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厂商供应新视野眼科光学相干断层扫描仪EyeView
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厂商供应新视野眼科光学相干断层扫描仪EyeView
桂经理19117326863微xin同号
桂经理19117326863微xin同号
管理类别
第二类
型号规格
EyeView 8100、EyeView 820、EyeView 810
结构及组成/主要组成成分
由主机(光学部分、电源部分和颏托部分)、电源线、计算机（含显示器、键盘和鼠标）、多位插座和外控型软件组件组成。
适用范围/预期用途
用于对眼后节组织的断层成像（含血管成像OCTA），眼前节组织的断层成像。
1、工作原理 Working Principle
中文：本设备为频域光学相干断层扫描（SD‑OCT）设备，采用 840nm 近红外 SLD 宽谱光源，光源发出的光分为参考光与样品光；样品光射入人眼，经眼底各层组织反射后与参考光发生干涉，光谱探测器采集干涉光谱信号，经算法解析重建，获得视网膜、黄斑、视盘等眼部组织的高分辨断层图像，实现非接触式活体眼部组织结构成像上海新眼光...。 English：This device is a spectral‑domain optical coherence tomography (SD‑OCT) system. It adopts an 840 nm near‑infrared SLD broadband light source. The light is split into reference light and sample light. The sample light enters the human eye. After being reflected by different fundus tissue ｌayers, it interferes with the reference light. A spectral detector acquires interference spectral signals. Algorithms reconstruct high‑resolution tomographic images of retina, macula, optic disc and other ocular structures to realize non‑in‑vivo ocular tissue imagingAlibaba.co...。
2、功能 Function
中文：①获取眼底黄斑、视盘、视网膜神经纤维层断层图像；②视网膜各层自动分层、厚度测量；③黄斑地形图、神经纤维层 RNFL 厚度分析；④视盘参数测算、杯盘比分析；⑤Enface 合成成像；⑥病灶体积测量、病变进展对比分析；⑦图像存储、报告输出、数据导出，支持 PACS 对接。 English：①Acquire tomographic images of macula, optic disc and retinal nerve fiber ｌayer; ②Automatic retinal ｌayer segmentation and thickness measurement; ③Macular topography & RNFL thickness analysis; ④Optic disc parameter measurement and cup‑disc ratio analysis; ⑤Enface composite imaging; ⑥Lesion volume measurement and disease progression comparison; ⑦Image storage, report output, data export and PACS connection support。
3、产品特点 Product Features
中文：1. 非接触检查，无需眼部接触；2. 三轴动态眼追踪，可补偿眼球微动，抖动患者扫描成功率高；3. 高轴向分辨率，高清眼底断层成像；4. 多种扫描模式，支持线扫、光栅、放射状、3D 容积扫描；5. 多套智能分析模型，适配黄斑、青光眼、糖网临床评估；6. 操作自动化，瞳孔自动定位、自动对焦；7. 支持报告打印、数据联网归档。 English：1.Non‑contact and non‑in‑vive examination; 2.Three‑axis dynamic eye tracking to compensate eyeball micro‑movement, high scanning success rate for tremor patients; 3.High axial resolution for high‑definition fundus tomography; 4.Multiple scan modes: line, raster, radial and 3D volume scan; 5.Multiple intelligent analysis models for macula, glaucoma and diabetic retinopathy evaluation; 6.Automatic operation: auto‑pupil positioning and auto‑focus; 7.Report printing and network‑based data archiving supported。
4、技术参数 Technical Parameters
中文 1. 成像方式：频域光学相干断层扫描 SD‑OCT 2. 光源：840nm 超辐射发光二极管 SLD 3. 组织内轴向分辨率：≤6µm 4. 组织内横向分辨率：≤20µm 5. 扫描速度：最高 36000 次 A‑scan / 秒 6. 扫描深度：≥2.5mm 7. 扫描范围：6mm、12mm；3D 容积扫描 12×9mm 8. 屈光补偿范围：‑15D～+15D 9. 最小瞳孔直径：≥3.3mm 10. 扫描模式：线扫描、光栅扫描、圆形扫描、放射状扫描、3D 扫描 11. 输出：图像存储、报告打印、PACS 接口 12. 供电：AC100‑240V，50/60Hzsyseye-ltd...
English 1.Imaging Mode：Spectral‑Domain Optical Coherence Tomography (SD‑OCT) 2.Light Source：840 nm Superluminescent Diode (SLD) 3.Axial Resolution (in tissue)：≤6 µm 4.Transverse Resolution (in tissue)：≤20 µm 5.Scan Speed：Up to 36 000 A‑scans per second 6.Scan Depth：≥2.5 mm 7.Scan Range：6 mm,12 mm; 3D volume scan 12×9 mm 8.Refractive Compensation：‑15D ~ +15D 9.Minimum Pupil Diameter：≥3.3 mm 10.Scan Modes：Line scan, raster scan, circular scan, radial scan, 3D scan 11.Output：Image storage, report printing, PACS interface 12.Power Supply：AC100‑240V,50/60HzAlibaba.co...
5、使用方法 Operation Method
中文 1. 开机预热设备，核对患者信息录入系统； 2. 患者坐于设备前，下颌放置于颏托，额头贴紧额托，调整座椅与设备高度； 3. 嘱患者注视仪器内部固视光点； 4. 操作人员调整光学探头，设备自动识别瞳孔、自动对焦追踪； 5. 选择扫描方案（黄斑 / 视盘等），启动扫描采集断层图像； 6. 采集完成后调用软件分析模块，完成厚度测算、报告生成； 7. 保存图像，打印或导出报告，完成检查； 8. 检查结束，清洁颏托额托，待机或关机。 English 1.Power‑on and warm‑up the device, input patient inｆormation; 2.Patient sits in front of the instrument, place chin on chin rest and forehead against forehead rest, adjust chair and device height; 3.Instruct patient to watch the internal fixation light; 4.Operator adjusts optical probe; the device automatically recognizes pupil, focuses and tracks eye movement; 5.Select scan protocol (macula / optic disc etc.) and start scan to acquire tomographic images; 6.After acquisition, run software analysis module for thickness calculation and report generation; 7.Save images, print or export reports and finish examination; 8.Clean chin‑rest and forehead‑rest, standby or power‑off the unit.
6、适应症 Indications
中文：用于眼科对人眼眼底视网膜、黄斑区、视盘部位进行断层成像与测量，辅助评估：黄斑病变（黄斑水肿、黄斑裂孔、年龄相关性黄斑变性）、青光眼视神经损伤、糖尿病视网膜病变、视网膜脱离、视网膜变性等眼底疾病；用于术前评估、术后随访复查。 English：For ophthalmic tomographic imaging and measurement of human fundus retina, macula and optic disc. Assist evaluation of macular diseases (macular edema, macular hole, age‑related macular degeneration), glaucomatous optic nerve damage, diabetic retinopathy, retinal detachment, retinal degeneration and other fundus diseases; for pre‑operative assessment and post‑operative follow‑up.
7、禁忌症 Contraindications
中文：1. 眼部严重外伤、眼球破裂，禁止检查；2. 眼部急性感染、严重角膜混浊、角膜穿孔，无法获得有效光学通路；3. 患者无法配合，头部完全不能保持固定，且无辅助制动手段；4. 对设备光源严重光敏过敏患者。 English：1.Severe ocular trauma or globe rupture; 2.Acute ocular infection, severe corneal opacity or corneal perforation with no valid optical access; 3.Patient cannot cooperate and cannot keep head stable without auxiliary fixation; 4.Patients with severe photosensitivity allergy to device light source.
8、注意事项 Notes
中文 1. 设备为眼科诊断设备，仅用于成像辅助诊断，不可作为独立确诊依据，需结合临床综合判断； 2. 检查环境避免强光直射，环境光照过强会降低成像质量； 3. 颏托、额托一人一消毒，避免交叉感染； 4. 禁止直视内部光源，避免强光损伤眼睛； 5. 儿童、震颤患者尽量保证头部稳定，必要时家属协助固定； 6. 设备光学镜头禁止用手触碰，使用专用镜头纸清洁； 7. 设备出现报错、图像异常时停止使用，联系厂家售后； 8. 软件版本、参数不要随意修改，防止测量结果偏差。 English 1.This is an ophthalmic diagnostic imaging device for auxiliary diagnosis only. Diagnosis shall be made combining full clinical inｆormation instead of relying solely on OCT results. 2.Avoid strong direct ambient light, which will degrade image quality. 3.Sterilize chin‑rest and forehead‑rest for each patient to prevent cross‑infection. 4.Do not stare directly into internal light source to avoid eye injury. 5.For children or tremor patients, keep head stable with family assistance if necessary. 6.Do not touch optical lens by hand; clean only with special lens paper. 7.Stop operation upon error prompts or abnormal images and contact manufacturer service. 8.Do not arbitrarily modify software version or parameters to prevent measurement deviation.
9、存储条件 Storage Conditions
中文：环境温度：10℃～40℃；相对湿度：30%‑80%，无冷凝；大气压力：70kPa‑106kPa；存放环境通风干燥，避免阳光直射、粉尘、腐蚀性气体；设备长期闲置需断电，做好防尘防护；运输避免剧烈震动、撞击。 English：Ambient temperature:10℃～40℃; Relative humidity:30%‑80%, non‑condensing; Atmospheric pressure:70kPa‑106kPa. Store in well‑ventilated and dry environment, avoid direct sunlight, dust and corrosive gas. Power‑off for long‑term storage and apply dust‑proof protection. Avoid violent vibration and impact during transportation.
10、说明书核心信息 Core Manual Inｆormation
中文：本产品属于第二类医疗器械，由光学扫描单元、颏托额托组件、计算机主机、显示器、专用 OCT 软件组成；采用频域 OCT 技术实现眼底非接触断层成像；用于眼底黄斑、视盘、视网膜结构成像测量，辅助眼科疾病筛查、诊断、随访；必须由经培训的眼科医技人员操作；严格遵守存储、使用环境；定期设备维护校准；出现故障禁止自行拆机维修，联系厂家；成像结果仅作临床参考，不能单独作为确诊依据。 English：This is Class II medical device, composed of optical scanning unit, chin‑&‑forehead‑rest assembly, computer host, monitor and dedicated OCT software. It adopts spectral‑domain OCT technology for non‑contact fundus tomographic imaging. It is used for imaging and measurement of macula, optic disc and retina for ophthalmic screening, diagnosis and follow‑up. It shall be operated only by trained ophthalmic‑technical staff. Comply strictly with storage and operating environment requirements. Perｆorm regular maintenance and calibration. Do not disassemble the unit by yourself upon failure; contact manufacturer service. Imaging results are for clinical reference only and shall not be used as sole diagnostic evidence.
以上产品详情仅供参考，临床操作请以原厂纸质说明书为准。上海康世达医疗器械有限公司不生产医疗产品，所有产品均来自产品的生产厂家，代理商，经销商，如有侵权请联系我们，会尽快处理！The above product details are for reference only. All clinical operations shall be carried out in strict accordance with the original paper instructions for use issued by the manufacturer.
Shanghai Kangshida Medical Devices Co., Ltd. does not manufacture medical devices. All products are sourced from respective manufacturers, authorized agents and distributors.
Please contact us promptly in case of any infringement, and we will resolve the matter as soon as possible.
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