厂家贝尔蒙一次性使用加温管路905-00010
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厂家贝尔蒙一次性使用加温管路905-00010
桂经理19117326863微xin同号
桂经理19117326863微xin同号
产品名称 一次性使用加温管路buddy Disposable Set
管理类别 第三类
型号规格 905-00010
结构及组成/主要组成成分 该产品由加温管路框架、自动排气装置、连接管路、内圆锥接头、外圆锥接头、内圆锥接头封盖、外圆锥接头封盖、压力调节阀、单向阀、床单夹、关闭夹组成。
适用范围/预期用途 一次性使用加温管路与本公司配套的输血输液加温仪一起使用,用于输血、输液过程中对液体进行加温。由医护专业人员在临床环境中使用以防止低体温发生。
中文品名:一次性使用加温管路English Name: Disposable Warming Cassette Set品牌厂商:Belmont Medical Technologies(美国贝尔蒙医疗)型号:905-00010配套主机:Belmont Buddy Lite / Buddy Plus 便携式输血输液加温仪注册证号:国械注进 20193140490结构组成:换热卡匣主体、进液管路、出液管路、疏水自动排气膜、单向防反流阀、流量调节夹、鲁尔接头、固定夹;环氧乙烷灭菌,一次性无菌使用
重要区分:905-00010 适配 Buddy 系列小型加温仪;RI-2 大容量输注系统耗材型号为 903-00006,两者不可互换
一、工作原理 Working Principle
中文将一次性加温卡匣管路完整嵌入 Buddy 加温仪加热腔体,输液 / 血液制品流经卡匣内部连续换热通道,通过干式热传导方式吸收加温仪加热板热量,液体被加温至安全生理温度。管路集成疏水型自动排气膜,液体流动过程中析出的微小空气气泡可透过薄膜向外排出,同时阻挡液体渗漏;内置单向阀阻止液体发生倒流。整套流体通路全程密闭无菌,加温后的液体输送至患者静脉,避免低温液体输注引发患者围术期、创伤救治低体温。
EnglishLoad the disposable warming cassette fully into the heating chamber of Belmont Buddy fluid warmer. Infusion fluids and blood products flow through continuous heat exchange channels inside the cassette and absorb thermal energy from the heater plates via dry thermal conduction, so the fluid is warmed to safe physiological temperature. The set integrates hydrophobic automatic vent membrane, which allows micro air bubbles separated from fluid to escape outward while preventing liquid leakage. A built-in check valve prevents fluid backflow. The entire fluid path remains closed and sterile. Warmed fluid is delivered into the patient’s vein to avoid hypothermia caused by cold fluid transfusion during surgery and trauma resuscitation.
二、产品功能 Functions
中文
与 Buddy 便携式加温仪配套,构建干式在线加温流体通道,实现晶体液、胶体液、血液制品输注加温;
疏水排气膜持续排出管路内微气泡,降低空气栓塞风险;
单向阀防止液体反流,稳定输注流向;
标准鲁尔接头,兼容常规血袋、输液袋、静脉留置通路;
配备流量夹,可随时阻断液体流动;附带固定夹,方便术中管路固定;
维持密闭无菌流道,加温过程不破坏流体无菌状态。
English
Cooperate with Buddy portable fluid warmer to form a dry in-line warming channel for heating crystalloids, colloids and blood products during infusion;
Hydrophobic vent continuously removes micro air bubbles inside tubing to reduce air embolism risk;
Check valve prevents fluid backflow and stabilizes infusion direction;
Standard Luer connectors compatible with standard blood bags, IV fluid bags and venous access devices;
Equipped with flow clamp to shut off fluid flow at any time; attached fixing clip facilitates intraoperative tubing fixation;
Maintain closed sterile fluid path without compromising fluid sterility during warming.

三、产品特点 Product Features
中文
近患者端加温设计,换热段距离穿刺点短,加温后热量损耗小,输出液体温度稳定;
干式无水浴换热结构,卡匣内无金属换热元件,不存在金属离子析出风险;
一体式疏水自动排气膜,无需人工反复预充排气,简化临床操作;
内置单向防反流结构,体位变动、管路落差变化不易发生液体倒流;
预成型卡匣框架,安装简单,直接卡入加温腔体,无需人工盘绕管路;
管路组件不含天然乳胶,减少乳胶过敏风险,生物相容性良好;
独立 EO 无菌包装,单人单次使用;重力输注、输液泵输注均可适配;
体积轻便,适配手术室、急诊 ICU、院前创伤转运、产科急救等多场景。
English
Patient-side heating layout. Short distance between heat exchange section and puncture site minimizes heat loss and delivers stable fluid temperature;
Dry water-free heating structure, no mmbedllic components inside cassette, eliminating risk of mmbedl ion elution;
Integrated hydrophobic automatic vent membrane, repeated manual priming and purging are not required to simplify clinical operation;
Built-in anti-reflux valve prevents backflow caused by position change and tubing height difference;
Pre-shaped cassette fframe for easy installation. Simply insert into heating chamber without manual tubing winding;
Latex-free construction lowers latex allergy risk with excellent biocompatibility;
Individually EO sterile packaged for single-patient single use, compatible with gravity infusion and infusion pump delivery;
Lightweight design suitable for operating rooms, emergency ICU, pre-hospital trauma transport and obstetric emergency treatment.

四、技术参数 Technical Specifications
| 中文 | English |
|---|---|
| 产品型号:905-00010 | Model: 905-00010 |
| 适配设备:Belmont Buddy Lite / Buddy Plus 加温仪 | Compatible Device: Belmont Buddy Lite / Buddy Plus Fluid Warmer |
| 换热形式:干式热传导换热通道 | Heat Exchange Form: Dry conductive heat exchange channel |
| 流体通路材质:医用高分子聚合物 | Fluid Path Material: Medical-grade polymer |
| 排气组件:疏水微孔排气膜 | Air Vent Component: Hydrophobic microporous vent membrane |
| 灭菌方式:环氧乙烷(EO) | Sterilization: Ethylene Oxide (EO) |
| 使用属性:一次性使用,严禁复用、二次灭菌 | Usage: Single-use only; reuse and resterilization prohibited |
| 推荐流速区间:5 mL/min ~ 100 mL/min | Recommended Flow Range: 5 mL/min ~ 100 mL/min |
| 货架有效期:3 年 | Shelf Life: 3 years |
| 重要提示:不可单独使用,必须匹配原厂 Buddy 加温主机 | Important Notice: Cannot be used independently; must be matched with original Buddy warmer unit |
五、使用方法 Operation Instructions
中文
使用前核查外包装完整性、无菌屏障及有效期,在洁净区域拆封;
将加温卡匣平整嵌入加温仪加热仓,完全闭合并锁定仓盖;
卡匣上游管路连接输液袋 / 血袋,下游管路连接患者静脉通路;
缓慢打开流量夹,依靠重力或输注泵完成管路预充,系统自动排出微气泡;
启动 Buddy 加温仪,设定目标温度,开始加温输注;
输注过程持续观察管路有无渗漏、排气膜工作状态;
治疗结束后关闭流量夹,停止加温,断开患者端管路;
使用完毕整套管路按感染性医疗废弃物规范处置。
English
Verify package integrity, sterile barrier and expiry date before use; unpack in clean environment;
Insert warming cassette flatly into the heating chamber of the warmer, fully close and lock chamber lid;
Connect upstream tubing to fluid or blood bag; connect downstream tubing to patient venous access;
Slowly open flow clamp, prime tubing via gravity or infusion pump. Micro air bubbles will be purged automatically;
Activate Buddy warmer, set target temperature and start warmed infusion;
Continuously monitor tubing for leakage and normal vent function during transfusion;
Close flow clamp after treatment, stop heating and disconnect patient-side tubing;
Dispose the whole set as regulated biohazard medical waste after use.
六、适应症 Indications
中文本产品需配套 Buddy 便携式输血输液加温仪使用。用于静脉输注过程中对晶体液、胶体液、红细胞类血液制品进行在线加温,预防低温液体输注造成患者低体温。适用场景:外科手术、创伤急救、产科大出血救治、院前患者转运。⚠️ 禁止用于血小板制剂加温输注。
EnglishThis product must be used with Buddy portable blood and fluid warmer. It is applied for in-line warming of crystalloids, colloids and red blood cell products during intravenous infusion to prevent hypothermia induced by cold fluid transfusion. Applicable scenarios: surgical operation, trauma emergency, obstetric massive hemorrhage rescue and pre-hospital patient transport.⚠️ Warming and infusion of platelet preparations are strictly prohibited.
七、禁忌症 Contraindications
中文
严禁用于血小板、冷沉淀制剂加温输注;
已知对管路高分子材料、环氧乙烷灭菌残留物存在严重过敏;
临床诊疗中禁止快速大容量静脉输液的患者;
严重静脉血管病变,无法耐受持续静脉输注。
English
Warming and infusion of platelets and cryoprecipitate are strictly prohibited;
Known severe allergy to tubing polymer materials or ethylene oxide residuals;
Patients for whom rapid large-volume intravenous infusion is clinically contraindicated;
Severe venous vasculopathy unable to sustain continuous intravenous infusion.
八、注意事项 Precautions
中文
操作人员须熟悉加温仪与配套管路操作流程,全程规范执行无菌操作;
外包装破损、漏气、超过灭菌有效期严禁使用;一次性使用,禁止清洗复用;
仅适配原厂 Buddy 系列加温仪,不得强行装配至其他品牌加温设备;
装入卡匣前确认加热仓内无杂物,仓盖完全闭合后方可启动加热;
使用时保持排气膜朝上,严禁挤压、倒置排气区域,防止排气失效与漏液;
输注流速请勿超过 100mL/min,流速过高会造成液体加温不足;
持续观察穿刺部位,警惕液体外渗引发局部组织刺激;
避免暴力弯折、挤压管路,防止流道堵塞;
血液制品请勿长时间滞留于管路内,遵循临床输血规范。
English
Operators must be familiar with operation procedures of warmer and matched set; standardized sterile technique shall be followed throughout;
Do not use if package damaged, leaking or expired. Single-use only; cleaning and reuse are forbidden;
Only compatible with original Buddy series warmer. Do not force installation into third-party warming equipment;
Confirm no foreign objects inside heating chamber before loading cassette; activate heating only after lid is fully closed;
Keep vent membrane upward during use. Do not compress or invert vent area to avoid vent failure and liquid leakage;
Do not exceed maximum flow rate 100mL/min; excessive flow leads to insufficient fluid warming;
Continuously observe venipuncture site to guard against extravasation and local tissue irritation;
Avoid violent bending or squeezing tubing to prevent channel occlusion;
Do not retain blood products inside tubing for prolonged time; comply with clinical blood transfusion guidelines.

九、存储条件 Storage Conditions
中文储存环境温度:5℃~30℃;相对湿度:30%~75%,环境无凝露;环境要求:干燥通风、无尘;避免阳光直射、挤压、撞击;远离有机溶剂、腐蚀性气体;产品保持原装密封包装,平放或直立存放,禁止冷冻;须在 3 年货架有效期内使用,超过有效期禁止临床使用。
EnglishStorage Temperature: 5℃~30℃;Relative Humidity: 30%~75%, no condensation;Requirements: Dry, ventilated and dust-free; avoid direct sunlight, extrusion and impact; keep away from organic solvents and corrosive gas;Keep products in original sealed package, store horizontally or vertically. Freezing is prohibited;Use within 3-year shelf life. Expired products are forbidden for clinical application.
Shanghai Kangshida Medical Devices Co., Ltd. is a professional company engaged in the sales of medical devices, focusing on the agency and distribution of renowned medical equipment brands from both domestic and international markets. Its core product range covers full-scenario medical devices for physical examination, diagnosis, emergency treatment, laboratory testing, ultrasound, medical analysis, life sciences, disinfection and sterilization, rehabilitation therapy, operating rooms, emergency rooms, consulting rooms and other fields. Relying on its strong product sales capacity, excellent commercial reputation and integrity-based operation philosophy, the company has won unanimous recognition and trust from medical institutions and partners.
The steady and rapid development of the company is attributed to its carefully selected high-quality product portfolio. It always takes customer needs as the core orientation and is committed to creating long-term value and practical benefits for customers. As an authorized and exclusive agent for many well-known domestic and international manufacturers, the company has established a complete supply system of medical devices with reliable quality, fully meeting the needs of clinical diagnosis and treatment.
The company always takes improving customer satisfaction as its core goal. To strictly adhere to product standards and exceed the expectations of customers and manufacturers, it regularly provides training on professional ethics and professional business skills, forging a highly competent, efficient and executive team covering business, technology and management. The team implements a 7×24-hour all-weather response mechanism to provide professional and high-quality after-sales service and technical support, efficiently solving various equipment operation and maintenance problems. At the same time, the company offers exclusive services including same-day delivery and free distribution, forming a closed loop covering supply, distribution and after-sales service to fully ensure the stable supply and worry-free use of medical equipment for medical institutions.
Upholding integrity as the foundation of its business, the company selects high-quality medical devices and provides professional services for customers, helping to upgrade the quality of medical services and contributing to the high-quality development of China's medical industry.
Intellectual Property Infringement Complaint: Kangshida Medical does not manufacture medical products; all products are sourced from original manufacturers. We will promptly address any intellectual property infringement issues.The content published herein is for reference only.
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