FAQ (Transradial Intervention)

No, the plastic jacketed wire in the Introducer Kit does not have hydrophilic coating in order to avoid the risk of the guidewire slipping and falling into the blood vessel.

GSS is made from a soft ETFE material, which allows the sheath to revert back to the original position after kinking. Therefore sheath kinking does not impair device insertion. Due to the nature of the material, there is low risk of damage to the vessel wall even if the sheath has been kinked.

No, GSS is limited to use in TRI. This is also written in the IFU. Please use RADIFOCUS™ Introducer ll for TFI.

We recommend physicians to use GSS when the radial artery size is larger than the outer diameter (O.D.) of the sheath. The O.D. for each Fr size is as follows:
5Fr GSS: 2.29 mm
6Fr GSS: 2.62 mm
7Fr GSS: 2.95 mm

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The whole length. / From the distal to the proximal tip.

Due to the use of tungsten (radiopaque material).

Core: Nickel-titanium alloy / Nitinol
Coating: polyurethane with tungsten and hydrophilic polymer

The following types are available: Straight, Angled, 6.0 mm J shape, 1.5 mm J shape, 2.0 mm J shape, 3.0 mm J shape, Double angulation (Bolia curve)

The following types are available: Standard, Half stiff, Stiff

Lengths from 80 cm to 450 cm are available.

The following types are available: 0.018", 0.025", 0.032", 0.035", 0.038"

After injection, quickly remove the syringe. Please make sure to keep the plunger in place with your thumb.
→If the plunger is not kept in place, the air may be forced back into the syringe and the balloon pressure may decrease.
→If the syringe is removed slowly, it may cause air leakage and the balloon pressure may decrease.

PRECAUTIONS

・Do not use the TR Band™ Inflator for other purposes than to inflate the TR Band™. It is not designed for other purposes.
・The TR Band™ can be inflated only by using the TR Band™ inflator included in the kit or the TR Band™ Air Volume Regulator. If other devices are used, adequate air compression can not be achieved.
・Depending on the patient’s condition and the degree of balloon pressure, an adverse event including artery occlusion, hypodermic hematoma, hemorrhage, pain, or numbness may occur. Check the progress of the hemostasis and adjust the air pressure accordingly.
・When connecting the TR Band™ inflator included in the kit or TR Band™ Air Volume Regulator to the TR Band™, keep the plunger in place. Releasing the plunger will cause the air to expel from theTR Band™. Loss of air compression may cause bleeding.
・Bleeding could occur if the adjustable fastener comes off during compression. Depending on the patient’s wrist size and the way the device is applied, the adjustable fastener could come off. Fix the adjustable fastener in place with tape if necessary.
・This device has been sterilized by ethylene oxide and is for single use only. Do not resterilize or reuse.
・Do not use this device if the unit package or the product has been damaged or soiled.
・The device should be used immediately after the package and of safely and properly after use.
・Avoid exposure to water, direct sunlight, extreme temperature, or high humidity during storage.

The maximum acceptable injection volume is 18 ml. If this volume is exceeded, it will be painful for patients. It will also cause damage to the pressure confirmation balloon.

Referring to the protocol of a hospital in Japan which uses TR Band™, the standard time is 4 hours. However, the compression time may differ according to the patient's condition and the hospital condition. Please check the puncture site and adjust accordingly.

In the event that the patient complains of pain: confirm there is no bleeding and remove an appropriate volume of air.

In the event that the puncture site is bleeding:
Inject more air until the bleeding stops. (Maximum acceptable air volume is 18 ml in total.)

Recently, there has been a trend of minimizing the compression pressure and compression duration in order to decrease the RAO risks. Various factors such as the patient's blood pressure, anticoagulation and heparin administration affect the hemostasis condition so please manage this carefully while confirming that there is no bleeding.

PRECAUTIONS

• Do not use the TR Band™ Inflator for other purposes than to inflate the TR Band™. It is not designed for other purposes.
• The TR Band™ can be inflated only by using the TR Band™ inflator included in the kit or the TR Band™ Air Volume Regulator. If other devices are used, adequate air compression can not be achieved.
• Depending on the patient’s condition and the degree of balloon pressure, an adverse event including artery occlusion, hypodermic hematoma, hemorrhage, pain, or numbness may occur. Check the progress of the hemostasis and adjust the air pressure accordingly.
• When connecting the TR Band™ inflator included in the kit or TR Band™ Air Volume Regulator to the TR Band™, keep the plunger in place. Releasing the plunger will cause the air to expel from theTR Band™. Loss of air compression may cause bleeding.
• Bleeding could occur if the adjustable fastener comes off during compression. Depending on the patient’s wrist size and the way the device is applied, the adjustable fastener could come off. Fix the adjustable fastener in place with tape if necessary.
• This device has been sterilized by ethylene oxide and is for single use only. Do not resterilize or reuse.
• Do not use this device if the unit package or the product has been damaged or soiled.
• The device should be used immediately after the package and of safely and properly after use.
• Avoid exposure to water, direct sunlight, extreme temperature, or high humidity during storage.

Please refer to the chart below.

No, this device is sterilized. By direct application, you can confirm the situation of hemostasis easily through the transparent material.

By adjusting the band to the patient's wrist size, it is possible to compress at almost the same pressure for all patients.

Fix the belt on the wrist with a little space on the ulnar artery side. This may help you to ensure enough space after air injection into the compression balloon. The space on the ulnar artery side can help avoid compression of nerves and the ulnar artery, etc. and thus, it can decrease pain.

→Caution: if the band is fixed too loosely, the compression balloon may slip out from the access site or adequate pressure for hemostasis may not be achieved.
→"Putting a 2.5 mL syringe inside the band on the ulnar artery side" is an example of an easier method to fix the TR Band™ on the wrist.

TR Band stands for Terumo Radial Band.

Regular size is for 14-20 cm wrist size patients and large size is for 14-25 cm wrist size patients.

*If you have to apply the band to patients who have thinner or thicker wrist sizes than those listed above, the length of the magic tape overwrapping part may be too short and there is an increased risk of it coming off. Please consider countermeasures, for example, fixing the adjustable fastener in place with a tape.

Why does TR Band™ have two balloons?

Please align the green marker on the arterial puncture site. Depending on the angle of insertion, there may be a gap between the skin puncture site and arterial puncture site. The compression pressure should be applied to the arterial puncture site.

4Fr PBS: 19 mL/sec, iohexol: 12 mL/sec @750 psi
5Fr PBS: 32 mL/sec, iohexol: 21 mL/sec @ 1000 psi
6Fr PBS: 37 mL/sec, iohexol: 25 mL/sec @ 1000 psi

Difference between Jacky and BLK

Please select according to your preference!

They are all dedicated catheters for transradial procedures

You can choose the right one for you depending on your preference. More details about each one can be found below.

History

TIG I (4.0) design

・First developed in Japan in 1991. (Tora-no-mon shape: Tora means Tiger in Japanese)
・The shape combines the concepts of JL and JR, and is designed to be able to access both the LCA and the RCA from the right radial artery.
・The secondary curve (↘) is for ensuring minimal injury to the aortic wall when rotating and for adjustment of back-up support when maneuvering.

Jacky & Sarah design

・Developed in Japan. (Named after amine/manga cartoon characters)
・Jacky has a less acute primary curve (○) for better coaxial engagement with inferior angled LCA and RCA.
・Angled catheter tip (↗) prevents dislocation when flushing the catheter.

TIG II design

1. The proximal curve(○) is designed to locate the catheter shaft at the center of the ascending aorta to maneuver right or left easily.
2. The primary curve (╰) is wider than TIG I, which is designed for inferior angled LCA and RCA.
3. Due to 1 & 2 above, the back-up force to the LCA is a little weak, which should be overcome through techniques and shapes.

Variety of TIG Ⅱ

CL/CR have more round curves.

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SR stands for short; short tip AR and short tip AL.

Please contact your local Terumo representative for more details.

Please contact your local Terumo representative for more details.

Please contact your local Terumo representative for more details.

It comes from the name of Dr. Yuji IKARI who devised this shape.

5Fr, 6Fr and 7Fr.　
*Please contact your local Terumo representative for more details.

IL/IR are more curved than JL/JR.

It is 100 cm.

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