厂家供应艾信诺大牧睡眠呼吸初筛仪DM-5200A
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厂家供应艾信诺大牧睡眠呼吸初筛仪DM-5200A
桂经理19117326863微xin同号
管理类别
第二类
型号规格
DM-5200A
结构及组成/主要组成成分
产品由主机、附件、睡眠呼吸数据判读和分析软件组成，主机由外壳、显示屏、按键、电路板、腕带组成，附件包括血氧指套、胸腹呼吸带、胸腹呼吸带导联线、鼻氧管。
适用范围/预期用途
通过检测睡眠时的生理参数，使用分析软件对生理参数进行人工判读（手动分析标记睡眠呼吸事件）并生成报告，供睡眠呼吸暂停低通气综合征的筛查用。本产品无睡眠呼吸事件类型自动分析及初步诊断功能。
一、工作原理（Working Principle）
中文
DM-5200A 为腕戴式多生理信号便携初筛设备，核心原理是通过多传感器同步采集睡眠期呼吸与血氧相关参数，经预处理后存储数据，由专用软件人工判读呼吸事件，实现睡眠呼吸暂停低通气综合征的初筛。
信号采集：鼻气流传感器检测口鼻气流变化；胸腹呼吸带（RIP）采集呼吸努力与胸腹运动；血氧指套实时监测 SpO?与脉率；体动传感器记录睡眠体动；麦克风辅助检测鼾声。
信号处理：内置高速处理器对原始信号进行滤波、去噪与基线校正，转换为标准化波形与数值。
数据存储：以加密格式存储采集参数，支持长时间连续记录。
人工判读：通过专用软件回放数据，由专业人员手动标记呼吸暂停、低通气、血氧下降等事件，计算相关指标以完成初筛。
English
DM-5200A is a wrist-worn portable screening device for multi-physiological signals. Its core principle is synchronous acquisition of sleep-related respiratory and SpO? parameters via multiple sensors, preprocessing and storage of data, and manual interpretation of respiratory events by dedicated software to screen for sleep apnea-hypopnea syndrome.
Signal Acquisition: Nasal airflow sensor detects airflow changes; respiratory inductance plethysmography (RIP) captures respiratory effort and thoracoabdominal movement; SpO? finger cuff monitors SpO? and pulse rate in real time; body movement sensor records sleep activity; microphone assists snoring detection.
Signal Processing: Built-in high-speed processor filters, denoises, and corrects baselines for raw signals, converting to standardized waveｆorms and values.
Data Storage: Encrypted ｆormat for long-term continuous recording.
Manual Interpretation: Dedicated software for data review; professionals manually mark apnea, hypopnea, desaturation, etc., calculate relevant metrics for initial screening.
二、产品功能（Functions）
中文
多参数同步监测：口鼻气流、胸腹呼吸努力、SpO?/ 脉率、体动、鼾声，覆盖初筛核心指标。
实时数据显示：OLED 屏实时查看呼吸、血氧、体动等关键参数，监测状态可视化。
数据存储与导出：大容量存储夜间监测数据，支持通过 USB / 蓝牙导出至电脑。
人工判读工具：专用软件支持波形回放、参数对比、事件手动标记、报告生成与打印。
腕戴便携设计：一体化主机 + 腕带，轻量化（约 75g），适合家庭 / 门诊非卧床环境监测。
基础质控：导联连接与传感器状态提示，辅助确保数据有效性。
English
Synchronous Multi-Parameter Monitoring: Nasal airflow, respiratory effort, SpO?/pulse rate, body movement, snoring – core screening indicators.
Real-Time Display: OLED screen for real-time key parameters (respiration, SpO?, movement) with visual monitoring status.
Data Storage & Export: Large-capacity storage for overnight data; USB / 蓝牙 export to PC.
Manual Review Tools: Dedicated software for waveｆorm playback, parameter comparison, manual event marking, report generation/printing.
Wrist-Worn Portable: All-in-one host + wristband, lightweight (~75g) for home/clinic non-bedside monitoring.
Basic Quality Control: Lead connection and sensor status prompts to ensure data validity.
三、产品特点（Product Features）
中文
便捷：腕戴式佩戴，操作简单，无需专业安装，适合居家 / 门诊场景。
核心参数覆盖：聚焦呼吸与血氧关键初筛指标，满足中重度 OSA 筛查需求。
人工判读合规：符合临床初筛规范，结果需专业人员人工复核，保障准确性。
低功耗长续航：内置可充电电池，支持≥8 小时连续监测，满足整夜监测。
抗干扰设计：滤波算法降低环境与运动伪迹，提升数据可靠性。
安全可靠：二类医疗器械认证，材质生物相容，使用风险低。
English
Non-Invasive & Convenient: Wrist-worn design, simple operation, no professional installation required for home/clinic use.
Core Parameter Coverage: Focuses on key respiratory and SpO? indicators for moderate-severe OSA screening.
Compliant Manual Review: Follows clinical screening protocols; results require professional review for accuracy.
Low-Power Long Battery Life: Rechargeable battery supports ≥8 hours of continuous monitoring for overnight studies.
Anti-Interference Design: Filtering algorithms reduce environmental/motion artifacts for reliable data.
Safe & Reliable: Class II medical device certification, biocompatible materials, low risk.
四、技术参数（Technical Specifications）
表格
参数项（Parameter） 规格（Specification） 英文（English）
产品名称 睡眠呼吸初筛仪 Sleep Respiratory Screening Device
型号 DM-5200A DM-5200A
管理类别 第二类医疗器械 Class II Medical Device
注册证号 浙械注准 20222071070 Registration No.: Zhejiang Medical Registration 20222071070
监测参数 口鼻气流、胸腹呼吸努力、SpO?、脉率、体动、鼾声 Nasal Airflow, Respiratory Effort, SpO?, Pulse Rate, Body Movement, Snoring
血氧范围 / 精度 25%–100% SpO?；±2%（或 ±3%） SpO? Range/Accuracy: 25–100%; ±2% (or ±3%)
采样率 呼吸 / 血氧：≥100 Hz；体动 / 鼾声：≥50 Hz Sampling Rate: Resp/SpO? ≥100 Hz; Movement/Snore ≥50 Hz
存储容量 ≥8 小时连续监测数据（≥16GB） Storage Capacity: ≥8 hours (~16GB)
显示 0.96 英寸 OLED 屏 0.96" OLED Screen
供电 可充电锂电池，Type-C 充电 Rechargeable Li-Battery, Type-C Charging
续航 ≥8 小时（监测模式） Battery Life: ≥8 hours (Monitoring Mode)
尺寸 / 重量 主机约 60×40×15 mm；约 75g（含腕带） Dimensions/Weight: ~60×40×15 mm; ~75g (with wristband)
工作环境 温度 10℃–35℃；湿度 30%–80% RH（无冷凝） Operating Environment: 10–35°C; 30–80%RH (non-condensing)
存储环境 温度 - 20℃–50℃；湿度 30%–95% RH（无冷凝） Storage Environment: -20–50°C; 30–95%RH (non-condensing)
五、使用方法（Operation Method）
中文
准备与佩戴
检查主机、血氧指套、胸腹呼吸带、鼻氧管、导联线等配件是否齐全。
清洁患者皮肤（胸腹、鼻部、手指），避免油脂 / 汗液影响传感器。
主机佩戴于非惯用手手腕；胸腹呼吸带固定于胸部 / 腹部；鼻氧管贴合鼻翼；血氧指套套于食指。
参数设置
开机后选择 “监测模式”，确认监测时长（默认≥7 小时）。
检查导联连接与传感器状态，确保无松动 / 脱落。
开始监测
确认患者状态（避免饮酒 / ），启动记录，设备自动采集数据。
夜间巡视 1–2 次，检查设备佩戴与信号，及时处理脱落 / 故障。
数据导出与判读
次日结束监测，通过 USB / 蓝牙将数据导出至电脑。
用专用软件回放波形，手动标记呼吸暂停、低通气、血氧下降等事件。
生成含事件统计、SpO?趋势等内容的报告，供临床初筛参考。
设备收尾
撤除传感器，清洁消毒配件（75% 酒精擦拭），主机充电备用。
English
Preparation & Application
Check completeness of host, SpO? cuff, RIP belt, nasal cannula, lead wires.
Clean patient’s skin (chest/abdomen, nose, fingers) to avoid oil/sweat interference.
Wear host on non-dominant wrist; secure RIP belt to chest/abdomen; fit nasal cannula to nostril; attach SpO? cuff to index finger.
Setup
Power on, select monitoring mode, confirm duration (default ≥7 hours).
Verify lead connections and sensor status for no looseness/detachment.
Start Monitoring
Confirm patient status (no alcohol/caffeine), start recording; device auto-acquires data.
Overnight check 1–2 times to ensure 佩戴 and signal quality; fix detachment/faults promptly.
Data Export & Review
Stop monitoring next day, export data to PC via USB / 蓝牙.
Use dedicated software for waveｆorm playback; manually mark apnea, hypopnea, desaturation.
Generate report with event statistics, SpO? trends for clinical screening.
Post-Use
Remove sensors, clean/disinfect accessories (75% alcohol wipe), charge host.
六、适应症（Indications）
中文
疑似睡眠呼吸暂停低通气综合征（OSAHS）：夜间打鼾伴呼吸暂停、憋醒、白天嗜睡乏力者。
心血管疾病合并睡眠障碍：高血压、冠心病、心律失常等患者，需排查睡眠呼吸问题。
肥胖人群：BMI≥28，伴打鼾或夜间缺氧风险者。
不明原因夜间症状：夜间憋闷、晨起头痛、口干、记忆力下降者。
鼻部疾病：鼻中隔偏曲、鼻息肉等上气道阻塞相关打鼾者。
治疗随访：OSA 患者接受 CPAP / 手术 / 药物治疗后，疗效初筛与病情监测。
English
Suspected Obstructive Sleep Apnea-Hypopnea Syndrome (OSAHS): Snoring with apnea, awakening, daytime somnolence/fatigue.
Cardiovascular Comorbidities: Hypertension, coronary heart disease, arrhythmias – screen for sleep-related respiratory issues.
Obese Population: BMI≥28 with snoring/nighttime hypoxia risk.
Unexplained Night Symptoms: Nocturnal dyspnea, morning headache, dry mouth, memory decline.
Nasal Disorders: Deviated nasal septum, nasal polyps – screen for upper airway obstruction-related snoring.
Treatment Follow-Up: Initial screening and monitoring for OSA patients post-CPAP/surgery/medication.
七、禁忌症（Contraindications）
中文
绝对禁忌
佩戴部位（胸腹、手指、鼻部）皮肤严重感染 / 破损 / 溃疡，无法固定传感器。
对设备材质（PVC/TPU/TPE/ABS）或导电胶严重过敏，可能引发接触性皮炎 / 过敏反应。
生命体征极不稳定、需紧急抢救，监测会干扰急救且无临床意义。
相对禁忌（慎用）
严重凝血功能障碍 / 出血倾向，电极 / 传感器固定可能增加出血风险。
重度精神 / 认知障碍、躁动、不合作，无法配合佩戴，信号质量差。
严重慢性阻塞性肺疾病（COPD）伴呼吸衰竭，监测可能延误呼吸支持。
English
Absolute Contraindications
Severe skin infection/wounds on application sites (chest/abdomen, fingers, nose) – unable to secure sensors.
Severe allergy to device materials (PVC/TPU/TPE/ABS) or conductive gel – risk of contact dermatitis/anaphylaxis.
Hemodynamically unstable patients requiring emergency care – monitoring interferes with resuscitation and has no clinical value.
Relative Contraindications (Caution)
Severe coagulopathy/bleeding tendency – sensor placement may increase bleeding risk.
Severe cognitive/psychiatric disorder, agitation, non-cooperation – poor signal quality due to inability to comply.
Severe COPD with respiratory failure – monitoring may delay respiratory support.
八、注意事项（Precautions）
中文
人员资质：由经培训的医护人员指导使用与判读，非专业人员不得操作 / 出具报告。
患者准备：监测前洗头、洗澡、剪指甲；避免饮酒、咖啡 / 浓茶、安眠药；保持规律作息。
数据质量：确保导联 / 传感器连接牢固，阻抗匹配；监测中避免剧烈活动 / 翻身脱落，保证数据有效。
判读规范：自动分析仅作参考，所有呼吸事件必须人工 100% 复核后出具初筛报告。
安全防护：监测中关注患者血氧与呼吸，出现严重低氧（SpO?<80% 持续≥1 分钟）、呼吸暂停≥30 秒立即处理。
数据管理：原始数据加密存储、备份≥15 年，严禁篡改；报告需标注 “初筛结论，不能替代 PSG”。
设备维护：定期清洁消毒配件，避免摔落 / 进水；主机避免高温、潮湿、强电磁干扰。
English
Qualified Personnel: Trained clinicians guide use and interpretation; untrained personnel shall not operate or issue reports.
Patient Preparation: Shampoo, bathe, trim nails before monitoring; avoid alcohol, caffeine/tea, sedatives; maintain regular 作息.
Data Quality: Ensure secure lead/sensor connections with matching impedance; prevent detachment during movement for valid data.
Review Standards: Auto-analysis is preliminary; all respiratory events require 100% manual review before issuing screening reports.
Safety Monitoring: Monitor SpO? and respiration; manage severe desaturation (SpO?<80% ≥1 min) or apnea ≥30 sec immediately.
Data Governance: Encrypted storage/backup ≥15 years; no tampering; reports must state “initial screening, not a substitute for PSG”.
Device Maintenance: Regularly clean/disinfect accessories; avoid drops/water exposure; protect from high temperature, humidity, EMI.
九、存储条件（Storage Conditions）
中文
设备存储
主机：温度 - 20℃~+50℃，湿度 30%~95% RH（无冷凝），干燥、避光、防尘、防摔、防磁。
配件（血氧指套、胸腹呼吸带、导联线）：清洁干燥，避免拉伸 / 老化，密封存放于阴凉处。
软件与报告：电脑 / 服务器温度 15℃~25℃，湿度 40%~60% RH，UPS 供电、防雷、数据加密备份。
有效期：设备自批准日起5 年（注册证有效期至 2027-08-17），配件按使用说明定期更换。
English
Device Storage
Host: -20°C to +50°C, 30–95%RH (non-condensing), dry, dark, dust/shock/magnetic-proof.
Accessories (SpO? cuff, RIP belt, leads): Clean/dry, avoid stretching/aging, seal in cool storage.
Software & Reports: PC/server 15–25°C, **4
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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