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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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厂家供应欧科路双目视力仪4P59850

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详细内容

厂家供应欧科路双目视力仪4P59850
桂经理19117326863微xin同号

管理类别

第二类

型号规格

59850

结构及组成/主要组成成分

该产品由主机、手持式控制器和电源线组成。

适用范围/预期用途

该产品用于测试人眼视敏度、视力和色觉缺陷。

一、工作原理 (Working Principle)

中文采用静态自动视野检查法(Static Automated Perimetry),核心为LED 点阵投射或高亮度 LCD 显示技术。

设备半球形碗内(Easyfield/Smartfield)以固定 LED 或 LCD 屏幕,按预设程序投射不同亮度、大小、位置的视标。

患者单眼注视中心固视点,当感知视标时按下应答器。

系统通过4-2 阶梯法或SPARK 智能算法测定各点位光敏感度阈值,自动绘制视野灰度图与缺损图谱。

全程实时追踪眼球运动,排除伪迹,确保数据可靠。

EnglishAdopts Static Automated Perimetry, core technology is LED array projection or high-brightness LCD display.

Fixed LEDs or LCD screen inside the hemispherical bowl (Easyfield/Smartfield) project stimuli of varying brightness, size, and position per program.

Patient fixates central target with one eye, presses response button when seeing stimulus.

System determines light sensitivity threshold via 4-2 staircase or SPARK algorithm, maps visual field defects.

Real-time eye movement tracking eliminates artifacts, ensures data reliability.

二、核心功能 (Core Functions)

中文

中心视野检查:30°/60° 范围静态阈值 / 超阈值筛查

青光眼诊断:青光眼分期(GSP)、视野缺损分析、进展监测

黄斑评估:10-2 黄斑精细检测

神经眼科:视神经病变、颅高压、偏盲 / 象限盲定位

筛查模式:快速体检、驾照体检、职业病筛查

智能分析:灰度图、3D 视野图、缺损概率图、随访对比

数据管理:存储、打印、导出、多检查对比

English

Central Field: 30°/60° static threshold/suprathreshold screening

Glaucoma: Glaucoma Staging Program (GSP), defect analysis, progression

Macula: 10-2 high-resolution macular test

Neuro-ophthalmology: Optic neuropathy, papilledema, hemianopia localization

Screening: Fast health check, driver’s license, occupational health

Analysis: Gray scale, 3D hill of vision, probability maps, follow-up

Data: Store, print, export, multi-exam comparison

三、产品特点 (Product Features)

中文

便携式:体积小、重量轻、提手设计、可移动出诊

免暗室:封闭遮光设计,普通照明环境即可检查

高速:SPARK 策略约 2–3 分钟 / 眼;快速筛查 < 1 分钟

高精度:135 个测试点、符合 ISO 12866、Goldmann 标准

无运动部件:LED/LCD 固定阵列,稳定耐用、低维护

智能算法:SPARK 基于 9 万 + 病例,稳定抗干扰

多程序:30-2/24-2/10-2、青光眼、黄斑、驾照筛查

易操作:触屏 / 按键、自动对焦、患者引导提示

English

Portable: Compact, lightweight, carry handle, mobile use

No darkroom: Light-shielded, works in normal room light

Fast: SPARK ~2–3 min/eye; screening <1 min

Precise: 135 points, ISO 12866, Goldmann compliant

No moving parts: Fixed LED/LCD array, robust, low maintenance

Smart: SPARK (90k+ cases) stable, artifact-resistant

Multi-program: 30-2/24-2/10-2, glaucoma, macula, driving license

Easy: Touch/buttons, auto-align, patient prompts




四、技术参数 (Technical Specifications)

中文

型号:Easyfield(56920/56930)、Smartfield(便携基础)

检查范围:Easyfield 中心 30°;Smartfield 30°(可扩 60°)

视标:Goldmann III;白光;4–0 dB(10–0.001 asb)

背景亮度:31.5 asb(标准)

测试点:135 个(30-2/24-2/10-2)

策略:Full Threshold、Fast Threshold、SPARK、超阈值

显示:LED 阵列(Easyfield)/ 高亮度 LCD(Smartfield)

电源:100–240 VAC,50/60 Hz;可外接 DC / 车载

尺寸 / 重量:Easyfield 约 35×35×40 cm / 8 kg;Smartfield 更轻

标准:ISO 12866、IEC 60601-1

English

Models: Easyfield (56920/56930), Smartfield (basic portable)

Range: Easyfield central 30°; Smartfield 30° (extend to 60°)

Stimulus: Goldmann III; white; 4–0 dB (10–0.001 asb)

Background: 31.5 asb (standard)

Points: 135 locations (30-2/24-2/10-2)

Strategies: Full Threshold, Fast Threshold, SPARK, Suprathreshold

Display: LED array (Easyfield) / high-luminance LCD (Smartfield)

Power: 100–240 VAC, 50/60 Hz; DC/car adapter

Size/Weight: Easyfield ~35×35×40 cm / 8 kg; Smartfield lighter

Compliance: ISO 12866, IEC 60601-1

五、使用方法 (Operation Method)

中文

准备:开机、校准、患者信息录入

患者:坐姿、下颌 / 额头固定、遮盖单眼、注视中心

设置:选眼、程序(30-2 / 青光眼 / 筛查)、策略

检查:患者见光即按应答器;系统自动测阈值

监控:注视追踪、伪影提示、中途暂停 / 重测

分析:自动生成灰度图、数值、概率图、分期报告

保存 / 打印:存档、打印、导出数据

结束:清洁托架、关机、覆盖防尘

English

Prep: Power on, calibrate, enter patient data

Patient: Sit, chin/forehead rest, patch one eye, fixate center

Setup: Select eye, program (30-2/glaucoma/screen), strategy

Test: Patient presses button on seeing light; auto-threshold

Monitor: Fixation tracking, artifact alert, pause/repeat

Analyze: Auto-generate gray scale, values, probability, staging

Save/Print: Archive, print, export

Finish: Clean rests, power off, dust cover

六、适应症 (Indications)

中文

青光眼:筛查、诊断、分期、病程监测、术后评估

视神经疾病:视神经炎、缺血性病变、视神经萎缩、颅高压

黄斑病变:黄斑裂孔、变性、水肿、前膜的中心视野缺损

视网膜疾病:视网膜色素变性、血管阻塞、脱离的视野缺损

颅脑病变:卒中、肿瘤、外伤所致偏盲、象限盲、暗点

健康体检:常规眼科筛查、职业健康、驾照体检

药物毒性:羟氯喹、乙胺丁醇等毒性视野监测

English

Glaucoma: Screening, diagnosis, staging, progression, post-op

Optic nerve: Neuritis, ischemia, atrophy, papilledema

Macula: Hole, degeneration, edema, epiretinal membrane

Retina: Retinitis pigmentosa, vascular occlusion, detachment

Brain: Stroke, tumor, trauma → hemianopia, quadrantanopia

Screening: General health, occupational, driver’s license

Toxicity: Hydroxychloroquine, ethambutol monitoring

七、禁忌症 (Contraindications)

中文

无法固视≥3 分钟、严重眼球震颤、意识障碍、不配合者

严重屈光不正未矫正、角膜混浊 / 白斑、致密白内障(无法成像)

急性眼表炎症、感染、严重干眼(不耐受检查)

癫痫光敏性、对闪光极度恐惧 / 不耐受

眼压 > 40 mmHg、急性闭角型青光眼发作期

English

Cannot fixate ≥3 min, severe nystagmus, altered consciousness

Uncorrected high refractive error, opacity, dense cataract

Acute infection, inflammation, severe dry eye

Photosensitive epilepsy, extreme photophobia

IOP >40 mmHg, acute angle-closure crisis

八、注意事项 (Precautions)

中文

操作者需专业培训,熟悉程序与质控

检查前清洁下颌托、额托、应答器,防交叉感染

患者摘除软镜≥24h、硬镜≥1 周,稳定屈光状态

确保注视良好,频繁追踪失败需重测

避免强光直射光学口、防震动、防液体渗入

数据为辅助诊断,需结合裂隙灯、OCT、眼压综合判断

儿童、老人需专人协助,保证配合度

English

Operator must be professionally trained

Clean chin/forehead rests, response button to prevent infection

Remove soft lenses ≥24h, rigid ≥1 week before test

Ensure good fixation; repeat if tracking fails often

Avoid strong light, vibration, liquid ingress

Data for reference; combine with slit-lamp, OCT, IOP

Children/elderly need assistance for compliance

九、存储条件 (Storage Conditions)

中文

温度:10°C–35°C

湿度:30%–75%,无冷凝

气压:860–1060 hPa

环境:干燥、清洁、通风、无尘、无腐蚀性气体

避免:阳光直射、高温、潮湿、震动、强磁场、液体接触

长期:防尘罩覆盖、光学部件防潮

English

Temp: 10°C–35°C

Humidity: 30%–75%, non-condensing

Pressure: 860–1060 hPa

Environment: Dry, clean, ventilated, dust-free, no corrosive gas

Avoid: Direct sun, heat, moisture, vibration, strong magnetic fields

Long-term: Dust cover, protect optics from moisture

十、说明书核心信息 (Manual Core Info)

中文

型号:Easyfield®(56920/56930)、Smartfield®

注册:国械注进 20192161661;二类医疗器械

组成:主机、头部托架、应答器、电源、软件、数据线

校准:每日自检;定期用标准模块校准(6–12 个月)

维护:每日清洁;软件定期更新;无易损件

保修:原厂 1–2 年,按厂商条款

安全:IEC 60601-1、EMC 标准;防电击、防辐射

质控:内置固视监控、假阳性 / 假阴性统计、可靠性指数

English

Models: Easyfield® (56920/56930), Smartfield®

Cert: CFDA 20192161661; Class II medical device

Components: Main unit, headrest, response button, power, software, cables

Calibration: Daily self-check; standard module every 6–12 months

Maintenance: Daily cleaning; software updates; no consumables

Warranty: 1–2 years manufacturer

Safety: IEC 60601-1, EMC; electric/shock protection

QC: Fixation monitor, false pos/neg, reliability index

需要我把以上内容整理成可直接复制的 中英文对照说明书精简版(Word 格式) 吗?

双目视力仪59850的产品工作原理中英文,功能中英文,产品特点中英文,技术参数中英文、使用方法中英文、适应症中英文、禁忌症中英文、注意事项中英文,存储条件中英文,说明书中英文核心信息

OCULUS Binoptometer 4P (59850) 双目视力仪 是德国 OCULUS 公司生产的一体化全自动视功能综合检查仪。



一、工作原理 (Working Principle)

中文采用高分辨率 LCD 微显示技术与高速 LCD 快门分光系统。

内置高分辨率彩色 LCD 屏(800×600)投射标准化视标(C 环、字母、数字、儿童符号),色温校准为标准 D65/D55 光源。

通过LCD 电子快门实现双眼分离、交替或同时呈现视标,模拟自然自由空间视觉,无机械部件。

系统按预设程序自动调整视标大小、亮度、对比度与颜色,精确测定双眼视觉功能。

配合自动对焦与距离调节系统(30cm 至无限远),完成远 / 近视力、对比敏感度、立体视等全项检查。

EnglishAdopts high-resolution LCD micro-display and high-speed LCD shutter system.

Internal high-res color LCD (800×600) projects standard optotypes (Landolt C, letters, numbers, symbols), calibrated to D65/D55 standard light.

Electronic LCD shutters separate/alternate/simultaneously present stimuli to both eyes, mimicking natural free-space vision, no moving parts.

System auto-adjusts size, brightness, contrast, color per program for precise binocular function measurement.

Auto-focus & variable distance system (30cm–infinity) enables far/near, contrast, stereo testing.

二、核心功能 (Core Functions)

中文

视力检查:远 / 近视力、裸眼 / 矫正视力、儿童视力(符号 / 图画)

色觉测试:石原氏 / Ishihara、Velhagen 色觉图谱,色盲 / 色弱筛查

双目视功能:水平 / 垂直隐斜、融合功能、立体视、远近眼位评估

对比敏感度:明视觉 / 中间视觉对比敏感度、眩光敏感度测试

调节与聚散:调节幅度、调节反应、正负相对调节、聚散功能

周边视野:7 点位周边视野快速筛查

特殊测试:夜近视评估(-0.5D~-3.5D)、潜伏性远视筛查

数据管理:自定义程序、自动报告、存储 / 打印 / 导出、病例对比

English

Visual Acuity: Far/near, uncorrected/corrected, pediatric (symbols/pictures)

Color Vision: Ishihara, Velhagen plates, color blindness/deficiency screening

Binocular Function: Horizontal/vertical phoria, fusion, stereopsis, near/far fixation

Contrast Sensitivity: Photopic/mesopic CS, glare sensitivity testing

Accommodation/Convergence: Amplitude, response, NRA/PRA, vergence function

Peripheral Field: 7-point rapid peripheral screening

Special Tests: Night myopia (-0.5D~-3.5D), latent hyperopia assessment

Data Management: Custom protocols, auto-reports, save/print/export, comparison

三、产品特点 (Product Features)

中文

一体化全能:单台设备完成视力、色觉、双目视、对比敏感度、调节、视野全功能

自然视觉:自由空间模拟,无仪器性近视 / 近感性集合,数据更真实

LCD 快门技术:无机械运动、静音、高速、稳定耐用、低维护

免暗室:明室环境即可完成全项检查

距离可调:30cm 至无限远连续无级调节,远近测试一键切换

双操控:彩色触屏 + 电脑软件双控制,操作灵活

人体工学:自动升降、可调视角、患者舒适度高

智能便捷:自定义程序、自动分析、一键报告、质控监测

English

All-in-One: Complete vision, color, binocular, CS, accommodation, field in one device

Natural Vision: Free-space simulation, no instrument myopia/proximal convergence

LCD Shutter Tech: No moving parts, silent, fast, stable, low maintenance

No Darkroom: Full testing in ambient light

Variable Distance: 30cm–infinity continuous adjustment, far/near toggle

Dual Control: Color touchscreen + PC software

Ergonomic: Auto-height, adjustable angle, patient comfort

Smart & Fast: Custom protocols, auto-analysis, 1-click reports, QC monitoring

四、技术参数 (Technical Specifications)

中文

型号:Binoptometer 4P(59850)

显示系统:800×600 彩色微 LCD;亮度~300 cd/m²

光源:标准 D65(色觉 D55)

视标:Landolt C 环、字母、数字、儿童符号、E 字(选配)

检查距离:30cm ~ 无限远连续可调

双目分离:高速 LCD 电子快门

尺寸:224×220×(455~560) mm(带升降)

重量:5.6 kg(带升降);4.8 kg(无升降)

电源:100–240 VAC, 50/60 Hz

接口:USB(连接电脑 / 打印机)

标准:DIN EN ISO 8596、DIN 58220、G25/G26/G37/G41

English

Model: Binoptometer 4P (59850)

Display: 800×600 color micro-LCD; ~300 cd/m² luminance

Light Source: Standard D65 (D55 for color)

Optotypes: Landolt C, letters, numbers, pediatric symbols, E (optional)

Test Distance: 30cm – infinity continuously variable

Binocular Separation: High-speed LCD electronic shutters

Dimensions: 224×220×(455–560) mm (with height adj.)

Weight: 5.6 kg (with adj.); 4.8 kg (w/o adj.)

Power: 100–240 VAC, 50/60 Hz

Interface: USB (PC/printer)

Compliance: DIN EN ISO 8596, DIN 58220, G25/G26/G37/G41

五、使用方法 (Operation Method)

中文

准备:开机自检,校准光源;录入患者信息

患者就位:坐姿端正,下颌 / 额头靠紧托架,双眼平视中心

参数设置:选择测试眼(单眼 / 双眼)、程序、距离、视标类型

检查:患者按指导注视 / 应答;系统自动投射、测量、记录

监控:实时监测固视、伪迹;异常自动提示 / 重测

分析报告:自动生成数据、图表、结论、诊断建议

保存输出:存储、打印、导出报告;完成后清洁关机

English

Prep: Power on self-test, calibrate light; enter patient data

Patient Positioning: Sit upright, chin/forehead rest, eyes forward

Setup: Select eye (mono/binocular), protocol, distance, optotype

Examination: Patient responds per instruction; system auto-measures

Monitor: Real-time fixation/artifact check; alert/repeat if abnormal

Analyze & Report: Auto-generate data, charts, conclusion, diagnosis

Save & Finish: Store, print, export; clean & power off

六、适应症 (Indications)

中文

屈光检查:近视、远视、散光、屈光参差的矫正视力评估

视光门诊:双眼视功能异常、隐斜、斜视、融合障碍诊断

儿童眼科:弱视筛查、立体视发育、色觉评估

白内障术前:视功能、对比敏感度、眩光评估

屈光手术:术前筛查、术后视觉质量评估

青光眼 / 神经眼科:中心 / 周边视野、对比敏感度缺损筛查

职业体检:驾照、飞行员、特殊职业视力 / 色觉 / 立体视认证

视疲劳诊疗:调节 / 聚散功能异常、眼肌疲劳病因分析

English

Refraction: Myopia, hyperopia, astigmatism, anisometropia correction

Optometry: Binocular dysfunction, phoria, strabismus, fusion disorders

Pediatric: Amblyopia, stereopsis development, color vision

Cataract Pre-op: Visual function, CS, glare assessment

Refractive Surgery: Pre-op screening, post-op quality evaluation

Glaucoma/Neuro: Central/peripheral field, CS defect screening

Occupational: Driver, pilot, professional vision/color/stereo certification

Asthenopia: Accommodative/vergence dysfunction, eye strain analysis

七、禁忌症 (Contraindications)

中文

无法配合固视、严重眼球震颤、意识障碍者

急性眼表感染、炎症、严重干眼、角膜损伤期

严重屈光介质混浊(白内障、角膜白斑)无法识别视标

癫痫光敏性、对强光 / 闪烁极度不耐受者

无法保持坐姿、头部剧烈震颤者

English

Unable to fixate, severe nystagmus, altered consciousness

Acute ocular infection, inflammation, severe dry eye, corneal injury

Severe media opacity (cataract, leukoma) preventing stimulus recognition

Photosensitive epilepsy, extreme photophobia

Unable to sit still, severe head tremor

八、注意事项 (Precautions)

中文

操作者需专业培训,熟悉操作与质控流程

检查前清洁消毒下颌托、额托,预防交叉感染

患者摘除隐形眼镜(软镜≥24h,硬镜≥1 周)后检查

确保环境光线稳定,避免强光直射设备屏幕

儿童、老年人需专人辅助,确保配合与安全

数据为辅助诊断,需结合裂隙灯、验光、眼压等综合判断

定期校准光源与显示系统(建议每 6 个月)

English

Operator must be professionally trained

Clean/disinfect chin/forehead rests to prevent infection

Remove contacts: soft ≥24h, rigid ≥1 week before test

Maintain stable ambient light; avoid direct screen glare

Assist children/elderly for cooperation & safety

Data for reference; correlate with slit-lamp, refraction, IOP

Calibrate light/display regularly (every 6 months)

九、存储条件 (Storage Conditions)

中文

温度:10°C ~ 35°C

湿度:30% ~ 75%,无冷凝

气压:860 ~ 1060 hPa

环境:干燥、清洁、通风、无尘、无腐蚀性气体

避免:阳光直射、高温、潮湿、震动、强磁场、液体溅入

长期存放:防尘罩覆盖,光学部件防潮保护

English

Temperature: 10°C ~ 35°C

Humidity: 30% ~ 75%, non-condensing

Pressure: 860 ~ 1060 hPa

Environment: Dry, clean, ventilated, dust-free, no corrosive gas

Avoid: Direct sun, heat, moisture, vibration, strong magnetic fields

Long-term: Dust cover, protect optics from moisture

十、说明书核心信息 (Manual Core Info)

中文

型号:Binoptometer 4P(59850)


组成:主机、升降支架、控制器、电源、软件、数据线

校准:每日自检;每 6 个月专业校准

维护:每日清洁外壳 / 托架;定期软件更新

保修:原厂 1~2 年,按厂商条款

安全:符合 IEC 60601-1、EMC 标准

有效期:主机 5~8 年(按厂商规范)

English

Model: Binoptometer 4P (59850)

Certification: CFDA 20162160026; Class II medical device

Components: Main unit, height stand, controller, power, software, cables

Calibration: Daily self-test; professional calibration every 6 months

Maintenance: Daily cleaning; regular software updates

Warranty: 1–2 years manufacturer warranty

Safety: IEC 60601-1, EMC compliant

Lifespan: 5–8 years (per manufacturer specs)


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.


热门标签:厂家供应欧科路双目视力仪4P59850,欧科路双目视力仪4P,欧科路双目视力仪

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