Viatom ER2 Manual

Ecg recorder

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User's Manual(ECG

recorder)

Document Number

Reversion

Shenzhen Viatom Technology

Co., Ltd.

42-DO-00281

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ViATOM

TECHNOLOGY

(UNPUBLISHED)

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This material is the proprietary information of ViATOM Technology. And

any use, reproduction, or distribution of the material contained herein, unless

specifically authorized by ViATOM Technology, is expressly forbidden and

would violate the rights and interests of ViATOM Technology.

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Page 1 (UNPUBLISHED) RIGHTS RESERVED This material is the proprietary information of ViATOM Technology. And any use, reproduction, or distribution of the material contained herein, unless specifically authorized by ViATOM Technology, is expressly forbidden and would violate the rights and interests of ViATOM Technology.
Page 2: Table Of Contents
User’s Manual ER2 ECG recorder Contents The basics..................1 Introduction................... 3 Using Instructions................6 Maintenance .................. 9 Accessories..................11 Specifications................11 Electromagnetic compatibility............11...
Page 3: The Basics
The basics 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. 1.1 Safety Warnings and Cautionary Advices Before using this equipment, please read this manual...
Page 4 broken, stop using it. This device cannot be placed in a pressure vessel or gas  sterilization equipment. Do not disassemble the device at will, otherwise it may  cause machine malfunction or affect the normal operation of the device. Keep this device out of the reach of children or pets、...
Page 5: Introduction
We recommend that you record your ECG curve and the  results of the measurements and provide them to your doctor if necessary. Waste (including the equipment itself is scrapped) is  disposed of in accordance with relevant laws and regulations.
Page 6 2.2 About ER2 Figure 1 ECG electrode It is used to connect the body surface and receive the human body ECG signal. LED indicator Off: The device is not activation or battery is run out, Green : the lead is off;...
Page 7 is in normal standby mode; Blue and flash(According to patient heart rate rhythm): The device is working normally and The device is in Bluetooth connection. Charging interface Used to connect the charging cable. Charging base For the product to charge. 2.3 Symbols Symbol Significance...
Page 8: Using Instructions
2.4 Product structure and composition This product is mainly composed of ECG recorder main unit, charging base, charging cable and strap (optional). 2.5 Software information Software name: ECG recorder software Release version： V1.0 3. Using Instructions 3.1 Before use Warnings and Cautionary Advices Before taking measurements, please pay attention to the following points to ensure the accuracy of the measurement data.
Page 9 complete items. If you have any questions, please contact us immediately. Warnings and Cautionary Advices Please save the box and packing materials for future  transportation or storage. When handling packaging materials, you must follow local  regulations or the hospital's waste disposal system and place the packaging materials out of reach of children.
Page 10 Figure 2 Wrong way of operation: a. Shake your hands at will b. Loose fingers during measurement 2）Strap measurement method: Attach the main unit to the strap and then wear the strap with the main unit attached to the precordium (the indicator light is facing up) as shown below.
Page 11 remove the hair from the electrode part, then clean the skin with water, and then apply the electrode after drying. e. Do not speak and remain still during the measurement. Any movement will affect the measurement results. f. Please sit when measuring possible. 3.4.2 Measuring step 1）After selecting a measurement method, the device detects that the ECG signal is automatically turned on, the signal light...
Page 12 data in time after each measurement is completed. 3.6 Charging This device uses a rechargeable lithium battery.charged by connecting a laptop or a power adapter with charging cable. Charging specific steps: 1. Place the main unit on the charging base and connect the charging base through the charging cable.As shown below.
Page 13: Maintenance
4. Maintenance Warnings and Cautionary Advices Have the device repaired by authorized service centers only, otherwise its warranty is invalid 4.1 Warranty The product is warranted to be free from defects in materials and workmanship within warranty period when used in accordance with the provided instructions.
Page 14 proper disposal. 4.3 Cleaning ECG recorder and straps need to be cleaned regularly;clean the device per week. carefully swabbing the device with a clean, soft cloth or cotton ball with medical alcohol or water. 4.4 Recycling Disposal of waste, residues, etc., as well as device and accessories at the end of their useful life shall not be disposed of at random and shall be in accordance with local regulations.
Page 15: Accessories
accessories Serial number Accessory name Quantity Charging base Charging cable Strap (optional) Warnings and Cautionary Advices Use only the accessories specified in this manual, and  using other accessories may damage the device.
Page 16: Specifications
Specifications Classification Degree protection against Type CF electrical shock Protection against electric Internally powered equipment shock Electro-magnetic Group I, Class B Compatibility Apply part ECG electrode Environmental Item Operating Storage Temperature 5 ~ 45°C -25 ~ 70°C Relative humidity 10% ~ 95% 10% ~ 95% (non-condensing) Atmospheric pressure...
Page 17 Common mode rejection ≥60dB Frequency response 0.67 ~ 40 Hz Gain error Maximum error ±10% Physical Size 92×32×8.2 mm Packing size 172×113×59mm weight <50 g (with battery) Wireless connectivity Bluetooth connection support Built-in Bluetooth 4.0 BLE Expected service life 5 year Bluetooth RF Frequency range 2.402-2.480 GHz...
Page 18: Electromagnetic Compatibility
8 Electromagnetic compatibility The device meets the requirements of IEC 60601-1-2. Warnings and Cautions • This device should not be used in the vicinity or on the top of other electronic equipment such as cell phone, transceiver or radio control products. If you have to do so, the device should be observed to verify normal operation.
Page 19 The model ECG recorder is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of The model ECG recorder can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and The model ECG recorder as recommended below, according to the maximum output power of the communications equipment.
Page 20 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 RF wireless communications equipment and the device as recommended below, according to the maximum output power of the communications equipment.
Page 21 frequency range. 5240 Interference may occur in the vicinity of equipment 5500 marked with the following symbol: 5785 Note 1: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. Guidance and manufacturer’s declaration –...
Page 22 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: NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies.
Page 23 model ECG recorder d Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m. Guidance and manufacturer’s declaration – electromagnetic immunity The model ECG recorder is intended for use in the electromagnetic environment specified below. The customer or the user of The model ECG recorder should assure that it is used in such an environment.
Page 24 Borkstrasse 10 · 48163 Muenster · Germany TEL: +49 251 32266-0 FAX: +49 251 32266-22 0197 PN：255-01918-00 Version: A Contents of this manual are subject to changes without prior notice. ©Copyright 2018 Shenzhen Viatom Technology Co., Ltd. All rights reserved. Model: ER2 Revision date: July 2019...
Page 25 FCC Warnning: Any Changes or modifications not expressly approved by the party responsible for compliance could void the user's authority to operate the equipment. 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.

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