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Related Manuals for Roche cobas Urisys 1100

Related Manuals for Roche cobas Urisys 1100

Detail Specifications: 1977/1977666-cobas_urisys_1100.pdf file (17 Jan 2023)

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Roche cobas Urisys 1100 Measuring Instruments PDF Operator’s Manual (Updated: Tuesday 17th of January 2023 04:41:46 AM)

Rating: 4.3 (rated by 48 users)

Compatible devices: Cobas C 311, CoaguChek XS System, CoaguChek INRange, Cedex Bio, COBAS INTEGRA 400 plus, Cobas C111, CoaguChek XS Plus, Cedex HiRes.

Recommended Documentation:

Text Version of Operator’s Manual

(Ocr-Read Summary of Contents, UPD: 17 January 2023)

Recommended Instructions:

F8354001, CT-13R32, HGTL09111C, CSBL 100, SX-A6-J, XSD27ZS

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Operating Impressions, Questions and Answers:

Urisys 1100

Urine Analyzer

Policies and Proceduresfor use with Urisys 1100 Urine
Analyzer

This is a CLIA-Waived System

Roche Diagnostics is not responsible for any changes made to
this diskette by the customer.

IntroductionRoche Diagnostics is pleased to assist you in
developing policies and procedures and implementing regulations of
the Clinical Laboratory Improvement Amendment of 1988 (CLIA 88) in
your facility. This guide contains sample policies and procedures
for use with the Urisys 1100 Urine Analyzer. These sample policies
and procedures are intended only as a guide, and it is important
that you make whatever adjustments may be required as a result of a
change in policy or a change in law or regulations or their
interpretation.

A total quality management program should include written
policies and testing procedures that are customized for your
particular facility. Any policies and procedures that involve using
Chemstrip urine test strips should be written prior to the start of
any urine testing. This guide provides sample policies and
procedures that meet the Section 493.1211 requirements. Blank
spaces let you customize the policies and procedures with
information specific to your facility. You are encouraged to
highlight impor-tant areas and procedures currently in use.We
suggest you store a Urisys 1100 Urine Analyzer Operators Manual,
Chemstrip urine test strip package insert and control package
insert in the Product Information section for quick reference. You
may also want to include the following clinical guidelines and
regulations in the Regulatory Requirements section.

1 JCAHO Guidelines 2 CAP Guidelines 3 CLIA 88 Guidelines 4 State
Guidelines 5 Bloodborne Pathogen Standard If you have any
questions, please call Roche Diagnostics Technical Service Center
at 1-800-4284674, available 7 days per week, 24 hours a day, and
365 days per year.

Approval ProcessThe following policies and procedures must be
approved, signed and dated by the laboratory director. If a new
director is placed in charge, the procedures must be re-approved,
signed, and dated by the new director. In addition, any changes to
the manual must be approved, signed, and dated by the laboratory
director.

You must maintain a copy of each procedure with the date of the
initial use and the date the test was discontinued. Keep these
records for at least two years after the procedure has been
discontinued.Approval date ____________________ Approved by:
_____________________________________________________

Reviewed/Revised Date ___________________ __ ___________________
__ ___________________ __ ___________________ __
___________________ __ ___________________ __ ___________________
__ ___________________ __ By Whom
___________________________________ __
___________________________________ __
___________________________________ __
___________________________________ __
___________________________________ __
___________________________________ __
___________________________________ __
___________________________________ __ Title
_________________________________ __
_________________________________ __
_________________________________ __
_________________________________ __
_________________________________ __
_________________________________ __
_________________________________ __
_________________________________ __

PurposeTo establish safe, accurate urine test results to be used
for screening and monitoring patient status.

General Policies and Procedures1 The policies and procedures
pertaining to urinalysis with the Urisys 1100 Urine Analyzer are
reviewed at least once a year. 2 Any changes to the text as they
apply to methodology or testing policy are signed by the
appropriate authority, dated, and inserted in the policies and
procedures manual. 3 Obsolete or superseded procedures are replaced
in the manual, but are retained for compliance purposes. 4 The most
recent package inserts and the Urisys 1100 Urine Analyzer Operators
Manualprovided by Roche Diagnostics should be referenced for the
most recent procedural information.

Table of ContentsI. Policies and Procedures

1 1

A.B. C. D.E.

Principle of OperationSpecimen Collection 3

Test Strip Storage and Stability

4

Calibration of the Urisys 1100 Urine Analyzer Testing with the
Urisys 1100 Urine Analyzer of Urinalysis Results 12 1315

5 7

F. Documentation

11

G. H. I.

Expected Values

Quality Control Procedure

Documentation of Quality Control Results

J. II.III. IV.

Limitations of the Procedure 1618 20 21

Preventive Maintenance

Infection Control Guidelines

Operator Certification/Recertification

V.VI.

Appendix

25 28 44 45

Log Sheets

VII. Regulatory Requirement VIII. Product Information

Urisys 1100 and CHEMSTRIP are trademarks of a Member of the
Roche Group. All other trademarks are the property of their
respective holders. 2003 Roche Diagnostics. All rights reserved.
REF 03755541001 (03)

1 Glucose Test: Glucose detection is based on the enzymatic
glucose oxidase/peroxidase (GOD/POD)method. The reaction utilizes
the enzyme glucose oxidase to catalyze the formation of gluconic
acid and hydrogen peroxide from the oxidation of glucose. In turn,
a second enzyme, peroxidase, catalyzes the reaction of hydrogen
peroxide with the chromogen tetramethylbenzidine to form a green
dye complex. A positive reaction is indicated by a color change
from yellow to green.9, 10

2 Ketone Test: Based on the principle of Legals Test, sodium
nitroprusside and glycine react with acetoacetate and acetone in an
alkaline medium to form a violet dye complex. A positive result is
indicated by a color change from beige to violet. 11, 12 3
Urobilinogen Test: Urobilinogen is coupled with
4-methoxybenzene-diazoniumtetrafluoroborate in an acid medium to
form a red azo dye.13 4 Bilirubin Test: The detection of bilirubin
is based on the coupling reaction of a diazonium salt with
bilirubin in an acid medium. The reaction yields a pink to
red-violet color proportional to the total bilirubin concentration.
14 (Some users may describe this as a cream to peach color.) 5
Blood Test: Hemoglobin and myoglobin, if present, catalyze the
oxidation of the indicator by the organic peroxidecontained in the
test pad. Intact erythrocytes hemolyze on the test pad and liberate
hemoglobin, which produces a green dot. Since the test pad absorbs
several microliters of urine, more erythrocytes become visible than
would cor-respond to 1L.15-19 Separate sets of color blocks are
representative of erythrocytes and hemoglobin. Scattered or
compacted green dots on the yellow test pad are indicative of
intact erythrocytes, or myoglobin.

6 Compensation Pad: The compensation area is not impregnated
with reagent. This pad allows the instrument to compensate for the
intrinsic color of urine, which may affect test results.

2

B.

Specimen Collection

Policy1 Use a freshly voided urine specimen, first-morning urine
specimen, or post-prandial urine specimen. 2 When testing urine
specimens, every precaution must be taken to avoid contamination of
the specimen and the operator. 3 Because of the potentially
hazardous nature of handling urine and the possibility of its
contamination with blood, it is recommended that disposable latex
gloves and laboratory coats be used when collecting specimens.
Consult your facilitys infection control policy. 4 Instructions for
collection of a clean-catch midstream urine specimen may be found
in Section V. Appendix.

Procedure1. Follow physicians order(s). 2. Assemble appropriate
supplies. 1 Cleansing towelette 2 Water-saturated sponge 3 Clean
urine container with lid 3. Instruct patient to wash genital area
(do not use towelettes with strong cleansing agents), rinse with
water, and thenobtain a clean-catch midstream urine sample in the
clean container. Refer to Section V. Appendix for instructions.

4. Test urine as soon as possible after collection to avoid
deterioration of specimen. If specimen cannot be tested within two
hours of collection, refrigerate immediately (at 2-8C) in a closed
container. Bring specimen to room temperature before testing. Mix
thoroughly before testing. 5. If urine is not tested immediately,
mix specimen thoroughly by capping container and swirling several
timesbefore testing to avoid incorrect results. Do not centrifuge
or add preservatives to the urine specimen.

3

C.

Test Strip Storage and Stability

Policy1 Store Chemstrip urine test strips at 2 C (36 F) 30 C (86
F). Do not freeze. 2 Opened Chemstrip urine test strips are stable
until the expiration date on the vial label when stored inthe
original capped vial. The vial must be closed immediately after
use, using the original cap.

4

D.

Calibration of the Urisys 1100 Urine Analyzer(with Chemstrip
10MD* Test Strips)

Policy1 Calibration is required if using the Chemstrip 10MD*
Test Strips. (When using Chemstrip 5 OB or Chemstrip 7 Test Strips,
the calibration procedure is not required. These test strips are
calibrated using the gray reference pad on the test strip tray.) 2
The Urisys 1100 Urine Analyzer must be calibrated every seven days
or when indicated by the analyzer. 3 The Chemstrip Urine Analyzer
Calibration Strips (Catalog Number 418007) should remain in the
vial until just before use. Do not touch the elevated gray areas on
the strips. 4 The calibration strips should be used only once. 5 If
you do not obtain a successful calibration, the analyzer will not
process samples. 6 Calibration should be documented on the
Preventive Maintenance Log.

Procedure1. Plug the power cord provided with the analyzer into
the power outlet at the rear of the analyzer and theninto a wall
outlet. Turn the analyzer on. The analyzer will then automatically
perform a self check. If the self check is completed successfully,
the message self check OK prints along with the time and date.

2. Make sure the test strip tray is clean and dry. Note: After a
successful self check, the operator may have to enter an operator
ID and password (if these options have been selected). 3. If the
message REPEAT CALIBRATION is in the display, press START. If the
analyzer is in Ready-to-Measuremode, press the left function key to
select Calibr. The message, START CALIBRATION appears on the
display.

4. Remove a calibration strip from its container, being careful
not to touch the pads. Do not allow the calibration strip to come
into contact with urine. 5. With the retaining bar open, place the
calibration strip, pads facing upward, onto the test strip tray and
insert the front edge of the strip under the plastic clip. 6. Press
the START button. You will hear a beep and then the tray advances
slightly, the retaining bar closes, and the calibration strip is
read. When calibration is complete, the tray moves to the start
position and the retaining bar opens. 7. Remove the calibration
strip and discard. Remember that each calibration strip is used
only once. 8. If the calibration is valid, results are stored in
memory, and a report with the reflectance values, time, and date
auto-matically prints. Reflectance values for positions 1 through
11 for the orange LED are printed in the middle column and for the
green LED in the right column.*Hospitals may use Chemstrip 10UA
Urine Test Strips.5

9. If the results for the reference pad or the calibration strip
are outside the programmed tolerances, one of the follow-ing
messages appears on the display: 1 REFERENCE PAD ERROR 2
CALIBRATION INVALID or 3 CALIBRATION ERROR If a calibration error
occurs, repeat the calibration procedure using a new calibration
strip. 1. Press the START button and the display will return to the
START CALIBRATION menu. 2. Place the new calibration strip on the
test strip tray and press the START button again. 3. If the
calibration is valid, the message CALIBRATION OK prints. 4.If the
calibration fails a second time and a calibration error appears on
the display, refer to the Operators Manual or call Roche
Diagnostics Technical Service at 1-800-428-4674, 7 days a week, 24
hours a day, and 365 days per year.

6

E.

Testing with the Urisys 1100 Urine Analyzer

Policy1 Only a certified operator may perform a urine test with
the Urisys 1100 Urine Analyzer. 2 Because of the potentially
hazardous nature of handling urine and the possibility of its
contamination with blood, it is recommended that disposable latex
gloves and laboratory coats be used when collecting specimens and
perform-ing test procedures. Consult your facilitys infection
control policy. 3 Urine should be handled at Biosafety Level 2 as
recommended for any potentially infectious material in the Centers
for Disease Control/National Institutes of Health manual, Biosafety
in Microbiological and Biomedical Laboratories , 1988.24 Universal
precautions may apply if the urine is contaminated with blood or if
required by the infection control policy of the facility. 4
Outdated Chemstrip urine test strips are discarded.

Procedure1. The following equipment is assembled prior to
testing: Urisys 1100 Urine Analyzer Chemstrip urine test strips
Patient specimen Disposable latex gloves (if required by facility)
Laboratory coat (if required by facility) Absorbent paper 2. Check
the expiration date on the Chemstrip urine test strip vial prior to
testing. 3. Plug the power cord provided with the analyzer into the
power outlet at the rear of the analyzer and theninto a wall
outlet. Turn the analyzer on. The analyzer will then automatically
perform a self check. If the self check is completed successfully,
the message self check OK prints along with the time and date.

Note: After successful self check, the operator may have to
enter their operator ID and password if these options have been
activated. 4. The Urisys 1100 Urine Analyzer is ready for
measurement as long as valid calibration values are stored inthe
ana-lyzer. Refer to Section I.D. Calibration of the Urisys 1100
Urine Analyzer of this manual.

5.

Verify the test strip tray is clean of any residue. If there is
residue on the tray, refer to Section II. Preventive Mainte-nance
of this manual for the cleaning procedure. Urine residue on the
test strip tray may result in inaccurate results.

6. If the sample has been refrigerated, allow it to come to room
temperature. Mix the specimen by capping the con-tainer and
swirling several times if not freshly voided.7

7. Remove the cap from the test strip vial and remove one
Chemstrip urine test strip. 8. Dip the test strip for one second in
the urine sample. Draw the edge of the test strip along the rim of
the specimen container. Gently touch (one second) the long edge of
the test strip to a piece of absorbent paper to remove any excess
urine. 9. If the analyzer is in Standby mode, press START to return
to Ready-to-Measure mode. The test strip trayand the retaining bar
must be in the open position. Place the test strip, with the pads
facing upward, onto the test strip tray and insert the front edge
of the strip under the plastic clip. It is important that the strip
is correctly positioned and the START button is pressed within 5-10
seconds of dipping the strip.

10.

Press the START button. You will hear a beep and then the tray
advances slightly, and the retaining bar closes.

First the gray reference pad located on the test strip tray is
read.

11.

If the test strip is not lined up straight on the test strip
tray, gently move it until it is properly lined up under the

retaining bar. Be careful not to move the tray.

12.

Approximately 60 seconds after the START key is pressed, all
test strip pads will be read. The results will print

and the next sample number appears on the display.

13.

The test strip tray will return to the start position and the
retaining bar will open. Remove the used test strip

and wipe the test strip tray as needed with a lint-free cloth to
remove any urine residue. Refer to Section II. Preventive
Maintenance of this manual for the cleaning procedure.

14.

Properly dispose of the urine, urine container and test
strip.

Guidelines1 Mechanical problems are evident when the analyzer
displays an error message. A chemistry problem may become evident
with an unexpected result. Abnormal results are flagged with an
asterisk. If you obtain an unexpected result on any chemistry,
refer to the Limitations and Performance Characteristics sections
of the Chemstrip urine test strip package insert. 2 If you are
comparing the analyzer values against the visual strip values and
the deviation is more than one concen-tration block, one of the
following may have occurred: 1 Test strip is not positioned
correctly in the test strip tray 2 Power supply failure or high
frequency interference by other devices 3 Visual strip is
deteriorated 4 Improper testing technique If one of the above
situations has occurred, repeat the measurement with a new test
strip, being very careful to properly position the test strip.
Remove any external source of interferences.8

The following is a list of error messages and suggestions on how
to eliminate the problem:Error Code E1 Error Description Reference
pad error Cause Gray reference pad on the test strip tray soiled or
damaged. Action Switch off the instrument. If not visibly damaged,
clean and dry the pad. Insert the tray and wait for the self-check
to finish. If the error message reoccurs, call Roche Diagnostics
Technical Service Center. Press the START button. Repeat the
measurement using the test strip that the instrument has been
programmed for.

E2

Wrong strip

E3

Strip measurement

The test strip used is different from the one for which the
analyzer has been programmed for (either Chem 10, Chem 5, or Chem
7). See Operators Manual. a) No test strip present on the tray. b)
Test strip is incorrectly positioned on the tray. c) Urine on the
test strip has dried. d) Test strip has not been dipped in urine.
Calibration values differ from those obtained in the last valid
calibration. Calibration values out of tolerance.

Press the START button. Repeat the measurement with a new test
strip. Make sure the strip is inserted correctly and that the
retaining bar properly closes after the START button is
pressed.

E4

Calibration Error

E5

Calibration Invalid

E6

Chip Error

The chip module underneath the printer cover is missing, not
making contact, or is defective. Test strip tray is missing or not
inserted far enough to engage the motor. The positioning hole in
the tray is dirty or still wet after cleaning; the retaining bar is
open while the tray is advancing; or the retaining bar mechanism is
contaminated with urine and blocked.

E7

Missing Tray Tray Position Error

Press the START button. Repeat the calibration using a new
calibration strip. Make sure the calibration strip is properly
positioned under the clip on the test strip tray. Check the
reference pad for soil or damage. Clean the reference pad or use
the spare tray. Repeat the calibration with a new calibration test
strip. If the error reappears, call Roche Diagnostics Technical
Service Center. Switch off the analyzer, insert the chip module and
switch the instrument on again. If the error message appears again,
call Roche Diagnostics Technical Service Center. Insert the test
strip tray correctly. (See Section 4 of Operators Manual.) Press
the START button. Clean, blow through, or dry the positioning hole
on the test strip tray using a lint-free cloth. Remove any urinary
deposits on both the top and bottom of the test strip tray. Insert
the tray again and press the START button. If the message error
persists, call Roche Diagnostics Technical Service

E8

E9

Wrong tray

E10

Light Barrier Error

E11

Motor Step Error

The test strip tray is not the one programmed for the analyzer
or the gray reference pad is missing from the tray. Gray reference
pad is scratched or dirty. The light barrier used to control the
position of the test strip is defective or the tray transport is
blocked. The stepping motor drive is out of tolerance or the
advance of the test strip tray is blocked.

E12

Optics Error

E13

Printer Error

The reference pad is missing from the test strip tray or an LED
or phototransistor is defective. Printer connection fault or paper
jam. This message will not appear if there is no paper.

Center. Press the START button. The strip type menu is
displayed. The strip type must match the tray type. (See Operators
Manual, Section 4.2.) Use the correct tray and make sure the gray
reference pad is clean. Press the START button. Pull out the tray
and return it to the start position. Press the START button. If the
error message persists, call Roche Diagnostics Technical Service
Center. Carefully clean the tray. Clean and dry the positioning
hole using a lint-free cloth. Remove any urinary deposits on both
the top and bottom of the test strip tray. Insert the tray again
and press the START button. If the message error persists, call
Roche Diagnostics Technical Service Center. Attach the reference
pad. Press the START button. If the error message appears again,
call Roche Diagnostics Technical Service Center. Switch off the
analyzer. If there is a paper jam, clear it. Switch the analyzer on
again. If the error message appears again, call Roche Diagnostics
Technical Service Center.

9

Error Code E14

Error Description Interface Error

Cause Unable to transfer data to PC or host in bi-directional
mode.

Action Check the data cable. Verify that the PC or host is ready
to receive data. Use the Send function to transfer data or press
Home to resume Ready-to-Measure status. see E1

E15 REFERENCE PAD ERROR BOTTO M! E16 REFERENCE PAD ERROR TOP!
E17 INVALID PASSWO RD! E18 INVALID

The bottom portion of the reference pad on the tray is soiled or
damaged.

The top portion of the reference pad on the tray is soiled or
damaged. The entered password doesnt match. The entered Operator ID
is not valid.

see E1

Enter an correct password.

Enter a valid Operator ID.

OP.ID! E19 LIST DOWNLO AD FAILED E20 NO VALID LIST! Check
Measuremen t

The new Operator ID list download failed. There is not a valid
list at all in device. Analyzer prints out software and chip
version number and 3-digit numbers without naming the parameters
Values obtained do not compare with those from visual
examination.

No action. After 2 seconds next state starts with old list if
there was. Try to download an Operator ID list from the host or
continue without authenticated operator. Press the Back function
key to return to the main menu.

Service function is activated.

a) Test strip incorrectly positioned on the test strip tray. b)
Uncharacteristic test pad colors. c) The wrong test strip, such as
the calibration strip, was used. d) Electromagnetic interference
from other devices. e) Improper storage or technique. Printer: Off
is selected or the printer/ software is defective.

Repeat the measurement with a new test strip. Follow the
procedure carefully and make sure the test strip is inserted
properly. Repeat calibration, if necessary. Move the analyzer to
another location if external interference is suspected.

No printout

Choose Printer: On to reactivate the printer. Request a patient
report through the Print function. If this fails, activate the
Linefeed function. If there is still no response, call ROCHE
DIAGNOSTICS Technical Service Center. Switch the analyzer off and
back on again.

The analyzer will not read, even though the sequence number is
displayed.

10

F.

Documentation of Urinalysis Results

Policy1 The date, time, initials of the operator, patient
name/patient ID number, and parameter values are recorded on the
patient chart or the appropriate log for your facility. 2 Test
requisitions, test authorizations, and test results are retained
for a minimum of two years. 3 Test requisition or authorization
includes: Patients name Name and address (or other identifier) of
the person requesting the test Test to be performedDate the sample
was obtained Date the test was performed

An audit trail exists, linking the patient test with the
Chemstrip test strip lot number and control lot number used.

Procedure1. Record the date, time, initials of the tester,
patient name/patient ID number, and test values on the Urinalysis
Report Form of this guide or the appropriate log for your facility.
2. Indicate the type of specimen (first morning, random,
clean-catch midstream, etc.) on the appropriate log.

(See Section VI. Log Sheets for sample log sheets.)

11

G.

Expected Values

GuidelinesPlease refer to the most recent Chemstrip urine test
strip package insert for any changes to the expected values
infor-mation. 1 Specific Gravity: Random urine specimens vary from
1.001 to 1.035. Twenty-four hour urine specimensfrom nor-mal adults
with normal diets and fluid intake will have a specific gravity of
1.016 to 1.022.22

2 pH: Urine pH values generally range from 5 to 9. The most
frequent pH values for firstmorning specimens in healthy subjects
are between 5 and 6. 3 Leukocytes: Normal urine should produce no
color reaction. Trace indicates a possible borderline situation,
and the test should be repeated on a fresh urine sample from the
patient. Positive and repeated trace findings indicate the need for
further testing of the patient and/or urine sample in accordance
with the medically accepted proce-dures for pyuria. 4 Nitrite: A
nitrite concentration as low as 0.05 mg/dL will produce a slightly
pink coloration of the test pad. This indi-cates a positive result.
5 Protein: A color change from yellow to light green/green will
occur if protein is present in urine. The concentrations given on
the vial label correspond with the albumin concentration in urine.
Pathological proteinuria usually will pro-duce persistent values
above 30 mg/dL. Clinical significance of the trace result should be
determined by additional testing. 6 Glucose: Due to the tests
sensitivity, glucose should not be detectable in normal urine.
Therefore, any positive reaction should be followed by further
diagnostic evaluation of the patient, such as a quantitative blood
glucose or a glucose tolerance test. 7 Ketones: Ketone bodies
should not detected in normal urine with this test. Fasting or
starvation diets may cause positive results. In known pathological
conditions such as diabetes, the presence of ketones may be useful
as an index of metabolic status. 8 Urobilinogen: Concentrations are
usually greater in the afternoon than during the remainder of the
day. Values up to 1 mg/dL are usually considered normal.13

9 Bilirubin: In normal urine, bilirubin should not be detectable
with this test. However, the test is very sensitive to bili-rubin
(0.5 mg/dL will produce positive results), and any positive
reaction indicates that further diagnostic evaluation of the
patient is needed. Blood: Erythrocyte excretion up to 5 Ery/L may
be expected in normal urine. 17, 18 Levels above this may require
further evaluation of the patient.

12

H.

Quality Control Procedure

Policy1 Quality control testing will be performed with a minimum
of two (2) quality control solutions according to your facili-tys
policy. 2 It is required to run a positive and negative control
daily and when a new vial of test strips is opened (including every
lot change). Values obtained for these controls should fall within
the limits established by the laboratory or the control
manufacturer. 3 Check the appropriate boxes for your facilitys
additional quality control frequency, being sure to meet all
standards of your regulatory agencies. 1q Each ________ (when? day,
shift, etc.). 2q When the test strips have been exposed to extreme
heat, humidity or cold. 3q When test results contradict clinical
symptoms. 4q As a way of checking operator competency. 5q Other
______________________________________________________________________________________.
4 If a quality control test result falls within the acceptable
control range, it is acceptable to proceed with patient testing. 5
If a quality control test result falls outside of the acceptable
control range, repeat the test with a fresh Chemstrip urine test
strip. Check the stability of the control being used. The problem
must be corrected before proceeding with patient testing. 6 Any
quality control result that falls outside of the acceptable control
range, along with any corrective action to restore that result to
acceptable range, must be recorded in the Urinalysis Quality
Control Log or other quality control log. 7 The controls should be
stored at the proper temperatures according to the manufacturers
recommendations. 2 Any outdated test strips or controls will be
discarded. 3 The urine test strip lot number and expiration date
are found on the label of each vial of Chemstrip urine test strips.
This information should be recorded in the Urinalysis Quality
Control Log or other quality control log. 4 Chemstrip urine test
strips must be stored at temperatures below 30C (86F). Do not
freeze. Teststrips are stable until the expiration date. Test
strips must be stored in the same capped vial in which they were
packaged, and the vial cap must be immediately replaced after
removal of a test strip.

5

Urine controls recommended for use with the Urisys 1100 Urine
Analyzer are KOVA-Trol and KOVA Liqua-Trol (HYCOR Biomedical Inc.),
the Dipper Urine Dipstick Control (Quantimetrix) and Liquichek
(BIORAD). Refer to

Section V. Appendix for more information about these controls. 6
Insert your facilitys quality control preparation information after
this page.13

Procedure1. The following equipment is needed for quality
control testing: Urisys 1100 Urine AnalyzerChemstrip urine test
strips Commercially prepared urinalysis control

Disposable latex gloves (if required by facility) Laboratory
coat (if required by facility) Absorbent paper 2. Prepare controls
according to the manufacturers instructions. 3. Check the
expiration date on the Chemstrip urine test strip vial prior to
testing. 4. The Urisys 1100 Urine Analyzer is ready for measurement
as long as valid calibration values are stored inthe ana-lyzer.
Refer to Section I.D. Calibration of the Urisys 1100 Urine Analyzer
of this manual.

5.

Verify the test strip tray is clean of any residue. If there is
residue on the tray, refer to Section II. Preventive Maintenance of
this manual for the cleaning procedure. Any residue on the test
strip tray may result in inaccurate results.

6. Remove the cap from the test strip vial and remove one
Chemstrip urine test strip. 7. Dip the test strip for one second in
the control. Draw the edge of the test strip along the rim of the
container. Gentlytouch (one second) the long edge of the test strip
to a piece of absorbent paper to remove any excess control.

8. If the analyzer is in Standby mode, press START to return to
Ready-to-Measure mode. The test strip tray and the retaining bar
must be in the open position. Place the test strip, with the pads
facing upward, onto the test strip tray and insert the front edge
of the strip under the plastic clip. 9. Press the START button. You
will hear a beep and then the tray advances slightly and the
retaining bar closes. First the gray reference pad located on the
test strip tray is read. 10.If the test strip is not lined up
straight on the test strip tray, gently move it until it is
properly lined up

under the retaining bar. Be careful not to move the tray.

11.

Approximately 60 seconds after the START key is pressed, all
test strip pads will be read. The results will

print and the next sample number appears on the display.

12.

The test strip tray will return to the start position and the
retaining bar will open. Remove the used test strip

and wipe the test strip tray as needed with a lint-free cloth to
remove any residue. Refer to Section II. Preventive Mainte-nance of
this manual for the cleaning procedure.

13.

Properly dispose of the control solution and test strip.14

I.

Documentation of Quality Control Results

Policy1 Quality control records are retained for a minimum of
two years. 2 The date, time, initials of the operator, and quality
control result are recorded in the Urinalysis Quality Control Log
or other quality control log. The log should also include the lot
number and expiration date of the control solutions and urine test
strips. 3 Any quality control result that falls outside the
acceptable control range, along with any corrective action to
restorethat result to acceptable range, is recorded in the
Urinalysis Quality Control Log or other quality control log.

4 An appropriate authority or an appointed individual reviews
the Urinalysis Quality Control Log for completenessand notes any
trends that could indicate potential problems. Such trends include
gradual drifting of values, sudden shifts in urine control values
while using the same lot of strips, and operator performance. The
log is reviewed

___________ (when? weekly, monthly, quarterly). 5 An audit trail
should exist to link the control test values to the patient test
values performed that day by listing theappropriate Urisys 1100
Urine Analyzer, Chemstrip urine test strip and control solution lot
number used.

6 Insert your facilitys policy for who is responsible for the
performance and documentation of quality
control._________________________________________________________________________________________________
_________________________________________________________________________________________________
_________________________________________________________________________________________________
_________________________________________________________________________________________________
_________________________________________________________________________________________________
_________________________________________________________________________________________________

15

J.

Limitations of the Procedure

Please reference the most recent Chemstrip urine test strip
package insert for modifications in the limitations of proce-dure.
1 Specific Gravity: The chemical principle of the test may cause
slightly different results compared with otherspe-cific gravity
methods when elevated amounts of certain constituents are present.
Glucose and urea concentrations greater than 1% may cause a low
specific gravity reading relative to other methods. In the presence
of moderate amounts of protein (100-500 mg/dL) or ketoacidosis,
readings may be elevated.

2 Leukocyte: This test is not affected by erythrocytes in
concentrations up to 10,000/L or by bacteriacommon in urine. Do not
collect specimens in containers that have been cleaned with strong
oxidizing agents. Do not use pre-servatives. The drugs cephalexin
and gentamicin have been found to interfere with this test.
Nitrofurantoin colors the urine and thus causes interference with
visual interpretation of the test strip. High levels of albumin
(>500 mg/ dL) in the urine may interfere with the test
results.

3 Nitrite: Large amounts of ascorbic acid (see under glucose)
decrease the sensitivity of the test. False positive read-ings may
be produced by medication that colors the urine red or that turns
red in an acid medium (e.g., phenazo-pyridine). 4 Protein: False
positive results may be found: In strongly alkaline urine (pH of 9
or higher). During therapy with phenazopyridine. When infusions of
polyvinylpyrrolidone (blood substitutes) are administered. When
residues of disinfectants containing quaternary ammonium groups or
chlorohexidine are present in the urine container. 1 Glucose: The
effect of ascorbic acid (vitamin C) retained in the urine due to
ingestion of vitamin tablets,antibiotics, or fruit juices has been
eliminated at glucose concentrations of 100 mg/dL and above so that
false negative read-ings rarely occur, even at high concentrations
of ascorbic acid. False positive readings may be produced by
strongly oxidizing cleaning agents in the urine container.

2 Ketone: Red-orange to red color shades, which are readily
distinguished from the colors obtained with ketone bodies, can be
produced by phenylketone or phthalein compounds administered for
liver and kidney function tests. 2-

Mercaptoethane sulphonate sodium (MESNA) or other
sulfhydryl-containing compounds may cause false positive results.
21 3 Urobilinogen: The total absence of urobilinogen cannot be
detected. Most urine specimens give a slight pink reaction. This
test gives the same color reaction with urobilinogen as with
stercobilinogen; however, the differentiation is not of diagnostic
importance. Urine from patients treated with phenazopyridine may
show a false positive reaction.

Nitrite concentrations above 5 mg/dL or formalin concentrations
above 200 mg/dL (used as a preservative) may cause a decrease in
color reaction.

16

1 Bilirubin: Large amounts of ascorbic acid present in the urine
following the ingestion of medication containingvita-min C or fruit
juices lower the sensitivity of the test. In case of doubt, repeat
test on urine voided at least 10 hours after the last
administration of vitamin C. Elevated concentrations of nitrite, as
in urinary tract infections, may result in lower bilirubin values.
Large amounts of urobilinogen in the urine affect the color change
of the bilirubin test, but not enough to give a positive result.
False positive results may be produced by medications that color
the urine red or turn red in an acid medium (e.g.,
phenazopyridine).

2 Blood: False negative readings are obtained when formalin is
used to preserve the urine. Nitrite in excess of 10 mg/ dL in the
urine (which is rare in urinary tract infections) delays the
reaction. False positive results can be produced by residues of
strongly oxidizing cleaning agents in the urine container. Urine
from menstruating females occasion-ally yields a positive result.
This test has not been found to be affected by the ingestion of
reasonable quantities of ascorbic acid.

17

II.

Preventive Maintenance

Policy Cleaning the Analyzer1 Clean and disinfect the exterior
of the Urisys 1100 Urine Analyzer by using a cloth dampened with a
suitabledisin-fectant such as 10% bleach or isopropyl alcohol. Be
sure that no liquid enters the analyzer.

2 Clean the test strip tray every day.

Procedure1. Turn off the power. 2. Remove the test strip tray.
3. Rinse the tray under running water. 4. Remove any crystalline
deposits, especially those contaminating the retaining bar
mechanism, with a soft brush. 5. Wipe down the test strip tray with
isopropyl alcohol or 10% bleach. 6. Dry with a soft, lint-free
cloth. 7. Install the test strip tray by holding the tray opposite
the side with the gray reference pad and inserting the tray into
the slot below the function keys. Do not touch the gray reference
pad. 8. Switch on the instrument. During the self-check process,
the system will verify that the reference pad is in suitable
condition for reading test strips. If not, an error message will be
displayed.

Policy Replacing Printer PaperReplace the printer paper the day
it runs out, following the instructions in Section 4.2 of the
Urisys 1100 Operators Manual. This will ensure a paper print-out of
calibration results will be available the next day if calibration
is performed upon instrument start up.

18

Policy Documentation and Replacement1 Any maintenance,
calibration or replacement is documented on the Preventive
Maintenance Log. 2 Replaceable parts are available. They can be
ordered from your local Roche Diagnostics distributor or are
available from __________________(location in your facility).
Replaceable parts for the Urisys 1100 Analyzer are:Replaceable Part
Test strip tray — Type C for Chemstrip 10MD Test strip tray Type N
for Chemstrip 5 OB/Chemstrip 7 AC Adapter Power cord Reference pads
Thermal paper Interface connection cable Keyboard Barcode reader
w/o trigger Barcode reader cable Catalog Number 3666735 3666913
4340647 4340612 1907131 3666751 1906186 1248693 ??? ???

#See your Operators Manual to determine which test strip tray is
in your analyzer.

1 If staff are unable to correct a problem with the Urisys 1100
Urine Analyzer, they are instructed to
contact_______________(location in your facility) or call Roche
Diagnostics Technical Service Center at 1-800-428-4674.

2 The appointed individual reviews the Preventive Maintenance
Log for completion __________________(when? weekly, monthly,
quarterly). 3 Insert your policy for who is responsible for
performing and documenting preventive maintenance.Name
Title_______________________________________________
_______________________________________________
_______________________________________________
_______________________________________________
_______________________________________________
_______________________________________________
_______________________________________________
_______________________________________________
_______________________________________________
_______________________________________________

19

III. Infection Control GuidelinesPolicy1 Because of the
potentially hazardous nature of handling urine and the possibility
of its contamination with blood, it is recommended that disposable
latex gloves and laboratory coats be used when collecting specimens
and perform-ing test procedures. Consult your facilitys infection
control policy. 2 Disposable latex gloves and laboratory coats are
to be removed and hands washed thoroughly with soapand water after
completing the test procedure and prior to handling equipment not
related to the procedure.

3 Urine specimens should be handled at Biosafety Level 2 as
recommended for any potentially infectious material in the Centers
for Disease Control/National Institutes of Health manual, Biosafety
in Microbiological and Biomedical Laboratories, 1988. Universal
precautions may apply if the urine is contaminated with blood or if
required by the infection control policy of your facility. 24 4 If
a spill should occur, disinfect the area with a 1:10 bleach
solution (1 part bleach plus 9 parts water) or follow the infection
control procedures of your facility.

20

IV. Operator Certification/RecertificationPolicy1 Operators
receive appropriate certification to perform tests with the Urisys
1100 Urine Analyzer according to your facilitys policy. 2
Certification is documented and maintained on the Operator
Certification Log and Skills Checklist. A Knowledge Test is also
provided. 3 Only certified operators may use the Urisys 1100 Urine
Analyzer. 4 Operator competency checks (recertification) will be
performed yearly and recorded on the Operator Certification Log and
Operator Competency Log.

Procedure Operator CompetencyThe following procedure may be used
to certify/recertify your operators and check their competency on
the use of the Urisys 1100 Urine Analyzer. Note: A valid
calibration is required before performing the following within-run
precision. Within-Run Precision 1. The following equipment is
assembled prior to testing: Urisys 1100 Urine Analyzer Chemstrip
urine test strips Quality control material1, 2, or 3 levels
(according to your facilitys policy) prepared according to the
manufac-turers instructions Disposable latex gloves (if required by
facility) Laboratory coat (if required by facility) Absorbent paper
Operator Competency Log 2. Run control 20 times consecutively on
the Urisys 1100 Urine Analyzer. Refer to Section I.H. Quality
Control Proce-dure for instructions. 3. Record results on the
Operator Competency Log. 4. Determine the result that occurs most
frequently (mode) for each parameter and record the result.21

5. Determine the color block variation (plus or minus the number
of color blocks from the mode) for each parameter in the run of 20.
Record the result for each parameter. 6. The color block variation
(number of color blocks away from the mode) for each chemistry of
the 20 analyses should be no greater than one color block. Refer to
Section 1.H. Quality Control Procedure if the color block variation
exceeds plus or minus one. Example 1: If 20 consecutive glucose
results produce 20 results of 100 mg/dL, the mode is 100 mg/dL and
the color block variation is 0. This is acceptable
performance.Example 2: If 20 consecutive glucose results produce 15
results of 100 mg/dL and 5 results of 250 mg/dL, the mode is 100
mg/dL and the color block variation is + one color block. This is
acceptable performance.

Example 3: If 20 consecutive glucose results produce two results
of 50 mg/dL, 16 results of 100 mg/dL and two results of 250 mg/dL,
the mode is 100 mg/dL and the color block variation is + one and —
one color block. This is acceptable performance.Example 4: If 20
consecutive glucose results produce two results of normal, 16
results of 100 mg/dL and two results of 250 mg/dL, the mode is 100
mg/dL and the color block variation would be + one and — two color
blocks. This is unacceptable performance.

Control Recovery1. Record the control package insert acceptable
ranges for the Urisys 1100 Urine Analyzer on the Operator
Compe-tency Log. The Urisys 1100 results should be compared to the
visual acceptable ranges if the Urisys 1100 Analyzer is not
referenced on your control package insert. 2. Compare the
acceptable ranges stated in the package insert to the results
obtained from the within-run precision step 4. 3. The mode results
should fall within the acceptable control ranges. Refer to Section
I.H. Quality Control Procedure for instructions if the results fall
outside the acceptable control ranges.

GuidelinesInsert your policy for who is responsible for training
and documenting operator certification / recertification with the
Urisys 1100 Urine
Analyzer.___________________________________________________________________________________________________
___________________________________________________________________________________________________
___________________________________________________________________________________________________

22

References1. Kolthoff, I. Acid-Base Indicators. McMillan Co.,
New York, 1937, p. 171. 2. Free, H., G. Collins and A. Free.
Triple-test Strip for Urinary Glucose, Protein and pH, Clin Chem,
1960, 6:352. 3. Griess, P., Notes on the Paper of Weselsky and
Benedikt. Some Azo Compounds. Ber. Dtsch. Chem. Ges., 1879, 12:426.
4. Weltmann, O., Method for the Simple Detection of Urinary Tract
Infections. Wien. Med. Wschr, 1922, 72:618. 5. Fuchs, T. and G.
Gutensohn. Value and Limitation of the Nitrite Test in Diagnosis of
Pyelonephritis. Dtsch. Med. J., 1967, 10:343. 6. Srensen, S. The
Measurement of the Hydrogen Ion Concentration and Its Importance
for Enzymatic Processes. Bio-chem. Z., 1909, 21:131. 7. US Patent
No. 4013416. 8. Gyure, W. L. Comparison of Several Methods for
Semiquantitative Determination of Urinary Protein. Clin. Chem,
1977, 23:876. 9. Keston, A. Abstracts of papers presented at the
129th meeting of the American Chemical Society, Dallas, April,
1956, p. 31c. 10. 11. 12. 13. 14. 15. 16. 17.Comer, J.
Semiquantitative Specific Test Paper for Glucose in Urine. Anal.
Chem., 1956, 28:1748. Legal, E. A New Acetone Reaction and its
Applicability for the Examination of Urine. Chem. Centr., 1883,
14:652. Chertack, M. and J. Sherrick. Evaluation of A Nitroprusside
Dip Test For Ketone Bodies. J. A. M. A., 1958, 167:1621.

Kutter, D. et al. Usefulness of a New Test Strip for Detecting
Urobilinogen in Urine. Dtsch. Med. Wschr., 1973, 98:112.

With, T. Bile Pigments, Chemical, Biological and Clinical
Aspects. Academic Press, New York, 1968, p. 492. Cook, M., et al.
The Detection of Blood in Urine. Am. J. Med. Tech., 1956, 22:218.
Leonards, J. Simple Test For Hematuria Compared With Established
Tests. J. A. M. A., 1962, 179:807. Braun, J. and W. Straube. A New
Rapid Test For Diagnosing Microhematuria, Compared With Results
Of

Microscopic Examination. Dtsch. Med. Wschr., 1975, 100:87.

18.

Kutter, D. et al. Usefulness of a New Test Strip for the
Detection of Erythrocytes and Hemoglobin in Urine.

Dtsch. Med. Wschr., 1974, 99:2332.

19.

Brhl, P. et al. Clinical Experience Gained with a Test Strip
Used to Screen for Erythrocytes and Hemoglobinuria.

Therapiewoche, 1976, 26:5193.

20.

NCCLS. Protection of Laboratory Workers from Infectious Disease
Transmitted by Blood and Tissue.23

NCCLS Doc. M29-P, 7, 9, May, 1985, 342-347.

21.

Csako, G. False Positive Results for Ketone with the Drug Mesna
and Other Free-Sulfhydryl Compounds. Clin.

Chem., 1987, 33/2:289.

22. Henry, J.B. et al. Clinical Diagnosis and Management by
Laboratory Methods, 17th ed. Saunders Philadelphia, 1984, 394;1441.
23. Czerwinski, A. W., et al. Further Evaluation of the Griess Test
to Detect Significant Bacteriuria.Amer. J. Obstet. Gynec., 1971,
110:677.

24. Centers for Disease Control/ National Institutes of Health.
Biosafety in Microbiological and BiomedicalLaboratories, 1988.

24

V. AppendixInstructions for Collections of a Midstream UrineWhen
examining urine specimens, every precaution must be taken to avoid
contamination. Therefore, make sure your patients follow the
instructions below carefully so that reasonable test results are
obtained.

It is important to note that some cleansing towelettes may use
soaps that contain oxidizing agents. Oxidizing agents may interfere
with some parameters on the urine test strips. Therefore, it is
extremely important that thorough rinsing take place after
cleansing the genitals.

Procedure1. Do not open the specimen container until immediately
prior to use. 2. Procedure Female 1 Kneel or squat over a bedpan or
stand astride a toilet bowl. 2 Separate labia minor. 3 Cleanse
meatus (opening of urethra) three times. 4 Rinse area with sterile,
water-saturated sponge. Do not dry. 5 Void forcibly, allowing
initial stream of urine to pass into the lavatory. 6 Collect
midstream in sterile container. Male 1 Cleanse glans three times. 2
Rinse area with sterile, water-saturated sponge. Do not dry. 3 Void
forcibly, allowing initial stream of urine to pass into the
lavatory. 4 Collect midstream in sterile container.

25

Infant 1 Cleanse genitalia three times. 2 Rinse area with
sterile, water-saturated sponge. Do not dry. 3 Supporting infant in
a face down position, stimulate urination by stroking paraspinal
muscles. 4 If infant fails to void, place sterile bag over
genitals. 5 If infant does not void within 45 minutes, re-prep the
area and apply a new bag. 6 Collect urine in a sterile container. 7
Do not allow the container to touch the body. 4. Close the
container and present it immediately for urinalysis.

26

Routine Urinalysis Controls Compatible with the Urisys 1100
Urine AnalyzerSeveral commercial controls are available. Controls
may vary in number of levels or components, necessity for
reconsti-tution or ready to use, type and volume of container, and
usefulness as a control for microscopic examination. When selecting
a control, consider the above-mentioned variables to identify the
control most suitable for your facilitys needs. Controls typically
can be ordered through medical/surgical supply distributors or
directly from the manufacturer.

Refer to the following table to determine which control best
meets the needs of your facilitys quality control
require-ments.Urine Controls Chart Brand Name KOVA-Trol Urinalysis
Control Manufactur er KOVA Liqua-Trol Urinalysis Control HYCOR
Biomedical Inc. www.hycorbiomedical.c om 7272 Chapman Ave. Garden
Grove, CA 92641 The Dipper Urine Dipstick Control Liquichek Routine
Urine Chemistry Control BIO RAD

Website Address

HYCOR Biomedical Inc. www.hycorbiomedical.c om 7272 Chapman Ave.
Garden Grove, CA 92641

Quantimetrix Corporation www.4qc.com 2005 Manhattan Beach Boulev
ard Redondo Beach, CA 90278 800-624-8380 310-536-0006 800.845.1834
[email protected]

www.bio-rad.com 4000 Alfred Nobel Dr Hercules, CA 94547

Toll-free No. Phone No. Fax No. Product Informatio n Requests
Distributio n

800-382-2527 714-895-9558 714-933-3222 http://www.hycorbiomedic
al. com/site/inforequest.ht ml

800-382-2527 714-895-9558 714-895-6920 http://www.hycorbiomedic
al. com/site/inforequest.ht ml

800-224-6723 510-724-7000 510-741-6373 [email protected]

Cardinal, Fisher, PSS, McKesson, Owens & Minor, Henry
Schein

Cardinal, Fisher, PSS, McKesson, Owens & Minor, Henry Schein
2: Normal Abnormal

Number of Levels

3: Negative Norm Low Abnormal High Abnormal/ High Abnormal
w/urob. Reconstitution 4 x 15 mL 4 x 60 mL 10 x 60 mL

Direct, online thru website , Cardinal Health, Fisher, Infol
Labsco, ab, McKesson, Owens & Minor, PSS 2: Nor mal
Abnormal

Direct, online catalog on website, Cardinal, PSS, Labsco 2:
Level 1Negative/Norm. Level 2Positive/Abnormal Ready to use 10 x 10
mL

Preparatio n Package Size

Ready to use 3 x 15 mL

Ready to use 6 x 15 mL

Stability / Unopened Stability / Opened Microscopi c Values

Until exp. date on vial (18mo.) 5-7 days after recon 4 mo.
frozen Yes

Until exp. date on vial Until exp. date on vial Yes

Until exp. date on vial 90 days 2-8C

Until exp. date on vial 7 days 2-8C

No

No

27

VI. Log SheetsThis section contains the following blank log
sheets that may be copied and used for documentation for the Urisys
1100 Urine Analyzer in your facility. Operator Certification Log
for recording the names of trained Urisys 1100 operators and
tracking yearly competency checks. Operator Competency Log for
recording yearly competency checks for each operator, withinrun
precision data, and control recovery data.Reagent Log for recording
the date received, lot numbers and expiration dates of Chemstrip
urine test strips,

Chemstrip Calibration Strips and controls. Urinalysis Report
Form for recording patient results. Quality Control Log for
recording quality control information. Preventive Maintenance Log
for recording the dates on which maintenance was performed.
Temperature Log (2) for recording Urisys 1100 Urine Analyzer
operating temperatures and Chemstrip urine test strip storage
temperatures. Knowledge Test for written documentation of operator
certification.Skills Checklist for documenting operator skills
while training on the Urisys 1100 Urine Analyzer

28

Operator Certification LogUrisys 1100 Urine AnalyzerDate of
Initial Certification Operator ID No. Competency Checks Date
Observer / Reviewer Initials / Date

2008 Roche Diagnostics. All rights reserved. COBAS, Urisys 1100
and CHEMSTRIP are trademarks of Roche.29

Operator Competency LogUrisys 1100 Urine AnalyzerOperator
Name:___________________________________________________________
Chemstrip Cat. No. Lot No.: ______________________________
__________________ Control Name and Lot No.:
Level:_________________________ __________________ Within-Run
PrecisionSG 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 Mode
Color block variation pH LEU NIT PRO GLU KET

Date:___________________ __ Exp. Date:_________________ Exp.
Date:_________________

UB G

BILI

BLD

Note: The color block variation should be no greater than +/-
one color block from the mode for acceptable perfor-mance.

2008 Roche Diagnostics. All rights reserved.

COBAS, Urisys 1100 and CHEMSTRIP are trademarks of Roche.30

Operator Competency LogUrisys 1100 Urine AnalyzerControl
RecoveryControl Package Insert Ranges Urisys 1100 Urine Analyzer
Mode Result from Within Run Precision

SG pH LEU NIT PRO GLU KET UBG BILI BLD

Note: Reference the visual acceptance range if the Urisys 1100
Urine Analyzer is not referenced on your control pack-age
insert.

2008 Roche Diagnostics. All rights reserved. COBAS, Urisys 1100
and CHEMSTRIP are trademarks of Roche.31

Reagent LogUrisys 1100 Urine AnalyzerChemstrip Urine Test Strips
No. Lot Vials No. Chemstrip Urine Analyzer Calibration Strips No.
Lot Exp. Vials No. Date Controls No. Vials Lot No. Exp. Date

Date Recd

Exp. Date

Da te Re cd

Date Recd

2008 Roche Diagnostics. All rights reserved. COBAS, Urisys 1100
and CHEMSTRIP are trademarks of Roche.32

Urinalysis Report FormUrisys 1100 Urine AnalyzerPatient Name:
________________________________________________________________________________________

Age: ______________________________

M

F

Physicians Name:
_____________________________________________________________________________________

Collection Date: __________________ Physical Examination Color:
Appearance: Chemical Examination Specific Gravity pH Leukocytes
Nitrite Protein Glucose Ketones Urobilinogen Bilirubin Blood
Comments: colorles s clear

Test Date: _______________________ yello w hazy

Operators Initials: __________________

amber cloudy

other turbid

1.000 5 neg neg neg norm neg norm neg neg

1.005 6 25 pos trace 50 15 1 1 trace

1.010 6.5

1.015 7

1.020 8

1.025 9

1.030

75 500 (any pink color is considered positive) 30 100 50 4 3 50
100 250 150 8 6 250 >12 500 >1000

____________________________________________________________________________________________________
____________________________________________________________________________________________________

Attach the Patient Report printout here if required by your
facility.2008 Roche Diagnostics. All rights reserved. COBAS, Urisys
1100 and CHEMSTRIP are trademarks of Roche.33

Quality Control LogUrisys 1100 Urine AnalyzerName of control
solution used by your facility:
______________________________________________________________

Control Lot No.: __________________________________ Exp. Date:
______________Chemstrip Cat. No.:
___________________________________________________________________________________

Chemstrip Lot No.: ________________________________ Operators
Initials: ________________________________Dat e Lev el 1 Lev el 2
Lev el 1 Lev el 2 Lev el 1 Lev el 2 Lev el 1 Lev el 2 Lev el 1 Lev
el 2 Lev el 1 Lev el 2 Lev el 1 Lev el 2 Lev el 1 Lev el 2 Lev el 1
Lev el 2 Lev el 1 Lev LE U PR O G L U

Exp. Date: _____________

SG

pH

NIT

KE T

UB G

BILI

BL D

Yes/ No

Initi als

Correcti ve Action

el 2 Lev el 1 Lev el 2 Lev el 1 Lev el 2

Note: Reference the visual acceptable range if the Urisys 1100
Urine Analyzer is not referenced on your control pack-age
insert.

2008 Roche Diagnostics. All rights reserved. COBAS, Urisys 1100
and CHEMSTRIP are trademarks of Roche.3 4

Preventive Maintenance LogUrisys 1100 Urine AnalyzerCheck the
box if you have performed the task. Date and initial the top of the
column.Date

Initials

1. Adequate urine test strip supply available.

2. Urine test strips within expiration date.

3. Adequate supply of calibration strips.

4. Adequate supply of controls available.

5. Controls within expiration date.

6.

Clean exterior of analyzer with 10% bleach solution.

7. Clean the tray of analyzer with 10% bleach solution.

8. Calibrate the analyzer. Perform weekly.9. Replace printer
paper on the day it runs out.

10.

Operators

manual and test strip package insert available.

Refer to the Urisys 1100 Urine Analyzer Operators Manual for
specific procedural instructions.

2008 Roche Diagnostics. All rights reserved. COBAS, Urisys 1100
and CHEMSTRIP are trademarks of Roche.35

Temperature LogUrisys 1100 Urine AnalyzerLocation:
______________________________________________________ Year:
_________________________________________________________
Acceptable Range (C): __________________________________________Fe
b Ma r Ma y Jun e Jul y Au g Se pt No v D e c

Jan 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23
24 25 26 27 28 29 30 31

Apr

Oct

2008 Roche Diagnostics. All rights reserved. COBAS, Urisys 1100
and CHEMSTRIP are trademarks of Roche.

36

Temperature LogChemstrip Urine Test StripsCat. No.
_______________________________________________________ Location:
______________________________________________________ Year:
_________________________________________________________
Acceptable Range (C): __________________________________________Fe
b Ma r Ma y Jun e Jul y Au g Se pt No v D e c

Jan 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23
24 25 26 27 28 29 30 31

Apr

Oct

2008 Roche Diagnostics. All rights reserved. COBAS, Urisys 1100
and CHEMSTRIP are trademarks of Roche.

37

Knowledge TestUrisys 1100 Urine AnalyzerName:
___________________________________________ Date:
____________________________________________ ID No.:
___________________________________________ Unit:
_____________________________________________

Mark T if the statement is true and F if the statement is false.
_____ 1. You must check the expiration dating on the vial each time
you perform a patient or quality control test. _____ 2. Dip the
Chemstrip urine test strip briefly (no longer than 1 second) in the
urine sample. _____ 3. Strong oxidizing cleaning agents interfere
with the blood patch results. _____ Correct placement of the
Chemstrip urine test strip in the tray of the analyzer is necessary
to obtain 4. accurate results. _____ 5. It is necessary to bring
refrigerated samples to room temperature before testing. _____ 6.
The sample should be in sufficient volume to allow all test pads to
be completely wetted. _____ Running the side of the Chemstrip urine
test strip along the rim of the container removes excess 7. sample.
_____ 8. If you do not obtain a successful calibration, the
analyzer will still process samples. _____ 9. A positive nitrite
test is not normal in fresh, clean-catch midstream urine specimens.
_____ 10.Urine residue on the tray of the analyzer may result in
inaccurate results. _____ 11.Green spots on the blood patch are
indicative of unlysed erythrocytes.

2008 Roche Diagnostics. All rights reserved. COBAS, Urisys 1100
and CHEMSTRIP are trademarks of Roche.38

Fill in the blanks. 12. 13. 14. The specimen should be tested
within ___________ hour(s) of collection, otherwise, refrigerate it
in a closed container. Replace the _____________________ to avoid
deterioration of the test strips.When using Chemstrip 10MD Test
Strips, the Urisys 1100 Urine Analyzer must be calibrated every
________

days. 15. 16. 17. Reasonable amounts of ascorbic acid do not
affect the ________ test. The specimen must be thoroughly
________________________, as red cells sink to the bottom and could
cause false positive results. Rinse the test strip tray with a
suitable disinfectant ________ (when?).

2008 Roche Diagnostics. All rights reserved. COBAS, Urisys 1100
and CHEMSTRIP are trademarks of Roche.39

Answer Key 1. 2. 3. 4. 5. 6. 7. 8. 9. 10. 11. 12. 13. 14. 15.
16. 17. T T T T T T T F T T T one vial cap seven blood or glucose
mixed daily

2008 Roche Diagnostics. All rights reserved.COBAS, Urisys 1100
and CHEMSTRIP are trademarks of Roche.

4 0

Skills ChecklistUrisys 1100 Urine AnalyzerThe trainer should
check each activity as it is demonstrated. All activities must be
completed before the trainee is certi-fied to use the Urisys 1100
Urine Analyzer. Specimen Collection 1. User assembles specimen
collection supplies 1q Specimen container 2q Cleansing towelette 3q
Water-saturated sponge 3. User reviews specimen collection 1q
States patient preparation steps 2q Explains specimen storage and
stability 3q Describes clean-catch, midstream urine technique
Testing Procedure 1. User assembles testing supplies 1q Urisys 1100
Urine Analyzer 2q Chemstrip Urine Test Strips 3q Chemstrip Urine
Analyzer Calibration Strips 4q Patient specimen 5q Disposable latex
gloves and laboratory coat 6q Absorbent paper 2. User preparation
1q Checks expiration date on test strip vial 2q Puts on disposable
latex gloves and laboratory coat

2008 Roche Diagnostics. All rights reserved. COBAS, Urisys 1100
and CHEMSTRIP are trademarks of Roche.41

3. Sample preparation 1q States if refrigerated, bring sample to
room temperature 2q Mixes sample by swirling capped container
several times 4. Calibration (when using Chemstrip 10MD or
Chemstrip 10UA Test Strips) 1q Removes one Chemstrip urine analyzer
calibration strip 2q Does not touch elevated gray areas on strip 3q
Places calibration strip(pad side up) onto the test strip tray 4q
Presses START button 5q Documents calibration on the Preventive
Maintenance Log 5. Testing 1q Removes one Chemstrip urine test
strip 2q Replaces vial cap immediately 3q Ensures analyzer test
strip tray is clean 4q Briefly dips test strip vertically into
specimen 5q Draws strip edge along rim of container to remove
excess urine 6q Touches strip to absorbent paper 7q Places the test
strip (pad side up) onto the test strip tray 8q The handle end of
the strip should be held by the clip at the insertion slot 9q
Obtains results from the printout 10q Removes test strip 11q Wipes
tray with dry lint-free cloth. If there is any residue on the tray,
follows proper maintenance as outlined in the Urisys 1100 Urine
Analyzer Operators Manual.

2008 Roche Diagnostics. All rights reserved. COBAS, Urisys 1100
and CHEMSTRIP are trademarks of Roche.42

6. Results 1q Documents results as appropriate for your facility
7. Quality control 1q States when to perform QC tests 2q Performs
test like routine urine. 3q Documents results 4q Reviews procedure
if the test results fall outside the acceptable range 5q If problem
persists, calls Roche Diagnostics Technical Service Center at
1-800-428-4674 8. Infection control 1q Properly disposes of
specimen, used test strips and container 2q Cleans and
decontaminates the work area according to infection control policy
3q Removes and disposes of disposable latex gloves

____________________________________________________________________________________________________

Operator Signature

Date

____________________________________________________________________________________________________

Trainer Signature

Date

Contact your Roche Diagnostics Account Manager for training
certificates.

2008 Roche Diagnostics. All rights reserved. COBAS, Urisys 1100
and CHEMSTRIP are trademarks of Roche.43

VII. Regulatory Requirements

2008 Roche Diagnostics. All rights reserved.COBAS, Urisys 1100
and CHEMSTRIP are trademarks of Roche.

4 4

VIII.Product Information

2008 Roche Diagnostics. All rights reserved.COBAS, Urisys 1100
and CHEMSTRIP are trademarks of Roche.4 5

Roche Diagnostics Corporation

9115 Hague Road Indianapolis, IN 46256www.poc.roche.com
www.diavant.com

Cat. No. 3755541 REF 0 3755541001

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