GE MILLENIUM OSMONICS MILLENIUMTM REVERSE OSMOSIS... Manuel utilisateur

GE OSMONICS

MILLENIUM™ REVERSE OSMOSIS UNIT

Operation

and Maintenance Manual

SUPERCEDES P/N 14693 REV. D

14693e A

A31 March 2003

MILLENIUM REVERSE OSMOSIS UNIT

Installation, Operation and Maintenance Manual

TABLE OF CONTENTS

Page

CHAPTER ONE: GENERAL INFORMATION 1-1

Section 1.1 The Manual 1-3

1.2 Safety Summary 1-3

1.3 Applications 1-4

1.4 Contraindications 1-4

1.5 Environmental Considerations 1-5

1.6 Theory of Operation 1-6

1.7 Fluid Components 1-7

1.8 Monitors and Controls 1-9

1.9 Optional Equipment 1-11

1.10

1.10.1

1.10.2

1.10.3

1.10.4

1.10.5

1.10.6

Specifications

Inlet Water Requirements

Flow Rates

Electrical Requirements

Dimensions

Membrane Performance Characteristics

Environmental Requirements

1-12

1.11 Disposal 1-13

1.12 Electromagnetic Interference 1-14

1.13 Service Assistance 1-14

1.14 Return Goods Authorization (RGA) 1-15

1.15 Symbols and Abbreviations 1-16

CHAPTER TWO: INSTALLATION GUIDELINES AND INITIAL

SYSTEM START UP

2-1

Section 2.1 Installation Considerations 2-3

2.2 Installation Procedure 2-3

2.3 Product Water Analysis Procedure 2-6

CHAPTER THREE: SYSTEM OPERATION 3-1

Section 3.1 Daily Start-up Procedure 3-3

3.2 Shut Down Procedure 3-3

14693e B

B31 March 2003

CHAPTER FOUR: ROUTINE MAINTENANCE 4-1

Section 4.1

4.1.1

Routine Maintenance of Millenium™ RO System

Daily / Per Treatment Maintenance

4-3

4.1.2 Weekly Maintenance 4-4

4.1.3 Monthly Maintenance 4-4

4.1.4 Quarterly Maintenance 4-4

4.1.5 Semi-Annual Maintenance 4-5

4.1.6 Annual Maintenance 4-5

4.2

4.2.1

Specific Maintenance Procedures and Instructions

Motor Lubricant Procedure

4-6

4.2.2 Leak Repair 4-6

4.2.3 Product Recirculation Check Valve Test 4-9

4.3 Millenium™ Cleaning Indications 4-9

4.3.1 Pre Cleaning Preparation 4-10

4.3.1.1 Pre Cleaning Procedure 4-10

4.3.1.2 Cleaner Recirculation and Dwell Time 4-11

4.3.1.3 Post Cleaning Rinse Procedure 4-12

4.3.2 BIOSAN™ Pre Cleaning Preparation 4-14

4.3.2.1 BIOSAN™ Cleaning Procedure 4-14

4.3.2.2 BIOSAN™Recirculation and Dwell Time 4-15

4.3.2.3 BIOSAN™ Post Cleaning Rinse Procedure 4-16

4.4 Millenium™Disinfection Indications 4-17

4.4.1 Formaldehyde Disinfection Preparation 4-17

4.4.1.1 Formaldehyde Pre Disinfection Procedure 4-18

4.4.1.2 Formaldehyde Disinfection and Dwell Time 4-18

4.4.1.3 Formaldehyde Post Disinfection Rinse Procedure 4-19

4.4.2 “RENALIN®” Disinfection Procedure

(Peracetic Acid and Peroxide-Based Compounds

such as Renalin®, Minncare™, & Peracidin™)

4-21

4.4.2.1 “RENALIN®” Pre Disinfection Preparation 4-22

4.4.2.2 “RENALIN®” Disinfection and Dwell Time 4-23

4.4.2.3 “RENALIN®” Post Disinfection Rinse Procedure 4-23

4.5 Product Water Culture 4-25

4.5.1 Product Water Culture Procedure 4-26

4.6 System Storage 4-27

4.6.1 Formaldehyde Storage Procedure 4-27

4.6.2 BIOSAN™ Storage Procedure 4-28

14693e C

C31 March 2003

CHAPTER FIVE: TROUBLESHOOTING 5-1

Table of Content 5-3

Section 5.1 Unit Fails to Run 5-5

5.2 Unit Runs Intermittently 5-5

5.3 Motor Runs Hot 5-6

5.4 Water Produced While Unit is Off 5-6

5.5 Low Pump Pressure 5-7

5.6 Pressure Gauge Vibrates Erratically 5-7

5.7 Excess Product Pressure (too high) 5-7

5.8 Product Flow Too Low 5-8

5.9 Product Flow Too High 5-8

5.10 Leaks 5-9

5.11 Low Percent Rejection 5-9

5.12 TDS Value High 5-10

5.13 RO Fails to Draw Disinfectant 5-11

5.14 RO Pump Leaks 5-11

5.15 TDS Value Fluctuates 5-11

CHAPTER SIX: DRAWINGS 6-1

CHAPTER SEVEN: SPARE PARTS LIST 7-1

14693e D

D31 March 2003

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Millenium™ RO System by GE Osmonics

14693e – 31 Mar 03 1 - 1 General Information

Millenium RO System

CHAPTER ONE:

GENERAL INFORMATION

Millenium™ RO System by GE Osmonics

14693e – 31 Mar 03 1 - 2 General Information

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Millenium™ RO System by GE Osmonics

14693e – 31 Mar 03 1 - 3 General Information

1.1 The Manual

This manual has been prepared to provide the operator with information and instructions

regarding the installation, use, maintenance and troubleshooting of the GE Osmonics

Millenium™ Reverse Osmosis System.

CAUTION:

When used as a medical device, Federal law restricts this device to sale by or on the

order of a physician. Per CFR 801.109 (b)(1).

The manual has been written in narrative form supplemented with schematics and

drawings for clarification. The operator can perform most procedures mentioned in this

manual. Any exceptions will be clearly identified by a qualifying statement.

1.2 Safety Summary

Words in BOLD CAPITAL letters are used to identify labels on the device and key

safety or qualifying statements. A list of all symbols and abbreviations is located at the

end of this chapter. See Technote 120 for a glossary of relevant terms.

This safety summary does not contain all of the safety statements in the manual. Other

safety statements are included within the manual text and are enhanced and defined as

follows:

NOTE:

Statements that provide further clarification.

CAUTION:

Statements identifying conditions or practices that could result in equipment or

other property damage.

WARNING:

Statements identifying conditions or practices that could result in personal injury or

loss of life.

READ THIS MANUAL:

Prior to operating or servicing this device, this manual must be read and understood.

Keep this and other associated manuals for future reference and for new operators or

qualified service personnel. A note sheet is provided at the end of each chapter for

operators to make notations that may be valuable to other users.

USE PROPER POWER CONNECTIONS:

Use proper wiring and connection methods to satisfy hospital electrical codes.

DO NOT REMOVE COVERS OR PANELS:

To avoid electrical shock hazard, do not remove covers or panels when power is supplied

to the device. Do not operate the device when covers or panels are removed.

Millenium™ RO System by GE Osmonics

14693e – 31 Mar 03 1 - 4 General Information

SHOCK HAZARD:

Connect this device to a proper ground connection in accordance with the National

Electrical Code. DO NOT under any circumstances remove the ground wire or ground

prong from any power plug. DO NOT use an extension cord with this equipment. Keep

the surface under the RO(s) free of water.

DEVICE LABELING:

Do not under any circumstances; remove any Caution, Warning or any other descriptive

labels from the devices until the conditions warranting the label are eliminated.

DO NOT OPERATE IN A FLAMMABLE ATMOSPHERE:

To avoid fire or explosion, do not operate this device in an explosive environment or near

flammable anesthetics.

1.3 Applications

The Millenium™ Reverse Osmosis (RO) System is designed to purify water by forcing

water through a semi-permeable RO membrane. Water purified by reverse osmosis has

had approximately 95% of the dissolved ions and approximately 99% of most other

contaminants removed. The quality of the purified water, referred to as product water or

permeate, depends on the quality of the feed water and normally is equal to or exceeds

AAMI standards. Such water is suitable for hemodialysis applications.

1.4 Contraindications

WARNING:

GE Osmonics systems are not designed, sold, or intended for use in producing

water for injection

Furthermore, GE Osmonics systems are not intended to be used outside of the device

specifications and limitations, as outlined in this manual and other related materials.

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