• Product Info

  
  

  • Product Name- TraumaGuard

  • Model number – 000-0221

  • Basic UDI Info- 08600034787000-0221WW

• Indication for use statement

  • Intended Use TraumaGuard Intra-abdominal Pressure-Sensing System is intended for use in the drainage of urine and continuous measuring of intra-abdominal pressure (IAP) and core body temperature (CBT). The measured IAP can be used as an aid in the diagnosis of intra-abdominal hypertension (“IAH”) and abdominal compartment syndrome (“ACS”).

• Contra indication and precaution statement (s)

  • Contra-indications TG should not be used if the patient has a known allergic reaction to silicone or polyurethane.

  • Precautions- Important Catheterization with TG can only be performed by a qualified and trained Healthcare Professional. TG is strictly single-use and must not be re-used. The TG Cable should be cleaned using the methods defined by local Clinical Policies.  LBL-002 rev 13 

 Please Note:

• Only use water-based lubricants or gels.

• Use a Luer Tip syringe to inflate the balloon with sterile water.

• Fill the balloon slowly to the specified capacity. CAUTION: FEDERAL LAW RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A PHYSICIAN Precautions

• Use only under physician directive if any of the following Patient conditions are known to exist: o Known current Urinary Tract Infection (UTI) o Urethral injury and stricture o Recent urethral or bladder surgery o Prior transurethral  resection  of  the  prostate with a large tissue defect o History of abdominoperineal resection for rectal cancer, rectal stenosis, or other major rectal pathology o Significant symptoms of urinary obstruction prior to  treatment

• Do not use ointments or lubricants with a petroleum base.

• Do not use sharp instruments with TG. Sharp instruments could damage the catheter and cause it to malfunction.

• It is recommended that the patient drink more water when catheterized – please follow local Clinical Policies on fluid intake. • Patients with Indwelling Catheters should be monitored in accordance with local and national Clinical Policies.

• Strict adherence to aseptic technique and hand hygiene are essential to minimize the risk of Catheter Associated Urinary Tract Infections.

• Do not stretch the catheter – stretching may damage the catheter.

• Do not modify or attempt to repair the TG cable. If malfunction occurs and is not resolved by following the procedure in step 3, discard and order a replacement unit.

• Sterilization method

   

  • Single use device sterilized by E-beam 

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