ENGLISH D-2017-LBL-0086-AAF – Jan 2021
INSTRUCTIONS FOR USE GAIT UP GO ENGLISH 2/84
Legal manufacturer: Mindmaze SA Chemin de Roseneck, 5 1006 Lausanne Switzerland Contact email: info@mindmaze.com Website: www.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: contact@gaitup.com Website: https://clinical.gaitup.com/ Support email: support@gaitup.
TABLE OF CONTENT 3.3.2 VISUAL AND A UDITORY INDICATORS RELATED TO THE O PERATION OF T HE DEVICE 20 Instructions for Use 2 Gait Up GO 2 Physilog6 sensor device visual and auditory indicators 20 TABLE OF CONTENT 4 TABLE OF FIGURES 6 Gait Up GO mobile application visual indicators 21 INDEX OF TABLES 7 1. SAFETY INFORMATION 8 1.1. WARNINGS 1.1.1. WARNINGS RELATED TO THE OPERATING CONDITIONS O F T HE D EVICE 8 8 1.1.2.
Find a Participant in the list 34 5.1. CLEANING 63 Select a Participant 34 5.2. MAINTENANCE 63 Edit a Participant 35 64 Delete a Participant 36 5.3. STORING AND TRANSPORTING T HE DEVICE 4.5.4. GENERAL SETTINGS 37 Credits 38 Physilog 38 Account 40 Info 40 4.5.5. SENSOR INFORMATION AND UPDATE 4.5.6.
TABLE OF FIGURES Fig. 1 Fig. 2a Fig. 2b Fig. 3 Fig. 4 Fig. 5 Fig. 6 Fig. 7 Fig. 8 Fig. 9 Fig. 10a Fig. 10b Fig. 11 Fig. 12 Fig. 13 Fig. 14 Fig. 15 Fig. 16 Fig. 17 Fig. 18 Fig. 19 Fig. 20 Fig. 21 Fig. 22 Fig. 23 Fig. 24 Fig. 25 Fig. 26 Fig. 27 Fig. 28 Fig. 29 Fig. 30 Fig. 31 Fig. 32 Fig. 33 Fig. 34 Fig. 35 Fig. 36 Fig. 37 Fig. 38 Fig. 39 Fig. 40 Fig. 41 Fig.
INDEX OF TABLES Table 1. Definitions 12 Table 2. Gait Up GO components 15 Table 3. Physilog6 sensor components 18 Table 4. Automatic test end criteria 50 Table 5. List of report components and their description 60 Table 6. List of comparison report components and their description 62 Table 7. Troubleshooting 66 Table 8. Technical specifications 72 Table 9. Symbols 74 Table 10. EMI emissions 74 Table 11. Electromagnetic emissions 75 Table 12.
1. SAFETY INFORMATION The safety information is classified as follows: Warning! Clinical meaning: Refers to a hazard that, if not avoided, can result in serious injury or death General meaning: Advanced notice of something unpleasant or dangerous that will happen Caution! Refers to a potential hazard that, if not avoided, can result in minor personal injury and/or product/property damage Read the following safety information before using this medical device. 1.1. Warnings 1.1.1.
● ● ● ● ● ● 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. Do not introduce any pointy object in the hole present on the backside of the Physilog6 sensor device accessory.
1.2. Cautions ● Operate and configure Gait Up GO only if you are a qualified medical professional. You must be able to correctly place the Physilog6 sensor device, choose the suitable test for the Participant and interpret the output data offered by the reports generated by Gait Up GO mobile application. The Participants must use the Gait Up GO medical device only under your medical supervision and responsibility.
● ● ● ● Do not subject the Physilog 6 device accessory, containing batteries, to intentional or repetitive mechanical shocks; Do not leave the Physilog6 device accessory exposed directly to the sun. Store all Gait Up GO medical device accessories in the original Gait Up GO casing provided together with the device. Transport the Gait Up GO medical device, including all its accessories, within the original container case.
2. BEFORE USE Please, refer to section 1. Safety Information 2.1. Definitions Term Definition Participant Term used to describe the end users of the Gait Up Go medical device, including patients, healthy individuals and athletes. User Term used to describe any actor using the Gait Up Go medical device, including the medical professionals, end users and patient relatives.
● adult patients (any gender): 22 and older to help medical professional in getting objective parameters to: ● ● ● assess the condition of patients suffering from mobility disorders assess the risk of injury in athletes of all age and assess indicators of early-stage signs of diseases affecting motor function. 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.
2.5. Intended End user population 2.5.1. Patients suffering from motor disorders Patients only use the Gait Up GO medical device under the supervision of a medical professional, perform the tests and protocols set by the rehabilitation professional and use a device pre-configured by the medical professional at both, clinical and indoor home environments.
3. DESCRIPTION 3.1. Overview The Gait Up GO medical device components are delivered in a dedicated shipping box. Quantity Component Article number 1 Instructions for Use GOIFU 1 Instructions for Use Lay person GOIFUh 1 Quick start Guide GOQSG 1 Quick start Guide Lay person GOQSGh 1 Device case GOC 1 Physilog6 sensor device (*) P6 1 Belt clip and strap(*) BCS 1 Shoe clip(*) SC 1 USB cable(*) USBCc 1 Gait Up GO mobile application GO Table 2. Gait Up GO components.
3.2. Description of device components Fig 1. Gait Up GO device components Gait Up Go Mobile Application Fig 2a. Android application Fig 2b.
● ● ● ● generate clinical reports showing the main outcome indicators for the Medical Professionals to interpret it. manage Participant profiles and access generated reports update the Firmware of the Physilog6 sensor device accessory 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.
Component Function a) Body of the device It includes a moulded non-flammable ABS casing which embeds the electronics 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 circuitry.
Fixation clips and belt strap Made out of Acrylonitrile Butadiene Styrene (ABS) for medical applications, both the fixation clip for the belt (using the strap) and for the shoe are used to securely attach the Physilog6 sensor device to the Participant’s body. Fig 4.
3.3 User indicators 3.3.1 Visual user indicators related to battery charging 3.3.
Gait Up GO mobile application visual indicators 1. Information messages 2.
3.
4. USE 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: 1. the condition of patients suffering from motor disorders and to understand the impact of treatments and/ or rehabilitation therapies used on patients. risk of suffering an injury in professional athletes of any age. indicators of early-stage signs of diseases affecting motor function in Participants. 2. 3.
4.2. Included tests and their indications 4.2.1. Functional tests Jump tests Vertical jumps are commonly used to measure lower body power and indirectly assess an athlete's performance or to evaluate return to sports after an injury (ankle sprain or anterior cruciate ligament reconstruction). Gait Up GO includes two assessments of jumps: Two legged vertical Jump test (Sargent test) and single leg vertical Hop test.
The free gait test allows the therapist to perform his or her preferred walking protocol. Gait tests should be performed on flat ground. 4.2.4. Running tests The Gait Up GO application includes two running tests, the “Running strike profile” test where the sensor is worn on one foot is used to evaluate the runner profile. The “Running stiffness and impact” test uses the sensor at the belt and provides measurements of impact and stiffness which are useful to assess injury risk and fatigue.
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. NOTE: In order to login to the password protected part and generate reports, the Gait Up GO Mobile Application needs to be connected to the Internet by using WiFi or mobile data. 4.3.3. Discover the Physilog®6 sensor device Fig 5.
level of the Physilog6 sensor device on the Gait Up GO Mobile Application screen before starting any test (see section 4.5.5). ● ● ● ● Plug one end of the USB cable (USB-C end) into the Physilog6 sensor device USB-C port.
4.4 First use of the device 4.4.1 Login creation Select “Sign Up” and complete the registration (only for medical professionals). The account allows to access the password protected part of the application where the medical professional can set configurations, manage 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. Fig 6.
Fig 8. Physilog section after the first connection to the application - iOS/Android Check the serial number of the Physilog®6 sensor device on the device label located on the back of the sensor. Serial numbers have the following format: PHY-06-2020-01-NNNN Fig 9.
4.5. Normal use of the device 4.5.1. Login Open the Gait Up GO Mobile Application from the installed applications on the mobile phone / tablet. When no session is open, the login screen is displayed. The login allows the medical professional user to access the password protected part of the Gait Up GO mobile application where it is possible to set configurations, manage Participant profiles, select tests for a Participant, buy credits and access reports. To know how to sign up for an account, see section 4.
Fig 11. How to reset the password - iOS - Android After sending the password reset request, a message will be sent to your email. Inside the email, there is a link which allows you to open a webpage where a new password can be entered. After submitting the new password, it is possible to connect to the Gait Up GO mobile application by using this newly defined password.
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. Dashboard - iOS Fig 13. Dashboard - Android Add new participant To add a new participant, press the “plus” button in the right bottom corner. Fig 14. Add a participant from the dashboard -iOS Fig 15.
Fig 16. Add participant section - iOS Fig 17. Add participant section - Android Comments can be added to complete the participant profile, such as type of walking aid or pathology if the condition is not available in the list. The comment will be visible on the reports. The newly created profile is saved by clicking on « Save ». A text box will appear to confirm that the participant has been correctly saved in the dashboard list.
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. The search field filters the list according to the name indicated in the Participant profiles. The filter identifies all profiles which contain the entered search term in the Participant name.
-Start a “New session” (see section 4.5.6) -Check the “Reports” associated to this participant (see section 4.5.8) -“History” of this participant (see section 4.5.9) 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.
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. A Participant can be deleted from the Participant profile editing part of the application, by opening the third section called “Delete”.
Fig 29. How to delete a participant - Android It is also possible to delete a participant directly from the list of participants on the dashboard. To do so, slide the participant towards the left or right side of the screen and confirm the deletion. Fig 30. How to delete a participant from the dashboard- iOS Fig 31. How to delete a participant from the dashboard- Android 4.5.4.
The settings screen is composed by 4 screens, each one and the linked functionalities are explained below: Credits The Credits ( ) screen allows to: see, on the one hand, the current availability of credits and, on the other hand, purchase a new pack of credits or request an unlimited license. Fig 34. Credit section - iOS Fig 35. Credit section - Android Report credits are used to generate a report from a performed test. Each credit is giving access to one report.
Fig 36. Physilog section - iOS Fig 37. Physilog section - Android To change the linked Physilog6, check the serial number of your device on its backside (see Fig. 38 below). The serial number has the format PHY-06-2020-01-NNNN. Only the last four numbers (NNNN) need to be written in the serial number field appearing on the Mobile Application screen. Click on “ ” in order to pair the device. A pop up with a confirmation should appear after the device is paired.
A Participant must not wear more than one Physilog6 accessory on the body at the same time. Do not operate several Gait Up GO on the same Participant at the same time. Account The Account section ( ) allows to change the current password and gives the medical professional the possibility to select the unit system. Fig 39. Account section - iOS Fig 40.
Fig 41. Info section - iOS Fig 42. Info section - Android 4.5.5. Sensor information and update 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.
● Firmware version In case of problems with the sensor connection, refer to the troubleshooting section 7. If the issue persists, contact Gait Up support at support@gaitup.com 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.
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.
Fig 51. No direct access to results selected Fig 52. Direct access to results selected -If “Direct access to results” is activated (limited admin mode), it will be possible to spend credits and access a report directly after the end of a test. It is suggested to use this option when performing tests during sessions where the medical professional is present to simplify access to the result.
Fig 54. Activated reports appear in the participant’s tests - Android All assigned tests appear in the participant’s test list. After a test is performed and saved, the corresponding test will be marked as completed for the day. However, the same test can still be performed several times during the same day always following the recommendations given by the medical professional. Each day at midnight, the list of performed tests will be reset and all tests will again be shown as not done.
4.5.7. Operating a test Once the new session is started, the selected tests can be performed and the Gait Up GO mobile application can be operated either by a medical professional, by the Participant in presence of the medical professional or by the Participant or the patient relative at home without the presence of the medical professional. The result interpretation must however always be carried out by a medical professional.
Any of the tests displayed in the list of the participant for which the assessment session is open can be selected. Tests which were already performed during the same day are marked as completed but can be repeated. Fig 57. Vertical jump 1 leg test selection - iOS Android Fig 58. Vertical jump 1 leg test selection - After the test selection, the application is “Preparing the Physilog PHY6_NNNN”. If any issue is encountered in this part, check the troubleshooting section 6. Fig 59.
Fig 61. Possible sensor locations: back of the belt, foot, side of the belt The Physilog6 sensor device accessory is worn either at the belt or on a foot depending on the test. Therefore two fixation clips are provided with the sensor device: a belt and a shoelace clip. To fix the Physilog6 sensor device in the belt clip, place the Physilog6 on the belt clip. The sensor device can be clipped into the fixation clip in both directions.
Fig 63. Sensor fixation using the shoe lace clip Be careful not to pinch the skin of the Participant or your finger when fixing the sensor into the clip accessory and attaching the clip to the Participant. The clip accessories must not be in contact with the participant’s skin. When the sensor preparation is done and the participant is ready to start the test, select “Ready” and read the test instructions in the Gait Up GO mobile application. Fig. 64.
