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Module: Page:
i
ENVOY 500 – Operator Training Manual
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ENVOY 500 – Operator Training Manual
Learning Objectives-
At the conclusion of this training module, the user will be able to:
Activity 1-1
1. Your instructor will guide you through understanding the importance of
utilizing the Envoy 500 Operator Manual to efficiently and effectively
operate the Envoy 500 Chemistry System.
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ENVOY 500 – Operator Training Manual
Activity 1-2
1. Locate Section 1.3 of the Envoy 500 Operator Manual.
2. The instructor will identify the location, function and benefits of the
main hardware components on the Envoy 500 as found in the table
below:
Power Supply:
Main Power Switch Located on the back of the Envoy 500. This
switch activates the reagent refrigeration
system.
Power Switch for Computer Button located to the lower left of the monitor
which starts the computer and analyzer.
Working Areas:
Reagent Tray Refrigerated for optimal conservation and
reagent performance.
Five (5) easily removable Sectors (named
A-E) that have eight (8) positions each.
Reagent bottles - 90ml (R1) or 10ml (R2)
All Vital Diagnostics reagents are bar-
coded for ease of use – reagent name, lot
number, and expiration date are read from
the reagent barcode.
Expired reagents are recognized by the
system.
Reagents can be loaded while the Envoy is
running.
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ENVOY 500 – Operator Training Manual
Activity 1-3
1. Once located, apply the correct power-on sequence to your system.
Take notice of the normal starting up sequence.
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ENVOY 500 – Operator Training Manual
Activity 1-4
1. Locate and read Appendix A-3 in your Envoy 500 Operator Manual.
Password: _________________________
3. Create a New User with Level 0 (normal user) access. Note that if a
user is to have access to Patient Archives, it must be selected on this
screen.
4. User passwords expire three (3) months from the date created.
7. EXIT the Manage User window and log on using your new User Name
and Password. Notice that your Access Level is displayed in the
center of the Main Screen.
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ENVOY 500 – Operator Training Manual
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ENVOY 500 – Operator Training Manual
In this training module, the user will be introduced to the structure of the
main screen of the Envoy 500 User Software.
Learning Objectives-
At the conclusion of this training module, the user will:
Instruction – Overview of the Main Screen of the Envoy 500 User Software
The Envoy 500 analyzer software is Windows based and therefore uses
Windows style icons, quick commands, function keys and curtain-shaped
menus.
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ENVOY 500 – Operator Training Manual
NOTE: The side navigation bar can be removed from the main screen of
the Envoy 500 User Software; however this is not advisable as
most users tend to use a combination of all navigation methods to
reach desired submenus.
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ENVOY 500 – Operator Training Manual
The name of the corresponding submenu folder will appear when the
mouse is positioned over an icon.
NOTE: Direct Access icons can be removed from the main screen of the
Envoy 500 User Software; however this is not advisable as most
users tend to use a combination of all navigation methods to
reach desired submenus.
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ENVOY 500 – Operator Training Manual
The User Access level is located directly under the Program Code.
Access levels were discussed in Activity 1-5 of this Training Manual.
When the cursor rests on an F key icon, the F key that activates this menu
option will appear between brackets. Selecting this F key will perform the
same function as if the icon was selected. Example: “Analyzer (F5)”
means that the function key F5 has the same function of the icon.
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ENVOY 500 – Operator Training Manual
Message Log - A single click opens a window displaying date and time
stamped messages received by the program.
Alert Log - A single click opens a window displaying date and time
stamped alerts which occurred during the work session.
Date & Time - The system date and/or time can be edited by double-
clicking on this window. This will be necessary during
the spring and fall time changes.
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ENVOY 500 – Operator Training Manual
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Learning Objectives-
At the conclusion of this training module, the user will be able to:
Pour the entire contents of the Rinse Solution Concentrate into the
container. Vigorously rock the box to ensure thorough mixing. Write
the date on the box.
Once prepared, the working Rinse Solution is stable for two (2) weeks
at room temperature.
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ENVOY 500 – Operator Training Manual
CALIBRATION ANALOGY:
You are in need of a new bathroom scale so you go to Wal-Mart to buy
one.
Your laboratory is expanding or modernizing and has just
purchased a new Envoy 500.
You need a bathroom scale that will accurately weigh all the members
of your family, from your 7 year old to your big burley husband.
You need a chemistry instrument that will report accurate results on
your entire patient population.
After reviewing the available options, you choose a scale. For the
sake of this discussion, let us assume that the scale has not been
factory calibrated.
CLIA requires that laboratory tests performed on any automated
instrument be calibrated as per manufacturer’s guidelines.
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CONTROL ANALOGY:
Now you need to ensure that your newly calibrated scale will
accurately weigh your entire family from children to adults.
Now, you need to ensure that the wide range of test results that will
be run on the Envoy 500 are accurate.
You take your newly calibrated scale to the Pet Department where you
find 50 pound bags of dog food. You place one bag on the scale. If
the scale is properly calibrated this bag should weigh between 45 – 55
pounds. This would be your low control.
You program and run Envoy 500 Level 1 Control. All results must
fall within the assay ranges which are printed on the package insert
of the control.
You now place three 50 pound bags of dog food on the scale. Again, if
the scale is properly calibrated, the dog food should display a weight
between 145 – 155 pounds. This is your high control.
You program and run Envoy 500 Level 2 Control. All results must
fall within the assay ranges which are printed on the package insert
of the control.
After all of these checks, you can now ASSUME that this scale will
accurately weigh you, your child, and your husband.
After all of these checks, you can now ASSUME that the Envoy 500
will accurately result patient samples. All patient results are
ASSUMPTIONS. Operators have no idea what results to expect on
a patient. We can only ASSUME that if an instrument is
successfully calibrated and both levels of controls fall within the
expected assay range, that patient results will be accurate.
But could you use this scale to accurately weigh a package that weighs
approximately five (5) pounds? Could you use this scale to accurately
weigh anything greater than 400 pounds?
Of course not, because the scale has limits (reportable range) just as does
any test that is run on your new Envoy 500. In order to determine the
reportable range on any moderately complex laboratory instrument, CLIA
requires that reportable range studies be performed every six months on
every test that the instrument reports.
S
E
Volumetric pipettes are always marked with the letters TD (To Deliver).
This means that to dispense an accurate amount of what you are
measuring, the pipette must be allowed to drain into the container (To
Deliver the liquid). A small amount of liquid will always remain in the tip of
the pipette.
1. Press the A on the pipette bulb and squeeze the bulb section.
2. Insert bulb on the top of the volumetric pipette
3. Insert the tip of the volumetric pipette into a cup containing an aliquot
of reagent grade water. NOTE: To prevent possible contamination,
never insert a pipette directly into the container of reagent grade water.
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ENVOY 500 – Operator Training Manual
4. Press the S on pipette bulb and slowly draw the reagent grade water
into the pipette until water is above the measuring line.
5. Remove the tip of the pipette from the water and wipe dry.
6. Press the E on the pipette bulb until the meniscus (lowest most curve
of the water) rests upon the line on the pipette.
7. Move the pipette and bulb assembly to the control vial.
8. Press the E on the pipette bulb to dispense the liquid into the vial.
9. Carefully touch the side of the vial to remove any hanging drops. A
small amount of water will remain in the pipette – do not dispense this
into the vial.
Activity 3-2
Your instructor will demonstrate the proper way to measure reagent grade
water with a volumetric pipette.
1. Practice using the volumetric pipette and suction bulb until you feel
comfortable.
Activity 3-3 Calibrator, Control, & Reagent Packaging & Package Inserts
1. Your instructor will discuss the packaging of the Envoy 500 calibrators,
controls and reagents.
2. Compare the information contained in the individual package inserts to
the information listed on the Envoy 500 Reagent Preparation Guide.
3. Your instructor will discuss the importance of programming/verifying all
calibrator set points and control assay ranges in the Envoy 500 user
software. Actual programming will be performed in Module 13.
Under normal conditions, the Envoy 500 reagent tray must never be
moved while your instrument is ON (motors enabled). Your instructor
will show you how to disable and re-enable the Envoy 500 motors so
that that the reagent tray can be moved and all reagents can be
loaded.
1. _____________________
2. _____________________
1. _____________________
2. _____________________
2. Gently mix and date all reagent boats / bottles. Uncap all reagents
with the exception of ALP (Position #8) and CRE (Position #13) and
insert all reagent boats / bottles. To ensure quality results, Envoy 500
reagents must be inserted into the reagent tray in the following order:
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ENVOY 500 – Operator Training Manual
3. Open, date, and connect the External ISE Reference Solution to the
Reference Pump Tubing. This solution has a 30 day open stability.
4. Open and date all ISE (Special) Reagents. Insert each into its
assigned position on the ISE Reagent tray.
ISE Diluent and ISE Baseline must ‘breathe’ for 30 minutes prior to use.
Once opened, ISE Diluent and ISE Baseline are stable for seven (7)
days.
The ISE Conditioner is good until the expiration date on the label.
5. Your instructor will discuss the purpose, stability, use, and storage
requirements of the ISE Cleaner Solution (Pepsin).
Your instructor will show you the packaging of the Envoy Wash Solution
and discuss its purpose, function, and stability.
2. Reinsert the sample tray and reset the Envoy 500 using the
appropriate F Key button. This will clear the alert that was generated
earlier when you removed the sample tray and reset.
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ENVOY 500 – Operator Training Manual
Activity 3-10 Navigating through the View Volume Status (F10) Screen
The View Volume Status (Reagent Management) screen displays a
representation of 8+8 bottles contained in a single reagent sector.
The large boats are displayed on the lower position and the small bottles
are displayed on the upper positions. Both positions contain the reagent
test codes.
Above the Exit button, the field “Sector” appears. All reagents positioned
on the selected sector are visibly displayed; “A” is the default sector. To
select a different sector, click on the left and right hand buttons.
1. Navigate through the sectors on your Envoy using the left and right
hand buttons. Notice how the reagent positions move when different
sectors are selected (Sector A = Positions 1-8, Sector B = Positions 9-
16, etc.).
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ENVOY 500 – Operator Training Manual
D
B
B: Scan all bottles – The function of this button is exactly the same as that
performed in ‘Check volumes’ if reagent barcodes have been enabled.
C: Print - This function allows the user to print the current volume
information for all measured reagents.
NOTE: The External Reference Solution volume will not be displayed and
must be visually checked every morning. The approximate
volume of saline in the Sample Diluent container will also be
displayed. Sample Diluent is used when tests are selected for
“Rerun hyperactive” in the parameters section of each test.
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Volumes of all ISE Reagents will appear in milliliters directly under the
graphic volume display.
The Number of samples that display in the white boxes under the reagent
volumes indicates the maximum number of tests that can be performed by
the volume of that particular ISE reagent.
2. Select Functions > Shutdown and perform the End-of-Day ISE and
Cuvette wash.
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Learning Objectives-
At the conclusion of this section the user will be able to:
Upon its completion, and when the system has reach temperature stability
(temperature portion of the screen no longer flashing red), the user must
initiate a Zero Photometer (Zeroing on Water) cycle which checks the
integrity of the halogen lamp and cuvettes.
Activity 4-1
1. Perform Daily A.M. Maintenance as per Page 1 of the Daily
Operation Guide.
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ENVOY 500 – Operator Training Manual
7. Turn to Page 2 of the Daily Operation Log and navigate to the View
Volume Status screen of the software. Follow the instructions to
properly Remove Reagent Caps on your Envoy 500.
Activity 4-2
1. Following the instructions on Page 3 of the Daily Operation Guide, load
applicable calibrators into their assigned positions on the sample tray.
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ENVOY 500 – Operator Training Manual
3. Return to the Standards section of the Envoy User Software and select
the remaining tests that require calibration. When finished, select
RUN.
6. Your instructor will discuss the calibration results that appear on the
Specimen Log and assist you in repeating any calibrations that might
not have passed.
Activity 4-3
1. Following the instructions on Page 4 of the Daily Operation Guide, load
Level 1 and Level 2 controls into their assigned positions on the
sample tray.
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ENVOY 500 – Operator Training Manual
2. Your instructor will discuss the various ways to program Control runs,
depending upon whether your instrument is or is not interfaced to an
LIS or Middleware computer.
5. Your instructor will discuss the control results that appear on this log
and assist you in repeating any results that do not fall within the assay
range.
Activity 4-4
1. Following the instructions found in the Stand-Alone Envoy 500 (No
LIS) section on Page 6 of the Daily Operation Guide, order the
following two patients, load their samples, and start the run.
2. Your instructor will discuss INFO FLAGS that appear in the Specimen
Log and how each result of every sample should be checked for Info
Flags prior to releasing the report.
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ENVOY 500 – Operator Training Manual
Activity 4-5
1. Perform all procedures listed in the Reagent Management section.
2. Archive Data – your instructor will demonstrate the two sections of the
Envoy User software where the Specimen Log can be ARCHIVED.
Be aware that you must wait to run the sample until the system has
reached the proper operating temperature (temperature display no longer
flashing red).
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Learning Objectives-
At the conclusion of this section the user will be able to:
Test Create Test Test Routine/ Batch Standards Controls Utility Mechanical Specimen View View Shutdown
Directory Reagent Parameters Profiles STAT Testing Tools Calibrations Log Reaction Results
Tray Testing
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Activity 5-1
1. Navigate to Analyzer Set-Up on your Envoy 500.
2. Follow along with the instructor as the features and functions of this
menu option are briefly discussed.
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Learning Objectives-
At the conclusion of this section, the user will be able to:
Activity 6-1
1. Follow Pages 1 – 2 of the Envoy 500 Daily Operation Guide.
3. Upon their completion, your instructor will assist you in evaluating the
calibration results.
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ENVOY 500 – Operator Training Manual
6. Upon their completion, your instructor will assist you in evaluating the
control results.
7. If any controls fall outside of the assay limits, your instructor will
demonstrate the proper way in which to repeat it. If no controls have
fallen outside the assay limits, select one test to repeat anyway,
following the procedure on Page 5 (Re-Running ‘Out of Range’
Controls).
10. Record all Daily – A.M. maintenance on the Envoy Maintenance Log.
Activity 6-2
1. Program and start the following patients as per the Envoy 500 Daily
Operation Guide:
Chart Number: 05102001BS
Patient: Bart Simpson
Notes: Patient appears jaundiced
Tests Ordered: CMP
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ENVOY 500 – Operator Training Manual
3. While the samples are running, enter the following patient as a STAT
following the instructions on Page 6 of the Envoy 500 Daily Operation
Guide.
Chart Number: 1000
Patient: Speedy Gonzales
Provider: Dr. Zippy
Notes: STAT
Tests Ordered: GLU
4. While still on the order screen, select RUN. Notice how the sample
tray will move so that the sample can be inserted into STAT position 51
or 52. This sample will be given priority over the other samples
programmed on this Current Tray.
5. It has just been determined that Santa Claus needs a GLU added to
his recently completed Electrolyte panel. Follow the instructions on
Page 7 of the Daily Operation Guide - Adding Tests to a Patient
Sample and do so. Remember to START the test.
6. Wait until all results on Bart Simpson have been completed and it no
longer appears on the Current Tray list.
2. Insert the ISE Cleaner (Pepsin) and check Special (ISE) Reagent
volumes.
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6. Empty Waste.
9. Delete the Message and Alert Logs after reviewing their contents. Be
sure to Print any log that contains something that you do not
understand.
11. Record all Daily – P.M. maintenance on the Envoy Maintenance Log.
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ENVOY 500 – Operator Training Manual
In this module, the user will be introduced to the Data Handling Menu.
Learning Objectives-
At the conclusion of this section, the user will be able to:
There are four (4) additional programs within the Envoy 500 program.
One of these is Diagnostics which can be found in the FUNCTIONS folder
(where the user goes every morning to print their Zero Photometer
readings).
Activity 7-1
1. Navigate to Data Handling > Patient Archives.
2. Search for Bart Simpson’s report that was run earlier today and print
out a copy of his report.
Close Patient Archives and press F 7 (or click on the Key icon in
the F Key area on the center of the main screen).
Enter the secondary password for Level 1 access – BTADJUST –
and press the enter key.
Level 1 access should now be displayed on the Envoy main screen.
7. Select the Test Report command button. Your instructor will explain
this feature.
9. Your instructor will show you how to create a Monthly backup and
delete all result in the Patient Archives application.
10. Your instructor will demonstrate how to locate a patient report from the
Monthly backup that was just created.
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Select Print Preview > click on the printer icon on the top left >
click ‘OK’ to print.
Properly remove the thumb drive from the USB port.
11. Restore Patient Archives – Your instructor will discuss the automatic
daily backup performed by the Envoy 500 and have you restore your
system’s database. Note that the recovered database may not be
complete.
When a Specimen Log containing control results is archived, the last set
of results (bottom displayed sample on the Specimen Log) for each control
will enter the QC application. Repeated sample results that appear lower
on the Specimen Log will ‘over-write’ any result that appears above it on
the log. Controls that have test results in RED should be Rerun rather
than Reordered to prevent skewing statistics.
Activity 7-2
1. Navigate to Data Handling > Quality Control
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ENVOY 500 – Operator Training Manual
Data management
B C
E
F
G
(C) – Choose the display option of the data points – Daily or Total.
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(D) – Deselecting the ‘All data’ box when the <TOTAL> option is selected
allows the user to enter a date range for the displayed or printed
results or graphs. This option is used when printing LJ charts for the
CLIA required monthly director’s review.
Deselecting the ‘All Data’ box when the <DAILY> option is selected
allows the user to enter a particular date.
NOTE: The ‘To Time’ field always defaults to the current time,
therefore it may need to be expanded to 23:59 to include
results that were performed that day.
(E) – The Search button will initiate a search for stored QC results that fall
into the above qualifications.
Activity 7-3
Following the instructions found on Pages 9 and10 of the Daily Operation
Guide, perform the following tasks:
1. Print a Westgard Graph including only last month’s QC data for GLU
Level 1.
3. Print a Westgard Graph that includes ‘All data’ for BUN Level 2.
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Activity 7-4
Your instructor will introduce you to the DELETE menu found within the
QC Program. See Section 5.2.5 of the Envoy Operator Manual for more
detailed information.
This menu allows the user to delete old QC data via one of the following
methods:
By date
By analysis (test)
By method
By lot
Total
Activity 7-5
1. Navigate to Data Handling > Population
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In this module, the user will be introduced to the Envoy 500 ISE
Module. The ISE Module performs Sodium (Na+), Potassium (K+),
Chloride (Cl-) and Carbon Dioxide (CO2) on serum and urine samples
using Ion Selective Electrodes (ISE).
Learning Objectives –
At the conclusion of this section, the user will be able to:
Activity 8-1
1. Navigate to Tests > Test Parameters > Select ISE > Parameters
Your instructor will review the function of each setting.
2. Now select the Standards screen. Locate the area of this screen
where ISE calibrator set points are programmed.
3. Finally, select the Controls screen. Notice that this screen differs from
those of other tests in that each analyte (Na+, K+, Cl-, CO2) has their
own button which must be pressed to display its QC ranges.
Activity 8-2
1. Your instructor will have you order a Prime ISE Module cycle on an
Envoy through Functions > Utility Tools and then discuss the process,
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ENVOY 500 – Operator Training Manual
Activity 8-3
1. Your instructor will have you locate the Wash ISE Module cycle option
on an Envoy and discuss the process, step-by-step. Detailed
information on the Wash ISE Module cycle can be found in Section
6.1.6. of the Envoy Operator Manual.
The purpose of the Wash ISE Module cycle is to clean the electrode
stack by allowing the ISE Cleaner (Pepsin) to sit in contact with the
electrodes for a pre-determined length of time. The ISE Cleaning
solution is then flushed through the electrode stack by use of the ISE
Conditioner and ISE Baseline solutions.
A Prime ISE Module cycle will occur prior to Wash ISE Module cycle if
the ISE Module has been inactive for a predetermined length of time.
The “End prime ISE Module…!” message will display and remain
displayed for five (5) minutes while the Wash ISE Module cycle
continues.
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Activity 8-4
1. Your instructor will have you order an ISE Calibration on an Envoy and
discuss the process, step-by-step. Detailed information on the ISE
Calibration cycle can be found in Section 9.7.1 of the Envoy Operator
Manual.
In the case that the first ISE calibration attempt fails (red in the ISE
Slope section), the Envoy 500 will automatically perform the complete
calibration sequence a second time. If the second attempt also fails, a
third and final calibration sequence will be initiated. After three (3)
unsuccessful calibration attempts, the request will be aborted and
troubleshooting procedures should be initiated.
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Learning Objectives-
At the conclusion of this section, the user will be able to:
Activity 9-1
1. Daily Preventive Maintenance
Wash ISE Module Cycle – must be performed every day. This
cycle cleans the electrode stack using ISE Cleaner (Pepsin), ISE
Conditioning Solution and ISE Baseline Solution. To ensure that it
is performed, the user is prompted to run this cycle during either
Suspend Activity or Shutdown of the Envoy 500. The Wash ISE
Module cycle can also be initiated through Functions > Utility Tools.
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5. As Requested Maintenance
ISE Module Wash – At the completion of 150 ISE tests, the Envoy
500 will prompt the operator to perform a Wash ISE Module
through Functions > Utility Tools.
Cleaning the Chloride Electrode –At the completion of 300 ISE
tests, the Envoy 500 will prompt the operator to perform an
Electrode Cleaning of the Chloride Electrode.
6. As Required Maintenance
Manual Cleaning the Electrodes – The flushing and/or cleaning of
the electrodes are vital in removing clogs or protein build-up from
the electrodes. It is important to detach these electrodes from each
other to avoid possible accidental damage when handling.
Bleaching the Sodium Electrode – Under certain circumstances, the
inner core of the Sodium Electrode may become coated and
“bleaching” may be required to ensure quality results.
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If the Reference Pump tubing was replaced, five (5) “ISE Module
Prime” cycles are required to fill the tubing with ISE External Reference
Solution.
If the ISE module was removed without taking the Reference Pump
tubing off of its brackets, three (3) “ISE Module Prime” cycles are
required to re-fill the entire tubing with ISE External Reference
Solution.
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Learning Objectives-
At the conclusion of this section, the user will be able to:
1. Identify and state the function of all spare parts included with
the Envoy 500.
2. Recognize and perform all Daily AM Maintenance procedures.
3. Recognize and perform all Daily PM Maintenance procedures.
4. Recognize and perform all Weekly Maintenance procedures.
5. Recognize and perform all Monthly Maintenance procedures.
6. Recognize and perform all Quarterly Maintenance procedures.
7. Recognize and perform all Semi-annual Maintenance
procedures.
8. Recognize and perform all Annual Maintenance procedures.
9. Recognize and perform all As Needed Maintenance
procedures.
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The Maintenance Log displays a list of the Envoy 500 parts that require
routine replacement. Some parts are scheduled by time and others by
cycle. Not all the maintenance items or replacement parts are visible on
this screen. Photos of the replacement parts for each option can be
viewed by selecting the button to the left of the maintenance item.
When the life cycle limit or the replacement date has been reached, the
part (“Phase”) will appear highlighted in red. In addition, an onscreen
message at startup will state, “There are the following obligations in
diagnostic:”.
All functions, except Extra Wash Cuvettes can be reset by pressing the
corresponding button. The user must perform the Extra Wash Cuvettes
cycle through Functions > Utility Tool using a 5% bleach solution. Upon
the completion of the cycle, the ‘Replacement date’ will advance one
calendar week.
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ENVOY 500 – Operator Training Manual
1. Wash with water is the same Cuvette wash that is performed when
the Envoy initiates the SLEEP mode after sitting idle for 30 minutes.
Your installer will make a measuring device that can be used for the
easy preparation of this solution.
4. Dilutor Prime cycle primes Envoy 500 Rinse Solution through the
hydraulic system and through the Chemistry and ISE Arms at the
Wash Station.
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6. Wash ISE Module is the same ISE wash that can be performed when
selecting SUSPEND ACTIVITY or SHUTDOWN.
Reagent boat
Sample cup
ISE reagent station
Cuvettes
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10. F.C.C. calculation is used to calculate the optical correction factor for
the cuvettes. This utility is password protected and can be performed
by Vital Diagnostics Technical service personnel only.
12. Temperature Test stops the cuvette wheel from spinning every 14
seconds so that Vital Diagnostics service personnel can take the
cuvette temperature using a special thermometer.
13. Empty Fluidics completely empties the Cuvette Assembly and all the
fluidics. This procedure must be performed prior to replacing any parts
or tubing behind the drop down door or replacing parts or diluter tubing
in the ISE module compartment.
Both Sample Needles will be replaced as part of your annual P.M. visit.
However, in the case of clogs or damage, it may become necessary for
the user to remove or replace the sample needles.
Your instructor will show you how to remove the sample needles on
your Envoy 500. Detailed instructions can be found in Section 7.4.2 of
the Envoy Operator Manual.
2. Perform Extra Wash Cuvettes cycle – This cycle may have been
performed earlier in this Module.
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Learning Objectives-
At the conclusion of this section, the user will be able to:
Activity 11-1
Follow your Daily Operation Guide and complete the following:
1. Log-In
3. Pretend that you are running low on GLU reagent and have decided
that the reagent requires replacement. List all steps that are required
PRIOR to performing patient testing.
4. Calibrate ISE and GLU only – This simulates a normal operating day
when GLU was the only reagent that was replaced and no other
reagents have reached their calibration stability limit.
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7. Insert samples and start only the first four (4) patients.
10. When one sample is completed, repeat a single test through the
hidden Re-run work list.
11. Using the samples that have not been started, you will be shown how
to toggle patients between the Current Tray and the Extra Patients
work lists.
It is important to note that the printed patient sample report does not
contain the flag symbol, but instead uses an asterisk (*).
Under normal operating conditions, the user should get 5-7 Volume limit
alerts PRIOR to running out of any reagent (regular and ISE). If those
Volume limit alerts were not generated prior to reagent depletion, a
VOLUME CALIBRATION procedure should be performed through
Functions > Utility Tools (Refer to Module 10 of this Training Manual).
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Activity 11-2
To demonstrate Volume Limit alerts, a portion of your PRO reagent will be
removed.
1. Using the software, position PRO reagent on the reagent wheel to the
access arrow.
2. Remove the reagent from the reagent wheel and give it to your
instructor, who will remove and retain the majority of the reagent.
4. Begin testing and take note of the Volume limit alerts and what
happens when the reagent is totally depleted.
5. Open the View volume status window. Notice that left-clicking on the
reagent display shows the remaining tests highlighted in red.
Activity 11-3
1. Follow the instructions for END OF DAY found on Page 8 of the Daily
Operation Guide.
2. Put your system into Suspend Activity. Your return time is tomorrow at
8:00 am.
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Learning Objectives-
At the conclusion of this section, the user will be able to:
Activity 12-1
1. Follow Pages 1 – 2 of the Daily Operation Guide and perform normal
daily Start-up.
Activity 12-2
1. Your instructor will discuss basic chemistry troubleshooting techniques
utilizing the information found in Section 8.1 of the Envoy Operator
Manual.
Activity 12-3
1. Navigate to Data Handling in the TOP menu bar – (The Log Files
option is only available through the TOP menu bar).
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Learning Objectives-
At the conclusion of this section, the user will be able to:
Envoy HDL, LDL and ISE Calibrator lot numbers can change from box to
box. All set points (printed on the labels) must be verified when opening a
new box of calibrator.
Activity 13-1
1. Your instructor has changed some of the CALIBRATOR set points on
your Envoy 500. Using the Serum Calibrator package insert and the
instructions printed on Page 11 (Calibrator Set Point Modification) of
your Daily Operation Log, verify and correct all calibrator set points.
Activity 13-2
1. Your instructor has changed some of the CONTROL lot numbers and
assay ranges on your Envoy 500. Using the Serum Control package
insert and the instructions printed on Page 11 (Quality Control Range
Modification) of your Daily Operation Guide, verify and correct all
control lot numbers and assay ranges.
2. Notice that the CONTROL lot number is listed in parenthesis after the
control name (each level has a different lot number). This lot number
determines how the Control is identified in the Quality Control
application. When a new lot number is opened, the user must change
this lot number as well as the applicable range. Care must be taken to
ensure that all tests for each level are named exactly the same or they
will appear as a different control. The easiest way to do this is using
the copy and paste method for the control names.
3. After the new lot number of control has been put into use, data points
obtained on the old lot should be printed through the Quality Control
application and deleted. See Section 5.2 of the Envoy Operator
Manual or Activity 7-4 of this Training Manual for more detailed
information.
NOTE: This icon will not be visible if Analyzer Setup has been configured
to insert all new orders in the Extra Patients List.
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ENVOY 500 – Operator Training Manual
Activity 13-3
1. Program duplicate patients by using the Duplicate Patient icon on
Enter Patients screen. Order a GLU on 10 patients. Your instructor
will assist, if needed.
3. Remove the Rinse Solution line from its container to simulate an empty
box.
4. Start the run and move the sample cup from position to position after
each sampling.
5. Watch the level of the Rinse Solution in the reservoir. When the level
reaches the point where operation can no longer occur, the Envoy will
enter Standby mode with the number of tests in incubation clearly
stated on the window.
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ENVOY 500 – Operator Training Manual
7. If this was an actual run, the user would have to restart the work list to
continue testing (Options > Run > All).
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ENVOY 500 – Operator Training Manual
When the Re-run Pathological option has been selected, a new field
appears (Panic Range). Low and high test result limits for Man, Woman
and Child can be inserted. When saved, any result that falls outside of
this range will automatically be repeated and the repeated result will
appear on the Specimen Log. Only the repeated (second) result will print
on the final patient report.
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ENVOY 500 – Operator Training Manual
Activity 13-4
Read the information found in Appendix A-4 of the Envoy Operator
Manual. Your instructor will demonstrate the automatic dilution feature of
the Envoy 500 by using a sample that has an ALP result greater than the
programmed Test limit (Conc).
1. Insert Saline into the sample diluent container next to the ISE arm.
When the option is triggered, notice that the General Chemistry arm
aspirates and dispenses the reagent into the assigned cuvette and that
the ISE arm makes the actual dilution by aspirating the sample diluent and
sample, then dispensing the dilution into the cuvette that already contains
the reagent. Final results are already multiplied by the programmed
dilution factor and are ready to report.
Manual dilution
Report result as greater than the programmed Test Limit (example:
TRG > 750 mg/dL)
Sample sent to reference laboratory for further analysis
Activity 13-5
Your instructor will demonstrate a manual dilution by using a sample that
has a TRG result greater than the programmed Test Limit (Conc).
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ENVOY 500 – Operator Training Manual
2. When the Info Flag appears, your instructor will demonstrate how to
repeat the sample using a supplied manual dilution.
Activity 13-6
1. Program and run the following samples:
Chart Number: 007
Patient: James Bond
Tests Ordered: CRE, ISE
3. When Minnie Mouse is completed, repeat her ISE through Worklist >
Routine/STAT > Rerun.
Best used:
Worklist > Re-run
When only 1 or 2 tests require repetition
Analysis
Worklist >
When several or all tests require repetition (i.e.QNS)
Routine/STAT >Re-run
Activity 13-7
1. Navigate to Worklist > Routine/STAT > New Entry. Order another test
on ID 007 (James Bond).
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ENVOY 500 – Operator Training Manual
2. If the ID was entered exactly the same, a window will open asking if
the user wants to clone that sample ID. This feature allows the
operator to order multiple samples on the same patient (i.e. Glucose
Tolerance testing).
Activity 13-8
Your instructor will demonstrate how to program and run Calibration
Verification Studies on the Envoy 500.
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ENVOY 500 – Operator Training Manual
Some may apply to your account and some may not. It is advised that all
Technical Bulletins be saved in the back of the Envoy Operator Manual,
behind the appropriate tab.
Activity 13-9
Your instructor will distribute and discuss copies of all applicable Envoy
Technical Bulletins. These are the only copies that you will receive. Store
these in the back of your Envoy Operator Manual.
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ENVOY 500 – Operator Training Manual
With the purchase of your Envoy you are entitled to access their valuable
library of laboratory technical and billing bulletins (posted on-line) as well
as their ‘Ask the Experts’ program at no additional cost to you.
Activity 13-10
Your LIS manufacturer’s representative is responsible for supplying all
software updates, cables and connectors required to configure your Envoy
500 interface.
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ENVOY 500 – Operator Training Manual
Learning Objectives-
At the conclusion of this section the user will be able to:
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Chemistry Analyzers
Reagents & Controls
Hematology Analyzers
Immunoassay Analyzers
Laboratory Consulting
L7320, Rev. –