Withings SCT01 Withings Thermo User Manual

Withings Withings Thermo Users Manual

Users Manual

Changer smart temporal thermometer
INTRODUCTIONPackage contentWithings ThermoProtective capTwo AAA Alkaline (LR3) batteries (already inserted)Notice of useProduct descriptionWARNING AND PRECAUTIONSPlease read this section carefully before using Withings Thermo thermometer.Intended use – Important safety informationThe device is intended for use in measuring temperature in adult population, children and babiespopulation. This device is not suitable for children born before term.Withings Thermo (SCT01) is intended for the intermittent monitoring of human body temperature athome. Always consult your doctor. Self-diagnosis of measurement results and self-treatment aredangerous. Pregnant women should consult a doctor before using the thermometer. Please consultyour doctor when there is a temperature rise on:- Neonates and babies under 3 months- Patients over 60 year old- Immunocompromised patients- Bedridden patients- Transplanted patientsPlease consult your doctor if other symptoms (vomiting, diarrhea, pain, shivering, stiff neck….) occureven if there is no fever.This device is a precision thermometer measuring equipment liable to be understood by lay user butit still should be handled with care.
General safety- Do not use the device on premature babies (babies born before term)- Do not use this device for purpose other than the one described in this manual- Keep the device out the reach of children. Children must not play, swallow or eat the device.- This device is for personal use at home only.- The sensor lens is fragile: do not touch it with your fingers.- Do not expose the device to humidity or water. In case the unit is wet, wait until it is dry.- To clean the lens, use a soft dry cloth to wipe it or a cotton bud. For cleaning anddisinfection, please report to the cleaning section of this manual- Never try to disassemble or repair the product.- A long exposure of the device to lint, dust or sunlight might reduce its life time or damage it.Damaged sensor might lead to incorrect measurements.- Do not leave the thermometer unattended with infants or persons who cannot express theirconsent.- Do not use the thermometer for any purpose other than measuring temperature.- Do not disassemble the thermometer.- Do not use a cellular phone near the device. It may result in an operational failure.- Do not store the device at extreme temperatures (see operating range temperatures below)Precautions before use- Remove the protective cap prior to taking a measurement- The device and the patient should be in the same ambient temperature for 10 minutes.- Infants’ body temperature might vary more than adults’. Avoid making measurements onbabies after nursing or while they are crying. It is recommended to make measurementschildren when they are calm.- Do not take measurement over irritated skin or scars.- Please perform 3 measurements in a row in case of children under 3 months… If the 3measurements are different, always take the highest one.- If the patient has taken a bath or made exercise, please wait for 15 minutes beforeproceeding to a measurement.- If the thermometer was stored in a cool or a warm room, wait for 15 minutes beforeproceeding to a measurement.- Do not move the thermometer while taking the temperature measurement.- Please wait for one minute between two measurements.- Remove hair or sweat prior to taking a measurement.AAA alkaline cells usage– If AAA alkaline cells fluid should get on your skin or clothing, immediately rinse with plenty of cleanwater.– Use only two AAA alkaline cells with this blood pressure monitor. Do not use any other types ofAAA alkaline cells.– Do not insert AAA alkaline cells with their polarities incorrectly aligned. – Replace old AAA alkalinecells with new ones immediately. Replace all two AAA alkaline cells at the same time.– Do not use new and used AAA alkaline cells together.
AFTER USECleaning– Do not use an alcoholic-base or solvent agent to clean the device– Clean the device with a soft and dry cloth– Do not submerge the device or any of the components in water. Ensure that no liquid enters theinterior of the thermometer.– Do not dismantle the device or try to repair it by yourself. If any problem happens, refer to thedistributor– Do not operate the device under severe environment of extreme temperature or humidity, or directsunshine– Do not shake the unit violently– Do not let the device under strong shocks, such as dropping the unit on the floorWait for 10 minutes after cleaning before taking a temperature measurement.Storage– If you are not using the device for an extended period, remove the alkaline cells from the alumimumtube for storage.– Store the device and the components in a clean and safe location– Do not store the device in a wet, humid or dusty location. Do not store the device if it is directlyexposed to the sunlight.– Ensure that you place the protective cap on the sensor after each use to prevent damages to thesensor.MaintenanceIf you can’t fix the problems using the troubleshooting instructions, request service from ourdealer. Manufacturer will make available on requested circuit diagrams, component part lists,descriptions, calibration instructions, or other information that will assist manufacturer’s staffor authorized representative for repair. It is generally recommended to have the deviceinspected every 2 years, to ensure proper functioning and accuracy.TROUBLESHOOTINGIf you one of the following problems while you are using Withings Thermo, refer to this section tohelp solve the problem. If the problem persists, please contact our customer service. For any enquiry,the serial number must be provided. It can be found inside the battery cover. It is made of 12characters grouped by 2, each group separated by a column, for instance XX:YY:XX:YY:XX:YYProblemCauseSolutionBlank display. The device doesnot turn on.Multiple possible causes1. Check and correct the AAAalkaline cells polarities2. Remove the AAA alkalinecells and wait for one minute.Then install the AAA alkalinecells back.
3. Replace the AAA alkalinecells“Low batteryicon”Battery is lowReplace batteries.“Error”The temperature is outsideranges.Body mode : lower than 35°C(95°F) or higher than 43.2°C(109.76°F)Surface mode : lower than22°C (71.6°F) or higher than40°C (104°F)1.Make a newtemperaturemeasurement,referring to the usermanual.“Error”System errorContact customer serviceThe temperature seemsratherhighThe unit has been stored in acold roomLeave the unit in the roomwhere is the patient for 30minutes prior to the nextmeasurementThe temperature seems ratherlowThe skin has sweat on it orthere is hair on the skinEnsure that there is nohaire infront of the sensor. Clean theskin with a dry piece of clothand wait for 5 minutes prior totaking a measurementMeasurement wastakeninsurface modeSwitch in body mode (seemanual)The patient has been staying ina cold roomWait untilthe patient iswarmer before proceeding tomeasurementMeasurement was nottakenon the templePlease refer to the user manualto place the sensor on thecorrect locationBluetooth does not seem toworkSmartphone is out of rangePlease get your smartphonecloser to your device.Smartphone’s Bluetooth is OFFPlease switch your smartphoneBluetooth ONWi-Fi does not seem to workDevice is out of range from theWi-Fi sourcePlease get your smartphoneand device closer to yourdevice.Wi-Fi is OFFPlease switch your smartphoneWi-Fi ON as well as your routerWi-Fi on
Replacing the AAA alkaline cellsIf the low battery symbol appears in the Withings application, replace all two AAA alkaline cells atthe same time.1. Remove the AAA alkaline cells cover at the back of the thermometer.2. Install or replace two AAA alkaline cells so that the + (positive) and – (negative) polarities matchthe polarities indicated on the AAA alkaline cells compartment.3. Put the AAA alkaline cells cover back in place.If the device will not be used for a long period of time, it is advised to remove the alkaline cells.TECHNICAL DATAProduct DescriptionInfrared temporal thermometerBrandWithingsModelWithings ThermoModel numberSCT01SensorThermopileTemperature display3 digits (°C)and 4 digits (°F)Resolution0.1 °C / 0.1 °FMeasuring rangeBody mode : 35°C–43.2°C (95°F–109.8°F)Surface mode : 22°C – 40°C (71.6°F – 104°F)Accuracy(Body mode)± 0.2°C on 35.5°C–42.0°Crange(± 0.4°F on 95.9°F-107.6°F range)± 0.3°C (± 0.5°F) outside this rangeAccuracy (Surface mode)±0.3°C on22°C–40°Crange(± 0.5°F on 71.6°F – 104°F range)Operatingconditions of use ( Ambient temperature/ Humidity)10°C-40°C (50 °F-104 °F)15% ≤ RH ≤ 95% Storage conditions(Temperature / Humidity / AirPressure)-25°C (-13°F)-55°C (131°F)15% ≤ RH ≤ 95% 200 hPa ≤ RH ≤ 1060 hPa Power Supply2 x 1.5V (LR03 AAA Battery)Battery Life2 to 3 yearsAutomaticswitch-off30 secondsProtection against electric shockInternally Powered ME equipmentSizeL = 116 mm (4.57 in.) x Diam= 33.2 mm (1.31 in.)WeightApprox. 75g (battery included)–0.165 lbs.Package contentMain unit, 2 AAA (LR03) batteries (already installed),Protective lens cap, Quick start guide, InstructionmanualNotesSpecifications are subject to change without prior notice or any obligation on the parts of themanufacturer
Type BFStorage temperatureFCC ID : XNASCT01Keep it dry
FCC STATEMENTFederal Communications Commission (FCC) Statement 15.21You are cautioned that changes or modifications not expressly approved by the part responsible forcompliance could void the user’s authority to operate the equipment.15.105(b)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 protectionagainst harmful interference in a residential installation. This equipment generates, uses and canradiate radio frequency energy and, if not installed and used in accordance with the instructions, maycause harmful interference to radio communications. However, there is no guarantee thatinterference will not occur in a particular installation.If this equipment does cause harmful interference to radio or television reception, which can bedetermined by turning the equipment off and on, the user is encouraged to try to correct theinterference 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 isconnected.– Consult the dealer or an experienced radio/TV technician for help.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 and2) this device must accept any interference received, including interference that may causeundesired operation of the device.FCC RF Radiation Exposure Statement:This equipment complies with FCC radiation exposure limits set forth for an uncontrolledenvironment. End users must follow the specific operating instructions for satisfying RF exposurecompliance.This transmitter must not be co-located or operating in conjunction with any other antenna ortransmitter. This device complies withIndustry Canada license-exempt RSS standard(s). Operation is subject to the following twoconditions: (1) this device may not cause interference, and (2) this device must accept anyinterference, including interference that may cause undesired operation of the device.
RF STATEMENTMedical Electrical Equipment needs special precautions regarding EMC and needs to be installed andput into service according to the EMC information provided in the following.– Interference may occur in the vicinity of equipment marked with– Portable and mobile RF communication equipment (e.g. cell phones) can affect Medical ElectricalEquipment.– The use of accessories and cables other than those specified may result in increased emissions ordecreased immunity– The device uses RF energy only for its internal function. Therefore, its RF emissions are very lowand are not likely to cause any interference in nearby electronic equipment– The device is suitable for use in all establishments, including domestic establishments and thosedirectly connected to the public low voltage power supply network that supplies buildings used fordomestic purposes– Portable and mobile RF communications equipment should be used no closer to any part of thedevice, including cables, than the recommended separation distance calculated from the equationapplicable to the frequency of the transmitter– The device is intended for use in an electromagnetic environment in which radiated RFdisturbances are controlled. Any other accessories, transducers and cables may result in increasedemissions or decreased immunity and EMC performance.– The device should not be used adjacent to or stacked with other equipment and that if adjacent orstacked use is necessary, which should be observed to verify normal operation in the configuration inwhich it will be used.Medical Electrical Equipment needs special precautions regarding EMC and needs to be installed andput into service according to the EMC information provided in the following. Portable and mobile RFcommunication equipment (e.g. cell phones) can affect Medical Electrical Equipment. The use ofaccessories and cables other than those specified may result in increased emissions or decreasedimmunity of the unit.Guidance and manufacturer’s declaration-electromagnetic emissionsTheWithings Thermois intended for use in the electromagnetic environment specified below. The customeror the user of the Withings Thermo should assure that it is used in such an environment.Emissions testComplianceElectromagneticenvironment - guidanceCE emissionsCISPR11Group 1TheSCT01 Withings Thermouses RF energy only for itsinternal function. Therefore, its RF emissions are very low andare not likely to cause any interference in nearby electronicequipment.RE emissionsCISPR11Class BHarmonic emissionsIEC 61000-3-2Not applicableTheSCT01 Withings Thermois suitable for use in allestablishments, including domestic establishments and thosedirectly connected to the public low-voltage power supplynetwork that supplies buildings used for domestic purposes.Voltage fluctuations/Flicker emissionsIEC 61000-3-3Not applicable
EMC DATADeclaration – electromagnetic emissions and immunity for equipment and systems thatare not life-supporting and are specified for use only in a shielded locationNon-Life Support Equipment Separation Distance Calculation (3Vrms / 3V/m compliance)Rated maximum outputpower of transmitter (W)Separation distance according to frequency of transmitter (m)150 kHz to80 MHz inISM bandsd = [3,5] PV180 MHz to 800 MHzd = [3,5] P E1800 MHz to 2.5 GHzd = [ 7 ] P E10.010.120.120.230.10.370.370.7411.171.172.33103.693.697.3810011.6711.6723.33TheWithings Thermodeclaration electromagnetic immunityTheWithings Thermosystem is intended for use in the electromagnetic environment specified below.The customer or the user of the Withings Thermo system should assure that it is used in such anenvironment.Immunity testIEC 60601 testlevelCompliancelevelElectromagnetic environment–guidanceConductedRFIEC 61000-4-63 Vrms150 kHz to 80MHzN/AN/ARadiated RF IEC61000-4-33 V/m80 MHz to 2.5GHzN/APortable and mobile RF communicationsequipment should be used no closer to any partof the EQUIPMENT or SYSTEM including cables,than the recommended separation distancecalculated from the equation applicable to thefrequency of the transmitter. Interference mayoccur in the vicinity of equipment marked withthe following symbol.Declaration–electromagnetic immunityThe Withings Thermois intended for use in the electromagnetic environment specified below.The customer or the user of the Withings Thermo system should assure that it is used in such anenvironment.Immunity testIEC 60601testlevelCompliance levelElectromagnetic environment–guidanceElectrostaticdischarge6 kV contact 8 kVair6 kV contact 8 kVairFloors should be wood, concrete or ceramic tile.If floors are covered with synthetic material, therelative humidity should be at least 30 %.
(ESD)IEC 61000-4-2Electrical fasttransient/burstIEC 61000-4-42 kV for powersupply lines1 kV forinput/outputlinesN/AMains power quality should be that of a typicalcommercial or hospital environment.Surge IEC 61000-4-51kV differentialmode2 kV commonmodeN/AA Mains power quality should be that of atypical commercial or hospital environment.Voltage dips,shortinterruptions andvoltage variationson power supplyinput linesIEC 61000-4-11-5 % UT(95% dipin UT)for 0.5 cycle, -40% UT(60 % dip in UT)for 5 cycles, -70 %UT(30 % dip inUT) for 25 cycles,-5 % UT(95 % dip in UT)for 5 secN/AMains power quality should be that of a typicalcommercial or hospital environment. If the userof the EQUIPMENT or SYSTEM requirescontinued operation during power mainsinterruptions, it is recommended that theEQUIPMENT or SYSTEM be powered from anuninterruptible power supply or a battery.Power frequency(50/60 Hz)magnetic field IEC61000-4-83 A/mN/APower frequency magnetic fields should be atlevels characteristic of a typical location in atypical commercial or of hospital environment.DISPOSALActuation of European directives 2002/95/EC, 2002/96/EC and 2003/108/EC, for reduction in use ofdangerous substances in the electric and electronic device and for garbage disposal. The symbolapplied on the device or its packaging means that at the end of its useful life the product must not bedisposed of with domestic waste. At the end of devices useful life, the user must deliver it to the ablecollecting centers for electric and electronic garbage, or give back to the retailer when purchasing anew device. Disposing of the product separately prevents possible negative consequences for theenvironment and for health, deriving from inadequate disposal. It also allows the recovery of materialsof which it’s made up in order to obtain an important saving of energy and resources and to avoidnegative effects to the environment and health. In case of abusive disposal of device by the user, willbe applied administrative endorsements in compliance with current standard. The device and its partsis marred with regard to disposal, as appropriate, in accordance with national or regional regulations.
Reference to standardsThis device complies with the following normative documents : COUNCIL DIRECTIVE93/42/EEC of 14 June 1993 concerning medical devices as amended by Directive 2007/47/EC– EN ISO 80601-2-56 : Particular requirements for basic safety and essential performance ofclinical thermometers for body temperature measurement– EN ISO 12470-5: 2003 : “Clinical thermometers” – Part 5: Performance of infraredthermometers (with maximum device)– ASTM 1965E : ASTM Standard for Infrared Clinical Thermometer– EN ISO 13485: 2003/AC: 2009: Medical devices – Quality management systems –Requirements for regulatory purposes (ISO 13485:2003) Reference to standards contd.– EN ISO14971: 2012: Medical devices – Application of risk management to medical devices(ISO 14971: 2007, Corrected version 2007-10-01)– IEC60601-1: 2005 + CORR. 1 (2006) + CORR. 2 (2007); EN 60601-1: 2006 + AC (2010):Medical electrical equipment – Part 1: General requirements for basic safety and essentialPerformance– EN60601-1-2: 2007 CISPR: 2011: Medical electrical equipment: Part 1-2: General requirements for basic safety and essential performance-collateral standard electromagneticcompatibility– IEC/EN 60601-1-11: General requirements for basic safety and essential performance –Collateral Standard: Requirements for medical electrical equipment and medical electricalsystems used in the home healthcare environment– IEC 80601-2-30: 2009 (First Edition) for use in conjunction with IEC 60601-1:2005– EN300328 V1.8.1 Electromagnetic compatibility and Radio spectrum Matters (ERM);Wideband transmission systems; Data transmission equipment operating in the 2,4 GHz ISMband and using wide band modulation techniques; Harmonized EN covering the essentialrequirements of article 3.2 of the R&TTE Directive– EN301489-1-3 V1.9.2 (2011) Electromagnetic compatibility and Radio spectrum Matters(ERM); ElectroMagnetic Compatibility (EMC) standard for radio equipment and services; Part1: Common technical requirements– EN301489-1-17 V2.2.1(2012) Electromagnetic compatibility and Radio spectrum Matters(ERM); ElectroMagnetic Compatibility (EMC) standard for radio equipment and services; Part1: Common technical requirements– EN 55011: 2009/A1: 2010: Industrial, scientific and medical equipment –Radiofrequencydisturbance characteristics – Limits and methods of measurement– FCC part B 15B: 2013 Electromagnetic Compatibility– FCC Rule Part: 15.247 Cat: DSS (Bluetooth) FCC Rule Part: 15.247 Cat: DTS (BT4.0)– EN ISO 10993-1: 2009 Biological evaluation of medical devices – Part 1: Evaluation andtesting within a risk management process (ISO 10993-1:2009)– EN 980 : 2008 Symbols for use in labeling of medical devices

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