IMEDIPLUS MCE12L001A1 User Manual
Ca
RDIaRT
Wireless 12-Lead Electrocardiograph Monitor
User’s Manual
(Draft)
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Model no.: MCE12L001
20190320 Ver. 2.0
Be sure to read the original manual and follow the instructions before use.
Content
Warning and Precaution ................................................................................................... 2
Chapter 1 Outline .............................................................................................................. 4
Chapter 2 Composition ..................................................................................................... 5
Chapter 3 ECG electrode Hookup ..................................................................................... 9
Chapter 4 Connecting setting ......................................................................................... 12
Chapter 5 CaRDIaRT ECG APP Introduction .................................................................... 13
Chapter 6 Environment and Maintenance ...................................................................... 17
Chapter 7 Product Specification ..................................................................................... 20
Chapter 8 After-sales service and Warranty period ........................................................ 22
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Chapter 9 Symbol Description and Manufacturer Information ...................................... 23
Chapter 10 FCC Compliance Statement .......................................................................... 24
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Warning and Precaution
Warning and Precaution
Warning and PrecautionWarning and Precaution
Warning
1) It is not intended as a sole means of diagnosis.
2) Please remove the battery when not using for a long time, to avoid corrosion of the
spring if the battery holder.
3) Do not use the product near any flammable gas (e.g., high concentrations oxygen,
hydrogen or anesthetics), which can cause an explosion or fire.
4) To avoid electric shock, do not disassemble or modify the product of one’s own.
5) This product is a portable device, but the safety of the instrument is not able to be
ensured in the transport process with a strong impact or fall.
6) Avoid the product from water, or the patient and the operator may involve in
electric shock and other dangers.
7) To avoid infection, please follow the instruction below;
※ Regularly clean the parts that contact with patients.
※ Patients of open type infectious disease do not use the product for testing.
8) When placing the wires or cables, be aware to avoid the possibility of tripping
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people or winding the patient's neck.
9) To ensure using the equipment safely, follow the maintenance procedures
contained in the original manual.
10) Improper battery disposal may result in explosion or contamination. Please
recycle the battery in accordance with local regulations, do not throw the battery
as common trash.
11) Do not use the product with Pacemaker.
12) Materials meet the biocompatibility requirements that comes in contact with the
patient’s body.
13) The product is classified as CF type equipment; the product can be directly
applied to the heart by using this product to be in contact with the patient to
perform functions. Don not touch conductive parts and conductive parts of the
system on the outside, including grounding wires.
14) Please use a defibrillation-proof wire to prevent burns which caused by the
defibrillator discharge.
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15) Limb lead and chest lead that do not recommend for use in newborns and child
Precaution
1) The conductor parts of the electrode of ECG signal record box and its connector
(including the neutral electrode) should not contact with other conductor parts,
including the earth.
2) The factory will yearly check whether the ECG signal record box and the cable are
damaged.
3) Do not use the product with high frequency surgical equipment.
4) The product is classified as CF type equipment; it is an anti-defibrillation device
5) Do not use accessories that are not included in the product system. The use of
non-original accessories may result in inaccurate patient data, damage to
equipment, and invalid warranty.
6) Do not use accessories that are not included in the product system. The use of
non-original accessories may result in inaccurate patient data, damage to
equipment, and invalid warranty.
7) The electrodes is suggested to be placed by professional medical personnel.
8) To avoid the possible damage, do not contact the product with sharp or hard
objects.
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9) Do not expose the patient cable to strong ultraviolet radiation.
10) Do not stretch the patient cable for this may cause mechanical or electrical
malfunction. Before storing the patient cable should be wrapped as a loose circle.
11) Avoid placing the patient cable where it may be caught, stretched, or stamped.
Otherwise the results may be inaccurate and may require repair.
12) The surface of disposal electrodes should be checked if lint or dust is on the
surface before use to avoid collecting poor patient data.
13) The product is protected against water and dust( IP33 classification, it’s
protected against solid objects of 2.5mm diameter and greater and spraying
water 60 degrees from vertical)
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Chapter 1 Outline
Chapter 1 Outline
Chapter 1 OutlineChapter 1 Outline
1.1 Product Introduction
CaRDIaRT Wireless 12-Lead Electrocardiograph Monitor (Model no. MCE12L001) is
a compact, lightweight, easy carry, and agile product. The data is transmitted
through bluetooth, avoided the inconvenience of the traditional data transmission;
also making transmission space and distance more flexible, convenient and
smooth.The software can be installed on iOS devices, users can view data on iPad /
iPhone / iTouch; this kind of working mode is more flexible than the traditional
system composed of personal, laptop, the record box (with data lines), and the
printer (with data transmission cable).
1.2 Intended Use
It is mainly used for 12 leads on the front and horizontal planes. It records the
electrical and physiological activities of the heart in twelve different directions. The
depolarization waveform is observed from twelve different angles and transmitted
to the software application via bluetooth. An electrocardiogram was generated,
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and changes in myocardial damage were observed with an electrocardiogram.
This product cannot be used as the sole means for disease diagnosis.
1.3 Principle
The product collect the ECG signal through limb and chest limbs, initially amplifies
the signal through preamplifier, and filter out the polarization voltage, baseline
shift, and high frequency noise. Amplify the signal with the use of secondary
amplification circuit, and convert the analog signal to digital signal with the A / D
converter. Then transmit the signal to iOS mobile system through Bluetooth, at the
same time, display on the screen for clinicians to diagnose and study.
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1.4 Features
Compact, lightweight and easy carry
Bluetooth low energy
Personalization report for storage and delivery
Cloud ECG Transmission System
Real-time data transmission, shortening ECG interpretation time
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Chapter
Chapter 2222 Composition
ChapterChapter
Composition
CompositionComposition
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The product is composed of ECG acquisition recorder, ECG patient cable,
ECG patient cable
limb leads/ chest leads and instruction manual.
2.1 Appearance
Power button
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● Power indicator :
Green light indicates power on;
(1) Flashing green every 5 seconds indicates the battery power is
10%-19%, it is recommended to replace the battery;
(2) Flashing green every 1 second, please replace the battery
immediately (the battery power is 0%-9%)
● Bluetooth repairing:
When Bluetooth pairing or data transmission has been completed,
green light on and flashing blue light.
Patient cable connector
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Battery cover
Battery compartment
Meter label
Caution: If there’s any damage between the connection of the patient cable
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2 x AA 電池
connector and ECG acquisition recorder, please replace with the specified
lead wire.
ECG Acquisition Recorder (Back)
Chest leads
Limb leads
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