Kinvent K-Myo User manual

K-Myo Electromyograph
User
Guide

K- MYO User Manual
This manual concerns the K-Myo product. The information content of this manual belongs
to KINVENT, and is provided only for the purpose of operating K-Myo and software. This
manual is subject to modifications. The latest version is available on
https://quickstart.k-invent.com/
The advice given in this manual is intended to supplement, not supersede, the normal
safety requirements prevailing in the user’s country
Manufacturer
KINVENT Biomécanique SAS
Cap omega, Rond-Point Benjamin Franklin,
34000 Montpellier, FRANCE
[phone]
[e-mail],
www.k-invent.com
©Copyright 2023 KINVENT Biomécanique SAS.
KINVENT Biomécanique, K- SENSORS, K-Myo, its logos, and other KINVENT brand
trademarks and made names are registered trademarks of KINVENT Biomécanique
SAS.
All rights reserved. This material may not be reproduced by any means, physical or
electronic, without prior written consent of KINVENT Biomécanique
Trademarks
Trademarks and labels used in this document are property of their respective owners
This product is protected by granted patents, pending patent applications and
their corresponding national rights.
Revision: 3
Last revision: 2023-02-11
2© 2023 KINVENT Biomecanique KM2023C_EN

K- MYO User Manual
Graphic Symbol
The sensors comply with
electromagnetic regulations as laid
out by the Federal
Communications Commission.
Sensor will not work when
connected to AC outlet
European Conformity
MDR 2017/ 745
Class II Electrical Equipment
IEC 60878
Direct Current IN
An ISO 15223 symbol Indicating
upper & lower temperature limits
for operation, transport, and
storage
Recyclable Packaging Box
Humidity limitation. Indicates the
range of humidity to which the
medical device can be safely
exposed.
Keep Dry. Indicates a medical
device that needs to
be protected from moisture.
Atmospheric pressure limitation.
Indicates the range of
atmospheric pressure to which
the medical device can be safely
exposed.
Sensor is provided nonsterile
Non Ionizing radiation
Attention, See Instructions for use
Do not dispose of the units in
normal household waste. Dispose
products in accordance with local
regulations
Waste Electrical and Electronic
Equipment (WEEE) logo
Type BF applied part - External
Body only , Floating- No earth
connection
General warning
Indicates the manufacturer’s serial
number so that a specific
medical device can be identified
General Notice
Indicates the medical device legal
manufacturer, as defined in EU
Directives 90/385/EEC, 93/42/EEC
and 98/79/EC
Bluetooth logo. The utilizes a
Bluetooth LE radio for wireless
communications
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K- MYO User Manual
Contents
Graphic Symbol 3
Contents 4
Introduction 5
About us 5
Safety Information 5
Photosensitive seizure warning 5
K-Physio application 1.19 6
Installation the Application on the Host
Device 7
First Login 7
Intended use 9
CONTRAINDICATIONS 9
Safety precautions 10
Replaceable Parts 12
General Operating Conditions 13
Operating Environment 13
Storage, Packaging and
Transportation 13
Calibration 13
Cleaning 14
Interface 15
LED States 16
K-Myo 17
Description 17
Benefits 17
Usability Data 17
Technical Features 18
Get Started 19
Accessories 20
Content of the Commercial Package 21
Preparation for measurement and best
practices 21
Troubleshooting 23
Sensor difficulties 23
Connectivity difficulties 24
Legal information 25
Warranty Terms 25
European Union 25
Other countries 25
Obligations of the User 25
Service policy 26
Waste Electrical and Electronic
Equipment (WEEE) Policy 26
Declaration of Conformity 27
FCC information 32
Canada 32
Japan 32
Switzerland 33
United Kingdom 33
Contact Information 33
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K- MYO User Manual
Introduction
Thank you for purchasing the K-Myo.
K-Myo is part of the product line developed by KINVENT to objectively quantify
rehabilitation.
About us
KINVENT is specialized in the design and manufacturing of biomechanics equipment. Our
strength is that we can conceive and implement solutions to any challenge in sports
biomechanics and physical rehabilitation. Our products include ready-to-use force plates,
inertial wireless sensors, simulators and various custom-made applications.
Find more information on our products at www.k-invent.com.
Safety Information
The instructions and safety information in this user manual must be followed to ensure
safe operation of the K-Myo. Please note that if the equipment is used in a manner not
specified by KINVENT, the protection provided by the equipment may be impaired.
The following types of safety information appear throughout the Manual. Details are given
in the format as shown below:
The term WARNING is used to inform you about situations that could
result in serious damage to the device or other part of the System and
to the environment.
The term CAUTION is used to inform you about situations that could
result in damage to the device that affect the measurement results or
pose a risk to the safety of the patient/user or the operator.
The term NOTICE is used to indicate information considered important
but not hazard related (e.g., security messages, maintenance and
cleaning guidelines)
Photosensitive seizure warning
A very small percentage of people may experience a seizure when exposed to certain
visual images, including flashing lights or patterns that may appear in video games. Even
people who have no history of seizures or epilepsy may have an undiagnosed condition
that can cause these “photosensitive epileptic seizures” while watching video games.
These seizures may have a variety of symptoms, including altered vision, eye or face
twitching, jerking or shaking of arms or legs, disorientation, confusion, or momentary loss
of awareness. Seizures may also cause loss of consciousness or convulsions that can lead
to injury.
Immediately discontinue playing and consult a doctor if you experience any of these
symptoms.Parents should watch for or ask their children about the above symptoms.
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K- MYO User Manual
K-Physio application 1.191
Kinvent Physio is the only app you will need for all your Kinvent Sensors. All tutorials for
the Kinvent Physio app are available online at: Kinvent.link/quickstart
Minimum Requirements: Android 6.0+ or iOS 11.0+, 2GB of RAM, Bluetooth Low Energy
4.2+, 5'' (12.7cm) Screen diagonal
Recommended: Android 8.0+ or iOS 16.0+, 4GB of RAM, Bluetooth Low Energy 5.0+, 6.5''
(16.5 cm) Screen diagonal
1Latest version may differ on the store
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K- MYO User Manual
Installation the Application on the Host Device
Download the App from Google Play for
Android Devices or App Store for iOS devices
Follow the Instruction registration on the App
Connect the Device with the App Via BLE
First Login
The K Physio App will require an initial registration and some information regarding the
operator’s specialty and profile to help ensure proper use.
You need to connect the K SENSORS and K-Myo with compatible Bluetooth® Low Energy
(BLE) devices to store, analyze and view the measurement data. These host devices HD
can be, for example mobile devices running respective host applications (K Physio) for
data visualization.
The sensors can be registered in the K Physio App in order to be easily identified when
starting an exercise.
You can register the devices with multiple host devices, but only one connection can be
active at a time.
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K- MYO User Manual
Full patient file
Fill in the patient’s pathology information
to guide care and make their file available
to all healthcare professionals in your
office.
Personalized reports
Synthesize your rehabilitation results with
the multiple export module.
Standard premium evaluations
Take a scientific approach to validated
standard protocols: CMJ, Drop jump, Squat
jump, McCall test, ASH test, squat analysis,
Romberg, test profile strength, DSI, EVA,
max strength, IMPT, antagonist ratio,
posture analysis.
K-apture
Film your patient’s movement and
synchronize it with every Kinvent Physio
evaluations. Carry out qualitative analysis
to integrate in your reports.
MyKinvent
Give your patient agency in their
rehabilitation by giving them access to
their own data.
Kinvent Connect
Centralize all your data in one place and
access it from any device: smartphone,
tablet, computer, etc.
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K- MYO User Manual
Intended use
The K-Myo is intended to be used by trained professionals to assist with qualitative
evaluating the muscle activity
The K-Myo may be used by medical professionals at healthcare facilities or at patient
homes. The K-Myo by KINVENT must be operated by personnel familiar with
electromyography and have the appropriate training
K-Myo is
●Medical Electrical Equipment
●Internally Powered Equipment (Battery operated)
●With Type BF Applied Part
●Continuous operation
●Not suitable for operation in an oxygen rich environment
The expected service life in normal use is 5 years
Replace the device after ending the expected service life or earlier if one of the follows
occur:
●otherwise instructed or
●the harsher than normal operating conditions have caused deterioration of the
essential features or
●if any damage to the device is observed (e.g., any cracks or structural damage).
●See paragraph for recycling guidance.
CONTRAINDICATIONS
The K-Myo is contraindicated under the following:
- On or near open wounds
- Patients having severe osteoporosis
- On or near burned tissue
- On or near the eye
- On or near fractures
- Not to be used for any purpose other than indicated
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K- MYO User Manual
Safety precautions
The safety information must be read thoroughly and understood before starting the work
with K-Myo
●Take care of the strong attachment or hold of each sensor.
●Do not dispose of the K-Myo sensor in fire.
●K-Myo contains lithium-polymer batteries. Do not dispose of the batteries with
household waste
●The K-Myo is not protected against ingress of liquids. Keep sensors dry. Do not
immerse the K-Myo or their accessories in water.
●The K-Myo and accessories are provided non-sterile and are not compatible with
autoclave or other sterilization techniques. Do not autoclave.
●Use only a factory supplied wall pack power supply, charger. Use of another charger
may result in electrical shock or equipment damage.
●K-Myo is not intended for use while attached to a wall pack power supply or a
charger. Never attempt to operate the instrument while it is connected to the
charger as electrical shock or damage to the instrument may occur.
DO NOT USE ON Patients with Silver allergies.
DO NOT USE on irritated skin or open wounds.
Immediately discontinue device use if skin irritation or discomfort
occurs.
●Only use the device in your existing environment during your daily routine
activities. Do not use the device during enhanced or irregular activities or outside
your natural environment, unless specifically instructed otherwise by your doctor or
physical therapist.
●Do not drive or operate heavy machinery while wearing the device.
●Users with disabilities (e.g neurological disorders, osteoporosis), which may cause
contraindications, or users for whom exercise may be extremely dangerous, must
take precaution to ensure their safety when using the device (e.g., supervision, etc.).
●Do not use the device if you suspect that it is faulty or has been damaged. Do not
try to repair the device on your own.
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K- MYO User Manual
●Report any change in your medical condition that is related to the diagnosis or
treatment to your doctor or physical therapist.
●Do not give, sell, rent or allow the use of your device to or by another person.
●Stop the use of the system immediately if parts are damaged or if a change in the
performance is observed.
●Stop the use of the system immediately if an allergic reaction is observed.
●Do not modify this system without prior written authorization of the manufacturer.
If this system is modified, appropriate inspection and testing must be conducted to
ensure continued safe use of the system.
●Always consult your doctor if you have a medical condition and before beginning a
program.
●Always consult your doctor before using the device if you have a pacemaker or
other implanted device. Although several implanted pacemaker manufacturers
state the risk associated with the simultaneous use is low, it is essential to consult a
doctor who knows the exact type and model of the implanted device in question
before using the system. In any case keep the device at least 15cm (6”) away from
the implanted device.
●Do not use the device during magnetic resonance imaging (MRI), unless
specifically approved by the personnel operating the MRI equipment. The battery
inside the device is sensitive to magnetic fields.
●The device is not for multiple users if consequences from possible cross
contamination may be severe. Careful cleaning and disinfection are recommended
to prevent cross infection if used by multiple users.
●The conductive parts of the device must not be allowed to contact any conductive
parts, including protective earth connection.
●Keep the device and any part of the system away from the reach of children, pets
or pests when not in use.
●Portable RF communications equipment (including peripherals such as antenna
cables and external antennas) should be used no closer than 30 cm (12 inches) to
any part of the system. Otherwise, degradation of the performance of this system
could result.
●Use of this system adjacent to or stacked with other equipment should be avoided
because it could result in improper operation. If such use is necessary, this system
and the other equipment should be observed to verify that they are operating
normally.
●If the storage temperature is below 0°C , allow the parts of the system internal
temperature to stabilize for at least 30 min before use. Be aware of condensation
●If the part of the system is to be used in an environment prone to dirt build-up,
clean the device regularly. For cleaning, please follow the instructions provided in
paragraph “ Cleaning”.
●Use the system at least 30 cm (12”) away from the sources of power line frequency
magnetic fields, radio frequency communications equipment and other sources of
radio frequency signals (such as radars or microwave ovens).
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K- MYO User Manual
●If the measurement results are fluctuated by a strong nearby radio frequency
disturbance source, move further away from the source of the radio frequency
disturbances.
●Avoid using the system in the proximity of electrostatic disturbance sources. Do not
use close to a 2.4GHz signal source, as strong signals may negatively affect the
performance of the radio link.
●Prior to each use of the device you may want to re-check and confirm that parts are
properly attached.
●Should any problem occur as a result of the device, you are advised to discontinue
use immediately and contact your doctor or physician immediately
●Contact the manufacturer in case assistance is needed in setting up, using or
maintaining the device or to report unexpected operation or events.
●The K-Myo should only be used by trained professionals.
●The K-Myo is a medical sensor. The sensors should be treated with care. Do not
drop, bang, hit or subject the sensors to strong shock . Be careful to have a firm grip
when holding sensors in order to avoid accidental fall of the system which may
cause damage to the sensor or injury to the patient/operator.
●Not recommended for use in extreme temperatures, high humidity, or direct
sunlight
●Ensure your patient is able to keep his balance while watching the screen to avoid
fall
●Sensors are not known to contain any hazardous materials. For proper disposal
instructions, consult your local waste management facility. E-waste recycling
should be used where available.
●Do not service the battery while in use with a patient.
●Never disassemble or modify the system using any accessories not specifically
approved by KINVENT Biomécanique, LLC, this will void the warranty as well as
reduce immunity to electromagnetic interference, or increase electromagnetic
emissions, and result in improper operation.
●Don't place any K-Myo components on unstable surfaces, or surfaces subject to
vibration.
●Medical Electrical Equipment needs special precautions regarding EMC. K-Myo
needs to be installed and put into service according to the information provided in
this manual.
Replaceable Parts
●Holder
●Straps
●Accessories
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K- MYO User Manual
General Operating Conditions
Operating Environment
K-Myo must be used indoors. K-Myo must be used only in clean, dry rooms with leveled
floors. Make sure you have plenty of space around you when you use it.
Storage, Packaging and Transportation
Temperature:
-10 ºC to 40 ºC
(14 ºF to 104 ºF)
Pressure :
70kPa to 106kPa
Air Humidity:
30 % to 75 %
When not in use, please store it in the protective carrying pouch.
If the K Myo is stored for longer than 30 days, check battery level and recharge if necessary
before using.
Please observe the storage conditions and never store them in an automobile except
when transporting them.
Calibration
K-Myo gives you measurements of muscle activity. K-Myo is already calibrated, to make it
ready for use out of the box.
We recommend that the product be tested for calibration at least once a year under
normal use or sooner under severe conditions and usage. K-Myo are not user serviceable
and do not include a service manual. For more information on calibration as well as
special requirements, please contact your K-Myo dealer.
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K- MYO User Manual
Cleaning
The cleaning paragraph must be read thoroughly and understood before starting the
cleaning work.
K-Myo should be cleaned after each use. Cleaning and disinfection of the K-Myo can be
performed by the system operator or the patient/user.
In order to clean the K-Myo’s housing, use a damp cloth moistened with water or a mild
detergent. If the dirt is persistent, rub the surface of the K-Myo with a cloth moistened
with ethanol-based disinfectant or with 70% alcohol solvent. Do not use aggressive
cleaning agents such as acetone.
For more persistent stains and for disinfecting the K-Myo Low level or intermediate level
disinfectants should be used (e.g. alcohol wipes). Do not use bleach to clean the
plastic parts, prefer alcohol blends
Do not use objects that could damage or scratch the surface.
If the inside of the K-Myo is contaminated, contact your local distributor or KINVENT
support directly.
Careful cleaning and disinfection by the operator are recommended between uses to
prevent cross infection if worn by multiple users or patients. Disinfect before and after
each use. Allow disinfectants to dry before taking into use. Not to be worn by multiple
users if consequences of cross contamination may be severe.
Repetitive disinfection with ethanol-based disinfectant may in the long run cause aging
and discoloration of the case used. Discoloration does not affect safe use. If any cracks or
structural damage is observed, replace the device .
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K- MYO User Manual
Interface
1- Multi color LED
2- USB-C charge port
3- Power on/ Command orange button
4- 3.5mm jack for connecting to external leads to Channel 2
5- Snap in connector for electrodes of Channel 1
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K- MYO User Manual
LED States
●When the sensor is connected via USB, the sensor will turn on (GREEN flashing
LED) and begin to charge the internal battery.
●After 10 min, if not connected to the application, it will automatically power off . The
battery will continue to charge indicated by a pulsing ORANGE light.
●Once the battery reaches full charge the sensor will indicate this by switching to
permanent WHITE light. If power is removed the sensor will power on again.
●The sensor can wake by plugging in the USB cable or pushing the orange
button.The GREEN led starts blinking.
●When a successful connection over Bluetooth is attained then the light begins
flashing BLUE
●If the battery is low, then a RED light will flash intermittently three times and every
5 seconds. Wireless range may be affected if operating under this condition.
●The sensor will switch off if the battery voltage is lower than 1%.
●A single push on the button will display the battery status via bright red,yellow, or
green light depending on charge level.
Visual
LED Functionality
Explanation
Action requested
LED is OFF
Sensor is OFF
Press the button to
power on the sensor
GREEN LED is Blinking
Sensor is ON
Normal operation -
Sensor is ready to
connect
BLUE LED is Blinking
Sensor Connected
Sensor is connected
to the app
(tablet/phone)
ORANGE LED Slow blink
Sensor is OFF and
charging
None- the sensor will
continue charge until
full
WHITE LED is lit steady
Sensor has reached
End of charge
Internal battery is
100%, please remove
charging cable
RED LED is blinking
(three blinks
intermittently)
Sensor has low
battery (<10%)
Please charge the
sensor
Action
LED behavior
Explanation
Button pressed
once during ready
or connected state
Steady lit LED color
Green, Yellow or Red
Battery state of charge
Green : 71 to 100%
Yellow : 31 to 70%
Red : <30%
Button pressed
once during a
“Start screen” in
the app
Steady lit LED color
Green, Yellow or Red
Will also start the training/exercise selected
or switch sides depending on the app
message
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K- MYO User Manual
K-Myo
Description
K-Myo is used for the evaluation of the
activation of a muscle during training. K-Myo
qualitative measures the muscle effort caused
during training
Benefits
K-Myo is an electromyography tool that
measures the biopotential and gives you
real-time biofeedback on your tablet or
smartphone through the Kinvent Physio app.
Therefore, you can set strength objectives for
your patient and motivate him through the
process of rehabilitation. You will, then,
follow-up your patient's progress through the Kinvent Physio interactive database.
Usability Data
Intended medical indication:
For the evaluation of different muscle activation levels
Intended patient population
Teenagers to geriatric, with normal health or pre/post operation only on doctor’s approval
for rehabilitation.
Intended part of the body or type of tissue to or interacted with:
Site: External areas , typically arms, hands, torso, head, legs, feet
Condition: Normal, no abscesses nor wounds.
Direct contact via metallic pads (silver) or gel type pads
Intended User Profile:
The K-Myo must be used by a trained health professional. The user must have received
sufficient training in clinical procedures to get reliable measurements.
Intended use environment :
Hospital or other medical practice environment.
Operating Principle:
K-Myo is equipped with an electronic converter that measures the muscle activation
signals in the mV range and amplifies them for them to be measured.
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K- MYO User Manual
Technical Features
Dimensions and Weight
Weight
37 g / 1.30 oz with holder
30 g / 1.05 oz device only
Dimensions (H x W x L)
Metric : 60 x 40 x 16.5mm
With holder 64 x 57 x 16.5 mm
Channels
2 (1 internal, 1 external via 3.5mm
jack)
External channel contains a bias
channel
Gain
Software selectable 6,8,12,24
Acquisition frequency
1000Hz
Eco features
Self-activated “sleep” mode after 10
minutes.
Electrical and Communication Data
Radio Technology
Bluetooth Low Energy 5.1
Power supply
1 cell 3.7V Li-Po Battery 200mAh
Radiated output power
Max.10 mW
Wireless transmission
Frequency
2.4 GHz band
2402- 2480 MHz
Modulation
GFSK
Channel Bandwidth
2 MHz
ERP
8.6dbm
Wireless range
Up to 40 meters / 44 yd
Contains FCC ID
2AAQS-ISP1807
Input Differential range
750mV (at 6 Gain) , 187mV (24 Gain)
Input Protection
ESD 12kV, Current limiting
ADC, sampling and
bandwidth
24 bit ADC, up to 2000 Hz ,
Bandwidth 10-1061 Hz Channel 1
Bandwidth 0-1061 Hz Channel 2 (use
of external Bias lead)
Battery
12h of autonomy, 2h for charging
Minimum requirements
Android 6.0+ or iOS 11.0+, Bluetooth
Low Energy
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K- MYO User Manual
Get Started
On the top surface of the sensor there are : one USB-C port used for charging, one LED
indicator for the working state/charging state and one push-button.
You can charge your K-Myo sensor through the USB A to USB C cable provided or with
any USB-C charging cable. The sensor is supplied with the appropriate IEC 60601 medical
USB power supply. If a different charger is used, ensure that it meets the minimum
medical safety requirements and if unsure please do not use the sensor while plugged
in/charging.
Disinfect K-Myo prior to use. Low level or intermediate level disinfectants should be
used (e.g. alcohol wipes). Do not use bleach to clean the plastic parts, prefer alcohol
blends
Press the orange power on button on K-Myo. The indicator begins flashing green. Your
sensor is ON! Your sensor will turn off after 10 minutes of no Bluetooth connection or no
application connection.
Once the sensor is turned on, select the K-Myo sensor activity in the Home Page. At this
step, the K-Myo is connected and the LED starts flashing Blue.
While your K-Myo is connecting, don’t touch the EMG leads.
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K- MYO User Manual
Accessories
The K-Myo is provided with the following accessories
●Strap and holder
●Single use patches with snap connector
Ø 35 mm
Kendall EKG adhesive electrode H135SG -
diameter of the electrode 24 mm
50 electrodes per bag
Ag / AgCl sensor - embedded in an adhesive
and conductive liquid hydrogel
The carrier material is foam (adhesive) -
suitable for sweaty patients
Good long-term adhesive strength -
experience has shown that it is very suitable
for use in the sleep laboratory for EKG, EOG
and EMG.
REF: 31.1355.21
●Multi-use AgCL snap pads
●Reusable triple strap with leads and a 3.5mm
jack for use with the secondary channel
(CH2)
○Left, Right, and Bias channels
●EMG leads with 3 snap-on connectors and a
3.5mm jack for use with the secondary
channel (CH2)
○Silicone rubber
○Shielded
○3.5mm phone jack connector
○Length: 80 cm or 60 cm
○Left, Right, and Bias channels
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