Roche Elecsys1010 Service manual

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Elecsys 1010 Service Manual

Service ManualService Manual

Service Manual

Service ManualService Manual

Elecsys 1010Elecsys 1010

Elecsys 1010

Elecsys 1010Elecsys 1010

FINAL 2.1 - February 2000

Page 2

Elecsys 1010 Service Manual

This manual is published by Roche Diagnostics GmbH,

Technical Product Management and Service Department.

No part of this publication may be reproduced without the expressed written permission of Roche Diagnostics GmbH.

Disclaimer

Roche Diagnostics GmbH makes no representation or warranties with respect to the contents of this documentation and specifically disclaims any implied warranties, including the implied warranties of merchantability and fitness for a particular purpose.

In no case shall Roche Diagnostics GmbH be liable for incidental or consequential damages.

FINAL 2.1 - February 2000

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Elecsys 1010 Service Manual

How to Use this ManualHow to Use this Manual

How to Use this Manual

How to Use this ManualHow to Use this Manual

It may occur that identical components occur several times in Elecsys 1010 and perform different functions. Every component has an ID number in the figures.

Photo Coupler Assy, preadjusted (416)Photo Coupler Assy, preadjusted (416)

Photo Coupler Assy, preadjusted (416)

e.g.

Photo Coupler Assy, preadjusted (416)Photo Coupler Assy, preadjusted (416) Photo Coupler Assy, preadjusted (418)Photo Coupler Assy, preadjusted (418)

Photo Coupler Assy, preadjusted (418)

Photo Coupler Assy, preadjusted (418)Photo Coupler Assy, preadjusted (418)

416

418

D-10

In Chapter 5 Electronics the components are referred to as functional units.

Photo Coupler Magnet Home (418)Photo Coupler Magnet Home (418)

Photo Coupler Magnet Home (418)

e.g .

Photo Coupler Magnet Home (418)Photo Coupler Magnet Home (418) Photo Coupler Magnet Cell (416)Photo Coupler Magnet Cell (416)

Photo Coupler Magnet Cell (416)

Photo Coupler Magnet Cell (416)Photo Coupler Magnet Cell (416)

FINAL 2.1 - February 2000

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Elecsys 1010 Service Manual

In Chapter 4 Mechanics the part name is used. In addition, the information is contained whether the part can be ordered as a spare part ,or if it consists of several components.

Photo Coupler Assy, preadjusted (418)Photo Coupler Assy, preadjusted (418)

Photo Coupler Assy, preadjusted (418)

e.g.

Photo Coupler Assy, preadjusted (418)Photo Coupler Assy, preadjusted (418)

Replaceable Components:

- Peltier Assy Preheater (302)

- Preheater Sipper (306)

- PCB Preamp High Voltage (310)

- Holder Photo Coupler MD1 (326) consisting of:

- Photo Coupler Holder (419)

- Photo Coupler Holder (327)

Photo Coupler Assy, preadjusted (418)Photo Coupler Assy, preadjusted (418)

Photo Coupler Assy, preadjusted (418)

Photo Coupler Assy, preadjusted (418)Photo Coupler Assy, preadjusted (418)

In Chapter 8.2 Part Identification shows where this part is used in Chapter 4 or 5.

Photo Coupler Assy, preadjusted (416)Photo Coupler Assy, preadjusted (416)

Photo Coupler Assy, preadjusted (416)

e.g.

Photo Coupler Assy, preadjusted (416)Photo Coupler Assy, preadjusted (416) Photo Coupler Assy, preadjusted (418)Photo Coupler Assy, preadjusted (418)

Photo Coupler Assy, preadjusted (418)

Photo Coupler Assy, preadjusted (418)Photo Coupler Assy, preadjusted (418)

NoNo

Part Name EnglishPart Name English

Part Name English

NoNo

Part Name EnglishPart Name English

412 TUBING SIPPER (2) 0,8 Detection Module

416416

Photo Coupler Assy, preadjustedPhoto Coupler Assy, preadjusted

416

Photo Coupler Assy, preadjusted

416416

Photo Coupler Assy, preadjustedPhoto Coupler Assy, preadjusted

417 Eccentric Ring, 2 pcs Detection Module

418418

Photo Coupler Assy, preadjustedPhoto Coupler Assy, preadjusted

418

Photo Coupler Assy, preadjusted

418418

Photo Coupler Assy, preadjustedPhoto Coupler Assy, preadjusted

419 Photo Coupler Holder Detection Module 527 Cable M10 Detection Module

In Chapter 8.3 Spare Parts, components that cannot be ordered individually do not have an ID. The part name is followed by a cross reference to the spare part, in which the component is contained.

Photo Coupler Assy, preadjusted (416)Photo Coupler Assy, preadjusted (416)

Photo Coupler Assy, preadjusted (416)

e.g.

Photo Coupler Assy, preadjusted (416)Photo Coupler Assy, preadjusted (416) Photo Coupler Assy, preadjusted (418)Photo Coupler Assy, preadjusted (418)

Photo Coupler Assy, preadjusted (418)

Photo Coupler Assy, preadjusted (418)Photo Coupler Assy, preadjusted (418)

NoNo

IDID

Part Name EnglishPart Name English

Part Name English

Part Name EnglishPart Name English

ElectronicsElectronics

Electronics

ElectronicsElectronics

BP 1BP 1

BP 1

BP 1BP 1 BP 1BP 1

BP 1

BP 1BP 1

MechanicsMechanics

Mechanics

MechanicsMechanics

Detection ModuleDetection Module

Detection Module

Detection ModuleDetection Module Detection ModuleDetection Module

Detection Module

Detection ModuleDetection Module

Spare PartSpare Part

Spare Part

Spare PartSpare Part

BTOBTO

BTO

BTOBTO

ABCABC

ABC

ABCABC

326 1234567890 HOLDER PHOTO COUPLER MD1 X A

416416

416

416416 418418

418

418418

419 Photo Coupler Holder, Part of 326 327 Photo Coupler Holder, Part of 326

FINAL 2.1 - February 2000

Photo Coupler Assy, preadjusted, Part of 326Photo Coupler Assy, preadjusted, Part of 326

Photo Coupler Assy, preadjusted, Part of 326

Photo Coupler Assy, preadjusted, Part of 326Photo Coupler Assy, preadjusted, Part of 326 Photo Coupler Assy, preadjusted, Part of 326Photo Coupler Assy, preadjusted, Part of 326

Photo Coupler Assy, preadjusted, Part of 326

Photo Coupler Assy, preadjusted, Part of 326Photo Coupler Assy, preadjusted, Part of 326

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Elecsys 1010 Service Manual

Application / IntroductionApplication / Introduction

Application / Introduction

Application / IntroductionApplication / Introduction

InstallationInstallation

Installation

InstallationInstallation

FluidicsFluidics

Fluidics

FluidicsFluidics

MechanicsMechanics

Mechanics

MechanicsMechanics

ElectronicsElectronics

Electronics

ElectronicsElectronics

SoftwareSoftware

Software

SoftwareSoftware

Trouble ShootingTrouble Shooting

Trouble Shooting

Trouble ShootingTrouble Shooting

Spare PartsSpare Parts

Spare Parts

Spare PartsSpare Parts

1010

Host InterfaceHost Interface

Host Interface

Host InterfaceHost Interface MaintenanceMaintenance

Maintenance

MaintenanceMaintenance AppendixAppendix

Appendix

AppendixAppendix

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Elecsys 1010 Service Manual

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Elecsys 1010 Service Manual

Application / IntroductionApplication / Introduction

Application / Introduction

Application / IntroductionApplication / Introduction

1.11.1

1.1

1.11.1

1.21.2

1.2

1.21.2

System DescriptionSystem Description

System Description

System DescriptionSystem Description

1.1.11.1.1

1.1.1

1.1.11.1.1

1.1.21.1.2

1.1.2

1.1.21.1.2

1.1.31.1.3

1.1.3

1.1.31.1.3

System SpecificationSystem Specification

System Specification

System SpecificationSystem Specification

.3.3

Operator Precautions andOperator Precautions and

Operator Precautions and

.3.3

Operator Precautions andOperator Precautions and HazardsHazards

Hazards

HazardsHazards

1.3.11.3.1

1.3.1

1.3.11.3.1

Instrument IntroductionInstrument Introduction

Instrument Introduction

Instrument IntroductionInstrument Introduction Principles of the AnalysisPrinciples of the Analysis

Principles of the Analysis

Principles of the AnalysisPrinciples of the Analysis Pipetting SchemePipetting Scheme

Pipetting Scheme

Pipetting SchemePipetting Scheme

1.1.3.11.1.3.1

1.1.3.1

1.1.3.11.1.3.1

Contact PersonsContact Persons

Contact Persons

Contact PersonsContact Persons

Timing DiagramTiming Diagram

Timing Diagram

Timing DiagramTiming Diagram

__________________________________________________________________________________________

_____________________________________________

__________________________________________________________________________________________

________________________________________________________________________________

________________________________________

________________________________________________________________________________

______________________________________________________________________________________________

_______________________________________________

______________________________________________________________________________________________

__________________________________________________________________________

_____________________________________

__________________________________________________________________________

____________________________________________________________________________________________

______________________________________________

____________________________________________________________________________________________

____________________________________________________________________________________

__________________________________________

____________________________________________________________________________________

________________________________________________________________________________

________________________________________

________________________________________________________________________________

__________________________________________________________________________________

_________________________________________

__________________________________________________________________________________

1515

1818

2020

11 55

55 66

1.41.4

1.4

1.41.4

1.3.21.3.2

1.3.2

1.3.21.3.2

1.3.31.3.3

1.3.3

1.3.31.3.3

Service ConceptService Concept

Service Concept

Service ConceptService Concept

1.4.11.4.1

1.4.1

1.4.11.4.1

1.4.21.4.2

1.4.2

1.4.21.4.2

Proved SecurityProved Security

Proved Security

Proved SecurityProved Security Precautions and HazardsPrecautions and Hazards

Precautions and Hazards

Precautions and HazardsPrecautions and Hazards

Service LevelService Level

Service Level

Service LevelService Level RA-Procedure (Replacement of defective parts)RA-Procedure (Replacement of defective parts)

RA-Procedure (Replacement of defective parts)

RA-Procedure (Replacement of defective parts)RA-Procedure (Replacement of defective parts)

______________________________________________________________________________________________

_______________________________________________

______________________________________________________________________________________________

______________________________________________________________________________

_______________________________________

______________________________________________________________________________

__________________________________________________________________________________

_________________________________________

__________________________________________________________________________________

__________________________________________________________________________________________________

_________________________________________________

__________________________________________________________________________________________________

________________________________________

____________________

________________________________________

2020

2020 2020

2020

2222

2222 2222

2222

FINAL 2.1 - February 2000 Chapter 1

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Elecsys 1010 Service Manual

FINAL 2.1 - February 2000 Chapter 1

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Elecsys 1010 Service Manual

1.11.1

1.1

1.11.1

1.1.11.1.1

1.1.1

1.1.11.1.1

System DescriptionSystem Description

System Description

System DescriptionSystem Description

Instrument IntroductionInstrument Introduction

Instrument Introduction

Instrument IntroductionInstrument Introduction

F-9F-9

F-9

F-9F-9

The sequence of operation of Elecsys 1010 is as follows:

Pick-up of sample and reagents

Incubation

Pick-up of incubate and addition of wash and buffer solutions

Measurement of luminescence, data evaluation and output

S/R rotor MFA s/r S/R dilutor Clot detection

Incubation rotor Temperature (incubator)

Bottle temperature MFA assy (sipper)

Sipper dilutor

Measuring cell Potentiostat PMT

Temperature

FINAL 2.1 - February 2000

Chapter 1Page 1

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Elecsys 1010 Service Manual

IntroductionIntroduction

Introduction

IntroductionIntroduction

When the instrument cover top is closed, loading of two This System Description explains functions and their interrelationship.

Short Description of the InstrumentShort Description of the Instrument

Short Description of the Instrument

Short Description of the InstrumentShort Description of the Instrument The Elecsys 1010 is a Multi-Batch-Analyzer which analyzes

immunological tests according to the principle of electrochemical luminescence (ECL). This measuring system is also called ORIGEN® technology. The emitted photons are measured with a photomultiplier (photon counts).

STAT (short-turn-around-time) samples is possible outside

of the direct range of action of the MFA arms and rotors. Pull

out the control panel like a drawer, behind which the holder

for the above mentioned STAT samples is located. By

pushing the control panel back in, the STAT samples are

within the direct range of the pipette needle under the closed

instrument cover without mechanically or logically

interrupting an ongoing process.

Elecsys 1010 has two driving blocks for the sample/

reagent rotor and the incubation rotor. Elecsys 1010 has all the modules and components

necessary for executing the entire analysis including the measurements and evaluation. When operating the instrument (e.g. for test selection and sample placement), the user is guided by menus on the keyboard. Softkeys and function keys can be used for interacting with the instrument. Samples (both in primary tubes and in secondary cups), reagents and calibrators are to be positioned on the sample/ reagent (s/r) rotor. A special reagent bottle combination (RackPack) contains the reagents needed for a test. Each RackPack has a 2-dimensional bar code with all data specific of the test. Positive user identification (PSID) is possible with samples in primary tubes. With samples in secondary cups, patients are identified manually by using the keyboard. After reading the bar code, the RUN is started and performed automatically.

CalibrationCalibration

Calibration

CalibrationCalibration

At the beginning of a RUN a calibration can be performed. The system imposes a full calibration

- if a new reagent (with a new batch number) is put in.

- at regular time intervals (specific of the reagent) This is done by calibrators specific of the test (normally 2 levels).

Quality ControlQuality Control

Quality Control

Quality ControlQuality Control

The instrument software contains all programs necessary for the quality control. Data input, management and security is done by using the keyboard.

Instrument AssemblyInstrument Assembly

Instrument Assembly

Instrument AssemblyInstrument Assembly ELECSYS 1010 is a desk top model and is suitable for a

standard laboratory bench. The instrument can be loaded from the front. The instrument cover top must be closed during the RUN.

The sample/reagent rotor is divided into 6 segments. The

two outer trays can hold samples in so-called primary tubes

of various diameters and heights. Control and calibrator

liquids are normally also positioned in these trays. A

maximum of 6 RackPacks with 2 reagents and one bead

container each are arranged radially between the sample

segments. The two inner trays are provided for secondary

cups. The labels on the primary tubes on the two outer trays

and the RackPacks can be read by a bar-code reader

(BCR).

The rotor assy is equipped with toothed disks and LEDs for

controlling and checking the rotor functions. The sample/

reagent rotor is removable.

The incubation rotor is an aluminum block heated to 37°C.

It can hold 4 identical segments with 32 incubation vessels

each. These incubation vessels are small conical plastic

tubes that hold the incubation material. When preparing the

RUN, the user loads the incubation rotor with the 4 segments.

The incubation rotor is not removable.

Detection ModuleDetection Module

Detection Module

Detection ModuleDetection Module

The ECL measuring cell is located in the detection module.

The photomultiplier (PMT), which is shielded from

electromagnetic radiation by a special housing, as well as

the holder for the pre-amplifier and the high-voltage module

are located above the measuring cell. The magnet with the

drive for the bead capturing is under the measuring cell. The

magnet is moved vertically from below to the bottom of the

measuring cell by a motor/spindle unit. This internal

assembly is incorporated in a housing, which serves as an

optical, electrical and thermal shield. The optimum

temperature for the process of ORIGEN

technology is 28°C. Therefore, the temperature of the entire detection module is set at 28°C.

MFA AssysMFA Assys

MFA Assys

MFA AssysMFA Assys

The instrument is designed to be serviced exclusively from the front, i.e. all components can be taken out and exchanged from the front.

The functional elements (dilutors, rotors, wash stations, bottle temperature assys) have covers that can be easily removed for service. The keyboard is located outside of the closed instrument cover top.

FINAL 2.1 - February 2000

The MFA assys transport the a) sample/reagent from the sample/reagent rotor to

the incubation vessels and

b) incubation material as well as ProCell and CleanCell

to the measuring cell.

The ProCell is a liquid required for generating the ECL signal. CleanCell is an auxiliary liquid used for cleaning the measuring cell and preparing it for the next measurement.

Page 2

Chapter 1

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Elecsys 1010 Service Manual

All components involved in the sample/reagent processes are cleaned with system water.

Arms are mounted on the MFAs. The sample arm holds the sample needle and the bead mixer. The sipper arm holds the sipper needle. The LLD electronic system and the contact sensory system (crash detection) are also located in the arms. The assembly of both MFAs is identical except for the arm adapters.

The contact sensory system consists of mechanical and electronic hardware components. It records the contact of the needle and the bead mixer with a solid surface, e.g. the bottom of the container or a closed RackPack.

Rotation and lifting are controlled by toothed disks / vanes and photo couplers. Horizontal and vertical movements are normally performed in succession.

Bottle TemperatureBottle Temperature

Bottle Temperature

Bottle TemperatureBottle Temperature Elecsys 1010 has 2 bottle temperature systems, one for

ProCell bottle and one for CleanCell bottle. Bottles are refrigerated to approx. 8°C and will reach the desired temperature of 28°C after approx. 1hr. The actual temperature is controlled by NTC resistors in the housing walls.

by two membrane pumps. Another membrane pump is located on the back of the s/r dilutor. This pump has the following functions:

1. Fill the s/r system with system water.

2. Rinse s/r tubing and needle after pipetting.

ValvesValves

Valves

ValvesValves

The flow of system water to the wash stations for bead mixer, s/r needle and sipper needle is controlled by four valves (2-way). The water discharge from the wash stations is controlled by four valves (3-way). Various liquid levels in the wash stations are possible by setting the 3-way valves at different positions. Another valve controls the flow of the measuring material to the measuring cell.

Wash StationsWash Stations

Wash Stations

Wash StationsWash Stations

Elecsys 1010 has four wash stations. There are two wash stations for the s/r needle and one wash station each for the sipper needle and the bead mixer. The wash stations use system water.

LLDLLD

LLD

LLDLLD

DilutorsDilutors

Dilutors

DilutorsDilutors Elecsys 1010 has 2 dilutors. These are glass cylinders in

which pistons are precisely moved at a defined number of increments. When going down, liquids are aspirated. When going up, an exact amount of liquid is discharged by displacement. The direction of the liquid flow can be controlled by reversing valves at the entrance of the dilutors. The dilutors are moved by stepping motors.

The two dilutors have different functions: The needle of the s/r dilutor aspirates the sample, reagents

and microparticles in a defined sequence. The media are separated from the system liquid (H The aspirated material is discharged into the incubation

O) by an air bubble.

vessels through the sample needle. After the sample/ reagent process, the needle is internally cleaned with system water by means of the rinsing pump.

The sipper dilutor is located behind the measuring cell and pulls the incubate, ProCell and CleanCell in a defined sequence through the measuring cell. Then the measurement is performed. After that the needle is internally rinsed with CleanCell. The needle is externally cleaned with system water.

PumpsPumps

Pumps

PumpsPumps

The s/r and the sipper needle have one liquid level detection unit (LLD) each. The s/r-LLD detects samples, reagents, incubate and wash water. The sipper LLD detects incubate, ProCell, CleanCell and wash water.

Clot DetectionClot Detection

Clot Detection

Clot DetectionClot Detection On the sample/reagent side, there is a risk of (blood) clot

formation in the samples. This can be caused by pollution and/or belated clotting of the samples. Changes in the vacuum profile when picking up the samples are identified as clots by means of a differential pressure converter. The appropriate cleaning steps will be taken.

PMTPMT

PMT

PMTPMT The photomultiplier tube (PMT) receives and amplifies the

luminescence signal and converts it to an equivalent voltage. The PMT window is located at a defined distance vertically above the cell work electrode. High-voltage power supply is required for amplification.

High-VoltageHigh-Voltage

High-Voltage

High-VoltageHigh-Voltage High-voltage is used for amplifying the luminescence signal

generated in the measuring cell. The control range spans from 500 V to1100 V.

The instrument has 4 built-in pumps. The waste pump, a peristaltic pump, pumps the measuring material and system liquids into the waste container. The wash stations are fed

FINAL 2.1 - February 2000

PotentiostatPotentiostat

Potentiostat

PotentiostatPotentiostat The potentiostat controls the electrochemical redox process

in the cell.

Chapter 1Page 3

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Elecsys 1010 Service Manual

Measuring CellMeasuring Cell

Measuring Cell

Measuring CellMeasuring Cell

Power Supply AssyPower Supply Assy

Power Supply Assy

Power Supply AssyPower Supply Assy

The cell has three electrodes: the work electrode (on which the microparticles are deposited), the counter electrode and the reference electrode. For the measurement, a constant voltage is applied between work electrode and counter electrode.

It is equipped with an input for input voltages of approx. 80

- 260 volts and 50-60 Hz. The fuses are not accessible to the customer and can only be exchanged by service personnel.

Rotor / Dilutor / MFA DrivesRotor / Dilutor / MFA Drives

Rotor / Dilutor / MFA Drives

Rotor / Dilutor / MFA DrivesRotor / Dilutor / MFA Drives The rotors, dilutor pistons and the MFAs are moved by

stepping motors. In order to avoid the loss of steps, the motions are controlled by photo couplers and toothed disks. Moreover, forward/backward motions can be recognized by two photo couplers placed at an angle of 90°.

TemperaturesTemperatures

Temperatures

TemperaturesTemperatures Elecsys 1010 has 4 systems for setting the temperatures

of liquids. The luminescence liquid is measured at a temperature of

28°C. The temperatures of the incubate picked up by the incubator and the liquids used for the measurements (CleanCell and ProCell) are preset inside the detection module. The immunological reaction occurs at 37°C (incubator temperature).

PCPC

PCPC The PC is a standard PC assembly (CPU 486 DX 2,

66MHz, 8MB RAM) with Roche-owned functions. An 1.44 MB floppy disk drive serves as drive a. The system can be started and reloaded from disk drive a:. A flash-E

PROM serves as a hard disk replacement. The general program and changeable parameters are filed here. The LC display is controlled by the VGA controller.

Barcode Reader / BCRBarcode Reader / BCR

Barcode Reader / BCR

Barcode Reader / BCRBarcode Reader / BCR A bar-code reader (BCR) is attached to the sample/reagent

rotor. It reads and decodes primary sample tubes (on the 1st and 2nd tray on the rotor) and reagent RackPacks whenever the rotor passes the reader and transfers the data to the PC by a built-in RS 232 interface. The reader decodes 2-dimensional (PDF 417) and all standard bar codes.

Software Distribution /ProcessorsSoftware Distribution /Processors

Software Distribution /Processors

Software Distribution /ProcessorsSoftware Distribution /Processors

The entire Elecsys 1010 software is distributed over a total of 8 processors. The master board has a 486 processor. The measuring, sipper, temperature, rotor and s/r modules have an 80196 processor. The incubation module and the clot detection are controlled by an 8051derivative. The keyboard assy and the printer have one CPU each.

Keyboard AssyKeyboard Assy

Keyboard Assy

Keyboard AssyKeyboard Assy The keyboard assy consists of the keyboard, the keyboard

controller, an acoustic signal transmitter, the LC display and some LEDs. The keys are short-stroke touch contact keys. An additional keyboard can be connected to the bottom side of the keyboard assy by using a 5-pin plug (standard keyboard plug). One non-standard function is a signal transmitter (piezo) that can be activated on several frequencies. The display is a 640 x 480 dot LC display. In order to prevent reflections when reading the display in the keyboard assy drawer, it is possible to incline it.

PrinterPrinter

Printer

PrinterPrinter Elecsys 1010 has a thermoprinter with a printing width of

640 pixels. This corresponds to the display resolution. An immediate hard copy output is possible.

FINAL 2.1 - February 2000

Page 4

Chapter 1

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Elecsys 1010 Service Manual

1.1.21.1.2

1.1.2

1.1.21.1.2

Principles of the AnalysisPrinciples of the Analysis

Principles of the Analysis

Principles of the AnalysisPrinciples of the Analysis

See Chapter 5 of the Operator's Manual for details of the test principles used on Elecsys

1010.

FINAL 2.1 - February 2000

Chapter 1Page 5

Page 14

Elecsys 1010 Service Manual

1.1.31.1.3

1.1.3

1.1.31.1.3

Run This chapter describes processes going on in different

tests, e g. the placement of STAT samples during the run, the automatic rerun and the system preparation after start, as well as system evaluation at the end of a run.

Assay Protocols There are 24 independent assay protocols used for

determining the pipetting scheme of tests. Further protocols (no. 24 to no. 26) are used for checking the instrument.

The assay protocols are stored in the system (max. 64) and can only be modified and/or extended by a software update.

In each test a minimum of four liquids, the sample itself, reagent 1, reagent 2 and the microparticles, are processed. The following abbreviations will be used for the liquids:

MP: Microparticles B: Microparticles (test RackPack, assay RackPack) R0: Diluent ("all-purpose diluent", special RackPack) RM: Pretreatment solution for IgM or IgG tests

PS: Prereaction solution (pretreatment solution in RI: Reagent 1 (assay RackPack )

R2: Reagent 2 (assay RackPack ) S: Undiluted sample/ calibrator/ check DL: Diluted sample/ calibrator/ check D: Aspiration into the measuring cell and optical

i: Incubation time

Pipetting SchemePipetting Scheme

Pipetting Scheme

Pipetting SchemePipetting Scheme

(in special RackPack) special RackPack)

detection

5. Aspirate R2 --> discharge R2 into the third incubation vessel.

6. Wait until incubation time i2 is over.

7. Measurement.

One step is taken after the other, allowing for the incubation time. The last step is always the measurement.

The processing of these liquids is determined by the four basic protocols 0 through 3. They define which liquids are processed in which pipetting step. On the basis of the basic protocols, the processing with pretreatment liquids (RO, RM or PS) is defined in the protocols 4 through 23. Read the sequence of pipetting steps within one protocol from left to right. The example shows the following sequence:

1. Aspirate R0 and sample S --> discharge both liquids

2. Aspirate R0 and the diluted sample DL from the first

3. Aspirate microparticles, R1 and the diluted sample

4. Wait until the incubation time i1 is over.

FINAL 2.1 - February 2000

Protocol 9 (dilution with 2 different assays)Protocol 9 (dilution with 2 different assays)

Protocol 9 (dilution with 2 different assays)

Protocol 9 (dilution with 2 different assays)Protocol 9 (dilution with 2 different assays)

into the first incubation container.

incubation vessel --> discharge both liquids into the second incubation vessel.

DL from the second incubation vessel --> discharge all three liquids into the third incubation vessel.

Page 6

Chapter 1

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Elecsys 1010 Service Manual

Assay ProtocolsAssay Protocols

Assay Protocols

Assay ProtocolsAssay Protocols TableTable

Table

TableTable

No. Pipetting Step 0 Inc 0

Pipetting Step

Inc 1

Pipetting Step

Inc 2 Det.

0 B R1 R2 S i1 D X

1 B R1 S i1 R2 i2 D X

2 R1 R2 S i1 B i2 D X

3 R1 S i1 B R2 i2 D X

4 R0 S B R1 R2 DL i1 D

5 R0 S B R1 DL i1 R2 i2 D

6 R0 S R1 R2 DL i1 B i2 D

7 R0 S R1 DL i1 B R2 i2 D

8 R0-> DL1 R0 B R1 R2 DL i1 D

9 R0 S-> DL1 R0 B R1 DL i1 R2 i2 D

10 R0 S-> DL1 R0 R1 R2 DL i1 B i2 D

11 R0 S-> DL1 R0 R1 DL i1 B R2 i2 D

12 PS S i0 B R1 R2 i1 D

13 PS S i0 B R1 i1 R2 i2 D

14 PS S i0 R1 R2 i1 B i2 D

Main assay Remarks

15 PS S i0 R1 i1 B R2 i2 D

16 RM S i0 B R1 R2 DL i1 D

17 RM S i0 B R1 DL i1 R2 i2 D

18 RM S i0 R1 R2 DL i1 B i2 D

19 RM S i0 R1 DL i1 B R2 i2 D

20 RM S-> DL1 RM i0 B R1 R2 DL i1 D

21 RM S-> DL1 RM i0 B R1 DL i1 R2 i2 D

22 RM S-> DL1 RM i0 R1 R2 DL i1 B i2 D

23 RM S-> DL1 RM i0 R1 DL i1 B R2 i2 D

24 R1 R1 D X

25 R1 R2 D X

26 R2 R2 D X

27 R1 B i1 D X

29...

... Reserve

only needed

for instrument

checks,

not part of

the RUN

...63

E-Tab1: Assay Protocols

FINAL 2.1 - February 2000

Chapter 1Page 7

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Elecsys 1010 Service Manual

Pipetting StepsPipetting Steps

Pipetting Steps

Pipetting StepsPipetting Steps The processing of the assay protocols is divided into four

pipetting steps: pipetting step 0, the so-called pretreatment step, pipetting steps1 and 2, and the measuring step. The pipetting steps are divided into partial steps (e.g. pipette R1). The sequence of the partial steps is (regarding the liquid pickup by the s/r needle): R1, R2, B, S.

The pipetting steps / partial steps according to the assay protocols are described below. The pick-up sequence during pretreatment is always: reagent before sample (in both steps).

For each pipetting step and/or measuring step, a generally applicable step can be described. Figures 1 to 3 give an overview of these pipetting steps.

Pipetting Step 0Pipetting Step 0

Pipetting Step 0

Pipetting Step 0Pipetting Step 0 In pipetting step 0 the sample is pretreated. It has one or two

increments. In the figure, these increments are called "Block 1 and 2".

- Block 1 is passed through for protocols 4 through 23.

- Block 2 is passed through for protocols 8 through 11 and 20 through 23.

Each block consists of

- aspiration of the separation air bubble

- aspiration of the pretreatment liquid from the sample rotor

- washing in wash station 1

- aspiration of the sample

- washing and rinsing in wash station 1 or rinsing in wash station 2, rehomogenizing of the microparticles and washing

Rinsing and washing in wash station 2 with simultaneous rehomogenizing of the microparticles can only be performed one time, always at the end of a pipetting step.

The difference between block 1 and block 2 is the aspiration of the diluted sample from the incubation rotor.

- In block 1, the sample is aspirated from the sample rotor, and the samples are discharged into the first incubation vessel.

- In block 2, the sample is aspirated from the first

incubation vessel, and the liquids are discharged into the second incubation vessel.

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Pipetting Step 0Pipetting Step 0

Pipetting Step 0

Pipetting Step 0Pipetting Step 0

Sample rotor Incubation rotor

Block 1Block 1

Block 1

Block 1Block 1

Aspirate

Block 2Block 2

Block 2

Block 2Block 2

Aspirate

Wash and rinse in

wash station 1

Aspirate separation air bubble

R0 or PS or RM

Aspirate sample by using

LLD

Wash in wash station 1

Aspirate sample by using

LLD

Discharge

Aspirate separation air bubble

R0 or RM

Aspirate pretreatment

liquid by using LLD

Discharge

Wash and rinse in

wash station 2 and

rehomogenize microparticles

Wash and rinse

in wash station 1

Figure 1: Pipetting step 0

FINAL 2.1 - February 2000

Wash in wash station 1

Aspirate pretreated sample

by using LLD

Discharge

Aspirate

Discharge

Wash and rinse in

wash station 2 and

rehomogenize microparticles

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Elecsys 1010 Service Manual

Pipetting Step 1Pipetting Step 1

Pipetting Step 1

Pipetting Step 1Pipetting Step 1 Pipetting step 1 is also divided into blocks and always

starts with block 1.

- Aspirate the separation air bubble.

In blocks 2, 3 and 4, reagents are aspirated. All three blocks are passed through in the following sequence:

- Aspiration of R1, R2 or microparticles.

- Discharging of fluids after the last reagent has been picked up and the sample pretreated with PS. The sample pretreated with PS will be further processed in block 6.

- Washing in wash station 1.

The assay protocols determine which and how many of the blocks will be passed through in pipetting step 1.

In block 5, the sample is aspirated. The pretreated sample DL is

- aspirated from the first incubation vessel and is discharged into a second incubation vessel in block 6, if it has been pretreated with R0 or RM in one increment (see pipetting step 0).

- aspirated from the second incubation vessel and is discharged into a third incubation vessel in block 6, if it has been pretreated with R0 or RM in two increments (see pipetting step 0).

If sample S has not been pretreated, it will be aspirated from the sample rotor and discharged into the first incubation vessel in block 6.

In block 6, the liquids are discharged into the incubation rotor, and the s/r needle is washed and rinsed. If the sample has been pretreated with PS, the aspirated liquids will be added to the first incubation vessel (see pipetting step 0). The rehomogenizing of the microparticles and the washing /rinsing in wash station 2 will be performed if in the next cycle microparticles are pipetted in one pipetting step 1.

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Pipetting Step 1Pipetting Step 1

Pipetting Step 1

Pipetting Step 1Pipetting Step 1

Sample rotor Incubation rotor

Block 1Block 1

Block 1

Aspirate

Block 1Block 1

Block 2Block 2

Block 2

Block 2Block 2

Block 3Block 3

Block 3

Block 3Block 3

Aspirate separation air bubble

Aspirate reagent 1

by using LLD

Wash in wash station 1

Aspirate reagent 2

by using LLD

Aspirate

Block 5Block 5

Block 5

Block 5Block 5

Aspirate

Block 6Block 6

Block 6

Block 6Block 6

Block 4Block 4

Block 4

Block 4Block 4

Aspirate sample by

using LLD (clot and

foam detection)

Wash and rinse in wash station 1

Wash in wash station 1

Microparticles

Aspirate microparticles

by using LLD

Wash in wash station 1

Discharge

Wash and rinse in wash

station 2 and rehomogenize

DLS

Aspirate pretreated sample by using LLD

microparticles

Aspirate

Discharge sample pretreated with PS

Figure 2: Pipetting step 1

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Pipetting Step 2Pipetting Step 2

Pipetting Step 2

Pipetting Step 2Pipetting Step 2 Pipetting step 2 is divided into 4 blocks. Like pipetting

step 1, it always starts with block 1:

- Aspirate the separation air bubble.

In blocks 2 and 3, reagents are aspirated. Both blocks are passed through in the following sequence:

- Aspirate R2 or microparticles.

- Discharge liquid into the incubation rotor after the last reagent has been picked up.

- Wash in wash station 1.

The assay protocols determine which and how many of the blocks will be passed through in pipetting step 2.

In block 4, the liquids are discharged into the incubation rotor, and the s/r needle is washed and rinsed. The liquids will be

- added to the first incubation vessel, if the sample has not been pretreated or pretreated with PS.

- added to the second incubation vessel, if the sample has been pretreated with R0 or RM in one increment.

- added to the third incubation vessel, if the sample has been pretreated with R0 or RM in two increments.

The rehomogenizing of the microparticles and the washing /rinsing in wash station 2 will be performed if in the next cycle microparticles are pipetted in one pipetting step 1.

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Pipetting Step 2Pipetting Step 2

Pipetting Step 2

Pipetting Step 2Pipetting Step 2

Sample rotor Incubation rotor

Block 1Block 1

Block 1

Aspirate

Block 1Block 1

Block 2Block 2

Block 2

Block 2Block 2

Aspirate separation air bubble

Aspirate reagent 2

by using LLD

Wash in wash station 1

Aspirate

Block 4Block 4

Block 4

Block 4Block 4

Block 3Block 3

Block 3

Block 3Block 3

Wash and rinsei n wash station 1

Microparticles

Aspirate microparticles by

using LLD

Wash in wash station 1

Discharge

wachen und spülen in

Wash and rinse in

wash station 2 and

rehomogenize microparticles

Figure 3: Pipetting step 2

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Measuring StepMeasuring Step

Measuring Step

Measuring StepMeasuring Step Measuring step actions take place around the measuring

cell, e.g. in the incubator, sipper needle, measuring cell or in the sipper system dilutor. The measuring step has the following increments:

- Pick-up of the incubate ( - sampling, pick -up ) (preconditioning with ProCell included).

- Transport of the incubate with ProCell (preconditioning with ProCell included).

- Capturing with ProCell

- Washing with ProCell

- Measuring -> optical measurement

- Pick-up of CleanCell solution for cleaning 1

- Pick-up of air and CleanCell alternately

- Solution for cleaning 2

- Pick-up of ProCell for cleaning 3

- Pick-up of ProCell for post -conditioning

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1.1.3.11.1.3.1

1.1.3.1

1.1.3.11.1.3.1

Timing DiagramTiming Diagram

Timing Diagram

Timing DiagramTiming Diagram

FINAL 2.1 - February 2000

diag1.tif

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Page 16

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diag3.tif

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1.21.2

1.2

1.21.2

Analyzer dimensions Height: 620 (mm)

Electrical Supply voltage 100 - 240 (V) AC at 50/60 (Hz)

Environmental conditions Temperature 18 (°C) to 32 (°C)

System SpecificationSystem Specification

System Specification

System SpecificationSystem Specification

Depth: 780 (mm)

Width: 960 (mm)

Weight approx. 110 (kg)

Power consumption max 0.61 (kVA)

Fuse circuit 16 (A) time-lag at 230 (V) AC

Heat generation

Ambient temperature note change during one batch run

approx. 2000 (kJ/h) resp. 481 (kcal/h) resp. 1912 (BTU/h)

max. ± 3 (°C)

rel. humidity 20 (%) to 85 (%) without condensation

Noise level according to DIN 43635

Water supply Water tank approx. 4,2 (l)

Waste water connection

Throughput ECL measurements approx. 50 (tests/h)

Samples Sample volume per test 10 (µl) to 50 (µl)

Continuous operation max. 60 (dBA)

Peak level max. 65 (dBA)

Water quality (conductivity) sub-micron filtered <10 µS/cm

Water consumption approx. 3 (l) for 128 test

Waste container for measuring material, system water, ProCell, CleanCell

Sample detection

Sample rotor for routine samples, calibrators and controls

Usable sample bar codes

approx. 5 (l)

by Liquid Level Sensor and Clot Detector of the sample / reagent needle

42 positions for primary tubes, 18 positions for secondary cups

2 positions for STAT samples

NW7 (Codabar), Code 39, Code 128, Interleave 2 of 5

Reagent Reagent capacity 6 reagent channels

by Liquid Level Sensor of the sample/ reagent needle

E-Tab2

FINAL 2.1 - February 2000

Reagent detection

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Bottle volume for CleanCell and ProCell 380 (ml)

Reagent ID by 2-dim. bar code (PDF 417)

Incubator Incubator capacity 128 plastic assay cups (4 x 32)

Volume of assay cups 200 (µl)

ambient temperature 18°C to 20°C

Incubation temperature

Incubation time 9 / 18 (min)

37°C + 0.3°C - 0.8°C ambient temperature 20°C to 32°C 37°C + 0.3°C - 0.3°C

Measuring system Measuring method

Calibration method 2 point calibration

PC Disk drive Floppy disk 3,5" / 1.44 MB

Interfaces

LCD

Thermoprinter Paper width 110 (mm)

E-Tab3

Integral measurement of luminescence signal

1 Centronics for printer, 1 RS 232 for laboratory EDP

Black-and-white VGA LCD with 640 x 480 pixels

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1.3.3 Precautions and Hazards1.3.3 Precautions and Hazards

1.3.3 Precautions and Hazards

1.31.3

1.3

1.31.3

The data and information provided in this manual correspond to the state of knowledge existing at the time of introducing the Elecsys 1010 onto the market. Any important changes will be taken into account in the next edition of this manual.

The respective packaging leaflet should be regarded as authoritative.

Operator Precautions andOperator Precautions and

Operator Precautions and

Operator Precautions andOperator Precautions and HazardsHazards

Hazards

HazardsHazards

1.3.3 Precautions and Hazards1.3.3 Precautions and Hazards

All electrical equipment is potentially hazardous. Never remove covers without first ensuring that it is isolated from the AC supply, unless specific maintenance instructions or repairs are being carried out by authorized Roche Diagnostics personnel.

The hard- and software is subject to a program of continuous evaluation and improvement and, therefore, may be changed in the future. This also concerns service requirements.

This service manual was created for the telephone and technical service staff.

1.3.1 Contact Persons1.3.1 Contact Persons

1.3.1 Contact Persons

1.3.1 Contact Persons1.3.1 Contact Persons

Technical Product Management and Support Department: LI-TT

Phone: 0621 / 759 / 3227

8802

Fax No: 0621/ 759 / 4591

Logistics Hotline (RA):

Phone: 0621 / 759 / 4389 Fax No.: 0621 / 759 / 4613

8093

When calling from abroad, drop the "0" and add the country code (+ 49).

1.3.2 Proved Security1.3.2 Proved Security

1.3.2 Proved Security

1.3.2 Proved Security1.3.2 Proved Security

All samples and reagents should be treated with caution accorded to those known to contain pathogenic organisms. Similarly, the cleaning of component part of Elecsys 1010 should be done with respect to human health.

Warning:Warning:

Warning:

Warning:Warning: All components used on Elecsys 1010 must be regarded

as potentially dangerously contaminated when doing repair work. Use rubber gloves or double gloves whenever cleaning or sterilizing components. the most frequently used components (tubings, cuvette, measuring chamber flap, sip. lever and waste container) should be cleaned and treated with a suitable disinfecting solution (75% alcohol) prior to doing any service work.

Disinfect and wash hands after work is completed. This instrument has been constructed and checked in

accordance with Standards IEC 1010. When the instrument leaves our factory it is in perfect order from the point of view of work safety. To keep it that way and to ensure safe operation the user must follow the instructions and warnings given in the operation instruction manual.

The electrical protection of the apparatus to Class I (it has a protective earth).

This instrument has been constructed according to the regulations of DIN IEC 601, part: "Security of Electromedical Instruments: General Guidelines" and left our factory in perfect condition regarding work safety.

The instrument obtained the GS mark for proved security from the TÜV.

In order to ensure safe operation the user must follow the instructions and warnings given in the instruction manual.

This instruments meets protection 1 (earth conductor wire).

FINAL 2.1 - February 2000

The power plug must only be inserted into a socket that has a protective contact. The protection must not be abolished by using an extension lead that does not have a protective earth wire.

Warning:Warning:

Warning:

Warning:Warning: Any break in the earth wire inside or outside the apparatus

and any loose connection of the earth wire can make the operation of the apparatus dangerous. A deliberate break or interruption is not allowed.

When the housing is opened or components are being removed (except when this can be done by hand), live parts may be exposed. Connection may also be live.

Therefore, if the carrying out of an adjustment, service or repair on the open apparatus in the live state is unavoidable, this must be done by an expert who is familiar with the dangers involved.

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Make sure you only use fuses of the specified type and rated amperage when replacing. Repaired fuses must not be used and the fuse holder must not be bypassed.

If you have any reason to believe that the instrument can no longer operate safely, take it out of use and make sure no one can use it accidentally.

It must be assumed that safe operation is no longer possible when the instrument:

- shows visible signs of damage

- fails to operate

- has been stored under unfavourable conditions for a fairly long time

- has been transported under rough conditions

The Elecsys 1010 should be used by appropriately qualified persons only.

Warning:Warning:

Warning:

Warning:Warning: In order to avoid electrostatic charging when working on the

electronics, use a grounding strap and a grounding mat. For more information, please refer to operator manual.

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1.4 Service Concept1.4 Service Concept

1.4 Service Concept

1.4 Service Concept1.4 Service Concept

1.4.11.4.1

1.4.1

1.4.11.4.1

From the early stage of development, Elecsys 1010 was designed for simple error detection and easy exchangeability of modules. This gives the service workshops the possibility of a fast and easy repair of the instrument on service level A (module level). No big stock or expensive equipment is necessary and service technicians are easier to train. Also, a permanent technical improvement in layout and components took and takes place for better productivity and economic production.

On repairable modules the quality and function is always provided by the manufacturer according to the latest technology. This keeps Elecsys 1010 always on the highest quality level.

The exchange price for modules will be kept on a low level to guarantee repairs, on an economical basis.

1.4.21.4.2

1.4.2

1.4.21.4.2

Service LevelService Level

Service Level

Service LevelService Level

RA-Procedure (Replacement ofRA-Procedure (Replacement of

RA-Procedure (Replacement of

RA-Procedure (Replacement ofRA-Procedure (Replacement of defective parts)defective parts)

defective parts)

defective parts)defective parts)

- All defective parts ( non-"R" and "A" parts ) should be kept on stock for a period of 7 months. In case the manufacturer needs the part for investigation it will be requested from Mannheim.

- All parts returned to Mannheim and not requested by Mannheim will be send back at the expense of the countries.

- The RA claim for warranty has to be in Mannheim no later than 8 weeks after the problem date.

Exclusion of warrantyExclusion of warranty

Exclusion of warranty

Exclusion of warrantyExclusion of warranty The aforementioned warranties do not apply in case of

improper use, handling, transportation or storage, faulty installation, repair or maintenance, chemical influence or contamination as well as damages resulting from that, failure to follow operating instructions, alterations or modifications of instruments or parts thereof not authorized or recommended by RD GmbH and resulting damages, normal wear and tear and in case of other circumstances beyond the control of RD GmbH.

Handling of repairsHandling of repairs

Handling of repairs

Handling of repairsHandling of repairs As a general rule, all instrument repairs should be carried

out by authorized and trained personnel only.

Warranty period for instruments and spare partsWarranty period for instruments and spare parts

Warranty period for instruments and spare parts

Warranty period for instruments and spare partsWarranty period for instruments and spare parts The warranty period for instruments is 16 months starting

with the date of shipment ex works Mannheim/Federal Republic of Germany or 12 months starting with the date of the first installation, whichever period is shorter. The warranty period for spare parts is 6 months from installation date of the part, however not longer than 24 months after having delivered ex works Mannheim/Federal Republic of Germany. Note: In case the instrument has a remaining warranty period of more than 6 months, the parts remain under warranty until the warranty period of the instrument expires.

Handling of warranty claimsHandling of warranty claims

Handling of warranty claims

Handling of warranty claimsHandling of warranty claims The warranty claim has to be handled via Return

Authorization procedure or accepted equivalent. Please answer all the questions on the RA form with the greatest care.Especially a detailed fault description is needed or the warranty claim will not be accepted by the manufacturer. Complete instruments are not accepted unless this has been agreed with the service department of the relevant product group responsible at RD GmbH.

Repair of parts marked with "R"Repair of parts marked with "R"

Repair of parts marked with "R"

Repair of parts marked with "R"Repair of parts marked with "R" Parts which are economically worth repairing are marked

with "R" in the spare parts price list. New and repaired parts could be recognized by different material numbers (language version).

(e.g. new part: 1234567-001, repaired part: 1234567-984) Repaired parts should be ordered together with new parts

via the order processing department in Mannheim (OUVDG). Parallel to the ordering process of a repaired part, the defective part should be returned together with the filled RA form (giving full details of the defect and marked choice box with repair) to Logistic Instruments (Goods Receipt) in MA-Wohlgelegen (LI-GS). Repair of instrumentsComplete instruments are not accepted for replacement or repair unless this has been agreed with the product group responsible at RD GmbH. Before replacement or repair can take place, the validity of the request must be examined and the question of costs must be settled in a written agreement with RD GmbH.

Terms of deliveryTerms of delivery

Terms of delivery

Terms of deliveryTerms of delivery

Important informationImportant information

Important information

Important informationImportant information

- Only parts marked with "A" in the price list are generally accepted under warranty.

- Only return those parts marked with "R" in the spare parts price list.

- Warranty claim for „R“ parts will be accepted, if the part was returned to Mannheim.

FINAL 2.1 - February 2000

Shipments to the countries with the routine truck are c.i.f./ shipments outside this procedure are ex works Mannheim. Emergency shipments require additional costs to be charged.

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Handling of costsHandling of costs

Handling of costs

Handling of costsHandling of costs „Repaired“-parts (Material-No. 1234567-984) are shipped

at a repair price. In case the defective parts are not returned within 3 or 8 weeks for european or oversea countries after ordering the repaired part, the countries will be charged later on with the difference to the new price.After the receipt of a warranty request for „A“-parts, RDG will credit 100 % of the currently effective ex MA price.In case the manufacturer does not accept the warranty request, the countries will be charged lateron with the R-price for Rparts and the new price for non R-parts.

RA formRA form

RA form

RA formRA form Return Authorization. Please answer all the questions on

the RA form with the greatest care and sign the form.

- Country code

- Problem date

- Type of instrument

- Serial no. of the instrument

- Installation date of instrument

- Defective instrument or spare part

- Part number and material number of the spare part

- Old / new serial no.

- Fault description

- Alarm code

- Service / workshop report no.

In case of instrument out of warrantyIn case of instrument out of warranty

In case of instrument out of warranty

In case of instrument out of warrantyIn case of instrument out of warranty

- Installation date of spare part. All returned parts should be individually labeled with the

corresponding RA No. and shipped together with the completed RA form to:

Roche Diagnostics GmbH Logistic Instruments RA Management Friedrich Ebert Str. 100 D - 68167 Mannheim Germany

FINAL 2.1 - February 2000

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Elecsys 1010 Service Manual

RA Form:RA Form:

RA Form:

RA Form:RA Form: A copy of the RA Form is shown below.

Roche Diagnostics

Friedrich-Ebert-Strasse 100 Telefon : +49 (621) 759 81 84

D-68167 Mannheim Fax : +49 (621) 759 80 93

Germany

Return Authorization

No.:

Country code:

Date:

Instrument:

Serial No.:

Installation date:

Spare Part:

Customer: Address:

(will be filled in by BM)

Part No.: Qty.: Part Name: Repair Comments

Mat.-No.: Warranty

Installation date of Spare Part: Warranty Repair

OLD serial No.: Modification

NEW serial No.: Replacement

Fault Description:

Alarm Code:

Service Report No.: Workshop Report No.:

Place: Date: Signature:

Remarks

(will be filled in byRD)

NOS Credit FC

Fig.: RA.eps

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1010

MaintenanceMaintenance

Maintenance

MaintenanceMaintenance

10.110.1

10.1

10.110.1

10.210.2

10.2

10.210.2

10.310.3

10.3

10.310.3

10.410.4

10.4

10.410.4

IntroductionIntroduction

Introduction

IntroductionIntroduction

10.1.110.1.1

10.1.1

10.1.110.1.1

Maintenance ScheduleMaintenance Schedule

Maintenance Schedule

Maintenance ScheduleMaintenance Schedule

Bi-weekly Analyzer MaintenanceBi-weekly Analyzer Maintenance

Bi-weekly Analyzer Maintenance

Bi-weekly Analyzer MaintenanceBi-weekly Analyzer Maintenance

10.3.110.3.1

10.3.1

10.3.110.3.1

10.3.210.3.2

10.3.2

10.3.210.3.2

10.3.310.3.3

10.3.3

10.3.310.3.3

10.3.410.3.4

10.3.4

10.3.410.3.4

10.3.510.3.5

10.3.5

10.3.510.3.5

Maintenance, As RequiredMaintenance, As Required

Maintenance, As Required

Maintenance, As RequiredMaintenance, As Required

10.4.110.4.1

10.4.1

10.4.110.4.1

10.4.210.4.2

10.4.2

10.4.210.4.2

10.4.310.4.3

10.4.3

10.4.310.4.3

Cleaning MaterialsCleaning Materials

Cleaning Materials

Cleaning MaterialsCleaning Materials

Perform SYSTEM CLEANING INTENSIVEPerform SYSTEM CLEANING INTENSIVE

Perform SYSTEM CLEANING INTENSIVE

Perform SYSTEM CLEANING INTENSIVEPerform SYSTEM CLEANING INTENSIVE Clean the Microparticle MixerClean the Microparticle Mixer

Clean the Microparticle Mixer

Clean the Microparticle MixerClean the Microparticle Mixer Clean the Sipper ProbeClean the Sipper Probe

Clean the Sipper Probe

Clean the Sipper ProbeClean the Sipper Probe Clean the S/R ProbeClean the S/R Probe

Clean the S/R Probe

Clean the S/R ProbeClean the S/R Probe Perform CELL CLEANING NORMALPerform CELL CLEANING NORMAL

Perform CELL CLEANING NORMAL

Perform CELL CLEANING NORMALPerform CELL CLEANING NORMAL

Clean the Analyzer Surfaces and CoverClean the Analyzer Surfaces and Cover

Clean the Analyzer Surfaces and Cover

Clean the Analyzer Surfaces and CoverClean the Analyzer Surfaces and Cover Replacing Printer PaperReplacing Printer Paper

Replacing Printer Paper

Replacing Printer PaperReplacing Printer Paper Clean the Rinse StationsClean the Rinse Stations

Clean the Rinse Stations

Clean the Rinse StationsClean the Rinse Stations

__________________________________________________________________________________________

_____________________________________________

__________________________________________________________________________________________

_____________________________________________

__________________________________________________________________________________________

________________________________________________________________________

____________________________________

________________________________________________________________________

______________________________________________________

___________________________

______________________________________________________

__________________________________________________

_________________________

__________________________________________________

________________________________________________________________________

____________________________________

________________________________________________________________________

__________________________________________________________________________________

_________________________________________

__________________________________________________________________________________

________________________________________________________________________________________

____________________________________________

________________________________________________________________________________________

____________________________________________________________

______________________________

____________________________________________________________

________________________________________________________________

________________________________

________________________________________________________________

____________________________________________________

__________________________

____________________________________________________

________________________________________________________________________________

________________________________________

________________________________________________________________________________

______________________________________________________________________________

_______________________________________

______________________________________________________________________________

1010

1010 1010

1010

55 66

66 66

66 77

77 88

10.510.5

10.5

10.510.5

10.6 Preventive Maintenance10.6 Preventive Maintenance

10.6 Preventive Maintenance

10.6 Preventive Maintenance10.6 Preventive Maintenance

10.710.7

10.7

10.710.7

Half-yearly, Yearly, Special Maintenance Half-yearly, Yearly, Special Maintenance

Half-yearly, Yearly, Special Maintenance

Half-yearly, Yearly, Special Maintenance Half-yearly, Yearly, Special Maintenance

Maintenance MaterialsMaintenance Materials

Maintenance Materials

Maintenance MaterialsMaintenance Materials

______________________________________

___________________

______________________________________

____________________________________________________________________

__________________________________

____________________________________________________________________

______________________________________________________________________

___________________________________

______________________________________________________________________

1212

2020

2222

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1010

10.110.1

10.1

10.110.1

Before maintenance procedures are performed on the analyzer, refer to the warnings in Section 1.4, Potential Hazard and Safety Precautions, of the Reference Guide.

All analyzer components that can come in contact with biological substances are potentially biohazardous and can endanger the health of an operator. Therefore, only perform care and maintenance procedures according to national, international and general laboratory safety regulations.

Analyzer care entails all procedures that are periodically performed by the operator. These procedures, listed below, serve to ensure a problem-free run and thus the correct operation of the Elecsys 1010 analyzer. Refer to the maintenance schedule on the next page. The correct operation of the analyzer can only be ensured when the maintenance procedures are performed periodically. Regular care and maintenance avoids analyzer downtimes, failures, and measurement and run problems.

MaintenanceMaintenance

Maintenance

MaintenanceMaintenance

IntroductionIntroduction

Introduction

IntroductionIntroduction

WARNINGWARNING

WARNING

WARNINGWARNING

10.1.110.1.1

10.1.1

10.1.110.1.1

The following materials are generally required for care and maintenance procedures:

- Alcohol (70% isopropyl alcohol)

- Normal common disinfectant

- Distilled/deionized water

- Rubber gloves

- 0.5 % Edisonite

- Cleaning brush

- Cleaning solution (SysClean)

- Cloths (clean, lint-free, absorbent)

- Ultrasonic bath (if available; use only when the

Cleaning MaterialsCleaning Materials

Cleaning Materials

Cleaning MaterialsCleaning Materials

(to clean sampling system)

rinse stations and probes are highly contaminated; 15 minutes with distilled water, 25000 Hz, at 60 °C)

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10.210.2

10.2

10.210.2

Detailed descriptions of the maintenance procedures listed below can be found later in this chapter.

DailyDaily

Daily

DailyDaily

Bi-weeklyBi-weekly

Bi-weekly

Bi-weeklyBi-weekly

As requiredAs required

As required

As requiredAs required

Maintenance ScheduleMaintenance Schedule

Maintenance Schedule

Maintenance ScheduleMaintenance Schedule

None

Perform SYSTEM CLEANING INTENSIVE Clean the microparticle mixer Clean the sipper probe Clean the S/R probe Perform CELL CLEANING NORMAL

Clean the analyzer surfaces and cover Replace printer paper Clean the rinse stations

RD Service onlyRD Service only

RD Service only

RD Service onlyRD Service only

Perform CELL CLEANING INTENSIVE

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10.310.3

10.3

10.310.3

10.3.110.3.1

10.3.1

10.3.110.3.1

Perform the SYSTEM CLEANING INTENSIVE function to prevent deposits and bacterial contamination. The analyzer displays a message when a maintenance procedure is required. This function should be performed on a bi-weekly basis.

NoteNote

Note

NoteNote The frequency with which the cleaning function is performed is dependent on the test throughput and can be set thus allowing longer maintenance intervals to be defined.

Safety PrecautionsSafety Precautions

Safety Precautions

Safety PrecautionsSafety Precautions None.

Materials NecessaryMaterials Necessary

Materials Necessary

Materials NecessaryMaterials Necessary Edisonite.

Bi-weekly Analyzer MaintenanceBi-weekly Analyzer Maintenance

Bi-weekly Analyzer Maintenance

Bi-weekly Analyzer MaintenanceBi-weekly Analyzer Maintenance

Perform SYSTEM CLEANINGPerform SYSTEM CLEANING

Perform SYSTEM CLEANING

Perform SYSTEM CLEANINGPerform SYSTEM CLEANING INTENSIVEINTENSIVE

INTENSIVE

INTENSIVEINTENSIVE

1. Press the UTILITIES key and then the MAINTENANCE key. The MAINTENANCE, SYSTEM CLEANING screen is displayed.

2. Press the SYSTEM CLEANING INTENSIVE key and follow the instructions displayed on screen.

3. When all requirements that are displayed on screen have been fulfilled, press the START key. Elecsys 1010 starts the cleaning process and displays the time remaining until the cleaning process is complete. After half of the necessary time of the cleaning process you have to empty the waste container and clean it with distilled water. Press PAUSE (at the bottom right of the screen) to interrupt the cleaning process. The process can be continued by pressing CONTINUE (same key).

4. Elecsys 1010 displays a message when the cleaning process is complete. SYSTEM CLEANING INTENSIVE is now complete.

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10.3.210.3.2

10.3.2

10.3.210.3.2 MixerMixer

Mixer

MixerMixer

Wipe the microparticle mixer clean every second week to remove any contamination. Do not bend the microparticle mixer.

Safety PrecautionsSafety Precautions

Safety Precautions

Safety PrecautionsSafety Precautions The analyzer must be switched off. Ensure that the normal laboratory safety precautions are heeded and wear rubber gloves.

Materials NecessaryMaterials Necessary

Materials Necessary

Materials NecessaryMaterials Necessary Absorbent, lint-free cloth and alcohol.

Clean the MicroparticleClean the Microparticle

Clean the Microparticle

Clean the MicroparticleClean the Microparticle

10.3.310.3.3

10.3.3

10.3.310.3.3

Wipe the sipper probe clean every second week to remove any contamination.

Safety PrecautionsSafety Precautions

Safety Precautions

Safety PrecautionsSafety Precautions The analyzer must be switched off. The sipper probe is potentially biohazardous. Ensure that the normal laboratory safety precautions are heeded and wear rubber gloves.

Materials NecessaryMaterials Necessary

Materials Necessary

Materials NecessaryMaterials Necessary Absorbent, lint-free cloth and alcohol.

NoteNote

Note

NoteNote Water droplets on the tip of the probe indicate possible contamination. This can affect the LLD function which may lead to analyzer problems.

Clean the Sipper ProbeClean the Sipper Probe

Clean the Sipper Probe

Clean the Sipper ProbeClean the Sipper Probe

1. Power off the analyzer. Gently raise the S/R arm up and out of rinse well.

2. Rotate the sample/reagent arm manually so that the microparticle mixer can be easily accessed.

3. Clean the mixer with a lint-free cloth soaked in alcohol.

CAUTIONCAUTION

CAUTION

CAUTIONCAUTION Handle the microparticle mixer with care. Do not bend. A bent mixer can cause analyzer errors.

1. Power off the analyzer. Gently raise the sipper probe up and out of the rinse well.

2. Rotate the sipper arm manually so that the probe can be easily accessed.

3. Clean the probe with a lint-free cloth soaked in alcohol.

CAUTIONCAUTION

CAUTION

CAUTIONCAUTION Handle the sipper probe with care. Do not bend. A bent sipper probe can cause a run to stop as well as analyzer errors and incorrect results.

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10.3.410.3.4

10.3.4

10.3.410.3.4

Wipe the S/R probe clean every second week to remove contamination.

Safety PrecautionsSafety Precautions

Safety Precautions

Safety PrecautionsSafety Precautions The analyzer must be switched off. The S/R probe is potentially biohazardous. Ensure that the normal laboratory safety precautions are heeded and wear rubber gloves.

Materials NecessaryMaterials Necessary

Materials Necessary

Materials NecessaryMaterials Necessary Absorbent, lint-free cloth and alcohol.

NoteNote

Note

NoteNote Water droplets on the tip of the probe indicate possible contamination. This can affect the LLD function (Liquid Level Detection) which may lead to analyzer problems.

Clean the S/R ProbeClean the S/R Probe

Clean the S/R Probe

Clean the S/R ProbeClean the S/R Probe

1. Power the analyzer off. Gently raise the S/R probe up and out of the rinse well.

2. Rotate the S/R arm manually so that the S/R probe can be easily accessed.

3. Clean the probe with a lint-free cloth soaked in alcohol.

CAUTIONCAUTION

CAUTION

CAUTIONCAUTION Handle the S/R probe with care. Do not bend. A bent S/ R probe can cause a run to stop as well as analyzer errors and incorrect results

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10.3.510.3.5

10.3.5

10.3.510.3.5

Perform the CELL CLEANING NORMAL function every second week. CELL CLEANING NORMAL cleans the sipper flow path and measuring cell.

Safety PrecautionsSafety Precautions

Safety Precautions

Safety PrecautionsSafety Precautions Ensure that the normal laboratory safety precautions are heeded and wear rubber gloves and protection glasses.

Materials NecessaryMaterials Necessary

Materials Necessary

Materials NecessaryMaterials Necessary Cleaning solution = ISE (Cleaning solution) SYSCLEAN.

Perform CELL CLEANING NORMALPerform CELL CLEANING NORMAL

Perform CELL CLEANING NORMAL

Perform CELL CLEANING NORMALPerform CELL CLEANING NORMAL

1. Press the UTILITIES key and then the MAINTENANCE key. The MAINTENANCE, SYSTEM CLEANING screen is displayed.

2. Press the CELL CLEANING NORMAL key and follow the instructions displayed on screen.

3. Place a cleaned ProCell bottle with 60ml SysClean (= ISE Cleaning solution) in ProCell position of ProCell/CleanCell set 2.This is a tempory solution until the cleaning adapter is available.

4. Press the START key. Elecsys 1010 starts the cleaning process and displays the time remaining until the process is complete. Press PAUSE (at the bottom right of the screen) to interrupt the cleaning process. The process can be continued by pressing CONTINUE (same key).

5. Elecsys 1010 displays a message when the cleaning process is complete. Remove the automatic cleaning utensils at this point (e.g. SysClean and clean out the water container with distilled or deionized water. Place the water container back into its location. The container must audibly lock into place. Place also a new ProCell bottle in the ProCell position and update the INVENTORY, REAGENT screen. CELL CLEANING NORMAL is now complete.

CAUTIONCAUTION

CAUTION

CAUTIONCAUTION If the cell cleaning program is interrupted, e.g. instrument cover opened, any fatal error, etc., a PRIME& RINSE has to be started immediately to remove the ISE Cleaning

NoteNote

Note

NoteNote Do not to use the CELL CLEANING INTENSIVE function. It is reserved only for the service personnel.

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10.410.4

10.4

10.410.4

10.4.110.4.1

10.4.1

10.4.110.4.1 Surfaces and CoverSurfaces and Cover

Surfaces and Cover

Surfaces and CoverSurfaces and Cover

Clean the analyzer surfaces and the cover as required (e.g. after liquid is spilled) to prevent contamination.

Safety PrecautionsSafety Precautions

Safety Precautions

Safety PrecautionsSafety Precautions The analyzer must be in Stand-by mode. Ensure that the normal laboratory safety precautions are followed and wear rubber gloves.

Materials NecessaryMaterials Necessary

Materials NecessaryMaterials Necessary Paper towels and lint-free cloths soaked in normal disinfectant.

10.4.210.4.2

10.4.2

10.4.210.4.2

Check the availability of paper for the printer daily to avoid interruptions to the printout of results.

Maintenance, As RequiredMaintenance, As Required

Maintenance, As Required

Maintenance, As RequiredMaintenance, As Required

Clean the AnalyzerClean the Analyzer

Clean the Analyzer

Clean the AnalyzerClean the Analyzer

Replacing Printer PaperReplacing Printer Paper

Replacing Printer Paper

Replacing Printer PaperReplacing Printer Paper

1. Gain access to the printer by pulling the cover from the bottom side up (lower left of the analyzer).

2. Take hold of the roller and pull it out towards the front.

3. Push the metal roller into the new paper roll and place it back into position. The paper must be oriented so it feeds from the top of the roll.

4. Feed the paper over the front roller and through the slot, as illustrated. An automatic feeder feeds the paper out through the front paper feed slot in the cover.

5. Close the cover.

10.4.310.4.3

10.4.3

10.4.310.4.3

Clean all four rinse stations every two months to prevent contamination.

Safety PrecautionsSafety Precautions

Safety Precautions

Safety PrecautionsSafety Precautions The analyzer must be switched off. Ensure that the normal laboratory safety precautions are followed and wear rubber gloves.

Materials NecessaryMaterials Necessary

Materials Necessary

Materials NecessaryMaterials Necessary Cleaning brush, water and an ultrasonic bath (if available).

Clean the Rinse StationsClean the Rinse Stations

Clean the Rinse Stations

Clean the Rinse StationsClean the Rinse Stations

1. Unscrew (counter-clockwise) the knurled screws on all four rinse stations. Ensure that no liquid is spilled by covering the area with paper towels.

2. Clean the rinse stations using water and a brush (e.g. small commercial bottle brush). If available, place the rinse station inserts in an ultrasonic

bath (15 minutes, 25000 Hz, at 60 °C).

3. Ensure that all o-rings are seated correctly before returning the inserts to their original positions. Refit the clean rinse stations in the corresponding positions and screw in tight.

4. Switch the analyzer back on using the switch on the left side.

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10.510.5

10.5

10.510.5

Service MaintenanceService Maintenance

Service Maintenance

Service MaintenanceService Maintenance

Half-Yearly, Yearly, SpecialHalf-Yearly, Yearly, Special

Half-Yearly, Yearly, Special

Half-Yearly, Yearly, SpecialHalf-Yearly, Yearly, Special MaintenanceMaintenance

Maintenance

MaintenanceMaintenance

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FINAL 2.1 - February 2000 Chapter 10

2.6,1.5,0.5,6.3,1.3,4.2,4.1sgnibuT·

1-01e

Page 47

Elecsys 1010 Service Manual

Half- Yearly MaintenanceHalf- Yearly Maintenance

Half- Yearly Maintenance

Half- Yearly MaintenanceHalf- Yearly Maintenance

ProcedureProcedure

Procedure

ProcedureProcedure In order to clean and to disinfect the instrument,

SYSTEM CLEANING INTENSIVE as well as CELL CLEANING INTENSIVE should be activated prior to the replacement of parts: Switch the instrument on and activate “SYSTEM CLEANING INTENSIVE”. For part 1 of this cleaning program, fill the System Water Container with at least 2.5 L of 0.5% Edisonite Solution.

As soon as part 1 is finished, rinse the System Water Container with deionized water, fill it with deionized water, put it back to the instrument and activate part 2 of the cleaning program (Press the START button).

CELL CLEANING INTENSIVECELL CLEANING INTENSIVE

CELL CLEANING INTENSIVE

CELL CLEANING INTENSIVECELL CLEANING INTENSIVE Fill the System Water Container with deionized water,

empty the waste container. Put a ProCell container which is filled with 60 ml ISE Cleaning Solution on position 2 of the System, Reagent compartment. Activate the function CELL CLEANING INTENSIVE. Afterwards remove the S/R Rotor as well as Wash Station Inserts, “Cover Inside” (362), MFA Housing Insert”(366), “Instrument Housing Top” (360) and the “Front Panel”(369). Refer to chapter 4.1.1 of the Service Manual.

Final Checks and CalibrationsFinal Checks and Calibrations

Final Checks and Calibrations

Final Checks and CalibrationsFinal Checks and Calibrations Check mechanical adjustments as well as pump volume

adjustments (Service Software). Run a CELL CHECK and edit the existing “Kosigkal.csv”-file accordingly. All test assays are to be calibrated after the maintenance! Run at least 3 different test parameters and check the calibration results as well as the precision.

TubingsTubings

Tubings

TubingsTubings Replace the Waste Pump Tubings, the Pinch Tubings

and the S/R Tubing 1.5. Check the Waste Tubings (coming from the Wash Stations) and replace them in case of any visible contamination.

SyringesSyringes

Syringes

SyringesSyringes Replace the plungers of the S/R Syringe and the Sipper

Syringe.

AirfiltersAirfilters

Airfilters

AirfiltersAirfilters Replace the Airfilter Inserts.

Wash StationsWash Stations

Wash Stations

Wash StationsWash Stations Clean the Wash Station Inserts with water using a soft

brush. Check, if there are any particles inside the jets and remove them if necessary. Afterwards the O-rings of the Wash Station Inserts are to be replaced.

All parts required for the half-yearly maintenanceAll parts required for the half-yearly maintenance

All parts required for the half-yearly maintenance

All parts required for the half-yearly maintenanceAll parts required for the half-yearly maintenance are included in the “Maintenance Kit E 1010”are included in the “Maintenance Kit E 1010”

are included in the “Maintenance Kit E 1010”

are included in the “Maintenance Kit E 1010”are included in the “Maintenance Kit E 1010”

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Elecsys 1010 Service Manual

Yearly MaintenanceYearly Maintenance

Yearly Maintenance

Yearly MaintenanceYearly Maintenance

ProcedureProcedure

Procedure

ProcedureProcedure Follow the procedure “Half-Yearly Maintenance”. It is

recommended to replace the following parts in addition (to be ordered seperately).

Water Supply SystemWater Supply System

Water Supply System

Water Supply SystemWater Supply System Replace the Buffer Tank as well as the Water Filter

(called CT-wash filter).

CellCell

Cell

CellCell Replace the Cell incl. Reference Electrode, Cell Tubing

0.8, Tubing Sipper (1), Tubing Sipper (2), as well as the Restrictor Tubing (between VM1 and waste tubing). Even though the Cell is replaced completely, the CELL CLEANING INTENSIVE should be done before, because this measure will clean the Preheater as well (potential clots).

Important! It is essential that at least 30 “PrepareImportant! It is essential that at least 30 “Prepare

Important! It is essential that at least 30 “Prepare

Important! It is essential that at least 30 “PrepareImportant! It is essential that at least 30 “Prepare Cycles” are performed before the system isCycles” are performed before the system is

Cycles” are performed before the system is

Cycles” are performed before the system isCycles” are performed before the system is calibrated! Start the Service Software and activatecalibrated! Start the Service Software and activate

calibrated! Start the Service Software and activate

calibrated! Start the Service Software and activatecalibrated! Start the Service Software and activate the function “CELL INSTALL” in order to run the a.-the function “CELL INSTALL” in order to run the a.-

the function “CELL INSTALL” in order to run the a.-

the function “CELL INSTALL” in order to run the a.-the function “CELL INSTALL” in order to run the a.m. cycles. Since the volume of the Sipper Systemm. cycles. Since the volume of the Sipper System

m. cycles. Since the volume of the Sipper System

m. cycles. Since the volume of the Sipper Systemm. cycles. Since the volume of the Sipper System has changed after the replacement of the Cell andhas changed after the replacement of the Cell and

has changed after the replacement of the Cell and

has changed after the replacement of the Cell andhas changed after the replacement of the Cell and the Sipper Tubings, it is important that “SYSTEMthe Sipper Tubings, it is important that “SYSTEM

the Sipper Tubings, it is important that “SYSTEM

the Sipper Tubings, it is important that “SYSTEMthe Sipper Tubings, it is important that “SYSTEM VOLUME CHECK” is done before the instrument isVOLUME CHECK” is done before the instrument is

VOLUME CHECK” is done before the instrument is

VOLUME CHECK” is done before the instrument isVOLUME CHECK” is done before the instrument is used.used.

used.

used.used.

Final Checks and calibrationsFinal Checks and calibrations

Final Checks and calibrations

Final Checks and calibrationsFinal Checks and calibrations Check mechanical adjustments as well as pump volume

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Elecsys 1010 Service Manual

Service MaintenanceService Maintenance

Service Maintenance

Service MaintenanceService Maintenance

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This procedure must be used in case of potential bacterial contamination only!

This procedure must be used in case of potential bacterial contamination only!This procedure must be used in case of potential bacterial contamination only! Only RD FSRs are allowed to run this procedure!Only RD FSRs are allowed to run this procedure!

Only RD FSRs are allowed to run this procedure!

Only RD FSRs are allowed to run this procedure!Only RD FSRs are allowed to run this procedure!

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Elecsys 1010 Service Manual

Special MaintenanceSpecial Maintenance

Special Maintenance

Special MaintenanceSpecial Maintenance

ProcedureProcedure

Procedure

ProcedureProcedure All tubings which will be replaced during “Special

Maintenance” can be created of the “Tubing Set E1010”. Exceptions: Tubing S/R 1.5 and Tubing Dilutor S/R.

In order to clean and to disinfect the instrument, SYSTEM CLEANING INTENSIVE as well as CELL CLEANING INTENSIVE should be activated prior to the replacement of parts: Switch the instrument on and activate “SYSTEM CLEANING INTENSIVE”. For part 1 of this cleaning program, fill the System Water Container with at least 2.5 L of 0.5% Edisonite Solution.

As soon as part 1 is finished, rinse the System Water Container with deionized water, fill it withdeionized water, put it back to the instrument and activate part 2 of the cleaning program (Press the START button).

CELL CLEANING INTENSIVECELL CLEANING INTENSIVE

CELL CLEANING INTENSIVE

CELL CLEANING INTENSIVECELL CLEANING INTENSIVE Fill the System Water Container with deionized water,

empty the waste container. Put a ProCell container which is filled with 60 mL ISE Cleaning Solution on position 2 of the System Reagent compartement.

Activate the function CELL CLEANING INTENSIVE. Afterwards remove the S/R Rotor as well as Wash

Station Inserts, “Cover Inside” (362), MFA Housing Insert”(366), “Instrument Housing Top” (360) and the “Front Panel”(369). Refer to chapter 4.1.1 of the Service Manual.

After the reassemblyAfter the reassembly

After the reassembly

After the reassemblyAfter the reassembly Switch the instrument on and activate “SYSTEM

CLEANING INTENSIVE”. For part 1 of this cleaning program, fill the System Water Container with at least 2 L

3% Peroxide3% Peroxide

3% Peroxide Solution.

3% Peroxide3% Peroxide

Final Checks and calibrationsFinal Checks and calibrations

Final Checks and calibrations

Final Checks and calibrationsFinal Checks and calibrations Check mechanical adjustments as well as pump volume

adjustments (Service Software). Run a CELL CHECK and edit the existing “Kosigkal.csv”-file accordingly. All test assays are to be calibrated after the “Special Maintenance”! Run at least 3 different test parameters and check the calibration results as well as the precision.

Note:Note:

Note:

Note:Note:

If one of the cell cleaning programs (CELLIf one of the cell cleaning programs (CELL

If one of the cell cleaning programs (CELL

If one of the cell cleaning programs (CELLIf one of the cell cleaning programs (CELL CLEANING NORMAL or CELL CLEANINGCLEANING NORMAL or CELL CLEANING

CLEANING NORMAL or CELL CLEANING

CLEANING NORMAL or CELL CLEANINGCLEANING NORMAL or CELL CLEANING INTENSIVE) is interrupted, e.g. instrumentINTENSIVE) is interrupted, e.g. instrument

INTENSIVE) is interrupted, e.g. instrument

INTENSIVE) is interrupted, e.g. instrumentINTENSIVE) is interrupted, e.g. instrument cover opened, any fatalcover opened, any fatal

cover opened, any fatal

cover opened, any fatalcover opened, any fatal error, etc, a PRIME&RINSE has to beerror, etc, a PRIME&RINSE has to be

error, etc, a PRIME&RINSE has to be

error, etc, a PRIME&RINSE has to beerror, etc, a PRIME&RINSE has to be started immediately! (In order to removestarted immediately! (In order to remove

started immediately! (In order to remove

started immediately! (In order to removestarted immediately! (In order to remove the ISE Cleaning Solution).the ISE Cleaning Solution).

the ISE Cleaning Solution).

the ISE Cleaning Solution).the ISE Cleaning Solution).

Water Supply SystemWater Supply System

Water Supply System

Water Supply SystemWater Supply System Basically all tubings of the Water Supply System are to

be replaced (see table above). In addition the tubings “Tubing S/R 1.5” and “Tubing Dilutor S/R” should be replaced as well.

Buffer TankBuffer Tank

Buffer Tank

Buffer TankBuffer Tank Replace the Buffer Tank as well as the Water Filter

(called CT-wash filter).

Wash Station InsertsWash Station Inserts

Wash Station Inserts

Wash Station InsertsWash Station Inserts Clean the Wash Station Inserts with

solution using a soft brush. Check, if there are any particles inside the jets and remove them if necessary.

FINAL 2.1 - February 2000 Chapter 10

3% Peroxide3% Peroxide

3% Peroxide

3% Peroxide3% Peroxide

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Preparation of 0.5 % EDISONITE solutionPreparation of 0.5 % EDISONITE solution

Preparation of 0.5 % EDISONITE solution

Preparation of 0.5 % EDISONITE solutionPreparation of 0.5 % EDISONITE solution

Dissolve 10g of EDISONITE powder in 2 L of warm (25 C to 35 C) water . Either deionized (preferable) or tab water may be used. Fill the completely dissolved solution into an empty System Water Container and put it onto the anaylzer. Activate the function SYSTEM CLEANING INTENSIVE

HintHint

Hint

HintHint If no balance is available in the laboratory, you may use

a 50 mL measuring cylinder in order to determine the amount of EDISONITE powder: 10 g is equivalent to about 13mL of powder.

Contents of Maintenance Kit ELECSYS 1010 andContents of Maintenance Kit ELECSYS 1010 and

Contents of Maintenance Kit ELECSYS 1010 and

Contents of Maintenance Kit ELECSYS 1010 andContents of Maintenance Kit ELECSYS 1010 and Tubing Set ELECSYS 1010Tubing Set ELECSYS 1010

Tubing Set ELECSYS 1010

Tubing Set ELECSYS 1010Tubing Set ELECSYS 1010 The contents of the Maintenance Kit E 1010 and the

Tubing Set E 1010 are listed in the tables below:

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Maintenance Kit Elecsys 1010 RD Id.: 190 6941Maintenance Kit Elecsys 1010 RD Id.: 190 6941

Maintenance Kit Elecsys 1010 RD Id.: 190 6941

Maintenance Kit Elecsys 1010 RD Id.: 190 6941Maintenance Kit Elecsys 1010 RD Id.: 190 6941 001001

001

001001

Amount: Part:

1 Set Air Filter

1 Set Tubings Waste Pump

3 m Waste Tubing (Tygon)

1 Set Pinch Tubing (for VAD1)

1 Set O-rings (for Wash Station inserts)

1 Piston for Syringe 250 uL

1 Piston for Syringe 2500 uL

1 Tubing S/R 1.5

e10-3

Tubing Set Elecsys 1010 RD Id.: 190 6933 001Tubing Set Elecsys 1010 RD Id.: 190 6933 001

Tubing Set Elecsys 1010 RD Id.: 190 6933 001

Tubing Set Elecsys 1010 RD Id.: 190 6933 001Tubing Set Elecsys 1010 RD Id.: 190 6933 001

Amount: Part:

10 Fitting (grey)

6 Fitting (red)

5 Fitting (yellow)

6 Fitting (green)

6 Fitting (blue)

6 Fitting (black)

3 Fitting (white)

30 Adapter (nipples for wash stations)

5 Meter Tubing (inner diameter 1.5 mm)

3 Meter Tubing (inner diameter 2.0 mm)

4 Distributor (plastic) (Input Wash stations)

5 Distributor (plastic) (Y-shape)

7.5 Meter Waste Tubing (Tygon)

0.5 Meter Silicon Tubing (outer diameter 8mm , inner diameter 5mm)

0.5 Meter Silicon Tubing (outer diameter 7mm , inner diameter 4mm)

6 Nipple (for Buffer Tank)

e10-4

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10.6 Preventive Maintenance10.6 Preventive Maintenance

10.6 Preventive Maintenance

10.6 Preventive Maintenance10.6 Preventive Maintenance

The following parts should be replaced on a regular basis:

Partname Material No. 6 month 12 month 24 month Total

parts / year

SYRINGE SIPPER 1709828001 Yes 0,5

SYRINGE S/R 1709801001 Yes 0,5

TUBING SET 1801929001 Yes 1

TUBING SIPPER (2) 0.8 1802640001 Yes 1

TUBING SIPPER (1) 0.8 1802631001 Yes 1

TUBING WASTE 1801902001 Yes 0,5

TUBING S/R 1.5 1802666001 Yes 0,5

TUBING CELL 0.8 1802658001 Yes 1

SPARE PART KIT MC 1706683001 Yes 1

NEEDLE SIPPER 1709780001 Yes 0,5

NEEDLE S/R 1709798001 Yes 0,5

BEADMIXER 1709968001 Yes 0,5

MAINTENACE KIT 1802119001 Yes 2

10-2-1

The above-mentioned parts should be exchanged when the instrument is under service contract. The recommended regular maintenance interval is 6 months. A cell exchange needs to be done after 12 months.

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10.710.7

10.7

10.710.7

Necessary materials for operator maintenance which can be ordered from RD.

NameName

Name

NameName Edisonite

Edisonite® (1 kg) + measuring cup 1997203 SysClean (5 bottles à 100 mL) 1298500 SysClean adapter 1933159 Printer paper 1709615

Maintenance Materials Maintenance Materials

Maintenance Materials

Maintenance Materials Maintenance Materials

Material numberMaterial number

Material number

Material numberMaterial number

(1 kg) 1565524

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GlossaryGlossary

Glossary

GlossaryGlossary

AppendixAppendix

Appendix

AppendixAppendix

AB _____________ assay buffer AC _____________ A/D ____________ analogue to digital ADC ___________ analogue to digital converter AE _____________ working electrode

B ______________ beads BCR ___________ barcode reader BIOS ___________ basic input output system BP _____________ base print BP1 ____________ detection module BP2 ____________ sample/reagent dilutor BP3 ____________ temp control module BP4 ____________ sample/reagent rotor and

incubator rotor BP5 ____________ dilutor reagent BP6 ____________ incubator heater BP7 ____________ clot detection module

CAN ___________ controller area network CE _____________ CPU ___________ central processing unit CS _____________ cleaning solution

D ______________ aspiration into the measuring cell

and optical detection D/A ____________ digital to analogue DC _____________ DD _____________ DL _____________ diluted sample/calibrator/check DIN ____________ Deutsche Industrie Norm DOS TUS _______ DOS test and control software DRAM __________ dynamic random access memory

ECL ____________ electrochemical luminescence EMC/EMB _______ EPROM _________ electrical programmable read

only memory

PROM ________ electrical erasable and

programmable read only memory

F ______________ fatal error FD _____________ floppy disk

gnd ____________ ground

HS _____________

I _______________ information i _______________ incubation time IBM/AT _________ ID _____________ identification I D E ___________ IRS ____________ I-CAL ___________

KUST __________ communication and control

software

K3FLA14A_______ normal sequence for measuring

heterogenous bead suspensions

K3CHE14A ______ special sequence for measuring

homogenous solutions

LC display _______ liquid crystal display LLD ____________ liquid level detection LED ____________ light emitting diode LSM____________ laboratory system manager

MBC ___________ two dimensional barcode MFA____________ multifunctional arm

NTC____________ negative temperature coefficient

OEM ___________ original equipment manufacture ORIGEN® _______ new measuring technology

PSD____________ PMT____________ photomultiplier tube PSID ___________ positive user identification PC _____________ personal computer PhC ____________ photocoupler PS _____________ prereaction solution POP____________ PCB____________ printed circuit board PWS ___________ PWD ___________

RA _____________ return authorization RAM ___________ random access memory RE _____________ reference electrode ROM ___________ read only memory RS232 __________ serial interface RackPack _______ special reagent bottle

combination R0 _____________ diluent RM_____________ pretreatment solution R1 _____________ reagent 1 (assay RackPack)

FINAL 2.1 - February 2000 Appendix

Page 1

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R2 _____________ reagent 2 (assay RackPack)

S ______________ undiluted sample/calibrator/check S/R ____________ sample/reagent STAT___________ short-turn-around-time SP _____________ SW on __________ software on SyMu ___________ SM_____________ SRAM __________ static random access memory SW ____________ software SD _____________ SBC____________

TTL ____________

VAD1___________ VDD ___________ VGA____________ video graphics array VAB1 ___________ VAD2___________ VDC ___________ direct current voltage VWD1 __________ VWD2 __________ VWB1 __________ VSD____________ VM1____________ VWS1 __________ VAS1 ___________ VDE____________

WA ____________ WE ____________ WB1 ___________ WD2 ___________ WD1 ___________ WS1 ___________ W______________ warning

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Page 2

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InstallationInstallation

Installation

InstallationInstallation

2.12.1

2.1

2.12.1

2.22.2

2.2

2.22.2

2.32.3

2.3

2.32.3

2.42.4

2.4

2.42.4

2.52.5

2.5

2.52.5

Site RequirementsSite Requirements

Site Requirements

Site RequirementsSite Requirements InventoryInventory

Inventory

InventoryInventory

2.2.12.2.1

2.2.1

2.2.12.2.1

External Computer InstallationExternal Computer Installation

External Computer Installation

External Computer InstallationExternal Computer Installation Software InstallationSoftware Installation

Software Installation

Software InstallationSoftware Installation Analyzer InstallationAnalyzer Installation

Analyzer Installation

Analyzer InstallationAnalyzer Installation

2.5.12.5.1

2.5.1

2.5.12.5.1

2.5.22.5.2

2.5.2

2.5.22.5.2

2.5.32.5.3

2.5.3

2.5.32.5.3

2.5.42.5.4

2.5.4

2.5.42.5.4

2.5.52.5.5

2.5.5

2.5.52.5.5

LocationLocation

Location

LocationLocation

Initial InstallationInitial Installation

Initial Installation

Initial InstallationInitial Installation Setup with preinstalled cellSetup with preinstalled cell

Setup with preinstalled cell

Setup with preinstalled cellSetup with preinstalled cell General InformationGeneral Information

General Information

General InformationGeneral Information Cell ExchangeCell Exchange

Cell Exchange

Cell ExchangeCell Exchange Cell installationCell installation

Cell installation

Cell installationCell installation

__________________________________________________________________________________

_________________________________________

__________________________________________________________________________________

________________________________________________________________________________________________

________________________________________________

________________________________________________________________________________________________

__________________________________________________________________________________________________________________________

_____________________________________________________________

__________________________________________________________________________________________________________________________

____________________________________________________________

______________________________

____________________________________________________________

____________________________________________________________________________

______________________________________

____________________________________________________________________________ ____________________________________________________________________________

______________________________________

____________________________________________________________________________

__________________________________________________________________________________________________________

_____________________________________________________

__________________________________________________________________________________________________________

________________________________________________________________________________________

____________________________________________

________________________________________________________________________________________

____________________________________________________________________________________________________

__________________________________________________

____________________________________________________________________________________________________

______________________________________________________________________________________________________________

_______________________________________________________

______________________________________________________________________________________________________________

____________________________________________________________________________________________________________

______________________________________________________

____________________________________________________________________________________________________________

1111

1111 1313

1313

1313 1414

1414 1515

1515 1616

1616 1717

1717

11 33

2.62.6

2.6

2.62.6

2.72.7

2.7

2.72.7

2.5.5.12.5.5.1

2.5.5.1

2.5.5.12.5.5.1

2.5.62.5.6

2.5.6

2.5.62.5.6

Transport Preparation (Decontamination of the Cell)Transport Preparation (Decontamination of the Cell)

Transport Preparation (Decontamination of the Cell)

Transport Preparation (Decontamination of the Cell)Transport Preparation (Decontamination of the Cell) DE-Installation and Shipping ProcedureDE-Installation and Shipping Procedure

DE-Installation and Shipping Procedure

DE-Installation and Shipping ProcedureDE-Installation and Shipping Procedure

Cell Installation Flow ChartCell Installation Flow Chart

Cell Installation Flow Chart

Cell Installation Flow ChartCell Installation Flow Chart Installation Checklist Elecsys 1010Installation Checklist Elecsys 1010

Installation Checklist Elecsys 1010

Installation Checklist Elecsys 1010Installation Checklist Elecsys 1010

________________________________________________________________________________________

____________________________________________

________________________________________________________________________________________

____________________________________________________________________________

______________________________________

____________________________________________________________________________

____________________________________________

______________________

____________________________________________

______________________

___________

______________________

1818

1818 1919

1919

2121

2121 2323

2323

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Ventilation and Air Conditioning RequirementsVentilation and Air Conditioning Requirements

Ventilation and Air Conditioning Requirements

2.12.1

2.1

2.12.1

PackagingPackaging

Packaging

PackagingPackaging Packaging dimensions of Elecsys 1010: Length: 120 cm

Height: 100 cm Depth: 100 cm Total weight: approx. 156 kg incl. package

Transport to the Installation SiteTransport to the Installation Site

Transport to the Installation Site

Transport to the Installation SiteTransport to the Installation Site Prerequisites for a safe transport of the instrument to the installation site after unpacking:

- Minimum door width: 80 cm

- Minimum turning circle: 100 cm Note:Note:

Note:

Note:Note: The customer may take his/her own special precautions for unpacking or transport to the site.

Space Requirements at the SiteSpace Requirements at the Site

Space Requirements at the Site

Space Requirements at the SiteSpace Requirements at the Site

InstallationInstallation

Installation

InstallationInstallation

Site RequirementsSite Requirements

Site Requirements

Site RequirementsSite Requirements

Ventilation and Air Conditioning RequirementsVentilation and Air Conditioning Requirements

- A tenfold air exchange per hour is required near the

instrument

. The instrument must not be in a direct draft from above

or from the side.

Air ConditioningAir Conditioning

Air Conditioning

Air ConditioningAir Conditioning An ambient temperature of 18° to 32° C (60° to 95° F) is

required for faultless operation. Avoid direct exposure to heat (sunlight). The temperature must not vary by more than ± 3° C. Relative air humidity 45-85%, without condensation.

Electric ConnectionElectric Connection

Electric Connection

Electric ConnectionElectric Connection Conditions for electric connection:

Self-adjusting mains connection with an input voltage of 80 to 250 VAC, 800 VA, 50 to 60 Hz.

The 80/250 VAC connection must meet the following requirements:

- 3-lead single phase wiring, grounded, grounding < 10

ohm.

- Rated for a minimum of 10 A (220/240 V) and/or 20 A

(100/115 V), termination by power outlet.

The Analyser weighs approximately 120 kg. Weight is distributed on four (4) levelling feet, 1/2" diameter.

Dimensions of the instrument: Width: 96 cm Height:62 cm Depth: 78 cm Minimum distance to front and back: 30 cm.

Water Quality RequirementsWater Quality Requirements

Water Quality Requirements

Water Quality RequirementsWater Quality Requirements Deionized (or distilled) water is normally used.

Specification of the water treatment plant:

- Required water quality: deionized or distilled water with a resistance of 1.5 megohm or greater (conductivity below 1 µ Siemens).

Reagent StorageReagent Storage

Reagent Storage

Reagent StorageReagent Storage Store the test reagents in a cool place at a temperature of

2 - 9° C. Assay buffer and cell cleaner do not have to be stored in a cool place.

Roche Diagnostics recommends to keep a reagent stock for sixty (60) days. This quantity should be sufficient to compensate for any supply delays. The stock keeping requirements depend mainly on the system configuration and the instrument volume.

Variations of the above specifications need to be examined and approved by the technical service.

Faultless operation of the Roche Diagnostics instrument can only be guaranteed in accordance with the above specifications. The CUSTOMER acknowledged by signature that operation of the Elecsys 1010 in different conditions without prior consent by the technical service may void the warranty.

Connect Elecsys 1010 only by using one of the enclosed (RD) power cables.

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2.22.2

2.2

2.22.2

Instrument incl. accessories 1

Instrument 1 *

dest. water bottle, complete 1

BOTTLE WASTE 1 * supplied with the instrument

Sipper needle 1

S/R needle 1

Power cable US 1

Power cable GERMAN 1

3 x 4 Assay Cup Set 1

Cell + Ref. el. 1

SYRINGE S/R 1

SYRINGE SIPPER 1

InventoryInventory

Inventory

InventoryInventory

Designation Quantity Conf. Remarks

Software Operator 1

Ref. data disk 1

Printer paper 1

Packaging accessories 1

Packaging instrument 1

Packing list 1

Parameter disk 1 * supplied with the instrument

Beadmixer 1

Cup Twist 2

Secundarcupadapter 6

Sample Cup

Bottle Valve 1

Certificate 1 *

Operator Manuals

Operator Manual German to be ordered separately

Operator Manual English to be ordered separately

e-Tab7

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2.2.12.2.1

2.2.1

2.2.12.2.1

E-22

Fig.: Instrument incl. accessories

LocationLocation

Location

LocationLocation

E-10

Fig.: Sipper needle

E-23

Fig.: Instrument

E-2

Fig.: Dist. water bottle, complete

E-4

Fig.: S/R needle

E-6

Fig.: Power cable US

E-3 E-5

Fig.: Bottle waste

Fig.: Power cable GERMAN

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E-14

Fig.: 3 x 4 Assay Cup Set

E-17

Fig.: Cell + ref. el.

E-11

Fig.: Operator software

E-12

Fig.: Ref. data disk

E-9

Fig.: SYRINGE S/R

E-8 E-20

Fig.: SYRINGE SIPPER

Fig.: Printer paper

Fig.: Packaging accessories

FINAL 2.1 - February 2000 Chapter 2Page 5

E-1

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E-24

Fig.: Packaging instrument

E-21

Fig.: Packing list

E-7

Fig.: Cap twist

E-13

Fig.: Secondary cupadapter

E-19 E-16

Fig.: Parameter disk Fig.: Sample cup

I00 E-15

Fig.: Bead mixer

Fig.: Bottle valve

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E-18

Fig.: Certificate

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2.32.3

2.3

2.32.3

The Elecsys 1010 has a RS232 interface for the connection of an external computer. The Laboratory System Manager (LSM) is also connected to this interface. The communication protocol is based on the ASTM standard. Instrument data can be transmitted by the same interface via modem (Remote Access). On the interface supporting plates, there is an additional Centronics interface connector for an external printer.

External Computer InstallationExternal Computer Installation

External Computer Installation

External Computer InstallationExternal Computer Installation

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2.42.4

2.4

2.42.4

The operation software is delivered on 1 disk coming with the instruments.

The disk is labeled with:

- User Software Elecsys 1010 Version XX

The software is preinstalled on the flash ROM of the OEM master. In case a software update need to be reloaded, please follow the given instructions:

1. Insert the disk in the disk drive and switch on the

2. The software will be installed automatically

Note:Note:

Note:

Note:Note: All software versions will contain the operating software

and the corresponding module software. When updating the operating software all changes of the module software versions will be updated at the same time. The module software can be downloaded individualy using the DOS TUS software. When updating the operating software special care has to be taken to update the module software at the same time.

Software InstallationSoftware Installation

Software Installation

Software InstallationSoftware Installation

instrument.

Follow the instructions given on the screen. A complete installation will take appr. 10 min.

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2.52.5

2.5

2.52.5

2.5.12.5.1

2.5.1

2.5.12.5.1

Analyzer InstallationAnalyzer Installation

Analyzer Installation

Analyzer InstallationAnalyzer Installation

Initial InstallationInitial Installation

Initial Installation

Initial InstallationInitial Installation

TaskTask

Task

TaskTask

UnpackingUnpacking

Unpacking

UnpackingUnpacking

Assembling the ProbesAssembling the Probes

Assembling the Probes

Assembling the ProbesAssembling the Probes

Assembling the Cell and Reference ElectrodeAssembling the Cell and Reference Electrode

Assembling the Cell and Reference Electrode

Assembling the Cell and Reference ElectrodeAssembling the Cell and Reference Electrode

Software Installation (if required) see 2.4Software Installation (if required) see 2.4

Software Installation (if required) see 2.4

Software Installation (if required) see 2.4Software Installation (if required) see 2.4

2 x Prime + Rinse2 x Prime + Rinse

2 x Prime + Rinse

2 x Prime + Rinse2 x Prime + Rinse

______________________________________________________________

_______________________________

______________________________________________________________

__________________________________________

_____________________

__________________________________________

______

___

______

____________________________________________________

__________________________

____________________________________________________

DurationDuration

Duration

DurationDuration

20 min.20 min.

20 min.

20 min.20 min.

10 min.10 min.

10 min.

10 min.10 min.

30 min.30 min.

30 min.

30 min.30 min.

15 min.15 min.

15 min.

15 min.15 min.

Cell Install (Service Software)Cell Install (Service Software)

Cell Install (Service Software)

Cell Install (Service Software)Cell Install (Service Software)

Instrument Setup + Interface setupInstrument Setup + Interface setup

Instrument Setup + Interface setup

Instrument Setup + Interface setupInstrument Setup + Interface setup

Load Reference Data Disk, Set InventoryLoad Reference Data Disk, Set Inventory

Load Reference Data Disk, Set Inventory

Load Reference Data Disk, Set InventoryLoad Reference Data Disk, Set Inventory Perform Systemvolume check andPerform Systemvolume check and

Perform Systemvolume check and

Perform Systemvolume check andPerform Systemvolume check and Signallevel CalibrationSignallevel Calibration

Signallevel Calibration

Signallevel CalibrationSignallevel Calibration

Place Reagents, Calibration and ControlsPlace Reagents, Calibration and Controls

Place Reagents, Calibration and Controls

Place Reagents, Calibration and ControlsPlace Reagents, Calibration and Controls

TSH 10 SamplesTSH 10 Samples

TSH 10 Samples

TSH 10 SamplesTSH 10 Samples

Service ReportService Report

Service Report

Service ReportService Report

Overall Duration:Overall Duration:

Overall Duration:

Overall Duration:Overall Duration:

______________________________________________________

___________________________

______________________________________________________

__________________________________________________________

_____________________________

__________________________________________________________

________________________________

________________

________________________________

________________________

____________

________________________

______________

_______

______________

____________

______

____________

195 min.195 min.

195 min.

195 min.195 min.

30 min.30 min.

30 min.

30 min.30 min.

10 min.10 min.

10 min.

10 min.10 min.

30 min.30 min.

30 min.

30 min.30 min.

10 min.10 min.

10 min.

10 min.10 min.

30 min.30 min.

30 min.

30 min.30 min.

10 min.10 min.

10 min.

10 min.10 min.

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2.5.22.5.2

2.5.2

2.5.22.5.2

Setup with preinstalled cellSetup with preinstalled cell

Setup with preinstalled cell

Setup with preinstalled cellSetup with preinstalled cell

TaskTask

Task

TaskTask

UnpackingUnpacking

Unpacking

UnpackingUnpacking

Assembling the NeedlesAssembling the Needles

Assembling the Needles

Assembling the NeedlesAssembling the Needles

Prime + RinsePrime + Rinse

Prime + Rinse

Prime + RinsePrime + Rinse

Instrument Setup + Interface setupInstrument Setup + Interface setup

Instrument Setup + Interface setup

Instrument Setup + Interface setupInstrument Setup + Interface setup

______________________________________________________________

_______________________________

______________________________________________________________

__________________________________________________________

_____________________________

__________________________________________________________

________________________________________

____________________

________________________________________

________________________

____________

________________________

DurationDuration

Duration

DurationDuration

20 min.20 min.

20 min.

20 min.20 min.

10 min.10 min.

10 min.

10 min.10 min.

15 min.15 min.

15 min.

15 min.15 min.

10 min.10 min.

10 min.

10 min.10 min.

Load Reference Data Disk, Set InventoryLoad Reference Data Disk, Set Inventory

Load Reference Data Disk, Set Inventory

Load Reference Data Disk, Set InventoryLoad Reference Data Disk, Set Inventory Perform Systemvolume check andPerform Systemvolume check and

Perform Systemvolume check and

Perform Systemvolume check andPerform Systemvolume check and Signallevel CalibrationSignallevel Calibration

Signallevel Calibration

Signallevel CalibrationSignallevel Calibration

Place Reagents, Calibration and ControlsPlace Reagents, Calibration and Controls

Place Reagents, Calibration and Controls

Place Reagents, Calibration and ControlsPlace Reagents, Calibration and Controls

TSH 10 SamplesTSH 10 Samples

TSH 10 Samples

TSH 10 SamplesTSH 10 Samples

Service ReportService Report

Service Report

Service ReportService Report

Overall Duration:Overall Duration:

Overall Duration:

Overall Duration:Overall Duration:

______________________________________________________

___________________________

______________________________________________________

__________________________________________________________

_____________________________

__________________________________________________________

______________

_______

______________

____________

______

____________

30 min.30 min.

30 min.

30 min.30 min.

10 min.10 min.

10 min.

10 min.10 min.

30 min.30 min.

30 min.

30 min.30 min.

10 min.10 min.

10 min.

10 min.10 min.

135 min.135 min.

135 min.

135 min.135 min.

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2.5.32.5.3

2.5.3

2.5.32.5.3

Prior to starting the initial installation procedure, check the supplied components against the packing list for completeness. Keep the original packing material of the instrument as it may be reused for future transports.

Protection against EarthquakesProtection against Earthquakes

Protection against Earthquakes

Protection against EarthquakesProtection against Earthquakes To protect Elecsys 1010 in with seismic activities (e.g.

California), remove two instrument feet and fix the instrument base to the table top by means of screws from below.

Removing the Securing DevicesRemoving the Securing Devices

Removing the Securing Devices

Removing the Securing DevicesRemoving the Securing Devices Prior to removing the securing devices, set up the instru-

ment at the final installation site. The securing devices should not be removed earlier.

Voltage SettingVoltage Setting

Voltage Setting

Voltage SettingVoltage Setting No voltage setting is required as the instrument is equipped

with a wide-range voltage input.

General InformationGeneral Information

General Information

General InformationGeneral Information

Connection to MainsConnection to Mains

Connection to Mains

Connection to MainsConnection to Mains The instrument is connected to mains power by means of the

power cord provided. The power cord is connected on the left hand side of Elecsys 1010.

Note: In the USA the UL Power cord supplied with the analyzer should be used.

Printer PaperPrinter Paper

Printer Paper

Printer PaperPrinter Paper To access the printer, open the printer cover and insert the

paper real. Once the paper real is in place, insert the paper in the printer.

Bar Code LabelsBar Code Labels

Bar Code Labels

Bar Code LabelsBar Code Labels Fix the bar code labels to the primary sample tubes.

Assay Cup (Incubator)Assay Cup (Incubator)

Assay Cup (Incubator)

Assay Cup (Incubator)Assay Cup (Incubator) Up to 4 segments are placed in the incubator rotor. Ensure the

pin on the underside of the segments is properly inserted in the holes provided in the incubator rotor.

FINAL 2.1 - February 2000 Chapter 2Page 15

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2.5.42.5.4

2.5.4

2.5.42.5.4

The cell and reference electrode need to be exchanged at the same time. The exchange interval is normally after 1 year or 100,000 tests. This period is monitored by the counter in the maintenance log of the operation software.

Prior to the disassembly, the cell needs to be decontaminated. This is carried out with the service software by starting the „Cell Exchange" procedure. When the CleanCell is drawn into the cell it needs to remain inside for a minimum of 20 minutes. During this period routine maintenance work can be performed. After the decontamination procedure, part 2 of the cell exchange procedure can be started consisting of first priming the cell with ProCell followed by air. Then the cell may be removed from the instrument.

For more information refer to chapters 2.5.5 and 2.5.5.1

Cell ExchangeCell Exchange

Cell Exchange

Cell ExchangeCell Exchange

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2.5.52.5.5

2.5.5

2.5.52.5.5

Prior to the cell installation it is recommended to prime the tubings from the sipper syringe to the sipper probe with DIwater to remove any ProCell crystallization.

Perform the following actions:

1. Remove the cover inside in front of the detection unit

2. Open the housing of the detection unit.

3. Remove the PMT.

4. Check whether the joint mounted between the in and out

5. Mount the tubing on the preheater and the sipper probe (this

6. Remove the tubing on the top left side of the sipper syringe.

7. Flush DI-water through this tubing manually using a

8. Mount the tubing to the sipper syringe again. Same for the

9. Check the guide pins of the cell for proper placement. If

10. Mount the reference electrode to the cell.

11. Fix the cell cables around the reference electrode using a

12. Mount the cell.

13. Connect the cell to the PCB Potentiostat and the cable to

14. Mount the PMT and reconnect the cables to BP1.

15. Close the cover of the detection unit.

Cell installationCell installation

Cell installation

Cell installationCell installation

with the two screws on top of the instrument housing.

- Care should be taken by not dropping the two

lower screws into the instrument.

- Special care should be taken when disconnecting

the high voltage connector from the PCB BP1 in the back and the PMT signal connector in the front of BP1. The connectors on the BP1 are SMD

connectors!! tubing of the cell is correctly mounted and does not leak. tubing is located in the accessory box).

- Make sure that both fittings are tight!!

syringe while holding the sipper probe into the waste bottle (repeat several times).

sipper probe to the MFA. necessary fix these guide pins in the holes using super

glue.

cable tie.

the reference electrode.

FINAL 2.1 - February 2000 Chapter 2Page 17

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2.5.5.12.5.5.1

2.5.5.1

2.5.5.12.5.5.1

The most important actions of the cell installation are summarized in the flow chart below:

Cell Installation Flow ChartCell Installation Flow Chart

Cell Installation Flow Chart

Cell Installation Flow ChartCell Installation Flow Chart

Rinse sipper flow path with DI water

Install Cell and Reference Electrode

Switch the instrument on

- Check the Software version

- Setup water, ProCell and CleanCell

- Reset inventory screen

- Install reference data disk

Start the function PRIME and RINSE at least 2 times

Boot Service Software version Start "Cell Install" procedure (takes app. 30min.)

Start User Software Run "System Volume Check"

Check the flanges of the cell inlet and outlet tubing (adapter)

More than two measurements are not successful

Run "Cell Check" (Signal Level Calibration)

Edit "KOSIGKAL.CSV" on Drive D:\

Start eg. TSH Run

- Check calibration

- Check precision

FINAL 2.1 - February 2000 Chapter 2Page 18

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2.5.62.5.6

2.5.6

2.5.62.5.6

1. Locate and remove the following reagents from

2. Unpack Analyzer.

3. Inventory accessories shipped with analyzer.

4. Install the Measuring Cell.

5. Check

6. Verify that all circuit boards are fully pushed home.

7. Install Probes, Syringes and Mixer.

8. Check and replace as necessary DI WATER,

9. Close the cover; power UP analyzer and allow to

10.Verify software version, and perform a software

11.If necessary, read in the current revision of

12.Perform two ”PRIME & RINSE” cycles. (Util-

13.Insert Service Software Disk into Floppy Drive and

14.Select Service Software by pressing 1 on the

15.Perform a ”CELL INSTALL” function. (Check-

16.Remove Service Software Disk from Floppy Drive,

17.When Analyzer reaches STANDBY, perform a

18.Insert Service Software Disk into Floppy Drive and

19.Select Service Software by pressing 1 on the

20.Use service software to read High Voltage value

Installation Checklist Elecsys 1010Installation Checklist Elecsys 1010

Installation Checklist Elecsys 1010

Installation Checklist Elecsys 1010Installation Checklist Elecsys 1010

the refrigerator if necessary: TSH (1 rack pack), TSH Calibrator Set, PROCELL (2 bottles), CleanCell (2 bottles), BLANK CELL (1 rack pack).

(Refer to Service Manual Chap. 2.2). Verify Software Installation and Reference Data disks are the current version.

ALLALL

ALL tubing connections for a tight fit.

ALLALL

(These can work loose in shipping.)

(These can work loose in shipping).

PROCELL, CleanCell and ASSY CUPS.

enter ”STANDBY”.

installation if necessary (refer to TSB 778 for software installation procedure.

REFERENCE DATA disk.

Maintenance- Service).

power Analyzer OFF then ON.

keypad.

Detector/Cell- Cell Install). Observe the liquid flow through VM1 for any air leaks. Correct any leaks and perform CELL INSTALL again if necessary.

then power Analyzer OFF then ON.

”SYSTEM VOLUME CHECK”. Verify that the volume is within the specified limits. (UtilMaintenance- Service). Note:Note:

Note: If more that two consecutive SYSTEM

Note:Note: VOLUME CHECKS are unsuccessful, check all tubing connections and perform a CELL INSTALL function under the Service Software before repeating the SYSTEM VOLUME CHECK. This will recondition the measuring cell electrodes.

power Analyzer OFF then ON.

keypad.

from BSP 1 board. Write HV value on a sticky label and attach to the PMT assy. Reinstall the PMT cover.

21.Use service software to check and align, if necessary, all mechanisms and perform PUMP VOLUME adjustments.

22.Perform COMPUTE and then STORE. At the ”Please insert parameter disk” prompt, press any key to save the parameter to your service software disk.

23.Repeat Step 22, substituting the customer parameter disk at the ”Please insert parameter disk” prompt to save the parameters to customer parameter disk.

24.Remove Service Software Disk. Power analyzer Off then ON.

25.Perform two ”PRIME & RINSE” cycles. (UtilMaintenance- Service)

26.Perform a ”CELL CHECK” (Util- MaintenanceService). Verify that there are no bubbles in the Sipper flow path. If the results are within allowed ranges, edit them into the KOSIGKAL.CSV file refer to TSB 778).

CELL CHECK ranges are: OFFSET -212 to +108 FACTOR 0.020 to 0.030

NOTE:NOTE:

NOTE:To check the contents of the

NOTE:NOTE:

KOSIGKAL.CSV file after editing:

a) Go to DOS (Option 3 in Service Software boot

menu);

b) Type ”D:” and press the Enter key to go to the

D Drive;

c) Type ”TYPE_KOSIGKAL.CSV” [ENTER] ç

yes, you type the word ”type”, with a space between it and ”KOSIGKAL.CSV”. This causes the contents of KOSIGKAL to be displayed on the screen. Verify that this data is correct.

27.Calibrate, then run controls and a 10 cup precision pool on at least one assay. (Preferred assay is TSH).

28.Record the following information and leave with the Analyzer

Fig.: 2-5-6.tif

FINAL 2.1 - February 2000 Chapter 2Page 19

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FINAL 2.1 - February 2000 Chapter 2Page 20

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2.62.6

2.6

2.62.6

Transport PreparationTransport Preparation

Transport Preparation

Transport PreparationTransport Preparation (Decontamination of the Cell)(Decontamination of the Cell)

(Decontamination of the Cell)

(Decontamination of the Cell)(Decontamination of the Cell)

TaskTask

Task

TaskTask

Operation SoftwareOperation Software

Operation Software

Operation SoftwareOperation Software

CleaningCleaning

Cleaning

CleaningCleaning

Service SoftwareService Software

Service Software

Service SoftwareService Software

Cell ExchangeCell Exchange

Cell Exchange

Cell ExchangeCell Exchange Transport PreparationTransport Preparation

Transport Preparation

Transport PreparationTransport Preparation

DurationDuration

Duration

DurationDuration

20 min.20 min.

20 min.

20 min.20 min.

20 min.

20 min.20 min. 10 min.10 min.

10 min.

10 min.10 min.

Remove the NeedlesRemove the Needles

Remove the Needles

Remove the NeedlesRemove the Needles

Rinse the Water BottleRinse the Water Bottle

Rinse the Water Bottle

Rinse the Water BottleRinse the Water Bottle

RepackingRepacking

Repacking

RepackingRepacking

Overall Duration:Overall Duration:

Overall Duration:

Overall Duration:Overall Duration:

Note: Prior to any service intervention, the decontamination proce-

dure should be followed.

10 min.10 min.

10 min.

10 min.10 min.

10 min.

10 min.10 min.

20 min.20 min.

20 min.

20 min.20 min.

90 min.90 min.

90 min.

90 min.90 min.

FINAL 2.1 - February 2000 Chapter 2Page 21

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FINAL 2.1 - February 2000 Chapter 2Page 22

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Elecsys 1010 Service Manual

2.72.7

2.7

2.72.7

Note: Before shipping the analyzer should be decontaminated using the ELECSYS 1010 decontamination procedure.

1. Empty DI water bottle and place back on the system.

2. Go to Utilities / Maintenance / Service and select the

3. Remove top front cover to gain access to measuring

4. Remove black front cover from the measuring chamber to

5. Remove the PMT assy from its mount in the measurement

6. Remove the measurement cell.

7. Join the two measurement cell tubes together with a

8. Remove both probes and the mixer. These should be

9. Remove both the syringes and pack separately.

10. Place shaped protective foam sheet over the top of the S/

11. Place white foam panel over the shaped foam sheet and

12. Secure the keyboard assy with tape.

13. Place the analyzer in the shipping crate as shown in the

DE-Installation and ShippingDE-Installation and Shipping

DE-Installation and Shipping

DE-Installation and ShippingDE-Installation and Shipping ProcedureProcedure

Procedure

ProcedureProcedure

PURGE option. Repeat the PURGE option again. This will remove all DI water from the system. When finished empty the WASTE bottle and place it back in the system.

chamber. gain access to the PMT assy. chamber taking note of the Ribbon cable connections to the

circuit board and place the black plastic light shield over the entrance window. (The light shield can be found attached to the inside of the measurement assy black front cover removed in step #4).

female joint fitting. packed separately.

R disc / Incubation disc area and gently push the probe heads into the cutouts in the foam.

close the instrument lid. Use tape to secure the instruments lid to the instrument base during transport.

attached diagram and tape the crate shut.

FINAL 2.1 - February 2000 Chapter 2Page 23

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FINAL 2.1 - February 2000 Chapter 2Page 24

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Elecsys 1010 Service Manual

FluidicsFluidics

Fluidics

FluidicsFluidics

3.13.1

3.1

3.13.1

Fluidics OverviewFluidics Overview

Fluidics Overview

Fluidics OverviewFluidics Overview

3.1.13.1.1

3.1.1

3.1.13.1.1

3.1.23.1.2

3.1.2

3.1.23.1.2

3.1.33.1.3

3.1.3

3.1.33.1.3

3.1.43.1.4

3.1.4

3.1.43.1.4

3.1.53.1.5

3.1.5

3.1.53.1.5

3.1.63.1.6

3.1.6

3.1.63.1.6

.2.2

TubingsTubings

Tubings

.2.2

TubingsTubings

3.2.13.2.1

3.2.1

3.2.13.2.1

____________________________________________________________________________________

__________________________________________

____________________________________________________________________________________

LegendLegend

Legend

LegendLegend General Fluidics DrawingGeneral Fluidics Drawing

General Fluidics Drawing

General Fluidics DrawingGeneral Fluidics Drawing Feeding Pipes to Wash StationsFeeding Pipes to Wash Stations

Feeding Pipes to Wash Stations

Feeding Pipes to Wash StationsFeeding Pipes to Wash Stations WD 1, WD 2, WB 1WD 1, WD 2, WB 1

WD 1, WD 2, WB 1

WD 1, WD 2, WB 1WD 1, WD 2, WB 1 Fluid StationFluid Station

Fluid Station

Fluid StationFluid Station Water Supply SystemWater Supply System

Water Supply System

Water Supply SystemWater Supply System Waste Tubings, Pump,Waste Tubings, Pump,

Waste Tubings, Pump,

Waste Tubings, Pump,Waste Tubings, Pump, Distributor, Tubing to Wash Station WS 1Distributor, Tubing to Wash Station WS 1

Distributor, Tubing to Wash Station WS 1

Distributor, Tubing to Wash Station WS 1Distributor, Tubing to Wash Station WS 1

Legend for Fluidics OverviewLegend for Fluidics Overview

Legend for Fluidics Overview

Legend for Fluidics OverviewLegend for Fluidics Overview

3.2.1.13.2.1.1

3.2.1.1

3.2.1.13.2.1.1

______________________________________________________________________________________________________________

_______________________________________________________

______________________________________________________________________________________________________________

________________________________________________________________________________

________________________________________

________________________________________________________________________________

____________________________________________________________________________________________

______________________________________________

____________________________________________________________________________________________

______________________________________________________________________________________________________

___________________________________________________

______________________________________________________________________________________________________

________________________________________________________________________________________

____________________________________________

________________________________________________________________________________________

______________________________________________________________________________________________

_______________________________________________

______________________________________________________________________________________________

__________________________________________________________________________

_____________________________________

__________________________________________________________________________

Tubing System Water 1Tubing System Water 1

Tubing System Water 1

Tubing System Water 1Tubing System Water 1

______________________________________________________________________________________

___________________________________________

______________________________________________________________________________________

______________________________________________________

___________________________

______________________________________________________

22 33

55 66

66 77

3.2.23.2.2

3.2.2

3.2.23.2.2

3.2.33.2.3

3.2.3

3.2.33.2.3

3.2.43.2.4

3.2.4

3.2.43.2.4

3.2.1.23.2.1.2

3.2.1.2

3.2.1.23.2.1.2

3.2.1.33.2.1.3

3.2.1.3

3.2.1.33.2.1.3

3.2.1.43.2.1.4

3.2.1.4

3.2.1.43.2.1.4

ConnectionsConnections

Connections

ConnectionsConnections LocationLocation

Location

LocationLocation Service ProceduresService Procedures

Service Procedures

Service ProceduresService Procedures

Tubing System Water 2Tubing System Water 2

Tubing System Water 2

Tubing System Water 2Tubing System Water 2 Tubing WasteTubing Waste

Tubing Waste

Tubing WasteTubing Waste Tubing Water SupplyTubing Water Supply

Tubing Water Supply

Tubing Water SupplyTubing Water Supply

____________________________________________________________________________________________________

__________________________________________________

____________________________________________________________________________________________________

__________________________________________________________________________________________________________

_____________________________________________________

__________________________________________________________________________________________________________

______________________________________________________________________________________

___________________________________________

______________________________________________________________________________________

____________________________________________________________________________________________________

__________________________________________________

____________________________________________________________________________________________________

________________________________________________________________________________________

____________________________________________

________________________________________________________________________________________

____________________________________________

________________________________________________________________________________________

1010

1010 1010

1010

1111

1111 1111

1111

FINAL 2.1 - February 2000 Chapter 3

Page 87

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FINAL 2.1 - February 2000 Chapter 3

Page 88

Elecsys 1010 Service Manual

3.13.1

3.1

3.13.1

FluidicsFluidics

Fluidics

FluidicsFluidics

Fluidics OverviewFluidics Overview

Fluidics Overview

Fluidics OverviewFluidics Overview

Fig. 740-G-1

FINAL 2.1 - February 2000 Chapter 3Page 1

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Elecsys 1010 Service Manual

3.1.13.1.1

3.1.1

3.1.13.1.1

LegendLegend

Legend

LegendLegend

NameName

Name

NameName

Dilutor Assy S/R Chapter 4.2.9 _______________ page 40 Dilutor Assy Sipper Chapter 4.2.9 _______________ page 40 Needle S/R Chapter 4.2.7 _______________ page 30 Pressure Sensor Assy Chapter 4.2.10 ______________ page 42 Waste/Water Distributor Chapter 4.2.18 ______________ page 58 Membrane Pump PWS Chapter 4.2.13 ______________ page 46 Membrane Pump PWD Chapter 4.2.13 ______________ page 46 Needle Sipper Chapter 4.2.8 _______________ page 35 Valve Block Chapter 4.2.13 ______________ page 46

Location and DescriptionLocation and Description

Location and Description

Location and DescriptionLocation and Description

Bottle Waste Chapter 4.2.18 ______________ page 58 Wash Station WS1 Chapter 4.2.14 ______________ page 50 Wash Station WB1 Chapter 4.2.15 ______________ page 52 Wash Station WD1 Chapter 4.2.17 ______________ page 53 Wash Station WD2 Chapter 4.2.16 ______________ page 54 Water Filter Chapter 4.2.18 ______________ page 58 Distilled Water Bottle Chapter 4.2.11 ______________ page 43 3-Way Distributor Chapter 4.2.12 ______________ page 45 Peltier Assy Preheater Chapter 4.2.4 _______________ page 13 Detection Cell Chapter 4.2.5 _______________ page 22 Waste Pump Chapter 4.2.18 ______________ page 58 Valves Chapter 4.2.13 ______________ page 46 Tubings Chapter 3.2 ________________ page 9

FINAL 2.1 - February 2000 Chapter 3Page 2

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Elecsys 1010 Service Manual

waste container

WB 1

WD 2

WS 1

VAD 1

VAS 1

VAB1

VAD2

VWS1

PSD

VWB1

VWD2

VWD1

PWD

PWS

water filter

ABCDE

5.0

3.6

1.5

1.4

2.4

5.1

3.2

3.1

6.2

3.16

3.15

3.8

3.9

3.10

3.13

3.14

3.11

3.3

3.5

3.4

3.7

4.0

4.1

1.1

4.8

4.0

2.3

1802658 001

1802640 001

1802631 001

1805045 001

1805037 001

4.11

4.13

4.10

4.5

4.21

4.7

1709771 001

1802666 001

1709828 001

4.18

4.19

4.20

4.23

4.22

4.25

4.6

4.14

4.15

4.16

4.17

1904680 001

1905325 001

1801902 001

1906976 001



3.1.2 General Fluidics Drawing

DO dilutor (S/R syringe) SA dilutor (syringe sipper)

system water

measuring cell

S/R needle

sipper tubing (2)

pressure sensor

4.12

preheater

VM1

restrictor tubing

cell tubing 0.8

Adapter

sipper

tubing (1)

sipper needle

water divider

: Silicone tubing 5.0 mm

Silicone tubing 4.0 mm

Special tubing, available on ID number

4.4

: FEP tubing 1.5 mm

FEP tubing 2.0 mm

: Tygon tubing

WD 1

pinch tubing

MIS

waste pump

tubing waste

tubing set waste pump

180 41 62 001

Fig.LIQ_TUB



FINAL 2.1-February 2000 Page 3 Chapter 3

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FINAL 2.1 - February 2000 Chapter 3Page 4

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3.1.33.1.3

3.1.3

3.1.33.1.3

Feeding Pipes to Wash StationsFeeding Pipes to Wash Stations

Feeding Pipes to Wash Stations

Feeding Pipes to Wash StationsFeeding Pipes to Wash Stations WD 1, WD 2, WB 1WD 1, WD 2, WB 1

WD 1, WD 2, WB 1

WD 1, WD 2, WB 1WD 1, WD 2, WB 1

FINAL 2.1 - February 2000 Chapter 3Page 5

Fig. Fluid-3

Page 93

FINAL 2.1 - February 2000 Chapter 3Page 6

WB1WB1

WB1

WB1WB1

WD2WD2

WD2

WD2WD2

yellowyellow

yellow

yellowyellow

greengreen

green

greengreen

redred

red

redred

blueblue

blue

blueblue

yellowyellow

yellow

yellowyellow

naturalnatural

natural

naturalnatural

VAD 2VAD 2

VAD 2

VAD 2VAD 2

WD1WD1

WD1

WD1WD1

3.1.4

3.1.43.1.4

Fluid Station

Fluid StationFluid Station

Elecsys 1010 Service Manual

Fig. Fluid-4

blackblack

black

blackblack

WS1WS1

WS1

WS1WS1

Page 94

Elecsys 1010 Service Manual

3.1.53.1.5

3.1.5

3.1.53.1.5

Water Supply SystemWater Supply System

Water Supply System

Water Supply SystemWater Supply System

FINAL 2.1 - February 2000 Chapter 3Page 7

Fig. Fluid-8

Page 95

Elecsys 1010 Service Manual

3.1.63.1.6

3.1.6

3.1.63.1.6

Waste Tubings, Pump, Distributor,Waste Tubings, Pump, Distributor,

Waste Tubings, Pump, Distributor,

Waste Tubings, Pump, Distributor,Waste Tubings, Pump, Distributor, Tubing to Wash Station WS 1Tubing to Wash Station WS 1

Tubing to Wash Station WS 1

Tubing to Wash Station WS 1Tubing to Wash Station WS 1

FINAL 2.1 - February 2000 Chapter 3Page 8

Fig. Fluid-6

Page 96

Elecsys 1010 Service Manual

3.23.2

3.2

3.23.2

3.2.13.2.1

3.2.1

3.2.13.2.1

3.2.1.13.2.1.1

3.2.1.1

3.2.1.13.2.1.1

Tubing No. Length Ø a Ø i Color from to

TubingsTubings

Tubings

TubingsTubings

Legend for Fluidics OverviewLegend for Fluidics Overview

Legend for Fluidics Overview

Legend for Fluidics OverviewLegend for Fluidics Overview

Tubings System Water 1Tubings System Water 1

Tubings System Water 1

Tubings System Water 1Tubings System Water 1

in mm in mm in mm

1.1 400 3.0 1.5 natural Pressure sensor bottom Dilutor s/r (syringe lateral)

1.4 6 0 0 3.0 1.5 natural Buffer Tank Output "E" PSD (rinsing pump) DD extrem left

2.3 1.950 3.0 1.5 natural Dilutor valvel VSD (right) Valve VM1 (3)

2.4 65 0 3.0 1.5 white Buffer Tank Output "F" Dilutor valve VSD (left)

3. 4 120 3.0 1.5 black Wash station WS1 Y-piece

3. 5 120 3.0 1.5 black Wash station WS1 Y-piece

3.11 20 0 3.0 1.5 red Wash station WB1 Y-piece

3.12 20 0 3.0 1.5 red Wash station WB1 Y-piece

3.13 20 0 3.0 1.5 green Wash station WD1 Y-piece

3.14 20 0 3.0 1.5 green Wash station WD1 Y-piece

3.15 30 0 3.0 1.5 blue Wash station WD1 Y-piece

3.16 30 0 3.0 1.5 blue Wash station WD1 Y-piece

3.2.1.23.2.1.2

3.2.1.2

3.2.1.23.2.1.2

Tubing No. Length Ø a Ø i Color from to

Tubings System Water 2Tubings System Water 2

Tubings System Water 2

Tubings System Water 2Tubings System Water 2

in mm in mm in mm

3.1 150 3 .0 2. 0 yellow Buffer Tank Output "C" Pump PWS entrance

3.2 200 3.0 2.0 natural Pump PWS exit Valve VWS1

3. 3 600 3.0 2.0 black Valve VWS1 Y-piece WS1

3.6 400 3 .0 2.0 yellow Buffer Tank Output "D" Pump PWD entrance

3.7 2 0 0 3.0 2.0 natural Pump PWD exit Valve block s/r system (front)

3.8 30 0 3.0 2.0 blue Y-piece WD1 Valve block VWD1 (right)

3.9 200 3.0 2.0 green Y-piece WD2 Valve block VWD2 (center)

3.10 20 0 3.0 2.0 red Y-piece WB1 Valve block VWB1 (back)

FINAL 2.1 - February 2000 Chapter 3Page 9

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Elecsys 1010 Service Manual

3.2.1.33.2.1.3

3.2.1.3

3.2.1.33.2.1.3

Tubing No. Length Ø o Ø i Color from to

Tubings WasteTubings Waste

Tubings Waste

Tubings WasteTubings Waste

in mm in mm in mm

4.0 600 6.0 3.0 Valve VM1 (2) Collector waste (bottom left)

4.1 100 6.0 3.0 Waste pump top Collector waste (right)

4.2 100 6.0 3.0 Waste pump top Collector waste (right)

4.3 100 6.0 3.0 Waste pump top Collector waste (right)

4.4 100 6.0 3.0 Waste pump top Collector waste (right)

4.5 350 6.0 3.0 Valve VAS 1 (3) Waste pump

4.6 1000 6.0 3.0 Valve VAB 1 (3) Waste pump

4.7 1000 6.0 3.0 Valve VAD 2 (3) Waste pump

4.8 750 6.0 3.0 Y-piece A pinch valve Waste pump

4.10 35 0 6.0 3.0 Wash station WS1 waste bottom Valve VAS 1 (2)

4.11 90 6.0 3.0 Wash station WS1 waste top Y-piece B

4.12 90 6.0 3.0 Wash station WS1 waste top Y-piece B

4.13 20 0 6.0 3.0 Y-piece B Valve VAS1 (1)

4.14 10 0 6.0 3.0 Wash station WD1 waste bottom Y-piece A through VAD1

4.15 10 0 6.0 3.0 Wash station WD1 waste top Y-piece C

4.16 10 0 6.0 3.0 Wash station WD1 waste top Y-piece C

4.17 14 0 6.0 3.0 Y-piece C Y-piece A through VAD1

4.18 90 6.0 3.0 Wash station WD2 waste Valve VAD2 (2)

4.19 90 6.0 3.0 Wash station WD2 waste top Y-piece D

4.20 90 6.0 3.0 Wash station WD2 waste top Y-piece D

4.21 90 6.0 3.0 Y-piece D Valve VAD2 (1)

4.22 90 6.0 3.0 Wash station WB1 waste bottom Valve VAB1 (2)

4.23 20 0 6.0 3.0 Wash station WB1 waste top Y-piece E

4.24 20 0 6.0 3.0 Wash station WB1 waste top Y-piece E

4.25 20 0 6.0 3.0 Y-piece E Valve VAB1 (1)

3.2.1.43.2.1.4

3.2.1.4

3.2.1.43.2.1.4

Tubing Water SupplyTubing Water Supply

Tubing Water Supply

Tubing Water SupplyTubing Water Supply

Tubing No. Length Ø o Ø i Color from to

in mm in mm in mm

5.0 250 6.0 3.0 System Bottle Filter Input

5.1 300 6.0 3.0 Filter Output Buffer Tank Input "B"

6.2 40 0 8 .0 5.0 Buffer Tank Output "A" between electronic rack/ water bottle housing

FINAL 2.1 - February 2000 Chapter 3Page 10

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Elecsys 1010 Service Manual

3.2.23.2.2

3.2.2

3.2.23.2.2

The tubings laid in the analyzer have two different kinds of connections.

- Connection with adapter.

- Connection with fitting. For the connection with fitting a special tool, flange kit for

tubings (403), is required; see chapter 8.1 Special Tools. By using this tool a flange is bent up at the tubing end.

Note!Note!

Note!

Note!Note! Empty the fluidics system before servicing;Empty the fluidics system before servicing;

Empty the fluidics system before servicing;

Empty the fluidics system before servicing;Empty the fluidics system before servicing; see chapter 6 Software.see chapter 6 Software.

see chapter 6 Software.

see chapter 6 Software.see chapter 6 Software. Prime the fluidics system after servicing;Prime the fluidics system after servicing;

Prime the fluidics system after servicing;

Prime the fluidics system after servicing;Prime the fluidics system after servicing; see chapter 6 Software.see chapter 6 Software.

see chapter 6 Software.

see chapter 6 Software.see chapter 6 Software.

3.2.33.2.3

3.2.3

3.2.33.2.3

ConnectionsConnections

Connections

ConnectionsConnections

LocationLocation

Location

LocationLocation

227

412

411

Fig. 2011-05

410

R-3

H-00

3 1 Adapter 33 Fitting, red, yellow, green 3 4 Water/Waste tubing 35 Tubing, normal, part of Set 5 36 Water feeding tubing, part of Set 5 39 Fitting

217 Y-piece

227 Y-piece

351 Tubing Waste

410 Tubing s/r

4 11 Tubing cell 4 12 Tubing sipper (2) 4 13 Tubing sipper (1)

351

217

C-7

413

C-8

3.2.43.2.4

3.2.4

3.2.43.2.4

Exchangeable components:

- Tubing s/r (410)

- Tubing cell (411)

- Tubing sipper (2) (412)

- Tubing sipper (1) (413)

- Tubing set (Set 5), consisting of:

Service ProceduresService Procedures

Service Procedures

Service ProceduresService Procedures

- Adapter (31)

- Fitting, red, yellow, green (33)

- Waste tubing (34)

- Tubing, normal (35)

- Water feeding tubing (36)

- Fitting blank (39)

- Y-piece (217)

- Y-piece (227

FINAL 2.1 - February 2000 Chapter 3Page 11

Page 99

Elecsys 1010 Service Manual

FINAL 2.1 - February 2000 Chapter 3Page 12

Page 100

Elecsys 1010 Service Manual

MechanicsMechanics

Mechanics

MechanicsMechanics

4.1 Mechanical System Overview4.1 Mechanical System Overview

4.1 Mechanical System Overview

4.1 Mechanical System Overview4.1 Mechanical System Overview

4.1.14.1.1

4.1.1

4.1.14.1.1

4.2 Mechanical Modules4.2 Mechanical Modules

4.2 Mechanical Modules

4.2 Mechanical Modules4.2 Mechanical Modules

4.2.14.2.1

4.2.1

4.2.14.2.1

4.2.24.2.2

4.2.2

4.2.24.2.2

4.2.34.2.3

4.2.3

4.2.34.2.3

4.2.44.2.4

4.2.4

4.2.44.2.4

4.2.54.2.5

4.2.5

4.2.54.2.5

4.2.64.2.6

4.2.6

4.2.64.2.6

4.2.74.2.7

4.2.7

4.2.74.2.7

4.2.84.2.8

4.2.8

4.2.84.2.8

Removing of the InstrumentRemoving of the Instrument

Removing of the Instrument

Removing of the InstrumentRemoving of the Instrument Cover Top and Instrument Housing TopCover Top and Instrument Housing Top

Cover Top and Instrument Housing Top

Cover Top and Instrument Housing TopCover Top and Instrument Housing Top

______________________________________________________________________________

_______________________________________

______________________________________________________________________________

HousingHousing

Housing

HousingHousing Keyboard AssyKeyboard Assy

Keyboard Assy

Keyboard AssyKeyboard Assy STAT HolderSTAT Holder

STAT Holder

STAT HolderSTAT Holder Detection ModuleDetection Module

Detection Module

Detection ModuleDetection Module Cell and Reference ElectrodeCell and Reference Electrode

Cell and Reference Electrode

Cell and Reference ElectrodeCell and Reference Electrode MFA AssyMFA Assy

MFA Assy

MFA AssyMFA Assy S/R ArmS/R Arm

S/R Arm

S/R ArmS/R Arm Sipper ArmSipper Arm

Sipper Arm

Sipper ArmSipper Arm

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____________________________________________________________________________________________________________

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1010

1010 1212

1212 1313

1313 2222

2222 2727

2727 2929

2929 3434

3434

4.2.94.2.9

4.2.9

4.2.94.2.9

4.2.104.2.10

4.2.10

4.2.104.2.10

4.2.114.2.11

4.2.11

4.2.114.2.11

4.2.124.2.12

4.2.12

4.2.124.2.12

4.2.134.2.13

4.2.13

4.2.134.2.13

4.2.144.2.14

4.2.14

4.2.144.2.14

4.2.154.2.15

4.2.15

4.2.154.2.15

4.2.164.2.16

4.2.16

4.2.164.2.16

4.2.174.2.17

4.2.17

4.2.174.2.17

4.2.184.2.18

4.2.18

4.2.184.2.18

4.2.194.2.19

4.2.19

4.2.194.2.19

4.2.204.2.20

4.2.20

4.2.204.2.20

4.2.214.2.21

4.2.21

4.2.214.2.21

DilutorsDilutors

Dilutors

DilutorsDilutors Pressure Sensor (Clot Sensor)Pressure Sensor (Clot Sensor)

Pressure Sensor (Clot Sensor)

Pressure Sensor (Clot Sensor)Pressure Sensor (Clot Sensor) Water Supply ModuleWater Supply Module

Water Supply Module

Water Supply ModuleWater Supply Module Buffer TankBuffer Tank

Buffer Tank

Buffer TankBuffer Tank Pumps and ValvesPumps and Valves

Pumps and Valves

Pumps and ValvesPumps and Valves Wash Station SWash Station S

Wash Station S

Wash Station SWash Station S Wash Station BWash Station B

Wash Station B

Wash Station BWash Station B Wash Station D2Wash Station D2

Wash Station D2

Wash Station D2Wash Station D2 Wash Station D1Wash Station D1

Wash Station D1

Wash Station D1Wash Station D1 Waste ModuleWaste Module

Waste Module

Waste ModuleWaste Module Incubator DriveIncubator Drive

Incubator Drive

Incubator DriveIncubator Drive S/R Rotor DriveS/R Rotor Drive

S/R Rotor Drive

S/R Rotor DriveS/R Rotor Drive Bottle Temperature AssyBottle Temperature Assy

Bottle Temperature Assy

Bottle Temperature AssyBottle Temperature Assy

____________________________________________________________________________________________________________

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3939

3939 4141

4141 4242

4242 4444

4444 4545

4545 4949

4949 5151

5151 5353

5353 5555

5555 5757

5757 6060

6060 6262

6262 6464

6464

4.2.224.2.22

4.2.22

4.2.224.2.22

4.2.234.2.23

4.2.23

4.2.234.2.23

4.2.244.2.24

4.2.24

4.2.244.2.24

FINAL 2.1 - February 2000 Chapter 4

OEM MasterOEM Master

OEM Master

OEM MasterOEM Master Floppy DriveFloppy Drive

Floppy Drive

Floppy DriveFloppy Drive PrinterPrinter

Printer

PrinterPrinter

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6666

6666 6868

6868 6969

6969

Roche Elecsys1010 Service manual

Specifications and Main Features

Frequently Asked Questions

User Manual

How to Use this Manual

System Description

Instrument Introduction

Principles of the Analysis

Pipetting Scheme

Timing Diagram

System Specification

1.3.3 Precautions and Hazards

Operator Precautions andOperator Precautions and HazardsHazards

1.3.1 Contact Persons

1.3.2 Proved Security

1.4 Service Concept

Service Level

Introduction

Cleaning Materials

Maintenance Schedule

Bi-weekly Analyzer Maintenance

Perform SYSTEM CLEANINGPerform SYSTEM CLEANING INTENSIVEINTENSIVE

Clean the Sipper Probe

Clean the S/R Probe

Perform CELL CLEANING NORMAL

Maintenance, As Required

Replacing Printer Paper

Clean the Rinse Stations

Half-Yearly, Yearly, SpecialHalf-Yearly, Yearly, Special MaintenanceMaintenance

10.6 Preventive Maintenance

Maintenance Materials

Site Requirements

Inventory

Location

External Computer Installation

Software Installation

Analyzer Installation

Initial Installation

Setup with preinstalled cell

General Information

Cell Exchange

Cell installation

Cell Installation Flow Chart

Installation Checklist Elecsys 1010

Transport PreparationTransport Preparation (Decontamination of the Cell)(Decontamination of the Cell)

DE-Installation and ShippingDE-Installation and Shipping ProcedureProcedure

Fluidics Overview

Legend

3.1.2 General Fluidics Drawing

Feeding Pipes to Wash Stations

Fluid Station

Water Supply System

Waste Tubings, Pump, Distributor,Waste Tubings, Pump, Distributor, Tubing to Wash Station WS 1Tubing to Wash Station WS 1

Tubings

Legend for Fluidics Overview

Tubings System Water 1

Tubings System Water 2

Tubings Waste

Tubing Water Supply

Connections

Location