Shenzhen Viatom Technology ER1-LB Dynamic ECG Recorder User Manual
- June 6, 2024
- Shenzhen Viatom Technology
Table of Contents
Shenzhen Viatom Technology ER1-LB Dynamic ECG Recorder
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.
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.
- The product should not be maintained while in use.
Introduction
Product
Name: Dynamic ECG recorder
Model: ER1-LB, ER1-LW.
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
Contraindications:
The product is not intended for use in patients with cardiac pacemakers or
other implantable devices.
About ER1-LB, ER1-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.
Symbols
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).
Using Instructions
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.
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.
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.
Measuring process
Measurement Methods
ECG 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.
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
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.
Measuring step
- After selecting a measurement method, the device detects changes to the green and flash (with heart rate)
- 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 1 minute, the device completes data storage.
- 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.
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:
- Turn on the Bluetooth function of the mobile equipment to ensure that the Bluetooth function is turned on.
- 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.
Charging
This device uses a rechargeable lithium battery charged by connecting a laptop or a power adapter with charging cable. Charging specific steps:
- Place the main connect the charging base through the charging cable.As shown below.
- 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.
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.
Maintenance
Warnings and Cautionary Advices
Have the device repaired by authorized service centers only, otherwise its
warranty is invalid
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.
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 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.
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 with 70% medical
alcohol or water. At the same time, disposable ECG stickers cannot be mixed
and must be replaced.
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.
Problem solving
Problem| Possible Cause| Recommended
Action
---|---|---
The device
cannot
| 1. The battery is
low
| 1. Please charge the
device
Perform normal acquisition| 2. Equipment damage| 2. Please contact your
local agent
ECG waveform is disordered,| 1. Measurement
method is
| 1. Please
re-measure
and the clutter is large| incorrect
2. Poor contact of ECG electrode
| according to the recommendations of
the manual
| | 2. Please clean the
ECG electrode
| | according to the method described in the manual.
accessories
Serial number | Accessory name | Quantity |
---|---|---|
1 | Charging cable | 1 |
2 | Chest Strap (optional) | 1 |
3 | Disposable ECG electrodes (optional) | 2 |
Warnings and Cautionary Advice
- Use only the accessories specified in this manual, and using other accessories may damage the device.
- Check if the disposable ECG electrode has expired before use.
- The disposable ECG electrode used with this device is user-purchased device, which must be a formal device with a medical device registration certificate
- Disposable ECG electrodes should not be attached to patients with traumatized or scarred skin.
- Disposable ECG electrodes should be in close contact with the skin. If itching or skin irritation or ulceration occurs, stop using it immediately.
Specifications
Classification
EC Directive
| MDR, EU 2017/745
R&TTE, 2014/53EU
ROHS 2.0, 2011/65/EU
Degree protection against electrical shock| Type BF
Environmental
Item| Operating| Storage
Temperature| 5 ~ 45°C| -25 ~ 60 ° 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| 3.8Vdc, 240mAh
Battery run time| 168 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 range| 10mV (peak-to-valley)
Common mode rejection| ≥60dB
---|---
Frequency response| 0.67 ~ 40 Hz
Gain error| Maximum error ±10%
Physical
Size| 100×23×8.5 mm
Packing size| 172×113×59mm
weight| <20 g (with battery)
Wireless connectivity| Bluetooth connection support Built-in Bluetooth
4.0 BLE
E XPECTED SERVICE LIFE| 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 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.
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.
Guidance and manufacturer ’ s declaration
– electromagnetic emissions
The model Dynamic ECG recorder is intended for use in the electromagneti
environment specified below. The customer or the user of the model Dynami 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. 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 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.
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 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
V 1
| 80MHz to 800MHz
d = [ 3.5 ] P
E
| 800MHz to 2.7GHz
7
d = [ ] 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 thetransmittermanufacturer.
NOTE 1 At 80 MHz and 800 MHz, the separation distance for the higher frequencyrangeapplies.
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 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
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.
Recommendedseparation
distance
Where P is the maximum output power rating of the ransmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in meters (m).
Field strengths from fixed RF transmitter, as determined by an electromagnetic site survey,
450
|
2
|
0.3
|
28
|
28
710
|
0.2
|
0.3
|
9
|
9
745
780
810
|
2
|
0.3
|
28
|
28
870
930
1720
|
2
|
0.3
|
28
|
28
1845
1970
2450
|
2
|
0.3
|
28
|
28
| should be less than the compliance level in each|
---|---|---|---|---|---|---
frequency range.|
5240| | | | |
| | | | Interference may occur in|
| | | | the vicinity of equipment|
5500|
0.2| 0.3| 9| 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 electromagneti environment specified below. The customer or the user of The mod Dynamic ECG recorder should assure that it is used in such an environment.
Immunitytest
| IEC 60601
test level
| Compli ance level| Electromagneticenvironment– guidance
| | | Portable and mobile RF communications
| | | equipment should be used no closer to
| | | any part of The model Dynamic ECG
| | | recorder, including cables, than the
Conducted RF IEC61000-4-6
Radiated RF IEC61000-4-3
| 3Vrms 150kHz to 80MHz
10V/m 80MHz to 2.7GHz
|
N/A
10V/m
| recommended separation distance calculated from the equation applicable to the frequency of the transmitter.
Recommendedseparation distance
| | | 80MHz to 800MHz
| | | 800MHz to 2.7GHz
| | | 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 radi (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,
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
environment.
Immunitytest| 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.
Voltage dips, short interruptions and voltage variations on power supply input lines
IEC 61000-4-11
| 0% UT 0,5cycle At
0°,45°,90°,135°,18
0°,225°,270°and
315°,
0% UT 1cycle
and 70% UT 25/30 cycles
Single phase:at 0°
|
n.a.
|
n.a.
Powerfrequency (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, Building3, Tingwei Industrial Park,NO.6 Liufang Road,Block 67 Xin’an Street,Baoan District Shenzhen 518101 Guangdong China www.viatomtech.com
Documents / Resources
|
Shenzhen Viatom Technology ER1-LB Dynamic ECG
Recorder
[pdf] User Manual
3614, 2ADXK-3614, 2ADXK3614, ER1-LW, ER1-LB Dynamic ECG Recorder, Dynamic ECG
Recorder
---|---
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