Otto Bock Myoelectric Forearm Prosthesis User manual

Instructions for use
Myoelectric
Forearm Prosthesis
- Custom-made device -

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Foreword1 4.........................................................................................................................
Description of the Design and Individual Components2 4.............................................
Areas of Application and Usage Restrictions3 5.............................................................
Medical and Therapeutic Aspects4 5................................................................................
Safety5 5...............................................................................................................................
Explanation of warning symbols5.1 5..............................................................................
General safety instructions5.2 5....................................................................................
Handling6 6..........................................................................................................................
Check6.1 6.................................................................................................................
Donning6.2 6..............................................................................................................
Wearing of the Prosthesis6.3 7.....................................................................................
Doffing6.4 7................................................................................................................
Charging the Prosthesis6.5 8........................................................................................
Cleaning and Care7 8..........................................................................................................
Maintenance8 9...................................................................................................................
Disposal9 9...........................................................................................................................
Legal information10 9...........................................................................................................
Liability10.1 9...............................................................................................................
Table of contents
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1 Foreword
INFORMATION
Date of last update: 2021-04-28
►Please read this document carefully before using the product and observe the safety
notices.
►Obtain instruction from the qualified personnel in the safe use of the product.
►Please contact the qualified personnel 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.
2 Description of the Design and Individual Components
Your prosthesis primarily consists of a custom inner socket which fits over your residual limb and
the covered outer socket which connects to the System Electric Hand.
A consistently good fit of your prosthetic socket can only be maintained if the volume of your
residual limb remains constant. Further information is found under volume fluctuations in Section
4 "Medical and Therapeutic Aspects".
In accordance with your indications and personal requirements, you have received a prosthesis of
the following design:
Liner: A custom liner improves the connection between your residual limb and the prosthesis.
System Electric Hand: The System Electric Hand is used to perform gripping functions. It con
tains the drive unit (electric motor, gear), sensors if applicable and the control unit. The inner
hand covers the technical components and, together with the individual cosmetic glove, creates a
natural appearance. The quick-disconnect wrist allows you to exchange the System Electric Hand
for a gripper.
INFORMATION
The System Electric Hand features an on/off switch. Turn off the System Electric Hand to pre
vent unnecessary power consumption or accidental opening of the hand.
Electrodes: The inner socket electrodes on the skin capture the myo-signals from the residual
limb muscles and amplify them as socket impulses for the electric motors. The Ottobock team has
made individual adjustments to meet your requirements.
Batteries: The prosthesis is powered by a 6/7.2 volt battery (4.8 volt in children’s prostheses).
The battery is installed in a receptacle or integrated in the prosthesis.
INFORMATION
Ottobock recommends keeping a charged battery on hand at all times, since one battery may
not be sufficient for a full day of operation (depending on the amount of use). For integrated bat
tery systems, Ottobock recommends charging the battery every night.
Battery charger: The charger is used to charge the built-in lithium-ion battery. It must be connec
ted to a 110-V or 220-V mains outlet. For more information please refer to the battery charger
instructions for use.
Cosmetic glove: The cosmetic glove gives the prosthetic hand a natural appearance by imitating
the anatomical structures. For more information please refer to the cosmetic glove instructions for
use.
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3 Areas of Application and Usage Restrictions
Your prosthesis serves as a functional and cosmetic replacement for the amputated limb and
enables you to grasp, hold, and carry objects.
The use of your prosthesis and the performance you will be able to achieve depends on your indi
vidual diagnosis, the residual limb conditions and your mobility grade. Please consult your doctor
regarding the daily duration of use and potential therapeutic measures (e.g. occupational therapy
or physical therapy) to improve your performance.
In general, you should not experience too much discomfort when wearing your prosthesis.
Excessive pressure can lead to complications.
4 Medical and Therapeutic Aspects
As a general rule, leisure activities involving movement and special physiotherapy are recommen
ded in order to maintain and improve the functionality of the residual limb. Please discuss all
measures for maintaining and improving residual limb functionality as well as residual limb treat
ment and hygiene with your doctor. Depending on your specific indications, complications can
occur in individual cases. This may restrict your ability to wear the prosthesis.
Residual Limb Treatment and Hygiene
Caring for your residual limb on a daily basis is essential. Washing your residual limb with skin-
friendly soap can prevent skin problems. Use special care products such as Derma Prevent,
Derma Repair and Derma Clean.
Volume Fluctuations
A consistently good fit of the socket of your prosthesis and good electrode contact can only be
maintained if your residual limb volume remains constant. Please wear your prosthesis regularly.
Minor volume fluctuations over the course of the day are normal.
To avoid swelling of your residual limb when you are not wearing the prosthesis, it is important to
compress the residual limb by applying a compression sock, standard liner or residual limb band
ages.
If you have additional questions regarding volume fluctuations, please consult your doctor or
prosthetist.
5 Safety
5.1 Explanation of warning symbols
CAUTION Warning regarding possible risks of accident or injury.
NOTICE Warning regarding possible technical damage.
5.2 General safety instructions
CAUTION!
Risk of injury and risk of product damage
►Keep the product away from open flames, embers and other sources of heat.
NOTICE!
Risk of product damage and limited functionality
►Do not expose the product to prohibited environmental conditions (see instructions for use of
the individual components).
►Check the product for damage if it has been exposed to prohibited environmental conditions.

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►Do not use the product if it is damaged or in a questionable condition. Take suitable meas
ures (e.g.cleaning, repair, replacement, inspection by the manufacturer or a specialist work
shop).
►Use the product carefully and as intended.
►Do not make any changes to the product.
6 Handling
6.1 Check
CAUTION
Use of a worn or damaged prosthesis
Restricted support or injuries due to changes in or loss of functionality
►Before each use, check the prosthesis for functional reliability and for possible wear or dam
age.
►If the prosthesis or a component of the prosthesis shows any signs of wear (e.g. tears,
deformations, poor fit) or damage, the prosthesis should no longer be used.
CAUTION
Volume fluctuations of the affected limb or problems with the fit (e.g. caused by growth)
Injuries, friction, pressure sores, circulatory disorders and paralytic symptoms caused by prob
lems with the fit
►If the product is fitted during the growing phase, it must be adjusted according to changing
body dimensions.
►Check the skin daily for damage and sensitivity disturbances (visually and by palpitating).
►Please consult your doctor or prosthetist in case of any signs of skin damage, even if they
are only minor.
Please verify that your prosthesis is undamaged and functional prior to each use.
Every time you put on your prosthesis, verify that the prosthesis is firmly in place by pulling on it.
First-time users in particular have to learn how to handle the prosthesis. Donning and doffing of
the prosthesis and, above all, separate use of the respective muscle groups requires practice
(e.g. with occupational therapy). Your doctor, physiotherapist or prosthetist can provide you with
additional advice on prosthesis training.
Special attention was paid to the materials used for your prosthesis. They were tested for skin tol
erance. If skin changes develop on your residual limb, please consult your doctor in a timely man
ner.
6.2 Donning
CAUTION
Improper handling
Risk of injury due to uncontrolled movements of the prosthesis
►The prosthesis must always be switched off for donning and doffing.
Different fitting options (harness, liner) result in different approaches for donning and doffing. The
best technique for your individual case has been chosen for you.
Your Ottobock team instructed you in how to put on the prosthesis. The following donning tech
nique is well proven:
Prosthesis without Liner:
1) Apply the pull-in sock/Easy-Proth® arm.
2) Pull the end of the pull-in sock/Easy-Proth® arm to the outside through the tube situated at the
bottom of the socket.

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3) Pull the soft tissue into the prosthetic socket little by little until the pull-in sock can be
removed.
Prosthesis with Liner:
1) Apply donning spray to the outside of the liner if necessary (this only applies to pure silicone
liners or liners without a fabric cover). Turn the liner inside out completely.
2) Evenly roll the liner over your residual limb. Avoid soft tissue displacement, the formation of
wrinkles and air inclusions.
3) Slide the prosthetic socket over the residual limb.
4) Please also observe the additional information in the liner instructions for use/patient informa
tion.
Switch off and remove the prosthesis if it does not fit properly. Try donning the prosthesis again.
Contact your prosthetist in case of any problems.
6.3 Wearing of the Prosthesis
WARNING
Operation of motor vehicles
Risk of accidents due to restricted body function
►Observe the applicable legal and insurance regulations for the operation of motor vehicles
and have your driving ability examined and certified by an authorised agency.
WARNING
Charging the battery while wearing the prosthesis
Risk of injury due to electric shock
►Switch off the prosthesis and take it off before charging the battery.
CAUTION
Excessive strain on load-bearing components
Injuries due to breakage of load-bearing components
►Sports activities are only permitted after consultation with your doctor or orthotist.
►If the product has been exposed to extreme strain (e.g. due to falling), take any necessary
measures (e.g. repair, replacement, inspection by the manufacturer's customer service
etc.).
6.4 Doffing
NOTICE
Improper storage of the prosthesis
Damage to hand sensors due to improper storage
►Ensure that the System Electric Hand is slightly opened at rest.
Prosthesis without Liner:
1) Pull the skin in the armpit area slightly out of the prosthetic socket.
2) Slide off the prosthesis.
Prosthesis with Liner:
1) Release the connection between the liner and prosthesis; then remove the prosthetic socket.
2) Roll the liner off your residual limb.

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6.5 Charging the Prosthesis
NOTICE
Incorrect battery charging
Damage to the battery charger, damage to the battery due to user error
►When charging the battery, only use battery chargers that have been approved by Ottobock.
►Only use original batteries.
►Observe the information in the instructions for use of the battery charger.
Charge the prosthesis as described in the instructions for use of the battery charger and/or in the
instructions for use of the battery.
INFORMATION
If a charging time of 4-5 hours does not result in improved functionality, please consult your
prosthetist. Turning the prosthesis off during longer periods of passive use will make the battery
last longer.
7 Cleaning and Care
CAUTION
Use of unsuitable cleaning agents or disinfectants
Impairment of functionality and damage due to incorrect cleaning agents or disinfectants
►Only clean the product with the approved cleaning agents.
►Only disinfect the product with the approved disinfectants.
►Observe the instructions for cleaning and care.
Your prosthesis, especially the inner socket and liner, requires regular cleaning.
Prosthesis
Cleaning with a damp cloth will generally be sufficient. Ottobock recommends Derma Clean to
disinfect the prosthesis. Clean any plastic surfaces with water and skin-friendly soap. Dry the
cleaned areas thoroughly. Do not place the prosthesis on a radiator or other heat source. Ensure
that no soap residue is left on the prosthesis, since this could cause skin irritation on the residual
limb.
Liner
INFORMATION
Remove substances that have penetrated the surface by weekly boiling. Boil your HTV silicone
liner for 1–2 hours; this sterilises the liner.
Clean the liner after every use (at least once daily).
Turn the liner inside out. Wash the liner under running water at body temperature using Ottobock
Derma Clean. Dry the liner with a towel. Accumulation of sweat can cause damage to the liner.
The service life of the product can be extended by regular cleaning. Clean any plastic surfaces
and the skin on your residual limb with water and skin-friendly soap. Dry the cleaned areas thor
oughly. Do not place the liner on a radiator or other heat source. Ensure that no soap residue
remains on the liner since this could cause skin irritation on your residual limb.
Cosmetic Glove
Use the supplied cleaning agent for the cosmetic glove.
Please consult your doctor if you have any questions on skin diseases or disinfection methods.

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8 Maintenance
CAUTION
Lack of or insufficient maintenance
Injuries due to changes in or loss of functionality
►Observe the specified maintenance intervals.
In the interest of your own safety, you should observe the check-up dates established with your
prosthetist in order to avoid any damage to your prosthesis.
The Ottobock team recommends a
maintenance interval of: ……………..
In addition, please pay attention to any changes that may become evident in the material of your
prosthesis, especially in regards to the System Electric Hand.
Please contact your prosthetist immediately if any changes occur.
9 Disposal
In some jurisdictions it is not permissible to dispose of the product with unsorted household
waste. Improper disposal can be harmful to health and the environment. Observe the information
provided by the responsible authorities in your country regarding return, collection and disposal
procedures.
10 Legal information
All legal conditions are subject to the respective national laws of the country of use and may vary
accordingly.
10.1 Liability
The manufacturer will only assume liability if the product is used in accordance with the descrip
tions and instructions provided in this document. The manufacturer will not assume liability for
damage caused by disregarding the information in this document, particularly due to improper
use or unauthorised modification of the product.

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