Skin Tissue Punch
Table 1 – Dimensional Specifications of Product Structural Components (Unit: mm)
| Specification No. | Component | Outer Diameter (mm) | Inner Diameter (mm) | Total Length (mm) |
|---|---|---|---|---|
| 1 | Punch Needle | 0.7 | 0.5 | 164 |
| Sheath Tail Section | 3.0 | — | ||
| Sheath Head Section | 1.5 | 1.3 | ||
| 2 | Punch Needle | 0.8 | 0.6 | |
| Sheath Tail Section | 3.0 | — | ||
| Sheath Head Section | 1.5 | 1.3 | ||
| 3 | Punch Needle | 1.0 | 0.8 | |
| Sheath Tail Section | 3.0 | — | ||
| Sheath Head Section | 1.5 | 1.3 |
“—” indicates that no special dimensional requirements apply for the listed component.
Tolerance for inner and outer diameters: ±0.05 mm.
Tolerance for total length: ±2 mm.
Appearance and Cleanliness
The product surface shall be clean, free of dirt, defects, metallic debris, or impurities generated during manufacturing. The product shall be straight and have a regular circular shape.
Dimensions
The product dimensions shall comply with the specifications listed in Table 1 for each structural component.
Material
The product material shall conform to the requirements of 06Cr17Ni12Mo2 (SUS316) specified in Appendix A of GB/T 18457-2015.
Mechanical Properties
The rigidity and toughness of the punch needle and sheath tube shall meet the requirements stated in the product’s technical standards.
pH Value
The pH difference between the test solution and the blank solution shall not exceed 1.0.
Corrosion Resistance
The product’s corrosion resistance shall meet the requirements of Section 11 "Corrosion Resistance" in GB/T 18457-2015.
The device consists of a punch needle (with an external silicone protective sleeve), a clamping section, and a sheath tube, all made of stainless steel material.
It does not come into contact with the central nervous system or the blood circulatory system. The product is supplied non-sterile. Before use, it must be sterilized by the medical institution according to these instructions. The product is reusable and not intended for endoscopic use.
The punch needle is equipped with a silicone protective sleeve to ensure protection during handling and use. The product can be sterilized and reused as needed.
1. Intended Use
Used for tissue perforation and establishing microchannels.
2. Intended User Population
Patients assessed by qualified clinicians who require skin perforation or tissue sampling during surgery. There are no specific user restrictions.
3. Intended Use Environment
For use in medical institution operating rooms.
The product shall not be used on patients with skin ulceration or infection at the intended application site.
This product is intended for use by trained medical professionals only. Users must receive professional technical training before operation.
Please read the instructions carefully before use and follow all operational guidelines strictly.
The product is supplied non-sterile and must be sterilized according to these instructions before use.
Use moist heat sterilization.
Maintain a pressure of ≥103.4 kPa (1.05 kg/cm²) and a temperature of ≥125°C in a high-pressure sterilizer for at least 20 minutes.
Allow the product to cool before use.
During use, position the thumb and index finger of one hand on both sides of the sampling area and stretch the skin tightly.
With the other hand, hold the punch vertically, align the circular opening with the sampling site, apply gentle pressure, and rotate the punch.
Use forceps to lift and remove the circular cylindrical tissue sample from the incision.
When not in use, store the instrument in a dry and well-ventilated environment, avoiding humidity and prolonged exposure to moisture.
Classify and store the instrument according to its characteristics to prevent collisions and abrasion between different devices.
After each use, clean with medical-grade alcohol and sterilize before storage.
Store and transport the product in an environment with a temperature between -20°C and +45°C and humidity between 5% and 95%, without condensation.
Transport the product under sealed conditions to prevent exposure to rain or moisture.
Under the specified storage conditions, the product remains valid for 3 years from the date of manufacture.
The manufacture date and expiration date are indicated on the packaging label.
