all | frequencies |
|
|
|
|
exhibits | applications |
---|---|---|---|---|---|---|---|
manual | photos | label |
app s | submitted / available | |||||||
---|---|---|---|---|---|---|---|---|
1 |
|
User Manual | Users Manual | 2.34 MiB | July 25 2022 | |||
1 |
|
Internal Photos | Internal Photos | 688.64 KiB | July 25 2022 | |||
1 |
|
External Photos | External Photos | 382.23 KiB | July 25 2022 | |||
1 |
|
Label | ID Label/Location Info | 177.66 KiB | July 25 2022 | |||
1 | Block Diagram | Block Diagram | July 25 2022 | confidential | ||||
1 |
|
FCC Long Term Only Confidentiality Request Rev4.1 | Cover Letter(s) | 86.27 KiB | July 25 2022 | |||
1 |
|
LetterofAuthorizationRev2.0 | Cover Letter(s) | 121.09 KiB | July 25 2022 | |||
1 | OP | Operational Description | July 25 2022 | confidential | ||||
1 | SCH | Schematics | July 25 2022 | confidential | ||||
1 | Schematic WiFi Module | Schematics | July 25 2022 | confidential | ||||
1 |
|
Test Report | Test Report | 3.20 MiB | July 25 2022 | |||
1 |
|
Test ReportSAR | RF Exposure Info | 3.88 MiB | July 25 2022 | |||
1 |
|
Test Setup Photos | Test Setup Photos | 242.66 KiB | July 25 2022 | |||
1 |
|
Test setup photosSAR | Test Setup Photos | 220.49 KiB | July 25 2022 |
1 | User Manual | Users Manual | 2.34 MiB | July 25 2022 |
User Manuals Freezing of Gait Aid System GA100-IFU-EN V1.1
- 1 -
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 inspection agencies 2022-05-17 Qianyu Liu
- 2 -
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 -
Table of Contents 1. INTENDED USE ............................................................................................................................ 7 2.SAFETY INFORMATION .................................................................................................................7 3.Review .........................................................................................................................................8 3.1 BRIEF INTRODUCTION .......................................................................................................................9 3.2 COMPOSITION ..................................................................................................................................9 3.2.1 AI CENTER ............................................................................................................................................................. 11 3.2.2 LASER .................................................................................................................................................................... 12 3.2.3 COLLECTOR ............................................................................................................................................................13 3.2.4 EARPHONE ............................................................................................................................................................ 14 3.2.5 ACCESSORIES .........................................................................................................................................................14 3.3 WORKING CONDITIONS .................................................................................................................. 15 3.4 TRANSPORTATION AND STORAGE CONDITIONS ............................................................................... 15 3.5 SYMBOLS USED IN THIS DEVICE ....................................................................................................... 15 4 SPECIFICATIONS AND PARAMETERS ............................................................................................16 4.1 SPECIFICATIONS .............................................................................................................................. 16 4.2 INDICATING LIGHT DESCRIPTION ..................................................................................................... 18 5 OPERATION DESCRIPTIONS ........................................................................................................ 18 5.1 WEARING SOLUTIONS ..................................................................................................................... 18 5.2 PREPARATION BEFORE INITIAL USE ............................................................................................... 19 5.2.1 DOWNLOAD AND INSTALL THE APPLICATION SOFTWARE ....................................................................................19 5.2.2 USER REGISTRATION AND LOGIN ..........................................................................................................................20 5.2.3 DEVICE BINDING ................................................................................................................................................... 21 5.2.4 NETWORK CONNECTION ...................................................................................................................................... 21 5.2.5 MODE CONFIGURATION ....................................................................................................................................... 21 5.2.6 HINT MODE SETTING ............................................................................................................................................ 23 5.3 HOW TO USE .................................................................................................................................. 23 5.3.1 WEARING THE DEVICE .......................................................................................................................................... 23 5.3.2 POWER ON AND OFF ............................................................................................................................................ 26 5.3.3 FROZEN GAIT RECOGNITION AND HINT ................................................................................................................26 5.3.4 DATA COLLECTION .................................................................................................................................................28 5.3.5 DATA TRANSFERRING ............................................................................................................................................ 28 5.3.6 VIEW RESULTS ....................................................................................................................................................... 28 5.4 AFTER USING .................................................................................................................................. 29 5.4.1 END OF USE ...........................................................................................................................................................29 5.4.2 CHARGING .............................................................................................................................................................29
- 4 -
6 CLEANING AND DISINFECTION ....................................................................................................30 7 MAINTENANCE ...........................................................................................................................30 8 TROUBLESHOOTING ................................................................................................................... 30 9 PRECAUTIONS ............................................................................................................................ 31 10 CONTRAINDICATIONS ...............................................................................................................32 11 EMC INFORMATION ................................................................................................................. 33 13 LIMITED WARRANTY ................................................................................................................ 38 14 DISPOSAL ................................................................................................................................. 39 15 COPYRIGHT AND RESPONSIBILITY ............................................................................................ 39
- 5 -
Description of terms in this manual Indicates a potentially hazardous situation which, if not avoided, Warning 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 Caution or invalid operation. Information necessary to be known before using the equipment. Attention
- 6 -
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 1. INTENDED USE 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. Patients using cardiac pacemakers or other electro-stimulation devices should not use this device. 5. Do not plug or unplug the power cord with wet hands. 6. Do not give self-judgment of the data and results to give treat 7. Class 1 laser productLaser has radiation, avoid directing the laser beam towards the eye of any person. 8. Do not use this product in a place where there is a flammable gas which might cause an explosion. 9. The user must perform a safety check on the system before each use, and ensure that the system can be safely used and working properly. 10. When the patient's body is connected to other devices at the same time, the total amount of leakage current may exceed the allowable limit and pose a potential hazard to the patient. 11. Equipment or devices interconnected with this product must comply with the requirements of GB9706.1-2007 of "Medical Electrical Equipment Part 1: Safety General Requirements". Equipment or devices that have not been tested by a national inspection agency may not be interconnected with this product. aspect. 12. Although all patient contact parts have undergone bio-compatibility testing, very few people may have allergic reactions and should be discontinued for patients with allergic reactions. 13. The various accessories of this product cannot be replaced at randomly. If you need to replace it, you should use the accessories provided by the company or the same model, and standard accessories attached to the system, otherwise it may bring safety, bio-compatibility, etc. bad consequences of the 14. If the product falls unexpectedly or causes other malfunctions, it cannot be used. 15. Repairs should only be carried out by qualified service personnel designated by the manufacturer. 16. Avoid contact with wounds and scars. 17. Do not use the instrument in high-voltage equipment or in a high-static environment, as it may cause
- 7 -
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. When using this product, you must pay attention to the surrounding environment. 25. FOG patients are high-risk groups who fall, it is still necessary to take protective measures for falls while using this product. 1.Please do not use this product while charging. CAUTION 2.If the product accidentally falls into water or other liquid during charging, please unplug the power cord immediately, pick the product and wipe it in time. 3. If the product accidentally falls into the water during use, please take it out in time and use it after it is 4. Do not use this product under strong magnetic field conditions. 5. Do not disassemble or modify this product yourself. 6. If there is any problem before or during use of the device, it is recommended to consult the doctor or completely dry. manufacturer. 7. Initial use by the user may take some time to adapt to the visual hint or auditory hint of the product. Clean the attachments before using the equipment. ATTENTION 3.Review
- 8 -
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 users frozen gait, which can assist the doctor to quantitatively evaluate the patient's symptoms. Image 1 Freezing of Gait Aid System 3.2 COMPOSITION This product is mainly composed of AI center, laser, collector, earphone and application software. AI Center Laser Collector(L) Collector(R) Earphone App Image 2 Product Composition The part list of this product shows as follows:
- 9 -
Item No. Part Name Part Model Product Model GA100 Support three wearing solutions Waist, Cane, Vamp Accessories 1 2 3 4 5 6 7 8 9 10 11 12 13 14 AI Center Laser Collector (Left) Collector(Right) Earphone Waist belt Cane strap Ankle strap (Left) Ankle strap (Right) Vamp strap (Left) Vamp strap (Right) USB charging cable Charging base Hand Strap Wireless Parts Item No. 1 2 3 1 2 1 1 1 1 1 1 1 1 1 1 1 1 Part Name AI Center Laser Part Model FCC ID PU100 L100 2ACGF-GA00A 2ACGF-GA00B 2ACGF-GA00C Collector(Left,Right) SM120LSM120R Chart 1 Model Configuration Chart PU100 L100 SM120L SM120R E100
CB100
- 10 -
3.2.1 AI CENTER Image 3 AI Center NameAI Center ModelPU100 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. 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 Indicating Light Description". Earphone phone jack for inserting earphone. Hand strap hole for attaching a hand strap. Charging hole for plugging in the charging base. The tag, which contains a QR code, can be used to perform device binding operations by scanning the QR code to the application software. Chart 2 AI Center Description 1 2 3 4 5 6 7 8
- 11 -
3.2.2 LASER Image 4 Laser Description NameLaser ModelL100 Lens knob. Laser head. Part 1 2 3 4 5 6 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. Charging hole for plugging in the charging base. Chart 3 Laser Description Class 1 laser productLaser has radiation, avoid directing the laser beam towards the eye of any person. WARNING
- 12 -
3.2.3 COLLECTOR Image 5 Collector The collector is divided into two models 1NameCollector(Left) ModelSM120L 2NameCollector(Right) ModelSM120R Part 1 2 3 4 Indicator arrow for wearing direction Description Indicating Light Description". Wearing location identifier
- "R" stands for the location on the right ankle
- "L" stands for the left ankle location Charging hole for plugging in the charging base. Chart 4 Collector The indicating light shows the working status of the collector, for details, see "4.3
- 13 -
3.2.4 EARPHONE Part 1 2 3 Earplug Earphone cable Audio plug Image 6 Single hole earphone Description Chart 5 Earphone 3.2.5 ACCESSORIES Image 7 Accessories
- 14 -
3.3 WORKING CONDITIONS Conditions Environment Temperature Parameters
+5 ~ +45 Relative Humidity 10% ~ 95% (No condensation) Atmospheric Pressure 70kPa ~ 106kPa Chart 6 Working Conditions 3.4 TRANSPORTATION AND STORAGE CONDITIONS Conditions Environment Temperature Parameters
-20 ~ +60 Relative Humidity 10% ~ 95% (No condensation) Atmospheric Pressure 70kPa ~ 106kPa Chart 7 Transportation and Storage Conditions 3.5 SYMBOLS USED IN THIS DEVICE Waste Electrical and Electronic Equipment Warning Caution Attention Refer to user manual Type BF applied part DC Laser Warning Sign Single Earphone Increase Volume
- 15 -
Decrease Volume Switch Non-ionizing radiation Medical device Manufacturer Authorized representative in the European Community Chart 8 Symbols Used in This Device 4 SPECIFICATIONS AND PARAMETERS 4.1 SPECIFICATIONS Product/Part Main Parameter Description Model GA100 Main configuration: AI Center *1, laser *2, Collector*2, earphone *1;
Support two kinds of node configuration A/Bthree Identification frequency Range 4-7HzPrecision1Hz wearing solutions 1/2/3 Response time Freezing of Gait Aid Audio hint System GA100 Audio rhythm 3s Support Fast/Middle/SlowUsers can use application software to configure it Laser hint Support Laser lighting duration 6s/10s/15s/20sUsers can use application software to configure it Running time Charging time 4 h Longer than 8 h100 times/day Bluetooth Wireless 802.11 b/g/n AI Center PU100 Frequency 2400MHz 2483.5MHz standard Range Bluetoot Wireless BLE/Classic BT h standard Frequency 2400MHz 2483.5MHz
- 16 -
Range Charging 1200mAh BLE/Classic BT voltageB DC 5V 2402MHz 2480MHz attery capacity Charging time Size Weight Input Size Weight Charging Base CB100 Laser L100 Approximately 96 (L) * 68.4 (W) * 16.5 (H) (mm) 4 h 88 g DC 5V2A Approximately 200.6 (L) * 88 (W) * 40.6(H) (mm) Approximately 200 g Bluetooth Wireless BLE Frequency 2402MHz 2480MHz standard Range Battery Capacity DC 3.7V 210mAh lithium battery Laser Wavelength 514nm Power 0.316mW Size Weight Approximately 56(L)*50.9(W)*17(H) (mm) Approximately 38g Charging Voltage Charging Time DC 5V 4 h Collector SM120 Size Weight Approximately 38.9(L) * 37 (W) * 12.7 (H) (mm) Appoximately 17 g Battery Capacity DC 3.7V 210mAh lithium battery Charging Voltage Bluetoot Wireless h Standard DC 5V BLE Frequency 2402MHz 2480MHz Range Charging time Model SM120L Model SM120R 4 h Collector(Left) Collector(Right) Chart 9 Specifications and Parameters Chart
- 17 -
4.2 INDICATING LIGHT DESCRIPTION Part Light color Status description Green breathing Standby mode Green Blue flashes Charging completed/Normal Operation Uploading data or upgrading device while charging AI Center Yellow flashes four times WIFI network configuration failed / node configuration failed Yellow Red flashing Low battery status/Charging, not fully charged Hardware abnormal Green breathing Standby mode Green Charging completed/Normal Operation Yellow flashing Node not connected / sensor is invalid Collector/
Yellow Low battery status/Charging, not fully charged Laser Blue flashing Red flashing Red Upgrading Hardware abnormal The laser temperature exceeds the safe temperature, the system does not light the laser, Chart 10 Indicating light description 5 OPERATION DESCRIPTIONS 5.1 WEARING SOLUTIONS This product supports three wearing solutions
-Wearing solution 1Laser node is worn at the waist
-Wearing solution 2Laser node is worn on cane
-Wearing solution 3Laser node is worn on the shoes face
- 18 -
Image 8 Wearing Solutions Part Model Wearing Solution 1 Waist Wearing Solution 2 Cane Wearing Solution 3Vamp 1 1 1 1 1 1 1 1 1 2 1 1 1 Item No. 1 2 3 4 5 6 7 8 9 11 12 Part Name AI Center Laser Collector(Left) Collector(Right) Earphone Waist Belt Cane Strap Ankle Strap (Left) Ankle Strap (Right) Vamp Strap (Left) Vamp Strap PU100 L100 SM120L SM120R E100
1 1 1 1 1 1 1 1 Chart 11 Wearable Parts Configuration 5.2 PREPARATION BEFORE INITIAL USE Before using for the first time, please follow the steps below to prepare:
1. Choose your wearing solution 2. Download and install the application software 3. Registration and Sign in 4. Device binding 5. Device networking 6. Mode configuration 7. Use the product 5.2.1 DOWNLOAD AND INSTALL THE APPLICATION SOFTWARE The product must be used in conjunction with the mobile application software "SKYWALK". Please obtain
- 19 -
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. You can also go to http://www.gyenno.com/ to download the application. Operating Environment Hardware Configuration: RAM1 GB ROM8 GB Screen 4.7 inches Software Environment: Android 5.0 or above iOS 8.0 or above Network Conditions: Bluetooth, WiFi and Network The device does not support PC. 1. 2. The default standard font is recommended to be used on the mobile phone where application software is going to be installed to avoid incomplete screen content 5.2.2 USER REGISTRATION AND LOGIN Before using for the first time, please follow the user guide of the APP to complete user registration and login. ATTENTION
- 20 -
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. device. 2. If the bound AI center needs to be replaced, you must unbind it in the APP and then re-bind the 5.2.4 NETWORK CONNECTION Please follow the steps below to complete the WiFi network connection. 1. Plug the AI center into the charging base or charge it with the charging cable. 2. Make sure that your mobile phones Bluetooth is turned on. 3. Ensure that the AI center is in a WiFi environment, open SKYWALK APP and follow the instruction of Network connection to complete the connection. 4. If the connection is successful, Connection successful will pop-up on SKYWALK APP. 5. If the connection fails, Connection failed will pop-up on SKYWALK APP, please follow the guide on APP to reconnect. ATTENTION 1. The device mus bt bound with your phone before configuring the WiFi connection. 2. AI Center should be in normal charging status while configuring the WiFi connection. 3. The WiFi network connection should be reconfigured if the wireless environment changes. 4. The device only supports 2.4G WiFi connection. 5.2.5 MODE CONFIGURATION Before using the device, you must configure the nodes and AI center in advance. The product supports three configuration modes:
- 21 -
AI center Laser nodes Collector nodes Waist/Cane Mode Configuration Shoe Mode Configuration 1 1 1 2 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. Plug the corresponding nodes and AI center into the charging base. 3. Make sure that mobile phones bluetooth is on. 4. Open SKYWALK in your mobile phone and follow the Mode Configuration guide to complete the node configuration. APP guide to reconfigure. 5. If the mode configuration is successful, Configuration Successful will pop-up on SKYWALK APP. 6. If the mode configuration fails, Configuration failed will pop-up on SKYWALK APP. Please follow the ATTENTION 1. When configuring the mode, you must ensure that the AI center and nodes are in normal charging 2. If you need to replace the configured AI compute center or node, the mode configuration must be state. reconfigured. 3. If you need to switch other node configuration, the node configuration must be reconfigured. 4. Charge the nodes according to the number of nodes in wearing solution during mode configuration. Do not charge the nodes which are not going to be configured simultaneously .
- 22 -
5.2.6 HINT MODE SETTING The device has two hint modes:
vision. 1 Laser hint: laser line is projected in front of the user's walking, guiding the user to walk normally by 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. User can set the parameters in the APP:
1) The duration of laser and audio hint after each trigger;
2) Beat rhythm of the audio hint: fast/medium/slow. 1. Do not use binaural earphones when using audio hint. Warning 5.3 HOW TO USE 5.3.1 WEARING THE DEVICE
- 23 -
Users need to select a wearing mode, take out the corresponding parts according to the selected wearing mode and wear the device according to the following steps of the chosen wearing mode:
1. WEARING MODE 1(WAIST) 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 -
3. WEARING MODE 3(SHOE) Wearing mode 3 (shoes) Wear the laser node on the shoes Image 23 Wearing mode 2 ATTENTION
- 25 -
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. 5.3.3 FROZEN GAIT RECOGNITION AND HINT AUTOMATIC RECOGNITION AND HINT After the device is turned on normally, it can be used while walking. 1. Real-time detection and automatic analysis to recognize user's walking gait;
2. When the frozen gait occurs, laser hint, audio hint or both hints will be triggered according to the system setting;
3. The device will not give any hint if user is walking normally and no frozed gait occurs. 4. The duration of each hint is based on the system setting. MANUAL HINT At normal operation status, short press AI centers power button to trigger manual hint. Laser hint, audio hint, or both hints will be triggered according to the system setting, the default hint duration is 30s. Short press AI centers power button to turn off manual hint. LASER LINE ADJUSTMENT
- 26 -
The most suitable position of laser line to project on the ground is 20 to 50 cm in front of the user's foot;
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 Rotate the lens knob to control the direction of the laser line projected on the ground so that the laser line is parallel to your toe, as shown in Image 26:
Image 26 Laser node WARNINGS OF LASER HINT Warning
- 27 -
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. environment. 2. Users should not only attention the audio rhythm, but also pay attention to the surrounding The device automatically records the user's gait data while using, and the gait data is automatically stored in 5.3.4 DATA COLLECTION the AI center. 5.3.5 DATA TRANSFERRING All data stored in the device will be transferred while charging. 1. Please charge the AI center before transferrring data. 2. The AI center will automatically access the network through WiFi and upload data to the cloud while charging. 3. Data transfer will start once a wireless connection is successfully set up. When transferring data, the indicating light of AI center indicator will flash in blue and when the process is completed, the indicating light stays in yellow(charging) or green(charged). 5.3.6 VIEW RESULTS Open the APP, select Data, and view the frozen gait data in the interface, including the statistics of the daily activity duration, the number of frozen gait occurrences, the start and end time of the frozen gait, the average duration of the frozen gait, and the duration distribution of the frozen gait.
- 28 -
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. Caution 2. The measurement is terminated. The measurement time is insufficient or its not an actual 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. measurement. 5.4 AFTER USING 5.4.1 END OF USE 5.4.2 CHARGING Image 27 Charging base Name: Charging base, Model: CB100 Description Serial 1 2 3 4 AI center charging port Laser node charging port Collector node charging port Charging hole for connecting the charging cable. Chart 3 Charging base description When the battery of AI center or node is low, the indicating light stays in yellow which means it needs to be charged as soon as possible. Place the AI center and nodes individually or completely in the corresponding charging port of the
- 29 -
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. The fabric, PU leather and buckle parts of the strap can be washed with a brush, detergent and clean water. The metal part of the strap should never be submerged in water to avoid corrosion, it can be wiped and cleaned with antibacterial tissue or cotton cloth soaked with alcohol. Remove the hand strap and wash it with a mild detergent, then rinse it off. 7 MAINTENANCE The device consists of sophisticated mechanical parts. Performance and service life of this device may be significantly reduced if under long-term magnetic interference. Power off the device after using. Any part of the device is not waterproof, do not splash water on it or submerge it into water washed or drenched. Do not place or store the device near fire or heat articles. The device should be cleaned in time after use. Please avoid dropping or impacting the device at any time. Do not forcefully pull, press or twist the unit or components. The device should be charged in time. It should be fully charged and stored when its not in use for a long time. It should be charged every one to two months and stored in a cool or dry environment in order to avoid moisture and exposure. 8 TROUBLESHOOTING PROBLEMS Possible Causes and Troubleshooting Unable to bind with APP 1The network signal is weak. Please move to a place where the signal is strong and try again.
- 30 -
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 2. The device exits the connecting state due to timeout. Please try network again according to the "Network connection" section. 3. The wireless network signal is weak. Please move to a location where the signal is stronger and try again. 1. The device is not used as required. Please check if the product is properly worn. Unable to intervene when 2. The connection signal between AI center and nodes is weak. a frozen gait occurs Observe the status of the node indicator and check if it is under normal operation status of green. according to the Mode Configurationsection If not, please re-network 1. The device is not bound to the APP. Please try again according to the "Device Binding" section. Unable to transmiss data 2. The wireless network signal is weak. Please move to a place where the signal is stronger and try again. 1. Not charging properly Check if the charging cable or charging base is properly Unable to charge connected. 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. Make sure that the device is fully charged before use. When the battery is low, stop using the device and charge it as soon as possible. Please follow the instruction to use the device. Do not wash the straps by any washing machine, it can only be washed by hand. Do not remove the QR code on the product.
- 31 -
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 doctors advice.
- 32 -
11 EMC INFORMATION Guidance and manufactures 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 guidance The device uses RF energy only for their internal function. Therefore, their RF Group 1 emissions are very low and are not likely to cause any interference in nearby electronic device. Harmonic emissions The device is suitable for use in all establishments, other than domestic IEC/EN 61000-3-2 establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes. RF emissions CISPR 11 RF emission CISPR 11 Class B N/A Voltage fluctuations/
flicker emissions N/A IEC/EN 61000-3-3 NOTE The EMISSIONS characteristics of the device make it suitable for use in industrial areas and hospitals (CISPR 11 class A). If it is used in a residential environment (for which CISPR 11 class B is normally required) the device might not offer adequate protection to radio-frequency communication services. The user might need to take mitigation measures, such as relocating or re-orienting the device.
- 33 -
Guidance and manufactures 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 Electrostatic discharge (ESD) 8 kV contact 8 kV contact tile. If floor are covered with synthetic IEC/EN 61000-4-2 15 kV air 15 kV air material, the relative humidity should be at Floors should be wood, concrete or ceramic Electrical fast transient/burst 2 kV for power supply IEC/EN 61000-4-4 lines Surge 1 kV for line to line IEC/EN 61000-4-5 2 kV for line to ground N/A N/A least 30%. N/A N/A 30 A/m 30 A/m Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment. Power frequency
(50/60Hz) magnetic field IEC/EN 61000-4-8 Voltage dips, short interruptions and voltage variations on power supply input lines IEC/EN 61000-4-11
<5 % UT>95% dip in UT for 0.5 cycle 40 % UT60% dip in UTfor 70 % UT30% dip in UTfor
<5 % UT>95% dip in UT 5 cycles 25 cycles for 5 s NOTE UT is the a.c. mains voltage prior to application of the test level. N/A N/A
- 34 -
Guidance and manufactures 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 3 Vrms Conducted RF 150 kHz to 80 MHz IEC/EN 61000-4-6 6 Vrms in ISM bands between 0,15 MHz and 80 MHz Portable and mobile RF communications device should be used no closer to any part of the device, including cables, than the recommended N/A separation distance calculated from the equation applicable to the frequency of the transmitter. Recommended separation distance 150KHz to 80MHz
= 1.2 80 MHz to 800 MHz
= 1.2 800 MHz to 2.7 GHz
= 2.3 d=6
/E at RF wireless communications device bands (Portable RF communications device (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of the device, including cables specified by the Where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in meters
(m). 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 device marked with the following symbol:
3 V/m 3 V/m manufacturer). Radiated RF 80 MHz to 2.7 GHz 80 MHz to 2.7 GHz IEC/EN 61000-4-3 See table 1 Comply with table 1 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.
- 35 -
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. If the measured field strength in the location in which the device is used exceeds the applicable RF compliance level above, the device should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the device. b. Over the frequency range 150 kHz to 80MHz, field strengths should be less than 3V/m. c. The ISM (industrial, scientific and medical) bands between 0,15 MHz and 80 MHz are 6,765 MHz to 6,795 MHz; 13,553 MHz to 13,567 MHz; 26,957 MHz to 27,283 MHz; and 40,66 MHz to 40,70 MHz. The amateur radio bands between 0,15 MHz and 80 MHz are 1,8 MHz to 2,0 MHz, 3,5 MHz to 4,0 MHz, 5,3 MHz to 5,4 MHz, 7 MHz to 7,3 MHz, 10,1 MHz to 10,15 MHz, 14 MHz to 14,2 MHz, 18,07 MHz to 18,17 MHz, 21,0 MHz to 21,4 MHz, 24,89 MHz to 24,99 MHz, 28,0 MHz to 29,7 MHz and 50,0 MHz to 54,0 MHz. Test specifications for enclosure port immunity to RF wireless communications device Test frequency
(MHz) Band a)
(MHz) Service a) Modulation b) power 380-390 TETRA 400 Pulse modulation b) 18 Hz 430-470 GMRS 460, FRS 460 FM c) 5 kHz deviation Maximum Test Distance
(m) 0,3 0,3 frequency
(MHz) 27 28
(W) 1,8 2 704-787 LTE Band 13, 17 Pulse modulation b) 217 Hz 0,2 0,3 9 800-960 iDEN 820, CDMA 850, LTE Pulse modulation b) 18 Hz 2 0,3 28 1845 1700-1990 1900; DECT; LTE Band 1, 3, 4, Pulse modulation b) 217 Hz 0,3 28 2450 2400-2570 Pulse modulation b) 217 Hz 0,3 28 2 2 GSM 800/900, TETRA 800, GSM 1800; CDMA 1900; GSM Band 5 25; UMTS Bluetooth, WLAN, 802.11 b/g/n, RFID 2450, LTE Band 7
- 36 -
385 450 710 745 780 810 870 930 1720 1970 5240 5785 5500 5100-5800 WLAN 802.11 a/n Pulse modulation b) 217 Hz 0,2 0,3 9 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. c) As an alternative to FM modulation, 50 % pulse modulation at 18 Hz may be used because while it does not represent actual modulation, it would be worst case. Chart 13 EMC Compliance Statement B Recommended Separation Distances Between Portable and Mobile RF Communications Device and This Device The device is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the device can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications device (transmitters) and the device as recommended below, according to the maximum output power of the communications device. Rated Maximum Output Power of Transmitter
(W) 0.01 0.1 1 10 100 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2.5 GHz
= 1.2
= 1.2
= 2.3 0.12 0.38 1.2 3.8 12 0.12 0.38 1.2 3.8 12 0.23 0.73 2.3 7.3 23 For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be estimated 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. NOTE 1 At 80 MHz and 800 MHz, the separation distance for 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. Chart 14 Recommended Sepearation Distance of Electromagnetic Interference
- 37 -
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. FCC RF Radiation Exposure StatementModel: SM120L& L100:
1. This Transmitter must not be co-located or operating in conjunction with any other antenna or transmitter. environment. 2. This equipment complies with RF radiation exposure limits set forth for an uncontrolled The device has been evaluated to meet general RF exposure requirement. The device can be used in portable exposure condition without restriction. FCC RF Radiation Exposure StatementModel: PU100:
This radio is designed for and classified as General population/uncontrolled Use, the guidelines are based on standards that were developed by independent scientific organizations through periodic and thorough evaluation of scientific studies. The standards include a substantial safety margin designed to assure the safety of all persons regardless of age or health. Body and limbs operation; this device was tested for typical body and limbs operations kept 0mm for body worn. To maintain compliance with RF exposure requirements, use accessories that maintain a 0mm for body worn. 13 LIMITED WARRANTY the date of purchase. AI center and all nodes of the device is warranted to be free from detects within 12 months starting from Any part of the device, including attachments and accessories, is not allowed to be repaired by unspecified Damage caused by the failure to use in abnormal environment or without following the user manual. maintenance. One of the following occurs is not eligible for warranty claim:
Damaged caused by disassembling or modifing on customers own Damage caused by unspecified maintenance by manufacturer. Damaged caused by exceeding the specified conditions of use. Damage caused by improper use or transportation. Manufacturing label being replaced or removed. Repairing services out of the warranty will be charged as required.
- 38 -
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. This manual is subjected to be a reference for operating and maintaining the equipment.
- 39 -
1 | FCC Long Term Only Confidentiality Request Rev4.1 | Cover Letter(s) | 86.27 KiB | July 25 2022 |
GYENNO Technologies CO., LTD. Office of Engineering Technology Federal Communications Commission 7435 Oakland Mills Road Columbia, MD 21046 Subject; Request for Long Term Confidentiality Date: 2022-07-18 FCC ID: 2ACGF-GA00A To Whom It May Concern, Pursuant to the provisions of the Commissions rules Title 47 Sections 0.457 and 0.459, we are requesting the Commission to withhold the following attachment(s) as confidential documents from public disclosure indefinitely. These documents contain detailed system and equipment descriptions and are considered as proprietary information in operation of the equipment. The public disclosure of these documents might be harmful to our company and would give competitors an unfair advantage in the market. It is our understanding that all measurement test reports, FCC ID label format and correspondence during the certification review process cannot be granted as confidential documents and this information will be available for public review once the grant of equipment authorization is issued. Schematic Diagram Block Diagram Operational Description Sincerely, Signature:
Name: Tom Zhang Title: Process Manager
1 | LetterofAuthorizationRev2.0 | Cover Letter(s) | 121.09 KiB | July 25 2022 |
Letter of Authorization Company: GYENNO Technologies CO., LTD. Address:
A805 A806,Shenzhen Institute of Industry-University-
Research of HUST,No.9 Yuexing 3rd Road, Science Park,Nanshan DistrictShenzhen,518000 P.R.China. Product Name: AI Center Model Number: PU100 FCC Identifier: 2ACGF-GA00A We authorize MiCOM Labs Inc, 575 Boulder Court, Pleasanton, California 94566, USA, to act on our behalf on all matters concerning the above named equipment. Any individual within MiCOM Labs is authorized to act on our behalf and take action on the application. We declare that MiCOM Labs Inc, 575 Boulder Court, Pleasanton, California 94566, USA, is allowed to forward all information related to the approval project to the Federal Communication Commission and to discuss any issues concerning the approval application. Any and all acts carried out by MiCOM Labs on our behalf shall have the same effect as acts of our own. Name: Tom Zhang Date: 2022-07-18 Title: Process Manager
frequency | equipment class | purpose | ||
---|---|---|---|---|
1 | 2022-07-25 | 2412 ~ 2462 | DTS - Digital Transmission System | Original Equipment |
app s | Applicant Information | |||||
---|---|---|---|---|---|---|
1 | Effective |
2022-07-25
|
||||
1 | Applicant's complete, legal business name |
GYENNO Technologies CO., LTD.
|
||||
1 | FCC Registration Number (FRN) |
0023549199
|
||||
1 | Physical Address |
A805 A806, Shenzhen Institute of IUR of HUST, No.9Yuexing3rd Road,Science Park, Nanshan District
|
||||
1 |
A805 A806, Shenzhen Institute of IUR of HUST
|
|||||
1 |
Shenzhen, N/A
|
|||||
1 |
China
|
|||||
app s | TCB Information | |||||
1 | TCB Application Email Address |
c******@micomlabs.com
|
||||
1 | TCB Scope |
A4: UNII devices & low power transmitters using spread spectrum techniques
|
||||
app s | FCC ID | |||||
1 | Grantee Code |
2ACGF
|
||||
1 | Equipment Product Code |
GA00A
|
||||
app s | Person at the applicant's address to receive grant or for contact | |||||
1 | Name |
T****** Z********
|
||||
1 | Title |
Process Manager
|
||||
1 | Telephone Number |
+86 7******** Extension:
|
||||
1 | Fax Number |
+86 7********
|
||||
1 |
z******@gyenno.com
|
|||||
app s | Technical Contact | |||||
1 | Firm Name |
GYENNO Technologies CO., LTD.
|
||||
1 | Physical Address |
China
|
||||
1 |
z******@gyenno.com
|
|||||
app s | Non Technical Contact | |||||
n/a | ||||||
app s | Confidentiality (long or short term) | |||||
1 | Does this application include a request for confidentiality for any portion(s) of the data contained in this application pursuant to 47 CFR § 0.459 of the Commission Rules?: | Yes | ||||
1 | Long-Term Confidentiality Does this application include a request for confidentiality for any portion(s) of the data contained in this application pursuant to 47 CFR § 0.459 of the Commission Rules?: | No | ||||
if no date is supplied, the release date will be set to 45 calendar days past the date of grant. | ||||||
app s | Cognitive Radio & Software Defined Radio, Class, etc | |||||
1 | Is this application for software defined/cognitive radio authorization? | No | ||||
1 | Equipment Class | DTS - Digital Transmission System | ||||
1 | Description of product as it is marketed: (NOTE: This text will appear below the equipment class on the grant) | AI Center | ||||
1 | Related OET KnowledgeDataBase Inquiry: Is there a KDB inquiry associated with this application? | No | ||||
1 | Modular Equipment Type | Does not apply | ||||
1 | Purpose / Application is for | Original Equipment | ||||
1 | Composite Equipment: Is the equipment in this application a composite device subject to an additional equipment authorization? | No | ||||
1 | Related Equipment: Is the equipment in this application part of a system that operates with, or is marketed with, another device that requires an equipment authorization? | No | ||||
1 | Grant Comments | Power listed is the maximum conducted output power. SAR compliance for body-worn operating configurations is limited to the specific configurations tested for this filing. Body-worn operations are restricted to belt-clips, holsters or similar accessories that have no metallic component in the assembly and must provide at least 0 mm separation between the device and the body of the user. End-users must be informed of the body-worn operating requirements for satisfying RF exposure compliance. The highest reported SAR for body-worn, Limbs and simultaneous SAR accessory are 0.56W/kg,0.25W/kg and 0.60 W/kg respectively. | ||||
1 | Is there an equipment authorization waiver associated with this application? | No | ||||
1 | If there is an equipment authorization waiver associated with this application, has the associated waiver been approved and all information uploaded? | No | ||||
app s | Test Firm Name and Contact Information | |||||
1 | Firm Name |
Shenzhen Huatongwei International Inspection Co.,
|
||||
1 | Name |
J****** L******
|
||||
1 | Telephone Number |
+86-7********
|
||||
1 |
q******@szhtw.com.cn
|
|||||
Equipment Specifications | |||||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Line | Rule Parts | Grant Notes | Lower Frequency | Upper Frequency | Power Output | Tolerance | Emission Designator | Microprocessor Number | |||||||||||||||||||||||||||||||||
1 | 1 | 15C | 2402 | 2480 | 0.0023 | ||||||||||||||||||||||||||||||||||||
1 | 2 | 15C | 2412 | 2462 | 0.1205 |
some individual PII (Personally Identifiable Information) available on the public forms may be redacted, original source may include additional details
This product uses the FCC Data API but is not endorsed or certified by the FCC