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User Manual for Shenzhen Viatom Technology models including: 3614, 2ADXK-3614, 2ADXK3614, ER1-LW, ER1-LB Dynamic ECG Recorder, Dynamic ECG Recorder
Shenzhen Viatom Technology Co., Ltd. 3614 Dynamic ECG recorder 2ADXK-3614 2ADXK3614 3614
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DocumentDocument(MDoyndealm:EiRc1E-LCBGrEeRc1o-rLdWer) Contents 1. The basics.....................................................................................1 2. Introduction.................................................................................. 3 3. Using Instructions................................................................................6 4. Maintenance................................................................................... 9 5. Accessories.....................................................................................11 6. Specifications...................................................................................11 7. Electromagnetic compatibility...................................................... 11 II 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. This device is not intended to replace the medical diagnosis of a professional doctor. The measurement results of this device are for reference only and cannot be directly used as a basis for clinical treatment. We do not recommend the use of this device if you have a pacemaker or other implantable device in your body. Please follow the doctor's advice if necessary. This device cannot be used with a defibrillator. This device cannot be used during ct or nuclear magnetic resonance (MRI) procedures. This equipment must not be used in a flammable environment (eg oxygen-rich environment). This device is not intended for use by infants weighing less than 10 kg. Do not swim or submerge the device in the water.Do not immerse the device in water or other liquids. Do not use acetone or other volatile solutions to clean the device. 1 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. This equipment cannot be placed in the following environments: direct sunlight, high temperature, high humidity, close to water or fire sources, and high electromagnetic influence. Users should try to avoid sweating. The sweat will affect the contact between the electrodes and the skin, affecting the quality of the measurement. Users should inspect loosened electrodes, that can degrade performance or cause other problems Do not participate in violent or extensive physical activity in order to make appropriate measurements. The measurement results of this device cannot distinguish all diseases.If your body feels unwell, you should consult your doctor immediately, in addition to the measurement results of this device. Do not self-diagnose and take medication based on the measurements of this device without consulting your doctor.In particular, do not take new medications 2 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. 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 2Hthe time required. The patient is the expected user. Do not pile up the long tubing at the head of the bed,as it may wrap around the head or neck of the patient during sleep. Li batteries capacity will decrease after charge discharge for 300 times. The electrodes (Applied parts) should not contact other conductive parts including earth. The product should not be maintained while in use. 3 2. Introduction 2.1 Product Name:Dynamic ECG recorder Model: ER1-LBER1-LW. No. Model Enclosure Color 1 ER1-LW 2 ER1-LB 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. 4 2.2.1 Contraindications: The product is not intended for use in patients with cardiac pacemakers or other implantable devices. 2.3 About ER1-LBER1-LW Right sign When wearing, the side marked "R" should be on the right hand side of the wearer. Display screen The display displays the device's power, heart rate, charging status and other information. Power interface contacts Be used to connect charging cable. Electrode buckle For connecting chest strap, disposable electrocardiogram electrode or charging cable. 5 2.4 Symbols Symbol Significance Type BF-Applied Part Manufacturer Authorized representative in the European Community This product complies with the 0197 EU 2017/745 (MDR) CautionIncorrect use may cause personal injury and damages of goods. Refer to instruction manual. Protected against spraying water and IP22 against access to hazardous parts with a tool, per IEC 60529. Follow Instructions for Use. Non-ionizing radiation SN Serial number Indicate separate collection for electrical and electronic equipment (WEEE). 2.5 Product structure and composition This product is mainly composed of Dynamic ECG recorder main unit, charging cable,Chest strap (optional), and Disposable ECG electrode(optional). 6 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. 3.2 Open box to check Please check the box carefully before unpacking.If you find any damage, please contact the carrier or the company immediately If the package is complete, unpack the package in the correct way and carefully remove the device and other components from the box. Check the device for any mechanical damage and 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 7 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. 8 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 1ECG 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 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. 9 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. When using the Chest strap measurement method, if necessary, 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 Measuringstep 1After selecting a measurement method, the device detects tchhaatngtehsetoECthGe sgirgeneanl aisndafulatoshmawticitahllhyetaurtrnreatde)o,nth, ethdeeviscigensatal rltisght to measure. 2)The duration of a measurement is 5 minutes to 168 hours. If you want to end the measurement, please remove the Disposable ECG electrodes or unfasten the chest strap to remove the device. After 8 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. Steps for data export by Bluetooth: 1) Turn on the Bluetooth function of the mobile equipment to ensure that the Bluetooth function is turned on. 2) Pairing via Bluetooth, the mobile equipment will get data form the device. Precautions: The device can store up to 10 part measurement data and up to 168h 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. After entering the charging state, the indicator light will turn yellow and steady; when the charging is completed, the indicator light will turn green and steady. 11 Figure 4 Warnings and Cautionary Advices 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. 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 12 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. Doing so may cause the battery to leak, overheat, ignite or explode. If the battery leaks, keep your skin and eyes free from leaking liquids. If skin or eyes come into contact with leaking liquid, rinse your skin or eyes immediately and go to hospital 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. Do not use petrol, thinners or similar solvent. Warnings and Cautionary Advices Before using another patient, the device must be cleaned 13 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 Problem solving Problem Possible Cause The device cannot Perform normal acquisition 1. The battery is low 2. Equipment damage Recommended Action 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. 14 5. accessories Serial number 1 2 3 Accessory name Charging cable Chest Strap (optional) Disposable ECG electrodes (optional) Quantity 1 1 2 Warnings and Cautionary Advice 1Use only the accessories specified in this manual, and using other accessories may damage the device. 2Check if the disposable ECG electrode has expired before use. 3The disposable ECG electrode used with this device is user-purchased device, which must be a formal device with a medical device registration certificate 4Disposable ECG electrodes should not be attached to patients with traumatized or scarred skin. 5Disposable ECG electrodes should be in close contact with the skin. If itching or skin irritation or ulceration occurs, stop using it immediately. 15 6 Specifications Classification EC Directive Degree protection against electrical shock Environmental Item Temperature Relative humidity (noncondensing) Atmospheric pressure Degree of dust&water resistance Drop test Power supply Type of battery Battery specification MDR, EU 2017/745 R&TTE, 2014/53EU ROHS 2.0, 2011/65/EU Type BF Operating 5 ~ 45°C 10% ~ 95% 700 ~ 1060 hPa IP22 1.0 m Storage -25 ~ 60°C 10% ~ 95% 700 ~ 1060 hPa Rechargeable lithium polymer battery 3.8Vdc, 240mAh Battery run time 168 hours (full state) Charging input voltage range Charging time ECG Lead type Lead Input impendence Linearity and dynamic range 4.5 ~ 5.5v DC voltage 2 hours (to 90% power) single-use ECG electrode Lead I 10M, 10Hz 10mV (peak-to-valley) A-1 Common mode rejection Frequency response Gain error Physical Size Packing size weight Wireless connectivity EXPECTED SERVICE LIFE 60dB 0.67 ~ 40 Hz Maximum error ±10% 100×23×8.5 mm 172×113×59mm <20 g (with battery) Bluetooth connection support Built-in Bluetooth 4.0 BLE 5 year 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. 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. Note: This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference in a residential installation. This equipment generates uses and can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to radio communications. However, there is no guarantee that interference will not occur in a particular installation. If this equipment does cause harmful interference to radio or television reception, which can be A-2 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. The device can be used in portable exposure condition without restriction. A-3 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. · The use of accessories and power cord other than those specified, with the exception of cables sold by the manufacturer of the equipment or system as replacement parts for internal components, may result in increased emissions or decreased immunity of the equipment or system. Guidance and manufacturer's declaration electromagnetic emissions The model Dynamic ECG recorder is intended for use in the electromagnetic environment specified below. The customer or the user of the model Dynamic ECG recorder should assure that it is used in such an environment. Emissions test Compliance RF emissions CISPR 11 Group 1 RF emissions CISPR 11 Class B Harmonic emissions n.a. IEC 61000-3-2 Voltage fluctuations/ flicker emissions IEC 61000-3-3 Electromagnetic environment guidance The model Dynamic ECG recorder uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment. The model Dynamic ECG recorder is suitable for use in all establishments, including domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes. B-1 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 custome or the user of The model Dynamic ECG recorder can help preven 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 maximum output power of the communications equipment. Rated maximum output power of transmitter (W) Separation distance according to frequency of transmitter (m) 150kHz to 80MHz 3.5 d [ ] P V1 80MHz to 800MHz d [3.5] P E1 800MHz to 2.7GHz 7 d [ ] P E1 0.01 0.12 0.04 0.07 0.1 0.37 0.12 0.23 1 1.17 0.35 0.70 10 3.70 1.11 2.22 100 11.70 3.50 7.00 For transmitters rated at a maximum output power not listed above, the recommended separation distance d in metres (m) can be estimated using the equation applicable to the frequency of the transmitter, where p is the maximum output power rating of the transmitter in watts (W) according to thetransmitter manufacturer. NOTE 1 At 80 MHz and 800 MHz, the separation distance for the higher frequencyrange applies. NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. B-2 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. Freque ncy MHz Maxim um Power W Distan ce IEC 60601 Test Level Compl iance Level Electromagnetic Environment - Guidance RF wireless 385 1.8 0.3 27 27 communications equipment should be used no closer to 450 2 0.3 28 28 any part of the device, including cables, than the 710 recommended separation distance calculated from the 745 0.2 0.3 9 equation applicable to the 9 frequency of the transmitter. Recommended separation 780 810 distance 870 2 0.3 28 28 Where P is the maximum output power rating of the 930 ransmitter in watts (W) according to the transmitter 1720 manufacturer and d is the recommended separation distance in meters (m). 1845 2 0.3 28 28 Field strengths from fixed RF transmitter, as determined by an 1970 electromagnetic site survey, B-3 should be less than the 2450 2 0.3 28 28 compliance level in each 5240 frequency range. Interference may occur in 5500 0.2 0.3 9 the vicinity of equipment 9 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 Dynamic ECG recorder is intended for use in the electromagnetic environment specified below. The customer or the user of The mode Dynamic ECG recorder should assure that it is used in such an environment. Immunity test IEC 60601 test level Com p li ance level Electromagneticenvironment guidance Conducted RF IEC61000-4-6 Radiated RF IEC61000-4-3 3Vrms 150kHz to 80MHz 10V/m 80MHz to 2.7GHz Portable and mobile RF communications equipment should be used no closer to any part of The model Dynamic ECG recorder, including cables, than the recommended separation distance calculated from the equation applicable N/A to the frequency of the transmitter. Recommended separation distance 10V/m 80MHz to 800MHz 800MHz to 2.7GHz B-4 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. NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. a The ISM (industrial, scientific and medical) bands between 0,15 MHz and 80 MHz ar 6,765 MHz to 6,795 MHz; 13,553 MHz to 13,567 MHz; 26,957 MHz to 27,283 MHz; and 40,66 MHz to 40,70 MHz. The amateur radio bands between 0,15 MHz and 80 MHz are 1,8 MHz to 2,0 MHz, 3,5 MHz to 4,0 MHz, 5,3 MHz to 5,4 MHz, 7 MHz to 7,3 MHz, 10,1 MHz to 10,15 MHz, 14 MHz to 14,2 MHz, 18,07 MHz to 18,17 MHz, 21,0 MHz to 21,4 MHz, 24,89 MHz to 24,99 MHz, 28,0 MHz to 29,7 MHz and 50,0 MHz to 54,0 MHz. b The compliance levels in the ISM frequency bands between 150 kHz and 80 MHz and in the frequency range 80 MHz to 2,7 GHz are intended to decrease the likelihood tha mobile/portable communications equipment could cause interference if it i inadvertently brought into patient areas. For this reason, an additional factor of 10/3 ha been incorporated into the formulae used in calculating the recommended separation distance for transmitters in these frequency ranges. c Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To asses the electromagnetic environment due to fixed RF transmitters, an electromagnetic sit survey should be considered. If the measured field strength in the location in whichTh model Dynamic ECG recorder is used exceeds the applicable RF compliance level above, B-5 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. The customer or the user o The model Dynamic ECG recorder should assure that it is used in such a n environment. Immunity test IEC 60601 test Compliance Electromagnetic level level environment guidance Electrostatic discharge (ESD) IEC 61000-4-2 ± 8 kV contact ± 2 kV± 4 kV± 8 kV± 15kV air Floors should be wood, ± 8 kV contact concrete or ceramic tile. If ± 2 kV± 4 kV floors are covered with ± 8 kV± 15kV synthetic material, the air relative humidity should be at least 30%. Electrical fast transient/ burst IEC 61000-4-4 ± 2 kV for power supply lines ± 1 kV for input/ output lines n.a. n.a. Surge IEC61000-4-5 ± 1 kV line to line ±2 kV line to earth n.a. n.a. 0% UT 0,5cycle Voltage dips, short interruptions and voltage variations At 0°,45°,90°,135°,18 0°,225°,270°and 315°, n.a. n.a. on power supply input lines IEC 61000-4-11 0% UT 1cycle and 70% UT 25/30 cycles Single phase:at 0° Power frequency (50/60 Hz) magnetic field IEC 61000-4-8 30A/m, 50/60Hz 30A/m,50/60H z Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment. NOTE : UT is the AC mains voltage prior to application of the test level. B-6 ER1-LWER1-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 PN255-01918-00 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-LBER1-LW Revision date: April 2021