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.
Each copy ofthe 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

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

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.
7. The cylinder and pressure regulator must be closed before disconnecting the cylinder from the device.
8. Batteries must be removed from the device when it is not used for a long time.
9. Internal backup battery can be replaced by trained authorized personnelonly. The user can only replace the external battery as described in the
dedicated section. Risk of excessive temperatures, fire or explosion.
10. Residue and other contaminants in the breathing circuit pose a safety risk to the patient during testing procedures. Aspiration of contaminants
can be potentially life-threatening. If the recommended disposable anti-bacterial filters are not used, you must disinfect each part coming into
contact with the patient and patient’s breath prior to each test.
11. The cleaning procedures and inspections in the System Maintenance section should be performed prior to each test.
12. This device should not be used in the presence of flammable anaesthetics. This is not an AP or APG device (according to the EN 60 601-1
definitions).
13. The device should not come near any heat or flame sources, flammable or inflammable liquids or gases and explosive properties.
14. The device should not be used in conjunction with any other medical device unless that device is recommended by the manufacturer.
15. The device should be used with a computer with electromagnetic compatibility, CE marking and low radiation emission displays.
16. The PC connected to the device must be compliant with EN 60601-1 bymeans of an isolation transformer.
17. Precautions regarding EMC should be taken prior to installation and canbe noted in the section EMC.
18. Portable and mobile RF communication equipment may interfere with the performance of the device.
19. Only the cable and accessories supplied with the equipment should be used with the device. The use of accessories and/or cables other than
those supplied may result in increased emissions or decreased immunity of the equipment.
20. The device should not be used adjacent to or stacked with other equipment. If this is necessary, you must verify that the device continues to
operate normally in the configuration in which it will be used.
21. The operator cannot simultaneously touch the battery charger and the subject.
22. The TTL ecg connector is not optically insulated: an external device (ecg)can be connected to K5 only through the optional cable C04109-01-12.
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.
24. The graphical symbols used with the device are described below:
Applied part type BF (EN60601-1) Locked
Class II device (EN60601-1)
Unlocked
CE mark (compliance withMDD 93/42) Recording
Device code
ON/OFF
/
Serial number BACK/CHECK key
HR probe / TTL connector HOME/MARKER key
USB connector
Read the user manual
Power connector (dc)
Warning
Getting started - Important notices- 11

Contraindications
Performing forced expiratory manoeuvres involved in spirometry testingmay 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
•Active endocarditis
•Symptomatic severe aortic stenosis
•Decompensated symptomatic heart failure
•Acute pulmonary embolus or pulmonary infarction
•Acute noncardiac disorder that may affect exercise performance or be aggravatedby exercise (eg, infection, renal failure, thyrotoxicosis)
•Acute myocarditis or pericarditis
•Physical disability that would preclude safe and adequate test performance
•Inability to obtain consent
Relative contraindications
•Left main coronary stenosis or its equivalent
•Moderate stenotic valvular heart disease
•Electrolyte abnormalities
•Tachyarrhythmias or bradyarrhythmias
•Atrial fibrillation with uncontrolled ventricular rate
•Hypertrophic cardiomyopathy
•Mental impairment leading to inability to cooperate
•High-degree AV block
Note: Relative contraindications can be superseded if benefits outweigh risks of exercise.
Read carefully the exercise testing chapter.
12 - Getting started - Contraindications

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 flammableanaesthetic mixtures.
COSMED equipment should be operated under normal environmental temperatures and conditions which are defined as follows [IEC 60601-1/EN
60601-1]:
•Temperatures range: 10°C (50°F) and 40°C (104°F).
•Relative humidity range: 30% to 99%.
•Atmospheric Pressure range: altitude from sea level to 4850m.
Note: The K5 Power Supply AC/DC Adapter (C04118-01-30) can be used up to 3000m, the Dual Battery Charger
AC/DC Adapter (C04267-01-10) can be used up to 2000m.
•Avoid operating equipment in the presence of noxious fumes or in dusty environments.
•Do not place units near heat sources.
•Cardiopulmonary resuscitation equipment should be accessible in the case of an emergency.
•Adequate floor space and easy access tothe patient during exercise testing is necessary.
•Adequate ventilation should be maintained in the room the testing is performed.
Getting started - Environmental conditionof use- 13

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. Therefore, its RF emissions are very
low and are not likely to cause any interference in nearby electronic equipment.
RF emissions
CISPR 11
Class B The device is suitable for use in all establishments, including domestic establishments and
those directly connected to the public low-voltage power supply network that supplies
buildings used for domestic purposes.
Harmonic Emission
IEC 61000-3-2
Class A
Voltage
Fluctuations /
Flicker Emission
IEC 61000-3-3
Complies
14 - Getting started - EMC

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. If floors are
covered with synthetic material, the relative humidity should
be at least 30%.
Electrical fast
transient/burst
IEC 61000-4-4
±2 kV for power
supply lines
±1 kV for
input/output lines
±2 kV for power
supply lines
±1 kV for
input/output lines
Mains power quality should be that of a typical commercial or
hospital environment.
Surge
IEC 61000-4-5
±1 kV differential
mode
±2 kV common
mode
±1 kV differential
mode
±2 kV common mode
Mains power quality should be that of a typical commercial or
hospital environment.
Voltage dips, short
interruptions and voltage
variations on power supply
input lines
IEC 61000-4-11
<5% UT
(>95% dip in UT) for
0.5 cycles
40% UT
(60% dip in UT) for 5
cycles
70% UT
(30% dip in UT) for 25
cycles
<5% UT
(>95% dip in UT) for
5 sec
<5% UT
(>95% dip in UT) for
0.5 cycles
40% UT
(60% dip in UT) for 5
cycles
70% UT
(30% dip in UT) for 25
cycles
<5% UT
(>95% dip in UT) for
5 sec
Mains power quality should be that of a typical commercial or
hospital environment. If the user of the device requires
continued operation during power mains interruptions, it is
recommended that the device
be powered from an
uninterruptible power supply or a battery.
Power frequency (50/60
Hz) magnetic field
IEC 61000-4-8
3 A/m 3 A/m
Power frequency magnetic fields should be at levels
characteristic of a typical location in a typical commercial or
hospital environment.
Nota: UTis the a.c. mains voltage prior to application of the test level.
Getting started - EMC- 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
IEC 60601-1
Compliance level Electromagnetic environment – guidance
Conducted RF
IEC 61000-4-6
Radiated RF
IEC 61000-4-3
3 Veff
150 kHz to
80 MHz
3 V/m
80 MHz to
2.5 GHz
3 V
3 V/m
Portable and mobile RF communications equipment should be
used no closer to any part of the device, including cables, than
the recommended separation distance calculated from the
equation applicable to the frequency of the transmitter
Recommended separation distance
d=1.17
P
d=1.17
P
80 MHz to 800 MHz
d=2.33
P
800 MHz to 2.5 GHz
where P
is the maximum output power rating of the
transmitter in watts (W) according to the transmitter
manufacturer and d
is the recommended separation distance in
metres (m).
Field stre
ngths from fixed RF transmitters, as determined by an
electromagnetic site surveya
, should be less than the
compliance level in each frequency rangeb.
Interference may occur in the vicinity of equipment marked
with the following symbol:
Notes:
(1) At 80 MHz, the higher frequency range applies.
(2) These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures,
objects and people.
aField strengths from fixed transmitters, such as base
stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio,
AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment
due to fixed RF transmitters, an
electromagnetic site survey should be considered. If the measured field strength in the location in which the
device is used exceeds the applicable RF compliance level above, the device should be observed to verify normal operation. If abnormal
performance is observed, additional measures may be necessary, such as reorienting or relocating the device.
bOver the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m
16 - Getting started - EMC

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.
Rated maximum output
power of transmitter
(W)
Separation distance according to frequency of transmitter
(m)
150 kHz to 80 MHz
d=1.17
P
80 MHz to 800 MHz
d=1.17
P
800 MHz to 2.5 GHz
d=2.33
P
0.01 0.12 0.12 0.23
0.1 0.37 0.37 0.74
1 1.17 1.17 2.33
10 3.70 3.70 7.38
100 11.70 11.70 23.33
For transmitters rated at a maximum output power not listed above, the recommended separation distance d in metres (m) can be determined
using the equation applicable to the frequency of the transmitter, where P is the maximum outp
ut power rating of the transmitter in watts (W)
according to the transmitter manufacturer.
Notes:
(1) At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
(2) These guidelines may not apply in all situations. Electromagnet
ic propagation is affected by absorption and reflection from structures,
objects and people.
Getting started - EMC- 17

Overview of the manual
This manual is organized in the following chapters:
Getting started. Describes the intended use of the device, how to properlyuse 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. Contains information regarding the warranty, treatment of personal data, reference standards, technical features, predicted values and
bibliographic references.
Software and test execution are described in the Software Manual. We recommend to read both manuals before using this device.
18 - Getting started - Overview of the manual

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. The PU contains the O2and CO2analyzers, sampling pump, transmitter, barometric sensors and electronics. It is
powered by the rechargeable battery inside it.
The K5 is provided with a 3.5” touch-screen LCD display with LED-back-lit TFT for optimal viewing in all lighting conditions. The LCD user interface
allows full control on all features under any environment. The touchscreen technology is resistive, so it can be used in outdoor conditions with
either gloves or wet fingers.
Bluetooth PC module (option)
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
up to 900 meters in line-of-sight)
Getting started - System overview- 19

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. The device may be used to measure a wide flow range and is not
affected by ambient conditions (pressure, humidity, room temperature, exhaled gas composition). Daily calibration of the turbine is not necessary,
but calibrations should be performed regularly to assure accurate measurements.
The wind cover is mounted on the reader and it is used for protecting the turbine from the wind (for outdoor applications), in order to avoid errors
due to the wind entering into the turbine.
The flowmeter can be used for all tests.
Face mask and head cap
The exercise test masks are made of silicone and may be reused after proper disinfection (see the chapter Maintenance).
These blue masks are available in different sizes and should be assembled the included head cap as shown in the chapter Exercise testing.
20 - Getting started - System overview