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厂商Keeler睛乐裂隙灯显微镜3020-P-2007,KSL-H,KSL-Z系列
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厂商Keeler睛乐裂隙灯显微镜3020-P-2007,KSL-H,KSL-Z系列
桂经理19117326863微xin同号
管理类别
第二类
型号规格
一、H 系列（KSL-H）
1. KSL-H3（3 档放大：10×/16×/25×）
KSL-H3（3020-P-2090 / 3020-P-2091）：基础台式款Keeler Global
KSL-H3-D（3020-P-2093 / 3020-P-2094）：数码成像款Keeler
2. KSL-H5（5 档放大：6×/10×/16×/25×/40×）
KSL-H5（3020-P-2000 / 3020-P-2007）：基础台式款
KSL-H5-D（3020-P-2020）：数码成像款
KSL-H5-DR（3020-P-2010）：数码预留接口款
二、Z 系列（KSL-Z）
1. KSL-Z3（3 档放大：10×/16×/25×）
KSL-Z3（3020-P-2042）：基础台式款
KSL-Z3-D（3020-P-2045）：数码成像款
KSL-Z3-DR（3020-P-2048）：数码预留接口款
2. KSL-Z5（5 档放大：6×/10×/16×/25×/40×）
KSL-Z5（3020-P-2051）：基础台式款
结构及组成/主要组成成分
该产品由双筒显微镜、裂隙光源、调整旋钮、底座和分光器组件（选配，包含分光器、连接线及上位机软件）组成。
适用范围/预期用途
该产品在医疗机构中用于检查眼前节及眼内部病变，采集并存储的图片不作为临床诊断依据。
产品储存条件及有效期
一、工作原理（Working Principle）
中文基于光学切片（Optical Section） 与双目立体显微原理。由裂隙照明系统产生高亮度、可调节宽度 / 角度 / 长度的裂隙状强光（光刀），以一定角度投射至眼球；光线穿透角膜、晶状体等透明组织时产生散射，形成薄层光学切面。双目立体显微镜（伽利略 / 交角体视式）同步放大观察该切面，呈现眼前段组织三维立体结构与细微层次，清晰分辨病变位置、大小、深度及形态。
EnglishBased on the principles of optical sectioning and binocular stereomicroscopy. An illumination system generates a high-intensity, adjustable slit beam ("optical knife") projected at an angle into the eye. As light passes through transparent structures (cornea, lens), scattering creates a thin optical section. A binocular stereomicroscope (Galilean/angled stereoscopic) magnifies this section, providing 3D visualization of anterior segment anatomy, lesions, depth, and morphology.
二、产品功能（Functions）
中文
眼前段精细检查：清晰观察眼睑、结膜、角膜、巩膜、前房、虹膜、瞳孔、晶状体及玻璃体前 1/3
光学分层成像：窄裂隙形成组织断层，分辨角膜各层、晶状体皮质 / 核 / 后囊病变深度
多模式照明：直接 / 间接 / 弥散 / 后照 / 镜面反射照明，适配不同病变观察
滤光片专项检查：
钴蓝光：配合荧光素染色，观察角膜上皮缺损、渗漏
无赤光：增强血管对比度，观察结膜 / 虹膜血管病变
减光 / 隔热：保护视网膜、减少强光刺激
双目立体视觉：10–40 倍放大，三维空间感，判断病变层次
扩展功能：配合房角镜（前房角）、前置镜（眼底）、眼压计、摄像系统扩展应用
影像记录：内置 / 外接相机，实时拍照、录像、存储、打印病例图像
屈光 / 接触镜评估：隐形眼镜配适、角膜塑形镜验配、屈光术前筛查
English
Anterior Segment Micro-Examination: Visualizes eyelids, conjunctiva, cornea, sclera, anterior chamber, iris, pupil, lens, and anterior 1/3 of vitreous
Optical Section Imaging: Narrow slit creates tissue tomography; localizes depth in corneal ｌayers, lens cortex/nucleus/posterior capsule
Multi-Mode Illumination: Direct, indirect, diffuse, retroillumination, specular reflection for varied lesions
Specialized Filter Functions:
Cobalt Blue: Fluorescein staining for corneal defects/leaks
Red-Free: Enhances vascular contrast for conjunctival/iris vessels
ND/Heat: Protects retina, reduces glare
Binocular Stereo Vision: 10–40× magnification, 3D perception for precise depth assessment
Expandable Applications: Gonioscopy, fundoscopy (auxiliary lenses), tonometry, digital imaging
Imaging & Documentation: Built-in/external camera; real-time photo/video capture, storage, printing
Refractive/Contact Lens Assessment: Contact lens fitting, ortho-k, pre-refractive surgery screening
三、产品特点（Product Features）
中文
高清立体成像：大景深、低畸变、双目体视，三维细节清晰
全范围光学调节：裂隙宽度（0.1–14mm）、长度、角度（0–180°）、亮度无级调节
多档变倍：5 档转鼓 / 连续变焦（6.3×–40×），适配整体 / 细微观察
专业滤光系统：标配钴蓝、无赤、减光、隔热，覆盖全临床需求
精密机械平台：XYZ 三轴（0.1mm 级）微调，颏托 / 额带稳定固定
人体工学设计：操作顺滑、瞳距 / 屈光度独立调节，长时间操作舒适
冷光源节能：LED / 卤素，寿命长、低发热、无灼伤风险
数字化扩展：兼容高清摄像、软件分析、DICOM 对接，智能管理
安全：非接触、强光可控，无交叉感染、无眼表损伤
二类医疗器械：符合 ISO 15004、EN 60601、YY 0065 标准
English
High-Definition Stereo Imaging: Large depth of field, low distortion, binocular stereo for clear 3D details
Full Optical Adjustability: Slit width (0.1–14mm), height, angle (0–180°), intensity infinitely variable
Multiple Magnifications: 5-position drum/zoom (6.3×–40×) for overview/detailed exam
Professional Filter Set: Cobalt blue, red-free, ND, heat-absorbing; full clinical coverage
Precision Mechanical Stage: XYZ (0.1mm) fine adjustment, chin/head rest stable fixation
Ergonomic Design: Smooth operation, independent PD/refraction adjustment; comfortable prolonged use
Cold & Efficient Light: LED/halogen, long life, low heat, no burn risk
Digital Expansion: HD camera, analysis software, DICOM; smart EHR integration
Safe & Non-Invasive: Non-contact, controlled intensity; no infection/trauma
Class II Medical Device: ISO 15004, EN 60601, YY 0065 certified
四、技术参数（Technical Specifications）
中文
显微镜类型：伽利略平行夹角式 / 交角体视式
总放大倍率：6.3×、10×、16×、25×、40×（5 档转鼓）
目镜：10× / 12.5×，屈光度调节 ±6D～±8D
瞳距调节：50mm～82mm
视场直径：36.2mm（6.3×）～5.5mm（40×）
工作距离：35mm～50mm
照明光源：LED 冷光源（寿命＞10 万小时）/ 卤素灯
裂隙宽度：0～14mm 连续可调（14mm 为圆形光斑）
裂隙长度：1～14mm 连续可调
裂隙角度：0°～180° 垂直 / 水平连续旋转
滤光片：隔热片、减光片、无赤片、钴蓝片、黄色片
光阑孔径：0.2mm、1mm、3mm、5mm、10mm、14mm
机械移动：前后 115mm、左右 110mm、上下 30mm（微调 15mm）
颏托升降：80mm
供电：AC 100–240V，50/60Hz
尺寸重量：主机约 450×350×500mm；12–15kg
操作环境：+10℃～+35℃，30%–75%RH
认证：CE、FDA、ISO 13485、YY 0065
English
Microscope Type: Galilean parallel-angled / angled stereoscopic
Total Magnification: 6.3×, 10×, 16×, 25×, 40× (5-position drum)
Eyepieces: 10× / 12.5×, diopter adjustment ±6D to ±8D
PD Adjustment: 50mm–82mm
Field Diameter: 36.2mm (6.3×) – 5.5mm (40×)
Working Distance: 35mm–50mm
Illumination: LED cold light (>100k hrs) / halogen
Slit Width: 0–14mm continuous (14mm = round beam)
Slit Height: 1–14mm continuous
Slit Angle: 0°–180° vertical/horizontal rotation
Filters: Heat, ND, red-free, cobalt blue, yellow
Apertures: 0.2mm, 1mm, 3mm, 5mm, 10mm, 14mm
Stage Travel: Longitudinal 115mm, lateral 110mm, vertical 30mm (15mm fine)
Chinrest Height: 80mm
Power: AC 100–240V, 50/60Hz
Size/Weight: ~450×350×500mm; 12–15kg
Operating: +10°C to +35°C, 30–75%RH
Certifications: CE, FDA, ISO 13485, YY 0065
五、使用方法（Instructions for Use）
中文
设备准备
放置平稳台面，连接电源开机，预热 5 分钟
调节瞳距、目镜屈光度至清晰
清洁裂隙镜头、颏托、额带（70% 酒精）
患者准备
患者坐位，下颌置颏托、前额靠紧额带，头部固定
双眼自然睁开，注视固视灯，勿挤眼 / 转动眼球
检查操作
低倍（10×）、宽裂隙（3–5mm）整体观察眼睑、结膜、角膜
窄裂隙（0.1–0.5mm）、30°–45° 夹角，分层扫描：角膜→前房→虹膜→晶状体
病变部位切换高倍（16×–40×），配合滤光片（钴蓝 / 无赤）细节观察
需扩展检查：安装房角镜 / 前置镜，完成前房角 / 眼底观察
摄像：对准病变，按快门拍照 / 录像存储
结束
关闭光源、电源，清洁光学部件与机身
盖上防尘罩，定期校准（每年 1 次）
English
Equipment Preparation
Place on stable surface, power on, warm up 5 min
Adjust PD, eyepiece diopters for clarity
Clean slit lens, chin/head rest (70% alcohol)
Patient Preparation
Patient seated, chin on rest, forehead stabilized; head fixed
Eyes open, fixate on target; no squeezing/movement
Examination Procedure
Low power (10×), wide slit (3–5mm) for general survey (lids, conjunctiva, cornea)
Narrow slit (0.1–0.5mm), 30°–45° angle, ｌayer scan: cornea → AC → iris → lens
High power (16×–40×) + filters (cobalt blue/red-free) for lesion details
Advanced exams: Attach gonioscope/lens for angle/fundus view
Imaging: Frame lesion, capture photo/video
Completion
Power off light/main, clean optics/body
Cover with dust shield; annual calibration
六、适应症（Indications）
中文
眼前段疾病诊断：结膜炎、角膜炎、角膜异物 / 溃疡 / 瘢痕、青光眼（前房深度 / 房角）、虹膜睫状体炎、白内障（分级）、晶状体脱位、玻璃体混浊
眼外伤评估：眼球钝挫伤、穿通伤、异物定位、前房积血、虹膜损伤、角膜裂伤
屈光手术筛查：近视 / 远视 / 散光术前角膜形态、厚度、内皮、排除禁忌症
接触镜验配：隐形眼镜 / OK 镜配适评估、角膜并发症监测
眼科常规体检：健康人群、儿童、老年人眼病筛查
全身病眼部监测：糖尿病视网膜病变（前段）、高血压眼底、干燥综合征、自身免疫病
术后随访：白内障、青光眼、角膜移植术后愈合、炎症、并发症评估
English
Anterior Segment Diagnosis: Conjunctivitis, keratitis, corneal foreign body/ulcer/scar, glaucoma (AC depth/angle), iridocyclitis, cataract (grading), lens subluxation, vitreous opacities
Ocular Trauma Evaluation: Contusion, penetration, foreign body localization, hyphema, iris injury, corneal laceration
Refractive Surgery Screening: Pre-op corneal morphology, thickness, endothelium; rule out contraindications
Contact Lens Fitting: Contact lens/ortho-k assessment, corneal complication monitoring
Routine Ocular Exam: General population, pediatric, geriatric screening
Systemic Disease Ocular Monitoring: Diabetic retinopathy (anterior), hypertensive fundus, Sjögren’s, autoimmune disease
Post-Op Follow-Up: Cataract, glaucoma, corneal transplant healing, inflammation, complications
七、禁忌症（Contraindications）
中文
绝对禁忌：
眼球破裂伤、开放性眼外伤、眼内容物脱出（禁止加压 / 强光刺激）
角膜大面积穿孔、眼内炎急性期（感染扩散风险）
无法配合、严重眼睑痉挛、眼球震颤（无法稳定检查）
急性结膜炎 / 角膜炎（强传染性，检查）
相对禁忌（谨慎）：
角膜严重水肿、大泡性角膜病变（强光加重不适）
眼压极高（＞50mmHg）、急性闭角型青光眼发作期
眼表化学烧伤、热烧伤急性期（避免二次损伤）
English
Absolute Contraindications:
Ruptured globe, open trauma, intraocular content prolapse (no pressure/glare)
Large corneal perforation, acute endophthalmitis (infection risk)
Uncooperative, severe blepharospasm, nystagmus (unstable exam)
Acute conjunctivitis/keratitis (highly contagious; examine last)
Relative Contraindications (Caution):
Severe corneal edema, bullous keratopathy (glare worsens discomfort)
Severe IOP elevation (>50mmHg), acute angle-closure glaucoma
Acute chemical/thermal burn (avoid secondary trauma)
八、注意事项（Precautions）
中文
人员资质：眼科 / 视光专业人员操作，需培训合格
光源安全：避免强光直射瞳孔（尤其儿童 / 白内障），减少曝光时间
距离控制：物镜距眼≥35mm，禁止接触角膜 / 结膜
清洁消毒：每患者后清洁颏托 / 额带；光学部件仅用镜头纸 / 异丙醇棉签
机械保护：移动平台轻柔操作，禁止硬掰、撞击
患者配合：检查时禁挤眼、转头、说话，儿童需安抚 / 固定头部
感染控制：传染性眼病检查，检查后消毒
维护校准：年度强制校准，光学部件防潮防尘
电源安全：仅用原装适配器，长期不用切断电源
结果判读：结合放大、裂隙角度、滤光片综合判断，必要时复测
English
Personnel: Only trained ophthalmic/optometric staff
Light Safety: Avoid direct pupil glare (pediatric/cataract); minimize exposure
Distance Control: Objective ≥35mm from eye; no corneal/conjunctival contact
Cleaning: Disinfect chin/head rest per patient; optics: lens paper/isopropyl swab only
Mechanical Care: Smooth stage movement; no forceful bending/impact
Patient Compliance: No squeezing/movement/talking; pediatric restraint
Infection Control: Examine contagious cases last; full disinfection
Maintenance: Annual mandatory calibration; optics: moisture/dust protection
Power: Use only original PSU; disconnect when idle
Interpretation: Combine magnification, angle, filter for comprehensive diagnosis; recheck if needed
九、存储条件（Storage Conditions）
中文
温度：-10℃ ～ +55℃
湿度：10% ～ 95%RH，无冷凝
环境：干燥、清洁、通风，远离腐蚀气体、酸碱、粉尘、强磁场
放置：原装防尘罩，光学面朝上，防震、防压、防潮
长期存储：切断电源，清洁机身，密封防潮袋；避阳光直射、剧烈震动
运输：-40℃ ～ +70℃，湿度 10%–95% RH，气压 500–1060hPa
English
Temperature: -10°C to +55°C
Humidity: 10–95%RH, non-condensing
Environment: Dry, clean, ventilated; away from corrosives, acids, dust, strong magnetic fields
Storage: Original dust cover, optics up, shock/pressure/moisture protected
Long-Term: Disconnect power, clean body, sealed dry bag; avoid sunlight/vibration
Transport: -40°C to +70°C, 10–95%RH, 500–1060hPa
十、说明书核心信息（Manual Core Inｆormation）
中文
产品分类：二类医疗器械（国械注准 / 进）
制造商：国内外专业眼科设备厂商（如 Keeler、Zeiss、六六视觉）
型号规格：台式标准型（带 XYZ 平台）
执行标准：ISO 13485、ISO 15004、EN 60601-1/-2、YY 0065-2007
保修期限：2 年（光学部件、光源、耗材除外）
维护周期：每日清洁；每周光学保养；年度校准
耗材清单：镜头纸、清洁棉签、70% 异丙醇、热敏打印纸、防尘罩
消毒方式：机身 / 颏托：70% 异丙醇擦拭；光学镜头：专用棉签清洁
废弃处理：按 WEEE 电子医疗废弃物规范处置
处方要求：处方药，医疗机构、医师指导下使用
English
Classification: Class II Medical Device (NMPA/FDA/CE)
Manufacturer: Global ophthalmic leaders (Keeler, Zeiss, 66Vision)
Model: Standard desktop (XYZ stage)
Standards: ISO 13485, ISO 15004, EN 60601-1/-2, YY 0065-2007
Warranty: 2 years (excl. optics, lamp, consumables)
Maintenance: Daily clean; weekly optical care; annual calibration
Consumables: Lens paper, swabs, 70% isopropyl, thermal paper, dust cover
Disinfection: Body/chinrest: 70% isopropyl wipe; optics: specialized swabs
Disposal: Per WEEE electronic medical waste regulations
Preｓcription: Rx only, hospital use under physician supervision
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.
热门标签：厂商Keeler睛乐裂隙灯显微镜3020-P-2007KSL-HKSL-Z系列,睛乐裂隙灯显微镜,Keeler裂隙灯显微镜
