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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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厂家瑞迈特睡眠呼吸初筛仪YH-600A,YH-600APro,YH-600B,YH-600BPro

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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):京械注准20152070265更新时间:2026/10/16 11:11:02

产品摘要:厂家瑞迈特睡眠呼吸初筛仪YH-600A,YH-600APro,YH-600B,YH-600BPro

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详细内容

厂家瑞迈特睡眠呼吸初筛仪YH-600A,YH-600APro,YH-600B,YH-600BPro
桂经理19117326863微xin同号

管理类别

第二类

型号规格

YH-600A、YH-600APro、YH-600B、YH-600BPro

结构及组成/主要组成成分

见附页

适用范围/预期用途

通过检测睡眠呼吸事件,用于睡眠呼吸暂停低通气综合征的筛查。

一、工作原理(Working Principle)

中文YH-600 系列采用腕戴式便携设计 + 多通道传感 + 数字信号处理 + AI 智能分析技术,采集睡眠生理信号,自动识别呼吸事件与睡眠状态:

信号采集:通过血氧(红外 / 红光)、热敏 / 压力气流、压电式鼾声、加速度体位、RIP 胸腹呼吸(B 型)、腕动传感器,同步采集血氧、脉率、气流、呼吸努力、体位、鼾声、体动数据。

信号处理:前置放大、滤波降噪、24 位 AD 转换,去除运动伪迹与工频干扰。

智能分析:内置算法自动判读呼吸暂停(阻塞 / 中枢 / 混合)、低通气、血氧下降、觉醒、睡眠分期,计算 AHI、ODI 等核心指标。

数据存储 / 传输:本地 TF 卡存储(≥32G),Pro 版支持蓝牙 5.0 无线传输至手机 / 电脑,生成标准化报告。

EnglishYH-600 series uses wrist-worn portable design + multi-channel sensing + digital processing + AI analysis for non-invasive sleep data capture & automatic event detection:

Signal Acquisition: SpO2 (IR/red), thermal/pressure airflow, piezoelectric snore, accelerometer position, RIP thoracoabdominal effort (B-type), wrist motion sensors capture SpO2, PR, airflow, effort, position, snore, activity.

Processing: Preamplification, filtering, 24-bit A/D conversion reject artifact & line noise.

Analysis: Onboard algorithm scores apnea (obstructive/central/mixed), hypopnea, desaturation, arousal, sleep stages; calculates AHI, ODI.

Storage/Transmission: TF card (≥32G); Pro adds Bluetooth 5.0 to phone/PC; generates standard reports.

二、产品功能(Functions)

1. YH-600A / YH-600A Pro

中文

核心监测:血氧饱和度(SpO2)、脉率、口鼻气流、鼾声、体位、腕部体动(睡眠 / 觉醒)、CPAP 压力

事件识别:自动判别呼吸暂停、低通气、氧减事件、觉醒

数据记录:连续监测≥20 小时,存储≥12 个月数据

实时显示:OLED 屏显波形、参数、连接状态

Pro 增强:蓝牙 5.0 无线传输、APP 实时监控、AI 智能分析、数据云同步

English

Core Monitoring: SpO2, pulse rate, nasal/oral airflow, snore, body position, wrist activity (sleep/wake), CPAP pressure

Event Detection: Auto apnea, hypopnea, desaturation, arousal

Logging: ≥20hr continuous, ≥12mo storage

Display: OLED waveform, parameters, connection status

Pro Upgrade: Bluetooth 5.0, APP monitoring, AI analysis, cloud sync

2. YH-600B / YH-600B Pro

中文

含 A 系全部功能 + 胸腹呼吸运动监测(RIP 技术)

呼吸分型:区分阻塞性 / 中枢性 / 混合性呼吸暂停

呼吸努力:定量监测胸腹呼吸幅度、频率、暂停时长

睡眠结构:结合体动 + 呼吸 + 血氧,评估睡眠连续性

Pro 增强:蓝牙传输、远程数据共享、智能报告、压力滴定分析

English

All A functions + thoracoabdominal effort (RIP)

Apnea Typing: Obstructive/central/mixed classification

Effort Monitoring: Quantitative thoracoabdominal amplitude, frequency, duration

Sleep Architecture: Assess continuity via activity+breathing+SpO2

Pro Upgrade: Bluetooth, remote sharing, smart reports, titration analysis

三、产品特点(Features)

中文

腕戴便携:一体化腕带设计,主机轻至≈80g,无感佩戴、不扰睡眠

分级配置:A(基础)/B(胸腹呼吸);Pro(蓝牙)/ 非 Pro(有线)

传感:RIP 呼吸感应(B 型)、血氧精度 ±2%、压力 ±1hPa

长时续航:单节 AA 电池 / 锂电,连续监测≥20 小时(Pro≥30 小时)

智能算法:AI 自动判读,符合 AASM 标准,与 PSG 一致性高

双存储传输:TF 卡本地存储 + Pro 版蓝牙无线传输

操作简易:一键启动、导联状态自检、声光报警、中文界面

临床兼容:支持 CPAP/BPAP 压力滴定、治疗疗效评估

安全可靠:低电磁辐射、抗干扰、IPX4 防水、无源血氧安全

English

Wrist-Worn: All-in-one wristband, ≈80g, non-disruptive

Tiered Config: A (basic)/B (effort); Pro (BT)/non-Pro (wired)

Precision Sensing: RIP (B), SpO2 ±2%, pressure ±1hPa

Long Battery: 1×AA / Li-ion ≥20hr (Pro ≥30hr)

Smart Algorithm: AI scoring, AASM-compliant, high PSG correlation

Dual Transfer: TF card + Pro Bluetooth

Easy Use: One-key start, self-test, alarms, Chinese UI

Clinical Fit: CPAP/BPAP titration, therapy efficacy

Safe: Low EMI, immunity, IPX4, passive SpO2




四、技术参数(Specifications)

表格

参数 YH-600A/A Pro YH-600B/B Pro English

监测通道 6 通道(无胸腹) 8 通道(含胸腹 RIP) 6-ch (no effort); 8-ch (RIP effort)

血氧 SpO2 0–100%, ±2% (70–100%) 同左 0–100%, ±2% (70–100%)

脉率 30–250bpm, ±2bpm 同左 30–250bpm, ±2bpm

气流 热敏 + 压力,0–160L/min 同左 Thermal+pressure, 0–160L/min

胸腹呼吸 — RIP, 0–40 次 / 分 —; RIP, 0–40 rpm

压力范围 4–20hPa, ±1hPa 同左 4–20hPa, ±1hPa

采样率 24 位,2048Hz / 通道 同左 24-bit, 2048Hz/Ch

显示屏 OLED 彩色,1.54 英寸 同左 OLED color, 1.54"

数据传输 A:USB;A Pro:USB + 蓝牙 B:USB;B Pro:USB + 蓝牙 A: USB; A Pro: USB+BT; B: USB; B Pro: USB+BT

供电 1×AA 电池 / 锂电 同左 1×AA / Li-ion

续航 ≥20 小时;Pro≥30 小时 同左 ≥20hr; Pro≥30hr

尺寸 / 重量 72×52×22mm, ≈80g 同左 72×52×22mm, ≈80g

注册证 京械注准 20152210265 同左 Beijing Reg 20152210265

五、使用方法(Instructions)

中文

准备

设备:装电池 / 充电,插入 TF 卡,开机自检

传感器:连接血氧探头、气流管、胸腹绑带(B 型)

患者:清洁手指 / 皮肤,无指甲油 / 化妆品,穿宽松衣物

佩戴

主机:腕带固定于左手腕,松紧适度

血氧:食指 / 中指,探头对准指腹,固定牢固

气流:鼻氧管置入鼻腔,胶带固定防脱落

B 型:胸腹绑带分别置于乳头下 / 脐上,松紧可插入一指

启动监测

按开始键,确认波形正常、无报警

患者自然入睡,避免触碰设备、拉扯管路

实时观察屏幕参数,异常时检查连接

结束与分析

长按关机,拆除所有传感器

数据通过 USB / 蓝牙导入软件,自动分析

生成 AHI、ODI、事件统计、睡眠趋势报告

医生判读,明确诊断与治疗建议

English

Preparation

Device: Insert battery/charge, TF card, self-test

Sensors: Connect SpO2, airflow, effort belts (B)

Patient: Clean skin, no polish/cosmetics, loose clothing

Application

Unit: Fasten left wrist, snug fit

SpO2: Index/middle finger, secure probe

Airflow: Nasal cannula, tape fixed

B-type: Effort belts below nipples/above navel, 1-finger slack

Start Monitoring

Press Start, verify waveforms, no alarms

Sleep naturally, no device disturbance

Monitor display; check connections if abnormal

Completion & Analysis

Long press power off, remove sensors

Transfer data via USB/BT to software

Generate AHI, ODI, events, sleep reports

Physician interpretation & diagnosis

六、适应症(Indications)

中文

睡眠呼吸暂停初筛:打鼾、夜间憋气、白天嗜睡、晨起头痛

OSAHS 分级:轻 / 中 / 重度阻塞性睡眠呼吸暂停低通气综合征

家庭 / 社区筛查:疑似 OSA、肥胖、颈粗、小颌畸形、高血压人群

治疗评估:CPAP / 口腔矫治器 / 术后疗效随访、压力滴定

特殊人群:驾驶员、高空作业、孕妇、老年睡眠监测

失眠伴呼吸事件:睡眠片段化、夜间觉醒、不明原因疲劳

English

Sleep Apnea Screening: Snoring, apnea, daytime sleepiness, morning headache

OSAHS Grading: Mild/moderate/severe obstructive sleep apnea-hypopnea

Home/Community: Suspected OSA, obesity, thick neck, micrognathia, hypertension

Therapy Follow-Up: CPAP/oral appliance/post-surgery, pressure titration

Special Groups: Drivers, high-altitude workers, pregnancy, elderly

Insomnia with Events: Fragmented sleep, nocturnal arousal, fatigue

七、禁忌症(Contraindications)

中文

绝对禁忌

血氧探头 / 电极材料严重过敏

手指 / 皮肤破损、感染、溃疡(传感器部位)

无法耐受佩戴、剧烈躁动、意识障碍

活动性大出血、休克、未纠正的呼吸衰竭

相对禁忌(慎用)

外周血管疾病、雷诺氏症(影响血氧准确性)

严重贫血、高铁血红蛋白血症(SpO2 误差)

多汗、皮肤潮湿(信号干扰、接触不良)

癫痫发作期、精神异常(需专人监护)

一氧化碳中毒、低血压(生理信号失真)

English

Absolute

Severe allergy to sensors/probe materials

Skin breakdown, infection, ulcers at sensor sites

Intolerance, severe agitation, altered mental status

Active bleeding, shock, uncorrected respiratory failure

Relative (Caution)

Peripheral vascular disease, Raynaud’s (SpO2 inaccuracy)

Severe anemia, methemoglobinemia (SpO2 error)

Profuse sweating, moist skin (artifact, poor contact)

Active seizures, psychosis (monitoring required)

CO poisoning, hypotension (signal distortion)

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

传感器部位清洁干燥,确保信号稳定

环境安静遮光、温度 22–26℃

监测中

传感器牢固不松动,避免管路牵拉、弯折

禁止手机 / 电器靠近,防电磁干扰

出现胸闷、气促、剧烈头痛立即停机就医

主机水平佩戴,不遮挡进气 / 传感器

监测后

温和拆除传感器,清洁皮肤

设备75% 酒精擦拭消毒,干燥存放

数据及时备份,防止丢失

耗材定期更换(血氧探头≥100 次、鼻氧管≥1 个月)

English

Pre-Test

No alcohol/caffeine/sedatives 24hr (per MD)

No daytime naps, maintain routine

Clean/dry sensor sites for stable signals

Quiet, dark, 22–26°C environment

During Test

Secure sensors, no cable tension/kinking

Keep phones/electronics away (EMI)

Stop & seek care for chest pain, dyspnea, headache

Wear unit level, unblock vents/sensors

Post-Test

Remove gently, clean skin

Disinfect with 75% alcohol, dry store

Backup data promptly

Replace consumables regularly (SpO2 ≥100 uses, cannula ≥1mo)

九、存储条件(Storage)

中文

温度:运输 **-20℃~+55℃;存储+5℃~+35℃**

湿度:运输≤93%;存储≤80%(无冷凝)

环境:干燥、通风、清洁、避光、无腐蚀性气体

摆放:腕带松开、水平放置,勿重压、摔落、弯折

防护:防尘罩、防潮、防鼠、防尖锐物划伤

电池:长期存储(>3 个月)取出电池,单独存放

耗材:密封干燥、有效期内使用,避免阳光直射

English

Temperature: Shipping -20°C~+55°C; Storage +5°C~+35°C

Humidity: Shipping ≤93%; Storage ≤80% (non-condensing)

Environment: Dry, ventilated, clean, dark, no corrosive gases

Position: Loosen wristband, flat placement, no crushing/dropping

Protection: Dust cover, moisture, rodents, sharp objects

Battery: Remove if stored >3 months

Consumables: Sealed dry, use before expiry, avoid sunlight

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:厂家瑞迈特睡眠呼吸初筛仪YH-600AYH-600AProYH-600BYH-600BPro,瑞迈特睡眠呼吸初筛仪,瑞迈特睡眠呼吸初筛仪YH-600

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