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厂家直供内特斯大脑皮层刺激器Nicolet Cortical Stimulator
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厂家直供内特斯大脑皮层刺激器Nicolet Cortical Stimulator
桂经理19117326863微xin同号
管理类别
第二类
型号规格
Nicolet Cortical Stimulator
结构及组成/主要组成成分
产品有刺激器主机（控制装置），适配器组成。
适用范围/预期用途
该产品预期产生并提供于大脑皮层刺激的脉冲电流。
一、工作原理 (Working Principle)
中文通过双相恒流脉冲输出技术，由刺激控制单元（SCU）产生、隔离的双相方波电脉冲，经刺激切换单元（SSU）定向传导至颅内电极阵列或一次性双极探针，直接作用于大脑皮层特定功能区。设备实时监测输出电流，确保实际刺激强度与设定值一致。电刺激激活皮层神经元，诱发对应功能反应（如运动、语言、感觉）或抑制异常放电，配合 EEG 系统同步记录脑电信号，实现大脑功能区定位映射与术中神经监护。
EnglishAdopts biphasic constant-current pulse technology. The Stimulus Control Unit (SCU) generates precise, isolated biphasic square-wave electrical pulses, which are directed via the Stimulus Switching Unit (SSU) to intracranial electrode arrays or disposable bipolar probes, targeting specific functional areas of the cerebral cortex. The device monitors output current in real time, ensuring actual stimulation intensity matches set values. Electrical stimulation activates cortical neurons, evoking corresponding functional responses (motor, speech, sensory) or suppressing abnormal discharges. Synchronized EEG recording enables precise functional brain mapping and intraoperative neural monitoring.
二、功能 (Functions)
中文
大脑功能区定位：映射运动、语言、感觉、视觉中枢，指导脑肿瘤 / 癫痫灶切除
双模式刺激：单脉冲模式（定位诊断）、连续脉冲模式（功能测试 / 术中监护）
术中癫痫控制：Ictal Disrupt 功能，快速抑制刺激后异常放电（后放电）
系统集成：兼容 NicoletOne/NeuroWorks EEG 系统，参数审计、自动报告、标注
安全监测：实时误差检测、剩余刺激时间、电流值双重显示
独立 / 联机两用：可单机操作，也可与 EEG 系统联动实现闭环监护
English
Functional Brain Mapping: Precisely locates motor, speech, sensory, visual cortices, guiding tumor/epilepsy focus resection
Dual Modes: Single pulse (diagnostic mapping), continuous pulse (functional testing/intraoperative monitoring)
Seizure Control: Ictal Disrupt function rapidly suppresses post-stimulation abnormal discharges
System Integration: Compatible with NicoletOne/NeuroWorks EEG; audit logs, auto-reporting, medical record annotation
Safety Monitoring: Real-time error detection, stimulation countdown, dual current display (set/actual)
Stand-alone/Integrated: Operates independently or synchronizes with EEG for closed-loop monitoring
三、产品特点 (Product Features)
中文
双相恒流输出：电荷平衡、无极化损伤，适配皮层 / 深部电极
可控：脉冲参数全量程可调，实际电流实时反馈，误差 < 5%
安全隔离：患者回路全浮地设计，漏电流极低，符合 BF 型医疗安全
紧凑便携：体积小巧（230×130×60mm）、重量 < 1kg，术中易移动
智能监护：Ictal Disrupt 自动抑制后放电，降低术中癫痫风险
兼容广泛：适配 Natus 一次性双极探针、颅内栅格 / 条状电极
操作便捷：旋钮 + 按键 + LCD 显示，参数一键设置，支持脚踏触发
English
Biphasic Constant Current: Charge-balanced, non-polarizing, safe for cortical/deep electrodes
Precise Control: Fully adjustable parameters, real-time current feedback, error <5%
Isolated Safety: Fully floating patient circuit, ultra-low leakage, Type BF compliant
Compact Portable: Small size (230×130×60mm), <1kg, easy OR maneuvering
Smart Protection: Ictal Disrupt auto-suppresses after-discharges, reduces seizure risk
Wide Compatibility: Works with Natus bipolar probes, intracranial grid/strip electrodes
User-friendly: Knob/button/LCD, one-touch setup, footswitch trigger support
四、技术参数 (Technical Specifications)
中文
刺激模式：单脉冲、连续脉冲（脉冲串）
输出类型：双相方波，恒流隔离输出
电流范围：0–15mA（1mA 步进），常规≤8mA
脉冲宽度：100–1000µs / 相（10µs 步进）
刺激频率：1–100Hz（0.1Hz 软件微调）
脉冲串时长：0.1–99.9s 可调
显示：LCD 屏（设定 / 实际电流、时间、参数、状态）
接口：串口（接 EEG）、刺激输出、脚踏开关
电源：AC 100–240V，15V/3A 适配器
尺寸 / 重量：230×130×60mm / <1kg
安全等级：BF 型应用部分，IPX0
English
Modes: Single pulse, continuous pulse train
Output: Biphasic square wave, isolated constant current
Current: 0–15mA (1mA steps), typical ≤8mA
Pulse Width: 100–1000µs/phase (10µs steps)
Frequency: 1–100Hz (0.1Hz software fine-tune)
Train Duration: 0.1–99.9s adjustable
Display: LCD (set/actual current, time, parameters, status)
Interfaces: Serial (EEG), stim output, footswitch
Power: AC 100–240V, 15V/3A adapter
Dimensions/Weight: 230×130×60mm / <1kg
Safety: Type BF applied part, IPX0
五、使用方法 (Usage)
中文
术前准备：开机自检；连接适配器、刺激电缆、脚踏开关；校准零点
参数设置：选模式（单脉冲 / 连续）；设电流（0→目标值）、脉宽、频率、串时长
电极连接：无菌下接颅内电极 / 双极探针；确认阻抗 < 5kΩ
刺激实施：患者监护；按脚踏 / 按键触发；观察反应 + 同步 EEG
功能定位：逐点刺激皮层，标记功能区；记录参数与反应
术中监护：连续模式监测；Ictal Disrupt 自动抑制异常放电
结束操作：电流归零→关机→清洁消毒探头 / 电缆→整理设备
English
Prep: Power-on self-test; connect adapter, cables, footswitch; zero calibration
Set Parameters: Select mode (single/continuous); set current (0→target), width, frequency, train duration
Electrode Setup: Sterile connection to intracranial electrodes/probe; confirm impedance <5kΩ
Stimulation: Monitor patient; trigger via footswitch/button; observe response + synchronized EEG
Mapping: Stimulate cortex point-by-point, label functional areas; log parameters/responses
OR Monitoring: Continuous mode; Ictal Disrupt auto-suppresses discharges
Completion: Reset current to 0 → power off → clean/disinfect → store
六、适应症 (Indications)
中文
脑肿瘤手术：术前 / 术中定位运动、语言、视觉中枢，保护功能区
癫痫外科：致痫灶定位、皮层刺激评估、后放电处理
功能神经外科：运动 / 感觉区 mapping、脑功能区病变手术
术中神经监护：颅脑 / 脊柱手术中实时监测皮层功能
神经诊断：难治性癫痫、脑外伤、脑血管病的功能评估
English
Brain Tumor Surgery: Pre/intra-op mapping of motor, speech, visual cortices to preserve function
Epilepsy Surgery: Epileptogenic focus localization, cortical assessment, after-discharge management
Functional Neurosurgery: Motor/sensory mapping, lesions in eloquent cortex
Intraoperative Monitoring: Real-time cortical function monitoring in cranial/spinal procedures
Neurological Diagnosis: Functional evaluation for refractory epilepsy, TBI, cerebrovascular disease
七、禁忌症 (Contraindications)
中文
绝对禁忌：
颅内金属异物（动脉瘤夹、弹片）、电子植入物（起搏器、DBS）
严重凝血障碍、颅内活动性出血、未控制的颅内感染
生命体征不稳定、昏迷 / 无法配合、严重心肺衰竭
相对禁忌：
癫痫频发、近期卒中 / 脑外伤、颅内高压（需评估）
孕妇、儿童（低强度慎用）
皮肤破损 / 感染（电极放置区）
English
Absolute:
Intracranial ｍmbedl (clips, shrapnel), electronic implants (pacemaker, DBS)
Severe coagulopathy, active intracranial bleeding, uncontrolled infection
Unstable vitals, coma, severe cardiopulmonary failure
Relative:
Frequent seizures, recent stroke/TBI, ICP (risk-assessed)
Pregnancy, pediatric (low-intensity caution)
Skin breakdown/infection at electrode sites
八、注意事项 (Precautions)
中文
安全：初始电流 0mA，缓慢递增；严禁超 15mA；全程监护 EEG / 生命体征
感染控制：探针 / 电缆无菌处理；一人一用一消毒；避免接触脑脊液
电磁干扰：远离高频电刀、MRI；屏蔽电缆；设备接地良好
操作：确认电极连接牢固；刺激区避开血管 / 血肿；异常立即停止
设备：定期校准；勿弯折电缆；防潮防尘；禁止拆机
人员：持证医师操作；熟悉癫痫急救；备急救药品 / 设备
English
Safety: Start at 0mA, gradual increase; never exceed 15mA; full EEG/vital monitoring
Infection Control: Sterile probes/cables; single-patient use; avoid CSF contact
EMI: Isolate from ESU/MRI; shielded cables; proper grounding
Operation: Secure connections; avoid vessels/hematomas; stop on abnormality
Equipment: Regular calibration; no cable kinking; moisture/dust proof; no disassembly
Personnel: Licensed operator; seizure first-aid trained; emergency meds/gear ready
九、存储条件 (Storage Conditions)
中文
环境：温度 10–30℃；湿度 30%–70%；无腐蚀、无尘、通风良好
防尘防潮：探头干燥密封；电缆盘绕松弛；光学 / 电子部件避光
长期存储：每 3 个月通电自检；适配器拔下；电池（如有）定期充电
运输：防震缓冲；温度 0–40℃；避免剧烈颠簸
English
Environment: 10–30°C, 30–70%RH, non-corrosive, dust-free, ventilated
Protection: Sealed dry probes; loose cable coiling; optics/electronics shielded from light
Long-Term: Power on self-test every 3 months; unplug adapter; battery maintenance
Transport: Shock-proof packaging; 0–40°C; avoid vibration
十、说明书核心信息 (Manual Core Info)
中文
注册信息：Natus Nicolet Cortical Stimulator，国械注进，神经外科刺激设备（II 类）
系统组成：刺激控制单元（SCU）、刺激切换单元（SSU）、电缆、一次性双极探针、适配器
维护：每日清洁；每周校准；年度预防性维护；软件更新
故障处理：
无输出→查电缆 / 连接 / 电流归零
电流误差→重新校准 / 换电极
报警→查错误代码 / 安全回路
保修：整机 1 年；耗材（探针 / 电极）3 个月；人为损坏除外
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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