mindmaze Izar User Manual
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mindmaze Izar User Manual

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  • Page 3 Izar ™ User Manual Manuel de l’utilisateur Benutzerhandbuch Manual del usuario Manuale d’uso P108 Manual de utilizare P133 D-2013-LBL-0131-AAD...

  • Page 7: Table Of Contents

    Contents 1. Safety Information 2. Before use 3. Product description 4. Setup 4.1. Unpacking 4.2. Device setup 4.3. Connection with MindMotion™ Go 4.4. Troubleshooting 5. How to use 5.1. LED indications 5.2. Charge 5.3. Reset internal pressure 5.4. Cleaning 5.5. Maintenance 5.6.

  • Page 8: Safety Information

    1. Safety Information 1.1 Warnings and precautions Symbol Meaning A WARNING statement provides important information about a potentially hazardous situation that, if not avoided, could result in serious injury or death A CAUTION statement provides important information about a potentially hazardous situation that, if not avoided, may result in minor or moderate injury to the user or patient or damage to any equipment connected Manufacturer name and address...
  • Page 9 Device article number Serial number WEEE Compliance Logo: the electronic device will not be disposed of through common waste means, and follow local regulations regarding electronic devices recycling Protect from water: advise the operator to protect the device from water and keep it away from rain Keep away from direct sunlight: advise the operator to protect the device from direct sunlight Indoor use only...
  • Page 10 Electrical safety Class I Izar™ is a Type BF (Body Floating) applied part Not made with natural latex rubber Alternating current input on AC power supply Direct current output from power supply Protection class II equipment: The AC Power Supply device has double insulation.
  • Page 11 An explosion hazard may result from the use of flammable anesthetics, oxygen-rich environments, skin cleansing agents and disinfectants • Do not overheat Izar™. Do not place it close to a fireplace or a radiant heater • Do not expose Izar™ to moisture coming for example from nebuliser or steam kettle •...
  • Page 12 • Strangulation: do not wrap the adapter cable around your neck • Do not apply a force of more than 80 kg on Izar™, as this could damage the device and generate fire or explosion of the battery • Inspect Izar™ and its accessories before using it. Never use Izar™ or any...
  • Page 13 Wash and disinfect Izar™ between the usage with different patients • Do not use Izar™ if a patient has a skin infection or skin injury at the hands • Parts of Izar™ that come into contact with the patient when used as intended, are designed to fulfil the biocompatibility requirements of the applicable standards.

  • Page 14: Before Use

    1.2 Serious Incident Any serious incident occurring in relation to Izar™ should be reported to the manufacturer and the competent authority of the member state in which the user and/or the patient is established. Any unexpected operation shall be reported to the manufacturer.

  • Page 15: Product Description

    2.3 Contraindications Please refer to Safety information. 3. Product description Izar™ is a medical device to support hand and wrist rehabilitation. 4. Setup If you encounter any difficulties during installation, contact MindMaze customer support at customersupport@mindmaze.com English...

  • Page 16: Unpacking

    4.1 Unpacking H1. Izar™ with wrist strap H2. Izar™ Docking Station H3. Bluetooth Dongle H4. Izar™ Power adapter with UK, US and EU plugs H5. Izar™ wrist strap installation tool English 10/157...

  • Page 17: Device Setup

    4.2 Device setup Power Adapter Insert the plug corresponding to your country E-2013-PWR2-ACDC E-2013-PWR1-ACDC In case you need to change the connector type E-2013-PWR2-ACDC E-2013-PWR1-ACDC English 11/157...
  • Page 18 Place Izar™ on the docking station. Never place any foreign object, especially metallic, on the docking station as this will prevent Izar™ from being properly charged Insert the Bluetooth dongle into a USB port of the computer. Ensure to...
  • Page 19 3 m from it. Wrist strap There is a wrist strap attached to Izar™. This is to attach Izar™ to the patient’s wrist and to prevent Izar™ from falling accidentally during the therapy. In case you don’t want to use the wrist strap you can remove with the following steps:...

  • Page 20: Connection With Mindmotion™ Go

    4.3 Connection with MindMotion™ Go To connect a new Izar™ to a MindMotion™ GO, click on icon in the top right corner and then on “Izar” in the left menu. Place Izar™ on the docking station and click on the Prepare button. 4.4 Troubleshooting Izar™...
  • Page 21 Izar™ is not charging If Izar™ does not charge or is not charged after more than 3 hours of charge, there is the possibility that the temperature is too high. If the docking station is in a warm environment, try to put it in a cooler environment.

  • Page 22: How To Use

    5. How to use Izar™ doesn’t have a power switch, it automatically switches on when it is moved by the user. If not moved for one minute, it automatically goes into standby. During a session or while on the docking station, Izar™ is constantly on.
  • Page 23 Solid green when the ball is fully charged • Off when Izar™ is not on the docking station, if the docking station is not properly connected to the main or in case of errors Izar™ is equipped with an LED that will be: •...

  • Page 24: Charge

    Izar™ which might make Izar™ softer than usual. In this case, the button can be used to let air into Izar™, so that Izar™ regains its initial rigidity. Press the button and hold for a few seconds until Izar™ is fully reinflated.

  • Page 25: Maintenance

    • Applied part: Type BF (Izar™) • Power adapter: only power adapter provided by MindMaze and with P/N E-2013-PWRx-ACDC-xxx (MMIZ-Px with the box) can be used to recharge the battery of Izar™ with the docking station •...

  • Page 26: Storage And Transport Conditions

    Passed this duration, you can continue using Izar™ as long as it is working correctly and it does not present a default. Do not store Izar™ for an extended period of time (over 6 months) without recharging it regularly (every 3 months), as this could damage the battery.

  • Page 27: Spare Parts / Repairs

    MMIZ-W1-R Wrist Strap Do not try to repair or to replace any part of the device as this could result in a risk of fire or explosion. Contact MindMaze customer support for more information. 5.11 EMI Emissions System characteristic Description Frequency (MHz) 2,400 –...

  • Page 28: Guidance And Manufacturer's Declaration - Electromagnetic Compatibility

    Izar is intended for use in the electromagnetic environments specified in this document. Izar has been tested and found to be in compliance as shown. You should take care to use the device as described. 5.12.1 Electromagnetic Emissions...
  • Page 29 5.12.2 Electromagnetic Immunity IEC 60601 Compliance Immunity test Guidance test level level Electrostatic ± 8kV contact ± 8kV contact Floors should be wood, discharge (ESD) ± 2, ±4, ±8, ± 2, ±4, ±8, concrete or ceramic tile. ±15kV air ±15kV air If floors are covered with synthetic material, the relative humidity should be...
  • Page 30 3 Vrms 3 Vrms If the measured field IEC 61000-4-6 150 kHz to 80 150 kHz to 80 strength in the location in which the Izar system Radiated RF IEC 61000-4-3 6 Vrms 6 Vrms is used exceeds the ISM Bands...
  • Page 31 80 MHz to 2,7 80 MHz to 2,7 communications immunity IEC 61000-4-3 equipment should be used no closer to any part of the Izar system, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter.Recommended...
  • Page 32 RF compliance level above, the Izar device should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocation of the Izar device.
  • Page 33 5.12.3 Guidance Portable and mobile RF communications equipment should be used no closer to any part of the devices, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Recommended separation distance (d): where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in metres (m).

  • Page 34: Fcc Compliance Information

    According to the transmitter manufacturer The ISM (industrial, scientific and medical) bands between 150 kHz and 80 MHz are 6.765-6.795 MHz, 13.553-13.567 MHz, 26.957-27.283 MHz and 40.66-40.7 MHz Formulas coming from the IEC 60601-1-2 Interference may occur in the vicinity of equipment marked with the following symbol: Note: These guidelines may not apply in all situations.

  • Page 35: Ic Compliance Information

    following measures: • Reorient or relocate the receiving antenna • Increase the separation between the equipment and receiver • Connect the equipment into an outlet on a circuit different from that to which the receiver is connected • Consult the dealer or an experienced radio/TV technician for help 6.2 FCC human exposure limits This device complies with FCC radiation exposure limits set forth for general population.

  • Page 36: Rf Exposure Compliance - Europe

    This device contains licence-exempt transmitter(s)/receiver(s) that comply with Innovation, Science and Economic Development Canada’s licence-exempt RSS(s). Operation is subject to the following two conditions: • This device may not cause interference • This device must accept any interference, including interference that may cause undesired operation of the device 7.2 IC human exposure limits This device complies with ISED radiation exposure limits set forth for the general...

  • Page 37: Disposal

    REQUIREMENTS. 10. Disposal At the end of their lifetime, Izar™ and its accessories shall be disposed of in conformity with the regulation of your country regarding electronic equipment. Particular attention shall be paid to Izar™ as it contains a lithium battery. Do not dispose of Izar™...
  • Page 38 Or visit our website for additional contact GENIOUS Healthcare SAS information: 26 rue Cambaceres https://www.mindmaze.com/contact/ 75008 Paris, France All Images noncontractual Copyright© MindMaze Group SA 2022. All rights reserved. Device Model: MMIZ-S1 FCC ID: 2AYHHMMIZ-S1 IC ID: 26802-MMIZS1 English 32/157...

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