3.1 CHEMICALS
All parts of the MAKY have been validated for use with all the chemicals (bleach, peracetic acid, formaldehyde and glutaraldehyde) used in reprocessing regardless of the different brand names. Should a dialysis center decide to switch to a different chemical, the MAKY can be reprogrammed on site, by using an access code that changes daily, and following the instructions of our engineers. Bleach can also be used as the cleaning agent for peracetic acid, as well as for cleaning the system in lieu of using industrial formula 409.
3.2 PERFORMANCE
The aggressiveness of the cleaning cycle improves the reuse numbers of the facility that installs a MAKY. A user friendly interface helps the technician in the daily operations with the consequent operator’s time reduction.
The MAKY has been tested with practically every dialyzer available in the US market, with volume measurement comparisons made against a properly calibrated Renatron®. The MAKY and Renatron® read essentially the same volumes, with less than a 2% variance. The MAKY is also consistent in repetitive testing on the same dialyzer within a 2% factor.
A real difference between both systems is evident only if a dialyzer fails and the “start process” button on the Renatron® is pressed repeatedly in the high flux mode of a large dialyzer. Since the Renatron® uses vacuum pressure to drain the blood side of the dialyzer, and water remains on the dialysate side of the dialyzer, this allows the Renatron® to pull water from the dialysate side and increase the volume with each repetition. The MAKY uses a positive pressure to remove fluid from the blood side during a volume test.
3.3 VOLUME MEASUREMENT METHOD
The MAKY does not use a load cell for volume measurements. It uses hydrostatic pressure, an equally accurate and less maintenance intensive method than trying to weigh small volume fluids. When a volume cell test is done, the MAKY asks the operator to input the known volume of the cell. If the variance is outside parameters of +/- 3 ml, the MAKY will automatically recalibrate, without operator intervention, and repeat the test. The label printer documents the results.
3.4 SCHEDULED PM and 409/BLEACH PROCEDURES
The MAKY will remind the operator on a calendar schedule that a PM or 409 procedure should be performed.
Step by step instructions, for the 409/Bleach Procedure, appear on the LCD that requires acknowledgment before proceeding to the next step. Bleach can be used, in place of 409, for this application. After it is performed, the label printer documents it for the maintenance log.
3.5 CULTURE PROCEDURE
The MAKY menu includes the option to take a culture for testing purposes. The MAKY will go through a flush procedure, leaving only RO water in the volume cell from which the culture may be taken. The label printer documents that a sample has been taken for the maintenance log.
3.6 WATER COMSUMPTION
The MAKY will also use two or three gallons less RO water per reprocessing (12-18 cents per dialyzer) than a Renatron®.
3.7 WATER REQUIREMENTS
Water consumption per dialyzer is approximately 5.5 liters for standard dialyzer programs, to a maximum of 9.8 liters for large high flux dialyzers if the same chemical agents are used for cleaning and disinfection. The maximum flow rate is 3 liters per minute. Recommended water pressure range is 35-50 psi dynamic pressure.
3.8 MAINTENANCE
Reliability testing on the MAKY was done for a 5 year life cycle on all parts with no failures. This was done by repeated cycling, 24 hours a day. This, of course, eliminates the human potential of tinkering and abuse. O-rings will routinely be replaced on, at least, an annual basis. Quarterly PM include visual inspection of the internal O-Rings. The MAKY will self calibrate on each volume check if the built in computer determines so.
3.9 WARRANTY
The MAKY has one year warranty on parts and labor. After the warranty period HDC Medical, Inc will continue offering a 24 x 7 telephone service completely free of charge for EVERY MAKY USER regardless of the chemicals being used.
3.10 TECHNICAL SUPPORT
HDC Medical offers LIFETIME 24 x 7 telephone technical support free of charge. The Inservice of the instrument includes a brief technical training that will cover the basics. Deeper understanding of the instrument may be covered by periodical training schools that HDC Medical will offer. On-demand courses may also be scheduled. The MAKY also has a diagnostics tool in the menu that allows the activation of valves, to observe the function without having to dismantle them. Error codes are displayed on the LCD to quickly reference the nature of the problem. A trouble shooting guide is also included in the software of the MAKY.
The technical support that HDC Medical can offer is not limited to the operation of the MAKY. HDC Medical has 30+ years of experience in the dialysis market. We have worked with several facilities for many years to increase reuse averages. It is an approach that is safe, simple and successful, but requires the nurse manager to “manage” the staff to insure communication among them, generating slow, constant changes in heparin regimens. The most salient point is …. “Proper heparinization is necessary for a good dialysis treatment …. good reuse is simply a fringe benefit.”
HDC Medical is a niche Company that knows our market well. The resources to analyze the dialyzer reuse program are available beginning with the button on the MAKY panel that says “Reports.”
3.11 OPERATOR OSHA REQUIREMENTS (USA)
These requirements are the same as for other reprocessing machines if peracetic acid is used. If formaldehyde or gluteraldehyde are used, proper signage in the area in which it is used must be posted and personnel must wear badges to monitor vapor levels, determine short term and long term exposure levels, or get a time weighted average exposure at least yearly. Annual physical examinations, including chest X-rays, should be performed for personnel working in the designated hazardous area.
AAMI ventilation requirements simply demand that vapor levels in the reuse room be maintained below 1 ppm for hydrogen peroxide, 10 ppm acetic acid, 0.3 ppm for formaldehyde and 0.05 ppm for gluteraldehyde. Any reprocessing area that accommodates these requirements for the other reprocessing machines in the market would certainly be sufficient for a MAKY.
3.12 INTERFACES and STATISTICS
The MAKY will store statistical data without the need of an ancillary computer. Different reports may be viewed on screen or printed through any parallel port printer available in the market. Data concerning individual volumes, total and dated reuse details, total and dated reuse averages for the entire database, a selected range of patients or a specific patient may be analyzed. Totalized information such as averages by dialyzer type, dialyzer brand, discard causes, and monthly details may also be reviewed.
If custom reports and charts are required, the MAKY may export the data to a PC based Reporting Software, MARES.
3.13 IMPROVEMENTS
We will continue to make software changes, based on suggestions from our customers that enhance flexibility and simplify the operation of the MAKY.
The flexibility of the MAKY to adapt to new dialyzers (or hemodiafilters) that may require a different cleaning agent or disinfectant, or require different volumes of cleaning or sterilizing agents, is a virtue that should not go unnoticed.
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