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.
10 © 2023 KINVENT Biomecanique KM2023C_EN