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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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厂家供应拓普康手术显微镜OMS-800

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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20152163593更新时间:2026/10/16 11:04:35

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厂家供应拓普康手术显微镜OMS-800
桂经理19117326863微xin同号


拓普康手术显微镜OMS-800

管理类别

第二类

型号规格

产品型号:OMS-800

产品规格:OMS-800 Standard,OMS-800 Pro,OMS-800 OFFISS

结构及组成/主要组成成分

产品由照明系统、电气装置、机械装置组成,各规格的结构及组成详见技术要求。标准物镜镜头:f=200、目镜12.5×、数值孔径NA:0.040、总放大率:4.2-21×、视场φ10.6-φ52.8mm、照明视野:φ58mm、光斑中心的照度调节范围:0-8000lx。

适用范围/预期用途

该产品为眼科治疗、检查、处置时使用的手术用显微镜。



一、产品工作原理(Working Principle)

中文:采用伽利略式复消色差光学系统与平行双目立体光路设计。通过高亮度卤素或LED光源(光导纤维传输),经三角度同轴照明系统(±2°、+4°)投射至手术部位,光线反射后经F=200mm防污镀膜物镜、连续变倍组件与平行双目镜筒,形成高清晰度、强立体感的放大影像。设备内置红光反射增强光路、立体调节器与双动力聚焦系统,优化白内障、玻璃体视网膜手术的术野观察;搭配OFFISS免光导玻璃体手术系统时,可通过独立前置镜实现双手操作,照明覆盖全眼野。同时集成隔热、UV、黄色滤光片,有效防护视网膜光毒性损伤。English:Adopts Galilean apochromatic optical system and parallel binocular stereoscopic light path design. High-brightness halogen or LED light source (fiber optic transmission) projects to surgical site via tri-axial coaxial illumination system (±2°, +4°). Reflected light passes through F=200mm stain-proof coated objective, continuous zoom module and parallel binocular tube to form high-definition, stereoscopic magnified images. Integrated red-reflex enhanced optics, stereo adjuster and dual-power focus system optimize visualization for cataract and vitreoretinal surgery. Equipped with OFFISS (Optical Fiber Free Intravitreal Surgery System), enables bimanual operation via independent front lens with full intraocular illumination. Built-in heat, UV and yellow filters provide comprehensive retinal photoprotection.

二、核心功能(Core Functions)

中文

连续电动变倍:4.2x–21x无级缩放,13档预设倍率(4.2/5/6/7/8/9/10/11/13/15/17/19/21x)

三角度智能照明:±2°、+4° 三向切换,增强红光反射,适配小瞳孔手术

OFFISS免光导手术(高阶版):无需眼内光导,双手操作玻切,照明覆盖周边视网膜

双动力自动聚焦:脚踏控制粗/微调焦,快速复位术野焦点

立体视觉增强:小瞳孔下自动优化立体观感,图像自然清晰

多模块扩展:支持助手镜、高清摄像、荧光造影、裂隙灯照明、Medipeg2录像系统

电磁锁定臂:300° 双节臂旋转,定位,移动顺滑

安全滤光系统:黄色/ UV /隔热滤光片,一键切换防护

English

Motorized continuous zoom: 4.2x–21x infinite scaling, 13 preset steps (4.2/5/6/7/8/9/10/11/13/15/17/19/21x)

Tri-axial intelligent illumination:±2°/+4°switching, enhanced red reflex, ideal for small pupil surgery

OFFISS bimanual vitrectomy (Premium): No intraocular light guide, full peripheral retina illumination

Dual-power auto-focus: Coarse/fine foot control, fast field refocus

Stereo enhancement: Natural stereo view optimized for small pupils

Expandable: Assistant scope, HD camera, fluorescein angiography, slit illumination, Medipeg2 recording

Electromagnetic lock arm: 300°dual-arm rotation, smooth precise positioning

Safety filter bank: One-touch yellow/UV/heat protection

三、产品特点(Key Features)

中文

全光路复消色差:色彩还原真实,边缘无畸变、色差最小

防污镀膜物镜:防水防油,可直接擦拭消毒,耐频繁清洁

三角度同轴照明:低亮度下红光反射强,减少视网膜光照损伤

OFFISS双手玻切(高阶):革命性免光导,手术更安全高效

电磁锁定平衡臂:定位、移动无漂移,操作稳定

人体工学设计:45° 双目镜,瞳距/屈光度独立可调,降低术者疲劳

紧凑型稳定底座:715×715mm,节省手术室空间

术中荧光造影:实时眼底血管成像,辅助病情判断

English

Full apochromatic optics: True color rendition, minimal distortion/aberration

Stain-proof coated objective: Water/oil repellent, disinfectable, durable cleaning

Tri-axial coaxial illumination: Strong red reflex at low light, reduced retinal exposure

OFFISS bimanual vitrectomy (Premium): Revolutionary fiber-free, safer & faster surgery

Electromagnetic counterbalance: Precise lock, drift-free movement

Ergonomic design: 45°binoculars, independent PD/diopter, reduced fatigue

Compact stable base: 715×715mm, space-saving in OR

Intraoperative FA: Real-time fundus angiography for decision support

四、技术参数(Technical Specifications)

表格

参数项(Item)中文参数(Chinese Spec)英文参数(English Spec)

光学系统伽利略式,复消色差,平行双目45°Galilean, apochromatic, parallel 45°binocular

物镜焦距F=200mm(防污镀膜)F=200mm (stain-proof coated)

目镜12.5×12.5×

总放大倍率4.2x–21x(连续/ 13档)4.2x–21x (continuous/13 steps)

视野直径φ13.8–66.3mmφ13.8–66.3mm

聚焦范围600mm600mm

照明方式三角度同轴(±2°、+4°)Tri-axial coaxial (±2°, +4°)

光源12V/100W卤素/ LED可选12V/100W halogen / optional LED

滤光片隔热、UV截止、黄色、荧光造影Heat, UV-cut, yellow, FA filters

机械臂双节臂(375mm/560mm),300° 旋转Dual arms (375mm/560mm), 300°rotation

XY平移±25mm电动/手动±25mm motorized/manual

底座尺寸715×715mm715×715mm

重量Standard: 244kg; Pro: 247kg; OFFISS: 250kgStandard: 244kg; Pro: 247kg; OFFISS: 250kg

电源AC 100–240V, 50/60Hz, 280WAC 100–240V, 50/60Hz, 280W

注册证号国械注进2018222xxxxCN Reg No. 2018222xxxx

五、使用方法(Usage Method)

中文

术前准备

推入手术室,锁定底座脚轮,接通电源

检查光源、机械臂、聚焦、变倍、脚踏功能

安装无菌保护套,覆盖非灭菌区域

参数调节

调节瞳距、目镜屈光度至双眼清晰重合

设定初始倍率(4.2x),开启基础照明

调整平衡臂,使物镜对准术野中心

术中操作

脚踏控制:变倍、聚焦、照明角度、滤光片切换

低倍定位→高倍精细操作;启用黄色滤光片护眼

OFFISS模式:安装前置镜,开启免光导照明,双手操作

荧光造影:切换滤光片,实时观察眼底血管

术后流程

关闭光源、电源,清洁光学表面(专用拭镜纸)

复位机械臂,覆盖防尘罩;记录使用日志

English

Pre-op Preparation

Move to OR, lock casters, power on

Test lamp, arm, focus, zoom, footswitch functions

Apply sterile drape to non-sterile areas

Parameter Adjustment

Set PD and eyepiece diopters for clear binocular fusion

Start at 4.2x, activate base illumination

Position arm to center objective over surgical field

Intra-op Operation

Foot control: zoom, focus, illumination angle, filter toggle

Low mag for localization→high mag for dissection; use yellow filter

OFFISS mode: attach front lens, activate fiber-free illumination, bimanual ops

Fluorescein angiography: switch filter for real-time vessel imaging

Post-op Procedure

Turn off lamp/power, clean optics (lens paper only)

Reset arm, cover dust shield; log usage




六、适应症(Indications)

中文

眼前段手术:白内障超声乳化、人工晶体植入、青光眼、角膜移植、角膜修复

玻璃体视网膜手术:玻璃体切割、黄斑前膜/裂孔、视网膜脱离、糖尿病视网膜病变

前后联合手术:白内障+玻璃体切割联合手术

眼外伤/整形:眼前段创伤修复、眼整形、泪道手术

实验眼科:小动物眼科显微手术

English

Anterior segment surgery: Cataract phaco, IOL implantation, glaucoma, corneal transplant

Vitreoretinal surgery: Vitrectomy, epiretinal membrane, macular hole, retinal detachment

Combined surgery: Combined cataract + vitrectomy

Ocular trauma/plastic: Anterior segment repair, ophthalmic plastic, lacrimal surgery

Experimental ophthalmology: Small animal ophthalmic microsurgery

七、禁忌症(Contraindications)

中文

术野严重暴露障碍(如眼球震颤、严重小眼球、眼睑挛缩)

患者无法固定体位、配合手术显微镜定位

需大范围、快速频繁切换术野的非显微手术

严重屈光介质混浊(角膜白斑、浓密白内障)致成像失效

眼部急性化脓性炎症(避免感染扩散与光学污染)

English

Severe field exposure limitation (nystagmus, severe microphthalmos, eyelid contracture)

Patient unable to maintain fixed position or cooperate

Non-microsurgery requiring rapid large field changes

Severe media opacity (corneal leukoma, dense cataract) causing imaging failure

Acute purulent ocular infection (risk of contamination spread)

八、注意事项(Precautions)

中文

安全使用

持证医师/培训人员操作;定期校准光轴与聚焦

眼科手术必须启用黄色滤光片,防视网膜光损伤

禁止直视光源;亮度逐级调节,防组织灼伤

维护保养

光学表面仅用无水乙醇+拭镜纸清洁;禁用硬物擦拭

机械臂定期润滑;电磁锁定功能每月检测

备用灯泡常备;光纤避免弯折、受压

环境与操作

手术室温度18–26℃、湿度≤65%、无强电磁干扰

移动时锁定臂防坠;使用后复位防尘

故障立即停用,联系厂家工程师

English

Safety Use

Operate only by certified surgeons; regular axis/focus calibration

Yellow filter mandatory for ophthalmic surgery to prevent photodamage

Do not stare at light source; adjust brightness gradually

Maintenance

Clean optics with ethanol + lens paper only; no hard rubbing

Arm lubrication periodic; electromagnetic lock tested monthly

Keep spare bulb; avoid fiber bending/stress

Environment & Operation

OR temp 18–26℃, humidity≤65%, no strong EMI

Lock arms when moving; reset & cover after use

Stop on malfunction; contact factory engineer

九、存储条件(Storage Conditions)

中文

温度:-10℃~+40℃;相对湿度:10%~90%(无冷凝)

大气压力:86kPa~106kPa;通风干燥、防尘、防腐蚀

长期存储:断电、光学部件密封、机械臂固定、覆盖防尘防潮罩

禁止环境:远离强酸强碱、有机溶剂、阳光直射、热源、强震动

English

Temperature: -10℃~+40℃; Relative humidity: 10%–90% (non-condensing)

Atmospheric pressure: 86kPa–106kPa; ventilated, dry, dust/corrosion-free

Long-term storage: Power off, optics sealed, arm secured, dust/moisture cover

Prohibited: Keep away from acids, solvents, direct sunlight, heat, strong vibration

十、说明书核心信息(Key Manual Information)

中文

设备分类:Ⅱ 类医疗器械,符合YY 0069、ISO 15004标准

安全等级:视网膜光毒性防护Ⅰ 级,电气安全IEC 60601-1

核心组件:光学系统、电磁平衡臂、双动力聚焦、OFFISS模块、脚踏控制器

维护周期:每日清洁光学;每月机械/电气检查;每年校准

保修:整机1年,光学组件2年;耗材(灯泡/光纤)不在保修范围

警示:非无菌提供;术前必须套无菌保护套;禁止改装/拆卸

English

Classification: Class II Medical Device, compliant with YY 0069, ISO 15004

Safety: Retinal photoprotection GradeⅠ, IEC 60601-1 certified

Core modules: Optics, electromagnetic arm, dual-power focus, OFFISS, footswitch

Maintenance: Daily optics clean; monthly mechanical/electrical check; annual calibration

Warranty: 1yr whole unit, 2yr optics; consumables (bulb/fiber) excluded

Warning: Non-sterile; sterile drape required pre-op; no modification allowed



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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