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Summary of Contents for Gyenno Freezing of Gait Aid System
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User Manuals Freezing of Gait Aid System GA100-IFU-EN V1.1 - 1 -...
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REVISION HISTORY Version No. Contents and reasons for revision Revision date Reviser V1.0 New Fiction 2021-11-03 Qianyu Liu Update the content according to the requirements of external V1.1 2022-05-17 Qianyu Liu inspection agencies - 2 -...
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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.com - 3 -...
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Description of terms in this manual Indicates a potentially hazardous situation which, if not avoided, could result in death or serious injury. Warning Indicates a potentially hazardous situation which, if not avoided, may result in invalid data collecting ,damage to the equipment Caution or invalid operation.
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.
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.
Image 1 Freezing of Gait Aid System 3.2 COMPOSITION This product is mainly composed of AI center, laser, collector, earphone and application software.
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Product Model GA100 Item No. Part Name Part Model Support three wearing solutions (Waist, Cane, Vamp) AI Center PU100 Laser L100 Collector (Left) SM120L Collector(Right) SM120R Earphone E100 Accessories Waist belt Cane strap Ankle strap (Left) Ankle strap (Right) Vamp strap (Left) Vamp strap (Right) USB charging cable Charging base...
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. - 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.
3.2.2 LASER Image 4 Laser Name:Laser Model:L100 Part Description Lens knob. Laser head. The indicating light shows the working status of the laser node. For details, see "4.3 Indicating Light Description". The rotating shaft can be rotated to adjust the direction of the laser line. Laser warning label.
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 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 - "R"...
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 4.1 SPECIFICATIONS Product/Part Main Parameter Description Main configuration: AI Center *1, laser *2, Collector*2, earphone *1; Model GA100 Support two kinds of node configuration A/B,three wearing solutions 1/2/3...
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Range Charging 1200mAh BLE/Classic BT voltageB DC 5V 2402MHz ~ 2480MHz attery capacity Charging time ≤4 h Size Approximately 96 (L) * 68.4 (W) * 16.5 (H) (mm) Weight Charging Base Input DC 5V2A CB100 Size Approximately 200.6 (L) * 88 (W) * 40.6(H) (mm) Weight Approximately 200 g Laser...
4.2 INDICATING LIGHT DESCRIPTION Part Light color Status description Green breathing Standby mode Green Charging completed/Normal Operation Blue flashes Uploading data or upgrading device while charging AI Center Yellow flashes four times WIFI network configuration failed / node configuration failed Yellow Low battery status/Charging, not fully charged Red flashing...
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. You can also go to http://www.gyenno.com/ to download the application. Operating Environment Hardware Configuration: RAM≥1 GB ROM≥8 GB...
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.
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AI center Laser nodes Collector nodes Waist/Cane Mode Configuration Shoe Mode Configuration * 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.
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.
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Wearing mode 1 Wear the laser node on the waist Image 9 Wearing mode 1 2. WEARING MODE 2(CANE) Wearing mode 2 (cane) Wear the laser node on the cane Image 10 Wearing mode 2 - 24 -...
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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.
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.
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the correct direction of the laser line is parallel to the toe. If not, adjust the laser node axis and lens knob: 1) Distance adjustment Rotate the angle of the laser node’ axis to control the projection position of the laser line, the distance between the laser line and the user should be controlled at 20~50cm, as shown in Image 25: Image 25 Laser node 2) Direction adjustment...
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 ...
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.
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, ...
2. Battery or charging component failure Please contact the manufacturer. Others Please stop using the device and contact GYENNO Serivce. Chart 10 Troubleshooting 9 PRECAUTIONS • It is suggested to proactively adjust wearing modes and try visual or auditory hints to find the best way to wear and intervene at the beginning of adopting the equipment.
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. - 32 -...
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 Compliance Electromagnetic environment –...
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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...
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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 Portable and mobile RF communications device...
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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. If the measured field strength in the location in which the device is used exceeds the applicable RF compliance level above,...
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5240 5500 5100-5800 WLAN 802.11 a/n Pulse modulation 217 Hz 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.
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.
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