2AYHHMMIZ-S1Izar

D-2013-LBL-0131-AAD Izar ™ EN User Manual P1 FR Manuel de l’utilisateur P33 DE Benutzerhandbuch P59 ES Manual del usuario P83 IT Manuale d’uso P108 RO Manual de utilizare P133 1/157English EN Contents 1. Safety Information 2 2. Before use 8 3. Product description 9 4. Setup 9 4.1. Unpacking 10 4.2. Device setup 11 4.3. Connection with MindMotion™ Go 14 4.4. Troubleshooting 14 5. How to use 16 5.1. LED indications 16 5.2. Charge 18 5.3. Reset internal pressure 18 5.4. Cleaning 18 5.5. Maintenance 19 5.6. Technical specifications 19 5 . 7. Storage and transport conditions 20 5.8. Operating conditions 20 5.9. Lifetime of the product 20 5.10. Spare parts / Repairs 21 5.11. EMI Emissions 21 5.12. Guidance and manufacturer’s declaration – electromagnetic compatibility 22 6. FCC compliance information 28 7. IC compliance information 29 8. RF exposure compliance – Europe 30 9. Warranty 30 10. Disposal 31 2/157English EN 1. Safety Information 1.1 Warnings and precautions SymbolMeaning 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 Manufacturing date CE Mark Authorised Representative in the European Community Swiss Made Software Consulting instruction for use Follow the Instructions for Use Wash hands: advise the operator to wash his hands before the use of the system Unique Device Identification 3/157English EN 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 Pressure: accepted pressure transport range within which the transport package shall be stored and handled Temperature: accepted transport temperature range within which the transport package shall be stored and handled Humidity: accepted humidity transport range within which the transport package shall be stored and handled Lithium battery handling label IP classification: the device is protected from ingress by particles greater than 12 millimeters and protected from water spray less than 15 degrees from vertical SGS North America Listed Mark: NRTL Mark for USA and Canada Non-ionizing radiation / RF 4/157English EN 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. Certification mark: Certifies that the radio equipment device is compliant with the Federal Communications Commission’s (FCC) standards and regulations Industry Canada Certification mark: certifies that the radio equipment device is compliant with Innovation, Science, and Economic Development (ISED) Canada technical regulations and standards Caution: Federal law restricts this device to sale by or on the order of a licensed health care practitioner 5/157English EN Warnings THE DEVICE SHOULD ONLY BE USED WITH THE AUTHORISATION OF YOUR HEALTHCARE PROFESSIONAL KEEP OUT OF REACH OF CHILDREN WHEN NOT UNDER DIRECT SUPERVISION USAGE WITH CHILDREN Children over 5 years old can use Izar™ only in Europe, not in the USA. Children can use Izar™ under the DIRECT supervision of rehabilitation professionals.Children cannot use Izar™ in remote mode or at home RISK OF INJURY Patients have to make only movements that have been instructed by the clinician in order to minimize the risk of injury due to new and incorrectly executed movements. Patients have to follow the therapy session plan prescribed by the rehabilitation specialist KEEP OUT OF REACH OF PETS Keep Izar™, out of the reach of pets and most particularly dogs. A dog crushing Izar™ can generate battery fire or explosion ENVIRONMENTAL WARNINGS • Izar™ is not designed for use in areas where an explosion hazard may occur. 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 • Portable Radio Frequency communications equipment (including peripherals such as antenna cable and external antennas) should be used no closer than 30cm to any part of Izar™ including cables specified by MindMaze. Otherwise, degradation of the performance of this equipment could result 6/157English EN • Use of this equipment adjacent to or stacked with other equipment than MindMotion™ Go should be avoided because it could result in improper operation. If such use is necessary, this equipment and the other equipment should be observed to verify that they are operating normally • Do not immerse the device in water or other liquid. Izar™ is IP22. Izar™ docking station is IPX0 • Before use, allow Izar™ and its docking station to reach room temperature. If the unit has been transported or stored at temperatures below 0°C (32°F), leave it to reach at room temperature for about 2 hours, until any condensation has disappeared. If the unit has been transported or stored at temperatures above 40°C (104°F), leave it to reach at room temperature for about 2 hours • The plug socket must be close to the power adapter and be easily accessible • Before cleaning Izar™and its docking station, unplug the power adapter • Liquids and foreign material (such as dust, metal, etc.) must not be allowed to enter Izar™. If such material…

Text truncated - open the document above for the full version.

EXTERNAL PHOTOS FCC ID: 2AYHHMMIZ-S1 IC: 26802-MMIZS1 2 © SGS SA 2016 ALL RIGHTS RESERVED FRONT (ALL SIDES SAME) 3 © SGS SA 2016 ALL RIGHTS RESERVED TOP 4 © SGS SA 2016 ALL RIGHTS RESERVED BOTTOM WWW.SGS.COM

[mm] Instructions: - Support material: TBD - Font: Open Sans - Logos: To be used as it is - Dimensions (do not print blue) - Cut-out path (do not print ----- ) Mindmaze SA HRo, 31MAY2022 page 1/1 D-2013-LBL-0097-AAB Packaging - fixed data 60.5 110.5 R1 D-2013-LBL-0097-AAB MMIZ-01 -20°C 45°C ≤ 3 months 0°C 30°C > 3 months 1060 hPa 500 hPa -20°C 60°C Genious Healthcare SAS 26 rue Cambaceres 75008 Paris - France MindMaze SA Roseneck 5 1006 Lausanne Switzerland 90% 5% Storage & TransportStorageTransport This device complies with part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) This device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation.

MindMaze SA Roseneck 5 CH-1006 Lausanne D-2013-LBL-0074-AAB FCC ID: 2AYHHMMIZ-S1 MMIZ-S1 13.0 30.0 R1 [mm] Instructions: - Support material: TBD - Font: Open Sans - Logos: To use the vectoriel path - Dimensions (do not print blue) - Cut-out path (do not print ----- ) Mindmaze SA HRo, 04APR2022 page 1/1 D-2013-LBL-0074-AAB Ball- fixed data

INTERNAL PHOTOS FCC ID: 2AYHHMMIZ-S1 IC: 26802-MMIZS1 2 © SGS SA 2016 ALL RIGHTS RESERVED COVERREMOVED 3 © SGS SA 2016 ALL RIGHTS RESERVED TOP VIEW –PCB ATTACHEDTOBASE 4 © SGS SA 2016 ALL RIGHTS RESERVED BOTTOM VIEW –PCB 5 © SGS SA 2016 ALL RIGHTS RESERVED CLOSE-UP -BLE IC WWW.SGS.COM

Test Report Number: 4889901EMC08 Rev:0 MindMaze SA / Izar System Page: 1 of 5 Remarks: This document is issued by the Company subject to its General Conditions of Service printed overleaf, available on request or accessible at http://www.sgs.com//en/Terms-and-Conditions.aspx. And for electronic format documents, subject to Terms and Conditions for Electronic Documents at http://www.sgs.com/en/Terms-and-Conditions/terms-e-document.aspx. Attention is drawn to the limitation of liability, indemnification and jurisdiction issues defined therein. Any holder of this document is advised that information contained hereon reflects the Company’s findings at the time of its intervention only and within the limits of Client’s instructions, if any. The Company’s sole responsibility is to its Client and this document does not exonerate parties to a transaction from exercising all their rights and obligations under the transaction documents. This document cannot be reproduced except in full, without prior written approval of the Company. Any unauthorized alteration, forgery or falsification of the content or appearance of this document is unlawful and offenders may be prosecuted to the fullest extent of the law. Unless otherwise stated the results shown in this test report refer only to the sample(s) tested and such sample(s) are retained for a maximum of 30 days only. RF Exposure Report Project Number: 4889901 Proposal Number: SUW-202202002395 Report Number: 4889901EMC08 Revision Level: 0 Client: MindMaze SA Equipment Under Test: Izar System Model Name: Izar Ball Model Number: MMIZ-S1 Module Model: nrF52840 FCC ID: 2AYHHMMIZ-S1 Applicable Standards: 47 CFR §§ 2.1093 (Portable) FCC KDB 447498 D01 General RF Exposure Guidance v06 Report issued on: July 7, 2022 Result: Exempt from SAR evaluation FOR THE SCOPE OF ACCREDITATION UNDER CERTIFICATE NUMBER: 3212.01 Report must not be used by the client to claim product certification, approval, or endorsement by A2LA, NIST, or any agency of the Federal Government. Prepared by: Brandon Osborn, EMC/RF Project Engineer Reviewed by: Stephen Whalen, SAR/EMC Manager Test Report Number: 4889901EMC08 Rev:0 MindMaze SA / Izar System Page: 2 of 5 SGS North America Inc. Connectivity & Products 620 Old Peachtree Road NW, Suite 100, Suwanee, GA 30024 t (770) 570-1800 www.sgs.com Member of the SGS Group (SGS SA) TABLE OF CONTENTS 1 GENERAL INFORMATION ............................................................................................................................................. 3 1.1 CLIENT INFORMATION ................................................................................................................................................... 3 1.2 TEST LABORATORY ....................................................................................................................................................... 3 1.3 GENERAL INFORMATION OF EUT .................................................................................................................................. 3 1.4 SEPARATION DISTANCE ................................................................................................................................................. 3 2 SAR EXCLUSION CALCULATIONS ............................................................................................................................. 4 3 REVISION HISTORY ........................................................................................................................................................ 5 Test Report Number: 4889901EMC08 Rev:0 MindMaze SA / Izar System Page: 3 of 5 SGS North America Inc. Connectivity & Products 620 Old Peachtree Road NW, Suite 100, Suwanee, GA 30024 t (770) 570-1800 www.sgs.com Member of the SGS Group (SGS SA) 1 General Information 1.1 Client Information Name: MindMaze SA Address: Chemin de Roseneck 5 City, State, Zip, Country: Lausanne, 1006, Switzerland 1.2 Test Laboratory Name: SGS North America, Inc. Address: 620 Old Peachtree Road NW, Suite 100 City, State, Zip, Country: Suwanee, GA 30024, USA Accrediting Body: A2LA Type of lab: Testing Laboratory Certificate Number: 3212.01 1.3 General Information of EUT Type of Product: Izar System Model Name: Izar Ball Model Number: MMIZ-S1 Serial Number: IZAR-0E00086 Module Models: nrF52840 Frequency Ranges: 2402-2480MHz Bluetooth Low Energy – GFSK (S8, S2, 1M, and 2M Data Rates) Antenna Gain: SMT Antenna, 3.5dBi* (antenova, P/N: SR4W035) Max Conducted Output Power: Bluetooth LE: 8dBm* (7.31dBm measured) Sample Received Date: 14 March 2022 Dates of testing: 23 March to 4 April 2022 *Data was not measured by SGS laboratory and therefore not responsible for accuracy. Data obtained via customer, specification sheet, previous regulatory filing or other. 1.4 Separation Distance The closest exposure distance occurs when a user grasps the Izar Ball. Shortest distance from the hand to the antenna is 20mm. Test Report Number: 4889901EMC08 Rev:0 MindMaze SA / Izar System Page: 4 of 5 SGS North America Inc. Connectivity & Products 620 Old Peachtree Road NW, Suite 100, Suwanee, GA 30024 t (770) 570-1800 www.sgs.com Member of the SGS Group (SGS SA) 2 SAR Exclusion Calculations The highest output power in conjunction with the Upper and Lower frequency boundaries have been used to demonstrate compliance. Power levels were referenced from the BLE report, 4889901EMC03. The EUT is considered an extremity application. Bluetooth LE (FCC ID: 2AYHHMMIZ-S1) Input Select Units Unit correction Max Power:10.81dBm12.050359412 Duty Cycle:100.0% Min separation distance:20mm20 Frequency, f:2402MHz2402100 Value reference Number v112.000mW v220mm v31.550 a) Exclusion Calculation(1g):0.9299number Exclusion Calculation(10g):0.9299number Conclusions (Body): Conclusions (Extremity): Values used for Calculation For 100 MHz to 6 GHz and test separation distances ≤ 50 mm, the 1-g and 10-g SAR test exclusion thresholds are determined by the following: 44749…

Text truncated - open the document above for the full version.

Test Report Number: 4889901EMC03 Rev: 1 MindMaze SA / Izar Ball Page: 1 of 40 Remarks: This document is issued by the Company subject to its General Conditions of Service printed overleaf, available on request or accessible at http://www.sgs.com//en/Terms-and-Conditions.aspx. And for electronic format documents, subject to Terms and Conditions for Electronic Documents at http://www.sgs.com/en/Terms-and-Conditions/terms-e-document.aspx. Attention is drawn to the limitation of liability, indemnification and jurisdiction issues defined therein. Any holder of this document is advised that information contained hereon reflects the Company’s findings at the time of its intervention only and within the limits of Client’s instructions, if any. The Company’s sole responsibility is to its Client and this document does not exonerate parties to a transaction from exercising all their rights and obligations under the transaction documents. This document cannot be reproduced except in full, without prior written approval of the Company. Any unauthorized alteration, forgery or falsification of the content or appearance of this document is unlawful and offenders may be prosecuted to the fullest extent of the law. Unless otherwise stated the results shown in this test report refer only to the sample(s) tested and such sample(s) are retained for a maximum of 30 days only. RF Test Report Project Number: 4889901 Proposal: SUW-202202002395 Report Number: 4889901EMC03 Revision Level: 1 Client: MindMaze SA Equipment Under Test: Izar Ball Model Number: MMIZ-S1 HVIN: Izar Ball FCC ID: 2AYHHMMIZ-S1 IC: 26802-MMIZS1 Applicable Standards: ANSI C63.10: 2013 (FCC Part 15 Subpart C, § 15.247) RSS-247, Issue 2 RSS-GEN Issue 5 Report issued on: 07 November 2022 Test Result: Compliant FOR THE SCOPE OF ACCREDITATION UNDER CERTIFICATE NUMBER: 3212.01 This report must not be used by the client to claim product certification, approval, or endorsement by A2LA, NIST, or any agency of the Federal Government. Prepared by: Brandon Osborn, EMC / RF Project Engineer Reviewed by: Martin Taylor, Sr. RF Project Engineer Test Report Number: 4889901EMC03 Rev: 1 MindMaze SA / Izar Ball Page: 2 of 40 SGS North America Inc. Connectivity & Products 620 Old Peachtree Road NW, Suite 100, Suwanee, GA 30024 t (770) 570-1800 www.sgs.com Member of the SGS Group (SGS SA) Table of Contents 1 SUMMARY OF TEST RESULTS ..................................................................................................................................... 4 1.1 MODIFICATIONS REQUIRED FOR COMPLIANCE .............................................................................................................. 4 2 GENERAL INFORMATION ............................................................................................................................................. 5 2.1 CLIENT INFORMATION ................................................................................................................................................... 5 2.2 TEST LABORATORY ....................................................................................................................................................... 5 2.3 GENERAL INFORMATION OF EUT .................................................................................................................................. 5 2.4 OPERATING MODES AND CONDITIONS .......................................................................................................................... 5 2.5 EUT CONNECTION BLOCK DIAGRAM – CONDUCTED MEASUREMENTS ......................................................................... 6 2.6 EUT CONNECTION BLOCK DIAGRAM – RADIATED MEASUREMENTS ............................................................................ 6 2.7 SYSTEM CONFIGURATIONS ............................................................................................................................................ 7 2.8 CONFIGURATION DIAGRAMS (RADIATED) ..................................................................................................................... 7 3 INTENTIONAL RADIATOR ANTENNA REQUIREMENT ........................................................................................ 8 3.1 RESULT.......................................................................................................................................................................... 8 3.2 REQUIREMENT ............................................................................................................................................................... 8 3.3 CONCLUSION ................................................................................................................................................................. 8 4 BANDWIDTH ..................................................................................................................................................................... 9 4.1 TEST RESULT ................................................................................................................................................................. 9 4.2 TEST METHOD ............................................................................................................................................................... 9 4.3 TEST SITE ...................................................................................................................................................................... 9 4.4 TEST EQUIPMENT .......................................................................................................................................................... 9 4.5 TEST DATA – 6DB BANDWIDTH .................................................................................................................................. 10 4.6 TEST DATA – 99% BANDWIDTH .................................................................................................................…

Text truncated - open the document above for the full version.

TEST SETUP PHOTOGRAPHS Applicant: MindMazeSA Model –MMIZ-S1 FCC ID: 2AYHHMMIZ-S1 IC:26802-MMIZS1 2 30-1000 MHZ -FRONT VIEW 3 30-1000MHZ -REAR VIEW 4 1-18GHZ -FRONT VIEW 5 1-18GHZ –REAR VIEW WWW.SGS.COM © SGS Group Management SA – 2016 – All rights reserved - SGS is a registered trademark of SGS Group Management SA