CE 2460

[Product name]

MPH Absorbable Hemostatic Particles Applicator

[Models]

TQ-1

[Main structure and property]

MPH Absorbable Hemostatic Particles Applicator consists of handle and tube. TQ-1 applicator has a 14 cm tube length. TO-2 applicator has a 38 cm tube length. The applicator is terminally EO sterilized for single use.

[Intended use]

The applicator is intended for use in delivering the MPH Absorbable Hemostatic Particles to bleeding surgical sites for open surgical procedures or endoscopic / laparoscopic surgical procedures.

[Directions for use]

To prevent product contamination prior to application, always follow aseptic techniques. For open surgical procedures:

1. Prior to initiating the procedure, visually inspect the package containing the Applicator for any signs of damage. If damage is visible, do not use the Applicator.

2. Remove the MPH Absorbable Hemostatic Particles from its packaging and twist off its protective cap. Connect the applicator onto the container of the MPH Absorbable Hemostatic Particles. Applicator is now ready for deployment.

3. Position the applicator tip at the site of bleeding, and begin delivering MPH Absorbable Hemostatic Particles by pumping its container.

4. Avoid direct contact between the applicator tip and blood at the surgical site to minimize the potential for clotting the tip during MPH Absorbable Hemostatic Particle application.

5. If the applicator becomes occluded during use, replace it with a new applicator.

For endoscopic / laparoscopic surgical procedures:

1. Setup the trocar prior to use, and carefully remove the applicator from the trocar after use.

2. Maintain direct visualization of the applicator tip at all times in order to minimize the potential for unintended contact with tissue, organs, or blood which may lead to occlusion of the tip.

[Contraindication]

None reported to date.

[Precautions]

1. This applicator is intended for single use only and cannot be resterilized.

2. Do not use if the package is damaged.

3. Avoid the applicator tip contacting with tissue, organs or blood.

4. The used and expired devices should be disposed as medical waste.

5. Please see the instruction for use for MPH Absorbable Hemostatic Particles for complete information.

[Administration]

A liberal amount of MPH Absorbable Hemostatic Particles should be applied to the bleeding site using the MPH Absorbable Hemostatic Particles Applicator (see lNSTRUCTION FOR USE) followed by pressure until hemostasis is achieved. After hemostasis is achieved, excess MPH Absorbable Hemostatic Particles should be removed by irrigation and/or aspiration.

[Storage]

This product should be stored in dry and ventilated environment at room ambient temperature.

[Shelf Life]

It is valid for 24 months.

Issue Date:2020-08-14

8.13.04.111-A4