A

PROJECT REPORT
ON

Digital Holter and its services (LightWave and CardiaConnect)

Loop Holter

BY
Ms. Kasturi Sonawane

IN PARTIAL FULFILMENT FOR THE DEGREE

OF

INTEGRATED MASTER OF TECHNOLOGY IN BIOENGINEERING

SUBMITTED TO

MIT School of Bioengineering Sciences & Research,

A Constituent Unit of MIT-ADT University, Pune.

2017 - 2022
 A
PROJECT REPORT
ON

Digital Holter and its services (LightWave and CardiaConnect)

Loop Holter

BY
Ms. Kasturi Sonawane

Under the guidance of

Yashwant Samant (CEO-Nasan Medical Electronics Pvt Ltd.)
Manjiri Date (HOD - Design and development department- Nasan Medical
Electronics Pvt Ltd.)

IN PARTIAL FULFILMENT FOR THE DEGREE

OF
INTEGRATED MASTER OF TECHNOLOGY IN BIOENGINEERING

SUBMITTED TO
MIT School of Bioengineering Sciences & Research,
A Constituent Unit of MIT-ADT University, Pune.

2017- 2022

ii
iii
 DECLARATION

I declare that this report reflects my original work about the subject in my own words. I have
sufficiently cited and referenced the original sources, referred or considered in this work. I have
not plagiarized or submitted the same work for the award of any other degree, plagiarism report
is attached here with. I also declare that I have adhered to all principles of academic honesty
and integrity and have not misrepresented or fabricated or falsified any idea/data/fact/source in
my submission. I understand that any violation of the above will lead to disciplinary action by
the Institute.

Kasturi Sonawane

Date: 31st May, 2022

Place: MIT School of Bioengineering Sciences & Research, Loni Kalbhor, Pune.

iv
 ACKNOWLEDGMENT

A project serves as a link between the theoretical and practical aspects of labour. I completed
my final year project with this attitude. I am forever indebted to my advisors, Mr. Yashwant
Samant (CEO of Nasan Medical Electronics Pvt Ltd.) and Mrs. Manjiri Date (HOD - Design
and development department- Nasan Medical Electronics Pvt Ltd.), Mrs. Vasudha Pawar
(Senior Engineer – D&D department) and Miss. Sadhana Khedkar (Junior Hardware
Design Engineer – D&D department) for providing me the opportunity for working on this
project. Without their great guidance, encouragement, feedback, and patience this work could
not be completed.

I would like to express my deep and sincere gratitude to Dr. Renu Vyas (Head of Department-
MIT School of Bioengineering Sciences and Research) who has been supportive of my career
goals and worked actively to provide me with the protected academic time to pursue those
goals. As my teacher, she has taught me more than I could ever give her credit for. I am grateful
to all of those with whom I have had the pleasure to work during this period and other related
project. In addition, I would like to thank all the professors in my department who have been
guiding me in the past 4 years. Personally, I would like to thank all the members from my
company who have supported me in every step to build my knowledge. I perceive this
opportunity as a big milestone in my career development. I will strive to use gained skills and
knowledge in the best way possible way, and I will continue to work on their improvement in
order to attain desired career objectives.

v
 ABSTRACT

Over the period of 1 year, I have done multiple tasks at this organization. My first task was to
understand and become conversant with every product and know its mechanism in detail and
later, we were asked to test and do the QA (Quality Analysis) of each and every medical product
which is being manufactured in the company. My job was to fulfil the quality of product and
requirement of customer. In the whole production line, our work plays important role while
delivering a product to the customer. Our entire work is driven by multiple systems. Every
process has steps which are standardized by ISO. The tests to be performed are written in job
guide which has its standard format. Multiple problems are come up during QA and testing of
the product. All these problems which we could solve was increasing my problem-solving
ability. This problem-solving ability was giving me an opportunity to get core knowledge of
the products. The project titles are LightWave, CardiaConnect and Loop Holter. Lightwave is
a 3-channel Digital Holter test, connecting doctors in cities to a larger crowd of patients in
remote villages through app, thereby reaching out to the unreached. Junior doctor/technicians
in remote locations get well equipped clinic and senior doctors gets a larger crowd of patients.
Patients need not travel to urban areas for treatment, thereby ensuring comfort of cardiac
patients by saving their time, energy and money. Many times, doctors ask the technician to
learn the software. but if technician leaves, the doctor is in a fix. CardiaConnect is a new range
of Holter service, that includes 24Hr Analysis (LightWave) and AF (Atrial Fibrillation)
Analysis. Here, cardiologist will get 24 hours data from our Holter. With just one click, data
will be sent to Nasan server. Nasan server will send the patient data to AF server. Based on the
data, a report is generated and is sent to the respective doctor via Nasan server. Loop Holter or
event recorders that hold ‘loop memory’ for almost 7 days. It analyses the ECG continuously
by retaining the information pertaining to relevant arrhythmias that are automatically detected.
I also got the opportunity to learn and study about EECP (Enhanced External Counter Pulsation)
which is a US FDA approved scientific and a non-invasive therapy to lower the number
and intensity of angina episodes. Also known as Natural Bypass. EECP (Enhanced
External Counter pulsation) is a treatment usually preferred for CHD patients. There are many
techniques involve curing heart related deformities such CABG (coronary artery bypass
grafting), PTCA (percutaneous transluminal coronary angioplasty), Gene therapy etc. EECP
involves mechanical assembly which uses three sets of pneumatic cuffs placed at lower limb.
Inflation and deflation of cuffs is synchronized with each heartbeat. The inflation and deflation
of cuffs occur sequentially so that blood flows from lower part of the body to the upper part of
vi
body. Blood in the leg pushed forcefully to the upper part of body so that it gives collateral
channels to the blood vessels.

Keywords: Quality analysis, medical product, digital Holter, LightWave, CardiaConnect,

server, Loop Holter, angina episodes, EECP.

vii
 CONTENTS

Certificate iii
Declaration iv
Acknowledgment v
Abstract vii
Contents ix
List of Figures xi

1. Introduction and Literature review

1.1 Objectives 2
1.2 Product Information 5
1.3 Quality Management System EN ISO 13485 Certification 6
1.3.1 Benefits of EN ISO 13485 Certification 6
1.3.2 Risk Management System ISO 14971:2019 Certification 7
1.4 LightWave – A brief introduction 8
1.4.1 Benefits 8
1.4.2 Logistic 9
1.4.3 Concept 9
1.4.4 Why is it beneficial to the doctors? 11
1.5 CardiaConnect 11
1.5.1 Benefits 11
1.5.2 What does Atrial Fibrillation mean? 12
1.5.3 What causes Atrial Fibrillation? 13
1.6 Loop Holter – Overview 14
1.6.1 Basic Principle of Loop Recorder 15
1.6.2 Why is the Loop Recorder needed? 16
1.6.3 Pros and Cons of Loop Recorder 17
1.6.4 Risks 17
1.7 ECP – External Counter pulsation – Overview 18
1.7.1 Basic Principle of ECP 19
1.7.2 Importance of ECP 20
1.7.3 Who should not be considered for ECP therapy? 20
1.7.4 Application of ECP other than Angina 20

viii
 1.7.5 Effects of ECP other than cardiovascular disease 21
1.7.5.1 Brain Ischemia (Cerebrovascular disease) 21
1.7.5.2 Effects of ECP on cerebrovascular disease 21
1.7.5.3 Diabetes Neuropathy 22
1.7.5.4 Fundus Diabeticus 22
1.7.5.5 Effects of ECP on diabetes and its adverse diseases 23
1.7.5.6 Ischemic Eye disease 23
1.7.5.7 Effects of ECP on Ischemic Eye disease 23
1.7.6 Benefits of ECP therapy 24
1.7.7 Possible benefits of ECP 24
1.8 Regulatory Affairs – Overview 25
1.8.1 What are Regulatory Affairs? 26
1.8.2 Job of Regulatory Affairs department 26
1.8.3 Marketing Applications 27
1.8.4 Post Market Surveillance 27
1.8.5 Medical Devices and International Regulatory Affairs 27

2. Methodology
2.1 LightWave Holter Installation/Initialization 28
2.1.1 Steps for downloading data 30
2.1.2 Patient Preparation 30
2.1.3 Electrode Placement 31
2.1.4 Basic Working of the LightWave Holter 39
2.2 Basic Working of the CardiaConnect unit 42
2.2.1 Steps to follow when 24Hr Analysis option is selected 43
2.2.2 Steps to follow when AF Analysis option is selected 44
2.3 Current Status of Loop Holter 44
3. Results, Discussion and Conclusion

3.1 Overall Understanding 47

4. Ref. and bibliography 49

ix
 LIST OF FIGURES

Fig. Page
Details
No. No.
1.1 Nasan Logo 1
1.2 ST Win 2
1.3 Bed side monitor 3
1.4 Digital Holter 3
1.5 SIMUL-G unit 4
1.6 Biphasic Defibrillator 5
1.7 LightWave unit 7
1.8 Flow of the scheme 10
1.9 Atrial Fibrillation 12
1.10 Main characteristics of Different Cardiac Monitoring devices 14
1.11 ECP Setup 18
1.12 Blood flow in the coronary artery 20
2.1 Error while downloading Holter data 29
2.2 LightWave Unit 29
2.3 Patient cable 30
2.4 Electrode Placement 31
2.5 LightWave registration form 32
2.6 LightWave software interface 33
2.7 Configure Window 33
2.8 Enter the device number 34
2.9 Download button 34
2.10 Patient details window 35
2.11 Downloading the recorded data from the unit 35
2.12 Data downloaded successfully 35
2.13 Data uploaded successfully to the server 36
2.14 App interface 36
2.15 List of reports 37
2.16 Report 38
2.17 Navigating through the report 39
2.18 Adding pages to print and writing comments 40
2.19 Configure window 40
x
2.20 Hospital details 41
2.21 Enter device number 41
2.22 Patient details 42
2.23 Data uploaded successfully 42
2.24 Server options 43
2.25 Data uploaded successfully on server 43
2.26 24Hr Analysis data upload 44
2.27 AF Analysis data upload 45
3.1 Maximum HR page 46
3.2 Minimum HR page 46
3.3 47

xi
 Section 1: Introduction and Literature review

Figure: 1.1 Nasan logo

Nasan Medical Electronics, set in Pune, is a company that develops, manufactures, and trades
medical equipment. For nearly 3 decades, NASAN has been a persistent player in cardiology-
centric medical equipment. Nasan contains a patronage of around 10,000 people. Nasan was
additionally awarded associate ISO 13485 certificate in 2016. Nasan's in-depth business line
includes indigenously created advanced instrumentality like Central monitoring Systems, TMT
Machines, and Patient Monitors, furthermore as Biphasic Defibrillators and Digital Holter
Recorders, that are manufactured in-house from the scratch.

1.1 Objectives

• To study the medical equipment like Digital Holter, Defibrillators, Automated External
Defibrillator, Patient Monitor and Stress Test and their specifications and working
principle. And mainly, to learn the usage of SMD components like PCBs used in these
medical devices.

• As a Quality Assurance Engineer - To fulfill the requirement of customer and ensuring

the quality/efficacy of the manufactured product.

• As a Document Executive – To create and update the Assembly Job Guides, Job Cards,
Quality Assurance Job Guide of these manufactured products and also Risk Assessment
files for Stress test machine, Digital Holter and ECG machine.

• For Lightwave Holter – That connects doctors in cities to a larger crowd of patients in
remote areas through a simple application ensuring comfort of cardiac patients by saving
their time, energy, and money.

• For CardiaConnect Holter service – For easy diagnosis of Atrial Fibrillation (AF)
observed in cardiac patients which is based on an unchallenged algorithm developed by
a German company. This algorithm will detect and generate an AF report based on the
Holter data recorded and uploaded on the Nasan and AF server.
1
1.2 Product Information

1. ST Win- Stress Test system

Figure: 1.2 ST Win

▪ At a heart rate of more than 180 beats per minute, it's capable of providing a rock-solid
baseline.
▪ Complying with the American Heart Association's complete frequency response of 0.05
Hz to 150 Hz.
▪ Assuring you of great correlation with angiography by allowing correct determination of
ST values.
▪ With no muscular tremor or 50 cycle noise, the ECG is clear.
▪ ST - Win is a Windows-based stress test system that includes a digital signal processor
for a rock-steady baseline and outstanding data collecting and processing.
▪ At high heart rates, this device provides high-quality, crisp ECGs with no baseline drift.
It features full disclosure from beat to beat, arrhythmia detection, and automated and
manual online printing. It is possible to configure and pre-select the reports required at
any moment in any step with automatic online printing, and a report is printed once the
pre-determined phase is completed.

2
2. Bed side monitor

Figure: 1.3 Bed side Monitor

▪ Waveforms on a colour TFT panel with high resolution.

▪ Trends in graphic tabular form.
▪ Rechargeable battery built-in.
▪ A facility for interacting with a central monitoring system
▪ Portable and easy to transport.

3. Digital Holter

Figure: 1.4 Digital Holter

▪ ECG information from 3 channels over a 24-hour period is saved.

▪ 10 minutes, 20 minutes, 30 minutes, and hour of revelation
▪ Normal beat choice is done automatically or manually.
▪ The polarity of a such channel is reversed.
▪ View all channels of all beats within template's graphical record information.
▪ Editing of cardiopathy varieties of individual beats is feasible.
▪ All channels heart rate trends, known arrhythmias, and ST levels are visible.

3
▪ Maximum and minimum Heart rate, longest Pause, longest V-Tach, longest SV Tach,
longest ST episode, and highest delta ST are all accessible.
▪ 8 seconds, 1 minute, 10 minutes, 20 minutes, 30 minutes, and hour of revelation prints
▪ View the total test's medians.
▪ View the ECG information for a particular event.
▪ Re-examine the case.

4. Single channel ECG

▪ A rock-solid steady ECG base line
▪ Loading processes straightforward.
▪ Mechanism for dominant paper position.
▪ The frequency response ranges from 0.05 to 150Hz.
▪ On a backlit liquid crystal display, the parameters displayed.
▪ Compact, light, portable, and easy to use.
▪ Digital thermal array printer that doesn't need any maintenance.
▪ Operation with a feather bit key.
▪ An inbuilt reversible battery and charger area enclosed.
▪ Both automatic and manual modes area facility.

5. SIMUL-G: PC based ECG machine with simultaneous acquisition

Figure: 1.5 SIMUL-G unit

▪ ECG equipment with DSP technology that runs on a PC.

▪ 0.05 to 150 Hz whole frequency response
▪ Simultaneous Acquisition is a term that refers to the acquisition of two or more items at
the same time.

4
 ▪ Measurement and interpretation of all 12 leads.
▪ ECG to Image Format conversion is possible.
▪ Telemedicine needs to be upgraded.
▪ 12 leads were acquired at the same time.
▪ Display of running traces of 12 leads, divided into 6 groups.
▪ ECG data can be sent to a remote care server for expert opinion.

6. Biphasic Defibrillator

Figure: 1.6 Biphasic Defibrillator

▪ 7" colour display with in-built printer.

▪ Charging time of six seconds on mains.
▪ Offers variable energy choice. (2,3,5,7,10,20,30,50,70,100,150,200 Joules).
▪ Battery capability - seventy - one hundred shocks on single charge.
▪ Both, adult and paediatric paddles support.
▪ Compact and light weight.
▪ Printer 2”

Defibrillation is extensively employed in cardiopulmonary resuscitation (CPR). CPR is an

algorithm-based approach for recovering cardiac and pulmonary function. Defibrillation is only
required for a few varieties of cardiac arrhythmias, such as ventricular fibrillation (VF) and
pulseless. If the heart has completely stopped, as in systole or electrical activity with no pulse,
defibrillation is not recommended (PEA). Defibrillation is not suggested if the patient is
breathing and has a pulse. Whenever electrical shocks are administered erroneously, catastrophic
dysrhythmias such as ventricular fibrillation can develop.

5
1.3 Quality Management System EN ISO 13485 Certification

Nasan received the ISO certificate, as previously stated. It's vital to set up and maintain a robust
quality management system (QMS) for your diagnostic instruments, products, and services to
the success of your company. Your QMS's EN ISO 13485 certification displays your dedication
to working at a worldwide level.

On-site audits are part of the ISO 13485 certification process, and they assess your quality
management system's competence and reliability. Our experts assess both the practical
application and the degree of effectiveness in the areas of design, development, production,
and customer service.
We have comprehensive accreditations and can serve you in regional locations all around the
world as a highly regarded and internationally renowned Notified Body. Our one-stop-shop
portfolio includes a wide range of services tailored to your specific needs.

1.3.1 Benefits of EN ISO 13485 Certification

A production line with an EN ISO 13485 quality management system that is recognized
worldwide, benefits medical devices (including Class I) (QMS). More product opportunities
and broad market access clearance are provided by the certification system. Medical device
manufacturers and subcontractors can use their certified QMS status to make a smooth
transition to specialist certifications like TCP, MDR, IVDR, and MDSAP. Start-up companies
profit from the solid position EN ISO 13485 accreditation provides for future growth and
expansion. Preparing for the audit with attention can also give everyone in the medical device
industry a chance to improve their QMS procedures and workflows.

1.3.2 Risk Management System ISO 14971:2019 Certification

The ISO (International Organization for Standardization) is a huge base of national standards
bodies (ISO member bodies). International Standards are generally manufactured by ISO
technical teams. Each member body with an interest in a topic for which a technical committee
has been established is entitled to a representative on that committee. On the project, ISO works
with both governmental and non-governmental international bodies. ISO works collaboratively
with the International Electro-technical Commission on all aspects of electro-technical
standardization (IEC).
6
ISO/TC 210, International Standard ISO 14971 was created in cooperation between Sub-
committee IEC/SC 62A, Common aspects of electrical equipment used in clinical practice, and
Quality management and corresponding general aspects for medical devices. Using proven risk
management principles, this International Standard was developed expressly for medical
device/system manufacturers. This International Standard could be used as advice for other
firms, such as those in the healthcare industry, in building and maintaining a risk management
system and process. This International Standard addresses procedures for mitigating hazards to
patients, as well as the operator, other people, equipment, and the environment. In general,
activities in which an individual, company, or government is involved can expose them or other
stakeholders to hazards that can result in loss, injury, or harm to whichever they care about.
Because each stakeholder places a distinct value on the probability and severity of harm, risk
system is a challenging topic. The concept of risk is widely considered to have two components:
a) the likelihood of harm occurring; and b) the repercussions of that harm, or how severe it may
be.

1.4 LightWave – A brief introduction

Figure 1.7: LightWave unit

“Lightwave is a 3-channel digital Holter test, connecting doctors in cities to a larger

crowd of patients in remote villages through app… thereby reaching out to the unreached
just like waves of light’’.

Key Features of product.

• Detects 12 types of arrhythmias.
• Heart rate variability (HRV) analysis.
• Doctor gets Holter Device at just Rs.15000 + GST.

7
• Downloading of software is free.
• Doctors pay only for the no. of patients tested (i.e., Rs 500 +GST per test).
• Senior doctor is expected to purchase about 10-15 Holter devices and distribute
to his junior doctors/technicians.

• Period of warranty on Holter device-7 years (no warranty on patient cable).

1.4.1 Benefits
• Junior doctor/technicians in remote locations gets well equipped clinic and senior
doctors gets a larger crowd of patients.
• Patients need not travel to urban areas for treatment, thereby ensuring comfort of
cardiac patients by saving their time, energy and money.
• Service helps available if required.

• Automatic processing: Many times, doctors ask the technician to learn the
software. but if technician leaves, the doctor is in a fix. Through this
service everything will be automatic.

1.4.2 Logistic

• NASAN web application will register the senior and junior doctor/technician’s
details (name, designation, mobile, email, device no).
• Email will be sent to Jr. Doctor’s registered email address. Patient will go to junior
doctor/technician.
• Junior doctor/technician will prepare the patient for the test. Connect the unit to
patient using patient cable and data recording begins.
• After recording is completed then connect the Light wave unit to PC through USB
cable.
• Run Lightwave application. Enter device ID given to the doctor. Click on download
option.
• Patient details dialog box will be displayed. Enter patient details. Click Ok, data will
be downloaded, then data will be uploaded to NASAN server.
• Trained person at NASAN server will do analysis of data i.e., filter the raw data and
generate the final report.

8
 • Senior doctor will receive email /SMS regarding the received report.
• Senior Doctor is having a mobile application—named LightWave.
• Senior Doctor will receive the patient reports for verification on his mobile app
where he can add comments and give his suggestions to junior doctor.
• Senior Doctor can select pages for printout.
• Junior doctor will receive the final email of the report with the comments from senior
doctor.
• Junior doctor/technician will print the report and give it to the patient.

1.4.3 Concept

This is a new service which will help us to reach out to the patients and doctors in the
remote location at a very economical rate.

Add on expenses for a simple test: Let us assume a patient in Baramati has
been asked to take a Holter test. For this, he must travel all the way to Pune if
no doctor in Baramati has Holter (travelling expense) As he is a cardiac patient
he will not travel alone (relative’s expense). It’s a 24-hour test hence he must
spend for hotel (accommodation expense). A simple test becomes very
expensive to the patient. Hence, we have come up with a scheme to increase
patient comfort which will also be cost effective. Patients even in places like
Baramati should have access to facilities like Holter.

9
1.4.4 Why is it beneficial to the doctors?
NASAN will give,
• Software at physician’s end will be given free of cost.
• Period of warranty- 7 years
• Service helps available when required.
• Automatic processing
• We expect senior doctor to purchase 10 machines at a time and distribute it to his
doctor friends or other physicians. Senior doctor will provide Holter to physicians &
all physicians will send him patient data.

Figure 1.8: Flow of the scheme

10
 • Physician or doctor friend will connect the Holter to the patients. After 24 hours, the
physician will download the Holter data and then upload it to Nasan server (this requires
internet connection).

• After receiving it on Nasan server, the biomedical engineer/technician at Nasan

will analyse the uploaded test by removing the artifacts and noisy ECG data and
will send a clean ECG report to the senior doctor’s LightWave application
installed on his/her phone.

• Once the senior doctor receives the report, he/she will assess the report, write
down the comments regarding what has been observed in it and send it to the
junior doctor’s email id.

• Now, the junior doctor can take a print-out of the report at his/her end and give it
to the patient.

1.5 CardiaConnect

This is the new range of Holter service, CardiaConnect that includes 24Hr Analysis
(LightWave) and AF (Atrial Fibrillation) Analysis.

1.5.1 Benefits

• No additional installation cost.

• Additional facility of AF detection to doctors.
• Automatic report generation
• Better diagnosis for patients
• With a click of a button data is transferred.
• Cost effective to doctors, dealers and Nasan.

1.5.2 What does Atrial Fibrillation mean?

When the electrical impulses in your upper two chambers (the atria) fire in a haphazard and
erratic manner when they should be consistent and regular, quivering or twitching occurs
(fibrillation). You may notice a heartbeat or pulse that is sporadic and perhaps quick if this
happens. Some people report that they have a feeling where their hearts are experiencing
palpitations. Atrial fibrillation can be episodic (paroxysmal atrial fibrillation) or persistent
(permanent atrial fibrillation). It isn't life-threatening, but it is dangerous since it can induce
blood clots in the heart, which can provoke a stroke.
11
Obese people need to lose weight, boost their physical activity, and imbibe less alcohol. All these
are healthy lifestyle choices that can diminish the risk of Myocardial infarction and the severity
of the disorder if it gets out of control. To treat AF, medications which further potentially reduce
the heart rate to a near-normal range (known as rate control) or convert the rhythm to normal
sinus rhythm are increasingly utilized (known as rhythm control).

Figure 1.9: Atrial Fibrillation

1.5.3 What causes Atrial Fibrillation?

Although the exact pathophysiology of atrial fibrillation is not always perceived, cardiovascular
distress is the most common cause.

This will be as an outcome of:

• elevated arterial pressure

• heart valve problems
• cardiac defects (congenital)
• pericarditis
• cardiomyopathy
• Coronary artery disease (CAD)
• Diabetes
12
 • having undergone heart surgery
• physical and mental exhaustion
• Sinus infections.

Other health issues that are linked to AF include asthma, lung cancer, and pulmonary embolism.

Many people will get AF despite having no pre-existing illnesses or risk factors. Lone Atrial
fibrillation occurs when there is no identifiable reason.

1.6 Loop Holter – Overview

Since the 1960s, Holter monitoring has been adopted to diagnose suspected irregularities in
adults of all ages. The most familiar surveillance systems allow for seamless recording of three
or more leads for 24–48 hours, however newer Holter monitors allow for two weeks of
continuous ECG recording. The diagnostic yield of Holter monitoring will be accelerated via
extending the ECG registration period, especially for infrequent but enduring rhythm
abnormalities. Loop Holters, which can monitor patients for up to 7 days by capturing the ECG
taken a few minutes before and after the commencement of an irregular ECG in memory and
exchanging data to the cardiac unit, have matched this urge for significantly longer ECG
monitoring.

Loop recorders are event recorders with a 'loop' feature that constantly examine the
Electrocardiogram and understand concepts about major cardiovascular events that are detected
programmatically using specified algorithms and ECG registration a few minutes just before
the abnormality begins. Because loop recorders could be used by people to demonstrate a link
between clinical signs and an abnormality, they can also be used to rule out a pathogenic role for
heart rate perturbations in detecting hypotension or restlessness if no arrhythmia is present. The
ability to measure the immense scale of an abnormality and the identification of rhythm
disruptions beyond that confine of an automated system or cognition are two significant
advantages of a continuous Holter monitoring system.

Assessing irregular heartbeat episodes should help clinicians improve treatment choices,
especially in irregularities which arise naturally and cause distressing

13
consequences. Portable Holter trackers do have disadvantages, including a short monitoring
period, the difficulty to communicate actual information to that same accompanying
cardiovascular system, and the need for constant cooperation in between the individual and
medical personnel.

Many gadgets exist that allow individuals with suspected or known arrhythmias to monitor their
cardiac rhythm and rate. Figure 1.10 shows a table describing different cardiac monitoring
devices.

Figure 1.10: Main characteristics of Different Cardiac Monitoring devices

14
1.6.1 Basic Principle of Loop Recorder

A loop recorder is a type of cardiac monitor that is worn beneath the skin of the chest. It has a
wide range of applications. Detecting the cause of fainting, palpitations, abnormally fast or
extremely slow heartbeats, and hidden rhythms that could cause strokes are among the most
common.

During a minor operation, your heart healthcare provider will implant a loop recorder
(cardiologist). The little gadget will be implanted beneath your skin on the chest wall, just above
your heart. The device functions similarly to an electrocardiogram (ECG), continuously
collecting electrical impulses from the heart. This can assist in the detection of irregular heart
rhythms, which can lead to a variety of issues, including fainting.

A certain bundle of cells initiates the input impulses that starts the cardiac beating in normal
circumstances. These cells are found in the heart's sinoatrial (SA) node. This node is found in
the right atrium, the right upper compartment of your heart. This signal travels quickly through
your cardiac conducting unit to the ventricles. The lower ventricles, or chambers of the heart, are
located here. As the impulse traverses, it causes adjacent regions of your heart to squeeze.

The cardiac circulation is highly vascularized as a result of this. Heart rhythm issues may occur
if this signalling system is disrupted. Syncope and arrhythmia are two issues that could arise as
a result of this. An irregular cardiac rhythm may prevent your heart from pumping enough blood
(arrhythmia). Your brain's blood supply is limited, causing you to pass out. You normally recover
completely once the rhythm returns to normal.

1.6.2 Why is the Loop Holter needed?

If you have a cardiac medical problem which leads to difficulty for an irregular rhythm, your
doctor can prescribe a Holter tracker to assess for prescription modifications,
cardiac restlessness or heart murmur, and daily concerns such as vertigo, disorientation, and
breathlessness. Your doctor may advise you to use a Holter tracker for a day or two even if you
haven't seen any indication of an unstable angina.

If you have physical signs of the cardiac issue, such as an irregular heart rhythm (arrhythmia) or
unusual collapse, the physician will prescribe an electrocardiogram (ECG) immediately.

15
An ECG is a non-invasive test that checks the rhythm of your heart using electrodes strapped to
your chest. However, as you are only connected to the device for a brief period, an
electrocardiogram (ECG) may miss any anomalies in your cardiac rhythm. If your symptoms
imply that an abnormal heart rhythm is the source of your problem, the physician might advise
the patient to wear a Holter tracker for 2 days or up to a week or two.

The following heart rhythms can be recorded:

• Atrial fibrillation is also known as atrial flutter.

• Atrial tachycardia with many foci
• Supra-ventricular tachycardia paroxysmal
• Heart rate is low (bradycardia)
• (3 beats) ventricular tachycardia
• long-term or short-term
• Tachycardia in the sinuses
• Pauses
• Ectopy or junction rhythms
• atrio-ventricular block
• Entire cardiac breakdown
• Tachycardia/supra-ventricular ectopy
• Different tachycardia
• Ventricular ectopy

1.6.3 Pros and Cons of Loop Recorder

A loop recorder can catch information that might otherwise be overlooked by an ECG or Holter
monitor, especially if it is unusual. For example, if you are experiencing vertigo, your
cardiologist would determine whether your symptoms are caused by a cardiac problem or not. A
conventional ECG merely monitors the cardiac activity for a certain time. If you faint again, an
embedded event tracker keeps track of your cardiac activity for a brief period, improving the
chances of detecting any aberrant cardiac rhythm. Your cardiologist could use the data from your
embedded event tracker so as to confirm your diagnosis and formulate a treatment plan. If you
have a high risk of stroke, your doctor might suggest an embedded event tracker. Irregular beats
that trigger abnormal heart rhythms, raise the danger of attack.

16
The most significant disadvantage of loop recorders is their high initial price. Some people may
be a little uneasy about implanted recorders because they require a surgical procedure to connect
the recorder.

1.6.4 Risks

Wearing a Holter monitor does not pose any substantial dangers. The sensors (electrodes) may
cause slight discomfort or skin irritation to some people.

Other electrical equipment’s normally have little effect on Holter monitors. However, some
gadgets may cause the signal from the electrodes to the Holter monitor to be interrupted. If you
have a Holter monitor, stay away from the following things:

• Blankets with electricity

• Toothbrushes and electric razors
• Magnets
• Detectors of metal
• Ovens with microwaves

For the same reason, keep cell phones and portable music players at least 6 inches away from
the Holter monitor.

1.7 ECP – External Counter pulsation – Overview

Cardiovascular disease has emerged as one of our country's significant health concerns. The
societal burden it imposes is growing at an alarming rate. The treatment of cardiovascular illness
has gone from simple medicinal therapy to complex surgery and from an easy electrocardiogram
to an advanced computer tomography (CT) scan. However, the incidence of cardiovascular
disease has not decreased despite these advances in therapy and detection. Growing health
systems are reducing people's and families' assets in remote, moderately remote, especially urban
sectors.

FDA-approved painless treatment ECP, is commonly preferred for CHD sufferers. CABG
(coronary artery bypass grafting), PTCA (percutaneous transluminal coronary angioplasty),
Gene therapy, and other methods are used to treat heart abnormalities. However, ECP is the sole
non-invasive treatment option. Because the stain utilised may not be compatible with the human
body, re-blockading of coronary arteries may occur following effective PTCA treatment. Angina
17
symptoms usually improve after CABG; however, some individuals experience significant
consequences. The most serious side effect of CABG is operational death. Patients who have
poor stroke volume, have had a current cardiac arrest, had cardiac problems, and have diabetes
or hypertension are more likely to die during surgery. As a result, it's critical to give
consideration to this potentially fatal disease. The ECP procedure is used to enhance aortic blood
flow. During diastole, the aortic diastolic pressure, coronary blood flow, and central venous
return are all raised while three sets of inflatable cuffs contract sequentially. ECP decreases nitro-
glycerine use and improves angina symptoms and exercise tolerance. The mechanism of action
of EECP treatment is to change flow velocity across the vascular system. ECP causes increased
shear stress in the coronary circulation, which causes a cascade of growth factors to be produced,
resulting in the development of new blood vessels in the heart (arteriogenesis and angiogenesis).
We can obtain information on ventricular contraction and relaxation (systolic and diastolic
phases, respectively) from an ECG. These two will assist us in triggering leg cuff pressure. The
cuff will deflate before systole begins, lowering vascular resistance.

Figure 1.11: ECP Setup

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1.7.1 Basic Principle of ECP

Mechanical assembly is required for ECP, which comprises three sets of pneumatic sleeves
placed on the lower leg. The calves, lower knee, and upper knee are all bound with these cuffs.
On the therapy bed, the patient lies down. The patient's ECG cable and plethysmography are
connected, and parameters are continuously monitored. The cuffs' inflation and deflation are
timed to each heartbeat. Cuffs are inflated and deflated in a specific order to ensure that blood
flows from the lower to the upper body. The blood in the leg surged up into the upper body,
creating collateral routes for the blood vessels. It may operate as a natural bypass, allowing more
blood to flow to the heart and alleviating angina symptoms. Calf cuffs are the first to inflate,
followed by lower thigh cuffs, and finally upper thighs. At a single time, three cuffs are deflated
simultaneously. The compression of the cuffs will be able to shift a significant volume of both
arterial and venous blood from the lower extremities to the upper region of the body due to the
increased surface area covered by the cuffs and bladder. Depending on the patient's needs and
capacity, the external cuff pressure can gradually increase from 80 mmHg to 300 mmHg. Left
ventricular preload, ventricular contraction, and arterial compliance will all be affected by ECP.
The more the myocardial muscle stretches, the more it contracts, resulting in an increase in stroke
volume.

1.7.2 Importance of ECP

Angina could be a fleeting discomfort or pain that happens once some of your muscle is unable
to receive enough blood and chemical element to satisfy its needs. The coronary arteries within
the heart offer chemical element and blood to the centre muscle. Reduced blood flow suggests
that the centre muscle receives less chemical element than it needs to operate properly if these
arteries slim. Coronary artery disease, a disorder marked by the formation of fatty plaques within
the blood vessel walls, could be a common explanation for constricted coronary arteries. ECP
has 2 major goals: to scale back left cavum burden and to boost arterial pressure. ECP could be
a technique for increasing coronary blood flow by retrograding arterial blood vessel blood flow.
The circulation is littered with EECP. Acute hemodynamic effects embody multiplied arterial
blood vessel blood flow, multiplied coronary blood flow, and progressive will increase viscous
input. It’ll relax the blood inner muscle and open the antecedent dormant collaterals within the
short term. By rectifying epithelial tissue operates, it'll have a long impact on laminar blood flow.

19
 Figure 1.12: Blood flow in the coronary artery

1.7.3 Who should not be considered for ECP therapy?

• Aortic insufficiency
• Heart rhythm irregularities
• Extreme hypertension (increase in BP)
• Peripheral artery disease (PAD) that affects the legs
• A genetic heart ailment is a cardiovascular defect that occurs at infancy.
• Cardiomyopathy with hypertrophy
• Heart enlargement
• A person having artificial heart
• Atherosclerosis of both the lungs

1.7.4 Application of ECP other than Angina

• Cerebrovascular illnesses triggered by ischemia

• Disorders of the central nervous system
• Sleep deprivation
• Diabetes
• Sudden loss of hearing
• Renal disorder

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1.7.5 Effects of ECP other than cardiovascular disease

1.7.5.1 Brain Ischemia (Cerebrovascular disease)

Ischemia of the brain happens once to meet metabolic demands, flow of the blood to the central
nervous system is insufficient, ending up in an absence of element or cerebral drive that causes
brain tissue death, called ischemic stroke. Beside subarachnoid haemorrhage and neural structure
haemorrhage, it's a form of stroke. Ischemia causes changes in brain metabolism, a drop by
metabolic rates, vision, body movement, and speech issues, measure the foremost common signs
of brain ischemia. Brain ischemia is caused by something from red blood cell anaemia to inborn
viscous abnormalities. State of mind, blindness, coordination problems, and physical weakness
measure all symptoms of brain ischemia. Stroke, viscous, and different complications might
occur as a result of cerebral ischemia.

Ischemia of the brain has been linked to a number of disorders and abnormalities. In compared
to their healthy counterparts, Brain ischemia is more prevalent in people who have sickle cell
trait, clogged blood capillaries, irregular heartbeats, cholesterol build-up in the arteries,
thrombosis, significantly lower blood bp as either a response of a cardiac arrest, and hereditary
heart trouble. Ventricular fibrillation is an unusual heartbeat pattern that can force your
cardiovascular system to stop fully beating, cutting off oxygen delivery. Furthermore, irregular
heartbeats can lead to the production of blood clots, depriving all organs of oxygen.

A cardiac arrest can cause cerebral ischemia due to a combination of heart attack and low arterial
pressure. Extremely low arterial pressure usually indicates that tissues are not getting enough
oxygen. Untreated heart attacks can cause blood to clot and prevent blood from reaching the
brain or other vital organs. Medication overdose and drug responses can also cause arterial
pressure to drop exceedingly low. Therefore, as a consequence, incidents other than cardiac
attacks can cause brain ischemia.

1.7.5.2 Effect of ECP on cerebrovascular disease

The ECP regulates cerebral blood flow. It produces collateral circulation to the ischemic tissue
due to blood flow control. ECP causes an increase in blood flow by raising blood pressure. From
the contra-lateral sides, ECP enhances brain perfusion and collateral supply. Increased nitric
oxide production improves collateral arteriogenesis and coronary flow reserve.

21
1.7.5.3 Diabetes Neuropathy

Diabetic peripheral neuropathy is indeed a type of nerve impairment caused by diabetes mellitus.
Nerve fibres all over the system will be impacted by hyperglycaemia. The nerve fibres that pass
throughout your lower extremities of your body will normally be plagued by diabetic
neuropathy. Uncontrolled blood glucose puts you in danger for all of the complications that
associate with polygenic disease, as well as nerve injury. The constriction of blood vessels is
that the 1st infective alteration in little blood vessels. Somatic cell dysfunction is directly
connected to the event of vessel abnormalities, like decreased strain is induced by glomerular
capillary barrier expansion and capillary proliferation. Tiny blood vessels malfunction begins
early in life in diabetes, parallels cerebral deterioration, and may be large enough to sustain the
intensity of anatomical, physiological, and symptomatic abnormalities shown in
hyperglycaemia.

1.7.5.4 Fundus Diabeticus

In diabetics, fundus diabeticus is an optical infection that can cause macular degeneration and
blindness. This disrupts all blood vessels in the eyes. Blood vessels in diabetic retinopathy
patients may enlarge and leak fluid. In certain patients, aberrant new blood vessels form on the
retina's surface. Increased blood sugar causes blood vessels to enlarge.

1.7.5.5 Effects of ECP on diabetes and its adverse diseases

Vascular damage, including micro-vascular and macro-vascular, is a long-term consequence of
diabetes. This harm is caused by chronically high blood glucose levels. Uncontrolled diabetes
impairs the synthesis of nitric oxide by the vascular endothelium, which is the lining and
covering of the inner part of vessels. Nitric oxide is a powerful natural vessel wall defender
against stress, inflammation, and thrombus (clot) formation, as well as aiding the vessel's
flexibility and dilatory properties. This nitric oxide level has increased by 60% after ECP
treatment. This enhanced nitric oxide level will protect diabetic individuals from micro and
macro vascular complications. Insulin's ability to regulate glucose uptake by skeletal muscle,
cardiac muscle, brain, and adipose tissue is another major method of blood glucose management
by the body. GLUT 4, a transport transporter protein, is responsible for this use. Our skeletal
muscles are the principal users of glucose. According to one study, a course of ECP treatment
boosted skeletal muscle GLUT-4 protein by 47%. This increase in nitric oxide and GLUT-4
protein now plays a crucial role in glucose absorption and insulin effect enhancement. The
insulin sensitivity index (ISI) increased by 21% overall. It means that after ECP treatment,
patients simply need a lower dose of insulin to lower blood glucose levels. ECP would increase

22
muscle perfusion, increase intramuscular eNOS and NO expression, increase GLUT-4 protein,
and chronically improve glycaemia control in patients.

1.7.5.6 Ischemic Eye disease

Ischemia is a condition in which blood flow towards cells becomes restricted, resulting in a lack
of oxygenation essential for cell function. Anaemia is a condition in which blood capillaries get
clogged, leading to tissue injury or malfunction. Ocular ischemia syndrome is a set of ocular
signs and symptoms caused by severe, long-term arterial hypo-perfusion of the eye. Reduced
blood supply to the eye causes this type of acute visual loss. Because oxygen is transported to
tissues by the blood, tissue starvation occurs when the blood supply is insufficient. Blood does
not flow adequately to your eyes optic nerve in the highly metabolically active tissues of the
heart and brain, eventually causing permanent damage to this nerve. The optic nerve connects
your eyes to your brain, carrying signals. These messages are subsequently translated into the
visuals you see by your brain. The optic nerve does not receive enough oxygen or nutrients when
blood flow to it is decreased or stopped. The optic nerve eventually stops operating correctly and
dies. This ocular anomaly is related to function of the Arteria Carotis. The Arteria Carotis are
the primary blood vessels that supply oxygen and nutrients to the brain. are found in the neck.
Plaque begins to build up in the arteries as people age. If the carotid arteries are compromised,
stenosis, or narrowing of the arteries, can occur. This can restrict blood flow and lead to the
formation of tiny clots that break off.

1.7.5.7 Effects of ECP on Ischemic Eye disease

Ischemia is caused by a lack of blood supply and oxygen, and the major goal of ECP is to enhance
blood and oxygen flow to the organs, which will be cured by ECP treatment. There is no clinical
evidence to support the benefits of ischemia caused by ECP.

Other illnesses, such as sudden hearing loss and erectile dysfunction, can be efficiently treated
with ECP treatment.

1.7.6 Benefits of ECP therapy

• Increased energy and tolerance to exercise
• Help reduce chest discomfort symptoms.
• Lankiness of breathing signs should indeed be lessened.
• Reduce tiredness and palpitations in the heart
• Lessen the pain in the limbs induced by peripheral vascular disease.
• Coronary heart disease symptoms usually alleviated for long term.
23
 • Coronary Perfusion has improved significantly.
• Male sexual function keeps strengthening.
• Reduce the symptoms of Parkinson's disease
• Reduces the signs of dementia.
• Lower heart strain & reduces arterial stiffness.
• Epithelial functioning is enhanced by backward artery circulation
• Impact of Peripheral Exercise
• Restructuring of the Cardiovascular system
• Collateralization is recommended.
• Oxygen consumption has improved
• Atherosclerosis regressing.
• Ventricular function develops.
• Cardiac Output Increase
• Reduced Cardiac Workload
• Growth factors are released.
• Symptoms of coronary and heart problems are minimized, and categories are altered.
• Limit your medication intake (including Nitro-glycerine & Ranolazine)

1.7.7 Possible benefits of ECP

Anti-angina medication may be reduced as a result of the ECP programme. Improved energy
levels may result after treatment. Therapy may improve one's quality of life. The protocol may
enhance endurance. The procedure may result in increased strength. Sessions may boost your
mood. Memory may improve as a result of the machine. Sexual functioning may improve as a
result of treatment. Therapy may improve one's sense of well-being. Sessions may improve your
capacity to perform routine tasks.

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1.8 Regulatory Affairs – Overview

Regulatory affairs professionals advise product innovators on proper regulatory tactics to ensure
the product can be lawfully marketed while they work to bring their concept to life. Regulatory
affairs must advise the product department on the effects of particular choices on the manner of
regulatory filing necessary, as well as associated timescales, from the very first meetings.

Regulatory affairs must cooperate with regional teams for items that will be supplied abroad to
ensure that the product has a global regulatory plan. To be effective in this function, the
regulatory affairs expert must be familiar with the foreign regulatory requirements that the device
will face and ensure that the product development team takes these requirements into account
when testing and validating the device.

1.8.1 What are Regulatory Affairs?

A regulatory affair as a field encompasses a wide range of skills and jobs. It is composed of a
group of people who act as a link between the seemingly contradictory realms of legislation,
market, and buyers in order to ensure that advertised goods remain safe and efficacious when
used according to instructions. Professionals in regulatory affairs arbitrate relationships amongst
regulators (the administration), monitored (industry), and consumer (clients) in order to obtain
quality goods to consumers and keep those somewhere while limiting the sale of bad products.

Among the products covered are groceries and farm commodities, pet food, medical instruments,
in vitro and in vivo diagnostic devices and examinations, and medications. Only a few of the
areas covered include production and analytical testing, preliminary security and performance
testing, clinical testing, and post-marketing follow-up. With advertising concerns, information
management, documentation, project planning, financing, subject settlement, and dispute
resolution have all been brought into play.

A complicated system of checks and balances has evolved quite a bit to develop a strategy for
quickly and effectively governing advertising. Regulatory affairs specialists in the industry work
with medical researchers, physicians, manufacturers, and sales and marketing departments to say
that the state has all of the data it needs to evaluate a product. Regulatory affairs professionals
help the government understand and enforce laws in order to protect the public. To comply with
the congressional obligation, the Food and Medicine Administration (FDA) must acquire and
include all facts considered fit to assess pharmaceuticals, biosimilar, or equipment for clinical
utility.
25
The agency uses this information to determine whether or not the commodity should be readily
available, and if so, how should it be advertised and sold?

On the consumer side, their personnel assist in keeping the other two groups honest, as well as
providing the impetus for Congress to pass rules governing how the government and industry
treat products.

1.8.2 Job of Regulatory Affairs department

The regulatory affairs (RA) department of a pharma industry is in responsibility of obtaining

clearance for biopharmaceutical process to ensure that authorization is retained for just as long
as the firm seeks the product being on the sale. This serves as a liaison between both the
regulatory authority and the project management team, and also a transmission medium with the
statutory powers as the work progresses forward, with the goal of project achievement plan
accurately envisions the governmental council's requirements even before drug is ready. New
legislation, rules, and compliance procedures must be kept up to date by RA. Regulatory bodies
expect enterprises to decide how to implement such guidelines and norms, and they commonly
allow for some discretion. The RA department is crucial in guiding the development team on
how to understand the standards in the most effective way. During the development phase, good
working connections with authorities are essential, for example, to discuss issues such as
divergence from regulations, the biomedical research agenda, and composition improvement.

1.8.3 Marketing Applications

When a product's design is complete and a company is ready to sell it, regulatory affairs helps
the product development team create a successful marketing submission. The most prevalent
type of submission in the United States is a premarket notice, commonly known as a "510(k)",
which gives FDA legal authority to regulate medical devices.

Regulatory affairs must identify a predicate, which is a similar product that has already been
legally marketed, in order to complete a successful 510(k). The new device must then be shown
to be substantially equivalent to the predicate device in the submission. Regulatory affairs must
file a premarket approval application, or PMA, if no predicate is available, to show that the
device is safe and reliable for the objective with which it was created.

Regulatory affairs are also in charge of assessing all products labelling to ensure that all claims
are in line with the product's approved intended use. For device sales teams, marketing claims
are critical in differentiating their product from that of a competition. As a result, medical device

26
businesses rely on their regulatory affairs departments to guarantee that all device-related
documents are appropriate.

1.8.4 Post Market Surveillance

After a device is cleared or approved, medical device businesses rely on their regulatory affairs
staff. The regulatory function is involved in device surveillance in the post-market setting,
guaranteeing that any serious side effects or defects are reported to the FDA in a reasonable
timeframe.

Firms can use post-market surveillance reports to spot trends in complaint data and as a warning
mechanism when a gadget has an undesired effect. If a firm receives many adverse event reports
showing that an implanted device is causing unexpected discomfort weeks after surgery, it's
conceivable that the device is the source of the pain. To avoid unforeseen consequences,
regulatory personnel evaluate post-market surveillance reports and collaborate with the FDA to
issue voluntary recalls.

1.8.5 Medical Devices and International Regulatory Affairs

While negotiations with the Food and drug administration are critical in the United States,
regulatory affairs should also plan to collaborate with health agencies and lawmakers within
every nation where their firm wants to launch their device. In some countries with less
established medical device regulation, commercial permission or certification from the Food and
drug administration can be counted on to secure clearance or approval.

Many nations have their own medical equipment standards; thus, it is vital to comprehend the
variations in global regulatory tasks to ensure that innovative products can be commercialised.
Effective regulation of health players stay up with international innovations and current
legislation and activities because the legal governance landscape is continuously evolving.

27
 Section 2: Methodology

2.1 LightWave Holter Installation/Initialization

• Initially make sure that LightWave unit is switch off.

• Use 2 AA size Duracell for LightWave. Insert batteries in batteries compartment as per
polarity indicated and put the battery cover.
• Prepare the patient and connect patient cable to patient as shown in ‘Fig 2.4 Electrodes
placement’.
• Select Recording (REC) mode by using the slide switch.
• The green (Recording status) LED on front will glow. Buzzer will give sound.
• Press “Start key”. Buzzer will become off. Memory Full (Red) LED will glow, and
previously stored data will start erasing. At that time Green LED will remain glow.
• After about 5 to10 sec, buzzer will give beep sound and recording will start. This will be
indicated by blinking of Recording status (Green) LED and Memory Full (Red) LED will
become off.
• After 24 hrs of recording, Buzzer will give two beeps. Recording status (Green) LED
will stop blinking. Memory Full (Red) LED will glow continuously indicating recording
is over.
• Keep the slide switch at OFF position when data recording is complete.
• When any one of the lead from patient body get displaced the LEADS OFF LED will
glow with buzzer sound, check lead cable for any loose connection and press Event Mark
key on the unit.

2.1.1 Steps for downloading data

• Remove batteries from the unit.
• Connect download cable to PC and Holter unit.
• Select USB mode by using the slide switch.
• Recording status (Green) LED will glow continuously.
• Run LightWave software.
• Select download option.
• Do not execute other program during downloading the data.
• If download error occurs, following dialog box will display.

28
 Figure 2.1: Error while downloading Holter data

• Enter patient details and press OK.

• After about 2 sec, “LightWave unit found” message will be displayed. Press OK.
• Recording status (Green LED) will start blinking, indicating data is getting download.
• After about 5 to 7 minutes data download will get complete if low speed option is
selected.
• “Data has been downloaded successfully” message will appear on PC screen. Buzzer will
sound two beeps. Recording status (Green) LED will stop blinking, it will become off.
Memory Full (Red) LED will glow continuously indicating data download is over.

REC (ON/OFF) Switch

USB cable
connector

Patient Cable

Figure 2.2: LightWave Unit

29
 Figure 2.3: Patient Cable

2.1.2 Patient Preparation

• Proper patient preparation is the most important factor in obtaining proper results from a
system. If electrodes are applied to improperly prepared skin site then this may result in
excessive base line shift and severe artefact while obtaining an ECG.
• Apply some jelly to the electrode site and thoroughly rub the site with gauze till it
becomes slightly red. This removes the horny non-conducting layer of the epidermis
enabling a good electric contact with the body fluids.
• Remove all the traces of jelly by wiping the abraded site with warm dry cloth and
completely dry up the site with dry towel. The skin must be clean, dry and completely
free of jelly for the electrodes to remain well in position till the end of ECG acquisition.
• Take an electrode and peel it off from its plastic backing. Finger contact with the adhesive
should be minimized and jell in the foam pad should not be disturbed. If the jell has dried
out then discard the electrode.
• Apply the electrode to the prepared site and run your fingers around the foam pad
smoothing it from the centre out. Repeat this procedure for all sites.

30
2.1.3 Electrode Placement

Figure 2.4: Electrode Placement

• One by one, insert the electrodes on the intended site. Cover the entire electrode area by
pushing the electrodes from inside to outside. Make sure the gelled patch is securely in
touch with the skin. Place the patient's lead on each electrode according to the colour
code.

• Tape the electrode with medical sticky tape.

• Form a loop in the patient cable and secure it with Medical Adhesive Tape.(dressing
tape/ Bandage tape) to avoid stress on electrodes during usage.

31
2.1.4 Basic Working of the LightWave Holter
• Step 1: The doctor will be provided with a LightWave registration google form
for registering his/her Holter device with the company for conducting the tests.
After successful registration, he can start taking tests efficiently. This is how the
registration page looks like.

Figure 2.5: LightWave registration form

After successful registration, the doctor gets an email confirmation for performing his
tests, along with the device ID number once he/she submits the google form.

He/she will conduct his tests using this device number only.

• Step 2: After opening the software, click on ‘Configure’ in the menu bar and
configure the hospital details by entering the hospital name, hospital address,
junior doctor’s name entered while registering for device number and designation etc.

32
Also, check for the Holter’s device number provided to the doctor via email.

Figure 2.6: LightWave software interface

Figure 2.7: Configure window

33
• Step 3: Check that internet connectivity is available to PC where LightWave
software is installed and check its connectivity. Now enter the given device number
(received on your registered email ID) to you. Then press Apply and click ok. Now,
exit from LightWave software.

Figure 2.8: Enter the device number

• Step 4: Connect the unit to the PC and slide its switch to USB mode for data
transfer. For this, click on the ‘Download’ button.

Figure 2.9: Download button

• Step 5: After clicking on the download button, this screen appears. Now, enter the
fields like Patient ID, Patient name, height, weight, etc. Once entered, click on OK.
Note: Patient name and Age is a mandatory field.

34
 Figure 2.10: Patient details window

• Step 6: After clicking on OK, the recorded data starts getting downloaded in the
software for further analysis. It may take few minutes for this process.

Figure 2.11: Downloading the recorded data from the unit

• Step 7: It shows this message which indicates that the data has been successfully
downloaded and now; you can upload your data on the NASAN server.

Figure 2.12: Data downloaded successfully

35
• Step 8: The upload process begins, and the data successfully gets uploaded on the
NASAN server.

Figure 2.13: Data uploaded successfully to the server

• Uploaded test is analysed on LightWave analysis server and reports are

generated.

• Step 9: To view the report on senior doctor’s mobile.

o Click on “LIGHTWAVE” app from mobile home screen. You will be directed to
this screen.
o Enter email Id (Senior doctor) for e.g.: abc@gmail.com and click on
“REGISTER”.

Figure 2.14: App interface

36
• Step 10: You will be directed to this page.

Figure 2.15: List of reports

• Step 11: Wait for few seconds and all report names will be visible. Click on one
name e.g.: Mr. normal ecg and press “VIEW REPORT”. Swipe left/right to see all
pages of reports & then press back key to exit. Click in comments box as shown
below and enter comments.

37
 Figure 2.16: Report

• Step 12: Similarly, by clicking the next icon you can view all report pages one by
one. You can zoom the page by clicking on the magnifying glass icon. You can
even add pages to print by ticking the “Add to Print” box or simply exit.

Figure 2.17: Navigating through the report

38
 Figure 2.18: Adding pages to print and writing comments

• Step 13: Now, report will be sent to Jr. doctor mail ID. He can take printout of report
and hand over the report to the patient
.
2.2 Basic Working of the CardiaConnect unit
• Step 1: Open the “CardiaConnect” software. Click on Configure on the task bar.

Figure 2.19: Configure window

39
• Step 2: Enter the Hospital Details. Enter the junior doctor’s name entered while
registering for device number and designation etc., from where the data is uploaded.
Press the add button.

Figure 2.20: Hospital details

• Step 3: Check that internet connectivity is available to PC where CardiaConnect
software is installed and check its connectivity. Now enter the given device number
(received on your registered mail ID) to you. Then press Apply and click ok. Now exit
from CardiaConnect software.

Figure 2.21: Enter device number

40
• Step 4: Record the data in Holter unit. Connect the Holter unit to PC through USB
cable. Move the switch on Holter at USB side. Double click on software icon. Check
that software opens. Now click on the given download button. Now, enter the Patient
details.

Figure 2.22: Patient details

• Step 5: Click OK and wait till the data gets downloaded.

Figure 2.23: Data downloaded successfully

• Step 6: Now, it asks whether you want to upload your data on the 24Hr analysis server
(LightWave), AF Analysis server, or both 24Hr and AF Analysis server
(CardiaConnect). We will click on the 3rd option, ‘24Hr and AF Analysis’ and see to
which server does the test gets uploaded.

41
 Figure 2.24: Server options
• Step 7: The upload process begins, and the data successfully gets uploaded on the
NASAN and AF server, respectively.

Figure 2.25: Data uploaded successfully on server

• This is how the CardiaConnect software works when data is uploaded on 24Hr and AF
Analysis option.

2.2.1 Steps to follow when 24Hr Analysis option is selected

• 24Hr Analysis is where a senior doctor will provide Holter units to other junior doctors.
• The Jr. Doctor will connect the Holter to the patient and monitor him/her for 24 hours
(record his/her data), download it after 24 hours and send it on the Nasan server.

42
 • Once the data has been successfully uploaded on the Nasan server, the senior doctor
will have the LightWave application installed in his phone where he can view the reports
directly and write his suggestions and send it back to the physician.
• The Jr. Doctor can take prints of the report at his/her end and hand over the report to the
patient.
• Once you click on the 24Hr Analysis option, the upload process begins, and the data
successfully gets uploaded on the NASAN server. You will get this message once data
gets uploaded.

Figure 2.26: 24Hr Analysis data upload

• The further process is exactly like what it is mentioned in the LightWave Holter
working.

2.2.2 Steps to follow when AF Analysis option is selected

• AF Analysis is where the cardiologist will get the 24-hour data from the Holter as he
downloads it on the software.
• With just one click, the data gets uploaded on the NASAN server.
• NASAN server further sends the data to the AF server.
• Based on the data, a report is generated and is sent to the respective doctor via
NASAN server.
• Once you click on the AF Analysis option, the upload process begins, and the data
successfully gets uploaded on the AF server.

43
 • A German company has developed an unchallenged algorithm for AF detection. This
algorithm will detect and generate an AF report based on our data.

Figure 2.27: AF Analysis data upload

2.3 Current Status of Loop Holter

The Loop Holter will conduct the ECG test for 7 days with flexible heart rhythm analysis
for the cardiac patient. The report will offer full-disclosure of the ECG for verification of
the analysis. It will record, diagnose, analyze and transmit ECG data in a reliable and
seamless manner. As of now, the development team is working on the firmware and
prototype of the Holter. The testing of the Loop Holter PCB will shortly commence in the
month of June and trials will be conducted further. Due to the company’s rights and orders
given by the mentor, I cannot disclose the information and work done up till now till the
product is launched in the market.

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 Section 3: Results, Discussion and Conclusion

The work on the LightWave scheme had started from July 2021. The device functions properly
and is of great significance for cardiac patients. Testing procedure of the physical unit ended
long ago but we are still trying to improve on certain suggestions and feedbacks given to us
by the dealers and customers. Due to IP protection and orders given by my mentor and the
company, I cannot fully disclose the designs of the product in the result and discussion section.

Both the Holters i.e., LightWave and CardiaConnect are in the functional stage right now but
to improve its usage and convenience, we are working on developing a new analysis software
for the doctors where they can immediately have access to the tests uploaded by them on their
server, analyze it themselves, so that they do not face any issue while delivering the report to
the patient. This took 1-2 months to be done. The software is almost ready and we are testing
it with different patient tests on the day-to-day basis to observe its scalability and output
delivery.

Figure 3.1 and 3.2 shows a few pages of how the LightWave report looks like.

Figure 3.1: Maximum HR page Figure 3.2: Minimum HR page

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The images above are of a 55-year-old female patient having Premature Ventricular
Contractions i.e., PVCs. Extra heartbeats called premature ventricular contractions (PVCs)
start in one of the heart's two lower pumping chambers (ventricles). These extra beats throw
off the typical heart rhythm, giving a fluttering or skipped beat sensation in the chest.

Figure 3.3 shows the report of a 32-year-old female patient’s ECG diagnosed with arrhythmias
like Bigeminy, VTach and VE Pair. The software, based on its algorithm filters out noisy ECG
data, diagnoses the correct angina episodes and helps deliver a clean ECG report with
appropriate analysis to the patient.

Figure 3.3: Arrhythmia Disclosure report

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3.1 Overall Understanding
• One of the important things learnt is how the quality of a product is maintained
by meeting the customer and regulatory requirements with continuous
improvement.
• Different Certifications required for medical devices- Market Study.
• Understood in detail the working of different medical devices like defibrillator,
patient monitor and ECG machines like Aasan, TeleCardia, SIMUL-G and
mainly, the digital Holter.
• Understanding of the basic concepts of software testing and the handling of Remote
Desktop Protocol (RDP).
• Overall understanding of the software and hardware Device. Prove scalability and
performance of software. Further the software has been developed to address the
need of reducing the manual paperwork of different insurance forms.

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 Section 4: Ref. and bibliography

1. Diabetic Neuropathy Christopher Gibbons, MD, MMSc Peter J. Dyck, MD John D.

Stewart, MBBS, MRCP(UK), FRCP P. James B. Dyck, MD
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Sharma, MD, FACP,* Heidi K. Ramsey, BS, RCEP,† and Tahir Tak, MD, PhD, FACC,
Clin Med Res. 2013 Dec; 11(4): 226–232.
3. Enhanced external counterpulsation for ischemic heart disease: what's behind the
curtain?, Piero O Bonetti, David R Holmes Jr, Amir Lerman, Gregory W Barsness,
J Am Coll Cardiol. 2003 Jun 4;41(11):1918-25. doi: 10.1016/s0735-1097(03)00428
4. The multicenter study of enhanced external counterpulsation (MUST-EECP): effect of
EECP on exercise-induced myocardial ischemia and anginal episodes, Rohit R
Arora, Tony M Chou, Diwakar Jain, Bruce Fleishman, Lawrence Crawford, Thomas
McKiernan, and Richard W NestoJ Am CollCardiol. 1999 Jun, 33 (7) 1833–1840
5. Enhanced external counterpulsation improves endothelial function and exercise
capacity in patients with ischaemic left ventricular dysfunction,Darren T Beck 1, Jeffrey
S Martin, Darren P Casey, Joseph C Avery, Paloma D Sardina, Randy W Braith,
Clin Exp Pharmacol Physiol. 2014 Sep;41(9):628-36. doi: 10.1111/1440-1681.12263.
6. Enhanced External Counterpulsation (EECP): An Evidence-Based Analysis, Ont Health
Technol Assess Ser. 2006;6(5):1-70. Epub 2006 Mar 1.
7. Enhanced External Counterpulsation Waveform Interpretation and Clinical Application
: A Primer and Case-Based Troubleshooting Guide, Dr. S. Ramasamy
8. Evaluation of enhanced external counter pulsation effectiveness on clinical profile and
health-related quality of life in coronary heart disease patients, Vikram Singh, G.
Kumari, Bimal Chhajer, A. Jhingan, S. Dahiya, Published 2018, Medicine
9. Effect of Enhanced External Counterpulsation (EECP) on Exercise Time Duration and
Functional Capacity in Patients with Refractory Angina Pectoris, January 2014, Journal
of Tehran University Heart Center 9(1):33-7
10. ISO 14971:2019 Medical devices – Application of risk management to medical devices,
2019-12.
11. Nasan Medical Electronics Pvt. Ltd: Nasan: India’s leading and reliable medical
electronics equipment (nasanmedical.com)
12. European Commission: CE marking (europa.eu)

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13. ISO - Standards
14. Standards | FDA
15. Central Drugs Standard Control Organization: home (cdsco.gov.in)
16. Medical device & diagnostics (cdsco.gov.in)
17. Holter, Event Loop Monitoring and Implantable Loop Recorder - Advanced Cardiology
and Primary Care LLC (advancedcardioprimary.com)
18. Holter/Loop Monitor From Home – Windsor Heart Institute
19. Holter Monitoring and Loop Recorders: From Research to Clinical Practice, Arrhythm
Electrophysiol Rev., Alessio Galli, Francesco Ambrosini, and Federico Lombardi,
2016 Aug; 5(2): 136–143.
20. Implantable loop recorder - Mayo Clinic

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