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Instruction for use
ACMED Reusable Ophthalmic Surgical Instruments
The ACMED Ophthalmic Surgical Instruments may only be used by suitably trained and qualified staff. The products are intended solely for the medical sector as illustrated below and must therefore be used within an operating environment suitable for this purpose. It is essential that both the user as well as the appropriate specialist staff familiarize themselves with the instruments before the user makes use of them.
ACMED Ophthalmic Surgical Instruments are intended to be used uninterrupted for a period of less than 24 hours under normal conditions.
For Ophthalmic Surgery.
This product should be used by a physician who is completely familiar with the indications, contraindications, limitations, typical findings and possible side effects of ophthalmic surgery.
No contraindications are known when used as intended.
No risk and side-effects are known when used as intended. |
l Prior to use, the instrument must be thoroughly inspected for correct function and possible damage.
l Please reprocess the product strictly according to the usage requirements.
l Do not use after the expiry date.
l Do not use or repair a damaged or defective instrument.
l Please notify Acmed Suqian Medical Technology Co., Ltd. if any instrument is received damaged or in a defective condition.
l As the instrument has a sharp tip, be aware of risk for injury during handling and disposal.
l Adhere to national regulations when disposing of or recycling the product, its components or packaging.
As the manufacturer here, Acmed Suqian Medical Technology Co., Ltd. shall not be liable for any damage or consequential damage arising from improper use or handling. This shall in particular apply to any use not in line with the defined purpose or failure to observe the preparation and sterilization instructions and warnings. This shall also apply to repairs or modifications to the product made by individuals who are not authorized to do so by the manufacturer.
Point of use
1) Following use, the instrument should be cleaned of excess soil using a disposable cloth/paper wipe as soon as possible.
2) The instrument should be kept moist to prevent soil from drying on the instrument.
3) The instruments should be reprocessed as soon as possible after performing procedural activities.
4) Always keep instruments in a suitable container and wrap to protect from contamination during transport to the decontamination area.
Cleaning
1) Place the product in running purified water and rinse for 5 minutes.
2) Put sufficient neutral multi enzyme detergent diluent (1:200) into the special soaking tank preheat it to 45℃, and then put the washed product into the soaking tank. The multi enzyme detergent should be able to completely immerse the product for 5 minutes: The negative instrument pairs still need to be soaked separately.
3) Brush the products one by one with a special soft brush in the soaking tank for 1 minute.
4) Rinse the brushed products one by one with flowing purified water for 5 minutes.
Drying
1) Dry the rinsed product with filtered high-pressure air, then put the washed product into a special drying basket and dry it at 70℃ for 20 minutes.
2)Put the dried products neatly into the disinfection box for standby.
Maintenance, Inspection and Testing
Following cleaning, inspect the instrument to ensure that all visible soil has been removed and that the instrument operates as intended. Carefully examine each surgical instrument for breaks, cracks, or malfunctions before use. Check areas such as blades, points, ends, and stops as well as all moveable parts. A microscope should be used whenever possible. Lubricate all moving parts, lock boxes, joints and catches with a physiologically safe lubricant.
Sterilization
l Use the sterilizer manufacturer’s instructions for the operation and loading of steam sterilizers. There must be direct steam exposure to all surfaces of the instruments being sterilized including the internal surface and tube channels.
l Unless otherwise indicated in the Instruction for Use provided with the specific instrument, instruments, and instrument trays may be sterilized by the following moist heat (steam) sterilization methods: Pre-vacuum High
l Temperature Autoclave, Standard Gravity Autoclave, High Speed (Flash) Autoclave (WARNING: Flash sterilization processing should be reserved for emergency reprocessing only and should not be employed for routine sterilization processing of the instrument. Flash-sterilized items should be used immediately, and not stored for later use. See your institution’s policies for restrictions regarding the use of flash sterilization.)
l Put the product into the disinfection box and place it neatly. Sterilize the Reusable forceps before each use, the sterilization method is pressure steam sterilization
Sterilization parameter:
Parameter | Numerical value |
Temperature | 121℃ |
Time | ≥20min. |
Pressure reference range | 102.8 Kpa-122.9 kPa. |
l Other time and steam temperature cycles may also be used. However, the user must validate any deviation from the recommended time and temperature. Contact the manufacturer of your steam sterilizer to confirm appropriate temperatures and sterilization times.
l The instrument and/or instrument tray should be processed through a complete sterilization drying cycle as residual moisture from autoclaves can promote staining, discoloration, and rust.
Delivery conditionThe product is non-sterilized. It can be reused and should be sterilized by steam before each time use by the users. |
| The service life of the product is typically 3 years after the date of manufacture under normal conditions. |
12. Function test
The medical devices must be checked with regard to the following aspects prior to use: · Expiration date · Undamaged packaging · Damage on the product ( bending, deformation) | |
Inspect products for immaculate surfaces, correct assembly and functionality Products that have failed the function test must not be used as their sterility and product safety cannot be ensured. Dispose of these products accordingly, or please return them to the manufacturer.
Do not place any objects on the instruments and/or their packaging Ensure the instruments are not kept near to chemicals, disinfectants or radioactive radiation |
Storage Ophthalmic Forceps should be stored in a room with a relative humidity of no more than 80%, no corrosive gas and good ventilation. |
After the use of the Reusable Ophthalmic Surgical Instruments:
l Firstly, rinse under flowing water to remove pollutants.
l Secondly, soak and scrub with medical cleaning agent, the water temperature should be 15-30℃.
l After cleaning, dry with drying equipment, drying temperature of 70℃-90℃.
l Finally, store the forceps in a room with a relative humidity of no more than 80%, no corrosive gas and good ventilation.
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