厂商直供美德乐负压吸引器Basic,Dominant Flex
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厂商直供美德乐负压吸引器Basic,Dominant Flex
桂经理19117326863微xin同号
桂经理19117326863微xin同号
管理类别
第二类
型号规格
Basic、Dominant Flex
结构及组成/主要组成成分
该产品由主机(便携式、机架式)、引流管、引流瓶、电源线组成。产品各部件型号、规格详见产品技术要求附录B。
适用范围/预期用途
该产品适用于外科手术中液体、组织（包括骨）、呕吐物的吸引。用于手术室或病房。
产品储存条件及有效期
1、工作原理 Working Principle
中文：设备采用活塞‑气缸驱动技术，由微控制器控制电机转速，泵体运转产生稳定负压；通过负压调节阀调节真空度，经管路、储液瓶实现手术体液、组织、气体的抽吸；集成溢流保护、滤菌防护结构，防止液体反流损坏主机，维持持续平稳负压输出FDA Access...。English：Adopts piston‑cylinder driving technology, the microcontroller controls motor speed. The pump generates stable negative pressure; vacuum level is adjusted by vacuum regulator. Suction of surgical fluids, tissues and gas is realized via tubing and collection jar. Integrated overflow protection and bacterial filter prevent fluid backflow and protect unit, maintaining consistent steady vacuum outputFDA Access...。
2、产品功能 Functions
中文1）产生连续可调负压，实现外科手术体液、组织、气体、分泌物抽吸； 2）Basic：固定 30L/min 自由气流；Dominant Flex：40/50/60L/min 三档流量可选； 3）负压实时压力表显示，溢流保护、细菌病毒过滤； 4）可适配多种一次性 / 可重复使用吸引附件； 5）便携 / 机架两种安装形态，可配移动推车； 6）设备状态指示灯提示工作、故障、溢流报警Medela。
English1）Generate continuously adjustable negative pressure for aspiration of surgical fluids, tissues, gas and secretions; 2）Basic: fixed free airflow 30L/min; Dominant Flex: three selectable flow rates 40/50/60L/min; 3）Real‑time vacuum gauge display, overflow protection, bacterial‑virus filtration; 4）Compatible with various disposable/reusable suction accessories; 5）Portable / rack‑mount two configurations, compatible with mobile trolley; 6）Status indicator lights for operation, fault and overflow alarmMedela。
3、产品特点 Product Features
中文1）瑞士原装制造，负压输出稳定无波动； 2）低噪音低振动设计，Dominant Flex 噪声≤40dB (A)； 3）Dominant Flex 支持多档位流量切换，适配不同手术场景；Basic 结构简洁、固定流量，性价比高； 4）表面光滑易清洁消毒，配套丰富耗材； 5）独立负压源，不依赖医院中心负压系统，避免管路交叉污染； 6）完善安全防护：防溢流、滤菌防反流，保护设备与医患安全； 7）5 年主机质保，医用电气安全符合 IEC60601‑1 标准Medela。
English1）Swiss original manufacture, stable non‑fluctuating vacuum output; 2）Low‑noise & low‑vibration design, Dominant Flex noise ≤40dB(A); 3）Dominant Flex supports multi‑level flow switching for diverse surgical scenarios; Basic features simple structure with fixed flow for cost‑effective perｆormance; 4）Smooth surface for easy cleaning & disinfection, wide range of compatible consumables; 5）Independent vacuum source, no reliance on hospital central vacuum system, avoid cross‑contamination; 6）Comprehensive safety protections: overflow prevention, bacterial filter & anti‑reflux to protect equipment, patient and operator; 7）5‑year main unit warranty, compliant with IEC60601‑1 medical electrical safety standardMedela。
4、技术参数 Technical Parameters
中文
表格
| 项目 | Basic | Dominant Flex |
|---|---|---|
| 最大负压 | ‑90kPa（±15%） | ‑95kPa（±15%） |
| 自由气流 | ≥30L/min | ≥40/50/60L/min 三档可选 |
| 驱动方式 | 活塞‑气缸系统 | 活塞‑气缸系统 |
| 功率 | 110‑120W | 120W |
| 噪声 | ≤42dB(A) | ≤40dB(A) |
| 外形尺寸（机架版） | 305×210×375mm | 305×210×375mm |
| 外形尺寸（便携版） | 305×285×375mm | 305×285×375mm |
| 重量 | 机架 9.3kg；便携 9.5kg | 机架 9.3kg；便携 9.5kg |
| 供电 | 100‑240V AC，50/60Hz | 100‑240V AC，50/60Hz |
| 防护等级 | Ⅰ 类电气设备 | Ⅰ 类电气设备 |
English
表格
| Item | Basic | Dominant Flex |
|---|---|---|
| Max Vacuum | ‑90kPa（±15%） | ‑95kPa（±15%） |
| Free Airflow | ≥30L/min | Three selectable levels ≥40/50/60L/min |
| Drive Type | Piston‑cylinder system | Piston‑cylinder system |
| Power | 110‑120W | 120W |
| Noise | ≤42dB(A) | ≤40dB(A) |
| Dimension(Rack) | 305×210×375mm | 305×210×375mm |
| Dimension(Portable) | 305×285×375mm | 305×285×375mm |
| Weight | Rack 9.3kg；Portable9.5kg | Rack 9.3kg；Portable9.5kg |
| Power Supply | 100‑240V AC，50/60Hz | 100‑240V AC，50/60Hz |
| Protection Class | Class I electrical device | Class I electrical device |
5、使用方法 Operating Method
中文1）将设备放置平稳，连接电源线，确认电源供电正常； 2）组装储液瓶、溢流保护组件、滤菌过滤器、吸引管路； 3）连接吸引头，检查管路连接无泄漏； 4）开机，Dominant Flex 按需选择流量档位；旋转负压调节旋钮，观察压力表，设置临床所需负压； 5）实施临床抽吸操作；当储液瓶液位接近上限，溢流保护触发，停止抽吸，及时更换处理储液瓶 / 废液袋； 6）使用完毕，关闭电源，断开管路；接触废液部件按规范清洗、消毒、灭菌或一次性丢弃； 7）定期设备维护校验，由受过培训的医护人员操作本设备Agência Na...。
English1）Place device horizontally, connect power cord and confirm normal power supply; 2）Assemble collection jar, overflow protection set, bacterial filter and suction tubing; 3）Connect suction tip and check all connections for leakage; 4）Power‑on; select flow level for Dominant Flex as required; rotate vacuum regulator knob, observe vacuum gauge and set clinical vacuum value; 5）Perｆorm clinical aspiration. When liquid level approaches maximum, overflow protection activates; stop suction and replace collection jar / waste bag promptly; 6）After use, power off and disconnect tubing. Components contacting body fluids shall be cleaned, disinfected, sterilized or disposed as single‑use per protocol; 7）Routine maintenance and calibration shall be perｆormed; device shall only be operated by properly‑trained clinical staffAgência Na...。
6、适应症 Indications
中文：用于医院、诊所、手术中心，外科手术中抽吸去除手术液体、组织（含骨组织）、体液、分泌物、气体、感染性物质；适用普外科、整形外科吸脂、内镜手术、神经外科、鼻咽吸引、非体外循环冠脉搭桥、心外膜消融、负压辅助分娩、伤口引流等场景。English：For use in hospitals, clinics and surgical centers, to aspirate and remove surgical fluids, tissues (including bone), body fluids, secretions, gas and infectious materials during surgical procedures. Applicable for general surgery, liposuction, endoscopy, neurosurgery, nasopharyngeal suction, OPCAB surgery, epicardial ablation, vacuum‑assisted delivery and wound drainage。
7、禁忌症 Contraindications
中文1）不可用于对动脉、动脉瘤组织直接施加负压抽吸（尤其心外膜消融操作）； 2）禁止用于颅内高压不允许负压吸引的患者； 3）禁止用于眼睛、眼球内部组织直接负压吸引； 4）不可用于未培训人员操作； 5）不可用于可燃、易爆气体环境下使用； 6）不可用于人体气道高压长时间负压抽吸，避免黏膜损伤。
English1）Do not apply direct suction onto arteries or aneurysm tissue (especially during epicardial ablation); 2）Not for patients with intracranial hypertension where suction is contraindicated; 3）Direct negative‑pressure suction on eye / intra‑ocular tissue is prohibited; 4）Operation by untrained personnel is forbidden; 5）Do not operate in flammable or explosive gas atmosphere; 6）Avoid prolonged high‑negative‑pressure suction on human airway to prevent mucosal injury。
8、注意事项 Precautions
中文1）仅可由经过专业培训医护人员操作；每年复训； 2）严格设置临床安全负压，过高负压会造成组织、黏膜损伤； 3）每次使用前检查溢流保护、滤菌过滤器完好；过滤器受潮堵塞需立即更换； 4）储液瓶不可超过最大液位，防止废液倒灌损坏主机； 5）接触体液部件每次使用后清洗消毒；一次性耗材严禁重复使用； 6）设备不得冲洗浸泡；外壳仅可擦拭消毒； 7）设备故障、报警时，停止使用，联系厂家维修，禁止自行拆机； 8）注意电磁兼容，远离强电磁设备； 9）海拔高度会影响最大负压输出，高海拔需评估负压是否满足临床； 10）定期维护，按手册进行校验保养；主机 5 年质保，耗材不在质保范围Medela Hea...。
English1）Only operated by professionally‑trained clinical personnel; annual refresher training required; 2）Set clinically safe vacuum level; excessive negative pressure may cause tissue / mucosal injury; 3）Check integrity of overflow protection and bacterial filter before every use; replace damp or clogged filter immediately; 4）Do not exceed maximum liquid volume of collection jar to prevent waste‑liquid backflow damaging main unit; 5）Clean and disinfect fluid‑contact components after each use; do not reuse single‑use consumables; 6）Do not rinse or immerse the device; only wipe‑disinfect housing surface; 7）Stop operation when fault / alarm occurs; contact manufacturer service; do not disassemble unit by yourself; 8）Observe EMC requirements; keep away from strong electromagnetic equipment; 9）Altitude affects maximum vacuum output; evaluate clinical perｆormance under high‑altitude condition; 10）Perｆorm periodic maintenance and calibration per manual; 5‑year warranty for main unit; consumables excluded from warrantyMedela Hea...。
9、存储条件 Storage Conditions
中文储存环境温度：‑20℃～+70℃； 运输储存相对湿度：10%‑90%，无冷凝； 大气压力：500‑1060hPa； 存放于干燥通风室内，避免阳光直射、粉尘、腐蚀性气体； 闲置时管路清空废液，清洁后存放；耗材按包装要求储存。
EnglishStorage temperature:‑20℃～+70℃; Relative humidity for storage & transport:10%‑90% non‑condensing; Atmospheric pressure:500‑1060hPa; Store in dry & ventilated indoor space, avoid direct sunlight, dust and corrosive gas; Empty residual liquid from tubing before storage; clean before storage; store consumables in accordance with package instructions。
10、说明书核心摘要 Core Summary of IFU
中文：美德乐 Basic/Dominant Flex 为医用电动活塞式负压吸引泵，Basic 固定 30L/min 流量；Dominant Flex 三档流量可调，用于医院手术室、病房外科体液、组织、分泌物抽吸。必须由培训合格人员操作；严格控制负压，防止组织损伤；依靠溢流保护 + 滤菌组件防废液反流；设备主机不可水洗浸泡，接触体液部件按规范处理；高海拔会降低负压性能；定期维护保养；禁止在易燃易爆环境使用；耗材一次性件禁止复用。English：Medela Basic / Dominant Flex are medical electric piston‑driven suction pumps. Basic delivers fixed 30L/min airflow; Dominant Flex provides three adjustable flow rates. Intended for aspiration of surgical fluids, tissues and secretions in hospital operating rooms and wards. Device shall only be operated by qualified trained staff. Strictly control vacuum level to avoid tissue injury. Overflow protection plus bacterial filter assembly prevent waste‑liquid backflow. Main unit cannot be rinsed or immersed; fluid‑contact components shall be processed per protocol. Vacuum perｆormance decreases at high altitude. Perｆorm regular maintenance. Do not use in flammable‑explosive atmosphere. Single‑use consumables must not be reused.
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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