厂商供应视唯得准分子激光角膜屈光治疗机SCHWIND AMARIS 500E
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厂商供应视唯得准分子激光角膜屈光治疗机SCHWIND AMARIS 500E
桂经理19117326863微xin同号
桂经理19117326863微xin同号
管理类别
第三类
型号规格
SCHWIND AMARIS 500E
结构及组成/主要组成成分
产品由光学系统、平板计算机、电子装置、供气装置、1050Hz眼动跟踪系统、ArF准分子激光器、光学相干测厚仪（OCP）、眼球旋转矫正装置、眼球旋转控制装置及激光防护镜组成。
适用范围/预期用途
在医疗机构中使用，用于屈光手术中切削角膜组织，治疗的屈光度范围：+6.0D ~ -11.75D。
产品储存条件及有效期
1、工作原理 Working Principle
中文：设备采用 193nm 氩氟（ArF）准分子紫外冷激光，通过光化学消融作用，切削角膜组织，改变角膜曲率，矫正屈光不正；搭载 5D 眼动跟踪系统实时补偿眼球位移与旋转；ITEC 智能热效应控制动态分配激光脉冲，降低角膜局部温升；AFLA 自动能量密度调节优化切削平滑度；集成 OCP 光学相干测厚术中实时监测角膜厚度，保障手术安全。 English：The device adopts 193 nm ArF excimer ultraviolet cold laser, which precisely ablates corneal tissue by photochemical effect to modify corneal curvature for ametropia correction. Equipped with 5D eye‑tracking system to compensate ocular displacement and cyclotorsion in real‑time. ITEC intelligent thermal‑effect control dynamically distributes laser pulses to minimize corneal temperature rise. AFLA automatic fluence adjustment optimizes ablation smoothness. Built‑in OCP optical coherence pachymetry monitors corneal thickness intra‑operatively to ensure surgical safetySCHWIND ey...。
2、功能 Function
中文：1. 可开展 LASIK、TransPRK、PRK、LASEK 等各类角膜屈光手术，矫正近视、远视、散光；2. 支持 PTK 治疗性角膜切削；3. 可导入角膜地形图、波前像差数据，实现个性化切削；4.5D 眼球跟踪补偿眼球平移、旋转；5. 术中实时角膜厚度监测；6. 治疗流程辅助管理、手术录像存储、裂隙灯术后即时观察ManualsLib。 English：1.Perｆorm corneal refractive procedures including LASIK, TransPRK, PRK, LASEK for myopia, hyperopia and astigmatism correction. 2.Support PTK phototherapeutic keratectomy. 3.Import corneal topography and wavefront aberration data for customized ablation. 4.5D eye‑tracking compensates eye translation and cyclotorsion. 5.Real‑time intraoperative corneal thickness monitoring. 6.Treatment workflow assistant, surgical video recording, integrated slit‑lamp for immediate postoperative observationSCHWIND ey...。
3、产品特点 Product Features
中文：①500Hz 激光脉冲频率，1050Hz 五维眼动跟踪，可补偿眼球旋转；②0.54mm 超小光斑，AFLA 自动能量密度调节，切削面光滑；③ITEC 智能热效应控制，抑制切削热累积；④OCP 非接触在线角膜测厚，术中安全预警；⑤支持全激光 TransPRK 无瓣手术；⑥集成裂隙灯，电动旋转手术床与旋转激光臂；⑦CAM 软件支持个性化切削方案规划；⑧内置烟雾抽吸系统，清除切削气溶胶。 English：①500 Hz laser pulse repetition rate,1050 Hz 5‑D eye‑tracker with cyclotorsion compensation. ②0.54 mm ultra‑small spot; AFLA automatic fluence adjustment delivers smooth ablation surface. ③ITEC intelligent thermal‑effect control reduces heat accumulation. ④OCP non‑contact online pachymetry provides intra‑operative safety alarm. ⑤Support flap‑free TransPRK all‑laser procedure. ⑥Integrated slit‑lamp, motorized swivel patient bed and rotatable laser arm. ⑦SCHWIND CAM software for customized ablation planning. ⑧Built‑in plume aspiration system to remove ablation aerosolSCHWIND ey...。
4、技术参数 Technical Parameters
中文 - 激光类型：ArF 准分子激光 - 激光波长：193nm±5nm - 脉冲宽度：≤15ns - 脉冲重复频率：500Hz - 光斑尺寸：0.54mm (FWHM) - 输出单脉冲能量：0.8‑2.0mJ，允差 ±20% - 眼跟踪采样频率：1050Hz，5D 跟踪（X/Y 平移、Z 轴、旋转、 cyclotorsion 眼球旋转） - 角膜测厚：OCP 光学相干测厚 - 矫正屈光度范围：+6.0D ~‑11.75D - 供电：230VAC，50/60Hz - 配置组成：光学系统、平板计算机、电子装置、供气装置、1050Hz 眼动跟踪系统、ArF 激光器、OCP 光学相干测厚仪、眼球旋转矫正装置、激光防护镜等。
English -Laser Type:ArF Excimer Laser -Wavelength:193nm±5nm -Pulse Width:≤15ns -Pulse Repetition Rate:500Hz -Spot Size:0.54 mm(FWHM) -Single‑pulse Output Energy:0.8‑2.0 mJ,tolerance ±20% ‑Eye‑tracking Sampling Rate:1050 Hz,5D tracking(X/Y translation,Z‑axis,rotation,cyclotorsion) ‑Corneal Pachymetry:OCP optical coherence pachymetry ‑Correctable Refractive Range:+6.0D ~‑11.75D ‑Power Supply:230VAC,50/60Hz ‑Components:Optical system,panel PC,electronic unit,gas supply unit,1050Hz eye‑tracker,ArF excimer laser,OCP optical coherence pachymeter,cyclotorsion correction device,laser protective goggles etc。
5、使用方法 Operation Method
中文：1 术前完成验光、角膜地形图、角膜厚度等全套眼部检查，在 CAM 软件录入患者参数，生成切削方案；2 设备开机自检，完成激光能量校准，检查供气、烟雾抽吸系统；3 患者平卧于电动手术床，头部固定，调整床体高度，通过定位裂隙光将术眼对准激光光轴；4 开启眼动跟踪系统，确认眼球跟踪锁定；5 术者执行 LASIK/TransPRK 等对应术式，触发脚踏开关发射激光完成角膜消融切削，OCP 全程监测角膜厚度；6 切削结束，使用集成裂隙灯即时观察术眼；7 导出手术记录与录像，设备执行关机流程，做好设备清洁维护，更换耗材，登记设备运行日志ManualsLib。 English：1.Complete pre‑operative ophthalmic examinations including refraction,corneal topography and pachymetry.Input patient parameters into CAM software and generate ablation protocol. 2.Power‑on self‑test of the system,calibrate laser energy,check gas supply and plume aspiration system. 3.Patient lies supine on motorized bed,head stabilized.Adjust bed height,align surgical eye to laser optical axis via positioning slit light. 4.Activate eye‑tracking system and confirm stable eye lock‑on. 5.Surgeon perｆorms selected procedure(LASIK/TransPRK etc).Activate foot‑switch to fire laser for corneal ablation.OCP monitors corneal thickness throughout treatment. 6.After ablation,inspect eye immediately with integrated slit‑lamp. 7.Export surgical report and video.Shut down system properly.Clean equipment,replace consumables and record operation logManualsLib。
6、适应症 Indications
中文：医疗机构内用于角膜屈光手术，矫正近视、远视、散光；可开展 LASIK、TransPRK、PRK、LASEK、PTK 治疗性角膜切削；屈光度矫正范围 + 6.0D ~‑11.75D；年满 18 周岁以上，屈光状态稳定，适合角膜激光屈光矫正的患者；可基于角膜地形图、波前像差数据开展个性化切削治疗。 English：For corneal refractive surgery in medical institutions,to correct myopia,hyperopia and astigmatism.Procedures include LASIK,TransPRK,PRK,LASEK and PTK phototherapeutic keratectomy.Correctable refractive range:+6.0D ~‑11.75D.Patients aged ≥18 years with stable refraction suitable for corneal laser refractive surgery.Customized ablation based on corneal topography and wavefront aberration data is availableManualsLib。
7、禁忌症 Contraindications
中文：1 圆锥角膜、可疑圆锥角膜，严重角膜薄、角膜扩张；2 活动性眼部炎症、感染，严重干眼症未控制；3 青光眼、严重眼底病变、严重白内障；4 自身免疫性疾病、结缔组织疾病未控制；5 妊娠、哺乳期；6 瞳孔过大不适合手术；7 精神心理疾病，无法配合手术；8 角膜愈合障碍、严重眼表疾病；9 不符合角膜激光手术筛查标准的患者禁止使用该设备实施手术ManualsLib。 English：1.Keratoconus,suspected keratoconus,severe thin cornea or corneal ectasia. 2.Active ocular inflammation or infection,uncontrolled severe dry eye. 3.Glaucoma,severe fundus disease,severe cataract. 4.Uncontrolled autoimmune or connective tissue disorders. 5.Pregnancy and lactation period. 6.Excessively large pupil unsuitable for laser surgery. 7.Psychiatric disorders and inability to cooperate during operation. 8.Corneal healing disorders,severe ocular surface diseases. 9.Patients failing laser refractive surgery screening shall not receive treatment with this deviceManualsLib。
8、注意事项 Precautions
中文：1 本设备仅允许经过专项培训的眼科医师操作；2 严格执行术前筛查，评估角膜厚度、角膜形态、眼底、泪膜功能；3 手术环境满足洁净手术室要求，控制温湿度；4 定期做激光能量校准、光路维护、供气系统检查；5 激光工作时，人员佩戴专用激光防护镜，遵守激光安全规范；6 术中 OCP 提示角膜厚度接近安全阈值时，应停止手术；7 做好气溶胶抽吸防护，避免切削碎屑污染；8 术后规范随访，监测角膜愈合、眼压、屈光状态；9 禁止设备在超出额定参数条件下运行；10 设备故障禁止继续开展手术，联系厂家售后维修；11 耗材、氩氟激光气体使用原厂合规产品ManualsLib。 English：1.Only specially‑trained ophthalmologists are allowed to operate this device. 2.Strict pre‑operative screening including corneal thickness,corneal topography,fundus and tear‑film function. 3.Operation room shall meet clean‑operating‑room requirements with controlled temperature and humidity. 4.Perｆorm regular laser energy calibration,optical path maintenance and gas‑supply inspection. 5.All personnel shall wear certified laser protective goggles while laser is firing,comply with laser‑safety regulations. 6.Stop surgery immediately if OCP shows corneal thickness approaching safety threshold. 7.Ensure plume aspiration to avoid contamination by ablation debris. 8.Standard postoperative follow‑up for corneal healing,intraocular pressure and refraction. 9.Do not operate the device beyond rated parameters. 10.Do not perｆorm surgery in case of equipment failure;contact manufacturer service. 11.Use original certified consumables and ArF laser gas onlyManualsLib。
9、存储条件 Storage Conditions
中文：设备长期存放环境温度：+10℃~+35℃；相对湿度：20%‑80%，无冷凝；环境无腐蚀性气体、无粉尘、避免阳光直射；供电断电，做好防尘防护；激光气瓶按照高压气体安全规范存放；整机避免剧烈震动、碰撞；存放于干燥洁净室内环境。运输温度‑10℃~+50℃，湿度 10‑90% 无冷凝ManualsLib。 English：Long‑term storage temperature:+10℃~+35℃;relative humidity:20%‑80%,non‑condensing.Store in environment free of corrosive gas and dust,avoid direct sunlight.Power off the unit and take dust‑proof measures.Store laser gas cylinder according to high‑pressure‑gas safety rules.Avoid heavy vibration and impact.Keep in dry and clean indoor environment.Transport temperature:‑10℃~+50℃,humidity 10‑90% non‑condensingManualsLib。
10、说明书核心信息 Core Inｆormation of Instruction Manual
中文：该设备为 Ⅲ 类医疗器械，德国 SCHWIND 生产；用于角膜屈光矫正与 PTK 治疗性角膜切削；核心组件为 ArF193nm 准分子激光器、5D 眼动跟踪系统、OCP 在线角膜测厚；手术必须由受过专项培训眼科医师完成；严格术前筛查，术中依靠眼跟踪与 OCP 保障安全；需定期校准激光能量、维护供气、光路、抽吸系统；遵守激光安全防护；气体、耗材使用原厂配件；故障禁止手术；严格遵循原厂说明书与临床诊疗规范开展手术；存储运输避免冷凝、剧烈震动；术后规范随访。 English：This is Class Ⅲ medical device manufactured by SCHWIND Germany.Intended for corneal refractive correction and PTK phototherapeutic keratectomy.Key components:ArF 193 nm excimer laser,5D eye‑tracking system,OCP online pachymetry.Surgery must be perｆormed by specially‑trained ophthalmologists.Strict pre‑operative screening.Eye‑tracker and OCP ensure intra‑operative safety.Regular laser energy calibration;maintain gas supply,optical path and plume aspiration system.Comply with laser‑safety requirements.Use original gas and consumables.Do not perｆorm surgery under device failure.Follow original IFU and clinical standards.Storage and transportation:avoid condensation and heavy vibration.Standard postoperative follow‑up is required.
以上产品详情仅供参考，临床操作请以原厂纸质说明书为准。上海康世达医疗器械有限公司不生产医疗产品，所有产品均来自产品的生产厂家，代理商，经销商，如有侵权请联系我们，会尽快处理！The above product details are for reference only. All clinical operations shall be carried out in strict accordance with the original paper instructions for use issued by the manufacturer.
Shanghai Kangshida Medical Devices Co., Ltd. does not manufacture medical devices. All products are sourced from respective manufacturers, authorized agents and distributors.
Please contact us promptly in case of any infringement, and we will resolve the matter as soon as possible.
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