frankshospitalworkshop.comtranslate this...

Elecsys 1010 Service Manual

FINAL 2.1 - February 2000

Service ManualService ManualService ManualService ManualService Manual

Elecsys 1010Elecsys 1010Elecsys 1010Elecsys 1010Elecsys 1010



This manual is published byRoche Diagnostics GmbH,

Technical Product Managementand Service Department.

Roche Diagnostics GmbH

All rights reserved.

No part of this publication may bereproduced without the expressed writtenpermission of Roche Diagnostics GmbH.

Disclaimer

Roche Diagnostics GmbH makes no rep-resentation or warranties with respect tothe contents of this documentation andspecifically disclaims any implied warranties,including the implied warranties ofmerchantability and fitness for a particularpurpose.

In no case shallRoche Diagnostics GmbH be liable forincidental or consequential damages.



How to Use this ManualHow to Use this ManualHow to Use this ManualHow 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 componenthas an ID number in the figures.

e.g. Photo Coupler Assy, preadjusted (416)Photo Coupler Assy, preadjusted (416)Photo Coupler Assy, preadjusted (416)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)

D-10

416

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

e.g . Photo Coupler Magnet Home (418)Photo Coupler Magnet Home (418)Photo Coupler Magnet Home (418)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)

418



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

e.g. 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)

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)

NoNoNoNoNo IDIDIDIDID Part Name EnglishPart Name EnglishPart Name EnglishPart Name EnglishPart Name English Spare PartSpare PartSpare PartSpare PartSpare Part BTOBTOBTOBTOBTO RRRRR AAAAA ABCABCABCABCABC

326 1234567890 HOLDER PHOTO COUPLER MD1 X A416416416416416 Photo Coupler Assy, preadjusted, Part of 326Photo Coupler Assy, preadjusted, Part of 326Photo Coupler Assy, preadjusted, Part of 326Photo Coupler Assy, preadjusted, Part of 326Photo Coupler Assy, preadjusted, Part of 326418418418418418 Photo Coupler Assy, preadjusted, Part of 326Photo Coupler Assy, preadjusted, Part of 326Photo Coupler Assy, preadjusted, Part of 326Photo Coupler Assy, preadjusted, Part of 326Photo Coupler Assy, preadjusted, Part of 326419 Photo Coupler Holder, Part of 326327 Photo Coupler Holder, Part of 326

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


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


NoNoNoNoNo Part Name EnglishPart Name EnglishPart Name EnglishPart Name EnglishPart Name English ElectronicsElectronicsElectronicsElectronicsElectronics MechanicsMechanicsMechanicsMechanicsMechanics

412 TUBING SIPPER (2) 0,8 Detection Module416416416416416 Photo Coupler Assy, preadjustedPhoto Coupler Assy, preadjustedPhoto Coupler Assy, preadjustedPhoto Coupler Assy, preadjustedPhoto Coupler Assy, preadjusted BP 1BP 1BP 1BP 1BP 1 Detection ModuleDetection ModuleDetection ModuleDetection ModuleDetection Module417 Eccentric Ring, 2 pcs Detection Module418418418418418 Photo Coupler Assy, preadjustedPhoto Coupler Assy, preadjustedPhoto Coupler Assy, preadjustedPhoto Coupler Assy, preadjustedPhoto Coupler Assy, preadjusted BP 1BP 1BP 1BP 1BP 1 Detection ModuleDetection ModuleDetection ModuleDetection ModuleDetection Module419 Photo Coupler Holder Detection Module527 Cable M10 Detection Module



11111 Application / IntroductionApplication / IntroductionApplication / IntroductionApplication / IntroductionApplication / Introduction

22222 InstallationInstallationInstallationInstallationInstallation

33333 FluidicsFluidicsFluidicsFluidicsFluidics

44444 MechanicsMechanicsMechanicsMechanicsMechanics

55555 ElectronicsElectronicsElectronicsElectronicsElectronics

66666 SoftwareSoftwareSoftwareSoftwareSoftware

77777 Trouble ShootingTrouble ShootingTrouble ShootingTrouble ShootingTrouble Shooting

88888 Spare PartsSpare PartsSpare PartsSpare PartsSpare Parts

99999 Host InterfaceHost InterfaceHost InterfaceHost InterfaceHost Interface

1010101010 MaintenanceMaintenanceMaintenanceMaintenanceMaintenance

AppendixAppendixAppendixAppendixAppendix


FINAL 2.1 - February 2000 Chapter 1

11111 Application / IntroductionApplication / IntroductionApplication / IntroductionApplication / IntroductionApplication / Introduction

1.11.11.11.11.1 System DescriptionSystem DescriptionSystem DescriptionSystem DescriptionSystem Description ________________________________________________________________________________________________________________________________________________________________________________________________________11111

1.1.11.1.11.1.11.1.11.1.1 Instrument IntroductionInstrument IntroductionInstrument IntroductionInstrument IntroductionInstrument Introduction __________________________________________________________________________________________________________________________________________________________________________________________________________________ 11111

1.1.21.1.21.1.21.1.21.1.2 Principles of the AnalysisPrinciples of the AnalysisPrinciples of the AnalysisPrinciples of the AnalysisPrinciples of the Analysis ________________________________________________________________________________________________________________________________________________________________________________________________________ 55555

1.1.31.1.31.1.31.1.31.1.3 Pipetting SchemePipetting SchemePipetting SchemePipetting SchemePipetting Scheme ___________________________________________________________________________________________________________________________________________________________________________________________________________________________________________ 66666

1.1.3.11.1.3.11.1.3.11.1.3.11.1.3.1 Timing DiagramTiming DiagramTiming DiagramTiming DiagramTiming Diagram _____________________________________________________________________________________________________________________________________________________________________________________________________________ 1515151515

1.21.21.21.21.2 System SpecificationSystem SpecificationSystem SpecificationSystem SpecificationSystem Specification _________________________________________________________________________________________________________________________________________________________________________________________1818181818

11111.3.3.3.3.3 Operator Precautions andOperator Precautions andOperator Precautions andOperator Precautions andOperator Precautions andHazardsHazardsHazardsHazardsHazards _________________________________________________________________________________________________________________________________________________________________________________________________________________________________2020202020

1.3.11.3.11.3.11.3.11.3.1 Contact PersonsContact PersonsContact PersonsContact PersonsContact Persons ______________________________________________________________________________________________________________________________________________________________________________________________________________________________________ 2020202020

1.3.21.3.21.3.21.3.21.3.2 Proved SecurityProved SecurityProved SecurityProved SecurityProved Security ___________________________________________________________________________________________________________________________________________________________________________________________________________________________________________ 2020202020

1.3.31.3.31.3.31.3.31.3.3 Precautions and HazardsPrecautions and HazardsPrecautions and HazardsPrecautions and HazardsPrecautions and Hazards ___________________________________________________________________________________________________________________________________________________________________________________________________ 2020202020

1.41.41.41.41.4 Service ConceptService ConceptService ConceptService ConceptService Concept _____________________________________________________________________________________________________________________________________________________________________________________________________________2222222222

1.4.11.4.11.4.11.4.11.4.1 Service LevelService LevelService LevelService LevelService Level _____________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________ 2222222222

1.4.21.4.21.4.21.4.21.4.2 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) ____________________________________________________________________________________________________ 2222222222


FINAL 2.1 - February 2000 Chapter 1Page 1

1.11.11.11.11.1 System DescriptionSystem DescriptionSystem DescriptionSystem DescriptionSystem Description

1.1.11.1.11.1.11.1.11.1.1 Instrument IntroductionInstrument IntroductionInstrument IntroductionInstrument IntroductionInstrument Introduction

Pick-up of incubate andaddition of wash and buffersolutions

Pick-up of sample andreagents

Incubation

S/R dilutorClot detection

S/R rotorMFA s/r

Incubation rotorTemperature (incubator)

Sipper dilutorMFA assy (sipper)

PMTTemperature

Measuring cellPotentiostat

The sequence of operation of Elecsys 1010 is as follows:

Bottle temperature

Measurement ofluminescence, dataevaluation and output

F-9F-9F-9F-9F-9



IntroductionIntroductionIntroductionIntroductionIntroduction

This System Description explains functions and theirinterrelationship.

Short Description of the InstrumentShort Description of the InstrumentShort Description of the InstrumentShort Description of the InstrumentShort Description of the Instrument

The Elecsys 1010 is a Multi-Batch-Analyzer which analyzesimmunological tests according to the principle of electro-chemical luminescence (ECL). This measuring system isalso called ORIGEN technology. The emitted photons aremeasured with a photomultiplier (photon counts).

Elecsys 1010 has all the modules and componentsnecessary for executing the entire analysis including themeasurements and evaluation. When operating theinstrument (e.g. for test selection and sample placement),the user is guided by menus on the keyboard. Softkeys andfunction keys can be used for interacting with theinstrument. Samples (both in primary tubes and in secondarycups), reagents and calibrators are to be positioned on thesample/ reagent (s/r) rotor. A special reagent bottlecombination (RackPack) contains the reagents needed fora test. Each RackPack has a 2-dimensional bar code withall data specific of the test. Positive user identification(PSID) is possible with samples in primary tubes. Withsamples in secondary cups, patients are identified manuallyby using the keyboard. After reading the bar code, the RUNis started and performed automatically.

CalibrationCalibrationCalibrationCalibrationCalibration

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 2levels).

Quality ControlQuality ControlQuality ControlQuality ControlQuality Control

The instrument software contains all programs necessaryfor the quality control. Data input, management and securityis done by using the keyboard.

Instrument AssemblyInstrument AssemblyInstrument AssemblyInstrument AssemblyInstrument Assembly

ELECSYS 1010 is a desk top model and is suitable for astandard laboratory bench. The instrument can be loadedfrom the front. The instrument cover top must be closedduring the RUN.

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

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

When the instrument cover top is closed, loading of twoSTAT (short-turn-around-time) samples is possible outsideof the direct range of action of the MFA arms and rotors. Pullout the control panel like a drawer, behind which the holderfor the above mentioned STAT samples is located. Bypushing the control panel back in, the STAT samples arewithin the direct range of the pipette needle under the closedinstrument cover without mechanically or logicallyinterrupting an ongoing process.

Elecsys 1010 has two driving blocks for the sample/reagent rotor and the incubation rotor.

The sample/reagent rotor is divided into 6 segments. Thetwo outer trays can hold samples in so-called primary tubesof various diameters and heights. Control and calibratorliquids are normally also positioned in these trays. Amaximum of 6 RackPacks with 2 reagents and one beadcontainer each are arranged radially between the samplesegments. The two inner trays are provided for secondarycups. The labels on the primary tubes on the two outer traysand the RackPacks can be read by a bar-code reader(BCR).

The rotor assy is equipped with toothed disks and LEDs forcontrolling and checking the rotor functions. The sample/reagent rotor is removable.

The incubation rotor is an aluminum block heated to 37C.It can hold 4 identical segments with 32 incubation vesselseach. These incubation vessels are small conical plastictubes that hold the incubation material. When preparing theRUN, the user loads the incubation rotor with the 4 segments.The incubation rotor is not removable.

Detection ModuleDetection ModuleDetection ModuleDetection ModuleDetection Module

The ECL measuring cell is located in the detection module.The photomultiplier (PMT), which is shielded fromelectromagnetic radiation by a special housing, as well asthe holder for the pre-amplifier and the high-voltage moduleare located above the measuring cell. The magnet with thedrive for the bead capturing is under the measuring cell. Themagnet is moved vertically from below to the bottom of themeasuring cell by a motor/spindle unit. This internalassembly is incorporated in a housing, which serves as anoptical, electrical and thermal shield. The optimumtemperature for the process of ORIGEN technology is28C. Therefore, the temperature of the entire detectionmodule is set at 28C.

MFA AssysMFA AssysMFA AssysMFA AssysMFA Assys

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

the incubation vessels andb) incubation material as well as ProCell and CleanCell

to the measuring cell.

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



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

Arms are mounted on the MFAs. The sample arm holds thesample needle and the bead mixer. The sipper arm holdsthe sipper needle. The LLD electronic system and thecontact sensory system (crash detection) are also locatedin the arms. The assembly of both MFAs is identical exceptfor the arm adapters.

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

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

Bottle TemperatureBottle TemperatureBottle TemperatureBottle TemperatureBottle Temperature

Elecsys 1010 has 2 bottle temperature systems, one forProCell bottle and one for CleanCell bottle. Bottles arerefrigerated to approx. 8C and will reach the desiredtemperature of 28C after approx. 1hr. The actualtemperature is controlled by NTC resistors in the housingwalls.

DilutorsDilutorsDilutorsDilutorsDilutors

Elecsys 1010 has 2 dilutors. These are glass cylinders inwhich pistons are precisely moved at a defined number ofincrements. When going down, liquids are aspirated. Whengoing up, an exact amount of liquid is discharged bydisplacement. The direction of the liquid flow can becontrolled 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, reagentsand microparticles in a defined sequence. The media areseparated from the system liquid (H2O) by an air bubble.The aspirated material is discharged into the incubationvessels through the sample needle. After the sample/reagent process, the needle is internally cleaned withsystem water by means of the rinsing pump.

The sipper dilutor is located behind the measuring cell andpulls the incubate, ProCell and CleanCell in a definedsequence through the measuring cell. Then themeasurement is performed. After that the needle is internallyrinsed with CleanCell. The needle is externally cleaned withsystem water.

PumpsPumpsPumpsPumpsPumps

The instrument has 4 built-in pumps. The waste pump, aperistaltic pump, pumps the measuring material and systemliquids into the waste container. The wash stations are fed

by two membrane pumps.Another membrane pump is located on the back of thes/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.

ValvesValvesValvesValvesValves

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

Wash StationsWash StationsWash StationsWash StationsWash Stations

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

LLDLLDLLDLLDLLD

The s/r and the sipper needle have one liquid level detectionunit (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 DetectionClot DetectionClot DetectionClot Detection

On the sample/reagent side, there is a risk of (blood) clotformation in the samples. This can be caused by pollutionand/or belated clotting of the samples. Changes in thevacuum profile when picking up the samples are identifiedas clots by means of a differential pressure converter. Theappropriate cleaning steps will be taken.

PMTPMTPMTPMTPMT

The photomultiplier tube (PMT) receives and amplifies theluminescence signal and converts it to an equivalent voltage.The PMT window is located at a defined distance verticallyabove the cell work electrode. High-voltage power supplyis required for amplification.

High-VoltageHigh-VoltageHigh-VoltageHigh-VoltageHigh-Voltage

High-voltage is used for amplifying the luminescence signalgenerated in the measuring cell. The control range spansfrom 500 V to1100 V.

PotentiostatPotentiostatPotentiostatPotentiostatPotentiostat

The potentiostat controls the electrochemical redox processin the cell.



Measuring CellMeasuring CellMeasuring CellMeasuring CellMeasuring Cell

The cell has three electrodes: the work electrode (on whichthe microparticles are deposited), the counter electrodeand the reference electrode. For the measurement, aconstant voltage is applied between work electrode andcounter electrode.

Rotor / Dilutor / MFA DrivesRotor / Dilutor / MFA DrivesRotor / Dilutor / MFA DrivesRotor / Dilutor / MFA DrivesRotor / Dilutor / MFA Drives

The rotors, dilutor pistons and the MFAs are moved bystepping motors. In order to avoid the loss of steps, themotions are controlled by photo couplers and tootheddisks. Moreover, forward/backward motions can berecognized by two photo couplers placed at an angle of 90.

TemperaturesTemperaturesTemperaturesTemperaturesTemperatures

Elecsys 1010 has 4 systems for setting the temperaturesof liquids.

The luminescence liquid is measured at a temperature of28C. The temperatures of the incubate picked up by theincubator and the liquids used for the measurements(CleanCell and ProCell) are preset inside the detectionmodule. The immunological reaction occurs at 37C(incubator temperature).

PCPCPCPCPC

The PC is a standard PC assembly (CPU 486 DX 2,66MHz, 8MB RAM) with Roche-owned functions. An 1.44MB floppy disk drive serves as drive a. The system can bestarted and reloaded from disk drive a:. A flash-E2PROMserves as a hard disk replacement. The general programand changeable parameters are filed here. The LC displayis controlled by the VGA controller.

Keyboard AssyKeyboard AssyKeyboard AssyKeyboard AssyKeyboard Assy

The keyboard assy consists of the keyboard, the keyboardcontroller, an acoustic signal transmitter, the LC displayand some LEDs. The keys are short-stroke touch contactkeys. An additional keyboard can be connected to thebottom side of the keyboard assy by using a 5-pin plug(standard keyboard plug). One non-standard function is asignal transmitter (piezo) that can be activated on severalfrequencies. The display is a 640 x 480 dot LC display. Inorder to prevent reflections when reading the display in thekeyboard assy drawer, it is possible to incline it.

PrinterPrinterPrinterPrinterPrinter

Elecsys 1010 has a thermoprinter with a printing width of640 pixels. This corresponds to the display resolution. Animmediate hard copy output is possible.

Power Supply AssyPower Supply AssyPower Supply AssyPower Supply AssyPower Supply Assy

It is equipped with an input for input voltages of approx. 80- 260 volts and 50-60 Hz. The fuses are not accessible tothe customer and can only be exchanged by servicepersonnel.

Barcode Reader / BCRBarcode Reader / BCRBarcode Reader / BCRBarcode Reader / BCRBarcode Reader / BCR

A bar-code reader (BCR) is attached to the sample/reagentrotor. It reads and decodes primary sample tubes (on the1st and 2nd tray on the rotor) and reagent RackPackswhenever the rotor passes the reader and transfers thedata to the PC by a built-in RS 232 interface. The readerdecodes 2-dimensional (PDF 417) and all standard barcodes.

Software Distribution /ProcessorsSoftware Distribution /ProcessorsSoftware Distribution /ProcessorsSoftware Distribution /ProcessorsSoftware Distribution /Processors

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



1.1.21.1.21.1.21.1.21.1.2 Principles of the AnalysisPrinciples of the AnalysisPrinciples of the AnalysisPrinciples of the AnalysisPrinciples of the Analysis

See Chapter 5 of the Operator's Manual fordetails of the test principles used on Elecsys1010.



1.1.31.1.31.1.31.1.31.1.3 Pipetting SchemePipetting SchemePipetting SchemePipetting SchemePipetting Scheme

Run

This chapter describes processes going on in differenttests, e g. the placement of STAT samples during the run,the automatic rerun and the system preparation afterstart, as well as system evaluation at the end of a run.

Assay Protocols

There are 24 independent assay protocols used fordetermining the pipetting scheme of tests. Furtherprotocols (no. 24 to no. 26) are used for checking theinstrument.

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

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

(in special RackPack)PS: Prereaction solution (pretreatment solution in

special RackPack)RI: Reagent 1 (assay RackPack )R2: Reagent 2 (assay RackPack )S: Undiluted sample/ calibrator/ checkDL: Diluted sample/ calibrator/ checkD: Aspiration into the measuring cell and optical

detectioni: Incubation time

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

1. Aspirate R0 and sample S --> discharge both liquidsinto the first incubation container.

2. Aspirate R0 and the diluted sample DL from the firstincubation vessel --> discharge both liquids into thesecond incubation vessel.

3. Aspirate microparticles, R1 and the diluted sampleDL from the second incubation vessel --> dischargeall three liquids into the third incubation vessel.

4. Wait until the incubation time i1 is over.

5. Aspirate R2 --> discharge R2 into the third incubationvessel.

6. Wait until incubation time i2 is over.

7. Measurement.

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



Assay ProtocolsAssay ProtocolsAssay ProtocolsAssay ProtocolsAssay Protocols

TableTableTableTableTable

No. Pipetting Step 0 Inc 0 Pipetting Step1 Inc 1Pipetting Step

2 Inc 2 Det.Main assay Remarks

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

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 Xonly needed

for instrumentchecks,

25 R1 R2 D Xnot part ofthe RUN

26 R2 R2 D X

27 R1 B i1 D X

28

29...

... Reserve

...63

E-Tab1: Assay Protocols



Pipetting StepsPipetting StepsPipetting StepsPipetting StepsPipetting Steps

The processing of the assay protocols is divided into fourpipetting steps: pipetting step 0, the so-called pretreatmentstep, pipetting steps1 and 2, and the measuring step. Thepipetting steps are divided into partial steps (e.g. pipette R1).The sequence of the partial steps is (regarding the liquid pick-up by the s/r needle): R1, R2, B, S.

The pipetting steps / partial steps according to the assayprotocols are described below. The pick-up sequenceduring pretreatment is always: reagent before sample (inboth steps).

For each pipetting step and/or measuring step, a generallyapplicable step can be described. Figures 1 to 3 give anoverview of these pipetting steps.

Pipetting Step 0Pipetting Step 0Pipetting Step 0Pipetting Step 0Pipetting Step 0

In pipetting step 0 the sample is pretreated. It has one or twoincrements. In the figure, these increments are called "Block1 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 themicroparticles and washing

Rinsing and washing in wash station 2 with simultaneousrehomogenizing of the microparticles can only beperformed one time, always at the end of a pipetting step.

The difference between block 1 and block 2 is theaspiration 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 firstincubation vessel.

- In block 2, the sample is aspirated from the firstincubation vessel, and the liquids are discharged intothe second incubation vessel.




Wash in wash station 1

S

Aspirate pretreatmentliquid by using LLD


DL Aspirate pretreated sample

by using LLD

R0 or RM

Sample rotor Incubation rotor

Aspirate

Aspirate

Aspirate

Discharge

Aspirate

Figure 1: Pipetting step 0

Block 1Block 1Block 1Block 1Block 1


Aspirate sample by usingLLD

Discharge

Discharge

Discharge

Aspirate separation air bubble

Wash and rinse inwash station 1

R0 or PS or RM


Wash and rinsein wash station 1

Aspirate sample by usingLLD

Wash and rinse inwash station 2 and

rehomogenize microparticles






Pipetting step 1 is also divided into blocks and alwaysstarts with block 1.

- Aspirate the separation air bubble.

In blocks 2, 3 and 4, reagents are aspirated. All threeblocks 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. Thesample pretreated with PS will be further processed inblock 6.

- Washing in wash station 1.

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

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

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

- aspirated from the second incubation vessel and isdischarged into a third incubation vessel in block 6, ifit 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 fromthe sample rotor and discharged into the first incubation vesselin 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 beenpretreated with PS, the aspirated liquids will be added to thefirst incubation vessel (see pipetting step 0).The rehomogenizing of the microparticles and the was-hing /rinsing in wash station 2 will be performed if in thenext cycle microparticles are pipetted in one pipettingstep 1.





DLSAspirate sample byusing LLD (clot and

foam detection)

Aspirate pretreatedsample by using LLD

Aspirate microparticlesby using LLD

Aspirate reagent 2by using LLD

R2



R1

Microparticles


Aspirate





Aspirate

Aspirate



Aspirate Aspirate



Wash and rinse in washstation 2 and rehomogenize

microparticles

Discharge

Wash and rinse in wash station 1

Discharge samplepretreated with PS





Pipetting step 2 is divided into 4 blocks. Like pipettingstep 1, it always starts with block 1:

- Aspirate the separation air bubble.

In blocks 2 and 3, reagents are aspirated. Both blocks arepassed 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 theblocks 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 hasnot been pretreated or pretreated with PS.

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

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

The rehomogenizing of the microparticles and the was-hing /rinsing in wash station 2 will be performed if in thenext cycle microparticles are pipetted in one pipettingstep 1.







wachen und splen in

Aspirate

Aspirate microparticles byusing LLD


R2






Aspirate

Discharge


Wash and rinse i nwash station 1



Microparticles



Measuring StepMeasuring StepMeasuring StepMeasuring StepMeasuring Step

Measuring step actions take place around the measuringcell, e.g. in the incubator, sipper needle, measuring cellor in the sipper system dilutor. The measuring step hasthe following increments:

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

- Transport of the incubate with ProCell (pre-conditioning 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



1.1.3.11.1.3.11.1.3.11.1.3.11.1.3.1 Timing DiagramTiming DiagramTiming DiagramTiming DiagramTiming Diagram

diag1.tif



diag2.tif



diag3.tif



1.21.21.21.21.2 System SpecificationSystem SpecificationSystem SpecificationSystem SpecificationSystem Specification

E-Tab2

Analyzer dimensions Height: 620 (mm)

Depth: 780 (mm)

Width: 960 (mm)

Weight approx. 110 (kg)

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

Power consumption max 0.61 (kVA)

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

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

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

Ambient temperature note change duringone batch run max. 3 (C)

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

Noise level according to DIN43635 Continuous operation max. 60 (dBA)

Peak level max. 65 (dBA)

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

Water quality (conductivity) sub-micron filtered



E-Tab3

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 (l)

Incubation temperature

ambient temperature 18C to 20C37C + 0.3C - 0.8Cambient temperature 20C to 32C37C + 0.3C - 0.3C

Incubation time 9 / 18 (min)

Measuring system Measuring method Integral measurement of luminescencesignal

Calibration method 2 point calibration

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

Interfaces 1 Centronics for printer, 1 RS 232 forlaboratory EDP

LCD Black-and-white VGA LCD with 640 x480 pixels

Thermoprinter Paper width 110 (mm)



1.31.31.31.31.3 Operator Precautions andOperator Precautions andOperator Precautions andOperator Precautions andOperator Precautions andHazardsHazardsHazardsHazardsHazards

The data and information provided in this manual correspondto the state of knowledge existing at the time of introducingthe Elecsys 1010 onto the market. Any important changeswill be taken into account in the next edition of this manual.

The respective packaging leaflet should be regarded asauthoritative.

This service manual was created for the telephone andtechnical service staff.

1.3.1 Contact Persons1.3.1 Contact Persons1.3.1 Contact Persons1.3.1 Contact Persons1.3.1 Contact Persons

Technical Product Management and Support

Department: LI-TT

Phone: 0621 / 759 / 32278802

Fax No: 0621/ 759 / 4591

Logistics Hotline (RA):

Phone: 0621 / 759 / 4389

Fax No.: 0621 / 759 / 46138093

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

1.3.2 Proved Security1.3.2 Proved Security1.3.2 Proved Security1.3.2 Proved Security1.3.2 Proved Security

This instrument has been constructed according to theregulations of DIN IEC 601, part: "Security of ElectromedicalInstruments: General Guidelines" and left our factory inperfect condition regarding work safety.

The instrument obtained the GS mark for proved securityfrom the TV.

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

This instruments meets protection 1 (earth conductor wire).

1.3.3 Precautions and Hazards1.3.3 Precautions and Hazards1.3.3 Precautions and Hazards1.3.3 Precautions and Hazards1.3.3 Precautions and Hazards

All electrical equipment is potentially hazardous. Neverremove covers without first ensuring that it is isolated fromthe AC supply, unless specific maintenance instructions orrepairs are being carried out by authorized RocheDiagnostics personnel.

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

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

Warning:Warning:Warning:Warning:Warning:

All components used on Elecsys 1010 must be regardedas potentially dangerously contaminated when doing repairwork. Use rubber gloves or double gloves whenever cleaningor sterilizing components. the most frequently usedcomponents (tubings, cuvette, measuring chamber flap,sip. lever and waste container) should be cleaned andtreated 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 inaccordance with Standards IEC 1010. When the instrumentleaves our factory it is in perfect order from the point of viewof work safety. To keep it that way and to ensure safeoperation the user must follow the instructions and warningsgiven in the operation instruction manual.

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

The power plug must only be inserted into a socket that hasa protective contact. The protection must not be abolishedby using an extension lead that does not have a protectiveearth wire.


Any break in the earth wire inside or outside the apparatusand any loose connection of the earth wire can make theoperation of the apparatus dangerous. A deliberate breakor interruption is not allowed.

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

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



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

If you have any reason to believe that the instrument can nolonger operate safely, take it out of use and make sure noone can use it accidentally.

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

- shows visible signs of damage

- fails to operate

- has been stored under unfavourable conditions fora fairly long time

- has been transported under rough conditions

The Elecsys 1010 should be used by appropriately qualifiedpersons only.


In order to avoid electrostatic charging when working on theelectronics, use a grounding strap and a grounding mat.

For more information, please refer to operator manual.



1.4 Service Concept1.4 Service Concept1.4 Service Concept1.4 Service Concept1.4 Service Concept

1.4.11.4.11.4.11.4.11.4.1 Service LevelService LevelService LevelService LevelService Level

From the early stage of development, Elecsys 1010 wasdesigned for simple error detection and easy exchangeabilityof modules. This gives the service workshops the possibilityof a fast and easy repair of the instrument on service levelA (module level). No big stock or expensive equipment isnecessary and service technicians are easier to train.Also, a permanent technical improvement in layout andcomponents took and takes place for better productivityand economic production.

On repairable modules the quality and function is alwaysprovided by the manufacturer according to the latesttechnology. This keeps Elecsys 1010 always on the highestquality level.

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

1.4.21.4.21.4.21.4.21.4.2 RA-Procedure (Replacement ofRA-Procedure (Replacement ofRA-Procedure (Replacement ofRA-Procedure (Replacement ofRA-Procedure (Replacement ofdefective parts)defective parts)defective parts)defective parts)defective parts)

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

The warranty period for instruments is 16 months startingwith the date of shipment ex works Mannheim/FederalRepublic of Germany or 12 months starting with the date ofthe first installation, whichever period is shorter.The warranty period for spare parts is 6 months frominstallation date of the part, however not longer than 24months after having delivered ex works Mannheim/FederalRepublic of Germany. Note: In case the instrument has aremaining warranty period of more than 6 months, the partsremain under warranty until the warranty period of theinstrument expires.

Handling of warranty claimsHandling of warranty claimsHandling of warranty claimsHandling of warranty claimsHandling of warranty claims

The warranty claim has to be handled via ReturnAuthorization procedure or accepted equivalent. Pleaseanswer all the questions on the RA form with the greatestcare.Especially a detailed fault description is needed or thewarranty claim will not be accepted by the manufacturer.Complete instruments are not accepted unless this hasbeen agreed with the service department of the relevantproduct group responsible at RD GmbH.

Important informationImportant informationImportant informationImportant informationImportant information

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

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

- Warranty claim for R parts will be accepted, if thepart was returned to Mannheim.

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

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

- The RA claim for warranty has to be in Mannheim nolater than 8 weeks after the problem date.

Exclusion of warrantyExclusion of warrantyExclusion of warrantyExclusion of warrantyExclusion of warranty

The aforementioned warranties do not apply in case ofimproper use, handling, transportation or storage, faultyinstallation, repair or maintenance, chemical influence orcontamination as well as damages resulting from that,failure to follow operating instructions, alterations ormodifications of instruments or parts thereof not authorizedor recommended by RD GmbH and resulting damages,normal wear and tear and in case of other circumstancesbeyond the control of RD GmbH.

Handling of repairsHandling of repairsHandling of repairsHandling of repairsHandling of repairs

As a general rule, all instrument repairs should be carriedout by authorized and trained personnel only.

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 markedwith "R" in the spare parts price list. New and repaired partscould be recognized by different material numbers (languageversion).

(e.g. new part: 1234567-001, repaired part: 1234567-984)

Repaired parts should be ordered together with new partsvia the order processing department in Mannheim (OU-VDG). Parallel to the ordering process of a repaired part,the defective part should be returned together with the filledRA form (giving full details of the defect and marked choicebox with repair) to Logistic Instruments (Goods Receipt) inMA-Wohlgelegen (LI-GS). Repair of instrumentsCompleteinstruments are not accepted for replacement or repairunless this has been agreed with the product groupresponsible at RD GmbH. Before replacement or repaircan take place, the validity of the request must be examinedand the question of costs must be settled in a writtenagreement with RD GmbH.

Terms of deliveryTerms of deliveryTerms of deliveryTerms of deliveryTerms of delivery

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 becharged.



Handling of costsHandling of costsHandling of costsHandling of costsHandling of costs

Repaired-parts (Material-No. 1234567-984) are shippedat a repair price. In case the defective parts are not returnedwithin 3 or 8 weeks for european or oversea countries afterordering the repaired part, the countries will be chargedlater on with the difference to the new price.After the receiptof a warranty request for A-parts, RDG will credit 100 %of the currently effective ex MA price.In case themanufacturer does not accept the warranty request, thecountries will be charged lateron with the R-price for R-parts and the new price for non R-parts.

RA formRA formRA formRA formRA form

Return Authorization. Please answer all the questions onthe 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 warrantyIn case of instrument out of warrantyIn 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 thecorresponding RA No. and shipped together with thecompleted RA form to:

Roche Diagnostics GmbHLogistic InstrumentsRA ManagementFriedrich Ebert Str. 100D - 68167 MannheimGermany



RA Form:RA Form:RA Form:RA Form:RA Form:

A copy of the RA Form is shown below.

Fig.: RA.eps

Roche Diagnostics

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

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

Germany

Return AuthorizationNo.:

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

RD




10.110.110.110.110.1 IntroductionIntroductionIntroductionIntroductionIntroduction _________________________________________________________________________________________________________________________________________________________________________________________________________________________________ 11111

10.1.110.1.110.1.110.1.110.1.1 Cleaning MaterialsCleaning MaterialsCleaning MaterialsCleaning MaterialsCleaning Materials _________________________________________________________________________________________________________________________________________________________________________________________________________________________________ 11111

10.210.210.210.210.2 Maintenance ScheduleMaintenance ScheduleMaintenance ScheduleMaintenance ScheduleMaintenance Schedule ____________________________________________________________________________________________________________________________________________________________________________________ 33333

10.310.310.310.310.3 Bi-weekly Analyzer MaintenanceBi-weekly Analyzer MaintenanceBi-weekly Analyzer MaintenanceBi-weekly Analyzer MaintenanceBi-weekly Analyzer Maintenance _______________________________________________________________________________________________________________________________________ 55555

10.3.110.3.110.3.110.3.110.3.1 Perform SYSTEM CLEANING INTENSIVEPerform SYSTEM CLEANING INTENSIVEPerform SYSTEM CLEANING INTENSIVEPerform SYSTEM CLEANING INTENSIVEPerform SYSTEM CLEANING INTENSIVE _____________________________________________________________________________________________________________________________ 5555510.3.210.3.210.3.210.3.210.3.2 Clean the Microparticle MixerClean the Microparticle MixerClean the Microparticle MixerClean the Microparticle MixerClean the Microparticle Mixer ____________________________________________________________________________________________________________________________________________________________________________________ 6666610.3.310.3.310.3.310.3.310.3.3 Clean the Sipper ProbeClean the Sipper ProbeClean the Sipper ProbeClean the Sipper ProbeClean the Sipper Probe _____________________________________________________________________________________________________________________________________________________________________________________________________________ 6666610.3.410.3.410.3.410.3.410.3.4 Clean the S/R ProbeClean the S/R ProbeClean the S/R ProbeClean the S/R ProbeClean the S/R Probe ____________________________________________________________________________________________________________________________________________________________________________________________________________________________ 7777710.3.510.3.510.3.510.3.510.3.5 Perform CELL CLEANING NORMALPerform CELL CLEANING NORMALPerform CELL CLEANING NORMALPerform CELL CLEANING NORMALPerform CELL CLEANING NORMAL ______________________________________________________________________________________________________________________________________________________ 88888

10.410.410.410.410.4 Maintenance, As RequiredMaintenance, As RequiredMaintenance, As RequiredMaintenance, As RequiredMaintenance, As Required ________________________________________________________________________________________________________________________________________________________________ 1010101010

10.4.110.4.110.4.110.4.110.4.1 Clean the Analyzer Surfaces and CoverClean the Analyzer Surfaces and CoverClean the Analyzer Surfaces and CoverClean the Analyzer Surfaces and CoverClean the Analyzer Surfaces and Cover __________________________________________________________________________________________________________________________________ 101010101010.4.210.4.210.4.210.4.210.4.2 Replacing Printer PaperReplacing Printer PaperReplacing Printer PaperReplacing Printer PaperReplacing Printer Paper ________________________________________________________________________________________________________________________________________________________________________________________________________ 101010101010.4.310.4.310.4.310.4.310.4.3 Clean the Rinse StationsClean the Rinse StationsClean the Rinse StationsClean the Rinse StationsClean the Rinse Stations ___________________________________________________________________________________________________________________________________________________________________________________________________ 1010101010

10.510.510.510.510.5 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 _______________________________________________________________________________________________ 1212121212

10.6 Preventive Maintenance10.6 Preventive Maintenance10.6 Preventive Maintenance10.6 Preventive Maintenance10.6 Preventive Maintenance__________________________________________________________________________________________________________________________________________________________________________ 2020202020

10.710.710.710.710.7 Maintenance MaterialsMaintenance MaterialsMaintenance MaterialsMaintenance MaterialsMaintenance Materials _______________________________________________________________________________________________________________________________________________________________________________ 2222222222




10.110.110.110.110.1 IntroductionIntroductionIntroductionIntroductionIntroduction

WARNINGWARNINGWARNINGWARNINGWARNING

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

All analyzer components that can come in contact withbiological substances are potentially biohazardous andcan endanger the health of an operator. Therefore, onlyperform care and maintenance procedures according tonational, international and general laboratory safetyregulations.

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

10.1.110.1.110.1.110.1.110.1.1 Cleaning MaterialsCleaning MaterialsCleaning MaterialsCleaning MaterialsCleaning Materials

The following materials are generally required for careand maintenance procedures:

- Alcohol (70% isopropyl alcohol)- Normal common disinfectant- Distilled/deionized water- Rubber gloves- 0.5 % Edisonite (to clean sampling system)- Cleaning brush- Cleaning solution (SysClean)- Cloths (clean, lint-free, absorbent)- Ultrasonic bath (if available; use only when the

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



10.210.210.210.210.2 Maintenance ScheduleMaintenance ScheduleMaintenance ScheduleMaintenance ScheduleMaintenance Schedule

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

DailyDailyDailyDailyDaily

None

Bi-weeklyBi-weeklyBi-weeklyBi-weeklyBi-weekly

Perform SYSTEM CLEANING INTENSIVEClean the microparticle mixerClean the sipper probeClean the S/R probePerform CELL CLEANING NORMAL

As requiredAs requiredAs requiredAs requiredAs required

Clean the analyzer surfaces and coverReplace printer paperClean the rinse stations

RD Service onlyRD Service onlyRD Service onlyRD Service onlyRD Service only

Perform CELL CLEANING INTENSIVE



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

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

3. When all requirements that are displayed onscreen have been fulfilled, press the START key.Elecsys 1010 starts the cleaning process anddisplays the time remaining until the cleaningprocess is complete. After half of the necessarytime of the cleaning process you have to emptythe waste container and clean it with distilledwater. Press PAUSE (at the bottom right of thescreen) to interrupt the cleaning process. Theprocess can be continued by pressing CONTINUE(same key).

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

10.310.310.310.310.3 Bi-weekly Analyzer MaintenanceBi-weekly Analyzer MaintenanceBi-weekly Analyzer MaintenanceBi-weekly Analyzer MaintenanceBi-weekly Analyzer Maintenance

10.3.110.3.110.3.110.3.110.3.1 Perform SYSTEM CLEANINGPerform SYSTEM CLEANINGPerform SYSTEM CLEANINGPerform SYSTEM CLEANINGPerform SYSTEM CLEANINGINTENSIVEINTENSIVEINTENSIVEINTENSIVEINTENSIVE

Perform the SYSTEM CLEANING INTENSIVE functionto prevent deposits and bacterial contamination. Theanalyzer displays a message when a maintenanceprocedure is required. This function should be performedon a bi-weekly basis.

NoteNoteNoteNoteNoteThe frequency with which the cleaning function isperformed is dependent on the test throughput and canbe set thus allowing longer maintenance intervals to bedefined.

Safety PrecautionsSafety PrecautionsSafety PrecautionsSafety PrecautionsSafety PrecautionsNone.

Materials NecessaryMaterials NecessaryMaterials NecessaryMaterials NecessaryMaterials NecessaryEdisonite.



10.3.310.3.310.3.310.3.310.3.3 Clean the Sipper ProbeClean the Sipper ProbeClean the Sipper ProbeClean the Sipper ProbeClean the Sipper Probe

Wipe the sipper probe clean every second week toremove any contamination.

Safety PrecautionsSafety PrecautionsSafety PrecautionsSafety PrecautionsSafety PrecautionsThe analyzer must be switched off. The sipper probe ispotentially biohazardous. Ensure that the normallaboratory safety precautions are heeded and wearrubber gloves.

Materials NecessaryMaterials NecessaryMaterials NecessaryMaterials NecessaryMaterials NecessaryAbsorbent, lint-free cloth and alcohol.

NoteNoteNoteNoteNoteWater droplets on the tip of the probe indicate possiblecontamination. This can affect the LLD function whichmay lead to analyzer problems.

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

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

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

CAUTIONCAUTIONCAUTIONCAUTIONCAUTIONHandle the sipper probe with care. Do not bend. A bentsipper probe can cause a run to stop as well as analyzererrors and incorrect results.

10.3.210.3.210.3.210.3.210.3.2 Clean the MicroparticleClean the MicroparticleClean the MicroparticleClean the MicroparticleClean the MicroparticleMixerMixerMixerMixerMixer

Wipe the microparticle mixer clean every second weekto remove any contamination. Do not bend themicroparticle mixer.

Safety PrecautionsSafety PrecautionsSafety PrecautionsSafety PrecautionsSafety PrecautionsThe analyzer must be switched off. Ensure that thenormal laboratory safety precautions are heeded andwear rubber gloves.


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

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

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

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



10.3.410.3.410.3.410.3.410.3.4 Clean the S/R ProbeClean the S/R ProbeClean the S/R ProbeClean the S/R ProbeClean the S/R Probe

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

Safety PrecautionsSafety PrecautionsSafety PrecautionsSafety PrecautionsSafety PrecautionsThe analyzer must be switched off. The S/R probe ispotentially biohazardous. Ensure that the normallaboratory safety precautions are heeded and wearrubber gloves.


NoteNoteNoteNoteNoteWater droplets on the tip of the probe indicate possiblecontamination. This can affect the LLD function (LiquidLevel Detection) which may lead to analyzer problems.

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

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

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

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



10.3.510.3.510.3.510.3.510.3.5 Perform CELL CLEANING NORMALPerform CELL CLEANING NORMALPerform CELL CLEANING NORMALPerform CELL CLEANING NORMALPerform CELL CLEANING NORMAL

Perform the CELL CLEANING NORMAL function everysecond week. CELL CLEANING NORMAL cleans thesipper flow path and measuring cell.

Safety PrecautionsSafety PrecautionsSafety PrecautionsSafety PrecautionsSafety PrecautionsEnsure that the normal laboratory safety precautionsare heeded and wear rubber gloves and protectionglasses.

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

1. Press the UTILITIES key and then theMAINTENANCE key. The MAINTENANCE, SYSTEMCLEANING screen is displayed.

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

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

4. Press the START key. Elecsys 1010 starts thecleaning process and displays the time remaininguntil the process is complete. Press PAUSE (at thebottom right of the screen) to interrupt the cleaningprocess. The process can be continued by pressingCONTINUE (same key).

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

CAUTIONCAUTIONCAUTIONCAUTIONCAUTIONIf the cell cleaning program is interrupted, e.g. instrumentcover opened, any fatal error, etc., a PRIME& RINSEhas to be started immediately to remove the ISE Cleaning

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



10.410.410.410.410.4 Maintenance, As RequiredMaintenance, As RequiredMaintenance, As RequiredMaintenance, As RequiredMaintenance, As Required

10.4.110.4.110.4.110.4.110.4.1 Clean the AnalyzerClean the AnalyzerClean the AnalyzerClean the AnalyzerClean the AnalyzerSurfaces and CoverSurfaces and CoverSurfaces and CoverSurfaces and CoverSurfaces and Cover

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

Safety PrecautionsSafety PrecautionsSafety PrecautionsSafety PrecautionsSafety PrecautionsThe analyzer must be in Stand-by mode. Ensure that thenormal laboratory safety precautions are followed andwear rubber gloves.

Materials NecessaryMaterials NecessaryMaterials NecessaryMaterials NecessaryMaterials NecessaryMaterials NecessaryPaper towels and lint-free cloths soaked in normaldisinfectant.

10.4.210.4.210.4.210.4.210.4.2 Replacing Printer PaperReplacing Printer PaperReplacing Printer PaperReplacing Printer PaperReplacing Printer Paper

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

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

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

3. Push the metal roller into the new paper roll andplace it back into position. The paper must be orientedso it feeds from the top of the roll.

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

5. Close the cover.

10.4.310.4.310.4.310.4.310.4.3 Clean the Rinse StationsClean the Rinse StationsClean the Rinse StationsClean the Rinse StationsClean the Rinse Stations

Clean all four rinse stations every two months to preventcontamination.

Safety PrecautionsSafety PrecautionsSafety PrecautionsSafety PrecautionsSafety PrecautionsThe analyzer must be switched off. Ensure that the normallaboratory safety precautions are followed and wear rubbergloves.

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

1. Unscrew (counter-clockwise) the knurled screws onall four rinse stations. Ensure that no liquid is spilledby 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. Refitthe clean rinse stations in the correspondingpositions and screw in tight.

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



10.510.510.510.510.5 Half-Yearly, Yearly, SpecialHalf-Yearly, Yearly, SpecialHalf-Yearly, Yearly, SpecialHalf-Yearly, Yearly, SpecialHalf-Yearly, Yearly, SpecialMaintenanceMaintenanceMaintenanceMaintenanceMaintenance

Service MaintenanceService MaintenanceService MaintenanceService MaintenanceService Maintenance

ycneuqerF ycneuqerF ycneuqerF ycneuqerF ycneuqerF erudecorP erudecorP erudecorP erudecorP erudecorP stnegreteD/lairetaMderiuqeR stnegreteD/lairetaMderiuqeR stnegreteD/lairetaMderiuqeR stnegreteD/lairetaMderiuqeR stnegreteD/lairetaMderiuqeR

ylraey-flaH stresnInoitatShsaWnaelC retaw,hsurBhtaBcinosartlUelbaliavafiro06.xam,zHK52ycneuqerF(

)C

EVISNETNIGNINAELCMETSYS L5.2,%5.0etinosidE1004255651:oN.dI

EVISNETNIGNINAELCLLEC Lm06noituloSgninaelCESI6130058921:oN.dI

:ecalpeR

sgnibuTpmuPetsaWsgnibuThcniP1DAV

5.1gnibuTR/SL0052egnirySregnulP

L052egnirySregnulPstresnInoitatShsaWfosgniR-O

retlifriA

0101EtiKecnanetniaM1001496091:oN.dI

knurT(yrassecenfI0101EteSgnibuT)kcots

1003396091:oN.dI

)yrassecenfiecalperdna(:kcehC

snoitatShsaWmorfsgnibutetsaW

ylraeY stresnInoitatShsaWnaelC retaw,hsurBhtaBcinosartlU,elbaliavafi,ro

06.xam,zHK52ycneuqerF()C



:ecalpeR

sgnibuTpmuPetsaWsgnibuThcniP1DAV

5.1gnibuTR/SL0052egnirySregnulPL052egnirySregnulP

stresnInoitatShsaWfosgniR-OretlifriA

retliFretaWlleCknaTreffuB

3ot1sgnibuTreppiSgnibuTrotcirtseR

0101EtiKecnanetniaM1001496091:oN.dI

lE.feR.wlleCgnirusaeM1003866071:oN.dI

8.0lleCgnibuT1008562081:oN.dI

)1(reppiSgnibuT1001362081:oN.dI

)2(reppiSgnibuT1000462081:oN.dI

metsyShsaWtCretliF1001356041:oN.dI

knaTreffuB1007135091:oN.dI

gnibuTrotcirtseR1005235091:oN.dI

0101EteSgnibuT1003396091:oN.dI

)yrassecenfiecalperdna(:kcehC

snoitatShsaWmorfsgnibutetsaW2.6,1.5,0.5,6.3,1.3,4.2,4.1sgnibuT

R/SeborPreppiSeborP

reximdaeB

1-01e



Half- Yearly MaintenanceHalf- Yearly MaintenanceHalf- Yearly MaintenanceHalf- Yearly MaintenanceHalf- Yearly Maintenance

ProcedureProcedureProcedureProcedureProcedure

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

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

CELL CLEANING INTENSIVECELL CLEANING INTENSIVECELL CLEANING INTENSIVECELL CLEANING INTENSIVECELL CLEANING INTENSIVE

Fill the System Water Container with deionized water,empty the waste container. Put a ProCell containerwhich is filled with 60 ml ISE Cleaning Solution onposition 2 of the System, Reagent compartment.Activate the function CELL CLEANING INTENSIVE.Afterwards remove the S/R Rotor as well as WashStation Inserts, Cover Inside (362), MFA HousingInsert(366), Instrument Housing Top (360) and theFront Panel(369). Refer to chapter 4.1.1 of the ServiceManual.

TubingsTubingsTubingsTubingsTubings

Replace the Waste Pump Tubings, the Pinch Tubingsand the S/R Tubing 1.5. Check the Waste Tubings(coming from the Wash Stations) and replace them incase of any visible contamination.

SyringesSyringesSyringesSyringesSyringes

Replace the plungers of the S/R Syringe and the SipperSyringe.

AirfiltersAirfiltersAirfiltersAirfiltersAirfilters

Replace the Airfilter Inserts.

Wash StationsWash StationsWash StationsWash StationsWash Stations

Clean the Wash Station Inserts with water using a softbrush. Check, if there are any particles inside the jetsand remove them if necessary. Afterwards the O-ringsof the Wash Station Inserts are to be replaced.

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

Final Checks and CalibrationsFinal Checks and CalibrationsFinal Checks and CalibrationsFinal Checks and CalibrationsFinal Checks and Calibrations

Check mechanical adjustments as well as pump volumeadjustments (Service Software). Run a CELL CHECKand edit the existing Kosigkal.csv-file accordingly. Alltest assays are to be calibrated after the maintenance!Run at least 3 different test parameters and check thecalibration results as well as the precision.



Yearly MaintenanceYearly MaintenanceYearly MaintenanceYearly MaintenanceYearly Maintenance


Follow the procedure Half-Yearly Maintenance. It isrecommended to replace the following parts in addition(to be ordered seperately).

Water Supply SystemWater Supply SystemWater Supply SystemWater Supply SystemWater Supply System

Replace the Buffer Tank as well as the Water Filter(called CT-wash filter).

CellCellCellCellCell

Replace the Cell incl. Reference Electrode, Cell Tubing0.8, Tubing Sipper (1), Tubing Sipper (2), as well as theRestrictor Tubing (between VM1 and waste tubing).Even though the Cell is replaced completely, the CELLCLEANING 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 PrepareImportant! It is essential that at least 30 PrepareImportant! It is essential that at least 30 PrepareImportant! It is essential that at least 30 PrepareCycles are performed before the system isCycles are performed before the system isCycles are performed before the system isCycles are performed before the system isCycles are performed before the system iscalibrated! Start the Service Software and activatecalibrated! Start the Service Software and activatecalibrated! Start the Service Software and activatecalibrated! Start the Service Software and activatecalibrated! Start the Service Software and activatethe 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 Systemm. cycles. Since the volume of the Sipper Systemm. cycles. Since the volume of the Sipper Systemm. cycles. Since the volume of the Sipper Systemhas changed after the replacement of the Cell andhas changed after the replacement of the Cell andhas changed after the replacement of the Cell andhas changed after the replacement of the Cell andhas changed after the replacement of the Cell andthe Sipper Tubings, it is important that SYSTEMthe Sipper Tubings, it is important that SYSTEMthe Sipper Tubings, it is important that SYSTEMthe Sipper Tubings, it is important that SYSTEMthe Sipper Tubings, it is important that SYSTEMVOLUME CHECK is done before the instrument isVOLUME CHECK is done before the instrument isVOLUME CHECK is done before the instrument isVOLUME CHECK is done before the instrument isVOLUME CHECK is done before the instrument isused.used.used.used.used.

Final Checks and calibrationsFinal Checks and calibrationsFinal Checks and calibrationsFinal Checks and calibrationsFinal Checks and calibrations

Check mechanical adjustments as well as pump volumeadjustments (Service Software). Run a CELL CHECKand edit the existing Kosigkal.csv-file accordingly. Alltest assays are to be calibrated after the maintenance!Run at least 3 different test parameters and check thecalibration results as well as the precision.



Service MaintenanceService MaintenanceService MaintenanceService MaintenanceService Maintenance

ycneuqerF ycneuqerF ycneuqerF ycneuqerF ycneuqerF erudecorP erudecorP erudecorP erudecorP erudecorP stnegreteD/lairetaMderiuqeR stnegreteD/lairetaMderiuqeR stnegreteD/lairetaMderiuqeR stnegreteD/lairetaMderiuqeR stnegreteD/lairetaMderiuqeR

lairetcablaitnetopfoesacnI.ylnonoitanimatnoc



:ecalpeR

knaTreffuBretliFretaW

:ylppuSretaWsgnibuT ,7.3,2.6,1.5,0.5 ,6.3,1.3,4.2,4.1,1.1 R/SrotuliDgnibuT 5.1R/SgnibuT

1SWylppuSretaWsgnibuT eceiP-Ydna5.3,4.3,3.3,2.3

1BWylppuSretaWsgnibuT eceiP-Ydna,21.3,11.3,01.3

1DWylppuSretaWsgnibuT eceiP-Ydna,61.3,51.3,8.3

2DWylppuSretaWsgnibuT eceiP-Ydna,41.3,31.3,9.3

0101EteSgnibuT1003396091:oN.dI

metsyShsaWtCretliF1001356041:oN.dI

knaTreffuB1007135091:oN.dI

5.1R/SgnibuT1006662081:oN.dI

R/SrotuliDgnibuT1006796091:oN.dI

stresnInoitatShsaWnaelC noituloS2O2H,hsurB)edixoreP(

htaBcinosartlUelbaliavafiro06.xam,zHK52ycneuqerF(

)C

EVISNETNIGNINAELCMETSYS)noituloS2O2H%3htiw(

retaWdezinoiedhtiwpetsdn2

noituloS2O2H%3L2)edixoreP(

)relaeDlacol(

2-01e

Attention:Attention:Attention:Attention:Attention:

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!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!



Special MaintenanceSpecial MaintenanceSpecial MaintenanceSpecial MaintenanceSpecial Maintenance


All tubings which will be replaced during SpecialMaintenance 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 CELLCLEANING INTENSIVE should be activated prior to thereplacement of parts: Switch the instrument on andactivate SYSTEM CLEANING INTENSIVE. For part 1of this cleaning program, fill the System Water Containerwith at least 2.5 L of 0.5% Edisonite Solution.

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

CELL CLEANING INTENSIVECELL CLEANING INTENSIVECELL CLEANING INTENSIVECELL CLEANING INTENSIVECELL CLEANING INTENSIVE

Fill the System Water Container with deionized water,empty the waste container. Put a ProCell containerwhich is filled with 60 mL ISE Cleaning Solution onposition 2 of the System Reagent compartement.

Activate the function CELL CLEANING INTENSIVE.

Afterwards remove the S/R Rotor as well as WashStation Inserts, Cover Inside (362), MFA HousingInsert(366), Instrument Housing Top (360) and theFront Panel(369). Refer to chapter 4.1.1 of the ServiceManual.

Water Supply SystemWater Supply SystemWater Supply SystemWater Supply SystemWater Supply System

Basically all tubings of the Water Supply System are tobe replaced (see table above). In addition the tubingsTubing S/R 1.5 and Tubing Dilutor S/R should bereplaced as well.

Buffer TankBuffer TankBuffer TankBuffer TankBuffer Tank

Replace the Buffer Tank as well as the Water Filter(called CT-wash filter).

Wash Station InsertsWash Station InsertsWash Station InsertsWash Station InsertsWash Station Inserts

Clean the Wash Station Inserts with 3% Peroxide3% Peroxide3% Peroxide3% Peroxide3% Peroxidesolution using a soft brush. Check, if there are anyparticles inside the jets and remove them if necessary.

After the reassemblyAfter the reassemblyAfter the reassemblyAfter the reassemblyAfter the reassembly

Switch the instrument on and activate SYSTEMCLEANING INTENSIVE. For part 1 of this cleaningprogram, fill the System Water Container with at least 2 Lof 3% Peroxide3% Peroxide3% Peroxide3% Peroxide3% Peroxide Solution.

As soon as part 1 is finished, rinse the System WaterContainer with deionized water, fill it with deionizedwater, put it back to the instrument and activate part 2 ofthe cleaning program (press the START button).

Final Checks and calibrationsFinal Checks and calibrationsFinal Checks and calibrationsFinal Checks and calibrationsFinal Checks and calibrations

Check mechanical adjustments as well as pump volumeadjustments (Service Software). Run a CELL CHECKand edit the existing Kosigkal.csv-file accordingly. Alltest assays are to be calibrated after the SpecialMaintenance! Run at least 3 different test parametersand check the calibration results as well as theprecision.

Note:Note:Note:Note:Note:

If one of the cell cleaning programs (CELLIf one of the cell cleaning programs (CELLIf one of the cell cleaning programs (CELLIf one of the cell cleaning programs (CELLIf one of the cell cleaning programs (CELLCLEANING NORMAL or CELL CLEANINGCLEANING NORMAL or CELL CLEANINGCLEANING NORMAL or CELL CLEANINGCLEANING NORMAL or CELL CLEANINGCLEANING NORMAL or CELL CLEANINGINTENSIVE) is interrupted, e.g. instrumentINTENSIVE) is interrupted, e.g. instrume

frankshospitalworkshop.comtranslate this...

Documents