厂家直供以色列PulmOne帕慕肺功能仪MiniBox+
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厂家直供以色列PulmOne帕慕肺功能仪MiniBox+
桂经理19117326863微xin同号
管理类别
第二类
型号规格
MiniBox+
结构及组成/主要组成成分
由主机（含控制单元、手持单元）、3L校准注射器、校准过滤器和一氧化碳弥散量（DLCO）供气管组成。
适用范围/预期用途
该产品在医疗机构中用于测量 5 岁及以 上患者的肺通气参数。
产品储存条件及有效期
一、工作原理（Working Principle）
中文
MiniBox + 采用双向数字流量传感器与非色散红外气体分析技术，通过部分容量法（PVM） 与软件积分运算，检测呼吸气流的流速、容量及气体浓度。设备无需传统体描箱，通过呼吸力学与气体扩散分析，自动完成BTPS 修正与质控，同步测定通气功能、肺容量与弥散功能（DLCO）PulmOne。
English
MiniBox+ utilizes bidirectional digital flow sensor and non-dispersive infrared (NDIR) gas analysis, adopting Partial Volume Method (PVM) and software integration to accurately measure respiratory flow, volume, and gas concentration. It eliminates the traditional body box, automatically perｆorms BTPS correction and quality control, and simultaneously tests ventilation, lung volumes, and diffusion capacity (DLCO)PulmOne.
二、产品功能（Functions）
中文
通气功能：FVC、FEV1、FEV1/FVC、PEF、FEF25%⁻⁷5%、MVV、SVC、VCPulmOne
肺容量（无舱）：TLC、RV、FRC、ERV、IC（部分容量法 PVM）PulmOne
弥散功能：单次呼吸法 DLCO、VA、KCO、校正值PulmOne
支气管试验：舒张 / 激发试验、用药前后对比PulmOne
呼吸肌力：MIP、MEP、P0.1
数据管理：自动报告、Z 评分 / LLN、质控评级、数据导出（PDF/USB）PulmOne
自动质控：自校准、BTPS 修正、ATS/ERS 标准判断
English
Ventilation: FVC, FEV1, FEV1/FVC, PEF, FEF25%⁻⁷5%, MVV, SVC, VCPulmOne
Cabinless Lung Volumes: TLC, RV, FRC, ERV, IC (Partial Volume Method)PulmOne
Diffusion: Single-breath DLCO, VA, KCO, corrected valuesPulmOne
Bronchial Tests: Dilator/Challenge, pre/post comparisonPulmOne
Respiratory Muscle Strength: MIP, MEP, P0.1
Data Management: Auto-report, Z-score/LLN, QC rating, export (PDF/USB)PulmOne
Auto QC: Self-calibration, BTPS correction, ATS/ERS compliance
三、产品特点（Features）
中文
无舱式设计：替代传统体描箱，占地小、患者舒适、5 岁以上适用
全自动检测：一键操作、自动质控、自动报告，15-20 分钟完成全 PFT
自校准系统：无需每日手动定标，精度稳定
高精度传感：流量 ±2.5%、容量 ±2%、弥散 ±1%，符合 ATS/ERSPulmOne
一体化检测：通气 + 容量 + 弥散三合一，无需多设备PulmOne
高清触控屏：10.8 英寸 Full HD，中文界面、操作直观
便携紧凑：体积 51×47×31cm，重 8kg，可移动使用PulmOne
高效过滤：99.99% 滤菌膜，防交叉感染
多参数报告：含预测值、实测值、Z 评分、LLN、图形曲线PulmOne
English
Cabinless Design: Replaces body box, compact, patient-friendly, for age ≥5
Fully Automatic: One-key operation, auto-QC, auto-report, full PFT in 15-20 min
Self-calibrating: No daily manual calibration, stable accuracy
High Precision: Flow ±2.5%, Volume ±2%, Diffusion ±1%, ATS/ERS compliantPulmOne
All-in-One: Ventilation + Volumes + Diffusion in single devicePulmOne
Full HD Touchscreen: 10.8-inch, Chinese interface, intuitive
Portable: 51×47×31cm, 8kg, mobile usePulmOne
High-efficiency Filter: 99.99% bacterial filtration
Comprehensive Report: Predicted, measured, Z-score, LLN, graphsPulmOne
四、技术参数（Technical Specifications）
中文
流量范围：±14 L/s（双向）
流量精度：±2.5% 或 0.05 L/s（取大）PulmOne
容量范围：0~30 LPulmOne
容量精度：±2%PulmOne
弥散分析：NDIR 红外，CO/CH? 0~0.35%，响应 < 85msPulmOne
采样率：2 kHzPulmOne
死腔量：手持单元 50 mL，主管 130 mLPulmOne
显示：10.8 英寸 Full HD 触控屏
电源：AC 100~240V，50/60Hz
尺寸 / 重量：510×470×310 mm / 8 kgPulmOne
工作环境：10~40℃，15~90% RH（无冷凝）
存储环境：-20~50℃，10~95% RH（无冷凝）
English
Flow Range: ±14 L/s (bidirectional)
Flow Accuracy: ±2.5% or 0.05 L/s (whichever greater)PulmOne
Volume Range: 0~30 LPulmOne
Volume Accuracy: ±2%PulmOne
Diffusion: NDIR, CO/CH? 0~0.35%, response <85msPulmOne
Sample Rate: 2 kHzPulmOne
Dead Space: HHU 50 mL, Manifold 130 mLPulmOne
Display: 10.8-inch Full HD touchscreen
Power: AC 100~240V, 50/60Hz
Dimensions/Weight: 510×470×310 mm / 8 kgPulmOne
Operating: 10~40℃, 15~90%RH (non-condensing)
Storage: -20~50℃, 10~95%RH (non-condensing)
五、使用方法（Operation）
中文
准备
开机自检、自动校准
录入患者信息（年龄、身高、体重、种族）
患者坐位，夹鼻夹，含一次性咬嘴
通气测试（FVC）
平静呼吸→最大吸气→呼气≥6 秒→最大吸气
重复 2~3 次，取最佳值（变异 < 5%）
肺容量（PVM）
平静潮式呼吸 60 秒，自动计算 FRC、TLC、RV
弥散（DLCO）
呼气至 RV→吸气含测试气体→屏气 10 秒→呼气PulmOne
结束
自动生成报告、存储 / 打印
消毒咬嘴与传感器表面
English
Preparation
Power on, self-test & auto-calibration
Enter patient data (age, height, weight, ethnicity)
Patient seated, nose clip, disposable mouthpiece
Ventilation (FVC)
Quiet breath → max inhale → forceful exhale ≥6s → max inhale
Repeat 2–3 times, accept best (variability <5%)
Lung Volume (PVM)
Tidal breathing for 60s; auto-calculate FRC, TLC, RV
Diffusion (DLCO)
Exhale to RV → inhale test gas → hold 10s → forceful exhalePulmOne
Finish
Auto-report, save/print
Disinfect mouthpiece & sensor surface
六、适应症（Indications）
中文
COPD、哮喘的诊断、分级、监测PulmOne
咳嗽、气短、胸闷病因筛查PulmOne
术前肺功能评估（胸 / 腹部手术）PulmOne
肺纤维化、间质性肺病、尘肺诊断随访PulmOne
支气管舒张 / 激发试验（鉴别气道高反应）PulmOne
吸烟、粉尘暴露者肺功能普查PulmOne
5 岁以上儿童及成人肺功能评估
药物疗效评价（慢阻肺、哮喘、ILD）PulmOne
English
Diagnosis, staging, monitoring of COPD, asthmaPulmOne
Etiology screening for cough, dyspnea, chest tightnessPulmOne
Preoperative evaluation (thoracic/abdominal surgery)PulmOne
Diagnosis/follow-up of fibrosis, ILD, pneumoconiosisPulmOne
Bronchial tests (identify hyperresponsiveness)PulmOne
Screening for smokers, dust-exposed workersPulmOne
Assessment for adults & children ≥5 years
Treatment efficacy (COPD, asthma, ILD)PulmOne
七、禁忌症（Contraindications）
中文
绝对禁忌
近 3 个月心梗、脑卒中、休克
近 4 周严重心衰、不稳定心绞痛
未控制高血压（SBP>200/DBP>100）
活动性气胸、巨大肺大疱
主动脉瘤、严重甲亢
大咯血、近期眼部 / 胸腹手术
癫痫发作期、无法配合
相对禁忌
心率 > 120 次 / 分
妊娠晚期、鼓膜穿孔
近 4 周呼吸道感染
严重呼吸困难、晕厥史
English
Absolute
Recent MI, stroke, shock (3 months)
Severe heart failure, unstable angina (4 weeks)
Uncontrolled HTN (SBP>200/DBP>100)
Active pneumothorax, large bullae
Aortic aneurysm, severe hyperthyroidism
Massive hemoptysis, recent eye/thoracic/abdominal surgery
Active epilepsy, unable to cooperate
Relative
HR >120 bpm
Late pregnancy, tympanic membrane perforation
Recent respiratory infection (4 weeks)
Severe dyspnea, syncope history
八、注意事项（Precautions）
中文
测试前停药：短效支扩剂 12h， 24~48h（遵医嘱）
测试前 1h禁运动、吸烟、咖啡、浓茶
环境20~25℃，无气流直吹
确保咬嘴密封、鼻夹夹紧
严重患者缩短测试，防头晕、气促加重
一次性咬嘴一人一换，表面消毒
设备防摔、防水、防尘，专人操作
结果结合临床综合判断
English
Withhold meds: Short-acting 12h, long-acting 24–48h (per MD)
No exercise, smoking, coffee, tea 1h before
Room temp 20–25℃, no drafts
Ensure tight seal & nose clip
Shorten test for severe patients; avoid syncope
Disposable mouthpieces; surface disinfection
Protect from drops/water/dust; trained staff only
Correlate results with clinical findings
九、存储条件（Storage Conditions）
中文
温度：-20℃ ~ +50℃
湿度：10% ~ 95%（无冷凝）
避免阳光直射、潮湿、粉尘、腐蚀气体、强电磁
传感器、咬嘴干燥密封存放
长期存储：保持电量，定期自检
配件、说明书分类保管
English
Temp: -20°C to +50°C
Humidity: 10–95% (non-condensing)
Avoid sunlight, moisture, dust, corrosive gases, strong EMI
Store sensors/mouthpieces dry & sealed
Long-term: Maintain charge, periodic self-test
Keep accessories/manuals organized
十、说明书核心信息（Manual Core Summary）
中文
名称：MiniBox+ 无舱式肺功能仪（PulmOne）
原理：流量传感 + 红外气体分析 + 部分容量法（PVM）PulmOne
功能：通气 + 容量 + 弥散 + 支气管试验 + 肌力PulmOne
标准：符合ATS/ERS国际规范PulmOne
适用：5 岁以上可配合患者
安全：Ⅱ 类医疗器械，、无辐射、高滤过
校准：全自动自校准，无需每日手动
测试：全自动化，15~20 分钟完成全 PFT
报告：30 + 参数、Z 评分、LLN、图形、质控评级PulmOne
维护：表面清洁、耗材更换、定期自检
保修：原厂 1 年保修，终身技术支持
English
Name: MiniBox+ Cabinless Spirometer (PulmOne)
Principle: Flow sensing + NDIR gas analysis + PVMPulmOne
Functions: Ventilation + Volumes + Diffusion + Bronchial Tests + Muscle StrengthPulmOne
Standards: ATS/ERS compliantPulmOne
Application: Patients ≥5 years cooperative
Safety: Class II, non-invasive, radiation-free, high filtration
Calibration: Fully automatic self-calibration
Testing: Fully automated, full PFT in 15–20 min
Report: 30+ parameters, Z-score, LLN, graphs, QCPulmOne
Maintenance: Surface cleaning, consumables, self-test
Warranty: 1-year factory warranty, lifetime support
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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