厂商直供德恩欧美达通用熊猫婴儿辐射保暖台Panda
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厂商直供德恩欧美达通用熊猫婴儿辐射保暖台Panda
桂经理19117326863微xin同号
结构及组成/主要组成成分
保暖台由一个支架组件、机动化升降底座(在手动可调节底座选件上不存在)、婴儿床组件、床上内置体重秤(可选)、探头面板组件、Nellcor SpO2模块(可选)、Masimo SpO2模块(可选)、导轨结构、气囊和面罩复苏模块（可选）、T型管复苏模块（可选）和加热器头部组件。附件列表见附页。
适用范围/预期用途
婴儿辐射保暖台用于为婴儿和儿科病人提供控制的辐射热源。它可用于帮助新生儿过渡到外部环境，或为婴儿创造一个受控制的开放环境。可选的集成式SpO2监测功能可用于对脉搏血氧饱和度（SpO2）和脉率（由SpO2传感器测量）进行持续的监测。可选的集成式复苏系统可用于为婴儿肺复苏提供必需的基本设备。肺复苏包括保持气道通畅、提供氧气或空气/氧气的混合气体，及/或对婴儿进行手持通气。
一、工作原理 (Working Principle)
中文
Panda 婴儿辐射保暖台采用红外辐射加热技术与微电脑伺服闭环控温系统。设备通过嵌入式红外热源发射远红外线，以辐射传热方式直接作用于婴儿体表，快速提升并维持体温；腹部肤温传感器实时采集婴儿皮肤温度，反馈至控制系统，与设定温度对比后动态调节红外加热功率，实现恒温。配备独特 ** 沙漏热分布（Hourglass Heat Profile）** 技术，确保床面热量均匀柔和，同时降低医护人员操作区域温度。
英文
Panda Infant Radiant Warmer adopts infrared radiation heating technology and microcomputer servo closed-loop temperature control system. The ｅmbedded infrared heat source emits far-infrared rays, directly heating the infant's body via radiation to rapidly stabilize temperature. An abdominal skin temperature sensor collects real-time skin temperature, which is fed back to the control system. The system dynamically adjusts heating power by comparing actual and set temperatures for precise thermoregulation. The exclusive Hourglass Heat Profile ensures uniｆorm, gentle heat distribution over the bed while keeping the caregiver area cool.
二、功能 (Functions)
中文
控温：预热、手动、肤温伺服 3 种模式，肤温范围 32℃～37.5℃，控温精度≤±0.5℃。
实时监测：全彩屏显示皮肤温度、设定温度、加热功率，可选配 SpO?、心率、呼吸监测。
智能报警：超温、低温、传感器脱落、断电、系统故障声光报警，支持免提报警静音。
复苏支持：集成 APGAR 计时、ResusView 心电图界面，适配产房新生儿窒息复苏。
临床辅助：内置电子秤（精度 ±5g）、X 光暗盒托盘、床体倾斜调节（-15°～+15°）、可调光观察灯。
数据管理：存储温度、生命体征趋势，支持数据导出与电子对接。
安全防护：独立双回路超温保护、防跌落挡板、抗菌床面、防辐射泄漏设计。
英文
Precise Temperature Control: 3 modes (preheat, manual, servo); skin temp range 32–37.5℃, accuracy ≤±0.5℃.
Real-time Monitoring: Full-color display of skin/set temperature, heating power; optional SpO?, HR, respiration monitoring.
Smart Alarms: Audible/visual alerts for over/under temp, sensor disconnect, power failure; hands-free alarm silencing.
Resuscitation Support: Integrated APGAR timer, ResusView ECG interface for delivery room resuscitation.
Clinical Aids: Built-in scale (±5g), X-ray cassette tray, bed tilt (-15°~+15°), dimmable exam lights.
Data Management: Stores temperature/vital sign trends; supports data export and EHR integration.
Safety Features: Dual over-temperature protection, anti-fall guards, antimicrobial bed, anti-leak design.
三、产品特点 (Product Features)
中文
均匀热分布：沙漏热 profile 技术，床面温差≤2℃，避免局部过热，婴儿体感舒适。
免提操作：红外感应免提报警静音，解放医护双手，提升复苏操作效率。
集成化设计：一体化监护、称重、X 光、复苏功能，减少设备占用，便于抢救操作。
低噪舒适：静音运行，柔和光线，可调床角，降低新生儿应激反应。
灵活辐射头：辐射头 360° 旋转，可升降，适配不同体位与操作需求。
抗菌易洁：床体采用抗菌医疗级材质，可拆卸挡板，便于消毒，降低感染风险。
安全可靠：双独立超温保护、传感器故障报警、防漏电设计，符合 IEC 60601 标准。
英文
Uniｆorm Heat: Hourglass Heat Profile ensures bed temp variance ≤2℃, preventing hot spots and maximizing comfort.
Hands-Free: Infrared hands-free alarm silencing for uninterrupted resuscitation care.
Integrated Design: All-in-one monitoring, weighing, X-ray, and resuscitation tools save space.
Low-Stress: Quiet operation, soft lighting, adjustable bed tilt reduce infant stress.
Flexible Header: 360° rotating, height-adjustable heater for optimal access.
Antimicrobial: Medical-grade antimicrobial surfaces, removable guards for easy disinfection.
Safe & Reliable: Dual over-temperature protection, sensor fail alarms, IEC 60601 compliant.
四、技术参数 (Technical Specifications)
表格
参数项 (Parameter) 规格 (Specification) 中文说明 (Chinese Note)
控温模式 (Control Modes) 预热 / 手动 / 肤温伺服 (Preheat/Manual/Servo) 三种温控模式适配临床需求
温度范围 (Temp Range) 肤温：32℃～37.5℃；手动：0～100% 功率 覆盖新生儿正常体温区间
控温精度 (Temp Accuracy) ≤±0.5℃ 高精度恒温控制
床面均匀性 (Bed Uniｆormity) ≤2℃ 热量分布均匀
称重范围 (Weighing) 0～10kg，精度 ±5g 内置电子秤
床体调节 (Bed Tilt) -15°～+15° 头高脚低 / 头低脚高调节
辐射头 (Radiant Heater) 360° 旋转，高度可调 灵活操作空间
显示 (Display) 7 英寸全彩触摸屏 清晰直观
电源 (Power) AC 100～240V，50/60Hz 宽电压适配
安全分类 (Safety) BF 型，防除颤，连续运行 医用安全标准
注册证 (Registration) 国械注进 20153080985 进口三类医疗器械
五、使用方法 (Instructions for Use)
中文
设备准备
锁定脚轮，连接电源，开机自检，确认无故障报警。
安装肤温传感器，贴于婴儿腹部（剑突与脐连线中点），胶布固定确保紧贴皮肤。
选择预热模式，待床温达 36℃后放入婴儿。
模式选择
常规护理：肤温伺服模式，设定 36.5℃～37℃，自动控温。
复苏 / 手术：手动模式，固定加热功率（50%～80%），快速复温。
术前准备：预热模式，床面预温，减少婴儿体温波动。
临床操作
调节床体角度，安装 X 光托盘 / 输液架，连接监护模块。
开启观察灯，设置报警限，启动实时监测与数据记录。
每 30 分钟核查温度、传感器位置、皮肤状况。
结束使用
关闭加热，移除传感器，清洁床面与挡板。
关机断电，设备归位，记录使用数据。
英文
Device Setup
Lock casters, connect power, perｆorm self-test; confirm no alarms.
Apply skin sensor to infant’s abdomen (mid-xiphoid-umbilicus); secure with tape.
Select preheat mode; place infant when bed reaches 36℃.
Mode Selection
Routine care: Servo mode (36.5–37℃) for automatic control.
Resuscitation/surgery: Manual mode (50–80% power) for rapid rewarming.
Pre-op prep: Preheat mode to stabilize bed temperature.
Clinical Operation
Adjust bed tilt; mount X-ray tray/IV pole; connect monitors.
Activate lights, set alarms, start trend recording.
Verify temp, sensor placement, skin condition q30min.
Completion
Turn off heater, remove sensor, clean bed/guards.
Power down, secure unit, log usage data.
六、适应症 (Indications)
中文
产房新生儿：出生后立即保暖，预防低体温，支持窒息复苏。
早产儿 / 低体重儿：胎龄＜37 周、体重＜2500g，维持体温稳定。
危重症监护：呼吸窘迫、休克、术后、感染等开放气道护理。
新生儿复苏：APGAR 评估、气管插管、胸外按压等操作时恒温保障。
诊疗操作：X 光拍片、穿刺、换药、蓝光治疗（选配）等场景。
转运过渡：院内短距离转运、检查前后体温维持。
英文
Delivery Room: Immediate warmth for newborns; hypothermia prevention; resuscitation support.
Preterm/LBW Infants: Gestation <37 weeks, weight <2500g; temperature stabilization.
Critical Care: Open-airway care for RDS, shock, post-op, infection.
Resuscitation: Constant warmth during APGAR, intubation, CPR.
Procedures: X-ray, aspiration, dressing changes, phototherapy (optional).
Transfer: Short-distance transport; pre/post-procedure temp maintenance.
七、禁忌症 (Contraindications)
中文
绝对禁忌：严重皮肤破损、感染、烧伤（传感器无法安全贴附）。
相对禁忌：
超早产儿（＜28 周）：需暖箱减少不显性失水。
高热患儿（核心温＞38.5℃）：禁用加热模式。
皮肤过敏：对传感器粘合剂过敏者。
开放性气胸 / 严重呼吸衰竭：需密闭通气支持。
英文
Absolute: Severe skin lesions, infection, burns (sensor cannot safely adhere).
Relative:
Extreme preterm (<28 weeks): Use incubator to reduce insensible water loss.
Hyperthermia (core >38.5℃): Heating mode prohibited.
Sensor adhesive allergy.
Open pneumothorax/severe RF: Requires closed ventilation.
八、注意事项 (Precautions)
中文
专业操作：经培训医护使用，严禁无人值守。
传感器管理：确保紧贴皮肤，每 2 小时检查，防止脱落致过热。
温度监测：伺服模式为主，手动模式需每 15 分钟测体温。
皮肤护理：每 4 小时查看皮肤，避免烫伤 / 压红；长期使用加湿防脱水。
安全防护：床栏全程升起，锁脚轮，防跌落 / 移动。
干扰规避：远离 MRI、高频电刀，防电磁干扰。
设备维护：禁止拆解、浸泡；用软布 / 中性消毒剂清洁。
电池备用：选配 UPS，断电时维持加热与报警。
英文
Professional Use: Trained staff only; no unattended operation.
Sensor Care: Ensure tight adhesion; check q2h to prevent overheating.
Temp Monitoring: Prefer servo mode; manual mode requires q15min temp checks.
Skin Care: Inspect q4h for burns/redness; humidify long-term use to prevent dehydration.
Safety: Keep guards up, lock casters to prevent falls/movement.
Interference: Keep away from MRI, electrosurgical units.
Maintenance: No disassembly/submersion; clean with soft cloth/neutral disinfectant.
Backup: Optional UPS maintains heat/alarms during power failure.
九、存储条件 (Storage Conditions)
中文
主机：温度 - 20℃～+55℃，湿度 10%～95% RH（无冷凝），干燥通风、防尘避腐蚀气体。
传感器 / 附件：温度 5℃～30℃，湿度 30%～70% RH，密封避光、防潮，禁冷冻 / 暴晒。
运输：防震、防潮、防碰撞，原包装运输，避免极端温湿度。
长期存储：每月通电自检 30 分钟，保持电子元件活性。
英文
Main Unit: -20℃ to +55℃, 10–95%RH (non-condensing); dry, dust-free, corrosion-free.
Sensors/Accessories: 5–30℃, 30–70%RH; sealed, dark, moisture-proof; no freezing/exposure.
Transport: Shock/moisture/collision proof; ship in original packaging.
Long-Term: Power on self-test q30 days monthly to maintain electronics.
十、说明书核心信息 (Manual Core Inｆormation)
中文
组成：主机、红外辐射头、肤温传感器、床体、抗菌床垫、可拆卸挡板、X 光托盘、内置秤、电源线。
注册：国械注进 20153080985，三类医疗器械，符合 IEC 60601-1/-2。
适用人群：新生儿、早产儿、低体重儿、病危儿（0～28 天）。
质保：主机 1 年有限保修，传感器 / 耗材无质保，设计寿命 5 年。
安全：BF 型应用部分，双回路超温保护，防除颤，连续运行。
废弃：按医疗 / 电子废弃物法规分类处理，环保回收。
关键提示：传感器脱落自动切换手动模式并报警；严禁覆盖辐射头。
英文
Components: Main unit, infrared heater, skin sensor, bed, antimicrobial mattress, guards, X-ray tray, built-in scale, power cord.
Registration: NMPA 20153080985, Class III, IEC 60601-1/-2 compliant.
Population: Newborns, preterms, LBW, critically ill (0–28 days).
Warranty: 1-year main unit; no warranty for sensors; 5-year design life.
Safety: Type BF, dual over-temp protection, defibrillator-proof, continuous operation.
Disposal: Recycle per medical/e-waste regulations.
Key Note: Sensor disconnect switches to manual with alarm; never block heater.
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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