LED频闪观测灯用于医疗器械的目视检查

数字LED频闪观测灯极大地方便了心血管医疗器械在加速疲劳时的目视检查。频闪观测灯是检测设备故障和跟踪测试过程中运动的非常有用的工具。加速疲劳是许多心血管医疗设备（如支架、心脏瓣膜和刺激器导线）的常见测试方法。心血管器械加速疲劳试验的行业标准包括 ASTM F2477、ISO 5840-3 和 ISO 25539-1。在加速疲劳测试期间，样品通常运行 400 或 6 亿次循环，以模拟 10 或 15 年的器件生命周期。

LED Stroboscope Visual Inspection of Medical Devices

Digital LED stroboscopes greatly facilitate visual inspections of cardiovascular medical devices as they undergo accelerated fatigue. The strobe light is a very useful tool in detecting device failures and tracking motion during testing.Accelerated fatigue is a common test method for many cardiovascular medical devices such as stents, heart valves, and stimulator leads. Industry standards for accelerated fatigue testing of cardiovascular devices include ASTM F2477, ISO 5840-3, and ISO 25539-1. During accelerated fatigue testing, samples are typically run for 400 or 600 million cycles to simulate 10 or 15 device lifecycle years. 

测试期间的目视检查

作为测试协议的一部分，检查通常在测试前、测试中和测试后的不同阶段进行。测试期间执行的检查分为两类：在测试仪和不合格。试验机外检查包括暂停测试、取出样品并在显微镜下检查，然后再将其送回试验机。在测试人员检查期间执行，或者在设备仍保留在测试系统上时暂停测试后执行。

如果测试暂停，可以借助背光、手持式显微镜或内窥镜进行目视检查。然而，当设备静止时，有时很难检测到故障和小断裂。测试运行时使用的两种常用检查方法是频闪观测灯和高速视频。在本文中，我们将重点介绍使用频闪观测灯进行高频测试仪检测的好处。

Visual inspections during testing

Inspections are routinely performed as part of the test protocol at different phases including pre-, during, and post-test. Inspections performed during testing fall into two categories: on-tester and off-tester. Off-tester inspections involve pausing the test, removing a sample and examining it under a microscope before returning it to the tester. On-tester inspections are performed either while the test is running or after pausing the test while devices remain on the test system. 

If the test is paused, visual inspections can be made with the aid of a backlight, handheld microscope, or an endoscope. However, it is sometimes difficult to detect failures and small fractures when the device is stationary. Two popular inspection methods used while a test is running are stroboscope and high-speed video. In this article, we will highlight the benefits of using a stroboscope for high-frequency, on-tester inspections.

频闪观测灯的工作原理

频闪观测灯，也称为频闪仪、频闪灯或频闪转速计，是一种用于产生规律闪光的设备。在测试过程中，闪光可以停止或调整运动的状态，从而使用户能够直观地检查以高频运动的设备。当频闪的频率调整为与测试频率同相时，被摄体将看起来静止不动。频闪观测灯频率与测试频率的相位越差，运动出现得越快。

如果运动看起来太慢或太快，则可能很难识别设备中的变化并检测故障。当调整频率以使运动的外观与生理频率大致一致时，频闪观测灯的使用最有效，通常在 1 到 2 Hz 之间。关闭室内灯可减少光线干扰，并可以进一步提高能见度。FDA 发布了一份参考文件，指导使用频闪观测灯进行目视检查。

How the stroboscope works

A stroboscope, also called a strobe light, stroboscopic lamp or strobe tachometer, is a device used to produce regular flashes of light. The flashes of light can stop or adjust the appearance of motion during testing, which allows users to inspect devices moving at high frequencies visually. When the frequency of the strobe light flash is adjusted to be in phase with test frequency, the subject will appear still. The more out of phase, the strobe light frequency is with the test frequency, the faster the motion will appear.

If the motion appears too slow or too fast, it can be hard to identify changes in the device and detect failures. Strobe light use is most effective when the frequency is adjusted so that the appearance of motion is approximately aligned with physiological frequencies, typically between 1 and 2 Hz. Turning off room lights reduces light interference and can further improve visibility. The FDA published a reference document guiding the use of stroboscopes for visual inspection. 

使用频闪观测灯检查支架、心脏瓣膜和刺激器导线

我们的心血管设备检测实验室通常对以下测试和设备进行频闪观测灯目视检查：

支架和支架片的 S/N 疲劳测试

支架和导线的动态弯曲测试

大支架/移植物检测

心脏瓣膜修复组件检测

其中许多测试在高频下运行，通常在 40 至 70 Hz 范围内，频闪观测灯对于 30 Hz 以上的测试频率最有用。

Inspecting stents, heart valves and stimulator leads with strobe light

Our cardiovascular device testing lab commonly performs stroboscope visual inspections for the following tests and devices:

S/N fatigue testing of stents and stent coupons

Dynamic bend tests for stents and leads

Large stent/graft testing

Heart valve repair component testing

Many of these tests run at high frequencies, often in the 40 to 70 Hz range, and the strobe light is most useful for test frequencies above 30 Hz. 

有氧运动设备的频闪镜目视检查

频闪观测灯是一种相对便宜的工具，用于加速疲劳测试，用于检测以下内容：

失败

骨折

支架移位和贴位丧失

微动痕

松散的压接

夹具和设备运动

裂缝会在设备中产生空间，当设备处于运动状态时，可以更容易地检测到该空间;事实上，这些断裂需要更长的时间才能看到系统何时停止。

除了断裂和故障外，频闪观测灯检测还经常用于运动验证。可以随着时间的推移评估和监测均匀的装置运动，以确保没有发生不需要的运动。例如，在二尖瓣系绳的轴向疲劳试验期间，可以跟踪和验证系绳与连合运动的附着。

测试波形形状的变化或负载测量值的减少可能会触发频闪观测灯检查，以确定问题的根源，这可能与设备、夹具或仪器有关。频闪观测灯检查需要非常少的准备工作，并且可以轻松地每天或每周进行一次。

A strobe light is a relatively inexpensive tool used during accelerated fatigue testing to detect the following:

Failures

Fractures

Stent migration and loss of apposition

Fretting marks

Loose crimps 

Fixture and device motion

Fractures create space in the device that can be more easily detected when the device is in motion; in fact, these fractures would take much longer to see when the system is stopped.

In addition to fractures and failures, strobe light inspections are often used for motion verification. Uniform device motion can be assessed and monitored over time to ensure that no undesirable motion is occurring. For example, during axial fatigue testing of a mitral valve tether, tether attachment to the commissure motion can be tracked and verified.

Changes in the test waveform shape or a reduction in load measurements may trigger a strobe light inspection to identify the source of the issue which could be device-, fixture- or instrument-related. Strobe light inspections require very minimal preparation and can easily be performed on a daily or weekly basis.

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