Otto Bock Myo Plus User manual

Instructions for use (qualified personnel) ........................................................................... 5
Myo Plus

Caution: Federal law (USA) restricts this device to sale by or on the order of a practitioner
licensed by law of the State in which he/she practices to use or order the use of the device.
Quick Reference GuideThis "Quick Reference Guide" does not replace the instructions for use
Angewandte Symbole / Symbole Used / Symboles utilisés / Simboli utilizzati / Símbolos utilizados /
Símbolos utilizados / Gebruikte symbolen / Symboler som används / Anvendte symboler / Benyttede sym
boler / Käytetyt symbolit / Stosowane symbole / Alkalmazott jelképek / Použité symboly / Rabljeni simboli /
Uporabljeni simboli / Použité symboly / Kullanılan semboller / Применяемые символы / 本取扱説明書で使用
している記号 / 使用的图标
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Wrong
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use drilling machine
use tape
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13E190
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1 Foreword English
INFORMATION
Date of last update: 2022-03-29
►Please read this document carefully before using the product and observe the safety
notices.
►Instruct the user in the safe use of the product.
►Please contact the manufacturer if you have questions about the product or in case of prob
lems.
►Report each serious incident related to the product to the manufacturer and to the relevant
authority in your country. This is particularly important when there is a decline in the health
state.
►Please keep this document for your records.
The product "Myo Plus" is referred to as the product below.
These instructions for use provide you with important information on the use, adaptation and
handling of the product.
Only put the product into use in accordance with the information contained in the accompanying
documents supplied.
According to the manufacturer (Otto Bock Healthcare Products GmbH), the patient is the operat
or of the product according to the IEC 60601-1:2005/A1:2012 standard.
2 Product description
2.1 Function
The product is used to control a myoelectric prosthesis.
The product measures the patient's control signals and assigns them to the prosthesis move
ments.
By calibration via the Myo Plus app, the control unit learns to assign the sampled muscle signals
to the various movement types. This calibration can be carried out directly by the user and
repeated at regular intervals.
Essential performance of the product
• No essential performance according to IEC 60601-1
2.2 Design
The product consists of the following components:
Remote electrodes
11. Electronics housing
2. Dome nut and cable lug
3. Electrode dome
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Myo Plus TR
2The Myo Plus TR (1) receives the signals from
the remote electrodes and converts them into
control signals for the prosthesis components
(hand, rotation). Up to 8 remote electrodes can
be connected to the Myo Plus TR.
To secure the remote electrode plug connec
tions, slide the cable protection cap (2) onto
the Myo Plus TR.
2.3 Combination possibilities
This product can be combined with the following Ottobock components:
Terminal devices
INFORMATION
The 13E190=* switch block has to be used for combination with the 8E34=*, 8E39=*, 8E41=*
and 8E71=* terminal devices.
• System Electric Hand DMC plus: 8E38=6,
8E39=6
• Sensor Hand Speed: 8E38=8, 8E39=8
• MyoHand VariPlus Speed: 8E38=9,
8E39=9, 8E41=9
• Transcarpal Hand DMC plus: 8E44=6
• System Electric Greifer DMC VariPlus:
8E33=9, 8E34=9
• DMC VariPlus System Electric Greifer:
8E33=9-1, 8E34=9-1
• bebionic hand EQD: 8E70=*
• bebionic hand Short Wrist: 8E71=*
• bebionic hand Flex: 8E72=*
INFORMATION
Connected terminal devices must be in a proportional 2-channel mode.
Active rotation
• 10S17 electric wrist rotator
• 10S1=* lamination ring
Passive rotation
• 9E169 coaxial plug
• 10S4 coupling piece
• 10S1=* lamination ring
Rechargeable battery
• 757B35=5 MyoEnergy Integral
• 757B35=3 MyoEnergy Integral
• 757B20 EnergyPack
• 757B21 EnergyPack
3 Intended use
3.1 Indications for use
Myo Plus is to be used exclusively for exoprosthetic fittings of the upper limbs.

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3.2 Conditions of use
The product was developed for everyday use and must not be used for unusual activities such as
extreme sports (free climbing, paragliding, etc.). Furthermore, the product must not be used for
the operation of motor vehicles, heavy equipment (e.g. construction machines), industrial
machines, firearms or motor-driven equipment.
The product is intended exclusively for use on one patient. Use of the product by another person
is not approved by the manufacturer.
3.3 Indications
• For patients with unilateral and bilateral amputations.
• For patients with transcarpal and transradial amputation.
3.4 Contraindications
• For patients with transhumeral amputation.
• For patients with partial hand amputation.
• For patients with shoulder disarticulation.
• For patients who are not able to generate an adequately separable pattern.
3.5 Qualification
Fitting a patient with the product may only be carried out by O&P professionals who have been
authorised by Ottobock after completion of a corresponding training course. The O&P profes
sional also has to have the technical qualifications required for the alignment of a prosthesis with
all required settings and adjustments.
The user must be instructed about the use of the product by authorised, qualified personnel.
The "O&P professional mode" of the adjustment app may only be used by qualified personnel,
therapists and nursing staff after participating in the relevant product training and obtaining certi
fication for the application. Additional product training courses may become necessary to qualify
for app updates.
4 Safety
4.1 Explanation of warning symbols
WARNING Warning regarding possible serious risks of accident or injury.
CAUTION Warning regarding possible risks of accident or injury.
NOTICE Warning regarding possible technical damage.
4.2 Structure of the safety instructions
WARNING
The heading describes the source and/or the type of hazard
The introduction describes the consequences in case of failure to observe the safety instruc
tions. Consequences are presented as follows if more than one consequence is possible:
> E.g.: Consequence 1 in the event of failure to observe the hazard
> E.g.: Consequence 2 in the event of failure to observe the hazard
►This symbol identifies activities/actions that must be observed/carried out in order to avert
the hazard.

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4.3 General safety instructions
WARNING
Non-observance of safety notices
Personal injury/damage to the product due to using the product in certain situations.
►Observe the safety notices and the stated precautions in this accompanying document.
WARNING
Operating the product near medical devices critical for safety
Interference with life-sustaining medical devices (e.g., pacemaker, defibrillator, heart-lung
machine, etc.) due to electromagnetic interference of the product.
►When operating the product in the immediate vicinity of life-sustaining medical devices,
ensure that the minimum distances stipulated by the manufacturer are observed.
►Make sure to observe the operating conditions stipulated by the manufacturer and the safety
notices.
WARNING
Use of inappropriate components
Injury due to malfunction of the product.
►Operate the product only with components prescribed by the manufacturer. You can find the
list of components in the section "Combination possibilities".
►Operate the product only with accessories recommended by the manufacturer. You can find
the list of components in the section "Scope of delivery and accessories".
WARNING
Changes or modifications to the product made independently
Injury due to faulty operation or malfunction of the product.
►Have any changes or modifications to the product carried out only by authorised, qualified
Ottobock personnel.
►The battery may only be handled by authorised, qualified Ottobock personnel (replacement
by the user is not permitted).
►The product and any damaged components may only be opened and repaired by authorised,
qualified Ottobock personnel.
CAUTION
Penetration of dirt and humidity into the product
Injury due to faulty control or malfunction of the product.
►Ensure that neither solid particles nor liquids can penetrate into the product.
►Make sure that the plug connections are sealed with silicone grease.
CAUTION
Mechanical loads
Injury due to faulty control or malfunction of the product.
►Do not subject the product to mechanical vibrations or impacts.
►Check the product and its housing for visible damage (e.g. cracking or breakage). If the
product is damaged or does not function properly, contact your Ottobock Service Centre.
►Watch for loosened electrode domes.
►Secure the remote electrodes and cables on the inner socket using suitable material (such
as adhesive tape) to reduce cable movement.

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CAUTION
Proximity to sources of strong magnetic or electrical interference (e.g. theft prevention
systems, metal detectors)
Injury due to unexpected behaviour of the product caused by interference with internal data
communication.
►Avoid remaining in the vicinity of visible or concealed theft prevention systems at the
entrance/exit of stores, metal detectors/body scanners for persons (e.g. in airports) or other
sources of strong magnetic and electrical interference (e.g. high-voltage lines, transmitters,
transformer stations, computer tomographs, magnetic resonance tomographs, etc.).
►When walking through theft prevention systems, body scanners or metal detectors, watch
for unexpected behaviour of the product.
CAUTION
Electrode lifting off
Injury due to unexpected product behaviour as a result of uncontrolled activation of the pros
thesis component.
►Inform the patient that uncontrolled movement of the prosthesis component may occur if the
electrode lifts off.
CAUTION
Skin irritation due to inadequate cleaning of the product
Skin irritation due to contact with soiled electrode domes.
►Clean the product only as described in the section "Cleaning and care" (see page17).
CAUTION
Insufficient skin contact of the electrodes
Injury due to faulty control or malfunction of the product.
►The electrodes are to be placed on intact skin only and with as much electrode-skin contact
as possible.
►Use the different electrode dome heights to improve the skin contact.
►Make sure that skin contact of the electrodes continues to be given when carrying heavy
loads.
CAUTION
Insufficient space for electrode domes because distance is too small
Injury due to unexpected prosthesis behaviour.
►Make sure that the electrode domes do not touch each other. Reduce the number of elec
trode domes if necessary (e.g. if the arm is very thin).
►Watch the electrode contacts if the residual limb swings or moves.
►Use suitable dome heights according to the fit of the prosthetic socket.
CAUTION
Incorrect electrode settings due to muscle fatigue
Injury due to faulty control or malfunction of the product.
►The patient should take breaks during calibration.

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CAUTION
Insufficient distance to HF communication devices (e.g. mobile phones, Bluetooth
devices, WiFi devices)
Injury due to unexpected behaviour of the product caused by interference with internal data
communication.
►Therefore, keeping a minimum distance of 30cm from HF communication devices is recom
mended.
CAUTION
Operating the product in very close proximity to other electronic devices
Injury due to unexpected behaviour of the product caused by interference with internal data
communication.
►Do not operate the product in the immediate vicinity of other electronic devices.
►Do not stack the product with other electronic devices during operation.
►If simultaneous operation cannot be avoided, monitor the product and verify proper use in
the existing setup.
CAUTION
Improper securing of the electrode domes
Injury due to product malfunction.
►Do not use thread locking compound (Loctite) to secure the electrode domes. Applying
thread locking compound forms an insulating layer that prevents transmission of the EMG
signals.
NOTICE
Failure to observe the system requirements for the installation of the Myo Plus app
Malfunction of the device.
►Install the Myo Plus app only on the operating systems listed in the section "System require
ments" (see page14). The tested devices are listed in this section as well.
NOTICE
Mechanical damage to the product
Change in or loss of functionality due to damage.
►Use caution when working with the product.
►If the product is damaged, check it for proper function and readiness for use.
►Take any necessary measures (e.g. repair, replacement, inspection by the manufacturer's
customer service, etc.).
5 Scope of Delivery and Accessories
Scope of Delivery
Items in the scope of delivery or accessories marked with ▀ are application parts according to the
IEC 60601-1:2005/A1:2012 standard.
• 1 pc. 13E520 Myo Plus TR
• 1pc. 646C107 Bluetooth PIN card
• 1 pc. lug wrench
• 1 pc. lamination dummy for Myo Plus TR
• 1 pc. positioning gauge for O&P professional 623F50
• 3 pc. 13Z164 cable marking