baxter ExtraPure User manual

157-1232-999 March 2003
OPERATOR’S MANUAL
ExtraPure Reverse Osmosis System

WARNINGS AND CAUTIONS
As used in this manual, the term WARNING is used to indicate a condition that could
cause injury to a person. The term CAUTION indicates a condition that could cause
damage to the machine.
WARNINGS
After installation, the ExtraPure RO System must be sanitized and rinsed before using it
to supply water for dialysis.
Do not operate the ExtraPure RO System with the water quality needle in the red zone.
With a regular dialysis regimen, sanitize the ExtraPure RO System at least once a
week, or as your physician recommends.
Whenever the ExtraPure RO System will not be used for seven days or more, it should
be stored with formaldehyde disinfectant solution in the fluid path. Follow the steps for
"Sanitizing" in the Operator's Manual. Always rinse the ExtraPure RO System and test
for disinfectant before using it to supply dialysis water.
The disinfectant port cover must be securely in place before turning on the ExtraPure
RO System to guard against backsplash. Remember to replace the cover after
injecting the sanitizing agent.
CAUTIONS
If the ExtraPure RO System is operated with the water off, the pump will shut down.
The filter should be changed whenever the product water is below AMMI Standards, the
difference between the front panel pressure gauges is greater than 10 psi, after 65
hours of operation, or as recommended by your dialysis clinic.

CONTENTS
INTRODUCTION............................................................................................... 1
Operation Overview................................................................................ 1
Water Quality Chart ................................................................................ 3
Operator's Controls................................................................................. 5
Flow Diagram Component Identification................................................. 7
Specification ........................................................................................... 8
STARTUP ......................................................................................................... 9
Water Supply .......................................................................................... 9
Unpacking............................................................................................... 9
Installing ................................................................................................. 10
Initial Rinse ............................................................................................. 11
Normal Operation ................................................................................... 13
Cleaning the Membrane ........................................................................ 14
Filter Replacement ................................................................................. 14
SANITIZATION AND STORAGE PROCEDURE............................................... 16
Sanitizing a Hydrogen Peroxide / Peroxyacetic Acid Disinfectant
Compatible RO ....................................................................................... 17
Rinsing ................................................................................................... 19
MAINTENANCE ................................................................................................ 20
Recommended Tools to Maintain One ExtraPure RO ............................ 20
Inspection for Leaks ............................................................................... 20
External Cleaning ................................................................................... 20
TROUBLESHOOTING ...................................................................................... 21
Alarms .................................................................................................... 21
Electrical................................................................................................. 21
Flow........................................................................................................ 22
Pressure ................................................................................................. 23
Water Quality.......................................................................................... 23
Calibration of Electronics........................................................................ 25
Replacing the RO TFC Membrane ......................................................... 25
Pressure Adjustments for Hydrogen Peroxide / Peroxyacetic Acid
Compatible System ................................................................................ 27
Pressure Adjustments for Formalin™ Compatible System..................... 28
Conductivity Cell Connections ................................................................ 29
DIAGRAMS AND SCHEMATICS ...................................................................... 30

1
INTRODUCTION
The ExtraPure Reverse Osmosis (RO) System supplies high-quality dialysis water to
hemodialysis machines. Impurities in dialysis water could diffuse into the blood inside
an artificial kidney, so water used to make dialysate must be as pure as possible. The
reverse osmosis membrane is designed to allow water molecules across and leave
impurities behind.
Operation Overview
As illustrated in Figure 1 on page 2, the ExtraPure RO system uses an incoming water
filter, a heat exchanger, a reverse osmosis membrane, and two recirculating water
loops.
The filter removes solid particles and chlorine from the feed water before it
reaches the RO membrane.
The heat exchanger warms the incoming water, which increases pure water
production and reduces energy use.
The reverse osmosis membrane removes bacteria, inorganics, and pyrogens.
The product water loop feeds surplus pure water back to the RO membrane.
The high-volume loop keeps the RO membrane flushed.
The ExtraPure RO System can produce more pure water than is needed for single-
patient dialysis. Instead of wasting surplus pure water down the drain, recirculation
saves this water and recycles it to improve the quality of the water feeding the RO
membrane.
The ExtraPure System monitors water quality and regulates water pressures and drain
flows. Constant adjustments are not necessary, and the operator can devote full
attention to dialysis.

2
Figure 1: ExtraPure RO System overview

3
Water Quality Chart
Move the selector switch and read the water quality meter. Find the chart column
closest to the actual meter reading and read down for the conductivity in microsiemens
(µS/cm) and approximate total dissolved solids (TDS) in parts per million (ppm) or for
percent rejection.
PRODUCT WATER
meter 2 2.5 3 4 5 6 7 8 9 10
conductivity
(µS/cm)
126 49 31 17 12 9 8 6 6 5
approximate
TDS (ppm)
85 33 21 12 8 6 5 4 4 3
% REJECTION
meter red yellow green
% rejection below 80% 80%-89% 90% and greater
RECIRCULATION WATER
meter 1.5 2 3 4 5 6 7 8 9 10
conductivity
(µS/cm)
1451 871 484 335 256 207 174 150 132 118
approximate
TDS (ppm)
980 588 327 226 173 140 117 101 89 79

4
Figure 2: Rear view of RO unit

5
Operator's Controls
The filter inlet and filter outlet pressure gauges monitor the water pressure on both sides
of the incoming water filter. The pressure difference between the two gauges should
always be less than 10 psi. If the pressure difference is greater than 10 psi, the filter
must be changed.
The water quality meter monitors the quality of the water on the inlet and outlet side of
the reverse osmosis membrane and thus monitors the integrity of the RO membrane.
The green zone of the meter indicates that at least 90% of all dissolved solids are being
rejected by the RO membrane. The yellow zone shows 80 to 89% rejection. Less than
80% rejection (red zone) indicates that the reverse osmosis membrane needs to be
replaced.
WARNING:
Never operate the ExtraPure RO System with the needle in the red zone.
The three-position selector switch allows the meter to display the water quality of either
the recirculating water or the product water. Consult the water quality chart to
determine conductivity in microsiemens (µS/cm) and total dissolved solids in parts per
million (ppm).
The low water pressure alarm will activate when the incoming water pressure drops
below 5 psi. The product water alarm indicates that the output water to the dialysis
system has a conductivity of more than 118 µS/cm. The percent rejection alarm (needle
in the red zone) indicates that the RO membrane rejection is less than 80% and the RO
membrane may need replacement. Audible alarms can be silenced with the alarm mute
button. Also on the operator's control panel are the ON/OFF switch, the rinse lever, and
the sanitizing agent injection port.

6
Figure 3: RO Flow Diagram

7
Flow Diagram Component Identification
Component Purpose
Solenoid valve Opens to allow water to enter the RO. Closes when the unit is turned
off. It ensures that the disinfectant used in disinfecting the unit remains
inside the instrument until it is turned on again.
Water pressure
gauges
Located before and after the water filter. When the difference between
the two gauge readings is greater than 10 psi, the filter should be
changed.
Filter Contains both a fiber material (5-10 micron) and activated carbon. The
carbon is sufficient for 13 treatments (for the home, about one month) if
the incoming water contains less than 3 ppm chloride ions. For higher
chloride levels and chloramines, additional activated carbon may
be needed.
Heat exchanger Tubing around the pump motor to cool the motor and warm the water.
This is done so the motor can be enclosed in insulation without
overheating and warmer water assists the membrane in producing
quality water.
Water pressure
regulator (20 psi)
Regulates the water pressure to the Procon pump at 20 psi.
Sanitize Luer port Used to inject disinfectant into the RO for sanitizing the machine.
Sanitize check valve Prevents back up of water or disinfectant through the sanitize Luer port.
Water pressure
switch
Set at about 6 psi. Should the incoming pressure drop below this
amount, the Procon pump will be shut off and an alarm will sound.
Thermistor Used to monitor the water temperature. This information is used in
conjunction with the two conductivity cells to determine the total ion
concentration of the recirculating and product water.
Conductivity cells Used to measure the conductance of the recirculating and product
water. This information is combined to yield the display of percent
rejection on the front panel.
Procon pump Pump used in RO to push the water across the membrane. The pump
can produce pressures much higher than the 200 psi which is
necessary in the RO.
RO module Contains the thin film composite (TFC) membrane, which is the heart of
the system.
Test points Plugged holes in the system's flow block, which can be used by service
personnel to test pressures and set the pressure regulators.
Pressure regulator
(200 psi)
Provides the backpressure necessary for the Procon pump to create
the 200 psi required to push water across the membrane.
Flow regulator A restrictor used to limit the flow of water to the drain during normal
function. The drain flow is about 1000mL/min.
Fast rinse valve Opened to create a high flow to drain when rinsing disinfectant from the
system. This reduces the waiting time before the unit can be used.
Check valve
(product line)
Used to prevent incoming or recirculating water from entering the
product line. Because this valve is 1 psi, the output water pressure will
be 21 psi to the dialysis machine.

8
Specifications
Name ExtraPure Reverse Osmosis System
Electrical supply 117 VAC 60/50 Hz or 230 VAC 60/50 Hz,
580 W, 6.5 A/3.3 A
Incoming water supply pressure 20-100 psi (138-690 kPa)
Filter 5-micron carbon filter (P/N 407-8502-014)
Maximum water hardness without
softening
Depends on pH of feed water
Membrane configuration Spiral wound
Membrane material Thin film composite -- polyamide
Membrane pH tolerance of input water 3.0- 10.0
Operating temperature, minimum output
of 500 mL/min
5ºC to 35ºC (41ºF to 95ºF)
Rated output at 25ºC (77ºF) input water
temperature
500 - 1,100 mL/min minimum
Rated output at 5ºC (41ºF) input water
temperature
525 mL/min minimum
Size unit Depth - 406 mm (16")
Width - 406 mm (16")
Height - 710 mm (28")
Weight 27 kg (60 lb)
RO membrane operating pressure 200 psi (1,380 kPa)
Membrane integrity/conductivity monitors Dual cell conductivity temperature
compensated, show % rejection and
absolute conductivity in microsiemens
Low water pressure alarm 5 psi (35 kPa)
Rejection of dissolved salts 90-98%
Rejection of organism (mol wt. greater
than 300), bacteria, pyrogens
Greater than 99%
Output pure water pressure 21 psi (145 kPa)
Disinfectant 37% aqueous formaldehyde or Hydrogen
Peroxide / Peroxyacetic Acid disinfectant
depending on model.

9
STARTUP
Water Supply
Every water supply is different and should be tested to determine the water treatment
required. Always have your water supply tested before connecting the ExtraPure RO
System. In some areas, water softening or other pre-treatment may be required.
Water Supply Requirements
Water supply: 7.5 liters per minute (2.2 gallons per minute) minimum
Pressure between 20 and 100 psi
Water temperature between 5ºC and 35ºC (41ºF and 95ºF)
Water pH between 3.0 and 10.0
Drain capability of 3 liters per minute (0.78 gallons per minute)
Negative test for scaling (Langlier saturation index)
Unpacking
After inspecting the shipping container for damage, open the box, remove all packing
materials, and inspect for damage. Report all damage promptly to the shipping
company and make a claim for compensation. Damage caused in shipment is not
covered by the equipment warranty. Save the shipping carton and packing material for
inspection and verification of your claim.
Inspect the ExtraPure RO System for leaks after unpacking. The ExtraPure RO System
is shipped with a new membrane, an input hose, a drain hose, a sanitize hose and a
new water filter.
The ExtraPure RO System must be disinfected prior to use. Follow procedures on page
16 and page 17 or according to your clinic’s recommendation.

10
The ExtraPure RO System's hoses are shipped with caps on them.
Remove these caps before connecting the hoses.
1. Connect the input hose to the water supply. The
connection is a 3/4" female garden hose connection.
Use rubber washers on all connections.
2. Place the drain hose in the drain.
3. Connect the sanitize hose to the ExtraPure RO System
product water fitting (3/4" male garden hose) and place
the open end in the drain.
4. Check for proper voltage and then plug in the unit.
Installing

11
1. Turn on the water supply. Check for
leaks. You should not hear water
running through the unit until it is
turned on.
2. Lift the rinse lever and turn on the
ExtraPure RO System with the
ON/OFF switch on the control panel.
Look for water flowing through the
drain line and sanitize hose.
3. Run the ExtraPure RO System for 15
minutes to rinse the fluid path.
After 15 minutes, turn off the unit to
install the filter in its blue housing.
Unscrew the housing counter-
clockwise and carefully remove it.
There will be water in the housing.
Empty the housing completely and
refill partially with fresh water. Then
slide the new filter into place and
reinstall the housing. The fresh water
in the housing prevents excessive air
in the fluid path.
After startup, never operate the
ExtraPure RO System without the
filter. Do not use any filter other than
the specified Baxter 5-micron carbon
filter (P/N 407-8502-014 or 5M1315).
RINSE! 4. Rinse the ExtraPure RO System by
lifting the rinse lever on the control
panel and letting the unit run for 15
minutes.
Initial Rinse

12
5. Lower the rinse lever. After a few
minutes, water quality should be
normal and the water quality meter on
the control panel should read in the
green zone (above 90% rejection).
Product ____________
% Rejection _________
Recirculation ________
6. Use the three-position selector switch
on the control panel to determine the
values of the product and the
recirculation water. Write these down
for future reference. If the needle goes
off the right side of the scale, refer to
the Troubleshooting section of this
manual.

13
Normal Operation
1. Rinse and then test for residual disinfectant according to your clinic's
recommendation before connecting the ExtraPure RO System to the dialysis
machine.
2. Turn on the water and turn on the ExtraPure RO System.
3. Note the filter pressure readings at the beginning of use. The difference between
filter/inlet pressure and filter/outlet pressure should always be less than 10 psi with
no water pressure alarm.
CAUTION:
The filter should be changed whenever the product water is below AMMI
Standards, the filter inlet/outlet pressure difference is greater than 10 psi, after 65
hours of operation, or as recommended by your clinic.

14
Cleaning the Membrane
Note: This is not a sanitizing procedure. Follow procedures on page 16 or 17 to
sanitize the system.
1. Disconnect the product water line from the RO and install the sanitize hose. Place
the open end of this hose in the drain.
2. Inject 200-300 ml of white vinegar into the sanitization port. Turn the RO on, let the
machine run for 1 minute, then turn the machine off and let it stand overnight.
3. After allowing the vinegar to dwell overnight, turn the RO on and lift the rinse lever to
the rinse position. Rinse the machine for 15 minutes.
4. Check pH to verify all the vinegar has been flushed out of the RO. If pH is not in the
acceptable range continue the rinse until the pH is within limits.
5. Lower the rinse lever to the operating position and check the water quality meter to
ensure the needle is in the green zone. (If not the membrane will need to be
replaced.)
6. Turn the RO off.
7. Disconnect the sanitize hose from the RO and reconnect the product water line to
the RO.
8. Place the rinse lever in the run position.
The RO is now ready to be put back in service or to Sanitize as outlined on page 16 thru
19.
Filter Replacement
The ExtraPure RO System uses a disposable cartridge filter as illustrated in Figure 4.
The filter should be replaced if the product water is below AMMI Standards, if the
inlet/outlet pressure difference is more than 10 psi, or if the filter has been used more
than 65 hours (13 dialysis treatments).
1. Turn off the water to the unit.
2. Unplug the ExtraPure RO System.
3. To relieve the water pressure inside the unit, disconnect the water line to the dialysis
machine and place it in a clean bucket to avoid contamination.
4. Unscrew the blue filter housing (rear compartment of unit) by turning it
counterclockwise. The housing will have water in it. Pour off the water and set the
housing aside.
5. Remove and discard the old filter.
6. Replace with a new Baxter 5-micron carbon filter (P/N 407-8502-014 or 5M1315).
DO NOT USE ANY FILTER OTHER THAN THE FILTER SPECIFIED. Partially fill
the housing with fresh water to prevent excessive air in the fluid path. Then slide the
filter into place and carefully reinstall the housing.
7. Turn on the water supply and plug in the ExtraPure RO System. Run the unit for 15
minutes with the rinse lever on the control panel in the rinse position. After rinsing,
return the rinse lever to the normal operating position.

15
Figure 4: Filter assembly

16
SANITIZATION
Sanitizing a Formaldehyde RO and Storage Procedure
WARNING: Store all Disinfectants out of reach of children
1. The ExtraPure RO System should be sanitized at least once a week with regular
use, or follow your clinic's recommendation, to prevent bacteria building up in the
water path. Use only 37% aqueous formaldehyde solution (Formalin™).
2. With the unit off, disconnect the water line connecting the ExtraPure RO System to
the dialysis machine. In its place, connect the sanitize hose. Place the end of the
sanitize hose in the drain. Ensure the drain hose is in the drain.
3. Carefully inject 100 cc Formalin™ into the disinfectant port. Slowly inject the
Formalin™ into the disinfectant port on the control panel. Then inject 50 cc water
and reinstall the sanitize cap.
4. Turn on the unit and let it run for 30 - 45 seconds with the rinse lever in the operating
position. (If storage time will be more than three days, remove filter and housing,
and allow to air-dry.
5. Turn off the ExtraPure RO System and turn off the feed water. Let the RO unit stand
with the Formalin™ disinfectant in it until rinsing, according to your dialysis regimen
and your clinic's recommendation. (If storage time will be more than three days,
remove filter and housing, and allow to air-dry.)
6. Rinse the Formalin™ solution from the RO for at least 15 minutes with the rinse
lever in the up position. Rinse until output water tests negative for Formalin™
residuals according to your clinic's procedures. See page 19.
7. Turn off the ExtraPure and the feed water. Disconnect the sanitize hose and
reconnect the product water line to the dialysis machine.
NOTE
In a 7-day period, a typical dialysis regimen will have one
interval between treatments longer than the other interval(s).
For convenience, this longer interval can incorporate the
sanitization of the ExtraPure RO System. For example, in
the dialysis schedule shown, with treatments on Monday,
Wednesday, and Friday, sanitize the ExtraPure RO System
after dialysis on Friday and rinse the unit before dialysis on
Monday.
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