Gyenno Freezing of Gait Aid System Installation and operation manual

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User Manuals
Freezing of Gait Aid System
GA100-IFU-EN
V1.1

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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
V1.1
Update the content according to the requirements of external
inspection agencies
2022-05-17
Qianyu Liu

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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.:[phone]
Email: servi[email protected]
Website: www.gyenno.com

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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

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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

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Description of terms in this manual
Warning
Indicates a potentially hazardous situation which, if not avoided,
could result in death or serious injury.
Caution
Indicates a potentially hazardous situation which, if not avoided,
may result in invalid data collecting ,damage to the equipment
or invalid operation.
Attention
Information necessary to be known before using the
equipment.

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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. 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 product，Laser 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.
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
aspect.
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

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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.
CAUTION
1.Please do not use this product while charging.
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
completely dry.
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
manufacturer.
7. Initial use by the user may take some time to adapt to the visual hint or auditory hint of the product.
ATTENTION
Clean the attachments before using the equipment.
3.Review

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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
3.2 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:

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Item No.
Part Name
Part Model
Product Model
GA100
Support three wearing solutions
（Waist, Cane, Vamp）
1
AI Center
PU100
1
2
Laser
L100
2
3
Collector (Left)
SM120L
1
4
Collector(Right)
SM120R
1
5
Earphone
E100
1
Accessories
6
Waist belt
-
1
7
Cane strap
-
1
8
Ankle strap (Left)
-
1
9
Ankle strap (Right)
-
1
10
Vamp strap (Left)
-
1
11
Vamp strap (Right)
-
1
12
USB charging cable
-
1
13
Charging base
CB100
1
14
Hand Strap
-
1
Wireless Parts
Item No.
Part Name
Part Model
FCC ID
1
AI Center
PU100
2ACGF-GA00A
2
Laser
L100
2ACGF-GA00B
3
Collector(Left,Right)
SM120L，SM120R
2ACGF-GA00C
Chart 1 Model Configuration Chart

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3.2.1 AI CENTER
Image 3 AI Center
Name：AI Center Model：PU100
Part
Description
1
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.
2
Volume button "+"
- Increase the volume.
3
Volume button"-"
- Decrease the volume .
4
The indicating light shows the working status of the AI center. For details, see "4.3
Indicating Light Description".
5
Earphone phone jack for inserting earphone.
6
Hand strap hole for attaching a hand strap.
7
Charging hole for plugging in the charging base.
8
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

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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.
Chart 3 Laser Description
WARNING
Class 1 laser product，Laser has radiation, avoid directing the laser beam towards the eye of any person.

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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
1
Indicator arrow for wearing direction
2
The indicating light shows the working status of the collector, for details, see "4.3
Indicating Light Description".
3
Wearing location identifier
- "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.
Chart 4 Collector

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3.2.4 EARPHONE
Image 6 Single hole earphone
Part
Description
1
Earplug
2
Earphone cable
3
Audio plug
Chart 5 Earphone
3.2.5 ACCESSORIES
Image 7 Accessories

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3.3 WORKING CONDITIONS
Conditions
Parameters
Environment
Temperature
+5 ℃~ +45 ℃
Relative Humidity
10% ~ 95% (No condensation)
Atmospheric Pressure
70kPa ~ 106kPa
Chart 6 Working Conditions
3.4 TRANSPORTATION AND STORAGE CONDITIONS
Conditions
Parameters
Environment
Temperature
-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
Warning
Caution
Attention
Refer to user manual
Waste Electrical and Electronic Equipment
Type BF applied part
DC
Laser Warning Sign
Single Earphone
Increase Volume

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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
Freezing of Gait Aid
System GA100
Model GA100
Main configuration: AI Center *1, laser *2, Collector*2,
earphone *1;
Support two kinds of node configuration A/B，three
wearing solutions 1/2/3
Identification frequency
Range 4-7Hz，Precision±1Hz
Response time
≤3s
Audio hint
Support
Audio rhythm
Fast/Middle/Slow
（Users can use application software to
configure it）
Laser hint
Support
Laser lighting duration
6s/10s/15s/20s（Users can use application software to
configure it）
Running time
Longer than 8 h（100 times/day，）
Charging time
≤4 h
AI Center
PU100
Bluetooth
Wireless
standard
802.11 b/g/n
Frequency
Range
2400MHz ～2483.5MHz
Bluetoot
h
Wireless
standard
BLE/Classic BT
Frequency
2400MHz ～2483.5MHz

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Range
Charging
voltageB
attery
capacity
1200mAh
BLE/Classic BT
DC 5V
2402MHz ～2480MHz
Charging time
≤4 h
Size
Approximately 96 (L) * 68.4 (W) * 16.5 (H) (mm)
Weight
88 g
Charging Base
CB100
Input
DC 5V2A
Size
Approximately 200.6 (L) * 88 (W) * 40.6(H) (mm)
Weight
Approximately 200 g
Laser
L100
Bluetooth
Wireless
standard
BLE
Frequency
Range
2402MHz ～2480MHz
Battery Capacity
DC 3.7V 210mAh lithium battery
Laser
Wavelength
514nm
Power
0.316mW
Size
Approximately 56(L)*50.9(W)*17(H) (mm)、
Weight
Approximately 38g
Charging Voltage
DC 5V
Charging Time
≤4 h
Collector
SM120
Size
Approximately 38.9(L) * 37 (W) * 12.7 (H) (mm)
Weight
Appoximately 17 g
Battery Capacity
DC 3.7V 210mAh lithium battery
Charging Voltage
DC 5V
Bluetoot
h
Wireless
Standard
BLE
Frequency
Range
2402MHz ～2480MHz
Charging time
≤4 h
Model SM120L
Collector(Left)
Model SM120R
Collector(Right)
Chart 9 Specifications and Parameters Chart

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4.2 INDICATING LIGHT DESCRIPTION
Part
Light color
Status description
AI Center
Green breathing
Standby mode
Green
Charging completed/Normal Operation
Blue flashes
Uploading data or upgrading device while charging
Yellow flashes four times
WIFI network configuration failed / node configuration
failed
Yellow
Low battery status/Charging, not fully charged
Red flashing
Hardware abnormal
Collector/
Laser
Green breathing
Standby mode
Green
Charging completed/Normal Operation
Yellow flashing
Node not connected / sensor is invalid
Yellow
Low battery status/Charging, not fully charged
Blue flashing
Upgrading
Red flashing
Hardware abnormal
Red
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 1（Laser node is worn at the waist）
-Wearing solution 2（Laser node is worn on cane）
-Wearing solution 3（Laser node is worn on the shoes face）

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Image 8 Wearing Solutions
Item
No.
Part Name
Part
Model
Wearing Solution 1
（Waist）
Wearing Solution 2
（Cane）
Wearing Solution
3（Vamp）
1
AI Center
PU100
1
1
1
2
Laser
L100
1
1
2
3
Collector(Left)
SM120L
1
1
╳
4
Collector(Right)
SM120R
1
1
╳
5
Earphone
E100
1
1
1
6
Waist Belt
-
1
╳
╳
7
Cane Strap
-
╳
1
╳
8
Ankle Strap (Left)
-
1
1
╳
9
Ankle Strap (Right)
-
1
1
╳
11
Vamp Strap (Left)
-
╳
╳
1
12
Vamp Strap
-
╳
╳
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

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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: RAM≥1 GB
ROM≥8 GB
Screen≥4.7 inches
Software Environment: Android 5.0 or above
iOS 8.0 or above
Network Conditions: Bluetooth, WiFi and Network
ATTENTION
1. The device does not support PC.
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.