INCU™ II Incubator Tester

Yes, Test Groups will complete automatically. HOWEVER, before you create a test group, it is highly recommended that you go through each test and understand what the test will require from you (the user). For example, if a test group is created and includes the Inside Alarm level, the device will not automatically carry out the test; you need to be there to manually turn on the alarm to get a reading for the test. Another example is airflow; to measure airflow properly, a reading must be taken from the center and each quadrant thus requiring the airflow probe to be moved about the environment. This means that with certain tests, the device cannot be simply placed into the test environment and left alone for several hours; interaction is needed with both the device and DUT for the INCU II to complete the test and continue through the Test Group. Read through the tests beforehand to ensure you understand what is required from you as the user to avoid this.

A great solution is to create two test groups one with all the tests you need to perform that require your interaction with the device, and the other with the tests that are hands-free and allow you to perform other activities while it is testing. It might be beneficial to group all temperature tests into one Test Group, to avoid disturbing the test environment as much as possible.

No. The placement pad is merely a guide to help you correctly place the INCU II device in the center and probes in the center of the four quadrants of the mattress. The pad is an average mattress size, so if the mattress of the incubator/radiant warmer in your facility is not the exact size, the pad will not tell you EXACTLY where the center is but it serves as a guide. There are detailed instructions in the User's Manual to find the center and center of each quadrant, but you will find that the placement pad is helpful and intuitive to use.

The placement pad is a microfiber cloth it is not antimicrobial. Whenever an incubator or radiant warmer is tested or serviced, it should be thoroughly cleaned and sanitized before being used by a patient again, so sanitizing the placement pad or INCU II device before or after each use is not necessary.

The General Testing option is a highlighted feature of the INCU II. The General Test option is basically a data-logging mode; any probe that is plugged in be it a temperature probe(s), pucks, airflow, sound, humidity, etc. and every combination thereof the INCU II will take continuous measurements until you stop the test. With this option, you can complete a test in 15 minutes (after STC has been achieved) or up to 48 hours.

The General Test gives you the freedom to do perform non-standards based testing that is specific to your facility; you can create a unique protocol specific to your needs. Another great example of using the General Testing is to do a "quick test" of the incubator/radiant warmer after it has been serviced, to ensure all parameters are within range in a quick manner.

After the initial "stabilizing" period of the airflow probe, the INCU II will then display the airflow measurement. If the airflow inside the test environment is at or over 2.1 m/sec, the INCU II will display "OL", meaning the airflow is above the outer limit. Keep in mind that according to IEC 60601-2-19, 2-20, and 2-21 standards, an acceptable airflow measurement is at or below 0.35 m/sec.

There are two models available: Non-wireless (4722635) and Wireless (4722620). Wireless is not available in all countries, and some customers specifically request non-wireless for their facility, so a non-wireless version was made available. Although a non-wireless unit can be upgraded to a wireless version if desired and permitted in your country, wireless cannot be "turned off" once it is activated. Thus the need for two different models.

The IEC standards reflect the best experience of the industry, researchers, consumers, and regulators worldwide. The standards help establish a universal and uniform testing procedure for biomedical/clinical, service, and design engineers to use, and are critical in helping properly assess the safety of medical devices and ensuring patient safety¹. The procedures called out in the testing/service manuals of many medical device manufacturers are often built around these standards. The INCU II was specifically designed around the IEC 60601-2-19 (incubator), 2-20 (transport incubator) and 2-21 (radiant warmer) testing standards.

Minimize risk, maximize patient safety. Test to the standards. To learn more about the standards, visit http://www.iec.ch/about/activities/standards.htm¹

If a probe is found out of spec, we replace the probe/puck with a new probe/puck and perform verification again.