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.
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.
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.
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.
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. NOTE: In order to generate reports, the Gait Up GO Mobile Application needs to be connected to the Internet by using WiFi or mobile data. 4.5.
Fig. 75. Confirmation request - iOS NOTE: In order to generate reports, the Gait Up GO Mobile Application needs to be connected to the 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).
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.
It is highly recommended to save the results to the patient folder and/or the medical professional’s 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.
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.
Fig. 83.
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.
Fig. 84. How to access to the “History” section - iOS Fig. 85.
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 For each report generated for this test and participant, the test result value of the parameter is displayed.
5. CLEANING, MAINTENANCE AND STORAGE 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.
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 the casing. Store it in a cool (-20 - +60°C) and dry place at a stable temperature and ambient humidity (25%-70%, non-condensing). 5.4. Environmental conditions for operation.
6. TROUBLESHOOTING What do you see/hear Problem What to do More Information 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 Make sure that the sensor device accessory is in proximity of your mobile device.
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.
Customer Support The customer support is provided by: Gait Up SA EPFL Innovation Park Bâtiment C CH-1015 Lausanne Switzerland Phone: +41 21 633 7527 (office hours: 8h30 to 17h30 CET, Monday to Friday) General contact email: contact@gaitup.com Email: support@gaitup.
7. WARRANTY 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.
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.
9. TECHNICAL SPECIFICATIONS 9.1. Specifications Gait Up GO medical device Regulatory Classification MDD: Class I medical device according to Rule 12 of Annex IX 93/42/EEC Size 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 Weight Physilog6 sensor device: 0.015 kg Fixation accessories: ● shoe lace clip: 0.03 kg ● belt clip: 0.08 kg USB cable: 0.
● 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 Mobile Phone CISPR 32 compliant Yes RoHS compliant Yes Wi-FI connectivity Yes Bluetooth wireless communication Bluetooth 4.
OS Android (7.0 or higher) and iOS (11..0.0 or higher) Battery life > 3 hours Table 8. Technical specifications 9.2.
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 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 10. EMI emissions 9.4.
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 11. Electromagnetic emissions 9.5.
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 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 @ 80MHz-2.7GHz 80% AM à 1kHz 10 V/m @ 80MHz-2.
● manufacturer and D is the recommended separation distance in meters (m) (b).
5240 – 5500 5785 Conducted RF immunity IEC 61000-4-6 Modulation pulsée 217 Hz 3 V 0,15 MHz – 80 MHz 6 V in ISM bands, between 0,15 MHz and 80 MHz 80 % AM @ 1 kHz 9 3 V 0,15 MHz – 80 MHz 6 V in ISM bands, between 0,15 MHz and 80 MHz 80 % AM @ 1 kHz 9 If the measured field strength in 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.
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 0.06 0.06 0.2 0.1W 0.19 0.19 0.63 1W 0.6 0.6 2 10W 1.90 1.90 6.
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.
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 Canada’s 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 Exposition humaine - Version française Le présent appareil est conforme aux niveaux limites d'exigences d'exposition RF aux personnes définies par ISDE. L’appareil ne doit pas être installé à proximité ou être utilisé en conjonction avec une autre antenne ou un autre émetteur. Note : La distance de séparation entre l'utilisateur et/ou le spectateur et l'antenne et/ou l'élément rayonnant de l'appareil est d'au moins 20 mm. 9.9 RF exposure compliance - Europe Maximum RF Output power (11.
10.
11. LEGAL MANUFACTURER 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: contact@gaitup.com Support Mail: support@gaitup.com Web: www.gaitup.