CE 2460
[Product name]
MPH Absorbable Hemostatic Particles Applicator
[Models]
TQ-2
[Main structure and property]
MPH Absorbable Hemostatic Particles Applicator consists of handle and tube. TQ-1 applicator has a 14 cm tube length. TQ-2 applicator has a 38 cm tube length. The applicator is terminally EO sterilized for single use, the EO residue is less than 10ug/g, and is free from pyrogenicity.
[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.
[Description of MPH Absorbable Hemostatic Particles]
MPH Absorbable Hemostatic Particles is a kind of absorbable hemostat for surgical wound. It is made from potato starch by emulsion cross-linking technology and has good biocompatibility. Applicators are used for the delivery of hemostatic particles, as adjunctive hemostatic device to control bleeding in the capillary, vein, and arteriole when compression, ligation, and other conventional procedures are ineffective or impractical. It is recommended to use the applicator in conjunction with absorbable hemostatic particles manufactured by Singclean, and other absorbable hemostatic particles products need to be verified before use. Please refer to the instructions for use of the MPH Absorbable Hemostatic particles for complete information on the absorbable hemostat.
[Patient target groups]
The product is used in combination with MPH Absorbable Hemostatic Particles for patients requiringadjunctive hemostasis during surgery(except neurological and ophthalmic). However, the product is notrecommended for use in children and pregnant women.
[Intended user]
The Applicator is used by health care professionals in clean operating rooms.
[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 unscrew the screw cap of the spray bottle. Connect the applicator onto the spray bottle 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 spray bottle.
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. However, the applicator is used with MPH Absorbable Hemostatic Particles, there arestill some contraindications to note
1. The applicator is only used with the MPH Absorbable Hemostatic Particles, it is not recommended for other products.
2. The safety and efficacy of the MPH Absorbable Hemostatic Particles has not been clinically evaluated in children and pregnant women. Therefore, the product is not recommended for use in children and pregnant women.
[Precautions]
1. This applicator is intended for single use only, re-use of contaminated products may cause wound infection and inflammation
2. Do not use if the package is damaged.
3. Avoid the applicator tip contacting with tissue, organs or blood
4. The applicator is sterilized by EO and should not be re-sterilized. Otherwise, the user uses a product whose function has failed due to re-sterilization, which may prolong the operation time.
5. The used and expired products should be disposed of in compliance with pertinent government regulations regarding medical devices.
6. Please see the Instructions for use for MPH Absorbable Hemostatic Particles for complete information on the absorbable hemostat.
7. The applicator is easy to operate, no need for special training. Users need to fully read the instruction for use before operation to obtain relevant information.
8. In case of any serious incident related to the device, it shall be reported to the manufacturer, EU authorised representative, notified body and the competent authority of the Member State in which the user and/or patient is established
[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. Please refer to the instructions for use of the MPHAbsorbable Hemostatic particles for complete Information on the absorbable hemostat.
[Storage]
This product should be stored in a dry and ventilated environment at a storage temperature of 2°C-30°C.
[Shelf Life]
It is valid for 24 months.
Issue Date:2025-06-05
8.13.04.0113-A6
