Lepu Medical LeECG Series User manual

LeECG & NeoECG Series
Electrocardiograph
Operator’s Manual

I
IPreface
Declaration
Shenzhen Carewell Electronics Co., Ltd. (hereinafter referred to as
"Carewell") makes no warranties of any kind, including (but not
limited to) implied warranties of merchantability and fitness for a
particular purpose. Carewell assumes no responsibility for any errors
that may appear in this document, or for incidental or consequential
damage in connection with the furnishing, performance or use of this
material.
Carewell will make continuous improvement in features and
functions for future publication of new equipment without prior notice.
Copyright
This manual contains proprietary information protected by copyright
law. All rights reserved. Without the prior written consent of Carewell,
no part of this manual shall be copied or reproduced in any form or
by any means.
© 2021 Shenzhen Carewell Electronics Co. Ltd. All rights reserved.
Revision
P/N: SZ09.24300554-03
Release Date: October 2021
Revision: V1.2
General Notes
 Italic text is used to indicate prompt information or quote the

II
referenced chapters or sections.
[XX] is used to indicate the character string in the software.
→ is used to indicate operational procedures.
All illustrations in this manual serve as examples only and may
differ from what is actually seen.
Special Notes
The warnings, cautions and tips in this manual are used to remind
readers of some specific information.
Warning
Indicates a potential hazard or unsafe practice, which, if not avoided, could
result in death or serious injury.
Caution
Indicates a potential hazard or unsafe practice, which, if not avoided, could
result in the loss or destruction of property.
Note
Provides important tips regarding the operation or function of the device.

III
II Manufacturer's Liability and Warranty
Manufacturer's Liability
Carewell is responsible for the safety, reliability and performance of
the device, only if:
Assembly operations, expansions, re-adjustments,
improvements and repairs of this device are performed by
personnel authorized by Carewell;
The electrical installation of the relevant room complies with the
applicable national and local requirements;
The device is used in accordance with the instructions in this
manual.
Carewell shall not be responsible for direct, indirect or ultimate
damage or delay caused by:
the device is disassembled, stretched and re-adjusted;
maintenance or modification of the device is conducted by
unauthorized personnel;
subsequent damage caused by improper use or maintenance;
replacement or removal of serial number label and manufacture
label.
mis-operation caused by the neglect to the instructions in this
manual.

IV
Warranty
The warranty period is subject to the terms in the sales contract.
The warranty covers all device failures caused by material, firmware
or production process. Any faulty parts can be repaired and replaced
free of charge during the warranty period.
Manufacturing Process and Raw Materials
Carewell warrants that there is no defect in raw material and
manufacturing process. During warranty period, Carewell will repair
or replace the defective part(s) free of charge if the defect has been
confirmed as raw material or manufacturing process defect under
normal operation and maintenance conditions.
Software or Firmware
Software or firmware installed in the products of Carewell will be
repaired by replacing the software or devices upon receipt of reports
proving that the software or firmware are defective, but Carewell
cannot guarantee that the use of the software or devices will not be
interrupted or error free.
Circuit Diagram
Upon request, Carewell may provide necessary circuit diagrams,
component part lists, and other technical information to assist
qualified service personnel in parts repair.
Note: Freight and other charges are excluded in the above warranty.
This device contains no user serviceable parts. All repairs should be

V
carried out by Carewell service personnel or its authorized
distributors. Otherwise, Carewell will not be responsible for the
safety, reliability and performance of the device.
Date of Manufacture and Service Life
The service life of the device is 10 years. Please refer to the label on
the back of the main unit for the date of manufacture.
Service Contact
Shenzhen Carewell Electronics Co., Ltd. Customer Service Center
Tel: [phone]
Fax: [phone]
Email: [e-mail]
Address: Floor 4, BLD 9, Baiwangxin High-Tech Industrial Park,
Songbai Road, Xili Street, Nanshan District 518108, Shenzhen, P.R.
China
Zip code: 518108
EC-Representative
Lepu Medical (Europe) Coöperatief U.A.
Abe Lenstra Boulevard 36, 8448 JB, Heerenveen, The Netherlands
Tel: [phone]
Fax: [phone]

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VII
Table of Contents
Chapter 1 Safety Guidance ................................................................. 1-1
1.1 Safety Warnings .................................................................... 1-1
1.1.1 Device Warnings......................................................... 1-1
1.1.2 Defibrillator and Pacemaker Warnings ....................... 1-5
1.1.3 Battery Warnings ........................................................ 1-6
1.2 Cautions................................................................................. 1-8
1.2.1 General Cautions........................................................ 1-8
1.2.2 Cleaning & Disinfection Cautions ............................. 1-10
1.3 Device Symbols ................................................................... 1-11
Chapter 2 Product Introduction............................................................ 2-1
2.1 Intended Use ......................................................................... 2-1
2.2 Contraindication..................................................................... 2-1
2.3 Structure and Composition .................................................... 2-2
2.4 Model Difference.................................................................... 2-3
2.5 Product View.......................................................................... 2-4
2.5.1 7”Device...................................................................... 2-4
2.5.2 10.1”Device................................................................. 2-8
2.5.3 Recorder Base .......................................................... 2-12
2.6 Function Features................................................................ 2-16
2.7 Operating Modes ................................................................. 2-17
2.7.1 Routine Use .............................................................. 2-17
2.7.2 Emergency Use ........................................................ 2-18
2.7.3 Standby Mode........................................................... 2-18
2.7.4 Demo Mode .............................................................. 2-19
Chapter 3 Operation Preparations....................................................... 3-1

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3.1 Unpacking and Checking....................................................... 3-1
3.2 Selecting an Installation Location .......................................... 3-1
3.3 Preparing the Device ............................................................. 3-2
3.3.1 Using the Battery ........................................................ 3-3
3.3.2 Installing the Battery of Recorder Base ...................... 3-4
3.3.3 Loading the Recording Paper..................................... 3-5
3.3.4 Connecting the Device to the Base ............................ 3-6
3.3.5 Connecting AC Power to the Base ............................. 3-7
3.3.6 Connecting the Grounding Cable ............................... 3-7
3.3.7 Using the DC Power Source....................................... 3-7
3.3.8 Connecting the Patient Cable and Electrodes (Applied
Part) ..................................................................................... 3-8
3.3.9 Inspections Before Power-On..................................... 3-9
3.3.10 Login and Account Management ............................ 3-10
3.3.11 Connecting the Printer ............................................ 3-11
3.3.12 Setting Up the Device ............................................. 3-12
3.3.13 Turning off the device ............................................. 3-13
3.4 Preparing the Patient ........................................................... 3-13
3.4.1 Preparing the Patient Skin ........................................ 3-13
3.4.2 Attaching Electrodes to the Patient .......................... 3-14
Chapter 4 Screen Introduction............................................................. 4-1
4.1 Main Screen........................................................................... 4-1
4.2 System Buttons...................................................................... 4-5
Chapter 5 Entering Patient Information ............................................... 5-1
5.1 Setting Patient Information .................................................... 5-1
5.2 Entering Patient Information .................................................. 5-2

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Chapter 6 Acquisition, Analysis and Printing....................................... 6-1
6.1 Selecting the Working Mode.................................................. 6-1
6.2 Selecting the Lead Mode ....................................................... 6-1
6.3 Setting ECG Waveform and Report ...................................... 6-2
6.4 Acquisition and Analysis ........................................................ 6-2
6.4.1 Auto Diagnosis............................................................ 6-2
6.4.2 AI Diagnosis................................................................ 6-4
6.5 Printing Reports ..................................................................... 6-5
6.6 Copying Reports .................................................................... 6-6
6.7 Freezing Waveforms.............................................................. 6-6
6.8 Report Examples ................................................................... 6-7
6.8.1 Auto mode .................................................................. 6-7
6.8.2 RR analysis................................................................. 6-9
Chapter 7 File Management ................................................................ 7-1
Chapter 8 System Settings .................................................................. 8-1
8.1 ECG Setup............................................................................. 8-1
8.2 Patient Info Setup .................................................................. 8-3
8.3 Sampling Setup ..................................................................... 8-4
8.4 Record Setup......................................................................... 8-5
8.5 Communication Setup ........................................................... 8-6
8.5.1 Wired Network ............................................................ 8-6
8.5.2 Mobile Network ........................................................... 8-7
8.5.3 WLAN Setup ............................................................... 8-7
8.5.4 Server Setup............................................................... 8-7
8.6 System Setup ........................................................................ 8-8
8.6.1 Display & Sound ......................................................... 8-8

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8.6.2 Date & Time................................................................ 8-8
8.6.3 Other Setup ................................................................ 8-9
8.7 System Maintenance ........................................................... 8-10
8.8 Factory Maintenance ........................................................... 8-10
Chapter 9 Prompt Messages and Troubleshooting ............................. 9-1
Chapter 10 Cleaning, Disinfection and Maintenance ........................ 10-1
10.1 Recommended Cleaning Agents....................................... 10-1
10.2 Cleaning............................................................................. 10-1
10.2.1 Cleaning the Device................................................ 10-1
10.2.2 Cleaning Patient Cable and Electrodes.................. 10-2
10.2.3 Cleaning the Thermal Print Head ........................... 10-2
10.3 Disinfection ........................................................................ 10-2
10.4 Care and Maintenance ...................................................... 10-3
10.4.1 Device and Recorder Base..................................... 10-3
10.4.2 Patient cable ........................................................... 10-3
10.4.3 Reusable Electrodes............................................... 10-4
10.4.4 Recording Paper..................................................... 10-4
10.5 Regular Maintenance......................................................... 10-5
10.6 Viewing System Information .............................................. 10-5
Chapter 11 Accessories..................................................................... 11-1
Appendix A Technical Specifications...........................................A-1
A.1 Safety Specifications .............................................................A-1
A.2 Environment Specifications ...................................................A-2
A.3 Physical and Hardware Specifications ..................................A-3
A.4 ECG Specifications ...............................................................A-6
Appendix B EMC and Radio Regulatory Compliance .................B-1

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B.1 EMC Compliance ..................................................................B-1
B.2 Radio Regulatory Compliance............................................... B-6
Appendix C Sensitivity Test and ECG Waveform Distortion TestC-1
C.1 Sensitivity Test ......................................................................C-1
C.2 ECG Waveform Distortion Test.............................................C-2

1-1
Chapter 1 Safety Guidance
This chapter provides important safety information related to the use
of the device. In other chapters, it also contains relevant safety
information for specific operations. In order to use the device safely
and effectively, please read and strictly observe all of the safety
information described in this manual before use.
1.1 Safety Warnings
1.1.1 Device Warnings
Warning
This device is not designed for direct cardiac application.
Warning
This device is not intended for treatment.
Warning
This device is not intended for home use.
Warning
This device is intended to be used by qualified physicians or personnel
professionally trained. They should be familiar with the contents of this
user manual before operation.
Warning
Only qualified service engineers can install this device.

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Warning
Only service engineers authorized by the manufacturer can open the
device housings.
Warning
Replacement of components by unauthorized personnel may lead to
unacceptable risks.
Warning
Do not open the device housings while the power is connected.
Warning
EXPLOSION HAZARD - Do not use the device in the presence of
flammable anesthetic mixture with oxygen or other flammable agents.
Warning
Do not use the device adjacent to or stacked with other device. If such use
is necessary, this equipment and the other equipment should be observed
to verify that they are operating normally.
Warning
This device cannot be used with diathermy related device.
Warning
Do not use this device in the presence of high static electricity or high
voltage device which may generate sparks.
Warning
Auxiliary equipment connected to the analog and digital interfaces must be
certified according to IEC standards (e.g. IEC 60950 for data processing
equipment and IEC 60601-1 for medical equipment). Furthermore, all

1-3
configurations shall comply with the valid version of IEC 60601-1. If in
doubt, consult our technical service department or your local distributor.
Warning
The summation of leakage current should never exceed leakage current
limits while several other devices are used at the same time.
Warning
Only the patient cable and other accessories supplied by Carewell can be
used. Otherwise, the performance, electric shock protection or defibrillator
protection cannot be guaranteed.
Warning
Make sure that all electrodes are connected to the patient correctly before
operation.
Warning
Make sure that the conductive parts of electrodes (including neutral
electrodes) and lead wires, do not come in contact with earth or any other
conducting objects.
Warning
Do not use dissimilar metal electrodes.
Warning
Indication of abnormal operation of the device: When the DC voltage at the
input terminal is increased to ±1V, the device will display lead off.
Warning
Check the main unit, patient cable and electrodes etc. before operating the
device. Replace the parts of evident defectiveness or aging which may
impair the safety or performance before use the device.

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Warning
Do not touch the patient and live parts simultaneously. Otherwise patient
injury may result.
Warning
To avoid risk of electric shock, do not touch the patient cable connector
when acquiring an ECG.
Warning
Do not carry out maintenance and repair of the device in use.
Warning
The frequency setting of AC filter should be consistent with the frequency
of local mains supply, otherwise, the anti-interference performance of the
device will be seriously affected.
Warning
Before connecting the device to the power supply, check that the voltage
and frequency ratings of the power supply are the same as those indicated
on the device label or meet the requirements specified in this manual.
Warning
If the integrity of the external protective conductor is in doubt, the device
should be powered by the built-in rechargeable battery.
Warning
Do not use sharp objects such as pens to touch the display screen,
otherwise it may damage the display screen.

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Warning
To avoid the risk of electric shock, when the device is used together with
the recorder base, be sure that the recorder base must only be connected
to a supply mains with protective earth.
1.1.2 Defibrillator and Pacemaker Warnings
Warning
When used with a defibrillator or pacemaker, all electrodes connected and
not connected to the patient and the patient should not be grounded.
Warning
Before defibrillating, make sure the patient is completely isolated and
avoid touching any metal part of the device in case of electric shock.
Warning
Before defibrillating, remove all electrodes, gel or cloth from the patient in
case of any possible burnt. When the electrode paddle of defibrillator is in
direct contact with these materials, the discharge capacity will cause
severe electric burn of patients.
Warning
Before defibrillating, enable the ADS function and select 0.67Hz filter.
Warning
Use patient cable with defibrillator protection specified by the manufacturer
while defibrillating. Otherwise there might be electric burnt of the patient or
damage of the device. After defibrillation, under the standard sensitivity
setting, the ECG waveform will return to 80% of the normal amplitude
within 5 seconds.

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Warning
During defibrillation, use disposable electrodes and ECG adapter wires
specified by the manufacturer and use them in accordance with their
instructions for use.
Warning
After defibrillation, the ADS filter is set at 0.67Hz, and the cardiogram is
displayed and maintained within 10 seconds.
Warning
Use only the patient cable and electrodes supplied by the manufacturer
while defibrillating.
Warning
For patient with a pacemaker, since this device has a pacing signal
suppression function, under normal circumstances, pacing pulses will not
be included in the pulse rate detection and calculation. However, if the
width of the pacing pulse exceeds 2ms, it is still possible to continue
counting the pacing pulse. To reduce this possibility, the operator should
closely observe the changes in the ECG waveform on the screen, and do
not rely on the indications of the device itself, when the device is used for
such patients.
1.1.3 Battery Warnings
Warning
Improper operation may cause the lithium battery (hereinafter called
battery) to be hot, ignited or exploded, and it may lead to the decrease of
the battery capacity. It is necessary to read this manual carefully and pay
more attention to warning information.

1-7
Warning
Danger of explosion - Do not reverse the anode and the cathode when
installing the battery.
Warning
Do not use the battery near a fire source or in the place where the
temperature exceeds 60℃. Do not heat the battery or throw it into fire. Do
not expose the battery to liquid.
Warning
Do not gouge the battery with metal, hammer or drop the battery or destroy
the battery by other means, otherwise it will cause the battery over-heated,
smoking, distorted or burning, even in danger.
Warning
When leakage or foul smell is found, stop using the battery immediately. If
your skin or cloth comes into contact with the leakage liquid, cleanse it with
clean water at once. If the leakage liquid splashes into your eyes, do not
wipe them. Irrigate them with clean water first and go to see a doctor
immediately.
Warning
Only qualified service engineers authorized by the manufacturer can open
the battery compartment and replace the battery, and only batteries of the
same model and specification provided by manufacturer should be used.
Warning
Stop using the battery when it reaches the end of its service life or any
abnormal phenomenon is found from the battery, and dispose the battery
according to local regulations.