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Urisys 1100®

Operator’s Manual

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Last update:2012-12

The packaging material, the identification plate on the instrument and the manual may contain the following symbols or abbreviations:

Please consult instructions for use

! Caution (refer to accompanying documents).

Please refer to safety-related notes in the manual accompanying this instrument.

Store at

Manufacturer

REF Catalog number

IVD For in vitro diagnostic use

This product fulfils the requirements of Directive98/79/EConinvitrodiagnostic medical devices.

COBAS,LIFENEEDSANSWERS,URISYSandCHEMSTRIParetrademarksofRoche.©2012RocheDiagnostics.Allrightsreserved.REF03617599001

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Operator’s Manual V04

Table of Contents Page

1. Introduction 1

2. SystemDescription 2

2.1 MeasuringPrinciple 2

2.2 ComponentsandFunctions 3

3. Software 3

3.1 Overview 3

3.2 MenuStructure(Flowchart) 4

3.3 MenuFunctions 6

3.4 DefaultSettings 7

3.5 ResultsTable 8

4. Installation 9

4.1 Unpacking 9

4.2 InstallationandPower-OnProcedure 10

4.3 ModificationforChemstrip®5OBandChemstrip®7UrineTestStrips 12

4.4 OperatorID 12

4.5 Authentication 12

5. Calibration 13

6. ReadingTestStrips 14

6.1 InstrumentOverview 14

6.2 QualityControlRecommendations 14

6.3 RoutineUrineTesting 15

6.4 PatientReport 16

6.5 StripMeasurementError 17

6.6 EnteringPatientID 17

6.7 DataTransmissiontoaPCorHostComputer 18

7. CleaningandMaintenance 19

7.1 RoutineCleaning 19

7.2 DailyMaintenance 19

8. ErrorMessagesandTroubleshooting 20

9. ConnectingtoOtherDevices 22

9.1 SerialInterface 22

9.2 BarcodeReader,AT/PCKeyboard 23

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10. TechnicalInformationandNotices 24

10.1 InstrumentSpecifications 24

10.2 SafetyNotices 25

10.3 Warranty 25

11. OrderingInformationandReplacementParts 26

12. ContactInformation 27

Table of Contents Page

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1Operator’s Manual V04

1. IntroductionManual version Software version Revision date Amendments04 6.x December2012 Minor revision of text.

Operator ID, limited lock-out function, Device ID, compatibility of barcode reader, ASTM protocol

The Urisys 1100®UrineAnalyzer(Cat.No.03617556001)isareflectancephotometerdesignedtoautomaticallyreadandevaluate the results of Chemstrip®10MD*,Chemstrip®7andChemstrip®5OBTestStripsfromRocheDiagnostics.Itreadsthe strips under standard ized conditions, saves the results to memory, and outputs them via its internal printer and/or serial interface.

Using the Urisys 1100® Urine Analyzer eliminates factors known to affect visual evaluation of urine test strips, such as:

• Variable lighting conditions at the workplace • Individual skill levels at matching test strip pad colors • Different reaction times for the test strips • Clerical errors • Strong color of the urine sample

To perform a urinalysis test, simply dip the test strip in the urine sample, gently press the long edge of the test strip to a piece of absorbent paper for one second, and place it in the test strip tray with the pads facing upward. Then press the STARTbutton.Measurementiscompletein70seconds,andresultsareautomaticallyprinted.

The following symbol is used throughout this document.

WARNING/CAUTION: Indicates a potentially hazardous situation that, if not avoided, ! could result in personal injury or damage to the instrument. This symbol is also used to highlight situations that can compromise results.

RocheDiagnosticsprovides24-hour,7-days-a-week,365-days-per-yeartechnicalsupport.Ifyouhaveanyquestionsorneedassistance,pleasecontactRocheTechnicalServiceat1-800-428-4674.

*HospitalsmayuseChemstrip10UAUrineTestStrips(Cat.No.11895354160).

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2 Operator’sManualV04

2. SystemDescription2.1 MeasuringPrinciple

The test strip is placed on a sliding tray, and a stepping motor moves it under the reading head, which remains stationary. The ana lyzer reads the reference pad, followed by each of the test pads on the strip.

ThereadingheadcontainsLEDsthatemitlightatvariouswavelengths.Readingisdoneelectro-optically,asfollows:

Detector(3)Microprocessor(5)

A/DConverter(4)

LED(1)

Result(6)

TestPad(2)

TheLED(1)emitslightofadefinedwavelengthontothesurfaceofthetestpad(2)atanoptimumangle.Thelighthittingthe test zone is reflected proportional to the color produced on the test pad, and is picked up by the detector, a photo-transistor(3)positioneddirectlyabovethetestzone.ThephototransistorsendsananalogueelectricalsignaltoanA/Dconverter(4),whichchangesittodigitalform.Themicroprocessor(5)thenconvertsthisdigitalreadingtoarelativereflectance value by referring it to a calibration standard.

Finally, the system compares the reflectance value with the defined range limits (reflectance values that are programmed intotheanalyzerforeachparameter)andoutputsasemi-quantitativeresult(6).

Eachtestpadisreadphotometricallyafterabout55–65seconds.Instronglyalkalineurinesamples,theUrisys 1100® Urine Analyzer automatically corrects the result of the specific gravity test.

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2.2 ComponentsandFunctions

Component Function1.Printercover Flipsupforinsertionofprinterpaper Program Chip Contains software needed to operate the analyzer and interpret results

(under printer cover)2.Display/keypad LCDdisplayandthreefunctionkeysformenu-drivenoperationandinterfacingwith

the user 3.Teststriptray Holdsandanchorsthestrip4.STARTbutton a)Startsthereadingprocess b) Closes submenus and returns to the starting menu (Ready-to-Measure status) 5.On/Offswitch Powerstheunitonandoff6.Serialinterface Forconnectiontoapersonalorhostcomputer7.Powersocket SocketusedtoconnecttheanalyzertotheACadaptor8.5-pinDINsocket ForconnectingabarcodereaderorAT/PCkeyboard

3. Software3.1 Overview

The Urisys 1100® Urine Analyzer software provides a user interface that enables specific settings and recurrent functions to beselectedviatheliquidcrystaldisplay(LCD)andfunctionkeys(seeSections3.2and3.3).

The three function keys correspond to the particular function displayed on the second line of the LCD. The first line of the display is used for system status and user information.

The user interface is designed to be self-explanatory, therefore only details of the major functions are presented here.

PressingtheSTARTbuttonwithinanysubmenuselectsthedesignatedinstrumentstateorfunction,andreturnsthesystemtoReady-to-Measurestatus.

The instrument switches from the Ready-to-Measure status or displayed status, respectively, to the Standby mode after five minutes of function key inactivity. During Standby, the date and time are displayed. Ready-to-Measure status can be resumedbypressingtheSTARTbutton,exceptwhencertainerrormessagesaredisplayed(seeSection8).

1

2

3

4

8765

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3.2 MenuStructure(Flowchart)

The flowchart below provides a visual display of the menu structure and how to access the various instrument settings and functions.

PressingtheSTARTbuttonconfirmsthesetting,closesthesubmenu,andresumesReady-to-Measurestatus.

SELF CHECK

No.: … Insert strip!Calibr. Linefeed Menu

PRINT RESULTSAll Last Ser. Last one

LINEFEEDStop

MENUMemory New Ser. Setup1

START CALIBRATION!Press Start Button!

PRINTINGStop

MEMORYPrint Send Clear

CLEAR MEMORY ?Yes No

SEND RESULTSAll Last Ser. Last one

PRINT STOPPEDLinefeed Continue Home

SETUP1Modes Strip Setup2

MODESPrinter Interf.

PRINTER: ON(1 Copy)On 2(Copies) Off

SENDING RESULTS

INTERFACE: UNIDIRUnidir. Bidir ASTM

See next page

OpID=OFF

Ready-to-Measure Status

SW 6.x (US Version)

AUTH=OFF

Operator: …….Enter new OpID!

Password:Enter password!

Password=O.K.

OpID=ON

AUTH=ON

AUTO PAT.ID: ONSeq.No. Auto.Pat. OFF

INTERFACE BIDIR 10 Bidir 10 Bidir 13

LINENext + Baudrate -

BaudrateLengthParityStopbits

1/1

_1_UX3USA1mit OPID.vsd

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MenuStructure(continued)


STRIP SETTINGSType Units

SETUP3Language Device ID Op.ID

STRIP TYPE:CHEMSTRIP10 CHEM10 CHEM7 CHEM5

DD.MM.YYYY hh:mm<<<< + -

SETUP2Date/Time Setup3

UNITS: CONVENTIONALConv. SI Arb.

DD.MM.YYYY hh:mmSequence 12/24 Set

OPERATOR ID: AUTH.Download list Log*

LANGUAGE: ENGLISHOther

LOGDATAPrint (last 20) Send

PRINTINGStop

SENDING

OPERATOR ID: ON On Auth. Off

SETUP1Modes Strip Setup2

*Only by supervisors in Authentication Mode

SW 6.x (US Version)

1/1

_2_UX3USA2.vsd

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3.3 MenuFunctions

SelfCheck:During Self Check at power-on, the analyzer automatically checks that the program chip, tray transport mechanism, printer connection and optical system are all operating properly. The tray type is checked (seeSections4and7.1)toensurethatitcorrectlymatchestheteststriptypeselectedinthemenu.

Calibration: ForrequestingcalibrationwithChemstripCalibrationStrip(seeSection5).

Linefeed: Causespapertoadvance.Thelinefeedisstoppedbypressingtheleftfunctionkey(“Stop”)(seeSection4).

NewSeries:Forstartinganewseriesofmeasurementsatsequencenumber1.ItisalsopossibletohaveanAutomaticPatientID(seeSection6.1).

Memory:Theanalyzercanstoreupto100resultstogetherwithdateandtimeofmeasurement,sequencenumberandpatient ID (if entered). Memory is automatically cleared every time the date changes.

Aftermemoryhasbeenerased,“NORESULTSSTORED”isdisplayedwhen“Memory”ispressed.PressingtheSTARTbuttonresumesReady-to-Measurestatus.“MEMORYFULL”andtheoptions“Print/Send/Clear”aredisplayedwhenthememory is full. Memory must be cleared before the analyzer can resume Ready-to-Measure status.

PrintResults: For generating a printout of stored results. The options are as follows: • All: All results in memory (i.e. for current date) • Last Series: The most recent series of readings • Last one: The most recent reading

Printing can be repeated as often as desired. Printing can be interrupted by pressing the left key (“Stop”), for example to allow a new roll of printer paper to be inserted (“Linefeed”), and subsequently resumed (“Continue”). The analyzer resumes Ready-to-Measure status when the “Home” key is pressed or when printing has finished.

Send Results: For sending stored results to the serial interface. Options are the same as for “Print Results“. Results can be sentasoftenasrequired(SeeSections6.7and9.1).

ClearMemory:Erasesresultsfrommemory.

Mode:Choice of Printand Interface modes.

Printer:Printer options are:• On:Theprinterisswitchedon.Eachresultisprintedonce.• 2Copies:Eachresultisprintedtwice.Note:Whentheprintoutisarepeatprintout(activatedbythePrintResults

function), each result is printed only once. • Off: For switching off the printer when the printout of results is only required at the end of a series of readings

(activated by the “Print Results” function), or when results are only to be sent via the interface to a personal or host computer.

Interface: Choice of unidirectional, bidirectional or ASTMdatatransfer.Forfurtherdetails,seeSections6.7and9.

Logdata:ChoiceofsendingthelogfilestothehostPCorprintingoutthelast10loggeddata.(OnlybysupervisorsinAuthentication mode)

Strip Settings: For selecting test strip type and units.

Strip Type: Choice of test strip type:• Chemstrip10MD*TestStrip(CHEM10) • Chemstrip5OBTestStrip(CHEM5)• Chemstrip7TestStrip(CHEM7)The Urisys 1100® Urine Analyzer leaves the factory configured for Chemstrip10MDTestStrips.IfyouintendtouseChemstrip5OBorChemstrip7TestStrips,youwillneedtousetheappropriateteststriptray(seeSections4.3and11).

*HospitalsmayuseChemstrip10UAUrineTestStrips(Cat.No.11895354160).

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Units: Options are:• Conventional units (mg/dL) • SI units (mmol/L) • Arbitrary units (+, ++, +++, ++++)

The operator selects the units in which the results are to be stored, printed and/or transferred to a computer. After a new unit setting has been selected, the repeat printout (activated by “Print Results”) and all following printouts and/or data transfer (activated by “Send Results”) will be in the newly chosen units.

Language: Thisenablesthedisplaylanguagetobeset.The“Other”optionallowstheoperatortochoosebetweenEnglish, German, Italian, Spanish and French.

Device ID: Displaysthe5digitsdeviceID,whichispartofthefactorysettingsandcannotbechanged.The device ID will also be sent to the host.

Operator ID:ChoicebetweenNormalandAuthenticationmodesfortheoperatoridentification.Ifactivatedtheinputofanoperator ID will be required by the start of the instrument.

The Operator ID will appear in the result printout and will also be sent to the host PC. Authentication mode offers a lock-out functionandrequirestheASTMprotocol.(referSection4.2and6.6fordetails.)

DATE/TIME: For setting the date and time.

ThefactorydefaultisthedateinMonth-Day-Yearorderandthetimeinhours(12-hourclock)andminutes.Ifrequired,thetimecanbedisplayedinthe“24-hourclock”mode.Pressingthe“Sequence”keyallowsthedateformattobechangedtoDay-Month-Year or Year-Month-Day. “Set” causes the date and time to be displayed and set. Pressing the left function key (<<<) moves the blinking cursor to the left. The time or date unit highlighted by the cursor can then be increased or decreased by pressing the + / — keys.


3.4 DefaultSettings

TheUrisys1100® Urine Analyzer comes equipped with the following default settings. These can be changed using the functionkeystopagethroughthemenusandtheSTARTbuttontoactivatethenewsettingsselection.(SeeSections3.2and3.3.)

Parameter Default Setting Optional Setting

Print results Printer On, (one copy) Printer On (two copies)Printer Off

Interface mode Uni-directional Bi-directionalOperator ID Off On / Authentication Mode (ASTM)Language English German, Italian, Spanish, FrenchDate/time format Date: Month-Day-Year

Time:12-hourclockDate: Day-Month-Year / Year-Month-DayTime:24-hourclock

Reporting Unit Conventional units SI units or Arbitrary UnitsTest Strip Type Chemstrip10 Chemstrip5OB

Chemstrip7

Followtheflowchartinsection3.2todeterminethemenupathwaytoaparticularsetting.UsethefunctionkeysandtheSTART button to access and change the setting.

PleaseContactRocheTechnicalServiceat1-800-428-4674ifyouneedassistance.

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3.5 ResultsTable

Urine test strip measurement values can be reported in either conventional units, SI units, or arbitrary units. The following table lists the levels of concentration that are reported for each format.

Parameter Conv. SI ArbitrarySpecificGravity(SG) 1.000 1.000 1.000 1.005 1.005 1.005 1.010 1.010 1.010 1.015 1.015 1.015 1.020 1.020 1.020 1.025 1.025 1.025 1.030 1.030 1.030pH 5 5 5 6 6 6 6.5 6.5 6.5 7 7 7 8 8 8 9 9 9LEU(Leukocytes) neg neg neg 25Leu/µL 25Leu/µL TR 75Leu/µL 75Leu/µL + 500Leu/µL 500Leu/µL ++NIT(Nitrite) neg neg neg pos pos + (pos)PRO neg neg neg (Protein) TR TR TR 30mg/dL 0.30g/L + 100mg/dL 1.00g/L ++ 500mg/dL 5.00g/L +++GLU norm norm norm (Glucose) 50mg/dL 3mmol/L TR 100mg/dL 6mmol/L + 250mg/dL 14mmol/L ++ >1000mg/dL >56mmol/L +++KET neg neg neg (Ketone) 15mg/dL 1.5mmol/L + 50mg/dL 5mmol/L ++ 150mg/dL 15mmol/L +++UBG norm norm norm (Urobilinogen) 1mg/dL 17µmol/L + 4mg/dL 68µmol/L ++ 8mg/dL 135µmol/L +++ >12mg/dL >203µmol/L ++++BIL neg neg neg (Bilirubin) 1mg/dL 17µmol/L + 3mg/dL 50µmol/L ++ 6mg/dL 100µmol/L +++BLD neg neg neg (Erythrocytes) TR TR TR 50Ery/µL 50Ery/µL + 250Ery/µL 250Ery/µL ++

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4. Installation

! PleasereadtheUrisys 1100®UrineAnalyzerOperator’sManualcarefullybeforeinstallation,toensure

proper operation of the analyzer.

4.1 Unpacking

Carefully remove the contents of the Urisys 1100® Urine Analyzer box and check for the following items:

Contents: 1. Urisys 1100® Urine Analyzer 2. ACadaptor(100V-240V,50/60Hz)3. Power cord 4. Roll of printer paper 5. Test strip tray, Type C, for reading Chemstrip®10MDTestStrips6. Teststriptray,TypeN,forreadingChemstrip®5OBandChemstrip®7TestStrips

Items included, but not pictured: • Operator’s Manual including Policies and Procedures CD• User Training CD • QuickReferenceGuide• WarrantyCard

1

4

52

6

3

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4.2 InstallationandPower-onProcedure

Set-Up(1) PlacetheUrisys 1100® Urine Analyzer on a stable, level surface. To ensure accurate readings, please take the following

environmental precautions:

! • Do not set the analyzer in close proximity to devices that create high-frequency fields, as they may interfere and

produce false results. Such devices include; walkie-talkies, mobile telephones, microwave ovens and diathermic equipment.

• Do not expose the analyzer to direct sunlight or strong artificial light.• If the analyzer has been exposed to significant changes in temperature and/or humidity, allow it to sit at room

temperature for at least four hours before operating.

(2) ConnectthePowercordandACadaptor.ThenconnecttheACadaptortothepowersocketattherearoftheinstrument. Plug the power cord into a readily accessible AC power outlet.

Insertion of Test Strip Tray (3) Selecttheappropriateteststriptray.UseTypeCtoreadChemstrip10MD

UrineTestStrips.UseTypeNtoreadeitherChemstrip5OBorChemstrip7Urine Test Strips. The type of tray is indicated on the underside of the tray. SeeSection4.3fordetailsonusingtheUrisys1100® Urine Analyzer with Chemstrip5OBorChemstrip7UrineTestStrips.

Hold the test strip tray with the gray reference pad facing up and towards theanalyzer(seeFigure1).Slidetheteststriptrayintotheslotbelowthefunctionkeysuntiltheretainingbarcloses(seeFigure2).

! Becarefulnottotouchthegrayreferencepad.Contaminationofthereferencepadmayimpairthequality

of the results obtained.

Figure1

Figure2

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PaperInstallation(4) Releasetheprinterpapercoverbypressingtheareaimmediatelybelowand

totherightoftheprinterpaperslot(seeFigure3).Thecovercanthenbelifted back. Place the paper roll in the compartment and pull out the first few inches of paper to just beyond the edge of the compartment. The thermosensitive side of the paper (the outer surface of the paper roll) should befacingdownwards(seeFigure4).Closethecoveragainbypressinguntilit locks audibly into position.

SelfCheck (5) SwitchontheUrisys1100® Urine Analyzer using the on/off switch at the

rear of the instrument. The analyzer will then automatically perform a self check. The analyzer is factory set to read Chemstrip10MDteststrips.Itchecks that the correct tray has been inserted. On completion of the self check, the tray returns to the start position and the retaining bar opens (see Figure5).Iftheselfcheckiscompletedsucessfully,themessage“SelfCheck OK” will print along with the time and date.

ATTENTION: IfthemessageE9WrongTray!isdisplayedaftertheUrisys 1100® Urine Analyzer is switched on, press the STARTbutton.TheselectionmenuSTRIPTYPEisdisplayed.IfyouusetheChemstrip10MDTestStrips,selectCHEM10bypress ing the left function key. If you use Chemstrip5OBorChemstrip7TestStrips,selectCHEM5orCHEM7respectively,by pressing the corresponding function keys.

Calibration (6) Uponfirstuseoftheanalyzer,themessage“REPEATCALIBRATION”appearsafterasuccessfulselfcheck.This also

happens if the analyzer is not used for more than seven days. Calibration must be performed using a Chemstrip CalibrationStrippriortoreadingpatientsampleswhenusingtheChemstrip10MDTestStrip.SeeSection5fordetailson this calibration procedure.

ATTENTION: If Chemstrip5OBorChemstrip7TestStripsareused,calibrationisnotnecessarywiththeChemstripCalibration Strips. The instrument calibration is performed automatically via the gray reference field on the test strip tray.

ModifyingSettings(7) TheUrisys1100® Urine Analyzer leaves the factory with default settings for Printer Results, Interface Mode, Test Strip

Type,ReportingUnits,Language,Date/timeformat(seeSection3.4)andOperatorID.Individualfacilitypreferencescanbeenteredviathemenus.SeeSection3fordetailsonmodifyinginstrumentsettingsthroughthesoftwaremenus.

Figure3

Figure4

Figure5

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4.3 ModificationforChemstrip5OBandChemstrip7UrineTestStrips

For readings with Chemstrip5OBorChemstrip7TestStrips,theTypeNteststriptrayisrequiredtoaccomodatetheshorterteststrips.Itisnecessarytomodifythe“striptype”settingontheanalyzertoeither“Chem7”or“Chem5”asappropriate.Todothis,pressSTARTandusethefunctionkeystoselect“Menu”,followedby“Setup1”,“Strip”,andthen“Type”.Selecttheappropriatestriptypefromthemenu.PressSTARTtoconfirmandtheninserttheTypeNteststriptrayintothereader.TheUrisys1100® Urine Analyzer is now ready.

ForChemstrip5OBandChemstrip7UrineTestStrips,calibrationwiththeChemstripCalibrationStripisnotnecessary. The instrument calibration is performed via the gray reference pad on the test strip tray.

PleasenotethattheChemstrip5OBandChemstrip7UrineTestStripsdonothaveacompensationpad.Consequently,whenusedwitheitherofthesestrips,theUrisys1100® Urine Analyzer does not compensate for strong intrinsic urine coloration and occasional false-positive readings may occur.

4.4OperatorID

TheUrisys1100®softwareallowstheactivation/deactivationoftheoperatoridentificationcode,containingupto12alphanumericcharacters.TheOperatorIDandAuthenticationmodecanbeactivatedinSetup3.

NOTE: Please ensure that you have a barcode reader and/or an AT/PC keyboard prior to activation, as you will need one for this function.

NormalIf activated, the operator ID is asked upon every restart of the system and coming out from sleep mode. ThisoperatorIDcancontainupto12alphanumericcharactersandwillbeprintedouttogetherwiththetestresultsandwill be sent to the host.

4.5Authentication

Itispossibletodownloadupto300operatorIDswithcorrespondingpasswords(upto12alphanumericcharacters)fromthe host PC via the ASTM protocol.

DevicecanbeusedonlybyanoperatorwithIDandpasswordinthedownloadedlist.EntryofincorrectoperatorIDandpasswords causes a lock out. This prevents access of the instrument by unauthorized users.

Operatorshavingsupervisorrights(maximum2)haveaccesstoallresults,maysendtheinstrumentlogfiletothehostorprintthelast10actionsofthelogfileandmaydeactivatetheauthenticationmode.

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5. CalibrationThefollowingsectiononlyapplieswhentheUrisys 1100® Urine AnalyzerisusedwithChemstrip10MDTestStrips.WhenusingChemstrip5OBorChemstrip7TestStrips,thecalibrationproceduredescribedbelowisnotnecessary(seeSection4.3).

OverviewThe Urisys 1100®UrineAnalyzeriscalibratedbeforeleavingthefactory.Wheninstalled,itmustberecalibratedwithaChemstrip Calibration Strip before the first samples are read, and thereafter every seven days. Chemstrip Calibration Strips consist of a gray plastic material that is standardized to give constant, defined reflectance readings. Calibration strips should remain in the vial until just prior to use and should only be used once.

The purpose of calibrating the analyzer is to compensate for aging effects that influence the optical system and the gray reference pad in the strip tray. If the compensation needed is excessive, for example because the reference pad is badly soiled,oranLEDisdefectiveandcannotemittherequiredamountoflight,anerrormessageisdisplayed(seesectionbelow on calibration errors).

WhentheUrisys 1100® Urine Analyzer is set to read Chemstrip10MDTestStrips,itautomaticallyrequestsanewcalibrationeveryweek.Inaddition,whentheinstrumentisinstalled,the“REPEATCALIBRATION!”messageisdisplayedfollowing a successful self check.

Procedure1.Makesurethattheteststriptrayiscleananddry.

2.Ifthemessage,“REPEATCALIBRATION”isonthedisplay,presstheSTARTbutton. If the analyzer is in the Ready-to-Measure mode, use the left function keytoselect“Calibr.”.Next,the“STARTCALIBRATION”messageisdisplayed.

3.RemoveacalibrationstripfromtheChemstripCalibrationStripcontainer.Becareful not to touch the pads and do not allow them to come into contact with urine.

4.Placethecalibrationstrip,withthetestpadsfacingupwards,onthetraysothat its leading edge is held by the clip at the end of the test strips tray. The retaining bar must be open(seeFigures6and7).Beforecalibrating,ensure that the tray is clean and dry.

ATTENTION: It is very important that the calibration test strip locks into the instrument correctly in order to ensure the quality of the calibration.

5.PresstheSTARTbutton.Thedisplaywillthenread,“Heatup!Pleasewait,xxsec left.” Once the countdown is finished, the measurement begins. If calibrationresultsareacceptable,themessage“CALIBRATIONO.K.”isdisplayed and results are printed.

6.Thetraythenreturnstothestartposition,andtheretainingbaropens.Removeanddisposeofthecalibrationstrip.Useeach calibration strip only once.

! Regular calibration is necessary to ensure the quality of the results obtained. Roche Diagnostics cannot

warranttheaccuracyofresultsifthesystemisnotcalibratedregularly.

Figure6

Figure7

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Calibration printout If the new calibration results are within the acceptable range, the message

“CALIBRATIONO.K.”isdisplayed.Resultsarestoredinmemoryandautomatically printed along with time and date. A list of reflectance values for measuringpositions1–11fortheorangeLEDareprintedinthemiddlecolumnandforthegreenLEDintherightcolumn.(SeeFigure8).

Calibration errors If the results obtained for the reference pad or the calibration strip are outside the programmed tolerances, one of the followingmessageswillappear:“REFERENCEPADERROR!”,“CALIBRATIONINVALID!”or“CALIBRATIONERROR!”.

In the event of a calibration error, repeat the calibration procedure with a fresh Chemstrip Calibration Strip. Press the START buttontoreturntothe“STARTCALIBRATION”menu.Followthesamecalibrationprocedureasabove.Whenthemessage“CALIBRATIONO.K.”hasbeenprinted,proceedwiththereadingofteststrips.Ifyoucontinuetoreceiveanerrormessage,seeSection8.

6. ReadingTestStrips6.1 InstrumentOverview

The Urisys 1100® Urine Analyzer is very easy to use. Simply insert the test strip when the display reads “Insert Strip”, then press the START button. The analyzer automatically waits for the strip to incubate before it reads the first test pad. Seventy seconds after the START button is pressed, the measurement is completed and the test strip tray returns to the start position.Throughputisapproximately50teststripsperhour. Eachtimeateststripisread,thegrayreferencepadinthetrayisevaluatedtocompensatefortemperatureandagingeffects that may influence the optical system. If the compensation needed is excessive, for example because the reference padisbadlysoiledoranLEDisdefectiveandcannotemittherequiredamountoflight,anerrormessageisdisplayed(seeSections7.1and8).

The Urisys 1100® Urine Analyzer assigns each reading a consecutive sequence number (sample number) having a maximumofthreedigits.Thesequencestartnumberautomaticallyrevertsto1eachtimethedateisincremented.Youmayresetthesequencenumberto1viathe“NewSeries”function,forexamplewhenoneseriesofmeasurementshasbeencompleted and another is due to begin.

In AutomaticPatientID mode the instrument will assign automatically unique serial numbers to the tests results which have no Patient IDs. These unique numbers are ascending serial numbers based on the total number of tests performed on the instrument and cannot be altered nor cleared.

After five minutes of inactivity, the analyzer automatically switches to Standby mode. The tray advances slightly so as to close the retaining bar, and the display shows the date and time. The analyzer resumes Ready-to-Measure status when the START button is pressed.

6.2 QualityControlRecommendations

Commercial control material may be used for quality control. Please contact Roche Diagnostics Technical Service at 1-800-428-4674foralistofavailablecontrolsolutions.Positiveandnegativecontrolsmustbetesteddaily,orwhenanewvial of strips is opened (including every lot change), or whenever calibration is performed. Values obtained for these controls should fall within the limits established by the laboratory or the control manufacturer. If control values fall outside the designated ranges, and repetition of the assay excludes errors in technique, contact Roche Technical Service at 1-800-428-4674.

Figure8

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6.3 RoutineUrineTesting

ATTENTION: To ensure that urinalysis is carried out correctly, read the package insert included with the test strips.

The Urisys 1100®UrineAnalyzerisreadytoreadwhenthedisplayshowsasamplenumberand“INSERTSTRIP!”.

Procedure1.Diptheteststripbriefly(onesecond)intheurinesample.Drawthelongedge

of the strip along the rim of the specimen container to remove excess urine. Touch the long edge of the strip to absorbant paper for one second making sure that each pad is blotted. Always wear protective gloves when handling anddisposingofsamplesofhumanorigin(seeFigure9).

2.Placetheteststrip,withthetestpadsfacingupward,onthetraysothatitsleading edge is held by the clip at the end of the test strip tray. The retaining bar must be open(seeFigure10).About2mmofstripmustbeheldundertheclip(seeFigure11).

It is important that the strip is correctly positioned and ready to be read within5-10secondsofdippingstrip.

ATTENTION: To avoid incorrect readings due to a discoloration of the test strip pads, the strip vial must be closed immediately after removal of a test strip, using the original desiccant-filled stopper.

Figure9

Figure10

Figure11

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3.PresstheSTARTbutton(seeFigure12).Thedisplaywillread“Measurementstarts in xx sec.” The display counts down until start. During this time, the strip incubates and the retaining bar remains open.

4.Iftheteststripisnotcorrectlylocatedinthemiddleofthetray,moveitgentlytothesideuntilitisproperlyaligned(seeFigure14).Becarefulnottomovethe tray.

5.Afterthestripincubates,themeasurementbeginswiththeReferencepadand then all test strip pads are read. The tray returns to the Start position and the retaining bar opens.

6.Theresultsareprintedandthenextsamplenumberappearsonthedisplay.

7.Removeanddisposeoftheteststrip.Wipeanyurineresiduefromthetraywithalint-freecloth(seeFigure15).

6.4 PatientReport

The patient report is printed out together with the sequence number, device ID, operator ID, date and time. The patient’s name will also appear on the print out if enteredpriortomeasurement(seeSection6.6).Testresultswhichdivergefromnegative, normal, or trace values are flagged with an asterisk before the parameter concerned. For details regarding various print settings and how to modifythem,seeSection3.3.

Tear off the printout, by pulling it horizontally over the edge.

Figure12

Figure13

Figure14

Figure15

Figure16

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! Thermalprintingpaperissensitivetolightandsubjecttofadewithprolongedexposuretobrightlight.

Patientreportsshouldbekeptinaplaceawayfromdirectlight.Foranticipatedstoragebeyond5yearsitis recommended that reports are photocopied for storage.

6.5 StripMeasurementError

If“STRIPMEASUREMENTERROR!”appears,theteststripand/oranalyzerhaveprobablybeenincorrectlyused.Referto Section8fordetails.

6.6 EnteringPatientID,OperatorIDandAuthenticationPassword

PatientIDWhentheanalyzerisreadytomeasure(“INSERTSTRIP!”displayed),youmayenteraPatientID(upto13charactersinlength)againstthecurrentlyshownsequencenumberbymeansofabarcodereaderorAT/PCkeyboard(seeSection9.2).The Patient ID can be verified in the display window and entered again if necessary. The last Patient ID entered is stored when the START button is pressed (i.e. when reading begins) and is printed and/or sent to the serial interface together with the test result.

A new Patient ID should only be entered from the keyboard after the preceding measurement has been completed and results printed out. This allows the operator to check correct entry directly on the display.

If a Patient ID is entered via the barcode reader while a test strip is being read, the analyzer assigns that ID to the next sample number in the sequence. The Patient ID can only be erased by switching the analyzer off and then on again before starting the next reading.

Operator IDIf the operator ID is activated, the instrument request the input of the operator ID immediately after the self check is performed when the instrument is turned on, or when it leaves the stand-by mode.

YoumayenteranoperatorIDupto12alphanumericcharactersbymeansofabarcodereaderoranAT/PCkeyboard.

AuthenticationIn the authentication mode the user will be required to input his/her apart from the operator ID list, also the corresponding password in order to have access to the instrument and the test results he/she had performed.

Operatorswithsupervisorrightshaveaccesstoallresults,maysendtheinstrumentlogfiletothehostorprintthelast10actions of the log file and may deactivate the authentication mode.

The list of operator IDs with corresponding passwords may be updated from the host PC using the “Download List” function key.

Whendataisenteredfromthekeyboard,eachcharacterappearsimmediatelyinthedisplay.Itcanbeerasedbybackspacing,and corrected as necessary. PressthekeyboardENTERkeytoterminateinput, otherwise the Urisys 1100® Analyzer cannotstartreading.PressthekeyboardEscapekeytodeletetheentireentryorturntheanalyzeroffandthenonagain.

ATTENTION: If the maximum length of identification is exceeded the input cursor will skip to the first character and the identification will be overwritten.

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6.7 DataTransmissiontoaPCorHostComputer

In unidirectional mode, the results are transmitted immediately with the sequence number, Patient ID (if entered), date and time. In bidirectionalmode,transmissioncanonlybeaccomplishedbyusingthe“Send”functionwhen“MEMORY”isdisplayed. If a bidirectional PC/host communication link cannot be established, the Urisys 1100® Urine Analyzer aborts transmissionafterseveralattemptsandreportsan“INTERFACEERROR!”(seeSection8).

In ASTM mode the results, sequence number, Operator ID, Device ID, Patient ID (if entered), date and time of the measurement, and of the last calibration will be sent to the host.

Forfurtherinformationonconnectingtoaserialinterface,refertoSection9.1.

ATTENTION: Ensurethatallrequireddataisbackeduponaregularbasis.

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7. CleaningandMaintenanceThe Urisys 1100® Urine Analyzer is designed for nearly maintenance-free operation. Protect the instrument from extremes oftemperatureandhighatmospherichumidity(seeSection10),andkeepitoutofbrightlight(directsunlight,spotlamps,etc.).

Maintain hygiene by keeping the exterior parts and surfaces of the instrument clean. For cleaning we recommend applying asolutionofeither70%alcoholor10%bleachwithamoistcloth.Itisimportantthatnoliquidenterstheinstrument.

Liquid waste and strip waste are potentially biologically hazardous. Always wear gloves when handling these materials. Dispose of the used test strips according to the regulations for handling potentially infectious material.

Wheninsertingandremovingteststrips,becarefulthatnourineresiduescomeintocontactwiththeretainingbarmechanism.

7.1 RoutineCleaning

Wipetheteststriptraywithasoft,lint-freeclothasneeded(seeFigure15).Thisis important to prevent carry-over of urine between patients and accumulation of urineresiduesthatmighthampersmoothoperationoftheanalyzer.Whenwiping, be careful not to move the tray and that the retaining bar remains open.

7.2 DailyMaintenance

Cleantheteststriptraywithwateranddisinfectwith70%alcoholor10%bleachdaily.

1.Switchofftheanalyzer.

2.Pulltheteststriptrayoutoftheanalyzer.

3.Rinseunderrunningwater.

4.Removeanycrystallinedeposits,especiallythosecontaminatingtheretainingbarmechanismorthecogsontheunderside of the test strip tray, with a soft brush.

5.Wipedowntheteststriptraywitheither70%alcoholor10%bleach.Drywithasoftlint-freecloth.Toavoidcorrosion,do not leave the test strip tray to soak in bleach, alcohol, or other solutions.

! Becarefulnottodamagethegrayreferencepadduringthecleaningprocess.Makesurethereference

pad is completely clean and dry before proceeding to read test strips.

! Besurethepositioningholeonthesideofthetrayisabsolutelydry

(seeFigure17).Thisholeisusedtoensurethattheteststriptrayisautomatically positioned correctly in the instrument.

Figure15

Figure17

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6.Installtheteststriptraybyholdingthetrayoppositetheendwiththegrayreferencepadandinsertingthetrayintotheslot below the function keys.

ATTENTION: Be careful not to touch the gray reference pad. Contamination of the reference pad may impair the quality of the results obtained.

7.Ifyouwishtoproceedwiththenextreadingsdirectlyaftercleaningtheteststriptray,switchtheanalyzeronagain.During the self check, the system will verify that the reference pad is in good condition for reading and that the positioningholeintheteststriptray(seeFigure17)isfree.Ifnot,anerrormessagewillbedisplayed(seeSection8).

8. ErrorMessagesandTroubleshootingErrormessagesareshowninthedisplaybutarenotprintedout.Followingfiveminutesofinactivity,theanalyzerswitchesto Standby mode. The error message is displayed again when the START button is pressed. In the event that the instrument isnotoperatingproperly,contactRocheDiagnosticsTechnicalServiceat1-800-428-4674.

E1REFERENCEPADERROR Cause: The middle portion of the reference pad on the tray is soiled or damaged. MIDDLE! Action: Switch off the instrument. Carefully clean and dry the pad. Check if it is

damaged (e.g. scratched, etc.). Insert the tray again, then wait for the self check to finish. If the error message appears again, contact Roche Diagnostics Technical Serviceat1-800-428-4674.RecalibratewithChemstripCalibrationStrip(whenusing Chemstrip10MD*).

E15REFERENCEPADERROR Cause:The bottom portion of the reference pad on the tray is soiled or damaged. BOTTOM! Action:seeE1

E16REFERENCEPADERRORTOP! Cause:The top portion of the reference pad on the tray is soiled or damaged. Action:seeE1

E2WRONGSTRIP! Cause:The test strip used is different from the one for which the analyzer has beenprogrammed(e.g.“Chem10”teststrip,“Chem5”teststrip,“Chem7”teststrip).

Action: Press the START button. Repeat the measurement with the type of strip for which the analyzer has been programmed.

E3STRIPMEASUREMENTERROR! Cause:Noteststripispresentonthetray,orthestripisincorrectlypositionedonthe tray, the urine on the test strip has dried, the test strip has not been dipped in urine.

Action: Press the START button. Repeat the measurement with a new test strip. Ensurethatalltestpadsaredippedintheurinesample.Insertthestripcorrectlyand ensure that the retaining bar is closed properly after START button is pressed.

E4CALIBRATIONERROR! Cause:Calibration values differ from those obtained in the last valid calibration. Action: Press the START button. Repeat the calibration with a new calibration

striptakenfromtheChemstripCalibrationStripcontainer.Ensurethatthestripisproperlypositionedundertheclipattheendoftheteststriptray(seeSection5).

E5CALIBRATIONINVALID! Cause:Calibration values are out of tolerance. Action: Check the reference pad for soiling or damage. Clean if necessary (see

Section7.1).RepeatthecalibrationwithanewChemstripCalibrationStrip(see Section5).Iftheerrormessageappearsagain,contactRocheDiagnosticsTechnicalServiceat1-800-428-4674.

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E6CHIPERROR! Cause:The program chip on the right of the analyzer underneath the printer cover is missing, is not making contact, is defective or contains an old soft ware version.

Action: Switch off the Urisys 1100® Urine Analyzer. Insert the program chip and switchtheinstrumentonagain.If“CHIPERROR”appearsagain,contactRocheDiagnosticsTechnicalServiceat1-800-428-4674.

E7MISSINGTRAY! Cause: Notrayinsertedortraynotinsertedfarenoughtobeengagedbythemotor.

Action: Insertthetraycorrectly(seeSection4).PresstheSTARTbutton.

E8TRAYPOSITIONERROR! Cause:The positioning hole in the tray is soiled or still wet after cleaning; the retaining bar is open while the tray is advancing; or the retaining bar mechanism isblockedbyurinarydeposit(SeeSection7.1).

Action: Clean, blow through or dry the positioning hole (using a lint-free cloth) to ensure that it is completely clear. Remove urinary deposits, including those on the undersideofthetray.InsertthetrayagainandpresstheSTARTbutton.Ensurethat the retaining bar is down and locked into place while the reading is taking place. If the error message appears again, contact Roche Diagnostics Technical Serviceat1-800-428-4674.

E9WRONGTRAY! Cause:The test strip tray used is not the correct one for the programmed test strip type setting, or the gray reference pad is missing from the tray.

Action: Press the START button. The strip type menu is displayed. The strip type mustmatchthetraytype(seeSection4.2).Usethecorrecttray.Iftheerrormessage appears again, contact Roche Diagnostics Technical Service at 1-800-428-4674.

E10LIGHTBARRIERERROR! Cause:The light barrier used to control the position of the test strip tray is defective or the tray transport is blocked.

Action: Pull out the tray and return it to the start position. Press the START button. If the error message appears again, contact Roche Diagnostics Technical Serviceat1-800-428-4674.

E11TRAYSTEPERROR! Cause:The stepping of the motor is out of tolerance or the advance of the tray is blocked. This may be due to - soiling on or between the cogs on test strip tray

- worn or broken cogs on test strip tray - defective motor. Action: Carefully clean the tray. Remove any urinary deposits, including those on

the underside of the tray and the cogs. Press the START button. If the error message appears again, contact Roche Diagnostics Technical Service at 1-800-428-4674.

E12OPTICSERROR! Cause:Thereferencepadismissingfromthetray,oranLEDorthephototransistor is defective.

Action: Attach the reference pad. Press the START button. If the error message appears again, contact Roche Diagnostics Technical Service at1-800-428-4674.

CLOSEPRINTERCOVER Cause:The printer cover is open. Action: Close printer cover.

NOPAPERINPRINTER Cause:Nopaperhasbeeninsertedorrollisfinished. Action: Insert new roll of paper and close printer cover.

After elimination of printer errors the results can be printed from the instrument‘s memory using the “Print” function.

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E14INTERFACEERROR! Cause:Fault in data transfer to PC or host in bidirectional orASTMmode. Action: Check the data cable. Verify that the PC or host is ready to receive data.

Use the “Send” function to transfer data or press “Home” to resume Ready-to-Measure status.

E17INVALIDPASSWORD! Cause:The entered password doesn’t match. Action: Entercorrectpassword.

E18INVALIDOP.ID! Cause: The entered Operator ID is not valid. Action: EnteravalidOperatorID.

E19LISTDOWNLOADFAILED Cause:The new Operator ID list download failed. Action: Noaction.After2secondsnextstatestartswitholdlistiftherewas.

E20NOVALIDLIST! Cause:There is not a valid list at all in device. Action: Try to download an Operator ID list from the host or continue without

authenticated operator.

CHECKMEASUREMENT Analyzerprintsoutsoftwareandchipversionnumberand3-digitnumberswithout naming the parameters.

Cause: Service function is activated. Action: Press the “Back” function key to return to the main menu. VALUESOBTAINEDARE Cause: Test strip incorrectly positioned or uncharacteristic test pad colors.IMPLAUSIBLEWHEN Thewrongteststrip,mayhavebeenused.ElectromagneticinterferencefromCOMPAREDWITHTHOSEFROM otherdevices(seeSection4).VISUALEVALUATION Action: Repeat the measurement with a new test strip. Follow the directions

carefully and ensure the test strip is correctly inserted. Repeat calibration if necessary. Remove external sources of interference, if there are any.

NOPRINTOUT Cause:“Printer: Off” has been selected, or the printer/software is defective, or the printer is out of paper.

Action: Insert paper if needed. Choose “Printer: On” to re-activate the printer. Request a patient report via the “Print” function. If this fails, activate the “Linefeed” function. If there is still no response, contact Roche Diagnostics Technical Service at 1-800-428-4674.

THEANALYZERWILLNOTREAD Action:IfanAT/PCkeyboardisconnected,presstheEscapekey,orswitchtheEVENTHOUGHTHESEQUENCE Urisys 1100® Urine Analyzer off and back on again. NUMBERISDISPLAYED

9. ConnectingtoOtherDevices9.1 SerialInterface

At the rear, the Urisys 1100® Urine Analyzer has a serial interface through which it can be connected to a PC or central host computer.ThisisnotanRS232typeinterface.

RocheDiagnosticshasasuitablestandarddatacableavailableforsale(seeSection11).

The interface can be used for unidirectional, bidirectional orASTM communication, selected via the menu.

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Whentheinterfaceissetforunidirectionalcommunication,thedataissentasanASCIIfileandcanbereceivedviaaterminal program.

The entered Patient ID appears in the Urisys 1100® Urine Analyzer display window and is also printed and/or sent to the PC/hostalongwiththetestresults(seeSection6.6).IfbidirectionalcommunicationwithaPCorhostcomputerhasbeenselected,themaximumlengthofthePatientIDused(either10or13characters)mustbepreprogrammedviathedisplaymessage“INTERFACE:BIDIR.”andthefunction“10/13”toensurethatthecorrectdataissent.

For further information and specifications for operation in bidirectional or ASTM mode, e.g. for connection to a host computer,contactRocheDiagnosticsTechnicalServiceat1-800-428-4674.

Interface specification:9600baud,8bits,1stopbit,noparity(forunidirectionalandbidirectionalmodes).SelectablebaudratesinASTMmode:1200,2400,4800,9600,19200and38400.

Data cable:D-sub,9–pin,maleoninstrumentside,femaleonPCside.

Connections:Urisys 1100® Urine Analyzer Host (PC pinout 9-pin) 2_______________ RxD _______________2 3_______________ TxD _______________3 4_______________ DTR _______________4 5_______________ GND _______________5 6 6 7 7 8 8 9 9

! The use of a data cable not meeting the Roche Diagnostics specification can cause data to be lost or

corrupted.

9.2 BarcodeReader,AT/PCKeyboard

Sample or Patient IDs, Operator IDs and corresponding passwords can be entered against each sample sequence number displayed on the LCD, either via a barcode reader (see recommended reader) or via an AT/PC keyboard. A suitable keyboardisavailablefromRocheDiagnostics(seeSection11).Powerissuppliedbythebarcodereaderinterface.

Interface specification: 5-pinDINsocket,female

Pinouts: 1 clock 2 data 3 n/c 4 GND 5 +5V

BarcodeReaderBarcodereaderssuitableforusewithUrisys1100®UrineAnalyzerwithSWversion6.0andabovemustmeetthefollowingspecifications:-RadiofrequencyinterferenceclassBaccordingtoEN61326-1-ElectromagneticinterferenceimmunityrequirementsforindustriallocationsaccordingtoEN61326-1-Part15ofFCCrulesforaclassBcomputingdevice.

ThereisarecommendedbarcodereadertoreadcommonlyusedbarcodessuchasCodabar,Code39,Code128andInterleaved2of5.

IfabarcodereaderandanexternalkeyboardhavetobeconnectedadatacableCAB322IBMAT/XTDINisneeded.

ForquestionsregardingtheoperationoftheUrisys1100® Urine Analyzer with barcode readers, please contact your local Roche Diagnostics representative.

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10.TechnicalInformationandNotices10.1 InstrumentSpecifications

Dimensions: Width: approx.150mm Depth: approx.290mm Height: approx.95mm

Weight: < 0.8kg

Powersupply: Externalmainsadapter,ModelSA125A-0735U-S(Sino-AmericanSwitchingAdapter) Input:100-240VAC,50-60Hz,800mA Output:7.5VDC,3000mA Polarity: – +

Consumption: Operating: max.15W Standby: 1.3W

System description: Type: reflectance photometer Lightsource: 6LEDs(lightemittingdiodes) Wavelengths: 565nm(green)3x 610nm(orange)3x Readerhead: 1headwith6LEDs Measuringcycle: approx.70sec Max.throughput: approx.50strips/hour Incubationtime: 55-65seconds Printer: thermal printer Display: liquidcrystaldisplay,2linesof24characters Memory: 100samples Date, time: integrated clock

Operating conditions: Operating In storage Temperature: 15to32°C -20to70°C 59to90°F -4to158°F

Relativehumidity: 20%to80% 20%to85%

Interfaces: PC/HOST: serial,D-Subsocket,9-pin,female,unidirectional, bidirectional orASTM protocol (selectable) AT/PCkeyboard: 5-pinDINsocket,female Barcode reader

Certificationmarks: UL, cUL

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10.2 SafetyNotices

This analyzer was designed and manufactured to comply with following international regulations, “Safety requirements for electrical equipment for measurement, control and laboratory use” and left the factory in a safe condition. In order to keep the instrument in a perfect and safe condition, it is up to the user to observe all instructions and warnings included in this manual.

ThisproductfulfilstherequirementsofDirective98/79/EConinvitrodiagnostic medical devices.

C US Issued by Underwriters Laboratories Inc. (UL) for the USA and Canada.

The instrument must only be operated with the prescribed power supply unit (Class II protection).

TheinstrumentisclassifiedasCategoryIIforovervoltageandDegree2forpollutionaccordingtoIEC664.

Opening covers or removing parts of the instrument, except where this can be achieved manually without the use of any tools,mayexposevoltage-carryingcomponents.Connectorscanbelive.Nevertrytomaintainorrepairanopeninstrumentwhich is carrying voltage.

If you suspect that the instrument can no longer be operated safely, turn it off and take steps to ensure that no one will subsequentlyattempttouseit.MakesurethatonlytrainedmembersofstaffoperatetheUrisys1100® Urine Analyzer.

AnypersonalcomputertowhichtheanalyzerisconnectedmustmeettheEN60950,UL60950andCSAC22.2No.60950 requirements for data processing equipment.

If the instrument is to be taken out of operation entirely and disposed of, it must be disposed of in conformity with the relevant legal regulations and in co-ordination with your local authority, if appropriate.Please note that the instrument may potentially be infectious. It should therefore be decontaminated before disposal, e.g. by cleaningthehousingandtheteststriptraywith70%alcohol.

ATTENTION: The data and information contained in this manual are accurate at the time of printing. Any substantial changes will be incorporated in the next edition. In case of conflict between this manual and information given in package inserts, the package inserts shall take precedence.

10.3Warranty

RocheDiagnosticswarrantstheUrisys1100® Urine Analyzer against defects in material and workmanship (except for consumable items) for a period of one year. Roche Diagnostics willreplacetheinstrument provided written notice of defectwithin30daysofoccurence,allpartswhichprovetobedefectiveandsubjecttosuchwarranty.

This warranty does not apply to an instrument not used according to instructions or damaged by accident, alteration, misuse, tampering, and/or abuse.

THEFOREGOINGWARRANTYSHALLBEINLIEUOFALLOTHERWARRANTIES,WHETHEREXPRESSED,IMPLIEDORSTATUTORY,INCLUDING,BUTNOTLIMITEDTO,ANYIMPLIEDWARRANTYOFMERCHANTABILITYORFITNESSFORAPARTICULARPURPOSE.

ROCHEDIAGNOSTICSSHALLHAVENOFURTHEROBLIGATIONORLIABILITYWITHRESPECTTOTHEINSTRUMENTORPARTSTHEREOFORITSSALE,OPERATION,ORUSE,ANDROCHEDIAGNOSTICSNEITHERASSUMESNORAUTHORIZESTHEASSUMPTIONOFANYOBLIGATIONORLIABILITYINCONNECTIONWITHSAIDINSTRUMENTSORPARTSTHEREOF.

CUSTOMERS’SOLEANDEXCLUSIVEREMEDYINCONTRACT,TORT,ORUNDERANYOTHERTHEORYAGAINSTROCHEDIAGNOSTICS,RESPECTINGTHEINSTRUMENT,PARTSTHEREOFANDTHEUSEOFSAMESHALLBETHEREPLACEMENTORREPAIROFTHEINSTRUMENTANDITSPARTSASDESCRIBEDABOVE.INNOCASESHALLROCHEDIAGNOSTICSBELIABLEFORINCIDENTALORCONSEQUENTIALDAMAGES.

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11.OrderingInformationandReplacementPartsThe analyzer, consumables, replacement parts and accessories are:

Catalog No.

03617556001 Urisys 1100® Urine Analyzer Contents: Power Supply with AC Adaptor and US Power Cord, Program Chip, Test Strip Trays (Type C andN),PrinterPaper,Operator’sManualwithPoliciesandProceduresCD,QuickReferenceGuide,andUser Training CD.

03260763160 Chemstrip®10MDUrineTestStrips(100teststrips)11008552160 Chemstrip®7UrineTestStrips(100teststrips)11893467160 Chemstrip®5 OBUrineTestStrips(100teststrips)11379194160 ChemstripCalibrationStrip(50calibrationstrips)

ReplacementParts:

04340612001 PowerCord(US)04340647001 ACAdaptor(ModelSA125-0735U,100V-240V,50-60Hz)03666735001 TeststriptrayTypeCforChemstrip®10MD03666913001 TeststriptrayTypeNforChemstrip®5OB/Chemstrip®706431321001 Thermalpaper(20rolls)11907131001 Sparereferencepads(5pieces)

Optional accessory items:

11248693001 KeyboardforpatientIDentry(English)11906186001 InterfaceCable06919235001 BarcodeReader

PleasecontactRocheDiagnosticsTechnicalServiceat1-800-428-4674forquestionsregardingtheseitems.Toorder,pleasecontactyourlocaldistributororcallRocheDiagnosticsCustomerServiceat1-800-428-5076tolocateadistributornear you.

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12.ContactInformation

Address

Roche Diagnostics Corporation 9115HagueRoad POBox50457 Indianapolis,IN46250-0457 USA

PhoneNumbers

Mainswitchboard: 317-521-2000 CustomerService: 800-428-5076 TechnicalService: 800-428-4674

Website

www.poc.roche.com

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03617599001(04)2012-12US

cCOBAS,LIFENEEDSANSWERS,URISYS1100andCHEMSTRIParetrademarksofRoche.

Distribution in the USA by:Roche Diagnostics9115HagueRoadP.O.Box50457Indianapolis,IN46250-0457

Roche Diagnostics GmbHSandhoferStrasse11668305MannheimGermany

www.poc.roche.com

REF03617599001

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Documents

Urisys 1100 Operator’s Manual - Amazon Web Services 1100® Operator’s Manual man_03617599001_04_US.indd 1 10.01.2013 14:21:14 Last update: 2012-12 The packaging material, the identification