厂家供应贝朗赛福乐无针输液接头409100CN,4097145N
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厂家供应贝朗赛福乐无针输液接头409100CN,4097145N
桂经理19117326863微xin同号
桂经理19117326863微xin同号
产品名称 无针输液接头Safeflow, Safeflow Extension Set, Safeflow Y-Extension Set
管理类别 第三类
型号规格 409100CN，4097154，4097154N，4097145N，4097148N，4097145，4097148。
结构及组成/主要组成成分 由外壳、安全阀、内圆锥接头和外圆锥接头组成，带/不带延长管、保护套和止逆阀。外壳（含内圆锥接头和外圆锥接头）材料为聚碳酸酯，安全阀材料为硅胶。延长管包含的组件包括管路、Y型连接件、止流夹和鲁尔接头，其中管路材料为聚氨酯，Y型连接件材料为非塑化聚氯乙烯，止流夹材料为聚碳酸酯，鲁尔接头材料为甲基丙烯酸甲酯-丙烯腈-丁二烯-苯乙烯。保护套材料为聚乙烯。止逆阀包含的组件为近延长管端外壳、止逆膜和远延长管端外壳，近延长管端外壳材料为甲基丙烯酸甲酯-丙烯腈-丁二烯-苯乙烯，止逆膜材料为硅胶，远延长管端外壳材料为苯乙烯-丙烯腈。
适用范围/预期用途 409100CN通过与鲁尔接头连接用于抽吸、注射或重力输液，其它型号用于无针输液、输血、血样抽吸和间歇性注射。
贝朗 Safeflow（赛福乐）无针输液接头
注册证号：国械注进 20193141827
产品英文：Safeflow, Safeflow Extension Set, Safeflow Y‑Extension Set 型号：409100CN、4097154、4097145、4097148 及 N 后缀系列
1、工作原理 Working Principle
中文：依靠内置硅胶安全阀（单向阀）机械结构，鲁尔接头插接挤压开启阀腔实现液路导通；断开连接后，安全阀自动回弹闭合，形成密闭无针通路；部分型号具备正压位移效果，断开瞬间产生微量推送液，抑制血液反流，降低导管堵管风险，全程无需钢针穿刺，构建密闭输液系统。 English: Relying on the mechanical structure of built‑in silicone safety valve (one‑way valve). The luer fitting squeezes and opens the valve chamber to open fluid path when connected. After disconnection, the safety valve rebounds and closes automatically to ｆorm a closed needle‑free access. Some models deliver small‑volume positive‑displacement flush upon disconnection to inhibit blood reflux and reduce catheter occlusion risk. No steel needle puncture is required to establish a closed infusion systemB. Braun。
2、产品功能 Product Functions
中文
替代肝素帽，实现无针注射、输液、输血、血样采集；
建立密闭静脉通路，可反复多次鲁尔接头插拔；
正压抑制血液反流，维护导管通畅；
适配注射器、输液器、延长管，用于血管通路装置的给药与冲封管。
English
Replace heparin cap for needle‑free injection, infusion, blood transfusion and blood sampling;
Establish closed intravenous access for repeated luer connections and disconnections;
Positive‑displacement function inhibits blood reflux and maintains catheter patency;
Compatible with syringes, infusion sets and extension tubing for medication administration and catheter flush‑lock of vascular access devicesbbraun.ie。
3、产品特点 Product Features
中文
无针密闭设计，避免针刺伤，降低院内感染风险；
安全阀硅胶材质，外壳聚碳酸酯，不含 DEHP 增塑剂，生物相容性好；
有基础款、带延长管、Y 型延长管多种构型可选；
鲁尔标准接口，兼容各类医用输液耗材；
一次性无菌使用，环氧乙烷灭菌；
透明外壳便于观察液路，可目视确认冲洗效果B. Braun。
English
Needle‑free closed‑system design to prevent needlestick injuries and reduce nosocomial infection risk;
Silicone safety valve, polycarbonate housing, DEHP‑free, good biocompatibility;
Multiple configurations available: basic connector, straight extension set, Y‑type extension set;
Standard luer interface, compatible with mainstream IV consumables;
Single‑use sterile device, ethylene‑oxide sterilized;
Transparent housing for visual inspection of fluid path and flush confirmationB. Braun。
4、技术参数 Technical Parameters
表格
| 中文 | English |
|---|---|
| 注册类别：Ⅲ 类进口医疗器械 | Regulatory Class: Class Ⅲ Imported Medical Device |
| 灭菌方式：环氧乙烷灭菌 | Sterilization: Ethylene Oxide (EO) |
| 材质：外壳：聚碳酸酯；安全阀：硅胶；延长管：聚氨酯；保护套：聚乙烯 | Materials: Housing‑Polycarbonate; Safety Valve‑Silicone; Extension Tubing‑Polyurethane; Protector‑Polyethylene |
| 接口：标准鲁尔锁定接头 | Interface: Standard Luer‑Lock |
| 预充容积：约 0.15‑0.22 mL（随型号变化） | Priming Volume: approx. 0.15‑0.22 mL (model‑dependent)B. Braun |
| 最大耐受压力：依据型号，最高 400 psi（造影高压注射款） | Max Pressure Rating: up to 400 psi for power‑injection compatible modelsB. Braun |
| 货架有效期：36 个月 | Shelf‑life: 36 months |
| 一次性使用，不可重复复用 | Single‑use only, non‑reusable |
5、使用方法 Operating Method
中文
检查包装完整性、有效期，无菌条件下拆开外包装；
取下两端保护护套；
将接头近端与中心静脉 / 外周静脉导管鲁尔接头旋紧连接；
每次接入前充分消毒接头的注射接口，待干；
将注射器 / 输液器鲁尔接头旋入接头，进行给药、输液、采血；
操作完成后，按规范使用生理盐水脉冲冲管，完成封管；
按院内制度定期更换接头；一旦污染、脱落、破损立即更换；
一次性使用，严禁重复灭菌复用。
English
Inspect package integrity and expiry date; open under aseptic condition.
Remove protective caps from both ends.
Tight‑connect the proximal end of connector to luer hub of peripheral or central venous catheter.
Thoroughly disinfect the access port before each connection and allow full drying.
Screw in syringe / infusion‑set luer fitting for medication delivery, infusion or blood collection.
After procedure, perｆorm pulsed saline flush and catheter lock following hospital protocol.
Replace connector periodically per institutional policy. Replace immediately if contaminated, disconnected or damaged.
Single‑use only. Do not re‑sterilize or reuse。
6、适应症 Indications
中文 409100CN：与鲁尔接头连接，用于抽吸、注射、重力输液； 其余型号：用于无针输液、输血、血样抽取、间歇性给药； 适配 PICC、CVC、外周留置针等各类血管通路装置，建立密闭输液通路，用于静脉给药、冲管、封管操作。
English Model 409100CN: For aspiration, injection and gravity infusion via luer connection. Other models: Needle‑free infusion, blood transfusion, blood sampling and intermittent medication administration. Intended for use with vascular access devices including PICC, CVC and peripheral IV catheters to establish closed intravenous access for IV medication, catheter flushing and locking。
7、禁忌症 Contraindications
中文
对产品材质（聚碳酸酯、硅胶、聚氨酯等）有已知过敏史患者禁用；
穿刺部位严重感染、破溃，不适合留置血管通路的情况，不得使用；
包装破损、灭菌失效，禁止使用。
English
Contraindicated for patients with known hypersensitivity to device materials (polycarbonate, silicone, polyurethane etc.).
Do not apply when insertion site presents severe infection or skin breakdown where vascular access cannot be maintained.
Forbidden to use if package is damaged or sterility compromised.
8、注意事项 Precautions
中文
本品一次性使用，使用后按医疗废弃物处置，禁止重复使用；
每次穿刺接入前必须对接头端口充分消毒，待消毒液完全干燥再连接，降低血流感染风险；
操作全程严格执行无菌操作；
冲管建议使用生理盐水，遵循医疗机构冲封管规范；
接头出现漏液、裂纹、回血残留、污染时，必须立即更换；
不可用于皮下、肌肉注射，血管通路液路连接；
禁止超压力限值进行高压注射（非高压款不可做 CT 高压造影推注）；
若发生导管堵塞，禁止暴力推注，应按导管堵管流程处置；
仅在有效期内使用。
English
Single‑use only. Dispose as bio‑hazardous medical waste after use. Reuse is prohibited.
Disinfect access port thoroughly before every connection; allow antiseptic to dry completely prior to connection to reduce bloodstream infection risk.
Strict aseptic technique shall be followed throughout manipulation.
Use normal saline for catheter flush per institutional flush‑lock protocol.
Immediately replace connector in case of leakage, cracking, residual blood or contamination.
For intravenous access connection only; not for subcutaneous or intramuscular injection.
Do not exceed rated pressure; non‑power‑injection‑ready models shall NOT be used for CT contrast power injection.
Never force flush an occluded catheter; follow institutional protocol for catheter occlusion management.
Use only within expiry date.
9、储存条件 Storage Conditions
中文：存放于阴凉干燥通风处，避免阳光直射、高温、潮湿；远离腐蚀性化学品；环境温度 5‑40℃；相对湿度 20%‑80%；不可挤压外包装。 English: Store in cool, dry and well‑ventilated area. Keep away from direct sunlight, high temperature, humidity and corrosive chemicals. Ambient temperature: 5‑40℃; Relative humidity: 20%‑80%. Avoid heavy compression of outer package.
10、说明书核心摘要 Core IFU Summary
中文 本产品为环氧乙烷灭菌的一次性 Ⅲ 类医疗器械，用于静脉血管通路的密闭式无针连接，实现输液、给药、采血；依靠内置硅胶安全阀实现无针反复连接，部分型号具备正压防回血；必须无菌操作，每次使用前消毒接头端口；一次性使用，严禁复用；包装破损、过期禁用；对材质过敏者禁用；接头定期更换，漏液污染立刻更换；储存于干燥阴凉环境，有效期 36 个月。
English This is EO‑sterilized single‑use Class Ⅲ medical device. It provides closed needle‑free connection for intravenous vascular access for infusion, medication delivery and blood sampling. Built‑in silicone safety valve enables repeated needle‑free connections; selected models offer positive displacement to prevent blood reflux. Aseptic technique is mandatory; disinfect port before every access. Single‑use only, reuse prohibited. Do not use if package damaged or expired. Contraindicated for material‑allergic patients. Replace connector on schedule; replace immediately upon leakage or contamination. Store in cool‑dry environment, shelf‑life 36 months.
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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