SanketLife

Target SDGs

Market Suggested Retail Price

$125.00

Market Suggested Retail Price (Secondary Currency)

49.00

Target Users (Target Impact Group)

Small and Medium-sized Enterprises, Public Sector Agencies, NGOs

Distributors / Implementing Organizations

This product is distributed by Agatsa Software Pvt. Ltd.

Competitive Landscape

Direct competitors include Spandan ECG and Cardio-Pad.

Manufacturing/Building Method

SanketLife is mass-produced in India.

Intellectural Property Type

Patent

User Provision Model

This product can be bought directly from manufacturer.

Distributions to Date Status

Unknown

Design Specifications

SanketLife is intended to be a portable wireless device, able to provide ECG reports. Aiming to that, it is light (~45 g) and small (96 x 50 x 22 mm), using Bluetooth connectivity to send the patterns taken through  a 12 lead ECG to an Android or iOS app. In has In-App interpretations of the results, which are supported by AI-driven technology. It also works with a Li-Ion coin battery with a capacity of 600 mAh. Detailed specifications can be found the website.

Product Schematics

Technical Support

Provided by the manufacturer.

Replacement Components

Provided by the manufacturer.

Lifecycle

2-year free-replacement warranty.

Manufacturer Specified Performance Parameters

Diagnostic accuracy variables such as sensitivity, specificity, negative and positive predictive value, negative and positive likelihood ratios needed to be estimated.

Vetted Performance Status

A prospective diagnostic test accuracy trial was  conducted in outpatient settings of a tertiary cardiac care centre in India. A total of 100 patients, attended cardiology OPD, were included in the study. Consecutive ECGs were taken by 12 lead standard ECG as well as by SanketLife ECG.

Safety

Since Sanketlife is a monitoring device, qualifies as a Class II medical device, with risks associated with its precision to provide accurate measurements. This device complies with the ISO 13485:2016, and Agatsa is working with different agencies for US FDA clearances and CE validations because of the high demand for small ECG machines in the international markets.

Complementary Technical Systems

SanketLife Mobile App

Academic Research and References

Compliance with regulations

 ISO 13485:2016, USFDA 510(K) in process, ETSI EN 300 328 V1.91:2015, CE, EC13. IEC 61000-4-2:2008,IEC 61000-4-3:2007. 

Evaluation methods

A prospective diagnostic accuracy trial was conducted in a tertiary care setting, a total of 100 patients underwent for both type of ECG (a standard 12 lead ECG as well as SanketLife) consecutively. The primary objective of the study was to ascertain the diagnostic accuracy and reliability of the SanketLife ECG in comparison to standard 12 lead ECG.  The patients either came to the cardiac tertiary care centre with symptoms suggestive of cardiovascular disease or have a history of it. All patients who were referred for 12 lead standard ECG, also got their consecutive ECG done with SanketLife. ECG variables namely Heart Rate, PR, QRSD, QT & QTc were monitored, displayed and saved in a cloud system and compared against certain heart abnormalities visual against traditional 12 LEAD ECG machine.   The analysis showed a high degree of agreement and accuracy of SanketLife in detecting major cardiovascular conditions (Major Minnesota codes) such as Left and right bundle branch block, ST-segment elevation and ST-segment depression, AV conduction block. SanketLife showed high sensitivity (98.15%) and specificity (100%) in diagnosing major cardiovascular conditions.

Other Information

Sanketlife User Manual