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11. L

EGAL

ANUFACTURER

Mindmaze SA
Chemin de Roseneck, 5
1006 Lausanne
Switzerland

Email:

[email protected]

Web:

www.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:

[email protected]

Support Mail:

[email protected]

Web:

www.gaitup.com

ENGLISH

84/84

Содержание GAIT UP GO

Страница 1: ...lementary instructions Table 4 Automatic test end criteria Test type Stop automatically after Monopodal balance comparison 30 seconds x 2 One leg balance 30 seconds Balance on two legs 30 seconds Semi...

Страница 2: ...rate the sensor device from the Gait Up GO mobile application further than 5 meters 16 feet At the end of the test if it did not automatically stop tap the End button appearing on your screen to compl...

Страница 3: ...se cases an error message is popping up on the screen warning the user who has the choice of deciding whether the recorded raw data no personal or clinical data contained in the recorded raw data is s...

Страница 4: ...saved Android After tapping OK on the information text box the mobile application displays the session screen from where the user can select another test in the list The test report can later be acces...

Страница 5: ...professional the user cannot generate a test report directly at the end of the test In order to generate the report for the performed test it is required to login to the password protected part of the...

Страница 6: ...tected part In order to access and manage all past reports and generate reports in case the direct access to results is not activated the medical professional needs to login to the password protected...

Страница 7: ...ows to validate the spending of one credit to generate and unlock the report NOTE All tests recorded with a Physilog6 attributed to an unlimited license are automatically unlocked NOTE In order to gen...

Страница 8: ...Reports are deleted from the list by sliding the list entry to the left or right of the screen To permanently delete the report press confirm in the pop up window Be careful deleted reports cannot be...

Страница 9: ...in a computer where the Participant folder is located To share the reports tap on the text or pdf symbols located in the upper right corner of the screen There are different sharing options such as vi...

Страница 10: ...eight Use or not of Walking aid Health condition d Comments The comment added to the participant profile and the comment added at the end of the test e Clinical result The first result is for all test...

Страница 11: ...f or text format for sharing and sending it to a computer or electronic patient record file position of the result on the colorbar The units of the result value are also indicated g Normative threshol...

Страница 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...

Страница 13: ...ear 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 A lin...

Страница 14: ...lution to clean and disinfect the physilog6 sensor device s plastic enclosure Do not use a cleaning spray but carefully wipe it using a humid wipe Liquids and foreign material e g dust must not be all...

Страница 15: ...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 3...

Страница 16: ...or independent use make sure that the linked sensor corresponds to the sensor device accessory you provide and is correctly connecting to the mobile application The setting of the linked sensor device...

Страница 17: ...s not have enough battery to start or continue a recording and that you should recharge it In case that the mobile application can solve the sensor device accessory problem on it s own the sensor devi...

Страница 18: ...ay General contact email contact gaitup com Email support gaitup com Reporting an adverse event If any serious incident occurs that is directly or indirectly related to the use of Gait Up GO medical d...

Страница 19: ...address specified by Gait Up For specific instructions on how to obtain warranty service on your product contact Gait Up at support gaitup com Gait Up does not warrant that the operation of the produ...

Страница 20: ...e In case of rejection it is recommended to follow this procedure Clean carefully the Physilog6 sensor device and the clip accessories following the cleaning procedure described under section 5 Contac...

Страница 21: ...rdant acrylonitrile butadiene styrene ABS copolymer Clip accessories CYCOLAC RESIN HMG94MD Acrylonitrile Butadiene Styrene ABS for medical applications USP grade IV USB cable PVC Power source Internal...

Страница 22: ...Phone CISPR 32 compliant Yes RoHS compliant Yes Wi FI connectivity Yes Bluetooth wireless communication Bluetooth 4 0 or higher with BLE frequency of 128Hz or higher Minimum screen size 4 7 inch Minim...

Страница 23: ...0 or higher and iOS 11 0 0 or higher Battery life 3 hours Symbol Description Legal manufacturer Reference number CE mark Read Accompanying document Do not send the device or any of its accessories to...

Страница 24: ...o 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 ra...

Страница 25: ...end user of the Gait Up GO medical device should ensure it is used in such an environment Lithium battery handling label Device under prescription logo System Characteristics Description Function Reco...

Страница 26: ...idance Electrostatic discharge ESD IEC 61000 4 2 15 kV Air 2 4 8 15 kV Contact 15 kV Air 2 4 8 15 kV Contact Floors should be wood concrete or ceramic tile If floors are covered with synthetic materia...

Страница 27: ...IEC 61000 4 3 10 V m 80MHz 2 7GHz 80 AM 1kHz 10 V m 80MHz 2 7GHz 80 AM 1kHz Portable and mobile RF communications equipment should be used no closer to any part of the Physilog6 sensor device includin...

Страница 28: ...n the vicinity of the equipment marked with the non ionizing radiation symbol Proximity fields emitted by RF wireless communication devices IEC 61000 4 3 Frequency MHz Modulation Level V m Conformity...

Страница 29: ...be necessary such as reorienting or relocation of the Gait Up GO medical device Note b Over the frequency range 150 kHz to 80 MHz field strengths should be less than 3V m 9 6 Recommended separation d...

Страница 30: ...n Rated maximum output power of transmitter 80 KHz to 1000 Mhz outside ISM bands 1GHz to 2 7GHz outside ISM bands 2 7GHz to 6GHz outside ISM bands d 0 6 sqrt P d 0 6 sqrt P d 2 sqrt P 0 01W 0 06 0 06...

Страница 31: ...on exposure limits set forth for general population This device must not be co located or operating in conjunction with any other antenna or transmitter Caution the user that changes or modifications...

Страница 32: ...lectrique l intention des autres utilisateurs il faut choisir le type d antenne et son gain de sorte que la puissance isotrope rayonn e quivalente p i r e ne d passe pas l intensit n cessaire l tablis...

Страница 33: ...antenne ou un autre metteur Note La distance de s paration entre l utilisateur et ou le spectateur et l antenne et ou l l ment rayonnant de l appareil est d au moins 20 mm 9 9 RF exposure compliance E...

Страница 34: ...10 A LPHABETICAL INDEX ENGLISH 83 84...

Страница 35: ...o mindmaze com Web www 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 conta...

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