Tyromotion OMEGO Basic User manual

OMEGO®Basic
GEBRAUCHSANWEISUNG / MANUAL
Sprachen / Languages: Deutsch (DE), English (EN)
Ausgabedatum der Gebrauchsanweisung: 02 Juli 2018 / Issuing Date of User Manual 2st July 2018

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Contact information:
Manufacturer:
TYROMOTION GmbH
Bahnhofgürtel 59
8020 Graz
AUSTRIA
TEL [phone]
FAX [phone]
MAIL [email protected]
WEB www.tyromotion.com
SUPPORT [email protected]om
Distributor (Germany, Switzerland):
TYROMOTION GmbH
Bahnhofgürtel 59
8020 Graz
AUSTRIA
TEL [phone]
FAX [phone]
MAIL [email protected]
WEB www.tyromotion.com
SUPPORT [email protected]om
Distributor (Belgium):
Arseus Medical
Rijksweg 10
2880 Bornem
BELGIUM
TEL [phone]
MAIL [email protected]
WEB www.arseus-medical.be
SUPPORT [e-mail]

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Table of contents
Introduction 5
1.1 Introduction 5
1.1.1 Regarding the usage of this documentation 5
1.1.2 Symbols in the user manual 5
1.1.3 System content 6
1.1.4 The pre-gait therapy system 6
1.1.5 Intended purpose 7
1.1.6 Notices 8
1.1.7 Safety 8
1.1.8 Warnings 8
1.1.9 Owner’s responsibility 14
1.1.10 Error and omissions 15
1.1.11 Property of TYROMOTION GmbH 15
1.1.12 Warranty and legal disclaimer 15
1.2 Training concept 16
1.3 Symbols on OMEGO® Basic 18
1.3.1 Type label 19
Technology 20
2.1 Technology 20
2.1.1 Overview 20
2.1.2 Usage area 25
2.2 The OMEGO® Basic System 27
2.2.1 Power supply OMEGO® Basic 29
2.2.2 Installation 29
2.2.3 Repair 29
2.2.4 Disposal –Customer informatin 29
2.3 OMEGO® Basic adjustment options 30
2.3.1 Height adjustment of the monitor handle bracket 30
2.3.2 Pedal radius adjustment 31
2.3.3 Foot rest replacement 32
2.3.4 ALL-IN-ONE PC adjustment 34
2.4 Wheelchair positioning 35
2.4.1 Fastening/unfastening the tilt protection 35
2.5 Device setup and movement 38
2.6 Monthly functionality check/Recurring check 39
2.6.1 Functionality checklist 39
2.6.2 Recurring check 40

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Preparation / Basics 41
3.1 Set-up and assembly 41
3.1.1 Assembly 41
Clinical application 44
4.1 Indications/Contraindications 44
4.2 Safety 47
4.2.1 Safety concept 47
4.2.2 Residual risk 49
4.3 Prior to training 50
4.3.1 Activating the OMEGO® Basic systems 50
4.4 Application 50
4.4.1 Patient information 51
4.4.2 Securing the feet 51
4.4.2.1 Securing feet with Velcro ® straps 51
4.4.3 OMEGO Basic® Applications 53
4.4.4 Foot drop therapy applications 54
4.5 After application 55
4.5.1 Turning off the OMEGO Basic® System 55
4.5.2 Cleaning the OMEGO Basic®-Systems and accessory parts 56
4.5.2.1 Detergents and disinfectants 56
4.5.2.2 water 56
4.5.2.3 instruments 56
4.5.3 cleaning process 57

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Introduction
1.1 Introduction
We are happy to provide this user manual as an introduction for the usage of the
OMEGO®Basic pre-gait therapy systems. The following user manual addresses the
essential functions that are necessary for understanding the functionality and usage of
the OMEGO® basic system.
For more information about our products visit our website or contact us personally.
1.1.1 Regarding the usage of this documentation
It is absolutely imperative that every user completes the training
course and has read the user manual prior to using OMEGO® Basic
systems.
For legibility reasons, the following pages only refer to the male gender, which, however,
always implies the female gender as well. TYROMOTION GmbH rejects any liability for
damages to persons or material if safety regulations and instructions relevant to the
usage of the OMEGO® Basic system are not observed!
1.1.2 Symbols in the user manual
Warnings: Severe risk of injury or hazard results when this symbol is
displayed in the user manual and notices are not observed. Be especially
mindful of these notices!
Follow the user manual
Table 1

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1.1.3 System content
The OMEGO® Basic system consist of the following components, included in the delivery:
•Base unit
•All-IN-ONE PC
•2x foot rest sets
o1x set for normal Therapy (item number O.G200 and O.G201)
▪2x wide Velcro straps for foot fixation
▪2x narrow velcro straps for foot fixation
o1x set for drop foot therapy (item number O.G250 and O.G251)
▪1x set magnetic coupling for foot fixation drop foot rest
•2x tilt protection
•Power cable with 3 power plugs for various country configurations
•USB stick (with instruction manual for TyroS and OMEGO® Basic, assembly
instruction, accompanying documents, software)
•instruction manual for TyroS and OMEGO® Basic, assembly instruction,
accompanying documents
•1x hexagon screwdriver for changing the foot rests
•1x allen key for monitor mounting
•2x microfuse 16A T 250V
1.1.4 The pre-gait therapy system
The OMEGO® Basic is a mechatronic therapy system for the rehabilitation of the relevant
criteria that are necessary for walking. Pre-gait therapy is the targeted rehabilitation of
one or more prerequisites necessary for physiological walking.
The OMEGO® Basic System consists of the base unit, which contains the electrically
driven movement mechanism, the pedestal unit, the foot fixations, foot shells and a
computer-based control and operating unit for setting the therapy parameters.

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Image 1: Symbolic image: OMEGO® Basic Pre-Gait Therapy System
The OMEGO® Basic is a unique device for the rehabilitation of the relevant pre-gait
prerequisites: balance, locomotion, musculoskeletal integrity and neurocognitive
control.
Whether uni- or bilateral leg training with symmetry detection, leg press, stepper,
ergometry / cycling, vibration, sensor therapy or therapy of dorsiflexion: OMEGO® Basic
combines all functions in one device.
1.1.5 Intended purpose
The OMEGO® Basic is a robotic pre-gait therapy system for the rehabilitation of patients
with neurologic disorders. The target population includes neurologic, orthopedic,
geriatric and pediatric patients. The therapy and feedback system is used for the
rehabilitation of patients with dysfunctional conditions which are essential for gait.
Depending on national variances, typically physiotherapy utilizes the OMEGO® Basic
system as therapeutic support, enhancement and intensification in addition to
conventional therapy forms. Repetitive movement of the legs offers intrinsic and
extrinsic stimuli which promote brain reorganization. Repeated activity and training
triggers neuroplasticity and thus the alteration (adaptation) of synapses, nerve cells or
even entire cerebral areas for regaining lost functionality.

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1.1.6 Notices
Familiarize yourself with the instructions for use before using the
system and at regular intervals.
It is also mandatory to read the supplied instructions for use of the
software tyroS for the use of the system!
Give the marked notes the greatest possible attention!
Medical personnel and properly trained therapists responsible for the OMEGO® Basic
system are required to warn technicians, patients and other persons within the vicinity
of the device to fully observe the contained safety precautions. The system may only be
operated by properly trained personnel. It is imperative that each user attended training
and read the instructions before using the OMEGO® Basic system for the first time.
Ensure that the system is not manipulated by unauthorized personnel. The system is
unpacked and installed by service personnel authorized by TYROMOTION GmbH. Never
attempt to install the system by yourself.
The OMEGO® Basic system must not be changed without the
manufacturer's permission.
1.1.7 Safety
Persons who commission the OMEGO® Basic therapy system must first have read and
understood Chapters 1.1.7 and 1.1.8. Never modify the system including system
components, software, cables, etc. Modifications by users can compromise security and
affect system performance. All modifications must be made by a person qualified by
TYROMOTION. The information in Section 1.1.8 is intended to familiarize the user with
the hazards that may result from using the system and warn them of the injuries and
damage that can result if the safety precautions are not met. Users are required to
familiarize themselves with these safety instructions and to avoid conditions that could
result in injury or damage.
1.1.8 Warnings
Warnings are indicated by the symbol as depicted in chapter 1.1.2 (yellow triangle with
exclamation mark).
To ensure the applicability of this manual all warnings from the different chapters are
compiled in the following list.

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Chapter 1 warnings
Use of this documentation:
It is a prerequisite that all users attend an instruction and read the user manual prior to
using the OMEGO® Basic System for the first time.
Please note:
The OMEGO® Basic System may not be modified or adjusted in any way without the
manufacturer’s consent.
Chapter 2 warnings
Electromagnetic compatibility:
The OMEGO® Basic is a medical device and as such is subject to special safety measures
regarding electromagnetic compatibility. The following instructions are to be adhered to
at all times. Portable and mobile HF communication systems can influence OMEGO® Basic
functionalities.
Consumption of food and drinks:
The consumption of food and drinks in the device’s immediate vicinity is prohibited due
to safety reasons.
Connection of external devices:
Do not connect any external devices to free PC ports without having obtained the
necessary manufacturer information.
The mains connection at the front of the device is provided for the sole use of connecting
specified Tyromotion accessories. Do not connect any other devices or accessories!
Accessories:
Only accessories specified by the manufacturer may be used.
Hazards posed by tangible parts that are NOT application parts:
The therapist has to instruct the patient to neither hold or lean onto device parts (frame,
PC, etc.) nor touch them.

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Power supply:
WARNING: In order to avoid the risk of an electrical shock, the device may only be
connected to the power supply via a ground wire.
The system may not be connected to the power supply via extension cables.
Repairs:
Always contact the manufacturer for repairs!
Height adjustment of monitor handle bracket:
The height of the monitor handle bracket may only be adjusted by a therapist.
The height is to be adjusted slowly and taking into consideration spatial requirements as
well as the patient’s range of motion.
Always hold the handle/PC carrier tube with one hand before pulling out the catch bolt in
order to prevent the handle/PC carrier tube from falling to the ground or tilting
backwards, as this could pose a risk of injury for both the therapist and the patient or
could damage the All-IN-ONE PC!
Monitor handle jamming risk
Adjust the position of the monitor handle bracket with care and never grasp the bracket’s
locking mechanism.
Pedal radius adjustment:
Adjusting the pedal radius while the cranks are in motion or during therapy poses a
jamming hazard:
While the cranks are spinning or a therapy session is in process, neither the operator nor
any other person may modify the device’s pedal radius. Always end the therapy session
before entering the main menu for modifications.
Never attempt to modify a moving part!
Foot rest replacement:
Trying to replace the foot rests while the cranks are in motion or during therapy poses a
jamming hazard:
While the cranks are spinning or a therapy session is in process, neither the operator nor
any other person may modify the device’s pedal radius. Always end the therapy session
before entering the main menu for modifications.
Never attempt to modify a moving part!

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Wheelchair positioning:
Please make sure the wheelchair brakes have been locked before starting exercise with
the OMEGO® Basic. If you exercise with an electric wheelchair the wheelchair has to be
switched off and in braking position.
Fastening/unfastening the chair safety catch:
A spasm or particular functions (e.g. leg press) may cause the patient to fall backwards
and, in the worst case, topple over. To prevent this, always use the safety catch and/or
only use chairs that can be secured with a safety catch.
Always check the wheelchair for stability prior to therapy. If stability is not given the
therapy has to be supervised by the therapist at all times.
If a patient is unable to hold onto the handle without assistance the therapy has to be
supervised by the therapist at all times.
Device assembly and transport:
The OMEGO® Basic’s position may not be changed nor may the device be moved as long
as the legs are attached and/or in use.
Position the OMEGO® Basic on a flat surface without constant human traffic.
Never move the OMEGO® Basic when patients are in its vicinity. Be careful when moving
it over thresholds or bumps.
Monthly functionality check / recurring check:
The use of the device has to be stopped immediately in case one of the malfunctions listed
in Table 9 occurs or is suspected.
Casing damages (e.g. caused by transportation):
Never activate the device if the casing is damaged as this may have unpredictable
consequences (e.g. electric shock). Check each point listed in the checklist before
activating the device and, if necessary, contact Tyromotion.

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Chapter 4 warnings
Indications/contraindications:
Is the system suitable for the designated therapy:
1. Constant monitoring of the patient’s therapy progress.
2. Observatiob of current relevant studies.
3. Adjustment of therapy in case the patient’s condition deteriorates excessively.
Safety:
The patient’s suitability for therapy with the OMEGO® Basic is to be assessed by the
treating physician or therapist.
The suggested therapy duration is approx. 30-60 min/day but the actually permissible
duration is highly dependent on each patient’s general condition and capacity and thus
has to be assessed individually.
Prior to therapy the treating physician or therapist has to assess if and how long the
patient can manage independently, taking into consideration the patient’s cognitive
capacities as well as the general condition.
Deterioration of postural stability: Patients suffering from impaired balance while sitting
have to be monitored and supported throughout the therapy.
The device and its control elements (software) may only be operated by trained
therapists. Make sure the patient does not change any settings during therapy.
If the therapist is leaving the patient’s range of vision and/or is out of earshot, the therapy
has to be paused.
Patients with limited cognitive capabilities have to be monitored at all times.
The OMEGO® Basic may not be moved nor may its position be changed during an ongoing
therapy.
Only start the OMEGO® Basic once the patient is secured.
Over-extension of the knees: The range of motion may have been set inaccurately, which
can cause a high mechanic pressure on the knee joint and/or hip. Please always check the
range of motion settings.

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Trying to adjust the device while the cranks are in motion or during therapy poses a
jamming hazard:
While the cranks are spinning or a therapy session is in process, neither the operator nor
any other person may modify the device’s mechanic settings (pedal radius, height
adjustment of handles, foot rest replacement etc.).
Never attempt to modify a moving part!
Limiting the means of escape: The mechanic fixation of the foot shovel to the device may
result in the patient’s delayed departure (e.g. in case of fire alarm). Make sure a trained
person who in the case of a dangerous situation can unfasten the fixation supervises the
patient.
The therapy of children (6 years and older) has to be supervised by a therapist at all times.
The suitability of children over the age of 6 years has to be assessed by the treating
physician or therapist. Due to their body structure and insufficient compliance children
aged 5 years and younger are not suited for therapy with the device.
For a height below 130cm special care has to be taken with regards to the range of
motion.
Application:
Only attachment systems provided by Tyromotion may be used to attach the patient.
Other attachment systems may pose a hazard.
Risk of injury by stuck clothes: The patient has always wear suitable, tight clothes. Wide
pants, long scarves and shawls, long hair etc. may get caught in the pedals. The patient
has not wear necklaces, jewelry or similar. The patient has always wear closed footwear
without laces.
All settings, especially maximum speed, maximum force and maximum range of motion
have to be determined by the treating physician prior to the first therapy session.
During therapy, only trained personnel may be around the patient and therapy system.
Ideally, the therapist is right next to the patient to instruct him/her during therapy.
Patients who cannot sit upright unassisted have to be brought into a position suitable for
therapy and secured by appropriate means.

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Foot fixation:
Fastening the foot fixation too tightly may cause reduced blood supply to legs and feet.
Prior to therapy, make sure the fixation is conveniently fastened and/or ask the patient if
he/she experiences circulatory disorders.
Jamming hazard caused by incorrect fixation of the feet in the foot rests:
Always make sure the patient’s feet are firmly secured in the foot rests.
Application of foot drop therapy:
A special training for operators performing this therapy is compulsory.
Please note that a separate mechanic foot attachment with magnetic coupling is
available for this application. This will restrict the maximum force and thus allow for a
quick release from the foot rest in case of an emergency.
Cleaning the OMEGO® Basic System and accessory parts:
Transmission of germs between patients:
Always adhere to the cleaning instructions as stated in this manual.
Compulsory disinfection measure:
Disinfect handles after therapy.
1.1.9 Owner’s responsibility
The owner is responsible for ensuring that all persons who operate the system have read
and understood this user manual. However, we cannot guarantee that every person who
has read this manual is qualified to operate, inspect, check, calibrate, repair or modify
the system or fix system errors. The owner must ensure that the installation,
maintenance, calibration and repair of the system as well as the fixing of errors are only
performed by properly trained and fully qualified personnel. The owner of the OMEGO®
Basic system must ensure that only properly trained and fully qualified personnel
(certified users or operators) receive the authorization to operate the system. It must be
ensured that the user has read and fully understood the operating instructions contained
in this user manual and has been trained either by TYROMOTION or by other employees
of the owner who have been trained by TYROMOTION before being authorized to
operate the PABLO® system. The owner is obligated to maintain a list of authorized
operators. The operator must contact TYROMOTION if the system does not work
properly or does not respond correctly to the commands described in this user manual.

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1.1.10 Error and omissions
Please contact TYROMOTION GmbH if this user manual contains errors or omissions
(addresses are listed at the beginning of the document and on our website
www.tyromotion.com).
1.1.11 Property of TYROMOTION GmbH
TYROMOTION GmbH owns the copyright-protected content of this user manual,
including all figures and illustrations; this information is exclusively provided for
operational and maintenance purposes. Any distribution for other purposes or copying
without prior written approval by TYROMOTION is prohibited.
1.1.12 Warranty and legal disclaimer
TYROMOTION GmbH issues a warranty to the original system purchaser that the system
shall be free of material and qualitative processing defects for a period of 12 months
under normal usage conditions from the date of installation on the owner's premises and
that the system complies with the mechanical and electrical specifications published by
TYROMOTION (unless the warranty term is extended by an optional service contract).
This warranty is granted under the provision that the system is installed, operated and
maintained in accordance with the user manual. The customer must submit all warranty
claims to TYROMOTION in written form within 60 days of the occurrence of the problem
and before the expiry of the warranty. TYROMOTION is exclusively obligated to repair,
exchange or correct faulty or non-compliant parts at its own discretion in accordance
with the warranty. TYROMOTION has no further obligations to the owner in regard to
these parts after the repair or exchange of faulty or non-compliant parts. All repairs or
maintenance work must be performed by an authorized TYROMOTION service
representative in accordance with this warranty. The above mentioned warranty
becomes null and void if repairs, maintenance or other work is performed by third
parties. Moreover, problems resulting from accidents, improper use, incorrect
application, storage damage, negligence as well as system or component modifications
are excluded from the warranty.
The above mentioned warranty is granted in place of all other warranties, rights or
conditions, and the system is delivered "without deficiency warranty" apart from the
limited warranty. TYROMOTION and its third-party suppliers specifically and
unreservedly reject all other explicit or implicit warranties held by the owner, his
personnel and patients, customers, users and any third parties, unreservedly including
all warranties for marketability, applicability for a specific purpose, non-infringement and
any warranties resulting from performance development, business trends or commercial
customs. TYROMOTION and its third-party suppliers do not provide declarations or

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warranties for system compliance with the owner's requirements or for functionality
without interruption, errors or deficiencies.
TYROMOTION is in no way liable for indirect, incidental, specific or consequential
damage or for punitive damage compensation including, among other things, the loss or
absence of profits, yield, goodwill or usage, which the owner or third parties may incur
or for damage to connected equipment, costs for replacement products, installations,
servicing, exchange elements or idle time or for claims from patients, customers, visitors,
the owner's employees or other persons, regardless whether submitted within the
context of a contractual claim, due to unauthorized behavior, strict liability or imposed
by law or otherwise even when TYROMOTION has been informed about the possibility
of such damages. TYROMOTION's liability for damages resulting from or in connection
with this contract may not in any event exceed the purchasing price of the system.
Some jurisdictions limit or exclude the extent of restrictions, the exclusion of legal
means, compensation or liability, such as liability for gross negligence or willful
misconduct according to or in the abovementioned extent or do not permit the exclusion
of implicit warranties. In such jurisdictions, the restriction or exclusion of warranties,
legal means, compensations or liabilities described above may not be valid for the owner.
Such restrictions or exclusions apply according to the highest legally permitted extent
even if they are not valid according to the legally prohibited extent. The owner may also
have other rights that vary depending on the specific country or other jurisdictions.
Maintenance works may only be carried out if there are no patients
in the device’s direct vicinity.
1.2 Training concept
The OMEGO® Basic system is a complex technical device. Users of the PABLO® system are
required to complete a training course and read the user manual in order to ensure the
safety of patients, users and the device itself. Merely reading the present manual does
not convey sufficient competence for operating OMEGO® Basic. Prospective users are
also required to have basic medical training (e.g. physiotherapy/occupational therapy).
TYROMOTION GmbH rejects all liability for damages resulting from therapy that was
performed by an untrained user. Prospective users are trained after delivery of the
OMEGO® Basic system.
Users are able to perform initial and repeated therapies training with the OMEGO® Basic
system. Users are not permitted to instruct other persons in the usage of the OMEGO®
Basic system. Users are trained by a member of TYROMOTION GmbH or by another
trainer delegated by TYROMOTION GmbH.

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Training content:
•OMEGO® Basic System/component overview
•Functionality and application
•Indications
•Definite contraindications
•Relative contraindications
•Starting the OMEGO® Basic System
•Starting the TyroS software
•Patient selection/creation of a patient file
•Height adjustment of monitor handle bracket
oHeight adjustable parts warning
•Adjustment of pedal radius
oPedal warning
•Adjustment of ALL-IN-ONE PC
•Wheelchair positioning
oWheelchair warning
•Using/loosing of chair safety catch
oChair warning
•Patient attachment
oPatient attachment warning
•Pedal replacement and foot drop therapy application
•Therapy selection
•Steering type
•Adjustment of starting position and steering range
•Therapy games
•Movement therapies
oStepper
oLeg press
oFoot drop
oSensor therapy
oCycling
•Application with kids
•Report evaluation
•Cleaning of device
•General warnings
•Clinical use warnings

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1.3 Symbols on OMEGO® Basic
Emergency stop switch for interrupting the power supply of the drives
Do not discard with household waste.
Application part, type B
Alternating current
CE mark with the number for the notified body
Information about the manufacturer of OMEGO®Basic, including the full mailing
address, is displayed next to the factory symbol.
Follow the user manual: To be read thoroughly prior to activation.
Warning symbol: Crushing hazard warning.
General warning for accessory port:
Only accessories specifically labeled by Tyromotion may be connected. Do not
connect any other devices or accessories.

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IP20
Protection class against foreign objects and water:
2 means protection against penetration of solid objects with a diameter ≥ 12,5
mm. 0 means no protection against ingress of water.
Labelling on the power switch:
I means the device is activated.
O means the device is deactivated.
When the power switch is pressed, the entire device is switched to live / de-
energized.
Do not touch
This symbol indicates that it is prohibited to touch the device’s moving foot rests
as this may pose an increased risk for operator and patient.
No entry
Entering the area is prohibited due to pinch point hazard.
Children aged 0 to 5 years are prohibited
Children under 6 are exempt from use due to inadequate compliance and physical
structures.
Table 2
1.3.1 Type label
Image 2: OMEGO® label
The type label designates OMEGO® Basic as a medical product.

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Technology
2.1 Technology
2.1.1 Overview
Type description:
OMEGO® Basic
Build year:
Can also be determined from the serial number, e.g. SN: OR1-2017-XXX refers
to the year 2017.
Classification:
According to rule 9 of the commission guideline 93/42/EWG, appendix IX, the
OMEGO® System is an active therapeutical Medical Device Class IIa.
Type of applied part:
Type B
Protection against electric
shock:
Protection class I device –protective grounding
Electromagnetic
compatibility:
Class B device (CISPR 11) The OMEGO® Basic System may only be used in the
living area under the responsibility of a health care professional. EN60601-1-2:
2001, the requirements are fulfilled.
Country of origin:
AUSTRIA
Power supply voltage:
110 –240V alternating current
Supply frequency:
50/60Hz
Electricity/Power
consumption:
16A –7 A/1800W-1700W
Supply grid:
Only connect to supply grids with protective ground wiring.
Operating type:
Continuous operation
Fuses:
Secured for all poles (2x T16A L 250V)
Power supply drives:
48V DC
Maximum velocity:
80 U/min
Nominal drive performance:
800 Watt / drive
Maximum torque:
65 Nm unilateral/ 50 Nm bilateral
Measurement range torque
measurement:
±70Nm
Measurement error torque
measurement:
< 10%