厂家供应Keeler睛乐间接检眼镜Vantage Plus Digital
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厂家供应Keeler睛乐间接检眼镜Vantage Plus Digital
桂经理19117326863微xin同号
管理类别
第二类
型号规格
Vantage Plus Digital; Vantage Plus Wireless; Vantage Plus Corded; All pupil II Wireless; All pupil II Corded; Spectra Iris
结构及组成/主要组成成分
产品由额头系统、充电器和电源适配器组成。
适用范围/预期用途
产品用于临床医疗单位做眼底视网膜疾症诊断和放大成像用。
工作原理（Working Principle）
中文采用双目间接立体眼底成像与数字化实时采集结合技术。头戴式光学系统通过高亮度 LED 光源投射光线，经智能光学系统（IOS）自动适配瞳孔大小，配合 20D/28D condensing lens 汇聚眼底反射光；双目显微镜（13° 立体会聚角）形成三维立体眼底视图，内置 320 万像素索尼高清摄像头同步捕捉光路图像，经 USB 3.0 实时传输至电脑，通过 Kinexis 软件实现眼底图像 / 视频的数字化观察、存储与分析。
EnglishCombines binocular indirect stereoscopic fundus imaging with digital real-time capture. The head-mounted optical system projects high-brightness LED light, automatically adapts to pupil size via Intelligent Optical System (IOS), and collects fundus reflected light through 20D/28D condensing lenses. The binocular microscope (13° stereo convergence angle) ｆorms 3D fundus view; a built-in 3.2MP Sony high-resolution camera synchronously captures optical path images, transmits to computer in real time via USB 3.0, enabling digital observation, storage and analysis of fundus images/videos through Kinexis software.
二、产品功能（Functions）
中文
双目立体眼底检查：三维观察视神经、视网膜、黄斑、血管及周边眼底结构
数字化图像采集：320 万像素高清实时拍照、录像，支持动态视频录制
智能光学适配：IOS 系统自动调节光路，适配大 / 中 / 小三种瞳孔（1-10mm）
多光斑 / 滤光模式：大 / 中 / 小光斑、无赤光、钴蓝光、扩散光，满足不同检查需求
高清放大观察：标配 Hi-Mag 1.6 倍附加放大，观察黄斑与视盘细节
数据管理系统：Kinexis 软件支持图像存储、报告生成、DICOM 导出、关联
教学与远程应用：实时画面共享，支持教学演示、远程会诊与案例记录
English
Binocular Stereo Fundus Exam: 3D observation of optic nerve, retina, macula, vessels and peripheral fundus
Digital Image Capture: 3.2MP high-res real-time photo & video recording
Intelligent Optical Adaptation: IOS auto-adjusts optics for large/medium/small pupils (1-10mm)
Multi-Aperture/Filter Modes: Large/medium/small spots, red-free, cobalt blue, diffused light
High Magnification: 1.6x Hi-Mag lens for detailed macula & disc view
Data Management: Kinexis software supports storage, reporting, DICOM export
Teaching & Telemedicine: Real-time sharing, demo, remote consultation
三、产品特点（Product Features）
中文
数字化一体化：传统双目检眼镜 + 高清数字采集，不改变临床操作习惯
索尼高清摄像头：320 万像素、高动态范围、低光灵敏度，图像清晰细腻
超大视野景深：视野覆盖完整 20D 透镜，景深达 100mm，检查更稳定
智能光学系统（IOS）：选光斑自动调光路，全瞳孔尺寸保持最佳立体视觉
独立相机调节：摄像头角度独立可调，不影响原有光学观察角度
长续航 LED 光源：4000K 中性白光，亮度可调，无红外 / 紫外，护眼安全
人体工学头戴：轻量化平衡设计，透气软垫，长时间佩戴舒适
专业软件支持：Kinexis 全流程管理，支持 DICOM、教学、远程会诊
English
Digital Integration: Traditional BIO + high-res digital capture, workflow unchanged
Sony HD Camera: 3.2MP, high dynamic range, low-light sensitivity
Ultra-Wide FOV & Depth: Covers full 20D lens, 100mm depth, stable imaging
Intelligent Optical System (IOS): Auto-adjusts for max stereopsis across pupils
Independent Camera Adjust: Camera angle adjustable without disrupting optics
Long-Life LED: 4000K neutral white, dimmable, IR/UV-free
Ergonomic Headset: Lightweight, balanced, breathable padding
Professional Software: Kinexis for workflow, DICOM, teaching, telemedicine
四、技术参数（Technical Specifications）
中文
型号：Vantage Plus Digital（EP59-09863）
光学系统：双目立体间接检眼镜，13° 会聚角
摄像头：320 万像素索尼 CMOS，USB 3.0 传输
光源：4000K LED，亮度 0-100% 可调，内置 IR/UV 截止滤片
光斑模式：大、中、小光斑，扩散光斑（宽光束）
滤光片：无赤光、钴蓝光、通透光
放大倍率：标准 + 1.6x Hi-Mag 附加放大
工作距离：50mm-100mm
适配瞳孔：1mm-10mm（全孔径自动适配）
供电：锂聚合物电池，续航≥4 小时，快充 2 小时
重量：约 680g（含电池）
软件：Kinexis（Win10/11），支持 DICOM、报告、图像导出
认证：CE、FDA、ISO 13485、YY 0065
English
Model: Vantage Plus Digital (EP59-09863)
Optics: Binocular indirect ophthalmoscope, 13° convergence angle
Camera: 3.2MP Sony CMOS, USB 3.0 transmission
Light Source: 4000K LED, 0-100% dimmable, IR/UV cut filter
Apertures: Large, medium, small, diffused wide beam
Filters: Red-free, cobalt blue, clear
Magnification: Standard + 1.6x Hi-Mag lens
Working Distance: 50mm-100mm
Pupil Adaptation: 1mm-10mm (auto IOS)
Power: Li-polymer battery, ≥4hrs, 2hr fast charge
Weight: ~680g (with battery)
Software: Kinexis (Win10/11), DICOM, reporting, export
Certifications: CE, FDA, ISO 13485, YY 0065
五、使用方法（Instructions for Use）
中文
准备
安装 Kinexis 软件，连接设备至电脑（USB 3.0）
调节头带、目镜屈光度，确保双目视野清晰重合
电池充电，选择 20D/28D condensing lens
患者准备
散瞳（必要时），告知检查流程，取坐位 / 卧位
表面麻醉（敏感患者），固视灯引导注视方向
检查操作
打开光源，调节亮度；选光斑（大 / 中 / 小）与滤光片
手持透镜置于患者眼前，调整距离与角度，形成清晰眼底像
观察同时点击软件拍照 / 录像，自动存储至患者
切换 Hi-Mag 放大观察黄斑、视盘细节
按象限检查全眼底，记录异常病变位置与形态
结束
关闭光源，断开连接，清洁光学面与透镜
软件整理图像、生成报告、导出 DICOM 数据
设备放回充电座，长期存储取出电池
English
Preparation
Install Kinexis, connect to PC (USB 3.0)
Adjust headband & eyepiece diopters for clear binocular view
Charge battery, select 20D/28D condensing lens
Patient Prep
Dilate pupils (if needed), instruct patient, seat/support
Topical anesthetic (sensitive), guide fixation
Examination
Turn on light, adjust brightness; select aperture & filter
Hold lens before eye, align for clear fundus image
Capture photos/videos via software, auto-save to chart
Flip Hi-Mag for macula/disc details
Examine all quadrants, document lesions
Completion
Turn off light, disconnect, clean optics
Compile images, generate reports, export DICOM
Dock for charging; remove battery for long storage
六、适应症（Indications）
中文
视网膜病变筛查：糖尿病视网膜病变、高血压视网膜病变、视网膜脱离、裂孔
视神经疾病：视神经炎、视神经萎缩、视盘水肿、青光眼视神经损害
黄斑病变：黄斑变性、黄斑裂孔、黄斑前膜、水肿
眼底先天异常：早产儿视网膜病变、视网膜色素变性、先天缺损
眼内炎症：葡萄膜炎、脉络膜视网膜炎、渗出与出血
眼内肿瘤：视网膜母细胞瘤、脉络膜黑色素瘤、转移瘤筛查
高度近视眼底、眼外伤、玻璃体病变评估
床旁、急诊、婴幼儿、老年人、行动不便者眼底检查
English
Retinal diseases: diabetic retinopathy, hypertension retinopathy, detachment, tears
Optic nerve: neuritis, atrophy, edema, glaucoma damage
Macular disorders: degeneration, hole, epiretinal membrane, edema
Congenital anomalies: ROP, retinitis pigmentosa, coloboma
Intraocular inflammation: uveitis, chorioretinitis, exudates/hemorrhage
Ocular tumors: retinoblastoma, melanoma, ｍmbedstases
High myopia, trauma, vitreous disorders
Bedside, ER, infants, elderly, immobile patients
七、禁忌症（Contraindications）
中文
角膜严重混浊、水肿、穿孔、活动性溃疡（无法清晰观察眼底）
急性结膜炎、角膜炎伴大量分泌物（污染光学系统）
严重青光眼、高眼压未控制（散瞳风险）
散瞳剂过敏、闭角型青光眼（禁忌散瞳）
眼球破裂伤、开放性眼外伤、眼内容物脱出
患者无法固视、严重眼睑痉挛、不配合（无法安全检查）
视网膜 / 脉络膜大出血、眼内炎急性期
English
Severe corneal opacity, edema, perforation, active ulcer
Acute conjunctivitis/keratitis with discharge (contaminates optics)
Uncontrolled severe glaucoma (risk with dilation)
Mydriatic allergy, angle-closure glaucoma (no dilation)
Ruptured globe, open injury, intraocular content prolapse
Inability to fixate, severe blepharospasm, non-cooperative
Acute massive hemorrhage, endophthalmitis
八、注意事项（Precautions）
中文
眼科 / 视光专业人员操作，需经数字化检眼镜专项培训
检查前评估眼压，闭角型青光眼禁用散瞳剂
光源亮度从低渐增，避免强光直射视网膜，控制照射时间
光学面用专用镜头纸清洁，禁用酒精等有机溶剂
每次使用后消毒透镜、探头与头带，防交叉感染
避免摔落、挤压、高温高湿、强磁场，保护光学与电子元件
充电仅用原厂充电器，长期存放每月补电一次
儿童 / 婴幼儿需成人固定头部，防意外碰撞
定期校准光学与摄像头，划痕透镜立即更换
English
Only trained ophthalmic/optometric professionals
Assess IOP first; no mydriatics for angle-closure glaucoma
Start low brightness, limit retinal exposure time
Clean optics with lens tissue only; no solvents
Disinfect lens, probe & headset after each use
Avoid drop, crush, heat, humidity, strong magnetic fields
Charge with original charger; recharge monthly long-term
Head stabilization for children/infants
Regular calibration; replace scratched lenses immediately
九、存储条件（Storage Conditions）
中文
温度：-10℃～+50℃
湿度：≤80% RH，无冷凝
环境：干燥、通风、清洁，远离腐蚀气体、酸碱、粉尘
放置：原装保护盒 / 充电座，光学面朝上，防震防压
长期存储：取出电池，密封防潮；避免阳光直射、剧烈震动
软件数据：定期备份图像与，存储于加密医疗服务器
English
Temperature: -10°C to +50°C
Humidity: ≤80%RH, non-condensing
Environment: Dry, ventilated, clean; away from corrosive gases, acids, dust
Storage: Original case/charger, lenses up, shock/pressure protected
Long-term: Remove battery, sealed dry; avoid sunlight, vibration
Data: Regular backup of images/records to encrypted server
十、说明书核心信息（Manual Core Inｆormation）
中文
分类：二类医疗器械（国械注进）
制造商：Keeler Ltd（英国温莎）
型号：Vantage Plus Digital（EP59-09863）
标准：ISO 13485、ISO 15004、EN 60601、YY 0065
保修：2 年（光学、摄像头、电池、耗材除外）
维护：每日清洁；每周消毒；每年专业校准一次
耗材：20D/28D 透镜、Hi-Mag 放大镜、备用电池、镜头纸
消毒：机身 70% 酒精擦拭；光学面专用清洁液 / 镜头纸
软件：Kinexis 授权，支持 Win10/11，终身免费升级
处置：按电子医疗废弃物规范处理
English
Class: Class II Medical Device (NMPA)
Manufacturer: Keeler Ltd, Windsor, UK
Model: Vantage Plus Digital (EP59-09863)
Standards: ISO 13485, ISO 15004, EN 60601, YY 0065
Warranty: 2 years (excl. optics, camera, battery, consumables)
Maintenance: Daily clean; weekly disinfect; annual calibration
Consumables: 20D/28D lenses, Hi-Mag lens, battery, lens tissue
Disinfection: Body 70% alcohol wipe; optics special cleaner
Software: Kinexis license, Win10/11, free lifetime updates
Disposal: Per electronic medical waste regulations
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.
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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