Roche Elecsys1010 Service manual

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

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

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

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

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

FINAL 2.1 - February 2000

Elecsys 1010 Service Manual

FINAL 2.1 - February 2000

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

Elecsys 1010 Service Manual

FINAL 2.1 - February 2000 Chapter 1

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

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

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

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

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

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

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

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

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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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