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厂家供应迈心诺EMMA野马呼末二氧化碳监测仪Radius PCG
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厂家供应迈心诺EMMA野马呼末二氧化碳监测仪Radius PCG
桂经理19117326863微xin同号
管理类别
第二类
型号规格
Radius PCG
结构及组成/主要组成成分
产品由Radius PCG传感器、一次性EMMA气道适配器（成人/小儿型、婴幼儿型）组成。
适用范围/预期用途
该产品用于在麻醉、恢复和呼吸护理期间测量、显示并监测二氧 化碳分压和呼吸频率。此设备可在手术室、重症监护室、病房、 门诊部、急救给药和急救转运环境下用于成人、小儿及婴幼儿患 者。
一、工作原理 (Working Principle)
中文
Radius PCG 采用主流式红外光谱分析技术，基于 CO? 对 4.26 µm 近红外光的特征吸收原理。传感器串联于呼吸回路，内置红外光源发射特定波长光穿过气体腔室，探测器接收透射光强；CO? 浓度与光强衰减程度呈正比，设备据此实时计算 ** 呼末二氧化碳分压（EtCO?）** 与呼吸频率（RR），并生成连续 EtCO? 波形，15 秒内完成显示Masimo。无需常规校准，预热时间短，适配全年龄段患者Masimo。
英文
Radius PCG employs mainstream infrared spectroscopy based on the characteristic absorption of 4.26 µm near-infrared light by CO? molecules. The sensor is inline in the breathing circuit; an internal IR source emits light through the gas chamber, and a detector measures transmitted light intensity. CO? concentration is proportional to light attenuation, enabling real-time calculation of end-tidal CO? (EtCO?) and respiratory rate (RR), with continuous EtCO? waveｆorms displayed within 15 secondsMasimo. No routine calibration is required, with minimal warm-up time, suitable for patients of all agesMasimo.
二、功能 (Functions)
中文
核心监测：实时显示 EtCO?（0–99 mmHg / 0–9.9 kPa）、RR（0–150 bpm）及完整 EtCO? 波形。
快速响应：15 秒内完成测量与波形显示，助力气道管理与复苏评估Masimo。
趋势存储：支持最长 96 小时趋势回顾，辅助通气策略优化Masimo。
智能报警：提供无适配器、适配器堵塞、无呼吸（窒息）、低电量、零点调整及可调节 EtCO? 高低限的声光报警Masimo。
无线互联：蓝牙快速连接 Masimo Root? 平台，实现波形放大、数据上传与电子无缝对接Masimo。
一键操作：简洁界面支持快速设置与单触编程，便携易存于抢救车Masimo。
英文
Core Monitoring: Real-time display of EtCO? (0–99 mmHg / 0–9.9 kPa), RR (0–150 bpm), and full EtCO? waveｆorm.
Fast Response: Accurate measurement and waveｆorm display within 15 seconds to aid airway management and resuscitation assessmentMasimo.
Trend Storage: Up to 96-hour trend review to support ventilation strategy optimizationMasimo.
Smart Alarms: Audible/visual alerts for no adapter, clogged adapter, apnea, low battery, zero point adjustment, and adjustable EtCO? high/low limitsMasimo.
Wireless Connectivity: Bluetooth pairing with Masimo Root? for enlarged waveｆorms, data upload, and seamless EHR integrationMasimo.
One-Touch Operation: Intuitive interface for quick setup and one-touch programming; compact for storage in a crash cartMasimo.
三、产品特点 (Features)
中文
无线主流式：无线缆设计，减少呼吸回路牵拉风险，适配院内转运、急诊、手术室等多场景Masimo。
小巧轻便：尺寸 52×44×39 mm，重量＜65 g（含电池），单手可持，易部署。
低死腔：成人 / 儿童款 6 mL，婴儿款 1 mL，减少呼吸死腔，适配小儿与精细通气需求。
长续航：两节 AAA 锂电池供电，续航最长 10 小时；碱性电池 8 小时，支持边充边用。
免校准维护：无需常规校准，降低日常维护成本，提升临床效率Masimo。
强适配性：兼容 EMMA? 成人 / 儿童 / 婴儿气道适配器，覆盖全年龄段气道管理Masimo。
抗干扰：适配高频电刀等临床设备，信号稳定可靠。
英文
Wireless Mainstream: Cable-free design reduces circuit tug risk, ideal for patient transfer, emergency, OR, and other clinical settingsMasimo.
Compact & Lightweight: 52×44×39 mm, <65 g (with batteries); handheld and easy to deploy.
Low Dead Space: 6 mL for adult/pediatric, 1 mL for infant; minimizes respiratory dead space for pediatric and precise ventilation needs.
Long Battery Life: Two AAA lithium batteries for up to 10 hours; 8 hours with alkaline batteries; supports pass-through charging.
Calibration-Free Maintenance: No routine calibration required, reducing upkeep costs and clinical workloadMasimo.
Full Age Adaptability: Compatible with EMMA? adult/pediatric/infant airway adapters for comprehensive airway managementMasimo.
Interference Resistant: Reliable perｆormance with high-frequency electrosurgical devices; stable signal in complex clinical environments。
四、技术参数 (Specifications)
表格
参数项 (Parameter) 数值 / 说明 (Value/Spec) 中文说明 (Chinese Note)
监测参数 (Monitored Params) EtCO?、RR、EtCO? 波形 呼末二氧化碳、呼吸频率、波形
测量范围 (Measuring Range) EtCO?: 0–99 mmHg / 0–9.9 kPa；RR: 0–150 bpm 覆盖临床常见范围
测量精度 (Accuracy) 0–40 mmHg: ±2 mmHg；41–99 mmHg: 6% 读数；0–5.3 kPa: ±0.3 kPa；5.4–9.9 kPa: 6% 读数；RR: ±1 bpm 标准条件下度
响应时间 (Response Time) ≤15 秒 快速显示测量与波形
死腔 (Dead Space) 成人 / 儿童: 6 mL；婴儿: 1 mL 低死腔设计
无线连接 (Wireless) 蓝牙 ? 连接 Masimo Root? 平台
电池续航 (Battery Life) 锂电池: 10 小时；碱性电池: 8 小时 两节 AAA 电池供电
尺寸 / 重量 (Size/Weight) 52×44×39 mm / ＜65 g（含电池） 便携小巧
工作温度 (Operating Temp) 5–50℃（41–122℉） 宽温适配
存储温度 (Storage Temp) -20–55℃ 长期存储安全
注册信息 (Registration) 二类医疗器械（以国内注册证为准） 符合医用安全标准
五、使用方法 (Instructions)
中文
设备准备：安装 EMMA? 气道适配器（成人 / 儿童 / 婴儿款），连接电池，开机自检Masimo。
回路连接：将 Radius PCG 串联于气管导管与呼吸球囊 / 呼吸机之间，确保气路密封。
患者准备：建立人工气道（气管插管 / 喉罩），确认气道通畅，连接呼吸回路。
参数设置：选择患者年龄组别，按需调整 EtCO? 报警上下限与显示单位（mmHg/kPa）Masimo。
启动监测：观察 EtCO? 波形与数值，确认导管位置正确；持续监测通气效果与循环状态。
数据管理：通过 Root? 平台查看趋势、导出数据或上传至电子；监测结束取下设备Masimo。
结束操作：关闭电源，拆卸适配器与传感器，按规范清洁与存放Masimo。
英文
Device Setup: Install EMMA? airway adapter (adult/pediatric/infant), insert batteries, and power on for self-testMasimo.
Circuit Connection: Inline Radius PCG between endotracheal tube and breathing bag/ventilator; ensure airtight seal.
Patient Prep: Establish artificial airway (ETT/LMA), confirm patency, and connect to the breathing circuit.
Parameter Settings: Select age group; adjust EtCO? alarm limits and display unit (mmHg/kPa) as neededMasimo.
Start Monitoring: Observe EtCO? waveｆorm and values to confirm correct tube placement; continuously assess ventilation and circulation.
Data Management: Review trends, export data, or upload to EHR via Root?; remove device after monitoringMasimo.
Completion: Power off, disconnect adapters/sensors, clean and store per guidelinesMasimo.
六、适应症 (Indications)
中文
气道管理：气管插管 / 喉罩位置确认，尤其是心肺复苏期间快速判断导管是否误入食道。
术中监测：手术室、麻醉复苏室（PACU）全麻患者通气与二氧化碳潴留评估。
重症监护：ICU 患者呼吸衰竭、机械通气、休克等场景的通气与循环功能监测。
急诊与院前：急救现场、转运途中的实时 EtCO? 监测，指导复苏与通气策略。
新生儿 / 儿科：早产儿、新生儿窒息、儿科手术的低死腔监测。
长期护理：长期机械通气患者的居家 / 机构监护，保障通气安全。
英文
Airway Management: Confirmation of ETT/LMA placement, especially during CPR to rule out esophageal intubation.
Intraoperative Monitoring: Ventilation and hypercapnia assessment for anesthetized patients in OR/PACU.
Critical Care: Ventilation and circulation monitoring for ICU patients with respiratory failure, mechanical ventilation, or shock.
Emergency & Pre-hospital: Real-time EtCO? monitoring in EMS and patient transport to guide resuscitation and ventilation.
Neonatal/Pediatric: Low-dead-space precision monitoring for preterm infants, asphyxia, and pediatric surgeries.
Long-term Care: Home/institutional monitoring of mechanically ventilated patients to ensure ventilation safety.
七、禁忌症 (Contraindications)
中文
绝对禁忌：对设备材料或适配器粘合剂过敏者禁用。
气道禁忌：严重气道出血、大量分泌物阻塞、开放性气胸 / 支气管胸膜瘘（易致 CO? 泄漏，测量误差大）。
设备禁忌：呼吸回路严重漏气无法密封者禁用；一次性适配器严禁重复使用或消毒复用。
特殊场景：强电磁干扰环境（如 MRI 室）需暂停使用，避免信号异常。
英文
Absolute Contraindication: Contraindicated in patients allergic to device materials or adapter adhesive.
Airway Contraindications: Severe airway bleeding, massive secretions obstruction, open pneumothorax/bronchopleural fistula (risk of CO? leakage and measurement error).
Device Contraindications: Severe breathing circuit leak uncorrectable; disposable adapters must not be reused or re-sterilized.
Special Settings: Suspend use in strong EMF environments (e.g., MRI room) to avoid signal anomalies。
八、注意事项 (Precautions)
中文
专业操作：经培训医护人员使用，EtCO? 结果需结合临床体征综合判断，不可单独作为决策依据。
气道维护：每 4–8 小时检查适配器与气路，及时清除分泌物，防止堵塞或漏气；新生儿 / 儿童延长监测时加强皮肤与气道保护。
设备维护：禁止拆解、浸泡或高压灭菌；仅用软布清洁表面，避免液体进入主机。
电池管理：长期闲置每 3 个月充电一次，防止过放电；使用原装电池确保安全与续航。
报警处理：及时响应报警，排查无呼吸、适配器堵塞等原因，确保监测连续可靠。
数据安全：蓝牙传输需加密，防止数据泄露；导出数据遵守医院隐私法规。
临床判断：EtCO? 与 PaCO? 可能存在差异，需结合动脉血气结果调整通气策略。
英文
Professional Use: For trained clinicians only; combine EtCO? results with clinical signs for decision-making.
Airway Maintenance: Check adapter/circuit every 4–8 hours; clear secretions promptly to prevent clogging/leaks. Enhance skin/airway care for prolonged monitoring in neonates/children.
Device Care: Do not disassemble, submerge, or autoclave; clean surface only with a soft cloth to avoid liquid ingress.
Battery Care: Charge every 3 months during long storage to prevent over-discharge; use original batteries for safety/runtime.
Alarm Response: Address alerts promptly (apnea, clogged adapter) to ensure continuous reliable monitoring.
Data Security: Encrypt Bluetooth transmission to prevent leaks; comply with hospital privacy regulations for data export.
Clinical Judgment: EtCO? may differ from PaCO?; adjust ventilation with arterial blood gas results。
九、存储条件 (Storage Conditions)
中文
主机 / 电池：温度 -20℃～+55℃，湿度 10%～95% RH（无冷凝），干燥、防尘、避强光与腐蚀性气体。
未开封适配器：温度 5℃～30℃，湿度 30%～70% RH，密封避光、防潮，禁止冷冻或高温暴晒。
运输：防震、防潮、防碰撞，使用原包装，避免极端温度 / 湿度环境，确保设备完好。
英文
Main Unit/Battery: -20℃ to +55℃, 10%–95%RH (non-condensing); store in a dry, dust-free, low-light, and non-corrosive gas environment.
Unopened Adapters: 5℃ to 30℃, 30%–70%RH; sealed, dark, moisture-proof; no freezing or high-temperature exposure.
Transport: Shockproof, moistureproof, anti-collision; ship in original packaging to avoid extreme temperature/humidity。
十、说明书核心信息 (Manual Core Info)
中文
产品组成：Radius PCG 主机、EMMA? 成人 / 儿童 / 婴儿气道适配器、电池、收纳袋、挂绳、说明书Masimo。
注册信息：二类医疗器械（国内注册证号以官方发布为准），符合 IEC 60601-1-2 电磁兼容标准。
适用人群：成人、儿童、婴儿，需配合 EMMA? 专用适配器使用Masimo。
质保与寿命：主机 1 年有限保修，适配器为一次性无质保，设计寿命 5 年。
安全分类：BF 型应用部分，防除颤干扰，连续运行设备。
废弃处置：按医疗废弃物与电子垃圾法规分类处理，避免环境污染。
关键提示：无适配器或适配器堵塞时无有效读数，需及时更换Masimo。
英文
Components: Radius PCG main unit, EMMA? adult/pediatric/infant airway adapters, batteries, pouch, lanyard, and manualMasimo.
Registration: Class II medical device (official registration number to be confirmed); compliant with IEC 60601-1-2 EMC standards.
Target Population: Adults, children, and infants; use with EMMA? dedicated adaptersMasimo.
Warranty/Lifespan: 1-year limited warranty for main unit; no warranty for disposable adapters; 5-year design life.
Safety Classification: Type BF applied part, defibrillation-proof, continuous operation device.
Disposal: Classify and dispose per medical waste/e-waste regulations to avoid environmental pollution.
Key Note: No valid reading without an adapter or with a clogged adapter; replace promptlyMasimo
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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