Limitation of Liability........................................................................................................ 10
300-4410 English Rev C 01/2007 Operators Manual 6
1. Introduction
Introduction
Intended Use
The iChem™100 Urine Chemistry Analyzer is a semi-automated urine
chemistry analyzer intended for use only with iChem™ 10 SG Urine
Chemistry Strips for the in vitro measurement of the following analytes in
urine: glucose, protein, bilirubin, urobilinogen, pH, specific gravity, blood,
ketones, nitrite, leukocytes, ascorbic acid, color and user-defined clarity.
This document is the Operators Manual for the iChem100 Urine Analyzer. It
is intended to explain system operation in detail and to be used as the
basis for training new operators. Retain this manual for future use. It is
an information guide and a troubleshooting reference. It explains
program settings and gives maintenance instructions.
How to use the Operator’s Manual
This manual contains important information on the functions of the
iChem100 distributed by Iris Diagnostics. This manual contains
instructions for the operation, maintenance and troubleshooting of the
iChem100.
Before operating the iChem100, read this manual carefully.
300-4410 English Rev C 01/2007 Operators Manual 7
1. Introduction
Precautions and Warnings
The Operators Manual includes information and warnings that must be
observed by the operator in order to ensure safe operation of the system.
Important messages are highlighted with borders and special icons
identifying the type of message enclosed.
There are four types of messages: Notes, Cautions, Warnings and
Biological Warnings.
Notes
NOTE: Highlights important facts, gives helpful information and tips and clarifies procedures.
Cautions
CAUTION: Electrical caution! Unplug before handling.
CAUTION: Important information on the proper operation of the
iChem100 Urine Analyzer. This information is crucial in preventing
instrument damage and maintaining the analyzer.
CAUTION: Laser light caution. A laser is used to read the barcodes.
Protect eyes from the laser light.
Warnings
WARNING: Identifies potentially hazardous situations that could result in
serious injury to laboratory personnel.
Biological Warnings
WARNING: Use care when handling urine samples or used test strips.
Always wear gloves to prevent exposure to pathogens. Incorrect or
imprecise procedures may result in exposure to pathogens. This unit
must only be used by operators trained in proper procedures for clinical
testing and handling of biohazardous waste.
Warnings, Precautions, Limitations
Do not place the iChem100 in water.
Do not drop or throw the instrument.
300-4410 English Rev C 01/2007 Operators Manual 8
1. Introduction
Operate the instrument on a dry, level surface.
Do not move the instrument while a test is in process.
Plug the instrument into a grounded power source.
Avoid sources of bright light/heat.
Iris Diagnostics Contact Information
Customer opinion and input is extremely important to us. Iris Diagnostics
wants to design products that meet your needs. Comments on this
manual should be directed to:
Iris Diagnostics
Attention: Clinical Support
9172 Eton Avenue
Chatsworth, CA 91311
USA
Telephone
From U.S. and Canada locations +1-800-PRO-IRIS (776-4747)
From outside the U.S. +1-818-709-1244
Fax +1-818-700-9661
E-mail clinsupport@proiris.com
Warranty
Iris Diagnostics, a Division of IRIS International, Inc. (Iris) warrants that
the products manufactured by it or its affiliates and sold hereunder shall
be free from defects in material and/or workmanship, under normal use
and service, for the period expiring twelve (12) months from the
completion of installation, or upon Purchaser’s signature on Iris
Diagnostics Warranty/ Acceptance form, or fifteen (15) months from
shipment, whichever occurs first. No warranty extended by Iris
Diagnostics shall apply to any products which have been modified,
(including any third party software), altered, or repaired by persons other
than those authorized or approved by Iris Diagnostics or to products sold
as “used.”
Iris Diagnostics’ obligation under this warranty is limited SOLELY to the
repair or replacement, at Iris Diagnostics’ option, of defective parts,
F.O.B. warehouse or local Iris Diagnostics office, or as otherwise
300-4410 English Rev C 01/2007 Operators Manual 9
1. Introduction
specified by Iris Diagnostics. Repairs or replacement deliveries shall not
interrupt or prolong the term of this warranty. Iris Diagnostics’ warranty
does not apply to consumable materials, except as specially stated in
writing, nor to products or parts thereof manufactured by the Purchaser.
This limited warranty is made on condition that immediate written notice
of any defect be given to Iris Diagnostics and that Iris Diagnostics
inspection reveals that the Purchaser’s claim is valid under the terms of
this warranty.
I
RIS DIAGNOSTICS MAKES NO WARRANTY OTHER THAN THE ONE SET FORTH
HEREIN OR THAT WHICH MAY BE PROVIDED IN A SEPARATE WARRANTY
COVERING THE APPLICABLE PRODUCT CATEGORY
IS IN LIEU OF ALL OTHER WARRANTIES
BUT NOT LIMITED TO ANY EXPRESSED OR IMPLIED WARRANTY OF
MERCHANTABILITY OR FITNESS FOR PARTICULAR PURPOSES AND SUCH
CONSTITUTES THE ONLY WARRANTY MADE WITH RESPECT TO THE PRODUCTS
. SUCH LIMITED WARRANTY
, EXPRESSED OR IMPLIED, INCLUDING
.
Limitation of Liability
Iris Diagnostics shall not be liable for any loss of use, revenue or
anticipated profits, or for any consequential or incidental damages
resulting from the sale or use of the products.
300-4410 English Rev C 01/2007 Operators Manual 10
2. System Description
2
System Description
Theory of Operation ........................................................................................................ 12
Features ......................................................................................................................12
Test Strips ...................................................................................................................12
Consumables or Part Replacement ................................................................................ 22
300-4410 English Rev C 01/2007 Operators Manual 11
2. System Description
Theory of Operation
The iChem100 is a semi-automated urine chemistry analyzer performing
measurements of urine chemical constituents utilizing test strips. The
iChem100 is a reflectance densitometer.
Features
The iChem100:
• reads and interprets without operator variability
• processes and analyzes urine strips with a throughput of 210
samples per hour
•enables entry of microscopic results
Test Strips
•enables automated urine color determination with up to twelve
programmed choices
• reads ascorbic acid for interference detection
• allows users to correct or compensate for urine discoloration
• allows batch and stat mode for sample processing
The test strips have reagent-impregnated specialty paper pads to perform
c
hemical analysis of:
• bilirubin
• urobilinoge
n
• ketones
• ascorbic acid
• glucose
• protein
• blood
• pH
• nitrite
• leukocytes
• specific gravity
The advantage of this approach is ease of testing. The process requires
that an operator dip the urine test strip with its reagent-impregnated pads
into and out of a urine sample. This action brings the reagentimpregnated pads into contact with the urine containing the analytes to be
300-4410 English Rev C 01/2007 Operators Manual 12
2. System Description
Optics
tested. Once the test strip has been dipped into the urine, color deve
on each of the reagent-impregnated pads in direct proportion to th
amount of analyte present in the sample. The test strips have a
compensation pad to determine the color of the urine as
fo
r color interference on the impregnated reagent pads.
After the test strips are placed on the Test Strip Tray with correct
orientation, they are automatically transported to the measurement
window and the r
the iChem100.
emainder of the operation is performed automatically by
well as correct
e
lops
LED Unit
For the illumination of the measurement, a LED Unit with three differen
wavelengths LEDs (450nm, 530nm and 625nm) is used. To increase
homogeneity, the LED’s are not placed regularly over the measurement
window but are placed mainly towards the outer area of the LED Unit.
order to achieve a very high light intensity, one reflector and one antireflector are placed beside the LED
e
ntire urine test strip is illuminated.
LED Unit Inside View Side View
300-4410 English Rev C 01/2007 Operators Manual 13
line. With this optical design, the
t
In
2. System Description
CMOS Image Sensor
Unlike most of the reflectometers in the market for urine test strip
analysis, the iChem100 does not use a photodiode detector to measure
the reflected light, but instead utilizes a CMOS (Complementary Metal
Oxide Semiconductor) image sensor that captures a color image of each
of the test pads. The CMOS image sensor is able to photograph almost
the whole length (100mm) of the urine test strip and all of its width. As
seen in the figure above, the CMOS image sensor has been placed
perpendicular to the measurement level, and since the height of the
instrument limits the optical length, a mirror has been used for changing
the direction of the beam.
Optics Calibration
Prior to each measurement, the optics assembly is calibrated using a
“fixed standard” and it permits a one-point calibration. The iChem100 is
also capable of performing an internal, automated two-point calibration if
the one-point calibration done before each specimen determination falls
outside of the acceptable limits. A secondary “movable standard” is
automatically moved into place and readings from it in conjunction with
the “fixed standard” are used to perform a two-point calibration. No
external calibration strips or procedures are required.
Measurement
Once calibrated, the urine test strip is sequentially illuminated by the
LEDs (Red, Blue, Green) that are located at a 30
impregnated reagent pads, and the reflected signals are sent via the
mirror through the lens and captured by the CMOS camera. The captured
signal is evaluated and a completed result is provided for each of the
chemistries.
The iChem100 uses a compensation pad to determine the color of the
urine as well as correct for color interference on the impregnated reagent
pads. Since the iChem100 is capturing a pixelized image of the blood
pad, a special algorithm has been developed using more than a
reflectance to differentiate between intact and hemolyzed red blood cells.
º angle to the
300-4410 English Rev C 01/2007 Operators Manual 14
2. System Description
Instrument Components
Front
Back
3
6
4
5
2
7
1
1 - Keyboard
2 - Transport mechanism enclosure
3 - Display screen
4 - Paper roll
5 - Transport belt opening (for placement of strip)
6 - Clarity and specimen type barcode labels
7 - Hand-held barcode reader
300-4410 English Rev C 01/2007 Operators Manual 15
2. System Description
Most user inputs are designed to be via the keyboard or the barcode
reader.
The keyboard is used for navigating within a screen, between screens,
making selections and entering data inputs.
The barcode reader enables you to enter information via barcoded data
into selected entry fields, (e.g., patient identification, specimen
identification, color, clarity, etc.).
300-4410 English Rev C 01/2007 Operators Manual 16
2. System Description
Software
Data Entry Fields
Data entry fields are areas in a screen where information is entered. One
screen can have several data entry fields, but only one field can be
selected and active for entering data at a time. Pressing an alpha or a
numeric key will input that character into the data entry field. If you
exceed the number of allowable characters in a field, you cannot enter
more characters until some characters have been deleted.
To select a data entry field, use the keyboard [↑] or [↓] keys to move the
cursor up or down in the screen. To move back and forth between left
and right columns, use the [Tab] key. The contents of the field will be
reverse highlighted to show that they are selected or active.
To delete contents from a data field, select the field using the keyboard’s
[↑] or [↓] or [Tab] keys, then press the [Delete] key.
To erase contents from data field one character at a time, select the field
using the keyboard’s [↑] or [↓] or [Tab] keys, then press the [Backspace]
key. The last character in the field will be deleted.
Toggle Fields
Toggle fields are fields setup in a circular fashion allowing you to choose
one field out of a series of pre-setup fields (e.g., blank, trace, few,
moderate, many, etc.). A toggle field will be indicated by a doubleheaded arrow [↔]. Only one toggle field can be active at a given time.
To select a toggle field, use the keyboard keys [↑] or [↓] to move the
cursor into the desired field.
To view the choices in a toggle field, use the keyboard keys [←] or [→] to
advance through the selections. To switch back and forth from a left
toggle field to a right toggle field, press the [Tab] key.
To confirm or lock in a selection, you may press the [Enter] key or use
the keys [↑] or [↓]. Either one will lock in the selection and advance you
to the next field.
300-4410 English Rev C 01/2007 Operators Manual 17
2. System Description
Function Keys
Pressing a function key, [F1] through [F10], will allow you to access the
described function associated with it. For example, to choose to run a
patient sample, press [F2] while the Main Menu screen is displayed. The
function keys will only perform the function that is associated with it in the
currently displayed screen.
Menu Diagram
Main Menu
03/10/2006 1:50PM
F1 WORKLIST F5 SETUP
MAIN MENU
F2 RUN PATIENT F6 MICROSCOPIC
F3 RESULTS F7 SERVICE
F4 CONTROLS
Worklist Menu
WORKLIST MENU
F1 CREATE
F2 DOWNLOAD
F3 VIEW/EDIT
F4 RUN
F5 PRINT
300-4410 English Rev C 01/2007 Operators Manual 18
2. System Description
Run Patient Menu
Enter information, then place urine
strip on transport belt.
SEQ 003
SPEC/PAT ID
LAST NAME
FIRST NAME
CLARITY ↔
SPC TYPE ↔
300-4410 English Rev C 01/2007 Operators Manual 23
3. Set Up
Setting the Language
This screen allows you to select the desired language with which to
display screens. The instrument can be set to one of six different
languages:
English Deutsch
Français Italiano
Español Português
1. From the Main Menu, press the [F7] key to access the Service Menu.
2. From the Service Menu, press the [F3] key. The Language Setup
screen will be displayed.
3. Use the [←] or [→] arrow keys to toggle through the six language
options.
4. Press the [F1] key to lock in your selection and return to the Service Menu screen, or press the [F2] key to lock in your selection and
return to the Main Menu screen.
300-4410 English Rev C 01/2007 Operators Manual 24
3. Set Up
Setting Date and Time
This screen allows you to enter the correct date and time and select the
format for the instrument displays and printouts.
1. From the Main Menu, press the [F7] key. The Service Menu screen
will be displayed.
F1 DATE/TIME F4 DIAGNOSTICS
F2 PRINTER F5 TRANSMIT
F3 LANGUAGE F6 TEST STRIP
SERVICE MENU
F7 MAIN MENU
2. Press the [F1] key to display the Set Date/Time screen.
SET DATE / TIME
DATE FORMAT mm/dd/yyyy
TIME FORMAT am / pm
DATE 03/23/2006
TIME 10:00 pm ↔
F1 FORMAT F2 SERVICE F3 MAIN MENU
300-4410 English Rev C 01/2007 Operators Manual 25
3. Set Up
Setting the Date or Time Format
1. From the Set Date/Time screen, press the [F1] key to display the
Format Date/Time screen.
2. Use the [←] or [→] arrow keys to toggle through three date options:
• dd.mm.yyyy
• mm/dd/yyyy
• yyyy/mm/dd
3. Press the [↑] or [↓] arrow keys, or the [Enter] key to lock in your
selection and move to the next field.
4. Use the [←] or [→] arrow keys to toggle through the two time options:
• 24 hour
• am/pm
5. Press the [F1] key to return to the Date/Time screen.
Changing the Date and Time
1. From the Date/Time screen, use the [↑] or [↓] arrow keys or the
[Enter] key to move to the desired field (e.g., DATE, TIME or am/pm).
2. To enter or change the date, select the DATE field, and then enter the
correct date using the keyboard numeric keys.
NOTE: You must enter two digits for the month and the day (e.g., 01
for January, etc.)
300-4410 English Rev C 01/2007 Operators Manual 26
3. Set Up
3. To enter or change the time, select the TIME field, and then enter the
correct time using the keyboard numeric keys.
NOTE: You must enter two digits for the hour and the minutes (e.g.,
01:01 for 1:01, etc.).
4. To change the am/pm selection (if desired), select the am/pm field,
use the [←] or [→] arrow keys to select am or pm.
5. Press the [F2] key to return to the Service Menu screen, or press the [F3] key to return to the Main Menu screen.
300-4410 English Rev C 01/2007 Operators Manual 27
3. Set Up
Setting the Reporting Units
This screen allows you to select the reporting units for the results of the
test strips chemistries. You may select from the following options:
• Conventional (mg/dL)
• S.I. (Standard International—µmol/L and mmol/L)
• Qualitative (+)
• Customized (a combination of all three)
1. From the Main Menu, press the [F5] key. The Setup Menu will be
displayed.
2. From the Setup Menu, press the [F1] key. The Units screen will be
displayed.
3. To select either conventional, S.I., or qualitative units exclusively,
select the desired unit option using the [↑] or [↓] arrow keys, then
press the [F1] function key.
300-4410 English Rev C 01/2007 Operators Manual 28
3. Set Up
Conventional (mg/dL) Units
Standard International (µmol/ L) units
Qualitative (+) units
Press the [F1] key to return to the Units screen from any of these display
screens.
300-4410 English Rev C 01/2007 Operators Manual 29
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