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I

Version

Date

Description

Author

User's Manual(ECG

recorder)

Shenzhen Viatom Technology

Co., Ltd.

Document Number

Reversion

42-DO-00281

A

Author

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(UNPUBLISHED)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.

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Summary of Contents for 3622

Page 1: ...Review Approval ViATOM TECHNOLOGY UNPUBLISHED ALL RIGHTS RESERVED This material is the proprietary information of ViATOM Technology And any use reproduction or distribution of the material contained herein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: ...II ER2 ECG recorder 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 User s Manual ...

Page 3: ...e 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 u...

Page 4: ...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 resul...

Page 5: ... 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 2 Introduction 2 1 Intended Use The product is intended to measure review and store adults ECG data at h...

Page 6: ...n and flash According to patient heart rate rhythm The device is working normally Green and flash 5 seconds apart measurement completed and the device is in normal standby mode or when the battery is fully charged Yellow the device is charging and it is off after being fully charged Yellow and flash 5 seconds apart the battery is low Standby mode Blue The device is in Bluetooth connection and the ...

Page 7: ...rt Manufacturer 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 IP22 Protected against spraying water and against access to hazardous parts with a tool per IEC 60529 Follow Instructions for Use Non ionizing ...

Page 8: ...ta 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 th...

Page 9: ...rage 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 The device should be charged to activate the device before it is used for the first time 3 4 Measuring process 3 4 1 Measurement meth...

Page 10: ...ordium 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 When using finger measurement make sure that your left and right hands are not in contact otherwise the measurement results will be affected d When using the strap measureme...

Page 11: ...continuous contact exceed 15 minutes the device measurement time is up the device automatically turns off and the signal light changes to Green and flash 5 seconds apart The device will complete a 15 minute data save 3 5 Data view After the measurement is completed the data measured in the devicd can be transmitted to the mobile equipment for viewing by Bluetooth Steps for data export by Bluetooth...

Page 12: ...able 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 go out 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 o...

Page 13: ...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 Overheat ing 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 ...

Page 14: ...gulations 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 Recommended Action 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 m...

Page 15: ...ial number Accessory name Quantity 1 Charging base 1 2 Charging cable 1 3 Strap optional 1 Warnings and Cautionary Advices Use only the accessories specified in this manual and using other accessories may damage the device ...

Page 16: ...lative humidity non condensing 10 95 10 95 Atmospheric pressure 700 1060 hPa 700 1060 hPa Degree of dust water resistance IP22 Drop test 1 0 m Power supply Type of battery Rechargeable lithium polymer battery Battery specification 3 7Vdc 90mAh Battery run time 48 hours full state Charging input voltage range 4 5 5 5v DC voltage Charging time 2 hours to 90 power ECG Lead type Integrated ECG electro...

Page 17: ...y Wireless connectivity Bluetooth connection support Built in Bluetooth 4 0 BLE Expected service life 5 year Bluetooth RF Frequency range 2 402 2 480 GHz GFSK Modulation Wireless Quality of Service QoS Transmission Distance 1 5m Transmission Time 10s for one ECG record Data integrity 100 Network topology Point to Point Band width 1Mbps Expected service life 5 years ...

Page 18: ... 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 Emissions test Compliance Electromagnetic environment guidance RF emissions CISPR 11 Group 1 The model ECG recorder uses RF energy only for its internal function Therefore its RF emissions are very low and are not likely to cau...

Page 19: ...ance according to frequency of transmitter m 150kHz to 80MHz P V d 5 3 1 80MHz to 800MHz P E d 5 3 1 800MHz to 2 7GHz P E d 7 1 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 frequenc...

Page 20: ...Guidance 385 1 8 0 3 27 27 RF wireless communications equipment should be used no closer to any part of the device including cables than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter Recommended separation distance Where P is the maximum output power rating of the ransmitter in watts W according to the transmitter manufacturer and d...

Page 21: ...r the user of The model ECG recorder should assure that it is used in such an environment Immunity test IEC 60601 test level Compli ance level Electromagnetic environment guidance Conducted RF IEC61000 4 6 Radiated RF IEC61000 4 3 3Vrms 150kHz to 80MHz 10V m 80MHz to 2 7GHz N A 10V m Portable and mobile RF communications equipment should be used no closer to any part of The model ECG recorder incl...

Page 22: ...9 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 that mobile portable communications equipment could cause interference if it is inadvertently brought into patient areas For this reason an additional factor of 10 3 has been incorporat...

Page 23: ... wood concrete or ceramic tile If floors are covered with synthetic material the 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 Voltage dips short interruptions and voltage variations on power supply input lines IEC 61000 4 11 0 UT 0...

Page 24: ...viatomtech com MedNet GmbH Borkstrasse 10 48163 Muenster Germany TEL 49 251 32266 0 FAX 49 251 32266 22 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 ER2 Revision date July 2019 ER2 ECG recorder 0197 ...

Page 25: ...es 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 determined by turning the equipment off and on th...

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