Myo Plus

Information & Download

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 on page 2. This will be delivered to the specified address within 7 days after the order is received.

[Smartphone with camera icon]

[QR Code for downloading instructions]

[Scan Me Button]

or / or

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

[Laptop with WWW icon]

For printed copies, email: order-ifu@ottobock.com

Product Identification

The product "Myo Plus" is referred to as the product below.

• 13E520 Basis-UDI-DI: 40644110000000013E520JT
• 13E400 Basis-UDI-DI: 40644110000000013E400JG
• 13E401 Basis-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 Symbol]: Warning regarding possible serious risks of accident or injury.
• [Caution Symbol]: Warning regarding possible risks of accident or injury.

Structure of the safety instructions

[Warning Symbol] 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 Symbol] 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 Symbol] 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 Symbol] 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 Symbol] 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 Symbol] 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 Symbol] 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 Symbol] 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 Symbol] 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 Symbol] 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 Symbol] 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 Symbol] 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 Symbol] 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 Symbol] 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 Symbol] 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 Symbol] 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 Symbol] Incorrect electrode settings due to muscle fatigue

Injury due to faulty control or malfunction of the product. The patient should take breaks during calibration.

[Caution Symbol] 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).