厂商直供安视康眼科光学生物测量仪Swan 600P,Swan 600
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厂商直供安视康眼科光学生物测量仪Swan 600P,Swan 600
桂经理19117326863微xin同号
桂经理19117326863微xin同号
管理类别
第二类
型号规格
Swan 600P、Swan 600
结构及组成/主要组成成分
由主机（电源、连接线、相机镜头、屏幕、PC小主机、控制电路板、电机、光源、采集卡、探测器、操作手柄、底座、外壳、额托）和电源适配器组成。
适用范围/预期用途
用于测量具有固视能力并且年龄在3岁及以上人群的眼轴长度、角膜厚度、前房深度、晶状体厚度、角膜曲率半径、轴位角、白到白距离、瞳孔直径8个参数。
1、工作原理 Working Principle
中文：采用光学低相干反射（OLCR）干涉技术，850nm 红外光源发射探测光入射人眼，不同眼组织界面产生反射光，与参考光发生干涉；探测器采集干涉信号，经算法解析各层眼部结构反射信号，一次性计算输出眼轴、角膜、前房、晶状体等多项眼部生物参数；Swan600P 优化光源与算法，提升白内障等混浊眼组织的信号穿透与识别能力。English：Adopts Optical Low‑Coherence Reflectometry (OLCR) interference technology. An 850 nm infrared light source emits probe light into human eye. Reflected light from different intra‑ocular tissue interfaces interferes with reference light. Detector acquires interference signals, and algorithms analyze reflected signals of multi‑ｌayer ocular structures to calculate multiple biometric parameters including axial length, cornea, anterior chamber and lens. Swan 600P optimizes light source and algorithm to improve signal penetration and recognition for cataract and other opaque ocular tissues。
2、功能 Functions
中文：①非接触测量眼轴长度、角膜厚度、前房深度、晶状体厚度、角膜曲率半径、轴位角、白‑白距离、瞳孔直径共 8 项眼部生物参数；②音画固视吸引功能，辅助受检者固视；③自动对焦、一键快速测量；④内置多套人工晶体计算公式，支持 IOL 度数测算；⑤测量数据存储、查询、报告输出；⑥触控屏操作，支持外接显示器输出。English：①Non‑contact non‑invasive measurement of 8 ocular biometric parameters: axial length, corneal thickness, anterior chamber depth, lens thickness, corneal curvature radius, axis angle, white‑to‑white distance and pupil diameter; ②Audio‑visual fixation attraction function to assist subject fixation; ③Auto‑focus and one‑key rapid measurement; ④Multiple built‑in IOL calculation ｆormulas for intraocular lens power calculation; ⑤Measurement data storage, query and report output; ⑥Touch‑screen operation, supporting external display output。
3、产品特点 Product Features
中文：①1 秒极速测量，测量效率高；②非接触式测量，无需表面麻醉，；③自动对焦，降低操作难度；④音画吸引系统，适配低龄儿童检查；⑤Swan600P 增强混浊眼（白内障）测量能力；⑥一体化触控主机，结构紧凑；⑦微米级测量精度，重复性好；⑧支持多格式报告导出，适配眼科临床、近视防控、白内障术前评估场景。English：①1‑second ultra‑fast measurement with high efficiency; ②Non‑contact and non‑invasive, no topical anesthesia required; ③Auto‑focus reduces operation difficulty; ④Audio‑visual attraction system suitable for young children; ⑤Swan 600P enhances measurement perｆormance for opaque eyes such as cataract; ⑥Integrated touch‑screen main unit with compact structure; ⑦Micrometer‑level measurement accuracy with good repeatability; ⑧Multi‑ｆormat report export, suitable for ophthalmology clinic, myopia prevention & control and pre‑operative cataract evaluation。
4、技术参数 Technical Parameters
中文
光源波长：850nm 红外光，入眼功率≤0.78 mW
眼轴长度测量范围：12.0 mm‑38.0 mm
角膜曲率半径精度：±10 µm；晶状体厚度精度：±50 µm
瞳孔直径测量精度：±0.3 mm；白‑白距离精度：±0.2 mm
单次测量时间：约 1 s
显示屏：9 英寸触控屏，支持外接显示器
适用受检者：具备固视能力，3 岁及以上人群
供电：AC100‑240V，配套电源适配器
型号区分：Swan 600 为标准版；Swan 600P 为增强版，优化白内障患者测量算法
English
Light source wavelength: 850 nm infrared, incident power ≤0.78 mW
Axial length measurement range: 12.0 mm‑38.0 mm
Corneal curvature radius accuracy: ±10 µm; Lens thickness accuracy: ±50 µm
Pupil diameter accuracy: ±0.3 mm; White‑to‑white distance accuracy: ±0.2 mm
Single measurement time: approx.1 s
Display: 9‑inch touch screen, support external monitor
Subject requirement: subjects aged ≥3 years with fixation capability
Power supply: AC100‑240V with matched power adapter
Model difference: Swan 600 is standard version; Swan 600P is enhanced version with optimized algorithm for cataract patients
5、使用方法 Operation Method
中文
开机预热，完成设备自检与光路校准；
清洁额托、下颌托，受检者坐于仪器前，下颌放置下颌托，额头贴紧额托；
开启音画吸引模式引导受检者注视仪器内部视标；
操作手柄移动测量头，设备自动对焦对准瞳孔中心；
触发测量，1 秒完成采集，获取多组测量数据；
选取有效测量结果，调取人工晶体公式计算 IOL 度数；
保存、预览、打印 / 导出报告；
测量结束，关机，清洁设备接触部位。
English
Power‑on for warm‑up, complete self‑test and optical path calibration;
Clean forehead rest and chin rest. Let subject sit in front of instrument, place chin on chin rest and forehead against forehead rest;
Turn on audio‑visual attraction mode to guide subject to fixate on internal target;
Move measuring head via handle, device auto‑focuses to pupil center;
Trigger measurement; data acquisition finishes within 1 s to obtain multiple groups of data;
Select valid measurement results, invoke IOL ｆormulas to calculate intraocular lens power;
Save, preview, print or export reports;
After measurement, power‑off and clean contact parts of device.
6、适应症 Indications
中文：适用于具备固视能力、3 岁及以上人群，测量眼轴长度、角膜厚度、前房深度、晶状体厚度、角膜曲率半径、轴位角、白‑白距离、瞳孔直径；用于儿童青少年近视防控眼生物学参数监测、屈光状态评估、白内障术前生物测量、人工晶体度数测算、屈光手术术前评估。English：Intended for subjects aged ≥3 years with fixation capability, to measure axial length, corneal thickness, anterior chamber depth, lens thickness, corneal curvature radius, axis angle, white‑to‑white distance and pupil diameter. For ocular biometric monitoring in juvenile myopia prevention & control, refractive status evaluation, pre‑operative biometry for cataract, intraocular lens power calculation and pre‑refractive‑surgery assessment。
7、禁忌症 Contraindications
中文：①无固视能力、无法配合注视视标的患者；②严重眼睑闭合不全、严重眼球震颤、严重角膜混浊无法形成有效光学信号；③眼表活动性感染、严重眼外伤未处理；④不用于眼内治疗，不可作为独立诊断依据，测量结果仅供医师临床参考。English：①Patients without fixation ability and unable to fixate on target; ②Severe blepharophimosis, severe nystagmus, severe corneal opacity preventing valid optical signal acquisition; ③Active ocular surface infection, untreated severe ocular trauma; ④Not for intraocular therapy; measurement results are for physician reference only and shall not be used as sole diagnostic basis.
8、注意事项 Precautions
中文
仅由经过培训的眼科专业人员操作；
测量前清除受检者眼表化妆品、睫毛膏，避免遮挡光路；
设备避免强光直射、震动、撞击；移动设备必须锁定测量臂；
不可直视仪器内部光源；
定期做设备校准，出现报错立即停止使用，联系售后；
额托、下颌托做好消毒，避免交叉感染；
对于白内障、重度屈光间质混浊患者，优先选用 Swan600P，仍需结合其他眼科检查综合判读；
设备输出数据仅为辅助检查，不能替代眼科医师综合诊断；
禁止在开机带电状态下插拔内部线缆。
English
Operated only by trained ophthalmic professionals;
Remove eye cosmetics and mascara before measurement to avoid optical path obstruction;
Protect device from strong light, vibration and impact; lock measuring arm before moving instrument;
Do not stare directly at internal light source;
Perｆorm periodic calibration; stop operation immediately when error occurs and contact service;
Disinfect forehead rest and chin rest to prevent cross‑infection;
For patients with cataract or severe refractive media opacity, prefer Swan 600P; results shall be interpreted combined with other ophthalmic examinations;
Output data is for auxiliary examination only and cannot replace comprehensive diagnosis by ophthalmologist;
Do not plug/unplug internal cables while device is powered‑on.
9、存储条件 Storage Conditions
中文：环境温度：‑10℃～+55℃；相对湿度：10%～80%（无冷凝）；大气压力：70kPa‑106kPa；存放于干燥通风室内，避免阳光直射、粉尘、腐蚀性气体，避免剧烈震动。运输时做好缓冲防护。English：Ambient temperature:‑10℃～+55℃; Relative humidity:10%‑80% non‑condensing; Atmospheric pressure:70kPa‑106kPa. Store in dry and ventilated indoor space, avoid direct sunlight, dust, corrosive gas and violent vibration. Apply buffer protection during transportation.
10、说明书核心摘要 Core Summary of IFU
中文：本产品为二类眼科光学生物测量仪，Swan600 标准版、Swan600P 增强版；采用 OLCR 光学低相干反射技术，非接触式获取 8 项眼部生物参数；用于 3 岁以上具备固视能力人群的眼生物参数检测，服务近视防控、白内障术前 IOL 测算；需专业人员操作，做好消毒与定期校准；结果仅供临床参考，不能单独作为确诊依据；远离强光、震动，按要求存储运输。English：This is Class‑II ophthalmic optical biometer, including standard version Swan 600 and enhanced version Swan 600P. Adopting OLCR optical low‑coherence reflectometry, it acquires 8 ocular biometric parameters in non‑contact mode. Intended for subjects ≥3 years old with fixation ability for myopia prevention & control and pre‑cataract‑surgery IOL power calculation. Operation shall be perｆormed by professionals with proper disinfection and periodic calibration. Measurement results are for clinical reference only and shall not serve as sole diagnostic evidence. Keep away from strong light and vibration; store and transport as specified.
免责声明：以上产品详情仅供参考，临床操作请以原厂纸质说明书为准。上海康世达医疗器械有限公司不生产医疗产品，所有产品均来自产品的生产厂家，代理商，经销商，如有侵权请联系我们，会尽快处理！The above product details are for reference only. All clinical operations shall be carried out in strict accordance with the original paper instructions for use issued by the manufacturer.
Shanghai Kangshida Medical Devices Co., Ltd. does not manufacture medical devices. All products are sourced from respective manufacturers, authorized agents and distributors.
Please contact us promptly in case of any infringement, and we will resolve the matter as soon as possible.
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