myon m320 User manual

Transmitter, Receiver, Charging Cradle
Model: myon m320
USER MANUAL

History of changes
Version Author Date Comments
1.0 myon AG 06.10.2011 Initial release.
1.1 myon AG 18.01.2012 Minor changes.
1.2 myon AG 21.03.2012 Minor addendum.
1.3 myon AG 07.05.2012 Minor addendum and changes.
1.4 myon AG 14.06.2012 Enhanced usage guidance.
1.5 myon AG 23.08.2012 Minor addendum and some smaller changes.
1.6 myon AG 03.01.2013 Address changes and minor corrections.
1.7 myon AG 28.04.2014 Added device verification procedures; added mains plug instructions;
updated FCC information; technical data addendums; corrections.
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Copyright
Copyright © 2009-2014 myon AG. All rights reserved. This publication may not, without the prior
written permission of myon AG, be reproduced in any form or by electronic, mechanical, magnetic,
optical, chemical, manual or other means, transmitted, transcribed, stored in a retrieval system or
translated into any language or computer language.
Disclaimer
myon AG does neither directly nor indirectly guarantee the accuracy of this manual and specifically
disclaims any warranties as to the quality or fitness for a particular purpose. Furthermore, myon AG
reserves the right to revise this publication without notice and to make changes to the content.
Technical changes reserved. As a result of further technical development, illustrations and technical
data may differ.
myon AG makes no warranties, express or implied, as to the quality and performance of this product
including but not limited to, any implied warranty of applicability for other than research uses by
qualified individuals. myon AG shall not be liable to any person for any medical expenses or any
direct or consequential damages resulting from any defect, failure or malfunction, whether a claim
for such damage is based upon theory of warranty, contract, tort or otherwise. No representative,
agent, or licensed practitioner is authorized to waive this disclaimer. myon AG makes no diagnosis or
prescription by virtue of anything about this product.
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Table of Contents
1 Important information............................................................................................................................................6
1.1 Introduction...................................................................................................................................................................6
1.2 Conventions used in this text........................................................................................................................................6
1.3 Important information..................................................................................................................................................6
1.4 Power supply safety.......................................................................................................................................................7
1.5 Cleaning and care...........................................................................................................................................................7
1.6 Maintenance..................................................................................................................................................................7
2 Preface....................................................................................................................................................................8
2.1 Intended use..................................................................................................................................................................8
2.1.1 Transmitters.....................................................................................................................................................................8
2.1.2 Receivers..........................................................................................................................................................................8
2.1.3 Charging Cradles..............................................................................................................................................................8
2.2 Contraindications..........................................................................................................................................................8
2.3 Possible combinations..................................................................................................................................................9
3 System overview...................................................................................................................................................10
3.1 Power supplies.............................................................................................................................................................10
3.1.1 Power supply leads with and without ferrite................................................................................................................11
3.1.2 Country specific mains plug...........................................................................................................................................11
3.2 Transmitter..................................................................................................................................................................12
3.2.1 Reset switch...................................................................................................................................................................12
3.3 Receiver.......................................................................................................................................................................13
3.4 Charging cradle............................................................................................................................................................13
4 LED function indicators.........................................................................................................................................14
4.1 Transmitter..................................................................................................................................................................14
4.2 Receiver.......................................................................................................................................................................14
4.3 Charging cradle............................................................................................................................................................14
5 Operation..............................................................................................................................................................16
5.1 Parts included in shipment..........................................................................................................................................16
5.2 Unpacking and transport.............................................................................................................................................16
5.3 Device installation.......................................................................................................................................................17
5.4 Charging of transmitters.............................................................................................................................................18
5.5 Conduction of measurements.....................................................................................................................................19
5.5.1 Establishing a wireless connection..............................................................................................................................19
5.5.2 Capturing and transmission of sensor signals...........................................................................................................19
5.5.3 Transmitters with EMG sensor cable..........................................................................................................................20
5.6 Recommendations for optimal signal transmission and radio coverage....................................................................20
5.6.1 Receiver..........................................................................................................................................................................21
5.6.2 Transmitter....................................................................................................................................................................21
6 Turning off the device...........................................................................................................................................22
6.1 Transmitters................................................................................................................................................................22
6.2 Receiver.......................................................................................................................................................................22
6.3 Charging cradle............................................................................................................................................................22
7 Checks...................................................................................................................................................................23
7.1 Verification procedure for the correct functioning of the equipment...........................................................................23
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7.1.1 Visual check of basic functions......................................................................................................................................23
7.1.2 Check of installation and wiring....................................................................................................................................24
7.1.3 Check of transmitter's sensor cable integrity..............................................................................................................25
8 Solving problems..................................................................................................................................................26
9 Technical description.............................................................................................................................................27
9.1 Technical data..............................................................................................................................................................27
9.2 Description of interfaces.............................................................................................................................................28
9.2.1 Models with analog EMG output for up to 16 channels.............................................................................................28
9.2.2 Models with analog EMG output for more than 16 channels....................................................................................29
9.2.3 Pin assignment of DSub25 connector........................................................................................................................29
9.3 Technical support........................................................................................................................................................30
9.3.1 How your EMG signals should look like.......................................................................................................................30
9.3.2 Visualization of transmission errors...........................................................................................................................30
10 Regulatory Information.......................................................................................................................................32
10.1 Name and address of the manufacturer....................................................................................................................32
10.2 Identification of the devices covered.........................................................................................................................32
10.2.1 Trade or proprietary names.........................................................................................................................................32
10.3 International Electrotechnical Commission (IEC)......................................................................................................32
10.4 For customers within the European Economic Area..................................................................................................32
10.4.1 Restriction of the Use of certain Hazardous Substances in Electrical and Electronic Equipment (RoHS)...........32
10.4.2 Registration, Evaluation, Authorisation and restriction of CHemicals (REACH)...................................................33
10.4.3 Waste Electrical and Electronic Equipment (WEEE)................................................................................................33
10.4.4 Declaration of Conformity..........................................................................................................................................34
10.4.5 Medical Device Adverse Event Reporting.................................................................................................................34
10.5 For customers within the United States of America.................................................................................................35
10.5.1 Federal Communications Commission (FCC).............................................................................................................35
10.5.2 Statement of Declaration of Conformity..................................................................................................................36
10.6 For customers within all other countries...................................................................................................................36
11 Safety and usage guidance...................................................................................................................................37
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1 Important information
1.1 Introduction
In this manual you will find important information, needed for the commissioning and operation of
the device.
Always adhere to the safety instructions in the manual of your computer or other systems involved
and the ones in this handbook! If you experience any problems, please contact your local sales
agency or the respective manufacturer.
1.2 Conventions used in this text
Throughout this manual the following conventions are used.
Indicates important information that may damage your health, the functioning of the
device or the safety of your data if not adhered to.
Indicates additional information and tips.
1.3 Important information
Please follow these safety instructions
to ensure your safety and the optimal functioning of the device.
The product may be used only as intended (see Section 2.1) and in compliance with the instructions
in this user manual, by appropriately trained and qualified personnel. Assembly, modifications,
maintenance and repairs have to be carried out by the manufacturer or personnel authorized by the
manufacturer.
Repair attempts by the user are not permitted and will result in a loss of warranty as
well as in a loss of conformity with regulatory requirements voiding the user’s
authority to operate the device.
The product can only be used in combination with accessories, that are specified in the user manual
or by the manufacturer by other means. Other combinations, accessories and consumable parts may
only be used if they are specifically designed for the intended application and do not affect
performance, and safety requirements.
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The device contains Lithium-Polymer batteries. Do not damage, crush, burn, freeze or otherwise
mishandle the device. Recharge only with the power supply and charging cradle supplied with your
myon m320 system.
1.4 Power supply safety
•Disconnect the system from the mains when not in use. You can disconnect the receiver and
the charging cradle by pulling the power plug from the mains power outlet.
•The power cord in devices with mains plugs is used for separation from the mains. The
power outlet must be located in the vicinity of the device and must be easily accessible.
•The power supplies must be used with a suitable power outlet. If you are not sure if the
outlet is suitable, please contact the local power company.
•Make sure that your power supply is equipped with the correct country specific mains
adaptor and that the adapter is correctly and firmly installed.
•The device is not suitable for use outdoors.
•The device is not suitable for unattended continuous operation.
1.5 Cleaning and care
•Unplug the power cord from the outlet before cleaning a device.
•The devices can be cleaned with a slightly water and/or alcohol moistened, soft, lint-free
cloth. Do not use harsh cleaners, aerosol cleaners or glass cleaners.
•Objects or liquids must not get into the interior of the device.
•Check the device after each cleaning to its functions and to possible damage occurred. If you
notice any damage, do not make any repair attempts, but contact your sales agency or the
manufacturer.
To maintain functionality of the myon system all electrical contacts should always be
kept clean.
In particular, adhesive tape or similar substances must not be attached to the
charging contacts of the transmitter or the charging cradle slots' contacts.
Please note that myon offers special fastening straps (P/N PA0003 ... PA0009) for the
purpose of affixing the transmitter securely to the body.
1.6 Maintenance
No user serviceable parts inside. Do not open or remove the protective housing yourself as you might
expose yourself to dangerous voltages and other risks. In case of abuse or accident (such as dropping
the unit or improper use) please contact your local sales agency or the manufacturer for
maintenance. Store all devices in a secure and dry place when not in use.
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2 Preface
2.1 Intended use
The myon320 system is designed to capture and wirelessly transmit EMG sensor signals recorded
from human muscles. The myon320 can not be used for the electrical stimulation of muscles.
All product models and types of the product may only be used externally and non-invasively by
professional users (e.g. healthcare professionals, doctors, researchers, etc.). Only the components
(sensors, power supply, etc.) supplied by the manufacturer are to be used. Additional sensors or
spare parts are available upon request from the manufacturer.
2.1.1 Transmitters
The transmitters are intended to record a signal from a pair of electrodes. The recorded signal is
immediately digitized and transmitted to the receiver.
The electrode sensor cables are made from material allowing the implementation of
thin leads with a very high grade of flexibility to reduce cable and movement
artefacts.
However, please keep in mind, that the sensor cables have a limited capability of
dealing with mechanical stress. You therefore must avoid any tractive and/or shearing
forces and/or torsion to be applied onto the sensor cables.
2.1.2 Receivers
The receivers are intended to receive the sensor data from the transmitter and to output the
received data via an analogue output interface for further use with 3rd party hardware systems
and/or software.
2.1.3 Charging Cradles
The charging cradle is used to re-charge the transmitter batteries. It is also intended as a place in
which to safely store the transmitters when they are not in use.
2.2 Contraindications
Do not use the device on patients with implanted electronic devices of any kind (e.g. cardiac pace
makers). The device must not be used in critical care settings / applications or on irritated skin or
open wounds.
If the device is used on a patient also connected to high-frequency surgical equipment, such usage
may result in burns at the site of the EMG sensor.
The medical practitioner and/or user always has to decide on the basis of the general condition of
the patient or subject whether or not the intended application is reasonable. Further information is
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accessible in current scientific literature.
The device is not intended for use in an operating theatre, anesthetic gas or oxygen-rich
environments. Not for use where there is a risk of compromising the essential performance of
medical electrical equipment. Not suitable for use in high magnetic flux, ionizing radiation, sterile,
or life- or safety-critical environments. The device is not suitable for unattended continuous
operation.
2.3 Possible combinations
In addition to these instructions, the instructions of those products used in combination (e.g.
analog-to-digital converters, video motion capture systems, EMG electrodes) must also be observed.
Potential electromagnetic or other interference that occurs between the product and other products
may lead to disturbances or malfunctions.
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3 System overview
The systems is comprised of three main components: Transmitter, charging cradle and receiver.
Image 1: Transmitter Image 2: Charging cradle Image 3: Receiver
3.1 Power supplies
Receiver and charging cradle each require a different specific medical grade external power supply to
operate.
Image 4: Power supply
•Mains power supply
•Country specific mains
plug
•Device's power supply
plug with mechanical
reverse voltage protection
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