Mindray EPA001 Operator'S Manual Download Page 34

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C-2

C.2

Abbreviations

ECG

electrocardiograph

MDD

Medical Device Directive

MRI

magnetic resonance imaging

Summary of Contents for EPA001

Page 1: ...I Wearable ECG Monitor Operator s Manual ...

Page 3: ...rademarks 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 t...

Page 4: ...r 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 Comp...

Page 5: ... 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 n...

Page 6: ... 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 Spec...

Page 7: ...ot 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 ...

Page 8: ...corder 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 eq...

Page 9: ...ccessories 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 ...

Page 10: ... 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 ...

Page 11: ...hat 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 th...

Page 12: ...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 ...

Page 13: ...tact 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 regulation...

Page 14: ...rder 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 clea...

Page 15: ... 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 ...

Page 16: ...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 T...

Page 17: ...Tear off the tape marked 2 Stick the ECG recorder to the accessory 3 Tear off the tape marked 4 Stick the ECG recorder with accessory nearby to heart such as A B C area in the picture 5 Tear off the tape marked When use two channels ECG sensor the operation is similar with one channel ECG sensor The position shows as picture 4 2 ...

Page 18: ...t 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...

Page 19: ... 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 i...

Page 20: ...rger 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 charg...

Page 21: ...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 ...

Page 22: ...t 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 hosp...

Page 23: ...ement 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 t...

Page 24: ...ct 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 charg...

Page 25: ...tion 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 ...

Page 26: ...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...

Page 27: ...th 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 G...

Page 28: ...tion 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 guidance Electrostatic discharge ESD IEC 61000 4 2 6...

Page 29: ...el 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 mo...

Page 30: ...redicted 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 performan...

Page 31: ...es 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 absorp...

Page 32: ... 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 ra...

Page 33: ... 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 ...

Page 34: ...C 2 C 2 Abbreviations ECG electrocardiograph MDD Medical Device Directive MRI magnetic resonance imaging ...

Page 35: ...C 1 ...

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