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Medical Equipment Test Applications
Using the 7000 Precision LCR Meter


Introduction

A medical equipment manufacturer knows full well that a patients health can ultimately depend on their product. This is especially true for implantable devices such as pacemakers or defibrillators. A pacemaker is a device for sensing cardiac activity and is called on to stimulate the heart if and when an interval has elapsed without a sensed beat. A defibrillator is a device which delivers a high voltage shock to the heart in the event of ventricular fibrillation, a condition in which the heart beats very fast and is unable to pump blood. The hearing aid, an electronic device which amplifies sound, also exhibits critical medical equipment characteristics. These are just some of the devices which render themselves to 7000 test applications.


pacemaker

Some of these devices can remain inactive for long periods of time and become activated only during life threatening situations. Therefore, for the components used by the manufacturers of medical devices, it's important that emphasis is placed on miniaturization, reliability and traceability.


Incorporation of Surface Mount Technology

The escalating use of surface mount technology (SMT) is creating special challenges among most, and especially small medical equipment manufacturers. The advantages of SMT in this industry is too overwhelming to ignore: reduced size, enhanced performance, increased reliability and lower cost are just some of the virtues.

A major drawback to SMT technology is the inability of small manufacturers to deal with the assembly and test of small surface mount devices (SMD). For all but the largest companies, the high start-up costs associated with SMT may exclude the possibility of adding elaborate in-house capabilities. The alternative for many manufacturers is shop for subcontractors to help with their circuit board requirements. As an extension of a company's manufacturing process a subcontractor for medical device

manufacturers must comply with certain FDA regulations. Moving the assembly from manufacturer to subcontractor does not remove the burden of assembly and test, it only shifts the burden. In an SMT assembly operation, automated testing is commonplace and a cost effective way of dealing with product in volume. But, even here component misalignment can occur during the soldering process potentially causing opens and short. Also, because many chip components lack identifying marks it is easy for two reels of components to be interchanged. Because of the need for special handling and potential damage to SMT assemblies, central repair stations are often utilized to deal with identified defective product. The bottom line is that there are several opportunities in the overall assembly and test process to improve product and reduce costs through component testing.


Typical 7000 Measurement Applications

Hybrid Assembly
(by Medical Device Manufacturer
or Hybrid Assembly House)

Sample test of devices at incoming inspection - Instills confidence that quality parts are being moved into the manufacturing process.

Spot check of devices on reels on in bins before assembly - Prevents components from being accidentally interchanged and installed in the wrong locations.

Repair Station- Analyze failed product to locate and replace defective components. Ability to program low level ac signal allows in-circuit testing without excitation of other components.

Collect Data - Monitor trends in test results and archive for future reference.

Component Manufacturers for Medical Equipment

Evaluation of New Components - Analyze the functionality of new components, for example: using 7000 sweep function to determine resonant frequency of hearing aid coils.

Production Test - Make sure good components are consistently delivered to the end user.

Setup Storage - Test conditions are easily stored and later recalled so devices can be tested the same way each time.

Battery Manufacturers for Medical Devices

Impedance Measurements of Batteries- Internal impedance and ac resistance measurements to ensure battery quality and longevity.


Most Useful Instrument Features

Swept Parameter Measurements - For component evaluation over a selectable frequency range. Tabular or graphical format on the front panel LCD display.

Menu Programming - Easy to change test conditions and easy to use by different operators, no training needed.

Test Data Collection - Test results can be stored automatically on the built-in floppy drive or transferred to computer for further analysis and traceability.

Setup Storage - Test conditions can be easily stored and later recalled so that devices can be tested the same way every time.

RLC Meter

Connection and Handling of Small Unleaded Devices

One of the difficulties being faced with small components used in medical devices is a means of making reliable contact during test. An accessory available for use with the 7000 Series of meters is a set of chip component tweezers. The tweezers plug directly onto the 7000 and intended for handling of small component as well as a means for making electrical test connection to them. A surface mount component fixture is also available.

tweezers

Other QuadTech Instruments for Testing Medical Devices

Guardian Series of Hipot Testers The hipot test is used to stress insulation to ensure that it can withstand voltages above its normal use. Increasingly popular is the requirement that an insulation test precede and follow any hipot test. is is intended to make sure that the hipot test does not degrade the material under test. The cables, components and circuits used in variety of medical devices often require this type of test in a production or R&D environment.

1865 Megohmmeter/IR Tester - Equally important with medical devices are insulation resistance tests. The transducers, sensors, cables, circuits boards, capacitors and other components often require testing to meet rigid standards or to locate material defects.

The information presented here is subject to change and is intended for general information only


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