Baxter ExtraPure RO 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

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 single­patient 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.

1

Figure 1: ExtraPure RO System overview

2

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)

approximate

TDS (ppm)

meter red yellow green

% rejection below 80% 80%-89% 90% and greater

meter 1.5 2 3 4 5 6 7 8 9 10

conductivity

(µS/cm)

approximate

TDS (ppm)

126 49 31 17 12 9 8 6 6 5

85 33 21 12 8 6 5 4 4 3

% REJECTION

RECIRCULATION WATER

1451 871 484 335 256 207 174 150 132 118

980 588 327 226 173 140 117 101 89 79

3

Figure 2: Rear view of RO unit

4

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.

5

Figure 3: RO Flow Diagram

6

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

Filter Contains both a fiber material (5-10 micron) and activated carbon. The

Heat exchanger Tubing around the pump motor to cool the motor and warm the water.

Water pressure
regulator (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
Thermistor Used to monitor the water temperature. This information is used in

Conductivity cells Used to measure the conductance of the recirculating and product

Procon pump Pump used in RO to push the water across the membrane. The pump

RO module Contains the thin film composite (TFC) membrane, which is the heart of

Test points Plugged holes in the system's flow block, which can be used by service

Pressure regulator
(200 psi)
Flow regulator A restrictor used to limit the flow of water to the drain during normal

Fast rinse valve Opened to create a high flow to drain when rinsing disinfectant from the

Check valve
(product line)

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.

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.

This is done so the motor can be enclosed in insulation without

overheating and warmer water assists the membrane in producing

quality water.

Regulates the water pressure to the Procon pump at 20 psi.

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.

conjunction with the two conductivity cells to determine the total ion

concentration of the recirculating and product water.

water. This information is combined to yield the display of percent

rejection on the front panel.

can produce pressures much higher than the 200 psi which is

necessary in the RO.

the system.

personnel to test pressures and set the pressure regulators.

Provides the backpressure necessary for the Procon pump to create

the 200 psi required to push water across the membrane.

function. The drain flow is about 1000mL/min.

system. This reduces the waiting time before the unit can be used.

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.

7

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

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

Rated output at 25ºC (77ºF) input water
temperature

Rated output at 5ºC (41ºF) input water
temperature

Size unit Depth - 406 mm (16")

Weight 27 kg (60 lb)

RO membrane operating pressure 200 psi (1,380 kPa)

Depends on pH of feed water

5ºC to 35ºC (41ºF to 95ºF)

500 - 1,100 mL/min minimum

525 mL/min minimum

Width - 406 mm (16")

Height - 710 mm (28")

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

Output pure water pressure 21 psi (145 kPa)

Disinfectant 37% aqueous formaldehyde or Hydrogen

Greater than 99%

Peroxide / Peroxyacetic Acid
depending on model.

8

disinfectant