intra – ocular lens injector
Description:
Single Use Injector System are used for injecting the foldable intraocular lenses into the eye during cataract surgery.
Important Notice:
This product is a medical device. The package contains one sterile Single Use Injector System. It is highly recommended that the surgeon adheres to the instructions and warnings outlined in this Instructions For Use (IFU).
Indications:
Single Use Injector is intended for use in insertion of hydrophilic and hydrophobic intraocular lens during phacoemulsification cataract surgery.
Limitations:
· Forcing an implant through an inadequate incision results in trauma of the wound potentially causing an inability to self- seal.
Premature release of the implant with subsequent ocular injury and or damage to the implant.
· Folding and compression of the lens should be done prior to insertion and delivery. Failure to follow the instructions for use may result in patient injury.
· Injectors cannot be reused, as they are not designed to perform as intended after first and only usage. Changes in mechanical, physical or chemical characteristics, under conditions of repeated use, cleaning and resterilisation will compromise the integrity of injectors.
Re-use could lead to illness, infection and/or injury or in extreme incidents to the patient.
· Do not resterilise.
· Do not reuse. Single use only.
· Contents are sterile. Do not use if the sterile barrier system or packaging is opened or damaged.
· Do not use after expiry date.
· Discontinue lens delivery if excessive force is needed to advance the plunger and lens.
· Retain exterior packaging until enclosed device is used.
· Do not store Injector in direct sunlight or at temperatures below freezing.
· Discard the device if the labels and IFUs are with unclear or wrong information.
· A high level of surgical skill is required for intraocular lens implantation. The surgeon should have observed and/or assisted in numerous implantations and successfully completed one or more courses on intraocular lens implantation before attempting to implant intraocular lens.
· In case of serious incident occurred in relation to OriMed products, patients or surgeons shall report the case with details to Oriental Medical Devices Inc. and the competent authority.
NOTE:
Please dispose the injector and cartridge after the lens implantation.
Any form of change to the IOL injector is prohibited.
The IOL should not be placed in the folder for more than one minute.
Storage Conditions:
Keep away from sunlight.
Store at temperature between 5℃ – 25℃
Package:
Single use injector system is supplied individually packaged in sterilized pouch and outside package.
Note: Do not use if sterile pouch is opened or damaged
人工晶状体推注器是眼科手术中用于植入人工晶状体的重要器械，以下是关于它的详细介绍：
- 结构与原理
- 结构组成：通常由推杆、推注筒、晶状体装载槽、针头或植入头几部分构成。推杆用于推动人工晶状体，推注筒是容纳和引导人工晶状体的部分，晶状体装载槽用于放置人工晶状体，针头或植入头则是将人工晶状体送入眼内的末端部件，其设计需符合眼部解剖结构，以确保安全、精准植入。
- 工作原理：通过将折叠或卷曲状态的人工晶状体放入装载槽，然后利用推杆推动，使人工晶状体在推注筒内向前移动，最终从针头或植入头推出，植入到眼球的特定部位，一般是后房或前房，以替代原本病变或摘除的晶状体。
- 类型与特点
- 按操作方式分类：可分为手动推注器和自动推注器。手动推注器依赖医生手动操作推杆，能让医生根据手术实际情况灵活控制推注速度和力度，但对医生操作技巧要求较高。自动推注器则借助机械或电子装置实现推注，具有推注速度均匀、力量稳定的优点，可减少人为操作误差，提高手术的一致性和安全性。
- 按晶状体适应性分类：有单焦人工晶状体推注器、多焦人工晶状体推注器等。不同类型的人工晶状体形状、尺寸和材质有差异，推注器需根据其特点设计，以确保晶状体在推注过程中不损坏，且能准确植入。例如，多焦人工晶状体结构相对复杂，其推注器可能会有更精细的装载和推送设计。
- 作用与重要性：人工晶状体推注器是白内障等眼科手术中不可或缺的工具。它能将人工晶状体安全、精确地植入眼内，对于恢复患者视力至关重要。精准的植入可减少手术对眼部组织的损伤，降低术后并发症的发生风险，如晶状体位置异常、眼内炎症等，有助于患者术后视力的快速恢复和稳定。
- 使用注意事项：使用前，需严格检查推注器是否完整无损，有无污染，确保其处于无菌状态。装载人工晶状体时，要遵循规范操作，避免晶状体折叠不当或受损。推注过程中，需根据眼部情况控制推注速度，避免速度过快对眼内组织造成冲击，同时要密切观察晶状体的植入位置，确保其准确就位。使用后，应按医疗废弃物处理规定进行妥善处理。