Version Date Description Author User's Manual(ECG recorder) Document Number Shenzhen Viatom Technology Co., Ltd. Reversion 42-DO-00281 Author Review A Approval © ViATOM TECHNOLOGY (UNPUBLISHED) ALL RIGHTS RESERVED This material is the proprietary information of ViATOM Technology.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.
User’s Manual ER2 ECG recorder Contents 1. 2. 3. 4. 5. 6. 7. The basics...................................................................................... 1 Introduction................................................................................... 3 Using Instructions............................................................................ 6 Maintenance .................................................................................. 9 Accessories...............................................
1. 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 carefully and fully understand the warnings and risks.
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、pests. This device should not be used on people with sensitive skin or allergies.
2. 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. When the ambient temperature is 20 ℃, the minimum and maximum storage temperature from the product to ready for use is 2H（the time required）. The patient is the expected user.
2.2 About ER2 1 4 1 3 2 1. 2. Figure 1 ECG electrode It is used to connect the body surface and receive the human body ECG signal.
3. 4. 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.
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. Use only the cables and accessories specified in this manual.
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. The device may be contaminated by microorganisms during storage, transportation and use.
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. Figure 3 Precautions: a. The ECG electrode must be in direct contact with the skin. b. If the patient is exposed to dry skin, wipe the skin with a damp cloth before measuring. c.
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.
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. 2. Connect the charging cable to the usb port with 5v output voltage for charging.
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. 4.2 Battery When the remaining battery power is low, the indicator light will turn yellow and flash, and the device needs to be charged.
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.
5. accessories Serial number 1 2 3 Accessory name Charging base Charging cable Strap (optional) Quantity 1 1 1 Warnings and Cautionary Advices Use only the accessories specified in this manual, and using other accessories may damage the device.
7 Specifications Classification Degree protection against electrical shock Protection against electric shock Electro-magnetic Compatibility Apply part Type CF Internally powered equipment Group I, Class B ECG electrode Environmental Item Temperature Relative humidity (non-condensing) Atmospheric pressure Degree of dust&water resistance Drop test Operating 5 ~ 45°C Storage -25 ~ 70°C 10% ~ 95% 10% ~ 95% 700 ~ 1060 hPa 700 ~ 1060 hPa IP22 1.
Common mode rejection Frequency response Gain error ≥60dB 0.67 ~ 40 Hz Maximum error ±10% Physical Size Packing size 92×32×8.2 mm 172×113×59mm weight <50 g (with battery) Wireless connectivity Bluetooth connection support Built-in Bluetooth 4.0 BLE 5 year Expected service life Bluetooth RF Frequency range 2.402-2.480 GHz GFSK Modulation Wireless Quality of Service (QoS) Transmission Distance: 1.
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.
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.
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. Frequen cy MHz Maxim um Power W Distan ce IEC 60601 Test Level Compl iance Level 385 1.8 0.3 27 27 450 2 0.
5240 5500 0.2 0.3 9 9 frequency range. Interference may occur in the vicinity of equipment 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 – electromagnetic immunity The model ECG recorder is intended for use in the electromagnetic environment specified below.
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, 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 and 800 MHz, the higher frequency range applies. NOTE 2 These guidelines may not apply in all situations.
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.
ER2 ECG recorder Shenzhen Viatom Technology Co., Ltd 4E, 3#, Tingwei Industrial Park, Honglang North 2nd Road, Baoan District, Shenzhen, China www.viatomtech.com MedNet GmbH 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.
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.
