厂家直供费森尤斯肠内营养泵Amika CN
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厂家直供费森尤斯肠内营养泵Amika CN
桂经理19117326863微xin同号
管理类别
第二类
型号规格
Amika CN
结构及组成/主要组成成分
本品包括泵座、泵体和外接电源三部分。
适用范围/预期用途
与肠内营养输注管路配合使用，用于患者连续或间断进行肠内管饲喂养。
一、工作原理（Working Principle）
中文
线性蠕动泵驱动（核心）
内置 线性蠕动指状结构，通过电机驱动 顺序挤压、放松 专用营养管路（管外挤压、血液 / 营养液非接触），形成 连续、匀速、脉冲小 的正压推送，将营养液输送至胃肠道。
智能传感与闭环控制
集成 流量传感器、压力传感器、气泡传感器、门控传感器，实时监测输注状态；MCU 闭环调节转速，确保 流量精度 ±5%。
防自由流安全机制
泵门内置 机械夹管结构，开门自动夹闭管路、停泵；配套管路带 Amika 防自由流夹，双重防止重力自流、误输注。
堵塞识别与报警
监测管路压力变化，堵塞时自动反轴（回抽） 疏通，同时声光报警，降低堵管风险。
English
Linear Peristaltic Drive (Core)
Built-in linear peristaltic fingers; motor-driven sequential compression & relaxation of dedicated feeding tubing (external compression, no contact with ｆormula). Delivers smooth, consistent, low-pulse positive-pressure infusion.
Smart Sensor & Closed-Loop Control
Integrated flow, pressure, air-in-line, door sensors; real-time monitoring. MCU closed-loop adjusts speed for ±5% flow accuracy.
Free-Flow Protection
Mechanical clamp in door: auto-clamps tubing when door opens/stops. Sets include Amika anti-free-flow clamp; dual gravity-freeflow prevention.
Occlusion Detection & Alarm
Monitors line pressure; auto-reverse (retract) to clear occlusions + audible/visual alarm; reduces clog risk.
二、核心功能（Core Functions）
表格
中文功能 English Function
输注控制：1–600mL/h 连续可调，总量 1–5000mL，精度 ±5% Precision Infusion: 1–600mL/h adjustable; 1–5000mL dose; ±5% accuracy
双模式输注：连续模式（Continuous）、间歇模式（Intermittent） Dual Modes: Continuous, Intermittent feeding
自动 / 手动快排：一键排气、快速预冲，缩短准备时间 Auto/Manual Bolus: One-touch purge/prime; fast setup
堵塞自动反轴：堵管自动回抽疏通，减少人工干预 Auto-Reverse on Occlusion: Auto-retract to clear clots; less intervention
多重安全报警：完成、堵塞、气泡、门开、低电、故障、超时 Multi-Alarms: Dose complete, occlusion, air, door open, low battery, fault, timeout
防自由流双重保护：机械夹管 + 专用管路夹，杜绝自流风险 Dual Free-Flow Protection: Mechanical clamp + set clamp; zero gravity flow
超长续航：内置 NiMH 电池，125mL/h 下续航 24h，充电 6h 满 Long Battery Life: NiMH; 24h at 125mL/h; 6h full charge
便携易用：轻量 610g、IP35 防水、可夹床 / 杆（Ø8–40mm） Portable: 610g; IP35; clamp for bed/rail (Ø8–40mm)
按键锁定：防误触，适合家庭 / 患者自主使用 Keypad Lock: Prevents accidental operation; home/patient-safe
三、产品特点（Product Features）
中文
医用级稳定
线性蠕动技术，脉冲小、流速稳，降低腹胀、腹泻、误吸风险。
全量程 ±5% 精度，符合 IEC 60601-2-24 医用标准。
全场景安全设计（核心）
双重防自由流：开门即夹管 + 专用管路防漏夹，100% 防重力自流。
气泡监测 + 堵塞反轴：微气泡即停泵；堵管自动回抽疏通，减少堵管 70%。
声光报警 + 屏幕提示：8 类报警，清晰易识别，符合临床安全规范。
便携与续航兼顾
整机 610g、紧凑 138×128×48mm，单手可持、床旁 / 转运 / 家庭通用。
24h 电池续航（125mL/h），充电 6h 满，脱离电源全天使用。
IP35 防水，防泼溅、易清洁，适配 ICU / 病房 / 家庭环境。
操作极简、人性化
图标化 LCD 屏（160×240），文字 + 图形，多语言、易读、防误操作。
5 键直控：开机、快排、开始 / 停止、加 / 减、模式 / 锁定，1 分钟上手。
静音运行（＜45dB），不扰患者休息。
全适配兼容
适配 Amika 专用营养管路（7751729AP/7751810AP 等），无 DEHP、无乳胶。
可夹 床栏（10–35mm）、输液杆（Ø8–40mm），安装灵活。
权威合规
注册证：国械注进 2022314XXXX（Ⅲ 类医疗器械）
认证：CE、ISO 13485、IEC 60601-1/-2-24
English
Medical-Grade Precision & Stability
Linear peristalsis: low pulse, smooth flow; reduces bloating, diarrhea, aspiration.
±5% accuracy across range; meets IEC 60601-2-24.
Total Safety Design (Core)
Dual free-flow protection: door clamp + set clamp; 100% gravity-flow proof.
Air-in-line + auto-reverse: stops on micro-bubbles; retracts on occlusion; 70% fewer clogs.
Audible/visual alarms + display: 8 alarms; clear, compliant.
Portable & Long-Lasting
610g, compact 138×128×48mm; handheld, bedside/transport/home.
24h battery (125mL/h), 6h charge; cord-free all day.
IP35 waterproof; splash-proof, easy clean (ICU/ward/home).
Ultra-Simple & Ergonomic
Icon LCD (160×240): text+graphics; multilingual, easy-read.
5 direct keys: on, bolus, start/stop, ↑/↓, mode/lock; 1-min setup.
Quiet (<45dB): no patient disturbance.
Universal Compatibility
Fits Amika dedicated sets (7751729AP etc.); DEHP-free, latex-free.
Clamps bed rails (10–35mm) / poles (Ø8–40mm); flexible mounting.
Regulatory Compliance
Reg. No.: 国械注进 2022314XXXX (Class III)
Certifications: CE, ISO 13485, IEC 60601-1/-2-24
四、技术参数（Technical Specifications）
| 参数（中） | Parameter (En) | 规格值 ||---|---|| 型号 | Model | Amika CN || 泵类型 | Pump Type | 线性蠕动式（Linear Peristaltic） || 流量范围 | Flow Rate | 1–600 mL/h（步进 1mL/h） || 输注总量 | Dose Volume | 1–5000 mL（步进 1mL） || 流量精度 | Flow Accuracy | ±5%（125mL/h，标准条件） || 堵塞检测 | Occlusion Detection | ＜6min@50mL/h（水）；自动反轴 || 电池 | Battery | NiMH；24h@125mL/h；充电 6h 满 || 供电 | Power | AC 100–240V（适配器）+ 内置电池 || 显示 | Display | 单色 LCD（160×240）；图标化界面 || 尺寸（泵） | Dimensions (Pump) | 138×128×48 mm || 重量（泵） | Weight (Pump) | 610 g；泵座 350g || 防护等级 | Waterproof | 泵 IP35；泵座 IP32；适配器 IP41 || 安装夹 | Clamp | 床栏（10–35mm）、杆（Ø8–40mm） || 材质 | Materials | ABS/PC；无 DEHP、无乳胶、无热原 || 灭菌 | Sterilization | 泵可重复使用；管路一次性 EO 灭菌 || 使用时限 | Max Use | 泵长期复用；管路 ≤24h 更换 || 工作环境 | Operating | 10–40℃；30–85%RH；700–1060hPa；≤3000m || 存储环境 | Storage | -20–+45℃；20–90%RH；500–1060hPa || 配套管路 | Sets | 7751729AP/7751810AP/7751590AP/7751830AP |
五、使用方法（Usage Instructions）
中文
1. 准备与安装
核对 泵有效期、电池电量、包装完好；安装 泵座 于床栏 / 杆，卡紧固定。
打开泵门，装入 Amika 专用管路，确认管路平整、无扭曲、卡入蠕动槽。
关闭泵门（自动夹管），连接 营养袋 / 瓶 与管路入口。
2. 排气预冲
按 快排键（Bolus），自动 / 手动排气，排尽管路气泡，确认通畅无气。
连接 患者鼻胃管 / 鼻肠管 / 胃造瘘管，确认接头牢固、无漏液。
3. 参数设置
开机 → 选 模式（连续 / 间歇） → 设 流量（mL/h） → 设 总量（mL）。
按需开启 按键锁定，防误触；确认 报警音量、电池状态。
4. 启动输注
按 开始键，泵自动运行；观察流速、无气泡、无漏液、无报警。
每 2–4h 检查：管路通畅、患者耐受、腹部体征、胃残余量。
5. 报警处理
完成：声光提示 → 按 停止 → 夹闭管路 → 更换营养袋。
堵塞：泵自动 反轴疏通；仍堵 → 停泵、检查管路、冲管 / 换管。
气泡：立即 停泵 → 开门排气 → 重启。
门开 / 低电：关门、充电；电池＜10% 及时接电源。
6. 结束与维护
按 停止 → 夹闭管路 → 分离患者端 → 一次性管路废弃。
泵体 75% 酒精擦拭、清洁、充电备用；严禁浸泡、高压灭菌。
English
1. Prep & Installation
Check pump expiry, battery, integrity; mount holder on bed/rail; secure clamp.
Open door; load Amika set—smooth, no kinks, seated in peristaltic track.
Close door (auto-clamp); connect ｆormula bag/bottle to inlet.
2. Priming & Purging
Press Bolus; auto/manual purge air; confirm clear, no bubbles.
Connect to patient NG/NJ/PEG tube; secure, no leaks.
3. Program Settings
Power on → select mode (continuous/intermittent) → set rate (mL/h) → set dose (mL).
Enable keypad lock (optional); confirm alarm volume, battery.
4. Start Infusion
Press Start; run automatically; monitor flow, no air/leaks/alarms.
Q2–4h checks: patency, patient tolerance, abdomen, gastric residual.
5. Alarm Response
Dose complete: alarm → Stop → clamp → replace ｆormula.
Occlusion: auto-reverse; if persistent → stop, check, flush/change set.
Air-in-line: immediate stop → open door, purge → restart.
Door open/low battery: close door, charge; <10% battery connect AC.
6. Termination & Care
Press Stop → clamp → disconnect patient → discard set.
Wipe pump with 75% alcohol; clean, charge; no immersion/ autoclaving.
六、适应症（Indications）
中文
适用于需肠内管饲营养 / 水化的成人、儿童、新生儿：
吞咽障碍：脑卒中、脑外伤、帕金森、痴呆、头颈部肿瘤、肌无力。
胃肠道功能障碍：术后胃瘫、短肠综合征、炎性肠病、胰腺炎（恢复期）。
高代谢 / 营养不足：创伤、烧伤、重症感染、肿瘤放化疗、慢性消耗病。
新生儿 / 儿科：早产儿、低体重、先天性消化道畸形、喂养不耐受。
家庭护理：长期卧床、老年衰弱、植物人、家庭肠内营养支持。
围手术期：术前营养储备、术后早期肠内营养、加速康复（ERAS）。
English
For enteral feeding/hydration in adults, pediatrics, neonates:
Dysphagia: stroke, TBI, Parkinson’s, dementia, head/neck cancer, myasthenia.
GI dysfunction: post-op gastroparesis, short bowel, IBD, pancreatitis (recovery).
Hyperｍmbedbolism/deficiency: trauma, burns, sepsis, oncology, chronic wasting.
Neonatal/pediatric: preterm, low birth weight, congenital GI anomalies, feeding intolerance.
Home care: bedridden, frail elderly, vegetative state, home EN support.
Perioperative: pre-op reserve, early post-op EN, ERAS pathways.
七、禁忌症（Contraindications）
中文
绝对禁忌
完全性肠梗阻、肠道缺血 / 坏死、急性腹膜炎、严重消化道出血。
顽固性呕吐、严重腹泻、高流量肠瘘、腹腔间隔室综合征。
严重凝血障碍、血流动力学不稳定、休克未纠正。
近端胃肠道吻合术后＜72h、吻合口漏风险。
对 泵材质 / 管路材质 严重过敏者。
相对禁忌（慎用）
胃排空严重障碍、胃残余量＞200mL（成人）/＞10mL/kg（儿童）。
中重度腹胀、腹痛、恶心、不耐受匀速输注。
严重水电解质紊乱、肾功能衰竭、肝功能衰竭（代谢不耐受）。
新生儿＜28 周、体重＜1.5kg（需严格监护）。
English
Absolute Contraindications
Complete bowel obstruction, intestinal ischemia/necrosis, acute peritonitis, severe GI bleeding.
Intractable vomiting, severe diarrhea, high-output fistula, abdominal compartment syndrome.
Severe coagulopathy, hemodynamic instability, uncorrected shock.
Proximal GI anastomosis <72h, high leak risk.
Severe allergy to pump/set materials.
Relative Contraindications (Caution)
Severe gastroparesis, gastric residual >200mL (adult)/>10mL/kg (pediatric).
Moderate-severe distension, pain, nausea, intolerance to continuous infusion.
Severe electrolyte imbalance, renal/hepatic failure (ｍmbedbolic intolerance).
Neonate <28w, <1.5kg (strict monitoring required).
八、注意事项（Precautions）
中文
专业使用： 医护 / 经培训家属 操作；严禁非专业调试。
管路专用：仅用 Amika 配套管路，禁用其他管路（防精度 / 安全失效）。
防自由流：开门必夹管、停泵必夹管；双重防漏，严禁重力自流。
排气：输注前 100% 排空气泡，防空气栓塞、胃胀气。
流速规范：从小剂量起始（成人 20–50mL/h、儿童 5–10mL/h），耐受后渐增。
全程监护：每 2–4h 查 管路、耐受、残余量、腹部、水电解质。
堵塞处理：堵管 先反轴、再温水冲管；严禁暴力推注（防管路破裂）。
感染防控：营养袋 / 管路 ≤24h 更换；无菌操作、防污染。
电池管理：长期存放每月充 1 次；使用前确认电量 ≥50%。
儿童 / 新生儿：严格控量控速、专人监护、防拔管、防误触。
English
Qualified Use: Only trained staff/caregivers; no unqualified adjustment.
Dedicated Sets: Amika sets only—others risk accuracy/safety failure.
Free-Flow Prevention: Clamp on door open/pause; dual protection; no gravity feed.
Full Purge: 100% air removal before infusion; prevent embolism/ distension.
Gradual Rate: Start low (adult 20–50mL/h, pediatric 5–10mL/h); titrate to tolerance.
Continuous Monitoring: Q2–4h checks: patency, tolerance, residual, abdomen, electrolytes.
Occlusion Care: auto-reverse → warm water flush; no forceful bolus (risk rupture).
Infection Control: Bags/sets ≤24h change; aseptic technique.
Battery Care: Charge monthly in storage; ≥50% before use.
Pediatric/Neonate: Strict rate/volume, dedicated monitor, prevent extubation/accidental touch.
九、存储条件（Storage Conditions）
中文
泵存储
温度：-20℃～+45℃
湿度：20%–90%RH，无冷凝
环境：干燥、通风、避光、防尘、防腐蚀、防电磁
禁止：冷冻、高温、潮湿、震动、重压、液体浸泡
电池：长期存放 50%–70% 电量，每月补充 1 次
管路存储
温度：15℃–25℃（室温）
有效期：2 年（EO 灭菌），包装完好、无菌、无破损
使用前：室温平衡 30min；检查 泵功能、管路无菌、无破损
English
Pump Storage
Temp: -20°C to +45°C
Humidity: 20–90%RH, non-condensing
Environment: dry, ventilated, dark, dust/corrosion/EMI-proof
Prohibited: freezing, heat, moisture, shock, pressure, immersion
Battery: 50–70% charge in storage; recharge monthly
Set Storage
Temp: 15–25°C (room)
Shelf Life: 2 years (EO sterilized); intact, sterile, undamaged
Pre-Use: Equilibrate 30min at room temp; check pump function, set sterility.
十、说明书核心信息（Manual Key Inｆormation）
中文
产品标识：名称 肠内营养泵（喂养泵）、型号 Amika CN、注册证 国械注进 2022314XXXX、批号、有效期、厂家 Fresenius Kabi。
组成：泵体、泵座、AC 适配器、专用营养管路、说明书。
适用范围：医院 / 家庭 成人、儿童、新生儿 连续 / 间歇肠内管饲营养 / 水化。
安全声明
一次性管路、复用泵；管路 ≤24h 更换、严禁复用。
仅用 Amika 管路；禁用其他管路致精度 / 安全失效。
双重防自由流：开门夹管 + 管路夹，严禁重力输注。
报警必须处理：堵塞 / 气泡 / 完成 / 低电 / 故障，严禁屏蔽报警。
儿童 / 新生儿：专人监护、严格参数、防拔管、防误触。
维护保养：泵体 酒精擦拭、清洁、充电；严禁浸泡 / 灭菌 / 拆卸。
废弃处理：管路按 医疗废物 处置；泵报废按电子废弃物法规。
责任声明：未按说明书操作致 感染、误吸、死亡 等，使用者承担责任。
English
Labeling: Enteral Feeding Pump, Model Amika CN, Reg No. 国械注进 2022314XXXX, Lot, Expiry, Fresenius Kabi.
Components: Pump, holder, AC adaptor, dedicated sets, IFU.
Intended Use: Hospital/home continuous/intermittent enteral feeding/hydration (adult/pediatric/neonate).
Safety Statements
Sets single-use, pump reusable; sets ≤24h change, no reuse.
Amika sets only; others risk accuracy/safety failure.
Dual free-flow protection: door clamp + set clamp; no gravity feed.
All alarms must be addressed: occlusion/air/complete/low battery/fault; no alarm bypass.
Pediatric/neonate: dedicated monitoring, strict settings, prevent extubation/touch.
Maintenance: Wipe with alcohol, clean, charge; no immersion/sterilization/disassembly.
Disposal: Sets as medical waste; pump per e-waste regulations.
Liability: User liable for infection, aspiration, death from improper use.
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.
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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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