surgical skin closure

surgical skin closure -Instruction for Use  

Surgical skin closure is an auxiliary device to help wound healed better, this device is applied on the skin layer after stitched the incision, and this adjustable device can make skin closure a fast and easy process.

I. Configuration

· as shown, Surgical skin closure is composed of several rotatable screw, two adhesive plaster(1&2) with plastic beam(4), attached a sleeve handle. The screw connect two adhesive plaster together, and use sleeve handle to adjust the breadth.

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II. Capability

1. Holding Power: distance of glide≤2.5mm at 36-38℃

2. peel strength:average force ≥1.0N/cm

3. Water vapor transmission: ≥500g/m2 per 24 hours

4. Pulling force in Parallel direction: after the screw and plastic beam are equipped, the pulling force in the parallel direction is not less than 20N.

5. Aseptic packaging should be intact, no matter, no break or sealed incomplete, no moisture or watermark

6. Peel strength of the seal is between 0.1N/mm~0.5N/mm. The  surface are smooth and continuous, without delamination or tearing

7. Sterilized by Ethylene Oxide.

8. After sterilized, the Ethylene Oxide residual should less than 10μg/g.

III. Specification

IV. Application

Surgical skin closure is applied to straight surgical incisions or similar straight.

V. Usage

1. Before use this device, please make sure incision had been sutured.

2. Keep your skin clean.

3. Specification of surgical skin closure is base on its length. In order to provide auxiliary tension for incision, you can choose suitable specification according to the length of incision, or cut with sterilized scissors to shorten the length of the device. Generally should keep 2cm longer than the length of incision. For example: if the length of surgical incision is 10cm, you should choose ZHQ-125.

4. The edge of surgical incision is about 5-10mm from the plastic beam when using the surgical skin closure.

5. use the adjustable device,adjust the width of the surgical skin closure to the suitable size.So as to adjust the width according to 6.7 steps, and then use the sleeve handle to tighten the connecting screw in clockwise to incision

6. If the incision is edema.the adhesive plaster is tightly connected.  the connecting screw can be Counter clockwise rotation by sleeve handle. increase the distance of two surgical skin closure to relax to the incision.

7. If the edema subsided,the adhesive plaster is too loose,loss of auxiliary tension,the connecting screw can be clockwise rotation by sleeve handle. narrowing the distance to provide a sense of comfort tension.

8.The device is typically used for 7 to 14 days, and it is removed by gently peeling from the skin.If you still need to maintain a fixed incision, you can replace a new one.

VI. Contraindications

Carefully use of skin allergy

VII.Precautions

1.Read the instructions carefully before using.

2. The closure can not be used if the package is damaged.

3.Sterilized by EO,This product shall not be repeated sterilization

4.For the safety of the incision, this surgical skin closure just assist healing, which can not be used in the subcutaneous and in vivo incision.

5.This surgical skin closure just  assist healing. making the incision healing more perfect, reducing  scar, cannot replace the surgical suture, the subcutaneous tissue must be sutured by the surgical suture to  ensure the safety of incision healing.

6. If necessary, the use of the surgical skin closure should consider  the drainage of the incision and the space needed for dressing.

7. Adhesive plaster can not be directly covered in the incision

8. The device is typically use for 5 to 7 days,If it fall off accidentally , should replace new one immediately.

9. The Used products should not be discarded at random , it should be treated in accordance with the treatment of medical waste regulations to avoid environmental pollution

VIII.Special Tips

1.1 one pair of surgical skin closure has one sleeve handle. The sleeve handle need to be used for several times. Should take care of the sleeve handle until the surgical skin closure is used, the sleeve handle is sterilized, It can be used directly for the first time, For the second time, before use, it should be sterilized by alcohol or iodine

2 To ensure the safety and perfection of the operation, the use of this surgical skin closure is recommended for the simultaneous use of surgical absorbable suture .

IX. Shelf life and Storage

The shelf life is 3 years from the manufacture date, the manufacture date is marked on the box.

This product should be stored in clean dry and well ventilated environment.