Know your numbers. and what they mean. Contents HOME INDEX

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2 INDEX HOME Know your numbers Contents LIFEPATCH - 1 for Patients concerns... 4 Health Management with LIFEPATCH Fitness?... 4 LIFEPATCH can answer such concerns... 4 HRV is an important indicator for fitness... 4 Factors influencing Heart rate validity... 5 Heartbeat as seen by ECG... 6 Why Heart rate validity is a Suitable Diagnostic Tool?... 7 ANS is like the driver of the Human Body... 8 and what they mean. Health Management with LIFEPATCH Balance... 9 LIFEPATCH Balance Validity of Measurement / Recording Heart Balance Autonomic Regulation Hormonal Balance CO2 Regulation (Sleep pattern) Deep Sleep Phase (nrem3) Cardiological Parameters with LIFEPATCH Cardio Atrial Fibrillation (AF Burden) Repolarisation (QTC) Standard deviation of normal heartbeats (SDNN) Health Management with LIFEPATCH Skin Preparation Sensor Hygiene and Maintenance Storing / disposal of electrodes Operating instructions For further information, consult the instructions for use of the specific LIFEPATCH equipment Know your numbers. 2

3 LIFEPATCH 1 FOR 2 LIFEPATCH - 1 for 2 One measurement caters for two different analysis Health Management Disease 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 1 for 2 1 measurement = 2 outcomes LIFEPATCH BALANCE LIFEPATCH CARDIO Application Heart fitness holistic health indicators Heart arrhythmia longterm ECG Analysis results Validation of patient s current health status and system balance Pathological status of patient s heart Medical aid Self payment Co-payment Know your numbers. 3

4 PATIENTS CONCERNS Health Management with LIFEPATCH Fitness? 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 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 Know your numbers. 4

5 FACTORS INFLUENCING HEART RATE Factors influencing Heart Rate Variability (HRV) Endogenious Breathing, blood pressure, body temperature, Hormones, illness, heart frequency Exogenic Body position, cardio rhythm, food, drugs, stress, mental and body activities, environment Constitutional Age, gender, body fat, weight, fitness, genetic makeup Know your numbers. 5

6 HEARTBEAT ECG Heartbeat as seen by ECG Depolarisation of the ventricles Depolarisation of the right & left atrium P Delay by AV-Node PR Segment QRS Complex R ST Segment Repolarisation of the ventricles Depletion of charge carrier T PR Interval Q S QT Interval Know your numbers. 6

7 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 s 24h s CO 2 Blood pressure Heart rate 1.000s 6h 10m 100s 120s Temperature 10s 120s 1s 120s Know your numbers. 7

8 ANS DRIVER ANS is like the driver of the Human Body Simple Control Loop 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. 100 km/h Acceleration or slowdown Set the throttle Read speed from gauge Meter speed Blood Pressure 100 km/h Acceleration or slowdown CO 2 Temperature On-board computer Set the throttle Meter 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. General Concept Control Loop Establish and maintain a stable state of the system Compensate for disturbances which might affect the process SET POINT CONTROLER PROCESS READING - FEEDBACK Parasympathic Sympathic 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. Know your numbers. 8

9 HEALT MANAGEMENT LF FITNESS Health Management with LIFEPATCH Balance Know your numbers. 9

10 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 Know your numbers. 10

11 LIFEPATCH LIGHT Sensor 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 Know your numbers. 11

12 LIFEPATCH FITNESS LIFEPATCH Balance Assessment of Heart-Fitness Estimation of Resilience Hormonal Balance Undesireable Respiration patterns Level of Coherence (Regeneration) Validity 51 78ms 61.3% % 8.6% Regression pnnmax CAR Regulation CO2 RSA LOCK APNOEAS STRESS 97.6% Heart Rate Autonomic Regulation Load / Recovery Cardio Estimation of severe CVDs Day Night PWR HR SD Day Night SDA SDI rmss 0.0% Af Burden 90.9 ULF pnn50 VLF LF HF Strain Regeneration 391ms QTC (HR)-i [BpM] 95.3 (HR)-i [BpM] 37.6 Active Unspecific Stress / Recovery Balance SDNN Know your numbers. 12

13 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. 880ms 859ms 879ms 881ms 869ms 876ms 880ms 878ms 871ms 68 bpm 70 bpm Know your numbers. 13

14 LIFEPATCH Balance HRV parameters DASHBOARD DASHBOARD 2 TRENDS TABULAR HRV ECG HF NORMALIZED - LOG(LF/HF) RMSSD PNNMAX CSI Ø(HR) [Bmp] 71.0 log(lf/hf) 0.0 HF normalized [%] 0.0 rmssd[ms] 50.2 pnnmax[ms] 101 CSI 1.5 HRV TOTALS Valid blocks [%] LF-i[ms 2 ] SDNN-i min(hr)[bpm] log(lf/hf)-i SDANN min(hr)-i [BpM] SDNN [ms] Regression max(hr)-i [BpM] SD1 [ms] AF Burden [%] Ø(HR) [BpM] SD2 [ms] pnn50 [%] Ø(HR)-i [BpM] SD1/SD2 ratio pnnmax [ms] HF-i [ms] rmssd [ms] TINN [ms] 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: :00: Know your numbers. 14

15 VALIDITY OF MEASURMENT Validity of Measurement / Recording Definition Meaning Action 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. The reading should preferrably be in a rangein excess of 80 to 90%. If below the above threshold the measurement should be repeated. 97.6% Validity Heart Balance Definition Meaning Action 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. 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 are low body fitness and below 40 bad fitness and potential neuropathy. > 100 maintain fitness levels. > < mobilise patient unless there are other medical conditions. < 40 mobilise patient under therapeutic supervision ms Regression pnnmax Know your numbers. 15

16 AUTONOMOCE Autonomic Regulation Definition Meaning Action 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 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. 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. 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. 61.3% CAR Hormonal Balance Definition Meaning Action 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. 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. Further analysis and consultation with a specialist such as Endocrinologist is indicated. 0.8 Regression Know your numbers. 16

17 HRV Case studies PATIENT A: VERY VITAL SIGNS 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 20:00 22:00 00:00 02:00 04:00 06:00 08:00 10:00 12:00 14:00 16:00 18:00 HEART RATE VARIABILITY - DEVIATION HEART RATE VARIABILITY - DEVIATION 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 22:00 00:00 02:00 04:00 06:00 08:00 10:00 12:00 14:00 16:00 18:00 PARASYMPATHETIC NERVE SYMPATHETIC NERVE Know your numbers. 17

18 HRV early detection of stress and the burn-out process WORK PERFORMANCE 100% 50% 1. Need to prove oneself 2. Increased engagement 3. Ignoring own health needs 4. Displacement of conflicts 5. Change in values 6. Increasing denial of problems that start to surface 7. Retreat 8. Apparent behavioral changes 9. Loss of sense of selfworth 10. Sense of emptiness 11. Depression 12. Burn-out Early indications should ALWAYS be taken seriously! As of stage 6 professional help is urgently needed! REDUCED PERFORMANCE ABSENT REBUILDING PERFORMANCE TIME 6-18 MONTHS 4-12 MONTHS 9-24 MONTHS WORK PERFORMANCE EXHAUSTION Know your numbers. 18

19 HRV Case study, female high performace athlete - exhaustion / depression h 09h 10h 11h 12h 13h 14h 15h 16h 17h 18h 19h 20h 21h 22h 23h 12 Sept 02h 03h 04h 05h 06h h 09h 10h 11h 12h 13h 14h 15h 16h 17h 18h 19h 20h 21h 22h 23h 12 Sept 02h 03h 04h 05h 06h h 09h 10h 11h 12h 13h 14h 15h 16h 17h 18h 19h 20h 21h 22h 23h 12 Sept 02h 03h 04h 05h 06h Know your numbers. 19

20 CO2 SLEEP PATTERN CO2 Regulation (Sleep pattern) Definition Meaning Action 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 CO 2 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 seconds and thus influences the heart frequency. CO2 homeostasis is maintained through automatic regulation. With a rise in CO 2 blood levels, the patients is aroused from the deep sleep phase to breathe and increases their tidal volume. The body experiences the CO 2 regulation as an emergency reaction and reducing the deep sleep phases, even in some cases waking up (Arousal). CO 2 regulation indicates what percentage of the sleep phase ANS was with the CO 2 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 CO 2 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. 22.7% CO2 Deep Sleep Phase (nrem3) Definition Meaning Action During a deep sleep phase the ANS syncronises the heart beats to conserve energy and thus optimises the exchange of oxygen / CO 2. 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. 8.6% RSA lock Know your numbers. 20

21 HRV Case study, good as opposed to bad sleep patterns 22h 23h 8 April 01h 02h 03h 04h 05h 06h 07h Know your numbers. 21

22 HRV Case study, from depressive to recovery MAY 2013 Power: 5859 ms 2 VLF: 2313 ms 2 LF: 2256 ms 2 HF: 859 ms 2 ø HR: 79 bpm pnn50 Schlaf: 47% 07h 08h 09h 10h 11h 12h 13h 14h 15h 16h 17h 18h 19h 20h 21h 22h 23h 29 May 02h 03h 04h 05h MARCH 2014 Power: 6665 ms 2 VLF: 3350 ms 2 LF: 1862 ms 2 HF: 836 ms 2 ø HR: 76 bpm pnn50 Schlaf: 41% 07h 08h 09h 10h 11h 12h 13h 14h 15h 16h 17h 18h 19h 20h 21h 22h 23h 29 March 02h 03h 04h 05h JUNE 2014 Power: 9257 ms 2 VLF: 5023 ms 2 LF: 2323 ms 2 HF: 1095 ms 2 ø HR: 70 bpm pnn50 Schlaf: 52% 07h 08h 09h 10h 11h 12h 13h 14h 15h 16h 17h 18h 19h 20h 21h 22h 23h 29 June 02h 03h 04h 05h Know your numbers. 22

23 HRV Case study, alcohol at play 0.40 HRV POWER SPEKTROGRAM [Hz] h 08h 09h 10h 11h 12h 13h 14h 15h 16h 17h 18h 19h 20h 21h 22h 23h 19 May 02h 03h 04h 05h HR TREND No alcohol in the evening ø HR Night: 63 BPM ø HR day: 86 BPM Power Night: 9437 ms 2 [BpM] HRV POWER SPEKTROGRAM [Hz] h 08h 09h 10h 11h 12h 13h 14h 15h 16h 17h 18h 19h 20h 21h 22h 23h 29 June 02h 03h 04h 05h HR TREND Alcohol in the evening ø HR Night 83 BPM ø HR day : 89 BPM Power Night: 1355 ms 2 [BpM] Know your numbers. 23

24 CARDIOLOGICAL PARAMETERS Cardiological Parameters with LIFEPATCH Cardio Know your numbers. 24

25 ATRIAL Atrial Fibrillation (AF Burden) Definition Meaning Action 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. Patient has the risk of atrial fibrillation and may experience subsequent complications. If present and after elimination of nonpathological 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%. 0.0 Af Burden Repolarisation (QTC) Definition Meaning Action 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. 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 > 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! 391 QTC Know your numbers. 25

26 STANDARD DEVIATION Standard deviation of normal heartbeats (SDNN) Definition Meaning Action 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. Range Meaning < 50 ms extremely low > 50 < 100 ms low > 100 < 180 ms normal > 180 ms above normal for athletes otherwise signal for arrhythmia Value of < 50 ms signals a lowered LVEF and consultation with a cardiologist is recommended ms repeat measurement within two weeks SDNN Know your numbers. 26

27 HEALTH MANAGEMENT WITH LP Health Management with LIFEPATCH Know your numbers. 27

28 SKIN PREP Skin Preparation 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 Sensor Hygiene and Maintenance 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 Storing / disposal of electrodes 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 Know your numbers. 28

29 OPERATING INSTRUCTIONS Operating instructions Starting recording End recording 1. Shave off any hair and clean the skin, ensure it s dry where the LIFEPATCH will be placed. 4. 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. 1. Take the bottom end of the LIFEPATCH ECG Electrode and gently pull it downwards and outwards to remove the LIFEPATCH ECG Electrode 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. Pull the snip under the LIFEPATCH ECG Recorder clockwise around the LIFEPATCH ECG Recorder to gently peel off the liner. 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. 3. 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. 6. Press again around the edges of the LIFEPATCH ECG Electrode to make sure the LIFEPATCH ECG Electrode is firmly attached to the skin. Know your numbers. 29

30 INFO For further information, consult the instructions for use of the specific LIFEPATCH equipment W E info@lifepatch.eu GERMANY T LIFEPATCH GmbH Tölzer Straße 2, D Grünwald Germany SOUTH AFRICA T LIFEPATCH Pty Ltd 23 Kent Avenue, Dunkeld West, 2196 South Africa AUSTRIA T LIFEPATCH Petrifelderstrasse, 16 A 8042 Garz Austria Know your numbers.