-17-
Instruction Manual
A.
The RENATRON
®
II 100 Series station must be sanitized once each day. Perform the following procedure
at end of reprocessing day
:
1. Ensure that the RENALIN
®
100 container has at least 1" of unexpired RENALIN 100.
2. Connect the
"ARTERIAL INLET"
and
"VENOUS OUTLET"
lines to the calibration cell.
3. Attach the
"DIALYSATE INLET"
line to the
"DIALYSATE OUTLET/SANITIZE INTERLOCK"
connector using the male/male fitting attached to the front of the machine.
4. Wipe clean all external surfaces on the RENATRON II 100 Series station with fresh 1% RENALIN 100 Solution
or full strength Actril Cold Sterilant.
5. Check that the
"VOLUME"
display indicates "SEL" and program mode "00," "CH" or "HF" are displayed in
the
"PROGRAM STEP"
display.
6. Push the
"START SANITIZE"
switch to start the cycle. The machine will automatically sanitize itself.
7. Press machine
"OFF"
switch when the machine cycles to PROGRAM STEP
83
. A
"SANITIZE
COMPLETE"
message will be displayed.
NOTE
– A sanitize holding period of six hours or more will expose the machine's fluid pathways to Proportioned
RENALIN 100 Solution for a time consistent with the disinfection time indicated in the RENALIN 100 Cold
Sterilant labeling. If the "START PROCESS" switch is pressed after entering "PROGRAM STEP" 83, total
sanitize cycle time will be approximately seventeen (17) minutes which includes a 10 minute hold time. This
will sanitize the machine fluid pathways. This cycle will also allow the purging of the RENATRON II 100 Series
system hydraulic pathways for shipping purposes.
8. Turn off water supply to the RENATRON II 100 Series station.
9. If the RENATRON II 100 Series station is not used within 7 days time after sanitize is complete, it should be
sanitized again and allowed to sit for at least 10 minutes prior to use.
IMPORTANT NOTE
THE REPROCESSING MANAGER MUST READ AND ACT ON THE INSTRUCTIONS FOR SETTING UP THE
RENALOG RM PROGRAM BEFORE NORMAL ONLINE USE OF THE SYSTEM IS ATTEMPTED. THERE IS
A SEPARATE RENALOG RM INSTRUCTION MANUAL P/N: 50090-859.
A.
General Considerations and Cautions
CAUTION
– MEDIVATORS STRONGLY RECOMMENDS THAT ANY HOLLOW FIBER DIALYZER
REPROCESSED BY THIS MACHINE ACCORDING TO THE INSTRUCTIONS IN THIS MANUAL, BE USED
ONLY BY THE PATIENT WHO ORIGINALLY USED THE DIALYZER.
1. When the RENATRON II 100 Series station is not in use, the
"ARTERIAL INLET"
and
"VENOUS
OUTLET"
lines should be connected to the Calibrated Volume Cell. The
"DIALYSATE INLET"
line
should remain attached to the male/male fitting on the
"DIALYSATE OUTLET/SANITIZE INTERLOCK"
connector.
2. At the end of each day the operator should sanitize each RENATRON II 100 Series station. The
"SANITIZE"
cycle sanitizes the machine and prepares it for overnight storage.
3. RENALIN 100 Cold Sterilant and its diluted versions are sensitive to direct sunlight. The RENALIN 100
Cold Sterilant storage carton can be used to hold the RENALIN 100 containers and reduce the light exposure
of RENALIN 100 Cold Sterilant. Before using the RENATRON II 100 Series station each day, ensure that:
a. The RENALIN
100 Cold Sterilant has not passed the expiration date marked on the RENALIN 100
container.
b. The RENALIN 100 container will hold sufficient RENALIN 100 Cold Sterilant to reprocess
approximately 77 dialyzers (low flux and mid-range programs), or 50 dialyzers (high flux program).
4. Prior to the removal of the dialyzer from the blood circuit, the operator must ascertain that all identification
and information on the dialyzer is legible and current (Section 13, part I).
5. After storage and prior to preparation for use, a sample of fluid should be removed from the dialyzer and
tested for the presence of RENALIN 100 solution using the RENALIN 100 presence test procedure and
PERASSAY 500
®
Peracetic Acid Indicator Test Strips (PN 78378-000). The RENALIN 100 presence test
procedure is described in the RENALIN 100 Cold Sterilant Instructions for Use, (PN 50090-679).
Daily
Machine
Sanitize
Procedure
Operating
Procedures
