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Gait up GO Instructions For Use Manual

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ENGLISH
D-2017-LBL-0083-AAA – Sep 2020

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Summary of Contents for Gait up GAIT UP GO

  • Page 1 ENGLISH D-2017-LBL-0083-AAA – Sep 2020...
  • Page 2 ​ I​ U​ N STRUCTIONS​ F OR​ ​ H​ O ME​ U SE G​ U​ P ​ A IT​ ENGLISH 2/51...
  • Page 3 Mindmaze SA Chemin de Roseneck, 5 1006 Lausanne Switzerland Contact email: xxxxxxxx Website: ​ w ww.mindmaze.ch Commercialized by​ : Gait Up SA EPFL Innovation Park Batiment C CH-1015 Lausanne Switzerland General Contact email: ​ c ontact@gaitup.com Website: ​ h ttps://clinical.gaitup.com/ Support email: ​...

  • Page 4: Table Of Contents

    ​ T​ C​ A BLE​ O F​ O NTENT 6 ​ ​ ​ 4.5.3 P​ H YSILOG​ S ENSOR​ D EVICE​ I NFORMATION T​ ​ C​ SCREEN A BLE​ O F​ O NTENT ​ ​ 4.5.4 P​ E RFORMING​ A ​ T EST T​...

  • Page 5: A Bleo F I Gures

    ​ T​ F​ A BLE​ O F​ I GURES Fig. 1 Fig. 2a Fig. 2b Fig. 3 Fig. 4 Fig. 5 Fig. 6 Fig. 7 Fig. 8 Fig. 9 Fig. 10 Fig. 11 Fig. 12 Fig. 13a Fig. 13b Fig. 14 Fig.

  • Page 6: I N Dexo F T Ables

    ​ I​ N DEX​ O F​ T ABLES Table 1. Definitions Table 2. Gait Up GO components Table 3. Physilog6 sensor components 16 Table 4. Automatic test end criteria Table 5. Troubleshooting Table 6. Technical specifications Table 7. Symbols Table 8. EMI emissions Table 9.

  • Page 7: S A Fetyi Nformation

    1.1. Warnings 1.1.1. Warnings related to the operating conditions of the device ● Do not use Gait Up GO medical device in the near proximity of Active Implantable Medical Devices (AIMD), medical devices that have direct impact on the health condition of the patient or life supporting medical devices.

  • Page 8: Cautions

    1.1.2. Warnings related to the conditions and awareness of the end-users ● DO NOT use the Gait Up GO in other parts of the Participant body but in the ones indicated in the Instructions For Use. ● DO NOT manipulate or remove Gait Up Go accessories from the user body during the session.

  • Page 9: Adverse Reactions

    ● Any part of the Gait Up GO must not be maintained or serviced while the device is in use; do not perform an operating system update of the mobile phone/tablet during or when you have planned to use the device.
  • Page 10 Any serious incident having occurred in relation to Gait Up GO medical device should be reported to the legal manufacturer (Mindmaze SA) and the competent authority of the Member State in which the user and/or the Participant is established. Inform your Healthacre Professional who has prescribed you the medical device if you notice adverse reactions.

  • Page 11: B E Foreu Se

    Gait Up GO is also used to assess risk of injury for prevention in recreational and professional athletes of all ages (such as any person performing a sport activity).

  • Page 12: N Dicationsf Oru Se

    2.3. Indications for use GaitUp GO is a medical device indicated for mobility and physical condition parameter assessment in: ● child (any gender): 2 - 12 years old ● adolescent (any gender): aged 12 through 21 (up to but not including the 22nd birthday) ●...

  • Page 13: D E Scription

    Gait Up GO medical device can be operated only through a mobile phone (iOS & Android) or a tablet (iOS & Android) where Gait Up GO app has been installed: ●...
  • Page 14 3.2. Description of device components Fig 1. Gait Up GO device components Gait Up Go Mobile Application Fig 2a. Android application Fig 2b. iOS application ENGLISH 14/51...

  • Page 15: P H Ysilog 6 S Ensor

    Professionals to interpret it. ● update the Firmware of the Physilog6 sensor device accessory The Gait Up GO Mobile application runs on off the shelf Android and iOS mobile phones and tablets. The Gait Up GO Mobile application provides guidance to the users on how and where to place the Physilog6 sensor device on the Participant’s body (see section 4 for further details)
  • Page 16 Physilog6 goes into stand-by mode. By lightly shaking the device, the BLE turns on and the sensor device and the mobile application automatically connect over Bluetooth. The Physilog6 accessory device is composed of: Component Function a) Body of the Encloses all the electronics and the battery. The Physilog6 sensor device device is water and dustproof according to the standard IP64.
  • Page 17 Fig 4. Fixation clip accessories USB cable USB-A to USB-C cable, included in the Gait Up GO medical device packaging, is used to charge the battery of the Physilog6 sensor device by connecting it to a computer or to a mobile phone charger compatible with the specifications set under section 9 of the present document.
  • Page 18 3.3 User indicators 3.3.1 Visual user indicators related to battery charging 3.3.2 Visual and auditory indicators related to the operation of the device Physilog6 sensor device visual and auditory indicators ENGLISH 18/51...
  • Page 19 Gait Up GO mobile application visual indicators 1. Information messages 2. Error messages ENGLISH 19/51...
  • Page 20 It is important however, for you to carefully watch the Gait Up GO medical device and all its accessories to make sure that the device is working properly while you are using it alone at home. In this document there is some important information you should read and understand carefully.
  • Page 21 It is not possible to recharge the battery during the device operation. That is why, please check the battery level of the Physilog6 sensor device on the Gait Up GO Mobile Application screen before starting any test (see section 4.5.5).
  • Page 22 Note: In case of lack of integrity of one or more components of the Gait Up GO medical device, please immediately contact the customer support. ● Clean the Physilog6 sensor device and the clip accessories before using the device. See section 5.
  • Page 23 Fig 6: Main participant screen 4.5.2 Connecting Physilog6 sensor device to the mobile application In order to connect the Physilog6 sensor device to the mobile application, follow the next steps: ● Open the mobile application ● Gently shake the sensor device ●...
  • Page 24 NOTE: To “wake up” the Physilog6 sensor from stand-by mode when it is not connected, lightly shake the device to turn on its BLE (“shake up to wake up”). Note: In order to be able to connect your device to the mobile application, the bluetooth option needs to be activated.
  • Page 25 Fig 9: Location of the icon to access the Physilog6 sensor device information screen The screen will provide you information about the connection status of the sensor device, its battery level and the firmware version running on it. In case there is a firmware update available, this screen will notify it to you and will give you the option of performing such an update.
  • Page 26 To be able to use the Gait Up GO medical device, the firmware of the Physilog6 sensor needs to be at the latest version. Physilog6 can be updated from the Gait Up GO application. In case the Physilog6 sensor firmware is not up to date with the Gait Up GO mobile application version, the sensor information window will include a button named “Update Physilog”.
  • Page 27 ​ F igure 9. If the battery is lower than 25%, the Gait Up GO Mobile Application will not allow it to start any test. The battery level indicating the battery status of the connected Physilog6 sensor device on the Mobile Application Screen is shown in Figure 11.
  • Page 28 Depending on the test choice, instructions and sensor locations are different. Be careful to correctly place the sensor at the location indicated in the test instructions provided inside the Gait Up GO application. For any question, please contact the Healthcare Professional who prescribed you the medical device.
  • Page 29 Carefully read the instructions given in the Gait Up GO Mobile Application for the selected test to know where to place the sensor.
  • Page 30 The clip accessories must not be in contact with the participant’s skin. Once the sensor device is securely and firmly attached to the end-user’s body, tap on “Ready” NOTE: For each of the tests contained in the Gait Up GO mobile application it is important to not move before tapping “Go”.
  • Page 31 Test type Stop automatically after: Monopodal balance comparison 30 seconds (x 2) One leg balance 30 seconds Balance on two legs 30 seconds Semi-tandem balance 30 seconds Tandem balance 30 seconds Romberg test 30 seconds (x 2) Sit to stand transfer 5 sit to stand detected Vertical jump 1 leg 1 jump detected (x 2)
  • Page 32 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 complete the recording. The Gait Up GO medical device will analyze the recorded data.
  • Page 33 (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 34 Fig. 23 Pop-up in case of error during the recording NOTE: The previous test is an example (jump test) in the Gait Up GO application but the same procedure should be used for all the tests contained in the mobile application.

  • Page 35: L Eaninga Intenancea Nd

    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 4.5.3.
  • Page 36 ● 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 37 "Update you update the Gait Up GO displays an error incompatible Physilog" button. mobile device or after pop-up after you firmware installation of the select a test, version.
  • Page 38 When and how to perform a manual reset of the Physilog6 sensor device accessory In case the Physilog6 sensor cannot be connected to the Gait Up GO mobile application, after controlling that the correct sensor is linked, that it has enough battery and is in proximity and after restarting the Gait Up GO mobile application, a reset of the Physilog6 device can solve the problem.

  • Page 39: Reporting An Adverse Event

    ● Release the button and wait until the blinking stops. 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 your healthcare provider who prescribed you the...
  • Page 40 7. 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). Disposal of Gait Up GO medical device (incl. all its accessories) The Gait Up GO medical device is composed of electrical and electronic components such as the battery included in the Physilog6 sensor device.

  • Page 41: Environmental Conditions

    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 42 ● Humidity:[10-70]% ● Pressure: [600-1070] hPA Storage: ● Temperature:[-20- +60]°C ● 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 ●...

  • Page 43: Symbols

    Wi-FI connectivity Bluetooth wireless Bluetooth 4.0 or higher communication Minimum screen size 8 inch Minimum screen 1200x1920 resolution Android (7.0 or higher) and iOS (11..0.0 or higher) Battery life > 3 hours Table 6. Technical specifications 8.2. Symbols Symbol Description Legal manufacturer Reference number CE mark...
  • Page 44 Caution Logo Warning Logo Applied part logo Accepted humidity range Accepted temperature range Non-ionizing radiation FCC symbol (USA) IC symbol (Canada) Fragile; handle with care ENGLISH 44/51...

  • Page 45: Emie Missions

    Storage logo keep away from sunlight Storage logo Keep away from rain Lithium battery handling label Device under prescription logo Table 7. Symbols 8.3. EMI emissions System Characteristics Description Function Recording Frequency (mHz) 2402-2480 Max. declared output power (dBm) Max. antenna gain (dBi) Max.

  • Page 46: Guidance

    IEC 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 environment...
  • Page 47 should be at least 30%. Note: Some ESD events might cause the unexpected reset of the Physilog6 sensor device. If after the unexpected reset, the device seems blocked, please perform a manual reset (see section 6.1) Electrical fast DC input +/- 2kV, 100 DC input +/- 2kV, 100 USB cable must be transients/burst...
  • Page 48 separation distance calculated from the equation applicable to the frequency of the transmitter Recommended separation distance: XX ask lab for equations Where P s the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in meters (m) (b).
  • Page 49 RF compliance level above, theGait 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 50: L Phabeticali Ndex

    ​ 9. A​ L PHABETICAL​ I NDEX ENGLISH 50/51...
  • Page 51 Chemin de Roseneck, 5 1006 Lausanne Switzerland 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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