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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)

●

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.

ENGLISH

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Содержание GAIT UP GO

Страница 1: ...ENGLISH D 2017 LBL 0083 AAA Sep 2020 ...

Страница 2: ...I NSTRUCTIONS FOR U SE H OME USE G AIT U P GO ENGLISH 2 51 ...

Страница 3: ...witzerland Contact email xxxxxxxx Website www mindmaze ch Commercialized by Gait Up SA EPFL Innovation Park Batiment C CH 1015 Lausanne Switzerland General Contact email contact gaitup com Website https clinical gaitup com Support email support gaitup com ENGLISH 3 51 ...

Страница 4: ...SCOVER THE P HYSILOG 6 SENSOR DEVICE 20 4 3 C HARGING OF THE P HYSILOG 6 SENSOR DEVICE21 4 4 C HECKING SYSTEM COMPONENTS AND THEIR FUNCTIONALITY 21 4 5 O PERATING THE MEDICAL DEVICE 22 4 5 1 O PENING THE MOBILE APPLICATION 22 4 5 2 C ONNECTING P HYSILOG 6 SENSOR DEVICE TO THE MOBILE APPLICATION 23 4 5 3 P HYSILOG 6 SENSOR DEVICE INFORMATION SCREEN 24 4 5 4 P ERFORMING A TEST 27 5 C LEANING M AINTE...

Страница 5: ... Fig 3 15 Fig 4 17 Fig 5 20 Fig 6 23 Fig 7 23 Fig 8 24 Fig 9 25 Fig 10 25 Fig 11 26 Fig 12 27 Fig 13a 28 Fig 13b 28 Fig 14 28 Fig 15 29 Fig 16 29 Fig 17 30 Fig 18 31 Fig 19 31 Fig 20 32 Fig 21 32 Fig 22 32 Fig 23 33 Fig 24 34 Fig 25 34 ENGLISH 5 51 ...

Страница 6: ...3 Table 3 Physilog6 sensor components 16 Table 4 Automatic test end criteria 31 Table 5 Troubleshooting 38 Table 6 Technical specifications 43 Table 7 Symbols 45 Table 8 EMI emissions 45 Table 9 Electromagnetic emissions 46 Table 10 Electromagnetic immunity 48 ENGLISH 6 51 ...

Страница 7: ...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 Physilog 6 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 Physilog 6 if the sensor its case or...

Страница 8: ...on behind such hole in the device 1 1 2 Warnings related to the conditions and awareness of the end users DO NOT use the Gait Up GO in other parts of the Participant body but in the ones indicated in the Instructions For Use DO NOT manipulate or remove Gait Up Go accessories from the user body during the session Accurate results are only guaranteed if the Physilog6 sensor accessory is firmly attac...

Страница 9: ...itive 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 ...

Страница 10: ...ould be reported to the legal manufacturer Mindmaze SA and the competent authority of the Member State in which the user and or the Participant is established Inform your Healthacre Professional who has prescribed you the medical device if you notice adverse reactions ENGLISH 10 51 ...

Страница 11: ...tions 2 2 Intended use 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 ...

Страница 12: ...al 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 ...

Страница 13: ...y external power supply mobile phone charger other than the one provided by your Healthcare Professional 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 devi...

Страница 14: ...3 2 Description of device components Fig 1 Gait Up GO device components Gait Up Go Mobile Application Fig 2a Android application Fig 2b iOS application ENGLISH 14 51 ...

Страница 15: ...des guidance to the users on how and where to place the Physilog6 sensor device on the Participant s body see section 4 for further details 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 The Physilog6 sensor device is operated via the Gait Up GO mobile application to perform the...

Страница 16: ...ng green Warnings Blinking yellow 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 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 comput...

Страница 17: ...al 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 Device case 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 position...

Страница 18: ...ndicators 3 3 1 Visual user indicators related to battery charging 3 3 2 Visual and auditory indicators related to the operation of the device Physilog6 sensor device visual and auditory indicators ENGLISH 18 51 ...

Страница 19: ...Gait Up GO mobile application visual indicators 1 Information messages 2 Error messages ENGLISH 19 51 ...

Страница 20: ...e The medical professional has programmed the Gait Up GO medical device specifically for you Open the mobile application already pre installed in the mobile device tablet provided by the healthcare professional Your profile will automatically be shown on the screen Clip the Physilog6 sensor device in the clip accessories Select one of the tests prescribed by your Healthcare Professional that appea...

Страница 21: ...ensor 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 Physilog...

Страница 22: ...nection 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 your Healthacre Professional who has prescribed you the medical device A Participant must not wear more than one Physilog6 accessory ...

Страница 23: ...r to connect the Physilog6 sensor device to the mobile application follow the next steps Open the mobile application Gently shake the sensor device The mobile application will automatically connect to the sensor device Fig 7 Connection status indicator on the mobile application s main screen ENGLISH 23 51 ...

Страница 24: ...se the following information will pop up Fig 8 Information pop up bluetooth status indicator Note If you have any repetitive connection issues between the mobile application and the sensor device please contact the healthcare professional who prescribed you the medical device 4 5 3 Physilog6 sensor device information screen The Physilog6 sensor device information screen can be accessed by tapping ...

Страница 25: ...ormation about the connection status of the sensor device its battery level and the firmware version running on it In case there is a firmware update available this screen will notify it to you and will give you the option of performing such an update Fig 10 Physilog6 sensor device s information screen ENGLISH 25 51 ...

Страница 26: ...update the sensor press the Update Physilog button in the sensor information window Fig 11 Physilog information update screen 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 ...

Страница 27: ... 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 9 If the battery is lower than 25 the Gait Up GO Mobile Application will not allow it to start any test The battery level indicating the battery status of the connected Physilog6 sensor device on the Mobile Application Screen is shown in Figure 11 S...

Страница 28: ...dy Depending on the test choice instructions and sensor locations are different Be careful to correctly place the sensor at the location indicated in the test instructions provided inside the Gait Up GO application For any question please contact the Healthcare Professional who prescribed you the medical device Fig 14 Possible sensor locations back of the belt foot side of the belt ENGLISH 28 51 ...

Страница 29: ... must not touch the participant s skin use the belt strap over the clothes if the subject is not wearing a belt Carefully read the instructions given in the Gait Up GO Mobile Application for the selected test to know where to place the sensor Fig 15 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 un...

Страница 30: ...ined 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 NOTE some tests stop automatically after the movement is completed or after a fixed amount of time f ex 2min walking test 5 sit...

Страница 31: ... 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 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 explain...

Страница 32: ...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 20 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 ...

Страница 33: ...pted 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...

Страница 34: ...t access to the results At the end of the test a message will pop up informing that the test results have been saved The report can be accessed from this point on at any time by the medical professional no remote access Fig 24 Test has been saved iOS Fig 25 Test has been saved Android After tapping OK on the information text box the mobile application displays the session screen from where the use...

Страница 35: ...rial 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 Physilog 6 sho...

Страница 36: ...e temperature and ambient humidity 25 70 non condensing 5 4 Environmental conditions for operation The Gait Up GO medical device must be used in accordance with the following conditions Temperature 0 30 C Humidity 10 70 Pressure 600 1070 hPA The Gait Up GO medical device must be stored in accordance with the following conditions Temperature 20 60 C Humidity 25 70 Pressure 600 1070 hPA The Gait Up ...

Страница 37: ... 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 If the linked sensor device does not correspond to the sensor in your possession contact your healthcare professional who has prescribed the device The Gait Up GO mobile application displays an error pop up after you select a test indicating ...

Страница 38: ...d orange The Physilog6 sensor device accessory has performed a reset Nothing needs to be done the sensor device accessory just solved its issue on its own The Gait Up GO mobile application can trigger a reset of the sensor device accessory without your intervention if it detects a problem The Physilog6 sensor device accessory is blinking orange during the recording The battery of the sensor device...

Страница 39: ... beep Release the button and wait until the blinking stops Reporting an adverse event If any serious incident occurs that is directly or indirectly related to the use of Gait Up GO medical device please report it immediately your healthcare provider who prescribed you the medical device ENGLISH 39 51 ...

Страница 40: ...sed 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 your healthcare provider who prescribed you the medical device The healthcare professional will ...

Страница 41: ...e casing POLYLAC PA 765 Flame retardant acrylonitrile butadiene styrene ABS copolymer Clip accessories CYCOLAC RESIN HMG94MD Acrylonitrile Butadiene Styrene ABS for medical applications USP grade IV USB cable PVC Power source Internally powered Rechargeable battery Lithium Ion rechargeable battery 3 7V nominal Power plug USB C Battery life Number of recharging cycles 500 cycles User indicators Gai...

Страница 42: ...Hz Output voltage DC 5V 3A 9V 2A 12V 1 5A Efficiency 85 CE marked ROHS compliant USB A connection Mobile Phone CISPR 32 compliant Yes RoHS compliant Yes Wi FI connectivity Yes Bluetooth wireless communication Bluetooth 4 0 or higher with BLE frequency of 128Hz or higher Minimum screen size 4 7 inch Minimum screen resolution 750x1334 OS Android 7 0 or higher and iOS 11 0 0 or higher Battery life 3 ...

Страница 43: ...creen resolution 1200x1920 OS Android 7 0 or higher and iOS 11 0 0 or higher Battery life 3 hours Table 6 Technical specifications 8 2 Symbols Symbol Description Legal manufacturer Reference number CE mark Read Accompanying document Do not send the device or any of its accessories to a standard garbage ENGLISH 43 51 ...

Страница 44: ...Caution Logo Warning Logo Applied part logo Accepted humidity range Accepted temperature range Non ionizing radiation FCC symbol USA IC symbol Canada Fragile handle with care ENGLISH 44 51 ...

Страница 45: ...ndling label Device under prescription logo Table 7 Symbols 8 3 EMI emissions System Characteristics Description Function Recording Frequency mHz 2402 2480 Max declared output power dBm 8 Max antenna gain dBi 1 Max E I R P dBm 11 11 Max E I R P mW 12 91 Table 8 EMI emissions ENGLISH 45 51 ...

Страница 46: ...ses RF energy only for its internal function Therefore its RF emissions are 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 N A N A Voltage fluctuations Flockers emissions IEC 61000 3 3 N A N A Table 9 Electromagnetic emissions 8 5...

Страница 47: ... voltage variations on power supply lines IEC 61000 4 11 N A 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 Power frequency magnetic fields should be at levels characteristic of a typical commercial or hospital environment Radiated RF immunity IEC 61000 4 3 10 V m 2450 spot frequency MHz 10 V m 2450 spot frequency MHz Portable and mob...

Страница 48: ...ation distance in meters m b Field strengths from fixed RF transmitters as determined by an electromagnetic sute 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 Table 10 Electromagnetic immunity Note a Field strengths from fixed transmitters such as base stations for ra...

Страница 49: ...strength in the location in which the device is used exceeds the applicable RF compliance level above theGait Up GO medical device should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as reorienting or relocation of the Gait Up GO medical device Note b Over the frequency range 150 kHz to 80 MHz field strengths should be less th...

Страница 50: ...9 A LPHABETICAL INDEX ENGLISH 50 51 ...

Страница 51: ...and 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 contact gaitup com Support Mail support gaitup com Web www gaitup com ENGLISH 51 51 ...

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