ChemWell T English

CHEMISTRY ANALYZER

MODEL 4600 SERIES OOPPEERRAATTOORRSS MMAANNUUAALL

Copyright Awareness Technology Inc. Doc. 4610 11/2012 Rev. A

TABLE OF CONTENTS

1. INTRODUCTION .................................................................................................................................... 1 1.1 INTENDED USE ...................................................................................................................................... 2 1.2 WARNING MARKINGS INSCRIPTIONS DAVERTISSEMENT ......................................................................... 2

1.2.1 Safety Symbols Le Symboles de Sret .......................................................................................... 2 1.2.2 Safety Terms Terminologie de Sret ............................................................................................ 3

1.3 SAFETY PRECAUTIONS........................................................................................................................... 5 1.4 OPERATING PRECAUTIONS .................................................................................................................... 7 1.5 QUICK START GUIDE............................................................................................................................. 8

2. INSTALLATION ................................................................................................................................... 18 2.1 UNPACKING THE INSTRUMENT ............................................................................................................ 18 2.2 SYRINGE INSTALLATION INSTRUCTIONS.............................................................................................. 23 2.3 INSTRUMENT SET-UP........................................................................................................................... 29 2.4 COMPUTER CONNECTIVITY AND SOFTWARE INSTALLATION ............................................................... 31 2.5 INSTRUMENT POWER UP AND CHECK OUT .......................................................................................... 35 2.6 INSTALLATION SETTINGS .................................................................................................................... 36

2.6.1 Settings - Software Options ......................................................................................................... 36 2.6.1.1 Database, Communication, Temperature ............................................................................................... 37 2.6.1.2 Test Running Strategy............................................................................................................................ 38 2.6.1.3 Report Appearance ................................................................................................................................ 40 2.6.1.4 Report Output ........................................................................................................................................ 41

2.6.2 Settings - Custom Report ............................................................................................................. 42 2.6.3 Settings - Select Language........................................................................................................... 44

2.7 PARTS AND CONTROLS ........................................................................................................................ 45 2.7.1 Instrument Exterior...................................................................................................................... 45 2.7.2 Instrument Front View................................................................................................................. 47 2.7.3 Cuvette Carrier............................................................................................................................ 48 2.7.4 Syringe......................................................................................................................................... 49 2.7.5 Universal Rack Assembly ............................................................................................................ 50

3. PRINCIPLES AND SPECIFICATIONS ............................................................................................. 51 3.1 CONTINUOUS LOADING ....................................................................................................................... 51 3.2 TECHNICAL SPECIFICATIONS ............................................................................................................... 52

4. CHEMWELL-T MANAGER................................................................................................................ 55 4.1 OPENING THE SOFTWARE .................................................................................................................... 55 4.2 ALIGNMENT SETUP/UTILITY MENU..................................................................................................... 55

4.2.1 Alignment Setup........................................................................................................................... 55 4.2.2 Self Test ....................................................................................................................................... 62 4.2.3 Filter Voltages ............................................................................................................................. 63 4.2.4 Firmware Update ........................................................................................................................ 64 4.2.5 Launch Assay Editor.................................................................................................................... 64 4.2.6 Launch Pack ................................................................................................................................ 65 4.2.7 Launch Report Creator................................................................................................................ 66

4.3 CHEMWELL-T MANAGER TABS .......................................................................................................... 67 4.3.1 Layout Tab................................................................................................................................... 67 4.3.2 Calibration Tab ........................................................................................................................... 69 4.3.3 Sample Tab .................................................................................................................................. 72 4.3.4 Test List Tab ................................................................................................................................ 74 4.3.5 Report Tab ................................................................................................................................... 76

4.4 MAIN MENU SELECTIONS AND FEATURES........................................................................................... 79 4.4.1 Management Menu ...................................................................................................................... 80

4.4.1.1 Laboratory Information System (LIS).................................................................................................... 82 4.4.2 Routines Menu ............................................................................................................................. 84 4.4.3 Lot # Registration ........................................................................................................................ 85 4.4.4 QC Tracking ................................................................................................................................ 85 4.4.5 Sample DB................................................................................................................................... 87 4.4.6 Settings ........................................................................................................................................ 87 4.4.7 Utilities ........................................................................................................................................ 87 4.4.8 View............................................................................................................................................. 88 4.4.9 Help ............................................................................................................................................. 88

4.4.9.1 About Info.............................................................................................................................................. 88 5. RUNNING CHEMWELL-T.................................................................................................................. 89

5.1 START OF DAY .................................................................................................................................... 89 5.1.1 Run Start of Day .......................................................................................................................... 89 5.1.2 Sample Database Setup ............................................................................................................... 90

5.1.2.1 Add Sample ID ...................................................................................................................................... 90 5.1.2.2 Modify Sample ID ................................................................................................................................. 92 5.1.2.3 Delete Sample ID................................................................................................................................... 92 5.1.2.4 View Log ............................................................................................................................................... 93 5.1.2.5 Import Patient Record ............................................................................................................................ 93 5.1.2.6 Export Patient Record ............................................................................................................................ 94 5.1.2.7 Search Patient Record ............................................................................................................................ 95 5.1.2.8 Choose Patient Record........................................................................................................................... 95

5.1.3 Calibrators and Controls............................................................................................................. 96 5.1.3.1 Lot # Registration .................................................................................................................................. 96 5.1.3.2 Concentration Range.............................................................................................................................. 97 5.1.3.3 New Curve and New Control................................................................................................................. 98 5.1.3.4 Calibration Event ................................................................................................................................. 101

5.2 RUNNING SAMPLES ........................................................................................................................... 102 5.3 END OF DAY ...................................................................................................................................... 103

6. ASSAY EDITOR .................................................................................................................................. 104 6.1 MAIN MENU AND TOOLBAR .............................................................................................................. 106

6.1.1 Assay.......................................................................................................................................... 106 6.1.2 View........................................................................................................................................... 106 6.1.3 Substances ................................................................................................................................. 107 6.1.4 Panels ........................................................................................................................................ 108 6.1.5 Indices ....................................................................................................................................... 110 6.1.6 Security ...................................................................................................................................... 112 6.1.7 Settings ...................................................................................................................................... 114 6.1.8 Assay Editor Help Menu............................................................................................................ 115 6.1.9 Icons .......................................................................................................................................... 116

6.2 CREATING NEW CHEMISTRY ASSAYS................................................................................................ 117 6.2.1 Assay Modes .............................................................................................................................. 118

6.3 ASSAY STEPS..................................................................................................................................... 124 6.3.1 Select Step.................................................................................................................................. 124

6.3.1.1 Add Sample ......................................................................................................................................... 125 6.3.1.2 Add Reagent ........................................................................................................................................ 128 6.3.1.3 Incubate (Lag Time) ............................................................................................................................ 131 6.3.1.4 Read..................................................................................................................................................... 131 6.3.1.5 Clean Probe.......................................................................................................................................... 135 6.3.1.6 Rinse Probe.......................................................................................................................................... 136

6.3.2 Edit Step..................................................................................................................................... 136 6.3.3 Order Steps................................................................................................................................ 136 6.3.4 Delete Step................................................................................................................................. 137 6.3.5 Copy Step................................................................................................................................... 137

6.4 INTERPRETATION SETTINGS............................................................................................................... 138 6.5 SPECIAL GROUPS ASSAY EDITOR ...................................................................................................... 140 6.6 STANDARDS....................................................................................................................................... 143 6.7 BLANK............................................................................................................................................... 146 6.8 CONTROLS......................................................................................................................................... 147

7. USER MAINTENANCE...................................................................................................................... 150 7.1 DAILY ROUTINE ................................................................................................................................ 150 7.2 WEEKLY ALCOHOL CLEANING.......................................................................................................... 150

8. LAUNCH REPORT CREATOR ........................................................................................................ 151 8.1 GETTING STARTED ............................................................................................................................ 155 8.2 REPORT CREATOR TOOLBAR ............................................................................................................. 156 8.3 GENERAL OBJECTS - FEATURES......................................................................................................... 157 8.4 GENERAL OBJECTS - PROPERTIES...................................................................................................... 159 8.5 CALIBRATION OBJECTS FEATURES ................................................................................................. 165 8.6 CALIBRATION OBJECTS PROPERTIES............................................................................................... 166 8.7 REPORT OBJECTS - FEATURES ........................................................................................................... 176 8.8 REPORT OBJECTS - PROPERTIES......................................................................................................... 176 8.9 LAYOUT............................................................................................................................................. 179 8.10 VIEW ............................................................................................................................................... 180 8.11 SAMPLE REPORTS............................................................................................................................ 181

9. TROUBLESHOOTING....................................................................................................................... 185 9.1 FLAGS AND ERROR MESSAGES .......................................................................................................... 185

9.1.1 Flags.......................................................................................................................................... 185 9.1.2 Error Messages ......................................................................................................................... 186

10. CONTACT INFORMATION ........................................................................................................... 192 11. APPENDIX A - INSTALLATION & VERIFICATION CODE .................................................... 193

11.1 CHEMWELL-T ADVANCED SOFTWARE............................................................................................ 193 11.2 EXTRACTION MODE - EXAMPLE ASSAYS......................................................................................... 194

11.2.1 Example Extraction Mode ....................................................................................................... 194 11.2.2 Extraction Mode Demo............................................................................................................ 194

12. APPENDIX B - RUN DIAZYME VITAMIN D ASSAY................................................................. 195 12.1 SETUP INSTRUCTIONS AND ASSAY PARAMETERS ............................................................................ 195

12.1.1 Instrument Setup (for any test) ................................................................................................ 195 12.1.2 Diazyme Kit Setup ................................................................................................................... 195

12.2 MATERIALS REQUIRED BUT NOT PROVIDED WITH KIT ..................................................................... 196 12.3 ADJUSTING PROBE HEIGHT SETTINGS FOR VITAMIN D ................................................................... 197

12.3.1 Probe vs. Rack Mover Alignment ............................................................................................ 197 12.3.2 Setting the Probe Height (Max Z)............................................................................................ 198 12.3.3 Verifying the Dilution Transfer Height.................................................................................... 199 12.3.4 Verifying the Extraction Mix Speed ......................................................................................... 201 12.3.5 Rack Dispense Heights ............................................................................................................ 201

12.4 ASSAY SETUP .................................................................................................................................. 201 12.5 AUTOMATIC PROCESS AND ASSAY TIMELINE.................................................................................. 204 12.6 ANALYZING RESULTS...................................................................................................................... 204 12.7 REPORTING OPTIONS ....................................................................................................................... 204

ChemWell-T Operators Manual Doc. 4610 Rev. A 1

1. INTRODUCTION

ChemWell-T is a computer controlled instrument system, capable of automating any or all stages of assay processing that involve these functions:

Fluid Handling - aspirates and dispenses from 2L to 400L Incubating - reaction cuvette to default 37C, or 25C or room temperature Mixing on-board oscillating probe (programmable speed) Timing - from 1 second to 24 hours Optical Reading - UV/visible range Calculating - uses numerous preprogrammed equations Data Storage - unlimited capacity Data Reporting - many options and customizations to choose from

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 and turbidimetric 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-T may also be used in production processes involving micro volume dispensing, diluting, incubating, and reading. ChemWell-T is a unique automatic biochemistry system. Reactions occur in standard plastic cuvettes instead of sample cups or a carousel. Cuvettes 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 cuvettes, incubate, mix, etc. ChemWell-T 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 rack and cuvettes, which reagents to use, how many controls to run, number of applications to be used, and so on. 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 biochemistries. Before applying any new clinical reagent system, first check with the diagnostic reagent manufacturer for specific instructions, validation information, and application tips.

2 ChemWell-T Operators Manual Doc. 4610 Rev. A

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-T instruments and software are tools developed for the modern global laboratory. The power and freedom to apply ChemWell-T is completely yours!

1.1 Intended Use

FOR IN-VITRO DIAGNOSTIC USE This instrument is designed for use in processing general chemistry and turbidimetric assays. It is a general purpose instrument intended to be used by trained laboratory professionals who are capable of selecting the appropriate features and options for each specific clinical application. Contact your companys instrument service provider to arrange for training.

1.2 Warning Markings Inscriptions davertissement

1.2.1 Safety Symbols Le Symboles de Sret Symbols that may appear on the product: Les symboles de sret peuvent apparaitre sur le produit:

WARNING Protective Ground CAUTION BIOHAZARD AVERTISSEMENT La Terre Electrique LATTENTION BIOHAZARD

Risk of Shock (Earth) Terminal Refer to Manual Risk of Infection

Risque de Choc Prise de Terre Se Rapportent Risque dinfection


1.2.2 Safety Terms Terminologie de Sret

These terms may appear on the product:

Les marques sur le produit:

DANGER

DANGER Le de marque: DANGER

indicates an injury immediately accessible as you read this marking

indique le risque immdiat de dommages (assessible tandis que vous lisez la marque)

WARNING

AVERTISSEMENT! Le de marque: WARNING

indicates an injury hazard not immediately accessible as you read this marking

indique quun risque de dommages qui nest pas immdiat alors vous lisent cette marque

CAUTION

LATTENTION Le de marque: CAUTION

indicates a hazard to property, including the product

indique un risque a la proprit comprenant ce produit

These terms may appear in this manual: Les marques dans loprateur manuel:

WARNING AVERTISSEMENT! Le de marque: WARNING

WARNING statements identify conditions or practices that could result in injury or loss of life. WARNING indicates an injury hazard not immediately accessible as you read this marking. Ces rapports identifient les conditions ou les pratiques qui pourraient avoir comme consquence les dommages ou les pertes humaines.

CAUTION LATTENTION Le de marque: CAUTION

CAUTION statements identify conditions or practices that could result in damage to this product or other property. Ces rapports identifient les conditions ou les pratiques qui pourraient avoir comme consquence les dommages a ce produit ou a toute autre proprit.

BIOHAZARD BIOHAZARDS are biological agents that can cause disease in humans. Lab workers handling potentially infectious materials must use universal precautions to reduce the risk of exposure to these agents.


Warning! Avertissement!

WARNING: If any materials are overturned during operation, immediately set the power switch to OFF (0). This material should be treated as potentially biohazardous. Appropriate cleanup and disposal of biohazardous waste should be used.

Avertissement! Lors du fonctionnement, si on renverse des matriaux, coupez immdiatement le courant. Placez le commutateur lectrique a AU LOIN(0). Traitez le matriel comme biohazardous, utilisant approprie nettoient et des mthodes de disposition.


1.3 Safety Precautions To assure operator safety and prolong the life of your instrument, carefully follow all instructions outlined below.

WARNING

The probe performs a self-clean periodically while the probe is idle. Keep hands away from the probe at all times when the instrument is ON (1) and the shield closed.

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.

Servicing There are no user-serviceable parts inside the instrument. Refer servicing to qualified service personnel. Use only factory-authorized parts. Failure to do so may void the warranty.

Wear Protective Apparel Many diagnostic assays utilize materials that are potential biohazards. Always wear protective apparel and eye protection while using this instrument. Always operate this instrument with the aerosol shield lowered.

Follow Operating Instructions Do not use this instrument in a manner not specified by the manual, or the protection provided by the instrument may be impaired.

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.

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.

Install as Directed Install the instrument on a sturdy, level surface capable of safely supporting the instruments weight (38lbs or 17 kg). The mounting surface should be free of vibrations. The instrument does not require fastening to the bench top.


Warning!

Warning! 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.

Provide Proper Ventilation Refer to the installation instructions for details on installing the product so it has proper ventilation. Recommended clearance around and above the instrument should be at least 10cm (4 inches). Keep underside of instrument clear for proper cooling of reagent rack.

Do Not Operate Without Protective Covers Do not operate this instrument with covers and panels removed.

Use Proper Fuse There are no user replaceable fuses in the Model 4610 instrument. Avoid Exposed Circuitry Do not touch exposed connections and components

when power is present.

Avoid Excessive Dust Do not operate in an area with excessive dust. Do Not Operate With Suspected Failures If you suspect there is damage to this

instrument, have it inspected by a qualified service person.

Do Not Operate in Wet/Damp Conditions Do Not Operate In An Explosive Atmosphere 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 all-purpose 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.

Ground Terminal


1.4 Operating Precautions WARNING: Insufficient RAM will adversely affect the performance of your instrument.

Therefore, if using Windows XP, Vista or 7, the minimum RAM required is 512MB.

Watch the instrument during "Start of Day" operation to ensure that the probe 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, 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 installed.

Do not operate the instrument if the probe is damaged.

CAUTION!

CAUTION! To avoid waste fluid from backing up into the instrument, ensure that the drain tube is positioned such that the waste fluid is allowed to flow and 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. Avoid allowing the drain tubing to sag which may trap water and stop the flow.


1.5 Quick Start Guide

PERFORM START OF DAY

From the Routines Menu select Start of Day. The routine will begin and display Completed Routine when finished. Press OK to close dialog box.

Start of Day Completed Routine

During the Start of Day routine, the sample handling system will be primed with deionized water, and the lamp will turn on. NOTE: Observe the fluid handling system and ensure there are no leaks or bubbles. Repeat Start of Day routine as needed to remove bubbles. Reference Section 5.1 Start of Day for more information.

CAUTION!

CAUTION! The Prime bottle water volume must be checked at Start of Day and periodically throughout the day. A low water volume will cause improper Probe washing and resulting in poor test results.

Step 1


Quick Start Guide (Continued)

ENTER CALIBRATORS IN LOT REGISTRATION

Select option Lot# Registration from the Menu Bar.

Choose a control or calibrator in the Substance field as prompted.

Click the Register button.

When the Lot # dialog box displays, you may optionally enter the Lot number or add a Note. Enter an expiration date by clicking on the date checkbox.

Step 2



(CONTINUED)

Enter the value of each concentration from the Calibrator Data Sheet into the Conc Range field.

Caution: Verify input before leaving each Lot number page. Data will not be changeable later. You will have to delete and re-register that Lot number to fix a historical mistake.

Step 2



CALIBRATION TAB

Select the Calibration Tab. Choose assay(s) from the drop down menu, and then click on Add calibration test information and select All. When All is selected, the curve and the controls are selected. Click on Reps to set number of replicates.

Calibration Tab

SAMPLE TAB

Click on the Sample Tab, click on Add Numerical ID and a dialog box will open for user to enter the first ID and total number of patients. Press Ok when done.

Step 3

Step 4

TABS



(CONTINUED)

When Sample IDs to run highlights, Select All check box is checked [A]

Choose test(s), click from list displayed [B]. Click on the Add Test button [C] and the Worklist is populated [D].

Sample Tab screen

LAYOUT TAB

When the rack is correctly loaded, press the Request [E] button which brings you to Layout Tab. If needed, use the drag and drop feature to relocate samples etc. in rack.

A

B

C

D

Step 4

TABS

Step 5

E



(CONTINUED)

Next, press the Start button.

Layout Tab screen

The Pre-run Check list will display reminding you to check that the prime bottle has sufficient amount of DI water, Reagent bottles and Sample vials are in the proper rack positions, and that empty cuvettes are in relevant positions. Press OK to proceed.

Pre-Run Checklist

Step 5

TABS



TEST LIST TAB

The Current Step, status and time remaining are shown.

A dialog box will display and the instrument will emit beeps to announce that the tests are complete. Press OK.

Step 6



(CONTINUED)

The Calibration Event window will open if Calibrators and/or Controls are run. Double click to go to Calibration Tab to check detail or close window.

Calibration Event window

Test List Tab

Click on Select All checkbox. Click on Accept NOTE: Results must be accepted to allow them to be viewed in Report Tab. Press OK to accept the selected tests at prompt.

Step 6

TABS



REPORT

Click on Report Tab choose the data you wish to print. Click on an individual test or click on the Select All checkbox.

Report Tab

Results may be sorted by Request Time, Name/ID, Test, or Interpretation.

Click on Print Preview button for a view of the output before printing.

Step 7

TABS



(CONTINUED)

Click on the Print button to print the selected results in Test Report format.

Step 7


2. INSTALLATION It is recommended that you read the Intended Use, Warning Markings, Safety Precautions, and Operating Precautions sections before setting up the ChemWell-T instrument.

ChemWell-T is carefully packaged in a custom-made container to assure its safe arrival. Upon receipt, if 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.

2.1 Unpacking the Instrument

Unpacking Instructions:

Cut and remove the bands securing the container:

Note: Please check the shipping documents for instructions to remove the instrument from the packing crate.


Unpacking Instructions: (Continued)


Open the container lid and take inventory of the contents: Cover, shield, tubing, universal rack and cuvette carrier; and the ChemWell-T instrument.

Carefully lift the ChemWell-T from the container and place it on a sturdy level surface capable of safely supporting the instruments weight (38lbs or 17kg). Remove the plastic wrap, and then remove the foam end caps while supporting the bottom of the instrument. Remove the plastic bag.

Cut the plastic ties securing the probe being careful not to bend the probe tip. Next, slide the Probe mechanism to the right.

Accessories

Carefully cut the plastic ties securing the probe

Plastic wrap

Foam end caps

Probe mechanism


Unpacking Instructions: (Continued)

Unpacking Instructions: Locate the 5/32 or 4mm hex wrench supplied in the spare parts kit that accompanies the ChemWell-T instrument and use it to remove the bolt securing the support bracket to the Probe X rail. Remove the support bracket.

The ChemWell-T is ready for set-up. Reference Instrument Set-Up section.

Locate the drain tubing supplied with the instrument. Note that the two plastic clips with adhesive backing may be applied to a surface to hold the tubing in place.

Install the drain tubing onto the end of the connector (A), at the rear of the instrument:

Drain tubing connector (A)

Remove the bolt securing the support bracket to the Probe X rail

IMPORTANT! REMOVE ORANGE

SUPPORT BRACKET!

R E M O V E

A


Unpacking Instructions (Continued)

Unpacking Instructions: Measure and cut tubing to the length of the drain tube connector to the edge of the surface (i.e. lab table). Install an end of the tubing to the connecting barb.

Select a container for waste. Measure and cut a length of tubing long enough to reach from the top edge of the surface to the top of the waste container. Note that the end of the tubing should be long enough to reach the top of the waste container without looping and the end of the drain tube should not rest in the waste fluid nor should it rest against the bottom of the waste container. Cutting the end of the tubing on a diagonal before placing it into the waste container will prevent the tubing from resting against the bottom of the waste container. To allow the waste fluid to drain into the waste container, place the waste container at a level lower than the threaded barb fitting connection. Connect the drain tubing to the barbed tee as shown.

Connect the drain tubing to the barbed tee as above (see A, B, and C). Push the tubing over the fitting as far as possible; ideally the edge of the tubing should be flush with the plastic nut. To allow the waste fluid to drain into the waste container, place the waste container at a level lower than the barb fitting connection. The waste drain tubing may be routed through an access hole on the lab bench to the waste drain container. The drain line may also be connected to an approved permanent drain.

A serves as air vent

B tubing

attached to the barb

C tubing

leading to waste container

A

C

B

A

B

12A9ZZ3A

Conn

To instrument

To drain

Up

Table edge


Unpacking Instructions (Continued)


Remove the backing from the back of the plastic clips to expose the adhesive, press each clip onto the surface and press the tubing into the clips to secure them to the surface.

Correct installation of barbs, tubing and clips

CAUTION! To avoid waste fluid from backing up into the instrument, ensure that the waste container is positioned at a level lower than the barb T fitting at the drain tube connection to allow the waste fluid to drain into the waste container.

Tubing installed incorrectly

INCORRECT CORRECT Measure and then cut the tubing to the desired length.

Tubing installed correctly

Clip Barb T Drain Tubing

Barb T Drain tubing Waste bottle


2.2 Syringe Installation Instructions Locate the box containing the syringe in the accessory box.

Syringe in packaging

CAUTION!

CAUTION! Avoid handling the syringe with bare hands!

Wear gloves when handling the syringe!

Open the syringe carton and with gloved hands remove the syringe components (glass barrel and plunger) from the carton.

Syringe


Remove the plunger from the plastic packaging.


Wet the tip of the plunger with isopropyl alcohol before inserting it into the glass barrel.

Insert the plunger into the glass barrel.


Syringe assembled and ready to install.

Install the tip of the syringe into the Luer fitting.


Press the plunger part of the syringe onto the dilutor arm.

Tighten the thumbscrew.


Syringe installed.


2.3 Instrument Set-Up

1. Fill the Prime bottle with fresh, clean de-ionized H20 and attach the cap. This step should be performed each day to avoid damage and prolong the life of components of the instrument.

Warning!


S

A B C A) Universal Rack B) Prime Bottle C) Cuvette Carrier

GROUND


Instrument Setup (Continued)

2. Install Universal rack by placing the rack over the rack locating pins. Insert the Cuvette carrier over the carrier locating pins.

Rack locating pins

Rack installed

Cuvette carrier installed


Instrument Set-Up (Continued)

Rear view of instrument

2.4 Computer Connectivity and Software Installation NOTE: DO NOT CONNECT THE USB CABLE TO THE PC UNTIL AFTER THE SOFTWARE IS INSTALLED!

1. Turn on the computer and insert the installation CD. The installer should automatically start, if not, select Run from the Windows Start Menu, run CD ROM drive:\setup, and follow the prompts for installing the program.

Click on the Next button.

A) USB cable connection B) Drain connection C) Power Cord connection D) Power switch

A B C D


Computer Connectivity and Software Installation (Continued)

Click on the Next button.

Click on the Install button.

The screen will display the progress of install.


Computer Connectivity and Software Installation (Continued)

Click on the Finish button.

2. Connect the power cord to the ChemWell-T instrument, then to an approved power source. Do not power on the ChemWell-T yet. It is strongly advised that a UPS (Uninterruptible Power Supply) be used to avoid power interruptions to the ChemWell-T and to the computer.

Warning!



Computer Connectivity and Software Installation (Continued) 3. The program default is to use AUTO for communication with the instrument. If

connecting the instrument to a different port, go to the Settings Menu and select Software Options. Select a communications port from the drop down menu and click OK.

Software Settings

The default temperature is 37C. This is the most commonly used temperature.

If the ChemWell-T has problems communicating with the computer, verify that the Silicon Labs CP210x USB to UART Bridge port number matches the port number set in the ChemWell-T software. The Silicon Labs port number can be found by using the Windows Device Manager as shown below:


2.5 Instrument Power Up and Check Out With the instrument connected to a computer, start the software, and power on the ChemWell-T. When the instrument powers up, note the following actions:

All racks move to the front (home) positions The probe moves to its home position (to the left), and then to the wash cup The syringe pump primes The instrument and the optical system lights come on

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 there is a problem with the communications setup. Check the USB cable connections and COM port settings.

The instrument will automatically connect to read more on this subject see Section 4.4.1 Management Menu.


2.6 Installation Settings When you first open the ChemWell-T Manager, there are several settings to choose from and a few tasks that must be performed before running samples.

2.6.1 Settings - Software Options Choose Software Options under the Settings menu.

Figure 2.6.1-1 Software Settings


2.6.1.1 Database, Communication, Temperature

OPTION DESCRIPTION

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. Setting choices are Room Temperature, 25 C, and 37 C (default).

Press OK when finished.

Make selections to set parameters for archive database, communication port settings, temperature settings, and sounds.

Note: Rack Cooling On is the default setting.


2.6.1.2 Test Running Strategy

Software Settings (Continued)

OPTION DESCRIPTION

Features allow greater control over how the tests are run and how the results are to be handled. These include:

Single predilute tube for duplicate samples.

Check reagent/control standard volumes

Show pre-run check list Start longer incubation

test first

Automatically retest sample if out of normal range

Avoid low temperature for kinetic tests when selected the tests will not start until the temperature is ready

If sample is low, skip the test and continue with others

Beep 60 seconds as a reminder. Click on check box to be notified when all tests are finished

Show calibration event dialog automatically

Set parameters for how to run the tests:


Test Running Strategy (Continued)


OPTION DESCRIPTION

Automatic or manual control of:

curve and control results

activating control results

activating control results

accepting sample results

printing sample report

Auto Accept Curve (default) The curve generated is automatically accepted.

Manual Accept Curve When tests are complete, they remain in the test list. The user can review the step log to see if there are timing errors, etc. The user should check the curve set and click the accept button. Curve records will be written into the database and displayed in the Calibration tab.

Manual Activate Curve After accepting curve, curve records go to the Calibration tab. They are available for the user to activate. After user activates a curve, Sample Results are calculated. This setting is helpful when a user chooses Auto Accept Sample and Auto Print Report.


2.6.1.3 Report Appearance


OPTION DESCRIPTION

Paper Orientation, Margin Settings

Print / Edit logo (see Figure A below)

Font, font size, font preview window

Space for notes, signature at end of the report

Specify your preferences on the report appearance.

Figure A


2.6.1.4 Report Output


OPTION DESCRIPTION

Specify settings, press OK when finished to save and exit.

To select a word from the list to appear in bold and capitalized on the output of the report, click on the word, press OK.

To add a new word to the list, type the word in the space provided and click on the Add into list button.

Specify optional data to print for different report types. You may also specify if report should be printed jointly.


2.6.2 Settings - Custom Report Choose Custom Report under the Settings menu.

Figure 2.6.2-1 Select Custom Report Option

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.

Figure 2.6.2-2 Custom Report Templates

A Result report templates

B

Assay mode calibration templates

C

Assay specific calibration templates


Three types of Custom Report Templates are available:

A Result Report Templates Result report templates are for custom reports that have been sorted by

request time, sorted by name/ID, or sorted by assay. B Assay Mode Calibration Templates Assay Mode reports are for custom reports that contain calibration data.

NOTE: Only Calibration objects can be used in these reports such as curve.

C Assay Specific Calibration Templates Choose a specific Assay to produce a report from this data. NOTE: Assay

Specific Calibration Templates override the Assay Mode Calibration Templates.

Click on the Set Template button to select a Custom Report template. Preview calibration reports via the Calibration Tab and preview button; preview sample reports via the Report Tab and preview button. Modify the example Custom Report and save it to a new file name.

Figure 2.6.2-3 Set Template Result

Custom Report templates are provided.

Modify and save under a new file name. Or create a new Custom Report using the Report Creator application. Reference the Launch Report Creator section for more on creating reports.


2.6.3 Settings - Select Language To change the language setting from the default, choose Select Language under the Settings menu.

Figure 2.6.3-1 List of available languages

A list of the available language choices will display. After selecting a language, it will be necessary to close the Manager and restart the software to initialize the selected language.

The selected language will remain in effect until another language is selected and the software is restarted as in the step above.


2.7 Parts and Controls

2.7.1 Instrument Exterior

Figure 2.7.1-1 Instrument Exterior

Figure 2.7.1-2 Syringe Shield align holes with pins to install

Top Shield Cover Base

Reagent (only) refrigeration via a self-enclosed Peltier cooling system

Align holes with pins


Instrument Exterior (Continued)

Figure 2.7.1-3a Instrument Exterior (rear view)

Figure 2.7.1-3b Instrument Exterior (bottom view)

Speaker Air Deflector Air Deflector

Photometer Fan

Ground Terminal USB Connection Drain Connection

Top (rear view) Power Connection Cover (rear view) Base (rear view) ON / OFF Switch

CAUTION! DO NOT BLOCK THE AREA UNDER THE INSTRUMENT!


2.7.2 Instrument Front View

Figure 2.7.2-1 Instrument Front View complete with shield

Figure 2.7.2-2 Refrigeration in reagent-area only and cuvette incubation pinpointed

Syringe shield 500l Syringe Cuvette carrier Cover Base

Top Shield

Universal Rack

Prime Bottle

Probe Tip

Cuvettes may incubate and be heated to 37.0C

Reagent refrigeration only in positions 1, 2 and 3 via the self-enclosed Peltier cooling system

1 2 3 4 5


2.7.3 Cuvette Carrier The Cuvette Carrier accommodates Express 550 Cuvettes. Cuvettes may incubate and be heated to 37.0C.

Figure 2.7.3-1 Cuvette Carrier

CAUTION!

CAUTION! Make sure the Cuvette Carrier and clean cuvettes are in place before starting any tests. Always select the Verify button before running an assay.


2.7.4 Syringe The size of the syringe used on the ChemWell-T is 500l and consists of a glass barrel and plunger (Figure 2.7.4-1).

When it is necessary to handle the syringe, do so with gloved hands only and carefully; if dropped the glass barrel may shatter (Figure 2.7.4-2).

Figure 2.7.4-1 Syringe installed on the Drive Arm

Figure 2.7.4-2 Syringe installation (reference Section 2.2 for more information)

CAUTION!

CAUTION! Avoid handling the syringe with bare hands! Wear gloves! Handle the syringe carefully; if dropped the glass barrel may shatter.

Luer fitting

Manifold

Syringe

Thumbscrew

Drive Arm

Syringe glass barrel

Syringe plunger


2.7.5 Universal Rack Assembly The Universal Rack assembly is made up of five sectors allowing the user to design a custom rack layout consisting of reagents, controls, calibrators, samples, samples in bottles, vials and a variety of tube sizes. Note that Sector E must be positioned in position 5 in order to accommodate primary blood collection tubes (reference Figure 2.7.5-1). The ChemWell-T Manager program allows the user to configure these sectors in any order (reference Section. 4.3.1 Layout Tab).

Sector Size/type

A 30ml bottle holder

B 15ml bottle holder

C Mixed bottle holder

D 2ml vial holder, also for 12 x 75mm tubes

E Primary tube sample holder will accommodate primary tubes 75mm or 100mm high

Figure 2.7.5-1 Example layout of the Universal Rack

A D

CB

E

Position 5

Position 4

Position 3

Position 2

Position 1


3. PRINCIPLES AND SPECIFICATIONS The ChemWell-T is a sample start system. This means that reagent is first dispensed, then samples start the reaction. The ChemWell-T is an automatic chemistry analyzer which can be programmed to use one or two reagents and make precise dilutions. On board is a syringe pump that can aspirate and dispense from 2l to 400l. The pump gets deionized H20 from the Prime bottle, with excess waste being drained through the Waste bottle. Teflon tubing connects the syringe pump to the stainless steel probe tip. The probe tip can be programmed to move up and down via the Probe Z motor. It can also be programmed to move left and right via the Probe X motor. In the middle is a Wash Cup where the probe tip can be programmed to Wash. The probe tip is equipped with a fluid sensing system which automatically stops the probe tip when it is submerged.

On the left hand side of the machine is a combined reagent and sample rack referred to as the Universal Rack (reference Section 2.7.5 Universal Rack Assembly). The Universal Rack is designed with holes to hold various sizes of reagent bottles and sample tubes/cups. On the left side of the platform, positions 1, 2 and 3 are refrigerated by a self-enclosed Peltier cooling system. The rack moves in and out through the programmable rack motor. Rack configurations are identified by the software, and are easily configured to the users needs. For convenience, racks can be pre-configured, taken out and stored in the refrigerator ready to load and use.

The cuvette carrier is designed to be easily taken out by the handle (reference Section 2.7.3.Cuvette Carrier). The cuvette carrier holds eight cuvettes; each cuvette can hold five separate reactions. The cuvette carrier can be taken out and cuvettes added or removed on the lab bench. The Express 550 cuvettes can be loaded only one way into the holder, with the teeth of the cuvette going towards the back. The cuvette moves in and out via the cuvette mover motor, which is fully programmable.

After reagent and sample are added, the cuvette may incubate and be automatically heated to 37 C or remain at ambient room temperature if required. The shuttle moves the cuvette from the cuvette carrier to the photometer. This is done automatically via the shuttle motor. When taking an optical reading, the cuvette is positioned in front of the single tungsten halogen lamp. The filter wheel with six filters (customizable to eight) rotates constantly in front of the cuvette. The ChemWell-T utilizes horizontal photometry in either single or bichromatic modes.

Depending on the setup, reports may be displayed or printed to create permanent lab records and physician reports.

3.1 Continuous Loading Continuous loading allows the addition of tests and samples on the fly while other tests are currently running instead of collecting a batch of specimens for a run. Calibrators and controls can be loaded at any time, allowing updating of stored curves or validation of tests when needed. If tests associated with the newly loaded Calibrators are already running, the Sample concentrations for those tests would be automatically adjusted for the new curves without any user intervention. Results for individual Samples can be accepted or re-run for verification, simply by clicking a button - it is no longer necessary to setup another job to re-run your samples.


3.2 Technical Specifications

Overall:

Maximum throughput Up to 100 end point reactions per hour or 75 kinetic reactions per hour

Typical reaction Volume 250L or more Dimensions 53cm Wide x 50cm Deep x 40cm High,

approximate weight < 15kg (37lbs)

Reagent and Sample Dispensing: Capabilities: Dilutions, predilutions, dispensing

single or multiple reagents

Pumps: Syringe pump, size: 500L

Probe: 316L stainless steel for maximum reagent compatibility, level sensing

Minimum and Maximum Volume: 2l 400l

Racks for reagents and samples Both reagent bottles and sample tubes are inserted into one rack. This includes five removable and user-selectable sectors to hold 15mL and 30mL bottles as well as typical blood collection tubes and serum vials. A portion of the rack is refrigerated.

Number of specimens: Typically 20 (including calibrators and controls) but variable depending on rack sectors selected.

Number of reagents: Customizable o Assorted replaceable racks and custom

designed rack segments are available for various bottle sizes.

Reaction vessel: Express 550 Cuvette Minimum reaction volume: 240l

Maximum reaction volume: 700l

Instrument bottles: 0.25L Priming Bottle (optional 0.5L bottle available)


Technical Specifications (Continued)

Incubation, timing and temperature control: Chemistries: Each cuvette is timed separately

Thermal control: Cuvette Carrier 37C or ambient room temperature o Refrigerated Reagent Rack cools 8 to

12 C below ambient through Peltier thermoelectric modules

o Reagent/Sample Racks may be temperature cooled if in correct sector and sector location is on rack base.

Reading: Optical design: Reads absorbance in one channel; NIST

traceable calibration; user selects monochromatic or bichromatic results

Light Source: Tungsten Halogen Lamp

8 position filter wheel: 340, 405, 505, 545, 580, 630 plus two empty positions in filter wheel for future use

Interference filters: Long life, hard coat, ion-assisted deposition, +/- 2nm, 10nm typical half band pass

Linear range: 0.0 to 3.0A

Photometric Accuracy: (1% of the reading +0.005A from 0 to 1.0A) (2% of the reading +0.005A from 1.0 to 3.0A)

Software: Format: USB and Internet upgrades

Operating Systems: Microsoft Windows XP, Vista, or Windows 7

Minimum System: Microsoft Windows XP 256 RAM; USB port

Secondary menu options: Create/edit protocols, import/export data, etc.,

Control, Run, and Setup


Technical Specifications (Continued) Calculation modes: Absorbance, single standard, factor, fixed time

kinetics, kinetics by standard or factor, multi-calibrator point-to-point, linear regressions, cubic spline, 4-parameter logistic and percent absorbance

Self monitoring modes: Reagent volume, filters, mechanical function, and more

QC options: Store control data, print Levey-Jennings or QC range plots, calculate SDs

USB port: USB cable provided

Power: AC Input 175 Watts Voltage Range: 100-250VAC Frequency Range: 50-60Hz Installation Category: CAT II

Environmental Conditions for Safe Operation: Indoor Use Mains supply voltage: Fluctuations not to exceed 10% of the

nominal voltage Altitude: Up to 2000 m Humidity: 80% for temperatures up to 31C decreasing

linearly to 50% humidity at 40C Temperature: 5C to 40C (See NOTE)

Recommended Environmental Conditions: Operating Temperature:.......................18-35C recommended

Operating Humidity: Less than 85% recommended

Certifications: NRTL listed, CE marked

Design and instrument specifications are subject to change without notice.

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.


4. CHEMWELL-T MANAGER

4.1 Opening the Software

The ChemWell-T instrument uses the standard Windows controls, windows, and dialogs. Refer to your Windows documentation to become familiar with these controls and how to use them.

Power on the instrument. Double-click on the ChemWell-T Manager icon to open the

ChemWell-T Manager software.

NOTE: It is not necessary to turn the instrument off when restarting the software.

4.2 Alignment Setup/Utility Menu

4.2.1 Alignment Setup Now that the ChemWell-T instrument is installed, the next step is to align the instrument and then you can run tests or jobs. Use the procedures in this section to ensure that the ChemWell-T instrument is ready to work.

Feature Display/Prompt Probe vs. Wash Cup

Select Probe vs. Wash Cup from the menu.

Press the button. The probe will move to the center wash position and lower into the cup. The probe tip should be centered in, and no deeper than the surface of the small, center wash cup. If it is not in position, use the arrow keys to move the probe into position. When finished, click Test to check new alignment. If aligned, click Save, then Close.


Alignment (Continued)

Feature Display/Prompt Probe vs. Wash Cup

Use the arrow buttons to position the probe correctly. The probe tip should be centered as shown:

To check new alignment, select Test. When finished click Save, then click Close. Probe vs. Rack Mover Under the Utilities menu, select Alignment. A list of options will display:

Select Probe vs. Rack Mover. Remove the rack when prompted, and then press OK to continue. The screen will display: To check the current alignment, click the probe down button:

Side-to-Side (blue) Up and Down (green)



Feature Display/Prompt Probe vs. Rack Mover Use the arrow buttons to position the probe correctly. The probe tip should be centered about 3mm above the rear pin, as shown:

To check new alignment, select Test. When finished click Save, then click Close. Probe vs. Cuvettes

Select Probe vs. Cuvettes from the menu.

Insert cuvette carrier with cuvettes at Row A and H when prompted. Use the arrows to align the probe tip as close as possible to the center of the cuvette and then align the probe tip to the bottom of cuvette. Next select double arrow up to align to the correct depth. To check the current alignment, click the probe button. Press Test to confirm. When finished, click Save and then the Close button.

Side-to-Side (blue) Up and Down (green)

Forward and Backward (red)



Feature Display/Prompt Photometer vs. Cuvette Carrier Select Photometer vs Cuvette Carrier from the menu.

Insert cuvette carrier with cuvettes at Row A and H when prompted. Use the arrows to align the cuvette carrier. Press the Test button. If the cuvette carrier is not in position, use the arrow keys to adjust. The cuvette carrier should slide in and out of photometer without sticking. When finished, click Test to check new alignment. If aligned, click Save, then Close.



Feature Display/Prompt Rack Dispense Height is used to select the dispense height when dispensing to a sample rack for pre-dilution purposes: Select Rack Dispense Height from the menu as shown:

Use the top set of three buttons to select the High dispense height, and the bottom set of three buttons to select the Low dispense height - the up and down arrows will adjust the probe up and down. Low is normally used for dispensing small volumes such as serum to a predilution. High is normally used for dispensing a large volume of diluent (these settings are specified when programming the assay in Assay Editor.). Low should be set inside the tube to eliminate splashing and loss of sample. High should be set as high as possible to thoroughly mix the sample/diluent, but not high enough to cause reagent foaming. Test with your particular reagents for appropriate dispense heights. Click on Save to save new settings, then Close.



Feature Display/Prompt Display Instrument Parameters: Select Display Instrument Parameters and Microsoft Notepad will open and display the instrument parameters.

Restore Instrument Parameters: Select Restore Instrument Parameters and a dialog box will open prompting for a serial number to restore parameters. Instrument parameters are restored from the parm.dat file.



Feature Display/Prompt Set Dirty Cuvette Cutoff Absorbance: Select Set Dirty Cuvette Cutoff Absorbance from the menu. A dialog box will open allowing the user to set the cutoff absorbance for dirty cuvettes. The user may read a tray of clean cuvettes (or if specific rows are to be read click on the Read checkbox for those rows see Figure 1) and the resulting absorbance reading may be used to set the range for clean vs dirty cuvettes. For example, if after reading clean cuvettes the absorbance reading is 0.12, then the Cutoff absorbance for clean cuvettes is 0.12. For this example the user would then set the Cutoff absorbance for dirty cuvettes to be >0.12. NOTE: Also reference the Layout Tab section for the function of the verify button. The verify button reads all cuvettes and marks missing or dirty cuvettes found prior to running an assay.

Figure 1


4.2.2 Self Test Self Test presents the user with the status of the instrument by recording data into the Self Test log in Notepad.

Press Start to execute Self Test, use Performance Check Kit P/N 046019.

CAUTION! Make sure that at least the first four cuvettes are in place and solution bottles are in the correct position in the Rack before clicking on the Start button.

Self Test will pipette and read repeats of three volume levels of a dye spanning the linear range of the photometer. The report will print out the results.

Check the %CV. All results should be less than 2%CV, except the 2l (small) sample should be less than 3%CV. If you encounter a higher %CV, or increasing %CV over time, it may indicate that cleaning is necessary.

Self Test creates a log in Notepad that can be printed out. Self Test performs an instrument test and provides a reading on the status of Pipetting, Accuracy, Photometer/Repeatability, Temperature, Blank Abs, Filter Volts, etc. NOTE: If standard filters are not installed, the instrument will select the most appropriate of the available filters.

The screen will track the progress of the test and display an information window with the status of the outcome of the test, either pass or fail.


4.2.3 Filter Voltages Select Filter Voltages from the Utilities menu.

Press the Test Current Voltages button to view the filter voltage readings of the channels at each of the six wavelengths. If filter voltage readings do not appear immediately, wait for the automatic lamp warm-up time. All voltages should be between 2.00 and 10.00. Lower readings might indicate that a lamp is misaligned or partially blocked. Consult your instrument service provider if correct voltages cannot be achieved.


4.2.4 Firmware Update Firmware update feature allows firmware to be updated. For service technician use.

4.2.5 Launch Assay Editor The Assay Editor will open when the Launch Assay Editor option is selected from the Utilities Menu. Refer to the Assay Editor in Section 6 for more information.


4.2.6 Launch Pack The Pack application is used by technical support to troubleshoot problems. Select the Utilities Menu, select Launch Pack

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.

An individual file may be selected by clicking in the check box next to the file name, or all files may be selected by clicking on the Select all checkbox.

The packed file will be located in the directory with the filename shown in the To display box on the screen.

The screen will display a message when the pack file operation has completed.

Click on OK.


Launch Pack (Continued)

A Microsoft Window will open and display the location of the pack file on your

computer. The pack file is beneficial to send to your support provider to help troubleshoot problems.

After sending the file, close the window.

Close out of the pack utility by pressing the Close button.

4.2.7 Launch Report Creator The Report Creator application allows users the opportunity to create unique formats for their reports. Reference Section 8 Launch Report Creator for an overview, instructions on how to get started and to view sample reports.


4.3 ChemWell-T Manager Tabs

4.3.1 Layout Tab The default window, which is open when the user starts the software, is called the Layout Tab.

Figure 4.3.1-1 Layout Tab

This window displays the current status of the instrument including the temperatures. Also shown are the currently loaded Reagent and Sample rack and cuvettes. The software automatically keeps track of which cuvettes in the reaction carrier have been used.

Feature: Description: Item No.:

Layout Tab The initial window that displays when the ChemWell-T Manager program is opened.

1

Home Use these buttons to return to the home positions. 2

Clear Reagents/Clear Samples

Press the Clear Reagents and Clear Samples buttons in Reagent/Sample Rack to clear all settings.

3

Verify Reads all cuvettes and marks missing or dirty cuvettes found.

4

Clear All Press the Clear All button in Cuvette Carrier to clear all settings.

5

1 2

3

54

TABS


Layout Tab (Continued)

The drag and drop feature allows the reagent and sample rack to be changed within sectors and between sectors as well.

The rack layout may be named and saved for future use. Confirm that the reagents or samples are in position and then click on Save.

The Save Rack Layout dialog box will open. Click on the drop down menu and you may choose a Rack1 Layout number from 1 to 30. A Name field is provided to name the rack layout.

Save Rack Layout


4.3.2 Calibration Tab

Figure 4.3.2-1 Calibration Tab


Choose Assay

Use the drop-down menu to choose one of the assays from the list.

1

Add Calibration Test Information

Lists the calibrators and controls by name, copies required, and whether or not they are valid.

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.

2

View Results

View the calibration and control results in this area.

3

1

2

3

45 6 7 8

9

TABS


Calibration Tab (Continued) Feature: Description: Item No.:

Work List Buttons

Click Save to save the current work list. Press the Load button to load a previously

saved work list.

Choose any or all of the items in the work list and click the Remove button to delete them from your work list.

Press the Request button to go to the Layout Tab to load and verify the locations of the reagents, calibrators, etc.

NOTE: Use the drag and drop feature to change reagent or sample locations within their sector locations and between sectors as well.

4

Activate Selected Button

To edit the curve, check the curve records (choose part of curve records which look good to user), then click the Activate Selected button.

This button will be enabled once the software calculates a valid curve.

After activating new curve records, the current curve is changed. The software will look at the test list to recalculate all finished tests of this assay.

5

Discard Recent

Upon accepting the new adjusted curve with the settings in Strategy Settings set to Auto, the option to discard recent is no longer available. (Reference Test Running Strategy in Section 2.6.1.2.)

However, if Strategy Settings remain defaulted to manual, the user has the option to discard recent and return to the previous curve.

With Strategy Settings set to manual, the new concentration values will display, however, the original values remain, allowing the user to Discard Recent.

6

Print Preview

Preview calibration and control results before printing statistics such as %CV, %Dif, and mean values are also shown.

7

Print Report Allows the user to print the selected assay. 8


Calibration Tab (Continued) Feature: Description: Item No.:

Curve Button

Toggles between substances selected (calibrators, controls) and calibration curves.

Curve Based on Selected records: - The curve based upon the calibrators selected in the Curve box. Select calibrators by clicking on the box to the left of the calibrator name.

Current Curve - When the desired calibrators have been selected (as shown above), click on the Activate Selected button to accept. The curve is displayed in the window. The current curve will then be used for sample calculations.

9


4.3.3 Sample Tab

4.3.3-1 Sample Tab

This tab can be used to set up a quick and easy work list.


Enter Sample IDs

Press the Add Numerical ID button to enter samples by number.

Press the Add Sample ID to choose a patient from the Sample Database.

1

Choose Tests

Click on one or more of the numeric/sample IDs on the left to highlight, choose a test to run with the chosen IDs. Click on the test and press Add Test.

2

1

2

3

4 5 6 7


Sample Tab (Continued)


Work List 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.

To add more copies to a test, utilize the Reps column.

If it is important to run a certain Patient IDs sample first, check the Urgent checkbox that corresponds with that Patient ID.

3

Remove button

To remove a Patient, click the row and press the Remove button.

4

Export button

Press the Export button to send the Work List to a text file in Notepad. Print the file from Notepad.

5

Calibrate button

Prepares calibration tests. 6

Request button

Press the Request button to open the Layout Tab. Verify the location of all samples, and press the All Are Loaded button when finished loading the rack. Verify the location of all samples.

NOTE: Use drag and drop feature to change reagent or sample locations within their rack location and between racks as well.

Press the Start button in the Layout window when finished loading the rack. The tests will now begin.

7


4.3.4 Test List Tab

Figure 4.3.4-1 Test List Tab


Layout Area Indicates the location of patient samples, reagents, and pertinent assays. For more information on a particular substance, highlight it with the mouse cursor. For example:

1

List Use the Highlight by Name/ID drop down menu to highlight a patient, or use Highlight by Assay drop down menu to highlight by type of assay. A list of all of the assays will display. The Current Step that is running displays to the right of the drop down menus.

2

Select All The Select All button selects all of the entries in the list. Items may also be selected individually.

3

1

2

3

4 5


Test List Tab (Continued) Feature: Description: Item No.:

Action buttons

Click Accept to accept the results of the selected ID.

Press Rerun to run the selected ID again.

Press Delete to discard the selected ID.

Choose Resume All to continue the tests.

NOTE: Results must be accepted to allow them to be viewed in the Report Tab.

4

Legend Used by Software

Used to identify the abbreviation codes used by the software.

5


4.3.5 Report Tab By default, the Report Tab shows the information from the most recent test run. However, by clicking on the History checkbox it is possible to search by date, Name/ID or test name and display those test results.

Results may be sorted by Request Time, Name/ID, Test, or Interpretation.

Select the Magnifying Glass Icon to view Kinetic Trend Data.


History Checkbox

Select the History checkbox to begin searching for results by date, Name/ID or test name.

1

Sorting Option

Select the Sorting Option from the drop down menu to change the way the results are displayed.

2

Magnifying Glass Icon

Select the Magnifying Glass Icon to view Kinetic Trend Data (Figure 4.3.5-1).

3

Figure 4.3.5-1 Kinetic Trend Data

1

2

3


Report Tab (Continued)


Search by Date

Use the drop down menus to select the dates to search for results.

1

By Name/ID Search for results for a specific Patient. 2

By Test Use this menu to search for results from a specific assay.

3

Select All Check this box to select all of the results. Only the selected results will appear in printouts.

4

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.

1

2

3

6 7 8 9 4 10 5


Report Tab (Continued) Feature: Description: Item No.:

Fold All Fold All narrows the display down to the selection made in the Sorting Options. For example, after sorting by Name/ID, click on the Fold All checkbox. The screen displays only the Name/ID column:

5

Print Preview

Select the Print Preview button, the report will display providing an advanced glance of what the output will look like:

6

Print Selecting the Print button will print the selected Results in report format.

7

Export Exports selected results to a text file (*.txt), MS Excel file (*.xls), or XML file (*.xml). Save for future reference.

8

Remove Selecting the Remove button will remove all selected items from the results display.

9

Retest (add to Sample Tab)

Adds the selected items to the Sample Tab to be re-tested.

10


4.4 Main Menu Selections and Features This section will introduce you to the items located in the ChemWell-T Managers main menu and toolbar icons. The toolbar icons shown below serve as shortcuts to some of the options on the main menu.

ChemWell-T Main Menu

1 2 3 4 5 6 7 8 9

Documents

ChemWell T English