VV027005
【Product Name】Eye Speculum
【Model and Specification】
Wire type, adjustable type, translation type, spring type, injection type
【Product structure and composition】
It is usually composed of a head and a stalk, with a rounded, blunt end. Generally made of stainless steel. Non-sterile delivery.
【Intended use】
Used to dilate and support eye tissue.
【contraindication】
1. People who are allergic to the stainless steel material used in this product are forbidden to use it;
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】
The head should be protected and handled gently during cleaning and sterilization of this product;
It is strictly prohibited to squeeze and collide with other instruments;
Avoid using chlorine cleaning agents;
4. It is strictly prohibited to place sharp or sharp instruments in the vehicle by throwing them away;
5. It is strictly prohibited to use salt or bleaching solution to clean the instrument or direct sunlight for a long time, otherwise it will lead to corrosion and rust of the material;
6. Do not allow stainless steel equipment to come into contact with oxides or any acids, disinfectants, salts, phenols, potassium, mercury, bleach and other chemicals;
7. Products discarded after use shall be treated 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;
4. After use, store the device in a suitable disinfection box and protect the head.
【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. Manual cleaning: Use special cleaning agent and soft brush to clean instrument contaminants;
2. Rinse: rinse for at least 1 minute;
3. Ultrasonic cleaning: Put the rinsed instrument into ultrasonic cleaning, cleaning for at least 10 minutes;
4. Rinse: Rinse with pure water or distilled water for at least 1 minute;
5. Drying: Put it in the oven and use the temperature of 60-70℃ for drying, drying time is not less than 40min.
【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.
【Transport and storage】
1. The product should be protected from heavy pressure, sun exposure and rain during transportation. Products should be stored in 0℃-45℃, relative humidity does not exceed 90%, no corrosive gas, dry and clean environment;
2. Allow the use of general means of transportation, but must avoid severe impact, vibration and rain and snow splash during the transportation process, should be light, light unloading, not heavy pressure, stacking up to 5 layers. The packaging should ensure that the product is not damaged during transportation.
【package】
The minimum packing method is: 1 package box contains 1 product.
【Production date/expiration date】
Date of production see label. It can be stored for 5 years under the specified transport and storage conditions.
【Production record certificate number】
NO. SSYJXSCB20182013
【Product record certificate number】
NO. SSXB20181017
【Product technical requirement number】
NO. SSXB20181017
【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】
【Revision date】
September 06, 2024
【Document number】
IFU-VV027005 Rev. A