User Manuals Freezing of Gait Aid System GA100-IFU-EN V1.
REVISION HISTORY Version No. V1.0 V1.
Manufacturer: GYENNO Technologies CO.,LTD. Address: A805 A806,Shenzhen Institute of Industry-University-Research of HUST,No.9 Yuexing 3rd Road,Science Park,Nanshan District,Shenzhen,518000,P.R.China Tel.: 0086-755-86724035 Email: service@gyenno.com Website: www.gyenno.
Table of Contents 1. INTENDED USE ............................................................................................................................ 7 2.SAFETY INFORMATION .................................................................................................................7 3.Review .........................................................................................................................................8 3.1 BRIEF INTRODUCTION ............................................
6 CLEANING AND DISINFECTION ....................................................................................................30 7 MAINTENANCE ...........................................................................................................................30 8 TROUBLESHOOTING ................................................................................................................... 30 9 PRECAUTIONS ..........................................................................................
Description of terms in this manual Warning Caution Attention Indicates a potentially hazardous situation which, if not avoided, could result in death or serious injury. Indicates a potentially hazardous situation which, if not avoided, may result in invalid data collecting ,damage to the equipment or invalid operation. Information necessary to be known before using the equipment.
1. INTENDED USE Freezing of Gait Aid System (hereinafter referred to as “the product”) is used to collect Freezing of Gait (FoG) data and alleviate FoG through visual and auditory prompting,help people with Parkinson's Disease improve their gait.For FoG's patients. 2.SAFETY INFORMATION WARNING 1. Do not place or store this device near an open flame or heat source. 2. Do not use a damaged power cord or outlet. 3. Do not use other charger that is not designed for this product char 4.
sparks due to transient discharge. 18. Do not use this product outdoors in inclement weather. 19. Do not use the Binaural earphones. 20. Disposal of this product must be handled in accordance with local regulations, otherwise it may cause pollution. 21. Use this product with caution when working on wet floors. 22. Please use the laser hint function of this product carefully in bright light environment. 23. Please be cautious in using the audio hint function of this product in noisy environments. 24.
3.1 BRIEF INTRODUCTION The product collects and automatically analyzes the user's gait data through motion sensors, intelligently identifies FOG, and gives visual (laser) and/or audible (audio) hint to help the user unfreeze. At the same time, the product records the information of the user’s frozen gait, which can assist the doctor to quantitatively evaluate the patient's symptoms. Image 1 Freezing of Gait Aid System 3.
Product Model Item No.
3.2.1 AI CENTER Image 3 AI Center Name：AI Center Model：PU100 Part Description On/Off button - Click to open the AI Center when it is shut down. 1 - Click to turn on/turn off the hint when the AI Center is turned on - When the calculation center is turned on, press and hold the AI Center for about 3 seconds to turn it off. 2 3 4 Volume button "+" - Increase the volume. Volume button"-" - Decrease the volume . The indicating light shows the working status of the AI center. For details, see "4.
3.2.2 LASER Image 4 Laser Name：Laser Model：L100 Part Description 1 Lens knob. 2 Laser head. 3 The indicating light shows the working status of the laser node. For details, see "4.3 Indicating Light Description". 4 The rotating shaft can be rotated to adjust the direction of the laser line. 5 Laser warning label. 6 Charging hole for plugging in the charging base.
3.2.3 COLLECTOR Image 5 Collector The collector is divided into two models： 1）Name：Collector(Left) Model：SM120L： 2）Name：Collector(Right) Model：SM120R： Part 1 2 Description Indicator arrow for wearing direction The indicating light shows the working status of the collector, for details, see "4.3 Indicating Light Description". Wearing location identifier 3 - "R" stands for the location on the right ankle - "L" stands for the left ankle location 4 Charging hole for plugging in the charging base.
3.2.4 EARPHONE Image 6 Single hole earphone Part Description 1 Earplug 2 Earphone cable 3 Audio plug Chart 5 Earphone 3.2.
3.3 WORKING CONDITIONS Conditions Parameters Environment +5 ℃ ~ +45 ℃ Temperature Relative Humidity 10% ~ 95% (No condensation) Atmospheric Pressure 70kPa ~ 106kPa Chart 6 Working Conditions 3.4 TRANSPORTATION AND STORAGE CONDITIONS Conditions Parameters Environment -20 ℃ ~ +60 ℃ Temperature Relative Humidity 10% ~ 95% (No condensation) Atmospheric Pressure 70kPa ~ 106kPa Chart 7 Transportation and Storage Conditions 3.
Decrease Volume Switch Non-ionizing radiation Authorized representative in the European Community Medical device Manufacturer Chart 8 Symbols Used in This Device 4 SPECIFICATIONS AND PARAMETERS 4.
Range Charging 1200mAh BLE/Classic BT voltageB DC 5V 2402MHz ～ 2480MHz attery capacity Charging Base CB100 Laser Charging time ≤4 h Size Approximately 96 (L) * 68.4 (W) * 16.5 (H) (mm) Weight 88 g Input DC 5V2A Size Approximately 200.6 (L) * 88 (W) * 40.6(H) (mm) Weight Approximately 200 g Bluetooth Wireless L100 BLE standard Frequency 2402MHz ～ 2480MHz Range Collector SM120 Battery Capacity DC 3.7V 210mAh lithium battery Laser Wavelength 514nm Power 0.
4.
Image 8 Wearing Solutions Item No.
and download from the following channels: Cybersecurity “SKYWALK” APP needs to use user name and password for user authentication, and can log in and view data only after passing the authentication; If verification failed, use will be unable to log in and system will give a prompt. iOS device: Please search for “SKYWALK” in the App Store and download and install it. Android device: Please search for “SKYWALK” in all major Android application markets, download and install it.
5.2.3 DEVICE BINDING After the user log in, please follow the user guide of the APP to complete the device binding operation. ATTENTION 1. When you bind the device, you need to use the mobile phone to scan the QR code on the label at the back of the AI center. 2. If the bound AI center needs to be replaced, you must unbind it in the APP and then re-bind the device. 5.2.4 NETWORK CONNECTION Please follow the steps below to complete the WiFi network connection. 1.
AI center Laser nodes Collector nodes Waist/Cane Mode Configuration 1 1 2 Shoe Mode Configuration 1 2 0 * If the wearing mode is switched, the mode configuration must be changed. Waist/Cane mode network status : Shoe mode network status: Please follow the steps below to complete the configuration of the AI center and each node of the device: 1. Specify the corresponding mode configuration according to the way you want to wear the device. 2.
5.2.6 HINT MODE SETTING The device has two hint modes: 1） Laser hint: laser line is projected in front of the user's walking, guiding the user to walk normally by vision. 2） Audio hint: beat rhythm is played in the earphone, and user is encouraged to walk normally by audio. Users can set the hint mode in the APP. 1) Only laser hint is turned on. 2) Only audio hint is turned on. 3) Laser hint and audio hint are simultaneously turned on.
Wearing mode 1 Wear the laser node on the waist Image 9 Wearing mode 1 2.
3. WEARING MODE 3(SHOE) Wearing mode 3 (shoes) Wear the laser node on the shoes Image 23 Wearing mode 2 ATTENTION 1. The left and right ankle straps is different from each other, please distinguish them before use; 2. The laser head of laser node must face down; 3. Ensure that the AI center is within 3 meters from the collector node and the laser node; 4. The AI center should be carried around and can be hung on your chest or put in your pocket.
5.3.2 POWER ON AND OFF When the wearing is completed, press the power button of the AI center to turn on the device. If the indicating light of AI center is green, you can start using the product; if the indicating light of AI center is yellow, check if the battery is low. Press and hold the switch button for about 5 seconds to turn off the AI center. Image 24 turn on/off ATTENTION After the AI center is not in use for 5 minutes, the indicating light goes out and the device automatically turns off. 5.
the correct direction of the laser line is parallel to the toe.
1. The laser cannot be projected directly into eyes, laser projected onto a person should be avoided. 2. Users should not only attention the laser line, but must also pay attention to the surrounding environment while walking. WARNINGS OF AUDIO INTERFERENCE Earphone can be used by directly plugging into the AI center. Warning 1. Do not use binaural earphone. 2. Users should not only attention the audio rhythm, but also pay attention to the surrounding environment. 5.3.
Caution If no measurement results are shown, it may be caused by the following reasons: 1. None or incomplete data transfer due to WiFi connection problems or others. 2. The measurement is terminated. The measurement time is insufficient or it’s not an actual measurement. 5.4 AFTER USING 5.4.1 END OF USE Please power off, take off straps from your body and remove AI center and each node from the straps. It is suggested that the device should be cleaned each time after using. 5.4.
charging base and connect to the external power supply of DC 5V/2A. The indicating light stays in yellow while charging and it turns to green when charged. 6 CLEANING AND DISINFECTION The plastic shell parts of AI center, charging base, cane and nodes can be washed with a cotton swab, neutral detergent and clean water. Do not use sharp tools such as toothpicks, tweezers, and knives for cleaning. Dry it with a clean, soft cotton swab. Do not use corrosive solutions to wipe or clean.
2. The device is already bound by another user. Please call the customer service hotline. 3.The QR code is missing or damaged and cannot be scanned. Please call the customer service hotline. 1. Enter the wrong wireless network password. Please enter the correct wireless network password and try again. Unable to connect network 2. The device exits the connecting state due to timeout. Please try again according to the "Network connection" section. 3. The wireless network signal is weak.
10 CONTRAINDICATIONS • Do not use the device for patients with implanted metal such as pacemakers, nerve stimulators and artificial metal heart valves. • Users who have other metal implants should follow doctor’s advice.
11 EMC INFORMATION Guidance and manufacture’s declaration – electromagnetic emission The device is intended for use in the electromagnetic environment specified below. The customer or the user of the device should assure that they are used in such an environment. Emission test RF emissions CISPR 11 RF emission CISPR 11 Harmonic emissions IEC/EN 61000-3-2 Compliance The device uses RF energy only for their internal function.
Guidance and manufacture’s declaration – electromagnetic immunity The device is intended for use in the electromagnetic environment specified below. The customer or the user of the device should assure that they are used in such an environment. Immunity test IEC/EN 60601 test level Compliance level Electromagnetic environment - guidance Floors should be wood, concrete or ceramic Electrostatic discharge (ESD) ± 8 kV contact ± 8 kV contact IEC/EN 61000-4-2 ± 15 kV air ± 15 kV air tile.
Guidance and manufacture’s declaration – electromagnetic immunity The device is intended for use in the electromagnetic environment specified below. The customer or the user of the device should assure that they are used in such an environment.
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 assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered.
5240 5500 5100-5800 WLAN 802.11 a/n Pulse modulation b) 217 Hz 0,2 0,3 9 5785 NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies. NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. a) For some services, only the uplink frequencies are included. b) The carrier shall be modulated using a 50 % duty cycle square wave signal.
12 REGULATORY INFORMATION FCC Caution: Any Changes or modifications not expressly approved by the party responsible for compliance could void the user's authority to operate the equipment. 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.
14 DISPOSAL GYENNO has always been committed to earth care, we also encourage our users to make contribution by executing proper disposal: ● Packaging materials should be handed to local recycling companies for the possibility of re-use. ● Comply with relevant laws and regulations when disposing wasted parts and components. ● This device should be disposed as electronic waste. 15 COPYRIGHT AND RESPONSIBILITY The copyrights and confidentiality of this manual are owned by GYENNO.
