厂商直销美国GE通用婴儿保暖台Lullaby
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厂商直销美国GE通用婴儿保暖台Lullaby
桂经理19117326863微xin同号
桂经理19117326863微xin同号
管理类别
第三类
型号规格
Lullaby
结构及组成/主要组成成分
本产品由主机(包括加热器组件、控制面板、床垫系统、观察灯、燕尾导轨系统、报警系统、APGAR计
时器)、X射线盘、肤温探头、储物抽屉、床下储物盘、电线杆、输液杆、监护仪/仪器托盘、气瓶固定器、篮筐组件、管路管理臂、
复苏袋夹、引流管吊架和软管固定夹组成。
适用范围/预期用途
该产品可以通过一种可控的方式为无法通过自身生理机能保持体温调节的婴儿提供红外线辐射热源,
可用于帮助新生儿顺利转移至外部环境或提供一个可控的开放微环境。
1、工作原理 Working Principle
中文:设备采用 Calrod® 红外辐射加热组件,配合抛物面反射器将红外热辐射均匀投射至婴儿床面;微处理器接收肤温探头采集的婴儿皮肤温度信号,分为伺服(婴儿模式)、手动模式两种控温逻辑。婴儿模式下根据实测肤温与设定温度差值自动调节加热输出功率;手动模式由操作人员直接设定加热功率百分比。设备建立可控开放式红外辐射微环境,补偿新生儿散热,预防低体温,床体支持倾斜、快速床旁操作,配套报警系统监控温度、探头、加热器、电源异常GE HealthC...。
English:The device adopts Calrod® infrared‑radiation heating assembly, with parabolic reflector distributing infrared thermal radiation evenly onto the bed surface. The micro‑processor receives skin‑temperature signals from the skin‑temperature probe. Two control logics are available: Servo (Baby Mode) and Manual Mode. In Baby Mode, heater output power is automatically adjusted according to the deviation between measured skin temperature and set‑point temperature. In Manual Mode, heating power percentage is manually set by operator. It creates a controllable open micro‑environment with infrared radiation to compensate heat loss and prevent neonatal hypothermia. The bed supports tilting and rapid bedside intervention, integrated alarm system monitors abnormalities of temperature, probe, heater and power supply。
2、产品功能 Product Functions
表格
| 中文 | English |
|---|---|
| 1. 婴儿伺服控温模式(Baby Mode),基于肤温闭环自动控温 | 1.Baby Servo Mode: closed‑loop automatic temperature control based on infant skin temperature |
| 2. 手动功率调节模式,加热功率以 5% 步进可调 | 2.Manual Mode, heating power adjustable in 5% increments |
| 3.APGAR 新生儿评分计时器 | 3.APGAR score timer |
| 4. 床面观察检查灯 | 4.Bed‑surface examination observation light |
| 5. 床体 ±15° 倾斜,支持特伦德伦堡 / 反特伦德伦堡体位 | 5.Bed tilting ±15°, Trendelenburg / Reverse‑Trendelenburg positioning |
| 6. 全套声光报警:婴儿状态报警、探头故障、加热器故障、电源失效、超温 / 低温报警 | 6.Acoustic‑visual alarm suite: Check‑baby alarm, probe failure, heater failure, power‑failure, over‑temperature / under‑temperature alarm |
| 7. 兼容床位 X 射线拍片托盘,无需搬动患儿 | 7.Integrated X‑ray cassette tray for bedside radiography without moving infant |
| 8. 配套输液杆、储物抽屉、气瓶固定、管路管理组件 | 8.Accessories: IV pole, storage drawer, gas cylinder holder, tubing management assembly |
3、产品特点 Product Features
中文
Calrod® 加热源,升温速度快,床面热量分布均匀,“Walls of Warmth” 热墙技术减少侧向热流失GE HealthC...。
双工作模式,伺服模式自动控温,手动模式适配复苏急救场景。
彩色编码报警提示,远距离可视全局报警;大尺寸数字显示屏同时显示实测温度、设定温度。
床侧翻折护栏,急救时可快速无阻碍接近新生儿。
床面可快速预加热,分娩前可提前建立预热就绪状态。
整机表面易擦拭消毒,便于感染控制。
模块化附件,产房、NICU、复苏室多场景兼容;整机移动脚轮,转运便捷GE HealthC...。
English
Calrod® heating element, fast warm‑up and uniform heat distribution; “Walls of Warmth” technology to reduce lateral heat lossGE HealthC....
Dual‑mode operation: servo automatic control for routine care, manual mode optimized for resuscitation.
Color‑coded alarm indicators, long‑range visual global alarm; large digital display showing measured & set temperature simultaneously.
Fold‑down side rails for unobstructed rapid access during emergency resuscitation.
Fast pre‑warming function, ready‑state preheat prior to delivery.
Smooth surface for easy wiping & disinfection for infection control.
Modular accessories, compatible for L&D, NICU and resuscitation room; mobile casters for easy transportationGE HealthC....

4、技术参数 Technical Specifications
表格
| 项目 Item | 中文参数 | English Specification |
|---|---|---|
| 供电 Power Supply | 220VAC±10%,50/60Hz | 220VAC±10%, 50/60Hz |
| 最大功耗 Max Power Consumption | 380W | 380W |
| 控温范围(伺服模式)Temperature Range (Servo) | 30.0℃‑42.0℃ | 30.0℃‑42.0℃ |
| 手动功率调节 Manual Power Adjustment | 0‑100%,5% 步进 | 0‑100%, 5% step increment |
| 观察灯功率 Observation Lamp | 50W | 50W |
| 床体倾斜 Bed Tilt | ±15° | ±15° |
| 床垫尺寸 Mattress Dimension | 640 × 462 × 25.4 mm | 640 × 462 × 25.4 mm |
| 最大患儿承重 Max Patient Load | 20 kg | 20 kg |
| 安全标准 Safety Standard | IEC 60601‑1;IEC 60601‑2‑21 | IEC 60601‑1;IEC 60601‑2‑21 |
| 加热头预加热逻辑 Pre‑heat Logic | 初始 100% 功率运行 12 分钟后降至 25% 待机输出 | 100% power for 12 min, then drop to 25% standby outputGE HealthC... |

5、使用方法 Operation Procedure
中文
设备就位,接通电源,开机自检,确认无故障报警。需要时提前执行床面预加热。
根据临床场景选择模式:
婴儿(伺服)模式:将肤温探头可靠粘贴于新生儿腹部皮肤,避免探头受压、被敷料覆盖;设置目标皮肤温度,设备自动调节加热输出,持续闭环控温。
手动模式:关闭伺服控制,直接设置加热功率百分比;手动模式必须定时人工测量新生儿体温。
根据诊疗需求调节床体倾斜角度,开启观察灯用于查体;启动 APGAR 计时器用于新生儿出生评分。
运行期间关注全部报警信息,及时处置探头脱落、超温、加热器故障等告警。
可使用 X 射线托盘完成床旁拍片;使用输液杆、管路组件固定各类管路。
使用结束,关闭加热与整机电源,执行清洁与消毒流程。
注意:伺服模式禁止用于发热、休克患儿;保暖台内新生儿建议裸露,覆盖被褥会阻断红外辐射加热效果。
English
Position unit, connect mains power, power‑on self‑test and confirm no fault alarms. Perform pre‑warming if required before patient arrival.
Select operation mode according to clinical scenario:
Baby (Servo) Mode: Attach skin‑temperature probe firmly onto infant abdominal skin; avoid probe compression or dressing coverage. Set target skin temperature, unit automatically adjusts heater output for closed‑loop thermal regulation.
Manual Mode: Disable servo control, manually set heating power percentage. Periodic manual body‑temperature measurement is mandatory under Manual Mode.
Adjust bed tilt as clinical requirement; turn on observation lamp for examination; activate APGAR timer for birth scoring.
Monitor all alarms continuously; promptly respond to probe disconnection, over‑temperature, heater failure and other alerts.
Utilize X‑ray cassette tray for bedside radiography; secure tubing via IV pole and tubing accessories.
Upon completion: turn off heater and main power, perform cleaning and disinfection.
Note: Servo Mode is contraindicated for febrile or shocked infants. Infant shall remain uncovered; blankets will block infrared radiant heating effect.
6、适应症 Indications for Use
中文:用于无法依靠自身生理机能维持体温调节的新生儿、早产儿,提供可控红外辐射开放式微环境;用于产房新生儿复苏、转运过渡、NICU 高危新生儿保温护理,预防新生儿低体温,维持稳定皮肤温度。
English: Intended for neonates and preterm infants who cannot maintain body temperature by physiological self‑regulation. Provides controllable open‑field infrared‑radiant micro‑environment. Applied for delivery‑room neonatal resuscitation, thermal stabilization during transition, thermal care for high‑risk infants in NICU, to prevent neonatal hypothermia and maintain stable skin temperatureFDA Access...。

7、禁忌症 Contraindications
中文
婴儿模式(伺服控温)禁止用于发热、休克状态新生儿。
不适合作为密闭孵育设备,不可替代新生儿暖箱;不能用于需要密闭高湿度环境的治疗场景。
体表严重烧伤、大面积皮肤缺损,无法可靠粘贴肤温探头的患儿,禁止使用伺服模式。
不可用于需要隔绝红外辐射热源的特殊诊疗场景。
English
Baby Servo Mode shall NOT be used for febrile or shocked neonates.
Not designed as closed incubator; cannot replace neonatal incubator; not suitable for therapy requiring closed high‑humidity environment.
Servo Mode is contraindicated for patients with severe cutaneous burn or extensive skin defect where reliable probe attachment cannot be achieved.
Not for special clinical scenarios requiring full isolation from infrared radiant heat source.
8、注意事项 Warnings & Cautions
中文
仅可由经培训医护人员操作本设备。
肤温探头严禁被敷料、衣物覆盖,会造成测温失真,引发过热风险。
手动模式无自动闭环控温,必须定时实测新生儿体温。
伺服模式下如患儿发热 / 休克,必须切换手动模式或停止辐射加热。
不要在加热头正上方堆放物品;避免液体泼洒至加热组件与控制面板。
报警静音仅可短时使用,不可长期关闭报警功能。
床侧护栏翻折开启状态,看护人员不得离开患儿。
设备接地必须可靠;禁止使用非原厂探头、非原厂配件。
定期执行设备预防性维护,按说明书周期更换探头、加热组件。
设备为开放式辐射热源,注意监测患儿不显性失水情况。
English
Device shall only be operated by trained clinical staff.
Skin‑temperature probe must not be covered by dressing or clothing, which causes false temperature reading and hyperthermia hazard.
Manual Mode has no closed‑loop thermal control; periodic manual infant temperature measurement is mandatory.
If patient becomes febrile or shocked under Servo Mode, switch to Manual Mode or discontinue radiant heating.
Do not place objects above heater hood; prevent liquid spillage onto heater assembly and control panel.
Alarm silence is for short‑term use only; long‑term alarm suppression is prohibited.
Never leave infant unattended when side rails are folded down.
Reliable protective earth connection required; only original manufacturer‑approved probes and accessories can be used.
Perform scheduled preventive maintenance; replace probe and heater component following IFU replacement cycle.
As open radiant heat source, monitor infant insensible water loss closely.
9、存储条件 Storage Condition
中文:环境温度:‑10℃~+55℃;相对湿度:10%‑90%(无凝露);大气压力:500hPa‑1060hPa;存放于干燥通风室内,避免阳光直射、粉尘、腐蚀性气体;整机断电状态存储,移动时做好防护,防止剧烈撞击。
English: Ambient temperature:‑10℃~+55℃; Relative humidity:10%‑90% (non‑condensing); Atmospheric pressure:500hPa‑1060hPa. Store in dry, ventilated indoor space; avoid direct sunlight, dust and corrosive gas. Store under power‑off condition, protect unit against heavy impact during transportation.

10、说明书核心摘要 IFU Core Summary
中文GE Lullaby 婴儿辐射保暖台是 Ⅲ 类医用设备,依靠红外辐射对新生儿开放环境保温;拥有婴儿伺服模式、手动模式两套控温逻辑,集成 APGAR 计时器、观察灯、床倾斜、床旁拍片托盘与完整报警链。伺服模式依靠皮肤探头闭环控温,严禁发热、休克患儿使用伺服模式;手动模式必须定时测体温;探头禁止被覆盖;新生儿建议裸露以保障辐射加热效率;由培训合格医护操作,使用原厂配件,定期维护;不可替代密闭婴儿暖箱。存储需干燥无凝露环境。所有报警不得长期静音。
English Core SummaryGE Lullaby Infant Radiant Warmer is Class Ⅲ medical device providing open‑field thermal support via infrared radiation. Two control modes are available: Baby Servo Mode and Manual Mode. Integrated APGAR timer, examination lamp, bed tilting, bedside X‑ray tray and full alarm chain. Servo Mode uses skin probe for closed‑loop regulation, contraindicated for febrile or shocked infants. Periodic manual temperature measurement is mandatory under Manual Mode. Probe shall never be covered. Infant should be uncovered to guarantee radiant heating efficiency. Operated only by qualified trained clinical personnel, use OEM‑approved accessories and perform scheduled maintenance. It cannot substitute closed neonatal incubator. Store in dry non‑condensing environment. Long‑term alarm silencing is prohibited.
以上产品详情仅供参考,临床操作请以原厂纸质说明书为准。上海康世达医疗器械有限公司不生产医疗产品,所有产品均来自产品的生产厂家,代理商,经销商,如有侵权请联系我们,会尽快处理!The above product details are for reference only. All clinical operations shall be carried out in strict accordance with the original paper instructions for use issued by the manufacturer.
Shanghai Kangshida Medical Devices Co., Ltd. does not manufacture medical devices. All products are sourced from respective manufacturers, authorized agents and distributors.
Please contact us promptly in case of any infringement, and we will resolve the matter as soon as possible.
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