Mar Cor Purification MILLENIUM HX User manual

3030226 Rev. D ?
Mar Cor Purification
MILLENIUM HX®REVERSE OSMOSIS UNIT
Operation and Maintenance Manual

Trademarks
MILLENIUM HX®is a registered trademark of Mar Cor Purification
MINNCARE®HD is a registered trademark of Medivators Inc.
Viton®is a registered trademark of E.I. Du Pont De Nemours And Company
Liqui-Clean™and Biosan™ are registered trademarks of GE Osmonics, Inc.
Memstor™is a trademark of King Lee Technologies

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3030226 Rev. D A ?
TABLE OF CONTENTS
CHAPTER 1: GENERAL INFORMATION....................................................................1-1
1.1 The Manual ................................................................................................1-3
1.2 General Notes, Cautions and Warnings ........................................................1-3
1.3 Applications ...............................................................................................1-7
1.4 Intended Use..............................................................................................1-7
1.5 Contraindications .......................................................................................1-7
1.6 Environmental Considerations.....................................................................1-8
1.6.1 Power............................................................................................................1-8
1.6.2 Water ............................................................................................................1-8
1.6.3 Drain .............................................................................................................1-8
1.6.4 Water Purity...................................................................................................1-9
1.6.5 Temperature ..................................................................................................1-9
CHAPTER 2: INSTALLATION AND INITIAL SYSTEM START-UP ...................................2-1
2.1 Installation Considerations..........................................................................2-3
2.2 Installation Procedures ...............................................................................2-3
2.3 Product Water AAMI Analysis Procedure ...................................................2-13
CHAPTER 3: SYSTEM OPERATION ..........................................................................3-1
3.1 Daily Start-Up.............................................................................................3-3
3.2 Shut-Down Procedure.................................................................................3-6
3.3 Disinfection Indications...............................................................................3-7
3.3.1 Heat Disinfection Procedure (Single Heat) .........................................................3-8
3.4 System Storage.........................................................................................3-11
3.4.1 Storage Heat Procedure.................................................................................3-12
CHAPTER 4: SCREEN OPERATION AND SPECIFICATIONS ..........................................4-1
4.1 Theory of Operation ...................................................................................4-3

3030226 Rev. D B ?
4.2 Fluid Components.......................................................................................4-3
4.2.1 Solenoid Valves...............................................................................................4-4
4.2.2 Check Valves ..................................................................................................4-4
4.2.3 High-Pressure Pump (HPP) ...............................................................................4-5
4.2.4 Level Switches (L1, L2 and L3)...........................................................................4-5
4.2.5 RO Membrane Assembly (ROMA) .....................................................................4-5
4.2.6 Feed Port .......................................................................................................4-5
4.2.7 Product Port...................................................................................................4-5
4.2.8 Waste Port .....................................................................................................4-5
4.2.9 Product Return Port ........................................................................................4-5
4.2.10 RO Feed Water Conductivity Sensor (WP1) ......................................................4-6
4.2.11 Product Water Conductivity Sensor (WP2).......................................................4-6
4.2.12 RO Feed Water Pressure Sensor (PT1) .............................................................4-6
4.2.13 Pump Outlet Pressure Sensor (PT2).................................................................4-6
4.2.14 Product Water Pressure Sensor (PT3) ..............................................................4-6
4.2.15 Pressure Regulator (PR) .................................................................................4-6
4.3 System Operation Controls..........................................................................4-7
4.4 Alarm Screens ..........................................................................................4-20
4.5 Optional Equipment..................................................................................4-22
4.5.1 Pretreatment Cart.........................................................................................4-22
4.5.2 Carbon Filter Tanks .......................................................................................4-22
4.5.3 Carbon Block ................................................................................................4-22
4.5.4 Softeners .....................................................................................................4-23
4.5.5 Dealkalizers..................................................................................................4-23
4.6 Specifications ...........................................................................................4-24
4.6.1 RO Feed Water Requirements ........................................................................4-24
4.6.2 Flow Rates ...................................................................................................4-25
4.6.3 Electrical Requirements .................................................................................4-25
4.6.4 Dimensions ..................................................................................................4-25
4.6.5 Membrane Performance Characteristics..........................................................4-25
4.6.6 Environmental Requirement ..........................................................................4-26
4.6.7 Approvals.....................................................................................................4-26
4.7 Disposal ...................................................................................................4-26
4.8 Electromagnetic Interference ....................................................................4-27
4.9 Service Assistance.....................................................................................4-31
4.10 Return Materials Authorization (RMA) Procedure.....................................4-31
4.11 Symbols and Abbreviations .....................................................................4-32

3030226 Rev. D C ?
CHAPTER 5: ROUTINE MAINTENANCE ...................................................................5-1
5.1 Routine Maintenance..................................................................................5-3
5.1.1 Per Treatment Day Maintenance ......................................................................5-4
5.1.2 Weekly Maintenance.......................................................................................5-4
5.1.3 Monthly Maintenance .....................................................................................5-5
5.1.4 Quarterly Maintenance ...................................................................................5-5
5.1.5 Annual Maintenance .......................................................................................5-6
5.1.6 As Required....................................................................................................5-6
5.2 Specific Maintenance Procedures and Instructions .......................................5-7
5.2.1 Leak Repair ....................................................................................................5-7
5.2.2 Conductivity/Temperature Sensor Verification...................................................5-9
5.2.3 Membrane Replacement ...............................................................................5-10
5.3 Cleaning Indications..................................................................................5-12
5.3.1 Cleaning Procedure .......................................................................................5-13
5.4 Chemical Sanitization Procedure................................................................5-19
5.5 Product Water Microbiological Testing ......................................................5-25
5.5.1 Product Water Culture Procedure...................................................................5-25
5.5.2 Endotoxin Testing Procedure..........................................................................5-27
5.6 Chemical Storage Procedure......................................................................5-28
5.7 Auto Run..................................................................................................5-30
CHAPTER 6: TROUBLESHOOTING...........................................................................6-1
6.1 RO Fails to Run ...........................................................................................6-3
6.2 RO Feed Pressure Alarm..............................................................................6-3
6.3 Product Water Quality Alarm ......................................................................6-4
6.4 This Unit Must Stand Upright Alarm.............................................................6-4
6.5 Product Water High Temperature ................................................................6-5
6.6 RO Feed Water Quality Alarm......................................................................6-5
6.7 Pump Pressure Alarm..................................................................................6-6
6.8 Product Pressure High Alarm .......................................................................6-6
6.9 Service Required Component Failure Detected .............................................6-7
6.10 Product Flow Too Low...............................................................................6-8
6.11 Product Flow Too High ..............................................................................6-9
6.12 Leaks........................................................................................................6-9

3030226 Rev. D D ?
6.13 Low Percent Rejection.............................................................................6-10
6.14 TDS/µS Value High ..................................................................................6-11
CHAPTER 7: DRAWINGS........................................................................................7-1
7.1 Component Identification ...........................................................................7-3
7.1.1 Front View .....................................................................................................7-3
7.1.2 Rear View.......................................................................................................7-4
7.1.3 Electrical Right Side View .................................................................................7-5
7.1.4 Electrical Left Side View...................................................................................7-6
7.1.5 Membrane Assembly.......................................................................................7-7
7.1.6 Top Hydraulic View .........................................................................................7-8
7.1.7 Center Hydraulic View .....................................................................................7-9
7.1.8 Main Manifold..............................................................................................7-10
7.1.9 Lower Hydraulic View....................................................................................7-11
7.1.10 Tank View ..................................................................................................7-12
7.2 Flow Schematics .......................................................................................7-13
7.2.1 Run Mode ....................................................................................................7-13
7.2.2 Divert to Drain..............................................................................................7-14
7.2.3 Heat/Chemical Purge.....................................................................................7-15
7.2.4 Heat/Chemical Recirculation ..........................................................................7-16
7.3 Electrical Diagram.....................................................................................7-17
7.4 Maintenance Schedule..............................................................................7-18
CHAPTER 8: SPARE PARTS.....................................................................................8-1
8.1 Spare Parts List...........................................................................................8-3

Millenium HX RO System
3030226 Rev. D 1-1 General Information
Millenium HX RO System
CHAPTER 1:
GENERAL INFORMATION

Millenium HX RO System
3030226 Rev. D 1-2 General Information
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Millenium HX RO System
3030226 Rev. D 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
Mar Cor Purification Millenium HX 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 General Notes, Cautions and Warnings
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. 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.
WARNING:
Read this manual prior to operating or servicing this device. This manual must be
read and understood and no deviations from the procedures shall be made. 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.

Millenium HX RO System
3030226 Rev. D 1-4 General Information
WARNING:
Only chemicals listed in the manual may be used with the Millenium HX RO. Other
chemicals may not be compatible with the materials of construction. When using
chemical cleaners or sanitizers, ensure the system is properly rinsed prior to use for
dialysis.
WARNING:
The selection of water treatment equipment for dialysis is the responsibility of the
user and the product water should be tested periodically in accordance with AAMI
and CSA standards.
WARNING:
This device will reach temperatures up to 180°F (82°C). Only appropriate heat
resistant materials can be used for fluid pathways that are disinfected with hot
water.
WARNING:
After installation and subsequent use, if any device in the water treatment system is
changed or replaced, the user should conduct appropriate tests to ensure that the
revised system meets the initial design criteria.
WARNING:
The product water quality is proportional to the RO feed water quality. The product
water may not meet quality limits if RO feed water quality deteriorates significantly.
The user is responsible for monitoring the RO feed water quality.
WARNING:
Carbon cannot be regenerated and must be replaced with new beds when
exhausted or contaminated.
WARNING:
A suitable carbon filter should always be present as pretreatment for the RO in
order to prevent chlorine/chloramine damage to the thin film RO membrane and
harm to the patient. Mar Cor Purification strongly recommends the use of two
carbon devices, used in a series configuration.
WARNING:
This RO can only operate in the vertical position. This machine has been equipped
with a sensor that will prevent operation of the unit while lying horizontal. Damage
to equipment may result if operated in the horizontal position.

Millenium HX RO System
3030226 Rev. D 1-5 General Information
WARNING:
Some settings are user adjustable. Entering the SETTINGS screen and/or adjusting
any settings should only be done by properly trained personnel and according to
facility policies and procedures.
WARNING:
Do not attempt to tamper with or perform any unauthorized modifications to the
device including programming changes. Any unauthorized work on the device could
cause damage to the equipment or harm to personnel if any safety features are
circumvented.
WARNING:
While a water treatment system may produce water of sufficient quality to meet
the requirements of AAMI and CSA standards, distribution of the water may
degrade its quality to the point where it no longer meets the requirements of the
above mentioned standards if the distribution system is not maintained
appropriately.
WARNING:
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.
WARNING:
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 free of water.
WARNING:
During operation of the equipment, position the RO so there is access to the power
switch located on the back of the machine.
WARNING:
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.
WARNING:
To avoid fire or explosion, do not operate this device in an explosive environment or
near flammable products.

Millenium HX RO System
3030226 Rev. D 1-6 General Information
WARNING:
Do not remove the back panel of the RO during operation. System is under
pressure during operation. Only remove panel when RO is turned OFF.
WARNING:
To avoid physical and/or equipment harm, move the RO by using both handles at all
times.
CAUTION:
Do not cover or enclose the RO during operation to ensure the unit properly
dissipates heat.
CAUTION:
The input water quality to the RO must meet the National Primary Drinking Water
Standards of the United States Environmental Protection Agency (EPA) or Canadian
Federal and Provincial guidelines governing drinking water in Canada. If the input
water does not meet these standards, the RO may not produce water that meets
AAMI and CSA standards.
NOTE:
Use proper wiring and connection methods to satisfy hospital electrical codes.
NOTE:
Use proper water and drain connections to prevent contamination of the RO and
danger to the patient. The Product/Return Ports are male quick disconnect to
prevent mix up of connection ports.
NOTE:
The Millenium HX RO’s hot water disinfection process is effective in reducing at
least 99.9% of an introduced bacteria load of Pseudomonas aeruginosa under
normal operation conditions.
NOTE:
Clean the HMI display screen as necessary with an alcohol based fluid and a soft
towel as required to maintain the screen’s cleanliness.
NOTE:
This device does not supply hot water to disinfect hemodialysis machines.

Millenium HX RO System
3030226 Rev. D 1-7 General Information
1.3 Applications
The Millenium HX 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 inorganic contaminants and approximately 99%
of all microorganisms, pyrogens, particulates and organics with a molecular weight
greater than 300 removed. The quality of the purified water, referred to as product
water or permeate, depends on the quality of the RO feed water and normally is equal
to or exceeds standards set forth by AAMI and CSA for water treatment equipment
hemodialysis applications. Refer to Technote 103 for AAMI and CSA Product Water
Quality Standards.
1.4 Intended Use
The Mar Cor Purification Millenium HX Portable Reverse Osmosis Water Purification
System is intended to be used as dialysis accessory to produce water through reverse
osmosis for use with hemodialysis equipment.
The Millenium HX can be connected to hemodialysis equipment used in hospitals,
clinics and in home environments, in conjunction with the appropriate pre and post
treatment units, as a part of a water treatment system designed to meet current AAMI
and Federal (US.) Standards.
1.5Contraindications
WARNING:
This system is not designed, sold, or intended for use in producing water for
injection.
Mar Cor Purification systems are not intended to be used outside of the device
specifications and limitations, as outlined in this manual and other related material. If
this equipment is used in a manner not specified by the operating instructions, the
protection provided by the equipment may be impaired.

Millenium HX RO System
3030226 Rev. D 1-8 General Information
1.6 Environmental Considerations
Prior to the installation of the Millenium HX RO, it will be necessary to provide utilities
and create an environment suitable for the trouble free operation of the RO and its
accessories.
WARNING:
Ordinary pipe dope must be avoided since it may leach objectionable and
potentially dangerous impurities into the water.
CAUTION:
It is necessary to keep the RO from freezing to prevent serious damage to the RO.
CAUTION:
The use of mobile telephones or communication equipment in the vicinity of the
Millenium HX could adversely influence the performance of the machine. See
specification in Section 4.8.
CAUTION:
Millenium HX needs special precautions regarding EMC and needs to be installed
and put into service according to the EMC information provided in the Operators
and Service Manuals.
1.6.1 Power
The RO operates on 115/230 VAC single-phase power. Histories of power failure,
power surges, and low line voltages should be noted and reported to the manufacturer
or their agent as they may create adverse conditions for the operation of equipment.
1.6.2 Water
Reverse osmosis systems require a reliable water source (rapid pressure fluctuation of
greater than 10 PSI should be avoided to prevent damage). The RO needs a minimum of
20 PSI pressure at a minimum flow of 1.5 gallons per minute. It is important that water
is flowing at the design flow rate when testing water pressure rather than reading static
pressure. Inlet water must contain less than 0.1 ppm free chlorine.
1.6.3 Drain
A drain outlet is required for the RO. The drain must have a minimum capacity of 2
gallons per RO per minute of continuous flow for as long as and as often as the RO is
operating.

Millenium HX RO System
3030226 Rev. D 1-9 General Information
1.6.4 Water Purity
Plumbing materials can significantly contribute to the contamination of the water.
Metallic pipes (with the exception of 316 stainless steel) must be eliminated once the
purification process has begun. Schedule 40 or 80 PVC pipes, polypropylene, PVDF, and
other FDA recommended materials are suitable for most grades of purified water. Care
must also be exercised in the choice of a thread sealant.
1.6.5 Temperature
The RO is normally connected to a cold water supply. The performance specifications of
the RO are based on 77°F (25°C) RO feed water temperature. The Millenium HX
contains a VFD motor that will increase the pump speed when operating on cold water
helping to increasing the amount of product water produced.

Millenium HX RO System
3030226 Rev. D 1-10 General Information
NOTES:

Millenium HX RO System
3030226 Rev. D 2-1 Installation And
Initial System Start-Up
Millenium HX RO System
CHAPTER 2:
INSTALLATION AND
INITIAL SYSTEM START-UP

Millenium HX RO System
3030226 Rev. D 2-2 Installation And
Initial System Start-Up
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