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厂商依露得力诺宁NONIN脑部与区域组织氧饱和度监护仪01-06-X100,01-06-X106
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厂商依露得力诺宁NONIN脑部与区域组织氧饱和度监护仪01-06-X100,01-06-X106
桂经理19117326863微xin同号
型号规格 01-06-3000、01-06-X100、01-06-X101、01-06-X102、01-06-X104、01-06-X106。 01-06-3000、01-06-X100、01-06-X101、01-06-X102、01-06-X104、01-06-X106。
结构及组成/主要组成成分 由主机、电源适配器、前置放大器（带连接线）、传感器组成。
适用范围/预期用途 01-06-3000型号：对患者组织氧饱和度进行监测；01-06-X100系列型号：对患者组织氧饱和度、脉搏氧饱和度和脉率进行监测。
产品储存条件及有效期 10年
脑部与区域组织氧饱和度监护仪是一款可以提供区域组织血氧饱和度（rSO2）的、多通道测量监护仪，可同时测量rSO2、SpO2和脉率。该设备设计用于头部和躯体位置的氧饱和度测量，可用于对新生儿、儿童和成人的连续实时监测，应用于医院、长期护理、实验室、运动队和各类急性环境中。适合在空间有限的医疗环境中使用，例如麻醉科、ICU、神经科、新生儿、急诊科以及院前急救与转运等。
产品特点
rSO2监测,SPO2监测,产品可同时监测rSO2、sPO2及脉率等。
传感器蝶形光路设计
双光源双传感器，增大测量区域。
不受其它物质影响，保证测量的准确性。
6通道监测
测量通道可选，最大可支持6通道同时监测
通道通过不同颜色及数字标识标识，并在显示界面已同步显示。
一、工作原理（Working Principle）
中文：采用近红外光谱（NIRS）技术，基于Beer-Lambert 定律，通过双光源、双探测器发射特定波长近红外光，穿透头皮、颅骨至大脑皮层，检测氧合血红蛋白（HbO₂）与脱氧血红蛋白（Hb）的光吸收差异；经专利算法校正皮肤色素、环境光干扰，计算局部脑氧饱和度（rSO₂），同时同步监测脉搏血氧饱和度（SpO₂）与脉率（PR）。
英文：Adopts Near-Infrared Spectroscopy (NIRS) technology based on the Beer-Lambert Law. Dual light sources and dual detectors emit specific-wavelength near-infrared light, penetrating the scalp, skull, and cerebral cortex to detect differences in light absorption between oxyhemoglobin (HbO₂) and deoxyhemoglobin (Hb). A proprietary algorithm corrects for skin pigment and ambient light interference to calculate regional cerebral oxygen saturation (rSO₂), while simultaneously monitoring pulse oxygen saturation (SpO₂) and pulse rate (PR)。
二、产品特点（Product Features）
中文
多参数同步监测：实时监测 rSO₂、SpO₂、PR，覆盖脑部与全身组织氧合状态。
多通道并行测量：6 通道独立监测，16 道光路设计，彩色编码自动识别通道，支持双侧脑区 / 多部位同时监测。
抗干扰强：双光源双探测器专利设计，有效降低皮肤色素、环境光、浅部组织干扰，数据稳定。
适用人群广：适配成人、儿童、新生儿，配套专用传感器，满足全年龄段临床需求。
智能预警与数据管理：参数异常声光报警，支持趋势图、病例存储与数据导出，便于临床分析。
便携易用：主机轻便，操作界面简洁，兼容主流监护系统，适合手术室、ICU、急诊等多场景。
英文
Multi-parameter Simultaneous Monitoring: Non-invasive real-time monitoring of rSO₂, SpO₂, and PR, covering cerebral and systemic tissue oxygenation.
Multi-channel Parallel Measurement: 6 independent monitoring channels with 16 optical paths, color-coded automatic channel identification, supporting simultaneous bilateral cerebral/multi-site monitoring.
Strong Anti-interference: Proprietary dual-source dual-detector design effectively reduces interference from skin pigment, ambient light, and superficial tissues, ensuring data stability.
Wide Applicability: Suitable for adults, children, and neonates with dedicated sensors, meeting clinical needs across all age groups.
Intelligent Alarm & Data Management: Audible and visual alarms for abnormal parameters, supports trend graphs, case storage, and data export for clinical analysis.
Portable & User-friendly: Lightweight host, simple interface, compatible with mainstream monitoring systems, ideal for operating rooms, ICUs, emergency departments, etc。
三、技术参数（Technical Parameters）
| 参数项（Item） | 中文（Chinese） | 英文（English） |
|---|---|---|
| 型号（Model） | 01-06-X100 | 01-06-X100 |
| 监测参数（Monitoring Parameters） | rSO₂、SpO₂、脉率（PR） | rSO₂, SpO₂, Pulse Rate (PR) |
| 通道数（Channels） | 6 通道（独立监测） | 6 Channels (Independent Monitoring) |
| 光路设计（Optical Path） | 16 道光路，双光源双探测器 | 16 Optical Paths, Dual Source & Dual Detector |
| 测量范围（Measurement Range） | rSO₂：0–100%；SpO₂：0–100%；PR：20–250 bpm | rSO₂: 0–100%; SpO₂: 0–100%; PR: 20–250 bpm |
| 数据存储（Data Storage） | ≥1000 组病例，支持趋势回放 | ≥1000 Patient Cases, Trend Playback Supported |
| 显示界面（Display） | 彩色液晶，参数 / 波形 / 趋势同屏 | Color LCD, Simultaneous Display of Parameters/Waveｆorms/Trends |
| 电源（Power） | AC 100–240V, 50/60Hz；内置锂电池（续航≥4h） | AC 100–240V, 50/60Hz; Built-in Li-ion Battery (≥4h) |
| 尺寸 / 重量（Size/Weight） | 约 250×180×80mm / 1.8kg | Approx. 250×180×80mm / 1.8kg |
| 注册证（Registration） | 赣械注准 20192070166 | Gan Xie Zhu Zhun 20192070166 |
四、使用方法（Usage Method）
中文
准备：连接主机、电源适配器与前置放大器，安装对应年龄段传感器（成人 / 儿童 / 新生儿），开机自检。
设置：进入系统界面，配置患者信息（ID、年龄、体重），设定 rSO₂/SpO₂/PR 报警阈值，选择监测通道。
传感器放置：清洁监测部位皮肤，将传感器贴附于双侧前额（脑氧监测）或指端（SpO₂监测），确保贴合无移位。
监测：启动监测，实时查看 rSO₂、SpO₂、PR 数值与波形，异常时触发声光报警，记录趋势数据。
结束：停止监测，移除传感器，清洁设备，导出病例数据，关机并妥善存放。
英文
Preparation: Connect the host, power adapter, and preamplifier. Install age-appropriate sensors (adult/pediatric/neonatal) and perｆorm power-on self-test.
Settings: Access the system interface, configure patient inｆormation (ID, age, weight), set alarm thresholds for rSO₂/SpO₂/PR, and select monitoring channels.
Sensor Placement: Clean the monitoring site skin, attach sensors to bilateral foreheads (cerebral oxygen monitoring) or fingertips (SpO₂ monitoring), ensuring secure fit without displacement.
Monitoring: Start monitoring, view real-time rSO₂, SpO₂, PR values and waveｆorms. Audible and visual alarms trigger for abnormalities; record trend data.
Termination: Stop monitoring, remove sensors, clean the device, export case data, power off, and store properly。
五、适应症（Indications）
中文：适用于麻醉科、ICU、神经外科、新生儿科、急诊科、心血管手术室，用于成人、儿童、新生儿的连续监测：
围手术期脑氧合评估（如心脏手术、颈动脉内膜剥脱术、神经外科手术）。
休克、脓毒症、脑损伤患者的组织氧供需平衡监测。
新生儿窒息、缺氧缺血性脑病的脑氧监测与预后评估。
重症患者全身组织氧合（如肾脏、肠道）与循环功能评估。
术中 / 术后脑缺血、缺氧的早期预警与干预指导。
英文: Applicable to Anesthesiology, ICU, Neurosurgery, Neonatology, Emergency Department, Cardiovascular Operating Room for non-invasive continuous monitoring of adults, children, and neonates:
Perioperative cerebral oxygenation assessment (e.g., cardiac surgery, carotid endarterectomy, neurosurgery).
Tissue oxygen supply-demand balance monitoring in patients with shock, sepsis, and brain injury.
Cerebral oxygen monitoring and prognostic evaluation for neonatal asphyxia and hypoxic-ischemic encephalopathy.
Systemic tissue oxygenation (e.g., kidney, intestine) and circulatory function assessment in critically ill patients.
Early warning and intervention guidance for intraoperative/postoperative cerebral ischemia and hypoxia。
六、禁忌症（Contraindications）
中文
监测部位皮肤破损、感染、炎症，或存在严重水肿、血肿，影响传感器贴合与信号采集。
对传感器材质（如粘合剂、光学材料）过敏者。
严重躁动、不配合，无法固定传感器的患者。
监测部位存在金属植入物（如颅骨钛板），干扰近红外光传输。
英文
Skin damage, infection, inflammation, severe edema, or hematoma at the monitoring site, impairing sensor adhesion and signal acquisition.
Allergy to sensor materials (e.g., adhesives, optical components).
Patients with severe agitation, non-cooperation, and inability to secure sensors.
Presence of ｍmbedl implants (e.g., cranial titanium plates) at the monitoring site, interfering with near-infrared light transmission.
七、注意事项（Precautions）
中文
仅由持证医护人员操作，严格遵循无菌操作规范，传感器为一次性使用，禁止复用以防交叉感染。
传感器贴附需平整无褶皱，避免压迫血管；脑氧监测优先选择前额无毛发、无损伤部位。
远离高频电刀、MRI 等强电磁设备，防止信号干扰；避免阳光直射传感器与主机屏幕。
定期校准设备，确保测量精度；电池电量不足时及时充电，避免监测中断。
报警需立即结合临床症状（如意识、血压、心率）综合判断，不可仅依赖设备数据；rSO₂＜50% 需紧急干预。
新生儿 / 儿童监测时，选择专用小尺寸传感器，固定牢固，防止脱落或压迫皮肤。
English
Operated only by certified medical staff. Strictly follow aseptic protocols; sensors are single-use and prohibited from reuse to prevent cross-infection.
Attach sensors smoothly without wrinkles; avoid compressing blood vessels. For cerebral oxygen monitoring, prefer hairless, intact forehead areas.
Keep away from strong electromagnetic equipment (e.g., high-frequency electrotomes, MRI) to avoid signal interference; protect sensors and host screen from direct sunlight.
Calibrate the device regularly to ensure measurement accuracy; charge the battery promptly when low to avoid monitoring interruption.
For alarms, immediately make a comprehensive judgment combining clinical symptoms (e.g., consciousness, blood pressure, heart rate); do not rely solely on device data. Emergency intervention is required if rSO₂ < 50%.
For neonates/children, use dedicated small-sized sensors, secure firmly to prevent detachment or skin compression。
八、存储条件（Storage Conditions）
中文：环境温度 5–40℃，相对湿度 30%–75%，无腐蚀性气体、通风干燥；避免阳光直射、剧烈震动与挤压；主机、传感器、配件分类存放，防潮防尘，传感器需密封保存于阴凉处。
English: Ambient temperature 5–40℃, relative humidity 30%–75%, no corrosive gas, well-ventilated and dry; avoid direct sunlight, severe vibration, and compression; store host, sensors, and accessories separately, moisture and dust proof; sensors must be sealed and stored in a cool place。
九、其他信息（Manual Core Inｆormation）
中文
产品组成：主机、电源适配器、前置放大器、专用传感器（成人 / 儿童 / 新生儿）、连接线、说明书。
医疗器械分类：二类医疗器械。
维护保养：每日清洁主机表面（用 75% 酒精擦拭），传感器一次性使用；每月自检校准，故障联系厂家售后。
安全标准：符合 YY 0709、YY 0834 等医疗设备安全标准，电磁兼容（EMC）合规。
数据导出：支持 USB 导出病例数据，格式兼容 Excel、PDF，便于临床科研与归档。
English
Product Composition: Host, power adapter, preamplifier, dedicated sensors (adult/pediatric/neonatal), connecting cables, manual.
Medical Device Classification: Class II medical device, Registration No.: Gan Xie Zhu Zhun 20192070166.
Maintenance: Clean the host surface daily (wipe with 75% alcohol); sensors are single-use. Perｆorm monthly self-calibration; contact the manufacturer for after-sales service in case of failure.
Safety Standards: Complies with medical device safety standards such as YY 0709 and YY 0834, and electromagnetic compatibility (EMC) requirements.
Data Export: Supports USB export of case data in Excel/PDF ｆormat, facilitating clinical research and medical record archiving。
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：厂商依露得力诺宁NONIN脑部与区域组织氧饱和度监护仪01-06-X10001-06-X106,诺宁脑氧,NONIN脑部与区域组织氧饱和度监护仪饱和度监护仪
