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.
Table of contents Table of contents .................................................................................................................................................................................. 3 Getting started..................................................................................................................................................................................... 9 Important notices ............................................................................
Charging batteries .......................................................................................................................................................................................29 Recharge time .............................................................................................................................................................................................29 Recalibration ........................................................................
Control Panel .............................................................................................................................................................................................. 43 Navigation .................................................................................................................................................................................................. 43 Calibration...................................................................
Disinfecting the mask ..................................................................................................................................................................................58 Sterilizing the mask .....................................................................................................................................................................................59 Reassembling the mask and components ...................................................................
Sub-maximal exercise testing ..................................................................................................................................................................... 73 Oximeter .....................................................................................................................................................................................................
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.
6. You should ensure that the pressure regulator is chemically and physically compatible with the intended gas cylinder before installation. The regulator must be properly connected. Note the pressure gauge for the regulator. The physical condition of the regulator, threads and fittings should also be examined prior to installation. Any dust or dirt on the regulator or cylinder valve should be removed with a clean cloth. The regulator should not be installed on a cylinder valve if grease or oil is present.
Contraindications Performing forced expiratory manoeuvres involved in spirometry testing may be contraindicated in certain conditions.
Environmental condition of use COSMED units should not be operated near explosive substances. 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.
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 – guidance RF emissions CISPR 11 Group 1 The device uses RF energy only for its internal function.
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 IEC 60601-1 Compliance level Electromagnetic environment – guidance Electrostatic discharge (ESD) IEC 61000-4-2 ±6 kV contact ±8 kV air ±6 kV contact ±8 kV air Floors should be wood, concrete or ceramic tile.
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.
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.
Overview of the manual This manual is organized in the following chapters: 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. Appendix.
System overview The K5 consists of the following main parts: • Portable unit • Batteries • Battery charger • Flowmeter • Additional external sensors and devices (HR, oximeter, face masks, etc.). Some of the parts described below are options and are not included in the standard packaging. Portable unit It is fixed to the patient during the test by an anatomic harness. In this configuration, the distance between subject’s body and the transmitting antenna is more than 25mm.
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.
Optoelectronic reader and wind cover The optoelectronic reader HR probe The HR probe consists of two parts that can be fixed by means of automatic buttons: the elastic belt and the transmitter. The belt should be placed as close as possible to the K5 unit to acquire the most effective communication signal. Oximeter (option) The oximeter probe should be placed on the patient’s finger to measure oxygen saturation at rest or during exercise.
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 The earphones are used for communicating with the subject in outdoor telemetric applications.
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: Test Warm-up time (minutes) CPET (exercise test) 45 During the warm-up period the device must be powered on, but the software does not need to be open. Calibration and/or testing procedures should never be performed until the warm-up period has been completed.
Installation
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. Device packaging The device is made of a main unit and one or more optional modules.
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.
Options/Accessories/Spare parts The following options are available with the K5: Code Quantity Description A 860 000 004 1 Calibration cylinder (5% CO2, 16% O2, balance N2) A-870-150-012 1 Pressure regulator for calibration (CGA 973) A-870-600-001 1 Pressure regulator for calibration (UNI 4410) C00600-01-11 1 Calibration syringe 3 litres C04108-01-06 1 HR Polar receiver C04109-01-12 1 Optoisolated HR interface (for TTL ecg) A-497-500-004 1 Battery charger (cigar light adapter) C043
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 Note: The USB connection (to PC or any other USB devices) doesn’t charge the battery. Safety warnings 1. 2. 3. 4. 5. 6. Do not expose the charger or power supply to water or liquids. The case it not sealed.
Recalibration Recalibration consists of a charge, followed by a calibration discharge. Finally the battery is given a regular charge. A calibration cycle is faster if the battery is fully charged to begin with. If fuel gauge recalibration is needed, the red LED on the charger will flash upon insertion of the battery. The user can either calibrate the fuel gauge and charge the battery, or just charge the battery.
Front side 1 2 5 3 4 6 1. Rec key (starts the data acquisition) 2. BACK/CHECK key (returns to the previous menu or perform a system check) 3. ON/OFF key (turns the device on or off) 4. HOME/MRK key (returns to the home menu or enter a marker during the test) 5. LCD display 6. Humidity sensor Bottom side In the bottom side is located a threated slot for connection to a tripod or to the harness.
Install / replace the O2 sensor Note: The unit is supplied without the O2 sensor installed. Before using the device, please install the O2 sensor according to the instructions below. The included O2 sensor has an expiration date printed on the package as well as on the sensor itself indicating the latest date for the installation. Expected Sensor Lifespan is about 12 months after the package is opened. COSMED offers a 6 month warranty on the O2 sensor from the date of purchase.
Install / replace the battery Installation 1. 2. 3. 4. 5. Turn off the unit (if on) and unplug it from mains (if connected) Remove the Battery cap with the proper key (align the arrow with the symbol) Remove the yellow protective cap of the battery Place the battery in the dedicated slot. Replace the cap with the proper key (align the arrow with the symbol) Replacement 1. Turn off the unit (if on) and unplug it from mains (if connected) 2.
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.
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. 3. Secure the strap tightly around the chest (below the nipple line) and lock the buckle. 4. You may wet the grooved electrode areas with saliva, contact lens solution or an alternative saline solution to help it stick to the subject.
The electrodes should be placed as follows: V1 4th intercostal space, to the right of the sternum. V2 4th intercostal space, to the left of the sternum. V3 Between V2 and V4 electrodes. V4 5th intercostal space, on the midclavicular line. V5 5th intercostal space, on the anterior axillary line. V6 5th intercostal space, on the left midaxillary line. Limb electrodes for the arms should be placed in the subclavicular areas.
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. Note: The USB connection (to PC or any other USB devices) doesn’t charge the battery.
How to contact COSMED You may contact the manufacturer directly at the following address for information: COSMED S.r.l. Via dei Piani di Monte Savello, 37 00041 - Albano Laziale (RM) 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.
K5 Operation
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 • Telemetry Data Transmission • Laboratory Station Holter Data Recorder Using the system in the field without the PC, you can store data in the unit.
User interface The user interface is based on a LCD touch screen display and four keys. The display is resistive in order to allow the user to use it also with gloves, wet fingers, etc. To select an icon on the screen, please touch it with a finger or with a touch screen pen (not supplied). To select a function carried out by a key, please press the corresponding key.
Settings The Settings menu is accessible by pressing the related icon from the Home menu. International The International screen allows the user to: • Set the time zone (Time zone), the current date (Date) and the current time (Time). See below for more information. • Synchronize the internal clock with the GPS time (Sync with GPS). If deselected, you can change the time according your needs, otherwise the time will be synchronized with the GPS. The last choice is more precise and it is recommended.
Utility The Utility menu is accessible by pressing the related icon from the Home menu. Database The Database screen allows the user to: • Search into the database (Search) • Backup the database on an external SD card (Save DB to SD) • Erase the database (Erase DB) • Consult the database status (DB status) Search into the database It allows the user to search into the database for a subject, a test date or a test. Backup the database It allows the user to save the entire database on the SD card.
The UP and DOWN arrows allow you to navigate through the different pages of the panel. Above the data, some keys are shown for: • Enable/disable the GPS • Delete the last GPS data in cache (for new fixing not starting from a previous position) • 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.
Calibration The Calibration menu is accessible by pressing the related icon from the Home menu. Regular calibration is necessary to assure your system is acquiring reliable measurements. Calibration frequency The table below shows a summary with the calibration intervals recommended by COSMED.
The Delay calibration, recommended to be carried out once per week or whenever the sampling line is replaced, is necessary to measure accurately the time necessary for the gas sample to pass through the sampling line before being analyzed. Note: Cellular phones should be turned off to eliminate potential electrical interferences. Reference Gas calibration The software allows to automatically calibrate zero, gain and alignments of the gases sensors.
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.
Recommendations for exercise testing Evaluation of the cardiorespiratory function Exercise creates an increased demand of energy and gas exchange which must be supplied by the cardiovascular and respiratory systems. The increase in metabolic rate during exercise creates an increase of oxygen in the muscles. The muscles also generate excess CO2 which must be removed to avoid lactic acid build up.
Performing a test Before starting the exercise test, type in the new patient information or choose the desired patient from the list of patients in the database. The name of the active patient will be displayed on the status bar. 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.
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 • if the test is performed in Telemetry mode, and some interferences occurred during the test. In fact, in this case some breaths could be lost.
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). The GPS needs to receive at least three strong satellite signals to find your location.
System maintenance
System maintenance Any service operations not specified in this user manual should be only performed by qualified personnel in accordance with the service handbook. Rubber mouthpieces, face masks, breathing valves and the other parts are not shipped sterile. These should be disinfected before using according to the cleaning instructions in this section. 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.
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. The recommendations in the following section are retrieved from Miller MR, Crapo R, Hankinson J, et al.
Warning: Particular precautions should be taken when testing patients with high risk communicable diseases (i.e. Tuberculosis, Multidrug Resistant Staphylococcus infections, etc.). When such conditions are present the clinical need for performing the test should justify the risks. When performing the disinfection: • Do not use alcohol or other liquids containing Gluteraldehyde on the exterior surface of the equipment.
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. Protective attire is required for personnel handling contaminated items.
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. In order to let it dry, please shake it in air and/or connect it to the calibration syringe and perform some strokes. 5. After cleaning the turbine, check if the turbine propeller rotates freely even with a low speed air flow. 6. Connect the turbine to the reader.
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. 1. Visually inspect all components for cleanliness.
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 plastic bag in a dark cool and dry place. If saliva enters the tube it should be replaced immediately.
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.
Appendix
Declaration of conformity COSMED S.r.l.
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.
Gross weight • 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. +39 (06) 9315492 fax +39 (06) 9314580 E-mail: customersupport@cosmed.it • USA contact: COSMED USA Inc 2211 North Elston, Suite 305 Chicago IL 60614 USA Phone: +1 (773) 645-8113 Fax: +1 (773) 645-8116 email: usa.sales@cosmed.
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.
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.
Safety and conformity Safety IEC 60601-1/EN 60601-1; The complete classification of the device is as follows: • Class II type BF • Protection against water penetration: IP66 • Non sterile device • Device not suitable in the presence of flammable anaesthetics • Continuous functioning equipment EMC The system meets the Standard IEC 60601-1-2.
Technical features Portable Unit Display LCD: Keyboard: PC Communication: Power supply: Gas measurement: Dimensions: Weight: CPU: Storage capacity: Additional memory: 3,5” TFT LCD Transflective (320x240) 65k colors high visibility with LED-backlit resistive touch screen waterproof, 4 keys USB, Bluetooth Li-Ion rechargeable batteries (autonomy 4 hours) External mains AC/DC adapter Micro-dynamic mixing chamber (standard) IntelliMET - Intelligent Dual Metabolic Sampling Technology (Mixing Chamber & Breath
Power Supply (battery charger) Input: Output: 100V-240V ±10%; 50/60Hz, 1.4A max 24V dc, 2.71A Battery Type: Voltage: Capacity: Li-Ion “smart” battery, with LCD charge status 7.2V 3.1 Ah, 22Wh Environmental Sensors Temperature: Barometer: Humidity: -40°C to +50°C -600 to +5500m (50 to 110 kPa) 0-100% Wireless Connectivity Telemetry (standard): Telemetry (optional): Wireless Device Interface: ANT+ Module (optional): Other: Bluetooth 2.
Calculations references VO2 and VCO2 "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.
References Gas Exchange On line computer analysis and breath by breath graphical display of exercise function tests.
