Arkray AUTION ELEVEN AE-4022 User manual

AE-4022 i
1 Introduction
Thank you for purchasing the AUTION ELEVEN model AE-4022 Urine Analyzer as part of the AUTION
ELEVEN Semi-Automated Urinalysis Test System.
Read this manual thoroughly before using the instrument. This operating manual gives an outline of the
system and the proper procedures for operation, maintenance and troubleshooting. Follow the instructions
in the manual in order to maintain the instrument warranty.
© 2015 ARKRAY, Inc.
• It is strictly prohibited to copy any part of this reference manual without the expressed consent of ARKRAY, Inc.

AE-4022 ii
2 Table of Contents
1. Introduction .................................................................................................... i
2. Table of Contents .......................................................................................... ii
3. PREMISE ........................................................................................................ v
Intended Use ............................................................................................................... v
Technology and Scientific Principles...........................................................................vi
Biological Principles*1 ............................................................................................... viii
4. For Your Safety and Product Performance................................................. x
Electrical Compliance.................................................................................................. x
Caution in Handling Specimens .................................................................................. x
Symbols.......................................................................................................................xi
Caution Labels ........................................................................................................... xii
Environmental Conditions ......................................................................................... xiv
Specimen Collection.................................................................................................. xiv
Materials Provided......................................................................................................xv
Materials Necessary.................................................................................................. xvi
Quality Control........................................................................................................... xvi
Limitations ................................................................................................................. xvi
Chapter 1. Before Using the AE-4022 1-1
1.1. Outline of the AE-4022 ............................................................................1-2
1.1.1. AE-4022 Features ..................................................................................... 1-2
1.1.2. Measurement types................................................................................... 1-4
1.1.3. Specifications ............................................................................................ 1-5
1.2. Name and function of each part.............................................................1-6
1.2.1. Front side .................................................................................................. 1-6
1.2.2. Rear side................................................................................................... 1-7
1.2.3. Display ...................................................................................................... 1-8
1.2.4. Operator panel ........................................................................................ 1-10
1.3. Installing the instrument.......................................................................1-11
1.3.1. Precautions for installation ...................................................................... 1-11
1.3.2. Installation of the instrument ................................................................... 1-12
1.3.3. Starting and ending operation after installation....................................... 1-16
Chapter 2. Measurement Operation 2-1
2.1. Outline of measurement operation ........................................................2-2
2.1.1. Measurement operational flow .................................................................. 2-2
2.1.2. Measurement ............................................................................................ 2-3

AE-4022 iii
2.2. Measurement precautions ......................................................................2-4
2.2.1. Precautions for operation .......................................................................... 2-4
2.2.2. Precautions for handling samples ............................................................. 2-4
2.2.3. Precautions for handling test strips ........................................................... 2-5
2.3. Preparation for measurement ................................................................2-6
2.3.1. Check before measurement...................................................................... 2-6
2.3.2. Starting the instrument .............................................................................. 2-8
2.3.3. Setting measurement conditions............................................................. 2-10
2.3.4. Entering your operator ID number........................................................... 2-12
2.3.5. Sample preparation................................................................................. 2-13
2.3.6. Entering patient ID numbers ................................................................... 2-14
2.4. Measurement operation ........................................................................2-17
2.4.1. Normal measurement.............................................................................. 2-17
2.4.2. STAT measurement ................................................................................ 2-22
2.4.3. Control measurement.............................................................................. 2-27
2.4.4. Check measurement ............................................................................... 2-32
2.5. How to read the measurement results ................................................2-37
Chapter 3. Supplementary Operations 3-1
3.1. Outline of menu screen...........................................................................3-2
3.1.1. How to operate the menu screen .............................................................. 3-2
3.1.2. Menu list.................................................................................................... 3-3
3.2. MODE (measurement mode selection)..................................................3-4
3.3. MEMORY (reprinting and resending measurement results) ...............3-6
3.4. DATE (setting the date and time) .........................................................3-11
3.5. LIST (printing a list of abnormal measurement results) ....................3-13
3.6. STRIP (selecting the test strip type) ....................................................3-15
3.7. SETUP (user settings)...........................................................................3-17
3.7.1. Operation of user settings ....................................................................... 3-17
3.7.2. List of settable items ............................................................................... 3-18
3.7.3. No.000: Printing of parameter item numbers .......................................... 3-20
3.7.4. No.001: Printing of parameters ............................................................... 3-21
3.7.5. No.002: Test strip type............................................................................ 3-22
3.7.6. No.003: Measurement result format........................................................ 3-24
3.7.7. No.004: Test strip placing direction......................................................... 3-26
3.7.8. No.005: Operational mode when turning ON .......................................... 3-27
3.7.9. No.006: Buzzer sound ON/OFF .............................................................. 3-28
3.7.10. No.007: Printing of abnormal marks........................................................ 3-29
3.7.11. No.008: Initialization of measurement number when turning ON............ 3-30
3.7.12. No.009: Printer use ................................................................................. 3-31

AE-4022 iv
3.7.13. No.010: Number of sheets to print .......................................................... 3-32
3.7.14. No.011: Number of line breaks ............................................................... 3-33
3.7.15. No.012: Additional data........................................................................... 3-34
3.7.16. No.013: External output ON/OFF............................................................ 3-35
3.7.17. No.014: Barcode output range setting .................................................... 3-36
3.7.18. No.016: Operator ID number management............................................. 3-38
3.7.19. No.017: Operator ID function ON/OFF.................................................... 3-43
3.7.20. No.018: Operator ID number effective time ............................................ 3-45
3.7.21. No.019: Printing of operator ID numbers with results ............................. 3-46
3.7.22. No.020: QC deadline............................................................................... 3-47
3.7.23. No.021: QC lock-out function ON/OFF ................................................... 3-50
3.7.24. No.022: Clarity input function ON/OFF ................................................... 3-52
3.7.25. No.090: Printing of a trouble list .............................................................. 3-53
3.7.26. No.099: Initialization of parameters......................................................... 3-54
Chapter 4. Maintenance 4-1
4.1. Daily maintenance ...................................................................................4-2
4.1.1. Cleaning the feeder................................................................................... 4-2
4.1.2. Cleaning the waste box........................................................................... 4-10
4.2. Replacing the thermal recording paper...............................................4-12
4.3.
Maintenance of the instrument when it will not be used for a long period ..4-15
Chapter 5. Troubleshooting 5-1
5.1. Warning messages..................................................................................5-2
5.2. Error messages .......................................................................................5-3
5.3. Trouble messages ...................................................................................5-5
Chapter 6. Appendix 6-1
6.1. Rank tables ..............................................................................................6-2
6.2. Performance characteristics ..................................................................6-4
6.3. External output specifications ...............................................................6-5

AE-4022 v
3PREMISE
Intended Use
The AUTION ELEVEN Semi-Automated Urinalysis System provides qualitative and semi-quantitative
measurements for glucose, protein, bilirubin, urobilinogen, pH, blood, ketones, nitrites, leukocytes, specific
gravity and color tone in urine specimens. The system is intended for in vitro diagnostic use in screening
patient populations found in clinical laboratories.
The AUTION ELEVEN Semi-Automated Urinalysis System consists of the following:
AUTION ELEVEN model AE-4022 Urine Analyzer (device component)
AUTION Sticks 10EA Test Strips (reagent component)
Product Description
The AUTION Sticks 10EA consist of a plastic strip containing 10 pads impregnated with chemicals specific
for the determination of a particular analyte. The chemical reaction with the urine results in a color change
and indicates the concentration of the analyte.
The AUTION ELEVEN AE-4022 technology provides fast results that can be used along with other
diagnostic information to rule out certain disease states and to determine if microscopic analysis is needed.
There are substances that may interfere with the chemical reagent on the pads or the urine analyte such
that the result should be double-checked or another means of analysis should be used against the AUTION
ELEVEN AE-4022 results. These interfering substances are further explained on the AUTION Sticks 10EA
package insert.
The AUTION ELEVEN AE-4022 also provides a feature to manually enter the clarity (general transparency
or cloudiness caused by particulates in the specimen), as a useful observance, although it is not measured
by the instrument.

AE-4022 vi
Technology and Scientific Principles
Reflectance spectroscopy is a commonly used means of obtaining the concentration of a particular analyte
in urine analysis. By reading the light reflected, the instrument measures the end product of the chemical
reaction between the urine analyte and the reagent on the pad.
Each of the reagent strip pads reflect a given color and shade when immersed in urine which is indicative
of the analyte concentration. The strip enters the AUTION ELEVEN AE-4022 where it is auto-aligned and
a set of LED’s directs a single wavelength for measurement (635 nm or 565 nm) at each reagent pad on
the test strip. Glucose, protein, pH, specific gravity, and blood determinant pads receive 635 nm and
bilirubin, urobilinogen, ketone, nitrite, and leukocyte pads receive 565 nm. The pad for blood determination
is the exception and does not receive a reference wavelength. The instrument reader detects the
reflectance of the given wavelength off of each individual pad as an indicator of analyte concentration.
To reduce lot-to-lot and device-to-device variability in the instrument and test strips, additional design
features were added. To mitigate variability in the cumulative factors affecting light measured, the infrared
wavelength (760 nm) is also directed at every pad (except blood) to be used as a reference. To mitigate
variability of the color of urine samples (and test strips), there is a reagent-free, additional pad on every strip
also to be used as a reference. Therefore, each analyte has a reflectance off its own pad to compare with
the reflectance of the infrared off its own pad and the reflectance of its wavelength and the infrared
wavelength off of the reference pad. Therefore, where R is reflectance of the particular analyte.
By dividing out the urine color that gave additional reflectance and by multiplying the reciprocal of the infrared
reflectances, variability is mathematically cancelled out and the truest analyte reflectance is determined.
Ranalyte pad
R×R =
reference pad
Rinfrared at reference pad
Rinfrared at analyte pad

AE-4022 vii
Adding the shades light, normal, and dark (based on
wavelengths 430 nm and 760 nm) to each of the colors
(yellow, orange, brown, red, violet, blue and green), 21 color
tones are created. There are 23 color tones altogether
including those categorized as non-reflective ‘Colorless’, and,
if outside the expected range, ‘Other’. This provides the user
a color description and allows for a further refinement of the
reflectance by considering tones.
The following formula is used for Color Tone Correction (C):
Furthermore, in order to eliminate the influence of ambient temperature fluctuation upon measurements,
temperature corrections are applied as follows:
Lastly, the calibration curve algorithm takes a history of device model and technology comparison data into
consideration and converts the reflectance into qualitative symbols and semi-quantitative values for
widespread usability.
The chemical principles, common names of the test strip reagents, and their compositions can be found on
the AUTION Sticks 10EA package insert.
1 COLORLESS
2
LIGHT
YELLOW
3 ORANGE
4BROWN
5RED
6VIOLET
7BLUE
8 GREEN
9
NORMAL
YELLOW
10 ORANGE
11 BROWN
12 RED
13 VIOLET
14 BLUE
15 GREEN
16
DARK
YELLOW
17 ORANGE
18 BROWN
19 RED
20 VIOLET
21 BLUE
22 GREEN
23 OTHER
where a = proprietary constant
( 1 + a – +)
2
/C = R
430
R
760
( 1 + a – +)
2
/R
565
R
760
( 1 + a – )
2
/R
635
R
760
* ( T – 27 ) * R2* ( 1 – R )2 =R R +
withTempCorrection Acorrection coef

AE-4022 viii
Biological Principles*1
Glucose
Glucose concentration in urine can be indicative of (1) a prerenal condition (hyperglycemia), or (2) a renal
condition. Causes for the prerenal condition could include the following: diabetes mellitus, hormonal
disorders (such as hyperthyroidism, acromegaly, stress, anxiety, Cushing’s disease), liver disease,
pancreatic disease, central nervous system damage, or drugs (namely thiazide, diuretics, or steroids).
Causes for the renal condition could include the following: Fanconi’s syndrome, cystinosis, heavy metal
poisoning, genetics, pregnancy.
Protein
An increased amount of protein in the urine, proteinuria, is often the first indicator of renal disease. Early
detection of protein by routine urinalysis screening aids in the identification, treatment, and prevention of
renal disease; however, protein excretion is not an exclusive feature of renal disorders. There are many
causes for renal, glomerular, postural proteinuria, and tabular proteinuria ranging from strenuous exercise
to prescribed drugs, to systemic/infectious diseases such as malaria, lupus or diabetes mellitus.
Bilirubin/Urobilinogen
Disturbances in any aspect of bilirubin formation, hepatic uptake, metabolism, storage, or excretion are
possible in a variety of diseases. Increased production of bilirubin forms can result in hyperbilirubinemia or
bilirubinuria. Healthy individuals excrete very little bilirubin so its detected presence in urine indicates the
disruption or an increase in hemoglobin catabolism. Intestinal bacteria can turn bilirubin into urobilinogen.
It can be an early indicator of liver disease or jaundice. Causes of increased urinary bilirubin and
urobilinogen include: prehapatic (increased heme degradation) due to a transfusion reaction, sickle cell
disease, hereditary spherocytosis, thalassemia, pernicious anemia,
pH
The renal system, pulmonary system, and blood buffers provide the means for maintaining homeostasis at
a pH compatible with life. The kidneys selectively excrete acid or alkali. PH has many applications. An
acidic urine prevents the formation of alkaline renal stones (e.g. calcium carbonate, calcium phosphate) and
inhibits the development of urinary tract infections. An alkaline urine prevents the precipitation of and
enhances the excretion of various drugs (e.g. sulfonamides, streptomycin, and salicylate) and prevents
stone formation from calcium oxalate, uric acid, and cysteine crystals.
The urine pH provides valuable information for assessing and managing disease and determining the
suitability of a specimen for chemical testing. Correlation of the urinary pH with a patient’s condition aids in
the diagnosis of disease (e.g. production of an alkaline urine despite a metabolic acidosis is characteristic
of renal tubular acidosis). Individuals with a history of stone formation can monitor their urinary pH and use
this information to modify their diets if necessary. Highly alkaline urine of pH 8.0 to 9.0 also can interfere
with chemical testing, particularly in protein determination.

AE-4022 ix
Blood
Hematuria is an abnormal amount of red blood cells in the urine, possibly caused by renal and urinary tract
disease, extrarenal disease, trauma, strenuous exercise, or drugs. Hemoglobinuria indicates the presence
of hemoglobins, which may be caused by intravascular hemolysis, extensive burns, strenuous exercise, or
infections. Myoglobinuria is the presence of myoglobin in the blood, possibly caused by skeletal or cardiac
muscle injury, seizures, toxins, metabolic causes, polymyositis and dermatomyositis, or severe exercise.
Ketones
Detection of ketones in the urine can assist in diagnosis of ketonemia and ketonuria which can signify
diabetes mellitus. Ketones in the urine could also result from a loss of carbohydrates available due to
starvation, diet, severe exercise, cold exposure, vomiting, digestive disturbances or defective renal
reabsorption.
Nitrites
Urinary nitrite can be an important tool for identification of urinary tract infections. With early intervention,
the spread of infection to the kidneys and possible development of renal failure can be prevented.
Screening does not replace the urine culture for the identification and quantification of bacteria, but it can
rapidly identify patients with asymptomatic bacteriuria for minimal expense.
Leukocytes (white blood cells)
Significant numbers of white blood cells indicate inflammation in the kidneys or urinary tract. Approximately
0-10 white blood cells per microliter of urine is normal.
Specific Gravity
Specific gravity is a physical property of urine and an expression of concentration. Because solute and
water intake varies, so does the specific gravity of urine. Normal range for urine is 1.002 to 1.035; during
excessive sweating, dehydration, or fluid restriction, urine specific gravity values usually exceed 1.025.
Although 1.010 is a normal specific gravity, patients exhibiting a fixed value of 1.010, regardless of changes
in hydration could have isosthenuria, which implies significant renal tubular dysfunction.
*1: Brunzel, Nancy A. (2004). Fundamentals of Urine & Body Fluid Analysis. Philadelphia, PA: Elsevier.

AE-4022 x
4 For Your Safety and Product Performance
Electrical Compliance
This product conforms to the EMC Standard IEC61326-2-6:2012.
Class of emission: CISPR 11 Class A
For In Vitro Diagnostic Use.
NOTE:
This instrument has been tested and found to comply with the limits for a Class A digital device, pursuant
to part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful
interference when the instrument is operated in a commercial environment. This instrument generates,
uses, and can radiate radio frequency energy and, if not installed and used in accordance with the reference
manual, may cause harmful interference to radio communications.
Operation of this instrument in a residential area is likely to cause harmful interference in which case the
user will be required to correct the interference at his own expense.
The electromagnetic environment should be evaluated prior to operation of the device. Do not use this
device in close proximity to sources of strong electromagnetic radiation, as these may interfere with the
proper operation.
Caution in Handling Specimens
BE CAREFUL WHEN HANDLING URINE. This system uses urine as sample and as an
ingredient of Control. Urine may be contaminated by pathogenic microorganisms that can
cause infectious diseases. Improper handling of urine may cause infection to the user or
other individuals by pathogenic microorganisms.
This instrument is to be operated by qualified persons only. A qualified person is one having
adequate knowledge of clinical testing and the disposal of infectious waste. Thoroughly read
this operating manual before use. Anyone who operates the instrument for the first time
must be assisted by a trained person.
Never touch the test strip tray, carrying arm, or other parts where sample may adhere with
unprotected hands. During cleaning or maintenance of these parts, wear protective gloves
to prevent exposure to pathogenic microorganisms.
Discard used samples, test strips and spare parts in accordance with local regulations for
biohazardous waste.
This instrument may become infectious in the course of use. Discard the instrument in
accordance with local regulations for biohazardous waste.

AE-4022 xi
Symbols
Symbol Meaning
To avoid Personal Injury
Follow the instructions given here to prevent exposure to pathogenic microorganisms.
Follow the instructions given here to prevent injury and property damage.
Follow the instructions given here to prevent pinch points.
Follow the instructions given here to prevent burns from hot surfaces.
To avoid Damage to the Product or its Performance
IMPORTANT: Follow the instructions given here to obtain accurate measurement results.
NOTE: Information useful for preventing damage to the instrument or parts, and other important
information you should keep in mind.
REFERENCE: Additional explanations that help you make the best use of the instrument, and information on
related functions.

AE-4022 xii
Caution Labels
This instrument has several caution labels on the areas that have potential dangers.
Please learn potential dangers warned by each label and observe the precautions described below.
aCarrying arm
bCarrying arm
cMaintenance cover and inside the instrument
c
ab
The carrying arm moves during measurement. While the carrying arm is moving, do not put
your hand close to the arm so as to avoid being caught or pinched.
Never touch with unprotected hands the carrying arm, where the sample may adhere. During
cleaning or maintenance of the carrying arm, wear protective gloves to prevent exposure to
pathogenic microorganisms.
Never touch with unprotected hands the maintenance cover and inside the instrument, where
the sample may adhere. During cleaning or maintenance of these parts, wear protective gloves
to prevent exposure to pathogenic microorganisms.

AE-4022 xiii
dWaste box
eMotor
d
Never touch with unprotected hands the waste box, where the sample may adhere. During
cleaning or maintenance of the waste box, wear protective gloves to prevent exposure to
pathogenic microorganisms.
e
Do not touch the motor and its surrounding area, which may be hot and cause burn on the
hand, especially during operation and just after the instrument is turned off.

AE-4022 xiv
Environmental Conditions
Storage conditions
Temperature: 1 to 30°C, Humidity: 20 to 80% R.H. (non-condensing)
Shipping conditions
Temperature: -10 to 60°C, Humidity: 20 to 80% R.H. (non-condensing)
Operating conditions
Temperature: 10 to 30°C, Humidity: 20 to 80% R.H. (non-condensing)
Measurement conditions
Temperature: 10 to 30°C, Humidity: 30 to 60% R.H. (non-condensing)
Specimen Collection
Specimen collection is as important as the technical performance of urinalysis. Acceptable specimens
improve the quality and reliability of urinalysis results. CLSI Guidelines should be followed. Collection
should be clean and opaque containers should be used to protect the specimen from light. Specimens
should be used within 2 hours or refrigerated. Relevant information should be recorded for the physician
regarding specimen collection, such as time, date, specialized circumstances, whether refrigerated after
collection or not, as well as any medications, strenuous exercise, or presence of menstrual blood that would
influence the results.

AE-4022 xv
Materials Provided
Items in the package
Accessory kit box
No. Name Description Qty.
aInstrument AE-4022 1
bAccessory kit box See below. 1
No. Name Description Qty.
aTest strip tray 1
bCheck strip set 2 check strips (white) 1
cThermal recording paper 58 mm width, 5 rolls 1
dAC adapter 1
ePower cord 1
fOperating manual 1
aInstrument bAccessory kit box
aTest strip tray bCheck strip set cThermal recording paper
dAC adapter ePower cord fOperating manual

AE-4022 xvi
Materials Necessary
AUTION 10EA Sticks (100 sticks per bottle)
Commercial Control solution for use with urine analyzers
Quality Control
Performance of the AUTION ELEVEN AE-4022 and the AUTION Sticks 10EA should be confirmed regularly
utilizing both known negative and known positive urine specimens or control materials. Adhere to all
regulations applicable to the practice region as well as manufacturers’ instructions. Refer to “2.4.3. Control
measurement” on page 2-27 for specific instructions.
Limitations
Please refer to the AUTION Sticks 10EA package insert for information on any limitations and interfering
substances.

AE-4022 1-1
Chapter 1 Before Using the AE-4022
1.1 Outline of the AE-4022.................................................................................. 1-2
1.1.1. AE-4022 Features .............................................................................................1-2
1.1.2. Measurement types...........................................................................................1-4
1.1.3. Specifications ....................................................................................................1-5
1.2 Name and function of each part .................................................................. 1-6
1.2.1. Front side ..........................................................................................................1-6
1.2.2. Rear side ...........................................................................................................1-7
1.2.3. Display...............................................................................................................1-8
1.2.4. Operator panel ................................................................................................1-10
1.3 Installing the instrument ............................................................................ 1-11
1.3.1. Precautions for installation ..............................................................................1-11
1.3.2. Installation of the instrument ...........................................................................1-12
1.3.3. Starting and ending operation after installation ...............................................1-16

Chapter 1 Before Using the AE-4022
AE-4022 1-2
1.1 Outline of the AE-4022
1.1.1 AE-4022 Features
Compact and lightweight, with simple structure
The instrument has a minimal installation footprint of just the area of an A4-size sheet of paper. It can be installed in
various locations and can be carried easily, thanks to its lightweight construction and minimal weight of approx.
3.6 kg. Despite its compactness, the device has sophisticated functions such as a display, built-in printer, section that
removes surplus urine, test strip feed mechanism, mechanism for automatically discarding used test strips, and a
back-up memory that can store the results of up to 520 measurements.
Semi-automatic operation
The user dips test strips into samples and then places them on the test strip tray. The user does not need to pour samples
from collection cups into sample vessels. Small volume samples can also be measured easily.
Dipping timing signal
A buzzer can be set to signal the optimum dipping timing. The user can then dip all test strips for the correct period of
time by paying attention to the buzzer, which keeps the test strip reaction time constant.
Measurement of one sample every seven seconds
The instrument measures one sample every seven seconds at its maximum speed, thus enabling a maximum system
output of 514 samples per hour.
Measurement auto-stop
When the instrument detects that no test strip is placed on the test strip tray, it automatically stops measurement.
Auto start, and non-directional test strip placement
The instrument automatically detects a test strip when placed on the test strip tray and starts measurement.
Measurement can be performed regardless of the test strip orientation (pointing right or left).
Test strip type auto-detection
The instrument automatically identifies the type of test strips (assuming they have auto-classification marks) and
performs the appropriate measurements.
Temperature correction
The optimum ambient temperature range for AUTION ELEVEN measurements using test strips is from 20 to 25°C.
However, even when the ambient temperature is out of this range, at temperatures from 10 to 30°C, the instrument’s
temperature correction function compensates for any deviation caused by temperature. For ambient temperatures
outside the 10 to 30°C range, the instrument may not obtain proper measurement results for certain measurement
items.
Color tone determination
In addition to the measurement of each measurement item, the instrument measures the color tone of samples. The
instrument measures shading and hue, and obtains finely graduated urine color tone data corresponding to 23
categories.
(See “Technology and Scientific Principles” on page vi)

1.1 Outline of the AE-4022
AE-4022 1-3
Abnormal color detection
The instrument has an abnormal color detection function that detects abnormal color generation on the reagent pad.
The instrument prints a “!” mark with the measurement result (only applicable to measurement items KET, BIL, and
URO).
Operator ID function
This function restricts instrument use by requiring operators to enter an ID number to operate the analyzer. This can
lock out persons without an ID number from using the instrument.
Either of the following authorities or both can be assigned to individual operators (or ID numbers) for the restrictions
on setting operations and measurement:
• Access authority to the SETUP menu (user settings)
• Measurement authority to override QC lockout if needed to continue testing and run QC at a later time (when QC
lock-out function is ON).
QC lock-out function
This function locks the instrument from performing measurements when QC has never been performed since the
instrument was installed or the deadline set by the operator has elapsed. The lock is released once control
measurements are performed.
* When the operator ID function is ON, the access authority to the SETUP menu is required to set up the QC lock-out function.
Clarity input function
This function allows the operator to manually input the value of urine clarity obtained visually in order to add it to the
measurement results report. (This instrument does not have a function to automatically determine urine clarity.)
* When the Operator ID function is ON, the access authority to the SETUP menu is required to set up the clarity input function.
Prints measurement results in bold
The instrument prints measurement results with other data emphasizing the results by using bold-type and larger
characters for easy and fast reading.
(See “2.5. How to read the measurement results” on page 2-37)
Easy to maintain
Components that require daily maintenance, such as the carrying arm, test strip tray, and waste box, have simple
structures that can easily be detached and reattached.
Store up to 520 measurement results
The instrument can store up to 520 measurement results. When the number of measurement results exceeds 520, the
instrument automatically deletes the oldest sample data. The measurement results are stored in categories of
measurement types and result types (normal and abnormal).
Optional hand-held barcode reader
A hand-held barcode reader (optional) can be mounted. Each barcode scanned by the barcode reader is allocated a
patient ID number.
Ethernet connection
An Ethernet unit (optional) can be installed.