厂商供应怡和嘉业多导睡眠呼吸监测仪H2,H2 Plus,H2 Elite
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厂商供应怡和嘉业多导睡眠呼吸监测仪H2,H2 Plus,H2 Elite
桂经理19117326863微xin同号
管理类别 第二类
型号规格 H2、H2 Plus、H2 Elite、H2 Pro、YH-S900B、YH-S900C
结构及组成/主要组成成分 H2：H2主机、导联线(胸腹呼吸导联线)、传感器(脉搏血氧饱和度传感器、一次性使用脉搏血氧饱和度传感器(选配)和血氧延长线(选配)、麦克式鼾声传感器、热敏式口鼻气流传感器、胸腹呼吸绑带)、一次性使用鼻氧管或有注册证的其他同类型产品、CPAP压力管、数据传输线(选配)、数据存储卡、PolyHub数据波形显示软件(发布版本：1)、Polypro S1数据分析软件(发布版本：1)
一、工作原理（Working Principle）
中文H2 系列采用多通道生物电传感 + 数字信号采集 + 无线传输 + 智能分析技术，同步捕捉睡眠生理信号：
信号采集：通过血氧、气流、胸腹呼吸、体位、鼾声、心电、脑电、眼电、肌电等传感器，采集微伏级生理信号。
放大滤波：前置放大器与抗干扰滤波，去除肌电、工频、运动伪迹。
模数转换：24 位高分辨率 AD 转换，将模拟信号转为数字信号。
数据传输：内置 WiFi / 蓝牙，实时无线传输至平板 / 电脑，或本地存储卡存储。
分析判读：Polypro 软件按 AASM 标准自动分析睡眠分期、呼吸事件、血氧 desaturation、心率变异，生成诊断报告。
EnglishH2 series uses multi-channel biosensing + digital acquisition + wireless transmission + intelligent analysis:
Signal Capture: Sensors for SpO2, airflow, thoracoabdominal effort, position, snore, ECG, EEG, EOG, EMG collect µV-level signals.
Amplification & Filtering: Preamplifier & noise filtering remove EMG, line noise, motion artifact.
A/D Conversion: 24-bit high-resolution conversion.
Transmission: WiFi/Bluetooth real-time wireless or SD card storage.
Analysis: Polypro software auto-scores sleep stages, respiratory events, desaturation, HRV per AASM; generates reports.
二、产品功能（Functions）
1. 基础监测（H2）
中文
血氧饱和度（SpO2）、脉率、脉搏波
口鼻气流（热敏 + 压力式）、鼾声、胸腹呼吸
体位（仰卧 / 侧卧 / 俯卧）、CPAP 压力监测
实时波形显示、数据存储、自动分析、报告生成
English
SpO2, pulse rate, pulse wave
Nasal/oral airflow (thermal + pressure), snoring, thoracoabdominal effort
Body position, CPAP pressure monitoring
Real-time waveｆorm, data storage, auto-analysis, reporting
2. 增强监测（H2 Plus）
中文
含 H2 全部功能 + 12 导心电（ECG）、心率变异分析
呼吸暂停 / 低通气 / 中枢性 / 混合性事件判别
睡眠呼吸暂停低通气指数（AHI）、氧减指数（ODI）自动计算
English
All H2 functions + 12-lead ECG, HRV analysis
Apnea/hypopnea/central/mixed event classification
AHI, ODI auto-calculation
3. 全功能监测（H2 Elite）
中文
含 H2 Plus 全部功能 + 脑电（EEG）、眼电（EOG）、肌电（EMG / 下巴 + 腿动）
完整睡眠分期（清醒 / 浅睡 / 深睡 / REM）、睡眠结构分析
周期性肢体运动（PLM）、觉醒次数、睡眠效率评估
支持视频 / 音频同步、术中 / 家庭监测、压力滴定
English
All H2 Plus functions + EEG, EOG, EMG (chin + leg)
Full sleep staging (W/N1/N2/N3/REM), sleep architecture
PLM, arousals, sleep efficiency
Video/audio sync, home/OR monitoring, pressure titration
三、产品特点（Features）
中文
三型号分级：H2（基础）、H2 Plus（心电增强）、H2 Elite（全 PSG）
超轻便携：主机约 150g，可佩戴式，无线设计，适合家庭 / 床旁 / 移动
抗干扰强：高共模抑制比（≥80dB）、屏蔽线缆、运动伪迹过滤
双存储模式：本地 SD 卡（≥32G）+ WiFi 实时传输，双备份防丢失
智能软件：Polypro 跨平台（Windows/iOS）、自动判读、AASM 标准、自定义报告
长时续航：内置锂电，连续监测≥12 小时，满足整夜睡眠
临床兼容：适配 CPAP/AutoCPAP/BPAP，支持压力滴定与疗效评估
操作简易：彩色编码导联、一键启动、连接状态自检、APP 远程监控
English
3-Tier Models: H2 (basic), H2 Plus (ECG), H2 Elite (full PSG)
Ultra-Portable: ~150g, wearable, wireless, home/bedside/mobile
High Noise Immunity: CMRR ≥80dB, shielded cables, artifact rejection
Dual Storage: SD card (≥32G) + WiFi real-time, redundant backup
Smart Software: Polypro cross-platｆorm, auto-scoring, AASM, custom reports
Long Battery: ≥12hr continuous, full-night monitoring
Clinical Compatible: Works with CPAP/AutoCPAP/BPAP, titration & efficacy
Easy Use: Color-coded leads, one-key start, self-test, remote APP monitoring
四、技术参数（Specifications）
H2
通道：7 通道（血氧、气流、胸腹、体位、鼾声、CPAP）
血氧：0–100%，脉率 30–250bpm，精度 ±2%
气流：热敏 + 压力，0–160L/min
采样：24 位 AD，2048Hz / 通道
尺寸：121.5×82×21.5mm，约 150g
电源：DC 5V，锂电≥12h
H2 Plus
通道：11 通道（+ECG 4 导）
心电：0.05–150Hz，增益 500–5000 倍
其他：同 H2
H2 Elite
通道：27 通道（+EEG/EOG/EMG 16 导）
脑电：0.1–30Hz，共模抑制比≥100dB
存储：32G SD 卡，存储≥30 天全参数
传输：WiFi 2.4G，蓝牙 5.0
标准：AASM、IEC 60601-1、ISO 80601
五、使用方法（Instructions）
中文
准备
设备：充电≥80%，开机自检，连接传感器
患者：洗头、剃须、无化妆品 / 指甲油，穿宽松前开睡衣
环境：安静、遮光、温度 22–26℃
传感器佩戴
血氧：食指 / 中指，固定牢固
气流：鼻氧管 / 口鼻面罩，胶带固定
呼吸：胸腹绑带松紧适度
Elite：头皮 / 眼周 / 下巴 / 腿部电极，导电膏固定，阻抗 < 5kΩ
启动监测
配对 APP / 电脑，确认信号正常
一键启动，实时观察波形
患者自然入睡，避免干扰
结束与分析
长按关机，拆除传感器
数据同步至软件，自动分析
生成报告，医生判读
English
Preparation
Device: Charge ≥80%, self-test, connect sensors
Patient: Wash hair, shave, no cosmetics/nail polish, loose front-open pajamas
Environment: Quiet, dark, 22–26°C
Sensor Application
SpO2: Index/middle finger, secure
Airflow: Nasal cannula/mask, tape fixed
Effort: Thoracoabdominal belts snug
Elite: Scalp/EOG/chin/leg electrodes, conductive paste, impedance <5kΩ
Start Monitoring
Pair APP/PC, verify signals
One-key start, monitor waveｆorms
Patient sleep undisturbed
Completion & Analysis
Long press power off, remove sensors
Sync data, auto-analysis
Generate report, physician interpretation
六、适应症（Indications）
中文
睡眠呼吸暂停：打鼾、夜间憋气、白天嗜睡、晨起头痛
失眠分型：入睡困难、易醒、早醒、睡眠结构紊乱
中枢睡眠疾病：发作性睡病、不宁腿、周期性肢体运动
心血管合并症：难治性高血压、心律失常、冠心病、脑卒中
代谢疾病：2 型糖尿病、肥胖、代谢综合征
治疗评估：CPAP / 口腔矫治器 / 术后疗效随访
特殊人群：驾驶员、高空作业、孕妇、老年睡眠评估
English
Sleep Apnea: Snoring, apnea, daytime sleepiness, morning headache
Insomnia Subtyping: Difficulty falling/staying asleep, fragmented sleep
Central Disorders: Narcolepsy, RLS, PLM
Cardiovascular: Resistant hypertension, arrhythmia, CAD, stroke
Metabolic: Type 2 diabetes, obesity, ｍmbedbolic syndrome
Treatment Follow-Up: CPAP/oral appliance/post-surgery efficacy
Special Groups: Drivers, high-altitude workers, pregnancy, elderly
七、禁忌症（Contraindications）
中文
绝对禁忌
对电极 / 血氧探头材料严重过敏
头皮 / 皮肤破损、感染、溃疡（电极区）
无法耐受传感器束缚、剧烈躁动不配合
相对禁忌（慎用）
严重呼吸衰竭 / 心力衰竭 / 肝肾功能不全（病情稳定后）
癫痫发作期、精神异常、意识障碍（需监护）
多汗、皮肤潮湿（信号失真风险）
一氧化碳中毒、高铁血红蛋白血症（影响血氧准确性）
English
Absolute
Severe allergy to electrodes/SpO2 materials
Scalp/skin breakdown, infection, ulcers
Severe agitation/non-cooperation with sensors
Relative (Caution)
Severe respiratory/cardiac/renal/hepatic failure (stable first)
Active seizures, psychiatric disorders, altered mental status (monitor)
Profuse sweating, moist skin (signal artifact)
CO poisoning, methemoglobinemia (SpO2 inaccuracy)
八、注意事项（Precautions）
中文
监测前
禁酒精、、镇静剂 24 小时（遵医嘱）
白天不午睡，保持正常作息
电极部位清洁去角质，保证低阻抗
监测中
传感器牢固不松动，避免牵拉线缆
禁止手机 / 电器靠近，防电磁干扰
患者自然睡眠，勿刻意调整姿势
监测后
温和拆除电极，清洁皮肤
设备清洁消毒（75% 酒精）
数据及时备份，防止丢失
设备维护
每月充电校准，传感器定期更换
软件定期更新，适配新标准
防摔、防潮、防尘、防高温
English
Pre-Test
No alcohol/caffeine/sedatives 24hr (per MD)
No daytime naps, maintain routine
Clean/exfoliate electrode sites for low impedance
During Test
Sensors secure, no cable tension
Keep phones/electronics away (EMI)
Patient sleep naturally, no forced positioning
Post-Test
Remove electrodes gently, clean skin
Disinfect device (75% alcohol)
Backup data promptly
Maintenance
Charge/calibrate monthly, replace sensors regularly
Update software for new standards
Protect from shock, moisture, dust, heat
九、存储条件（Storage）
中文
温度：-10℃～+50℃（运输）；+5℃～+35℃（长期）
湿度：30%～75% RH（无冷凝）
环境：干燥、通风、清洁、无阳光直射、无腐蚀性气体
摆放：水平放置，避免挤压、弯折线缆
防护：防尘罩、防潮、防鼠、防尖锐物
电池：长期存储（>3 个月）充满电取出，单独阴凉保存
耗材：电极 / 传感器密封干燥，有效期内使用
English
Temperature: -10°C to +50°C (shipping); +5°C to +35°C (storage)
Humidity: 30–75% RH (non-condensing)
Environment: Dry, ventilated, clean, no direct sun, no corrosive gases
Position: Flat, no cable crushing/bending
Protection: Dust cover, moisture, rodents, sharp ｏbjects
Battery: Remove & fully charge if stored >3 months
Consumables: Sealed dry electrodes/sensors, use before expiry
十、说明书核心信息（Manual Summary）
中文
名称：多导睡眠呼吸监测仪
型号：H2、H2 Plus、H2 Elite
分类：二类医疗器械（6821 医用电子仪器）
注册证：国械注准 XXXXXXXX
组成：主机、传感器、导联线、软件、配件
用途：睡眠呼吸暂停、失眠、中枢睡眠疾病诊断与治疗评估
适用：医院睡眠中心、呼吸科、耳鼻喉科、神经内科、家庭筛查
用户：医生、技师、经培训患者 / 家属
保修：1 年（耗材 / 人为损坏除外）
标准：AASM 2.3、IEC 60601、ISO 80601
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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