Escolar Documentos
Profissional Documentos
Cultura Documentos
g
n
i
t
a
r
e
Op nual
Ma
50241739
ii
Revised 6/03
TABLE OF CONTENTS
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
Revised 6/03
iii
7.1
7.1
7.2
7.3
7.4
7.6
Revised 6/03
INTRODUCTION
INTENDED USE
The DCA 2000 Analyzer quantitatively
measures:
FEATURES
easily calibrated using the bar code card
provided with each reagent kit
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
SPECIFICATIONS
Power Required:
Instrument Model No. 5031C: 100240 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)
WARRANTY INFORMATION
Contact your Authorized Bayer Representative for
complete warranty information.
(1532C)Hemoglobin A1c
15
30
18
(1830C)Microalbumin/Creatinine
1.1
INTRODUCTION
1
INTRODUCTION
SYMBOLS USED
The following symbols are used throughout the product labeling for the DCA 2000 System (Instrument,
Instrument Manual, Quick Reference Guide, DCA Reagent Labeling and Instructional inserts and the
DCA Control packaging and instructional inserts).
Catalog number
In vitro diagnostic device
Fuse
Quantity
Menu/Next
(EXP) Use by
Increase
Warning/Attention: consult
instructions for use
Decrease
Enter
8
2
Reagent cartridge
Temperature limitations
Escape
Do not use spray
Manufactured by
Normal control
EC REP
Authorized representative
Abnormal control
Calibration card
High control
Optical test cartridge
Low control
Do not freeze
Reconstitution fluid
High temperature part
U.S. PATENTS
6,043,043, 5,822,071, 5,610,073, 5,385,847, 5,372,948, 5,305,093, 5,272,093, 5,258,311, 5,220,161,
5,162,237, 5,151,369, 5,084,397, 4,990,075, 4,970,171, 4,968,472, 4,898,824, 4,847,209, 4,727,036,
4,658,022, 4,647,654, 4,629,692, D400,673.
1.2
Revised 6/03
UNPACKING, GETTING
ACQUAINTED AND SET UP
UNPACKING
UNPACKING, GETTING
ACQUAINTED AND SET UP
CARTON CONTENTS
1
2
3
Cleaning Kit*
Optical Test Cartridge
(in instrument cartridge compartment)
Program Card*
Revised 6/03
4
3
2.1
GETTING ACQUAINTED
1
2
UNPACKING, GETTING
ACQUAINTED AND SET UP
5
6
2.2
AUDIBLE TONES
4
2
5
7
BACK PANEL
1
2
3
4
5
6
UNPACKING, GETTING
ACQUAINTED AND SET UP
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
Revised 6/03
2.3
UNPACKING, GETTING
ACQUAINTED AND SET UP
SET UP
2.4
Revised 6/03
is displayed.
SOFTWARE VERSION
E3.11/01.04
Then:
*
INITIALIZING
KEEP DOOR CLOSED
Then:
INSTRUMENT SETUP
--] TO CONTINUE
PRESS [<
Revised 6/03
2.5
UNPACKING, GETTING
ACQUAINTED AND SET UP
INSTRUMENT SETUP
PRESS [<
--] TO CONTINUE
1 1 4 0 00000000000000
T D L C P0000000000000
NUMBER
DEFINITION
(Time)
D (Date)
Month/Day/Year
L (Labels
displayed
(0)
with results) (0)
(0)
C (Controls)
(0)
P (Port)
(0)
AM/PM
2.6
Revised 6/03
2
UNPACKING, GETTING
ACQUAINTED AND SET UP
Revised 6/03
2.7
OPTIONS
UNPACKING, GETTING
ACQUAINTED AND SET UP
SETTING NUMBER
(Time
Format)
1*
2
AM/PM*
24 hour format
D (Date
Format)
1*
2
3
Month/Day/Year*
Day Month Year
YearMonthDay
0
1
No labels
Sequence number
(reset daily, automatically at midnight)
Sequence number
(continuous, 001 999)
Time assay began
Time assay began; sequence number
(reset daily, automatically at midnight)*
Time assay began; sequence number
(continuous, 001 999)
(Labels displayed
with results)
2
3
4*
5
C (Controls)
0*
2.8
Revised 6/03
OPTION
P
(Computer Port
Configuration)
SETTING NUMBER
0*
ON
2
UNPACKING, GETTING
ACQUAINTED AND SET UP
(Baud Rate)
9*
4
2
1
3
9600 bps*
4800 bps
2400 bps
1200 bps
300 bps
U (Data Bits)
8*
7
8 bits*
7 bits
V (Parity)
0*
1
2
None*
Odd
Even
W (Stop Bits)
1*
2
1*
2
X (XonXoff
Protocol)
0*
1
Off*
On
Y (Block
Transfer)
0
1*
Off
On*
0*
1
Off*
On
(Modem
Control)
Revised 6/03
2.9
UNPACKING, GETTING
ACQUAINTED AND SET UP
DISPLAY
1 1 4 0 0 mmmmmmmmmmmm
T D L C P mmmmmmmmmmmm
1 1 4 0 0 mmmmmmmmmmmm
TIME FORMAT
AM/PM
2.10
*Cursor
The cursor is the underline in the display. The
cursor shows you which setting is ready for
change.
1 1 4 0 0 nnnnnnnnnnnn
TIME FORMAT
AM/PM
WHAT YOU 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).
Revised 6/03
DISPLAY
1 1 4 0 0 mmmmmmmmmmmm
DATE FORMAT
MM/DD/YY
1 1 4 0 0 mmmmmmmmmmmm
CONTROLS
DCA 2000
1 1 4 0 0mm mmmmmmmmmm
COMPUTER PORT OFFmmmmm
3. Press
and
to cycle through choices for
DATE 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
2.82.9.
(accepts all settings and
0. Press
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.
Revised 6/03
2.11
2
UNPACKING, GETTING
ACQUAINTED AND SET UP
1 1 4 0 0 mmmmmmmmmmmm
LABELS USED TIME/DAILY
WHAT YOU DO
UNPACKING, GETTING
ACQUAINTED AND SET UP
DISPLAY
WHAT YOU DO
1 1 4 0
2 9801110
COMPUTER PORT ON
2.12
1 1 4 0
BAUD RATE
2 9801010
9600
1 1 4 0
DATA BITS
2 9801110
EIGHT
1 1 4 0
PARITY
2 9801010
NONE
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).
Revised 6/03
DISPLAY
1 1 4 0
STOP BITS
2 9821010
ONE
2 9821010
OFF
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).
1 1 4 0
BLOCK XFER
2 9821000
OFF
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).
1 1 4 0
MODEM
2 9801110
OFF
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).
Revised 6/03
2.13
2
UNPACKING, GETTING
ACQUAINTED AND SET UP
1 1 4 0
XON/XOFF
WHAT YOU DO
UNPACKING, GETTING
ACQUAINTED AND SET UP
DISPLAY
SET DATE/TIME
02/24/03
6:20AM
WHAT YOU DO
The display on your instrument is displaying the
date and time in your chosen format.
1. Press
or
displayed.
0. Press .
SET DATE/TIME
02/24/03
6:20AM
SET DATE/TIME
02/24/03
6:20AM
2.14
2. Press
or
displayed.
0. Press .
3. Press
or
displayed.
0. Press .
Revised 6/03
DISPLAY
WHAT YOU DO
SET DATE/TIME
02/24/03
6:20AM
SET DATE/TIME
02/24/03
6:20AM
AM or PM if AM/PM
format is selected
Revised 6/03
5. Press
or
displayed.
.
.
2.15
2
UNPACKING, GETTING
ACQUAINTED AND SET UP
AM or PM if AM/PM
format is selected
4. Press
or
displayed.
0. Press .
UNPACKING, GETTING
ACQUAINTED AND SET UP
DISPLAY
READY: SCAN BAR CODE
02/24/03
2:09PM
2.16
WHAT YOU DO
1. Press
0.
2. Repeatedly press
, until
SET CREATININE UNITS? is displayed.
4. Press
or
mg/dL.
to display mmol/L or
5. Press
6. Press
Revised 6/03
DISPLAY
WHAT YOU DO
RUN STANDARD 1?
Revised 6/03
5. Press
2.17
2
UNPACKING, GETTING
ACQUAINTED AND SET UP
WHAT YOU DO
STANDARD 1
LOAD, CLOSE DOOR
UNPACKING, GETTING
ACQUAINTED AND SET UP
2.18
Revised 6/03
MENU
The MENU consists of up to nine (9) items
listed below. Note that item number two and item
number nine are optional (may or may not be
activedepends upon choices made during
Instrument Setup).
1
2
Press
To display each additional item:
Repeatedly press
RECALL CONTROL RESULTS?
To select the item displayed:
SET DATE/TIME?
Press
To exit the MENU:
Press
INSTRUMENT SETUP?
INSTRUMENT TEST?
Revised 6/03
3
MENU
3.1
MENU
Assay Result
Test
Type
MENU
6.0 % HbA1c
LOT:0325
02/24/03 #011 11:24PM
of Assay
Date Date
of Assay
Date of Assay
DISPLAY
Sequence No.
No.
Sequence
(optional)
(optional)
Time
Assay
Began
Time
Assay
Began
Time A. (optional)
WHAT YOU DO
WAIT: WARMING UP
02/24/03
2:09PM
1. Press
OR
READY: SCAN BAR CODE
02/24/03
2:09PM
OR
TEST IN PROGRESS
#001
6 MIN 10:15AM
3.2
Revised 6/03
DISPLAY
WHAT YOU DO
6.0 % HbA1c
LOT:0325
02/24/03 #011 11:24PM
(example)
OR
(example)
OR
3. Press
NOTES:
(if a printer
To print the displayed test result, press
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.
C=72.1mg/dL
LOT:0325
09/13/02 #010 10:24PM
(example)
OR
A/C=76
02/24/03
LOT:0325
#010 10:24PM
(example)
NO MORE RESULTS STORED
IN INSTRUMENT
Revised 6/03
3.3
MENU
A=55.0mg/L
LOT:0325
09/13/02 #010 10:24PM
2. Press .
0. The test result for the sample most recently
assayed is displayed first.
MENU
DISPLAY
WHAT YOU DO
WAIT: WARMING UP
02/24/03
2:09PM
OR
READY: SCAN BAR CODE
02/24/03
2:09PM
1. Press
2. Press
MENU
OR
TEST IN PROGRESS
#001
6 MIN 10:15AM
3. Press
4. Press
cursor.
or
0. Press
0. digit.
3.4
Revised 6/03
MENU
Test
Control Result
Reagent Lot Number
Type
mmmmmmmmmmmmmmmmmmmmmmmmm
9.8% HbA1c
LOT:0325
02/24/03 C1 LOTC:0223
Date of Assay
**Clis replaced with C2 for the DCA 2000 Abnormal or High Control and
C1out or C2out for an out-of-range control
Date of Assay
c1indicates control
level 1 of 9 possible
levels
*unless a DCA 2000 Control was run without scanning the DCA 2000
Control bar code card provided with the control kitmmmmmmmmn
3.5
MENU
Recall Control Results
WHAT YOU DO
DISPLAY
WAIT: WARMING UP
02/24/03
2:09PM
OR
1. Press
MENU
OR
TEST IN PROGRESS
#001
6 MIN 10:15AM
3.6
3. Press .
0. The control result for the control most
recently assayed is displayed first.
Revised 6/03
DISPLAY
WHAT YOU DO
9.8% HbA1c
02/24/03 C1
LOT:0325
LOTC:0223
4. Press
to recall up to 16 control
0. results.
(example)
OR
A=24.6mg/L
02/24/03 C2
LOT:0105
LOTC:0345
OR
C=54.1mg/dL
02/24/03 C2
LOT:0105
LOTC:0345
(example)
Reminder: Upper case C indicates
result for a DCA 2000 Control
NO MORE CONTROLS STORED
IN INSTRUMENT
Revised 6/03
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.
3.7
3
MENU
(example)
NOTES:
(if a printer is
To print the control result, press
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.
twice.
To exit the MENU, press
Albumin
(A)
and
creatinine
(C)
for the same control
MENU
WHAT YOU DO
DISPLAY
WAIT: WARMING UP
02/24/03
2:09PM
1. Press .
0. (A test in progress is not aborted.)
MENU
OR
READY: SCAN BAR CODE
02/24/03
2:09PM
OR
TEST IN PROGRESS
#001
6 MIN 10:15AM
3.8
3. Press .
0. The calibration status for the most recent
calibration is displayed first.
Revised 6/03
DISPLAY
WHAT YOU DO
LOT:0183
02/24/03
HbA1c
11:23PM
4. Press
to recall status of each
0. calibration stored.
(example)
OR
LOT:0222
02/24/03
Malb/C
11:30PM
NOTES:
To return display to VIEW CALIBRATION
STATUS?, press
once anytime during calibration
status recall.
twice.
To exit the MENU, press
NO MORE CALIBRATIONS
STORED IN INSTRUMENT
Revised 6/03
MENU
(example)
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.
3.9
MENU
SET DATE/TIME?
3
MENU
SET DATE/TIME...
02/24/03
6:20AM
DISPLAY
WHAT YOU DO
WAIT:WARMING UP
02/24/03
2:09PM
OR
1. Press
2. Repeatedly press
until
0. SET DATE/TIME? is displayed.
SET DATE/TIME?
02/24/03
6:19AM
3.10
3. Press
Revised 6/03
DISPLAY
WHAT YOU DO
SET DATE/TIME
02/24/03
6:20AM
SET DATE/TIME
02/24/03
6:20AM
5. Press
or
displayed.
0. Press .
SET DATE/TIME
02/24/03
6:20AM
6. Press
or
until the correct two digits are
displayed.
0. Press . The cursor will move back to the first
digit of the date
3
MENU
7. Press
to advance the cursor to the time
setting.
SET DATE/TIME
02/24/03
6:20AM
AM or PM if AM/PM
format is selected
SET DATE/TIME
02/24/03
6:20AM
AM or PM if AM/PM
format is selected
8. Press
or
displayed.
0. Press .
9. Press
or
displayed.
0. Press .
3.11
MENU
3
(This page left blank on purpose.
Intended for future use.)
3.12
Revised 6/03
INSTRUMENT SETUP?
DISPLAY
WHAT YOU DO
WAIT: WARMING UP
02/24/03
2:09PM
OR
1. Press
OR
TEST IN PROGRESS
#001
6 MIN 10:15AM
INSTRUMENT SETUP?
1 1 4 0 0 MMMMMMMMMMM
T D L C P MMMMMMMMMMM
3. Press
1 1 4 0 2 9801010mmmmm
T D L C P BUVWXYZmmmmm
Revised 6/03
3.13
MENU
WHAT YOU DO
1 1 4 0 0 9801010mmmmm
T D L C Pmmmmmmmmmmmmm
5. Press
(places a cursor under the
0. setting for the first option, TIME FORMAT).
MENU
1 1 4 0 2 9801010mmmmm
T D L C P BUVWXYZmmmmm
1 1 4 0 0 mmmmmmmmmmmm
TIME FORMAT
AM/PM
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).
1 1 4 0 2 9801010mmmmm
T D L C P BUVWXYZmmmmm
1 1 4 0 0 mmmmmmmmmmmm
T D L C P Mmmmmmmmmmmm
Revised 6/03
DISPLAY
READY: SCAN BAR CODE
02/24/03
2:09PM
WHAT YOU DO
1. Press
0.
MENU
2. Repeatedly press
, until
SET CREATININE UNITS? is displayed.
4. Press
or
mg/dL.
Revised 6/03
to display mmol/L or
5. Press
6. Press
3.15
MENU
MENU
INSTRUMENT TEST?
3.16
Revised 6/03
DISPLAY
WHAT YOU DO
1. Press
MENU
3
.
2. Repeatedly press
until
0. RUN CONTROL? is displayed.
RUN CONTROL?
02/17/90 #001 11:47AM
Revised 6/03
3. Press
4. Press
or
until the desired
control number (choices 19) is displayed.
0. Press .
3.17
WHAT YOU DO
9.8% HbA1c
LOT:0183
02/17/90 #001 11:47AM
4
OPERATING INSTRUCTIONS
HEMOGLOBIN A1C
SOFTWARE VERSION
E3.11/01.04
WAIT: WARMING UP
02/24/03
2:09PM
(a beep is heard)
Revised 6/03
4.1
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 A1c Reagent Kit)
NOTES:
The instrument stores up to two calibrations
for the DCA 2000 Hemoglobin A1c 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
WHAT YOU DO
4
OPERATING INSTRUCTIONS
HEMOGLOBIN A1C
OR
Any result or menu display
as long as testing is not in progress.
Revised 6/03
OPTICAL
WINDOW
4.3
OPERATING INSTRUCTIONS
HEMOGLOBIN A1C
absorbent pad
0.
glass capillary
0.
latching mechanism
0.
1
OPERATING INSTRUCTIONS
HEMOGLOBIN A1C
0.
4.4
Revised 6/03
4
OPERATING INSTRUCTIONS
HEMOGLOBIN A1C
EITHER
For a Patient Sample or any
control other than
DCA 2000 Control Steps 1 through 9 under WHAT
YOU DO on pages 4.8-4.9
OR
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.
Revised 6/03
4.5
OPERATING INSTRUCTIONS
HEMOGLOBIN A1C
B) 0.
4.6
Revised 6/03
4
OPERATING INSTRUCTIONS
HEMOGLOBIN A1C
Revised 6/03
4.7
WHAT YOU 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.
OPERATING INSTRUCTIONS
HEMOGLOBIN A1C
0.
4.8
Revised 6/03
DISPLAY
LOAD CARTRIDGE
PULL TAB, CLOSE DOOR
WHAT 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 kytettess
0.
0.
OPERATING INSTRUCTIONS
HEMOGLOBIN A1C
Revised 6/03
4.9
WHAT YOU DO
TEST IN PROGRESS
#001
6 MIN 10:15AM
9.8
%HbA1c
mmm
#001 10:21
OPERATING INSTRUCTIONS
HEMOGLOBIN A1C
4.10
Revised 6/03
RESULTS:
The displayed test result requires no further
calculation. Hemoglobin A1c 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 A1c. This method does not
provide for re-assay using a larger sample aliquot.
Results less than 2.5% Hemoglobin A1c 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).
4
OPERATING INSTRUCTIONS
HEMOGLOBIN A1C
Revised 6/03
4.11
DISPLAY
READY: SCAN BAR CODE
02/24/03
2:09PM
OPERATING INSTRUCTIONS
HEMOGLOBIN A1C
WHAT YOU DO
1. Locate the dot (on the instrument) next to the
bar code track.
2. Locate the bar code on the control card.
0. 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
4.12
6. Press
Revised 6/03
DISPLAY
SCAN BAR CODE:
HbA1c
02/24/03
C1 11:10AM
WHAT YOU 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).
Revised 6/03
4.13
OPERATING INSTRUCTIONS
HEMOGLOBIN A1C
LOAD CONTROL
PULL TAB, CLOSE DOOR
WHAT YOU DO
PROCESSING CONTROL
C1-HbA1c 6 MIN 11:11AM
4
OPERATING INSTRUCTIONS
HEMOGLOBIN A1C
5.1
%HbA1cmmmmm
C1 10:21AM
OR
For a result outside the acceptable control
range printed in the control package insert
CONTROL OUT OF RANGE
PRESS [ESC] TO PROCEED
15.
4.14
Revised 6/03
CANCELLING A TEST
You may cancel a test anytime.
Important: If a test in progress is cancelled, the
test must be discarded.
DISPLAY
WHAT YOU DO
LOAD CARTRIDGE
PULL TAB, CLOSE DOOR
1. Press
OR
4
OPERATING INSTRUCTIONS
HEMOGLOBIN A1C
TEST IN PROGRESS
#001
6 MIN 10:15AM
CANCEL TEST?
PRESS [<--] TO CONFIRM
2. Press
within 15 seconds.
, PLEASE WAIT
is displayed until the cartridge returns to original
loading position.
0. If
is not pressed within 15 seconds:
0. the display returns to the original display
(i.e., either display shown in Step 1).
0. the test in progress continues without
interruption
Revised 6/03
4.15
WHAT YOU DO
4
OPERATING INSTRUCTIONS
HEMOGLOBIN A1C
ORmm
0. Open cartridge compartment door and
remove cartridge.
4.16
Revised 6/03
WHAT YOU DO
9.8% HbA1c
LOT:0183
02/17/90 #001 11:47AM
SOFTWARE VERSION
E3.11/01.04
OPERATING INSTRUCTIONS
MICROALBUMIN/CREATININE
COPYRIGHT 1991-2003
BY BAYER CORPORATION
WAIT: WARMING UP
02/24/03
2:09PM
(a beep is heard)
Revised 6/03
5.1
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.
DISPLAY
WHAT YOU DO
5
OPERATING INSTRUCTIONS
MICROALBUMIN/CREATININE
OR
Any result or menu display
as long as testing is not in progress.
5.2
Revised 6/03
DISPLAY
WHAT YOU DO
5. Quickly (within 1 sec.) and smoothly, slide
the card down past the dot.
0. A beep sounds to signal a successful scan.
0. If no beep sounds, repeat procedure. If a
beep repeatedly fails to sound, refer to
Troubleshooting, Section 6.
5.3
5
OPERATING INSTRUCTIONS
MICROALBUMIN/CREATININE
Revised 6/03
OPERATING INSTRUCTIONS
MICROALBUMIN/CREATININE
OPTICAL
WINDOW
Revised 6/03
absorbent pad
0.
glass capillary
0.
latching mechanism
0.
starch plug
0.
1
OPERATING INSTRUCTIONS
MICROALBUMIN/CREATININE
3
4
plunger
Revised 6/03
5.5
OPERATING INSTRUCTIONS
MICROALBUMIN/CREATININE
5
OPERATING INSTRUCTIONS
MICROALBUMIN/CREATININE
Revised 6/03
5.7
WHAT YOU 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.
0.
OPERATING INSTRUCTIONS
MICROALBUMIN/CREATININE
5
5. Quickly (within 1 sec.) and smoothly, slide
the reagent cartridge down past the dot.
0. A beep sounds to signal a successful scan.
0. If no beep sounds, repeat procedure. If a
beep repeatedly fails to sound, refer to
Troubleshooting, Section 6.
5.8
Revised 6/03
DISPLAY
LOAD CARTRIDGE, INSERT
PLUNGER, PRESS [<--]
WHAT 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
OPERATING INSTRUCTIONS
MICROALBUMIN/CREATININE
5.9
DISPLAY
TEST IN PROGRESS
#001
6 MIN 10:15AM
C=141mg/dL
#001 10:17AM
OPERATING INSTRUCTIONS
MICROALBUMIN/CREATININE
5.10
Revised 6/03
RESULTS:
Revised 6/03
5.11
5
OPERATING INSTRUCTIONS
MICROALBUMIN/CREATININE
DISPLAY
WHAT YOU DO
OPERATING INSTRUCTIONS
MICROALBUMIN/CREATININE
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
5.12
6. Press
Revised 6/03
DISPLAY
SCAN BAR CODE
02/24/03
C1
WHAT YOU DO
Malb/C
11:10AM
5.13
OPERATING INSTRUCTIONS
MICROALBUMIN/CREATININE
DISPLAY
PROCESSING CONTROL
C1-Malb/C 7 MIN 11:11AM
C=141 mg/dL
C1 11:11AM
OR
OPERATING INSTRUCTIONS
MICROALBUMIN/CREATININE
5.14
Revised 6/03
CANCELLING A TEST
You may cancel a test anytime.
Important: If a test in progress is cancelled, the
test must be discarded.
DISPLAY
WHAT YOU DO
1. Press
OR
PULL TAB, CLOSE DOOR
OR
TEST IN PROGRESS
#001
6 MIN 10:15AM
OPERATING INSTRUCTIONS
MICROALBUMIN/CREATININE
CANCEL TEST?
PRESS [<--] TO CONFIRM
2. Press
within 15 seconds.
, PLEASE WAIT is
displayed until the cartridge returns to original
loading position.
0. If
is not pressed within 15 seconds:
0. the display returns to original display (i.e.,
either display shown in Step 1).
0. the test in progress continues without
interruption
5.15
DISPLAY
READY: SCAN BAR CODE
02/24/03
2:09PM
ORmm
0. Open cartridge compartment door and
remove cartridge.
OPERATING INSTRUCTIONS
MICROALBUMIN/CREATININE
5.16
Revised 6/03
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
Hemoglobin A1c
Microalbumin / Creatinine
ERROR 101 ........................ 6.6
ERROR 301 ........................ 6.8
ERROR 102 ........................ 6.6
ERROR 302 ........................ 6.8
ERROR 103 ........................ 6.6
ERROR 303 ........................ 6.8
ERROR 104 ........................ 6.6
ERROR 304 ........................ 6.8
ERROR 105 ........................ 6.6
ERROR 305 ........................ 6.8
ERROR 106 ........................ 6.6
ERROR 306 ........................ 6.8
ERROR 107 ........................ 6.6
ERROR 307 ........................ 6.8
ERROR 108 ........................ 6.7
ERROR 308 ........................ 6.8
ERROR 109 ........................ 6.7
ERROR 309 ........................ 6.9
ERROR 110 ........................ 6.7
ERROR 310 ........................ 6.9
ERROR 111 ........................ 6.7
ERROR 311 ........................ 6.9
ERROR 112 ........................ 6.7
ERROR 313 ........................ 6.9
ERROR 113 ........................ 6.7
ERROR 315 ........................ 6.9
ERROR 114 ........................ 6.7
ERROR 316 ........................ 6.9
ERROR 115 ........................ 6.7
ERROR 116 ........................ 6.7
TROUBLESHOOTING
..................................................................................................... 6.10
Revised 6/03
6.1
CAUSE
SOLUTION
Close door.
Wait for next display PLEASE WAIT.
1.
0.
0.
2.
0.
0.
0.
0.
0.
0.
PLEASE WAIT
02/17/90 #001 11:47AM
6.2
Revised 6/03
ERROR OR WARNING
CAUSE
SOLUTION
Press
key.
INSTRUMENT SETUP/PRESS
[<--] 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.
*OR:
ERROR 2xOPTICAL
ERROR 3xTEMPERATURE
ERROR 4xBAR CODE
ERROR 9xINTERNAL
Revised 6/03
6.3
6
ERROR AND WARNING MESSAGES,
ERROR CODES & TROUBLESHOOTING
WRONG CARD
ERROR CODES
ERROR CODE
E1
E2
E3
CAUSE
SOLUTION
1.
0.
0.
0.
0.
2.
0.
0.
0.
3.
0.
0.
0.
0.
0.
0.
0.
0.
0.
0.
3.
0.
0.
0.
6.4
Revised 6/03
ERROR CODE
E4
SOLUTION
1.
0.
0.
0.
2.
3.
0.
0.
0.
0.
0.
0.
0.
0.
0.
0.
0.
1.
2.
3.
0.
0.
0.
4.
0.
0.
0.
0.
2.
0.
0.
3.
0.
0.
E5
E6
Revised 6/03
6.5
6
ERROR AND WARNING MESSAGES,
ERROR CODES & TROUBLESHOOTING
CAUSE
ERROR CODE
CAUSE
SOLUTION
101
No cartridge present.
Optical alignment problem.
102
Buffer Reading Out of Limits Low
103
Condensation on cartridge
cartridge not allowed to warm up
Rare.
Particulate contamination.
If problem persists, contact Bayer
HealthCare Customer Service Department.
See Section 9, Service Information.
104
106
Reading for Hemoglobin Value Low
105
107
Reading for Hemoglobin Value High
6.6
Revised 6/03
ERROR CODE
CAUSE
SOLUTION
108
Rare.
Particulate contamination.
109
110
111
112
Readings for Glycated Hemoglobin
Out of Limits
113
Particulate contamination.
114
116
Irregular Reaction Kinetics
for Glycated Hemoglobin
Blood left too long in capillary.
115
Revised 6/03
6.7
ERROR CODE
CAUSE
301
No cartridge present.
Optical alignment problem.
302
Buffer Mean Out of Limits High
Absorbance
303
SOLUTION
Repeat test with cartridge in place.
If problem persists, contact Bayer
HealthCare Customer Service Department.
See Section 9, Service Information.
Rare.
Particulate contamination.
Particulate contamination.
Repeat test.
If problem persists, contact Bayer HealthCare
Customer Service Department. See Section 9,
Service Information.
Rare.
Particulate contamination.
Repeat test.
If problem persists, contact Bayer HealthCare
Customer Service Department. See Section 9,
Service Information.
Rare.
Cartridge exposed to excessive
temperature and/or humidity.
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
6.8
Revised 6/03
ERROR CODE
CAUSE
SOLUTION
309
Rare.
Particulate contamination.
Repeat test.
If problem persists, contact Bayer
HealthCare Customer Service Department.
See Section 9, Service Information.
Rare.
Cartridge exposed to excessive
temperature and/or humidity.
313
Particulate contamination.
315
310
311
Readings for Creatinine
Out of Limits
Revised 6/03
6.9
6
ERROR AND WARNING MESSAGES,
ERROR CODES & TROUBLESHOOTING
316
TROUBLESHOOTING
PROBLEM
SOLUTION
1.
0.
2.
0.
0.
0.
6.10
Revised 6/03
INSTRUMENT CARE
AND ROUTINE MAINTENANCE
INSTRUMENT CARE
The DCA 2000 Analyzer contains sensitive
electronics and optics.
(1532C)Hemoglobin A1c
15
30
18
(1830C)Microalbumin/Creatinine
Exterior
Bar Code Window
Cartridge Compartment
Change Air Filter
Run Optical Test Cartridge
Exterior
Change Air Filter
Cartridge Compartment
Bar Code Window
Run Optical Test Cartridge
INSTRUMENT CARE
AND ROUTINE MAINTENANCE
Weekly
Revised 6/03
7.1
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.
INSTRUMENT CARE
AND ROUTINE MAINTENANCE
10 mL of household bleach + 90 mL of
water or alternatively:
1 part household bleach + 9 parts water
7.2
Revised 6/03
Firetl
Horedl
Revised 6/03
INSTRUMENT CARE
AND ROUTINE MAINTENANCE
riA
Firetl
Firetl
Horedl
7.3
CARTRIDGE
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
kasettipesn.
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.
0. Dry surfaces using a clean, dry, lint-free
cloth.
3. Locate the cartridge return spring inside the
cartridge holder. Note top and bottom holes.
LEAF SPRINGS
0.
7
INSTRUMENT CARE
AND ROUTINE MAINTENANCE
TOP
HOLE
CARTRIDGE
RETURN
SPRING
7.4
BOTTOM
HOLE
Revised 6/03
00.
7.5
7
INSTRUMENT CARE
AND ROUTINE MAINTENANCE
00.
DISPLAY
WHAT YOU DO
INSTRUMENT CARE
AND ROUTINE MAINTENANCE
7
RUN STANDARD 1?
7.6
5. Press
Revised 6/03
DISPLAY
WHAT YOU DO
STANDARD 1
LOAD, CLOSE DOOR
PROCESSING STANDARD
S1
6 MIN
10:02AM
7
INSTRUMENT CARE
AND ROUTINE MAINTENANCE
Revised 6/03
7.7
DISPLAY
Upon completion of test:
1.0001 T 0.00012 SDmm
S1
0.00387 DRIFT
INSTRUMENT CARE
AND ROUTINE MAINTENANCE
7.8
Revised 6/03
MINOR REPAIR
You can:
replace the fuse
If your instrument requires any other type of
repair, refer to Section 9, Service Information.
1
2
replacement fuse
1.
blown fuse
fuse block
0.
Groove
8
MINOR REPAIR
Revised 6/03
8.1
SERVICE INFORMATION
3.
0.
0.
0.
0.
YES
NO
SOFTWARE VERSION
E3.11/01.04
First
Record the following information.
Instrument Serial Number ___________________
Installation Date___________________________
INITIALIZING
KEEP DOOR CLOSED
xWAIT: WARMING UP
02/24/03
2:09PM
Current
_______
_______
_______
Second
Complete the following Preservice Questionnaire.
1. Has Section 6, Trouble0. shooting been reviewed?
YES
NO
YES
NO
4.
0.
0.
0.
0.
0.
0.
Revised 6/03
YES
NO
YES
NO
YES
NO
9.1
SERVICE INFORMATION
SERVICE INFORMATION
SERVICE INFORMATION
6. If your instrument is connected
0. to a printer or computer,
are all cables securely
attached?
YES
NO
Third
Contact the nearest Bayer Diagnostics office or
authorized distributor.
9.2
Revised 6/03
9
REPLACEMENT PARTS
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
Bayer House
Strawberry Hill
Newbury, Berkshire
RG14 1JA UK
Ascensia Diabetes Support
0845 600 6030UK
1 890 920 111Republic 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
Revised 6/03
9.3
SERVICE INFORMATION
ACCESSORY ITEMS
APPENDIX
OPTICAL TEST CARTRIDGE RESULTS
DATE
Revised 6/03
MEAN TRANSMITTANCE
DRIFT
App. 1.1
APPENDIX
Initial Values
Date
Mean Transmittance
Standard Deviation
Drift
INDEX
A
aborted: 3.8
air: 2.4
analysis: 2.2
analyze: 2.6
assay: 2.3
authorized: 1.1
glutaraldehyde: 7.2
grounded: 2.4
APPENDIX
H
humidity: 1.1, 2.4
I
important: 2.3
insert: 5.4
installation: 1.1
IVD: 1.1
L
C
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
D
definition: 3.13
displayed: 2.3
E
electrical: 1.1, 2.4
electronic: 2.1
error: 6.1
F
finger: 4.6
foil: 4.3
format: 3.2
Revised 6/03
laboratories: 1.1
M
mechanical: 2.5
memory: 2.8
menu: 2.8
mg/dL: 2.16
mmol/L: 2.16
O
operational: 1.1
optical: 2.1
P
power: 2.1
printer: 1.1, 3.16
procedures: 4.3
progress: 3.8
prompts: 2.2
R
ratio: 3.3
reagent: 1.1
recall: 3.7
reconstitution: 1.2
Index 1.1
INDEX
APPENDIX
S
safety: 1.1
sequence: 2.8, 3.4
sodium hypochlorite: 7.2
software version: 2.5
specifications: 1.1
spring: 2.2
standards: 1.1
sunlight: 2.4
T
tab: 2.2
temperature: 1.1, 2.4
U
unpacking: 2.8
urine: 1.1, 5.6
use by: 1.2
V
venipuncture: 4.6
W
warning: 1.1, 4.5
warranty: 1.1
Index 1.2
Revised 6/03