UNIVERSITY OF MALTA
FACULTY OF MEDICINE & SURGERY
PHARMACY DEPARTMENT
Ref. No.
SOP/PD/213_02
STANDARD OPERATING PROCEDURE
COAGUCHEK® S
Page 1 of 17
Valid for:
2 years from
approval
UNIVERSITY OF MALTA
FACULTY OF MEDICINE & SURGERY
PHARMACY DEPARTMENT
Ref. No.
SOP/PD/213_02
STANDARD OPERATING PROCEDURE
COAGUCHEK® S
Valid for:
2 years from
approval
1. Scope
This Standard Operating Procedure (SOP) applies to the staff and students
using the CoaguChek® S in the Pharmacy Practice Resource Unit (PPRU) at
the Pharmacy Department, University of Malta.
2. Objective
To describe the procedure for the configuration, operation, quality control,
maintenance and troubleshooting of the CoaguChek® S.
3. Definitions
3.1.
Check Display Function: To regularly check that all segments of the
monitor display are functioning correctly.
3.2.
CoaguChek® S: A point-of-care testing device used to quantitatively
determine prothrombin time using capillary blood from a fingertip or
untreated venous whole blood.
3.3.
CoaguChek® PT Test Strips: Contain a number of reagents together
with iron oxide particles which move in response to an oscillating
magnetic field. When the sample of blood is applied and coagulation
starts to take place, the movement of these iron oxide particles becomes
impeded, converting the time it takes for this to occur into a result. The
valid measuring ranges for the strips are 0.6-8.0 for INR, 70-5 for %Q
(quick percentage value), 9.6-33.9 for Sec (seconds) and 0.8-2.8 for
PTR (prothrombin ratio). Test strips must be stored in a refrigerator.
3.4.
Code Chip: Provides the device with important information about the
test method, the lot number and the expiry date of the test strips being
used. Each pack of test strips comes with a new code chip that should
be inserted into the device as soon as the new pack of strips is to be
used.
3.5.
Code Chip Slot [I]: The area in which the code chip is inserted.
3.6.
Data Port [J]: Permits the transfer of stored data through a printer or
another form of data transfer.
3.7.
Display Screen [A]: Displays the results and information icons.
Page 2 of 17
UNIVERSITY OF MALTA
FACULTY OF MEDICINE & SURGERY
PHARMACY DEPARTMENT
Ref. No.
SOP/PD/213_02
STANDARD OPERATING PROCEDURE
COAGUCHEK® S
Valid for:
2 years from
approval
3.8.
Mains Adapter Connection Port [H]: The area which enables
connection of the mains adapter to the device.
3.9.
Mem Button [C]: To recall results from memory and to change the
device settings in Set Mode.
3.10. Memory: Saves the latest 60 readings in chronological order, with the
latest result displayed first, together with the relevant time and date. A
letter “C” next to a reading stored in memory indicates that it is a result
of a quality control test procedure.
3.11. On/Off Button [B]: To turn the device On or Off.
3.12. Sample Application Area [E]: The area where the sample of blood is
placed when a test strip is inserted into the test strip guide.
3.13. Set Button [G]: To set the various monitor configuration parameters.
3.14. Set Mode: Allows the device to be set according to the user’s
preferences (see SOP/PD/213_01/A1).
3.15. Test Chamber Flap [F]: To be lifted to allow cleaning of the
measurement chamber.
3.16. Test Strip Guide [D]: The area in which the test strip is inserted.
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.
Page 3 of 17
UNIVERSITY OF MALTA
FACULTY OF MEDICINE & SURGERY
PHARMACY DEPARTMENT
Ref. No.
SOP/PD/213_02
STANDARD OPERATING PROCEDURE
Valid for:
2 years from
approval
COAGUCHEK® S
5. Procedure
5.1.
Diagram of CoaguChek® S
H
A
J
G
F
B
I
C
E
D
5.2.
Configuration
5.2.1.
5.2.2.
5.2.3.
5.2.4.
5.2.5.
5.2.6.
5.2.7.
5.2.8.
5.2.9.
Insert batteries accordingly into the battery compartment, if
using the device in battery mode.
Attach the mains adapter to the mains adapter connection port
[H], if using the device with an electricity supply.
Plug in the mains adapter to an appropriate electricity socket, if
using the device with an electricity supply.
Check that the device is switched Off before inserting the code
chip.
Check that the number on the code chip to be inserted
corresponds to the 3 digits which follow the word “LOT” on the
foil pouches containing the test strips.
Slide the code chip into the code chip slot [I], with the side
showing the code number facing towards the user, until it snaps
into place.
Press and hold the On/Off button to make use of the “Check
Display” function.
Release the On/Off button to exit the “Check Display” function.
Check that the displayed code chip number corresponds to the 3
digits which follow the word “LOT” on the foil pouches
containing the test strips.
Page 4 of 17
UNIVERSITY OF MALTA
FACULTY OF MEDICINE & SURGERY
PHARMACY DEPARTMENT
Ref. No.
SOP/PD/213_02
STANDARD OPERATING PROCEDURE
COAGUCHEK® S
Valid for:
2 years from
approval
5.2.10. Wait until a flashing test strip is displayed.
5.2.11. Press the Set button [G] to enter Set Mode.
5.2.12. Repeatedly press the Set button to scroll between the different
configuration parameters available in Set Mode (see
SOP/PD/213_02/A1).
5.2.13. Press the M button to change the setting that is currently
flashing.
5.2.14. Repeatedly press the M button until the desired setting is
displayed.
5.2.15. Press the Set button to confirm the selected setting.
5.2.16. Press the On/Off button to switch the device Off.
5.3.
Operation
5.3.1.
5.3.2.
5.3.3.
5.3.4.
5.3.5.
5.3.6.
5.3.7.
5.3.8.
5.3.9.
5.3.10.
5.3.11.
5.3.12.
5.3.13.
5.3.14.
5.3.15.
5.3.16.
5.3.17.
Take out one test strip foil pouch from the refrigerator.
Wait at least 5 minutes for the foil pouch to reach room
temperature.
Place the device on a level stable surface or hold it in such a
way as to be roughly in a horizontal position.
Press the On/Off button to switch the device On.
Check that the displayed code chip number corresponds to the 3
digits which follow the word “LOT” on the foil pouch.
Wait until a flashing test strip symbol is displayed.
Open the foil pouch and take out the test strip.
Insert the test strip into the test strip guide [D] in the direction
of the arrows on the end of the test strip.
Slide the test strip in as far as it will go.
Check that the lettering “PT” is still visible after the test strip
has been inserted.
Wait for about 45 seconds until the test strip is warmed up to a
preset temperature.
Wait until a blood drop icon starts flashing to indicate that the
device is ready to perform a test. A blood drop must now be
applied to the test strip in 180 seconds.
Apply the first drop of blood directly to the sample application
area of the test strip which is flashing yellow.
Wait until the result is displayed. Result is automatically stored
in memory.
If result is displayed in INR and an Up (too high) or Down (too
low) arrow is displayed, this indicates that the value is outside
the defined target range.
Take out the test strip from the device.
Press the On/Off button to switch the device Off.
Page 5 of 17
UNIVERSITY OF MALTA
FACULTY OF MEDICINE & SURGERY
PHARMACY DEPARTMENT
Ref. No.
SOP/PD/213_02
STANDARD OPERATING PROCEDURE
COAGUCHEK® S
Valid for:
2 years from
approval
5.3.18. Slide the used lancet and test strip into the open foil pouch and
discard in the sharps container.
5.3.19. Accessing Memory
5.3.19.1.
5.3.19.2.
5.3.19.3.
5.3.19.4.
5.4.
Press the On/Off button to switch the device On.
Wait until the flashing test strip icon is displayed.
Press the Mem button.
Repeatedly press the Mem button to scroll through
the different readings stored in memory.
Quality Control
5.4.1.
5.4.2.
5.4.3.
5.4.4.
5.4.5.
5.4.6.
5.4.7.
5.4.8.
5.4.9.
5.4.10.
5.4.11.
5.4.12.
5.4.13.
5.4.14.
5.4.15.
5.4.16.
5.4.17.
Take one test strip and one vial of control solution out of the
refrigerator.
Wait at least 5 minutes until both items reach room
temperature.
Pull the small tab to remove the blue sealing foil from the vial.
Hold the vial in a vertical position.
Tap the bottom of the vial hard against a steady surface so that
the glass capsule inside the vial sinks to the bottom.
Wrap the vial in a cloth and squeeze the bottom half of the vial
firmly between the index finger and thumb to break the inner
glass capsule.
Start timing 2 minutes when this glass capsule is broken.
Raise arm to shoulder level and strike the vial hard against the
table top to mix the control solution.
Repeat 5.4.8 ten times.
Leave the vial lying on a steady surface for the rest of the 2
minutes.
Press the On/Off button to switch the device On.
Wait until a flashing test strip icon is displayed.
Insert the test strip into the device and push it firmly inside.
Wait for approximately 45 seconds until the test strip is
warmed up to a preset temperature.
Wait until a flashing blood drop sign is displayed to apply the
control solution. A drop of the control solution must now be
applied to the test strip in 180 seconds.
Shake the contents of the vial vigorously in the direction of the
cap.
Turn the cap gently and pull it off while the dropper part of the
vial is pointing downwards.
Page 6 of 17
UNIVERSITY OF MALTA
FACULTY OF MEDICINE & SURGERY
PHARMACY DEPARTMENT
Ref. No.
SOP/PD/213_02
STANDARD OPERATING PROCEDURE
COAGUCHEK® S
Valid for:
2 years from
approval
5.4.18. Squeeze the first drop of control solution into the cap and
discard.
5.4.19. Apply the second drop to the flashing yellow application area
on the test strip.
5.4.20. Check that no air bubbles are present.
5.4.21. Wait for about 1 minute until the result is displayed together
with a [c] adjacent to it. The device will automatically save the
result in memory.
5.4.22. Compare the result obtained with the control range specified in
the control value sheet that is supplied with the control solution.
The device is functioning correctly if the measured value is
within the specified control range.
5.4.23. Contact the supplier for further instructions if the measured
value is outside the specified control range.
5.5.
Maintenance
5.5.1.
5.5.2.
5.5.3.
5.5.4.
5.5.5.
Check that the device is switched Off before performing any
maintenance procedures.
Replace all 4 batteries (1.5V AA LR6) or use the device with
the mains adapter if the battery icon is flashing.
Clean the outside of the device with a moistened lint-free swab.
Dry the outside of the device with a lint-free swab
Clean the measurement chamber if a hand icon is displayed on
switching on the device.
5.5.5.1.
5.5.5.2.
5.5.5.3.
5.5.5.4.
5.5.5.5.
5.5.5.6.
Check that the device is switched Off.
Lift the measurement chamber flap until it is fully
open.
Clean the test strip guide and the underside of the
flap with a slightly moistened cotton bud.
Dry the test strip guide and the underside of the flap
with a lint-free swab.
Leave the measurement chamber open for 10
minutes to dry properly before closing the flap.
Close the measurement chamber flap.
Page 7 of 17
UNIVERSITY OF MALTA
FACULTY OF MEDICINE & SURGERY
PHARMACY DEPARTMENT
Ref. No.
SOP/PD/213_02
STANDARD OPERATING PROCEDURE
COAGUCHEK® S
5.6.
Valid for:
2 years from
approval
Troubleshooting
Error
[ERROR] [CODE]
flashing
Cause/s
Code chip is damaged or not
inserted correctly
Solution/s
Switch device Off, remove
code chip and re-insert code
chip again. If message reappears contact supplier.
[ERROR] [CODE]
and test strip icon
flashing
Code chip does not
correspond to the used test
strip in device
Switch device Off and insert
the correct code chip that
corresponds with the test strip
that is being used
[CODE] flashing and
[- - -] displayed
Code chip is missing or has
not been inserted correctly
[ERROR] test strip
icon flashing
N/A
Switch device Off and reinsert code chip into its slot
until it engages accordingly
Repeat test using a new test
strip and blood taken from a
new puncture site of a
different fingertip
[ERROR] crossed
blood drop icon
flashing
Not enough blood present on
test strip
[ERROR] hand icon
flashing
[ERROR]
temperature icon
flashing
Measurement chamber needs
cleaning
Device is too hot or too cold
to perform measurements
correctly
[ERROR] light icon
flashing
Environment is too bright
and light is entering
measurement chamber
Technical fault/s
[ERROR] phone icon
flashing
Page 8 of 17
Repeat test using a new test
strip and blood taken from a
new puncture site of a
different fingertip
Clean measurement chamber
(see section 5.5.5)
Switch device Off and allow it
to stand at room temperature
for 30 minutes (open
measurement chamber flap to
enable device to reach room
temperature more rapidly)
Switch device Off and operate
it in a less bright location
Check that no test strip is
present in device when this is
switched On. Switch monitor
Off and On again.
UNIVERSITY OF MALTA
FACULTY OF MEDICINE & SURGERY
PHARMACY DEPARTMENT
Ref. No.
SOP/PD/213_02
STANDARD OPERATING PROCEDURE
COAGUCHEK® S
5.7.
Flow Charts
5.7.1.
Configuration
Start
No
Using device in
battery mode
Attach mains adapter to mains
adapter connection port [H]
Insert batteries accordingly
Plug in mains adapter to an
appropriate electricity socket
Yes
Check that device is switched Off
before code chip is inserted
Check that number on
code chip to be inserted corresponds to
the 3 digits which follow the word
“LOT” on foil pouches of test strips
Slide code chip into code chip slot [I]
until it snaps into place
Press and hold On/Off button to use the
“Check Display” function
Release On/Off button to exit the
“Check Display” function
Check that displayed code chip
number corresponds to the 3 digits
which follow the word “LOT” on foil
pouches of test strips
Wait until a flashing test
strip icon is displayed
Press Set button [G] to enter Set mode
1
Page 9 of 17
Valid for:
2 years from
approval
UNIVERSITY OF MALTA
FACULTY OF MEDICINE & SURGERY
PHARMACY DEPARTMENT
Ref. No.
SOP/PD/213_02
STANDARD OPERATING PROCEDURE
COAGUCHEK® S
1
Repeatedly press Set button to scroll
between different configuration
parameters in Set Mode
(see SOP/PD/213_02/A1)
Press M button to change setting
that is currently flashing
Repeatedly press M button until
desired setting is displayed
Press Set button to
confirm selected setting
Press On/Off button to
switch device Off
End
Page 10 of 17
Valid for:
2 years from
approval
UNIVERSITY OF MALTA
FACULTY OF MEDICINE & SURGERY
PHARMACY DEPARTMENT
Ref. No.
SOP/PD/213_02
STANDARD OPERATING PROCEDURE
COAGUCHEK® S
5.7.2.
Operation
Start
Take out one test strip foil
pouch from refrigerator
Wait at least 5 minutes for foil pouch
to reach room temperature
Place device on level stable surface
or hold it in such a way as to be
roughly in a horizontal position
Press On/Off button to switch device On
Check that displayed code chip number
corresponds to the three digits which
follow the word “LOT” on foil pouch
Wait until a flashing test strip
icon is displayed
Open foil pouch and take out test strip
Insert test strip into test strip guide [D]
in the direction of the arrows
on the end of test strip
Slide test strip in as far as it will go
Check that “PT” is still visible after
test strip has been inserted
Wait for about 45 seconds until test
strip is warmed up to preset temperature
Wait until blood drop icon starts
flashing to indicate that device is ready
to perform test
1
Page 11 of 17
Valid for:
2 years from
approval
UNIVERSITY OF MALTA
FACULTY OF MEDICINE & SURGERY
PHARMACY DEPARTMENT
Ref. No.
SOP/PD/213_02
STANDARD OPERATING PROCEDURE
Valid for:
2 years from
approval
COAGUCHEK® S
1
A drop of blood must now be applied
to the test strip in 180 seconds
Apply first drop of blood directly to
sample application area of test strip
Wait until result is displayed
Result is automatically
saved in memory
No
Result displayed
in INR
Remove test strip from test strip guide
Yes
No
Up or Down arrow
displayed next to
result
Slide used lancet and test strip into
open foil pouch and discard
in sharps container
No
Yes
Value is outside target range
Need to access
memory
Press On/Off button to
switch device Off
Wait until flashing test strip
icon is displayed
End
Yes
Press Mem button
Repeatedly press Mem button to
scroll through the different
readings stored in memory
Page 12 of 17
UNIVERSITY OF MALTA
FACULTY OF MEDICINE & SURGERY
PHARMACY DEPARTMENT
Ref. No.
SOP/PD/213_02
STANDARD OPERATING PROCEDURE
COAGUCHEK® S
5.7.3.
Quality Control
Start
Take one test strip and one vial of
control solution out of refrigerator
Wait at least 5 minutes until both
items reach room temperature
Pull small tab to remove blue
sealing foil from vial
Hold vial in a vertical position
Tap bottom of vial hard against a steady
surface so that glass capsule inside
vial sinks to the bottom
Wrap vial in a cloth and squeeze bottom
half of vial firmly between index
finger and thumb to break
the inner glass capsule
Start timing 2 minutes when
glass capsule is broken
Raise arm to shoulder level and
strike vial hard against table top
to mix control solution
Repeat this procedure 10 times
Leave vial lying on a steady surface
for the rest of the 2 minutes
Press On/Off button to switch device On
Wait until a flashing test strip
icon is displayed
Insert test strip into device and
push it firmly inside
1
Page 13 of 17
Valid for:
2 years from
approval
UNIVERSITY OF MALTA
FACULTY OF MEDICINE & SURGERY
PHARMACY DEPARTMENT
Ref. No.
SOP/PD/213_02
STANDARD OPERATING PROCEDURE
Valid for:
2 years from
approval
COAGUCHEK® S
1
Wait for approx. 45 seconds until test
strip is warmed up to preset temperature
Wait until flashing blood drop
icon is displayed
A drop of control solution must now be
applied to test strip in 180 seconds
Shake contents of vial
vigorously in direction of cap
Turn cap gently and pull it
off while opening part of
vial is pointing downwards
Squeeze first drop of control solution
into cap and discard
Apply second drop to flashing yellow
application area on test strip
Check that no air bubbles are present
Wait for about 1 minute until
result is displayed together
with a [c] adjacent to it
Device will automatically
save result in memory
No
Result is within
specified control
range supplied with
control solution
Yes
Device is functioning correctly
End
Page 14 of 17
Contact supplier
UNIVERSITY OF MALTA
FACULTY OF MEDICINE & SURGERY
PHARMACY DEPARTMENT
Ref. No.
SOP/PD/213_02
STANDARD OPERATING PROCEDURE
Valid for:
2 years from
approval
COAGUCHEK® S
5.7.4.
Maintenance
Start
Check that device is switched off before
performing any maintenance procedures
No
Battery icon
flashing
Yes
Replace all 4 batteries (1.5V AA LR6)
or use device with mains adapter
Outside of device
needs cleaning
No
Yes
Clean with a moistened lint-free swab
Dry with a lint-free swab
Hand icon displayed
on switching
device On
Yes
Check that device is switched Off
Lift measurement chamber flap
until it is fully open
Clean test strip guide and
underside of flap with a slightly
moistened cotton bud
Dry test strip guide and underside of
flap with a lint-free swab
Leave measurement chamber
open for 10 minutes to dry
properly before closing flap
End
Page 15 of 17
No
UNIVERSITY OF MALTA
FACULTY OF MEDICINE & SURGERY
PHARMACY DEPARTMENT
Ref. No.
SOP/PD/213_02
STANDARD OPERATING PROCEDURE
COAGUCHEK® S
Valid for:
2 years from
approval
6. Precautions
Operate the device in an ambient temperature of +18oC to +32oC.
Keep the device, the code chip and the test strips away from any
magnetic objects and magnetic fields, such as cellular phones or
microwave ovens.
6.3. Do not store the device in damp and humid conditions.
6.4. Store the CoaguChek® PT Test Strips and the control solutions at a
temperature of 2-8oC.
6.5. Always operate the device with the correct set time and date.
6.6. Do not carry out measurements in direct sunlight.
6.7. Do not wait for more than 15 seconds after lancing the fingertip before
applying the blood to the test strip since longer times would falsify the
result as the coagulation process would already have begun.
6.8. Do not remove or insert a code chip while the device is performing a
test.
6.9. Do not use a different code chip from the one supplied with the test
strips that are being used.
6.10. Ensure that a quality control check is performed when:
6.1.
6.2.
6.10.1. Starting a new pack of test strips
6.10.2. Test strips have been stored and/or handled incorrectly
6.10.3. Measurements are being continually obtained outside the
therapeutic range.
7. Reference
Roche Diagnostics. CoaguChek® S User’s Manual. Mannheim: Roche
Diagnostics GmbH; 2001.
8. Appendices
SOP/PD/213_02/A1 – Configuration Parameters 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
Page 16 of 17
UNIVERSITY OF MALTA
FACULTY OF MEDICINE & SURGERY
PHARMACY DEPARTMENT
Ref. No.
SOP/PD/213_02
STANDARD OPERATING PROCEDURE
COAGUCHEK® S
Valid for:
2 years from
approval
SOP/PD/213_02/A1 – Configuration Parameters Table
Setting
Display Symbol
Time
[SET] [xx:xx]
Date
[SET] [xx-xx-xx]
Primary Unit
Secondary Unit
[SET] [INR],[SET]
[%Q],[SET] [Sec]
or [SET] [PTR]
[INR], [%Q], [Sec],
[PTR]or field left
blank
Steady bell symbol
when switched On
Beep Tone
Flashing bell
symbol when
switched Off
Time Format
[12] or [24]
Date Format
[xx-xx-xx]
Page 17 of 17
Function
To enter the time in the following
order: Hours, Minutes
To enter the date in the following
order: Month, Day, Year
To select the desired primary unit
To select the desired secondary
unit
To select between switching On
or Off the beep tone signal.
Device will beep in the following
situations:
- When it is switched On
- Each time a button is pressed
- When it detects test strip
- When a sample is required
- When it detects sample
- When result is displayed
- When an error occurs
To select between a 24-hour or a
12-hour time format with a.m. and
p.m.
To select between:
Month-Day-Year
Day-Month-Year
Year-Month-Day