The MAKY functions without an ancillary computer. All components, keyboard, bar code scanner, label printer and reports printer, plug directly into the rear of the MAKY. Pressing any program button on the MAKY arms it to read the next bar code scanned, or allows the manual input of a dialyzer number. The LCD will ask for confirmation of the patient shown, requiring a reply by pressing the yes button (or choosing an extended cleaning option) or choosing “reset” to return to the previous screen to make another selection.
The cleaning program is very aggressive, using hydro pneumatic agitation and pulsatile reverse ultrafiltration. It will use either bleach or peracetic, both diluted by the MAKY from a 100% original concentration.
A volume test is then performed. The menu allows setting the volume requirement at any level above 80% of original or expected volume as a permanent setting, not one that would change from dialyzer to dialyzer, but can be changed again if standards change. There is a “preprocess option” in the menu that determines original volume. If a dialyzer fails the volume test, the MAKY automatically fills the dialyzer with water again and repeats the volume test. If it fails again, the menu options are repeat test, reprocess again, preclean or discard.
Following the volume test a MIT (membrane integrity test) is then performed, generating 300mmHg of positive pressure on the blood side of the dialyzer, while the dialysate compartment is left open to atmosphere. The allowed pressure drop is 0.83mmHg/s +/- 10% (STD/HE), or 1.25 mmHg/s +/- 10% (HF). If the test fails, the MAKY repeats it automatically. If it fails a second time, the option is given to repeat the test (useful only if corrective action is taken) or discard the dialyzer. Since the MAKY uses positive pressure on the blood side of the dialyzer for the MIT, it will detect both blood leaks and damaged dialyzer casings.
If both tests are passed, the system then inputs the germicide at the concentration required. MAKY uses undiluted peracetic acid, and formaldehyde, but Glutaraldehyde is required to be used diluted to its use dilution. The MAKY will print labels for dialyzer identification (ID-bar code), reuse performance (INFORMATION), and preclean data.
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