Rooti Labs M2-2016 Rooti RX User Manual InstructionManual revJ 20160307

Rooti Labs Limited Rooti RX InstructionManual revJ 20160307

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M2 2016 User Manual

User manual

ECG Event RecorderInstruction ManualRooti Labs Limited5F-1, No.71, Zhouzi St., Neihu Dist.,Taipei City 114, Taiwan (R.O.C.)Tel: +886 (2) 2656-0618E-mail: service@rootilabs.comhttps://www.rootilabs.com/Authorised Representative in the European communityUser Manual V1.00598 0560EC REPWellkang Ltd (www.CE-marking.eu)29 Harley St., London W1G 9QR, UK

1 TABLE OF CONTENTS BEFORE USE Introduction Product Description Safety Information Icon Explanation Operating the Rooti Rx Care and Maintenance Before Taking a Measurement OPERATION INSTRUCTIONSRooti Rx Components Rooti LinkInstruction Manual Features Applications Getting Started LED Indications Troubleshooting SpecificationFCC Statement 1 1 112234 4455666712121315 IntroductionThank you for purchasing the Rooti Rx. Product DescriptionThe Rooti Rx is a compact physiological monitoring module. The intended use of Rooti Rx is to provide a facility in the home, workplace and for recording and transmitting single lead EGG data to a qualified receiving station for interpretation by medical professionals. The Rooti Rx stores one lead electrocardiography(ECG) signals and recording data transmission via WiFi. To interpret recording data should be skilled at the level of a technician, doctor, nurse, or medical specialist. The Rooti Rx comes with the following components:•Rooti Rx •Charging Dock •Electrode Sticker x3•Instruction Manual Safety InformationTo assure the correct use of the product basic safety measures should always be followed including the warnings and cautions listed in this instruction manual.Please read this instruction manual thoroughly before using the unit.Please keep for future reference.BEFORE USEFill in for future referenceDATE PURCHASED:SERIAL NUMBER: • Staple your purchase receipt here

2 3Operating The Rooti Rx Read all of the information in the instruction manual and any other literature in the box before operating the unit. Subjects fitted with a heart pacemaker should not use the Rooti Rx. The Rooti Rx should not be used in conjunction with any defibrilla-tor, including implanted or AED devices. Please use standard USB power outlet. The USB power outlet must be certified to IEC/EN 60601-1 for 2 MOPP and examined regularly. When wearing the Rooti Rx to shower, RED LED flashes temporarily. Wipe dry the Rooti Rx after shower, RED LED stops flashing. If RED LED still flashes, please change new Electrode Pads. If LED continues flashing after all these steps or user has any other problem, please CONSULT DOCTOR. 0598-1060EC REPIP58SNLOTIcon ExplanationDo not reuseTemperature limitationRead this instruction manualthoroughly before using theunit.Type BF applied partAuthorised representative inthe European CommunityBattery must be recycledBatch CodeManufacturerDate of ManufactureCE Certificate0560RF CE CertificateUse ByIngress Protection5:Dust Protected8:Protected against the effects oftemporary immersion in waterDirect CurrentSerial NumberCaution:Indicates a potentially hazardous situation which, if not avoided, may result in minor or moderate injury to the user or patient or damage to the equipment or other property. If user feels itchy and allergic after the electrode sticker long-time attached to skin, please remove the sticker and ask users to CONSULT DOCTOR. We advise pregnant women and children to use this product under the supervision of a doctor. No modification of this equipment is allowed. Be aware of choking resulting from a child swallowing a small part that has become detached from Rooti Rx. Care And Maintenance Operate the Rooti Rx only as intended. Do not use the Rooti Rx for any other purpose. Do not submerge the Rooti Rx or any of the components in water. Do not wear Rooti Rx to swimming or taking a bath. Store the Rooti Rx and the components in a clean, safe location. (-10~60 C / 10~95% R.H. (noncondensing)) Ingress Protection5:Dust Protected8:Protected against the effects of temporary immersion in water The conductive parts of electrodes and associated connectors for type BF or CF applied parts, including neutral electrode, should not contact other conductive parts including earth. The disposal of Rooti Rx and accessories follows normal electronic waste recycling method. Side Effect If long time wearing Rooti Rx, users may feel itchy and a little bit allergic on skin. Contraindicationfollowing patient must be follow the doctor's instructions to use:1. Chronic Disease patients 2. Allergic to Polyester patient3. Pregnant woman 4. Children 5. Breastfeeding women

4 5Compatibility•iOS 8+•iPhone 5+•iPad Mini•iPad 3+Before Taking a MeasurementTo ensure a reliable measurement, follow these recommendations:- We suggest using alcohol pad to clean the back of Rooti Rx (Sensor Pad) before and after use. - During recording, please do not take off the Rooti Rx.- Electrode Sticker is only for ONE time use. Please change a new sticker every time before use. - When wearing the Rooti Rx to shower, RED LED flashes temporarily. Wipe dry the Rooti Rx after shower, RED LED stops flashing. If RED LED still flashes, please change new monitoring electrodes. If LED continues flashing after all these steps or user has any other problem, please CONSULT DOCTOR.- Please make sure to put the Rooti Rx onto the Charging Dock before data downloading. To have a better using experience, read the following items.- Quick RED LED flashing indicates LOW POWER while slow RED LED flashing indicates LEAD OFF.- When connecting to Rooti Rx, users cannot use the internet at the same time.- If user feels itchy and allergic after the electrode sticker long-time attached to skin, please remove the sticker and ask users to CONSULT DOCTOR.Rooti Rx has to be worked along with App “Rooti Link”. Download “Rooti Link” in Apple Store and follow the on-screen instruction to set up the Rooti Rx.Components:OPERATION INSTRUCTIONSFrontRooti RxFront BackCharging DockElectrode StickerRooti LinkBackSensorPadLEDFunctionButtonNotice: We suggest using ALCOHOL PAD to clean the back of Rooti Rx (Sensor Pad) before and after use. Double-sided tape(attach to Rooti Rx)SnapSnap (Snap with self-preparedMonitoring Electrodes)Double-sided tape(attach to user’s skin)USBCharger DockTransmit to Mobile Device Application

894. Offer Rooti Rx as a Tool for Your PatientsFollow the instructions in the app, set up Rooti Rx for your patients and start recording. (1) Step 1: Remove double-sided tape in the front side of Eletrode Sticker.(2) Step 2: Stick the Rooti Rx onto the FRONT of Electrode Sticker. Aim the circle steel dot to the hole of sticker.(3) Step 3: Snap in Monitoring Electrodes to Electrode Sticker.(4) Step 4: Remove adhesive tapes on the BACK of Electrode Sticker.(5) Step 5: Ask patients to stand still, chin up and chest out. Attach Rooti Rx on top of patients’ left chest. Make sure the sticker can cover on skin properly without abnormal stretching or twisting. (Approximately 3cm upper from left nipple.)*ATTENTION: a. Please use certificated self-prepared standard Monitoring Electrodes sold in general pharmacy.b. During the recording, teach patients to short press the button when they feel uncomfortable, and Rooti Rx will record ECG tags.12 3 45(3) Tap “Device Set Up” in main page. (4) Follow the instructions in the app and connect RootiLink with Rooti Rx.Notice: After connecting Wi-fi in Apple system, quickly press Home key twice to go back RootiLink.*aChest out whenattach Rooti RX

10 11c. If Rooti Rx leads off or not attaches well to your body, Red LED will keep lighting up. Please go back to hospital for medical support. 5. Preview modeAfter set up Rooti Rx, check the patients’ ECG signal/ skin tempera-ture through Preview mode of RootiLink. Make sure the ECG signal is stable and well-performed. 6. Set up recording days and countdown timer starts counting.At this time, Rooti Rx will work as a standalone recorder. 7. Review Record for Your PatientsAfter recording, help your patients to download their record in the app. Review history ECG data as your further diagnose references.(3) Follow the on-screen instruction in the app. Long press the Rooti Rx function button and activate Wi-Fi advertising (BLUE LED) to recon-nect Rooti Rx with RootiLink. (4) Tap “Download” and put the Rooti Rx into Charging Dock. Plug into power through USB charger. Short press to tag(1) Reopen RootiLink. (2) Remove electrode sticker from the Rooti Rx.(5) During the download, Rooti Rx flashes Blue LEDs quickly.(6) When download completed, you can review ECG Tag or ECG Date in History Data.

12 13LED IndicationsSpecificationTroubleshootingWhen short press the Rooti Rx, it indicates Red LED.Please charge the Rooti Rx by plugging into the Charging Dock.When connecting my phone with the Rooti Rx, why it stucks in the Wi-Fi searching list?iOS: Press “Home Key” twice to go back RootiLinkWhy is Rooti Rx keeps flashing RED? Rooti Rx is LOW BATTERY, please CONSULT DOCTOR/ MEDICAL PROFESSIONALS. Rooti Rx is in LEAD OFF status1. Please adjust Monitoring Electrodes and Electrode Sticker, see if they are finely attached.2. If 1. cannot solve the problem, change new Monitoring Electrodes.3. If 1. & 2. are not available to solve this problem, please CONSULT DOCTOR/ MEDICAL PROFESSIONALS.I am charging the Rooti Rx, it’s originally lightening GREEN, but it’s now no LED signal.Rooti Rx is now fully battery charged.0~40 C 20~93 %R.H. 80,0 kPa to 101,3 kPa(noncondensing)BrandModelItemMeasurement MethodRatingPower SourceBattery LifeOperating EnvironmentStorage and transportationEnvironmentRecord modeEnvironmentCharging modeand othersMain Unit WeightDimensions for Main UnitAccessoryRootiRooti RxRooti RxOne Lead Electrocardiogram, EKG/ECG Direct Current 3.7v 250 mAhLithium-ion PolymerBattery Pack 250 mAh AHB5216302 year or 500 timesExpected Service Life: 1 year14 g ± 1 g62 * 22.5 * 8.45 mmCharging dock, Electrode sticker0~50 C 20~93 %R.H. 80,0 kPa to 101,3 kPa(noncondensing)-10~60 C / 10~95 %R.H.(noncondensing)Rooti RxBattery LowLead OffRecord ECG tags N/APairing:Uploading:Battery Check: fullBattery Check: LowCharging:Finish Charging: N/A On BodyOff BodyOn BaseShort PressLong Press

14 15BrandModelItemOperating EnvironmentStorage and transportationEnvironmentMain Unit WeightDimensions for Main UnitRootiRooti RxCharging Dock 18 g 64 * 30 * 7 mm-10~60 C / 10~95 %R.H.(noncondensing)0~50 C / 20~93 %R.H. Atmospheric pressure 80,0 kPa to 101,3 kPa(noncondensing)Charging DockBrandModelItemOperating EnvironmentStorage and transportation EnvironmentMain Unit WeightDimensions for Main UnitRootiRooti RxElectrode Sticker0~50 C / 20~93 %R.H. Atmospheric pressure 80,0 kPa to 101,3 kPa(noncondensing)3.2 g 32.7 * 115 * 5.2 mmElectrode Sticker-10~60 C / 10~95 %R.H.(noncondensing)Federal Communications Commission (FCC) Statement(1) 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 cause undesired operation of the device.(2) You are cautioned that changes or modifications not expressly approved by the part responsi-ble for compliance could void the user’s authority to operate the equipment.(3) 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. FCC RF Exposure:“For body worn operation, this Rooti RX has been tested and meets FCC RF exposure guidelines when used with an accessory that contains no metal and that positions the Rooti RX a minimum of **5mm** from the body. Use of other accessories may not ensure compliance with FCC RF exposure guidelines.”To comply with the FCC RF exposure compliance requirements, this device and its antenna must not be co-located or operating in conjunction with any other antenna or transmitter. European Union Regulatory NoticeThis device bearing the CE marking is in compliance with the essential requirements and other relevant provisions of Directive : 1999/5/EC. This device complies with the following harmonized European standards. Radio: ETSI EN 300 328 V1.9.1 : 2015 / BS EN 62479 : 2010EMC: EN 301 489 –1 v1.9.2: 2011 / EN 301 489 –17 v2.2.1: 2012EN 55022: 2010+AC: 2011EN61000-3-2 : 2006+A1:2009+A2:2009 / EN61000-3-3 : 2008EN 61000-4-2 : 2009 / EN 61000-4-5 : 2006EN 61000-4-3 : 2006+A1:2008+A2:2010 / EN 61000-4-6 : 2014EN 61000-4-4 : 2012 / EN 61000-4-11 : 2004Safety : EN 60950-1: 2006+A11: 2009+A1: 2010+A12: 2011+A2: 2013©2016 Rooti Labs Limited. All rights reserved. Reproduction in whole or in part is prohibited. Rooti and Rx are trademarks of Rooti Labs Limited, applied in the U.S. and other countries.Service Life Expected Service Life: 1 year

16 17 The Rooti RX is intended for use in the electromagnetic environment specified below.The customer or the user of the Rooti RX should assure that it is used in such an environment.Emission test Compliance Electromagnetic environment-guidanceRF emissionsCISPR 11RF emissionsCISPR 11Harmonic emissionsIEC 61000-3-2Voltage fluctuations/flicker emissionsIEC 61000-3-3Group 1Class BClass AThe Rooti RX uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.The Rooti RX is suitable for use in all establishments, including domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.Compliance Guidance and manufacturer’s declaration -electromagnetic emissionsThe Rooti RX power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment.Mains power quality should be that of a typical commercial or hospital environment. If the user of the Rooti RXrequires continued operation during power mains interruptions, it is recommended that the Rooti RX be powered from an uninterruptible power supply or a battery. The Rooti RX is intended for use in the electromagnetic environment specified below.The customer or the user of the Rooti RX should assure that it is used in such an environment.Immunity test IEC 60601test levelCompliance level Electromagneticenvironment-guidanceElectrostaticdischarge(ESD)IEC 61000-4-2Electrical fasttransient/burstIEC 61000-4-4SurgeIEC 61000-4-5+ 6 kV contact+ 8 kV air+ 1kV line(s) to line(s)+ 2kV line(s) to earth+ 2kV for powersupply lines+ 1kV for input/output lines+ 22kV for powersupply linesNot applicable+ 1kV differentialmode Not applicable+ 6 kV contact+ 8 kV airFloors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%Mains power quality should be that of a typical commercial or hospital environment.Mains power quality should be that of a typical commercial or hospital environment.<5% UT(>95% dip in UT) for 0,5 cycle40% UT(60% dip in UT) for 5 cycles70% UT(30% dip in UT) for 25 cycles<5% UT(>95% dip in UT) for 5 s<5% UT(>95% dip in UT) for 0,5 cycle40% UT(60% dip in UT) for 5 cycles70% UT(30% dip in UT) for 25 cycles<5% UT(>95% dip in UT) for 5 sVoltage Dips, shortinterruptions and voltage variations on power supplyinput linesIEC 61000-4-11Power frequency (50, 60 Hz) magnetic fieldIEC 61000-4-83 A/m 3 A/mGuidance and manufacturer’s declaration-electromagnetic immunityNOTE UT is the a.c. mains voltage prior to application of the test level. The Rooti RX is intended for use in the electromagnetic environment specified below.The customer or the user of the Rooti RX should assure that it is used in such an environment.Immunity test IEC 60601 test level Compliance level Electromagnetic environment-guidanceConducted RFIEC 61000-4-6Radiated RFIEC 61000-4-3Portable and mobile RF communicationsequipment should be used no closer to any partof the Rooti RX including cables, than therecommended separation distance calculatedfrom the equation applicable to the frequency ofthe transmitter. Recommended separation distance:d = 1,2 √Pd = 1,2 √P 80MHz to 800 MHzd = 2,3 √P 800MHz to 2,5 GHzWhere 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 metres (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 ofequipment marked with the following symbol:3 Vrms150 KHz to 80 MHz3 V/m80MHz to 2,5 GHz3 Vrms3 V/mGuidance and manufacturer’s declaration-electromagnetic immunityNOTE1 At 80 MHz and 800 MHz, the higher frequency range applies.NOTE2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, 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 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 the Rooti RX is used exceeds the applicable RF compliance level above, the Rooti RX should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the Rooti RX.b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.ba Recommended separation distance betweenportable and mobile RF communications equipment and the Rooti RXThe Rooti RX is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the Rooti RX can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the Rooti RX as recommended below, according to the maximum output power of the communications equipment.Rated maximum output power of transmitterWSeparation distance according to frequency of transmitterm150 kHz to 80 MHzd =1,2√P80 MHz to 800 MHzd =1,2√P800 MHz to 2.5 GHzd =2,3√P0,01 0,12 0,12 0,230,1 0,38 0,38 0,731 1,2 1,2 2,310 3,8 3,8 7,3100 12 12 23For transmitters rated at a maximum output power not listed above, the recommended separation distance d in metres (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.NOTE1 At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.NOTE2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.

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