ottobock Myo Plus TR and Electrodes Instruction Manual

: June 4, 2024
: ottobock

Table of Contents

Foreword
Intended use
Safety
Support
References
Read User Manual Online (PDF format)
Download This Manual (PDF format)

ottobock Myo Plus TR and Electrodes Instruction Manual

Download the Instructions for use (qualified personnel)

oder / or
https://product-documents.ottobock.com/IFU/INT/13E520/647G1381/08/O/S/F

You can order a printed version of the Instructions for use (647G1381-0, version 08) at no charge in the respective national language at the address below.

Foreword

INFORMATION

Date of last update: 2022-04-01

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 problems.
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.

Note the instructions for use
This document contains the sections “Intended use” and “Safety”, and does not replace the instructions for use. The instructions for use are available in digital form (PDF format) (see page 2 of this document). To view PDF files, you need an Internet browser or other program capable of opening this file format. You may request a printed copy of the instructions for use under the link. This will be delivered to the specified address within 7 days after the order is received.

The product “Myo Plus” is referred to as the product below.
13E520 Basic-UDI-DI: 40644110000000013E520JT
13E400 Basic-UDI-DI: 40644110000000013E400JG
13E401 Basic-UDI-DI:40644110000000013E401JJ

Intended use

Indications for use

Myo Plus is to be used exclusively for exoprosthetic fittings of the upper limbs.

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.

Indications

For patients with unilateral and bilateral amputations.
For patients with transcarpal and transradial amputation.

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.

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 professional 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 certification for the application. Additional product training courses may become necessary to qualify for app updates.

Safety

Explanation of warning symbols

WARNING Warning regarding possible serious risks of accident or injury.
CAUTION Warning regarding possible risks of accident or injury.

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 instructions. 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.

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.

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 prosthesis 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” (Cleaning and care).

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 electrode 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
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 recommended.

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.

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.

CAUTION
Incorrect electrode settings due to muscle fatigue
Injury due to faulty control or malfunction of the product.