GE MILLENIUM OSMONICS MILLENIUMTM REVERSE OSMOSIS... User manual

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
4-3
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
4-6
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
CHAPTER ONE:
GENERAL INFORMATION

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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.

M 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.