Dynamic ECG recorder (Model:ER1-LB、ER1-LW) Contents 1. The basics.....................................................................................1 2. Introduction.................................................................................. 3 3. Using Instructions................................................................................6 4. Maintenance................................................................................... 9 5. 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.
Do not strongly collide or crush the device. If the casing is 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.
without prior permission. This device is not a substitute for professional heart or other organ function measurement equipment. Medical ECG measurement requires more professional and complete measurements. This device cannot be used to diagnose a disease directly.Please consult your doctor. We recommend that you record your ECG curve and the results of the measurements and provide them to your doctor if necessary.
2. Introduction 2.1 Product Name:Dynamic ECG recorder Model: ER1-LB、ER1-LW. No. Model 1 2 ER1-LW ER1-LB Enclosure Color White Black 2.2 Intended Use The product is intended to measure, review and store adults’ ECG data at home or in healthcare environment, does not contain auto-analysis function. The product continuously records and stores ECG and activity data for at least 3 days at a time.
2.2.1 Contraindications: The product is not intended for use in patients with cardiac pacemakers or other implantable devices. 2.3 About ER1-LB、ER1-LW ① Right sign When wearing, the side marked "R" should be on the right hand side of the wearer. ②Display screen The display displays the device's power, heart rate, charging status and other information. ③Power interface contacts Be used to connect charging cable.
2.4 Symbols Symbol Significance Type BF-Applied Part Manufacturer 0197 IP22 Authorized representative in the European Community This product complies with the EU 2017/745 (MDR) Caution，Incorrect use may cause personal injury and damages of goods. Refer to instruction manual. Protected against spraying water and against access to hazardous parts with a tool, per IEC 60529. Follow Instructions for Use.
3. UsingInstructions 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. This device has no alarm function and therefore does not generate an audible alarm for the result of the measurement. Ungrounded equipment next to the patient and interference from electrosurgery can cause waveform instability. 3.
and place the packaging materials out of reach of children. The device may be contaminated by microorganisms during storage, transportation and use. Please confirm that the packaging is in good condition before use. The date of manufacture and the date of use of the product are listed on the label.
3.3 Boo t When the device is shipped from the factory, it is completely inactive by default.The device should be charged to activate the device before it is used for the first time. 3.4 Measuringprocess 3.4.1 Measurement methods 1、ECG electrode wearing method: Remove the packaging of the single-use ECG electrode, install the ECG electrode on the device through the electrode buckle, and wear the Dynamic ECG recorder with the ECG electrode on the chest as shown in the figure.
Figure 3 Precautions: a. Before use, please check whether the single-use ECG electrode is within the validity period. b. The ECG electrode must be in direct contact with the skin. c. Before wearing, if necessary, remove the hair on the electrode part, then clean the skin with clean water, and dry it before attaching the ECG electrode d.
1 minute, the device completes data storage. 3)When the test is less than 5 minutes, there is no data to save, and more than 5 minutes will be saved. When the continuous measurement time is 168 hours, the measurement will be ended and the data will be saved. 3.5 Data export function After the measurement is completed, the data measured in the device can be transmitted to the mobile equipment for viewing by Bluetooth.
Figure 4 Warnings and Cautionary Advices 4. The device cannot be used during charging, and if choosing a third party charging adaptor (Class II ), select one that complies with IEC60950 or IEC60601-1. Keep out of reach when charging. When the long-term storage is not in use, it is necessary to periodically charge the device to maintain battery performance.
When the remaining battery power is low, the indicator light will turn yellow and flash, and the device needs to be charged. Warnings and Cautionary Advice The built-in rechargeable lithium-ion battery cannot be replaced.Non-professionals cannot open the enclosure and modify or replace the battery. Do not expose the main unit to high temperatures such as ovens,water heaters and microwave ovens. Overheating of the battery may explode. Do not contaminate or modify the battery.
with 70% medical alcohol or water. At the same time, disposable ECG stickers cannot be mixed and must be replaced. 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. When it is intended to discard this device, it must be sent to the appropriate facility for recycling and recycling. 4.
5. accessories Serial number 1 Accessory name Charging cable Quantity 1 2 3 Chest Strap (optional) Disposable ECG electrodes (optional) 1 2 Warnings and Cautionary Advice 1、Use only the accessories specified in this manual, and using other accessories may damage the device. 2、Check if the disposable ECG electrode has expired before use.
6 Specifications Classification EC Directive Degree protection against electrical shock Environmental MDR, EU 2017/745 R&TTE, 2014/53EU ROHS 2.0, 2011/65/EU Type BF Item Temperature Relative humidity (noncondensing) Atmospheric pressure Degree of dust&water resistance Operating 5 ~ 45°C Storage -25 ~ 60°C 10% ~ 95% 10% ~ 95% 700 ~ 1060 hPa 700 ~ 1060 hPa Drop test 1.0 m Type of battery Battery specification Rechargeable lithium polymer battery 3.
Common mode rejection Frequency response ≥60dB 0.67 ~ 40 Hz Gain error Maximum error ±10% Physical Size Packing size 100×23×8.5 mm 172×113×59mm weight <20 g (with battery) Wireless connectivity Bluetooth connection support Built-in Bluetooth 4.0 BLE 5 year EXPECTED SERVICE LIFE FCC Warnning: FCC ID:2ADXK-3614 Any Changes or modifications not expressly approved by the party responsible for compliance could void the user's authority to operate the equipment.
determined by turning the equipment off and on, the user is encouraged to try to correct the interference by one or more of the following measures: -Reorient or relocate the receiving antenna. -Increase the separation between the equipment and receiver. -Connect the equipment into an outlet on a circuit different from that to which the receiver is connected. -Consult the dealer or an experienced radio/TV technician for help. The device has been evaluated to meet general RF exposure requirement.
8Electromagnetic 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.
Recommended separation distances between portable and mobile RF communications equipment and the A&D unit The model Dynamic ECG recorder is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled.
Recommended separation distances between RF wireless communicationsequipment 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.
2450 2 0.3 28 28 0.2 0.3 9 9 5240 5500 should be less than the compliance level in each 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.
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 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.
The model Dynamic ECG recordershould be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating The model Dynamic 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 Dynamic ECG recorder is intended for use in the electromagnetic environment specified below.
ER1-LW、ER1-LB Dynamic ECG recorder Shenzhen Viatom Technology Co., Ltd 4E, Building3, Tingwei Industrial Park,NO.6 Liufang Road,Block 67 Xin’an Street,Baoan District Shenzhen 518101 Guangdong 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.
