厂家供应戴维医用空氧混合器KY-20A,KY-10B,KY-20B
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品牌名称：$brandModel.Title型号： 原产地：中国大陆 医疗器械注册号(批文)：浙械注准20182080047更新时间：2026/10/16 11:11:09
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厂家供应戴维医用空氧混合器KY-20A,KY-10B,KY-20B
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
KY-10A、KY-20A、KY-30A、KY-10B、KY-20B、KY-30B。
结构及组成/主要组成成分
产品由主体、流量计、硅胶管、医用低压挠性软管、固定支架及湿化瓶（适用于KY-10B、KY-20B、KY-30B）组成。
适用范围/预期用途
产品用于对空氧混合气体的氧浓度和流量进行调节和控制，配有湿化瓶的混合器可对气体进行湿化。
一、工作原理 Principle
中文设备为纯气动控制，无需外接电源。医用压缩空气与医用氧气两路气源输入，内部精密比例阀根据旋钮设定，自动调节两种气体的进气配比，混合生成目标氧浓度的混合气体；内置气动压力传感机构，当气源压力异常、气源中断时触发气动哨声报警；输出端流量计独立控制输出流量；B 型号可经湿化瓶对混合气体进行湿化处理后输出，无电气元器件，完全依靠气压驱动完成配比、报警、流量调节全流程。
EnglishThis device adopts full‑pneumatic control without external power supply. Medical compressed air and medical oxygen are fed into two gas inlets. The internal precision proportional valve automatically adjusts the intake ratio of the two gases according to knob setting to produce mixed gas with target oxygen concentration. Built‑in pneumatic pressure sensor triggers whistle alarm under abnormal gas pressure or gas supply interruption. Output flow is independently controlled by flowmeter. Model‑B versions humidify mixed gas via humidifier bottle before delivery. The whole process including gas proportioning, alarm and flow adjustment is driven purely by gas pressure without electric components。
二、功能 Function
中文
将医用空气、医用氧气按设定比例混合，输出 21%‑100% 连续可调氧浓度的混合气体。
独立调节输出气体流量，氧浓度与流量调节互不干扰。
气源压力异常、供气中断时气动哨声报警。
KY‑10B、KY‑20B 配套湿化瓶，可完成输出气体湿化。
可开放式供氧，也可与婴儿培养箱、辐射保暖台、氧罩、CPAP、复苏器、呼吸机、分娩仪配套使用，用于氧疗供气。
English
Mix medical air and oxygen at preset ratio, deliver mixed gas with continuously adjustable oxygen concentration from 21%‑100%.
Independently adjust output gas flow; oxygen concentration setting does not interfere with flow adjustment.
Pneumatic whistle alarm for abnormal inlet gas pressure or gas supply failure.
KY‑10B & KY‑20B equipped with humidifier bottle to humidify output gas.
Support open oxygen delivery; compatible with infant incubator, radiant warmer, oxygen hood, CPAP, resuscitator, ventilator and labour analgesia device for oxygen therapy gas supply.
三、产品特点 Product Features
中文
全气动结构，无需电源，断电场景仍可工作。
氧浓度 21%‑100% 连续可调，浓度精度 ±3% O₂(V/V)。
氧浓度、流量分开调节，互不影响，操作简单。
内置气源故障气动报警，哨声报警声压＞57dB (A)。
零反向气流，防止氧气、空气气源互相倒灌。
KY‑20A/KY‑20B 双流量计双路输出，可同时供给两路；KY‑10B 单路输出。
KY‑10B、KY‑20B 集成湿化瓶，直接实现气体湿化；KY‑20A 无湿化瓶。
体积小巧，可支架固定于病床、吊塔，适配新生儿 NICU 病房使用。
English
Fully pneumatic design, no power input required; operable under power‑failure condition.
Continuously adjustable oxygen concentration: 21%‑100%, accuracy ±3%O₂(V/V).
Separate adjustment for oxygen concentration and flow without mutual interference, user‑friendly operation.
Built‑in pneumatic alarm for gas source failure; alarm sound pressure＞57dB(A).
Zero reverse airflow, preventing back‑flow between oxygen and air inlet ports.
KY‑20A / KY‑20B: dual‑flowmeter dual‑output for two patient circuits; KY‑10B: single‑output.
KY‑10B & KY‑20B integrated with humidifier bottle for gas humidification; KY‑20A without humidifier bottle.
Compact dimension, mountable on bed rail or ceiling pendant; ideal for neonatal NICU wards.
四、技术参数 Technical Specifications
表格
| 项目 Item | 中文 | English |
|---|---|---|
| 氧浓度调节范围 | 21%～100%O₂ | O₂ concentration range:21%‑100% |
| 氧浓度精度 | ±3%O₂(V/V) | O₂ concentration accuracy: ±3%O₂(V/V) |
| 输入气源压力 | 207kPa‑517kPa | Inlet gas pressure:207kPa‑517kPa |
| 报警触发压力差 | 138‑180kPa，气源中断、超压 560±40kPa 报警 | Alarm trigger: pressure difference 138‑180kPa, gas cut‑off, overpressure 560±40kPa |
| 报警声压级 | ＞57dB(A) | Alarm sound pressure:＞57dB(A) |
| 反向气流 | 零反向气流 | Zero reverse airflow |
| 流量范围 KY‑10B | 0‑18L/min (单流量计) | Flow KY‑10B:0‑18L/min(single flowmeter) |
| 流量范围 KY‑20A/KY‑20B | 两路各 0‑18L/min，双流量计 | Flow KY‑20A/KY‑20B:0‑18L/min per channel, dual flowmeter |
| 结构配置 | KY‑20A：主体 + 双流量计，无湿化瓶KY‑10B：主体 + 单流量计 + 湿化瓶KY‑20B：主体 + 双流量计 + 湿化瓶 | ConfigurationKY‑20A:main body+dual flowmeter, no humidifier bottleKY‑10B:main body+single flowmeter+humidifier bottleKY‑20B:main body+dual flowmeter+humidifier bottle |
| 设备重量 | 约 0.84‑0.87kg | Weight:approx.0.84‑0.87kg |
| 设备类别 | Ⅱ 类医疗器械 | Device Class:Class Ⅱ Medical Device |
数据来源产品注册标准 YZB / 浙 4135‑2014
五、使用方法 Operating Instructions
中文
将设备固定在支架 / 吊塔上，分别连接医用压缩空气、医用氧气气源接口，确认进气压力在 207‑517kPa。
KY‑10B/KY‑20B：湿化瓶加入无菌注射用水至刻度线，拧紧；KY‑20A 直接外接后端管路。
开启两路气源，旋转浓度调节旋钮设置目标氧浓度。
调节流量计旋钮，设置临床需要输出流量。
将输出管路连接患者端或配套设备（氧罩、CPAP、复苏器等），开始氧疗。
使用中若听到哨声报警，立即检查两路气源压力、供气是否中断，排除故障。
使用结束，关闭气源，泄压，拆卸管路；湿化瓶按院感规范清洁消毒。
定期校验氧浓度精度。
English
Mount the device onto support or ceiling pendant; connect medical compressed air and medical oxygen inlets respectively. Confirm inlet pressure within 207‑517kPa.
For KY‑10B/KY‑20B: fill humidifier bottle with sterile water to marked level and tighten. For KY‑20A, connect output pipeline directly.
Turn on both gas supplies; rotate concentration knob to set target oxygen concentration.
Adjust flowmeter knob to set clinical output flow rate.
Connect output tubing to patient interface or compatible equipment (oxygen hood, CPAP, resuscitator etc.) to initiate oxygen therapy.
If whistle alarm sounds during operation, inspect gas inlet pressure and gas supply status immediately and troubleshoot.
Upon completion: shut off gas sources, release pressure and disconnect tubing. Clean and disinfect humidifier bottle following hospital infection‑control protocol.
Calibrate oxygen concentration accuracy periodically.
六、适应症 Indications
中文用于临床氧疗，调节、控制医用空气与氧气混合气体的氧浓度及输出流量，为患者提供可控浓度的吸入氧；适用于新生儿、婴幼儿及成人氧疗；可开放式给氧，或配合婴儿培养箱、辐射保暖台、氧罩、CPAP、复苏器、呼吸机、分娩仪等设备使用，多用于新生儿重症监护病房、病房氧疗场景。
EnglishFor clinical oxygen therapy. Regulate and control oxygen concentration and flow rate of mixed medical air‑oxygen gas to deliver inhaled oxygen of controlled concentration for patients. Applicable for neonates, infants and adults oxygen therapy. Supports open oxygen delivery or working with infant incubator, radiant warmer, oxygen hood, CPAP, resuscitator, ventilator and labour analgesia device. Widely used in NICU and general ward oxygen therapy.
七、禁忌症 Contraindications
中文高血氧症患者禁用。
EnglishContraindicated for patients with hyperoxaemia.
八、注意事项 Precautions
中文
仅可使用医用氧气、医用压缩空气，禁止接入其他气体。
输入气源压力必须维持 207‑517kPa，压力超出范围会造成浓度不准、报警异常。
报警仅提示气源故障，不能替代血氧监护，临床仍需监测患者血氧饱和度。
禁止油污、油脂接触设备气路部件，氧气相关器件禁油。
湿化瓶仅使用无菌注射用水，水位不可超过最高刻度，定期更换，做好消毒，防止交叉感染。
不可拆解设备本体，内部阀件需由厂家授权人员维护校准。
禁止超最大流量使用，避免输出氧浓度偏差。
使用前检查无漏气；出现浓度漂移、报警失效立即停止使用，送修。
不得用于麻醉气体混合，空气 + 氧气混合。
设备无治疗监护功能，需配套生命体征监护设备使用。
English
Only medical oxygen and medical compressed air shall be used; other gases are prohibited.
Inlet gas pressure shall be kept within 207‑517kPa; out‑of‑range pressure causes concentration error and abnormal alarm.
Gas‑source alarm cannot replace patient SpO₂ monitoring; clinical blood oxygen monitoring is mandatory.
Keep gas path components free of oil and grease; oxygen‑contact parts are oil‑free requirement.
Only sterile water for injection for humidifier bottle; water level shall not exceed maximum mark. Replace and disinfect regularly to avoid cross‑infection.
Do not disassemble main unit; internal valve maintenance & calibration shall be perｆormed by manufacturer‑authorized personnel only.
Do not operate above maximum flow rating to prevent oxygen concentration deviation.
Inspect for gas leakage before use. Stop operation immediately and send for repair if concentration drift or alarm malfunction occurs.
Not for anaesthetic gas mixing; only for air‑oxygen blending.
This device has no patient monitoring function; use together with vital‑sign monitor.
九、存储条件 Storage Conditions
中文环境温度：‑10℃～+55℃；相对湿度：≤80% RH；大气压力：70kPa‑106kPa；存放于通风干燥室内，避免阳光直射、粉尘、腐蚀性气体，避免磕碰撞击；设备应防尘保护存放，管路部件防止挤压变形。
EnglishAmbient temperature:‑10℃～+55℃; Relative humidity: ≤80%RH; Atmospheric pressure:70kPa‑106kPa. Store in well‑ventilated dry indoor space. Avoid direct sunlight, dust, corrosive gas and mechanical impact. Keep dust‑proof protection; prevent tubing extrusion and deｆormation.
十、说明书核心摘要 IFU Core Summary
中文本产品为 Ⅱ 类无源气动医疗器械，由主体、流量计、软管、支架，B 型号含湿化瓶组成；用于空气‑氧气混合输出可控氧浓度气体，用于临床氧疗；纯气动无需供电；氧浓度 21‑100% 可调，精度 ±3%；气源异常气动哨声报警；禁忌症：高血氧症禁用；必须使用合格医用气源；湿化瓶做好院感管控；不可自行拆解，定期专业校准；存放于干燥通风环境。配套管路、湿化瓶按院感要求消毒更换。
EnglishThis is Class‑Ⅱ passive pneumatic medical device, composed of main body, flowmeters, flexible tubing and mounting bracket. Model‑B includes humidifier bottle. It blends medical air and oxygen to deliver gas with controlled oxygen concentration for clinical oxygen therapy. Fully pneumatic without power supply. Oxygen concentration adjustable 21‑100%, accuracy ±3%. Pneumatic whistle alarm for gas source failure. Contraindication: hyperoxaemia. Qualified medical gas source must be adopted. Strict infection control for humidifier bottle. No unauthorized disassembly; periodic professional calibration required. Store under dry and ventilated condition. Tubing and humidifier bottle shall be disinfected or replaced per hospital infection‑control procedure.
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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