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

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Instructions For Use
For Qualified Personnel
Version 3.0 / 2023.07.14

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Summary of Contents for Aether Biomedical Zeus

  • Page 1 Instructions For Use For Qualified Personnel Version 3.0 / 2023.07.14...
  • Page 2 Instructions For Use Aether Biomedical ZEUS INTENDED USE PATIENT POPULATION SAFE USAGE TECHNICAL SPECIFICATION SCOPE OF DELIVERY. ZEUS GRIPS Opposed Grips Non-opposed Grips Moving the thumb Changing grips INTERFACE WEB APPLICATION CONTROL METHOD WARRANTY AND COMPATIBILITY Compatibility Warranty U01DC-0301 IFU-EN...
  • Page 3 Aether Biomedical Instructions For Use Cleaning Maintenance SAFETY AND WARNINGS Hand Troubleshooting Regulatory Compliance SYMBOLS EMC LABELLING INFORMATION 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.

  • Page 4: Intended Use

    Instructions For Use Aether Biomedical Zeus Zeus ( Zeus v1 Artificial Bionic Prosthetic hand; Zeus The Bionic Hand) is a multi-articulating myoelectric hand 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 individu- ally, allowing them to conform to the shape of the object, regardless of shape or size.

  • Page 5: Patient Population

    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.

  • Page 6: Technical Specification

    Instructions For Use Aether Biomedical Technical Specification Height (finger tip to wrist base) 172mm / 6.77in Palm Width 86mm / 3.38in Thickness 30.5mm / 1.20in 350N Force with closed hand (static, carrying a bag) 78.68lbf Device weight with QWD 590 g/ 1.3lbs...

  • Page 7: Operating Range

    Aether Biomedical Instructions For Use Operating Range Storage Range (at home – between uses) Temperature: Pressure: Temperature: Humidity: -5°C to +45°C 700 hPa to 1060 hPa -25°C to +70°C Up to 93% Humidity: 15% to 93% RH (non-condensing) Key Features...

  • Page 8: Scope Of Delivery

    Product A-01-L-T Zeus hand - Left A-01-R-T Zeus hand - Right 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.
  • Page 9 Aether Biomedical Instructions For Use Opposed Grips Power Grip In this grip, the thumb is opposed, while all of the fingers 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 fingers and thumb.
  • Page 10 Instructions For Use Aether Biomedical Precision Open In this grip, the thumb moves Grip mid-point and stops. The index finger can be controlled proportional- ly to form a pinch. Middle, ring and little fingers remain open. This grip can be used for picking up small delicate objects and various precise activities.
  • Page 11 Aether Biomedical Instructions For Use Tripod Closed The grip a l l o w s Grip hold medium sized objects such as a pen, car keys and eggs. The thumb assumes a midpoint position while the index and middle finger move proportionally to reach the tip of the thumb.
  • Page 12 Instructions For Use Aether Biomedical Non-Opposed Grips Finger T he index finger is active and in a pointing Point position with the rest of the fingers closed. This can be used for pushing switches and buttons. Active The index finger is active and in a pointing position with the rest of the fingers open.
  • Page 13 Because self-locking nature Zeus, the fingers 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. U01DC-0301 IFU-EN...
  • Page 14 Instructions For Use Aether Biomedical This is a commonly used grip for picking up thin flat objects, holding a key or turning a page. The four fingers Grip assume a position to provide a flat platform for the thumb. The thumb can be controlled proportionately to open and close.
  • Page 15 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. Non-opposed Opposed ▶...

  • Page 16: Changing Grips

    Instructions For Use Aether Biomedical 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;...
  • Page 17 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: U01DC-0301 IFU-EN...
  • Page 18 Clinicians are granted access to the web Zeus configuration application. The software is designed for prosthetists to make change in the Zeus setting to fine-tune functions for users. The Interface software is designed for use only by qualified and Zeus certified prosthetists.

  • Page 19: Control Methods

    Aether Biomedical Instructions For Use Control Methods The three types of possible signals detected by sensors include: Open-contraction of extensor muscles. Close-contraction of flexor muscles. Co-contraction - Contraction of both flexor and extensor muscles simulta- neously. It can be compared to making...
  • Page 20 Instructions For Use Aether Biomedical 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: ○...

  • Page 21: Warranty

    Please refer to the compatibility manual DMR-4 v 1.1. Warranty The Zeus hand comes with a 2-year-standard warranty from Aether Biomedical Sp. z o.o. In addition, extended warranty packages are available. The Zeus hand must be serviced every 12 months.

  • Page 22: Maintenance

    Instructions For Use Aether Biomedical ○ The warranty includes - ● Free of charge repair* of the prosthesis hand ● Free of charge replacement unit for the period of repair and maintenance in case of warranty * Superficial damage and damage resulting from negligence or improper use are not included.

  • Page 23: 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 24: Troubleshooting

    Instructions For Use Aether Biomedical ○ Ensure that no body parts are between the fingertips when closing the hand. ○ When closing the hand, ensure that fingers and other body parts are not in the area of the finger joints.

  • Page 25: Regulatory Compliance

    Aether Biomedical Instructions For Use ○ Fingers are moving erratically: ● We recommend removing the EMG electrodes, cleaning with an alcohol wipe and reattaching to Zeus. ○ Water splashes into Zeus: ● Immediately disconnect and remove the battery. ● Try to dry off any visible water.
  • Page 26 Protect from water 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. Serial Number Indicates the model number of the product. Unique Device Identification Indicates a carrier that contains unique device identifier information.
  • Page 27 Aether Biomedical Instructions For Use 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. Model Number Indicates the model number or type number of a product.

  • Page 28: Electromagnetic Compatibility

    The Zeus hand complies with the requirements of the standard IEC 60601-1-2: Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests.
  • Page 29 Otherwise, degradation of the performance of this equipment could result. Warning! Fitting a patient with Zeus may only be carried out by a prosthetist who has been authorized by Aether Biomedical after completion of a corresponding training course.
  • Page 30 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 31 Aether Biomedical Instructions For Use Table 2 - Test levels for Proximity fields from RF wireless communications Test Frequency Immunity Compliance Band Service Modulation Test Level V/m Test level V/m Pulse Modulation 380 - 390 TETRA 400 18Hz FM ± 5kHz deviation 430 –...
  • Page 32 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 33 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 34 Aether Biomedical Instructions For Use AETHER www.aetherbiomedical.com Aether Biomedical Sp. z o.o. ul. Mostowa 11, 61-854 Poznań POLAND 2-B 75, Lajpat Nagar 2, New Delhi-110024 INDIA 874 Walker Road, Suite C Dover, Delaware 19904 Aether US Inc phone: POLAND +48 515 856 103...

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