Version Date Description Author User's Manual( Dynamic ECG recorder) Shenzhen Viatom Technology Co., Ltd. Document Number Reversion 41-DO-00281 Author Review A Approval © ViATOM TECHNOLOGY (UNPUBLISHED) ALL RIGHTS RESERVED This material is the proprietary information of ViATOM Technology.
User’s Manual ER1 Dynamic 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.
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 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.
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. Waste (including the equipment itself is scrapped) is disposed of in accordance with relevant laws and regulations.
The product continuously records and stores ECG and activity data for up to 3 days at a time. 2.1.1 Contraindications: The product is not intended for use in patients with cardiac pacemakers or other implantable devices. 2.2 About ER1 2 1 3 4 4 1. Right sign When wearing, the side marked "R" should be on the right hand side of the wearer. 2.
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 0197 IP22 Authorized representative in the European Community This product complies with the Europea Council Directive 93/42/EEC(Medical Device Directive) Caution ， Incorrect use may cause personal injury and damages of goods. Refer to instruction manual.
2.4 Product structure and composition This product is mainly composed of Dynamic ECG recorder main unit, OTG adapter, charging cable and Chest strap (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. Use only the cables and accessories specified in this manual.
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. The date of manufacture and the date of use of the product are listed on the label. 3.3 Boot When the device is shipped from the factory, it is completely inactive by default.
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. 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.
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. When the continuous measurement time is 72 hours, the measurement will be ended and the data will be saved. 3.
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. Charging specific steps: 1. Place the main 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.
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 workmanship within warranty period when used in accordance with the provided instructions. 4.
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. 4.3 Cleaning Dynamic 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 70% medical alcohol or water.
The device cannot perform normal acquisition 1. The battery is low 2. Equipment damage 1. Please charge the device 2. Please contact your local agent ECG waveform is disordered, and the clutter is large 1. Measurement method is incorrect 2. Poor contact of ECG electrode 1. Please re-measure according to the recommendations of the manual 2. Please clean the ECG electrode according to the method described in the manual. 5.
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.
7 Specifications Classification EC Directive MDD, 93/42/EEC R&TTE, 2014/53EU ROHS 2.
Gain error Maximum error ±10% 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 Physical EXPECTED 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. This device complies with part 15 of the FCC Rules.
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. The device can be used in portable exposure condition without restriction.
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.
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 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.
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 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 – electromagnetic immunity The model Dynamic ECG recorder is intended for use in the electromagnetic environment specified below.
ER2 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.
