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Bayer DCA2000 - Frank`s Hospital Workshop

1. 6 7 TROUBLESHOOTING 6 10 6 1 ON SNILOOHSTIS OQO LL Y SAGOD WOUNA SHO VSSAW ONINSIVM ANV YOUN ON ERROR AND WARNING MESSAGES ERROR CODES amp TROUBLESHOOTING ERROR AND WARNING MESSAGES ERROR CODES AND TROUBLESHOOTING ERROR AND WARNING MESSAGES ERROR OR WARNING CANCELLED DISCARD TEST 02 24 03 10 18AM CAUSE The cartridge compartment door was opened while testing was in progress The door was then closed and PLEASE WAIT was displayed prior to CANCELLED DISCARD TEST OR was pressed in response to SEE OPERATING MANUAL any system error SOLUTION Open the cartridge compartment door Remove and discard the reagent cartridge Repeat the test If the error message SEE OPERATING MANUAL any system error is displayed again refer to Section 9 for instructions on How to Report the Problem DOOR OPEN ERROR CLOSE DOOR The cartridge compartment door was opened while testing was in progress Close door Wait for next display PLEASE WAIT OUT OF DATE CONTROL LOTC 1154 HbA1c displayed for 15 seconds Control lot number and test name above are examples only The bar code for an out of date control past expiration date has been read Discard out of date control s OUT OF DATE REAGENT LOT 1154 HbA1c displayed for 15 seconds Reagent lot number and test name above are examp
2. 6 3 WRONG CARD seen nennen nennen E FEE e TRE rE o es 6 3 ERROR CODES X 6 4 De ida RE eee noni he RD 6 4 BIS M Are fo e MU E 6 4 ll 6 5 E558 hodie Atene e E RE e sex SD ede 6 5 E36 hae ias 6 5 Hemoglobin A Microalbumin Creatinine ERROR 101 6 6 ERROR 301 6 8 ERROR 102 6 6 ERROR 302 6 8 ERROR 103 6 6 ERROR 303 6 8 ERROR 104 6 6 ERROR 304 6 8 ERROR 105 6 6 ERROR 305 6 8 ERROR 106 6 6 ERROR 306 6 8 ERROR 107 6 6 ERROR 307 6 8 ERROR 1068 6 7 ERROR 308 6 8 ERROR 109 6 7 ERROR 309 6 9 ERROR 110 6 7 ERROR 310 6 9 ERROR 111 6 7 ERROR 311 6 9 ERROR 112 6 7 ERROR 313 6 9 ERROR 113 6 7 ERROR 315 6 9 ERROR 114 6 7 ERROR 316 6 9 ERROR 115 6 7 ERROR 116
3. Allow at least 10 minutes after cartridge is removed from refrigerator before starting test Ensure that cartridge is inserted completely into instrument Pull buffer tab after inserting cartridge into holder If problem persists contact Bayer HealthCare Customer Service Department See Section 9 Service Information 105 High Variation in Readings for Buffer Condensation on cartridge cartridge not allowed to warm up Rare Particulate contamination Allow at least 10 minutes after cartridge is removed from refrigerator before starting test If problem persists contact Bayer HealthCare Customer Service Department See Section 9 Service Information 104 106 Reading for Hemoglobin Value Low 105 107 Reading for Hemoglobin Value High 6 6 No or low blood in reaction capillary underfill or air bubble blood dried in capillary no capillary holder inserted improper reconstitution of controls or use of non DCA 2000 controls Hemoglobin 7 g dL anemic patient abnormally low hemoglobin Buffer tab not pulled or buffer not released from tray Excess blood on capillary holder Blood not lysing cartridge not allowed to warm up irregularity in patient red blood cells rare Hemoglobin gt 24 g dL patient has abnormally high hemoglobin very high triglycerides Ensure that capillary is completely filled with no air bubbles Wait
4. E RECALL CONTROL RESULTS VIEW CALIBRATION STATUS E SET DATE TIME INSTRUMENT SETUP E H SET CREATININE UNITS INSTRUMENT TEST RUN CONTROL optional Revised 6 03 To access the MENU and display the first item Press To display each additional item Repeatedly press To select the item displayed Press To exit the MENU e Press Information and instructions for each MENU item are provided in this section 3 1 MENU RECALL PREVIOUS TESTS Up to 16 test results can be recalled and printed if a printer is in use Recalled Test Result Format Test Assay Result Type Reagent Lot No 6 0 HbAlc LOT 0325 02 24 03 011 11 24PM Date of Assay Sequence No Time Assay Began optional DISPLAY WHAT YOU DO WAIT WARMING UP 02 24 03 2 09PM T PED OR READY SCAN BAR CODE 02 24 03 2 09PM OR TEST IN PROGRESS 001 6 MIN 10 15AM Test in progress is not aborted when MENU is pressed 3 2 Revised 6 03 DISPLAY WHAT YOU DO RECALL PREVIOUS TESTS 2 Press The test result for the sample most recently assayed is displayed first 6 0 HbA1c LOT 0325 02 24 03 011 11 24PM 3 Press to recall up to 16 test results example ple NOTES OR e To print the displayed test result press if a printer is in use If is pressed for more than 3 seconds all stored A 55 0mg L LOT 0325 test results are printed To return display to RE
5. a Open cartridge compartment door b Locate the button on the right side of the cartridge compartment Push and hold it down with your right hand c With your left hand gently push the tab on the cartridge to the right this action releases unlocks cartridge d Pull the reagent cartridge out of the compartment e Discard cartridge in proper container according to your standard laboratory procedures If the door is opened within 15 minutes after assay completion the test result is displayed for only 30 seconds If the door is not opened the test result will remain displayed for 15 minutes At 15 minutes an audible tone error buzz sounds and the display changes to READY REMOVE TEST HINT If the displayed test result was not recorded use the MENU to recall up to 16 test results refer to SECTION 3 4 10 Revised 6 03 RESULTS The displayed test result requires no further calculation Hemoglobin Aj concentrations in the following range are reported 2 596 to 14 096 The test is linear throughout this range Result preceded by a less than sign A less than sign in the display indicates a concentration below the lower limit of the test under range Report the result as being less than 2 5 Hemoglobin A c This method does not provide for re assay using a larger sample aliquot Results less than 2 5 Hemoglobin Aj are rare and may indicate that the sample contains substantial amounts o
6. the display returns to the original display i e either display shown in Step 1 the test in progress continues without interruption Revised 6 03 4 15 OPERATING INSTRUCTIONS HEMOGLOBIN Ate DISPLAY WHAT YOU DO READY SCAN BAR CODE 02 24 03 2 09PM 3 The test 1s cancelled e Scan bar code displayed if the test is cancelled after the bar code is scanned but before the cartridge compartment door is opened a beep is heard OR OR Open cartridge compartment door and CANCELLED DISCARD TEST remove cartridge 02 24 03 10 18AM displayed if the test is cancelled during sample analysis cartridge is in instrument an error buzz is heard 4 16 Revised 6 03 OPERATING INSTRUCTIONS MICROALBUMIN CREATININE NOTE The instructions in this section are for use after INSTRUMENT SETUP has been performed a one time requirement upon receipt of a new or factory serviced instrument STEP 1 Turning the Power ON DISPLAY After about 8 seconds SOFTWARE VERSION E3 11 01 04 displayed for 8 seconds COPYRIGHT 1991 2003 BY BAYER CORPORATION displayed for 3 seconds INITIALIZING KEEP DOOR CLOSED WAIT WARMING UP 02 24 03 2 09PM READY SCAN BAR CODE 02 24 03 2 09PM a beep is heard Revised 6 03 WHAT YOU DO 1 Turn the power switch to ON IMPORTANT The program card must be inserted or removed only when the power switch is set to OFF If the card is inserted whe
7. Tool Required Screwdriver Fuse Required 250 V T 1 25A Instrument Model No 5031C One replacement fuse is stored in the fuse holder The fuse holder is located on the back panel of the instrument between ON OFF switch and power cord connector replacement fuse l WARNING Set the power switch to 1 f OFF Unplug power cord from wall blown fuse outlet Unplug power cord from instrument ireti VAROITUS Kytke virta pois off asento Irrota virtajohto 5 Remove and dispose of blown fuse sein pistokkesta Irrota virtajohto laitteesta 6 Push the replacement fuse out of the black box 2 Locate the groove on the side of the fuse holder using the tip of a screwdriver or similar device that faces power cord connector B 7 Insert replacement fuse onto fuse block WARNING For continued protection against fire hazard replace only with the indicated type and rating of fuse N VAROITUS Paloturvallisuussyist k yt vain suositeltuja sulakkeita 8 Re insert fuse holder into instrument snap gently into place 3 Insert the tip of a screwdriver into the groove Then exert pressure to unsnap fuse holder from instrument Revised 6 03 8 1 SERVICE INFORMATION When you have a problem with the System Refer to Troubleshooting Section 6 of this Manual If Section 6 cannot assist you in solving the problem answer all of the following questions before contacting us for help The r
8. calibration 5 2 capillary 4 5 5 5 card 3 3 caution 1 1 4 1 cleaning 2 1 compartment 2 2 computer 1 1 3 16 computer port 2 9 concentration 2 16 copyright 2 5 cursor 2 10 definition 3 13 displayed 2 3 electrical 1 1 2 4 electronic 2 1 error 6 1 F finger 4 6 foil 4 3 format 3 2 Revised 6 03 G glutaraldehyde 7 2 grounded 2 4 humidity 1 1 2 4 important 2 3 insert 5 4 installation 1 1 IVD 1 1 L laboratories 1 1 mechanical 2 5 memory 2 8 menu 2 8 mg dL 2 16 mmol L 2 16 O operational 1 1 optical 2 1 P power 2 1 printer 1 1 3 16 procedures 4 3 progress 3 8 prompts 2 2 ratio 3 3 reagent 1 1 recall 3 7 reconstitution 1 2 Index 1 1 INDEX S safety 1 1 sequence 2 8 3 4 sodium hypochlorite 7 2 software version 2 5 specifications 1 1 spring 2 2 standards 1 1 sunlight 2 4 T tab 2 2 temperature 1 1 2 4 U unpacking 2 8 urine 1 1 5 6 use by 1 2 V venipuncture 4 6 W warning 1 1 4 5 warranty 1 1 Index 1 2 Revised 6 03
9. the cartridge is damaged the flexible pull tab is loose or missing the small sack desiccant is missing or open loose desiccant particles are found inside the foil package refer to Service Information Section 9 4 3 OPERATING INSTRUCTIONS HEMOGLOBIN Ate CAPILLARY HOLDER Unused capillary holders may be saved and used with any lot of Hemoglobin Aj reagent cartridges 1 Open plastic wrap by tearing wrap at serrated edge 2 Inspect the capillary holder for the presence of absorbent pad glass capillary latching mechanism If the capillary holder is missing any of the above parts discard the capillary holder refer to Service Information Section 9 4 4 Revised 6 03 FILLING THE CAPILLARY Instructions for filling capillary with WITH WHOLE BLOOD control sample are found in the DCA 2000 Hemoglobin Aj Control package insert IMPORTANT PLEASE READ CAREFULLY Once the capillary is filled with sample analysis must begin within 5 minutes There is no need to rush Five minutes allows enough time for proper completion of procedures Within 5 minutes after filling glass capillary step 1 next page complete steps 2 5 page 4 7 and one of the following whichever applies EITHER For a Patient Sample or any control other than DCA 2000 Control Steps 1 through 9 under WHAT YOU DO on pages 4 8 4 9 OR e For DCA 2000 Control Steps 1 through 14 under WHAT YOU DO on pages 4
10. Push and hold it down with your right hand c With your left hand gently push the flexible tab on the cartridge to the right this action releases unlocks cartridge d Pull cartridge out of compartment e Discard cartridge in proper container according to your standard laboratory procedures If the door is opened within 15 minutes after assay completion the test result is displayed for only 30 seconds If the door is not opened the test result will remain displayed for 15 minutes At 15 minutes an audible tone error buzz sounds and the display changes to READY REMOVE TEST Revised 6 03 CANCELLING A TEST You may cancel a test anytime Important If a test in progress is cancelled the test must be discarded DISPLAY WHAT YOU DO LOAD CARTRIDGE INSERT PLUNGER PRESS lt 1 Press O OR PULL TAB CLOSE DOOR OR TEST IN PROGRESS 001 6 MIN 10 15AM colon does not blink CANCEL TEST T Suse Log T0 CUDETUD 2 Press 9 within 15 seconds NOTE After pressing PLEASE WAIT is an error buzz sounds displayed until the cartridge returns to original loading position Q If is not pressed within 15 seconds e the display returns to original display i e either display shown in Step 1 the test in progress continues without interruption continued on next page Revised 6 03 5 15 OPERATING INSTRUCTIONS MICROALBUMIN CREATININE DIS
11. Section 3 MENU for instructions on how to access INSTRUMENT SETUP HINT Don t press until all settings on Line 1 reflect your Cursor The cursor is the underline in the display The cursor shows you which setting is ready for change 11400 TIME FORMAT AM PM Reminder If the underlined number is acceptable press The cursor then moves horizontally right to the next number on line 1 while line 2 defines the corresponding option and setting choice Only when all numbers shown in Line 1 are acceptable press The cursor does not move in reverse left To change a number to the left of the cursor repeatedly press El until the cursor returns to the desired location choices DISPLAY WHAT YOU DO A 1 Press places a cursor under factory setting for first option TIME FORMAT 11400 TIME FORMAT AM PM 2 10 2 Press 4 and 3 to cycle through choices for TIME FORMAT When the desired choice is displayed press moves cursor under setting for next option Revised 6 03 DISPLAY 11400 DATE FORMAT MM DD YY 11400 LABELS USED TIME DAILY S DCA 2000 11400 COMPUTER PORT OFF Revised 6 03 WHAT YOU DO Press 4 and 3 to cycle through choices for DATE FORMAT When the desired choice is displayed press moves cursor under setting for next option Press 4 and 3 to cycle through choices for LABELS When the desired choice is displayed
12. the instrument The instrument contains sensitive electronic and optical parts Check each item for shipping damage Report shipping damage to the representative of the carrier or to your Bayer HealthCare Sales Representative CARTON CONTENTS Some instruments will require a separately packed Installation Kit containing language specific instructional materials Program Card Operating Manual and Quick Reference Guide Cleaning Kit Air Filter Replacement Kit and the appropriate Power Cord DCA 2000 4 Analyzer Cleaning Kit EH Optical Test Cartridge in instrument cartridge compartment Program Card Power Line Cord Be Other not shown Operating Manual Replacement Fuse stored in fuse holder located inside the instrument Air Filter Replacement Kit e HbA Quick Reference Guide Revised 6 03 Missing Items Contact the nearest Bayer HealthCare office or authorized distributor 2 1 N dN LAS ANV G amp aLNIVAOOV DNILLAD 9NDIOVdNDn NO UNPACKING GETTING ACQUAINTED AND SET UP UNPACKING GETTING ACQUAINTED AND SET UP Unlock and then remove the optical test cartridge according to the following instructions 1 Open the cartridge compartment door YXA B i 2 Locate the button on the right side of the cartridge compartment Push and hold it down with your right hand 3 With your left hand gently push the plastic tab on the cartridge to the right this
13. 1 sec and smoothly slide the reagent cartridge down past the dot A beep sounds to signal a successful scan f no beep sounds repeat procedure If a beep repeatedly fails to sound refer to Troubleshooting Section 6 Open the cartridge compartment door Hold the reagent cartridge so that the bar code faces right Insert the reagent cartridge into the cartridge compartment until a subtle snap is heard felt HINT The reagent cartridge is designed to fit only one way into the instrument Do not force cartridge into instrument Using a smooth slow continuous motion pull flexible pull tab completely out of reagent cartridge Close door Dispose of flexible pull tab NOTE If you accidentally close the door before you pull the tab you have 5 seconds to re open the door the display returns to LOAD CARTRIDGE You may now pull the tab or correct existing problem s 4 13 p ITY NICO TOOWAH SNOLLONULSNI ONILVUAdO I OPERATING INSTRUCTIONS HEMOGLOBIN Aic OPERATING INSTRUCTIONS HEMOGLOBIN Ate DISPLAY PROCESSING CONTROL C1 HbA1c 6 MIN 11 11AM colon does not blink After test is completed For a result within the acceptable control range printed in the control package insert AHbAT1c 5 1 C1 10 21AM OR For a result outside the acceptable control range printed in the control package insert CONTROL OUT OF RANGE PRESS CESC TO PROCEED 4 14 WHAT YOU DO 15 16 NOTE I
14. 6 If your instrument is connected YES NO to a printer or computer are all cables securely attached 7 List error messages that have appeared 8 Record the exact sequence of events that took place when the failure occurred and any results obtained 9 Be prepared to perform a complete test procedure when you call for assistance Third Contact the nearest Bayer Diagnostics office or authorized distributor 9 2 Revised 6 03 REPLACEMENT PARTS Part Number Description ACCESSORY ITEMS Part Number Description Hemoglobin A SR002810 5035C DCA 2000 Reagent Kit 5068A DCA 2000 Normal amp 40330028 Abnormal Control Kit 40330046 40330050 Microalbumin Creatinine 50214149 6011A DCA 20009 Reagent Kit 50546216 6012A DCA 2000 Low amp High 625 0127 01 Control Kit 95001901 NOTE Part numbers are subject to change 95002911 without notice 95002117 95002836 Program Card for Instrument English N A Power Cord for Instrument Euro Power Cord for Instrument U K Power Cord for Instrument Filter Holder Cartridge Return Spring Fuse T 1 25A Slow Blow 250V Cleaning Kit Optical Test Cartridge Air Filter 8 Replacement Kit Operating Manual NO NOLLVIASIOJNI HOIAIAS TO ORDER NOTE Part numbers are subject to change without notice Contact the nearest Bayer HealthCare office or authorized distributor Distributed by Bayer HealthCare LLC Elkhart IN 46515 USA Bayer Au
15. After 1 minute 1 0001 T 0 00012 SD S1 5 MIN 10 03AM Upon completion of test 1 0001 T 0 00012 SD 1 0 00387 DRIFT 2 18 WHAT YOU DO 6 Open the cartridge compartment door 7 Hold the optical test cartridge so that the bar code faces right Insert the cartridge into the compartment until a subtle snap is heard felt HINT The cartridge is designed to fit only one way into the instrument Close door Record the displayed results in the blanks provided on the last page of this manual appendix Remove cartridge a Open cartridge compartment door b Locate the button on the right side of the cartridge compartment Push and hold it down with your right hand c With your left hand gently push the plastic tab on the cartridge to the right this action releases unlocks cartridge d Pull cartridge out of compartment If the door is opened within 15 minutes after assay completion the test result is displayed for only 30 seconds If the door is not opened the test result will remain displayed for 15 minutes At 15 minutes an audible tone error buzz sounds and the display changes to READY REMOVE TEST Revised 6 03 MENU The MENU consists of up to nine 9 items listed below Note that item number two and item number nine are optional may or may not be active depends upon choices made during Instrument Setup 1 RECALL PREVIOUS TESTS E SET SEQUENCE NUMBER optional
16. HealthCare office or authorized distributor Otherwise continue with Viewing Factory Settings next Revised 6 03 2 5 NO UNPACKING GETTING ACQUAINTED AND SET UP UNPACKING GETTING ACQUAINTED AND SET UP VIEWING FACTORY SETTINGS Upon Receipt of a New or Factory Serviced Instrument Only upon receipt of a new or factory serviced instrument the following display appears just after INITIALIZING KEEP DOOR CLOSED INSTRUMENT SETUP PRESS C lt TO CONTINUE Before the instrument can analyze samples for the first time it is necessary for you to either accept or change factory settings To view factory settings press cce g r a o0 Uo Line 1 shows the factory setting numbers Line 2 shows the factory setting options The options in Line 2 correspond directly to the number above them in Line 1 The following chart defines the factory setting now active for each available option FACTORY SETTING OPTION NUMBER DEFINITION T Time 1 AM PM D Date 1 Month Day Year L Labels 4 Time Assay Began displayed Sequence Number reset with results daily automatically at midnight C Controls 0 Use of DCA 2000 Controls only P Port 0 Computer Port is turned Off O Before deciding to accept factory settings review the chart under OPTIONS on the following pages 2 6 Revised 6 03 This page left blank on purpose Intended for future use Revised 6 03 2 7 N UNPACKING G
17. If computer port is On WHAT YOU DO 5 Press places a cursor under the setting for the first option TIME FORMAT 6 Press 4 and 9 to cycle through choices for TIME FORMAT When the desired choice is displayed press moves cursor under setting for next option 7 Repeat step 6 to change settings for each option as desired Revised 6 03 SET CREATININE UNITS Microalbumin Creatinine Assay ONLY The concentration units reported for creatinine are selectable between mg dL and mmol L The factory setting is mg dL DISPLAY WHAT YOU DO READY SCAN BAR CODE 02 24 03 2 09PM 1 Press ET REATININE UNITS d d i 2 Repeatedly press until maus SET CREATININE UNITS is displayed SEMEN DES 3 Press This places a cursor below the m mg dL in mg dL and the question mark disappears SECRE A TENTE E US 4 Press 4 or Y to display mmol L or mmol L mg dL SEPOORERE DNE UD 5 Press to accept desired units mmol L 6 Press to exit the MENU Revised 6 03 3 15 MENU Ed INSTRUMENT TEST This menu item is to be used only under the guidance of our Bayer HealthCare Customer Service Department Representative Using this menu item allows you and our Customer Service Representative to determine existing problems with the keyboard display bar code reader printer port memory and computer port functions 3 16 Revised 6 03 Ed
18. clark chee SY Aye ee LU LUE E EE 7 3 Cartridge Compartment A A AAA ee nv LM 7 4 Running Optical est Carttidge o dec eo nghi yeu LP ares pea UR lepra tcd t e 7 6 SECTION 8 Minor Repair How to Replace the Fuse sede eee e e ep vea Rv ER A on S La terc tn atu nu ON 8 1 SECTION 9 Service Information How to Report the Problemi oer cues Pra urs geom e uto ex rq ea by unt euivadtuppedes Tara ed cen 9 1 Accessory Items and Replacement Parts e a e Le tulit de e abd 9 3 APRENDE ia eS cacy C iade ptm e pisa I fat i Pa o raa AAA App 1 1 1v Revised 6 03 INTRODUCTION The DCA 2000 System consists of e DCA 2000 Analyzer e DCA 2000 Reagent Cartridges Capillary Holders and Calibration Card DCA 2000 Controls Optical Test Cartridge INTENDED USE The DCA 2000 Analyzer quantitatively measures e the percent concentration of Hemoglobin Aj in blood e the concentrations of Microalbumin and Creatinine in urine FEATURES easily calibrated using the bar code card provided with each reagent kit stores calibrations for up to two lots of reagent e stores up to 16 test results e stores up to 16 control results can be connected to a computer and or printer SPECIFICATIONS Power Required Instrument Model No 5031C 100 240 VAC 0 4 amps 50 60 Hz Dimensions Weight Depth 27 2 cm 10 7 in without power line cord Width 24 1 cm 9 5 in Height 23 9 cm 9 4 in Weight 5 kg 11 lbs Ambient Operating T
19. no more than 5 minutes after filling capillary before starting test Repeat test with capillary holder in place Review procedure for reconstitution of DCA 2000 controls Perform test by another method Pull buffer tab before closing door Take care in sampling the blood to avoid excess blood on capillary holder Ensure that capillary is wiped before inserting into cartridge Allow at least 10 minutes after cartridge is removed from refrigerator before starting test Freeze thaw specimen before use or perform test by another method Perform test by another method See reagent kit insert under Limitations Revised 6 03 ERROR CODE 108 High Variation in Readings for Hemoglobin CAUSE Rare Particulate contamination SOLUTION If problem persists contact Bayer HealthCare Customer Service Department See Section 9 Service Information 109 110 111 112 Readings for Glycated Hemoglobin Out of Limits Cartridge exposed to excessive temperature and or humidity Ensure proper storage of reagent kits Open foil package just prior to use of cartridge 113 114 116 Irregular Reaction Kinetics for Glycated Hemoglobin 115 Final Hemoglobin Reading Greater Than Reading at Earlier Checkpoint Revised 6 03 Cartridge exposed to excessive temperature and or humidity Particulate contamination Blood left too long in capillary Ensure proper storage of reagent kits Op
20. sound refer to Section 8 for instructions on How to Report the Problem Capillary will not fill completely with sample Discard capillary holder Flexible tab tears off before it is pulled completely out of reagent cartridge 6 10 Discard the reagent cartridge e Refer to Section 9 for instructions on How to Report the Problem Revised 6 03 INSTRUMENT CARE AND ROUTINE MAINTENANCE INSTRUMENT CARE The DCA 2000 Analyzer contains sensitive electronics and optics IMPORTANT Do not use sprays Sprays will permanently damage the optical system Handle the instrument with extreme care Severe mechanical shocks can damage and or dislodge internal parts and connections Do not block the ventilation panels found on the back and right sides of the instrument Allow at least two inches of air space between the wall or other surface and the back and right sides of the instrument Do not operate the instrument beyond the recommended maximum ambient operating temperature or relative humidity ranges listed below Maximum Ambient Operating Temperature ud us 15 32 C Hemoglobin A1c d T 18 30 C Microalbumin Creatinine Relative Humidity 10 90 RH Do not place the instrument where it would be exposed to direct sunlight extreme temperature variations particulate matter excessive humidity or air currents Do not smoke in the room where you have placed the instrument Smoke may cau
21. the compartment Release let go of spring NOTE When step b above has been properly completed the return spring should be free to slide up and down within the cartridge compartment If not repeat step b above IMPORTANT Never force the spring into the cartridge compartment Forcing the spring into the compartment will damage the spring c Gently and carefully push down on edge of cartridge return spring with hole and insert edge into slot Repeat step c to attach opposite side of cartridge return spring to cartridge compartment IMPORTANT When the cartridge return spring is placed back into the instrument the leaf spring must be orientated toward the back of the instrument and cartridge return spring must be securely attached via the grooves tracks and slots IMPORTANT Failure to properly replace return spring can result in erroneous test results Run optical test cartridge according to instructions that follow Allows you to verify that the optical system was not damaged or contaminated by dust etc during this maintenance procedure 7 5 HAVO LNAWNALSNI AONVNALNIVIA ANILAOA ANV INSTRUMENT CARE AND ROUTINE MAINTENANCE INSTRUMENT CARE AND ROUTINE MAINTENANCE RUNNING THE OPTICAL TEST CARTRIDGE Standard 1 The provided optical test cartridge allows you to monitor the performance of the optical system over time IMPORTANT Keep a permanent record of the res
22. the bar code faces right Insert the reagent cartridge into the cartridge compartment until a subtle snap is heard felt HINT The cartridge is designed to fit only one way into the instrument Do not force cartridge into instrument Insert plunger into hole in top of capillary holder Depress plunger into capillary holder fully Plunger will lock into the capillary holder Press AN High temperature part A Huom Kuumenee k ytett ess E E Q Using a smooth slow continuous motion pull flexible pull tab completely out of reagent cartridge Close door Dispose of flexible pull tab e Five 5 seconds after the door is closed a beep sounds and the assay begins NOTE If you accidentally close the door before you pull the flexible tab you have 5 seconds to re open the door the display returns to LOAD CARTRIDGE You may now pull the tab or correct existing problem s continued on next page 5 9 N OPERATING INSTRUCTIONS OPERATING INSTRUCTIONS MICROALBUMIN CREATININE DISPLAY WHAT YOU DO TEST IN PROGRESS 001 6 MIN 10 15AM colon does not blink After test is completed A 102mg L C 141mg dL 11 A C 72 001 10 17AM colon does not blink 12 5 10 Record the displayed result before removing cartridge NOTE If creatinine units are mg dL then the Albumin Creatinine A C ratio is reported as mg g If the creatinine units are mm
23. the capillary tube from the urine specimen If the urine flows back down the tube re immerse the capillary tube in the urine specimen again allowing enough time to ensure that the starch plug becomes saturated B If filling capillary tube with urine from a container with a small sample volume Immerse the tip of the capillary tube in the urine specimen Tilt sample container and capillary holder to a more horizontal position to increase the rate of flow into the capillary Take care not to spill the urine specimen NE UI Es 2 Allow enough time for the urine specimen to flow into the capillary tube and come in contact with the starch plug Wetting the starch plug seals the capillary tube and keeps the urine within the tube 3 Remove the capillary tube from the urine specimen If the urine flows back down the tube re immerse the capillary tube in the urine specimen again allowing enough time to ensure that the starch plug becomes saturated Revised 6 03 2 Using a lint free tissue carefully wipe the outside of the glass capillary tube Do not allow the tissue to touch the open end of the glass capillary Contact with the open end of the capillary tube could result in loss of sample by wicking into tissue If sample loss is obvious discard the capillary holder then repeat procedure using a new capillary holder 3 Inspect the glass capillary tube for the presence of bubble s If bubbles are obvious discard t
24. the power switch was set to ON I 1 Set the power switch to OFF O E 5 the instrument detected use of a defective d 2 Remove the program card program card 3 Plug a replacement program card into the instrument Refer to Section 9 SERVICE INFORMATION for instructions on where to order replacement program card 4 Set the power switch to ON I If the problem persists contact Bayer HealthCare Customer Service Department See Section 9 Service Information When the power switch was set to ON T Set the power switch to OFF O E 6 the instrument detected an error in Exp Contact Bayer HealthCare Customer system timing Service Department See Section 9 Service Information Revised 6 03 6 5 ON ERROR AND WARNING MESSAGES ERROR CODES amp TROUBLESHOOTING ERROR AND WARNING MESSAGES ERROR CODES AND TROUBLESHOOTING ERROR CODE 101 Buffer Reading Out of Limits High CAUSE No cartridge present Optical alignment problem SOLUTION Repeat test with cartridge in place If problem persists contact Bayer HealthCare Customer Service Department See Section 9 Service Information 102 Buffer Reading Out of Limits Low Condensation on cartridge cartridge not allowed to warm up Cartridge not located properly in instrument Buffer tab not pulled Buffer tab removed before cartridge inserted Cartridge defect in optical window Cartridge optical window blocked or dirty
25. 12 4 13 IMPORTANT If sample analysis does not begin within 5 minutes after filling glass capillary discard capillary If capillary is in the reagent cartridge discard both capillary and reagent cartridge N WARNING POTENTIAL BIOHAZARD All products or objects which come into contact with human blood even after cleaning should be handled as if capable of transmitting viral diseases The user should follow the recommendations for prevention of blood borne transmissible diseases in healthcare settings as recommended for potentially infectious human blood specimens in National Committee for Clinical Laboratory Standards Protection of Laboratory Workers from Instrument Biohazards and Infectious Disease Transmitted by Blood Body Fluids and Tissues Approved Guideline NCCLS Document M29 A ISBN 1 56238 339 6 NCCLS 940 West Valley Road Suite 1400 Wayne Pennsylvania 19087 1898 USA 1997 This document has complete information on the topic of user protection and can be used as background material for instruction YN VAROITUS MAHDOLLINEN TARTUNTAVAARA Terveydenhoitohenkil kunnan joka k ytt tata laitetta useiden ihmisten tutkimiseen tulee ottaa huomioon ett kaikki tuotteet jotka joutuvat kosketukseen ihmisveren kanssa ovat my s puhdistuksen j lkeen mahdollisia viirustartuntal hteit Tartuntojen v ltt miseksi suosittelemme laboratorion omien turvallisuusohjeiden ehdotonta noudattamista Revised 6 03 4 5 p
26. CALL PREVIOUS TESTS press O once anytime during recall of test results To exit the MENU press twice 09 13 02 010 10 24 example e Albumin A creatinine C and the albumin creatinine ratio A C results for the same specimen OR are shown sequentially on separate displays and are labeled with the same sequence number optional and date time C 72 1mg dL LOT 0325 09 13 02 010 10 24PM example OR A C 76 LOT 0325 02 24 03 010 10 24PM example NO MORE RESULTS STORED This display is retained until IN INSTRUMENT a calibration card bar code is read EH or is pressed after all results are displayed E is pressed the display returns to the first test result previously recalled this is the result for the most recent sample assayed If is pressed once the display returns to RECALL PREVIOUS TESTS If is pressed twice you exit the MENU Revised 6 03 3 3 MENU SET SEQUENCE NUMBER optional DISPLAY WHAT YOU DO WAIT WARMING UP 02 24 03 2 09PM DI 2 Press Q3 d NOTE If a sequence number is selected while a test is in progress the sequence number for the test in progress READY SCAN BAR CODE is changed to the newly selected sequence number 02 24 03 2 09PM OR TEST IN PROGRESS 001 6 MIN 10 15AM 2 SET SEQUENCE NUMBER 3 Press 8 SET SEQUENCE NUMBER 4 Saag Press or Y to select the digit above the cursor Press Er to move cursor right to ne
27. ETTING ACQUAINTED AND SET UP UNPACKING GETTING ACQUAINTED AND SET UP OPTIONS All available settings are shown in the following chart e Review this chart before you decide to accept or change the factory setting for each option An asterisk marks factory settings OPTION SETTING NUMBER DEFINITION OF SETTING NUMBER T Time 1 AM PM Format 2 24 hour format D Date 1 Month Day Year Format 2 Day e Month eYear 3 Year Month Day L Labels displayed 0 No labels with results 1 Sequence number reset daily automatically at midnight 2 Sequence number continuous 001 999 3 Time assay began 4 Time assay began sequence number reset daily automatically at midnight 5 Time assay began sequence number continuous 001 999 C Controls 0 DCA 2000 Controls only The control bar code card enables the instrument to label the control result The control result is then stored in the control memory separate from patient results 1 ANY CONTROL e f using controls other than DCA 2000 Controls use the MENU just prior to each control assay to label the control result The control result once labeled 1s stored in the control memory IMPORTANT When the MENU is used to label control results only the next sample analyzed is labeled and stored in the control memory 2 8 Revised 6 03 OPTION SETTING NUMBER DEFINITION OF SETTING NUMBER P Computer Port 0 OFF Computer por
28. ETTING THE DATE AND TIME Use the following keys 4 and Y To cycle through each available setting e g digits for day month year and time or AM PM To move cursor under setting you desire to change e g 2 in display below is marked by cursor and indicates 26 is ready for change SET DATE TIME 02 24 03 6 20AM To set the displayed date and time in the instrument DISPLAY WHAT YOU DO SET DATE TIME 02 24 03 A HEN The display on your instrument is displaying the date and time in your chosen format 1 Press 4 or until the correct two digits are displayed Press 6 SET DATE TIME 02 24 03 6 20AM 2 Press 4 or 3 until the correct two digits are displayed Press SET DATE TIME 02 24 03 6 20AM 3 Press 4 or 3 until the correct two digits are displayed Press E 2 14 Revised 6 03 DISPLAY WHAT YOU DO SET DATE TIME 02 24 03 6 20AM 4 Press or 3 until the correct two digits are displayed AM or PM if AM PM Press 69 format is selected 5 Press or 3 until the correct two digits are displayed SET DATE TIME 02 24 05 6 20AM If 24 HR format is selected press AM or PM if AM PM T If AM PM format is selected press format is selected Then press t or until the correct choice is displayed Press 9 Revised 6 03 2 15 N UNPACKING GETTING ACQUAINTED AND SET UP UNPACKING GETTING ACQUAINTED AND SET UP SETTING CREATIN
29. ICA 20004 Analyzer 2003 Bayer HealthCare LLC All Rights Reserved Printed in U S A Unless otherwise noted all 9 Trademarks are the property of Bayer HealthCare LLC Bayer Bayer HealthCare LLC Subsidiary of Bayer Corporation Elkhart IN 46514 USA Bayer Diagnostics Europe Ltd C Ec nep Chapel Lane Swords Co Dublin Ireland 50241739 ii Revised 6 03 TABLE OF CONTENTS SECTION 1 Introduction Page System and Intended Use xa isis ete intpp epe dx d RM NR RE pA i eR E ec 1 1 Features m 1 1 MSN ERI m 1 1 PA AZ ATS sata ti ol SI dd di ceed E ANS 1 1 Safety standards ae AA A E a i 1 1 A O a a a ule oce de TO parois 1 2 SECTION 2 Unpacking Getting Acquainted and Set Up A ote bc ene Eoi rre ELO LL tup adt Re i acido c yeas 2 1 Carton Contents da AAA duree sse eva led es we en wav AAA 2 1 Getting Acquainted DCA 2000 Analyzer Front Panel seseeeseeeeseeeleeleesele se enne 22 DCA 2000 Analyzer Back Panel ei AA A bI T RUE MS 2 3 Sereen SAVER NAM EM II P 2 3 Audible TONES oer A e a MEE EM EEEE 2 3 Blinking Colon in Displayed Time 0 0 cece eee eee ence nen een ene n entrees 2 3 When To Turn the Power Off iii Ra RE RETE Ea ele P e Ea 2 3 Set Up Placing the Instrument Connecting the Power Cord Inserting Program Card L 2 4 Checking to Verify Instrument Functions Properly 0 cece cece cece een een ences 2 5 Wie wine Factory Settings
30. INE CONCENTRATION UNITS Microalbumin Creatinine Assay ONLY The concentration units reported for creatinine are selectable between mg dL and mmol L The factory setting is mg dL DISPLAY READY SCAN BAR CODE 02 24 03 2 09PM SET CREATININE UNITS mg dL SET CREATININE UNITS mg dL SET CREATININE UNITS mmol L SET CREATININE UNITS mmol L 2 16 WHAT YOU DO 1 Press 62 2 Repeatedly press until SET CREATININE UNITS is displayed ec 3 Press This places a cursor below the m in mg dL and the question mark disappears 4 Press 4 or 3 to display mmol L or mg dL 5 Press 9 to accept desired units 6 Press O to exit the MENU Revised 6 03 RUNNING THE OPTICAL TEST CARTRIDGE Standard 1 Prior to Analyzing Samples for the First Time The provided optical test cartridge allows you to monitor the performance of the optical system over time The optical test cartridge holds the cartridge return spring in place and also simulates the mass of a reagent test cartridge Before samples are analyzed for the first time run the optical test cartridge IMPORTANT Keep a permanent record of the results obtained i e Mean Transmittance Standard Deviation and Drift These initial values will be used for comparison as in control charting and also to isolate the cause of an instrument malfunction in conjunction with instructions provide
31. ING KEEP DOOR CLOSED WAIT WARMING UP 02 24 03 2 09PM 2 OPTIONAL While the instrument is warming up usually 1 2 minutes but can take up to 8 minutes you may access certain MENU items Refer to Section 3 for instructions Reminder Current time is denoted by blinking colon Time assay began is denoted READY SCAN BAR CODE by stationary colon 02 24 03 2 09PM a beep is heard Revised 6 03 4 1 p ITY NICO TOOWAH SNOLLONULSNI ONILVUAdO OPERATING INSTRUCTIONS HEMOGLOBIN Ate STEP 2 Calibration When to Calibrate NOTES Calibrate the System for each new lot number of The instrument stores up to two calibrations reagent cartridges for the DCA 2000 Hemoglobin Aic Reagent Materials Required Test The two calibrations must be for two Calibration Card provided in DCA 2000 different lot numbers Hemoglobin Aj Reagent Kit The calibration stored in the instrument first is deleted when a calibration card for a third lot number is scanned DISPLAY WHAT YOU DO READY SCAN BAR CODE 02 24 03 2 09PM 1 Locate the dot on the instrument next to the bar code track OR 2 Locate the bar code on the calibration card 3 Hold the card so that the bar code faces right Any result or menu display 4 Insert the card into the bar code track above as long as testing is not in progress dot Hold card gently against the right side of track Mery ms amp 4 my E eum 5 Quickly within 1
32. Oly NIJO TOOWAH SNOILONALSNI ONILVAAJO OPERATING INSTRUCTIONS HEMOGLOBIN Ate FILLING THE CAPILLARY WITH WHOLE B If filling glass capillary with blood BLOOD continued obtained by venipuncture 1 Complete step A OR step B depending upon the blood sample source Continue with step 2 1 Mix sample well by inversion or use of on the next page an aliquot mixer to prevent separation IMPORTANT Do not allow blood to contact of red blood cells and plasma the plastic part of the capillary holder Any blood touching the plastic will be transferred 2 Remove stopper from blood collection into the reaction buffer along with the blood in the glass capillary This can cause an invalid HbA result or possibly an error message If blood contacts the plastic part of the tube in such a way that a small sample of blood remains on stopper capillary holder discard capillary holder 3 Hold the capillary holder at an angle A If filling glass capillary with blood from 4 Touch only the tip of the capillary to finger prick blood sample on stopper 1 Hold the capillary holder at an angle Do not attempt to fill capillary by touching glass capillary to blood in a blood collection tube Attempting to fill capillary in this manner most often results in blood touching the capillary holder If blood touches the capillary holder discard capillary holder 2 Touch only the tip of the capillary to a small drop of blood on the finger until th
33. PLAY WHAT YOU DO READY SCAN BAR CODE 02 24 03 2 09PM 3 The test 1s cancelled e Scan bar code displayed if the test is cancelled after the bar code is scanned but before the cartridge compartment door is opened a beep is heard OR OR Open cartridge compartment door and CANCELLED DISCARD TEST remove cartridge 02 24 03 10 18AM displayed if the test is cancelled during sample analysis cartridge is in instrument an error buzz is heard z E 5 S 5 16 Revised 6 03 ERROR AND WARNING MESSAGES ERROR CODES AND TROUBLESHOOTING Revised 6 03 Use the chart below to quickly find the correct page for the desired error and warning message error code or troubleshooting information ERROR AND WARNING MESSAGES Error and warning messages are provided in alphabetical order page CANCELLED DISCARD TEST date time 6 2 DOOR OPEN ERROR 2 0 ccccccessccessseceeeceeseceecsscecesseecnseecenteeeeeas 6 2 OUT OF DATE CONTROL eese 6 2 OUT OF DATE REAGENT esee rennen 6 2 PEEASE WAIT inci tad ctr e de ias 6 2 SCAN CALIBRATION CARD eene 6 2 SEE OPERATING MANUAL COMPUTER PORT ERROR Dina RIDERE 6 2 SEE OPERATING MANUAL ERROR 90 RAM MEMORY 6 SEE OPERATING MANUAL TEST ERROR XXX 6 3 SEE OPERATING MANUAL ERROR XX eese 6 3 SEE OPERATING MANUAL TEST UNKNOWN
34. ROL RESULTS If is pressed twice you exit the MENU Revised 6 03 3 7 MENU VIEW CALIBRATION STATUS The instrument stores up to two calibrations for each DCA 2000 Reagent Test The two calibrations must be for two different lot numbers DISPLAY WHAT YOU DO WAIT WARMING UP 02 24 03 2 09PM 1 Press 69 A test in progress is not aborted OR PEARY I TA CANTERR STOLE 2 Repeatedly press until 02 24 03 2 09PM VIEW CALIBRATION STATUS is OR displayed TEST IN PROGRESS 001 6 MIN 10 15AM fp VIEW CALIBRATION STATUS O e The calibration status for the most recent calibration is displayed first 3 8 Revised 6 03 DISPLAY WHAT YOU DO LOT 0183 HbA1c 02 24 03 11 23PM 4 Press to recall status of each calibration stored example OR NOTES To return display to VIEW CALIBRATION LOT 0222 Malb C STATUS press once anytime during calibration 02 24 03 11 30PM status recall To exit the MENU press twice example NO MORE CALIBRATIONS STORED IN INSTRUMENT This display is retained until e a bar code is scanned after all stored or is pressed calibrations are displayed If E gt is pressed the display returns to the first calibration status previously recalled this is the status for the most recent calibration If is pressed once the display returns to VIEW CALIBRATION STATUS If is pressed twice you exit the MENU Revised 6 03 3 9 MEN
35. RTRIDGE 4 Insert the tip of a straightened paper clip or other like device into the top hole on COMPARTMENT eae j e Gently pull metal end toward center of N WARNING Turn off the power and cartridge compartment to release one side of unplug the power cord before cleaning the spring from the cartridge holder the cartridge compartment Repeat procedure to release other side of spring from cartridge holder VAROITUS Kytke virta pois ja irrota virtajohto ennen kuin puhdistat 5 Pull cartridge return spring completely out of kasettipes n instrument Do not allow liquid to drip into instrument 6 Clean cartridge return spring using any of the If liquid drips into instrument optics can be following destroyed e warm solution of mild detergent and water you may immerse cartridge return spring l T cartridge compartment door as far as e lint free cloth dampened in water or ethanol ae IMPORTANT Make sure the leaf springs are 2 Using a lint free cloth dampened with water not bent or damaged while cleaning Damaged or ethanol wipe the inside surface of the leaf springs will not function properly compartment door and surfaces on both sides of the cartridge holder Dry surfaces using a clean dry lint free cloth 3 Locate the cartridge return spring inside the cartridge holder Note top and bottom holes LEAF SPRINGS HIGH TEMPERATURE PART TOP HOLE CAE 7 Dry cartridge return spring with a
36. RUN CONTROL optional Available only if selected via INSTRUMENT SETUP procedure e Marks the control result with a lower case c lower case c indicates controls other than DCA 2000 Controls unless a DCA 2000 Control was analyzed without scanning the control bar code card provided with the control kit DISPLAY WHAT YOU DO READY SCAN BAR CODE 02 24 03 2 09PM 1 Press 2 Repeatedly press until RUN CONTROL is displayed RUN CONTROL 3 Press SET CONTROL NUMBER 4 Press 4 or until the desired c control number choices 1 9 is displayed Press SCAN BAR CODE 02 24 03 c4 41 10AM 5 Follow instructions in Section 4 page 4 3 or Section 5 page 5 4 under Preparing Patient Samples and Controls Revised 6 03 3 17 OPERATING INSTRUCTIONS HEMOGLOBIN A1c NOTE The instructions in this section are for use after INSTRUMENT SETUP has been performed a one time requirement upon receipt of a new or factory serviced instrument STEP 1 Turning the Power ON DISPLAY WHAT YOU DO 1 Set the power switch to ON IMPORTANT The program card must be inserted or removed only when the power switch is set to OFF If the card is inserted when the power is ON the card can be After about 8 seconds permanently damaged SOFTWARE VERSION E3 11 01 04 displayed for 8 seconds COPYRIGHT 1991 2003 BY BAYER CORPORATION displayed for 3 seconds INITIALIZ
37. Repeatedly press until RECALL OR CONTROL RESULTS is displayed READY SCAN BAR CODE 02 24 03 2 09PM OR TEST IN PROGRESS Test in progress is not aborted 001 6 MIN 10 15AM RECALL NTROL RESULTS ES SUE 3 Press The control result for the control most recently assayed is displayed first 3 6 Revised 6 03 DISPLAY WHAT YOU DO 9 8 HbAlc LOT 0325 02 24 03 C1 LOTC 0223 4 Press to recall up to 16 control results example OR NOTES To print the control result press e if a printer is in use A 24 6m g L LOT 0105 If e 1s pressed for more than 3 seconds all stored 02 24 03 C2 LOTC 0345 control results are printed To return display to RECALL CONTROL example RESULTS press once anytime during recall of results To exit the MENU press twice OR e Albumin A and creatinine C for the same control are shown sequentially on separate displays and are labeled with the same date C 54 1mg dL LOT 0105 02 24 03 C2 LOTC 0345 example Reminder Upper case C indicates result for a DCA 2000 Control NO MORE CONTROLS STORED IN INSTRUMENT This display is retained until a bar code is scanned after all control or is pressed results are displayed If is pressed the display returns to the first control result previously recalled this is the result for the most recent control assayed If is pressed once the display returns to RECALL CONT
38. U SET DATE TIME Use the following keys 4 and Y To cycle through each available setting e g digits for day month year and time or AM PM To move cursor under setting you desire to change e g 2 in display below is marked by cursor and indicates 26 is ready for change SET DATE TIME 02 24 03 6 20AM To set the displayed date and time in the instrument DISPLAY WHAT YOU DO WAIT WARMING UP 02 24 03 2 09PM l Press E 2 Repeatedly press amp until OR SET DATE TIME is displayed READY SCAN BAR CODE 02 24 03 2 09PM SET DATE TIME 3 P 02 24 03 6 19AM dcr 3 10 Revised 6 03 DISPLAY WHAT YOU DO SET DATE TIME da tes 02 24 03 6 20AM The display on your instrument is displaying the date and time in your chosen format 4 Press 4 or until the correct two digits are displayed Press SET DATE TIME 5 Press 4 or 3 until the correct two digits are 02 24 03 6 20AM displayed Press 6 SET DATE TIME 6 Press 4 or 3 until the correct two digits are 02 24 03 6 20AM displayed Press The cursor will move back to the first digit of the date 7 Press to advance the cursor to the time setting SET DATE TIME 02 24 03 6 20AM 8 Press 4 or 3 until the correct two digits are displayed AM or PM if AM PM Press D format is selected i SET DATE TIME 9 Press 4 or 3 until the correct two digits are 02 24 03 6 20AM disp
39. action releases unlocks cartridge 4 Pull test cartridge out of compartment 5 Put test cartridge aside for later use page 2 17 6 Make sure the cartridge return spring inside the cartridge compartment is intact refer to Section 7 page 7 4 for information regarding this spring 2 2 GETTING ACQUAINTED DCA 2000 Analyzer FRONT PANEL Display indicates date time error messages test results procedural prompts etc Keys allow you to provide input for system set up menu items etc Reagent Cartridge Compartment Access Door covers and protects the reagent cartridge closing door starts test timing after a 5 second delay Reagent Cartridge Compartment holds one reagent cartridge during sample analysis Bar Code Reader Window covers and protects the bar code reader 6 Bar Code Track area where reagent cartridge calibration card or control card is placed prior to scanning bar code Revised 6 03 BACK PANEL Power Switch turns the power to the instrument ON and OFF Filter Holder contains replaceable air filter that prevents dust contamination E Program Card Connector accepts the program card EIA 232 D Output accepts the plug for the computer interface cable EB Printer Output accepts the plug for the printer cable Power Cord Connector accepts the plug for connecting the power cord to the instrument E Fuse Holder Compartment holds
40. agent Cartridge IMPORTANT Do not use scissors to cut open foil package Scissors can damage the reagent cartridge the flexible pull tab on the cartridge or the sack containing desiccant 1 Remove one foil package containing a reagent cartridge from storage 2 Refer to Recommended Procedures for Handling Reagent Cartridges in the DCA 2000 Microalbumin Creatinine Reagent Kit package insert for instructions on how and when to open foil package 54 INSPECTING THE CONTENTS OF THE FOIL PACKAGE The foil package contains 1 reagent cartridge with flexible pull tab and bar code label 2 small sack filled with desiccant When handling the reagent cartridge do not touch or otherwise contaminate the optical window or erroneous test results may occur Discard the reagent cartridge if the cartridge is damaged the flexible pull tab is loose or missing the small sack desiccant is missing or open loose desiccant particles are found inside the foil package refer to Service Information Section 9 Revised 6 03 CAPILLARY HOLDER AND PLUNGER Unused capillary holders may be saved and used with any lot of microalbumin creatinine reagent cartridges 1 Remove a capillary holder and plunger from plastic bag 2 Inspect the capillary holder for the presence of absorbent pad glass capillary latching mechanism ES starch plug 3 If the capillary holder is missing any of the above parts discard the c
41. alyzing DCA 2000 Hemoglobin Aj Controls use instructions that contain steps for scanning the control bar code card found on pages 4 12 4 14 e If using controls other than DCA 2000 Hemoglobin Aj Controls refer to Section 3 page 3 17 for information on labeling and storing the control result WHAT YOU DO 1 Locate the dot on the instrument next to the bar code track 2 Locate the bar code on the control card NOTE The control card is double sided one side for normal the other for abnormal Make sure you are using the correct side of the control card for the particular DCA 2000 Control level in use Cl Normal C2 Abnormal 3 Hold the control card so that the bar code faces right 4 Insert the control card into the bar code track above dot Hold card gently against the right side of track 5 Quickly within 1 sec and smoothly slide the card down past the dot A beep sounds to signal a successful scan f no beep sounds repeat procedure If a beep repeatedly fails to sound refer to Troubleshooting Section 6 6 Press Revised 6 03 DISPLAY SCAN BAR CODE HbA1c 02 24 03 C1 11 10AM LOAD CONTROL PULL TAB CLOSE DOOR Revised 6 03 WHAT YOU DO 7 8 10 11 12 13 14 Locate the bar code on the reagent cartridge Hold the reagent cartridge so that the bar code faces right Insert the reagent cartridge above dot into bar code track Quickly within
42. apillary holder also discard if the starch plug is at the bottom of the capillary tube PA refer to Service Information Section 9 Revised 6 03 5 5 N SNOILONALSNI ONLLVAAJO N OPERATING INSTRUCTIONS OPERATING INSTRUCTIONS MICROALBUMIN CREATININE FILLING THE CAPILLARY WITH URINE 1 Complete step A OR step B depending upon Instructions for filling capillary with control sample are found in the DCA 2000 Microalbumin Creatinine Control package insert the volume of urine specimen available Continue with Step 2 on the next page IMPORTANT Do not allow urine to contact either the plastic part of the capillary holder or the adsorbent material in the capillary holder Any urine touching the plastic will be transferred into the reaction buffer along with the urine in the glass capillary This can cause an invalid microalbumin creatinine result or possibly an error message If urine contacts the plastic part of the capillary holder discard capillary holder A If filling capillary tube with urine from a container with a large sample volume 1 Immerse the tip of the capillary tube in the urine specimen to a level just above the plug in the capillary Ie 2 Allow enough time for the urine specimen to flow into the capillary tube and come in contact with the starch plug approximately 5 seconds Wetting the starch plug seals the capillary tube and keeps the urine within the tube 3 Remove
43. artridge into instrument Insert plunger into hole in top of capillary holder Depress plunger into capillary holder fully Plunger will lock into the capillary holder Press Using smooth slow continuous motion pull flexible pull tab completely out of reagent cartridge Close door Dispose of flexible pull tab NOTE If you accidentally close the door before you pull the tab you have 5 seconds to re open the door the display returns to LOAD CARTRIDGE You may now pull the tab or correct existing problem s continued on next page 5 13 Un SNOILIMALSNI DNILVAAJO N OPERATING INSTRUCTIONS OPERATING INSTRUCTIONS MICROALBUMIN CREATININE DISPLAY 5 14 PROCESSING CONTROL C1 Malb C 7 MIN 11 11AM colon does not blink After test is completed For a result within the acceptable control range printed in the control package insert A 102mg L C 141 mg dL C1 11 11AM NOTE The albumin creatinine ratio is not calculated for controls 16 OR For a result outside the acceptable control range printed in the control package insert CONTROL OUT OF RANGE 17 PRESS CESC TO PROCEED WHAT YOU DO NOTE If CONTROL OUT OF RANGE is displayed press amp to display value of out of range control Record the displayed result before removing cartridge Remove cartridge a Open cartridge compartment door b Locate the button on the right side of the cartridge compartment
44. ature and or humidity Ensure proper storage of reagent kits Open foil package just prior to use of cartridge 513 Irregular Reaction Kinetics for Creatinine Cartridge exposed to excessive temperature and or humidity Particulate contamination Ensure proper storage of reagent kits Open foil package just prior to use of cartridge If problem persists contact Bayer HealthCare Customer Service Department See Section 9 Service Information 515 Normalization Factor has not been set Instrument has not been adjusted to run the Microalbumin Creatinine assay Contact Bayer HealthCare Customer Service Department See Section 9 Service Information 516 Normalization Factor outside allowable range Normalization Cartridge is not located properly in instrument Normalization Cartridge is dirty or defective Ensure that cartridge is inserted completely into instrument If problem persists contact Bayer HealthCare Customer Service Department See Section 9 Service Information Revised 6 03 6 9 ERROR AND WARNING MESSAGES ERROR CODES AND TROUBLESHOOTING TROUBLESHOOTING PROBLEM SOLUTION Beep repeatedly fails to sound after scanning a bar code 1 Insert the cartridge or expanded bottom of card whichever applies into the bar code track below the dot 2 Quickly within 1 second and smoothly slide the card or cartridge up past the dot If a beep continually fails to
45. clean lint free cloth Set spring aside 1 eN BOTTOM SPRING HOLE i 7 4 Revised 6 03 8 Using a clean dry sponge swab provided in Cleaning Kit Part No 95001901 remove spilled liquid from the cartridge holder IMPORTANT Do not use a cotton swab Cotton fibers may be left on surface and interfere with instrument optical system With compartment door partially closed rotate the cartridge holder as shown to locate and remove any additional liquid NOTE Cartridge holder cannot be rotated if compartment door is completely open 9 Dampen do not soak a sponge swab with water or ethanol Clean cartridge holder rotating cartridge holder as necessary IMPORTANT Do not allow liquid to drip off sponge swab into instrument If liquid drips into instrument optics can be destroyed Revised 6 03 10 11 13 Look inside the cartridge compartment and locate the vertical grooves tracks Next locate the front and back slots found near the top lip of the compartment Locate the leaf spring on one side of the cartridge return spring With the leaf spring orientated toward the back of the instrument lower the leaf spring into the instrument as follows a Hold onto both sides of the cartridge return spring near the holes b Pinch the sides together push toward each other and lower the spring into instrument by sliding the sides of the spring between the vertical grooves tracks in
46. cord to a properly grounded CONNECTING THE POWER CORD outlet INSERTING PROGRAM CARD 6 Move the instrument into place on the IMPORTANT Do not place the instrument designated work space where it would be subjected to extreme e Allow at least 2 inches of air space between temperature variations direct sunlight the wall or other surface and the back and excessive humidity or air current or excessive right sides of the instrument ventilation particulate matter panels Place the instrument on a firm level surface near a properly grounded electrical outlet f the surface is not level the instrument will not function properly 2 Set power switch to OFF O 3 Plug in program card contacts facing instrument label side up IMPORTANT The program card can be damaged if inserted when the power is ON I 2 4 Revised 6 03 CHECKING TO VERIFY INSTRUMENT FUNCTIONS PROPERLY Set the power switch to ON I e After about 8 seconds the software version is displayed SOFTWARE VERSION E3 11 01 04 displayed for about 8 seconds Copyright information is displayed for 3 seconds COPYRIGHT 1991 2003 BY BAYER CORPORATION e Then INITIALIZING KEEP DOOR CLOSED The instrument is checking internal optics and proper operation of mechanical features e Then INSTRUMENT SETUP PRESS C lt TO CONTINUE Instrument does not function Above display s fail s to appear Contact the nearest Bayer
47. d by our Bayer HealthCare Customer Service Department Representative t is recommended that you record the results on the page provided in the appendix of this manual DISPLAY READY 02 24 03 SCAN BAR CODE 2 09PM RUN STANDARD 1 Revised 6 03 After the optical test cartridge is run initially it is recommended that the optical test cartridge be run e quarterly after cleaning the cartridge compartment e after changing the air filter when instructed to do so by our Customer Service Representative NOTE Refer to Section 7 page 7 6 Instrument Care and Routine Maintenance for information regarding the comparison of initial values obtained for your instrument with values obtained thereafter WHAT YOU DO 1 Locate the bar code on the optical test cartridge 2 Hold the cartridge so that the bar code faces right 3 Insert the cartridge above dot on instrument into the bar code track 4 Quickly within 1 second and smoothly slide the cartridge down past the dot A beep sounds to signal a successful scan f no beep sounds repeat the procedure If a beep repeatedly fails to sound refer to Troubleshooting Section 6 5 Press 2 17 N dN LAS ANV G amp LNIVAOOV SNILL39 9NDIOVdNn N UNPACKING GETTING ACQUAINTED AND SET UP UNPACKING GETTING ACQUAINTED AND SET UP DISPLAY STANDARD 1 LOAD CLOSE DOOR PROCESSING STANDARD S1 6 MIN 10 02AM 6 MIN total test time
48. dL 1 33 mmol L then no ratio will be reported All laboratory tests are subject to random error If the test result is questionable or if clinical signs and symptoms appear inconsistent with the test results re assay the sample or confirm the result using another method 5 11 Un SNOLLONULSNI ONLLVAAJO N OPERATING INSTRUCTIONS OPERATING INSTRUCTIONS MICROALBUMIN CREATININE Analyzing DCA 2000 Microalbumin Creatinine Controls ONLY NOTE Follow instructions on page 5 8 if analyzing a recommended control other than a DCA 2000 Microalbumin Creatinine Control Controls are analyzed in the same manner as the patient sample A specially designed control bar code that enters the control lot number etc is provided with DCA 2000 Microalbumin Creatinine Controls DISPLAY READY SCAN BAR CODE 02 24 05 2 09PM RUN CONTROL C1 LOTC 1112 Malb C 5 12 Therefore when analyzing DCA 2000 Microalbumin Creatinine Controls use instructions that contain steps for scanning the control bar code card found on pages 5 12 5 14 If using controls other than DCA 2000 Microalbumin Creatinine Controls refer to Section 3 page 3 17 for information on labeling and storing the control result WHAT YOU DO 1 Locate the dot on the instrument next to the bar code track 2 Locate the bar code on the control card NOTE The control card is double sided one side for Low the other for High Make
49. dot A beep sounds to signal a successful scan e f no beep sounds repeat procedure If a beep repeatedly fails to sound refer to Troubleshooting Section 5 i 4 8 Revised 6 03 DISPLAY WHAT YOU DO LOAD CARTRIDGE PULL TAB CLOSE DOOR 6 Open the cartridge compartment door 7 Hold the reagent cartridge so that the bar code faces right Insert the reagent cartridge into the cartridge compartment until a subtle snap is heard felt N High temperature part A Huom Kuumenee k ytett ess b f YY HINT The cartridge is designed to fit only on way into the instrument Do not force cartridge into instrument 8 Using a smooth slow continuous motion pull flexible pull tab completely out of reagent cartridge 9 Close door Dispose of flexible pull tab Five 5 seconds after the door is closed a beep sounds and the assay begins NOTE If you accidentally close the door before you pull the flexible plastic tab you have 5 seconds to re open the door the display returns to LOAD CARTRIDGE You may now pull the tab or correct existing problem s Revised 6 03 4 9 OPERATING INSTRUCTIONS HEMOGLOBIN Ate AAA DISPLAY WHAT YOU DO TEST IN PROGRESS 001 6 MIN 10 15AM colon does not blink After test is completed 9 8 CADANG 10 Record the displayed result before removing ad 001 10 21 the reagent cartridge colon does not blink 11 Remove the reagent cartridge
50. e capillary is filled 4 6 Revised 6 03 2 Using a lint free tissue carefully wipe the outside of the glass capillary Do not allow the tissue to touch the open end of the glass capillary Contact with the open end of the capillary could result in loss of sample by wicking into tissue If sample loss is obvious discard capillary holder then repeat procedure using a new capillary holder 3 Inspect the glass capillary for the presence of bubble s If bubble s are obvious discard capillary holder then repeat procedure using a new capillary holder 4 Position the capillary holder in the correct orientation for insertion into the reagent cartridge 5 Carefully insert the capillary holder into the reagent cartridge until the holder gently snaps into place IMPORTANT Avoid harsh insertion of capillary holder It is important not to dislodge sample from glass capillary or erroneous results may occur Revised 6 03 4 7 OPERATING INSTRUCTIONS HEMOGLOBIN Ate STEP 4 Analyzing the Patient Sample DISPLAY WHAT YOU DO READY SCAN BAR CODE 1 Locate the dot on the instrument next to the 02 24 03 2 09PM bar code track 2 Locate the bar code on the reagent cartridge 3 Hold the reagent cartridge so that the bar code faces right 4 Insert the reagent cartridge above dot into bar code track an y ES 5 Quickly within 1 sec and smoothly slide the reagent cartridge down past the
51. e ee ence nen eenees 4 3 Step 4 Analyzing the Patient Sample asistida 4 8 Analyzing DCA 2000 Hemoglobin A c Controls ONLY 2 cece cece eee nen eens 4 12 Camcelling a Tes eee etna rap ee tte COR eat cce Rute vire ecu delude esu ud le Ga pfe 4 15 SECTION 5 Operating Instructions Microalbumin Creatinine Page Step Turne tlie Power Dlls its coco torret bio Hob bekam Ro cereis 5 1 Step Ze Calibrations ser aa a a a tN uu a lake a UE LIE Lol du edunt 5 2 Step 3 Preparing Patient Samples and Controls esee 5 4 Step 4 Analyzing the Patient Sample ooi deo eue Ede A ae els ret roy ad bd ded 5 8 Analyzing DCA 2000 Microalbumin Creatinine Controls ONLY 0 0 cece eee eee ene ee 5 12 Cancelling d POSE natat A Ah eA acti tta re roce ac e AS oda em AL de Ro doe 5 15 SECTION 6 Error and Warning Messages Error Codes and Troubleshooting Chart of Contents sourien r E EESE mela eee E EE Hp EEEE epa hates EEA 6 1 Error and Warming Messages 10 10 ct til dd E ee cb E EU LU LU LU DIU UC 6 2 Error Codes eco dieses te ee ae Sh A A e A E MM M ME 6 4 TEOUDIESHOO IG id rd ble 6 10 SECTION 7 Instrument Care and Routine Maintenance Instr ment A ode e UE REA TUM E A ai Md tui toon Ed cte cardi eat eas gu T Routine Maintenance Chart ieee seta ins donee e x a CU E oe ee 7 1 Exterior of Instrument and Bar Code Window includes disinfection 0c cece cence Vee Changing Air Pallet oh 2424242130 to atest catch lo
52. emperature 32 C vd 15 32 C Hemoglobin Ac 30 C mi 18 30 C Microalbumin Creatinine Relative Humidity Range 10 90 RH non condensing Revised 6 03 NOTE If an instrument I O port is utilized the cable used should be 100 shielded to guard against EMI and RFI There should be continuity between the cable shield and connector shell that mates with the instrument Instrument Safety Design The instument is for professional in vitro diagnostic use and must be used in the manner specified in the Operating Manual in order to provide the safety and standard performance standards specified The instrument will operate safely in the conditions listed below however results will only be correct for the system specifications listed above indoors 5 40 C 41 104 F installation category II IEC 1010 1 safety tested to comply to IEC 1010 1 HAZARDS To alert you to potential electrical or operational hazards warning and caution statements are provided where applicable To ensure your safety comply with all warning and caution statements SAFETY STANDARDS Underwriters Laboratories Inc UL and the Canadian Standards Association CSA as certified and complies with the safety standards specified in UL 3101 and CSA C22 2 No 1010 1 The instrument meets the provisions of the VD Directive 98 79 EC Oct 1998 which includes the EMC Directive 89 336 Amendment 92 3 1 EEC and the Low Voltage Safe
53. en foil package just prior to use of cartridge If problem persists contact Bayer HealthCare Customer Service Department See Section 9 Service Information Wait no more than 5 minutes after filling capillary before starting test 6 7 ON ERROR AND WARNING MESSAGES ERROR CODES amp TROUBLESHOOTING ERROR AND WARNING MESSAGES ERROR CODES AND TROUBLESHOOTING ERROR CODE 501 Buffer Mean Out of Limits Low Absorbance CAUSE No cartridge present Optical alignment problem SOLUTION Repeat test with cartridge in place If problem persists contact Bayer HealthCare Customer Service Department See Section 9 Service Information 502 Buffer Mean Out of Limits High Absorbance Condensation on cartridge cartridge not allowed to warm up Cartridge not located properly in instrument Buffer tab not pulled Buffer tab removed before cartridge inserted Cartridge defect in optical window Cartridge optical window blocked or dirty Allow at least 15 minutes after cartridge is removed from refrigerator before starting test Ensure that cartridge is inserted completely into instrument Pull buffer tab after inserting cartridge into holder If problem persists contact Bayer HealthCare Customer Service Department See Section 9 Service Information 503 High Variation in Readings for Buffer Rare Particulate contamination If problem persists contact Bayer HealthCare Custom
54. equested information will help identify the cause of the particular problem How to Report the Problem First Record the following information Instrument Serial Number Installation Date Test Type Reagent Cartridge Lot Number Control Lot Number Control Results Optical Test Cartridge Results Initial Current Mean Transmittance Standard Deviation Drift Second Complete the following Preservice Questionnaire 1 Has Section 6 Trouble YES NO shooting been reviewed 2 Have you performed the t YES NO required maintenance procedures Section 7 Revised 6 03 3 Set the power switch to OFF YES NO Make sure the program card is securely plugged in Set the power switch to ON Are the following displayed SOFTWARE VERSION E3 11 01 04 COPYRIGHT 1991 2003 BY BAYER CORPORATION INITIALIZING KEEP DOOR CLOSED WAIT WARMING UP 02 24 03 2 09PM if instrument is not within operating temperature range READY SCAN BAR CODE 02 24 03 2 09PM 4 If displays do not appear e is the instrument plugged YES NO into a live AC electrical outlet e Is the line fuse defective YES NO Refer to Section 7 Minor Repair 5 Do any characters on the dis YES NO play appear partially defective 9 1 O NOLLVIASIOJNI HOIAIAS SERVICE INFORMATION
55. er Service Department See Section 9 Service Information 504 Sample Blank Mean Out of Limits Low Particulate contamination Repeat test If problem persists contact Bayer HealthCare Customer Service Department See Section 9 Service Information 505 Sample Blank Mean Out of Limits High Urine sample is turbid or highly pigmented Centrifuge sample before assaying if sample is very turbid or cloudy If sample contains visible amounts of blood or is highly pigmented obtain a fresh sample If problem persists contact Bayer HealthCare Customer Service Department See Section 9 Service Information 506 High Variation in Readings for Sample Blank Rare Particulate contamination Repeat test If problem persists contact Bayer HealthCare Customer Service Department See Section 9 Service Information 507 508 Readings for Albumin Out of Limits Rare Cartridge exposed to excessive temperature and or humidity Ensure proper storage of reagent kits Open foil package just prior to use of cartridge 6 8 Revised 6 03 ERROR CODE 509 High Variation in Albumin Readings CAUSE Rare Particulate contamination SOLUTION Repeat test If problem persists contact Bayer HealthCare Customer Service Department See Section 9 Service Information 510 511 Readings for Creatinine Out of Limits Rare Cartridge exposed to excessive temper
56. er factory setting for first computer port option 2 Press 4 and 3 to cycle through choices for BAUD RATE When the desired choice is displayed press moves cursor under setting for next option 3 Press 4 and 9 to cycle through choices for DATA BITS When the desired choice is displayed press moves cursor under setting for next option 4 Press 4 and 9 to cycle through choices for PARITY When the desired choice is displayed press moves cursor under setting for next option Revised 6 03 DISPLAY 1140 STOP BITS 1140 BLOCK XFER Revised 6 03 2 9821010 ONE 2 9821010 OFF 2 9821000 OFF 2 9801110 OFF WHAT YOU DO Press 4 and 9 to cycle through choices for STOP BITS When the desired choice is displayed press moves cursor under setting for next option Press 4 and 9 to cycle through choices for XON XOFF When the desired choice is displayed press moves cursor under setting for next option Press t and 9 to cycle through choices for BLOCK TRANSFER When the desired choice is displayed press moves cursor under setting for next option Press 4 and 9 to cycle through choices for MODEM Check to make sure all numbers on Line 1 represent desired settings Press accepts all settings and advances display to SET DATE TIME 2 13 NO UNPACKING GETTING ACQUAINTED AND SET UP UNPACKING GETTING ACQUAINTED AND SET UP S
57. erae ol eie uo eoe a e diu a FUE pr ina ebd 2 6 O E 2 8 Accepting Factory Setliigs ossi eoe Pod se IH Ves eee a peres der ee 2 10 Changing Factory Settings e oss osx thi pies Et eade edd ORO GOE VE AEREE exiit 2 10 setting Dateand Tie tt E E Dau EE A a deus EE ERA d 2 14 Setting Creatinine Concentration Units Microalbumin Creatinine Assay ONLY 2 16 Running the Optical Test Cartridge Standard 1 Prior To Analyzing Samples for the First Time 00 cece eee eee eee een ences 2 17 SECTION 3 Menu Me ou ducing teu se ua tu ene LA rele a x te Pis rd ede etui te Dn E ELA Lol ACA ED I Ro 3 1 RBCALIPREVIOUSSEBS ES accetto I ER EE OB RS a OR ns cau vett de 3 2 SET SEOUENCEANUMBER 300 cesta ea Gaon mh Ig e NAR NC he Rino Aaa rua ee men 3 4 RECALL CONTROL RES WEDS ra Aut dte deu de EE AE AAA Eo 3 5 VIEW CALIBRATION STATUS ceci cere te b ga ARCA LEE CE CUTE T eres 3 8 SBEDATE PAME iere Desi pe debet oet ap Reda pt p ADM RU cde a Dette is 3 10 INSTRUMENT e DE EE 3 13 SEDCREATININE UNITS ect eras A AS e OCC EO EE du 3 15 INSTRUMENTIES TT conde AU atid etae ONE DRM S VR LEE AD LEES 3 16 RUN CONTROL Ms 2 ERR NM EREER NEM EU eL LA I 3 17 Revised 6 03 ili SECTION 4 Operating Instructions Hemoglobin Aic Page Step 1 Turning the POWE ODD co eee ereoti eoe reset aiii 4 Step 2 Cabra o co betae ou urbc eben leh LU EULALIA LA duet Md 4 2 Step 3 Preparing Patient Samples and Controls 00 cece cece cece ee
58. f CONTROL OUT OF RANGE is displayed press amp to display value of out of range control Record the displayed result before removing the reagent cartridge Remove the reagent cartridge a Open cartridge compartment door b Locate the button on the right side of the cartridge compartment Push and hold it down with your right hand c With your left hand gently push the tab on the cartridge to the right this action releases unlocks cartridge d Pull the reagent cartridge out of the compartment e Discard cartridge in proper container according to your standard laboratory procedures If the door is opened within 15 minutes after assay completion the test result is displayed for only 30 seconds If the door is not opened the test result will remain displayed for 15 minutes At 15 minutes an audible tone error buzz sounds and the display changes to READY REMOVE TEST Revised 6 03 CANCELLING A TEST You may cancel a test anytime Important If a test in progress is cancelled the test must be discarded DISPLAY WHAT YOU DO LOAD CARTRIDGE PULL TAB CLOSE DOOR L Press OR TEST IN PROGRESS 001 6 MIN 10 15AM colon does not blink CANCEL TEST TT Snes ea e COPA 2 Press within 15 seconds NOTE After pressing e PLEASE WAIT an error buzz sounds 1s displayed until the cartridge returns to original loading position If is not pressed within 15 seconds
59. f fetal hemoglobin does not react in the immunoassay or that the patient may be suffering from hemolytic anemia or polycythemia conditions which often result in a significant decrease in the life span of red blood cells Result preceded by a greater than sign gt A greater than sign in the display indicates a concentration above the upper limit of the test over range Report the result as being more than 14 0 Hemoglobin A c This method does not provide for re assay using a diluted sample To obtain a more quantitative test value at levels greater than 1446 use another test method All laboratory tests are subject to random error If the test result is questionable or if clinical signs and symptoms appear inconsistent with test results re assay the sample or confirm the result using another method Revised 6 03 4 11 p ITY NICO TOOWAH SNOLLONULSNI ONILVYAdO I OPERATING INSTRUCTIONS HEMOGLOBIN Aic OPERATING INSTRUCTIONS HEMOGLOBIN Ate Analyzing DCA 2000 Hemoglobin A1c Controls ONLY NOTE Follow instructions on page 4 8 if analyzing a control other than a DCA 2000 Hemoglobin Aj Control Controls are analyzed in the same manner as the patient sample A specially designed control bar code that enters the control lot number etc is provided with DCA 2000 HbA Controls DISPLAY READY SCAN BAR CODE 02 24 03 2 09PM RUN CONTROL C1 LOTC 1112 HbA1c 4 12 e Therefore when an
60. he capillary holder then repeat procedure using a new capillary holder 4 Position the capillary holder in the correct orientation for insertion into the reagent cartridge el 5 e gt UM E a 5 zZ gt Ll z zZ zZ Iss 5 Carefully insert the capillary holder into the reagent cartridge until the holder gently snaps into place IMPORTANT Avoid harsh insertion of the capillary holder It is important not to dislodge sample from the capillary tube or erroneous results may occur Revised 6 03 5 7 s gt OPERATING INSTRUCTIONS MICROALBUMIN CREATININE STEP 4 Analyzing the Patient Sample DISPLAY WHAT YOU DO READY SCAN BAR CODE 1 Locate the dot on the instrument next to the 02 24 03 2 09PM bar code track 2 Locate the bar code on the reagent cartridge 3 Hold the reagent cartridge so that the bar code faces right 4 Insert the reagent cartridge above dot into bar code track 5 Quickly within 1 sec and smoothly slide the reagent cartridge down past the dot A beep sounds to signal a successful scan f no beep sounds repeat procedure If a beep repeatedly fails to sound refer to Troubleshooting Section 6 5 8 Revised 6 03 DISPLAY LOAD CARTRIDGE INSERT PLUNGER PULL TAB Revised 6 03 PRESS L 1 CLOSE DOOR WHAT YOU DO 6 7 10 Open the reagent cartridge compartment door Hold the reagent cartridge so that
61. isplayed All factory settings defaults are now active Turn to Section 2 and follow the instruc tions beginning with Viewing Factory Settings You must now once again either accept or change factory settings SEE OPERATING MANUAL TEST ERROR 115 ERROR 101 TO 116 for HbA 1c ERROR 301 to 316 for Microalbumin Creatining An error relating to a test measurement parameter has been detected e g abnormal hemoglobin levels high C V s out of range hemoglobin transmission etc 1 Discard the test 2 See pages 6 6 6 7 6 8 and 6 9 3 Repeat the test using a new reagent cartridge and sample 4 If the problem persists record the test error identification number then refer to Section 8 for instructions on How to Report the Problem SEE OPERATING MANUAL ERROR 11 MOTOR OR ERROR 2x OPTICAL ERROR 3x TEMPERATURB ERROR 4x BAR CODE ERROR 9x INTERNAL The instrument has detected an instrument error motor or optical failure temperature etc e If testing is in progress press O Follow instructions under error message CANCELLED DISCARD TEST e If testing is not in progress turn the power OFF then ON If the problem persists record the error message Then refer to Section 9 for instructions on How to Report the Problem SEE OPERATING MANUAL LOT 2234 TEST UNKNOWN The instrument does not recognize the reagent test in use Contact Bayer Heal
62. layed AM or PM if AM PM T nsi format is selected 10 If 24 HR format is selected press O If AM PM format is selected press to advance cursor to the AM PM setting Press 4 or Y until the correct choice is displayed Press Press O Revised 6 03 3 11 This page left blank on purpose Intended for future use 3 12 Revised 6 03 l INSTRUMENT SETUP DISPLAY WAIT WARMING UP 02 24 03 2 09PM OR READY SCAN BAR CODE 02 24 03 2 09PM OR TEST IN PROGRESS 001 6 MIN 10 15AM INSTRUMENT SETUP 11400 yp ik F If computer port is Off OR 4 0 2 9801010 L C P BUVWXYZ If computer port is On Revised 6 03 WHAT YOU DO 1 Press Q3 2 Repeatedly press until INSTRUMENT SETUP is displayed Test in progress is not aborted 3 Press 9 4 Refer to the chart pages 2 8 and 2 9 to determine the definition of each number and abbreviated option appearing on your instrument s display Then continue with step 5 on page 3 14 MENU MENU INSTRUMENT SETUP DISPLAY OPTIONS SETTINGS continued DISPLAY 3 14 1 1 D 1 D 1 400 IL IP If computer port is Off OR 4 0 2 9801010 L C P BUVWXYZ If computer port is On 400 TIME FORMAT AM PM 4 vi i If computer port is Off OR 402 9801010 L C P BUVWXYZ If computer port is On 400 L CP If computer port is Off OR 4 0 2 9801010 L C P BUVWXYZ
63. les only The bar code for an out of date past expiration date reagent cartridge has been read Discard out of date reagent cartridge s PLEASE WAIT The cartridge compartment door was opened while testing was in progress Then the door was closed OR A System Error was detected and was pressed Wait until cartridge is in correct position for removal until CANCELLED DISCARD TEST is displayed SCAN CALIBRATION CARD LOT 1154 HbA1c Lot number and test name above are examples only The calibration card for the reagent cartridge in use has not been scanned Scan the correct calibration card Check name and lot number of cartridge in use SEE OPERATING MANUAL COMPUTER PORT ERROR E51 6 2 The computer port is ON and or e the instrument buffer is full of untransmitted results the computer will not accept results 1 Check to make sure cable is securely connected to both instrument and computer 2 If the problem persists refer to Section 9 for instructions on How to Report the Problem HINT To facilitate testing without transmitting results to a computer turn off the computer port refer to Section 3 MENU Revised 6 03 ERROR OR WARNING SEE OPERATING MANUAL ERROR 90 RAM MEMORY CAUSE When the power was turned ON D a failure was detected in the non volatile memory SOLUTION Press key INSTRUMENT SETUP PRESS C lt TO CONTINUE is d
64. llowing for 10 minutes Remove liquid blood as much as possible prior to disinfection a 0 5 sodium hypochlorite see household bleach below b 2 glutaraldehyde This is as referenced in the National Committee for Clinical Laboratory Standards Protection of Laboratory Workers from Instrument Biohazards and Infectious Disease Transmitted by Blood Body Fluids and Tissues Approved Guideline NCCLS Document M29 A ISBN 1 56238 339 6 2 After the exterior is clean and dry attach and plug in power cord Most household bleach is approx a 5 solution of sodium hypochlorite read the label Dilute household bleach containing approx 5 sodium hypochlorite as follows to obtain approx a 0 5 solution of sodium hypochlorite e 10 mL of household bleach 90 mL of water or alternatively part household bleach 9 parts water Revised 6 03 CHANGING THE AIR FILTER 1 Remove the filter holder from the right side of the instrument by rotating the holder counter clockwise until it stops and pulling it off 2 Dispose of the old air filter 3 Place a new air filter into the filter holder 4 Place the filter holder back on the instrument and rotate the holder clockwise until it stops Revised 6 03 7 3 AONVNALNIVIA ANILAOA ANV HAVO LNAWNALSNI INSTRUMENT CARE AND ROUTINE MAINTENANCE INSTRUMENT CARE AND ROUTINE MAINTENANCE CA
65. n the power is ON the card can be permanently damaged OPTIONAL While the instrument is warming up usually 1 2 minutes but can take up to 8 minutes you may access certain MENU items Refer to Section 3 for instructions Reminder Current time is denoted by blinking colon Time assay began is denoted by stationary colon 5 1 N SNOILONALSNI ONLLVAAJO N OPERATING INSTRUCTIONS OPERATING INSTRUCTIONS MICROALBUMIN CREATININE STEP 2 Calibration When To Calibrate Calibrate the System for each new lot number of reagent cartridges Materials Required Calibration Card provided in DCA 2000 Microalbumin Creatinine Reagent Kit NOTES The calibration card has two bar codes one on each side of the card Side 1 and Side 2 are identified on the card Either side may be scanned first After the first scan the display will indicate the next side to be scanned Side 1 1s Malb C Side 2 is Malb 2 DISPLAY READY SCAN BAR CODE 02 24 03 2 09PM OR Any result or menu display as long as testing is not in progress 52 It is necessary to scan both bar codes to calibrate the system for each new lot of reagent cartridges The instrument stores up to two calibrations for the DCA 2000 Microalbumin Creatinine Reagent Test The two calibrations must be for two different lot numbers The calibration stored in the instrument first is deleted when a calibration card for a third lot number is sca
66. nned WHAT YOU DO W Locate the dot on the instrument next to the bar code track Locate the bar code on the calibration card Hold the card so that the bar code faces right Insert the card into the bar code track above dot Hold card gently against the right side of track i i My a Uy y 4 S Cf d SS Revised 6 03 DISPLAY WHAT YOU DO 5 Quickly within 1 sec and smoothly slide the card down past the dot CALIBRATION DATA SAVED beep sounds to signal a successful scan LOT 0432 Malb C If no beep sounds repeat procedure If a beep repeatedly fails to sound refer to After 5 seconds the instrument then sounds a Troubleshooting Section 6 2 second beep and displays SCAN CALIBRATION CARD LOT 0432 Malb 2 CALIBRATION DATA SAVED i LOT 0432 Mall be 6 Repeat Steps 1 5 above using the other side of the card If the second bar code is not scanned within 5 minutes the display returns to the original display and the calibration process must start over See previous page el S E Z E Revised 6 03 5 3 2 E E e amp o OPERATING INSTRUCTIONS MICROALBUMIN CREATININE STEP 3 Preparing Patient Samples and Controls Materials Required e DCA 2000 Microalbumin Creatinine Reagent Kit e Patient Sample DCA 2000 Microalbumin Creatinine Control Kit or other control e Lint free tissue OPENING THE FOIL PACKAGE Containing Re
67. ol L then the Albumin Creatinine A C ratio is reported as mg mmol Remove cartridge a Open cartridge compartment door b Locate the button on the right side of the cartridge compartment Push and hold it down with your right hand c With your left hand gently push the tab on the cartridge to the right this action releases unlocks cartridge d Pull cartridge out of compartment e Discard cartridge in proper container according to your standard laboratory procedures If the door is opened within 15 minutes after assay completion the test result is displayed for only 30 seconds If the door is not opened the test result will remain displayed for 15 minutes At 15 minutes an audible tone error buzz sounds and the display changes to READY REMOVE TEST HINT If the displayed test result was not recorded use the MENU to recall up to 16 test results refer to SECTION 3 Revised 6 03 RESULTS Albumin The displayed test result requires no further calculation Albumin concentrations in the following range are reported 5 to 300 mg L The test is linear throughout this range Creatinine The displayed test result requires no further calculation Creatinine concentrations in the following range are reported 15 to 500 mg dL or 1 3 to 44 2 mmol L The test is linear throughout this range Albumin Creatinine Ratio The displayed test result requires no further calculation Albumin Creatinine ra
68. press moves cursor under setting for next option Press and 3 to cycle through choices for CONTROLS When the desired choice is displayed press moves cursor under setting for next option Press 4 and 3 to cycle through choices for COMPUTER PORT If you have selected 0 for COMPUTER PORT OFF e Check to make sure all numbers on Line 1 reflect your choices Reminder Options Chart is found on pages 2 8 2 9 Press 9 accepts all settings and advances display to SET DATE TIME Continue with instructions on page 2 14 Setting the Date and Time If you have selected 2 for COMPUTER PORT ON Continue with instructions on page 2 12 Changing Factory Settings For Computer Port ON Option 2 11 N dN LAS ANV G amp LNIVAOOV SNILL39 9NDIOVdNn NWO UNPACKING GETTING ACQUAINTED AND SET UP UNPACKING GETTING ACQUAINTED AND SET UP CHANGING FACTORY SETTINGS FOR COMPUTER PORT ON OPTION Refer to the chart on page 2 9 for Computer Port Configurations NOTE The first four numbers in each display below are factory settings The display on your instrument may be different for the first four numbers depending on whether the first four factory settings were accepted or changed DISPLAY 1140 2 9801110 COMPUTER PORT ON 1140 2 9801010 BAUD RATE 9600 1140 2 9801110 DATA BITS EIGHT 1140 2 9801010 PARITY NONE 2 12 WHAT YOU DO 1 Press places a cursor und
69. se a film to form on the internal optical surfaces affecting the optical transmission qualities of the instrument ROUTINE MAINTENANCE CHART Quarterly Exterior Bar Code Window NOTE Maintenance requirements for each laboratory must be assessed individually Use the above chart as a guide It is good laboratory practice to properly maintain your instrument Revised 6 03 Cartridge Compartment Change Air Filter Run Optical Test Cartridge As Required by spillage troubleshooting or contamination Exterior Change Air Filter Cartridge Compartment Bar Code Window Run Optical Test Cartridge 7 1 TIVO LNAWNALSNI AONVNALNIVIA ANLLAOA ANV INSTRUMENT CARE AND ROUTINE MAINTENANCE INSTRUMENT CARE AND ROUTINE MAINTENANCE EXTERIOR OF THE INSTRUMENT AND BAR CODE WINDOW WARNING Turn off the power and unplug the power cord before cleaning exterior of instrument VAROITUS Kytke virta pois ja irrota virtajohto ennen kuin alat puhdistaa laitteen ulkopintoja Do not allow water or other cleaning fluid to drip inside instrument bar code window area program card area and key pad are especially vulnerable 1 Clean the exterior of the instrument including the display panel and bar code window with a lint free cloth dampened with water A cloth dampened with ethanol may also be used If you desire to disinfect the exterior of the instrument expose the surface to either of the fo
70. sec and smoothly slide the card down past the dot A beep sounds to signal a successful scan f no beep sounds repeat procedure If a beep repeatedly fails to sound refer to Troubleshooting Section 6 CALIBRATION DATA SAVED LOT 0132 HbA1c After 5 seconds the display returns to the display in effect prior to calibration 4 2 Revised 6 03 STEP 3 Preparing Patient Samples and Controls Materials Required e DCA 2000 Hemoglobin Aj Reagent Kit e Patient Sample DCA 2000 Hemoglobin Aic Control Kit or other control e Lint free tissue e Clock or timer OPENING THE FOIL PACKAGE Containing Reagent Cartridge IMPORTANT Do not use scissors to cut open foil package Scissors can damage the reagent cartridge the flexible plastic pull tab on the cartridge or the sack containing desiccant 1 Remove one foil package containing a reagent cartridge from storage 2 Ti Refer to Recommended Procedures for Handling Reagent Cartridges in the DCA 2000 Hemoglobin Aic Reagent Kit package insert for instructions on how and when to open foil package Revised 6 03 INSPECTING THE CONTENTS OF THE FOIL PACKAGE The foil package contains 1 reagent cartridge with flexible pull tab and bar code label 2 small sack filled with desiccant When handling the reagent cartridge do not touch or otherwise contaminate the optical window or erroneous test results may occur Discard the reagent cartridge if
71. stralia Ltd ABN 22 000 138 714 Diagnostics Division 875 Pacific Hwy Pymble NSW 2073 AUSTRALIA 1 800 028 251 toll free Revised 6 03 Bayer House Strawberry Hill Newbury Berkshire RG14 1JA UK Ascensia Diabetes Support 0845 600 6030 UK 1 890 920 111 Republic of Ireland diabetes bayer co uk Bayer Inc Diagnostics Division Toronto Ontario MOW 1G6 Bayer plc MERA Middle East Eastern Europe Russia Africa Bayer House Strawberry Hill Newbury Berkshire RG14 1JA UK 444 1635 563000 Bayer South East Asia Pte Ltd No 9 Benoi Sector Singapore 629844 Tel 65 6261 3389 Fax 65 6266 3376 9 3 APPENDIX OPTICAL TEST CARTRIDGE RESULTS Initial Values Comparing New Values With Initial Values Date Compare the new values obtained with the initial values The Mean Transmittance should be within ur the range of 0 9500 to 1 0500 and should not have Standard Deviation varied by more than 0 0100 The Standard Drift Deviation should be less than 0 00150 and Drift should be less than 0 01400 Mean Transmittance DATE MEAN TRANSMITTANCE STANDARD DEVIATION DRIFT Revised 6 03 App 1 1 XIGNdddV INDEX A aborted 3 8 air 2 4 analysis 2 2 analyze 2 6 assay 2 3 authorized 1 1 bar code 2 2 beep 4 8 biohazard 4 5 blood 1 1 bubbles 4 7 buzz 4 10 C
72. subtle snap is heard felt HINT The cartridge is designed to fit only one way into the instrument 8 Close door Jd INSTRUMENT CARE AND ROUTINE MAINTENANCE DISPLAY WHAT YOU DO Upon completion of test 1 0001 T 0 00012 SD 9 Record the displayed results in the blanks 1 0 00387 DRIFT provided on the last page of this manual appendix 10 Remove cartridge a Open cartridge compartment door b Locate the button on the right side of the cartridge compartment Push and hold it down with your right hand c With your left hand gently push the plastic tab on the cartridge to the right this action releases unlocks cartridge d Pull cartridge out of compartment 11 Compare the results obtained with results obtained initially If the results are not within the limits found on page 7 6 and in the appendix refer to Section 9 for information on How to Report the Problem If the door is opened within 15 minutes after assay completion the test result is displayed for only 30 seconds If the door is not opened the test result will remain displayed for 15 minutes At 15 minutes an audible tone error buzz sounds and the display changes to READY REMOVE TEST 7 8 Revised 6 03 MINOR REPAIR You can 4 Remove the fuse holder from instrument replace the fuse If your instrument requires any other type of repair refer to Section 9 Service Information How to Replace the Fuse
73. sure you are using the correct side of the control card for the particular DCA 2000 Control level in use Cl Low C2 High 3 Hold the control card so that the bar code faces right 4 Insert the control card into the bar code track above dot Hold card gently against the right side of track 5 Quickly within 1 sec and smoothly slide the card down past the dot A beep sounds to signal a successful scan f no beep sounds repeat procedure If a beep repeatedly fails to sound refer to Troubleshooting Section 6 6 Press Revised 6 03 DISPLAY SCAN BAR CODE 02 24 03 C1 Malb C 11 10AM LOAD CARTRIDGE INSERT PLUNGER PRESS lt PULL TAB CLOSE DOOR Revised 6 03 WHAT YOU DO 10 11 12 13 14 15 Locate the bar code on the reagent cartridge Hold the cartridge so that the bar code faces right Insert the cartridge above dot into bar code track Quickly within 1 sec and smoothly slide the cartridge down past the dot A beep sounds to signal a successful scan f no beep sounds repeat procedure If a beep repeatedly fails to sound refer to Troubleshooting Section 6 Open the cartridge compartment door Hold the reagent cartridge so that the bar code faces right Insert the cartridge into the cartridge compartment until a subtle snap is heard felt HINT The cartridge is designed to fit only one way into the instrument Do not force c
74. t is OFF Configuration 2 ON Computer port is ON All subsequent results will be transferred to the computer NOTE The options below baud rate through modem control are selectable only if the computer port is turned ON B Baud Rate 9 9600 bps 4 4800 bps 2 2400 bps 1 1200 bps 3 300 bps U Data Bits 8 8 bits 7 7 bits V Parity 0 None 1 Odd 2 Even W Stop Bits 1 E 2 2 X Xon Xoff 0 Off Protocol 1 On Y Block 0 Off Transfer 1 On Z Modem 0 Off Control 1 On Revised 6 03 2 9 N dN LAS ANV GALNIVAOIV NILLI ONDIO VINO N UNPACKING GETTING ACQUAINTED AND SET UP UNPACKING GETTING ACQUAINTED AND SET UP ACCEPTING FACTORY SETTINGS If the factory setting for each option is acceptable press 9 If not see below If acceptable you are now ready to set the current date and time Refer to instructions on page 2 14 CHANGING FACTORY SETTINGS Before attempting to change factory settings read the following information on Keys and Cursor Keys moves the cursor underline under setting you desire to change O cycles through each setting choice such as AM PM or 24 HR for time format accepts all displayed settings for time date labels controls and computer port and immediately advances to SET DATE TIME display Important If you prematurely press before you are finished changing factory settings refer to
75. thCare Customer Service Department See Section 9 Service Information WRONG CARD displayed for 5 seconds then SCAN CALIBRATION CARD appears Revised 6 03 In response to SCAN CALIBRATION CARD the wrong calibration card is scanned Both sides of the calibration card must be scanned to enter the calibration for Microalbumin Creatinine Scan correct calibration card Check name and lot number of cartridge in use Repeat calibration process making certain to scan both sides of the calibration card 6 3 ON SNILOOHSATSNOUL Y S310 AOAAA SAD VSS3IW SNINSIVA ANV YOUN ON ERROR AND WARNING MESSAGES ERROR CODES amp TROUBLESHOOTING ERROR AND WARNING MESSAGES ERROR CODES AND TROUBLESHOOTING ERROR CODES ERROR CODE E1 CAUSE An internal system error has been detected SOLUTION Contact Bayer HealthCare Customer Service Department See Section 9 Service Information E2 When the power switch was set to ON D the instrument detected an error in the system s non volatile memory Set the power switch to OFF O Contact Bayer HealthCare Customer Service Department See Section 9 Service Information 6 4 E3 1 The wrong program card is plugged into the instrument 2 No program card is plugged into the instrument 3 The correct program card is correctly plugged into the instrument but the contacts on the program card need cleaning or are defecti
76. tios can be reported in the following range 1 to 2 000 mg g or 0 11 to 226 mg mmol Albumin or creatinine result preceded by a less than sign A less than sign in the display indicates a concentration below the lower limit of the test under range This method does not provide for re assay using a larger sample Albumin or creatinine result preceded by a greater than sign 2 A greater than sign in the display indicates a concentration above the upper limit of the test over range This method does not provide for re assay using a diluted sample To obtain a more quantitative test value use another test method Revised 6 03 Ratio result preceded by a less than sign or greater than gt sign or If the albumin and or creatinine result is under or over range the ratio will also be reported as under or over range In certain cases no ratio will be reported Example 1 If the albumin result is 2300 mg L and the creatinine result is 100 mg dL 8 84 mmol L then the ratio will be reported as 2300 mg g 226 5 mg mmol Example 2 If the albumin result is 75 mg L and the creatinine result is 15 mg dL 1 33 mmol L then the ratio will be reported as 2500 mg g 2556 4 mg mmol Example 3 If the albumin result is 2300 mg L and the creatinine result is 2500 mg dL 244 2 mmol L then no ratio will be reported Example 4 If the albumin result is lt 5 mg L and the creatinine result is lt 15 mg
77. two fuses one fuse is the replacement fuse Revised 6 03 AUDIBLE TONES Beep a short audible tone indicates successful completion of an activity such as scanning the bar code Buzz a long audible tone indicates an error condition or reminds you to perform an activity such as removing a reagent cartridge SCREEN SAVER When the instrument is not in use for more than 5 minutes the display will change to a block shaped moving cursor If the screen saver is on press any key to return to a normal display before performing any other steps BLINKING COLON IN DISPLAYED TIME The current time is displayed using a blinking colon When the colon does not blink the time displayed is the time the assay began WHEN TO TURN THE POWER OFF When the instrument is not in use the power may be turned OFF without loss of stored results However when the power is subsequently restored a warm up period of one to eight minutes is required IMPORTANT If power is turned OFF or interrupted while a test is in progress the test must be discarded Turn the power off when inserting or removing the program card and whenever instructed to do so by the particular procedure mainte nance etc in use 2 3 N dN LAS ANV G amp aLNIVAOOV DNILLAD OSNDIOVAND UNPACKING GETTING ACQUAINTED AND SET UP SET UP 4 Connect the power cord to the power cord connector on the instrument PLACING THE INSTRUMENT 5 Plug in power
78. ty Directive 73 23 EEC WARRANTY INFORMATION Contact your Authorized Bayer Representative for complete warranty information 1 1 NOILODnGOXLLNI SYMBOLS USED The following symbols are used throughout the product labeling for the DCA 2000 System Instrument Instrument Manual Quick Reference Guide DCA Reagent Labeling and Instructional inserts and the DCA Control packaging and instructional inserts Catalog number TE Fuse In vitro diagnostic device Quantity LOT Batch code REAGENT CARTRIDGE Reagent cartridge UM Consult operating instructions Menu Next T EXP Use by O Increase A Warning Attention consult Decrease instructions for use e mad aes Temperature limitations nd Escape S Do not use spray Normal control Abnormal control High control Low control Reconstitution fluid t l Manufactured by Authorized representative Calibration card Optical test cartridge Do not freeze A High temperature part U S PATENTS 6 043 043 5 822 071 5 610 073 5 385 847 5 372 948 5 305 093 5 272 093 5 258 311 5 220 161 5 162 237 5 151 369 5 084 397 4 990 075 4 970 171 4 968 472 4 898 824 4 847 209 4 727 036 4 658 022 4 647 654 4 629 692 D400 673 1 2 Revised 6 03 UNPACKING GETTING ACQUAINTED AND SET UP UNPACKING The DCA 2000 System arrives in one shipping carton Inspect the carton for shipping damage Unpack the carton Use extreme care when unpacking and handling
79. ults obtained 1 e Mean Transmittance Standard Deviation and Drift t is recommended that you record the results on the page provided in the appendix of this manual Comparing New Values With Initial Values Compare the new values obtained with the results recorded initially for your instrument see appendix The mean Transmittance should be within the range of 0 9500 to 1 0500 and should not have varied by more than 0 0100 The Standard Deviation should be less than 0 00150 and the Drift should be less than 0 01400 DISPLAY READY SCAN BAR CODE 02 24 03 2 09PM RUN STANDARD 1 7 6 WHAT YOU DO 1 Locate the bar code on the optical test cartridge 2 Hold the cartridge so that the bar code faces right 3 Insert the cartridge above dot on instrument into the bar code track 4 Quickly within 1 second and smoothly slide the cartridge down past the dot A beep sounds to signal a successful scan e If no beep sounds repeat the procedure If a beep repeatedly fails to sound refer to Troubleshooting Section 6 5 Press Revised 6 03 DISPLAY STANDARD 1 LOAD CLOSE DOOR PROCESSING STANDARD 1 6 MIN 10 02AM 6 MIN total test time After 1 minute 1 0001 T 0 00012 SD 1 5 MIN 10 03AM Revised 6 03 WHAT YOU DO 6 Open the cartridge compartment door 7 Hold the optical test cartridge so that the bar code faces right Insert the cartridge into the compartment until a
80. ve 1 Set the power switch to OFF O Remove the wrong program card Plug the correct program card completely into the instrument Set the power switch to ON D 2 Set the power switch to OFF O Plug the correct program card completely into the instrument Set the power switch to ON D 3 Set the power switch to OFF O Use a pencil eraser to gently clean the contacts on the program card Use a lint free tissue to wipe particles from the contacts Correctly insert the program card Set the power switch to ON D e If the problem persists contact Bayer HealthCare Customer Service Department See Section 9 Service Information Revised 6 03 ERROR CODE CAUSE SOLUTION 1 The wrong program card is plugged 1 Set the power switch to OFF O Plug E 4 into the instrument the correct program card completely into the instrument Set the power switch to ON D 2 The correct program card is not 2 Refer to step 1 completely plugged into the instrument 3 The contacts on the correct program 3 Set the power switch to OFF O card need to be cleaned or are Remove the program card defective Use a pencil eraser to gently clean the contacts on the program card Use a lint free tissue to wipe particles from contact Correctly insert the program card Set the power switch to ON I If the problem persists contact Bayer HealthCare Customer Service Department See Section 9 Service Information When
81. xt digit Repeat procedure to select second and third digits Press 9 SET SEAMEN OE BEES 5 To exit the MENU press O To display the next MENU item press E 34 Revised 6 03 ElRECALL CONTROL RESULTS e Up to 16 control results can be stored and Lower case c in display indicates a result for a recalled and also printed if a printer is in use control other than a DCA 2000 Control e Upper case C in display indicates a result fora A control lot number is displayed only for DCA DCA 2000 Control 2000 Controls Format for Recalled Results examples DCA 2000 CONTROLS ONLY Test Control Result Type Reagent Lot Number 7 J 9 85 HbAlc LOT 0325 02 24 03 C1 LOTC 0223 se nw Date of Assay Cl indicates DCA 2000 a result for the Control Lot Number DCA 2000 Normal or Low Control C is replaced with C2 for the DCA 2000 Abnormal or High Control and Clout or C2out for an out of range control ALL CONTROLS EXCEPT DCA 2000 CONTROLS Test Control Result Type Reagent Lot Number 9 8 HbAlc LOT 0325 02 24 03 c1 Date of Assay cl indicates control level 1 of 9 possible levels unless a DCA 2000 Control was run without scanning the DCA 2000 Control bar code card provided with the control kit continued on next page Revised 6 03 3 5 ANATA MENU Recall Control Results DISPLAY WHAT YOU DO WAIT WARMING UP 02 24 03 2 09PM 1 Press 69 2

Bayer DCA2000 - Frank`s Hospital Workshop

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