Biocare-ECG101G Manual User

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About the User’s Manual

The User’s Manual serves for operating this instrument only. Our company shall not be
responsible for any consequences and liabilities caused by using this user’s manual for other
purposes.
The User’s Manual containing special information is under copyright protection. All rights
reserved. Copy, duplication or translation of the whole or any part of the User’s Manual is
prohibited in case of no prior written consent from our company.
Based on the need of product technical improvement or the file updates, we reserve the right
to modify the contents contained in this manual; if the changes do not involve safety issues, the
contents are subject to amend without notification
Due to technical upgrade or special requirements from users and with the precondition that
the performance of the instrument will not be lowered, some components may vary from the
description of configuration in the User’s Manual.

The explain for tagging in this manual

Warning : You should know the information for how to avoid the patients and medical staff
may suffer injury.

Note: You should know the information for how to avoid possible damage to equipment.

Explain:The important information you should known.

Version:1.1 2011-05
All rights reserved © Shenzhen Biocare Electronics Co., Ltd
Content

Content
Foreword .......................................................................................................................................... 1
Chapter 1 Common Matters Needing Attention ...................................................... 3
Chapter 2 Safety Matters Needing Attention .......................................................... 8
Chapter 3 Features and Operating Principles ........................................................11

3.1 Composition of the Product:................................................................................................................ 11

3.2 Appearance Description of the Product ............................................................................................. 11

3.2 Principle introduction and block diagram ......................................................................................... 15

Chapter 4 Preparation before Operation ................................................................. 19

4.1 Location selection ................................................................................................................................. 19

4.2 Loading of the recording paper........................................................................................................... 19

4.3 Connection of the power supply ......................................................................................................... 21

4.4 Connection of lead lines....................................................................................................................... 22

4.5 Start the instrument.............................................................................................................................. 22

4.6 Connection of electrodes ..................................................................................................................... 23

4.7 Indication for lead fail .......................................................................................................................... 26

Chapter 5 Operation Procedures .................................................................................. 28

5.1 Inspection before Operation ................................................................................................................ 28

5.2 Electrocardiogram recording screen .................................................................................................. 29

5.3 Electrocardiogram recording operation............................................................................................. 29

5.4 Copy of electrocardiogram waveform data....................................................................................... 46

5.5 Matters need attention during ECG waveform measurement and analysis:................................ 47

5.6 Explanation of the ECG Record Sample ............................................................................................. 47

Chapter 6 System Parameters Setting ....................................................................... 49

6.1 Main menu............................................................................................................................................... 49

6.2 Parameter setting .................................................................................................................................. 52

Chapter 7 Patient Information and Data Administration ................................ 54

User’s Manual for Electrocardiograph of ECG-101G --I--


Content

7.1 Patient Information Inputting.............................................................................................................. 54

7.2 Data Manage ........................................................................................................................................... 57

7.3 Management of Communication between the Product and Computer ......................................... 62

Chapter 8 Serv icing and Maintenance ....................................................................... 63

8.1 Matters needing attention about the repair and daily maintenance of the product................. 63

8.2 Maintenance and Replacement of the Built-in Battery ................................................................... 63

8.3 Recording paper ..................................................................................................................................... 64

8.4 Instrument maintenance after using .................................................................................................. 65

8.5 Inspection and maintenance of lead lines and electrodes ............................................................. 65

8.6 Maintenance of silicon rubber roll...................................................................................................... 66

8.7 Cleaning of the heat sensitive printing head .................................................................................... 66

8.8 Fuse replacement .................................................................................................................................. 67

Chapter 9. Common Malfunctions and Eliminating Methods ......................... 69


Appendix A Technical Specification ............................................................................ 72
Appendix B Other Product specifications and environmental requirements......... 74
Appendix C Package and Accessories ......................................................................... 75
Appendix D Output Code and Interpretation of Analysis ................................ 76

--II—User’s Manual for Electrocardiograph of ECG-101G


Foreword

Foreword

Thank you for choosing the digital electrocardiograph series products produced by the
company. In order to ensure the safety of you, the patient and the product, please carefully read
this manual before using, which can provide you with a series of safety reminders and application
guidance, helping you successfully reach the expected goal during the process of usage. In this
user’s manual, the descriptions with the symbol are matters needing especial attention,
which may involve information about the safe usage of the product, so please pay extreme
attention to those matters.

In order to provide assistance to users intuitively, the manual quoted some pictures as
reference. As the product undergoes improvements continuously, the detailed information on
parts of the pictures may be inconsistent with the actual situation, but these differences would
not affect the normal operation and interpretation of the users, so can be ignored. At the mean
time, the manual also described the expansion optional functions of the product, which can only
be realized when you have purchased the product with those optional functions, so please identify
it.

Digital electrocardiograph is used to record and display the biopotential signals generated by
the activities of the heart. It mainly uses ECG electrode to extract biopotential signals from
human body, which are transmitted, filtered and amplified through the lead input network,
transferred into numerical information by A/D, sent into the recorder and display after digital
processing, and thus the ECG waveforms can be recorded and displayed. In view of the
specialization of its applications, the product can only be used by medical personnel with
professional qualifications in hospitals, clinics or medical centers, as well as first aid sites. As the
complexity of the physiological structure of human body and the diversity of the causes of
diseases, the automatic diagnosis results given by the product are for reference only, which shall
be complemented by professional doctors’ comprehensive diagnosis according to the actual
situation of the patient.

According to the classification principles of Medical Electrical Equipment Part I: General


Requirements for Safety (IEC 601-1) the digital electrocardiograph is classified into the following
category:
z Anti-shock category: category I, equipment with built-in power supply.
z Anti-shock level: CF type applied part
z Degree of protection against harmful inflow liquids: normal equipment (enclosed
equipment with no protection against harmful inflow liquids.

User’s Manual for Electrocardiograph of ECG-101G --1--


-
Foreword

z Degree of safety when used with mixed gas of flammable anesthetic gas with air, oxygen
or nitrous oxide: the equipment cannot be used with mixed gas of flammable anesthetic
gas with air, oxygen or nitrous oxide.
z Duty: continuous running equipment.

Some symbols are used to represent specific information in the manual and the nameplate,
sign and mark of the product, which are listed as follows for you to recognize:

Note:

Refer to the menu of status setting for Information items and interpretations on the display
screen

--2—User’s Manual for Electrocardiograph of ECG-101G


Chapter 1 Common Matters Needing Attention

Chapter 1. Common Matters Needing Attention

★ The device is for the exclusive use of licensed physicians or personnel.


★ Please read the following precautions thoroughly prior to using this instrument.
★ Applicability: It is applicable to perform the routine diagnosis via electrocardiogram for
various medical therapy units, particularly in cases such as health examinations,
outpatient & emergency departments and wards of hospital.

Warning: The following measures should be taken when installing or storing the
instrument:

„ Keep the instrument away from splashing water, and do not use or install it where air pressure,
humidity, temperature, ventilation, air containing dust, sulfur, salt, alkaline gas and
chemicals might affect it .
„ Install the instrument on a stable plane, and prevent it from vibration and mechanical shock
when moving it.
„ Install it in a room with complete infrastructure.
„ There should be no high capacity machine such as high voltage cable , X-ray &ultrasound
device as well as diathermy machine around this electrocardiograph.

Warning:
„ The power supply should be capable of providing the proper voltage and frequency as
required in the instruction manual as well as sufficient capability.
„ Do not install the instrument in a chemical storage area or where gas is generated.

Warning: Prior to operation:


„ Check that the instrument is in a complete and normal condition.
„ Check that the instrument is properly installed.
„ Check that all cables are connected correctly and the instrument is grounded correctly.
„ It should be given particular attentions when using this instrument with other devices to avoid
misdiagnosis or other problems.
„ All circuits that contact the patients directly should be examined closely.
„ When battery used, please check the voltage and condition of battery first, charge and
discharge the battery, and keep the battery fully charged.

User’s Manual for Electrocardiograph of ECG-101G --3--


-
Chapter 1 Common Matters Needing Attention

Warning:In operation

„ The physician should observe the patients closely without leaving during the operation. Turn
off the power supply and remove the electrodes when necessary to ensure the safety of
patients.
„ Prevent the patients from contacting the other parts of the instrument and other conductors
except the electrodes.

Warning: After operation:

„ Turn all functional status back to the initial status , then turn off the power supply.
„ Remove the electrodes gently and do not pull the lead cable emphatically when removing the
electrodes.
„ Clear up the instrument and all accessories for the trouble-free operation for the next use.

Warning:

The maintenance and servings of this instrument should be performed by the experienced
technicians. When there is any functional abnormality with this instrument, it should be clearly
identified to prevent the instrument from running with fault.

Warning:

Do not make any modification to this instrument.

Warning:

Maintenance and servicing

„ The instrument should be subject to the maintenance and servicing regularly (Once half a
year at least)

„ Since the electrocardiograph is a measurement instrument, the users should have it verified
by the legal unit of measurement according to the << Verification Regulation of
Electrocardiograph>>, and the verification cycle should not be longer than 1 year.

„ The signal input/output ports (when needed to use) are only permitted to be connected with
devices of Class I which is in compliance with the standard IEC60601-1, and the total leak
current should be measured by the users to determine if it conforms with the requirement
and can be used after connection.
„ The electrical basic circuit and the list of parts are exclusively provided to the qualified
maintenance stations and personnel confirmed by our company.

--4—User’s Manual for Electrocardiograph of ECG-101G


Chapter 1 Common Matters Needing Attention

Warning:

Products treated after scrapped: the relevant packaging materials, depleted batteries and
scrapped products are treated, please remember to follow local laws, the user dispose
properly of the scrapped products and materials on the basis of the requirements of local laws,
and to support them recovery separation work.

The use of rechargeable batteries:

Warning:
Improper operation may cause the battery becomes hot, fire, explosion,
destruction or attenuation of the battery capacity. The use of Rechargeable
battery (hereinafter referred to as "Battery"), please read these
instructions carefully and use precautions.

Warning:

Polarity of the batteries can not be reversed, or could cause an explosion.

Warning:
Do not fire near the source or the environmental temperature exceeds 60 ℃
battery, do not heat the battery or thrown it into the fire.
Taken to avoid the battery by water splashes, do not drop the battery into the
water.

Warning:
Don’t chisel into the battery with metal chisel, hammering, or drop the battery or
use the other ways to damage the battery, otherwise it will create fat cells Heat,
smoke, deformation or combustion hazard.

Warning:
When you find the battery leakage or emit unpleasant odors, please go away
immediately. If the fluid leak into the skin or clothes on, immediately wash with
water. If the electrolyte leakage and enter the eyes, do not rub the eyes,
immediately with a clean water and see a doctor.

User’s Manual for Electrocardiograph of ECG-101G --5--


-
Chapter 1 Common Matters Needing Attention

Warning:
Only authorized installation or maintenance engineer can open the battery
compartment, replace the battery; and must use the same type of rechargeable
batteries which our company’s division to provide.

Warning:
When the battery lifetime to reach, or find the battery, smell, deformation,
discoloration or distortion, you should stop using the battery, And used batteries according to
local regulations for processing.

Warning:
You must turn off battery before plugging; otherwise it will appear black
and white, hang and so on.

Note:

Taken to avoid the equipment being splashed with water.

NOTE:

In this manual, the subsequent amendments (not including the corrections) or revised
editions of the dated reference documents are not applicable to this manual, and the
latest versions of the reference documents not dated apply to this manual.

Warranty:
For product warranty issues please refer to that "warranty cards" were provides the
content in accompanying document, if you have any questions, please call our customer
service consulting, customer service hotline: 800-830-6643.

Maintenance Warranty

Our company guarantees the new instrument on the material and technological qualification for
this product within 2 years since purchasing day, while accessories and consumables are not
covered by the guarantee in principle. This guarantee is also inapplicable to the products
undergoing any modification, disassembly, refitting or self-repairing without permission of our
company, as well as the products damaged by accidents, fire disaster, thunder and lightning, flood
and other disaster, intentional damage, improper installation and improper usage.

--6—User’s Manual for Electrocardiograph of ECG-101G


Chapter 1 Common Matters Needing Attention

★ Matters need attention on electromagnetic compatibility (EMC)


This instrument conforms with the IEC60601-1-2, a safety standard for medical electronic
devices or systems. However, the electromagnetic environment exceeding the limit or level
defined by the standard IEC60601-1-2 will introduce the unwanted interference to the
instrument, disable its intended functions or compromise its intended performance. Thus, if
there is any discrepancy with this instrument compared to its intended functions during
operation, please do not use it for longer until the adverse affect is identified and eliminated.
The appropriate preventing measures are given below by this manual for the such cases:

„ Affect from radiated electromagnetic wave:

The use of mobile phone may affect this instrument. Do instruct all the people around to turn
off their mobile phone or mini-radio devices when any medical electronic device is installed.

„ Affect from shock and conductible electromagnetic wave


The high frequency noise produced by other devices can be introduced into this instrument
through the alternating current socket. Please identify the noise source first, and if possible,
stop the working of related devices. If they are not allowed to be stopped, measures such as
application of noise abatement device should be taken to minimize the influence.
„ Affect from static electricity

The static electricity in a dry environment (indoor) may affect this instrument, especially in
winter. Humidifying eh indoor air or pre-discharge the static electricity on the cable and the
electrocardiogram recording personnel prior to using this instrument.

„ Affect from thunder and lightning

If there is thunder and lightning occurring around this instrument, a voltage shock may
be caused in this instrument. If it is considered as dangerous, you can pull off the plug of
power supply from the alternating current socket to run this instrument by its internal
power supply.

User’s Manual for Electrocardiograph of ECG-101G --7--


-
Chapter 2. Safety Matters Needing Attention

Chapter 2. Safety Matters Needing Attention

★ Please read this operation manual closely to learn the correct operation manners
thoroughly for sagely and effectively using this instrument.

Note:
This instrument should be installed on a smooth and stable working bench, and be prevented
from the intense vibration and shock when moving it.

Note:
The frequency and voltage of the alternating current should meet the requirement, and the
current capacity should be sufficient.

Note:
When the integrity of the protective wire is unsure, please use the internal DC power supply.

Note:
The applied part of circuit works in a floating ground condition, and the design conforms with
the safety standard for Type CF, thus it is able to record and display the electrical signal of
body surface generated by the activity of cardiac, but can not directly act on cardiac.

Note:
For the accuracy of the electrocardiogram tracing, this instrument should be installed in a
quiet and comfortable environment.

Note:
Turn off the instrument immediately if there is any abnormality occurring during the
operation.

Warning:
The power supply cable should be 3-core cable when using this instrument with the
alternating current; otherwise the hazards of electric shock may be introduced to the patients
and operators. When the available 3-core cable is unusable, please use the battery for power
supply.
Warning:
The room should be equipped with the complete power supply system and grounding system,
otherwise it might be harmful to the patients.

--8—User’s Manual for Electrocardiograph of ECG-101G


Chapter 2. Safety Matters Needing Attention

Warning:
When it is used in combination with the cardiac defibrillator, the contact with patient or
hospital bed should be avoided. All the electrodes which are connected or unconnected to the
patients as well as the patients themselves are not necessary to be grounded .All the
electrodes for use should be the Ag-Cl electrodes provided by our company . The patient cable
specially provided by our company should also be used for ensuring the protection against the
charging of the cardiac defibrillator. It is not recommended to use this instrument in
combination with the other electric stimulators. However, if necessary, they should be used in
the presence of professionals and under the appropriate directions. When the instrument is
used in combination with the cardiac defibrillator or the other electric stimulators (such as HF
surgical units), it is recommended to use the disposable chest electrodes in the shape of plate
to prevent the adhesive metal electrodes from burning the skin of patient.

Warning:
Be cautious when the patient is connected with more than one instrument, because the total
leak current may be harmful to the patient. Only the Class I devices in compliance with the
standard of IEC60601-1 are allowed to be connected to this instrument, and the total leak
current should be measured by the users to determine that if it meets the requirement and
can be used after connection.

Warning:
When the patient is connected with a cardiac peacemaker, the accuracy of ECG testing and
the analysis result might be affected. In this case, it is recommended for physicians to
perform the identification and analysis in combination with the waveform. However, the
potential risk will be increased in this case. Thus it should be given particular attention to the
safety problem when recording the ECG in this case, and the appropriate measures should be
taken to ensure the leak current at a acceptable level.

Warning:
Keep the high frequency electric knife away from the electrodes to prevent the patients from
burning. Make the electric resistance between the high frequency electric knife and patients’
body as low as possible, and be cautious particularly. If necessary, the plate electrodes can be
used because of its larger contact area to limit the high frequency current density into an
acceptable range.

User’s Manual for Electrocardiograph of ECG-101G --9--


-
Chapter 2. Safety Matters Needing Attention

--10—User’s Manual for Electrocardiograph of ECG-101G


Chapter 3 Features and Operating Principles

Chapter 3 Features and Operating Principles

3.1 Composition of the Product:

Composition of the product: the product is mainly composed of the main machine, leads,
limb electrodes and breast electrodes.

3.2 Appearance Description of the Product

„ Description of the Front Structure of the Product

1. Recorder
Install record paper and realize printing and output.

2. Display
LCD part, used to display the working status (or waveforms) of the product.

3.Control Panel
The controlling area of the product, through which the operator can conduct operations and
controls on the product.

4. Indicator Lamps
Indicate the working status of the product. The functions of the lamps are as follows (from left to
right): AC Working Indicator Lamp, DC Working Indicator Lamp, Charging Indicator Lamp.

User’s Manual for Electrocardiograph of ECG-101G --11--


-
Chapter 3 Features and Operating Principles

Note:
Do not put heavy objects on the LCD display or impact it, otherwise it may be damaged.

„ Description of the Various Function Keys on the Control Panel

1. ON/0FF Controlling Button to Turn the Machine On and Off.


Used to switch the status of the machine between On and Off. When there is any malfunction or
breakdown of the system, press this button and hold it for 3 seconds, and the machine can be
turned off.

2. mm/s(CH←) Recording speed control button/ character deleting button


① Change the recording speed of the recorder according to the requirements of the applications.
② In the Chinese Bopomofo input method, delete the currently input letter.

3. ( CH ) Copy button/Character confirmation button


① When the recording is finished, conduct the last time of data copying before the machine
turned off.
② In the Chinese Bopomofo input method, confirm the currently input letters.

4. OK Confirm Button
Confirm the selection of the options in the menu (or enter into the next level of menu).

5. LEAD( / ) Lead switching button


① In the recording status, used to switch the lead;
② In the menu setting status, used to select the parameters of setting.

6. START/STOP Recording start/stop control button


In various recording modes, used to start or stop recording.

7. RESET(▼) Closing button (▼)

--12—User’s Manual for Electrocardiograph of ECG-101G


Chapter 3 Features and Operating Principles

① In the standby status, used to close the lead signal;


② In the menu setting status, used to select options in the menu.

8. MODE(▲) Mode switching button (▲)


① Used to switch among various recording modes;
② In the menu setting status, used to select options in the menu.

9. Menu setting button


Press this button in the standby status to enter the menu, and in the menu status to exit the
menu.

10. (BACK) Sensitivity switch/return button


① Conduct sensitivity switch in the standby status;
② In the menu setting status, used to return to the upper level of menu.

11. 1mV(ID) ID button


① In the recording status, press this button to promptly print the ID sign;
② In the standby status, press this button to browse the information of the patient.

Note:
Do not use sharp objects to operate the control panel in order to prevent damaging the panel,
being shocked by contacting the internal circuit or damaging the product. Do not put
irrelevant objects on the control panel for a long time, because that will reduce the elasticity
of the control buttons on the panel and disable the panel functions.

User’s Manual for Electrocardiograph of ECG-101G --13--


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Chapter 3 Features and Operating Principles

„ Description of the Bottom Structure of the Product

1. Handle
Used to carry the product.

2. Fuse Base
With fuse inside.

„ Description of the Right Structure of the Product

1. Lead Input Interface


Connect to the lead.

2. Line Input/Output Interface


Line Input Interface: receives the input ECG analogue signals and conducts printing;
Line Output Interface: outputs the ECG analogue signals collected by the product.

3. RS-232 Interface
The data transmitting port to conduct communications with the computer.

--14—User’s Manual for Electrocardiograph of ECG-101G


Chapter 3 Features and Operating Principles

„ Description of the Rear Structure of the Product

4. AC Power Supply Switch


Used to connect and cut off AC power supply.

5. AC Power Supply Socket


Used to connect to AC power cord.

6. Equipotential Point (grounding post)


The equipotential connecting point when the equipment is used in connection with other facilities,
also the safe grounding point of the product.

3.2 Principle introduction and block diagram

1. Power supply
(1) Principle introduction about power supply
The alternating current can be transformed to be the direct current with a voltage of
about 20V through the voltage transformation or the switch power transformation. Thus
the internal rechargeable battery can be charged with stable voltage and limited
current. At the same time, the transformed current together with the battery output
can be transmitted to DC /AC switch circuit ,then transformed to be the main power
supply as +5V and +24V by the switch power stabilizer, and transformed to be +3.3V、
+1.8V and -5V through the power supply transformation.

The power supply with the voltage of +5V,+3.3V、+1.8V and -5V is supplied for the ground
circuit. The normal current load is 750mA approximately, the designed capacity is 3A,
and the current limiting reaction is at 3.75A.

+24V is for the paper driving unit and the printing head. The power supply to the paper
driving unit is in a manner of width adjustment and wave chopping to enhance the
efficiency of the driving unit. The normal current load is 500mA for the +24 power supply,
the designed capacity is 850mA and the current limiting reaction is at 1.2A.

User’s Manual for Electrocardiograph of ECG-101G --15--


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Chapter 3 Features and Operating Principles

The power supply for the floating ground circuit is from the output of AC/DC switch
circuit which is transformed by the self-excited switch power and the insulation pulse
transformer. The +5V power supply for digital part in the floating ground circuit is from
the direct output of switch power with invariable voltage, and the normal current load is
150mA with the designed capacity of 300mA. The +8V and -8V supplied for analogue part
of the floating ground circuit is from the variable voltage output of the switch power
which is transformed by the three terminal stabilizer, and the normal current load is
60mA with a designed capacity of 100mA.

(2) Block diagram for the principle of power supply (This electrical basic circuit
diagram and the list of parts are exclusively provide to the qualified maintenance
stations and personnel conformed by our company)

± 8V
Switch power source DC-DC converter CF-type part
+5V

+24V
DC-DC converter Recorder

+5V
Charger Logic switch
Control system Reset
+3.3V/+1.8V
DC-DC converter
-5V

Battery
14.8V

Keyboard
AC 100~240V
50/60Hz

--16—User’s Manual for Electrocardiograph of ECG-101G


Chapter 3 Features and Operating Principles

2 Amplification

(1) Principle introduction for the amplifying unit

The floating ground circuit of the whole instrument is a signal capture system which
consists of analogue circuit and A/D converting system. The analogue circuit is composed
of lead signal amplifier, anti-aliasing low-pass filter, channel switch, gain controller, lead-
fail detector, etc. The CPU system of the whole instrument is responsible to coordinate
the various circuits such as A/D converter, channel switch, gain controller and
lead-failure detector to perform the signal capturing and lead-fail detecting. The control
information between the floating ground and ground circuit and A/D converting data is
transmitted by the photocoupler.
The sampling rate for lead signal is 1000/960Hz, while the sampling rate for lead-fail
signal is 100/120Hz, and the cut-off frequency for anti-aliasing low-pass filter( -3dB) is
200Hz. The sampling rate conforms with the standards of AHA (American) and CSE
(European) which require that the sampling rate of electrocardiograph with the analysis
function should be no less than 500Hz. The anti-aliasing low-pass filter can limit the input
bandwidth of A/D converter while ensuring the wanted signal bandwidth to avoid the
signal aliasing caused by the sub-sampling of high frequency signal.

(2) Block diagram for the amplifying unit

Patient cable

Lead network
and buffers

Differentiate amplifier
& time constant net

Multiplexer

Gain selector

Buffers

A/D converter

MCU control

Photo coupler Control board

User’s Manual for Electrocardiograph of ECG-101G --17--


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Chapter 3 Features and Operating Principles

3 Controlling

(1) Principle introduction for the control unit

The control system is composed of printing controller, keyboard controller, liquid crystal
controller and CPU system, etc. The lead signal acquired by the signal capture system is
transmitted by the high speed photocoupler to the CPU system, then subject to the processes
of digital filtering, gain controlling and printing driving, finally transmitted to the printing
controller to perform the printing of the waveform. After printing, the waveform will be
measured, analyzed and processed by the CPU system. The CPU system can also receive the
interrupt signals and the key coding from the keyboard to perform the key interruption
processing. In addition, such functions as lead fail detection and paper compartment empty
detection, battery voltage control, automatic turning off the power supply, CRO analogue
output, sampling and printing for EXT input are all administrated by the CPU system. The
keyboard controller produces the keyboard scanning signals to perform the processing of
key-jitter elimination, then the key coding and the interrupt signal is received and processed
by the CPU system. The liquid crystal controller is responsible to the data and commands from
the CPU system to perform the displaying the control status of the whole instrument.

(2) Block diagram of the control unit

CRO EXT

Program Analog board


memory

Data Microprocessor
memory

Real time clock LCD controller

Recorder Programmable LCD


logic unit

Interface

Keyboard

--18—User’s Manual for Electrocardiograph of ECG-101G


Chapter 4 Preparation before Operation

Chapter 4 Preparation before Operation

4.1 Location selection

ECG-101G is not to be limited to be used in hospitals and clinics. Because of the portable
feature it can be used anywhere with the battery. It is applicable to outdoor occasions
such as group examination.

The following aspects should be considered when selecting the location to install this
instrument to recording the electrocardiogram accurately:
„ Keep the instrument and the bed for testing away from the high voltage cable. The
substantial radiation source around this instrument may introduce the noise interference
to this instrument.
„ Keep this instrument away from devices such as X-ray, ultrasound, radio machines and
fluorescence light because they are probably the substantial radiation sources.
„ Please use this instrument with the ambient temperature of 5℃~40℃.
„ Please use this instrument with the ambient humidity of 30%~80% (without
condensation).

4.2 Loading of the recording paper

ECG-101G can use the standard roll paper (63mm)

Thermal recording paper—roll paper-63mm


The product uses thermo-sensitive paper as the recording media. In order to get clearly
printed information, it is recommended to use the recording paper provided along with the
product or purchase the same type of recording paper from the company. As the thermo-sensitive
material is only sprayed on the front face of the recording paper, so the direction of the recording
paper must be correct during installation, otherwise the printing cannot be realized. The
installation sequence of the recording paper of the product is explained below:

User’s Manual for Electrocardiograph of ECG-101G --19--


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Chapter 4 Preparation before Operation

a. Press the button at the position pointed by the arrow in the figure below to make the paper
cartridge cover jump up and then remove the paper cartridge cover;

b. Install the paper reel into the paper barrel in the direction indicated in the figure below, and
put the paper barrel with recording paper into the paper cartridge and pull out a section of
recording paper by 6cm in length. Please be aware that the end of the paper reel with a
positioning pin must be installed into the corresponding clamping position in the paper
cartridge.

c. Align the gear on the paper cartridge cover to the gear position on the paper cartridge, and
press the end of the paper cartridge cover to lock it.

--20—User’s Manual for Electrocardiograph of ECG-101G


Chapter 4 Preparation before Operation

Note:
The product has a paper out warning function. When the printing paper in the paper cartridge
has been used up, the display interface of the product will appear warning information
(please refer to the chapter of “Warnings of the Product”). If the recording paper has not
been properly installed, the product would not find the recording paper, and the paper out
warning would not appear, then the installation of recording paper should be checked.

4.3 Connection of the power supply

1) Using the AC power supply


When the product uses AC power supply to work, firstly turn the AC power supply switch
at the back of the product to “○”position, and connect the opening end of the grounding wire
to the grounding post of the product, and then connect the other end of the grounding wire
with crocodile clips to the dedicated grounding point in the working environment. This kind
of grounding connection must be reliable, otherwise just use the AC power supply to charge
the battery of the product, and not directly use the AC power supply to run the product on
patients. When the grounding line is properly connected, insert one end of the power cord
provided along with the product to the AC input terminal of the product, and the other end
(plug) to the network power supply socket, as shown in the figure below.

When this instrument is used with other medical devices, please use the external
grounding cable provided together with this instrument. Connect the grounding terminal
of this ECG with the same grounding terminal of the other devices to prevent the patient
from the electrical shock. When there is any leak current with the other devices, this
connection will induce it into the ground for protection.

2) Using the battery


When the battery is required to be used as a power supply, the built –in rechargeable
battery can be used without loading by users. Please check the capacity and status of
the battery before use it.

User’s Manual for Electrocardiograph of ECG-101G --21--


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Chapter 4 Preparation before Operation

Note:
The reliability of grounding for this instrument can be enhanced by connecting one
end of the accessorial grounding cable onto the grounding column of the instrument
while connecting the other end to the ground. Do not use the water pipe or the
other pipes as a grounding cable, or else the safety protective measure of first level
of this instrument is ineffective, and the patients might be in danger of electrical
shock.

4.4 Connection of lead lines

The connecting position on the product to the lead is shown in the figure below. When the
plug of the lead is fully inserted into the lead socket of the product, turn the two fastening
bolts on the lead plug to lock the lead onto the product and prevent loosing.

Note:
Please use the lead provided along with the product, otherwise the working efficiency of the
product may be degraded and the product may be damaged.

4.5 Start the instrument

As the flowing picture, press the operating button of (ON/OFF), the power supply
indicator light will light and the instrument turns to be in a initial status,

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Chapter 4 Preparation before Operation

LCD displays the following screen:

When the instrument enters into the system and the following initial picture is displayed
on the LCD screen, it indicates that this instrument has entered into the stand-by status and
you can start operating.

4.6 Connection of electrodes

The connection of electrodes is critical for the accuracy of electrocardiogram recording,


thus please make sure the contact condition of the electrodes is good .New and old
electrodes, as well as the reusable and the disposable electrodes may not be used
simultaneously. If used, the quality of the recorded electrocardiogram may be affected to
a large extent. The electrodes and lead plugs are not allowed to contact the other

User’s Manual for Electrocardiograph of ECG-101G --23--


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Chapter 4 Preparation before Operation

surface or conductor such as the metal bed. If the electrodes replacement is needed,
please replace all the electrodes for once.

1) Electrodes connection onto limbs


The eletrodes for limb should be connected onto the soft skin of the limbs. Clean the skin
for electrodes connection with the medical alcohol first, then coat it with a little
electrodes cream. The electrodes for limbs should be connected as follows( see the
following picture):

R (RA) Connected onto the right hand


L (LA) Connected onto the left hand
RF (RL) Connected onto the right leg
F (LL) Connected to the left leg

2) Electrodes connection onto chest


Clean the skin of chest for electrodes connection with the medical alcohol. Coat the
electrode cream on these sites in a diameter of about 25mm as well as the edge of
adhesive plates of the electrodes. Compres the suction bulb of the chest electrodes to
make the chest electrodes adhere to the V1~V6 sites.The chest electrodes should be
connected as following picture:
C1 (V1) : 4th intercostal place at the right
margin of the sternum.
C2 (V2) : 4th intercostal place at the left
margin of the sternum.
C3 (V3) : Midway bettwen C2 and C4.
C4 (V4): 5th intercostal place at the left mid-
clavidular line
C5 (V5) : At the horizontal leve lof C4 , at the
left anterior axillary line
C6 (V6) : At the horizontal level of C4, at the
left mid-axillary line

Note:
The electrodes cream should be coated separately, and please prevent the electrodes
from contacting each other to avoid the short circuit. If the electrode cream is not
available , the ECG test should be performed for a short term as follows: Clean each site
for electrodes connection with the 75% alcohol , then conect the elctrodes onto them
immediately to ensure the electrodes contacting sites with a proper humidity. Do not

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Chapter 4 Preparation before Operation

replace the electrode sream with the physiological saline or else the electordes might be
corroded.

„ Comparsion tale between the line color and the corresponding eletrodes

LEAD European standards American Standard

Sites for Lead line Symbol for Color code Symbol for Color code for
electrode color electrod for electrod electrod electrod

Right arm Gray R Red RA White

Left arm Gray L Yellow LA Black

Right leg Gray N or RF Black RL Green

Left Leg Gray F Green LL Red

Chest 1 White C1 Red V1 Red

Chest 2 White C2 Yellow V2 Yellow

Chest 3 White C3 Green V3 Green

Chest 4 White C4 Brown V4 Blue

Chest 5 White C5 Black V5 Orange

Chest 6 White C6 purple V6 purple

User’s Manual for Electrocardiograph of ECG-101G --25--


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Chapter 4 Preparation before Operation

„ Lead modes and system diagram

4.7 Indication for lead fail

This instrument will check the lead connection all along, and if the lead fail is detected,
the detached lead line code willl be displayed in the approriate lead position.
The screen will display the following picture:

If the lead fail occurs, the approriate waveform will not be displayed, and the “record”
button is ineffective. The users should reconnect the electrodes or electrodes lead based
on the given information for the detached electrodes or the electrodes lead.When the

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Chapter 4 Preparation before Operation

lead lines failed off, it will no longer to analysis the wave, and the print report display
“lead is disconnected, cannot be analyzed”.

Note:
1.[*]:
① When the lead line with the patients or host is not reliable connectivity, ECG can
not correctly send, that “*” of the symbols is displayed to warn , "*" indicates the
current lead;
② when polarization voltage is over specified value of equipment, the symbol is
displayed to warn.

2. In the course of use, “*” of the symbols is displayed to warn the screen, to dealt
with according to the following approach:
① Press "lead shutting off " button to intervene manually, to eliminate the effects of
strength exceeds the value of the polarization voltage on the amplifier products, will
enable amplifiers rapid return to normalcy;
② Press "lead shutting off " button to intervene manually, still can not lift a state of alert,
they should double-check the connection of the corresponding electrode and the skin of
patient , the electrodes and l the lead lines or host of is reliable, when such a reliable
connection, the state of alert lifted.

User’s Manual for Electrocardiograph of ECG-101G --27--


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Chapter 5 Operation Procedures

Chapter 5 Operation Procedures

5.1 Inspection before Operation

„ Is the grounding connection correct?


„ Is the grounding wire complete?
„ Is the grounding wire connection normal?
„ Is the grounding bolt is tightened?
„ Is the connection between the grounding wire joint on the wall and the grounding wire
correct?
„ Is there any electrical equipment which may introduce the radio-frequency or the power
supply interference such as X-ray, ultrashort wave device around this instrument? If there is ,
they may introduce the interference to the ECG instrument. If necessary, please turn off
these equipment or perform the test in another location without interference.
„ Is the ambient temperature and humidity in compliance with the requirements for using this
instrument?
„ Is the connection of power supply cable good? Or is it intertwisted with other cables?
„ Is the connection of lead lines good? Or are the lead lines close to the AC power supply cable?
„ Is the connection between the lead line pins and appropriate electrodes correct?
„ Is the connection of electrodes good?
„ Is the electrode contacting skin of the tested patient subject to the appropriate
pretreatment?
„ Have the electrodes been contaminated? If they have, please remove the stains with the
alcohol and the soapsuds.
„ Is the connection of electrodes too loose? If it is, please tighten them.
„ Are the new and old electrodes used together?
„ Is there any contact between different electrodes (particularly in the chest area)
„ Is the tested patient too nervous? If he (she) is, please explain to the patient that the ECG
test is a simple process without any harm to the patient to relax him (her).
„ Is the tested patient acting or speaking?

„ Is the bed too narrow for the patient?


„ Do the naked parts of the patient body such as hand an foot contact the metal part of the bed?
If they do, the AC interference may be introduced to the electrocardiogram tracing.
„ Is the examination room comfortable?
„ Is the quantity of the recording paper sufficient?

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Chapter 5 Operation Procedures

Note:
For the safety of the examined patient and stability of the electrocardiogram recording,
the above inspection should be finished before operation. Make sure all the conditions
about the instrument and patient normal before electrocardiogram recording.

5.2 Electrocardiogram recording screen

Start the instrument and make sure all the lead connection is correct, and then the
electrocardiogram can be recorded. The following electrocardiogram recording screen
will be displayed on the LCD:

5.3 Electrocardiogram recording operation

To perform the electrocardiogram recording , Please choose a recording


mode( operating mode) first .There are two recording manners as automatic recording
and manual recording modes as the following picture:
One channel:

User’s Manual for Electrocardiograph of ECG-101G --29--


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Chapter 5 Operation Procedures

Three channel:

--30—User’s Manual for Electrocardiograph of ECG-101G


Chapter 5 Operation Procedures

„ Functions and Features of the Product in Various Recording Modes

Recording
Description of the Functions and Features Comment
Mode
On the recording paper, only the signals of one lead can be recorded in each
recording cycle in the longitudinal direction, and the lead can be automatically
changed when each recording cycle is finished, and the waveforms of the For
signals of all leads are recorded in the transverse direction (for 1 channel
Auto 1
example:Ⅰ→Ⅱ→Ⅲ→aVR→ and 3
aVL→aVF→V1→V2→ V3→V4→ V5→ V6, 12 recording cycles in all), and then channel
the results of automatic analysis can be printed or stored according to the
operator’s selection.
On the recording paper, the signals of two leads can be recorded in each
recording cycle in the longitudinal direction, and the lead can be automatically
changed when each recording cycle is finished, and the waveforms of the
signals of all leads are recorded in the transverse direction (for example, the For
recording sequence when the rhythm lead selection is II lead is as 1 channel
Auto 2
follows:Ⅰ+Ⅱ→Ⅱ+Ⅱ→Ⅲ+Ⅱ→ aVR+Ⅱ→ aVL+Ⅱ→ aVF+Ⅱ→V1+Ⅱ→ V2+Ⅱ→ and 3
V3+Ⅱ→V4+Ⅱ→ V5+Ⅱ→ V6+Ⅱ, 12 recording cycles in all), and then the results channel
of automatic analysis can be printed or stored according to the operator’s
selection. Among them, the second lead signal in the longitudinal direction is
the selectable rhythm lead signal.
On the recording paper, the signals of three leads can be recorded in each
recording cycle in the longitudinal direction, and the lead can be automatically
changed when each recording cycle is finished, and the waveforms of the
signals of all leads are recorded in the transverse direction(for example: Only for 3
Auto 3
Ⅰ+Ⅱ+Ⅲ→ aVR+aVL+aVF→ channel
V1+V2+V3→V4+V5+V6, 4 recording cycles in all), and then the results of
automatic analysis can be printed or stored according to the operator’s
selection.

On the recording paper, only the signals of one lead can be recorded in the For
longitudinal direction, the waveforms of the signals of the current lead are 1 channel
Manual 1
recorded continuously unless the lead is changed manually (for example: and 3
Ⅰ→ ……). channel

On the recording paper, the signals of two leads can be recorded in the
For
longitudinal direction, one of them is the currently selected rhythm lead, and
1 channel
Manual 2 the waveforms of the current lead and rhythm signals are recorded
and 3
continuously unless the lead is changed manually (for example, when the
channel
rhythm lead selection is II lead: Ⅰ+Ⅱ→ ……).
On the recording paper, the signals of three leads can be recorded in the
longitudinal direction,, and the waveforms of the signals of the current leads Only for 3
Manual 3
are recorded continuously unless the leads are changed manually (for example: channel
Ⅰ+Ⅱ+Ⅲ→ ……).
① Continuously display the signal waveform of the currently selected rhythm
lead;
Rhythm ② Conduct data acquisition first according to the selected time of acquisition, Only for 3
Analysis and then evenly distribute (within the time of acquisition) the acquired signal channel
waveforms in three lines of output, and print out the results of automatic
analysis.

User’s Manual for Electrocardiograph of ECG-101G --31--


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Chapter 5 Operation Procedures

„ Description of the Relevant Information on the Display and Recording Paper in Each Recording
Mode(Information shown in the following diagrams may be different in different parameter
settings of various options, so is for reference only)

1) Automatic recording
„ Auto1 (Automatic 1 channel)
The default recording mode of this instrument when leaving factory is “Automatic 1
channel” The whole instrument work status will be displayed on the LCD screen as the
following picture:

Observe that if the lead ECG waveform is stable in the rough from the displaying of

heart rate. If necessary, press the button of “lead shutting off” to stabilizer all the
lead waveform instantly.

a,Press button, you can choose other record mode ,such as "Auto 1 ","Auto 2 ","Manual
1 ", "Manual 2 ","Manual 3 "and "Rhythm”;

b,Press button to choose the speed, There are 4 levels of recording speed
provided by this instrument as :6.25 mm/s、12.5 mm/s、25 mm/s and 50 mm/s.

c. Press button, the parameter area appears red background, then select the filter

settings, and press the button to change the filter state. There are 4 types
of filter status provided by this instrument as : 0.05-150Hz、H50 d、H50 d 75Hz、H50 d
35Hz.

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Chapter 5 Operation Procedures

The following table is the detailed description about the various parameters in the filter
setting:

Status or Control Items Setting Value Comment

0.05-150Hz All filters are off.

Only AC filter and drift inhibition(0.5Hz Highpass)are


H50 d
on.

Filter Setting:
All filters are on, and the frequency of the
H50 d 75Hz
myoelectrical filter is 0.5-75Hz

All filters are on , and the frequency of the


H50 d 35Hz
myoelectrical filter is 0.5-35Hz

Note:

The H50 in the H50 d 75Hz will be displayed varying with the set AC frequency. For
instance , when the AC frequency is set to 60Hz, H60 d 75Hz will be displayed.
The default state of the flitter is 0.5-35Hz when boot scrap.

User’s Manual for Electrocardiograph of ECG-101G --33--


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Chapter 5 Operation Procedures

d. Press button (Starting /Stop button) to start recording. and the symbols of “ ”,

“ ” indicate the acquiring/ recording status respectively . The leading code which is
currently recorded will be displayed in the reverse type as the following picture:

After the ECG recording, system will automatic analysis and storage, it will display the
measurement result after analysis.

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Chapter 5 Operation Procedures

As shown above, in the measurement results interface, you can select "Print ", "Return"," MVB
","Edit "

Press button to move the selection box to the "Edit ", then press the
button, the report edit interface appears, as shown below:

In the Report Edit interface, there are such functions: Change, Add, Delete, Move up and
Move down. Specific operations please refer to Chapter 7 "ID input".

One standard waveforms recorded Legend:

User’s Manual for Electrocardiograph of ECG-101G --35--


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Chapter 5 Operation Procedures

MvB:

„ Auto 2 (Automatic 2 channel)

This mode is the automatic 2 channel, press the button (Mode switching button) to
select (Auto 2), LCD display the working status of machine, as shown below:

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Chapter 5 Operation Procedures

Observe that if the lead ECG waveform is stable in the rough from the displaying of

heart rate. If necessary, press the button of “lead shutting off” to stabilizer all the
lead waveform instantly.

a,Press button to choose the speed, There are 4 levels of recording speed
provided by this instrument as :6.25 mm/s、12.5 mm/s、25 mm/s and 50 mm/s.

b. Press button, the parameter area appears red background, then select the filter

settings, and press the button to change the filter state. There are 4 types
of filter status provided by this instrument as : 0.05-150Hz、H50 d、H50 d 75Hz、H50 d
35Hz.

c, Press button (Starting /Stop button) to start recording. and the symbols of “ ”,“ ”
indicate the acquiring/ recording status respectively . The leading code which is currently
recorded will be displayed in the reverse type as the following picture:
Two standard waveforms recorded Legend:

As shown above, the up line is the standard single-channel record mode, the downlink is the
rhythm mode, and you can set the rhythm lead in the menu. (see "Parameter setting").

„ Auto3 (Automatic 3 channel)


When the one-channel unit upgraded to three-channel unit, you can select
Automatic 3 mode.

User’s Manual for Electrocardiograph of ECG-101G --37--


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Chapter 5 Operation Procedures

This mode is the automatic 3 channel, press the button (Mode switching button) to
select (Auto 3), LCD display the working status of machine, as shown below:

Three standard waveforms recorded Legend:

--38—User’s Manual for Electrocardiograph of ECG-101G


Chapter 5 Operation Procedures

Note:

„ Under the automatic recording mode, the leads are unable to be changed through the

button during recording. The code of lead which is currently recorded will
be displayed in the reverse type. You can press the calibration button to print the
calibration signal during recording for examining the current sensitivity. However, in this
recording mode, the sensitivity is set to “Automatic Gain” and thus unable to be
adjusted.

„ This instrument possesses the function of automatic analysis, however, it just performs
the automatic analysis based on the acquired electrocardiogram waveform without
considering the total condition of the patient, and there may be some discrepancies
between the instrument’s automatic analysis result and the physician’s diagnosis result.
Thus the final conclusion should be made by the physician based on a multi-analysis and
diagnosis in combination with the analysis result, clinic symptom of the patient and the
other examination result.

2)Rhythm mode
When the one-channel unit upgraded to three-channel unit, you can select
Rhythm mode
This recording mode is a rhythm lead recording mode. The ECG data of the selected
rhythm lead can be acquired by this instrument within 60 seconds ~3 minutes (the duration
can be set in the menu). When the waveform acquisition is finished, the system will
analyze the acquired rhythm data automatically and can also printout rhythm lead
electrocardiogram waveform within a preset duration as well as the rhythm analysis result.

User’s Manual for Electrocardiograph of ECG-101G --39--


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Chapter 5 Operation Procedures

After starting the instrument , you can select the “Rhythm Mode” with the same
operating method of recording mode as “ Automatic 3 channel” .Then the instrument will
perform data acquisition for the designated rhythm leading. The work status of the whole
instrument will be displayed on the LCD screen as the following picture:

Observe that if the lead ECG waveform is stable in the rough from the displaying of

heart rate. If necessary, press the button of “lead shutting off” to stabilizer all the
lead waveform instantly.

a,Press button to choose the speed, There are 4 levels of recording speed
provided by this instrument as :6.25 mm/s、12.5 mm/s、25 mm/s and 50 mm/s.

b. Press button, the parameter area appears red background, then select the filter

settings, and press the button to change the filter state. There are 4 types
of filter status provided by this instrument as : 0.05-150Hz、H50 d、H50 d 75Hz、H50 d
35Hz.

c, When the waveform is stable, press button ((record / stop record button) to
start recording, after recording completely, it will automatically return to the state.

--40—User’s Manual for Electrocardiograph of ECG-101G


Chapter 5 Operation Procedures

Long time R-R period record waveform

Note:
On this mode, the sensitivity is "Auto SENS" and it can not be adjusted.

3) Manual Mode
This instrument provides manual mode for recording ECG waveform, 1 channel-unit
including “Manual 1 channel” and “Manual 2 channel” ; 3 channel-unit including 3 manual
recording modes such as “Manual 1 channel”, “Manual 2 channel”, “Manual 3 channel”,
Under the manual recording mode, you can switch to the wanted leading or leading group
freely. However, under this mode, the instrument is unable to perform analysis to the
acquired waveform and output the measurement result as well.

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Chapter 5 Operation Procedures

„ Manual 1 (Manual 1 channel)

After starting the instrument, you can Press button to select the “Manual 1
channel” with the same operating method of recording mode as “Automatic 1 channel”.
This mode is the manual mode corresponding to “Automatic 1 channel” mode, and the
work status of the whole instrument will be displayed on the LCD screen as the following
picture:

a,Press button to choose the speed, There are 4 levels of recording speed provided by
this instrument as :6.25 mm/s、12.5 mm/s、25 mm/s and 50 mm/s.

b,Press button to choose the ssensitivity, there are four levels::2.5mm/mv、5

mm/mv、10 mm/mv、20 mm/mv;

c,When the waveform is stable, press button ((record / stop record button) to

start recording, during the record process, you can press button to choose
the recorded lead group, the length of time for lead group is controlled by the user, the
recording lead code is highlighted , if interrupt or end the recording, please press the

button (Start/stop record)to return to the recording state.

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Chapter 5 Operation Procedures

ECG Legend of Manual mode

„ Manual 2 (Manual 2 channel)


This mode is the manual recording mode corresponding to the “Automatic 2 channel”,
and the work status of the whole instrument will be displayed on the LCD screen as the
following picture:

Note:
Please refer to the recording mode of “Manual 3 channel” for the detailed
operations and recording

User’s Manual for Electrocardiograph of ECG-101G --43--


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Chapter 5 Operation Procedures

„ Manual 3 (Manual 3 channel)


When the one-channel unit upgraded to three-channel unit, you can select manual 3
channel mode.
This mode is the manual recording mode corresponding to the “Automatic 3 channel”,
and the work status of the whole instrument will be displayed on the LCD screen as the following
picture:

Note:
Please refer to the recording mode of “Manual 3 channel” for the detailed operations
and recording

The lead switch sequence

Switch to right lead button (LEAD/ button) is for switch to the right lead in manual and rhythm
modes during recording.

The lead switch sequence in various recording modes is as follows:

Automatic 1 channel (Standard 1 channel automatic mode):


Ⅰ→Ⅱ→Ⅲ→aVR→aVL→aVF→V1→V2→V3→V4→V5→V6 →Ⅰ→Ⅱ→Ⅲ……

Automatic 2 channel (Standard 2 channel automatic mode):


Ⅰ,Ⅱ→Ⅱ,Ⅱ→Ⅲ,Ⅱ→aVR,Ⅱ→aVL,Ⅱ→aVF,Ⅱ→V1,Ⅱ→V2,Ⅱ→V3,Ⅱ→V4,Ⅱ→V5,
Ⅱ→V6 ,Ⅱ→Ⅰ,Ⅱ……

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Chapter 5 Operation Procedures

Automatic 3 channel (Standard 3 channel automatic mode,for 3-channel using):


Ⅰ,Ⅱ,Ⅲ→aVR,aVL,aVF→V1, V2,V3→V4,V5, V6→Ⅰ,Ⅱ,Ⅲ……

Rhythm mode (Rhythm lead analysis mode,Applies in the three channel)

Rhythm leading (Rhythm) can be changed in the menu setting, while it is also can be changed by

pressing the buttons before recording.

Manual 1 channel ( Standard 1 channel manual mode):


Ⅰ→Ⅱ→Ⅲ→aVR→aVL→aVF→V1→V2→V3→V4→V5→V6 →Ⅰ→Ⅱ→Ⅲ……

Manual 2 channel ( Standard 2 channel manual mode):


Ⅰ,Ⅱ→Ⅱ,Ⅱ→Ⅲ,Ⅱ→aVR,Ⅱ→aVL,Ⅱ→aVF,Ⅱ→V1,Ⅱ→V2,Ⅱ→V3,Ⅱ→V4,Ⅱ→V5,
Ⅱ→V6 ,Ⅱ→Ⅰ,Ⅱ……

Manual 3 channel (Standard 3 channel manual mode,for 3-channel using):


Ⅰ,Ⅱ,Ⅲ→aVR,aVL,aVF→V1, V2,V3→V4,V5, V6→Ⅰ,Ⅱ,Ⅲ……

Switch to left lead button ( button) is for switch to left lead in manual and rhythm modes
during recording, and the lead switch sequence is contrary to the right switch sequence.

User’s Manual for Electrocardiograph of ECG-101G --45--


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Chapter 5 Operation Procedures

5.4 Copy of electrocardiogram waveform data

When the electrocardiogram recording is finished, the recorded waveform can be copied

by pressing the button by users, and the instrument will copy the ECG data of the
previous patient and display it onto the screen automatically. You can press the
START/STOP button to trace the previous data, information about the patient and the
analysis result. The following screen will be displayed:

Note:
‹ The electrocardiogram of the previous patient can be copied by pressing the COPY button
only when 12-lead ECG waveform and data is analyzed and recorded in the non-manual
mode
‹ If the operation of instrument shutting down has been performed after the recording of
previous patient, the COPY button will be invalid.

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Chapter 5 Operation Procedures

5.5 Matters need attention during ECG waveform measurement and


analysis:

(1) When the myoelectric or the power supply interference is relatively strong, the
identification of P wave and Q wave is not always reliable. And the identification of
ST section and T wave may not be reliable because of the baseline drift.
(2) Sometimes the ending position of S wave and T wave turns to be blended and unclear,
and it might introduce the error to the measurement.
(3) When the detection of R wave is missed because of the Low voltage of QRS, there
might be a large error in the heart rate measurement.
(4) The calculation of electrical axis of heart and the demarcation point identification for
QRS wave is not always reliable because of the Low voltage of QRS.
(5) frequent (repetitive) premature ventricular contraction might be detected as the
representative beat occasionally .
(6) The P wave may be hard to be identified in presence of multi-arrhythmias thus the related
parameters may not be reliable

5.6 Explanation of the ECG Record Sample

3-channel
Three lines of standard ECG waveforms

User’s Manual for Electrocardiograph of ECG-101G --47--


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Chapter 5 Operation Procedures

Long time R-R period record waveform

--48—User’s Manual for Electrocardiograph of ECG-101G


Chapter 6 System Parameters setting

Chapter 6 System Parameters Setting

The system parameters of this instrument can be set in the menu.. The
displayed parameters in the menu are the factory default value, and the users can
set the parameters which need to be changed before electrocardiogram
recording.

6.1 Main menu

After starting the instrument , press the button to enter into the Menu setting

interface,users can press button to move the Move the selection box to
each option as shown below:

In the Menu setting interface, the pink background is the current selected

sub-menu, press button to enter the lower menu, press button to


move the selection box for the other option.

User’s Manual for Electrocardiograph of ECG-101G --49--


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Chapter 6 System Parameters setting

Parameters list:
Defaulting
Parameters Setting Value Comment
Value

LCD set Adjust the LCD contrast

Automatic analysis of report


Analyse output OFF,ON ON
output options
Select the width of the
Base width 1x、2x、3x、4x 2x
waveform baseline
Print mode Real time,sync Real time Select data collection print
mode
Language set English Setting the display language

Printer test Start Start Print a test triangle

0 Min、5 Min、10 Min 60


Power off 20 minutes Set Auto shutdown time
Min
Network Power Frequency
AC frequency 50Hz、60Hz 50Hz
Selection
Select Heart Rate Detection
QRS Beep OFF,ON OFF
tone switch

Sound set Select voice tone and switch

The current Year - month - day hour:


Time set XXXX-XX-XX XX: XX
time minute format input
Select the external input
Ext. Record OFF,ON OFF
signal record
Restore the state of factory
Restore set Activate Activate
setting

Input hospital name


Hospital Enter Enter
information

„ LCD set

Move the selection box to “LCD set”,press button and then press
button ,users can adjust the LCD contrast.

„ Print mode
Real-time print mode is based on changes in the human body in real time as a ECG
recording of printing method; The synchronization is the standard twelve lead ECG data
is synchronized, it means that each lead waveform situation at the same period of time .
Data for each lead is the same starting time. Users can easily observe the data of each
lead at the same time period.

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Chapter 6 System Parameters setting

Note:
Synchronous printing mode is only effective in the automatic mode.

„ Printer test
Move the selection box to “Printer set” , Press button , then the
instrument can print the triangle wave as shown below, Users can
observe the triangular wave whether there is a breakpoint,
bending or wave phenomena, and then test the print head is in
good condition or not.

„ AC frequency
This setting needs to match the frequency and use the AC, if you set it improper; it will
affect the mapping results and analysis.

„ External Record
External input is set as "On ", the machine enter into an external input screen, the screen
display as shown below:

User’s Manual for Electrocardiograph of ECG-101G --51--


-
Chapter 6 System Parameters setting

Press button(Start/Stop record button)to print the external input waveform.

„ Hospital information
Move the selection box to “Hospital”,press button to enter the hospital edit
interface:

Users can select the CH and EN to input, detailed operation please see Chpter7 “ Name
inputting”。

6.2 Parameter setting

In the main interface, press the button , and then

press button,users can move the selection box to set each parameter, as
shown below:

--52—User’s Manual for Electrocardiograph of ECG-101G


Chapter 6 System Parameters setting

Defaulting
Parameters Setting Value Comment
Value

0.5-150Hz,H50 d,
Filter setting H50 d 75Hz, Filter setting
H50 d 75Hz, H50 d 35Hz

The length of a single


Lead length 3s—12s 3s
channel recording time

Selection R-R duration lead


R-R length 30s—180s 60s
length

Rhythm Ⅰ,Ⅱ,Ⅲ......V4,V5,V6 Ⅱ Select the rhythm lead

White, black, red, green,


Select the display color of
Wave.color blue, yellow, pink, blue, white
lead
orange, purple

According to the need to


1CH 3CH / / upgrade single-channel to
three channel

Select the display mode of


Display mode 3,6,12 12
lead

„ Upgrade 1-channel to 3 channel

In the main interface, press the button,and then press button


to select 1CH 3CH as shown below

Enter the upgrade password, the system prompts: upgrade successful, please reboot.

Note:
After the upgrade, the user can not return to the 1-channel unit, please pay attention
when you want to upgrade!

User’s Manual for Electrocardiograph of ECG-101G --53--


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Chapter 7 Patient information and Data Administration

Chapter 7 Patient Information and Data


Administration

This chapter introduces how to input and display the patient information, as well as
operation procedures of storing and transmitting of ECG data.

7.1 Patient Information Inputting

In the main interface, press button, the patient information interface pops-up, after
setting it , press button to return to the main interface.

The screen displays the patient name, age, gender and ID number four setting items, users
can input the information according to the actual situation of the patient.

--54—User’s Manual for Electrocardiograph of ECG-101G


Chapter 7 Patient information and Data Administration

„ Name inputting

Moving the selection box to select "Name", and then press the button or the

button to move the selection box to the "EN" or "CH", users can press the

button again to switch the input mode.

Letters input
Select the input mode "EN", in the letter keyboard enter the corresponding letter,

and press the button to return to achieve the information inputting.

„ Age inputting

when users is inputting the Age , the system will automatically to stay the selection box
in the numeric keypad, in the numeric keypad, users can move the selection box to

select the desired number of input, and then press button to input the
information.

„ Sex selection
The default is "None", "None" means that in the report the gender column is blank, it is

filled by the doctor, press the button to select "Male", "Female" or "None ",

and then press button to return.

User’s Manual for Electrocardiograph of ECG-101G --55--


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Chapter 7 Patient information and Data Administration

„ ID
The machine automatically to give a unique ID number for collected ECG data ,and

named the ID number to store ECG data; in this option, press the button, the
instrument will prompt weather to clear ID(as shown below). Because the storing is
named by the ID number, if you choose "YES", it will result in duplication of storage, at
last resulting in data management confusion.

--56—User’s Manual for Electrocardiograph of ECG-101G


Chapter 7 Patient information and Data Administration

7.2 Data Manage

This instrument provides the storage medium internal memory for storing ECG ,Analysis
and measurement recording ECG data can be stored in the storage medium.

In the main interface, press button ,then press button to move the

selection box to “Data manage”, after selecting, press , the input interface will
display::

When the instrument complete an ECG recording, ECG analysis results, and patient
electrocardiogram data constitute a file saved in the default storage medium for Data
query and management in the future.

„ Internal Memory
The instrument’s internal memory can store up to about 2,000 copies of ECG data (the
actual situation according to the liquid crystal display). When the data storage is full, the
new ECG data will automatically replace the first ECG data.

The current state of storage media is displaying on the screen, Store file and the patient's
ID number in sequence to be storied, users can query and playback the waveform.
In the data storage screen, move the selection box to select the inspection ECG data, and

then press the button to pop-up such dialog box as shown below:

User’s Manual for Electrocardiograph of ECG-101G --57--


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Chapter 7 Patient information and Data Administration

There are four options for user using: "open", "Data retrieval", "upload" and "Format",
users can carry out the necessary processing and operations for ECG data.

„ Open file
Select "Open" option to playback the waveform and data access, LCD display the
following "data playback" picture:

This picture include 12-channel ECG waveform, the patient name, ID number , select the
paper speed and press the button to print this ECG data.
Print ECG data in the "Wave Playback" mode, the instrument will automatically to print it
as "Auto 3" mode, after printing the waveform, it will automatically to print the stored
analysis results and the patient name ,ID and time.

--58—User’s Manual for Electrocardiograph of ECG-101G


Chapter 7 Patient information and Data Administration

„ Data retrieval

Select ”Data retrieval” option,and press button:

There is "Name" and "ID" option in this dialog, in this dialog, users can retrieve the
required ECG data.

User’s Manual for Electrocardiograph of ECG-101G --59--


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Chapter 7 Patient information and Data Administration

„ Upload file

Select ”Upload” option,and press button:

Note:
The data transfer function must be related to the user has the hardware, software
support, Specifically refer to the instructions in this section," Management of
Communication between the Product and Computer

--60—User’s Manual for Electrocardiograph of ECG-101G


Chapter 7 Patient information and Data Administration

„ Format

Select ”Format” option,and press button:

The system prompts weather to format the memory, If format memory, the memory of all
the corresponding records will be deleted, and can not be restored, please be sure!

User’s Manual for Electrocardiograph of ECG-101G --61--


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Chapter 7 Patient information and Data Administration

7.3 Management of Communication between the Product and Computer

The product can conduct data transmission to computer through RS232 port. Before using this
function, make sure that the product has beend reliably connected to the computer through
RS232 cable, and that the ECG management software designed by the computer has been installed
in the computer. The connection between the product and the computer is as follows:

When the product is connected to the computer, select “ Transmission” in the function
menu of the product function and press button to realize data transmission.

Note:
1、RS232 connection cable should be the cable provided by the company along with the
ECG management software or with the same specifications as it.
2、For detailed functions and operations of the ECG management software, please refer to
the manual of ECG management software.
3、The ECG management software is an optional product, which can be purchases by
contacting business personnel of the computer in case of need.

--62—User’s Manual for Electrocardiograph of ECG-101G


Chapter 8 Servicing and Maintenance

Chapter 8 Servicing and Maintenance

8.1 Matters needing attention about the repair and daily maintenance of
the product

a. There is no part inside of the product that requires the user to conduct maintenance, the
user’s maintenance work normally involves the appearance cleaning of the product and
checking of the effectiveness of controlling buttons and integrity of the outer insulating
protection of the leads, thus the user should not dismantle the machine without approval;
b. When abnormal conditions of the product appear, mark the part with problem and conduct
repair immediately, and do not use products with malfunctions. As there may be high
voltage inside of the product that would be harmful to human, the repair of the product
must be conducted by specialists with qualification, no other person shall open the body
case of the product to conduct repair. The technical materials such as electrical schematic
diagram and parts list that are needed for the repair of the product can only be provided to
the repairing personnel with qualification;
c. Repair of product must be conducted according to the original design, and no model
alteration is allowed. After repair, the product must go through necessary safety
examination and measurements before it can be used;
d. The product and all its accessories must be maintained regularly, with a time interval no
longer than half a year.
e. The product is the force measuring instruments, users should statutory qualifications to the
local institutions to apply the measurement test, test period is not less than one year.

8.2 Maintenance and Replacement of the Built-in Battery

The built-in battery of the product is rechargeable battery which is installed inside of
the product. As the service life of rechargeable battery is related to the times of charging
and discharging, it is recommended to use AC power supply when the conditions permit to
prolong the service life of the rechargeable battery. The electric capacity of the built-in
rechargeable battery is displayed on the monitor of the product when using the battery to
work, so the user can know whether the battery needs recharge through observing the
electric capacity of the battery. When the battery is fully charged but the working time is less
than 30 minutes, or the battery cannot be recharged, the built-in battery may have lost its
effectiveness and should be replaced. As the body case of the product should be dismantled
to replace the built-in battery, the replacement of the built-in battery should be conducted

User’s Manual for Electrocardiograph of ECG-101G --63--


-
Chapter 8 Servicing and Maintenance

by professional maintenance personnel, and the user should not replace it on himself/herself
in order to avoid electric shock. Meanwhile, the rechargeable battery with the same
specifications must be used to replace the built-in battery to prevent accidents from
happening. The detailed steps to charge the battery, display the electric capacity and
protect the battery are explained as follows:

8.8.1 Recharging the Battery


There are battery charging and protecting circuits designed inside of the product. When
the AC power cord is connected, the battery can be charged. When the product is not use for
a long time, at least charge and discharge the battery every three months. When charging the
battery, turn the product into standby status, and open the power switch at the back the
product. During charging process, the charging indicator lamp on the front face of the
product will blink, and when the charging is completed the indicator lamp will illuminate
constantly.

8.8.2 Capacity Display of the Battery


When using battery to supply electricity, there would be a icon that represents the
capacity of the battery in the monitor after the machine is turned on, as shown in the figure
below. There are four shapes of the icon which indicate different capacities which are
explained below:

: Battery capacity is full;

: Battery capacity is sufficient;

: Battery capacity is not sufficient, needs recharge;

: Battery capacity is empty, needs immediate recharge;

8.3 Recording paper

For ensuring the quality of the ECG waveform tracing, the high speed heat sensitive
recording paper designated or provided by our company should be used. Using the
undesignated recording paper may cause problems such as the service life of heat sensitive
printing head falling , the unclear waveform recording and paper jam and should be given
particular attention.
(1) Do not use the recording paper coated with wax , and the paper in the color of ray or
black, or else the wax may adhere to heater of the printing head and lead to the printing
head failure or damage.

--64—User’s Manual for Electrocardiograph of ECG-101G


Chapter 8 Servicing and Maintenance

(2) High temperature, moisture and sunlight will cause the color change of the recording
paper, thus keep it in the dry and cool environment .
(3) Do not place the recording paper under the fluorescent light for long term or else the
recording quality may be affected.
(4) Do not place the recording paper with the PVC plastic material or else it may cause the
color change of the recording paper.
(5) When the recording paper is placed in cascade, the recorded waveform may be printed
from one piece to another one each other.
(6) Particular attention should be given to the size of the recording paper. The recording
paper of which size is not in compliance with the requirement may cause the damage of
the heat sensitive printing head or the silicon rubber roll.

8.4 Instrument maintenance after using

The following maters should be given particular attention after using the ECG instrument:
(1) Press the ON/OFF button on the control panel to set the instrument in the stand-by status.
(2) Hold the plug to pull off the power supply cable and the lead lines instead of holding the
cable.
(3) Clean up the instrument and accessories, then place the dust cover on it.
(4) Keep the instrument in the dry and cool environment. Prevent it from intense shock when
moving it.
(5) Do not soak this instrument into the detergent when cleaning it. Please cut off the power
supply first when cleaning the outer shell of the instrument . Please clean the instrument
with the neutral detergent instead of using the detergent containing alcohol or using the
sterilizer.

8.5 Inspection and maintenance of lead lines and electrodes

1 The continuity condition can be tested by the multimeter. Please inspect the contacting
condition of each lead line based on the following table . The electric resistance between the
electrode end and the lead plug pin for each lead line should be less than 10Ω. Please inspect
the continuity condition of the lead lines regularly, since the damage of any one line among
them will cause the false waveform of corresponding lead or the entire lead in the
electrocardiogram. The lead lines can be cleaned with the water and soap as well as
sterilized with 75% alcohol ( do not soak the lead lines into the liquid for sterilization).

Note: The electric resistance of the lead line with the protective function of
anti-defibrillation is 10KΩ approximately.

User’s Manual for Electrocardiograph of ECG-101G --65--


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Chapter 8 Servicing and Maintenance

Symbol for
R C C C C C C
connector R L F
F 1 2 3 4 5 6
plug
Position for 1 1 1 1
9 1 2 3 4 5
plug and pin 0 1 4 2

2. Bending the lead line in the sharp angle or knotting will decrease the service life of the lead
line, thus please perform the electrodes connection after tidying the lead line as possible .
3. The electrodes should be stored well. After using for long term, the oxidation color change
of the electrodes may occur due to corrosion and so on , and the electrocardiogram may
be affected. If this happens, please replace the electrodes in time.

8.6 Maintenance of silicon rubber roll

The silicon rubber roll should be kept in a stable, smooth and clean condition , or else the
quality of the ECG recording may be affected . To clean off the stain on the silicon rubber
roll, please wipe it along the long axis by a clean soft muslin with a little alcohol, while
turning the silicon rubber roll along the transmission direction of recording paper to clean
it entirely.

8.7 Cleaning of the heat sensitive printing head

The definition of the recorded waveform will be affected by the stain and dust on the
surface of heat sensitive printing head. To clean the surface of the printing head , you can
open the paper compartment cover after shutting down the instrument , then wipe the
surface of printing head gently by the clean and soft muslin with a little alcohol . The
residual contaminant on the printing head should be wetted with a little alcohol before
removing with the soft muslin. Do not scrap the surface of printing head with the hard
article or else the printing head will be damaged. Do not close the paper compartment
cover before the alcohol is evaporated entirely .The printing head should be cleaned
once per month when normally used.

--66—User’s Manual for Electrocardiograph of ECG-101G


Chapter 8 Servicing and Maintenance

8.8 Fuse replacement

If the AC power indicator light does not light when the AC power cable is connected and
the power switch at the back of the instrument is on , as well as the instrument is unable to
be started by pressing the ON button on the control panel or the battery status symbol
as is displayed after starting the instrument. If the AC power supply at the socket is
confirmed to be in a normal condition, it is probable that the fuse has blown. At this time the
AC power supply fuse should be replaced . The fuse is located in the internal portion of the
instrument and should be replaced by the professional or the manufacturer.

a. Cut off the AC power supply of the product;


b. Turn the product up side down and insert a screwdriver into the tube fuse seat at the bottom
of the product and turn the screwdriver until it is separate from the product;
c. Take out the tube fuse in the tube fuse seat to check whether the fuse is melted down, if so,
replace a tube fuse with the same specifications, otherwise check the other tube fuse;
d. Install the new tube fuse into the fuse cap and align it to the position of the original tube
fuse seat and use a screwdriver to fasten it clockwise;
e. If the two tube fuses are not damaged after inspection, but the product cannot work with AC
power supply, then the internal circuit may have malfunction, and the product should be
sent to repairing organization with qualification to be repaired;
f. When a new tube fuse is replaced and it is melted down when connecting power supply, then
there may be other potential troubles in the internal circuit of the product, and the product
should be sent to repairing organization with qualification to be repaired.

User’s Manual for Electrocardiograph of ECG-101G --67--


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Chapter 9 Common Malfunctions and Eliminating Methods

Chapter 9. Common Malfunctions and Eliminating


Methods

9.1 Phenomenon of malfunction: waveforms of some leads cannot be detected

during waveform recording.


Solution: There are several reasons for this phenomenon as follows:
1) When the product is connected to the patient, the internal baseline stabilization system
needs time to adjust, just wait for a while.
2) When the phenomenon occurs when all the leads are in good status of contact, just press
the lead closing button to quickly stabilize the waveforms of the channels.
3) There may be breakage of the leads, check the leads.
4) When the above reasons do not exist and this phenomenon still occurs, there may be
malfunction in the signal channel of the product, please contact the after-sales personnel of
the company or designated maintenance organization.

9.2 Phenomenon of malfunction: the waveform information printed has breaking

points in the vertical direction


Solution: normally it is because the surface of printing head is contaminated with dusts or dirt,
and it can be solved by cleaning the printing head after turning off the machine. If the
phenomenon still exist when the printing head is cleaned, then part of the heating units may
be damaged and need replacement. Please contact the after-sales personnel of the company
or designated maintenance organization to replace the printing head.

9.3 Phenomenon of malfunction: some buttons or all the buttons on the control

panel malfunction
Solution: its reason normally is that connecting parts of the control panel and the internal
circuits of the product may be loose or the control panel may be damaged. In this event, ask
professional maintenance personnel to open the upper cover of the product and reconnect
the connection parts of the control panel and internal circuit of the product, or replace the
control panel.

User’s Manual for Electrocardiograph of ECG-101G --69--


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Chapter 9 Common Malfunctions and Eliminating Methods

9.4 Phenomenon of malfunction: during recording process of the ECG, there are

disturbance of certain amplitude and order in the waveform, and there are obvious shakes
of the baseline (namely the AC interference) as shown in the figure below:

Solution: it may be cause by the following reasons. Please check and eliminate the causes in
sequence:
1)Whether the product is properly grounded?
2)Whether the connection of electrodes and leads are correct?
3)Whether conductive grease is smeared at the parts of skin that contact the electrodes?
4)Whether the metal patient bed is properly grounded?
5)Whether the patient contacts the wall or the metal parts of the patient bed?
6)Whether there is any one who contacts the patient?
7)Whether there is any electrical equipment with high power working? (Such as X-ray set or
ultrasonic products).
When the above causes are checked in sequence and no problem has been found and the
disturbance cannot be eliminated still, please set the AC interference filter to current status in
the product menu to effectively restrain the disturbance.

9.5 Phenomenon of malfunction: the baseline shakes abnormally on the ECG


waveform (namely the muscle electricity disturbance) as shown in the figure below:

Solution: the cause to this phenomenon is mainly the over nervousness of the patient. Please
check and eliminate the following causes in sequence:
1)Whether the environment and ambient temperature are convenient?
2)Whether the patient is overly nervous?
3)Whether the patient is overly nervous by the narrowness of bed?
4)Whether the patient spoke during recording process?

--70—User’s Manual for Electrocardiograph of ECG-101G


Chapter 9 Common Malfunctions and Eliminating Methods

5)Whether the patient feels inconvenient by the tightness of the electrode clamps on the limbs?
When corresponding measures are taken to solve the above causes and the disturbance still
exists, please set the muscle electricity disturbance filter to the current status on the product
menu to effectively restrain the disturbance. However, after conducting the above measure, the
ECG waveform recorded will be attenuated a little, especially for the R wave, so the doctor
should pay attention to that.

9.6 Phenomenon of malfunction: the baseline of ECG waveform moves up or down


irregularly (namely the baseline is unstable) as shown in the figure below.

Solution: The reason to this phenomenon is the instability of signals acquired. Please check
and eliminate the following causes in sequence:
1)Whether the installation of electrodes is stable?
2)Whether the connection of the leads and electrodes are reliable?
3)Whether parts of the patient’s skin that contact the electrodes are clean?
4)Whether limbs of the patient move or the breath of the patient is uneven during recording
process?
5)Whether the old and new electrodes are use together during recording process?
When corresponding measures are taken to solve the above causes and the disturbance still
exists, please set the baseline drift filter to the current status on the product menu to effectively
restrain the disturbance

User’s Manual for Electrocardiograph of ECG-101G --71--


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Appendix A Technical Specification

Appendix A Technical Specification

1)Main unit

Lead Standard 12-lead


Acquisition mode Simultaneous 12-lead acquisition
Input mode Floating input, have defibrillation protection effect and pacing pulse suppression
Automatic 1 channel,Automatic 2 channel,Manual 1 channel,
1-channel
Manual 2 channel
Recording format Automatic 1 channel,Automatic 2 channel,Automatic 3 channel,
3-channel Rhythm mode,Manual 1 channel,Manual 2 channel,Manual 3
channel,
Record in appropriate format and automatic lead switch with
Automatic
measurement and analysis function
Recording mode
Record in appropriate format and manual lead switch without
Manual
measurement or analysis function.
Long term recording Record for a long term (30-180 sec.) and rhythm analysis
Measurement Ventricular rate, PR interval, QRS time limit, QT/QTC interval,
parameters: P/QRS/T axis, RV5/SV1 amplitude and RV5+SV1 amplitude
Input CIR current ≤0.1μA
Input impedance >50MΩ
Patient leak current <10μA
Time constant ≥3.2s
Frequency response 0.05~150Hz
Sensitivity threshold ≤20μV(10Hz)
Noise level ≤15μVp-p
Standard Sensitivity 10mm/mV
Scaling Voltage 1mV
Polarization resistance
±500mV
Voltage
External input ( EXT) Single-ended input
Input impedance ≥100kΩ
Sensitivity: 10mm/V
External output (CRO) Single-ended output
Output
≤100Ω
impedance
Sensitivity 1V/mV
Filter AC: 50Hz, ≥20dB
EMG: 35Hz or 75Hz(-3dB)
Sensitivity 2.5 mm/mV, 5 mm/mV, 10 mm/mV, 20mm/mV
Record speed 6.25mm/s, 12.5mm/s, 25mm/s, 50mm/s

--72—User’s Manual for Electrocardiograph of ECG-101G


Appendix A Technical Specification

2) Recorder

Record mode Hot array printing system


Resolution ≥8dots/mm (Vertical)
≥16dots/mm(25mm/s);≥8dots/mm(50mm/s)(Horizontal)
Paper speed 6.25 mm/s,12.5 mm/s,25 mm/s,50mm/s

Recording Paper Specifications Width of 63mm rolls

3) LCD

Display on LCD The whole instrument work status, time, heart rate, and with the
backlight

4) others:

Lead lines Standard 12-lead wire protection without defibrillation


Safety Classification IEC60601-1:2005 ClassⅠ Type CF

power supply AC:100 V -240V,50Hz,30VA

DC:12V-1800mAh, Ni-MH battery

Fuse specification 2-Φ5×20mm AC latency fuse


T800mA/250V

User’s Manual for Electrocardiograph of ECG-101G --73--


-
Appendix B Other Product Specifications and environmental requirements

Appendix B Other Product specifications and


environmental requirements

B.1 Dimensions and weight

Length × width × height 360mm×325mm×86mm

Packing size 400mm×300mm×200mm


Net weight 3.0Kg
Gross weight 4.3Kg

B.2 Environment requirements

1 Transportation
Environment temperature -20℃~+55℃
Relative humidity 25%~95% (No condensation)
Air pressure 70KPa~106KPa
In accordance with the requirements stipulated in the contract order, the transport process to prevent
rain and sun.

2 Storage
Environment temperature -10℃~+40℃
Relative humidity: 25%~80%
Air pressure 70KPa~106KPa
The packaging of ECG stored in the non-corrosive gases and well-ventilated room.

3 Using
Environment temperature +5℃~+40℃
Relative humidity: 30%~80%
Air pressure 86KPa~106KPa

--74—User’s Manual for Electrocardiograph of ECG-101G


Appendix C Package and Accessories

Appendix C Package and Accessories

C.1 Accessories Along with the Machine

The standard configuration of the product normally contains the following accessories and
documents in the following table with the quantities indicated below. When there are
additional accessories contained in the user’s order or contract, they will be listed in the
product packing list, and the content of the table below will not be adjusted, so please check
and accept the delivery according to the items in the product packing list.

Instrument of ECG-101G 1 unit

Patient Cable 1 piece

Limb Electrode 4 pieces

Chest Electrode 6 pieces

Power Cable 1 piece

Grounding Cable 1 piece

Thermal Recording Paper 1 piece

User’s Manual 1 copy

Qualified Certificate 1 copy

Packing List 1 copy

Certificate list 1 copy

C.2 Matters Needing Attention


1) When opening the casing, check the integrity of packing case fist, and refuse to accept the
product when the appearance of the packing case is damaged. When opening the packing
case, please start with the top side of it;
2) After the case is opened, the user should check the accessories and documents according to
the product packing list, and contact the business personnel of the company in case of
unconformity;
3) Do not electrify the machine to conduct test run when the body case of the product is
damage, and contact business personnel of the product immediately for treatment in that
case;
4) Do not use accessories other than the originally provided accessories of the product,
otherwise the performance and safety of the product may be affected;
5) The packing case must be properly kept for use in case of transportation for maintenan

User’s Manual for Electrocardiograph of ECG-101G --75--


-
Appendix D Output code and Interpretation of Analysis

Appendix D Output Code and Interpretation of


Analysis

8 Arrhythmia

Code No. Description

8002 Marked rhythm irregularity


8110 Sinus rhythm
8102 Sinus arrhythmia
8108 Marked sinus arrhythmia
8120 Sinus tachycardia
8130 Sinus bradycardia
8200 Atrial rhythm
8210 Atrial fibrillation
82101 Atrial fibrillation with rapid ventricular response
82102 Atrial fibrillation with slow ventricular response
82103 Atrial fibrillation with aberrant conduction, or ventricular premature complexes
82108 Atrial fibrillation with rapid ventricular response with aberrant conduction
82109 Atrial fibrillation with slow ventricular response with ventricular premature complexes
8220 Atrial tachycardia
8250 Atrial flutter
82503 Atrial flutter with aberrant conduction or ventricular premature complexes
82505 Cannot rule out atrial flutter
8300 Junctional rhythm
8320 Junctional tachycardia
8400 Supraventricualr rhythm
8420 Supraventricular tachycardia
8430 Supraventricular bradycardia
8470 with occasional supraventricular premature complexes
8474 with frequent supraventricular premature complexes
8475 with frequent supraventricular premature complexes in a pattern of bigeminy
8500 Ventricular rhythm
8520 Ventricular tachycardia
8570 with occasional ventricular premature complexes
8574 with frequent ventricular premature complexes
8575 with frequent ventricular premature complexes in a pattern of bigeminy
86006 Electronic atrial pacemaker
86007 Electronic ventricular pacemaker
8901 Undetermined regular rhythm
8902 Undetermined rhythm
8970 with occasional ectopic premature complexes
--76—User’s Manual for Electrocardiograph of ECG-101G
Appendix D Output code and Interpretation of Analysis

8974 with frequent ectopic premature complexes


8975 with frequent ectopic premature complexes in a pattern of bigeminy

6 AV Conductive Defect

Code No. Description


611 Possible third degree AV block
621 Second degree AV block, Wenckebach type
622 Second degree AV block, Mobitz type II
623 First degree AV block
631 Short PR interval
641 Type-A WPW syndrome
642 Type-B WPW syndrome
643 Atypical WPW syndrome
644 Intermittent WPW syndrome

7 Intraventricular Conductive Defect


Code Description
No.
711 Left bundle branch block
712 Incomplete left bundle branch block
721 Right bundle branch block, plus possible RVH
722 Right bundle branch block
723 Incomplete right bundle branch block
724 RSR in lead V1/V2, consistent with right ventricular conduction delay
731 Left anterior fascicular block
741 Nonspecific intraventricular conduction block

User’s Manual for Electrocardiograph of ECG-101G --77--


-
Appendix D Output code and Interpretation of Analysis

1 Myocardial Infarction
Code No. Description
1113 Cannot rule out anterior myocardial infarction, probably old
1114 Cannot rule out anterior myocardial infarction, age undetermined
1121 Possible anterior myocardial infarction, possible acute
1122 Possible anterior myocardial infarction, probably recent
1123 Possible anterior myocardial infarction, probably old
1124 Possible anterior myocardial infarction, age undetermined
1131 Anterior myocardial infarction, possible acute
1132 Anterior myocardial infarction, probably recent
1133 Anterior myocardial infarction, probably old
1134 Anterior myocardial infarction, age undetermined
1213 Cannot rule out anteroseptal myocardial infarction, probably old
1214 Cannot rule out anteroseptal myocardial infarction, age undetermined
1221 Possible anteroseptal myocardial infarction, possible acute
1222 Possible anteroseptal myocardial infarction, probably recent
1223 Possible anteroseptal myocardial infarction, probably old
1224 Possible anteroseptal myocardial infarction, age undetermined
1231 Anteroseptal myocardial infarction, possible acute
1232 Anteroseptal myocardial infarction, probably recent
1233 Anteroseptal myocardial infarction, probably old
1234 Anteroseptal myocardial infarction, age undetermined
1313 Cannot rule out anterolateral myocardial infarction, probably old
1314 Cannot rule out anterolateral myocardial infarction, age undetermined
1321 Possible anterolateral myocardial infarction, possible acute
1322 Possible anterolateral myocardial infarction, probably recent
1323 Possible anterolateral myocardial infarction, probably old
1324 Possible anterolateral myocardial infarction, age undetermined
1331 Anterolateral myocardial infarction, possible acute
1332 Anterolateral myocardial infarction, probably recent
1333 Anterolateral myocardial infarction, probably old
1334 Anterolateral myocardial infarction, age undetermined
1413 Cannot rule out septal myocardial infarction, probably old
1414 Cannot rule out septal myocardial infarction, age undetermined
1421 Possible septal myocardial infarction, possible acute
1422 Possible septal myocardial infarction, probably recent
1423 Possible septal myocardial infarction, probably old
1424 Possible septal myocardial infarction, age undetermined
1431 Septal myocardial infarction, possible acute
1432 Septal myocardial infarction, probably recent
1433 Septal myocardial infarction, probably old

--78—User’s Manual for Electrocardiograph of ECG-101G


Appendix D Output code and Interpretation of Analysis

1434 Septal myocardial infarction, age undetermined


1513 Cannot rule out lateral myocardial infarction, probably old
1514 Cannot rule out lateral myocardial infarction, age undetermined
1521 Possible lateral myocardial infarction, possible acute
1522 Possible lateral myocardial infarction, probably recent
1523 Possible lateral myocardial infarction, probably old
1524 Possible lateral myocardial infarction, age undetermined
1531 Lateral myocardial infarction, possible acute
1532 Lateral myocardial infarction, probably recent
1533 Lateral myocardial infarction, probably old
1534 Lateral myocardial infarction, age undetermined
1613 Cannot rule out inferior myocardial infarction, probably old
1614 Cannot rule out inferior myocardial infarction, age undetermined
1621 Possible inferior myocardial infarction, possible acute
1622 Possible inferior myocardial infarction, probably recent
1623 Possible inferior myocardial infarction, probably old
1624 Possible inferior myocardial infarction, age undetermined
1631 Inferior myocardial infarction, possible acute
1632 Inferior myocardial infarction, probably recent
1633 Inferior myocardial infarction, probably old
1634 Inferior myocardial infarction, age undetermined
16132 Cannot rule out inferior myocardial infarction with posterior extension, probably old

16142 Cannot rule out inferior myocardial infarction with posterior extension, age undetermined
16212 Possible inferior myocardial infarction with posterior extension, possible acute
16222 Possible inferior myocardial infarction with posterior extension, probably recent
16232 Possible inferior myocardial infarction with posterior extension, probably old
16242 Possible inferior myocardial infarction with posterior extension, age
Undetermined
16312 Inferior myocardial infarction with posterior extension, possible acute
16322 Inferior myocardial infarction with posterior extension, probably recent
16332 Inferior myocardial infarction with posterior extension, probably old
16342 Inferior myocardial infarction with posterior extension, age undetermined
171 Abnormal Q wave ? [ Lat. ]
172 Abnormal Q wave ? [ Inf. ]
173 Abnormal Q wave ? [ Lat., Inf. ]
174 Abnormal Q wave ? [Ant. ]
175 Abnormal Q wave ? [ Ant., Lat. ]
176 Abnormal Q wave ? [ Ant., Inf. ]
177 Abnormal Q wave ?

3 Ventricular Hypertrophy and Atrial Enlargement


User’s Manual for Electrocardiograph of ECG-101G --79--
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Appendix D Output code and Interpretation of Analysis

Code No. Description


311 Possible right ventricular hypertrophy
312 Right ventricular hypertrophy
313 Right ventricular hypertrophy, probably repolarization abnormality
321 Minimal voltage criteria for LVH
322 Possible left ventricular hypertrophy
323 Moderate voltage criteria for LVH
324 Voltage criteria for LVH
325 Left ventricular hypertrophy, probably repolarization abnormality
331 Possible left atrial enlargement
332 Left atrial enlargement
341 Possible right atrial enlargement
342 Right atrial enlargement

5 ST-T Abnormality
Code No. Description
51 ST abnormality, possible subendocardial ischemia
52 T wave abnormality, possible subendocardial ischemia
53 Nonspecific T wave abnormality
54 ST depression
55 Nonspecific ST elevation
561 Possible acute pericarditis
562 Acute pericarditis
571 ST elevation, possible acute myocardial infarction
572 Tall T wave, possible hyperkalemia

2 Axis Deviation

Code No. Description


21 Moderate left axis deviation
22 Abnormal left axis deviation
23 S1-S2-S3 pattern
24 Abnormal right axis deviation
25 Right axis deviation
26 Indeterminate axis

9 Others
--80—User’s Manual for Electrocardiograph of ECG-101G
Appendix D Output code and Interpretation of Analysis

Code No. Description


911 Low voltage
912 Low voltage in limb leads
913 Low voltage in chest leads
941 Long QT interval
942 Short QT interval
971 Dextrocardia ?
972 LIMB LEADS REVERSED
973 Abnormal QRS-T angle
974 Consistent with pulmonary disease
981 Artifacts present
982 Cannot be analyzed, re-record recommended

10 Overall Judgment
Code No. Description
1010 Normal ECG
1011 Borderline ECG
1012 Atypical ECG
1013 Abnormal rhythm ECG
1014 Abnormal ECG

Note: The output codes may be subject to changes without notice.

User’s Manual for Electrocardiograph of ECG-101G --81--


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