Spandan ECG

Distributors / Implementing Organizations

The product is distributed by Sunfox Technologies.

Manufacturing/Building Method

This product is mass-produced in India.

Intellectural Property Type

Open Source

User Provision Model

Spandan can be purchased from the manufacturer's website and from Amazon. The product can also be purchased from manufacturer partners. ^{Interview with designer in 2020}

Distributions to Date Status

Over 10,000 patients have been screened, and over 1,000 customers have been reached. ^{Interview with designer in 2020}

Design Specifications

There are four steps to using Spandan. First, the user must download the Spandan ECG app on their smartphone. Next, the Spandan device is connected to the smartphone via a USB connection. Next, the electrodes are placed on the chest of a person in the locations indicated on the app, and finally, the test is performed and a report is created that can be shared with experts. Spandan weighs 12 grams and has product dimensions of 64 x 40 x 10 mm.

Technical Support

Provided by the manufacturer.

Replacement Components

Electrode pads

Lifecycle

The Spandan device itself is reusable and the electrode pads are reusable up to 2-3 times before needing to be replaced.

Manufacturer Specified Performance Parameters

Manufacturer specified performance targets include: small, easy to use, accurate, low weight.

Vetted Performance Status

The Spandan team has performed several tests specifically looking at the accuracy of the device in detecting cardiac abnormalities. The product has also undergone clinical trials and pre-compliance testing. ^{Interview with designer in 2020}

Safety

Safety information is listed in the product manual:

• Use only the approved leads for the device
• Do not disassemble the unit
• If there are any abnormalities during the measurement, remove the leads or change the electrode pads
• Always consult your doctor
• People with prior heart disorders should consult a doctor before and after using the unit

Complementary Technical Systems

An Android smartphone with version 5 i.e., Lollipop or higher is required.

Academic Research and References

Compliance with regulations

CE certified and CDSCO cleared. The product is in the process of becoming IEC60601 and ICMED13458 certified. ^{Interview with designer in 2020}

Other Information

ASME iShow India 2020 finalist