UNIVERSITY OF MALTA
FACULTY OF MEDICINE & SURGERY
PHARMACY DEPARTMENT
Ref. No.
SOP/PD/221_02
STANDARD OPERATING PROCEDURE
DCA 2000® ANALYSER
Page 1 of 43
Valid for:
2 years from
approval
UNIVERSITY OF MALTA
FACULTY OF MEDICINE & SURGERY
PHARMACY DEPARTMENT
Ref. No.
SOP/PD/221_02
STANDARD OPERATING PROCEDURE
DCA 2000® ANALYSER
Valid for:
2 years from
approval
1. Scope
This Standard Operating Procedure (SOP) applies to the staff and students using the
DCA 2000 Analyser in the Pharmacy Practice Resource Unit (PPRU) at the
Pharmacy Department, University of Malta.
2. Objective
To describe the procedure for the set-up, calibration, operation, quality control,
maintenance and troubleshooting of the DCA 2000 Analyser.
3. Definitions
3.1.
Bar Code: A machine readable set of data storing information regarding the
item it is attached to.
3.2.
Bar Code Track: The area where a reagent cartridge, optical test cartridge,
calibration card or control card are placed prior to scanning their bar code.
3.3.
Calibration Card: A card that is provided with each reagent kit and used to
calibrate the device. The calibration card for the HbA1c reagent kit has one bar
code available whilst the calibration card for the microalbumin / creatinine
reagent kit has 2 bar codes, one on each side of the card, that both must be
scanned to ensure a successful calibration.
3.4.
Capillary: Used to obtain a small volume of sample using capillary action.
3.5.
Capillary Holder: Holds the capillary in place during sample acquisition.
3.6.
Cartridge Compartment: The area which holds the reagent cartridge during
an analysis and the optical test cartridge during an optical test.
3.7.
Cartridge Return Spring: Part of the mechanism that allows a cartridge to be
removed from the cartridge compartment.
3.8.
Cleaning Kit: Contains a number of sponge swabs that are used to clean the
cartridge compartment.
3.9.
Control Card: Contains a specially designed control bar code to be used in
conjunction with a control solution. The control card for the HbA1c test is
double sided; one side for Normal results (C1) and the other for Abnormal
Page 2 of 43
UNIVERSITY OF MALTA
FACULTY OF MEDICINE & SURGERY
PHARMACY DEPARTMENT
Ref. No.
SOP/PD/221_02
STANDARD OPERATING PROCEDURE
DCA 2000® ANALYSER
Valid for:
2 years from
approval
results (C2). The control card for the microalbumin / creatinine test is also
double sided; one side for Low results (C1) and the other for High results (C2).
3.10. Control Solution: Used to perform a quality control test, where it is analysed
in the same manner as a patient sample. Two control solutions are available for
both the HbA1c and the microalbumin / creatinine tests i.e. Normal / Abnormal
and Low / High respectively.
3.11. Display: Indicates date, time, error messages, test results as well as procedural
commands. Screen saver is activated when the device is not in use for more
than 5 minutes and any key can be pressed to return it to normal display before
performing any other function.
3.12. Dot: A mark used to help identify the location of the bar code reader window.
3.13. Filter Holder: Holds a replaceable air filter in place to prevent dust
contamination.
3.14. Haemoglobin A1c (HbA1c) Test: A quantitative test used to measure the
percentage concentration of glycosylated haemoglobin in the blood, providing
an indicator of the mean daily blood glucose concentration over the preceding
two months.
3.15. Main Menu: Consists of 9 sub-menus i.e. [RECALL PREVIOUS TESTS?],
[SET SEQUENCE NUMBER?], [RECALL CONTROL RESULTS?], [VIEW
CALIBRATION STATUS?], [SET DATE/TIME?], [INSTRUMENT SETUP?],
[SET CREATININE UNITS?], [INSTRUMENT TEST?] and [RUN
CONTROL?] (SOP/PD/221_02/A1 and SOP/PD/221_02/A2).
3.16. Microalbumin Creatinine Ratio: A test used in diabetics to determine the
occurrence and degree of kidney disease, where abnormal values indicate an
increased risk of developing heart and blood vessel complications.
3.17. Optical Test Cartridge: A cartridge that is used to allow the user to verify the
performance of the optical system of the device and to check that this was not
damaged or contaminated during the cleaning of the cartridge compartment.
3.18. Program Card: Contains all the necessary data to operate the device.
3.19. Program Card Connector: The area on the device where the program card is
inserted.
Page 3 of 43
UNIVERSITY OF MALTA
FACULTY OF MEDICINE & SURGERY
PHARMACY DEPARTMENT
Ref. No.
SOP/PD/221_02
STANDARD OPERATING PROCEDURE
Valid for:
2 years from
approval
DCA 2000® ANALYSER
3.20. Quality Control Test: A test used to ensure that the device is giving
appropriate results within acceptable limits.
3.21. Reagent Cartridge: Holds the sample during the analysis. Different reagent
cartridges are available for each test i.e. HbA1c and microalbumin / creatinine.
3.22. Venipuncture: The process of puncturing a vein by a sharp rigid stylet,
cannula or by a needle attached to a syringe or catheter for withdrawing a
sample of blood, instilling a medication, starting an IV infusion or for injecting
a radiopaque substance for radiologic examination of a part or system of the
body.
4. Responsibility
4.1.
The members of the Department of Pharmacy (staff and students) are
responsible for following this SOP.
4.2.
The designated Laboratory Officer or Laboratory Assistant is responsible for
ensuring that this SOP is followed.
5. Procedure
5.1.
Diagram of DCA 2000 Analyser
Keys
Display
Bar Code Track
Dot
Cartridge
Compartment
Air Filter
Holder
Page 4 of 43
UNIVERSITY OF MALTA
FACULTY OF MEDICINE & SURGERY
PHARMACY DEPARTMENT
Ref. No.
SOP/PD/221_02
STANDARD OPERATING PROCEDURE
DCA 2000® ANALYSER
5.2.
Valid for:
2 years from
approval
Set-Up
5.2.1.
5.2.2.
5.2.3.
Place the device on a firm, level surface.
Check that the power switch is set to the Off (O) position.
Insert the program card into the program card connector with its label
facing upwards.
5.2.4. Connect the power cord to the power cord connector socket.
5.2.5. Plug in the power cord to an electricity outlet.
5.2.6. Set the power switch to the On (I) position.
5.2.7. Wait for a few minutes until the device warms up.
5.2.8. Press the [MENU] button to access the Main Menu.
5.2.9. Repeatedly press the [NEXT] button to scroll through the different submenus available.
5.2.10. Press the [ENTER] button to select the desired sub-menu.
5.2.11. See SOP/PD/221_02/A1 to set-up each sub-menu.
5.2.12. Press the [ESCAPE] button to exit the Main Menu.
5.3.
Calibration
5.3.1.
Calibrating device for HbA1c
5.3.1.1.
5.3.1.2.
5.3.1.3.
5.3.1.4.
5.3.1.5.
5.3.1.6.
5.3.1.7.
5.3.1.8.
5.3.1.9.
5.3.1.10.
5.3.1.11.
5.3.1.12.
5.3.1.13.
5.3.2.
Set the power switch to the On (I) position.
Wait for a few minutes until the device warms up.
Check that no test is in progress before attempting to
perform a calibration.
Locate the dot on the device next to the bar code track.
Locate the bar code on the calibration card.
Hold the calibration card in a way that the bar code faces
right.
Insert the calibration card into the bar code track above the
dot.
Hold the calibration card against the right side of the bar
code track.
Quickly slide the calibration card down past the dot.
Check that a beep is heard to ensure a successful scan.
Repeat 5.3.1.4 to 5.3.1.9 if no beep is heard.
Contact the supplier if a beep repeatedly fails to be heard.
Set the power switch to the Off (O) position.
Calibrating device for Microalbumin / Creatinine
5.3.2.1.
Repeat 5.3.1.1 to 5.3.1.12.
Page 5 of 43
UNIVERSITY OF MALTA
FACULTY OF MEDICINE & SURGERY
PHARMACY DEPARTMENT
Ref. No.
SOP/PD/221_02
STANDARD OPERATING PROCEDURE
DCA 2000® ANALYSER
5.3.2.2.
5.3.2.3.
5.4.
Valid for:
2 years from
approval
Repeat 5.3.1.4 to 5.3.1.12 within less than 5 minutes, using
the other side of the calibration card.
Set the power switch to the Off (O) position.
Operation
5.4.1.
Performing a Haemoglobin A1c test
5.4.1.1.
5.4.1.2.
5.4.1.3.
5.4.1.4.
5.4.1.5.
5.4.1.6.
5.4.1.7.
5.4.1.8.
5.4.1.9.
5.4.1.10.
5.4.1.11.
5.4.1.12.
5.4.1.13.
5.4.1.14.
5.4.1.15.
5.4.1.16.
5.4.1.17.
5.4.1.18.
5.4.1.19.
5.4.1.20.
Set the power switch to the On (I) position.
Wait for a few minutes until the device warms up.
Take out a reagent cartridge pack from the refrigerator.
Remove the reagent cartridge from its foil package and let it
stand for about 5-10 minutes at ambient temperature.
Check that the capillary holder to be used has an absorbent
pad, a glass capillary and a properly working latching
mechanism.
Hold the capillary holder at an angle.
Touch the tip of the capillary to a small drop of blood on the
finger, if the blood sample is going to be obtained from a
finger prick.
Touch the tip of the capillary to a blood sample present on
the lid of a blood collection tube after mixing the blood
sample well, if the blood sample is going to be obtained
from a venipuncture sample.
Wipe the outside surface of the capillary with a lint-free
tissue.
Discard the capillary holder together with the capillary in a
biohazard container and start the test again if bubbles are
present in the capillary.
Position the capillary holder in the correct orientation for
insertion into the reagent cartridge.
Gently insert the capillary holder into the reagent cartridge
until the capillary holder gently snaps into place.
Locate the dot next to the bar code track.
Locate the bar code on the reagent cartridge.
Hold the reagent cartridge in a way that the bar code faces
right.
Insert the reagent cartridge into the bar code track above the
dot.
Quickly slide the reagent cartridge down past the dot.
Check that a beep is heard to ensure a successful scan.
Repeat steps 5.4.1.13 to 5.4.1.17 if no beep is heard.
Contact the supplier if a beep repeatedly fails to be heard.
Page 6 of 43
UNIVERSITY OF MALTA
FACULTY OF MEDICINE & SURGERY
PHARMACY DEPARTMENT
Ref. No.
SOP/PD/221_02
STANDARD OPERATING PROCEDURE
DCA 2000® ANALYSER
Valid for:
2 years from
approval
5.4.1.21. Wait for [LOAD CARTRIDGE] to be displayed.
5.4.1.22. Open the cartridge compartment door.
5.4.1.23. Hold the reagent cartridge in a way that the bar code faces
right.
5.4.1.24. Insert the reagent cartridge into the cartridge compartment.
5.4.1.25. Check that the cartridge has snapped into place.
5.4.1.26. Pull the flexible plastic pull-tab completely out of the
reagent cartridge.
5.4.1.27. Close the cartridge compartment door.
5.4.1.28. Wait for 5 seconds for a beep to be heard to indicate that the
test has started.
5.4.1.29. Press the [ESCAPE] button and then the [ENTER] button if
the test needs to be cancelled at any time.
5.4.1.30. Wait for the test to be performed.
5.4.1.31. Use the [MENU] button (SOP/PD/221_02/A1) to recall the
test result if more than 15 minutes has elapsed from when
the test was finished.
5.4.1.32. Record the displayed result.
5.4.1.33. Open the cartridge compartment door.
5.4.1.34. Push and hold down, with the right hand, the button situated
on the right side of the cartridge compartment.
5.4.1.35. Gently push, with the left hand, the plastic tab on the reagent
cartridge to the right to release the reagent cartridge.
5.4.1.36. Remove the reagent cartridge from the cartridge
compartment.
5.4.1.37. Discard the reagent cartridge in a biohazard container.
5.4.1.38. Set the power switch to the Off (O) position.
5.4.2.
Performing a Microalbumin / Creatinine Test
5.4.2.1.
5.4.2.2.
5.4.2.3.
5.4.2.4.
5.4.2.5.
5.4.2.6.
5.4.2.7.
Repeat 5.4.1.1 to 5.4.1.4.
Check that the capillary holder to be used has an absorbent
pad, a glass capillary, a properly working latching
mechanism and a starch plug that is not situated at the
bottom of the capillary tube.
Immerse the tip of the capillary tube in the urine sample to a
level just above the capillary starch plug.
Allow enough time for the urine sample to flow up the
capillary tube and come into contact with the starch plug.
Remove the capillary tube from the urine sample.
Re-immerse the capillary tube in the urine sample, if the
urine flows back down the capillary tube.
Repeat 5.4.1.9 to 5.4.1.20.
Page 7 of 43
UNIVERSITY OF MALTA
FACULTY OF MEDICINE & SURGERY
PHARMACY DEPARTMENT
Ref. No.
SOP/PD/221_02
STANDARD OPERATING PROCEDURE
DCA 2000® ANALYSER
5.4.2.8.
5.4.2.9.
5.4.2.10.
5.4.2.11.
5.4.2.12.
5.4.2.13.
5.4.2.14.
5.4.2.15.
5.4.2.16.
5.5.
Valid for:
2 years from
approval
Wait for [LOAD CARTRIDGE, INSERT PLUNGER] to be
displayed.
Repeat 5.4.1.22 to 5.4.1.25.
Insert the plunger into the hole found in the top of the
capillary holder.
Fully depress the plunger into the capillary holder to lock it
in place.
Press the [ENTER] button.
Repeat 5.4.1.26 to 5.4.1.30.
Use the [MENU] button (SOP/PD/221_02/A1) to recall the
test result if more than 15 minutes has elapsed from when
the test was finished.
Record the displayed results for albumin, creatinine and the
albumin / creatinine ratio.
Repeat 5.4.1.33 to 5.4.1.38.
Quality Control
5.5.1.
Analysing control for Haemoglobin A1c
5.5.1.1.
5.5.1.2.
5.5.1.3.
5.5.1.4.
5.5.1.5.
5.5.1.6.
5.5.1.7.
5.5.1.8.
5.5.1.9.
5.5.1.10.
5.5.1.11.
5.5.1.12.
5.5.1.13.
5.5.1.14.
5.5.1.15.
5.5.1.16.
Set the power switch to the On (I) position.
Wait for a few minutes until the device warms up.
Remove the 2 HbA1c control vials and a reagent cartridge
from the refrigerator.
Reconstitute the lyophilised controls using the solvent
provided.
Remove the reagent cartridge from its foil package and let it
stand for about 5-10 minutes at ambient temperature.
Check that the capillary holder to be used has an absorbent
pad, a glass capillary and a properly working latching
mechanism.
Locate the dot next to the bar code track on the device.
Choose the correct side of the control card according to the
control solution to be used first.
Locate the bar code on the control card.
Hold the control card in a way that the bar code faces right.
Insert and hold gently the control card against the right side
of the bar code track above the dot.
Quickly slide the control card down past the dot.
Check that a beep is heard to ensure a successful scan.
Repeat steps 5.5.1.7 to 5.5.1.12 if no beep is heard.
Contact the supplier if a beep repeatedly fails to be heard.
Press the [ENTER] button.
Page 8 of 43
UNIVERSITY OF MALTA
FACULTY OF MEDICINE & SURGERY
PHARMACY DEPARTMENT
Ref. No.
SOP/PD/221_02
STANDARD OPERATING PROCEDURE
DCA 2000® ANALYSER
Valid for:
2 years from
approval
5.5.1.17. Hold the capillary holder at angle.
5.5.1.18. Mix well the contents of the control solution.
5.5.1.19. Touch the tip of the capillary to the control solution present
on the lid of the control solution tube.
5.5.1.20. Repeat 5.4.1.9 to 5.4.1.20
5.5.1.21. Wait for [LOAD CONTROL] to be displayed.
5.5.1.22. Repeat 5.4.1.22 to 5.4.1.27.
5.5.1.23. Press the [ESCAPE] button and then the [ENTER] button if
the test needs to be cancelled at any time.
5.5.1.24. Wait for the test to be performed.
5.5.1.25. Press the [ESCAPE] button to display the value of an out-ofrange control if [CONTROL OUT OF RANGE] is displayed.
5.5.1.26. Use the [MENU] button (SOP/PD/221_02/A1) to recall the
test result if more than 15 minutes has elapsed from when
the test was finished.
5.5.1.27. Record the displayed result and compare it with the result
range present in the package insert of the control solution.
5.5.1.28. Repeat 5.4.1.33 to 5.4.1.37.
5.5.1.29. Repeat 5.5.1.5 to 5.5.1.28 using the second control solution.
5.5.1.30. Set the power switch to the Off (O) position.
5.5.2.
Analysing control for Microalbumin / Creatinine
5.5.2.1.
5.5.2.2.
5.5.2.3.
5.5.2.4.
5.5.2.5.
5.5.2.6.
5.5.2.7.
5.5.2.8.
5.5.2.9.
5.5.2.10.
5.5.2.11.
5.5.2.12.
5.5.2.13.
Set the power switch to the On (I) position.
Wait for a few minutes until the device warms up.
Remove the 2 Microalbumin / Creatinine control vials and a
reagent cartridge from the refrigerator.
Reconstitute the lyophilised controls using the solvent
provided.
Remove the reagent cartridge from its foil package and let it
stand for about 5-10 minutes at ambient temperature.
Check that the capillary holder to be used has an absorbent
pad, a glass capillary, a properly working latching
mechanism and a starch plug that is not situated at the
bottom of the capillary tube.
Repeat 5.5.1.7 to 5.5.1.19.
Repeat 5.4.1.9. to 5.4.1.20.
Wait for [LOAD CARTRIDGE, INSERT PLUNGER] to be
displayed.
Repeat 5.4.1.22 to 5.4.1.25.
Repeat 5.4.2.10 to 5.4.2.12.
Repeat 5.4.1.26 to 5.4.1.27.
Repeat 5.5.1.23 to 5.5.1.26.
Page 9 of 43
UNIVERSITY OF MALTA
FACULTY OF MEDICINE & SURGERY
PHARMACY DEPARTMENT
Ref. No.
SOP/PD/221_02
STANDARD OPERATING PROCEDURE
DCA 2000® ANALYSER
Valid for:
2 years from
approval
5.5.2.14. Repeat 5.4.1.33 to 5.4.1.37.
5.5.2.15. Repeat 5.5.2.5 to 5.5.2.14 using the second control solution.
5.5.2.16. Set the power switch to the Off (O) position.
5.6.
Maintenance
5.6.1.
5.6.2.
5.6.3.
Check that the device is switched Off before cleaning its exterior
surface.
Clean the outside of the device with a moist lint-free cloth.
If blood is present on the exterior surface of the device:
5.6.3.1.
Expose the exterior surface to either a 0.5% sodium
hypochlorite or a 2% glutaraldehyde solution for 10
minutes.
5.6.4.
Allow the device to completely dry before attempting to switch it On.
5.6.5.
Clean the cartridge compartment on a quarterly basis or depending on
the duration of use of the device:
5.6.5.1.
5.6.5.2.
5.6.5.3.
5.6.5.4.
5.6.5.5.
5.6.5.6.
5.6.5.7.
5.6.5.8.
5.6.5.9.
5.6.5.10.
5.6.5.11.
5.6.5.12.
5.6.5.13.
5.6.5.14.
Check that the device is switched Off.
Open the cartridge compartment door as far as possible.
Clean the inside surface with a moist lint-free cloth.
Dry the inside surface with a dry lint-free cloth.
Locate the cartridge return spring containing two holes at its
periphery.
Insert the tip of a straightened paper clip into the top hole of
the spring.
Gently pull this end of the spring towards the centre of the
cartridge compartment to release one side of the spring.
Insert the tip of a straightened paper clip into the bottom
hole of the spring.
Gently pull this end of the spring towards the centre of the
cartridge compartment to release the other side of the spring.
Pull the cartridge return spring completely out of the
cartridge compartment.
Clean the cartridge return spring with a moist lint-free cloth.
Dry the cartridge return spring with a dry lint-free cloth.
Remove any spilled liquid from the cartridge holder using a
clean, dry sponge swab provided in the Cleaning Kit.
Rotate the cartridge holder while the cartridge compartment
door is partially closed to locate and remove any additional
liquid that might still be present.
Page 10 of 43
UNIVERSITY OF MALTA
FACULTY OF MEDICINE & SURGERY
PHARMACY DEPARTMENT
Ref. No.
SOP/PD/221_02
STANDARD OPERATING PROCEDURE
DCA 2000® ANALYSER
Valid for:
2 years from
approval
5.6.5.15. Clean the cartridge holder with a moist sponge swab and
rotate the holder as necessary.
5.6.5.16. Locate the vertical grooves and the front and back slots
inside the cartridge compartment.
5.6.5.17. Locate the leaf spring on one side of the cartridge return
spring.
5.6.5.18. Orient the leaf spring towards the back of the device.
5.6.5.19. Hold the cartridge return spring from both sides near the
holes.
5.6.5.20. Pinch both sides of the cartridge return spring and lower it
into the device by sliding the sides of the spring between the
vertical grooves in the compartment.
5.6.5.21. Check that the cartridge return spring can freely slide up and
down within the cartridge compartment.
5.6.5.22. Gently push down one edge of the cartridge return spring
and insert it into the slot.
5.6.5.23. Repeat 5.6.5.22 to attach the opposite side of the cartridge
return spring to the cartridge compartment.
5.6.5.24. Check that the leaf spring of the cartridge return spring is
oriented towards the back of the device.
5.6.5.25. Check that the cartridge return spring is securely attached
via the grooves to the cartridge compartment.
5.6.6.
Run an optical test after cleaning the cartridge compartment and
whenever the performance of the optical system needs to be verified:
5.6.6.1.
5.6.6.2.
Locate the bar code on the optical test cartridge.
Hold the optical test cartridge in a way that the bar code
faces right.
5.6.6.3. Insert the optical test cartridge into the bar code track above
the dot on the device.
5.6.6.4. Quickly slide the cartridge down past the dot.
5.6.6.5. Check that a beep is heard to ensure a successful scan.
5.6.6.6. Repeat steps 5.6.5.1 to 5.6.5.4 if no beep is heard.
5.6.6.7. Contact the supplier if a beep repeatedly fails to be heard.
5.6.6.8. Press the [ENTER] button when [RUN STANDARD 1] is
displayed.
5.6.6.9. Open the cartridge compartment door.
5.6.6.10. Hold the optical test cartridge in a way that the bar code
faces right.
5.6.6.11. Insert the optical test cartridge into the cartridge
compartment.
5.6.6.12. Check that the optical test cartridge has snapped into place.
Page 11 of 43
UNIVERSITY OF MALTA
FACULTY OF MEDICINE & SURGERY
PHARMACY DEPARTMENT
Ref. No.
SOP/PD/221_02
STANDARD OPERATING PROCEDURE
Valid for:
2 years from
approval
DCA 2000® ANALYSER
5.6.6.13. Close the cartridge compartment door.
5.6.6.14. Wait for 6 minutes for the test to be performed.
5.6.6.15. Record the displayed results for transmittance, standard
deviation and drift.
5.6.6.16. Open the cartridge compartment door.
5.6.6.17. Push and hold down with right hand the button situated on
the right side of the cartridge compartment.
5.6.6.18. Gently push the plastic tab on the cartridge to the right with
the left hand to release the optical test cartridge.
5.6.6.19. Pull the optical test cartridge out of the cartridge
compartment.
5.6.6.20. Compare the results obtained with any previously obtained
results. Results must be within the limits mentioned in 6.8 to
6.10.
5.6.7.
Change the air filter on a quarterly basis or depending on the duration
of use of the device:
5.6.7.1.
5.6.7.2.
5.6.7.3.
5.6.7.4.
5.6.7.5.
5.6.7.6.
5.7.
Completely rotate the filter holder anticlockwise.
Pull off the filter holder.
Discard the old air filter.
Place a new air filter into the filter holder.
Place the filter holder back onto the device.
Completely rotate the filter holder clockwise until it stops
turning.
Troubleshooting
Error Message/s
HbA1c result preceded by
[<] or [>]
Cause/s
Concentration is below the
lower limit or above the
upper limit
Albumin and/or Creatinine
result preceded by [<] or
[>]
[CANCELLED: DISCARD
TEST] displayed
Albumin and/or Creatinine
result is under or over range
[DOOR OPEN ERROR
Cartridge compartment door
was opened during a test or
[ESCAPE] button was
pressed
Cartridge compartment door
Page 12 of 43
Solution/s
Report result as being
less than 2.5% HbA1c
- Report result as being
more than 14.0%
HbA1c
N/A
-
Remove cartridge and
repeat test with a new
reagent cartridge
Close door and wait for
UNIVERSITY OF MALTA
FACULTY OF MEDICINE & SURGERY
PHARMACY DEPARTMENT
Ref. No.
SOP/PD/221_02
STANDARD OPERATING PROCEDURE
Valid for:
2 years from
approval
DCA 2000® ANALYSER
CLOSE DOOR] displayed
[OUT OF DATE
CONTROL] displayed
[OUT OF DATE
REAGENT] displayed
[SCAN CALIBRATION
CARD] displayed
was opened while testing was
in progress
Bar code for an expired
control has been read
Bar code for an expired
reagent cartridge has been
read
Calibration card for reagent
cartridge in use was not
scanned
[PLEASE WAIT] to be
displayed
Discard expired control
Discard expired reagent
cartridge
[E-1] displayed
[E-2] displayed
Internal error has occurred
Error detected in the device’s
non-volatile memory
[E-3] displayed
-
Wrong program card
inserted
Check that correct
calibration card is scanned
(check name and lot
number of cartridge in use)
Contact supplier
Switch power switch to the
Off [O] position and
contact supplier
- Insert correct program
card
-
No program card present
-
Insert correct program
card
-
Program card contacts
require cleaning or are
defective
-
-
Wrong program card
inserted
-
Clean contacts with a
pencil eraser and wipe
any left-over particles
with a lint-free tissue.
If problem persists,
contact supplier.
Insert correct program
card
-
Program card is not
completely inserted
-
-
Program card contacts
require cleaning or are
defective
-
[E-4] displayed
[E-5] displayed
Defective program card
Page 13 of 43
Correctly insert
program card
Clean contacts with a
pencil eraser and wipe
any left-over particles
with a lint-free tissue.
If problem persists,
contact supplier
Use a replacement program
card. If problem persists,
contact supplier.
UNIVERSITY OF MALTA
FACULTY OF MEDICINE & SURGERY
PHARMACY DEPARTMENT
Ref. No.
SOP/PD/221_02
STANDARD OPERATING PROCEDURE
Valid for:
2 years from
approval
DCA 2000® ANALYSER
[E-6] displayed
Error in the system timing
[101] or [301] displayed
-
No cartridge is present
-
Optical alignment
problem
Condensation on
cartridge
-
-
Cartridge not inserted
correctly
-
Check that cartridge is
inserted correctly
-
Buffer tab pulled off
prematurely or not pulled
at all
-
Check that buffer tab is
pulled off after
inserting cartridge into
holder
-
Cartridge defect in
optical window or
cartridge optical window
is blocked or dirty
Condensation on
cartridge
-
If problem persists,
contact supplier
-
Allow at least 10
minutes after cartridge
is removed from
refrigerator before
starting test
-
Particulate contamination
-
-
Capillary was not
adequately filled or air
bubble was present
-
If problem persists,
contact supplier
Check that capillary
has no air bubbles
-
Blood dried in capillary
-
[102] or [302] displayed
[103] or [303] displayed
[104] displayed
-
-
Page 14 of 43
Switch power switch to the
Off [O] position and
contact supplier
- Repeat test with
cartridge
-
If problem persists,
contact supplier
Allow at least 10
minutes after cartridge
is removed from
refrigerator before
starting test
No more than 5
minutes should elapse
between filling
capillary and starting
UNIVERSITY OF MALTA
FACULTY OF MEDICINE & SURGERY
PHARMACY DEPARTMENT
Ref. No.
SOP/PD/221_02
STANDARD OPERATING PROCEDURE
Valid for:
2 years from
approval
DCA 2000® ANALYSER
[106] displayed
test
Repeat test with a
capillary holder in
place
-
No capillary holder
inserted
-
-
Controls were improperly
reconstituted
-
Check that the controls
were properly
reconstituted
-
Haemoglobin < 7g/dL
-
Perform test by another
method
-
Buffer tab not pulled or
buffer not released from
tray
Excess blood on capillary
holder
-
Pull buffer tab just
before closing door.
[105] displayed
-
[107] displayed
-
Blood not lysing either
due to an irregularity in
patient’s red blood cells
or because cartridge was
not given enough time to
warm up
-
Haemoglobin > 24g/dL
(patient has abnormally
high Hb or very high
triglycerides)
Particulate contamination
[108], [304], [306] or
[309] displayed
[109], [110], [111] or
[112] displayed
-
Cartridge exposed to
excessive temperature
and/or humidity
[113], [114], [116] or
[313] displayed
-
Cartridge exposed to
excessive temperature
and/or humidity
Page 15 of 43
Check that capillary is
wiped before inserting into
cartridge
- Freeze/thaw sample
before use if patient is
found to have such an
irregularity or else
allow at least 10
minutes after cartridge
is removed from
refrigerator before
starting test
-
Perform test by another
method
If problem persists, contact
supplier
- Check that reagent kits
are being properly
stored
- Open foil package just
prior to using cartridge
- Check that reagent kits
are being properly
stored
UNIVERSITY OF MALTA
FACULTY OF MEDICINE & SURGERY
PHARMACY DEPARTMENT
Ref. No.
SOP/PD/221_02
STANDARD OPERATING PROCEDURE
Valid for:
2 years from
approval
DCA 2000® ANALYSER
-
[115] displayed
[305] displayed
[307], [308], [310] or
[311] displayed
[315] displayed
[316] displayed
Particulate contamination
Open foil package just
prior to using cartridge
-
If problem persists,
contact supplier
Blood was left too long in
No more than 5 minutes
capillary
should elapse between
filling capillary and
starting test
Urine sample turbid or highly - Centrifuge sample
pigmented
before test if sample is
very turbid or cloudy
- Obtain a fresh sample
if sample contains
visible amounts of
blood or is highly
pigmented
Cartridge exposed to
- Check that reagent kits
excessive temperature and/or
are being properly
humidity
stored
- Open foil package just
prior to using cartridge
Device has not been adjusted
to run a Microalbumin /
Creatinine test
- Normalisation cartridge
has not been properly
inserted
Contact supplier
-
Check that cartridge
has been inserted
completely
-
-
If problem persists,
contact supplier
Normalisation cartridge
is dirty or defective
Page 16 of 43
UNIVERSITY OF MALTA
FACULTY OF MEDICINE & SURGERY
PHARMACY DEPARTMENT
Ref. No.
SOP/PD/221_02
STANDARD OPERATING PROCEDURE
DCA 2000® ANALYSER
5.8.
Flow charts
5.8.1.
Set-Up
Start
Place device on a firm, level surface
Check that power switch is set to the
Off (O) position
Insert program card into program card
connector with its label facing upwards
Connect power cord to power
cord connector socket
Plug in power cord to
an electricity outlet
Set power switch to On (I) position
Wait for a few minutes
until device warms up
Press [MENU] button to
access Main Menu
Repeatedly press [NEXT] button to
scroll through the different sub-menus
available
Press [ENTER] button to
Select desired sub-menu
See SOP/PD/221_02/A1 to set-up
each sub-menu
Press [ESCAPE] button to
exit Main Menu
End
Page 17 of 43
Valid for:
2 years from
approval
UNIVERSITY OF MALTA
FACULTY OF MEDICINE & SURGERY
PHARMACY DEPARTMENT
Ref. No.
SOP/PD/221_02
STANDARD OPERATING PROCEDURE
Valid for:
2 years from
approval
DCA 2000® ANALYSER
5.8.2.
Calibration – Calibrating device for HbA1c
Start
Set power switch to On (I) position
Wait for a few minutes
until device warms up
Check that no test is in progress before
attempting to perform a calibration
Locate dot on device next
to bar code track
Locate bar code on calibration card
Hold calibration card in a way
that bar code faces right
Insert calibration card into
bar code track above dot
Hold calibration card against
right side of bar code track
Quickly slide calibration
card past the dot
No
Beep is heard
No
Beep repeatedly fails
to be heard
Repeat procedure
Yes
Yes
1
Contact supplier
Scan was successful
End
Page 18 of 43
1
UNIVERSITY OF MALTA
FACULTY OF MEDICINE & SURGERY
PHARMACY DEPARTMENT
Ref. No.
SOP/PD/221_02
STANDARD OPERATING PROCEDURE
Valid for:
2 years from
approval
DCA 2000® ANALYSER
5.8.3.
Calibration – Calibrating device for Microalbumin / Creatinine
Start
Set power switch to On (I) position
Wait for a few minutes
until device warms up
Check that no test is in progress before
attempting to perform a calibration
Locate dot on device next
To bar code track
Locate bar code on calibration card
Hold calibration card in a way
that bar code faces right
Insert calibration card into
bar code track above dot
Hold calibration card against
right side of bar code track
Quickly slide calibration
card past the dot
No
Beep is heard
No
Beep repeatedly fails
to be heard
Repeat procedure
Yes
Yes
1
Contact supplier
Scan was successful
Repeat procedure using the other
side of calibration card
End
Page 19 of 43
1
UNIVERSITY OF MALTA
FACULTY OF MEDICINE & SURGERY
PHARMACY DEPARTMENT
Ref. No.
SOP/PD/221_02
STANDARD OPERATING PROCEDURE
Valid for:
2 years from
approval
DCA 2000® ANALYSER
5.8.4.
Operation – Performing a Haemoglobin A1c test
Start
Set power switch to On (I) position
Wait for a few minutes
until device warms up
Take out reagent cartridge
pack from refrigerator
Remove reagent cartridge from its foil
package and let it stand for about 5-10
minutes at ambient temperature
Check that capillary holder has an
absorbent pad, a glass capillary and a
properly working latching mechanism
Hold capillary holder at an angle
No
Blood sample obtained
from finger prick
Mix blood sample well
Yes
Touch tip of capillary to blood sample
present on lid of blood collection tube
Touch tip of capillary to a small
drop of blood on the finger
Wipe outside surface of capillary
with lint-free cloth
No
Bubbles present
in capillary
Position capillary holder in
correct orientation for
insertion into reagent cartridge
Discard capillary holder together with
capillary in a biohazard container
Gently insert capillary holder into
reagent cartridge until capillary
holder gently snaps into place
Yes
1
Page 20 of 43
UNIVERSITY OF MALTA
FACULTY OF MEDICINE & SURGERY
PHARMACY DEPARTMENT
Ref. No.
SOP/PD/221_02
STANDARD OPERATING PROCEDURE
Valid for:
2 years from
approval
DCA 2000® ANALYSER
1
Locate dot next to bar code track
Locate bar code on reagent cartridge
Hold reagent cartridge in a way
that bar code faces right
Insert reagent cartridge into
bar code track above dot
Quickly slide reagent cartridge
down past the dot
No
Beep is heard
No
Beep repeatedly fails
to be heard
Repeat procedure
Yes
Yes
3
Contact supplier
Scan was successful
2
Wait for [LOAD CARTRIDGE]
to be displayed
Open cartridge compartment door
Hold reagent cartridge in a way
that bar code faces right
Insert reagent cartridge
into cartridge compartment
Check that reagent cartridge
has snapped into place
Pull flexible plastic pull-tab completely
out of reagent cartridge
4
Page 21 of 43
3
UNIVERSITY OF MALTA
FACULTY OF MEDICINE & SURGERY
PHARMACY DEPARTMENT
Ref. No.
SOP/PD/221_02
STANDARD OPERATING PROCEDURE
Valid for:
2 years from
approval
DCA 2000® ANALYSER
4
Close cartridge compartment door
Wait for 5 seconds for a beep to be
heard to indicate that test has started
No
Wait for test to be performed
Need to cancel test
Yes
Press [ESCAPE] button
More than 15 minutes
has elapsed from when
test was finished
Press [ENTER] button
Yes
Use [MENU] button
(SOP/PD/221_02/A1) to recall test
result
Open cartridge compartment door
Push and hold down with right hand the
button situated on right side
of cartridge compartment
Gently push down with left hand the
plastic tab on reagent cartridge to the
right to release reagent cartridge
Remove reagent cartridge from
cartridge compartment
Discard reagent cartridge
in biohazard container
Set power switch to Off (O) position
2
End
Page 22 of 43
No
Record displayed test result
UNIVERSITY OF MALTA
FACULTY OF MEDICINE & SURGERY
PHARMACY DEPARTMENT
Ref. No.
SOP/PD/221_02
STANDARD OPERATING PROCEDURE
Valid for:
2 years from
approval
DCA 2000® ANALYSER
5.8.5.
Operation – Performing a Microalbumin / Creatinine test
Start
Set power switch to On (I) position
Wait for a few minutes
until device warms up
Take out reagent cartridge
pack from refrigerator
Remove reagent cartridge from its foil
package and let it stand for about 5-10
minutes at ambient temperature
Check that capillary holder has an
absorbent pad, a glass capillary, a
properly working latching mechanism
and a starch plug that is not situated at
the bottom of capillary tube
Immerse tip of capillary tube in urine
sample to a level just above the
capillary starch plug
Allow enough time for urine sample to
flow up the capillary tube and come
into contact with starch plug
Remove capillary tube
from urine sample
Urine flowed back
down capillary tube
No
Wipe outside surface of capillary
with lint-free cloth
Yes
No
Bubbles present
in capillary
Position capillary holder in
correct orientation for
insertion into reagent cartridge
Discard capillary holder together with
capillary in a biohazard container
Gently insert capillary holder into
reagent cartridge until capillary
holder gently snaps into place
Re-immerse capillary
tube in urine sample
Yes
Page 23 of 43
1
UNIVERSITY OF MALTA
FACULTY OF MEDICINE & SURGERY
PHARMACY DEPARTMENT
Ref. No.
SOP/PD/221_02
STANDARD OPERATING PROCEDURE
Valid for:
2 years from
approval
DCA 2000® ANALYSER
1
Locate dot next to bar code track
Locate bar code on reagent cartridge
Hold reagent cartridge in a way
that bar code faces right
Insert reagent cartridge into
bar code track above dot
Quickly slide reagent cartridge
down past the dot
No
Beep is heard
No
Beep repeatedly fails
to be heard
Repeat procedure
Yes
Yes
3
Contact supplier
Scan was successful
2
Wait for [LOAD CARTRDIGE, INSERT
PLUNGER] to be displayed
Open cartridge compartment door
Hold reagent cartridge in a way
that bar code faces right
Insert reagent cartridge
into cartridge compartment
Check that cartridge has
snapped into place
Insert plunger into hole found in the top
of the capillary holder
Fully depress plunger into capillary
holder to lock it in place
4
Page 24 of 43
3
UNIVERSITY OF MALTA
FACULTY OF MEDICINE & SURGERY
PHARMACY DEPARTMENT
Ref. No.
SOP/PD/221_02
STANDARD OPERATING PROCEDURE
Valid for:
2 years from
approval
DCA 2000® ANALYSER
4
Press [ENTER] button
Pull flexible plastic pull-tab completely
out of reagent cartridge
Close cartridge compartment door
Wait for 5 seconds for a beep to be
heard to indicate that test has started
No
Need to cancel test
Wait for test to be performed
Yes
Press [ESCAPE] button
More than 15 minutes
has elapsed from when
test was finished
Press [ENTER] button
Yes
Use [MENU] button (SOP/PD/221_02/A1)
to recall test result
Open cartridge compartment door
Push and hold down with right hand the
button situated on right side
of cartridge compartment
Gently push down with left hand the plastic
tab on reagent cartridge to the right to
release reagent cartridge
Remove reagent cartridge from cartridge
compartment
Discard reagent cartridge
in biohazard container
2
Set power switch to Off (O) position
End
Page 25 of 43
No
Record displayed test result for albumin,
creatinine and albumin/creatinine ratio
UNIVERSITY OF MALTA
FACULTY OF MEDICINE & SURGERY
PHARMACY DEPARTMENT
Ref. No.
SOP/PD/221_02
STANDARD OPERATING PROCEDURE
DCA 2000® ANALYSER
5.8.6.
Valid for:
2 years from
approval
Quality Control – Analysing control for Haemoglobin A1c
Start
Set power switch to On (I) position
Wait for a few minutes
until device warms up
Remove 2 HbA1c control vials and a
reagent cartridge from refrigerator
Reconstitute lyophilised controls
using solvent provided
Remove reagent cartridge from its foil
package and let it stand for about 5-10
minutes at ambient temperature
4
Check that capillary holder has an
absorbent pad, a glass capillary and a
properly working latching mechanism
Locate dot next to bar
code track on device
Choose correct side of control
card according to control
solution to be used first
Locate bar code on control card
Hold control card in a way
that bar code faces right
Insert and hold gently the control
card against right side of bar
code track above the dot
1
Page 26 of 43
UNIVERSITY OF MALTA
FACULTY OF MEDICINE & SURGERY
PHARMACY DEPARTMENT
Ref. No.
SOP/PD/221_02
STANDARD OPERATING PROCEDURE
Valid for:
2 years from
approval
DCA 2000® ANALYSER
1
Quickly slide control card
down past the dot
No
Beep is heard
No
Beep repeatedly fails
to be heard
Repeat procedure
Yes
Yes
3
Contact supplier
Scan was successful
2
Press [ENTER] button
Hold capillary holder at an angle
Mix well contents of control solution
Touch tip of capillary to control solution
Wipe outside surface of capillary
with lint-free cloth
Bubbles present
in capillary
No
Position capillary holder in
correct orientation for
insertion into reagent cartridge
Yes
Discard capillary holder together with
capillary in a biohazard container
Gently insert capillary holder into
reagent cartridge until capillary
holder gently snaps into place
4
Locate dot next to bar code track
Locate bar code on reagent cartridge
Hold reagent cartridge in a way
that bar code faces right
5
Page 27 of 43
3
UNIVERSITY OF MALTA
FACULTY OF MEDICINE & SURGERY
PHARMACY DEPARTMENT
Ref. No.
SOP/PD/221_02
STANDARD OPERATING PROCEDURE
Valid for:
2 years from
approval
DCA 2000® ANALYSER
5
Insert reagent cartridge into
bar code track above dot
Quickly slide reagent cartridge
down past the dot
No
Beep is heard
Repeat procedure
Scan was successful
Beep repeatedly fails
to be heard
Yes
6
No
6
Yes
Wait for [LOAD CONTROL]
to be displayed
Contact supplier
Close cartridge compartment door
2
Hold reagent cartridge in a way
that bar code faces right
Insert reagent cartridge
into cartridge compartment
Check that cartridge has
snapped into place
Pull flexible plastic pull-tab completely
out of reagent cartridge
Close cartridge compartment door
No
Wait for test to be performed
Need to cancel test
Yes
No
Press [ESCAPE] button
[CONTROL OUT OF
RANGE] is displayed
Press [ENTER] button
Yes
7
8
Page 28 of 43
9
UNIVERSITY OF MALTA
FACULTY OF MEDICINE & SURGERY
PHARMACY DEPARTMENT
Ref. No.
SOP/PD/221_02
STANDARD OPERATING PROCEDURE
DCA 2000® ANALYSER
Valid for:
2 years from
approval
9
8
No
More than 15 minutes
has elapsed from when
test was finished
Press [ESCAPE] button to display
out-of-range control
Record displayed result and compare it
with result range present in package
insert of control solution
Yes
Use [MENU] button
(SOP/PD/221_02/A1) to recall test
result
7
Open cartridge compartment door
Push and hold down with right hand the
button situated on right side
of cartridge compartment
Gently push down with left hand the
plastic tab on reagent cartridge to the
right to release reagent cartridge
Remove reagent cartridge from
cartridge compartment
Discard reagent cartridge
in biohazard container
Repeat whole procedure using
the second control solution
Set power switch to Off (O) position
2
End
Page 29 of 43
UNIVERSITY OF MALTA
FACULTY OF MEDICINE & SURGERY
PHARMACY DEPARTMENT
Ref. No.
SOP/PD/221_02
STANDARD OPERATING PROCEDURE
DCA 2000® ANALYSER
5.8.7.
Valid for:
2 years from
approval
Quality Control – Analysing control for Microalbumin /
Creatinine
Start
Set power switch to On (I) position
Wait for a few minutes
until device warms up
Remove the 2 Microalbumin /
Creatinine control vials and a reagent
cartridge from refrigerator
Reconstitute lyophilised controls
using solvent provided
Remove reagent cartridge from its foil
package and let it stand for about 5-10
minutes at ambient temperature
4
Check that capillary holder to be used
has an absorbent pad, a glass capillary,
a properly working latching mechanism
and a starch plug that is not situated at
the bottom of capillary tube
Locate dot next to bar code track
Choose correct side of control
card according to control
solution to be used first
Locate bar code on control card
Hold control card in a way
that bar code faces right
Insert and hold gently control
card against right side of bar
code track above dot
1
Page 30 of 43
UNIVERSITY OF MALTA
FACULTY OF MEDICINE & SURGERY
PHARMACY DEPARTMENT
Ref. No.
SOP/PD/221_02
STANDARD OPERATING PROCEDURE
DCA 2000® ANALYSER
Valid for:
2 years from
approval
1
Quickly slide control
card down past dot
No
Beep is heard
Repeat procedure
Scan was successful
Beep repeatedly fails
to be heard
Yes
3
No
Yes
Press [ENTER] button
Contact supplier
Hold capillary holder at an angle
2
Mix well contents of control solution
Touch tip of capillary
to control solution
Wipe outside surface of capillary
with a lint-free tissue
No
Bubbles present
in capillary
Position capillary holder in correct
orientation for insertion
into reagent cartridge
Discard capillary holder
together with capillary
Gently insert capillary holder into
reagent cartridge until capillary holder
gently snaps into place
Yes
4
Locate dot next to bar code track
Locate bar code on reagent cartridge
Hold reagent cartridge in a way
that bar code faces right
5
Page 31 of 43
3
UNIVERSITY OF MALTA
FACULTY OF MEDICINE & SURGERY
PHARMACY DEPARTMENT
Ref. No.
SOP/PD/221_02
STANDARD OPERATING PROCEDURE
Valid for:
2 years from
approval
DCA 2000® ANALYSER
5
Insert reagent cartridge into
bar code track above dot
Quickly slide reagent
cartridge past the dot
No
No
Beep repeatedly fails
to be heard
Beep is heard
Yes
Yes
6
Contact supplier
Scan was successful
2
Wait for [LOAD CARTRIDGE, INSERT
PLUNGER] to be displayed
Open cartridge compartment door
Hold reagent cartridge in a way
that bar code faces right
Insert reagent cartridge into
cartridge compartment
Check that cartridge has
snapped into place
Insert plunger into hole found in
the top of capillary holder
Fully depress plunger into capillary
holder to lock it in place
Press [ENTER] button
Pull flexible pull-tab completely
out of reagent cartridge
Close cartridge compartment door
7
Page 32 of 43
6
UNIVERSITY OF MALTA
FACULTY OF MEDICINE & SURGERY
PHARMACY DEPARTMENT
Ref. No.
SOP/PD/221_02
STANDARD OPERATING PROCEDURE
Valid for:
2 years from
approval
DCA 2000® ANALYSER
7
No
Test needs to be
cancelled
Wait for test to be performed
Press [ESCAPE] button
[CONTROL OUT OF
RANGE] displayed
Yes
No
More than 15 minutes
has elapsed from when
test was finished
Yes
Press [ENTER] button
Yes
Press [ESCAPE] button to display result
Use [MENU] button
(SOP/PD/221_02/A1) to recall result
Record displayed result and compare it
with result range present in package
insert of control solution
Open cartridge compartment door
Push and hold down with right hand
the button on right side
of cartridge compartment
Gently push with left hand the
plastic tab on cartridge to the right
to release reagent cartridge
Remove reagent cartridge from
cartridge compartment
Discard reagent cartridge
in a biohazard container
Repeat whole procedure using
the second control solution
Set power switch to Off (O) position
2
End
Page 33 of 43
No
UNIVERSITY OF MALTA
FACULTY OF MEDICINE & SURGERY
PHARMACY DEPARTMENT
Ref. No.
SOP/PD/221_02
STANDARD OPERATING PROCEDURE
Valid for:
2 years from
approval
DCA 2000® ANALYSER
5.8.8.
Maintenance
1
Start
No
Need to clean
outside surface
Need to clean
cartridge
compartment
Yes
Yes
Check that device is switched Off
Check that device is switched Off
Clean with a moist lint-free cloth
Open cartridge compartment
door as far as possible
No
Blood present on
exterior surface
Allow device to completely dry before
attempting to switch it On
Clean inside surface with
a moist lint-free cloth
Yes
1
Expose exterior surface to either
0.5% sodium hypochlorite or 2%
glutaraldehyde solution for 10 minutes
Dry inside surface with
a dry lint-free cloth
Locate cartridge return spring containing
two holes at its periphery
Insert tip of straightened paper
clip into top hole of spring
Gently pull this end of spring towards
centre of cartridge compartment to
release one side of the spring
Insert tip of straightened paper
clip into bottom hole of spring
Gently pull this end of spring towards
centre of cartridge compartment to
release other side of the spring
Pull cartridge return spring completely
out of cartridge compartment
Page 34 of 43
3
No
2
UNIVERSITY OF MALTA
FACULTY OF MEDICINE & SURGERY
PHARMACY DEPARTMENT
Ref. No.
SOP/PD/221_02
STANDARD OPERATING PROCEDURE
DCA 2000® ANALYSER
3
Clean cartridge return spring
with a moist lint-free cloth
Dry cartridge return spring
with a dry lint-free cloth
Remove any spilled liquid from cartridge
holder using a clean, dry sponge swab
provided in Cleaning Kit
Rotate cartridge holder while cartridge
compartment door is partially closed to
locate and remove any additional liquid
that might still be present
Clean cartridge compartment holder
with a moist sponge swab and
rotate holder as necessary
Locate vertical grooves and front and
back slots inside cartridge compartment
Locate leaf spring on one side
of cartridge return spring
Orient leaf spring towards back of device
Hold cartridge return spring from
both sides near the holes
Pinch both sides of cartridge return spring
and lower it into device by sliding the
sides of the spring between the vertical
grooves in compartment
4
Page 35 of 43
Valid for:
2 years from
approval
UNIVERSITY OF MALTA
FACULTY OF MEDICINE & SURGERY
PHARMACY DEPARTMENT
Ref. No.
SOP/PD/221_02
STANDARD OPERATING PROCEDURE
Valid for:
2 years from
approval
DCA 2000® ANALYSER
4
Check that cartridge return spring
can freely slide up and down
within cartridge compartment
Gently push down one edge of cartridge
return spring and insert it into slot
Gently push down opposite edge of
cartridge return spring into other slot
2
No
Check that leaf spring of cartridge return
spring is oriented towards back of device
Need to perform an
optical test
5
Yes
Check that cartridge return spring is
securely attached via the grooves
of cartridge compartment
Locate bar code on optical test cartridge
Hold optical test cartridge in a
way that bar code faces right
Insert optical test cartridge into bar
code track above dot of device
Quickly slide cartridge down past dot
No
Beep is heard
Repeat procedure
Scan was successful
Beep repeatedly fails
to be heard
Yes
No
Yes
Contact supplier
6
Page 36 of 43
UNIVERSITY OF MALTA
FACULTY OF MEDICINE & SURGERY
PHARMACY DEPARTMENT
Ref. No.
SOP/PD/221_02
STANDARD OPERATING PROCEDURE
DCA 2000® ANALYSER
6
Press [ENTER] button when [RUN
STANDARD 1] is displayed
Open cartridge compartment door
Hold optical test cartridge in a
way that bar code faces right
Insert optical test cartridge
into cartridge compartment
Check that optical test cartridge
has snapped into place
Close cartridge compartment door
Wait for 6 minutes for
test to be performed
Record displayed result
for transmittance, standard
deviation and drift
Open cartridge compartment door
Push and hold down with right hand
the button situated on right side
of cartridge compartment
Gently push plastic tab on cartridge
to the right with left hand to release
optical test cartridge
Pull optical test cartridge out
of cartridge compartment
7
Page 37 of 43
Valid for:
2 years from
approval
UNIVERSITY OF MALTA
FACULTY OF MEDICINE & SURGERY
PHARMACY DEPARTMENT
Ref. No.
SOP/PD/221_02
STANDARD OPERATING PROCEDURE
DCA 2000® ANALYSER
7
Compare results with any previously
obtained results. Results must be within
limits mentioned in precautions section
No
Need to change
air filter
5
Yes
Completely rotate filter
holder anticlockwise
Pull off filter holder
Discard old filter
Place new air filter into filter holder
Place filter holder back onto device
Completely rotate filter holder
clockwise until it stops turning
End
Page 38 of 43
Valid for:
2 years from
approval
UNIVERSITY OF MALTA
FACULTY OF MEDICINE & SURGERY
PHARMACY DEPARTMENT
Ref. No.
SOP/PD/221_02
STANDARD OPERATING PROCEDURE
DCA 2000® ANALYSER
Valid for:
2 years from
approval
6. Precautions
6.1.
6.2.
6.3.
6.4.
6.5.
6.6.
6.7.
6.8.
6.9.
6.10.
6.11.
6.12.
6.13.
6.14.
Do not expose the device to extremes of temperature and humidity, direct
sunlight or air current.
Do not block the ventilation panels found on the back and right side of the
device.
When performing an HbA1c test, the device should be at an ambient
temperature of 15-32oC.
When performing a Microalbumin / Creatinine test, the device should be at an
ambient temperature of 18-30oC.
Do not use normal cotton swabs to clean the cartridge holder since any cotton
fibres left can interfere with the optical system of the device.
Do not allow any liquid to spill into the device whilst cleaning the cartridge
holder since this can interfere with the optical system.
The mean transmittance of the optical system should be within the range of
0.9500 to 1.0500, and should not vary by more than /- 0.01000.
The standard deviation of the optical system should be less than 0.00150.
The drift of the optical system should be less than 0.01400.
Ensure that the program card is never inserted while the power switch is in the
On [I] position since this can damage the card.
Calibrate the device each time a new lot number of reagent cartridges are to be
used.
Do not use scissors to open a reagent pack since this could damage the reagent
or its plastic pull-tab.
When handling a reagent cartridge, do not touch its optical window since this
can lead to erroneous results.
Do not use a reagent cartridge if:
6.14.1.
6.14.2.
6.14.3.
6.14.4.
Physically damaged
Flexible plastic pull-tab is loose or missing
Desiccant sack is missing
Desiccant particles are found loose inside the package
6.15. Do not allow blood or urine to make contact with any of the plastic parts of the
capillary holder.
6.16. When using a blood sample obtained from a venipuncture, do not attempt to
fill the capillary by touching it to the blood in the collection tube since this will
most often lead to the contamination of the capillary holder.
6.17. When wiping the outside surface of the capillary, do not allow the tissue to
touch its open end since this could result in loss of sample.
6.18. Once the capillary is filled with the sample, analysis must begin within 5
minutes.
Page 39 of 43
UNIVERSITY OF MALTA
FACULTY OF MEDICINE & SURGERY
PHARMACY DEPARTMENT
Ref. No.
SOP/PD/221_02
STANDARD OPERATING PROCEDURE
DCA 2000® ANALYSER
Valid for:
2 years from
approval
6.19. Run a quality control test:
6.19.1.
6.19.2.
6.19.3.
6.19.4.
For each new lot of reagent kits
After calibration
To help train new analysts
When results do not coincide with the patient’s clinical signs or
symptoms.
7. References
Bayer Corporation. DCA 2000 Analyser Operating Manual. USA: Bayer
Corporation; 1997.
Mosby’s dictionary of medicine, nursing and health professions. 7th ed. USA: Mosby
Elsevier; 2006. Venipuncture; p. 1948.
8. Appendices
SOP/PD/221_02/A1 – Set-Up Menu Table
SOP/PD/221_02/A2 – General Set-Up Sub-Menu Table
9. Revision History
Version Number
01
02
Amendments/ Reasons for change
Initial Release
Inclusion of subheading titles of
Procedure section in Table of Contents
Standardisation of text when referring to
appendices and updating version number
Page 40 of 43
UNIVERSITY OF MALTA
FACULTY OF MEDICINE & SURGERY
PHARMACY DEPARTMENT
Ref. No.
SOP/PD/221_02
STANDARD OPERATING PROCEDURE
DCA 2000® ANALYSER
Valid for:
2 years from
approval
SOP/PD/221_02/A1 – Set Up Menu Table
Sub-Menu
Function
-
To recall the latest 16
RECALL
PREVIOUS TESTS? test results
-
SET SEQUENCE
NUMBER?
An optional function
that allows the user to
develop a numbering
system for the test
results
-
RECALL
CONTROL
RESULTS?
To recall the latest 16
control test results
VIEW
CALIBRATION
STATUS?
To recall the latest 2
calibration statuses for
each reagent test
-
-
-
SET DATE/TIME?
To set the date and
time
-
-
Page 41 of 43
Set-Up
Repeatedly press [NEXT] button to
scroll through the latest 16 test
results
Press [ESCAPE] button
Press Up or Down arrow buttons
to select a number for the first
digit.
Press [NEXT] button to move the
cursor to the next digit
Repeat previous steps to select a
number for second and third digit
Press [ENTER] button to confirm
sequence number
Press [ESCAPE] button
Repeatedly press [NEXT] button to
scroll through the latest 16 control
test results
Press [ESCAPE] button
Repeatedly press [NEXT] button to
recall the status of each calibration
record
Press [ESCAPE] button
Repeatedly press Up and Down
arrow buttons until desired day is
displayed
Press [NEXT] button
Repeatedly press Up and Down
arrow buttons until the desired
number of the month is displayed
Press [NEXT] button
Repeatedly press Up and Down
arrow buttons until the desired
year is displayed
Press [NEXT] button
Repeatedly press Up and Down
arrow buttons until desired hour is
displayed
Press [NEXT] button
Repeatedly press Up and Down
UNIVERSITY OF MALTA
FACULTY OF MEDICINE & SURGERY
PHARMACY DEPARTMENT
Ref. No.
SOP/PD/221_02
STANDARD OPERATING PROCEDURE
DCA 2000® ANALYSER
INSTRUMENT
SETUP?
To set-up the device
with respect to Time
Format (T), Date
Format (D), Labels
displayed with results
(L), Controls (C) and
Computer Port
Configuration (P)
SET CREATININE
UNITS?
To select between
‘mg/dL’ or ‘mmol/L’
INSTRUMENT
SETUP?
RUN CONTROL?
To determine any
existing problems
with keyboard,
display, bar code
reader, printer port,
memory and computer
port functions
To set a desired
control number before
attempting to start a
control test
Valid for:
2 years from
approval
arrow buttons until desired minute
is displayed
- Press [ENTER] button if a 24 hr
format time is selected
- Press [NEXT] button and then Up
or Down arrow button if an
AM/PM format time is selected.
Press [ENTER] button.
- Repeatedly press [NEXT] button
until cursor is displayed beneath
the desired letter abbreviation
- Press Up or Down arrow button to
scroll through the different
numbers (each number represents
a setting, see SOP/PD/221_02/A2)
- Press [NEXT] button to move the
cursor to the next letter
abbreviation
- Press [ESCAPE] button when
finished from this sub-menu
- Press Up or Down arrow buttons
to select between [mg/dL] and
[mmol/L]
- Press [ENTER] button to confirm
- Press [ESCAPE] button
To be used only by authorised supplier
Available only if selected previously
in the INSTRUMENT SETUP submenu (when control is different from a
DCA 2000)
Page 42 of 43
UNIVERSITY OF MALTA
FACULTY OF MEDICINE & SURGERY
PHARMACY DEPARTMENT
Ref. No.
SOP/PD/221_02
STANDARD OPERATING PROCEDURE
DCA 2000® ANALYSER
Valid for:
2 years from
approval
SOP/PD/221_02/A2 – General Set Up Sub-Menu Table
General Set-Up
Setting Number
1
Setting Definition
AM/PM
T – TIME FORMAT
D – DATE FORMAT
L – Labels displayed
with results
2
1
24 hour format
Month/Day/Year
2
Day/Month/Year
3
0
Year/Month/Day
No labels
1
Sequence number that
resets daily
2
Continuous sequence
number
3
Time assay began
4
Time assay began;
sequence number that
resets daily
5
Time assay began;
continuous sequence
number
Only DCA controls are
used
0
C – CONTROLS
P – Computer Port
Configuration
1
0
Any other control can be
used
Computer port is OFF
2
Computer port is ON
Page 43 of 43