厂家供应费森尤斯人体成分分析仪BCM
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厂家供应费森尤斯人体成分分析仪BCM
桂经理19117326863微xin同号
管理类别
第二类
型号规格
BCM
结构及组成/主要组成成分
该产品由主机、电极连接电缆、一次性电极、测试盒、电源适配器和儿童用一次性电极组成，其中含有嵌入式软件组件BCM3.3。
适用范围/预期用途
该产品通过对人体成份进行生物阻抗频谱测量估算水合状态，从中推算出水分过多的程度，也允许对身体成份进行连续测量并可计算出肌肉组织指数和脂肪组织指数，可测定尿素分布容积，以计算透析剂量(Kt/V)。该产品适用于透析治疗和体外治疗范围内的肾脏疾病患者。该产品可在透析中心、医院、医疗实践中使用，仅供具有专业知识和接受过正式培训的人员进行安装、操作和使用。该产品所显示的身体成分和体液平衡参数是基于生理模型计算出，应仅被视为参考信息，不应仅基于该产品所提供的信息而得出治疗决定和治疗参数。
一、工作原理（Working Principle）
中文
采用 生物电阻抗光谱技术（BIS, Bio-Impedance Spectroscopy）：
多频电流穿透：设备向人体发送 50 种不同频率（5kHz–1000kHz） 的极微弱交流电（<1mA）。
组织导电性差异：
低频电流（<50kHz）：无法穿透细胞膜，仅在 细胞外液（ECW） 中流动。
高频电流（>100kHz）：可穿透细胞膜，在 细胞内液（ICW） 和 细胞外液（ECW） 中同时流动。
阻抗测量与计算：通过手脚远端电极测量电压差，计算出不同组织的电阻抗。结合生理模型，精确区分 总水量（TBW）、细胞外液（ECW）、细胞内液（ICW），进而算出 水分过多量（Overhydration）、瘦体重（肌肉量）、脂肪量。
English
Adopts Bio-Impedance Spectroscopy (BIS) Technology:
Multi-Frequency Current Penetration: The device sends 50 different alternating current frequencies (5kHz–1000kHz) of extremely low intensity (<1mA) through the body.
Differential Tissue Conductivity:
Low-frequency currents (<50kHz): Cannot cross cell membranes, flow only through Extracellular Water (ECW).
High-frequency currents (>100kHz): Penetrate cell membranes, flow through both Intracellular Water (ICW) and Extracellular Water (ECW).
Impedance Measurement & Calculation: Voltage is measured via distal electrodes on hands and feet to calculate tissue impedance. Using advanced physiological models, it precisely partitions Total Body Water (TBW), Extracellular Water (ECW), and Intracellular Water (ICW), then computes Overhydration (OH), Lean Tissue Mass (LTM), and Adipose Tissue Mass (FM).
二、核心功能（Core Functions）
表格
中文功能 English Function
水分状态评估：测量细胞内 / 外液、总水量、水分过多量（OH） Precise Hydration Status: Measures ICW, ECW, TBW, Overhydration (OH)
干体重测定：为透析患者设定目标干体重，指导超滤 Dry Weight Determination: Sets target dry weight for dialysis, guides ultrafiltration
人体成分分析：瘦体重（肌肉量）、脂肪量、身体细胞量（BCM） Body Composition Analysis: Lean Tissue Mass, Fat Mass, Body Cell Mass (BCM)
营养状况评估：判断肌少症、营养不良、肥胖风险 Nutritional Assessment: Identifies sarcopenia, malnutrition, obesity risk
实时监测与趋势分析：长期跟踪体液及成分变化，评估疗效 Trend Monitoring: Long-term tracking of fluid/composition changes, therapy evaluation
数据管理：存储患者数据，生成临床报告 Data Management: Stores patient data, generates clinical reports
三、产品特点（Product Features）
中文
准 BIS 技术：50 频段光谱测量（5–1000kHz），远超普通单频 / 多频 BIA，精度高、重复性好。
透析专用模型：算法专为肾衰、水肿患者优化，不受透析液、内瘘干扰，临床验证准确。
、快速、安全：非侵入性，测量仅需 <1 分钟；电流极微弱（<1mA），无电击感、无辐射。
操作极简：贴电极→输入信息→启动，一键测量，医护 / 技师快速上手。
便携设计：主机轻便，带拉杆箱，床旁、透析室、病房移动使用。
临床级可靠性：CE、ISO 13485 认证，数据支持医疗决策。
抗干扰性强：采用四电极远端测量，降低皮肤接触阻抗、运动伪影干扰。
English
Gold-Standard BIS Technology: 50-frequency spectroscopy (5–1000kHz), superior to standard BIA; high accuracy, excellent repeatability.
Dialysis-Optimized Algorithm: Specifically calibrated for renal failure/edema patients; unaffected by dialysis fluid or fistulas, clinically validated.
Non-Invasive, Fast & Safe: Non-invasive, measurement in <1 minute; ultra-low current (<1mA), no sensation, no radiation.
Extremely Easy Operation: Apply electrodes → enter data → start; one-touch measurement, intuitive for staff.
Portable Design: Lightweight main unit with trolley; bedside, mobile use in dialysis units/wards.
Clinical-Grade Reliability: CE, ISO 13485 certified; data supports critical medical decisions.
High Anti-Interference: Tetra-polar distal measurement minimizes skin contact impedance and motion artifacts.
四、技术参数（Technical Specifications）
表格
参数（中） Parameter (En) 规格值
测量技术 Measurement Technology 生物电阻抗光谱法 (BIS)
测量频率 Frequencies 50 个频段，5kHz – 1000kHz
测量电流 Excitation Current <1mA (安全，无感)
测量时间 Measurement Time 约 20–40 秒
测量指标 Parameters OH (水分过多), ECW, ICW, TBW, 瘦体重，脂肪量，BMI
电极方式 Electrode Type 4 片一次性贴片 (双手 / 双脚背远端)
适用人群 Target Population 成人 (18–99 岁)
身高范围 Height Range 100–220 cm
体重范围 Weight Range 20–250 kg
数据接口 Connectivity USB, 可选蓝牙 / WiFi
显示屏 Display 彩色液晶触摸屏 (LCD Touchscreen)
电源 Power AC 100–240V, 内置充电电池
主机尺寸 Dimensions 约 35 × 30 × 15 cm
主机重量 Weight 约 5 kg (便携)
安全认证 Safety Class IIa, CE, ISO 13485
五、使用方法（Usage Instructions）
中文
1. 测量前准备
患者准备：
测量前 平卧静息 5–10 分钟，保持稳定。
空腹 / 餐后 2 小时，禁止剧烈运动、大量饮水。
去除手脚金属饰品、膏药；皮肤用 酒精清洁，干燥后贴电极。
体毛浓密处需 剃毛，确保电极贴合。
设备准备：开机自检，连接电极线，输入患者信息（年龄、性别、身高、体重）。
2. 电极粘贴（四电极法）
右手背、左手背、右足背、左足背 远端位置各贴 1 片电极。
确保电极 紧密贴合、无气泡、无褶皱。
3. 执行测量
患者平卧，四肢自然分开，不接触身体，保持静止。
点击 开始，等待 20–40 秒 完成，期间勿移动、说话。
测量完成，自动生成报告，查看 水分过多量 (OH)、肌肉量、脂肪量。
4. 结束与清洁
取下电极片（一次性废弃）。
用酒精擦拭电极线接头，设备关机、充电备用。
English
1. Pre-Measurement Preparation
Patient Prep:
Supine rest for 5–10 minutes before measurement for stability.
Fasting or 2 hours post-meal; no vigorous exercise, no large fluid intake.
Remove ｍmbedl/jewelry; clean skin with alcohol swab and dry before applying electrodes.
Shave excessive hair at electrode sites for good contact.
Device Prep: Power on self-test, connect leads, input patient data (age, gender, height, weight).
2. Electrode Placement (Tetra-polar)
Apply one electrode to distal: right/left hand dorsum, right/left foot dorsum.
Ensure firm adhesion, no air bubbles, no folds.
3. Perｆorming Measurement
Patient lies supine, limbs apart, not touching body, motionless.
Press Start, wait 20–40 seconds; no movement/talking.
Report auto-generates; review Overhydration (OH), Lean Mass, Fat Mass.
4. Termination & Cleaning
Remove and discard electrodes (single-use).
Clean lead connectors with alcohol; power off, charge for next use.
六、适应症（Indications）
中文
血液透析 / 腹膜透析患者：测定干体重，评估水分潴留（OH），指导透析超滤量。
心衰、肾病、肝硬化：评估水肿程度、体液分布，监测利尿疗效。
营养不良 / 肥胖评估：测量肌肉量、脂肪量，诊断肌少症、肥胖。
重症监护：监测容量状态、营养代谢，指导液体管理。
老年医学：评估衰弱、肌肉流失、水合状态。
术后康复：监测体液平衡、营养恢复。
English
Hemodialysis/Peritoneal Dialysis Patients: Precise dry weight determination, assess fluid overload (OH), guide dialysis ultrafiltration.
Heart Failure, Renal Disease, Cirrhosis: Evaluate edema, fluid distribution, monitor diuretic efficacy.
Malnutrition/Obesity: Measure muscle/fat mass, diagnose sarcopenia, obesity.
Critical Care: Monitor volume status, nutrition ｍmbedbolism, guide fluid management.
Geriatrics: Assess frailty, muscle loss, hydration.
Postoperative Rehabilitation: Monitor fluid balance, nutritional recovery.
七、禁忌症（Contraindications）
中文
绝对禁忌
植入心脏起搏器、ICD 除颤器 患者（电流干扰设备运行）。
孕妇（理论电流可能影响胎儿）。
四肢截肢、严重皮肤烧伤 / 感染（无法贴电极）。
连接 ECG、有创血压、电刀 等其他电子设备时。
相对禁忌（慎用）
严重心律失常、血流动力学不稳定。
体内大量金属植入物（钢板、假体），可能干扰信号。
极高水肿、肢体高度肿胀（影响精度）。
English
Absolute Contraindications
Patients with pacemakers, ICDs (current interferes with device function).
Pregnancy (theoretical risk to fetus).
Amputation, severe burns/infection (cannot apply electrodes).
Connected to ECG, invasive BP, electrosurgical devices.
Relative Contraindications (Caution)
Severe arrhythmia, hemodynamic instability.
Extensive ｍmbedl implants (plates, prosthetics) may distort signals.
Severe anasarca, massive limb swelling (reduces accuracy).
八、注意事项（Precautions）
中文
严格遵守禁忌症：起搏器 / 孕妇绝对禁止测量。
皮肤处理：电极部位必须 清洁、干燥、无破损；酒精擦拭后待干。
体位与静止：必须 平卧、四肢分开、完全静止，否则数据失真。
时间控制：透析患者应在 透析前 测量，避免透析中 / 后水肿变化影响。
环境要求：室温 22–26℃，避免过冷 / 过热导致血管收缩 / 扩张。
电极使用：一次性电极，严禁复用；确保粘贴牢固。
数据准确性：身高、体重输入必须精确（误差 < 1cm/<0.5kg）。
设备维护：定期校准；避免摔落、潮湿、高温。
English
Strict Adherence to Contraindications: No measurement on pacemaker/pregnant patients.
Skin Preparation: Electrode sites must be clean, dry, intact; dry thoroughly after alcohol swab.
Position & Stillness: Supine, limbs apart, motionless to avoid invalid data.
Timing: Dialysis patients measured before treatment, not during/after.
Environment: Room temp 22–26°C to avoid vasoconstriction/dilation.
Electrodes: Single-use only, no reapplication; ensure firm adhesion.
Data Accuracy: Precise height/weight input (error <1cm/<0.5kg).
Device Care: Regular calibration; protect from shock, moisture, heat.
九、存储条件（Storage Conditions）
中文
温度：-10℃ ~ +50℃
湿度：10%–90% RH，无冷凝
环境：干燥、通风、避光、防尘、防腐蚀、防电磁干扰
禁止：冷冻、阳光直射、高温、潮湿、液体浸泡、剧烈震动
电池：长期存储需 充满电，每 3 个月补充充电一次
电极片：15–25℃ 室温 保存，有效期 2 年，无菌、干燥
English
Temperature: -10°C to +50°C
Humidity: 10–90% RH, non-condensing
Environment: Dry, ventilated, dark, dust/corrosion/EMI-proof
Prohibited: Freezing, direct sun, heat, moisture, immersion, shock
Battery: Fully charge for long-term storage; recharge every 3 months
Electrodes: Store at 15–25°C (room temp), 2-year shelf life, sterile, dry
十、说明书核心信息（Manual Key Inｆormation）
中文
产品名称：人体成分分析仪（Body Composition Monitor, BCM）
生产厂家：Fresenius Medical Care（德国费森尤斯医疗）
注册分类：Class IIa 医疗器械
核心原理：50 频段生物电阻抗光谱法（BIS）
临床用途：透析干体重评估、体液管理、营养状况分析
安全警告
禁止用于起搏器、孕妇。
禁止与其他电子医疗设备同时使用。
医护人员操作，非专业人员勿用。
电极一次性使用，皮肤破损处禁用。
维护：定期校准，清洁外壳，电池维护。
责任声明：未按说明书操作导致的 设备损坏、患者伤害，由使用者负责。
English
Product Name: Body Composition Monitor (BCM)
Manufacturer: Fresenius Medical Care (Germany)
Classification: Class IIa Medical Device
Core Principle: 50-frequency Bio-Impedance Spectroscopy (BIS)
Clinical Use: Dry weight assessment, fluid management, nutritional analysis
Safety Warnings
Do NOT use on pacemaker/pregnant patients.
Do NOT use with other electronic medical devices connected.
For professional use only by trained medical staff.
Electrodes single-use; do not apply on broken skin.
Maintenance: Regular calibration, external cleaning, battery care.
Liability: User responsible for device damage/patient harm from improper use.
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.
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