GE Osmonics F-801 Bedienungsanleitung

GE OSMONICS

F-801 INTERNAL REVERSE OSMOSIS UNIT

Operation

and Maintenance Manual

Revision E

This Revision Supersedes P/n 12552 Rev. D

12552e A

A27 February 2004

F-801 INTERNAL 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

Specifications

Inlet Water Requirements

Flow Rates

Electrical Requirements

Membrane Performance Characteristics

Environmental Requirements

1-12

1.11 Disposal 1-13

1.12 Electromagnetic Interference 1-13

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 2-5

CHAPTER THREE: SYSTEM OPERATION 3-1

Section 3.1 Daily Start-up Procedure 3-3

3.2 Bicarbonate Container Filling 3-6

3.3 Shut Down Procedure 3-6

12552e B

B27 February 2004

CHAPTER FOUR: ROUTINE MAINTENANCE 4-1

Section 4.1

4.1.1

Routine Maintenance of F-801 Internal RO

System

Daily / Per Treatment Maintenance

4-3

4.1.2 Weekly Maintenance 4-5

4.1.3 Monthly Maintenance 4-5

4.1.4 Quarterly Maintenance 4-6

4.1.5 Annual Maintenance 4-6

4.2

4.2.1

Specific Maintenance Procedures and Instructions

Motor Lubricant Procedure

4-7

4.2.2 Leak Repair 4-7

4.2.3 Pre-filter Replacement 4-9

4.3 F-801 Cleaning Indications 4-11

4.3.1 Pre-Cleaning Preparation 4-12

4.3.1.1 Pre-Cleaning Procedure 4-12

4.3.1.2 Cleaner Recirculation and Dwell Time 4-13

4.3.1.3 Post-Cleaning Rinse Procedure 4-14

4.3.2 BIOSAN Pre Cleaning Preparation 4-16

4.3.2.1 BIOSAN Cleaning Procedure 4-16

4.3.2.2 BIOSAN Recirculation and Dwell Time 4-17

4.3.2.3 BIOSAN Post Cleaning Rinse Procedure 4-18

4.4 F-801 Disinfection Indications 4-20

4.4.1 Formaldehyde Disinfection Preparation 4-20

4.4.1.1 Formaldehyde Pre-Disinfection Procedure 4-21

4.4.1.2 Formaldehyde Disinfection and Dwell Time 4-22

4.4.1.3 Formaldehyde Post-Disinfection Rinse Procedure 4-23

4.4.2 “RENALIN®” Disinfection Procedure

(Peracetic Acid and Peroxide-Based Compounds

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

4-24

4.4.2.1 “RENALIN®” Pre-Disinfection Preparation 4-25

4.4.2.2 “RENALIN®” Disinfection and Dwell Time 4-26

4.4.2.3 “RENALIN®” Post-Disinfection Rinse Procedure 4-28

4.5 Product Water Culture 4-29

4.5.1 Product Water Culture Procedure 4-30

4.6 System Storage 4-31

4.6.1 Formaldehyde Storage Procedure 4-31

4.6.2 BIOSAN Storage Procedure 4-32

12552e C

C27 February 2004

CHAPTER FIVE: TROUBLESHOOTING 5-1

Table of Content 5-3

Section 5.1 RO Fails to Run 5-5

5.2 RO Runs Intermittently 5-5

5.3 Motor Runs Hot 5-6

5.4 Low Pump Pressure 5-6

5.5 Pressure Gauge Vibrates Erratically 5-7

5.6 Excess Product Pressure (too high) 5-7

5.7 Product Flow Too Low 5-7

5.8 Product Flow Too High 5-8

5.9 Membrane Product Pressure Too Low 5-9

5.10 Leaks 5-9

5.11 Low Percent Rejection 5-9

5.12 Rejection Display Fluctuates 5-10

5.13 TDS Value High 5-10

5.14 RO Fails to Draw Disinfectant 5-11

5.15 RO Pump Leaks 5-12

CHAPTER SIX: DRAWINGS 6-1

CHAPTER SEVEN: SPARE PARTS LIST 7-1

12552e D

D27 February 2004

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F-801 Internal RO System by GE Osmonics

12552e – 27 Feb 04 1 - 1 General Information

F-801 Internal RO System

CHAPTER ONE:

GENERAL INFORMATION

F-801 Internal RO System by GE Osmonics

12552e – 27 Feb 04 1 - 2 General Information

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F-801 Internal RO System by GE Osmonics

12552e – 27 Feb 04 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 F-801 Internal 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.

F-801 Internal RO System by GE Osmonics

12552e – 27 Feb 04 1 - 4 General Information

USE PROPER WATER AND DRAIN CONNECTIONS:

Use proper water and drain connections to prevent contamination of the RO and danger

to the patient. To ease confusion, the Quick Disconnect (QD) fittings have been color-

coded. Both the male and female fittings are colored. The color coding is; Green =

FEED water, Red = WASTE water, White = PERMEATE (Product) water.

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 liquids. Fix any leaks from the hemodialysis

unit promptly.

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.

DO NOT TRY TO CATCH THE EQUIPMENT IF IT STARTS TO FALL OVER:

The overall assembly is weighty and can cause physical harm.

1.3 Applications

The F-801 Internal 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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