厂商直销美国柯惠脑部与区域血氧检测仪5100C
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厂商直销美国柯惠脑部与区域血氧检测仪5100C
桂经理19117326863微xin同号
结构及组成/主要组成成分 该产品由主机、电源线、前置放大器（带连接线）、传感器连接线、传感器组成，其中，传感器为清洁包装，一次性使用。
适用范围/预期用途 该产品作用在患者的头部前额、胸部、背部、腹部、肾部、腿 部、手臂，在临床中用于监测区域血氧饱和度并提供趋势监 测。 SAFB-SM 型号产品用于体重大于40kg的成人患者；SPFB型 号产品用于体重在2.5kg至40kg的新生儿、小儿（含婴儿）患 者；CNN/SNN型号产品适用于体重在2.5kg至5kg的新生儿、 小儿（含婴儿）患者。
一、工作原理（Working Principle）
中文采用近红外光谱技术（NIRS），通过传感器发射特定波长的近红外光，穿透头皮、颅骨至大脑皮层及局部组织。利用氧合血红蛋白（HbO₂）与脱氧血红蛋白（HHb）对不同波长近红外光的吸收差异，经空间分辨率算法（SRS） 处理，计算并实时显示局部组织（脑部、肾、肠道等）的区域血氧饱和度（rSO₂），连续监测局部氧供需平衡状态。
EnglishAdopts Near-Infrared Spectroscopy (NIRS) technology. The sensor emits near-infrared light of specific wavelengths, penetrating the scalp, skull to the cerebral cortex and local tissues. Based on the different absorption rates of oxyhemoglobin (HbO₂) and deoxyhemoglobin (HHb) to near-infrared light of varying wavelengths, and processed by Spatial Resolution Spectroscopy (SRS) algorithm, it calculates and displays regional oxygen saturation (rSO₂) of local tissues (brain, kidney, intestine, etc.) in real time, enabling non-invasive and continuous monitoring of local oxygen supply-demand balance.
二、产品功能（Functions）
中文
多部位区域血氧监测：实时监测脑部、肾脏、肠道等局部组织 rSO₂Medtronic
多通道同步检测：2/4 通道配置，可同时监测多部位氧合状态
参数动态显示：实时显示 rSO₂数值、趋势图、ΔO₂Hb、ΔHHb、ΔtHb
智能报警：传感器异常、低灌注、rSO₂超限、环境光干扰等多级报警
数据存储与导出：内置存储 28 例病例，USB 导出数据，支持长期趋势回顾
场景模式：适配手术室、ICU、NICU、心导管室 4 种临床模式
事件标记：40 + 临床事件标签，关联趋势图便于诊疗回溯
English
Multi-site Regional Oxygen Monitoring: Non-invasive real-time monitoring of rSO₂ in local tissues such as brain, kidney, intestineMedtronic
Multi-channel Synchronous Detection: 2/4-channel configuration, simultaneous monitoring of oxygenation at multiple sites
Dynamic Parameter Display: Real-time display of rSO₂ value, trend graph, ΔO₂Hb, ΔHHb, ΔtHb
Smart Alarm: Multi-level alarms for sensor abnormality, low perfusion, rSO₂ over-limit, ambient light interference
Data Storage & Export: Built-in storage for 28 cases, USB data export, supports long-term trend review
Scene Modes: 4 clinical modes for operating room, ICU, NICU, cardiac catheterization lab
Event Marking: 40+ clinical event tags, linked to trend graphs for diagnosis & treatment review
三、产品特点（Product Features）
中文
连续监测：无需穿刺，持续实时获取局部氧合数据Medtronic
深层组织测量：SRS 算法降低皮下干扰，反映脑 / 深层组织氧状态
低灌注适配：可检测 PI 低至 0.3%，适用于休克、低温等循环衰竭患者
多通道扩展：最多 4 通道，同步监测脑部 + 外周多部位
抗干扰强：抑制环境光、运动伪影，减少误报
数据管理：大容量存储、USB 导出、趋势分析、事件标记
全年龄段适用：配成人 / 小儿 / 新生儿专用传感器（适配 > 2.5kg 患者）
安全可靠：BFⅠ 类电击防护，内置电池断电续航约 20-30 分钟
English
Non-invasive Continuous Monitoring: No puncture needed, continuous real-time local oxygenation dataMedtronic
Deep Tissue Measurement: SRS algorithm reduces subcutaneous interference, accurately reflects brain/deep tissue oxygen status
Low Perfusion Adaptability: Detects PI as low as 0.3%, suitable for patients with circulatory failure (shock, hypothermia)
Multi-channel Expansion: Up to 4 channels, simultaneous brain + peripheral multi-site monitoring
Strong Anti-interference: Suppresses ambient light, motion artifacts, reduces false alarms
Data Management: Large-capacity storage, USB export, trend analysis, event marking
All-age Applicable: Equipped with adult/pediatric/neonatal dedicated sensors (for patients >2.5kg)
Safe & Reliable: BF Type I electric shock protection, built-in battery backup 20-30 minutes
四、技术参数（Technical Specifications）
中文
监测参数：区域血氧饱和度 rSO₂（15%–95%）、ΔO₂Hb、ΔHHb、ΔtHb
测量精度：±1%（80%-100% 区间）
通道数：标准 2 通道，可选 4 通道
刷新频率：≤5 秒 / 次
显示屏：≥10.5 英寸彩色液晶
主机尺寸：20×30.75×5.1cmMedtronic
主机重量：4.95kgMedtronic
供电：AC 100–240V 50/60Hz；内置 12VDC 电池，续航约 20 分钟
接口：USB 2.0、RS-232
工作环境：温度 16–32℃，湿度 20%–80%
存储环境：温度 0–50℃，湿度 15%–95%Medtronic
防护等级：BFⅠ 类
适用人群：体重 > 2.5kg 新生儿、婴儿、儿童、成人
English
Monitored Parameters: Regional oxygen saturation rSO₂ (15%–95%), ΔO₂Hb, ΔHHb, ΔtHb
Measurement Accuracy: ±1% (80%-100% range)
Channels: Standard 2-channel, optional 4-channel
Refresh Rate: ≤5 seconds/time
Display: ≥10.5-inch color LCD
Host Dimensions: 20×30.75×5.1cmMedtronic
Host Weight: 4.95kgMedtronic
Power Supply: AC 100–240V 50/60Hz; Built-in 12VDC battery, backup ~20 minutes
Interfaces: USB 2.0, RS-232
Operating Environment: Temp 16–32℃, Humidity 20%–80%
Storage Environment: Temp 0–50℃, Humidity 15%–95%Medtronic
Protection Class: BF Type I
Applicable Population: Neonates, infants, children, adults >2.5kg
五、使用方法（Instructions for Use）
中文
准备：设备通电 / 装电池；检查传感器、线缆完好；清洁患者监测部位皮肤
开机：按电源键开机，系统自检，进入预设界面
配置：选择临床场景（手术室 / ICU 等）；设置患者信息、通道、传感器类型、报警阈值
贴传感器：撕开一次性传感器贴膜，贴于前额（脑部）/ 肾区等部位，按压固定
监测：进入监护界面，实时显示 rSO₂、趋势、参数；异常时自动报警
事件标记：临床操作时标记事件（插管 / 输血等），关联趋势记录
数据导出：监测结束，USB 插入导出病例数据
关机：移除传感器→关机→清洁设备与线缆
English
Preparation: Power on/insert battery; inspect sensor & cable integrity; clean patient's monitoring site skin
Power On: Press power button, system self-test, enter preset interface
Configuration: Select clinical scenario (OR/ICU etc.); set patient info, channels, sensor type, alarm thresholds
Sensor Application: Peel disposable sensor, apply to forehead (brain)/renal area, press to fix
Monitoring: Enter monitoring interface, real-time rSO₂, trend, parameters display; automatic alarm on abnormality
Event Marking: Mark events (intubation/transfusion etc.) during clinical procedures, link to trend record
Data Export: After monitoring, insert USB to export case data
Shutdown: Remove sensor → power off → clean device & cables
六、适应症（Indications）
中文适用于体重 > 2.5kg的新生儿、婴儿、儿童及成人患者：
术中 / 术后脑部、肾脏、肠道等部位区域血氧饱和度（rSO₂）连续监测
监测缺血 / 低灌注风险（心脑血管手术、休克、体外循环、ICU 重症监护）
辅助评估局部氧供需平衡、循环灌注状态
新生儿 / 儿童 NICU、PICU 脑氧与外周组织氧合监测
EnglishFor patients >2.5kg (neonates, infants, children, adults):
Continuous regional oxygen saturation (rSO₂) monitoring of brain, kidney, intestine during/after surgery
Monitoring ischemia/low perfusion risk (cardiovascular/cerebral surgery, shock, extracorporeal circulation, ICU critical care)
Auxiliary evaluation of local oxygen supply-demand balance, circulatory perfusion status
Cerebral & peripheral tissue oxygenation monitoring in NICU/PICU for neonates/children
七、禁忌症（Contraindications）
中文
监测部位皮肤破损、感染、炎症、严重水肿
对传感器黏胶材质过敏患者
无法配合固定传感器、剧烈躁动不配合患者
监测部位存在金属植入物、异物干扰近红外光穿透
English
Damaged, infected, inflamed skin or severe edema at monitoring site
Patients allergic to sensor adhesive material
Patients unable to cooperate with sensor fixation, severe restlessness
Metal implants/foreign bodies at monitoring site interfering near-infrared light penetration
八、注意事项（Precautions）
中文
仅供临床医护操作，不作为诊断 / 治疗依据
传感器一次性使用，禁止复用、消毒
贴传感器避开毛发、疤痕、血管、金属物，确保皮肤贴合
避免强光直射、传感器移动 / 受压、电磁干扰
低体温、低血压、血管收缩可能影响测量准确性
报警仅作提示，需结合临床综合判断
定期校准 / 维护，故障立即停用
新生儿 / 婴儿选用专用传感器，固定牢固防脱落
English
Operated only by clinical staff, not sole basis for diagnosis/treatment
Sensors single-use only, no reuse/sterilization
Apply sensor away from hair, scars, vessels, ｍmbedl; ensure skin adhesion
Avoid direct strong light, sensor movement/pressure, electromagnetic interference
Hypothermia, hypotension, vasoconstriction may affect accuracy
Alarms for reference only; clinical comprehensive judgment required
Regular calibration/maintenance; stop use immediately if faulty
Use dedicated sensors for neonates/infants, fix firmly to prevent detachment
九、存储条件（Storage Conditions）
中文
主机：温度 0–50℃，相对湿度 15%–95%（无凝露），气压 86–106kPaMedtronic
传感器：密封干燥，温度 10–30℃，避免阳光直射、高温、潮湿、腐蚀环境
远离电磁干扰、尖锐物、化学品；存储前清洁干燥Medtronic
English
Host: Temp 0–50℃, RH 15%–95% (non-condensing), air pressure 86–106kPaMedtronic
Sensors: Sealed & dry, temp 10–30℃, avoid direct sunlight, high temp, humidity, corrosive environment
Keep away from EMI, sharp ｏbjects, chemicals; clean & dry before storageMedtronic
十、说明书核心信息（Manual Core Inｆormation）
中文
产品组成：主机、前置放大器（5100C-PA/PB）、传感器线缆、一次性传感器
安全标准：符合 IEC 60601-1、GB 9706.1，BFⅠ 类防护
校准：出厂校准，临床无需定期校准
维护：外壳 75% 酒精擦拭；传感器 / 线缆一次性使用
保修：按厂家标准保修条款执行Medtronic
警示：监测数据为辅助参考，不能替代临床评估
English
Product Composition: Host, preamplifier (5100C-PA/PB), sensor cables, disposable sensors
Safety Standards: Complies with IEC 60601-1, GB 9706.1, BF Type I protection
Calibration: Factory calibrated, no regular clinical calibration needed
Maintenance: Wipe housing with 75% alcohol; sensors/cables single-use
Warranty: Per manufacturer's standard warranty termsMedtronic
Warning: Monitoring data for auxiliary reference only, not substitute for clinical assessment
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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