US

The Redsense device is intended to monitor for potential blood loss from the hemodialysis access site in hemodialysis patients undergoing hemodialysis treatment up to 5 hours at home or in the clinical setting.

The device includes a blood sensor incorporated into an adhesive dressing. The sensor monitors potential blood leakage from the needle puncture via an infrared light and will alarm if needle dislodgement or blood leakage is detected.

All use must be administrated under physicians prescription, and must be observed by a trained and qualified person considered to be competent in the use of this device by the prescribing physician.

Redsense received FDA clearance in October, 2007 for hemodialysis in the clinical setting and in May 2010, for home hemodialysis.

Canada

The Redsense - device is intended to monitor for potential blood loss from the hemodialysis access site in hemodialysis patients undergoing hemodialysis treatment up to 5 or 12 hours (depending on version) at home or in the clinical setting. The device includes a blood sensor incorporated into an adhesive dressing. The sensor monitors potential blood leakage from the needle puncture via an infrared light and will alarm if needle dislodgement or blood leakage is detected. All use must be administrated under physicians prescription, and the patient using the device at home must be considered to be competent in the use of this device by the prescribing physician.

Europe

The Redsense device is an alarm system for monitoring the vein needle during hemodialysis in clinic or at home. Redsense is CE marked and herefore quality approved according to European standards.

Australia

The Redsense alarm Sensor is for monitoring the Venous Needle during Haemodialysis. The Senors monitor needle dislodgement by detecting blood leakage and relaying a signal to the Alarm Unit.