厂家供应尔听美眼震视图仪Type 1091
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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20252070567更新时间：2026/10/16 11:11:02
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厂家供应尔听美眼震视图仪Type 1091
桂经理19117326863微xin同号
管理类别
第二类
型号规格
Type 1091
结构及组成/主要组成成分
本产品由双眼视频眼镜、耳遂听（OTOsuite）前庭软件(发布版本：4)、视觉屏蔽面板、LCD面板（可选配件）、面垫(047451, 045656, 045657, 045641)组成。
适用范围/预期用途
本产品通过测量、记录、显示和计算眼球和头部运动来辅助医生评估前庭眼反射和眼震。
产品储存条件及有效期
一、工作原理 (Working Principle)
中文通过红外高清视频采集技术，由眼罩式双红外摄像头实时捕捉眼球运动影像（黑暗环境下亦可清晰成像）。影像信号经高速数字化处理，追踪瞳孔中心位置与眼球旋转角度，同步记录水平、垂直、旋转（ torsional）三维眼震参数。结合头部运动传感器（9 轴）数据，系统分析前庭 - 眼反射（VOR） 功能，自动计算眼震慢相速度（SPV）、频率、幅度等核心指标。通过视动刺激、位置变换、冷热空气 / 水刺激等诱发试验，客观评估外周与中枢前庭系统功能状态。
EnglishUtilizes infrared high-definition video technology with binocular infrared cameras in goggles to capture real-time eye movements (clearly visible even in darkness). The video signal is digitized at high speed to precisely track pupil center and eye torsion, recording 3D nystagmus parameters (horizontal, vertical, torsional). Integrated with 9-axis head motion sensors, the system analyzes vestibulo-ocular reflex (VOR) function, automatically calculating slow phase velocity (SPV), frequency, and amplitude. Evoked tests (optokinetic, positional, caloric air/water) ｏbjectively evaluate peripheral and central vestibular function.
二、功能 (Functions)
中文
眼动基本测试：自发性眼震、凝视试验、扫视试验、平稳跟踪、视动性眼震
位置与变位测试：Dix-Hallpike、滚转试验（Roll Test）、静态位置试验，诊断 BPPV
前庭诱发测试：双温试验（空气 / 水刺激）、固视抑制试验，评估半规管功能
三维眼震分析：水平 / 垂直 / 旋转眼震全参数测量、SPV 自动计算、波形回放
数据管理：自动报告、参数统计、PACS 对接、历史数据对比、远程传输
头动同步：9 轴传感器实时监测头位，排除头动干扰，提升结果准确性
English
Basic Oculomotor Tests: Spontaneous nystagmus, gaze, saccade, smooth pursuit, optokinetic nystagmus
Positional Tests: Dix-Hallpike, Roll Test, static positioning for BPPV diagnosis
Vestibular Evocation: Bithermal caloric (air/water), fixation suppression, semicircular canal assessment
3D Nystagmus Analysis: Full horizontal/vertical/torsional measurement, auto SPV, waveｆorm review
Data Management: Auto-reporting, statistics, PACS integration, comparison, remote transfer
Head Motion Sync: 9-axis sensors eliminate head-movement artifacts, ensuring accuracy
三、产品特点 (Product Features)
中文
红外双目成像：638×478 高分辨率，250Hz 采样率，捕捉微弱 / 旋转眼震
三维追踪：旋转眼震识别误差≤±1.2°，头动速度误差≤±3°/s
空气冷热刺激（选配 ICS Aircal）：温度 21–30°C（冷）/40–49°C（热），精度 ±0.5°C，舒适
一体化眼罩：固视抑制灯、激光校准、防眩光，适配不同脸型
智能软件：3 种分析预案（A/B/C），自动识别伪差，支持手动编辑
安全隔离：BF 型应用部分，电磁兼容强，适配手术室 / 门诊环境
便携集成：体积紧凑、即插即用，兼容尔听美全系列前庭设备
English
Infrared Binocular Imaging: 638×478 resolution, 250Hz sampling, detects weak/torsional nystagmus
3D Precision: Torsion error ≤±1.2°, head velocity error ≤±3°/s
Air Caloric (ICS Aircal): 21–30°C (cool)/40–49°C (warm), ±0.5°C accuracy, non-invasive
Integrated Goggles: Fixation light, laser calibration, anti-glare, ergonomic fit
Smart Software: 3 analysis profiles (A/B/C), auto-artifact rejection, manual editing
Safety Isolation: Type BF, high EMI immunity, OR/clinic compatible
Compact Integration: Portable, plug-and-play, full Otometrics compatibility
四、技术参数 (Technical Specifications)
中文
摄像头：双目红外 CMOS，分辨率 638×478，采样率 250Hz
眼动测量：水平 ±30°、垂直 ±25°、旋转 ±20°；SPV 0.5–100°/s
头动传感器：9 轴（加速度 / 陀螺 / 地磁），采样率 250Hz
刺激器（选配）：空气刺激，温度 21–49°C 可调，精度 ±0.5°C
软件系统：Windows 平台，支持 VNG 全测试，报告自动生成
接口：USB 3.0、以太网、脚踏开关、刺激器控制口
电源：AC 100–240V，50/60Hz，DC 19V 适配器
尺寸 / 重量：眼罩 280×180×80mm / 0.35kg；主机 420×360×150mm / 6.8kg
安全：BF 型，IPX0，符合 IEC 60601-1
English
Cameras: Binocular infrared CMOS, 638×478, 250Hz sampling
Eye Measurement: Horizontal ±30°, vertical ±25°, torsion ±20°; SPV 0.5–100°/s
Head Sensors: 9-axis (accel/gyro/mag), 250Hz
Stimulator (Opt): Air caloric, 21–49°C adjustable, ±0.5°C accuracy
Software: Windows-based, full VNG battery, auto-reporting
Interfaces: USB 3.0, Ethernet, footswitch, stimulator control
Power: AC 100–240V, 50/60Hz, 19V DC adapter
Dimensions/Weight: Goggles 280×180×80mm / 0.35kg; Main unit 420×360×150mm / 6.8kg
Safety: Type BF, IPX0, IEC 60601-1 compliant
五、使用方法 (Usage)
中文
准备：开机自检；患者禁药 24 小时（镇静 / 前庭抑制剂）、禁酒、空腹 2 小时；清洁耳道
校准：佩戴眼罩；激光校准瞳孔；头位归零；系统自动校准眼动 - 角度关系
基础测试：自发眼震→凝视→扫视→平稳跟踪→视动（闭眼 / 睁眼）
位置测试：坐位→仰卧→左右侧卧→Dix-Hallpike→Roll Test，记录眼震
冷热试验（选配）：外耳道注入冷热空气；每侧 60 秒；记录 SPV 并计算单侧减弱（UW）
分析报告：自动计算参数；编辑伪差；生成 PDF 报告；存储 / 打印 / 传输
收尾：取下眼罩；清洁消毒；关机；整理设备
English
Preparation: Self-test; patient NPO 2hrs, no meds/alcohol 24hrs; clear ear canals
Calibration: Fit goggles; laser pupil calibration; head zero; auto eye-angle calibration
Basic Tests: Spontaneous → gaze → saccade → pursuit → optokinetic (eyes open/closed)
Positional Tests: Sitting → supine → lateral → Dix-Hallpike → Roll; record nystagmus
Caloric (Opt): Air irrigation; 60s/side; record SPV, calculate unilateral weakness (UW)
Analysis: Auto-calculate; edit artifacts; PDF report; store/print/transfer
Completion: Remove goggles; disinfect; power down; restock
六、适应症 (Indications)
中文
眩晕 / 头晕病因诊断（耳石症、梅尼埃病、前庭神经炎、前庭性偏头痛）
平衡障碍、共济失调、空间定向障碍
眼动异常、复视、可疑中枢 / 外周前庭病变
脑外伤、脑卒中、小脑病变、椎 - 基底动脉供血不足
耳科术前 / 术后前庭功能评估、康复训练疗效监测
飞行 / 航海人员前庭功能筛查、运动病评估
English
Vertigo/dizziness diagnosis (BPPV, Meniere’s, vestibular neuritis, migraine)
Balance disorders, ataxia, spatial disorientation
Ocular motor abnormalities, diplopia, central/peripheral vestibular lesions
TBI, stroke, cerebellar disease, vertebrobasilar insufficiency
Pre/post-op vestibular assessment, rehabilitation monitoring
Aviation/marine screening, motion sickness evaluation
七、禁忌症 (Contraindications)
中文
绝对禁忌：癫痫发作期、颅内压增高、急性外耳道炎 / 中耳炎、鼓膜穿孔（水冷）
相对禁忌：眩晕急性发作期、脑血管意外急性期、严重心肺衰竭、卧床不起
服用中枢兴奋 / 抑制药、精神疾病无法配合、颈部活动严重受限
眼部严重感染、角膜损伤、固视不能（影响测试结果）
English
Absolute: Active epilepsy, increased ICP, acute otitis externa/media, perforated eardrum (water caloric)
Relative: Acute vertigo, acute stroke, severe cardiopulmonary failure, bedridden
CNS stimulants/depressants, psychosis, severe neck mobility restriction
Severe eye infection, corneal injury, inability to fixate
八、注意事项 (Precautions)
中文
患者准备：检查前 24 小时禁用药 / 酒；清洁耳道；去除眼部化妆 / 假睫毛
安全：全程监护生命体征；眩晕剧烈时暂停；备止晕 / 急救药
操作：眼罩贴合无漏光；头位固定；刺激温度；避免头动干扰
感染控制：眼罩 / 耳塞一人一消毒；耦合剂无菌；防止交叉污染
设备：定期校准摄像头 / 传感器；防潮防尘；远离强电磁（电刀 / MRI）
结果：结合病史、听力、影像学；排除伪差；必要时复查
English
Patient Prep: No meds/alcohol 24hrs; clear ears; remove eye makeup/lashes
Safety: Monitor vitals; pause if severe vertigo; have anti-vertigo/emergency meds
Operation: Light-tight goggles; stable head; precise temp; avoid head motion
Infection Control: Disinfect goggles/ear tips; sterile gel; prevent cross-contamination
Equipment: Regular calibration; moisture/dust protection; isolate from EMI (ESU/MRI)
Results: Correlate with history, audiology, imaging; review artifacts; repeat if needed
九、存储条件 (Storage Conditions)
中文
环境：温度 10–30℃；湿度 30%–70%；无腐蚀、无尘、通风良好
防尘防潮：眼罩放入干燥盒；镜头盖保护；电缆盘绕松弛；设备罩防尘
长期存储：每 3 个月通电自检；校准传感器；电池（如有）定期充电
运输：防震箱包装；温度 0–40℃；避免剧烈震动 / 摔落
English
Environment: 10–30°C, 30–70%RH, non-corrosive, dust-free, ventilated
Protection: Goggles in dry case; lens caps; loose cables; equipment cover
Long-Term: Power on every 3 months; calibrate sensors; battery maintenance
Transport: Shock-proof case; 0–40°C; avoid vibration/drops
十、说明书核心信息 (Manual Core Inｆormation)
中文
注
系统组成：主机、红外眼罩、9 轴头动传感器、冷热刺激器（选配）、软件、脚踏开关
维护：每日清洁消毒；每周校准；年度预防性维护；软件更新
故障处理：
无图像→查摄像头 / USB / 电源
眼震捕捉差→清洁镜头 / 重新校准
刺激异常→查温度 / 气流 / 连接
保修：整机 1 年；传感器 / 摄像头 2 年；耗材（耳塞 / 罩）3 个月
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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