مقدمة
Document Number: JM--QXWD--BB--02
تفاصيل
Ⅰ Product Overview
1. Product Usage
A gemstone surgical knife (also known as an artificial gemstone surgical knife) is an ophthalmic medical device that cuts eye tissue and can be reused
Equipment, mainly used for ophthalmic microsurgery, such as phacoemulsification cataract surgery, intraocular lens implantation, eye trauma, glaucoma
Various ophthalmic surgeries such as corneal transplantation and pterygium excision. The surgical knife can be reused after disinfection.
2. Product composition and functions
2.1. Structural composition
A surgical knife consists of two main components: a blade and a handle. The blade is made by bonding artificial corundum sheet and blade base; The handle of the knife is made up of a blade
Composed of parts such as handle shell, small shaft, compression spring, etc. The blade and handle components are connected by threads to form a whole blade.
2.2. Manufacturing Materials
2.2.1 The artificial corundum in the blade is made of ultra-thin artificial corundum (artificial gemstone) material with a hardness of up to Mohs 9
Good wear resistance, high blade sharpness after grinding, artificial corundum is a non corrosive material, suitable for ophthalmic surgical knives.
2.2.2 Except for artificial corundum, all other parts of the surgical knife are made of 06Cr19Ni10 and 06Cr17Ni12Mo2 stainless steel ("I")
Made of TC4 titanium alloy (represented by "II"), it has the properties of corrosion resistance and high temperature resistance, and can meet the needs of different users
2.2.3 The above materials can withstand high temperature and high pressure disinfection of the surgical knife before clinical surgery, and maintain the material and performance of the surgical knife
Change, so that the surgical knife can be repeatedly used after disinfection.
2.3. Product Features
2.3.1 Working principle
The blade is designed with specific geometric shapes and tip angles to form double-sided symmetrical straight edges, single-sided straight edges, or straight lines
Special blade combined with circular arc (currently there are fourteen types of blades, see JM-QXWD-B-02 II, Product Technical Specification)
To meet the different needs of various ophthalmic surgeries, this product can make subtle cuts to different parts of the eye, such as the eyeball, eliminating the hidden corners of the eye
Suffering.
2.3.2 Axial position adjustment and locking function of blade
The handle of the knife is not only used for holding the surgical knife during clinical surgery, but also has a blade axial position adjustment and locking mechanism inside the handle
Adjusting the position can put the blade in three different positions: when storing, retract the blade into the handle to protect it from being touched and damaged; During surgery, extend the blade to the first stop outside the handle; When replacing the blade, the blade can be extended to the outermost stop outside the handle.
By utilizing the blade position adjustment and locking mechanism, ensure that the blade is reliably locked in every working or holding position.
3. Use and maintenance of the product
3.1 1. Instructions for use
After disinfection and sterilization of the surgical knife, push the push rod forward along the adjustment groove on the handle shell to the positioning groove in the middle of the groove,
The blade extends out of the handle to reach the surgical position. After the surgery, clean it thoroughly and then retract the push rod along the groove to the positioning slot at the back for positioning,
The blade is retracted into the handle to protect it.
If the blade needs to be replaced, the push rod can be pushed to the front positioning slot of the groove, and then inserted into the blade base with a gauge insert
Turn the small hole counterclockwise to disassemble the blade; On the contrary, rotate clockwise to install the replaced blade.
3.2. Precautions
3.2.1 Disinfection and sterilization should be carried out before use, and use without disinfection is prohibited.
3.2.2 High pressure steam disinfection method is commonly used. The surgical knife is placed in a pressure steam sterilizer and sterilized at a high temperature of 125 ℃~128 ℃
20 minutes is enough.
3.2.3 Abandoned surgical knives should not be discarded arbitrarily and should be disposed of in accordance with hospital regulations.
3.3. Maintenance and upkeep
3.3.1 Surgical knives should be stored indoors at room temperature, with a relative humidity of no more than 80%, free of corrosive gases, dry, and well ventilated.
3.3.2 The surgical knife should not collide with other instruments to avoid damaging the blade.
3.3.3 After surgery, the surgical knife should be cleaned and washed for future use. If the tip or blade of the knife is found to be broken or cracked, it should be further cleaned
Changing the blade and continuing to use it will affect the surgical outcome.
4. Product expiration date: 5 years.
Ⅱ Product Technical Specifications
1. Product model, specifications, and basic blade dimensions
1.1. Model and specifications of gemstone surgical knife:
1.1.1 Gemstone surgical knife model: A-35 A-45、B-45 、 B-50、C-45、C-50、C2-15、C-15、C-A、C-B、E-1、
E-2、E-3、E-4。
1.1.2 Gemstone surgical knife metal material: I (stainless steel)
II (Titanium Alloy)
Note: The springs inside the gemstone surgical knife are all made of stainless steel; Except for the spring, all other metal parts containing stainless steel can only be classified as I (stainless steel); except
All other metal parts outside the spring must be made of titanium alloy to be classified as II (titanium alloy).
1.1.3 There are fourteen basic models of gemstone surgical knives, and their specifications are represented by the maximum width dimension W of the blade of that model,
(See Table 1).
1.1.4 Gemstone surgical knife model representation method: model+knife width W+metal material (blade base material/handle material)
For example: A-35 2.0 (I)
Model: A-35 Blade Width: 2.0 Metal Material: (Stainless Steel)
Besides the basic model, blades can be customized according to customer requirements within the range of 0.18-10mm.
1.2. Blade
1.2.1 Blade model: A-35 A-45、B-45 、 B-50、C-45、C-50、C2-15、C-15、C-A、C-B、E-1、E-2、
E-3、E-4。
1.2.2 Blade base material: I (stainless steel); II (Titanium Alloy)
1.2.3 There are fourteen basic models of blades, and their specifications are represented by the maximum width dimension W of the blade of that model (see Table 1)
1.2.4 Blade model representation method: model+blade width W+metal material (blade base material), such as A-35 2.0 (II).
1.3. Knife handle
1.3.1 Knife handle model: Straight knife handle (applicable to models A-35 A-45、B-45、B-50、C-45、C-50、C2-15、C-15
C-A、C-B）
Bending handle (applicable to models: E-1, E-2, E-4)
Large curved blade handle (applicable to model: E-3)·
1.3.2 Material of handle: I (stainless steel); II (Titanium Alloy)
1.3.3 Method for representing handle model: model (material), such as: straight handle (II)
Note: The springs inside the handle are all made of stainless steel; The metal parts containing stainless steel material other than the spring are referred to as I (stainless steel); Except for springs
All other metal parts are made of titanium alloy and belong to type II (titanium alloy).
1.4 Table of Specifications and Dimensions for Gemstone Surgical Knives (Fourteen Basic Models)
In surgical knife or blade models, the width W of the basic size represents its specifications.
2. Performance indicators
2.1. The surgical blade should not have any gaps or broken edges.
2.2. The blade of the surgical knife should be sharp, and when cutting 3-0 silk twisted uncoated suture thread (thread diameter of 0.21-0.249mm)
When cutting, the cutting force should not exceed 0.58N.
2.3. The basic dimensions of surgical knife blades should comply with the provisions in Table 1.
2.4. The surgical blade and blade base should be firmly connected without any looseness.
2.5. The surgical blade and handle should be firmly connected, easily disassembled, and easy to replace.
2.6. The blade locking and protective device on the handle should be easy to adjust, have appropriate elasticity, and have effective and reliable locking.
2.7. The appearance of the surgical knife should be free of sharp edges, burrs, cracks, dents, and stains.
2.8. The labels on the packaging of surgical knives should comply with the "Regulations on the Management of Medical Device Instructions and Labels" (National Food and Drug Administration)
According to the provisions of Order No. 6 of the General Administration of Administration.
3. Testing method
3.1. Appearance inspection
3.1.1 Use a 10X magnifying glass to inspect, and the blade edge should comply with the provisions of 2.1.
3.1.2 By visual observation, the appearance of the surgical knife should comply with the provisions of 2.7.
3.2. Dimensional Inspection
When measured with a vernier caliper, micrometer, or other measuring tool, it should comply with the provisions of 2.3.
3.3. Blade edge sharpness inspection
According to the test method specified in Appendix A of YY0174 standard, the test shall be conducted at the midpoint of the blade edge (double-edged or multi blade)
Each blade of the knife must be tested, and its cutting force should comply with the provisions of 2.2.
3.4. Connection fastness test
Place the blade in a pressure steam sterilizer and keep it at 125 ℃ for 20 minutes. The connection between the gemstone piece and the blade base should not be affected
Loose; Then, at room temperature, hang a 150g weight on one end of the gemstone piece, with its force direction aligned with the blade base
The axis should be perpendicular and applied for 1 minute. The connection between the gemstone piece and the blade base should not be loose and should comply with the provisions of 2.4.
3.5. The connection and disassembly of the blade and handle shall follow the action of blade disassembly and replacement, and visually and manually comply with the provisions of 2.5.
3.6. Inspection of locking protection device
Following the adjustment operation of the three blade positions, the visual and manual sensing comply with the provisions of 2.6.
3.7. Packaging label inspection
By visual observation, it should comply with the provisions of 2.8.
4. Terminology
4.1 Gemstone surgical knife
An ophthalmic surgical knife composed of a blade and a handle connected by threads, mainly used for cutting eye tissue.
4.2 Blade
Made by bonding artificial corundum blades (also known as gemstone pieces) and blade bases, the gemstone pieces are finely ground to ensure sharpness
High. The material of the blade base is stainless steel or titanium alloy.
4.3 Knife handle
Components made of stainless steel or titanium alloy processed into tool handle shell, small shaft, positioning sleeve, compression spring and other parts.
4.4 Blade Base
4.4.1 The blade base is a metal component bonded with gemstone chips and threaded, used to connect the blade and handle.
4.4.2 The blade base is commonly known as the "metal blade head". Due to the wide variety of blade models and specifications, depending on the shape of the blade base, the metal blade head may vary
Belonging to the blade head, they are also known as "straight blade head" and "curved blade head" respectively.
4.4.3 Considering the user's long-standing habit of referring to gemstone surgical knives and blades, this article or other related documents will continue to retain the term 'straight'
The names of "blade head" and "curved blade head", and the differences between straight blade head and curved blade head are shown in the 1.5 gemstone blade outline drawing.
