BleedArrestER

Technical Information

Intended Use:

Intended Use: BleedArrest® ER Topical Hemostat Sponge is intended for use under the care of a health care professional as a topical dressing for the treatment of mild bleeding from topical ENT surgical wounds and nosebleeds. It is also indicated for control of bleeding from the skin at percutaneous needle access, vascular access and percutaneous catheter access sites.

Contraindications:

BleedArrest® ER Topical Hemostat Sponge should not be used on patients who have known allergies to potato starch. Contains Amylopectin (potato starch) and hydroxyethylcellulose.

Warnings:

•BleedArrest® ER Topical Hemostat Sponge is not intended as a substitute for appropriate standard of care procedures and meticulous surgical techniques.
• The safety and efficacy of BleedArrest® ER Topical Hemostat Sponge in combination with other hemostatic devices has not been clinically evaluated and is therefore not recommended.

Precautions:

•Carefully read the Instructions for use prior to application.
• Single Use Only.
• Sterility not guaranteed if package is damaged or opened. Discard damaged or open packages.
• Expiration Date: This device should not be used after the end of the year and month shown.
• To prevent product contamination prior to application, always follow aseptic techniques.
• Keep dry prior to use.
• Do not injest or inhale
• Clinician must inform the patient that the device contains potato starch.
• BleedArrest® ER is not bacteriostatic toward pre-existing infections, nor does it prevent the occurrence of new infections. Appropriate treatment to be instituted in case of infection.
• This product shall be disposed of in compliance with pertinent government regulations regarding medical devices.

Instructions:

1. Peel open pouch to remove contents.
1. Peel open BleedArrest® ER pouch and remove sponge.
2. Blot excess blood from the wound with gauze.
3. Apply BleedArrest® ER sponge to cover wound.
4. Apply gauze over sponge and hold in place until hemostasis is achieved.
5. If hemostasis has not been achieved, repeat steps 2-4 or use an alternate method of hemostasis treatment.
6. BleedArrest® ER leaves the site of placement by natural elimination or it may be aspirated from the application site at the direction>

Caution: Federal (U.S.) law restricts this device to sale by or on the order of a physician. For detailed information regarding indications for use, warnings and precautions, see Instructions for Use.

Content taken from 50226 Rev.A