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Cosmed K5 Manual

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COSMED does not assume any liability for end user interpretation of this user manual or for casual or consequential damages in connection with the
provision, representation or use of this documentation.
No parts of this manual may be reproduced or transmitted in any form without the expressed written permission of COSMED Srl.
Each copy of the COSMED Software can only be installed on one computer.
Excel is a registered trademark of Microsoft Corporation.
DBIII is a registered trademark of Bordland International Inc.
Lotus 123 is a registered trademark of Lotus Development Corporation.
K5 User manual, I Edition
05/2015
Copyright © 2014 COSMED
COSMED Srl - Italy
http://www.cosmed.com
Part N. C04255-02-91

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Summary of Contents for Cosmed K5

  • Page 1 COSMED does not assume any liability for end user interpretation of this user manual or for casual or consequential damages in connection with the provision, representation or use of this documentation. No parts of this manual may be reproduced or transmitted in any form without the expressed written permission of COSMED Srl.

  • Page 3: Table Of Contents

    Installation ......................................25  Before starting........................................26  Checking the packing contents ..................................26  Device packaging ......................................26 K5 standard packaging....................................26  Optional modules......................................27  Packaging of optional modules ................................... 27 Long Distance bluetooth module standard packaging ..........................27 ...
  • Page 4  Patient’s preparation ......................................34  Assemble the mask and the flowmeter ................................ 34  Fixing the K5 to the subject ..................................34 Fixing HR elastic belt on the subject ................................35 Fixing the mask to the subject’s face ................................35 Positioning ECG electrodes (if an ecg is used) ...............................
  • Page 5  Control Panel ......................................43  Navigation ........................................43  Calibration ......................................... 45  Calibration frequency ....................................45  Flowmeter calibration ....................................45 Perform a turbine calibration ..................................45  Preface to the analyzers calibration ................................45  Reference Gas calibration .................................... 46 ...
  • Page 6 Disinfecting the mask ....................................58 Sterilizing the mask ..................................... 59 Reassembling the mask and components ..............................59  Cleaning the headcap assembly ................................... 59  Sampling line maintenance (Permapure) ................................60  Inspections ......................................... 61 Appendix ......................................63  Declaration of conformity ....................................64 ...
  • Page 7 Sub-maximal exercise testing ..................................73 Oximeter ........................................73 Table of contents - Important notices - 7...

  • Page 9: Getting Started

    Getting started...

  • Page 10: Important Notices

    Such a portable apparatus may also be useful to determine the energy cost of many sport and real life activities. K5 is an electrical medical device designed for the measurement of cardio respiratory and physiological parameters at rest and during exercise on spontaneously breathing human subjects from the age of 3 and older and animals within compatible measurement ranges.
  • Page 11 Do not use other cables since they cannot guarantee this insulation and they can cause serious injuries to the patient. 23. If the product is damaged (e.g. as a result for a free fall), the IP degree of the device itself can be altered. Please do not use K5 and send it back to COSMED or to an authorized center for a technical service.

  • Page 12: Contraindications

     Contraindications Performing forced expiratory manoeuvres involved in spirometry testing may be contraindicated in certain conditions.  Contraindications for Exercise testing Absolute contraindications Acute MI (within 2 days) • High-risk unstable angina • Uncontrolled cardiac arrhythmias causing symptoms of hemodynamic compromise •...

  • Page 13: Environmental Condition Of Use

    Equipment should not be installed near electrical or magnetic devices such as x-ray equipment, transformers or power lines. These devices could create electrical interferences when performing testing procedures. COSMED devices are not AP or APG units (according to EN 60601-1) and should never be operated in the presence of flammable anaesthetic mixtures.

  • Page 14: Emc

     Guidance and manufacturer’s declaration - electromagnetic emissions The device is intended for use in the electromagnetic environment specified below. The customer or the user of the device should assure that it is used in such an environment. Emissions test Compliance Electromagnetic environment –...
  • Page 15 Guidance and manufacturer’s declaration - electromagnetic immunity The device is intended for use in the electromagnetic environment specified below. The customer or the user of the device should assure that it is used in such an environment. Immunity test Test level Compliance level Electromagnetic environment –...
  • Page 16 Guidance and manufacturer’s declaration - electromagnetic immunity The device is intended for use in the electromagnetic environment specified below. The customer or the user of the device should assure that it is used in such an environment. Immunity test Test level Compliance level Electromagnetic environment –...
  • Page 17 Recommended separation distances between portable and mobile RF communications equipment and the device The device is intended for use in an environment in which radiated RF disturbances are controlled. The customer or the user of the device can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the device as recommended below, according to the maximum output power of the communications equipment.

  • Page 18: Overview Of The Manual

    Getting started. Describes the intended use of the device, how to properly use it and features of the unit and accessories. Installation. Lists the steps required to properly install the device. K5 Operation: illustrates the functions of the device including managing data and test performance. System maintenance. Describes system maintenance procedures.

  • Page 19: System Overview

     The bluetooth PC module is an option for the K5 Long distance module, and it is used together its antenna on the PC for receiving data from the K5 unit if the standard Bluetooth transmission range cannot be met (approximately over 30-50 meters). It allows communication between the devices...

  • Page 20: Battery Charger And Batteries

    Battery charger and batteries  The battery charger allows the simultaneous charge of two batteries. Each battery can power the portable unit for about 4 hours.  Turbine flowmeter, optoelectronic reader and wind cover The turbine flowmeter assembly consists of a bidirectional turbine, an optoelectronic reader and an optional wind cover. The reader measures infrared light interruptions caused by the spinning blade inside the turbine.

  • Page 21: Optoelectronic Reader And Wind Cover

     The pressure regulator is connected to the calibration cylinder for the calibration of the K5 unit. The gas exiting from the regulator enters directly into the unit, which measures its concentration and adjust its correction factors in order to achieve the best accuracy.

  • Page 22: Usb Cable

    There are two different pressure regulators, depending on the cylinder connection: CGA 973 and UNI 4410. USB cable  The USB cable is used to connect the K5 unit to the PC, for downloading tests or for use the device in laboratory mode. Earphones ...

  • Page 23: System Warm-Up

    System warm-up Before using the K5 unit, it must be warmed up for the required amount of time. The warm-up time duration depends on which test is being performed. The following table displays the warm-up time required for each test:...

  • Page 25: Installation

    Installation...

  • Page 26: Before Starting

     Before starting Before operating the K5 you should inspect the equipment and complete the product registration.  Checking the packing contents When opening your product you should assure that the package contains all items listed below. If there are any missing or damaged parts you should contact Cosmed’s technical assistance.

  • Page 27: Optional Modules

     Note: The codes and the packaging shown in the tables below refer to the module if purchased together with the K5 unit. If you wish to purchase an optional module separately from the unit, please contact our sales department or our distributor.

  • Page 28: Options/Accessories/Spare Parts

     Options/Accessories/Spare parts The following options are available with the K5: Code Quantity Description A 860 000 004 Calibration cylinder (5% CO , 16% O , balance N A-870-150-012 Pressure regulator for calibration (CGA 973) A-870-600-001 Pressure regulator for calibration (UNI 4410)

  • Page 29: Preliminary Operations

     Preliminary operations Before operating the system you should make sure that environmental and operational conditions have been met (see Chapter 1). Note: The first time you use the device, charge the battery until they are completely charged (see below). Battery charger ...

  • Page 30: Recalibration

    What is recalibration and why is it needed? As the battery ages and is used, its available capacity shrinks. So, with each cycle, K5 runtime gets a little bit less. A good rule of thumb is that Li-Ion batteries lose 5% capacity per 100 cycles and 5% per year.

  • Page 31: Front Side

    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. To start the warm-up period, connect the battery to the K5 and turn the unit on. Calibration gas cylinder ...

  • Page 32: Install / Replace The O Sensor

    3. Place the O sensor in the dedicated slot 4. Screw it firmly by means of the tool included in the K5 packaging 5. Connect the 3-pin connector to the sensor 6. Replace the cap with the proper key (align the arrow with the symbol) 7.

  • Page 33: Install / Replace The Battery

     Install / replace the battery  Installation 1. Turn off the unit (if on) and unplug it from mains (if connected) 2. Remove the Battery cap with the proper key (align the arrow with the symbol) 3. Remove the yellow protective cap of the battery 4.

  • Page 34: Patient's Preparation

    Patient’s preparation K5 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. There are two different sizes of harness and two different models: the standard one is a harness for adults that can be placed on the back of the subject. Optionally two other harnesses are available: a paediatric harness (to be placed on the back of the child) and a frontal harness.

  • Page 35: Fixing Hr Elastic Belt On The Subject

    5. Fix the K5 unit to the harness through the screw on the bottom of it. Fixing HR elastic belt on the subject To assemble the HR belt: 1. Attach the elastic strap to the HR belt. 2. Adjust the strap to fit tightly and comfortably around the subject’s thorax.
  • Page 36 The electrodes should be placed as follows: 4th intercostal space, to the right of the sternum. 4th intercostal space, to the left of the sternum. Between V2 and V4 electrodes. 5th intercostal space, on the midclavicular line. 5th intercostal space, on the anterior axillary line. 5th intercostal space, on the left midaxillary line.

  • Page 37: Connecting The K5 To The Pc

     Connecting the K5 to the PC K5 unit communicates with the PC via Bluetooth or via USB. Both connections can be used for real-time testing (laboratory mode) or for downloading tests performed in telemetry or holter mode. For a description of these modes, see the chapter K5 operation.

  • Page 38: How To Contact Cosmed

    ITALY Voice: +39 (06) 931.5492 Fax: +39 (06) 931.4580 email: customersupport@cosmed.it Internet: http: //www.cosmed.com Complaints, feedback and suggestions If you have any complaints, feedback or suggestions you may inform us at complain@cosmed.it. 38 - Installation - How to contact COSMED...

  • Page 39: K5 Operation

    K5 Operation...

  • Page 40: K5 Operating Modes

     K5 Operating modes K5 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 •...

  • Page 41: User Interface

    Start the test recording Return to the previous menu / Start the auto-check function (see Auto-check section) Turns the device on or off Return to the Home menu / Enter a marker during a test K5 Operation - User interface- 41...

  • Page 42: Settings

    If the ECG measurement is enabled (ECG Measur), for example if an ECG is connected through the connector • If the SpO measurement is enabled (SPO2 Measur), if an oximeter is connected to the device (via Bluetooth) • If the BTPS correction is enabled (BTPS Enabled) • 42 - K5 Operation - Settings...

  • Page 43: Utility

    Backup the database It allows the user to save the entire database on the SD card. Note: A compatible SD card must be present into the K5 unit. Erase the database It allows the user to erase all the database.
  • Page 44 • Activate the GPS at 10 Hz (if enabled) or at the standard frequency (if disabled) • GPS Data • Show the compass • Synchronize the device time with the GPS time Exit with the EXIT icon. 44 - K5 Operation - Utility...

  • Page 45: Calibration

    (see System maintenance). Perform a turbine calibration 1. Connect the turbine to the optoelectronic reader and this one to the K5 unit 2. Connect the calibration syringe to the turbine 3.

  • Page 46: Reference Gas Calibration

    Note: The cylinder must be open, but the pressure regulator must be closed 2. Connect the sampling line to the Sampling connector on the K5 unit and leave the other end free at the air 3. After flushing the analyzers, the system start calibrating the CO...
  • Page 47 Two factors contribute to the time alignments delay. K5 uses a capillary sampling tube with a pump to draw a continuous gas sample into the analyzers. The gas transport time depends on the dimensions of the tube and on the pump flow rate. Additionally the gas sensors have a response time that must be added to the above delay for calculating the total delay.

  • Page 48: Recommendations For Exercise Testing

    The test should end when the maximum value of the oxygen consumption has been reached and the patient’s response has been established or when the subject requests to stop the test. 48 - K5 Operation - Recommendations for exercise testing...

  • Page 49: Performing A Test

    Note: After turning the device on wait at least the warm-up time before beginning calibration or testing procedures. Test can be performed according to three different modes, as described in K5 operating modes section above. In the following description, the three modes are indicated with H (holter), T (telemetry) and L (laboratory) in the column Mode below.

  • Page 50: Download A Test On The Pc

     Download a test on the PC Tests performed on the K5 can be downloaded on the PC for further analysis and editing. The download of the test is useful in the following cases: if the test is performed in Holter mode, in order to save the test on the PC and to analyze it •...

  • Page 51: Gps

     The GPS is integrated in the K5 unit. but in the following useful information is reported in order to better understand the GPS functioning and to obtain the best results.  GPS initialisation The GPS operates on information gathered from satellites. To gather this information, take your GPS on outside and find large, open area that has a clear view of the sky (a nearby park would work fine).

  • Page 53: System Maintenance

    System maintenance...

  • Page 54: System Maintenance

    All materials used in the construction of the K5 and its accessories are non-toxic and pose no safety risks to the patient or operator. The device should be turned off with the power supply disconnected prior to cleaning, disinfecting and/or inspecting the device.

  • Page 55: Cleaning And Disinfecting

     Cleaning and disinfecting The goal of infection control is to prevent the transmission of infection to patients/subjects and staff during pulmonary function testing. Cleaning and disinfecting instructions should be strictly followed to control infections and assure the safety of the patient. Aspiration of residue, particles and/or contaminated agents could be life threatening.

  • Page 56: Introduction

    Water Quality: tap water is acceptable for use in cleaning COSMED components. COSMED components should be soaked and rinsed in tap water at 22°-43°C to prevent the coagulation of solid substances onto the device and thus facilitate the removal of debris.

  • Page 57: Disinfection

    Remove and examine, extend the soak time for components with dried-on matter, prolonged soaking of components may be detrimental, causing damage to the component surfaces. Refer to the detergent instructions for its usage and soak time. Step 4 Disassembly. Disassemble the item (if necessary) according to the instructions reported in the corresponding section. Step 5 Cleaning.

  • Page 58: Precautions To Take When Cleaning, Disinfecting And Drying The Turbine

    2. Dip it in the disinfectant solution (non-alcoholic based) for about 20 minutes. 3. Rinse the turbine in a vessel, filled of clean water, shaking gently to remove the disinfectant (do not clean the turbine by putting it under running water!). 4.

  • Page 59: Sterilizing The Mask

    1. Dry thoroughly using a soft cloth (preferably sterile) or disposable paper towels. Step 5 Inspection. All components should be visually inspected for cleanliness, proper function and freedom of defects. Visual inspection provides evidence of thorough cleaning and proper functioning of all mask and components. Mask assemblies in poor working condition are hazardous to personnel and patients.

  • Page 60: Sampling Line Maintenance (Permapure)

     Sampling line maintenance (Permapure) Do not bend, squash or deform the sampling line. Any “kink” in the sample line will reduce the internal lumen of the line and affect • accuracy of measurement. Do not keep the sampling line open to the atmosphere, particularly in crowded or smoky environments. Keep the sampling line in sealed •...

  • Page 61: Inspections

     Inspections The equipment requires inspections to be carried out to assure proper electrical and mechanical safety levels. The inspections are recommended after extensive use of the equipment or after a long period of storage in unfavourable environmental conditions. The insulation materials of cables, plugs and any other visible parts should also be inspected. The equipment should be turned off and adapters should be disconnected from the power supply when inspecting the materials.

  • Page 63: Appendix

    Appendix...

  • Page 64: Declaration Of Conformity

    Annex I of the Medical Device Directive 93/42/EEC; are classified in Class IIa; • their design, manufacturing and final checks are performed according the Cosmed’s Quality System, conform to ISO 9001:2008 and • ISO13485:2003 Norms, certified by KIWA CERMET (certificates nr. 387-A and 387-M);...

  • Page 65: Service - Warranty

    Warranty and limitation of liability COSMED provides a one year limited warranty from the date of the original sale of the product. COSMED products are guaranteed to be free from defect upon shipment. Liability for products covered by this warranty is limited to the replacement, repair or issuance of a credit for the cost of a defective product at the discretion of COSMED.
  • Page 66 Net weight • • Reason for repair If repairs are needed, you may contact COSMED at the one of the following addresses: COSMED S.r.l. Via dei Piani di Monte Savello 37 P.O. Box 3 00041 Pavona di Albano - Rome, Italy tel.

  • Page 67: Privacy Information

    Dear Customer, We would like to inform you that your personal data is gathered and will be used by Cosmed Srl in conformity with the requirements of the Italian privacy law (Decreto Legislativo 196/2003). We believe it is important for you to acknowledge how your personal data is handled.

  • Page 68: Disposing Of Electrical Equipment

     Disposing of electrical equipment The device cannot be disposed as unsorted municipal waste. Electronic equipment must be collected separately according to the European Directive 2002/96/EEC. Otherwise it can cause dangerous consequences for the environment and human health. The crossed-out wheeled bin means that the product must be taken to a separate collection when you wish to dispose of it. 68 - Appendix - Disposing of electrical equipment...

  • Page 69: Safety And Conformity

    UNI EN ISO 13485:2012 (Registration n° 387-M Kiwa Cermet) Medical Device Directive (CE mark) MDD 93/42/EEC (Notified Body 0476). Class IIa The K5 complies with the following requirements: FCC (Federal Communications Commission) Part 15 • Operation is subject to the following two conditions: (1) This device may not cause harmful interference, and (2) This device must accept any interference received, including interference that may cause undesired operation.

  • Page 70: Technical Features

     Technical features Portable Unit Display LCD: 3,5” TFT LCD Transflective (320x240) 65k colors high visibility with LED-backlit resistive touch screen Keyboard: waterproof, 4 keys PC Communication: USB, Bluetooth Power supply: Li-Ion rechargeable batteries (autonomy 4 hours) External mains AC/DC adapter Gas measurement: Micro-dynamic mixing chamber (standard) IntelliMET - Intelligent Dual Metabolic Sampling Technology (Mixing Chamber &...

  • Page 71: Power Supply (Battery Charger)

    Power Supply (battery charger) Input: 100V-240V ±10%; 50/60Hz, 1.4A max Output: 24V dc, 2.71A Battery Type: Li-Ion “smart” battery, with LCD charge status Voltage: 7.2V Capacity: 3.1 Ah, 22Wh Environmental Sensors Temperature: -40°C to +50°C Barometer: -600 to +5500m (50 to 110 kPa) Humidity: 0-100% Wireless Connectivity...

  • Page 72: Calculations References

     Calculations references  and VCO "Energy Expenditure and Fuel Selection in Biological Systems: The Theory and Practice of Calculations Based on Indirect Calorimetry and Tracer Methods": M. Elia, G. Livesey, World Rev. Nutr. Diet. Basel, Karger, 1992, vol 70, pp 68-131. "Nutritional Assessment in Critical Care, A Training Handbook": Donald C.

  • Page 73: References

     References Gas Exchange On line computer analysis and breath by breath graphical display of exercise function tests.”; Beaver, Wasserman, Whipp, JAP , 34(1):128-132, 1973 Measurement and analysis of gas exchange during exercise using a programmable calculator”; Sue, Hansen, Blais, Wasserman, JAP, 49(3), 1980:456-461 Principles of exercise testing and interpretation, 2nd edition”;...

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