厂家直供蓝莫德肝胆结石全息光谱分析仪LDR-P700
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厂家直供蓝莫德肝胆结石全息光谱分析仪LDR-P700
桂经理19117326863微xin同号
桂经理19117326863微xin同号
产品名称 肝胆结石全息光谱分析仪
管理类别 第二类
型号规格 LDR-P700
结构及组成/主要组成成分 本产品由主机、计算机软件（版本号：V1.0）、电源适配器组成。
适用范围/预期用途 适合于采用红外光谱分析法的人体肝胆系统结石成份的分析。
1、工作原理 Working Principle
中文：仪器采用傅里叶变换红外光谱检测原理，红外光源发射光束经干涉仪调制形成干涉光照射结石样本；不同化学成分的结石对特定波长红外光产生特征吸收，探测器采集透过样本的干涉光信号，经傅里叶数学变换得到红外光谱图；系统软件比对特征吸收峰，自动解析结石化学组分，为临床病因分析、预防提供实验室依据。本设备仅用于离体结石样本理化分析，不用于人体直接检测。
English：The instrument adopts Fourier‑transｆorm infrared spectroscopy principle. The infrared light beam emitted by infrared light source is modulated by interferometer into interference light and irradiates the gallstone sample. Stones of different chemical compositions produce characteristic absorption for infrared light of specific wavelengths. The detector collects interference light signals passing through samples, and obtains infrared spectrogram via Fourier transｆorm. System software identifies chemical components by analyzing characteristic absorption peaks, providing laboratory basis for clinical etiology research and recurrence prevention. It is only for in‑vitro stone sample analysis, not for direct human body testing.
2、功能 Function
中文
对离体人体肝胆结石样本进行红外光谱采集；
自动解析结石化学成分，输出组分报告；
光谱图谱存储、调取、预览；
报告编辑、预览、打印导出；
仪器自检、基线校正，数据归档管理。
English
Collect infrared spectrum of in‑vitro human hepatobiliary stone samples;
Automatically analyze stone chemical composition and output test report;
Store, recall and preview spectrogram;
Support report editing, preview, print and export;
Instrument self‑check, baseline correction and data archiving.
3、产品特点 Product Features
中文
专为肝胆结石样本分析设计，适配胆色素、胆固醇、混合型等肝胆类结石；
一体化光学结构，抗震动，光学部件免复杂调试；
软件 V1.0 版本，自动图谱解析，减少人工判读误差；
样品制备流程简洁，检测速度快；
整机集成度高，由主机、软件、电源适配器组成，便于实验室部署；
具备仪器状态诊断，可提示异常，保障检测可靠性。
English
Specially designed for hepatobiliary stone samples, applicable to pigment, cholesterol and mixed gallstones;
Integrated optical structure with anti‑vibration perｆormance, no complicated adjustment for optical components;
Software Version V1.0 with automatic spectrum analysis to reduce manual interpretation error;
Simple sample preparation and fast measurement;
High integration, composed of main unit, software and power adapter, easy for laboratory layout;
Built‑in instrument status diagnosis for abnormal alarm to ensure test reliability.
4、技术参数 Technical Parameters
中文
产品型号：LDR‑P700；注册证号：津械注准 20232070230
分析方式：傅里叶变换红外光谱法
软件版本：V1.0
工作电源：DC 电源，配套专用电源适配器
工作环境温度：10℃‑30℃；相对湿度：≤75%，无冷凝
光谱检测波段：红外中红外区
样品形式：离体固体肝胆结石（研磨制样）
组成：主机、计算机软件、电源适配器
整机类别：Ⅱ 类医疗器械
English
Model: LDR‑P700；Registration No.: Jin Xie Zhu Zhun 20232070230
Analysis Method: Fourier‑transｆorm infrared spectroscopy
Software Version: V1.0
Power Supply: DC with dedicated power adapter
Operating Ambient: Temperature 10℃‑30℃; relative humidity ≤75%, non‑condensing
Spectral Range: Mid‑infrared band
Sample Type: In‑vitro solid hepatobiliary stones (ground sample)
Components: Main unit, software, power adapter
Device Class: Class Ⅱ medical device
5、使用方法 Operation Method
中文
开机准备：放置仪器于平稳台面，连接电源适配器，开机，仪器预热完成后执行基线自检校正；
样品制备：取离体肝胆结石样本，清洁、干燥，研磨成细粉，按规范制备待测样品；
装样：将制备好样品放入样品测试位，关闭样品室；
检测：软件新建检测任务，录入样本信息，启动光谱扫描；
分析：扫描完成，软件自动解析结石组分，生成检测报告；
输出：预览、编辑报告，打印或导出电子报告；
结束测试：取出样品，清洁样品仓，正常关机，归档保存数据。
提示：必须使用离体结石标本，严禁对人体直接检测。
English
Preparation: Place instrument on stable bench, connect power adapter, power on. Perｆorm baseline self‑calibration after warm‑up.
Sample Preparation: Clean and dry in‑vitro hepatobiliary stone, grind into fine powder and prepare test sample according to specification.
Sample Loading: Place prepared sample at sample position and close sample compartment.
Measurement: Create new test task in software, input sample inｆormation and start spectrum scanning.
Analysis: After scanning, software automatically identifies stone components and generates test report.
Output: Preview, edit, print or export electronic report.
Shutdown: Take out sample, clean sample compartment, power‑off properly and archive data.
Note: Only in‑vitro stone specimen is allowed. Direct test on human body is prohibited.
6、适应症 Indications
中文：适用于医疗机构对人体离体肝胆系统结石样本，采用红外光谱法开展结石化学成分分析，辅助临床判断结石类型，为肝胆结石病因研究、治疗方案参考、结石风险评估提供依据。
English：For medical institutions to analyze chemical composition of in‑vitro human hepatobiliary stone samples by infrared spectroscopy. It assists clinicians in stone typing, supports etiology study, treatment reference and recurrence risk assessment of hepatobiliary stones.
7、禁忌症 Contraindications
中文
本设备仅检测离体结石，无人体直接检测适应症，禁止用于活体人体检测；
非肝胆来源结石样本不在本设备适用分析范围；
样品严重污染、受潮、碳化无法制样，不可检测。
English
The device is only for in‑vitro stone analysis. Direct testing on living human body is forbidden.
Stones not originated from hepatobiliary system are out of scope.
Severely contaminated, damp or carbonized samples which cannot be properly prepared shall not be tested.
8、注意事项 Notes
中文
仪器放置环境避免阳光直射、强电磁干扰、震动、粉尘；远离水源，防止受潮；
必须严格按照说明书进行样品制备，样品质量直接影响结果准确性；
定期做基线校准与仪器自检，光学窗口严禁手触摸，清洁使用指定耗材；
电源必须使用原厂配套适配器，禁止使用非适配电源；
仅可分析离体结石样本，不能直接用于人体诊断，检测结果需结合临床综合判读，不能单独作为诊断依据；
仪器操作人员应经培训，熟悉软件与操作流程；
样品、废弃物按医疗机构生物废弃物管理规范处置；
禁止自行拆解主机光学部件，维修保养由厂家授权人员执行。
English
Avoid direct sunlight, strong electromagnetic interference, vibration and dust. Keep away from water and moisture.
Follow sample‑preparation procedure strictly. Sample quality directly affects accuracy.
Perｆorm regular baseline calibration and self‑test. Do not touch optical window by hand, clean with designated consumables only.
Only use original matching power adapter; incompatible power supply is prohibited.
Only for in‑vitro stone samples. Test result should be interpreted combined with clinical inｆormation and shall not be used as sole diagnostic evidence.
Operators shall receive professional training.
Samples and waste shall be disposed according to hospital biological waste regulation.
Do not disassemble optical components. Maintenance must be perｆormed by manufacturer‑authorized personnel.
9、存储条件 Storage Condition
中文：仪器关机状态下存储；环境温度 5℃‑40℃，相对湿度≤80%，无冷凝；存放于干燥通风，无腐蚀性气体，无强震动、无强光直射的室内环境。长期闲置应断开电源适配器。
English：Store under power‑off status. Ambient temperature: 5℃‑40℃; relative humidity ≤80%, non‑condensing. Keep in dry, ventilated indoor environment without corrosive gas, heavy vibration or direct strong light. Disconnect power adapter for long‑term storage.
10、说明书核心摘要 Core Summary
中文：蓝莫德 LDR‑P700 肝胆结石全息光谱分析仪属于 Ⅱ 类医疗器械，注册证：津械注准 20232070230，由主机、V1.0 版本软件、电源适配器构成，利用傅里叶变换红外光谱法，对离体人体肝胆结石样本做化学成分检测，输出组分分析报告；仅用于离体样本理化检测，不能直接对人体检测；操作需要规范制样，结果需要结合临床综合判断；避免震动潮湿，定期校准，维护由厂家授权人员完成。
English：Lambdasci LDR‑P700 Hepatobiliary Stone Holographic Spectrum Analyzer is Class Ⅱ medical device, registration No. Jin Xie Zhu Zhun 20232070230. It consists of main unit, V1.0 software and power adapter. It adopts Fourier‑transｆorm infrared spectroscopy for chemical composition analysis on in‑vitro human hepatobiliary stone samples and outputs component report. It is for in‑vitro physical‑chemical analysis only and cannot test human body directly. Standardized sample preparation is required; results shall be interpreted with clinical inｆormation. Keep away from vibration and humidity, perｆorm regular calibration; maintenance shall be completed by manufacturer‑authorized staff。
免责声明：以上产品详情仅供参考，临床操作请以原厂纸质说明书为准。上海康世达医疗器械有限公司不生产医疗产品，所有产品均来自产品的生产厂家，代理商，经销商，如有侵权请联系我们，会尽快处理！The above product details are for reference only. All clinical operations shall be carried out in strict accordance with the original paper instructions for use issued by the manufacturer.
Shanghai Kangshida Medical Devices Co., Ltd. does not manufacture medical devices. All products are sourced from respective manufacturers, authorized agents and distributors.
Please contact us promptly in case of any infringement, and we will resolve the matter as soon as possible.
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