GYENNO Technologies TC20 Hand tremor data collector User Manual
GYENNO Technologies CO., LTD. Hand tremor data collector
User Manual
User Manual Hand Tremor Data Collector Version NO.: TC20-EN-V2.1 -1- 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. -2- 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 an assistive equipment to eat. -3- 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. Use of this equipment adjacent to or stacked with other equipment should be avoided because it could 7 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. Use of accessories, transducers and cables other than those specified or provided by the manufacturer of 8 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. 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 1 Clean the attachments before using the equipment. -4- KNOW YOUR UNIT The equipment can collect tremor data of user by built-in sensors and transfer the data via WiFi. A measurement result will be obtained after further process. The equipment can also detect and offset shaking of hand to help user eat smoothly. Components Figure 2 Components -5- Handle Figure 3 Handle Side View Item Description Connecting point to attachments Front part of handle Distance sensor Soft sleeve Twist button Rear part of handle Table 1 Handle Side View Description Figure 4 Handle Rear View -6- Item Description Power button Short press: Turn on or off the equipment Long press for 5 seconds: Enter WiFi configuration mode Indicating light to identify different status Fixing screw Charging cable jack Connecting dock for hand strap Table 2 Handle Rear View Description Attachment Figure 5 Spoon Attachment -7- SYMBOLS USED General warning sign General caution sign Notice sign Refer to user manual. WEEE-Properly dispose of electronic waste Type BF applied part Non-ionizing radiation CE mark Universal recycling sign IP24 IP24 degree of protection Direct current Indicates the authorized representative in the European Community Table 7 Symbols Used by this Equipment -8- SPECIFICATIONS Approx. 233 (L) * 52.5 (W) * 31.5 (H) (mm) Dimensions 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: 32 ℉ to 113 ℉ (0 ℃ to +45 ℃) Humidity: 10% to 85% RH Air pressure: 700 hPa to 1060 hPa Transportation and Storage Conditions Temperature: -13 ℉ to 158 ℉ (-25 ℃ to +70 ℃) Humidity: 10% to 93% RH Air pressure: 700 hPa to 1060 hPa Power Source WiFi 5V 1A Working Time 3 days (3 meals per day or 30 records per day) Charging Time ≤ 3hours Maximum Load ≈ 15 g Protocol 802.11 b/g/n Frequency Range 2400 MHz to 2483.5 MHz Antenna Type Built-in antenna Table 8 Specifications -9- INDICATING LIGHT DESCRIPTION Color Status Breathing in green Standby Green Fully charged Breathing in blue Collecting data Flashing in blue WiFi connected or data transferring Breathing in red Low battery Red Charging Flashing in yellow Under WiFi configuration Yellow WiFi not connected NOTICE If the indicating light alternates in red and yellow, the equipment is charging and not connected to WiFi. If the indicating light alternates in green and yellow, the equipment is fully charged and not connected to WiFi. - 10 - 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 WiFi configuration instructions. - 11 - 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. Figure 8 Install Attachment 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. Figure 9 Holding with the Hand Strap CAUTION Please always keep the twist button towards human body while using the equipment to ensure validity of data collecting and assisting to eat. - 12 - 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. - 13 - TAKING A MEASUREMENT When the equipment is on and once it detects tremor, data collecting will start. The indicating light breaths in blue. Figure 11 Taking a Measurement 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 Reboot the equipment before taking the next measurement. 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. Figure 12 Connecting Power 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 WiFi 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 yellow (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: None or incomplete data transfer due to WiFi connection problems. - 14 - 2 The measurement is terminated. - 15 - ASSIST TO EAT Shaking Offset Once the equipment detects tremor, the internal motors actively offset the shaking to keep stable. Figure 14 Vertical Shaking Offset Figure 15 Horizontal Shaking Offset 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. Figure 16 Twist Function - 16 - 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. Figure 17 Charging NOTICE Adapter specification:5V To avoid pollution, please properly dispose the equipment and charging cable according to local laws and rules related. 1A。 - 17 - 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. - 18 - 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 30 records per day). - 19 - TROUBLESHOOTING Problems Causes and solutions The equipment is not registered in “GYENNO SPOON” . Please register the equipment follow the instructions in “GYENNO SPOON” . No data shown The equipment is not connected to the WiFi. Please configure the WiFi follow the instructions in “GYENNO SPOON”. Insufficient time for measurement Please refer to the section "Taking a measurement" The rubber sleeve breaks Unable to charge Unable to offset shaking Please stop using the equipment and contact GYENNO Service. Unable to twist Others - 20 - PRECAUTIONS 1. 2. 3. 4. 5. 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. 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. A big and shallow bowl helps when using the equipment as an assistive tool to eat. 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. 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. - 21 - 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. - 22 - EMC INFORMATION Guidance and manufacture’s declaration – electromagnetic emission TC20 is intended for use in the electromagnetic environment specified below. The customer or the user of TC20 should assure that they are used in such an environment. Emission test Compliance RF emissions CISPR 11 Group 1 RF emission CISPR 11 Class B Harmonic emissions IEC/EN 61000-3-2 N/A Voltage fluctuations/ flicker emissions IEC/EN 61000-3-3 N/A Electromagnetic environment – guidance TC20 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. TC20 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. NOTE The EMISSIONS characteristics of TC20 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) TC20 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. - 23 - Guidance and manufacture’s declaration – electromagnetic immunity TC20 is intended for use in the electromagnetic environment specified below. The customer or the user of TC20 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 Floors should be wood, concrete or ceramic tile. If floor are covered with synthetic material, the relative humidity should be at least 30%. 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 Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment. 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 5 s N/A N/A NOTE UT is the a.c. mains voltage prior to application of the test level. - 24 - Guidance and manufacture’s declaration – electromagnetic immunity TC20 is intended for use in the electromagnetic environment specified below. The customer or the user of TC20 should assure that they are used in such an environment. Immunity test Conducted RF IEC/EN 61000-4-6 Radiated RF IEC/EN 61000-4-3 IEC/EN 60601 test level Compliance level 3 Vrms 150 kHz to 80 MHz 6 Vrms in ISM bands between 0,15 MHz and 80 MHz N/A 3 V/m 80 MHz to 2.7 GHz 3 V/m 80 MHz to 2.7 GHz See table 1 Comply with table 1 Electromagnetic environment - guidance Portable and mobile RF communications device should be used no closer to any part of TC20, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Recommended separation distance u lim 150KHz to 80MHz u lim 80 MHz to 800 MHz u mi 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 TC20, 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,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: NOTE 1 NOTE 2 a. b. c. At 80 MHz and 800 MHz, the higher frequency range applies. 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 TC20 is used exceeds the applicable RF compliance level above, TC20 should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating TC20. 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. - 25 - 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 0,3 28 704-787 LTE Band 13, 17 Pulse modulation b) 217 Hz 0,2 0,3 800-960 GSM 800/900, TETRA 800, iDEN 820, CDMA 850, LTE Band 5 Pulse modulation b) 18 Hz 0,3 28 1700-1990 GSM 1800; CDMA 1900; GSM 1900; DECT; LTE Band 1, 3, 4, 25; UMTS Pulse modulation b) 217 Hz 0,3 28 2400-2570 Bluetooth, WLAN, 802.11 b/g/n, RFID 2450, LTE Band 7 Pulse modulation b) 217 Hz 0,3 28 5100-5800 WLAN 802.11 a/n Pulse modulation b) 217 Hz 0,2 0,3 710 745 780 810 870 930 1720 1845 1970 2450 5240 5500 5785 NOTE 1 NOTE 2 At 80 MHz and 800 MHz, the higher frequency range applies. 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. 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. a) b) - 26 - Recommended separation distances between portable and mobile RF communications device and TC20 TC20 is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of TC20 can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications device (transmitters) and TC20 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 u lim 80 MHz to 800 MHz u lim 800 MHz to 2.5 GHz u mi 0.1 0.38 0.38 0.73 1.2 1.2 2.3 10 3.8 3.8 7.3 100 12 12 23 0.01 0.12 0.12 0.23 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. - 27 - REGULATORY INFORMATION FCC ID: 2ACGF-TC20 IC: 24095-TC20 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. Le présent appareil est conforme aux CNR d'Industrie Canada applicables aux appareils radio exempts de licence. L'exploitation est autorisée aux deux conditions suivantes: (1) il ne doit pas produire de brouillage et (2) l’ utilisateur du dispositif doit étre prêt à accepter tout brouillage radioélectrique reçu, même si ce brouillage est susceptible de compromettre le fomctionnement du dispositif. RF Radiation Exposure and SAR Statements SAR Statement. The TC20 has been tested for body-worn Specific Absorption Rate (SAR) compliance. The FCC/IC has established detailed SAR requirements and has established that these requirements. This model meets the applicable government requirements for exposure to radio frequency waves. The highest reported SAR level for usage near the body (0mm) is 0.36 W/kg - 28 - 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. - 29 - 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. - 30 - 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. - 31 - COMPLIED STANDARDS EN ISO 14971:2012(ISO 14971:2007 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) - 32 - MANUFACTURER INFORMATION Manufacturer Address GYENNO Technologies CO., LTD. A805, IER of HUST, No.9 Yuexing Ave 3, Nanshan District, Shenzhen, 518057, China. Tel. 0086-755-86724035 Email service@gyenno.com Website www.gyenno.com - 33 -
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