Mindray BIO Medical electronics WM3000 Mobile Remote ECG Measurement System User Manual

Shenzhen Mindray BIO-Medical electronics Co.,LTD. Mobile Remote ECG Measurement System

User Manual

I Wearable ECG Monitor Operator’s Manual
II © Copyright 2014-2016 Shenzhen Mindray Bio-Medical Electronics Co., Ltd. All rights reserved. For this Operator’s Manual, the issue date is 2016-4.
III Intellectual Property Statement SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD. (hereinafter called Mindray) owns the intellectual property rights to this Mindray product and this manual. This manual may refer to information protected by copyrights or patents and does not convey any license under the patent rights of Mindray, nor the rights of others. Mindray intends to maintain the contents of this manual as confidential information. Disclosure of the information in this manual in any manner whatsoever without the written permission of Mindray is strictly forbidden. Release, amendment, reproduction, distribution, rental, adaption and translation of this manual in any manner whatsoever without the written permission of Mindray is strictly forbidden. , , and are the registered trademarks or trademarks owned by Mindray in China and other countries. All other trademarks that appear in this manual are used only for editorial purposes without the intention of improperly using them. They are the property of their respective owners. Responsibility on the Manufacturer Party Contents of this manual are subject to changes without prior notice. All information contained in this manual is believed to be correct. Mindray shall not be liable for errors contained herein nor for incidental or consequential damages in connection with the furnishing, performance, or use of this manual. Mindray is responsible for the effects on safety, reliability and performance of this product, only if:  all installation operations, expansions, changes, modifications and repairs of this product are conducted by Mindray authorized personnel;  the electrical installation of the relevant room complies with the applicable national and local requirements;  the product is used in accordance with the instructions for use.
IV Warranty THIS WARRANTY IS EXCLUSIVE AND IS IN LIEU OF ALL OTHER WARRANTIES, EXPRESSED OR IMPLIED, INCLUDING WARRANTIES OF MERCHANTABILITY OR FITNESS FOR ANY PARTICULAR PURPOSE. Exemptions Mindray's obligation or liability under this warranty does not include any transportation or other charges or liability for direct, indirect or consequential damages or delay resulting from the improper use or application of the product or the use of parts or accessories not approved by Mindray or repairs by people other than Mindray authorized personnel. This warranty shall not extend to Malfunction or damage caused by improper use or man-made failure. Malfunction or damage caused by unstable or out-of-range power input. Malfunction or damage caused by force majeure such as fire and earthquake. Malfunction or damage caused by improper operation or repair by unqualified or unauthorized service people. Malfunction of the instrument or part whose serial number is not legible enough. Others not caused by instrument or part itself. Company Contact Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd. Address: Mindray Building, Keji 12th Road South, Hi-tech industrial park, Nanshan,Shenzhen 518057,P.R.China Website: www.mindray.com E-mail Address: service@mindray.com Tel: +86 755 81888998 Fax: +86 755 26582680 EC-Representative: Shanghai International Holding Corp. GmbH(Europe) Address: Eiffestraβe 80, 20537 Hamburg, Germany Tel: 0049-40-2513175 Fax: 0049-40-255726
V Preface Manual Purpose This manual contains the instructions necessary to operate the product safely and in accordance with its function and intended use. Observance of this manual is a prerequisite for proper product performance and correct operation and ensures patient and operator safety. This manual is based on the maximum configuration and therefore some contents may not apply to your product. If you have any question, please contact us. This manual is an integral part of the product. It should always be kept close to the equipment so that it can be obtained conveniently when needed. Intended Audience This manual is geared for clinical professionals and common people. Illustrations All illustrations in this manual serve as examples only. They may not necessarily reflect the setup or data displayed on your product. Conventions Italic text is used in this manual to quote the referenced chapters or sections.
1 Contents 1.1.1 Warnings...............................................................................................................21.1.2 Cautions................................................................................................................31.1.3 Notes.....................................................................................................................31.2 Equipment Symbols.........................................................................................................42.1 Product introduction.........................................................................................................12.1.1 Apply scope..........................................................................................................11.2.1AppliedParts..........................................................................................................12.2 Product appearance.........................................................................................................23.1 Installation.........................................................................................................................13.1.1 Unpacking and Checking...................................................................................11.2.2 Environmental Requirements............................................................................23.1.2 Power requirements............................................................................................23.1.3 Installation method..............................................................................................23.2 Cleaning and Disinfection...............................................................................................23.2.1 Cleaning................................................................................................................23.2.2 Disinfection...........................................................................................................34.1 Preparation before use....................................................................................................14.2 Wear the ECG recorder...................................................................................................14.3 View ECG data.................................................................................................................34.4 Take off the ECG recorder..............................................................................................34.5 Charge the ECG recorder...............................................................................................44.6 Offline data transimission................................................................................................55.1 Frequence Questions Management..............................................................................67.1 ECG Sensor......................................................................................................................27.2 Charger..............................................................................................................................3A Product Specifications.................................................................................................A‐1A.1 Safety Specifications...................................................................................................A‐1A.2 Environmental Specifications.....................................................................................A‐1A.3 Power Supply Specifications......................................................................................A‐1A.4 Physical Specifications...............................................................................................A‐2A.5 Display, Recorder and Storage Specification..........................................................A‐2A.6 ECG Specification.......................................................................................................A‐2A.7 Charger Specification..................................................................................................A‐2B EMC and Radio Regulatory Compliance....................................................................B‐1B.1 EMC...............................................................................................................................B‐1B.2 Radio Regulatory Compliance...................................................................................B‐6C Symbols and Abbreviations.........................................................................................C‐1C.1 Symbols.........................................................................................................................C‐1C.2 Abbreviations................................................................................................................C‐2
1 1.Safety 1.1 Safety Information WARNING Indicates a potential hazard or unsafe practice that, if not avoided, could result in death or serious injury. CAUTION Indicates a potential hazard or unsafe practice that, if not avoided, could result in minor personal injury or product/property damage. NOTE Provides application tips or other useful information to ensure that you get the most from your product.
2 1.1.1 Warnings WARNING  This equipment can not be used for infant whose weight is less than 10 Kg.  Before putting the system into operation, the operator must verify that the equipment, connecting cables and accessories are in correct working order and operating condition.  This equipment can not be used for the person whose skin is hypersusceptible to the the accessories.  To avoid explosion hazard, do not use the equipment in the presence of oxygen-rich atmospheres, flammable anesthetics, or other flammable agents (such as gasoline).  There is a battery inside. Do not open the equipment housings. All servicing and future upgrades must be carried out by the personnel trained and authorized by our company only.  Please don’t bend or reverse the ECG recorder. Otherwise the equipment may be damaged.  Remove the equipment from patients during defibrillation. Otherwise the equipment may be damaged.  Remove the equipment from patients during using the electro-surgery unit. Otherwise the equipment may be damaged.  When disposing of the package material, be sure to observe the applicable waste control regulations and keep it out of children’s reach.  Keep the equipment and accessories out of children’s reach. Otherwise children may inadvertently damage the equipment and accessories or swallow the same small parts casuing apnea or other hazards.  The equipment is suit for violent sports such as football, basketball and volleyball. The balls hit the equiepment that may hurt the user.  The equipment transmit wireless signal via sape. The signal may be interrupted by serval possible sources of interference. The transmission failure may happen sometime, although the equipment has some anti- interference capacity.
3 1.1.2 Cautions CAUTION  Make sure that the operating environment of the equipment meets the specific requirements.  To prolong the service life of the wquipment, please don’t put it under the sunshine for a long time.  To ensure patient safety, use only parts and accessories specified in this manual.  Single-use accessories are not designed to be reused. Reuse may cause a risk of contamination and affect the measurement accuracy.  At the end of its service life, the equipment, as well as its accessories, must be disposed of in compliance with the guidelines regulating the disposal of such products. If you have any questions concerning disposal of the equipment, please contact us.  Magnetic and electrical fields are capable of interfering with the proper performance of the equipment. For this reason make sure that all external devices operated in the vicinity of the equipment comply with the relevant EMC requirements. Mobile phone, X-ray equipment or MRI devices are a possible source of interference as they may emit higher levels of electromagnetic radiation. 1.1.3 Notes NOTES  Keep this manual in the vicinity of the equipment so that it can be obtained conveniently when needed.
4 1.2 Equipment Symbols General warning sign DATE OF MANUAFACTURE Serial number AUTHORISED REPRESENTATIVE IN THE EUROPEAN COMMUNITY The product bears CE mark indicating its conformity with the provisions of the Council Directive 93/42/EEC concerning medical devices and fulfils the essential requirements of Annex I of this directive. Note: The product complies with the Council Directive 2011/65/EU. Waterproof level 7 Refer to instruction manual/booklet Type CF APPLIED PART Non-ionization radiation symbol
1 2.Safety 2.1 Product introduction Wearable ECG monitor contain adhesive ECG recorder，ECG sensor. The adhesive ECG recorder collect ECG signal via ECG sensor. The data collected is stored in ECG recorder. It can be transmitted to protocol compatible device or APP. 2.1.1 Apply scope Can be used for measuring, recording and storing human ECG data, for applications that require long continuous records of patients ECG data. Can be used in medical departments or in home environment. WARNING  This equipment is used for single user at a time.  The PATIENT is an intended OPERATOR.  The ECG recorder is suitable for use within the patient environment.  The waterproof level of the ECG recorder is IPX7. It can be used in the shower or in water for a short time.  Prohibit using the equioment in the hyperbaric oxygen chamber. 1.2.1 Applied Parts TheappliedpartsofthewearableECGmonitorare: Shell of ECG recorder,  ECG electrodes  ECG sensor
2 2.2 Product appearance Picture 错误！文档中没有指定样式的文字。-1 Adhesive ECG recorder front Picture 错误！文档中没有指定样式的文字。-2 Adhesive ECG recorder back
1 3.Installation and Maintenance 3.1 Installation WARNING  The software copyright of the equipment is solely owned by us. No organization or individual shall resort to juggling, copying, or exchanging it or to any other infringement on it in any form or by any means without due permission. 3.1.1 Unpacking and Checking Before unpacking, examine the packing case carefully for signs of damage. If any damage is detected, contact the carrier or us. If the packing case is intact, open the package and remove the equipment and accessories carefully. Check all materials against the packing list and check for any mechanical damage. Contact us in case of any problem. NOTE  Save the packing case and packaging material as they can be used if the equipment must be reshipped. WARNING  When disposing of the packaging material, be sure to observe the applicable waste control regulations and keep it out of children’s reach.  The equipment might be contaminated during storage and transport. Before use, please verify whether the packages are intact, especially the packages of single use accessories. In case of any damage, do not apply it to patients / users.
2 1.2.2 Environmental Requirements The operating environment of the equipment must meet the Environmental Specification in Appendix B. 3.1.2 Power requirements The power used for this equipment must meet the Power Specification in Appendix B. WARNING  Make sure that the operating environment and power of the equipment meets the specific requirements. Otherwise unexpected consequences, e.g. damage to the equipment, could result. 3.1.3 Installation method Installation methods of adhesive ECG recorder, please refer chapter 4. 3.2 Cleaning and Disinfection Only adhesive ECG recorder and changer need cleaning and disinfection. The accessories are single use products. So they need not cleaning and disinfection. 3.2.1 Cleaning The ECG recorder should be cleaned beroe and after use. The charger should be cleaned beroe use. Please use clean and soft cloth, sponge or tampon adsorb non-erosive cleaning agent and dry appropriately to clean the surface of the equipment. Recommended cleaning agents are:  Water  Ethanol (70%)  Isopropyl alcohol (70%) To clean your equipment, follow these rules: 1. Clean the exterior surface of the equipment using a soft cloth dampened with the cleaner, making sure that no cleanser is dripping from the cloth. 2. Wipe off all the cleaning solution with a dry cloth after cleaning if necessary. 3. Dry your equipment in a ventilated, cool place.
3 WARNING  Please clean the surface under the rules abbove. Otherwise, it may damage the shell or the print of the equipement 3.2.2 Disinfection Disinfect the equipment as required in your hospital’s servicing schedule. Cleaning equipment before disinfecting is recommended.
1 4.Operations 4.1 Preparation before use Please shake the ECG recorder and observe the LED light before use.  The green light flicker means the ECG recorder is normal.  The red light flicker every 3 seconds means the ECG recorder is malfunction.  The red light flicker every 9 seconds means the ECG recorder is low power.  No light flicker means the ECG recorder is mal function or its battery uses out. NOTES  The ECG recorder need be waked up by charger before first use.  The battery will use out when the ECG recorder doesn’t use for a long time. It can not be waked up by shaking. It needs be charged before use.  It is ready to use when it is waked up and flicker greens light. The time is less than 15 seconds.  The time required for me equipment to warm from the minimum storage temperature between uses until it is ready for intended use is less than 30 minutes.  The time required for me equipment to cool from the maximum storage temperature between uses until it is ready for intended use is less than 30 minutes. 4.2 Wear the ECG recorder Picture 4-1 shows how to install accessory and wear the equipment on human body.
2 Picture 错误！文档中没有指定样式的文字。‐3ECG recorder installatiosketch map with one channel ECG sensor Installation process shows as below: 1.Tear off the tape marked①. 2.Stick the ECG recorder to the accessory. 3.Tear off the tape marked②. 4.Stick the ECG recorder with accessory nearby to heart such as A, B, C area in the picture. 5.Tear off the tape marked③. When use two channels ECG sensor, the operation is similar with one channel ECG sensor. The position shows as picture 4-2. 
3 Picture错误！文档中没有指定样式的文字。‐4ECG recorder installatiosketch map with two channel ECG sensor NOTES  The ECG recorder can work with one channel ECG sensor or two channel ECG sensor. Please use of accessories approved by Mindray.  Check the accessories and their packages for any sign of damage. Do not use them if any damage is detected. 4.3 View ECG data The ECG recorder can transmit data by Bluetooth. It can work with mobile equipment that is android 4.3 upwards, iOS 7.1 upwards, and Bluetooth 4.0 upwards. The ECG data can be read by protocol compatible APP’s. 4.4 Take off the ECG recorder 1.Take off the ECG recorder with ECG sensor from human body. 2.Tear off the ECG recorder from the ECG sensor 3.Put the ECG recorder to the original box. Picture 错误！文档中没有指定样式的文字。‐5 Take off the ECG recorder
4 NOTES  The ECG recorder will enter sleep mode. There is no need to power off it. 4.5 Charge the ECG recorder Please charge the ECG recorder under following conditions: First use There is no light indicator when shake the ECG recorder. Reuse the ECG recorder over one month between last use. Please charge it once every month to protect its battery, if it will not be used for a long time. Store it in a cool and dry place. You can check the battery volume on the APP and decide to charge or not basing on the intended using time. Recommend charging the ECG recorder when the battery volume is less than 10%. Show as picture 4-4, put the ECG recorder on the charger and connect the cable to DC 5V 500mA out put power. The blue light of ECG recorder will be on and the red light will flicker, when it is charging. The red light will go out when the battery is full. Picture错误！文档中没有指定样式的文字。‐6theindicatorsofcharger The charger indicator lights Battery volume indicator: Every light represents 25% volume. Charge indicator: This light turning on means the ECG recorder is charing. Data transimission indicator: This light flicker means the ECG recorder is sending data to the charger.
5 NOTES  The charger that model is EPC001 has no Battery volume indicator. Only can check the battery is full or not by ECG recorder’s indicator. 4.6 Offline data transimission The data stored in ECG recorder can be exported by Bluetooth of charger. A computer and export software are needed as well. You can get the download link by scanning the picture below. Connect the charger to the computer with thw USB cable. Then open the software. Put the ECG recorder to the charger. Operate the software following the instruction on the software. The data can be exported to computer by Bluetooth of charger and upload to cloud by internet. NOTES  The charger that model is EPC001 can not export data.
6 5.Frequence Questions Management 5.1 Frequence Questions Management Malfunction phenomena Possible cause resolvent Battery low volume Battery used out Charge ECG recorder Work time is short, only a couple of hours or minutes 1.Battery low volume 2.ECG recorder malfunction 1.Charge ECG recorder, then use. 2.Contact Manufacturer to fix it。 Bluetooth disconnection 1.Battery low volume 2.ECG recorder malfunction 3.Mobile equipement closed Bluetooth. 1.Charge ECG recorder, then use. 2.Contact Manufacturer to fix it。 3.Open bluetooth of mobile equipment.
1 6.Battery Adhesive ECG recorder has a rechargeable Lithium-ion battery as work power. The battery icon on Mindray health APP shows the volume status: When the remaining volume of battey is less than 10%, the red light on the ECG recorder will flash. The ECG recorder should be chargerd at this time. WARNING  Inside rechargeable Lithium-ion battery can not be replaced.  When charge, keep it out of children’s reach.  Only use the charger approved by Mindray.  To improve the life time of battery, please charge when indicating low volume.  Please charge to 80% upwards before longtime storage. And charge it once a month. Please don’t expose the battery to high temperature envirenment, such as warmer, oven, water heater and microwave oven. Battery overheating may explode.  Please don’t disasemble or modify the battery. Otherwise it may cause battery leakage, overheating, fire or explosion.  Keep skin and eyes from the leakage liquid, if the battery leakage. Please flush the skin or eyes immediately and go to hospital for treatment, if skin or eyes touch the leakage liquid.  Please don’t throw the battry into the fire. Otherwise it may cause explosion.  When a battery exceed lifetime , or no longer holds a charge, it should be disposed. To dispose of the batteries, follow local laws for proper disposal.  Please don’t let children or pets swallow or bite the battrey. Otherwise it may hurt them or cause explosion.
2 7.Accessory 7.1 ECG Sensor Theaccessoriesshowasthetablebelow.Thelifetimeoftheaccessoriesis2years.Part description model Type Manufacturer MR.Wear sigle channel ECG sensor EPA001 Sigle use Mindray MR.Wear two channels ECG sensor EPA002 Sigle use WARNING  Use accessories specified in this chapter. Using other accessories may cause damage to the equipment or not meet the claimed specifications.  Single-use accessories are not designed to be reused. Reuse may cause a risk of contamination and affect the measurement accuracy.  Check the accessories and their packages for any sign of damage. Do not use them if any damage is detected.  The accessory material that contacts the patients has undertaken the bio-compatibility test and is verified to be in compliance with ISO 10993-1.  The accessory can not be pasted on the damaged skin. Otherwise it may cause dermatitis.  Don’t stick the accessory in the same position time by time for a long time. It may cause dermatitis. CAUTION  Please store the ECG sensor in dark shade under the room temperature.  Please use the ECG sensor as soon as possible after the package is open. Otherwise the water evaporation of ECG sensor will impact its performance.  Check the ECG sensor is not expired before use.
3  Please close the package after getting ECG sensor. 7.2 Charger Part description model Type Manufacturer ECG Recorder Charger EPC001 Repeat use Mindray ECG Recorder Charger (Professional) EPC002 Repeat use WARNING  Please select a computer or adapter that fulfills IEC60950 or related industry safety standards to supply the charger.  Only use the charger approved by Mindray. The charger complies with the requirements of IEC60601-1.  The metal material stuff can not be placed on the charger. The charger can not use for other device except the ECG recorder.  Don’ touch the user when touch the charger and USB cable during the charger conneting to the power.
A-1 A Product Specifications A.1 Safety Specifications The ECG recorder is classified, according to IEC60601-1: Type of protection against electrical shock Class I, equipment energized from an internal electrical power source. Degree of protection against electrical shock Type CF Mode of operation Continuous Degree of protection against harmful ingress of water IPX7 A.2 Environmental Specifications WARNING  The equipment may not meet the performance specifications if stored or used outside the specified temperature and humidity ranges. Item Operating conditions Storage conditions Temperature (°C) 0 to 45 -20 to 45 Relative humidity (noncondensing) 15% to 95% 10% to 95% Barometric (kPa) 86.0 to 106.0 57.0 to 107.0 A.3 Power Supply Specifications Battery voltage range 3-4.2V Battery Type Chargeable Lithium-Ion, 11.1DVC, 4.5 Ah Run time (type value) ≥ 30 hours
A-2 A.4 Physical Specifications Size Length：87±5mm Width：32±3mm Height：6±1mm Weight ≤10g Interface Standard interface, include ECG leads signals and Bluetooth signal A.5 Display, Recorder and Storage Specification Display A least one lead ECG wave and equipment status information will be display on mobile phone or other mobile device. Recorder mode Real time record Storage mode Chip storage Storage capacity Storage 30 hours data A.6 ECG Specification ECG Lead set 3-lead: I, III Sample rate 125Hz Input signal range ±8 mV (peak-to-peak value) Pace pulse markers Pace pulses meeting the following conditions are labelled with a PACE marker: Amplitude: ±2 to ±200 mV Width: 0.1 to 2 ms Rise time: 10 to 100 µs Common mode rejection ratio ≥96dB Bandwidth (-3dB) 0.05~40Hz Gain setting error≤±5% Display sensitivity Accuracy: ±5% Differential input impedance ≥20MΩ@10Hz A.7 Charger Specification Interface Standard interface, micro USB Input DC 5V 200mA Output DC 5V 40mA
B-1 B EMC and Radio Regulatory Compliance B.1 EMC The device meets the requirements of IEC 60601-1-2. NOTE  Using accessories, transducers and cables other than those specified may result in increased electromagnetic emission or decreased electromagnetic immunity of the device.  The device or its components should not be used adjacent to or stacked with other equipment. If adjacent or stacked use is necessary, the device or its components should be observed to verify normal operation in the configuration in which it will be used.  The device needs special precautions regarding EMC and needs to be installed and put into service according to the EMC information provided below.  Other devices may interfere with this device even though they meet the requirements of CISPR.  When the inputted signal is below the minimum amplitude provided in technical specifications, erroneous measurements could result.  Portable and mobile communication equipment may affect the performance of this monitor.  Other devices that have RF transmitter or source may affect this device (e.g. cell phones, PADs, PCs with wireless function). Guidance and Declaration - Electromagnetic Emissions The device is intended for use in the electromagnetic environment specified below. The customer or the user of the device should assure that it is used in such an environment. Emission tests Compliance Electromagnetic environment - guidance Radio frequency (RF) emissions CISPR 11 Group 1 The device 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.
B-2 RF emissions CISPR 11 Class B The device is suitable for use in all establishments , domestic and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes Harmonic emissions IEC61000-3-2 Not apply / Voltage Fluctuations/Flicker Emissions IEC 61000-3-3 Not apply If the system is operated within the electromagnetic environment listed in Table Guidance and Declaration —Electromagnetic Immunity, the system will remain safe and provide the following essential performance,  Operating mode  Accuracy  Function  Accessories identification  Data stored  Alarm  Detect for connection Guidance and Declaration - Electromagnetic Immunity The device is intended for use in the electromagnetic environment specified below. The customer or the user of the device should assure that it is used in such an environment. Immunity test IEC60601 test level Compliance level Electromagnetic environment - guidanceElectrostatic 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 ±2 kV for power supply lines ±1 kV for input/output lines ±2 kV for power supply lines Mainspowerqualityshouldbethatofatypicalcommercialorhospitalenvironment.
B-3 Surge IEC 61000-4-5 ±1 kV line(s) to line(s) ±2 kV line(s) to earth Not apply 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 Not apply / Power frequency (50/60 HZ) magnetic field IEC 61000-4-8 3 A/m 3 A/m Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment. Note: UT is the AC mains voltage prior to application of the test level. Guidance and Declaration - Electromagnetic Immunity The device is intended for use in the specified electromagnetic environment. The customer or the user of the device should assure that it is used in such an environment as described below. Immunity test IEC60601 test level Compliance level Electromagnetic environment - guidance Conduced RF IEC61000-4-6 3 Vrms 150 kHz to 80 MHz 3 Vrms Portable and mobile RF communications equipment should be used no closer to any part of the system, including cables, than the recommended separation distance calculated from the equation appropriate for the frequency of the transmitter. Recommended separation distances: Pd 2.1 Radiated RF IEC61000-4-3 3V/m 80MHz to 2.5GHz 3V/m Recommended separation distances: 80 MHz～800 MHz Pd 2.1 800MHz-2.5GHz
B-4 Pd 3.2 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).b 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 equipment marked with the following symbol: Note 1: At 80 MHz to 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. Note 3: The device that intentionally receives RF electromagnetic energy at the exclusion band (2400MHz-2483.5MHz) is exempt from the ESSENTIAL PERFORMANCE requirements, but remains safe. 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 [ME EQUIPMENT or ME SYSTEM] is used exceeds the applicable RF compliance level above, the [ME EQUIPMENT or ME SYSTEM] should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the [ME EQUIPMENT or ME SYSTEM]. b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than3V/m. Recommended separation distances between portable and mobile RF communications equipment and the device The device is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the device can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the device as recommended below, according to the maximum output power of the communications equipment. Rated maximum output power Separation distance in meters (m) according to frequency of the transmitter 150 kHz ～ 80 MHz 80 MHz ～ 800 MHz 800 MHz ～ 2.5 GHz
B-5 of transmitter（W） Pd 2.1 Pd 2.1 Pd 3.2 0.01 0.12 0.12 0.23 0.1 0.38 0.38 0.73 1 1.20 1.20 2.30 10 3.80 3.80 7.30 100 12.00 12.00 23.00 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. 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.
B-6 B.2 Radio Regulatory Compliance RFparametersItem Description Bluetooth low energy 4.1 Operating Frequency Band (MHz) 2402 - 2480 Modulation GFSK Transmitter Output Power (dBm) ≤2.5 ThedeviceincludingBluetoothmodulewhichcomplieswithpart15oftheFCCRules.Operationissubjecttotheconditionthatthisdevicedoesnotcauseharmfulinterference.OperationofthisequipmentrequiresthepriorcoordinationwithafrequencycoordinatordesignatedbytheFCCfortheWirelessMedicalTelemetryService.ThisBluetoothdevicecomplieswithCanadianICES‐001.CetappareilISMestconformealanormeNMB‐001duCanada.ThedeviceincludingBluetoothmoduleFCCandIndustryCanadaRadioCompliance:ThisdevicecomplieswithPart15oftheFCCRulesandRSS‐210ofIndustryCanada.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.AnychangesormodificationstothisequipmentnotexpresslyapprovedbyMindraymaycauseharmfulradiofrequencyinterferenceandvoidyourauthoritytooperatethisequipment.Themaximumantennagainpermittedcomplieswiththee.i.r.p.limitsasstatedinRSS‐210.Themaximumantennagainpermittedcomplieswiththee.i.r.p.limitsspecifiedforpoint‐to‐pointoperation,asstatedinRSS‐210.TheradiodeviceusedinthisproductisincompliancewiththeessentialrequirementsandotherrelevantprovisionsofDirective1999/5/EC(RadioEquipmentandTelecommunicationsTerminalEquipmentDirective).
C-1 C Symbols and Abbreviations C.1 Symbols A ampere dB decibel g gram Hz hertz k kilo kPa kilopascal m meter mm millimeters ms millisecond mV millivolt mW milliwatt s second V volt Ω ohm W watt － minus % percent / per; divide; or ～ to ^ power ＋ plus ＝ equal to ＜ less than ＞ greater than ≤ less than or equal to ≥ greater than or equal to ± plus or minus × multiply © copyright
C-2 C.2 Abbreviations ECG electrocardiograph MDD Medical Device Directive MRI magnetic resonance imaging
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