The document describes a cardiovascular monitoring system (CMS) that measures blood pressure, heart rate, and blood oxygen levels. It operates by using light sensors on the finger to non-invasively measure these vital signs. The data is wirelessly transmitted to a base monitor and can be viewed or programmed by a physician using software. The CMS is intended for at-home patient monitoring under a doctor's supervision. It functions similarly to previously cleared predicate devices and a comparison table shows the CMS has substantially equivalent intended use, technological characteristics, and accuracy to predicates.
Body Temperature & Blood Pressure Remote MonitoringIJMTST Journal
In this paper we present an electronic system to perform a non-invasive measurement of the blood pressure based on the oscillometric method, which does not suffer from the limitations of the well-known auscultatory one. With reference to other similar devices, a great improvement of our measurement system is achieved since it performs the transmission of the systolic and diastolic pressure values to a remote computer. This aspect is very important when the simultaneous monitoring of multi-patients is required. Blood pressure readings with help of developed algorithm has been calculated and transmitted via Bluetooth kit to the stationary computer. Numerical reading values of systolic and diastolic blood pressure remotely recorded and displayed with help of LCD as well stationary computer.
Now-a-days, a growing number of people in a developing countries like India forces to look for new solutions for the continuous monitoring of health check-up. It has become a necessity to visit hospitals frequently for doctor’s consultation, which has become financially related and a time consuming process. To overcome this situation, we propose a design to monitor the patient’s health conditions such as heart beat, temperature, ECG and BP and send the message to guardian using GSM. In the recent development of internet of things(IoT) makes all objects interconnected and been recognized as the next technical revolution. Patient monitoring is one of the IoT application to monitor the patient health status. Internet of things makes medical equipments more efficient by allowing real time monitoring of health. Using IoT doctor can continuously monitor the patient’s on his smart phone and also the patient history will be stored on the web server and doctor can access the information whenever needed from anywhere.
During treatment, it is highly important to continuously monitor the vital physiological signs of the patient. Therefore , patient monitoring systems has always been occupying a very important position in the field of medical devices.
The continuous improvement of technologies not only helps us transmit the vital physiological signs to the medical personnel but also simplifies the measurement and as a result raises the monitoring efficiency of patients.
With rapid development of economies, growth of aging population and the prevalence of chronic diseases across the world, there is an urgent need to find new ways to improve patient outcomes, increase access to care, and reduce the cost of medical care. A health care monitoring system is necessary to constantly monitor patient’s physiological parameters. The tele-medical system focuses on the measurement and evaluation of vital parameters e.g. temperature, electrocardiogram (ECG), heart rate variability, fall detection etc. This will enable doctors and care givers to observe patients without having to be physically present at their bedside, be it in the hospital or in their home.
A Wireless Methodology of Heart Attack Detectionijsrd.com
The wrist watch with Heart Attack Detection is equipment that is used daily to indicate heart condition, to detect heart attack and to call for emergency help. It was designed specially to help patients with heart disease.This includes three common sub units. They are Circuit, Analysis Algorithm, and Bluetooth Communication. The first one is to wear on the wrist of the patient to captures the abnormal heart beat waves from the victim and the alternate methods are installed under the stick. This project is based on the previous project “Wireless Heart Attack Detector with GPS†of Fall 2004 [1]. we consider a big improvement in reducing the complexity of the project greatly, in saving power consumption of the project to run much fewer codes and in making the project to run at a faster time. No wire is attached to the wrists. In our project, the ECG waveform is transmitted wirelessly from the wrists to the watch. This gives the user great flexibility while the program is switched on and running. User can drive safely, can use restroom easily and can function normally like without the project. Previous project had the wire connection. All the hardware on the walking watch would have been strapped to the wrists. This will not make the project functional and marketable. Our project is completely portable. Heart condition is displayed in our project. The previous project did not inform the user about his heart condition. We display the heart condition through two LEDs as low-risk (alert level between 4 and 6) and high risk (alert level between 7 and 9). The user can know their heart condition and take proper action to avoid the fatal moment. Proper action could be slowing down and taking a rest.
Body Temperature & Blood Pressure Remote MonitoringIJMTST Journal
In this paper we present an electronic system to perform a non-invasive measurement of the blood pressure based on the oscillometric method, which does not suffer from the limitations of the well-known auscultatory one. With reference to other similar devices, a great improvement of our measurement system is achieved since it performs the transmission of the systolic and diastolic pressure values to a remote computer. This aspect is very important when the simultaneous monitoring of multi-patients is required. Blood pressure readings with help of developed algorithm has been calculated and transmitted via Bluetooth kit to the stationary computer. Numerical reading values of systolic and diastolic blood pressure remotely recorded and displayed with help of LCD as well stationary computer.
Now-a-days, a growing number of people in a developing countries like India forces to look for new solutions for the continuous monitoring of health check-up. It has become a necessity to visit hospitals frequently for doctor’s consultation, which has become financially related and a time consuming process. To overcome this situation, we propose a design to monitor the patient’s health conditions such as heart beat, temperature, ECG and BP and send the message to guardian using GSM. In the recent development of internet of things(IoT) makes all objects interconnected and been recognized as the next technical revolution. Patient monitoring is one of the IoT application to monitor the patient health status. Internet of things makes medical equipments more efficient by allowing real time monitoring of health. Using IoT doctor can continuously monitor the patient’s on his smart phone and also the patient history will be stored on the web server and doctor can access the information whenever needed from anywhere.
During treatment, it is highly important to continuously monitor the vital physiological signs of the patient. Therefore , patient monitoring systems has always been occupying a very important position in the field of medical devices.
The continuous improvement of technologies not only helps us transmit the vital physiological signs to the medical personnel but also simplifies the measurement and as a result raises the monitoring efficiency of patients.
With rapid development of economies, growth of aging population and the prevalence of chronic diseases across the world, there is an urgent need to find new ways to improve patient outcomes, increase access to care, and reduce the cost of medical care. A health care monitoring system is necessary to constantly monitor patient’s physiological parameters. The tele-medical system focuses on the measurement and evaluation of vital parameters e.g. temperature, electrocardiogram (ECG), heart rate variability, fall detection etc. This will enable doctors and care givers to observe patients without having to be physically present at their bedside, be it in the hospital or in their home.
A Wireless Methodology of Heart Attack Detectionijsrd.com
The wrist watch with Heart Attack Detection is equipment that is used daily to indicate heart condition, to detect heart attack and to call for emergency help. It was designed specially to help patients with heart disease.This includes three common sub units. They are Circuit, Analysis Algorithm, and Bluetooth Communication. The first one is to wear on the wrist of the patient to captures the abnormal heart beat waves from the victim and the alternate methods are installed under the stick. This project is based on the previous project “Wireless Heart Attack Detector with GPS†of Fall 2004 [1]. we consider a big improvement in reducing the complexity of the project greatly, in saving power consumption of the project to run much fewer codes and in making the project to run at a faster time. No wire is attached to the wrists. In our project, the ECG waveform is transmitted wirelessly from the wrists to the watch. This gives the user great flexibility while the program is switched on and running. User can drive safely, can use restroom easily and can function normally like without the project. Previous project had the wire connection. All the hardware on the walking watch would have been strapped to the wrists. This will not make the project functional and marketable. Our project is completely portable. Heart condition is displayed in our project. The previous project did not inform the user about his heart condition. We display the heart condition through two LEDs as low-risk (alert level between 4 and 6) and high risk (alert level between 7 and 9). The user can know their heart condition and take proper action to avoid the fatal moment. Proper action could be slowing down and taking a rest.
A Low Cost Wearable Medical Device for Vital Signs Monitoring in Low-Resource...IJECEIAES
Medical devices are often expensive, so people in low-income countries cannot afford them. This paper presents the design of a low-cost wearable medical device to measure vital signs of a patient including heart rate, blood oxygen saturation level (SpO2) and respiratory rate. The wearable medical device mainly consists of a microcontroller and two biomedical sensors including airflow thermal sensor to measure respiratory rate and pulse oximeter sensor to measure SpO2 and heart rate. We can monitor the vital signs from a smartphone using a web browser through IEEE802.11 wireless connectivity to the wearable medical device. Furthermore, the wearable medical device requires simple management to operate; hence, it can be easily used. Performance evaluation results show that the designed wearable medical device works as good as a standard SpO2 device and it can measure the respiratory rate properly. The designed wearable medical device is inexpensive and appropriate for low-resource settings. Moreover, as its components are commonly available in the market, it easy to assembly and repair locally.
This is a presentation of our final year project of Biomedical Engineering course on Cuffless blood pressure monitoring. A new technology recently developed. We have tried to develop a model for the same.
IJERA (International journal of Engineering Research and Applications) is International online, ... peer reviewed journal. For more detail or submit your article, please visit www.ijera.com
Report on Automatic Heart Rate monitoring using Arduino UnoAshfaqul Haque John
Automatic heart rate monitoring using Arduino. This is a report based on project. It includes the circuit diagram and the PCB layout diagram of the circuit
Health monitoring is the major problem in today’s world. Due to lack of proper health monitoring, patient suffer from serious health issues. There are lots of IoT devices now days to monitor the health of patient over internet. Health experts are also taking advantage of these smart devices to keep an eye on their patients. With tons of new healthcare technology start-ups, IoT is rapidly revolutionizing the healthcare industry.
Here in this project, we will make an IoT based Health Monitoring System which records the patient heart beat rate and body temperature and also send an email/SMS alert whenever those readings goes beyond critical values. Pulse rate and body temperature readings are recorded over ThingSpeak and Google sheets so that patient health can be monitored from anywhere in the world over internet. A panic will also be attached so that patient can press it on emergency to send email/sms to their relative
Microcontroller Based Heart Beat and Temperature Monitoring System using Fing...xpressafridi
The basic idea behind this project is that anyone can stay connected with the doctor 24 hrs. It continuously provides following information to doctors.
Heart pulse rate
Temperature of human body
Portable ECG Monitoring System using Lilypad And Mobile Platform-PandaBoardIJSRD
New wireless system for biomedical purposes gives new possibilities for monitoring of essential function in human being. Wearable biomedical sensors will give the patient the freedom to be capable of moving readily and still be under continuously monitoring regularity of heartbeats identify any damage to the heart and devices used to regulate the heart and thereby to better quality of patient care. This paper describes a new concept for wireless and portable electrocardiogram (ECG) sensor transmitting signals to a monitoring station at the remote location within specific range, and this concept is intended for monitoring people with impairments in their cardiac activity. The proposed work helps to overcome this problem. With the advancement in Arduino and mobile technology, it is possible to design a portable ECG device which capture ECG of patient and monitor it on mobile platform. This report goes over low power Arduino, mobile platform Panda board and Zigbee technology to couple ECG over mobile board.
A Low Cost Wearable Medical Device for Vital Signs Monitoring in Low-Resource...IJECEIAES
Medical devices are often expensive, so people in low-income countries cannot afford them. This paper presents the design of a low-cost wearable medical device to measure vital signs of a patient including heart rate, blood oxygen saturation level (SpO2) and respiratory rate. The wearable medical device mainly consists of a microcontroller and two biomedical sensors including airflow thermal sensor to measure respiratory rate and pulse oximeter sensor to measure SpO2 and heart rate. We can monitor the vital signs from a smartphone using a web browser through IEEE802.11 wireless connectivity to the wearable medical device. Furthermore, the wearable medical device requires simple management to operate; hence, it can be easily used. Performance evaluation results show that the designed wearable medical device works as good as a standard SpO2 device and it can measure the respiratory rate properly. The designed wearable medical device is inexpensive and appropriate for low-resource settings. Moreover, as its components are commonly available in the market, it easy to assembly and repair locally.
This is a presentation of our final year project of Biomedical Engineering course on Cuffless blood pressure monitoring. A new technology recently developed. We have tried to develop a model for the same.
IJERA (International journal of Engineering Research and Applications) is International online, ... peer reviewed journal. For more detail or submit your article, please visit www.ijera.com
Report on Automatic Heart Rate monitoring using Arduino UnoAshfaqul Haque John
Automatic heart rate monitoring using Arduino. This is a report based on project. It includes the circuit diagram and the PCB layout diagram of the circuit
Health monitoring is the major problem in today’s world. Due to lack of proper health monitoring, patient suffer from serious health issues. There are lots of IoT devices now days to monitor the health of patient over internet. Health experts are also taking advantage of these smart devices to keep an eye on their patients. With tons of new healthcare technology start-ups, IoT is rapidly revolutionizing the healthcare industry.
Here in this project, we will make an IoT based Health Monitoring System which records the patient heart beat rate and body temperature and also send an email/SMS alert whenever those readings goes beyond critical values. Pulse rate and body temperature readings are recorded over ThingSpeak and Google sheets so that patient health can be monitored from anywhere in the world over internet. A panic will also be attached so that patient can press it on emergency to send email/sms to their relative
Microcontroller Based Heart Beat and Temperature Monitoring System using Fing...xpressafridi
The basic idea behind this project is that anyone can stay connected with the doctor 24 hrs. It continuously provides following information to doctors.
Heart pulse rate
Temperature of human body
Portable ECG Monitoring System using Lilypad And Mobile Platform-PandaBoardIJSRD
New wireless system for biomedical purposes gives new possibilities for monitoring of essential function in human being. Wearable biomedical sensors will give the patient the freedom to be capable of moving readily and still be under continuously monitoring regularity of heartbeats identify any damage to the heart and devices used to regulate the heart and thereby to better quality of patient care. This paper describes a new concept for wireless and portable electrocardiogram (ECG) sensor transmitting signals to a monitoring station at the remote location within specific range, and this concept is intended for monitoring people with impairments in their cardiac activity. The proposed work helps to overcome this problem. With the advancement in Arduino and mobile technology, it is possible to design a portable ECG device which capture ECG of patient and monitor it on mobile platform. This report goes over low power Arduino, mobile platform Panda board and Zigbee technology to couple ECG over mobile board.
Investimenti, consigli
davvero disinteressati? Questa
norma di trasparenza elimina alla radice
il conflitto di interessi tra gli intermediari
che vendono i prodotti e i risparmiatori
che pensano di ricevere un consiglio
disinteressato. La sua applicazione anche
Italia sarebbe la panacea per distinguere
in maniera chiara e trasparente
chi, come i consulenti finanziari
indipendenti, fa pura consulenza ed è
pagato per questo servizio solo dallo
stesso cliente da chi propone i prodotti
del proprio campionario e viene pagato
per questa attività di collocamento.La settimana scorsa ho partecipato al
Salone del Risparmio di Milano ed assistendo
ad una delle conferenze con i
rappresentanti di alcune delle società di
gestione del risparmio italiane sono rimasto
sorpreso da alcune affermazioni che, al
di là delle dichiarazioni d’intenti, segnalano
la distanza tra gli interessi delle stesse e i
risparmiatori. La prima è che le società di
gestione dovrebbero seguire “la moda”
confezionando il prodotto che investe nel
settore di volta in volta sulla cresta dell’onda.
Intendiamoci non c’è nulla di sbagliato
nel proporre nuovi strumenti, ma
assecondare gli investitori che seguono il
gregge e si lanciano nell’asset di moda
significa abdicare a quel ruolo di consulenza
che le reti di distribuzione finanziarie
dicono di voler svolgere. Un buon consulente
dovrebbe guidare il cliente verso
una scelta razionale e consapevole sia
delle opportunità che dei rischi dell’investimento.
Certo è più facile assecondarne
le richieste o addirittura rafforzarne i convincimenti
magnificando i rendimenti passati
dell’investimento di moda (come avvenuto
con le azioni tecnologiche a inizio
millennio o il settore immobiliare e bancario
prima dello scoppio della crisi), ma non è
nell’interesse del cliente. La seconda affermazione
è relativa alla scarsa importanza del costo degli strumenti di risparmio
gestito. Questa tesi, sostenuta
dall’esponente di una delle società che
ha i prodotti tra i più costosi sulmercato,
suona un po’ come la storia dell’oste
che magnifica le qualità del suo vino.
Infatti se il costo sostenuto dai sottoscrittori
dei fondi comuni è gravato,
oltre che dalle commissioni di gestione,
anche da commissioni di performance
esorbitanti applicate in virtù del confronto
con indici del mercato monetario,
ormai prossimi a zero, non si fa propriamente
l’interesse del cliente. La terza
riguarda la regolamentazione e addita
come dannosa la Rdr ossia la nuova
normativa introdotta in Inghilterra
che ha sancito il divieto, da parte di chi
vuoleerogareconsulenzafinanziaria, di
ricevere qualsiasi forma di incentivo dai
gestori dei prodotti collocati. Questa
norma di trasparenza elimina alla radice
il conflitto di interessi tra gli intermediari
che vendono i prodotti e i risparmiatori
che pensano di ricevere un consiglio
disinteressato. La sua applicazione anche
Italia s
India is an emerging ‘mobile’ country. The country has the second-largest mobile phone user in the world with nearly 900 million subscriptions. This white paper presents the key areas of emphasis in the growing mobile for development space in India.
Health Monitoring KIOSK: An effective system for rural health managementijiert bestjournal
In the rural areas of our country,patients went to the public health centers (PHC) for their treatmen t. PHCs in India are allotted with hardly one doctor. It is really difficult at a single doctor�s end to provi de treatment to huge number of patients approaching a single doc tor. Therefore,in this work it is proposed to deve lop an automated diagnosis system by developing a Health K IOSK. The health KIOSK shall monitor and measure differen t physiological parameters of the body like heart r ate,blood pressure,body- temperature,SpO2. The KIOSK comprises of signal conditioning & data acquisition systems. The parameters recorded by the KIOSK are s tored in a database and can also be provided in pri nted output form. The patient can therefore approach the doctor with a printed data sheet about his/ her physiological parameters and also with a suggestive prescription for necessary consultation. This approach shall save the time of the doctor and the treatment process can be implemented effective ly.
Arduino based heartbeat monitoring system.Arkadeep Dey
Technological innovations in the field of disease prevention and maintenance of patient health have enabled the evolution of fields such as monitoring systems. Heart rate is a very vital health parameter that is directly related to the soundness of the human cardiovascular system. Heart rate is the number of times the heart beats per minute, reflects different physiological conditions such as biological workload, stress at work and concentration on tasks, drowsiness and the active state of the autonomic nervous system. It can be measured either by the ECG waveform or by sensing the pulse - the rhythmic expansion and contraction of an artery as blood is forced through it by the regular contractions of the heart. The pulse can be felt from those areas where the artery is close to the skin. This paper describes a technique of measuring the heart rate through a fingertip and Arduino. It is based on the principal of photophelthysmography (PPG) which is non-invasive method of measuring the variation in blood volume in tissue using a light source and detector. While the heart is beating, it is actually pumping blood throughout the body, and that makes the blood volume inside the finger artery to change too. This fluctuation of blood can be detected through an optical sensing mechanism placed around the fingertip. The signal can be amplified and is sent to Arduino with the help of serial port communication. With the help of processing software heart rate monitoring and counting is performed. The sensor unit consists of an infrared light-emitting-diode (IR LED) and a photo diode. The IR LED transmits an infrared light into the fingertip, a part of which is reflected back from the blood inside the finger arteries. The photo diode senses the portion of the light that is reflected back. The intensity of reflected light depends upon the blood volume inside the fingertip. So, every time the heart beats the amount of reflected infrared light changes, which can be detected by the photo diode. With a high gain amplifier, this little alteration in the amplitude of the reflected light can be converted into a pulse.
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The sensor housed on the patient’s finger, detects the pumping of the heart and produces a voltage output. This is then transferred to the Microcontroller.
In the Microcontroller the output is plotted with respect to real time to the heart beat rate.
This information can be stored on the computer and can be used to analyze a status of the patient.
IOT BASED NON-INVASIVE BLOOD GLUCOSE LEVEL DETECTION.pptxaseelahkhazi13
Developed and implemented a cutting-edge project aimed at tracking temperature, humidity levels, and toxic gases in the incubator, monitoring the infant's heart rate, and issuing instant alerts for any abnormalities observed.
Real Time Health Monitoring System: A Reviewijtsrd
Generally in critical case patients are supposed to be monitored continuously for their heart rate, oxygen saturation level, blood pressure, body temperature, pulse-oximetry (SPO2) and ECG etc. In the previous methods, the doctors need to be present physically on sight, so that the real time health monitoring system is used every field such as hospital, home care unit, sports using wireless sensor network. This health monitoring system use for chronicle diseases patients who have daily check-up. So, researchers design a system as portable device. Researcher designed different health monitoring system based on requirement. Different platform like Microcontroller, ASIC, PIC microcontroller and embedded systems are used to design the system based on this performance and in the recent years cloud based e-healthcare systems have emerged. In future FPGA based or using IoT we can develop a system which will help to monitor different health parameters. Ajinkya Anant Bandegiri | Pradip Chandrakant Bhaskar"Real Time Health Monitoring System: A Review" Published in International Journal of Trend in Scientific Research and Development (ijtsrd), ISSN: 2456-6470, Volume-2 | Issue-1 , December 2017, URL: http://www.ijtsrd.com/papers/ijtsrd7092.pdf http://www.ijtsrd.com/engineering/electronics-and-communication-engineering/7092/real-time-health-monitoring-system-a-review/ajinkya-anant-bandegiri
An Efficient Design and FPGA Implementation of JPEG Encoder using Verilog HDLijsrd.com
Image compression is the reduction or elimination of redundancy in data representation in order to achieve reduction in storage and communication cost. For this we use the simple computational method, 2D-DCT, using two 1D-DCT performed on matrix of (8X8). The DCT is a technique that converts a signal from spatial domain to frequency domain. Here we first convert the image into minimum code units. Then 2-D DCT is applied on each block. Then further process of Quantization, Zig-Zag approach and encoding is applied on the processed data. The architecture uses 3049 slices, 2,457 LUT, 46 I/Os of Xilinx Spartan-3 XC3S1600.
An Implementation of Embedded System in Patient Monitoring Systemijsrd.com
This paper deals with the measuring of multi-parameter to measure ECG, temperature, evoked potential, respiration rate which uses sensors to measure the patient condition continuously in ICU. For each parameter it uses separate sensors .this multi-channel parameter uses special type of sensors called infracted rays (IR) which are not harmful to human body. All this signals are collected from the patient's body then it is send to the computer and it is diagnosed by the doctor .It reduces the work for the doctors and it gives accurate values. If any abnormalities in the patient's body it produces alarm and it alerts the doctors. This paper also deals with online videography i.e the doctors can view the patient's condition anywhere from the hospital's. Results are stored in the secondary storage system in computer for future reference. the results are obtained in the form of graph, waveforms.
2. Product Classification & Code
Class II medical device
Regulation 21 CFR 870.2770
Impedance plethysmograph
Device used to estimate peripheral blood flow by
measuring electrical impedance changes in a region
of the body such as the arms and legs.
Product code DSB
FDA Review Branch: Division of Cardiovascular Devices
Eligible for third party review
2
4. General Description
Cardiovascular Monitoring System consists of:
Multipurpose Smart Technology finger monitor
Base monitor
Wireless data transmission
Physician programmer
Compatible with Microsoft Excel
4
5. Intended Use
The Cardiovascular Monitoring System is indicated
for use for adults for in-home monitoring of
cardiovascular vital signs during exercise, during
rehab, after prescribed medication, and/or lifestyle
changes under the supervision of a licensed
healthcare practitioner. The device monitors and
displays systolic and diastolic blood pressure, heart
rate, and arterial blood oxygen saturation.
5
6. Principle of Operation
Non-invasively measures:
Blood pressure – systolic and diastolic
Blood arterial oxygen saturation (SPO2)
Heart rate
Data is transmitted wirelessly from the finger unit and
measurements are displayed on the base monitor
Remote programming by physician
Patient can transmit data to physician via internet
Display patient data using Microsoft Excel
6
7. Principle of Operation: Non-Invasive
Blood Pressure
Cardiovascular Monitoring System uses the Oscillometric
method to measure the blood pressure.
The Oscillometric method senses the vibrating signal via
the closed air pipe system and utilizes the microcomputer
to automatically sense the characteristics of the pulse
signal.
The use of a stethoscope is not needed to monitor the
Korotkov sound when deciding the systolic or diastolic
pressure.
7
8. Principle of Operation: Non-Invasive
Blood Pressure
Through a simple calculation, the reading can reflect
the accurate real blood pressure.
The Systolic pressure is defined as the pressure
when the cuff pressure oscillating amplitude begins to
increase.
Diastolic pressure is the pressure when the cuff
pressure oscillating amplitude stops decreasing
8
9. Principle of Operation: Pulse Oximetry
Arterial oxygen saturation is measured by passing
light of two different wavelengths through the patients
finger to a photo detector.
The changing absorbance at each of the
wavelengths is measured, allowing determination of
the absorbance due to the pulsing arterial blood.
9
10. Principle of Operation: Heart Rate
Heart rate is measured with electrical signal
detection technology and is displayed as a digital
read out.
10
11. Principle of Operation Cont.
The system includes wireless technology to transmit
data from the patient sensor to the base monitor for
storage, analysis and display.
Physician can download patient data and display
results graphically or in tabular form using Microsoft
Excel
The data can be uploaded for remote monitoring by
a healthcare professional
11
12. Principle of Operation
Physician programmer establishes individual exercise
goals for blood pressure, arterial blood saturation, and
heart rate for cardiovascular patients:
during rehabilitation
after prescribed medications
lifestyle changes
12
13. Principle of Operation
The patient can send the data to the base monitor at
prescribed times as directed by the physician or the
physician can upload the data remotely for
monitoring/ interpretation of the data through the use
of wireless technology
Physician programmer will determine how downloaded
data will be displayed using Microsoft Office Excel, either
graphically, in tabular format or both
13
14. Substantial Equivalence
Three predicate devices
The Cardiovascular Monitoring System Finger Blood
Pressure Monitor, MDMouse (K081924)
MD300C1 Fingertip Pulse Oximeter (K093757)
Lifegard ICG Monitor (K041434)
Comparison table used to compare CMS to the
predicate devices
14
15. Substantial Equivalence
Comparison Table
15
Feature/Characteristic Cardiovascular
Monitoring System
MDMouse Finger Blood
Pressure Monitor
Fingertip Pulse
Oximeter
Lifegard ICG Monitor
Product Code DSB DXN DQA DSB
Intended Use In-home monitoring of
cardiovascular vital
signs in adult males and
females during exercise,
during rehab, after
prescribed medications,
and/or life-style
changes under the
supervision of a
licensed healthcare
practitioner.
Noninvasive blood
pressure measurement
system intended to
measure the systolic
and diastolic blood
pressures and pulse
rate of an adult
individual.
Portable non-invasive,
spot-check, oxygen-
saturation of arterial
hemoglobin (SpO2)
and pulse rate of
adult and pediatric
patient at home, and
hospital.
Monitor cardiac output
through the use of
Impedance
Cardiography (ICG) in
adult males and
females on adult and
pediatric patients in
hospital areas and
hospital-type facilities,
such as clinics.
Location of Use Home Home Home or hospital Hospital or clinic
Prescription/over the
counter
Prescription Over the counter Prescription Prescription
Device Design Finger unit, silicon
lining, inflatable,
wireless base monitor
Inflatable finger cuff,
silicon lining
Finger unit, silicon lining NIBP cuff, single lead
ECG, base monitor
16. Substantial Equivalence
Comparison Table
16
Feature/Characteristic Cardiovascular
Monitoring System
MDMouse Finger Blood
Pressure Monitor
Fingertip Pulse
Oximeter
Lifegard ICG Monitor
Indications for Use Non-invasively measure
systolic and diastolic
blood pressure, heart
rate, duration of
achieved maximum
heart rate, and arterial
blood oxygen saturation
in adults
Non-invasively measure
systolic and diastolic
blood pressure
Non-invasively measure
arterial blood oxygen
saturation
Non-invasively measure
ECG, heart rate, blood
pressure (NIBP),
functional arterial
oxygen saturation
(SpO2) respiration rate,
temperature and carbon
dioxide (CO2) on adult
and pediatric patients
Sterile/Non-sterile Non-sterile Non-sterile Non-sterile Non-sterile
Patient Contacting
Materials
Silicone
HDPE plastic
Silicone HDPE plastic N/A
Biocompatibility Testing ISO 10993-1 ISO 10993-1 ISO 10993-1 N/A
Inflation Mechanism Pneumatic Pneumatic N/A N/A
Blood Pressure
Measurement
Systolic and diastolic via
oscillometric method
Systolic and diastolic via
oscillometric method
N/A Systolic and diastolic via
oscillometric method
Systolic Blood Pressure
Measurement Range
90-200 mm Hg, 5 mm Hg
increments
60-240 mm Hg, 5 mm Hg
increments
N/A 60-240 mm Hg, 5 mm Hg
increments
Diastolic Blood Pressure
Measurement Range
50-140 mm Hg, 5 mm Hg
increments
40-180 mm Hg, 5 mm Hg
increments
N/A 40-180 mm Hg, 5 mm Hg
increments
17. Substantial Equivalence
Comparison Table
Feature/Characteristic Cardiovascular
Monitoring System
MDMouse Finger Blood
Pressure Monitor
Fingertip Pulse
Oximeter
Lifegard ICG Monitor
Pulse Oximetry
Measurement
Mechanism
Dual light source and
photo detector sensor
N/A Dual light source and
photo detector sensor
N/A
Pulse Oximetry
Measurement
The ratio of light
absorbed at systole and
diastole
N/A The ratio of light
absorbed at systole and
diastole
N/A
Arterial Oxygen
Saturation Measurement
Range
80-100%, in 2.5%
increments
N/A 80-100%, in 1%
increments
N/A
Heart Rate
Measurement
Mechanism
Dual light source and
photo detector
N/A Dual light source and
photo detector
N/A
Heart Rate
Measurement Range
60-180 beats/minute, 5
beats/minimum
increment
N/A 30-254 beats/minute, 1
beat/minimum
increment
30-250 beats/minute, 5
beats/minimum increment
Data transmission Wireless USB cable N/A USB cable
Cleaning Surface cleaning of
finger unit with IPA, as
necessary
N/A Surface cleaning as
needed
Surface cleaning with IPA
as necessary
17
18. Substantial Equivalence
Comparison Table
Feature/Characteristic Cardiovascular
Monitoring System
MDMouse Finger Blood
Pressure Monitor
Fingertip Pulse
Oximeter
Lifegard ICG Monitor
Base monitor Features On/off, keypad, display,
activate display button,
display menu
N/A N/A On/off, keypad, display,
alarm controls, graphical
and tabular data display
Monitor data storage Up to 90 days N/A N/A Up to 72 hours
Finger unit monitor
features
Digital read out display
of
N/A Digital read out display N/A
Software programs Physician programs,
calculation and read-
out, Microsoft Excel
compatible; EHR
compatible
Physician programs,
calculation, digital read-
out; EHR compatible
Calculation, digital read-
out
Physician (or other
programmer) programs,
calculation, read-out
Power type (1) 9.0 V battery USB connection to PC 2 AAA alkaline or
rechargeable batteries
AC or Internal sealed
lead-acid batteries
18
19. Substantial Equivalence Discussion
The CMS has the same intended use as the
predicate devices.
The CMS is substantially equivalent to the predicate
devices in terms of:
Design
Operation
Measurement methods and accuracy
19
20. Substantial Equivalence
No questions arise from the design, materials, or
technological characteristics that would affect the safety
and effectiveness of the device.
Performance test results show that the Cardiovascular
Monitoring System produces measurements as accurate
as predicates.
20
21. Differences
21
Feature/Characteristic Cardiovascular
Monitoring System
MDMouse Finger Blood
Pressure Monitor
Fingertip Pulse
Oximeter
Lifegard ICG Monitor
Location of Use Home Home Home or hospital Hospital or clinic
Prescription/over the
counter
Prescription Over the counter Prescription Prescription
Data transmission Wireless USB cable N/A USB cable
Monitor data storage Up to 90 days N/A N/A Up to 72 hours
Software programs Physician programs,
calculation and read-
out, Microsoft Excel
compatible; EHR
compatible
Physician programs,
calculation, digital read-
out; EHR compatible
Calculation, digital read-
out
Physician (or other
programmer) programs,
calculation, read-out
22. Differences
Prescription vs. over-the counter
Because the Cardiovascular Monitor has features that
require it be used under physician supervision, it is
appropriately only for prescription use.
In-home use
Prescription use only
Adequate IFU
Programming and monitoring by healthcare practitioner
22
23. Differences
Wireless data transmission from Multipurpose
Smart Technology finger monitor to base monitor
Uses radio waves
Technology similar to wireless internet and cellular
phones
Validated during device validation
Data storage in base monitor
Same technology as predicate, but the hardware
contains 20x data storage capacity
Validated during device validation
23
24. Differences
Use of Microsoft Excel to export and analyze
patient data
Well-known software from Microsoft
Guidance document: Guidance for Industry, FDA
Reviewers and Compliance on Off-The-Shelf Software
Use in Medical Devices
Validated for use with CMS
24
25. Summary of required standards
AAMI/ANSI/IEC 60601-2-27:2011 Medical
electrical equipment - Part 2-27: Particular
requirements for the basic safety and essential
performance of electrocardiographic monitoring
equipment
To compare the performance characteristics of different
products: in this case the base monitor which is
recording the continues monitoring of the cardiovascular
vital signs
AAMI/ANSI EC13:2002/(R) 2007 Cardiac monitors, heart
rate meters, and alarms
25
26. Summary of Required Standards
AAMI/ANSI EC57:1998/(R) 2008 Testing and
reporting performance results of cardiac rhythm
and ST-segment measurement algorithm
Heart rate variability for CMS
ISO 9919:2005: Medical electrical equipment -
Particular requirements for the basic safety and
essential performance of pulse oximeter equipment
for medical use
26
27. Summary of Required Standards
ISO 80601-2-61 First edition 2011-04-01 Medical
electrical equipment - Part 2-61: Particular
requirements for basic safety and essential
performance of pulse oximeter equipment
IEC 60601-1
the safety and effectiveness of medical electrical
equipment
IEC 60601-1-2
ISO 10993
27
28. Summary of applicable guidance
documents
Guidance for Industry and FDA Staff: Format for
Traditional and Abbreviated 510(k)s August 12,
2005
Refuse to Accept Policy for 510(k)s: Guidance for
Industry and Food and Drug Administration Staff
December 31, 2012
Guidance for the Content of Premarket
Submissions for Software Contained in Medical
Devices May 11, 2005
28
29. Summary of applicable guidance
documents
Device Labeling Guidance #G91-1 (blue book
memo) March 8, 1991
Draft Guidance for Industry and FDA Staff - Pulse
Oximeters - Premarket Notification Submissions
[510(k)s]
General Guidance Document: Non-Invasive Pulse
Oximeter
29
30. Bench Testing
Bench testing was performed on the device to
demonstrate the effectiveness and accuracy of
measurements.
A hand held pulse oximetery analyzer
manufactured by Fluke Biomedical called the
ProSim 8 Vital Signs Patient Simulator used to
compare the system’s pulse oximeter SPO2
readings with the simulator set points.
30
31. Bench Testing
Verification testing to verify accuracy of the systolic and
diastolic blood pressure measurements of the
Cardiovascular Monitoring System, measured in units of
mm Hg, and compare it side-by-side to the MDMouse
finger blood pressure monitor.
Compare the system’s pulse oximeter SPO2 readings
with the simulator set points and confirm accuracy of
measurement.
Heart Rate test
The study was conducted using patients during pre-
operative period with goal of capturing the heart rate in
the three different phases of preoperative,
intraoperative and postoperative.
31
32. Bench Testing Results:
32
The results of the Cardiovascular Conditioning Monitor
System testing shows that it meets all criteria for safety
and effectiveness as required by the FDA.
The Cardiovascular Monitoring System finger monitor
was tested at all data points for systolic and diastolic
pressure.
All measurements had passing results for systolic and
diastolic pressure measurements for the Cardiovascular
Monitoring System.
Both the Cardiovascular Conditioning Monitor and the
Finger pulse oximeter averaged the same when it come to
the heart beat measurements
34. Standards and Guidance documents
used for Bench testing
IEC 80601-2-30 Edition 1.0 2009-1 Medical
electrical equipment - Part 2-30: Particular
requirements for the basic safety and essential
performance of automated non-invasive
sphygmomanometers
ISO 80601-2-61 First edition 2011-04-01 Medical
electrical equipment - Part 2-61: Particular
requirements for basic safety and essential
performance of pulse oximeter equipment
34
35. Standards and Guidance documents
used for Bench Testing
AAMI/ANSI SP10 Non-automated
Sphygmomanometer (Blood Pressure Cuff)
Guidance Version
AAMI/ANSI/IEC 80601-2-30:2009 Medical
electrical equipment - Part 2-30: Particular
requirements for the basic safety and essential
performance of automated noninvasive
sphygmomanometers
35
36. Clinical Testing
Test Protocol written, approved and executed for
Verification of Accuracy of Systolic and Diastolic
Blood Pressure Measurements for the
Cardiovascular Monitoring System.
Clinical testing was performed at the University
of Mississippi Medical center where an IRB -
approved protocol was performed.
36
37. Clinical Testing
The study was to compare the predicate devices –
The MDMouse Finger Blood Pressure Monitor cleared
under K081924,
The Fingertip Pulse Oximeter cleared under K093757
The Lifegard ICG Monitor cleared under K041434 with
the Cardiovascular Monitoring System (CMS).
Verify real-time data to that of the Cardiovascular
Monitoring System (CMS).
37
38. Clinical Testing Results:
• All testing results show that the Cardiovascular Monitoring
System (CMS) is substantially equivalent to the predicate
devices.
38
39. Standards and Guidance documents
used for Clinical testing
ISO 9919:2005: Medical electrical equipment -
Particular requirements for the basic safety and
essential performance of pulse oximeter equipment
for medical use
AAMI/ANSI SP10 Non-automated
Sphygmomanometer (Blood Pressure Cuff)
Guidance Version
ISO 80601-2-61 First edition 2011-04-01 Medical
electrical equipment - Part 2-61: Particular
requirements for basic safety and essential
performance of pulse oximeter equipment
39