UN-Series With Novus Chemistry Analyzer CLSI Rev3

Sysmex UN-Series™
Automated Urinalysis Solution

with Siemens CLINITEK Novus® Automated Urine
Chemistry Analyzer
CLSI Procedure
Document Number: 1519–LSS

Rev 3
Date: July 2021
Classified as Internal
AUTOMATED URINALYSIS ON THE SYSMEX UN-SERIES
Disclaimer: This procedure is to be used only as an EXAMPLE. It is SOLELY the

responsibility of the laboratory to review, edit, and update their procedures and make the
changes that are specific to and required by their laboratory. Sysmex America, Inc. will
not be held liable.
Sysmex America Inc.
DATE IMPLEMENTED
Date: _______________
Replaces method of Date: _____________________________
Prepared by: _______________________________________Date_____________________

Signature/Title
Approved by: _______________________________________Date_____________________
Signature/Title
Adopted by: ________________________________________Date____________________
Signature/Title
ANNUAL REVIEW
REVIEWED_________________________________________ ___________________________
Signature/Title Date
REVIEWED_________________________________________ ___________________________
REVIEWED_________________________________________ ___________________________
REVIEWED_________________________________________ ___________________________
REVIEWED_________________________________________ ___________________________
REVISED___________________________________________ ___________________________
REVISED___________________________________________ ___________________________
REVISED___________________________________________ ___________________________
REVISED___________________________________________ ___________________________
REVISED___________________________________________ ___________________________
Supersedes: Procedure Titled_________________________________________________________________

Sysmex UN-Series CLSI Procedure
Document Number: 1519-LSS, Rev 3. July 2021 Page 2 of 65
AUTOMATED URINE ANALYSIS ON THE SYSMEX UN-SERIES
I. PRINCIPLE
The Sysmex UN-Series are integrated, automated urinalysis solutions used for the in
vitro analysis of human urine. The series is designed to automate urine sediment testing
by utilizing the Siemens CLINITEK Novus® Automated Urine Chemistry Analyzer, UF-
5000TM Automated Urine Particle Analyzer, the UD-10TM Automated Urine Particle Digital
Imaging Device, and Urinalysis Data Manager (UDMTM),
The UN systems may be a combination of the Siemens CLINITEK Novus, UF-5000 and
UD-10 or multiple identical analyzers (Novus, UF-5000 or UD-10). You may delete the
analyzer that is not present in your laboratory configuration when working with
this document.
The TH-11™ Urine Sample Decapper Unit is a device that automatically decaps urine
sample tubes and may be attached to your UN system. TH-11 is connected to the CV-
11 that is connected to the Fully Automated Urine Chemistry Analyzers, Siemens
CLINITEK Novus, or to a CV-11 that is connected to a Fully Automated Urine Particle
Analyzer, UF-5000, and automatically decaps sample tubes before feeding them to the
analyzers. The TH-11 is intended to eliminate manual decapping work, streamline the
urinalysis workflow, and reduce the risk of infection. You may delete the procedures
for the TH-11 if it is not part of your system.
The CLINITEK Novus Automated Urine Chemistry Analyzer is a fully automated

analyzer that combines proven dry-pad urine chemistry technology with an easy-to-use
cassette test format to ensure standardized test results and maximum productivity in
busy laboratories.
The CLINITEK Novus 10 urinalysis cassette, used with the analyzer, contains test cards
on which are mounted single-use dry reagent pads for measuring bilirubin, blood
(occult), glucose, ketone (acetoacetic acid), leukocytes, nitrite, pH, protein, and
urobilinogen. An additional pad containing no reagents is used for measuring color.
During analysis, an aliquot of sample is dispensed onto the individual test pads and
concentration of each analyte is determined by intensity of color that subsequently
develops on each pad. Light reflected from the reagent pads is captured a specified time
after addition of sample using a color digital camera. The image of the test pads is then
analyzed, and the color and intensity data from each pad are converted into clinically
meaningful results.
Specific gravity and clarity of each urine specimen are also determined on the analyzer,
by measuring the transmission and scattering of light that passes through the
specimens.

Test Name Chemical Principle
Bilirubin The coupling of bilirubin with diazotized dichloroanitine in a

strong acid medium.
Blood Peroxidase-like activity of hemoglobin, which catalyzes the

reaction of diisopropylbenzene dihydroperoxide and 3,3’,5,5’-
tetramethylbenzidine.
Glucose Double sequential enzyme reaction. Glucose oxidase

catalyzes the formation of gluconic acid and hydrogen
peroxide form the oxidation of glucose. Peroxidase catalyzes
the oxidative coupling of 4-amino-antipyrine and 4-
methylcatechol by hydrogen peroxide.
Ketone The reaction of nitroprusside with acetoacetic acid.
Leukocytes Granulocytic leukocytes contain esterases that catalyze the

hydrolysis of the derivatized pyrrole amino acid ester to
liberate 3-hydroxy-5-phenyl pyrrole. This pyrrole then reacts
with a diazonium salt.
Nitrite Conversion of nitrate (derived by diet) to nitrite by the action

of Gran negative bacteria in urine.
pH Double indicator principle that gives a broad range of colors

covering the entire urinary pH range.
Protein At a constant pH, the presence of protein causes a change in

the color of the indicator.
Urobilinogen p-diethylaminobenzaldehyde in conjunction with a color

enhancer reacts with urobilinogen in a strong acid medium
(Ehrlich reaction).
Color The white pad absorbs the sample to detect urine color.

The UF-5000 is an in vitro diagnostic analyzer for the determination of formed elements
in human urine. The UF-5000 automatically mixes and aspirates human urine for the
analysis of formed elements using fluorescent flow cytometry. The UF-5000 displays
and enumerates populations of formed elements and provides flagging information for
other pathological elements.
UF-5000 PARAMETERS
Test Codes Reportable Parameters
RBC Red Blood Cells
WBC White Blood Cells
EPI Epithelial Cells
CAST Hyaline Casts
BACT Bacteria
TEST CODE FLAGGED PARAMETERS*
X’TAL Crystals
Sperm Spermatozoa
YLC Yeast Like Cells
MUCUS Mucus
PATH CAST Pathological Cast
*Flagged parameters are not directly reportable from the analyzer.

The UD-10 is an automated reflex system for the UF-5000. An image of the particles
in the sample can be captured, and the particles in the image are displayed by size.
The image results are displayed in the UD-10 LCD touch panel.
The instrument can only be used to analyze human urine and control material
samples. It cannot be used for any other purpose.
Displayed Items Particle Image Size

Class 1 2-6 µm
Class 2 6-10 µm
Class 3 10-16 µm
Class 4 16-36 µm
Class 5 36-71 µm
Class 6 71-101 µm
Class 7 101-151 µm
Class 8 151 µm or more
The Urinalysis Data Manager (UDM) is an instrument status and data management
software system specifically for Sysmex urine analyzers and imaging devices.
The UDM performs analysis order registrations and patient information management.
The UDM supports the technical validation of diagnostic results combined with rule
based judgements, as well as quality control management and the manual
classification of human urine particle images captured by the UD-10.
The software does not modify analytical data from any of the analyzers. The UDM can
transmit results to a host computer and printer for result review.

II. Specimen Requirements
A. Acceptable specimen requirements
1. Uncentrifuged urine without preservative.
2. Sampler mode
a. Novus requires a minimum of 2.0 ml of urine.
b. UF-5000 requires a minimum of 2.0 ml of urine.
c. UD-10 requires a minimum of 1.6 ml of urine
3. Manual/STAT mode
a. UF-5000 requires a minimum of 0.6 ml of urine.
b. UD-10 requires a minimum of 0.6 ml of urine.
NOTE: Novus does not have a manual/STAT mode
4. If analysis is not possible within one hour of collection, the urine may be
refrigerated. No significant interference from amorphous urates or phosphates
has been demonstrated on the UF-5000.
B. Unacceptable urine specimens including those listed below should not be

analyzed:
1. Turbid samples containing high number of WBC, RBC, bacteria, or crystals.
2. Urine that is visibly mucoid or has visible large particles.
3. Urine containing visible foam.
C. Specimen Stability
1. Urine analysis should be performed as soon as possible, preferably within 1 hour
of collection.
a. Formed elements may disintegrate at varying rates depending on pH,
osmolality, and storage conditions.
b. Chemical changes can occur if samples are left at room temperature for 2
hours or more.
2. Samples that have been exposed to sunlight can deteriorate.
3. If analysis is not possible within one hour of collection, the urine may be
refrigerated. No significant interference from amorphous urates or phosphates
has been demonstrated on the UF-5000.
Complete this section with your laboratory’s policy for sample handling when
urine specimens cannot be analyzed within one hour of collection or refrigerated.

III. Supplies and Reagents
A. Supplies
1. Deionized water.
2. Kimwipes™, gauze, or plastic lined wipes.
3. Urine sample tubes with a diameter of 12-16mm and a height of 95-120mm.
4. Urine sample cup compatible with adapter No. 368.
5. Plastic squeeze bottles.
6. 5.25% Sodium Hypochlorite
7. Tube types for TH-11
The chart below are the acceptable tube types that have been tested for the TH-11.
Manufacturer Model No. Cap Type Bottom Shape Size
Becton Dickinson 364979 Rubber Round type 16X100
364980 Rubber Cone Type 16X100
364992 Rubber Cone Type 16X100
365000 Resin Cone Type 16X100
364915 Resin Round Type 16X100
Greiner 455007 Resin Round Type 16X100
SARSTEDT 10.252 Resin Screw Flat Type 15.3X100
B. Reagents
Follow manufacturer’s instructions for the storage and expiration date for all
reagents.
Record date received and date opened on reagent container.
All reagents are azide-free and intended for in vitro diagnostic use as directed. Do
Not Ingest.
REAGENT ANALYZER(S) OPEN STABILITY

UF- CELLSHEATH™ UF-5000 UD-10 60 DAYS
UF- CELLPACK™ SF UF-5000 90 DAYS
UF- CELLPACK™ CR UF-5000 90 DAYS
UF-Fluorocell™ SF UF-5000 90 DAYS
UF-Fluorocell™ CR UF-5000 90 DAYS
CELLCLEAN™ UF-5000 UD-10 60 DAYS
CLINITEK Novus 10 Siemens CLINITEK Novus 14 days
Urinalysis Cassette
CLINITEK Novus Rinse Siemens CLINITEK Novus
Additive 2 weeks after dilution with
distilled water
1. UF-CELLSHEATH™

UF-CELLSHEATH is the dedicated sheath fluid used on the UF-5000 and UD-10. This reagent
is intended for use only in conjunction with the other reagents in use in this instrument, and is
used to count formed elements by the flow cytometry method.
UF-CELLSHEATH Active ingredients

Tris Buffer 0.14%
UF-CELLSHEATH Storage
a. Store UF Sheath at 2-35oC, out of direct sunlight and dust.
b. Do not freeze.
c. Use care to avoid creating bubbles in the reagent before use. Air bubbles
may cause incorrect analysis.
d. UF-CELLSHEATH which shows signs of contamination such as turbidity or
discoloration should not be used.
UF-CELLSHEATH Stability
a. Unopened UF-CELLSHEATH is stable until expiration date shown on the
container.
b. Opened UF-CELLSHEATH is stable for 60 days.
UF-CELLSHEATH disposal procedures

a. If disposing of fluid, make sure that any remaining fluid has been removed
from the container before disposing.
b. Disposal procedures for the used container, remaining fluid, and waste fluid
including samples, should meet requirements of applicable local regulations.
CAUTION: For in vitro diagnostic use only. Do no ingest. Avoid skin and eye
contact. In case of contact, flush with plenty of water immediately. Consult
with physician in case of ingestion or eye contact. During use, store in an
environmentally clean area.
2. UF-CELLPACK SF
UF-CELLPACK SF is intended for use only in conjunction with UF-Fluorocell SF,
and is used to mark formed elements in urine for the determination of materials
lacking a nucleus (RBCs, casts, etc.). When UF-CELLPACK SF is used as a
diluent, the diluted samples must be analyzed within 30 minutes.
UF-CELLPACK SF Active ingredients

Hepes 1.2%
1,2-Benzisothiazolin-3-one <0.01%
UF-CELLPACK SF Storage
a. Store UF-CELLPACK SF at 2-35oC, away from direct sunlight and dust.
b. Do not freeze.
c. Handle the reagent with care to prevent air bubbles. If air bubbles present,
the performed analysis may be incorrect.
d. Do not use the reagent which shows signs of contamination or instability,
such as turbidity or discoloration.
UF-CELLPACK SF Stability
a. Unopened UF-CELLPACK SF is stable until the expiration date shown on the
container.
b. Opened, UF-CELLPACK SF is stable for 90 days.
UF-CELLPACK SF disposal procedures

including samples should meet requirements of applicable local regulations.
CAUTION: For in vitro diagnostic use only. Do not ingest. Avoid skin
and eye contact. In case of contact, flush with plenty of water
immediately. Consult with physician in case of ingestion or eye contact.
During use, store in an environmentally clean area.
EUH208 Contains 1.2-benzisothiazolin-3-one. May produce an allergic
reaction
EUH210 Safety data sheet available on request
Components: 1,2-Benzisothiazolin-3-one, <0.01%
3. UF-CELLPACK CR
UF-CELLPACK CR is intended for use only in conjunction with UF-Fluorocell CR,
and is used to mark formed elements in urine for determination of materials
containing a nucleus (WBCs, epithelial cells, bacteria etc.).
UF-CELLPACK CR Active Ingredients

Acetic Acid <0.1%
UF-CELLPACK CR Storage
a. Store UF-CELLPACK at 2-35oC, away from direct sunlight and dust.
b. Do not freeze.
c. Handle the reagent with care to prevent air bubbles. If air bubbles are
present, the performed analysis may be incorrect.
d. Do not use the reagent which shows signs of contamination or instability,
such as turbidity or discoloration.
UF-CELLPACK CR Stability.
a. Unopened UF-CELLPACK CR is stable until the expiration date shown on the
container.
b. Opened, UF-CELLPACK CR is stable for 90 days.
UF-CELLPACK CR disposal procedures

including samples, should meet requirements of applicable for local
regulations.
CAUTION: For in vitro diagnostic use only. Do not ingest. Avoid skin
and eye contact. Consult physician immediately in case of ingestion or
eye contact. In case of contact, flush with plenty of water immediately.
When handling the stain, operators must wear protective gloves so that
the solution does not come into contact with skin. If the solution comes
into contact with the skin, wash immediately with an adequate volume of
running water. During use, store in an environmentally clean area.
4. UF-Fluorocell SF
UF-Fluorocell SF is used to mark formed elements in urine for determination of
materials lacking a nucleus (red blood cells, casts, etc.). The reagent is used in
conjunction with UF-CELLPACK SF.
UF-Fluorocell SF Active Ingredients

Polymethine dye 0.05%
Ethylene glycol 99.9%
UF-Fluorocell SF Storage
a. Store UF-Fluorocell SF at 2-35oC, away from direct sunlight and dust.
b. Do not freeze.
d. Product information is managed by the IC tag (RFID) on the label of the
reagent. Do not remove the IC tag until disposal. If the tag is removed, the
reagent information will not be recognized.
UF-Fluorocell SF Stability
a. Unopened, UF-Fluorocell SF is stable until the expiration date shown on the
container.
b. Opened, UF-Fluorocell SF is stable for 90 days.
UF-Fluorocell SF Disposal Procedures

a. Dispose of the cartridge after removing residual reagent solution and tightly
seal the spout of the cartridge before disposing to prevent residual reagent
solution leakage. You may use tape to secure the spout.
including samples should meet requirements of applicable local regulations.
CAUTION: For in vitro diagnostic use only. Do not ingest. Avoid skin and
eye contact. Consult physician immediately in case of ingestions or eye
contact. In case of contact, flush with plenty of water immediately. When
handling the stain, operators must wear protective gloves so that the
solution does not come into contact with skin. If the solution comes into
contact with the skin, wash immediately with an adequate volume of
running water. During use, store in an environmentally clean area.
5. UF-Fluorocell CR
UF-Fluorocell CR is used to mark formed elements in urine for the determination
of materials containing a nucleus (WBCs, epithelial cells, and bacteria, etc.). The
reagent is used in conjunction with UF-CELLPACK CR.
UF-Fluorocell CR Active Ingredients

Polymethine dye 0.02%
Ethylene glycol 99.9%
UF-Fluorocell CR Storage
a. Store UF-Fluorocell CR at 2-35oC, away from direct sunlight and dust.
b. Do not freeze.
d. Product information is managed by the IC tag (RFID) on the label of the
reagent. Do not remove the IC tag until disposal. If the tag is removed, the
reagent information will not be recognized.
UF-Fluorocell CR Stability
a. Unopened, UF-Fluorocell CR is stable until the expiration date shown on the
container.
b. Opened, UF-Fluorocell CR is stable for 90 days.
UF-Fluorocell CR Disposal Procedures

a. Dispose of the cartridge after removing the residual reagent solution and
tightly seal the spout of the cartridge before disposing to prevent residual
reagent solution leakage. You may use tape to secure the spout.
including samples should meet requirements of applicable local regulations
and Blood borne Pathogen Standards.
CAUTION: for in vitro diagnostic use only. Do not ingest. Avoid skin
and eye contact. Consult physician immediately in case of ingestion
or eye contact. In case of contact, flush with plenty of water
immediately. When handling the stain, operators must wear
protective gloves so that the solution does not come into contact with
skin. If the solution comes into contact with the skin, wash
immediately with an adequate volume of running water. During use,
store in an environmentally clear area.
6. CELLCLEAN
CELLCLEAN is a strong alkaline detergent which must be used in the rinse
solution to clean the fluid system components of the UF-5000 and
UD-10
CELLCLEAN Storage and Shelf Life
a. CELLCLEAN has an opened stability of 60 days
b. CELLCLEAN must be stored in a dark place. Avoid exposing to direct
sunlight, or the effectiveness of this detergent will be lost depending upon the
time period of exposure.
CELLCLEAN disposal procedures
CELLCLEAN disposal procedures should meet requirements of applicable local
regulations.
CAUTION:
 This reagent is strongly alkaline. Exercise caution when handling.
 Always
Document Number: 1519-LSS, wear
Rev 3. July appropriate PPE equipment when handling the
2021 reagent.
Page 13 of 65
 Never use this reagent on human body.
Classified as Internal  Avoided contact with skin and eyes, and avoid ingestion.
 In case of skin contact, rinse immediately with plenty of water.
8. CLINITEK Novus 10 Urinalysis Cassette
CLINITEK Novus 10 Urinalysis Cassettes is intended for the measurement of
albumin, bilirubin, blood (occult), glucose, ketone, leukocytes, nitrite, pH, protein,
and urobilinogen. It is designed to be used only with the CLINITEK Novus
Automated Urine Chemistry Analyzer.
Cassette storage and handling

a. Store unopened cassettes at room temperature (15-30ºC) and ensure that
humidity does not exceed 80%.
b. On board stability is 14 days
c. If an opened cassette is not loaded onto the system within 15 minutes, the
reagent may not yield satisfactory results.
d. Protection against exposure to light, heat, and ambient moisture is mandatory
to guard against altered reactivity.
e. Do not use the cassette if the foil lid or plastic tray is damaged.
Cassette disposal procedures

a. Disposal of this product, solutions, and any by-products should at all times
comply with the requirements of environmental protection and waste disposal
legislation and any regional local authority requirements.
NOTE: This material is not considered hazardous by the OSHA Hazard

Communication Standard and is not expected to produce significant
adverse health effects when the recommended instructions for use
are followed.
9. CLINITEK Atlas Positive and Negative Controls

NOTE: if using an alternate control, edit this section
When used with the CLINITEK Novus and CLINITEK Novus 10 Urinalysis
Cassette, the Positive and Negative controls provide defined results for color,
clarity, glucose, bilirubin, ketone, specific gravity, blood, pH, protein,
urobilinogen, nitrite, and leukocytes.
Control Storage and handling

a. Store strips in the original tightly capped bottle at room temperature (15-
30ºC).
b. Protect bottle from direct sunlight.
c. Do not remove desiccant from bottle.
d. Strips are stable until the expiration date shown on the bottle label.
e. Storage requirements after strips are reconstituted in solution:
1) Negative control – Stable for 8 hours at 18-23ºC. If environment
conditions are outside of range – they may be refrigerated at 2-8ºC. to
maintain the 8 hour stability.
2) Positive control – Because bilirubin is present in the positive control,
stability is 3 hours at 18-23ºC. Protect from light.
Control disposal procedure
a. Disposal of this product, solutions, and any by-products should at all times
comply with the requirements of environmental protection and waste disposal
legislation and any regional local authority requirements.
NOTE: This material is not considered hazardous by the OSHA Hazard

Communication Standard and is not expected to produce significant
adverse health effects when the recommended instructions for use
are followed.
10. CLINITEK Novus Calibration Kit

The Calibrators are used with the CLINITEK Novus Automated Urine Chemistry
Analyzer to enable the user to obtain readings in a urine specimen for: color,
clarity, glucose, bilirubin, ketone, specific gravity, occult blood, pH, protein,
urobilinogen, nitrite, and leukocytes.
Calibrator storage and handling

a. Store the calibrators in the original, tightly capped bottles in a refrigerator at
temperatures between 2-8ºC.
b. Do not freeze.
c. Calibrators are stable until the expiration date shown on the bottle.
Caution: May cause eye and skin irritation and contains material that
can cause target organ damage. Check for and remove any contact
lenses. Immediately flush eyes with plenty of water for at least 15
minutes, occasionally lifting the upper and lower eyelids. In case if
skin contact, immediately flush skin with plenty of water for at least 15
minutes and remove contaminated clothing and shoes. Get medical
attention if necessary or if symptoms occur.
Calibrator disposal procedures

a. Sodium azide can react with copper and lead plumbing to form explosive
metal azides. On disposal, flush reagents with a large volume of water to
prevent the buildup of azides, if disposal into a drain is in compliance with
federal, state, and local requirements.

10. UF CONTROL™ Commercial Control Material
NOTE: if using an alternate control, edit this section
UF CONTROL is a bi-level commercial control for in vitro diagnostic use with the
UF-5000 and UD-10
NOTE: When using other applicable control material, the
laboratory is responsible for determining the appropriate quality
control procedures for their laboratory and for complying with
applicable laboratory regulations.
UF CONTROL Active Ingredients

UF CONTROL contains latex particles representing red blood cells, white blood
cells, epithelial cells, casts, and bacteria.
UF CONTROL L
Control Particles: 0.10%
UF CONTROL H
Control particles: 0.40%
UF CONTROL Storage
a. Store UF CONTROL at 2-8oC.
b. Do not freeze.
c. When not in use, store in box to avoid direct sunlight.
UF CONTROL Stability
a. Unopened, UF CONTROL is stable until the expiration date printed on the
box, assay sheet and control bottle label.
b. Opened, UF CONTROL is stable for 30 days.
UF CONTROL Disposal Procedure

UF CONTROL does not contain any biohazardous substances. Disposal
procedures should meet the requirements of applicable local regulations.
CAUTION: For in vitro diagnostic use only. Do not ingest. If ingested,

obtain immediate medical attention. If solution comes into contact with
the skin, wash immediately with an adequate volume of running water.
If the solution gets into the eyes, wash immediately with an adequate
volume of running water and obtain medical treatment.
C. REAGENT REPLACEMENT
Recommended: Wear PPE equipment for protection, and to prevent

contamination of the reagent on all reagent changes.
1. REPLACING DILUENT/SHEATH – UF-5000
a. If the reagent runs low during analysis or expires, the [ErrorHelp] dialog box
will appear and analysis is suspended.
b. Touch the [Reset Alarm] button and replace the reagent immediately.
c. A message displays as to what reagent is empty/expired. Touch [Reagent
Replace].
d. In the Reagent dialog box, touch the icon that indicates the reagent needing
replacement.
e. Place a check in the Reagent dialog box and be sure the cursor is displayed.
f. Using the handheld reader, scan the “Reagent Code” on the new reagent
container.
g. Touch [Register] on the Reagent Dialog box.
h. The Reagent Box will indicate ‘Received’ when the registration is complete.
i. Open the cap on the new container. When switching reagents, be sure to
avoid contamination of the tubing.
j. Remove the cap from the expired/empty container and carefully remove the
spout.
k. Insert the spout straight into the new container.
l. Tighten the cap on the new container, and move the new container into
position.
m. If multiple reagents require changing, return to step “d”.
n. Touch [Replace] to prime the new reagent. A “Replacing Reagent” dialog
box is displayed showing a replacement timeline.
o. When the process is complete, the “Reagent” box return. Touch [Close].
Reagent replacement tracking is available on the UF-5000 and UDM. Follow

laboratory SOP for Reagent Change documentation.
CAUTION:
 Do not add new reagent to existing reagent.
 Install reagent at a height no more than 1 meter above or below the
bottom of the analyzer. Do no put reagents on top of the instrument.
 Take care not to spill reagent. In case of spillage, wipe immediately
with a damp cloth, otherwise the coated surface of the instrument may
become stained or deteriorated.
 Read the indication of the reagent container or package box, Safety
Data Sheet, and General Information before handling reagents.
 Do not touch the aspiration nozzle of the float switch/dispensing set.
Keep dust dirt, bacteria, and other contaminants away from the
aspiration nozzle and the inside of the container.

†
2. REPLACING DYE CARTRIDGES ON THE UF-5000

a. If the dye runs low or expires during analysis, the [Error Help] dialog box will
appear and analysis is suspended.
b. Touch the [Reset Alarm] button and replace the reagent immediately.
c. Read the error message to determine which reagent is empty/expired and
then touch [Reagent Replace].
d. Lift up the top front cover of the analyzer.
e. Remove the old dye cartridge from its holder by lifting the handle straight up,
and discard.
f. Install the new dye cartridge into the holder, making sure the color matches.
 The analyzer will beep as the information is automatically registered by
the Radio Frequency Identification (RFID) chip.
 Close the holder door, then close the top front cover of the analyzer.
 Reagent replacement will begin automatically; when complete the reagent
registration dialog box updates.
g. Touch Close.
Reagent Replacement tracking is available on the UF-5000 and

UD-10. Follow laboratory SOP for documenting reagent changes.
CAUTION:
 If you install the incorrect reagent, an error occurs and an alarm
sounds. Check the error and install the correct reagent.
 Take care not to spill reagent. In case of spillage, wipe
immediately with a damp cloth. Otherwise, the coated surface of
the instrument could be stained or deteriorated.
3. Replacing UF-CELLSHEATH on the UD-10.

When UF-CELLSHEATH runs out or expires, an error message appears and
analysis is suspended. Replace the reagent immediately.
a. Touch the [Reagent Replacement] icon on the menu screen to display the
[Reagent] dialog box. The [Reagent] dialog box allows the user to check the
status of reagents and to replace the reagent(s).
NOTE: The reagent dialog box can also be displayed by touching the
indicator for reagent status on the control menu at the bottom of the
screen.
b. Prepare the new reagent according to package instructions.
c. Display the [Reagent] dialog box.
d. Enter the reagent code of the new reagent using the barcode reader.

NOTE: if barcode reader is not available, enter the reagent code manually
into the reagent code box. Select [Replace the reagent] box and
touch [Register], then follow instructions.
e. Remove the cap from the new reagent.
f. Remove the cap from the old reagent turning the lower part of the cap in the
direction of the arrow.
g. Pull out the float switch straight up.
h. Insert the float switch into the new reagent.
i. Touch [Replace] in the reagent dialog box. The progress dialog box
appears, and reagent replacement starts.
4. Replenish Rinse Water – UF-5000 and UD-10

a. Remove the cap from the rinse water bottle.
b. Pull the spout kit straight up.
c. Replenish the rinse water in the water bottle until it is full.
d. Insert the spout kit straight into the rinse bottle.
e. Close the cap of the rinse bottle.
f. Touch the [Reagents Replacement] icon on the [MENU] screen.
g. Touch [Rinse Water].
h. Touch [Register]. The progress dialog box appears and reagent replacement
starts.
5. Load reagent cassettes – CLINITEK Novus

a. Select [System] then [Load & Unload]
b. Select [Yes] to confirm unloading of a cassette.
c. Open the system cover.
d. Turn the lock on the cassette door counterclockwise then open the door.
e. Hold the cassette by the handle and slide it towards you to remove.
f. Prepare the new cassette:
 Use the foil tab to peel the foil seal off the tray.
 Remove the cassette from the tray.
 Pull the shipping card out of the cassette.
 Do not turn the cassette upside down, as the cards may fall out.
NOTE: Determine if the analyzer will require calibration, and plan
accordingly, prior to removing the foil seal. If calibration is
required, the seal should not be removed until calibration and
quality control material are warmed to room temperature and are
ready to process.
g. Load the new cassette onto the rails and slide it into the instrument.
h. Close the door and turn the lock clockwise to lock the door.
i. Close the system cover. The system reads the log number and expiration
date from the cassette.
6. Fill the rinse bottle – CLINITEK Novus

The system is configured with an external rinse bottle. It must be checked
visually.
a. Locate the rinse bottle at the rear of the analyzer.
b. Remove the cap and empty the remaining rinse.
c. Fill the rinse bottle with 1000 mL. distilled or deionized water.
d. Add 2 mL. of CLINITEK Novus Rinse Additive. Gently swirl to mix trying to
avoid excess bubbles.
e. Replace the cap.
f. Prime the pump.
7. Urinalysis Data Manager (UDM) reagent tracking

Information on reagent status can be viewed by touching the Reagent Levels box
on the bottom of the UDM computer screen. The UDM history log receives the
reagent information from barcoded reagents for each of the analyzers connected
to the UDM. Storage capacity for reagent replacement history is 3000 entries.
To view the reagent log:
a. From the main menu – touch [History].

b. Touch [Analyzer].
c. Touch the [Reagent] tab.
 To filter the log for a specific date range, touch
[Filter] >[Date]>[Select]. Enter the opening date and end date using the
on board touch screen.
 To filter the log for a specific user, touch [Filter]>[User]>[Select]. Enter
user logon. Touch [OK].
 To print the log, touch [Output] on the tool bar.
IV.

IV CALIBRATION
Initial calibration is performed during installation on the UF-5000 and UD-10 by the
Sysmex Service Engineer (SE). Calibration compensates for any bias inherent to the
pneumatic, hydraulic, and electrical systems that may affect the accuracy of results.
Calibrators traceable to reference methods are used in the calibration of the instrument.
Documentation of parameters that can be calibrated and reference methods for
calibrator target value assignments area contained in the calibrator package inserts (if
applicable).
Calibration by a Sysmex Service Engineer is also required if one or more of the following
occur:
 Critical dilution components, analytical parts, and assemblies are replaced.
 Controls/calibrators are outside of acceptable limits and cannot be corrected by
maintenance or troubleshooting.
 When advised by a Sysmex Representative.
Calibration should only be completed when troubleshooting indicates that there is no
major underlying problem with the analyzer, reagents, or quality control materials.
Bi-Annual calibration verification (if required) may be performed by review and

documentation of commercial quality control (QC) results, proficiency testing results, or
patient control testing results. Calibration verification may also be accomplished by
processing a commercial calibrator and comparing results to those published on the
calibrator assay sheet.
UF-5000 bi-annual calibration verification

The most common processes for Precision and Calibration of the Sysmex analyzer is
the utilization of Sysmex sponsored calibration/precision events defined by the analyzer
service contract. Calibration verification procedures may be done by a Sysmex Service
Engineer on site or remotely through the Sysmex Network Communications System
(SNCS™) with the Sysmex Calibration Specialist. The following items are completed by
the Sysmex representative during the calibration verification process.
 Documentation and review of analyzer service history.
 Documentation and review of QC testing results.
 Documentation and review of historical Sysmex QC reports.
 Analyzing the Sysmex calibrator according to the manufacturer’s recommendations
to verify precision and calibration (accuracy) of the analyzer.
 Documentation of calibration verification results and generation of a calibration
verification certificate for laboratory records.
UD-10 calibration
Unless UD-10 control values are outside of manufacturer’s stated ranges, Bi-annual
calibration verification or remote calibration on the UD-10 will not be performed based on
the manufacturer’s recommendations.

A. CLINITEK Novus Calibration
1. Calibration Frequency
a. When analyzer is initially installed.
b. When you load another cassette with the same lot but did not calibrate the
system within the last 24 hours. The status bar displays Not Ready.
c. When you load a new cassette lot. The status bar display Not Ready.
d. The system displays error messages requiring you to calibrate the system.
The status bar displays Not Ready.
e. When you enable the Report Clarity setting and the last calibration did not
include clarity reporting.
f. When you upgrade the software.
g. When you replace the pipette, SG sensor, or syringe.
2. Calibration Preparation
Important: Before calibrating, be sure the SG well has hydrated for at least one
hour if the instrument is newly installed or if the power has been off for longer
than one hour.
a. Pour at least 2 mL of a 5.25% sodium hypochlorite into a properly labeled
sample tube. You can reuse this tube throughout the day as needed without
discarding it. However, the tube must always contain at least 2 mL.
b. Pour at least 3 mL of each calibration solution (from the Calibration Kit) into
the properly labeled sample tubes (1 tube per solution) for CAL #1, #2, #3,
and optionally, CAL #4.
NOTE: if you disable the Report Clarity setting, you do not need to use CAL #4 for
calibration. Refer to Section 7 – System Configuration, in the CLINITEK Novus
Automated Urine Chemistry Analyzer Operator’s Guide for additional information on
the Report Clarity Setting
c. Allow all of the solutions to equilibrate to room temperature before you use
them.
3. Calibration Procedure
a. Press the start/stop switch on the conveyor. The LED status display will
illuminate yellow.
b. Place the rack with the calibrator tubes on the right pool of the Novus.
c. Select [System] from the Home screen.
d. Select [Calibration].
e. If necessary, enter the operator ID (initials).
f. To change or add a lot number, touch [Change], then enter the information.
Touch [Next].
g. Follow the instructions on the screen to place the tubes in the rack:
Bleach Pos 1 at least 3 mL

Cal 4 Pos 2 at least 5 mL

h. Select [Start] and the screen will count down from 3:13 to zero.
i. The analyzer updates the progress of the run.
j. Select [Exit] to return to the system menu.
k. If calibration passes, the status bar will return to “Ready” and the system will
be ready to process quality control and patient samples.
V. QUALITY CONTROL
Quality Control is performed in order to monitor an analyzer’s performance over time.
Quality control should be run in accordance to licensing agency regulations. It should be
noted that for troubleshooting purposes, additional control runs may be necessary.
The Sysmex Beyond CareSM Quality Monitor for Urinalysis (BCQMu) will provide a
simplified and consolidated platform for quality control monitoring for the UF-5000 and
UD-10. The function of BCQMu is to manage and interpret incoming quality control runs,
while providing real time feedback on analyzer performance. There is no data entry into
BCQMu The information for the Lot Numbers and expiration of control types, the upper
and lower limits and target values, and the results from QC performed on all analyzers
are received by SNCS from the analyzers.
A. Frequency of Quality Control Analysis and Review

Complete this section with your laboratory’s policy for quality control analysis
and review frequency.
Note: If using another control – enter information here.
UF CONTROL H will be run at ________AM/PM
UF CONTROL L will be run at________AM/PM
Siemens CLINITEK Atlas Positive and Negative controls __________AM/PM
Supervisor or designate will review quality control every________
B. Preparation of QC files – CLINITEK Novus

The procedure is written for the use of the CLINITEK Atlas Positive and Negative
Controls using only 2 levels. If another control type is to be used on the Novus, it
must first be configured in the Novus configuration menu. For additional information,
refer to CLINITEK Novus Automated Urine Chemistry Analyzer Operator’s Guide –
Configuring the Control Samples.
1. Make sure the Novus and the Urinalysis Data Manager (UDM) are configured to
report the correct units. There are 4 options:
 Conventional
 Conventional with Plus System
 SI
 Si with Plus System
a) To make changes to the system, from the Home screen, select [Set-up >
Configuration > Operations > Set-up Assistant].
b) Select the Radio button for the units that your laboratory will be reporting.
c) Keep clicking the right arrow on the bottom of the screen until you have
the necessary changes. The last screen will allow you to save your
changes.
Changes to the UDM for control unit type must be made by Sysmex.
Please contact Sysmex for assistance.
2. Select [System > Control]
3. Select the [Change] button that corresponds with the control you wish to change
or add.
4. Select [Add].
5. Enter the control lot #, select [Enter].
6. Enter the control lot expiration date, select [Enter].
7. Repeat for additional control.
NOTE: Before processing QC samples on the Novus, controls must first be

programmed on the UDM in order for the results to be received. See procedure
“QC new lot registration on the UDM” in this section
C. Analysis of Quality Control Material – CLINITEK Novus
IMPORTANT: If you analyze three control samples consecutively (with no other urine
samples in between the samples in the rack for control testing), clean the SG well
immediately after you test the third control and before you test any patient samples or
additional controls.
1. Prepare Controls (Add your laboratory specific procedure for preparing controls
according to Manufacturer’s Instructions).
2. Place up to three tubes of control solution into a rack in the following positions:
 Control 1: Position 1
Note: Do not use tubes that are flared when running > 2 controls. The tube
type must be straight so that 3 tubes can be placed in the rack consecutively.
3. Depress the stop/start button on the CV-11. The status indicator light will
illuminate orange.
Place the rack in the loading area on the right side of the analyzer, with the open
side of each tube slot in the rack facing the system.
CAUTION! Do not place the tubes with control solutions in incorrect rack positions. If you
do, the system processes those samples anyway and the control results will be incorrect.
4. Select [System > Control]. Verify control lots are correct.

 To change or add lots, follow instructions for Preparation of QC Files in this
document.
5. Select [Next]. The rack moves into position for testing and the system tests each
control once.
6. After the system moves the rack to the left side of the analyzer, remove the rack.

D. Preparation of QC files – UF-5000
Before analyzing controls, verify UF-5000 QC settings, and input the lot numbers and
expiration dates in the QC files to be used.
1. From the Main Menu, touch [Settings].
2. Touch [QC].
3. Touch [QC METHOD] and select the radio button for L-J. Touch [Register].
4. Touch [Limit], and select the radio button for Value (#). Touch [Register].
5. Return to Main Menu. Touch [Menu] and select [QC].
6. Select either UF CONTROL L or UF CONTROL H tabs for the desired QC.
7. Select [Register] from the top tool bar.
a. If there are 3 lots already scheduled, a prompt will appear to delete the least
current lot before you can proceed.
8. QC Lot information may be entered by one of the following methods.
Handheld Barcode Reader
a. With the handheld barcode reader, scan the QC barcode for each parameter
on the UF CONTROL assay sheet.
 When the barcode has been successfully read, the handheld barcode
reader will beep.
b. When complete touch [Register].
Note: If the [Register] icon is not available, one or more of the parameters
failed to scan. Review the parameters and scan again.
 Expiration date will default to open vial stability (30 days) or Lot
expiration, whichever is earlier.
Manual entry
a. Access the touch screen keyboard by touching the Lot Number, which has a
prefix of [QC-].
b. Manually enter the lot# and expiration date of control type.
c. Touch each parameter by using the on screen keyboard and manually enter
each target/limit provided on the control/assay sheet.
d. Touch [Register] when all items are registered.
NOTE: When connected to the UDM, newly created QC files and results
for the UF-5000 will automatically transfer to the UDM.
E. Analysis of Quality Control Material – UF-5000

Allow control material to come to room temperature (15-30oC) for 20-30 minutes
before use.
UF CONTROL is intended for use exclusively with Sysmex specific reagents. If

other reagents are used, the product performance of Sysmex Instruments
cannot be guaranteed.
1. From the main menu, touch [QC].

2. Select the Lot# from the radio button on the bottom of the screen.
3. Follow manufacturers’ instruction for preparing and mixing UF CONTROL.
4. Immediately dispense 0.6ml. (13-18 drops) of UF CONTROL into a new sample
cup. Place the sample cup into adapter #368.
5. Within 10 seconds after dispensing, touch [Analysis] > [Yes].
6. Touch UF CONTROL L or UF CONTROL H and touch [Next].
 If open bottle stability of the bottle has expired, touch [CHANGE BOTTLE] to
switch the control to a new bottle.
7. Push the STAT sample tube holder in and touch [ANALYSIS START]. This will
initiate sampling.
8. After QC analysis is complete, results will display in the dialog box. Use left ◄ or
right ► arrows to view QC results.
 If results are outside expected ranges, or if the control material has expired,
the analyzer will alert the operator with a warning and audible sound. Touch
L-J Limit Control. A pop-up box appears. Touch [ERR Recovery] to
acknowledge error and exit.
9. Touch [Exit] to accept control if acceptable. Touch [Repeat] to discard results
and reanalyze using a freshly prepared sample.
10. Press the STAT button on the analyzer to retrieve the sample cup.
11. To continue QC analysis, return to step 6.
12. Exit the QC analysis program by touching [Close].
F. Preparation for QC Files for the UD-10

New control lot registration can be uploaded by reading the barcodes on the assay
sheet with the barcode reader.
1. Touch the [QC] icon ono the [Menu] screen.
2. Touch the tab of the control that you want to enter lot information.
3. Touch the [Register] button on the tool bar. The [Register lot Information] dialog
box appears.
NOTE: When 3 lots are already registered for the controls a dialog
box appears with the existing lots on board. Select the lot number
you want to delete and select [New Regist].
4. With the barcode reader in hand, scan the barcode on the assay sheet provided
with the new control. The barcode reader will beep when the barcode is
successfully read.
5. Enter the package expiration date. Opened expiration date will be automatically
recorded.
6. Touch [Register].
NOTE: WBC on the UF-CONTROL assay sheet is equivalent to Class 2
on the instrument.

NOTE: When connected to the UDM, newly created QC files and
results for the UD-10 will automatically transfer to the UDM.
G. QC Analysis on the UD-10

1. Touch the [QC] icon on the menu screen.
2. Touch the [Analysis] button on the tool bar. A QC dialog box appears.
3. Touch [Yes].
4. Select the appropriate QC file tab: L for Low and H for High.
 To switch the control to a new bottle, touch [Change bottle] > [Yes] in the
dialog box that appears.
5. Select the lot number, then touch [Next]. The “QC Analysis” dialog box
Appears and the STAT sample tube holder lock is released.
6. Mix the control according to the package insert.
7. Transfer 0.6mL of the control to the sample cup.
8. Set the sample in the black adapter No. 368.
9. Set the control into the STAT sample holder.
10. Push in the STAT sample tube holder until it locks.
11. Touch [Analysis Start] to start QC analysis.
 This button becomes available once the STAT sample tube holder is correctly
locked into place.
 Once aspiration of the control is completed, the STAT sample tube holder
lock is automatically released.
 Progress of the QC analysis is shown in a progress bar on the bottom of the
dialog box. Wait until this is completed.
12. Press [Exit] to accept or [Repeat] to reanalyze.
13. Press the release button on the sampler section. The STAT sampler tube holder
slides out.
14. Remove the control from the STAT sampler holder.
15. Return to step 5 to run additional QC.
16. Push in the STAT sampler tube holder. Be sure to push it until the STAT
sampler tube holder is locked.
17. Check the analysis results.
18. Touch [Close].
H. QC New Lot Registration Entry on the UDM
QC lot entry for the CLINITEK Novus is REQUIRED. It is NOT required for the UF-5000 and
UD-10.
1. Click the [QC] Icon on the Main Menu Screen.
2. Select the analyzer from the drop down menu.
3. Select an open file number and select [Register] on the tool bar. The lot
information dialog box appears.
4. Enter the Material from the drop down menu.
5. Enter the QC lot #.

6. Enter the expiration date of the control material.
a. For UF-5000 and UD-10, highlight the first QC run plotted and touch [vial line]
on the top tool bar. This will alert the user that the QC material has expired the 30
day open expiration date.
7. Enter the upper and lower target values from the package insert.
8. For Novus analyzers ONLY.
a. Designate “Control 1” material as the negative control. Place a checkmark in
the “Analysis registration lot” on the bottom of the target limit set screen. This
will always designate tube one as the negative control.
b. Designate “Control 2” material as the positive control. Place a checkmark in
the “Analysis result registration lot” on the bottom of the target limit set up
screen. This will always designate tube two as the positive control.
9. Select [OK] to save the entry.
10. Repeat the process with subsequent controls.
Note: If a QC analysis result without analyzer lot information is

received in the UDM from an analyzer, a confirmation dialog box
appears after the QC is processed on the analyzers.
Acknowledge the confirmation box to receive the QC results.
I. Recording/Storage of Quality Control Data

Follow laboratory protocol for troubleshooting Quality Control results
exceeding the upper or lower limit of acceptability. Complete this section with
your laboratory’s QC action plan for out of range commercial control products,
and documentation and retention of Quality Control Data.
1. Siemens CLINITEK Novus

a. At the home screen, click on [Results].
b. Select [Control].
c. Select the search option that best suits your search criteria.
1) Date Range – enter desired date range.
2) Control lot – enter Control lot# you wish to view.
3) Cassette lot – enter the cassette lot #.
4) All results – the results from all QC runs will be available.
5) Sequence – enter the sequence range.
d. After the search criteria is entered, a list of controls will be available.
e. Highlight the control and select [View].

f. If a flag was generated during testing, a symbol denoting the flag is displayed
adjacent to the result:
Symbol Meaning
^ Range Adjusted
‡ Sieve
* Out of expected range
† Sample Quality
g. If any results are not within the expected range, do not test patient
specimens. Troubleshoot and rerun the controls. Test and report patient
specimens only when control results are acceptable.
2. UF-5000 and UD-10 Quality Control Results Review Management

a. Radar Charts
1) From the QC Chart Screen on the desired analyzer, select control level
and lot#.
2) Touch [Radar] from the top tool bar.
NOTE: the Radar view shows only the last accepted QC run for the
control and lot# selected.
3) Results are displayed on the Radar Chart in BLUE. Parameters outside
of acceptable limits are displayed with a BLUE X with the name of the
parameter backlit in red.
4) Return back to the QC Chart (L-J Chart) by touching [QC Chart] on the
top tool bar.
b. L-J Charts
1) Touch the [QC] icon on the Menu screen on the desired analyzer to
display the QC Chart screen (L-J Charts).
2) Touch Lot Selection buttons to display the lot# desired
 The red line on the L-J display indicates the last analysis; the analysis
date is posted on the top of the chart.
 Results outside of control limits are notated with a Blue X.
 Scroll to view additional QC parameters by using the up and down
arrows to the right of the L-J graphs.
c. Selecting a range of results
1) Touch the [QC] icon on the MENU screen.
2) Select the control type and lot# desired.
3) Touch the plotted point that will be the starting point of the selection
range.
4) Touch the range selection mode button.

 Cursor moves and the range between the sub-cursor and cursor are
selected.
 Mean, SD, and CV will display to the right of each parameter.
d. Delete analysis results
1) Touch the [QC] icon on the MENU screen.
2) Select control type and lot# desired.
3) Move cursor to desired analysis results, or select a range or results.
4) To delete, touch [DELETE] on the top tool bar.
5) Touch [Yes].
e. Managing QC results using Cursor Data Settings
1) Touch [QC] icon on the MENU screen.
2) Select control type and lot# desired.
3) Touch [Chart Control] and touch [Cursor Data Management]. The
Cursor Data Management dialog box appears.
4) Select [Manage] to include results into the QC statistical values.
5) Select [Not Manage] to exclude results from the QC statistical values.
6) Input comment from the list in the drop down box or free text comment
into the “any comment box”.
3. UDM Quality Control Results Review Management
a. Radar Charts
1) Click the [QC] icon on the Main Menu Screen.
2) Select the analyzer from the drop down box in the analyzer selection
area.
3) Select the QC file you want to check.
4) To view charts, click on the Display selection button to the right of the
files.
5) The radar chart displays the latest QC analysis result of the QC files
selected from the file list.
6) If a parameter exceeds the limit value:
 The parameter name is displayed in white characters on a red
background.
 The point is displayed as a Red X.
b. QC (L-J) Charts
NOTE: Each Quality Control file menu holds 50 files. Each file can display
300 plotted points.
1) Click the [QC] icon on the Main Menu Screen.
2) Select the analyzer from the drop down box in the analyzer selection
area.
3) Select the QC file you want to review.
4) The cursor line will be on the most recent QC analysis. The date and
time stamp will be attached on the top of the QC chart display area.

Move the cursor line by using the up and down arrows to the right of the
QC chart display screen. To move the cursor line to a different analysis,
use the bottom left and right arrows on the bottom of the QC chart display
screen.
5) Plotted points are displayed as follows:
 O – (Open circle) – results are NOT managed.
 - (Solid circle) – QC analysis within range.
 X – QC analysis outside the limit range.
6) Data Information displays the value of the QC analysis result selected
with the cursor. Values outside range of limit are displayed in white
characters with a red background. Values that exceed the limit are
displayed with an [+] or [-].
 Mean displays the average value calculated from all managed QC
analysis results.
 SD displays the standard deviation calculated from all managed QC
analysis results when more than point is ranged.
 CV displays the coefficient of variation calculated from all managed
QC analysis when more than one point is ranged.
c. Selecting a range of analysis
1) While in the QC chart of the selected analyzer, click the plotted point that
will be the start point for the range selection area.
2) Click the [Range] button on the toolbar.
3) Click the end point of the range you want to select on the QC chart. The
results between the two reference lines are selected.
4) To cancel range selection, click [Range].
d. Deleting analysis results
1) In the QC Chart screen, select the analysis result, or range of analysis
results that you wish to delete.
2) Click the [Delete] button on the toolbar.
3) Click [OK].
e. Output results
1) In the QC Chart screen, select the analysis results, or range of analysis
results that you wish to delete.
2) Select the output button on the toolbar, and click the output destination.
 Host Output to host computer.
 Graphic printing to print L-J charts.
 List Printing to print QC in list format.
f. Comparing QC charts
1) In the QC Chart screen, click the [Superposition] button on the toolbar.
2) On the submenu, click [QC file is comparison].
3) Select the QC file that you want to superimpose.
4) Click [OK].
5) Up to 3 files can be displayed. To include another follow the same
procedure.
g. Comparing QC charts between analyzers
1) In the QC chart screen, click the [Superposition] button on the toolbar.
2) Select [Analyzers are compared] in the submenu.
3) In the analyzer selection area, select the analyzer whose QC chart you
want to superimpose.
4) Click [OK].
h. Saving and restoring QC file data in CSV format
1) In the QC file menu, click the QC file you want to save.
2) Select the [Output] button on the toolbar and click [CSV output].
3) Specify or create a folder.
4) Enter a file name and click [Save]. The file extension is “.csv”.
5) To restore a file, select a QC file that does not have a lot registered.
6) Select the [File] button on the toolbar, and click [Restore].
7) Search for the QC folder that file was stored in and select the QC file.
8) Click [Open].
NOTE: you cannot restore a QC file that has the same lot number
currently on board.
4. BCQMu Quality Control Review Management
The BCQMu operating system is connected to a Kuando Light which is a
notification system that alerts the user on the status of the system. The user
does not have to be logged into the application to see the status of the system.
There are 3 color status indicators which the user can view for analyzer QC
status.
 Green
o QC has been performed and passed according to range limit
specifications.
 Yellow
o QC is overdue by 50% according to the time specifications that were set
by the laboratory.
 Red
o QC is overdue by 100% according to the time specifications that were set
by the laboratory.
o QC has been performed but failed on one or more analyzers according to
range limit specifications.
a. Open the BCQMu application on the UDM

1) Logon with the users email address and password assigned.
2) The site will display, click [continue]. If there is more than one site, click
the drop down box to display additional sites. Click on the site to be
reviewed, then click [continue].

3) An avatar for the specific UN system will appear. If there is more than
one UN system, there will be more than one avatar.
4) The avatar will display in green, yellow, or red to alert the user
immediately of the status of the analyzers.
5) Click [view] under the avatar. A side bar will display with the analyzer
type and serial #. Click on an analyzer to display shift activity.
6) The shift activity will display a graph of the current lot # which includes the
shift(s), dates, and times.
7) Colored icons display on the shift activity graphs giving the user
information on the current and previous QC status of the analyzer.
8) To view each icon:
 Hover over the icon with the mouse, or use the mini map below the
table.
 A pop-up box displays with Level of control, date and time of run, and
status of Control run.
9) From the shift activity display, the user can filter the days displayed for
that lot.
10) Click on the expand button > to the left of QC Intervals
 The shift activity will expand and show the current date by default.
 Type in a date range to expand more than one day.
 Hover over the icons to review QC status.
11) A legend table for the colored icons displays on the shift activity table.
 Green
o QC has been performed and passed according to range limit
specifications.
 Yellow
o QC is overdue by 50% according to the time specifications that
were set by the laboratory.
 Red
o QC is overdue by 100% according to the time specifications that
were set by the laboratory.
o QC has been performed but failed according to range limit
specifications.
 Additionally, the icons give the status of the level of QC and
the shift
o P1 – Passed/shift 1
o P2 – Passed/shift 2
o F1 – Failed / shift 1
o F2 – Failed/shift 2
 Grey square
o Unmanaged point – Previous QC failure that user removed
from the QC statistics.
12) Click on the expand button again to return to the previous screen.

b. Viewing LJ Charts
1) From the shift activity screen, Click on [LJ Chart].
2) To display the QC in LJ format:
 Click on [calendar] and enter a date range.
 Click on [Lot Number] and select the lot to be viewed.
 Click on [Control] to view a specific level.
 Click [apply].
3) The LJ chart header displays the Item (parameter), upper limit, target,
and lower limit, Standard Deviation, Mean, CV and number of QC plots.
4) Data points within range are displayed as solid circles, data points that
are outside the UL or LL are displayed as a red X, and data points that
are excluded are displayed as hollow circles.
5) The data points will be displayed from latest to oldest, with latest to the
left of the timeline.
6) A vertical dotted line on the chart will display when there is an updated
assay sheet.
7) Hover over a point with the mouse to display the date and time of QC run,
and the value of the QC for each parameter.
8) To manage a point on the LJ Chart:
 Click on the data point.
 The Unmanage button will appear on the Filter Bar to the left of the
QC/LJ toggle.
9) Click [unmanage] and add a comment.
 Click [save].
10) The values for the entire QC run will be excluded from the Statistics.
11) Click [save].
12) The managed data points will now be a hollow circle. If you click on the
data points again – Manage will appear on the filter bar.
13) Click [manage] to include the data points in the Statistics.
14) To print or export the LJ chart:
 Click [print] on the header bar of the LJ report.
 Click [graph icon] to the left of the print icon to export CSV.
c. Reports
1) Click [Reports] on the tool bar.
2) Select type of report using a drop down box.
3) User can filter each report for date range, analyzer(s), exceptions,
parameters, Lot number and control type.
 Data Report - contains managed and unmanaged QC results with
their respective chosen parameters. Each parameter row will include
the Unit, Mean, Std Dev, CV, and QC data values. Report is in CSV
format.

 Exceptions Report – includes all failed QC results and Unmanaged
QC (with or without comments). This report is a PDF.
 LJ Chart report - includes all QC points in LJ format for analyzer and
QC lot selected in the specified date range. Date and time of each
plot displayed on the bottom of the report. This report is a PDF>.
 Parameter Report – includes all the chosen parameters and shows in
which Lot Number the parameters appear in. This report is a PDF.
 Shift Activity Report – includes the status of each control level for one
analyzer by shift, date, and time. This report is a PDF.
VI. Operating Procedure

A. START UP PROCEDURE
UDM
1. Power on the UDM computer.
2. Logon to the IPU.
a. Type in user name. Touch [OK].
b. Type in password. Touch [OK}.
Siemens CLINITEK Novus

NOTE: The Novus should never be powered off as the SG well continually needs to be
hydrated. If analyzer has been turned off, turn it back on and allow the SG well to hydrate
and stabilize for 1 hour.
1. If the System displays “Not Ready”, review the messages in the status Log.
Complete the necessary troubleshooting to bring the system to “Ready” Status.
2. Check the status of the reagent cards. If necessary, load a new reagent
cassette.
3. Check the external supply of rinse.
4. Check the card waste container and the liquid waste container. Empty if
necessary.
5. Clear any racks that may be present in pool areas.
6. Press the CV-11 power switch.
a. The conveyor will turn on. The green status light will illuminate when ready.
UF-5000
1. Check physical status of the analyzer and conveyor unit.
a. Clear racks that may be present on the left or right pool areas.
b. Verify waste tank is empty (if applicable).
c. Check if there is sufficient rinse water.
2. Press the CV-11 power switch

a. The conveyor will turn on. The green status light will illuminate when ready.

b. The UF-5000 will begin start-up and perform a self-check.
NOTE: If an error occurs during start-up, the operator

must log onto the instrument to resolve the error.
c. When the logon dialog box appears, touch the name of the user to be logged
on.
d. Enter password and touch [OK].
e. Verify background check
NOTE: Analysis is performed for background check without

sample aspiration to check the effectiveness of rinsing. This is
repeated up to 3 times. If background check fails after three
analyses, a background check error occurs.
f. All parameter values outside of acceptable ranges are displayed with a red
background on the UF-5000.
Acceptable Background checks on the UF-5000
Parameter Acceptable Limit

RBC 1.0 [/μL] or less
WBC 1.0 [/μL] or less
EC 1.0 [/μL] or less
CAST 1.0 [/μL] or less
PATH Cast 1.0 [/μL] or less
Bacteria 5.0 [/μL] or less
X’Tal 1.0 [/μL] or less
YLC 1.0 [/μL] or less
Sperm 1.0 [/μL] or less
Mucus 1.0 [/μL] or less
SF_TC 3,000 counts or less
CW_TC 300 counts or less
CB_TC 3,000 counts or less
UD-10
1. Check physical status of the analyzer and conveyor unit.
a. Clear racks that may be present on the left or right pool areas.
b. Verify waste tank is empty (if applicable).
2. Turn on the computer to the IPU.
a. Logon to the IPU.
 Type in username. Touch [OK].
 Type in password. Touch [OK].
3. The UD-10 will begin start-up and perform a self-check.
NOTE: Analysis is performed for background check without
sample aspiration to check the effectiveness of rinsing. This is
repeated up to 3 times. If background check fails after three
analyses, a background check error occurs.
UD-10 Acceptable Background Checks
Parameter Acceptable Limit

Class 1 80 or less
Class 2 15 or less
Class 3 15 or less
Class 4 10 or less
Class 5 5.0 or less
Class 6 5.0 or less
Class 7 5.0 or less
Class 8 5.0 or less
4. Press the CV-11 power switch.
a. The conveyor turns on. The green status light on the conveyor will illuminate.
TH-11
1. Press the TH-11 power switch.

a. The green status light on the conveyor will illuminate.
B. Sample Processing
BIOHAZARD
All products or objects that come in contact with human or animal body fluids
should be handled, before and after cleaning, as if capable of transmitting
infectious diseases. Wear facial protections, gloves, and protective clothing.
1. Confirm all CV-11 status indicator LED lights are illuminated and green.
2. Allow samples to reach room temperature.
3. Mix each sample thoroughly.
4. Do not test samples that are visibly bloody, mucoid, or foamy.
5. With unpreserved samples, for the most accurate results, test within two hours.
6. Prepare a well-mixed urine sample into a clean sample tube labelled with the
appropriate barcode.
a. Novus minimum sample requirements - 2.0 mL.
b. UF-5000 minimum sample requirements – 2.0 mL.
c. UD-10 minimum sample requirements – 1.6 mL.

7. Place tubes(s) in rack with barcode visible within the rack opening.
a. If using wide mouth tubes, place the tubes in every other rack position.
8. Load the rack with the groove to the right onto the right sampler pool of the first
analyzer on the automation line.
NOTE: A line may consist of analyzers in any combination, however, always in following
order below:
 TH-11 Decapper unit
 Siemens CLINITEK Novus
 UF-5000
 UD-10
a. In case of a rack jam, an alarm will sound on the CV-11. Status indicator
LED will illuminate red and rack position indicator LED will indicate the
position of the rack.
1) Press the alarm reset switch.
2) Reposition the rack.
3) Press the play button. Rack will advance.
9. If TH-11 is present, load racks onto the TH-11 rack feeder.
a. Racks enter the TH-11 decapper unit.
b. Samples are decapped.
c. Racks exit the TH-11 and progress to the UN Series Analyzers.
d. Up to 14 racks can be loaded onto the TH-11 rack feeder at one time.
10. Rack movement behavior.
b. If there is more than one identical analyzer on the line, the system will load
balance the racks and distribute to analyzers equally.
1) The first rack will proceed to the [identical] analyzer on the right; the
second rack will proceed to the [identical] analyzer on the left.
2) When analysis is complete and analyzers go into standby, the next rack
loaded will always move to the [identical] right analyzer.
c. The racks will then move onto the second type of analyzer (reflex analyzer)
and will load balance in the same fashion.
1) All tubes will be presented to the reflex analyzer(s).
2) The barcode will be read and analyzer will query for an order.
 If no order, no aspiration and the rack proceeds to next sample.
 If there is an LIS or reflex order from the UDM, the sample will be
analyzed.
d. When all required samples are analyzed, racks will eject to the left sampler
pool of the last analyzer and will remain there until the user removes them.
1) Benchtop configurations - when 8 racks have been collected, a “rack full”
error code will display with an alarm on the CV-11.
2) Wagon configurations – when 25 racks have been collected at the stock
yard, a “rack full” error will display with an alarm on the ST-10.
11. Analysis of an “urgent” sample during sample analysis.

UF-5000 and UD-10 only. Novus does not have manual mode analysis.
a. Touch [STAT] analysis button in the control menu at the bottom of the
screen. No NOT remove racks.
b. The instrument will change to STAT analysis as soon as analysis of the
current sample finishes.
c. Analyze the sample using the STAT [URI] mode.
NOTE: See “UF-5000” and “UD-10” Manual Mode Analysis using STAT
(URI) Mode in the following procedures of this document.
d. Once the sample is resulted, sampler analysis will resume.

UF-5000 Manual Mode Analysis using STAT (URI) Mode
1. Confirm the UF-5000 LED light is green and the “Sampler Ready” message is
displayed on the left side of the control toolbar, or the LED light is orange and the
“Sampler Int. Ready” message is illuminated.
2. Press the [STAT URI] icon on the bottom of the LCD screen to switch to
STAT/Manual mode. The CV-11 will be interrupted and the orange light will
illuminate.
3. A STAT Analysis dialog box appears. Touch [YES] to “Start STAT analysis of
urine sample”.
4. Enter the sample ID using the on-screen keyboard or manually scan the barcode
with the barcode reader. If performing multiple STAT samples, place a check
next to “Start STAT when the analysis finished”. This will enable tube ejection at
the end of the sample analysis.
5. Mix the urine sample and insert the uncapped tube into the sample holder, or
transfer the well-mixed urine into a sample cup.
a. If using a sample cup, set the sample cup in adapter No.368.
b. Dispense 0.6 ml. (13-18 drops) per sample cup.
6. Push in the STAT sample tube holder.
7. Touch [START] in the STAT Analysis box.
Caution: The sample tube holder is locked during STAT

analysis. Do NOT forcibly open the STAT sample tube holder or
press the release button. It may cause a malfunction of the
instrument.
8. The orange LED flashes and the “STAT Processing” message is displayed.
9. After aspiration completes, press the [Release] button to eject the sample.
a. If “Start STAT analysis of urine sample” was selected during the sample
programming, the sample will eject automatically.
b. Repeat steps 1-9 and repeat analysis.
10. Once sample analysis is complete, remove the sample. CV-11 will return to
ready.
UD-10 Manual Mode (STAT) Analysis
1. Touch the [STAT URI] analysis button in the control menu at the bottom of the
screen.
2. Touch [YES].
3. Confirm the UF-5000 LED light is green and the “Sampler Ready” message is
displayed on the left side of the control toolbar, or the LED light is orange and the
“Sampler Int. Ready” message is illuminated.

4. Press the [STAT URI] icon on the bottom of the LCD screen to switch to
STAT/Manual mode. The CV-11 will be interrupted and the orange light will
illuminate.
5. A STAT Analysis dialog box appears. Touch [YES] to “Start STAT analysis of
urine sample”.
6. Enter the sample ID using the on-screen keyboard or manual scan the barcode
with the barcode reader. If performing multiple STAT samples, place a check
next to “Start STAT when the analysis finished’. This will enable tube ejection at
the end of the sample analysis.
7. Mix the urine sample tube and insert (uncapped) into the sample holder, or
transfer a well-mixed urine to a sample cup.
a. If using a sample cup, set the sample cup in adapter No.368.
b. Dispense 0.6 ml. (13-18 drops) per sample cup.
8. Push in the STAT sample tube holder.
9. Touch [START] in the STAT Analysis box.
Caution: The sample tube holder is locked during STAT

analysis. Do NOT forcibly open the STAT sample tube holder or
press the release button. It may cause a malfunction of the
instrument.
10. The orange LED flashes and the “STAT Processing” message is displayed.
11. After aspiration completes, press the [Release] button to eject the sample.
a. If “Start STAT analysis of urine sample” was selected during the sample
programming, the sample will eject automatically.
b. Repeat steps 1-9 and repeat analysis.
12. Once sample analysis is complete, remove the sample. CV-11 will return to
ready.
VII Result Review

Results can be reviewed and managed on the Siemens Novus, UF-5000 and UD-10 on
their respective analyzers or on the UDM (Urinalysis Data Manager).
A. Reviewing test results on the Siemens CLINITEK Novus
The Patient Results screen displays a summary of the results after the system
finishes processing samples and (if necessary) missing data are entered. You can
specify the type of results you want to display (for example, all of the results or only
the results identified with errors) in the patient results summary.

Displaying Results Summaries
The results summary, sequence number, and status are displayed for each of ten
samples on each page of the Patient Results screen, starting with the most recent
sample. The following status indicator are possible:
 Completed: The sample was completed.
 Low Volume: the volume of sample in the tube is low.
 Dispense error: the system could not dispense the sample.
 Tube error: the tube is capped or too high.
1. To display all results or results by type, select an option:

a. All: displays all of the patient test results.
b. Error: displays the patient test that had errors.
c. Send error: displays only when the system could not send the patient test
results to the LIS, and if you configured the Host Data setting to send the
results automatically to the LIS>.
2. Use the scroll arrows to navigate the summary.
3. To view the details, print the summary or the details, or send the summary to the
LIS, select a function button.
Displaying Results Details
1. Select the [Details] function button on the Patient Results screen to display the
Patient Result Details screen.
2. Select [View] on the Patient Results Details screen. Detailed results for the first
sample are displayed.
3. Use the scroll buttons to the right of the summary to navigate the list. Information
is displayed in the Analytes area.
4. If the system cannot determine a valid analyte value, a result value of Error is
displayed for the analyte.
5. A symbol represents an analyte flag, which displays next to an analyte for a
sample that meets the following criteria.
Symbol
Description
^ Range adjusted
* Abnormal
† Sample quality
6. To display patient comments, print the details, or send the details to the LIS,
select a function button.

7. For more information on the results, refer to the Tables of Results section in the
appendix of the CLINITEK Novus Automated Urine Chemistry analyzer
Operator’s Guide.
B. Reviewing Test Results on the U5000 and UD-10

1. Touch the [Results List] icon on the [Menu] screen. The result confirmation
screen appears.
2. To review patient information – touch the [Patient] icon on the tool bar.
3. To review analysis information – touch the [Sample inf] icon on the tool bar.
4. To review Detailed Analysis on a result:
a. Touch the patient result in the Results List to highlight the specimen that
needs additional review.
b. Touch [Details] on the tool bar.
c. Check the detailed information displayed.
5. To delete the result – touch [delete] on the tool bar.
6. To output the result – touch [Out] on the tool bar.
7. To search for a result – touch [Find] on the tool bar.
8. To validate a result – touch [validate] on the tool bar.
VIII Analysis Registration and Review results on the UDM
A. Registering an analysis order (if not using LIS orders)

1. Click the [Order Entry] icon on the Main Menu Screen.
2. Click [Test Selection].
3. Select the profile and the parameters to be analyzed.
4. Click [OK] > [Save] > [OK].
B. Searching for patient information

1. Click the [Patient] icon on the Main Menu screen.
2. Click the [GO] button on the toolbar.
3. Select the search conditions
a. Patient ID
b. Patient name
c. Sex
4. Click [OK].
C. Searching for analysis results

1. Click the [Explorer] icon on the Main Menu screen.
2. Click the [Search] button on the tool bar.
3. Configure the search item
 Sample ID
 Patient ID

 Patient name
4. Click [Search]. If search is successful, patient results will appear on the
Explorer.
5. After reviewing patient results and information, click [X] to return to the previous
screen.
D. Checking Analysis results – Explorer

1. From the Maini Menu, click [Explorer] icon.
2. Search for patient using search conditions described previously or scan Explorer
screen. View Status Symbols to indicate analysis status.
3. Review Explorer screen for analysis results and patient info.

a. Rerun or cancel rerun on a sample.
1) Select the analysis for which to rerun or cancel rerun.
2) Click [Rerun] on the tool bar.
 Select [Profile] to retest a specific profile.
 Select [Rerun] to rerun the same profile.
 Select [Cancel] to cancel a rerun.
3) Click [OK].
b. Validate a sample
NOTE: Samples can be set to automatically validate after the results are
analyzed in the UDM settings.

1) Select the analysis for which to validate.
2) Click the [Validate] button on the tool bar.
 Select [Profile].
 Select [Validate] [will be available if not validated].
 Select [Unvalidate] [will be available only if validated and not sent to
the LIS].
3) Click [OK].
c. Edit a sample
You can edit patient information and order information. You can register or
assign a new order to change the sample number of, and enter report
comments for a sample without an order such as a sample which does not
have an order assigned or a barcode read error.
1) Select the analysis for which to edit.
2) Click the [Edit] button on the toolbar. A screen similar to the Order Entry
screen appears.
3) Enter information to be edited.
4) Click the [Save] button.
d. Outputting analysis results
1) Select the analysis for which to output.
2) Select the [In/Output] button on the toolbar.
 Select [Host output] to output validated parameters to a host
computer.
 Select [Report GP] to output validated parameters in report format.
 Select [List Printing] to output validated parameters in list format.
 Select [CSV] to output to a folder in .csv format.
E. Checking detailed information in Browser

1. From the Explorer screen, select the analysis for which to check details.
2. Click the [Browser] button on the toolbar.
a. Click [Main] for numerical data results.
b. Click [Graph] for Distributions and Scattergrams.
c. Click [Cumulative] for analysis results of patients over time.
d. Click [Rerun Results] for rerun analysis results of patient.
e.
NOTE: The options to modify, validate, rerun, output, and edit are also
available in the Browser Screen using the tool bar.
XI. Classifying and reporting particle images on the UDM

A. Viewing the particle images

1. Click the explorer icon on the Main Menu screen.
2. Select the sample whose particle image you want to review.
3. Click the [UD Manual] button on the tool bar to view the Overview screen.
a. Overview Tabs
1) Total display – Displays various comments on the analysis results for
UF5000 analysis results and scattergrams.
2) Image – Displays the image captured on the digital imaging device.
3) Graph – Displays the scattergrams from the analysis.
4) Order Information – Displays patient and order information.
b. Particle information area
1) Displays the image captured on the digital imaging device. Cells are
classified from Class 1 to Class 8 according to size.
c. Head Particle Image tab
1) Displays the particle image of each class
 Click each class to magnify the images
 Click the right arrow to move to the next image and the left arrow
for the previous image.
 Double click an image to enlarge.
d. Patient information area
1) Displays patient information.
B. Manually entering analysis results from the captured images.
NOTE: Results for the UD manual are strictly confirmatory and are never
numerical. Therefore result options such as “Present”, or “Confirmed” are
reportable.
1. Click the [Explorer] icon on the Main Menu screen.
2. Select the sample whose particle image you want to view and classify.
3. Click the [UD Manual] button on the toolbar to review the Overview screen.
4. In the particle information area, select the class in which you want to view and
classify the particle.
5. In the classification results list, double click the analysis parameter in which you
want to enter a result.
6. Click the analysis result that you want to enter from the result value list.
7. Click the [Close] button on the tool bar, then touch [Save]
C. Manually entering analysis results from the Count Pad
When a manual microscopic review is required because the analysis results of the
UF-5000 are not reportable, the Count Pad can be used to enter the numerical
results to the LIS. If the UD manual was previously ordered, the Count Pad results
will automatically cancel the UD manual order.
NOTE: The Count Pad must be configured in settings before results can be
reported.
1. Select and highlight the patient sample in Explorer Screen.
2. From the top tool bar, select [Count Pad].
3. The Count Pad result classification screen will appear.
4. Double click on the result and enter the appropriate value (either manually or
from the drop down box that was configured).
5. Continue entering results on remaining parameters.
6. Click the [Close] button on the tool bar, then click [Save].
D. Review Messages
Review messages and symbols alert the operator to reflex an additional test or hold
validation of analysis to review.
1. ERR – The analysis has been completed, but there are analysis parameters that
have been affected by errors.
2. REV – The analysis has been completed, but there are analysis parameters that
require confirmation.
3. [----] – Indicates that an analysis was not obtained due to an analysis error.
Marks do not appear.
4. [++++] – Indicates that results exceed the display range and cannot be displayed.
5. [*] – Low reliability mark. The reliability of the data is low. This is displayed on a
red background.
6. [*] – Outside of reference range and considered abnormal (Novus). This is
displayed on a yellow background.
7. [+] With a RED background. The value is higher than the set value of a [review
interval].
8. [+] With a YELLOW background. The value is higher than the set value of a
[reference interval].
X. Maintenance
A. Daily Maintenance
1. Shutdown entire system.
NOTE: the CLINITEK Novus does not require a shutdown
a. Make sure the UF-5000 is in the green “Sampler Ready state”
1) On the Main Menu screen, touch the [Shutdown] icon.
2) When the “Shutdown” dialog box appears, touch [YES].
3) Another “shutting down” dialog box will appear stating “Shutting down the
system…Please wait”.
4) Once Shutdown completes, the analyzer automatically turns off.
5) Power off the CV-11 sampler using the main power switch on the front of
the sampler.
b. Make sure the UD-10 is in the “Ready State”
1) Touch the [Menu] button on the toolbar, then touch [Shutdown] button.
2) Dispense 2 ml of CELLCLEAN™ into a sample cup.
3) Set the sample cup in the black adapter N. 368.

4) Press the release button on the sampler section. The STAT sample tube
holder slides out.
5) Set the CELLCLEAN cup and adapter into the STAT sample holder.
6) Push in the STAT sample holder, then touch [Execute] in the Shutdown
dialog box.
7) Shutdown takes approximately 10 minutes
8) Press the [stat] release button on the sampler section. The STAT
sample tube holder slides out.
9) Remove the CELLCLEAN from the STAT sample holder.
10) Push in the STAT sample tube holder
11) Press the CV-11 start-up switch for 2 seconds. The status indicator LED
goes out, and the power of the sampler section turns OFF.
c. Turn off the TH-11 decapper.
1) Press and hold the startup switch on the conveyor. The status indicator
LED goes out and the power of the TH-ll unit turns off.
d. Turn off the UDM
1) From the main screen touch [exit]. A dialog box appears
2) Click [OK].
3) Shut down windows. Computer will now turn off.
2. Siemens CLINITEK Novus Analyzer
a. Clean the SG Well
The cleaning cycle takes about 3 minutes to process. The system cleans
the SG well as part of the calibration procedure.
1) Pour at least 2 mL of 5.25% sodium hypochlorite (house bleach) into
a sample tube and label “Bleach”.
2) Place the tube of bleach in the 1st test position in a rack.
3) Press the start/stop switch on the conveyor. The indicator light will
turn orange
4) Please the rack on the right sampler pool.
5) Select [System] > [Clean SG Well].
6) Select [Start].
After the system finished cleaning, a message displays that the cleaning
cycle is complete.
3. UF-5000
a. Checking for fluid in the trap chamber
1) Open the upper and lower front covers of the analyzer by lifting the
upper cover and pushing the buttons to release the lower cover.
2) Check to see if any fluid has accumulated in the Trap Chamber.
3) If there is no fluid in the trap chamber, close the covers.
4) If there is fluid in the trap chamber, follow the procedure below:

Shutdown the analyzer.
Turn the trap chamber clockwise to remove it and dispose of the
fluid collected in the chamber.
 Reinstall the O-ring and the float, pointed side up.
 Install the trap chamber by turning it counter clockwise.
 Close the upper and lower front covers.
 Start-up the UF-5000.
NOTE: If fluid continues to accumulate in the trap chamber, contact
Sysmex Technical Assistance Center for assistance.
4. UD-10
a. Checking for fluid in the trap chamber on the UD-10
1) Open the top front cover of the UD-10
2) Check to see if any fluid has accumulated in the trap chamber.
3) If there is no fluid in the trap chamber, close the cover.
4) If there is fluid in the trap chamber, follow the procedure below:
 Shutdown the analyzer.
 Turn the trap chamber clockwise to remove it.
 Reinstall the O-ring and the float, pointed side up.
 Install the trap chamber by turning it counter clockwise.
 Close the upper and lower front covers.
 Start up the UD-10.
NOTE: If fluid continues to accumulate in the trap chamber, contact
Sysmex Technical Assistance Center for assistance.
B. Weekly Maintenance
a. SG/Clarity Sensor Cleaning Procedure
1) Turn the Novus off using the power switch.
2) Open the system door.
3) Fill a beaker, cup, or suitable vessel with hot tap water (90º - 110ºF / 32º -
43ºC.
4) Use a plastic pipette or dropper to manually dispense the hot water into
the SG well.
Notes:
 Do NOT remove the SG/clarity sensor from the instrument.
 Place the tip of the plastic pipette over the sensor well making sure
that the tip doesn’t touch the SG sensor.
 Dispense the hot water into the SG well with three full plastic pipettes
of hot water.
5) Close the system door and switch the power back on.

6) Run the [Clean SG well] procedure in the [System] menu.
2. UF-5000 and UD-10
a. Clean the rinse bottle
1) Remove the cap from the rinse water bottle on each analyzer.
2) Pull out the spout kit straight up.
3) Discard the rinse water in the bottle
4) Use tap water to wash the inside of the bottle and the spout kit, and
then rinse them with rinse water.
5) Replenish the rinse water.
6) Insert the spout kit straight into the rinse bottle.
7) Close the cap of the rinse bottle.
C. As needed Maintenance
a. Prime the pump
This primes the syringe pump with rinse solution and should be performed:
 When you refill the rinse bottle.
 If air bubbles appear in the rinse solution line.
 If the analyzer has been powered off for greater than 1 hour.
 When an error message indicates that you should prime the pump.
1) Select [System] from the Home screen.
2) Select [prime pump].
b. Empty the waste bottle
CAUTION: RISK OF INFECTION
Do not dispose waste fluid while instrument mechanisms
are in motion, such as during analysis. Waste fluid
could spray out of the tube and onto your skin or clothes
causing a risk of infection by pathogens or other
contaminates. Dispose of waste fluid according to local
disposal guidelines. Always wear the proper PPE when
handling fluids contaminated with body fluids and other
contaminates.
The bottle is inspected visually for volume. Dispose waste when bottle is
80% full.
1) Remove the cap and disconnect the tubing from the external waste bottle.
2) Empty the remaining waste from the waste bottle. Dispose of waste
according to your laboratory and biohazard guidelines.
3) Wipe off the waste bottle to dry it.

4) Reconnect the tubing.
c. Empty the Card Waste Drawer
The system detects when the card waste drawer is full or empty
1) Remove the racks from the rack handler.
2) To release the latch, press the latch and pull the card waste drawer
toward you. Slide the drawer all the way out of the slot.
3) Dispose the used test cards according to your laboratory and biohazard
guidelines.
4) Remove the internal liner.
5) Press the ridges of the liner on the bottom of the drawer.
6) Lift up the liner and slide it out of the drawer.
7) Clean the liner with isopropyl alcohol.
8) Replace the internal liner into the card waster drawer.
9) Slide the drawer into the slit until the drawer is fully closed and latched.
For the following Periodic Maintenance Tasks, refer to the CLINITEK
Novus Automated Urine Chemistry Analyzer Operator’s Guide
 Cleaning the card platform
 Cleaning the moisture gate
 Cleaning the card grippers
 Cleaning the pad sensor
2. UF-5000
a. Replace Rinse Water (see section III A-6) in this procedure.
b. Cleaning
NOTE: Cleaning is automatically performed when shutdown is executed.
You can also perform cleaning without shutdown to restore the
instrument to the same condition as after startup
1) Make sure the instrument is in the ready state for sampler analysis or
STAT analysis.
2) Touch the [Rinse] icon on the [Maintenance Menu] screen.
3) Touch [Yes].
c. Rinsing the Flow cell
STAT analysis
2) Touch the [Rinse Flow cell] icon on the [Maintenance Menu] screen.
3) Dispense CELLCLEAN into a sample tube or sample cup.
NOTE: when using the sample cup, set the sample cup in adapter NO.
368.
4) Set the sample tube or sample cup into the STAT sample holder
5) Push in the STAT sample tube holder.

6) Touch [Execute].
7) When the sampler (CV-11) is connected, press the release button on the
CV-11.
8) Remove the CELLCLEAN from the STAT sample holder.
9) Push in the STAT sample tube holder.
10) The process takes approximately 8 minutes. When finished, the dialog
box closes.
d. Disposing of waste fluid in the waste tank
When using the waste tank (optional), an error occurs when the tank is full.
Dispose of the waste fluid in the tank immediately.
STAT analysis.
2) Remove the cap from the waste tank.

Do not dispose waste fluid while instrument mechanisms
are in motion, such as during analysis. Waste fluid could
spray out of the tube and onto your skin or clothes causing
a risk of infection by pathogens or other contaminates.
Dispose of waste fluid according to local disposal
guidelines. Always wear the proper PPE when handling
fluids contaminated with body fluids and other
contaminates.
3) Dispose of the waste fluid.

4) Rinse the waste tank.
5) Disinfect the tank with alcohol.
6) Close the cap of the waste tank.
e. Rinsing/replacing the sample filter
If the sample filter is clogged or dirty, the specified amount of sample cannot
be aspirated and an error occurs. When an error occurs, rinse or replace the
sample filter.
Be sure to wear adequate personal protective equipment when
performing this procedure as there is a risk of infection by
pathogens or other contaminates.
WARNING:
Be sure to shut down the instrument before rinsing or replacing
the sample filter. Otherwise, there is a risk of electrical shock.
STAT analysis.

2) Touch the [Maintenance] icon on the MENU screen.
3) Touch the [Sample filter] icon.
4) Touch [Execute].
5) Wait 1 minute to allow the pressure to fall inside the instruments.
6) Open the front upper cover.
7) Remove the front lower cover. (See UF-5000 Troubleshooting Manual for
instructions on how to remove cover)
8) Remove the sample filter case from the holder. Have a dry cloth ready in
case fluid leaks from the tube when removing the filter.
9) Remove the tube adapters from the top and bottom of the sample filter by
turning the top adapter counter clockwise and the bottom adapter
clockwise.
10) Remove the cap from the sample filter being careful not to drop the filter
inside the case.
11) Remove the filter from the sample filter case and rinse it with purified
water.
12) Carefully dry the filter and inspect for clogging inside the hole. If filter is
still clogged – repeat the rinsing. If clog cannot be removed, replace the
filter.
13) Set the rinsed or new filter in the sample filter case, and attach the cap.
14) Install the tube adapters onto the top and bottom of the filter.
15) Install the sample filter case into the holder.
16) Attach the analyzer covers.
17) Turn on the analyzer.
18) Perform QC analysis and check the following points.
 A short sample error does not occur.
 There is no fluid leakage from the filter.
 There is no abnormality with the QC analysis.
19) If any of the above errors occur, reassemble the sample filter.
f. Replace the fuses
See the UF-5000 troubleshooting manual for instructions on replacing the
fuses.
3. UD-10
a. Performing cleaning
Cleaning consists primarily of rinsing the analysis line and pipette.
STAT analysis.
2) Touch the [Rinse] icon on the [Maintenance Menu] screen.

3) Touch [YES].
b. Cleaning the imaging cell
STAT analysis.
2) Touch the [Cell Rinsing] icon on the [Maintenance Menu] screen.
3) Dispense CELLCLEAN into a sample cup.
4) Set the sample cup in the adapter No. 368.
5) Place the CELLCLEAN in the STAT sample holder.
6) Push in the STAT sample tube holder until it locks.
7) Touch [Execute].
 Rinsing starts.
 The progress dialog box appears.
 Once CELLCLEAN is complete, the STAT sampler tube holder lock is
automatically released.
8) Press the release button on the sampler section.
9) Imaging cell clearing takes about 10 minutes. Once complete, the
[Background Check] dialog box appears and a background check starts.
10) Check the results of the Background count.
c. Replenish the rinse water
See Section III, A-6 in this document.

d. Disposing of waste fluid in the waste tank
When using the waste tank (optional), an error occurs when the tank is full.
Dispose of the waste fluid in the tank immediately.
Do not dispose waste fluid while instrument mechanisms are in motion, such as
during analysis. Waste fluid could spray out of the tube and onto your skin or
clothes causing a risk of infection by pathogens or other contaminates.
Dispose of waste fluid according to local disposal guidelines. Always wear the
proper PPE when handling fluids contaminated with body fluids and other
contaminates.
STAT analysis.
2) Remove the cap from the waste tank.
3) Dispose of the waste fluid
4) Rinse the waste tank.
5) Disinfect the waste tank with alcohol.
6) Close the cap of the waste tank.
e. Replacing the fuses
See UD-10 Troubleshooting Manual for instructions on how to replace the
fuses.
4. TH-11
Always wear protective gloves, glasses and lab coat for cleaning work. In
addition, wash your hands with an antiseptic cleanser after the work. There
is a risk of infection from areas that have come into contact with urine.
There is also the possibility of electrical shock and burn injury due to short
circuit.
The cover of the trashbox is classed as infectious material. Handle it with
care.
If urine has stuck to the outer surface or base of the trashbox, wipe it off.
Urine may spill out of the instrument, risking contamination.
a. Cleaning
1) Clean the surface of the instrument by wiping with a soft, dry cloth, or
a cloth moistened with distilled water or diluted (0.05% or 0.5%)
bleach solution.
b. Cap disposal after decapping.
 The TH-11 temporarily stores caps after decapping in a trash box or
within the wagon.

 The TH-11 keeps an internal count of the number of caps it has
decapped, and when the count exceeds a certain number, it uses a
“cap disposal count exceeded error” to prompt disposal of caps.
o When there is no wagon – 200 pieces.
o When there is a wagon – 800 pieces.
 If a cap disposal error occurs, follow the procedure below to dispose
of caps.
When using a bench top:
1) Press the alarm reset switch on the TH-11.
2) Remove the trashbox from the TH-11.
3) Open the cover of the trashbox and discard the bag filled with caps
4) Fit a bag over the trashbox.
5) Close the cover of the trashbox.
6) Put the trashbox back in the TH-11.
7) Press the start switch on the TH-11.
When using a wagon:

1) Press the alarm reset switch on the TH-11.
2) Open the front door of the trashbox and discard the bag filled with
caps.
3) Discard caps in the trashbox.
4) Replace the trashbox in the trashbox placement positions.
5) Close the front door of the wagon (WG-46).
6) Press the start switch on the TH-11.
XI. Checking Log History on the UDM

You can check the logs of this product and logs of the connected Novus chemistry
analyzer, urine quantitative analyzer or digital imaging device.
A. Check the [HISTORY] icon on the [Main Menu]
1. Click the [HISTORY] icon on the [Main Menu] screen.
2. Select the analyzer.
3. Click the tab of the history you want to check on the bottom of the [History]
screen.
a. Operation detail tab. Displays the history of operations.
b. Error history tab. Displays the history of errors that have occurred.
c. Reagent Replacement History. Displays the history of reagent replacement.
d. Maintenance history. Displays the history of performed on board
maintenance.
B. Setting filter conditions for a history
1. Click the [History] icon on the [Main Menu] screen.
2. Select analyzer in the analyzer selection area.
3. Click the tab of the history you want to check.
4. Click the [Filter] button on the toolbar.
5. In the filter condition selection area, select the checkbox of the condition that you
want to set and click [Select].
6. Set the filter conditions and click [OK]. The dialog box closes.
C. Saving a log in CSV format
1. Click the [History] icon on the [Main Menu] screen.
2. Select the analyzer.
3. Click the tab of the log that you want to display.
4. Select the log that you want to save.
5. Select the [Output] button on the toolbar and click [CSV output].
6. Specify a folder, or create a new folder.
7. Enter a file name.
8. Click [Save].
c. Reporting results
Each laboratory should determine its own reference range(s) for the diagnostic
evaluation of patient results
Novus Table of Results.

The tables of results include conventional and System International (SI) with and without
the Plus System. If the system cannot determine a valid analyte, a results value of Error
displays for the analyte
Conventional Units – ASTM and HL7 results

Test Abbreviation Conventional Conventional with
Plus System
Color COL Yellow Yellow
Dark yellow Dark yellow
Orange Orange
Red Red
Green Green
Other Other
Clarity CLA Clear Clear
Cloudy Cloudy
Turbid Turbid
Sl. Cloudy* Sl. Cloudy*
Glucose GLU Negative Negative
100 mg/dl Trace
250 mg/dl 1+

500 mg/dl 2+
>=1000 mg/dl 3+
Bilirubin BIL Negative Negative
Small 1+
Moderate 2+
Large 3+
Ketone KET Negative Negative
Trace Trace
15 mg/dl 1+
40 mg/dl 2+
80 mg/dl 3+
>=160 mg/dl 4+
Conventional Units continued

Test Abbreviation Conventional Conventional with
Plus System
Specific Gravity SG <= 1.005 to >=1.030 <= 1.005 to >=1.030
0.005 units In increments of 0.005 units In increments of 0.005 units
Specific Gravity SG 1.000 to >= 1.099 1.000 to >=1.099
0.001 units In 0.001 increments In 0.001 increments
Occult Blood BLO Negative Negative
Trace Trace
Small 1+
Moderate 2+
Large 3+
NH NH
pH pH 5.0 to 9.0 5.0 to 9.0
In increments of 0.5 In increments of 0.5
Protein PRO Negative Negative
Trace Trace
30 mg/dl 1+
100 mg/dl 2+
300 mg/dl 3+
>=1000 mg/dl 4+
Urobilinogen URO 0.2 E.U./dl 0.2 E.U./dl
1.0 E.U./dl 1.0 E.U./dl
2.0 E.U./dl 2.0 E.U./dl
4.0 E.U./dl 4.0 E.U./dl

>=8.0 E.U./dl >=8.0 E.U./dl
Nitrite NIT Negative Negative
Positive Positive
Leukocytes LEU Negative Negative
Trace Trace
Small 1+
Moderate 2+
Large 3+
SI Units – ASTM and HL7 Results

Test Abbreviation SI SI with Plus
System
Color COL Yellow Yellow
Dark Yellow Dark Yellow
Orange Orange
Red Red
Green Green
Other Other
Clarity CLA Clear Clear
Cloudy Cloudy
Turbid Turbid
Sl. Cloudy* Sl. Cloudy*
Glucose GLU Negative Negative
5.5mmol/L Trace
14 mmol/L 1+
28 mmol/L 2+
>=55 mmol/L 3+
Bilirubin BIL Negative Negative
Small 1+
Moderate 2+
Large 3+
Ketone KET Negative Negative
Trace Trace
1.5mmol/L 1+
3.9mmol/L 2+
7.8mmol/L 3+
>=15.6 mmol/L 4+
Specific Gravity SG <= 1.005 to >=1.030 <= 1.005 to >=1.030
0.005 Units In increments of 0.005 units In increments of 0.005

units
<= 1.005 to >=1.030 SG 1.000to >=1.099 1.000to >=1.099
In increments of in increments of 0.001 in increments of 0.001
0.001 units
Occult Blood BLO Negative Negative

Trace_Lysed Trace_Lysed
Ca 25 Ery/ul 1+
Ca 80 Ery/ul 2+
Ca 200 Ery/ul 3+
Trace-Intact Trace-Intact
Test Abbreviation SI SI with Plus

System
pH pH 5.0 to >=9.0 5.0 to >=9.0
In increments of 0.5 In increments of 0.5
Protein PRO Negative Negative
Trace Trace
0.3g/L 1+
1.0 g/L 2+
3.0 g/L 3+
>=10.0 g/L 4+
Urobilinogen URO 4.2 µmol/L 3.2 µmol/L
16 µmol/L 16 µmol/L
>=131µmol/L >=131µmol/L
Nitrite NIT Negative Negative
Positive Positive
Leukocytes LEU Negative Negative
Ca 15 Leu/µ Trace
CA 70 Leu/µ 1+
CA 125 Leu/µ 2+
Ca 500 Leu/µ 3+
Units for Reporting Results

Add your laboratory specific reporting units for each test in the table below:
TEST REPORT
Glucose Add your laboratory – specific reporting units
Bilirubin Add your laboratory – specific reporting units
Protein Add your laboratory – specific reporting units
pH 5.0 – 8.5 (in 0.5 increments)
Blood Add your laboratory – specific reporting units
Ketone Add your laboratory – specific reporting units
Urobilinogen Add your laboratory – specific reporting units
Nitrite Add your laboratory – specific reporting units
Leukocyte Add your laboratory – specific reporting units
Specific Gravity Add your laboratory – specific reporting units
Color Yellow, Straw, Dk Yellow, Amber, Orange, Red, Green, Other
Clarity Clear, Slightly Cloudy, Cloudy, Other
Reference Intervals for Random Urine Specimens

(Add your laboratory-specific expected values here)
Test Report
Glucose Add your laboratory specific expected values
Bilirubin Add your laboratory specific expected values
Protein Add your laboratory specific expected values
pH Add your laboratory specific expected values
Occult Blood Add your laboratory specific expected values
Ketone Add your laboratory specific expected values
Urobilinogen Add your laboratory specific expected values
Nitrite Add your laboratory specific expected values
Leukocytes Add your laboratory specific expected values
Specific Gravity 1.003 – 1.030*
Color Add your laboratory specific expected values
Clarity Add your laboratory specific expected values
(optional)
*If SG increments of 0.001 were selected in Set Up Analyzer. However, if SG
increments of 0.005 were selected in Set Up Analyzer, the range should be <=1.005 to
>=1.030.
Complete this section with your Laboratory’s (Normal) Reference Ranges
Reference Range Urinalysis (Male)
Parameter Reference Range
RBC
WBC

Epithelial Cells
Casts
Bacteria
Reference Range Urinalysis (Female)
Parameter Reference Range
RBC
WBC
Epithelial Cells
Casts
Bacteria
Acceptable Reporting Format
Complete this section with your laboratory’s reporting format: acceptable units, grading
criteria, etc.
Reporting Abnormal Results to Physicians:

Complete this section with your laboratory’s procedure for reporting abnormal results.
This may include criteria for specimen repeats, recollection, specimen rejection,
laboratory (including manual and pathology) review, results to be called and footnoting of
reports, etc.
XII. Limitation of Procedure

A. CLINITEK Novus
Enter your laboratory specific criteria for Confirmatory testing and Sediment reflex
testing (UF-5000 analysis)
Test Confirmatory Value Sediment Reflex Value

Glucose
Bilirubin
Protein
pH
Blood
Ketone
Urobilinogen
Nitrite
Leukocyte
Specific Gravity
Color
Clarity
CLINITEK Novus Optical System

There are inherent differences between the colors that are perceived by the human
eye and that are detected by any instrumental optical system. The human eye is
capable of detecting minute differences in shade and very small areas of color;
artificial optical systems are less sensitive to such small changes. Conversely,
analyzer optics are capable of detecting certain colors that are masked by or blended

with other colors to the human eye. For this reason, exact agreement between
visual results and analyzer results might not be obtained. However, agreement is
generally within one reported level and is equal to or better than the agreement
between two visual readers. Agreement of urine color is generally within one step
along the chromatic scale.
Interfering substances
For all tests, false positive results (increased values) and/or false negative results
(decreased values) can occur when substances that cause abnormal urine color are
present, such as:
 Visible levels of blood or bilirubin
 Drugs containing dyes
 Nitrofurantoin
 riboflavin
Limitations given for the reagents include specific substances and conditions that
may affect the test results. As with all laboratory tests, definitive diagnostic or
therapeutic decisions should not be based on any single results or method.
Substances that cause abnormal urine color may affect the readability of reagent
areas on urinalysis reagent strips. These substances include visible levels of blood
or bilirubin, drugs containing dyes (for example, Pyridium, Azo Gantrisin, Azo
Gantanol), nitroturantoin (Macrodantin, Furadantin), and riboflavin
Protein: false positive results may be obtained with highly buffered or alkaline urine,
Blood: Captopril (Capoten) and other compounds containing sulfhydryl groups may
reduce the sensitivity. Certain oxidizing contaminants, such as hypochlorite, may
produce false positive results. Microbial peroxidase associate with urinary tract
infection may cause a false positive reaction.
Leukocytes: Elevated glucose concentrations (≥3 g/dL or 160 mmol/L) may cause
decreased test results. The presence of cephalexin (Keflex), cephalothin (Keflin), or
high concentrations of oxalic acid may also cause decreased test results.
Tetracycline may cause decreased reactivity, and high levels of the drug may cause
a false negative reaction. Positive results may occasionally be due to contamination
of the specimen by vaginal discharge.
Nitrite: A negative results does not rule out significant bacteriuria. False negative
results may occur with shortened bladder incubation of the urine, absence of dietary
nitrate, or the presence of nonreductive pathological microbes. The presence of
color precipitates may cause a false positive result.
Glucose: Urine samples with a pH of 9.0 and greater will cause falsely elevated
glucose results.
Ketone: False trace results may occur with highly pigmented urine specimens or
those containing large amounts of levodopa metabolites. Compounds that contain
sulfhydryl groups, such as mesna (2-mercaptoethane sulfonic acid) and captopril,
may cause false positive results or an atypical color reaction.

pH: Bacterial growth by certain organisms in a specimen may cause a marked
alkaline shift (pH > 8.0), usually because of urea conversion to ammonia.
Bilirubin: Indican (indoxyl sulfate) can produce a yellow-orange to red color

response that may interfere with the interpretation of a negative or positive reading.
Metabolites of etodolac (Lodine) may cause false positive or atypical results.
Atypical colors may indicate the presence of bile pigment abnormalities and the urine
specimen should be tested further.
Urobiinogen: The reagent area may react with interfering substances known to
react with Ehrlick’s reagent, such as ρ-aminosalicylic acid and fulfonamides. False
negative results may be obtained if formalin is present. The test is not a reliable
method for the detection of porphobilinogen.
Color: Because of the inherent differences between the perception of the human
eye and the optical system of the instrument, there may be differences between the
color that is perceived visually and that is reported by the instrument, especially
when there are low levels of a color present.
Add your laboratory specific expected values

B. UF-5000
Manufacturers Stated Reportable Ranges
Formed Element Reportable Range
RBC 2.0 – 10,558/ul
WBC 1.8 – 5,548/ul
EC (Epithelial Cell) 1.4 – 201.7/ul
CAST 1.41 – 21.83/ul
BACT (Bacteria) 4.5 – 9,821/ul
1. Samples that exceed the reportable ranges may be diluted with UF-
CELLSHEATH or saline. Repeat analysis should be performed and results
should be multiplied for final results.
2. Samples with the following conditions may not recover correct results:
 High Density samples with pyuria.
 Macroscopic hematuria samples.
 Samples that include fluorescent matter due to the inclusion of chemicals.
 Samples that include preservatives.
 Samples consisting of pooled urine.
 Samples incorporating bubbles.
 Samples that have changed due to long-term storage.
 Samples with high turbidity.
 Samples with a high concentration of mucus strands.
C. There are no reportable ranges for the UD-10
1. Samples with the follow conditions may not recover correct results.
 Samples that have changed due to long-term storage.
 Samples that have high turbidity.
 High density samples with pyuria.
 Samples consisting of pooled urine.
 Macroscopic hematuria samples.
 Samples with a high concentration of mucus strands.
 Samples incorporating bubbles.
XIII References
1. UF-5000 Basic Operation, Sysmex Corporation, N. American Edition, Kobe, Japan
2. UF-5000 General Information, Sysmex Corporation, N. American Edition,
Kobe,Japan
3. UF-5000 Troubleshooting, Sysmex Corporation, N. American Edition, Kobe,Japan
4. UD-10 Basic Operation, Sysmex Corporation, N. American Edition, Kobe,Japan
5. UD-10 General Information, Sysmex Corporation, N. American Edition, Kobe, Japan
6. UD-10 Troubleshooting, Sysmex Corporation, N. American Edition, Kobe,Japan
7. UDM Instructions for Use, Sysmex Corporation, N. American Edition, Kobe, Japan
8. UF CONTROL ASSAY SHEET, Sysmex Corporation, Kobe Japan
9. Material Safety Data Sheets, Sysmex Corporation, Kobe, Japan
10. Product inserts and reagent packaging. Sysmex Corporation, Kobe, Japan.
11. CLINITEK Novus Automated Urine Chemistry Operator’s Guide. Siemens
Healthcare Diagnostics, Elkhart IN. 46515
12. CLINITEK Novus 10 urinalysis cassette package insert. Siemens Healthcare
Diagnostics, Elkhart, IN 46515
13. CLINITEK Novus Calibration Kit package insert. Siemens Healthcare Diagnostics,
Elkhard, IN 46515
14. National Committee for Clinical Laboratory Standards (NCCLS). Clinical Laboratory
Procedure Manuals – Third Edition (GP2-A3), 1996.
15. Urine Sample Transportation Unit [CV-11] Urine Sample Decapper Unit [TH-11]
Instructions for Use. .
Supersedes: Procedure titled__________________________


UN-Series With Novus Chemistry Analyzer CLSI Rev3

Uploaded by

Document Information

Original Title

Copyright

Available Formats

Share this document

Share or Embed Document

Sharing Options

Did you find this document useful?

Is this content inappropriate?

Copyright:

Available Formats

UN-Series With Novus Chemistry Analyzer CLSI Rev3

Uploaded by

Copyright:

Available Formats

Sysmex UN-Series™

Automated Urinalysis Solution

Document Number: 1519–LSS

Disclaimer: This procedure is to be used only as an EXAMPLE. It is SOLELY the

Sysmex America Inc.

Replaces method of Date: _____________________________

Prepared by: _______________________________________Date_____________________

Supersedes: Procedure Titled_________________________________________________________________

The CLINITEK Novus Automated Urine Chemistry Analyzer is a fully automated

Sysmex UN-Series CLSI Procedure

Bilirubin The coupling of bilirubin with diazotized dichloroanitine in a

Blood Peroxidase-like activity of hemoglobin, which catalyzes the

Glucose Double sequential enzyme reaction. Glucose oxidase

Ketone The reaction of nitroprusside with acetoacetic acid.

Leukocytes Granulocytic leukocytes contain esterases that catalyze the

Nitrite Conversion of nitrate (derived by diet) to nitrite by the action

pH Double indicator principle that gives a broad range of colors

Protein At a constant pH, the presence of protein causes a change in

Urobilinogen p-diethylaminobenzaldehyde in conjunction with a color

Sysmex UN-Series CLSI Procedure

Test Codes Reportable Parameters

RBC Red Blood Cells

WBC White Blood Cells

EPI Epithelial Cells

CAST Hyaline Casts

TEST CODE FLAGGED PARAMETERS*

YLC Yeast Like Cells

PATH CAST Pathological Cast

*Flagged parameters are not directly reportable from the analyzer.

Sysmex UN-Series CLSI Procedure

Displayed Items Particle Image Size

Sysmex UN-Series CLSI Procedure

B. Unacceptable urine specimens including those listed below should not be

Sysmex UN-Series CLSI Procedure

REAGENT ANALYZER(S) OPEN STABILITY

Sysmex UN-Series CLSI Procedure

UF-CELLSHEATH Active ingredients

UF-CELLSHEATH disposal procedures

UF-CELLPACK SF Active ingredients

UF-CELLPACK SF disposal procedures

UF-CELLPACK CR Active Ingredients

UF-CELLPACK CR disposal procedures

UF-Fluorocell SF Active Ingredients

UF-Fluorocell SF Disposal Procedures

Sysmex UN-Series CLSI Procedure

UF-Fluorocell CR Active Ingredients

UF-Fluorocell CR Disposal Procedures

Sysmex UN-Series CLSI Procedure

Cassette storage and handling

Cassette disposal procedures

NOTE: This material is not considered hazardous by the OSHA Hazard

9. CLINITEK Atlas Positive and Negative Controls

Control Storage and handling

Sysmex UN-Series CLSI Procedure

NOTE: This material is not considered hazardous by the OSHA Hazard

10. CLINITEK Novus Calibration Kit

Calibrator storage and handling

Calibrator disposal procedures

Sysmex UN-Series CLSI Procedure

UF CONTROL Active Ingredients

UF CONTROL Disposal Procedure

CAUTION: For in vitro diagnostic use only. Do not ingest. If ingested,

Recommended: Wear PPE equipment for protection, and to prevent

Prepared by: ___________________Date_