Overview 1-1

1 Overview

Intended Use
The DCA Vantage is a semi-automated, benchtop system. It is designed to quantitatively
measure the percent of Hemoglobin A1c in blood and low concentrations of albumin in urine
(microalbuminaria), creatinine in urine, and the albumin/creatinine ratio in urine.
The DCA Vantage system is intended for professional use in a physician’s office or hospital
laboratory. Tests performed using the DCA Vantage system are intended for in vitro
diagnostic use. As with all diagnostic tests, do not base a definitive diagnosis on the results of
a single test. A physician should make a diagnosis after all clinical and laboratory findings
are evaluated.

Figure 1-1 DCA Vantage system

The system is a reflectance spectrophotometer that analyzes the color and intensity of the
light reflected through the cartridge optical window and reports the results in clinically
meaningful units. No calculations are required by the user. When an operator swipes a
calibration card, the barcode reader reads the card and the system automatically performs the
calibration.
1-2 Overview

Hardware Overview

User Interface
By default, interaction with the DCA Vantage system is via an integrated touchscreen.
Messages, options, and requests for information display, and responses are made by selecting
the appropriate key symbol on the screen.

CAUTION: Do not use anything hard or pointed on the touchscreen. It may damage
the screen.

You can also use a handheld barcode reader to interact with the system.
The DCA Vantage system is divided into the following 3 modules:
• Test Sequences
• Recall
• System

Testing and Printing Areas

All testing takes place at the DCA Vantage system.
The DCA Vantage system consists of 4 functional areas: the reagent cartridge compartment,
the onboard barcode reader, the display screen, and the printer.
Overview 1-3

The barcode reader is used to calibrate the system and scan the reagent cartridges and control
cards. The reagent cartridges are placed in the reagent cartridge compartment where the tests
are run, and when testing is complete, an internal thermal printer prints the test results.

Figure 1-2 User Interface, Testing, and Printing Areas

1 Onboard Barcode Reader

2 Printer

3 Display Screen

4 Reagent Cartridge Compartment

Connections and Power

The power cord is connected into the power cord receptacle. Turn the system on by pressing
the power switch to the on position. You can connect a USB Flash memory drive, a printer,
an ethernet device, and a handheld barcode to the system using the interface connectors.

Memory
The operating system, the system software, the test data, and the system settings for the DCA
Vantage system are stored in an onboard (non-removable) flash memory. You can insert a
USB Flash memory drive into the system’s USB port during the Backup sequence. You can
then insert the USB memory drive into another DCA Vantage system and restore the data to
the new system.
You can transfer patient data from one DCA Vantage system to another using the software
backup and restore sequences in system settings, refer to System Configuration on page 9.
1-4 Overview

You cannot import data from a spreadsheet into a DCA Vantage system.

Figure 1-3 Power Connection, Power Switch, and Connections

1 Connections

2 Power Switch

3 Power Cord

Software Overview
The DCA Vantage system provides an easy-to-navigate and intuitive user interface. When
the system is not in use for more than 30 minutes, the Power Save Mode automatically turns
on. Touch any ___location on the screen to resume operation.

Screen Components
The DCA Vantage system software screens use a consistent layout.

Figure 1-4 Screen Components

1 Screen Title
Overview 1-5

2 Module Icon and Title

3 Time and Date

4 Title Bar

5 Content Area

6 Navigation and Contextual Help Button Area

Some options require that you enter information. If selected, a numeric keypad or an
alphanumeric keypad displays. An onboard barcode scanner is included and reads only
barcodes of DCA cartridges and calibration cards.
The DCA Vantage system does not support the connection of an external computer keyboard
or a mouse to enter data.
1-6 Overview
Spare parts 2-1

This section will provide pictures and part numbers for the spare part available for the DCA
Vantage instrument

Figure Description Page

1 Upper Case 2-2
2 Middle Case Assembly 2-3
3 Motor Mount Assembly 2-4
4 Optic Assembly 2-5
5 Lower Case Assembly 2-6
6 Display Inverter Assembly 2-7
Misc. Items 2-8
Spare parts 2-2

3
1

Figure 1

Find
Description BAN
Number
1 Reagent compartment Door 06498697
Top Housing molding with window
2 06498700
Note – This is only available as special order
3 Printer Cover 06498689
Spare parts 2-3

4
2

Figure 2

Find
Description BAN
Number
1 Graphical Display with Touchscreen 06498549
2 Door Switch Assembly 06498719
3 Barcode Readhead 06498573
4 DCA Main PCB assembly with bracket 06498522
5 Display Cable 06498557
6 Printer 06498565
Spare parts 2-4

2
5

Figure 3

Find
Description BAN
Number
1 Motor Assembly 06498581
2 Cartridge Holder Assembly 06498654
3 Optical Switch – Home Sensor 06498603
4 Locking Yoke 06498611
5 Preamp Assembly 06498670
Spare parts 2-5

Figure 4

Find
Description BAN
Number
1 Source Optics Assembly Complete 06498638
2 Lamp 06498646
3 Filter - Optical 06498662
Spare parts 2-6

7
2

4
5 Figure 5

Find
Description BAN
Number
1 Pad Rubber with adhesive 06498395
2 Cover Printer Paper 06498379
3 Fan 06498409
4 Speaker 06498983
5 Wire Harness DC Power 06498441
6 Power Supply Assembly 06498433
Fuse (not shown in figure 2 - required) 06498506
7 Fan Filter Bezel 06498417
8 Filter Material 06498425
Spare parts 2-7

Figure 5

Find
Description BAN
Number
1 DCA Assembly Inverter PCB 06498530
Spare parts 2-8

The following items are not shown in any figures in this section.

Description BAN
Cord Set UK – 3 Pin 5 Amp Plug 06498298
USA Cord Set 115 Volt 06498301
Cord Set Europe Moulded Plug 06498352
Printer Paper (5 pack) 06498379
Printer Paper Self Adhesive Stock (pack of 5) 06352780
Optical Test Cartridge 06489221
DCA Cleaning Kit (10) 06488209
Barcode Scanner Kit 06502880
Bar Code Scanner Cable 06498247
Bar Code Scanner Stand 06761052
Collimating Tube (Pak of 2) 06498360
Replacement 3-1

3 Replacement Section
In this section step by step procedures will be provided for the replacement of the serviceable
items in the DCA Vantage instrument.

3 Replacement Section............................................................................................................ 3-1

3.1 Upper Case Disassembly / Assembly .......................................................................... 3-2
3.2 Middle Case Disassembly / Assembly......................................................................... 3-4
3.3 Power Supply Disassembly / Assembly ...................................................................... 3-6
3.4 Power Inverter PCB Disassembly / Assembly............................................................. 3-8
3.5 Display Disassembly / Assembly................................................................................. 3-9
3.6 Printer Disassembly / Assembly ................................................................................ 3-10
3.7 Barcode reader assembly ........................................................................................... 3-11
3.8 Main PCB Disassembly / Assembly .......................................................................... 3-12
3.9 Motor Mount Disassembly / Assembly ..................................................................... 3-13
3.10 Lamp and Optics Disassembly / Assembly ............................................................... 3-14
3.11 Pre amp Disassembly / Assembly.............................................................................. 3-15
3.12 Cartridge Holder Disassembly / Assembly................................................................ 3-17
Replacement 3-2

3.1 Upper Case Disassembly / Assembly

3.1.1 Tool required
Number 2 cross head + screw driver

3.1.2 Disassembly Procedure

1. Shut down the instrument by selecting the power down key from the home menu, wait
until the screen displays “shut down complete – Turn off power”. Then switch power
off. Remove the line cord from the back of the instrument.
2. Turn the instrument upside down so that is resting on its upper case.
3. Remove the two “A” screws identified in figure 3-1.
4. Return instrument to normal upright position. Open the printer cover and remove screw
“B” identified in figure 3-1.
5. The upper case cover can now be removed.

3.1.3 Assembly Procedure

1. Engage the plastic fingers at the bottom of the upper case into the mating slots on the
lower edge of the middle case.
2. Seat the top edge of the upper case onto the middle case.
3. Reinstall screw “B” shown in figure 3-1.
4. Turn the instrument upside down so that it rests on the upper case.
5. Install the two screws “A” shown in figure 3-1.
Replacement 3-3

A B
C

Figure 3-1
Replacement 3-4

3.2 Middle Case Disassembly / Assembly

3.2.1 Tool required
Number 2 cross head screw driver

3.2.2 Disassembly Procedure

1. Remove the Upper case (refer to section 3.1.2).
2. Remove the two screws identified in figure 3-1 as “C”.
3. Remove the two screws identified as "A" figure 3-2. Then lift the reagent compartment
cover up and to the left to gain access and remove the connector identified as “B” in
figure 3-2.
4. Remove the three screws identified as “C, D and E” in figure 3-2.

B
C
D A
Figure 3-2

5. Referring to figure 3-3; lift up the plastic shield and remove heater cable screw “A”,
motor cable connector “B”.
6. Again referring to figure 3-3 disconnect; heater cable from connector “C”, home sensor
cable connector “D”, lamp leads from screw terminals “E” and preamp cable from the
zero insert force (ZIF) locking connector “F”. The motor assembly is now completely
disconnected from the main PCB.
7. The middle case can now be lifted up and laid to the left of the lower case, see figure 3-4.
8. Wire harness, “F” in figure 3-4 connects the middle case to the lower case assembly.
Disconnecting connectors identified in figure 3-4 as: A, B, C and E will free the middle
case from wire harness “F”.
Replacement 3-5

B D

Figure 3-3 G

A B C

D E

Figure 3-4
Replacement 3-6

3.2.3 Assembly Procedure

1. Reconnect the wire harness “F” in figure 3-4.
2. Place the middle case assembly back on to the lower case assembly. It will be necessary
to guide and route the wires and cables from the motor mount assembly back into
position to prevent them from being caught between the cases.
3. Referring to figure 3-3, reconnect the cables in the following order:
a. Preamp cable to connector “F”
b. Lamp leads to connector “E”
c. Home sensor cable to connector “D”
d. Heater cable to connector “C”
e. Motor cable to connector “B”
4. Reinstall the screw “A” that secures and grounds the heater cable to the main PCB.
5. Reinstall screws “C”, “D” and “E” in figure 3-2.
6. Reinstall the two screws “C” shown in figure 3-1.
7. Reinstall the upper case (refer to section 3.1.3)

3.3 Power Supply Disassembly / Assembly

3.3.1 Tool required
Number 2 cross head screw driver

3.3.2 Disassembly Procedure

1. Remove upper case (refer to section 3.1.2)
2. Remove middle case (refer to section 3.2.2)
3. Remove fan cable from cable clip “A” in figure 3-5.
4. Referring to figure 3-5 remove screws “B” and “C”.
5. Lift the hinged section of the power supply bracket up and to the left as indicated by the
red curved arrow in figure 3-5. This will provide full access to screw “D” which should
be removed.
Replacement 3-7

Figure 3-5 D

6. Referring to figure 3-6, loosen screws “A” and “B”.

7. Notice that the holes in the bottom case of the power supply assembly are elongated.
Slide the assembly towards the front of the instrument and lift it out.

Figure 3-6

3.3.3 Assembly Procedure

1. Remove the screws and washer that held the power supply in the lower case. This is
done so that the power supply does not sit on the washed when it is reinstalled.
Replacement 3-8

2. Reinstall the power supply on to the guides “C” in figure 3-6.

3. Slide the power supply toward the back of he instrument so that the power input
assembly seats in the opening for it in the back of the case.
4. Reinstall the screws and washes removed in step 2 to secure the power supply in place,
figure 3-6 “A” and “B”.
5. Reinstall the power supply covers and secure in place with screws “B”, “C”, and “D” in
figure 3-5.
6. Secure the fan cable in the wire clip “A” in figure 3-5.
7. Reinstall the middle case (refer to section 3.2.3).
8. Reinstall the upper case (refer to section 3.1.3).

3.4 Power Inverter PCB Disassembly / Assembly

3.4.1 Tool required
Number 2 cross head screw driver

3.4.2 Disassembly Procedure

1. Remove upper case (refer to section 3.1.2).
2. Remove middle case (refer to section 3.2.2).
3. Referring to figure 3-7, disconnect the input and output cables from connectors “A” and
“B”.
4. Remove screws “C” and “D”. These screws held the Display power inverter PCB to the
middle case assembly.

B
A C D

Figure 3-7

3.4.3 Assembly Procedure

1. Install the inverter PCB to back of the middle case as shown in figure 3-7 using Screw
“C” and “D” to secure.
Replacement 3-9

2. Reconnect the display back light cable to connector “A”.

3. Reconnect the power input cable to connector “B”.
4. Reinstall the middle case (refer to section 3.2.3).
5. Reinstall the upper case (refer to section 3.1.3).

3.5 Display Disassembly / Assembly

3.5.1 Tool required
Number 2 cross head screw driver

3.5.2 Disassembly Procedure

1. Remove the upper case (refer to section 3.1.2)
2. Remove the middle case assembly (refer to section 3.2.2).
3. Referring to figure 3-7 remove the back light cable from connector “A”.
4. Referring to figure 3-8 disconnect the touch screen cable “A” and the display data cable
“B”.
5. Remove the four screws “C”, “D”, “E” and “F” that hold the display assembly to the
middle case assembly.

C D

A B

E
F Figure 3-8

6. Reinstall the four screws “C”, “D”, “E” and “F” in figure 3-8 that hold the display
assembly to the middle case assembly.
7. Referring to figure 3-8 reconnect the touch screen cable “A” and display data cable “B”
8. Guide the display backlight cable through the middle case.
9. Reconnect the display back light cable to connector “A” in figure 3-7 on the power
inverter PCB
Replacement 3-10

10. Reinstall the middle case (refer to section 3.2.3).

11. Reinstall the upper case (refer to section 3.1.3).

3.6 Printer Disassembly / Assembly

3.6.1 Tool required
Number 2 cross head screw driver

3.6.2 Procedure
1. Remove the upper case (refer to section 3.1.2).
2. Referring to figure 3-9, disconnect ribbon cables “A” and “B”.
3. Remove screw “C” which holds the printer to the case.
4. To remove the printer slide it towards the main PCB this will disengage the plastic
fingers “D” and allow the printer to be lifted out.

B
A
C

Figure 3-9

3.6.3 Assembly Procedure

1. Install the printer on the case and slide the edge plastic fingers “D” figure 3-9.
2. Install screw “C” and tighten.
3. Reconnect printer cables “A” and “B”.
4. Reinstall the upper case (refer to section 3.1.3).
Replacement 3-11

3.7 Barcode reader assembly

3.7.1 Tools
Number 2 cross head screw driver

3.7.2 Procedure:
1. Remove the upper case (refer to section 3.1.2).
2. Referring to figure 3-10, the barcode readhead “A” is connected to the main PCB by a
cable “C” and two screws “B”.

A
C
D
B

Figure 3-10

3.7.3 Assembly Procedure

1. Install the barcode readhead on to the two stand-offs “D” in figure 3-10 securing with
two screws “B”.
2. Reconnect the barcode readhead cable into connector “C” on the main PCB.
3. Reinstall the upper case (refer to section 3.1.3).
Replacement 3-12

3.8 Main PCB Disassembly / Assembly

3.8.1 Tools required
Number 2 cross head screw driver

3.8.2 Disassembly Procedure

1. Remove the upper case (refer to section 3.1.2).
2. Remove the middle case (refer to section 3.2.2).
3. Remove the display assembly (refer to section 3.5.2).
4. Referring to figure 3-9 disconnect the printer cables “A” and “B”.
5. The PCB is mounted on an aluminum bracket which is then mounted on the middle case.
The assembly of the PCB and bracket are removed from the middle case by removing the
screws identified as “A” in figure 3-11.

A
A

A
B
B

Figure 3-11
A

3.8.3 Assembly Procedure

1. Install the main PCB and bracket to the middle case and secure in place using screws at
“A” locations in figure 3-11.
2. Referring to figure 3-9 reinstall printer cables “A” and “B”.
3. Reinstall the display assembly (refer to section 3.5.3).
4. Reinstall the middle case (refer to section 3.2.3)
5. Reinstall the upper case (refer to section 3.1.3)
Replacement 3-13

3.9 Motor Mount Disassembly / Assembly

3.9.1 Tools required
Number 2 cross head screw driver

3.9.2 Disassembly Procedure

1. Remove the upper case (refer to section 3.1.2).
2. Remove the middle case (refer to section 3.2.2).
3. Remove the four screws that secure the motor assembly to the lower case, refer to figure
3-12. Two screws “A” are located on the front side of the motor mount assembly and
two screws “B” are located on the rear of the motor mount assembly.

B
Rear Screws

C
A
Front Screws

Figure 3-12

3.9.3 Assembly Procedure

1. Reinstall the motor mount assembly on to the lower case. Secure in place with front
screws “A” and rear screws “B”.
2. Reinstall the middle case (refer to section 3.2.3). Make sure that the sensor and lamp
wires do not get pinched by the middle case at ___location “C” in figure 3-12.
3. Reinstall upper case (refer to section 3.1.3).
Replacement 3-14

3.10 Lamp and Optics Disassembly / Assembly

3.10.1 Tools required

Number 2 cross head screw driver
5/64 hex wrench

3.10.2 Disassembly Procedure

1. Remove the upper case (refer to section 3.1.2).
2. Remove the middle case (refer to section 3.2.2).
3. Remove the motor mount (refer to section 3.9.2).
4. Remove screw identified as “A” in figure 3-13. This will permit the optical assembly to
be removed from the motor mount assembly.

A
C
Figure 3-13

5. To remove the lamp loosen screw “B”, this will permit the lamp to be removed from the
optics assembly.

3.10.3 Assembly Procedure

1. Install the new lamp so that the flat on the base is orientated “UP” as shown by “C” in
figure 3-13. Tighten screw “B” to secure the lamp in place.
Replacement 3-15

2. Reinstall the optics assembly into the Motor mount assembly. Refer to figure 3-14 “A”
for optical filter orientation, the “Gold” colored side of the filter should face out. The
other side of the filter rests against two foam washes “B” on the optics housing. When
installing the assembly the optical filter will be aligned in the Motor assembly by three
guides “C”.
3. Once the optical assembly is in place in the Motor mount assembly secure in place using
the screw “A” in figure 3-13.
4. Reinstall the motor mount assembly (refer to section 3.9.3).
5. Reinstall the middle case (refer to section 3.2.3).
6. Reinstall the upper case (refer to section 3.1.3).

A
B
Figure 3-14

3.11 Pre amp Disassembly / Assembly

3.11.1 Tools required

Number 2 cross head screw driver

3.11.2 Disassembly Procedure

1. Remove the upper case (refer to section 3.1.2)
2. Remove the middle case (refer to section 3.2.2).
3. Remove the motor mount assembly (refer to section 3.9.2).
4. Remove screws “A” and “B” shown in figure 3-15. When screw “A” is removed the
copper grounding spring “C” will come free. This grounding spring is use to make
contact with the conductive copper paint inside the motor mount preamp recess.
5. The preamp assembly flex cable is adhered to the motor mount assembly using a small
piece of double sided adhesive in the area shown by “E”. Carefully peel the cable from
the motor mount.
Replacement 3-16

6. With the preamp PCB assembly removed the collimating tubes “D” can be accessed and
should be blown out with clean air to clear the tubes of dust before the preamp PCB is
reinstalled.

A
C

Figure 3-15

3.11.3 Assembly procedure

1. Blow out the collimating tubes “D” in figure with “clean air” such as canned air for lens
cleaning.
2. Install the preamp PCB assembly into the motor mount, secure in place with screw “B”.
3. Install the copper grounding spring “C” as shown in figure 3-15 and secure the spring and
preamp PCB in place with screw “A”.
4. Press the preamp PCB flex cable onto the adhesive in area “E” of figure 3-15.
5. Reinstall the motor mount assembly (refer to section 3.9.3).
6. Reinstall the middle case (refer to section 3.2.3).
7. Reinstall the upper case (refer to section 3.1.3).
Replacement 3-17

3.12 Cartridge Holder Disassembly / Assembly

3.12.1 Tools
T8x40 Torx drivers
Number 2 standard blade screwdriver
Number 2 cross head screw driver

3.12.2 Disassembly Procedure

1. Remove upper case (refer to section 3.1.2).
2. Remove middle case (refer to section 3.2.2).
3. Remove motor mount assembly (refer to section 3.9.2).
4. Refer to figure 3-16 and rotate the cartridge holder to get access to the set screw “A”.
5. Using a Torx drive, loosen the set screw as shown in “B”.
6. Remove the four screws “C” that hold the motor on to the assembly.
7. Remove the motor shaft from the cartridge holder assembly.

C
C

C C
B

Figure 3-16
Replacement 3-18

3.12.3 Assembly Procedure

1. Using figure 3-17 inspect to make sure that cartridge holder lock spring “B” and the
cartridge holder lock “D” are assembled correctly. The cartridge holder lock has a key
“C” that rests on the spring.
2. Re assembly the cartridge holder assembly with the motor. Align the flat on the cartridge
holder hub figure 3-18 “A” with the flat on the motor shaft, refer to figure 3-18 “B”.
Install the four screws that hold the motor in place, refer to figure 3-16 items “C”.
3. Position the cartridge holder assembly so that its encoding flags are aligned as shown in
figure 3-18 item C so that about 75% of the flag passes thru the optical home sensor (The
optical home sensor is item “E” in figure 3-17). Then secure the cartridge holder
assembly on the motor shaft using the Torx drive to tighten the set screw.
4. Reinstall the motor mount assembly (refer to section 3.9.3).
5. Reinstall the middle case (refer to section 3.2.3).
6. Reinstall the upper case (refer to section 3.1.3).

Figure 3-17
Replacement 3-19

Figure 3-18
Troubleshooting 5-1

5 Troubleshooting

General Information
If an operational or system problem occurs, an error code may display on the system screen
with an explanation of the problem. This section of the guide lists the various errors and
messages, along with a description and corrective actions. If the problem persists, record the
error code and contact your local technical service provider for assistance.
If you think DCA cartridges are causing the problem, consult the product insert that comes
with the cartridges for troubleshooting information.
If you turn the system off, you must retest all samples that were in process when the error
occurred.
With some errors, the system continues to run while the error displays.

CAUTION: Wait at least 15 minutes after the reagent cartridge is removed from the
refrigerator to start a test.

CAUTION: Verify that the capillary is completely filled with no air bubbles.
Troubleshooting 5-2

Corrective
Error or When Corrective action
Description Probable Cause action
Message Detected Service
Customer
Door Open Error The door was open Any sample test door opened or failed Close door 1) Check door sensor
during a test (HbA1c, door sensor rerun test and verify cable is
Microalbumin/Creati connected.
nine) or Optical 2) Replace door sensor.
Filter Test (S1, S2 3) Replace Main PCB
or S3), or during
Motor Homing
operation.

E99 – Internal This is a "catch all" Any time Software or Hardware Call Service Check hardware and
System Error error for internal Bug notify Global Service
system failures and Support
that should never
happen. If this
error is posted, it
usually indicates a
bug in the system.
E3 The DCA analyzer The DCA analyzer The memory device 1) Insert the 1) USB Device
is unable to access is unable to access was disconnected or same USB not seated correctly
the memory device the memory device malfunctioned before memory remove and reseat.
containing a containing a the software update device that 2) Defective
software update software update was completed. was used for USB memory device.
(usually a USB (usually a USB flash the update 3) Defective
flash drive). drive). and press PCB Replace.
"OK" in the
dialog box that
is displaying
the "E3" error.
The system
will then
reboot itself.
2) Customer
contacts
Service
E10 Motor The Home/Index During the Motor Failure of Home/Index Re boot 1) Re-boot instrument
position sensor sensor failed to Homing operation sensor, Sensor circuit, instrument 2) Test optical sensor
error detect light-to-dark following power-up motor, or motor drive using hardware tests.
or dark-to-light or during the Motor circuit; or obstruction Contact 3) Check sensor
transitions during a Homing operation to cartridge holder Service alignment.
Motor Homing performed when a rotation 4) Blow out sensor
operation. OR The test is aborted. possible dust
offset between the 5) Sensor bad
Home position Replace
determined from 6) PCB failure replace
the Home/Index PCB
senor and the
position for the
optimum optical
signal is greater
than +/- 4 half-
steps.

E12 Motor The wrong number During any motor Failure of Home/Index Re-boot 1) Re-boot instrument
Position error of Home/Index rotation that occurs sensor, Sensor circuit, instrument 2) Test optical sensor
sensor transitions during a sample motor, or motor drive using hardware tests.
were detected test, optics test, or circuit; or obstruction Contact 3) Check sensor
during a motor Motor position test to cartridge holder service alignment.
rotation operation. in service. rotation 4) Blow out sensor
possible dust
5) Sensor bad
Replace.
6) PCB failure replace
PCB
Troubleshooting 5-3

Corrective
Error or When Corrective action
Description Probable Cause action
Message Detected Service
Customer
E20 Dark offset A "Dark" reading During any sample Electronic failure Contact 1) Check that Preamp
measurement out (mean of 16) for test (HbA1c, service connector is correctly
of range sample or Microalbumin/Creati seated.
reference channel nine), or Optical 2) Possible pre-amp
is outside the Test (S1, S2, or S3). PCB failure, replace
acceptance range. PCB
(see 4.2.3.1) 3) Possible main PCB
failure, replace main
PCB
E21 Lamp failure An "Air" reading During Power On Incorrect position of 1) Re-boot 1) Blow out cartridge
(mean of 16) for Initialization or any cartridge holder; or instrument. area.
sample or sample test (HbA1c, failure of lamp, lamp 2) Clean 2) Verify cartridge
reference channel Microalbumin/Creati drive circuit, cartridge holder in correct
is too low. (see nine), Optical Filter photodiode/preamp holder area, ___location.
4.2.3.1) Test (S1, S2 or S3). circuit, or analog data dust blocking 3) Check for lamp
acquisition reference function. If not
electronics. channel light functional confirm
path. (use voltage. If voltage ok
compressed replace lamp, if voltage
air) not present replace
Main PCB.
4) If lamp functional
clean optics and
collimation tubes
E22 Optical A Sample or During Power On Failure of 1) Re-boot 1) Blow out cartridge
Reading Out of Reference channel initialization or any photodiode/preamp instrument. area.
Range reading (mean of sample test (HbA1c, detector circuit, lamp 2) Clean 2) Verify cartridge
16) taken during Microalbumin/Creati drive circuit or optical cartridge holder in correct
an Air nine), Optical Filter system holder area, ___location.
measurement is Test (S1, S2, or S3). dust blocking 3) Check for lamp
too high (greater reference function. If not
than the reliable channel light functional confirm
measurement path. (use voltage. If voltage ok
range). (see compressed replace lamp, if voltage
4.2.3.1) air) not present replace
Main PCB.
4) If lamp functional
clean and / or replace
optics and collimation
tubes
5) Replace Pre Amp
PCB
E23 Excessive The standard During Power On Low lamp intensity, or 1) Re-boot 1) Blow out cartridge
Noise in Sample deviation of the 16 Initialization, any lamp instrument. area.
Channel Reading readings on the sample test, or any alignment/rotation, or 2) Clean 2) Verify cartridge
Sample channel optical test lamp intensity cartridge holder in correct
for Dark or Air variation, or electronic holder area, ___location.
reading is too defect dust blocking Check for lamp function.
large. (NOTE: reference 3) If not functional
This test cannot be channel light confirm voltage. If
performed until the path. (use voltage ok replace lamp,
first air compressed if voltage not present
measurement is air) replace Main PCB.
taken.) (see 4) If lamp functional
4.2.3.2) clean and / or replace
optics and collimation
tubes
5) Replace Preamp
PCB
E24 Excessive The standard During Power On Low lamp intensity, or 1) Re-boot 1) Blow out cartridge
Noise in deviation of the 16 Initialization or any lamp instrument. area.
Reference readings on the sample test (HbA1c, alignment/rotation, or 2) Clean 2) Verify cartridge
Channel Reading Reference channel Microalbumin/Creati variation in lamp cartridge holder in correct
for Dark, Air, or nine), Optical Filter intensity, or electronic holder area, ___location.
Sample reading is Test (S1, S2 or S3). defect dust blocking 3) Check for lamp
Troubleshooting 5-4

Corrective
Error or When Corrective action
Description Probable Cause action
Message Detected Service
Customer
too large. (NOTE: reference function.
This test cannot be channel light 4) If not functional
performed until the path. (use confirm voltage. If
first air compressed voltage ok replace lamp,
measurement is air) if voltage not present
taken.) (see replace Main PCB.
4.2.3.2) 5) If lamp functional
clean and / or replace
optics and collimation
tubes
6) Replace Preamp
PCB
E26 Excessive The standard Any sample test Low lamp intensity, or 1) Re-boot 1) Blow out cartridge
Noise in Sample deviation of the 16 (HbA1c, lamp instrument. area.
Channel During readings on the Microalbumin/Creati alignment/rotation, or 2) Clean 2) Verify cartridge
Sample Reading Sample channel nine) or Optical lamp intensity cartridge holder in correct
during Filter Test (S1, S2 variation, or holder area, ___location.
a reading taken in or S3). electronic defect dust blocking 3) Check for lamp
Sample read reference function.
position. (NOTE: channel light 4) If not functional
This test cannot be path. (use confirm voltage. If
performed until the compressed voltage ok replace lamp,
first air air) if voltage not present
measurement is replace Main PCB.
taken.)(see 5) If lamp functional
4.2.3.2) clean and / or replace
optics and collimation
tubes
6) Replace Preamp
PCB
E27 Excessive The change in During any sample Dust contamination in 1) Re-boot 1) Blow out cartridge
Lamp Drift mean signal test (HbA1c, the optical path, or instrument. area.
between Microalbumin/Creati lamp filament 2) Clean 2) Verify cartridge
successive Air nine), or Optical orientation, or lamp cartridge holder in correct
readings is too Filter Test (S1, S2 variation, or electronic holder area, ___location.
large on either the or S3). defect. dust blocking 3) Check for lamp
Sample channel or reference function.
the Reference channel light 4) If not functional
channel. (NOTE: path. (use confirm voltage. If
This test cannot be compressed voltage ok replace lamp,
performed until the air) if voltage not present
second air replace Main PCB.
measurement is 5) If lamp functional
taken.) (see clean and / or replace
4.2.3.3) optics and collimation
tubes
6) Replace Preamp
PCB
E30 Cartridge The temperature Continuously during Major defect in heater 1) Re-boot 1) Check to make
Temperature measured by one system idle time and plate/thermistor instrument. sure that heater cable is
Extremely Low of the cartridge during Sample tests. assembly, connector, fully inserted into the
holder thermistors or electrical circuit; or Main PCB
is <= 2ºC. ambient temperature 2) Replace the
<4ºC (far out of Cartridge heater
operating range) assembly.
3) Replace the Main
PCB.
E31 Cartridge The temperature Continuously while Cold cartridge; or 1) Make 1) Check to make
Temperature Out measured by one the system is idle failed heater sure that sure that heater cable is
of Range Low of the cartridge and during Optical plate/thermistor reagent fully inserted into the
holder thermistors Test. Also during assembly, connector cartridge Main PCB
is <= (Tsetpoint - sample tests as or electrical circuit handling 2) Replace the
12.9)ºC while the follows .HbA1c: procedures in Cartridge heater
system is idle, or from the start of the reagent assembly.
during an Optical test until 3 minutes product insert 3) Replace the Main
Troubleshooting 5-5

Corrective
Error or When Corrective action
Description Probable Cause action
Message Detected Service
Customer
Test, the first 3 after the start have been PCB.
minutes of an Microalbumin followed.
HbA1c test, or the /Creatinine: from the 2) Reboot
first 5 minutes or a start of the test until system and
Microalbumin/ 5 minutes after the repeat test.
Creatinine test. start

E32 Cartridge The temperature HbA1c: 3 minutes Cold cartridge; or 1) Make 1) Check to make
Temperature measured by one after start of test failed heater sure that sure that heater cable is
Below Limit of the cartridge until the end plate/thermistor reagent fully inserted into the
During Critical holder thermistors Microalbumin / assembly, connector cartridge Main PCB
Measurement is <= (Tsetpoint - Creatinine: 5 or electrical circuit handling 2) Replace the
0.9)ºC during minutes after start of procedures in Cartridge heater
critical test until the end reagent assembly.
measurements of a product insert 3) Replace the Main
sample test have been PCB.
sequence. followed.
2) Reboot
system and
repeat test.
E33 Cartridge The temperature HbA1c: 3 minutes Cold cartridge; or 1) Reboot 1) Check to make
Temperature measured by one after start of test failed heater system and sure that heater cable is
Above Limit of the cartridge until the end plate/thermistor repeat test. fully inserted into the
During Critical holder thermistors assembly, connector Main PCB
Measurement is >= (Tsetpoint + Microalbu or electrical circuit 2) Replace the
1.1)ºC during min / Creatinine: 5 Cartridge heater
critical minutes after start of assembly.
Measurements of a test until 3) Replace the Main
sample test PCB.
sequence. the end

E34 Cartridge The temperature Continuously while Cold cartridge; or 1) Reboot 1) Check to make
Temperature Out measured by one the system is idle failed heater system and sure that heater cable is
of Range High of the cartridge and during Optical plate/thermistor repeat test. fully inserted into the
holder thermistors Test. Also during assembly, connector Main PCB
is >= (Tsetpoint + sample tests as or electrical circuit 2) Replace the
2.1)ºC follows..HbA1c: Cartridge heater
from the start of the assembly.
test until 3 minutes 3) Replace the Main
after the start PCB.
Microalbumin
/Creatinine: from the
start of the test until
5 minutes after the
start
E35 Cartridge The temperature Continuously during Major defect in heater 1) Reboot 1) Check to make
Temperature measured by one system idle time and plate/thermistor system and sure that heater cable is
Extremely High of the cartridge during Sample tests. assembly, connector, repeat test. fully inserted into the
holder thermistors or electrical circuit; Main PCB
is >= 50ºC. ambient temperature 2) Replace the
too high (far out of Cartridge heater
operating range) assembly.
3) Replace the Main
PCB.
E36 Temperature 10 minutes after Continuously Failure of heater 1) Reboot 1) Check to make
After 10 Minutes power-on, the plate/thermistor system and sure that heater cable is
Still Out of Range cartridge assembly, connector, repeat test. fully inserted into the
temperature has heater driver, or Main PCB
not reached the electronics 2) Replace the
operating range of Cartridge heater
(Tsetpoint - 13.2)ºC < assembly.
T < (Tsetpoint + 3) Replace the Main
1.8)ºC, or the PCB.
cartridge
temperature
Troubleshooting 5-6

Corrective
Error or When Corrective action
Description Probable Cause action
Message Detected Service
Customer
remains outside
the same operating
range
for more than 10
minutes.
E37 Internal The temperature Continuously during Damaged ambient 1) Reboot 1) Reset the ambient
Instrument measured by the system idle time and temperature system and temperature sensor.
Temperature ambient during Sample tests thermistor or circuit repeat test. 2) Replace the Main
Extremely Low temperature failure PCB.
thermistor is <=
2ºC
E38 Internal The temperature Continuously during Damaged ambient 1) Reboot 1) Reset the ambient
Instrument measured by the system idle time and thermistor or circuit system and temperature sensor.
Temperature ambient during Sample tests. failure repeat test. 2) Replace the Main
Extremely High temperature PCB.
thermistor is >=
50ºC
E40 Incorrect The number of Any time a bar code Incorrect bar code; or 1) Rescan 1) Bar code reader
Number of Bar digits read by the is read partial bar code scan; the bar code head dirty clean with air.
Code Digits bar code reader or failure of bar code in different 2) Bar code reader
does not match reader. direction window dirty / scratched
what is expected. 2) Try a replace upper case.
different 3) Bar code reader
barcode head damaged replace
source reader head.
cartridge or 4) Main PCB bad
Calibration replace.
card
3) Bar code
window is dirty
–clean

E41 Incorrect Bar The bar code has Any time a bar code Incorrect bar code 1) Rescan 1) Bar code reader
Code Data the correct number scanning is allowed data or bar code read the bar code head dirty clean with air.
of digits, but the error in different 2) Bar code reader
character does not direction window dirty / scratched
match the 2) Try a replace upper case.
expected pattern different 3) Bar code reader
barcode head damaged replace
source reader head.
cartridge or 4) Main PCB bad
Calibration replace.
card
3) Bar code
window is dirty
–clean

E50 Serial Port An attempt to Any time the Bad/missing 1) Reseat 1) Test serial port
Communication communicate via analyzer attempts to connection or printer cable using loop back
failure the RS232 serial communicate with electronic failure on Vantage connector. Replace
port has failed an external and at main PCB if necessary
computer / LIS destination
2) Check
that the
RS232 serial
port on the
Vantage is
configured to
meet the
requirements
of the host
device.
3) Verify
that serial port
works with a
Troubleshooting 5-7

Corrective
Error or When Corrective action
Description Probable Cause action
Message Detected Service
Customer
loop back
connector or
PC using
hyper
terminal.
4) Return
instrument for
service

E51 Serial Port Communication Whenever the Bad/missing same as 1) Test Ethernet port
Communication has not succeeded analyzer attempts to connection or above Replace main PCB if
Error even after the communicate with electronic failure necessary same as
allowed retries are an external above
exhausted. computer / LIS via
the RS232 Serial
Port and there is
already an E50
error.
E55 Ethernet Port An attempt to Any time the Bad/missing 1) Reseat same as above
Communication communicate via analyzer attempts to connection or Ethernet cable
Failure the Ethernet serial communicate with electronic failure on Vantage
port has failed. and external and at
computer / LIS via destination
the Ethernet port 2) Check
that the
Ethernet port
on the
Vantage is
configured to
meet the
requirements
of the host
device.
3) Return
instrument for
service

E56 Ethernet Port Communication Whenever the Bad/missing same as same as above
Communication has not succeeded analyzer attempts to connection or above
Error even after the communicate with electronic failure
allowed retries are an external
exhausted computer / LIS via
the Ethernet
connection and
there is already a
E55 error
E60 Database The database is During database Corruption of the 1) Re-boot 1) Reboot the system
Failure not functioning - compaction or when database the system 2) Re-initialize
cannot read or opening the database with another
write. database application
E61 Database A database read An error was Corruption of the 1) Re-boot 1) Reboot the system
Read Failure operation has returned from a database the system 2) Re-initialize
failed resulting in database write database with another
no data or operation. application
corrupted data
being returned
D62 Database An error was An error was Corruption of the 1) Re-boot 1) Reboot the system
Write Error returned from a returned from a database the system 2) Re-initialize
database write database write database with another
operation. operation. application
E63 Database The database has Immediately after The database has 1) Delete 1) Reboot the system
Full completely filled its saving the last reached its allotted some records 2) Re-initialize
allotted capacity sample test result limit 2) Re-boot database with another
for storing sample has filled the system application
test results. database.
Troubleshooting 5-8

Corrective
Error or When Corrective action
Description Probable Cause action
Message Detected Service
Customer
E101 HbA1c The mean During HbA1c test No cartridge present; 1) Make 1) Blow out cartridge
Buffer Mean transmittance of sequence or optical problem; or sure cartridge area.
Absorbance Too the 10 buffer electronic drift is fully 2) Verify cartridge
Low readings inserted and holder integrity and
(buf1...buf10) is locked in motor positions cartridge
too high. place. in correct ___location.
2) Review 3) Check for lamp
cartridge function and drift.
handling Replace lamp if
instructions necessary.
3) Inspect 4) If lamp functional
cartridge clean and / or replace
window for optics and collimation
scratches or tubes
finger prints 5) Replace Preamp
4) Run PCB
optical test 6) Replace Main
cartridge. PCB.
5) Clean
cartridge
holder area,
dust blocking
reference
channel light
path. (use
compressed
air)
6) Rerun
test
E102 HbA1c The mean During HbA1c test Condensation on 1) Make 1) Blow out cartridge
Buffer Mean transmittance of sequence cartridge optical sure cartridge area.
Absorbance Too the 10 buffer window; or cartridge is fully 2) Verify cartridge
High readings not located correctly inserted and holder integrity and
(buf1...buf10) is in holder; or defect on locked in motor positions cartridge
too low. optical cartridge place. in correct ___location.
optical window; or 2) Review 3) Check for lamp
buffer tab not pulled; cartridge function and drift.
or cartridge use life handling Replace lamp if
expired; or optical instructions necessary.
problem; or electronic 3) Inspect 4) If lamp functional
drift cartridge clean and / or replace
window for optics and collimation
scratches or tubes
finger prints 5) Replace Preamp
4) Run PCB
optical test 6) Replace Main
cartridge. PCB.
5) Clean
cartridge
holder area,
dust blocking
reference
channel light
path. (use
compressed
air)
6) Rerun
test
E103 Buffer The coefficient of During HbA1c test Condensation of 1) Make 1) Blow out cartridge
Coefficient of variation (%CV) of sequence cartridge optical sure cartridge area.
Variation Too the 10 window; or particulate is fully 2) Verify cartridge
High transmittance contamination in inserted and holder integrity and
readings the buffer cartridge; or cartridge locked in motor positions cartridge
solution in the use life expired; or place. in correct ___location.
reagent cartridge is high "short term" 2) Review 3) Check for lamp
too high. instrument drift cartridge function and drift.
Troubleshooting 5-9

Corrective
Error or When Corrective action
Description Probable Cause action
Message Detected Service
Customer
handling Replace lamp if
instructions necessary.
3) Inspect 4) If lamp functional
cartridge clean and / or replace
window for optics and collimation
scratches or tubes
finger prints 5) Replace Preamp
4) Run PCB
optical test 6) Replace Main
cartridge. PCB.
5) Clean
cartridge
holder area,
dust blocking
reference
channel light
path. (use
compressed
air)
6) Rerun
test
E104 Blood The transmittance During HbA1c test No sample; low total 1) Make 1) Blow out cartridge
Pickup of the blood pickup sequence hemoglobin; or sure cartridge area.
Absorbance Too reading is too high. capillary not is fully 2) Verify cartridge
Low completely filled or inserted and holder integrity and
bubble locked in motor positions cartridge
place. in correct ___location.
2) Review 3) Check for lamp
cartridge function and drift.
handling Replace lamp if
instructions necessary.
and sample 4) If lamp functional
device filling clean and / or replace
procedures. optics and collimation
3) Inspect tubes
cartridge 5) Run performance
window for test.
scratches or
finger prints
4) Rerun
test
E105 Blood The transmittance During HbA1c test Too much blood (drop 1) Make 1) Blow out cartridge
Pickup of the blood pickup sequence of blood on outer sure cartridge area.
Absorbance Too reading is too low. surface of capillary); is fully 2) Verify cartridge
High or total inserted and holder integrity and
hemoglobin too high; locked in motor positions cartridge
or cartridge not place. in correct ___location.
allowed to warm up; 2) Review 3) Check for lamp
blood not lysing; or cartridge function and drift.
cartridge use life handling Replace lamp if
expired; or blood instructions necessary.
sample cell and sample 4) If lamp functional
irregularity or device filling clean and / or replace
abnormal hemoglobin procedures. optics and collimation
3) Inspect tubes
cartridge 5) Run performance
window for test.
scratches or
finger prints
4) Rerun
test
E106 Hemoglobin The mean During HbA1c test Total hemoglobin < 7 1) Make 1) Blow out cartridge
Absorbance Too transmittance of sequence g/dL; or under-filled sure cartridge area.
Low the hemoglobin sample capillary; or is fully 2) Verify cartridge
readings is too bubble in sample inserted and holder integrity and
Troubleshooting 5-10

Corrective
Error or When Corrective action
Description Probable Cause action
Message Detected Service
Customer
high locked in motor positions cartridge
place. in correct ___location.
2) Review 3) Check for lamp
cartridge function and drift.
handling Replace lamp if
instructions necessary.
and sample 4) If lamp functional
device filling clean and / or replace
procedures. optics and collimation
3) Inspect tubes
cartridge 5) Run performance
window for test.
scratches or
finger prints
4) Rerun
test
E107 Hemoglobin The mean During HbA1c test Total hemoglobin > 1) Make 1) Blow out cartridge
Absorbance Too transmittance of sequence 24 g/dL; excess blood sure cartridge area.
High the hemoglobin on sides of is fully 2) Verify cartridge
readings is too low capillary(not wiped inserted and holder integrity and
off); or wicking of locked in motor positions cartridge
blood between the place. in correct ___location.
capillary and capillary 2) Review 3) Check for lamp
holder; or blood not cartridge function and drift.
lysing (cold cartridge); handling Replace lamp if
blood cell irregularity; instructions necessary.
or abnormal and sample 4) If lamp functional
hemoglobin device filling clean and / or replace
procedures. optics and collimation
3) Inspect tubes
cartridge 5)
window for
scratches or
finger prints
4) Rerun
test
E108 %CV of The %CV of the During HbA1c test Particulate 1) Review 1) Blow out cartridge
Hemoglobin transmittance of sequence contamination in cartridge area.
Readings Too the hemoglobin cartridge; or high storage and 2) Verify cartridge
Large readings is too "short term" handling holder integrity and
large. instrument drift instructions. motor positions cartridge
2) Inspect in correct ___location.
cartridge 3) Check for lamp
window for function and drift.
scratches and Replace lamp if
finger prints necessary.
3) Run 4) If lamp functional
optical test clean and / or replace
cartridge. optics and collimation
4) Rerun tubes
test. 5) Run performance
test.
E109 Individual The absorbance of During HbA1c test Cartridge exposed to 1) Review Most likely a reagent
Agglutination one of the sequence excessive cartridge problem
Reading Too Low agglutinations is temperature and/or storage and
too low humidity; or low or no handling
agglutination instructions.
2) Inspect
cartridge
window for
scratches and
finger prints
3) Rerun
test.
E110 Individual The absorbance of During HbA1c test Cartridge exposed to 1) Review Most likely a reagent
Troubleshooting 5-11

Corrective
Error or When Corrective action
Description Probable Cause action
Message Detected Service
Customer
Agglutination one of the sequence excessive cartridge problem
Reading Too High agglutinations is temperature and/or storage and
too high. humidity; or high handling
agglutination instructions.
2) Inspect
cartridge
window for
scratches and
finger prints
3) Rerun
test.
E111 Delta in The delta in During HbA1c test Cartridge exposed to 1) Review Most likely a reagent
Agglutination absorbance sequence excessive cartridge problem
Absorbance Too between the first temperature and/or storage and
Low and last humidity; or low or no handling
agglutination agglutination instructions.
reading is too low. 2) Inspect
cartridge
window for
scratches and
finger prints
3) Rerun
test.
E112 Delta in The delta in During HbA1c test Cartridge exposed to 1) Review Most likely a reagent
Agglutination absorbance sequence excessive cartridge problem
Absorbance Too between the first temperature and/or storage and
High and last humidity handling
agglutination instructions.
reading is too high. 2) Inspect
cartridge
window for
scratches and
finger prints
3) Rerun
test.
E113 Third Order The A1 parameter During HbA1c test Cartridge exposed to 1) Review Most likely a reagent
Polynomial Fit from the third order sequence excessive cartridge problem
Parameter A1 Too polynomial fit is an temperature and/or storage and
Negative unexpectedly large humidity; or handling
negative number. particulate instructions.
contamination in 2) Inspect
cartridge cartridge
window for
scratches and
finger prints
3) Rerun
test.
E114 Third Order The A2 parameter During HbA1c test Cartridge exposed to 1) Review Most likely a reagent
Polynomial Fit from the third order sequence excessive cartridge problem
Parameter A2 Too polynomial fit is too temperature and/or storage and
Large large. humidity; or handling
particulate instructions.
contamination in 2) Inspect
cartridge cartridge
window for
scratches and
finger prints
3) Rerun
test.
E115 Large The difference During HbA1c test Cartridge exposed to 1) Review Most likely a reagent
Change in between the blood sequence excessive cartridge problem
Hemoglobin pickup absorbance temperature and/or storage and
Absorbance and the mean humidity; or handling
Reading hemoglobin particulate instructions.
absorbance is too contamination in 2) Inspect
Troubleshooting 5-12

Corrective
Error or When Corrective action
Description Probable Cause action
Message Detected Service
Customer
large. cartridge cartridge
window for
scratches and
finger prints
3) Rerun
test.
E116 Mean The Mean Squared During HbA1c test Cartridge defect; or 1) Review Most likely a reagent
Squared Error of Error calculated sequence high sample cartridge problem
Agglutination after the third order absorbance storage and
Readings Too polynomial fit of handling
Large the agglutination instructions.
readings is too 2) Inspect
large. cartridge
window for
scratches and
finger prints
3) Rerun
test.
E301 The mean During No cartridge present; 1) Make 1) Blow out cartridge
Microalbumin / transmittance of Microalbumin / or optical problem; sure cartridge area.
Creatinine Buffer the 10 buffer Creatinine test electronic drift is fully 2) Verify cartridge
Mean Absorbance readings sequence inserted and holder integrity and
Too Low (buf1...buf10) is locked in motor positions cartridge
too high. place. in correct ___location.
2) Review 3) Check for lamp
cartridge function and drift.
handling Replace lamp if
instructions necessary.
3) Inspect 4) Run performance
cartridge test.
window for
scratches or
finger prints
4) Run
optical test
cartridge.
5) Clean
cartridge
holder area,
dust blocking
reference
channel light
path. (use
compressed
air)
6) Rerun
test
E302 The mean During Condensation, dirt or 1) Make 1) Blow out cartridge
Microalbumin / transmittance of Microalbumin / defect on cartridge sure cartridge area.
Creatinine Buffer the 10 buffer Creatinine test optical window; buffer is fully 2) Verify cartridge
Mean Absorbance readings sequence tab removed before inserted and holder integrity and
Too High (buf1...buf10) is inserting cartridge; or locked in motor positions cartridge
too low. buffer tab not pulled; place. in correct ___location.
or cartridge not 2) Review 3) Check for lamp
located correctly in cartridge function and drift.
holder; or optical handling Replace lamp if
problem; electronic instructions necessary.
drift 3) Inspect 4) Run performance
cartridge test.
window for
scratches or
finger prints
4) Run
optical test
cartridge.
Troubleshooting 5-13

Corrective
Error or When Corrective action
Description Probable Cause action
Message Detected Service
Customer
5) Clean
cartridge
holder area,
dust blocking
reference
channel light
path. (use
compressed
air)
6) Rerun
test
E303 The coefficient of During Particulate 1) Make 1) Blow out cartridge
Microalbumin / variation (%CV) of Microalbumin / contamination in sure cartridge area.
Creatinine Buffer the 10 Creatinine test cartridge; or capillary is fully 2) Verify cartridge
Coefficient of transmittance sequence tube broken and inserted and holder integrity and
Variation Too readings taken of starch plug in assay locked in motor positions cartridge
High the buffer solution buffer; or high "short place. in correct ___location.
in the reagent term" instrument drift 2) Review 3) Check for lamp
cartridge is too cartridge function and drift.
high. handling Replace lamp if
instructions necessary.
3) Inspect 4) Run performance
cartridge test.
window for
scratches or
finger prints
4) Run
optical test
cartridge.
5) Clean
cartridge
holder area,
dust blocking
light path. (use
compressed
air)
6) Rerun
test
E304 Sample The mean During Particulate 1) Make 1) Blow out cartridge
Blank Mean transmittance of 1 Microalbumin / contamination in sure cartridge area.
Absorbance Too of the 3 sets of Creatinine test cartridge is fully 2) Verify cartridge
Low sample blank sequence inserted and holder integrity and
reading is too high locked in motor positions cartridge
place. in correct ___location.
2) Review 3) Check for lamp
cartridge function and drift.
handling Replace lamp if
instructions necessary.
3) Inspect 4) Run performance
cartridge test.
window for
scratches or
finger prints
4) Run
optical test
cartridge.
5) Clean
cartridge
holder area,
dust blocking
light path. (use
compressed
air)
6) Rerun
test
Troubleshooting 5-14

Corrective
Error or When Corrective action
Description Probable Cause action
Message Detected Service
Customer
E305 Sample The mean During Urine sample is turbid 1) Make 1) Blow out cartridge
Blank Mean transmittance of Microalbumin / or highly colored. sure cartridge area.
Absorbance Too the "low sample Creatinine test is fully 2) Verify cartridge
High blank" is too low. sequence inserted and holder integrity and
locked in motor positions cartridge
place. in correct ___location.
2) Review 3) Check for lamp
cartridge function and drift.
handling Replace lamp if
instructions necessary.
3) Inspect 4) Run performance
cartridge test.
window for
scratches or
finger prints
4) Run
optical test
cartridge.
5) Clean
cartridge
holder area,
dust blocking
light path. (use
compressed
air)
6) Rerun
test
E306 %CV The %CV of the During Particulate 1) Make 1) Blow out cartridge
Sample Blank "low sample blank" Microalbumin / contamination in sure cartridge area.
Too High is too high. Creatinine test cartridge; or cartridge is fully 2) Verify cartridge
sequence use life expired; or inserted and holder integrity and
cartridge exposed to locked in motor positions cartridge
high temperature place. in correct ___location.
and/or humidity; or 2) Review 3) Check for lamp
capillary tube broken cartridge function and drift.
and starch plug in handling Replace lamp if
assay buffer; or high instructions necessary.
"short term" 3) Inspect 4) Run performance
instrument drift cartridge test.
window for
scratches or
finger prints
4) Run
optical test
cartridge.
5) Clean
cartridge
holder area,
dust blocking l
light path. (use
compressed
air)
6) Rerun
test
E307 Mean The mean of the During Cartridge exposed to 1) Make Most likely a reagent
Microalbumin Microalbumin Microalbumin / high temperature sure cartridge issue
Absorbance Too transmittance Creatinine test and/or humidity is fully
Low readings is too sequence inserted and
high locked in
place.
2) Review
cartridge
handling
instructions
3) Inspect
cartridge
Troubleshooting 5-15

Corrective
Error or When Corrective action
Description Probable Cause action
Message Detected Service
Customer
window for
scratches or
finger prints
4) Run
optical test
cartridge.
5) Clean
cartridge
holder area,
dust blocking
light path. (use
compressed
air)
6) Rerun
test
Mean The mean of the During Cartridge exposed to 1) Make Most likely a reagent
Microalbumin Microalbumin Microalbumin / high temperature sure cartridge issue
Absorbance Too transmittance Creatinine test and/or humidity is fully
High readings is too low. sequence inserted and
locked in
place.
2) Review
cartridge
handling
instructions
3) Inspect
cartridge
window for
scratches or
finger prints
4) Run
optical test
cartridge.
5) Clean
cartridge
holder area,
dust blocking
light path. (use
compressed
air)
6) Rerun
test
E309 %CV of The %CV of the During Particulate 1) Make Most likely a reagent
Microalbumin Microalbumin Microalbumin / contamination in sure cartridge issue
Transmittance transmittance Creatinine test cartridge; or high is fully
Too High readings is too sequence "short term" inserted and
high. instrument drift locked in
place.
2) Review
cartridge
handling
instructions
3) Inspect
cartridge
window for
scratches or
finger prints
4) Run
optical test
cartridge.
5) Clean
cartridge
holder area,
dust blocking
light path. (use
compressed
Troubleshooting 5-16

Corrective
Error or When Corrective action
Description Probable Cause action
Message Detected Service
Customer
air)
6) Rerun
test
E310 Creatinine One of 26 During Cartridge exposed to 1) Make Most likely a reagent
Absorbance Too Creatinine Microalbumin / high temperature sure cartridge issue
Low absorbance Creatinine test and/or high humidity is fully
readings is too low. sequence inserted and
locked in
place.
2) Review
cartridge
handling
instructions
3) Inspect
cartridge
window for
scratches or
finger prints
4) Run
optical test
cartridge.
5) Rerun
test
E311 Creatinine One of 26 During Cartridge exposed 1) Make Most likely a reagent
Absorbance Creatinine Microalbumin / to high temperature sure cartridge issue
Too High absorbance Creatinine test and/or high is fully
inserted and
readings is too sequence humidity
locked in
high. place.
2) Review
cartridge
handling
instructions
3) Inspect
cartridge
window for
scratches or
finger prints
4) Run
optical test
cartridge.
5) Rerun
test
E313 Mean The Mean Squared During Particulate 1) Make Most likely a reagent
Squared Error of Error calculated Microalbumin / contamination in sure cartridge issue
Creatinine after the third order Creatinine test cartridge; or capillary is fully
Absorbance Too polynomial fit of sequence tube broken and inserted and
Large the Creatinine starch plug in assay locked in
absorbance buffer; or cartridge place.
readings is too exposed to high 2) Review
large. temperature and/or cartridge
high humidity handling
instructions
3) Inspect
cartridge
window for
scratches or
finger prints
4) Run
optical test
cartridge.
5) Clean
cartridge
holder area,
dust blocking
Troubleshooting 5-17

Corrective
Error or When Corrective action
Description Probable Cause action
Message Detected Service
Customer
reference
channel light
path. (use
compressed
air)
6) Rerun
test
E315 The Microalbumin After scanning a The instrument has 1) Run the 1) Run normalization
Microalbumin Normalization has Microalbumin / not been normalized Normalization cartridge
Normalization Not not been Creatinine test (Optical Filter Test cartridge. 2) Reset system from
Set performed or the cartridge S3); or the MNF has 2) Reboot factory setting mode
Microalbumin been corrupted; or the the instrument 3) Replace main PCB
Normalization computer's database 3) Rerun
Factor (MNF) has has been corrupted test
been corrupted.
E316 The Microalbumin When running the Instrument 1) Clean 1) Run normalization
Microalbumin Normalization Microalbumin normalization cartridge cartridge
Normalization Out Factor being Normalization procedure did not holder area, 2) Reset system from
of Range entered is outside (Optical Filter Test correctly enter the dust blocking factory setting mode
of the expected S3) normalization factor. reference 3) Replace main PCB
range. OR The normalization channel light
cartridge was not path. (use
correctly located in compressed
the cartridge holder. air)
OR The normalization 2) Re-run
scatter filter is the
contaminated, dirty, Normalization
misaligned, or cartridge.
missing. OR Optical 3) Reboot
or electronic the instrument
instrument defect. 4) Return
instrument for
service
E70 Internal The Internal printer When the printing to Bad/missing 1) Return 1) Reseat printer
Printer Error has failed due to a the internal printer connection or instrument for cables in connectors
hardware error electronic failure service 2) Replace printer
3) Replace Main PCB
E71 External The External When attempting to Bad/missing 2) Make 1) Test external
Printer Error printer has failed connect or print to connection or sure printer printer port. Replace
due to a hardware the external printer electronic failure power is on. main PCB if necessary
error 3) Reseat
printer cable
on Vantage
and at printer
4) Turn
printer off then
back on
5) Verify
that external
printer works
using PC.
6) Return
instrument for
service
5-18 Troubleshooting

Customer system tests

The following table includes the customer system tests. For more information on customer
system tests, see Operating the System on page 1.

Test Description
Touchscreen test Tests if the touchscreen is functioning properly.
Internal barcode test Tests if the internal barcode is functioning properly.
Internal printer test Tests if the internal printer is functioning properly.
Serial port test Tests if the serial port is connected properly.
USB port test Tests if the USB port is connected properly.
Lamp test Tests if the lamp is functioning properly.
Door test Tests if the door is opening and closing properly.
External barcode Tests if the external barcode reader is functioning properly.
reader test
External printer test Tests if the external printer is functioning properly.
External port test (if Tests if the external port is functioning properly.
supported)
Motor control test Tests if the motor control is functioning properly.
Measurement system Tests if the measurement are working properly.
test

Service system tests

Service System Tests are password protected and provide methods for authorized users to
troubleshoot the system. Use 7378423 as the Service Id to access this group of test functions,
that are serviced from a telephone keypad. After you enter the Service ID, the screen displays
the test start menu. The following tests are available in this group:

Test Description
System audible emitter Tests if the system audible emitter is functioning properly.
test
ASTM port test Tests if the ASTM port is functioning properly.
Lamp test Tests if the lamp is functioning properly.
Motor sequence test Tests if the motor sequence is functioning properly.
Touchscreen test Tests if the touchscreen is functioning properly.
Internal and external Tests if the internal and external barcode reader is
barcode reader test functioning properly.
Troubleshooting 5-19

Test Description
Temperature test Tests if the temperature is in the correct range.
Motor position test Tests if the motor is in the correct position.
Sample and reference Tests if the sample and reference channel measurement is
channel measurement correct.
test

Service System Test menu

Use the Service System test menu to perform service tests.

Figure 5-1 Service system tests menu

Touchscreen test
Use the touchscreen test screen to test if the touchscreen is functioning properly.
5-20 Troubbl
eshoo ting

1. At the Service System Test menu, select Touchscreen.

The Touchscreen screen displays.
2. Use the alphanumeric keyboard to test the touchscreen.
The alphanumeric characters you enter display in the upper right corner.

Figure 5-2 Touchscreen test screen

Sound test
Use the speaker test screen to test the sound volume. The system emits an audible alert when
the users select the Test button. The default Sound setting is Medium.

Figure 5-3 Sound screen

Troubleshooting 5-21

Onboard barcode reader test

Use the Onboard Barcode Reader screen to test the onboard barcode reader. When the test is
complete, the barcode used in the test displays on the screen.

Figure 5-4 Onboard Barcode Reader test screen

5-22 Tro ubleshooting

External barcode reader test

Use the External Barcode Reader screen to test the external barcode reader. When the test is
complete, the barcode used in the test displays on the screen.

Figure 5-5 External Barcode Reader test screen

ASTM serial port test

Use the ASTM screen to send a test message to each configured ASTM port to verify ASTM
communication.
NOTE: This test has a 10 second timeout.
Troubleshooting 5-23

For more information see the ASTM Interface Specification, Doc. No. 16566.

Figure 5-6 ASTM screen

5-24 Tro ubleshooting

Lamp test screen

Use the Lamp screen to test the lamp. When the test is complete the voltage is displayed.

Figure 5-7 Lamp test screen

Temperature test screen

Use the Temperature screen to monitor the temperature, turn the lamp on and off, and turn the
heaters on and off. The system updates the display every 3 seconds while Monitoring is
running.
The system monitors the temperature until stopped. The system then displays the elapsed test
time and number of temperature readings taken, and reports an error if the heater temperature
is outside of the standby temperature limits.
When the user turns on Monitoring again, the summary data is cleared and the realtime
updating values are displayed.
Troubleshooting 5-25

NOTE: The user can turn Monitoring on and off an unlimited number of times. The user can
turn on and off the lamp and heaters independently from Monitoring.

Figure 5-8 Temperature test screen

5-26 Tro ubleshooting

Motor Position test screen

Use the Motor Sequence test screen to home the motor and check motor positioning. The
motor position value that corresponds to the button selected displays. There are 187 steps,
ranging from -60 (counter clockwise) to 127 (clockwise.

Figure 5-9 Motor Position test screen

Troubleshooting 5-27

Motor Sequence test screen

Use the Motor Sequence test screen to test the HbA1c or Microalbumin/Creatinine motor test
sequence. During the test, the system displays the number of cycles run and the amount of
time remaining for the current sequence cycle. The test runs until stopped, then stops after
the current test sequence cycle completes. If any errors occurred, only the E code displays.

Figure 5-10 Motor Sequence test screen

5-28 Tro ubleshooting

Measurement System test

The system turns off the lamp and collects dark readings for the sample and reference
channels. The system then turns on the lamp and waits until it is stable (15 seconds), then
collects air readings for the sample and reference channels. The system turns off the lamp
and displays the number of readings, dark signal average and standard deviation for each
channel, air signal average and standard deviation for each channel, and S/R ratio and
standard deviation.

Figure 5-11 Measurement System test screen

Maintenance 6-1

6 Maintenance

Maintenance Schedule
Weekly As Needed
Cleaning the Barcode Window Cleaning the Exterior
Cleaning the Exterior Changing the Air Filter
Quarterly Removing and cleaning the cartridge
spring
Removing and cleaning the Cleaning the Barcode Window
cartridge spring
Changing the Air Filter Running the Optical Test
Running the Optical Test Calibrating the Touchscreen
Replacing the Fuse

Cleaning the Barcode Window

WARNING: Turn the power off and disconnect the power cord before cleaning the
barcode window.

Materials required:
• lint-free cloth
• water or ethanol
6-2 Maintenance

1. Clean the barcode window with a lint-free cloth dampened with water or ethanol.

Figure 6-1 Cleaning the Barcode Window

2. Connect the power cord after the barcode window is clean and dry.

Cleaning the Exterior

WARNING: Turn the power off and disconnect the power cord before cleaning the
exterior of the system.

CAUTION: Do not allow liquid to drip into system. If liquid drips into the system, you
can damage the optics.

Materials required:
• lint-free cloth
• water or ethanol
1. Clean the exterior with a lint-free cloth dampened with water or ethanol.
2. Connect the power cord after the exterior is clean and dry.
NOTE: If you want to disinfect the exterior of the system, expose the surface to 0.5% sodium
hypochlorite for 10 minutes. Remove any liquid blood on the system before disinfection.

CAUTION: Do not use any other type of solvent, oil, grease, or silicone spray on any
part of the system.
Maintenance 6-3

Removing and cleaning the cartridge spring

WARNING: Turn the power off and disconnect the power cord before cleaning the
cartridge compartment.

CAUTION: Do not allow liquid to drip into system. If liquid drips into the system, you
can damage the optics.

BIOHAZARD: Wear personal protective equipment. Use universal precautions.

CAUTION:

Materials required:
• lint-free cloth
• water or ethanol
• paper clip or similar device
• mild detergent
• sponge swab
1. Open the cartridge compartment door as far as possible.
2. Wipe the inside surface of the compartment door and surfaces on both sides of the
compartment using a lint-free cloth dampened with water or ethanol.
3. Dry the surface using a clean, dry, lint-free cloth.
4. Locate the cartridge return spring inside the cartridge holder.
6-4 Maintenance

5. Insert the tip of a straightened paper clip (or other like device) into the top hole on the
spring.

Figure 6-2 Return Spring in Cartridge Compartment

1 Top Hole

2 Return Spring

3 Bottom Hole

6. Gently pull the metal end towards the center of the cartridge compartment to release one
side of the spring from the cartridge holder.
7. Repeat step 6 to release the other side of the spring from the cartridge holder.
8. Pull the cartridge return spring completely out of the system.
9. Clean the cartridge return spring using any of the following items:
• warm solution of mild detergent and water
• lint-free cloth dampened in water or ethanol
Maintenance 6-5

NOTE: Make sure the leaf springs are not bent or damaged while cleaning. Damaged leaf
springs do not function properly.

Figure 6-3 Return Spring

1 Return Springs

10. Dry the cartridge return spring with a clean, lint-free cloth.
11. Using a clean, dry, sponge swab (provided in the Cleaning Kit), remove spilled liquid
from the cartridge holder.

CAUTION
Do not use a cotton swab. Cotton fibers that are left on the surface
can interfere with the system’s optical systems.
6-6 Maintenance

12. Rotate the cartridge holder with the compartment door partially closed to locate and
remove any additional liquid.

Figure 6-4 Rotating cartridge compartment

13. Dampen a sponge swab with water or ethanol.
14. Clean the cartridge holder, rotating the cartridge holder as necessary.

CAUTION: Do not allow liquid to drip off of the sponge swab into the system. If liquid
drips into the system, you can damage the optics.

15. Locate the vertical grooves inside the cartridge compartment.

16. Locate the front and back slots near the top of the compartment.
17. Locate the leaf spring on one side of the cartridge return spring.
18. With the leaf spring orientated toward the back of the system, complete the following
steps to lower the leaf spring into the system:
a. Hold on to both sides of the cartridge return spring.
b. Pinch the sides together and lower the spring into the system by sliding the sides of
the spring between the vertical grooves in the compartment.
c. Release the spring.
d. Gently and carefully push down on the edge of the cartridge return spring and insert
the edge into the slot.
e. Repeat Step c to attach the opposite side of the cartridge return spring to the cartridge
compartment.
Maintenance 6-7

Changing the Air Filter

Materials required:
• air filter
1. Remove the filter holder from the back of the system:
a. Pull the holder off from the top.

Figure 6-5 Filter ___location

1 Filter Cover

2. Dispose of the old air filter.

3. Place the new air filter into the filter holder.

Figure 6-6 Removing the air filter

4. Place the filter holder back on the system.

DRAFT
6-8 Maintenance

Running the Optical Test

The optical test cartridge allows you to monitor the performance of the optical system over
time. It is recommends that you keep a permanent record of the results obtained, for example,
Mean Transmittance, Standard Deviation, and Drift.

Comparing New Values with Initial Values

Compare the new values obtained with the results recorded initially for your system. The
Mean Transmittance should be within the range of 0.9500 to 1.0500, and should not vary
more than plus or minus 0.0100. The Standard Deviation should be less than 0.0015 and the
Drift should be less than 0.0140.
1. Locate the barcode on the optical test cartridge.
2. Hold the cartridge so that the barcode faces right.
3. Insert the cartridge into the barcode track.
4. Quickly and smoothly slide the cartridge down the barcode track.
A beep sounds to signal a successful scan.

Figure 6-7 Scanning the optical test cartridge

5. Select Enter.
6. Open the cartridge compartment door.
7. Hold the optical test cartridge so that the barcode faces to the right.
8. Insert the cartridge into the compartment until you hear snap.
Maintenance 6-9

NOTE: The cartridge is designed to fit one way into the system.

Figure 6-8 Inserting optical test cartridge into compartment

9. Close the door.
10. Print the results.
11. Remove the cartridge:
a. Open the cartridge compartment door.
b. Locate the button on the right side of the cartridge compartment.
c. Push and hold it down with your right hand.
d. Gently push the plastic tab on the cartridge to the right with your left hand.
This releases the cartridge.
e. Pull the cartridge out of the compartment.
12. Compare the results obtained with results obtained initially.

Calibrating the Touchscreen

Calibrate the touchscreen if it does not respond correctly when you touch the screen.
1. At the System Test menu, select Calibrate Touchscreen.
2. When the Touchscreen Calibration screen displays, select the X target at the center of the
screen.
3. Repeat when prompted at each corner.
The Touchscreen Calibration Complete screen displays.
6-10 Maintenance

Changing the Paper

CAUTION: Do not touch the printer without observing precautions for handling
electrostatic sensitive devices. A risk of electrostatic discharge to the system exists
when touching the printer.

1. Ensure the system is at the Home screen.

2. Turn the system so that you are looking at the back.
3. Use the tab to lift the cover off.

WARNING: Be careful when touching the printer. It may be hot.

4. Lift the paper feeder up.

5. Push the plastic paper cover down.
6. Remove the paper roll:
a. Lift up the roll.
b. Tear the paper between the roll and the printer.
c. Remove the core and remaining paper on the roll.
7. Remove any paper remaining in the printer:
a. Locate the printer paper release lever.
This lever is colored gray and is located on the right of the printer when looking at
the front of the system.
b. Pinch and lift the front of the lever to raise the paper guide.
Maintenance 6-11

c. Carefully pull paper through the printer in its normal direction of travel.

Figure 6-9 Removing the printer paper

1 Printer Cover

2 Paper Feeder

3 Paper Cover

8. Obtain a new paper roll.

9. Unroll sufficient paper to feed the printer.
10. Hold the roll just above the printer, with the paper unrolling from underneath.
6-12 Maintenance

11. Push the paper gently under the roller at the back of the printer.

Figure 6-10 Inserting paper into the printer

12. Load the paper into the paper feeder.

Figure 6-11 Loading the paper into the feeder

13. Push the plastic tab to cover the paper.
14. Pull the paper feeder down.
15. Pinch and push down on the paper release lever to hold the paper in place.
16. Load the paper into the paper slot on the cover.
Maintenance 6-13

17. Close the cover.

Figure 6-12 Closing the cover

Replacing the Fuse

Materials required:
• Flathead Screwdriver
• 250 V, T-1.25 A

CAUTION: Set the power switch to OFF. Disconnect the power cord from the wall
outlet. Disconnect the power cord from the system.

1. Locate the groove on the top of the fuse holder.

2. Insert the tip of the screwdriver into the groove.
6-14 Maintenance

3. Exert pressure to unsnap the top of the fuse holder.

Figure 6-13 Removing fuse holder

1 Top and bottom grooves

4. Repeat step 2 – 3 for the bottom groove.

5. Remove the fuse holder from the system.
6. Remove and dispose of the blown fuse.

Figure 6-14 Fuse

1 Fuse

2 Fuse

3 Fuse Block

7. Insert the spare fuse onto the fuse block.

8. Insert the fuse holder into the system.

Viewing System Maintenance Status

Use the System Maintenance Status screen to view the list of maintenance tasks and the
status of each task. You can mark a task as completed at this screen, then the task displays at
the System Maintenance log screen.
Maintenance 6-15

1. At the System Menu screen, select System Maintenance.

The System Maintenance Status screen displays with the status of each task.
2. To mark a task as complete select the task.
3. Select Complete.

Setting Maintenance Reminders

Use the Maintenance Reminders screen to access the Maintenance Task Log, and to view or
change the schedule for the maintenance tasks. The default setting is that none of the
Maintenance Reminders are selected. After you select the check box for a specific reminder,
Schedule becomes active.
1. At the Additional Settings menu, select Maintenance.
The Maintenance Reminders screen displays.
2. To set a maintenance reminder, select the check box.
The maintenance reminder is set and Schedule becomes active.
3. To view the schedule, select Schedule.
The Maintenance Schedule displays.
4. To change the schedule, select Change.
The Maintenance Reminder Frequency screen displays.
5. Select one of the following frequency options:
• Daily
• Weekly
• Monthly
• Quarterly
6. Select Next.
The Set Maintenance Reminder Day screen displays.
7. Use the up and down arrows to select the day or date of the reminder.
8. Select Next.
The Maintenance Reminder Day screen displays.
9. Use the up and down arrows to set the time of the reminder.
NOTE: If a 12-hour clock is configured, you have to select AM or PM.
10. Select Next.
The Maintenance Reminder Information screen displays.
6-16 Maintenance

System Maintenance Log

Use the System Maintenance Log screen to view all complete maintenance tasks and to
delete all entries from the log.

Viewing the Maintenance Log

1. At the Additional Settings menu, select Maintenance.
The Maintenance Reminder screen displays.
2. Select Log.
The Maintenance Log screen displays.
3. Use the up and down arrows to view all of the maintenance entries.
4. To delete all maintenance log entries, select Delete All.
5. Select Yes.
All log entries are deleted.
Diagrams 7-1

7 Diagrams

Overview
The main PCB provides all of the hardware for the following areas:
• user interface processing
• realtime processing logic
• data acquisition
• control and utility functions
The main PCB interfaces with the measurement module, LCD touchscreen display, thermal
printer, and the power supply functions.

Circuit Descriptions
The following sections explain the circuit descriptions.

Microprocessor
The main DCA Vantage instrument uses a 32 bit microprocessor that operates at an internal
clock frequency of 200 megahertz. The external synchronous memory bus operates at 100
megahertz, and it includes a realtime clock and requires battery power to maintain time when
the unit is disconnected from AC power.

Nonvolatile memory
DCA Vantage includes 128 megabytes of nonvolatile memory.

Volatile memory
DCA Vantage includes 128 megabytes of standard SDRAM volatile memory.

LCD display circuitry and interface

A circuit on the main PCB converts the 3.3 volt signals from the microprocessor’s internal
display controller to the 5 volt level required for the display. The display is 5.7 inches passive
color liquid crystal display (LCD). Display contrast is controlled by varying the voltage to
the contrast input of the display.

Thermal printer circuitry and interface

The main PCB contains the printer driver circuitry for the Seiko thermal printer. The printer
has a line width of 384 dots, and can print on both normal thermal paper and thermal label
stock. Print contrast is controlled by the driver circuit in the software. A signal is sent back to
the system if the printer head is raised, or if it is out of paper.
7-2 Diagrams

UIP - serial communications port circuitry and interface

There are 3 RS232-c compatible asynchronous serial ports provided by the processor. The
first is for the LIS interface, the second is for an external barcode gun, and the third is used
for the internal barcode slot reader. The LIS and barcode ports are converted from TTL signal
levels to RS232-c levels.

UIP - USB port circuitry and interface

There is a HOST type USB 2.0 port. The port’s external power is current limited and under
control of the processors USB controller.

UIP - ethernet port circuitry and interface

There is an Ethernet communications device which allows DCA Vantage to connect to the
internet with a 10/100 base-T port. This port has a small EE prom device to store the MAC
address. The ethernet controller communicates directly to this memory device serially. The
Ethernet controller communicates to the processor through the 32 bit bus.

UIP - sound port circuitry and interface

Sound is produced on the instrument by the processor producing a variable frequency square
wave signal.

RTP - FPGA AHB logic

A Field Programmable Gate Array (FPGA) provides a logic mechanism to do the following:
• relieving the processor of the realtime burden of communicating with the analog to
digital converter and digital to analog converter
• controlling the follow of address and data bus
• communicating to the stepper motors and other miscellaneous logic functions

DAS - Pre-amplifier board interface

The main PCB supplies regulated +/- 2.5 volt regulated DC power to the Preamplifier. An 8-
pin connector on the main PCB provides the +2.5 VDC, -2.5 VDC and ground paths, in
addition to, the high impedance outputs of the sample and reference channels of the
preamplifier.

Analog to digital converter circuitry

A multiplexing analog to dialog converter is used on the main PCB which allows input from
8 inputs. These inputs include the following:
• 2 preamplifier signals sample and reference
• 3 thermistors
• 1 ground signal
• 1 reference signal
• lamp voltage
Diagrams 7-3

• current signals
The digital signals have a minimum resolution of 17 bits.

DAS - Digital to Analog converter circuitry

The FPGA on the main board can control 8 digital to analog output circuits,and uses these
outputs to precisely control the heaters, lamp, LCD brightness, motor current reference, and
measurement lamp power. The DAC circuit has a full scale range of 0 to 2.4576 volts and a
granularity of 8 bits or 9.6 milli-volts per LSB.

CONTROL - Motor and door position detector circuitry and interface

Motor and door positions are determined by photo-interrupters which are connected to the
main PCB. The main PCB supplies power and limits the current to the LED’s in each photo-
interrupter assembly which are connected to the PCB by two 5-pin connectors. The output of
the photo-interrupter is conditioned and sent to the FPGA for processing.

CONTROL - Stepper motor and circuitry and interface

The stepper motor that mixes and positions that reagent cartridge in the optical path is driven
and controlled from the main PCB by the FPGA. The motor operates at 12 VDC and has a
nominal coil resistance of 27 ohms. There is an 8-pin connector on the PCB for connection to
the motor.

CONTROL - Heater Circuitry

Heater control is performed by 2 digital to analog circuits that drive the 37 ohm heaters
operating at 12 VDC. The heater plate temperature is monitored by a thermistor on each
heater plate and the output of the thermistors are converted from analog to digital and used to
control the heater temperature.

CONTROL - Lamp drive circuitry

The lamp used is a tungsten halogen-cycle lamp whose nominal voltage rating is 3.6 volts
and whose normal current ratings is 2 amps. It is under software control via a DAC channel
to achieve a programmed soft start capability and to turn on and off under a single bit
function from the FPGA.

POWER - System status circuitry

The main board assembly has circuits, which monitor the +12 volt, +5 volt, +3.3 volt, +1.8
volt, and +1.5 volt power supplies. The processor is held in a reset state until the +3.3 volt
and the +5 volt power supplies are within range for processor operation.
7-4 Diagrams

POWER - System input and protection circuitry

A group of circuits on the main Printer Circuit Board (PCB) protect against over voltage
transients from the +5 volt and +12 volt power supply, and protect the supply from over
current fault conditions. The main PCB has a 14 pin connector that connects to the power
supply, which supplies 12+ volt power to a cooling fan located near the power supply and
connects the speaker to the system.

Figure 7-1 Block diagram of PCB

Microalbumin/Creatinine Assay
The microalbumin/creatinine cartridge assay is a quantitative measure of the concentration of
albumin in urine.To normalize measured albumin for urine volume variation, creatinine is
measured in the same cartridge and the ratio of 2 measurements is reported in addition to the
individual concentrations of albumin and creatinine. A reporting units option is available to
select between mg/dL and mmol/L units for creatinine concentration and ratio units. Ratio
units are not reported, except in the recall patient results menu.
The reagent cartridge contains all the reagents necessary for the assay. The assay requires 40
microliters of urine, pipetted into the cartridge using a dedicated capillary holder.
The microalbumin/creatinine calibration card includes a barcode on each side of the card that
provides data specific to the lot number of each microalbumin/creatinine reagent kit. You
have to scan both barcodes to enter calibration data into the instrument (Malb/C and Malb-2).
Diagrams 7-5

Microalbumin cartridge rotation sequence

The following figures illustrate the general microalbumin/creatinine cartridge rotational
sequence. The angular rotation is general for graphic purposes only and it is not true to
positioning.
NOTE: Mixing phases are not included.
1. 40 µL urine sample is collected in the microsample device.

Figure 7-2 Microsample device

2. Microsample device is inserted into the cartridge.

Figure 7-3 Insert microsample into cartridge

3. The plunger is depressed to dispense the sample.
4. The buffer release tab is removed and discarded.
7-6 Diagrams

5. Buffer solutions flows to the read area of the cartridge and a blank reading is taken.

Figure 7-4 Buffer solution in read window

6. The cartridge rotates to pick up the urine sample.

Figure 7-5 Cartridge rotates to urine sample

Diagrams 7-7

7. The cartridge rotates to the read position where sample blank reading is taken.

Figure 7-6 Cartridge rotates to read position

8. The cartridge rotates to obtain antibody regent.

Figure 7-7 Cartridge obtains antibody reagent

7-8 Diagrams

9. The cartridge rotates to the read position where microalbumin reading is taken.

Figure 7-8 Cartridge rotates to read position

10. The cartridge rotates to obtain creatinine reagents.

Figure 7-9 Cartridge rotates to obtain creatinine reagents

Diagrams 7-9

11. The cartridge rotates to the read position where creatinine reading is taken.

Figure 7-10 Cartridge rotates to read position

12. At the end of the assay, the cartridge rotates to allow the solution to flow into the
microsample holder absorbent tip.

Figure 7-11 Solution flows into absorbent pad

HbA1c and microalbumin/creatinine assay comparison

The following table provides a comparison between the HbA1c and microalbumin/creatinine
assay programs.

Function HbA1c Microalbumin/Creatinine

Screen Saver Yes Yes

Normalization cartridge Not needed Required
Sample Blood Urine
Sample volume 1 µL 40 µL
7-10 Diagrams

Function HbA1c Microalbumin/Creatinine

Volume dependency No Yes

Capillary holder Small Capillary Large Capillary
Use of plunger No Yes
Calibration card One Sided Two Sided
Test time 6 minutes 7 minutes
Result display %HbA1c Albumin, creatinine, Ratio

Selection of units None mg/dL or mmol/L for

Creatinine
units % mg/L Albumin
mg/dL or mmol/L Creatinine
mg/g or mg/mmol Ratio
Results recall 1 Screen/Sample 3 Screens/Sample
View calibration status 1 Screen/Lot 2 Screens/Lot
Error codes E101 to E116 E301 to E316
Control configuration Combined low and high control Combined low and high
control
Control card 2 sided 2 sided
Reconstitution 6 drops from dropper bottle Full contents of vial transferred
Results %HbA1c Albumin, creatinine, No Ratio

Results recall 1 screen/sample 2 screen/sample

Use life 3 months @ 4°C 3 months @ 4°C
Cartridge warm up 10 minutes in foil 15 minutes in foil
5 minutes out of foil no warm up out of foil
Time limit after 1 hour 10 minutes
removal from foil
Shelf life 24 months @ 4°C 24 months @ 4°C
Use life 3 months room temperature 3 months room temperature
Time sample allowed in 5 minutes 1 hour
capillary
Operating range 15 - 32°C / 59 - 90°F 18 - 30°C / 64 - 86°F
Diagrams 7-11

HbA1c Assay
In humans, red blood cells (erythrocytes) normally have a life span of approximately 120
days. During this period, certain components of the protein hemoglobin (within the red cells)
slowly combine with the glucose in the blood in an irreversible process referred to as
glycosylation. The higher the glucose and the longer it is elevated, the more it is retained by
the hemoglobin. Quantifying this glucose component can determine the degree of glucose
control attained by a person with diabetes.
Hemoglobin consists of several subfractions including Hemoglobin A (HbA), which
comprises 97% of the total, HbA2 is 2.5% and HbF is 0.5%. HbA is composed of glycated
subfractions collectively referred to as HbA1. Subfractions of HbA1 are HbA1a, HbA1b, and
HbA1c. HbA1c comprises 80% of HbA1 and is the subfraction of interest in terms of indexing
the degree of blood glucose control.
The quantification of HbA1c is expressed in percent (%) of total hemoglobin:

Non-diabetic 4.0 - 7.0

Diabetic > 7.0

General levels of control:

Good < 9.0

Fair 9.0 - 12.0
Poor > 12.0

The elevation in the diabetic of HbA1c was first described in the late 1960s, but testing did
not progress into clinical use until the 1980s. Clinical acceptance of the test coincided with
the clinical philosophy that the diabetic person’s glucose pattern should mimic (within
practical limits) the of the non-diabetic’s. Since the glycosylation of hemoglobin is slow and
irreversible, the HbA1c assay provides a long term diabetic metabolic control or assessment
of mean blood glucose. This allows physicians to know at a glance the degree of metabolic
control their patients have experienced over the last 60 to 120 days.
The DCA Vantage test determines both total hemoglobin and HbA1c using 1 µL blood
sample.

Capillary holder
The capillary holder is designed to obtain the test sample and insert into the reagent test
cartridge. The holder consists of a 1 µL heparinized capillary positioned at the end of a
molded plastic holder. The holder is used to obtain a 1 µL sample of blood from a finger
prick. The holder is designed to insert and lock into the test cartridge by a locking tab. When
inserted, the capillary tip comes in contact with the liquid buffer during cartridge rotation.
NOTE: Testing must be done within 5 minutes from the time blood is picked up in the
capillary holder.
7-12 Diagrams

The capillary holder contains an absorbent sponge within the plastic holder. The sponge is
used to absorb test fluid at the end of the testing sequence. The cartridge is rotated to an
absorbent picking up position where time is allowed for fluid absorption.

The test cartridge includes the following components:

• capillary holder insert and mixing channels
• barcode label
• locking tab
• optical viewing window
• buffer reagent tray with pull tab foil release
• 3 dry reagents
The assays procedure requires the following steps:
1. Insert the capillary holder with sample in to the cartridge.
2. Scan the cartridge barcode.
3. Insert the cartridge into the instrument cartridge holder.
4. Remove the pull tab foil.
5. Close the door.
The cartridge holder is located and locked at a 14.4° home/load angle when the door is
raised. The cartridge is tab locked into position when installed in the cartridge holder.
Closing the access door initiates the assay testing sequence.

Barcode label
The cartridge barcode label is designed to pass through the instrument barcode reader track.
The label must face the code reader (black dot) and can pass though the reader in either
direction.The barcode label on the test cartridge contains the HbA1c test type identification
and the reagent lot number. The cartridge barcode initiates the HbA1c processing sequence
and retrieves calibration data from the instrument memory.
Diagrams 7-13

Optical window
The cartridge optical window aligns to the cartridge holder sample channel optical aperture.
Inserting and snapping the cartridge into the instrument cartridge holder automatically aligns
the window to the holder aperture. The window is then placed in the instrument read optics
path by holder rotation.

Buffer solution (denaturant)

There are 3 dry reagents located on small elevated plastic mesas. The mesas are positioned at
specific pickup locations in the cartridge. These locations allow sequential cartridge rotation,
reagent pickup and dissolution.

Oxidant
Oxidant oxidizes hemoglobin to methemoglobin. Picked up by buffer and reconstituted with
sample during the first mixing phase. Following a mix and 2 minute reading incubation
phase, a total hemoglobin reading is taken.

Antibody latex
Antibody coated latex particles.

Agglutinator reagent
Picked up and reconstituted by cartridge rotation and mixed.

General cartridge rotation

The following figures illustrate the general cartridge rotational sequence. The angular
rotation is general for graphic purposes only and is not true to positioning.
7-14 Diagrams

1. Capillary holder with sample is inserted into the cartridge.

2. After the barcode scan, the cartridge is inserted into the instrument.
3. The buffer release tab is removed and discarded
4. The buffer solution is released into the read area of the cartridge where a blank reading is
taken.
Diagrams 7-15

5. The cartridge rotates to obtain the blood sample.

6. The cartridge rotated to the read position where a hemoglobin reading is taken.

7. The cartridge rotates to obtain antibody-latex and agglutinator reagents.

7-16 Diagrams

8. The cartridge rotates to the read position where an HbA1c reading is taken.

9. When the assay sequence is complete, the cartridge rotates to a position allowing the
liquid to flow into the capillary holder absorbent pad.

HbA1c Test Principles

In the HbA1c assay, A1c is an agglutination inhibitor. Agglutination occurs between the
antibody coated latex reagent and A1c. In the presence of A1c, agglutination is inhibited
depending upon the amount of A1c present. The instrument measures A1c by detecting the
amount of agglutination in the assay fluid. To measure agglutination, the assay fluid is
illuminated through a 531 mm interference filter. The illumination scattering effect is directly
related to the amount of agglutination inhibition. If no A1c is present, agglutination occurs
and high light scattering (absorbance) occurs. If A1c is present, agglutination is inhibited and
lower light scatter occurs.
The percent HbA1c is calculated as the ratio of HbA1c to total hemoglobin x 100.
Diagrams 7-17

Calibration Card
Each reagent kit contains a calibration card with a barcode label which is designed to pass
through the instrument barcode reader track. The calibration barcode identifies the test type,
lot number, expiration date, and calibration constants. The calibration barcode initiates
calibration data memory storage. Calibration storage data is provided for the 2 most recently
scanned lots of reagents and for up to 8 different reagent types.
Calibration constants are determined for each hemoglobin reagent lot. The constant values
are then encoded in the barcode on the calibration card.
Each normal or abnormal control contains a control card with a barcode label. The control
card identifies the test type, control lot number, level identifier, date of manufacture,
expiration range, and checksum. The checksum verifies the code integrity.

Motor timing
The cartridge holder loading and default reading positions are the same and corresponding to
the motor home position, The Home/Index sensor input provides transitions generated from
the holder post/slots which do the following:
1. Locate the home slot during homing.
2. Area accumulated during stepping sequence for confirming holder ___location.
3. Detect rotation limits at the fully CW and CCW positions.

Figure 7-12 Optical apertures and sensor slots

7-18 Diagrams

During homing a final home offset (within 4 half-steps) is determined using optical channel
readings. Readings are taken through the holder home viewing apertures for the sample and
reference channels.The offset value allows for tolerance and assembly variations between the
true optical centerline and the home sensor viewing pattern.
During cartridge rotation sequences, occurring transitions are counted by the home/transition
sensor and compared to a memory stored value required for that rotation. If the two values do
not match, an error code 12 is set and the motor inhibited. If the transition value exceeds the
CW or CCW rotation limits, error code 12 is set.

Figure 7-13 Cartridge holder posts/slots for home/index sensor

Cartridge holder homing

The following sections explain the cartridge holder homing.

Home/Index sensor
The Home/Index sensor is read to determine the which of the following is the current status:
• If blocked (H) the rotation is CCW
• If clear (L) the rotation is CW
The motor is half stepped in the direction determined and the sensor is read each step until
one of the following events occurs:
• 10 sequential clear readings (L) occur, if the motion is CCW direction, the motion is
changed to CW direction until 12 sequential block readings (H) occur.
• 12 blocked readings (H) occur, If the motion is in the CCW direction, the motion
continues until the home edge is detected. If the motion is in the CW direction, the
motion is changed to the CCW direction and continued until the home edge is found.
Diagrams 7-19

Following the CCW 12 blocked readings, the home edge is located with half stepping motion
when 3 high to low transitions occur. The home edge is indicated by the third transition.

Figure 7-14 Holder post/slot timing and motor step position

7-20 Diagrams

Optics home offset sequence

An intensity mapping sequence is used to establish the relative ___location of a read optics
centerline (sample and reference channels) to the home/index sensor pattern. The centerline
is established for the sample channel using the home/air read apertures. As the holder is
rotated, an air ratio reading is calculated from the sample and reference channel readings.
The reference channel aperture is elongated to maintain the reference signal level during the
cartridge holder home movement (reference channel air reading value).
Following the home slot ___location above, the motor is half stepped and air ratio readings
made:
• If no reading of at least half scale is read within 4 half steps, the lamp is determined as
turned off. The home position is set from the ___location determined by the home slot and
the sequence is terminated with an offset of 0.
• If a reading greater than half scale occurs, readings to locate peak transmission are made
until a sample channel reading peak is found (count drops by 150). Motor direction is
reversed until the peak reading position is found.
The half step home ___location is checked for acceptability. The home position must correspond
to a motor position with one winding energized or at a full step ___location. If the ___location is not
acceptable, a selection is made from one of the adjacent half steps. The selected step must be
within 4 half steps of the home sensor homed ___location. This offset is memory stored for use
during all subsequent motor motions.

Slot/Post pattern
The slot patterns are detailed in figures above. The full step angular displacement to the
various cartridge positions are given. The actual testing step sequence depends on the test,
for example, HbA1c.The home and read locations correspond directly to the indicated
positions. The true angular blood sample and reagent pickup with mixing do not correspond
to the actual angular post/slot position for that activity. Sample and reagent pickup is
achieved by a washing action through the cartridge rotational action. Program controlled
rotational limits achieve pickup, assure thorough mixing and avoid fluid loss by over
rotation.
Diagrams 7-21

Barcode symbology
The barcode reader is configured for interleaved 2 of 5 symbology (numerical). The barcode
must have an even number of characters including a checksum and must be bracketed by a
start and stop pattern. The maximum numbers of characters is 40. In this encoding, characters
are paired and represented by 2 wide elements and 3 narrow elements. The 5 elements are
represented by bars for the most significant digit and spaces for the least significant. This
allows high encoding density ranging up to 18 characters per inch. The encoded binary
values by position include the following:

Figure 7-15 Basic barcode

The fifth bit is a parity (P). P is utilized where necessary to give all codes exactly 2 non-zero
weights.
NOTE: Barcode symbology is subject to misreading if the barcode scan is not complete.
Reading accuracy is optimized by confirming specific barcode lengths and using a verifying
checksum.
The ratio of bars and spaces in a code must not conform to the code specifications. Problems
can occur when bar edges are smeared, rough, or when they have wide/narrow areas or
uneven quiet zones. These problems are not easy to detect unless close examination and
comparison to specifications are made.
A sample of encoded data is shown in the figure below. The figure shows the characters 6,
and 6 bar/spaces interleaved. The 9110 bar pattern illustrates a 4 digit code with a start/stop
pattern. The first 4 narrow elements (bars/spaces) are the start character for the code. The
stop pattern is a wide bar followed by 2 narrow elements (space/bar). Clear area quiet zones
are required preceding the start pattern and following the stop pattern.

Figure 7-16 Binary values by position

Motor mount assembly

The motor mount assembly includes the following components:
• stepper motor/cartridge holder assembly
• cartridge holder locking yoke
• cartridge holder home/index sensor
• lamp source/instrument optics
• detector PC board
7-22 Diagrams

The optics assembly contains a with a serviceable lamp,

detector PC board and cartridge holder assembly.

The stepper motor is secured to the motor mount with the cartridge holder assembly mounted
with the cartridge holder assembly mounted on the stepper motor shaft. The stepper motor
rotates the cartridge holder in both directions from a cartridge loading position.
Figure 7-17 Cartridge holder assembly

Stepper motor
The stepper motor is a 200 step (1.8 degrees per full step) device mechanically restricted to
340 degrees. Maximum rotation rate is 167 steps/seconds (50 rpm) program optimized for
each reagent test type (HbA1c). Optical read positions are located at full step positions. The
motor is normally operated in a half step mode during rotation. Motor timing inaccuracy is
less than 1% per half step.
All motor movements are performed with the +12VDC drive. Optical readings are taken with
one motor winding energized to provide a stable and repeatable motor state. At a motor stop
position, a 5 ms setting time is allowed between the last step of motion and switching to a
standby +5VDC value. A 200 ms settling time is then allowed before the start of a
transmission reading.
Motor rotation is inhibited when the cartridge access door is opened. An optical door sensor
monitors the door ___location by generating the signal DOOR. This signal is coupled to the
controller PCB gate array U21.
Diagrams 7-23

When the instrument is in the standby state, all motor current is disabled from the motor
drive circuit.

Figure 7-18 Motor mount assembly

Cartridge holder assembly

The cartridge holder assembly is designed to locate, lock, heat, and rotate sample test
cartridges within the optical reading area. Test cartridges insert between 2 spring loaded
heater plates and are locked in by the cartridge locking tab.
A moving heater plate adjusts a test cartridge when it is inserted. A heater plate lock keeps
this plate positioned against the cartridge. The moving plate positions against a limit edge
rail, when no cartridge is installed. A second spring loaded fixed plate is located in a plate
groove and provides a cartridge left/right reference (perpendicular). Heavier springs secure
the fixed plate forward against a limit edge rail. The locking tab on the cartridge snaps into
and locks the cartridge to the fixed plate. The cartridge is released by pressing the heater
plate lock. The lock tab positions into the moving plate slot freeing the plate move. The
cartridge may then be removed from the fixed plate by pushing it to the right and then pulling
it upward.
7-24 Diagrams

The cartridge is referenced vertically and front-back by a removable U shaped return spring.
A rear leaf on the return spring positions the cartridge forward against the two limit edge rails
described above. A bottom leaf positions the cartridge locking tab upward in the fixed plate
locking tab slot.
The 4 pressure springs are positioned and secured by upper cartridge holder tabs and by 2
bottom cover braces. The bottom cover snaps to the upper holder and is removable for
service.

Figure 7-19 Cartridge holder assembly

Slot/Post Ring
The cartridge holder assembly contains a slot/post ring which indexes to the home/index
sensor. This indexing provides positioning feedback during holder rotation to specific
locations. The ring/post locations reference to the read apertures. A cartridge sample read
aperture (sample channel) is located at the bottom of the holder. The reference channel read
aperture and sample reference channel Home/Air reading apertures are located in the holder
cover.

Heater plate assembly

The heater plate are an integrated assembly containing the following:

• 2 heater bonded aluminum plate heaters (3.4 watts each)

• A center located, silicon bonded temperature sensing thermistor on each plate. The
thermistor/plate bonding establishes the temperature set point for the assemblies:
• 37.7 +/- 0.7C°
Diagrams 7-25

These components are designed to electronically achieve the required reagent cartridge
reactivity temperature within an ambient temperature range of 15 - 32C°. Heater plate to
cartridge flatness is designed for an air gap of 0.005 inches. The thermistors are selected to
operating characteristics.
The above components are electrically connected to the controller board through a 12 inch
spiral flex cable. When the holder rotates the lead winds on the molded cable wrap portion of
the holder.

A reagent cartridge warm up period of 8 minutes is operating system controlled before

sample testing begins.

Locking yoke
A holder locking yoke locks the holder assembly at the cartridge load home position when
the cartridge door is opened. Opening the door allows the spring loaded yoke to engage a
holder locking track slot. Closing the door forces the locking yoke downward freeing the
holder to rotate on the motor shaft.

Home/Index sensor
The home/index sensor is used to sense critical cartridge holder rotary positions. The sensor
is a motor mount located to detect holder posts/slots edges at specific rotary positions. The
sensor Home/Index signal line inputs to the controller board gate array. The Home/Index
signal provides the following:
• A homing signal during cartridge holder homing
• Confirming signals during cartridge rotation to sample and reagent pickup locations, and
during mixing
When the motor is moved to a specific locations, the index signal changes state indicating
that positions.
The operating system includes the following 3 sensor failure error codes:
• E10
• E11
• E12
For more information see Troubleshooting .
7-26 Diagrams

Instrument optics

CAUTION: All DCA Systems instruments read blank corrected neutral density
and scatter filter transmissions to within the tolerances established by a
nominal or standard instrument. This tolerance testing is provided by the
individual filter test module sets and performance test software program.

The instrument optical scatter reading system is diffused transmission n design optimized for
the highest resolution possible. The system is integrated into the motor mount assembly and
consists of the source optics, cartridge holder apertures, reagent cartridge optics and detector
optics. The sample area optics include both the cartridge holder apertures and the reagent
cartridge optical window. The sample area of the optical system is stepper motor rotated
between the source and detector optics.
To compensate for lamp intensity variations during the testing period, a sample
chance/reference channel design is used. A transmission ratio between the 2 channels
compensates for variations. The sample channel measures light transmittance through the test
cartridge (reagent sample) and reference air reading aperture. The reference channel
measures reference light levels through air read apertures. Light source variation affect both
channels proportionally. The ratio between the 2 channels is directly proportional to the light
available without regard to light source variations.

Figure 7-20 Instrument optics

Diagrams 7-27

Source optics
The source optics are designed to create a controlled beam of light to illuminate 2 optical
channels. The source optics consist of a incandescent halogen lamp, 0.025 inch collimating
aperture, spacer, and lens. The lamp and source components are mounted in a metal holder to
maintain illumination alignment under thermal conditions. The nominal lamp tip on axis
distance from the aperture is 1.5 mm (0.06 inch). The lamp is positioned and mounted by
dowel pins to minimize heat transfer and lamp heat temperature shift. A flat screw secures
the lamp and aids in temperature shift. A 531 nm interference filter mounts into the source
housing cap and is secured by 1 or 2 foam O rings as required. The source optics assembly
locates into a molded area on the motor mount. Instrument mounting is self aligned by guides
on the mount which locate the cap, and by a fixed vertical pin guide into a base mount slot.
The vertical dowel pin establishes the assembly positioning the motor mount.
Light from the collimation aperture strikes the lens and is formed into a controlled beam. The
beam passes through the 531 nm filter. 531 nm is the active wavelength of chemistries tested
on the DCA System. The band pass output of the filter is then formed into the sample and
reference channels by source exit apertures molded into motor mount. These two channels
pass through the sample area optics (cartridge/holder) to the detector optics. Each channel is
independently illuminated and isolated during readings.
Figure 7-21 Source optics assembly

Cartridge/Holder optics
The cartridge holder optics consists of the following:
• read apertures (sample and reference channels)
• home/air apertures (sample and reference channels)
• dark reading locations
The apertures are designed to align with the source and detector optics as the cartridge is
rotated. Reagent cartridge readings occur at the read apertures. the reference channel aperture
is an air reading. The home/air apertures are used during the cartridge holder homing
sequence and for air readings during sample testing. Air readings establish the air ratio. Dark
or offset readings are taken at a cartridge ___location between the read apertures and home/air
apertures. This ___location blocks light source transmission during lamp on times providing the
electronic offset value.
The reagent cartridge optical window is designed for the following:
• 5.1 mm square light entry window
• 2 mm read area (cylinder)
• 1 cm optical path length (standard cover)
The cartridge holder and cartridge window design accommodates the 2 mm detector optic
read cylinder. The 1 cm cartridge optical path length is maintained at +/- 0.11 mm (0.0043
inch) maximum to minimize cartridge to cartridge path length variations. The cartridge
optical window is specified to be free of chips, scratches, oil, flash, or any marks. Each
window surface is specified or 91% transmission with no defects.
7-28 Diagrams

Detector optics
The detector optics consists of serrated collimating tubes for each channel which couple to
photodiode/preamplifier detectors. The collimating tubes are fixed in the motor mount and
align to the lamp source exit apertures. The selected length of the tubes maximize
transmittance to the photodiodes. The internal tube serrations establish the 2mm read area
cylinder with a 5 degree read angle cone for minimizing internal stray light. The read
cylinder optimizes scatter resolution and allows a usable scatter range of 10% to 100%
The 2mm read area cylinder establishes a 0.5 mm read movement across the optic window
for each motor half step (0.9 degree). The actual read ___location is established in the center of
the read aperature.

Figure 7-22 Cartridge optical window

 Appendix A A-1

A Appendix A Service Release Testing

This appendix is covers the following topics:

A Overview and table of contents................................................................................... A-1

A.1 Computer Requirements ............................................................................................. A-2
A.2 Installation................................................................................................................... A-2
A.3 Running the test software.......................................................................................... A-14
A.4 Saving Data............................................................................................................... A-16
A.5 Updating the Application.......................................................................................... A-17
A.6 Uninstalling the application ...................................................................................... A-17
A.7 DCA Vantage Service Release Protocol Check list.................................................. A-18
Appendix A A-2

A.1 Computer Requirements

The test software is designed to run on a PC running Windows XP. The PC will require
Microsoft .NET framework 1.1 and Access 2002 to be installed prior to installing the test
software. The PC will require a serial port for communication with the instrument.
Connection to a printer is optional.

Microsoft .Net framework 1.1 is provided on the software CD as dotnetfx.exe. This is an

executable file that when selected will install Microsoft .Net framework 1.1 on the computer.

Microsoft .Net framework 1.1 can also be downloaded from www.microsoft.com/downloads

Search for framework 1.1 and download.

A.2 Installation
The application is installed from the CD. Run Setup.exe

A.2.1 Procedure
1. Verify that Microsoft Access 2002 is installed on the PC that is being used. If it is not
installed obtain a copy and install it.
2. Verify that Microsoft .Net framework 1.1is installed on the PC. If it is not then insert the
CD contain the test software and find the file “dotnetfx.exe”. Run this program.
3. The test software application is installed from the CD by Run “Setup.exe”. This will take
you through the installation process. It will add an icon to the Desktop. Double-clicking
this icon will run the application.
4. Any updates to the application will require the existing database to be renamed prior to
uninstalling the application. Note: If this process is not followed the data in the
existing Database will be overwritten.
Appendix A A-3
Appendix A A-4
Appendix A A-5
 Appendix A A-6

A.2.2 Configuring the software

1. First operation is to click on “scan badge”. An initial service account “000” is
included for initial log on activity. Enter this number via the keyboard and press
“Enter”. All service engineers can use this account or they can create individual
accounts.
Appendix A A-7

2. Next click on “Edit Configuration

3. A set of configuration screens will now be displayed in a “Tab” format.

4. Personnel tab to open personnel settings. Press “Add” to enter more personnel. First
and last name are obvious, works number will be their log-on ID (up to a max of
10characters). Select “Roles” tab and check “Engineer” and “Active” box. This will
allow the engineer to run tests, change configuration details and add other users.
Click on “Save”.
Appendix A A-8

5. Under the Configuration Details tab, the initial installation will point to the Access
database. Ensure that this is always adhered to in the Service environment.
6. The “list installed printer” will detail printers available, and show the default printer.
7. Printer configuration is default to “off”. If the printer configuration is set to “on” it
will automatically print a report at the end of the test, if set as default (“off”), an
option to print is available at the end of the test.
8. The default serial port for instrument communication is “1”, if this port is not
available, a message will be displayed, and alternative ports can be selected via the
drop-down box.
9. Save new configurations before exiting.
Appendix A A-9

10. The Specification Details tab contains the specification limit values for DCA Vantage
and previous models. Note these are identical currently, so this feature is there for
future-proofing. It also refers back to the source of these values and communication
settings, again common for all instruments. These values should not be changed in-
less directed to via service bulletin!
Appendix A A-10
Appendix A A-11
Appendix A A-12
Appendix A A-13

11. The Calibration Details tab allows service engineers to add new filter set values and
update as necessary. These assigned values should be taken from the A1CSTD file
from Mishawaka.
12. Use the “Add” button to create new details. Enter the filter set number in the box (3
digits, including any leading zeros) in the right hand corner and assigned values
(X.XXX) and calibration details. “Save” details before exiting. Double clicking on
the number of an existing entry will reveal the assigned values and calibration details
for that set, which can then be updated. “Save” details before exiting.
13. Press “Cancel” to exit the “Edit Configuration” panel.
 Appendix A A-14

A.3 Running the test software

A.3.1.1 Running Tests –

1. Clicking the “Run Test” button will then require the following details to be entered.
2. Model selection by drop-down box.
3. Serial number by keyboard.
4. Filter set details by pressing “scan” and entering the 3 digit number via the keyboard
and pressing “Enter”.
5. Press “Start test run” to commence testing.

A.3.1.2 The first 7 tests

Test 1 through 7 are hardware tests used primarily for Manufacturing, and do not involve
communication between the DCA and the PC. Service can effectively bypass these first
seven tests by pressing “Pass” through tests1 to 7, but remembering to connect the serial
cable before commencing filter tests.

1. The 1st test instructs the user to connect the serial cable, and that the instrument is
ready for test. Press “Pass” to continue, “Fail to abort”.
2. The 2nd test instructs the user to enter the serial number into the DCA. Press “Pass” to
continue, “Fail to abort”.
 Appendix A A-15

3. The 3rd test instructs the user to check the operation of the speaker. Press “Pass” to
continue, “Fail to abort”.
4. The 4th test instructs the user to check the operation of the touchscreen. Press “Pass”
to continue, “Fail to abort”.
5. The 5th test instructs the user to check the operation of the internal printer. Press
“Pass” to continue, “Fail to abort”.
6. The 6th test instructs the user to check the operation of the fan. Press “Pass” to
continue, “Fail to abort”.
7. The 7th test instructs the user to look for any adverse conditions that are not covered
by the previous tests. Press “Pass” to continue, “Fail to abort”. Pressing “Fail” will
allow the user to record the observations.

A.3.1.3 Optical Filter Tests

The next series of tests are the Optical Filter tests. These are run in the same order as
previous systems –
ND Blank
Hi
Test
Lo
Var ND
Scatter Blank
Scatter
Normalization

1. To run these tests carefully follow the on-screen instructions on the PC. When
installing filters into the instrument, carefully follow the instructions on the DCA.
Once “Start test” has been pressed, the test has to run to completion. A countdown
timer displays the maximum time left to complete the test. Note that when the test
completes and the data transfers to the PC, the test cycle progresses regardless of the
countdown timer. A total of 3 opportunities to test each filter are available to allow
any cleaning of filters, etc. A “Cancel test run” button is available at the completion
of any individual filter test; data is not saved to the database in this instance.

2. After the filter testing has been completed, the instrument must be reset, following the
on-screen instructions on the PC. Press “Pass” to continue, “Fail to abort”.
3. The report details for the test are then presented on-screen.
 Appendix A A-16

A.3.1.4 Printing a Report

Dependant on printer settings, a printout is either automatic or an option. In the report “Pass”
or “Fail” conditions for each test are presented, if a “Fail” condition occurs additional
information is presented.

A.4 Saving Data

Data is saved onto the local Access database. This can be found at C:\Program Files\Product
support\DCA Tester\Database.

The following notes give a brief explanation of the database structure for guidance in the
event that the Service group needs to write queries to the database.

Within the database structure the starting point in extracting data is the tblTestRuns. From
this table the serial number of the instrument can be found and this will correspond to an “id”
field. Using this “id number” in the tblFilterTests, the “filter id’s” for that test run can be
found. Using those “filter id’s” in the tblFilters the pass/fail status can be found. Individual
filter test data can then be extracted from the tables listed below. These contain the individual
test values, limits and pass/fail status.

Listing of tables containing filter test data –

tblFilterDataAbsorbance
tblFilterDataBlankCorrected
tblFilterDataCF
tblFilterDataCVMax
tblFilterDataDrift
tblFilterDataMean
tblFilterDataMinute
tblFilterDataPreAmpGain
tblFilterDataSD
tblFilterDataStep
tblFilters
tblFilterTests
tblTestRuns

Other tables within the database –

tblUsers
tblUsersInRoles
tblRoles
tblGenericTests
tblFilterSpecifications
tblFilterCalibrations
 Appendix A A-17

A.5 Updating the Application

Any updates to the application will require the existing database to be renamed prior to
uninstalling the application. Note: If this process is not followed the data in the existing
Database will be overwritten.

A.6 Uninstalling the application

Uninstalling the application is achieved using the Add/remove programs within the PC
Control Panel, found in Start, Settings.
 Appendix A A-18

A.7 DCA Vantage Service Release Protocol Check list

Decontaminate the Instrument □

Review the instrument error log □
Confirm Complaint □
Remove cases and clean any dust out of inside of instrument. □
Verify that all cables are seated and locked □
Verify that all labels are in place and in good condition □
Clean and Inspect that cosmetically the instrument is in good condition □
Replace the fan filter media □
Reassembly the instrument □
Calibrate the touchscreen □
Perform the touchscreen test □
Verify Software version is current □
Perform internal printer test □
Perform external printer test □
Perform internal barcode reader test □
Perform external barcode reader test □
Perform serial port test using either 9-pin loop back connector or
using HyperTerminal on PC. □
Ethernet port check using either an Ethernet port tester or using the
remote function in the manufacturing set-up screens □
Perform the motor position test □
Perform the Precision and Drift test □
Perform the optical performance test □
Reset instrument error logs □
Reset System □
Instrument Serial Number: _____________
Optical Performance Filter set used _______________ Calibration Date ____________
Service by _____________________________ Date:____________________
Comments:
 3-157

Appendix C LIS Interface Specifications

Overview
This section defines the data codes, transmission protocols, error recovery, and message
content of communication between the DCA Vantage system (the instrument) and a
laboratory computer (the host).
The DCA Vantage system is capable of supporting a serial connection and/or an Ethernet
connection between instrument and host. The serial interface is mechanically and electrically
compatible with the EIA-232-D Standard. The Ethernet interface is established through the
instruments RJ45 internet connection.
The DCA Vantage system supports the ASTM Specification E1381, Low-Level Protocol to
Transfer Messages between Clinical Laboratory Instruments and Computer Systems. The
system also supports the ASTM Specification E1394, Standard Specification for Transferring
Information between Clinical Instruments and Computer Systems.
The following are ASTM messages transferred from instrument to host:
• HbA1c reagent test result records
• Microalbumin/Creatinine reagent result records
• Filter Test Cartridge result records
• Control Test result records
The following are ASTM messages transferred from host to instrument:
• Force Control remote commands
• Remote Lockout remote commands
For more information about setting up LIS specifications, see the DCA Vantage Operator’s
Guide.

External Documents
Use the documents in the following table as a reference.

Doc. No. Specification Status

ASTM E1381- Low-Level Protocol to Transfer Messages between Released
95 Clinical Laboratory Instruments and Computer
Systems
ASTM E1394- Standard Specification for Transferring Information Released
97 between Clinical Instruments and Computer Systems
3-158

LIS Terminology
The following table defines terms used for LIS interface specification:

Term Description
Establishment This is the phase in the ASTM 1381 protocol that determines the
Phase direction of information flow between instrument and host. The sender
requests to send by issuing an <ENQ>. The receiver accepts the request
by issuing an <ACK>.
Filter Test A test used to verify the optical performance of the instrument. These are
also known as Optical tests.
Frame A frame is a subdivision of an ASTM 1381 message. It is used to allow
periodic communication between devices. A message containing 240
characters or less is sent in a single frame. Larger messages are broken up
into multiple frames.
Host Any laboratory computer system as defined by the ASTM 1381 standard.
These computer systems typically collect reports from the instrument
and/or send remote commands to the instrument.
Instrument The DCA Vantage system is a Clinical Laboratory Instrument as defined
by the ASTM 1381 protocol.
Message A message is a collection of related information. It is the textual body of
information that is transmitted between instrument and host during one
session. Message can consist of many different types of records.
Session A session is a total unit of communication activity between instrument
and host as defined by the ASTM 1381 protocol. The session begins with
the establishment phase and ends with the termination phase.
Termination This is the phase in the ASTM 1381 protocol during which the sender
Phase relinquishes its control of the communication link by issuing an <EOT>.
After the termination phase, the communication link is returned to a
neutral state.
Transfer Phase This is the phase in the ASTM 1381 protocol during which the sender
sends messages to the receiver.

Low Level Protocols

Low level protocols supported by the DCA Vantage system are largely defined by the ASTM
1381 standard. The exception to that statement is the establishment of an Ethernet physical
link which is a logical extension of that specification.

Physical layer
The Physical Layer refers to the point-to-point connection between the DCA Vantage system
(the instrument) and a laboratory computer system (the host).
 3-159

Serial connection
The serial transmission between the instrument and the host is established through the
instrument's serial port using a serial cable. The mechanical and electrical connection for
serial binary data bit transmission between instrument and computer system is described in
the serial physical layer. The DCA Vantage system implements and complies with serial
physical layer defined in the ASTM 1381 standard. For additional information about this
layer, please refer to the standard.

Ethernet connection
TCP/IP transmission between the instrument and the host is established through the
instrument's Ethernet network adapter using a RJ45 connector. The DCA Vantage system
only supports the instrument connecting to the host. This means that the host needs to listen
for connections on a TCP/IP port and needs to accept the connection when the instrument
tries to connect.

Data link layer

The Data Link Layer operates the same whether the physical connection is serial or Ethernet.
The DCA Vantage system implements and complies with the Data Link layer defined in the
ASTM 1381 standard. For additional information about this layer, please refer to the
standard.
The Data Link Layer has procedures for link connection and release, delimiting and
synchronism, sequential control, error detection, and error recovery. Link connection and
release establishes which system sends and which system receives. Delimiting and
synchronism provide for framing of the data and recognition of frames. Sequence control
maintains the sequential order of information across the connection. Error detection senses
transmission and format errors. Error recovery attempts to recover from detected errors by
retransmitting defective frames.

Data link overview

Specific information defining the data link layer is contained in the ASTM standard. This
section provides overview so that the reader has a general understanding of the data link
layer.
Information flows one direction at a time. When one side wants to send a message to the
other, it must first establish the direction of communication. The sender sends and enquiry
character <ENQ>. If the receiver is ready to receive, it will return a acknowledgement
character <ACK>. Once the direction is established, the sender sends a frame or sequence of
frames to the receiver. Transmission frames contain framing characters, data content, and
checksum. The receiver verifies the checksum and returns and acknowledgement to the
sender.
3-160

Sample data link transmission

The following table displays a sample transmission from instrument to host:

Direction Term Definition

ESTABLISHMENT PHASE
Instrument to Host <ENG> Request to establish direction
Host to Instrument <ACK> Request accepted, Direction established
TRANSFER PHASE
Instrument to Host <STX> Start of text, start of frame
Instrument to Host FN single digit Frame number (0 through 7)
Instrument to Host Text Data content of the message
Instrument to Host <ETX> End of Text, Transmission control character
Instrument to Host Checksum 2 character checksum, Hex
Instrument to Host <CR><LF> End of Frame
Host to Instrument <ACK> Acknowledgement
TERMINATION PHASE
Instrument to Host <EOT> End of transmission, Both sides return to
Neutral state

Record Structure and Content

The low level protocols define how messages are transferred between instrument and host.
This section describes the actual content of the messages.
The record structure and content of DCA Vantage system messages are defined by the ASTM
1394 specification. This section provides an overview of that structure. For a complete
understanding of that structure, please refer to the ASTM specification.

ASTM message structure

Once the direction of communication is established between instrument and host, the sender
will send a message to the receiver. The sender will send one message per transfer session.
The message content is transferred in the text portion of the ASTM 1381 transmission frame.
 3-161

Records within a message

ASTM messages contain records. Records are separated by a carriage return character <CR>.
All messages begin with a Message Header Record and end with a Message Terminator
Record.
The following is an example of a simple message from instrument to host:
H|\^&|||DCA Vantage^1.0.0.0|||||||P||20060823235959<CR>
L|1|N<CR>

Fields within a record

ASTM records contain fields. Fields are identified by their position within the record. Fields
are delimited by the field separator character (vertical bar, |, ASCII 124). A field's position is
obtained by counting the field delimiters from the front of the message. If a field has no
value, its field delimiter will appear directly after the previous delimiter. If the record has no
additional fields with values, it is not necessary to provide the delimiters for those fields.
In the example:
H|\^&|||DCA Vantage^1.0.0.0|||||||P||20060823235959<CR>

"H" is field 1, "\^&" is field 2, "DCA Vantage^1.0.0.0" is field 5, "P" is field 12, and
"20060823235959" is field 14.
NOTE: In ASTM Records, the first field is always the record type.

Components within a fields

An ASTM field can contain more than one value. Multiple values within a field are separated
by the Component Delimiter (the Caret, ^, ASCII 94).
In the example:
H|\^&|||DCA Vantage^1.0.0.0|||||||P||20060823235959<CR>

Field 5 contains "DCA Vantage^1.0.0.0". This field contains 2 values separated by the
component delimiter.

Record types
An ASTM message consists of a hierarchy of records of various types. In ASTM Records,
the first field is always the record type. The following record types are used by the DCA
Vantage system:
• Message Header Record (H)
• Patient Record (P)
• Order Record (O)
• Result Record (R)
• Comment Record (C)
• Manufacturing Record (M)
• Message Terminator Record (L)
3-162

Message header record (H)

The Message Header record marks the beginning of a message. It contains information about
the sender. It also defines the field, repeat field, component field, and escape delimiter
characters. It will always be the first record sent in a message.

Field # Field Definition

1 Record Type H
2 Delimiter Definition The 4 characters that follow the record type (H) define the
delimiters potentially used in the message. The character
immediately following the record type is the 1st field
delimiter of the record and will be used to define all field
delimiters for the message. The 3 characters of the 2nd field
define the repeat delimiter (\), the component delimiter (^),
and the escape delimiter (&).
4 Access Password Required when the host sends a Remote Command Request
to the instrument.
5 Sender Information Sender Information is a component field.
When the instrument sends this information, it will be in the
following format: "<product-code>^<software-version>".
12 Processing ID This field indicates how the message is to be processed.
P = Production (the message contains clinical results)
D = Debugging (the instrument is in service mode)
14 Data and Time This is the date and time of the message transmission. The
format of this field is YYYYMMDDHHmmSS. Where
YYYY is the 4 digit year, MM is the 2 digit month, DD is
the 2 digit day of month, HH is the hour of day (0 through
24), mm is the minutes, and ss is the seconds.

Example record from instrument (clinical results):

H|\^&|||DCA Vantage^1.0.0.0|||||||P||20061002200015<CR>
 3-163

Message Terminator record (L)

The Message Terminator record marks the end of a message. It will always be the last record
sent in a message.

Field # Field Definition

1 Record Type L
2 ASTM Sequence 1
Number
3 Terminator Code N = Normal Termination

Example:
L|1|N<CR>

Patient information record (P)

The Patient information record contains information about a sample that applies to every
record of that sample.

Field # Field Definition

1 Record Type P
2 ASTM Sequence 1,2,3...
Number
3 Patient ID Practice Assigned Patient ID. (This field is not sent if we are
in Service Mode 1)
6 Patient Name Component Field: <last name>^<first name> (patient
samples only, only if entered, not in manufacturing mode
1)(This field is not sent if we are in Service Mode 1)

Example:
P|1|987654|||Doe^Jane<CR>

Test order record (O)

For the DCA Vantage system, this record is only sent from the instrument to the host to
provide the instrument sequence number for the test result.

Field # Field Definition

1 Record Type O
2 ASTM Sequence 1,2,3... etc
Number
3-164

Field # Field Definition

4 Instrument Specimen From instrument to host, according to test type:
ID • For patient results: 001 through 999 (sample sequence
number)
• For controls selected by barcode: Control Level ID,
Control Lot Number, and Reagent Lot Number (e.g.
"C#1^9003^9012") (note upper case 'C').
• For controls selected by menu: Control Level ID and
Reagent Lot Number (e.g. "c#1^^9012") (note
lowercase 'c').
• For Filter Test Cartridge (standard number) (barcode
generated): "S<n>" where <n> is the test type (e.g.
"S1") (note uppercase 'S')(S1 = Procession and Drift
test, S2 = Precision Only test, S3 = Normalization
Factor test).
• For menu run standard function (standard number):
"s<n>" where <n> is the test type (e.g. "s1") (note
lowercase 's').
12 Action Code Q = when control is run, else unused

Example for clinical specimen:

O|1||018<CR>

Example for control solution selected by barcode:

O|1||C#1^9003^9012||||||||Q<CR>

Example for control solution selected by menu:

O|1||c#1^^9012||||||||Q<CR>

Example for Filter Test Cartridge selected by barcode:

O|1||S1<CR>

Example for Filter Test selected by menu:

O|1||s1<CR>

Result record (R)

Each Result record contains the result of a single test determination. For H1bAc reagent
assay results, there is 1 Result record per test. For Microalbumin/Creatinine reagent assay
results, there are 3 records for a patient result and 2 records for a control result. For the
Precision and Drift filter test, there are 2 Result records per test. For the Precision test or
MNF test, there is one Result record per test.
 3-165

Result records are only transmitted from instrument to host. A result record can never appear
without a preceding patient record.

Field # Field Definition

1 Record Type R
2 ASTM Sequence 1,2,3...
Number
3 Universal Test ID Clinical Mode:
^^^HbA1c
^^^Alb
^^^Crt
^^^Ratio
Run Standard Mode:
^^^Precision
^^^Drift
4 Data or Clinical Mode:
Measurement Test result value.
Run Standard mode (component field):
Precision test value = <mean transmittance>^<standard
deviation>
Drift test value = <mean transmittance>^<drift>
5 Units Clinical mode:
Units of measurement:
HbA1c = "%"
Alb = "mg/L"
Crt = "mg/dL" or "mmol/L"
Ratio = "mg/g" or "mg/mmol"
7 Abnormal result < = Below instrument measurement range
flags > = Above instrument measurement range
H = Above reference range (HbA1c only)
N = Within reference range (HbA1c only)
L = Below reference range (HbA1c only)
11 Operator ID User ID of the instrument user who performed the test.
(only if entered)(not in manufacturing mode 1)
12 Date and Time Date and Time the test analysis began

Example clinical result - HbA1c below instrument measurement range:

R|1|^^^HbA1c|2.5|%||<|||||20061023112233<CR>
3-166

Example clinical result - HbA1c below reference range:

R|1|^^^HbA1c|3.8|%||L|||||20061023112233<CR>

Example clinical result - HbA1c within normal range:

R|1|^^^HbA1c|5.3|%||N|||||20061023112233<CR>

Example clinical result - HbA1c above reference range:

R|1|^^^HbA1c|12.8|%||H|||||20061023112233<CR>

Example clinical result - HbA1c above instrument measurement range:

R|1|^^^HbA1c|14|%||>|||||20061023112233<CR>

Example clinical result - Microalbumin/Creatinine below instrument measurement range:

R|1|^^^Alb|5.0|mg/L||<|||||20061023112233<CR>
R|1|^^^Crt|15|mg/dL||<|||||20061023112233<CR>
R|1|^^^Ratio|---|mg/g|||||||20061023112233<CR>

Examples of Filter Test Cartridge results:

R|1|^^^Precision|0.1379^0.00015||||||||20061023112233<CR>
R|1|^^^Drift|1.0019^0.0017||||||||20061023112233<CR>

Manufacturer information record (M)

Manufacturer Information records are used to transmit custom data between instrument and
host. Here is the general format of a Manufacturing Information Record.

Field # Field Definition

1 Record Type M
2 ASTM Sequence 1,2,3...
Number
3 MF1 Manufacturing Field 1
4 MF2 Manufacturing Field 2
... ...
14 MF12 Manufacturing Field 12

There are seven Manufacturing Record Types used by the DCA Vantage system. They are:
• Remote Command request record (host to instrument)
• Remote Command response record (instrument to host)
• Begin Data record - General information about a test (Service mode 1 or 2)
• Raw Data record - Raw data readings for a test (Service mode 1 or 2)
• Microalbumin Normalization Factor record (Service mode 1 or 2)(Microalbumin/
Creatinine test only)
• Temperature Readings record (Service mode 2 only)
• Total Hemoglobin record (Service mode 2 & HbA1c tests only)
 3-167

Remote command request record

The DCA Vantage system will only accept remote commands if the proper password is
provided in the ASTM Message Header Record (H). The proper password for Remote
Command ASTM messages is "Service".
Manufacturing records for Remote Command Requests contain the following data:

Field Definition
MF1 "C" Indicator for Remote Command Request
MF2 MF2 Remote command request type:
"h" Force High Microalbumin/Creatinine Control
"l" Force Low Microalbumin/Creatinine Control
"a" Force Abnormal HbA1c Control
"n" Force Normal HbA1c Control
"s" Set Patient Lockout
"c" Clear Patient Lockout
MF3 The token provided by the host to identify the remote command request.

Example - remote command completed:

M|1|D|completed|9080<CR>

Remote command response record

The following table shows which responses can be received in response to a given remote
command request.

Field Definition
MF1 D Indicator for Remote Command Response
MF2 Remote command response:
"invalid login" User did not specify proper password in the ASTM
Header record
"Invalid request" Remote command type requested was invalid
"pending" System is Busy. System will force the control once
ready.
"started" System started the requested operation.
"completed" System completed the requested operation.
"timeout" Timeout waiting for the operation to start.
"error" Error occurred while processing the requested
operation.
MF3 The token provided by the host to identify the remote command request.
3-168

Example - remote command completed:

M|1|D|completed|9080<CR>

Expected responses to remote commands

The following table shows which responses can be received in response to a given remote
command request.

Invalid Invalid Pendin Started Complete Timeout Error

Login Reques g d
t
Force High M/C Yes No Yes Yes Yes Yes Yes
Control
Force Low M/C Yes No Yes Yes Yes Yes Yes
Control
Force Normal Yes No Yes Yes Yes Yes Yes
HbA1c

Force Abnormal Yes No Yes Yes Yes Yes Yes

HbA1c

Set Patient Lockout Yes No No No Yes No No

Clear Patient Yes No No No Yes No No
Lockout
Unknown Command No Yes No No No No No

Begin data record

The first manufacturing record for a result message contains general information about the
test. There are four formats of this record differs based on test type (HbA1c test, Filter test,
M/C test, and MNF test).
Begin data records contain the following data

HbA1c Filter M/C MNF Definition

MF1 MF1 MF1 MF1 R - Indicator for Result Information Record

MF2 MF2 MF2 MF2 begin - Response tag
MF3 40 digit calibration bar code if running a reagent
cartridge
MF4 Cartridge bar code - 6 digit reagent or 12 digit filter test
MF5 Control bar code - 20 digits (if running a control from bar
code)
MF4 Filter test cartridge barcode
 3-169

HbA1c Filter M/C MNF Definition

MF3 M/C side 1 cal barcode

MF4 M/C side 2 cal barcode
MF5 M/C test cartridge barcode
MF6 M/C control barcode
MF5 MNF Test barcode
MF6 MF6 MF7 MF7 Sample channel preamp gain (NA - always 2)
MF7 MF7 MF8 MF8 Sample channel PGA gain (NA - always 100)
MF8 MF8 MF9 MF9 Reference channel preamp gain (NA - always 2)
MF9 MF9 MF10 MF10 Reference channel PGA gain (NA - always 100)
MF10 MF10 MF11 MF11 Home offset - number of steps from optical home
position to interrupt trip point
MF11 MF11 MF12 MF12 N - number of readings averaged to produce reported
measurements

Example of "begin" Manufacturing record:

M|1|R|begin|1234567890123456789012345678901234567890|123456||1|140|1|143|0|16<CR>

Raw data records

Most manufacturing records for a result contain measurement information from the
instrument. Those records contain the following data::

Field Definition
MF1 R - Indicator for Result Information Record
MF2 Tag - Text label - "air1", "dark1", etc…
MF3 Test time (10th of seconds from start of test)
MF4 Motor position (steps from optical home)
MF5 Mean sample channel reading (in millivolts)
MF6 Mean reference channel reading (in millivolts)
MF7 Mean S/R ratio (sample/reference)
MF8 C.V. of sample channel reading (in %)(coefficient of variance)
MF9 C.V. of reference channel reading (in %)
MF10 C.V. of S/R ratio
MF11 Transmittance (mean sample position / mean air position)
3-170

Example of "air1" Manufacturing record:

M|3|R|air1|123|8|3731.8|3722.5|1.002092|0.040|0.042|0.025|1.00000<CR>

Temperature record
The Temperature record contains the following data:

Field Definition
MF1 R - Indicator for Result Information Record
MF2 HTRL or HTRR - Response Tag (heater left & heater
right)
MF3 Average temperature during test
MF4 Maximum temperature during test
MF5 Minimum temperature during test

Example of Temperature Manufacturing records:

M|77|R|HTRL|37.9|38.2|37.5 <CR>
M|78|R|HTRR|37.9|38.2|37.5 <CR>

MCRF record
The Microalbumin Normalization Factor record contains the following data:

Field Definition
MF1 R - Indicator for Result Information Record
MF2 MCRF - Response Tag
MF3 Normalization factor

Example of "MCRF" Manufacturing record:

M|79|R|MCRF|0.993 <CR>

THB record
The Total Hemoglobin record contains the following data:

Field Definition
MF1 R - Indicator for Result Information Record
MF2 THB - Response Tag
MF3 Total Hemoglobin value
MF4 Measurements units
 3-171

Example of "THB" Manufacturing record:

M|68|R|THB|10.0|%<CR>

Comment records (C)

Comment records may be inserted anywhere between the message header record and the
message terminator record. Each comment record shall apply to the first non-comment
record preceding it. Comment records have the following format:

Field Definition
MF1 C
MF2 1,2,3...
MF3 I Clinical instrument system
MF4 1 to many record specific text strings separated by a
component delimiter
MF5 G General/Free text comment

The DCA Vantage system uses comment records as follows:

Transmit GFR Result and input data
C|1|I|<age>^<gender>^<race>^<creatinine input>^<gfr result>|G<CR>

Before HbA1c results, transmit User Correction Slope, Offset, and Algorithm
C|1|I|1.000^0.0 %^default|G<CR>

Order Comment Information (if entered)(one for each comment entered).

C|1|I|comment<n>^<comment-n-text>|G<CR>

Test result message structure

An ASTM Message is a collection of ASTM records as defined above. When the instrument
sends test result messages to the host, there is a hierarchical order to the records as follows
Header Record
Patient Record 1
Test Order Record 1
0 through 8 Comment Records (if entered)
Result Record 1
Message Terminator Record

Modes of Operation
The DCA Vantage system can operate in one of three modes, service mode disabled, service
mode 1, and service mode 2. Test result messages sent from the instrument to the host differ
based on the mode of operation. The following sections give an overview of these
differences.
3-172

Service mode disabled

If the service mode is disabled, the system creates a Customer message for the current test in
progress. Customer messages have the following notable characteristics:
• Message Header Processing ID = P for Production.
• User ID is sent in the Result Record if entered
• No manufacturing messages will be sent to the host
• Comment records are transmitted if the user entered text for patient demographics.

Service mode 1
If service mode 1 is enabled, the system creates a Manufacturing Mode 1 message for the
current test in progress. Manufacturing Mode 1 messages have the following notable
characteristics:
• Message Header Processing ID = D for Debug
• User ID is not sent with the Result Record
• Manufacturing messages are sent to the host with the results
• Manufacturing messages contain:
• Manufacturing Mode Header
• Raw Data Readings of optics channels
• Microalbumin Normalization Factor if Microalbumin/Creatinine test
• No Comment records are transmitted in Service Mode 1

Service mode 2
If service mode 2 is enabled, the system creates a Manufacturing Mode 2 message for the
current test in progress. Manufacturing Mode 2 messages have the following notable
characteristics:
• Message Header Processing ID = D for Debug
• User ID is sent with the result record if entered
• Comment records are transmitted if the user entered text for patient demographics.
• Manufacturing messages are sent to the host with the results
• Manufacturing mode 2 message contain:
• All Manufacturing records for mode 1
• Temperature Readings
• Hemoglobin information if HbA1c test

Transmit Use-Cases
This section describes use-cases that involve transmission of ASTM message between the
DCA Vantage system and the LIS host. It also describes the messages transmitted during
those use-cases.
 3-173

HbA1c test results

HbA1c test results are transmitted from instrument to host after patient tests, control tests, or
when the transmit button is pressed during recall of an HbA1c test.

Service mode disabled

H|\^&|||DCA Vantage^1.0.0.0|||||||P||20061002200015<CR>
P|1|987654|||Doe^Jane<CR>
C|1|I|age^39|G<CR>
O|1||333<CR>
R|1|^^^HbA1c|2.5|%||<|||||20061002183420<CR>
L|1|N<CR>

Service mode 1 enabled

H|\^&|||DCA Vantage^1.0.0.0|||||||D||20061002200015<CR>
P|1<CR>
O|1||333<CR>
M|1|R|begin…<CR>
M|2|R|…<CR>
M|3|R|…<CR>
…
M|65|R|…<CR>
R|1|^^^HbA1c|5.3|%||N|||||20061002183420<CR>
L|1|N<CR>

Service mode 2 enabled

H|\^&|||DCA Vantage^1.0.0.0|||||||D||20061002200015<CR>
P|1|987654|||Doe^Jane<CR>
C|1|I|age^39|G<CR>
O|1||333<CR>
M|1|R|begin…<CR>
M|2|R|…<CR>
M|3|R|…<CR>
…
M|65|R|…<CR>
M|66|HTRL|37.9|38.2|37.5<CR>
M|67|HTRL|37.9|38.2|37.5<CR>
M|68|THB|10.0|%<CR>
R|1|^^^HbA1c|14.0|%||>|||||20061002183420<CR>
L|1|N<CR>
3-174

Microalbumin/Creatinine test results

Microalbumin/Creatinine test results are transmitted from instrument to host after patient
tests, control tests, or when the transmit button is pressed during recall of one of these tests.

Service mode disabled

H|\^&|||DCA Vantage^1.0.0.0|||||||P||20061002200015<CR>
P|1|987654|||Doe^Jane<CR>
C|1|I|age^39|G<CR>
O|1||333<CR>
R|1|^^^Alb|105|mg/L|||||||20061002183420<CR>
R|2|^^^Crt|125|mg/dL|||||||20061002183420<CR>
R|3|^^^Ratio|84.0|mg/g|||||||20061002183420<CR>
L|1|N<CR>

Service mode 1 enabled

H|\^&|||DCA Vantage^1.0.0.0|||||||D||20061002200015<CR>
P|1 <CR>
O|1||333<CR>
M|1|R|begin…<CR>
M|2|R|…<CR>
M|3|R|…<CR>
…
M|76|R|…<CR>
M|77|R|MCRF|0.993<CR>
R|1|^^^Alb|5.0|mg/L||<|||||20061002183420<CR>
R|2|^^^Crt|15.0|mg/dL||<|||||20061002183420<CR>
R|3|^^^Ratio|---|mg/g|||||||20061002183420<CR>
L|1|N<CR>

Servie mode 2 enabled

H|\^&|||DCA Vantage^1.0.0.0|||||||D||20061002200015<CR>
P|1|987654|||Doe^Jane<CR>
C|1|I|age^39|G<CR>
O|1||333<CR>
M|1|R|begin…<CR>
M|2|R|…<CR>
M|3|R|…<CR>
…
M|76|R|…<CR>
M|77|HTRL|37.9|38.2|37.5<CR>
M|78|HTRL|37.9|38.2|37.5<CR>
M|79|R|MCRF|0.993<CR>
 3-175

R|1|^^^Alb|5.0|mg/L||<|||||20061002183420<CR>
R|2|^^^Crt|15.0|mg/dL||<|||||20061002183420<CR>
R|3|^^^Ratio|---|mg/g|||||||20061002183420<CR>
L|1|N<CR>

Filter test result

Filter test results are transmitted from instrument to host after a Precision and Drift Filter test.

Service mode disabled

H|\^&|||DCA Vantage^1.0.0.0|||||||D||20061002200015<CR>
P|1<CR>
O|1||S1<CR>
R|1|^^^Precision|0.7085^0.00026||||||||20061002183420<CR>
R|2|^^^Drift|0.9981^0.0041||||||||20061002183420<CR>
L|1|N<CR>

Service mode 1 enabled

H|\^&|||DCA Vantage^1.0.0.0|||||||D||20061002200015<CR>
P|1<CR>
O|1||S1<CR>
M|1|R|begin…<CR>
M|2|R|…<CR>
M|3|R|…<CR>
…
M|74|R|…<CR>
R|1|^^^Precision|0.7085^0.00026||||||||20061002183420<CR>
R|2|^^^Drift|0.9981^0.0041||||||||20061002183420<CR>
L|1|N<CR>

Service mode 2 enabled

H|\^&|||DCA Vantage^1.0.0.0|||||||D||20061002200015<CR>
P|1<CR>
O|1||S1<CR>
M|1|R|begin…<CR>
M|2|R|…<CR>
M|3|R|…<CR>
…
M|74|R|…<CR>
M|75|HTRL|37.9|40.0|25.0<CR>
M|76|HTRL|37.9|40.0|25.0<CR>
R|1|^^^Precision|0.7085^0.00026||||||||20061002183420<CR>
R|2|^^^Drift|0.9981^0.0041||||||||20061002183420<CR>
3-176

L|1|N<CR>

Remote commands

Remote commands ASTM message

The host may send a remote command request to the instrument.
H|\^&||password|hostdevice^hostversion|||||||P||20061002200015<CR>
M|1|C|h|9080<CR>
L|1|N<CR>

Remote command response ASTM message

The instrument sends remote command responses to the host.
H|\^&|||DCA Vantage^1.0.0.0|||||||D||20061002200015<CR>
M|1|D|completed|9080<CR>
L|1|N<CR>

Service Mode Data Records

This section defines the sequence of Data Records sent from the instrument to the host as part
of an ASTM test result message. Data Records are a specific type of Result Information
Records. Result Information Records are Manufacturing Records with an 'R' in the MF1
field. These records are only sent when the instrument is in Service Mode 1 or Service Mode
2.
The overall format of an ASTM test result message is described in Section 5, Transmit Use-
Cases. The format of a Manufacturing record is described in Section 3.2.6, Manufacturer
Information Record (M). This section describes the specific sequence of Data records
provided for each test type.

HbA1c service mode records

The following table describes the sequence of service mode records sent in an HbA1c test
result message (patient test or control test).

Response Tag Description Approximate Time in Assay

dark1 Dark reading 1
air1 Air reading 1
buff<X> 10 records, Buffer readings 1 35 through 40 seconds
through 10
dark2 Dark readings 2
air2 Air reading 2 42 seconds
dark3 Dark reading 2
 3-177

Response Tag Description Approximate Time in Assay

air3 Air reading 3 118 seconds
pkup1<x> 5 records 143 through 239 seconds
dark4 Dark reading 4
air4 Air reading 4 241 seconds
hb<x> 10 records. Hb readings 1 262 through 269 seconds
through 10
dark5 Dark reading 5
air5 Air reading 5 270 seconds
dark6 Dark reading 6
air6 Air reading 6 303 seconds
CAL<x> 26 agglutination records. One 305 through 307 seconds
reading every 5 seconds, where
<x> = 035, 040, ..., 160
dark7 Dark reading 7
air7 Air reading 7 372 seconds

Microalbumin/Creatinine service mode records

The following table describes the sequence of service mode records sent in a Microalbumin/
Creatinine test result message (patient test or control test).

Response Tag Description Approximate Time in Assay

dark1 Dark reading 1
air1 Air reading 1
buff<X> 10 records, Buffer readings 1 Buff 10 at 36 seconds
through 10
dark2 Dark readings 2
air2 Air reading 2 38 seconds
Sb1_<x> 5 records. Sample bank 1, reps 1
through 5
Sb2_<x> 5 records. Sample bank 2, reps 1 Sb_25 at 87 seconds
through 5
dark3 Dark reading 2
air3 Air reading 3
3-178

Response Tag Description Approximate Time in Assay

Sb3_<x> 5 records. Sample bank 3, reps 1 Sb3_5 at 118 seconds
through 5
dark4 Dark reading 4 284 seconds
air4 Air reading 4
MCR174 174 sec. Microalbumin reading 300 seconds
MCR<x> 8 records. <x> sec
Microalbumin reading. Where
<x> = 176, 178, 180, ..., 190
MCR192 192 sec. Microalbumin reading 348 seconds
dark5 Dark reading 5
air5 Air reading 5
dark6 Dark reading 6
air6 Air reading 6
CRT0400 40 sec. Creatinine reading 363 seconds
CRT<x> 24 records. <x> tenths of second
Creatinine readings. Where <x>
= 0416, 0432, 0448, ..., 0784
CRT0800 40 sec. Creatinine reading 363 seconds
dark7 Dark reading 7
air7 Air reading 7
MCRF Microalbumin Normalization
Factor used to generate results

Precision and drift test service mode records

The following table describes the sequence of service mode records sent in a Precision and
Drift (S1) result message.

Response Tag Description Approximate Time in Assay

dark1 Dark reading 1
air1 Air reading 1
td1 Drift reading 1
tp1 Precision reading 1
 3-179

Response Tag Description Approximate Time in Assay

th<x> 9 records. Window measuremnt 14 to 19 seconds
readings where <x> = 1 through
9
dark2 Dark reading 2
air2 Air reading 2 20 seconds
td2 Drift reading
tp2 Precision reading
dark3 Dark reading 3
air3 Air reading 3 25 seconds
td3 Drift reading 3
tp3 Precision reading 3
dark4 Dark reading 4
air4 Air reading 4 30 seconds
td4 Drift reading 4
tp4 Precision reading 4
dark5 Dark reading 5
air5 Air reading 5 36 seconds
td5 Drift reading 5
tp5 Precision reading 5
dark56 Dark reading 6
air6 Air reading 6 40 seconds
td6 Drift reading 6
tp6 Precision reading 6
dark7 Dark reading 7
air7 Air reading 7 46 seconds
td7 Drift reading 7
tp7 Precision reading 7
dark8 Dark reading 8
air8 Air reading 8 51 seconds
td8 Drift reading 8
3-180

Response Tag Description Approximate Time in Assay

tp8 Precision reading 8
dark9 Dark reading 9
air9 Air reading 9 56 seconds
td9 Drift reading 9
tp9 Precision reading 9
dark10 Dark reading 10
air10 Air reading 10 61 seconds
td10 Drift reading 10
tp10 Precision reading 10
dark11 Dark reading 11
air11 Air reading 11 66 seconds
td<x> 20 records. Drift readings 11 80 to 365 seconds
through 30. Once every 15
seconds. <x> = 11 through 30
dark12 Dark reading 12
air12 Air reading 12 366 seconds