Medical Shaver Set Orthopedic Surgical Instruments with ODM and ISO13485 Curved Blade Machine

Medical Shaver Set with ODM Acceptance and ISO13485 Certified Curved Blade Machine

1 Introduction:
If you are looking for minimally invasive surgery medical instruments with good quality, competitive price and reliable service. Wanhe medical is manufaturing these for you. We provide general and professional laparoscopic instruments with CE, FDA approved.

2 Specifications
Adopt optimun stainless steel material
Tough construction
Corrosion resistance

FAQ

What are the requirements for the maintenance and care of minimally invasive orthopedic surgical instruments?

The maintenance and care requirements of minimally invasive orthopedic surgical instruments mainly include the following aspects:

Cleaning and disinfection:

After use, they should be cleaned immediately to remove attached blood and other organic matter. If immediate cleaning is not possible, the instruments should be pretreated or soaked in a pretreatment enzymatic solution with a neutral pH value after use by the patient.

The cleaning steps include: rinsing with warm water, thoroughly removing all blood and body fluids, soaking and cleaning with enzymatic detergent or deionized water, and ensuring that instruments of different metal categories are handled separately.
For high-precision equipment such as arthroscopy, it is recommended to perform bacterial culture once a month to ensure that they meet sterilization requirements.
Lubrication and rust prevention:

After each use, especially for the shaft joints, liquid paraffin or other rust-proof lubricants should be applied to prevent rust and corrosion.
Applying lubricants such as Miltex® Lube to the hinges can effectively protect the moving parts of the instrument.
Inspection and functional testing:

Before and after each use, routine inspections should be conducted to check whether all parts are complete, whether the joints are loose, and whether the performance is good.
Before surgery, select and check the instruments as needed to ensure that they are in good working order and free of damage.
For removable instruments, they should be air-dried in the operating room as much as possible; for wet cleaning, active disinfectants should be used and rinsed with clean water.
Storage and management:

The instruments should be kept by a dedicated person, handled strictly according to the operating procedures, positioned, regularly inspected, maintained and repaired.
Store in a dry and clean environment, avoid high temperature, high humidity, direct sunlight and water, and store separately from other metals to prevent corrosion.
For instruments with gap structures, such as drill bit sleeves, they should be thoroughly rinsed and cleaned immediately after each use.
Sterilization:

Lubricate the instruments before the disinfection cycle and after the last rinse cycle as recommended by the manufacturer, and use appropriate disinfection methods, such as ultrasonic cleaners, automatic washing machine disinfectors, etc.
The sterilization method is automatic sterilization at a temperature of 134°C for at least 3 minutes.
Professional maintenance:

Regular maintenance and inspection of the equipment by qualified professionals ensures that the equipment is in optimal working condition.
For battery-powered bone surgery instruments, users should check the equipment regularly and perform professional maintenance once within three years.
The above steps can effectively extend the service life of minimally invasive orthopedic surgical instruments and ensure the safety and effectiveness of the surgery.

What is the best cleaning and disinfection method for minimally invasive orthopedic surgical instruments?

The best cleaning and disinfection method for minimally invasive orthopedic surgical instruments requires comprehensive consideration of multiple steps and precautions to ensure thorough cleaning and effective disinfection of the instruments. The following is a detailed process:
Before cleaning, the instruments need to be pre-treated, including moisturizing, checking cleanliness, classification, and disinfection of special contaminated instruments. For contaminated instruments, soakers can be used for pretreatment.
Cleaning is a prerequisite for successful sterilization. First, remove blood stains from the postoperative instruments under running water, and then soak them in enzymes for more than 2 minutes or with ultrasonic vibration. For organic matter that is difficult to clean (such as blood and protein), pre-wash with warm water at about 40°C and then add detergent.
Common cleaning methods include washing and disinfection devices (WD) and ultrasonic cleaning, but it should be noted that some items (such as floating items, rubber products, etc.) are not cleaned well and may cause blade wear.

Rinse the instrument thoroughly with warm water to remove organic matter such as blood and tissue.

After ultrasonic cleaning, use a nylon soft brush to thoroughly clean all surfaces and rinse with running purified water for at least one minute.

Before disinfection, make sure that blood stains, grease and other dirt on the instrument are completely removed to avoid affecting the disinfection effect. Commonly used disinfectants include 2% glutaraldehyde distilled water solution for 10-30 minutes. You can also use new chlorhexidine solution, 70% alcohol, bus disinfectant, etc. For non-detachable lumen instruments, the screws should be screwed to the maximum opening, and the screws should be repeatedly screwed and slid back and forth from one side to the other when brushing.

The temperature should not exceed 120°C during drying to avoid damage to the instrument. Check whether there is visible dirt in areas such as cannulas and tube holes. If necessary, repeat cleaning or manual cleaning. Finally, oil and store in the instrument cabinet in categories.

How to correctly select and use anti-rust lubricants to extend the service life of minimally invasive orthopedic surgical instruments?

In order to correctly select and use anti-rust lubricants to extend the service life of minimally invasive orthopedic surgical instruments, you can refer to the following steps and suggestions:

Choose the right type of lubricant:

Choose the right lubricant according to the specific needs of the instrument. For example, water-soluble lubricants are suitable for high-pressure steam sterilization and ethylene oxide sterilization, and are non-oily, non-sticky and non-toxic.
Multi-functional lubricants such as CRC 5-56 anti-rust lubricant have the characteristics of rapid release and cover all contact surfaces, which can effectively prevent rust and corrosion.
Correct dilution and use method:

When hand washing, put the diluted solution into a non-porous container, dilute it at a ratio of 1:500 (add 2mL of this product to every 1000mL of water), and then completely immerse the cleaned instruments in the lubricant solution.
Soaking the cleaned medical instruments in the lubricant anti-rust solution for a certain period of time is simple to operate and can form a protective film on the surface of the medical instruments without scrubbing.
Avoid contamination and rust:

Lubricants can extend the life of surgical instruments by reducing friction and wear, and preventing contamination and rust.
In high temperature, high humidity, and high pollution environments, lubricants protect the surface of medical devices and prevent rust and corrosion of the instruments.
Maintenance and replacement:

Keep the lubricant clean and replace it with new oil in time to ensure its anti-rust performance.
Use rust inhibitors from brands such as ROCOL, such as Z25 volatile short-term anti-rust oil, to provide high-performance oily film and excellent anti-corrosion protection.

What are the functional test standards for minimally invasive orthopedic surgical instruments?

The functional test standards for minimally invasive orthopedic surgical instruments mainly cover the following aspects:

Performance in use: According to the "Registration and Review Specifications for Orthopedic Surgical Instruments (Class II)", if there are national standards or industry standards for orthopedic surgical instruments, the corresponding standards (such as YY 1122, YY/T 1127, YY/T 1135, YY 1137, etc.) should be implemented. For example, the rongeurs should be easy to open and close without swinging or getting stuck; after closing, the pliers heads should fit together without misalignment; the gill axis screws should be firmly fixed on the pliers and should not move when opening and closing.

Safety and effectiveness: For products in the same registration unit, select typical products that can represent the safety and effectiveness of other products in this unit for full performance testing or difference testing.

Electromagnetic compatibility (EMC): China's surgical robots have passed North American certification, based on a full range of industry latest standards such as product safety regulations, EMC electromagnetic compatibility, medical software, usability and robot performance standards (IEC80601-2-77).

General requirements for basic safety and main performance: The international version of the Tianji II orthopedic surgical robot has passed CSA certification and complies with the basic safety and main performance general requirements of IEC60601-1 medical electrical equipment.

Material testing: Although ISO 7153-1 does not apply to surgical instruments used in special applications (such as implantology and minimally invasive surgery), some standards may apply to these instruments. When selecting steel grades and raw material shapes, sizes, and delivery conditions for surgical instruments, the design of the instrument or the manufacturer's production facilities must be considered.

Range of motion and control accuracy: Endoscopes and surgical instruments of different design structures have been verified for the tip range of motion, as well as control accuracy and manipulation performance and image performance within the full range of motion, all of which meet the preset requirements.

How to effectively prevent corrosion and damage during the storage and management of minimally invasive orthopedic surgical instruments?
In the storage and management of minimally invasive orthopedic surgical instruments, the following measures can be taken to effectively prevent corrosion and damage:

Anti-corrosion coating: At least three layers of No. 100 (1 mil) anti-corrosion coating should be used when storing the equipment, and ensure that the tool is completely sealed, including the bottom. If possible, it should be stored in a closed, well-climate-controlled environment.

Desiccant: If there is no isolated storage space, silica gel desiccant is recommended to reduce the humidity in the package. When calculating the amount of desiccant required, it is necessary to measure the outer dimensions of the tool and calculate the air volume, and then convert it to cubic feet based on the recommended amount of silica gel desiccant.

Regular exercise: Equipment should be exercised regularly to maintain optimal anti-corrosion performance, and desiccant packs should be replaced regularly.

Cleaning and disinfection: Surgical bone forceps and medical instruments should be stored dry immediately after cleaning to prevent corrosion, discoloration and peeling. Movable parts should be coated with water-soluble lubricants, and zippered instruments should be stored without zippers. Neutral or near-neutral pH detergents and medical-grade detergents should be used for cleaning. If a cleaning device (such as a dishwasher) is used, make sure that the instruments do not touch each other. Distilled or deionized water should be used for cleaning, as channel water may contain residual chlorine and organic matter, which may cause corrosion, discoloration and peeling. After cleaning, disinfect or dry immediately. Leaving it wet for too long may cause surface corrosion, discoloration and peeling.

Sterilization method: Supports three sterilization methods: high-pressure steam sterilization, plasma sterilization and EOG sterilization. If there are other instructions, please follow their instructions.

Avoid rough operation: During maintenance and inspection, please avoid rough operation to avoid damaging key components such as the tip.

Corrosion resistance: Since surgical instruments need to come into contact with human tissue, they need to have good corrosion resistance to prevent adverse effects on the human body.

Easy to clean and disinfect: Orthopedic surgical instruments need to be cleaned and disinfected frequently, so appropriate disinfection methods should be selected, such as high temperature, ultraviolet rays, chemical disinfectants, etc.

Transport protection: During transportation, necessary protective measures should be taken to prevent the instruments from being damaged or contaminated. At the same time, attention should be paid to the control of temperature and humidity to avoid affecting the performance of the instruments.

What is the most effective method for sterilizing minimally invasive orthopedic surgical instruments, including temperature, time, and the type of equipment used?

The most effective method for sterilizing minimally invasive orthopedic surgical instruments is to use a pulsating vacuum pressure steam sterilizer for sterilization. The specific parameters are: vacuum degree of 0.076MPa, pulsation number of times 3 times, sterilization temperature of 134℃, and sterilization time of 6 minutes. This sterilization method has been mentioned many times in the literature and is considered to be the safest and most reliable sterilization method at present.

In addition, high-pressure steam is also one of the commonly used sterilization methods, including the bottom exhaust type and the pre-vacuum type. The bottom exhaust type kills microorganisms by increasing the steam pressure to 104.0-137.31 kPa and maintaining it for 30 minutes, while the pre-vacuum type first sucks the air to make it vacuum, and then directly delivers the steam to the disinfection chamber to ensure uniform distribution and shorten the time.

For surgical instruments that are not resistant to high temperatures, low-temperature sterilization technologies such as ethylene oxide (EOG) sterilization or low-temperature steam formaldehyde sterilization technology can be used. These methods may be more applicable in some cases, but it is necessary to select the appropriate sterilization method according to the material and characteristics of the specific instrument.

The preferred sterilization method for minimally invasive orthopedic surgical instruments is a pulsating vacuum pressure steam sterilizer, with the following parameters: vacuum degree 0.076 MPa, pulsation number 3 times, sterilization temperature 134°C, and sterilization time 6 minutes.

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Company Name: Tonglu Wanhe Medical Instruments Co., Ltd.
Sales: Aiden