Internship Final report
Internship Final report
Internship Final report
PROJECT REPORT
ON
BY
Mr. Adesh Shantaram Temkar
2017 - 2022
A
PROJECT REPORT
ON
BY
Mr. Adesh Shantaram Temkar
2017 - 2022
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.
Adesh Temkar
Date:
Place: MIT School of Bioengineering Sciences & Research, Loni Kalbhor, Pune.
ACKNOWLEDGMENT
First and foremost, I gratefully acknowledge Dr. Renu Vyas, Head of department MIT School of
Bioengineering Sciences and Research, MIT ADT University, and Prof. Vinayak Ghaisas,
Director of MIT School of Bioengineering Sciences and Research, MIT ADT University for their
support, supervision, advice, lab facility and work environment in my progress as a student.
I am thankful and fortunate enough to get constant encouragement, support, and guidance from
all the Teaching staff of MIT SBSR, and MIT ADT University which helped me in successfully
completing my project work. Also, I would like to extend my sincere esteem to all staff in the
laboratory for their timely support.
The internship opportunity with Nasan Medical Pvt. Ltd. Pune was a great chance for learning
and professional development in a Healthcare environment. During the tenure of training at,
Pune. I learned about how the process in the D&D department is conducted from a commercial
point of view. Therefore, I consider myself very lucky as I was provided with an opportunity to
be a part of it. I am also grateful for getting a chance to meet so many wonderful people and
professionals who led me though this internship period.
I take this opportunity to express my deepest gratitude and special thanks to my guides Mr.
Yashwant Samant, CEO of Nasan Medical Pvt. Ltd., Mrs. Manjiri Date, Head of department
Design and development, Mrs. Vasudha Pawar, D&D engineer, and Mrs. Manisha Likhate, D&D
engineer for their valuable guidance. I am heartily thankful to him for providing his valuable
suggestions, guidance and teaching gave me the inspiration and interest to successfully complete
the project. I would also like to thank my colleagues Tejas Nakate, Bhagesh Chillah & Prakash
kudalkar, Sandip Patil, Imam Hawaldar for their valuable support and sharing their work
experiences throughout my dissertation period. I would also like to thank the administrative staff
of Nasan Medical Pvt. Ltd Pune for their support.
ABSTRACT
The medical device industry in India is ever-growing and lands fourth position in India and
amongst at top 30 in the world. As per statistics by the Bureau of Labour Statistics (BLS) in the
US, there were nearly 20,000 positions in the country in 2018 and estimated to grow at a rate of 4
percent by 2028. In India, medical technology is estimated to reach $50 billion by 2025. Several
schemes have been launched by the Indian government to promote an R&D and start-up culture
with regard to medical devices such as Production Linked Scheme (PLI) under the Atmanirbhar
Bharat mission. Working in Nasan Biomedical roles such as Product owner, Document executive,
and Quality assurance engineer. Working as a Quality Assurance Engineer – To inspect the
working of patient monitor, asaan, TeleCardia unit. To maintain the efficacy of the manufactured
products. As a Document Executive of the products. To regulate and update assembly Job Guides
as well as create new assembly Job Guides of the products. Filling input-output form as well as
annexure forms of respective products. Create and update packaging Job Guide. To learn the
purpose of electronic components like PCBs used in the different products. In my internship got
real experience on working on ISO 14971- 2019 document including Risk management file and
Usability file of Medical devices such as Patient Monitors, and ECG machine (Asaan, Esy-G,),
Along with that to learn about different medical patient parameters like electrocardiography,
plethysmography, spirometry, Automated external defibrillators, PACER, Invasive and non-
invasive blood pressure monitoring system, end-tidal carbon dioxide, and Heart/pulse rate..
➢ Collaborating with prospective users and clients to understand and anticipate their needs
and translate them into product requirements
➢ Defining the vision for the team’s product
➢ Overseeing all stages of product creation including design and development.
➢ Monitoring and evaluating product progress at each stage of the process
➢ Liaising with the product team and end-users to deliver updates.
➢ Participating in meetings and discuss on progress of regular product and upcoming
development of product.
➢ Adhering to regulatory requirements.
➢ Working with colleagues to ensure consistency of documentation practice across the
company.
➢ Training employees on efficient documentation usage. And Removing documents that are
obsolete
➢ Recording the results of your testing and observations for reference, including statistical
data about the quality of your product
Keywords: ISO 14971- 2019, Medical devices, Document executive, Quality assurance
engineer,
CONTENTS
Certificate i
Declaration ii
Acknowledgment iii
Abstract iv
Contents v
List of Figures vi
List of Tables vii
List of Abbreviations viii
2. Methodology
2.1 Telecardia 29
2.2 Asaan 40
2.3 Esy-G 45
4. Conclusion 59
Fig. Page
Details
No. No.
1.1 Anatomy of Heart 14
1.2 conduction system of Heart 16
1.3 Patient monitor 20
1.4 Classification of patient monitor 21
1.5 CMS panorama WiFi16 22
1.6 asaan 23
1.7 Telecardia 24
1.8 CellG-BT 25
1.9 Biphasic defibrillator 26
1.10 Stress test machine 27
1.11 Digital Holter 27
2.1 Installation of Telecardia 29
2.2 5 lead ECG cable 30
2.3 Leads placement on body 30
2.4 10 lead ECG cable 31
2.5 Leads placement on body 31
2.6 SPO2 probe 31
2.7 NIBP cuff 32
2.8 Temperature probe 32
2.9 Tab ON/OFF button 33
2.10 Monitoring mode screen 34
2.11 Monitoring mode screen (with values) 34
2.12 Gmail composer 35
2.13 12 lead ECG monitoring home screen 35
2.14 Patient search page screen 36
2.15 Registration page screen 36
2.16 Event log page screen 37
2.17 Acquisition screen 37
2.18 Gmail composer screen 37
2.19 Review test 38
2.20 Event log screen 38
2.21 Emergency log screen 39
2.22 12 lead ECG cable 41
2.23 Leads placement on body 41
2.24 Home screen 42
2.25 Patient search screen 42
2.26 Patient registration screen 43
2.27 Event log screen 43
2.28 Acquisition screen 43
2.29 Mopriya WiFi printing option 44
2.30 ECG screen 44
2.31 Median screen 44
2.32 Main screen 45
2.33 10 lead ECG cable 46
2.34 Leads placement 46
2.35 Home screen 47
2.36 Acquisition screen 47
2.37 ECG send message window 48
2.38 ECG send acknowledge messege screen 48
2.39 Home screen 48
2.40 Patient screen 49
2.41 Registration enabled screen 49
2.42 Patient registration screen 49
2.43 Patient details screen 50
2.44 Event log screen 50
2.45 Acquition screen 50
2.46 ECG report on Heartnet app 51
2.47 Patient history screen 52
2.48 Patient registration screen 52
2.49 Emergency log screen 53
2.50 Home screen 53
2.51 Patient registration screen 53
2.52 Patient searching screen 54
2.53 Review screen 54
2.54 Acknowledgement message to doctor 55
2.55 Heartnet app screen 55
2.56 Patient report review screen 56
2.57 Gmail composer screen 56
3.1 Monitoring and 12 lead ECG report on A4 paper 57
3.2 Resting ECG and All leads measurement report on A4 paper 57
3.3 Report on Heartnet app 58
3.4 Resting ECG report on A4 paper 58
LIST OF TABLES
Table Page
Details
No. No.
NASAN is not only the first but also the only Indian manufacturer of many of the above
products-Biphasic Defibrillators and Digital Holter
Recorders.
Increasing demand of Biomedical instrument in india will beneficial to Indian Healthcare
sector. Rising number of medical facilities will boost the demand for medical devices in the
market. Various government initiatives such as ‘Production Linked Incentives (PLI) Scheme
for Medical Devices 2020’ and establishing medical parks will augment demand. The medical
technology sector in India is projected to reach US$ 50 billion by 2025.
In October 2021, the government announced plan to draft a new drugs, cosmetics and
medical devices bill to increase the acceptability of Indian medical devices in the global
market.
1.2 General description of Heart:
Circulatory system, which is made up of a network of blood arteries that pumps blood
throughout your body, is led by your heart. It also collaborates with other physiological
systems to keep your blood pressure and heart rate in check. Your heart's performance is
influenced by your family history, personal health history, and lifestyle. The heart is a fist-
sized organ that is responsible for pumping blood throughout your body. It's your circulatory
system's principal organ.
Your heart is comprised of four main portions (chambers) that are powered by electrical
impulses and are formed of muscle. Your heart's function is controlled by your brain and
nerve system.
The parts of your heart are like the parts of a house. Your heart has:
• Walls.
• Chambers (rooms).
• Valves (doors).
• Blood vessels (plumbing).
• Electrical conduction system (electricity).
Your heart’s conduction system is like the electrical wiring of a house. It controls the rhythm
and pace of your heartbeat. It includes:
Sinoatrial (SA) node: Sends the signals that make your heartbeat.
Atrioventricular (AV) node: Carries electrical signals from your heart’s upper chambers to its
lower ones.
Your heart also has a network of electrical bundles and fibers. This network includes:
Heart conditions are among the most common types of disorders affecting people. In the United
States, heart disease is the leading cause of death for people of all genders and most ethnic and
racial groups.
The cardiac conduction system is made up of nodes and specialised conduction cells that control
and trigger heart muscle contractions. It consists of the following components:
• Sinoatrial node
• Atrioventricular node
• Atrioventricular bundle (bundle of His)
• Purkinje fibres
The sequence of electrical events during one full contraction of the heart muscle:
An excitation signal (an action potential) is created by the sinoatrial (SA) node. The wave of
excitation spreads across the atria, causing them to contract. Upon reaching the atrioventricular
(AV) node, the signal is delayed. It is then conducted into the bundle of His, down the
interventricular septum. The bundle of His and the Purkinje fibres spread the wave impulses
along the ventricles, causing them to contract.
Sinoatrial Node
The sinoatrial (SA) node is a collection of specialised cells (pacemaker cells), and is located in
the upper wall of the right atrium, at the junction where the superior vena cava enters. These
pacemaker cells can spontaneously generate electrical impulses. The wave of excitation created
by the SA node spreads via gap junctions across both atria, resulting in atrial contraction (atrial
systole) – with blood moving from the atria into the ventricles. The rate at which the SA node
generates impulses is influenced by the autonomic nervous system:
Sympathetic nervous system – increases firing rate of the SA node, and thus increases heart rate.
Parasympathetic nervous system – decreases firing rate of the SA node, and thus decreases heart
rate.
Atrioventricular Node
After the electrical impulses spread across the atria, they converge at the atrioventricular node –
located within the atrioventricular septum, near the opening of the coronary sinus. The AV node
acts to delay the impulses by approximately 120ms, to ensure the atria have enough time to fully
eject blood into the ventricles before ventricular systole. The wave of excitation then passes from
the atrioventricular node into the atrioventricular bundle.
Atrioventricular Bundle
The atrioventricular bundle (bundle of His) is a continuation of the specialised tissue of the AV
node and serves to transmit the electrical impulse from the AV node to the Purkinje fibres of the
ventricles. It descends the membranous part of the interventricular septum, before dividing into
two main bundles:
Right bundle branch – conducts the impulse to the Purkinje fibres of the right ventricle
Left bundle branch – conducts the impulse to the Purkinje fibres of the left ventricle.
Purkinje Fibres
The Purkinje fibers (sub-endocardial plexus of conduction cells) are a network of specialized
cells. They are abundant with glycogen and have extensive gap junctions. These cells are located
in the subendocardial surface of the ventricular walls and are able to rapidly transmit cardiac
action potentials from the atrioventricular bundle to the myocardium of the ventricles. This rapid
conduction allows coordinated ventricular contraction (ventricular systole) and blood is moved
from the right and left ventricles to the pulmonary artery and aorta respectively.
1.2.3. Electrocardiogram:
An electrocardiogram is a simple, painless test that measures your heart’s electrical activity.
It’s also known as an ECG or ECG. Every heartbeat is triggered by an electrical signal that
starts at the top of your heart and travels to the bottom. Heart problems often affect the heart’s
electrical activity.
Measuring the electrical activity of the heart may help your doctor determine if chambers of
the heart are possibly too large or overworked. In other cases, an ECG can help determine the
cause of your symptoms along with what type of treatment might be necessary.
If you have a family history of heart disease, your doctor may also order an ECG to look for
early signs of heart disease. No matter your age, it’s important to be aware of any symptoms
that may indicate a heart problem and talk with a doctor about possibly scheduling an ECG.
Types of electrocardiograms
An ECG records a picture of your heart’s electrical activity for the time that you’re being
monitored. However, some heart problems come and go. In these cases, you may need longer
or more specialized monitoring.
Stress test
Some heart problems only appear during exercise. During stress testing, you’ll have a
continuous ECG while you’re exercising. Typically, this test is done while you’re on a
treadmill or stationary bicycle.
Holter monitor
Also known as an ambulatory ECG or ECG monitor, a Holter monitor records your heart’s
activity over 24 to 48 hours or up to 2 weeks while you maintain a diary of your activity to
help your doctor identify the cause of your symptoms. Electrodes attached to your chest
record information on a portable, battery-operated monitor that you can carry in your pocket,
on your belt, or on a shoulder strap.
Event recorder
Symptoms that don’t happen very often may require an event recorder. It’s like a Holter
monitor, but it records your heart’s electrical activity just when symptoms occur. Some event
recorders activate automatically when they detect arrhythmia. Other event recorders require
you to push a button when you feel symptoms. You can send the information directly to your
doctor over a phone line.
Loop recorder
A loop recorder is a device that functions as an electrocardiogram would but allows for
continuous remote monitoring of your heart’s electrical signals. It’s looking for irregularities
that can cause fainting or palpitations.
• Irregular heartbeat: heart defects, including an enlarged heart, a lack of blood flow, or
birth defects electrolyte problems, chamber dilation, chamber hypertrophy, or how
electricity is moving through the heart blocked arteries, or coronary artery disease
• If the test shows signs of these abnormalities, your doctor will go over options to
improve your heart’s condition. This may include prescribing medication or
suggesting lifestyle changes such as modifying your diet or exercising more.
1.3 Product Description:
1.3.1 Multipara Monitor:
The intended use of this device is a portable (intra-hospital) multiparameter unit designed for
monitoring, recording of, and generating alarms for adult, pediatric, and neonate patient vital
signs in a hospital environment. Patient Monitor monitors and displays oscillometric-invasive
blood pressure (systolic, diastolic, and mean arterial pressure), heart/pulse rate, respiration rate,
ECG, temperature, and functional oxygen saturation (SpO2) and pulse rate via spot-checking and
continuous monitoring.
The Monitor is intended for use under the direct supervision of a licensed health care practitioner.
The monitors are additionally intended for use in transport situations within the hospital
environment. The monitors are only for use on one patient at a time. Patient Monitor also detects
alarm limit conditions . Using this monitor a clinician can view, and record clinical data derived
from each parameter. The critical outputs obtained from monitoring are required to be reviewed
and verified by Clinical Experts by referring to other clinical symptoms or using other clinical
means before any conclusion.
• ECG
• SPO2
• NIBP
• Respiration
• Temperature
• EtCO 2
Product Features
• Highly user-friendly.
• Easy access to all the functions and settings of parameters through the encoder
• Monitoring of ECG, SpO2 and NIBP, Respiration, Temperature, and EtCO2 of a patient.
• View the trends of the past 24 hours.
• Display ECG waveform, heart rate (HR), Plethysmograph, SpO2%, and NIBP i.e.
systolic, diastolic and mean values, respiration waveform, respiration rate, temperature
values, and
EtCO2.
• Three modes for NIBP Manual, Auto & STAT, and 3 patient types i.e. Adult,
Neonatal, and Pediatric.
• It displays a countdown of the time interval for Auto mode; it also displays Cuff pressure.
• Facility to change parameter settings like gain and sweep speed of ECG waveform.
• Facility to have user-definable limits and settings of parameters as well as default settings.
ECG machine is mainly intended to use in a hospital environment, for providing preliminary
treatment to cardiac patient by the clinically qualified personnel trained for operating critical
medical operations
The 12-channel electrocardiograph of the ECG machine is intended to use acquire and transmit
the electrical signal at the body surface to a processor that produces an electrocardiogram (ECG).
It acquires and records 12 channel electrocardiographic waveforms to interpret the condition of
Heart of the patient. The critical outputs obtained from monitoring are required to be reviewed
and verified by Clinical Experts by referring to other clinical symptoms or using other clinical
means before any conclusion.
Specification:
• Comparing the latest ECG with the old one is at a click of the button
• Save paper cost by printing on A4 plain paper & emergency print out on 55mm thermal
printer
• Go Green! by selective printouts in ICU, wards, and camps
• With 10000 ECG memory storage, freedom of not taking printout if not required
• Send ECG through Email for a second opinion
• Facility to overwrite measurement and interpretation
1.3.4 Esy-G:
NASAN has launched the Esy-G product, and provides service as Heartnet app which enables a
direct and easy data exchange between the junior doctor and the senior doctor through the inter-
net. This technology promises quick referral and quality data provision to the senior doctor and,
in turn, quality diagnosis to the patients approaching their respective junior doctor.
The junior doctor will wirelessly transfer the data to the senior doctor. The data will be forwarded
through the Heart-net server. On the arrival of the data, the Heart-net server will send a text-
message (SMS) to the senior doctor on his phone. And senior doctor will receive notification.
The senior doctor can then use his Mobile to view the ECG with “Heartnet” app. On accessing
and studying the ECG, the senior doctor can enter his comments online and send the report back
through the Heart-net server to the junior doctor. This will be intimated to junior doctor by SMS
on his mobile.
Specification:
1.3.5 TeleCardia
Tele-Cardia machine provides the facility to display 5 parameters in patient monitoring such as
• ECG (5 lead and 12 lead ECG)
• Spo2
• NIBP
• Temperature
• Respiration rate
And sends this data directly to the respective doctor or clinicians via email. As well as also
provides the facility to record and generate pdf files of twelve-channel ECG reports on A4 paper
with measurement & interpretation. And send to respective doctors or clinicians via email.
Tele-Cardia takes full advantage of today's digital technology and has been built to perform
reliably for a long time. It is controlled by a microcontroller.
1.3.6 CellG_BT
• CellG_BT is the new upcoming product of NASAN Company. Now it is in the develop-
ing stage.
• It’s a combination of hardware and software. Also, it’s a portable device and a very small
size we can carry this device in our pocket also.
• It is an ECG device. By using leads we can capture the ECG and the best part is we can
see ECG reports on our phone by simply installing the CellG_BT app.
• CellG-BT records 12 lead ECG of patient and display on mobile screen, then we can send
data to respective doctor or clinician via email.
• Also provide the facility to directly send for print as well as we can mail this ECG graph
to the physicians or clinicians.
ISO 14971 is a risk management standard for medical devices. It defines the rules and
describes procedures that the manufacturers of medical devices, including software, have
to adhere to concerning risk management. The aim of ISO 14971 is to help the
manufacturers identify, estimate, evaluate, monitor, and control risk associated with a
medical device. It also helps minimize risk by giving guidance on how to check whether
the control measures were implemented correctly.
ISO 14971 specifies that the risk management process should be iterative and
implemented at every stage of product manufacturing: from the very beginning to the end
of a product lifecycle. Risk management should be managed not only during the
manufacturing and implementation of medical devices but also after they are released to
the end users.
Section 2: Methodology
2.1 TeleCardia:
2.1.1 Step to prepare Telecardia unit:
• Prepare the patient’s skin before applying monitoring electrodes. Skin is a poor conduc-
tor of electricity, so skin preparation is important in achieving good electrode-to-skin
contact.
• Identify the appropriate electrode sites.
• If necessary, clip hair at the electrode sites (or shave sites if needed).
• Clean and abrade the skin at the electrode site.
• Dry the electrode sites briskly to increase capillary blood flow in the tissues and to re-
move oil and skin cells.
• Apply some jelly to the electrode site and thoroughly rub the site with gauze till it be-
comes slightly red. This removes the horny non-conducting layer of the epidermis ena-
bling good electric contact with the body fluids.
• Remove all the traces of jelly by wiping the abraded site with a warm dry cloth and
completely drying up the site with a dry towel. The skin must be clean, dry, and com-
pletely free of jelly for the electrodes to remain well in position till the end of ECG ac-
quisition. If the jelly 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 center out. Repeat this procedure for all sites.
• Connect the 5-lead ECG patient cable to the Telecardia unit and then connect it to the
respective electrodes
Fig. 2.2 5 lead ECG cable Fig. 2.3 leads placement on body
RA/W Directly below the clavicle and near the right shoulder.
RA/W Directly below the clavicle and near the left shoulder.
Fig. 2.4 10 lead ECG cable Fig. 2.5 leads placement on body
cable
The temperature sensor used is surface temperature probe. Apply the temperature probe on
the area of the human body where the temperature needs to be measured. Normally it is
placed under the armpit or on the elbow. The placement is decided by trained medical
professional.
3) Turn On the Tab ON/ OFF switch. Use the button shown in the below figure to turn on the
screen and wait till complete boot.
4) Once the screen is completely ON, connect unit to WiFi
5) Add your Gmail account in the Gmail application to use the email facility in Tele-Cardia.
6) Insert Fuse in the fuse holder.
7) Connect the adaptor to the mains and switch ON the mains supply.
8) Now switch ON by pressing the ON/OFF switch of the machine.
Monitoring Mode:
- Spo2 %
- Respiration Rate
- Temperature value
4) Just below the save tab there is Heart value is present, by clicking on ‘HR’ it converts into
‘PR value’ and vice versa.
5) After getting all the parameters, click on the save button, the page redirects to the email,
and the following screen will appear. In that enter respective doctor or clinician email Id.
And press sends button.
12 lead ECG:
1. Click on 12 lead ECG mode, following screen will appear.
5. You can view the patient list by clicking the ‘search’ button or Entering patient details like
patient name, DOB, mobile number to search particular patient.
6. After entering patient details, click on the search button, this will provide you registered pa-
tient with the same details. If a patient with the same details is not registered, then the mes-
sage “No records found” will appear on the screen.
7. You can do registration by entering the personal patient details. Click on the ‘Update’ button
to register the patient.
9. Press the “New ECG” button, you can view the ECG of the patient on the acquisition screen
where 12 leads are displayed in 6 X 2 channel format as shown below.
10. In the acquisition screen, the save button gets enabled after 10 sec, click on the “Save”
button. This page redirects to the Gmail app. And here you can enter the respective doctor or
clinician email Id.
13. You can see the log and status of the ECG in “Review tests” window as shown below.
13. In an emergency case, you can take the ECG without doing registration by pressing the
emergency button on the main screen. When the emergency is pressed acquisition screen
will appear and the “save” button is enabled after 10 sec & ECG data of the patient will be
saved. And the page redirects to the Gmail account. If the “exit button on the emergency ac-
quisition screen is pressed, then the test conducted is not saved.
14. You can link the emergency data by clicking on the patient name and clicking ‘select’ fol-
lowing screen will appear.
15. Click on the ‘link emergency’ button following screen will appear. By simply clicking on
‘Link’. ECG data will link with a particular patient
Fig. 2.21 Emergency log screen
2.2 asaan
2.2.1 Step to prepare asaan unit:
5. After entering patient details, Click on search button, this will provide you registered pa-
tient with the same details. If patient with same details is not registered then message “No
records found” will appear on screen.
6. You can do registration by entering the personal patient details. Click on ‘Update’ button
to register the patient.
7. There are Compulsory Fields ‘*’ – These fields are mandatory.
Fig2.26: Patient registration screen
9. Press “New ECG” button, You can view the ECG of patient on the acquisition screen
where 12 leads are displayed in 6 X 2 channel format as shown below.
12. When you click on “Save” button, as per set ECG mode in configuration median screen
OR ECG screen will be displayed.
Preparation of Patient:
• Prepare the patient’s skin before applying monitoring electrodes. Skin is a poor conduc-
tor of electricity, so skin preparation is important in achieving good electrode-to-skin
contact.
• Identify the appropriate electrode sites.
• If necessary, clip hair at the electrode sites (or shave sites if needed).
• Clean and abrade the skin at the electrode site.
• Dry the electrode sites briskly to increase capillary blood flow in the tissues and to re-
move oil and skin cells.
• Apply some jelly to the electrode site and thoroughly rub the site with gauze till it be-
comes slightly red. This removes the horny non-conducting layer of the epidermis ena-
bling good electric contact with the body fluids.
• Remove all the traces of jelly by wiping the abraded site with a warm dry cloth and
completely drying up the site with a dry towel. The skin must be clean, dry, and com-
pletely free of jelly for the electrodes to remain well in position till the end of ECG ac-
quisition. If the jelly 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 center out. Repeat this procedure for all sites.
• Connect the 5-lead ECG patient cable to the Telecardia unit and then connect it to the
respective electrodes
Leads position for 10 lead ECG:
2) The green button in the corner of the screen shows that the device is in online mode. i.e is
connected to an active network.
3) The grey button with cross in the corner of the screen shows that the device is in Offline
mode. i.e is not connected to an active network.
4) Emergency patient: - When patient with emergency comes to the doctor/cardiologist,
emergency ECG can be taken with emergency button.
9) Enter details name, middle name, last name, mobile number and birth date to search the
particular patient
10) If patient with same details is not registered then message “No records found” will appear
on screen.
11) For new patient, register patient by pressing button ‘Register new’.
Fig 2.42 Patient registration screen
12) You can do registration by entering the personal patient details. Click on ‘Update’ button
to register the patient.
13) If ‘Short Details’ checkbox from configuration is checked then only mandatory fields will
appear in the new registration window
15) New ECG of new patient, Press “New ECG” button to take new ECG.
16) You can see the ECG of patient on the acquisition screen where 12 leads are displayed in
6 channel formats as shown below.
20) The Heartnet app is installed in the phone, and voice notification is heard as following
“Dear Doctor, New ECG from Heartnet”
Click on the app icon to see view the ECG.
24) Patient details: - Patient details can be edited with patient details button. When patient
details button is pressed, following screen will appear.
28) Existing Patient for regular checkup: - When patient comes for regular check up and he is
existing patient, click on patient button on the following screen.
31) Enter details name, middle name, last name, mobile number and birth date to search the
patient
32) After entering patient details, click on search button, this will provide you registered pa-
tient with the same details.
33) When existing patient comes, this patient will be displayed in search result as shown be-
low.
36) Then Doctor can take ECG of Patient. You can follow the steps given under heading
“New Patient for regular checkup”.
37) Review tests: You can see the log and status of the ECG in “Review tests” window as
shown below.
38) After sending data, following message goes to senior doctor with Voice notification, with that
he/she can view the ECG of patient in ‘heartnet’ app. Doctor can send the comments from
this app. Image below shows the screenshot of the application.
Fig 2.54 Acknowledgement message to Doctor
39) After receiving comments, Status of ECG will change in review tests log. Click on ‘View
report’ to take thermal print or A4 print with the comments.
Note: When Print A4 is clicked email page will get open, as shown below, click on send to
give the A4 print.
➢ Send to Email: The senders email address can be configured in the ‘Configuration menu’
➢ Back: If back is pressed, view report screen will open, and email will not be sent.
Results
3.1 Telecardia reports:
Fig 3.2 Resting ECG and All leads measurement report on A4 paper
3.3 Esy-G reports:
Fig 3.3 Report on Heartnet app Fig. 3.4 Resting ECG report on A4 paper
CONCLUSION
The internship gave us a wide view of different biomedical devices which in turn opened the
treasure of knowledge regarding how the healthcare sectors work. The medical industry has
a very diverse field. In internship understand the need of medical devices and how vast the
medical industry is. In India, the medical industry will be the booming industry in the next 5
years. I was work on different projects such as Telecardia and, CellG-BT, and learned many
new things from design and development to the marketing of the product. As well as work as
a product owner of patient monitor, Asaan, & Esy-G products. Working as a product owner
did regular monitoring and new development in the product as per the customer request. This
task gave me the importance of upgradation of the system and products from a marketing
perspective. Quality assurance engineer is also a very interesting task in the medical field, in
that we have to have ensure the product is safe for a patient. And safe for a doctor as well.
Along with the medical devices got the importance of the documents as well as certification.
The medical industry is not only about the manufacturing and marketing of medical devices
but is also so much bigger than that. Quality check is also a big factor in medical devices.
Including quality assurance, quality control, purchasing components required for
manufacturing the product, and Administration of all departments.
These diversifying approaches in the internship gave me a broad idea of the medical
industry, learned more and more about technical knowledge as well as got an idea about
exactly how a company run, from manufacturing to marketing, from dealer to end customers.
Interact with customers gave the idea about what customers want. This is done only when
there is proper support orientation, enough supports, choose the correct expansion and
orientation the restorations and this is achieved with the help of the software’s and
technology.
During the internship got opportunity to interact with different professionals from different
institutions, companies, and services. In addition, gave a whole lot prospective about how to
reach the potential customers and how interact with them making a product keeping the
criteria and requirement of the targeted customers in mind. a positive attitude while
preaching is what plays an important role, but the patience will always remain the key to
success.
References and bibliography
➢ https://www.nasanmedical.com/
➢ https://my.clevelandclinic.org/
➢ https://www.ncbi.nlm.nih.gov/books/NBK83160/
➢ https://medlineplus.gov/ency/anatomyvideos/000021.htm
➢ https://teachmeanatomy.info/thorax/organs/heart/conducting-system/
➢ https://teachmeanatomy.info/thorax/organs/heart/conducting-system/