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上海康世达医疗器械有限公司 主营产品:医用体检,诊断,急救,化验,超声,医学分析,生命科学,消毒灭菌,康复治疗,手术室,急救室,诊疗室等设备,一类医疗器械,二类医疗器械,三类医疗器械,IVD及消毒器具耗材

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盛达同泽验光仪MRT 3000

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详细内容

盛达同泽验光仪MRT 3000










产品名称 验光仪

管理类别 第二类

型号规格 MRT 3000

结构及组成/主要组成成分 验光仪按外观划分由主体部、电源部和鄂托部组成;按功能系统划分由光学系统、采集控制系统和机械运动机构组成。

适用范围/预期用途 适用于测量人眼的球镜屈光度、柱镜屈光度、散光轴。

一、工作原理 Working Principle

中文

设备基于MRT 多光谱屈光地形图技术与红外客观验光原理集成设计。内部红外多光谱光源投射至受检者眼底视网膜,光线经人眼屈光介质反射后由高精度光学采集系统接收;设备内置闭环追踪控制系统实时捕捉瞳孔位置,同步采集0°~53° 全视野中央 + 周边视网膜离焦屈光数据,通过内置算法运算生成二维屈光地形图,量化输出球镜、柱镜、散光轴位、周边相对离焦等全部屈光参数,客观反映全视网膜光线分布状态,支撑近视离焦管理临床应用PMC。

English

This device integrates MRT multispectral refractive topography technology and infrared objective refraction principle. The built-in infrared multispectral light source projects light onto the subject’s fundus retina. After being reflected by the human eye’s refractive medium, the light is captured by a high-precision optical acquisition system. The closed-loop tracking control system tracks pupil position in real time, simultaneously collecting full-field central and peripheral retinal defocus refractive data covering 0°~53°. The built-in algorithm calculates and generates a 2D refractive topography map, quantitatively outputting all refractive parameters including spherical power, cylindrical power, astigmatic axis, and relative peripheral defocus. It objectively reflects the light distribution across the entire retina to support clinical myopia defocus managementthondar.co....

二、产品功能 Product Functions

中文

  1. 中央屈光检测:自动测量人眼球镜屈光度、柱镜屈光度、散光轴位、等效球镜;

  2. 全视野周边屈光测绘:覆盖 53° 视网膜广角范围,检测各象限周边相对离焦值,生成彩色屈光地形图;

  3. 自动瞳孔追踪定位:实时追踪眼球微动,自动对焦、自动锁定测量区域;

  4. 数据存储与输出:单设备存储多组患者档案,支持数据导出、打印屈光检测报告;

  5. 近视管理数据分析:量化周边远视离焦 / 近视离焦数值,评估近视进展风险;

  6. 个性化离焦镜片数据支撑:输出完整周边屈光参数,用于定制化近视防控镜片设计;

  7. 治疗效果随访对比:留存历次检测地形图,纵向对比屈光发育变化,评估防控镜片干预效果thondar.co...。

English

  1. Central Refraction Test: Automatically measure human eye spherical diopter, cylindrical diopter, astigmatic axis and spherical equivalent;

  2. Full-field Peripheral Refraction Mapping: Wide-angle retinal coverage up to 53°, detect relative peripheral defocus value of each quadrant and generate color refractive topography map;

  3. Automatic Pupil Tracking & Positioning: Track tiny eye movements in real time, auto-focus and lock measurement area automatically;

  4. Data Storage & Output: Store multiple patient records locally, support data export and printed refractive test reports;

  5. Myopia Management Data Analysis: Quantify peripheral hyperopic/myopic defocus values to assess myopia progression risk;

  6. Personalized Defocus Lens Data Support: Output complete peripheral refractive parameters for customized myopia control lens design;

  7. Follow-up Comparison of Treatment Efficacy: Archive historical topography maps for longitudinal comparison of refractive development and evaluate intervention effect of myopia control lensesthondar.co....

三、产品特点 Product Features

中文

  1. 行业独有 MRT 多光谱屈光地形图技术,区别于普通角膜地形图,直接检测视网膜离焦状态;

  2. 超大 53° 广角检测范围,一站式获取中央 + 全周边屈光数据,无需分多次定位测量;

  3. 全自动闭环瞳孔跟踪,无需人工反复调焦,2–3 秒完成单眼全视野检测,检测效率极高;

  4. 检测客观,无接触、无散瞳、无眼部刺激,儿童青少年适配性强;

  5. 检测数据重复性、一致性高,大幅降低操作人员技术水平对结果的干扰;

  6. 可视化彩色地形图直观呈现视网膜屈光分布,临床判读简单易懂;

  7. 适配全年龄段人群,可用于儿童近视筛查、青少年近视长期监测、成人屈光筛查;

  8. 整机一体化设计,集成光学系统、运动机构、触控显示屏,占用诊室空间小;

  9. 配套完整数据管理软件,支持患者档案分类管理、历次报告对比分析thondar.co...。

English

  1. Exclusive MRT multispectral refractive topography technology, different from conventional corneal topography; it directly detects retinal defocus status;

  2. Extra-wide 53° detection field, one-stop acquisition of central and full peripheral refractive data without repeated positioning measurements;

  3. Fully automatic closed-loop pupil tracking, no manual repeated focusing required. Single-eye full-field test finished within 2–3 seconds for ultra-high efficiency;

  4. Objective and non-invasive test: non-contact, no cycloplegia, no eye irritation, highly suitable for children and adolescents;

  5. High repeatability and consistency of test data, greatly reducing interference of operator proficiency on results;

  6. Visual color topography map intuitively displays retinal refractive distribution for easy clinical interpretation;

  7. Applicable to all age groups: children myopia screening, long-term adolescent myopia monitoring and adult refractive screening;

  8. Integrated all-in-one design integrating optical system, motion mechanism and touch display, occupying minimal clinic space;

  9. Matched complete data management software, supporting classified patient file management and comparative analysis of historical reportsthondar.co....

四、技术参数 Technical Specifications

中文

  1. 设备型号:MRT 3000

  2. 管理类别:第二类医疗器械

  3. 测量视野范围:视网膜 0°~53° 广角全象限覆盖

  4. 测量时间:单眼 2–3 秒完成全视野检测

  5. 球镜测量范围:-20.00D ~ +15.00D

  6. 柱镜测量范围:0.00D ~ ±6.00D

  7. 散光轴位范围:0° ~ 180°

  8. 自动追踪:实时瞳孔闭环自动跟踪、自动对焦

  9. 成像输出:彩色二维屈光地形图 + 数值化屈光参数表

  10. 数据存储:本地存储≥1000 组患者检测档案

  11. 操作界面:高清触控液晶显示屏

  12. 供电参数:AC220V 50Hz,额定功率≤120W

  13. 防护等级:I 类 B 型应用部分,IPX0

  14. 整机结构:主机光学系统、颌托升降机构、头靠支架、电源模块、控制系统PMC

English

  1. Model: MRT 3000

  2. Device Classification: Class II Medical Device

  3. Detection Field of View: Full quadrant retinal coverage 0°~53°

  4. Measurement Time: Full-field single-eye test finished within 2–3 seconds

  5. Spherical Power Measurement Range: -20.00D ~ +15.00D

  6. Cylindrical Power Measurement Range: 0.00D ~ ±6.00D

  7. Astigmatic Axis Range: 0° ~ 180°

  8. Auto Tracking: Real-time closed-loop automatic pupil tracking & auto focusing

  9. Image Output: Color 2D refractive topography map + digital refractive parameter table

  10. Data Storage: Local storage capacity ≥ 1000 groups of patient test records

  11. Operation Interface: High-definition touch LCD screen

  12. Power Supply: AC220V 50Hz, rated power ≤120W

  13. Safety Protection Class: Class I, Type B applied part, IPX0

  14. Machine Structure: Main optical system, adjustable chin rest lifting mechanism, forehead support bracket, power supply module, control system.

五、使用方法 Operation Methods

中文

(一)开机前准备

  1. 将设备放置于平整、稳固桌面,水平放置无倾斜;

  2. 连接 220V 交流电源,检查电源线、设备接口无破损;

  3. 清洁颌托、头靠支架,清除灰尘、皮屑、分泌物;

  4. 开机预热 3–5 分钟,待设备自检完成、屏幕进入主操作界面。

(二)患者就位调整

  1. 引导患者落座,下巴平稳放入颌托,额头完全贴紧头靠;

  2. 升降颌托高度,使患者外眼角与设备高度标识对齐;

  3. 告知患者双眼平视仪器内部固视标,头部全程保持静止,不眨眼、不转动眼球。

(三)自动检测流程

  1. 触控屏幕选择新建患者档案,录入姓名、年龄等基础信息;

  2. 点击「自动测量」,设备自动捕捉瞳孔、实时追踪眼球;

  3. 2–3 秒自动完成单眼全部视野屈光采集;切换另一只眼重复操作;

  4. 检测完成后屏幕自动生成屈光地形图与全套数值参数。

(四)数据保存与输出

  1. 点击「保存」归档患者本次检测全部数据;

  2. 可选择「打印报告」输出纸质检测单,或导出电子数据存档;

  3. 多次检测患者可调取历史档案,自动生成前后对比地形图。

(五)关机收尾

  1. 全部检测完成后,先关闭设备软件系统,再切断电源;

  2. 擦拭清洁颌托、头靠,盖上设备防尘罩;

  3. 整理电源线、打印耗材,保持诊室整洁。

English

(1) Pre-operation Preparation

  1. Place the device on a flat, stable horizontal desktop without tilt;

  2. Connect AC220V power supply, check power cord and device interfaces for damage;

  3. Clean chin rest and forehead support bracket to remove dust, dandruff and secretions;

  4. Power on and preheat for 3–5 minutes until self-inspection completes and main operation interface displays.

(2) Patient Position Adjustment

  1. Guide patient to sit down, place chin steadily on chin rest and press forehead fully against forehead support;

  2. Adjust chin rest height to align patient’s outer canthus with the device height marker;

  3. Instruct patient to stare straight at the internal fixation target, keep head completely still without blinking or rotating eyes during test.

(3) Automatic Test Process

  1. Tap touch screen to create new patient file and input basic information including name and age;

  2. Tap "Auto Measure", the device automatically captures pupil and tracks eye movement in real time;

  3. Full-field refractive data collection of single eye automatically completes within 2–3 seconds; repeat operation for the other eye;

  4. After test completion, refractive topography map and full set of digital parameters automatically display on screen.

(4) Data Saving & Output

  1. Tap "Save" to archive all test data of the patient;

  2. Select "Print Report" to output paper test sheet or export electronic data for archiving;

  3. For patients with multiple tests, retrieve historical files to generate comparative topography maps automatically.

(5) Shutdown Procedures

  1. After all tests finish, close device software system first then cut off power supply;

  2. Wipe and clean chin rest and forehead support, cover the device with dust cover;

  3. Organize power cord and printing consumables to keep clinic tidy.

六、适应症 Indications

中文

  1. 儿童、青少年近视筛查,检测中央屈光与周边视网膜离焦状态;

  2. 青少年近视长期随访监测,追踪屈光发育变化,评估近视进展风险;

  3. 定制化近视防控离焦镜片术前 / 验配前屈光数据采集;

  4. 配戴 OK 镜、周边离焦框架镜后的干预效果评估;

  5. 成人常规客观屈光筛查,辅助获取基础验光数据;

  6. 屈光不正人群(近视、远视、散光)全眼屈光状态评估;

  7. 临床近视管理科研数据采集,用于周边离焦相关医学研究thondar.co...。

English

  1. Myopia screening for children and adolescents, testing central refraction and peripheral retinal defocus status;

  2. Long-term follow-up monitoring of adolescent myopia, tracking refractive development changes and assessing myopia progression risk;

  3. Refractive data collection before fitting customized myopia control defocus lenses;

  4. Intervention efficacy evaluation after wearing orthokeratology lenses or peripheral defocus spectacle lenses;

  5. Routine objective refractive screening for adults to assist acquisition of basic optometry data;

  6. Comprehensive assessment of full-eye refractive status for patients with refractive errors (myopia, hyperopia, astigmatism);

  7. Clinical research data collection for myopia management, applied to medical studies related to peripheral defocusthondar.co....

七、禁忌症 Contraindications

中文

设备无绝对禁忌症,以下情况谨慎使用、禁止检测:

  1. 眼部急性严重感染、重度结膜炎、角膜溃疡、眼部化脓性炎症;

  2. 眼球外伤、角膜破损、眼球破裂、近期眼科术后未恢复创面;

  3. 严重视网膜脱离、眼底大面积出血等重度眼底病变;

  4. 患者精神躁动、重度精神疾病、无法保持头部静止配合检测;

  5. 婴幼儿年龄过小,持续哭闹、无法注视内部固视标;

  6. 角膜重度浑浊、大面积角膜瘢痕,红外光源无法正常投射眼底;

  7. 佩戴软性隐形眼镜未满 2 周、硬性 RGP/OK 镜未满 4 周(镜片干扰屈光数据,需停戴后复测)PMC。

English

No absolute contraindications for this device. Use cautiously or prohibit testing under the following conditions:

  1. Acute severe ocular infection, severe conjunctivitis, corneal ulcer, ocular purulent inflammation;

  2. Ocular trauma, corneal laceration, eyeball rupture, unhealed wound after recent ophthalmic surgery;

  3. Severe retinal detachment, massive fundus hemorrhage and other severe fundus lesions;

  4. Patients with mental agitation, severe mental illness, unable to keep head still and cooperate with testing;

  5. Infants of extremely young age, crying continuously and unable to gaze at internal fixation target;

  6. Severe corneal opacity, large-area corneal scar, infrared light cannot project onto fundus normally;

  7. Patients wearing soft contact lenses less than 2 weeks, rigid RGP/orthokeratology lenses less than 4 weeks (contact lenses interfere with refractive data; re-test after lens discontinuation).

八、注意事项 Precautions

中文

(一)检测操作注意

  1. 本设备仅输出客观验光数据,不可直接作为配镜处方,需结合综合验光、主观试戴调整度数;

  2. 儿童青少年检测建议散瞳后复测,消除调节痉挛造成的测量误差;

  3. 检测前确认患者眼部无分泌物、泪水,避免遮挡瞳孔影响追踪精度;

  4. 颌托、头靠必须定期消毒,多人检测做好一人一清洁,防止交叉感染;

  5. 设备运行中禁止触碰光学镜头、内部光源,避免镜头刮花、光路偏移;

  6. 检测过程患者头部轻微晃动时,设备会自动重新锁定瞳孔,无需人工复位。

(二)设备维护注意

  1. 设备仅可放置于干燥、避光、无尘诊室,远离空调直吹、水源、化学消毒剂;

  2. 每日开机前、关机后清洁设备外壳,镜头仅使用专用无尘镜头布擦拭;

  3. 禁止使用酒精、消毒液直接喷淋光学镜头,仅可蘸取少量清洁剂轻柔擦拭;

  4. 长期闲置设备需每周开机运行 10 分钟,防止内部光学元件受潮霉变;

  5. 供电电压需稳定,禁止与大功率设备共用同一插排,避免电压波动损坏控制系统;

  6. 设备整机质保 1 年,出现成像模糊、追踪失灵、报错停机时,立即断电停止使用,联系厂家售后检修,禁止自行拆机维修。

English

(1) Test Operation Precautions

  1. This device only outputs objective optometry data and cannot be directly used as spectacle prescription. Refraction power must be adjusted combined with comprehensive refraction and subjective lens trial;

  2. Re-test with cycloplegia recommended for children and adolescents to eliminate measurement error caused by accommodative spasm;

  3. Confirm no eye secretions or tears on patient’s eyes before test to avoid pupil occlusion reducing tracking accuracy;

  4. Disinfect chin rest and forehead support regularly. Clean thoroughly for each patient to prevent cross infection;

  5. Do not touch optical lens and internal light source during device operation to avoid lens scratch and optical path deviation;

  6. If patient’s head shakes slightly during test, the device will automatically re-lock pupil without manual reset.

(2) Equipment Maintenance Precautions

  1. Place device only in dry, light-proof and dust-free clinic; keep away from direct air conditioning wind, water source and chemical disinfectant;

  2. Clean device shell before power-on and after shutdown every day. Wipe optical lens only with special dust-free lens cloth;

  3. Do not spray alcohol or disinfectant directly on optical lens; wipe gently with a small amount of dedicated cleaner only;

  4. For long-term idle equipment, power on and run for 10 minutes weekly to prevent internal optical components from damp mildew;

  5. Stable power supply voltage required. Do not share the same power strip with high-power equipment to avoid control system damage caused by voltage fluctuation;

  6. 1-year warranty for the whole machine. Cut off power and stop use immediately in case of blurry imaging, tracking failure or error shutdown. Contact manufacturer after-sales service for maintenance; disassembly and repair by non-professionals prohibited.

九、存储条件 Storage Conditions

中文

  1. 环境温度:存储长期温度范围 5℃ ~ 40℃;运行工作温度 18℃ ~ 30℃;

  2. 相对湿度:存储环境湿度 30% ~ 75%,无凝露;

  3. 环境要求:干燥、通风、避光、无粉尘、无腐蚀性气体;

  4. 放置要求:整机水平静置存放,禁止倒置、倾斜、堆叠重物;

  5. 长期存储:设备清洁完毕,安装防尘罩,断开电源,每 7 天通电试运行 10 分钟防潮;

  6. 运输存储:运输过程做好防震泡沫包裹,避免剧烈撞击、挤压,不可露天淋雨存放。

English

  1. Ambient Temperature: Long-term storage temperature range 5℃ ~ 40℃; operating temperature 18℃ ~ 30℃;

  2. Relative Humidity: Storage environment humidity 30% ~ 75%, no condensation;

  3. Environment Requirements: Dry, ventilated, light-proof, dust-free, free of corrosive gas;

  4. Placement Requirements: Store the whole machine horizontally and statically; inversion, tilt and heavy object stacking prohibited;

  5. Long-term Storage: Clean the device thoroughly, install dust cover and cut off power supply. Power on and run for 10 minutes every 7 days to prevent dampness;

  6. Transportation Storage: Wrap with shockproof foam during transportation to avoid severe impact and extrusion; outdoor storage exposed to rain prohibited.

十、说明书核心总览 Core Manual Summary

中文

盛达同泽 MRT 3000 为二类眼科广角屈光地形图验光仪,核心依托 MRT 多光谱技术,区别传统电脑验光仪仅测中央屈光,可同步检测 0°~53° 全视野中央与周边视网膜离焦,生成可视化屈光地形图。设备全自动瞳孔追踪,检测快速,核心用于儿童青少年近视筛查、长期近视进展监测、个性化离焦防控镜片数据采集、干预效果临床评估。 整机测量参数覆盖全范围屈光不正,操作流程标准化,配套完整数据存储、打印、对比分析功能;使用时需区分客观验光数据与配镜处方,儿童建议散瞳检测,严格执行设备消毒与日常维护;存在眼部急性炎症、外伤、无法配合患者禁止检测;设备需在温湿度适宜、干燥无尘环境存储使用,出现故障禁止自行拆解维修。

English

MRT 3000 by Shengda Tongze is a Class II ophthalmic wide-angle refractive topography autorefractor. Based on core MRT multispectral technology, it differs from conventional autorefractors that only measure central refraction. It simultaneously detects central and peripheral retinal defocus across full 0°~53° field of view and generates visual refractive topography maps. The device adopts fully automatic pupil tracking for fast and non-invasive testing. Its core clinical applications include myopia screening for children and adolescents, long-term myopia progression monitoring, data collection for customized defocus myopia control lenses and clinical evaluation of intervention efficacy. The whole machine covers full-range refractive error measurement parameters with standardized operation procedures, equipped with complete functions of data storage, printing and comparative analysis. Distinguish objective optometry data from spectacle prescription during operation; cycloplegic test recommended for children. Strictly implement equipment disinfection and daily maintenance. Testing is prohibited for patients with acute ocular inflammation, trauma or poor cooperation. The device shall be stored and operated in a suitable temperature & humidity, dry and dust-free environment. Self-disassembly and maintenance are prohibited in case of equipment failure.


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