Epinephrine Injector

Sudden allergic reactions can be life-threatening; and treatment must be administered immediately and properly.  Often used to treat severe cases, the epinephrine injector is a medical device for administering a dose of adrenaline by means of auto-injection technology. Proper use of the pen is guided by a series of audible beeps and scripts, supported by circuit board technology.

Avoiding Quality Issues

As with any medical device or equipment, quality is non-negotiable. Epinephrine injectors are subject to strict FDA guidelines and regulations; and product flaws can open the door for costly recalls and/or litigation. As a precaution, a leading electronics supplier implemented a Signalysis quality inspection system to detect anticipated flaws including:

• Beeps at the wrong frequency
• Scripts playing incorrectly and/or at the wrong time
• The playing of a wrong language
• Script that are indistinguishable or too loud/soft

Solution

Signalysis designed and developed a test system customized to the supplier’s requirements and budget. Powered by Signalysis SigQC software, the system utilizes a database of good wave files for specific words in each script. Spectral information from the specific words of the good wave files is accessed and saved.

Two separate test stations allow the manufacturer to perform multiple tests along the same line. At one stop, injectors are tested for Beeps. Further down the line a second station tests Scripts. This flexibility of Signalysis test systems to perform multi-station inspections is shown to accelerate tact time significantly.

• The Beep station inspects each injector for frequency, dB(A) and beep count.
• The Script station tests injectors randomly. Three separate scripts and three words are inspected. The percent match to the database of good wave files, the dB(A) level of the match, and word count for each script are checked. False failures are added to the database so future similar units will pass. This is repeated for all languages supported by the epinephrine injectors.

SIGQC

Signalysis SigQC software drives the process. SigQC analyzes components, subassemblies and products to determine, in real-time, if quality goals are met. The system can be integrated into existing manufacturing lines providing a completely automated inspection solution.

Results

With an accurate and objective quality assurance solution, the manufacturer can proceed with confidence knowing that circuit boards will consistently meet the industry’s highest quality standards. Since implementing the system, the manufacturer, along with others in the industry, have turned to Signalysis to deliver additional automated and objective-based product quality test solutions.