[Please ensure to refer to the instruction manual]
**[Generic Name]**
Elastic Stockings
**[Product Name]**
Ansilk-2
**[Contraindications/Prohibitions]**
Do not use on the following patients:
1) Patients with severe arterial blood flow disorders, congestive heart failure, or phlegmasia cerulea dolens. [There is a high risk of worsening symptoms due to compression.]
2) Patients with suppurative phlebitis. [There is a risk of developing or exacerbating bacteremia or sepsis.]
**[Precautions for Use]**
1. **Precautions (Apply with caution to the following patients)**
1) If use of this product causes pain, numbness, discoloration of the skin or nails, decrease in skin temperature, itching, rash, irritation, or any other abnormality or discomfort/unusual sensation not felt before wearing, discontinue use immediately. [There is a risk of developing arterial or venous blood flow disorders or neurological disorders.]
2) Exercise caution for patients whose application site has been immobile for a long time due to casts, trauma, etc., as they may have potentially developed deep vein thrombosis.
2. **Important Basic Precautions**
1) To obtain the correct compression pressure, always measure the specified areas of the application site and select the correct size of this product. Do not use if the size is outside the applicable range.
2) Do not fold over the product during use. [This may cause blood flow disorders or neurological disorders.]
3) To prevent excessive or insufficient compression pressure, wear the product without sagging or wrinkles. If the product sags, wrinkles, slips down, or is positioned incorrectly during wear, please re-apply it correctly. [Proper compression pressure will not be obtained, and there is a risk of causing blood flow disorders, neurological disorders, or pressure ulcers.]
4) If the circumference of any part changes during use due to reduction in swelling, etc., change to an appropriate size.
5) Ensure that the toe section does not roll up; if it does, pull it down as needed.
6) Check that the product is free of damage (runs, fraying, tears, etc.) before wearing. Do not use if there is damage, as proper compression pressure cannot be obtained.
7) As this product is a textile, please note that it may be damaged (runs, fraying, tears, etc.) in the following cases:
① Pulling up forcefully instead of pulling up gradually.
② Wearing on feet with long or curved nails.
③ Handling with rough hands or long fingernails.
④ Contact with sharp objects.
8) Do not modify or repair the product, such as by cutting it with scissors.
9) A person familiar with elastic stockings must explain the usage method to the wearer, and use should begin following the correct application procedure. If the product is to be used at home, provide the enclosed instruction manual to the user.
10) Check several times a day for changes in skin or nail color. Additionally, always remove and re-apply the product at least once a day to observe the entire leg.
11) Avoid contact with medicines such as ointments, oils, fats, or solvents, as they will degrade the fibers.
12) This product is for personal use; do not share it with others.
13) If layering this product with other compression stockings, a person familiar with stockings must make the judgment and provide guidance to the patient.
3. **Malfunctions and Adverse Events**
The following adverse events may occur with the use of this product:
1) **Serious Adverse Events**
① Blood flow disorders: If signs of blood flow disorders such as cyanosis, swelling, pain, numbness, or coldness of the skin appear, discontinue use immediately and take appropriate measures.
② Neurological disorders: If neurological disorders such as peroneal nerve palsy appear, discontinue use immediately and take appropriate measures.
③ Skin disorders:
- If skin disorders such as skin ulcers appear due to displacement or pressure from the product, discontinue use immediately and take appropriate measures.
- When used on patients with unstable peripheral circulation, such as those in shock, pay attention to blood flow at the application site, as blood flow disorders may occur, potentially leading to skin disorders such as gangrene.
2) **Other Adverse Events**
If skin disorders such as redness, blisters, itching, rash, or irritation appear at the application site, discontinue use immediately and take appropriate measures. Skin disorders may also appear after removing the product; in such cases, take appropriate measures as well.
**[Name of Marketing Authorization Holder and Manufacturer]**
1. **Marketing Authorization Holder**
Alcare Co., Ltd.
2. **Contact Information**
19th Floor, Arca Central, 1-2-1 Kinshi, Sumida-ku, Tokyo 130-0013
Customer Service Office: 0120-770-175
**[Intended Purpose or Effect]**
By applying gradually decreasing pressure from the periphery toward the center, this product reduces or prevents stagnation of venous blood and lymph in the lower limbs and promotes venous return.
- **Medical Device Classification:** General Medical Device
- **Medical Device Notification Number:** 13B1X00207000049
- **Specifications:** High socks, open toe
- **Ankle Compression Pressure:** 27hPa (20mmHg)
- **Size: M**
- Ankle circumference: 19–23 cm
- Calf circumference: 32–38 cm
- **Color:** Black
- **Quantity per box:** 1 pair
| Product # | B0779CG544 |
|---|
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