RadiStop™ Compression Assist Device Education Module

Module Content Radial Anatomy RadiStop Product Information New Features How To Use

Radial Anatomy Radial Artery Puncture Site Puncture Site Ulnar Artery Sheath Hub

Radial Anatomy - Allen’s Test RadiStop Compression Assist Device is contraindicated in patients who do not have two functional arteries (ulnar and radial). RadiStop should not be used on patients having an abnormal Allen’s test. Example of Allen’s test being performed to confirm presence of ulnar and radial aterial flow.

RadiStop Product Information - Parts Compression Pad The transparent compression pad allows for correct placement and concentrates pressure directly over the puncture site. Straps Two straps secure the support plate in position. Support Plate The improved support plate provides stable, comfortable support of the wrist.

New Features The new, transparent compression pad allows correct placement over the puncture site. The improved support plate enables controlled positioning before, during and after the procedure to enable reliable compression and post hemostasis care. Improved comfort for the patient with a slimmer plate design, and ridges for easing the pressure on the back of the hand. Previous Version (item no 11177) Current Version (item no C11177)

RadiStop - How To Use Place the patient’s (left or right) hand “palm-up”on the support plate. The hand should be in the same direction as the “hand” symbol on the support plate. Place the distal strap over the palm, distal to the thumb, to secure to a comfortable fit. Secure the proximal strap around the patient’s forearm. Do not over tighten the proximal strap as this may cause discomfort.

RadiStop - How To Use (cont.) 3. Center the compression pad directly over the puncture site. Withdraw the introducer sheath just enough to clear the rim of the compression pad. Confirm placement through the transparent pad. Thread the VELCRO® portion of the compression pad strap through the loop on the compression pad rim. 4. Hold the thumb firmly on the compression pad and the fingers securely around the support plate (“C-grip”).Remove the sheath with the other hand. Note: Keep the compression pad level with the skin surface.

RadiStop - How To Use (cont.) 5. Continue to apply manual compression while securing the VELCRO. Adjust the pressure by tightening or loosening the compression pad strap. When hemostasis is achieved, check the radial pulse distal to the compression pad.

RadiStop - How To Use (cont.) 6. Excess portion of the VELCRO strap can be shortened (thread under the compression pad strap) or cut, to prevent the VELCRO from attaching to other fabrics. It is recommended to maintain pressure per hospital protocol (e.g. a total of two (2) hours following a diagnostic procedure and total of four (4) hours following an interventional procedure). Warning: Do not leave the system on for extended compression time as tissue damage may occur. Once hemostasis is achieved, remove the device and provide bandaging of the wound as per hospital protocol. The support plate may be left in place with zero or very low compression pressure on the puncture site.

How To Use - Summary 1. Place patient’s hand and secure the distal strap. 2. Secure the proximal strap. 3. Center the compression pad and thread the VELCRO strap. 4. Remove the sheath while using the “C-grip”. 5. Apply manual compression while adjusting the pressure with the VELCRO strap. 6. Fold the VELCRO strap and maintain pressure per hospital protocol. Warning: Do not leave the system on for extended compression time, as tissue damage may occur.

Application Protocol Apply RadiStop - to achieve hemostasis Diagnostic 2 Hours Compression* Intervention 4 Hours Compression* * Maintain pressure to achieve hemostasis for what would be considered the routine duration required for the specific patient´s anticoagulant level, the interventional procedure performed and the sheath French size used. Once total hemostasis has been established, remove the device. Bandage the wound as per hospital protocol.

RadiStop - Troubleshooting Bleeding Occurs Apply manual compression by holding the thumb on the compression pad and the fingers securely around the support plate while securing the VELCRO. Patient Experiences Pain Apply manual compression by holding the thumb on the compression pad and the fingers securely around the support plate, while adjusting the VELCRO or the straps.

This is the last page of this module 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 RadiStop is designed, developed and manufactured by St. Jude Medical Systems AB. Unless otherwise noted, ™ indicates a registered or unregistered trademark or service mark owned by, or licensed to, St. Jude Medical, Inc. or one of its subsidiaries. RadiStop, 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. ©2010 St. Jude Medical, Inc. All rights reserved. VELCRO® is a trademark of Velcro Industries B.V. IPN 1138-10