Instructions For Use (Brief Summary) - Chito-Seal Topical Hemostasis Pad (U.S.)

Rx ONLY

DESCRIPTION
Chito-Seal is a soft, sterile, non-woven pad coated with chitosan. The Chito-Seal pad is packaged in a foil pouch and sterilized by gamma radiation.

INDICATIONS
Chito-Seal is indicated for use in the management of bleeding wounds such as vascular access sites and percutaneous catheters or tubes. Chito-Seal promotes the rapid control of bleeding for patients on hemodialysis and patients on anticoagulation therapy.

PRECAUTIONS

• Chito-Seal is intended for use under the direction of a healthcare professional.
  
• Longer compression may be necessary for patients who are hypertensive or obese.
  
• Sterilized by gamma radiation. For one time use only. Do not resterilize. Do not reuse. Store at controlled room temperature, 15°C to 30°C (59°F to 86°F).
  
• No known contraindications.
  

COMPLICATIONS
Complications may include, but are not limited to:

• Bleeding
  
• Hematomas
  
• Pseudoaneurysm
  
• Rash
  
• Swelling

CHITO-SEAL APPLICATION

1. Open Chito-Seal pouch into sterile field.
   
2. Moisten Chito-Seal pad or puncture site with sterile saline (NOTE: A small flash of blood from the tissue tract may be used instead of sterile saline to moisten the pad. Use this method prior to step 6).
   
3. Pad may be placed over sheath hub prior to removal or placed directly over puncture site after sheath is removed.
   
4. Remove sheath following hospital protocol.
   
5. After sheath removal, maintain firm pressure.
   
6. Cover puncture site with moistened Chito-Seal pad, and apply firm pressure.
   
7. Pressure may be released at 2-3 minutes, to check for hemostasis.
   
8. Continue to apply pressure over puncture site until hemostasis is achieved, then slowly release, leaving the Chito-Seal pad in place.
   
9. Place dry gauze over Chito-Seal pad and cover with an appropriate dressing.
   
10. Within 24 hours, soak Chito-Seal pad with water and gently remove.
    

HOW SUPPLIED
The Chito-Seal pads are provided sterile and non-pyrogenic in unopened, undamaged packaging. The product and immediate packaging does not contain latex. The pads are sterilized by gamma radiation. Do not reuse. Do not resterilize. Store at controlled room temperature, 15°C to 30°C (59°F to 86°F).

Chito-Seal Topical Hemostasis Pad
List/REF 12617

10 - Individually Wrapped Pads Per Carton

PRODUCT INFORMATION DISCLOSURE
Abbott Vascular Devices has exercised reasonable care in the manufacture of this device. Abbott Vascular Devices excludes all warranties, whether expressed or implied, by operation of law or otherwise, including but not limited to, any implied warranties of merchantability or fitness, since handling and storage of this device, as well as factors relating to the patient, diagnosis, treatment, surgical procedures, and other matters beyond Abbott Vascular Devices’ control, directly affect this device and the results obtained from its use. Abbott Vascular Devices shall not be liable for any incidental or consequential loss, damage, or expense, directly or indirectly arising from the use of this device. Abbott Vascular Devices neither assumes, nor authorizes any other person to assume for it, any other or additional liability or responsibility in connection with this device.

Printer Friendly