P-TEST One - Nine - Plus
P-TEST series is the new generation of bench-top electro pneumatic equipment for air pressure decay leak and obstruction testing of elastic or rigid medical devices, continuing our 20 years experience in the field of medical device testing solutions for biomedical industry.
Wide range of pressures and test times, advanced technical construction, great leak detection accuracy. These top features, combined with a totally new, user friendly LCD graphic interface, indicate P-TEST series as the best testing equipment for routine tests in production lines, and for product validation and quality assurance purposes.
P-TEST series performs 3 different test types:
Leak Test (Pressure Decay / Leak Rate)
Single Obstruction Test (Pressure Monitor) – only with P-TEST ONE and NINE –
Multiple Obstruction Test(only with P-TEST ONE)
LEAK TEST PRINCIPLES
P-TEST series operates according to the following programmable parameters:
T1p:Pressurization time. The device to be tested is filled with compressed air. The filling valve stays open to compensate for settling down of pressure due to elasticity of the device, preventing pressure drop.
T1s: Stabilization time. The filling valve is closed to allow the final settling of the pressure inside the device. The test pressure is continuously monitored to detect big leaks.
T2: Test time. The pressure decay is measured. Leaks detected during this phase that exceed the set decay limits programmed into the P-TEST at the beginning of testing will be identified as “rejects”.
T3: Discharge. If enabled prior to testing, the air used to test the device is automatically discharged.
Pr: Test pressure. The test starts only if the current pressure in the device is between the value set for ± PL (Pressure Limit)
L.L.: Leak Limit. Admissible pressure decay in the device, during T2. If the pressure decay exceeds the set L.L. limits, the product will be considered rejected (negative result of test).
*1: massive leakage at the beginning of the test, during stabilization time, resulting in a REJECT
*2: decay exceeding the preset limits during test time, resulting in a REJECT
OBSTRUCTION TEST PRINCIPLES (Pressure Monitor) – only with P-TEST ONE –
This test is used to check that the pressure (Pr) stays in-between the two pre-set limits (Pmin and Pmax) in the device under test. At the end of the Stabilization Time (Tstb) if Pr > Pmax, the test result is negative (that is, the product is completely or partially obstructed); if does not reach in the preset time (Tmax), the test will fail anyway (since this means that the device under test has a big leak or it is not correctly plugged onto the test port).
It is possible to set the Obstruction Test to make the P-TEST have continuously flowing air and the test to start automatically on overcoming Pmin, which will avoid the operator to push the start button at each new device to test. This test can also be used on automatic machines as Pressure Monitor: in this case, the compressed air is supplied by the automatic machine and P-TEST has only to measure the pressure on the test port, in the range Pmin – Pmax
SECURITY OF DATA & QUALITY SYSTEM
Before its release to the market, quality and performances are accurately tested on each new P-TEST, together with calibration and certification procedure performed with certified equipment.
International Standards pay special attention to measuring, control and testing equipments. Metrological management of the testing equipment has become compulsory for all companies that manufacture medical devices. Each new P-TEST is provided with a Calibration Certificate with the values measured at seven points of the scale. The calibration is performed by trained personnel and the instrument used to carry out the calibration is a digital readout pressure calibrator, certified and intended for this specific application. International Standards ask for a periodic calibration of the test equipment, which is at least once per year. By taking advantage of Tecnoideal Calibration Service, you can easily comply with these Regulations.
The date of the last calibration performed is stored in the memory and is automatically displayed each time the machine is switched on.
With respects to the security issue, in the new P-TEST all the data and tester settings have a checksum to prevent from accidental loss or damage of saved information. The most important information, such as the calibration values, are saved in double copy. Other new specifications like the Password protection or the Self-Test procedure (for the control, at any moment, of the correct operation of the tester) grant the highest security of use.