SAFETY INFORMATION

Reporting Serious Incidents

If you experience a serious incident while using this device, or if you become aware of a serious incident involving this device, please report it to us immediately. A serious incident is any malfunction or deterioration in the performance of the device that has led to, or could lead to:

The death of a patient, user, or other person.
A serious deterioration in a person’s state of health.
An immediate public health threat.

You can report a serious incident by:

Email: Send an email to info@sentinelmedtech.com
Phone: Call us at + 1-800-579-4910
Website: Visit our website www.sentinelmedtech.com and navigate to the “Reporting Incidents” section.

Reporting timelines should be included for the reporting section:

For incidents posing an immediate public health threat, report within 2 days.
For incidents leading to death or serious deterioration, report within 10 days.
For all other serious incidents, report within 15 days.

CONTACT INFORMATION

Sentinel Medical

50 N Laura St,

Ste. 2500

Jacksonville, Fl 32202

Phone: 1-800-579-4910

www.sentinelmedtech.com

BE | REP

OBELIS S.A.

Bd. Général Wahis,

53 1030 Brussels, Belgium

Tel: +32.2.732.59.54

Fax: +32.2.732.60.03

E-mail: mail@obelis.net www.obelis.net

Physician Testimonials

Patrick Beer, DO, Critical Care Surgery Specialist, Hurley Medical Center

“I would recommend TraumaGuard to my colleagues – having watched it correlate 1:1 in the OR with insufflation pressures, as well as looking at the ease of use – this is a very valuable technology to use going forward, especially in resuscitation of patients in the ICU.”

Leo Mercer, MD, Critical Care Surgery Specialist, Hurley Medical Center

“Accuracy is difficult to assess – I can tell you that the best reference number I have for Intra-abdominal Pressure is coming off an insufflator, and to the extent that the TraumaGuard catheter is correlating - almost 1:1 - with that number, is comforting. It really can’t get better than that, frankly.”