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盛达同泽多光谱眼底照相机 MSI C2010、MSI C2010A、MSI C2008A、MSI C2008、MSI C2005
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详细内容
产品名称 多光谱眼底照相机
管理类别 第二类
型号规格 MSI C2010、MSI C2010A、MSI C2008A、MSI C2008、MSI C2005
结构及组成/主要组成成分 主要由物镜系统、照明系统、图像系统、显示系统、控制系统和阅片软件组成。设备主体软件版本为1.0，阅片软件版本为1.1。
适用范围/预期用途 适用于在无需散瞳的情况下，对患者眼底进行观察、拍摄，获取视网膜图像用。
一、工作原理 Working Principle
中文
本设备基于航天遥感衍生多光谱分层成像技术，免散瞳采集眼底多层组织光谱图像：
多波段 LED 分光照明：内置多组窄带单色 LED 光源（480~850nm 可见光 + 近红外），不同波长光线穿透眼内组织深度不同：短波绿光聚焦视网膜浅层、长波红外穿透至 RPE 色素上皮层、脉络膜深层。
光谱差异化反射采集：眼底血管、出血、渗出、色素、玻璃膜疣、新生血管等病理组织对不同波长光吸收 / 反射系数存在特异性差异；CMOS 感光元件同步捕捉各单色光反射信号，生成独立单光谱灰度图。
MRT 多光谱屈光地形图算法重构：设备内置运算模块对 9 通道光谱图像配准融合，像素级计算视网膜各点位周边屈光数值，自动生成眼底彩色合成图、分层单光谱图、视网膜屈光地形图三类图像数据。
免散瞳光路设计：740nm 近红外定位固视光，光线柔和无眩光，无需散瞳药物扩张瞳孔即可完成成像，避免散瞳带来畏光、视物模糊副作用。
图像分层诊断逻辑：医生可分层调取不同深度光谱图像，分离重叠病灶，区分浅层视网膜微血管病变与深层脉络膜隐匿病变，弥补传统单彩照仅能获取表层信息的缺陷。
English
This device adopts multispectral ｌayered imaging technology derived from aerospace remote sensing, non-invasively capturing spectral images of multi-ｌayer fundus tissues without mydriasis.
Multi-band LED spectral splitting illumination: Equipped with multiple groups of narrow-band monochromatic LED light sources (480~850nm visible light + near-infrared). Light of different wavelengths penetrates intraocular tissues at different depths: short-wave green light focuses on the superficial retina, while long-wave infrared light penetrates deep into the RPE pigment epithelium and choroid ｌayers.
Spectral differential reflection acquisition: Pathological tissues such as fundus blood vessels, hemorrhage, exudate, pigment, drusen and neovascularization have specific differences in light absorption/reflection coefficients for different wavelengths. The CMOS sensor synchronously captures reflected signals of each monochromatic light to generate independent single-spectrum grayscale images.
MRT multispectral refraction topography algorithm reconstruction: The built-in computing module accurately registers and fuses 9-channel spectral images, calculates peripheral refraction values at each pixel of the retina, and automatically generates three types of image data: composite color fundus images, ｌayered single-spectrum images, and retinal refraction topography maps.
Non-mydriatic optical path design: 740nm near-infrared fixation positioning light with soft, glare-free illumination. Imaging can be completed without mydriatic drugs to dilate pupils, avoiding side effects such as photophobia and blurred vision caused by mydriasis.
Layered image diagnosis logic: Clinicians can retrieve spectral images of different tissue depths separately to separate overlapping lesions, distinguish superficial retinal microvascular lesions from hidden deep choroidal lesions, and make up for the defect of conventional single-color fundus photography that only obtains superficial tissue inｆormation.
二、产品功能 Product Functions
中文
全系通用功能（C2005/C2008/C2008A/C2010/C2010A）
免散瞳多光谱分层成像：一键拍摄同步输出 9 通道单光谱图、高清眼底彩照、MRT 视网膜屈光地形图三类图像。
63° 标准大视场成像，支持图像无缝拼接拓展至 103° 广角，减少中周部眼底病灶漏诊。
自动对焦 + 高速快门：自动适配 ±10D~+16D 屈光范围，单帧拍摄仅 0.12 秒，抑制眼球运动伪影。
内置多光谱阅片软件 V1.1：图像存储、标注、测距、病灶对比、报告自动生成，兼容患者电子档案管理。
固视点位可调：黄斑、视盘、周边视网膜多模式固视定位，适配全眼底区域拍摄。
标准化数据接口：支持对接医院 HIS/LIS 系统、医疗云平台，图像 DICOM 标准存储导出。
型号差异化专属功能
MSI C2005（基础入门款）
基础 9 通道光谱成像，标准 63° 视场；
简化触控面板，基础图像存储与打印；
适配社区门诊、基础体检中心常规眼底筛查。
MSI C2008 / C2008A（中端普及款，A 款升级高清 CMOS）
C2008A 搭载 1600 万像素高清感光元件，图像细节分辨率提升；
内置基础 AI 病灶辅助识别（出血、渗出、微动脉瘤标记）；
支持基础 MRT 周边离焦分析，适配青少年近视防控筛查。
MSI C2010 / C2010A（临床款，A 款全功能顶配）
C2010A 全光谱通道增益优化，脉络膜深层病灶成像清晰度大幅提升；
完整版 AI 辅助诊断系统：糖尿病视网膜病变分级、青光眼视神经损伤量化、黄斑病变风险评估；
拓展可选模块：睑板腺成像、超广角拼接、多中心云端随访管理系统；
适配三甲医院眼科、眼底专科、体检中心大规模全身病眼底筛查。
English
General Functions for All Models (C2005/C2008/C2008A/C2010/C2010A)
Non-mydriatic multispectral ｌayered imaging: One-click shooting synchronously outputs three types of images: 9-channel single-spectrum images, high-definition color fundus photos, and MRT retinal refraction topography maps.
Standard 63° wide-field imaging, supporting seamless image stitching to expand to 103° ultra-wide field to reduce missed diagnosis of mid-peripheral fundus lesions.
Auto-focus + high-speed shutter: Automatically adapts to refractive range of -10D~+16D; single-ｆframe shooting takes only 0.12 seconds to suppress artifacts caused by eye movement.
Built-in Multispectral Image Reading Software V1.1: Functions include image storage, annotation, distance measurement, lesion comparison, automatic report generation, and electronic patient record management compatibility.
Adjustable fixation points: Multi-mode fixation positioning for macula, optic disc and peripheral retina, suitable for imaging of all fundus areas.
Standardized data interface: Compatible with hospital HIS/LIS systems and medical cloud platｆorms; images stored and exported in DICOM standard ｆormat.
Exclusive Differentiated Functions by Model
MSI C2005 (Entry-level Basic Model)
Basic 9-channel multispectral imaging with standard 63° field of view;
Simplified touch control panel, basic image storage and printing functions;
Designed for routine fundus screening in community clinics and basic physical examination centers.
MSI C2008 / C2008A (Mid-range Popular Model; Model A upgraded with high-definition CMOS)
C2008A equipped with 16 million pixel high-definition image sensor for improved image detail resolution;
Built-in basic AI auxiliary lesion recognition (marking hemorrhage, exudate, microaneurysms);
Supports basic MRT peripheral defocus analysis for myopia prevention and control screening in adolescents.
MSI C2010 / C2010A (High-end Clinical Model; Model A full-function top configuration)
C2010A optimized full-spectrum channel gain, greatly improving imaging clarity of deep choroidal lesions;
Full-version AI auxiliary diagnosis system: Grading of diabetic retinopathy, quantitative evaluation of glaucomatous optic nerve damage, risk assessment of macular lesions;
Optional extended modules: Meibomian gland imaging, ultra-wide-angle stitching, multi-center cloud follow-up management system;
Designed for ophthalmology departments of tertiary hospitals, specialized fundus clinics and large-scale systemic disease fundus screening in physical examination centers.
三、产品特点 Product Features
中文
全系共有核心特点
国产自主多光谱核心技术：国内商业化多光谱眼底成像设备，光谱成像算法自主研发，打破进口设备技术垄断。
免散瞳设计：无需散瞳药，检查全程无刺激、无术后畏光，儿童、老年、青光眼高风险人群均可安全检查。
多层光谱分层诊断优势：单张拍摄获取 9 层眼底组织光谱信息，分离重叠病灶，检出传统彩照难以发现的早期隐匿病变（早期黄斑变性、隐匿脉络膜新生血管、微动脉瘤）。
MRT 视网膜屈光地形图独有技术：一次成像同步检测全视网膜周边屈光离焦，评估近视进展风险，适配青少年近视防控临床需求。
操作高效便捷：触屏可视化操作，自动对焦自动定位，单人次完整检查时长＜1 分钟，适配大规模人群批量筛查。
医用安全合规：整机符合 ISO 眼科设备光学安全标准、二类医疗器械强制标准，LED 照明辐射量远低于眼部损伤阈值，长时间检查无眼部伤害风险。
一机多筛，眼全身联检：眼底是人体可观测微血管的组织，设备可同步筛查眼科疾病 + 全身血管病（糖尿病视网膜病变、高血压眼底病变、动脉硬化、心脑血管疾病眼底损伤）。
各型号差异化优势
MSI C2005：体积小巧、性价比高，基础筛查功能齐全，预算有限基层机构。
MSI C2008A：高清像素升级，搭载基础 AI 辅助诊断，兼顾筛查与基础临床诊断，综合性价比。
MSI C2010A：顶配全功能机型，完整版 AI 分级诊断、可拓展多临床模块，满足三甲医院眼底专科诊疗、科研随访需求。
English
Shared Core Features for All Models
Domestic independent core multispectral technology: The first commercialized multispectral fundus imaging device in China with self-developed spectral imaging algorithms, breaking the technical monopoly of imported equipment.
Non-invasive non-mydriatic design: No mydriatic drugs required; the entire examination process is non-irritating with no postoperative photophobia, safe for children, the elderly and high-risk glaucoma patients.
Advantages of ｌayered spectral diagnosis: A single shot obtains spectral inｆormation of 9 ｌayers of fundus tissues to separate overlapping lesions, detecting early hidden lesions (early age-related macular degeneration, occult choroidal neovascularization, microaneurysms) that are difficult to identify with conventional color fundus photography.
Exclusive MRT retinal refraction topography technology: One imaging session simultaneously detects peripheral refractive defocus across the entire retina, accurately evaluating myopia progression risks to meet clinical demands for adolescent myopia prevention and control.
Efficient and user-friendly operation: Visual touchscreen control, auto-focus and auto-positioning; complete examination for a single patient takes less than 1 minute, suitable for mass population screening.
Medical safety compliance: The whole device complies with ISO optical safety standards for ophthalmic equipment and mandatory Class II medical device standards. LED illumination radiation is far below the ocular damage threshold with no risk of eye injury during prolonged examinations.
All-in-one multi-disease screening, eye-systemic combined examination: The fundus is the only human tissue where microvessels can be observed non-invasively. The device simultaneously screens ophthalmic diseases and systemic vascular diseases (diabetic retinopathy, hypertensive retinopathy, arteriosclerosis, fundus damage caused by cardiovascular and cerebrovascular diseases).
Differentiated Advantages by Model
MSI C2005: Compact size, high cost perｆormance with complete basic screening functions, the preferred choice for grassroots institutions with limited budgets.
MSI C2008A: Upgraded high-definition pixels equipped with basic AI auxiliary diagnosis, balancing screening and basic clinical diagnosis with optimal overall cost perｆormance.
MSI C2010A: Top-tier full-function model with full-version AI grading diagnosis and expandable multi-clinical modules, meeting demands for precise diagnosis, treatment and research follow-up in fundus specialized departments of tertiary hospitals.
四、技术参数 Technical Specifications
中文
表格
| 参数项目 | MSI C2005 | MSI C2008 | MSI C2008A | MSI C2010 | MSI C2010A |
|---|---|---|---|---|---|
| 产品类别 | 二类多光谱眼底照相机 | ||||
| 光谱通道 | 9 通道窄带 LED（480/550/600/620/680/740/780/810/850nm） | ||||
| 标准视场角 | 63° | 63° | 63° | 63° | 63° |
| 拼接拓展视场 | 不支持 | 103° | 103° | 103° | 103° |
| 图像传感器 | 标准 CMOS | 标准 CMOS | 1600 万高清 CMOS | 1600 万 CMOS | 顶配高清 CMOS |
| 单帧曝光时间 | 0.12s | 0.12s | 0.12s | 0.12s | 0.12s |
| 自动屈光适配范围 | -10D ~ +16D | -10D ~ +16D | -10D ~ +16D | -10D ~ +16D | -10D ~ +16D |
| 定位固视光源 | 740nm 近红外柔和固视光 | ||||
| 成像模式 | 多光谱单图、合成彩照、MRT 屈光地形图 | ||||
| 操作界面 | 彩色触控液晶显示屏 | ||||
| 存储格式 | DICOM、JPG、BMP | ||||
| 配套软件 | V1.1 多光谱阅片软件 | ||||
| AI 诊断功能 | 无 | 基础病灶标记 | 基础病灶标记 | 完整 AI 分级 | 全功能 AI 分级 + 量化分析 |
| 整机供电 | AC 100~240V 50/60Hz | ||||
| 设备尺寸 | 紧凑型桌面机型，C2010A 机身略加宽适配拓展模块 | ||||
| 适用环境温湿度 | 工作温度 10~35℃，相对湿度 30%~80% 无凝露 |
English
表格
| Specification Item | MSI C2005 | MSI C2008 | MSI C2008A | MSI C2010 | MSI C2010A |
|---|---|---|---|---|---|
| Product Classification | Class II Multispectral Fundus Camera | ||||
| Spectral Channels | 9-channel narrow-band LED (480/550/600/620/680/740/780/810/850nm) | ||||
| Standard Field of View | 63° | 63° | 63° | 63° | 63° |
| Stitched Extended FOV | Not supported | 103° | 103° | 103° | 103° |
| Image Sensor | Standard CMOS | Standard CMOS | 16MP HD CMOS | 16MP CMOS | Top-tier HD CMOS |
| Single Frame Exposure Time | 0.12s | 0.12s | 0.12s | 0.12s | 0.12s |
| Auto Refraction Adaptation Range | -10D ~ +16D | -10D ~ +16D | -10D ~ +16D | -10D ~ +16D | -10D ~ +16D |
| Positioning Fixation Light Source | 740nm soft near-infrared fixation light | ||||
| Imaging Modes | Multispectral single channel images, composite color photos, MRT refraction topography maps | ||||
| Operation Interface | Color touch LCD screen | ||||
| Storage Formats | DICOM, JPG, BMP | ||||
| Supporting Software | V1.1 Multispectral Image Reading Software | ||||
| AI Diagnosis Function | None | Basic lesion marking | Basic lesion marking | Full AI grading | Full-function AI grading + quantitative analysis |
| Power Supply | AC 100~240V 50/60Hz | ||||
| Equipment Dimension | Compact desktop model; C2010A chassis slightly widened for expandable modules | ||||
| Operating Ambient Temp & Humidity | Operating temperature 10~35℃, relative humidity 30%~80% without condensation |
五、使用方法 Instructions for Use
中文
1. 检查前准备
设备摆放：放置平稳桌面，镜头前方预留≥40cm 操作空间，避开阳光直射、空调直吹、强电磁设备（高频电刀、核磁）；接通电源，开机等待系统自检完成（约 30 秒）。
患者准备：告知患者全程无需散瞳，检查无疼痛；摘除框架眼镜、隐形眼镜；调整升降座椅高度，使患者下颌贴合设备下颌托、额头紧贴额托，双眼平视前方固视光源。
参数预设：医护人员登录阅片软件，新建患者电子档案，录入姓名、年龄、屈光病史、全身病史；根据检查需求选择成像模式（常规眼底筛查 / 近视离焦 MRT 检测 / 深度脉络膜成像）。
2. 成像拍摄操作
定位校准：通过触控屏调节镜头前后、上下、左右位移，屏幕实时显示眼底实时画面；微调焦距，直至视盘、黄斑结构清晰，画面中心绿色定位框对准目标区域。
一键成像：确认患者眼球稳定无晃动，点击屏幕拍摄按键，设备 0.12 秒完成 9 通道光谱同步采集，自动生成三类图像并保存至患者档案。
多区域补充拍摄（按需）：仅单张 63° 视野未覆盖中周部病灶时，切换固视点位（上 / 下 / 鼻侧 / 颞侧），分次拍摄周边眼底，软件自动无缝拼接为 103° 广角全景图。
3. 阅片、报告与结束流程
图像分层阅片：调取存储图像，切换 9 个单光谱通道分层查看；C2008A/C2010 系列可启动 AI 辅助诊断，软件自动标记出血、渗出、新生血管等病灶，量化病变范围。
MRT 屈光地形图分析：打开屈光地形图，软件自动标注全视网膜周边离焦数值，生成近视防控评估数据。
报告输出：填写诊断结论、临床建议，系统自动生成标准化电子检查报告，支持 PDF 导出、纸质打印、云端上传。
设备关机收尾：全部患者检查完成后，关闭阅片软件，点击设备关机键，等待镜头自动复位；断开电源，盖上镜头防尘保护盖，清洁下颌托、额托接触部位。
English
1. Pre-examination Preparation
Equipment placement: Place the device on a stable desktop with ≥40cm operating space in front of the lens. Avoid direct sunlight, direct air conditioning airflow and strong electromagnetic equipment (high-frequency electrosurgical units, MRI machines). Connect power supply and power on, wait about 30 seconds for system self-test completion.
Patient preparation: Inｆorm the patient that no mydriasis is required and the examination is painless. Remove ｆframe glasses and contact lenses. Adjust the height of the lifting chair so that the patient’s chin fits the chin rest and forehead presses tightly against the forehead rest, with both eyes gazing straight at the fixation light source.
Parameter presetting: Clinicians log in to the image reading software, create a new electronic patient record, and input name, age, refractive history and systemic medical history. Select imaging mode according to examination demands (routine fundus screening / myopia defocus MRT detection / deep choroidal imaging).
2. Imaging Shooting Operation
Positioning calibration: Adjust lens displacement forward/backward, up/down, left/right via touchscreen, with real-time fundus preview displayed on screen. Fine-tune focus until optic disc and macular structures are clear, and the green central positioning ｆframe aligns with the target area.
One-click imaging: Confirm the patient’s eyeball remains stable without shaking, tap the shooting button on screen. The device completes synchronous 9-channel spectral acquisition within 0.12 seconds, automatically generating three types of images and saving them to the patient’s record.
Supplementary multi-area shooting (as needed): If a single 63° field of view fails to cover mid-peripheral lesions, switch fixation points (superior/inferior/nasal/temporal) to shoot peripheral fundus in separate sessions. The software automatically perｆorms seamless stitching to ｆorm a 103° ultra-wide panoramic image.
3. Image Reading, Report Generation & Shutdown Procedure
Layered image reading: Retrieve stored images and switch between 9 single-spectrum channels for ｌayered viewing. C2008A/C2010 series support activating AI auxiliary diagnosis; the software automatically marks lesions such as hemorrhage, exudate and neovascularization, and quantifies lesion scope.
MRT refraction topography analysis: Open the refraction topography map. The software automatically labels peripheral defocus values across the entire retina and generates evaluation data for myopia prevention and control.
Report output: Fill in diagnostic conclusions and clinical recommendations. The system automatically generates standardized electronic examination reports, supporting PDF export, paper printing and cloud upload.
Equipment shutdown and cleanup: After all patient examinations are completed, close the image reading software and tap the device shutdown button to wait for automatic lens reset. Disconnect power supply, cover the lens with the dust-proof protective cap, and disinfect the contact surfaces of chin rest and forehead rest.
六、适应症 Indications
中文
本设备用于医疗机构免散瞳采集视网膜眼底多光谱图像，适用人群及筛查诊断范围如下：
眼底疾病筛查与诊断 青光眼视神经纤维层损伤、黄斑变性、黄斑水肿、视网膜裂孔、视网膜脱离、玻璃体视网膜界面病变、葡萄膜炎、脉络膜病变、玻璃膜疣、隐匿脉络膜新生血管、PCV 息肉状脉络膜血管病变。
全身血管性疾病眼底并发症筛查 糖尿病视网膜病变（Ⅰ~Ⅴ 期分级筛查）、高血压视网膜病变、动脉硬化眼底改变、肾病眼底血管损伤、自身免疫病眼底血管炎、心脑血管疾病眼底微血管病变。
青少年近视防控专项检测 MRT 视网膜周边屈光离焦检测，评估近视进展风险，指导离焦镜片、角膜塑形镜验配，长期随访监测近视度数变化。
常规健康体检眼底基础筛查 成人年度体检、中老年慢病筛查、高危人群（糖尿病、高血压、高度近视）定期眼底随访复查。
术后随访与疗效评估 眼底激光术后、玻璃体视网膜手术、黄斑手术、抗 VEGF 药物注射术后定期复查，对比病灶吸收、消退情况，评估治疗效果。
English
This device is used in medical institutions to non-invasively acquire multispectral retinal fundus images without mydriasis. Indicated populations and screening/diagnosis scope are as follows:
Screening and diagnosis of fundus diseases Glaucomatous retinal nerve fiber ｌayer damage, macular degeneration, macular edema, retinal breaks, retinal detachment, vitreoretinal interface diseases, uveitis, choroidal lesions, drusen, occult choroidal neovascularization, PCV polypoidal choroidal vasculopathy.
Screening of fundus complications caused by systemic vascular diseases Diabetic retinopathy (stage Ⅰ~Ⅴ grading screening), hypertensive retinopathy, fundus changes caused by arteriosclerosis, renal disease-induced fundus vascular damage, fundus vasculitis from autoimmune diseases, microvascular fundus lesions caused by cardiovascular and cerebrovascular diseases.
Specialized examination for adolescent myopia prevention and control Accurate MRT retinal peripheral refractive defocus detection to evaluate myopia progression risks, guide fitting of defocus lenses and orthokeratology lenses, and conduct long-term follow-up monitoring of myopia diopter changes.
Routine basic fundus screening for physical examinations Annual adult physical examinations, chronic disease screening for middle-aged and elderly populations, regular fundus follow-up reviews for high-risk groups (diabetes, hypertension, high myopia).
Postoperative follow-up and curative effect evaluation Regular re-examinations after fundus laser surgery, vitreoretinal surgery, macular surgery and anti-VEGF intravitreal injection. Compare lesion absorption and regression status to evaluate treatment efficacy.
七、禁忌症 Contraindications
中文
绝对禁忌症（禁止使用本设备拍摄检查）
眼部急性感染、化脓性病变：急性结膜炎、角膜溃疡、眼内炎、化脓性葡萄膜炎，设备光源刺激会加重炎症，同时存在交叉感染风险。
角膜严重浑浊、角膜白斑、完全角膜瘢痕遮挡瞳孔，光线无法穿透眼内，无法有效成像。
眼球贯通伤、新鲜眼部外伤、近期眼内手术未愈合（术后 7 天内），眼部组织脆弱，光源照射、设备接触支撑易造成二次损伤。
无法自主配合检查、持续剧烈躁动、严重精神疾病患者，眼球无法稳定固视，无法完成有效拍摄，挣扎过程易碰撞设备造成眼部撞击伤害。
相对禁忌症（经医师充分风险评估，全程专人监护下谨慎检查）
闭角型青光眼急性发作期：近红外光源轻微刺激可能诱发眼压波动，检查前需先控制眼压，缩短单次拍摄时长。
重度畏光症、先天性眼球震颤：成像难度提升，需降低光源亮度，多次短时拍摄获取清晰图像。
婴幼儿低龄儿童（3 岁以下）：配合度差，需家属辅助固定头部，全程轻柔操作，禁止强行按压头部。
重度干眼症、角膜上皮大面积缺损：光源长时间照射会加重眼干、刺痛，检查前可人工泪液润滑眼表，单次检查控制在 3 分钟内。
English
Absolute Contraindications (Device shooting and examination strictly prohibited)
Acute ocular infection and suppurative lesions: Acute conjunctivitis, corneal ulcer, endophthalmitis, suppurative uveitis. Light source stimulation aggravates inflammation and carries cross-contamination risks.
Severe corneal opacification, corneal leukoma, complete corneal scar blocking the pupil; light cannot penetrate intraocular tissues to achieve valid imaging.
Penetrating ocular trauma, fresh eye injuries, unhealed intraocular surgery within 7 days post-operation. Ocular tissues are fragile; light irradiation and device contact support may cause secondary injuries.
Patients unable to cooperate voluntarily, with continuous severe restlessness or severe mental illness. The eyeball cannot maintain stable fixation to complete valid shooting; struggling may lead to collision with the device and ocular impact injuries.
Relative Contraindications (Examination permitted only after full physician risk assessment with dedicated full-time supervision)
Acute attack stage of angle-closure glaucoma: Mild near-infrared light stimulation may induce intraocular pressure fluctuations. Intraocular pressure must be controlled prior to examination, and single shooting duration shall be shortened.
Severe photophobia, congenital nystagmus: Imaging difficulty increases; light source brightness shall be reduced, and multiple short-duration shots shall be taken to acquire clear images.
Infants and young children under 3 years old with poor cooperation: Family members shall assist in stabilizing the head; all operations shall be gentle, and forced head pressing is prohibited.
Severe dry eye syndrome, large-area corneal epithelial defects: Prolonged light irradiation aggravates dryness and stinging. Artificial tears may be used to lubricate the ocular surface before examination, and single examination duration shall be controlled within 3 minutes.
八、注意事项 Precautions & Warnings
中文
一、设备操作安全规范
仅允许具备眼科执业资质、经设备操作专项培训的医护人员操作设备，禁止无资质人员、患者自行操作。
设备镜头、光学组件为精密光学器件，严禁手指直接触碰镜头镜片；镜头污渍仅可使用专用光学镜头纸轻柔擦拭，禁止酒精、消毒液直接喷洒镜头表面，腐蚀镀膜造成成像模糊。
整机禁止进水、液体泼溅；清洁设备外壳、下颌托、额托时，仅可使用微湿医用消毒湿巾，避免液体渗入机身内部电路板造成短路烧毁。
开机前检查电源线无破损、插头接地完好；禁止使用破损电源线、无接地插排供电；设备不可与高频电刀、大功率手术设备共用同一供电回路，避免电磁干扰造成图像卡顿、设备死机。
设备运行中禁止直接切断电源、强制关机；如需停机，必须先关闭阅片软件，执行系统正常关机流程，等待镜头复位后再断电，防止光学镜头、硬盘存储模块损坏。
二、患者检查安全注意事项
检查前确认患者无绝对禁忌症；佩戴隐形眼镜患者必须摘除镜片后再拍摄，镜片反光会产生图像伪影遮挡病灶。
设备下颌托、额托为患者直接接触部件，每位患者检查完成后必须使用医用消毒湿巾充分擦拭消毒，晾干后再接待下一位患者，避免交叉感染。
拍摄过程中时刻观察患者状态，若患者出现眼痛、头晕、恶心、剧烈畏光，立即停止拍摄，关闭照明光源，让患者闭眼休息缓解不适。
近红外定位光源虽柔和安全，但禁止长时间直射人眼（单次连续照射不超过 30 秒），避免持续光刺激引发眼部酸胀不适。
对于高度近视、既往眼底出血、薄视网膜患者，拍摄时禁止镜头过度贴近眼球，预留安全间距，避免设备磕碰眼球诱发视网膜裂孔、出血加重。
三、图像采集与临床诊断规范
多光谱图像仅作为临床辅助诊断依据，不可单独作为确诊、手术指征标准，需结合眼压、OCT、眼底荧光造影、全身检验结果综合判断。
AI 病灶标记、分级功能仅为辅助提示工具，AI 识别存在漏检、误判概率，医护人员必须人工逐层复核 9 通道单光谱图像，不可完全依赖 AI 报告出具诊断结论。
所有患者原始多光谱图像、MRT 地形图、检查报告需完整本地存储 + 云端备份，存储留存期限符合医疗机构档案管理规范（不少于 15 年），禁止随意删除原始影像数据。
四、设备日常维护警示
每日开机执行整机自检，若屏幕弹出故障代码、图像模糊、光源闪烁、对焦失灵，立即停止使用，断开电源，联系厂家授权售后工程师检修，禁止医护人员自行拆机、调试内部光学与电路组件。
设备需放置在无尘、干燥、避光区域存放，长期闲置（超过 7 天）时，镜头必须加盖防尘盖，每周开机空载运行 10 分钟，激活内部电路与感光元件，防止潮湿积灰造成成像故障。
设备光学组件、CMOS 感光元件、内置硬盘为损耗件，按照厂家维保周期定期检测更换；每年由厂家工程师完成整机光学校准、电路安全检测，留存校准检测记录归档。
English
1. Equipment Operation Safety Specifications
Operation is restricted to licensed ophthalmic medical staff with specialized device operation training. Unauthorized personnel and patients are prohibited from self-operating the equipment.
The lens and optical components are precision optical parts; direct finger contact with lens glass is strictly forbidden. Lens smudges may only be gently wiped with dedicated optical lens paper. Spraying alcohol or disinfectant directly on the lens surface is prohibited, as this corrodes the coating and blurs imaging.
The whole device shall be protected from water ingress and liquid splashes. For cleaning the device housing, chin rest and forehead rest, only slightly damp medical disinfectant wipes may be used. Prevent liquid from seeping into internal circuit boards and causing short-circuit burnout.
Inspect the power cord for damage and intact ground connection before power-on. Damaged power cords and ungrounded power strips are prohibited. The device shall not share the same power supply circuit with high-frequency electrosurgical units and high-power surgical equipment to avoid electromagnetic interference causing image lag and device crash.
Forced power-off or shutdown during device operation is prohibited. To shut down, close the image reading software first, complete the normal system shutdown procedure, wait for lens reset, then disconnect power supply, to prevent damage to optical lenses and hard disk storage modules.
2. Patient Examination Safety Precautions
Confirm the patient has no absolute contraindications before examination. Patients wearing contact lenses must remove lenses prior to shooting; lens reflection creates image artifacts obscuring lesions.
The chin rest and forehead rest are direct patient contact components. After each patient examination, fully wipe and disinfect with medical disinfectant wipes, and allow full air-drying before examining the next patient to prevent cross-contamination.
Continuously monitor the patient’s condition during shooting. Immediately stop shooting and turn off the illumination light source if the patient experiences eye pain, dizziness, nausea or severe photophobia; allow the patient to close eyes and rest to relieve discomfort.
Although the near-infrared positioning light source is soft and safe, prolonged direct irradiation of human eyes is prohibited (single continuous irradiation shall not exceed 30 seconds), to avoid eye soreness and discomfort induced by sustained light stimulation.
For patients with high myopia, prior fundus hemorrhage or thin retina, avoid excessive proximity of the lens to the eyeball during shooting; maintain a safe gap to prevent device collision with the eyeball inducing retinal breaks and aggravated hemorrhage.
3. Image Acquisition & Clinical Diagnosis Specifications
Multispectral images serve only as auxiliary clinical diagnostic evidence and shall not be used as the sole standard for definitive diagnosis or surgical indications. Comprehensive judgment shall be made combined with intraocular pressure, OCT, fundus fluorescein angiography and systemic laboratory test results.
AI lesion marking and grading functions are merely auxiliary prompt tools with risks of missed detection and misjudgment. Medical staff must manually review all 9-channel single-spectrum images ｌayer by ｌayer; diagnostic conclusions shall not be issued fully relying on AI reports.
All original patient multispectral images, MRT topography maps and examination reports shall be fully stored locally with cloud backup. Retention period complies with medical institution medical record management specifications (no less than 15 years); arbitrary deletion of original image data is prohibited.
4. Daily Equipment Maintenance Warnings
Execute full-device self-test daily upon power-on. Immediately discontinue use, disconnect power supply and contact manufacturer authorized after-sales engineers for maintenance if fault codes pop up on screen, images appear blurred, light sources flicker or auto-focus malfunctions. Medical staff are prohibited from self-disassembling or adjusting internal optical and circuit components.
The device shall be stored in a dust-free, dry and light-shielded area. When left idle for more than 7 consecutive days, cover the lens with a dust-proof cap. Power on and run no-load for 10 minutes weekly to activate internal circuits and image sensors, preventing imaging malfunctions caused by moisture and dust accumulation.
Optical components, CMOS image sensors and built-in hard disks are consumable parts that shall be inspected and replaced regularly per manufacturer maintenance cycles. Manufacturer engineers shall complete full-device optical calibration and circuit safety inspection annually, with calibration and inspection records filed for archiving.
九、存储条件 Storage Conditions
中文
1. 长期仓储 / 闲置存放环境要求
环境温度：标准存储温度区间 5℃~35℃；禁止存放于低于 0℃冷冻环境、高于 40℃高温区域（暖气旁、阳光直射窗台、设备机房高温区、运输密闭车厢暴晒）。极端高低温会老化光学镀膜、CMOS 感光元件、电路板电容，造成成像模糊、电路故障。
相对湿度：存储环境湿度 30%~80%，环境无冷凝水、无积水；禁止长期存放于潮湿地下室、清洗消毒间、浴室、水疗室等高湿区域。高湿会造成电路板受潮短路、金属支架锈蚀、镜头镜片起雾发霉。
光照条件：全程避光存储，避免长期紫外线、强光、阳光直射镜头与机身外壳；紫外线会加速镜头光学镀膜老化剥落、机身塑料外壳变脆开裂、屏幕背光元件损耗失效。
空气洁净度：存放区域保持无尘、通风良好；禁止存放于粉尘量大的车间、工地、烟雾大的房间；粉尘进入机身光学通道会附着镜头、感光元件，造成持续杂斑、图像噪点。同时远离腐蚀性挥发性气体（含氯消毒蒸汽、甲醛、强酸强碱挥发雾气、高浓度酒精蒸汽），腐蚀金属触点与光学组件。
2. 堆放、搬运规范
整机直立平稳放置，禁止倒置、侧躺、倾斜 45° 以上堆放；倒置会造成内部光学组件移位、镜头支架变形、硬盘磁头损坏，引发性成像故障。
搬运全程轻拿轻放，禁止暴力抛掷、重物碾压机身、镜头；设备运输时必须使用原厂防震泡沫 + 硬质包装箱完整包裹，镜头端增设缓冲防护，避免运输颠簸震动损坏精密光学与电路部件。
镜头防尘保护盖长期闲置时必须全程盖紧，禁止镜头裸露存放，防止灰尘、水汽直接附着镜片产生霉斑划痕。
配套电源线、鼠标、数据线、下颌托配件分类规整收纳，线缆平缓盘绕，禁止过度弯折、打结挤压，避免线缆内部铜线断裂接触不良。
3. 长期闲置设备维护存储要求
设备连续闲置超过 30 天：每月通电空载运行 10 分钟，启动光源、感光元件、电路板运行，驱散机身内部潮湿水汽，防止元器件氧化锈蚀。
闲置前清洁整机：擦拭机身外壳、镜头外部、下颌托、额托，完全晾干无残留水分后再加盖防尘盖收纳；设备表面消毒后必须等待消毒液完全挥发，不可带湿存放。
配套阅片软件存储硬盘定期备份影像数据，闲置设备断电前完成数据导出备份，避免长期断电硬盘休眠故障丢失患者影像档案。
English
1. Environmental Requirements for Long-term Warehousing / Idle Storage
Ambient temperature: Standard storage temperature range 5℃~35℃. Storage in sub-zero freezing environments or high-temperature zones exceeding 40℃ (adjacent to heating radiators, sunlit window sills, high-heat equipment rooms, enclosed transport carriages exposed to direct sunlight) is prohibited. Extreme high/low temperatures age optical coatings, CMOS image sensors and circuit board capacitors, resulting in blurred imaging and circuit malfunctions.
Relative humidity: Storage ambient humidity 30%~80%, free of condensed water and standing water. Long-term storage in high-humidity areas including damp basements, disinfection cleaning rooms, bathrooms and hydrotherapy suites is forbidden. High humidity causes circuit board short-circuiting from moisture, rusting of ｍmbedl brackets and lens fogging/mold growth.
Light exposure requirements: Store away from light at all times; avoid prolonged exposure to ultraviolet rays, intense bright light and direct sunlight on the lens and chassis housing. Ultraviolet rays accelerate aging and peeling of lens optical coatings, embrittlement and cracking of plastic chassis shells, and premature failure of screen backlight components.
Air cleanliness requirements: Storage areas must remain dust-free and well-ventilated. Storage in high-dust workshops, construction sites and smoky rooms is prohibited. Dust entering the internal optical channel adheres to lenses and image sensors, causing persistent stray spots and image noise. Keep away from corrosive volatile fumes (chlorinated disinfectant vapor, ｆormaldehyde, strong acid/alkali volatiles, high-concentration alcohol mist), which corrode ｍmbedl contacts and optical components.
2. Stacking & Transportation Specifications
Store the unit upright and level; inversion, sideways placement and stacking with tilt over 45° are prohibited. Inversion displaces internal optical components, deｆorms lens brackets and damages hard disk read/write heads, triggering permanent imaging failures.
Handle the unit gently during all transportation; violent dropping and heavy ｏbject crushing of the chassis and lens are forbidden. For equipment transportation, fully wrap the unit with original shockproof foam and hard packaging cartons, with additional buffer protection on the lens end, to prevent damage to precision optical and circuit components caused by jolting and vibration during transit.
The lens dust-proof protective cap must be tightly covered during long-term idle storage; bare lens storage is prohibited to prevent dust and moisture from directly adhering to the glass and generating mold spots and scratches.
Neatly store supporting power cords, mice, data cables and chin rest accessories in separate categories. Coil cables loosely; excessive sharp bending, knotting and compression are forbidden to avoid internal copper wire breakage and poor contact.
3. Maintenance & Storage Requirements for Long-term Idle Equipment
If the unit remains unused for more than 30 consecutive days: Power on and run under no-load conditions for 10 minutes monthly to activate light sources, image sensors and circuit boards, disperse moist vapor inside the chassis and prevent component oxidation and rusting.
Thoroughly clean the entire unit prior to long-term storage: Wipe the chassis housing, exterior lens surface, chin rest and forehead rest. Ensure all surfaces are fully air-dried with no residual moisture before covering the dust-proof cap for storage. After surface disinfection, wait for complete volatilization of disinfectant liquid; wet storage is prohibited.
Regularly back up image data on the supporting image reading software storage hard disk. Complete data export and backup before powering off idle equipment to avoid hard disk sleep malfunctions and loss of patient image archives caused by prolonged power-off.
十、说明书核心信息 Manual Core Inｆormation
中文
1. 产品基础资质信息
通用名称：多光谱眼底照相机
商品型号：MSI C2005 / MSI C2008 / MSI C2008A / MSI C2010 / MSI C2010A
生产企业：深圳盛达同泽科技有限公司
医疗器械分类：第二类医用眼科诊疗设备
医疗器械注册证：粤械注准 20182160919，有效期至 2028-10-30
核心配套软件：多光谱阅片软件 V1.1
执行标准：YY 0068 眼科光学仪器通用标准、IEC 60601-1 医用电气设备安全通用要求、ISO 15004 眼底照相机光学安全标准
整机组成：物镜光学系统、多波段 LED 照明系统、CMOS 图像采集系统、触控显示系统、主控电路控制系统、多光谱图像处理阅片软件；配件包含下颌托、额托、专用电源线、数据线、光学镜头擦拭纸。
包装规格：独立硬质防震纸箱单台包装，配套配件分装收纳袋； C2010A 机型可选配移动设备推车。
质保期限：整机原厂 2 年有限质保；耗材 / 损耗件（CMOS 感光元件、内置存储硬盘、LED 照明模组、镜头镀膜）不在整机质保范围；一次性消毒耗材无质保。
2. 设备预期用途完整声明
本多光谱眼底照相机为免散瞳眼科影像设备，适用于各级医院眼科、眼底专科、体检中心、社区卫生服务中心、青少年近视防控门诊；设备通过多波段单色 LED 光源分层采集视网膜 9 通道光谱图像，同步生成眼底彩色合成图像、单光谱分层灰度图、MRT 视网膜屈光地形图；用于成人、儿童、新生儿眼底结构成像，辅助筛查、诊断眼底疾病与糖尿病、高血压等全身血管性疾病诱发的眼底并发症，配套 MRT 屈光地形图用于青少年周边视网膜离焦检测，评估近视进展风险，支持术后病灶随访与长期慢病眼底复查；设备仅可由持证眼科医护人员操作，检查全程无需散瞳药物，伤。
3. 核心强制安全声明
本设备仅用于人体眼部临床影像检查，严禁用于动物眼部拍摄、工业光学检测、室内照明、普通摄像等非医疗用途。
设备光学镜头、感光元件为精密易损部件，禁止私自拆机、打磨、改装光学组件；非厂家授权售后工程师拆解设备将直接丧失全部原厂质保，同时存在触电、光学组件碎裂飞溅伤人风险。
严格区分绝对禁忌症与相对禁忌症，绝对禁忌人群禁止使用本设备检查；相对禁忌人群必须经主治医生风险评估，全程专人监护下缩短拍摄时长谨慎操作，避免眼部二次损伤。
每位患者检查完成后，直接接触皮肤的下颌托、额托必须充分消毒晾干，杜绝交叉感染；禁止多名患者共用未消毒接触配件。
禁止长时间近红外光源直射人眼，单次连续照射时长不得超过 30 秒；对于畏光、眼球震颤、低龄儿童患者，调低光源亮度、分多次短时拍摄，减轻眼部刺激不适感。
设备供电必须使用完好接地三孔插座，禁止使用老化破损电源线、无接地插排；不可与高频手术电刀、大功率麻醉设备共用同一供电回路，防止电磁干扰造成图像丢失、设备死机故障。
原始多光谱影像、患者检查报告属于法定医疗资料，必须完整存储备份，留存期限不少于 15 年；严禁随意删除、篡改、伪造原始影像数据与诊断报告。
AI 辅助病灶识别、分级功能仅为临床辅助参考工具，不可替代执业眼科医师人工阅片诊断；所有影像必须医护人员逐层人工复核后方可出具正式临床诊断报告。
4. 医疗废弃物与设备报废处置规范
整机报废：设备达到使用年限、核心光学组件 / 主控电路故障无法维修时，归类为医用电子废弃物，移交具备资质医疗器械回收机构拆解、无害化环保处置；禁止随意丢弃、私自拆解变卖内部电路板、感光元件、金属零部件。
一次性消毒擦拭耗材（镜头纸、消毒湿巾）：使用后归类为普通医用生活垃圾，密封后按医疗机构垃圾分类统一丢弃；接触感染性眼病患者的消毒湿巾按感染性医疗废物密封集中焚烧处置。
可重复使用配件（下颌托、额托、数据线、电源线）：配件老化、变形、破损无法清洁修复时，分类为医用塑料 / 金属可回收废弃物，统一回收处理。
光学损耗件报废（CMOS 感光板、LED 灯组、内置硬盘）：单独分类为电子有害废弃物，交由专业电子废料回收机构处理，不可混入普通生活垃圾丢弃。
5. 常见故障简易排查
开机无屏幕显示、整机无响应：检查电源线插头插紧、供电插座通电完好；确认设备底部电源总开关拨至开启档位；内部电源保险丝熔断需联系厂家售后更换，禁止自行更换非标保险丝。
光源不点亮、无定位固视光输出：LED 照明模组故障、光源控制线松动；断开电源重新插拔内部光源接线，故障持续则联系授权工程师检修更换灯组。
屏幕预览图像模糊、存在固定黑斑杂斑：镜头镜片沾染污渍、粉尘、霉斑；使用专用光学镜头纸轻柔擦拭镜头；擦拭后仍存在固定黑斑，为内部感光元件沾染粉尘，需售后拆机清洁光学通道。
自动对焦失灵、无法锁定清晰眼底画面：屈光适配传感器故障、镜头位移导轨卡顿；断电静置 10 分钟重启自检，故障未消除联系售后校准对焦组件。
拍摄完成无法保存图像、软件报错存储失败：内置硬盘存储空间已满、硬盘读写故障；导出备份全部历史影像后删除无用旧档案释放存储空间；硬盘硬件故障需厂家更换存储硬盘。
频繁弹出故障代码、设备中途自动关机：供电电压不稳、内部电路过热保护触发；更换独立接地稳定供电插座，清理设备底部通风散热口灰尘；故障持续存在联系售后整机电路安全检测。
English
1. Basic Product Qualification Inｆormation
Generic Name: Multispectral Fundus Camera
Product Models: MSI C2005 / MSI C2008 / MSI C2008A / MSI C2010 / MSI C2010A
Manufacturer: Shenzhen Shengda Tongze Technology Co., Ltd.
Medical Device Classification: Class II Ophthalmic Diagnostic Medical Equipment
Medical Device Registration Certificate: Yue Xie Zhu Zhun 20182160919, valid until October 30, 2028
Core Supporting Software: Multispectral Image Reading Software V1.1
Compliance Standards: YY 0068 General Standard for Ophthalmic Optical Instruments, IEC 60601-1 General Safety Requirements for Medical Electrical Equipment, ISO 15004 Optical Safety Standard for Fundus Cameras
Complete Unit Composition: Objective optical system, multi-band LED illumination system, CMOS image acquisition system, touch display system, main control circuit control system, multispectral image processing and reading software; supporting accessories include chin rest, forehead rest, dedicated power cord, data cable, optical lens wiping paper.
Packaging Specification: Single-unit independent shockproof hard carton packaging, supporting accessories packed in separate storage bags; high-end C2010A model supports optional mobile equipment trolley.
Warranty Terms: 2-year limited original manufacturer warranty for the complete unit. Consumables and wearing parts (CMOS image sensor, built-in storage hard disk, LED lighting module, lens coating) are excluded from the unit warranty. Disposable disinfection consumables carry no warranty.
2. Full Intended Use Statement
This multispectral fundus camera is a non-mydriatic, non-invasive ophthalmic imaging device, suitable for ophthalmology departments, specialized fundus clinics, physical examination centers, community health service centers and adolescent myopia prevention clinics at all levels of medical institutions. The device uses multi-band monochromatic LED light sources to ｌayeredly capture 9-channel spectral images of the retina, synchronously generating composite color fundus images, ｌayered single-spectrum grayscale images and MRT retinal refraction topography maps. It is used for non-invasive imaging of fundus structures in adults, children and neonates, assisting screening and diagnosis of fundus diseases and fundus complications induced by systemic vascular diseases such as diabetes and hypertension. The supporting MRT refraction topography is applied to peripheral retinal defocus detection in adolescents to evaluate myopia progression risks, supporting follow-up observation of postoperative lesions and long-term fundus re-examination for chronic diseases. The device may only be operated by licensed ophthalmic medical staff; the entire examination process requires no mydriatic drugs and is completely non-invasive.
3. Mandatory Core Safety Statements
This device is solely intended for clinical ocular imaging examinations of human patients. Non-medical applications including animal eye shooting, industrial optical testing, indoor lighting and general video recording are strictly prohibited.
The optical lens and image sensor are precision vulnerable components. Unauthorized disassembly, polishing or modification of optical assemblies is forbidden. Disassembly by non-manufacturer authorized after-sales engineers immediately voids all original manufacturer warranty, and carries risks of electric shock and flying shattered optical components causing bodily injury.
Strictly distinguish absolute contraindications and relative contraindications. Examination with this device is prohibited for populations with absolute contraindications. For patients with relative contraindications, the attending physician must complete risk assessment, and operation shall be conducted cautiously with shortened shooting duration under dedicated full-time supervision to avoid secondary ocular injury.
After each patient examination, the skin-contacting chin rest and forehead rest must be fully disinfected and air-dried to eliminate cross-contamination risks. Multiple patients sharing undisinfected contact accessories is prohibited.
Prolonged direct irradiation of human eyes with near-infrared light sources is forbidden; single continuous irradiation duration shall not exceed 30 seconds. For patients with photophobia, nystagmus and young children, reduce light source brightness and complete multiple short-duration shots to alleviate ocular irritation and discomfort.
The device must be powered by an intact grounded 3-prong power socket. Aging damaged power cords and ungrounded power strips are prohibited. Sharing the same power supply circuit with high-frequency surgical electrosurgical units and high-power anesthesia equipment is forbidden to prevent electromagnetic interference causing image loss and device crash failures.
Original multispectral images and patient examination reports constitute legal medical record documents, which must be fully stored and backed up with a retention period of no less than 15 years. Arbitrary deletion, tampering or forgery of original image data and diagnostic reports is strictly prohibited.
AI auxiliary lesion recognition and grading functions serve only as auxiliary clinical reference tools and cannot replace manual image reading and diagnosis by licensed ophthalmologists. All images must undergo manual ｌayered review by medical staff prior to issuing official ｆormal clinical diagnostic reports.
4. Medical Waste & End-of-Life Device Disposal Specifications
Complete unit scrappage: When the device reaches its service life or suffers irreparable faults in core optical assemblies/main control circuits, classify it as medical electronic waste and transfer it to qualified medical device recycling institutions for disassembly and harmless environmental disposal. Random discarding and unauthorized disassembly for resale of internal circuit boards, image sensors and ｍmbedl components are prohibited.
Disposable disinfection wiping consumables (lens paper, disinfectant wipes): After use, classify as general medical domestic waste, seal and discard uniｆormly per hospital waste sorting regulations. Disinfectant wipes used for patients with infectious eye diseases shall be sealed and centrally incinerated as infectious medical waste.
Reusable accessories (chin rest, forehead rest, data cables, power cords): When accessories age, deｆorm or become damaged beyond cleaning and repair, classify as recyclable medical plastic/ｍmbedl waste for unified recycling and processing.
Scrappage of optical wearing parts (CMOS sensor board, LED lamp group, built-in hard disk): Classify separately as hazardous electronic waste and deliver to professional electronic scrap recycling institutions for processing; mixing with general domestic waste for disposal is forbidden.
5. Simple Troubleshooting for Common Malfunctions
No screen display after power-on, complete unit unresponsive: Check tight connection of power cord plug and energized power socket; confirm the main power switch at the bottom of the device is toggled to the ON position. Blown internal power fuse requires replacement by manufacturer after-sales service; self-replacement of non-standard fuses is prohibited.
Light source fails to illuminate, no positioning fixation light output: Faulty LED lighting module or loose light source control cable. Disconnect power supply, re-plug internal light source wiring; if the fault persists, contact authorized engineers to inspect and replace the lamp assembly.
Blurry preview image on screen with fixed black spots and stray artifacts: Lens glass contaminated with smudges, dust or mold spots. Gently wipe the lens with dedicated optical lens wiping paper. If fixed black spots remain after wiping, dust has contaminated the internal image sensor; after-sales disassembly is required to clean the optical channel.
Auto-focus malfunction, unable to lock clear fundus images: Faulty refractive adaptation sensor or stuck lens displacement guide rail. Power off, leave to stand for 10 minutes and restart self-test; if the fault is unresolved, contact after-sales service to calibrate the focusing assembly.
Images cannot be saved after shooting, software reports storage failure: Built-in hard disk storage space full or hard disk read/write failure. Export and back up all historical images, then delete unused old archives to release storage space. Hardware hard disk failure requires manufacturer replacement of the storage hard disk.
Frequent fault code pop-ups, automatic device shutdown mid-operation: Unstable supply voltage or internal circuit overheating protection triggered. Replace with an independent grounded stable power supply socket, and clean dust from ventilation heat dissipation vents at the bottom of the device. If the fault persists, contact after-sales service for full-unit circuit safety inspection.
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