Baxter ExtraPure Manuale utente

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 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.

Figure 1: ExtraPure RO System overview

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

Figure 2: Rear view of RO unit

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.

Figure 3: RO Flow Diagram

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