Otto Bock 757M20 Series User manual

Instructions for use (qualified personnel) ........................................................................... 3
757M20=*

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.
2

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 "757M20=* Myo cuff" is referred to as the product/cuff below.
These instructions for use provide you with important information on the use, adaptation and
handling of the product.
The product may not be transferred to the patient without prior instruction.
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 intended to determine the suitability of a patient for using Myo Plus control. The
product is a flexible armband that is temporarily applied to the patient's forearm. This makes it
possible to evaluate the patient's signal patterns using the Myo Plus app, without fabricating a
check socket. In case of problems with separation of the signal patterns, the patient can use the
product to practise at the facilities of the O&P professional or in the rehabilitation centre.
The product is a flexible armband that is applied to the end user's sound limbs.
The product measures the patient's control signals and assigns them to the prosthesis move
ments.
2.2 Design
The product consists of the following components:
11. Remote electrode dome
2. Textile cuff snap fasteners
3. Charging receptacle and battery
4. Textile cuff
5. Housing for remote electrodes and battery
6. Housing and MyoPlus TR
7. Nameplate
3

4
Explanation of symbols
21. Donning direction (left/right)
The arrow has to point towards the hand.
2. Charging receptacle
3. Alignment for the patient's ulna
4. Electrode position (1–8)
3 Intended use
3.1 Indications for use
The product is to be used exclusively for exoprosthetic fittings of the upper limbs.
3.2 Conditions of use
The product is to be used exclusively for the period of end user evaluation and training.
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.
3.5 Qualification
Fitting a patient with the product may only be carried out by O&P professionals, therapists or
nursing staff who have been authorised by Ottobock upon completion of a corresponding training
course. Furthermore, the O&P professional must have the technical qualifications required for the
alignment of a prosthesis together with all necessary settings and adjustments.
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.

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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.
4.3 General safety instructions
WARNING
Non-observance of safety notices
Injury due to faulty control or malfunction of the product.
Destruction of the product.
►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.

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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
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" (Cleaning and
care).
CAUTION
Reuse on another user without corresponding cleaning of the product
Skin irritation due to soiling of the product by a previous user.
►Only use the product on one user for the duration of a fitting.
►Between two fittings, send the product to the Ottobock Service Centre for cleaning.
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
Use of a damaged product
Injury due to material damage of the product.
►Inspect the product each time for sharp-edged and pointy parts before putting it on.
►Have the product repaired by an authorised Ottobock Service Centre in case of damage.

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NOTICE
Insufficient skin contact of the electrodes
Insufficient information about the suitability of the muscle signals to use MyoPlus
►Makes sure that the contact surfaces of the electrode domes are placed on intact skin only
and have full-surface contact during a test.
NOTICE
Shifting of the electrodes
Insufficient information about the suitability of the muscle signals to use MyoPlus
►Make sure that the electrodes do not shift during a test, or restart the test.
NOTICE
Incorrect electrode settings due to muscle fatigue
Insufficient information about the suitability of the muscle signals to use MyoPlus
►Make sure that breaks are taken during calibration.
NOTICE
Penetration of dirt and humidity into the product
Reduction of the informative value of the muscle signal due to product malfunction.
Skin irritation due to dirt or chemical reactions in combination with perspiration.
►Make sure that neither solid particles nor liquids can penetrate into the product.
NOTICE
Improper product disposal
Environmental damage due to improper disposal.
►After the end of the service life or in case of total loss of the product, dispose of the product
according to the applicable national legal regulations.
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. 646C107 Bluetooth PIN card
• 1 pc. 757M20=* Myo gaiter
includes: 13Z161 electrode dome, flat ▀ or 13Z162 electrode dome, medium ▀ or 13Z163
electrode dome, high ▀
• 1pc. battery charger 757L35 MyoCharge Integral
• 1pc. Instructions for use (qualified personnel)
Accessories
• Myo Plus app
• 1pc. 757P41-1 Y-cable
6 Charging the battery
We recommend charging on a daily basis. If the device is not used for an extended period, the
battery charge level should be checked regularly and the battery recharged.
1) Connect the charging plug to the charging receptacle of the product.
→A correct connection between the battery charger and the product is indicated by feed
back (see page14).

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→The product is switched off automatically.
→The charging process starts.
2) Disconnect the battery charger from the product after the charging process is complete.
7 Preparing the product for use
7.1 Determine electrode position
1) Pull the product over the end user's forearm.
2) Position the product 6 to 7cm distal of the olecranon.
3) Position the charging pill laterally.
INFORMATION
Make sure that the electrode domes are in contact with the end user's skin.
7.2 Establishing a connection to a demo prosthesis
Prerequisite for intended use
• Base
• 10S17 Active rotation unit
• Compatible hand prosthesis
• Compatible battery
Note the following steps for establishing a connection:
1) Open the product's fabric far enough so the cables (two-pin cable and 757P41-1 Y-cable)
can be brought to the outside.
2) Refasten the product's snap fasteners.
3) Connect the projecting cables to the sup
plied extension cables.
Make sure the cables are respectively con
nected with the same marking.
2
3
4
5
7
8
6
4) Connect the other ends of the extension
cable to the demo prosthesis.
See the information for connecting the
rotation unit in the Myo Plus TR instruc
tions for use.
5) Switch on the product and connect to the
app.
6) In the menu of the Myo cuff, press the
“Connect demo prosthesis” button.
7) Switch the prosthesis on within ten
seconds.
INFORMATION
Only use the 757P41-1 Y-cable for the connection.

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8 Myo Plus app
With the Myo Plus app, the user can view and evaluate their signals and the fre
quently used functions together with the O&P professional. The repeatability of
movements can be trained with the app. When combined with the product, the
app permits the simulation of bebionic hands or MyoBock hands.
INFORMATION
The Myo Plus app can be downloaded free of charge from the respective online store. To down
load the Myo Plus app, the QR code on the supplied Bluetooth PIN card can be read with the
mobile device (requirement: QR code reader and camera).
8.1 System Requirements
See the information in the Apple App Store or Google Play Store regarding compatibility with
mobile devices and versions.
8.2 Initial connection between MyoPlus app and product
The following points should be observed before the initial connection:
• Bluetooth on the mobile device must be switched on.
• The Bluetooth ID and Bluetooth PIN of the product being connected must be known.
The Bluetooth PIN and Bluetooth ID are found on the enclosed Bluetooth PIN card.
The Bluetooth ID is found on the Myo Plus TR (see fig.1, item 6) and starts with the letters
"BT ID".
8.3 Starting the Myo Plus app for the first time
INFORMATION
Keep mobile app up to date.
• Please contact the manufacturer if you suspect cybersecurity problems.
INFORMATION
Bluetooth on the prosthesis must be turned on in order to use the MyoPlus app.
After turning on Bluetooth, it remains active for approx. 5 minutes. The app must be started and
the connection established during this time.
1) Tap the icon for the Myo Plus app .
→The end user licence agreement (EULA) is displayed.
2) If rights are requested the first time the app is started, these have to be granted. Otherwise,
the app cannot be started.
3) Accept the end user licence agreement (EULA). If the end user license agreement (EULA) is
not accepted, the Myo Plus app cannot be used.
4) The "Bluetooth connection" menu item is opened.
5) Tap to establish a connection.
6) Select the desired component from the list.
7) Enter the Bluetooth PIN code and tap "Connect".
→The icon is displayed when the connection has been established.
→Once the connection has been established, the data are read from the component. Then the
radar chart is displayed.

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9 Use
9.1 Evaluating muscle signals in the MyoPlus app
3To perform an evaluation of the muscle signals or for training, the
following steps have to be completed:
1) Press the charging receptacle button and hold for one second.
→The product is switched on.
→Two short beeps are emitted.
2) In the app, tap the "Myo Cuff" menu.
3) Select the desired hand that was chosen in the planned fitting.
→Now the muscle signals can be evaluated and trained.
Connecting to the demo prosthesis
1) Press the Myo cuff button and hold for one second.
→The product is switched on.
→Two short beeps are emitted.
2) Establish a connection between Myo Plus and the Myo cuff.
3) In the app, tap the “Myo cuff” menu.
4) Press the button to establish a connection to the demo prosthesis.
5) Switch on the demo prosthesis within 10seconds.
→Now the muscle signals can be evaluated and trained.
9.2 Display of the current charge level
The battery charge level can be queried at any time.
1) With the product switched on, press the button on the charging receptacle and hold for less
than one second.
2) The LED display on the charging receptacle provides information on the current battery
charge level (see page14).
9.3 Safety Shutoff
The purpose of the safety shutoff is to protect the battery; it is triggered in case of:
• Excessively high or low temperature during the charging process
• Short circuit
• Overvoltage or undervoltage
INFORMATION
After a safety shutdown, the battery charger must be connected to reactivate the electronics.
10 Cleaning and Care
CAUTION
Reuse on another user without corresponding cleaning of the product
Skin irritation due to soiling of the product by a previous user.
►Only use the product on one user for the duration of a fitting.
►Between two fittings, send the product to the Ottobock Service Centre for cleaning.