Medical Alarm Analyzer System

Overview

A complete system for analysis of medical equipment alarm signals for acoustical compliance with *IEC 60601-1-8 requirements, which is required as part of 510(k) clearance by the FDA.

Like all of the acoustic measurement systems we provide, all components of the MAA system are tested and configured into a fully integrated system, so you can start recording and analyzing data the same day you receive it. We also offer onsite installation of our systems, and our expert support staff is only a phone call or email away.

Read about our Medical Alarm Analyzer software here, and please contact us for more information about MAA systems.

*IEC 60601-1-8:2006 Medical electrical equipment — Part 1-8: General requirements for basic safety and essential performance — Collateral standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems

Components

Trident

Medical Alarm Analyzer

CompactDAQ

G.R.A.S. 46AE Standard

G.R.A.S. Microphone Calibrators

Microphone Accessories

Features

The medical alarm analyzer is designed to analyze WAV file recordings of medical alarm signals in accordance with the requirements of IEC 60610-1-8. WAV file recordings can come from any recording source. However, since audio WAV formal files are inherently uncalibrated, some method of level calibration control must be established. The Medical Alarm Analyzer provides you two ways to establish calibration levels for WAV files.

If the recordings are made using our Trident data acquisition software, then the recordings will contain an embedded normalization terms in the file header that will automatically be read by the Medical Alarm Analyzer and your WAV files will import with calibration levels intact. For more information on out Trident software application, the National Instruments CompactDAQ device and the GRAS model 40PH microphones we would recommend for this application, click on the links associated with each product
For recordings made with a personal computer or dedicated WAV file recording hardware, the best way to establish level calibration is to record a short signal from a sound level calibrator at the same settings to be used for your recordings. The Medical Alarm Analyzer contains a calibration tool that will allow you to specify a calibration file and calibration level, which are used to establish a normalization level for all subsequent recordings.

Medical Alarm Analyzer provides two signal conditioning tools with settings that aid in the time waveform and envelope analysis of the alarm sigansl

High Pass Filtering for alarm signals. Many time alarm signal recordings will contain low frequency noise (rumble) that is not a part of the alarm signal but will affect the time waveform characteristics of the alarm. A High Pass Filter to remove all energy below a user specified frequency will aid in the analysis of recordings with low frequency noise.
Low Pass Filtering for Signal Envelope – The overall envelope of the signal may also have variations that are too fast to perceive and make it more difficult to determine key levels of the signal needed for the time waveform analysis. A user controlled low pass filter can limit these variations in the signal envelope.

The Medical Alarm Analyzer also provides user controlled settings for the type of FFT Analysis Window to be used (normally Hanning, but Flattop and a variety of other windowing methods are supported). In addition, users can specify the detection range, in dB, for harmonic signals in the frequency analysis.

WAV Files are retrieved for each type of alarm (High, Medium, Low and Information are supported) using a standard file browser window. The Medical Alarm analyzer contains logic for automatically detecting the start and stop times of alarm signals that are passing or near passing, and also user controllable time cursors that allow you to visually place the cursors in the time waveform for signals with unexpected time histories.

Services

System Integration

VIacoustics turnkey measurement systems are built in a working acoustics laboratory and are fully assembled, calibrated and tested for plug and play operation when the arrive at your site. This includes assembly of system hardware, installation of drivers and software, system configuration and calibration and providing labeled cables and connectors for full system function on installation.

Onsite Installation & Training

System Support Services

Consulting Services

VIacoustics can offer you a wide variety of acoustic and quality system consulting services that can help you build an acoustic measurement program from a basic sound level measurement to a fully accredited test laboratory. And, we can also help you make your products quieter and sound better to your customers. Here’s just a few of the consulting services we typically provide to our clients.

Acoustic Consulting on Product Noise – Understanding of product specifications, regulatory requirements, test methods, and basic acoustic principals as it relates to your product, equipment, or situation. Many clients who are experiencing acoustic noise emission requirements for the first time need these services just to understand the basics of the technology and the measurements required.

Acoustic Consulting on Acoustic Measurements and Laboratory Design – We’ve been involved in the construction and instrumentation of literally hundreds of acoustic measurement laboratories throughout the world for the past 30+ years. Some were basic acoustic measurement test benches in small companies and some were the largest, accredited test laboratories in the US. We can help you plan for what you need to build an acoustics program in your company that will meet your needs.

Acoustic Consulting for Product Noise Control – Working with David Nelson of Nelson Acoustics, one of the leading noise control consultants and sound quality experts in the US, VIacoustics can offer you acoustic consulting services that will help you reduce, control and engineer the sounds that come from your product to meet regulatory requirements, product specifications or customer acceptance criteria. David employs common sense engineering principals to help you meet your product noise goals. His extensive work in psychoacoustics and sound quality help our customers learn how to make acoustic engineering a product advantage that pays for itself in increased sales and profit margins.

ISO 17025 Quality System Consulting for Acoustics Laboratories – Jeff G. Schmitt, P.E., Principal Engineer for VIacoustics has a strong background and experience in helping acoustics laboratories prepared for accreditation under ISO 17025. He serves as an acoustics laboratory assessor for the US National Institute of Standards and Technology, National Voluntary Laboratory Accreditation Program (NVLAP) and has been trained in the concepts of ISO 17025 quality systems. From his early involvement with the first NVLAP accredited acoustics laboratory in the US, to the US Government and private sector companies he has helped, Jeff has been involved in the accreditation of numerous acoustics laboratories in the US. Jeff takes a very practical and organized approach to developing quality systems that fit the needs of the laboratory, rather it be a small company operation or a large government laboratory.

Pricing

Please contact VIacoustics at for information on pricing.