厂商爱德华脑部与区域血氧监测传感器FSESL,FSESM,FSESS
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厂商爱德华脑部与区域血氧监测传感器FSESL,FSESM,FSESS
桂经理19117326863微xin同号
产品名称脑部与区域血氧监测传感器TISSUE OXIMETER SENSORS
管理类别第二类
型号规格FSESL、FSESM、FSESS
结构及组成/主要组成成分 产品由LED灯、光电探测器、接头部分组成，非无菌提供，一次性使用。
适用范围/预期用途 该产品与爱德华兹公司（Edwards Lifesciences LLC）生产的具有脑部与区域血氧监测功能的病人监护仪配合使用，用于辅助监测传感器下脑及其他组织的氧饱和度，适用于有血流减少或无血流的有缺血状态风险的患者。不同型号适用人群如下：FSESL型号传感器适用于体重≥40 kg的成人。FSESM型号传感器适用于体重≥3 kg的小儿。FSESS型号传感器适用于体重＜8 kg小儿的脑部使用和体重＜5kg小儿的非脑部使用。
一、型号与规格
• FSESL：大号（成人 ≥40kg）
• FSESM：中号（儿童 ≥3kg）
• FSESS：小号（小儿/新生儿 <8kg）
二、产品彩页（中文）
三、核心参数
• 技术：近红外光谱（NIRS）
• 用途：连续监测局部脑组织氧饱和度（StO₂）
• 适用：ForeSight Elite 主机/模块
• 包装：20 个/盒
一、工作原理 (Working Principle)
中文基于近红外光谱技术 (NIRS)，采用5 波长近红外光 (690/730/770/810/870 nm) 穿透组织。利用氧合血红蛋白 (HbO₂) 与还原血红蛋白 (Hb) 对不同波长光的吸收差异，通过多检测器测量反射光衰减，经专利算法计算局部组织血氧饱和度 (StO₂)，直接反映脑部 / 区域组织动静脉混合血的氧合状态，无脉搏亦可测量。
EnglishBased on Near-Infrared Spectroscopy (NIRS) with 5 wavelengths (690/730/770/810/870 nm). Utilizes distinct absorption of oxyhemoglobin (HbO₂) and deoxyhemoglobin (Hb). Multiple detectors measure attenuated reflected light; proprietary algorithms compute absolute tissue oxygen saturation (StO₂), reflecting mixed arteriovenous oxygenation—operates without pulsatility.
二、产品功能 (Functions)
中文
连续监测脑部（前额）及躯体区域绝对 StO₂与趋势
提供StO₂实时数值、动态趋势、变化率
适配FORE-SIGHT ELITE主机 / 模块，支持报警、数据记录、联网
双部位同步监测（脑 + 躯体）
无脉搏 / 低灌注状态下稳定监测
English
Continuous non-invasive monitoring of absolute & trending StO₂ (cerebral/somatic)
Displays real-time StO₂, trends, rate of change
Integrates with FORE-SIGHT ELITE: alarms, data logging, connectivity
Dual-site (cerebral + somatic) simultaneous monitoring
Stable in pulseless/low-perfusion states
三、产品特点 (Features)
中文
5 波长 NIRS：业界最多波长，精度更高、抗干扰更强
深穿透 (2.5 cm)：覆盖成人头皮 - 皮层距离，监测更准确
全年龄段覆盖：
FSESL (Large)：≥40kg 成人
FSESM (Medium)：15–40kg 儿童
FSESS (Small)：3–15kg 小儿 / 新生儿
柔性黏贴：贴合头部、低刺激、单次最长 30 天
无脉搏测量：适用于 ECMO、循环骤停等场景
抗肤色、温度、运动干扰
一次性无菌、单人单用
English
5-wavelength NIRS: Industry-leading accuracy & interference rejection
2.5 cm depth penetration: Optimized for adult scalp-to-cortex distance
Full age range:
FSESL (Large): ≥40kg Adult
FSESM (Medium): 15–40kg Pediatric
FSESS (Small): 3–15kg Infant/Neonate
Flexible adhesive: Comfortable, biocompatible (up to 30 days)
Pulseless operation: Works during ECMO, circulatory arrest
Robust to pigmentation, temperature, motion
Sterile, single-patient disposable
四、技术参数 (Specifications)
中文
测量指标：局部组织血氧饱和度 StO₂ (0–100%)
波长：690、730、770、810、870 nm
精度：3% ARMS（45–85% StO₂）
适用体重
FSESL：≥40 kg
FSESM：15–40 kg
FSESS：3–15 kg
监测部位：前额（脑）、肌肉组织（躯体）
传感器类型：一次性、柔性、无菌黏贴
使用时长：≤30 天（连续）
兼容设备：FORE-SIGHT ELITE 主机 / 模块
English
Parameter: Absolute Tissue Oxygen Saturation StO₂ (0–100%)
Wavelengths: 690, 730, 770, 810, 870 nm
Accuracy: 3% ARMS (45–85% StO₂)
Patient Weight
FSESL: ≥40 kg
FSESM: 15–40 kg
FSESS: 3–15 kg
Sites: Forehead (cerebral), skeletal muscle (somatic)
Sensor: Disposable, flexible, sterile adhesive
Duration: ≤30 days continuous
Compatibility: FORE-SIGHT ELITE monitor/module
五、使用方法 (Instructions for Use)
中文
拆封、检查传感器完好无菌
清洁干燥监测部位（前额 / 肌肉区）
撕去贴纸，居中贴于前额（避开毛发 / 伤口）
连接传感器至Preamp 电缆（听到 “咔嗒”）
主机选择对应传感器型号与部位
确认StO₂数值稳定显示
每12 小时检查皮肤与黏贴状态
连续使用≤30 天或脱落时更换
结束：轻柔揭除、关机、整理线缆
English
Open package, inspect sterile & intact
Clean & dry application site
Remove liner, apply center on forehead (avoid hair/wounds)
Connect to Preamp cable (tactile click)
Select sensor type & site on monitor
Confirm stable StO₂ display
Inspect skin/adhesion q12h
Replace ≤30 days or if loose
End: Gently peel off, power down, clean cables
六、适应症 (Indications)
中文医疗环境下辅助监测局部组织血氧饱和度 (StO₂)：
FSESL：≥40kg 成人 / 青少年，脑 + 躯体绝对 StO₂
FSESM：15–40kg 儿童，脑 + 躯体绝对 StO₂
FSESS：3–15kg 小儿 / 新生儿，脑 + 躯体绝对 StO₂
适用：手术麻醉、ICU、NICU、神经 / 心胸外科、ECMO、低灌注
EnglishAdjunctive StO₂ monitoring in healthcare:
FSESL: ≥40kg adults, absolute cerebral/somatic StO₂
FSESM: 15–40kg pediatric, absolute cerebral/somatic StO₂
FSESS: 3–15kg infant/neonate, absolute cerebral/somatic StO₂
Use: OR, ICU, NICU, neurosurgery, cardiac surgery, ECMO, low perfusion
七、禁忌症 (Contraindications)
中文
对传感器黏胶 / 材料过敏者
监测部位破损、感染、炎症皮肤
MRI 检查中（含金属，风险致灼伤）
监测部位空间不足无法正确粘贴
非医疗 / 家庭环境使用
English
Hypersensitivity to sensor adhesive/materials
Broken, infected, inflamed skin at site
During MRI (ｍmbedl components, burn risk)
Insufficient site area for proper placement
Not for home/non-medical use
八、注意事项 (Warnings & Precautions)
中文
仅供医护人员操作、处方使用
辅助设备：不可替代临床判断
每12 小时检查皮肤；过敏 / 红肿立即更换
连续≤30 天更换传感器
禁止覆盖眼 / 鼻 / 口、毛发、伤口、水肿区
传感器一次性、无菌、单人单用
远离高频电刀、MRI、强光干扰
读数异常：检查位置、连接、患者状态
勿让患者压在传感器 / 线缆上
English
For qualified medical personnel only
Adjunct device: Do not rely solely for decisions
Inspect skin q12h; change site if irritation
Replace sensor ≤30 days
Avoid eyes/nose/mouth, hair, wounds, edema
Sterile, single-patient, disposable
Keep away from electrosurgery, MRI, intense light
Abnormal reading: check position, connection, patient
Do not lay patient on sensor/cable
九、存储条件 (Storage)
中文
温度：15–30°C (59–86°F)
湿度：15–90% RH，无冷凝
避免阳光直射、高温、潮湿、腐蚀性气体
密封、干燥、阴凉、无菌环境保存
有效期：见包装标签
English
Temperature: 15–30°C (59–86°F)
Humidity: 15–90% RH, non-condensing
Protect from direct sunlight, heat, moisture, corrosive gases
Store sealed, dry, cool, sterile
Expiry: See package label
十、说明书核心信息 (Manual Core Summary)
中文
分类：二类医疗器械，无菌、一次性
预期用途：辅助监测绝对 StO₂，非诊断设备
型号与体重：FSESL (≥40kg)、FSESM (15–40kg)、FSESS (3–15kg)
精度：3% ARMS（45–85% StO₂）
监测部位：前额（脑）、骨骼肌（躯体）
使用时长：≤30 天
报警：StO₂上下限、传感器脱落、信号丢失
** disposal ：按医疗废弃物 ** 处理
English
Classification: Class II medical device, sterile, single-use
Intended Use: Adjunct absolute StO₂ monitor; not diagnostic
Models/Weight: FSESL (≥40kg), FSESM (15–40kg), FSESS (3–15kg)
Accuracy: 3% ARMS (45–85% StO₂)
Sites: Forehead (cerebral), skeletal muscle (somatic)
Duration: ≤30 days
Alarms: StO₂ limits, sensor off, loss of signal
Disposal: 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.
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