Cosmed K5 User manual

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 ofCOSMED Srl.
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K5 User manual, I Edition
05/2015
Copyright © 2014 COSMED
COSMED Srl - Italy
http://www.cosmed.com
Part N. C04255-02-91

Table of contents
Table of contents..................................................................................................................................................................................3
Getting started.....................................................................................................................................................................................9
Important notices..............................................................................................................................................................................................10
Intended use...............................................................................................................................................................................................10
Warnings ....................................................................................................................................................................................................10
Contraindications ..............................................................................................................................................................................................12
Contraindications for Exercise testing..........................................................................................................................................................12
Absolute contraindications..........................................................................................................................................................................12
Relative contraindications...........................................................................................................................................................................12
Environmental condition of use.........................................................................................................................................................................13
EMC...................................................................................................................................................................................................................14
Overview of the manual.....................................................................................................................................................................................18
System overview ...............................................................................................................................................................................................19
Portable unit...............................................................................................................................................................................................19
Bluetooth PC module (option).....................................................................................................................................................................19
Battery charger and batteries......................................................................................................................................................................20
Turbine flowmeter, optoelectronic reader and wind cover..........................................................................................................................20
Face mask and head cap..............................................................................................................................................................................20
Optoelectronic reader and wind cover.........................................................................................................................................................21
HR probe.....................................................................................................................................................................................................21
Oximeter (option).......................................................................................................................................................................................21
Pressure regulator for calibration (option) .................................................................................................................................................. 21
USB cable....................................................................................................................................................................................................22
Earphones...................................................................................................................................................................................................22
O2sensor.....................................................................................................................................................................................................22
Power supply ..............................................................................................................................................................................................22
System warm-up...............................................................................................................................................................................................23
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
Options/Accessories/Spare parts........................................................................................................................................................................28
Preliminary operations......................................................................................................................................................................................29
Battery charger...........................................................................................................................................................................................29
Safety warnings..........................................................................................................................................................................................29
Use the charger...........................................................................................................................................................................................29

Charging batteries.......................................................................................................................................................................................29
Recharge time.............................................................................................................................................................................................29
Recalibration...............................................................................................................................................................................................30
What is recalibration and why is it needed?.................................................................................................................................................30
Portable unit ...............................................................................................................................................................................................30
Powering.....................................................................................................................................................................................................30
Top side .......................................................................................................................................................................................................30
Front side ....................................................................................................................................................................................................31
Bottom side.................................................................................................................................................................................................31
Installation..................................................................................................................................................................................................31
Turning on and off the unit..........................................................................................................................................................................31
Warm up .....................................................................................................................................................................................................31
Calibration gas cylinder ...............................................................................................................................................................................31
Install / replace the O2sensor .............................................................................................................................................................................32
Installation..................................................................................................................................................................................................32
Replacement ...............................................................................................................................................................................................32
Install / replace the battery................................................................................................................................................................................33
Installation..................................................................................................................................................................................................33
Replacement ...............................................................................................................................................................................................33
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)...............................................................................................................................................35
Connecting the K5 to the PC...............................................................................................................................................................................37
Bluetooth connection..................................................................................................................................................................................37
USB connection ...........................................................................................................................................................................................37
How to contact COSMED.....................................................................................................................................................................................38
Complaints, feedback and suggestions........................................................................................................................................................38
K5 Operation...................................................................................................................................................................................... 39
K5 Operating modes...........................................................................................................................................................................................40
Holter Data Recorder ...................................................................................................................................................................................40
Telemetry Data Transmission.......................................................................................................................................................................40
Laboratory Station.......................................................................................................................................................................................40
User interface.....................................................................................................................................................................................................41
The four keys ...............................................................................................................................................................................................41
Settings..............................................................................................................................................................................................................42
International ...............................................................................................................................................................................................42
System ........................................................................................................................................................................................................42
IntelliMET (option) ......................................................................................................................................................................................42
Utility.................................................................................................................................................................................................................43
Database .....................................................................................................................................................................................................43
Search into the database .............................................................................................................................................................................43
Backup the database ...................................................................................................................................................................................43
Erase the database ......................................................................................................................................................................................43
Consult the database status.........................................................................................................................................................................43
4 - Table of contents - Important notices

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
Room Air calibration ...................................................................................................................................................................................46
Delay calibration.........................................................................................................................................................................................46
Recommendations for exercise testing..............................................................................................................................................................48
Evaluation of the cardiorespiratory function................................................................................................................................................ 48
Precautions.................................................................................................................................................................................................48
Laboratory..................................................................................................................................................................................................48
Ending the test............................................................................................................................................................................................48
Preparing the patient..................................................................................................................................................................................48
Before testing .............................................................................................................................................................................................48
Patient assent.............................................................................................................................................................................................48
Ending the test............................................................................................................................................................................................48
Performing a test...............................................................................................................................................................................................49
Download a test on the PC.................................................................................................................................................................................50
GPS....................................................................................................................................................................................................................51
GPS initialisation.........................................................................................................................................................................................51
System maintenance .......................................................................................................................................................................... 53
System maintenance.........................................................................................................................................................................................54
Cleaning and disinfecting ..................................................................................................................................................................................55
Prevention of infection transmission...........................................................................................................................................................55
Transmission to technicians ........................................................................................................................................................................55
Cross-contamination...................................................................................................................................................................................55
Tuberculosis................................................................................................................................................................................................55
Haemoptysis and oral lesions......................................................................................................................................................................55
Other known transmissible infectious diseases............................................................................................................................................55
Disposable in-line filters..............................................................................................................................................................................55
Other precautions and warnings .................................................................................................................................................................55
Introduction................................................................................................................................................................................................56
Cleaning......................................................................................................................................................................................................56
Cleaning Agents/supplies............................................................................................................................................................................56
Standard cleaning procedure ......................................................................................................................................................................56
Disinfection.................................................................................................................................................................................................57
Preparing the disinfecting solution .............................................................................................................................................................57
The turbine flowmeter................................................................................................................................................................................57
Cleaning the turbine ...................................................................................................................................................................................57
Disinfecting the ID28 turbine ......................................................................................................................................................................57
Precautions to take when cleaning, disinfecting and drying the turbine...................................................................................................... 58
VO2max mask..............................................................................................................................................................................................58
Disassembling the mask..............................................................................................................................................................................58
Cleaning the mask ......................................................................................................................................................................................58
Table of contents - Important notices - 5

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
Service - Warranty..............................................................................................................................................................................................65
Warranty and limitation of liability..............................................................................................................................................................65
Return goods policy for warranty or non warranty repair.............................................................................................................................65
Repair Service Policy....................................................................................................................................................................................65
Privacy Information............................................................................................................................................................................................67
Personal data treatment and purposes........................................................................................................................................................67
How your personal data is treated ...............................................................................................................................................................67
Consent.......................................................................................................................................................................................................67
Holder of the personal data .........................................................................................................................................................................67
Customer rights...........................................................................................................................................................................................67
Disposing of electrical equipment ......................................................................................................................................................................68
Safety and conformity........................................................................................................................................................................................69
Safety..........................................................................................................................................................................................................69
EMC.............................................................................................................................................................................................................69
Telemetry....................................................................................................................................................................................................69
Quality Assurance........................................................................................................................................................................................69
Medical Device Directive (CE mark)..............................................................................................................................................................69
FCC ..............................................................................................................................................................................................................69
Technical features..............................................................................................................................................................................................70
Portable Unit...............................................................................................................................................................................................70
Battery charger Unit ....................................................................................................................................................................................70
Flowmeter...................................................................................................................................................................................................70
Oxygen Sensor (O2)......................................................................................................................................................................................70
Carbon Dioxide Sensor (CO2) .......................................................................................................................................................................70
Humidity absorber.......................................................................................................................................................................................70
Power Supply (mains AC/DC adapter)..........................................................................................................................................................70
Power Supply (battery charger)...................................................................................................................................................................71
Battery ........................................................................................................................................................................................................71
Environmental Sensors................................................................................................................................................................................71
Wireless Connectivity ..................................................................................................................................................................................71
Navigation & Motion Sensors.......................................................................................................................................................................71
Calculations references.......................................................................................................................................................................................72
VO2and VCO2...............................................................................................................................................................................................72
Anaerobic Threshold (modified V-Slope) .....................................................................................................................................................72
References...................................................................................................................................................................................................72
Oxygen Kinetics...........................................................................................................................................................................................72
References .........................................................................................................................................................................................................73
Gas Exchange...............................................................................................................................................................................................73
Indirect Calorimetry.....................................................................................................................................................................................73
6 - Table of contents - Important notices

Sub-maximal exercise testing.....................................................................................................................................................................73
Oximeter.....................................................................................................................................................................................................73
Table of contents - Important notices - 7

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.
One difficulty to achieve this goal during sport that cannot be simulated in the laboratory is to use a reliable and valid portable system to measure
VO2and VCO2in a field setting.
Such a portable apparatus may also be useful to determine theenergy 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 olderand animals within compatible measurement ranges.
Note: When used on animals, K5 is not considered a medical device according to the current regulations. In case,
please contact COSMED in order to obtain further information about the use of the device and accessories (masks,
flowmeters, etc…).
It is to be used by physicians orby trained personnel on a physician responsibility.
Note: K5 have not to be intended as a monitoring device. It is not intended to be used for continuous surveillance of
vital physiological processes, but only to obtain readings of different physiological signals and parameters in routine
check-ups.
Caution: Federal law restricts this device to be sold by the order of a physician.
This equipment is intended to be used for the following applications:
•Formulating of a lung pathology diagnosis.
•Assisting with human physiology studies.
•Contributing to sports medicine applications.
COSMEDSrl is not responsible for incidents which occur due to improper use of this device. Examples include:
•Operation of the device by unqualified individuals.
•Use of the device not indicated by this manual.
•Not complying with the precautions and instructions described in this manual.
Warnings
The device, program algorithms and presentation of the measured data has been developed in accordance with the specifications outlined by the
ATS (American Thoracic Society) and ERS (European Respiratory Society). Additional international references have also been applied where
applicable. All bibliography references are reported in the Appendix.
This User Manual has been developed in accordance with the Class IIa European Medical Device Directive requirements.
The precautions listed below should be noted before operating the device to ensure the safetyof the user.
1. This User Manual should always be available as a reference when testing.
2. The following standards should be applied to ensure the accuracy of individual test results:
•Accessories should only be used as described in this manual. The manufacturer does not warranty any non-authorized accessories used by
the end user. The manufacturer may offer suggestions while using such accessories and the complications they could cause;
•Repairs or modifications of the device should ONLY be carried out by qualified and trained personnel;
•Environmental and electrical conditions in which the device operates shouldbe in compliance with the specifications of this manual.
•Equipment maintenance, inspections, disinfection and cleaning should be as described in this manual.
3. Before powering on the system, the power cords and plugs should be inspected. Damaged electrical parts must be replaced immediately by
authorized personnel.
4. Large gas cylinders provided by the manufacturer or purchased by the customer must be secured with cylinder safety chains or safety stands as
required by local law.
5. After removing the protective cap of the cylinder you should inspect the cylinder valve for damaged threads, dirt, oil and/or grease. Any dust or
dirt should be removed and the cylinder should not be used if oil or grease is present.
10 - Getting started - Important notices