FCC ID: 2AYHH-PHY06GAITUP Movement sensor

ENGLISH D-2017-LBL-0086-AAF Jan 2021 I NSTRUCTIONS FOR U SE G AIT U GO P 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.com ENGLISH 3/84 T ABLE OF C ONTENT Instructions for Use Gait Up GO 2 2 4 6 7 8 8 8 9 10 11 11 14 14 15 15 F C IGURES ONTENT T ABLE OF T OF ABLE I TABLES OF NDEX 1. S INFORMATION AFETY 1.1. W ARNINGS OPERATING 1.1.1. W RELATED ARNINGS THE TO THE DEVICE OF CONDITIONS AND 1.1.2. W CONDITIONS THE TO RELATED ARNINGS

USERS END THE OF AWARENESS 1.2. C 1.3. C DEVICE AUTIONS FOR ONTRAINDICATIONS 1.4. A REACTIONS DVERSE G AIT GO U P MEDICAL 2. B 12 12 2.2 I 2.4. I 2.3. I EFORE USE 2.1. D EFINITIONS USE NTENDED USE FOR NDICATIONS POPULATION NTENDED USER 2.4.1. P ATIENT RELATIVE P EDICAL ROFESSIONAL E POPULATION USER ND DISORDERS MOTOR FROM SUFFERING ATIENTS 2.4.2. M 2.5. I 13 13 13 14 12 12 NTENDED 2.5.1. P 14 2.6. E 2.5.2. H POPULATION EALTHY PERFORMANCE SSENTIAL 3. Description 3.1. O 3.2. D 3.3 U VERVIEW ESCRIPTION COMPONENTS DEVICE OF 20 SER INDICATORS BATTERY 3.3.1 V TO RELATED INDICATORS USER ISUAL 20 CHARGING 16 ENGLISH 3.3.2 V TO RELATED INDICATORS AUDITORY AND ISUAL 20 OPERATION DEVICE THE OF THE Physilog6 sensor device visual and auditory indicators 20 Gait Up GO mobile application visual 21 indicators 4. U SE 4.1. O 4.2. I VERVIEW AND NCLUDED INDICATIONS THEIR TESTS 4.2.1. F UNCTIONAL TESTS Jump tests 5 sit-to-stand tests 4.2.4. R 4.2.2. B 4.2.3. W TUG tests ALANCE TESTS TESTS ALK TESTS UNNING THE STARTING AND NSTALLING DEVICE G 4.3.1. I AIT THE LAUNCHING AND NSTALLATION OF U A GO M DEVICES NDROID ON PPLICATION OBILE P 25 A 4.3. I 4.3.2. I GO M 4.3.3. D 26 G LAUNCHING NSTALLATION OF AND OS A DEVICES PPLICATION I ON OBILE 6 P DEVICE SENSOR HYSILOG THE ISCOVER P U AIT 25 Charging of the Physilog6 sensor device THEIR AND COMPONENTS SYSTEM HECKING 4.4 F 4.5. N 4.3.4 C FUNCTIONALITY IRST DEVICE THE OF USE 4.4.1 L CREATION OGIN 4.4.2 P P AIRING A M PPLICATION OBILE DEVICE THE OF USE ORMAL 4.5.1. L OGIN PASSWORD ORGOT

/ E

/ S ELECT DD HYSILOG 4.5.2. F 4.5.3. A PROFILES Add new participant 6 THE TO G AIT GO U P 30 PARTICIPANT ELETE 31

/ D DIT 23 23 24 24 24 24 24 24 24 25 25 26 27 28 28 28 30 30 32 4/84 Find a Participant in the list Select a Participant Edit a Participant Delete a Participant SETTINGS ENERAL 4.5.4. G Credits Physilog Account Info 4.5.5. S 4.5.6. P UPDATE AND INFORMATION ENSOR REPARE SESSION ASSESSMENT AN Assign tests Limited admin mode Assessment session screen Preparing the device for Home use by 45 the participant 4.5.7. O TEST A PERATING Preparing the Participant Check Physilog6 sensor connection and battery level Select the test Sensor attachment Perform the clinical test End of the test with no direct access to the results 53 End of the test with Limited admin mode (direct access to the results) 53 TEST

, INTERPRET AND MANAGE ENERATE 4.5.8 G REPORTS Generate a report using Limited admin mode (direct access to the results) Generate and manage reports inside 55 the password protected part Delete a report Sharing a report Report interpretation 4.5.9. R COMPARISON EPORT 34 34 35 36 37 38 38 40 40 41 42 43 43 44 46 46 46 46 47 49 54 54 57 58 58 60 63 5.1. C 5.2. M 5.3. S 5.4. E LEANING AINTENANCE DEVICE THE TRANSPORTING AND TORING

. OPERATION FOR CONDITIONS NVIRONMENTAL 6. T ROUBLESHOOTING W THE OF RESET MANUAL A PERFORM TO HOW AND HEN 6 P SENSOR HYSILOG ACCESSORY DEVICE S C UPPORT USTOMER R EVENT ADVERSE AN EPORTING 7. W ARRANTY 8. D ISPOSAL Disposal of Gait Up GO medical device (incl. all its accessories) 9. T ECHNICAL 9.1. S 9.2. S PECIFICATIONS S PECIFICATIONS YMBOLS 9.3. EMI

EMISSIONS 9.4. G AND DECLARATION S MANUFACTURER UIDANCE E EMISSIONS LECTROMAGNETIC 9.5. G AND DECLARATION S MANUFACTURER UIDANCE E IMMUNITY LECTROMAGNETIC 9.6 Recommended separation distances between portable and mobile RF communications equipment bas the Gait Up GO medical device

9.7 FCC - Information to user FCC human exposure limits 9.8 Product Compliance - IC statement IC statement - English version IC human exposure limits - English version Dclaration IC - Version Franaise IC Exposition humaine - Version franaise 81 9.9 RF exposure compliance - Europe 63 63 64 64 65 66 67 67 68 68 69 70 70 72 74 74 75 78 79 80 80 80 81 81 82 83 84 Comparison report interpretation 61 5. C LEANING

, M AND AINTENANCE S TORAGE 10. A 11. L INDEX LPHABETICAL M ANUFACTURER EGAL ENGLISH 5/84 T ABLE OF F IGURES 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. 42 ENGLISH Fig. 43 Fig. 44 Fig. 45 Fig. 46 Fig. 47 Fig. 48 Fig. 49 Fig. 50 Fig. 51 Fig. 52 Fig. 53 Fig. 54 Fig. 55 Fig. 56 Fig. 57 Fig. 58 Fig. 59 Fig. 60 Fig. 61 Fig. 62 Fig. 63 Fig. 64 Fig. 65 Fig. 66 Fig. 67 Fig. 68 Fig. 69 Fig. 70 Fig. 71 Fig. 72 Fig. 73 Fig. 74 Fig. 75 Fig. 76 Fig. 77 Fig. 78 Fig. 79 Fig. 80 Fig. 81 Fig. 82 Fig. 83 Fig. 84 Fig. 85 Fig. 86 16 16 16 17 19 26 28 28 29 29 30 30 31 32 32 32 32 33 33 33 33 34 34 34 34 35 35 35 36 36 37 37 37 37 37 38 38 39 39 39 40 40 41 41 41 41 41 42 43 43 43 43 44 44 44 45 46 46 47 47 47 47 48 48 49 49 50 51 51 51 52 52 52 53 53 53 55 55 56 56 57 57 58 58 59 61 61 62 6/84 I NDEX OF TABLES 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. Troubleshooting Table 8. Technical specifications Table 9. Symbols Table 10. EMI emissions Table 11. Electromagnetic emissions Table 12. Electromagnetic immunity 12 15 18 50 60 62 66 72 74 74 75 77 ENGLISH 7/84 1. S AFETY 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 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. Caution!

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. Gait Up GO sensor device accessory, Physilog6 sensor, should be handled carefully. In particular, it should not receive intentional shocks, such as fall, crushing, being hit, etc. Do not use or charge the Physilog6 if the sensor, its case or USB cable are damaged. Contact Gait Up about what further action is needed when any component is damaged. Do not attempt to repair or modify the device or replace any of its components. For repair, maintenance and replacements, please refer to Gait Up SA customer support. Damaged parts must be immediately replaced with original parts by the customer service. Do not use any external power supply (mobile phone charger) other than those compatible with the technical specifications listed in section 9 of the present document. Always refer to the device manual for proper charging instructions. Use of accessories and cables other than those specified or provided by the manufacturer of this medical device could result in improper operation of the device. Always refer to the manufacturer indications. Do not operate Gait Up GO medical device in an MRI room 8/84 ENGLISH Operate the Gait Up GO medical device at ambient room conditions in terms of temperature

(0C - 30C), 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. On the internal face of the hole, a membrane that ensures the IP64 protection index of the sensor device is placed. By damaging it, the protection is no longer ensured and water ingress can damage the electronics and battery housed in the enclosure of the Physilog6. Be aware that there is no reset button behind such hole in the device. Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in improper operation. If such use is necessary, this equipment and the other equipment should be observed to verify that they are operating normally. Use of accessories, transducers and cables other than those specified or provided by the manufacturer of this equipment could result in increased electromagnetic emissions or decreased electromagnetic immunity of this equipment and result in improper operation. Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of the [ME EQUIPMENT or ME SYSTEM], including cables specified by the manufacturer. Otherwise, degradation of the performance of this equipment could result. 1.1.2. Warnings related to the conditions and awareness of the end-users Before using the Gait Up GO medical device, evaluate the conditions of the Participant (see definition in section 2.1) and the appropriateness of using such a medical device. The Participants must be conscious, capable to understand and follow the instructions and able to actively participate in the session (i.e. follow the instructions shown in the screen of the mobile phone where the Gait Up GO mobile application is installed while performing the different tests) Before using Gait Up GO medical device, instruct the Participants in the safe use of the device. Uttermost caution should be exercised when using the device in Participants with the suspected or diagnosed heart problem like ventricular arrhythmia, heart insufficiency following risk factors:

or hemodynamic instability;

Visual/auditive problems the Instructions For Use. DO NOT use the Gait Up GO in other parts of the Participant body but in the ones indicated in DO NOT manipulate or remove Gait Up Go accessories from the user body during the session. Accurate results are only guaranteed if the Physilog6 sensor accessory is firmly attached on the user shoe or belt and the Instructions for Use are followed during the duration of the assessment. When using the Gait Up GO wearable accessories (Physilog6 sensor device and its clip accessories) on different Participants, disinfect the applied parts in potential contact with the skin of the Participant before using it on another Participant, as there is the risk of spreading infections. Keep device away from pets 9/84 ENGLISH 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. Precaution should be exercised when using the device in following conditions:

Do not use Gait Up GO medical device in case of software malfunctioning, including mobile phone application, repeated Bluetooth Low Energy (BLE) connection issues, and repeated reset of the Physilog6 sensor device accessory. In all those cases, the customer support must be contacted. Gait Up GO medical device uses a single Physilog6 sensor device accessory. A Participant must not wear more than one Physilog6 accessory on the body at the same time. Do not operate several Gait Up GO medical devices on the same Participant at the same time. Do not combine the equipment of the Gait Up GO with the equipment or the applied parts of other devices/accessories. Always refer to the manufacturer indications;

Do not operate the device and contact the customer support with the error message given by the Gait Up GO Mobile Application if the Physilog6 sensor device accessory fails to perform the firmware update. Do not operate Gait Up GO medical device if the Physilog6 sensor device accessory is not correctly placed on the end-users body 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. Liquids and foreign material (e.g. dust) must not be allowed to enter the Physilog6 sensor device accessory. Do not clean the device with excessive liquid. For cleaning and maintenance instructions, refer to the section 5 of the present document. ENGLISH 10/84 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. Mindmaze SA is not liable for transport damage if the Gait Up GO medical device is not packed in its original container case. 1.3. Contraindications for Gait Up GO medical device Do not use the Gait Up GO medical device, version 1.0, on Participants:

in combination with active implantable medical devices and/or electromedical devices that have direct impact on the health condition of the patient;

in combination or in close proximity to any life supporting medical device;

in direct contact with open wounds, pressure sores, inflammation or skin irritated area;

Electromagnetic Hypersensitivity syndrome: Idiopathic Environmental Intolerance to Electromagnetic Fields. The consequences of the performance of the tests included in the Gait Up GO medical device by pregnant women is unknown. Therefore, it is not recommended the use of Gait Up GO medical device on pregnant women. 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. ENGLISH 11/84 2. B EFORE USE Please, refer to section 1. Safety Information 2.1. Definitions Term Participant User BLE IFU eIFU QSG eQSG Table 1. Definitions 2.2 Intended use Definition Term used to describe the end users of the Gait Up Go medical device, including patients, healthy individuals and athletes. Term used to describe any actor using the Gait Up Go medical device, including the medical professionals, end users and patient relatives. Bluetooth low energy (or Bluetooth smart) Instructions for use Quick start guide Electronic version of the Instructions for use Electronic version of the Quick start guide Gait Up GO is a medical device intended to help therapists, physicians, medical doctors and rehabilitation specialists to assess the condition of patients suffering from motor disorders. 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). Gait Up GO is further used to measure indicators of early-stage signs of diseases affecting motor function (such as Parkinson Disease). The device can be used at hospitals, clinics, rehabilitation centers and patient's home. 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) ENGLISH 12/84 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. GaitUp GO is a Px only (under prescription) Medical Device. The users of Gait Up GO medical device are patient relatives, medical professionals, patients and healthy individuals. 2.4. Intended user population 2.4.1. Patient relative The role of the patient relative is to help the patient, while using the device at home, with attaching, starting, stopping, removing and charging the device if the patient is not able to perform them her/himself (f.ex. young child). Prevalent age: +20 years old. Prevalent physical condition: No specific physical conditions are needed. Minimum education level: none Minimum knowledge required: Understand user manual, be able to use a smartphone or tablet application Minimum experience: be able to place the sensor correctly on the end user's body according to the graphical illustration contained in the instructions 2.4.2. Medical Professional Medical professionals set-up the Gait Up GO medical device in a suitable environment, choose the appropriate tests and program the medical device for a specific Participant following its condition. Moreover, they are in charge of interpreting the data contained in the reports generated by the medical device. For those activities, the medical professionals use all the components of the Gait Up GO medical device. Only medical professionals (i.e qualified physiotherapists, occupational therapists, etc.) must use Gait Up GO by fully complying with their respective countrys regulations and accident prevention measures, and strictly following the instructions for use of the device. Minimum education level: nurse, physiotherapist, occupational therapist, ergotherapist, assistant therapist Minimum knowledge required: Understand user manual. Therapist degree: knowledge of clinical protocols. Be able to use a smartphone or tablet application Minimum experience: The medical professional should be able to choose meaningful and safe protocols for the Participant and be able to place the sensor correctly on the end user's body according to the graphical illustrations shown in the user interface of the mobile application. 13/84 ENGLISH 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. Prevalent age: 2 -99+

Prevalent physical condition: suffers from movement disorder or disability Minimum education level: none Minimum knowledge required: understand instructions Minimum experience for proper product usage: no minimum experience required. 2.5.2. Healthy population Healthy population can use the device in order to assess injury risk for prevention in athletes (f.ex young football players) or to measure indicators of early-stage signs of diseases affecting motor function (f.ex. Parkinson Disease). Healthy population only use Gait Up GO medical device under the supervision of a medical professional and use a pre-configured device by the medical professional and perform the tests and protocols set by the respective medical professional at both, clinical and indoor home environments. Prevalent age: 2 -99+

Prevalent physical condition: no specific physical conditions are needed. Minimum education level: none 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 60601-1:2005+AMD1:2012 CSV. IEC ENGLISH 14/84 3. D ESCRIPTION 3.1. Overview The Gait Up GO medical device components are delivered in a dedicated shipping box. Quantity Component Article number Instructions for Use GOIFU Instructions for Use Lay person GOIFUh Quick start Guide GOQSG Quick start Guide Lay person GOQSGh Device case GOC Physilog6 sensor device (*) P6 Belt clip and strap(*) Shoe clip(*) USB cable(*) BCS SC USBCc Gait Up GO mobile application GO Table 2. Gait Up GO components. (*) are accessories. The related technical specifications are provided in section 9 of the present document. WARNING: Do not use any external power supply (mobile phone charger) other than those compatible with the technical specifications listed in section 9 of the present document. Always refer to the device manual for proper charging instructions. Note1: Check the shipping box content for any missing component and for any damage that may have occurred during transportation. Note 2: It is highly recommended to keep the Gait Up GO medical device components in the original device case when it is not used, positioned in the corresponding slots as they were delivered originally. 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:

Gait Up GO Application is freely available for installation on Google Play Store and Apple App The minimum system specifications for a phone or a tablet to be used with Gait Up GO medical device are provided in section 9 of the present document. 15/84 1 1 1 1 1 1 1 1 1 1 Store ENGLISH 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 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 receive, process and analyse the raw data sensed by the Physilog6 sensor device 16/84 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. The Gait Up GO Mobile application provides guidance to the users on how and where to place the Physilog6 sensor device on the Participants body (see section 4 for further details) Physilog6 sensor device Fig 3. Physilog 6 sensor Physilog 6 sensor device is an accessory of the Gait Up GO medical device intended to measure human movement parameters such as acceleration, orientation and angular velocity, barometric pressure and direction, strength and relative change of a magnetic field. The Physilog6 sensor device is operated via the Gait Up GO mobile application to perform the following actions:

Connect the sensor device to the phone/tablet via BLE Stream raw data of human movement to the Gait Up GO mobile application Disconnect the sensor device from the phone/tablet via BLE The Physilog6 sensor device has a function called shake up to wake up. After 30 seconds of no activity (i.e. sensor device not moving and not connected to the Mobile Application), the 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:

ENGLISH 17/84 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 transmits a microcontroller with a wireless communication unit 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. The sensor device is powered by an internal LIB battery (lithium-ion battery), which is IEC 62133:2012 certified. The Physilog6 sensor device is water and dustproof according to the standard IP64. that b) LED It emits light indicating the different status of the sensor device;

Charging Charged Errors:

Blinking white Shining green Blinking red:

Recording Warnings:

Blinking green Blinking yellow Not enough battery to start a recording Cannot start a recording Error during a recording Hardware part broken Battery starting to be low during recording c) Button The button serves to perform a reset of the device in case it is not responding normally. See section 6. Troubleshooting for more information. d) USB-C plug It allows the users and end-users to plug the USB cable included in the device packaging on the one end to the Physilog6 sensor device and on the other end either to a compatible mobile phone charger (see specifications on section 9 of the present document) for charging purposes. to a computer or e) Mechanical connector for the fixation clips Mechanical design feature included in the Physilog6 casing and used to fit mechanically the fixation clips into the body of the Physilog6 sensor device. The feature is symmetrically present on both extremities of the Physilog6 casing. Table 3. Physilog6 sensor components ENGLISH 18/84 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 Participants body. Fig 4. Fixation clip accessories USB cable Device case 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. Primary packaging in which the Gait Up GO medical device components are delivered. The device components should be kept in this original packaging when not used, positioned in the correspondent slots as they were delivered originally. ENGLISH 19/84 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 Gait Up GO mobile application visual indicators 1. Information messages 2. Error messages ENGLISH 21/84 3. Confirmation messages ENGLISH 22/84 4. U SE 4.1. Overview Please, refer to section 1. Safety Information. Gait Up GO medical device enables the recording and analysis of some protocolarized motion tests to assist in the assessment of:

1. 2. 3. 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. A number of tests are contained in the Gait Up GO Mobile Application, categorised as:

Functional tests Jump tests 5 sit-to-stand test Timed up and GO (TUG) tests Balance tests Walk tests Running tests Inside each category of tests, there are specific tests contained. As an example two-legged balance test is a test contained inside the Balance tests category. The Medical Professional evaluates the condition of the Participant, especially in consideration of the warnings and cautions. Then, the Medical Professional choses in the Gait Up GO Mobile Application the test or set of tests for the Participant to perform. The Medical Professional places the Physilog6 sensor accessory on the Participants body following the indications provided by the Mobile Application. The Participant attempts to perform the indicated movements by the screen of the Mobile Application. The Participant performs the test under the supervision of a Medical Professional Once the Participant has finalized the test, the Medical Professional generates a Test Report directly from the Mobile Application. The data shown in the test report is to be interpreted by the Medical Professional. The Medical Professional can prescribe the Participant to perform a test or a set of tests at home. The Participant will have access to a restricted mode of the Mobile Application, where just the prescribed tests can be accessed. Under some circumstances, the Medical Professional can allow the Participant to generate Test Reports. However, the interpretation of those results must always be done by the Medical Professional. ENGLISH 23/84 4.2. Included tests and their indications 4.2.1. Functional tests Jump tests 5 sit-to-stand tests TUG tests 4.2.2. Balance tests 4.2.3. Walk 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. For the jump tests the sensor is worn at the belt and the test subject is asked to jump vertically with either both legs or one leg at a time. To obtain repeatable results, the test should be performed in the same way (use of arms). The five times sit to stand test is used to assess lower extremity strength, translational movements, balance and risk of fall. It is commonly used for elderly people and patients with Parkinson, having suffered a stroke or with vestibular disorders. To obtain repeatable results, the same chair should be used. The Physilog6 sensor is worn at the belt. TUG Timed Up and Go test (

) is a simple test used to assess a person's mobility and evaluates both The static and dynamic balance. It is used to determine risk of fall and measure the progress of balance, sit to stand and walking. The TUG is used frequently in the elderly population or in populations with a GO device includes two TUG tests, one standard and one for double-task reduced mobility. The Gait Up To obtain repeatable results, the same chair TUG. For the TUG tests, the sensor is worn at the belt. should be used. The static balance assessment allows to evaluate the risk of falling. It can be used with all end users for which Gait Up GO is indicated. Gait Up GO includes six different balance tests: two-legged balance test, single leg balance test, one-legged balance comparison test, tandem test, semi-tandem test and Romberg test. Balance tests do not require any additional equipment. The Physilog6 sensor is worn at the belt. 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. The 2 minute walk test is a measure of self-paced walking ability and endurance. It has been shown to yield results that are concurrent with the 6 minute walk test and has the advantage of being shorter. The 10 meter walk test is a performance measure used to assess walking speed which can be used to assess functional mobility and gait. For the 10 meter walk test requires a path which allows to walk in a straight line for 10 meters. ENGLISH 24/84 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. The runnings test allows the therapist to perform his or her preferred protocol for healthy or injured runners. Running tests can be performed on a treadmill or on flat ground. 4.3. Installing and starting the device The Gait Up GO application can be downloaded for Apple and Android mobile phones and tablets. No mobile phone or tablet is delivered with the product. The mobile device must meet the requirements described in section 9 under mobile specifications. 4.3.1. Installation and launching of the Gait Up GO Mobile Application on Android devices Open the Google Play Store Search for Gait Up GO Select Gait Up GO Mobile Application 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. 4.3.2. Installation and launching of Gait Up GO Mobile Application on iOS devices Open the App Store Search for Gait Up GO Select Gait Up GO Mobile Application 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. ENGLISH 25/84 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. In order to login to the password protected part and generate reports, the Gait Up GO Mobile NOTE:

Application needs to be connected to the Internet by using WiFi or mobile data. 4.3.3. Discover the Physilog6 sensor device Fig 5. Physilog6 sensor device inside its packaging Open the packaging delivered together with the Gait Up GO medical device Take the Physilog6 sensor device and the USB cable out from the packaging Connect the USB cable (USB-C side) to the Physilog6 sensor device Connect the USB-A part of the USB cable to a computer or to a mobile phone charger compatible with the specifications listed in section 9 of the present document Make sure that the Physilog6 sensor device is fully charged (when battery charging is complete, the LED on the Physilog6 sensor device body will shine green) When the charging is complete, the device is ready to be used. Charging of the Physilog6 sensor device The Physilog6 sensor device is a wearable sensor powered by a Lithium-Ion rechargeable battery. It is not possible to recharge the battery during the device operation. That is why, please check the battery ENGLISH 26/84 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. Plug the USB-A end of the UCB cable into a computer or a mobile phone charger with specifications compatible to the ones listed under section 9 of the present document, During charging, the LED on the Physilog6 sensor device emits a blinking white light, even when the sensor device is not connected to the Mobile Application. When the charging is complete, the LED on the Physilog6 sensor device will shine green and the battery level shown in the Gait Up GO Mobile Application will appear as full. It is important to charge the Physilog6 sensor device for at least 4 hours before an assessment session is started. Note: It is recommended to charge the Physilog6 sensor device at the end of each session. Note: Use only the USB cable provided by the manufacturer. Note: Use only mobile phone chargers with specifications compatible to the ones provided by the manufacturer in section 9 of the present document. Note: Please, in order to keep the performance of the device, recharge the battery of the device every 3 months if it is stored and not used 4.3.4 Checking system components and their functionality Visually inspect all the components of Gait Up GO medical device (Mobile phone/tablet, Physilog6 sensor device, clip accessories and USB cable) for signs of damage, especially in correspondence of connectors, primary packaging (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. Clean the Physilog6 sensor device and the clip accessories before using the device. See section 5. Cleaning, Maintenance and Storage of the present document. Make sure that the Mobile Phone/Tablet is fully charged before starting an assessment session. Make sure that the Physilog6 sensor device is fully charged before starting an assessment session. Do not operate the device while the Physilog6 sensor device is being charged. Open the Gait Up GO Mobile Application and connect it to the relevant Physilog 6 sensor device. Check that there are no connection issues. Refer to the section 4.4.2 of the present document for more information. Position the sensor device into the clip accessories and check that the Physilog6 sensor device is firmly attached to the clip. Note: In case of BLE connection issues, please contact the customer support. 27/84 ENGLISH 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. How to register in the application - iOS Fig 7. How to register in the application -

Android 4.4.2 Pairing Physilog 6 to the Gait Up GO Mobile Application The Gait Up GO mobile application requires to be connected to a Physilog6 sensor device accessory which is worn by the Participant and collects the data during the tests. The sensor to which the mobile application connects, needs to be set once at the beginning of the use. For all next uses with the same mobile phone / tablet and Physilog6 sensor device, the connection is automatically done. After you login for the first time, the following screen will be displayed:

ENGLISH 28/84 Fig 8. Physilog section after the first connection to the application - iOS/Android Check the serial number of the Physilog6 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. Physilog label with the serial number surrounded by blue and the four unique numbers to enter in the Gait Up GO mobile application surrounded by red In the text field appearing on the Mobile Application screen, introduce the last four numbers (NNNN), then click on Link in order to pair the device. A pop up with a confirmation should appear after the device is paired. NOTE: the Bluetooth of the mobile phone / tablet needs to be activated. For mobile devices/tablets operating with Android OS, the localisation must in addition be activated to be able to use Bluetooth low energy. The Gait Up GO application does not access your localisation information. 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: 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. ENGLISH 29/84 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 4.4.1. To login with your account, follow the steps mentioned below:

Fig 10a. Login page - iOS Fig 10b. Login page - Android 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. 4.5.2. Forgot password If you cannot remember the password you set in your previously created account, it is possible to reset it by selecting Forgot your password and following the instructions below. ENGLISH 30/84 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. 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 form inside the Gait Up GO mobile application again. In order to reset the password, the Gait Up GO Mobile Application needs to be connected to the NOTE:

Internet by using WiFi or mobile data. 4.5.3. Add / Select / Edit / Delete participant profiles All the data, user data and reports are stored locally. If the phone memory is reset all information in the application will be deleted permanently. The Gait Up GO application only saves the data in the phone memory, the Gait Up GO application does not save / upload any Participant data on a server. The phone is not meant to serve as permanent storage for Participant data, the data must be transferred to the Medical Professional's computer. Uninstalling the Gait Up GO mobile application deletes all data permanently. Do not clear the cache and data related to the Gait Up GO mobile application, as this will also delete all collected data permanently. Inside the password protected part of the Gait Up GO mobile application which is reserved for medical professionals, it is possible to manage the Participant profiles. The Dashboard displays the list of available profiles including the name of the Participant, amount of reports generated and tests performed with the profile and the date of the last performed test. It shows the currently available amount of credits at the bottom of the screen. ENGLISH 31/84 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 To add a new participant, press the plus button in the right bottom corner. Add new participant Fig 14. Add a participant from the dashboard

-iOS Fig 15. Add a participant from the dashboard

-Android The participant profile consists of the following information: name, gender, birth year, size, weight, health condition, walking aid needs and history of falling. For the health condition several pathologies are available for selection, for all conditions which are not specified, other can be used. According to the participant profile, the normative data on the reports is adapted. ENGLISH 32/84 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. NOTE: Please be aware of the Participant conditions which present risk factors for using Gait Up GO. 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. After saving, the new participant will appear in the Dashboard. Fig 18. New participant saved - iOS Fig 19. New participant saved -Android ENGLISH 33/84 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. Fig 20. Find a participant in the list - Android Fig 21. Find a participant in the list - iOS Select a Participant To select a Participant, click on the corresponding name in the list on the Dashboard screen. When a participant is selected from the Dashboard, the participant profile will appear on the screen. The profile includes all the information previously introduced. Fig 22. Participant profile - iOS Fig 23. Participant profile - Android In the participant profile screen the following options can be selected:

ENGLISH 34/84

-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. How to go back to the dashboard - Android Edit a Participant

). The Participant edition screen To edit the selected participants information, tap on the pen icon(

is composed of three sections, the first section allows to modify the participant profile information. The second section allows assigning tests to the participant. It is the responsibility of the medical professional to select the appropriate tests for each Participant. The last section is for deleting a Participant profile (see next subsection). Fig 26. How to edit a Participant profile and the test(s) assigned - Android ENGLISH 35/84 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. On iOS clicking on this tab will automatically ask for a deletion confirmation whereas on Android it is necessary to press on the trash button (

) in this section. Fig 28. How to delete a participant - iOS ENGLISH 36/84 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. 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. Settings button - Android ENGLISH 37/84 The settings screen is composed by 4 screens, each one and the linked functionalities are explained below:

Credits The Credits (

other hand, purchase a new pack of credits or request an unlimited license.

) screen allows to: see, on the one hand, the current availability of credits and, on the 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. Credits are bought via Google Play Store (Android) or App Store (iOS) from inside the Gait Up GO mobile application. Once the purchase has been successfully completed, the credits will be available immediately. Credits are available in different pack options:

Small pack 20 credits Medium pack 200 credits XL pack 1000 credits (on iOS only). In order to be able to purchase credits, the Gait Up GO Mobile Application needs to be NOTE:

connected to the 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. Unlimited licenses cannot be purchased from the app. Under the option request unlimited license on the Credits screen, the request is submitted directly to the Gait Up SA Sales team. Physilog The Physilog section is used to link the Physilog6 sensor device to the Gait Up GO Mobile Application. The linked Physilog6 is saved for all logins of the Gait Up GO mobile application on the same phone. This means if the phone is used with two medical professional accounts, the linked Physilog6 is the same for both of them. ENGLISH 38/84 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. NOTE: Both devices can only be paired if the Bluetooth of the Mobile Phone/Tablet is enabled. 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). Fig 38. Physilog label with the serial number surrounded by blue and the four unique numbers to enter in the Gait Up GO mobile application surrounded by red If the Physilog6 sensor devices firmware is not up to date, the Physilog screen shows the Update Physilog button below the image of the sensor. See section 4.5.5 below to know more about the Physilog6 sensor devices 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 Gait Up GO medical device uses a single Physilog6 accessory device. ENGLISH 39/84 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. The Account section (

the possibility to select the unit system.

) allows to change the current password and gives the medical professional Account Fig 39. Account section - iOS Fig 40. Account section - Android In order to change the password, it is necessary to enter the current password, then write the new password and confirm it by writing it a second time. The password change is applied immediately after pressing the Change password button. The password is associated with the medical professional user account, applying to all mobile devices/tablets in which the respective user account is used. In order to change the password, the Gait Up GO Mobile Application needs to be connected to NOTE:

the Internet by using WiFi or mobile data. In addition it is possible to select the preferred unit system between metric and imperial units. All data collected before changing the unit system will be converted to the selected units. Info ENGLISH The information screen (

) displays all information about the Gait Up GO medical device, legal manufacturer, designer, regulatory labelling and version of the Gait Up GO mobile application. It also provides a direct link to the Help/FAQ webpage and the medical device eIFU and eQSG. 40/84 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 top right corner of the Gait Up GO mobile application on most screens.

). The sensor icon is visible in 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. In order to perform a test, the sensor needs to be connected to the Gait Up GO mobile application. ENGLISH Fig 43.Physilog connected Fig 44. Physilog not connected Fig 45. Physilog information/update When the sensor is connected, it is possible to access some information about the Physilog6 sensor device:

Physilog status (connected - trying to connect - charging) Battery level percentage 41/84 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. 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. To update the sensor, press the Update Physilog button in the sensor information window or go to the Physilog screen (

) in the

) of the Gait Up GO mobile application and press the Update Physilog button General settings (

(login required). Fig 46. Update Physilog - iOS - Android After pressing Update Physilog, the Physilog sensor will be updated automatically. The Gait Up GO mobile application displays the progress of the updating process. Do not close the Gait Up GO mobile application or inactivate the Bluetooth of the mobile phone/tablet during the update of the sensor. NOTE: In order to enable updates, the mobile phone/tablet needs to be connected to the Internet by using WiFi or mobile data. The Gait Up GO device only works with the Physilog6 sensor which is medical-grade and certified as an accessory for Gait Up GO. In case you have purchased a different version of Physilog (commercial grade version) the customer service at

. support@gaitup.com from Gait Up SA device portfolio, please contact 4.5.6. Prepare an assessment session From the dashboard, select the Participant for which an assessment session should be started and click on New session as shown on the picture below. ENGLISH 42/84 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. To check the linked Physilog6, click on the button in the top right corner (

) and check that the indicated serial number is corresponding to the serial number of your Physilog6. To change the linked Physilog6, go back to the Dashboard and open the General settings (see section 4.5.4). Fig 47. How to start an assessment - iOS Fig 48. How to start an assessment - Android Assign tests By selecting New session the Assign tests section will appear. This section allows to activate or inactivate the tests that the subject can perform during the next session. NOTE: It is the responsibility of the medical professional to select safe and appropriate tests for each participant and their condition. Fig 49. Assign tests - iOS Fig 50. Assign tests - Android Limited admin mode While preparing the new session, the Medical Professional can select if the direct access to results is allowed or not. ENGLISH 43/84 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. If the Participant is meant to use the medical device without the physical presence of the medical professional, it is recommended to disable this option. However, under certain circumstances, the medical professional may want the Participant to be able to generate reports on his/her own. In this case, the option "Direct access to results" should be enabled. The use of the device must always be supervised by a medical professional. The interpretation of such reports must always be done by a medical professional. Be aware that the Participant will be allowed to spend credits from your account if Direct access to results is activated. This option is called limited admin mode because it gives the user access to some functionalities usually reserved for the medical professionals.

-If No direct access to results is written, it will not be possible to spend credits and access a report directly after the completion of a test. The results will be locally saved and the report can be generated later by the medical professional. Assessment session screen After pressing the Start button, the Gait Up GO mobile application enters an assessment session. The assessment session is associated with the Participant profile from which the session was started and allows to perform the tests assigned by the medical professional to this participant. 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. ENGLISH Fig 53. Activated tests appear in the participants test list - iOS 44/84 Fig 54. Activated reports appear in the participants tests - Android All assigned tests appear in the participants 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. Preparing the device for Home use by the participant The participant can use the device at home to perform assessments in between therapy sessions or to have regular data points during long-term treatments. It is the medical professionals responsibility to configure the Gait Up GO medical device according to the capabilities and safety requirements for each Participant. Before handing the device to the participant for home use, the medical professional should perform the following steps:

Install the Gait Up GO mobile application on the mobile phone/tablet which the participant will take home and login with your medical professional account. Configure the Gait Up mobile application for the participant. (see sections 4.3 to 4.5.6) 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). Check selected tests

: Verify that the tests selected for the participant are adapted for home use without your presence. Especially evaluate for each test if the participant can perform the test safely. It is recommended to only assign tests which the participant has already performed in your presence. (see section Assign tests) Check if direct access to reports is active or not

: for home use it is recommended to inactivate direct access to reports. This allows the medical professional to keep control of the credits and to avoid misinterpretation of the results by the Participant due to the absence of the interpretation by the medical professional. (see section Limited Admin mode) Start the Session for the Participant who will use the device at home. When the Participant will open the Gait Up GO mobile application, the assessment session screen will be displayed. Inform the Participant (or the patient relative) about the frequency of performing the tests

(f.ex. once every day or week) and how to take care of the Physilog6 sensor accessory. Provide the Participant (or patient relative, when applicable) the mobile phone/tablet, Physilog6 and instructions for use and Quick start Guide for Lay person. ENGLISH 45/84 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. Preparing the Participant Before attaching the sensor device accessory to the Participant, please check the integrity of the skin in the area where the sensor will be placed. In case of redness or skin damage, do not fix the sensor on the Participant. Make sure that the participant is wearing adequate shoes where the clip can be attached firmly and without heels. Check Physilog6 sensor connection and battery level Check that the Physilog6 is connected to the Gait Up GO mobile application and that it has a sufficient battery level. Check the sensor status by accessing the sensor information from the button in the top right corner as shown in 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. NOTE: the Bluetooth of the mobile phone / tablet needs to be activated. For Android the localisation must in addition be activated to be able to use Bluetooth low energy. The Gait Up GO application does not access your localisation information. 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 case of any issue with Physilog6 connection, check the troubleshooting section 6. If problems persist, contact the Gait Up SA support team at

. support@gaitup.com Fig 55. Physilog linked Fig 56. Physilog information Select the test ENGLISH 46/84 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 Fig 58. Vertical jump 1 leg test selection -

Android 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. Sensor preparation before the test - iOS Fig 60. Sensor preparation before the test - Android Sensor attachment 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

. support@gaitup.com ENGLISH 47/84 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. You need to clip the fixation connector on the upper part of the fixation clip first, then push the lower half of the Physilog6 sensor device until you hear a clicking sound. Once the sensor is attached to the fixation clip, it is possible to place the clip at the belt of the test subject. The clip must not touch the participants 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. Fig 62. Sensor fixation using the belt clip To fix the Physilog6 sensor device on the foot, use the shoe lace clip. Insert the clip without the sensor device under the shoe laces. Take two rows of laces when possible to have better attachment. Then place the Physilog6 sensor device on the clip. You need to clip the fixation connector on the upper part of the fixation clip first, then push the lower half of the Physilog6 sensor device until you hear a clicking sound. The sensor can be placed on the shoe without restrictions of orientation and position. ENGLISH 48/84 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 participants 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. Read instructions Perform the clinical test 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. NOTE: Some tests are performed in several steps. In this case, a new instruction screen will appear together with an explanation of the next step. Tap Go to start the next part of the test. ENGLISH 49/84

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. Fig. 65. Complementary instructions Test type Stop automatically after:

Monopodal balance comparison 30 seconds (x 2) One leg balance Balance on two legs Semi-tandem balance Tandem balance Romberg test 30 seconds 30 seconds 30 seconds 30 seconds 30 seconds (x 2) Sit to stand transfer 5 sit to stand detected Vertical jump 1 leg 1 jump detected (x 2) Vertical jump 2 legs 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 When the participant has understood the instructions and is ready to perform the test, press Go, In that moment, the Participant can start to perform the movement explained in the instructions shown in the user interface of the application. Fig. 66. Instruction and test start - iOS 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). 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. Fig. 68. Recording ongoing If the test has been successfully performed, a green check mark will appear on the screen, together with the name of the test. Any comment about the performance of the test (f.ex. pain at the left hip) can be optionally added. This comment will be displayed on the test report. Tap Save to register the results and be able to generate a report. ENGLISH 51/84 Fig. 69. Screen after completing a test - iOS Fig. 70. Screen after completing a test - Android The user can delete the test result in case of any problem happening with the execution of the instructions provided by the mobile application or if the test had to be interrupted by any cause. In this case, the performed test data is deleted and no report can be generated later. NOTE: Data analysis problems can arise due to a bad quality movement or recording. In those 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 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. Fig. 71 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. ENGLISH 52/84 End of the test with no direct access to the results During the test assignment it is possible to select Direct access to results or No direct access to results Please refer to the Assign test section to check how to activate or inactivate this setting. Fig. 72. Direct access to results option If the direct access to the report results is inactivated, a message will pop up informing that the test results have been saved. The report can be unlocked later by the medical professional. Fig. 73. Test has been saved - iOS Fig. 74. Test has been 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 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 is activated, the User will be able to spend credits and access the reports immediately at the end of the test after clicking Save. A confirmation request will be generated for the user to confirm the spending of one credit to generate and display the report (see section 4.5.8 for more information). ENGLISH 53/84 After closing the report, The Gait Up GO mobile application displays the session screen from where the user can select another test from the list. In order to generate reports, the Gait Up GO Mobile Application needs to be connected to the NOTE:

Internet by using WiFi or mobile data. 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. For each credit, one report can be generated. For frequent users it is possible to purchase an unlimited license which allows to generate as many reports as wanted for a yearly flat rate fee. The unlimited license is linked to the Physilog6 serial number which allows a group of users who are using the same Physilog6 but with distinct login accounts to benefit from the unlimited number of reports. There are two ways to generate and display reports:

Limited admin mode - Direct access to results is activated: the user can spend credits and display the test report directly after performing and saving a test. This direct access needs to be activated by the medical professional before starting a new session (see section 4.5.6 - Limited Admin mode). Generated reports must always be analysed and interpreted by a medical professional. Inside password protected space - Direct access to results inactivated by the medical 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 Gait Up GO mobile application. This must always be done by the medical professional. The two modes respond to different use scenarios. The unlimited admin mode with direct access to results is useful during therapy sessions where the medical professional is using the device to assess a Participant and wants to see the report immediately after the test. For the home use case where the Participant is using the device without physical presence of the medical professional, the inactivation of direct access to the result allows the medical professional to control the spending of credits from his account. In addition, it ensures that the Participant is not confronted to the results without the presence of a medical professional who can interpret and explain the outcomes to the Participant. Generate a report using Limited admin mode (direct access to the results) If the Direct access to results is activated, the participant will be able to spend credits and access the reports immediately at the end of the test after clicking Save. After saving the test result, a confirmation request is displayed. If Confirm is selected, the report will be unlocked by using one credit and it will be displayed inside the Gait Up GO mobile application. NOTE: for tests performed with a Physilog6 sensor accessory linked to an unlimited license, the report will automatically be displayed after clicking Save, if the direct access to reports is activated. ENGLISH 54/84 Fig. 75. Confirmation request - iOS In order to generate reports, the Gait Up GO Mobile Application needs to be connected to the NOTE:

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). Generate and manage reports inside the password protected 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 part of the Gait Up GO mobile application. Go to the login screen by pressing the Login or back button. The medical professional logs in with his/her account used to start the assessment session. Then the participant for which a report should be displayed can be selected from the Dashboard and the associated test results opened by clicking on Reports. ENGLISH 55/84 Fig. 77. How to access the report in the password protected part - iOS Fig. 78. How to access the report in the password protected part - Android The reports are ordered according to their date with the most recent at the top. Newly performed tests for which the report has not yet been generated appear with a lock sign. To generate the report, select the report from the list. A confirmation message allows 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. In order to generate reports, the Gait Up GO Mobile Application needs to be connected to the NOTE:

Internet by using WiFi or mobile data. NOTE: A report which was unlocked once stays unlocked for the future, each report needs to be paid for only once and can be displayed as many times as wished. The report list can be filtered according to the test name using the search bar like on the Dashboard screen. ENGLISH 56/84 It is highly recommended to save the results to the patient folder and/or the medical professionals computer. The data collected using Gait Up GO is locally stored on the mobile phone / tablet and the loss or damage of said mobile device implies that the results are no longer accessible. Delete a report It is possible to delete reports from the list of reports available for a given Participant. 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 recovered and will no longer appear in report comparisons (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. Fig. 79. How to delete a report - iOS Fig. 80. How to delete a report - Android ENGLISH 57/84 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. 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 via email or bluetooth. Fig. 81. How to share a report - iOS Fig. 82. How to share a report - Android Report interpretation Each test provides a given set of result parameters which are presented in a test report. ENGLISH 58/84 Fig. 83. Test report example and its components Report component Description a) Test name Name of the performed test b) Test date Date and time when the test was performed c) Participant information Summary of participant information including:

Name Birth year Height and weight 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 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 ENGLISH 59/84 position of the result on the colorbar. The units of the result value are also indicated. g) Normative threshold value For some result parameters, specific values are highlighted by a triangle below the colored bar. These are threshold values which indicate interesting reference points such as the average of the population of the same age or physiological reference values. h) Colorbar based on literature normative values All result parameters are displayed with respect to normative data from scientific literature. Where the color is red means that the achieved result is poor compared to Participants of similar age and health condition (if literature is available). 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. Table 5. List of report components and their description The report can be exported by pressing the text or pdf icon on the top right hand corner. This allows for example to send the report directly to an electronic patient folder or share the result via email. 4.5.9. Report comparison The History button accessible from the participant profile screen allows to open the report comparison view of the Gait Up GO mobile application. For each test assigned to a specific Participant for which at least two reports have been generated, a comparison of the results is possible. The history is available when several reports of the same test have been generated for the same Participant. This feature allows the Healthcare Professional to have and visualise factual data about the progression of the Participant over the time. It is possible to export history reports into pdf or text format for sharing and sending it to a computer or electronic patient record file. ENGLISH 60/84 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 Fig. 86. Comparison report example and its components Report component Description a) Test name Name of the performed test b) Participant information Summary of participant information including:

Name Gender Birth year Height c) Parameter name Name of the result parameter with its icon d) Result values e) Test dates For each report generated for this test and participant, the test result value of the parameter is displayed. A line is drawn between values in order to visualize the evolution of the test result. For each test result value the date at which the test has been performed is shown. The order of displayed results is chronological with the most recent on the right side. Table 6. List of comparison report components and their description ENGLISH 62/84 5. C LEANING

, M AINTENANCE AND S TORAGE Please, refer to section 1 Safety Information. Both, the Physilog6 sensor device and the clip accessories can be manually cleaned and disinfected carefully using wipes with different chemicals (available at drugstore or pharmacy) detailed under section 5.1 of the present document. 5.1. Cleaning Clean and disinfect the Physilog6 sensor device and the clip accessories before the first use at home as follows:

Unpair the Physilog6 sensor device from the Mobile Application by closing the Gait Up GO mobile application prior to cleaning Unclick the Physilog6 sensor device from the clip accessories prior to cleaning Unplug the Physilog6 sensor device from the USB cable/power prior to cleaning Use Hydrogen peroxide 3%, bleach solution 50% or saline solution to clean and disinfect the Physilog6 sensor devices clip accessories. Do not use a cleaning spray, but carefully wipe it using a humid wipe. Use 96% ethanol solution or 70% isopropyl solution to clean and disinfect the physilog6 sensor devices 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 allowed to enter the Physilog6 accessory device. Do not clean the device with excessive liquid. Ensure that the Physilog6 sensor device and the clip accessories are dry prior to being used again. 5.2. Maintenance The Gait Up GO medical device is tested and calibrated prior to distribution. Under normal conditions, the characteristics of the device do not vary. The Physilog6 should be handled carefully. 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. Physilog6 The according to the instructions of use section 4.5.5. firmware is updated using the Gait Up GO mobile application provided by Gait Up SA The Physilog6 sensor device does not include any consumables (one-time use). The fixation clips used to fix the Physilog6 sensor device on the Participants body are spare parts. If they get damaged, please contact Gait Up SA support to purchase new ones. ENGLISH 63/84 5.3. Storing and transporting the device Do not store the Physilog6 sensor device connected to the USB cable. Unclip the Physilog6 sensor device from the shoelace clip accessory before storing it. Place all components within the original packaging, each of them in its dedicated space inside Store it in a cool (-20 - +60C) and dry place at a stable temperature and ambient humidity the casing.

(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:

The Gait Up GO medical device must be stored in accordance with the following conditions:

The Gait Up GO medical device must be transported in accordance with the following conditions:

Temperature: [0-30] C Humidity: [10-70]%

Pressure: [600-1070] hPA Temperature: [-20-+60]C Humidity: [25-70]%

Pressure: [600-1070] hPA Temperature: [-20-60]C Humidity: [25-70]%

Pressure: [600-1070] hPA ENGLISH 64/84 Problem What to do More Information 6. T ROUBLESHOOTING What do you see/hear The Gait Up GO mobile application displays an error pop-up after you select a test, indicating that it cannot connect to the Physilog6 sensor device There is a problem with the connection to the Physilog6 sensor device The Physilog6 sensor device accessory has incompatible firmware version. The Gait Up GO mobile application displays an error pop-up after you select a test, indicating that the sensor device accessory has incompatible firmware Make sure that the sensor device accessory is in proximity of your mobile device. Control that the sensor device accessory has enough battery to be connected to the application. Click on the sensor

) information button (

to check that the linked sensor device accessory corresponds to the sensor in your possession (last four digits of serial number on the back of the sensor corresponding to the number indicated in the mobile application). Update the sensor device firmware by pressing the

"Update Physilog"

button. Before handing a Gait Up GO device to a Participant for 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 accessory is managed inside the password protected part of the application to which the end user does not have access. This error can appear during the first use after you update the Gait Up GO mobile device or after installation of the application on a new mobile device. The Gait Up GO mobile application There is a problem with the Physilog6 The recording is interrupted, acknowledge the error Depending on the problem, the error message will display a recommendation ENGLISH 65/84 indicates an error pop-up during a recording sensor device accessory message inside the Gait Up GO mobile application and follow the recommendation in the error message. to the user. It can be for example that the sensor device accessory does 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 device accessory will perform a reset without your intervention and a new recording can be started. The Gait Up GO mobile application can trigger a reset of the sensor device accessory without your intervention if it detects a problem. During recording, the sensor device accessory normally blinks green. If the battery gets low, the blinking turns orange. The Physilog6 sensor device accessory emits a beep sound and briefly blinks red and orange The Physilog6 sensor device accessory has performed a reset The Physilog6 sensor device accessory is blinking yellow during the recording The battery of the sensor device accessory is getting low Table 7. Troubleshooting Nothing needs to be done, the sensor device accessory just solved its issue on its own. Complete the test, then recharge the sensor device accessory 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. Unplug Physilog6 if it is charging. Press the sensor button for 15 seconds, it will blink orange and beep. Release the button and wait until the blinking stops. ENGLISH 66/84 Customer Support The customer support is provided by:

Gait Up SA EPFL Innovation Park Btiment C CH-1015 Lausanne Switzerland Phone: +41 21 633 7527 (office hours: 8h30 to 17h30 CET, Monday to Friday) General contact email:

Email:

support@gaitup.com contact@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 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). ENGLISH 67/84 7. W ARRANTY 30 Days Return Policy:

If you are not satisfied with any Gait Up product that you have purchased directly from Gait Up you can return the product within 30 days following the date of shipment by Gait Up. If the item is returned unused, undamaged, and in its original condition we will exchange it or offer a refund of the purchase price paid. All returned products must be packed in the original packaging including any accessories, manuals, documentation, and registration that shipped with the product. Damage and missing part restocking fees may apply. Shipping and handling charges, as well as taxes paid (e.g., state, customs, VAT) are not refundable. You are responsible for and must prepay all shipping charges and you shall assume all risk of loss or damage to the product while in transit to Gait Up. 24 Months Limited Warranty:

Gait Up warrants all products sold or offered directly by Gait Up against defects in materials and workmanship under normal use for a period of 24 months from the date of retail purchase by the original purchaser (Warranty Period). Under this warranty, if a defect arises and a valid claim is received by Gait Up within the Warranty Period, at its option and to the extent permitted by law, Gait Up will either (1) repair the product at no charge, using new or refurbished replacement parts or (2) exchange the product with a new or refurbished product. A replacement product or part assumes the remaining warranty of the original product. To obtain warranty service, you must deliver the product at your expense, to the 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 product will be uninterrupted or error-free and is not responsible for damage arising from failure to follow instructions relating to proper usage of the product. This warranty does not apply to a product or part of a product that has been altered or modified. In addition, this warranty does not apply: (a) to damage caused by use with non-Gait Up products; (b) to damage caused by accident, abuse, misuse, flood, fire, earthquake or other external causes; (c) to damage caused by operating the product outside of the permitted or intended uses described by Gait Up or with improper voltage or power supply; or (d) to damage caused by service (including upgrades and expansions) performed by anyone who is not a representative of Gait Up. Recovery and reinstallation of software programs and user data are not covered under this warranty. Occasionally Gait Up engages in more interactive support or consulting. Interactive support is at customer courtesy and is provided at Gait Ups discretion. It does not invalidate the support policy described above. There is no guarantee of performance, timeliness, or establishment of a continuous support relationship. Consulting is subject to acceptance of a formal statement of work. Warranty and Support conditions may change without prior notice. Please refer to the Sales terms and conditions on Gait Ups website. 8. D ISPOSAL ENGLISH 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). 68/84 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. 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 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. ENGLISH 69/84 Regulatory Classification MDD: Class I medical device according to Rule 12 of Annex IX 93/42/EEC 9. T ECHNICAL S PECIFICATIONS 9.1. Specifications Gait Up GO medical device Size Weight Physilog6 sensor device: 0.015 kg Physilog6 sensor device: 43 x 33 x 15 mm Fixation accessories:

shoe lace clip: 50 x 26 x 13 mm belt clip: 64 x 27 x 21 mm USB cable: length 50cm Fixation accessories:

shoe lace clip: 0.03 kg belt clip: 0.08 kg USB cable: 0.02 kg Applied parts materials Physilog6 sensor device casing:

acrylonitrile butadiene styrene (ABS) copolymer POLYLAC PA-765 - Flame retardant Power source Power plug Battery life User indicators Communications Clip accessories:

Styrene (ABS) for medical applications. USP grade IV. CYCOLAC RESIN HMG94MD. Acrylonitrile Butadiene USB cable: PVC USB-C Internally powered. Rechargeable battery. Lithium- Ion rechargeable battery 3.7V nominal. Number of recharging cycles > 500 cycles Gait Up GO mobile application: User Interface Physilog6 sensor device: LED and beeper Bluetooth Low Frequency (BLE). frequency band: 2.402-2.480 GHz

(TX & RX) Effective radiated power (max): 11.11 dBm Environmental conditions

(use-transport-storage) Use:

Temperature:[0-30] C Humidity:[10-70]%

Pressure: [600-1070] hPA Storage:

Temperature:[-20- +60]C ENGLISH 70/84 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%

CE-marked & ROHS compliant USB-A connection Bluetooth 4.0 or higher with BLE frequency of 128Hz or higher Minimum screen size 4,7 inch Minimum screen resolution 750x1334 Android (7.0 or higher) and iOS (11.0.0 or higher)

> 3 hours Mobile Phone CISPR 32 compliant RoHS compliant Wi-FI connectivity Bluetooth wireless communication OS Battery life Tablet CISPR 32 compliant RoHS compliant Wi-FI connectivity Bluetooth wireless communication Yes Yes Yes Yes Yes Yes Bluetooth 4.0 or higher Minimum screen size 8 inch Minimum screen resolution 1200x1920 ENGLISH 71/84 OS 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 Caution Logo Warning Logo Do not send the device or any of its accessories to a standard garbage ENGLISH 72/84 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 Lithium battery handling label Device under prescription logo Table 9. Symbols 9.3. EMI emissions System Characteristics Function Frequency (mHz) Max. antenna gain (dBi) Max. E.I.R.P (dBm) Max E.I.R.P (mW) Table 10. EMI emissions Max. declared output power (dBm) Description Recording 2402-2480 8 1 11.11 12.91 9.4. Guidance and manufacturers declaration - Electromagnetic emissions The Gait Up GO medical device has been developed for electromagnetic compatibility according to 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 an environment. Emissions test Compliance Electromagnetic environment - guidance RF emissions CISPR 11 Group 1 Gait Up GO medical device is a medical electrical equipment which uses RF energy only for its internal function. Therefore, its RF emissions are ENGLISH 74/84 very low and are not likely to cause any interference in nearby electronic equipment. 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 emissions IEC 61000-3-3 Table 11. Electromagnetic emissions N/A N/A N/A N/A 9.5. Guidance and manufacturers declaration - Electromagnetic immunity Immunity test IEC 60601 test level Compliance level 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 Electromagnetic environment guidance Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity 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) USB cable must be the one provided by the manufacturer Electrical fast transients/burst IEC 61000-4-4 Supply: 2 kV Supply: 2 kV I/O lines : 1 kV I/O lines : 1 kV Frequency : 100 kHz Frequency : 100 kHz N/A (DC supply with cable < 3m) Surges ENGLISH 75/84 IEC 61000-4-5 Voltage dips, short interruptions and voltage variations on power supply lines IEC 61000-4-11 N/A (DC supply) Frequency (50/60 Hz) magnetic field IEC 61000-4-8 30 A/m, 50 or 60 Hz tested in X, Y and Z axes. 30 A/m, 50 or 60 Hz Radiated RF immunity IEC 61000-4-3 10 V/m @

80MHz-2.7GHz 80% AM 1kHz 10 V/m @

80MHz-2.7GHz 80% AM 1kHz ENGLISH Power frequency magnetic fields should be at levels characteristic of a typical commercial or hospital environment. Portable and mobile RF communications equipment should be used no closer to any part of the Physilog6 sensor device, including the USB cable, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter Minimum separation distance shall be calculated by following equation:

E= (6/D)*sqrt(P) Where:

E is the immunity test level in V/m P is the maximum output power rating of the transmitter in watts (W) according to the transmitter 76/84 manufacturer and 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

(b) Interference may occur in 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 Conformity level

(V/m) Level

(V/m) 27 28 28 28 Modulation pulse: 18 Hz Modulation pulse: 18 Hz 710 745 - 780 Modulation 9 pulse 217 Hz 810 870 - 930 Modulation 28 pulse: 18 Hz 1720 1845 -

1970 Modulation pulse 217 Hz Modulation pulse 217 Hz 385 450 2450 27 28 9 28 28 28 ENGLISH 77/84 5240 5500 -

5785 Modulation pulse 217 Hz 9 9 Conducted RF immunity IEC 61000-4-6 3 V 0,15 MHz 80 MHz 6 V in ISM bands, between 0,15 MHz and 80 MHz 80 % AM @ 1 kHz 3 V 0,15 MHz 80 MHz 6 V in ISM bands, between 0,15 MHz and 80 MHz 80 % AM @ 1 kHz in If the measured field strength the location in which the Physilog 6 is used exceeds the applicable RF compliance level, the Physilog 6 should be observed to verify normal operation. If abnormal is performance additional observed, be measures may as necessary, such or reorienting relocating the Physilog 6

. Table 12. Electromagnetic immunity Note (a) Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To access the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the device is used exceeds the applicable 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. Note (b) Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3V/m 9.6 Recommended separation distances between portable and mobile RF communications equipment bas the Gait Up GO medical device 78/84 ENGLISH 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 0.1W 1W 10W 100W 0.06 0.19 0.6 1.90 6 0.2 0.63 2 6.32 20 0.06 0.19 0.6 1.90 6 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 to the transmitter manufacturer. ENGLISH

*The ISM (industrial, scientific and medical) bands between 150 kHz and 80 MHz are 6.765-6.795 MHz, 13.553-13.567 MHz, 26.957-27.283 MHz and 40.66-40.7 MHz.

**Formulas coming from the IEC 60601-1-2 9.7 FCC - Information to user

, cautions the user This document, which describes the instructions for use for an intentional that changes or modifications not expressly approved by the Manufacturer could void the user's authority to operate the equipment. radiator 54 FR 17714

, Apr. 25, 1989, as amended at 68 FR 68545

, Dec. 9, 2003]

This device complies with Part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) this device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation. 79/84

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. However, there is no guarantee that interference will not occur in a particular installation. If this equipment does cause harmful interference to radio or television reception which can be determined by turning the equipment off and on, the user is encouraged to try to correct interference by one or more of the following measures:

Reorient or relocate the receiving antenna. Increase the separation between the equipment and receiver. Connect the equipment into an outlet on circuit different from that to which the receiver is connected. Consult the dealer or an experienced radio/TV technician for help. FCC human exposure limits This device complies with FCC radiation 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 not expressly approved by the party responsible for compliance could void the user's authority to operate the equipment. Note: The separation distance between the user and/or bystander and the antenna and/or radiating element of the device is of at least 20mm. 9.8 Product Compliance - IC statement IC statement - English version Under Industry Canada regulations, this radio transmitter may only operate using an antenna of a type and maximum (or lesser) gain approved for the transmitter by Industry Canada. To reduce potential radio interference to other users, the antenna type and its gain should be so chosen that the equivalent isotropically radiated power (e.i.r.p.) is not more than that necessary for successful communication. This device complies with Industry Canada licence-exempt RSS standard(s). Operation is subject to the following two conditions: (1) this device may not cause interference, and (2) this device must accept any interference, including interference that may cause undesired operation of the device. This device complies with Industry Canada radiation exposure limits set forth for general ENGLISH 80/84 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 Canadas licence-exempt RSS(s). Operation is subject to the following two conditions:

This device may not cause interference. This device must accept any interference, including interference that may cause undesired operation of the device. IC human exposure limits - English version This device complies with ISED radiation exposure limits set forth for general population. This device must not be co-located or operating in conjunction with any other antenna or transmitter. Note: The separation distance between the user and/or bystander and the antenna and/or radiating element of the device is of at least 20mm. Dclaration IC - Version Franaise Conformment la rglementation d'Industrie Canada, le prsent metteur radio peut fonctionner avec une antenne d'un type et d'un gain maximal (ou infrieur) approuv pour l'metteur par Industrie Canada. Dans le but de rduire les risques de brouillage radiolectrique l'intention des autres utilisateurs, il faut choisir le type d'antenne et son gain de sorte que la puissance isotrope rayonne quivalente (p.i.r.e.) ne dpasse pas l'intensit ncessaire l'tablissement d'une communication satisfaisante. Le prsent appareil est conforme aux CNR d'Industrie Canada applicables aux appareils radio exempts de licence. L'exploitation est autorise aux deux conditions suivantes : (1) l'appareil ne doit pas produire de brouillage, et (2) l'utilisateur de l'appareil doit accepter tout brouillage radiolectrique subi, mme si le brouillage est susceptible d'en compromettre le fonctionnement. Le prsent appareil est conforme aux niveaux limites dexigences dexposition RF pour la population globale dfinies par Industrie Canada. Lappareil ne doit pas tre install proximit ou tre utilis en conjonction avec une autre antenne ou un autre metteur. Lmetteur/rcepteur exempt de licence contenu dans le prsent appareil est conforme aux CNR dInnovation, Sciences et Dveloppement conomique Canada applicables aux appareils radio exempts de licence. Lexploitation est autorise aux deux conditions suivantes :

Lappareil ne doit pas produire de brouillage;

Lappareil doit accepter tout brouillage radiolectrique subi, mme si susceptible den compromettre le fonctionnement. le brouillage est ENGLISH 81/84 IC Exposition humaine - Version franaise Le prsent appareil est conforme aux niveaux limites d'exigences d'exposition RF aux personnes dfinies par ISDE. Lappareil ne doit pas tre install proximit ou tre utilis en conjonction avec une autre antenne ou un autre metteur. Note : La distance de sparation entre l'utilisateur et/ou le spectateur et l'antenne et/ou l'lment rayonnant de l'appareil est d'au moins 20 mm. 9.9 RF exposure compliance - Europe Maximum RF Output power (11.11 (13mW) peak EIRP at Cmid, Tmax) of the equipment is under 20mW, and then test result is compliant without additional measurement. So, EN 62311 (2008) low power /

inherent compliance decision is applied ENGLISH 82/84 10. A INDEX LPHABETICAL ENGLISH 83/84 11. L EGAL M ANUFACTURER Mindmaze SA Chemin de Roseneck, 5 1006 Lausanne Switzerland Email:

info@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 contact Mail:

Support Mail:

Web:

support@gaitup.com contact@gaitup.com www.gaitup.com ENGLISH 84/84

Gait Up SA EPFL Innovation Park, Bat C. CH-1015 Lausanne www.gaitup.com TVA CHE-145.136.760 User manual Thank you for purchasing Physilog 6S, the Swiss quality movement sensor. This manual introduces how to use the different features of the sensor. ENGLISH D-PHY6S-LBL-0102 / Physilog 6S - Instructions for use 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 CH-1015 Lausanne Switzerland EPFL Innovation Park, Batiment C General Contact email:

contact@gaitup.com Website:

https://clinical.gaitup.com/

Support email:

support@gaitup.com Model:

Physilog 6S IC ID: 26802-PHY06GAITUP FCC ID:

2AYHH-PHY06GAITUP Physilog 6S user manual v1.2.0 Date: 26.01.2021 Copyright 2021, All Rights Reserved - Gait Up SA. CH-1015 Switzerland www.gaitup.com 2 Control the Physilog from a mobile application How to update Date and Time of the Physilog 6S How to update firmware of Physilog 6S with nRF Connect Table of Contents Physilog 6S elements Charging Recording with Physilog 6S Standalone measurement Data Analysis Practical Considerations Fixation Tips for best practices Maintenance and Disposal Sensor specifications Troubleshoot Limited Warranty & Support Policy Product compliance Europe FCC IC - Canada (EN) IC - Canada (FR) Contact information 4 4 5 5 6 6 6 6 7 7 9 10 12 13 14 15 16 16 16 17 18 Physilog 6S user manual v1.2.0 Date: 26.01.2021 Copyright 2021, All Rights Reserved - Gait Up SA. CH-1015 Switzerland www.gaitup.com 3 1. Physilog 6S elements 2. Charging The Physilog 6S is charged via the USB-C port. Plug the USB-C connector of the cable delivered with the Physilog 6S to the sensor. Plug the USB connector to a Computer or charger (see voltage specifications below). Physilog 6S recording must be stopped for charging. Do not charge Physilog when room temperature is outside of range 0C to 45C. Low battery level is indicated by yellow blinking during measurement or if the Physilog blinks rapidly 3 times red when starting and doesn't start the recording (see LED indications below). A battery level estimation is available via the Gait Up mobile applications. When the Physilog is discharged, plug it for charging for at least 30 minutes before use. It is recommended to avoid complete discharging of the Physilog 6S, therefore check that the Physilog sensors are off when you store them. After a long period without using the Physilog, plug it for charging for at least 30 minutes before use. It may happen that the LED doesn't blink white at the beginning of charging after the battery was very low, to see the charging ongoing shortly push the main button or disconnect and reconnect after some charging time. Physilog 6S user manual v1.2.0 Date: 26.01.2021 Copyright 2021, All Rights Reserved - Gait Up SA. CH-1015 Switzerland www.gaitup.com 4 Supply Voltage specifications The Physilog 6S should be charged using USB at 5V, 100mA. For charging, the ambient temperature must lie between 0C and 30C. Power supply: 5V DC, 50/60Hz, 100mA 3. Recording with Physilog 6S There are several ways to start and stop a measurement with the Physilog 6S:

3.1. Standalone measurement Press on the main button (for about 2 secs, until the green light turns off) to start the measurement. During measurement, the Physilog shines green. Hold the main button for 3 seconds, until the light turns orange to stop the measurement. When the measurement has been concluded, the LED shortly blinks green three times. If several Physilog 6S sensors are configured to do so and started at the same time, they synchronize regularly during the measurement. A network includes one single master sensor and several slave sensors (from one to as many as wished). Multiple sensor networks can be created by selecting a different radio channel. The network configuration is done via the Research ToolKit Desktop software (see RTK user manual for details) and is saved in the conf.bin file on each Physilog 6S. To perform a measurement with synchronized Physilog 6S, turn on all sensors of the network with the main button within a short interval of time (all must be started within one minute). No precise order of starting the sensors is necessary. Each sensor starts recording data from start and once it is synchronized with the master sensor it will shine green synchronously with the master sensor. To stop the measurement, push the main button of the sensors until the LED turns orange, you can turn off the sensors in any order. Physilog 6S user manual v1.2.0 Date: 26.01.2021 Copyright 2021, All Rights Reserved - Gait Up SA. CH-1015 Switzerland www.gaitup.com 5 3.2. Control the Physilog from a mobile application The Gait Up companion mobile applications allow to control the Physilog 6S sensor. Two modes are available in the application, for details refer to the user manual of the mobile application. There is no need to pair your Physilog with the tablet prior to Bluetooth communication, just select the Physilog from the list in the app. Troubleshoot: If a sensor is not detected by the tablet, gently shake the sensor to enter detection mode. If the sensor can still not be connected, check that it has enough battery and is not connected to another mobile device and if necessary ultimately do a reset of the sensor as explained in section 5.7 Troubleshoot. Note:

Bluetooth 4.0 or higher is required on the mobile device to be able to communicate with Physilog 6S. 4. Data Analysis Physilog always saves raw data on its internal memory, except when streaming the data live via Bluetooth using the IMU stream functionality of the app. Users have access to the raw data through companion software called Research ToolKit (RTK). The RTK is available for computers

(PC and Mac). Functions to read raw data inside MATLAB are also available. Please refer to the RTK user manual for more details. USB data transfer Data saved on the internal memory of the Physilog can be accessed using USB data transfer. Therefore, plug the USB cable to the Physilog and a computer. The Physilog 6S connects to the computer like a USB key and files can be accessed. One file for each measurement is created and files are stored in folders depending on creation date (YY_MM_DD). The file name is composed of a file number (increasing from 1 to 99), the body location (as defined in the configuration, f.ex.

'LF') and the sensor serial number unique part (4 digits). Copy-paste the files to your computer for analysis. From here you can also rename folders and files or delete the files from Physilog's memory. Warning: Do not remove the conf.bin file which contains the configuration information, otherwise the Physilog will return to a default configuration. If this happens, update the configuration using the Research ToolKit or contact Gait Up support. 5. Practical Considerations 5.1. Fixation The Physilog 6S comes with two fixation clips as default attachment accessory, one for the belt and one for the shoe laces. Additional clips and elastic straps with Velcro patches to stick onto the Physilog can be purchased from Gait Up. Physilog 6S user manual v1.2.0 Date: 26.01.2021 Copyright 2021, All Rights Reserved - Gait Up SA. CH-1015 Switzerland www.gaitup.com 6 5.2. How to update Date and Time of the Physilog 6S Via computer:

Create a new text file on the Desktop of your computer or directly on the Physilog sensor

(on Windows: right click, new>text file, on Mac: open text editor and save file as text file) Leave it empty and rename it to TIME (complete name with file extension: TIME.txt) Copy-paste the file to the Physilog if you saved it on the Desktop Disconnect the Physilog from the computer to update the time and date to the hour when the file has been created Create a new text file each time you update the date, do not just rename or modify an existing TIME.txt file (TIME.txt file previously created will update to the date it was created, so in the past). The TIME.txt file will disappear from Physilog's memory when disconnecting the Physilog from the computer, therefore it is normal to not find it the next time you open the Physilog on the computer. Via mobile application:

Connect the Physilog to the Android companion application inside the Remote control mode. Start a short measurement from the app, you can stop the measurement as soon as the stop button is available in the user interface of the mobile application. Then disconnect the sensors or completely quit the app. 5.3. How to update firmware of Physilog 6S with nRF Connect The firmware is updated via Bluetooth. Therefore, install the nRF application on a mobile or tablet (Android or iOS) and follow the steps below. It may be necessary to install a file manager application in addition to the nRF app to be able to select the firmware file from a chosen location of file storage on your device. Android Install the nRF Connect for Mobile app on the Android device Download the latest firmware version from the email to the Android device Open the nRF Connect app and enable all necessary permissions Go to Scanner tab and scan for surrounding Physilog (gently shake the

(Bluetooth and Position, see pictures below) Physilog 6S to enter detection mode) Select connect of one Physilog 6S sensor in the list Plug the selected Physilog to a power source to be sure to have enough battery to perform the update Physilog 6S user manual v1.2.0 Date: 26.01.2021 Copyright 2021, All Rights Reserved - Gait Up SA. CH-1015 Switzerland www.gaitup.com 7 In the top right corner of the app click on the DFU button (on the right of Disconnect) and select Distribution Packet (ZIP) from the proposed options Get the new firmware file from where it was downloaded Wait until the graph in the app has shown that 100% of the firmware was transferred, this may take some minutes Disconnect the Physilog by clicking on Disconnect and close the tab of the Physilog 6S Plug the Physilog to the computer and update the date and time (see above) above) list iOS Plug the Physilog to the computer and update the date and time (see Install the nRF Toolbox on the iOS device Download the latest firmware version from the email to the iOS device Add the downloaded firmware to nRF Toolbox by connecting the iOS device to the computer:

Open iTunes and select your phone Select the Apps tab on the left and scroll down Under File Sharing select the nRF Toolbox app and add the Firmware file to the Documents Physilog 6S user manual v1.2.0 Date: 26.01.2021 Copyright 2021, All Rights Reserved - Gait Up SA. CH-1015 Switzerland www.gaitup.com 8 app earlier the update minutes Click on Done and disconnect phone from computer Open the nRF Connect app on the iOS device and enable Bluetooth Open DFU option of the app Click on Select File and go to the tab user files where you find the firmware added to the Gently shake the Physilog 6S to enter detection mode Click on Select device button and look for surrounding Physilog Select connect of one Physilog 6S sensors in the list Plug the selected Physilog to a power source to be sure to have enough battery to perform Click on Upload and wait until the percentage has arrived at 100%, this may take some Plug the Physilog to the computer and update the date and time (see above) 5.4. Tips for best practices Physilog 6S should be handled carefully. In particular, it should not receive shocks, such as fall, crushing, being hit etc. Do not press too hard on the on/off button, this can damage the button. Warning: Do not use or charge the Physilog if the sensor or its case is damaged. Contact Gait Up about what further action is needed when the case is damaged. In case the battery is damaged, immediately move the device away from flammable materials and contact Gait Up's customer support. To benefit from the maximal battery life, fully charge Physilog sensors before doing measurements (LED shines green when connected to computer or charger, you can also check with the App). Copy trial recordings to your computer: Physilog is not the best place to keep important data. Physilog 6S can be used outside when the temperature is not exceeding 30 C. Do not use Physilog 6S to measure water-sport activities without additional waterproofing. Do not introduce pointy objects into the small hole on the bottom of the sensor, this irreversibly damages the waterproofing of the sensor. Sensors do not need systematic yearly recalibration. Depending on the use, regular recalibration can be recommendable for: offset and gain dependent measures such as sensor orientation calculation. Make sure to know which Physilog file corresponds to which trial for your analysis First digits of file name are automatically incremented for each day of measurement (exceeding 99 resets the increment back to 1). It is recommended to delete old files from the sensor memory. Note that date of file generation (recorded between one start and stop of the Physilog 6S user manual v1.2.0 Date: 26.01.2021 Copyright 2021, All Rights Reserved - Gait Up SA. CH-1015 Switzerland www.gaitup.com 9 Physilog) is visible in the XLS or CSV file and the Matlab structure header. If you wish to adapt internal date and time of the Physilog, read the section above. Do not remove the conf.bin file from the Physilog, otherwise it will return to a default configuration. If this happens, update your configuration in the Research ToolKit software or contact Gait Up's customer support. 5.5. Maintenance and Disposal Cleaning: Before you clean the device make sure it is turned off and disconnect all cables. Use water and soap, saline solution or 3% Hydrogen peroxide (H2O2) solution to clean the Physilog 6S sensor device and its fixation clip accessories. Do not use a cleaning spray, but carefully wipe all parts using a humid wipe. Storage: Store in a cool (0C 30C) and dry place. The provided box is the perfect place for your sensor. Keep away from direct sunlight. Do not throw Physilog sensors in the normal trash, dispose of it properly considering local laws and rules about electronic waste and batteries. Contact Gait Up's customer support for more information about elimination of Physilog. Physilog 6S user manual v1.2.0 Date: 26.01.2021 Copyright 2021, All Rights Reserved - Gait Up SA. CH-1015 Switzerland www.gaitup.com 10 Safety information Physilog 6S includes a lithium battery. This battery may only be charged over a limited temperature range. Never attempt to dock or charge your Physilog 6S when the temperature is outside of the range of 0 to 45C. Physilog 6S should be charged through USB connection with a computer. An external charger may be used; note that no charger is provided by Gait Up. Gait Up declines any responsibility due to charger usage. Supply voltage should be as follows: DC, 5V. Current consumption is 100mA. All external circuits connected to the Physilog 6S should be Safety Extra Low Voltage and limited Power Sources circuits as described in the following standard:IEC62368-1:2014+/A11:2017 Warnhinweise:

Physilog 6S enthlt eine Lithium Batterie. Die Batterie soll nur in einer definierten Temperaturspanne aufgeladen werden. Versuchen Sie nie Ihren Physilog 6S an den Computer anzuschliessen oder aufzuladen, wenn die Aussentemperatur nicht zwischen 0C und 45C ist. Sensoren sollen durch eine USB Verbindung mit einem Computer aufgeladen werden. Ein externes Ladegert kann benutzt werden; Gait Up empfiehlt und liefert aber kein externes Ladegert. Gait Up bernimmt keine Haftung falls ein Ladegert gebraucht wird. Die erlaubte Netzspannung ist: DC, 5V. Stromaufnahme betrgt 100mA. Alle an den Physilog 6S angeschlossenen externe Stromkreise sollen die Sicherheitskleinspannung und mit begrenzter Leistung Regeln erfllen, die im folgenden Standard beschrieben sind: IEC 62368-1:2014+/A11:2017 Informations relatives la scurit:

Physilog 6S contient une batterie au lithium. La batterie ne doit tre charge que si la temprature extrieure est dans les limites dfinies. Nessayez jamais de connecter ou charger votre Physilog 6S si la temprature ambiante est en dehors des limites de 0 45C. Physilog 6S doit tre charg par une connexion USB avec un ordinateur. Un chargeur externe peut tre utilis; mais Gait Up ne livre et ne recommande pas de chargeur. Gait Up refuse toute responsabilit lie lutilisation dun chargeur externe. La tension de rseau devrait tre: DC, 5V. La consommation de courant est de 100mA. Tout circuits connects Physilog 6S doivent tre trs basse tension de protection et source tension limit comme dcrit dans les normes suivantes: IEC 62368-1:2014+/A11:2017 Physilog 6S user manual v1.2.0 Date: 26.01.2021 Copyright 2021, All Rights Reserved - Gait Up SA. CH-1015 Switzerland www.gaitup.com 11 6. Sensor specifications Physical properties Dimensions 42,2 x 31,6 x 15 mm Weight IP Rating 15 gr Waterproof IP64 Operating Temperature From -0 to 35C Fixation Accessories Application dependant, Belt clip and shoe lace clip included Straps available by Gait Up (sold separately) USB-C interface USB-C, High-speed USB 2.0 Communication Bluetooth Low Energy (BLE) Operating frequency range: 2.402-2.480 GHz (TX & RX) Effective radiated power (max): 11.11 dBm Internal Memory 450MB Battery Electronics specifications Microcontroller Inertial Sensors Lithium Ion Polymer Accumulators 3.7V 240mAh Battery life: up to 20h continuous use (depends on sampling frequency) Number of recharging cycles > 500 cycles Nordic Semiconductors ARM Cortex M4 with floating-point for on-board processing 3D Accelerometer up to 16g 3D Gyroscope up to 2000/s Sampling frequency up to 512Hz Magnetic field sensor 3D magnetic field sensor up to 50mT Sampling frequency up to 256Hz Ambient Sensor Barometric altitude from 260 to 1260 hPa Temperature sensor accuracy of 1.5C Sampling frequency up to 64Hz Compatible charger minimum specifications Minimum specifications Input voltage: 100-240V AC, 50-60 Hz Output voltage: DC 5V 3A/9V 2A/12V 1.5A Efficiency: >85%

CE-marked & ROHS compliant USB-A connection Physilog 6S user manual v1.2.0 Date: 26.01.2021 Copyright 2021, All Rights Reserved - Gait Up SA. CH-1015 Switzerland www.gaitup.com 12 3D orientation 3D orientation of the sensor is calculated on-board during the measurement when in streaming mode. The Matlab function to read the .BIN file has the option to output the quaternions and Euler angles. 7. Troubleshoot Reset The reset is the manipulation which can be done if the Physilog is not working properly. To do a reset, hold the main button for 5 seconds. The LED blinks red/orange and then stops. If the

) or www.gaitup.com/support problem persists, fill out the contact form on the support page (

write an email to: contact@gaitup.com. Please indicate Physilog serial number and describe the problem in as much detail as possible (number of red blinks, last manipulation, firmware version etc.). LED indications Physilog 6S user manual v1.2.0 Date: 26.01.2021 Copyright 2021, All Rights Reserved - Gait Up SA. CH-1015 Switzerland www.gaitup.com 13 8. Limited Warranty & Support Policy Warranty:

Gait Up offers 12 months parts and labour on Physilog starting from the date of delivery. If within one year from the date of delivery to the customer the equipment does not comply with the foregoing Limited warranty, Gait Up will at Gait Ups option, repair, replace or refund the purchase price of the defective equipment free of charge to the customer. Customers requesting repair, replacement or refund are required to ship, the Physilog to Gait Up. As a condition of this warranty, customers must contact Gait Ups customer service for instructions on and approval of shipment prior to returning any defective Physilog. The warranty shall not apply to any product or component thereof which has been repaired or altered by anyone other than Gait Up in any manner so as, in Gait Ups judgement, to affect its service ability, or any product been subject to alteration, accident, misuse, abuse, neglect or abnormal wear. Gait up warrants solely to the original purchaser (customer). Only the terms expressed in this warranty shall apply and no distributor, corporation or individual is authorized to amend, modify or extend this warranty in any way. Gait Up shall have no liability for any consequential, incidental or special damages by reason of any act or omission or arising out of or in connection with the equipment or its rental, delivery, installation, maintenance, operation, performance or use, including without limitation any loss of use, lost revenue, lost profits or a cost associated with downtime. The obligations contained in this paragraph continue beyond the term of this limited warranty. Physilog and Gait Analysis Software are not considered as proper Medical Devices, since they do not support directly diagnosis, but they provide data which have to be analysed and approved by medical doctors for them to make their diagnosis. Reclamations regarding medical devices will not be considered. Support Policy:

Support does not include:

support for 3rd party hardware, software, mailing lists or web content writing or debugging customer applications and deployments detailed explanations of the engineering principles behind our software and hardware support for systemic problems beyond the scope of the actual Physilog and existing systems software (IT issues, computer operation) support for customers whose conduct fails to meet professional standards Occasionally we engage in more interactive support or consulting. Interactive support is a customer courtesy and is provided at Gait Ups discretion. It does not invalidate the support policy described above. There is no guarantee of performance, timeliness, or establishment of a continuous support relationship. Consulting is subject to acceptance of a formal statement of work. Physilog 6S user manual v1.2.0 Date: 26.01.2021 Copyright 2021, All Rights Reserved - Gait Up SA. CH-1015 Switzerland www.gaitup.com 14 9. Product compliance IC statement Under Industry Canada regulations, this radio transmitter may only operate using an antenna of a type and maximum (or lesser) gain approved for the transmitter by Industry Canada. To reduce potential radio interference to other users, the antenna type and its gain should be so chosen that the equivalent isotropically radiated power (e.i.r.p.) is not more than that necessary for successful communication. This device complies with Industry Canada licence-exempt RSS standard(s). Operation is subject to the following two conditions: (1) this device may not cause interference, and (2) this device must accept any interference, including interference that may cause undesired operation of the device. This device complies with Industry Canada radiation exposure limits set forth for general population. This device must not be co-located or operating in conjunction with any other antenna or transmitter. le prsent metteur radio peut Conformment la rglementation d'Industrie Canada, fonctionner avec une antenne d'un type et d'un gain maximal (ou infrieur) approuv pour l'metteur par Industrie Canada. Dans le but de rduire les risques de brouillage radiolectrique l'intention des autres utilisateurs, il faut choisir le type d'antenne et son gain de sorte que la puissance isotrope rayonne quivalente (p.i.r.e.) ne dpasse pas l'intensit ncessaire l'tablissement d'une communication satisfaisante. Le prsent appareil est conforme aux CNR d'Industrie Canada applicables aux appareils radio exempts de licence. L'exploitation est autorise aux deux conditions suivantes : (1) l'appareil ne doit pas produire de brouillage, et (2) le l'utilisateur de l'appareil doit accepter tout brouillage radiolectrique subi, mme si brouillage est susceptible d'en compromettre le fonctionnement. Le prsent appareil est conforme aux niveaux limites dexigences dexposition RF pour la population globale dfinies par Industrie Canada. Lappareil ne doit pas tre install proximit ou tre utilis en conjonction avec une autre antenne ou un autre metteur. FCC statement This document, which describes the instructions for use for an intentional radiator, cautions the user that changes or modifications not expressly approved by the Manufacturer could void the user's authority to operate the equipment.

[54 FR 17714, Apr. 25, 1989, as amended at 68 FR 68545, Dec. 9, 2003]

This device complies with Part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) this device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation. 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 Physilog 6S user manual v1.2.0 Date: 26.01.2021 Copyright 2021, All Rights Reserved - Gait Up SA. CH-1015 Switzerland www.gaitup.com 15 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. However, there is no guarantee that interference will not occur in a particular installation. If this equipment does cause harmful interference to radio or television reception which can be determined by turning the equipment off and on, the user is encouraged to try to correct interference by one or more of the following measures:

Reorient or relocate the receiving antenna. Increase the separation between the equipment and receiver. Connect the equipment into an outlet on circuit different from that to which the receiver is connected. Consult the dealer or an experienced radio/TV technician for help. Caution: the user that changes or modifications not expressly approved by the party responsible for compliance could void the user's authority to operate the equipment. IMDA Singapore statement Physilog 6S complies with the standards and specifications published by IMDA, is compatible with the public telecommunication networks in Singapore, and does not cause radio frequency interference to other authorised radio-communication networks. RF Exposure information Europe Maximum RF Output power (11.11 (13mW) peak EIRP at Cmid, Tmax) of the equipment is under 20mW, and then test result is compliant without additional measurement. So, EN 62311 (2008) low power / inherent compliance decision is applied FCC This device complies with FCC radiation exposure limits set forth for general population. This device must not be co-located or operating in conjunction with any other antenna or transmitter. IC - Canada (EN) This device complies with ISED radiation exposure limits set forth for general population. This device must not be co-located or operating in conjunction with any other antenna or transmitter. Physilog 6S user manual v1.2.0 Date: 26.01.2021 Copyright 2021, All Rights Reserved - Gait Up SA. CH-1015 Switzerland www.gaitup.com 16 IC - Canada (FR) Le prsent appareil est conforme aux niveaux limites d'exigences d'exposition RF aux personnes dfinies par ISDE. Lappareil ne doit pas tre install proximit ou tre utilis en conjonction avec une autre antenne ou un autre metteur.

: The separation distance between the user and/or bystander and the antenna and/or radiating element of the Note device is of at least 20mm. Physilog 6S user manual v1.2.0 Date: 26.01.2021 Copyright 2021, All Rights Reserved - Gait Up SA. CH-1015 Switzerland www.gaitup.com 17 0.0.1 0.0.2 0.0.3 0.0.4 0.0.5 0.0.6 0.0.7 1.0.0 1.1.0 1.2.0 Contact information At Gait Up, we welcome your feedback and questions. Please contact us at:

EPFL Innov Park - C CH-1015 Lausanne tel: +41 21 633 7527 mail: contact@gaitup.com web:

www.gaitup.com Version Changes Responsible Date Send to external Lab for electrical safety testing Rebekka Anker 6 oct. 2020 Update cleaning instructions Rebekka Anker 8 oct. 2020 Add RF exposure limit text Replace to official name Physilog 6S Rebekka Anker 20 nov. 2020 Add FCC and IC statement, add RF exposure Add information from labeling requirements Update cleaning instructions Rebekka Anker 27 nov. 2020 Add IMDA labelling requirements Ainara Bujanda 1 dec. 2020 ISED labelling requirements added Ainara Bujanda 09 DEC 2020 Addition of FCC license ID, charger specifications addition and correction of errors. Removal of IC compliance for PHY 6S V1.0 Ainara Bujanda 08 JAN 2021 Addition of IC compliance for PHY 6S V1.1 Ainara Bujanda 13 JAN 2021 Ainara Bujanda 26 JAN 2021 Change the separation distance between the radiation element and the human body to 20 mm Change order of FCC & IC statements according to suggestion from LCIE Physilog 6S user manual v1.2.0 Date: 26.01.2021 Copyright 2021, All Rights Reserved - Gait Up SA. CH-1015 Switzerland www.gaitup.com 18

LCIE SUD EST Laboratoire de Moirans Z.I. CentrAlp 170, Rue de Chatagnon 38430 MOIRANS - FRANCE FCCID:

2AYHH-PHY06GAITUP PRODUCT LABELING Page 1/2 LCIE SUD EST Laboratoire de Moirans Z.I. CentrAlp 170, Rue de Chatagnon 38430 MOIRANS - FRANCE LOCATION on product Page 2/2

Letter of Agency To:

Federal Communications Commission 7435 Oakland Mills Road Columbia, MD 21046-1609 Bureau Veritas Consumer Products Services Inc. One Distribution Center Circle #1 Littleton, MA 01460 March 17, 2021 We, the undersigned Mindmaze SA hereby authorize Anthony MERLIN, LCIE SUD EST, to act on our behalf in all matters relating to all processes required for FCC certification of our devices. Any and all acts carried out by the above agent on our behalf shall have the same effects as acts of our own. This authorization is valid until: April 1st, 2021 If you have any questions regarding this authorization, let us know please. Sincerely, Sylvain Bourriquet Signature

CONFIDENTIALITY REQUEST Bureau Veritas Consumer Products Services Inc. One Distribution Center Circle #1 Littleton, MA 01460 USA March 17, 2021 Re:

FCC ID:

Confidentiality request 2AYHH-PHY06GAITUP Gentlemen, Mindmaze SA requests, pursuant to 47CFR 0.457(d) and 0.459, post grant confidentiality for portions of the material contained in this application. The following document regarding this submission for FCC ID: 2AYHH-PHY06GAITUP shall be kept confidential:

LONG-TERM CONFIDENTIALITY:

1. Schematic Diagram of the equipment 2. Block Diagram description of the equipment 3. Operational description of the equipment

(file: Schematic - 2AYHH-PHY06GAITUP.pdf)

(file: Block Diagram - 2AYHH-PHY06GAITUP.pdf)

(file: Operational Description - 2AYHH-

PHY06GAITUP.pdf) Specifically, these exhibits contain information relating to circuit function and complexity that could be of benefit to competitors. The material contains trade secrets and confidential information that Mindmaze SA does not customarily release to the public and which is otherwise not generally available to the public. Regards, Responsible party:

Title:

Signature:

Sylvain Bourriquet Director, Quality Assurance and Regulatory Affairs

8 7 6 4 3 2 1 P O N M L K J I H G F E D C B A VERSION CLIP LACET VERSION CLIP CEINTURE 1 5 6 7 8 9 2 4 10 3 5 4 9 . 4 4 3 2 . 3 1 3 2 . 3 1 6 3 . 1 2 VERSION CLIP LACET VERSION CLIP CEINTURE D-D Dtail E 1 4 E C 5 2

. 8 1 C-C D E 7 4

. 6 2 A-A B B-B C A A RAL 7011 PANTONE 425 rgb (84,88,89) Diameter 8mm - centred on button dome (do not cover LED) D B P O N M L K F E D C B A 10 9 8 7 6 5 4 3 2 1 Numro Nbre DESIGNATION CARTE ELECTRONIQUE RING RING RING RING RING CLIP CEINTURE CLIP LACET BOTTOM TOP 1 1 1 1 1 1 1 1 1 1 INDICE / Level:

DATE / Date :

M1118-05PT SILICONE M1118-05PJ SILICONE M1118-05PR SOLICONE M1118-05PV SILICONE M1118-05PB SILICONE M1118-04P M1118-03P M1118-02P M1118-01P CODE ABS ABS ABS V0 ABS V0 MATIERE CREE PAR / Created by CREOPP-TEC DATE / Date 19/12/2019 TELEMAGENTA JAUNE ZINC ROUGE PUR VERT BRILLANT BLEU CLAIR GRIS BRILLANT GRIS BRILLANT GRIS BRILLANT BLANC BRILLANT COULEUR RAL 4010 PANTONE 213 C RAL 1018 PANTONE 108 C RAL 3028 PANTONE 185 C RAL 6038 PANTONE 802 C RAL 5012 PANTONE 306 C RAL 7016 RAL 7016 RAL 7016 RAL 9003 OBSERVATION DESIGNATION / Drawing name CAPTEUR PHYSILOG6 CREOPP-TEC VALIDE PAR / Valid. by REFERENCE / Part number PLANCHE / Sht. 240 rue des cables de Lyon NAG ENSEMBLE niveau / level 00 00 1/1 01000 ST DENIS LES BOURG Tel.04.74.32.23.60 Fax.04.74.32.23.48 DATE / Date 20/12/19 GAIT UP CLIENT / Customer REFERENCE CLIENT / Customer part number Echelle / Scale FORMAT / Size 2:1 A1 CE PLAN EST LA PROPRIETE DE CREOPP-TEC. IL NE DOIT PAS ETRE REPRODUIT OU COMMUNIQUE SANS NOTRE AUTORISATION ECRITE This drawing is the property of CREOPP-TEC. It can't be reproduced or communicated without our written autorisation. 8 7 6 5 4 3 2 1