UNIVERSITY OF MALTA
FACULTY OF MEDICINE & SURGERY
PHARMACY DEPARTMENT
Ref. No.
SOP/PD/228_01
STANDARD OPERATING PROCEDURE
URISYS® 1100
Page 1 of 16
Valid for:
2 years from
approval
UNIVERSITY OF MALTA
FACULTY OF MEDICINE & SURGERY
PHARMACY DEPARTMENT
Ref. No.
SOP/PD/228_01
STANDARD OPERATING PROCEDURE
URISYS® 1100
Valid for:
2 years from
approval
1. Scope
This Standard Operating Procedure (SOP) applies to the staff and students using the
Urisys® 1100 analyser in the Pharmacy Practice Resource Unit (PPRU) at the
Pharmacy Department, University of Malta.
2. Objective
To describe the procedure for set-up, configuration, operation, recording and recalling
of results, quality control, maintenance and troubleshooting of the Urisys® 1100
analyser.
3. Definitions
3.1.
Calibration test: Automatically requested upon first use of analyser and/or if
analyser is not used for more than 7 days.
3.2.
Control-Test M strip: Calibration strip used when using Combur10TestUX
test strips; each strip should be used only once.
3.3.
Error message: Shown in the display but are not printed; following 5 minutes
of inactivity, analyser switches to ‘Standby mode’ and error message is
displayed again when START button is pressed.
3.4.
Linefeed: Causes paper to advance to allow a new roll of paper to be inserted;
linefeed is stopped by pressing left function key ‘Stop’.
3.5.
Memory: Stores up to 100 results together with date and time of
measurement, sequence number and patient identity.
3.6.
Print results: To generate a printout of stored results; options include, ‘All’
which refers to all results in memory, ‘Last Series’ which refers to the most
recent series of readings and ‘Last One’ which refers to the most recent
reading. Printing can be repeated as often as desired and can be interrupted by
pressing left function key ‘Stop’ and subsequently resumed.
3.7.
Self check: Checks that program chip, tray transport mechanism, printer
connection and optical system are functioning correctly; also checks tray type
to ensure that it correctly matches strip type selected.
3.8.
Tray type: ‘Type C’ reads Combur10TestUX test strips; ‘Type N’ reads
Combur7Test and Combur5Test test strips.
Page 2 of 16
UNIVERSITY OF MALTA
FACULTY OF MEDICINE & SURGERY
PHARMACY DEPARTMENT
Ref. No.
SOP/PD/228_01
STANDARD OPERATING PROCEDURE
URISYS® 1100
3.9.
Valid for:
2 years from
approval
Units: Options include conventional (mg/dL), SI (mmol/L) or arbitrary (1+,
2+, 3+, 4+); single or combined units may be selected.
3.10. Urisys® 1100 analyser: A reflectance photometer designed to read and
evaluate the urine test strips (strip types: Combur10TestUX, Combur7Test and
Combur5Test by Roche). It reads the strips under standardised conditions,
saves the results to memory and outputs them via its own inbuilt printer and/or
serial interface. Can be connected to AT/PC keyboard or barcode reader to
enter password, patient ID and operator ID.
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.
Components and functions of Urisys® 1100 analyser
Page 3 of 16
UNIVERSITY OF MALTA
FACULTY OF MEDICINE & SURGERY
PHARMACY DEPARTMENT
Ref. No.
SOP/PD/228_01
STANDARD OPERATING PROCEDURE
URISYS® 1100
5.2.
Installation and Set-up
5.2.1.
5.2.2.
5.2.3.
5.2.4.
5.2.5.
5.2.6.
5.2.7.
5.3.
Valid for:
2 years from
approval
Connect analyser to AC power.
Select appropriate tray type and with retaining bar nearest to you
pushed down, slide it into the slot below function keys.
To load paper roll:
5.2.3.1. Press structured area below the cover to release printer paper
cover.
5.2.3.2. Lift cover backwards.
5.2.3.3. Place paper roll in the compartment.
5.2.3.4. Pull out first few centimetres of paper to just beyond the
edge of the compartment with outer surface of the paper roll
(thermosensitive side) facing downwards.
5.2.3.5. Close cover until it locks into position.
Switch analyser ‘On’; analyser automatically performs a self check:
‘SELF CHECK OK’ is printed together with date and time, if set.
Set strip settings (type, units and reflectance range limits) from
‘SETUP 1’ Menu.
Set date and time from ‘SETUP 2’ Menu.
Set language from ‘SETUP 3’ Menu.
Calibration
5.3.1.
5.3.2.
5.3.3.
5.3.4.
5.3.5.
5.3.6.
Press left function key ‘Yes’ when ‘REPEAT CALIBRATION’ is
displayed to perform calibration; message ‘START CALIBRATION’
is displayed.
Press middle function key ‘No’ if calibration is not required; ‘INSERT
STRIP’ is displayed.
Clean and dry test strip tray before calibration (section 5.6).
Press ‘START’ button; wait 1 minute for analyser to heat up.
Place calibration strip with test pads facing upwards on tray so that its
leading edge is held by the clip at the front end of insertion slot;
retaining bar must be open.
Perform calibration test (automatic in 60 seconds):
5.3.6.1. When calibration results are within permitted range
‘CALIBRATION OK’ is automatically displayed; result is
printed with date and time and a list of reflectance values for
measuring positions 1-11.
5.3.6.2. Remove and dispose of calibration strip.
5.3.6.3. When calibration results are outside permitted range, the
messages ‘REFERENCE PAD ERROR!’, ‘CALIBRATION
INVALID!’ or ‘CALIBRATION ERROR!’ appear (section
5.5).
Page 4 of 16
UNIVERSITY OF MALTA
FACULTY OF MEDICINE & SURGERY
PHARMACY DEPARTMENT
Ref. No.
SOP/PD/228_01
STANDARD OPERATING PROCEDURE
URISYS® 1100
Valid for:
2 years from
approval
5.3.6.4. Repeat calibration with a new calibration strip when a
calibration error occurs.
5.3.6.5. Press the ‘START’ button to return to ‘START
CALIBRATION’ (refer to 5.3.3-5.3.6).
5.3.6.6. Contact service technician if calibration remains invalid.
5.4.
Performing the Test
5.4.1.
5.4.2.
5.4.3.
5.4.4.
5.4.5.
5.4.6.
5.4.7.
Dip test strip in urine sample for 1 second; draw the long edge of the
strip along the rim of the urine specimen container to remove excess
urine.
Touch the long edge and back side of test strip on a clean, absorbent
surface, such as a kitchen towel.
Place test strip with test pads facing upwards correctly on the test strip
tray so that its leading edge is held by the clip at the insertion slot; the
retaining bar must be open and about 2mm of strip must be held under
the clip.
Press ‘START’ button (5-10 seconds after test strip is dipped); a beep
is heard and retaining bar will close. Push test strip manually if
required.
Perform measurement (automatic in 45 seconds).
Remove and discard test strip as biohazardous waste when
measurement is complete. Result will be printed and next sample
number is displayed.
Wipe any urine residues from the tray using a lint-free cloth.
Page 5 of 16
UNIVERSITY OF MALTA
FACULTY OF MEDICINE & SURGERY
PHARMACY DEPARTMENT
Ref. No.
SOP/PD/228_01
STANDARD OPERATING PROCEDURE
URISYS® 1100
5.5.
Valid for:
2 years from
approval
Troubleshooting
Error Message
E1 REFERENCE PAD
ERROR MIDDLE!
E15 REFERENCE PAD
ERROR BOTTOM!
E16 REFERENCE PAD
ERROR TOP!
E2 WRONG STRIP!
E3 STRIP MEASUREMENT ERROR!
E4 CALIBRATION ERROR!
E5 CALIBRATION INVALID!
Cause/Action
Cause: Middle portion of reference pad on
tray is soiled or damaged.
Action: Switch off analyser; carefully clean
and dry pad; check for damage (e.g.
scratching); insert tray again and wait for self
check to finish. Replace pad tray if error
message is repeated and re-calibrate with
calibration strips. Contact service technician.
Cause: Bottom portion of reference pad on
tray is soiled or damaged.
Action: Same as E1
Cause: Top portion of reference pad on tray
is soiled or damaged.
Action: Same as E1
Cause: Test strip used is different from one
for which analyser has been programmed.
Action: Press START; repeat measurement
with type of strip for which analyser has been
programmed.
Cause: No test strip present on tray, strip
incorrectly positioned on tray, urine on strip
dried or strip has not been dipped in urine.
Action: Press START; repeat measurement
with new strip; ensure that all test pads are
dipped in urine sample; insert strip correctly
and ensure that retaining bar is closed
properly after START is pressed.
Cause: Calibration values differ from those
obtained in last valid calibration.
Action: Press START; repeat calibration
with new calibration strip; ensure that strip is
correctly positioned under clip at end of test
strip tray.
Cause: Calibration values out of tolerance.
Action: Check reference pad for soiling/
damage; clean if necessary and repeat
calibration with new calibration strip.
Contact service technician if error message
appears again since analyser is defective.
Page 6 of 16
UNIVERSITY OF MALTA
FACULTY OF MEDICINE & SURGERY
PHARMACY DEPARTMENT
Ref. No.
SOP/PD/228_01
STANDARD OPERATING PROCEDURE
URISYS® 1100
E6 CHIP ERROR!
E7 MISSING TRAY!
E8 TRAY POSITION ERROR!
E8 WRONG TRAY!
E10 LIGHT BARRIER ERROR!
Valid for:
2 years from
approval
Cause: Program chip on right of analyser
underneath printer cover is missing, not
making contact, defective or contains an old
software version.
Action: Switch analyser Off; insert program
chip and switch analyser On again. Contact
service technician if error message appears
again since analyser is defective.
Cause: No tray inserted or tray not inserted
far enough to be engaged by motor.
Action: Insert tray correctly; press START.
Cause: Positioning hole in tray is soiled or
still wet after cleaning, retaining bar is open
while tray is advancing or retaining bar
mechanism is fouled with urinary deposit and
blocked.
Action: Clean, blow through or dry
positioning hole using lint-free cloth to
ensure that it is completely patent; remove
urinary deposits including those on underside
of tray; insert tray again and press START;
ensure retaining bar is down and locked in
place while reading is taking place. Contact
service technician if error message appears
again to order another tray.
Cause: Test strip tray used is not the one for
programmed test strip type, grey reference
pad is missing from tray or there is an
analyser error.
Action: Press START; strip type menu is
displayed (strip type must match tray type);
use correct tray or order a new one. Contact
service technician if error message appears
again since analyser is defective.
Cause: Light barrier used to control position
of test strip tray is defective or tray transport
is blocked.
Action: Pull out tray and return it to start
position; press START. Contact service
technician if error message appears again
since analyser is defective.
Page 7 of 16
UNIVERSITY OF MALTA
FACULTY OF MEDICINE & SURGERY
PHARMACY DEPARTMENT
Ref. No.
SOP/PD/228_01
STANDARD OPERATING PROCEDURE
URISYS® 1100
E11 MOTOR STEP ERROR!
E12 OPTICS ERROR!
CLOSE PRINTER COVER
NO PAPER IN PRINTER
E14 INTERFACE ERROR!
E17 INVALID PASSWORD!
E18 INVALID OP.ID!
E19 LIST DOWNLOAD FAILED
Valid for:
2 years from
approval
Cause: Stepping of motor is out of tolerance
or advance of tray is blocked due to soiling
on or between cogs, worn out or broken cogs
or defective motor.
Action: Carefully clean tray; remove any
urinary deposits including those on underside
of tray and cogs; if tray is damaged insert
spare tray; press START. Contact service
technician if error message appears again
since analyser is defective.
Cause: Reference pad is missing from tray,
or an LED or phototransistor is defective.
Action: Attach reference pad or use spare
tray; press START. Contact service
technician if error message appears again
since analyser is defective.
Cause: Printer cover is open.
Action: Close printer cover.
Cause: No paper has been inserted or roll
finished.
Action: Insert new paper roll; close printer
cover. After elimination of printer errors
results can be printed from analyser’s
memory using ‘Print’ function.
Cause: Fault in data transfer to PC or host in
bidirectional or ASTM mode.
Action: Check data cable; verify that PC or
host is ready to receive data; use ‘Send
function to transfer data or press ‘Home’ to
resume ‘Ready-to-Measure’ status.
Cause: Password entered does not match.
Action: Enter correct password.
Cause: Operator ID entered is not valid.
Action: Enter valid Operator ID.
Cause: New Operator ID list download
failed.
Action: No action; after 2 seconds next state
starts with old list if present.
Page 8 of 16
UNIVERSITY OF MALTA
FACULTY OF MEDICINE & SURGERY
PHARMACY DEPARTMENT
Ref. No.
SOP/PD/228_01
STANDARD OPERATING PROCEDURE
URISYS® 1100
E20 NO VALID LIST!
CHECK MEASUREMENT
VALUES OBTAINED ARE
IMPLAUSIBLE WHEN COMPARED
TO THOSE FROM
VISUAL EVALUATION
NO PRINTOUT
THE ANALYZER WILL NOT READ
EVEN THOUGH THE SEQUENCE
NUMBER IS DISPLAYED
Valid for:
2 years from
approval
Cause: There is no valid list in analyser.
Action: Try to download an Operator ID list
from host or continue without authenticated
operator.
Analyser prints out software and chip
version number and 3-digit numbers without
naming the parameters.
Cause: Service function is activated.
Action: Press ‘Back’ function key to return
to main menu.
Cause: Test strip incorrectly positioned or
uncharacteristic test pad colours, wrong test
strip may have been used or electromagnetic
interference from other devices.
Action: Repeat measurement with new test
strip; follow directions carefully and ensure
test strip is correctly inserted; repeat
calibration if necessary; remove external
sources of interference if present.
Cause: ‘Printer: Off’ has been selected,
printer/software is defective or printer is out
of paper.
Action: Insert paper if needed; select
‘Printer: On’ to re-activate printer; request a
patient report via ‘Print’ function; activate
‘Linefeed’ function if this fails. Contact
service technician if error message appears
again.
Action: If an AT/PC keyboard is connected,
press the Escape key or switch device Off
and On again.
Page 9 of 16
UNIVERSITY OF MALTA
FACULTY OF MEDICINE & SURGERY
PHARMACY DEPARTMENT
Ref. No.
SOP/PD/228_01
STANDARD OPERATING PROCEDURE
URISYS® 1100
5.6.
Valid for:
2 years from
approval
Cleaning and Maintenance
5.6.1.
General cleaning
Clean exterior parts and surfaces of analyser with a moist cloth using a
commercial cleaning agent or disinfectant, preferably 70% alcohol.
5.6.2.
Test strip tray cleaning
5.6.2.1. Switch analyser ‘Off’.
5.6.2.2. Pull test strip tray out of analyser.
5.6.2.3. Rinse with running water.
5.6.2.4. Remove any crystalline deposits with a soft brush, especially
those contaminating the retaining bar mechanism or the cogs on
the underside of test strip tray.
5.6.2.5. Wipe down test strip tray with 70% alcohol or other suitable
disinfectant.
5.6.2.6. Dry with a soft lint-free cloth.
5.6.2.7. Install test strip tray.
5.6.2.8. Switch analyser ‘On’.
Page 10 of 16
UNIVERSITY OF MALTA
FACULTY OF MEDICINE & SURGERY
PHARMACY DEPARTMENT
Ref. No.
SOP/PD/228_01
STANDARD OPERATING PROCEDURE
URISYS® 1100
5.7.
Valid for:
2 years from
approval
Flowcharts
5.7.1.
Installation and Set-up
Start
Connect analyser to AC power
Select appropriate tray type and with retaining bar nearest to you
pushed down, slide it into slot below function keys





To load paper roll:
Press structured area below cover to release printer paper cover
Lift cover backwards
Place paper roll in the compartment
Pull out first few centimetres of paper to just beyond the edge of the
compartment with outer surface of the paper roll facing downwards
Close cover until it locks into position
Switch analyser ‘On’; analyser automatically performs a self check:
‘SELF CHECK OK’ is printed together with date and time (if set)
Set strip settings (type, units and range limits) from ‘SETUP 1’ Menu
Set date and time from ‘SETUP 2’ Menu
Set language from ‘SETUP 3’ Menu
End
Page 11 of 16
UNIVERSITY OF MALTA
FACULTY OF MEDICINE & SURGERY
PHARMACY DEPARTMENT
Ref. No.
SOP/PD/228_01
STANDARD OPERATING PROCEDURE
Valid for:
2 years from
approval
URISYS® 1100
5.7.2.
Calibration
Start
‘REPEAT CALIBRATION’ is displayed
Press middle function key ‘No’;
‘INSERT STRIP’ is displayed
Calibration
required?
No
Yes
Press left function key ‘Yes’ to perform calibration; ‘START CALIBRATION’ is displayed
Clean and dry test strip tray before calibration
Press ‘START’ button; wait 1 minute for analyser to heat up
Place calibration strip with test pads facing upwards on tray so that its leading edge is held by
the clip at the front end of insertion slot; retaining bar must be open
Perform calibration test (automatic in 60 seconds)
CALIBRATION
OK displayed?
No
Yes
Result is printed with date/time + list of
reflectance values for measuring positions 1-11
Remove and dispose of calibration strip
1
Page 12 of 16
UNIVERSITY OF MALTA
FACULTY OF MEDICINE & SURGERY
PHARMACY DEPARTMENT
Ref. No.
SOP/PD/228_01
STANDARD OPERATING PROCEDURE
URISYS® 1100
Valid for:
2 years from
approval
1
Messages ‘REFERENCE PAD ERROR!’, ‘CALIBRATION INVALID!’
or ‘CALIBRATION ERROR!’ appear
Repeat calibration with a new calibration strip
Press the ‘START’ button to return to ‘START CALIBRATION’
Contact service technician if calibration remains invalid
End
Page 13 of 16
UNIVERSITY OF MALTA
FACULTY OF MEDICINE & SURGERY
PHARMACY DEPARTMENT
Ref. No.
SOP/PD/228_01
STANDARD OPERATING PROCEDURE
URISYS® 1100
5.7.3
Valid for:
2 years from
approval
Performing the Test
Start
Dip test strip in urine sample for 1 second; draw the long edge of the strip
5.8.along rim of urine specimen container to remove excess urine
Touch long edge and back side of test strip on a clean, absorbent surface
Place test strip with test pads facing upwards correctly on test strip tray so
that its leading edge is held by clip at the insertion slot; retaining bar must be
open and about 2mm of strip must be held under clip
Press ‘START’ button (5-10 seconds after test strip is dipped); a beep is
heard and retaining bar will close; push test strip manually if required
Perform measurement (automatic in 45 seconds)
Remove and dispose of test strip;
result will be printed and next sample number is displayed
Wipe any urine residues from the tray with a lint-free cloth
End
Page 14 of 16
UNIVERSITY OF MALTA
FACULTY OF MEDICINE & SURGERY
PHARMACY DEPARTMENT
Ref. No.
SOP/PD/228_01
STANDARD OPERATING PROCEDURE
URISYS® 1100
Valid for:
2 years from
approval
6.
Precautions
6.1.
Always wear disposable gloves when performing a test.
6.2.
Discard urine sample, test strip and gloves as biohazardous waste.
6.3.
Protect analyser from extremes of temperature and high atmospheric humidity.
6.4.
Do not set up analyser close to devices that create high-frequency fields as
they may interfere and produce inaccurate results.
6.5.
Keep analyser out of bright light.
6.6.
Do not touch grey reference pad as contamination may impair quality of the
results obtained.
6.7.
Ensure that no damage is done to grey reference pad during cleaning and
ensure that it is completely clean and dry before proceeding with
measurement.
6.8.
Perform regular calibration to ensure reliability of results obtained.
6.9.
Allow test strips to react for approximately 45 seconds before inserting them
into analyser and pressing start; false-low or false-negative results may be
obtained for some parameters if incubation time outside analyser is too long.
6.10. Ensure that no urine residues come into contact with retaining bar mechanism
when inserting and removing test strips.
6.11. Wipe off urine residues from tray with a lint-free cloth after each reading to
prevent carry-over and accumulation of urine deposits.
6.12. Switch off analyser at the end of each working day.
7. References
Roche Diagnostics GmbH. Urisys® 1100 Operator’s manual. Germany: Roche
Diagnostics; 2008.
Page 15 of 16
UNIVERSITY OF MALTA
FACULTY OF MEDICINE & SURGERY
PHARMACY DEPARTMENT
Ref. No.
SOP/PD/228_01
STANDARD OPERATING PROCEDURE
URISYS® 1100
Valid for:
2 years from
approval
8. Appendices
N/A
9. Revision History
Version Number
01
Amendments/ Reasons for change
Initial Release
Page 16 of 16