Rooti Labs M2-2016 Rooti RX User Manual InstructionManual revJ 20160307
Rooti Labs Limited Rooti RX InstructionManual revJ 20160307
User manual
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| Document ID | 2945377 |
| Application ID | k6Jcv4Ep8OEvLwNeeNnEUA== |
| Document Description | User manual |
| Short Term Confidential | No |
| Permanent Confidential | No |
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| Document Type | User Manual |
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| Filesize | 58.35kB (729336 bits) |
| Date Submitted | 2016-03-30 00:00:00 |
| Date Available | 2016-09-26 00:00:00 |
| Creation Date | 2016-03-14 11:26:32 |
| Producing Software | Adobe PDF library 10.01 |
| Document Lastmod | 2016-03-14 11:26:32 |
| Document Title | InstructionManual_revJ_20160307 |
| Document Creator | Adobe Illustrator CS6 (Windows) |
Rooti Labs Limited 5F-1, No.71, Zhouzi St., Neihu Dist., Taipei City 114, Taiwan (R.O.C.) Tel: +886 (2) 2656-0618 E-mail: service@rootilabs.com https://www.rootilabs.com/ EC REP Wellkang Ltd (www.CE-marking.eu) 29 Harley St., London W1G 9QR, UK 0598 Authorised Representative in the European community ECG Event Recorder 0560 Instruction Manual User Manual V1.0 BEFORE USE TABLE OF CONTENTS BEFORE USE Introduction Product Description Safety Information Icon Explanation Operating the Rooti Rx Care and Maintenance Before Taking a Measurement OPERATION INSTRUCTIONS Rooti Rx Components Rooti Link Instruction Manual Features Applications Getting Started LED Indications 12 Troubleshooting 12 Specification 13 FCC Statement 15 Introduction Thank you for purchasing the Rooti Rx. Fill in for future reference DATE PURCHASED: SERIAL NUMBER: • Staple your purchase receipt here Product Description The 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 Please read this instruction manual thoroughly before using the unit. Please keep for future reference. Safety Information To assure the correct use of the product basic safety measures should always be followed including the warnings and cautions listed in this instruction manual. Icon Explanation 60 Do not reuse Manufacturer Temperature limitation Date of Manufacture -10 Read this instruction manual thoroughly before using the unit. Type BF applied part EC REP LOT IP58 0598 CE Certificate 0560 RF CE Certificate Authorised representative in the European Community Use By Battery must be recycled Direct Current Batch Code Ingress Protection 5:Dust Protected 8:Protected against the effects of temporary immersion in water SN Serial Number Caution: 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. Operating 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 defibrillator, 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. 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 Protection 5:Dust Protected 8: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. Contraindication following patient must be follow the doctor's instructions to use: 1. Chronic Disease patients 2. Allergic to Polyester patient 3. Pregnant woman 4. Children 5. Breastfeeding women Before Taking a Measurement Components: To 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. Charging Dock OPERATION INSTRUCTIONS Rooti Rx Front Function Button Back Sensor Pad LED Notice: We suggest using ALCOHOL PAD to clean the back of Rooti Rx (Sensor Pad) before and after use. USB Charger Electrode Sticker Front Dock Back Double-sided tape (attach to Rooti Rx) Snap Double-sided tape (attach to user’s skin) Rooti Link Snap (Snap with self-prepared Monitoring Electrodes) 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. Compatibility •iOS 8+ •iPhone 5+ •iPad Mini •iPad 3+ Transmit to Mobile Device Application 1. Inside the box Rooti Rx x1 Electrode Sticker pack x3 Charging Dock x1 Instruction Manual x1 ECG Event Recorder Instruction Manual Features ECG (EC38 Type 3) Skin Temperature Uses Standard ECG Electrodes Wi-Fi data download Rechargeable USB charging Red/ Green/ Blue LED Function button IP58 Applications Hospital General Care Skilled Nursing Facilities Home based Remote Patient Monitoring Physiological status monitoring in real world situations an ua Getting Started Instruction Manual 2. Charge Rooti Rx Put the Rooti Rx into Charging Dock and plug it into power outlet, meanwhile, Green LED flashes. When full-charged the Rooti Rx, LED lights out. *ATTENTION: To achieve maximum product utility, please make sure to fully charge the Rooti Rx before use. 3. Download RootiLink App for your patient First, help your patient to set up RootiLink, the app for Rooti Rx. Ensure smart device is connected to Internet and search for “RootiLink” in App Store, download and set up a RootiLink account for your patient. (1) After downloaded, start RootiLink. (2) Sign up a new account for RootiLink, set up your personal profile. (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. 4. Offer Rooti Rx as a Tool for Your Patients Follow 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.) Chest out when attach Rooti RX *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. (1) Reopen RootiLink. Short press to tag c. 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 mode After set up Rooti Rx, check the patients’ ECG signal/ skin temperature through Preview mode of RootiLink. Make sure the ECG signal is stable and well-performed. (2) Remove electrode sticker from the Rooti Rx. (3) Follow the on-screen instruction in the app. Long press the Rooti Rx function button and activate Wi-Fi advertising (BLUE LED) to reconnect Rooti Rx with RootiLink. (4) Tap “Download” and put the Rooti Rx into Charging Dock. Plug into power through USB charger. (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. 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 Patients After recording, help your patients to download their record in the app. Review history ECG data as your further diagnose references. 10 11 Specification LED Indications Short Press Long Press Battery Low On Body Lead Off Record ECG tags Off Body N/A Pairing: Uploading: Battery Check: full On Base Battery Check: Low Charging: Finish Charging: N/A Troubleshooting When 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 RootiLink Why is Rooti Rx keeps flashing RED? Rooti Rx is LOW BATTERY, please CONSULT DOCTOR/ MEDICAL PROFESSIONALS. Rooti Rx is in LEAD OFF status 1. 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. 12 Rooti Rx Brand Rooti Model Rooti Rx Item Rooti Rx Measurement Method One Lead Electrocardiogram, EKG/ECG Rating Direct Current 3.7v 250 mAh Power Source Lithium-ion Polymer Battery Pack 250 mAh AHB521630 Battery Life 2 year or 500 times Expected Service Life: 1 year Operating Environment Record mode Environment 0~40 C 20~93 %R.H. 80,0 kPa to 101,3 kPa (noncondensing) Charging mode and others 0~50 C 20~93 %R.H. 80,0 kPa to 101,3 kPa (noncondensing) Storage and transportation -10~60 C / 10~95 %R.H.(noncondensing) Environment Main Unit Weight 14 g ± 1 g Dimensions for Main Unit 62 * 22.5 * 8.45 mm Accessory Charging dock, Electrode sticker 13 Charging Dock Brand Rooti Model Rooti Rx Item Charging Dock 0~50 C / 20~93 %R.H. Operating Environment Atmospheric pressure 80,0 kPa to 101,3 kPa (noncondensing) Service Life Expected Service Life: 1 year Storage and transportation -10~60 C / 10~95 %R.H.(noncondensing) Environment Main Unit Weight 18 g Dimensions for Main Unit 64 * 30 * 7 mm Electrode Sticker Brand Rooti Model Rooti Rx Item Electrode Sticker 0~50 C / 20~93 %R.H. Operating Environment Atmospheric pressure 80,0 kPa to 101,3 kPa (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 and 2) 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 responsible 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 Notice This 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 : 2010 EMC: EN 301 489 –1 v1.9.2: 2011 / EN 301 489 –17 v2.2.1: 2012 EN 55022: 2010+AC: 2011 EN61000-3-2 : 2006+A1:2009+A2:2009 / EN61000-3-3 : 2008 EN 61000-4-2 : 2009 / EN 61000-4-5 : 2006 EN 61000-4-3 : 2006+A1:2008+A2:2010 / EN 61000-4-6 : 2014 EN 61000-4-4 : 2012 / EN 61000-4-11 : 2004 Safety : EN 60950-1: 2006+A11: 2009+A1: 2010+A12: 2011+A2: 2013 Storage and transportation -10~60 C / 10~95 %R.H.(noncondensing) Environment Main Unit Weight 3.2 g Dimensions for Main Unit 32.7 * 115 * 5.2 mm 14 ©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. 15 Guidance and manufacturer’s declaration -electromagnetic emissions 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-guidance RF emissions CISPR 11 Group 1 The 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. RF emissions CISPR 11 Class B Harmonic emissions IEC 61000-3-2 Class A 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. Voltage fluctuations /flicker emissions IEC 61000-3-3 Compliance Guidance and manufacturer’s declaration-electromagnetic immunity 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 Conducted RF IEC 61000-4-6 3 Vrms 150 KHz to 80 MHz 3 Vrms Radiated RF IEC 61000-4-3 3 V/m 80MHz to 2,5 GHz 3 V/m Recommended separation distance: d = 1,2 √P d = 1,2 √P 80MHz to 800 MHz d = 2,3 √P 800MHz to 2,5 GHz 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 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 of equipment marked with the following symbol: Guidance and manufacturer’s declaration-electromagnetic immunity 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-guidance Electrostatic discharge(ESD) IEC 61000-4-2 + 6 kV contact + 8 kV air + 6 kV contact + 8 kV air Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30% Electrical fast transient/burst IEC 61000-4-4 + 2kV for power supply lines + 1kV for input/ output lines + 22kV for power supply lines Not applicable Mains power quality should be that of a typical commercial or hospital environment. Surge IEC 61000-4-5 + 1kV line(s) to line(s) + 2kV line(s) to earth + 1kV differential mode Not applicable Mains power quality should be that of a typical commercial or hospital environment. Voltage Dips, short interruptions and voltage variations on power supply input lines IEC 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 <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 Mains power quality should be that of a typical commercial or hospital environment. If the user of the Rooti RX requires continued operation during power mains interruptions, it is recommended that the Rooti RX be powered from an uninterruptible power supply or a battery. 3 A/m 3 A/m The Rooti RX power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment. Power frequency (50, 60 Hz) magnetic field IEC 61000-4-8 NOTE UT is the a.c. mains voltage prior to application of the test level. 16 Electromagnetic environment-guidance Portable and mobile RF communications equipment should be used no closer to any part of the Rooti RX including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. NOTE1 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. Recommended separation distance between portable and mobile RF communications equipment and the Rooti RX The 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 transmitter Separation distance according to frequency of transmitter 150 kHz to 80 MHz d =1,2√P 80 MHz to 800 MHz d =1,2√P 800 MHz to 2.5 GHz d =2,3√P 0,01 0,12 0,12 0,23 0,1 0,38 0,38 0,73 1,2 1,2 2,3 10 3,8 3,8 7,3 100 12 12 23 For transmitters rated at a maximum output power not listed above, the recommended separation distance d in 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. 17
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