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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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厂商直销国际听力前庭功能检查系统EyeSeeCam

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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20152071274更新时间:2026/10/19 9:40:51

产品摘要:厂商直销国际听力前庭功能检查系统EyeSeeCam

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厂商直销国际听力前庭功能检查系统EyeSeeCam
桂经理19117326863微xin同号

管理类别

第二类

型号规格

EyeSeeCam

结构及组成/主要组成成分

EyeSeeCam是由护目镜,摄像机,激光校准器,卷尺,USB线,EyeSeeCam软件安装光盘(版本1),OtoAccess数据库软件安装光盘组成。

适用范围/预期用途

EyeSeeCam通过对头部和眼部运动速度的客观测量,同时显示出头部旋转平面上的前庭眼动神经反射(VOR)增益,从而提供人体平衡系统性能诊断的信息。

一、工作原理(Working Principle)

中文基于视频头脉冲试验(vHIT)与3D 眼动追踪:

  1. 红外单眼 / 双眼高速摄像(220Hz)实时捕捉瞳孔运动,红外照明确保暗环境测试。

  2. 眼罩内置惯性测量单元(IMU)同步采集头部角速度、加速度,3D 建模匹配头动 / 眼动。

  3. 前庭眼反射(VOR)分析:健康者头动时眼球反向稳定固视;前庭损伤者眼随头动,出现显性 / 隐性纠正性扫视。

  4. 量化 VOR 增益(眼速 / 头速)、相位、潜伏期,自动识别 6 半规管(水平、前、后半规管)功能缺损。

EnglishBased onVideo Head Impulse Test (vHIT)and3D eye movement tracking:

  1. High-speed infrared monocular/binocular camera(220Hz) captures pupil movement in real time; IR illumination enables dark-room testing.

  2. Goggle-integrated IMUsynchronously collects head angular velocity/acceleration, with 3D modeling for precise head-eye matching.

  3. Vestibulo-Ocular Reflex (VOR) analysis: Healthy subjects stabilize gaze during head movement; vestibular loss causes eyes to follow head, generatingovert/covert corrective saccades.

  4. Quantifies VOR gain(eye velocity/head velocity), phase, latency; auto-detects 6 semicircular canal (horizontal, anterior, posterior) deficits.


二、产品功能(Product Functions)

中文

  1. 6 半规管 vHIT 测试:水平、右前左后(RALP)、左前右后(LARP)全平面高频 VOR 评估。

  2. 眼动参数测量:VOR 增益、相位差、潜伏期、显性 / 隐性扫视、不对称率。

  3. 自发 / 凝视眼震:记录基线眼震,排除中枢 / 前庭静息损伤。

  4. 实时分析与回放:同步头眼曲线、3D 轨迹、视频录制、逐帧 / 慢放。

  5. 报告与数据:自动生成 PDF 报告、OtoAccess 数据库、多格式导出。

  6. 校准与质控:激光校准、一键定位、质量评分、伪迹识别。

English

  1. 6-canal vHIT testing: High-frequency VOR assessment for horizontal, RALP, LARP planes.

  2. Ocular parameter measurement: VOR gain, phase, latency, overt/covert saccades, asymmetry ratio.

  3. Spontaneous/gaze nystagmus: Records baseline nystagmus to rule out central/resting vestibular lesions.

  4. Real-time analysis & playback: Synchronized head-eye curves, 3D tracing, video recording, fffffframe-by-fffffframe/slow-motion.

  5. Reporting & data: Auto PDF reports, OtoAccess database, multi-format export.

  6. Calibration & QC: Laser calibration, one-click positioning, quality scoring, artifact detection.




三、产品特点(Product Features)

中文

  • 超轻防滑眼罩:≤250g,人体工学,防滑动,长时间舒适。

  • 220Hz 高速追踪:毫秒级捕捉隐性扫视,避免假阴性。

  • 单 / 双眼切换:球窝式相机,左右眼快速互换。

  • 3D IMU 同步:头眼运动毫秒级对齐,精度 ±0.1°。

  • 智能算法:自动增益计算、扫视识别、伪迹过滤、质量评分。

  • 便携易用:USB 直连 PC、无线脚踏、触屏操作、快速校准。

  • 临床高效:5–10 分钟 / 例,即时结果,适合急诊 / 门诊。

English

  • Ultra-light non-slip goggle: ≤250g, ergonomic, slip-resistant, long-lasting comfort.

  • 220Hz high-speed tracking: Captures covert saccades in milliseconds, eliminates false negatives.

  • Monocular/binocular switch: Ball-and-socket camera, quick left/right eye swap.

  • 3D IMU synchronization: Millisecond head-eye alignment, accuracy ±0.1°.

  • Smart algorithms: Auto gain calculation, saccade identification, artifact filtering, quality scoring.

  • Portable & user-friendly: USB direct PC connection, wireless footswitch, touchscreen, fast calibration.

  • Clinically efficient: 5–10 mins/patient, instant results, ideal for ER/clinic.


四、技术参数(Technical Specifications)

中文

  • 相机:红外 USB 单眼(可选双眼),220 帧 / 秒,分辨率 640×480。

  • 追踪范围:水平 ±30°,垂直 ±25°,精度 **±0.1°**。

  • IMU:3 轴陀螺仪 + 3 轴加速度计,采样率 1kHz,延迟 < 1ms。

  • 眼罩:重量 **≤250g**,可调节,红外照明,防眩光。

  • 校准:激光自动校准,5 点固视,10 秒完成。

  • 软件:Windows 兼容,OtoAccess 数据库,实时 3D 可视化。

  • 接口:USB 2.0/3.0,支持脚踏、无线遥控。

  • 电源:USB 总线供电(5V/500mA),无外接电源。

  • 尺寸:眼罩 280×200×110mm,便携箱 450×350×150mm。

English

  • Camera: Infrared USB monocular (binocular optional),220 fps, resolution 640×480.

  • Tracking range: Horizontal ±30°, vertical ±25°, accuracy±0.1°.

  • IMU: 3-axis gyro + 3-axis accelerometer, 1kHz sampling, latency <1ms.

  • Goggle: Weight≤250g, adjustable, IR illumination, anti-glare.

  • Calibration: Laser auto-calibration, 5-point fixation, 10-second completion.

  • Software: Windows compatible, OtoAccess database, real-time 3D visualization.

  • Interfaces: USB 2.0/3.0, supports footswitch, wireless remote.

  • Power: USB bus-powered (5V/500mA), no external adapter.

  • Dimensions: Goggle 280×200×110mm, case 450×350×150mm.


五、使用方法(Usage Method)

中文

  1. 准备

    • 设备:USB 连接 PC,启动软件,自检校准。

    • 患者:摘除眼镜 / 隐形 / 眼妆,取坐位,头固定,注视靶点。

    • 眼罩:佩戴舒适,相机对准瞳孔,激光校准。

  2. 测试流程

    • 基线:自发眼震→凝视眼震(正中 / 左 / 右 / 上 / 下)。

    • vHIT:水平→前→后半规管;每方向 10–15 次快速小幅度被动头动(15–20°,150–250°/s)。

    • 分析:软件自动计算增益、不对称、扫视;质控评分。

  3. 结束

    • 保存数据→生成报告→清洁眼罩→关机。

English

  1. Preparation

    • Equipment: USB-connect to PC, launch software, self-test & calibrate.

    • Patient: Remove glasses/contacts/makeup, seated, head stabilized, fixate target.

    • Goggle: Fit comfortably, camera aligned to pupil, laser calibration.

  2. Test Procedure

    • Baseline: Spontaneous nystagmus → gaze nystagmus (center/left/right/up/down).

    • vHIT: Horizontal → anterior → posterior canals; 10–15rapid small-amplitude passive head turns(15–20°, 150–250°/s) per direction.

    • Analysis: Auto gain/asymmetry/saccade calculation; quality scoring.

  3. Completion

    • Save data → generate report → clean goggle → power down.


六、适应症(Indications)

中文

  • 急性 / 慢性眩晕、头晕、平衡障碍。

  • 前庭神经炎、梅尼埃病、突聋伴眩晕。

  • BPPV(半规管类型鉴别)。

  • 耳毒性药物(氨基糖苷类)前庭损伤监测。

  • 颅脑外伤(TBI)、脑卒中、多发性硬化前庭评估。

  • 听神经瘤、小脑桥脑角病变术前 / 术后。

  • 前庭康复训练疗效随访。

  • 飞行员 / 驾驶员前庭功能体检。

English

  • Acute/chronic vertigo, dizziness, balance disorders.

  • Vestibular neuritis, Meniere’s disease, sudden deafness with vertigo.

  • BPPV(canal subtype differentiation).

  • Monitoring ototoxic drug (aminoglycoside) vestibular injury.

  • Traumatic brain injury (TBI), stroke, multiple sclerosis vestibular assessment.

  • Pre/post-op for acoustic neuroma, CPA lesions.

  • Vestibular rehabilitation follow-up.

  • Pilot/driver vestibular medical exam.


七、禁忌症(Contraindications)

中文

  • 绝对禁忌

    • 失明、严重眼球震颤、固定性斜视无法固视。

    • 急性眼部损伤 / 手术(4 周内)、角膜溃疡。

    • 颈椎骨折 / 脱位、严重颈椎病(禁头动)。

    • 癫痫发作期、严重精神障碍无法配合。

  • 相对禁忌

    • 严重心脑血管疾病(心梗、脑梗急性期)。

    • 高度近视(>800°)、视网膜脱离史。

    • 面部畸形无法佩戴眼罩。

English

  • Absolute Contraindications

    • Blindness, severe nystagmus, fixed strabismus (no fixation).

    • Acute eye injury/surgery (within 4 weeks), corneal ulcer.

    • Cervical fracture/dislocation, severe cervical spondylosis (no head movement).

    • Active epilepsy, severe mental disorder (uncooperative).

  • Relative Contraindications

    • Severe cardio-cerebrovascular disease (acute MI/stroke).

    • High myopia (>800°), history of retinal detachment.

    • Facial deformity (cannot wear goggle).


八、注意事项(Precautions)

中文

  • 患者:检查前 48h 禁酒、镇静剂、抗眩晕药;避免空腹 / 过饱。

  • 操作:培训后上岗;头动快速、被动、小幅度、不可预测。

  • 质控:校准到位;排除眼罩滑动、眨眼、固视丢失伪迹。

  • 安全:测试中观察眩晕、恶心,不适即停;儿童 / 老人需陪同。

  • 清洁:75% 酒精擦拭眼罩,禁液体渗入相机。

  • 解读:结合临床、VNG、VEMP,避免单一 vHIT 诊断。

English

  • Patient: No alcohol/sedatives/anti-vertigo meds 48h prior; avoid fasting/overfull.

  • Operation: Trained operators only; head turnsrapid, passive, small, unpredictable.

  • QC: Proper calibration; exclude goggle slip, blink, fixation loss artifacts.

  • Safety: Monitor vertigo/nausea; stop if distressed; pediatric/geriatric with escort.

  • Cleaning: 75% alcohol wipe goggle; no liquid into camera.

  • Interpretation: Correlate with clinical, VNG, VEMP; avoid sole vHIT diagnosis.


九、存储条件(Storage Conditions)

中文

  • 温度:工作 10–35℃;存储 - 20–+60℃。

  • 湿度:30%–75%(无冷凝)。

  • 气压:86–106kPa。

  • 环境:干燥、通风、无尘;远离热源、腐蚀、强电磁干扰。

  • 设备:眼罩入专用箱;镜头盖保护;线缆整理;定期数据备份。

English

  • Temperature: Operating 10–35℃; Storage -20–+60℃.

  • Humidity: 30%–75% (non-condensing).

  • Pressure: 86–106kPa.

  • Environment: Dry, ventilated, dust-free; away from heat, corrosion, strong EMI.

  • Equipment: Goggle in case; lens cap on; cables organized; regular data backup.


十、说明书核心信息(Manual Core)

中文

  • 制造商:Interacoustics A/S(丹麦),CE 0123,IEC 60601-1。

  • 软件版本:vHIT 4.0+,兼容 OtoAccess 8.0+。

  • 维护:每月校准;每季度清洁传感器;年度专业维护。

  • 故障:追踪异常→重校准;连接→查 USB / 驱动;软件→重启 / 更新。

  • 保修:整机 2 年,相机 1 年;人为损坏 / 非授权维修除外。

  • 合规:医用 BF 类设备;禁易燃环境;医疗专业人员。

English

  • Manufacturer: Interacoustics A/S (Denmark), CE 0123, IEC 60601-1.

  • Software: vHIT 4.0+, OtoAccess 8.0+ compatible.

  • Maintenance: Monthly calibration; quarterly sensor cleaning; annual professional service.

  • Troubleshooting: Tracking error → recalibrate; connection → check USB/driver; software → restart/update.

  • Warranty: 2-year system, 1-year camera; excludes damage/unauthorized repair.

  • Compliance: Medical Type BF; no flammable environments; for medical professionals only.

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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