厂家供应意大利C.S.O.眼科综合测量仪Sirius+
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厂家供应意大利C.S.O.眼科综合测量仪Sirius+
桂经理19117326863微xin同号
桂经理19117326863微xin同号
管理类别
第二类
型号规格
Sirius+
结构及组成/主要组成成分
本产品由主机、头部托架、电源、连接电缆、电源线和Phoenix控制软件（发布版本：V4）组成。
适用范围/预期用途
产品在医疗机构中，用于通过非接触方式测量眼角膜厚度、角膜表面形状和人眼像差。
意大利 C.S.O Sirius + 眼科综合测量仪（三维角膜地形图‑眼前节分析系统）
1、工作原理 Working Principle
中文：设备融合 Placido 盘反射式角膜地形图与 Scheimpflug 眼前节断层成像技术。Placido 盘投射同心环到角膜前表面，通过环带反射图像解析角膜前表面曲率、高度；Scheimpflug 无紫外 LED 光源采集最高 100 层高分辨率角膜断层切片，重建角膜后表面、全角膜厚度、前房结构三维模型；搭配红外瞳孔成像光源，完成不同光照条件下瞳孔参数采集，软件算法完成眼前节多维度参数计算与图像重建。 English：The device integrates Placido‑disk reflective corneal topography and Scheimpflug anterior‑segment tomography. The Placido disk projects concentric rings onto the anterior corneal surface to analyze its curvature and elevation from reflected ring patterns. UV‑free Scheimpflug LED captures up to 100 high‑resolution corneal tomographic slices to reconstruct posterior corneal surface, full‑cornea pachymetry and 3‑D anterior‑chamber anatomy. Infrared pupillography light source acquires pupillary parameters under multiple lighting conditions, and software algorithms perｆorm multi‑dimensional calculation and image reconstruction of the anterior eye segment。
2、产品功能 Functions
中文：①角膜前后表面曲率、高度、屈光力分析；②全角膜厚度分布测量；③眼前节三维断层成像；④明视 / 间视 / 暗视多条件瞳孔直径测量；⑤角膜像差与客观视觉质量分析；⑥圆锥角膜筛查与角膜自动分类；⑦泪膜、睑板腺成像分析（干眼评估）；⑧基于光线追踪的人工晶体 IOL 计算；⑨屈光手术、白内障手术术前规划与术后随访对比；⑩前房角、前房深度生物测量，辅助青光眼筛查。 English：①Analysis of curvature, elevation and dioptric power for both anterior and posterior corneal surfaces；②Full‑cornea pachymetry mapping；③3‑D tomographic imaging of anterior eye segment；④Pupil‑diameter measurement under photopic, mesopic and scotopic conditions；⑤Corneal aberration and ｏbjective visual‑quality analysis；⑥Keratoconus screening and automatic corneal classification；⑦Tear‑film and meibomian‑gland imaging for dry‑eye evaluation；⑧Ray‑tracing‑based intraocular lens(IOL) calculation；⑨Pre‑operative planning and post‑operative follow‑up comparison for refractive & cataract surgery；⑩Biometry of anterior‑chamber angle and depth for glaucoma auxiliary screening。
3、产品特点 Product Features
中文：1）Placido 盘联合 Scheimpflug 双技术融合，同时获取角膜前后表面完整数据；2）高速成像，降低眼球运动带来的测量伪影；3）最大 12mm 角膜分析覆盖范围；4）无紫外 LED 光源，对眼部安全；5）角膜自动分类算法，区分正常、圆锥、疑似圆锥、术后角膜；6）支持屈光术后眼的人工晶体计算；7）集成干眼、睑板腺量化分级分析；8）可生成标准化临床报告，支持随访数据对比；9）分体式主机‑电脑架构，便于软件升级维护；10）测量精度符合 ISO19980 A 级标准。 English：1）Dual‑technology integration of Placido‑disk and Scheimpflug to obtain complete data of both corneal surfaces；2）High‑speed imaging reduces measurement artifacts caused by eye movement；3）Corneal analysis coverage up to 12 mm；4）UV‑free LED illumination for ocular safety；5）Automatic corneal‑classification algorithm for normal, keratoconic, suspected‑keratoconic and post‑surgical corneas；6）IOL calculation available for post‑refractive‑surgery eyes；7）Integrated quantitative grading analysis for dry‑eye and meibomian‑gland assessment；8）Standardized clinical reports and follow‑up comparison；9）Separate host‑PC architecture for easy software upgrade and maintenance；10）Measurement accuracy complies with ISO19980 Class‑A standard。
4、技术参数 Technical Parameters
中文
整机尺寸（高 × 长 × 深）：515 × 315 × 255 mm
整机重量：7 kg
Placido 盘环数：22 环
角膜分析直径：12 mm
Scheimpflug 切片数量：最高 100 层
工作距离：74 mm
颌托行程：70 mm±1 mm
底座 XYZ 移动范围：105 × 110 × 30 mm
光源：Placido (400‑700 nm)；Scheimpflug 无紫外 475 nm；瞳孔红外 940 nm；荧光 470 nm
供电：外置电源 24 V DC；输入 100‑240 VAC，50/60 Hz；功率 40 W
数据接口：USB3.0
屈光测量范围：1D‑100D
测量精度等级：ISO19980 A 级IF& F Serv...
English
Dimension(H×L×D):515 × 315 × 255 mm
Weight:7 kg
Placido disk rings:22
Corneal analysis diameter:12 mm
Max.Scheimpflug slices:100
Working distance:74 mm
Chinrest stroke:70 mm±1 mm
Base XYZ travel:105 × 110 × 30 mm
Light sources:Placido(400‑700 nm);UV‑free Scheimpflug 475 nm;Pupillography IR 940 nm;Fluorescein 470 nm
Power supply:External 24 V DC;Input 100‑240 VAC,50/60 Hz;Power 40 W
Data interface:USB3.0
Dioptric measurement range:1D‑100D
Accuracy class:ISO19980 Class‑A
5、使用方法 Operation Method
中文 1. 设备通电，连接配套计算机，启动 Phoenix 分析软件，完成设备自检； 2. 受检者取下角膜接触镜（软镜停戴≥7 天，硬镜停戴≥14 天），将下颌放置颌托，额头贴紧额托，调整颌托高度使眼位对齐光学通路； 3. 操作手柄移动主机，瞄准受检者瞳孔，软件自动对焦； 4. 触发采集，设备自动完成 Placido 地形图与 Scheimpflug 断层图像拍摄； 5. 软件自动运算生成角膜地形图、厚度图、眼前节三维模型、瞳孔测量等结果； 6. 选择报告模板，保存、导出或打印报告； 7. 完成检测，清洁颌托纸，关闭软件与设备电源，定期执行设备校准ManualsLib。
English 1.Power‑on the unit, connect to matched PC, launch Phoenix software and complete self‑test. 2.Patient removes contact lenses(soft lens ≥7‑day discontinuation;rigid lens ≥14‑day discontinuation).Place chin on chinrest, forehead against forehead rest.Adjust chinrest height to align eyes with optical path. 3.Move instrument via joystick, aim at patient pupil for software auto‑focusing. 4.Trigger acquisition;device automatically captures Placido topography and Scheimpflug tomographic images. 5.Software computes corneal topography, pachymetry map, 3‑D anterior‑segment model and pupillometry results. 6.Select report template, save, export or print reports. 7.Finish examination, replace chinrest paper, shut down software and power.Perｆorm periodic calibration as requiredManualsLib。
6、适应症 Indications
中文：用于人眼眼前节的眼科临床检查。适用于：圆锥角膜筛查、角膜形态异常评估；屈光手术术前评估、术后随访；白内障手术术前 IOL 参数测算；青光眼辅助筛查（前房角、前房深度测量）；干眼、睑板腺功能障碍评估；角膜接触镜适配评估；有晶体眼人工晶体术前术后检查；角膜外伤、角膜病变形态学分析；客观瞳孔参数测量，视觉质量评估。 English：For clinical ophthalmic examination of human anterior eye segment.Indications include:keratoconus screening & corneal abnormality evaluation;pre‑op assessment and post‑op follow‑up for refractive surgery;IOL biometry for cataract surgery;auxiliary glaucoma screening(anterior‑chamber angle & depth measurement);dry‑eye and meibomian‑gland‑dysfunction assessment;contact‑lens fitting evaluation;pre‑&post‑op examination for phakic IOL;morphological analysis for corneal trauma and corneal disease;ｏbjective pupillary‑parameter measurement and visual‑quality evaluation。
7、禁忌症 Contraindications
中文：1）受检者无法固视、不能配合头部定位；2）严重角膜浑浊、角膜大量分泌物、严重角膜水肿，无法获取有效光学图像；3）眼表急性感染、严重眼表破损；4）眼睑严重闭合不全，无法充分暴露角膜；5）眼部异物、眼内金属植入物（会影响成像及安全）。本设备仅为影像测量诊断设备，不用于治疗。 English：1)Patient cannot fixate or maintain stable head positioning.2)Severe corneal opacity,heavy corneal secretion or severe corneal edema preventing valid optical image acquisition.3)Acute ocular‑surface infection or severe ocular‑surface laceration.4)Severe eyelid‑malposition with insufficient corneal exposure.5)Ocular foreign‑body or intra‑ocular ｍmbedllic implant affecting imaging and safety.This device is for diagnostic measurement only, not for therapy.
8、注意事项 Precautions
中文 1. 软角膜接触镜需停戴至少 7 天，硬性接触镜至少 14 天再做检查，避免角膜形态失真； 2. 检查前确认眼表无大量分泌物，必要时清洁眼表； 3. 光学镜头严禁手触碰，清洁使用厂家指定无尘擦拭材料； 4. 颌托纸一人一换，做好接触部位消毒，避免交叉感染； 5. 避免强光直射设备光学窗口；设备远离强电磁干扰源； 6. 测量结果仅供医师临床综合参考，不可单独作为确诊依据； 7. 严格按照说明书周期执行设备校准； 8. 不可自行拆解设备；故障联系厂家售后，禁止非授权维修； 9. 禁止在手术室内使用未防护的便携式通信设备，规避电磁干扰。 English 1.Soft contact lenses shall be removed for at least 7 days, rigid contact lenses for at least 14 days before examination to avoid corneal‑shape distortion. 2.Ensure no excessive ocular‑surface secretion before measurement;clean ocular surface if needed. 3.Do not touch optical lenses by hand;use manufacturer‑approved lint‑free wipes for cleaning. 4.Replace chinrest paper for each patient and disinfect contact area to prevent cross‑infection. 5.Avoid strong direct light onto optical windows;keep away from strong electromagnetic interference sources. 6.Measurement results are for physician clinical reference only and shall not be used as sole diagnostic evidence. 7.Perｆorm calibration strictly according to manual schedule. 8.Do not disassemble device;contact manufacturer service for faults;unauthorized repair is prohibited. 9.Keep unshielded portable communication devices away to prevent electromagnetic interference in clinical environment.
9、存储条件 Storage Conditions
中文：存储环境温度：5℃‑40℃；相对湿度：10%‑85%（无冷凝）；大气压力：700‑1060 hPa；避光、防尘，远离潮湿、腐蚀性气体；设备长期闲置时断开电源，盖好防尘罩；运输避免剧烈震动与撞击。 English：Storage temperature:5℃‑40℃;Relative humidity:10%‑85% non‑condensing;Atmospheric pressure:700‑1060 hPa.Store in dark and dust‑free environment, away from moisture and corrosive gas.Disconnect power and apply dust‑cover for long‑term storage.Avoid violent vibration and impact during transportation.
10、说明书核心信息 Core IFU Summary
中文：本产品为眼科眼前节断层测量设备，采用 Placido 盘 + Scheimpflug 成像，用于角膜与眼前节形态、生物参数客观测量，辅助眼科疾病筛查及手术规划；测量结果必须结合临床症状、其他检查综合判读；必须使用原厂配件；定期校准维护；严格遵守消毒隔离要求；设备属于 A 类医疗设备，电磁环境需要符合眼科诊室要求；故障禁止自行拆机维修；废弃处置遵循当地医疗电子废弃物法规。 English：This is an ophthalmic anterior‑segment tomographic measuring device adopting Placido‑disk plus Scheimpflug imaging for ｏbjective morphological and biometric measurement of cornea and anterior‑segment, assisting ophthalmic disease screening and surgical planning.Measurement results must be interpreted together with clinical symptoms and other examinations.Only original‑manufacturer accessories shall be used.Perｆorm periodic calibration and maintenance.Observation of disinfection and infection‑control rules is mandatory.As Class‑A medical equipment, it shall be operated under ophthalmic‑clinic‑compliant electromagnetic environment.Do not disassemble on failure.Dispose according to local medical‑electronic‑waste regulations.
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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