Shenzhen Viatom Technology ER2 ECG Recorder User Manual

Shenzhen Viatom Technology ER2 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 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.

• 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 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 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 earth

2. Introduction

2.1 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.

2.1.1 Contraindications:

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

2.2 About ER2

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

2. LED indicator
   Off: The device is not activation or battery is run out,
   Green : the lead is off;
   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, 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 device is in normal standby mode; Blue and flash(According to patient heart rate rhythm): The device is working normally and The device is in Bluetooth connection.

3. Charging interface Used to connect the charging cable.

4. Charging base For the product to charge.

2.3 Symbols

2.4 Product structure and composition

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

2.5 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 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 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. 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:
a. Shake your hands at will
b. Loose fingers during measurement

2. Strap measurement method: Attach the main unit to the strap and then wear the strap with the main unit attached to the precordium (the indicator light is facing up) as shown below.

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 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 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 sound.
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 save.
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 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. By pairing on the mobile equipment , after the pairing is successful, the indicator light will turn into a steady blue light.
3. According to the prompts of the mobile equipment, data export is implemented.

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 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 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 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 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 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 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

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

5. accessories

Warnings and Cautionary Advices

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

6. Specifications

7. 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.
• 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.

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.

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.

Recommended separation distances between RF wireless communications equipment

ER2 ECG recorder

Shenzhen Viatom Technology Co., Ltd
4E, 3#, Tingwei Industrial Park, Honglang North 2nd Road, Baoan District, Shenzhen, China
www.viatomtech.com

[EC|REP] MedNet GmbH
Borkstrasse 10 · 48163 Muenster · Germany TEL: +49 251 32266-0 FAX: +49 251 32266-22

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: ER2 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.

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