Bayer DCA 2000+ User manual

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Analyzer

Operating

Manual

50241739 ii Revised 6/03

Printed in U.S.A.

Unless otherwise noted, all

Trademarks are the property

of Bayer HealthCare LLC

SECTION 1. Introduction Page

System and Intended Use ......................................................................... 1.1

Features .......................................................................................... 1.1

Speciﬁcations..................................................................................... 1.1

Hazards........................................................................................... 1.1

Safety Standards...................................................................................1.1

Symbols Used .....................................................................................1.2

SECTION 2. Unpacking, Getting Acquainted and Set Up

Unpacking........................................................................................ 2.1

Carton Contents................................................................................... 2.1

Getting Acquainted

DCA 2000

 Analyzer (Front Panel) ........................................................... 2.2

DCA 2000

 Analyzer (Back Panel)............................................................2.3

Screen Saver....................................................................................2.3

Audible Tones.................................................................................. 2.3

Blinking Colon in Displayed Time.............................................................. 2.3

When To Turn the Power Off ................................................................... 2.3

Set Up

Placing the Instrument/Connecting the Power Cord/Inserting Program Card..................... 2.4

Checking to Verify Instrument Functions Properly .............................................. 2.5

Viewing Factory Settings ....................................................................... 2.6

Options ........................................................................................ 2.8

Accepting Factory Settings.................................................................... 2.10

Changing Factory Settings..................................................................... 2.10

Setting Date and Time......................................................................... 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 .............................................. 2.17

SECTION 3. Menu

Menu ............................................................................................. 3.1

RECALL PREVIOUS TESTS?................................................................. 3.2

SET SEQUENCE NUMBER?.................................................................. 3.4

RECALL CONTROL RESULTS? .............................................................. 3.5

VIEW CALIBRATION STATUS?.............................................................. 3.8

SET DATE/TIME?............................................................................ 3.10

INSTRUMENT SETUP?...................................................................... 3.13

SET CREATININE UNITS? .................................................................. 3.15

INSTRUMENT TEST? ....................................................................... 3.16

RUN CONTROL?............................................................................. 3.17

TABLE OF CONTENTS

Revised 6/03 iii

SECTION 4. Operating Instructions — Hemoglobin A

Page

Step 1: Turning the Power On ..................................................................... 4.1

Step 2: Calibration ................................................................................ 4.2

Step 3: Preparing Patient Samples and Controls.................................................... 4.3

Step 4: Analyzing the Patient Sample.............................................................. 4.8

Analyzing DCA 2000

Hemoglobin A1cControls, ONLY......................................... 4.12

Cancelling a Test ................................................................................ 4.15

SECTION 5. Operating Instructions — Microalbumin/Creatinine Page

Step 1: Turning the Power On ..................................................................... 5.1

Step 2: Calibration ................................................................................ 5.2

Step 3: Preparing Patient Samples and Controls.................................................... 5.4

Step 4: Analyzing the Patient Sample.............................................................. 5.8

Analyzing DCA 2000

Microalbumin/Creatinine Controls, ONLY................................ 5.12

Cancelling a Test ................................................................................ 5.15

SECTION 6. Error and Warning Messages, Error Codes and Troubleshooting

Chart of Contents................................................................................. 6.1

Error and Warning Messages ...................................................................... 6.2

Error Codes....................................................................................... 6.4

Troubleshooting ................................................................................. 6.10

SECTION 7. Instrument Care and Routine Maintenance

Instrument Care................................................................................... 7.1

Routine Maintenance Chart ....................................................................... 7.1

Exterior of Instrument and Bar Code Window (includes disinfection) .............................. 7.2

Changing Air Filter ............................................................................... 7.3

Cartridge Compartment ........................................................................... 7.4

Running Optical Test Cartridge.................................................................... 7.6

SECTION 8. Minor Repair

How to Replace the Fuse.......................................................................... 8.1

SECTION 9. Service Information

How to Report the Problem ....................................................................... 9.1

Accessory Items and Replacement Parts........................................................... 9.3

APPENDIX.................................................................................... App.1.1

iv Revised 6/03

INTR ODUCTION

Revised 6/03 1.1

The DCA 2000®System consists of:

•

DCA 2000® Analyzer

•

DCA 2000®Reagent Cartridges, Capillary Holders and Calibration Card

•

DCA 2000®Controls

•

Optical T est Cartridge

INTENDED USE

The DCA 2000® Analyzer quantitatively measures:

•

the percent concentration of Hemoglobin A

in blood

•

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

•

stores up to 16 test results

•

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 Temperature:

(15–32°C)—Hemoglobin A

(18–30°C)—Microalbumin/Creatinine

Relative Humidity Range:

10% – 90% RH (non-condensing)

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 StandardsAssociation (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 IVD Directive 98/79/EC (Oct./1998), which includes the EMC Directive 89/336 Amendment 92/31/EEC, and the Low Voltage Safety Directive 73/23/EEC.

WARRANTY INFORMATION

Contact your Authorized Bayer Representative for complete warranty information.

INTRODUCTION

1.2 Revised 6/03

Catalog number In vitro diagnostic device (LOT) Batch code Consult operating instructions (EXP) Use by Warning/Attention: consult

instructions for use

Temperature limitations

Do not use spray

Normal control

Abnormal control

High control

Low control

Reconstitution ﬂuid

High temperature part

Fuse

Quantity

Reagent cartridge Menu/Next Increase Decrease Enter Escape Manufactured by

Authorized representative

Calibration card

Optical test cartridge

Do not freeze

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).

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.

EC REP

UNPACKING, GETTING

ACQUAINTED AND SET UP

Revised 6/03 2.1

UNP ACKING

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 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.

CAR T ON 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® Analyzer

Cleaning Kit*

Optical T est Cartridge (in instrument cartridge compartment)

Program Card*

Power Line Cord*

Other (not shown)

• Operating Manual*

•Replacement Fuse (stored in fuse holder located inside the instrument)

• Air Filter Replacement Kit*

• HbA

Quick Reference Guide*

UNPACKING, GETTING ACQUAINTED AND SET UP

Missing Items?...Contact the nearest Bayer HealthCare ofﬁce or authorized distributor.

UNPACKING, GETTING

ACQUAINTED AND SET UP

2.2 Revised 6/03

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.

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 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).

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

Bar Code Track—area where reagent cartridge, calibration card or control card is placed prior to scanning bar code

➠

UNPACKING, GETTING

ACQUAINTED AND SET UP

Revised 6/03 2.3

BA CK PANEL

Power Switch—turns the power to the

instrument ON and OFF

Filter Holder—contains replaceable air ﬁlter that prevents dust contamination

Program Card Connector—accepts the program card

EIA-232-D Output—accepts the plug for the computer interface cable

Printer Output—accepts the plug for the printer cable

Power Cord Connector—accepts the plug for connecting the power cord to the instrument

Fuse Holder Compartment—holds two fuses (one fuse is the replacement fuse)

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 po wer 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 (maintenance, etc.) in use.

UNPACKING, GETTING

ACQUAINTED AND SET UP

2.4 Revised 6/03

UNPACKING, GETTING ACQUAINTED AND SET UP

SET UP

PLA CING THE INSTRUMENT/ CONNECTING THE POWER CORD/ INSERTING PROGRAM CARD

IMPORTANT: Do not place the instrument where it would be subjected to extreme temperature variations, direct sunlight, excessive humidity or air current, or excessive particulate matter.

1. Place the instrument on a ﬁrm, level* surface near a properly grounded electrical outlet.

0. *If 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).

0. IMPORTANT: The program card can be

damaged if inserted when the power is ON (I).

4. Connect the power cord to the power cord

connector on the instrument.

5. Plug in power cord to a properly grounded

outlet.

6. Move the instrument into place on the

designated work space.

•

Allow at least 2 inches of air space between the wall (or other surface) and the back and right sides of the instrument (ventilation panels).

UNPACKING, GETTING

ACQUAINTED AND SET UP

Revised 6/03 2.5

CHECKING TO VERIFY INSTRUMENT FUNCTIONS PROPERL Y

Set the power switch to ON (I).

•

After about 8 seconds, the software version is displayed.

(displayed for about 8 seconds)

•

Then:

The instrument is checking internal optics and proper operation of mechanical features.

•

Then:

Instrument does not function? Above display(s) fail(s) to appear?...Contact the nearest Bayer HealthCare ofﬁce or

authorized distributor. Otherwise, continue with “Viewing Factory Settings” (next).

INSTRUMENT SETUP

PRESS [<--] TO CONTINUE

INITIALIZING

KEEP DOOR CLOSED

BY BAYER CORPORATION

SOFTWARE VERSION

E3.11/01.04

UNPACKING, GETTING

ACQUAINTED AND SET UP

2.6 Revised 6/03

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”).

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 .

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.

Before deciding to accept factory settings, review the chart under OPTIONS, on the following pages.

FACTORY SETTING OPTION NUMBER DEFINITION T (Time) 1 AM/PM D (Date) 1 Month/Day/Year L (Labels 4 Time Assay Began;

displayed — (0) Sequence Number (reset with results) —(0) daily, automatically

—(0) at midnight)

C (Controls) 0 Use of DCA 2000

—(0) Controls, only

P (Port) 0 Computer Port is turned

—(0) Off (O)

1 1 4 0 00000000000000 TDLCP0000000000000

INSTRUMENT SETUP

PRESS [<--] TO CONTINUE

UNPACKING, GETTING ACQUAINTED AND SET UP

UNPACKING, GETTING

ACQUAINTED AND SET UP

Revised 6/03 2.7

(This page left blank on purpose.

Intended for future use)

UNPACKING, GETTING

ACQUAINTED AND SET UP

2.8 Revised 6/03

UNPACKING, GETTING ACQUAINTED AND SET UP

OPTIONS

All available settings are shown in the following chart.

•

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)

2Day

•

Month•Year

3Year–Month–Day

L (Labels displayed 0 No labels

with results)

1 Sequence number

(reset daily, automatically at midnight)

2 Sequence number

(continuous, 001 – 999)

3Time assay began

4* Time assay began; sequence number

(reset daily, automatically at midnight)*

5Time 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

•

If 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, is 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).

UNPACKING, GETTING

ACQUAINTED AND SET UP

Revised 6/03 2.9

OPTION SETTING NUMBER DEFINITION OF SETTING NUMBER P (Computer Port 0* OFF*—Computer port is OFF.

Conﬁguration)

2ON— 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*

77 bits

V (Parity) 0* None*

1 Odd 2Even

W (Stop Bits) 1* 1*

X (Xon—Xoff 0* Off*

Protocol)

1On

Y (Block 0 Off

Transfer)

1* On*

Z (Modem 0* Off*

Control) 1 On

UNPACKING, GETTING

ACQUAINTED AND SET UP

2.10 Revised 6/03

ACCEPTING FACT ORY SETTINGS

If the factory setting for each option is acceptable, press . 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

—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 Section 3, MENU for instructions on how to access “INSTRUMENT SETUP?”

HINT: Don’t press until all settings on Line 1 reﬂect your choices.

*Cursor

The cursor is the underline in the display. The cursor shows you which setting is ready for change.

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 until the cursor returns to the desired location.

1 1 4 0 0 nnnnnnnnnnnn TIME FORMAT AM/PM

DISPLA Y WHA T Y OU DO

1. Press (places a cursor under factory

setting for ﬁrst option, TIME FORMAT).

2. Press and to cycle through choices

for TIME FORMAT.

0. When the desired choice is displayed, press

0. (moves cursor under setting for next

0. option).

1 1 4 0 0 mmmmmmmmmmmm TIME FORMAT AM/PM

1 1 4 0 0 mmmmmmmmmmmm T D L C P mmmmmmmmmmmm

UNPACKING, GETTING ACQUAINTED AND SET UP

UNPACKING, GETTING

ACQUAINTED AND SET UP

Revised 6/03 2.11

DISPLA Y WHA T Y OU DO

3. Press and to cycle through choices for

DA TE FORMAT.

0. When the desired choice is displayed, press

0. (moves cursor under setting for next

0. option).

4. Press and to cycle through choices for

LABELS.

0. When the desired choice is displayed, press

0. (moves cursor under setting for next

0. option).

5. Press and to cycle through choices for

CONTROLS.

0. When the desired choice is displayed, press

0. (moves cursor under setting for next

0. option).

6. Press and to cycle through choices for

COMPUTER PORT.

0. If you have selected “0” for COMPUTER

PORT OFF:

•

Check to make sure all numbers on Line 1 reﬂect your choices.

• Reminder: Options Chart is found on pages

2.8–2.9.

•

Press (accepts all settings and

• advances display to SET DATE/TIME?)

•

Continue with instructions on page 2.14, “Setting the Date and Time.”

0. If you have selected “2” for

COMPUTER PORT ON:

•

Continue with instructions on page 2.12, “Changing Factory Settings For: Computer Port ‘ON’Option.”

1 1 4 0 0mm mmmmmmmmmm COMPUTER PORT OFFmmmmm

1 1 4 0 0 mmmmmmmmmmmm CONTROLS DCA 2000

1 1 4 0 0 mmmmmmmmmmmm LABELS USED TIME/DAILY

1 1 4 0 0 mmmmmmmmmmmm DATE FORMAT MM/DD/YY

UNPACKING, GETTING

ACQUAINTED AND SET UP

2.12 Revised 6/03

UNPACKING, GETTING ACQUAINTED AND SET UP

CHANGING FA CTOR Y 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).

DISPLA Y WHA T YOU DO

1. Press (places a cursor under factory

0. setting for ﬁrst computer port option).

2. Press and to cycle through choices for BAUD RATE.

0. When the desired choice is displayed, press

0. (moves cursor under setting for next

0. option).

3. Press and to cycle through choices for DATA BITS.

0. When the desired choice is displayed, press

0. (moves cursor under setting for next

0. option).

4. Press and to cycle through choices for PARITY.

0. When the desired choice is displayed, press

0. (moves cursor under setting for next

0. option).

1 1 4 0 2 9801010 PARITY NONE

1 1 4 0 2 9801110 DATA BITS EIGHT

1 1 4 0 2 9801010 BAUD RATE 9600

1 1 4 0 2 9801110 COMPUTER PORT ON

UNPACKING, GETTING

ACQUAINTED AND SET UP

Revised 6/03 2.13

DISPLA Y WHA T Y OU DO

5. Press and to cycle through choices for

STOP BITS.

0. When the desired choice is displayed, press

0. (moves cursor under setting for next

0. option).

6. Press and to cycle through choices for

XON/XOFF.

0. When the desired choice is displayed, press

0. (moves cursor under setting for next

0. option).

7. Press and to cycle through choices for

BLOCK TRANSFER.

0. When the desired choice is displayed, press

0. (moves cursor under setting for next

0. option).

8. Press and 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).

1 1 4 0 2 9801110 MODEM OFF

1 1 4 0 2 9821000 BLOCK XFER OFF

1 1 4 0 2 9821010 XON/XOFF OFF

1 1 4 0 2 9821010 STOP BITS ONE

UNPACKING, GETTING

ACQUAINTED AND SET UP

2.14 Revised 6/03

UNPACKING, GETTING ACQUAINTED AND SET UP

DISPLA Y WHA T Y OU DO

The display on your instrument is displaying the date and time in your chosen format.

1. Press or until the correct two digits are

displayed.

0. Press .

2. Press or until the correct two digits are

displayed.

0. Press .

3. Press or until the correct two digits are

displayed.

0. Press .

SET DATE/TIME

02/24/03 6:20AM

SET DATE/TIME

02/24/03 6:20AM

SET DATE/TIME

02/24/03 6:20AM

SETTING THE D ATE AND TIME

Use the following keys:

and 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)

To set the displayed date and time in the instrument

SET DATE/TIME

02/24/03 6:20AM

UNPACKING, GETTING

ACQUAINTED AND SET UP

Revised 6/03 2.15

DISPLAY

AM or PM if AM/PM

format is selected

AM or PM if AM/PM

format is selected

WHA T Y OU DO

4. Press or until the correct two digits are

displayed.

0. Press .

5. Press or until the correct two digits are

displayed.

•

If 24 HR format is selected, press .

•

If AM/PM format is selected, press .

• Then press or until the correct

choice is displayed.

• Press .

SET DATE/TIME

02/24/03 6:20AM

SET DATE/TIME

02/24/03 6:20AM

UNPACKING, GETTING

ACQUAINTED AND SET UP

2.16 Revised 6/03

UNPACKING, GETTING ACQUAINTED AND SET UP

SETTING CREATININE CONCENTRA TIONUNITS (Microalbumin/Creatinine Assay ONL Y)

The concentration units reported for creatinine are selectable between “mg/dL” and “mmol/L”. The factory setting is “mg/dL”.

DISPLA Y WHA T YOU DO

1. Press .

2. Repeatedly press , until

“SET CREATININE UNITS?” is displayed.

3. Press . This places a cursor below the “m” in

“mg/dL”, and the question mark disappears.

4. Press or to display “mmol/L” or

“mg/dL”.

5. Press to accept desired units.

6. Press to exit the MENU.

SET CREATININE UNITS?

mmol/L

SET CREATININE UNITS

mmol/L

SET CREATININE UNITS

mg/dL

SET CREATININE UNITS?

mg/dL

READY: SCAN BAR CODE

02/24/03 2:09PM

UNPACKING, GETTING

ACQUAINTED AND SET UP

Revised 6/03 2.17

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 provided by our Bayer HealthCare Customer Service Department Representative).

*It is recommended that you record the results on

the page provided in the appendix of this manual.

After the optical test cartridge is run initially,

it is recommended that the optical test cartridge be run:

•

quarterly

•

after cleaning the cartridge compartment

•

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.

RUNNING THE OPTICAL TEST CARTRIDGE (Standard 1) —Prior to Analyzing Samples f or the First Time

DISPLA Y WHA T Y OU 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.

0. A beep sounds to signal a successful scan.

•

If no beep sounds, repeat the procedure. If a beep repeatedly fails to sound, refer to Troubleshooting, Section 6.

5. Press .

RUN STANDARD 1?

READY: SCAN BAR CODE

02/24/03 2:09PM

UNPACKING, GETTING

ACQUAINTED AND SET UP

2.18 Revised 6/03

DISPLAY

6 MIN = total test time

After 1 minute:

Upon completion of test:

WHA T Y OU DO

6. Open the cartridge compartment door.

7. Hold the optical test cartridge so that the bar

code faces right.

0. Insert the cartridge into the compartment

until a subtle snap is heard/felt.

0. HINT: The cartridge is designed to ﬁt only

one way into the instrument.

8. Close door.

09. Record the displayed results in the blanks

provided on the last page of this manual (appendix).

10. Remove cartridge.

00. a) Open cartridge compartment door.*

00. b) Locate the button on the right side of the

cartridge compartment. Push and hold it down with your right hand.

00. c) With your left hand, gently push the plastic

tab on the cartridge to the right; this action releases (unlocks) cartridge.

00. 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.”

1.0001 T 0.00012 SDnnn S1 0.00387 DRIFT

1.0001 T 0.00012 SD S1 5 MIN 10:03AM

PROCESSING STANDARD

S1 6 MIN 10:02AM

STANDARD 1

LOAD, CLOSE DOOR

UNPACKING, GETTING ACQUAINTED AND SET UP

Revised 6/03 3.1

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”).

RECALL PREVIOUS TESTS?

SET SEQUENCE NUMBER? (optional)

RECALL CONTROL RESULTS?

VIEW CALIBRATION STATUS?

SET DATE/TIME?

INSTRUMENT SETUP?

SET CREATININE UNITS?

INSTRUMENT TEST?

RUN CONTROL? (optional)

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:

•

Press

Information and instructions for each MENU item are provided in this section.

3.2 Revised 6/03

RECALL PREVIOUS TESTS?

•

Up to 16 test results can be recalled (and printed if a printer is in use).

Recalled Test Result Format

Assay Result Reagent Lot No.

Date of Assay Sequence No. Time Assay Began

Date of Assay (optional) Time A. (optional)

6.0 % HbA1c LOT:0325 02/24/03 #011 11:24PM

DISPLAY

WHA T Y OU DO

1. Press .

(Test in progress is not aborted when MENU is pressed.)

TEST IN PROGRESS

#001 6 MIN 10:15AM

READY: SCAN BAR CODE

02/24/03 2:09PM

WAIT: WARMING UP

02/24/03 2:09PM

Date of Assay

Test

Type

Sequence No.

(optional)

Time Assay Began

Revised 6/03 3.3

DISPLAY

(example)

(after all results are displayed)

WHA T Y OU DO

2. Press .

•

The test result for the sample most recently assayed is displayed ﬁrst.

3. Press to recall up to 16 test results.

NOTES:

•

To print the displayed test result, press (if a printer is in use).

–If is pressed for more than 3 seconds, all stored

test results are printed.

•

To return display to “RECALL PREVIOUS TESTS?,” press once anytime during recall of test results.

•

To exit the MENU, press twice.

•

Albumin (A), creatinine (C), and the albumin/ creatinine ratio (A/C) results for the same specimen are shown sequentially on separate displays, and are labeled with the same sequence number (optional) and date/time.

This display is retained until:

•

a calibration card bar code is read

•

or is pressed

– 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.

NO MORE RESULTS STORED

IN INSTRUMENT

A/C=76 LOT:0325 02/24/03 #010 10:24PM

C=72.1mg/dL LOT:0325 09/13/02 #010 10:24PM

A=55.0mg/L LOT:0325 09/13/02 #010 10:24PM

6.0 % HbA1c LOT:0325 02/24/03 #011 11:24PM

RECALL PREVIOUS TESTS?

02/17/90 #001 11:47AM

3.4 Revised 6/03

SET SEQUENCE NUMBER? (optional)

DISPLAY

WHA T Y OU DO

1. Press .

2. Press .

NOTE: If a sequence number is selected while a test is in progress, the sequence number for the test in progress is changed to the newly selected sequence number.

3. Press .

4. Press or to select the digit above the

cursor.

0. Press to move cursor (right) to next

0. digit.

•

Repeat procedure to select second and third digits.

0. Press .

5. To exit the MENU, press .

0. To display the next MENU item, press .

SET SEQUENCE NUMBER?

SET SEQUENCE NUMBER

#009

SET SEQUENCE NUMBER?

TEST IN PROGRESS

#001 6 MIN 10:15AM

READY: SCAN BAR CODE

02/24/03 2:09PM

WAIT: WARMING UP

02/24/03 2:09PM

Revised 6/03 3.5

RECALL CONTROL RESULTS?

Format for Recalled Results (examples)

DCA 2000 CONTROLS, ONLY

Control Result Reagent Lot Number

mmmmmmmmmmmmmmmmmmmmmmmmm

**Cl—is replaced with “C2” for the DCA 2000 Abnormal or High Control and

“C1out” or “C2out” for an out-of-range control

ALL CONTROLS EXCEPT DCA 2000 CONTROLS*

Control Result Reagent Lot Number

*unless a DCA 2000 Control was run without scanning the DCA 2000

Control bar code card provided with the control kitmmmmmmmmn

9.8% HbA1c LOT:0325 02/24/03 c1 LOTC:0223

9.8% HbA1c LOT:0325 02/24/03 C1 LOTC:0223

• Up to 16 control results can be stored and recalled (and also printed if a printer is in use).

• Upper case “C” in display indicates a result for a DCA 2000

Control.

•Lower case “c” in display indicates a result for a control other than a DCA 2000 Control*.

•A control lot number is displayed only for DCA 2000 Controls.

Date of Assay C1— indicates

a result for the DCA 2000 Normal or Low Control**

DCA 2000 Control Lot Number

Date of Assay c1—indicates control

level “1” of 9 possible levels

Test

Type

Test

Type

—continued on next page

3.6 Revised 6/03

Recall Control Results

DISPLAY

WHA T Y OU DO

1. Press .

2. Repeatedly press , until “RECALL

CONTROL RESULTS?” is displayed.

(Test in progress is not aborted.)

3. Press .

•

The control result for the control most recently assayed is displayed ﬁrst.

RECALL CONTROL RESULTS?

TEST IN PROGRESS

#001 6 MIN 10:15AM

READY: SCAN BAR CODE

02/24/03 2:09PM

WAIT: WARMING UP

02/24/03 2:09PM

Revised 6/03 3.7

DISPLAY

(example)

Reminder: Upper case “C” indicates

result for a DCA 2000

Control

(after all control

results are displayed)

WHA T Y OU DO

4. Press to recall up to 16 control

0. results.

NOTES:

•

To print the control result, press (if a printer is in use).

– If is pressed for more than 3 seconds, all stored

control results are printed.

•

To return display to “RECALL CONTROL RESULTS,” press once anytime during recall of results.

•

To exit the MENU, press twice.

•

Albumin (A) and creatinine (C) for the same control are shown sequentially on separate displays, and are labeled with the same date.

This display is retained until:

• a bar code is scanned

•

or is pressed

– 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

CONTROL RESULTS?”

– If is pressed twice, you exit the MENU.

NO MORE CONTROLS STORED

IN INSTRUMENT

C=54.1mg/dL LOT:0105 02/24/03 C2 LOTC:0345

A=24.6mg/L LOT:0105 02/24/03 C2 LOTC:0345

9.8% HbA1c LOT:0325 02/24/03 C1 LOTC:0223

3.8 Revised 6/03

DISPLAY

WHA T Y OU DO

1. Press .

0. (A test in progress is not aborted.)

2. Repeatedly press , until

0. “VIEW CALIBRATION STATUS?” is

displayed.

3. Press .

•

The calibration status for the most recent calibration is displayed ﬁrst.

VIEW CALIBRATION STATUS?

TEST IN PROGRESS

#001 6 MIN 10:15AM

READY: SCAN BAR CODE

02/24/03 2:09PM

WAIT: WARMING UP

02/24/03 2:09PM

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.

Revised 6/03 3.9

DISPLAY

(example)

(after all stored

calibrations are displayed)

WHA T Y OU DO

4. Press to recall status of each

0. calibration stored.

NOTES:

•

To return display to “VIEW CALIBRATION STATUS?,” press once anytime during calibration status recall.

•

To exit the MENU, press twice.

This display is retained until:

•

a bar code is scanned

•

or is pressed

– If 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.

NO MORE CALIBRATIONS STORED IN INSTRUMENT

LOT:0222 Malb/C 02/24/03 11:30PM

LOT:0183 HbA1c 02/24/03 11:23PM

3.10 Revised 6/03

SET DATE/TIME?

Use the following keys:

and 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)

To set the displayed date and time in the instrument

SET DATE/TIME...

02/24/03 6:20AM

DISPLAY

WHA T Y OU DO

1. Press .

2. Repeatedly press until

0. “SET DATE/TIME?” is displayed.

3. Press .

SET DATE/TIME?

02/24/03 6:19AM

READY: SCAN BAR CODE

02/24/03 2:09PM

WAIT:WARMING UP

02/24/03 2:09PM

Revised 6/03 3.11

DISPLAY

AM or PM if AM/PM

format is selected

AM or PM if AM/PM

format is selected

WHA T Y OU DO

The display on your instrument is displaying the date and time in your chosen format.

4. Press or until the correct two digits are

displayed.

0. Press .

5. Press or until the correct two digits are

displayed.

0. Press .

6. Press or until the correct two digits are

displayed.

0. Press . The cursor will move back to the ﬁrst

digit of the date

7. Press to advance the cursor to the time

setting.

8. Press or until the correct two digits are

displayed.

0. Press .

9. Press or until the correct two digits are

displayed.

0. Press .

10.

•

If 24 HR format is selected, press .

10.

•

If AM/PM format is selected, press to advance cursor to the AM/PM setting.

0. Press or until the correct choice is

displayed.

0. Press .

SET DATE/TIME

02/24/03 6:20AM

SET DATE/TIME

02/24/03 6:20AM

SET DATE/TIME

02/24/03 6:20AM

SET DATE/TIME

02/24/03 6:20AM

SET DATE/TIME

02/24/03 6:20AM

3.12 Revised 6/03

(This page left blank on purpose.

Intended for future use.)

Revised 6/03 3.13

DISPLAY

If computer port is Off.

If computer port is On.

WHA T Y OU DO

1. Press .

2. Repeatedly press , until

0. “INSTRUMENT SETUP?” is displayed.

(Test in progress is not aborted.)

3. Press .

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.

0. Then continue with step 5 on page 3.14.

1 1 4 0 2 9801010mmmmm T D L C P BUVWXYZmmmmm

1 1 4 0 0 MMMMMMMMMMM T D L C P MMMMMMMMMMM

INSTRUMENT SETUP?

TEST IN PROGRESS

#001 6 MIN 10:15AM

READY: SCAN BAR CODE

02/24/03 2:09PM

WAIT: WARMING UP

02/24/03 2:09PM

INSTRUMENT SETUP?

3.14 Revised 6/03

DISPLAY

If computer port is Off.

If computer port is On.

If computer port is Off.

If computer port is On.

If computer port is Off.

If computer port is On.

WHA T Y OU DO

5. Press (places a cursor under the

0. setting for the ﬁrst option, TIME FORMAT).

6. Press and to cycle through choices for

TIME FORMAT.

0. When the desired choice is displayed, press

0. (moves cursor under setting for

0. next option).

Repeat step 6 to change settings for each option as desired.

1 1 4 0 2 9801010mmmmm T D L C P BUVWXYZmmmmm

1 1 4 0 0 mmmmmmmmmmmm T D L C P Mmmmmmmmmmmm

1 1 4 0 2 9801010mmmmm T D L C P BUVWXYZmmmmm

1 1 4 0 0 mmmmmmmmmmmm TIME FORMAT AM/PM

1 1 4 0 2 9801010mmmmm T D L C P BUVWXYZmmmmm

1 1 4 0 0 9801010mmmmm T D L C Pmmmmmmmmmmmmm

INSTRUMENT SETUP DISPLAY OPTIONS/SETTINGS continued

Revised 6/03 3.15

SET CREATININE UNITS

(Microalbumin/Creatinine Assay ONL Y)

The concentration units reported for creatinine are selectable between “mg/dL” and “mmol/L”. The factory setting is “mg/dL”.

DISPLA Y WHA T YOU DO

1. Press .

2. Repeatedly press , until

“SET CREATININE UNITS?” is displayed.

3. Press . This places a cursor below the “m”

in “mg/dL”, and the question mark disappears.

4. Press or to display “mmol/L” or

“mg/dL”.

5. Press to accept desired units.

6. Press to exit the MENU.

SET CREATININE UNITS?

mmol/L

SET CREATININE UNITS

mmol/L

SET CREATININE UNITS

mg/dL

SET CREATININE UNITS?

mg/dL

READY: SCAN BAR CODE

02/24/03 2:09PM

3.16 Revised 6/03

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.

Revised 6/03 3.17

DISPLA Y WHA T Y OU DO

1. Press .

2. Repeatedly press until

0. “RUN CONTROL?” is displayed.

3. Press .

4. Press or until the desired

control number (choices 1–9) is displayed.

0. Press .

5. Follow instructions in Section 4, page 4.3, or

Section 5, page 5.4, under “Preparing Patient Samples and Controls.”

SCAN BAR CODE

02/24/03 c1 11:10AM

SET CONTROL NUMBER

RUN CONTROL?

02/17/90 #001 11:47AM

READY: SCAN BAR CODE

02/24/03 2:09PM

RUN CONTROL? (optional)

•

Available only if selected via “INSTRUMENT SETUP” procedure

•

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)

Revised 6/03 4.1

OPERATING INSTRUCTIONS

HEMOGLOBIN A

OPERATING INSTRUCTIONS — HEMOGLOBIN A

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 P ower ON

DISPLAY

After about 8 seconds:

(displayed for 8 seconds)

(displayed for 3 seconds)

(a beep is heard)

WHA T Y OU DO

1. Set the power switch to ON.

0. 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 permanently damaged.

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.

0. Reminder: Current time is denoted by

“blinking colon.” Time assay began is denoted by stationary colon.

READY: SCAN BAR CODE

02/24/03 2:09PM

WAIT: WARMING UP

02/24/03 2:09PM

INITIALIZING

KEEP DOOR CLOSED

BY BAYER CORPORATION

SOFTWARE VERSION

E3.11/01.04

9.8% HbA1c LOT:0183 02/17/90 #001 11:47AM

4.2 Revised 6/03

OPERATING INSTRUCTIONS

HEMOGLOBIN A

OPERATING INSTRUCTIONS — HEMOGLOBIN A

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

Hemoglobin A1cReagent Kit)

DISPLAY

Any result or menu display

as long as testing is not in progress.

(After 5 seconds, the display

returns to the display in effect

prior to calibration.)

WHA T Y OU DO

1. Locate the dot (on the instrument) next to the bar code track.

2. Locate the bar code on the calibration card.

3. Hold the card so that the bar code faces right.

4. Insert the 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.

0. A beep sounds to signal a successful scan.

•

If no beep sounds, repeat procedure. If a beep repeatedly fails to sound, refer to Troubleshooting, Section 6.

CALIBRATION DATA SAVED LOT:0132 HbA1c

READY: SCAN BAR CODE

02/24/03 2:09PM

NOTES:

•

The instrument stores up to two calibrations for the DCA 2000 Hemoglobin A

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 scanned.

Revised 6/03 4.3

OPERATING INSTRUCTIONS

HEMOGLOBIN A

STEP 3: Preparing Patient Samples and Controls

Materials Required:

•

DCA 2000 Hemoglobin A1cReagent Kit

•

Patient Sample, DCA 2000®Hemoglobin A

Control Kit or other control

•

Lint-free tissue

•

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. Refer to “Recommended Procedures

for

Handling Reagent Cartridges” in the

DCA 2000

Hemoglobin A1cReagent Kit package insert for instructions on how and when to open foil package.

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)

OPTICAL WINDOW

4.4 Revised 6/03

OPERATING INSTRUCTIONS

HEMOGLOBIN A

OPERATING INSTRUCTIONS — HEMOGLOBIN A

CAPILLARY HOLDER

Unused capillary holders may be saved and used with any lot of Hemoglobin A

reagent cartridges.

1. Open plastic wrap by tearing wrap at serrated

1. edge.

2. Inspect the capillary holder for the presence of:

0. absorbent pad

0. glass capillary

0. latching mechanism

If the capillary holder is missing any of the above parts, discard the capillary holder (refer to Service Information, Section 9).

Revised 6/03 4.5

OPERATING INSTRUCTIONS

HEMOGLOBIN A

FILLING THE CAPILLARY WITH WHOLE BLOOD

(Instructions for ﬁlling capillary with control sample are found in the

DCA 2000 Hemoglobin A

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

•

For DCA 2000 Control — Steps 1 through 14 under “WHAT

YOU DO” on pages 4.12-4.13

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.

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 1-56238339-6] 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.

VAROITUS! MAHDOLLINEN TARTUNTAVAARA

Terveydenhoitohenkilökunnan, joka käyttää tätä laitetta useiden ihmisten tutkimiseen, tulee ottaa huomioon, että kaikki tuotteet, jotka joutuvat kosketukseen ihmisveren kanssa, ovat myös puhdistuksen jälkeen mahdollisia viirustartuntalähteitä.

Tartuntojen välttämiseksi suosittelemme laboratorion omien turvallisuusohjeiden ehdotonta noudattamista.

4.6 Revised 6/03

OPERATING INSTRUCTIONS

HEMOGLOBIN A

OPERATING INSTRUCTIONS — HEMOGLOBIN A

FILLING THE CAPILLARY WITH WHOLE BLOOD—continued

1. Complete step A) OR step B) depending upon the blood sample source. Continue with step 2 on the next page.

0. IMPORTANT: Do not allow blood to contact

the plastic part of the capillary holder. Any blood touching the plastic will be transferred 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 capillary holder, discard capillary holder.

0. A) If ﬁlling glass capillary with blood from

ﬁnger prick:

0. A) 1. Hold the capillary holder at an angle.

0. A) 2. Touch only the tip of the capillary to a

small drop of blood on the ﬁnger until the capillary is ﬁlled.

A) 0.

0. B) If ﬁlling glass capillary with blood

obtained by venipuncture:

0. B) 1. Mix sample well (by inversion or use of

an aliquot mixer) to prevent separation of red blood cells and plasma.

0. B) 2. Remove stopper from blood collection

tube in such a way that a small sample of blood remains on stopper.

0. B) 3. Hold the capillary holder at an angle.

0. B) 4. Touch only the tip of the capillary to

blood sample on stopper.

0. B) 0.

•

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.

B) 0.

Revised 6/03 4.7

OPERATING INSTRUCTIONS

HEMOGLOBIN A

2. Using a lint-free tissue, carefully wipe the

outside of the glass capillary.

0. 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.

0. IMPORTANT: Avoid harsh insertion of

capillary holder. It is important not to dislodge sample from glass capillary or erroneous results may occur.

4.8 Revised 6/03

OPERATING INSTRUCTIONS

HEMOGLOBIN A

OPERATING INSTRUCTIONS — HEMOGLOBIN A

DISPLA Y WHA T Y OU DO

1. Locate the dot (on the instrument) next to the

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.

0. A beep sounds to signal a successful scan.

•

If no beep sounds, repeat procedure. If a beep repeatedly fails to sound, refer to Troubleshooting, Section 5.

READY: SCAN BAR CODE

02/24/03 2:09PM

STEP 4:Analyzing the Patient Sample

Revised 6/03 4.9

OPERATING INSTRUCTIONS

HEMOGLOBIN A

DISPLA Y WHA T YOU DO

6. Open the cartridge compartment door.

7. Hold the reagent cartridge so that the bar code

faces right.

0. Insert the reagent cartridge into the cartridge

compartment until a subtle snap is heard/felt.

High temperature part Huom. Kuumenee käytettäessä

HINT: The cartridge is designed to ﬁt only one

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).

LOAD CARTRIDGE

PULL TAB, CLOSE DOOR

4.10 Revised 6/03

OPERATING INSTRUCTIONS

HEMOGLOBIN A

OPERATING INSTRUCTIONS — HEMOGLOBIN A

DISPLAY

(colon does not blink)

After test is completed:

(colon does not blink)

WHA T Y OU DO

10. Record the displayed result before removing

the reagent cartridge.

11. Remove the reagent cartridge.

00. a) Open cartridge compartment door.*

00. b) Locate the button on the right side of the

cartridge compartment. Push and hold it down with your right hand.

00. c) With your left hand, gently push the tab on

the cartridge to the right; this action releases (unlocks) cartridge.

00. d) Pull the reagent cartridge out of the

compartment.

00. 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.

00. If the door is not opened, the test result will remain

displayed for 15 minutes.

00. At 15 minutes, an audible tone (error buzz) sounds

and the display changes to “READY: REMOVE TEST.”

00. HINT: If the displayed test result was not recorded,

use the MENU to recall up to 16 test results (refer to SECTION 3).

%HbA1c mmm #001 10:21

TEST IN PROGRESS

#001 6 MIN 10:15AM

Revised 6/03 4.11

OPERATING INSTRUCTIONS

HEMOGLOBIN A

RESULTS:

The displayed test result requires no further calculation. Hemoglobin A

concentrations in the

following range are reported:

2.5% to 14.0%mm

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

. This method does not provide for re-assay using a larger sample aliquot. Results less than 2.5% Hemoglobin A

are rare and may indicate that the sample contains substantial amounts of 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 (>):

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

. This method does not provide for re-assay using a diluted sample. To obtain a more quantitative test value at levels greater than 14%, 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.

4.12 Revised 6/03

OPERATING INSTRUCTIONS

HEMOGLOBIN A

OPERATING INSTRUCTIONS — HEMOGLOBIN A

Analyzing DCA 2000

Hemoglobin A1cControls, ONLY

NOTE: Follow instructions on page 4.8, if

analyzing a control other than a DCA 2000 Hemoglobin A

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

•

Therefore, when analyzing DCA 2000 Hemoglobin A

Controls, use instructions that contain steps for scanning the control bar code card found on pages 4.12–4.14.

•

If using controls other than DCA 2000 Hemoglobin A

Controls, refer to Section 3, page 3.17, for information on labeling and storing the control result.

WHA T Y OU 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.

C1 = = 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.

0. A beep sounds to signal a successful scan.

•

If no beep sounds, repeat procedure. If a beep repeatedly fails to sound, refer to Troubleshooting, Section 6.

6. Press .

RUN CONTROL C1?

LOTC:1112 HbA1c

READY: SCAN BAR CODE

02/24/03 2:09PM

Revised 6/03 4.13

OPERATING INSTRUCTIONS

HEMOGLOBIN A

DISPLA Y WHA T Y OU DO

07. Locate the bar code on the reagent cartridge.

08. Hold the reagent cartridge so that the bar code

faces right.

09. Insert the reagent cartridge (above dot) into

bar code track.

10. Quickly (within 1 sec.) and smoothly, slide

the reagent cartridge down past the dot.

00. A beep sounds to signal a successful scan.

00.

•

If no beep sounds, repeat procedure. If a beep repeatedly fails to sound, refer to Troubleshooting, Section 6.

11. Open the cartridge compartment door.

12. Hold the reagent cartridge so that the bar code

faces right.

00. Insert the reagent cartridge into the cartridge

compartment until a subtle snap is heard/felt.

00. HINT: The reagent cartridge is designed to ﬁt

only one way into the instrument. Do not force cartridge into instrument.

13. Using a smooth, slow continuous motion,

pull ﬂexible pull-tab completely out of reagent cartridge.

14.

Close door. Dispose of ﬂexible pull-tab.

00. 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).

LOAD CONTROL

PULL TAB, CLOSE DOOR

SCAN BAR CODE: HbA1c 02/24/03 C1 11:10AM

4.14 Revised 6/03

OPERATING INSTRUCTIONS

HEMOGLOBIN A

OPERATING INSTRUCTIONS — HEMOGLOBIN A

DISPLAY

(colon does not blink)

Then:mmmmmmmmnmmmmmm.

After test is completed:

For a result within the acceptable control range printed in the control package insert

For a result outside the acceptable control range printed in the control package insert

WHA T Y OU DO

15. NOTE: If “CONTROL OUT OF RANGE” is

displayed, press to display value of out-ofrange control.

15. Record the displayed result before removing

the reagent cartridge.

16. Remove the reagent cartridge.

00. a) Open cartridge compartment door.*

00. b) Locate the button on the right side of the

cartridge compartment. Push and hold it down with your right hand.

00. c) With your left hand, gently push the tab on

the cartridge to the right; this action releases (unlocks) cartridge.

00. d) Pull the reagent cartridge out of the

compartment.

00. e) Discard cartridge in proper container,

according to your standard laboratory procedures.

00.

*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.”

15.

CONTROL OUT OF RANGE

PRESS [ESC] TO PROCEED

%HbA1cmmmmm

0 C1 10:21AM

PROCESSING CONTROL

C1-HbA1c 6 MIN 11:11AM

Revised 6/03 4.15

OPERATING INSTRUCTIONS

HEMOGLOBIN A

CANCELLING A TEST

You may cancel a test anytime. Important: If a test in progress is cancelled, the

test must be discarded.

DISPLAY

(colon does not blink)

(an error buzz sounds)

WHA T Y OU DO

1. Press .

2. Press within 15 seconds.

NOTE: After pressing , “PLEASE WAIT” is displayed until the cartridge returns to original loading position.

0. If is not pressed within 15 seconds:

•

the display returns to the original display (i.e., either display shown in Step 1).

•

the test in progress continues without interruption

CANCEL TEST?

PRESS [<--] TO CONFIRM

TEST IN PROGRESS

#001 6 MIN 10:15AM

LOAD CARTRIDGE

PULL TAB, CLOSE DOOR

4.16 Revised 6/03

OPERATING INSTRUCTIONS

HEMOGLOBIN A

OPERATING INSTRUCTIONS — HEMOGLOBIN A

DISPLAY

–

displayed if the test is cancelled after the bar code is scanned but before the cartridge compartment door is opened

–a beep is heard

–displayed if the test is cancelled during

sample analysis (cartridge is in instrument)

–an error buzz is heard

WHA T Y OU DO

3. The test is cancelled.

•

Scan bar code

ORmm

•

Open cartridge compartment door and remove cartridge.

CANCELLED: DISCARD TEST

02/24/03 10:18AM

READY: SCAN BAR CODE

02/24/03 2:09PM

Revised 6/03 5.1

OPERATING INSTRUCTIONS

MICROALBUMIN/CREATININE

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 P ower ON

DISPLAY

After about 8 seconds:

(displayed for 8 seconds)

(displayed for 3 seconds)

(a beep is heard)

WHA T Y OU DO

1. Turn the power switch to ON.

0. 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 permanently damaged.

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.

0. Reminder: Current time is denoted by

“blinking colon.” Time assay began is denoted by stationary colon.

READY: SCAN BAR CODE

02/24/03 2:09PM

WAIT: WARMING UP

02/24/03 2:09PM

INITIALIZING

KEEP DOOR CLOSED

BY BAYER CORPORATION

SOFTWARE VERSION

E3.11/01.04

9.8% HbA1c LOT:0183 02/17/90 #001 11:47AM

5.2 Revised 6/03

OPERATING INSTRUCTIONS

MICROALBUMIN/CREATININE

OPERATING INSTRUCTIONS — MICRO ALB UMIN / 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 is Malb/C; Side 2 is Malb-2.

•

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 scanned.

DISPLAY

Any result or menu display

as long as testing is not in progress.

WHA T Y OU DO

1. Locate the dot (on the instrument) next to the bar code track.

2. Locate the bar code on the calibration card.

3. Hold the card so that the bar code faces right.

4. Insert the card into the bar code track (above dot). Hold card gently against the right side of track.

READY: SCAN BAR CODE

02/24/03 2:09PM

Revised 6/03 5.3

OPERATING INSTRUCTIONS

MICROALBUMIN/CREATININE

DISPLAY

After 5 seconds, the instrument then sounds a

2 second beep and displays:

WHA T Y OU DO

5. Quickly (within 1 sec.) and smoothly, slide the card down past the dot.

0. A beep sounds to signal a successful scan.

•

If no beep sounds, repeat procedure. If a beep repeatedly fails to sound, refer to Troubleshooting, Section 6.

6. Repeat Steps 1–5 above using the other side of the card.

0. 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.)0.

CALIBRATION DATA SAVED LOT:0432 Malb-2

SCAN CALIBRATION CARD LOT:0432 Malb-2

CALIBRATION DATA SAVED LOT:0432 Malb/C

5.4 Revised 6/03

OPERATING INSTRUCTIONS

MICROALBUMIN/CREATININE

OPERATING INSTRUCTIONS — MICRO ALB UMIN / CREATININE

STEP 3: Preparing Patient Samples and Controls

Materials Required:

•

DCA 2000 Microalbumin/Creatinine Reagent Kit

•

Patient Sample, DCA 2000®Microalbumin/ Creatinine Control Kit or other control

•

Lint-free tissue

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 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.

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)

OPTICAL WINDOW

Revised 6/03 5.5

OPERATING INSTRUCTIONS

MICROALBUMIN/CREATININE

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:

0. absorbent pad

0. glass capillary

0. latching mechanism

0. starch plug

3. If the capillary holder is missing any of the above parts, discard the capillary holder; also discard if the starch plug is at the bottom of the capillary tube (refer to Service Information, Section 9).

plunger

5.6 Revised 6/03

OPERATING INSTRUCTIONS

MICROALBUMIN/CREATININE

OPERATING INSTRUCTIONS — MICRO ALB UMIN / CREATININE

FILLING THE CAPILLARY WITH URINE

1. Complete step A) OR step B) depending upon

the volume of urine specimen available. Continue with Step 2 on the next page.

1. 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:

A) 1. Immerse the tip of the capillary tube in

the urine specimen to a level just above the plug in the capillary.

A) 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.

A) 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.

(Instructions for ﬁlling capillary with control sample are found in the DCA 2000 Microalbumin/Creatinine Control package insert.)

B) If ﬁlling capillary tube with urine from a

container with a small sample volume:

B) 1. 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.

B) 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.

B) 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 5.7

OPERATING INSTRUCTIONS

MICROALBUMIN/CREATININE

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 the 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 the capillary holder. It is important not to dislodge sample from the capillary tube, or erroneous results may occur.

5.8 Revised 6/03

OPERATING INSTRUCTIONS

MICROALBUMIN/CREATININE

OPERATING INSTRUCTIONS — MICRO ALB UMIN / CREATININE

DISPLA Y WHA T Y OU DO

1. Locate the dot (on the instrument) next to the

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.

0. A beep sounds to signal a successful scan.

•

If no beep sounds, repeat procedure. If a beep repeatedly fails to sound, refer to Troubleshooting, Section 6.

READY: SCAN BAR CODE

02/24/03 2:09PM

STEP 4:Analyzing the Patient Sample

Revised 6/03 5.9

OPERATING INSTRUCTIONS

MICROALBUMIN/CREATININE

DISPLA Y WHA T YOU DO

6. Open the reagent cartridge compartment door.

7. Hold the reagent cartridge so that the bar code

faces right.

0. Insert the reagent cartridge into the cartridge

compartment until a subtle snap is heard/felt.

0. HINT: The cartridge is designed to ﬁt only

one way into the instrument. Do not force cartridge into instrument.

8. Insert plunger into hole in top of capillary

holder.

0. Depress plunger into capillary holder fully.

Plunger will lock into the capillary holder.

0. Press .

High temperature part Huom. Kuumenee käytettäessä

00.

9. Using a smooth, slow, continuous motion,

pull ﬂexible pull-tab completely out of reagent cartridge.

10. 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 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

PULL TAB, CLOSE DOOR

LOAD CARTRIDGE, INSERT

PLUNGER, PRESS [<--]

5.10 Revised 6/03

OPERATING INSTRUCTIONS

MICROALBUMIN/CREATININE

OPERATING INSTRUCTIONS — MICRO ALB UMIN / CREATININE

DISPLAY

(colon does not blink)

After test is completed:

(colon does not blink)

WHA T Y OU DO

11. Record the displayed result before removing

cartridge.

11. NOTE: If creatinine units are mg/dL, then the

Albumin/Creatinine (A/C) ratio is reported as mg/g. If the creatinine units are mmol/L, then the Albumin/Creatinine (A/C) ratio is reported as mg/mmol.

12. Remove cartridge.

00. a) Open cartridge compartment door.*

00. b) Locate the button on the right side of the

cartridge compartment. Push and hold it down with your right hand.

00. c) With your left hand, gently push the tab on

the cartridge to the right; this action releases (unlocks) cartridge.

00. d) Pull cartridge out of compartment.

00. e) Discard cartridge in proper container,

according to your standard laboratory procedures.

00. *If the door is opened (within 15 minutes

after assay completion), the test result is displayed for only 30 seconds.

00. If the door is not opened, the test result will

remain displayed for 15 minutes.

00. At 15 minutes, an audible tone (error buzz)

sounds and the display changes to “READY: REMOVE TEST.”

00. HINT: If the displayed test result was not

recorded, use the MENU to recall up to 16 test results (refer to SECTION 3).

A=102mg/L C=141mg/dL A/C=72 #001 10:17AM

TEST IN PROGRESS

#001 6 MIN 10:15AM

Revised 6/03 5.11

OPERATING INSTRUCTIONS

MICROALBUMIN/CREATININE

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 ratios 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 (>): 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.

Ratio result preceded by a less than (<) sign or greater than (>) 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 >300 mg/L and the creatinine result is 100 mg/dL (8.84 mmol/L), then the ratio will be reported as >300 mg/g (>26.5 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 >500 mg/g (>56.4 mg/mmol).

Example 3: If the albumin result is >300 mg/L and the creatinine result is >500 mg/dL (>44.2 mmol/L), then no ratio will be reported (---).

Example 4: If the albumin result is <5 mg/L and the creatinine result is <15 mg/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.

5.12 Revised 6/03

OPERATING INSTRUCTIONS

MICROALBUMIN/CREATININE

OPERATING INSTRUCTIONS — MICRO ALB UMIN / CREATININE

Analyzing DCA 2000

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

•

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.

WHA T Y OU 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 sure you are using the correct side of the control card for the particular DCA 2000 Control level in use.

C1 = = 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.

0. A beep sounds to signal a successful scan.

•

If no beep sounds, repeat procedure. If a beep repeatedly fails to sound, refer to Troubleshooting, Section 6.

6. Press .

RUN CONTROL C1?

LOTC:1112 Malb/C

READY: SCAN BAR CODE

02/24/03 2:09PM

Microalb umin / Creatinine

Revised 6/03 5.13

OPERATING INSTRUCTIONS

MICROALBUMIN/CREATININE

DISPLA Y WHA T Y OU DO

07. Locate the bar code on the reagent cartridge.

08. Hold the cartridge so that the bar code faces

right.

09. Insert the cartridge (above dot) into bar code

track.

10. Quickly (within 1 sec.) and smoothly, slide the cartridge down past the dot.

00. A beep sounds to signal a successful scan.

00.

•

If no beep sounds, repeat procedure. If a beep repeatedly fails to sound, refer to Troubleshooting, Section 6.

11. Open the cartridge compartment door.

12. Hold the reagent cartridge so that the bar code faces right.

00. Insert the cartridge into the cartridge

compartment until a subtle snap is heard/felt.

00. HINT: The cartridge is designed to ﬁt only

one way into the instrument. Do not force cartridge into instrument.

13. Insert plunger into hole in top of capillary holder.

00. Depress plunger into capillary holder fully.

Plunger will lock into the capillary holder.

00. Press .

14. Using smooth, slow continuous motion, pull ﬂexible pull-tab completely out of reagent cartridge.

15.

Close door. Dispose of ﬂexible pull-tab.

00. 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).

PULL TAB, CLOSE DOOR

LOAD CARTRIDGE, INSERT

PLUNGER, PRESS [<--]

SCAN BAR CODE Malb/C 02/24/03 C1 11:10AM

— continued on next page

5.14 Revised 6/03

OPERATING INSTRUCTIONS

MICROALBUMIN/CREATININE

OPERATING INSTRUCTIONS — MICRO ALB UMIN / CREATININE

DISPLAY

(colon does not blink)

After test is completed:

For a result within the acceptable control range printed in the control package insert

NOTE: The albumin/creatinine ratio is not

calculated for controls.

For a result outside the acceptable control range printed in the control package insert

WHA T Y OU DO

16. NOTE: If “CONTROL OUT OF RANGE” is displayed, press to display value of out-ofrange control.

15. Record the displayed result before removing

cartridge.

17. Remove cartridge.

00. a) Open cartridge compartment door.*

00. b) Locate the button on the right side of the

cartridge compartment. Push and hold it down with your right hand.

00. c) With your left hand, gently push the

ﬂexible tab on the cartridge to the right; this action releases (unlocks) cartridge.

00. d) Pull cartridge out of compartment.

00. e) Discard cartridge in proper container,

according to your standard laboratory procedures.

00.

*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.”

CONTROL OUT OF RANGE

PRESS [ESC] TO PROCEED

A=102mg/L C=141 mg/dL

0 C1 11:11AM

PROCESSING CONTROL

C1-Malb/C 7 MIN 11:11AM

Revised 6/03 5.15

OPERATING INSTRUCTIONS

MICROALBUMIN/CREATININE

CANCELLING A TEST

You may cancel a test anytime. Important: If a test in progress is cancelled, the

test must be discarded.

DISPLAY

(colon does not blink)

(an error buzz sounds)

WHA T Y OU DO

1. Press .

2. Press within 15 seconds.

NOTE: After pressing , “PLEASE WAIT” is displayed until the cartridge returns to original loading position.

0. If is not pressed within 15 seconds:

•

the display returns to original display (i.e., either display shown in Step 1).

•

the test in progress continues without interruption

CANCEL TEST?

PRESS [<--] TO CONFIRM

TEST IN PROGRESS

#001 6 MIN 10:15AM

PULL TAB, CLOSE DOOR

LOAD CARTRIDGE, INSERT

PLUNGER, PRESS [<--]

— continued on next page

5.16 Revised 6/03

OPERATING INSTRUCTIONS

MICROALBUMIN/CREATININE

OPERATING INSTRUCTIONS — MICRO ALB UMIN / CREATININE

DISPLAY

–

displayed if the test is cancelled after the bar code is scanned but before the cartridge compartment door is opened

–a beep is heard

–displayed if the test is cancelled during

sample analysis (cartridge is in instrument)

–an error buzz is heard

WHA T Y OU DO

3. The test is cancelled.

•

Scan bar code

ORmm

•

Open cartridge compartment door and remove cartridge.

CANCELLED: DISCARD TEST

02/24/03 10:18AM

READY: SCAN BAR CODE

02/24/03 2:09PM

Revised 6/03 6.1

ERROR AND WARNING MESSAGES,

ERROR CODES & TROUBLESHOOTING

ERROR AND WARNING MESSAGES, ERR OR CODES AND TROUBLESHOOTING

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 .................................................................. 6.2

OUT OF DATE CONTROL.......................................................... 6.2

OUT OF DATE REAGENT.......................................................... 6.2

PLEASE WAIT ............................................................................. 6.2

SCAN CALIBRATION CARD..................................................... 6.2

SEE OPERATING MANUAL (COMPUTER

PORT ERROR-51)........................................................................ 6.2

SEE OPERATING MANUAL ERROR 90—RAM MEMORY .. 6.3

SEE OPERATING MANUAL/TEST ERROR XXX................... 6.3

SEE OPERATING MANUAL (ERROR Xx)............................... 6.3

SEE OPERATING MANUAL

(TEST UNKNOWN)

................... 6.3

WRONG CARD............................................................................ 6.3

ERROR CODES

E-1 ................................................................................................. 6.4

E-2.................................................................................................. 6.4

E-3.................................................................................................. 6.4

E-4.................................................................................................. 6.5

E-5................................................................................................. 6.5

E-6.................................................................................................. 6.5

TROUBLESHOOTING

..................................................................................................... 6.10

Hemoglobin A

ERROR 101 ........................ 6.6

ERROR 102 ........................ 6.6

ERROR 103 ........................ 6.6

ERROR 104 ........................ 6.6

ERROR 105 ........................ 6.6

ERROR 106 ........................ 6.6

ERROR 107 ........................ 6.6

ERROR 108 ........................ 6.7

ERROR 109 ........................ 6.7

ERROR 110 ........................ 6.7

ERROR 111 ........................ 6.7

ERROR 112 ........................ 6.7

ERROR 113 ........................ 6.7

ERROR 114 ........................ 6.7

ERROR 115 ........................ 6.7

ERROR 116 ........................ 6.7

Microalbumin / Creatinine

ERROR 301 ........................ 6.8

ERROR 302 ........................ 6.8

ERROR 303 ........................ 6.8

ERROR 304 ........................ 6.8

ERROR 305 ........................ 6.8

ERROR 306 ........................ 6.8

ERROR 307 ........................ 6.8

ERROR 308 ........................ 6.8

ERROR 309 ........................ 6.9

ERROR 310 ........................ 6.9

ERROR 311 ........................ 6.9

ERROR 313 ........................ 6.9

ERROR 315 ........................ 6.9

ERROR 316 ........................ 6.9

6.2 Revised 6/03

ERROR AND WARNING MESSAGES,

ERROR CODES & TROUBLESHOOTING

ERROR AND WARNING MESSAGES, ERR OR CODES AND TROUBLESHOO TING

ERROR AND WARNING MESSAGES

ERROR OR WARNING CAUSE SOLUTION

The cartridge compartment door was Open the cartridge compartment door. opened while testing was in progress. Remove and discard the reagent The door was then closed and “PLEASE cartridge. WAIT” was displayed prior to

Repeat the test.

“CANCELLED: DISCARD TEST.”

• If the error message “SEE OPERATING

•

MANUAL/(any system error)” is

was pressed in response to

• displayed again, refer to Section 9, for

“SEE OPERATING MANUAL/

• instructions on “How to Report the

(any system error) ” • Problem.”

The cartridge compartment door was Close door. opened while testing was in progress.

Wait for next display “PLEASE WAIT.”

The bar code for an out-of-date control Discard out-of-date control(s). (past expiration date) has been read.

(displayed for 15 seconds)

Control lot number and test

name above are examples, only.

The bar code for an out-of-date (past Discard out-of-date reagent cartridge(s). expiration date) reagent cartridge has been read.

(displayed for 15 seconds)

Reagent lot number and test

name above are examples, only.

The cartridge compartment door was Wait until cartridge is in correct position for opened while testing was in progress. removal (until “CANCELLED: DISCARD Then the door was closed. TEST” is displayed).

A System Error was detected and

was pressed.

The calibration card for the reagent Scan the correct calibration card. cartridge in use has not been scanned.

•

Check name and lot number of cartridge

• in use.

Lot number and test name

above are examples, only

The computer port is ON and/or: 1. Check to make sure cable is securely

•

the instrument buffer is full of

0. connected to both instrument and

•

untransmitted results

0. computer.

•

the computer will not accept results

2. If the problem persists, refer to Section 9,

0. for instructions on “How to Report the

0. Problem.”

0. HINT: To facilitate testing (without

0. transmitting results to a computer) turn

0. off the computer port (refer to Section 3,

0. MENU).

SEE OPERATING MANUAL

COMPUTER PORT ERROR-E51

SCAN CALIBRATION CARD

LOT:1154 HbA1c

PLEASE WAIT

02/17/90 #001 11:47AM

OUT OF DATE REAGENT

LOT:1154 HbA1c

OUT OF DATE CONTROL

LOTC:1154 HbA1c

DOOR OPEN ERROR

CLOSE DOOR

CANCELLED: DISCARD TEST 02/24/03 10:18AM

Revised 6/03 6.3

ERROR AND WARNING MESSAGES,

ERROR CODES & TROUBLESHOOTING

ERROR OR WARNING CAUSE SOLUTION

When the power was turned ON (I), a Press key. failure was detected in the non-volatile

“INSTRUMENT SETUP/PRESS

memory.

[<--]

TO CONTINUE” is displayed.

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.

An error relating to a test measurement 1.Discard the test. parameter has been detected (e.g.,

2.See pages 6.6, 6.7, 6.8, and 6.9.

abnormal hemoglobin levels, high C.V.’s,

3.Repeat the test using a new reagent

out of range hemoglobin transmission, etc.).

0.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.”

* The instrument has detected an instrument

•

If testing is in progress, press .

error (motor or optical failure, temperature,

• Follow instructions under error message

etc.).

• “CANCELLED: DISCARD TEST.”

*OR:

•

If testing is not in progress, turn the

ERROR 2x—OPTICAL

• power OFF, then ON.

ERROR 3x—TEMPERATURE

If the problem persists, record the error

ERROR 4x—BAR CODE

message. Then refer to Section 9, for

ERROR 9x—INTERNAL

instructions on “How to Report the Problem.”

The instrument does not recognize the Contact Bayer HealthCare Customer Service reagent test in use. Department. See Section 9, Service

Information.

In response to “SCAN CALIBRATION Scan correct calibration card. CARD,” the wrong calibration card is

• Check name and lot number of cartridge

scanned.

•

in use.

(displayed for 5 seconds—then “SCAN Both sides of the calibration card must

• Repeat calibration process making certain

CALIBRATION CARD” appears) be scanned to enter the calibration for

• to scan both sides of the calibration card.

Microalbumin / Creatinine. •

WRONG CARD

SEE OPERATING MANUAL

LOT:2234 TEST: UNKNOWN

SEE OPERATING MANUAL

ERROR 11-MOTOR

SEE OPERATING MANUAL

TEST ERROR 115

SEE OPERATING MANUAL

ERROR 90-RAM MEMORY

ERROR—101 TO 116 for HbA

1c ERROR—301 to 316 for Microalbumin/Creatining

6.4 Revised 6/03

ERROR AND WARNING MESSAGES,

ERROR CODES & TROUBLESHOOTING

ERROR AND WARNING MESSAGES, ERR OR CODES AND TROUBLESHOO TING

ERROR CODES

ERROR CODE CAUSE SOLUTION

An internal system error has been Contact Bayer HealthCare Customer detected. Service Department. See Section 9, Service

Information.

When the power switch was set to ON (I), Set the power switch to OFF (O). the instrument detected an error in the

Contact Bayer HealthCare Customer

system’s non-volatile memory.

Service Department. See Section 9, Service Information.

1. The wrong program card is 1. Set the power switch to OFF (O).

0. plugged into the instrument.

0. Remove the wrong program card.

0. Plug the correct program card completely

0. into the instrument.

0. Set the power switch to ON (I).

2. No program card is plugged into 2. Set the power switch to OFF (O).

0. the instrument.

0. Plug the correct program card completely

0. into the instrument.

0. Set the power switch to ON (I).

3. The correct program card is correctly 3. Set the power switch to OFF (O).

0. plugged into the instrument but the

0. Use a pencil eraser to gently clean the

0. contacts on the program card need

0. contacts on the program card.

0. cleaning or are defective.

0. Use a lint-free tissue to wipe particles

0. from the contacts.

0. Correctly insert the program card.

0. Set the power switch to ON (I).

•

If the problem persists, contact

• Bayer HealthCare Customer Service

•

Department. See Section 9, Service

0.•Information.

Revised 6/03 6.5

ERROR AND WARNING MESSAGES,

ERROR CODES & TROUBLESHOOTING

ERROR CODE CAUSE SOLUTION

1. The wrong program card is plugged 1. Set the power switch to OFF (O). Plug

0. into the instrument. 0. the correct program card completely into

0. the instrument. Set the power switch to

0. ON (I).

2. The correct program card is not 2. Refer to step 1.

0. completely plugged into the

0. instrument.

3. The contacts on the correct program 3. Set the power switch to OFF (O).

0. card need to be cleaned or are 0. Remove the program card.

0. defective.

0. Use a pencil eraser to gently clean the

0. contacts on the program card.

0. Use a lint-free tissue to wipe particles

0. from contact.

0. Correctly insert the program card.

0. Set the power switch to ON (I).

0. If the problem persists, contact Bayer

0. HealthCare Customer Service

0. Department. See Section 9, Service

0. Information.

When the power switch was set to ON (I), 1. Set the power switch to OFF (O). the instrument detected use of a defective

2. Remove the program card.

program card.

3. Plug a replacement program card into the

instrument. (Refer to Section 9, SERVICE

0. INFORMATION, for instructions on

0. where to order replacement program card.)

4. Set the power switch to ON (I).

0. If the problem persists, contact Bayer

0. HealthCare Customer Service

0. Department. See Section 9, Service

0. Information.

When the power switch was set to ON (I), Set the power switch to OFF (O). the instrument detected an error in

Contact Bayer HealthCare Customer

system timing.

Service Department. See Section 9, Service Information.

6.6 Revised 6/03

ERROR AND WARNING MESSAGES,

ERROR CODES & TROUBLESHOOTING

ERROR AND WARNING MESSAGES, ERR OR CODES AND TROUBLESHOO TING

ERROR CODE CAUSE SOLUTION

101

Buffer Reading Out of Limits — High

102

Buffer Reading Out of Limits — Low

103

High Variation in Readings for Buffer

104

106

Reading for Hemoglobin Value — Low

105

107

Reading for Hemoglobin Value — High

No cartridge present. Optical alignment problem.

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.

Condensation on cartridge — cartridge not allowed to warm up

Rare. Particulate contamination.

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 > 24 g/dL — patient has abnormally high hemoglobin

— very high triglycerides

Repeat test with cartridge in place. If problem persists, contact Bayer

HealthCare Customer Service Department. See Section 9, Service Information.

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.

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.

Ensure that capillary is completely ﬁlled with no air bubbles.

Wait 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 6.7

ERROR AND WARNING MESSAGES,

ERROR CODES & TROUBLESHOOTING

ERROR CODE CAUSE SOLUTION

108

High Variation in Readings for Hemoglobin

109

110

111

112

Readings for Glycated Hemoglobin Out of Limits

113

114

116

Irregular Reaction Kinetics for Glycated Hemoglobin

115

Final Hemoglobin Reading Greater Than Reading at Earlier Checkpoint

Rare. Particulate contamination.

Cartridge exposed to excessive temperature and/or humidity.

Particulate contamination.

Blood left too long in capillary.

If problem persists, contact Bayer HealthCare Customer Service Department. See Section 9, Service Information.

Ensure proper storage of reagent kits. Open foil package just prior to use

of cartridge.

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.

Wait no more than 5 minutes after ﬁlling capillary before starting test.

6.8 Revised 6/03

ERROR AND WARNING MESSAGES,

ERROR CODES & TROUBLESHOOTING

ERROR AND WARNING MESSAGES, ERR OR CODES AND TROUBLESHOO TING

ERROR CODE CAUSE SOLUTION

301

Buffer Mean Out of Limits — Low Absorbance

302

Buffer Mean Out of Limits — High Absorbance

303

High Variation in Readings for Buffer

304

Sample Blank Mean Out of Limits — Low

305

Sample Blank Mean Out of Limits — High

306

High Variation in Readings for Sample Blank

307

308

Readings for Albumin Out of Limits

No cartridge present. Optical alignment problem.

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.

Rare. Particulate contamination.

Particulate contamination.

Urine sample is turbid or highly pigmented.

Rare. Particulate contamination.

Rare. Cartridge exposed to excessive

temperature and/or humidity.

Repeat test with cartridge in place. If problem persists, contact Bayer

HealthCare Customer Service Department. See Section 9, Service Information.

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.

Repeat test. If problem persists, contact Bayer HealthCare

Customer Service Department. See Section 9, Service Information.

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.

Repeat test. If problem persists, contact Bayer HealthCare

Customer Service Department. See Section 9, Service Information.

Ensure proper storage of reagent kits. Open foil package just prior to use

of cartridge.

Revised 6/03 6.9

ERROR AND WARNING MESSAGES,

ERROR CODES & TROUBLESHOOTING

ERROR CODE CAUSE SOLUTION

309

High Variation in Albumin Readings

310

311

Readings for Creatinine Out of Limits

313

Irregular Reaction Kinetics for Creatinine

315

Normalization Factor has not been set

316

Normalization Factor outside allowable range

Rare. Particulate contamination.

Rare. Cartridge exposed to excessive

temperature and/or humidity.

Cartridge exposed to excessive temperature and/or humidity.

Particulate contamination.

Instrument has not been adjusted to run the Microalbumin/Creatinine assay.

Normalization Cartridge is not located properly in instrument.

Normalization Cartridge is dirty or defective.

Repeat test. If problem persists, contact Bayer

HealthCare Customer Service Department. See Section 9, Service Information.

Ensure proper storage of reagent kits. Open foil package just prior to use

of cartridge.

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.

Contact Bayer HealthCare Customer Service Department. See Section 9, Service Information.

Ensure that cartridge is inserted completely into instrument.

If problem persists, contact Bayer HealthCare Customer Service Department. See Section 9, Service Information.

6.10 Revised 6/03

ERROR AND WARNING MESSAGES,

ERROR CODES & TROUBLESHOOTING

ERROR AND WARNING MESSAGES, ERR OR CODES AND TROUBLESHOO TING

TROUBLESHOOTING

PROBLEM SOLUTION

Beep repeatedly fails to sound after scanning a bar code. 1. Insert the cartridge or expanded bottom of card (whichever

0. applies) into the bar code track below the dot.

2. Quickly (within 1 second) and smoothly, slide the card or

0. cartridge up past the dot.

0. If a beep continually fails to sound, refer to Section 8 for

0. 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 Discard the reagent cartridge. reagent cartridge.

•

Refer to Section 9 for instructions on “How to Report the

•

Problem.”

Revised 6/03 7.1

INSTRUMENT CARE

AND ROUTINE MAINTENANCE

INSTR UMENT CARE AND R OUTINE MAINTEN ANCE

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 T emperature:

•

(15–32°C)—Hemoglobin A

(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 cause a ﬁlm to form on the internal optical surfaces affecting the optical transmission qualities of the instrument.

ROUTINE MAINTENANCE CHART

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.

As Required (by spillage, troubleshooting or

Weekly Quarterly contamination)

Exterior Cartridge Compartment Exterior Bar Code Windo w Change Air Filter Change Air Filter

Run Optical Test Cartridge Cartridge Compartment

Bar Code Window Run Optical Test Cartridge

7.2 Revised 6/03

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.

0. If you desire to disinfect the exterior of the

instrument, expose the surface to either of the following for 10 minutes.

Remove liquid blood

(as much as possible) prior to disinfection.

0. a. 0.5% sodium hypochlorite (see household

bleach, below)

0. b. 2% glutaraldehyde

0.a.

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.

•

10 mL of household bleach + 90 mL of water or alternatively:

•

1 part household bleach + 9 parts water

Revised 6/03 7.3

INSTRUMENT CARE

AND ROUTINE MAINTENANCE

CHANGING THE AIR FIL TER

1. Remove the ﬁlter holder from the right side of the instrument by rotating the holder counterclockwise (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).

Filter

Holder

Filter

Holder

Air

Filter

7.4 Revised 6/03

INSTRUMENT CARE

AND ROUTINE MAINTENANCE

INSTRUMENT CARE AND ROUTINE MAINTENANCE

CAR TRIDGE COMPARTMENT

WARNING: Turn off the power and unplug the power cord before cleaning

the cartridge compartment.

VAROITUS: Kytke virta pois ja irrota virtajohto, ennen kuin puhdistat

kasettipesän.

Do not allow liquid to drip into instrument. If liquid drips into instrument, optics can be destroyed.

1. Open the cartridge compartment door as far as possible.

2. Using a lint-free cloth dampened with water or ethanol, wipe the inside surface of the 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.

4. Insert the tip of a straightened paper clip

(or other like device) into the top hole on the spring.

0. •

Gently, pull metal end toward center of cartridge compartment to release one side of the spring from the cartridge holder.

0. •

Repeat procedure to release other side of spring from cartridge holder.

5. Pull cartridge return spring completely out of

instrument.

6. Clean cartridge return spring using any of the

following:

•

warm solution of mild detergent and water (you may immerse cartridge return spring)

•

lint-free cloth dampened in water or ethanol

0. IMPORTANT: Make sure the leaf springs are

not bent or damaged while cleaning. Damaged leaf springs will not function properly.

7. Dry cartridge return spring with a clean,

lint-free cloth. Set spring aside.

TOP HOLE

BOTTOM HOLE

CARTRIDGE RETURN SPRING

LEAF SPRINGS

Revised 6/03 7.5

INSTRUMENT CARE

AND ROUTINE MAINTENANCE

08. Using a clean, dry, sponge swab (provided in

“Cleaning Kit,” Part No. 95001901) remove spilled liquid from the cartridge holder.

00. IMPORTANT: Do not use a cotton swab.

Cotton ﬁbers may be left on surface and interfere with instrument optical system.

0.0 With compartment door partially closed,

rotate the cartridge holder as shown to locate and remove any additional liquid.

00.

NOTE: Cartridge holder cannot be rotated if compartment door is completely open.

09. Dampen (do not soak) a sponge swab with

water or ethanol. Clean cartridge holder (rotating cartridge holder as necessary).

00. IMPORTANT: Do not allow liquid to drip

off

sponge swab into instrument. If liquid

drips

into instrument, optics can be

destroyed.

10. 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).

11. Locate the leaf spring on one side of the cartridge return spring.

12. With the leaf spring orientated toward the back of the instrument, lower the leaf spring into the instrument as follows:

00. a. Hold onto both sides of the cartridge

return spring (near the holes).

00. 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 the compartment. Release (let go of) spring.

00. b. 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.

00. b. IMPORTANT: Never force the spring into

the cartridge compartment! Forcing the spring into the compartment will damage the spring.

00. c. Gently and carefully, push down on edge

of cartridge return spring (with hole) and insert edge into slot.

00. c. Repeat “step c” to attach opposite side

of cartridge return spring to cartridge compartment.

00. c. 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.

00. c. IMPORTANT: Failure to properly

replace return spring can result in erroneous test results.

13. Run optical test cartridge according to instructions that follow.

00. (Allows you to verify that the optical system

was not damaged or contaminated by dust, etc., during this maintenance procedure.)

➠

7.6 Revised 6/03

INSTRUMENT CARE

AND ROUTINE MAINTENANCE

INSTRUMENT CARE AND ROUTINE MAINTENANCE

RUNNING THE OPTICAL TEST CAR TRIDGE (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 results obtained (i.e., Mean Transmittance, Standard Deviation and Drift).*

*It 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.

DISPLA Y WHA T Y OU 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.

0. A beep sounds to signal a successful scan.

•

If no beep sounds, repeat the procedure. If a beep repeatedly fails to sound, refer to Troubleshooting, Section 6.

5. Press .

RUN STANDARD 1?

READY: SCAN BAR CODE

02/24/03 2:09PM

Revised 6/03 7.7

INSTRUMENT CARE

AND ROUTINE MAINTENANCE

DISPLAY

6 MIN = total test time

After 1 minute:

WHA T Y OU DO

6. Open the cartridge compartment door.

7. Hold the optical test cartridge so that the bar

code faces right.

0. Insert the cartridge into the compartment until a

subtle snap is heard/felt.

0. HINT: The cartridge is designed to ﬁt only one

way into the instrument.

8. Close door.

1.0001 T 0.00012 SD0 S1 5 MIN 10:03AM

PROCESSING STANDARD

S1 6 MIN 10:02AM

STANDARD 1

LOAD, CLOSE DOOR

7.8 Revised 6/03

INSTRUMENT CARE

AND ROUTINE MAINTENANCE

INSTRUMENT CARE AND ROUTINE MAINTENANCE

DISPLAY

Upon completion of test:

WHA T Y OU DO

09. Record the displayed results in the blanks

provided on the last page of this manual (appendix).

10. Remove cartridge.

00. a) Open cartridge compartment door.*

00. b) Locate the button on the right side of the

cartridge compartment. Push and hold it down with your right hand.

00. c) With your left hand, gently push the plastic

tab on the cartridge to the right; this action releases (unlocks) cartridge.

00. d) Pull cartridge out of compartment.

11. Compare the results obtained with results obtained initially.

00. 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.”

00.

*If the door is opened (within 15 minutes after assay

completion), the test result is displayed for only 30 seconds.

00.

If the door is not opened, the test result will remain displayed for 15 minutes.

00. At 15 minutes, an audible tone (error buzz) sounds and

the display changes to “READY: REMOVE TEST.”

1.0001 T 0.00012 SDmm S1 0.00387 DRIFT

Revised 6/03 8.1

MINOR REPAIR

You can:

•

replace the fuse

If your instrument requires any other type of repair, refer to Section 9, Service Information.

How to Replace the Fuse

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.

WARNING: Set the power switch to OFF. Unplug power cord from wall

outlet. Unplug power cord from instrument.

VAROITUS: Kytke virta pois (off

-asento). Irrota virtajohto

seinäpistokkesta. Irrota virtajohto laitteesta.

2. Locate the groove on the side of the fuse holder

that faces power cord connector.

3. Insert the tip of a screwdriver into the groove.

Then, exert pressure to unsnap fuse holder from instrument.

4. Remove the fuse holder from instrument.

replacement fuse blown fuse fuse block

5. Remove and dispose of blown fuse.

6. Push the replacement fuse out of the black box

using the tip of a screwdriver or similar device.

7. Insert replacement fuse onto fuse block.

WARNING: For continued protection against ﬁre hazard, replace only with

the indicated type and rating of fuse.

0. VAROITUS: Paloturvallisuussyistä,

käytä vain suositeltuja sulakkeita.

8. Re-insert fuse holder into instrument (snap

gently into place.)

Groove

Revised 6/03 9.1

SERVICE INFORMATION

When you ha v e 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 requested 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

0. shooting been reviewed?

2. Have you performed the

YES NO

0. required maintenance

0. procedures (Section 7)?

3. Set the power switch to OFF.

YES NO

0. Make sure the program card

0. is securely plugged in. Set

0. the power switch to ON. Are

0. the following displayed?

(if instrument is not within

operating temperature range)

4. If displays do not appear:

•

is the instrument plugged YES NO

• into a live,AC electrical

• outlet?

•

Is the line fuse defective? YES NO

• Refer to Section 7, Minor

• Repair.

5. Do any characters on the dis-

YES NO

0. play appear partially defective?

READY: SCAN BAR CODE

02/24/03 2:09PM

xWAIT: WARMING UP

02/24/03 2:09PM

INITIALIZING

KEEP DOOR CLOSED

BY BAYER CORPORATION

SOFTWARE VERSION

E3.11/01.04

9.2 Revised 6/03

SERVICE INFORMATION

If your instrument is connected

YES NO

0. to a printer or computer,

are all cables securely attached?

7. List error messages that have appeared. ______

0. ______________________________________

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.

Revised 6/03 9.3

SERVICE INFORMATION

ACCESSORY ITEMS

Part Number Description Hemoglobin A

5035C DCA 2000®Reagent Kit 5068A DCA 2000

Normal &

Abnormal Control Kit

Microalbumin/Creatinine

6011A DCA 2000

Reagent Kit

6012A DCA 2000

Low & High

Control Kit

NOTE: Part numbers are subject to change without notice.

TO ORDER:

Contact the nearest Bayer HealthCare ofﬁce or authorized distributor.

Distributed by:

Bayer HealthCare LLC Elkhart, IN 46515 USA

REPLA CEMENT PAR TS

Part Number Description

SR002810 Program Card for Instrument

English 40330028 N.A. Power Cord for Instrument 40330046 Euro Power Cord for Instrument 40330050 U.K. Power Cord for Instrument 50214149 Filter Holder 50546216 Cartridge Return Spring 625-0127-01 Fuse: T-1.25A, Slow Blow; 250V 95001901 Cleaning Kit 95002911 Optical T est Cartridge 95002117 Air Filter (8) Replacement Kit 95002836 Operating Manual

NOTE: Part numbers are subject to change without notice.

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 plc MERA (Middle East, Eastern Europe, Russia, Africa) Bayer House Strawberry Hill Newbury Berkshire RG14 1JA UK +44 1635 563000

Bayer Inc. Diagnostics Division Toronto, Ontario M9W 1G6

Bayer (South East Asia), Pte Ltd No.9 Benoi Sector Singapore 629844 Tel: (65) 6261 3389 Fax: (65) 6266 3376

Bayer Australia Ltd. ABN 22 000 138 714 Diagnostics Division 875 Paciﬁc Hwy Pymble NSW 2073 AUSTRALIA 1 800 028 251 (toll free)

Revised 6/03 App. 1.1

APPENDIX

OPTICAL TEST CARTRIDGE RESULTS

Initial V alues

Date Mean Transmittance Standard Deviation Drift

DA TE MEAN TRANSMITTANCE STANDARD DEVIATION DRIFT

Comparing New Values With Initial Values

Compare the new values obtained with the initial values. 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 Drift should be less than 0.01400.

Revised 6/03 Index 1.1

APPENDIX

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

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

ﬁnger: 4.6 foil: 4.3 format: 3.2

glutaraldehyde: 7.2 grounded: 2.4

humidity: 1.1, 2.4

important: 2.3 insert: 5.4 installation: 1.1 IVD: 1.1

laboratories: 1.1

mechanical: 2.5 memory: 2.8 menu: 2.8 mg/dL: 2.16 mmol/L: 2.16

operational: 1.1 optical: 2.1

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

Index 1.2 Revised 6/03

APPENDIX

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

tab: 2.2 temperature: 1.1, 2.4

unpacking: 2.8 urine: 1.1, 5.6 use by: 1.2

venipuncture: 4.6

warning: 1.1, 4.5 warranty: 1.1

INDEX

Bayer DCA 2000+ User manual

Specifications and Main Features

Frequently Asked Questions

User Manual