Spektikor’s new ECG-indicator is certified as a medical device

Spektikor Press release 28.7.2014 (pdf)

Oulu-based company Spektikor Ltd has received a medical device certification for new version of disposable ECG-indicator. The company’s quality management system and product functionality was evaluated by SGS. This is not a small effort for the Start-Up company. “The approval process with the new product started almost immediately after previous product launched to the market”, says CEO Kari Kivistö.

In the new version heart beat is indicated with numbers normal heart rate level is indicated with blue light. In additional, the product has improved water resistance, operating temperature range, storage time and resistance against electric interference. “Although first product got a lot of attention and sales, main thing still was customer feedback”, says Kivistö. “Extensive trial users group brought customers into product development. The most important requirements came up spontaneously. We couldn’t have found those alone with engineering “, continues Kivistö.

A device intended for use by healthcare professionals has been ordered already for several hospital districts and Defense Forces. “The product is simple and easy to use. It will be attached to patient’s chest, and a blinking light indicates the patient’s heart rate and the exact pulse rate can be checked from the numerical display. The product saves medical person time when they no longer need to feel the pulse of the patient physically,” says Kivistö.

Oulu University Hospital, Defense Forces, and the Oulu University of Applied Sciences Social and Health Care Unit, as well as Tekes and the Foundation for Finnish Inventions have joined the development of the device. Production of patented product has started in the Oulu Technology Village.

 

Additional information from Spektikor at:

www.spektikor.com

 

Founded in 2010 Spektikor Ltd is focusing on disposable medical device of an electronics company. Its products Spektikor wants to help medical persons to save time for essential care, the control and monitoring to automate devices and solutions.

 

Kari Kivistö

CEO

+358 40 7453167