厂商直供Keeler睛乐直接检眼镜Jazz,Professional
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品牌名称：$brandModel.Title型号： 原产地：中国大陆 医疗器械注册号(批文)： 国械注进20162162279更新时间：2026/10/19 9:40:51
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厂商直供睛乐直接检眼镜Jazz,Professional
桂经理19117326863微xin同号
管理类别
第二类
型号规格
见附页
结构及组成/主要组成成分
由充电电池组（包括充电器）、照明光路、观察屈光镜片组、照明灯泡（氙灯灯泡、卤素灯泡或LED灯泡）、光阑和滤光片、封装外壳组成。
适用范围/预期用途
该产品主要供临床供医疗单位眼科做小视场眼底直接观察用。
一、工作原理（Working Principle）
中文直接检眼镜基于光线逆向投射与屈光补偿成像原理。仪器内置光源发出光线，经聚光镜、光阑形成平行光束，通过反射镜（45°）偏转后射入患者瞳孔，照亮眼底（视网膜、视神经等）；眼底反射光沿原光路逆向返回，穿过检眼镜观察孔与可调补偿透镜组，进入检查者眼内。补偿透镜（-25D～+40D）矫正检查者与患者屈光不正，使反射光在检查者视网膜聚焦，形成正立、约 15 倍放大的眼底实时影像。
EnglishBased on the principle of reverse light projection and refractive compensation imaging. The built-in light source emits parallel beams via condenser and aperture, deflected by a 45° mirror into the patient’s pupil to illuminate the fundus (retina, optic nerve, etc.). Reflected light from the fundus travels back through the observation aperture and adjustable lens set (-25D to +40D) into the examiner’s eye. The compensating lenses correct refractive errors, focusing light to ｆorm an erect, ~15x magnified real-time fundus image.
二、产品功能（Functions）
中文
眼底直接观察：清晰查看视网膜、视神经盘、黄斑、血管及周边眼底结构
屈光间质检查：彻照法评估角膜、晶状体、玻璃体混浊（红光反射筛查）
屈光状态评估：通过补偿镜片屈光度判断患者近视、远视、散光
多模式照明：大 / 中 / 小光斑、裂隙光、无赤光、钴蓝光、固视十字适配不同检查
滤光专项检查：无赤光强化血管 / 神经纤维观察；钴蓝光配合荧光素检查角膜损伤
青光眼筛查：评估视盘杯盘比、视神经萎缩、盘沿形态
全身病眼底筛查：糖尿病 / 高血压视网膜病变、颅内压增高（视盘水肿）
便携床旁检查：手持式设计，适配急诊、社区、病房、婴幼儿场景
English
Direct Fundus Observation: Clear view of retina, optic disc, macula, vessels and peripheral fundus
Media Clarity Check: Red reflex assessment of cornea, lens, vitreous opacities
Refractive Status Evaluation: Determine myopia, hyperopia, astigmatism via lens power
Multi-Mode Illumination: Large/medium/small spots, slit, red-free, cobalt blue, fixation cross
Filtered Exams: Red-free for vessels/nerve fibers; cobalt blue with fluorescein for corneal defects
Glaucoma Screening: Assess cup-to-disc ratio, atrophy, disc rim morphology
Systemic Disease Screening: Diabetic/hypertensive retinopathy, papilloedema (ICP)
Portable Bedside Use: Handheld design for ER, community, wards, infants
三、产品特点（Product Features）
中文
高倍正像成像：约 15 倍放大，正立影像，细节清晰，无需手持辅助透镜
超宽屈光补偿：-25D～+40D（专业型 - 45D～+44D），适配全年龄段屈光状态
多光斑滤光系统：5–6 种光斑 + 3–4 种滤光片，覆盖全眼科诊断需求
光学无眩光设计：独立光路校准，减少角膜反射，眼底成像更锐利
人体工学操控：拇指轮快速调屈光度，扳机开关控光，单手稳定操作
轻量化便携：主机约 150–200g，笔式设计，配便携夹，易携带存储
光源：LED/Xenon 光源，寿命长（LED≥5000 小时），亮度 0–100% 可调
双电源兼容：干电池（AA）/ 可充电锂电池，适配室内外全场景
专业光学质量：英国 Keeler 等品牌，非球面消色差透镜，成像无畸变
English
High-Power Erect Image: ~15x magnification, erect, sharp details, no auxiliary lens
Ultra-Wide Refractive Range: -25D to +40D (specialist -45D to +44D), fits all ages
Multi-Aperture/Filter System: 5–6 apertures + 3–4 filters for full diagnostics
Glare-Free Optics: Precise alignment reduces corneal reflection for crisp fundus views
Ergonomic Control: Thumb wheel for diopters, trigger for light, single-hand stable use
Lightweight Portable: 150–200g, pen-style with pocket clip, easy carry
Long-Life Light Source: LED/Xenon (LED ≥5000hrs), 0–100% brightness adjustable
Dual Power: AA batteries / rechargeable Li-ion, indoor/outdoor use
Professional Optics: Keeler UK, aspheric achromatic lenses, distortion-free
四、技术参数（Technical Specifications）
中文
光学系统：直接检眼镜，45° 反射镜，非球面消色差光路
放大倍率：理论 15 倍（正视眼），实际 12–18 倍
屈光补偿范围：标准型 - 25D～+40D；专业型 - 45D～+44D（1D 步进）
光斑模式：大角度、中角度、小光斑、裂隙光、固视十字
滤光片：无赤光（Green）、钴蓝光（Cobalt Blue）、中性密度、通透
光源：LED（3.6V/2.8V）、Xenon、卤素；亮度连续可调
工作距离：1–2cm（镜头贴近角膜）
视野范围：约 10°（散瞳后），单次观察 2–3 个视盘直径
供电：AA 碱性电池（2.8V）；3.6V 可充电锂电池（快充 2h）
尺寸重量：主机 φ30×180mm；约 180g（含电池）
标准认证：CE、FDA、ISO 13485、YY 0065
English
Optical System: Direct ophthalmoscope, 45° mirror, aspheric achromatic optics
Magnification: Theoretical 15x (emmetropic), actual 12–18x
Diopter Range: Standard -25D to +40D; Specialist -45D to +44D (1D steps)
Apertures: Wide, intermediate, small, slit, fixation cross
Filters: Red-free (green), cobalt blue, neutral density, clear
Light Source: LED (3.6V/2.8V), Xenon, halogen; fully dimmable
Working Distance: 1–2cm (lens near cornea)
Field of View: ~10° (dilated), 2–3 disc diameters per view
Power: 2.8V AA alkaline; 3.6V Li-ion (2hr fast charge)
Size/Weight: φ30×180mm; ~180g (with battery)
Certifications: CE, FDA, ISO 13485, YY 0065
五、使用方法（Instructions for Use）
中文
准备
暗室环境，患者坐位，双眼平视前方
开机，选中等光斑 + 通透滤光，调亮度适中
检查者调屈光补偿至 0D，矫正自身屈光不正
屈光间质检查（彻照法）
距眼 10–20cm，+8D～+10D 镜片，观察红光反射
瞳孔区橘红色反光正常；黑影提示角膜 / 晶状体 / 玻璃体混浊
眼底检查
缓慢贴近至 1–2cm，旋转补偿轮至眼底清晰
右眼查右眼（右手持镜），左眼查左眼（左手持镜）
顺序：视盘→血管→视网膜→黄斑；散瞳后查周边眼底
切换光斑 / 滤光：无赤光查血管，钴蓝光查角膜损伤
记录与结束
记录视盘形态、血管比例、黄斑反光、病变位置 / 大小 / 高度
关机，清洁光学面，放回保护盒
English
Preparation
Dark room, patient seated, eyes forward
Power on, select medium aperture + clear filter, set brightness
Set diopter to 0D, correct examiner’s refractive error
Media Check (Red Reflex)
10–20cm from eye, +8D to +10D lens, observe red reflex
Orange-red reflex normal; shadows indicate cornea/lens/vitreous opacities
Fundus Examination
Move to 1–2cm, rotate dial for sharp focus
Examine right eye (right hand), left eye (left hand)
Sequence: disc → vessels → retina → macula; dilate for periphery
Switch filters: red-free for vessels, cobalt blue for corneal defects
Documentation & Finish
Record disc, vessels, macula, lesion details
Power off, clean optics, store in case
六、适应症（Indications）
中文
眼底常规筛查：视网膜出血、渗出、微血管瘤、色素沉着
视神经疾病：视盘水肿、视神经炎、萎缩、青光眼杯盘比异常
黄斑病变：黄斑变性、裂孔、水肿、中心凹反光消失
屈光间质混浊：白内障、玻璃体混浊定位与程度评估
全身病眼底：糖尿病、高血压、动脉硬化、颅内压增高
眼外伤：视网膜震荡、出血、异物、穿孔伤筛查
婴幼儿 / 老年 / 卧床患者：床旁、急诊快速眼底检查
English
Routine fundus screening: hemorrhage, exudates, microaneurysms, pigmentation
Optic nerve disorders: papilloedema, neuritis, atrophy, abnormal C/D ratio
Macular diseases: degeneration, hole, edema, absent foveal reflex
Media opacities: cataract, vitreous opacity localization
Systemic conditions: diabetes, hypertension, atherosclerosis, ICP elevation
Ocular trauma: concussion, hemorrhage, foreign body, rupture
Infants/elderly/bedridden: bedside, ER rapid exams
七、禁忌症（Contraindications）
中文
急性闭角型青光眼、浅前房、窄房角（散瞳风险）
角膜严重混浊、水肿、穿孔、活动性溃疡（无法清晰成像）
急性结膜炎 / 角膜炎伴大量分泌物（污染光学系统）
散瞳剂过敏（禁忌散瞳检查）
眼球破裂、开放性眼外伤、眼内容物脱出（禁忌操作）
严重眼睑痉挛、无法睁眼、不配合（无法安全检查）
English
Acute angle-closure glaucoma, shallow anterior chamber, narrow angle (dilation risk)
Severe corneal opacity, edema, perforation, active ulcer (poor imaging)
Acute conjunctivitis/keratitis with discharge (contaminates optics)
Mydriatic allergy (no dilation)
Ruptured globe, open injury, intraocular content prolapse (contraindicated)
Severe blepharospasm, inability to open eye, non-cooperative (unsafe)
八、注意事项（Precautions）
中文
眼科 / 全科 / 视光专业人员操作
散瞳前评估眼压，闭角型青光眼禁用散瞳剂
亮度从低渐增，避免强光直射视网膜，控制照射时间
光学面用镜头纸 / 70% 异丙醇清洁，禁用有机溶剂
每次使用后消毒镜头与外壳，防交叉感染
避免摔落、挤压、高温高湿、强磁场，保护光学元件
长期不用取出电池，每月充电一次防漏液
婴幼儿需成人固定头部，防意外碰撞
小瞳孔观察受限，必要时散瞳（排除禁忌）
English
Only trained ophthalmic/medical/optometric professionals
Assess IOP before dilation; no mydriatics for angle-closure glaucoma
Start low brightness, limit retinal exposure time
Clean optics with lens tissue/70% isopropyl; no solvents
Disinfect lens and body after each use (cross-infection)
Avoid drop, crush, heat, humidity, strong magnetic fields
Remove battery for long storage; recharge monthly
Head stabilization for infants to prevent collision
Small pupils limit view; dilate if safe (no contraindications)
九、存储条件（Storage Conditions）
中文
温度：-10℃～+50℃
湿度：≤80% RH，无冷凝
环境：干燥、通风、清洁，远离腐蚀气体、酸碱、粉尘
放置：原装保护盒，光学面朝上，防震防压
长期存储：取出电池，密封防潮；避免阳光直射、剧烈震动
English
Temperature: -10°C to +50°C
Humidity: ≤80%RH, non-condensing
Environment: Dry, ventilated, clean; away from corrosive gases, acids, dust
Storage: Original case, lenses up, shock/pressure protected
Long-term: Remove battery, sealed dry; avoid sunlight, vibration
十、说明书核心信息（Manual Core Inｆormation）
中文
分类：二类医疗器械（国械注进）
制造商：Keeler Ltd（英国温莎）等专业品牌
标准：ISO 13485、ISO 15004、EN 60601、YY 0065
保修：2 年（光学、光源、电池、耗材除外）
维护：每日清洁；每周消毒；每年校准一次
耗材：备用灯泡、电池、镜头纸、荧光素试纸
消毒：机身 70% 酒精擦拭；光学面镜头纸清洁
处置：按电子医疗废弃物规范处理
English
Class: Class II Medical Device (NMPA)
Manufacturer: Keeler Ltd (Windsor, UK) etc.
Standards: ISO 13485, ISO 15004, EN 60601, YY 0065
Warranty: 2 years (excl. optics, bulb, battery, consumables)
Maintenance: Daily clean; weekly disinfect; annual calibration
Consumables: Replacement bulb, batteries, lens tissue, fluorescein strips
Disinfection: Body 70% alcohol wipe; optics lens tissue
Disposal: Per electronic medical waste regulations
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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