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厂商直供诺诚平衡检测仪Balance-A,Balance-B
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厂商直供诺诚平衡检测仪Balance-A,Balance-B
桂经理19117326863微xin同号
桂经理19117326863微xin同号
管理类别
第二类
型号规格
Balance-A,Balance-B
结构及组成/主要组成成分
Balance-A：由平衡架、直立式检查装置、直坐式检查装置、电源适配器MPU63-107、USB延长数据线、平衡检测与训练软件（型号为Balance-A/B，发布版本号：V2）组成。Balance-A/B：由平衡架、直立式检查装置、电源适配器MPU63-107、USB延长数据线、平衡检测与训练软件（型号为Balance-B，发布版本号：V2）组成。
适用范围/预期用途
产品适用于人体静态平衡参数的采集，供临床参考和辅助人体平衡功能的训练。
1、工作原理 Working Principle
中文： 设备基于压力传感器阵列采集人体站立 / 坐姿状态下足底、臀部压力分布，实时计算压力中心 COP（重心）轨迹、摆动范围、摆动速度、摆动椭圆面积等生物力学指标；结合视觉生物反馈技术，受试者可视重心偏移，完成平衡评估与互动式康复训练；系统软件完成数据运算、指标输出与报告生成，用于人体静态平衡参数采集，供临床参考与辅助平衡功能训练。
English： This device adopts pressure‑sensor array to acquire plantar and hip pressure distribution under standing or sitting posture. It calculates real‑time COP (Center‑of‑Pressure) trajectory, sway range, sway velocity, sway ellipse area and other biomechanical parameters. Supported by visual biofeedback, subjects observe center‑of‑gravity offset for balance assessment and interactive rehabilitation training. Software perｆorms data computation, index output and report generation. It collects human static balance parameters for clinical reference and auxiliary balance function training。
2、产品功能 Product Functions
中文
平衡评估：静态站立平衡测试；Balance‑A 额外支持坐姿平衡、坐‑站转换过程平衡检测；采集重心摆动全套指标，量化平衡障碍程度，辅助跌倒风险评估，输出测评报告。
生物反馈训练：多媒体视觉互动训练模式，重心转移针对性训练，分级难度，改善姿势控制、本体感觉、平衡稳定性。
数据管理：患者档案存储、历史对比、报告打印导出。
English
Balance Assessment: static standing balance test. Balance‑A additionally supports sitting‑balance and sit‑to‑stand transition balance test. Collect full set of center‑of‑gravity sway indexes to quantify balance impairment, assist fall‑risk evaluation and generate test reports。
Biofeedback Training: multimedia visual interactive training mode, targeted weight‑shift training with graded difficulty, to improve postural control, proprioception and balance stability。
Data Management: patient file storage, historical data comparison, report print‑out and export.
3、产品特点 Product Features
中文
高精度传感：站立脚垫 8 路压力传感器；Balance‑A 坐垫配置 4 路传感器，采集坐姿压力数据。
Balance‑A 支持站姿、坐姿、坐站转换多姿态检测；Balance‑B 仅站立姿态检测。
视觉生物反馈互动训练，游戏化训练模式提升受试者依从性。
坐垫高度可调（Balance‑A），适配不同身高受试者。
软件自动计算平衡量化指标，可生成标准化临床报告。
整机模块化，USB 数据传输，搭配外置电脑运行软件。
English
High‑precision sensing: 8‑channel pressure sensors for standing platｆorm; Balance‑A cushion equipped with 4‑channel sensors for sitting pressure acquisition。
Balance‑A supports multi‑posture test: standing, sitting and sit‑to‑stand transition; Balance‑B for standing test only.
Visual biofeedback interactive training; gamified training mode improves subject compliance.
Height‑adjustable cushion (Balance‑A only), adaptable for subjects of different heights.
Software automatically calculates quantitative balance indexes and generates standardized clinical reports.
Modular hardware, USB data transmission; operated with external PC.
4、技术参数 Technical Specifications
中文
表格
| 项目 | 参数 |
|---|---|
| 型号 | Balance‑A（站姿 + 坐姿模块）；Balance‑B（仅站姿模块） |
| 站立平台传感器数量 | 8 个压力传感器 |
| 坐姿坐垫传感器（仅 Balance‑A） | 4 个压力传感器 |
| 软件版本 | Balance‑A/B V2.0 |
| 数据接口 | USB |
| 电源适配器 | MPU63‑107，输入 AC100‑240V，输出 DC |
| 被测者最大承重 | 150kg |
| 输出指标 | COP 轨迹、摆动速度、摆动椭圆面积、X/Y 轴偏移、重心位移长度等 |
| 运行软件环境 | Windows 操作系统（外置电脑，设备不含电脑） |
| 整机组成 | 平衡架、直立式检查装置、【Balance‑A 含直坐式检查装置】、电源适配器、USB 数据线、软件 U 盘 |
English
表格
| Item | Specifications |
|---|---|
| Model | Balance‑A (standing+sitting module); Balance‑B (standing‑only module) |
| Standing‑platｆorm sensors | 8 pressure sensors |
| Sitting‑cushion sensors (Balance‑A only) | 4 pressure sensors |
| Software Version | Balance‑A/B V2.0 |
| Data Interface | USB |
| Power Adapter | MPU63‑107, Input AC100‑240V, DC output |
| Max Subject Weight | 150 kg |
| Output Parameters | COP trajectory, sway velocity, sway ellipse area, X/Y offset, COP path length etc. |
| Software Environment | Windows OS (external PC not included with device) |
| System Composition | balance ｆframe, upright testing unit,【sitting‑posture unit for Balance‑A only】, power adapter, USB cable, software USB‑disk |
5、使用方法 Operating Method
中文
设备安装：将平衡检测仪硬件通过 USB 连接至预装软件的电脑，接通电源，启动软件。Balance‑A 按需装配坐姿坐垫组件，调节坐垫高度。
受试者录入：新建 / 调取患者信息，选择测试项目（站立静态平衡 / 坐姿平衡 / 坐‑站转换 / 训练模式）。
测试准备：受试者脱去厚鞋，赤脚 / 薄袜站于站立垫（Balance‑A 坐姿测试坐于坐垫），手扶安全扶手，保持稳定。
执行测试：按软件提示完成睁眼 / 闭眼等条件测试；训练模式跟随屏幕视觉提示完成重心控制训练。
结束采集：测试完成，软件生成平衡评估报告，查看、保存、打印报告。
测试完毕关闭软件，切断设备电源。
English
Installation: Connect hardware to PC with pre‑installed software via USB cable, power‑on and launch software. Assemble sitting‑cushion module for Balance‑A and adjust cushion height as needed.
Subject entry: create or retrieve patient profile; select test item: static standing balance / sitting balance / sit‑to‑stand transition / training mode.
Pre‑test preparation: subject removes thick footwear, stands bare‑foot or with thin socks on standing platｆorm (sit on cushion for Balance‑A sitting test). Hold safety handrails and keep stable posture.
Run test: perｆorm open‑eye / closed‑eye test following software prompts. For training mode, subject perｆorms center‑of‑gravity control following on‑screen visual guidance.
Post‑test: software generates balance assessment report; view, save or print report.
Shut‑down: close software and power off device.
6、适应症 / 适用范围 Indications / Intended Use
中文：适用于人体静态平衡参数的采集，供临床参考和辅助人体平衡功能的训练。临床用于脑卒中、脑外伤、帕金森、前庭功能障碍、老年跌倒风险筛查、骨科术后平衡康复等人群的平衡评估与辅助康复训练。
注意：本设备仅做参数采集、辅助训练，不能作为单一诊断依据。
English: For acquisition of human static‑balance parameters for clinical reference and auxiliary human balance‑function training. Clinically applied for balance assessment and auxiliary rehabilitation training for stroke, traumatic brain injury, Parkinson’s disease, vestibular dysfunction, elderly fall‑risk screening and post‑orthopedic‑surgery rehabilitation etc. Note: This device is for parameter acquisition and auxiliary training only and shall not be used as sole diagnostic basis.
7、禁忌症 Contraindications
中文
严重骨关节损伤、骨折未愈合，无法维持站立 / 坐姿的患者。
严重骨质疏松、病理性骨折高风险。
重度意识障碍、躁动不能配合测试者。
严重心脑血管急症、未控制重度高血压、不稳定心绞痛等，不适合站立 / 体位转换。
局部皮肤破溃感染，无法接触平台坐垫。
English
Patients with severe bone‑joint injury or unhealed fracture unable to maintain standing or sitting posture.
Severe osteoporosis with high risk of pathological fracture.
Severe conscious disturbance or restlessness who cannot cooperate with test procedure.
Acute severe cardiovascular‑cerebrovascular diseases, uncontrolled severe hypertension, unstable angina pectoris or other conditions unsuitable for standing/posture transition.
Local skin ulceration or infection preventing contact with platｆorm or cushion.
8、注意事项 Precautions
中文
测试全程受试者务必握紧安全扶手，防止跌倒；医护人员全程监护。
仅用于室内临床环境使用，不可用于体外诊断。
设备传感器台面避免硬物撞击、重压；禁止液体泼洒至传感器、接口。
使用环境避免强电磁干扰，远离大功率设备。
定期检查 USB 连接、电源适配器完好；不可使用非原厂适配器。
受试者禁止穿厚底鞋、高跟鞋进行测试。
本设备评估结果仅作临床参考，需结合临床症状综合判断，不可单独作为诊断。
搬运设备时轻拿轻放，避免摔落冲击。
English
Subjects shall grip safety handrails firmly throughout test to prevent fall. Clinical staff shall supervise whole procedure.
For indoor clinical environment only; not for in‑vitro diagnosis.
Avoid hard‑ｏbject impact or heavy load on sensor platｆorm. Prevent liquid spill onto sensors and ports.
Operating environment shall avoid strong electromagnetic interference; keep away from high‑power equipment.
Regularly inspect USB connection and power‑adapter integrity. Do NOT use non‑original adapter.
Subjects shall not wear thick‑soled shoes or high‑heels during testing.
Assessment results are for clinical reference only. Comprehensive judgment shall combine clinical manifestations; shall not be used as sole diagnostic evidence.
Handle device gently during transportation; avoid drop and impact.
9、存储条件 Storage Conditions
中文环境温度：‑10℃～+55℃；相对湿度：10%‑80%，无冷凝；大气压力：70kPa‑106kPa；放置于干燥通风室内，避免日晒雨淋、腐蚀性气体、粉尘堆积；设备断电存放。
EnglishAmbient temperature:‑10℃～+55℃; Relative humidity:10%‑80%, non‑condensing; Atmospheric pressure:70kPa‑106kPa. Store in dry and ventilated indoor location, avoid direct sunlight, rain, corrosive gas and dust accumulation. Store device under power‑off status.
10、说明书核心摘要 Summary of Instructions for Use
中文本产品为二类医疗器械，分为 Balance‑A（站姿 + 坐姿检测）、Balance‑B（站姿检测），由机械支架、压力传感平台、电源适配器、数据线及平衡检测训练软件 V2 组成；通过压力传感器采集人体静态平衡压力中心数据，完成平衡评估与视觉生物反馈康复训练；输出重心摆动相关量化指标，生成报告供临床参考。操作人员需经设备操作培训；测试必须有监护，防范跌倒风险；禁忌症患者禁止使用；设备室内使用，做好防尘防潮；结果仅辅助参考，不单独作为诊断依据。
EnglishThis is Class‑II medical device, including Balance‑A (standing + sitting assessment) and Balance‑B (standing‑only assessment). It consists of mechanical ｆframe, pressure‑sensing platｆorms, power adapter, data cable and Balance Assessment & Training Software V2. It acquires static‑balance COP data via pressure sensors to perｆorm balance assessment and visual‑biofeedback rehabilitation training, outputs quantitative sway indexes and generates reports for clinical reference. Operators shall receive device‑operation training. Supervision is mandatory during test for fall prevention. Contraindicated patients shall not use this device. Operate indoors with dust‑proof and moisture‑proof protection. Test results serve only as auxiliary reference and shall not be taken as sole diagnostic evidence.
免责声明：以上产品详情仅供参考，临床操作请以原厂纸质说明书为准。上海康世达医疗器械有限公司不生产医疗产品，所有产品均来自产品的生产厂家，代理商，经销商，如有侵权请联系我们，会尽快处理！The above product details are for reference only. All clinical operations shall be carried out in strict accordance with the original paper instructions for use issued by the manufacturer.
Shanghai Kangshida Medical Devices Co., Ltd. does not manufacture medical devices. All products are sourced from respective manufacturers, authorized agents and distributors.
Please contact us promptly in case of any infringement, and we will resolve the matter as soon as possible.
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