Instruction for use
MPH Absorbable Hemostatic Particles Applicator
CE 2460
[Product name]
MPH Absorbable Hemostatic Particles Applicator
[Models]
TQ-4
[Main structure and property]
MPH Absorbable Hemostatic Particles Applicator (TQ-4) consists of Y-junction, catheter, connecting pipe 1, connecting pipe 2 and air filter (0.22μm), and the length of the catheter is 2 m. The applicator is made of medical polymer material, which has good biocompatibility, and is terminally sterilized by EO, the EO residue is less than 10ug/g, and is free from pyrogenicity.
[Intended use]
The Applicator is intended to assist the delivery of MPH Absorbable Hemostatic Particles to the treatment site in endoscopic surgeries.
[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 arteriolewhen 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 requiring adjunctive hemostasis during surgery. However, the product is not recommended for use in children and pregnant women.
[Intended user]
The Applicator is used by health care professionals in clean operating rooms.
[Direction for use]
To prevent product contamination prior to application, always follow aseptic techniques.
For endoscopic surgical procedures which 'spray MPH Absorbable Hemostatic Particles to control bleeding:
1. Prior to initiating the procedure, visually inspect to ensure each connection of the Applicator is well connected by Luer connector.
2. Firmly insert the MPH Absorbable Hemostatic Particles nozzle into the mouth (A) of Y-junction (Fig.1).
3. Connect the connecting pipe 2 to gas source with constant airflow (16±3 kPa) to prevent any fluids from the reverse flowing into the catheter (Fig 2).
4. Insert the catheter through a working channel on the endoscope (Fig.3) and position the endoscope to the bleeding site. Avoid direct contact of the catheter tip with any fluids.
5. Select the gas source to obtain a lower airflow (12±3 kPa). Gently tilt Y-junction to deliver the powder to the site of bleeding via gently pressing MPH bottle (Fig.4). Avoid direct contact of the catheter tip with any fluids. If that unfortunately occurred, the MPH bellows applicator can be removed in a squeezed state which can improve occluded problem.
6. Remove the catheter from the endoscope immediately after hemostasis is achieved.
[Contraindication]
None reported to date. However, the applicator is used with MPH Absorbable Hemostatic Particles, there are still some contraindications to note.
The applicator is only used with the MPH Absorbable Hemostatic Particles, it is not recommended for other products.
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 product 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. Avoid folding the catheter when delivering the MPH Absorbable Hemostatic Particles.
6. TQ-4 Applicator should apply quickly: deflation is required when spraying MPH Absorbable Hemostatic Particles in gastrointestinal tract for over a minute.
7. The used and expired products should be disposed of in compliance with pertinent government regulations regarding medical devices.
8. Please see the instructions for use for MPH Absorbable Hemostatic Particles for complete information on the absorbable hemostat.
9. The Applicator is easy to operate, no need for special training. Users need to fully read the instruction for use before operate to obtain relevant information.
10. 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.
[Storage]
This product should be stored in a dry and ventilated environment at a storage temperature of 2~30 c.
[Shelf Life]
It is valid for 24 months.
8.13.04.0504-A1
Issue date: 2025-06-05
