Aether Biomedical Zeus User manual

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MSD-14 ZEUS The Bionic Limb-Terms and Conditions v 1
“ZEUS the bionic limb
–Terms and Conditions”
binding as of 1st June 2022
1. GENERAL INFORMATION
1.1. Introduction
This document sets forth the terms and
conditions for the use of Zeus and contains
information on:
(a) Zeus intended use,
(b) support and training,
(c) maintenance and servicing,
(d) warranty terms,
(e) regulatory compliance and certification,
(f) manufacturer’s liability.
1.2. About Company
Aether Biomedical sp. z o.o. –a manufacturer
of Zeus the bionic limb –is a medical robotics
company focused on biosignal processing and
bionic limbs for upper limb amputees.
1.3. Product Description
Zeus is a multi-action bionic limb combining
ease of control with elegant, robust design.
2. DEFINITIONS
Unless otherwise expressly provided to the
contrary in these Terms and Conditions, all
capitalized terms used herein shall have their
respective meanings set forth below:
Aether or
we
means Aether Biomedical sp. z
o.o. (polish limited liability
company) with its registered
office in Poznan, address: ul.
Krolowej Jadwigi 43, 61-871
Poznan, entered into the
register of entrepreneurs of the
National Court Register Poznan
–Nowe Miasto i Wilda, VIII
Commercial Division of the
National Court Register under
KRS No.: 0000755184,
REGON: 381661137, NIP:
7831791083.
Consumer
means an individual who
purchases the Product for
personal use.
Maintenance
means the process during
which all Product functions are
extensively tested, the worn
mechanical parts are replaced,
the required firmware updates
and technical updates are
performed. “Maintenance”
also includes cleaning.
Medical
Center
means a medical prosthetic and
orthotic center providing
medical services to the
Patients, authorized by Aether
to resale the Product and
provide training to the Patients
with respect to the Product.
“Medical Centers” are solely
responsible for the assembly
and installation of the Product
to the Patients, including but
not limited to calibration of the
Product, positioning of
electrodes and sensors, setup
of the Product using the
Software, and for the design
and fabrication of the
prosthetic socket. “Medical
Centers” are the first point of
contact for the Users.
Product
means the whole arm
prosthesis system combined
of: (i) (i) a multi action bionic
limb available in left hand (A-
01-L) or right hand (A-01-R)
configuration, (ii) instruction
for use (0704_IFU), (iii) user
guide (U01DC-0100), (iv)
software instruction (U01DC-
0400), (v) Quick start guide for
clinicians (U01DC-0200), (vi)
accessories kit (AC-01), (vii)
Zeus configurator web
application v 1.00 or
higher,(viii) the prosthetic
socket fabricated by Medical
Centers.
Qualified
Personnel
mean the clinical team of
certified/licensed professionals
who provide medical or
healthcare services to the
Patients at the Medical Centers,
consisting of certified
prosthetists and/or orthotists,
prosthetic assistants,
technicians and other
practitioners.
Repair
means the process during
which Aether’s qualified service
technicians or technical

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MSD-14 ZEUS The Bionic Limb-Terms and Conditions v 1
partners analyze the Product
and perform a mechanical-
functional test. Affected parts
or components are assessed
and replaced or repaired
according to Aether’s servicing
directives. In addition, service
inspections as well as cleaning
are carried out. Zeus’
“Repairs” within the scope of
Warranty are free of charge
during Warranty Period. After
Warranty Period, “Repairs” are
charged based on a cost
estimate on request.
Software
means an interface software
licensed by Aether to the
Medical Centers for Zeus
configuration. The “Software”
is designed for use only by
Qualified Personnel to for
installation, calibration and
servicing of the Product.
Terms and
Conditions
means these terms and
conditions.
User
Manual
means the document
containing important
information on the correct use
and care of Zeus which shall be
provided to the Patient in paper
form along with the Product.
Aether may update or modify
the “User Manual” from time
to time.
User,
Patient or
you
means an individual receiving
or having received preventive,
diagnostic, therapeutic,
rehabilitative, or maintenance
health services from the
Medical Center, who purchased
the Product.
Warranty
shall have the meaning set out
in clause 6.1.
Warranty
Period
shall have the meaning set out
in clause 6.3.
Zeus
means a multi-action bionic
limb available in left hand (A-
01-L) or right hand (A-01-R)
configuration, manufactured by
Aether.
3. INTENDED USE
3.1. Zeus is an external limb prosthetic component
intended to be used with other compatible system
components (including electrodes, battery
systems, connector “Quick Disconnect Wrist” and
cables) by Qualified Personnel to provide Patient
a complete arm prosthesis system (Product).
3.2. Zeus is designed to be used only by Patients with
upper limb loss or deficiency and by Patients with
congenital absence of an upper limb (forearm).
The final decision whether Zeus is suitable for the
Patient belongs to the Qualified Personnel.
Qualifications and fitting of the Product to the
Patient’s upper limb may be exclusively done by
the Qualified Personnel of the authorized Medical
Centers.
3.3. Zeus is designed for use only on one Patient
during the whole service life of the prosthesis.
Depending on the Patient’s activity the estimated
service life of Zeus is up to 5 (five) years. The
service life can be individually extended
depending on the intensity of use and by
performing regular Maintenance inspections as
set out in clause 5.5.
3.4. Zeus is designed for mild to moderate activities.
Its functionality covers most of the hand
movements. Please avoid use in situations with
heavy loads, vibrations or impacts. For more
detailed information on the intended use of
the Product please refer to the User Manual.
3.5. You shall use the Product in accordance with the
User Manual, guidelines provided during training
and in conjunction with advice from your
Qualified Personnel. Please read the User Manual
thoroughly before using Zeus. Please refer to
www.aetherbiomedical.com to ensure you are
viewing the latest version of the User Manual and
relevant Product information.
3.6. Please be aware that the Product comes with the
Software which is not intended for Patient use.
Alterations should be made by the Qualified
Personnel only.
3.7. If you have any specific questions about your
Product, please contact your Qualified Personnel
or visit the Aether website
www.aetherbiomedical.com for the latest
information and news.
4. SUPPORT AND TRAINING
4.1. The Patient must be taught how to handle, care
for and operate his/her Zeus properly. The User
Manual along with the training and support
provided by the Qualified Personnel of the Medical
Center should help the Patient understand how

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MSD-14 ZEUS The Bionic Limb-Terms and Conditions v 1
Zeus will help him/her to accomplish their
functional goals.
4.2. Patient shall be trained with Zeus by the Qualified
Personnel from the Medical Center which has sold
and fitted Zeus to the Patient.
4.3. The Qualified Personnel will assist you to become
proficient in using your Zeus. The term and scope
of training varies depending on given Patient’s
condition, activity etc. and shall be each
determined by Qualified Personnel. During the
training sessions different aspects of your
everyday activities will be explored. You can get
the most from training by listing and suggesting
those tasks that you want to achieve. Also, you
shall have discussed your functional goals with
your Qualified Personnel. You can then work
through this list with your team of Qualified
Personnel. To get the most from the Zeus, make
sure your arm is comfortable, secure and
functional.
4.4. To learn about the list of current Aether’s Medical
Centers - contact Aether via the contact form
available on www.aetherbiomedical.com.
5. MAINTENANCE AND SERVICING
5.1 Maintenance, Repairs and servicing of the
Product may only be performed by qualified
Aether’s technicians and technical partners.
Contact your local Medical Center for all service
related concerns.
5.2 You should inspect your Product regularly to
identify potential problems early. If the Product
doesn’t function as you think it should, contact
the Medical Center where you purchased the
Product which will be able to provide you
guidance.
5.3 If you experience any technical problems with the
Product and your Qualified Personnel is not
available, contact Aether via the contact form
available on www.aetherbiomedical.com.
5.4 We strongly recommend that you do not adjust,
dismantle, attempt to maintain or modify your
Product. Moreover, never attempt to open,
disassemble, modify, or repair any component of
the Product, including accessories.
5.5 To ensure Patient’s safety, proper performance of
the Product and in order to maintain operating
safety and protect the Warranty, regular
Maintenance of Zeus must be carried out, i.e.
every 6 (six) months from the date of purchase.
Your Qualified Personnel shall provide you with
the next Maintenance date.
5.6 Zeus is eligible for one free Maintenance every 6
months during the Warranty Period as set out in
clause 6.3. After Warranty Period, Maintenance is
charged based on a cost estimate on request.
5.7 Medical Center shall notify you on the obligatory
Maintenance –each every 6 (six) months.
5.8 Aether shall not liable for any malfunction of Zeus
if it is the result or is related to incorrect or
untimely perform of Medical Center’s or Patient’s
obligations with respect to Maintenance.
5.9 If Zeus is to be returned for Maintenance or
servicing, please contact your Medical Center
stating the Zeus hand’s serial number. The serial
number can be found on the part called “Quick
Disconnect Wrist”. We will issue a returns form
that shall be completed in full so your request can
be dealt with promptly.
6. WARRANTY TERMS
6.1. Limited Warranty
Aether warrants to the User (original purchaser
of the Product from Medical Center) that Zeus is
free from defects in materials and workmanship.
This Warranty applies, subject to normal wear
and tear, when Zeus is used as intended, without
unapproved modifications, following all Aether
instructions and requirements, in particular in
accordance with the User Manual; and when Zeus
is fitted by the Qualified Personnel who meet all
Aether product-specific training requirements as
needed for Zeus.
6.2. Exclusion of Warranty
This warranty does not apply if Zeus (1) was not
purchased from Aether or its authorized Medical
Center, (2) has been altered or modified in any
way, subject to any modifications performed by
Qualified Personnel which are accepted by
Aether, (3) has not been used in accordance with
the User Manual, (4) has not been maintained as
set out in clause 5.5, or (5) has been repaired or
maintained by an uncertified person, or (6) has
been programmed or controlled with unapproved,
alternative software or by unauthorized person.
This Warranty does not cover damage due to
accidents, neglect, misuse, abuse, or operation
beyond capacity, parts damaged by improper
installation, substitution of parts not approved by
Aether, or any other alteration or repair by others
that, in Aether’s judgment, materially or
adversely affects Zeus or any part thereof.
This Warranty does not apply to the Product’s
components manufactured by third parties, such
as batteries, the electrode system (the relevant

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MSD-14 ZEUS The Bionic Limb-Terms and Conditions v 1
warranty terms of the components’
manufacturers are enclosed separately) and the
prosthetic socket (manufactured by the Medical
Centers).
This Warranty is governed by Polish law and is
not transferrable.
6.3. Warranty Period
(a) The Zeus comes with a 2-year-standard
manufacturer’s Warranty from Aether.
The Warranty is effective from the date of
delivery of the Product to the User.
(b) In addition, the 3-year extension from 2-
to 5-year Warranty can be purchased at
the date of purchase of the Product.
6.4. Scope of Warranty
The Warranty includes:
(a) free of charge Repair of Zeus*;
(b) free of charge replacement unit for the
period of Repair and Maintenance during
the Warranty Period.
* Repairs do not cover superficial damage, such
as scratches indicating signs of use.
6.5. Reporting Warranty claims and returning
Products
To obtain the benefits of this Warranty, any
suspected defect must both be reported to the
Medical Center and the affected Product must be
delivered to Medical Center where you purchased
the Product within 7 (seven) days of the defect
having occurred within the Warranty Period.
When returning a Product for any reasons
specified in this Warranty, the entire Product
must be returned in the original packaging to
ensure safe transport.
Where a claim is made under Warranty, this claim
must be supported by appropriate
documentation.
In the event you do not receive satisfactory
Warranty service, contact Aether contact Aether
via the contact form available on
www.aetherbiomedical.com. Provide the name of
Medical Center from which you purchased your
Product, copy of commercial invoice on
purchasing Zeus, address, date of purchase,
indicate nature of the defect and the Zeus’ serial
number. Do not return any Products to Aether’s
location without prior consent.
6.6. Components
The manufacturers of the Product components,
such as the battery and the electrode system
provide their own warranty terms, as attached
hereto as Schedules.
Upon prior consent of Aether, Medical Centers
may decide to use other Product’s components
than the ones provided by Aether (inter alia:
battery, electrodes system). Before of any use of
such components, Patient shall receive form
Medical Center the warranty terms for such
alternative components implemented by the
Medical Centers.
6.7. Warranty disclaimer
THE EXPRESS WARRANTY SET FORTH
HEREINABOVE IS EXCLUSIVE AND IN LIEU OF
ANY OTHER WARRANTIES WHATSOEVER,
WHETHER EXPRESS, IMPLIED OR STATUTORY,
INCLUDING, BUT NOT LIMITED TO, THE IMPLIED
WARRANTIES OF MERCHANTABILITY OR
FITNESS FOR A PARTICULAR PURPOSE, AND ALL
SUCH OTHER WARRANTIES ARE HEREBY
DISCLAIMED AND EXCLUDED BY AETHER. TO
THE MAXIMUM EXTENT PERMITTED BY LAW THE
SOLE REMEDY FOR VIOLATIONS OF ANY
WARRANTY WHATSOEVER, SHALL BE LIMITED
TO REPAIR OF THE DEFECTIVE ZEUS HAND
PURSUANT TO THE TERMS CONTAINED HEREIN.
IN NO EVENT SHALL AETHER’S LIABILITY OF ANY
KIND INCLUDE ANY SPECIAL, INCIDENTAL OR
CONSEQUENTIAL DAMAGES, EVEN IF AETHER
SHALL HAVE BEEN ADVISED OF THE
POSSIBILITY OF SUCH POTENTIAL LOSS OR
DAMAGE.
This Warranty gives the Consumer specific legal
rights. The Consumer may also have other legal
rights which vary from country to country. Some
countries and states may not allow the exclusion
or limitation of incidental or consequential
damages or warranties, so the above limitations
or exclusions may not apply to you. This
Warranty shall be extended to comply with
state/provincial laws and requirements.
7. REGULATORY COMPLIANCE AND
CERTIFICATES
7.1 We declare that we meet the appropriate
European quality standards for design,
manufacture and supply of prosthetic products
and user software. Continued compliance with
these standards is monitored by a program of
internal audits.
7.2 As a manufacturer of medical equipment, we are
following the strict requirements of the Medical
Devices Regulation 2017/745 (MDR), and the Act
of 7 April 2022 on the Medical Device.

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MSD-14 ZEUS The Bionic Limb-Terms and Conditions v 1
7.3 Our Products are entitled for the CE sign and all
individual Products are marked indicating that
they comply with the requirements of the
abovementioned Regulation 2017/745. The “CE”
mark may be applied on packaging or
accompanying documents, rather than the
Product itself.
7.4 Zeus and its associated components listed in this
document are covered by test certificates for:
Applicable standards:
(a) EN 60601-1
(b) EN 60601-1-2
(c) EN 60601-1-11
(d) EN 62366
(e) EN ISO 14971
(f) IEC 62304
(g) EN 1041
Applicable EU Harmonised Regulation:
(a) Medical Device Regulation 2017/745
(b) RoHS Directive 2011/65/EU
(c) WEEE Directive 2012/19/EU
8. LIMITATION OF LIABILITY
8.1. Aether is solely liable to the Users for the
technical and functional aspects of the Zeus.
8.2. Aether explicitly states that Zeus may only be
used under the specified conditions and for the
intended purpose, and in combination with
components provided in the Product kit (as
described in the definition of the “Product” set out
in section 2) or other components that were
authorised by Aether, and in accordance with
User Manual. Aether does not assume liability for
damage caused by component combinations that
were not authorised by Aether. Use of
unauthorized components in conjunction with
Zeus will void any warranty or other obligation,
express or implied, of Aether.
8.3. Aether shall not be liable in any way for any
damages or injuries caused by improper use of
the Product.
8.4. Aether disclaims any liability related to medical
decisions made by the Qualified Personnel, any
failures in the assembly or installation of the
Product to the Patient or improper training
provided by the Qualified Personnel.
8.5. Some jurisdictions do not allow the limitation or
exclusion of liability for certain types of damages.
Accordingly, some of the above disclaimers and
limitations may not apply to you. To the extent
that Aether may not, as a matter of applicable
law, disclaim or limit its liability as set forth
herein, the extent of Aether’s liability shall be the
minimum permitted under such applicable law. In
particular, nothing in these Terms and Conditions
shall affect the statutory rights of any Consumer
or exclude or restrict any liability for death or
personal injury arising from any negligence or
fraud of Aether.
9. FINAL PROVISIONS
9.1. Amendments to the Terms and Conditions
Aether may update or modify these Terms and
Conditions from time to time. The current version
of Terms and Conditions may be found at:
www.aetherbiomedical.com.
9.2. Questions, inquires or comments
Any questions, inquiries or comments regarding
the Product may be sent by e-mail at:
[email protected].
9.3. Severability
If any portion of these Terms and Conditions is
found illegal or unenforceable, in whole or in part
by any court of competent jurisdiction, such
provision shall, as to such jurisdiction, be
ineffective solely to the extent of such
determination of invalidity or unenforceability
without affecting the validity or enforceability
thereof in any other manner or jurisdiction and
without affecting the remaining provisions of
these Terms and Conditions, which shall continue
to be in full force and effect.
9.4. Governing law
To the extent permitted by applicable law, these
Terms and Conditions are governed by and
construed in accordance with the laws of Poland,
without regard to conflict of law provisions.
Except where prohibited and without limitation to
any statutory rights for Consumers, you agree
that the courts of Poland shall have exclusive
jurisdiction to settle any dispute or claim that
arises out of or in connection with these Terms
and Conditions or its subject matter.