lifepatch 1 for 2lifepatch.eu/lifepatch.pdf · · 2016-06-037 ans is like the ... speed meter...

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ContentsLIFEPATCH® - “1 for 2” ........................................................................................ 3Patients’ concerns ............................................................................................... 4Health Management with LIFEPATCH® Fitness? ......................................... 4LIFEPATCH® can answer such concerns ........................................................ 4HRV is an important indicator for fitness ..................................................... 4Factors influencing Heart rate validity .......................................................... 5Heartbeat as seen by ECG ................................................................................ 6Why Heart rate validity is a Suitable Diagnostic Tool? ............................ 7ANS is like the driver of the Human Body ................................................... 8

Health Management with LIFEPATCH® Balance ......................... 9LIFEPATCH® Balance ........................................................................................... 10Validity of Measurement / Recording ............................................................ 11Heart Balance........................................................................................................ 11Autonomic Regulation ....................................................................................... 12Hormonal Balance ............................................................................................... 12CO2 Regulation (Sleep pattern) ....................................................................... 13Deep Sleep Phase (nRem3) .............................................................................. 13

Cardiological Parameters with LIFEPATCH® Cardio ............... 14Atrial Fibrillation (AF Burden) ......................................................................... 15Repolarisation (QTC) .......................................................................................... 15Standard deviation of normal heartbeats (SDNN) .................................... 16

Health Management with LIFEPATCH® ............................................. 17Skin Preparation ................................................................................................... 18Sensor Hygiene and Maintenance .................................................................. 18Storing / disposal of electrodes ...................................................................... 18Operating instructions ....................................................................................... 19

For further information, consult the instructions for use of the specific LIFEPATCH equipment ............................................ 20

Know your numbers and what they mean.

Know your numbers. 2

LIFEPATCH 1 FOR 2

LIFEPATCH® - “1 for 2” One measurement caters for two different analysis

Health Management

LIFEPATCH® Balance LIFEPATCH® Cardio

• Recording / analysing of the Heartrate Variability (HRV)

• Stress - analysis• Sleep - analysis

• Longterm ECG Recording• Arrhythmia Recording• Up to 72 hours

Disease Management

1 for 2 1 measurement = 2 outcomes LIFEPATCH® BALANCE LIFEPATCH® CARDIO

Application Heart fitness holistic health indicators

Heart arrhythmialongterm ECG

Analysis results Validation of patient‘s current healthstatus and system balance

Pathological status of patient‘s heart

Medical aid Self payment Co-payment


PATIENTS CONCERNS

Patients’ concerns

• I am so exhausted lately

• I am often stressed and irritable

• I want to run a marathon

• I don‘t sleep so well

• My Dad died of a sudden heart attack

• I want to get fit

• I do train and engage in sports but always feel exhausted

• I cannot get any inner peace

• I am often very tired and fall asleep already in the mornings

• I excercise a lot, is that good for my heart?

• I get palpatations

Health Management with LIFEPATCH® Fitness?

• A measuring and monitoring tool to identify your internal body balance• It establishes the state of balance of the ANS (autonomic nervous system)• Determines through indicators the quality of sleep and measures over time

the improvement (deterioration) of health status• Identifies cardiological risk factors such as atrial fibrillation and other heart

problems

LIFEPATCH® can answer such concerns

• LIFEPATCH® will test if your body system is balanced• With LIFEPATCH®, we can detect if the heart is fit or if referral to a cardiologist

is necessary and cardiological advice is appropiate to strengthen your heart• LIFEPATCH® determines your heart and body fitness and we can develop a

progamme to manage your future health • LIFEPATCH® tells us how you sleep and if your recovery periods during deep

sleep phases are sufficient• With LIFEPATCH® we can monitor your health better and identify stress factors,

mental as well as physical load during your work day

HRV is an important indicator for fitness

• The sympathetic nervous system (SNS) and the parasympathetic nervous system (PNS) influence the heart rate

• A functioning ANS, the rhythm of beats will change continuously • Heart rate validity (HRV) can be measured with a surface ECG• HRV is the distance between two heart beats measured in the ECG • HRV is a very good and early indicator to detect changes in the ANS• HRV can be used to monitor and control therapy outcomes• HRV enables early / in time detection of negative factors within the body’s system• Recognition of cardiological relevant factors (obtaining advice from / referring to

a cardiologist) is a positive result measuring the HRV with a LIFEPATCH® ECG• HRV – variation in the time interval between heart beats• How the heart reacts to various influences ?• What is the HRV significance• What is the HRV significance


FACTORS INFLUENCING HEART RATE

Factors influencing Heart Rate Variability (HRV)

Endogenious Exogenic

Constitutional

Breathing, blood pressure, body temperature,

Hormones, illness, heart frequency

Body position, cardio rhythm, food, drugs, stress, mental and body activities,

environment

Age, gender, body fat, weight, fitness,

genetic makeup


HEARTBEAT ECG

Heartbeat as seen by ECG

R

S

TP

Q

Depolarisationof the ventricles

Delay byAV-Node

Depolarisationof the right &

left atrium

Repolarisationof the ventricles

Depletion ofcharge carrier

QRSComplex

STSegment

PRSegment

PR Interval

QT Interval


WHY HRV

Why HRV is a Suitable Diagnostic Tool?

• The heart rate can be derived non-invasively with a surface ECG• The heart rate is controlled by both branches of the ANS

Heart rate

CO2

Bloodpressure

Temperature

1s 120s

120s

120s

10m

6h

24h

10s

100s

1.000s

10.000s

100.000s


ANS DRIVER

ANS is like the driver of the Human Body

Parasympathic Sympathic

Blood Pressure

CO2 Temperature

Simple Control Loop

General Concept Control Loop

100 km/h

100 km/h

Set thethrottle

Set thethrottle

On-board computer

Meter speed

Meter speed

Acceleration or slowdown

Acceleration or slowdown

Read speed from gauge

• Establish and maintain a stable state of the system • Compensate for disturbances which might affect the process

To illustrate the universal principle of a control circuit, an example from everyday life was shown here: driving a car. The driver pressed the accelerator pedal, which determines the amount of fuel to the engine. Depending on the amount of fuel flowing into the pistons a certain torque is achieved, which ultimately causes an acceleration or deceleration of the vehicle. The driver can read off the current speed on the speedometer and adjusts the accelerator pedal position (i.e., the amount of the fuel) according to achieve and maintain the desired speed.

In highway cruising, the driver can delegate this cruise control to the on-board computer. The driver sets the desired target speed and the onboard computer tries to minimize the difference between desired and actual speed through appropriate accelerator pedal position. Certain external influences, such as a climb of the road, shall be compensated automatically. The driver is relieved thereby and can draw his attention to more complex problems, such as e.g. the assessment of the weather conditions and the adjustment of the speed.

A loop is used to establish and maintain a specific state. A key factor that distinguishes a loop from a simple control is the feedback branch. For a stable control loop must this feedback against work place value.

SET POINTPROCESSCONTROLER

READING - FEEDBACK


HEALT MANAGEMENT LF FITNESS

Health Management with LIFEPATCH® Balance


LIFEPATCH PRO – Sensor• 2 Lead Sensor (no • re-usable• up to 72 h data storage• accurate medical grade recording• ECG & HRV analysis • comfortable over time of usage• hygiene – disposable electrode• environmentally friendly• platform for other applications


• 1, 2 & 3 Lead Sensors (cables)• re-usable• up to 72 h data storage• bluetooth short term recording• accurate medical grade recording• ECG & HRV analysis • hygiene – disposable electrode• environmentally friendly• platform for other applications

LIFEPATCH LIGHT – Sensor


LIFEPATCH FITNESS

LIFEPATCH® Balance

Regression pNNmax CAR Regulation CO2 RSA LOCK78ms 61.3% 0.8 22.7% 8.6%

Validity

97.6%

APNOEASSTRESS

Assessment of Heart-Fitness

Estimation of Resilience

Hormonal Balance

Undesireable Respiration

patterns

Level of Coherence

(Regeneration)

51

Af Burden0.0%

QTC391ms

SDNN162.4

CardioAutonomic Regulation

HRSD

SDI

rMSS

pNN50

HFLF

VLF

ULF

SDA

PWR

Load / Recovery

Day Night

Strain

Active

Regeneration

Unspecific

Stress / Recovery Balance

Heart Rate

Night

(HR)-i [BpM]

95.3(HR)-i [BpM]

37.6

153.6

58.3 53.3

90.9

Day

Estimation of severe CVDs


HRV• HRV measures the minimal changes of elapsed time between two hearbeats (R- peaks). • The minimal change between one beat to the next heartbeat provides clear indications of the presence of stress, as well as the capacity and capability

of a human to regulate heart functions.

68 bpm

880ms

859ms

879ms 881ms

869ms 876ms

880ms 878ms

871ms

70 bpm


LIFEPATCH – Balance – HRV parametersDASHBOARD DASHBOARD 2 TRENDS TABULAR HRV ECG

HF NORMALIZED - LOG(LF/HF)

RMSSD

PNNMAX

CSI

71.0

0.0log(LF/HF)

0.0HF normalized [%]

50.2rMSSD[ms]

101pNNmax[ms]

1.5CSI

HRV TOTALS

Valid blocks [%] LF-i[ms2] SDNN-i

59.6 500 45min(HR)[BpM] log(lf/HF)-i SDANN

38.3 0.23 39min(HR)-i [BpM] SDNN [ms] Regression

56.2 79.1 83max(HR)-i [BpM] SD1 [ms] AF Burden [%]

92.8 25.4 0.0Ø(HR) [BpM] SD2 [ms] pNN50 [%]

68.9 108.9 12.6Ø(HR)-i [BpM] SD1/SD2 ratio pNNmax [ms]

67.3 0.233 84HF-i [ms] rMSSD [ms] TINN [ms]

293 35.9 1216

TIME Activity Comment Duration... Validity... Ø(HR)[... min(HR)... max(HR)... SDNN [... SDSD [... SD1 [ms] SD2 [ms] SD1/SD2 rMSSD [... VLF-i [ms.

22:42:34 17894.5 98.6 65.3 42.8 93.0 54.8 30.4 21.5 74.4 0.289 30.4 1266

09:00:00 68836.0 58.3 70.5 38.3 174.4 78.9 38.0 26.9 108.3 0.248 38.0 1129

Ø(HR) [Bmp]


VALIDITY OF MEASURMENT

The reading should preferrably be in a rangein excess of 80 to 90%.

If below the above threshold the measurement should be repeated.

Validity defines the quality of the measurement expressed as the percentage of how many Sinus–Rythms were recognised and can be included in the analysis.

The quality depends on the good fit of the sensor and the electrodes on the clean (hairless) skin of the patient. However, some deterioration in the measurement can never be excluded as it may be influenced when excercising etc.

Validity of Measurement / Recording

Definition Meaning Action

Validity

97.6%

Regression is a non-linear parameter gained preferrably on a 24 hour measurement. Methodically all stable rMSSD/HR pairs of a 24 hour. Reading are collected and statistically calculated. The mean change of the variability relative to the respective heart is considered using the linear regression. This indicator is individually very stable and thus serves to establish the degree of heart fitness.

> 100 indicates good body fitness. 40 – 70 are low body fitness and below 40 bad fitness and potential neuropathy.

> 100 maintain fitness levels.

> 40 – 70 < mobilise patient unless there are other medical conditions.

< 40 mobilise patient under therapeutic supervision.

Elasticity (Regression) The strength of relative changes in the heart frequency is dependent on the actual heart frequency. Higher heart frequencies favor the sympaticus and the sympathic nervous system minimises rapid changes in the heart frequency.

When rapid frequency changes occur the faster sympathetic nervous system is dominant.

Heart Balance


pNNmax

78ms

Regression

51


AUTONOMOCE

Values around 100% indicate an average (normal) autonomic regulation. Thus half of the relevant peer group has either a higher or lower value.

Higher than 100% indicates a better condition of the patient whereas a lower one indicates the reverse. CAR does consider age and gender however any deviation of the above mean may be due to other influencing factors.

Lower day / night rythms are suspect to Neuropathy or Diabetes Mellitus.

Higher values indicate a sensitivity for catecholaminen (Adrenalin, Cortisol); or a potential deterioration of adrenal gland functions.

In case of a lower than the mean (100) measurement an appropiate and patient specific fitness programme should be developed and monitored with quarterly measurements.

Further analysis and consultation with a specialist such as Endocrinologist is indicated.

During the day the heart rate is influenced by different and conciously controlled processes. During the sleep phase a conscious control is not possible and thus the heart beat is controlled autonmocially. To evaluate the autonomic regulation only the sleep periods are considered. Based on empirical data the important and traditional HRV parameters and their distribution is considered.

CAR is calculated for each of the individual HRV parameters over the respective sleep period. The results are then compared and expressed in percent as to how they deviate from the control group. The data is derived from more than 15.000 records of pathologically neutral persons in the age of 20 to 60 years. Aside from the age the relevant control group is drawn on basis of gender, weight and an activity protocoll is available. Exceptions are made when weight exceeds 90 Kg and the length of the sleeping period is less than 5 hours.

In stressful situations Adrenalin enters the blood stream and causes the heart beat to increase. The hormonal influences are determing factors for the development of illness of the weakening of the heart.

Circadiane rhythmic is determined in the chronobiologie when an accumulation of the endogenous (internal) rhythms are experienced over an approximately 24 hours period. The more familiar of these circadiane rhythms is the sleep / wake rhythm. The circadiane rhythm is also referred to as the “internal clock”.

In healthy individuals we note a a stable distribution independent of gender or age.

Autonomic Regulation

Hormonal Balance

Definition

Definition

Meaning

Meaning

Action

Action

CAR

61.3%

0.8

Regression


HRV – Case studiesPATIENT A: VERY VITAL SIGNS

HEART RATE VARIABILITY - DEVIATION

PARASYMPATHETIC NERVE

SYMPATHETIC NERVE

HEART RATE VARIABILITY - DEVIATION

PATIENT B: ‘‘BURN-OUT“

10:00 12:00 14:00 16:00 18:00 20:00 22:00 00:00 02:00 04:00 06:00 08:00

10:00 12:00 14:00 16:00 18:00 20:00 22:00 00:00 02:00 04:00 06:00 08:00

20:00 04:00 12:0000:00 08:00 16:0022:00 06:00 14:0002:00 10:00 18:00

20:00 04:00 12:0000:00 08:00 16:0022:00 06:00 14:0002:00 10:00 18:00


HRV – early detection of stress and the “burn-out” process

2. Increased engagement

12. Burn-out

11. Depression

10. Sense of emptiness

9. Loss of sense of selfworth

8. Apparent behavioral changes

7. Retreat

6. Increasing denial of problems that start to surface

5. Change in values

4. Displacement of conflicts

3. Ignoring own health needs

1. Need to prove oneself

REDUCED PERFORMANCE

6-18 MONTHS 4-12 MONTHS 9-24 MONTHS

WORK PERFORMANCE

TIME

50%

100%

ABSENT REBUILDING PERFORMANCE

Early indications should ALWAYS be taken seriously!As of stage 6 professional help is urgently needed!

EXHAUSTIONWORK PERFORMANCE


HRV – Case study, female high performace athlete - exhaustion / depression

0.40

0.30

0.20

0.10

-100

140

120

100

80

60

40

-50

50

0

08h 09h 10h 11h 12h 13h 14h 15h 16h 17h 18h 19h 20h 21h 22h 23h 02h 03h 04h 05h 06h12 Sept




CO2 SLEEP PATTERN

The body experiences the CO2 regulation as an emergency reaction and reducing the deep sleep phases, even in some cases waking up (Arousal). CO2 regulation indicates what percentage of the sleep phase ANS was with the CO2 regulation. Up to 15 % do not influence the deep sleep phase negatively. Approaching > 30% indicates a reduced deep sleep phase. In cases of delayed REM phases a particularily strong CO2 regulation will occur shortly after falling asleep.

Such cases should, if they present similar picture when a second and third measurement is taken over time, be presented to a sleep lab.

The ANS plays a part in regulating the acid / base balance of the blood. Chemoreceptors recognise increased acidity and the ANS reacts with stimulating deep breathing to exhale CO2 and re-establish the chemical balance in the blood.

A similar reaction is experienced in oxygen deprevation.

As this regulatory process has a time constant of approximately 20-30 seconds and thus influences the heart frequency.

CO2 homeostasis is maintained through automatic regulation. With a rise in CO2 blood levels, the patients is aroused from the deep sleep phase to breathe and increases their tidal volume.

CO2 Regulation (Sleep pattern)


CO2

22.7%

The RSA Lock indicates what percentage of the patients sleep pattern was spent in the energy conserving state (regenerative deep sleep phase).

A normal body should at least have periods of 10% in the deep sleep phase to experience a relaxing and regenerative sleep.

N3 distribution

If the value is positive the sleep cycle is at the beginning of the night. If the value is negative the sleep cycle is at the end of the night.

A desireable reading should be around 15%. If the value is below 15% then additional recordings are recommended.

If, while observing percentage changes, it does not improve a sleep lab should be consulted.

During a deep sleep phase the ANS syncronises the heart beats to conserve energy and thus optimises the exchange of oxygen / CO2.

Deep Sleep Phase (nRem3)


RSA lock

8.6%


HRV – Case study, good as opposed to bad sleep patterns

22h 23h 01h 02h 03h 04h 05h 06h 07h8 April


HRV – Case study, from depressive to recovery

07h

07h

07h

08h

08h

08h

09h

09h

09h

10h

10h

10h

11h

11h

11h

12h

12h

12h

13h

13h

13h

14h

14h

14h

15h

15h

15h

16h

16h

16h

17h

17h

17h

18h

18h

18h

19h

19h

19h

20h

20h

20h

21h

21h

21h

02h

02h

02h

03h

03h

03h

04h

04h

04h

05h

05h

05h

22h

22h

22h

23h

23h

23h

29 May

29 March

29 June

MAY 2013

MARCH 2014

JUNE 2014

Power: 5859 ms2

VLF: 2313 ms2 LF: 2256 ms2

HF: 859 ms2

ø HR: 79 bpmpNN50 Schlaf: 47%

Power: 6665 ms2

VLF: 3350 ms2

LF: 1862 ms2

HF: 836 ms2


Power: 9257 ms2

VLF: 5023 ms2

LF: 2323 ms2

HF: 1095 ms2



HRV – Case study, alcohol at play

07h 08h 09h 10h 11h 12h 13h 14h 15h 16h 17h 18h 19h 20h 21h 02h 03h 04h 05h22h 23h 19 May

0.40

0.30

0.20

0.10

07h 08h 09h 10h 11h 12h 13h 14h 15h 16h 17h 18h 19h 20h 21h 02h 03h 04h 05h22h 23h 29 June

0.40

0.30

0.20

0.10

150

100

50

150

100

50

[Hz]

[Hz]

[BpM

][B

pM]

HRV POWER SPEKTROGRAM

HRV POWER SPEKTROGRAM

HR TREND

HR TREND

No alcohol in the eveningø HR Night: 63 BPMø HR day: 86 BPMPower Night: 9437 ms2

Alcohol in the eveningø HR Night 83 BPMø HR day : 89 BPMPower Night: 1355 ms2


CARDIOLOGICAL PARAMETERS

Cardiological Parameters with LIFEPATCH® Cardio


ATRIAL

Patient has the risk of atrial fibrillation and may experience subsequent complications.

If present and after elimination of non-pathological causes it is recommended that a cardiologist is consulted.

Athletes can present partially chaotic rhythms which can be mistakenly identified as atrial fibrillation and repeated measurements are advised >1%.

Indicates what percentage of the measurment showed an irregular heart rythm, which in most cases may be due to atrial fibrillation.

In cases where the relaxed patient is an athlete the situation is not pathological.

In any event the quality of the recording (validity) should be looked at and if below 90% another measurment is indicated.

Atrial Fibrillation (AF Burden)


> 400 ms < 440 ms raised QTc continue to monitor, monthly recordings are recommended if persitent consult internist.

> 440 ms pathologic – consult an cardiologist.

> 500 ms life threatening danger! Immidiatly consult a cardiologist or physician.

< 400 ms no problem. > 400 ms < 440 ms raised QTc. > 440 ms pathologic. > 500 ms life threatening danger!

The contraction of the heart is initated by an electrical stimulus. Before another contraction can occur the electric impulses have to leave the cells.

The time in which this repolarisation occurs is named the QT-interval

Repolarisation is dependent on the heart frequency and a corrective value becomes the QTc time.

Too long QTc time indicates a potential problem providing the wrong stimulus for the metabolism.

Pathologically long QTc times are a signal for electrical instability (lack of electrolytes) and weak pump action of the heart muscle.

Should review sleep wake periods.

Repolarisation (QTC)


Af Burden

0.0

Range Meaning< 500 ms life threatening

> 440 < 500 ms Problem, suspect

long QT-Syndrome

> 400 < 440 ms Elevated QT time

> 330 < 400 ms Normal QT Time

> 300 ms Suspect QT

Syndrome

QTC

391


STANDARD DEVIATION

Value of < 50 ms signals a lowered LVEF and consultation with a cardiologist is recommended.

50-100 ms repeat measurement within two weeks.

An individual beat to beat interval (distance between two consecutive R-peaks of normal beats in sinusrhythm) is measured at RR-Distance in milliseconds (ms). The HRV analysis examines all RR intervals in nonsequencial (chaotic) secquence to establish their deviation.

The following factors can influenece the SDNN:

Body position, activity, age, gender and fitness level.

Standard deviation of normal heartbeats (SDNN)


Range Meaning< 50 ms extremely low

> 50 < 100 ms low

> 100 < 180 ms normal

> 180 ms above normal for athletes otherwise signal for arrhythmia

SDNN

162.4


HEALTH MANAGEMENT WITH LP

Health Management with LIFEPATCH®


SKIN PREP

Skin Preparation

Storing / disposal of electrodes

Sensor Hygiene and Maintenance

• A hairy chest (men) should be shaven where the patch is to be positioned• Prior to positioning the patch – clean the skin• Make sure skin is free of any creams or lotions prior to attaching electrode

• After use and data transfer of the file the sensor is to be cleaned with surgical wet wipes (70% alkohol)• Do not use any other solvents or cleaning liquids as they may damage the sensor• Do not sterilise or clean under running water!• Check if the sensor is fully charged (lights on steady), otherwise charge the sensor with the charger or through a USB connection on your laptop or computer. • If the sensor has not been used for a week, it does require a top up charge• Sensors, USB cable and charger should not be stored in the sun

• Electrodes should not be exposed to extreme temperature – store at room temperature• Do not expose to direct sun light as otherwise the adhesive will deteriorate• If the electrodes are in their sealed orginal packaging and were exposed to temeratures in excess of 35˚ Celsius – cool them in the fridge for an hour• Electrodes are disposal products and should be disposed as class A waste


OPERATING INSTRUCTIONS

Operating instructions

Place the LIFEPATCH® ECG Recoder in the socket of the LIFEPATCH® ECG Electrode and press the two firmly together until you hear a click-sound.

Starting recording

Hold the LIFEPATCH® ECG Recoder with one hand. Get a hold on the back liner of the LIFEPATCH® ECG Electrode with the other hand. Peel it away from the LIFEPATCH® Electrode taking care not to touch adhesive area.

Shave off any hair and clean the skin, ensure it’s dry where the LIFEPATCH® will be placed.

1.

2.

3.

Pull the snip under the LIFEPATCH® ECG Recorder clockwise around the LIFEPATCH® ECG Recorder to gently peel off the liner.

Press again around the edges of the LIFEPATCH® ECG Electrode to make sure the LIFEPATCH® ECG Electrode is firmly attached to the skin.

Place the LIFEPATCH® ECG Electrode on the centre of the sternum, 2 fingers below the sternum, taking care not to touch the adhesive are. After placement, press around the edges of the LIFEPATCH® ECG Electrode to better the adherence.

4.

5.

6.

Hold the LIFEPATCH® ECG Recoder with one hand and pull the LIFEPATCH® ECG Electrode away by breaking the little handle in the LIFEPATCH® ECG Electrode.

End recording

Take the bottom end of the LIFEPATCH® ECG Electrode and gently pull it downwards and outwards to remove the LIFEPATCH® ECG Electrode.

1.

2.


INFO

Know your numbers.

GERMANYT +49 89 1301 1262 LIFEPATCH GmbHTölzer Straße 2, D 82031 GrünwaldGermany

SOUTH AFRICAT +27 82 789 0653 LIFEPATCH Pty Ltd23 Kent Avenue,Dunkeld West,2196 South Africa

AUSTRIAT +43 676 4005 209

LIFEPATCH Petrifelderstrasse,16 A 8042 GarzAustria

For further information, consult the instructions for use of the specific LIFEPATCH equipment

W www.lifepatch.eu E [email protected]

lifepatch 1 for 2lifepatch.eu/lifepatch.pdf · · 2016-06-037 ans is like the ... speed meter...

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