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Gait up GO Instructions For Use Manual

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ENGLISH
D-2017-LBL-0086-AAF – Jan 2021

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Summary of Contents for Gait up GO

  • Page 1 ENGLISH D-2017-LBL-0086-AAF – Jan 2021...
  • Page 2 ​ I​ U​ N STRUCTIONS​ F OR​ G​ U​ P ​ A IT​ ENGLISH 2/84...
  • Page 3 Chemin de Roseneck, 5 1006 Lausanne Switzerland Contact email: ​ i nfo@mindmaze.com Website: ​ w ww.mindmaze.ch Commercialized by​ : Gait Up SA EPFL Innovation Park Batiment C CH-1015 Lausanne Switzerland FCC ID: 2AYHH-PHY06GAITUP IC ID: 26802-PHY06GAITUP General Contact email: ​...

  • Page 4: Table Of Contents

    Instructions for Use THE​ O PERATION​ O F​ T HE​ D EVICE Physilog6 sensor device visual and Gait Up GO auditory indicators Gait Up GO mobile application visual T​ ​ C​ A BLE​ O F​ O NTENT indicators T​ ​...
  • Page 5 A N​ A SSESSMENT​ S ESSION Assign tests 8. D​ I SPOSAL Limited admin mode Disposal of Gait Up GO medical device (incl. all its accessories) Assessment session screen Preparing the device for Home use by 9. T​ S​ E CHNICAL​...
  • Page 6 ​ T​ F​ A BLE​ O F​ I GURES Fig. 43 Fig. 1 Fig. 44 Fig. 2a Fig. 45 Fig. 2b Fig. 46 Fig. 3 Fig. 47 Fig. 4 Fig. 48 Fig. 5 Fig. 49 Fig. 6 Fig. 50 Fig. 7 Fig.

  • Page 7: 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 Table 4. Automatic test end criteria Table 5. List of report components and their description Table 6. List of comparison report components and their description Table 7.

  • Page 8: A Fetyi Nformation

    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 9 ● Operate the Gait Up GO medical device at ambient room conditions in terms of temperature (0°C - 30°C), humidity (10%-70% - non-condensing) and pressure (600 to 1070 hPa). ● Store Gait Up GO medical device in a safe place out of reach of people not trained for a safe device use.

  • Page 10: Cautions

    ● Any part of the Gait Up GO must not be maintained or serviced while the device is in use; do not perform an OS update of the mobile phone/tablet during or when you have planned to use the device.

  • Page 11: Adverse Reactions

    1.4. Adverse reactions In the unlikely event that any adverse reactions occur in participants, stop using Gait Up GO medical device immediately. 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.

  • Page 12: B E Foreu Se

    Furthermore, the device quantifies patients' physical performance which can be used to understand the impact of treatments and/or rehabilitation therapies on the patients. 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 13: N Tendedu Serp Opulation

    It can be used in hospital, clinics, rehabilitation centers and indoor home environments. The device is not indicated for uses other than that described in the IFU and labelling. GaitUp GO is a Px only (under prescription) Medical Device.

  • Page 14: Healthy Population

    ● Minimum knowledge required: understand instructions ● Minimum experience for proper product usage: no minimum experience required 2.6. Essential performance The Gait Up Go medical device does not have any essential performance according to ​ I EC 60601-1:2005+AMD1:2012 CSV. ENGLISH...

  • Page 15: Description

    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 16 Fig 2a. Android application Fig 2b. iOS application Gait Up GO Mobile Application is a software used to: ● wirelessly communicate with the Physilog6 sensor accessory via BLE ● set and provide instructions about the different tests intended for the Participant to perform ●...

  • Page 17: M O Bile A P Plication

    ● provide access to the electronic version of the IFU and the quick start guide 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 18 Component Function a) Body of the It includes a moulded non-flammable ABS casing which embeds the electronics device and the battery of the Physilog6 sensor device. The electronics are composed of a microcontroller with a wireless communication unit that transmits bidirectional information between the device and the mobile phone/tablet, the sensors (IMU, magnetometer and barometer), a power management circuitry, a flash memory, a LED, a button, a beeper, a RF ISM ceramic antenna and a safety...
  • Page 19 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 20: User Indicators

    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 20/84...

  • Page 21: Gait Up Go Mobile Application Visual Indicators

    Gait Up GO mobile application visual indicators 1. Information messages 2. Error messages ENGLISH 21/84...
  • Page 22 3. Confirmation messages ENGLISH 22/84...

  • Page 23: S E

    Please, refer to section 1. Safety Information. 4.1. Overview Gait Up GO medical device enables the recording and analysis of some protocolarized motion tests to assist in the assessment of: the condition of patients suffering from motor disorders and to understand the impact of treatments and/ or rehabilitation therapies used on patients.

  • Page 24: Sit-To-Stand Tests

    4.2.3. Walk tests Gait Up GO includes three walking tests, the 2 minute walk test, the 10 meter walk test and a free walk test. For all three, the sensor is worn on one foot. Gait tests can be performed with all end users for which Gait Up GO is indicated.

  • Page 25: U Nningt Ests

    ● Tap Install (Note: “Gait Up GO” Mobile Application is free) ● Follow the onscreen instructions to complete the installation process ● Select and launch the Gait Up GO Mobile Application by tapping on the Gait Up GO logo on the Home Screen of the mobile phone/tablet device.

  • Page 26: D I Scovert He P H Ysilog

    NOTE: If you use Gait Up GO medical device for the first time, enable the Bluetooth connection from the Mobile Phone and/or Tablet options. NOTE: In order to enable updates, the mobile phone/tablet needs to be connected to the Internet by using WiFi or mobile data.
  • Page 27 (casing) where the Physilog6 sensor device and the clip accessories are contained. 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.

  • Page 28: First Use Of The Device

    Participant profiles, select tests for a Participant, buy credits and access reports. In order to use the Gait Up GO medical device, a medical professional is required to configure the mobile application for the Participant.
  • Page 29 NOTE: Using the “Purchase Physilog” button it is also possible to visit the Gait Up webshop in order to buy a Physilog6 sensor device. In order to be able to use the Gait Up GO medical device, it is necessary to have one Physilog6 sensor.

  • Page 30: N O Rmalu Se

    Enter the username and password (only for medical professionals) and select “Login”. NOTE: In order to be able to verify the login, the Gait Up GO mobile application needs to be connected to the internet via Wifi or mobile data.
  • Page 31 After submitting the new password, it is possible to connect to the Gait Up GO mobile application by using this newly defined password. The reset link is valid only once and for a limited period of time, after its expiration a new link must be requested by filling out the “forgot password”...

  • Page 32: Add New Participant

    From the dashboard it is possible to add new participants, search for a particular participant and select a profile from the list. The general settings can also be accessed from the Dashboard screen (see section 4.5.4 for information about the available settings). Fig 12.
  • Page 33 Please, refer to section 1. for device safety related information. NOTE: All participant data is locally stored on the mobile phone / tablet where the Gait Up GO mobile application is installed. The legal manufacturer and commercialising party do not have access to any participant information entered in the Gait Up GO mobile application.
  • Page 34 Find a Participant in the list When there are several Participant profiles saved in the Gait Up GO mobile application, it can become difficult to find a specific one by scrolling through the list. A “Search field” is available on the Dashboard screen to filter the list and make it easier to find a Participant.
  • Page 35 To change participants and/or register a new participant, go back to the dashboard and select an already existing profile or tap “Add Participant” (see section 4.5.3). Fig 24. How to go back to the dashboard - iOS Fig 25. How to go back to the dashboard - Android Edit a Participant To edit the selected participant’s information, tap on the pen icon(...
  • Page 36 Fig 27. How to edit a Participant profile and test(s) assigned - iOS Delete a Participant Deleting a Participant profile deletes all associated data such as Participant information, performed tests, generated reports and history reports. Because all data is saved locally on the mobile phone / tablet it is not possible to recover deleted data.
  • Page 37 Android 4.5.4. General settings Inside the password protected part of the Gait Up GO mobile application, the medical professional user can modify available settings. The General settings are available from the Dashboard screen. Fig 32. Settings button - iOS Fig 33.

  • Page 38: Go M O Bile A P Plication

    Internet by using WiFi or mobile data. For frequent users of Gait Up GO with a high amount of generated reports, it is possible to request an unlimited license from the Gait Up SA sales team. The unlimited license gives the medical professional users access to generating as many reports as desired for a fixed price during one year.
  • Page 39 Physilog6 sensor device’s firmware update. Using the “Purchase Physilog” button it is also possible to visit the Gait Up webshop in order to buy an additional Physilog6 sensor device. The ​ G ait Up GO medical device uses a single Physilog6 accessory device.
  • Page 40 NOTE: In order to change the password, the Gait Up GO Mobile Application needs to be connected to the Internet by using WiFi or mobile data.
  • Page 41 Physilog6 sensor connection status is displayed by the sensor icon ( ). The sensor icon is visible in the top right corner of the Gait Up GO mobile application on most screens. After opening, the Gait Up GO mobile application automatically connects to the Physilog6 sensor which is linked to the application by the user during first use.
  • Page 42 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 43: Go M O Bile A P Plication

    NOTE: If you use Gait Up GO on different mobile phones / tablets and have several Physilog6 sensor devices, it is recommended to control that the correct Physilog6 sensor device is linked to the Gait Up GO mobile application before starting the assessment session. Once the session is started, the linked Physilog6 can only be modified after login into the password protected part of the mobile application again.
  • Page 44 For those Participants who do not have access to the password protected part of the Gait Up GO mobile application, this is the initial screen that they will have access to.
  • Page 45 ● Check the linked Physilog6 by clicking on the button in the top right corner. Check that the indicated serial number is corresponding to the serial number of the Physilog6 which is handed to the participant. To change the linked Physilog6, go back to the Dashboard and open the “General settings” (see section 4.5.4).
  • Page 46 Figure 40 below. 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 41.
  • Page 47 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 or feedback contact the Gait Up support team at ​...
  • Page 48 The clip must not touch the participant’s skin, use the belt strap over the clothes if the subject is not wearing a belt. Carefully read the instructions given in the Gait Up GO Mobile Application for the selected test to know where to place the sensor.
  • Page 49 The Gait Up GO mobile application displays the instructions explaining how to perform the selected test. Please read the notes below before starting the test. NOTE: For each of the tests contained in the Gait Up GO mobile application it is important to not move before tapping “Go”.

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