厂家供应欧科路眼科检查仪77000
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厂家供应欧科路眼科检查仪77000
桂经理19117326863微xin同号
管理类别 第二类 型号规格 77000
结构及组成/主要组成成分 产品由主机、Keratograph软件（型号：77130，发布版本：V2）、电源线和连接线组成。 适用范围/预期用途 产品在医疗机构使用，用于拍摄眼表图像、测量角膜地形图及泪河高度。
一、工作原理 / Working Principle
中文设备通过 Placido 盘投射技术、泪膜干涉成像（TF-Scan） 与 红外摄像 三大核心原理工作：
角膜地形图：投射同心圆 Placido 环于角膜表面，高分辨率 CCD 相机捕捉反射图像，经算法计算出超过 22,000 个测量点，重建角膜前表面曲率、高度及形态 3D 模型。
干眼分析（TF-Scan）：利用白光干涉原理，非接触式分析泪膜脂质层厚度、泪河高度、泪膜破裂时间（TF-BUT），生成脂质层厚度热力图。
瞳孔监测：内置红外相机在明 / 暗环境下连续捕捉瞳孔图像，分析瞳孔直径、反应速度及偏心距。
EnglishOperates via three core principles: Placido Disc Projection, Tear Film Interferometry (TF-Scan), and Infrared Videography:
Corneal Topography: Projects concentric Placido rings onto the cornea. A high-res CCD camera captures reflections; algorithms calculate >22,000 data points to reconstruct a 3D model of corneal curvature, elevation, and shape.
Dry Eye Analysis (TF-Scan): Uses white light interferometry to non-invasively analyze lipid ｌayer thickness, tear meniscus height, and tear film break-up time (TF-BUT), generating a thickness heatmap.
Pupillometry: Built-in IR camera continuously captures pupil images under scotopic/photopic conditions to analyze diameter, reactivity, and decentration.
二、产品功能 / Functions
中文
角膜地形图分析：测量角膜曲率、屈光力、散光、高度图、KPI 指数，用于圆锥角膜筛查、屈光手术规划。
干眼评估（TF-Scan）：非接触测量泪河高度、泪膜破裂时间、脂质层厚度分级、睑缘分析。
瞳孔功能监测：明 / 暗视下瞳孔直径、眩光状态下瞳孔反应、瞳孔中心定位。
接触镜适配（CL-Fitting）：RGP 与 OK 镜验配设计、OxiMap 隐形眼镜透氧性分析。
图像管理：自动对焦、15 张连续拍摄选优、术前术后对比、数据导出（DICOM/PDF）。
English
Corneal Topography: Measures curvature, power, astigmatism, elevation maps, KPI for keratoconus screening & refractive surgery planning.
Comprehensive Dry Eye (TF-Scan): Non-contact tear meniscus height, TF-BUT, lipid ｌayer grading, lid margin analysis.
Pupillometry: Mesopic/photopic pupil diameter, glare response, pupil center location.
Contact Lens Fitting (CL-Fitting): RGP & Ortho-K design, OxiMap oxygen permeability analysis.
Imaging Management: Auto-focus, 15 consecutive shots, pre/post-op comparison, DICOM/PDF export.
三、产品特点 / Product Features
中文
三合一全能平台：单台设备完成角膜地形图、干眼分析、瞳孔测量，一机多用。
非接触：全程不接触眼球，无麻醉、无不适，患者舒适度高。
超高精度：22,000+ 测量点，微米级分辨率，早期圆锥角膜筛查。
智能自动化：自动对焦、自动拍摄、自动分析、自动报告，操作简便。
干眼准：全球领先 TF-Scan 技术，0.1µm 脂质层解析，可视化干眼诊断。
临床高效：单眼检查 <10 秒，连续拍摄确保优质图像。
医用级安全：IPX8 防水镜头、无接触脚踏控制、低光辐射、多重安全认证。
English
3-in-1 Platｆorm: Combines topography, dry eye, & pupillometry in one device.
Non-Contact & Safe: No touch, no anesthesia, patient-friendly.
Ultra-High Precision: 22,000+ data points, micron resolution for early keratoconus detection.
Smart Automation: Auto-focus, capture, analysis, & reporting.
Gold Standard Dry Eye: Leading TF-Scan with 0.1µm lipid ｌayer resolution.
High Efficiency: <10 sec per eye, burst mode for best image.
Medical Safety: IPX8 waterproof, touch-free pedal, low glare, certified.
四、技术参数 / Technical Parameters
表格
项目 Item 中文 Chinese 英文 English
型号 77000 (Keratograph 5M) 77000 (Keratograph 5M)
注册证 国械注进 20252160160 CFDA I20252160160
测量原理 Placido 环，干涉成像，红外摄像 Placido Ring, Interferometry, IR
测量点 ≥22,000 个 ≥22,000 points
测量范围 角膜直径 6.0–12.0mm Corneal diameter 6.0–12.0mm
曲率半径 5.0–11.0mm Radius 5.0–11.0mm
屈光力 25.0–65.0D Power 25.0–65.0D
泪膜分析 脂质层厚度、泪河高度、BUT Lipid ｌayer, TMH, BUT
瞳孔测量 0.1mm 精度，明 / 暗 / 眩光 0.1mm precision, scotopic/photopic
拍摄速度 15 张 / 次连续拍摄 15 shots per acquisition
显示 12.1 英寸 彩色液晶触屏 12.1-inch color touchscreen
数据接口 USB, LAN, DICOM 3.0 USB, LAN, DICOM 3.0
电源 AC 100–240V, 50/60Hz AC 100–240V, 50/60Hz
尺寸 / 重量 45×55×50cm / 28kg 45×55×50cm / 28kg
五、使用方法 / Usage
中文
准备：开机自检，清洁镜头，调整座椅与颌托高度，嘱患者摘除隐形眼镜。
校准：仪器自动光学校准，确保对焦系统正常。
患者就位：下颌置托、额头贴紧，注视内固视灯，保持头部稳定。
选择程序：角膜地形图 / 干眼分析 / 瞳孔测量。
自动采集：按脚踏或触屏启动，仪器自动对焦、连续拍摄 15 张并选优。
分析报告：软件自动计算、生成图表与报告，医生审核。
结束：数据保存 / 导出，清洁仪器，关机。
English
Prep: Power on self-test, clean lens, adjust chair/chinrest; patient removes contacts.
Calibrate: Auto optical calibration.
Position: Chin on rest, forehead against bar, fixate internal target.
Select Mode: Topography / Dry Eye / Pupillometry.
Auto Capture: Activate via pedal/touchscreen; auto-focus, 15 shots, best image selection.
Analyze: Auto calculation, charts, report; physician review.
Finish: Save/export data, clean, power off.
六、适应症 / Indications
中文
角膜疾病：圆锥角膜、角膜散光、角膜术后形态评估、角膜外伤 / 炎症。
屈光手术：术前检查（LASIK/SMILE/ICL）、术后随访、风险评估。
干眼诊断：脂质异常型、水液缺乏型、混合型干眼分级与疗效监测。
接触镜验配：高散光 / 圆锥角膜 RGP、OK 镜设计、透氧性评估。
瞳孔功能：瞳孔异常、眩光评估、人工晶体选择、低视力评估。
视疲劳与视光：视疲劳病因分析、不规则散光诊断、视觉质量评估。
English
Corneal Diseases: Keratoconus, astigmatism, post-op evaluation, trauma/inflammation.
Refractive Surgery: Pre-op (LASIK/SMILE/ICL), post-op follow-up, risk assessment.
Dry Eye Diagnosis: Lipid, aqueous deficient, mixed dry eye grading & follow-up.
Contact Lens Fitting: High astigmatism/keratoconus RGP, Ortho-K design, OxiMap.
Pupillary Function: Anisocoria, glare, IOL selection, low vision.
Asthenopia & Optometry: Eye strain, irregular astigmatism, visual quality.
七、禁忌症 / Contraindications
中文
绝对禁忌：无绝对禁忌症（非接触、）。
相对禁忌 / 慎用：
急性结膜炎、角膜炎、角膜溃疡（急性期避免刺激）。
严重眼表损伤、大量分泌物（影响图像质量）。
无法固视、精神异常、不配合患者（结果不可靠）。
眼球震颤、严重斜视（测量误差大）。
English
Absolute: None (non-contact, non-invasive).
Relative/Caution:
Acute conjunctivitis, keratitis, corneal ulcer (avoid irritation).
Severe ocular surface damage, discharge (poor image quality).
Uncooperative, unable to fixate (unreliable results).
Nystagmus, severe strabismus (measurement error).
八、注意事项 / Cautions
中文
环境：室温 18–26℃、湿度 40–60%、无尘、无强光直射、防震。
患者：检查前 ≥2 小时 摘隐形眼镜；不化妆、不涂眼霜；保持睁眼、固视。
操作：专业人员；勿用手触镜头；定期校准（每月）；脚踏轻踩。
安全：IPX8 防水但勿浸泡；低功率光源，避免直视；电磁环境合规。
数据：结果需结合临床；自动分析需医生复核；定期备份数据。
English
Environment: 18–26°C, 40–60%RH, dust-free, anti-glare, shockproof.
Patient: Remove contacts ≥2hrs prior; no makeup/eye cream; keep eyes open & fixated.
Operation: Trained staff only; no finger on lens; monthly calibration; gentle pedal use.
Safety: IPX8 waterproof (do not submerge); low-power light; EMC compliant.
Data: Correlate with clinic; auto-analysis needs physician review; backup regularly.
九、存储条件 / Storage
中文
环境温度：5–40℃
相对湿度：30–75%RH，无冷凝
环境要求：通风、干燥、清洁、避光、防尘、防震、远离腐蚀性气体。
运输：防潮、防震、防倒置、原包装固定。
长期存储：每月通电 30 分钟；镜头盖保护；干燥剂防潮。
English
Temperature: 5–40°C
Humidity: 30–75%RH, non-condensing
Environment: Ventilated, dry, clean, dark, dust/shock/corrosion free.
Transport: Moisture/shock proof, upright, original packaging.
Long-term: Power on 30min/month; lens cap; desiccant.
十、说明书核心信息 / Manual Highlights
中文
设备全称：OCULUS Keratograph 5M 眼科检查仪（77000）。
核心模块：Placido 角膜地形图、TF-Scan 泪膜分析、红外瞳孔监测、CL-Fitting 软件。
测量精度：角膜 22,000+ 点，脂质层 0.1µm，瞳孔 0.1mm。
临床价值：屈光手术安全筛查、干眼客观诊断、圆锥角膜早期发现。
维护周期：每日清洁、每周消毒、每月校准、每年工程师维护。
安全标准：符合 IEC 60601-1、IEC 60601-1-2、MDD 93/42/EEC、CFDA 认证。
质保：整机 2 年，光学系统 5 年。
English
Full Name: OCULUS Keratograph 5M Ophthalmic Analyzer (77000).
Core Modules: Placido Topography, TF-Scan, IR Pupillometry, CL-Fitting.
Precision: 22,000+ corneal points, 0.1µm lipid ｌayer, 0.1mm pupil.
Clinical Value: Refractive surgery safety, dry eye ｏbjective diagnosis, early keratoconus.
Maintenance: Daily clean, weekly disinfect, monthly calibrate, annual service.
Compliance: IEC 60601, IEC 60601-1-2, MDD, CFDA certified.
Warranty: 2 years whole unit, 5 years optics.
Shanghai Kangshida Medical Devices Co., Ltd. is a professional company engaged in the sales of medical devices, focusing on the agency and distribution of renowned medical equipment brands from both domestic and international markets. Its core product range covers full-scenario medical devices for physical examination, diagnosis, emergency treatment, laboratory testing, ultrasound, medical analysis, life sciences, disinfection and sterilization, rehabilitation therapy, operating rooms, emergency rooms, consulting rooms and other fields. Relying on its strong product sales capacity, excellent commercial reputation and integrity-based operation philosophy, the company has won unanimous recognition and trust from medical institutions and partners.
The steady and rapid development of the company is attributed to its carefully selected high-quality product portfolio. It always takes customer needs as the core orientation and is committed to creating long-term value and practical benefits for customers. As an authorized and exclusive agent for many well-known domestic and international manufacturers, the company has established a complete supply system of medical devices with reliable quality, fully meeting the needs of clinical diagnosis and treatment.
The company always takes improving customer satisfaction as its core goal. To strictly adhere to product standards and exceed the expectations of customers and manufacturers, it regularly provides training on professional ethics and professional business skills, forging a highly competent, efficient and executive team covering business, technology and management. The team implements a 7×24-hour all-weather response mechanism to provide professional and high-quality after-sales service and technical support, efficiently solving various equipment operation and maintenance problems. At the same time, the company offers exclusive services including same-day delivery and free distribution, ｆorming a closed loop covering supply, distribution and after-sales service to fully ensure the stable supply and worry-free use of medical equipment for medical institutions.
Upholding integrity as the foundation of its business, the company selects high-quality medical devices and provides professional services for customers, helping to upgrade the quality of medical services and contributing to the high-quality development of China's medical industry.
Intellectual Property Infringement Complaint: Kangshida Medical does not manufacture medical products; all products are sourced from original manufacturers. We will promptly address any intellectual property infringement issues.The content published herein is for reference only.
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