2017-03-21

1

At the Core of Medical Technologywww.medi-core.com

INTRODUCTIONSA3000NEW

Stress is the root of almost disease.

2017-03-21

2

Functions

HRV theory APG theory

ANSLoad test + Pediatric

Peripheralblood circulation

1. Stress test2. Assessment of ANS function3. Predictor of cardiovascular disorder4. Vascular health / Peripheral circulation5. Stress relaxation / Improvement of immune system

Breathingtraining

RSA training

This test is to check the autonomic nervous system which controls the Homeostasis in inner body and also analyze the balance between the Sympathetic and Parasympathetic nerve function in the autonomic nervous system.

1) Main functions of ANS à Control of Homeostasis.(Maintain the Life tendency)

What is the Autonomic Nerve System test?

- ANS Function –

1. Control the activity of life in our inner body – Homeostasis

2. Control all of organic activities such as gastric fluid and intestine peristalsis

3. Control the arterial function

4. A key of immune system

5. A nearotransmitter that accelerates or restrains the vital activities, hormone, internal secretion

Endo

Maintenance of Homeostasis

Immune

HormoneANS

Maintaining the Homeostasis is an ability of keeping the stable healthy condition regardless of change of external environment like temperature and nutrient status

2017-03-21

3

1) Diseases related with the ANS dysfunction

: Headache, Dizziness, Irritable bowel syndrome, Sleep disorder, Chronic fatigue, Lack of appetite, Digestive dysfunction, Depression, Anxiety, PTSD, DM, Hypertension, Sudden death!!

From the adult disease to psychiatric Disease

2) Recent Trend : No any abnormal symptoms but feel pains and abnormally functional problems. Now these

patients are on rise. à 70% out of internal medicine has psychiatric dysfunctions

~ All of this come from the ANS dysfuctions.

What is the Autonomic Nerve System test?

This test is to check the autonomic nervous system which controls the Homeostasis in inner body and also analyze the balance between the Sympathetic and Parasympathetic nerve function in the autonomic nervous system.

Functio-nalDisease

Lack of immune system, headache, Dizziness

Lack of appetite

Metabolic syndrome, Obesity, Hypertension

Depression, Anxiety, Lethargy

Irritable Bowel Syndrome

DM, Sleep disorder

Chronic fatigue, Stress

What’s the ANS ?

l ANS innervated in internal organs, regulates key functions involuntarily through its 2 branch, SNS (Sympathetic Nervous System) and PNS (Parasympathetic Nervous System)

l ANS acts for heart rate control including hormonal, enzymatic, respiratory, pulmonary, urinary and uterine neural control

l SNS : Metabolic energy supply to the cardiovascular system for blood pressure,heart rate and blood circulation control

l PNS : Organic protection, Energy conservation and restoration

• The Aims of ANS -> To maintain homeostasis

Recently, a lot of people suffers with somatic diseases without pathological abnormality. It’s realized for the importance of the ANS

Diseases related to ANS dysfunctionDiabetes, Hypertension, Irritable Bowel Syndrome, Headache, Sudden Death after MI, Depression, Anxiety, Sleep disorder

Branch Heart beatBlood vessel

Respiration PupilDigestive

liquorSweat

SNS Accelerate Constrict accelerate dilate Inhibit Accelerate

PNS Inhibit relax Inhibit contract accelerate Inhibit

2017-03-21

4

ANS analysis method

HRV(Heart Rate Variability)

Gastrointestinal Motility Assessment

Analysis for the Neurotransmitter in blood

Electrophysiological Assessment

GSR (Galvamic skin response)

Pupillary reflex

Most Reliable ANS Index, HRV

There are about 20,327 papers on PubMed site till Sep. 2016

2017-03-21

5

Who need the Heart Rate Variability

Chronic fatigue

Excessive stress

Functional indigestion

Headache / Migraine

Obesity

Adult diseases

(Hypertension, Diabetes, Hyperlipidemia)

Inertia, drowsy

Failure of

the concentration & memory

Disease prevention and

management by

objective diagnosis

▶ Oriental reference1. Clinical reference research at 8 major hospitals in Korea

- Pusan University Hospital- Donga University Hospital- Seoul Baek Hospital of Inje University- Eulgy University Hospital- Ihwa University Hospital- Dankuk University Hospital- Ghil University of Ghachun Medical College- Sungshim University of Hanlim University

2. Clinical research for 2 years (from May 2001 to June 2003)

3. Acquired 3,600 normal cases

4. Build Oriental Reference for the 1st in the world and get its Patent

5. There are big difference of normal range between western and oriental people

Clinical research

2017-03-21

6

Comparison for the REF

30

40

50

60

70

80

90

100

110

10 20 30 40 50 60

Ages

Heart R

ate

(bpm

) .

Western

Male

Female

3239 people(M:1753, F:1486)

• Male 1753 (40.8±11.4 years old)

• Female 1486 (39.7±12.8 years old)

Comparing to the data of HeartMath Research Center in USA

Comparison for the REF

-1.0

-0.5

0.0

0.5

1.0

1.5

2.0

2.5

3.0

20 30 40 50

Ages

LF/H

F Ra

tio

Western

Male

Female

0

20

40

60

80

100

120

10 20 30 40 50 60

Ages

SDNN

(ms)

Western

Male

Female

2017-03-21

7

● Patent in Korea ● ● Patent in Japan ●

Patent

Certificates

● CE ● ● FDA ● ● SFDA ●

2017-03-21

8

Part 1. H R V

Heart Rate Variability

Autonomic Nervous System which affects the sinoatrial node, is

changed every moment by internal or external environment.

HRV, heart rate variability is the degree of fluctuation in the length

of the intervals between heart beats.

0.8 -> 1.0 -> 0.9 -> 1.0 (sec)845 -> 1049 -> 911 -> 1023 (msec)

1) What’s the HRV

2017-03-21

9

• 18th Century Albrecht von Haller noticed heart beat not regular

• 1965 Hon & Lee noticed that the beat to beat interval changes are the first alteration before fetal distress occurs. R-R change precedes HR change

• 1971 Sayers and others focused on rhythm imbedded in beat-to-beat HR

• 1977 Wolf et al showed association of HR to sudden death post MI

2) HRV History

• 1981 Akselrod introduced Power Spectral Analysis (PSD)

• Late 1980’s HRV confirmed strong predictor of mortality after an acute MI

• 1996 Task Force publish Standards of Measurement for HRV

Circulation 1996:93:1043-1065

• 2000 publications over the last decade, found with a MEDLINE search, key word heart rate variability “HRV”

2) HRV History

2017-03-21

10

The Task Force (1996)

Establish guideline about HRV analysis in 1996

HRV STANDARD GUIDELINE

By The European Society of Cardiology

& The North American Society of Pacing and Electrophysiology

2) The history of HRV

Under steady state condition, the heart rate is monotonously regular.

* 1929 Walter B. Cannon : “homeostasis”

* Physiology –all cells, tissues and organs maintain a staticor “steady-state” condition in their internal environment

Old

n Biological Process vary in a complex andnonlinear way evenduring “steady-state”condition

New concept

Under steady state condition, the heart rate is also not regular.

continuous timeseries data from physiologic processes such as

Heart rate,Blood pressure,Nerve activity…

3) The generation of HRV

2017-03-21

11

AutonomicNervousSystem

S

Internaldisturbance

CardiacInherent Rhythm

(SA node)

Fluctuationof

Heart Rate

Emotional EffectThermo-regulationBody Posture(BP)

Illuminationetc......

ANS DisorderCardiovascular Diseases

NeuropathyStress / Aging

etc.....

3) The generation of HRV

Proper ANS regulation lead to bigger fluctuation of HR

HRV Signal Induction

0 50 100 150 200 250 300 350 400

165

170

175

180

185

190

195

Time[sec]

RR

n-1

RR

n

RR

n+1

X X X X X X X X X X X X X X

X X X X

4

0 0.05 0.1 0.15 0.2 0.25 0.3 0.35 0.40

1

2

3

4

5

6

7

8x 10

Frequency (Hz)

PSD

(m

s2/H

z)

VLF LF HF

Time Domain

Frequency Domain

4) Analysis Method

2017-03-21

12

Signal - View

Frequency axis

Time axis

Time Domain Frequency Domain

4) Analysis Method

5) Parameter

Mean HRSDNNRMSSD

PSIApEnSRD

TPVLFLFHF

LF normHF norm

LF/HF ratio

Time Domain Analysis Frequency Domain Analysis

2017-03-21

13

Standard Deviation

Mean HR

HRV

1.SDNN (Standard Deviation Normal to Normal)- Standard deviation of total N-N intervals

- Reflect the variation of HR

5) Parameter – Time Domain

Above 50 Good

25-50 Normal

15-25 Note

Below 10 High risk of functional disorder

or disease

1. SDNN (Standard Deviation Normal to Normal)

- Stress dissolution ability

5) Parameter – Time Domain

2017-03-21

14

- The healthy have complex HRV signal.

- General Health IndicatorDecreased in HRV has increasing attention as a prognostic indicator of risk associated with a variety of chronic diseases ,behavioral disorder, mortality and aging

- Lowered copying ability to maintain Homeostasis

The meaning of decreased SDNN(Standard Deviation Normal to Normal)

5) Parameter – Time Domain

Healthy

Unhealthy

1) HRV Tachogram : Irregular, complex as healthy

<Graphic view of SDNN>

5) Parameter – Time Domain

2017-03-21

15

Healthy: wide,flat Unhealthy: narrow ,sharp

2) Histogram : X axis is RR interval , Y axis is Numbers

As the healthier, X axis is wide, and Y axis is low

5) Parameter – Time Domain

Healthy :wide, spread Unhealthy : narrow,concentrate

3) RRV : Both X and Y axis indicate heart beats For the healthier person, RRV spreads widely

5) Parameter – Time Domain

2017-03-21

16

¢ Assessment of parasympathetic nervous activity which is one of Autonomic Nervous Systems related to the heart.

¢ Before coming the heart dysfunction or disorder symptom, RMSSDshows lower than the healthy person

-> SDNN decrease and RMSSD decrease (10↓) : Increases the risk of heart disease

2. RMSSD ( Square root of the mean of sum of the square of differences

between adjacent NN intervals)

5) Parameter – Time Domain

3. PSI (Physical Stress Index)The pressure loaded on regulation system

- By the virtue of exercise or other physical activity, Heart Rate(HR) increases

-> At the moment, HRV (Heart Rate Variability) lessens-> increases the pressure loaded regulation system

-The degree of pressure loaded on regulation system, drawn from the time domain parameters such as HR, the distribution of HRV & RR interval

Healthy: green normal zone Unhealthy: higher stress lead to placethe bar on red higher zone

5) Parameter – Time Domain

2017-03-21

17

4. ApEn (Approximate Entropy)

Statistic value of complexity for the beat to beat interval

- Healthier person has higher value

5. SRD (Successive Approximate Entropy)

compare the fixed section of fore part as baseline with the change degree, result of rear part during the test

- Index to judge if the regular status keeps going - If the value is ‘1’, it indicates the regular status maintains

5) Parameter – Time Domain

1). VLF (Very low frequency)- 0.0033-0.04Hz- provide the additional information of sympathetic

and parasympathetic nervous system

2). LF (low frequency)- 0.04-0.15Hz. Also known as “Mayer” waves.- Relative low frequency element in adjacent 0.1 Hz to control the blood pressure and reflect the activities of mechanism

- Seems to be related to both SNS and PNS activity

3). HF (High frequency)- 0.15-0.4Hz- Respiratory band : Relative high frequency element related to respiratory activity

- Indicative of parasympathetic nervous system (vagus nerve)

1. VLF,LF,HF5) Parameter – Frequency Domain

2017-03-21

18

- The overall value (log) of TP, VLF, LF and HF is indicated by bar graph and normal range by “I”shape.

- The bar for the healthy will be placed inside normal zone (I shape).

- If the patient will be in pathology state or chronic stress, the bar will be placedbelow normal range (I shape).

1.TP,VLF,LF,HF

5) Parameter – Frequency Domain

Reduction of TP Reductionof VLF

Reduction of LF Reduction ofHF

*Lessen theability of bodytemperatureregulation

*Hormone disorder

*Loss of energy*Fatigue*Insufficient Sleep*Lethargy

*Chronic stress*Aging*Reduced

electrical stability of heart

*Functionalindigestion

UnhealthyHealthy

*Decreased ANS function*Lowered regulation

competence*Decreased ability to cope

with the requirement of continuously changing environment

5) Parameter – Frequency Domain

2017-03-21

19

2. LF norm , HF norm

- The ratio of value subtracts VLF from Total Power to LF or HFLF norm = LF / LF + HF - > Sympathetic nervous systemHF norm = HF / Lf + HF - > Parasympathetic nervous system

- Reflects the regulation and balance degree of autonomic nervoussystem.

3. LF / HF ratio

- Reflects the general balance degree between sympathetic and parasympathetic nerve by LF:HF ratio

- This value is direct proportion about the activity of sympathetic nerve. In the other hand, it is inverse proportion about the activity of parasympathetic nerve.

5) Parameter – Frequency Domain

4. Autonomic Balance Diagram : X axis is LF, Y axis is HF

If LF and HF value are in normal range, the spot marks around the center. Otherwise, in the ill state, fall down from the center.

5) Parameter – Frequency Domain

2017-03-21

20

Healthy: balanced state

SNS vs PNS = 6:4 ,5:5 ,4:6

(Upper tone of SNS)

Unhealthy: ANS dysfunction

SNS dominant state

(SNS) (PNS) (SNS) (PNS)

<LF/HF ratio>

1) SNS & PNS: relative ratio between sympatheticand parasympathetic activity

5) Parameter – Frequency Domain

HealthyAt the middle green zone,steady emotional state

Under emotional Stress- Low : depression mood- High : Anxiety mood

2) Emotional State: reflects stability of theemotional state based on LF/HF ratio

5) Parameter – Frequency Domain

2017-03-21

21

Healthy Unhealthy

vs

6) Healthy vs Unhealthy

7) HRV Report ANS Balance Test Report

(for professional )DDR (Direct Diagnosis Result) Report

(for the patient)

2017-03-21

22

Part 2. HRV Load Test

SU

PIN

E

UPR

IGH

T

2017-03-21

23

• No need hard performance ability of exam(HRV: objective exam).

• Significant accurate diagnosis than static HRV testè HRV PSD Analysis: Sensitive Tool for early

diagnosis (3min or 5min measurement)

• Cardiovascular complication,Predictor of Sudden death.

• Scientific Method [ www.pubmed.com // medline HRV search è 20,000 papers]

Necessity of – HRV load test

• All values of Frequency Domain parameter are decreased.

: Decreased in autonomic nerve activity and in activities of SNS

and PNS as well

• Not appeared the increase of LF(SNS).

: No any response for the stimulus of Sympathetic Nerve System

• No change in LF/ HF ratio (LF Norm).

: Lowered in response for the stimulus of Autonomic Nerve System

• Abnormally decrease in TP.

Abnormal Status While HRV Orthostatic Test

2017-03-21

24

• Association of Diabetic Neurology -5 Major university hospitals

(in 2006~2007)

- Junbook University (Pf. Tae-Sun Park)

- Inha University (Pf. Yong-Sung Kim)

- Soonchunhyang University (Pf. Ji-Ho Mok)

- Gachun Medical University, Gil Hospital (Pf. Gi-Young Lee)

- Buchun Sejong Hospital (MD. Jong-Hwa Kim)

Significant Parameter : HR + SDNN + LF Norm + LF+ HF è Clinical correlation : 98% in 2015

• CANRISK : Normal : Less than 50Borderline: 50 ~ 55 less High risk : more than 55

• HRV load test lead significant accuracy in Cardiovascular Autonomic Neuropathy test.

HRV load test – clinical research

2017-03-21

25

Part 3. HRV TEST For PEDIATRIC

Pediatric & Teens’ Mental Health

Pediatric Teens

▶ Segregation with mom▶ Discrimination for child▶ Uneasy family background▶ Frequent moving▶ Excessive pre-schooling

▶ Burden for the entrance exam. and score

▶ Conflicts with parents and family▶ Feud with friends▶ Heterosexual problem▶ Changed physically and emotionally

Main cause of their Mental Health

- Reduce the stress resistance caused by the long-term exposure of mental stress

- Lowered in autonomic activities and balance.

Depression, anxiety, loss of concentration, ADHD, friend relationshipAttitudes, addicted Internet use, and suicidal impulse

2017-03-21

26

- ADHD, Hyperactivity Disorder

- Learning disability, Test Anxiety

- Depression, Anxiety

- The social and personal relationship

- Attachment Disorder, Separation

Anxiety Disorder

- Stress and addicted Internet use

Measuring tool for children’s physical and mental health

- Check Mental Stress and emotional state.

Consulting Tool after Objective Diagnosis- Solution of subjective diagnosis with the survey.

- Veiled disease /ADHD / Violent child / Depression / Psychiatric disorder

Outstanding diagnosis for psychiatric health- A new tool for pediatric and youth screening

- Personalized care (especially trait anxiety)

HRV Application for Pediatric and Teens

2017-03-21

27

Heart Rate for Pediatric, Teenagers

1. Normal Heart Rate

- Adults : 60~80 bpm

- Children : Different from ages

Preschooler : 95~110 bpm Child: 80~90 bpm Teenagers : 65~80 bpm

2. Abnormal Heart Rate

- Adults: 3 Min. Mode ( Over 5 times) / 5 Min. Mode (Over 8 times)

- Children: 0~20 times – normal status After 18 years old, the HR will be stabilized.

Over 20 times: Try it again. If kept the abnormal case, ask to the doctors.

2017-03-21

28

Adults Pediatric, Teenagers

Good 50 ↑ 70 ↑

Normal 30-50 45-69

Careful 20-29 30-44

Bad 20 ↓ 30 ↓

SDNN (Standard Deviation Normal to Normal)

- An indicator for evaluating the recovery from stress

Main Parameters

Part 4.

2017-03-21

29

RSA is the signal of the sympathetic and vagal nerves affecting the sinoatrial node Normal rhythm of arrhythmia caused by respiration(I.e., a variation in heart rate caused by breathing)

Respiration

HR Graph at stable status

HR Graph after RSA breathing

This training is to analyze the personal fatigue and stress level and help the personal breath training. After all, the HRV signal can be regularly patterned as a biofeedback.

u Objective : Allow an individual to achieve a more relaxed and balanced state of autonomic balance or homeostasis.

u Training Term 2 ~ 3 times/weekly, 6 weeks recommended . Much better if you can do RSA everyday.

2017-03-21

30

Increase Decrease □ Test Scores

□ Attention □ Mental Clarity □ Classroom Behaviors □ Locus of Control (resistance to peer pressure) □ Discrimination and Reaction

Times □ Decision Making □ Work Management and

Focus □ Readiness to Learn □ Teacher Comfort □ Family Relationships

□ Anxiety □ Anger □ Hostility □ Risky Behavior □ Depression □ Overall Psychological

Distress □ Physical Symptoms of stress

Effect of RSA

• Abdominal breathing stimulating phren : Upper abdomen not moving,but lower abdomen breaths with bulging. (Induces the longer breathing)

• Breathing stimulates the phren to activate the parasympathetic nervesystem. Parasympathetic nerve plays a role of releasing the agitation ofsympathetic nerve caused by the stress.

• Have the same effect as abdominal breathing when you make thoracicbreathing.

2017-03-21

31

Decide the targeting breath numberafter the trial Test.

(1) Breathing numbers per Min.* Beginner à 10~14 times* Skilled person à possible to maintain

the stable status though breathingunder 0 time.

(2) <Inhale: Exhale>Rate & difficultyEasy / Normal / Difficult .Breathing rate àInhale : 4 : Exhale : 6Automatic setting for Inhale

(shorter) and Exhale (longer).

(3) Biofeedback – Target breathing for individually correct numbers.

Free – Select free setting for breathingnumbers.

RSA result

Breathing Time: 3~10 Min.Target Breathing: 10~12 TimesBreathing Score: Over 50-Good

2017-03-21

32

RSA Result

Frequency Domain changing at real time

Breathing Score

■ When the breathing number is selected, the frequency domain according to the breathing per minute will be automatically displayed with blue line.

■ Based on the respiratory numbers and respiration rate, the length of green graph will be changed on the scope of blue line.

VLF LF HF

■ Evaluate the RSA training■ Wether following the training completely during the specific time, the score will be decided. (0 ~ 100 Score)

u Bad: Under 25 Normal : Under 50u Good: 75 Excellent : Over 75

Application

▶ Stress Clinic: Depression, anxiety, physical disability, pain etc. Diagnosed disorder related the stress and treatment

▶ Examination Center: Preventive care for adults disease ; neurological disease, sudden cardiac death

▶ Chronic Fatigue Clinic: Lowered regulatory disorder, hypertension, anti-aging, diziness

▶ Examinee Clinic: Loss of concentration ability, learning disability, student’s stress management

▶ Obesity Clinic: Stressful obesity, eating disorder, problem of ANS by the obeisty

2017-03-21

33

Part 5. A P G

Accelerated PlethysmoGraph

1) Plethysmograph (PTG )

• The PTG waveform is extracted from the change of light absorption amount in hemoglobin by “Lambert Benr” principle.

• By receiving the light passed through finger tip from light-emitting diode having a wavelength of 840nm on the upper offinger to light receiving diode (Photo diode) on the down of finger, extracting a change in the amount of transmitted light as a pulse wave.

• The change of absorption amount in the the hemoglobin is also changed according to variation in the blood volume, the amount of hemoglobin inside blood vessel. The bigger changing amount of blood make the greater amplitude of the pulse wave.The great amplitude means bigger vascular dimension.

2017-03-21

34

* Regional classification: carotid pulsation, radius arterial pulsation, femoral arterial pulsation

* Classification by detection method: Oscilation, Plethysmograph

* Artificial processing of Plethysmograph: PTG, VPG, APG

Artificial processing of the Plethysmograph

Plethysmogram(PTG)- Basic wave form

Velocity Plethysmogram(VPG)

Acceleration Plethysmogram(APG)

1st Diff.

2nd Diff.

2) Plethysmograph (PTG )

a : Basic point to evaluate APG waveform

b：Cardiac constriction power (Cardiac output)

The deeper (–) value is better shape

c：Arterial ElasticityHigher (+) value is better

d： Remaining blood volumeHigher value, smaller (-) value is better

Differential Pulse Index( DPI):b-c-d / a

3) APG waveform

* The gradient of b & d point

: vascular state and its aging degree

2017-03-21

35

7 levels by the vascular

state

Classifying the wave type as aging .

4) Vascular Level

Blood circulation and its vessel are good

Current blood circulation and its vessel are good, but may go bad

Start to get aged in the vessel

Not good at the blood circulation and aged state in the vessel

Blood circulation disorder

5) Correlation to Age1) DPI (Differential Pulse wave Index)

: Aging degree of the blood vesselb-c-d / abigger (-) value means younger state in the vessel

2) EC (Eccentric Constriction Power) – b/a: Cardiac constriction power. Bigger (-) value means better state in the peripheral circulation

3) AE (Arterial Elasticity) – c/a: The degree of arterial constriction and relaxation function. It reflect tension of the wall in the blood vessel.The bigger (+) value is better.

4) RBV ( Remaining Blood Volume – d/a: It reflect remained blood volume after arterial constriction. The higher value, smaller (-) value is better

2017-03-21

36

6) APG REPORT

1. Wave analysis result

2. Vascular state

analysis result

3. Result comparing

to similar aged

people

4. Comment

٧ Peripheral blood circulation disorder

٧ Early detection of arteriosclerosis and its processing

٧ The cardiovascular system dysfunction including

myocardiac infarction

٧ Judgment about Medicine treatment

7) Clinical significance

2017-03-21

37

Pneumonia

Diabetes

8) Clinical cases (pre, post-treatment)

level 5 level 3

level 6 level 3

9) Normal & Abnormal Artery

Normal artery Abnormal artery with plagues

2017-03-21

38

10) Cautions for measurement

§ Do not move or talk during the measurement. § Do not exercise and relax about 10 minutes in measuring room before

taking measurement.§ Do not strain and then take regular breath. Refrain slow breath during

taking measurement.§ Keep the height of the sensor same to the heart.§ The measurement should be taken with eye open.§ Consult with doctor in case of arrhythmia or cardiac disease.§ Measuring in the morning recommended§ Refrain from smoking, taking drug or coffee 3 hours prior to the

measurement.§ Refrain drinking the day before taking measurement.§ Refrain from wearing accessories (ring, watch, manicure on a nail) that may

interfere accurate measurement.§ Avoid measurement after meal.§ Keep quiet and comfortable conditions in the room.

(room temp.22℃ ~26℃)

Thank you