厂商供应新视野眼科A/B超声诊断仪RetiWave1000
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厂商供应新视野眼科A/B超声诊断仪RetiWave1000
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
RetiWave1000
结构及组成/主要组成成分
该产品由硬件和软件两部分组成。硬件部分：由主机和探头耦合组成，具体由眼科超声诊断仪主机、脚踏开关、鼠标、键盘、电源适配器、A超探头、B超探头组成。软件部分：软件名称：眼科A/B超；软件型号：RetiWave1000；软件发布版本：1.0。
适用范围/预期用途
该产品适用于眼科检查，A超测量眼轴长度，B超实现眼球及眼眶的超声成像。在医疗机构中使用。
1、工作原理 Working Principle
中文：设备采用 10MHz 高频超声波，A 超模式利用超声波脉冲回波时间差，测量眼部各组织界面反射信号，计算眼轴、前房深度、晶体厚度等生物测量数据；B 超模式将回波信号处理生成二维灰度断层图像，实现眼球、眼眶内部结构成像。超声波在不同眼组织声阻抗界面产生反射，主机采集、解析回波信号完成测量与成像输出。 English：Adopts 10MHz high‑frequency ultrasound. In A‑scan mode, it calculates biometric data such as axial length, anterior chamber depth and lens thickness based on echo time difference of ultrasonic pulses. In B‑scan mode, echo signals are processed into 2‑dimensional grayscale tomographic images for intraocular and orbital structure visualization. Ultrasound reflects at acoustic impedance interfaces of different ocular tissues; the host collects and analyzes echoes to complete measurement and imagingEnochtec。
2、产品功能 Product Functions
中文
A 超生物测量：眼轴长度、前房深度、晶状体厚度测量，支持 6 种人工晶体 IOL 计算公式，自动计算人工晶体度数；
B 超二维成像：眼球、眼眶组织断层成像，图像冻结、存储、回放、标注、测量；
患者管理，检查报告预览、打印输出；
A/B 模式一键切换，增益、时间增益 TGC 可调。
English
A‑scan biometry: measure ocular axial length, anterior chamber depth and lens thickness; support 6 kinds of IOL ｆormulas for intraocular lens power calculation.
B‑scan 2D imaging: tomographic imaging for eyeball and orbit; image freeze, storage, playback, annotation and measurement.
Patient file management, report preview and print output.
One‑key switch between A/B scan mode; adjustable gain and TGC(time‑gain compensation)Nanjing Re...。
3、产品特点 Product Features
中文
A/B 双模式一体化设计，一台设备兼顾生物测量与眼部超声成像；
A 超测量误差≤±0.05mm，测量，适配白内障术前生物测量；
B 超高分辨率成像，轴向分辨率≤0.2mm，横向分辨率≤0.3mm，探测深度≥50mm；
支持 SRK‑T、SRK‑II、HOLLADAY、BINKHORST‑II、HOFFER‑Q、HAIGIS 六种主流 IOL 计算公式；
触摸屏操作，自动 / 手动图像冻结，支持 100 帧图像回放；
接触式 A 超探头，整机便携，适合医院眼科临床使用syseye-ltd...。
English
Integrated A‑scan & B‑scan dual‑mode design, realizing biometry and ocular ultrasound imaging on one unit.
A‑scan measuring error ≤±0.05 mm, high accuracy for pre‑cataract‑surgery biometry.
High‑resolution B‑scan: axial resolution ≤0.2 mm, lateral resolution ≤0.3 mm, detection depth ≥50 mm.
Support six mainstream IOL ｆormulas: SRK‑T, SRK‑II, HOLLADAY, BINKHORST‑II, HOFFER‑Q, HAIGIS.
Touch‑screen operation; auto/manual image freeze; 100‑ｆｆframe image playback function.
Contact‑type A‑scan probe; portable unit for clinical ophthalmology departmentNanjing Re...。
4、技术参数 Technical Parameters
中文
| 项目 | 参数 |
|---|---|
| 探头频率 | 10MHz（A 超、B 超共用） |
| A 超测量方式 | 接触式 |
| A 超测量范围 | 5mm‑40mm |
| A 超测量误差 | ≤±0.05mm |
| A 超 IOL 计算公式 | SRK‑T、SRK‑II、HOLLADAY、BINKHORST‑II、HOFFER‑Q、HAIGIS |
| B 超探测深度 | ≥50mm |
| B 超轴向分辨率 | ≤0.2mm |
| B 超横向分辨率 | ≤0.3mm |
| 增益调节 | 20‑110dB |
| 时间增益 TGC 调节 | 0‑30dB |
| 显示屏 | 彩色触控屏 |
| 整机重量 | 约 10kg |
| 软件版本 | V1.0 |
English
表格
| Item | Specifications |
|---|---|
| Probe Frequency | 10MHz(A‑scan & B‑scan) |
| A‑scan Measuring Mode | Contact type |
| A‑scan Measuring Range | 5mm‑40mm |
| A‑scan Measuring Error | ≤±0.05mm |
| IOL Formulas | SRK‑T, SRK‑II, HOLLADAY, BINKHORST‑II, HOFFER‑Q, HAIGIS |
| B‑scan Detection Depth | ≥50mm |
| B‑scan Axial Resolution | ≤0.2mm |
| B‑scan Lateral Resolution | ≤0.3mm |
| Gain Adjustment | 20‑110dB |
| TGC Adjustment | 0‑30dB |
| Display | Color touch screen |
| Unit Weight | Approx.10kg |
| Software Version | V1.0Enochtec |
5、使用方法 Operation Method
中文
开机：连接电源、探头、脚踏开关，接通电源开机；录入患者信息，选择 A 超或 B 超模式；
A 超测量：患者取平卧位，角膜滴表面麻醉剂；A 超探头酒精消毒；探头垂直轻贴角膜中央；设备自动采集 10 组数据，剔除异常值，系统计算眼轴等参数，执行 IOL 计算，保存结果；
B 超检查：患者闭眼，眼睑涂抹超声耦合剂；B 超探头置于眼睑表面，调节增益获取清晰图像；冻结、存储图像，可回放、标注、测量病灶；
报告打印，检查结束，探头消毒；关闭设备电源，收纳配件。
English
Power‑on: Connect power supply, probes and foot switch, power on. Input patient inｆormation, select A‑scan or B‑scan mode.
A‑scan biometry: Place patient in supine position, apply topical corneal anesthetic. Disinfect A‑scan probe with alcohol. Place probe vertically and gently on central cornea. The system automatically collects 10 groups of data, rejects abnormal values, calculates axial length and IOL power, then save results.
B‑scan examination: Ask patient to close eyes, apply ultrasound coupling gel on eyelid. Place B‑scan probe on eyelid, adjust gain for clear images. Freeze, store, playback, annotate and measure lesions.
Print reports. Disinfect probes after examination. Power off the device and store accessories。
6、适应症 Indications
中文
A 超：白内障术前眼轴、前房深度、晶状体厚度生物测量，计算人工晶体度数；无晶体眼、长眼轴等特殊眼轴测量；
B 超：屈光介质浑浊无法直接眼底观察的患者，检查玻璃体积血、玻璃体混浊、视网膜脱离、脉络膜脱离、眼内异物、眼内肿瘤、眼眶病变、眼外伤等眼球眼眶病变；医疗机构眼科临床检查使用。
English
A‑scan: Pre‑cataract‑surgery biometry including axial length, anterior chamber depth and lens thickness for IOL power calculation; biometry for aphakic eye, long axial eye and other special eyes.
B‑scan: For patients with opaque refractive media preventing direct fundus observation. Detect vitreous hemorrhage, vitreous opacity, retinal detachment, choroidal detachment, intraocular foreign body, intraocular tumor, orbital lesions and ocular trauma. For clinical ophthalmic examination in medical institutions。
7、禁忌症 Contraindications
中文
角膜破损、角膜溃疡未愈合，禁止接触式 A 超探头直接接触角膜；
眼睑皮肤破损、急性眼睑感染，禁止 B 超探头直接接触患处；
眼部急性活动性出血，遵医嘱评估后再开展检查；
不能配合检查的躁动患者，不建议进行接触式 A 超检查。
English
Contact‑type A‑scan probe shall not directly contact cornea with unhealed corneal laceration or corneal ulcer.
B‑scan probe shall not contact damaged eyelid skin or acute infectious eyelid lesions.
Examination shall be perｆormed only after clinical evaluation for eyes with active acute hemorrhage.
Contact‑type A‑scan is not recommended for restless patients unable to cooperate.
8、注意事项 Precautions
中文
本设备医疗机构眼科，由专业眼科医师或技师操作；
A 超探头接触角膜前，必须表面麻醉；探头每次使用前后酒精消毒，严防交叉感染；严禁磕碰探头晶体面；
A 超探头轻触角膜，不可用力按压，防止角膜损伤；
B 超使用合格医用超声耦合剂，禁止耦合剂进入眼内；
设备必须可靠接地；禁止潮湿环境使用，避免液体流入主机；
定期校验设备测量精度；探头属于易损件，出现信号异常及时更换；
不可自行拆卸主机，维修由厂家授权人员执行；
检查数据仅作为临床参考，需结合其他检查综合诊断。
English
This device shall only be operated by professional ophthalmologists or technicians in medical institutions.
Topical anesthesia must be applied before A‑scan probe contacts cornea. Disinfect probe with alcohol before and after each use to prevent cross‑infection. Avoid impact on probe crystal surface.
Gently place A‑scan probe on cornea, do not press hard to prevent corneal injury.
Use qualified medical ultrasound coupling gel for B‑scan; prevent gel entering eyes.
Reliable grounding is required. Do not operate in humid environment, prevent liquid from entering main unit.
Verify measurement accuracy periodically. Probe is vulnerable part; replace in case of abnormal signal.
Do not disassemble main unit; maintenance shall be done by authorized personnel only.
Examination results are for clinical reference only; comprehensive diagnosis should combine other examinations。
9、存储条件 Storage Conditions
中文：环境温度 5℃‑40℃；相对湿度≤80%；无腐蚀性气体、避免阳光直射、防尘防潮，远离强电磁干扰。运输存储避免剧烈震动。 English：Ambient temperature:5℃‑40℃; relative humidity ≤80%. Store in environment without corrosive gas, avoid direct sunlight, dust and moisture; keep away from strong electromagnetic interference. Avoid violent vibration during transportation and storage.
10、说明书核心摘要 Manual Core Summary
中文：RetiWave1000 为眼科 A/B 超声诊断仪，A 超实现眼轴等眼部生物测量，用于白内障人工晶体度数测算；B 超实现眼球眼眶二维超声成像，用于屈光介质浑浊状态下眼内病变筛查诊断。整机由主机、A/B 超声探头、脚踏开关、软件组成，二类医疗器械，仅医疗机构临床使用。操作前做好探头消毒，A 超必须角膜表面麻醉，禁止暴力按压角膜；做好设备接地，定期维护校验。测量结果仅供医师综合判断，不作为诊断依据。 English：RetiWave1000 is ophthalmic A/B ultrasound diagnostic system. A‑scan completes ocular biometry for IOL power calculation for cataract surgery. B‑scan provides 2‑dimensional imaging of eyeball and orbit for intraocular lesion screening especially for eyes with opaque refractive media. It belongs to Class II medical device, composed of main unit, A‑scan/B‑scan probes, foot switch and software, for clinical use in medical institutions only. Probe disinfection is required before operation. Topical corneal anesthesia is mandatory for A‑scan, hard pressure to cornea is forbidden. Ensure reliable grounding and regular maintenance & calibration. Test results are for physician comprehensive reference only, not sole diagnostic basis.
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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