Bayer DCA 2000+ User manual
Analyzer
Operating
Manual
®
50241739 ii Revised 6/03
© 2003 Bayer HealthCare LLC
All Rights Reserved
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
1c
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
1c
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
1c
(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.
1
INTRODUCTION
32
15
18
30
1
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.
2
8
EC REP
2
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
1c
Quick Reference Guide*
6
5
4
3
2
1
UNPACKING, GETTING
ACQUAINTED AND SET UP
1
2
5
4
3
Missing Items?...Contact the nearest Bayer
HealthCare office or authorized distributor.
2
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
6
5
4
3
2
1
1
6
5
2
3
4
➠
2
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.
7
6
5
4
3
2
1
1
2
3
5
4
6
7
2
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.
0.
•
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).
2
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)
•
Copyright information is displayed for 3
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
COPYRIGHT 1991–2003
BY BAYER CORPORATION
SOFTWARE VERSION
E3.11/01.04
2
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
2
UNPACKING, GETTING
ACQUAINTED AND SET UP
Revised 6/03 2.7
(This page left blank on purpose.
Intended for future use)
2
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).
2
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*
22
X (Xon—Xoff 0* Off*
Protocol)
1On
Y (Block 0 Off
Transfer)
1* On*
Z (Modem 0* Off*
Control) 1 On
2
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
2
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:
0.
•
Check to make sure all numbers on Line 1
reflect your choices.
0.
• Reminder: Options Chart is found on pages
2.8–2.9.
0.
•
Press (accepts all settings and
0.
• advances display to SET DATE/TIME?)
0.
•
Continue with instructions on page 2.14,
“Setting the Date and Time.”
0. If you have selected “2” for
COMPUTER PORT ON:
0.
•
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
2
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
2
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.
0.
•
Check to make sure all numbers on Line 1
represent desired settings.
0.
•
Press (accepts all settings and
0.
• 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
2
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
2
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.
0.
•
If 24 HR format is selected, press .
0.
•
If AM/PM format is selected, press .
0.
• Then 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
2
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 .
0.
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
2
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.
0.
•
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
2
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
3
MENU
MENU
The MENU consists of up to nine (9) items
listed below. Note that item number two and item
number nine are optional (may or may not be
active—depends upon choices made during
“Instrument Setup”).
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.
9
8
7
6
5
4
3
2
1
3.2 Revised 6/03
3
MENU
MENU
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
1
DISPLAY
OR
OR
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
3
MENU
DISPLAY
(example)
OR
(example)
OR
(example)
OR
(example)
(after all results are displayed)
WHA T Y OU DO
2. Press .
0.
•
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
3
MENU
MENU
SET SEQUENCE NUMBER? (optional)
2
DISPLAY
OR
OR
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.
0.
•
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
3
MENU
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
3
• 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
3
MENU
MENU
Recall Control Results
DISPLAY
OR
OR
WHA T Y OU DO
1. Press .
2. Repeatedly press , until “RECALL
CONTROL RESULTS?” is displayed.
(Test in progress is not aborted.)
3. Press .
0.
•
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
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