厂商莱博瑞尿动力学导管CAT206,TUB500
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厂商莱博瑞尿动力学导管CAT206,TUB500
桂经理19117326863微xin同号
型号规格 CAT206、CAT208、CAT307、CAT411、CAT506、TUB101、TUB500
结构及组成/主要组成成分 本产品是由CAT导管和TUB导管连接后组成的尿动力学导管。其中，CAT导管由PEBAX（嵌段聚醚酰胺）材料制成，TUB导管由PVC材料制成。CAT导管和TUB导管都不含DEHP和BPA等增塑剂。灭菌方式：环氧乙烷灭菌。使用方式：一次性使用。
适用范围/预期用途 本尿动力学导管是与尿动力学设备相连后对患者进行膀胱内压、尿道内压和直肠压力进行测量。
一、工作原理（Working Principle）
中文
采用水灌注式压力传导+多腔独立通道设计，配合尿动力学主机实现腔内压力测量与膀胱灌注：
压力传导：导管测压腔与主机灌注泵/传感器连通，无菌生理盐水以恒定流速灌注，将膀胱/尿道/直肠腔内压力通过液体传导至主机高精度压力传感器，转换为电信号并实时显示压力曲线。
多腔独立：单/双/三腔设计，测压腔、灌注腔、引流腔物理隔离，避免液体干扰压力信号，支持同步测压+灌注/引流。
信号采集：主机将压力信号放大、模数转换后，计算逼尿肌压（Pdet = Pves - Pabd），生成CMG、UPP、压力-流率等检查数据。
定位辅助：管身1cm刻度+ X光显影标记，判断导管位置，确保测压点准确。
二、产品特点（Product Features）
中文
材质安全：CAT系列为医用PEBAX（嵌段聚醚酰胺），TUB系列为医用PVC；不含DEHP/BPA，生物相容性好，柔软抗折，减少黏膜刺激。
多型号覆盖：单/双/三腔、直型/弯头、腹压/膀胱/尿道专用，适配全场景尿动力学检查。
测压：多腔独立，无交叉干扰；压力传导线性度高，响应快，数据稳定。
可视化定位：管身1cm连续刻度+ X光显影标记，术中定位，减少操作误差。
接头标识：彩色编码接头，快速识别测压/灌注/引流通道，避免接错。
无菌便捷：环氧乙烷灭菌，一次性使用，杜绝交叉感染；即开即用，无需预处理。
兼容广泛：适配Laborie AQS1001/2001/3002/3003/2004等全系列尿动力学主机。
患者舒适：细管径（6–8Fr）、软头设计，插入阻力小，耐受度高。
English
Safe Material: CAT: medical-grade PEBAX; TUB: medical-grade PVC; DEHP/BPA-free, excellent biocompatibility, soft & kink-resistant, minimal mucosal irritation.
Full Model Coverage: Single/dual/triple lumen, straight/coudé tip, abdominal/bladder/urethral specific; fits all urodynamic scenarios.
Precise Measurement: Isolated lumens, no cross-interference; high linearity, fast response, stable data.
Visual Positioning: 1cm continuous scale + radiopaque markers; precise intra-procedural placement, reduced error.
Color-Coded Connectors: Quick identification of pressure/infusion/drainage channels; prevents misconnection.
Sterile & Convenient: EO sterilized, single-use; eliminates cross-infection; ready-to-use, no pre-treatment.
Wide Compatibility: Works with all Laborie AQS series urodynamic systems.
Patient Comfort: 6–8Fr thin gauge, soft tip; low insertion resistance, high tolerance.
三、技术参数（Technical Specifications）
通用参数（Common）
项目（Item）中文（Chinese）英文（English）
材质CAT：PEBAX；TUB：PVC（均无DEHP/BPA）CAT: PEBAX; TUB: PVC (DEHP/BPA-free)
灭菌方式环氧乙烷（EO）灭菌Ethylene Oxide (EO) Sterilization
使用方式一次性使用Single-Use Disposable
管径6Fr（2.0mm）、7Fr（2.33mm）、8Fr（2.67mm）6Fr (2.0mm), 7Fr (2.33mm), 8Fr (2.67mm)
长度膀胱/尿道：30–40cm；腹压：15–20cmBladder/Urethral: 30–40cm; Abdominal: 15–20cm
刻度1cm连续刻度（0–25cm）1cm Continuous Scale (0–25cm)
显影全段X光显影标记Full-Length Radiopaque Markers
接头彩色编码Luer锁定接头Color-Coded Luer Lock Connectors
压力范围-50～+300 cmH₂O-50~+300 cmH₂O
灌注速度0.1–80 mL/min（适配主机）0.1–80 mL/min (Host-Compatible)
兼容主机Laborie AQS全系列Laborie AQS Series
型号差异（Model Differences）
表格
型号（Model）中文（Chinese）英文（English）腔数/类型核心用途（Key Use）
CAT2066Fr单腔膀胱测压导管6Fr Single Lumen Bladder Catheter单腔（测压）膀胱压（Pves）测量
CAT2088Fr双腔膀胱灌注测压导管8Fr Dual Lumen Bladder Catheter双腔（测压+灌注）膀胱测压+生理盐水灌注
CAT3077Fr三腔尿道膀胱导管7Fr Triple Lumen Urethro-Bladder Catheter三腔（测压+灌注+引流）同步测压+灌注+尿液引流
CAT4117Fr弯头膀胱导管（男性专用）7Fr Coudé Tip Bladder Catheter (Male)双腔男性尿道狭窄/ BPH膀胱测压
CAT5066Fr单腔腹压导管（直肠/阴道）6Fr Single Lumen Abdominal Catheter单腔直肠/阴道腹压（Pabd）测量
TUB101连接管（短）Short Connecting Tubing单腔导管-主机短距离连接
TUB500连接管（长）Long Connecting Tubing单腔导管-主机长距离连接
四、使用方法（Operation Instructions）
中文
术前准备：核对型号/灭菌有效期；患者签署知情同意；清洁会阴/肛周；取截石位/左侧卧位。
导管连接：打开包装，将CAT导管与TUB连接管对接，再连接至主机测压/灌注接口；排气泡，确保管路通畅。
插入操作
膀胱导管（CAT206/208/307/411）：润滑后经尿道插入膀胱，见尿后再进2cm；固定导管，气囊充气（≤20 cmH₂O）固定。
腹压导管（CAT506）：润滑后经直肠/阴道插入5–8cm，固定导管。
检查执行：启动主机，选择检查项目（CMG/UPP/压力-流率）；设置灌注速度（≤50 mL/min）；实时监测压力曲线，记录数据。
术后处理：检查结束，放空气囊；轻柔拔出导管；TUB连接管按医疗废物处理；清洁主机接口。
English
Prep: Verify model/sterility expiry; obtain consent; clean perineum/anal area; lithotomy/left lateral position.
Connection: Open package; connect CAT catheter to TUB tubing, then to host pressure/infusion port; purge air bubbles, ensure patency.
Insertion
Bladder Catheters (CAT206/208/307/411): Lubricate→insert urethrally into bladder; advance 2cm after urine return; secure catheter, inflate balloon (≤20 cmH₂O).
Abdominal Catheter (CAT506): Lubricate→insert 5–8cm rectally/vaginally; secure catheter.
Testing: Start host, select protocol (CMG/UPP/Pressure-Flow); set infusion rate (≤50 mL/min); monitor real-time curves, record data.
Post-Procedure: Deflate balloon; gently withdraw; dispose TUB tubing as biohazard; clean host ports.
五、适应症（Indications）
中文
膀胱功能评估：尿频、尿急、尿失禁、排尿困难、尿潴留、神经源性膀胱、膀胱过度活动症（OAB）。
腹压监测：CMG /压力-流率检查中同步测量腹压（Pabd），计算逼尿肌压（Pdet）。
尿道功能评估：尿道压力分布（UPP）、漏尿点压（LPP）、逼尿肌-括约肌协同失调（DSD）。
灌注/引流：膀胱生理盐水灌注（CMG）、尿液引流（压力-流率检查）。
特殊人群：男性尿道狭窄/ BPH（CAT411弯头）、女性盆底功能障碍（CAT506阴道测压）。
术前术后评估：尿失禁/前列腺/膀胱手术前后动力监测、疗效评估。
English
Bladder Function: Frequency, urgency, incontinence, dysuria, retention, neurogenic bladder, overactive bladder (OAB).
Abdominal Pressure: Sync Pabd measurement in CMG/Pressure-Flow; calculate Pdet.
Urethral Function: Urethral pressure profile (UPP), leak point pressure (LPP), detrusor-sphincter dyssynergia (DSD).
Infusion/Drainage: Bladder saline infusion (CMG), urine drainage (Pressure-Flow).
Special Populations: Male urethral stricture/BPH (CAT411 coudé), female pelvic floor dysfunction (CAT506 vaginal).
Pre/Post-Op: Motility monitoring & efficacy evaluation for incontinence/prostate/bladder surgery.
六、禁忌症（Contraindications）
中文
绝对禁忌：急性尿路感染（发热/尿痛）、尿道/膀胱/直肠急性损伤、严重凝血障碍、肛周脓肿/肛裂（CAT506）、无法配合患者。
相对禁忌：妊娠晚期（>36周）、尿道严重狭窄（CAT206/208/307）、近期尿道/膀胱手术（<4周）、抗凝治疗中（高出血风险）。
耗材禁忌：包装破损/过期、非Laborie原厂导管/连接管、重复使用（交叉感染）。
English
Absolute: Acute UTI (fever/dysuria), acute urethral/bladder/rectal injury, severe coagulopathy, perianal abscess/fissure (CAT506), uncooperative patient.
Relative: Late pregnancy (>36w), severe urethral stricture (CAT206/208/307), recent urethral/bladder surgery (<4w), anticoagulation (high bleeding risk).
Consumable: Damaged/expired package, non-Laborie catheters/tubing, reuse (cross-infection).
七、注意事项（Precautions）
中文
无菌操作：严格无菌，一次性使用，严禁重复灭菌/使用；会阴/肛周清洁消毒。
插入轻柔：遇阻力立即停止，避免暴力插入致尿道/直肠黏膜损伤；男性用CAT411弯头通过狭窄。
气囊管理：充气压力≤20 cmH₂O，避免过度充盈致黏膜缺血/疼痛；检查中防止气囊漏气。
管路通畅：连接后充分排气泡，避免气泡干扰压力信号；灌注中保持管路无折压。
灌注控制：灌注速度≤50 mL/min，避免膀胱过度充盈致患者不适/压力伪影。
定位准确：利用刻度与显影标记确认导管位置，测压点需在膀胱/尿道/直肠目标区域。
异常处理：出现血尿/剧痛/感染迹象，立即停止检查并对症处理；压力异常时检查管路与定标。
废物处理：CAT导管与TUB连接管均按感染性医疗废物规范处置。
八、存储条件（Storage Conditions）
中文
未开封：温度15–30℃，湿度≤80% RH，避光、干燥、通风；远离腐蚀性气体/磁场；有效期3年。
已开封：24小时内使用，无菌保存，避免污染；严禁再次灭菌。
禁忌：严禁冷冻、高温（>50℃）、潮湿、直射阳光；避免挤压/穿刺包装。
TUB连接管：同CAT导管存储条件，一次性使用，开封后立即使用。
English
Unopened: 15–30°C,≤80%RH, light-proof, dry, ventilated; away from corrosive gases/magnetic fields; 3-year shelf life.
Opened: Use within 24h; sterile storage, avoid contamination; no re-sterilization.
Prohibited: No freezing, high temp (>50°C), moisture, direct sunlight; avoid package damage.
TUB Tubing: Same storage as CAT; single-use, use immediately after opening.
九、说明书核心信息（Manual Core Inｆormation）
中文
适用范围：与Laborie尿动力学系统配合，测量膀胱压（Pves）、尿道压（Pura）、腹压（Pabd），进行膀胱灌注与尿液引流，辅助下尿路功能障碍诊断。
注册信息：国械注进20182142475；加拿大Laborie生产；第二类医疗器械；有效期至2028-07-24。
结构组成：CAT导管（PEBAX）、TUB连接管（PVC）、Luer锁定接头、X光显影标记、1cm刻度；不含DEHP/BPA。
安全标准：ISO 13485、CE认证、FDA 510 (k)、GB 15810-2019（一次性使用无菌导尿管）。
使用限制：体外诊断、一次性使用；禁止重复灭菌/使用；非治疗用途。
维护要求：主机接口每次使用后清洁消毒；导管/连接管一次性使用，无维护。
故障处理：压力异常→检查管路排气+重新定标；插入困难→换弯头型号（CAT411）；信号丢失→检查连接+更换耗材。
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.
热门标签：厂商莱博瑞尿动力学导管CAT206TUB500,莱博瑞尿动力学导管,莱博瑞尿动力学导管CAT206
