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厂家拓普康OCT眼科光学相干断层扫描仪3D OCT-1 Maestro2
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厂家拓普康OCT眼科光学相干断层扫描仪3D OCT-1 Maestro2
桂经理19117326863微xin同号
拓普康眼科光学相干断层扫描仪3D OCT-1 Maestro2
管理类别
第二类
型号规格
3D OCT-1 Maestro2
结构及组成/主要组成成分
该产品由主机、电源、颌托部、眼前节附件（选配件）及分析软件（IMAGEnet 6 for OCT）组成。
适用范围/预期用途
本品用于观察、拍摄以及记录眼底图像、眼前节图像和眼底断层图像（包括OCT血管成像功能（OCT Angiography）），并提供电子图像用于诊断。安装可选配件眼前节附件后，可以观察、拍摄以及记录眼前节断层图像。
一、产品工作原理（Working Principle）
中文：采用谱域光学相干断层扫描（SD-OCT）技术，通过宽带光源发射低相干光，经光纤耦合器分为参考光与测量光。测量光投射至眼内，经视网膜等组织不同深度反射后，与参考光发生干涉。高速光谱仪（50,000 A-Scans / 秒）捕捉干涉信号，经傅里叶变换解析，重构出微米级分辨率的眼部二维断层与三维立体图像。设备同步集成彩色眼底照相功能，实现 OCT 结构图像与眼底彩照的配准（PinPoint Registration），并可通过 **OCT-Angiography（OCT-A，选配）** 技术，无需造影剂即可呈现视网膜脉络膜微血管血流分布。English：Adopts Spectral-Domain Optical Coherence Tomography (SD-OCT) technology. A broadband light source emits low-coherence light, split into reference and sample beams by a fiber coupler. The sample beam penetrates the eye, reflects from ocular tissues at varying depths, and interferes with the reference beam. A high-speed spectrometer (50,000 A-Scans/sec) captures interference signals, which are processed via Fourier transｆorm to reconstruct micrometer-resolution 2D cross-sectional and 3D volumetric images of the eye. The device integrates true-color fundus photography for PinPoint Registration of OCT structural images with color fundus photos. OCT-Angiography (OCT-A, optional) enables visualization of retinal and choroidal microvascular flow without contrast injection.
二、核心功能（Core Functions）
中文
全自动三合一成像：一键自动完成对齐、对焦、采集，同步获取 OCT 断层、彩色眼底、红外眼底图像。
3D 广角扫描：最大12mm×9mm扫描范围，单次覆盖黄斑与视盘，提供全景视网膜信息。
智能分层分析：自动分割 ** 视网膜神经上皮层、RPE、脉络膜、RNFL、GCL+** 等 10 层结构，生成厚度图与偏差图。
青光眼专项分析（Hood Report）：基于哥伦比亚大学标准，分析视盘形态、RNFL/GCL 厚度，与视野计结果关联分析。
OCT 血管造影（OCT-A，选配）：非侵入式显示6×6mm/4.5×4.5mm/3×3mm范围的浅层 / 深层视网膜及脉络膜毛细血管血流。
眼前节成像（选配）：加装 HA-2 适配器，可扫描角膜、前房、虹膜、晶状体。
数据管理：支持 USB/LAN 导出、PDF 报告打印、患者数据库管理。
English
Fully Automated 3-in-1 Imaging: One-touch auto-alignment, auto-focus, and auto-capture, simultaneously acquiring OCT, color fundus, and IR fundus images.
3D Widefield Scanning: Up to 12mm×9mm scan range, covering macula and optic disc in one shot for panoramic retinal data.
Intelligent Layer Segmentation: Automatically segments 10 ｌayers (Retina, RPE, Choroid, RNFL, GCL+, etc.), generating thickness and deviation maps.
Hood Glaucoma Report: Columbia University-standard analysis of disc morphology, RNFL/GCL thickness, and correlation with visual field data.
OCT-Angiography (OCT-A, Optional): Non-invasive visualization of superficial/deep retinal and choriocapillaris flow in 6×6mm/4.5×4.5mm/3×3mm fields.
Anterior Segment Imaging (Optional): With HA-2 adapter, scans cornea, anterior chamber, iris, and lens.
Data Management: USB/LAN export, PDF reporting, patient database management.
三、产品特点（Key Features）
中文
极速全自动：5 万次 A-scan / 秒，3 秒完成单眼 3D 扫描，显著提升检查效率。
广角大视场：12mm×9mm 超广角，解决传统 OCT 视野局限问题。
多模态融合：OCT + 彩照 + OCT-A（选配），结构、形态、血流信息一体化。
高精度分层：轴向分辨率 **≤6µm**，横向分辨率 **≤20µm**，清晰显示细微病变。
小瞳孔兼容：最小φ2.5mm瞳孔即可成像，无需散瞳。
智能追踪（Follow-Up）：自动定位既往扫描位置，确保随访检查对位。
人体工学设计：10.4 英寸旋转触摸屏，无手柄，升降式颌托。
English
Ultra-Fast & Fully Automatic: 50,000 A-scans/sec, completes 3D scan per eye in 3 seconds, maximizing efficiency.
Ultra-Wide Field of View: 12mm×9mm scan eliminates traditional OCT field-of-view limitations.
Multi-Modal Fusion: OCT + Color Photo + OCT-A (optional) integrates structural, morphological, and vascular data.
High-Precision Segmentation: Axial resolution ≤6µm, lateral resolution ≤20µm, clearly visualizes subtle pathologies.
Small Pupil Capability: Operates with pupils as small as φ2.5mm, no dilation required.
Follow-Up Tracking: Automatically relocates previous scan positions for precise longitudinal monitoring.
Ergonomic Design: 10.4-inch rotatable touchscreen, lever-free operation, height-adjustable chin rest.
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）
扫描技术 谱域 OCT (SD-OCT) Scanning Technology Spectral-Domain OCT (SD-OCT)
扫描速度 50,000 A-Scans / 秒 Scan Speed 50,000 A-Scans/sec
扫描范围 3×3mm ~ 12×9mm Scan Range 3×3mm ~ 12×9mm
轴向分辨率 ≤6µm（组织内） Axial Resolution ≤6µm (in tissue)
横向分辨率 ≤20µm Lateral Resolution ≤20µm
最小瞳孔直径 φ2.5mm Min. Pupil Diameter φ2.5mm
眼底照相视角 45°（数码变焦可达 30°） Fundus Camera Angle 45° (30° with digital zoom)
工作距离 眼底：34.8mm；眼前节：62.6mm Working Distance Fundus: 34.8mm; Ant. Seg: 62.6mm
显示屏 10.4 英寸彩色触摸屏，可旋转 Display 10.4" Rotatable Color Touchscreen
数据接口 USB、LAN、RS-232C Interfaces USB, LAN, RS-232C
电源 AC 100–240V, 50/60Hz, 150VA Power Supply AC 100–240V, 50/60Hz, 150VA
尺寸 (W×D×H) 480×560×520mm Dimensions 480×560×520mm
重量 约 45kg Weight Approx. 45kg
产品分类 Ⅱa 类医疗器械 Classification Class IIa Medical Device
五、使用方法（Usage Method）
中文
开机准备
连接电源，依次开启主机、工作站、打印机。
设备自检，预热 10 分钟；清洁颌托、额托。
启动 IMAGEnet 6 软件，新建患者档案。
患者就位
患者坐正，下颌置颌托、前额贴紧，注视固视标。
调整座椅与颌托高度，使眼位对准光路中心。
自动扫描
触摸屏点击 “Capture”，设备自动对齐、对焦、扫描。
选择扫描模式：黄斑 3D、视盘 3D、广角 12×9mm、青光眼 Hood、OCT-A（选配）。
图像分析
软件自动分层，生成厚度图、偏差图、趋势分析。
手动修正分层误差，添加测量标记（如黄斑裂孔直径）。
报告与结束
生成中英文报告，保存、打印或导出至 EMR。
消毒接触部件，关机，覆盖防尘罩。
English
Preparation
Connect power, turn on main unit, workstation, and printer.
Perｆorm self-test, warm up 10 min; clean chin/forehead rest.
Launch IMAGEnet 6 software, create patient profile.
Patient Setup
Seat patient, chin on rest, forehead firm; fixate on internal target.
Adjust chair and chin rest to align eyes with optical axis.
Auto Scanning
Tap “Capture” on screen; device perｆorms auto-align, auto-focus, auto-scan.
Select scan protocol: Macula 3D, Disc 3D, Widefield 12×9mm, Hood Glaucoma, OCT-A (optional).
Image Analysis
Software auto-segments ｌayers, generates thickness, deviation, and trend maps.
Manually correct segmentation errors, place calipers (e.g., macular hole size).
Report & Finish
Generate bilingual report, save, print, or export to EMR.
Disinfect contact parts, power off, cover with dust shield.
六、适应症（Indications）
中文
黄斑疾病：黄斑裂孔、黄斑前膜、黄斑水肿、年龄相关性黄斑变性（AMD）、黄斑营养不良。
视网膜疾病：糖尿病视网膜病变、视网膜脱离、视网膜色素变性、玻璃体视网膜牵拉。
青光眼：视神经纤维层（RNFL）、神经节细胞复合体（GCL+）分析、视盘形态评估。
视神经疾病：视神经炎、视神经萎缩、视乳头水肿。
角膜及眼前节：角膜厚度、角膜地形图、前房深度、房角、人工晶体位置（需选配适配器）。
屈光手术 / 白内障：术前术后视网膜、角膜、视神经评估。
English
Macular Diseases: Macular hole, epiretinal membrane, macular edema, age-related macular degeneration (AMD), macular dystrophy.
Retinal Diseases: Diabetic retinopathy, retinal detachment, retinitis pigmentosa, vitreoretinal traction.
Glaucoma: RNFL, GCL+ analysis, optic disc morphology assessment.
Optic Nerve Disorders: Optic neuritis, optic atrophy, papilledema.
Cornea & Anterior Segment: Corneal thickness, topography, anterior chamber depth, angle, IOL position (adapter required).
Refractive / Cataract Surgery: Pre- and post-op evaluation of retina, cornea, and optic nerve.
七、禁忌症（Contraindications）
中文
光敏性癫痫患者：检查光源可能诱发癫痫发作。
近期光动力治疗（PDT）后：强光照射可能加重视网膜损伤。
无法固视 / 配合者：严重眼球震颤、意识障碍、极度不配合的儿童。
急性眼部炎症 / 感染：结膜炎、角膜炎、眼内炎急性期。
角膜严重混浊 / 血染：光线无法穿透，无法获得有效图像。
English
Patients with Photosensitive Epilepsy: Examination light may trigger seizures.
Post-Photodynamic Therapy (PDT): Intense light may exacerbate retinal damage.
Inability to Fixate/Cooperate: Severe nystagmus, cognitive impairment, uncooperative children.
Acute Ocular Inflammation/Infection: Active conjunctivitis, keratitis, endophthalmitis.
Severe Corneal Opacity/Hyphema: Light cannot penetrate; no valid image obtainable.
八、注意事项（Precautions）
中文
患者安全
散瞳患者检查后避免强光直射，告知视物模糊暂时性。
老年人、儿童需专人协助固定头部。
光敏患者缩短检查时间，必要时终止。
设备维护
光学部件用专用拭镜纸清洁，严禁触碰镜头。
颌托、额托每次使用后用 75% 酒精消毒。
避免设备震动、碰撞，定期进行系统校准。
环境要求
温度：18–26℃，湿度：30%–65%，无粉尘、无强电磁干扰。
检查需在暗室进行，以提高图像对比度。
数据管理
定期备份患者数据，防止丢失。
禁止修改原始扫描数据与图像。
English
Patient Safety
Advise dilated patients to avoid bright light; blurred vision is temporary.
Assist elderly/children with head fixation.
Shorten exam for photosensitive patients; stop if necessary.
Device Maintenance
Clean optics with lens paper only; never touch lenses.
Disinfect chin/forehead rest with 75% alcohol after each use.
Avoid vibration/shock; perｆorm regular system calibration.
Environment
Temp: 18–26°C, RH: 30%–65%, dust-free, EMI-free environment.
Perｆorm exams in dark room for optimal image contrast.
Data Management
Back up patient data regularly to prevent loss.
Do not modify raw scan data or 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
环境：通风干燥、防尘、防潮、防腐蚀、防阳光直射、防强电磁干扰。
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：存放于强酸、强碱、有机溶剂、热源附近。
English
Temperature: -10°C to +40°C
Relative Humidity: 10% to 90% (non-condensing)
Atmospheric Pressure: 86kPa to 106kPa
Environment: Well-ventilated, dry, dust-proof, moisture-proof, corrosion-proof, away from direct sunlight and strong EMI.
Long-Term Storage: Power off, seal optics, secure unit, cover with dust/moisture shield.
Prohibited: Storage near strong acids, alkalis, solvents, or heat sources.
十、说明书核心信息（Key Manual Inｆormation）
中文
产品分类：Ⅱa 类医疗器械，注册证号：国械注进 XXXXXXXX。
标准认证：符合 IEC 60601-1, IEC 60601-1-2, ISO 15004 等标准。
核心组件：光学主机、10.4 英寸触摸屏、自动对焦系统、颌托系统、IMAGEnet 6 工作站。
维护周期：每日清洁表面；每周检查光学与机械系统；每年由厂家进行校准与维护。
保修：整机1 年保修，光学系统2 年保修；耗材（灯泡、触摸屏）除外。
重要警示
经培训的眼科专业人员操作。
非无菌设备，接触部件必须消毒。
禁止擅自改装、拆卸或使用非原厂配件。
检查结果仅供临床参考，需结合其他检查综合诊断。
English
Classification: Class IIa Medical Device, Reg. No.: XXXXXXXX.
Certifications: Complies with IEC 60601-1, IEC 60601-1-2, ISO 15004, etc..
Core Components: Optical main unit, 10.4" touchscreen, auto-focus system, chin rest, IMAGEnet 6 workstation.
Maintenance Schedule: Daily surface cleaning; weekly optical/mechanical check; annual factory calibration and service.
Warranty: 1-year whole unit, 2-year optical system; excludes consumables (bulb, touchscreen).
Important Warnings
For use by trained ophthalmic professionals only.
Non-sterile; disinfect contact parts.
No unauthorized modification, disassembly, or non-OEM parts.
Results are for clinical reference only; must correlate with other findings.
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：厂家拓普康OCT眼科光学相干断层扫描仪3D,OCT-1,Maestro2,拓普康OCT,拓普康光学相干断层扫描仪
