Viatom ER1 User Manual Download

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A-1

Specifications

Classification

EC Directive

MDD, 93/42/EEC
R&TTE, 2014/53EU
ROHS 2.0, 2011/65/EU

Degree protection against

electrical shock

Type

Environmental

Item

Operating

Storage

Temperature

5 ~ 45

-25 ~ 60

Relative humidity

(non-condensing)

10% ~ 95%

Atmospheric pressure

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

80 hours (full state)

Charging input voltage

range

4.5 ~ 5.5v DC voltage

Charging time

2 hours (to 90% power)

ECG

Lead type

single-use ECG electrode

Lead

Lead I

Input impendence

≥

10M

, 10Hz

Linearity and dynamic

range

10mV (peak-to-valley)

Common mode rejection

≥

60dB

Frequency response

0.67 ~ 40 Hz

Summary of Contents for ER1

Page 1: ...hor Review Approval ViATOM TECHNOLOGY UNPUBLISHED ALL RIGHTS RESERVED This material is the proprietary information of ViATOM Technology And any use reproduction or distribution of the material contained herein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 ER1 Dynamic 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: ... 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 proce...

Page 4: ...ld 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 disea...

Page 5: ...and maximum storage temperature from the product to ready for use is 2H the 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 ea...

Page 6: ... About ER1 1 Right sign When wearing the side marked R should be on the right hand side of the wearer 2 LED indicator Green light flashes with the rhythm of the heartbeat the device is in the normal collection state Green light flashes 5s intervals the device is in standby mode Yellow light is always on the device is charging and the green light is always on when it is full Yellow light Flash insu...

Page 7: ...uropean 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 radiation SN Serial number Indicate separate colle...

Page 8: ...re 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 car...

Page 9: ...ure 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 methods 1 ECG electrode wearing method Remove the packaging of the single use ECG electrode install the ECG electrode ...

Page 10: ... 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 Pleas...

Page 11: ... measurement will be ended and the data will be saved 3 5 Data view 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 Use OTG adapter and charging cable by pairing on the...

Page 12: ...teps 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 Figure 5 Warnings and Cautionary Advices The device cannot be used du...

Page 13: ...attery power is low the indicator light will turn yellow and flash and the device needs to be charged Warnings and Cautionary Advices 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 Overheat ing of the batter...

Page 14: ...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 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 dis...

Page 15: ...lectrode according to the method described in the manual 5 accessories Serial number Accessory name Quantity 1 Charging cable 1 2 OTG adapter 1 3 Chest Strap optional 1 4 Disposable ECG electrodes optional 2 Warnings and Cautionary Advices 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...

Page 16: ...lectrodes 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: ...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 80 hours full state Charging input voltage range 4 5 5 5v DC voltage Charging time 2 hours to 90 power ECG Lead type single use ECG electrode Lead Lead I Input impendence 10MΩ 10Hz Linearity and dynamic ...

Page 18: ...ncluding 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 install...

Page 19: ... 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 ...

Page 20: ...c 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 Electromagnetic environment guidance RF emissions CISPR 11 Group 1 The model Dynamic ECG recorder uses RF energy only for its internal function Ther...

Page 21: ...nsmitter W Separation distance 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 ...

Page 22: ...n ce IEC 60601 Test Level Compl iance Level Electromagnetic Environment 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 t...

Page 23: ...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 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 equi...

Page 24: ...Hz 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 that mobile portable communications equipment could cause inter...

Page 25: ...D IEC 61000 4 2 8 kV contact 2 kV 4 kV 8 kV 15kV air 8 kV contact 2 kV 4 kV 8 kV 15kV air Floors should be 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...

Page 26: ...ngdong China www 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 ER1 Revision date April 2020 ER2 Dynamic ECG recorder 0197 ...

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