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上海康世达医疗器械有限公司 主营产品:医用体检,诊断,急救,化验,超声,医学分析,生命科学,消毒灭菌,康复治疗,手术室,急救室,诊疗室等设备,一类医疗器械,二类医疗器械,三类医疗器械,IVD及消毒器具耗材

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厂商直销意大利MIR米尔肺功能仪Spirobank Smart,Smart One

价格:¥ 电议

品牌名称:$brandModel.Title型号: 原产地:中国大陆 医疗器械注册号(批文):国械注进20212070314更新时间:2026/10/16 11:11:02

产品摘要:厂商直销意大利MIR米尔肺功能仪Spirobank Smart,Smart One

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心脏设备

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呼吸/麻醉设备

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详细内容

厂商直销意大利MIR米尔肺功能仪Spirobank Smart,Smart One

桂经理19117326863微xin同号

管理类别

第二类

型号规格

Spirobank Smart, Smart One

结构及组成/主要组成成分

该产品由主机、涡轮传感器组成。

适用范围/预期用途

产品适用于可配合完成指定呼吸动作的成人及儿童的肺活量测量。

一、工作原理(Working Principle)

中文

米尔肺功能仪采用双向数字涡轮流量传感器(FlowMIR?),通过涡轮旋转切割红外光束,将气流流速 / 流量转换为电信号,经内置温度 / 气压传感器自动 BTPS 校正(体温、气压、水汽饱和),积分运算得出肺活量、用力呼气量等容量参数。设备支持一次性预校准涡轮(免日常定标)或可重复使用金属涡轮(消毒后复用),数据可通过 USB / 蓝牙传输至 MIR Spiro 软件,实时生成流速容量环与质控报告。

English

The MIR spirometer adopts a bidirectional digital turbine flow sensor (FlowMIR?). The turbine rotates to block infrared light, converting airflow velocity/volume into electrical signals. Integrated temperature/barometric sensors perform automatic BTPS correction (body temperature, barometric pressure, water vapor saturation), and integral calculation generates volume parameters such as FVC and FEV1. The device supports disposable pre-calibrated turbines (no daily calibration needed) or reusable mmbedl turbines (disinfectable for reuse). Data can be transmitted via USB/Bluetooth to MIR Spiro software for real-time flow-volume loop generation and QC reporting.

二、产品功能(Functions)

中文

基础通气功能:FVC、FEV1、FEV1/FVC、PEF、FEF25%⁻⁷5%、MVV、SVC、VC、IVC、IC、ERV

特殊试验:支气管舒张 / 激发试验、肺年龄评估(ELA)、儿童激励测试

扩展功能:可选血氧模块(SpO2 / 脉率)、睡眠氧减分析(ODI)、运动试验、EMR/EHR 对接(HL7/FHIR)

数据

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.

管理:主机存储 6000–10000 份数据、多语言报告、USB / 蓝牙导出、流量 / 时间曲线实时显示

质控体系:红绿灯质控评级、呼吸动作引导、重复测试变异率判定

English

Basic Ventilation: FVC, FEV1, FEV1/FVC, PEF, FEF25%⁻⁷5%, MVV, SVC, VC, IVC, IC, ERV

Special Tests: Bronchodilator/provocation test, Estimated Lung Age (ELA), pediatric incentive test

Extended Features: Optional oximetry module (SpO2/heart rate), sleep oxygen reduction analysis (ODI), exercise test, EMR/EHR integration (HL7/FHIR)

Data Management: 6000–10000 test storage on host, multilingual reports, USB/Bluetooth export, real-time flow/time curve display

QC System: Traffic light QC rating, breathing guidance, repeat test variability assessment

三、产品特点(Features)

中文

双传感器可选:一次性 FlowMIR? 涡轮(预校准、一人一用、免消毒);可重复使用金属涡轮(耐用、可消毒)

全场景适配:台式(Spirolab III)/ 便携(Spirobank II)/ 手持(Minispir),覆盖医院、诊所、体检、家庭监测

免日常校准:一次性涡轮出厂预校准,可重复使用涡轮支持软件在线校准,无需每日操作

ATS/ERS 合规:精度符合国际标准,支持 GLI/ERS 预测值,适配全球人群

感染控制:一次性涡轮自带滤菌咬嘴,可搭配病毒 / 细菌过滤器,降低交叉感染

易用性:7 寸触控屏 / 中文界面、内置打印机、儿童动画引导、超长续航(40–100 小时)

数据安全:加密传输、软件升级免费、支持远程技术支持

English

Dual Sensor Options: Disposable FlowMIR? turbines (pre-calibrated, single-patient, no disinfection); reusable mmbedl turbines (durable, disinfectable)

Multi-scenario Adaptation: Desktop (Spirolab III)/portable (Spirobank II)/handheld (Minispir) for hospitals, clinics, physical exams, and home monitoring

No Daily Calibration: Disposable turbines are factory-calibrated; reusable turbines support software-based online calibration

ATS/ERS Compliant: Accuracy meets international standards; supports GLI/ERS predicted values for global populations

Infection Control: Disposable turbines with integrated filter mouthpieces; compatible with viral/bacterial filters to reduce cross-contamination

User-friendly: 7-inch touchscreen/Chinese interface, built-in printer, pediatric animation guidance, long battery life (40–100 hours)

Data Security: Encrypted transmission, free software upgrades, remote technical support






四、技术参数(Technical Specifications)

表格

参数项(Parameter) 中文(Chinese) 英文(English)

流量传感器(Flow Sensor) 双向数字涡轮(FlowMIR?) Bidirectional digital turbine (FlowMIR?)

流量范围(Flow Range) ±16 L/s ±16 L/s

流量精度(Flow Accuracy) ±5% 或 ±200 mL/s(取大) ±5% or ±200 mL/s (whichever greater)

容量范围(Volume Range) 0–10 L 0–10 L

容量精度(Volume Accuracy) ±2.5% 或 ±50 mL(取大) ±2.5% or ±50 mL (whichever greater)

动态阻力(Dynamic Resistance) <0.5 cmH?O/L/s(12 L/s) <0.5 cmH?O/L/s at 12 L/s

采样率(Sample Rate) 100 Hz 100 Hz

连接方式(Connectivity) USB 2.0 / 蓝牙(可选) USB 2.0/Bluetooth (optional)

显示(Display) 7 寸彩色触控屏(320×240 像素) 7-inch color touchscreen (320×240 pixels)

存储(Storage) 6000–10000 份测试数据 6000–10000 test records

电源(Power) 可充电锂电池 + AC 100–240V Rechargeable Li-ion battery + AC 100–240V

尺寸 / 重量(Dimensions/Weight) 台式:220×210×51 mm/1.45 kg;手持:142×49.7×26 mm/65 g Desktop: 220×210×51 mm/1.45 kg; Handheld: 142×49.7×26 mm/65 g

工作环境(Operating Temp/Humidity) 10–40℃,15–90% RH(无冷凝) 10–40℃, 15–90%RH (non-condensing)

存储环境(Storage Temp/Humidity) -20–50℃,10–95% RH(无冷凝) -20–50℃, 10–95%RH (non-condensing)

五、使用方法(Operation)

中文

准备

开机自检,选择语言 / 患者信息(年龄、身高、体重、性别),选择测试模式(FVC/VC/MVV/ 舒张试验)

患者坐位,夹鼻夹,含一次性咬嘴,确保口唇密封

示范动作:平静呼吸→最大吸气→快速呼气≥6 秒→最大吸气

核心测试

FVC:平静呼吸 3 次→最大深吸气→最快最用力呼气至完全排空→快速吸气,重复 2–3 次,取变异率 < 5% 的最佳值

MVV:指令最快最深呼吸 12 秒,自动计算 1 分钟最大通气量

舒张试验:按软件梯度给药,对比用药前后 FEV1/FVC 变化

结束

自动生成报告(含流量容量环、质控评级),可打印 / 导出

一次性咬嘴丢弃,可重复使用涡轮用专用消毒液消毒

English

Preparation

Power on self-test, select language/patient data (age, height, weight, gender), and choose test mode (FVC/VC/MVV/bronchodilator test)

Patient seated, nose clip applied, disposable mouthpiece sealed with lips

Demonstrate: Quiet breathing → max inspiration → forceful fast expiration ≥6s → max inspiration

Core Tests

FVC: 3 quiet breaths → max deep inspiration → fastest/forceful exhalation to full empty → rapid inspiration; repeat 2–3 times, accept best with variability <5%

MVV: Breathe fastest/deepest for 12 seconds; auto-calculate 1-minute max ventilation

Bronchodilator test: Administer drugs gradiently per software; compare pre/post FEV1/FVC changes

Finish

Auto-generate report (with flow-volume loop, QC rating); printable/exportable

Dispose of disposable mouthpieces; disinfect reusable turbines with special solution

六、适应症(Indications)

中文

哮喘、COPD 的诊断、分级、长期监测

咳嗽、胸闷、气短、喘息的病因筛查

胸腹部手术术前肺功能风险评估

肺纤维化、间质性肺病、尘肺病的诊断与随访

支气管舒张 / 激发试验,鉴别气道高反应性

长期吸烟、粉尘暴露者肺功能普查

4 岁以上儿童及成人肺功能评估、临床研究

English

Diagnosis, staging, long-term monitoring of asthma and COPD

Etiology screening for cough, chest tightness, dyspnea, wheezing

Preoperative pulmonary risk assessment for thoracic/abdominal surgery

Diagnosis and follow-up of pulmonary fibrosis, interstitial lung disease, pneumoconiosis

Bronchial provocation/dilation tests to identify airway hyperresponsiveness

Pulmonary function screening for long-term smokers and dust-exposed workers

Pulmonary function assessment for children ≥4 years and adults; clinical trials

七、禁忌症(Contraindications)

中文

绝对禁忌

近 3 个月心肌梗死、脑卒中、休克

近 4 周不稳定心绞痛、严重心力衰竭

未控制高血压(SBP>200/DBP>100 mmHg)

活动性气胸、巨大肺大疱(未手术)

近 1 个月大咯血、眼部 / 胸腹手术

癫痫发作期、严重认知障碍无法配合

相对禁忌

心率 > 120 次 / 分、严重心律失常

妊娠晚期、鼓膜穿孔

近 4 周急性呼吸道感染

严重呼吸困难、晕厥史、无法耐受用力呼吸

English

Absolute Contraindications

Recent myocardial infarction, stroke, shock (within 3 months)

Recent unstable angina, severe heart failure (within 4 weeks)

Uncontrolled hypertension (SBP>200/DBP>100 mmHg)

Active pneumothorax, large bullae (untreated)

Recent massive hemoptysis, eye/thoracic/abdominal surgery (within 1 month)

Active epilepsy, severe cognitive impairment unable to cooperate

Relative Contraindications

HR>120 bpm, severe arrhythmia

Late pregnancy, tympanic membrane perforation

Recent acute respiratory infection (within 4 weeks)

Severe dyspnea, syncope history, unable to tolerate forced breathing

八、注意事项(Precautions)

中文

测试前停药:短效支气管扩张剂停 12 小时,停 24–48 小时(遵医嘱)

测试前 1 小时禁剧烈运动、吸烟、咖啡 / 浓茶、大量进食

环境温度20–25℃,避免气流直吹、电磁干扰

确保咬嘴密封、鼻夹夹紧,防止漏气导致数据偏差

严重患者缩短测试时长,出现头晕、胸闷立即停止

一次性咬嘴一人一换,可重复使用涡轮每次用后消毒 15 分钟

设备防摔、防水、防尘,专人操作维护

测试结果需结合临床症状、影像学综合判断

English

Medication withdrawal before test: Short-acting bronchodilators for 12 hours; long-acting for 24–48 hours (per physician)

No strenuous exercise, smoking, coffee/strong tea, heavy meal 1 hour before the test

Room temperature 20–25℃, avoid direct airflow and electromagnetic interference

Ensure tight mouthpiece seal & nose clip to prevent data deviation from leaks

Shorten test duration for severe patients; stop immediately if dizziness, chest tightness occurs

Disposable mouthpieces for single patient use; disinfect reusable turbines for 15 minutes after each use

Protect the device from drops, water, dust; operated by trained staff

Test results need comprehensive judgment with clinical symptoms and imaging

九、存储条件(Storage Conditions)

中文

温度:-20℃ ~ +50℃

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:厂商直销意大利MIR米尔肺功能仪Spirobank,SmartSmart,One,米尔肺功能仪,MIR肺功能仪

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