Aether Biomedical Zeus Instructions For Use Manual
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Aether Biomedical Zeus Instructions For Use Manual

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THE POWER IN YOUR HAND
Instruction
for Use
For Qualified Personnel
Version 1.0

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  • Page 1 THE POWER IN YOUR HAND Instruction for Use For Qualified Personnel Version 1.0...

  • Page 2: Table Of Contents

    Zeus Brochure Aether Biomedical Table of Contents INTRODUCTION....................4 Aether Biomedical..................4 Zeus.........................4 INTENDED USE.....................5 SCHEME OF ZEUS WITH DIMENSIONS..........7 BOX CHECKLIST....................9 ZEUS GRIPS....................9 Opposed Grips....................10 Non-opposed Grips..................13 Moving the thumb..................16 Changing grips.....................17 THE FIRST USE OF THE HAND.............19 Power Switch Button................19 Charging the battery................20...
  • Page 3 Aether Biomedical Zeus Brochure Maintenance....................26 SAFETY AND WARNINGS..............27 Hand........................27 Battery.......................28 TECHNICAL INFORMATIONS..............30 Electrodes......................30 Batteries......................31 Power Button.....................32 ADDITIONAL INFORMATIONS............32 Warranty......................32 Other information...................33 Troubleshooting..................34 Regulatory Compliance..............35 SYMBOLS.....................36 EMC LABELLING INFORMATION............38 Date of the last update of this Instruction for user: 01-06-2020 We highly recommend reading this document carefully before »...

  • Page 4: Introduction

    Zeus Zeus is a multi action bionic limb combining ease of control with an elegant, robust design. The fingers and thumb provide a firm grasp to perform everyday tasks with ease. The fingers stall individually, allowing them to conform to the shape of the object, regardless of shape or size.

  • Page 5: Intended Use

    People with serious mental disorders » Zeus is an external prosthetic hand intended to be used with other appropriate upper limb components to form a complete arm prosthesis, to be fitted only by qualified and certified clinicians. It should be used only by upper limb amputees and by people with congenital absence of an upper limb (forearm).
  • Page 6 Zeus Brochure Aether Biomedical 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.).

  • Page 7: Scheme Of Zeus With Dimensions

    Aether Biomedical Zeus Brochure Technical Specification 560g Device weight 1.5sec Max. closing time 152N 182.7mm Height (finger tip to wrist base) 80.6mm Palm Width 29.9mm Thickness Grip force 7.4V, 2200mAh Flexible battery pack with magnetic charging 500N 350N Force on chassis (static,...
  • Page 8 Zeus Brochure Aether Biomedical Operating Range Storage range (at home – between uses) Temperature: -5°C to +45°C Temperature: Humidity: -25°C to +70°C 15% to 93% RH (non-condensing) Humidity: Pressure: Up to 93% 700 hPa to 1060 hPa Product Features 12 Selectable + 2 User...

  • Page 9: Box Checklist

    Aether Biomedical Zeus Brochure Box Checklist The Zeus V1 is available in both left hand and right hand configurations. Model No. Description Zeus V1 - L Zeus Prosthetic hand - Left Zeus V1 - R Zeus Prosthetic hand - Right The system consists of the following: 1.

  • Page 10: Opposed Grips

    Zeus Brochure Aether Biomedical Opposed Grips Power Grip In this grip, the thumb is opposed, while all of the other four fingers close until they meet the object or receive a closing signal. The strong grip provides 152N of force spread over all four fingers and thumb.
  • Page 11 Aether Biomedical Zeus Brochure Precision Open Grip In this grip, the thumb moves to a mid-point and stops. The index finger can be controlled proportionately to form a pinch. Middle, ring and little fingers remain open. This grip can be...
  • Page 12 Zeus Brochure Aether Biomedical Tripod Closed Grip grip a l l o w s hold medium sized objects. The thumb assumes mid-point position while the index and middle finger move proportionately to reach the tip of the thumb. The ring finger and little finger close fully.

  • Page 13: Non-Opposed Grips

    Aether Biomedical Zeus Brochure Non-Opposed Grips Finger Point This is a static grip, where the index finger remains in a pointing position and the rest of the fingers close. This used for typing, operating mobile phone or pushing switches and buttons.
  • Page 14 Because of the self-locking nature of Zeus, the fingers have a static grip capacity of 35kgs, allowing you to lift heavy objects with ease. This grip can also be used...
  • Page 15 Aether Biomedical Zeus Brochure Mouse Grip This grip is used to operate a computer mouse. The hand assumes the position of the mouse. The index finger and the middle finger can be controlled proportionately to push left and right buttons respectively.

  • Page 16: Moving The Thumb

    Zeus Brochure Aether Biomedical 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. When the thumb reaches the opposed position, you will hear the click.

  • Page 17: Changing Grips

    Aether Biomedical Zeus Brochure Changing grips There are 2 different modes to change grip. The first one is „Individual Mode” in which all grips programmed for » the hand are sequenced in default order. To switch between each grips the user has to make a single co-contraction. This mode is more basic than the other one because there is no option to undo the previous grip.
  • Page 18 Zeus Brochure Aether Biomedical To switch between opposed and non-opposed grips, it is necessary to change the thumb positon accordingly; The grip pairings can be represented as follows: Grip Pairs Opposed 2 x CC Primary Secondary Alternate Default Alternate Default...

  • Page 19: The First Use Of The Hand

    Aether Biomedical Zeus Brochure First Use of the Hand A. Power Switch Button The Power Button is placed on the forearm. You can use 1. To turn the hand ON and OFF - a single long press for approximately three seconds is required. It will switch the hand ON or OFF - depen- ding on its power status.

  • Page 20: Charging The Battery

    Zeus Brochure Aether Biomedical B. Charging the Battery The battery and charge will be in the box if your prosthetist has » ordered them along with the hand The battery life of the prosthesis will vary - it depends on inten- »...
  • Page 21 Aether Biomedical Zeus Brochure Follow these steps to charge the battery 1. Switch OFF your hand by pressing the Power Switch Button for three seconds. Take it off your arm. 2. Plug the supplied power pack into a wall outlet.

  • Page 22: Checking Battery Status

    Zeus Brochure Aether Biomedical 7. To stop charging the batteries, remove the connector and place it on the housing attachment to prevent damage to the connector pins. 8. The battery systems charge fully in approximately 3 hours. 9. Now you can use your prosthesis! C.

  • Page 23: Interface Software

    Interface Software The prosthesis comes with pendrive software for Zeus configuration. The software is designed for prosthetists to make changes in Zeus functions to provide access to all functions for users. The Interface software is designed for use only by qualified and certi- fied.

  • Page 24: Control Methods

    Co-contraction - Contraction of both flexor and extensor muscles simultaneously. It can be compared to making a fist. Zeus utilizes two sensors that detect and amplify raw EMG signals from the user’s skin that come from muscle movements. To create those signals the user has to create a certain muscle activity - a co-contraction.

  • Page 25: Taking Care Of Your Prosthesis

    Patients can choose from the different colors and patterns that are available and customize their hand for perfect aesthetic appearance. Warranty Zeus comes with a 2-year-standard warranty from Aether Biomedical Sp. z o.o. In addition, the following warranty packages are available at the date of purchase: for Battery System - 1 year warranty »...

  • Page 26: Cleaning

    Zeus Brochure Aether Biomedical Please avoid direct exposure to water and situations where dirt and dust are in the closest area as these can interfere with or damage the hands performance. Cleaning The user can remove the dust and dirt with soap and water or alcohol.

  • Page 27: Safety And Warnings

    The user must not submerge the prosthesis in water - it should » be kept away from moisture at all times. Zeus is not water resistant. If any water reaches the internal components of the hand or arm there is a risk of damage and failure. Water damage is not covered by the standard 24 months warranty.

  • Page 28: Battery

    Zeus Brochure Aether Biomedical The product may not be used for handling firearms. » Ensure that no body parts are between the fingertips when using » the product. Ensure that no body parts are between the fingertips when clo- »...
  • Page 29 Move the battery to a safe place and keep a minimum distance » for 30 minutes Do not reuse the battery - it must be disposed » Contact the prosthetist about the situation » Aether Biomedical accepts no responsibility for any damage or inju- ry caused by improper use.

  • Page 30: Technical Informations

    Zeus Brochure Aether Biomedical Technical Information* Electrodes The Element System has three components: IBT Electrodes (up to 2) » Signal Processing Box » Element Desktop Software » Element outputs standard envelope EMG signals detected from the IBT Electrodes placed on the user’s skin. The Element System is an...

  • Page 31: Batteries

    Aether Biomedical Zeus Brochure The signal processing box collects and filters the electrode EMG signals, and outputs envelope EMG signals to the terminal device. The signal processing box contains a Bluetooth module, which allows Element to communicate with the desktop software.

  • Page 32: Power Button

    If any problem with prosthesis occurs please contact your local prosthetist or Aether Biomedical distributor. Making repairs may lead to warranty loss. Zeus comes with a 2-year-standard warranty. There’s also additio- » nal warranty packages available at the day of purchase ▶...

  • Page 33: Other Information

    * Superficial damage and damage resulting from negligence or improper use are not included. The warranty doesn’t include batteries » Zeus needs to be serviced every 6 months. The prosthetist should make sure to provide the next service date to the patient. Untimely service will void the warranty of the product.

  • Page 34: Troubleshooting

    Check if the battery is charged Fingers are moving erratically: » ▶ We recommend cleaning the EMG electrodes with an alcohol wipe, removing and reattaching to Zeus Water splashes into Zeus: » ▶ Immediately disconnect and remove the battery. ▶...

  • Page 35: Regulatory Compliance

    Directive 2007/47/EC. The mark may be applied on packaging, accompanying literature or an enclosure, rather than the product itself. Zeus the bionic hand and its associated components listed in this document are covered by test certificates for: Applicable standards: EN 60601-1 »...

  • Page 36: Symbols

    This symbol indicates the product should be protected from water. Electronic Equipment: Dispose of Properly (WEEE Compliance) Zeus should not be thrown away. with common household waste. Dispose of Element components by either returning the unit to IBT or taking the unit to an official electronics disposal site.
  • Page 37 Aether Biomedical Zeus Brochure On/off button Indicates switches with bi-stable positions. Type BF Applied Part Indicates a type BF (Body Floating) Part complying with IEC 60601-1. Temperature Range This symbol indicates the products temperature range. Serial Number Indicates the serial number that uniquely identifies the device.

  • Page 38: Emc Labelling Information

    The Zeus hand complies with the requirements of the standard IEC 60601-1-2: Medical electrical equipment - Part 1-2: General require- ments for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests.
  • Page 39 Aether Biomedical Zeus Brochure Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in improper operation. If such use is necessary, this equipment and the other equipment sho- uld be observed to verify that they are operating normally.
  • Page 40 Guidance and manufacturer’s declaration – electromagnetic immunity The Zeus Hand is intended for use in the electromagnetic environment specified below. The user of Zeus Hand should make sure that it is used in such an environment. Electromagnetic environment Immunity tests...
  • Page 41 Aether Biomedical Zeus Brochure Table 2 - Test levels for Proximity fields from RF wireless communications Test Frequency Immunity Compliance level Band Service Modulation Test Level V/m level Pulse Modulation 380 - 390 TETRA 400 18Hz FM ± 5kHz deviation 430 –...
  • Page 42 To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the Zeus Hand is used exceeds the applicable RF compliance level above, the Zeus Hand should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the Zeus Hand.
  • Page 43 Guidance and manufacturer’s declaration – electromagnetic immunity The Zeus Hand is intended for use in the electromagnetic environment specified below. The user of Zeus Hand should make sure that it is used in such an environment. The Zeus Hand uses RF energy only for its internal function.
  • Page 44 Zeus Brochure Aether Biomedical www.aetherbiomedical.com ul. Królowej Jadwigi 43, 61-880 Poznań POLAND 72A/ 74, Arjun Nagar, Safdarjung Enclave, New Delhi - 110029 INDIA phone: POLAND +48 515 856 103 INDIA +91 9636842365 e-mail: info@aetherbiomedical.com...

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