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厂家深度智能尿动力学分析仪HERA UD2S,HERA UD2P
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厂家深度智能尿动力学分析仪HERA UD2S,HERA UD2P
桂经理19117326863微xin同号
产品名称 尿动力学分析仪
管理类别 第二类
型号规格 HERA UD2S、HERA UD2P
结构及组成/主要组成成分 HERAUD2P产品由主控箱、压力采集盒、尿流率计、牵引器、工作站、机架、打印机、尿动力学分析系统软件及选配件(摄像头、刷卡机、遥控器、尿杯、漏斗、漏斗支架、女用坐架、压力盒脱机使用机架)组成。 HERAUD2S产品由主控箱、压力采集盒、尿流率计、牵引器、工作站、机架、打印机、尿动力学分析系统软件及选配件(尿杯、漏斗、漏斗支架、女用坐架)组成。
适用范围/预期用途 本产品通过对尿流率、尿道压、膀胱压、腹压和同步括约肌肌电的定量分析,用于医院或体检中心对下尿路功能的诊断检查。
一、工作原理(Working Principle)
中文设备基于流体力学、电生理学原理与高精度传感技术,结合国际尿控协会(ICS)标准设计。
压力检测:通过膀胱测压导管、腹压(肛门)导管采集膀胱压(Pves)、腹压(Pabd),计算逼尿肌压(Pdet=Pves-Pabd),反映储尿 / 排尿期逼尿肌收缩与尿道阻力变化。
尿流率检测:尿流率计通过重量 / 光电传感实时捕捉尿流速度、流量、时间,生成尿流率曲线。
肌电检测:体表 / 针电极采集尿道括约肌肌电(EMG),评估逼尿肌 - 括约肌协同功能。
智能分析:系统同步采集多通道信号,经算法解析压力 - 流率、压力 - 容积、肌电协同关系,自动生成临床参数与诊断依据。
英文Based on fluid mechanics, electrophysiology, and high-precision sensing, compliant with International Continence Society (ICS) standards.
Pressure Measurement: Bladder (Pves) and abdominal (Pabd) pressures via catheters; detrusor pressure (Pdet=Pves-Pabd) calculated to reflect detrusor contraction and urethral resistance during storage/voiding.
Uroflowmetry: Weight/photoelectric sensor captures real-time flow rate, volume, duration; generates flow curves.
EMG Detection: Surface/needle electrodes record urethral sphincter EMG to evaluate detrusor-sphincter coordination.
Intelligent Analysis: Multi-channel signals synchronized; algorithms interpret pressure-flow, pressure-volume, EMG coordination; auto-generates clinical parameters and diagnostic evidence.
二、产品功能(Functions)
中文
核心检测
尿流率测定(自由尿流率)
膀胱压力 - 容积测定(储尿期 + 排尿期)
压力 - 流率测定(排尿期协同分析)
尿道压力分布测定(UPP)
尿道括约肌肌电图(EMG)
残余尿量测定
智能扩展
排尿日记:手机扫码记录饮水 / 排尿 / 失禁,自动统计报告
脱机检测:脱离主机独立测自然充盈膀胱压、压力 - 流率
智能交互:人脸识别、语音控制、遥控器(降低院感)
物联网:云存储、远程会诊、远程维护、手机查报告
自动分析:ICS 标准参数计算、曲线标注、报告生成
多通道同步:≥4 通道(Pves、Pabd、Q、EMG)同步采集
英文
Core Tests
Uroflowmetry (free flow)
Cystometry (filling + voiding phases)
Pressure-flow study (voiding coordination)
Urethral pressure profile (UPP)
Urethral sphincter electromyography (EMG)
Post-void residual (PVR) measurement
Smart Extensions
Micturition diary: mobile scan logs intake/voiding/incontinence; auto-report
Offline operation: standalone natural filling pressure & pressure-flow
Smart HMI: face recognition, voice control, remote (reduce HAIs)
IoT: cloud storage, tele-consultation, remote maintenance, mobile reports
Auto-analysis: ICS parameters, curve annotation, report generation
Multi-channel sync: ≥4 channels (Pves, Pabd, Q, EMG) simultaneous acquisition
三、产品特点(Product Features)
中文
双型号适配
UD2S:标准型,满足常规尿动力学检查
UD2P:型,含排尿日记、脱机、物联网全功能
高精度
压力:-50~200 cmH₂O,精度 ±1 cmH₂O
尿流率:0~1000 mL,误差≤±2%
采样率:≥10 Hz,动态捕捉无遗漏
智能便捷
模块化设计,即插即用
自动校准、自动建档、数据对比
非接触操控,降低交叉感染
临床合规
完全符合 ICS 标准
二类医疗器械(冀械注准 20242070151)
兼容无菌耗材,生物安全
场景覆盖
泌尿外科、妇产科、盆底康复、体检中心
成人 / 儿童 / 老年全人群适配
英文
Dual Models
UD2S: Standard, routine urodynamics
UD2P: Premium, full micturition diary, offline, IoT
High Precision
Pressure: -50~200 cmH₂O, ±1 cmH₂O accuracy
Flow: 0~1000 mL, ≤±2% error
Sampling: ≥10 Hz, full dynamic capture
Smart & Easy
Modular, plug-and-play
Auto-calibration, auto-filing, data comparison
Contactless control, reduce cross-infection
Clinical Compliance
Full ICS compliance
Class II medical device (Ji Xie Zhu Zhun 20242070151)
Sterile consumables, biosafe
Wide Application
Urology, OB/GYN, pelvic floor, health center
Adult/pediatric/geriatric compatible

四、技术参数(Technical Specifications)
中文
测量通道:4 通道(Pves、Pabd、尿流率 Q、EMG)
压力范围:-50~+200 cmH₂O;精度:±1 cmH₂O
尿流率:0~1000 mL;误差≤±2%;最大尿流率 0~50 mL/s
肌电(EMG):20 µV~1 mV;带宽 20~2000 Hz;抗干扰强
灌注泵:速度 1~50 mL/min;精度 ±3%;恒温(37℃±1℃)
尿道牵引器:4 档速度(0.5/1/2/4 mm/s);行程≥280 mm
数据存储:本地 + 云端;无限患者数据
显示:15.6 英寸高清触控屏
电源:AC 220V±10%,50/60 Hz
尺寸 / 重量:约 80×60×130 cm / 45 kg
传感器:一次性无菌压力 / 流率 / EMG 电极
英文
Channels: 4-ch (Pves, Pabd, Flow Q, EMG)
Pressure: -50~+200 cmH₂O; accuracy ±1 cmH₂O
Flow: 0~1000 mL; ≤±2% error; Qmax 0~50 mL/s
EMG: 20 µV~1 mV; bandwidth 20~2000 Hz; high anti-interference
Infusion Pump: 1~50 mL/min; ±3% accuracy; thermostatic (37℃±1℃)
UPP Puller: 4 speeds (0.5/1/2/4 mm/s); travel ≥280 mm
Storage: Local + cloud; unlimited patient data
Display: 15.6" HD touchscreen
Power: AC 220V±10%, 50/60 Hz
Dim./Wt: ~80×60×130 cm / 45 kg
Sensors: Disposable sterile pressure/flow/EMG electrodes
五、使用方法(Usage Instructions)
中文
术前准备
设备开机自检,校准压力 / 流率 / EMG
患者取截石位 / 坐位,清洁会阴、肛周
无菌操作:置入膀胱测压管、腹压管、EMG 电极
自由尿流率
患者自然排尿,设备记录尿流率曲线
膀胱测压(充盈期)
恒温灌注(37℃),速度 10~50 mL/min
记录初尿意、强烈尿意、最大膀胱容量、压力变化
排尿期(压力 - 流率)
患者自然排尿,同步记录 Pves、Pabd、Q、EMG
计算 Pdet、Qmax、Pdet@Qmax、BOOI 等参数
尿道压力(UPP)
牵引器匀速牵拉导管,测尿道闭合压、最大尿道压
术后
拔管,清洁皮肤
软件自动分析、生成报告、存储 / 打印
英文
Prep
Power on, self-test, calibrate pressure/flow/EMG
Patient lithotomy/sitting; clean perineum/anus
Sterile placement: bladder catheter, abdominal catheter, EMG electrodes
Free Uroflow
Patient voids naturally; flow curve recorded
Cystometry (Filling)
Thermostatic infusion (37℃), 10~50 mL/min
Log first desire, strong desire, max capacity, pressure
Voiding (Pressure-Flow)
Patient voids; Pves, Pabd, Q, EMG synchronized
Compute Pdet, Qmax, Pdet@Qmax, BOOI, etc.
UPP
Puller retracts catheter; measure closure pressure, max urethral pressure
Post-Test
Remove catheters, clean skin
Auto-analysis, report generation, save/print
六、适应症(Indications)
中文用于下尿路功能障碍的客观诊断与评估:
储尿障碍:尿频、尿急、夜尿增多、急迫性 / 压力性尿失禁
排尿障碍:排尿困难、尿等待、尿线细、尿不尽、尿潴留
前列腺增生(BPH)术前 / 术后功能评估
神经源性膀胱(脊髓损伤、脑卒中、帕金森)
盆底功能障碍(女性压力性尿失禁、盆底术后)
儿童遗尿、排尿功能异常
反复泌尿系感染病因排查
英文For objective diagnosis & assessment of lower urinary tract dysfunction:
Storage disorders: frequency, urgency, nocturia, urge/stress incontinence
Voiding disorders: difficulty, hesitancy, weak stream, incomplete emptying, retention
BPH pre/post-op functional evaluation
Neurogenic bladder (spinal cord injury, stroke, Parkinson’s)
Pelvic floor dysfunction (female stress incontinence, post-pelvic surgery)
Pediatric enuresis, voiding anomalies
Etiology of recurrent urinary tract infections
七、禁忌症(Contraindications)
中文
急性尿路感染(尿道炎、膀胱炎、肾盂肾炎)活动期
尿道狭窄、闭锁、严重损伤无法置管
膀胱内大量血块、结石、肿瘤(干扰测量)
严重出血倾向、凝血功能障碍(置管出血风险)
肛周感染、严重痔疮(腹压管置入禁忌)
对导管 / 电极材料过敏者
无法配合检查(意识障碍、不合作)
英文
Active acute urinary tract infection (urethritis, cystitis, pyelonephritis)
Urethral stricture, atresia, severe injury precluding catheterization
Large bladder clots, stones, tumors (measurement interference)
Severe bleeding diathesis, coagulopathy (hemorrhage risk)
Perianal infection, severe hemorrhoids (abdominal catheter contraindication)
Allergy to catheter/electrode materials
Inability to cooperate (impaired consciousness, uncooperative)
八、注意事项(Precautions)
中文
无菌操作:全程无菌,一次性耗材不重复使用
患者安全:充盈期控制速度,警惕膀胱过度扩张;疼痛 / 不适立即停止
感染防控:设备表面 75% 酒精消毒;非接触操控减少接触
信号质量:导管固定防移位;EMG 电极清洁去脂,排除肌电干扰
数据解读:结合临床症状,不可单靠参数诊断
特殊人群:儿童 / 老年需家属陪同;孕妇谨慎操作
设备维护:定期校准传感器;禁止自行拆机
紧急处理:出现血尿、剧痛、感染症状,立即对症处理
英文
Asepsis: Full sterile technique; single-use consumables not reused
Patient Safety: Controlled filling rate; avoid overdistension; stop on pain/discomfort
Infection Control: 75% alcohol wipe; contactless control to minimize touch
Signal Quality: Secure catheters; clean/degrease EMG sites; reject interference
Interpretation: Correlate with symptoms; not sole diagnostic
Special Populations: Pediatric/geriatric with escort; caution in pregnancy
Maintenance: Regular calibration; no disassembly
Emergencies: Treat hematuria, severe pain, infection promptly
九、存储条件(Storage Conditions)
中文
设备存储
温度:10~30℃
湿度:30%~75% RH(非冷凝)
避免阳光直射、潮湿、粉尘、强电磁干扰
通风干燥,水平放置
耗材存储
温度:5~30℃
湿度:15%~85% RH
密封、避光、防潮、防压
有效期内使用,无菌包装完好
英文
Device Storage
Temp: 10~30℃
Humidity: 30%~75%RH (non-condensing)
Avoid direct sun, moisture, dust, strong EMI
Ventilated, dry, horizontal
Consumables Storage
Temp: 5~30℃
Humidity: 15%~85%RH
Sealed, light-proof, moisture-proof, pressure-proof
Use within expiry; sterile package intact
十、其他信息(Manual Core Information)
中文
设备分类:二类医疗器械,用于下尿路功能检查,非治疗设备
合规认证:符合 ICS、ISO 13485
人员要求:经培训医护操作,熟悉尿动力学解读与应急处理
配套要求:必须使用原厂无菌导管、传感器、电极
维护保养
日常:表面清洁、干燥、防尘
定期:每月校准传感器,每年性能检测
禁止:浸泡、高压灭菌、改装
故障处理
信号差:查导管 / 电极 / 连接、干扰源
无灌注:查泵、管路、气泡
报警:查压力超限、设备异常,重启 / 报修
废弃处理:主机按电子废弃物;耗材按医疗废弃物处理
英文
Classification: Class II medical device, lower urinary tract function test (not therapeutic)
Certification: Ji Xie Zhu Zhun 20242070151; ICS, ISO 13485 compliant
Operator: Trained clinician; proficient in urodynamics & emergencies
Consumables: Only original sterile catheters, sensors, electrodes
Maintenance
Daily: clean, dry, dust-proof
Periodic: monthly calibration, annual performance test
Prohibited: immersion, autoclaving, modification
Troubleshooting
Poor signal: check catheters/electrodes/connections, interference
No infusion: check pump, tubing, air bubbles
Alarm: over-pressure, fault; restart/service
Disposal: Unit as e-waste; consumables as medical waste
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.
热门标签:厂家深度智能尿动力学分析仪HERA,UD2SHERA,UD2P,深度智能尿动力学分析仪,尿动力学分析仪HERA











