TLC9803 User Manual-258635641

TLC9803 Dynamic ECG Systems User Manual
Foreword
This user manual describes features and request of this product, main structure, function, specification,
correct method for transportation, installation, usage, operation, repair, maintenance and storage, as well
as the safety procedure to protect both the user and equipment. Refer to the respective chapters for
details.
Please read this user manual before using the product, and operate according to this manual strictly. As
for abnormality, human injury and equipment damages caused by wrong operation, which violates the
rules in manual, our company without responsibility for this kind of danger and will not maintain free
for this kind of malfunction.
The information contained in this document is subject to change without notice.
I
CONTENTS
Chapter 1 Introduction ...............................................................................................................................

1.1 Environment condition .....................................................................................................................
1.2 Product feature .................................................................................................................................
1.3 Safety................................................................................................................................................
1.4 Maintenance and cleaning ................................................................................................................
Chapter 2 Frame Character of Product.......................................................................................................
2.1 Sketch map for every orientation .....................................................................................................
2.2 Definition of keystoke, interface and indicator light ........................................................................
Chapter 3 Preparing work before Using.....................................................................................................
3.1 Electrode placement .........................................................................................................................
3.2 Battery installation and notice ..........................................................................................................
Chapter 4 Recorder Operation Explanation ...............................................................................................
4.1 New record .......................................................................................................................................
4.2 Review record ..................................................................................................................................
4.3 System set.........................................................................................................................................
4.4 Replay record ...................................................................................................................................
Chapter 5 Malfunction analysis and Troubleshooting................................................................................
5.1 The problem related to the battery ...................................................................................................
5.2 The problem related to the skin and the electrode. ...........................................................................
5.3 The problem related to the cable and the input plug ........................................................................
5.4 Other problems .................................................................................................................................
Chapter 6 Instructions for Analysis Software ............................................................................................
Appendix Ⅰ Technical Specification ...........................................................................................................
II
Chapter 1 Introduction
1.1 Environment condition
The environment requirement of operation, transport and storage for Dynamic ECG System:
Operation Environment:
Environment Temperature: 10℃~45℃
Relative Humidity: ≤85%
Atmospheric Pressure : 86 kPa~106 kPa
Power Supply: DC 3V
Transport and Storage Environment:
Environment Temperature: -40℃~+55℃
Relative Humidity: ≤85%
Atmospheric Pressure: 86 kPa~106kPa
1.2 Product feature
TLC9803 Dynamic ECG Systems contain recorder & analysis software. Recorder is an easy- to -use unit,
which collects 3-lead ECG waveform synchronously and records continuously for 24 hours. In addition,
it also reviews ECG waveform. It is easy for you to use analysis software which plays back ECG
waveform stored in ambulatory recorder and achieves kinds of analysis functions, such as arrhythmia,
HRVA, etc.
1.3 Safety
The design of TLC9803 Dynamic ECG Systems accords with the international safety standard
IEC60601-2-47.
Warning:
Please don`t use this device with the defibrilation device.
Please don`t operate this device in environment containing flammable anaesthesia gas.
Please don`t use this device when scanning MRI.
Please don`t use device which has High level electromagnetic radiation in the vicinity of the
recorder.
The device is not intended for synchronous gathering.
Notice:
TLC9803 Dynamic ECG Systems must be operated by the personnel who has been trained and
authorized. Person specially assigned for safe keeping.
Please read this user manual carefully before using the product, and operate according to this
manual strictly.
The environment where the device will be used should be reasonably free from vibration, dust,
1
corrosive or combustible matter, and shun extremes of temperature and humidity, and so on.
Doctor must tell patient monitored by recorder not to do much movement.
Please insert the batteries properly in the right direction for the improper insertion may damage
the device.
For protecting environment, please deal with the batteries according to the local rule of law.
1.4 Maintenance and cleaning
The recorder can be cleaned with hospital-grade ethanol and dried in air or with dry and clean cloth.
Please take out the batteries if the recorder is not in use for a long time and proper safekeeping.
2
Chapter 2 Frame Character of Product
2.1 Sketch map for every orientation

2.1.1 Front view
Fig.2-1 Front view

2.1.2 Planform
Fig.2-2 Planform
Notice: While connecting lead wires, please refer to lead wires indicator in Fig.2-4.
2.1.3 Side view
Fig.2-3 Side view

2.1.4 Bottom view
Fig.2-4 Bottom view

3
2.2 Definition of keystoke, interface and indicator light
function key: marker/affirmance/choice
function key: menu/cancel/turn on/off
direction key: left
direction key: right
direction key: go up
direction key: go down

indicator light: (glint every 4 seconds when collecting ECG signal)
Show date transfers state when connecting with the computer.
4
Chapter 3 Preparing work before Using
3.1 Electrode placement
Notice :
The placement of electrode is the basic of holter recorder collecting ECG data signal. The quality
and position of electrode affect the quality of ECG signal. Please read this chapter carefully before
first operation.
Position of the electrode placement is shown as Fig.3-1.
Fig.3-1
 Deal with the skin
When attaching and placing the electrode, we need to deal with the skin at first, and be sure to clean the
skin. Use 95% alcohol to scrub the skin, after the alcohol evaporates, use abrasive paper attached to the
electrode to wipe the attached place to remove cuticula on the surface of the skin in order to reduce the
resistance from the skin and the disturbance from the EMG. People who have much hair need to shave it
to ensure the skin well connected with the electrode. The skin of old patients is dry and has many
crinkles, so we have to clean the skin and make the attached place flat. If the attached place is near the
bosom of the woman patient, electrode and cables should be covered by the bra and then fixed well.
 Place the electrode
Use high-quality ECG electrode to attach the right place and connect with the correspond electrode. To
prevent the electrode drop and the baseline excursion caused by pulling, use the medical adhesive belt or
plaster to fix every electrode and cable properly. After the cables get together, use the adhesive belt to fix
in the abdomen; the rest cables can be tucked into the recorder`s waistband. Don`t use the common
adhesive belt to attach the cables for fear of dirtying, corroding the cables and reducing the usage life
span. If use the device in the environment of high temperature or easy perspiring, "EKG Medical Gel"
could be wiped on the skin around the electrode beforehand.
3.2 Battery installation and notice

3.2.1 Open the battery cover according to the direction which the arrowhead on the cover
5
indicates. Follow as Fig.3-2.
Fig.3-2
3.2.2 Please insert the batteries properly in the right direction, and then close the cover. Follow as Fig.3-
3.
Fig.3-3
3.2.3 The state of battery and working requirements are shown as Table 3-a1.
The batteries are full, the device could run in gear.
The batteries are insufficient, suggest not record.
The batteries are almost drained, please replace the battery immediately.
Table 3-a1
When the batteries are almost drained and not replaced, the recorder will show the interface as Fig.3-4,
and turn into protected mode.
Fig.3-4
When the energy of battery is low, the recorder turn into protected mode in order to protect the recorder
from damaging.Under protected mode the device don`t run until the device is electricized by USB or the
batteries are full.
Warning:
The batteries should be full when the device collects new information, otherwise the recording
time could not last long enough.
Notice:
6
Please confirm all eletrodes and lead wires are connected well to patient. Otherwise, interference
in waveform at the beginning of record may lead to failure analysis.
7
Notice:
Please take off the battery after monitoring in order to protect the recorder from damaging
because of battery leak.
8
Chapter 4 Recorder Operation Explanation
Press for about 3 seconds to turn on the recorder (press for about 3 seconds to turn off the
recorder on the main interface), the main interface is shown in Fig.4-1.
state time Battery State
Option area
Choice state
Fig.4-1 Main interface

4.1 New record
Use or to choose on main interface, press to enter new record operation,

display interface is as Fig.4-2.
Fig.4-2
On the interface, press or to change the gain, press or to switch lead status.
After recording one time, press if you want to continue to record, here the interface will show the
information "Last record will be covered !Are you sure ?" as Fig.4-3.
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Fig.4-3
Press to cancel recording and return to the main interface.
Press to continue to record and the interface will show the information "Starting record" as Fig.4-
4.
Fig.4-4
The interface as Fig.4-4 will last 2 seconds, then the recorder enter stand-by mode. The blue indicator on
the top left corner of recorder will glitter one time every 4 seconds to show the state in gear.
Press for about 3 seconds to record event marker when recording, in the meanwhile, the beep
from recorder indicates you have succeeded in event marker.
Press for about 3 seconds when recording if you want to end recording manually, then the
recorder will show the information as Fig.4-5 to affirm whether the recording operation will be stopped.
Fig.4-5
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If you confirm that you want to terminate recording, please press for about 3 seconds according to
the information shown on the interface, at the same time the screen will display the information as Fig.4-
6. This interface will last about 2 seconds, then return to the main interface.
Fig.4-6
4.2 Review record
Use or to choose on main interface, press to enter review record operation

interface, if the recorder has storage record, there will be a interface as Fig.4-7.
Lead state marker
waveform display
starting time
Fig.4-7
Under this interface, use or to change lead marker (V1, V3, V5) , press to switch
between hour, minute and second, the red one shows the option which has been chosen, use or
to change the value.

If the recorder hasn`t storage record, there will be a "No record" information on the screen as Fig.4-8,
and the interface will return main interface automatically after 2 seconds.
Fig.4-8
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4.3 System set
①
②
③
④
⑤
Fig.4-9
Use or to choose on main interface, press to enter the "system set" interface
as Fig.4-9
Use or to choose the option, use or to set the option which has been chosen
or enter the inferior menu, the red one shows the option which has been chosen.
① Auto shutdown set
The time scope of auto shutdown is 3~98 seconds, if setting 99s, the recorder will be on forever.
② keypad tone set
Under this option, you can decide the keypad tone "ON/OFF".
③ Demo mode
Under the item, the demonstration waveform is shown in Fig.4-10.
Fig.4-10
Press to switch ECG lead waveform. User can choose 3-lead ECG waveform or single ECG
waveform displayed on the OLED screen.
④ system initialization
Press to enter the interface as shown in Fig.4-11.
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Fig.4-11
Notice:
Detailed edition information depends on current recorder.
Press to enter the initialization interface as shown in Fig.4-12.
Fig.4-12
⑤ Time set
Press to enter the time set interface as Fig.4-13.
Fig.4-13
Use or to choose the option, use or to change the value, press to save
the setting and return superior menu. Press to cancel setting and return superior menu.
4.4 Replay record
Please remove electrodes from patient, and then connect recorder to PC with USB cable. It is
recommended that batteries should be remained in the recorder. The indicator light is on, and the
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interface displays the information as shown in Fig.4-14 if the connection is normal.
Fig.4-14
In "My computer" of PC, there is a symbol as Fig.4-15.
Fig.4-15
Open the disk, you can see a file named ECG_WAVE.BIN, as Fig.4-16.
Fig.4-16
Please choose this file of analyse software to perform the replaying operation.
14
Notice:
Please refer to the information of chapter 6 for the detail.
After replaying, please safely remove USB Mass Storage Device as Fig.4-17, then pull out USB
connecting line to avoid damaging the device.
Fig.4-17
After cutting the connection with PC, this device will go back to the main interface.
Notice:
The USB interface of recorder is USB2.0, please choose the USB2.0 interface in PC to connect in
order to make sure the speed of data communication.
15
Chapter 5 Malfunction analysis and Troubleshooting
5.1 The problem related to the battery
Problem Cause Correction
1.The battery is used up. Change another battery.
The recorder has no 2.The battery can`t connect with Change another brand of battery.
response and the the reed very well. The height of or put a thick of metal piece in
indicator isn`t light after "+" of some brand of battery is too the place between the "+" of
the battery is put in. low. battery and reed.
3.The direction of the battery is Install the battery correctly once
wrong. again.
1.The quality of the battery is poor.
Change another high-quality
or the battery has been put for a
new battery.
long time.
The record time of the
recorder can`t reach 24 Recommend to use the battery
2.The battery can`t be charged
hours. whose capacity is over
enough.
1000mAh.
3. The characteristic and brand of
Change another new battery.
the battery are different.
1. If the voltage is above 3.5V,
which beyond the working voltage,
Please contact our company.
part of the electron hard disk may
The data can`t be cleared be broken.
away.
2. Some part of the recorder may
be damaged because the electrolyte Please contact our company.
in the battery flows out.
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5.2 The problem related to the skin and the electrode.
1. The skin can`t be cleaned well,

Clean the skin and attach once
or the electrode isn`t attached
more.
right.
The wave is disturbed; the

2. The quality of the one-off
quality of the ECG signal
electrode is poor, or the electrode Use new, high-quality electrode.
is poor.
has been stored for a long time.
3. The movement of the patient`s Ask the patient to avoid severe

upper limbs is too severe. movement when monitoring.
The amplitude of some

ECG wave is small, which The cable is broken. Change a new cable.
is difficult for analysis.
5.3 The problem related to the cable and the input plug
Please check if the needles of the

1. The recorder isn`t connected plug is curved, broken or lack. If
well. the plug is well, please connect
The output wave of the once again.
recorder is a straight line.
2. The cable is broken. Please contact our cmpany.
3. The recorder is broken. Please contact our cmpany.
Connect the cable once again

1. The cable isn`t connected well
Some ECG wave is according to the operation manual.
disturbed a lot, and the
quality of ECG signal is 2. Lead cable is broken. Please change a new one.
poor.
3. The quality of the one-off Please change new, high-quality
electrode is poor. electrode.
5.4 Other problems

There is something wrong with the
Change another USB cable.
USB cable.
The communication of
data is failed. The USB interface of computer
don`t match the USB interface of Use 2.0 interface.
the recorder.
17
Chapter 6 Instructions for Analysis Software
Turn on the computer and enter the WINDOWS98/2000/XP operation system. Double click the
TLC9803 graph on the desktop, then enter the TLC9803 Dynamic ECG operation systems as Fig.6-1.
Fig.6-1
Replay HOLTER recorder
Connect the HOLTER recorder with PC. Click the "New" in the menu of "File" or click , and
input the new patient information.
If the recorder use SD memory,please choose the collection file ECG_WAVE.BIN as Fig.6-2 up
first.Certainly you could also copy the case history to other place,then choose.If the recorder use Flash
memory,please turn to Fig.6-2 down.
18
Fig.6-2
Attention: If the patient takes a pacemaker, choose "Yes" in the item "pacing", then the system
can add the function of pacing analysis.
After the patient's data input, click , and the computer begins to read data from the recorder.
The prompt as Fig.6-3 will pop up when the communication finishes. Here click to enter
the interface of arrhythmia analysis(as Fig.6-5), and click to enter the template replay
interface(for the case which has been analysed) or the order replay interface(for the case which has not
been analysed).
19
Fig.6-3
Attention: If the patient takes a pacemaker, the pace maker parameters setup interface (as Fig.6-4)
will pop up before arrhythmia analysis interface appears. Here doctors need modify the following
items according to patient's pace maker parameters. Thereinto the accuracy of pacing pulse
analysis relates to the "high" or "low" of pacing pulse, usually it should be "common", if the
pulse is very low, please choose the "high".
Fig.6-4
20
Fig.6-5
The left side of the interface (as Fig.6-5) is the waveform display window, displaying the waves of all
analysed leads. Here operators need choose a meaningful wave to diagnose and adjust the value of ST
segment. Look at the picture. The three colored lines from left to right are baseline point, ST segment
beginning point, and ST segment ending point. If you want to adjust a line, click this line to select it, and
then move it through "←→" on the keyboard.
The right side of the picture is the control view, the "Artificial Analyzen" option is designed for
extending function.
If the current wave is good, please click the "Accept" button, and then the system enters the arrhythmia
analysis (as Fig.6-6) automatically. If the user wants to exit this program, please close direct. If the
current wave is not good, please click the "Refuse" button, then the system will show the waves
constantly until you click "Accept" to enter the arrhythmia analysis.
Click the "▼" button at the right of "Show Lead" to choose main analytical lead.
RR refractory period: This parameter is general 300ms, it means the shortest time between the two heart
beats, the default value is 300ms, the user can adjust it according to the specific circumstance, if the
patient`s heart rate is too quick, it should be set as low as possible, in order to prevent losing the analysis
for some heart beats.
Click the options under the "Leads Analysed" to decide which leads to be analysed, the default is 3-lead.
When the amplitude of the case`s wave is too low, please choose "H" in the resolution option ("Height").
When the case meets much disturbance, please choose "H" in the "distinguish O" Option. The options
"Height" and "distinguish O" don`t need to adjust generally. The user can choose according to the actual
circumstances.
21
3-lead wave in-phase
Choose
analyzing
leads
HR trend graph
3 minutes RR interval trend graph
Fig.6-6
Click "Stop", the system will stop temporarily. User can browse the 3 lead ECG through "←↑→↓" on
the keyboard. In the HR trend graph, there is a green symbol line, which represents the place of the
current wave. User can go back to a point, change condition ("Leads Analysed", "Height", "distinguish
O"), click "Start", the part starting at the green sign will be analysed again. (as Fig.6-
Green sign
7) .
Fig.6-7
When the analysis stopped, press "←↑→↓" on the keyboard to go back to certain point to analyse again
if necessary.
Function explanation of edit module
Represent: Arrhythmia analysis module, Template replay module,

Order replay module, HRV analysis module, HRT module, TWA module.
Go to the previous operation go to the next operation.

◇ Scroll bar usage
Click the "▲▼" at the right side of the Window or scroll bar to change the content shown in the window.
◇ Change window size
Move the mouse arrowhead to the side of box, when the arrowhead turn to "↔"or"↕", press the left
22
keypad of mouse and don`t set free until drag to the wanted location.
◇ Screen interface distributing
Click into the template replay module (as Fig.6-8).
template
cluster
template
window
Double click
here to
magnify the
Wave show
wave
Fig.6-8
The left window is the template window. Every button is a template. The letter in the button represents
the type (For example: V means ventricular premature beat, S means atrial premature beat), the
percentage means what percentage this kind is in the total. No percentage means no wave.
V: ventricular premature beat module AF: atrial flutter module

S: supra premature beat module Af: atrial fibrillation module
N: normal beat module vF: ventricular flutter module
L: long intermission module vf: ventricular fibrillation module
O: Interference module
The top right window is display window for the selected template in the template cluster, which displays
every waveform.
The bottom right window is the waveform show window, which displays the detailed informtion of the
waveform which the mouse is pointing.
classifying parameter adjustment function (as Fig.6-9).
23
Number of Threshold
class Limit Value
Parameter
name
Parameter
distribution graph
Fig.6-9
Parameter name: the name of the parameter to be classfied.
Number of class: set how many classes the parameter will be cassfied. It can be increased or decreased
by “▲” or “▼” buttons. When it increases 1, the numbers of both the threshold limit value at its right
and the the boundary in the parameter distribution graph will also increase 1, and the reverse is true. The
number of class should be among 1 and 7.
Threshold Limit Value: the value of the corresponding boundary in the parameter distribution graph.
Parameter distribution graph: take example for the area distribution graph of QRS wave.
Fig. 6-10 shows the distributing graph of the wave. The y-axis is the number of QRS wave, the abscissa
is the value of wave. The classified line corresponds to the editor box above. Move the line by draging
the pane on it to change its threshold limit value. The blue triangle on the left is the amplificating staff
guage, you can change the magnification factor of the y-axis the by draging it up and down with the left
key of the mouse.
amplificating
staff guage
Can be draged
24
Fig.6-10
QRS complexes shape: select it to sort the waves according to QRS shape.
Page forth Page back
The page number of The page of the

the displayed ECG displayed waveform
When the number of classification is large, it’s used to turn the pages.
The number in the middle means the current page.
The number in the square means the number of the waves. The two
rectangles on the right mean there are two parameters to be classified,
including height and interval. The number of diamonds in quadrate bar is
the classified number according to the parameters.The purple square
means the place of the wave. Keep the left button down, drag the wave
into the classify moulding board. It can change the class of these waves.
Class by shap Class by width Class by RRI Ratio Select insert waves
Add new class
Class by O Class by Height Class by RRI Class by QRS Area
When clicking the buttons above, the system calculates the proper circumscription of the classification,
and divides the parameter into some kinds automatically. For example, when clicking the "Class by O"
button, the system calculates the proper circumscription of the classification, and divides the parameter
into three kinds automatically. When clicking the "Class by Shap" button, the system will divide into
four kinds automatically. When clicking the "Class by Height" button, the system will divide into three
kinds automatically.
Wave display window. As follow.
is "Select insert waves" button. When clicking this button, the system will select the inserting
waves out to make the user easy to edit.
Open dialog box to add a new class.
25
Right button editor menu

Click the right button of mouse, and then an editor menu will be opened.
Change the class module; at

the same time put the
waveform, which is
changed into the module.
Shortcut key
"V", "S", "N", "L" are the shortcut key to put the chosen wave into that class.
"Page up", "page down", "home", "end", "^", "v"mean page up, page down, to the beginning of the page,
to the end of the page, up and down.
Control graph display key
Remove the ECG in the left window up
Remove the ECG in the left window down
Remove the ECG in the left window left
Remove the ECG in the left window right
Amplify the ECG in the left window
Lessen the ECG in the left window
Cancel the edit operation
Recover the edit operation
26
Display or hide the statistics
Display or hide the time
Choose all the ECG in the left window
Reverse choice the wave in the left window
Cancel choice in the left window
Order replay module
Click the button and enter order replay module.

The picture is the order replay picture of main analysis lead. And the doctor can choose the wave of
other leads. As Fig.6-11.
Waveform area
Event Marker
Trend graphic
area
Trend graphic
area
Fig.6-11
Put the arrowhead on the ECG and click the right key of the mouse, then appear the menu as Fig.6-12.
The physician can examine and analyze the ECG according to what he needs.
27
Fig.6-12
Click "Gain" to adjust the wave's gain, viz. Amplification factor.
Click "single lead" to change the lead no. and display the ECG of appointed lead.
Click "SV" to display all the strip graph of the appointed kinds in the current ECG.
Prompt:
The strip graph is such a graph that it can plot a single lead ECG wave in a quadrate area and
mark the beginning time and average heart rate. The wave of 3.5s after the beginning time is the
main wave.
Pressing "Ctrl" key on the keyboard and clicking the left key of mouse on some a strip graph can
select it to change the attribute or delete. The background of the selected strip graph will turn
black. The same operation can also cancel the selection.
The following is the introduction taking example for "Max HR".
Click "Max HR" in the menu as Fig.6-12, and the strip graph of the max heart rate will appear(as Fig.6-
13), which is for the main analytical lead. Of course, the physician can choose other lead according to
the needs by button .
28
Name of strip graph Lead mark Number of strip graph
No. and starting time
Wave attribute
modification
Average HR
Fig.6-13
V: Change type to ventricular premature beat S: Change type to supra ventricular premature beat
N: Change type to normal beat L: Change type to long intermission
AF: Change type to atrial flutter Af: Change type to atrial fibrillation
VF: Change type to ventricular flutter Vf: Change type to ventricular fibrillation
O: Change type to interference X: Delete
In this interface, the software selects no1 strip graph as Max HR automatically. If you want to change
into other graph manually, click the right key of mouse on that graph and select "confirm MaxHR", then
this graph will be set as Max HR and changed into the no1 graph, following that, Max HR in the main
report will also change.
Attention: for Max HR, default 6 strip graphs are displayed. If all of that 6 graphs are interference waves
or false error, select a graph and delete it. Then the software will automatically analyse and get a new
Max HR strip graph and add to the display, as Fig.6-14.
Attention: it is similar between Min HR and Max HR in display and operation, so there will be no
extra introduction in the following content.
29
The X button has been

Enabled.
Fig.6-14
Click button, show the multi-lead ECG from the starting time(as Fig.6-15).
Fig.6-15
Attention: in the display interface of the strip graph, double click a graph with the left key of
mouse to switch it to the multi-lead cardiogram on the same time.
Click button, show the strip graph of supra ventricular electrocardiogram.
30
Fig.6-16
Click button, show the strip graph of ventricular electrocardiogram (as Fig.6-17).
Fig.6-17
Attention: the strip graph of and can be modified on attribute in the selected state,
while the strip graph of , and can only be deleted.
Click the button, enter ST elevation ECG analysis.
31
The physician can "choose lead" according to what he

needs to input the parameter. The parameter should be
between 0.01 and 0.3. If the input number is out of the
range, the computer will display:
Click "ok", and input the parameter again.
Select a lead and click "OK", and in the background window all of the STE strip graphs of this lead,as
Fig. 6-18.
Fig.6-18
Click button, display ST depression electrocardiogram.
32
The physician can "choose lead" according to what he

needs to input the parameter. The parameter should be
between 0.01 and 0.3. If the input number is out of the
range, the computer will display:
Click "ok", and input the parameter again.
Select a lead and click "OK", and in the background window all of the STE strip graphs of this lead,as
Fig. 6-19.
Fig.6-19
Click button, display other classified ECG: S Doublet, S bigeminal rhythm, S trigeminal rhythm,
S tachycardia; V tachycardia, V Doublet, V bigeminal rhythm, V trigeminal rhythm, RR Pause, atrial
flutter, atrial fibrillation, V flutter, V fibrillation, Max HR, Min HR.
Before above the classified ECG display operations, if refresh button (high bright) means the
data need refresh, click this button to refresh data.
Click button to display single lead ECG waveform or change the lead displayed in the strip graph.
Click button, display the Arrhythmia Table.

Arrhythmia Table A: display the arrhythmia statistic for every hour, as Fig.6-20.
33
Fig.6-20
HR : Average HR MinHR: minimum HR

MaxHR: maximum HR VE: ventricular premature beat
VEPair: ventricular pair VE Run: ventricular run
VE Big: ventricular bigeminy VE Trig: ventricular trigeminy
SVE: supra ventricular premature beat SVE Pair: supra ventricular pair
SVE Run: supra ventricular run SVE Big: supra ventricular bigeminy
SVE Trig: supra ventricular trigeminy L: long intermission
Double click any a data among the row of “HR” “MinHR”and“MaxHR”with the left key of mouse to
modify it, and click "OK" to save this modification.
Arrhythmia Table B:display the ST average voltage statistic of each lead for every hour, as Fig.6-21.
34
Fig.6-21
Double click any a data in the row from “V1_ST” to “V5_ST”with the left key of mouse to modify it,
and click "OK" to save this modification.
Click button, enter HRT analysis module.

HRT could be quantificationally expressed by two parameters, the two parameters are TO and TS.
Ventricular premature beat causes artery blood pressure brief foul-up. When the adjustable function is
natural, this transitory change will be represented by the form of HRT immediately; when the adjustable
function is injured, the change will weaken or disappear as Fig.6-22:
35
Fig.6-22
The position marked "HRT beginning" is the beginning position of wave that satisfies HRT judged
condition, the third QRS wave after this position is ventricular premature beat, you can see the RR
interphase trend graph in the whole HRT occurring term in the left below graph, which have signed the
TO, TS segment with red line to make the user more convenient to judge.
Click the button in toolbar will display the wave that satisfies last
HRT analysis condition, Click the button will display the wave that satisfies next HRT analysis
condition, click will display the HRT waveform after superposition on the left below window
graph as Fig.6-23:
Fig.6-23
The erect line on the dot express RR interphase the maximal value and minimal value on different period
of time.
The three row number below graph express the RR interphase the maximal value, the average and
minimal value for the corresponding dot.
The graph on the right below window is the conclusion as Fig.6-24:
36
Fig.6-24
Before seeing the whole case report, the option such as "Normal Beats" will show the word "Not Judge".
When the result is in the range that "Danger number" indicates, the corresponding result will turn to red
to remind the user.
Click button to enter the T Wave alternation analysis module.

T wave alternans (TWA) is a periodic beat-to-beat variation in the amplitude or shape of the T wave in
an electrocardiogram, and the variation of the amplitude is ≥ 0.1mV. TWA is a important index on
judging and preventing Arrhythmia.
The analysis adopts TWA measure basing on the maximum of T wave. The general method is:choose
continuous 8 (16, 32, ……128) waveforms, number QRS waveform from the first one, such as 1, 2,
3, ……, 8, then compare the maximum of T wave;if the difference of T wave is larger than the range
that has preestablished, there is TWA phenomena. After comparing, carry out superposition of the
singular number (1, 3, 5……) wave and superposition of dual number (2, 4, 6……) wave respectively,
then draw the result after superposition, it will be more obvious as Fig.6-25:
Fig.6-25
37
The position marked "TWA Start", "TWA end" is the section of wave that satisfies TWA judged
condition. On the left, it is the superposition graph of the singular number wave and dual number wave.
The green line is the superposition wave of the singular number, the red line is the superposition wave of
the dual number. If there are red words below wave, it means there is TWA phenomenon for this lead
(such as V5-lead on above picture) . The number express the height difference after superposition of
the singular number wave and superposition of dual number wave. Click the rectangle where the wave is,
the right wave graph will turn to single-lead wave of the appointed lead. "HR trend", "RR interphase
trend" above express the heart rate of TWA segment and the mutative trend of RR interphase.
Click button in toolbar will display the wave that satisfies last
TWA analysis condition, Click the button will display the wave that satisfies next TWA analysis
condition.
and express the switch between single lead and multi-lead for the current displaying
waves. is the setting button, click it, then the following dialog box will appear:
The user can set the TWA judging standard and the heart beat detecting number. The range for TWA
judging standard is 40-100µV, HB detecting number is:8-128.The purpose of setting is analysis
convenience and reducing mistake.
Click button to measure RR and PR interval.
Put the red target on the ECG,

pressing the left button and dragging
the red target, when there appears a
blue rectangle, release the mouse,
then the result of measure will turn
on.
Click button to modify the type of QRS wave.
38
Put the mouse pointer which has the

blue rectangle on the wave of QRS
that need to modify, then you can
click the left button to modify the
wave.
For example: put the blue rectangle on
the S that need to modify in the left
picture, click the left button and the S
will change to V, then continue click
the left button, you will get the O.
Under such situation, the waveform could be modified continuously. Move the mouse to the beginning
of the waveform which needs modification, click the right button to choose the start position, then move
to the end, click the right button again to make sure the end position. Now the segment can be modified.
Choose the start pos Choose the end pos Modify the waveform in series
Fig.6-26
It is similar to the interface of order replay, but add the azury diagram above the HR trend. It is the RR
39
interval of the current position that displayed. At the same time, there is a red rectangle appear on the
multi channel graph. The waveform that the red rectangle indicates corresponds to the waveform
indicated on the RR interval graph.
The user can choose any parts of RR interval to scan by using the HR trend at the bottom. User also can
click directly. Use the to roll forwards or backwards and use the to turn over the page.
During this process, the multi-channel graph and the green line on the HR trend will change at the same
time.
You will see that there are azury, navy blue, gray and some white lines on the RR interval graph. Their
meaning is as follows:
The azury is general waveform; The navy blue means the continuous S, V, AF, Af, VF, Vf ( the concrete
meaning see the template elucidation part) etc.; Gray means the continuous artefacts;The white lines
means interference segment.
System support keyboard to view RR interval trend graph. Click the view below, passing the " → "" ← "
can view the RR interval forward or backward, passing the " Page Up", "Page Down", can turn over the
page backward or forward, you can also pass the " ↑ " " ↓ "to play the RR interval automatically, and
press any key to stop playing.
The user can judge the atrial fibrillation occurrence time and length assumably by using RR interval
graph. Combining the multi channel graph, if make sure that the segment is AF; pop up the menu as
follows by clicking the right button on the RR interval: set "Start position" and "End position" to choose
a segment, then the segment turn red, its attribute can be modified to S Tachycardia, V Tachycardia,
Atrial flutter, Atrial fibrillation, Ventricle flutter, Ventricle fibrillation, Normal, interference. At the
same time, user also can choose automatic atrial fibrillation analysis ("AF analyse in segment") for this
segment. You also can choose the whole automatic atrial fibrillation analysis at the beginning ("AF
analyse in all").
Fig.6-27
40
Click button to store ECG of the current time in the print selective queue, as Fig.6-51
Click button to delet all of the manually selected ECG segment in the print queue
Click button to refresh data.
Click button, enter the HRV analysis module.
Notice: Click button, the system enters sinus beats HRV analysis. Which is the default
analysis. Click button below , the system analyse all beats HRV.
Click button, display normal beats HRV analysis results in 5 minutes .

The frequency domain, time domain and the integration electrocardiogram in 5 minutes. You can print
them, can change the starting time by clicking in the below trend graph, an change page by moving the
scroll bar in the top right window. As Fig.6-28.
Click button to display the all beats HRV analysis results in 5 minutes (as Fig.6-29).
Fig.6-28 Fig.6-29
Click button to display normal beats HRV analysis results in an hour.

The frequency domain, time domain and the integration electrocardiogram in one hour. You can print
them, can change the starting time by clicking in the below trend graph, an change page by moving the
scroll bar in the top right window (as Fig.6-30).
Click button to display the all beats HRV analysis results in an hour (as Fig.6-31).
41
Fig.6-30 Fig.6-31
Click button to display the normal RR interval histogram (as Fig.6-32).
Click button to display the all beats RR interval histogram (as Fig.6-33).
Fig.6-32 Fig.6-33
Click button to display the normal RR interval dispersion histogram (as Fig.6-34).
Click button to display the all RR interval dispersion histogram (as Fig.6-35).
Fig.6-34 Fig.6-35
Click button to display the normal RR interval poincare (as Fig.6-36).
Click button to display the all RR interval poincare (as Fig.6-37).
42
Fig.6-36 Fig.6-37
Click button to display the normal RR interval dispersion poincare (as Fig.6-38).
Click button to display the all RR interval dispersion poincare (as Fig.6-39).
Fig.6-38 Fig.6-39
Click button to display the normal frequence domain graph (as Fig.6-40).
Click button to display the all frequence domain graph (as Fig.6-41).
Fig.6-40 Fig.6-41
Click button to display the normal frequence domain 3D graph (as Fig.6-42).
Click button to display the all frequence domain 3D graph (as Fig.6-43).
43
Fig.6-42 Fig.6-43
Click button to display the whole process of the normal beats analysis compositive graphs (as
Fig.6-44).
Click button to display the all beats analysis compositive graphs (as Fig.6-45).
Fig.6-44 Fig.6-45
Click button to display the whole process of the normal beats HRV trend graph (as Fig.6-46).
Click button to display the all beats HRV trend graph (as Fig.6-47).
Fig.6-46 Fig.6-47
Click button, display the whole process of the normal beats HRV data table (as Fig.6-48).
Click button to display the all beats HRV data table(as Fig.6-49).
44
Fig.6-48 Fig.6-49
Click button to display the case report and additive analysis (as Fig.6-50).
Report edit window Sleep time setting
ST elevation and depression
Additive analysis
edit windo
Fig.6-50
 Report edit window:The window is used to modify the data of main report and fill in the
45
diagnostic conclusion.
Physician:Click the blank under "Physician" to put in the diagnostic conclusion manually or add
corresponding words from term library there.
Attention: The content under "Physician" will be printed in the report as diagnostic conclusion.
 Term library:A professional term library as diagnostic conclusion, where the terms can be added
and deleted.
Add: Click the inout frame, put in the term there and click "Add", the term can be added to the list
of term library.
Delete: Select a item in the list of term library and click "Delete" to delete it.
Copy: Select a item in the list of term library and click "Copy",the selected term will be added to
the diagnostic conclusion.
 Compute:The differences in statistic between report and fact may result from a lack of update for
the latest modify. Click "Compute" and "OK"to solve it.
 Print:Click"print" and "OK"to print the main report direct.
Attention: If a diagnostic conclusion has been written without clicking "OK" before "Compute"-
>"OK" operations, this conclusion will not be saved.
 Sleep time setting: Fill the factual time of sleep and wake to perform the dormancy asphyxia
analyse.
 Additive analysis edit window: edit the data in the Additive analysis report.
Attention: please fill in the sleep time according to factual situation to ensure the analyse accurate.
Click button to display the "Select Printing" window, where the physician can select the required
report to print.(as Fig.6-51).
Print selective ECG ECG to be printed Click the name of ECG to

display its wave
Switch wave's lead
46
Fig.6-51
Report: select"main report" to report.
STT Table: select "arrhythmia table B" in " sequential replay" to print.
Arrhythmia Table: select "arrhythmia table A" in " sequential replay" to print.
Flutter&Fib: select "Atrial Fibrillation"report to print.
STLE Table: select "STLE table" of a single lead to print.
Lead: select the lead whose "STLE table" to be printed.
HRV Table: select"HRV Table" to print.
Pacing Report: select"Pacing Report" to print.
HRV Trend: select "HRV Trend" to print, including: PNN50, SDANN, SDNN, MSD and rMSSD.
HRVgraph: select various graphs in the HRV analysis to print.
RR Bar: RR interval histogram;
RR DBar: RR interval dispersion histogram;
Poincar: RR interval poincare;
SDP: RR interval dispersion poincare;
FS: Frequence domain graph;
3DF: Frequence domain 3D graph.
Dormancy asphyxia analyse:select dormancy asphyxia analyse report to print, including: the reports of
trend, multiparameter balance and dangers analyse.
Trend: select various trend graphs to print, including: HR, ST of each lead, T of each lead, VE and SVE.
ECG segment selection:
Click button to remove the single time in the left frame into the right and wait to print.
Click button to remove all the time in the cleft frame into the right and wait to print.
Click button to remove the single time in the right frame into the left and cancel the print.
Click button to remove all the time in the right frame into the left and cancel the print.
All: select all items.
Inverse: cancel all of the items you have selected, and select all of the items you didn't select.
Default: select some primary reports.
OK: save this selection.
Cancel: cancel selection.
Attention:
Flutter&Fib is not selective to print in the lack of the Atrial Fibrillation analyse.
STLE Table is not selective to print in the lack of the STLE analyse.
HRV Table is not selective to print if it has not been examined in HRV analyse.
Pacing Report is selective to print only for the case with pacing.
47
Modify the name of the ECG segment in the selective print queue by double click it.
After clicking “OK”, click in the HRV analyse interface to print the report directly or click
to preview it.
Click button and enter the parameter setting operation (as Fig.6-52).
Fig.6-52
RR Pause: A standard of judging long interval module;
V Width Limit: A standart of judging ventricular premature beat module. A wave whose QRS complex
time is longer than this parameter will be judged to V. The default is 80ms;
SV Prematurity: A parameter of judging V or S;
Addition Precision: The precision of atrial fibrillation analyse;
Atrial Fibrillation: The report of atrial fibrillation analyse could be saved when this item has been set;
Pacing: The report of pacing analyse could be saved when this item has been set;
50Hz Filter: Using 50Hz Filter;
Smooth Display: Using Smooth Display;
Print type: Select a type for printing ECG waves;
Wave definition: Select a definition for printing ECG waves;
48
Page size: Select a papier-mache for printing;

Create report files: Create an electro-report after print;
Wireless Device Port: Select a wireless device port.
Notice: "Create report files" is unenabled in default of "Bullzip PDF Printer".
If the physician wants to analyse the case again, he can click the "OpenOldCase" in the menu of "File"
to open the following dialog box (as Fig.6-53).
Fig.6-53
Open the "Maintain" item in the "File", or click button on main toolbar, nter Case Manage as
Fig.6-54.
Click button to display the informations in turn;
Click button to modify an information that has been selected in case list;
Click button to delete the case which has been selected in case list;
Click button to review report files;

Double click the item to open the case.
Attention: when the cases are too many to display completely in the screen, a scroll bar will appear
at the right side of screen, drag it up and down to look over all cases.
49
Fig.6-54
Pacing analysis
When the data contain pacing signal, the system can identify it automatically and add the pacing analyse
function.
After recorder replay, the pace maker parameters setting window will appear, about its function, please
refer to "replay HOLTER recorder".
There are 11 templates windows in the template replay function, as Fig.6-55. One button is for a
template. The letters on the button is the name of its template(for example, D is Dual chamber pacing).
The percent on the button is the percentage of this kind of waves in total, and here nothing shows the
lack.
D:Dual chamber pacing AP:Atrial Pacing

AUS:Atrial Under Sense AOS: Atrial Over Sense
AOO:Atrial asynchronous pacing VP:Ventricular pacing
VUS:Ventricular Under Sense VOS:Ventricular Over Sense
VFB:Ventricular fusion beat VO:Ventricular Pseudofusion
VOO:Ventricular asynchronous pacing
Notice:The blue line under the ECG wave is marker for pacing, shows where is pacing signal on
the ECG wave.
50
Fig.6-55
Enter the order replay, click the button and appear the "Chart" dialog box which added the
"Pacemaker Table" (as Fig.6-58).
Fig.6-56
Sleep breath pause syndrome analysis
First, ake sure that the time when the patient begins to use recorder is setted correctly (as Fig.6-
51
57).
Fig.6-57
In case report please fill the correct sleep time and wake time about sleeping time segment as
Fig.6-58.
52
Fig.6-58
Last, in printing function dialog box , "Trend", multiparameter balance", dangers analysis" about
the option of "Dormancy asphyxia analyse" (as Fig.6-59).
Fig.6-59
After confirming, the physician could print dormancy asphyxia analysis report and diagnose.
53
Appendix Ⅰ Technical Specification
1.Scale voltage:1mV±5%
2.Standard Sensitivity:10mm/mV±5%
3.Noise level:≤30μV p-p
4.CMRR:≥60dB
5.Frequency response: 10Hz as benchmark, 0.5Hz～55Hz;-3dB
6.Time constant:Time constant≥3.2s
7.Scan speed:25mm/s±5%
8.Enduring polarization voltage:±300mV
9.Least measure signal:50 µV p-p
10.Interfere between channels:scan track deflexion (result from interfere between channels) ≤0.5mm
11.Product safety type:Type B (Internally powered)
12.Size:111mm (L) * 60mm (W) *25mm (H)
13.Net Weight: 105g (Without battery)
54

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TLC9803 Dynamic ECG Systems User Manual

The information contained in this document is subject to change without notice.

Chapter 1 Introduction ...............................................................................................................................

1.1 Environment condition

1.2 Product feature

1.4 Maintenance and cleaning

Chapter 2 Frame Character of Product

2.1 Sketch map for every orientation

Fig.2-1 Front view

Fig.2-3 Side view

Fig.2-4 Bottom view

2.2 Definition of keystoke, interface and indicator light

function key: marker/affirmance/choice

function key: menu/cancel/turn on/off

direction key: left

direction key: right

direction key: go down

Chapter 3 Preparing work before Using

3.1 Electrode placement

3.2 Battery installation and notice

indicates. Follow as Fig.3-2.

The batteries are full, the device could run in gear.

The batteries are insufficient, suggest not record.

Chapter 4 Recorder Operation Explanation

state time Battery State

Fig.4-1 Main interface

Use or to choose on main interface, press to enter new record operation,

Press to cancel recording and return to the main interface.

Use or to choose on main interface, press to enter review record operation

Lead state marker

to change the value.

4.3 System set

Press to enter the interface as shown in Fig.4-11.

Press to enter the initialization interface as shown in Fig.4-12.

Press to enter the time set interface as Fig.4-13.

interface displays the information as shown in Fig.4-14 if the connection is normal.

Chapter 5 Malfunction analysis and Troubleshooting

5.1 The problem related to the battery

Problem Cause Correction

1.The battery is used up. Change another battery.

5.2 The problem related to the skin and the electrode.

Problem Cause Correction

1. The skin can`t be cleaned well,

The wave is disturbed; the

3. The movement of the patient`s Ask the patient to avoid severe

The amplitude of some

Problem Cause Correction

Please check if the needles of the

3. The recorder is broken. Please contact our cmpany.

Connect the cable once again

5.4 Other problems

Problem Cause Correction

Chapter 6 Instructions for Analysis Software

3-lead wave in-phase

3 minutes RR interval trend graph

Represent: Arrhythmia analysis module, Template replay module,

Go to the previous operation go to the next operation.

Click into the template replay module (as Fig.6-8).

V: ventricular premature beat module AF: atrial flutter module