Table of Contents
Advertisement
Version
Date
Shenzhen Viatom Technology
Co., Ltd.
Author
© ViATOM TECHNOLOGY (UNPUBLISHED) ALL RIGHTS RESERVED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.
Description
Manual( Dynamic
ECG recorder)
Document Number
41-DO-00281
Review
I
Author
User's
Approval
Reversion
A
Advertisement
Table of Contents
Subscribe to Our Youtube Channel
Related Manuals for Viatom ER1
Summary of Contents for Viatom ER1
- Page 1 Review Approval © ViATOM TECHNOLOGY (UNPUBLISHED) ALL RIGHTS RESERVED This material is the proprietary information of ViATOM Technology.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.
- Page 2 User’s Manual ER1 Dynamic ECG recorder Contents The basics..................1 Introduction...................3 Using Instructions................6 Maintenance ..................9 Accessories..................11 Specifications................11 Electromagnetic compatibility............11...
- Page 3 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 device. 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 ...
- Page 5 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.
- Page 6 2.1.1 Contraindications: The product is not intended for use in patients with cardiac pacemakers or other implantable devices. 2.2 About ER1 1. Right sign When wearing, the side marked "R" should be on the right hand side of the wearer.
- Page 7 3. Power interface contacts Used to connect charging cables. 4. Electrode buckle Used to connect chest straps, disposable ECG electrodes or\charging cables. 2.3 Symbols Symbol Significance Type BF-Applied Part Manufacturer Authorized representative in the European Community This product complies with the Europea Council Directive 0197 93/42/EEC(Medical Device Directive)
- Page 8 2.4 Product structure and composition This product is mainly composed of Dynamic ECG recorder main unit, OTG adapter, charging cable and strap Chest (optional).Disposable ECG electrode(optional). 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 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. Please confirm that the packaging is in good condition before use.
- Page 10 2、Chest Strap measurement method: Attach the main unit to the strap and then wear the Chest strap with the main unit attached to the precordium (The marked with the English letter "R" is on the right hand side of the wearer.) as shown below.
- Page 11 2)The duration of a measurement is 5 minutes to 72 hours. If you want to end the measurement, please remove the Disposable ECG electrodes or unfasten the chest strap to remove the device. After 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.
- Page 12 80h of measurement data .In order to ensure that every data you collect is able to be viewed smoothly, please export the 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.
- Page 13 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. 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...
- Page 14 for treatment. Do not throw the battery into a fire. Doing so may cause an explosion. When the battery exceeds the service life or no longer holds the power, you should contact the manufacturer for disposal.To dispose of the battery, follow local laws for proper disposal.
- Page 15 The device 1. The battery is 1. Please charge the cannot device perform 2. Equipment 2. Please contact normal damage your local agent acquisition 1. Please re-measure according to the 1. Measurement ECG waveform recommendations of method is is disordered, the manual incorrect and the clutter...
- Page 16 4、Disposable ECG electrodes should not be attached to patients with traumatized or scarred skin. 5、Disposable ECGelectrodes should be in close contact with the skin. If itching or skin irritation or ulceration occurs, stop using it immediately.
- Page 17 Specifications Classification MDD, 93/42/EEC EC Directive R&TTE, 2014/53EU ROHS 2.0, 2011/65/EU Degree protection against Type BF electrical shock Environmental Item Operating Storage Temperature 5 ~ 45°C -25 ~ 60°C Relative humidity 10% ~ 95% 10% ~ 95% (non-condensing) Atmospheric pressure 700 ~ 1060 hPa 700 ~ 1060 hPa Degree of dust&water...
- Page 18 Maximum error ±10% Gain error Physical Size 100×23×8.5 mm Packing size 172×113×59mm weight <20 g (with battery) Wireless connectivity Bluetooth connection support Built-in Bluetooth 4.0 BLE 5 year XPECTED SERVICE LIFE FCC Warnning: FCC ID:2ADXK-3613 Any Changes or modifications not expressly approved by the party responsible for compliance could void the user's authority to operate the equipment.
- Page 19 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.
- Page 20 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 21 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. The customer or the user of The model Dynamic ECG recorder can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and The model Dynamic ECG recorder as recommended below, according to the...
- Page 22 Recommended separation distances between RF wireless 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.
- Page 23 should be less than the 2450 compliance level in each 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.
- Page 24 where P is the maximum output power rating of the transmitter in watts (W) according 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...
- Page 25 The model Dynamic ECG recordershould be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting 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 –...
- Page 26 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: ER1 Revision date: April 2020...
Need help?
Do you have a question about the ER1 and is the answer not in the manual?
Questions and answers