below: 1. Remove the plastic tray from the bag. Peel off clear film and retain for later use. 2. While holding tray align the nose area of mask to nose area of Ultimate Seal™ gel. Press together and roll mask down over the surface of the gel seal attaching it to the mask and releasing it from the tray.
  • Page 38: The Control Panel

    Fixing the K4 b to the patient 1. Fix the heart belt to the patient’s box thorax. 2. Fix the K4 b unit to the front of the harness. Do the same operation with the battery on the back . 3.
  • Page 39: Connect The Receiver Unit To The Pc

    Connecting the K4 b to the PC K4 b can be connected to any PC provided with serial port in order to monitor "on- line" physiological data during any kind of activity. Connect the Portable Unit to the PC Connect the K4 b Portable Unit to a serial port available in the PC.
  • Page 40: Database Management

    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.
  • Page 41: Print

    To move the scroll bar page by page click on the grey area at both sides of the scroll fields On line help COSMED K4 b 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.
  • Page 42 42 - K4 b User Manual...

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