厂商直供戴维婴儿培养箱YP-600,YP-100
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厂商直供戴维婴儿培养箱YP-600,YP-100
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
YP-100A、YP-100AB、YP-600、YP-600A、YP-600B、YP-600C、YP-600D
结构及组成/主要组成成分
由主机（包括婴儿舱、机箱、控制仪、输液架及托盘）、机座、上黄疸治疗装置（YP-100A 无）、下黄疸治疗装置（YP-100A、YP-100AB无）、皮肤温度传感器（YP-100A、YP-100AB可选件）、脉搏血氧监测装置（YP-100A、YP-100AB无，含有传感器延长线但不含血氧传感器）和称重装置（选配，YP-100A、YP-100AB无）组成。
适用范围/预期用途
YP-100A婴儿培养箱用于早产儿或病弱儿的培养成长；YP-100AB婴儿培养箱用于早产儿或病弱儿的培养成长，以及新生儿高胆红素血症的光照治疗；YP-600、YP-600A、YP-600B、YP-600C、YP-600D婴儿培养箱用于早产儿或病弱儿的培养成长，新生儿高胆红素血症的光照治疗，以及动脉血氧饱和度（SpO2）和脉搏率（PR）的连续测量。
一、工作原理 Principle of Operation
中文设备通过微处理器 PID 闭环控制系统，对经过过滤的空气进行加热、加湿处理；加热加湿后的洁净空气在婴儿舱内循环流动，构建中性热环境。箱内空气传感器、皮肤温度传感器采集实时温度信号反馈至主控单元，自动调节加热输出功率，维持舱内温湿度稳定。 YP‑600 内置蓝光光疗模块，通过 LED 蓝光照射分解血液胆红素；集成血氧模块采集脉搏血氧饱和度；选配称重模块实现婴儿体重测量。整机多重独立安全回路与报警系统，实现超温、故障、断电保护，模拟母体宫内环境，用于新生儿保育治疗。
EnglishAdopts micro‑processor PID closed‑loop control system to heat and humidify filtered air. Treated clean air circulates inside the infant chamber to establish a neutral thermal environment. Air temperature sensor and skin temperature sensor feed real‑time temperature data back to main control unit to automatically adjust heating power and stabilize chamber temperature & humidity. YP‑600 is equipped with built‑in LED blue‑light phototherapy module to decompose serum bilirubin; integrated non‑invasive SpO₂ monitoring module for pulse oxygen saturation measurement; optional weighing module for infant weight detection. Multiple independent safety circuits and alarm systems provide over‑temperature, fault and power‑failure protection to simulate intrauterine environment for neonatal care and treatment。
二、主要功能 Main Functions
中文
温度控制：箱温模式、皮肤伺服控温模式；
湿度调节：风道式加湿，湿度可调；
光疗治疗（YP‑600 标配；YP‑100B/AB 版本）：双面蓝光黄疸治疗，PWM 无级调节蓝光辐照度，计时功能；
生命体征监测（YP‑600）：脉搏血氧饱和度 SpO₂、脉搏 PR 连续监测；
婴儿称重（YP‑600 选配）；
7 寸彩色触控显示屏（YP‑600）；YP‑100 数码分屏显示；
声光报警、故障自检、数据存储；
RS‑232 数据通讯接口；婴儿床倾角无级调节；多组操作窗口便于临床护理；
独立超温保护、断电保护系统。
English
Temperature control: Air mode & skin‑servo control mode;
Humidity adjustment: Air‑duct humidification with adjustable humidity;
Phototherapy (Standard for YP‑600; YP‑100B/AB): Dual‑sided blue‑light jaundice therapy, PWM stepless adjustable irradiance, timer function;
Vital‑sign monitoring (YP‑600 only): Non‑invasive continuous monitoring of SpO₂ and pulse rate (PR);
Infant weighing (YP‑600 optional);
7‑inch color touch screen (YP‑600); split digital display for YP‑100;
Audible‑visual alarm, self‑diagnosis, data storage;
RS‑232 data communication interface; infinitely adjustable crib tilt angle; multiple access portholes for clinical nursing;
Independent over‑temperature protection and power‑failure protection system。
三、产品特点 Product Features
中文
PID 智能温控算法，箱内温度均匀、波动小；
低噪音无刷风机，营造安静保育环境；
透明婴儿舱，正门锁止机构，操作窗口减少环境扰动；
多重独立安全保护回路，故障声光报警；
YP‑600 双面嵌入式光疗，维护清洁便捷；支持 Masimo 血氧技术，低灌注下可靠测量；
移动脚轮，输液架、器械托盘、储物抽屉；
支持数据输出，便于病案记录；
符合 GB 9706.2‑19 婴儿培养箱国家安全标准宁波戴维医...。
English
Intelligent PID temperature‑control algorithm ensures even chamber temperature with minor fluctuation;
Low‑noise brushless fan provides quiet care environment;
Transparent infant hood with main‑door locking mechanism; access portholes minimize environmental disturbance;
Multiple independent safety protection circuits with audible‑visual fault alarms;
YP‑600 adopts ｅmbedded dual‑sided phototherapy for easy cleaning & maintenance; supports Masimo SpO₂ technology for reliable measurement under low perfusion;
Mobile casters, IV pole, instrument tray and storage drawers;
Data output supported for medical record documentation;
Complies with national safety standard GB 9706.2‑19 for infant incubators。
四、技术参数 Technical Specifications
表格
| 中文 | English |
|---|---|
| 电源：AC220V 50Hz，850VA | Power supply: AC220V 50Hz, 850VA |
| 箱温控制范围：25℃～37℃；跨越模式最高 39℃ | Air temp.range:25℃～37℃; override mode up to 39℃ |
| 肤温控制范围：34℃～37℃；跨越模式最高 38℃ | Skin temp.range:34℃～37℃; override mode up to 38℃ |
| 温度稳定性：稳定状态温差≤0.5℃ | Temperature stability: ≤0.5℃ under stable condition |
| 温度均匀性：床垫水平≤0.8℃；倾斜≤1.0℃ | Temperature uniｆormity: ≤0.8℃(horizontal crib); ≤1.0℃(tilted) |
| 舱内噪声：≤45dB (A) | Inner hood noise: ≤45dB(A) |
| 升温时间：≤40min | Heat‑up time: ≤40 min |
| 婴儿床：倾角无级可调 | Infant crib: infinitely adjustable tilt angle |
| 通讯接口：RS‑232 | Interface: RS‑232 |
| 光疗（YP‑600）：LED 双面蓝光，辐照度 PWM 可调 | Phototherapy(YP‑600): dual‑sided LED blue‑light, PWM adjustable irradiance |
| 血氧监测（YP‑600）：SpO₂：70‑100%；PR：30‑240bpm | SpO₂ monitoring(YP‑600): SpO₂:70‑100%; PR:30‑240bpm |
依据 GB/T 11243‑2020、产品注册技术要求整理中国食品药...。
五、使用方法 Operating Instructions
中文
安装检查：设备放置平整，锁定脚轮；检查电源线、水箱、过滤器、传感器、舱体密封完好；
开机自检：接通电源开机，设备自动自检，确认无报警故障；
参数设置：选择箱温模式 / 皮肤伺服模式，设置目标温度、湿度；开启 / 关闭光疗、血氧监测，设置光疗计时；
患儿安置：打开舱门，将新生儿置于婴儿床，关闭舱门并锁闭；通过操作窗口开展护理；按需调节床体倾斜角度；
运行监护：持续观察显示屏温度、报警信息；光疗时保护患儿眼睛；定期检查水位，及时补充蒸馏水；
结束使用：关闭光疗、监测模块；调低温度，关机；断电后开展设备清洁消毒；
选配称重功能：校准后执行婴儿体重测量。
English
Pre‑operation check: Place unit on level ground, lock casters. Verify power cord, water tank, filter, sensors and hood sealing in good condition.
Power‑on self‑test: Switch on power. Unit runs automatic self‑test; confirm no fault alarms.
Parameter setting: Select Air‑mode or Skin‑servo mode; set target temperature and humidity. Enable/disable phototherapy & SpO₂ monitoring; set phototherapy timer.
Patient placement: Open hood door; place neonate on crib; close and lock hood. Perｆorm nursing care via access portholes; adjust crib tilt as required.
Operation & surveillance: Continuously monitor display readings and alarms. Protect infant eyes during phototherapy. Check water level periodically and refill with distilled water.
Termination: Turn off phototherapy and monitoring modules; lower temperature then power off. Clean and disinfect after power cut‑off.
Optional weighing function: Perｆorm infant weight measurement after calibration.
六、适应症 Indications
中文
YP‑100 系列：用于早产儿、病弱新生儿的培育养护；带 B/AB 版本可用于新生儿高胆红素血症光疗治疗；
YP‑600 系列：早产儿、病弱新生儿培育养护；新生儿高胆红素血症蓝光光疗；对新生儿进行动脉血氧饱和度、脉搏率连续监测。
English
YP‑100 series: For care and cultivation of premature and sickly newborns. Model B/AB additionally for phototherapy of neonatal hyperbilirubinemia.
YP‑600 series: Care for premature and sickly newborns; blue‑light phototherapy for neonatal hyperbilirubinemia; non‑invasive continuous monitoring of arterial oxygen saturation (SpO₂) and pulse rate in neonates.
七、禁忌症 Contraindications
中文本设备无绝对禁忌症；
患儿存在需紧急外科处置的危重病情，不可仅依靠培养箱，应优先临床急救；
蓝光光疗禁忌症：直接诊断为梗阻性黄疸，禁止蓝光治疗；眼部损伤不适合蓝光照射；
不可用于成人、儿童以外年龄段患者。
EnglishNo absolute contraindications for the incubator itself.
For neonates with critical conditions requiring urgent surgical intervention, incubator shall not replace emergency clinical resuscitation.
Phototherapy contraindications: Obstructive jaundice is contraindicated for blue‑light therapy; patients with ocular injury shall not receive blue‑light irradiation.
Not intended for patients other than neonates / newborn infants.
八、注意事项 Warnings & Precautions
中文
仅可由经过培训的医护人员操作；
水箱只允许加注蒸馏水，严禁自来水；定期更换空气过滤器；
光疗使用中，必须为患儿佩戴护眼罩，保护视网膜；
禁止有机溶剂（酒精）擦拭有机玻璃舱罩，避免开裂雾化；
定期核对温度传感器精度，传感器线缆不可挤压弯折；
出现报警，优先排查故障，不可直接屏蔽报警；
设备运行中禁止打开机壳；维修维护由厂家授权工程师执行；
供氧使用时，注意舱内氧浓度监测，规避氧中毒风险；
移动设备务必先锁定脚轮再开展护理；
定期执行设备预防性维护，达到使用期限及时报废。
English
Shall only be operated by trained medical staff.
Only distilled water shall be filled into humidifier tank; tap‑water prohibited. Replace air filter periodically.
Eye‑shield must be worn for infant under phototherapy to protect retina.
Do not clean acrylic hood with organic solvents such as alcohol, to prevent cracking or hazing.
Calibrate temperature sensors regularly. Avoid squeezing or bending sensor cables.
When alarm triggers, troubleshoot root cause first; do not simply mute alarms.
Do not open chassis cover while powered‑on. Maintenance and repair shall be perｆormed by manufacturer‑authorized engineers.
When supplemental oxygen is applied, monitor oxygen concentration to prevent oxygen toxicity.
Lock casters before nursing operations.
Perｆorm periodic preventive maintenance; retire device upon end of service life。
九、存储条件 Storage Conditions
中文环境温度：‑10℃～+55℃； 相对湿度：≤93%，无凝露； 大气压力：500hPa‑1060hPa； 存储环境通风、干燥，避免阳光直射、粉尘、腐蚀性气体，避免剧烈撞击。
EnglishAmbient temperature:‑10℃～+55℃; Relative humidity: ≤93%, non‑condensing; Atmospheric pressure:500hPa‑1060hPa; Store in well‑ventilated dry place, avoid direct sunlight, dust, corrosive gas and heavy impact.
十、说明书核心摘要 IFU Core Summary
中文戴维 YP‑100 / YP‑600 婴儿培养箱属于 Ⅲ 类医用电气设备，通过温控、加湿构建新生儿中性热环境；YP‑600 拓展光疗、血氧、称重功能。设备用于早产儿、病弱儿保育及高胆红素血症光疗。操作人员须熟悉全部报警、参数设置、维护消毒流程；传感器、过滤器为消耗件需定期更换；光疗务必防护眼睛；仅使用蒸馏水加湿；禁止有机溶剂擦拭透明舱体；故障不可屏蔽报警；存储运输防潮防撞击；严格遵照注册说明书开展临床使用，本资料仅为信息整理，不能替代原厂纸质 IFU 说明书。
EnglishDavid YP‑100 / YP‑600 Infant Incubator is Class III medical electrical equipment. It builds neonatal neutral thermal environment via temperature & humidity regulation. YP‑600 extends functions including phototherapy, SpO₂ monitoring and weighing. Intended for care of premature / sickly neonates and phototherapy for hyperbilirubinemia. Operators must be familiar with alarms, parameter configuration, disinfection and maintenance. Sensors and filters are consumables requiring regular replacement. Eye protection is mandatory for phototherapy. Only distilled water for humidification. Organic solvents are forbidden for acrylic hood cleaning. Alarms must not be muted without troubleshooting. Keep dry and avoid heavy impact during storage & transportation. This document is summary reference only and cannot replace original manufacturer‑issued paper IFU.
免责提示：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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