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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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厂商供应Keeler凯乐晴乐压平眼压计KAT R-Type,KAT T-Type

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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20162162267更新时间:2026/10/16 11:04:34

产品摘要:厂商供应Keeler凯乐晴乐压平眼压计KAT R-Type,KAT T-Type

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详细内容

厂商供应Keeler凯乐晴乐压平眼压计KAT R-Type,KAT T-Type
桂经理19117326863微xin同号

管理类别

第二类

型号规格

• KAT(基础机械压平眼压计)

◦ KAT R-Type(立柱固定式)

◦ KAT T-Type(可拆卸式/导板式)

结构及组成/主要组成成分

产品由压重控制箱、双像棱镜、测量臂、测量旋钮、安装组件和校准组件组成。

适用范围/预期用途

临床用于患者眼内压力检查测量。

一、工作原理(Working Principle)

中文基于戈德曼(Goldmann)压平眼压测量法(国际准):通过眼压计测压头,以恒定力量压平角膜3.06mm直径的固定圆形区域,根据压平该面积所需的外力(机械力或电子传感力),换算得出眼内压(IOP)数值。测量时借助钴蓝光观察荧光素染色形成的两个半圆 “米尔斯”(Mires),当内缘相切对齐时,即为测量平衡点。

EnglishBased on the Goldmann Applanation Principle (international gold standard): The tonometer head applies force to flatten a fixed circular corneal area 3.06mm in diameter. Intraocular pressure (IOP) is calculated from the force required to achieve this applanation (mechanical or electronic). Using cobalt blue light, the examiner aligns the inner edges of two fluorescein-stained semicircles (“mires”)—when perfectly tangent, the equilibrium point is reached.

二、产品功能(Functions)

中文

测量眼压:0–80 mmHg(0–10.64 kPa)范围,用于青光眼筛查、诊断与监测

机械 / 数字双版本:KAT(机械刻度)、D-KAT(数字 LED 显示,精度 0.1 mmHg)

裂隙灯适配:R 型(固定于裂隙灯光学柱)、T 型(可拆卸,多裂隙灯共用)、Z 型(适配蔡司 Z 型裂隙灯)

快速测量:单眼测量约 10 秒,双眼 30 秒内完成

校准验证:内置校准臂,支持日常精度核查

数据读取:机械刻度直读 / 数字屏显,可设声音提示

English

Precise IOP Measurement: 0–80 mmHg (0–10.64 kPa) range for glaucoma screening, diagnosis & monitoring

Mechanical/Digital Versions: KAT (mechanical scale), D-KAT (digital LED display, 0.1 mmHg resolution)

Slit Lamp Compatibility: R-Type (fixed to optical post), T-Type (detachable, multi-slit lamp use), Z-Type (for Zeiss Z-style)

Rapid Measurement: ~10 sec/eye, both eyes in <30 sec

Calibration Check: Built-in calibration arm for daily accuracy verification

Reading: Mechanical dial / digital display with optional audio alert

三、产品特点(Features)

中文

英国精工制造:精密机加工,全流程质控,光学与机械稳定性强

准测量:严格遵循 Goldmann 法,临床公认最准确、重复性最佳

双型号设计:R 型固定、T 型快拆,适配不同诊室流程

数字版优势:LED 屏、低功耗、活动部件少、高可靠、易维护

人体工学:棱镜定位、操作顺滑、裂隙灯协同舒适

棱镜耐用:可重复消毒使用,光学性能稳定

合规认证:符合 ISO 15004、YY 0065,二类医疗器械注册

English

UK Precision Manufacture: Precision-machined, full QC, superior optical & mechanical stability

Gold Standard Accuracy: True Goldmann method—clinically most accurate & repeatable

Dual Mount Design: R-Type fixed, T-Type quick-release for workflow flexibility

Digital Advantages: LED display, low power, minimal moving parts, high reliability, low maintenance

Ergonomics: Precise prism alignment, smooth operation, slit lamp integration

Durable Prism: Reusable & autoclavable, stable optics

Certified: ISO 15004, YY 0065 compliant, Class II medical device




四、技术参数(Technical Specifications)

中文

型号:KAT(机械)、D-KAT(数字);R 型 / T 型 / Z 型

测量原理:Goldmann 压平法

测量范围:0–80 mmHg(0–10.64 kPa)

精度:机械 ±0.5 mmHg;数字 **±0.1 mmHg**

压平直径:3.06 mm

显示:机械刻度 / LED 数字(1 位小数)

供电(D-KAT):1×AA 碱性电池,续航约 1 年

材质:工程合金、精密光学玻璃、防腐蚀涂层

重量:约 280 g(不含支架)

标准:ISO 15004-2、YY 0065

English

Model: KAT (mech), D-KAT (digital); R/T/Z Types

Principle: Goldmann Applanation

Range: 0–80 mmHg (0–10.64 kPa)

Accuracy: Mech ±0.5 mmHg; Digital ±0.1 mmHg

Applanation Diameter: 3.06 mm

Display: Mechanical dial / LED (1 decimal place)

Power (D-KAT): 1×AA battery, ~1 year life

Materials: Engineering alloy, precision optical glass, corrosion-resistant coating

Weight: ~280 g (excl. mount)

Standards: ISO 15004-2, YY 0065

五、使用方法(Instructions for Use)

中文

安装:T 型插入裂隙灯导板;R 型固定于显微镜柱;Z 型适配蔡司支架

患者准备:表麻滴眼液(如丙美卡因);荧光素钠试纸染色泪膜

设备设置:裂隙灯 10× 放大;钴蓝滤光片;裂隙全开、光源 - 显微镜约 60°

测量

棱镜轻触角膜中央

观察荧光素半圆,调节压力使内缘相切

读取刻度(KAT)或 LED 数值(D-KAT)

记录:记录 mmHg 值,双眼对比

后处理:移开棱镜;消毒棱镜;清洁设备;关机 / 断电

English

Mount: T-Type slide into guide plate; R-Type fix to microscope post; Z-Type for Zeiss mount

Patient Prep: Topical anesthetic (e.g., proparacaine); fluorescein strip to stain tear film

Slit Lamp Setup: 10× magnification; cobalt blue filter; full slit width, light–microscope ~60°

Measure

Gently place prism on central cornea

Align inner edges of fluorescein semicircles to exact tangency

Read dial (KAT) or LED (D-KAT)

Record: Document mmHg, compare both eyes

Finish: Withdraw prism; disinfect prism; clean; power off

六、适应症(Indications)

中文

青光眼筛查、诊断、病情监测与疗效评估

高眼压症、正常眼压性青光眼鉴别

近视 / 远视 / 白内障术前术后眼压监测

长期激素用药、眼内炎症患者眼压随访

无法配合非接触眼压计者(婴幼儿、震颤、焦虑)

English

Glaucoma screening, diagnosis, monitoring & treatment response

Differentiate ocular hypertension vs. normal-tension glaucoma

Pre-/post-op IOP for myopia, hyperopia, cataract surgery

Follow-up for long-term steroids, intraocular inflammation

Patients unable to cooperate with non-contact tonometry (infants, nystagmus, anxiety)

七、禁忌症(Contraindications)

中文

角膜上皮缺损、糜烂、溃疡、活动性角膜炎 / 结膜炎

眼球破裂伤、角膜穿孔 / 水肿严重、眼表急性感染

对表麻药、荧光素过敏者

无法睁眼、严重眼睑痉挛、不配合者

角膜严重瘢痕 / 变形(影响压平精度)

English

Corneal epithelial defect, erosion, ulcer, active keratitis/conjunctivitis

Ruptured globe, corneal perforation, severe edema, acute ocular infection

Allergy to topical anesthetic or fluorescein

Inability to open eyes, severe blepharospasm, non-cooperative

Severe corneal scarring/deformity (invalidates applanation accuracy)

八、注意事项(Precautions)

中文

眼科 / 视光专业人员操作

测量前必须表麻,禁止无麻醉接触

棱镜必须消毒(70% 酒精 / 戊二醛),防交叉感染

棱镜有划痕、磨损立即更换,避免损伤角膜

操作轻柔,禁止施压过大,防止角膜损伤

角膜偏厚 / 偏薄、屈光术后需校正误差(如 DCR 公式)

每日用校准臂核查精度;定期返厂校准

儿童 / 老人需专人固定头部,防意外碰撞

English

Only by trained ophthalmic/optometric professionals

Must use topical anesthesia—no contact without anesthestic

Full disinfection (70% alcohol/glutaraldehyde) of prism to prevent cross-infection

Replace prism if scratched/worn to avoid corneal injury

Gentle technique—avoid excessive force

Correct for thick/thin cornea, post-refractive surgery (e.g., DCR)

Daily check with calibration arm; factory calibration periodically

Head stabilization for children/elderly to avoid collision

九、存储条件(Storage Conditions)

中文

温度:-10℃~+50℃

湿度:≤80% RH,无冷凝

环境:干燥、通风、清洁;远离腐蚀气体、强酸强碱、强磁场

放置:原装保护盒,棱镜朝上、防震防压

长期存放:D-KAT 取出电池;棱镜单独无菌存放

避免:阳光直射、高温、潮湿、剧烈震动、摔落

English

Temperature: -10°C to +50°C

Humidity: ≤80%RH, non-condensing

Environment: Dry, ventilated, clean; away from corrosive gases, acids, strong magnetic fields

Storage: Original case, prism upward, shock & pressure protection

Long-term: Remove D-KAT batteries; store prism sterile separately

Avoid: Direct sunlight, heat, moisture, vibration, dropping

十、说明书核心信息(Manual Core Info)

中文

分类:二类医疗器械

注册证:国械注进(以批件为准)

制造商:Keeler Ltd(英国温莎)

型号:KAT(2414-P-2040 等)、D-KAT(2414-P-2032 等)

标准:ISO 15004-2、YY 0065-2017

保修:2 年(光学 / 棱镜 / 电池除外)

维护:每日校准检查;棱镜定期更换(≤2 年)

消毒:机身擦拭;棱镜高水平消毒 / 灭菌

耗材:荧光素试纸、表麻药、备用棱镜、AA 电池

处置:按电子医疗废弃物规范处理

English

Class: Class II Medical Device

Registration: China NMPA (current certificate)

Manufacturer: Keeler Ltd, Windsor, UK

Model: KAT (2414-P-2040), D-KAT (2414-P-2032)

Standards: ISO 15004-2, YY 0065-2017

Warranty: 2 years (excl. optics/prism/batteries)

Maintenance: Daily calibration check; replace prism ≤2 years

Disinfection: Body wipe; prism high-level disinfection/sterilization

Consumables: Fluorescein strips, anesthetic, replacement prism, AA battery

Disposal: per electronic medical waste regulations

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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