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NOTE : some tests stop automatically after the movement is completed or after a fixed amount of time
(f.ex. 2min walking test, 5 sit to stand test). For more information about the test, check the
complementary instructions which can be accessed by clicking on the question mark button on the
right side of the test title on the instructions screen.
Test type
Monopodal balance comparison
One leg balance
Balance on two legs
Semi-tandem balance
Tandem balance
Romberg test
Sit to stand transfer
Vertical jump 1 leg
Vertical jump 2 legs
2 minutes walking test
Timed Up and Go
Timed Up and Go in dual task
ENGLISH
Fig. 65. Complementary instructions
Stop automatically after:
30 seconds (x 2)
30 seconds
30 seconds
30 seconds
30 seconds
30 seconds (x 2)
5 sit to stand detected
1 jump detected (x 2)
3 jumps detected
2 minutes
1 Timed Up and Go detected
1 Timed Up and Go detected
Table 4. Automatic test end criteria
50/84

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Summary of Contents for Gait up GO

  • Page 1 3 jumps detected 2 minutes walking test 2 minutes Timed Up and Go 1 Timed Up and Go detected Timed Up and Go in dual task 1 Timed Up and Go detected Table 4. Automatic test end criteria ENGLISH 50/84...
  • Page 2 Fig. 67. Instruction test start - Android NOTE: The wireless communication between the Physilog6 sensor device accessory and the mobile phone / tablet is limited in distance. Do not separate the sensor device from the Gait Up GO mobile application further than 5 meters (16 feet).
  • Page 3 (no personal or clinical data contained in the recorded raw data) is shared with Gait Up or not. Data sharing has uniquely the goal of helping Gait Up SA to improve the product. To share such data, a user account must be registered on the mobile phone/tablet and internet access is required.
  • Page 4 The test report can later be accessed by the medical professional inside the password protected part of the Gait Up GO mobile application (see section 4.5.8). End of the test with Limited admin mode (direct access to the results) If the “Direct access to results”...
  • Page 5 4.5.8 Generate, manage and interpret test reports The Gait Up GO medical device works with a pay per report model, where the user can perform as many tests as wanted for free and needs to spend credits only when generating and displaying the result reports.
  • Page 6 Fig. 75. Confirmation request - iOS NOTE: In order to generate reports, the Gait Up GO Mobile Application needs to be connected to the Internet by using WiFi or mobile data. Fig. 76. Report generated - iOS - Android After generating the report, it will always be available inside the password protected space (see section 4.5.8).
  • Page 7 NOTE: All tests recorded with a Physilog6 attributed to an unlimited license are automatically unlocked. NOTE: In order to generate reports, the Gait Up GO Mobile Application needs to be connected to the Internet by using WiFi or mobile data.
  • Page 8 (see section 4.5.9.). It is recommended to save all reports to a computer to avoid loss of data due to bad manipulation inside the Gait Up GO mobile application (see section 4.5.8). Credits spent to unlock reports are not restituted when deleting a report.
  • Page 9 Sharing a report The Gait Up GO mobile application should never serve as a storage unit for the generated reports. Each time a report is generated for a specific patient, it is recommended that it is shared and saved in a computer where the Participant folder is located.
  • Page 10 The first result is for all tests the main clinical result associated with the clinical test. This is the result obtained from performing the same clinical test without Gait Up GO medical device. f) Test result value Result value for a given parameter. The color adapts accordingly to the...
  • Page 11 Results in the green area are equal or better than the result of similar Participants presented in the literature. i) Additional results Additional result parameters which are calculated thanks to Gait Up GO and the presence of the Physilog6 sensor which records the movement data during the test.
  • Page 12 Fig. 84. How to access to the “History” section - iOS Fig. 85. How to access to the “History” section - Android Comparison report interpretation ENGLISH 61/84...
  • Page 13 Fig. 86. Comparison report example and its components Report component Description a) Test name Name of the performed test b) Participant Summary of participant information including: information ● Name ● Gender ● Birth year ● Height c) Parameter name Name of the result parameter with its icon d) Result values For each report generated for this test and participant, the test result value of the parameter is displayed.
  • Page 14: Cleaning, Maintenance And Storage

    ● If the Gait Up GO medical device (incl. all its accessories) shows functional instabilities or any visual defects, stop using it and contact the customer service. The ​ P hysilog®6 ​ f irmware is updated using the Gait Up GO mobile application provided by Gait Up SA according to the instructions of use section 4.5.5.
  • Page 15: Environmental Conditions For Operation

    ● Store it in a cool (-20 - +60°C) and dry place at a stable temperature and ambient humidity (25%-70%, non-condensing). 5.4. Environmental conditions for operation. The Gait Up GO medical device must be used in accordance with the following conditions: ● Temperature: [0-30] °C ● Humidity: [10-70]% ●...
  • Page 16: Troubleshooting

    Problem What to do More Information see/hear The Gait Up GO There is a Make sure that the Before handing a Gait Up GO mobile problem with sensor device accessory device to a Participant for application the connection is in proximity of your...
  • Page 17 Gait Up GO mobile application, a reset of the Physilog6 device can solve the problem. •Unplug Physilog6 if it is charging.
  • Page 18: Customer Support

    Reporting an adverse event If any serious incident occurs that is directly or indirectly related to the use of Gait Up GO medical device, please report it immediately to the legal manufacturer (Mindmaze SA) and to the competent authority of your country and of where the Participant is established (if different).
  • Page 19 Gait Up’s website. 8. D​ I SPOSAL The expected service life of the Gait Up GO medical device and all its accessories is 2 years of normal usage (300 assessment sessions per month under the specified operating conditions). ENGLISH...
  • Page 20 5 ● Contact Gait Up SA customer support to get shipping information Gait Up SA will take care of the treatment, collection, recycling and disposal of all the components of the Gait Up GO medical device.
  • Page 21: Specifications

    Power plug USB-C Battery life Number of recharging cycles > 500 cycles User indicators ● Gait Up GO mobile application: User Interface ● Physilog6 sensor device: LED and beeper Communications Bluetooth Low Frequency (BLE). frequency band: 2.402-2.480 GHz (TX & RX) Effective radiated power (max): 11.11 dBm...
  • Page 22 ● Humidity:[25-70]% ● Pressure: [600-1070] hPA Transportation: ● Temperature:[-20-60]°C ● Humidity:[25-70]% ● Pressure: [600-1070] hPA Protection IP64 Mobile phone charger Minimum specifications ● Input voltage: 100-240V AC, 50-60 Hz ● Output voltage: DC 5V 3A/9V 2A/12V 1.5A ● Efficiency: >85% ●...
  • Page 23 Android (7.0 or higher) and iOS (11..0.0 or higher) Battery life > 3 hours Table 8. Technical specifications 9.2. Symbols Symbol Description Legal manufacturer Reference number CE mark Read Accompanying document Do not send the device or any of its accessories to a standard garbage Caution Logo Warning Logo ENGLISH...
  • Page 24 Applied part logo Accepted humidity range Accepted temperature range Non-ionizing radiation FCC symbol (USA) IC symbol (Canada) Fragile; handle with care Storage logo keep away from sunlight Storage logo Keep away from rain ENGLISH 73/84...
  • Page 25: Guidance And Manufacturer's Declaration - Electromagnetic Emissions

    60601-1-2 international standard. The Gait Up GO medical device is intended for use in the electromagnetic environment specified below. The user and/or end-user of the Gait Up GO medical device should ensure it is used in such an environment. Emissions test...
  • Page 26: Guidance And Manufacturer's Declaration - Electromagnetic Immunity

    RF emissions CISPR 11 Class B Gait Up GO medical device is intended to be used in home environment Harmonic emissions IEC 61000-3-2 Voltage fluctuations/ Flockers...
  • Page 27 IEC 61000-4-5 Voltage dips, short N/A (DC supply) interruptions and voltage variations on power supply lines IEC 61000-4-11 Frequency (50/60 Hz) 30 A/m, 50 or 60 Hz 30 A/m, 50 or 60 Hz Power frequency magnetic field tested in X, Y and Z magnetic fields should IEC 61000-4-8 axes.
  • Page 28 manufacturer ● D is the recommended separation distance in meters (m) (b). Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey (a), should be less than the compliance level in each frequency range Interference may occur in the vicinity of the equipment marked with the non-ionizing...
  • Page 29 RF compliance level above, the Gait Up GO medical 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 Gait Up GO medical device.
  • Page 30: Fcc - Information To User

    Rated maximum 80 KHz to 1000 Mhz 1GHz to 2.7GHz 2.7GHz to 6GHz output power of outside ISM bands outside ISM bands outside ISM bands transmitter d=0.6*sqrt(P)** d=0.6*sqrt(P)** d=2*sqrt(P)** 0.01W 0.06 0.06 0.1W 0.19 0.19 0.63 1.90 1.90 6.32 100W For transmitters rated at a maximum output power not listed above, the recommended separation distance d in metres [m] can be determined 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...
  • Page 31 NOTE: This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference in a residential installation. This equipment generates, uses and can radiate radio frequency energy and, if not installed and used in accordance with the instruction, may cause harmful interference to radio communications.
  • Page 32 population. This device must not be co-located or operating in conjunction with any other antenna or transmitter. 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: ●...
  • Page 33 IC Exposition humaine - Version française Le présent appareil est conforme aux niveaux limites d'exigences d'exposition RF aux personnes définies par ISDE. L’appareil ne doit pas être installé à proximité ou être utilisé en conjonction avec une autre antenne ou un autre émetteur. Note : La distance de séparation entre l'utilisateur et/ou le spectateur et l'antenne et/ou l'élément rayonnant de l'appareil est d'au moins 20 mm.
  • Page 34 ​ 10. A​ L PHABETICAL​ I NDEX ENGLISH 83/84...
  • Page 35 Switzerland Email: ​ i nfo@mindmaze.com Web: ​ w ww.mindmaze.ch Commercialized by: Gait Up SA EPFL Innovation Park Batiment C 1015 Lausanne Switzerland Tel: +41 21 633 75 27 (office hours: 8h30 - 17h30 CET, Monday to Friday) General contact Mail: ​...

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