Check Point new 09.2015 full

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Check Point™ Telemonitoring Platform

BODIES ONLINE

Check Point™ Telemonitoring Platform

Telemonitoring today

• Cardiovascular disease causes 47% of all deaths in Europe• Each year cardiovascular disease causes over 4 million deaths in Europe• In the same time biometric monitoring in cardiology, surgery, gynecology , etc, is still:

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• Multinational medical technology developent project• With mission to identify and integrate the best practices in world telemonitoring• Own telemonitoring centre with capacity of 15 000 patients simultaneously monitored• Proven track record since 2000• Specialised in innovative telemonitoring applications• Primarily focussed on telemonitoring of vital-signs• Key applications are telemonitoring of:

- ECG- SpO2- Temperature- Cardiac Events- Early Warning Score (Visensia Index)- Fetal Heart Rate- Ventilation parameters- Health and fitness testing (Vital-Vision)

• Distribution network in Europe, Asia and United States of America• Product solution comprises monitoring equipement, servers, software and Smartphone applications• Product suite certified by CE, FDA, FCC and PTCRB

What is Check Point Cardio

• Multinational medical technology developent project• With mission to identify and integrate the best practices in world telemonitoring• Own telemonitoring centre with capacity of 15 000 patients simultaneously monitored• Proven track record since 2000• Specialised in innovative telemonitoring applications• Primarily focussed on telemonitoring of vital-signs• Key applications are telemonitoring of:

- ECG- SpO2- Temperature- Cardiac Events- Early Warning Score (Visensia Index)- Fetal Heart Rate- Ventilation parameters- Health and fitness testing (Vital-Vision)

• Distribution network in Europe, Asia and United States of America• Product solution comprises monitoring equipement, servers, software and Smartphone applications• Product suite certified by CE, FDA, FCC and PTCRB

We offer healthcare providers an all-encompassing solution for remote monitoring and diagnostics oftheir patients to:

• Improve patient comfort by keeping them in their home environment longer without risk• Reduce number of complication events in post-operative and post-clinical stage• Reduce the workload and increase cost efficiency of telemonitoring services by remote monitoring• Contribute to improving overall health by offering health and fitness testing services• Increase self-confidence in patients, reduce stress• Reduce expences for logistics, hospital stay, surgery invasions , of the state or private health systems

Proposition

We offer healthcare providers an all-encompassing solution for remote monitoring and diagnostics oftheir patients to:

• Improve patient comfort by keeping them in their home environment longer without risk• Reduce number of complication events in post-operative and post-clinical stage• Reduce the workload and increase cost efficiency of telemonitoring services by remote monitoring• Contribute to improving overall health by offering health and fitness testing services• Increase self-confidence in patients, reduce stress• Reduce expences for logistics, hospital stay, surgery invasions , of the state or private health systems

Solutions and application

TelemonitoringVital-Signs Telemonitoring Fetal Heart Rate Telemonitoring 12-lead ECGTelemonitoringVital-Signs Telemonitoring Fetal Heart Rate Telemonitoring 12-lead ECG

Telemonitoring Ventilation Heart attack Index Score Health & Fitness testing

Technical overview PC software

Telemonitoring

Configuration anddata download

Alerts

WEB portalFile Server

Hardware unitWith built-in modem

and SIM card *

Telemonitoring

All data available online

Patient Server

Alerts

own monitoringown monitoringcentrecentre

PLATFORM 1Check Point universal offer

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Partnership Check Point – Vital ConnectUSA

• One of the most fast developing telemedicine R&D companies in US

• Company is developing basic, but affordable system enabling a remotetransmission of ECG from patients to doctors• Simple, easy-to wear, working with a Android smartphone• Extremely long batery life – up to 7 days without a re-charge!

• Company is developing basic, but affordable system enabling a remotetransmission of ECG from patients to doctors• Simple, easy-to wear, working with a Android smartphone• Extremely long batery life – up to 7 days without a re-charge!

• Only 85 g. weight•Together with Check Point, in 2015 is developed a complete system for cardiactelemonitoring, including

- 1-lead lifestream ECG- Temperature- Respiration- Body posture- Pulse- Heart rate and variability- Cardiac Events- GPS

Simple, easy to wear, modern

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Remote ECG diagnosis and consultation

Data transfer Data visualizing Diagnose

Vital connect is certified as a complete solution, including data transmission, server system, software andSmartphone applications for real-time monitoring of patient’s vital signs and ECG waveforms.

Vital connect is a IIb medical device and is allowed for use in the Intensive Care Unit and Operating Theater.

The products are allowed for sale in Europe, USA, Asia, EMEA and Africa.

The products are designed and manufactured by ISO standards for medical products (ISO 9001 and ISO 13485).

Vital Connect comes with the following certificates:

CE-mark (0344) FDA 510(k) approval for the Americas CAMDCAS approval for Canada FCC approval for the radio transmission for USA and Canada PTCRB approval for the cellular transmission SAR approval for body worn telecom units

Certifications

Vital connect is certified as a complete solution, including data transmission, server system, software andSmartphone applications for real-time monitoring of patient’s vital signs and ECG waveforms.

Vital connect is a IIb medical device and is allowed for use in the Intensive Care Unit and Operating Theater.

The products are allowed for sale in Europe, USA, Asia, EMEA and Africa.


Vital Connect comes with the following certificates:


PLATFORM 2Check Point premium offer

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Partnership with Techmedic International - Nederlands• Dutch based medical technology development company• Operating since 2000-Th• Specialised in innovative telemonitoring applications• Primarily focussed on telemonitoring of vital-signs• Carrier of all world standards for telemedicine and a lot of patents• The only system, ensuring real time data• Profound automatical analyses of vital signs, when the doctor can program the allert,

individually for each patient• Key applications are telemonitoring of:

- ECG- SpO2- Temperature- Cardiac Events- Early Warning Score (Visensia Index)- Fetal Heart Rate

• Dutch based medical technology development company• Operating since 2000-Th• Specialised in innovative telemonitoring applications• Primarily focussed on telemonitoring of vital-signs• Carrier of all world standards for telemedicine and a lot of patents• The only system, ensuring real time data• Profound automatical analyses of vital signs, when the doctor can program the allert,

individually for each patient• Key applications are telemonitoring of:

- ECG- SpO2- Temperature- Cardiac Events- Early Warning Score (Visensia Index)- Fetal Heart Rate

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Dyna-Vision™ Applications

TelemonitoringSystem

Resting ECG

CardiacEvents

SpO2 andPulse Rate

Dyna-Vision™ Telemonitoring System is used for avariety of applications in the medical andparamedic environment.

The core application is the Dyna-Vision™Telemonitoring system.

Simple add the plug-in(s) for the application(s)of choice;

DV-REST-ECG DV-VIS-MON DV-RTP-MON DV-EVENT-MON DV-FHR-MON DV-HVM-MON DV-SPO2-MON

TelemonitoringSystem Real-time

PatientMonitoring

ContinuousEarly

WarningScore

Fetal HeartRate /

UterineContractions

HomeVentilatedPatients

Dyna-Vision™ Telemonitoring System is used for avariety of applications in the medical andparamedic environment.

The core application is the Dyna-Vision™Telemonitoring system.

Simple add the plug-in(s) for the application(s)of choice;

DV-REST-ECG DV-VIS-MON DV-RTP-MON DV-EVENT-MON DV-FHR-MON DV-HVM-MON DV-SPO2-MON

Dyna-Vision™ with Internal Battery = one of mostendurable hardwares, designed for multi-renting!

Resting ECG – Telemedicine System

Dyna-Vision™ unit withbuilt-in SIM card and

internal modemconnected to the patient

Dyna-Vision™secured

telemedicineserver

PC with Dyna-Vision™ softwareconnects to the telemedicine server PDF reports and online

storage in ElectronicHealth Record

Vital Signs Tele-monitoring Display

All data collected by Dyna-Vision™ is used in high-level reports Reports are stored in PDF or FDA-XML format The reports can be send to others by secured connection via the server Dyna-Vision™ applications can output data to EHR The reports present high-resolution medical data in superb quality graphs Interconnectivity of data with other software / systems (XML/PDF/others)

Reporting

Example of reports

Dyna-Vision™ Connected to Patient

3-Lead 3-Lead patch 12-Lead patch

Dyna-Vision™ with Mobile Patient

Dyna-Vision™ Telemedicine System is certified as a complete solution, including data transmission, server system,software and Smartphone applications for real-time monitoring of patient’s vital signs and ECG waveforms.

Dyna-Vision™ Unit is a IIb medical device and is allowed for use in the Intensive Care Unit and Operating Theater.

Techmedic International is audited annually by a notified body. The products are allowed for sale in Europe, USA,Asia, EMEA and Africa.


Dyna-Vision™ comes with the following certificates:


Certifications

Dyna-Vision™ Telemedicine System is certified as a complete solution, including data transmission, server system,software and Smartphone applications for real-time monitoring of patient’s vital signs and ECG waveforms.

Dyna-Vision™ Unit is a IIb medical device and is allowed for use in the Intensive Care Unit and Operating Theater.

Techmedic International is audited annually by a notified body. The products are allowed for sale in Europe, USA,Asia, EMEA and Africa.


Dyna-Vision™ comes with the following certificates:


2002: Herman Wijffels Innovation Award for new Heart-Lung Machine design2004: Patent granted for “Emergency Warning System”2005: Patent granted for “New Method for Respiration Monitoring”2006: Patent granted for “New Clamping Method for Mounting Equipment”2007: Patent granted for “Work-of-Breathing Detection Method”2009: Patents filed for “Real-time Remote Patient Monitoring using Integrated Cellular Technology”2010: Nominated for the “Global GSMA m-Health Award – due February 20112010: Finalists for the “International Business Award – due April 20112011: Received the “Frost & Sullivan Excellence Award for Remote Patient Monitoring”

Awards and Patents

2002: Herman Wijffels Innovation Award for new Heart-Lung Machine design2004: Patent granted for “Emergency Warning System”2005: Patent granted for “New Method for Respiration Monitoring”2006: Patent granted for “New Clamping Method for Mounting Equipment”2007: Patent granted for “Work-of-Breathing Detection Method”2009: Patents filed for “Real-time Remote Patient Monitoring using Integrated Cellular Technology”2010: Nominated for the “Global GSMA m-Health Award – due February 20112010: Finalists for the “International Business Award – due April 20112011: Received the “Frost & Sullivan Excellence Award for Remote Patient Monitoring”

International Business Award 2010

MONITORING, DIAGNOSTICS,EMERGENCY REACTION

Check Point Tele medicine center

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What is Medical center Check Point?• Created 2010• Over 9500 patients files with different telemedicine systems• 24/7 monitoring of cardiac and gynecology data• 6 doctors, 10 nurses• With automatic data analyses , up to 15 000 patients capacity for

simultaneously monitoring• Own ERP for management, first reaction within 2 minutes standard• Certified by suppliers for 13 485 and ISO 9001 standards• Know-how for spreading design and structure in other countries

• Created 2010• Over 9500 patients files with different telemedicine systems• 24/7 monitoring of cardiac and gynecology data• 6 doctors, 10 nurses• With automatic data analyses , up to 15 000 patients capacity for

simultaneously monitoring• Own ERP for management, first reaction within 2 minutes standard• Certified by suppliers for 13 485 and ISO 9001 standards• Know-how for spreading design and structure in other countries

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CP center

• Telemedical centre has emergency operators,administration operator and call operator forregistration, observation and contact with thepatient, physicians and emergency centers

• This is the place where heart rate and itsvariability, rhythm and conduction disorders areanalyzed, together with physical activity of thepatient, allowing some conclusions abouthis/her current cardiovascular condition andrisk.

• In case a predefined critical condition is met,short messages (SMS) are generated and sent tothe medical specialist, or/and call to the patient,his physician or emergency centre are initiated.

• Telemedical centre has emergency operators,administration operator and call operator forregistration, observation and contact with thepatient, physicians and emergency centers

• This is the place where heart rate and itsvariability, rhythm and conduction disorders areanalyzed, together with physical activity of thepatient, allowing some conclusions abouthis/her current cardiovascular condition andrisk.

• In case a predefined critical condition is met,short messages (SMS) are generated and sent tothe medical specialist, or/and call to the patient,his physician or emergency centre are initiated.

www.checkpointcardio.com

General statistics 2010-2014• Total number of patients telemonitored with diferent checkpoint cardio systems =

9500• Mean period for telemonitoring – 5.34 days• Indications:

– Rhythm disorders – 74%– Ischemia detection – 26%

• Detection of a new condition during telemonitoring (undocumented rhythm disorder,evidence of ischemia) – 76.7%

• Telemonitoring resulting in therapy modification / change (either because of a newdiagnosis or because telemonitoring revealed that previous therapy was inappropriate/ ineffective for the present patient condition) – 84.6%

• Urgent hospitalization for a condition detected during telemonitoring – 33.6%; meantime from detection to hospitalization – 2 hours;

• Patient driven telemonitoring discontinuation due to side effects – 0.6%

• Total number of patients telemonitored with diferent checkpoint cardio systems =9500

• Mean period for telemonitoring – 5.34 days• Indications:

– Rhythm disorders – 74%– Ischemia detection – 26%

• Detection of a new condition during telemonitoring (undocumented rhythm disorder,evidence of ischemia) – 76.7%

• Telemonitoring resulting in therapy modification / change (either because of a newdiagnosis or because telemonitoring revealed that previous therapy was inappropriate/ ineffective for the present patient condition) – 84.6%

• Urgent hospitalization for a condition detected during telemonitoring – 33.6%; meantime from detection to hospitalization – 2 hours;

• Patient driven telemonitoring discontinuation due to side effects – 0.6%

Indications. Atrial fibrillation.• Patients with suspected but undiagnosed atrial fibrillation:

– Clinical symptoms such as palpitations or dyspnoea should trigger ECGmonitoring to demonstrate AF, or to correlate symptoms with the underlyingrhythm - IIaB.

– Additional ECG monitoring should be considered for detection of ‘silent’ AF inpatients who may have sustained an AF-related complication - IIaB.

– It has been estimated that 7 day Holter ECG recording or daily and symptom-activated event recordings may document the arrhythmia in around 70% of AFpatients, and that their negative predictive value for the absence of AF isbetween 30 and 50%.

• Patients with known atrial fibrillation:– When arrhythmia or therapy-related symptoms are suspected, ECG monitoring

should be considered - IIaC.

• Patients with suspected but undiagnosed atrial fibrillation:– Clinical symptoms such as palpitations or dyspnoea should trigger ECG

monitoring to demonstrate AF, or to correlate symptoms with the underlyingrhythm - IIaB.

– Additional ECG monitoring should be considered for detection of ‘silent’ AF inpatients who may have sustained an AF-related complication - IIaB.

– It has been estimated that 7 day Holter ECG recording or daily and symptom-activated event recordings may document the arrhythmia in around 70% of AFpatients, and that their negative predictive value for the absence of AF isbetween 30 and 50%.

• Patients with known atrial fibrillation:– When arrhythmia or therapy-related symptoms are suspected, ECG monitoring

should be considered - IIaC.

Management of Atrial Fibrillation, ESC, Focused Update from 2012; Guidelines for themanagement of atrial fibrillation, 2010

Indications. Sudden cardiac death.• Patients with primary risk factors of SCD :

– Patients experienced cardiac arrest and/or hemodynamically significant sustained ventricular tachycardia;– Patients experienced myocardial infarction;– Patients with syncope episodes ;– Patients with systolic left ventricular dysfunction (ejection fraction of less than 40%) and/or episodes of unstable

ventricular tachycardia, established by instrumental examinations;With patients with the above listed high risk factors, there is high possibility of recurrence of fatal ventricular rhythm

disorders with the development of acute heart failure and sudden cardiac death.Recommended monitoring period : 7-10 days, four times a year.

• Patients with secondary risk factors of SCD :– Patients with left ventricular hypertrophy;– Patients with hypertension;– Patients with hyperlipidemia;– Patients with diabetes;– Patients with hyper sympathicotonia;– Patients with obesity;– Smokers;– Patients regularly using alcohol.

Recommended monitoring period : 7-10 days, two times a year.

• Patients with primary risk factors of SCD :– Patients experienced cardiac arrest and/or hemodynamically significant sustained ventricular tachycardia;– Patients experienced myocardial infarction;– Patients with syncope episodes ;– Patients with systolic left ventricular dysfunction (ejection fraction of less than 40%) and/or episodes of unstable

ventricular tachycardia, established by instrumental examinations;With patients with the above listed high risk factors, there is high possibility of recurrence of fatal ventricular rhythm

disorders with the development of acute heart failure and sudden cardiac death.Recommended monitoring period : 7-10 days, four times a year.

• Patients with secondary risk factors of SCD :– Patients with left ventricular hypertrophy;– Patients with hypertension;– Patients with hyperlipidemia;– Patients with diabetes;– Patients with hyper sympathicotonia;– Patients with obesity;– Smokers;– Patients regularly using alcohol.

Recommended monitoring period : 7-10 days, two times a year.

Indications. Bradyarrhythmia and syncope.

• When an intermittent bradyarrhythmia is suspected but not proven, the suspicion should becorroborated by an ECG documentation of bradyarrhythmia or, alternatively, by laboratorytesting.

• Since most patients with syncope have infrequent symptoms, recurring over months or years,long-term ECG monitoring is often necessary to establish a diagnosis

• When an intermittent bradyarrhythmia is suspected but not proven, the suspicion should becorroborated by an ECG documentation of bradyarrhythmia or, alternatively, by laboratorytesting.

• Since most patients with syncope have infrequent symptoms, recurring over months or years,long-term ECG monitoring is often necessary to establish a diagnosis

2013 ESC Guidelines on cardiac pacing and cardiac resynchronization therapy

Other telemonitoring Indication Recommendedtime period

History of undocumented arrhythmia 7-14 days

Suspected but undiagnosed AF 5-7 days

Rhythm disturbances in mitral valve prolapse patients 5-7 days

Rhythm evaluation after antiarrhythmic therapy initiation 5 days

Evaluation of heart rate in patients with permanent AF or bradyarryhtmia 3 days

Heart rate control after cardiac surgery 15 days

Heart rate and rhythm evaluation after ablation therapy 7 -15 days

Detection of “silent” AF in stroke patients or after peripheral embolic event 7 - 14 days

High risk patients for ventricular arrhythmia or sudden cardiac death (long QT syndrome, ARVD,Brugada syndrome, ventricular preexcitation, MI patients with LV dysfunction etc)

14 - 28 days

First degree relatives of patients with congenital heart diseases associated with high risk for SCD 10-14 days

Syncope / presyncope, dizziness 7 days

Active / elite sport with extreme physical stress 3 days

High risk professional occupation 5 days

Verification

• Validation of the system was performed at National Cardiology institute in WARSAW,Poland and National cardiological hospital, Sofia Bulgaria.

• We evaluated 60 patients, 22 (37%) of them female, mean age – 58 ± 8 y, applyingsimultaneously standard Holter ECG and Checkpoint system.

• Two different comparisons were performed:– ECG with standard 12-lead ECG– Checkpoint Holter with standard ECG Holter

• The design of the study included simultaneous Holter ECG and Checkpoint systemmonitoring for at least 20 hours.

• The protocol of the study included also 5 simultaneous ECG recordings (Checkpointand standard ECG) at baseline, 1st, 2nd, 6th hour and at the end of the monitoringperiod.

• Patient compliance during the monitoring period was excellent.

• Validation of the system was performed at National Cardiology institute in WARSAW,Poland and National cardiological hospital, Sofia Bulgaria.

• We evaluated 60 patients, 22 (37%) of them female, mean age – 58 ± 8 y, applyingsimultaneously standard Holter ECG and Checkpoint system.

• Two different comparisons were performed:– ECG with standard 12-lead ECG– Checkpoint Holter with standard ECG Holter

• The design of the study included simultaneous Holter ECG and Checkpoint systemmonitoring for at least 20 hours.

• The protocol of the study included also 5 simultaneous ECG recordings (Checkpointand standard ECG) at baseline, 1st, 2nd, 6th hour and at the end of the monitoringperiod.

• Patient compliance during the monitoring period was excellent.

Mateev H, Simova I, Katova T, Dimitrov N. ISRN Cardiology 2012; article ID 192670, 8 pages

Verification – ECG comparison

• We analyzed ECG recordings considering 5 parameters: heart rhythm(sinus rhythm, atrial fibrillation, atrial flutter), HR, SVEB, VEB and significantpauses (> 2500 ms).

• For these parameters we have reported the percentage of coincidence(accordance) between Checkpoint ECG and standard ECG.

• We have performed 297 standard ECG recordings and 297 CheckpointECGs (mean number of ECGs per patient – 4.95 for each mode ofrecording).

• We found a very high coincidence rate of 99.3% when Checkpoint derivedECGs were compared with standard ECGs.

• We analyzed ECG recordings considering 5 parameters: heart rhythm(sinus rhythm, atrial fibrillation, atrial flutter), HR, SVEB, VEB and significantpauses (> 2500 ms).

• For these parameters we have reported the percentage of coincidence(accordance) between Checkpoint ECG and standard ECG.

• We have performed 297 standard ECG recordings and 297 CheckpointECGs (mean number of ECGs per patient – 4.95 for each mode ofrecording).

• We found a very high coincidence rate of 99.3% when Checkpoint derivedECGs were compared with standard ECGs.

Mateev H, Simova I, Katova T, Dimitrov N. ISRN Cardiology 2012; article ID 192670, 8 pages

Verification – automatic analysis comparison with Holter ECG

Parameter ECG Holter Checkpointsystem

Correlation ICC p value

Average HR 75 ± 14 74 ± 16 0.85 0.91 < 0.001

Maximal HR 130 ± 33 121 ± 19 0.42 0.48 0.017

Minimal HR 54 ± 14 48 ± 13 0.77 0.84 < 0.001Minimal HR 54 ± 14 48 ± 13 0.77 0.84 < 0.001

% time in tachycardia 10.2 ± 16.3% 9 ± 15.1% 0.59 0.72 < 0.001

VEB single 456 ± 618 363 ± 722 0.43 0.58 0.02

VEB couplets 109 ± 258 76 ± 195 0.75 0.47 0.01

SVEB single 815 ± 1002 315 ± 678 0.68 0.59 0.001

SVEB couplets 105 ± 218 33 ± 106 0.19 0.24 0.05

Typical case examplesTypical case examples


Supraventricular Ectopic beat


Ventricular ectopic beats - bigeminy


Ventricular ectopic beats - trigeminy


Interpolated venticular ectopic beats


Ventricular ectopic beats followed by ventricular tachycardia


Atrial Flutter


Atrial fibrillation


Registration of reestablishing of sinus rhythm on patient with Atrialfibrillation


AV block 2 degree; 2nd type with conductivity in AV 2:1


Patient Cases


CASE 1: Patient with AVNRT detected during the telemedicalobservation

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Case 4 : 55 years old patient• Hospitalized with an ischemic stroke, embolic etiology was sugessted, but an embolic source was

not found during diagnostic work out.• In order to detect asymptomatic episodes of AF telemedical device was installedJust on the 4th supervision day an asymptomatic AF episode was detected.• Telemonitoring was ended – diagnosis secured;• Anticoagulation therapy was initiated for secondary prophylaxis – prevention of stroke and

systemic embolism.

• Admitted at hospital with inferior STEMI• SCAG revealed RCA occlusion and pPCI was performed

Case 6: 72-year-old man

• At discharge a Telemedical device was installed.• Sinus rhythm with supraventricular ectopic beats.

• On the 1st day of observation a long-lasting (3 and a half hours) episode oftachyarrhythmia – AF was registered.

• That required initiation of antiarrhythmic therapy and triple antithrombotictherapy (anticoagulation included).

• Admitted at hospital with initial diagnosis Unstable Angina;• During hospital stay no objective evidence of myocardial necrosis or inducible ischemia

was found• At discharge Telemedical device was installed; telemonitoring revealed multiple

prolonged episodes of significant ST segment depression in modified V5 lead.

Case 7: 77-year-old man

• A decision was made for SCAG• Single-vessel CAD with a significant LCx lesion• PCI with LCx stenting was performed

Check Point new 09.2015 full

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