Injection Haemostat

HAEMOSTAT works by injecting compressed minisponges into a wound cavity. They expand 10 times their size when they make contact with fluid. This expansion of sponges in the wound cavity creates internal pressure that is higher than arterial pressure.

Haemostat : United States approved Xstart to be used in battlefield 2014, and for civil use 2015 by FDA approval

15 seconds stop blood
Absord 300 milliter blood/pcs
Hemostatic can stay 4h in body
Syringe-like applicator for fast, easy application into deep, narrow wounds
Indicated for treatment of junctional wounds in the groin or axilla and narrow entrance extremity wounds in the arm or leg

The injection hemostat is mainly composed of three parts: injection cylinder, ejector handle and hemostatic expansion sponge.

The hemostat facilitates rapid delivery of a hemostatic sponge to a bleeding wound.
The handle of the ejector handle is pulled out, ready for the expansion sponge to unfold.
Before pushing the handle against the sponge, place the tip of the hemostat into the wound as close to the source of bleeding as possible.
Trained emergency personnel can apply this product as many times as needed at the injured location to completely wrap the wound.
Each injection hemostat contains multiple non-absorbable expansion sponges.
When the sponge comes into contact with blood or liquid to fill the injured mouth, it rapidly expands in volume, providing a physical barrier and pressure that promotes clot formation.
Surgery is needed to repair the wound before the patient can be transported to a medical facility.
These sponges can be used temporarily for up to 4 hours until surgical care is obtained.
All sponges must be removed from the wound by a surgeon.

Injection Haemostat Verification Report

Verification methods

1. Effectiveness test: animal testing and clinical testing according to relevant criteria. By simulating the bleeding situation of the injured crack, the injection hemostatic device is applied to the injured bleeding site to observe the hemostatic effect.

2. Expansion performance test: Measure the expansion rate of the expansion sponge of the injection hemostat under different conditions and evaluate its expansion performance.

3. Biocompatibility test: According to relevant standards, biocompatibility tests such as cytotoxicity and sensitization were conducted on the swelling sponge of the injection hemostat.

4. Safety: bacterial endotoxin detection, heat source, systemic toxicity test

Verification results

Effectiveness test : After applying the swelling sponge of the injection hemostat to the bleeding site, bleeding can be effectively controlled in a short time. It has been proved that the hemostatic effect is remarkable. According to relevant standards, through animal experiments and clinical experiments, this product stopped arteriovenous gushing bleeding within 19.8±3.4s.

Expansion performance: The expansion sponge of the injection hemostat can maintain good expansion performance under different conditions, and the expansion rate meets the relevant standards.

Biocompatibility: Biocompatibility indicators such as cytotoxicity and sensitization of the injection hemostat all meet the requirements of relevant standards, indicating that the product has good biocompatibility.

Safety: Bacterial endotoxin test, heat source, systemic toxicity test, all negative, indicating that the use of safe and reliable

Conclusion

The Injection hemostat device has good hemostatic effect, detumescence performance and biocompatibility, and is safe and reliable in use. Therefore, this product meets the requirements of the national Class II registration standards, suitable for abdominal and chest, armpit, limbs and other deep tissue arteriovenous bleeding emergency.

INJECTION HAEMOSTAT

Injection Haemostat Verification Report

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