Information of Use

The product is sterilized with Co-60 radiation. Each package includes a radiation color change label. The surgeon shall check the product packaging and identification before use.

The products shall be stored in the cool, dry, well ventilated and clean environment with the relative humidity of not more than 80% and without corrosive gas.

Contraindication

  • Active infection focus anywhere in body
  • Scar diathesis
  • Poor wound healing (hypertrophic scarring)
  • Immune system diseases
  • Current pregnancy or nursing
  • Lupus (such as SLE and DLE)
  • Diabetes
  • Cardiopulmonary dysfunction
  • Scleroderma (such as progressive systemic sclerosis)
  • Polyuria that cannot be controlled and other diseases that hinder the tissue healing
  • History of allergy to foreign bodies
  • Anatomic or physiologic defects that can lead to operative complications
  • Other abnormal reactions on immunology, anatomy or physiology
  • Abnormal psychology, inappropriate motivation, lack of necessary understanding on the risks involved with surgery and products
  • Abnormal mental
  • Unwillingness on acceptance of further surgical revisions

Education and consultation to patients

Complications and risks are possible for implantation of artificial material.
Before surgery, surgeons should inform the patients of benefits, potential risks and the relevant countermeasures. The use of the product depends on the objective explanations of the surgeon and the specific performance during the operation, as well as the patient’s physical condition.

Pre-operative examination

Systemic examination: Check the cruor system, heart, kidney and liver to see if there are any problems. If yes, these problems may result in serious bleeding.
Local examination: Focus on checking whether there is any local infection. For those who are allergic to foreign body, implantation is not recommended.

Selection and check of implant

• Surgeons shall choose proper products according to the surgery requirements. Prepare more products of different types and specifications beforehand in the operating room for the surgeons to choose.
• Check the expiration date: Do not use the product beyond the expiration date.
• Check the sterilization label: Do not use the product without a sterilization label or with a yellow sterilization label.
• Check the packaging sealing: Do not use the product with a unfirm or damaged package.
• Take an implant out of the package according to the sterile requirements;
check the compliance of the implant and the product identification; check the integrity of the implant; do not use the implant if it does not match the identification, or if it is with defects such as deformation, dirty color and so on.

Post-operative Care

Avoid any strenuous exercise, collision or excessive pressure to prevent
displacement of an implant.
If find long-term pain, swelling, fever and other infection symptoms at the
operation position, and they have not been subside rapidly after treatment,
the implants should be removed immediately

After Sale Service

 There is a tracing card inside the packaging of each product. Surgeons should timely fill out the card and then return it to the company after use. Surgeons shall immediately contact the company in case of any quality problems, and keep the samples and the relevant documents. The company will treat it as soon as possible.

Product Quality Responsibility

  • All products comply with KEMENKES RI technical requirements and relevant safety standards.
  • Use is restricted to sterile hospital operating rooms by licensed, properly trained plastic surgeons only.
  • Unauthorized use or off-label application is the sole responsibility of the user.
  • Surgeons must verify packaging seal and sterilization label before use.
  • Damaged or compromised products must not be used under any circumstances.
  • Failure to perform pre-use checks transfers full responsibility to the surgeon.
  • These products are not intended as permanent or lifetime implants.
  • Complications may occur before or after surgery and must be anticipated.
  • Surgical results depend on health status, technique, environment, and post-op care.
  • The company is not liable for complications from external or procedural factors.
  • Infections from poor sterile technique are not the company’s responsibility.
  • Products are designed for single use; reuse is strictly prohibited.
  • Reuse-related issues are the sole responsibility of the user.
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