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Instruction Manual
3. Materials for interconnection of the RENATRON
®
II 100 Series System:
a. RENATRON II 100 Series station to Interface Module communication cable(s)
b. Computer to Interface Module communication cable (1 ea.)
c. Computer to Printer communication cable (2 cables)
4. Materials for connection of the RENATRON II 100 Series station to existing in-house water supplies consisting
of:
a. Water pressure gauge block for attachment between one or two RENATRON II 100 Series stations and the
water outlet from the dialysis center. Mounts on the drip tray.
b. 1-6' water hose with a female Hansen type connector and a check valve for attachment to the water gauge
block and a 3/4 inch female garden hose connector for attachment to the dialysis center water outlet.
c. 1-6' drain hose for each RENATRON II 100 Series station.
5. One volumetric calibration cell for periodic checking of the RENATRON II 100 Series operation.
6. Drip Tray - single or dual RENATRON II 100 Series compatibility.
B.
Terminology
: For the purpose of clarity, the following terminology will be used throughout this manual.
1. "Water" or "AAMI quality water" is water that meets or exceeds the following requirements:
a. AAMI/ANSI Standard for Hemodialysis Systems and AAMI Recommended Practice for the Reuse of
Hemodialyzers.
b. Containing no particles larger than 1 micron.
2. "RENALIN
®
100 Cold Sterilant" or "RENALIN 100" is a concentrated solution for use with the RENATRON
II 100 Series System. It is supplied as 3 liters of RENALIN Cold Sterilant in a 1 gallon container for use by
the RENATRON II 100 Series machine and for use in making a 1% RENALIN 100 mixture.
3. "Proportioned RENALIN 100 Solution" is the final diluted solution, which has been proportioned by the
RENATRON II 100 Series machine. This is the solution actually used for cleaning and sterilizing the dialyzer.
4. "1% RENALIN 100 Solution" - 1 part RENALIN 100 Cold Sterilant to 99 parts AAMI quality water.
5. The terms equipment, machine, device, station or RENATRON II 100 Series are synonymous with each
RENATRON II 100 Series Dialyzer Reprocessing unit of the overall RENATRON II 100 Series system and
may be used interchangeably throughout this manual.
NOTE – ALL TIMES AND FLOW RATES SPECIFIED IN THIS MANUAL ARE APPROXIMATE.
C.
General System Operation
: The RENATRON II 100 Series is an automated system for rinsing, cleaning, and
testing of hollow fiber dialyzers and for delivery of Proportioned RENALIN 100 Cold Sterilant solution to the
dialyzers. The RENATRON II 100 Series System can also perform record keeping for a dialyzer reprocessing
operation. The RENATRON II 100 Series can be operated in a manual mode by the operator or in an automatic
mode controlled by the RENALOG
®
RM Data Management System. In the manual mode the operator enters a
predetermined (priming) volume into the machine and enters the pre-selected program mode for the dialyzer being
reprocessed. If the RENATRON II 100 Series is being controlled by the RENALOG RM Data Management system,
the predetermined (priming) volume for the selected dialyzer and the required program mode are automatically
set on the RENATRON II 100 Series by the computer using data stored in the RENALOG RM data base. Record
keeping for reprocessed dialyzers can be accomplished by manual data entry from the computer’s keyboard or by
scanning the bar code labels on the dialyzer, RENATRON II 100 Series and user authentication label with the bar
code scanner.
After rinsing and cleaning the dialyzers, the RENATRON II 100 Series
compares the blood compartment filling
volume (priming volume) against the predetermined volume set manually or automatically into the machine. The
machine also conducts pressure leak tests on the dialysate compartment of the dialyzer. If either the blood compartment
volume test or the pressure leak test is unsatisfactory, the machine will automatically stop functioning and activate
audible and visual alarms. When the automatic record keeping operation is functioning and the RENATRON II 100
Series is reset, the RENALOG RM Data Management system will record the actual volume measured, the volume
test pass or fail and the pressure test pass or fail into that dialyzer’s file record, and it will print new labels for the
dialyzer.
The RENATRON II 100 Series stations use RENALIN 100 Cold Sterilant as the only chemical needed to reprocess
dialyzers. THE QUALITY OF WATER USED TO SUPPLY RENATRON
II 100 SERIES STATIONS MUST
EQUAL OR EXCEED REQUIREMENTS LISTED IN SECTION 5, SPECIFICATIONS. The RENALIN 100
Cold Sterilant used by the RENATRON II 100 Series can cause a pressure build up within the machine and/or the
dialyzer under certain conditions. To prevent this possible pressure build up, the RENATRON II 100 Series will
automatically perform a venting operation every 10 seconds after filling the dialyzer with Proportioned RENALIN
100 Solution.
