厂家供应英特赛克呼吸麻醉管路及配件
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厂家供应英特赛克呼吸麻醉管路及配件
桂经理19117326863微xin同号
桂经理19117326863微xin同号
产品名称 呼吸麻醉管路及配件Ventilator, Anaesthetic Breathing Systems and Accessories
管理类别 第二类
型号规格 见附页
结构及组成/主要组成成分 该产品包括呼吸机管路及配件和麻醉机管路及配件。呼吸机管路及配件包括波纹管，可伸缩管和平纹管呼吸回路。配件包括积水杯，增湿罐，二氧化碳监测管，鼻罩，鼻塞，单管和接头。麻醉机管路及配件包括波纹管，可伸缩管和平纹管呼吸回路，配件包括麻醉面罩，APL阀，气囊，积水杯，呼吸过滤器，单管和接头。一次性使用
适用范围/预期用途 呼吸麻醉管路及配件用于患者呼吸治疗。
| 订货号 | 产品简述 |
|---|---|
| 2108000 | 成人波纹管回路 1.8m+2L 储气囊 + APL 阀（最常用） |
| 2161000 | 成人可伸缩麻醉回路 1.6m |
| 4700000 | 成人同轴 UniFlow 回路 1.8m |
| 5809000 | 小儿麻醉回路，15mm 接口 |
| 2107000 | 成人波纹管回路，不带气囊 |
| 2150000 | 新生儿婴儿麻醉回路 10mm 接口 |
| 订货号 | 产品简述 |
|---|---|
| 3001000 | 成人波纹管呼吸机回路 1.8m，双积水杯 |
| 3002000 | 成人可伸缩呼吸机回路 |
| 3005000 | 儿童呼吸机回路 15mm |
| 3008000 | 新生儿呼吸机回路 10mm |
积水杯：2201000（成人）、2202000（小儿）
储气囊：2L、1L、0.5L 多种订货号
APL 压力调节阀、各类接头、Y 型件、二氧化碳采样管
麻醉面罩（ClearLite 系列成人 / 小儿 / 新生儿）
呼吸过滤器、增湿罐、鼻罩、鼻塞、单管延长管
1、工作原理 Working Principle
中文 该产品为气体通路管路组件，搭建麻醉机 / 呼吸机与患者气道之间的密闭气体传输通道；将麻醉机、呼吸机输出的新鲜气体、麻醉混合气体输送至患者，同时将患者呼出气体导出；积水杯冷凝收集回路内冷凝水，各类接头、面罩、气囊、过滤器实现气路转接、储气、过滤，保障通气回路密闭性，完成机械通气、麻醉呼吸的气体通路传输功能。部分抗菌款管路添加银离子抗菌添加剂，破坏细菌酶活性与细胞壁，抑制管路内微生物增殖，降低交叉感染风险Intersurgi...。
English This product is a gas‑path pipeline assembly, establishing sealed gas transmission channel between anaesthetic machine/ventilator and patient airway. It delivers fresh gas and mixed anaesthetic gas from equipment to patient, and exhausts patient’s exhaled gas. Water traps collect condensed water inside circuit. Connectors, masks, reservoir bags and filters realize gas‑path connection, gas storage and filtration to maintain air‑tightness for mechanical ventilation and anaesthetic respiration. Some anti‑microbial versions adopt silver‑ion additive to disrupt bacterial enzymatic activity and cell wall, inhibit microbial proliferation and reduce cross‑infection riskIntersurgi...。
2、产品功能 Product Functions
中文
构建麻醉、呼吸治疗完整气路回路，传输吸入与呼出气体；
储气囊实现手动辅助通气，储存气体；APL 阀调节回路泄压压力；
积水杯收集管路冷凝水，防止冷凝水误流入患者气道；
面罩、鼻罩、鼻塞完成患者端气道对接；接头实现各部件快速连接；
呼吸过滤器过滤气体中气溶胶、颗粒物；二氧化碳监测管采集呼吸气体样本；
适配呼吸机、麻醉机，用于全麻、术后复苏、重症监护呼吸通气通路搭建。
English
Establish complete gas circuit for anaesthesia and respiratory therapy, transmit inspiratory and expiratory gas.
Reservoir bag stores gas and enables manual assisted ventilation; APL valve adjusts circuit pressure relief.
Water traps collect condensate inside tubing to prevent condensate aspiration into patient airway.
Masks, nasal masks and nasal prongs connect to patient airway; connectors realize quick assembly of components.
Breathing filter filters aerosol and particles; CO₂ sampling tube collects respiratory gas sample.
Compatible with ventilator and anaesthesia machine for general anaesthesia, post‑anaesthesia recovery and ICU respiratory ventilation setup。
3、产品特点 Product Features
中文
一次性无菌使用，环氧乙烷灭菌，避免交叉感染；
管路材质柔韧抗弯折，透明可视，便于观察管路积水、堵塞情况；有无 DEHP 邻苯二甲酸酯可选材质；
规格齐全：成人 22mm、儿童 15mm，含波纹管、平纹管、可伸缩回路，适配不同体重患者；
配套组件完整：积水杯、储气囊、APL 阀、面罩、过滤器、各类接头齐全；部分型号内置银离子抗菌材质；
接头卡扣式密封连接，拆装便捷，防意外脱落漏气；
可伸缩回路压缩包装，节省仓储空间，临床可按需拉伸长度Intersurgi...。
English
Single‑use sterile product sterilized by ethylene oxide to avoid cross‑infection.
Flexible, kink‑resistant transparent tubing for visual inspection of condensate and obstruction; DEHP‑free material optional.
Complete specifications: 22 mm for adult,15 mm for paediatric; corrugated, flat‑walled and extendable circuits for patients of various body weights.
Comprehensive accessories: water traps, reservoir bags, APL valves, masks, filters and various connectors; partial models with silver‑ion anti‑microbial material.
Clip‑in sealed connectors for easy assembly and disassembly, preventing accidental disconnection and gas leakage.
Compact extendable circuit in compressed packaging to save storage space, stretchable for clinical requirementIntersurgi...。
4、技术参数 Technical Parameters
中文
注册类别：Ⅱ 类医疗器械；灭菌方式：环氧乙烷灭菌；使用方式：一次性使用；
管路内径：成人 22 mm，小儿 15 mm；
管路长度：常规≥1.5‑2.0 m（波纹管 / 平纹管 / 可伸缩管多规格）；
储气囊规格：0.5L、1L、2L、3L；
APL 阀压力调节范围：0‑60 cmH₂O；
呼吸过滤器过滤效率≥96%；
工作环境温度：10℃‑40℃；相对湿度 30%‑75%；
组件构成：呼吸管路、积水杯、增湿罐、二氧化碳监测管、面罩、鼻罩、鼻塞、储气囊、APL 阀、过滤器、各类接头（型号规格繁多详见注册附页）。
English
Device Class: Class Ⅱ medical device; Sterilization: Ethylene oxide; Application: Single‑use only.
Tubing inner diameter: 22 mm (adult), 15 mm (paediatric).
Tubing length: ≥1.5‑2.0 m for corrugated / flat‑walled / extendable circuits.
Reservoir bag volume: 0.5 L, 1 L, 2 L, 3 L.
APL valve adjustable pressure range: 0‑60 cmH₂O.
Filtration efficiency of breathing filter ≥96%.
Operating ambient temperature:10℃‑40℃; relative humidity 30%‑75%.
Components: breathing tubing, water trap, humidifier chamber, CO₂ sampling line, mask, nasal mask, nasal prongs, reservoir bag, APL valve, filter and various connectors. Full model list see registration appendix。
5、使用方法 Operation Method
中文
检查包装完整性、灭菌有效期，包装破损、过期禁止使用；
根据患者年龄体重选择对应规格管路、面罩、配件；
将呼吸回路机器端连接麻醉机或呼吸机输出接口；依次装配积水杯、过滤器、储气囊、APL 阀等配件；
患者端 Y 型接头连接面罩 / 气管插管 / 喉罩等气道器械；
组装完成后执行气路漏气测试，确认回路无漏气；
开启麻醉机 / 呼吸机，设置通气参数，开展通气或麻醉；
使用过程定时查看积水杯，及时倾倒冷凝水；
仅供单患者一次性使用，治疗结束后整套废弃，不可重复消毒复用。
English
Inspect package integrity and sterilization expiry date. Do not use if package damaged or expired.
Select proper tubing, mask and accessories according to patient age and weight.
Connect machine‑side port of breathing circuit to anaesthetic machine or ventilator outlet. Assemble water traps, filter, reservoir bag and APL valve sequentially.
Connect patient‑side Y‑piece to mask, endotracheal tube or laryngeal mask airway.
Perｆorm gas leakage test after assembly to confirm air‑tightness.
Power on anaesthetic machine / ventilator, set ventilation parameters and start ventilation or anaesthesia.
Regularly inspect water traps and drain condensate timely during use.
For single‑patient single‑use only. Discard whole set after therapy; re‑sterilization and reuse are prohibited。
6、适应症 Indications
中文 用于医疗机构中，配合麻醉机、呼吸机对患者实施呼吸治疗；适用于全身麻醉术中通气、术后复苏、重症监护机械通气，建立患者与设备之间的呼吸气体传输通路。
English Used in medical institutions together with anaesthetic machine or ventilator for patient respiratory therapy. Indicated for ventilation during general anaesthesia, post‑anaesthesia recovery and intensive‑care mechanical ventilation, establishing respiratory gas transmission path between patient and equipment。
7、禁忌症 Contraindications
中文
无产品直接禁忌症；本产品为气路耗材，不可用于气道完全离断、无法建立有效气道的患者；
对产品材质（PVC、聚丙烯等）已知过敏患者禁止使用对应材质组件。
English
No direct contra‑indications for this device. Not applicable for patients with complete airway disruption where effective airway cannot be established.
Contra‑indicated for patients with known allergy to materials such as PVC, polypropylene.
8、注意事项 Precautions
中文
一次性使用，严禁重复使用、重复灭菌，重复使用会造成交叉感染风险；
使用前务必做漏气测试，管路漏气会造成通气不足、麻醉泄露；
管路严禁弯折挤压，防止管路闭塞造成窒息风险；
积水杯必须朝下放置，及时排空冷凝水，防止冷凝水返流进入患者气道；
必须由经过专业培训的医护人员操作；
包装破损、灭菌失效、组件缺失严禁使用；
选用匹配内径规格配件，不可强行对接不匹配接头，防止漏气、接头脱落；
使用中密切观察患者通气状态，若出现管路堵塞、脱落立即处置；
不可用于超出产品设计压力的通气场景。
English
Single‑use only. Reuse or re‑sterilization is strictly forbidden to avoid cross‑infection risk.
Leakage test must be perｆormed prior to clinical use. Gas leakage may lead to insufficient ventilation and anaesthetic gas escape.
Avoid tubing kinking or compression; tubing occlusion may cause suffocation hazard.
Water traps shall be placed downward; drain condensate timely to prevent back‑flow into patient airway.
Operation shall be perｆormed by professionally trained medical staff.
Do not use if package damaged, sterilization invalid or components missing.
Select matching inner‑diameter accessories. Do not force mismatched connectors to prevent leakage and disconnection.
Closely monitor patient ventilation status during use. Resolve tubing blockage or disconnection immediately.
Do not apply ventilation pressure exceeding product design range.
9、存储条件 Storage Conditions
中文 存储于阴凉干燥通风环境；环境温度 5℃‑40℃；相对湿度 30%‑75%；避免阳光直射，远离热源，禁止重压、挤压包装；远离腐蚀性气体。
English Store in cool, dry and well‑ventilated place. Ambient temperature: 5℃‑40℃; relative humidity:30%‑75%. Avoid direct sunlight and heat source. Prevent heavy compression on package; keep away from corrosive gas.
10、说明书核心摘要 Manual Core Summary
中文 英特赛克呼吸麻醉管路及配件为二类进口一次性无菌呼吸耗材，由呼吸管路、积水杯、储气囊、APL 阀、面罩、过滤器、各类接头等组成，在麻醉机 / 呼吸机与患者之间构建密闭呼吸气路，完成麻醉、机械通气气体传输。成人 22 mm、儿童 15 mm 多规格，环氧乙烷灭菌，仅供单患者一次性使用。使用前核查包装与有效期，组装后进行漏气测试；使用中及时清理冷凝水，防止管路弯折堵塞；禁止复用。储存避开高温、阳光直晒。操作人员为专业医护人员。
English Intersurgical Ventilator, Anaesthetic Breathing Systems and Accessories are Class Ⅱ imported single‑use sterile respiratory consumables, composed of breathing tubing, water traps, reservoir bags, APL valves, masks, filters and various connectors. It builds sealed respiratory gas circuit between anaesthetic machine/ventilator and patient for gas delivery during anaesthesia and mechanical ventilation. Two main sizes: 22 mm for adult and15 mm for paediatric. Sterilized by ethylene oxide for single‑patient use only. Verify package and expiry date before use; perｆorm leakage test after assembly. Drain condensate in time and avoid tubing kinking or blockage. Reuse is prohibited. Store away from high‑temperature and direct sunlight. Operated by qualified medical personnel.
免责声明：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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