VV029604

【Product Name】Aspiration Handpiece
【Model and Specification】
Injection type, Aspiration type
【Product structure and composition】
This product consists of an injection-aspiration head, tube body, and tail seat. The injection-aspiration head is made of stainless steel conforming to GB/T 1220-2007, while the tube body and tail seat are made of titanium alloy materials conforming to GB/T 3624-2010. It is provided non-sterile and is reusable. Sterilization should be performed by the user institution before use according to the instructions.
【Intended use】    
For rinsing eye tissues or aspirating fluids.
【Indications】
Primarily used in cataract phacoemulsification surgeries and similar procedures.
【contraindication】
1. Do not use in individuals allergic to the stainless steel or titanium alloy materials used in this product.;
2. Surgical site infection is prohibited.
【caution】
1. This product should be used by professional medical personnel, please read all instructions before use;
2. According to the purpose of use, choose the appropriate model, and follow the usual surgical procedures when using;
3. Do not use the product if any abnormal conditions such as damage or defect are observed;
4. This product is non-sterile, please thoroughly clean, dry and sterilize the product before use.
【Matters needing attention】
1.    Strictly prohibit compression or collision with other instruments;
2.    Avoid using chlorine-based cleaning agents;
3.    Do not use the method of tossing to place sharp or pointed instruments in carriers;
4.    Do not use solutions containing salt or bleach for cleaning instruments; prolonged exposure to direct sunlight can cause material corrosion and rust;
5.    Do not allow stainless steel instruments to come into contact with oxides or any acids, disinfectants, salts, phenols, potassium, mercury, bleach, or other chemicals;
6.    Products discarded after use must be disposed of as medical waste in accordance with local laws and regulations.
【Instructions for use】
1. Before use, please check the product without damage, missing;
2. Users should wear sterile gloves for operation;
3. Handle gently when using;
【Sterilization method】
The equipment should be sterilized by the high temperature and high pressure steam sterilization method commonly used in the hospital before use.
【Cleaning instructions】
1.    Rinsing: Clean surface contaminants off the instrument and rinse for at least one minute, using a tailpiece-connected water rinse for the interior of the instrument for more than one minute;
2.    Ultrasonic cleaning: Place the rinsed instrument in an ultrasonic cleaner and clean for at least 10 minutes;
3.    Rinsing: Rinse with pure or distilled water for at least one minute, again using a tailpiece-connected water rinse for the interior of the instrument for more than one minute;
4.    Connect an air gun to the tailpiece to dry the interior of the instrument;
5.    Drying: Place in an oven and dry at a temperature of 70-80°C for no less than 40 minutes.
【Sterilization instruction】
1.    Please sterilize the product according to the hospital cleaning and sterilization procedure;
2.    We recommend high temperature and high pressure steam sterilization:
2.1    Standard high-temperature and high-pressure cycle: 134℃, 220Kpa steam sterilization lasts for 4 minutes, other time and steam temperature cycles can also be applied. However, the user needs to verify the deviation of the time and steam temperature before use, especially the sterilization temperature and pressure increase may damage the instrument;
2.2    Please contact the manufacturer of your steam sterilization equipment to confirm the appropriate temperature and time for sterilization.
2.3    The temperature of high-pressure steam should not exceed 140°C; otherwise, the lifespan of non-metallic parts of the instrument may be reduced.
2.4    Using plasma sterilization may decrease the lifespan of the instrument and is not recommended.
【Transport and storage】
1.    During transportation, the product should be protected from heavy pressure, exposure to sunlight, and rain. It should be stored in a dry and clean environment with temperatures between 0°C and 45°C, relative humidity not exceeding 95%, and free of corrosive gases.
2.    General transportation vehicles are permissible, but the product must be protected from severe impacts, vibrations, and exposure to rain or snow during transit. Handle with care, load and unload gently, avoid heavy pressure, and stack no more than 5 layers high. Packaging should ensure that the product is not damaged during transport.
【package】
The minimum packing method is: 1 package box contains 1 product.
【Production date/expiration date】
Date of production see label. Expiration date N/A.

【Name of registrant/manufacturer】
VisionVentions LLC
【Domicile of registrant/production enterprise】
12920 NE 125th Way Kirkland, WA USA
【Production address】
12920 NE 125th Way Kirkland, WA USA
【After-sales service unit】
VisionVentions LLC
【After-sales service address】
12920 NE 125th Way Kirkland, WA USA
【Phone】
+1 425 753 0833
【E-mail】
info@visionventions.com
【WEBSITE】
www.visionventions.com
【Revision date】
March 10, 2026
【Document number】
IFU-VV029604