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Digital Electrocardiograph with Analysis

Kenz Cardico
PHYSICIANS CRITERIA GUIDE
Table of contents

Usage of Kenz Cardico ·························································································1


Introduction ·······································································································1
[Caution while using the ECG machine]·································································3

1. Outline of Automatic Analysis ······································································7


1-1 Procedure of Automatic Analysis ··································································7
1-2 Input of ECG (A/D conversion) ·····································································8
1-3 Digital Filter Treatment··············································································8
1-4 Sampling of Object ECG Wave for Analysis ····················································9
1-5 Waveform Measurement ·············································································9
1-6 Classification of Comments········································································ 13
1-7 Output of Analysis Results ········································································ 13

2. Report on the measurement precision of automatic········································ 14


measurement program·············································································· 14
2-1 Introduction ···························································································· 14
2-2 Standard databases to evaluate the accuracy of automated ECG····················· 14
measurements························································································· 14
2-3 Accuracy evaluation concerning amplitude measurement ······························ 15
2-4 Accuracy evaluation concerning wave durations measurement ······················· 15
2-5 Stability of measurements against NOISE··················································· 16

3. Report on the analysis and accuracy assessments of ······································ 17


automatic ECG analysis program······························································· 17
3-1 Purpose ·································································································· 17
3-2 Definition of accuracy measures for automated ECG interpretation················· 17
3-3 Accuracy of diagnostic interpretative statements ·········································· 18
3-4 Accuracy of rhythm interpretative statements·············································· 20

4. List of Analysis Results·············································································· 24


4-1 Output Format ························································································ 24
4-2 Others ···································································································· 25
4-3 Electrical Axis·························································································· 25
4-4 Hypertrophy···························································································· 26
4-5 Myocardiopathy······················································································· 26
4-6 Bundle-Branch Block················································································ 28
4-7 Atrioventricular Pathy·············································································· 29
4-8 Myocardial Infarction ··············································································· 29
4-9 Arrhythmia····························································································· 31

5. List of Comments ····················································································· 33


5-1 Comments for Input Waveform Condition···················································· 33
5-2 Comments for Analysis Observation or Measurements ·································· 33
5-3 Comments for Treatment Guide ································································· 34
6. Logic of Diagnosis····················································································· 37
6-1 Notation of Judgment Criteria ··································································· 37
6-2 Other comments ······················································································ 37
6-3 Comments on Electrical Axis······································································ 39
6-4 Comments on Hypertrophy········································································ 40
6-5 Myocardiopathy······················································································· 44
6-6 Bundle-Branch Block················································································ 47
6-7 Atrioventricular pathy ·············································································· 48
6-8 Myocardial Infarction ··············································································· 50
6-9 Arrhythmia····························································································· 53
6-10 Post-Exercise ECG Analysis ······································································ 57

7. Minnesota Code (except Cardico 302)··························································· 58


7-1 Notation of Classification··········································································· 58
7-2 Code 1 ···································································································· 59
7-3 Code 2 ···································································································· 61
7-4 Code 3 ···································································································· 62
7-5 Code 4 ···································································································· 63
7-6 Code 5 ···································································································· 63
7-7 Code 6 ···································································································· 65
7-8 Code 7 ···································································································· 65
7-9 Code 8 ···································································································· 66
7-10 Code 9···································································································· 67

8. Long-Term Mode (except Cardico 302) ························································· 68


8-1 Preface ··································································································· 68
8-2 Arrhythmia Analysis ················································································ 68
8-3 Examination of Autonomic Nervous System················································· 69
Usage of Kenz Cardico

The Kenz Cardico is used as diagnostic aid. However, the system is not intended to
replace the doctor’s expert review. For routine adult or child ECG analysis, particularly
when a cardiologist is not immediately available, and to aid in referring patients for
immediate follow-up, the Kenz Cardico can strongly assist physician for prompt
diagnosis. Also the Kenz Cardico can be used for pre-op ECG interpretations, especially
when an analysis is needed quickly. The system and its thoroughly evaluated programs
help to save physicians’ trace, measurements and analysis on the report. The exclusion
of the need or routine ECG measurement and the ability of the Kenz Cardico to analyze
normal tracings can be substantially reducing the workload of any ECG reporting
Service.

Introduction

Japanese research on auto diagnostic electrocardiography began about 30 years ago.


Devices have been in service for many years and are now in general use. One of the
numerous reasons for the broadened application of these devices is the computerized
analysis of electrocardiograms.

Advantages of Computerized Analysis:

1. Diagnostic Objectivity
In addition to a subjective diagnosis by a physician, objective data are obtained from
the instrument. Thus, data can easily be double-checked.

2. Diagnostic Reproducibility and Consistency.


Even among medical specialist, varied individual interpretations and changing
opinions are common. Auto diagnostics yields reproducible results through objective
measurement.

3. Diagnostic Efficiency.
The rapid processing made possible by auto diagnostics improves screening
efficiency. Patients diagnosed as abnormal can be identified more readily, allowing
the staff to concentrate on essential tasks.

4. Checking New Diagnostic Data.


Often desired results con not be derived by conventional means without complex
calculations, but with auto diagnostics even electrical axis and QTC data can be
readily derived.

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Though extremely important, computerized analysis is intended to assist in
formulating expert electrocardiography diagnosis and should be used only as a
reference. This is because there are still several problems connected with auto
diagnostic cardiograms, such as:

1. Diagnostic Consistency.
Exclusive analysis of healthy subjects will produce diagnoses with high probability.
Even when abnormalities are present, a diagnosis with 70 – 80% probability is
possible, depending on the type of analysis.

2. Reproducibility.
Although reproducibility of results is one of the advantages claimed for
computerized analysis, may or may not be produced for borderline
electrocardiograms, since comparisons are made numerically.

3. Pattern Recognition.
Humans have a strong capacity for pattern recognition, but complex calculations
and memorization are difficult for them. The opposite is true for computers;
computers are weak in discerning patterns.
Electrocardiograms are occasionally misread due to incorrect measurements
resulting from noise or drift caused by hums or electromyograms. Extremely small
waves may be inaccurately measured. It is therefore desirable to input the cleanest
possible data.

4. Diagnostic Standards.
Criteria differences may contribute to poor consistency with ECG interpretation by
a physician. The device should be used with an understanding of the difficulties
involved with those electrocardiograms which exceed auto diagnostic limitations.
The Kenz Cardico program is explained in the following sections. It is included to
provide through understanding of the machine’s strengths and weaknesses.

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[Caution while using the ECG machine]

We endeavored to improve the accuracy of ECG analysis, however, computerized


waveform diagnosis (pattern recognition) is insufficient when compare to expert’s
electrocardiographic diagnosis. Please understand the following precautions when
using the machine.

(1) Precaution regarding waveform measurement.


・ Muscle Tremor and HUM interference can cause wrong measurement for P-wave,
Q-wave and f-wave.
・ Baseline drift can cause misreading, overlook for ST, T-wave.
・ If the ending point of QRS-wave (S-wave) is smooth, there is a possibility that it
may cause wrong measurement. In this case, there is a tendency that it will lead
to wrong reading as Intraventricular Conduction Delay.
・ If the ending point of T-wave is smooth, there is a possibility that it may cause
wrong measurement. In this case, it can be misread as QT-prolong.
・ R-wave may not be detected due to Low voltage. In this case, it can cause
misanalysis for arrhythmia.
・ By recording with muscle filter switched ON, the size of P-wave will be reduced
and it can be the reason for misreading as Atrial Fibrillation.
・ The calculation of axis might not correct in low voltage.
・ If complicated arrhythmia overlap, P-wave can not be detected, it can be misread
as Atrial Fibrillation.

(2) Precaution regarding analysis program.


・ By using Minnesota Code alone for classification, many cases have been misread
and overlook, therefore, it is imperfect to use it clinically. For our analysis
program, in order to be used clinically, we have taken complication into
consideration and the program has been improved to a more realistic standard.
・ The Object age for analyzing pediatric ECG is between 0 and 18 years old.

(3) Comments due to poor consistency.


・ WPW syndrome without shortening of PR interval can not be analyzed.
・ When Supraventicular Premature Contraction present in the ECG with broad
QRS lack in sharpness likes that of Bundle Branch Block, it can be misjudged as
Ventricular Premature Contraction due to misrecognition of the ECG waveform.
・ Overlook of small r-wave or misread as S-wave or Q-wave can happen. In this
case, it will lead to suspicion of abnormal Q-wave or misread as Myocardial
Infarction. The tendency is obvious especially in chest leads (V1, V2).
・ When there is misread for Myocardial Infarction, in many cases it will be output
as [XXX infarction rejected] or [Abnormal Q?]
・ For III°Atrioventricular Block with R-R variation, the judgment is a mistake.
・ For II°and III°Atrioventricular Block, there are some cases whereby the P-wave
can not be detected completely and thus being overlooked.
・ Normally, Intermittent WPW Syndrome, Right Bundle Branch Block, Fusion Beat

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and others can not be analyzed. In most cases, there are being analyzed as
Ventricular Premature Contraction.
・ For arrhythmia, Bradycardia, Tachycardia, Premature Contraction, Atrial
Fibrillation, Sinus Arrhythmia, I°Atrio-ventricular Block and others have the
tendency toward the arrhythmia groups that are difficult for automatic analysis.
・ For arrhythmia whereby the R-R intervals changed slowly and little by little,
it may not be output as arrhythmia.
・ For Supraventricular Bigeminy whereby the coupling interval is not too short,
judgment is not possible.
・ If premature contraction occurs very frequently, there is a possibility that normal
heart rate can not be detected and heart rate of premature contraction will be
used in the analysis.
・ For Supraventricular Contraction that are blocked (no conduction), currently it
can not be analyzed.
・ For complicated arrhythmia, wrong judgment may occur.

Atrial Fibrillation.
・ For Atrial Fibrillation whereby the R-R interval is small (Tachycardia) or the
f-wave is small, the accuracy of detecting the f-wave will drop. Therefore, there is
a tendency that the analysis accuracy will drop.
・ If there is Atrial Fibrillation, due to the present of the f-wave, it can be misread as
Q-wave or ST-depression. When Atrial Fibrillation exist, and there is a
combination of diagnosis for Myocardial Infarction (abnormal Q), ST-T
abnormality, we recommend that the data to be checked once again.
・ For Atrial Flutter or Atrial Fibrillation with big f-wave, there is a tendency that it
will lead to wrong measurement of QRS-duration and misread as premature
contraction.
・ For Atrial Flutter with R-R interval variation, it will be analyzed as Atrial
Fibrillation.
・ For Atrial Fibrillation with tachycardia but low variation rate of R-R interval,
it may cause wrong judgment.

Parathythmia
・ Even an expert can hardly provide accurate analysis without recording a long
ECG for each lead, therefore, it can not be analyzed by the current analysis
program.

Paroxysmal Ventricular Tachycardia, Ventricular Fibrillation and Flutter,


etc.
・ If all the ECG leads show Tachycardia, it can not be analyzed by the current
analysis program.

Borderline ST-depression.
・ If ST-depression is less than 0.05mV (0.5mm), it does not meet the diagnosis
standard.

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Old Myocardial Infarction.
・ Around V1 to V3, if there is any small Q-wave (Width < 1mm, Depth < 1mm)
that does not meet the diagnosis standard, there will be no diagnosis of
Myocardial Infarction. However, in this case it is necessary to suspect the present
of old infarction.

Acute Myocardial Infarction


・ As Q-wave is used as an analysis standard for myocardial infarction, myocardial
infarction can not be analyzed at the initial stage of the acute infarction if Q-wave
is not present.
Change of ECG patterns with time in myocardial
The ECG patterns of Myocardial
Before infarction infarction change with time. (Refer to
the left diagram).

Hyper-acute period There is no abnormal Q-wave from


Hyper-acute period to acute period
Rise in T-wave (within a few hours after infarction).
As the values of ST-elevation and
Acute period
Q-wave are used as the judgment for
myocardial infarction, in this case,
ST elevation
there is no abnormal Q-wave,
Sub-acute period
therefore, myocardial infarction can
Appearance of not be analyzed.
Q-wave
The reason that not only the value of
ST-elevation but also the value of
Appearance of Q-wave are inputted as the necessary
inverted T-wave conditions for judgment of myocardial
infarction is because ST-elevation can
ST returns to the also present in a normal person.
Baseline level However, if [Chest Pain] information
Chronic period is inputted in the analysis condition of
Q-wave and
Patient Information, the judgment
Inverted T-wave
will not base on the present of
Q-wave.
In this case, only the value of
T-wave become
ST-elevation will be used to judge
normal again
whether it is within the range of acute
myocardial infarction.

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As explained above, please use the machine with the understanding of the strong point
and weak point of auto-analysis by a computer in order to help you in your diagnosis.

Please refer to the operation manual regarding the operation of the machine.

Notice:
In order to improve the accuracy of the analysis, please understand that the
content of this book may subject to change without given any prior notice.

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1. Outline of Automatic Analysis

1-1 Procedure of Automatic Analysis

Automatic analysis is preceded as following.

Power ON

Input of ECG (A/D Conversion)

Digital Filter treatment

Start

Sampling of object ECG waves for


analysis and print out the waves

Waveform Measurement
Auto-Analysis

Classification of comments

Output of analysis results

ECG Filing

Communication

z The above chart shows the general steps of automatic analysis. The steps are
z different depended on the ECG model, pre-set conditions of the recording mode,
etc.

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1-2 Input of ECG (A/D conversion)

z Cardico 1211, Cardico601


Sampling of ECG is done by A/D conversion at the frequency of 1,000 times/sec for
8 (I, II, V1, V2, V3, V4, V5, V6) of the 12 leads at the same phase, and at the
precision of about 2.44μV /bit. The other 4 leads (III, aVR, aVL, aVF) are calculated
by using the following formulas.

III = II – I
aVR = –(I+II)/2
aVL = I – II/2
aVF = II – I/2
Under these circumstances, A/D conversion is managed at the frequency of 10,000
times/second, so that sharp pulse signal like that of pacemaker pulse can be
sampled too.

z Cardico 302, Cardico 1210.


Sampling of ECG is done by A/D conversion at the frequency of 500 times/sec for 8
(II, III, V1, V2, V3, V4, V5, V6) of the 12 leads at the same phase, and at the
precision of about 5μV/bit. The other 4 leads (I, aVR, aVL, aVF) are calculated by
using the following formulas.

I = II – III
aVR = –(I+II)/2
aVL = I – II/2
aVF = II – I/2
Under these circumstances, A/D conversion is managed at the frequency of 4,000
times/second, so that sharp pulse signal like that of pacemaker pulse can be
sampled too.

1-3 Digital Filter Treatment

The sampled ECG data are then treated with digital filter to eliminate A/C noise
(HUM), baseline movement and muscle tremor that can cause interference to the
analysis. By this treatment, the waves dignity is refined, but please note that the
print-out, displayed ECG wave is about one second behind (filter delay) the real
signal induced from the patient (it can not be used as synchronize signal of
defibrillator, etc).

z HUM Filter (eliminate A/C noise)


It can be preset to ON/OFF.
Please adjust to (50/60 Hz) according to the frequency of the region where you
use the filter.
If the setting is not correct, the effectiveness of the filter will be reduced.

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z Drift filter (eliminate baseline movement)
It can be preset to ON/OFF.
As cut-off frequency is set to prevent distortion of the ST segment, etc.,
therefore, drastic baseline movement (body movement, etc.) may not be
eliminated completely.

z Muscle filter (eliminate muscle tremor).


It can be preset to (strong, weak)/OFF.
Please note that when muscle filter is used, the high frequency element of ECG
wave (QRS complex) will be reduced.

1-4 Sampling of Object ECG Wave for Analysis

When the recording begins, ECG waves are printed out, and at the same time the
waves are stored in the memory of the ECG machine. The sampling time of ECG
waves depends on the setting of the recording time.

1-5 Waveform Measurement

ECG wave measurement is done according to the following steps.

Detection of QRS complexes

Measurement of the parameter of each


template

Classification of QRS patterns

Determination of object ECG waves


for analysis

Measurement of object ECG wave

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(1) Detection of QRS complexes

z Cardico 1211, Cardico601


II lead and the automatic selected lead are used.

z Cardico 302, Cardico 1210,


Rhythm lead (II, V1) are used.
Please note that any artifact on either lead can affect the accuracy of QRS
detection.
In the case whereby ventricular premature contraction occurs frequently, and it
the amplitude different between VPC and normal beat is too big, normal beat
may not be detected.

(2) Measurement of the parameter of each template


Rhythm lead (II, V1) are used for the measurement of the below mentioned
parameters that are needed for QRS patterns classification or arrhythmia
analysis purpose.

P-wave, f-wave search


RR interval
QRS area
QRS amplitude

QRS duration PQ interval PP interval

(3) Classification of QRS patterns


The parameter values are determined from each template of the ECG wave, and
are classified into 3 types as following.
0 : Normal beat
1 : Normal ECG with shorten R-R interval, one beat before the abnormal
ECG beat.
2: Abnormal ECG beat.

0 1 2 0 0 1 1 0

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(4) Determination of object ECG waves for analysis
Determine the ECG wave for ECG analysis purpose.
Two methods, dominant and averaging methods, are available for ECG analysis
purpose. Either one can be selected.

z Dominant method
<In arrhythmia case>
ECG beat with the longest R-R interval is extracted from the “0” type of QRS
complexes.
In case “2” type of QRS complex is present, the ECG beat in front and behind the
“2” type QRS complexes are exempted from the object ECG wave.
If "0" type QRS complex is absent, the longest R-R interval of type "1"will be
extracted.
<Normal rhythm>
If only “0” type QRS complex is present, the 2nd beat will be extracted. If other
type, other then “0” type QRS complexes are present, the above method (as in
arrhythmia case) will be used.

z Averaging method
The mean value of “0” type QRS complex is calculated. In case there are too few
target heart beats, dominant method will be used for the analysis even if
averaging method is selected.

400mse 600mse As the one second data that is in front and behind the
R wave (standard point) as shown on the left diagram
are used for calculating the mean value, therefore, the
R wave (standard point) of the ECG beat that falls
within the following range will be excluded for the
mean value calculation even if it is belong to the “0”
type of QRS complex.

Exclusion region (400msec) Exclusion region (600msec)

Object region for analysis

※ If ventricular premature contraction (VPC) occurs frequently within the object


wave for analysis, it may result in using the VPC wave for the analysis.
Therefore, please reconfirm and make sure that there is no mistake.

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(5) Measurement of object ECG waves
1) The following items are measured from every 12 leads.
FDT (First Deflection Time)
The time begins from the starting point of QRS complex until the peak of R
wave.
a : amplitude
d : duration

QT interval

PQ interval QRS duration


FDT

R’a

-Pa +Ta
Qa Sa S’a
+Pa Ra -Ta

Qd Sd (ST measurement)
Rd

R’d S’d QT/10 QT/10

Basic point
(QRS starting point)
ST ST

STj:QRS ending
point

※ The isoelectric segment is not include in the QRS complex.

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2) Calculation of basic measurement values.
Hart Rate HR = 60 / R-R (sec) per minute
Dominant PR time (unit: second)
PR
The dominant value is designated from the PR intervals of 12 leads
Dominant QRS duration (unit: second)
QRS
The dominant value is designated from the QRS durations of 12 leads
Mean R-R interval (unit: second)
R-R
The mean value of all the R-R times
Dominant QT time (unit: second)
QT
The dominant value is designated from the QT intervals of 12 leads
Select from on of the following formulas
Bazett QTcB = QT / R–R
3
QTc Fridericia QTcF = QT / R–R
Framingham QTcL = QT+0.154×(1–R–R)
* In some models, Bazett formula is fixed.
QRS axis (unit: degree)

–1 3 (II + III)
AXIS = Tan
AXIS 2×I + II–III
However, I, II, III are the sum of QRS amplitude (Qa) + (Ra) + (Sa) +
(R’a) + (S’a) of each lead, respectively

1-6 Classification of Comments

Classification of comments is done according to the following steps.


Analysis of arrhythmia

Analysis of ECG waves

Determination of grade
Determine the propriety for stress test

Classification of comments

Classification of Minnesota codes

1-7 Output of Analysis Results

Display and print out the analysis results according to the preset conditions.

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2. Report on the measurement precision of automatic
measurement program

2-1 Introduction

It reports on the examination result as demanded by The International


Electrotechnical Commission (IEC) regarding the conformity for electrocardiograph
equipped with automatic measurement function.

2-2 Standard databases to evaluate the accuracy of automated ECG

measurements

Under clause 50.101.1 of 60601-2-51, it demanded the use of the following standard
database to evaluate the accuracy of electrocardiogram automated measurement.

1) Standard databases to evaluate the accuracy of amplitude measurements


Sixteen samples of CTS ECG Test Atlas (see IEC60601-2-51 table HH.1 of
appendix HH)

2) Standard databases to evaluate the accuracy of absolute interval and wave


duration measurements
Sixteen samples of CTS ECG Test Atlas (see IEC60601-2-51 table HH.1 of
appendix HH)

3) Standard databases to evaluate the accuracy of interval measurements on


biological ECGs
One hundred samples in CSE database (see IEC60601-2-51 table HH.2 appendix
HH)

4) Standard databases to evaluate the stability of measurements against NOISE


Thirty samples to make three types of the following noises superimposed to 10
samples in CSE database (see IEC60601-2-51 table HH.3 appendix HH)

Noise type
a) 25μV RMS high frequency muscle artifact noise
b) 50μV peak-to-valley 60Hz line frequency noise
c) 1mV peak-to-valley 0.3Hz sinusoidal base-line noise

- 14 -
2-3 Accuracy evaluation concerning amplitude measurement

The amplitude measurements of the P, Q, R, S, ST and T wave measured


automatically by using the standard databases which evaluated the precision of the
amplitude measurement as shown in ×××× passed the amplitude measurements
precision requirement as defined under clause 50.101.2 of IEC60601-2-51.

2-4 Accuracy evaluation concerning wave durations measurement

Each of the individual LEAD measurements (Q, R and S duration) measured from
the P, Q, R, S and T wave automatically by using the standard databases which
evaluated the precision of the wave duration measurements as shown in ××××, and
the global measurements (PR interval, QRS duration and QT interval), were within
the allowable range that was defined under IEC60601-2-51 clause 50.101.3.1 as
shown in the table 1. All the measurements passed the evaluation test. (Result of P
wave duration measurement is not shown here, as the P wave offset is not detected
by this program)
Table 1. Results of global intervals and Q-,R-,S-durations on calibration and analytical ECGs

Standard Acceptable Acceptable


Mean difference
Measurement deviation mean difference standard Pass/Fail
(msec)
(msec) (msec) deviation(msec)

PR-interval -4.0 0.8 ±10 8 Pass

QRS-duration 1.0 2.1 ±6 5 Pass

QT-interval -5.3 2.7 ±12 10 Pass

Q-duration -0.1 2.5 ±6 5 Pass

R-duration 0.7 3.0 ±6 5 Pass

S-duration 0.5 3.2 ±6 5 Pass

Each of the global measurements (PR interval, QRS duration and QT interval)
measured from the P, Q, R, S and T wave automatically by using the standard
databases which evaluated the precision of the wave duration measurements on
biological object shown in ×××× were within the allowable range defined under
IEC60601-2-51 clause 50.101.3.2 as shown in the table 2. All the measurements
passed the test.
(Result of P wave duration measurement is not shown here, as the P wave offset is
not detected by this program)

Table 2. Results of global measurements on CSE Biological ECGs

Standard Acceptable Acceptable


Mean difference
Measurement deviation mean difference standard Pass/Fail
(msec)
(msec) (msec) deviation(msec)

PR-interval 1.5 7.4 ±10 10 Pass

QRS-duration -4.5 5.7 ±10 10 Pass

QT-interval -7.0 11.9 ±25 30 Pass

- 15 -
2-5 Stability of measurements against NOISE
The results of global measurements (PR interval, QRS width and Q-T interval) for
the noise-free ECGs and the result of global measurements measured using the
method described in ×××× is compared by using the standard database which
evaluates the stability of the measurement against NOISE in accordance with
IEC60601-2-51 in the table 3.

Table 3. Disclosed changes of measurements caused by NOISE on ECGS

Disclosed differences
Global Type of added Standard
Measurement NOISE Mean
deviation
(msec)
(msec)
High frequency -7.5 12.0
PQ-interval Line frequency -3.8 4.9

Baseline -2.0 5.0

High frequency 11.3 14.8


QRS-duration Line frequency 5.0 4.7

Baseline -0.5 4.0

High frequency 0.0 9.6


QT-interval Line frequency -3.5 5.1

Baseline 1.0 9.0

- 16 -
3. Report on the analysis and accuracy assessments of
automatic ECG analysis program

3-1 Purpose

1) For diagnostic application(s) that the ELECTROCARDIOGRAPH is intended to


be used.
The purpose is to use for general population, ranging from cardiac abnormalities
of group examination to screening of the diagnosis.

2) Population(s) that ANALYSIS ELECTROCARDIOGRAPH is intended to be used.


Adult (Over 19 years old), Children (From 12 to 18 years old), infant (From 0 to
11 years old)

3) Location(s) where the ANALYSIS ELECTROCARDIOGRAPH is intended to be


used.
At general physicians’ offices, medical examination facilities and hospitals.

4) Emphasis of the accuracy of interpretation program in the ANALYSIS


ELECTROCARDIOGRAPH.
This program is well-balanced for its sensitivity and specificity. However, healthy
person may sometimes show abnormal electrocardiography pattern, and an
electrocardiogram sometimes show normal results even if heart disease is present
in the patient. Therefore, it is necessary to take other conditions and clinical
information into consideration in order to confirm the analysis results.

3-2 Definition of accuracy measures for automated ECG

interpretation

The following names are used to show the classification of the electrocardiogram.
TN(True normal) :a “Normal” correctly classified as “Normal”
FP(False pathologic) :a “Normal” incorrectly classified as “Pathologic”
FN(False normal) :a “Pathologic” incorrectly classified as “Normal”
TP(True pathologic) :a “Pathologic” correctly classified as “Pathologic”

- 17 -
Table1.Classification of test results
Classification
Reference
“Normal” “Pathologic”
“Normal” TN FP
“Pathologic” FN TP

Sensitivity:probability that a “True pathologic” would be classified as “Normal”


Sensitivity = TP/(TP+FN) × 100%

Specificity:probability that a “True normal” would be classified as “Normal”


Specificity = TN/(TN+FP) × 100%

Positive predictive value : probability that a classified “Pathologic” is a “True


pathologic”.
Positive predictive value = TP/(TP+FP) × 100%

3-3 Accuracy of diagnostic interpretative statements

Diagnostic interpretative statements are evaluated by using CSE diagnostic


database.
The CSE diagnostic database is decided from non-electrocardiogram source, which
consists of 1220 cases of effective clinical database.
The electrocardiogram of a healthy person was defined as ECG without a positive
cardiopulmonary disease based on comprehensive medical check-up (negative
medical history, normal physical examination and normal chest X ray) or invasive
cardiac study.
The electrocardiogram of a heart disease was defined as abnormal based on the
result of CATH、ECHO and the past medical history.
Diagnostic statements output from the analysis program were mapped to a common
set of pathologies, and the statements were confirmed by cardiologists. [Table 6]
Patient information of the CSE diagnostic database [Table 2] and the accuracy of the
diagnostic interpretative statements result [Table 3] were described.

Interpretations regarding non-specific ST-T abnormality and T-wave abnormality


are not reported for low rate of prevalence.

- 18 -
Table 2.Distribution of Age, Sex in CSE diagnostic database

race:european
sex
age ECGs
Male Female
0≦9 0 0 0
10≦19 6 3 9
20≦29 40 32 72
30≦39 85 52 137
40≦49 155 73 228
50≦59 254 100 354
60≦69 240 102 342
70≦79 46 26 72
80≦89 5 1 6
90≦99 0 0 0
100≦ 0 0 0
Total 831 389 1220

Table 3.Accuracy of diagnostic interpretative statements result


Number of Positive
Diagnostic ECGs tested Sensitivity Specificity predictive
category Rate % % value
n
% %
Normal 382 31.3 88.5 70.5 57.8
Left ventricular hypertrophy 183 15 47.0 98.0 80.8
Right ventricular hypertrophy 55 4.5 21.8 100.0 100.0
Biventricular hypertrophy 53 4.3 21.7 100.0 100.0
Anterior infarction 170 13.9 75.3 96.0 75.5
Inferior infarction 273 22.4 58.1 98.5 91.9
Combined Myocardial Infarction 73 6 61.0 97.4 60.1

- 19 -
3-4 Accuracy of rhythm interpretative statements

1862 samples of electrocardiograms were collected from two hospitals. These data
were used for the evaluation of the accuracy of rhythm diagnostic analysis.
Goal standard was defined by six cardiologists using 10 seconds of 12 lead
electrocardiogram.
Diagnostic statements output from the analysis program were mapped to a common
set of pathologies, and the statements were confirmed by cardiologists. [Table 6]
Patient information of the 1862 cases [Table 2] and the accuracy of the diagnostic
interpretative statements result [Table 3] were described.

Interpretations regarding idioventricular rhythm, escape beat and artificial


pacemaker rhythm are not reported for low rate of prevalence.

Table 4.Distribution of Age, Sex in 1862 cases

race:Japanese & European


sex
age ECGs
Male Female
0≦9 0 2 2
10≦19 8 10 18
20≦29 57 50 107
30≦39 117 70 187
40≦49 240 107 347
50≦59 349 147 496
60≦69 348 151 499
70≦79 95 75 170
80≦89 15 18 33
90≦99 3 0 3
100≦ 0 0 0
total 1232 630 1862

- 20 -
Table 5.Accuracy of rhythm interpretative statements result
Number of Positive
Specifici
ECGs tested Sensitivity predictive
Rhythm category ty
Rate % value
n %
% %
Normal Sinus Rhythm 1404 75.4 92.3 98.2 92.3
Atrial fibrillation and Atrial
110 5.9 98.2 99.6 93.9
flutter
Left Bundle Branch block 16 0.8 87.5 99.4 56.0
Right Bundle Branch block 103 5.5 86.4 99.5 90.8
Intraventricular block 18 0.9 27.8 99.8 55.6
Pre excitation 19 1.0 47.4 99.5 50.0
A-V block 97 5.2 80.4 98.9 80.4
Supraventricular arrhythmia 46 2.4 71.7 99.5 78.6
Ventricular arrhythmia 67 3.5 92.5 99.2 81.6
Sinus arrhythmia 75 4.0 94.7 99.4 86.6
Sinus tachycardia 53 2.8 94.3 99.7 89.3
Sinus bradycardia 92 4.9 95.7 98.6 79.3

Table 6.Mapping Table


SUZUKEN
SUZUKEN TEST Diagnostic category
CODE
807 Normal Sinus Rhythm Normal Sinus Rhythm
310 Left ventricular high voltage
Left Ventricular
311 Left ventricular hypertrophy ?
Hypertrophy
312 Left ventricular hypertrophy
321 Right ventricular hypertrophy ? Right Ventricular
322 Right ventricular hypertrophy Hypertrophy
330 Biventricular hypertrophy ?
Biventricular Hypertrophy
331 Biventricular hypertrophy
713 Cannot rule out anterior infarction
714 Cannot rule out lateral infarction
722 Anteroseptal infarction ?
723 Anterior infarction ?
724 Lateral infarction ?
Anterior Myocardial
732 Anteroseptal infarction
Infarction
733 Anterior infarction
734 Lateral infarction
742 Acute anteroseptal infarction ?
743 Acute anterior infarction ?
744 Acute lateral infarction ?

- 21 -
SUZUKEN
SUZUKEN TEST Diagnostic category
CODE
715 Cannot rule out inferior infarction
721 High-Post infarction ?
725 Inferior infarction ? Inferior Myocardial
731 High-Post infarction Infarction
735 Inferior infarction
745 Acute inferior infarction ?
Anterior Myocardial Infarction and Combined Myocardial
Inferior Myocardial Infarction Infarction
511 Left anterior hemi block
512 Left posterior hemi block Left Bundle Branch block
513 Complete left B B B
501 RSR' pattern
521 Complete right B B B
520 Incomplete right B B B Right Bundle Branch block
530 Bifascicular B B B
540 Trifascicular B B B ?
502 Intraventricular block
Intraventricular block
804 Idioventricular rhythm
601 Short PR
602 WPW ?
Pre excitation
603 WPW syndrome ( A type )
604 WPW syndrome ( B type )
611 A-V block I°
612 A-V block II°( Wenckebach )
613 A-V block II°( Mobitz )
A-V block
614 A-V block II°( 2:1 )
615 Complete A-V block ?
616 Complete A-V block
801 Left atrial rhythm ?
802 A-V junctional rhythm
803 Coronary sinus rhythm
814 Supraventricular tachycardia ?
851 Supraventricular premature contraction Supraventricular
852 Frequent SVPC arrhythmia
853 SVPC trigeminy
854 SVPC bigeminy
855 SVPC couplet
856 Runs of SVPC

- 22 -
SUZUKEN
SUZUKEN TEST Diagnostic category
CODE
815 Ventricular tachycardia ?
840 Aberrant conduction or VPC
841 Ventricular premature contraction
842 Frequent VPC
843 VPC trigeminy
Ventricular arrhythmia
844 VPC bigeminy
845 VPC couplet
846 Runs of VPC
847 VPC multifocal
848 VPC ( noise? )
830 Atrial fibrillation ?
831 Atrial fibrillation ( Brady )
832 Atrial fibrillation
833 Atrial fibrillation ( Tachy ) Atrial fibrillation and
834 Atrial flutter ( Brady ) Atrial flutter
835 Atrial flutter
836 Atrial flutter ( Tachy )
871 Sinus arrhythmia
sinus arrhymia
872 Sino-Atrial block
811 Tachycardia
812 Sinus tachycardia Sinus tachycardia
813 Extreme tachycardia
821 Bradycardia
822 Sinus bradycardia Sinus bradycardia
823 Extreme bradycardia

- 23 -
4. List of Analysis Results
4-1 Output Format

Observation Grade Judgment


Analysis Category Page
Code Comment for Stress Test

Observation Code : Observation codes are described in 3 digits.

1xx : Other
2xx : Electrical Axis
3xx : Hypertrophy
4xx : Myocardiopathy
5xx : Bundle-Branch Block
6xx : Atrioventricular Pathy
7xx : Myocardial Infarction
8xx : Arrhythmia

Analysis Category : Analysis Categories are subjected to changes in the up-graded


software.

Grade Judgment : Observation is divided into 4 grades.


In case multiple analysis categories are output, the highest
grade will be output as the final grade judgment.
However, this grade is classified under auto-diagnosis, but not
an indicator of serious illness for the clinical diagnosis.

Grade NORMAL ECG


BORDERLINE NORMAL
BORDERLINE ABNORMAL
ABNORMAL ECG
High

Comment of Stress Test : Observation is divided into 3 grades.


In case multiple analysis categories are output, the
highest grade will be output as the final grade judgment.
However, this grade is classified under auto-diagnosis, but
not an indicator of serious illness for the clinical diagnosis.

Grade
YES
YES (CAUTION)
NO
High

- 24 -
4-2 Others

BORDERLINE NORMAL
111 Low voltage (limb leads) 37
YES
BORDERLINE NORMAL
112 Low voltage (chest leads) 37
YES
BORDERLINE NORMAL
120 ST elevation 38
YES
NORMAL ECG
141 Counterclockwise rotation 38
YES
BORDERLINE NORMAL
142 Clockwise rotation 38
YES
BORDERLINE NORMAL
150 Very large T-wave 38
YES
BORDERLINE ABNORMAL
161 Dextracardia ? 38
YES (CAUTION)
No judgment
162 Arm leads reversed ? 38
No judgment
BORDERLINE ABNORMAL
171 QT prolongation 38
YES (CAUTION)

4-3 Electrical Axis

BORDERLINE NORMAL
201 Indeterminate axis 39
YES
BORDERLINE NORMAL
210 Mild left axis deviation 39
YES
BORDERLINE ABNORMAL
211 Left axis deviation 39
YES (CAUTION)
BORDERLINE ABNORMAL
221 Right axis deviation 39
YES (CAUTION)
BORDERLINE ABNORMAL
222 Marked right axis deviation 40
YES (CAUTION)
BORDERLINE ABNORMAL
223 S1 S2 S3 pattern 40
YES (CAUTION)

- 25 -
4-4 Hypertrophy

BORDERLINE NORMAL
301 Left atrial enlargement 40
YES
BORDERLINE NORMAL
302 Right atrial enlargement 41
YES
BORDERLINE NORMAL
310 Left ventricular high voltage 40
YES
BORDERLINE NORMAL
311 Left ventricular hypertrophy ? 43
YES
BORDERLINE ABNORMAL 40
312 Left ventricular hypertrophy
YES (CAUTION) 43
BORDERLINE NORMAL 41
321 Right ventricular hypertrophy ?
YES 43
BORDERLINE ABNORMAL 41
322 Right ventricular hypertrophy
YES (CAUTION) 43
BORDERLINE NORMAL
330 Biventricular hypertrophy ? 44
YES
BORDERLINE ABNORMAL
331 Biventricular hypertrophy 43
YES (CAUTION)

4-5 Myocardiopathy

BORDERLINE ABNORMAL
403 Flat T (Ant) 46
YES (CAUTION)
BORDERLINE ABNORMAL
413 Negative T (Ant) 46
YES (CAUTION)
BORDERLINE ABNORMAL
423 Mild ST-T abnormality (Ant) 45
YES (CAUTION)
ABNORMAL ECG
433 ST-T abnormality (Ant) 45
NO
ABNORMAL ECG
443 Marked ST-T abnormality (Ant) 44
NO
BORDERLINE ABNORMAL
404 Flat T (Lat) 46
YES (CAUTION)
BORDERLINE ABNORMAL
414 Negative T (Lat) 46
YES (CAUTION)
BORDERLINE ABNORMAL
424 Mild ST-T abnormality (Lat) 46
YES (CAUTION)
ABNORMAL ECG
434 ST-T abnormality (Lat) 45
NO

- 26 -
ABNORMAL ECG
444 Marked ST-T abnormality (Lat) 44
NO
BORDERLINE ABNORMAL
405 Flat T (Inf) 46
YES (CAUTION)
BORDERLINE ABNORMAL
415 Negative T (Inf) 46
YES (CAUTION)
BORDERLINE ABNORMAL
425 Mild ST-T abnormality (Inf) 46
YES (CAUTION)
ABNORMAL ECG
435 ST-T abnormality (Inf) 45
NO
ABNORMAL ECG
445 Marked ST-T abnormality (Inf) 44
NO
BORDERLINE ABNORMAL
406 Flat T (Ant, Lat) 46
YES (CAUTION)
BORDERLINE ABNORMAL
416 Negative T (Ant, Lat) 46
YES (CAUTION)
BORDERLINE ABNORMAL 45
426 Mild ST-T abnormality (Ant, Lat)
YES (CAUTION) 46
ABNORMAL ECG
436 ST-T abnormality (Ant, Lat) 45
NO
Marked ST-T abnormality (Ant, ABNORMAL ECG
446 44
Lat) NO
BORDERLINE ABNORMAL
407 Flat T (Ant, Inf) 46
YES (CAUTION)
BORDERLINE ABNORMAL
417 Negative T (Ant, Inf) 46
YES (CAUTION)
BORDERLINE ABNORMAL 45
427 Mild ST-T abnormality (Ant, Inf)
YES (CAUTION) 46
ABNORMAL ECG
437 ST-T abnormality (Ant, Inf) 45
NO
Marked ST-T abnormality (Ant, ABNORMAL ECG
447 44
Inf) NO
BORDERLINE ABNORMAL
408 Flat T (Lat, Inf) 46
YES (CAUTION)
BORDERLINE ABNORMAL
418 Negative T (Lat, Inf) 46
YES (CAUTION)
BORDERLINE ABNORMAL
428 Mild ST-T abnormality (Lat, Inf) 46
YES (CAUTION)
ABNORMAL ECG
438 ST-T abnormality (Lat, Inf) 45
NO
ABNORMAL ECG
448 Marked ST-T abnormality (Lat, Inf) 44
NO

- 27 -
BORDERLINE ABNORMAL
409 Flat T (wide range) 46
YES (CAUTION)
BORDERLINE ABNORMAL
419 Negative T (wide range) 46
YES (CAUTION)
Mild ST-T abnormality (wide ABNORMAL ECG 45
429
range) NO 46
ABNORMAL ECG
439 ST-T abnormality (wide range) 45
NO
Marked ST-T abnormality (wide ABNORMAL ECG
449 44
range) NO

4-6 Bundle-Branch Block

NORMAL ECG
501 RSR’ pattern 48
YES
BORDERLINE ABNORMAL
502 Intraventricular block 47
YES (CAUTION)
BORDERLINE ABNORMAL
511 Left anterior hemi block 47
YES (CAUTION)
BORDERLINE ABNORMAL
512 Left posterior hemi block 48
YES (CAUTION)
ABNORMAL ECG
513 Complete left B B B 47
NO
BORDERLINE NORMAL
520 Incomplete right B B B 47
YES
BORDERLINE ABNORMAL
521 Complete right B B B 47
YES (CAUTION)
ABNORMAL ECG
530 Bifascicular B B B 48
NO
ABNORMAL ECG
540 Trifascicular B B B 48
NO
BORDERLINE ABNORMAL
551 Mild ST elevation (Coved Type) 48
YES (CAUTION)
BORDERLINE ABNORMAL
552 ST elevation (Saddleback Type) 48
YES (CAUTION)
ABNORMAL ECG
553 ST elevation (Coved Type) 48
NO

- 28 -
4-7 Atrioventricular Pathy

BORDERLINE NORMAL
601 Short PR 49
YES
BORDERLINE ABNORMAL
602 WPW ? 49
YES (CAUTION)
ABNORMAL ECG
603 WPW syndrome (type A) 48
NO
ABNORMAL ECG
604 WPW syndrome (type B) 49
NO
BORDERLINE ABNORMAL
611 A-V block I° 49
YES (CAUTION)
BORDERLINE ABNORMAL
612 A-V block II°(Wenckebach) 49
YES (CAUTION)
ABNORMAL ECG
613 A-V block II°(Mobitz) 49
NO
ABNORMAL ECG
614 A-V block II°(2:1) 49
NO
BORDERLINE ABNORMAL
615 Complete A-V block ? 49
YES (CAUTION)
ABNORMAL ECG
616 Complete A-V block 49
NO
Artificial pacemaker rhythm ABNORMAL ECG
620 49
(noise?) NO
ABNORMAL ECG
621 Artificial pacemaker rhythm 49
NO

4-8 Myocardial Infarction


BORDERLINE ABNORMAL
701 Poor R progression 52
YES (CAUTION)
BORDERLINE ABNORMAL
702 Abnormal Q ? 53
YES (CAUTION)
BORDERLINE ABNORMAL
703 Abnormal Q 53
YES (CAUTION)
Cannot rule out anteroseptal ABNORMAL ECG
712 51
infarction NO
ABNORMAL ECG
722 Anteroseptal infarction ? 51
NO
ABNORMAL ECG
732 Anteroseptal infarction 51
NO
ABNORMAL ECG
742 Acute anteroseptal infarction ? 51
NO

- 29 -
ABNORMAL ECG
713 Cannot rule out anterior infarction 51
NO
ABNORMAL ECG
723 Anterior infarction ? 51
NO
ABNORMAL ECG
733 Anterior infarction 51
NO
ABNORMAL ECG
743 Acute anterior infarction ? 51
NO
ABNORMAL ECG
714 Cannot rule out lateral infarction 51
NO
ABNORMAL ECG
724 Lateral infarction ? 51
NO
ABNORMAL ECG
734 Lateral infarction 51
NO
ABNORMAL ECG
744 Acute lateral infarction ? 51
NO
ABNORMAL ECG
715 Cannot rule out inferior infarction 50
NO
ABNORMAL ECG
725 Inferior infarction ? 50
NO
ABNORMAL ECG
735 Inferior infarction 50
NO
ABNORMAL ECG
745 Acute inferior infarction ? 50
NO
ABNORMAL ECG
721 High-Post infarction ? 52
NO
ABNORMAL ECG
731 High-Post infarction 52
NO
ABNORMAL ECG
751 ST elevation (Rule out Acute M.I) 52
NO
ABNORMAL ECG
752 High T (Rule out Acute M.I) 52
NO

- 30 -
4-9 Arrhythmia

BORDERLINE NORMAL
801 Left atrial rhythm ? 53
YES
BORDERLINE NORMAL
802 A-V junctional rhythm 53
YES
ABNORMAL ECG
804 Idioventricular rhythm 53
NO
ABNORMAL ECG
805 Rule out digitalis intoxication
NO
NORMAL ECG
806 Sinus rhythm 56
YES
NORMAL ECG
807 Normal sinus rhythm 56
YES
BORDERLINE ABNORMAL
811 Tachycardia 54
YES (CAUTION)
NORMAL ECG
812 Sinus tachycardia 54
YES
ABNORMAL ECG
813 Extreme tachycardia 54
NO
ABNORMAL ECG
814 Supraventricular tachycardia ? 53
NO
ABNORMAL ECG
815 Ventricular tachycardia ? 54
NO
BORDERLINE ABNORMAL
821 Bradycardia 54
YES (CAUTION)
NORMAL ECG
822 Sinus bradycardia 54
YES
ABNORMAL ECG
823 Extreme bradycardia 54
NO
ABNORMAL ECG
830 Atrial fibrillation ? 54
NO
ABNORMAL ECG
831 Atrial fibrillation (Brady) 54
NO
ABNORMAL ECG
832 Atrial fibrillation 54
NO
ABNORMAL ECG
833 Atrial fibrillation (Tachy) 54
NO
ABNORMAL ECG
834 Atrial flutter (Brady) 55
NO
ABNORMAL ECG
835 Atrial flutter 54
NO

- 31 -
ABNORMAL ECG
836 Atrial flutter(Tachy) 55
NO
ABNORMAL ECG
840 Aberrant conduction or VPC 55
NO
BORDERLINE ABNORMAL
841 Ventricular premature contraction 55
YES (CAUTION)
ABNORMAL ECG
842 Frequent VPC 55
NO
ABNORMAL ECG
843 VPC trigeminy 55
NO
ABNORMAL ECG
844 VPC bigeminy 55
NO
ABNORMAL ECG
845 VPC couplet 55
NO
ABNORMAL ECG
846 Runs of VPC 55
NO
ABNORMAL ECG
847 VPC multifocal 55
NO
BORDERLINE ABNORMAL
848 VPC (Noise?) 55
YES (CAUTION)
Supraventricular premature BORDERLINE ABNORMAL
851 55
contraction YES (CAUTION)
ABNORMAL ECG
852 Frequent SVPC 56
NO
ABNORMAL ECG
853 SVPC trigeminy 56
NO
ABNORMAL ECG
854 SVPC bigeminy 56
NO
ABNORMAL ECG
855 SVPC couplet 55
NO
ABNORMAL ECG
856 Runs of SVPC 55
NO
BORDERLINE ABNORMAL
861 Escape beat 56
YES (CAUTION)
NORMAL ECG
871 Sinus arrhythmia 56
YES
ABNORMAL ECG
872 Sino-Atrial block 56
NO
ABNORMAL ECG
880 Unclassified arrhythmia 56
NO

- 32 -
5. List of Comments
5-1 Comments for Input Waveform Condition

These messages are output when the dominant waveforms are irregular.

Analysis impossible due to unrecognizable input.


Any lead off ?
(Limb leads, V2) Applicable lead is Printed out.
Noise or baseline drift is present.
(Limb leads, V1, V2, V3, V4, V5, V6)) Applicable lead is Printed out.

5-2 Comments for Analysis Observation or Measurements

These message are output when the analysis observation or measurement is


doubtful.

Check electrodes. Re-recording is recommended.

Check for any measurement error.

Muscle filter may reduce QRS amplitude.

Check if any small r-wave is overlooked.

Check ST-T change by f-wave.

Check abnormal Q-wave.

Check if respiratory pulse is analyzed as SVPC.

Check if VPC or not.

P-wave is unclear. Check P-wave.

- 33 -
5-3 Comments for Treatment Guide

These comments are output according to the analysis observation. (Output of


comments can be switched off).
In case there are many analysis comments, the most important comments is
output.

Following message is output if the analysis observation is normal.

Virtually within normal limits.

Following message is output if the analysis observation is borderline normal.

Can leave the patient as he/she is if there is no symptom nor underlying disease.

Following message is output if the analysis observation is borderline abnormal.

Observe progress if there is no symptom nor underlying disease.

Following message is output if the analysis observation is cardial infarction.

Check subjective symptoms such as chest pain.


Consultation with cardiologist is recommended.

Following message is output if the analysis observation is WPW.

Pay attention as paroxysmal tachycardia is suspected.


HOLTER ECG or other examinations are recommended.

Following message is output if the analysis observation is Bundle-Branch Block.

Pay attention as myocardial ischemia, cardiac hypertrophy, etc., are suspected.


HOLTER ECG or other exam are recommended.

Following message is output if the analysis observation is complete Left BBB or


complete Right BBB.

Evaluate on the underlying disease.

Following message is output if the analysis observation is Left anterior hemi block
or Left posterior hemi block.

Cardiac hypertrophy or myocardial infarction, etc., are suspected.


Evaluate on the underlying disease.

Following message is output if the analysis observation is left atrial enlargement.

Mitral valve disease or aortic valve disease, etc., are suspected.


Evaluate on the underlying disease.

- 34 -
Following message is output if the analysis observation is right atrial enlargement
or right ventricular hypertrophy.

Chronic pulmonary disease or congenital heart disease, etc., are suspected.


Evaluate on the underlying disease.
Following message is output if the analysis observation is left ventricular
hypertrophy.
Hypertension, cardiomyopathy or aortic valve disease, etc., are suspected.
Evaluate on the underlying disease.
Following message is output if the analysis observation is left ventricular
hypertrophy (left atrial enlargement) and right ventricular hypertrophy (right atrial
enlargement).
Cardiac hypertrophy is suspected. Chest X-Ray, echocardiogram, etc., are
recommended to evaluate the underlying disease.

Following message is output if the analysis observation is digitalis information,


atrial block or VPC (frequent, couplet, bigeminy, trigeminy, runs).

Check up Digitalis Intoxication ?

Following message is output if the analysis observation is atrial fibrillation or atrial


flutter.

Anti-arrhythmia drugs or digitalis are recommended in case of extreme tachycardia


or congestive heart failure.

Following message is output if the analysis observation is VPC (frequent, couplet,


bigeminy, trigeminy or runs).

HOLTER ECG or other examinations are recommended to evaluate the underlying


disease or vent. tachycardia, etc.

Following message is output if the analysis observation is sino-atrial block,


idioventricular rhythm, escape beat or extreme tachycardia.

Sick sinus syndrome is suspected.


FOLTER ECG or other examinations are recommended.

Following message is output if the analysis observation is A-V block II°(Mobitz),


A-V Block II°(2:1), Trifascicular BBB? or Bifascicular BBB.

These ECG findings may develop complete AV block. Holter ECG or other
examination are recommended.

- 35 -
Following message is output if the analysis observation is complete A-V block III°.

Heart failure, Adams-Stokes syndrome, etc. may occur. Consultation with


cardiologist is recommended.

Following message is output if the analysis observation is Sinus tachycardia or


Extreme tachycardia (Wenckebach).

Anemia, hyperthyroidism heart disease, etc. are suspected.


Evaluate on the underlying disease.
Following message is output if the analysis observation is A-V block II°
(Wenckebach).
HOLTER ECG or other examinations are recommended to rule out the organic heart
disease.

Following message is output if the analysis observation is VPC (frequent, couplet,


bigeminy, trigeminy, runs or supraventricular tachycardia ?).

HOLTER ECG or other examinations are recommended to observe progress.

Follwing message is output if the analysis observation is Mild ST elevation.

Abnormal ECG. Further examination and consultation with a physician specialized


in arrhythmia are necessary.

Follwing message is output if the analysis observation is ST elevation (Saddleback


Type) or Mild ST elevation (Coved Type).

Abnormal ECG. Further examination is necessary. Recommended to consult with a


physician specialized in arrhythmia.

- 36 -
6. Logic of Diagnosis
6-1 Notation of Judgment Criteria

1. Classification of age and sex.


(1) In case the criteria are different due to different age groups, the following
descriptions will be made.
e.g.) Representative QRS with ≧ 0.12 (0.11/0.10) sec.
0.12 sec ・・・・・・・・・・・・・・・・ Criteria for age 19 years and above.
0.11 sec ・・・・・・・・・・・・・・・・ Criteria for age between 12 and 18 years.
0.10 sec ・・・・・・・・・・・・・・・・ Criteria for age between 0 and 11 years.

(2) Without inputting age and sex.


If age of patient is not input, the patient’s age will be treated as 30 years.
If sex of patient is not input, the patient’s sex will be treated as male.

2. Pediatric diagnosis theory


If the age 18 years or under is input, pediatric diagnosis theory will be applied.
Besides the differences in the criteria, some parts of the analysis are based on
different theory.
In that case, the description [Under 18 years] will appear.

3. Unit of criteria
(1) Time duration ・・・・・・・・・・・・・ second
(2) Voltage (Amplitude) ・・・・・・・ mV

4. Phrases
(1) Sum of T amplitude ・・・・・・・ (+Ta) + (–Ta)
(2) Positive deflection ・・・・・・・・・ (Qa) + (Ra) + (Sa) + (R’a) + (S’a) is positive
(3) QRS amplitude ・・・・・・・・・・・ Peak to peak of QRS complex
(4) Qa ・・・・・・・・・・・・・・・・・・・・・・・・・ Amplitude of Q wave (a : amplitude)

6-2 Other comments

・ Rejected if related to WPW syndrome or complete left BBB

Analysis category Judgment criteria


Low voltage (limb
QRS amplitude is less than 0.5mV in all the limb leads.
lead)
Low voltage (chest
QRS amplitude is less than 1.0mV in all the chest leads.
lead)

- 37 -
Analysis category Judgment criteria
If it meets any of the following conditions, and rejected if
ST elevation
related to myocardiac infarction.
1) ST elevation > 0.2mV in at least two of the following
leads (I, II, aVL, aVF).
2) ST elevation > 0.5mV in at least two of the following
leads (V1, V2, V3).
3) ST elevation > 0.3mV in at least two of the following
leads (V4, V5, V6).

[Under 18 years]
1) ST elevation > 0.2mV in any of the following lead
(I, II, aVL, aVF).
2) ST elevation > 0.5mV in any of the following leads
(V1, V2, V3).
3) ST elevation > 0.3mV in any of the following leads
(V4, V5, V6).
Counterclockwise R-wave is equal to or greater than S-wave in lead V2, and
rotation provided that there is no myocardial infarction, right
ventricular hypertrophy, and intraventricular block.

Clockwise rotation R-wave is smaller or equal to S-wave in lead V5, and


provided that there is no myocardial infarction, right
ventricular hypertrophy, and intraventricular block.

T-wave > 1.5mV in at least two leads, excluding lead aVR,


Very large T-wave
and provided that there is not myocardial infarction.

[Under 18 years]
T-wave > 1.2mV in at least two of the following leads
(I, II, III, aVL, aVF, V5, V6).

Dextracardia ? Negative P, QRS, T-wave in lead I, QRS < 1.0 mV in either


lead V5 or V6.

Arm leads reversed ? Negative P, QRS, T-wave in lead I.

QT prolongation QTC is equal to 0.49 second or greater, and heart rate is less
than 80. Provided that there is no complete right BBB.

- 38 -
6-3 Comments on Electrical Axis

・ Rejected if related to WPW syndrome, complete left BBB, low voltage (limb) or
inferior myocardial infarction.
-90°

S1S2S3 pattern Left axis deviation


-150° -30°

Mild left axis deviation

Marked right axis deviation 0°

Normal

+120°

+90°
Right axis deviation

-1 3 (II + III)
Electric axis = Tan
2×I + II – III

(Qa) + (Ra) + (Sa) + (R’a) + (S’a) + for each lead I, II and III.

Analysis category Judgment criteria

Indeterminate axis Electrical axis is indeterminate.


Mild left axis deviation
–5° (0°/ 0°) ≧ Electrical axis > –30°.

Left axis deviation –30° ≧ Electrical axis > –90°, and rejected for left
arterior fascicle block.

Right axis deviation


120° (150°/150°) > Electrical axis ≧ 90° (90°/ 95°).

- 39 -
Analysis category Judgment criteria
Marked right axis
Rejected for left posterior fascicle block, and it meets any of
Deviation
the following conditions.
1) –90° ≧ Electrical axis > –150°, and rejected for S1
S2 S3 pattern.
2) –150° ≧ Electrical axis ≧ –180°.
3) 180°≧ Electrical axis ≧ 120° (150°/ 150°).

S1 S2 S3 pattern
–90° ≧ Electrical axis > –150°, and Sa wave is greater
than Ra wave in lead I, II and III.

6-4 Comments on Hypertrophy

・ Rejected if related to WPW syndrome or complete left BBB.


For implication in right ventricular hypertrophy, it applies only to complete
right BBB that combined with myocardial infarction, right atrial enlargement or
left atrial enlargement.
For paediatric case, different theory (point score) will be applied.

Analysis category Judgment criteria

Left atrial
–Pa ≧ +Pa, and –P ≧ 0.12mV in lead V1.
enlargement

Left Ventricular It meets any of the conditions in 1) to 5), and any of the
hypertrophy conditions in 6) to 10).
1) R(V5) + S(V1) ≧ 3.5 mV
2) R(V5) ≧ 2.6 mV
3) S(V1) ≧ 3.0 mV
4) R(I) ≧ 2.0 mV
5) R(aVL) ≧ 1.5 mV
6) Systolic ≧ 180 mmHg
7) Diastolic ≧ 110 mmHg
8) –30° ≧ Electrical axis > –90°
9) Marked ST-T abnormality, ST-T abnormality or
negative T-wave in lead V4, V5, V6.
10) Rejected for atrial fibrillation, and ST depression is
greater than 0.05mV in lead V4, V5, V6.
Left ventricular high It meets any of the following conditions, and rejected for
voltage left ventricular hypertrophy.
1) R(V5) + S(V1) ≧ 4.0 mV
2) R(V5) ≧ 2.6 mV

- 40 -
・ For implication in right ventricular hypertrophy, it applies only to complete right
BBB that combined with myocardial infarction, right atrial enlargement or left
atrial enlargement.
For paediatric case, different theory (point score) will be applied.

Analysis category Judgment criteria


Right atrial Heart rate is smaller than 130, and positive P-wave is
enlargement greater than or equal to 0.25mV in any of the leads II, III,
aVF, V1 or V2.

Right ventricular It meets both the conditions in 1) and 2), and any of the
hypertrophy conditions in 3) and 4).
1) In lead V1, R-wave is greater than 1 mV, and negative T
is greater than positive T.
2) Sa wave is greater than or equal to Ra wave in lead V5
and V6.
3) In lead V1, Ra wave is greater than Sa wave.
4) In lead I, QRS amplitude is greater than 0.5 mV, and Ra
wave is smaller than or equal to Sa wave.

Right ventricular It meets the following conditions in 〈1〉 or 〈2〉.


hypertrophy ? 〈1〉 It meets any two of the following conditions.
1) In lead V1, Ra wave is greater than Sa wave, and
R-wave is greater than 0.5 mV.
2) In lead, I,QRS amplitude is greater than 0.5 mV,
and Ra wave is smaller than or equal to Sa wave.
3) Sa wave is greater than or equal to Ra wave in lead
V5 or V6.
〈2〉 It meets all of the following conditions.
1) Right atrial enlargement or left atrial enlargement.
2) Marked right axis deviation, right axis deviation or
S1 S2 S3 pattern is present.
3) Sa wave is greater than or equal to Ra wave in lead
V5 or V6.

- 41 -
{Peadiatic} Hypertrophy logic are based on the total points of the following items.

・ Left ventricular hypertrophy (Please count the point of each item only one time,
even more than 2 cases are observed in the same item).

12 – 17 years
Item 0 – 2 years 3 – 11 years Point
Male Female
ST depression (0.05 mV) is present, or negative T amplitude is greater
ST-T 5
than 0.2 mV in any of the lead V4, V5 or V6.

R(V6) ≧ 2.5mV R(V6) ≧ 2.5mV


R(V6) ≧ 3.0mV or
R-wave or or 3
R(V5) ≧ 4.0mV
R(V5) ≧ 3.5mV R(V5) ≧ 3.5mV

R(V6) + S(V1) R(V6) + S(V1) ≧ 5.0mV R(V6) + S(V1)


≧ 4.0mV ≧ 4.0mV
R, S, R(V5) + S(V1) R(V5) + S(V1) R(V5) + S(V1) R(V5) + S(V1) 3
Wave ≧ 5.0mV ≧ 6.5mV ≧ 6.0mV ≧ 5.0mV

S(V1) ≧ 2.0mV

R(II) ≧ 2.5mV and R(Ⅲ) ≧ 2.5mV


R-wave 2
R(aVF) ≧ 2.5mV

Q-wave Qa(V6) > Qa(V5) and Q(V6) ≧ 0.5mV 3

In lead V5 or V6 In lead V5 or V6 In lead V5 or V6


FDT 2
FDT ≧ 0.04 sec FDT ≧ 0.05 sec FDT ≧ 0.06 sec

AXIS AXIS <0° AXIS < -30° 1

- 42 -
・ Right ventricular hypertrophy (Please count the point of each item only one time,
even more than 2 cases are observed in the same item.

12 – 17 years
Item 0 – 2 years 3 – 11 years Point
Male Female
qRS pattern, qS pattern or R pattern 5 in lead V1.
Pattern 5
Negative T or T = 0 and Ra > Sa in lead V1

R(V1) ≧ 2.0mV R(V1) ≧ 1.5mV

R’a >Ra and


R-wave R’ ≧ 1.5mV in R’a > Ra and R’ ≧ 1.0mV in lead V1 3
lead V1.
Ra > Sa and
Ra > Sa and Ra ≧ 1.5mV in
Ra ≧ 1.0mV
lead V1
in lead V1

Sa(V6) ≧ 1.0mV
S-wave 2
Sa ≧ Ra and Sa ≧ 0.5mV in lead V6

FDT FDT(V1) ≧ 0.035 sec (Rejected for incomplete right BBB) 2

AXIS AXIS ≧ 135° AXIS ≧ 120° 1

Analysis category Judgment criteria

Left ventricular Total point is greater than 5 points in the point list of left
hypertrophy ventricular hypertrophy.

Left ventricular Total point is 3 or 4 points in the point list of left ventricular
hypertrophy ? hypertrophy.

Right ventricular Total point is greater than 5 points in the point list of right
hypertrophy ventricular hypertrophy.

Right ventricular Total point is 3 or 4 points in the point list of right ventricular
hypertrophy ? hypertrophy.

Biventricular Total point is greater than 5 points in both point list of left
hypertrophy and right ventricular hypertrophy, or 5 points in either left or
right ventricular hypertrophy and 3 or 4 points in another.

- 43 -
Analysis category Judgment criteria

Biventricular Total point is 3 or 4 points in both left and right ventricular


hypertrophy ? hypertrophy.

6-5 Myocardiopathy

・ Rejected for WPW syndrome, complete left BBB and myocardial infarction.

Region Object leads Judgment conditions

Anterior V2, V3, V4 In case complete right BBB, rejected for


(Rejected lead V2 for female. marked ST-T abnormality, ST-T
V4 only for under 18 years) abnormality or ST-T abnormality ? in
lead V5 or V6.

Lateral I, aVL, V5, V6 R-wave is greater than 0.5 mV in lead


aVL.

Inferior II, aVF Ra wave is greater than Sa wave and


R-wave is greater than 0.5mV in lead
aVF.

・ In case different region has same judgments, analysis categories are combined.
In case same region has multiple judgments, the following priority will be
considered.
Flat T < Negative T < ST-T abnormality ? < ST-T abnormality < Marked
ST-T abnormality.

Analysis
Judgment criteria
category
Marked ST-T [Anterior] (Rejected under 18 years)
abnormality It meets any of the following conditions for object leads.
1) T amplitude < 0mV
2) –0.5mV > Negative T in lead V2 > Negative T in lead V3
or –0.5mV > Negative T in lead V3 > Negative T in lead
V4.
[Lateral and Inferior]
Negative T < –0.5mV in any of object leads.

- 44 -
Analysis
Judgment criteria
category
[Anterior]
It meets any of the following 〈1〉 or 〈2〉 conditions for object leads.
〈1〉T amplitude is smaller than 0mV, plus any of the following
conditions.
1) –0.2mV > Negative T in lead V2 > Negative T in lead
V3.
2) –0.2mV > Negative T in lead V3 > Negative T in lead
V4.
3) Incomplete right BBB and atrial fibrillation is absent, and
Negative T < –0.5mV.
ST-T ・ Under 18 years.
abnormality 1) Incomplete right BBB and atrial fibrillation is absent.
2) Negative T < –0.5mV.
〈2〉ST2 is smaller than or equal to ST1 plus any of the following
conditions.
1) Atrial fibrillation is absent and ST depression ≧ 0.1mV.
1) Atrial fibrillation is present and ST depression ≧ 0.2mV.
[Lateral and Inferior]
It meets any of the following 〈1〉,〈2〉or 〈3〉 condition for object
leads.
〈1〉 Negative T < –0.2mV.
〈2〉 It meets any of the following conditions.
1) Atrial fibrillation is absent and ST depression ≧ 0.1mV.
2) Atrial fibrillation is present and ST depression ≧ 0.2mV.
〈3〉ST2 is smaller than or equal to ST1, plus any of the following
conditions.
1) Atrial fibrillation is absent and ST depression ≧ 0.05mV.
2) Atrial fibrillation is present and ST depression ≧ 0.2mV.
[Anterior]
It meets any of the following 〈1〉,〈2〉or 〈3〉 condition for object
leads.
〈1〉 It meets both following conditions.
1) T-wave amplitude is smaller than 0mV, and Negative T <
–0.2mV.
2) Complete right BBB, incomplete right BBB or atrial
Mild ST-T
fibrillation are absent.
abnormality
〈2〉 It meets any of below conditions.
1) Atrial fibrillation is absent and ST depression ≧ 0.2mV.
2) Atrial fibrillation is present and ST depression ≧ 0.3mV.
〈3〉 ST2 is smaller than or equal to ST1, plus any of the following
conditions.
1) Atrial fibrillation is absent and ST depression ≧ 0.05mV.
2) Atrial fibrillation is present and ST depression ≧ 0.1mV.

- 45 -
Analysis
Judgment criteria
category
[Lateral and Inferior]
It meets any of the following 〈1〉 or 〈2〉 condition for object leads.
〈1〉 It meets any of the following conditions.
1) Atrial fibrillation is absent and ST depression ≧ 0.05mV.
Mild ST-T
2) Atrial fibrillation is present and ST depression ≧ 0.1mV.
abnormality
〈2〉 ST2 is smaller than or equal to ST1, plus any of the following
conditions.
1) Atrial fibrillation is absent and ST depression ≧ 0.02mV.
2) Atrial fibrillation is present and ST depression ≧ 0.1mV.
[Anterior]
It meets condition 1) plus condition 2) or 3) for object lead.
1) Complete right BBB and atrial fibrillation are absent.
2) T-wave amplitude ≦ –0.05mV.
3) T-wave amplitude is smaller than 0mV and Negative T is smaller
Negative T
than –0.1mV.
[Lateral and Inferior]
It meets any of the following 1) or 2) condition for object lead.
1) T-wave amplitude ≦ –0.05mV.
2) Negative T < –0.1mV.
[Anterior]
It meets any of following 1) or 2) condition for object lead.
1) Complete right BBB and atrial fibrillation are absent.
2) T-wave amplitude is smaller than or equal to 0mV and Negative
T is greater than or equal to –0.05mV.
Flat T [Lateral and Inferior]
Negative T is greater than or equal to –0.05mV, plus any of below
the 1) or 2) condition for object leads.
1) T-wave amplitude < 0mV.
2) R-wave is greater than 1mV, and 20×T-wave amplitude ≦
R-wave.

- 46 -
6-6 Bundle-Branch Block
・ Rejected for WPW syndrome.
Analysis
Judgment criteria
category
It meets all of the following conditions.
1) Representative QRS ≧ 0.12 (0.11/0.10) sec.
2) In two leads or more for lead I, aVL, V5 or V6,
Representative QRS width ≧ 0.12 (0.11/0.10).
Complete left
3) In all of lead I, V5 and V6, Q-wave ≦ 0.1mV.
BBB
4) In two leads or more for lead I, aVL, V5 or V6,
R-wave width ≧ 0.09 (0.09/0.08) sec.
5) QRS complex is negative and T-wave is positive.
※Reject the other codes if complete left BBB is present.
It meets all of the following conditions.
1) Representative QRS width ≧ 0.12 (0.11/0.10) sec or in lead V1
or V2, Representative QRS width ≧ 0.12 (0.11/0.10) sec.
2) In lead V1 or V2, R-wave width ≧ 0.06 (0.06/0.05) sec and
Complete right
R-wave ≧ 0.4 (0.5/0.6)mV or
BBB
R’ wave width ≧ 0.045 (0.045/0.04) sec and
R’ wave ≧ 0.4 (0.5/0.6)mV.
3) In two leads or more for lead I, aVL, V4, V5, V6,
(S-wave width + S’ wave width) ≧ 0.04 (0.04/0.36) sec.
It meets all of the following conditions.
1) Representative QRS width ≧ 0.09 (0.09/0.08) sec.
2) In lead V1 or V2, QRS complex is RR’ pattern, or QRS complex
is RSR’ patterns then R’a > Ra and R’ ≧ 0.2 (0.3/0.4) mV.
3) In two of the leads I, aVL, V4, V5 or V6,
Incomplete right
(S-wave width + S’ wave width) ≧ 0.04 (0.04/0.036) sec.
BBB
or
4) Representative QRS width ≧ 0.09 (0.09/0.08) sec.
5) In both leads V1 and V2, QRS complex is RR’ pattern, or QRS
complex is RSR’ pattern then R’a > Ra and R’ ≧ 0.2 (0.3/0.4)
mV.
It meets all of the following conditions.
Intraventricular 1) Complete right BBB, complete left BBB and incomplete right
Block BBB is absent.
2) Representative QRS width ≧ 0.13 (0.12/0.11) sec.
Its meets all of the following conditions.
1) –60° > Electrical axis > –90°.
Left anterior 2) In both leads II and aVL, QRS complex is R pattern or qR
hemi block pattern.
3) In all leads II, III and aVF, QRS complex is RS pattern or QS
pattern.

- 47 -
Analysis
Judgment criteria
category
Left posterior It meets all of the following conditions.
hemi block 1) 120° ≦ Electrical axis ≦ 180°.
2) QRS complex is RS pattern in lead I, and QRS complex is QR
pattern in lead III.
Bifascicular BBB It meets all of the following conditions.
1) Complete right BBB is present.
2) Left anterior hemi block or left posterior hemi block is present.
Trifascicular It meets all of the following conditions.
BBB ? 1) Complete right BBB is present.
2) Left anterior hemi block or left posterior hemi block is present.
3) A-V Block I°, A-V Block II° and complete A-V Block is present.
RSR’ pattern It meets all of the following conditions.
1) Complete right BBB and incomplete right BBB is absent.
2) Atrial fibrillation is absent.
3) R’ wave is greater than 0.1mV in lead V1 or V2.
ST elevation It meets all of the following conditions in V1 or V2.
(Coved Type) 1) STj ≧ ST1 ≧ ST2. (STj: QRS ending point)
2) ST1 ≧ 0.2mV
3) Negative T
Mild ST It meets all of the following conditions in V1 or V2.
elevation 1) STj ≧ ST1 ≧ ST2. (STj: QRS ending point)
(Coved Type) 2) 0.2 > ST1 ≧ 0.1mV
3) Negative T
ST elevation It meets all of the following conditions in V1 or V2.
(Saddleback 1) It meets any of Complete right BBB, Incomplete right BBB or
Type) RSR’ pattern.
2) STj ≧ ST1. (STj: QRS ending point)
3) ST1 ≧ 0.2mV
4) Negative T

6-7 Atrioventricular pathy

Analysis
Judgment criteria
category
WPW syndrome It meets all of the following conditions.
(A type) 1) Representative QRS width ≧ 0.10 (0.095/0.90) sec.
2) Representative PR interval ≦ 0.14 (0.13/0.13) sec and in any
6 leads of 12 leads, FDT time ≧ 0.06 sec, or Representative PR
interval ≦ 0.12 (0.11/0.11) sec and FDT time ≧ 0.066 sec.
3) QRS complex is positive in lead V1.

- 48 -
Analysis
Judgment criteria
category
It meets all of the following conditions.
1) Representative QRS width ≧ 0.10 (0.095/0.90) sec.
WPW syndrome 2) Representative PR interval ≦ 0.14 (0.13/0.13) sec and in any
(B type) 6 leads of 12 leads, FDT time ≧ 0.06 sec, or Representative PR
interval ≦ 0.12 (0.11/0.11) sec and FDT time ≧ 0.066 sec.
3) QRS complex is negative in lead V1.
It meets all of the following conditions.
1) Representative PR interval ≦ 0.115 (0.105/0.105) sec.
WPW ?
2) Representative QRS width ≧ 0.09 (0.085/0.08) sec.
3) FDT time ≧ 0.054 sec in any 5 of the 12 leads.
Short PR Representative PR interval < 0.11 (0.10/0.10)
It meets all of the following conditions.
A-V block I° 1) HR ≦ 100.
2) Representative PR interval ≧ 0.21 (0.20/0.20) sec.
A-V block II° It meets all of the following conditions.
(Wenckebach) 1) PR interval ≧ 0.215 (0.20/0.20) sec.
2) PR interval / Next PR interval ≧ 1.30
3) 1.40 ≦ Next R-R interval / R-R < 2.20
A-V block II° It meets all of the following conditions.
(Mobitz) 1) Next wave has two individual P-waves.
2) 0.80 ≦ PR interval / Next PR interval ≦ 1.30
3) 1.40 ≦ Next R-R interval / R-R < 2.20
A-V block II° R-R interval is normal, and number of heart beat with two
(2:1) individual P-waves are 2/3 of the total heart beats.
Complete A-V It meets all of the following conditions.
block ? 1) Input digitalis in condition or medication.
2) R-R interval is normal, and heart rate is less than 50 per
minute.
Complete A-V It meets all of the following conditions.
block 1) R-R interval is normal, and heart rate is less than 50 (50/60) per
minute.
2) Heart beat without P-wave are less than 1/2 of the total heart
beats.
3) R-R interval is shorter than P-P interval in total heart beat.
Artificial It has pacemaker pulse.
pacemaker ・ In case pacemaker rhythm is detected, other criteria are not
rhythm applicable.
Artificial It has analyzed pacemaker pulse, but it has noise ?
pacemaker ・ In case pacemaker rhythm is detected, other criteria are not
rhythm (noise ?) applicable.

- 49 -
6-8 Myocardial Infarction
・ Rejected WPW syndrome and complete left BBB.
No analysis of myocardial infarction for age under 18 years, only abnormal Q
and
abnormal Q ? will be out put.

Region Object leads Judgment conditions


Rejected if QRS complex is smaller than 0.5 mV
in all three leads. Q-wave is present in leads II
Inferior II, III, aVF and aVF.
Rejected if Q-wave is greater than or equal to 0.1
mV in object leads.
In case QS pattern is present in lead V1 and
Q-wave is present in lead V2, “XXX anterior
infarction” will be analyzed as “XXX
Anterior V2, V3, V4
anteroseptum infarction”.
Rejected if Q-wave is greater or equal to 0.1 mV
in object leads.
Rejected if Q-wave is present in two leads or more
in the object leads.
Lateral I, V5, V6
Rejected if Q-wave is greater than or equal to 0.1
mV in object leads.
Abnormal Q is not present, analysis are based on
High posterior V1 the R/S ratio in lead V1, and T-wave in lead V1
and V5.

Analysis
Judgment criteria
category
Acute inferior It meets all of the following conditions for object leads.
infarction ? 1) ST elevation > 0.3 mV
2) 5Qa > Ra or Q-wave ≧ 0.04 sec.
It meets all of the following conditions for object leads.
Inferior 1) 3Qa > Ra
infarction 2) Q-wave ≧ 0.04 sec
3) ST elevation > 0.15 mV or T-wave amplitude < 0
It meets all of the following conditions for object leads.
Inferior 1) 3Qa > Ra and Q ≧ 0.04 sec
infarction ? 2) 3Qa > Ra, Q ≧ 0.025 sec. and T-wave amplitude ≦ 0
3) 4Qa > Ra, Q ≧ 0.03 sec. and T-wave amplitude ≦ 0
Cannot rule out
inferior 5Qa > Ra and Q-wave ≧ 0.05 sec. in any of object leads.
infarction

- 50 -
Analysis category Judgment criteria
It meets all of the following conditions for object leads.
Acute anterior
1) ST elevation > 0.6 mV
infarction ?
2) 5Qa > Ra or Q ≧ 0.04 sec
Anterior infarction It meets all of the following conditions for object leads.
1) 3Qa > Ra
2) Q ≧ 0.04 sec
3) ST elevation > 0.3 mV or T-wave amplitude < 0
Anterior infarction ? It meets all of the following conditions for object leads.
1) 3Qa > Ra and Q ≧ 0.04 sec
2) 3Qa > Ra, Q > 0.025 sec. and T-wave amplitude ≦ 0.
3) 4Qa > Ra, Q ≧ 0.03 sec. and T-wave amplitude ≦ 0.
Cannot rule out 5Qa > Ra and Q-wave ≧ 0.05 sec. in any of object leads.
anterior infarction

Acute anteroseptal It has acute anterior infarction ? and QS pattern in lead V1.
infarction ?

Anteroseptal It has anterior infarction and QS pattern in lead V1.


infarction

Anteroseptal It has anterior infarction ? and QS pattern in lead V1.


infarction ?

Cannot rule out It cannot rule out anterior infarction and QS pattern in lead
anteroseptal V1.
infarction
Acute lateral It meets all of the following conditions for object leads.
infarction ? 1) ST elevation > 0.3 mV in lead Ⅰ
ST elevation > 0.6 mV in lead V5 and V6
2) 5Qa > Ra or Q-wave ≧ 0.04 sec
Lateral infarction It meets all of the following conditions for object leads.
1) 3Qa > Ra
2) Q-wave ≧ 0.04 sec
3) ST elevation > 0.15 mV or T-wave amplitude < 0
Lateral infarction ? It meets all of the following conditions for object leads.
1) 3Qa > Ra and Q-wave ≧ 0.04 sec
2) 3Qa > Ra, Q-wave ≧ 0.025 sec. and T-wave amplitude
≦ 0
3) 4Qa > Ra, Q-wave ≧ 0.03 sec. and T-wave amplitude ≦
0
Cannot rule out 5Qa wave > Ra wave and Q-wave ≧ 0.05 sec. in any of
lateral infarction object leads.

- 51 -
Analysis
Judgment criteria
category
High-Post It has anterior infarction and meets all of the following conditions
infarction for object leads.
1) R-wave ≧ 0.5 mV or Ra wave ≧ Sa wave in lead V1.
2) T-wave amplitude > 0.4 mV in lead V1.
3) T-wave amplitude in lead V1 > T-wave amplitude in
lead V4 > 0
High-Post It meets following conditions in 〈1〉 or 〈2〉.
infarction ? 〈1〉 It meets all of the following conditions.
1) It has any type of anterior infarction.
2) R-wave ≧ 0.5 mV or Ra wave ≧ Sa wave in lead V1.
3) T-wave amplitude in lead V1 > 0.2 mV or
T-wave amplitude in lead V1 > T-wave amplitude in
lead 5 > 0.
〈2〉 It meets any of the following conditions.
1) R-wave ≧ 0.5 mV or Ra wave ≧ Sa wave in lead V1.
2) T-wave amplitude > 0.4 mV in lead V1 and
T-wave amplitude in lead V1 > T-wave amplitude in
lead 5 > 0.
ST elevation Any kind of myocardial infarction (input patient’s conditions) is
(Rule of Acute present, plus any of the following conditions.
M.I.) 1) It meets any two of the leads Ⅰ, Ⅱ, aVL or aVF, ST elevation
is greater than 0.2 mV.
2) It meets any two of the leads V1, V2 or V3, ST elevation is
greater than 0.5 mV.
3) It meets any two of the leads V4, V5 or V6, ST elevation is
greater than 0.3 mV.
High T (Rule out Any kind of myocardial infarction (input patient’s conditions) is
Acute M.I.) present, plus in any two of the leads, except aVR, positive T-wave
is greater than 1.5 mV.
Poor R It meets any of the following conditions.
progression 1) R ≦ 0.2 mV in both leads V2 and V3, and Ra wave in lead
V2 ≧ Ra wave in lead V3.
2) R ≦ 0.2 mV in both leads V3 and V4, and Ra wave in lead
V3 ≧ Ra wave in lead V4.
3) R ≦ 0.2 mV in both leads V4 and V5, and Ra wave in lead
V4 ≧ Ra wave in lead V5.
4) R ≦ 0.2 mV in both leads V5 and V6, and Ra wave in lead
V5 ≧ Ra wave in lead V6.

- 52 -
Analysis
Judgment criteria
category
Abnormal Q ? * Rejected for any myocardial infarction for each region.
It meets all of the following conditions.
1) Q-wave ≧ 0.15 mV.
2) 3Qa wave > Ra wave.
3) Q-wave ≧ 0.03 sec in any lead I, II, V2 – V6 or
Q-wave ≧ 0.045 sec in lead aVF.

[Under 18 years]
Analysis
Judgment criteria
category
Abnormal Q It meets any of the following conditions.
1) Q-wave > 0.5 mV in any of lead I, II or aVF.
2) Q-wave is present in any lead V1, V2 or V3.
3) Q-wave > 0.5 mV and 5Qa wave > Ra wave in any lead
V4, V5 or V6.
Abnormal Q ? Q-wave > 0.5 mV in any lead V4, V5 or V6.

6-9 Arrhythmia

Analysis
Judgment criteria
category
Left atrial It meets all of the following conditions.
rhythm ? 1) P-wave is negative and T-wave amplitude ≧ 0 in lead I.
2) P-wave is negative in lead V5 or V6.
3) QRS amplitude ≧ 0 in lead V5.
4) R-R interval is normal, and heart rate ≦ 100.
A-V junctional It meets all of the following conditions.
rhythm 1) Representative PR interval < 0.12 (0.10/0.10) sec.
2) P-wave is negative in lead II.
3) P-wave is positive in lead aVR.
4) R-R interval is normal, and heart rate ≦ 100.
Idioventricular It meets all of the following conditions.
rhythm 1) WPW syndrome is absent.
2) Representative QRS width ≧ 0.12 (0.11/0.10) sec.
3) P-wave is not present in all wave.
4) R-R interval is normal, and heart rate < 60.
Supraventricular It meets both of the following conditions.
tachycardia ? 1) R-R interval is normal, and heart rate ≧ 140 (160/180).
2) Representative QRS width < 0.12 (0.11/0.10) sec.

- 53 -
Analysis
Judgment criteria
category
Ventricular It meets all of the following conditions.
tachycardia ? 1) WPW syndrome is absent.
2) Representative QRS width ≧ 0.12 (0.11/0.10) sec.
3) P-wave is not present in all wave.
4) R-R interval is normal, and heart rate > 100.
Sinus It meets all of the following conditions.
tachycardia 1) P-wave is positive in lead Ⅱ.
2) P-wave is negative in lead aVR.
3) R-R interval is normal, and heart rate > 100 (120/130).
Tachycardia Heart rate > 100 (120/130)

Extreme Heart rate > 140 (160/180)


tachycardia

Sinus It meets all of the following conditions.


bradycardia 1) P-wave is positive in lead Ⅱ.
2) P-wave is negative in lead aVR.
3) 50 (50/60) ≧ heart rate ≧ 35 (40/45)
Bradycardia 50 (50/60) ≧ Heart rate ≧ 35 (40/45)

Extreme R-R interval < 35 (40/45)


bradycardia

Atrial It meets all of the following conditions.


fibrillation ? 1) Input digitalis in patient’s conditions or medications.
2) R-R interval is normal, and heart rate < 50.
3) f-wave is present.
Atrial fibrillation It meets all of the following conditions.
1) f-wave is present.
2) P-wave is absent.
3) R-R interval is abnormal.
4) 50 ≦ Heart rate ≦ 100.
Atrial fibrillation It has atrial fibrillation, and heart rate is > 100.
(Tachy)

Atrial fibrillation It has atrial fibrillation, and heart rate is < 50.


(Brady)

Atrial flutter It meets all of the following conditions.


1) F-wave is present.
2) R-R interval is normal.
3) 50 ≦ Heart rate ≦ 100

- 54 -
Analysis
Judgment criteria
category
Atrial flutter It has atrial flutter, and heart rate > 100.
(Tachy)

Atrial flutter It has atrial flutter, and heart rate < 50.


(Brady)

Aberrant It has atrial fibrillation or atrial flutter, and ventricular


conduction or premature beat is present.
VPC
Ventricular It meets both of the following conditions.
premature 1) R-R interval < Average R-R interval.
contraction 2) Ventricular premature beat is present.
Runs of VPC Ventricular premature beat occurs 3 times or more succession.

VPC couplet Ventricular premature beat occurs 2 times succession.

VPC multifocal Different types of ventricular premature beat are present.

VPC bigeminy Alternate normal contraction and ventricular premature beat are
present.

VPC trigeminy Alternate two times of normal contraction and ventricular


premature beat are present.

Frequent VPC Ventricular premature beat occurs 3 (6) times or more.


* Number of VPC may change depending on the analysis time.

VPC (Noise ?) Ventricular premature contraction is detected, but is it noise?

Supraventricular Normal beat is present, and it meets any of the following


premature conditions.
contraction 1) R-R interval / previous R-R interval ≦ 0.80 and
R-R interval / average R-R interval ≦ 0.80
2) R-R interval / previous R-R interval ≦ 0.85 and
R-R interval / next R-R interval ≦ 0.60 and
R-R interval / average R-R interval ≦ 0.80
3) R-R interval / previous R-R interval ≦ 0.95 and
R-R interval / avarage R-R interval ≦ 1.00 and
P-wave are not sinus rhythm.
Runs of SVPC Supraventricular premature beat occurs 3 times or more
succession.

SVPC couplet Supraventricular premature beat occurs 2 times succession.

- 55 -
Analysis
Judgment criteria
category
SVPC bigeminy Alternate normal contraction and supraventricular premature
beat are present.

SVPC trigeminy Alternate two times of normal contraction and supraventricular


premature beat are present.

Frequent SVPC Ventricular premature beat occurs 3 (6) times or more.


* Number of VPC may change depending on the analysis time.

Escape beat It meets both of the following conditions.


1) R-R interval / average R-R interval ≧ 1.20.
2) Ventricular premature beat is present,or P-wave is absent.
Sinus It has no VPC, and it meets the following 1) and either 2) or 3) of
arrhythmia the following conditions.
1) 0.80 ≦ R-R interval / average R-R interval ≦ 1.30.
2) R-R interval / previous R-R interval < 0.85 or
3) R-R interval / previous R-R interval > 1.15.
Sino-Atrial block It has no VPC, and it meets both of the following conditions.
1) 1.75 ≦ R-R interval / average R-R interval ≦ 2.25.
2) This beat has one P-wave only.
Unclassified It does not meet the above arrhythmia conditions.
Arrhythmia
Sinus rhythm It meets all of the following conditions.
1) P-wave is positive in lead II.
2) P-wave is negative in lead aVR.
3) 50 < Heart rate < 100
4) Representative PR interval is present.
5) Arrhythmia, and It meets any of the following statements.
・Ventricular premature contraction
・Supra ventricular premature contraction
・Sinus arrhythmia
・A-V block II°( Wenckebach )
・A-V block II°( Mobitz )
Normal It meets all of the following conditions.
sinus rhythm 1) P-wave is positive in lead II.
2) P-wave is negative in lead aVR.
3) 50 < Heart rate < 100
4) Representative PR interval is present.
5) Regular rhythm

- 56 -
6-10 Post-Exercise ECG Analysis
In the case that the following finding occur after exercise test, but are absent from
pre-exercise.
Positive exercise It meets any of the following conditions.
test 1) These analysis category is not present before stress, and
present after stress.
・ A-V block II° (Mobitz)
・ Complete A-V block
・ Complete left BBB
・ Bifascicular BBB
・ Marked ST-T abnormality relationship
・ ST-T abnormality relationship
・ Myocardial infarction relationship
・ Atrial fibrillation relationship.
・ VPC (Frequent, couplet, runs, multifocal, bigeminy,
trigeminy)
・ Supraventricular tachycardia ?
・ Ventricular tachycardia ?
・ SVPC (Frequent, couplet, runs, bigeminy, trigeminy)
・ Idioventricular rhythm
・ Sino-Atrial block
・ Extreme bradycardia

2) It meets both of the following conditions in leads I, II, aVF, V4,


V5 or V6.
a) It has ST depression in resting ECG.
b) ST depression is greater than 0.01mV after stress.
Negative It does not meet above conditions.
exercise test

- 57 -
7. Minnesota Code (except Cardico 302)

Please take note that the Minnesota Code is primarily established for cording of
ECG waveform classification and is intended to conduct the epidemiological study,
and it would not be suitable for the use of clinical diagnosis.

7-1 Notation of Classification

1. Classification of age & sex.


(1) In case the criteria are different due to different age group, the following
descriptions will be made.
e.g.) Representative QRS with ≧ 0.12 (0.11/0.10) sec.
0.12 sec ・・・・・・・・ Criterial for age 15 years and above. [Adult]
0.11 sec ・・・・・・・・ Criterial for age between 10 and 14 years.
0.10 sec ・・・・・・・・ Criterial for age between 0 and 9 years. [Child]

(2) Without inputting age and sex.


If age of patient is not input, the patient’s age will be treated as 30 years.
If sex of patient is not input, the patient’s sex will be treated as male.

2. Unit of criteria.
(1) Time duration ・・・・・・・・・ second
(2) Voltage (Amplitude) ・・・ mV

3. Phrases
(1) Positive deflection ・・・・・・・・・・・・・・・ (Qa) + (Ra) + (Sa) + (R’a) + (S’a)
(2) QRS amplitude ・・・・・・・・・・・・・・・・・・ Peak to peak of QRS complex.

- 58 -
7-2 Code 1
・ Single type of Code and printout starting from the lower number.
・ Rejected for WPW syndrome and complete left BBB.

Code No Object leads Description


1-1-1 V2 ・ Q-wave/R-wave ≧ 1/3, or QS pattern
・ Q-wave duration ≧ 0.03 sec
・ R-wave ≧ 0.03 mV
V3 or V4 ・ Q-wave/R-wave ≧ 1/3, or QS pattern
・ Q-wave duration ≧ 0.03 sec
I ・ Q-wave/R-wave ≧ 1/3, or QS pattern
・ Q-wave duration ≧ 0.03 sec
II ・ Q-wave/R-wave ≧ 1/3, or QS pattern
・ Q-wave duration ≧ 0.03 sec
1-1-2 V3 or V4 ・ Q-wave duration ≧ 0.04 sec
・ Q-wave ≧ 0.12 mV
V1 or V2 ・ Q-wave duration ≧ 0.04 sec
・ R-wave ≧ 0.03 mV
I, V5 or V6 ・ Q-wave duration ≧ 0.04 sec
・ Q-wave ≧ 0.12 mV
II ・ Q-wave duration ≧ 0.04 sec
・ Q-wave ≧ 0.12 mV
1-1-3 aVL ・ Q-wave duration ≧ 0.04 sec
・ R-wave ≧ 0.3 mV
・ Q-wave ≧ 0.12 mV.
1-1-4 II and aVF ・ Q-wave duration ≧ 0.05 sec in lead II
・ Q-wave ≧ 0.1 mV in lead aVF
1-1-5 aVF ・ Q-wave duration ≧ 0.05 sec
・ Q-wave is > 0.12 mV
1-1-6 V2, V3, V4, ・ QS pattern and R-wave is present in the right side lead.
V5 or V6 (e.g. The right side lead of V3 is V2).
1-1-7 V1, V2 or V3 ・ QS pattern

- 59 -
Code No Object leads Description
1-2-1 V3 or V4 ・ Q-wave/R-wave ≧ 1/3, or QS pattern
・ Q-wave duration ≧ 0.02 sec
V2 ・ Q-wave/R-wave ≧ 1/3, or QS pattern
・ Q-wave duration ≧ 0.02 sec
・ R-wave ≧ 0.03 mV
I, V5 or V6 ・ Q-wave/R-wave ≧ 1/3, or QS pattern
・ Q-wave duration ≧ 0.02 sec
II ・ Q-wave/R-wave ≧ 1/3, or QS pattern
・ Q-wave duration ≧ 0.02 sec
1-2-2 V2, V3 or V4 ・ Q-wave duration ≧ 0.03 sec
・ Q-wave ≧ 0.12 mV
I, V5 or V6 ・ Q-wave duration ≧ 0.03 sec
・ Q-wave ≧ 0.12 mV
II ・ Q-wave duration ≧ 0.03 sec
・ Q-wave ≧ 0.12 mV
1-2-3 II ・ QS pattern
1-2-4 III and aVF ・ Q-wave duration ≧ 0.04 sec in lead III
・ Q-wave ≧ 0.1 mV in lead aVF
1-2-5 aVF ・ Q-wave duration ≧ 0.04 sec
・ Q-wave ≧ 0.12 mV
1-2-6 III or aVF ・ Q-wave ≧ 0.5 mV
1-2-8 V2 or V3 ・ 0 mV < R-wave ≦ 0.2 mV
・ R’-wave = 0, or R’-wave is not present.
V3 and V4 ・ 0 mV < R-wave ≦ 0.2 mV
・ R’-wave = 0 mV, or R’-wave is not present.
V4 and V5 ・ 0 mV < R-wave ≦ 0.2 mV
・ R’-wave = 0 mV, or R’-wave is not present.
V5 and V6 ・ 0 mV < R-wave ≦ 0.2 mV
・ R’-wave = 0 mV, or R’-wave is not present.
1-3-1 V2, V3 or V4 ・ Q-wave/R-wave ≧ 1/5, or QS pattern
・ Q-wave duration ≧ 0.02 sec
I, V5 or V6 ・ Q-wave/R-wave ≧ 1/5, or QS pattern
・ Q-wave duration ≧ 0.02 sec
II ・ Q-wave/R-wave ≧ 1/5, or QS pattern
・ Q-wave duration ≧ 0.02 sec

- 60 -
Code No Object leads Description
1-3-2 V1 and V2 ・ QS pattern.
1-3-3 aVL ・ Q-wave duration ≧ 0.03 sec
・ R-wave ≧ 0.3 mV
・ Q-wave ≧ 0.12 mV
1-3-4 III or aVF ・ Q-wave duration ≧ 0.03 sec in lead III
・ Q-wave ≧ 0.1 mV in lead aVF
1-3-5 aVF ・ Q-wave duration ≧ 0.03 sec
・ Q-wave ≧ 0.12 mV
1-3-6 III and aVF ・ QS pattern

7-3 Code 2
・ Single type of Code and printout starting from the lower number.
・ If the deflection of QRS is 0.2mV or less in lead I, Minnesota Code 2-5 is output and
no other check of Code 2 is made.
・ Rejected for WPW syndrome, complete left BBB and low voltage (limb leads).

Code No Object leads Description


2-1-1 ・ –60° ≧ Electrical axis > –90°

2-1-2 ・ –30° ≧ Electrical axis > –60°

2-1-3 ・ –5° ≧ Electrical axis > –30°

2-2 ・ 120° (130°/ 140°) ≦ Electrical axis <180°


・ –150° ≧ Electrical axis ≧ –180°
2-3 ・ 90° (95/ 100°) ≦ Electrical axis <120°

2-4 ・ –90° ≧ Electrical axis ≧ –150°

2-5 I, II and III ・ Sum of QRS algebraic amplitudes = 0

- 61 -
7-4 Code 3
・ Single type of Code and printout starting from the lower number.
・ Rejected for WPW syndrome and complete left BBB.

Code No Object leads Description


3-1-1 V6 ・ R-wave > 2.6 (3.0/3.5) mV
3-1-2 V5 ・ R-wave > 2.6 (3.0/3.5) mV
3-1-3 I, II, III or ・ R-wave > 2.0 (2.5/3.0) mV
aVF
3-1-4 aVL ・ R-wave > 1.2 (1.5/2.0) mV
3-2 V1 ・ R-wave ≧ 0.5 (1.5/2.0) mV, or
R’-wave ≧ 1.0 (1.3/1.5) mV.
・ R-wave ≧ S-wave in lead V1. (only for adult)
・ R-wave/S-wave in lead V1 > R-wave/S-wave in lead
V2. (only for adult)
3-3-1 V1 and V6 ・ R-wave in lead V6 + S-wave in lead V1 > 3.5 (4.0/5.0)
mV
3-3-2 V1 and V5 ・ R-wave in lead V5 + S-wave in lead V1 > 3.5 (4.0/5.0)
mV
3-3-3 I ・ R-wave > 1.5 (2.0/2.5) mV
3-4-1 V2 ・ R-wave + S-wave > 7.0 mV. (only for child)

3-4-2 V3 ・ R-wave + S-wave > 7.0 mV. (only for child)

3-4-3 V4 ・ R-wave + S-wave > 7.0 mV. (only for child)

- 62 -
7-5 Code 4
・ Single type of Code and printout starting from the lower number.
・ Rejected for WPW syndrome and complete left BBB.
・ All leads of V1, V2, V3 and V4 are not used for analysis of Complete Right BBB,
Incomplete Right BBB and Intraventricular Block.
・ All lead of V1, V2, V3 and V4 are not used for analysis of child age groups of 7 years
or less.
・ All lead of V1), V2) and V3) are not used of child age groups of 8 -12 years.

Code No Object leads Description


4-1 I, II, aVL, ・ ST depression ≧ 0.1 mV
aVF or V1 –
V6
4-2 I, II, aVL, ・ 0.1 mV > ST depression ≧ 0.05 mV
aVF or V1 –
V6
4-3-1 I, II, aVL, or ・ 0.05 mV > ST depression ≧ 0.03 mV
V3 – V6 ・ Negative T-wave ≧ 0.05 mV
4-3-2 aVF ・ 0.05 mV > ST depression ≧ 0.03 mV

7-6 Code 5
・ Single type of Code and printout starting from the lower number.
・ Rejected for WPW syndrome and complete left BBB.
・ All leads of V1, V2, V3 and V4 are not used for analysis of Complete Right BBB,
Incomplete Right BBB, Interventricular Block and Atrial Fibrillation.
・ All leads of V1, V2, V3 and V4 are not used for analysis of male 12 years or less,
and female 30 years or less.
・ Both leads of V1 and V2 are not used for analysis of female 31 years or greater.

Code No Object leads Description


5-1 I, II, aVF or ・ Peak of T-wave is present lower than ST segment.
V2 – V6 ・ Negative T-wave ≧ 0.5 mV
aVL ・ Peak of T-wave is present lower than ST segment.
・ Negative T-wave ≧ 0.5 mV
・ R-wave ≧ 0.5 mV

- 63 -
Code No Object leads Description
5-2-1 V2, V3 or V4 ・ Peak of T-wave is present lower than ST segment.
・ Negative T-wave ≧ 0.2 mV
I, II, V5 or ・ Peak of T-wave is present lower than ST segment.
V6 ・ Negative T-wave ≧ 0.1 mV
aVL ・ Peak of T-wave is present lower than ST segment.
・ Negative T-wave ≧ 0.15 mV
・ R-wave ≧ 0.5 mV
aVF ・ Peak of T-wave is present lower than ST segment.
・ Negative T-wave ≧ 0.1 mV
・ R-wave > (either greater Q-wave or S-wave)
5-2-2 V2, V3 or V4 ・ Peak of T-wave is present lower than ST segment.
・ Negative T-wave ≧ 0.1 mV
5-3 V2, V3 or V4 ・ Peak of T-wave is present lower than ST segment.
・ 0.2 mV > Negative T-wave ≧ 0.05 mV
I, II, V5 or ・ Peak of T-wave is present lower than ST segment.
V6 ・ 0.1 mV > Negative T-wave ≧ 0.05 mV
aVL ・ Peak of T-wave is present lower than ST segment.
・ Negative T-wave ≧ 0.05 mV
・ R-wave ≧ 0.5 mV
I, II, aVF or ・ Positive T-wave < 0.01 mV
V2 – V6 ・ R-wave ≧ 0.5 mV
5-4 I, II, aVF or ・ T-wave/R-wave < 1/20
V2 – V6 ・ R-wave ≧ 1 mV
5-5 I, II, aVF or ・ 1/20 ≦ T-wave/R-waves < 1/10
V2 – V6 ・ R-wave ≧ 1 mV
5-6 V1 ・ Only for 7 years or less.
・ Negative T-wave = 0 mV
・ Positive T-wave > 0.3 mV

- 64 -
7-7 Code 6
・ Single type of Code and printout starting from the lower number.
・ If the artificial pacemaker rhythm is present, Minnesota Code 6-8 is output and no
other check of Code 6 is made.

Code No Description
6-1 ・ Complete A-V block is present.
6-2-1 ・ A-V Block II° (2:1) is present.
6-2-2 ・ A-V Block II° (Mobitz) is present.
6-2-3 ・ A-V Block II° (Wenckebach) is present.
6-3 ・ Adult age groups : PR interval ≧ 0.22 sec.
(If Heart Rate ≧ 100, PR interval ≧ 0.20 sec)

・ Child age groups : PR interval ≧ 0.20 sec.


(If Heart Rate < 60, PR interval ≧ 0.22 sec)
6-4 ・ WPW syndrome is present.
6-5 ・ PR interval < 0.12 (0.11/0.10) sec
Rejected A-V Block II°, Complete A-V Block
6-8 ・ Artificial Pacemaker Rhythm

7-8 Code 7
・ Single type of Code and printout starting from the lower number.
・ Rejected for WPW syndrome.

Code No Description
7-1 ・ Complete Left BBB is present.
7-2 ・ Complete Right BBB or Bifascicular BBB is present.
7-3 ・ Incomplete Right BBB is present.
7-4 ・ Intraventricular Block is present.
7-5 ・ RSR’ pattern is present.

- 65 -
7-9 Code 8

Code No Description
8-1-1 ・ Supraventricular Premature Beat is present
8-1-2 ・ Ventricular Premature Beat, or VCP (noise?) is present
8-1-3 ・ SVPC trigeminy is present.
8-1-4 ・ VPC trigeminy is present.
8-1-5 ・ SVPC Bigeminy is present.
8-1-6 ・ VPC Bigeminy is present.
8-1-7 ・ Frequest PAC is present.
8-1-8 ・ Frequest PVC is present.
8-2-1 ・ Ventricular Tachycardia? is present.
8-2-2 ・ Runs of PVC or VPC couplet is present.
8-3-1 ・ Atrial Flutter is present.
8-3-2 ・ Atrial Fibrillation is present.
8-4-1 ・ Supraventricular Tachycardia? is present.
8-4-2 ・ Runs of PAC or SVPC couplet is present.
8-5 ・ Idioventricular Rhythm is present.
8-6-1 ・ A-V junctional Rhythm is present.
8-6-2 ・ Left Atrial Rhythm is present.
8-7-1 ・ Extreme Tachycardia is present.
8-7-2 ・ Tachycardia is present.
8-7-3 ・ Sinus Tachycardia is present.
8-8-1 ・ Exteme Bradycardia is present.
8-8-2 ・ Bradycardia is present.
8-8-3 ・ Sinus Bradycardia is present.
8-9-1 ・ Sinus Arrhythmia is present.
8-9-2 ・ Sino-Atrial Block is present.
8-9-9 ・ Unclassified Arrhythmia is present.

- 66 -
7-10 Code 9
・ Print out [9-8] if unrecognazed wave form is present.
・ If Dextraocardia? is present, Minnesota Code 9-6-1 is output and no other check of
Code 9 is made.
・ If Arm Leads Reversed? is present, Minnesota Code 9-6-2 is output and no other
check of Code 9 is made.

Code No Description
9-1-1 ・ Low Voltage (limb leads) is present.
9-1-2 ・ Low Voltage (chest leads) is present.
9-2-1 ・ ST Elevation is present.
9-3-1 ・ Right Atrial Enlargement is present.
9-3-2 ・ Left Atrial Enlargement is present.
9-4-1 ・ Counterclockwise Rotation is present.
9-4-2 ・ Clockwise Rotation is present.
9-5 ・ Very large T-wave is present.
9-6-1 ・ ‘Dextraocardia ?’ is present.
9-6-2 ・ ‘Arm Leads Reversed ?’ is present.
9-7-1 ・ QT Prolongation is present.
9-8 ・ No analysis is available, or there is AC or muscle tremor.

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8. Long-Term Mode (except Cardico 302)
8-1 Preface

・ The function of Long-term mode is different depending on the ECG model.


・ Depending on the setting, ANST Test and Arrhythmia Analysis can be selected.

Model Recording Compress waveform ANST Test Arrhythmia Analysis


Cardico

1210
Cardico
○ ○ ○
1211

8-2 Arrhythmia Analysis

1. Outline.
Ventricular Premature Contraction, Supra-Ventricular Premature Contraction,
Atrial Fibrillation are detected by using the rhythm leads (Lead II and V1). In
order not to affect the accuracy of the detection, please attach at least 4 limbs and
V1 electrodes onto the patient and perform the test.
If there is noise interference from the unattached electrodes that affected the
detection accuracy, please attach all chest electrodes and do the test.

2. Flow chart.

Start (1) Recording ECG


ECG of all leads are recorded every 10 seconds
from the time when the START key is pressed.
Record ECG (10 sec)
(2) QRS Band Detection/ Parameter Measurement
Please refer to [Procedure of Automatic Analysis
QRS Band detection 1-5 Waveform Measurement].

(3) Arrhythmia Analysis.


Parameter Detection of Ventricular Premature Contraction,
Supra-Ventricular Premature Contraction, Atria
Fibrillation.
Arrhythmia Analysis
(4) Repeat the process within the time limit.
NO
End of time limit ※ Note
As arrhythmia detection is not performed on real
time, detection is done a while (Maximum 10 sec)
End
after VPC appeared on the screen.

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3. Accuracy of detection.
Please refer to P.3 [Caution while using the machine].

8-3 Examination of Autonomic Nervous System

1. Outline.
It measures the variation of R-R intervals, and analyzes the heart rate variability.
The test can be done by attaching only the 4 limbs electrodes, however, if there is
noise interference from the unattached electrodes that affected the detection
accuracy, please attach all the chest electrodes and do the test.

2. Flow chart.

Start (1) QRS Band detection / Store R-R value.


The different in value for the current and
previously detected QRS band (R-R
No interval) is stored.
QRS Band detection

YES (2) Repeat the process within the time limit or


the pre-set heartbeats.
Store R-R values
(3) Decide valid or invalid beat.
No
For all the R-R intervals stored, only those
End of time limit, or achieve R-R intervals that can be applied to the
the pre-set heartbeats below formula are considered as valid beats.
0.1≧|(R-R – Mean R-R) / Mean R-R|
・ If there is any heartbeat that can be not
Decide valid or invalid beat be applied to the above formula, that
particular beat and the next 2 beats (3
beats) will be treated as invalid beats,
Measurement of Heart Rate and exclude for the analysis.
Variability Analysis
(4) Measurement of Heart Rate Variability
Analysis.
Measurement will be performed according to
End
the following items.

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Item Unit Content
Valid beat/Total beat Beat/Beat Total beat : All the heartbeats
recorded during the
checking time.
Mean R-R Interval Sec Mean value of valid beats (R-R
interval)
Maximum R-R Interval Sec Maximum value of R-R interval
Minimum R-R Interval Sec Minimum value of R-R interval
Maximum – Minimum Sec Maximum – Minimum R-R interval
Standard Deviation (SD) Sec Calculate from the following formula
Coefficient of Variation % Calculate from the following formula
(CVRR)

Calculation

n
2
Σ {(R–Ri) – (R-Rmean)}
i=1
Standard Deviation (SD) =
n–1

Coefficient of Variation (CVRR) = (SD / R-R mean)×100.

R-R mean : Mean R-R interval (average value of valid R-R interval).
n : Valid heartbeats.
R-Ri : R-R interval of valid beat.

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