厂商直供TOPCON拓普康角膜内皮显微镜SP-1P
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厂商直供TOPCON拓普康角膜内皮显微镜SP-1P
桂经理19117326863微xin同号
拓普康角膜内皮显微镜SP-1P
管理类别
第二类
型号规格
SP-1P
结构及组成/主要组成成分
该产品由主机（包括摄影头、控制面板、摄影窗、打印机、电源开关）和电源线组成，不包括前额托和颌托。角膜厚度测量允差±0.01mm（＜0.600mm），±0.025mm（＞0.600mm）。
适用范围/预期用途
该产品用于医院眼科对患者做角膜内皮细胞显微放大检测、摄像诊断及角膜厚度测量。
一、产品工作原理（Working Principle）
中文：采用非接触式镜面反射光学原理与高分辨率显微成像系统。通过红外光源投射，利用角膜内皮细胞层与房水的折射率差异形成镜面反射，捕捉内皮细胞的反射光信号。经高精度光学系统与自动对焦模块，实现254倍放大的细胞成像。设备内置智能图像处理算法，自动识别细胞边界，快速分析细胞密度（CD）、平均细胞面积（AVE）、变异系数（CV）、六边形细胞比例（HEX），并同步测量中央角膜厚度（CCT）。全景模式可自动拍摄中央、鼻侧、颞侧3区域图像并拼接，扩大分析面积至传统模式的2.6倍。English：Adopts non-contact specular reflection optical principle and high-resolution microscopic imaging system. Infrared light is projected, and specular reflection is generated by the refractive index difference between corneal endothelium and aqueous humor, capturing endothelial cell reflection signals. Through high-precision optics and auto-focus module, 254×magnified cell imaging is achieved. Built-in intelligent image processing algorithm automatically identifies cell boundaries, rapidly analyzing cell density (CD), average cell area (AVE), coefficient of variation (CV), hexagonality (HEX), and synchronously measuring central corneal thickness (CCT). Panorama mode auto-captures 3 images (central, nasal, temporal) and merges them, expanding analysis area to 2.6×of conventional mode.
二、核心功能（Core Functions）
中文
全自动内皮细胞分析：一键自动对焦、拍摄、分析，输出CD、AVE、CV、HEX、CCT全参数。
全景广角拍摄（Panorama）：三区域拼接，大幅提升低细胞密度患者的测量可靠性。
双拍摄模式
序列模式（Sequence）：预录患者信息，按区域有序拍摄存档。
自由模式（Free Style）：开机即拍，灵活切换拍摄区域。
角膜厚度测量：非接触式测量中央角膜厚度（CCT），范围400–750µm。
数据管理与报告：彩色直方图显示细胞形态，支持USB导出、打印、数据联网。
人体工学操作：10.4英寸可旋转触摸屏，360° 方位操作，无手柄设计。
English
Fully automatic endothelial analysis: One-touch auto-focus, capture, analysis; outputs CD, AVE, CV, HEX, CCT.
Panorama wide-angle imaging: 3-region merge, improves reliability for low cell density patients.
Dual capture modes
Sequence Mode: Pre-enter patient info, orderly capture by region.
Free Style Mode: Immediate capture, flexible area switching.
Corneal thickness measurement: Non-contact precise CCT (400–750µm).
Data & reporting: Color histograms; USB export, print, network connectivity.
Ergonomic operation: 10.4-inch rotatable touchscreen, 360°access, lever-free.
三、产品特点（Key Features）
中文
全景成像技术：分析面积扩大2.6倍，解决角膜内皮细胞稀疏时的采样不足问题。
全自动化：点击瞳孔中心即完成全程操作，3–5秒快速出结果。
超大触摸屏：10.4英寸可旋转彩屏，界面直观，支持触控笔操作。
高精度分析：分辨率＞125线/毫米，细胞参数测量、重复性好。
非接触安全：无接触、无损伤、无麻醉，降低交叉感染风险。
紧凑高效：机身小巧，节省空间，适配各类眼科诊室。
English
Panorama imaging: 2.6×larger analysis area, solves sampling issues in sparse endothelium.
Full automation: Tap pupil center to complete; results in 3–5 seconds.
Large touchscreen: 10.4-inch rotatable color display, intuitive UI, stylus support.
High-precision analysis: Resolution＞125 line/mm, accurate & repeatable cell parameters.
Non-contact safety: No touch, no trauma, no anesthesia; reduces infection risk.
Compact & efficient: Small footprint, space-saving, fits all ophthalmic clinics.
四、技术参数（Technical Specifications）
表格
参数项（Item）中文参数（Chinese Spec）英文参数（English Spec）
放大倍率254×（触控屏显示，±8%）Magnification254×(Display,±8%)
拍摄面积标准：0.25×0.55mm；全景：约1.43mm²Capture AreaStandard: 0.25×0.55mm; Panorama: ~1.43mm²
分辨率＞125线/毫米Resolution＞125 line/mm
角膜厚度（CCT）400–750µm（精度 ±10µm）CCT Range400–750µm (±10µm)
细胞密度（CD）300–6000个/mm²Cell Density300–6000 cells/mm²
固视标17点固视（中央+周边）Fixation Target17-point (central + peripheral)
显示屏10.4英寸彩色触摸屏，360° 旋转Display10.4" Color Touchscreen, 360°rotatable
数据接口USB、LANInterfacesUSB, LAN
电源AC 100–240V，50/60HzPowerAC 100–240V, 50/60Hz
尺寸350×480×520mmDimensions350×480×520mm
重量约22kgWeightApprox. 22kg
产品分类Ⅱ 类医疗器械（国械注进20152163367）ClassificationClass II Medical Device
五、使用方法（Usage Method）
中文
准备阶段
开机预热10分钟，清洁目镜、触摸屏、颌托、额托。
新建患者档案，录入姓名、性别、年龄等信息。
患者就位
患者坐正，下颌放颌托、前额顶紧，双眼自然睁开、注视固视标。
调整颌托高度，使眼裂与光路中心对齐。
自动测量
触控屏点击患者瞳孔中心，设备自动对焦、拍摄、分析。
切换全景模式：自动拍摄3区域并拼接，生成完整分析报告。
可手动调整亮度、对比度，优化图像质量。
数据保存
查看CD、CV、HEX、CCT等参数，保存图像与数据。
通过USB导出或直接打印报告。
结束操作
关闭电源，清洁光学部件与接触部位，覆盖防尘罩。
English
Preparation
Power on, warm up 10 min; clean optics, touchscreen, chin/forehead rest.
Create patient profile, input name, gender, age.
Patient setup
Seat patient, chin on rest, forehead firm; eyes open, fixate target.
Adjust height to align eyes with optical center.
Auto measurement
Tap pupil center on screen; auto-focus, capture, analyze.
Panorama mode: auto-capture 3 regions, merge, generate report.
Manual adjust brightness/contrast for optimal image.
Data saving
Review CD, CV, HEX, CCT; save images & data.
Export via USB or print report directly.
Completion
Power off; clean optics & contact parts; cover with dust shield.
六、适应症（Indications）
中文
白内障术前评估：测量内皮细胞密度（＜1500个/mm² 提示手术高风险）。
角膜疾病诊断：角膜内皮营养不良、Fuchs综合征、大泡性角膜病变。
屈光手术前后：LASIK/SMILE/ICL术前内皮筛查、术后监测。
角膜移植术后：监测植体内皮细胞密度与形态变化。
长期戴镜者：隐形眼镜佩戴者内皮健康年度检查。
眼外伤/青光眼：评估外伤、高眼压对内皮的损伤。
English
Pre-cataract evaluation: Measure endothelial density (＜1500 cells/mm²= high surgical risk).
Corneal disease diagnosis: Endothelial dystrophy, Fuchs’syndrome, bullous keratopathy.
Pre/post refractive surgery: LASIK/SMILE/ICL screening & monitoring.
Post-keratoplasty: Monitor graft endothelial density & morphology.
Long-term contact lens wearers: Annual endothelial health check.
Ocular trauma/glaucoma: Assess endothelial damage from injury/HTG.
七、禁忌症（Contraindications）
中文
急性眼部炎症：结膜炎、角膜炎、葡萄膜炎（避免刺激、感染扩散）。
严重角膜混浊/白斑：无法清晰成像，结果无效。
无法固视：眼球震颤、意识障碍、儿童不配合。
角膜穿孔/裂伤：急性期禁止检查，避免损伤加重。
光敏性癫痫：检查光源可能诱发发作。
English
Acute ocular inflammation: Conjunctivitis, keratitis, uveitis (irritation/infection risk).
Severe corneal opacity/leukoma: No clear imaging, invalid results.
Inability to fixate: Nystagmus, cognitive impairment, uncooperative children.
Corneal perforation/laceration: Contraindicated in acute phase.
Photosensitive epilepsy: Light may trigger seizures.
八、注意事项（Precautions）
中文
患者安全
检查前停戴隐形眼镜≥1周。
儿童、老人需专人协助固定头部。
光敏性患者缩短检查时间，必要时终止。
设备维护
光学部件用专用拭镜纸+无水乙醇清洁。
颌托、额托每次用后75%乙醇消毒。
避免碰撞、震动，定期校准光学系统。
环境要求
温度18–26℃、湿度≤65%、暗室、无强电磁干扰。
数据管理
定期备份数据，防止丢失。
禁止修改原始测量参数与图像。
English
Patient safety
Remove contact lenses≥1 week before exam.
Assist children/elderly with head fixation.
Shorten exam for photosensitive patients; stop if needed.
Device maintenance
Clean optics with lens paper + ethanol.
Disinfect chin/forehead rest (75% ethanol) after each use.
Avoid collision/vibration; calibrate optics regularly.
Environment
18–26°C, RH≤65%, dark room, EMI-free.
Data management
Back up data periodically.
Do not modify raw measurements/images.
九、存储条件（Storage Conditions）
中文
温度：-10℃～+40℃；相对湿度：10%～90%（无冷凝）。
气压：86kPa～106kPa；通风干燥、防尘、防腐蚀、防阳光直射。
长期存储：断电、光学部件密封、机身固定、覆盖防尘防潮罩。
禁止：靠近强酸强碱、有机溶剂、热源、强电磁设备。
English
Temp: -10℃～+40℃; RH: 10%–90% (non-condensing).
Pressure: 86kPa–106kPa; ventilated, dry, dust/corrosion-proof, no direct sun.
Long-term: Power off, sealed optics, secured body, dust/moisture cover.
Prohibited: Near acids, solvents, heat, strong EMI equipment.
十、说明书核心信息（Key Manual Inｆormation）
中文
分类：Ⅱ 类医疗器械，注册证：国械注进20152163367。
标准：符合YY 0069、IEC 60601-1、ISO 15004。
核心组件：光学成像系统、10.4英寸触摸屏、自动对焦模块、颌托系统。
维护周期：每日表面清洁；每周光学检查；每年校准。
保修：整机1年，光学组件2年；灯泡、触摸屏等耗材除外。
警示：非无菌；接触部件必须消毒；禁止改装、拆卸、非原厂配件。
English
Classification: Class II Medical Device, Reg No.: 20152163367.
Standards: YY 0069, IEC 60601-1, ISO 15004 compliant.
Core components: Optical imaging, 10.4" touchscreen, auto-focus, chin rest.
Maintenance: Daily clean; weekly optics check; annual calibration.
Warranty: 1yr whole unit, 2yr optics; consumables (bulb, screen) excluded.
Warning: Non-sterile; disinfect contact parts; no modification/disassembly/non-OEM parts.
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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