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厂家直供百特一次性使用输注装置2C1008K,2C1009K
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厂家直供百特一次性使用输注装置2C1008K,2C1009K
桂经理19117326863微xin同号
产品名称 一次性使用输注装置Infusor LV
管理类别 第三类
型号规格 2C1008K，2C1009K
结构及组成/主要组成成分 一次性使用输注装置由无菌保护帽、旋翼（鲁尔）外圆锥锁定接头保护帽、外壳、线圈帽、应力构件（顶端为单向阀加药口，中下部有突起颗粒）、检查带、药液过滤器、塞子、弹性贮液囊、弹性贮液囊包裹膜、流速限制器、流速限制器外壳、管路、（鲁尔）外圆锥锁定接头、O形环（小号）、O形环（大号）组成，一次性使用，伽马射线灭菌。
适用范围/预期用途 一次性使用输注装置适用于术中缓慢、连续静脉内及皮下或硬膜外给药，或术后痛症处理皮下给药。使用者应严格按照药品说明书配制并输注药物。
产品信息
中文：一次性使用输注装置（弹力输注泵 / 便携式化疗泵）英文：Single-use Infusion Device (Elastomeric Infusor LV)品牌：Baxter 百特注册证：国械注进 20163142264型号：2C1008K（2mL/h）、2C1009K（5mL/h）标称总容量：240mL，最大填充容量 300mL，残余残液≤3mL
一、工作原理 Working Principle
中文
产品以医用硅胶弹力贮液囊自然收缩产生持续稳定内压作为输注动力，药液经管路内置精密限流毛细管恒定控制流速，实现微量匀速持续给药；可选配 PCA 自控给药组件，患者按压按键可单次追加定量药液，限流结构全程锁定流速，不受电源、电子程序干预，依靠纯物理弹力完成全程输注。
English
The device relies on the natural contraction force of medical silicone elastomeric reservoir to generate stable internal pressure for infusion. The liquid passes through built-in precision capillary flow restrictor to control flow rate steadily for continuous micro-infusion. Optional PCA patient-controlled module allows patients to deliver a fixed bolus dose by pressing the button. The flow restrictor locks the flow rate purely by physical elasticity without power supply or electronic programming throughout the whole infusion cycle.
二、产品功能 Functions
中文
持续微量匀速输注：2C1008K 恒定 2mL/h、2C1009K 恒定 5mL/h 给药；
可选患者自控追加给药（PCA）：单次追加 0.5mL，具备锁定间隔防过量给药；
全密闭药液输送，内置药液过滤器拦截微粒杂质；
单向阀加药口，防止药液反流、空气进入管路；
防折延长管路，鲁尔锁定接头适配临床各类输注通路；
可视化容量刻度，直观查看剩余药液，带空液提示标识。
English
Continuous uniｆorm micro-infusion: 2C1008K nominal flow rate 2mL/h, 2C1009K nominal flow rate 5mL/h for long-term medication delivery;
Optional PCA bolus function: 0.5mL per bolus with lock-out interval to prevent over-dosing;
Fully closed fluid delivery system with built-in filter to block particulate impurities;
One-way fill port prevents liquid backflow and air ingress into tubing;
Kink-resistant extension tubing with Luer lock connectors compatible with all clinical access routes;
Visual volume scale for residual liquid observation, with empty reservoir indicator.
三、产品特点 Product Features
中文
便携居家：无电池、无电源线、无需输液架，自重仅 39–61g，轻便小巧，患者可下床活动、带泵出院；
安全稳定：硬质外壳保护弹力囊不受外力挤压，全密闭无乳胶、不含 DEHP 增塑剂；防折管设计避免管路弯折断流；42 种常用药物相容性验证；
操作简便：三步完成灌注、预冲、连接；瓶盖颜色区分流速；泵体平面可粘贴患者信息标签；
舒适静音：全程无机械噪音，不影响患者休息；可简易包裹短时间淋浴；
流速可控：内置固定限流器，无法人为篡改输注速度；输注时长误差 ±10% 以内；
一次性无菌：环氧乙烷灭菌，单人单次使用，杜绝交叉感染风险。
English
Ambulatory & portable: No battery, power cord or IV pole required; net weight only 39–61g, lightweight for ambulatory treatment and home discharge;
Safe & stable: Rigid outer shell protects elastomeric reservoir from external compression; latex-free & DEHP-free fully closed system; kink-resistant tubing; compatibility verified for 42 common clinical medications;
User-friendly: Only 3 steps for filling, priming and connection; color-coded cap for quick flow rate identification; flat surface for patient label attachment;
Quiet & comfortable: Silent operation without mechanical noise, compatible with brief shower with proper packaging protection;
Fixed accurate flow: Built-in non-adjustable restrictor prevents manual tampering; total infusion duration tolerance within ±10%;
Single sterile disposable: EO sterilized for single patient use only to avoid cross-contamination.
四、技术参数 Technical Specifications
| 参数项 | 2C1008K | 2C1009K |
|---|---|---|
| 标称流速 | 2 mL/h | 5 mL/h |
| 标称容量 | 240 mL | 240 mL |
| 最大填充容量 | 300 mL | 300 mL |
| 管路预冲容积 | 约 1.2 mL | 约 1.2 mL |
| 残液量 | ≤3 mL | ≤3 mL |
| 标准控温流速环境 | 限流器 33.3℃（92℉） | 限流器 31.1℃（88℉） |
| 温度流速影响 | 温度每升降 1℃，流速增减约 2.3% | 温度每升降 1℃，流速增减约 2.3% |
| PCA 单次追加剂量 | 0.5 mL | 0.5 mL |
| 自控锁定间隔 | 6min / 15min（配套管路） | 6min / 15min（配套管路） |
| 灭菌方式 | 环氧乙烷（EO） | 环氧乙烷（EO） |
| 储存有效期 | 5 年 | 5 年 |
| 材质 | 硅胶弹力囊、聚丙烯、PE、ABS，无乳胶、无 DEHP | 硅胶弹力囊、聚丙烯、PE、ABS，无乳胶、无 DEHP |
| 流速误差范围 | ±12.5% | ±12.5% |
| 管路长度 | 标准临床延长管 | 标准临床延长管 |
| 适配输注通路 | 静脉、皮下、硬膜外、神经阻滞导管 | 静脉、皮下、硬膜外、神经阻滞导管 |
English
| Item | 2C1008K | 2C1009K |
|---|---|---|
| Nominal Flow Rate | 2 mL/h | 5 mL/h |
| Nominal Reservoir Volume | 240 mL | 240 mL |
| Maximum Fill Volume | 300 mL | 300 mL |
| Tubing Priming Volume | ~1.2 mL | ~1.2 mL |
| Residual Dead Volume | ≤3 mL | ≤3 mL |
| Standard Restrictor Temperature for Rated Flow | 33.3℃ (92℉) | 31.1℃ (88℉) |
| Temperature Impact on Flow | ±2.3% flow change per 1℃ shift | ±2.3% flow change per 1℃ shift |
| PCA Bolus Volume | 0.5 mL per press | 0.5 mL per press |
| PCA Lock-out Interval | 6min / 15min (matching module) | 6min / 15min (matching module) |
| Sterilization | Ethylene Oxide (EO) | Ethylene Oxide (EO) |
| Shelf Life | 5 years | 5 years |
| Materials | Silicone reservoir, PP, PE, ABS; Latex-free, DEHP-free | Silicone reservoir, PP, PE, ABS; Latex-free, DEHP-free |
| Flow Rate Tolerance | ±12.5% | ±12.5% |
| Compatible Access Routes | IV, subcutaneous, epidural, peripheral nerve block catheter | IV, subcutaneous, epidural, peripheral nerve block catheter |
五、使用方法 Operation Instructions
中文
术前检查：拆开无菌包装，核查型号、灭菌标识、有效期；检查泵体、管路无破损、漏液、弯折；
药液配制：按医嘱稀释药物至适配浓度，注射器抽取药液，排空注射器内全部空气，严禁带针头操作加药口；
填充药液：旋开加药口保护帽，注射器鲁尔端锁紧加药口，匀速下压推杆将药液注入弹力囊，注满后旋紧保护帽；
管路预冲：打开管路滑块夹，自然释放药液排空管路内全部空气，确认液体顺畅流出后关闭滑块夹；
通路连接：去除远端鲁尔保护帽，连接患者静脉 / 皮下 / 硬膜外留置导管，锁紧鲁尔接头防脱落；
启动输注：打开滑块夹，悬挂泵体（低压环境必须悬挂），观察刻度确认药液正常流出；
PCA 自控给药：医生指导下，患者疼痛加剧时按压自控按钮，按设定间隔自动锁定，不可连续追加；
结束处置：药液输注完毕后，断开管路，整套装置一次性丢弃，不可重复使用。
English
Pre-use Inspection: Open sterile pouch, verify model, sterilization mark and expiry date; check pump body and tubing for crack, leakage or kink;
Medication Preparation: Dilute drug to prescribed concentration as physician order; draw solution into syringe and fully evacuate air; do not attach needle to syringe to avoid fill port damage;
Reservoir Filling: Unscrew fill port cap, lock syringe Luer tip onto fill port, inject liquid steadily into elastomeric reservoir, retighten cap after filling;
Tubing Priming: Open slide clamp, allow liquid to purge all air inside tubing; close clamp after steady liquid outflow is confirmed;
Patient Connection: Remove distal Luer cap, connect to patient IV / subcutaneous / epidural catheter, lock Luer connector to prevent disconnection;
Start Infusion: Open slide clamp, hang pump vertically (mandatory at low altitude); observe liquid flow via volume scale;
PCA Bolus Use: Under medical guidance, patient may press PCA button for breakthrough pain; bolus locked per preset interval to avoid repeated dosing;
Disposal After Use: Disconnect tubing upon completion of infusion; discard entire device as single-use waste, reuse is prohibited.
六、适应症 Indications
中文
适用于临床持续性微量药液输注治疗，给药通路包含静脉、皮下、硬膜外、术中局部创面给药：
术后持续性镇痛（硬膜外 / 皮下神经阻滞止痛）；
术中持续缓慢静脉、硬膜外给药；
肿瘤化疗持续微量给药；
慢性疼痛、姑息治疗镇痛；
抗生素、抗病毒长期微量输注（骨髓炎、囊性纤维化等）；
门诊、居家便携持续输液治疗。
English
For clinical continuous micro-infusion via intravenous, subcutaneous, epidural or intraoperative wound routes:
Continuous post-operative pain management (epidural / peripheral nerve block analgesia);
Slow continuous intraoperative IV & epidural medication delivery;
Long-term low-rate chemotherapy infusion for oncology patients;
Chronic pain & palliative care analgesia;
Long-term antibiotic / antiviral infusion (osteomyelitis, cystic fibrosis, etc.);
Ambulatory outpatient & home continuous infusion therapy.
七、禁忌症 Contraindications
中文
对产品硅胶、聚丙烯、管路高分子材料或输注药物严重过敏者禁用；
给药通路存在感染、局部皮肤破溃、脓肿、静脉炎急性期，禁止皮下 / 硬膜外输注；
严重凝血功能障碍、穿刺部位活动性出血未控制者；
药液理化性质与泵体材料不相容，易析出、降解、腐蚀管路时禁止使用；
患者无法配合、存在意识障碍、无法识别 PCA 自控给药风险者，不建议使用 PCA 组件；
需快速大剂量冲击给药、不适用微量匀速输注的治疗场景。
English
Contraindicated for patients with severe allergy to silicone, polypropylene, tubing polymer materials or infused medication;
Subcutaneous / epidural infusion forbidden if access site has active infection, skin ulceration, abscess or acute phlebitis;
Uncontrolled active bleeding at puncture site or severe coagulation disorders;
Prohibited if medication has incompatibility with pump materials (precipitation, degradation, tubing corrosion);
PCA module not recommended for confused, unconscious patients unable to understand bolus risks;
Not applicable for high-dose rapid bolus therapy requiring non-continuous micro-rate delivery.
八、注意事项 Precautions
中文
本品环氧乙烷灭菌，仅一次性单人使用，严禁重复灌装、重复使用；
流速受温度、悬挂高度、药液粘度影响：温度每变化 1℃流速波动 2.3%；泵体低于穿刺部位每 2.54cm 流速下降 0.5%；高粘度药液流速偏慢；
全程避免管路挤压、弯折、受压，防止堵管断流；硬质外壳不可拆卸；
加药禁止使用针头，会破坏单向阀密封，造成漏液、进气；
仅使用经相容性验证的药液，不明药物需提前做配伍测试；
患者活动避免泵体剧烈撞击，淋浴需密封包裹泵体，不可长时间浸泡；
儿童、意识不清患者需家属全程监护 PCA 给药，防止误按过量；
输注期间观察穿刺部位有无红肿、渗液、疼痛，出现异常立即关闭滑块夹并通知医护；
不可加热、冷冻泵体，远离高温热源（电热毯、暖风机）；
若出现流速异常、管路漏液、弹力囊破损，立即停止输注更换整套装置。
English
EO sterile single-use device for one patient only; refilling and reuse are strictly forbidden;
Flow rate varies with temperature, pump height and liquid viscosity: ±2.3% flow shift per 1℃ temperature change; 0.5% flow reduction per 2.54cm pump height below access site; higher viscosity liquids slow delivery;
Prevent tubing compression, kinking or pressure to avoid occlusion; rigid outer shell cannot be disassembled;
Needles are prohibited during filling to avoid damaging one-way valve seal, causing leakage or air entry;
Only use medications with verified material compatibility; compatibility test required for unknown drugs;
Avoid violent impact during patient mobility; seal pump fully before brief shower, no prolonged soaking;
Pediatric or confused patients require full caregiver supervision to prevent accidental excessive PCA bolus;
Monitor access site for redness, leakage or pain during infusion; close slide clamp and notify clinician immediately if adverse signs occur;
Do not heat or freeze pump; keep away from high-temperature heat sources (heating pads, blowers);
Stop infusion and replace full unit if abnormal flow, tubing leakage or reservoir rupture occurs.
九、存储条件 Storage Conditions
中文
储存环境：干燥、清洁、避光、常温室内环境；
温湿度区间：温度 0℃～25℃，相对湿度 5%～95%，无凝露；
远离高温、阳光直射、腐蚀性气体、尖锐物品；
不可堆叠重压，防止外包装与泵体变形；
货架有效期 5 年，未开封完好包装在规定条件下储存；
禁止冷冻、冷藏存放，不可置于空调出风口、暖气旁。
English
Storage environment: Dry, clean, room-temperature indoor space away from direct light;
Temperature & humidity range: 0℃ ~ 25℃, relative humidity 5% ~ 95% non-condensing;
Keep away from high temperature, direct sunlight, corrosive gas and sharp ｏbjects;
Do not stack heavy loads to prevent packaging & pump deｆormation;
Shelf life 5 years under specified storage conditions for intact unopened pouches;
Freezing & refrigeration prohibited; avoid placement near air vents or heating equipment.
十、说明书核心总结 Summary
中文
2C1008K（2mL/h）、2C1009K（5mL/h）为百特无电源弹力式一次性输注装置，依靠硅胶囊物理收缩实现恒定微量输注，支持术后镇痛、化疗、抗感染、居家便携输液；全密闭无乳胶 DEHP 设计，操作简易、静音便携，流速由内置限流毛细管固定不可人为调节；使用需严格控制温度、悬挂高度避免流速偏差，单人单次无菌使用，储存避光常温干燥，适配静脉、皮下、硬膜外多通路微量持续给药。
English
Model 2C1008K (2mL/h) and 2C1009K (5mL/h) are Baxter power-free single-use elastomeric infusors. Constant long-term micro-infusion is achieved via physical contraction of silicone reservoir, indicated for post-op analgesia, chemotherapy, anti-infection and ambulatory home infusion. Fully closed latex-free & DEHP-free construction, simple silent portable operation; flow rate locked by built-in capillary restrictor without manual adjustment. Temperature and pump height must be controlled to minimize flow deviation. Single-patient sterile disposable only, stored under cool dry dark environment, compatible with IV, subcutaneous and epidural continuous micro-delivery routes.
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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