For Urgent and Unexpected Cases FemoStop™ For Urgent and Unexpected Cases

FemoStop For Urgent and Unexpected Cases FemoStop provides caregivers with a safe and reliable hemostasis option – even in challenging, urgent and unexpected cases to manage bleeding or oozing. FemoStop can be used to stop bleeding or oozing from a femoral puncture after: Coronary angiogram/intervention Cerebral angiogram/intervention Peripheral angiogram/intervention Removal of Intra-Aortic Balloon Pump (IABP)

FemoStop For Urgent and Unexpected Cases Managing Bleeding

Example: Managing Bleeding – Steps 1 and 2 FemoStop can be used for coronary, cerebral or peripheral angiogram procedures or after IABP (Intra Aortic Balloon Pump) removal when other hemostatic devices have failed or if there is bleeding from the puncture tract. Find the artery and manually compress. Call for assistance to apply FemoStop. Prepare FemoStop according to the IFU. While manual pressure is maintained, place the center of the dome over the finger tip that is applying pressure.

Example: Managing Bleeding – Steps 3 and 4 Inflate the dome to 60 mmHg and then start to rotate and remove fingers medially. Continue to inflate dome to approximately 20 mmHg above patient’s BP. Note: Do not keep the supra systolic pressure for more than 3 minutes. Remove the fingers in line with the artery and let the dome take over the pressure. Follow hospital compression protocol. Continue as ordinary FemoStop use.* *Warning: Check pedal pulse periodically to confirm whether or not flow remains in the vessels. Inappropriately long compression and/or immobilization may increase the risk for thrombosis or embolization.

FemoStop For Urgent and Unexpected Cases Managing Oozing

Example: Managing Oozing – Steps 1 and 2 If there is consistent oozing from the puncture tract, or a hematoma, use FemoStop to manage the situation. Prepare FemoStop according to the IFU. With the dome positioned on the arteriotomy, inflate the dome to approximately 30 mmHg or until the oozing has stopped. Maintain low pressure as required. As a recommended time/compression frame, refer to the final part of the Compression Time Example in the How to Use folder.* * The length of compression depends on factors which vary, such as sheath size and anticoagulation status.

Compression Time Example FemoStop For Urgent and Unexpected Cases Compression Time Example

Compression Time Example* * Found in the FemoStop Instructions for Use. ** After max three minutes: lower to mean arterial pressure. Check pedal pulse. *** The length of compression depends on factors which vary, such as sheath size and anticoagulation status.

Rx Only Please review the Instructions for Use prior to using these devices for a complete listing of indications, contraindications, warnings, precautions, potential adverse events and directions for use. Product referenced is approved for CE Mark. FemoStop is designed, developed and manufactured by St. Jude Medical Systems AB. FemoStop, RADI, ST. JUDE MEDICAL, the nine-squares symbol and MORE CONTROL. LESS RISK. are registered and unregistered trademarks and service marks of St. Jude Medical, Inc. and its related companies. ©2011 St. Jude Medical, Inc. All rights reserved. IPN 1678-11