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Instruction Manual
E.
Environmental Limits:
The RENATRON
®
II 100 Series
is designed to be safe for indoor use at temperatures from 5˚C (41˚F) to 40˚C
(104˚F), maximum relative humidity of 80% at 31˚C (87.8˚F) decreasing linearly to 50% relative humidity at 40˚C
(104˚F). The supply line voltage fluctuations may not exceed ±10% of the nominal voltage.
F.
Water Requirements:
1. Flow
a. Feed line flow 0.46 gallons per minute (1.75 liters/minute) average pressure at 20-55 psig (137.9 - 379 K
Pa, 1.38 - 3.79 Bars) per RENATRON II 100 Series station.
b. Peak flow rate is approximately 1.6 gallons per minute (6 liters/minute) per RENATRON II 100 Series
station. This peak flow is 15-35 seconds in duration and occurs at approximate three (3) minute intervals.
2. Water must meet quality requirements listed in the current versions of the ANSI/AAMI Standard for Hemodialysis
Systems and ANSI/AAMI Recommended Practice for Reuse of Hemodialyzers. It must meet both endotoxin
and bacterial specifications listed in the current version of the ANSI/AAMI Recommended Practice for Reuse
of Hemodialyzers.
3. Inlet water must be filtered to particle size not larger than 1 micron.
4. Temperature must be in a range of 59˚F - 75˚F (15˚C - 24˚C).
5. Static (no flow) pressure should not be in excess of 55 psig (379K Pa, 3.79 Bars). For optimal performance
adjust the pressure to 30-35 psig dynamic output pressure while all RENATRON II 100 Series are operating
in step 04 and all the other equipment on the same water system are in operation.
G.
Drain
:
The drain must be capable of accepting a minimum water flow of 1.6 gal/min. (approx.
6 liters/minute) per RENATRON II 100 Series station. Optimal placement is at counter top level, and the drain
should be placed no higher than the top of the machine. Sanitary drain connections must be used in accordance
with state and local plumbing codes. Drain must be vented to atmosphere. Drain piping should be made from PVC,
CPVC or other corrosion resistant materials.
H.
Dialyzer Testing:
The RENATRON II 100 Series station performs a blood compartment (priming) volume measurement, and a
pressure leak test on each dialyzer.
1. Header Leak Test - The RENATRON station will perform a header leak test, between program Step 2 and 3.
If a "Pressure Fail" message appears in Step H-2, verify that the blood port connections are secure and that
the dialyzer header caps and O-rings are properly placed. This test can be repeated indefinitely by pressing the
"START PROCESS" switch. If the "pressure fail" message re-appears after the blood port connections and header
cap and O-ring placement has been verified, the "RESET" switch should be pressed to fail the dialyzer. This
error message is exactly the same error message as in program Step 39 and will fail the dialyzer for "pressure".
Therefore, the operator should keep track of the step in which the error occurred.
Note: The header leak test is only available on model RS-8335 RENATRON II 100 Series
with 32650-022 flash
memory.
2. Blood Compartment (Priming) Volume Measurement - The RENATRON II 100 Series measures, displays
and holds each reprocessed dialyzer’s blood compartment volume with a repeatability of ± 5%, typically
within 5.0 ml of true volume. If this volume is less than the blood compartment reference volume (selected by
prescribing physician) the dialyzer fails the volume test.
3. Volume Fail - The RENATRON station will only allow a dialyzer to be re-tested two times after it initially
fails the volume test during the reprocessing cycle.
If a "volume fail" message appears, press the "START PROCESS" switch to repeat the test. After the initial
"volume fail" message appears, the test may only be repeated two more times. After the third "volume fail"
message appears, the "START PROCESS" switch will be deactivated and you must press the "RESET" switch
to fail the dialyzer.
NOTE: Older versions of model RS-8330 RENATRON station will allow the dialyzer to be retested
indefinitely but MEDIVATORS recommends that a dialyzer be retested for volume no more than twice.
4. Pressure Leak Test - The dialysate compartment of each dialyzer is subjected to a minimum of
250 mmHg negative pressure while the blood compartment remains at atmospheric pressure. A dialyzer that
loses pressure at a rate equal to or greater than 0.83 mmHg ± 10% per second fails the pressure leak test (low
flux - 00 and mid-range CH programs). A dialyzer that loses pressure at a rate equal to or greater than 1.25
mmHg ± 10% per second fails the test for the high flux (HF) program.
