1. The following guidelines were collected by Terumo from hospitals using TR Band™ since the device has been on the market (2003). These guidelines are supplied for illustration and information purposes only and are in no way, shape or form intended or constructedo to replace the “Instruction for Use” which should be consulted every time and to which the guidelines are just an addition. They are not to be interpreted as a medical advice either: the TR Band™ should be applied or removed at the physician’s sole discretion.

2. Guidelines are based on compilation of best practices. TR Band™ Compression Device removal protocols should be consistent with needs of the provider(s) and patient. Air injection volume and compression time may differ according to the patient’s condition, heparin volume, and the size of the puncture site. Check the puncture site frequently and adjust accordingly.

INFLATE the compression balloon, using the TR Band™ inflator, with the lowest appropriate volume of air required to achieve patent hemostasis.

• Nominal air injection volume: 13 ml
• Maximum air injection volume: 18 ml

Confirm that you are injecting through the tube marked with the "air" mark and do not inject air through any other port. After injection, quickly remove the syringe and be sure to control the plunger in order to

avoid air being forced back into the syringe.

REMOVE the sheath and confirm that there is no bleeding from the puncture site. If bleeding is observed, inject more air (not exceeding a total of 18 ml) until it stops.

Note: The goal is for bleeding to cease when the sheath is completely removed.

ACHIEVE PATENT HEMOSTASIS¹

Clip the pulse oximeter on the index finger and observe the waveform. Occlude the ulnar artery.

• Waveform present: patent hemostasis achieved.
• No waveform present: remove air from TR Band™, 1 ml at a time, till the waveform returns. This is evidence of antegrade radial artery flow.

REMOVAL GUIDELINES^1,2

Recommended

• Heparin ≤ 50 units/kg TR Band™ remains in place for 60 minutes
• Heparin > 50 units/kg TR Band™ remains in place for 120 minutes

CHECK the progress of hemostasis and adjust the air pressure of the balloon with the TR Band™ inflator, removing 3-5ml every 10-15 minutes.

Note: to accelerate the removal of the TR Band™, slowly deflate the TR Band™ in one step.

• If bleeding occurs, inject more air to restore hemostasis (not exceeding 18 ml).
• Confirm patent hemostasis again.
• Wait 15-20 minutes, then repeat step 5, until the air is completely removed.

Before removing, CONFIRM that bleeding has stopped.

• Remove the TR Band™ while stabilizing the access site with gentle pressure.
• Apply sterile dressing.