厂商供应戴维新生儿黄疸治疗灯YG-Ⅱ
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厂商供应戴维新生儿黄疸治疗灯YG-Ⅱ
桂经理19117326863微xin同号
桂经理19117326863微xin同号
管理类别
第二类
型号规格
YG-Ⅰ、YG-Ⅱ、YG-Ⅲ、YG-IV
结构及组成/主要组成成分
新生儿黄疸治疗灯（以下简称黄疸灯）由灯箱组件、吸盘（仅适用于YG-I、YG-II、YG-III）、电源适配器（仅适用于YG-III）、控制仪（仅适用于YG-IV）和支臂组件【仅适用于YG-III（可选件）、YG-IV】组成。
适用范围/预期用途
产品预期通过发射主辐射光谱处于400nm至550nm范围内的可见光，来降低新生儿体内的胆红素浓度。
1、工作原理 / Working Principle
中文本设备采用 LED 光源发射 400‑550nm 有效可见光光谱（胆红素最佳吸收波段），通过光异构化光化学反应，将新生儿体内脂溶性未结合胆红素转化为水溶性光产物，光产物无需肝脏代谢，可直接经胆汁、尿液排出体外，从而降低血清胆红素浓度，实现光疗退黄治疗。
EnglishThis device adopts LED light source to emit effective visible‑light spectrum of 400‑550 nm (optimal absorption band for bilirubin). Through photoisomerization photochemical reaction, lipid‑soluble unconjugated bilirubin in neonates is converted into water‑soluble photoproducts. These photoproducts can be excreted directly via bile and urine without hepatic ｍmbedbolism, thus reducing serum bilirubin concentration for jaundice phototherapy treatment.
2、功能 / Functions
中文
输出胆红素治疗波段可见光，用于新生儿高胆红素血症光疗；
治疗计时功能，累计记录光疗时长；
LED 蓝光光源输出，提供稳定胆红素辐照度；
可吸附安装于婴儿培养箱罩顶部，配合培养箱完成新生儿光疗治疗宁波戴维医...。
English
Output visible light within therapeutic bilirubin band for phototherapy of neonatal hyperbilirubinemia;
Therapy timer function to accumulate total phototherapy duration;
Stable bilirubin irradiance output by blue‑LED light source;
Suction‑cup mounting on top hood of infant incubator to perｆorm neonatal phototherapy together with incubator宁波戴维医....
3、产品特点 / Product Features
中文
小巧紧凑，底部配置吸盘，可直接吸附固定在婴儿培养箱恒温罩顶部，安装便捷；
LED 光源，发热量低，光效高，使用寿命长；
胆红素辐照度输出稳定，照射区域照度分布均匀；
自带计时模块，可记录光疗累计时间；
适配主流婴儿培养箱、婴儿辐射保暖台，临床部署灵活。
English
Compact size with bottom suction‑cups for easy direct mounting on incubator hood;
Low‑heat high‑efficiency LED light source with long service life;
Stable bilirubin irradiance output and uniｆorm illumination over effective irradiation area;
Built‑in timer module for accumulated phototherapy time recording;
Compatible with mainstream infant incubators and radiant warmers for flexible clinical deployment.
4、技术参数 / Technical Specifications
表格
| 中文 | English |
|---|---|
| 型号：YG‑Ⅱ | Model: YG‑Ⅱ |
| 光源：LED 蓝光 | Light source: Blue LED |
| 主辐射光谱范围：400 nm‑550 nm | Main emission spectrum: 400 nm‑550 nm |
| 胆红素总辐照度平均值：≥0.8 mW/cm² | Average bilirubin total irradiance: ≥0.8 mW/cm² |
| 总辐照度 Ebi：≥1.0 mW/cm² | Total irradiance Ebi: ≥1.0 mW/cm² |
| 安装方式：底部吸盘吸附于培养箱罩顶部 | Mounting: Suction‑cup mounting on incubator hood top |
| 组成：灯箱组件、吸盘 | Components: Lamp‑box assembly, suction cups |
| 电气分类：Ⅱ 类医用设备 | Electrical classification: Class Ⅱ medical device |
| 计时：光疗时间累计计时 | Timer: Accumulated phototherapy timing |
5、使用方法 / Operation Method
中文
将黄疸治疗灯通过底部吸盘牢固吸附在婴儿培养箱恒温罩顶部；确认吸附牢固无松动；
接通设备电源；确认新生儿双眼佩戴遮光眼罩、会阴部做好遮盖保护；
将新生儿放置在培养箱内光源有效照射区域中心位置；
开启设备电源开关，启动光疗，计时器自动开始累计治疗时长；
按临床医嘱执行光疗，定时监测新生儿胆红素、体温、皮肤状态；
光疗结束后关闭电源，记录光疗总时长，取下遮光用品，移除设备或保持就位。
English
Firmly attach the phototherapy light to the top hood of infant incubator by bottom suction‑cups, ensure secure mounting without looseness.
Connect power supply. Ensure neonate’s eyes are covered with phototherapy eye‑shield and perineum is properly protected.
Place neonate at center of effective irradiation zone inside incubator.
Turn on power switch to start phototherapy; timer automatically accumulates treatment duration.
Perｆorm phototherapy per clinical physician’s order; regularly monitor neonatal bilirubin, body temperature and skin condition.
Power off after therapy completion, record total phototherapy time, remove protective eye‑shield, then remove or keep the unit in‑situ.
6、适应症 / Indications
中文用于婴儿培养箱内新生儿高胆红素血症，发射 400‑550nm 可见光，降低新生儿体内胆红素浓度，进行新生儿黄疸光疗治疗。
EnglishIndicated for phototherapy treatment of neonatal hyperbilirubinemia within infant incubator. Emits visible light of 400‑550 nm spectrum to reduce bilirubin concentration in neonates for neonatal jaundice management.
7、禁忌症 / Contraindications
中文
直接胆红素升高（梗阻性黄疸）患者禁止使用光疗；
对光疗存在明确禁忌的新生儿，遵临床医师判断禁止使用；
皮肤严重破损、特殊光敏疾病患儿禁用。
English
Contraindicated for neonates with elevated direct bilirubin (obstructive jaundice).
Do NOT use for neonates with clinically confirmed contraindications to phototherapy, subject to physician assessment.
Contraindicated for infants with severe skin injury or specific photosensitive diseases.
8、注意事项 / Precautions
中文
仅可放置在婴儿培养箱罩外侧顶部，禁止直接接触新生儿身体；
光疗期间新生儿眼睛必须佩戴专用遮光眼罩，会阴部应予以遮盖，避免光损伤；
定期检查吸盘吸附可靠性，防止设备坠落；
定时监测新生儿体温、皮肤、脱水情况，按需补液；
禁止液体泼溅设备灯箱，设备外壳仅可使用医用中性消毒剂擦拭；
光源衰减后辐照度下降，应定期检测胆红素辐照度，必要时更换光源组件；
必须由经过培训医护人员操作，严格遵从临床光疗指南；
不可用于人体其他部位非黄疸治疗用途。
English
Mount only on the outer top of incubator hood. NO direct contact with neonate’s body.
Neonatal eyes must be covered by dedicated phototherapy eye‑shield and perineum protected during phototherapy to prevent light‑induced injury.
Regularly inspect suction‑cup fastening status to prevent unit falling hazard.
Monitor neonate’s body temperature, skin condition and dehydration status regularly; provide fluid supplementation as needed.
Prevent liquid splashing onto lamp‑box. Wipe housing only with medical neutral disinfectant.
Bilirubin irradiance decreases with light‑source aging. Perｆorm periodic irradiance testing; replace light‑source assembly when required.
Operate only by trained medical personnel in accordance with clinical phototherapy guidelines.
Not for non‑jaundice treatment on other human body parts.
9、存储条件 / Storage Conditions
中文环境温度：‑10℃～+55℃； 相对湿度：≤80%，无冷凝； 大气压力：70 kPa‑106 kPa； 存放于干燥通风室内，避免阳光直射、粉尘、腐蚀性气体，避免剧烈撞击与跌落。
EnglishAmbient temperature: ‑10℃～+55℃； Relative humidity: ≤80%, non‑condensing； Atmospheric pressure: 70 kPa‑106 kPa； Store in dry and ventilated indoor environment. Avoid direct sunlight, dust, corrosive gas, heavy impact and dropping.
10、说明书核心声明 / Core IFU Statement
中文
产品类别：第二类医疗器械；注册人：宁波戴维医疗器械股份有限公司；
本设备仅用于临床新生儿黄疸光疗，不能替代药物、换血等其他治疗手段；
光疗效果个体存在差异，需结合血清胆红素检验与医师临床综合评估；
全部操作、维护请参照原厂正式纸质说明书。
English
Product classification: Class Ⅱ medical device; Registrant: Ningbo David Medical Device Co., Ltd.
This device is intended solely for clinical neonatal jaundice phototherapy and cannot replace pharmacotherapy, exchange transfusion or other therapies.
Phototherapy efficacy varies among individuals; treatment shall be guided by serum bilirubin laboratory results and comprehensive physician clinical assessment.
All operation and maintenance shall comply with official original printed 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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