厂家直供强生英特格拉颅内压监护仪826635
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厂家直供强生英特格拉颅内压监护仪826635
桂经理19117326863微xin同号
产品名称 颅内压监护仪Intracranial Pressure Monitor
管理类别 第三类
型号规格 见附页
结构及组成/主要组成成分 该产品由主机（监测仪）和缆线组成。
适用范围/预期用途 该产品能持续测量和显示颅内压波动的平均压。
一、工作原理 / Working Principle
中文
采用光导纤维（光纤）传感原理。配套的Codman MICROSENSOR微型光纤探头植入颅内（脑室、脑实质或硬膜下）后，颅内压力变化会使探头尖端的压力敏感膜片产生微小形变。该形变改变光纤内的反射光强度或相位，光信号经光纤传导至监护仪主机。主机通过光电转换、信号解调与算法计算，将光信号变化转换为颅内压（ICP）数值（平均压、收缩压、舒张压）及动态波形，实现实时、连续的压力监测。
English
Adopts the fiber-optic sensing principle. The 配套 Codman MICROSENSOR fiber-optic probe is implanted intracranially (intraventricular, parenchymal, or subdural). Intracranial pressure changes cause micro-deｆormation of the pressure-sensitive membrane at the probe tip. This deｆormation alters the intensity or phase of reflected light within the fiber, which is transmitted to the monitor. The host unit perｆorms photoelectric conversion, signal demodulation, and algorithmic calculation to convert optical signals into precise ICP values (mean, systolic, diastolic) and dynamic waveｆorms for real-time, continuous monitoring.
二、产品功能 / Functions
中文
核心监测：实时显示平均颅内压（mICP）、收缩压、舒张压及 ICP 动态波形。
多部位适配：支持脑室内、脑实质、硬膜下三种位点压力监测。
智能报警：可设平均 ICP 高低限报警，超限声光提醒。
一键调零：探头植入前 / 后一键快速校准，消除基线漂移。
数据输出：模拟信号输出，兼容医院中央监护系统，传输波形与数据。
趋势分析：记录并显示12–24 小时ICP 趋势，评估病情变化。
双供电模式：AC 市电 + 内置可充电电池，支持床旁与转运监护。
便捷接口：标准连接缆线（3m），适配 Codman 全系列 ICP 探头。
English
Core Monitoring: Real-time display of mean ICP, systolic, diastolic pressure, and dynamic ICP waveｆorms.
Multi-site Compatibility: Supports monitoring in intraventricular, parenchymal, subdural locations.
Smart Alarm: User-programmable high/low mean ICP alarms with audio-visual alerts.
One-touch Zeroing: Fast calibration before/after probe insertion to eliminate baseline drift.
Data Output: Analog signal output compatible with central patient monitors for waveｆorm/data transmission.
Trend Analysis: Records and displays 12–24 hour ICP trends for assessment.
Dual Power: AC power + internal rechargeable battery for bedside and transport use.
Easy Connection: Standard 3m cable compatible with full range of Codman ICP probes.
三、产品特点 / Product Features
中文
微创：光纤探头直径细、创伤小；测量精度高、响应快、抗电磁干扰。
操作极简：一键调零、大屏数字显示、界面直观，医护快速上手。
稳定可靠：探头零漂移设计，长期监测无需反复校准。
便携转运：机身轻巧、电池续航≥3 小时，适合 ICU / 急诊 / 转运场景。
安全设计：探头无菌一次性使用，防交叉感染；主机防水防摔。
临床适配广：兼容成人、儿童（>1 岁），适配颅脑损伤、出血、肿瘤等重症。
系统集成：标准信号输出，无缝接入医院中央监护与 EMR 系统。
English
Minimally Invasive & Accurate: Thin fiber-optic probe, minimal trauma; high precision, fast response, EMI-resistant.
Ultra-simple Operation: One-touch zeroing, large digital display, intuitive interface for quick mastery.
Stable & Reliable: Zero-drift probe design, no repeated calibration needed for long-term monitoring.
Portable for Transport: Lightweight, ≥3hr battery life; ideal for ICU/ER/transport.
Safe Design: Sterile, single-use probes prevent cross-infection; rugged, water-resistant casing.
Broad Clinical Use: For adults & children (>1yr); suitable for TBI, hemorrhage, tumor, etc..
System Integration: Standard output integrates seamlessly with central monitors & EMR.
四、技术参数 / Technical Parameters
表格
参数项 / Item 规格 / Specification
测量原理 光导纤维传感 / Fiber-optic Sensing
ICP 测量范围 0 ~ 100 mmHg (可扩展至 200 mmHg)
测量精度 ±1 mmHg (25 ~ 45℃)
显示参数 平均压、收缩压、舒张压、实时波形
报警范围 平均 ICP：0 ~ 100 mmHg 可调
探头适配 Codman MICROSENSOR (82-6631/6633/6653)
信号输出 0 ~ 100 mmHg 模拟电压
供电方式 AC 100~240V, 50/60Hz；内置电池 (续航≥3h)
工作温度 10 ~ 40℃
存储温度 -20 ~ 60℃
湿度 15 ~ 95% RH (无凝露)
尺寸 / 重量 140 × 85 × 55 mm / ~0.5 kg
防护等级 IPX1 (防滴水)
五、使用方法 / Operating Instructions
中文
术前准备
开机自检，确认电量 / 连接正常。
取出无菌 Codman 探头，检查包装完好。
一键调零：探头暴露于大气压下按 “ZERO” 校准。
探头植入
神经外科无菌操作，将探头植入脑室 / 脑实质 / 硬膜下位点。
牢固固定探头，连接监护仪专用缆线。
监测设置
设定报警阈值（常规上限 20 mmHg）。
确认实时 ICP 数值、波形稳定显示。
临床监测
连续记录 ICP 数据与趋势，观察报警。
指导脱水治疗、判断手术时机、评估预后。
终止与移除
病情稳定后，无菌移除探头，压迫止血。
清洁主机、消毒接口，关机存储。
English
Pre-op Preparation
Power on self-test; verify battery/connections.
Inspect sterile Codman probe packaging.
One-touch Zeroing: Press “ZERO” with probe open to air.
Probe Implantation
Sterile neurosurgical placement into ventricle/parenchyma/subdural space.
Secure probe; connect to monitor cable.
Monitoring Setup
Set alarm thresholds (standard upper limit: 20 mmHg).
Confirm stable ICP numeric & waveｆorm display.
Clinical Monitoring
Continuously record ICP data/trends; observe alarms.
Guide dehydration therapy, timing of surgery, prognosis.
Termination & Removal
Remove probe aseptically; apply pressure for hemostasis.
Clean unit, disinfect ports, power off & store.
六、适应症 / Indications
中文
重型颅脑损伤（GCS ≤ 8 分）：监测颅高压、指导治疗、判断预后。
脑出血 / 脑室出血：高血压脑出血、动脉瘤破裂出血，监测水肿与再出血。
大面积脑梗死：严重脑水肿、颅高压风险监测。
颅内肿瘤 / 脑积水：术前颅高压评估、术后监测、分流效果判断。
颅脑术后：开颅术后监测肿胀、出血、感染。
颅内感染：脑膜炎 / 脑炎伴严重脑水肿。
其他：中毒性脑病、肝性脑病、不明原因意识障碍伴颅高压。
English
Severe Traumatic Brain Injury (GCS ≤ 8): Monitor intracranial hypertension, guide therapy, assess prognosis.
Cerebral / Intraventricular Hemorrhage: Hypertensive hemorrhage, aneurysm rupture; monitor edema & rebleed.
Large Hemispheric Infarction: Monitor severe cerebral edema & ICP risk.
Intracranial Tumor / Hydrocephalus: Pre-op ICP assessment, post-op monitoring, shunt evaluation.
Post-neurosurgery: Monitor swelling, hemorrhage, infection after craniotomy.
Intracranial Infection: Meningitis/encephalitis with severe edema.
Others: Toxic/hepatic encephalopathy, unexplained coma with suspected HTN-ICP.
七、禁忌症 / Contraindications
中文
绝对禁忌
严重凝血功能障碍（DIC、血小板减少）：禁脑室 / 脑实质探头，防颅内出血。
头皮 / 颅骨感染、骨髓炎：植入路径感染风险高。
脑疝晚期、脑死亡：监测无临床意义。
患者不配合、无法耐受有创操作。
相对禁忌
凝血异常未纠正：可考虑硬膜外监测（风险较低）。
严重脑脊液漏：影响压力准确性。
颅底骨折伴脑脊液鼻漏 / 耳漏：增加感染风险。
English
Absolute Contraindications
Severe coagulopathy (DIC, thrombocytopenia): Contraindicated for intraventricular/parenchymal probes (risk of hemorrhage).
Scalp/skull infection, osteomyelitis: High infection risk at insertion site.
Advanced brain herniation, brain death: No clinical value.
Uncooperative patient, unable to tolerate invasive procedure.
Relative Contraindications
Uncorrected coagulopathy: May consider epidural monitoring (lower risk).
Severe CSF leakage: Impairs pressure accuracy.
Skull base fracture with CSF rhinorrhea/otorrhea: Increased infection risk.
八、注意事项 / Cautions
中文
专业操作：神经外科 / ICU经培训医师操作，严格无菌。
探头校准：植入前必须调零；植入后禁再调零，防数据失真。
感染防控：探头一次性无菌使用；每日换药，观察切口红肿渗液。
安全固定：探头 / 缆线牢固固定，防牵拉移位、脑组织损伤。
报警管理：报警立即核查，区分真性高压与探头故障。
电磁干扰：远离高频电刀、MRI 等强电磁设备，防信号干扰。
电池维护：转运前充满电；长期存储每月充电一次。
结果解读：ICP 结合临床表现、CT/MRI 综合判断，不单一依赖数值。
English
Professional Use: Only by trained neurosurgery/ICU staff; strict asepsis.
Probe Calibration: Must zero before implantation; no zeroing after insertion to avoid error.
Infection Control: Single-use sterile probe; daily dressing, check for redness/drainage.
Secure Fixation: Secure probe/cable to prevent dislodgement & brain injury.
Alarm Management: Investigate alarms immediately; distinguish true HTN from probe fault.
EMI Protection: Keep away from electrosurgical units, MRI to avoid interference.
Battery Care: Fully charge before transport; recharge monthly in storage.
Result Interpretation: Correlate ICP with clinical status & imaging; do not rely solely on numbers.
九、存储条件 / Storage Conditions
中文
环境：清洁、干燥、通风、无尘、无腐蚀性气体、无强电磁干扰。
温度：-20℃ ~ +60℃；避免阳光直射、高温 / 低温极端环境。
湿度：15% ~ 95% RH，无凝露；潮湿季需防潮。
放置：主机平稳固定，配件分类收纳；光学接口加盖防尘。
耗材：探头避光、无菌、冷藏（2~8℃），在有效期内使用。
维护：长期存储每月通电自检一次，保持电池活性。
English
Environment: Clean, dry, ventilated, dust-free, no corrosive gases, no strong EMI.
Temperature: -20°C ~ +60°C; protect from direct sunlight & extreme temps.
Humidity: 15% ~ 95% RH, no condensation; dehumidify in wet seasons.
Placement: Secure unit; organize accessories; cover optical ports to prevent dust.
Consumables: Store probes light-proof, sterile, refrigerated (2~8°C); use before expiry.
Maintenance: Power on self-test monthly during long storage to preserve battery.
十、说明书核心信息 / Manual Summary
中文
Codman 826635（ICP EXPRESS）是Integra/Codman生产的第二类有创颅内压监护仪，采用光纤传感技术，通过一次性微型探头监测脑室、脑实质、硬膜下压力。核心功能包括实时 ICP 数值 / 波形显示、声光报警、一键调零、数据输出、长时趋势。设备微创、高精度、零漂移、便携抗干扰，适用于重型颅脑损伤、脑出血、脑肿瘤等神经重症的颅高压监测。无菌植入、专业操作；禁用于凝血障碍、感染、脑死亡。需严格校准、防感染、抗干扰，定期维护以保障监测安全准确。
English
The Codman 826635 (ICP EXPRESS) is a Class II invasive ICP monitor by Integra/Codman, using fiber-optic sensing with a disposable microprobe for precise monitoring in ventricle, parenchyma, subdural spaces. Key features: real-time ICP values/waveｆorms, alarms, one-touch zero, data output, long-term trends. It is minimally invasive, high-precision, zero-drift, portable, EMI-resistant, intended for neurocritical care (severe TBI, hemorrhage, tumor). Requires sterile implantation & professional operation; contraindicated in coagulopathy, infection, brain death. Strict calibration, infection control, EMI protection, and maintenance ensure safe, accurate 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.
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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