OPERATORS MANU
AL
UA
ChemWell Models 2902 and 2910
TABLE OF CONTENTS
1. INTRODUCTION .................................................................................................................................... 1
1.1 INTENDED USE ...................................................................................................................................... 2
1.2 WARNING MARKINGS............................................................................................................................ 2
1.2.1 Safety Symbols ............................................................................................................................... 2
1.2.2 Safety Terms .................................................................................................................................. 3
1.3 SAFETY PRECAUTIONS........................................................................................................................... 3
1.4 OPERATING PRECAUTIONS .................................................................................................................... 5
2. INSTALLATION .................................................................................................................................... 7
2.1 UNPACKING THE INSTRUMENT .............................................................................................................. 7
2.2 INSTRUMENT UNPACK CHECKLIST ...................................................................................................... 11
2.3 INSTRUMENT SETUP ............................................................................................................................ 13
2.4 INSTRUMENT CHECK OUT ................................................................................................................... 18
3. PRINCIPLES AND SPECIFICATIONS ............................................................................................. 19
3.1 CONTINUOUS LOADING ....................................................................................................................... 19
3.2 TECHNICAL SPECIFICATIONS ............................................................................................................... 20
4. CHEMWELL MANAGER.................................................................................................................... 23
4.1 OPENING THE SOFTWARE AND SECURITY ............................................................................................ 23
4.1.1 Opening the ChemWell Program................................................................................................. 23
4.1.2 Password Security and Logging In.............................................................................................. 23
4.1.3 Security Menu Options ................................................................................................................ 24
4.2 UTILITY MENU/ALIGNMENT SETUP ..................................................................................................... 25
4.2.1 Alignment..................................................................................................................................... 25
4.2.2 Rack2 Dispense Height................................................................................................................ 31
4.2.3 Display Instrument Parameters................................................................................................... 32
4.2.4 Restore Instrument Parameters ................................................................................................... 32
4.2.5 Channel Blank ............................................................................................................................. 33
4.2.6 Self Test ....................................................................................................................................... 35
4.2.7 Filter Voltages ............................................................................................................................. 37
4.2.8 Launch Assay Editor.................................................................................................................... 38
4.2.9 Launch Pack ................................................................................................................................ 39
4.2.10 Launch Report Creator.............................................................................................................. 41
4.2.11 ChemWell Manager Toolbar Icons............................................................................................ 42
4.3 CHEMWELL MANAGER TABS .............................................................................................................. 43
4.3.1 Layout Tab................................................................................................................................... 43
4.3.2 Calibration Tab ........................................................................................................................... 45
4.3.3 Sample Tab .................................................................................................................................. 48
4.3.4 Test List Tab ................................................................................................................................ 50
4.3.5 Report Tab ................................................................................................................................... 52
4.4 MAIN MENU SELECTIONS AND FEATURES ........................................................................................... 55
4.4.1 Management Menu ...................................................................................................................... 55
4.4.1.1 Laboratory Information System (LIS)....................................................................................... 56
4.4.2 Routines Menu ............................................................................................................................. 59
4.4.3 Lot # Registration ........................................................................................................................ 60
4.4.4 QC Tracking ................................................................................................................................ 60
4.4.5 Sample DB ................................................................................................................................... 62
4.4.6 Settings ........................................................................................................................................ 62
4.4.7 Security ........................................................................................................................................ 62
4.4.8 Help ............................................................................................................................................. 62
4.4.8.1 About ........................................................................................................................................ 62
5. RUNNING CHEMWELL..................................................................................................................... 63
5.1 GENERAL SETTINGS ............................................................................................................................ 63
5.1.1 Auto Wash.................................................................................................................................... 63
5.1.2 Software Settings ......................................................................................................................... 64
5.1.2.1 Sample Database ...................................................................................................................... 65
5.1.2.2 Chemistry Washing................................................................................................................... 66
5.1.2.3 Chemistry Strategy ................................................................................................................... 67
5.1.2.4 EIA Strategy.............................................................................................................................. 68
5.1.2.5 Report Appearance ................................................................................................................... 69
5.1.2.6 Report Output ........................................................................................................................... 70
5.1.3 Custom Report Settings ............................................................................................................... 71
5.2 START OF DAY .................................................................................................................................... 73
5.2.1 Run Start of Day .......................................................................................................................... 73
5.2.1.1 Weekly Alcohol Cleaning.......................................................................................................... 74
5.2.2 Sample Database Setup ............................................................................................................... 75
5.2.2.1 Add Sample ID.......................................................................................................................... 75
5.2.2.2 Modify Sample ID..................................................................................................................... 77
5.2.2.3 Delete Sample ID...................................................................................................................... 77
5.2.2.4 View Log................................................................................................................................... 78
5.2.2.5 Import Patient Record .............................................................................................................. 78
5.2.2.6 Export Patient Record .............................................................................................................. 79
5.2.2.7 Search Patient Record .............................................................................................................. 80
5.2.2.8 Choose Patient Record ............................................................................................................. 81
5.2.3 Calibrators .................................................................................................................................. 82
5.3 RUNNING SAMPLES ............................................................................................................................. 87
5.4 END OF DAY ........................................................................................................................................ 90
6. ASSAY EDITOR .................................................................................................................................... 91
6.1 MAIN MENU AND TOOLBAR ................................................................................................................ 93
6.1.1 Assay............................................................................................................................................ 93
6.1.2 View ............................................................................................................................................. 93
6.1.3 Substances ................................................................................................................................... 94
6.1.4 Panels .......................................................................................................................................... 95
6.1.5 Indices ......................................................................................................................................... 96
6.1.6 Security ........................................................................................................................................ 98
6.1.7 Settings ...................................................................................................................................... 100
6.1.8 Assay Editor Help Menu............................................................................................................ 101
6.1.9 Icons .......................................................................................................................................... 102
6.2 CREATING CHEMISTRY/EIA ASSAYS................................................................................................. 103
6.3 ASSAY STEPS ..................................................................................................................................... 108
6.3.1 Select Step.................................................................................................................................. 108
6.3.1.1 Add Sample............................................................................................................................. 109
6.3.1.2 Add Reagent............................................................................................................................ 112
6.3.1.3 Incubate (Lag Time) ............................................................................................................... 115
6.3.1.4 Read........................................................................................................................................ 116
6.3.1.5 Clean Probe............................................................................................................................ 120
6.3.1.6 Rinse Probe ............................................................................................................................ 120
6.3.2 Edit Step..................................................................................................................................... 121
6.3.3 Order Steps................................................................................................................................ 121
6.3.4 Delete Step................................................................................................................................. 122
6.3.5 Copy Step................................................................................................................................... 122
6.4 INTERPRETATION SETTINGS............................................................................................................... 123
6.5 SPECIAL GROUPS ASSAY EDITOR ...................................................................................................... 125
6.6 STANDARDS....................................................................................................................................... 128
6.7 BLANK............................................................................................................................................... 131
1. INTRODUCTION
ChemWell is a computer controlled instrument system, capable of automating any or all
stages of assay processing that involve these functions:
The system allows one to define and program an unlimited number of customized
protocols by selecting displayed menu options from a Microsoft Windows software
program (see Operating Precautions, Section 1.4).
This open system can be programmed to perform any of the colorimetric biochemistry
assays that can be handled using the volumes, temperatures, and wavelengths provided.
It has many possible applications in clinical and veterinary testing; environmental testing;
analysis of food and water; and life science research.
ChemWell may also be used in production processes involving micro volume
dispensing, diluting, incubating, and reading.
ChemWell is a unique automatic biochemistry system. Reactions occur in standard
plastic microwells instead of sample cups or a carousel. Microwell strips are
commercially available from many sources. Reagent bottles and sample tubes are
placed into the removable instrument racks. The instrument is programmed to pick up
from one place, dispense to another, wash the probe, read the wells, incubate, mix, etc.
When doing chemistry reactions, groups of four wells may be timed simultaneously to
improve throughput.
ChemWell is not dedicated for use with any particular chemical reaction, method, or
manufacturer. This provides many advantages, including great flexibility in how it is
used. Each lab decides how to set up the racks and plates, which reagents to use, how
many controls to run, number of applications to be used, and so on. This also means
that the Assay Editor must first be programmed before each new application.
To assure the quality of clinical information, each new setup must be validated before
reporting specimen results. In some cases the programming, optimization, and validation
may have already been done.
Example assays are provided for many of the commonly performed bio-chemistries.
Before applying any new clinical reagent system, first check with the diagnostic reagent
manufacturer for specific instructions, validation information, and application tips.
ChemWell
It is also advised to run specimens having known concentrations to verify the instrument
setup parameters. After that, programs can easily be recalled for review, use, change, or
deletion. The user can decide everything, including how much is manual and how much
is automatic.
ChemWell instruments and software are tools developed for the modern global
laboratory. The power and freedom to apply ChemWell is completely yours!
WARNING
Protective Ground
CAUTION
BIOHAZARD
Risk of Shock
(Earth) Terminal
Refer To Manual
Risk of Infection
FUSE: For continued protection against risk of fire, replace with fuse only with
one of the specified type and current ratings. Disconnect equipment from supply
before replacing fuse.
ChemWell
WARNING
CAUTION
CAUTION
Read Instructions Please take the time to read this manual carefully before using
this instrument. Review the following safety precautions to avoid injury and prevent
damage to this instrument or any products connected to it. To avoid potential
hazards, use this instrument only as specified. For best results, familiarize yourself
with the instrument and its capabilities before attempting any clinical diagnostic
tests. Refer any questions to your instrument service provider.
ChemWell
Use Proper Power Cord Use only the power cord specified for this product and
certified for the country of use.
Ground the Product This product is grounded through the grounding conductor of
the power cord. To avoid electric shock, the grounding conductor must be
connected to earth ground. An optional method is to attach a ground strap from the
external grounding terminal on the rear panel of the instrument to a suitable ground
such as a grounded pipe or some metal surface to earth ground.
Warning!
Warning! To avoid electric shock, the grounding conductor
must be connected to earth ground. To avoid electric shock,
the grounding conductor must be connected to earth ground.
An optional method is to attach a ground strap from the
external grounding terminal on the rear panel of the
instrument to a suitable ground such as a grounded pipe or
some metal surface to earth ground.
Observe All Terminal Ratings To avoid fire or shock hazard, observe all ratings
and markings on the instrument. Consult this manual for further ratings information
before making connections to the instrument.
Do Not Operate Without Probe Shield Do not operate this instrument with shield
removed. Doing so risks the operator to biohazard injury from the probe.
Use Proper Fuse Use only the fuse type and rating specified by the manufacturer
for this instrument.
ChemWell
Do Not Operate With Suspected Failures If you suspect there is damage to this
instrument, have it inspected by a qualified service person.
Keep Instrument Surfaces Clean and Dry Solvents such as acetone or thinner
will damage the instrument. Do not use solvents to clean the unit. Avoid abrasive
cleaners; the aerosol shield is liquid-resistant, but easily scratched. Clean the
exterior of the instrument with a soft cloth using plain water. If needed, a mild allpurpose or nonabrasive cleaner may be used. Use as a disinfectant a 10% solution
of chlorine bleach (5.25% Sodium Hypochlorite) or 70% isopropyl alcohol. Take
special care not to spill liquid inside the instrument.
Watch the instrument during "Start of Day" operation to ensure that the probe and
wash head dispense functions are operating properly.
Be sure to run a sufficient number of controls in each assay. If controls are not
within their acceptable limits; or if incomplete, or non-uniform washing is suspected,
disregard test results.
Since the ambient light may interfere with the optical sensors used to monitor
mechanical movements, always operate the instrument with the top cover down.
Do not operate the instrument if the probe is damaged or the pressure is unstable.
NOTE: The following Operating Precautions are for models with microplate washing only.
Do not operate the instrument if the wash head probes are damaged.
If the Waste bottle is overturned during operation, set it upright. When the run has
finished, check that the filter has not become wet, and replace it if necessary. If the
hydrophobic filter becomes wet due to an overturned Waste bottle, it will be blocked.
Continued use of the instrument with a blocked filter will impair washer
effectiveness and may result in damage to the instrument.
Do not fill reagent bottles past the neck. Doing so may cause the system to
inadvertently aspirate air.
ChemWell
Do not fill Wash or Rinse bottles into the neck to prevent fluid from entering the
pressure tube.
The Wash and Rinse bottles are pressurized during normal operation, and the
Waste bottle is under vacuum.
o
Do not remove bottle caps or tubing connections while the bottles are
pressurized.
Turn the instrument off or click the Pause Engine in the Management menu
before adding more solution, changing bottles, or connecting tubing.
The quality of washing often affects the validity of test results. To assure adequate
washing follow these precautions:
o
Perform End of Day to clean probe with bleach and flush wash head with
H2O
CAUTION!
CAUTION! To avoid waste fluid from backing up into the
instrument, ensure that the drain tube is positioned such that
the flow of gravity allows waste fluid to drain directly into the
waste container. The end of the drain tube should not rest in
the waste fluid nor should it rest against the bottom of the
waste container.
ChemWell
2. INSTALLATION
How to unpack, set up, and check out your ChemWell
ChemWell is carefully packaged in a custom-made container to assure its safe arrival.
If upon receipt the outer packaging is damaged report damage to your freight carrier
immediately.
When shipping, it is important that the instrument be anchored and packaged in the
original manner to prevent shipping damage. Therefore, retain all shipping screws
and packaging in the event the instrument requires future relocation. The following
section details how to unpack the instrument once it is removed from its crate.
Note: Please check the shipping documents for instructions to remove the
instrument from the packing crate.
Cut the
twine at the
foot of the
instrument
ChemWell
Pull the
tag in the
direction
of the
arrow
shown in
Figure 1B
Figure 2.1-A
Figure 2.1-B
6. Remove the two (2) screws holding the interior plate cover. Slide it out through the
front of the instrument and set aside. Refer to Figure 2.1-2.
7. Cut the wire ties securing the packing splints and remove them from the front right
and left rear of the plate-mover shaking platform. Refer to Figure 2.1-3 (highlighted
in gray).
Remove
Cut and remove wire
tie, then remove white
plastic splint.
Figure 2.1-3 Location of wire ties, packing splints and shipping bracket
8. Remove shipping bracket from the front of the plate mover undercarriage. Refer to
Figure 2.1-3 (highlighted in white).
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9. Cut and remove the tie wraps that secure the Probe Z for shipment (Figure 2.1-4).
Cut and
remove the tie
wraps that
secure the
Probe Z for
shipment.
Figure 2.1-4
10. Unscrew the blue probe tip support from the unit (Figure 2.1-5). Locate the Probe Tip
included in the shipping bag. Remove the protective tubing from the end of the tip.
Unscrew ferrule. (Refer to Figure 2.1-6)
11. Ensure small orange O-Ring remains intact; assemble Probe Tip as shown in
Figure 2.1-6.
12. Twist on Probe Tip Assembly finger tight, as shown in Figures 2.1-7 and 2.1-8.
ChemWell
Note: Disregard the following step as shown in Figure 2.1-9 if your instrument
does not have a washer:
13. Remove the green packaging material (two (2) valve tubing supports) from the Rinse
and Wash Dispense Valves. Pull them out toward the front of the instrument.
WARNING: If the Valve Blocks are not removed the Photometer will flood with
fluids when a Wash or Rinse command is issued.
10
ChemWell
Quantity
Description
Certificate of Conformity
Certificate of Quality
Power cord
Serial cable
Drain tube
Sample rack
Reagent rack
50
12
12
ChemWell
11
12
Quantity
Description
Acrylic white foam tape, 3", P/N: 150206 (If washer is included)
10
Cable ties
#2 Nuts
#4 Nuts
#4 Flat Washers
#6 Washers
#6 Nuts
Window Sticker
ChemWell
CAUTION: Do not allow the end of the tubing to rest in the drain container
below the expected level of the waste liquid.
NOTE: Disregard Steps 3 and 4; and Figure 2.3-1 Connectors, if your ChemWell
does not have a washer.
3. Match the color-coded connectors on the three bottle cap assemblies to the colored
connectors on the right side of the instrument. Turn each connector about 1/4 turn
clockwise to lock it in place. Insert the sensor cable jacks, matching the colored tie
wrap with the color-coded connectors.
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4. Put de-ionized (DiH20) water into the bottle marked Rinse. Put wash buffer provided
by the EIA manufacturer into the bottle marked Wash for EIA tests or 0.01% Tween20 for chemistries. A starter kit of Chemistry Wash Concentrate is included with your
instrument. Leave the Waste bottle empty. Check that each bottle cap is securely
fastened and that no sensor wires are crossed. Note that the Waste bottle has short
sensor leads in order to detect when waste is nearly full. Rinse and Wash bottles
have long leads in order to sense when bottles are nearly empty.
5. Fill the Prime bottle with fresh, clean de-Ionized H2O. This should be done each
day - this water enters the precision calibrated syringe pumps and therefore must be
very pure to avoid damage and prolong the life of these components. Prime bottle
installed as shown in Figure 2.3-2.
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ChemWell
6. Using the serial cable provided, connect the computers serial port to the ChemWell
serial port (reference Figure 2.3-3 Back of Instrument). If necessary, purchase a
USB to serial converter, available through other sources.
Power
Switch
External Protective
Grounding Terminal
Power Cord
Connection
Reset
Button
Serial Port
Version 6.3
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8. Connect the power cord to the instrument, then to an approved power source. It is
strongly advised that a UPS (Uninterruptible Power Supply) be used to avoid power
interruptions to the ChemWell and to the computer.
Warning!
Warning! To avoid electric shock, the grounding conductor
must be connected to earth ground. To avoid electric shock,
the grounding conductor must be connected to earth ground.
An optional method is to attach a ground strap from the
external grounding terminal on the rear panel of the
instrument to a suitable ground such as a grounded pipe or
some metal surface to earth ground.
9. Place a rack onto each of the two rack holders. The default positioning places the
Reagent rack on the left and the Sample rack on the right. Place the incubator plate
loaded with microwells into the plate carrier at the right.
NOTE: When starting the software for the first time a ChemWell software
prompt will ask if there is a washer. If there is no plate washer, reply No
and confirm your response.
10. The program default is to use COM1 for communication with the instrument. If
connecting the instrument to a different port, go to the Settings Menu and select
Software. Select a communications port and click OK.
The default temperature is 37C in Chemistry Mode and Room Temperature in EIA
Mode. These are the most commonly used temperatures.
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The probe moves to its home position (to the left), over the plate, and then to the
wash cup
These events are controlled by firmware installed in your instrument; however, the
software must be running for proper operation.
If the instruments power comes on, but these actions do not occur and the beep sound
continues, there is a problem with the communications setup. Check the serial cable
connections and COM port settings.
For the Instrument with Washer:
At this time, the wash arm is raised from its shipping position. Install the wash head
(found in the accessories carton) to the wash arm using the two attached thumbscrews.
The luer fittings must face outward (toward the user), and the color-coded fittings on the
tubing should be fastened finger-tight to the wash head. Refer to Figure 2.4-1 Wash
Head Installation.
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Maximum throughput
Typical reaction
Dimensions
Pumps:
Probe:
2l 1.95ml
Typically 27 or 44
o Assorted replaceable racks and custom
designed racks are available for various
bottle sizes.
o Reagents can also be programmed to go
to the Sample rack.
Reaction vessel:
Instrument bottles:
1L Priming bottle
NOTE: If microplate washer is present included are: a) 2L Wash bottle w/ low volume
warning sensor; b) 1L Rinse bottle (or 2nd wash) w/ low volume warning sensor; and c) 2L
Waste bottle w/ full warning sensor.
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ChemWell
Thermal control:
Programs:
Reading:
Optical design:
Light Source:
Tungsten-Xenon lamp
Interference filters:
Linear range:
-0.2 to 3.0A
Photometric Accuracy:
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Software:
Format:
Operating Systems:
Minimum System:
Recommended system:
Secondary menu options:
Calculation modes:
Power:
Voltage Range:
Frequency Range:
Power Maximum:
Installation Category:
NOTE: Although it may be safe to operate in these conditions, it may not be suitable for
the performance of your tests. Check with your reagent supplier.
18-35C recommended
Less than 85% recommended
Certifications:
22
ChemWell
4. CHEMWELL MANAGER
4.1 Opening the Software and Security
ChemWell uses the standard Windows controls, windows, and dialogs. Refer to your
Windows documentation to become familiar with these controls and how to use them.
NOTE: It is not necessary to turn the instrument off when restarting the software.
There are three security access levels: Administrator, Manager and Operator. View
Figure 4.1.2-1 for security levels.
Security Level
Disable Security
Enable Security
Create Manager
Create Operator
Remove Manager
Remove Operator
Change Password
View Log File
ChemWell
Administrator
Manager
Y
N
Y
N
Y
N
Y
Y
Y
N
Y
Y
Y
Y
Y
N
Figure 4.1.2-1 Security Levels
Operator
N
N
N
N
N
N
Y
N
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Login as Different User displays the Login screen and allows you to login with a
different name and password.
Create New User creates a new user with ID, password, and security level. The
manager can create users, but will only be able to give them operator level
security.
Remove User Administrators can remove any user. Managers can only remove
operators.
Change Password Any security level can use this feature. Enter the old
password followed by the new password.
Who is logged in Security access window appears to show who is logged in and
their access level (view Figure 4.1.3-2).
24
View Log File opens a log of every user name that has logged on, including a
time and date stamp and a running count of entries.
ChemWell
4.2.1 Alignment
Under the Utilities menu,
select Alignment:
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Alignment (Continued)
Use the arrow buttons to position the probe correctly. The probe tip should be
centered about 3mm above the rear pin, as shown:
Side-toSide (blue)
Forward
and
Backward
(red)
Up and
Down
(green)
Forward
and Backward
(red)
Up and
Down
(green)
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ChemWell
Alignment (Continued)
To check new alignment, select Test.
When finished click Save, then click Next to continue with Step 2 of 2.
The next step prompts to
replace Rack 2 and place a
sample cup in position
number 96 in the back of
the sample rack (view
Figure 4.2.1-3).
Use the arrow keys to move the probe until it almost reaches the bottom of the
sample cup.
When the correct depth has been reached click Save and then the Close button.
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Alignment (Continued)
Select Probe vs. Plate from
the menu.
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Alignment (Continued)
Select Probe vs. Wash
Cup from the menu.
Press the
button.
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Alignment (Continued)
Insert a plate or strip tray
when prompted. Click the
probe button.
The plate will move under
the wash head and the
wash head will lower into
the wells.
The plate and wash head
should be positioned so that
the aspiration needles are
centered left to right, toward
the back of the wells;
touching but not pressing
on the bottoms of the wells.
Use the arrows to position
the wash head correctly.
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ChemWell
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31
This file can be saved and/or printed or filed for future reference.
32
ChemWell
This will allow the user to blank the four photometer channels on a wetted opticallyclear solution (example blanking solution included, 0.5N NaOH with 100L Triton X100/L). The ChemWell software will display which wells it will be using for channel
blanks (preferably, use a new set of wells), and then prompt to put Blanking Solution
in position 1 of Rack 1 (never use plain water).
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The ChemWell will then pipette the four blank wells, read, and store them, then do a
confirmatory reading. The absorbance values of the readings will be displayed and
should be 0 0.0050A. These blanks will automatically be subtracted from
absorbance readings. The result of the reading will be displayed in the bottom of the
window (Figure 4.2.5-3).
Result
If one of the values is not between 0 0.0050, follow the instructions and try doing
channel blanks again. Do make sure there are clean wells in the positions indicated
to run channel blanks again. If the user continues to obtain incorrect channel blanks,
notify the instrument service provider.
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Once the Self Test is completed, press the Details button to open the Self Test log in
Notepad (Reference Figure 4.2.6-2).
The Self Test log displays the date, time, status of Lamps, Blank, Pipetting Accuracy,
Photometer/Plate Positioning, Temperature, Blank Abs, Filter Volts, etc.
36
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37
Press the Test Current Voltages button to view the filter voltage readings for all four
channels at each of the eight wavelengths. (If nothing happens, wait for the
automatic lamp warm-up time.)
All filter voltages should be between 2.00 and 10.00 (reference Figure 4.2.7-2
Current Voltages Test Results). Lower readings might indicate that a lamp is
misaligned or partially blocked. Consult your Trouble Shooter Guide or contact your
instrument service provider if correct voltages cannot be achieved. The data storage
buttons on this window are for troubleshooting and are only used when instructed to
do so by service engineers. Click Close to exit.
If abnormally low voltage is detected, the user will be prompted to mark the wells
read by that lamp as unavailable. If not able to immediately replace the lamp at that
time, allow the software to mark the wells as unavailable until it can be replaced.
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ChemWell
NOTE: Type in
a description
of the problem
before packing
the data.
The default
setting is Pack
LOG files.
Select Pack
options from
the drop down
menu.
Options
include
packing root
files, log files,
assay files,
lot# files, and
rack files.
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40
ChemWell
The Report Creator application allows users the opportunity to create unique formats
for their reports. Reference Section 9, Launch Report Creator for an overview, and
instructions on how to get started, and sample reports.
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10
42
Initialize
Communication Window
Calibration Event
Lot # Registration
QC Tracking
Switch Mode
10 Sample Database
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4
6
5
This window displays the current status of the instrument including the temperatures.
Also shown are the currently loaded racks and plate. The software automatically
keeps track of which wells in the reaction plate have been used.
Feature:
Status
Window
Description:
The temperatures of the probe/coil and reaction
plate are continually displayed in the ChemWell
Status Window. The temperature reading of the
probe coil and plate are only accurate near 37C.
Item No.:
1
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43
Description:
Item No.:
Go Home
buttons
Reset
buttons
44
Save
Load
Edit
Verify
ChemWell
Feature:
Description:
Item No.:
Choose
Assay
Add
Calibration
Test
Information
Selections
Select the Curve option to insert a blank and a
calibrator for the assay into the work list. Select
multiple times to add more copies of each. This
button is not active if the user is running an
assay that does not require calibrators.
Select the Control option to add all of the
Controls specified in the assay. Press the
button multiple times to add multiple copies of
the controls.
NOTE: The user may also select calibrators,
controls, and blanks individually.
View
Results
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45
Description:
Click Save to save the current work list.
Item No.:
4
Activate
Selected
Button
46
Print
Preview
Print Report
ChemWell
Description:
Toggles between substances selected
(calibrators, controls) and calibration curves.
Item No.:
9
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47
3
2
This tab can be used to set up a quick and easy work list. NOTE: The drag and drop
feature allows reagents and sample racks to be changed within their rack location
and between racks as well.
Feature:
Enter
Sample IDs
Description:
Press the Add Numerical ID button to enter
samples by number.
Item No.:
1
48
ChemWell
Description:
Item No.:
The Work List area of the screen lists the IDs and
assays assigned to each, the number of
requested copies (Reps), and a column labeled
Urgent.
Export
button
Calibrate
button
Request
button
Verify the
location of
all samples.
Press the
Click to
Start button
when
finished
loading the
racks.
The tests
will now
begin.
NOTE: Use drag and drop feature to change reagent or sample locations within
their rack location and between racks as well.
ChemWell
49
Feature:
50
Description:
Item No.:
Layout Area
List
ChemWell
Description:
Item No.:
Select All
Action
buttons
ChemWell
51
Feature:
Description:
Item No.:
History
Checkbox
Sorting
Option
Magnifying
Glass Icon
52
ChemWell
Feature:
Description:
10
Item No.:
Search by
Date
By Name/ID
By Assay
Select All
Note: If needed, an Assay Report or a Calibration Report may be printed from the
Calibration window. See Section 4.3.2 Calibration Tab for more information.
ChemWell
53
54
Description:
Item No.:
Fold All
Print
Preview
Remove
Retest (add
to Sample
Tab)
Export
10
ChemWell
OPTION
DESCRIPTION
Initialize
Pause Engine
Press Pause Engine and all tasks pause; press again and the
instrument will resume the task from the point it was paused.
Pause Probe
Press Pause Probe and the probe with finish pipetting and wash the
probe before pausing. Probe will be paused until Pause Probe is
selected again; in the meanwhile, other tasks will continue.
Reload Assay
Files
Use this feature after editing or creating new assays with Assay Editor.
The new or edited assays are then added to the list of available assays
in ChemWell Manager.
Switch Mode
Change
Temperature
Change the temperature for specific tests. For instance, when running
the Performance Check, change to Room Temperature.
ChemWell
55
DESCRIPTION
Change Rack1
Change Rack2
LIS Import
Read the information that follows this table explaining the LIS Import
Option and examples of import and export files.
Multi-Plate Test
Used when running a plate that contains long incubation times. Other
tests, including entirely different modes, can be run by loading a
different plate. There is a reminder to reload the plates when time is
almost expired.
Communication
Window
Calibration Event
Exit
56
Import Process:
o
Export Process:
o
In the Report tab, user will select records and press Export button.
In the Save-As Type drop down list, the user will select LIS files (*.lis).
User types in a filename, and a folder, for the file and presses Save
button.
ChemWell
P|
OBR|
OBX|
L|
A|
A Carriage return is used to indicate the end of the line (220 is the maximum).
Record Layout Specifications
Minimum Requirements
Message Header
H|
Append to the Previous Record
A|
Patient Segment
Transmission Seq#| Patient-ID |
P|
Observation Order Segment
OBR| Sequence Number|
Patient Name |
Assay
Name
Observation
Value |
Units |
Sex|
Nature of
abnormal
checking
Address|
OBX|
Sequence Number|
Value Type|
Reference Abnormal
Range |
Flags |
Message Terminator
L|
Sequence Number|
Patient
Count | Line Count | Batch Number
NOTE: A solid bar (|) indicates the field is for future use. The bar delimiter is
necessary for correct formatting within the record.
ChemWell
57
| Doctor
File Examples:
58
ChemWell
OPTION
DESCRIPTION
Start of Day
End of Day
Wash Probe
Prime Syringes
Temperature On /
Temperature Off
Read Wells
Custom Script
ChemWell
59
4.4.4 QC Tracking
Enables Controls and Calibrators to be tracked using a Levy-Jennings chart. In past
versions, QC tracking could be accessed at the assay level through the QC tab. With
ChemWell this feature is accessed by selecting QC Tracking from the main menu.
60
ChemWell
QC Tracking (Continued)
1
Feature / Description:
Item No.:
ChemWell
61
4.4.5 Sample DB
Refer to Section 5.2.3 Sample Database Setup for details.
4.4.6 Settings
Refer to Section 4.2 Alignment Settings and Section 5 Running ChemWell for details
on Software Settings and Custom Report Settings.
4.4.7 Security
Refer to Section 4.1.2 Password Security and Logging In for more information.
4.4.8 Help
4.4.8.1 About
The About selection will open a window and display the version of the ChemWell
Manager installed in your instrument.
62
ChemWell
5. RUNNING CHEMWELL
This section will take you through the steps necessary to prepare for the days work and
set up a run using the ChemWell Manager.
NOTE: The example assays provided represent the most frequently used. If the need
arises to edit one of these assays or to create your own, refer to Section 6. Assay Editor.
If your ChemWell has a plate washer, you may choose Auto Wash Plate (shown
here as it appears with no plate washer) from the Management Menu. Activating this
option will allow the instrument to automatically wash the plate when finished with
tests. (This feature is not applicable when running EIAs.)
ChemWell
63
You may choose to keep numerical ID and sample ID records for 1 year, 3 years, 10
years or forever. However, whatever preferences you choose, all sample test records
are backed up monthly to an archive database.
To change the communication port, click on the
down arrow to display the optional settings; click
to select, click OK to accept.
The default temperatures are displayed for
chemistry mode and EIA mode. Setting choices
are: room temperature, 25 deg C, and 37 deg C.
Press OK when finished.
64
ChemWell
DESCRIPTION
Customize sample database field names, uncheck field
name from the list displayed if you do not want to use it.
ChemWell
65
DESCRIPTION
Washing Plate global settings used in Chemistry Mode.
66
ChemWell
DESCRIPTION
Set parameters for how to run the tests and how to handle
the results in Chemistry Mode:
Beep 60 seconds as a
reminder check to be
notified when verify plate
fails and/or when all tests
are finished
Automatic or manual
control of:
activating control
results
activating control
results
accepting sample
results
printing sample report
ChemWell
67
DESCRIPTION
Set parameters for how to run the tests and how to handle
the results in EIA Mode.
68
ChemWell
DESCRIPTION
Specify your preferences on the report appearance.
Figure A
ChemWell
69
DESCRIPTION
Specify optional data to print for different report types. You
may also specify if report should be printed jointly.
70
ChemWell
The Custom Report Template screen allows users to choose a report template for
each type of report they desire to run. Choose the type of report to run and click on
the Set Template button. The report will be formatted according to the chosen
template until the Custom Report template has been cleared by clicking on the Clear
button.
A
Result
report
templates
B
Assay mode
calibration
templates
C
Assay
specific
calibration
templates
ChemWell
71
72
ChemWell
After running the Start of Day program, visually check the sample handling tubing and the
syringes for the presence of any bubbles.
If bubbles are present, repeat the Start of Day program, tapping the tubing where the
bubbles are present.
If this does not eliminate trapped bubbles, perform the Weekly Alcohol Cleaning
procedure found in Section 5.2.1.1.
ChemWell
73
74
ChemWell
2) When first opened, the Sample Database window will not have any records to display.
3) Select the Edit button to enter Sample ID, Family Name, Given Name, etc. This will be
helpful as search criteria when searching the database. Press the Done button when
finished. NOTE: The Edit button toggles to Done.
4) An instructional dialog box will open.
Navigate through the fields on the screen by using the Tab or arrow keys on the
keyboard.
Delete a Sample ID by highlighting the record to delete and press the Delete key on the
keyboard.
ChemWell
75
Information entered in the keyword field will be matched to keywords entered in Special
Interpretation Groups (see Figure 6.5-1 Special Groups in Section 6.5).
76
ChemWell
2) Modify the information and then press the Done button to save the changes.
ChemWell
77
78
ChemWell
2) Click on File and select Save. Close the window when finished.
ChemWell
79
Search result
displayed
80
ChemWell
ChemWell
81
5.2.3 Calibrators
NOTE: Before starting any tests, perform the following checklist and correct any
problems.
9 Rack setups match the layout on the screen
9 Bottle caps and vial lids are removed
9 The probe pathway is clear of obstacles such as bottles or tubes that are too
tall, or covers that hang attached to tubes or bottles
9 There is a sufficient supply of de-ionized (DiH20) water in the Prime Bottle
9 There is sufficient room in the Waste Bottle
Before Samples can be read, Calibrators must be registered and read. Open the
Calibration Tab and choose Example Albumin from the Choose Assay drop down
menu. NOTE: For EIAs, calibrator (standard) values are set in the Assay Editor and
entering lot numbers for them is optional.
1
Lot # Registration
Open Lot # Registration
from the top menu.
2
Click the
Substance in
the left
column you
would like to
register.
3
Click
Register
New
Lot#.
82
ChemWell
Concentration Range
Specify standards concentration for curve calculation; specify range to monitor the
quality (optional). Highlight the field to change, type in new value.
Press the Close button to save.
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83
Select Curve from the drop-down menu. Press the New Curve button once for each
blank and calibrator you intend to run. Select Controls to add controls.
If you wish to save this as a Work List for validating your calibrators in the future,
press Save, choose a location, enter a name, and press OK.
Press Request; the Layout tab will open.
84
ChemWell
Verify locations.
Press the
Click to
Start button
if placements
are OK.
Figure 5.2.3-5 Verify Reagent, Calibrator, and Controls Are Properly Loaded
Load Sample and Reagent racks as instructed and press the All are Loaded button
(refer to Figure 5.2.3-5 Verify Reagent, Calibrator, and Controls Are Properly
Loaded). The Test List tab opens and the ChemWell begins the run. The status
and current step are both shown.
Figure 5.2.3-6 Test List tab shows the status of the current run
When ChemWell is finished reading, the Calibration Event window opens. This
window shows whether the new curves and controls were accepted. If the curve is
not accepted, this procedure must be repeated.
ChemWell
85
The controls will be accepted even if they read out of range if the Control Properties
are set to Warn and Continue. To check your Control Properties or change this
setting, see Section 6.7 in Assay Editor. If you do not want to see this window every
time, click the Do not automatically show up box in the bottom left corner of the
window (refer to Figure 5.2.3-7 Calibration Event). If checked, the Calibration Event
can only be viewed by selecting it from the Routines window or by pressing the F8
key on your keyboard at any time.
When selected, Calibration Event will display the blank, calibrator, and controls valid
for 7 days. After they expire, you will have to re-run the Calibrators to use that assay.
You may run more frequent recalibrations and control checks as often as you like. To
change the time valid, you must edit the assay using Assay Editor.
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ChemWell
Press Add Numerical ID. Type in the First ID and the total number of patients. In this
tutorial, we are using A01 as First ID and 20 Total (Refer to Section 4.3.3 Sample
Tab). Click OK to add the IDs.
Refer to Figure 5.3-2 Assigned Assays and click on each patient(s) and add tests
for them to the Work List. After pressing Request the Layout tab opens.
Use loading positions to correctly load the racks (refer to Figure 5.3-3 Layout Tab
with Load Positions).
NOTE: Press Add Sample ID to access IDs from the Sample Database.
ChemWell
87
Click on
Patient to
select.
Click Test
or Tests
to be added.
Then click
Add Test.
Print Work
List if
required.
Press
Request
to begin.
1
Locations for
samples
outlined.
2
Use these
Instructions
to load the
racks.
NOTE: Use the drag and drop feature to change reagent or sample locations within
their rack location and between racks as well.
88
ChemWell
The Test List tab opens as shown in Figure 5.3-4 Test List Tab Opens.
After the tests are complete, you must Accept, Delete, or Rerun the tests. Tests
must be accepted before they can be viewed in the Report tab. Click the Report tab
to get reports on all of the results (refer to Section 4.3.5 Report tab).
ChemWell
89
This will completely bleach the sample handling system, re-prime it with deionized water,
and rinse the wash head (if applicable) with deionized water. It is optional whether you turn
the unit off or not.
NOTE: It is important that you place deionized water in the Rinse bottle prior to
running End of Day.
90
ChemWell
6. ASSAY EDITOR
Assay Editor works in conjunction with ChemWell Manager. Although the biochemistry
assays used in most clinical laboratories are included and preprogrammed in the
ChemWell Manager software, there are times when you will need to create your own
assay or edit an existing one this is the purpose of Assay Editor. NOTE: Chapter 7 (if
included with this manual) details the use of Assay Editor for programming Enzyme
Immuno Assays (EIAs).
Access Assay Editor by pressing the icons, or from ChemWell Manager, click on Utilities
and select Launch Assay Editor. A login window will open; User ID and password are
both Admin.
ChemWell
91
There are eight main parts to the Assay Editor. The available options will depend upon
whether running chemistries or EIAs.
6
2
3
7
8
4
Item
1
2
3
4
5
6
7
8
92
Section Location
Main Menu and Toolbar - Section 6.1
Creating Assays - Section 6.2
Assays Steps - Section 6.3
Interpretation Settings - Section 6.4
Special Groups Assay Editor - Section 6.5
Standards - Section 6.6
Blank - Section 6.7
Controls - Section 6.8
ChemWell
6.1.1 Assay
New Chemistry - Clears all entries and allows building of a new biochemistry
Assay.
6.1.2 View
ChemWell
93
6.1.3 Substances
Use this menu to choose one of the Substances and manage the list. Managing the
list refers to adding: New, Edit or Delete current Substances.
94
ChemWell
.
Figure 6.1.3-4 Manage Standards
6.1.4 Panels
This feature allows you to set up and save panels of assays to be run as a group.
Use the Add and Remove buttons to edit the Panel Assays list. Assays can
belong to more than one panel. Used for biochemistries and EIAs.
ChemWell
95
BUN (2 Reagent)
6.1.5 Indices
Sometimes a test result is not a measurement, but a calculation made from other
measurements. To create an equation that calculates a test result, select New
Chemistry or EIA.
96
ChemWell
Description:
Item No.:
Index Name
Assays
Operators
Numbers
Backspace
Interpretation
Settings
Index
Formula
Editor
Index
Description
(Optional)
When making a Patient Report, the Index is reported only if there was a valid test
result for that patient for each of the Assays required to calculate the Index.
1
7
3
8
6
ChemWell
97
6.1.6 Security
Security Level
Disable Security
Enable Security
Create Manager
Create Operator
Remove Manager
Remove Operator
Open Assay
Save Assay
Open Panel
Save Panel
Open Index
Save Index
Create Substance
Edit Substance
Delete Substance
Administrator
Y
Y
Y
Y
Y
Y
Y
Y
Y
Y
Y
Y
Y
Y
Y
Manager
N
N
N
Y
N
Y
Y
Y
Y
Y
Y
Y
Y
Y
Y
Operator
N
N
N
N
N
N
Y
N
Y
N
Y
N
N
N
N
Feature
98
Description
Enabled
Logout
You are logged out and the Login screen appears and
waits for next user. Press Cancel to quit Assay Editor.
Remove User
ChemWell
Security (Continued)
Feature
Description
Change Password
Who is Logged In
ChemWell
99
6.1.7 Settings
100
ChemWell
ChemWell
101
6.1.9 Icons
To see the function each icon has, place the mouse cursor over the icon in Assay
Editor. A description will appear.
Create New Chemistry Assay. Clears all entries and allows building
of a new assay. It has the same function as the New Assay selection
in the Assay Menu.
Open Chemistry Assay. Open a dialogue box in order to select the
existing Assay for use. See Section 6.1.1 for more information.
Create a new EIA Assay
Open an existing EIA Assay
Save - Saves the current Assay under the name entered in the
Assay Definition Section. See Section 6.2 for more information.
Save As - Allows the Assay to be saved under a different name or to
save another copy of the Assay.
Print Assay - Prints the current Assay.
Manage Reagents Same function as selecting Reagents under the
Substances menu. See Section 6.1.3 for details.
Manage Controls Same function as selecting Controls under the
Substances menu. See Section 6.1.3 for details.
Manage Standards Same function as selecting Standards under
the Substances menu. See Section 6.1.3 for details.
Enable / Disable Security Access - Toggles Security to disabled
and enabled. See Section 6.1.6 for details.
Help - Opens the Help window. See Section 6.1.8 for details.
102
ChemWell
Chemistri
5
Figure 6.2-2 - For EIA Assays
Feature:
Description:
Item No.:
Assay Name
Assay Type
Temperature
Assay
Description
Assay Mode
ChemWell
103
Mode
Description
Absorbance Mode
Factor Mode
Adjust Factor for path length will adjust the package insert
factor (which is always written for a 1 cm path length). The
path length in Microwells varies with reaction volume.
Standard Mode
104
ChemWell
Mode
Description
Point-to-Point Mode
Regression Mode
and
ChemWell
105
Mode
Description
Regression Mode
(Continued)
Data may be entered for linear-linear, ln (= natural log)linear, linear-ln, or ln-ln calculations. A logit-log calculation is
also available. Absorbance, or ln of (1000 * absorbance), is
always on the Y axis. Concentration, or ln of concentration,
is always on the X axis.
1. Y= ABS, X=CONC - both the absorbance data (y) and
the concentration data (x) are linear.
2. Y=Ln (1000*ABS), X=Conc - the natural log of the
absorbance is plotted against the concentration. The
absorbance values are multiplied by 1000 before taking the
logs.
3. Y=ABS, X=Ln(Conc) - absorbance is plotted against
the natural log of the concentration.
4. Y= Ln (1000*ABS), X=Ln(Conc) - the natural log of the
absorbance is plotted against the natural log of the
concentration.
5. Select Y= Logit(Abs), X= Log(Conc) to calculate
unknowns using the equation: Abs Logit = Ln [(sample/0
cal) / 1-(sample/0 cal)]
When using the Logit calculation, the 0 calibrator is not
plotted as part of the curve; it is used only for the
calculations.
6. Y=Log(1000*Abs), X=Conc - the base-10 log of the
absorbance is plotted against the concentration. The
absorbance values are multiplied by 1000 before taking the
logs.
7. Y=Abs, X=Log(Conc) - absorbance is plotted against
the base-10 log of the concentration.
8. Y=Log(1000*ABS), X=Log(Conc) -- the base-10 log of
the absorbance is plotted against the base-10 log of the
concentration.
In the Linear Regression mode, resulting concentrations will
be the same no matter what base is used (ln or log).
However, slopes and intercepts will vary. When using a
format which calculates the ln or log of the concentration,
(do not use 0.0 for the concentration, since ln 0 and log 0
are not defined. If a 0.0 concentration Calibrator is used, it
will be ignored when the regression is calculated.) Note that
in the logarithmic modes, any values which require the log of
a zero or negative number are invalid, and will either
invalidate the curve (if in the Calibrators) or invalidate the
specimen. Likewise, when using ln of 1000*Abs, the
absorbance values must be nonzero and positive.
106
ChemWell
Mode
Description
Cubic Spline
(Constrained) Mode
%Absorbance
ChemWell
107
108
ChemWell
ChemWell
109
Advanced Parameters
1
2
3
4
Feature:
Description:
Item No.:
Aspiration
Speed
Air Gap
Dispense
Speed
Dispense
Height
A. MAIN SETTINGS
Dilution Ratio- Ratio of sample volume to total volume
Total Volume- Total predilution volume
Sample Volume: Sample volume to be added to the diluent to make the
dilution.
Advanced Button (optional): Opens the advanced parameter dialog, where
the Aspiration Speed and Air Gap can be changed.
Dilute to Plate (instead of sample rack): Check this option if you want the
dilution to be sent directly to the well.
Set the Volumes Manually: Manually specify the volume of Sample and
diluent to be used for the predilution.
Diluent Volume: Amount of diluent to be added to a Sample.
110
ChemWell
B. ASPIRATION SETTINGS
Aspirate Separately: If this option is not checked, both the diluent and the
Sample are aspirated in a single step, and then dispensed together to the vial
on the sample rack.
Separation Air Pocket:
What should be diluted (in addition to Samples):
o
Dilute Standards: Check this option if you want to dilute both samples
and standards.
Dilute Controls: Check this option if you want to dilute both samples
and controls.
Use Diluent For Blank: Check this option if you want to use the diluent
for blanking.
ChemWell
111
Select Add Reagent from the list. Select an existing Substance or Reagent, or,
create a new one.
1
2
3
4
Feature:
112
Description:
Item No.:
Change
button
Volume
Exclude
Blanks
When
Dispensing
Dispense
One By One
ChemWell
Feature:
Description:
Item No.:
Aspiration
Speed
Air Gap
Pre-warm
time
Dispense
Speed
Dispense
Height
ChemWell
113
Feature:
Special
Volumes
Description:
Item No.:
114
ChemWell
Enables an incubation
(lag) time in hh:mm:ss
format, where hh=hours,
mm=minutes,
ss=seconds
NOTE: For Rate Mode test, this is where the lag time is set.
ChemWell
115
6.3.1.4 Read
NOTE: If using a differential blank or sample, a Read step must be added both
before and after the Incubation step.
1
2
Feature:
Description:
Item No.:
Primary
Filter
Differential
Filter
NOTE: A differential filter should always be used if at all possible when running
assays in ChemWell. Some assay inserts do not specify to use a differential filter,
but when running assays in microplates as in ChemWell, a differential reading filter
usually improves results.
It is important to choose a differential wavelength which is at an absorbance
minimum in the absorbance spectrum of your reacted reagent.
If your assay insert does not specify a differential wavelength to use for your
reagent and there is no corresponding ChemWell example to use, contact the
reagent manufacturer for the best wavelength choice.
116
ChemWell
Differential Blanking
Some assays, such as Bilirubin, require the use of a sample blank. Others, such as
Calcium, may require a reagent blank on each well in order to eliminate possible
contamination and variations from well to well. In these cases, differential blanking
may be programmed by simply adding another Read step into the Assay steps.
To program the reagent blank on each well, have the reagent pipetted first and then
read after a short incubation. After the Sample is added and another incubation step
added, program the second read and the software will report the subtracted
absorbance of each well for the calculations.
If you are programming a Sample blank assay, first pipette the samples, then the R1
reagent, and then a Read step. Then program an R2 reagent step with another
incubate and Read step added. The subtraction is automatically handled by the
software.
ChemWell
117
NOTE: The Interval and Number of Reads selections are not available if Fixed
Time is checked.
118
ChemWell
ChemWell
119
NOTE: The probe is washed automatically with water after each dispense no user
defined step is needed.
Volume: Desired cleanser
volume to be aspirated by
the probe.
120
ChemWell
ChemWell
121
122
ChemWell
Feature:
Description:
Item No.:
Units
# of
Decimals
Normal
Range
ChemWell
123
Description:
You can also define the linear (valid) test range.
Item No.:
3
Positive /
Negative
124
ChemWell
2
Figure 6.5-1 Special Groups
Special Groups can be defined based on Age, Gender, or Keyword. In Figure 6.5-2
Special Group Edit Menu, Adult is defined as a patient who is greater than 18 years
old.
To access Special Groups, click on Normal Range (see diagram box 1) in the
Interpretation Settings section of the screen. The Special Groups button (see diagram
box 2) will appear in the lower left hand corner of the screen.
ChemWell
125
The Special Groups Interpretation window will open. A list of defined groups will display.
Defined groups may be added, edited, and deleted.
If Edit Group is chosen, the Special Group Edit window will open. The Group ID is the
group definition. Age range and gender may be selected. Keywords should be separated
by a comma. The keyword characterizes the group. It may be matched with a keyword in
the Sample ID database or entered (for numerical ID) when assigning tests for a sample.
Example: Pregnant, non-smoker.
126
ChemWell
Keywords can also be used to determine the group assignment. When the keyword is
found in the patient database keyword field that patient will be automatically assigned to
the defined group. It is important to note that the text used to name the Group ID is not
searched by the database; the user must enter the keyword(s) used to define the group
in the Keyword text box. Figure 6.5-3 Special Group Edit Using Keyword(s) is an
example of a special group definition for a pregnant patient.
Refer to the ChemWell Manager section for entering keywords in the Patient Database.
When running samples with numerical IDs the group can be manually assigned at run time.
ChemWell
127
6.6 Standards
Standards are used to create the curve for calculating concentration from absorbance.
Standards are available in all calculation modes except Absorbance and Factor. Assay
editor has one standard predefined called Standard.
1
Add Button
Properties
Arrow Keys
Remove
Description:
Select an existing Standard or create a new one.
Item No.:
1
128
ChemWell
Standards (Continued)
Feature:
Description:
Item No.:
2
Standard
Properties
Advanced Button
(Optional)
ChemWell
129
Standards (Continued)
Feature:
Standard
Properties
(Continued)
Description:
Item No.:
2
D
E
F
G
Remove
Curve Valid
Time
130
ChemWell
6.7 Blank
Using a Blank is optional in all modes except Standard mode. To use a Blank, check the
box next to Blank Used (Figure 6.7-1).
Blank Properties Set up the Absorbance Range, Out of Range Action, and the Valid
Time for the Blank (Figure 6.7-2).
Warn and Continue Continue the test when absorbance is out of the range, but
put a warning to the report.
2.
Valid Time: Blank result valid time in days and hours. Default value is 7 days.
Advanced Button (Optional). This should only be used if you need to set up different
parameters than in the Add Sample Step (Figure 6.7-3).
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131
6.8 Controls
1
Add
Properties
Arrow Keys
Remove
Controls are used to validate tests (see Figure 6.8-1). Assay editor has two controls
predefined: Normal Control and Abnormal Control. New controls can be defined if
needed.
Feature:
Add
Description:
Select an existing Control or create a new one.
Item No.:
1
Properties
A
B
C
Figure 6.8-3 Control Properties
132
ChemWell
Controls (Continued)
Feature:
Properties
(Continued)
Description:
A - Action to take when result is out of range:
Item No.:
2
D
E
ChemWell
133
Controls (Continued)
Feature:
Advanced
Button
(Optional)
(Continued)
Description:
Item No.:
2
F
G
H
I
134
Arrow Keys
Select a Control in the list to the left and click the arrow
for the direction in which to move it in the list (reference
Figure 6.8-1).
Remove
ChemWell
1
6
2
3
4
5
Feature:
Description:
Item No.:
Temperature
Assay
Description
Assay Mode
Assay Name
Type
Flat bottom
wells
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COV = X*mean(CC) + F
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Use this equation when ChemWell must calculate the cutoff value based
upon readings or positive and/or negative controls.
ChemWell calculates the mean of the positives and the mean of the
negatives.
COV = X * mean(Nc) + F
Use this equation if only a negative control is used to determine the COV.
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Use this equation if only a positive control is used to determine the COV.
For interpretation, you may chose either the Regular Cut Off Mode
(positive >= cutoff, negative < cutoff), or the Reverse Cut Off Mode. With
the Reverse Cut Off option, the Samples with values lower than the cut
off are labeled as positive. If you choose this option, be careful to follow
the < and > signs in the prompts for entering cut offs and ranges.
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7.1.1.5 %Absorbance
This mode is a point-to-point calibration mode which calculates a % absorbance
for each sample and calibrator in addition to a concentration value. The highest
absorbance calibrator is assigned a value of 100% and each sample and
calibrator absorbance is calculated as a percentage of this value and displayed in
the Interpretation field of the report. This mode does not support ln, logit or log
scales for the absorbance axis.
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For example, add this step after pipetting the enzyme conjugate to eliminate
conjugate contamination of the substrate. NOTE: If the substrate were to become
contaminated with conjugate, the wells will develop extra color when the substrate is
added and this could lead to inaccurate results. Inclusion of this step may need to be
determined for each specific analyte and test kit, and may not be necessary for all
assays.
Sample Carry Over
Extra Clean Probe steps may also be programmed between each sample pipetting
step. While not necessary for most assays, assays with highly sensitive samples
such as HIV, Hepatitis, and human chorionic hormone (hCG), may require this step.
The need for this step should be determined for your specific assay kit.
Test for carry over by running an extremely high sample followed by a low negative
sample to determine if there is any carry over detected which could result in a false
positive result. This step is not recommended if it is not necessary as it will decrease
your sample throughput. Use of either 1N HCI or 10% bleach solution is suggested
for cleaning the probe.
To add the Clean Probe Step:
From the Assay Editor screen,
select Add Step
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Figure 7.2.1-3 Extra Clean Probe Steps may be desired for highly sensitive samples
such as HIV, Hepatitis, and Human Chorionic Hormone (hCG).
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The Rinse Probe Step Parameters window will open and will allow the user to set
the volume of rinse to be used and the number of times the rinse probe step will be
repeated.
Adjust volume to
be used in Rinse
Probe Step.
Maximum 2000 l.
Adjust number of
times rinse will
repeat. Maximum
10 times.
Result displayed in
Assay Editor
display.
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Incubate (Continued)
The Incubate Step Parameters window will open:
If multiple assays are going to be run simultaneously, the temperature switch should be
used with caution. A temperature change in one assay will affect the entire plate of
assays.
At run time, the assay temperature switches for each assay are shown in the EIA Work
Scheduler before the assays are started. This allows the user to assess if a temperature
change in one assay will adversely affect other simultaneously running assays.
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ADVANCED
The Wash Step Parameters window will open allowing the user to set the wash to repeat
for a maximum of 10 times. The wash volume may be set between 25 to 500 l. The
soak time range is between 0 and 60 seconds.
Selecting the Advanced button opens the Wash Well Sub-steps Menu:
Edit, add or
delete a sub
step
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The result of the settings selected in the Wash Well Sub-steps Menu will display in the
Wash Wells Sub Step Parameters window:
Single Aspirate
Double Aspirate
Dispense Volume
(25 to 500 l)
Soak Time
(0 to 60 seconds)
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7.3 QC Criteria
In New Assay EIA, the QC Criteria button will display as shown in Figure 7.3-1.
NOTE: There must be substances (standards, controls, blank) in the assay before
selecting QC Criteria.
Clicking the QC button brings up the QC Criteria window shown in Figure 7.3-1. From
this window one can add new control criteria, delete, edit or change the checked order of
the control criteria defined in the Assay.
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Options to delete all, delete, scroll using arrow keys, and edit assay criteria are
presented.
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If no suitable template exists for the required equation, define a custom equation by
clicking on the General Formula button. This brings up the window shown in Figure 7.3-3
Cutoff QC General Criterion. By clicking on the Substancesn, Operatorso, and
Numbersp you can enter any QC equation that you would like. This General Formula
option is also accessible from the QC button in assay modes other than cut off mode.
n
o
p
Figure 7.3.3 Cutoff QC General Criterion
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NOTES:
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When multiple Assays are run simultaneously, the software will automatically
generate the best run order based on the shortest total completion time. The desired
run order can be changed by selecting an alternate schedule. The software will delay
the start of certain assays so that conflicts do not occur.
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4. After reviewing the work schedule, click on OK. The Wash bottle selection window
(Figure 8.1-3 Select Bottle) will be displayed. Select whether the Assays will use
the Wash or the Rinse bottle for the plate washing steps. Click the OK button.
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5. Place all the needed reagents and samples into the correct rack locations, place the
proper-coated EIA strips into a plastic strip tray, and click All are Loaded. The
Assay processing will begin.
The time remaining for completion of each
Calibrator/Standard, Control and Sample is displayed on the screen (refer to Figure
8.1-4 Test List).
Right clicking on any of the Sample rows will display the Step Log (refer to Figure
8.1-5) for that Sample. This can be helpful for verifying that all the Assay events
have occurred reasonably on time. For example: if a reagent runs out during a test
and has to be refilled, the timing in this window can help determine whether to accept
a result or delete it.
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Check the Assay processing status by clicking on View Schedule button. This will
display an approximated time line of the Assay processing (refer to Figure 8.1-6
EIA Work Schedule).
When Assays are complete the curve can be accepted. Patient concentrations will be
calculated. If controls are run in an Assay, the Statistics can be displayed. Select the
Controls with the left mouse button and hold down the Ctrl key. (Refer to Figure
8.1-7 Statistics.)
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Click on
the
Accept
button
to
accept
results.
NOTE: Calibrators must be accepted and activated before samples can be accepted.
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Once the calibrators have been moved into the Calibration Tab they need to be
activated. However, selecting the calibration does not make the calibration graph
visible. Select the assay from the dropdown list and then click on the graph icon
(reference Figure 8.2-2) and the calibration curve will display on the right hand side
of the screen (reference Figure 8.2-3).
Select an
assay from
the drop
down list.
Click on the
graph icon
button to
display the
calibration
curve.
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The curve which is active is displayed on the bottom of the screen. This may be the
previously stored curve or a newly activated curve. Before the curve is activated it can be
reviewed for any adverse outlying calibrators. If outlier values are seen for any of the
calibrators, these may be removed by unchecking the check box next to this calibrator.
Click on
check box
to unselect
a record.
Click on the
Activate
Selected
button to
display the
curve in the
lower
display
area.
Figure 8.2-4 Calibration curve displayed based on selected records
The resulting calibration curve is shown in the upper graph (reference Figure 8.2-4).
Once you are satisfied with the calibration curve in the upper graph, click the Activate
Selected button and this will move the curve from the upper graph to the lower current
graph (reference Figure 8.2-5).
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At this point concentration values will be calculated for the samples and displayed in the
Test List Tab.
The samples can now be accepted by clicking on the Accept button (reference Figure
8.2-6). The sample results will be moved from the Test List Tab to the Report Tab where
they are automatically stored in the ChemWell database and may be printed in reports.
Click on
the
Accept
button to
accept.
Figure 8.2-6 Click on the Accept button to accept the sample results
Your preference for accepting and activating curve and sample results can be set to
occur manually or automatically in the EIA and Chemistry Strategy settings (reference
the General Settings section).
Manually accepting results has the advantage that you can look at the Step Log for any
individual calibrator or sample to verify that all assay steps were performed on time in the
event of a low reagent or instrument error. Once the samples are moved from the Test
List this Step Log is lost.
Manually activating the calibration curve has the advantage that the curve can be
reviewed for calibrator outliers and edited before it is used to calculate sample
concentrations.
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In the picture below, a TSH standard curve is displayed. This assay uses a 2nd order
polynomial curve fit. Moving the mouse pointer over the plotted curve will display the
fit parameters.
Clicking on the Test List tab will display the patient results (sample shown below.)
This data shows that the first copy of standard 5 appears incorrect. By checking the
boxes to the left of each standard, a corrected curve can be generated.
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Once a satisfactory curve is generated, clicking on the Activate Selected button will
cause this curve to be the current standard curve in use and will update the
concentration values of the samples in the Sample Tab. The corrected curve is
shown below in Figure 8.3.1-3 TSH Results, Edited. The patient sample results are
now updated, which you can see by clicking on the Test List tab.
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You can now choose to accept or delete any of the sample results by clicking on the
buttons.
In Figure 8.3.1-5 Accepted Results, all Samples are selected.
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The resulting concentration values for the samples run are shown below in Figure
8.3.2-2 TSH Results.
In Figure 8.3.2-3 TSH Curve -10% Factor below the calibration curve is adjusted by
-10%. Factor adjustments occur immediately and do not require clicking on the
Activate Selected button.
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The new concentration values are displayed in the Sample Tab as shown below in
Figure 8.3.2-4 TSH Results:
The percent adjust feature can be used when stored curves are used and there is
evidence that the current run has resulted in increased or decreased absorbance
levels than what is expected.
NOTE: Decreasing the standard curve by a percentage will result in increasing the
sample concentration values.
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8.3.3 Adjusting Curves by Running Less than All the Calibrator Values
Less than all the calibrators used in an assay can be run and the stored curve can be
adjusted accordingly. The adjustment factor will be calculated based on the average
percent change of all the new calibrators run compared to their stored absorbance
values. The new curve will be generated from the new calibrator(s) absorbance
values which are currently run and the adjusted absorbance values of the remaining
calibrators from the stored curve. This feature can be used to control for changes in
reagent activity when using stored curves.
In the Figure 8.3.3-1 TSH Adjusted With Standard 5, TSH Standard 5 is used to
adjust the stored curve shown in Figure 8.3.2-1 TSH Curve 0% Factor. Instead of
requesting an entire new curve, Standard 5 is requested individually.
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Once activated the original absorbance values remain, but the new calculated
concentration values of the standards are displayed.
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Even though the samples show decreased absorbance values similar to the one
adjustment standard run, the resulting concentration values for the samples are the
same as when they were run with the original complete standard curve (see Figure
8.3.2-4 TSH Results).
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The Report Creator application allows users the opportunity to create unique formats
for their reports. The Overview section that follows provides a short description of
the options available. The Getting Started section explains each feature in greater
detail.
The Custom Report Settings section provides information on using pre-defined
report templates if creating a unique report is not desired.
Overview use Report Creator to create/format reports
Execute the Report Creator application from the Manager Menu by clicking
on Utilities, and then select Launch Report Creator from the drop down menu
(see Section 9.1 Getting Started). A blank report will display.
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170
Report Objects. Report objects can be used on any report. Report objects
provide sorted data that can be placed anywhere in the report. Note that the
default is sorted data for multiple assays. Also, Patient Data must exist in the
Sample Database in order for patient data to appear in the report. Report
objects have properties that can be formatted, such as alignment, border,
etc. Report objects that can be added to the report are:
o Grid sorted
o Patient data
Layout. Layout provides the ability to align data as desired in the report.
Layout can be used with any report. Use the zoom to fit feature to place an
object. The snap to grid feature provides ease of placement of general
objects. Modify settings from pixels to inches, margins, width of objects etc.
Layout features that can be used for the report are:
o Align
o Zoom to fit
o Snap to grid
o Settings
View. View features the ability to display the toolbar, status bar, set grid lines
on or off, display the setting for the margins for ease of placing the objects
onto the report grid.
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Report Samples. A variety of reports have been supplied at the end of the
Report Creator section as examples of how reports can be formatted.
The Assay Report sample below displays the default column headings and
body outline.
Click on File
Close to close
the white
screen; click
on File Open,
select Assay
Report.rpt, and
click on the
Open button.
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Maximize the report screen, mouse click on the report, use the scroll
wheel on the mouse to zoom in, or click on Layout, Align, Zoom In.
Right mouse click on the report, the Properties window will display.
171
The data properties dialog box shows the default column headings, width
sizes, thickness of the column dividers, border thickness, solid line style
etc. Select settings on the properties window to affect the report format.
To save the file, click on File Save As, type in a file name, press the Save
button. Note that the default report location is RptCustom and .rpt is the
default file extension.
Highlight a
column on the
list, move the
column up or
down the list by
using the Move
up Move down
buttons; add or
delete column
headings;
apply color to
the lines; adjust
the thickness of
the lines, etc.
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A blank report will appear. Report Creator opens an untitled report. Assign a report
name by using File Save As.
Click on maximize to enlarge the view of the work area of the report screen.
NOTE:
Report
Creator
opens an
untitled
report.
Assign a
report
name by
using File
Save As.
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File New
Click on File to reveal the drop down menu with the following options: New, Open,
Print Setup, Exit.
The following tables identify the Report Creator menu options and describe each
feature found on the drop down menus.
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Feature
Add box
Add ellipse
Add line
Add label
Add field
Add picture
Outline Body
Object
properties
Description
Draws a box; enables user to click and
drag a box
Draws an oval; enables user to click and
drag an oval
Draws a line; enables user to click and
drag a line
Draws a text box; enables user to click and
drag a text box
Draws a box labeled field name
Draws a box; allows user to insert an
image from browser
Defines the body of the report; adds
structure to the report
Select object properties after selecting the
object; allows user to designate alignment,
color of line, fill, font, border, etc. See
specific object properties.
Output
Fieldname
Image
Structured output
User designated
properties
Placing an object
When a feature from the drop down menu is selected, the mouse pointer will change
to crosshairs. Click to where you want to begin an object, and drag the mouse
pointer to where the object should end. Release the mouse pointer and the object
appears. To move the object, click on the center of the object, crosshair arrows will
appear and highlight the edges of the object with small squares. Use the up, down,
left, right arrows on the keyboard to nudge the object to the position desired.
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Label Variables
To manage data on your reports, consider using the label variables found under label
properties.
Place the label object at the desired location in your report. Click on the label object,
click on Object Properties. Type the label variable in the Label properties window.
Note that you may adjust the placement by left or right justification or centering.
The available variables are:
Variable:
[%page%]
[%date%]
[%time%]
[%AssayName%]
[%AssayUnits%]
[%RunDate%]
[%RunTime%]
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Output:
Prints page number
Prints current date
Prints current time
Prints assay name (intended for use in calibration reports
only)
Prints assay units (can be used in a grid object)
Prints the date the test was run
Prints the time the test was run
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Sample
general
objects:
box,
ellipse,
line,
label,
field,
picture.
Sample of
box object
expanded
larger.
Sample of
box object
selected.
Change the
appearance
Change the
appearance or
properties of an
object by right
clicking on the
object and
selecting
Properties
from the drop
down menu.
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The objects property box will display. In our example, a box object was selected
therefore the box properties window appears.
Box Properties
Feature
Show border
Thickness
Style
Color
Fill object
Cancel
OK
Description
Draws a border around the box object.
This is the default setting. Click on Show
border to remove the border from the box;
the border will be invisible.
Allows the user to set the thickness of the
lines of the border
Border styles include dashed, dotted, solid.
Solid is the default.
Border color defaults to black. Click on
Color, select a color, and click OK.
Default setting unfilled object. Click on Fill
object to fill object with color. Click on
Color, select color, click OK. Object
displays filled with color selected.
Cancels selection; closes properties
window
Accepts and applies selection; closes
properties window.
Output
Border
No border
Desired line thickness
Dashed, dotted, solid
border line
Default black border
Desired Border color
Default unfilled
Desired fill color
Cancels selection;
closes properties
window
Applies selection;
closes properties
window
An alternative to right clicking on the object to arrive at the object properties window
is to left click on the object, click on the General Objects, and then click on Object
properties from the drop down menu.
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Ellipse Properties
Feature
Show border
Thickness
Style
Color
Fill object
Cancel
OK
ChemWell
Description
Draws a border around the box object.
This is the default setting. Click on Show
border to remove the border from the box;
the border will be invisible.
Allows the user to set the thickness of the
lines of the border
Border styles include dashed, dotted, and
solid. Solid is the default.
Border color defaults to black. Click on
Color, select a color, and click OK.
Default setting unfilled object. Click on Fill
object to fill object with color. Click on
Color, select color, click OK. Object
displays filled with color selected.
Cancels selection; closes properties
window
Accepts and applies selection; closes
properties window.
Output
Border
No border
Desired line thickness
Dashed, dotted, solid
border line
Default black border
Desired Border color
Default unfilled
Desired fill color
Cancels selection;
closes properties
window
Applies selection;
closes properties
window
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Line Properties
Feature
Thickness
Style
Color
Cancel
OK
Description
Allows the user to set the thickness of the
line
Line styles include dashed, dotted, and
solid. Solid is the default.
Line color defaults to black. Click on Color,
select a color, and click OK.
Cancels selection; closes properties
window
Accepts and applies selection; closes
properties window.
Output
Desired line thickness
Dashed, dotted, solid
line
Default black line
Desired line color
Cancels selection;
closes properties
window
Applies selection;
closes properties
window
Label Properties
Feature
Label
Justification
Font
180
Description
Assign a name to the label by typing over
the word label in display
Align text; left justification is the default
setting. Choose to center or right align.
Select the font style, effect, color and size
Cancel
OK
Output
Desired label
Label alignment
Desired font style,
color, effect, size
Does not apply
selection; closes
properties window
Applies selection;
closes properties
window
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Field Properties
Feature
Fieldname
Justification
Font
Description
Assign a name to the field by typing over
the word fieldname in display
Align fieldname; left justification is the
default setting. Choose to center or right
align.
Select the font style, effect, color and size
Cancel
OK
ChemWell
Output
Desired fieldname
Fieldname alignment
Desired font style,
color, effect, size
Cancels selection;
closes properties
window
Applies selection;
closes properties
window
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Picture Properties
Feature
File
Show border
Thickness
Style
Color
Cancel
OK
182
Description
Click on browse box to open browser;
allows a picture to be selected and placed
in the picture box (graphs, logos etc.);
image will display in Preview window.
Draws a border around the box object.
This is the default setting. Click on Show
border to remove the border from the box;
the border will be invisible.
Allows the user to set the thickness of the
lines of the border
Border styles include dashed, dotted, and
solid. Solid is the default.
Border color defaults to black. Click on
Color, select a color, and click OK.
Cancels selection; closes properties
window
Accepts and applies selection; closes
properties window.
Output
Desired picture (logo,
image, graph, etc.)
Border
No border
Desired line thickness
Dashed, dotted, solid
border line
Default black border
Desired Border color
Cancels selection;
closes properties
window
Applies selection;
closes properties
window
ChemWell
Feature
Add assay
information
Description
Draws a box labeled Assay Information
Add assay
substances
Add standard
curve
Add curve
formula
Add table
Add table
statistics
Add assay
steps
Add assay qcc
Object
properties
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Output
183
Change the
appearance
Change the
appearance or
properties of an
object by right
clicking on the
object and
selecting
Properties
from the drop
down menu.
An alternative to right clicking on the object to arrive at the object properties window
is to left click on the object, click on the Calibration Objects, and click on Object
properties from the drop down menu.
The objects property box will display. In our example, Add assay information was
selected so the Assay information properties window appears.
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Feature
Two Columns
Label Font
Description
Allows the user to set the number of
columns to one or two. Two columns is the
default.
Select the font style, effect, color and size
Font
Cancel
OK
ChemWell
Output
Desired number of
columns
Desired font style,
color, effect, size
Desired font style,
color, effect, size
Cancels selection;
closes properties
window
Applies selection;
closes properties
window
185
Feature
Font
Description
Select the font style, effect, color and size
Cancel
OK
Output
Desired font style,
color, effect, size
Cancels selection;
closes properties
window
Applies selection;
closes properties
window
Feature
Show border
Thickness
Style
Cancel
OK
186
Description
Draws a border around the box object.
This is the default setting. Click on Show
border to remove the border from the box;
the border will be invisible.
Allows the user to set the thickness of the
lines of the border
Border styles include dashed, dotted, and
solid. Solid is the default.
Cancels selection; closes properties
window
Accepts and applies selection; closes
properties window.
Output
Border
No border
Desired line thickness
Dashed, dotted, solid
border line
Cancels selection;
closes properties
window
Applies selection;
closes properties
window
ChemWell
Feature
Font
Cancel
OK
Description
Select the font style, effect, color and
size
Cancels selection; closes properties
window
Accepts and applies selection; closes
properties window.
Output
Desired font style,
color, effect, size
Cancels selection;
closes properties
window
Applies selection;
closes properties
window
Table Properties
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187
Description
Allows user to assign a name to the
grid
Add/edit column:
Output
Desired grid name
Choose a column heading from the
list provided.
Click on Title button to create a
column heading.
SampleID
Assay Name
Reading
Absorbance
Concentration
Interpretation
RefRange
Note
Time
Position
Graph
Replicates
Absorbances
Target Abs
Mean Abs
SD Abs
CV Abs
Diff Abs
Concentrations
Target Conc
Mean Conc
SD Conc
CV Conc
Diff Conc
Border
No border
Show row
divider
No divider
Divider
Show
column
divider
No divider
Divider
Style
Show
border
Thickness
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Description
Border color defaults to black. Click
on Color, select a color, and click
OK.
Measurement Pixels, inches or centimeters
Cancel
Cancels selection; closes properties
window
OK
Accepts and applies selection;
closes properties window.
ChemWell
Output
Default black border
Desired Border color
Desired output
Cancels selection; closes
properties window
Applies selection; closes properties
window
189
Feature
Name
Columns
Description
Allows user to assign a name to the
grid statistic
Add/edit column:
Output
Desired grid statistic name
Choose a column heading from the
list provided.
Click on Title button to create a
column heading.
190
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Thickness
Show row
divider
Show column
divider
Style
Color
Measurement
Cancel
OK
ChemWell
Description
Draws a border around the box object.
This is the default setting. Click on Show
border to remove the border from the box;
the border will be invisible.
Allows the user to set the thickness of the
lines of the border
Draws dividers between the rows. This is
the default setting. Click on Show row
dividers to display on report.
Draws dividers between the columns. This
is the default setting. Click on Show
column dividers to display on report.
Border styles include dashed, dotted, and
solid. Solid is the default.
Border color defaults to black. Click on
Color, select a color, and click OK.
Pixels, inches or centimeters
Cancels selection; closes properties
window
Accepts and applies selection; closes
properties window.
Output
Border
No border
Desired line thickness
No divider
Divider
No divider
Divider
Dashed, dotted, solid
border line
Default black border
Desired Border color
Desired output
Cancels selection;
closes properties
window
Applies selection;
closes properties
window
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192
Feature
Step Font
Description
Select the font style, effect, color and size
SubStep Font
Cancel
OK
Output
Desired font style,
color, effect, size
Desired font style,
color, effect, size
Cancels selection;
closes properties
window
Applies selection;
closes properties
window
ChemWell
Feature
Needs more
than 1 line per
QCC
Font
Description
Default setting is more than 1 line per QC
Criteria; based on the length of the formula
Output
Formula displayed
regardless of length
Cancel
OK
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193
Feature
Add grid
sorted
Add patient
data
Description
Default is sorted data for multiple assays
Object
properties
Output
Sorted data by
default
Data displayed in
report if data exists in
the Sample Database
User designated
properties
Feature
Name
194
Description
Allows user to assign a name to the
grid groups sorted
Output
Desired grid groups sorted name
ChemWell
Description
User may set desired row height
Output
Desired row height
Columns
Add/edit column:
SampleID
Assay Name
Reading
Absorbance
Concentration
Interpretation
RefRange
Note
Time
Position
Graph
Replicates
Show border
Thickness
Show row
divider
Show column
divider
Style
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ChemWell
Absorbances
Target Abs
Mean Abs
SD Abs
CV Abs
Diff Abs
Concentrations
Target Conc
Mean Conc
SD Conc
CV Conc
Diff Conc
Border
No border
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Description
Pixels, inches or centimeters
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Cancel
OK
Output
Desired output
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color, effect, size
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closes properties
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Applies selection;
closes properties
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Feature
Two Columns
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Label Font
Description
Default setting; uncheck box to format as
one column
Select the font style, effect, color and size
Font
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Output
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Desired font style,
color, effect, size
Desired font style,
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9.9 Layout
Align
Zoom to fit
This option allows user a closer view of the grid to align data as desired.
Snap to Grid
This option allows user ease of placement of general objects.
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9.10 View
View allows user to display the Toolbar, the Status Bar, set grid lines on or off, and
set margins. Example shows grid lines on.
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Patient Report
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Sample Report
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NOTES:
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10. TROUBLESHOOTING
10.1 Flags and Error Messages
Flags are warning messages to the user of a possible problem condition that will need to be
corrected. The instrument will continue to operate under these conditions. An example of a
Flag is Wash Bottle is Low.
Error Messages indicate a condition that causes the instrument to be unable to proceed,
and must be corrected before the instrument is used further. An example of an Error
Message is Probe Z axis is jammed.
10.1.1 Flags
Possible Insufficient Aspiration:
This flag may appear:
Volume Calculation:
ChemWell automatically detects liquid surfaces and makes approximate volume
calculations based upon the diameters of the rack cutouts and the distance
between the detected surface and the bottom of the rack. Hanging containers that
do not rest on the bottom of the rack will introduce error to the volume
approximation if the container bottom level is not set to a new value. These types
of containers can only be used provided the new container bottom level is properly
set using Rack 2 setup (refer to Section 4.2 Instrument Setup).
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Flags (Continued)
Possible Insufficient Aspiration: (Continued)
Probe Insertion Depth:
For reagents, it is important to choose straight-walled bottles that snugly fit the rack
hole cut-outs. (Refer to Figure 9.1.1-1 Probe Insertion Depth Illustration.)
Sample volumes are usually so small that the vessel configuration is not a factor.
Reagent handling, however, can be adversely affected by significantly tapered or
under-sized vessels.
This is why: the probe detects the liquid surface at the start then ChemWell
calculates the proper insertion depth for the probe so that the probe tip will remain
just below the liquid surface when the aspiration is finished.
This calculation is based on the diameter of the rack hole cut-out, and it assumes a
straight-walled bottle. If a much smaller diameter bottle or a conical vessel is used,
the liquid surface will descend faster and could result in the aspiration of some air
and less than the desired reagent volume.
CAUTION: Pipette errors may occur if reagent bottles are used which have a
smaller diameter than that for which the rack was designed. This can result in
inaccurate volumes or no reagent being dispensed to some reaction wells.
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Flags (Continued)
Wash/Rinse Bottle Low:
When the wash or rinse bottle is low, you will be warned as appropriate.
The software will automatically check the status of the bottles when preparing to
run assays.
Refill the bottle(s) before starting the assays.
If one of the bottles becomes low during the run, the Error Status Board will
display a message Wash bottle empty or Rinse bottle empty and will
continue to perform the wash with the remaining solution.
To refill the wash bottle, select Pause Engine from the Management Menu.
Refill the wash bottle. Select Resume Engine from the Management Menu.
Waste Bottle Full:
When the waste bottle becomes full during a run the software will prompt
Waste Bottle Full.
If the message appears to be in error, wipe out the inside of the bottle cap with
a dry cloth. It is very important not to run the instrument when the Waste bottle
is full to avoid damage. The software does not check the drain waste container.
NOTE: Although the software only checks the Wash, Rinse, and Waste bottles
when necessary for assays, the instrument checks itself periodically. If the
instrument is beeping periodically during periods of inactivity, check the bottle
volume levels.
CAUTION: Do not open the WASTE bottle until the pressure is released.
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Solution:
Check command for spelling and validity.
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Error Code(s)/Problem:
Rack is jammed
(Continued)
Solution:
If normal operation does not resume after clearing the
obstruction, select Initialize from the Management tab
on the ChemWell Manager menu.
If the problem is not solved by re-initializing, make a
service report. Turn the instrument off and restart it. If
the jam has not cleared send the service report.
NOTE: The service report should be made BEFORE
restarting the software so that important information
will not be lost.
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Error Code(s)/Problem:
021 Small syringe stroke
error
022 Large syringe stroke
error
Solution:
Check the assay programs to make that the
maximum (2.5 mL max large syringe; 50 uL max
small syringe) has not been exceeded.
Select the Routines tab from the ChemWell Manager
menu, and click on the Wash Probe option to reset
the syringe position.
Figure 9.1.2-1
Possible causes include setting the washer depth too
low or setting it such that the wash head tubes hit the
edge of the reaction plate wells. (See Instrument Set
Up).
The Set Up should be re-checked so that the long
tubes of the wash head just lightly touch the
microwells and are set toward the back of the center
of the wells.
Make sure that the wash head appears level after
installation and that the screws are snug.
511 Wash movement error.
Wash aborted.
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Error Code(s)/Problem:
512 Waste bottle is full
Solution:
Pause the Engine by clicking on the Pause Engine
icon
. (Click on icon again when
finished to Resume Engine.)
Carefully unscrew the cap and empty the waste
bottle.
CAUTION: Protect yourself from contact with
hazardous waste.
Make sure the aerosol filter does not get wet in the
process (replace if this happens).
If the Waste bottle is already empty when the error
message is observed, check that the sensors are not
shorted by foam, or touching each other.
Clean the inside of the cap with a paper towel. Close
the cap tightly and assure that the colored luer locks
and sensor are plugged in before resuming operation.
icon.
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Error Code(s)/Problem:
515 Filter Wheel Error
Wheel is not rotating
516 Pressure System Error
Solution:
Check filter wheel pulleys for freedom of movement.
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Error Code(s)/Problem:
520 Y slot not detected
Solution:
Y Slot flag not properly situated. Physical
obstructions in path of Plate Y.
Malfunctioning Y slot sensor.
Look for all four lights and replace any burned out
bulbs. Always contact your Instrument Service
Provider first.
If all the lamps are lit, check for fluid spillage. Spillage
or an obstructed or damaged optical filter may also
cause this message due to decreased detection of
light.
Clean spills immediately and wipe chemical residue
away with repeat cleanings using fresh water.
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NOTES:
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Telephone:
USA 772-283-6540
Fax:
USA 772-283-8020
E-mail: chemwell-support@awaretech.com
Mailing Address:
Important: When contacting us, please have the Model and Serial Number of the
ChemWell in question. Have a description of the problem with as much detail as
possible. Save any relevant jobs or logs and send or e-mail us the information.
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12. APPENDICES
12.1 Appendix A - Reagent Cooling Accessory (RCA) - Optional
The Reagent Cooling Accessory (RCA) is an optional accessory for ChemWell.
The RCA protects reagents from high ambient temperatures.
Technical Specifications
Peltier thermoelectric modules cool the reagent rack via cold plates placed
internally in the ChemWell and connected to an external controller.
Allows complete freedom of rack movement during all functions of assay
operations, testing and sampling.
Overall
Requirements
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