Aether Biomedical Zeus User manual

Instructions For Use
Version 3.0 / 2023.07.14
For Qualied Personnel

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U01DC-0301 IFU-EN
Instructions For Use Aether Biomedical
3ZEUS
3INTENDED USE
4PATIENT POPULATION
4SAFE USAGE
5TECHNICAL SPECIFICATION
7SCOPE OF DELIVERY.
7ZEUS GRIPS
8Opposed Grips
11 Non-opposed Grips
14 Moving the thumb
15 Changing grips
17 INTERFACE WEB APPLICATION
18 CONTROL METHOD
20 WARRANTY AND COMPATIBILITY
20 Compatibility
20 Warranty
Table of Contents

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21 Cleaning
21 Maintenance
22 SAFETY AND WARNINGS
22 Hand
23 Troubleshooting
24 Regulatory Compliance
25 SYMBOLS
27 EMC LABELLING INFORMATION
32 REPORTING
Warning!
○We highly recommend reading this document carefully
before using the prosthesis.
○This document contains information about the proper
and safe use of the prosthesis.
○We highly recommend keeping this document for the
whole period of using prosthesis.
○If you have any questions about the product please
contact us on [e-mail]
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Instructions For Use Aether Biomedical
Zeus
Zeus ( Zeus v1 Articial Bionic Prosthetic hand; Zeus The Bionic Hand)
is a multi-articulating myoelectric hand combining ease of control
with an elegant, robust design. The ngers and thumb provide a rm
grasp to perform everyday tasks with ease. The ngers stall individu-
ally, allowing them to conform to the shape of the object, regardless
of shape or size.
Read this document carefully before tting Zeus.
Intended Use
Zeus is an external prosthetic hand intended to be used alone or
with other appropriate upper limb components to form a comple-
te arm prosthesis, to be tted only by qualied and certied
clinicians. It should be used only by upper limb amputees and by
people with congenital absence of an upper limb. Zeus is suitable
for 3 amputation levels: below-elbow, above-elbow and shoulder
disarticulation, but the nal decision whether Zeus should be used
belongs to qualied medical personnel. Its functionality covers most
hand movements.
Zeus, including the socket (made by CPO/CP) is designed for only
one person during the whole lifetime of the prosthesis.
Fitting of the product to the patient’s upper limb may be exclusively
done by a qualied and certied CPO/CP.
Zeus is designed for mild to moderate activities.
Indications
○Amputation level below-elbow, above-elbow and shoulder
disarticulation
○For unilateral or bilateral amputation
○Congenital limb deciency of the forearm or upper arm
○The patient must be able to understand usage and safety
messages and put them into practice

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Aether Biomedical Instructions For Use
Patient Population
Safe Usage
Zeus is recommended for:
○Adults only
○All genders
○Age 18-65
Zeus is not recommended for:
○Children under age 18
○People with cognitive decits
○Please avoid use in situations with heavy loads, vibrations or
impacts.
○Zeus is developed for everyday use and must not be used for
unusual activities. These unusual activities include, for example,
sports with excessive strain and/or shocks to the wrist unit
(pushups, downhill. mountain biking) or extreme sports (free
climbing, paragliding, etc.).
○Furthermore, the Zeus should not be used for the operation of
motor vehicles, heavy equipment (e.g. construction machines),
industrial machines or motor-driven equipment.
○The prosthesis is intended exclusively for use on one patient.
Use of the product by another person is not approved by the
manufacturer.
Contraindication

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U01DC-0301 IFU-EN
Instructions For Use Aether Biomedical
78.68lbf
112.40lbf
Technical Specification
Force on chassis
(static, supporting the hand)
Force with closed hand
(static, carrying a bag)
500N
350N
Grip force
152N / 34.17lbf
Closing time
1.2sec
Device weight
with QWD
590 g/ 1.3lbs
Height
(nger tip to wrist base)
Palm Width
Thickness
172mm / 6.77in
86mm / 3.38in
30.5mm / 1.20in
Avoid pressure on thumb
!
Max. weight supported on
the knuckles
90 kg / 198 Ibs over the knuckles

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Aether Biomedical Instructions For Use
Key Features
Closed loop motor control
sensing nger position and
applied force for proportional
control
Compliant fingers to prevent
breaking of nger units
5 Individually motorized
articulating digits allowing
for dexterity in movement
Opposable thumb
12 Selectable
grip patterns
The strongest bionic hand
(152N grip force)
Closing speed 1.2 seconds
Modular design
all repairs can be done
under 30 minutes
Operating Range Storage Range
-5°C to +45°C -25°C to +70°C
(at home – between uses)
15% to 93% RH (non-condensing)
Up to 93%
700 hPa to 1060 hPa
Temperature: Temperature:
Humidity:
Humidity:
Pressure:

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Scope of delivery
Zeus Grips
You can choose from 12 grip modes. The hand has two selectable
thumb positions: opposed and non-opposed.
○Opposed thumb in opposition to the ngers on the hand allows
choosing grips like Tripod and Power.
○Non-Opposed thumb parallel with the ngers of the hand allows
grips like Key and Finger Point
○The speed and force applied by the ngers can be modulated on
the basis of EMG signal.
Zeus V1 is available in left and right-hand congurations.
The following components are provided along with the Zeus hand:
1. Accessories Kit (AC-01-T)
2. Instruction for use (U01DC-0301 IFU-EN)
3. User Guide (U01DC-0101)
4. Software instructions (U01SW-0100)
5. Quick start guide for clinicians (U01DC-0201)
6. Zeus congurator web application v 1.5.1 or higher
Model No.
A-01-L-T
A-01-R-T
Product
Zeus hand - Left
Zeus hand - Right

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Aether Biomedical Instructions For Use
Opposed Grips
Power
Grip
Trigger
Grip
In this grip, the
thumb is opposed,
while all of the
ngers can be closed until they
meet the object or no further
close signal is given. The strong
grip provides 152N of force spread
over all four ngers and thumb.
This multi-purpose grip allows you
to open a door or shake hands.
Individual nger stalling means
the grip conforms to the shape
of the object so that you can lift
things such as a wine glass. Thanks
to advanced sensors, the hand
optimizes the force applied to the
object.
This grip is useful
for operating
appliances which
require trigger mechanisms
like sprays. The hand grasps
the object and conforms to the
shape of the object The index
nger and middle nger are
controlled proportionately to
operate the trigger mechanism.
The speed and force applied by
the index nger can be modulat-
ed on the basis of EMG signal.

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Precision
Open
Grip
Precision
Closed
Grip
In this grip,
the thumb
moves to
a mid-point
and stops. The
index nger
can be controlled proportional-
ly to form a pinch. Middle, ring
and little ngers remain open.
This grip can be used for picking
up small delicate objects and
various precise activities.
In this
grip,
the thumb
moves to a
m i d - p o i n t
and stops. The index nger can
be controlled proportionally to
form a pinch. Middle, ring and
little ngers close fully. This
grip can be used for picking up
small objects from a table.

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Aether Biomedical Instructions For Use
Tripod
Closed
Grip
Tripod
Open
Grip
The grip
a l l o w s
you to
hold medium
sized objects
such as a pen,
car keys and eggs. The thumb
assumes a midpoint position while
the index and middle nger move
proportionally to reach the tip of
the thumb. The ring nger and
little nger close fully.
T h i s
grip allows
you to hold
a variety
of daily life
objects like a
pen, car keys
and eggs. The thumb assumes
a mid-point position while the
index and middle nger move
proportionally to reach the tip
of the thumb. The ring nger
and little nger remain open.

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Instructions For Use Aether Biomedical
Non-Opposed Grips
Finger
Point
The index nger is active and in a pointing
position with the rest of the ngers closed.
This can be used for pushing switches and buttons.
Active
Index
The index nger is active and in a pointing
position with the rest of the ngers open.
This can be used for working on computer
keyboard, typing.

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Aether Biomedical Instructions For Use
Open
Palm
Hook
Grip
The hand opens to the extent where it
provides a slight curvature to support
plates, bowls and books. The rubberized palm provides a at,
non- slippery surface to condently carry objects in this grip.
This grip is used for lifting up heavy objects
like briefcases, shopping bags and gym equip-
ment. Because of the self-locking nature of
Zeus, the ngers have a static grip capacity of 35kgs, allowing
you to lift heavy objects with ease. This grip can also be used
to provide support when getting up from a seated position.

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Key
Grip
This is a commonly used grip for picking up thin at
objects, holding a key or turning a page. The four ngers
assume a position to provide a at platform for the
thumb. The thumb can be controlled proportionately
to open and close.
Mouse
Grip
This grip is used to operate a computer
mouse. The hand assumes the position of the
mouse. The index nger and the middle nger can be
controlled to push left and right buttons respectively.

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Aether Biomedical Instructions For Use
Moving the thumb
To move the thumb from the non-opposed to the opposed position,
please hold the thumb at its base with your free hand and push it
steadily inwards in a controlled manner.
To move the thumb from the opposed to the non-opposed position,
please hold the thumb at its base with your free hand and push it
steadily outwards in a controlled manner.
Opposed ▶
▶Opposed
▶Non-opposed
Non-opposed ▶

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Changing grips
There are 2 different modes to change grips.
Sequential mode
In the sequential mode you can cycle between the grips in the loop.
Using the primary grip change signal you go forward in the loop;
using the secondary grip change signal, you go back. The grips are
split into two groups: with the thumb opposed and non-opposed.
To switch between the groups, you need to manually adjust the
thumb position and generate a grip change signal or a secondary
grip change signal.
Pairing mode
In the pairing mode, the grips are arranged in a hierarchical manner,
allowing for quick access. The rst level of division is based on the
position of the thumb. When the thumb is in the opposed position,
the opposed group of grips is active and when the thumb is in the
non-opposed position, the non-opposed group of grips is active.
○To switch between the opposed group of grips and the non-op-
posed group of grips, the user has to move the thumb in the
desired position and then provide a Change Signal.
○Within each group of grip, there are two subgroups - the prima-
ry group and the secondary group. Each subgroup has two grips
within it, the default grip and the alternate grip.
○To switch between the default grip and the alternate grip,
provide a Change Signal.
○To switch between the subgroups, primary group and the
secondary group, provide a Secondary Change Signal.
○When you change the position of the thumb, provide a Change
Signal to allow the prosthesis to change between the opposed
and non-opposed group of grips.
○REMEMBER This works only with Control Modes - Pairing Mode.

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Aether Biomedical Instructions For Use
○To switch between opposed and non-opposed grips, it is neces-
sary to change the thumb positon accordingly and provide a
Change Signal. The grip pairings can be represented as follows:

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Instructions For Use Aether Biomedical
Interface Web Application
C l i n i c i a n s a r e g r a n t e d a c c e s s t o t h e w e b Z e u s c o n  g u r a t i o n
application.
The software is designed for prosthetists to make change in the Zeus
setting to ne-tune functions for users.
The Interface software is designed for use only by qualied and Zeus
certied prosthetists. Users of the prosthesis are not allowed to make
any changes in it.
Using this application the practitioner is able to: control the EMG
settings for controling Zeus, choose grips available to the user,
modify the nger positions for each grip and activate more advan-
ced functions of the prosthesis.
Prosthetists should refer to the Software instructions (U01SW-
0 1 0 0 ) p r o v i d e d b y A e t h e r B i o m e d i c a l t o u s e t h e s o f t w a r e a n d t o
understand the process of connecting the device with a computer.

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Aether Biomedical Instructions For Use
Control Methods
The three types of possible signals detected by sensors include:
1. Open-contraction of extensor muscles.
The 2-channel sensor system might be placed differently, depending
on the user accessibility.
2. Close-contraction of exor muscles.
T h e t a b l e b e l o w s h o w s w h a t t y p e o f s i g n a l i s t r e a t e d a s
primary Change Signal and Secondary Change Signal in different
grip switching modes.
3. Co-contraction - Contraction of both
exor and extensor muscles simulta-
neously. It can be compared to making
a st, or trying to open and close the
hand at the same time if the sensors
are placed on the forearm of the user.
Grip switching mode Primary Change Signal Secondary Change Signal
Co-contraction Co-contraction Long co-contraction
Open-open Open open Open open open
Hold-open Hold open Long hold open
Single electrode Open open
(single electrode)
Open open open
(single electrode)

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Zeus actively measures the EMG signal to look for the grip Chan-
ge Signal (CS) and the grip Secondary Change Signal (SCS). These
signals are used to switch between chosen grips. The practitioner can
select which action is treated as the CS and the SCS by selecting grip
switching mode from the following options in the web application:
○Co-contraction - impulse of the co-contraction signal is treated
as CS and holding co-contraction for the period specied in
software (default 0.5s) is treated as SCS.
○Open-open - to generate CS, a user needs to make 2 short,
consecutive impulses of the open signal. To generate SCS, a user
has to make 3 short consecutive impulses of the open signal.
○Hold-open - holding the open signal above the specied
threshold for longer than 1.5s (possible to change in the software)
when the grip is fully opened is treated as a CS. Holding the open
signal above the specied threshold for longer than 3s (possible
to change in the software) when the grip is already fully opened
is treated as a SCS.
○Single electrode - this grip switching mode works with a one
channel sensor system. It treats 2 short, consecutive impulses of
the signal as CS and 3 short, consecutive impulses of the signal
as SCS.
Also a user can quickly switch between grips: tripod closed and
tripod open, precision closed and precision open, nger point and
active index. To do this he needs to hold an open signal for a longer
period, with the active ngers fully open, until all of the ngers open.
To switch from the open variant of grip to closed variant he needs to
hold a close signal, with the active ngers fully closed, until all of the
ngers close.