厂家直供睛乐Keeler数码压平眼压计D-KAT
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厂家直供睛乐Keeler数码压平眼压计D-KAT
桂经理19117326863微xin同号
管理类别
第二类
型号规格
见附页
结构及组成/主要组成成分
该产品由主机、双像棱镜和校准组件组成。其中，主机由电源/功能按钮、主体机、旋转式测量旋钮、测量臂、安装组件和LED显示屏组成。
适用范围/预期用途
数码压平眼压计在医疗机构中，临床作患者眼内压力检查测量。
一、工作原理（Working Principle）
中文基于Goldmann 压平眼压测量法（国际准）。通过仪器测压头的亚克力棱镜，将角膜中央3.06mm 恒定直径（7.354mm² 面积）区域压平；内置高精度压力传感器实时检测压平角膜所需的外力，依据Imber-Fick 定律（眼压与压平力成正比），将力学信号转换为电信号，经微处理器计算眼压值（mmHg），并以1 位小数在 LED 屏数字显示。裂隙灯蓝光照射下，荧光素染色的角膜形成两个对称绿色半圆环，当内缘相切时为测量终点。
EnglishBased on the Goldmann Applanation Method (international gold standard). An acrylic prism on the sensor head flattens a constant 3.06mm diameter (7.354mm² area) of the central cornea. A high-precision pressure sensor detects the force required; per the Imber-Fick Law (IOP proportional to applanation force), the signal is processed by a microcontroller to calculate IOP, digitally displayed to 1 decimal place on an LED screen. Under slit-lamp blue light, fluorescein-stained cornea ｆorms two green semicircles—measurement ends when inner edges precisely touch。
二、产品功能（Functions）
中文
眼压测量：5–65mmHg 全范围测量，精度 ±0.49mN 或测量值的 1.5%（取较大值）
数字直显读数：高亮 LED 屏，1 位小数显示，暗室清晰可读，消除机械刻度读数误差
双模式适配：R 型（固定于裂隙灯光学柱）、T 型（可拆卸，多裂隙灯共享）
测量辅助校准：荧光素半圆环对齐判定，确保压平位置
智能状态提示：低电量、测量异常、校准提醒声光反馈
参数自定义：屏幕亮度、音量、小数点显示模式可调
快速校准：专用校准臂，30 秒完成年度校准，无需专业工具
兼容主流裂隙灯：适配 H 型（塔式）、Z 型（蔡司式）照明系统
English
Precise IOP Measurement: 5–65mmHg range, accuracy ±0.49mN or 1.5% of reading (whichever greater)
Digital Direct Readout: Bright LED, 1 decimal place, clear in dark rooms, eliminates mechanical scale errors
Dual Mount Versions: R-type (fixed to slit lamp post); T-type (detachable, multi-lamp sharing)
Visual Alignment Aid: Fluorescein semicircles for precise applanation endpoint
Smart Status Alerts: Audio-visual feedback for low battery, errors, calibration reminders
Customizable Settings: Adjustable display brightness, volume, decimal ｆormat
Rapid Calibration: Calibration arm, 30-second annual calibration, no special tools
Universal Slit Lamp Compatibility: Fits H-style (tower) & Z-style (Zeiss) illumination
三、产品特点（Product Features）
中文
准数字化：Goldmann 法 + 电子传感，精度与可靠性超越机械款
无视觉读数误差：数字直显，避免人为判读偏差，结果客观可追溯
双型号全适配：R 型固定稳定；T 型便携可拆卸，提升设备利用率
高亮 OLED/LED 屏：暗室高对比度，1 位小数读数
超低功耗：单节 AA 电池续航≥12 个月（常规使用），低电量提醒
极简操作：单旋钮调节压力，一键开关机，单手可控
耐用光学设计：可重复消毒棱镜，防刮耐磨，寿命≥2 年
临床安全设计：非侵入式接触，压力可控，无角膜损伤风险
英制精密制造：Keeler 英国原厂，符合 ISO 15004、EN 60601 医疗标准
English
Goldmann Standard Digitalized: Goldmann method + electronic sensing, superior accuracy/reliability vs mechanical
Zero Reading Error: Digital display eliminates human judgment bias, ｏbjective/auditable
Dual-Model Flexibility: R-type fixed stability; T-type portable/detachable for multi-clinic use
High-Contrast LED Display: Clear in dark rooms, 1 decimal place precision
Ultra-Low Power: 1x AA battery ≥12 months (typical), low-battery alert
Simplified Operation: Single pressure dial, one-button power, single-hand control
Durable Optics: Reusable autoclavable prism, scratch-resistant, 2-year service life
Clinically Safe: Controlled contact force, no corneal trauma risk
UK Precision Manufacturing: Keeler UK-built, ISO 15004, EN 60601 certified
四、技术参数（Technical Specifications）
中文
型号：D-KAT R 型（固定）、T 型（可拆卸）、Z 型（蔡司专用）
测量原理：Goldmann 压平法，3.06mm 恒定压平直径
测量范围：5–65 mmHg（0.66–8.65 kPa）
测量精度：≤±0.49 mN 或测量值的 1.5%（取较大值）
显示方式：绿色 LED 数字屏，1 位小数（0.1mmHg）
压平棱镜：可重复消毒亚克力双棱镜，直径 3.06mm
供电：1×AA 碱性 / 锂电池（1.5V），续航≥12 个月
尺寸重量：110×60×50mm；约 0.6kg（不含配件）
操作环境：温度 + 10℃～+35℃，湿度 30%–75% RH，气压 800–1060hPa
存储环境：温度 - 10℃～+55℃，湿度 10%–95% RH，气压 700–1060hPa
标准认证：CE、FDA、ISO 13485、ISO 15004、EN 60601
校准：专用校准臂，年度校准，30 秒完成
English
Models: D-KAT R (fixed), T (detachable), Z (Zeiss-specific)
Principle: Goldmann applanation, 3.06mm fixed diameter
Range: 5–65 mmHg (0.66–8.65 kPa)
Accuracy: ≤±0.49 mN or 1.5% of reading (whichever greater)
Display: Green LED digital, 1 decimal place (0.1mmHg)
Prism: Reusable autoclavable acrylic doubling prism, 3.06mm
Power: 1×AA alkaline/Li battery (1.5V), ≥12 months life
Size/Weight: 110×60×50mm; ~0.6kg (without accessories)
Operating: +10°C to +35°C, 30–75%RH, 800–1060hPa
Storage: -10°C to +55°C, 10–95%RH, 700–1060hPa
Certifications: CE, FDA, ISO 13485, ISO 15004, EN 60601
Calibration: Calibration arm, annual, 30-second procedure
五、使用方法（Instructions for Use）
中文
准备
安装至裂隙灯（R 型固定；T 型装滑台），安装 AA 电池，开机自检
调节屏幕亮度、音量；用校准臂验证精度（年度必校）
消毒棱镜：70% 酒精擦拭，无菌水冲洗，晾干
患者准备
表麻滴眼液（如丙美卡因）滴患眼 1–2 次，等待 30 秒
荧光素试纸轻触下睑结膜囊，泪液染色后移除
患者坐裂隙灯前，头靠额托 / 下颌托，注视目标
测量操作
裂隙灯调 10× 倍率、钴蓝光、窄裂隙
缓慢前移使棱镜轻触角膜中央，观察荧光素半圆环
旋转压力旋钮至两半圆环内缘相切、均匀对齐
稳定 2 秒，读取 LED 屏数值（保留 1 位小数）
每眼测 2 次，差值≤1mmHg 取平均；否则重测
结束
后撤裂隙灯，关闭光源，取下棱镜清洁消毒
关机，放回保护盒；记录眼压值、测量时间、眼别
English
Preparation
Mount to slit lamp (R-type fixed; T-type on slide), install AA battery, power-on self-test
Adjust display/volume; verify accuracy with calibration arm (annual mandatory)
Disinfect prism: 70% alcohol wipe, sterile water rinse, air-dry
Patient Prep
Instill 1–2 drops topical anesthetic (e.g., proparacaine), wait 30s
Touch fluorescein strip to lower conjunctival sac, remove after staining
Patient positioned at slit lamp, head stabilized, fixating target
Measurement
Slit lamp: 10× mag, cobalt blue filter, narrow slit
Advance slowly until prism gently touches central cornea; view fluorescein semicircles
Rotate dial until inner edges of semicircles precisely touch & align evenly
Hold 2s, read LED value (1 decimal place)
2 readings/eye; average if ≤1mmHg difference; repeat if not
Completion
Retract slit lamp, turn off light, clean/disinfect prism
Power off, store in case; document IOP, time, eye
六、适应症（Indications）
中文
青光眼筛查与诊断：眼压监测、确诊、分期、风险评估
青光眼随访：药物 / 手术 / 激光治疗后疗效监测、眼压波动评估
眼科常规体检：成人 / 老年人 / 高危人群（近视、糖尿病、家族史）基础眼压检测
屈光术前评估：近视 / 远视 / 散光手术前排除青光眼、高眼压症
全身病相关眼压监测：糖尿病、高血压、心血管病、长期激素使用者
眼外伤 / 术后评估：眼球挫伤、内眼术后眼压监测（青光眼、白内障术后）
儿童 / 特殊人群：配合度可患儿、卧床患者、床旁急诊眼压测量
English
Glaucoma Screening & Diagnosis: IOP monitoring, confirmation, staging, risk assessment
Glaucoma Follow-Up: Post-medication/surgery/laser efficacy, IOP fluctuation evaluation
Routine Ocular Exams: Baseline IOP for adults/elderly/at-risk (myopia, diabetes, family history)
Refractive Surgery Pre-Assessment: Rule out glaucoma/OHT before laser vision correction
Systemic Disease Monitoring: Diabetes, hypertension, cardiovascular disease, long-term steroid users
Trauma/Post-Op Care: Ocular contusion, post-intraocular surgery (glaucoma, cataract) IOP checks
Pediatric/Special Populations: Cooperative children, bedridden, emergency bedside use
七、禁忌症（Contraindications）
中文
绝对禁忌：
眼球破裂伤、开放性眼外伤、眼内容物脱出
角膜活动性溃疡、穿孔、大面积上皮缺损、严重水肿混浊
对表麻剂 / 荧光素严重过敏者
无法配合、严重眼睑痉挛、眼球震颤（无法稳定测量）
相对禁忌（谨慎 / 避免）：
角膜厚度异常（＜500µm 或＞600µm）、角膜屈光术后（测量偏差大）
急性结膜炎 / 角膜炎 / 葡萄膜炎（感染期，交叉感染风险）
严重干眼、角膜变性、大泡性角膜病变（接触加重损伤）
English
Absolute Contraindications:
Ruptured globe, open ocular trauma, intraocular content prolapse
Active corneal ulcer, perforation, large epithelial defect, severe edema/opacity
Severe allergy to topical anesthetics/fluorescein
Uncooperative, severe blepharospasm, nystagmus (unstable measurement)
Relative Contraindications (Caution/Avoid):
Abnormal corneal thickness (<500µm or >600µm), post-refractive surgery (large bias)
Acute conjunctivitis/keratitis/uveitis (infectious stage, cross-contamination risk)
Severe dry eye, corneal degeneration, bullous keratopathy (contact worsens damage)
八、注意事项（Precautions）
中文
人员资质：眼科 / 视光专业医师 / 技师操作，需专项培训
散瞳风险：测量前评估前房深度，闭角型青光眼禁散瞳
角膜保护：棱镜必须无菌消毒，禁止重复使用未消毒棱镜
操作轻柔：轻触角膜，禁止用力按压，避免擦伤内皮
偏差修正：角膜偏薄 / 偏厚、屈光术后需校正公式修正读数
棱镜检查：每次使用前查棱镜划痕 / 破损，有损伤立即更换
电池安全：长期不用取出电池，防漏液腐蚀；仅用原厂电池
清洁规范：机身用 70% 异丙醇擦拭；光学面禁用酒精，用镜头纸
校准维护：每年强制校准，运输 / 摔落后立即校准
感染控制：每患者后消毒棱镜；结膜炎 / 感染眼检查
English
Personnel: Only trained ophthalmic/optometric professionals
Mydriasis Risk: Assess anterior chamber depth; no dilation for angle-closure glaucoma
Corneal Safety: Prism must be sterile/disinfected; no reuse without disinfection
Gentle Technique: Light contact only; no forceful pressure to avoid endothelial injury
Bias Correction: Use correction ｆormula for thin/thick corneas, post-refractive surgery
Prism Inspection: Check for scratches/cracks pre-use; replace if damaged
Battery Care: Remove battery long-term; use only manufacturer’s batteries
Cleaning Rules: Body: 70% isopropyl wipe; optics: lens tissue only (no alcohol)
Calibration: Annual mandatory calibration; re-calibrate after transport/drop
Infection Control: Disinfect prism per patient; examine infected eyes last
九、存储条件（Storage Conditions）
中文
温度：-10℃ ～ +55℃
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：原装保护盒，光学面朝上，防震、防压、防潮
长期存储：取出电池，密封防潮袋；避免阳光直射、剧烈震动
运输条件：-40℃ ～ +70℃，湿度 10%–95% RH，气压 500–1060hPa
English
Temperature: -10°C to +55°C
Humidity: 10–95%RH, non-condensing
Environment: Dry, clean, ventilated; away from corrosive gases, acids, dust, strong magnetic fields
Storage: Original protective case, optics facing up, shock/pressure/moisture protected
Long-Term: Remove battery, sealed dry bag; avoid direct sunlight, vibration
Transport: -40°C to +70°C, 10–95%RH, 500–1060hPa
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：Keeler Ltd（英国温莎）
型号规格：D-KAT R 型、T 型、Z 型（蔡司）
执行标准：ISO 13485、ISO 15004、EN 60601-1/-2、YY 0065
保修期限：2 年（棱镜、电池、耗材除外）
维护周期：每日清洁消毒；年度校准；每 2 年更换棱镜
耗材清单：可重复消毒棱镜、一次性荧光素试纸、AA 电池、镜头纸
消毒方式：棱镜：70% 酒精 / 高温高压灭菌；机身：70% 异丙醇擦拭
废弃处理：按电子医疗废弃物规范；棱镜按感染性废物处理
处方要求：处方药，医师 / 执业医师指导下销售使用
English
Classification: Class II Medical Device (NMPA)
Manufacturer: Keeler Ltd, Windsor, UK
Models: D-KAT R, T, Z (Zeiss)
Standards: ISO 13485, ISO 15004, EN 60601-1/-2, YY 0065
Warranty: 2 years (excl. prism, battery, consumables)
Maintenance: Daily clean/disinfect; annual calibration; prism replace every 2 years
Consumables: Reusable prism, disposable fluorescein strips, AA battery, lens tissue
Disinfection: Prism: 70% alcohol/autoclave; Body: 70% isopropyl wipe
Disposal: Electronic medical waste regulations; prism as infectious waste
Preｓcription: Rx only, sale/use under physician supervision
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.
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：厂家直供睛乐Keeler数码压平眼压计D-KAT,睛乐数码压平眼压计,数码压平眼压计D-KAT
