Product Description
SanketLife is a clinically grade, touch based 12-Lead ECG monitor which can be carried anywhere and can be operated by anyone with minimal or no training. Since it is capable of taking full 12-Lead ECG, it is apt for use by doctors, healthcare professionals, diagnostic services and users and patients equally. Along with ECG, this portable Heart monitor can measure accurate heart rate, heart rate variability, stress and more than a hundred heart diseases.
Market Suggested Retail Price
$125.00
Distributors / Implementing Organizations
This product is distributed by Agatsa Software Pvt. Ltd.
Manufacturing/Building Method
SanketLife is mass-produced in India.
Intellectural Property Type
Patent Protected
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 here.
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
Kumar, S., 2020, “Assessment of diagnostic accuracy of SanketLife e A wireless, pocket-sized ECG biosensor, in comparison to standard 12 lead ECG in the detection of cardiovascular diseases in a tertiary care setting“, Indian Pacing Electrophysiol J., 20(2), pp. 54–59.
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.
Other Information
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