Tensys T-Line TL-200

Device Name:

T-Line

Device Model:

TL-200

Manufacturer:

Tensys Medical Inc. (Suspended), Suite C, 3444 Tripp Court, San Diego, CA 92121, UNITED STATES.

Measuring functions:

Blood pressure

Primary Client Use:

Intended for patient monitoring

Measurement Site:

Radial Artery

Measurement Occurrence:

Continuous measurement

Availability:

Obsolete

Description:

The Tensys T-Line TL-200 is an arterial applanation tonometry based patient monitor. Medaval has not found evidence proving the accuracy of its blood pressure measurement technology. Blood pressure measurements are taken from the radial artery. It is intended for bedside patient monitoring. This device is now obsolete.

Assessment:

There appears to be no peer-reviewed clinical validation information available on the technology used in the Tensys T-Line TL-200 to measure blood pressure.

Recommendations:

	Accuracy Assessment	Recommendation	Basis
BP	Medaval	Not recommended	This device has not been clinically validated.

Relevant Publications:

Saugel B, Fassio F, Hapfelmeier A, Meidert AS, Schmid RM, Huber W. The T-Line TL-200 system for continuous non-invasive blood pressure measurement in medical intensive care unit patients. Intensive Care Med. 2012 Sep;38(9):1471‐1477. Epub: 2012 Jun 29. doi: 10.1007/s00134-012-2617-x. PMID: 22744376 .

Measurements from the Tensys T-Line TL-200 are compared to those from values measured directly from a femoral arterial catheter, though not in a formal validation.