GYENNO TC200 Hand Tremor Data Collector User Manual

GYENNO TC200 Hand Tremor Data Collector

Version: TC200-EN-V3.0

DEFINITIONS

• 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.
• NOTICE: Information necessary to be known before using the equipment.

INTENDED USE

The hand tremor data collector is used to collect hand tremor data of user with Parkinson’s Disease, Parkinson’s Syndrome, Essential Tremor, or other physical disabilities. It can also be used as assistive equipment to eat.

SAFETY INFORMATION

WARNING

1. Do not place or store the equipment near fire or heat articles.
2. Do not use a damaged charging cable or socket.
3. Do not use the equipment if a pacemaker or electrical stimulation equipment is adopted.
4. Users allergic to medical rubber are not commended to use this equipment.
5. Do not plug or unplug the charging cable when hands are wet.
6. Do not make self-diagnose based on data collected by the equipment.
7. Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in improper operation. If such use is necessary, this equipment and the other equipment should be observed to verify that they are operating normally.
8. Use of accessories, transducers and cables other than those specified or provided by the manufacturer of this equipment could result in increased electromagnetic emissions or decreased electromagnetic immunity of this equipment and result in improper operation.

CAUTION

1. Do not immerse the equipment except for attachments into any kind of liquid.
2. Do not use the equipment while charging.
3. In case the equipment falls into liquid while charging, unplug the cable immediately and wipe the equipment.
4. The attachments should not be disinfected with high temperature or microwaved.
5. The handle should not be washed in dishwasher, disinfected with high temperature or microwaved.
6. Do not use this equipment in a strong magnetic environment.
7. Do not exceed the maximum load of the equipment.
8. Do not dismount or attempt to repair the unit or components.

NOTICE
Clean the attachments before using the equipment.

KNOW YOUR UNIT

The equipment can collect tremor data of user by built-in sensors and transfer the data via WIFI. It can also detect and offset shaking of hand to help user eat smoothly.

Components **

**

Handle

Handle Rear View

1

| Power button
Short press: Turn on or off the equipment
Long press for 5 seconds: Enter Wi-Fi configuration mode
2| Indicating light to identify different status
3| Fixing screw
4| Charging cable jack
5| Connecting dock for hand strap

Attachment Spoon Attachment

SYMBOLS USED

SPECIFICATIONS

Dimensions|

Approx. 233 (L) 52.5 (W) 31.5 (H) (mm)

---|---
Total Weight| ≈ 155 g
Spoon Weight| ≈ 6.7 g
Fork Weight| ≈ 5.4 g
Measurement Range| Frequency: 3 Hz to 12 Hz
Amplitude: 6 mm to 100 mm
Resolution| Frequency: 0.1 Hz
Amplitude: 1 mm
Accuracy| Frequency: 10% of reading Amplitude: ±1 mm or 10% of reading
Operational Conditions| Temperature: 41 ℉ to 104 ℉ (+5 ℃ to +40 ℃)
Humidity: 10% to 85% RH
Air pressure: 700 hPa to 1060 hPa
Transportation and Storage Conditions| Temperature: -4 ℉ to 140 ℉ (-20 ℃ to +60 ℃)
Humidity: 10% to 93% RH
Air pressure: 700 hPa to 1060 hPa
Power Source| 5V 1A
Working Time| 3 days (3 meals per day or 30 records per day)
Charging Time| ≤ 3hours
Maximum Load| ≈ 15 g
WiFi| Protocol| 802.11 b/g/n
Frequency Range| 2400 MHz to 2483.5 MHz
Antenna Type| Built-in antenna

INDICATING LIGHT DESCRIPTION

NOTICE

1. If the indicating light alternates in red and yellow, the equipment is charging and not connected to Wi-Fi.
2. If the indicating light alternates in green and yellow, the equipment is fully charged and not connected to Wi-Fi.

DOWNLOAD MOBILE APPLICATION

Please search for “GYENNO SPOON” in the appropriate mobile application store, download and install it.

You can also visit www.gyenno.com/spoon2 for downloading the mobile application “GYENNO SPOON”. Open the app on your smartphone and follow the Wi-Fi configuration instructions.

BEFORE USING

Attachments Installation

The attachments will adhere to the handle by magnetic force when the attachments are placed near the handle as shown below.

How to Hold the Equipment

Make sure the attachment is firmly connected to the handle before using. It is recommended to hold the equipment as shown below.
For users with severe tremor or stiff, please put on the hand strap before using to avoid dropping the equipment.

CAUTION
Please always keep the twist button towards human body while using the equipment to ensure validity of data collecting and assisting to eat.

Power On and Off

Short press the power button to turn on or off the equipment. When the equipment is standby, the indicating light breaths in green.

NOTICE
The equipment will automatically turn off if it had not been working for 5 minutes.

TAKING A MEASUREMENT

When the equipment is on and once it detects tremor, data collecting will start. The indicating light breaths in blue.

The data collecting process takes a few minutes (measurement period), when it is completed, the indicating light breaths in green. Each measurement period the equipment exports a measurement result including frequency and amplitude.

NOTICE

1. Reboot the equipment before taking the next measurement.
2. Do not power off or put down the equipment before the measurement completes.

Data Transferring

All data stored in the equipment will be transferred while charging. To transfer data, please connect the equipment with power supply by the charging cable.

The equipment will automatically retry the saved latest wireless connection in a scanning window. If successfully connected, the indicating light flashes in blue for a while. If failed, the indicating light flashes in yellow.
If Wi-Fi connects failed, please follow the instructions in “GYENNO SPOON” to retry.
Data transfer will start once a wireless connection is successfully set up. When transferring data, the indicating light flashes in blue and when the process is completed, the indicating light stays in red (charging) or green (charged).

View the Measurement

The measurement results, including the frequency (Hz) and amplitude (mm), can be viewed in “GYENNO SPOON”.

NOTICE

If no measurement results are shown, it may be caused by:

1. None or incomplete data transfer due to Wi-Fi connection problems.
2. The measurement is terminated.

ASSIST TO EAT

Shaking Offset

Once the equipment detects tremors, the internal motors actively offset the shaking to keep stable.

Twist Function

The equipment offers a twist function to help the user eat noodles, spaghetti, pasta, etc. Install the fork before using the twist function, press and hold the button to start twisting, loose the button after twisting the noodles, the fork will then reset to horizontal.

AFTER USING

Attachments Uninstallation

Please power off and uninstall the attachments after using. The handle should be placed horizontally. It is suggested that both the handle and attachments should be cleaned each time after using.

Charging

If the indicating light breaths in red, the equipment can still work for approximately 10 minutes. In order to protect the mechanic parts, please charge the equipment as soon as possible.
To start charging, plug in the charging cable and connect to power. Keep the equipment horizontal while charging. The indicating light stays in red while charging and it turns to green when charged.

NOTICE

1. Adapter specification: 5V 1A.
2. To avoid pollution, please properly dispose the equipment and charging cable according to local laws and rules related.

CLEANING AND DISINFECTION

Attachments

NOTICE
The attachments should be cleaned before the first use.
Please uninstall the attachments from the handle before cleaning. The attachments are suggested to wash with utensil detergent and water, they can also be cleaned in the dishwasher. Wipe the attachments with dry cloth. Do not submerge the attachments into detergent contains corrosive ingredient.
If low-level disinfection is required, use alcohol solution (ethanol (75%), isopropyl (70%), e.g.), or disinfect it with ozone, ultraviolet rays, high temperature disinfection is not permitted.

Soft Sleeve

To clean the soft sleeve, use a cotton swab with warm water and mild detergent, and dry it with a clean cotton swab. Never clean it with toothpicks, tweezers, or anything sharp.
If low-level disinfection is required, use a cotton swab with alcohol solution (ethanol (75%), isopropyl (70%), e.g.), and dry it with a clean cotton swab.

Handle and Cover

The handle should never be submerged in water or cleaned in the dishwasher. Wipe the handle or cover clean with antibacterial wipes or a cloth with alcohol solution (ethanol (75%), isopropyl (70%), e.g.) and dry it with a clean, soft cloth.
The cover can be cleaned with a sponge, dishwashing detergent, and clean water, and can also be cleaned in the dishwasher. After cleaning, dry it with a clean, soft cloth. Do not use corrosive solutions to wipe or clean.

Hand Strap

Please put off the hand strap from the handle and wash it with a mild detergent, then rinse it off.

MAINTENANCE

1. The attachment should be uninstalled from the handle before cleaning. Use a small portion of utensil detergent and water to wash.
2. The attachment should not be submerged into detergent contains corrosive ingredient.
3. Any part of the handle is not waterproof, do not splash water on the handle or submerge it into water. Wipe and clean the handle with antibacterial tissue or cotton cloth soaked with alcohol.
4. Power off the equipment before installing or uninstalling the attachment or accessories, or after using.
5. Do not place or store the equipment near fire or heat articles.
6. This equipment consists of motors and sophisticated mechanical parts. Performance and service life of this equipment may be significantly reduced if under Long-term magnetic interference.
7. Please avoid dropping or impacting the equipment at any time.
8. Do not forcefully pull, press, or rotate the unit or components. Do not press other objects with the equipment.
9. The equipment is only used for hand tremor data collecting and an assistive tool for eating. Do not use for other purposes.
10. The service life of this equipment is 3 years (3 meals per day) or 50000 measurements (3 minutes per time).

TROUBLESHOOTING

Please register the equipment follow the instructions in “GYENNO SPOON”.
The equipment is not connected to the Wi-Fi. Please configure the Wi-Fi follow the instructions in “GYENNO SPOON”. Insufficient time for measurement
Please refer to the section “Taking a measurement”
The rubber sleeve breaks| Please stop using the equipment and contact GYENNO Service.
Unable to charge
Unable to offset shaking
Unable to twist
Others

PRECAUTIONS

1. It is suggested to use this equipment independently at the first time to avoid worse tremor caused by the anxiety and nervous since the users may have difficulties on daily eating and being taken care of.
2. It is suggested to proactively adjust holding gestures and ways of sending food to mouth at the beginning of adopting the equipment. The best way of using the equipment will come after some time.
3. A big and shallow bowl helps when using the equipment as an assistive tool to eat.
4. It may take several days for a user to use the equipment well. Please keep using for at least a week to get used to this new way of eating.
5. Do not apply any kind of forces to arm and hand using the equipment. Relax as much as possible, keep the original shaking to make sure high performance of the equipment.

CONTRAINDICATIONS

Do not use the equipment if a pacemaker or electrical stimulation equipment is adopted. Users allergic to medical rubber are not commended to use this equipment.

EMC INFORMATION

Guidance and Manufacture’s Declaration – Electromagnetic Emission

TC200 is intended for use in the electromagnetic environment specified below. The customer or the user of TC200 should assure that they are used in such an environment.
Emission test| Compliance| Electromagnetic Environment – Guidance
RF emissions CISPR 11|

Group 1

| TC200 uses RF energy only for their internal function. Therefore, their RF emissions are very low and are not likely to cause any interference in nearby electronic device.
RF emission CISPR 11|

Class B

| TC200 is suitable for use in all establishments, other than domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.
Harmonic emissions IEC/EN 61000-3-2|

N/A

Voltage fluctuations/ flicker emissions IEC/EN 61000-3-3|

N/A

NOTE The EMISSIONS characteristics of TC200 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) TC200 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.

Guidance and Manufacture’s Declaration – Electromagnetic Immunity

TC200 is intended for use in the electromagnetic environment specified below. The customer or the user of TC200 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) IEC/EN 61000-4-2|

± 8 kV contact
± 15 kV air

|

± 8 kV contact
± 15 kV air

| When the relative humidity is approximately 5% and there are synthetic materials present, static charges approaching 15kV can be generated.
Electrical fast transient/burst IEC/EN 61000-4-4| ±2 kV for power supply lines| N/A| N/A
Surge IEC/EN 61000-4-5|

±1 kV for line to line
±2 kV for line to ground

| N/A| N/A
Power frequency (50/60Hz)

magnetic field IEC/EN 61000-4-8

| **** 30 A/m|

30 A/m

| This test level assumes a minimum distance between TC200 and sources of power frequency magnetic field of at least 15 cm.
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 % UT (60% dip in UT) for 5 cycles

70 % UT（30% dip in UT） for 25 cycles

<5 % UT (>95% dip in UT) for 5s

| N/A| N/A
NOTE UT is the a.c. mains voltage prior to application of the test level.

Guidance and Manufacture’s Declaration – Electromagnetic Immunity

TC200 is intended for use in the electromagnetic environment specified below. The customer or the user of TC200 should assure that they are used in such an environment.
Immunity test| IEC/EN 60601 Test Level| Compliance Level| Electromagnetic Environment – Guidance
Conducted RF IEC/EN 61000-4-6| 3 Vrms

150 kHz to 80 MHz

6 Vrms in ISM bands between 0,15 MHz and 80 MHz

| N/A| ****

Portable and mobile RF communications device should be used no closer to any part of TC200, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter.
Recommended separation distance
d = 1.2 P 150KHz to 80MHz

Radiated RF IEC/EN 61000-4-3| 3 V/m
80 MHz to 2.7 GHz| 3 V/m
80 MHz to 2.7 GHz Comply with table 1| ****

d = 1.2   P 80 MHz to 800 MHz

d = 2.3   P 800 MHz to 2.7 GHz

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 TC200, including cables specified by the manufacturer).

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,

• should be less than the compliance level in each frequency range.
• Interference may occur in the vicinity of device

| | | marked with the following symbol:
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.

• 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 TC200 is used exceeds the applicable RF compliance level above, TC200 should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating TC200.
• Over the frequency range 150 kHz to 80MHz, field strengths should be less than 3V/m.
• 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.

Recommended separation distances between portable and mobile RF communications device and TC200

TC200 is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of TC200 can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications device (transmitters) and TC200 as recommended below, according to the maximum output power of the communications device.

Rated maximum output power of transmitter
(W)

| 150 kHz to 80 MHz
d = 1.2  P| 80 MHz to 800 MHz
d = 1.2  P|

800 MHz to 2.5 GHz
d = 2.3   P

0.01| 0.12| 0.12| 0.23
0.1| 0.38| 0.38| 0.73
1| 1.2| 1.2| 2.3
10| 3.8| 3.8| 7.3
100| 12| 12| 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.

Test specifications for enclosure port immunity to RF wireless communications device

Test Frequency
(MHz)| Band a
(MHz)| Service a)| Modulation b)| Maximum Power (W)| Distance (m)| Test Frequency (MHz)
385| 380-390| TETRA 400| Pulse modulation b) 18 Hz| 1,8| 0,3| 27
450| 430-470| GMRS 460, FRS 460| FM c) ± 5 kHz deviation| 2| 0,3| 28
710|

704-787

|

LTE Band 13, 17

|

Pulse modulation b) 217 Hz

|

0,2

|

0,3

|

9

745
780
810|

800-960

| GSM 800/900,
TETRA 800,
iDEN 820,
CDMA 850,
LTE Band 5|

Pulse modulation b) 18 Hz

|

2

|

0,3

|

28

870
930
1720|

1700-1990

| GSM 1800; CDMA 1900; GSM 1900;
DECT;
LTE Band 1, 3, 4, 25;
UMTS|

Pulse modulation b) 217 Hz

|

2

|

0,3

|

28

1845
1970

2450

|

2400-2570

| Bluetooth, WLAN, 802.11 b/g/n, RFID 2450, LTE Band 7|

Pulse modulation b) 217 Hz

| 2| 0,3|

28

5240| 5100-5800|

WLAN 802.11 a/n

| Pulse modulation b) 217 Hz| 0,2| 0,3| 9
5500
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.

• For some services, only the uplink frequencies are included.
• The carrier shall be modulated using a 50 % duty cycle square wave signal.
• 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.

REGULATORY INFORMATION

FCC ID: 2ACGF-TC200
IC: 24095-TC200
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.

NOTE: This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to Part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference in a residential installation. This equipment generates, uses and can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to radio communications. However, there is no guarantee that interference will not occur in a particular installation. If this equipment does cause harmful interference to radio or television reception, which can be determined by turning the equipment off and on, the user is encouraged to try to correct the interference by one or more of the following measures:

• Reorient or relocate the receiving antenna.
• Increase the separation between the equipment and receiver.
• Connect the equipment into an outlet on a circuit different from that to which the receiver is connected.
• Consult the dealer or an experienced radio/TV technician for help.

NOTE: The manufacturer is not responsible for any radio or TV interference caused by unauthorized modifications to this equipment. such modifications could void the user’s authority to operate this equipment.
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 Industry Canada RSS standard(s). Operation is subject to the following two conditions:

1. This device may not cause interference, and
2. This device must accept any interference, including interference that may cause undesired operation of the device.

Specific Absorption Rate (SAR) Information

This Hand Tremor Data Collector meets the government’s requirements for exposure to radio waves. 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.

FCC RF Exposure Information and Statement

The SAR limit of USA (FCC) is 1.6 W/kg averaged over one gram of tissue. Device types: DTS (FCC ID: 2ACGF-TC200) has also been tested against this SAR limit. The highest SAR value reported under this standard during product certification for use at the body is 0.307 W/kg. This device was tested for typical body-worn operations with the back of the product kept 0 cm from the body. To maintain compliance with FCC RF exposure requirements, use accessories that maintain a 0 cm separation distance between the user’s body and the back of the handset. The use of belt clips, holsters and similar accessories should not contain metallic components in its assembly. The use of accessories that do not satisfy these requirements may not comply with FCC RF exposure requirements, and should be avoided.

LIMITED WARRANTY

The handle of the equipment is warranted to be free from defects within 12 months starting from date of purchase. The attachments (spoon and fork) and accessories (charging cable) are free from defects within 6 months starting from date of purchase.
Any part of the equipment, including attachments and accessories, is not allowed to be repaired by unspecified maintenance. One of the following occurs is not eligible for warranty claim:

• Damage caused by dismounting on customer’s own.
• Damage caused by unspecified maintenance by manufacturer.
• Damage caused by improper transportation.
• Damage caused by the failure to use in normal environment or according to the user manual.
• Manufacturing label being replaced or removed.

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 over recycling companies for possibility of re-use.
• Comply with relevant laws and regulations when disposing wasted parts and components.
• The equipment should be disposed as electronic waste.

COMPLIED STANDARDS

EN ISO 14971:2019(ISO 14971:2019 IDT)
EN ISO 15223-1:2016(ISO 15223-1:2016 IDT)
EN ISO 780:2015(ISO 780:2015 IDT)
EN 1041:2008+A1:2013
EN 60601-1:2006+A11:2011+A1:2013+A12:2014(IEC 60601-1:2005+A1:2012 IDT) EN 60601-1-11:2015(IEC 60601-1-11:2015 IDT)
EN 60601-1-2:2015(IEC 60601-1-2:2014 IDT)

MANUFACTURER INFORMATION

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

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