厂家璀兮逐光Tracey视觉功能分析仪iTrace
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厂家璀兮逐光Tracey视觉功能分析仪iTrace
桂经理19117326863微xin同号
视觉质量是动态现实，不单单指的是视力，应该还包括不同环境，不同距离，人眼的调节力等等。在过去，对手术眼视觉质量的提升，一直以来都缺乏有效又客观的检测方法，而现在，iTrace视功能分析仪将针对屈光质量，提供客观又有效的检查方法。
一、工作原理 Working Principle
中文采用光线追踪（Ray Tracing）技术，向眼内依次投射256 束近红外激光，追踪光束经角膜、晶状体等屈光介质到达视网膜的路径。通过分析黄斑区 256 个激光点的实际位置与理想位置偏差，计算全眼、角膜及眼内（晶状体）低阶与高阶像差。同时结合 Placido 盘技术进行角膜地形图测量，可分离角膜像差与内部像差，客观评估完整视觉通路质量。
EnglishAdopts Ray Tracing technology, sequentially projects 256 near-infrared laser beams into the eye to precisely track the path of light beams passing through refractive media such as the cornea and lens to the retina. By analyzing the deviation between the actual and ideal positions of 256 laser spots on the macula, it calculates low-order and high-order aberrations of the whole eye, cornea, and intraocular (lens). Combined with Placido disc technology for corneal topography measurement, it can separate corneal and internal aberrations to ｏbjectively evaluate the quality of the complete visual pathway.
二、产品功能 Functions
中文
五合一综合检测：自动验光、角膜地形图、自动角膜曲率测量、波前像差分析、瞳孔测量
像差测量：全眼 / 角膜 / 眼内像差分离、低阶（球镜 / 柱镜）与高阶像差（球差、彗差等）量化
视觉质量评估：视觉质量指数（QVI）、角膜性能指数（CPI）、点扩散函数（PSF）、调制传递函数（MTF）
手术规划：屈光手术、白内障手术（含多焦点 IOL）方案设计、人工晶体选型指导
术后评估：屈光术后、人工晶体植入术后视觉质量追踪与疗效分析
报告输出：视网膜点阵图、屈光地形图、像差分析图等直观临床报告
English
5-in-1 Comprehensive Examination：Auto-refraction, corneal topography, auto-keratometry, wavefront aberrometry, pupillometry
Accurate Aberration Measurement：Separation of total/corneal/intraocular aberrations, quantification of low-order (sphere/cylinder) and high-order aberrations (spherical aberration, coma, etc.)
Visual Quality Assessment：Quality of Vision Index (QVI), Corneal Perｆormance Index (CPI), Point Spread Function (PSF), Modulation Transfer Function (MTF)
Surgical Planning：Design for refractive surgery, cataract surgery (including multifocal IOL), guidance for
IOL selection
Postoperative Evaluation：Visual quality tracking and efficacy analysis after refractive surgery and IOL implantation
Report Output：Intuitive clinical reports including retinal spot diagram, refractive topography, aberration analysis chart, etc.
三、产品特点 Product Features
中文
光线追踪：非插值计算，真实还原光路，可穿透人工晶体测量
像差分离：可量化分离角膜与晶状体像差的设备，定位视觉问题根源
无需散瞳：自然瞳孔下检测，减少眼部刺激，适配儿童与敏感人群
开放视野固视：单眼 / 双眼开放视野，避免调节干扰，结果更真实
操作高效：自动 / 手动双模式，3 秒快速采集，报告即时生成
全场景适配：小 / 大 / 不规则瞳孔均可测量，支持戴镜状态检测
量化指数：QVI、CPI 0-10 分直观评分，便于医患沟通与疗效对比
English
Exclusive Ray Tracing：Non-interpolation calculation, real optical path restoration, accurate measurement through IOLs
Precise Aberration Separation：Only device to quantify and separate corneal and lens aberrations, locate root causes of vision problems
No Mydriasis Required：Detection under natural pupil, reduces eye irritation, suitable for children and sensitive 人群
Open-Field Fixation：Monocular/binocular open field, avoids accommodation interference, more authentic results
Efficient Operation：Dual auto/manual modes, 3-second rapid acquisition, instant report generation
Full-Scenario Adaptation：Accurate measurement for small/large/irregular pupils, supports measurement with spectacles
Quantitative Indices：0-10 score for QVI and CPI, facilitates doctor-patient communication and efficacy comparison
四、技术参数 Technical Specifications
中文
测量范围：球镜 ±15.00D，柱镜 ±10.00D
瞳孔测量：2.5mm–8.0mm 自适应扫描
测量精度：球镜 / 柱镜 ±0.10D
角膜测量：24 环 Placido 盘，8640 测量点，覆盖 8mm 角膜区域
曲率范围：33.75D–61.36D
激光源：785nm 近红外激光（3b 类）、655nm 可见光（3a 类）
采集模式：自动 / 手动
尺寸 / 重量：33cm×43.2cm / 12.4kg
电源：100–240V AC，50/60Hz
English
Measurement Range：Sphere ±15.00D, Cylinder ±10.00D
Pupil Measurement：2.5mm–8.0mm adaptive scan
Accuracy：Sphere/Cylinder ±0.10D
Corneal Measurement：24-ring Placido disc, 8640 measuring points, covers 8mm corneal area
Keratometry Range：33.75D–61.36D
Laser Source：785nm near-infrared (Class 3b), 655nm visible (Class 3a)
Capture Mode：Auto / Manual
Dimensions/Weight：33cm×43.2cm / 12.4kg
Power Supply：100–240V AC, 50/60Hz
五、使用方法 Operating Instructions
中文
准备：接通电源，启动设备与配套软件；患者坐正，头部靠托架，双眼与设备对齐
波前像差测量（自动模式）
嘱患者注视固视灯，调整手柄至虹膜清晰
对准四个角膜反光点中心，自动完成 2 次波前采集
查看拒绝点：0（合格）、1-9（临界）、≥10（重测）
角膜地形图测量
对准 Placido 环中央，绿圈高亮时自动采集
数据分析：软件自动生成全眼 / 角膜 / 眼内像差、视觉质量指数等报告
记录保存：导出报告，关闭设备与软件
English
Preparation：Connect power, start device and software; patient sits upright, head on rest, eyes aligned with device
Wavefront Aberration Measurement (Auto Mode)
Instruct patient to fixate on target, adjust handle until iris clear
Align center of 4 corneal reflections, auto-completes 2 wavefront captures
Check rejected points: 0 (qualified), 1-9 (critical), ≥10 (retest)
Corneal Topography Measurement
Align center of Placido ring, auto-captures when green circle highlights
Data Analysis：Software auto-generates reports for total/corneal/intraocular aberrations, QVI, etc.
Save & Exit：Export reports, shut down device and software
六、适应症 Indications
中文
屈光不正（近视、远视、散光）验光与像差分析
屈光手术（LASIK/LASEK/ 全飞秒）术前评估、方案设计、术后随访
白内障术前规划：人工晶体（单焦 / 多焦 / 散光矫正型）选型
人工晶体术后视觉质量评估（眩光、重影、视物模糊原因分析）
角膜疾病（圆锥角膜、角膜变性）筛查与形态分析
青少年近视防控：高阶像差监测与视觉质量评估
不明原因视力下降、视疲劳、眩光、重影等视觉症状病因诊断
English
Precise refraction and aberration analysis for refractive errors (myopia, hyperopia, astigmatism)
Preoperative evaluation, design, postoperative follow-up for refractive surgery (LASIK/LASEK/SMILE)
Cataract preoperative planning: IOL selection (mono/multi-focal/toric)
Visual quality evaluation after IOL implantation (analysis of glare, double vision, blurred vision)
Screening and morphological analysis for corneal diseases (keratoconus, corneal dystrophy)
Juvenile myopia control: high-order aberration monitoring and visual quality assessment
Etiological diagnosis for unexplained vision loss, asthenopia, glare, double vision
七、禁忌症 Contraindications
中文
急性眼部炎症（结膜炎、角膜炎、葡萄膜炎）活动期
严重角膜损伤、溃疡、穿孔
未控制的青光眼（高眼压、急性发作期）
严重眼内出血、视网膜脱离急性期
无法固视、配合度极差的患者（如精神障碍、严重痴呆）
对近红外激光过敏或眼部极度敏感者
English
Active acute ocular inflammation (conjunctivitis, keratitis, uveitis)
Severe corneal injury, ulcer, perforation
Uncontrolled glaucoma (high IOP, acute attack)
Severe intraocular hemorrhage, acute retinal detachment
Patients unable to fixate or with extremely poor cooperation (psychosis, severe dementia)
Hypersensitivity to near-infrared laser or extremely ocular sensitivity
八、注意事项 Precautions
中文
检测前确认眼部无急性病变，摘除隐形眼镜（软镜≥24h，硬镜≥7d）
避免强光照射、眼部疲劳后立即检测，保证瞳孔自然状态
激光为 3b 类，严禁直视激光源，操作时避免光束直射他人眼睛
儿童 / 老人需专人辅助固定头部，确保测量
多次测量结果差异大时，检查固视、瞳孔状态或眼部干扰因素
设备仅作诊断参考，临床决策需结合病史与其他检查
软件定期更新，数据及时备份，防止丢失
English
Confirm no acute ocular disease before exam, remove contact lenses (soft ≥24h, rigid ≥7d)
Avoid immediate exam after strong light exposure or eye fatigue, ensure natural pupil state
Class 3b laser: do not stare at source, avoid direct beam to others’ eyes
Children/elderly need assistance to fix head for accurate measurement
If large measurement variance, check fixation, pupil status or ocular interference
Device for diagnostic reference only; clinical decisions combine history and other exams
Regular software updates, timely data backup to prevent loss
九、存储条件 Storage Conditions
中文
环境温度：15℃–30℃
相对湿度：30%–70%（无冷凝）
大气压力：860hPa–1060hPa
存放于干燥、清洁、通风环境，远离粉尘、腐蚀性气体
避免阳光直射、高温、潮湿、震动与强磁场干扰
长期闲置：每周通电 1 次，每次 30 分钟，防潮防霉变
English
Ambient Temperature: 15℃–30℃
Relative Humidity: 30%–70% (non-condensing)
Atmospheric Pressure: 860hPa–1060hPa
Store in dry, clean, ventilated area, away from dust and corrosive gases
Avoid direct sunlight, high temperature, humidity, vibration and strong magnetic fields
Long-term idle: power on once weekly for 30 mins to prevent moisture and mold
十、说明书核心信息 Manual Core Inｆormation
中文iTrace 是基于光线追踪技术的五合一视觉质量分析系统，核心价值为分离角膜与眼内像差，为屈光手术、白内障手术提供客观量化依据。无需散瞳、开放视野、快速、报告直观，适配全年龄段与各类眼部状态。临床核心应用：手术规划、人工晶体选型、术后视觉质量评估、不明原因视觉症状诊断。设备属一类医疗器械，激光安全等级 3b/3a，需专业人员操作，定期维护校准。
EnglishiTrace is a 5-in-1 visual quality analysis system based on ray tracing technology, with core value of precisely separating corneal and intraocular aberrations, providing ｏbjective quantitative basis for refractive and cataract surgery. No mydriasis, open field, fast & accurate, intuitive reports, suitable for all ages and ocular conditions. Core clinical applications: surgical planning, IOL selection, postoperative visual quality evaluation, diagnosis of unexplained visual symptoms. Class I medical device, laser safety Class 3b/3a, operated by professionals, regular maintenance and calibration required.
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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