Tyromotion OMEGO Basic Manual
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Tyromotion OMEGO Basic Manual

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

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  • Page 1 ® OMEGO Basic GEBRAUCHSANWEISUNG / MANUAL Sprachen / Languages: Deutsch (DE), English (EN) Ausgabedatum der Gebrauchsanweisung: 02 Juli 2018 / Issuing Date of User Manual 2 July 2018...
  • Page 2 Contact information: Manufacturer: TYROMOTION GmbH Bahnhofgürtel 59 8020 Graz AUSTRIA +43 316 908 909 +43 316 231123 9144 MAIL office@tyromotion.com www.tyromotion.com SUPPORT support@tyromotion.com Distributor (Belgium): Distributor (Germany, Switzerland): Arseus Medical TYROMOTION GmbH Rijksweg 10 Bahnhofgürtel 59 2880 Bornem 8020 Graz...

  • Page 3: Table Of Contents

    Intended purpose 1.1.6 Notices 1.1.7 Safety 1.1.8 Warnings 1.1.9 Owner’s responsibility 1.1.10 Error and omissions 1.1.11 Property of TYROMOTION GmbH 1.1.12 Warranty and legal disclaimer Training concept Symbols on OMEGO® Basic 1.3.1 Type label Technology Technology 2.1.1 Overview 2.1.2 Usage area ®...
  • Page 4 Securing feet with Velcro ® straps 4.4.3 OMEGO Basic® Applications 4.4.4 Foot drop therapy applications After application 4.5.1 Turning off the OMEGO Basic® System 4.5.2 Cleaning the OMEGO Basic®-Systems and accessory parts 4.5.2.1 Detergents and disinfectants 4.5.2.2 water 4.5.2.3 instruments 4.5.3 cleaning process...

  • Page 5: Introduction

    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®...

  • Page 6: System Content

    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 1x set for normal Therapy (item number O.G200 and O.G201) ▪ 2x wide Velcro straps for foot fixation ▪...

  • Page 7: Intended Purpose

    ® 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®...

  • Page 8: Notices

    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.
  • Page 9 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.
  • Page 10 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:...
  • Page 11 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. EN – 11...
  • Page 12 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.
  • Page 13 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.

  • Page 14: Owner's Responsibility

    TYROMOTION or by other employees of the owner who have been trained by TYROMOTION before being authorized to operate the PABLO®...

  • Page 15: Error And Omissions

    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.

  • Page 16: Training Concept

    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. EN – 16...
  • Page 17 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 Height adjustable parts warning •...

  • Page 18: Symbols On Omego® Basic

    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. EN – 18...

  • Page 19: Type Label

    Protection class against foreign objects and water: IP20 ≥ 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.

  • Page 20: Technology

    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®...
  • Page 21 Weight: 75kg Dimension (WxLxH) in mm: 1017 x 825 x 1225 Penetration protection: IP 20 Table 3: Technical data OMEGO Basic is classified as a medical electronic device and therefore ® subject to specific precautionary measures relating to electromagnetic compatibility (EMC). It is absolutely imperative to observe the stated EMC indications.
  • Page 22 Guidelines and MANUFACTURER‘s declaration – ELECTROMAGNETIC IMMUNITY The OMEGO® Basic system is designed for operation in an ELECTROMAGNETIC ENVIRONMENT as indicated below. The customer or user of the OMEGO® Basic system must ensure that it is used in such an environment.
  • Page 23 Table 5: Guidelines and Manufacturers‘s declaration – Electromagnetic Immunity Guidance and Manufacturer’s Declaration— ELECTROMAGNETIC IMMUNITY The OMEGO® Basic system is designed for operation in an ELECTROMAGNETIC ENVIRONMENT as indicated below. The customer or user of the OMEGO® Basic system must ensure that it is used in such an environment.
  • Page 24 NOTES: - At 80 MHz and 800 MHz, the higher frequency range applies. - These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects, and people. Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy.

  • Page 25: Usage Area

    0,37 0,11 0,22 0,35 For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer.
  • Page 26 Internet connection from the PC. The port at the front of the device may only be used to connect accessories specifically labeled by Tyromotion. Do not connect any other devices or accessories. EN – 26...

  • Page 27: The Omego Basic System

    ® 2.2 The OMEGO Basic System ® Image 3: Symbolic image OMEGO Basic (front side) ® Image 4: Symbolic image OMEGO Basic (rear side) EN – 27...
  • Page 28 All-In-One PC with tilt adjustment joint Handles Emergency stop button Pedal radius adjustment mechanism Transportation handle Accessory port Foot rest Self-operable tip-up protection Front standing unit with adjusting feet Rear standing unit with transport castors Power switch Power supply Drive unit Adjustment joint with catch bolt for monitor bracket Monitor arm bracket ®...

  • Page 29: Power Supply Omego ® Basic

    The system will be unpacked and installed by authorized service representatives of TYROMOTION GmbH (details can be found in chapter 2.5). Do not try to install the system alone. 2.2.3 Repair Please contact always the manufacturer for repairs! 2.2.4 Disposal –...

  • Page 30: Omego Basic Adjustment Options

    ® 2.3 OMEGO Basic adjustment options 2.3.1 Height adjustment of the monitor handle bracket You have the option to adjust the bracket of the OMEGO Basic’s monitor handle to the ® patient’s height. Hold the PC handle (1) or the monitor handle bracket (2), pull out the catch bolt (3) and keep it in position.

  • Page 31: Pedal Radius Adjustment

    Monitor handle jamming risk Adjust the position of the monitor handle bracket with care and never grasp the bracket’s locking mechanism. 2.3.2 Pedal radius adjustment You have the option to adjust the OMEGO Basic’s pedal radius to the patient’s needs ®...

  • Page 32: Foot Rest Replacement

    2.3.3 Foot rest replacement • Loosen the screw on the foot shell with the provided hexagon screwdriver. • For the replacement of the foot rest pull out the catch bolt and, on the rail, pull out the foot rest (1). •...
  • Page 33 Image 9: Left foot rest – article number Image 10: Right foot rest – article O.G201 number O.G200 Foot rest set – foot drop therapy Image 11: Left foot rest – article number Image 12: Right foot rest – article O.G251 number O.G250 EN –...

  • Page 34: All-In-One Pc Adjustment

    Image 13: Foot fixation with magnetic coupling 2.3.4 ALL-IN-ONE PC adjustment When adjusting the height of the handles (see chapter 2.3.1.) the PC height will be modified automatically. Additionally, you can adjust the tilting angle of the tilting joint (1) on the PC’s VESA bracket. To do so you only have to hold the monitor on the side and tilt it until it has reached the desired position.

  • Page 35: Wheelchair Positioning

    2.4 Wheelchair positioning When using the OMEGO Basic with a wheelchair, position the wheelchair as close to the ® device as possible. Always start with the shortest possible distance between the wheelchair and the OMEGO Basic. Increase the distance with the progression of the ®...
  • Page 36 Image 1-4 Image 2-4 Image 3-4 Image 4-4 Image 16: Attaching the safety catch EN – 36...
  • Page 37 Unfasten the safety catch as follows (see Image 17): 
 • Push down belt dispenser lever.
 • Pull up hook and unclasp it from the chair/wheelchair frame. • Allow belt to fully retract. Image 17: Unfastening of 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.

  • Page 38: Device Setup And Movement

    2.5 Device setup and movement When installing the device, make sure that the device is placed on an even, non-slanted surface. If necessary, place the device against a wall. The device must be placed at least 30 cm away from other devices, furniture, etc., to ensure optimum ventilation for the drive units.

  • Page 39: Monthly Functionality Check/Recurring Check

    • Do not perform any further Casings are missing • Protective casing therapies Mounting bolts are missing or • loose Contact TYROMOTION GmbH • Casings are damaged • • Parts are deformed Do not perform any further Visible external •...

  • Page 40: Recurring Check

    The device operator is responsible for performing both checks. TYROMOTION GmbH has determined an interval of one year for recurring checks. Recurring checks may only be carried out by professional and qualified personnel. The device operator must ensure that the intervals for the recurring checks stipulated by him are observed.

  • Page 41: Preparation / Basics

    ® only be carried out once the device has been set up at its final destination. The system will be unpacked and installed by specially trained TYROMOTION GmbH staff. The following steps have to be executed prior to the OMEGO Basic’s initial operation:...
  • Page 42 Mounting the All-IN-ONE PC on the monitor arm The All-IN-ONE PC comes fixed to a VESA-bracket and needs to be mounted on the monitor arm. Secure the All-IN-ONE PC with a screw on the monitor arm. Image 23: Place the All-IN-ONE PC on the Image 24: Secure the All-IN-ONE PC bracket with a screw on the monitor arm...
  • Page 43 Image 27: Connect power cable Image 28: Connect USB cable Image 29: Position of the connections Mounting the foot rests As a final step, mount the foot rests. Choose the desired foot rests, pull out the catch bolt and on the slides, push the foot rests into position. Let go of the catch bolt as soon as you have found the desired position and it will automatically lock in place.

  • Page 44: Clinical Application

    Please contact TYROMOTION GmbH in case of any questions or feedback. (Addresses are listed at the beginning of this document as well as on our homepage www.tyromotion.com).
  • Page 45 • Amputation • Edema Absolute contraindications: To not use the device! • Acute, pronounced pain despite conventional pain therapy • Adjustability and patient position: Do not use the OMEGO Basic System for ® training if it is impossible to adjust the device and the individual physiological patient position, especially in case of contractures or severe spasticity (stiff/rigid joints) of the lower body region.
  • Page 46 • Cardiac diseases, e.g. heart failure and thoracotomy, uncontrolled orthostatic hypotension or other circulatory problems, circulatory disorders of the lower limbs • Recent joint operations, e.g. total endoprosthesis, knee- or hip joint replacement, reconstruction of the cruciate ligament or meniscus •...

  • Page 47: Safety

    4.2 Safety 4.2.1 Safety concept The OMEGO Basic is a mechatronic therapy system used for the rehabilitation of all gait- ® relevant bodily functions. The 2 separate motors are centrally controlled by the software installed on the PC. In order to preclude the exertion of strong forces during therapy (e.g. in case of sudden spasticity) or too big a range of motion on the patient several safety measures have been put in place: •...
  • Page 48 Deterioration of postural stability: Patients suffering from an 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.

  • Page 49: Residual Risk

    In rare cases, the patient may experience minor pinching or crushing injuries even during proper operation. However, the probability of such injuries is very low, and the injuries should not be severe. TYROMOTION GmbH can provide a detailed risk analysis upon request.

  • Page 50: Prior To Training

    Once this is completed, the foot rests lock into the easy entry position and the feet can be secured in the foot rests. Only attachment systems provided by Tyromotion may be used to attach the patient. Other attachment systems may pose a hazard.

  • Page 51: Patient Information

    System and an encrypted version is stored in tyroS. Furthermore, type, duration and results are recorded to be used for a targeted evaluation. This data will not be passed on to Tyromotion GmbH but will remain with the device operator. Country-specific data protection laws are to be observed! 4.4.2 Securing the feet...
  • Page 52 Image 31: Securing the foot with the Velcro ® strap 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.

  • Page 53: Omego Basic® Applications

    4.4.3 OMEGO Basic® Applications After securing the feet you can choose from the following applications in the tyroS software: • Cycling The patient performs a circular movement against a defined drag. The aim is for the patient to keep up the step frequency specified by the therapist.

  • Page 54: Foot Drop Therapy Applications

    You can find more detailed information regarding the application of the various programs in the tyroS software manual. Depending on mode the patient can be involved passively, assistively or actively. An integrated sensor technology facilitates the capture and evaluation of the leg forces ®...

  • Page 55: After Application

    Release the foot fixation after you have finished the application and move the chair/wheelchair away from the device. Always pay attention to the patient’s postural stability. 4.5.1 Turning off the OMEGO Basic® System Before you can turn of the OMEGO Basic System you have to exit the operating system, ®...

  • Page 56: Cleaning The Omego Basic®-Systems And Accessory Parts

    Cleaning must be carried out in a manner that minimizes the risks posed by pathogens. The devices of the Tyromotion GmbH must be cleaned and disinfected after delivery before the first and any further use on the patient.

  • Page 57: Cleaning Process

    4.5.3 cleaning process To minimize the risk of germ transmission, all surfaces and objects that are touched by both the patient and the therapist should be periodically cleaned and disinfected. These include e.g. also monitor, foot shells, bracket monitor handle, housing, etc. If the patient perspires heavily during use, wipe the OMEGO®...
  • Page 58 TYROMOTION GMBH TYROMOTION GMBH Bahnhofgürtel 59 Bahnhofgürtel 59 8020 Graz, Austria 8020 Graz, Austria +43 316 908 909 +43 316 908 909 +43 316 231123 9144 +43 316 231123 9144 MAIL MAIL office@tyromotion.com office@tyromotion.com www.tyromotion.com www.tyromotion.com SUPPORT SUPPORT support@tyromotion.com support@tyromotion.com...

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