RR Mechatronics RPI Manuale utente

Instructions for Use

RPI

MRN-184-EN Version 6 (05-01-2022)

Contents

- Document history overview. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7

1 - Introduction. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8

1.1 - - About this manual. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8

1.2 - - Used symbols. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8

1.3 - - Installation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9

1.4 - - Disclaimer. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10

2 - Intended use RPI. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11

3 - Installation procedures and requirements. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12

3.1 - - Feed water requirements. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12

4 - Principles of operation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13

5 - Performance characteristics and specifications. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14

5.1 - - Technical specifications. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15

5.2 - - User level description. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20

5.3 - - Application. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21

5.4 - - Output performance characteristics. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21

5.5 - - Waste. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21

5.6 - - Identification and Labelling. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22

6 - Standard operation procedures. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23

6.1 - - Check before starting up after inactive period. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23

6.2 - - Normal operation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23

6.3 - - Cubitainer Status. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25

6.4 - - Replacement of the cubitainers and RPI-Check bottle. . . . . . . . . . . . . . . . . . . . . . . . . . . 26

6.4.1 - - Placement of a new cubitainer. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28

6.4.2 - - Concentrated reagent lot switch. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34

6.4.3 - - Placement of a new RPI-Check bottle. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35

6.5 - - Checks during operation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37

7 - Calibration procedures. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38

7.1 - - Control cycle. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38

8 - User interface and software menu. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40

Contents

MRN-184-EN Version 6 (05-01-2022) 3

8.1 - - User Menu. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41

8.2 - - Access levels. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42

8.3 - - Operator level. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43

8.4 - - Supervisor level. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45

8.5 - - Technician level. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 48

8.6 - - Home screen. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 48

8.7 - - Manual screen. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 51

8.7.1 - - Manual Control cycle. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 52

8.7.2 - - Replace cubitainer function and adding users. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 52

8.7.3 - - Manual insert cubitainer ID. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 54

8.7.4 - - Manual insert RPI-Check ID. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 56

8.8 - - Information screen. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 58

8.8.1 - - Retrieve performance data. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 59

8.8.2 - - Instrument state. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 61

8.8.3 - - Instrument information. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 61

8.9 - - Maintenance screen. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 62

8.9.1 - - WPU maintenance. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 62

8.9.2 - - RPI maintenance. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 63

8.10 - - Settings. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 64

9 - Operational precautions, limitations and hazards. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 66

9.1 - - Avoidance of infection. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 67

10 - Troubleshooting. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 68

10.1 - - No water. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 69

10.2 - - Concentrated reagent information is not recognized. . . . . . . . . . . . . . . . . . . . . . . . . . . 69

10.3 - - Reagent errors. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 70

10.4 - - Control cycle does not start or fails. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 71

11 - Maintenance. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 72

11.1 - - Maintenance items & Maintenance schedule RPI. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 73

11.2 - - Removing and replacing cover panels. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 74

11.3 - - Replacing the Vent filter. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 75

11.4 - - Replacing peristaltic pump tubes. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 77

11.5 - - Replacing Pickup tubes/End point filters. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 82

11.6 - - Maintenance WPU. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 85

11.7 - - Cleaning. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 86

11.7.1 - - Cleaning of the drawers and casing. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 86

11.8 - - Replacing main fuses. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 87

Contents

4MRN-184-EN Version 6 (05-01-2022)

12 - Error list. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 89

13 - System temporarily out of use. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 94

14 - Decommissioning and disposal. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 95

15 - Glossary of Terms. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 96

- Index. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 97

Contents

MRN-184-EN Version 6 (05-01-2022) 5

Manufacturer: RR Mechatronics Manufacturing B.V.

Phone: +31 229 291 129

Fax: +31 229 241 534

E-mail: [email protected]

Internet: www.rrmechatronics.com

Postal address:

P.O. Box 225

1620 AE Hoorn

The Netherlands

Office address:

De Corantijn 13

1689 AN Zwaag

The Netherlands

Subject to changes without prior notice.

Issued by the Support Department of RR Mechatronics

Contents

6MRN-184-EN Version 6 (05-01-2022)

Document history overview

MRN-184-EN

Issue No Date Revised Section(s) Changes Authorised

6 jan. 2021 Disclaimer

Safety

Modification claim

Exposure limits / USB-port use

HSR

5 dec.2021 Calibration procedures

Decommissioning

Metrology traceability addition

Decommissioning only by FSE remark

HSR

4 nov. 2021 All General update including software

version 2.14 and changes due to

wording intended use of RPI-Check

HSR

3 jun. 2021 All General update and changed chapter

sequence according FDA regulations

HSR

2 jan. 2021 All General update HSR

1 oct. 2020 All General update HSR

Document history overview

MRN-184-EN Version 6 (05-01-2022) 7

Introduction

Read this manual, especially the standard operation procedure and Safety instructions , before using the

instrument.

1.1 - About this manual

This manual describes all necessary procedures and information required for the correct and successful use

of the RPI, covering normal operation, user maintenance and troubleshooting. When instrument is

mentioned, it is used for the complete instrument, the RPI including the AFS-24 unit.

This manual is applicable for the following RPI-models and concentrated reagents:

A0021587 RPI-ECO21 (120V), for DxH Concentrated ECO Diluent C67249 (Beckman-Coulter).

A0021595 RPI-ECO21 (230V), for DxH Concentrated ECO Diluent C67249 (Beckman-Coulter).

This manual does not describe specific service related issues, such as detailed technical information and

repair procedures.

The manual found with your RPI is important for proper usage and maintenance in compliance with the

manufacturer specifications.

Your RPI is delivered with these documents:

An "

Instruction for Use

" which describes all specifications, operations, user functions and user maintenance

of the RPI.

A "

User manual AFS® 8, 16, 24

" which describes all specifications, operations, user functions and user

maintenance of the AFS-24 (WPU).

It may be necessary to reference these documents for maintenance or other procedures with the RPI. It is

recommended to store these documents in such way that they can be quickly located and where they will

not be damaged.

Updates of this manual and RPI software will be published on our website, distributors will be informed

about updates. Electronic versions of this manual and versions in available languages and future revisions

are available on:

https://support.rrmechatronics.com

1.2 - Used symbols

This ATTENTION symbol is used to refer to instructions in this manual that need to

be done carefully.

Introduction

8MRN-184-EN Version 6 (05-01-2022)

These symbols are used to indicate that proper safety equipment has to be used.

Protective glasses and gloves must be worn

This UV RADIATION sticker is used to refer to a position on or inside the water

system cabinet where exposure to UV light is possible

This ELECTRICAL GROUND sticker is used to refer to a position on the water system

Cabinet or inside where an electrical ground connection is made.

This DANGER sticker is used to refer to a position on the water system Cabinet or

inside of it that could be hazardous.

This symbol indicates useful information, not related to any specific danger.

1.3 - Installation

The instrument must be installed in a dry and dust-free location on a solid and stable surface.

Do not expose the instrument to excessive temperature fluctuation and direct sunlight.

Avoid shocks and vibrations. Ensure good ventilation and do not place the instrument directly in contact with

other equipment.

Leave >1m space in front of the instrument to be able to move the instrument forwards to perform

maintenance activities at the back side.

Avoid installation near devices causing interference e.g. radios, centrifuges, etc. Installation of the

instrument in places where chemicals are stored or gas develops is not permitted.

Introduction

MRN-184-EN Version 6 (05-01-2022) 9

1.4 - Disclaimer

Operate and maintain this instrument according to this manual and other instructions from the manufacturer.

Failures and defects as result of unspecified use will void the product warranty. Changes or modifications not

expressly approved by the party responsible for compliance could void the user’s authority to operate the

equipment.

The instrument is not equipped with backup- or control systems to prevent production of incorrect reagent

due to conditions such as:

▪ Uncalibrated measuring circuitry

▪ Instrument malfunction

▪ Poor quality of concentrated reagent

▪ Poor quality of feed water

The RPI (including WPU) is designed to stay connected to the main power supply and water

supply at all times.

The quality of RPI’s production has to be checked daily for use on the connected analyzers

according local quality specifications.

Do not disconnect the RPI(s) prior to completion of the shut-down cycle.

The manufacturer disclaims any liability for any direct, indirect, incidental, special or

consequential damages of any kind, arising from the use of incorrect prepared reagent.

Note:

This equipment has been tested and found to comply with the limits for a Class A digital device,

pursuant to part 15 of the FCC Rules. These limits are designed to provide reasonable protection

against harmful interference when the equipment is operated in a commercial environment. This

equipment generates, uses, and can radiate radio frequency energy and, if not installed and used in

accordance with the instruction manual, may cause harmful interference to radio communications.

Operation of this equipment in a residential area is likely to cause harmful interference in which case

the user will be required to correct the interference at his own expense.

Introduction

10 MRN-184-EN Version 6 (05-01-2022)

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