厂家直供爱凯回弹式眼压计TA031,IC200
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厂家直供爱凯回弹式眼压计TA031,IC200
桂经理19117326863微xin同号
第二类
型号规格
TA031
结构及组成/主要组成成分
该产品由主机和一次性使用探头(TP022)组成。
适用范围/预期用途
该产品用于眼内压的测量，在医疗机构使用。也可与本公司生产的一次性使用探针(TP01)配合使用。
回弹式眼压计 TA031 (iCare IC200) 中英文核心资料
一、工作原理 (Working Principle)
中文采用专利回弹式测量技术。将一次性磁化探针装入设备后，内部螺线管瞬时通电产生磁场，驱动探针以约 0.2m/s的低速轻触角膜。探针撞击角膜后减速并回弹，系统通过传感器精确监测探针的减速度与回弹时间，依据牛顿力学原理计算眼压：眼压越高，探针回弹速度越快、时间越短。全程无需表面麻醉，仅微秒级接触，。EnglishUtilizes patented rebound measurement technology. A disposable, magnetized probe is propelled by a brief magnetic pulse from the internal solenoid toward the cornea at a low speed of ~0.2 m/s. Upon contact, the probe decelerates and rebounds. Sensors precisely measure the deceleration and rebound time, and the IOP is calculated based on Newtonian mechanics: higher IOP results in faster probe rebound and shorter contact time. No topical anesthesia is required; contact is micro-seconds, non-invasive and painless.
二、产品功能 (Functions)
中文
多体位测量：支持200° 测量，适配坐位、站立位、仰卧位、侧卧位，适用于手术室、急诊、卧床患者
双测量模式
标准模式：自动完成6 次连续测量，计算均值，结果稳定可靠
快速模式 (Quick Measure)：单次快速测量，高效筛查
智能辅助系统：红绿指示灯提示对齐状态，确保探针垂直对准角膜中心
数据管理：自动存储测量记录，支持患者 ID / 眼别 (OD/OS) 标记，可检索、追溯
无线数据传输：内置蓝牙，支持连接无线打印机或电脑，数据导出、打印
安全防感染：一次性无菌探针（伽马消毒），杜绝交叉感染
无需麻醉 / 无喷气：舒适，适配儿童、老人、敏感人群
English
Multi-Position Measurement: 200° full orientation freedom; measures in sitting, standing, supine, or lateral positions—ideal for OR, ER, and bedridden patients
Dual Measurement Modes
Standard Mode: Auto 6 consecutive readings, averages for stable, reliable results
Quick Measure: Single rapid reading for efficient screening
Smart Alignment Aid: Red/green LED indicators ensure perpendicular alignment to corneal center
Data Management: Auto-saves measurements; tags with Patient ID/eye (OD/OS) for recall & tracking
Wireless Connectivity: Built-in Bluetooth for wireless printing & PC data export
Infection Control: Sterile single-use probes (gamma-irradiated) eliminate cross-contamination
Anesthesia/Air-Puff Free: Non-invasive, comfortable for children, elderly, sensitive patients
三、产品特点 (Product Features)
中文
旗舰级多体位：200° 旋转测量，临床适用性远超传统手持眼压计
高清彩屏：1.44 英寸彩色 LCD，界面直观，强光下可读
便携：重165g（不含电池）/260g（含电池），单手操作，口袋便携
免校准：开机自检，无需日常校准，即开即用
人体工学：防滑握柄、前额支撑、腕带，长时间操作稳定舒适
高效省电：4 节 AA 碱性电池，可测 **≥1000 次 **，低电量提醒
原装探针专用：仅适配iCare 原装 TP02 系列探针，精度与安全保障
临床权威：与 Goldmann 压平眼压计（GAT）高一致性，符合 ISO 标准
English
Flagship Versatility: 200° rotational range; unmatched clinical adaptability vs. traditional handheld tonometers
Vivid Color Display: 1.44” color LCD; intuitive UI, readable in bright light
Ultra-Portable: 165g (without batteries)/260g (with batteries); one-handed, pocket-sized
Calibration-Free: Self-calibrates on startup; no daily calibration required
Ergonomic Design: Non-slip grip, forehead rest, wrist strap; stable & comfortable for prolonged use
Long Battery Life: 4×AA alkaline; ≥1000 measurements; low-battery alert
Genuine Probe Exclusive: Works only with iCare TP02 probes; guaranteed accuracy & safety
Clinically Validated: High agreement with Goldmann Applanation Tonometry (GAT); ISO-compliant
四、技术参数 (Technical Specifications)
表格
参数项 (Item) 中文 (Chinese) 英文 (English)
型号 (Model) TA031 (iCare IC200) TA031 (iCare IC200)
测量原理 (Principle) 回弹式 (感应回弹技术) Rebound (Inductive rebound technology)
测量范围 (Range) 7–50 mmHg (显示 0–99 mmHg) 7–50 mmHg (Display: 0–99 mmHg)
测量精度 (Accuracy) ≤20 mmHg：±1.2 mmHg；＞20 mmHg：±2.2 mmHg ≤20 mmHg: ±1.2 mmHg; >20 mmHg: ±2.2 mmHg
重复性 (Repeatability) 变异系数＜8% Coefficient of variation <8%
显示分辨率 (Resolution) 0.1 mmHg 0.1 mmHg
测量角度 (Angle) 0°–90° (200° 范围) 0°–90° (200° range)
探针 (Probe) 一次性无菌 (TP02), 直径 1.8mm, 重 26.5mg Single-use sterile (TP02), Ø1.8mm, 26.5mg
尺寸 (Dimensions) 43×104×214 mm (宽 × 高 × 长) 43×104×214 mm (W×H×L)
重量 (Weight) 165g (无电池); 260g (含 4×AA) 165g (w/o battery); 260g (w/4×AA)
电源 (Power) 4×AA 碱性电池 (LR6) 4×AA Alkaline (LR6)
电池寿命 (Battery Life) ≥1000 次测量 ≥1000 measurements
显示屏 (Display) 1.44 英寸彩色 LCD 1.44” Color LCD
无线 (Connectivity) Bluetooth (经典 / 低功耗 BLE) Bluetooth Classic/BLE
操作环境 (Operating) +10℃～+35℃, 30%–90%RH, 800–1060hPa +10°C to +35°C, 30–90%RH, 800–1060hPa
存储环境 (Storage) -10℃～+55℃, 10%–95%RH, 700–1060hPa -10°C to +55°C, 10–95%RH, 700–1060hPa
认证 (Certifications) CE, FDA, NMPA, ISO 13485 CE, FDA, NMPA, ISO 13485
五、使用方法 (Instructions for Use)
中文
准备
装 4 节 AA 电池，开机，等待自检完成。
拉出前额支撑至最长；装入一次性无菌探针，自动磁化。
患者取舒适体位（坐 / 卧 / 站），双眼平视前方。
对齐
设备贴紧前额，探针距角膜约 5mm，垂直对准中心。
绿灯亮 =对齐正确；红灯亮 = 角度错误，调整。
测量
标准模式：按测量键，自动完成 6 次测量，显示平均值。
快速模式：选 Quick Measure，一键单次测量。
可用导航键标记眼别 (OD/OS) 或患者 ID。
结束
记录 / 打印 / 蓝牙导出数据。
丢弃探针，关机，清洁设备。
English
Preparation
Insert 4×AA batteries, power on, wait for self-test.
Extend forehead support fully; load sterile single-use probe (auto-magnetizes).
Position patient comfortably (sit/supine/stand); eyes fixate forward.
Alignment
Rest device on forehead; probe ~5mm from cornea, perpendicular to center.
Green LED: Good alignment; Red LED: Incorrect angle—adjust.
Measurement
Standard Mode: Press measure; auto 6 readings, displays average.
Quick Measure: Select mode, single-button reading.
Tag with eye (OD/OS) or Patient ID via navigation buttons.
Completion
Record/print/Bluetooth export data.
Discard probe, power off, clean device.
六、适应症 (Indications)
中文
青光眼筛查、诊断与监测：成人 / 儿童 / 高危人群（家族史、糖尿病、高度近视）基础与随访眼压测量
多体位临床测量：手术室、ICU、急诊、卧床 / 术后患者仰卧 / 侧卧位眼压评估
眼科常规体检：门诊、社区、体检中心快速大规模筛查
屈光 / 白内障术前评估：排除高眼压症、青光眼，确保手术安全
特殊人群：儿童、老年人、痴呆、精神障碍、无法配合传统检查者
角膜异常患者：角膜水肿、混浊、瘢痕、屈光术后（优于非接触式）
术后监测：青光眼、白内障、玻璃体术后动态眼压监测
English
Glaucoma Screening/Diagnosis/Monitoring: Baseline & follow-up IOP for adults/children/at-risk groups (family history, diabetes, high myopia)
Multi-Position Clinical Use: OR, ICU, ER, bedridden/post-op patients—supine/lateral IOP assessment
Routine Ocular Exams: Clinic, community, health screenings—rapid mass testing
Pre-Surgical Evaluation: Refractive/cataract surgery; rule out OHT/glaucoma for safety
Special Populations: Children, elderly, dementia, psychiatric, uncooperative for traditional exams
Corneal Abnormalities: Edema, opacity, scars, post-refractive surgery (superior to NCT)
Post-Op Monitoring: Non-invasive IOP tracking post-glaucoma/cataract/vitrectomy
七、禁忌症 (Contraindications)
中文
绝对禁忌
眼球破裂、开放性眼外伤、眼内容物脱出（严禁接触）
角膜大面积穿孔、活动性眼内炎（感染扩散风险）
无法控制的眼球震颤、严重眼睑痉挛（无法稳定测量）
急性化脓性结膜炎 / 角膜炎（强传染性）
相对禁忌（谨慎）
角膜极薄（＜500µm）或极厚（＞600µm），结果可能偏差
眼压＞50mmHg（建议用压平眼压计复核）
眼表化学 / 热烧伤急性期（避免刺激）
近期眼部手术 / 外伤，创面未愈合
English
Absolute Contraindications
Ruptured globe, open trauma, intraocular content prolapse (NO contact)
Large corneal perforation, acute endophthalmitis (infection risk)
Uncontrollable nystagmus, severe blepharospasm (unstable measurement)
Acute purulent conjunctivitis/keratitis (highly contagious)
Relative Contraindications (Caution)
Extremely thin/thick cornea (<500µm/>600µm); results may be biased
IOP >50mmHg (confirm with GAT)
Acute chemical/thermal burn (avoid irritation)
Recent eye surgery/trauma with unhealed wounds
八、注意事项 (Precautions)
中文
人员资质：眼科 / 医护专业人员操作，需培训合格
探针管理：仅用 iCare 原装 TP02 无菌探针，禁止重复使用 / 触碰针尖
对齐关键：必须垂直对准角膜中心，倾斜 / 偏移致误差；依赖绿灯提示
患者配合：测量时禁挤眼、转头、说话；儿童需辅助固定头部
清洁消毒：机身 / 前额支撑用70% 异丙醇擦拭；严禁酒精接触光学 / 探针座
磁场干扰：远离强磁场（手机、磁铁），避免影响测量
电池维护：长期不用取出电池，防漏液损坏
结果判读：以6 次均值为准；波动大时显示 “Repeat”，需重测
感染控制：传染性眼病检查，消毒
English
Personnel: For trained ophthalmic/medical staff only
Probe Use: Only genuine iCare TP02 sterile probes; no reuse/touching tip
Alignment Critical: Must be perpendicular to corneal center; tilt/offset causes error—follow green LED
Patient Compliance: No squeezing/movement/talking; pediatric restraint required
Cleaning: Wipe body/forehead rest with 70% isopropyl; NO alcohol on optics/probe holder
Magnetic Interference: Keep away from strong fields (phones, magnets) to avoid errors
Battery Care: Remove batteries during long storage to prevent leakage
Interpretation: Use 6-reading average; “Repeat” = high variance—re-measure
Infection Control: Examine contagious cases last; full disinfection
九、存储条件 (Storage Conditions)
中文
温度：-10℃ ～ +55℃（长期存储）；+10℃ ～ +35℃（操作）
湿度：10% ～ 95%RH，无冷凝
环境：干燥、清洁、通风，远离腐蚀气体、酸碱、粉尘、强磁场
放置：原装便携盒，防震、防潮、防尘，避免阳光直射
长期存储：取出电池，清洁机身，密封防潮；定期检查
运输：-40℃ ～ +70℃，10%–95% RH，500–1060hPa，防震包装
English
Temperature: -10°C to +55°C (long-term); +10°C to +35°C (operation)
Humidity: 10–95%RH, non-condensing
Environment: Dry, clean, ventilated; away from corrosives, acids, dust, strong magnetic fields
Storage: Original case; shock/moisture/dust-proof; avoid direct sunlight
Long-Term: Remove batteries, clean body, seal dry; inspect periodically
Transport: -40°C to +70°C, 10–95%RH, 500–1060hPa; shockproof packaging
十、说明书核心信息 (Manual Core Inｆormation)
中文
产品分类：二类医疗器械（国械注进）
制造商：芬兰 iCare Oy（原装进口）
型号规格：TA031（商品名 iCare IC200）
结构组成：主机、一次性探针（TP02）、前额支撑、腕带、说明书、便携盒
执行标准：ISO 13485, ISO 8098, EN 60601-1/-2, FDA K190316
保修期限：2 年（主机，不含探针、电池、耗材）
维护周期：每日清洁；无需校准；年度功能检查
耗材：一次性无菌探针（TP02）、AA 碱性电池
消毒方式：机身 / 前额支撑：70% 异丙醇擦拭；探针：一次性使用
废弃处理：按 WEEE 医疗电子废弃物规范；探针按医疗锐器处理
使用权限：处方药（Rx），医疗机构、专业人员指导下使用
English
Classification: Class II Medical Device (NMPA/FDA/CE)
Manufacturer: iCare Oy, Finland (Imported)
Model: TA031 (Trade Name: iCare IC200)
Components: Main unit, disposable probes (TP02), forehead rest, wrist strap, manual, case
Standards: ISO 13485, ISO 8098, EN 60601-1/-2, FDA K190316
Warranty: 2 Years (main unit; excl. probes, batteries, consumables)
Maintenance: Daily cleaning; no calibration; annual functional check
Consumables: Single-use sterile probes (TP02), AA alkaline batteries
Disinfection: Body/forehead rest: 70% isopropyl wipe; Probes: Single-use
Disposal: Per WEEE regulations; probes as medical sharps
Restriction: Rx only; for use in medical facilities by trained professionals
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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