Instructions for use

Medical device name: SI-Mesh
Medical device description: Silicone-Faced Wound Dressing Mesh Type

[Appearance] & [Gel layer cross section]

Type3, Type5                                   Type7, Type10, Type11

1. Gel layer
2. Peel-off film
3. Tab
4. Gel layer cross section
5. Base material Gel

[Product size]

Commodity code

| Type| Specification
(width x length)| Quantity per box
---|---|---|---
19601| No.3| 75mm x 75mm|

50 pieces

19602

| No.5| 100mm x 100mm| 50 pieces
19603| No.7| 100mm x 200mm|

50 pieces

19604

| No.10 | 200mm x 300mm| 10 pieces
19605| No.11 | 300mm x 550mm |

10 pieces

[Product color] * White

Intended use: Used to protect wounds and prevent sticking

1. Contraindications / Prohibitions

• Reuse prohibited

2. Shape / Structure

• This product is a non-stick wound dressing / protective material in which silicone gel, which does not stick to wet wound surfaces but adheres to skin, is applied to a mesh-like base material so as to be porous.
• This product is sterilized and packaged individually.

3. Principle

• Silicone gel applied to be porous has non-stick properties on wet wound surfaces.
• Blood, exudate, etc. from the wound pass through the pores of this product and are absorbed by the secondary dressing.

4. Instructions for use

4-1.Before application

(1) Cleanse the application site of this product and disinfect it as needed.
(2) Dry the peri-wound area sufficiently.
(3) Select the appropriate size enough to cover the whole wound area.

4-2. Application

(1) Hold the tab of the release film of this product, peel off the release film so that the gel surface is not touched, and apply to the wound.
(2) Place sterilized absorbent gauze of appropriate size on top of this product.
(3) Fix this product with an appropriate means such as adhesive tape or bandage, etc.

-Precautions-

• This product does not have a waterproof function.
• Since this product does not have a waterproof function, when showering or bathing, cover the secondary dressing with waterproof tape, etc., if necessary.

4-3. Replacement

(1) Replace it when necessary, considering the amount of exudate and the wound condition.
(2) Remove this product slowly while pressing the skin.
(3) If this product sticks to the wound surface, moisten the adhered part with distilled water or saline to soften it and then peel it off.

5. Precautions for use

5-1. Important basic precautions

(1) Discontinue use of this product and take appropriate measures if any symptoms considered skin disorders such as redness, erosion and itching appear during use.
(2) If there is a clinical infection on the wound surface, or if there is a risk of it, observe it frequently and take appropriate measures.
Also, pay careful attention in use especially when the health condition is bad.
[The symptoms may get worse.] (3) Observe carefully during use. Also, as a general rule, do not use for a long period of more than 30 days.

5-2. Defects / adverse events

[Defects / Adverse events] in the use of general wound dressings / protective materials

• Infectious symptoms of wound
• Wound and peri-wound skin disorders (epidermal detachment, maceration, edema, blister, redness, erosion, itching, allergy, contact dermatitis).
• Fixation
• Increase of necrotic tissue
• Pain

5-3. Other precautions

(1) Do not use if the sterile packaging is dirty or damaged, or if there is a risk of it.
(2) Use this product immediately after opening the sterilized packaging.
(3) In skin graft wounds, if this product is replaced before the skin graft is engrafted, the skin graft may be peeled off. Therefore, wait for the skin graft to engraft before replacing the product.
(4) Observe the sticking condition, and if exudate leaks, peeling of the surroundings, etc. occurs or is likely to occur, replace it with a new product immediately.
(5) Dispose of in accordance with all applicable local regulations.

6. Storage condition

• Avoid getting wet
• Store at room temperature, avoiding direct sunlight and high temperature and humidity.

7. SYMBOLS:

SYMBOLS

| Expiry Date
| Lot number

Expiry Date : Do not use beyond this date.
Lot number : Manufacturing identification number

[Importer information]

Importer : Marubeni Thailand Co., Ltd.
Address : 548 One City Centre Building, 32nd- 33rd Floor, Ploenchit Road, Lumpini, Pathumwan, Bangkok 10330
Phone : 02 256 6900

=====================================================
[Manufacturer information]

Manufacturer : ALCARE Co., Ltd.
Address : 19th floor, Arcacentral Building, 1-2-1 Kinshi, Sumida-ku, Tokyo, 130-0013, Japan =====================================================

• Prior to use, carefully read the instruction for use so that you understand the product’s features.
• Keep the instruction for use close at hand and read it again when needed.

ALCARE Co., Ltd
2306-02

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