GYENNO Technologies TC20 Hand tremor data collector User Manual

GYENNO Technologies CO., LTD. Hand tremor data collector

User Manual

-1-User ManualHand Tremor Data CollectorVersion NO.：TC20-EN-V2.1
-2-DEFINITIONSWARNING: Indicates a potentially hazardous situation which, if not avoided, could result indeath or serious injury.CAUTION: Indicates a potentially hazardous situation which, if not avoided, may result ininvalid data collecting ,damage to the equipment or invalid operation.NOTICE: Information necessary to be known before using the equipment.
-3-INTENDED USEThe hand tremor data collector is used to collect hand tremor data of user with Parkinson's Disease, Parkinson’sSyndrome, Essential Tremor, or other physical disabilities. It can also be used as an assistive equipment to eat.
-4-SAFETY INFORMATIONWARNING1Do not place or store the equipment near fire or heat articles.2Do not use a damaged charging cable or socket.3Do not use the equipment if a pacemaker or electrical stimulation equipment is adopted.4Users allergic to medical rubber are not commended to use this equipment.5Do not plug or unplug the charging cable when hands are wet.6Do not make self-diagnose based on data collected by the equipment.7Use of this equipment adjacent to or stacked with other equipment should be avoided because it couldresult in improper operation. If such use is necessary, this equipment and the other equipment should beobserved to verify that they are operating normally.8Use of accessories, transducers and cables other than those specified or provided by the manufacturer ofthis equipment could result in increased electromagnetic emissions or decreased electromagnetic immunityof this equipment and result in improper operation.CAUTION1Do not immerse the equipment except for attachments into any kind of liquid.2Do not use the equipment while charging.3In case the equipment falls into liquid while charging, unplug the cable immediately and wipe theequipment.4The attachments should not be disinfected with high temperature or microwaved.5The handle should not be washed in dishwasher, disinfected with high temperature or microwaved.6Do not use this equipment in a strong magnetic environment.7Do not exceed the maximum load of the equipment.8Do not dismount or attempt to repair the unit or components.NOTICE1Clean the attachments before using the equipment.
-5-KNOW YOUR UNITThe equipment can collect tremor data of user by built-in sensors and transfer the data via WiFi. A measurementresult will be obtained after further process. The equipment can also detect and offset shaking of hand to help usereat smoothly.ComponentsFigure 2 Components
-6-HandleFigure 3 Handle Side ViewItemDescription1Connecting point to attachments2Front part of handle3Distance sensor4Soft sleeve5Twist button6Rear part of handleTable 1 Handle Side View DescriptionFigure 4 Handle Rear View
-7-ItemDescription1Power buttonShort press: Turn on or off the equipmentLong press for 5 seconds: Enter WiFi configuration mode2Indicating light to identify different status3Fixing screw4Charging cable jack5Connecting dock for hand strapTable 2 Handle Rear View DescriptionAttachmentFigure 5 Spoon Attachment
-8-SYMBOLS USEDGeneral warning signGeneral caution signNotice signRefer to user manual.WEEE-Properly dispose of electronic wasteType BF applied partNon-ionizing radiationCE markUniversal recycling signIP24IP24 degree of protectionDirect currentIndicates the authorized representative in the European CommunityTable 7 Symbols Used by this Equipment
-9-SPECIFICATIONSDimensionsApprox. 233 (L) * 52.5 (W) * 31.5 (H) (mm)Total Weight≈ 155 gSpoon Weight≈ 6.7 gFork Weight≈ 5.4 gMeasurement RangeFrequency: 3 Hz to 12 HzAmplitude: 6 mm to 100 mmResolutionFrequency: 0.1 HzAmplitude: 1 mmAccuracyFrequency: 10% of readingAmplitude: ±1 mm or 10% of readingOperational ConditionsTemperature: 32 ℉to 113 ℉(0 ℃to +45 ℃)Humidity: 10% to 85% RHAir pressure: 700 hPa to 1060 hPaTransportation and StorageConditionsTemperature: -13 ℉to 158 ℉(-25 ℃to +70 ℃)Humidity: 10% to 93% RHAir pressure: 700 hPa to 1060 hPaPower Source5 V 1 AWorking Time3 days (3 meals per day or 30 records per day)Charging Time≤ 3hoursMaximum Load≈ 15 gWiFiProtocol802.11 b/g/nFrequency Range2400 MHz to 2483.5 MHzAntenna TypeBuilt-in antennaTable 8 Specifications
-10 -INDICATING LIGHT DESCRIPTIONColorStatusBreathing in greenStandbyGreenFully chargedBreathing in blueCollecting dataFlashing in blueWiFi connected or data transferringBreathing in redLow batteryRedChargingFlashing in yellowUnder WiFi configurationYellowWiFi not connectedNOTICE1If the indicating light alternates in red and yellow, the equipment is charging and not connected to WiFi.2If the indicating light alternates in green and yellow, the equipment is fully charged and not connected toWiFi.
-11 -DOWNLOAD MOBILE APPLICATIONPlease 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.
-12 -BEFORE USINGAttachments InstallationThe attachments will adhere to the handle by magnetic force when the attachments are placed near the handle asshown below.Figure 8 Install AttachmentHow to Hold the EquipmentMake sure the attachment is firmly connected to the handle before using. It is recommended to hold theequipment 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 StrapCAUTIONPlease always keep the twist button towards human body while using the equipment to ensure validity of datacollecting and assisting to eat.
-13 -Power On and OffShort press the power button to turn on or off the equipment. When the equipment is standby, the indicating lightbreaths in green.NOTICEThe equipment will automatically turn off if it had not been working for 5 minutes.
-14 -TAKING A MEASUREMENTWhen the equipment is on and once it detects tremor, data collecting will start. The indicating light breaths in blue.Figure 11 Taking a MeasurementThe data collecting process takes a few minutes (measurement period), when it is completed, the indicating lightbreaths in green. Each measurement period the equipment exports a measurement result including frequency andamplitude.NOTICE1Reboot the equipment before taking the next measurement.2Do not power off or put down the equipment before the measurement completes.Data TransferringAll data stored in the equipment will be transferred while charging. To transfer data, please connect the equipmentwith power supply by the charging cable.Figure 12 Connecting PowerThe equipment will automatically retry the saved latest wireless connection in a scanning window. If successfullyconnected, 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 lightflashes in blue and when the process is completed, the indicating light stays in yellow (charging) or green (charged).View the MeasurementThe measurement results, including the frequency (Hz) and amplitude (mm), can be viewed in “GYENNO SPOON”.NOTICEIf no measurement results are shown, it may be caused by:1None or incomplete data transfer due to WiFi connection problems.
-15 -2The measurement is terminated.
-16 -ASSIST TO EATShaking OffsetOnce the equipment detects tremor, the internal motors actively offset the shaking to keep stable.Figure 14 Vertical Shaking OffsetFigure 15 Horizontal Shaking OffsetTwist FunctionThe equipment offers a twist function to help the user eat noodles, spaghetti, pasta, etc. Install the fork beforeusing 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
-17 -AFTER USINGAttachments UninstallationPlease power off and uninstall the attachments after using. The handle should be placed horizontally. It issuggested that both the handle and attachments should be cleaned each time after using.ChargingIf the indicating light breaths in red, the equipment can still work for approximately 10 minutes. In order to protectthe 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 ChargingNOTICE1Adapter specification：5V 1A。2To avoid pollution, please properly dispose the equipment and charging cable according to local laws andrules related.
-18 -CLEANING AND DISINFECTIONAttachmentsNOTICEThe attachments should be cleaned before the first use.Please uninstall the attachments from the handle before cleaning. The attachments are suggested to wash withutensil detergent and water, they can also be cleaned in the dishwasher. Wipe the attachments with dry cloth. Donot 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 withozone, ultraviolet rays, high temperature disinfection is not permitted.Soft SleeveTo clean the soft sleeve, use a cotton swab with warm water and mild detergent, and dry it with a clean cottonswab. 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 CoverThe handle should never be submerged in water or cleaned in the dishwasher. Wipe the handle or cover clean withantibacterial 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 thedishwasher. After cleaning, dry it with a clean, soft cloth. Do not use corrosive solutions to wipe or clean.Hand StrapPlease put off the hand strap from the handle and wash it with a mild detergent, then rinse it off.
-19 -MAINTENANCE1. The attachment should be uninstalled from the handle before cleaning. Use a small portion of utensil detergentand 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 andclean 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 thisequipment 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 otherpurposes.10. The service life of this equipment is 3 years (3 meals per day or 30 records per day).
-20 -TROUBLESHOOTINGProblemsCauses and solutionsNo data shownThe equipment is not registered in “GYENNO SPOON” .Please register the equipment follow the instructions in “GYENNO SPOON” .The equipment is not connected to the WiFi.Please configure the WiFi follow the instructions in “GYENNO SPOON”.Insufficient time for measurementPlease refer to the section "Taking a measurement"The rubber sleeve breaksPlease stop using the equipment and contact GYENNO Service.Unable to chargeUnable to offset shakingUnable to twistOthers
-21 -PRECAUTIONS1. It is suggested to use this equipment independently at the first time to avoid worse tremor caused by theanxiety 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 ofadopting 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 usedto 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 theoriginal shaking to make sure high performance of the equipment.
-22 -CONTRAINDICATIONSDo 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.
-23 -EMC INFORMATIONGuidance and manufacture’s declaration – electromagnetic emissionTC20 is intended for use in the electromagnetic environment specified below. The customer or the user of TC20 should assure that theyare used in such an environment.Emission testComplianceElectromagnetic environment – guidanceRF emissionsCISPR 11Group 1TC20 uses RF energy only for their internal function. Therefore, their RF emissionsare very low and are not likely to cause any interference in nearby electronic device.RF emissionCISPR 11Class BTC20 is suitable for use in all establishments, other than domestic establishmentsand those directly connected to the public low-voltage power supply network thatsupplies buildings used for domestic purposes.Harmonic emissionsIEC/EN 61000-3-2N/AVoltage fluctuations/flicker emissionsIEC/EN 61000-3-3N/ANOTE 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 offeradequate protection to radio-frequency communication services. The user might need to take mitigation measures,such as relocating or re-orienting the device.
-24 -Guidance and manufacture’s declaration – electromagnetic immunityTC20 is intended for use in the electromagnetic environment specified below. The customer or the user of TC20 should assure that theyare used in such an environment.Immunity testIEC/EN 60601 test levelCompliance levelElectromagnetic environment - guidanceElectrostatic discharge (ESD)IEC/EN 61000-4-2± 8 kV contact± 15 kV air± 8 kV contact± 15 kV airFloors should be wood, concrete or ceramictile. If floor are covered with syntheticmaterial, the relative humidity should be atleast 30%.Electrical fast transient/burstIEC/EN 61000-4-4±2 kV for power supplylinesN/AN/ASurgeIEC/EN 61000-4-5±1 kV for line to line±2 kV for line to groundN/AN/APower frequency(50/60Hz)magnetic fieldIEC/EN 61000-4-830 A/m30 A/mPower frequency magnetic fields should beat levels characteristic of a typical location ina typical commercial or hospitalenvironment.Voltage dips, shortinterruptions and voltagevariations on power supplyinput linesIEC/EN 61000-4-11<5 % UT（>95% dip inUT）for 0.5 cycle40 % UT（60% dip in UT）for 5 cycles70 % UT（30% dip in UT）for 25 cycles<5 % UT（>95% dip inUT）for 5 sN/AN/ANOTE UTis the a.c. mains voltage prior to application of the test level.
-25 -Guidance and manufacture’s declaration – electromagnetic immunityTC20 is intended for use in the electromagnetic environment specified below. The customer or the user of TC20 should assure that theyare used in such an environment.Immunity testIEC/EN 60601 test levelCompliance levelElectromagnetic environment - guidanceConducted RFIEC/EN 61000-4-63 Vrms150 kHz to 80 MHz6 Vrms in ISM bands between0,15 MHz and 80 MHzN/APortable and mobile RF communications deviceshould be used no closer to any part of TC20,including cables, than the recommendedseparation distance calculated from theequation applicable to the frequency of thetransmitter.Recommended separation distance u lim  150KHz to 80MHzRadiated RFIEC/EN 61000-4-33 V/m80 MHz to 2.7 GHzSee table 13 V/m80 MHz to 2.7 GHzComply with table 1 u lim  80 MHz to 800 MHz u mi  800 MHz to 2.7 GHzd=6 /E at RF wireless communicationsdevice bands (Portable RF communicationsdevice (including peripherals such as antennacables and external antennas) should be usedno closer than 30 cm (12 inches) to any part ofthe TC20, including cables specified by themanufacturer).Where P is the maximum output power rating ofthe transmitter in watts (W) according to thetransmitter manufacturer and d is therecommended separation distance in meters(m).Field strengths from fixed RF transmitters, asdetermined by an electromagnetic site survey,ashould be less than the compliance level in eachfrequency range.bInterference may occur in the vicinity of devicemarked 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 fromstructures, objects and people.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 theelectromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measuredfield strength in the location in which TC20 is used exceeds the applicable RF compliance level above, TC20 should be observed toverify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting orrelocating TC20.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 to13,567 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 MHzare 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 14,2MHz, 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 54,0MHz.
-26 -Test specifications for enclosure port immunity to RF wireless communications deviceTestfrequency(MHz)Band a)(MHz)Service a)Modulation b)Maximumpower(W)Distance(m)Testfrequency(MHz)385380-390TETRA 400Pulse modulation b) 18 Hz1,80,327450430-470GMRS 460, FRS 460FM c) ± 5 kHz deviation20,328710704-787LTE Band 13, 17Pulse modulation b) 217 Hz0,20,39745780810800-960GSM 800/900, TETRA 800,iDEN 820, CDMA 850, LTEBand 5Pulse modulation b) 18 Hz20,32887093017201700-1990GSM 1800; CDMA 1900; GSM1900; DECT; LTE Band 1, 3, 4,25; UMTSPulse modulation b) 217 Hz20,3281845197024502400-2570Bluetooth, WLAN, 802.11 b/g/n,RFID 2450, LTE Band 7Pulse modulation b) 217 Hz20,32852405100-5800WLAN 802.11 a/nPulse modulation b) 217 Hz0,20,3955005785NOTE 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 fromstructures, 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 actualmodulation, it would be worst case.
-27 -Recommended separation distances between portable and mobile RF communications device and TC20TC20 is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the userof TC20 can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RFcommunications device (transmitters) and TC20 as recommended below, according to the maximum output power of thecommunications device.Rated maximum output powerof transmitter(W)150 kHz to 80 MHz u lim 80 MHz to 800 MHz u lim 800 MHz to 2.5 GHz u mi 0.010.120.120.230.10.380.380.7311.21.22.3103.83.87.3100121223For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can beestimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of thetransmitter 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 fromstructures, objects and people.
-28 -REGULATORY INFORMATIONFCC ID: 2ACGF-TC20IC: 24095-TC20This 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 againstharmful interference in a residential installation. This equipment generates, uses and can radiate radiofrequency energy and, if not installed and used in accordance with the instructions, may cause harmfulinterference to radio communications. However, there is no guarantee that interference will not occur in aparticular installation. If this equipment does cause harmful interference to radio or television reception, whichcan be determined by turning the equipment off and on, the user is encouraged to try to correct theinterference by one or more of the followingmeasures:-- 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 isconnected.-- 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 unauthorizedmodifications to this equipment. such modifications could void the user’s authority to operate this equipmentChanges or modifications not expressly approved by the party responsible for compliance could void the user'sauthority to operate the equipment.This device complies with Industry Canada RSS standard(s). Operation is subject to the following twoconditions: (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 delicence. 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 brouillageest 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 hasestablished detailed SAR requirements and has established that these requirements. This model meets theapplicable government requirements for exposure to radio frequency waves. The highest reported SAR levelfor usage near the body (0mm) is 0.36 W/kg
-29 -LIMITED WARRANTYThe 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 startingfrom date of purchase.Any part of the equipment, including attachments and accessories, is not allowed to be repaired by unspecifiedmaintenance. 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.
-30 -DISPOSALGYENNO has always been committed to earth care, we also encourage our users to make contribution by executingproper 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.
-31 -COPYRIGHT AND RESPONSIBILITYThe copyrights and confidentiality of this manual are owned by GYENNO.This manual is subjected to be a reference for operating and maintaining the equipment.
-32 -COMPLIED STANDARDSEN 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+A1:2013EN 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)
-33 -MANUFACTURER INFORMATIONManufacturerGYENNO Technologies CO., LTD.AddressA805, IER of HUST, No.9 Yuexing Ave 3, Nanshan District, Shenzhen, 518057, China.Tel.0086-755-86724035Emailservice@gyenno.comWebsitewww.gyenno.com

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