viatom 3624 ECG Recorder User Manual

viatom 3624 ECG Recorder User Manual

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

• This device is not intended to replace the medical diagnosis of a professional

• The measurement results of this device are for reference only and cannot be directly used as a basis for clinical

• We do not recommend the use of this device if you have a pacemaker or other implantable device in your Please follow the doctor’s advice if necessary.

• This device cannot be used with a

• 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 Do not immerse the device in water or other liquids.

• Do not use acetone or other volatile solutions to clean the device.

• Do not strongly collide or crush the If the casing is broken, stop using it.

• This device cannot be placed in a pressure vessel or gas sterilization

• Do not disassemble the device at will, otherwise it may cause machine malfunction or affect the normal operation of the

• Keep this device out of the reach of children or pets、

• This device should not be used on people with sensitive skin or

• This equipment cannot be placed in the following environments: direct sunlight, high temperature, high humidity, close to water or fire sources, and high electromagnetic

• 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

• 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

• Do not self-diagnose and take medication based on the measurements of this device without consulting your In particular, do not take new medications 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 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

• When the ambient temperature is 20 ℃, the minimum and maximum storage temperature from the product to ready for use is 2H（the time required）.

• The patient is the expected

• 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

• 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

2.1Name and Model

Product Name: ECG recorder
Product Model: ER2-SC

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 an auto-analysis function.

2.2.1 Contraindications:

The product is not intended for use in patients with cardiac pacemakers or other implantable devices.

2.3 About ECG recorder

1. Display screen
   It can display time, power, waveform and heart rate when measuring.

2. Logo on the right
   When measuring, the R mark is located on the right side of the user.

3. LED indicator
   Off: The device is not activation or battery is run out. Green: When the battery is fully charged.
   Green 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.
   Yellow: The device is charging, the yellow light turns off and the green light turns on when fully charged.
   Yellow and flash(5 seconds apart): the battery is low(Standby mode).
   Blue : The device is in Bluetooth connection.

4. ECG electrode
   It is used to connect the body surface and receive the human body ECG signal.

5. Charging interface
   Used to connect the charging cable.

6. Charging base
   For the product to charge.

2.4 Symbols

**** 2.5 Product structure and composition

This product is mainly composed of ECG recorder main unit, charging base, charging cable and strap (optional).

2.6 Software information

Software name: ECG recorder software Release version：V1.0

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
• This device has no alarm function and therefore does not generate an audible alarm for the result of the
• 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
• 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
• The device may be contaminated by microorganisms during storage, transportation and 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

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. Finger measurement method: Directly touch the ECG electrode with the thumb of both hands (R on the silk screen indicates the right hand side, and L indicates the left hand side), as shown in the following figure:

Wrong way of operation:

1. Shake your hands at will
2. Loose fingers during measurement

3.4.2 Measuring step

1. After selecting a measurement method, the device detects that the ECG signal is automatically turned on, the signal light changes to the green and flash , the device starts to measure, and the device will emit a “drop” heartbeat
2. When the measurement is over 30 seconds, the device will emit a short beep, at which point the measurement can be ended and the device will complete a 30 second-15 minutes data
3. When the patient 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 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
2. Pairing via Bluetooth, the mobile equipment will get data form the

Precautions:
The device can store up to 10 part measurement data and up to 20 minutes 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 unit on the charging base and connect the charging base through the charging cable. As shown
2. Connect the charging cable to the usb port with 5v output voltage for After entering the charging state, the indicator light will turn yellow and steady; when the charging is completed, the indicator light will go out.

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
• When the long-term storage is not in use, it is necessary to periodically charge the device to maintain battery

4. Maintenance

Warnings and Cautionary Advices Have the device repaired by authorized service centres 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

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 Advices

• The built-in rechargeable lithium-ion battery cannot be 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 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
• If the battery leaks, keep your skin and eyes free from leaking 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 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 To dispose of the battery, follow local laws for proper disposal.

4.3 Cleaning

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 medical alcohol or water.

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| 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 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. accessories

Warnings and Cautionary Advices

• Use only the accessories specified in this manual, and using other accessories may damage the device.

7. Specifications

Classification

EC Directive

| EU 2017/745 (MDR)
RED, 2014/53/EU
ROHS 2.0, 2011/65/EU
Degree protection against electrical shock| Type CF
Environmental
Item| Operating| Storage
Temperature| 5 ~ 45°C| -25 ~ 70°C
Relative 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

| 5v DC voltage
Charging time| 2 hours (to 90% power)
ECG
Lead type| Integrated ECG electrodes
Lead| Lead I
Input impendence| ≥10MΩ, 10Hz
Linearity and dynamic

range

| 10mV (peak-to-valley)
Common mode rejection| ≥60dB
Frequency response| 0.67 ~ 40 Hz
Gain error| Maximum error ±10%
---|---
Physical
Size| 92×32×8.2 mm
Packing size| 172×113×59mm
weight| <50 g (with battery)
Wireless connectivity| Bluetooth connection support Built-in Bluetooth 4.0 BLE
E XPECTED SERVICE LIFE| 5 year

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
• 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

Guidance and manufacturer ’ s declaration – electromagnetic emissions

The model ECG recorder is 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 cause any interference in nearby electronic equipment.
RF emissions CISPR 11| Class B| The model 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.
Harmonic emissions

IEC 61000-3-2

| n.a.
Voltage fluctuations/ flicker emissions IEC 61000-3-3
Recommended separation distances between portable and

mobile RF communications equipment and the A &D unit

The model 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 ECG recorder can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and The model 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

d = [3.5] P ____V 1

| 80MHz to 800MHz

d = [3.5] P E 1

| 800MHz to 2.7GHz

d = [ 7 ] P E 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 frequency of the transmitter, where p is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer.

NOTE 1 At 80 MHz and 800 MHz, the separation distance for 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.

model ECG recorder should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, succahs re- orienting or relocating The model ECG recorder d Over the frequency range 150 kHz to 80 MHz, field strengths should belles than3V/m.

Guidance and manufacturer’s declaration – electromagnetic immunity

The model ECG recorder is 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.
Immunity test| IEC 60601 test level| Compliance level| Electromagnetic environment – guidance

Electrostatic discharge (ESD) 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.
 | 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.

Shenzhen Viatom Technology Co., Ltd
4E, Building 3, Tingwei Industrial Park No. 6 Liufang Road, Block 67 Xin’an Street, Baoan District Shenzhen 518101 Guangdong China

www.viatomtech.com

(EC| REP) MedNet EC-REP GmbH
Borkstrasse 10 · 48163 Muenster · Germany

**** 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-SC
Revision date: July 2019

FCC Warning:
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 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.

References

• Home Wearable Medical Devices: Pulse Oximeter Manufacturer | Viatom

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