Wearable ECG Monitor Operator’s Manual I
© Copyright 2014-2016 Shenzhen Mindray Bio-Medical Electronics Co., Ltd. All rights reserved. For this Operator’s Manual, the issue date is 2016-4.
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.
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.
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.
Contents 1.1.1 Warnings ............................................................................................................... 2 1.1.2 Cautions ................................................................................................................ 3 1.1.3 Notes ..................................................................................................................... 3 1.2 Equipment Symbols ..........................................................................................
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.
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.
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.
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.
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.
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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.
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.
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.
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.
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.
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.
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.
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.
5.Frequence Questions Management 5.1 Frequence Questions Management Malfunction Possible cause resolvent Battery used out Charge ECG recorder 1.Battery low volume 1.Charge ECG recorder, then use. 2.ECG recorder malfunction 2.Contact Manufacturer to fix it。 1.Battery low volume 1.Charge ECG recorder, then use. Bluetooth 2.ECG recorder malfunction 2.Contact Manufacturer to fix it。 disconnection 3.Mobile equipement closed 3.
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.
7.Accessory 7.1 ECG Sensor The accessories show as the table below. The lifetime of the accessories is 2years. Part description MR.Wear sigle channel ECG sensor model Type EPA001 Manufacturer 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.
Please close the package after getting ECG sensor. 7.2 Charger Part description model ECG Recorder Charger EPC001 Type Manufacturer Repeat use Mindray ECG Recorder Charger (Professional) Repeat use EPC002 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.
A Product Specifications A.1 Safety Specifications The ECG recorder is classified, according to IEC60601-1: Type of protection against electrical Class I, equipment energized from an internal electrical shock power source. Degree of protection against electrical shock Type CF Continuous Mode of operation Degree of protection against harmful ingress of water IPX7 A.
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.
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.
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 Not apply / IEC61000-3-2 Voltage Fluctuations/Flicker Not apply Emissions IEC 61000-3-3 If the system is operated within the electromagnetic environment listed in Table Guidance and Declaration —Electromagnetic Immunity, the system will remain safe and provide th
Surge IEC ±1 kV line(s) to line(s) 61000-4-5 ±2 kV line(s) to earth Voltage dips, short <5 % UT (>95 % dip in interruptions and UT) for 0.
d 2 .3 P 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.
of transmitter d 1 . 2 P （W） d 1 .2 P d 2 .3 P 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.
B.2 Radio Regulatory Compliance RF parameters Item Operating Frequency Band (MHz) Modulation Transmitter Output Power (dBm) Description Bluetooth low energy 4.1 2402 - 2480 GFSK ≤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.
C Symbols and Abbreviations C.
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