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厂商东京光学眼科光学相干断层扫描仪3D OCT-1 Maestro2
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厂商东京光学眼科光学相干断层扫描仪3D OCT-1 Maestro2
桂经理19117326863微xin同号
产品名称 眼科光学相干断层扫描仪
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、工作原理 / Working Principle
中文
采用频域光学相干断层扫描（SD-OCT） 原理。仪器发射低相干红外光源，通过迈克尔逊干涉仪结构，将光线分为参考光与探测光。探测光照射眼底并反射，与参考光发生干涉。高速光谱仪采集干涉信号，经计算机算法解析，实时重建出眼底（视网膜、视神经乳头）及眼前节的高分辨率二维断层与三维立体图像。内置TrueTrack™智能追踪技术，可实时锁定眼球，补偿微动，保证图像。同时集成真彩色眼底照相光路，实现 OCT 与彩照配准融合。
English
Adopts Spectral-Domain Optical Coherence Tomography (SD-OCT) principle. Emits low-coherence infrared light, split into reference and sample beams via a Michelson Interferometer. The sample beam illuminates and reflects from the retina; interference occurs with the reference beam. A high-speed spectrometer captures signals, which are analyzed by computer algorithms to reconstruct real-time, high-resolution 2D cross-sectional and 3D images of the posterior (retina, optic disc) and anterior segments. Features TrueTrack™ Smart Tracking to lock eye position, compensating for micro-saccades for precision. Integrates true-color fundus camera for PinPoint™ registration of OCT and color images.
二、产品功能 / Functions
中文
眼底断层扫描（OCT）：高清扫描视网膜各层，测量厚度、分析结构，诊断黄斑、青光眼、糖尿病视网膜病变。
OCT 血管成像（OCTA）：检测视网膜 / 脉络膜微血管血流，无需造影剂。
真彩色眼底照相：同步获取 45° 高清彩色眼底图，与 OCT 融合定位病变。
眼前节扫描（选配）：加装附件后，测量角膜厚度、前房深度、房角结构。
自动分析报告：自动分层（视网膜、RNFL、GCL）、测厚、生成青光眼 Hood 报告、与数据库对比。
全自动采集：一键自动对准、对焦、追踪、拍摄，支持手动 / 半自动模式。
数据管理：图像存储、检索、打印、USB/LAN 传输、电子对接。
English
Fundus Tomography (OCT): High-res scanning of retinal ｌayers, thickness analysis for macular, glaucoma, and diabetic retinopathy diagnosis.
OCT Angiography (OCTA): Non-invasive imaging of retinal/choroidal microvasculature without contrast.
True-Color Fundus Photography: Simultaneous 45° high-res color imaging, fused with OCT for precise lesion localization.
Anterior Segment OCT (Optional): With accessory, measures corneal thickness, anterior chamber depth, angle structures.
Automated Analysis: Auto-ｌayer segmentation (Retina, RNFL, GCL), thickness mapping, glaucoma Hood report, database comparison.
Auto-Capture: One-touch auto-alignment, focusing, tracking, and capture; manual/semi-auto modes available.
Data Management: Image storage, retrieval, printing, USB/LAN transfer, EHR integration.
三、产品特点 / Product Features
中文
频域高清（5 万 A-Scan / 秒）：速度快、分辨率高（轴向 6µm），图像清晰、伪影少。
TrueTrack™实时追踪：自动跟踪眼球，患者微动不影响成像，成功率高。
OCT + 彩照二合一：同步采集，融合，病变定位一目了然。
12mm×9mm 超广角扫描：单次覆盖黄斑 + 视盘，检查高效。
全自动操作：一键式流程，简化操作、提升效率、减少医患负担。
OCTA 血管成像：免造影、无过敏、快速观察微循环。
360° 旋转触摸屏：操作灵活、界面友好、便于观察。
前后段一体机：选配附件即可检查角膜、房角，一机多用。
English
High-Speed SD-OCT (50,000 A-Scans/sec): Fast, high-resolution (6µm axial), sharp images, minimal artifacts.
TrueTrack™ Smart Tracking: Real-time eye tracking compensates for movement, high success rate.
Dual-Modal Imaging (OCT+Fundus): Simultaneous capture, precise fusion, clear lesion localization.
12mm×9mm Widefield Scan: Single scan covers macula + disc, efficient workflow.
Full Automation: One-touch operation simplifies workflow, boosts efficiency.
OCTA (Non-Contrast): No dye, no allergy risk, fast microvascular imaging.
360° Rotating Touchscreen: Flexible, user-friendly interface.
Dual-Mode (Posterior/Anterior): Optional accessory enables corneal/angle imaging.
四、技术参数 / Technical Parameters
表格
参数项 / Item 规格 / Specification
OCT 技术 频域光学相干断层扫描 (SD-OCT)
扫描速度 50,000 A-Scans / 秒
扫描范围 3×3mm ~ 12×9mm (眼底)Topcon Healthcare
轴向分辨率 ≤6µm (组织内)
横向分辨率 ≤20µm
眼底照相 真彩色、无赤光、红外；45° 视角Topcon Healthcare
OCTA 模式 6×6mm, 4.5×4.5mm, 3×3mmTopcon Healthcare
最小瞳孔 标准：≥4.0mm；小瞳孔模式：≥3.3mm
工作距离 34.8mm (眼底)；62.6mm (眼前节)
显示屏幕 可旋转高清触摸屏
尺寸 / 重量 约 490×540×560mm / 35kg
电源 AC 100~240V, 50/60Hz
五、使用方法 / Operating Instructions
中文
准备
开机自检，启动软件；建立患者档案。
患者坐正，下颌 / 额头靠紧，注视固视标。
采集
选择模式（黄斑 / 视盘 / OCTA）；按一键自动采集。
仪器自动对准、对焦、追踪、扫描；完成后生成图像。
必要时手动微调，重新采集。
分析与保存
软件自动分层、测厚、生成报告。
核对图像，保存、打印或传输数据。
结束
清洁消毒下颌托、额托；关机、盖防尘罩。
English
Preparation
Power on, self-test, launch software; create patient profile.
Patient positioned, chin/forehead rested, fixates on internal target.
Acquisition
Select protocol (Macula/ Disc/OCTA); press One-Touch Auto-Capture.
System auto-aligns, focuses, tracks, scans; image generated.
Adjust manually if needed and re-capture.
Analysis & Save
Auto-segmentation, thickness analysis, report generation.
Review, save, print, or export data.
Completion
Disinfect chin/forehead rest; power off, cover.
六、适应症 / Indications
中文
黄斑疾病：黄斑裂孔、前膜、水肿、变性、孔源性脱离。
青光眼：视神经纤维层（RNFL）、节细胞层（GCL）分析、视盘地形图。
糖尿病视网膜病变：水肿、缺血、新生血管（OCTA）。
视网膜血管病：静脉阻塞、血管炎、毛细血管扩张。
视神经病变：视神经炎、萎缩、乳头水肿。
眼前节（选配）：角膜厚度、屈光术后、青光眼房角评估。
English
Macular Diseases: Hole, epiretinal membrane, edema, degeneration, detachment.
Glaucoma: RNFL, GCL analysis, disc topography.
Diabetic Retinopathy: Edema, ischemia, neovascularization (OCTA).
Retinal Vascular Diseases: Vein occlusion, vasculitis, telangiectasia.
Optic Nerve Disorders: Neuritis, atrophy, papilledema.
Anterior Segment (Opt.): Corneal thickness, post-refractive, angle assessment.
七、禁忌症 / Contraindications
中文
绝对禁忌
急性结膜炎、角膜炎、眼内炎等严重感染期。
眼球破裂、开放性眼外伤、大量出血。
角膜完全混浊、致密白斑、无法透光。
患者躁动、意识不清、无法固视配合。
散瞳禁忌（如闭角型青光眼）需在非散瞳下谨慎评估。
相对禁忌
瞳孔＜3.3mm（未用小瞳孔模式）。
严重白内障、玻璃体混浊、屈光间质差。
眼球震颤、固视极差。
English
Absolute Contraindications
Acute infection (conjunctivitis, keratitis, endophthalmitis).
Globe rupture, open injury, active bleeding.
Total corneal opacity, dense leukoma, no light transmission.
Uncontrollable movement, unconscious, unable to fixate.
Contraindication to dilation (e.g., angle-closure glaucoma).
Relative Contraindications
Pupil <3.3mm (without small pupil mode).
Severe cataract, vitreous opacity, poor media.
Severe nystagmus, poor fixation.
八、注意事项 / Cautions
中文
专业操作：持证医师 / 技师操作，需经专业培训。
散瞳管理：常规建议散瞳；闭角型青光眼等禁忌者严禁散瞳。
感染防控：一人一消毒下颌托、额托（75% 酒精）。
光学保护：严禁触摸镜头；用专用镜头纸清洁。
患者配合：指导固视，儿童 / 老人需辅助固定头部。
设备维护：防尘、防震、防潮；定期校准（每 6 个月）。
结果解读：OCT 为辅助诊断，需结合病史、裂隙灯、眼底镜综合判断。
English
Professional Use: Only certified ophthalmologists/technicians; trained personnel only.
Dilation Caution: Dilate routinely; NO dilation for angle-closure glaucoma.
Infection Control: Disinfect chin/forehead rest (75% alcohol) per patient.
Optical Care: No finger contact; clean only with lens paper.
Patient Cooperation: Instruct fixation; assist children/elderly.
Maintenance: Dust/shock/moisture proof; calibrate every 6 months.
Diagnosis: OCT is adjunctive; combine with history, slit lamp, fundoscopy.
九、存储条件 / Storage Conditions
中文
环境：干燥、通风、清洁室内；无腐蚀性气体、粉尘、强电磁干扰。
温度：存储 5~35℃；运输 0~40℃。
湿度：30%~75%RH，无凝露；潮湿地区用防潮箱。
放置：平稳台面，光学系统加盖防尘罩。
防护：防潮、防尘、防震、防摔；远离热源、水源。
长期存放：每月通电自检一次，保持干燥防霉变。
English
Environment: Dry, ventilated, clean room; no corrosive gas, dust, EMI.
Temperature: 5~35°C (storage), 0~40°C (transport).
Humidity: 30%~75%RH, no condensation; dry box for humid areas.
Placement: Stable surface, cover optics with dust shield.
Protection: Moisture/dust/shock/drop proof; away from heat/water.
Long-Term: Power on monthly; keep dry to prevent mold.
十、说明书核心信息 / Manual Summary
中文
3D OCT-1 Maestro2 为第二类医疗器械，采用频域 OCT 与 TrueTrack™追踪技术，集OCT、OCTA、真彩色眼底照相于一体。5 万 A-Scan / 秒高速、≤6µm超高分辨率，支持12mm 超广角与一键全自动采集。可评估视网膜、视神经、脉络膜微血管及眼前节结构，适用于黄斑病变、青光眼、糖网等眼病的早期筛查、诊断、随访。设备操作简便、安全、图像，是眼科临床重要诊断工具。专业人员操作，严格遵守适应症、禁忌症、消毒与维护规范，定期校准，确保结果准确可靠。
English
The 3D OCT-1 Maestro2 is a Class II Medical Device utilizing SD-OCT and TrueTrack™ tracking, integrating OCT, OCTA, and true-color fundus photography. It features 50,000 A-Scans/sec speed, ≤6µm ultra-high resolution, 12mm widefield scanning, and One-Touch auto-capture. It non-invasively evaluates retina, optic nerve, choroidal microvasculature, and anterior segment, ideal for screening, diagnosis, and monitoring of macular degeneration, glaucoma, and diabetic retinopathy. User-friendly, safe, non-invasive, and precise, it is an essential ophthalmic diagnostic tool. For professional use only; adhere to indications, contraindications, disinfection, maintenance, and calibration for reliable results.
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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