Envoy 500 Operator Training Manual (L7320, Rev. - ) Low Res

OPERATOR TRAINING MANUAL
ENVOY 500 – Operator Training Manual
Table of Contents
Module: Page:
1. Introduction & Overview of the Envoy 500 1
2. Envoy 500 Software - Introduction 7
3. Envoy 500 Reagents and Solutions 13
4. Daily Operation - Session #1 25
5. Envoy 500 Software – Comprehensive 31
6. Daily Operation - Session #2 35
7. Data Handling Menu 39
8. ISE Module Operation 47
9. ISE Module Maintenance 51
10. Preventative Maintenance on the Envoy 500 55
11. Daily Operation Session #3 63
12. Basic Troubleshooting & Problem Solving 67
13. Advanced Daily Operation 69
14. Completion of Training 79
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Module1 INTRODUCTION AND OVERVIEW OF THE ENVOY 500

In this training module, you will be introduced to the Envoy 500 Automated
Chemistry System. The Envoy 500 is a random access, fully automated
multiprocessor controlled chemistry analyzer for in vitro testing. In
addition, the Envoy 500 contains an integrated Ion Selective Electrode
(ISE) module for the determination of Sodium (Na+), Potassium (K+),
Chloride (Cl-) and Carbon Dioxide (CO2).
Learning Objectives-
At the conclusion of this training module, the user will be able to:
1. Read, understand, and comfortably navigate through the Envoy

500 Operator Manual as part of routine work procedures.
2. Locate, identify, and describe the major Envoy 500 components.
3. Utilize the Manage User screen to create New Users, assign
appropriate Access Level, and allow access to Patient Archives.
Estimated Time to completion - 1 hour
Instruction – Operator Manual Navigation

Your instructor will present you with your Envoy 500 Operator Manual and
discuss the contents of each of its sections. This is your copy of the
Operator Manual. Throughout this training feel free to mark sections, take
notes and record your observations within your manual.
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.
2. Examine the organization of the Operator Manual by reviewing the

Table of Contents.
3. Navigate through each section as your instructor summarizes the

information.
Instruction – Envoy 500 Hardware Overview

Your instructor will identify and state the function and benefits of all the
main hardware components found on the Envoy 500 Chemistry System.
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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:
External System Components:

Integrated Computer Windows® based Operating System
Vacuum Pump Controls fluid movement within the Envoy 500
- moves Rinse Solution into the Envoy and
waste out. Utilizes a ‘Waste Full’ sensor that
generates an alarm when container is full.
UPS Battery Backup Conditions current and supplies 20 minutes of
power during outages.
Printer Color ink jet printer
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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Sample Tray  Divided into three (3) sections:

 1-52 programmable Routine/STAT
sample positions
 1-20 programmable Calibration
positions
 1-6 programmable Control positions
 STAT samples can be run any time.
 Flexible design allows for the use of sample
cups or any size of primary sample tube.
 Primary tube sensors automatically inform
the system of sample container (tube or
cup)
 Barcode capability eliminates incorrect
sample positioning.
Primary Chemistry Sample Arm  Accesses both reagents and samples
 Liquid level sensor
 Heated sample tube pre-heats refrigerated
reagents so that incubation time can begin
immediately after sampling.
ISE Sample Arm  Accesses both ISE reagents and samples
 Used mainly for ISE testing, but also used
for automatic dilutions and sample transfer.
 Liquid level sensor
 Heated sample tube
Probe Washing Sinks  Two probe washing sinks (one for each
sample arm). Peri-pump moves Rinse
Solution into the waste bowl to wash the
needle and heated tubing.
Cuvette Tray  Contains 34 re-usable glass cuvettes which
decrease costs both in consumables and
biohazard disposal
 Automatic washing station ensures that all
cuvettes are clean and dry prior to use
 Cuvette quality is monitored by system
Washing Station  Cuvette Washing Station – cleans and
dries cuvettes prior to use.
Halogen Lamp  Long lasting, easily replaceable halogen
light source
 Replaced by Vital Diagnostics trained
service personnel during annual PM
Diluters  Two diluters (one for each sample arm)
 Positive displacement diluters accurately
measure both sample and reagent volumes
 Requires no user maintenance
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ISE Module  Electrode Panel

 Performs Na+, K+, Cl- and CO2
 70 second cycle time
 Performs serum and/or urine samples
 30 ul sample volume
 1:14 automatic sample to diluent dilution
 Reagent Holder
 Holds ISE Baseline, ISE Diluent, ISE
Conditioner, and ISE Cleaner
 Approximately 200 tests can be
performed on 10 ml of ISE Diluent
3. Go to your assigned systems and locate the above components. Your

instructor is available to offer any assistance.
Instruction – Powering-On Your Envoy 500

Your instructor will help you locate the power switches on your Envoy 500.
Activity 1-3
1. Once located, apply the correct power-on sequence to your system.
Take notice of the normal starting up sequence.
2. After the Envoy 500 program loads, the Automatic Diagnostic

window will open. This feature verifies the function of some of the
Envoy 500 components.
Instruction – User Name and Password Management

Using Appendix A-3 in your Envoy 500 Operator Manual, your instructor
will help you program your User Name and Password.
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Activity 1-4
1. Locate and read Appendix A-3 in your Envoy 500 Operator Manual.
2. List the Password Administrator’s Operator (User) Name and

Password that is required to open the Manage User screen. The
Manage User screen must be opened to create or delete users. List it
below:
User Name: _________________________
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.
5. Using the information found in Appendix 3, complete this chart:
Password Level Function Secondary Password

Level 0 Normal Operator None
Level 1 Can modify results
Level 2 Access Test Parameters
Vital Diagnostics Service
Level 3
Personnel only
6. Create a New User with Level 1 access.
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.
8. The access level can be changed after Log On by selecting F7 or the

Change Access Level icon found in the center of the Main Screen.
Once open, enter the Secondary Password from the above table and
Enter to enter functions allowed by that password.
9. Change access level from Normal User to Level 2.
Instruction – System Warm Up

It takes the Envoy 500 approximately 10 minutes to reach a steady
temperature after being powered down. No instrumental functions should
be performed prior to that time. The system is ready to use when the
temperature bar at the bottom of the screen stops flashing red.
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Module 2 ENVOY 500 SOFTWARE INTRODUCTION
In this training module, the user will be introduced to the structure of the
main screen of the Envoy 500 User Software.
At the conclusion of this training module, the user will:
1. Understand how to minimize and maximize the Envoy 500 user

software.
2. Navigate through the Envoy 500 user software by using the top
menu bar.
3. Navigate through the Envoy 500 user software by using the side
navigation bar.
4. Navigate through the Envoy 500 user software by using the Direct
Access Icons.
5. Locate the current user software version and access level.
6. Locate and utilize F Key menu options
7. Manage the Message and Alert storage logs.
8. Monitor the reagent refrigeration unit operation and temperature.
9. Change system date and time.
10. Monitor room temperature, cuvette temperature, and system
vacuum.
Estimated Time to completion – 30 minutes
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.
Detailed descriptions and functions of items displayed on the Envoy’s

Main Screen can be found in Section 1.2 of the Envoy Operator Manual –
Explanation of Icons and Symbols.
Activity 2-1 Minimizing and Maximizing the Envoy Program

1. Go to your assigned system.
2. Minimize and maximize your system by pressing this button:
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Instruction – Top Menu Bar of the Envoy 500 User Software

The top menu bar allows access to all menus and submenus within the
Envoy User program.
Activity 2-2 Navigating through the Top Menu Bar

1. Open submenu options by clicking on one of the four folder names.
Each submenu option will be discussed in detail in Module 5 – Envoy
500 Software.
Instruction – Side Navigation Bar of the Envoy 500 User Software

Submenu options can be opened by clicking on one of the four folder
names. Submenus for WORKLIST, TESTS, and FUNCTIONS folders will
be identical to those in the top menu bar. Submenus for the DATA
HANDLING folder on this side navigation bar will have fewer options than
that displayed through the top menu bar.
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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Activity 2-3 Navigating through the Side Navigation Bar

1. Compare the submenu options displayed by selecting folders in the top
menu bar to those displayed by selecting folders in the side navigation
menu.
2. Circle the items above from the top menu bar options that are NOT
available in the Side Navigation Bar.
Instruction – Direct Access Icons

When a direct access icon is selected, the corresponding command is
directly activated.
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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Instruction – Current Version of Software & User Access Level

The current version of Envoy 500 software is listed as the Program Code
and is found in the center of the screen. Only the first five numbers are
significant to the user.
The User Access level is located directly under the Program Code.
Access levels were discussed in Activity 1-5 of this Training Manual.
Instruction – F Key Icons Location & Function

F Key icons are located in the center of the main Envoy 500 screen, to the
right of the Program Code and Access Level.
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.
Activity 2-4 F Key Functions

1. List the icon names, the F Key that activates it, and the functions of
this option in the chart below:
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Icon Icon Name F Key Function
Instruction – Bottom Status Bar

The bottom status bar contains several features, all of which will be
discussed in this section.
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.
Snowflake Icon - Displays the reagent refrigeration unit status. If the

reagent refrigeration unit is not working properly, there
will be a red hash mark through the snowflake.
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.
Temperature/Pressure - Ambient Temperature (RT), Cuvette

Temperature (CT), and Pump Pressure are displayed.
Double-clicking on this window opens a larger display.
Activity 2-5 Changing System Date and/or Time

1. Open the date and time display by double-clicking on it. The Envoy
500 utilizes the Windows date and time feature. Familiarize yourself
with this screen.
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Module 3 ENVOY 500 REAGENTS & SOLUTIONS

In this training module, your instructor will discuss the purpose and
function of calibrators and controls in the chemistry laboratory. Reportable
ranges will also be briefly discussed. An overview of reagent types and
their required preparation will be presented. Reagent tray programming
and reagent management through the software will also be discussed.
At the conclusion of this training module, the user will be able to:
1. Identify and prepare Envoy 500 Rinse Solution.

2. Recognize the functions that utilize Envoy 500 Rinse Solution.
3. Understand the purpose and function of calibrators and controls.
4. Demonstrate the proper use of a volumetric pipette.
5. Locate important information found on all package inserts.
6. Utilize the Reagent Prep Guide to properly prepare calibrators,
controls and reagents for use on the Envoy 500 system.
7. Navigate through the View Volume Status menu.
8. Assign reagent positions manually and/or via reagent barcode.
Estimated Time to completion – 1 hour 45 minutes
Instruction – Preparation and Installation of Rinse Solution

Envoy 500 Rinse Solution is used as a probe and cuvette rinse for the
Envoy 500 Chemistry Analyzer.
The Envoy Rinse Solution Concentrate contains surfactant and other

ingredients. The Rinse Solution box contains reagent grade water.
Activity 3-1 Rinse Solution Preparation

1. Observe while your instructor demonstrates the proper preparation and
installation of the Envoy 500 Rinse Solution.
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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Instruction – Calibrators, Controls and Reportable Ranges

If required, your instructor will lead a discussion to illustrate the function,
purpose and limitations of calibrators and controls when used in the
clinical chemistry laboratory.
WHAT ARE CALIBRATORS & CONTROLS?

There are many interchangeable terms used in the laboratory. In this
instance the terms calibrators, standards, and set points all refer to the
calibration process.
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.
 You take your new scale to the Exercise Department at Wal-Mart in

order to calibrate it. You find a certified 100 pound weight and place it
on the scale. You adjust the weight display on your new scale so that
it reads exactly 100 pounds. The scale is now calibrated.
You calibrate your new Envoy 500 by inserting the appropriate
chemistry calibrator solution into the assigned position on the
sample tray. Using the calibrator’s package insert, you review the
calibrator set points for all of the analytes that are contained in that
calibrator. Each test will have a different set point (its own specific
100 pound weight). You program the calibrator set point for each
test requiring calibration and run. When successfully completed,
the test(s) on the Envoy have been calibrated.
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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.
Another way to ensure that accurate results are reported is to

carefully review all results for error flags and watch for any results
that do not fit a pattern. Any test result that exceeds the laboratory’s
guidelines for repetition or just do not look right, should be
repeated.
WHAT IF A CONTROL DOESN’T WORK?

What happens if the single 50 pound bag of dog food only weighs 40
pounds? Or what if the three 50 pound bags of dog food weigh 160
pounds? Most probably you would first try weighing a different bag of dog
food in case there was something wrong with the first one. If the second
bag still did not weigh accurately, you would most probably return to the
Exercise Department and recalibrate the scale.
As with the dog food, if controls do not return results that fall within
the assay range, the operator usually repeats that control one time.
If it still does not work that test, like the scale, must be recalibrated.
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REPORTABLE RANGE ANALOGY:

Now you have a brand new bathroom scale, which you can now
reasonably assume will accurately weigh your entire family.
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.
Instruction – Volumetric Pipettes

Class A Volumetric Pipettes are one of the most accurate devices used to
measure liquids in the laboratory. Vital Diagnostics requires the use of
volumetric pipettes when reconstituting Envoy Controls, HDL and LDL
calibrators.
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.
Proper Use of a Volumetric 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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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.
Instruction – Preparation of Envoy Reagents, Calibrators & Controls

Your instructor will emphasize the importance of reading all package
inserts and will discuss the important information that can be found on
them. Use the Envoy 500 Reagent Preparation Guide to properly prepare
all calibrator, controls and reagents used on the Envoy 500 Chemistry
System.
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.
Activity 3-4 Calibrator Preparation

1. Your instructor will demonstrate how to properly prepare all calibrators
required for your training class, utilizing the 1 ml volumetric pipette, as
necessary, for HDL and LDL calibrator reconstitution.
2. Prepare the necessary calibrators and discuss their stability and
storage.
Activity 3-5 Control Preparation

1. Your instructor will demonstrate how to properly prepare Level 1 and
Level 2 Controls utilizing a 5ml volumetric pipette.
2. Reconstitute Level 1 and Level 2 Controls.
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Activity 3-6 Reagent Preparation

Envoy 500 reagent package inserts state that all reagents must be
allowed to equilibrate to the instrument temperature for a minimum of 30
minutes prior to use.
Using the Envoy 500 Reagent Preparation Guide:
1. Properly prepare all reagents provided by your instructor that will be

run on your Envoy 500.
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.
Disabling Envoy Motors:
1. _____________________
2. _____________________
Re-enabling Envoy Motors:
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:
Position Reagent Position Reagent

1 (Open) 9 ALT
2 TBIL 10 (Open)
3 DBIL 11 GLU
4 CAL 12 BUN
5 PRO 13 *CRE
6 ALB 14 TRG
7 AST 15 CHO
8 *ALP 16 HDL
* These reagents must be capped at night to prolong on-board stability
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Your instrument installer will correctly insert any additional reagents

that your laboratory may be running.
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).
Prepare ISE Cleaner Solution (Pepsin) according to the instructions

found on the Envoy 500 Reagent Preparation Guide or the cleaner’s
package insert.
The ISE Cleaning Solution is stable for 14 days when refrigerated.
Always allow the ISE Cleaner Solution (Pepsin) to reach room

temperature prior to use. It is an enzyme solution and as such, works
better when at room temperature.
Activity 3-7 Envoy 500 On-board Wash Solution

The Envoy 500 utilizes a dedicated reagent position (#40) for its Washing
Solution. The Envoy 500 Washing Solution is used at the end of every
day to thoroughly clean your reusable cuvettes in preparation for the next
working day.
Your instructor will show you the packaging of the Envoy Wash Solution
and discuss its purpose, function, and stability.
1. Insert a boat of Envoy Wash Solution into reagent position # 40.
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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Instruction – Reagent Tray Programming

The Envoy 500 Reagent Tray can be programmed:
 Manually via the Create Reagent Tray option (or)
 Automatically via scanning the reagent barcodes
Activity 3-8 Manually Assign Reagent Positions

Navigate to Tests > Create Reagent Tray and manually assign reagent
positions to some of the on-board reagents following the directions given
by your instructor.
Activity 3-9 Automatically Assign Reagent Position

Follow your instructor’s directions and scan the reagent barcodes in each
reagent sector.
Instruction – Reagent Management

Following the Reagent Management section (Page 2) of your Envoy 500
Daily Operation Guide, your instructor will guide you through the various
functions and features of this part of the user software.
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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D
B
A: Check volumes – Selecting this function will automatically scan ALL

tray positions and correctly identify the reagent bottles that are present.
The volume contained in each bottle will then be measured and updated.
This function will also measure and update the volumes contained in the
Special Reagents (ISE).
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.
D: Special Reagents - This function displays the approximate volume of

the ISE reagents: ISE Baseline, ISE Diluent, ISE Conditioner, and ISE
Cleaner.
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.
Activity 3-11 Inserting & Removing Reagent Bottles / Sectors

There are two ways to insert or remove reagent bottles in the reagent tray:
singularly or as a whole sector:
Replacing a Single Reagent – Right-click on the selected REAGENT

display. Select the appropriate option:
 Insert bottle – this option will position the selected REAGENT to the
arrow on the cover. Once acknowledged, this option will scan the
barcoded reagent label and measure the volume of the reagent(s).
‘Insert’ MEASURES a reagent’s volume.
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 Remove bottle – this option also positions the selected REAGENT

to the arrow on the cover. When acknowledged, this option will
scan the barcoded reagent label and remove that reagent’s graphic
volume display.
‘Remove’ DOES NOT MEASURE a reagent’s volume.
Replacing an Entire Sector – Right-click on the selected SECTOR that

requires removal or insertion.
 Insert sector – this option will position the selected SECTOR for
easy insertion. Once acknowledged, this option will scan all bar-
coded reagent labels that are inserted in that sector and measure
the volumes of all the reagents.
‘Insert’ MEASURES the reagents’ volume.
 Remove sector – this option also positions the selected SECTOR to
the arrow on the cover. When acknowledged, this option will scan
all barcoded reagent labels and remove those reagents’ graphic
volume displays.
‘Remove’ DOES NOT MEASURE the reagents’ volume.
1. Practice Inserting and Removing individual reagents and entire sectors

until you feel comfortable with both functions.
Activity 3-12 Removing Reagent Caps

Alkaline Phosphatase (ALP) and Creatinine (CRE) require that both R1
and R2 be capped at night to prolong on-board stability. To prevent
sample probe crashes, these four (4) caps require removal before testing
begins.
1. Follow the step-by-step instructions in the REMOVE REAGENT CAPS
section found on Page 2 of the Envoy 500 Daily Operation Guide.
Right click on unassigned Position #10 and select REMOVE to enable
access to both reagents.
Activity 3-13 Viewing Reagent Volume

1. Single left-click on a reagent graphic (R1 or R2) to display the following
window:
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Analyses: Name of the test

Volume (mL): Approximate volume in milliliters contained in the
selected reagent bottle
No. Samples: Approximate number of tests possible with the current
measured reagent volume
Max. Samples: Approximate number of tests which can be performed
when both reagents are used
2. Perform this function on several reagent displays. Notice that some

reagent boats are overfilled to ensure on-board stability claims. The
overfilled amount is not included in the cost of the reagent.
Activity 3-14 View Special Reagent (ISE) Volumes

Special Reagents always refer to the ISE reagents that are located in the
ISE reagent tray (right side of the Envoy 500) along with the Sample
Diluent.
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.
The Number of samples displayed under the ISE Diluent solution is

accurate; however, the Number of samples displayed under the ISE
Baseline solution is dependent upon how the system is operated. ISE
Baseline is used every time the Envoy 500 starts, stops, or primes. If one
sample at a time is run on a system causing it to continually start and stop,
the displayed Number of samples for the ISE Baseline will be inaccurate.
1. Follow the instructions found on Page 2 of the Envoy 500 Daily

Operation Guide to check volumes of the Special Reagents.
2. Select Functions > Shutdown and perform the End-of-Day ISE and
Cuvette wash.
23
24
Module 4 DAILY OPERATION SESSION # 1
In this training module, the user will be introduced to normal daily

operation of the Envoy 500 Chemistry System.
At the conclusion of this section the user will be able to:
1. Perform daily morning function checks on the Envoy 500.

2. Understand the purpose, function, and frequency of all required
morning function checks.
3. Distinguish the difference between result logs on the Envoy 500.
4. Calibrate tests and evaluate calibration results.
5. Control tests and evaluate control results.
6. Program and run samples.
7. Perform ‘End of Day’ procedures on the Envoy 500.
8. Understand the purpose, function, and frequency of all required
End of Day procedures.
9. Recognize the difference between Sleep Mode, Suspend Activity,
and Shutdown on the Envoy 500.
Estimated Time to completion – 1 hour and 45 minutes
Instruction – Envoy 500 Start-Up

Following the Envoy 500 Daily Operation Guide, your instructor will walk
you through all Start-Up functions and system checks.
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.
2. Document Performed Maintenance on the Envoy 500 Maintenance

Log.
3. System Log-On and Startup:

a. Any time that the system had been powered down (Shutdown
Mode), the Auto-Diagnostic check will be performed. Upon its
completion, the user will be prompted to Log-On using their
previously programmed user name and password.
25
b. If the system is on (Suspended Activity Mode), the user will be

prompted to Log-On using their previously programmed user
name and password.
4. Zeroing Photometer must be performed and the cuvette reading that

it generates must be printed and stored every working day. An
automatic reminder appears 24 hours after the last Zero Photometer
cycle was performed.
5. Message: ‘Standards to Run, PERFORM?’ message may appear on

your system. This is just a reminder that it has been longer than four
(4) hours since the ISE module has been calibrated. Always click NO.
6. Print Cuvette Readings must be performed and the generated report

must be stored with the daily calibration and QC logs.
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.
8. View Reagent Volumes by single left-clicking on any reagent graphics

whose volume appears to be low to ensure that there is enough of
every reagent to complete the days testing.
NOTE: Preferably low reagents are replaced at the End of Day to

ensure that all fresh reagents have time to equilibrate.
9. View Special Reagent (ISE) Volumes by selecting Check Volumes in

this Special Reagents window. ISE Cleaner, ISE Conditioner, and ISE
Baseline solution are used during the End of Day ISE cleaning.
Checking Volumes of Special Reagents before you start running in the
morning ensures that the most up-to-date ISE Baseline reagent
volume will be displayed.
Instruction – Calibration / Standardization

Your instructor will assist you in performing a full calibration run on your
Envoy 500 chemistry analyzer. Upon completion, your instructor will
provide important information on how to evaluate the calibration results.
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.
26
2. Navigate to the Standards section of the Envoy User Software and

select the Timed Standards button. Select ISE (should be the only test
that is selectable) and select RUN.
By running your ISE calibrations as timed, you will get a reminder

‘Standards to Run, PERFORM?’ when four (4) hours has passed since
the last ISE calibration.
3. Return to the Standards section of the Envoy User Software and select
the remaining tests that require calibration. When finished, select
RUN.
4. Turn to Page 4 of the Daily Operation Guide. Following the

instructions navigate to the Specimen Log and wait for calibration
results to appear.
5. Result Logs can be accessed by clicking on one of the Direct Access

Icons that resemble a sheet of paper. While your Envoy is running,
your instructor will discuss the features and functions of the two Result
Logs that are available on this system.
a. Specimen Log
o View results for sample
o View results for tests
o View results for standards
o View results for controls
b. View Results Log
Additional information pertaining to the Specimen Log and View

Results Log can be found in Section 3.2 – 3.3 of the Envoy Operator
Manual.
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.
Instruction – Quality Control

Your instructor will assist you in performing a full control run on your
Envoy 500 chemistry analyzer. Upon completion, your instructor will
provide important information on how to evaluate the control results.
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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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.
3. Using the instructions found in the Running Q.C. on a Stand-Alone

(Non-Interfaced) Envoy 500 section, order controls and start the run.
4. Turn to Page 5 of the Daily Operation Guide. Following the

instructions navigate to the Specimen Log and wait for control results
to appear.
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.
Instruction – Analyzing Samples

Your instructor will assist you in ordering and running two (2) patients on
your Envoy 500 chemistry analyzer.
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.
 Chart Number: 12345

Patient: Wylie Coyote
Provider: Dr. Roadrunner
Tests Ordered: BMP
 Chart Number: 8500-15

Patient: Donald Duck
Provider: Dr. M. Mouse
Tests Ordered: Creatinine and ISE
Upon their completion, sample reports will automatically be printed (if

the system is configured to do so through Functions > Analyzer Setup).
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.
Instruction – End of Day

Following the instructions found on Page 8 of the Daily Operation Guide,
your instructor will assist you in performing all End of Day procedures.
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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.
3. Backup Patient Archives as per your instructors directions.
4. Delete the Message and Alerts Logs
5. Perform Suspend Activity with Cuvette and ISE Wash – Your

instructor will explain the difference between SUSPEND ACTIVITY and
SHUTDOWN. Program your system to wake up tomorrow at 8:00 am.
6. Document Performed Maintenance on the Envoy 500 Maintenance

Log.
Instruction – Sleep Mode, Suspend Activity and Shutdown

Your instructor will discuss the functional differences between Sleep
Mode, Suspend Activity and Shutdown on the Envoy 500 chemistry
analyzer.
Additional information can be found in Section 2.9 (Ending Operation) of

the Envoy Operator manual.
Instruction – Waking up the Envoy 500 when it is in Suspended Activity Mode

Upon your return to work, there may come a time where you discover that
a patient sample needs to be run AFTER you have put the Envoy 500 into
Suspend Activity.
Your instructor will demonstrate how to wake up the Envoy when it is in

Suspend Activity Mode.
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).
29
30
Module 5 ENVOY 500 USER SOFTWARE

In this training module, your instructor will provide comprehensive
descriptions of all of the Envoy 500 User Software menu options.
1. Demonstrate an ability to navigate through the menus and submenus

of the Envoy 500 User Software
2. Understand the functions and features of all menus and submenus
Instruction – Direct Access Icons

Your instructor will discuss the function of each Direct Access Icon.
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
Complete menu and submenu descriptions can be found in Section 4 of

your Envoy Operator manual. Your instructor will now discuss each option
in detail.
-- Master list of test parameters for all reagents sold by Vital
-- Used to manually assign reagents to positions on the reagent tray
-- Active list of tests that your account is performing
-- Create, modify and delete profiles (panels)
-- Used to order and run test calibrations (standards)
-- Used to order and run controls when there is no on-site LIS
-- Used to display actual test reaction curves in graph format

-- Sorts Results Log by TEST instead of SAMPLE (must be Idle)
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-- Used to enter samples for Routine or STAT testing
-- Used to enter samples for BATCH testing (not currently used)
-- Starts all pending samples on the work list

-- Repeats selected test(s) for a single sample or the entire work list
-- Sample results and Info Flags are displayed here
-- Displays Real Time Log (results display as they are completed)
-- Clears the work list by storing QC results in QC Application and

Patient results in Patient Archives
-- Deletes the entire programmed work list after confirmation
-- Used to customize functions in the User software (see below)
-- Maintenance functions are performed through this option
-- System alignments are performed through this option
-- Zero Photometer readings are printed through this option
-- Resettable log that displays when the next maintenance task is

due
-- Automatic cuvette washing cycle that initiates after Envoy has
been idle for 30 minutes
-- Allows user to select date and time of next work day + perform
End of Day cuvette and ISE cleaning cycles
-- Allows user to properly close the Envoy 500 User software, shut
off the instrument, and perform End of Day cuvette and ISE
cleaning cycle
32
-- Location of Archived Patient Results (discussed in detail later)

-- Location of Archived Control Results (discussed in detail later)
-- Uses data from Patient Archives to calculate precision statistics
-- Used to create an external Master Backup of system

-- Used to restore data from the external Master Backup
-- Temporary file where recent errors and navigational information

is stored. Tech Support may request this log to be faxed in.
-- Only active when the Envoy 500 is interfaced with an LIS
-- For Vital Diagnostics field support

-- Automatic Internal Patient Archive backup
-- Creates a Reagent Summary of assigned reagent positions, lot
numbers and expiration dates
-- Allows a different operator to Log On to the Envoy 500
Instruction – Analyzer Set-Up

The Analyzer Set-Up menu which is located in the Functions folder is used
to customize functions in the Envoy 500 User software.
Additional information about features and functions of Analyzer Set-Up is

located in section 6.4 of your Envoy Operator Manual.
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.
Instruction – Perform Suspend Activity on your Envoy 500

Your instructor will have you program your Envoy for the next working day
with an ETA of 8:30 am.
This completes Day 1 of your Envoy 500 User Training!
33
34

In this module, the user will perform all Envoy 500 activities associated
with a normal day in the laboratory.
At the conclusion of this section, the user will be able to:
1. Perform all Envoy 500 Start-Up procedures and utilize

provided hand outs
2. Review Reagent Management
3. Calibrate all tests and repeat a single test calibration
4. Run Controls on all tests and repeat a single test control
5. Effectively evaluate all calibration and control results
6. Run Patients, both in Routine and STAT modes
7. Perform the End of Day procedures
8. Place the Envoy 500 in Shutdown
Instruction – Utilizing Envoy 500 Handouts

Your instructor will assist you in performing all activities listed on the
Envoy 500 Daily Operation Guide. Your instructor will also have you use
the Envoy Maintenance Log to record your normal daily activities.
Instruction – Daily Start-Up
Activity 6-1
1. Follow Pages 1 – 2 of the Envoy 500 Daily Operation Guide.
2. Using the information on Page 3 of the Daily Operation Guide, perform

calibrations (standardizations) of all tests being performed on your
system.
3. Upon their completion, your instructor will assist you in evaluating the
calibration results.
4. If any calibrations do not pass, your instructor will demonstrate the

proper way in which to repeat it. If all calibrations have passed, select
one test to recalibrate anyway, following the procedure on Page 4 (Re-
run ‘Out of Range’ Standards).
35
5. When the repeated calibration passes, order and perform QC

(controls) on all tests being performed on your system using the
information provided on Page 4 of the Envoy 500 Daily Operation
Guide.
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).
8. Your instructor will discuss how control repetitions appear on the

Specimen Log and how the results of the sample that display last
‘over-ride’ those that were performed before it (appearing above it on
the Specimen Log).
9. When all calibrations and controls have been successfully completed,

follow the procedure on Page 5 (Print Calibration / Control Report &
Archive to clear log) to print and archive all results.
10. Record all Daily – A.M. maintenance on the Envoy Maintenance Log.
Instruction – Analyzing Samples
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
 Chart Number: 2011.2

Patient: Wilma Flintstone
Provider: Dr. B. Rubble
Notes: Patient has kidney stones
Tests Ordered: BUN, Creatinine
 Chart Number: 450-50-1515A

Patient: Santa Claus
Tests Ordered: Electrolyte panel
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2. Load and start all three (3) samples.
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.
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.
7. You have just received another Routine sample that needs to be

added to this run. Following the procedure on Page 7 of the Daily
Operation Guide - Adding Additional Patients to an Existing
Worklist, order the following patient:
Patient: Tweety Bird
Provider: Dr. Pudicat
Tests Ordered: Glucose
8. Repeat the CRE on Wilma Flintstone when the sample is completed.

When all testing has been completed, begin the End of Day routine by
following the instructions on Page 8 of the Daily Operation Guide.
1. Check regular reagent volumes.
2. Insert the ISE Cleaner (Pepsin) and check Special (ISE) Reagent
volumes.
37
3. Visually check the volume of the External Reference Solution.
4. Check the volume of Rinse Solution in the box.
5. Replace Reagent Caps on ALP and CRE reagent 1 and 2.
6. Empty Waste.
7. Archive Data, if you have not already done so.
8. Backup Patient Archives as per instructions. Make sure that you

understand the importance of performing a daily Patient Archive
backup. Ask your instructor for clarification, if necessary.
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.
10. Perform a Shutdown instead of a Suspend Activity of your system at

this time. Note that your system must be completely Shutdown at least
once each week to ensure good performance.
11. Record all Daily – P.M. maintenance on the Envoy Maintenance Log.
12. Allow Shutdown to complete.
13. Restart the Envoy 500. Watch the start up sequence.
38
Module 7 DATA HANDLING – PROGRAMS
In this module, the user will be introduced to the Data Handling Menu.
1. Understand the functions and features found in the Patient

Archive application of the Envoy 500 User software
2. Understand the functions and features found in the Quality
Control application of the Envoy 500 User software
3. Recognize the functions and features found in the Population
application of the Envoy 500 User software.
Estimated Time to completion – 1 hour
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).
The remaining three are found in the DATA HANDLING folder:

 Patient Archives
 Quality Control
 Population
Additional, detailed information on these three programs is located in

Section 5.0 (Data Handling) of the Envoy Operator manual.
Instruction – Patient Archives Program

Your instructor will introduce you to the Patient Archives application. See
Section 5.4 of the Envoy Operator Manual for more detailed information.
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.
3. Experiment with other Search categories (date, ID code, surname)
4. Attempt to modify a patient result – Level 1 access level is required to

perform this function.
39
 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.
5. Return to Patient Archives and find Speedy Gonzales’s GLU result.

Pretend that it was repeated and modify the result.
6. Reprint the report.
7. Select the Test Report command button. Your instructor will explain
this feature.
8. Reports viewed through Patient Archives can be exported in .csv

format and imported into Excel by following the instructions found in
Section 5.4.4 of the Envoy Operator Manual.
9. Your instructor will show you how to create a Monthly backup and
delete all result in the Patient Archives application.
Vital Diagnostics recommends that to ensure the integrity of your

patient database, all reports stored in the Patient Archive application
should be backed up onto an external media and deleted once every
month.
Following the instructions found on Page 10 of the Daily Operation

Guide, delete all reports that are stored in the Patient Archive
application.
10. Your instructor will demonstrate how to locate a patient report from the
Monthly backup that was just created.
Accessing Patient Reports from External Patient Archives:

 Insert the appropriate Removable Disk into a USB port on the
front of the Envoy 500.
 Navigate to: Data Handling > Patient Archives > Utilities >
External Archives
 In the “Look in” field, select the drop-down arrow and slide down
to “Removable Disk E”.
 Double-click on the appropriate month’s folder to open.
 Double-click on the “mm-dd-yyyyData.db” file to select it.
 Click on SEARCH.
 Locate the patient in the list and double click it.
40
 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.
Instruction – Quality Control Program

Your instructor will introduce you to the Quality Control application. See
Section 5.2 of the Envoy Operator Manual for more detailed information.
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
2. Exiting the Program – Notice that there is no Exit button on this

screen. To exit the program, the user must click on the ‘exit’ Direct
Access icon shown below.
3. Memorizing Data Message – If the Quality Control application has not

been opened for while, you may be blocked from operation while a
Memorizing Data
window is displayed on the screen. After archiving control results,
those results are held until the program is opened. If the program is
open on a regular basis, this process may take only seconds.
However, if the Quality Control program has not been opened for an
extended period of time, it may take awhile for the Memorizing Data
window to disappear. Be patient while the control data is being
imported into the system.
41
4. Reindex Database – It is recommended to Reindex the Database of

the Quality Control program every time that it is open. Reindexing
addresses sorting and corruption issues within the program. This is
done by selecting Functions > Reindex Database from the top or side
menu.
5. Data Management – Select Data Management from the top or side
menu or by clicking on the Direct Access icon shown below.
Data management
B C
E
F
G
(A) – Drop-down boxes allowing selection of Analysis, Lot and Method

appear on the left. All three drop-down boxes must be populated in
order to utilize the entire application.
(B) – Select the appropriate level of control (Level 1 or Level 2).
(C) – Choose the display option of the data points – Daily or Total.
 Daily – displays individual QC data points run on the selected

day for the selected test. Example: If multiple controls
are performed on the selected day (ISE morning and
afternoon), both points will display on graph. Any data
points that require deletion must be deleted through
Daily.
 Total – displays the average of all QC data points run on the
selected day for the selected test.
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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.
(F) – Levey Jennings Graphs:

 Westgard Graphs utilize the theoretical mean (range printed on
the control’s package insert). Red dotted lines indicate the high
and low package insert range.
The Westgard Graphs display statistics in Sigma Format where

4S = 2SD, 2S = 1SD, and 1S = 0.5SD.
43
 Daily Chart Graphs (SD) utilizes the actual (calculated) mean.

Red dotted lines indicate the high and low package insert range.
The Daily (SD) Chart Graphs display statistics in SD Format.
(G) – Print. When Print is selected, the following window appears.

 Accept – Select this to print Westgard Graphs
 Cancel – Select this to print Daily (SD) Chart Graphs.
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.
2. Print a Daily Chart (SD) Graph including the same data.
3. Print a Westgard Graph that includes ‘All data’ for BUN Level 2.
4. Delete an ‘Out of Control’ Result from the QC Program
5. Following the instructions on Page 9 of the Daily Operation Guide,

perform a QC Backup to an external media.
44
NOTE: This is the same procedure that would be performed if your

laboratory participates in the VQC Program. This program is
included at no charge with the purchase of your Envoy 500
and will be discussed in Module 13.
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
NOTE: It is not possible to restore deleted QC data.
Instruction – Population Program

The Population Program manages data, computes statistics, and displays
graphs on tests performed by the Envoy 500. Your installer will utilize this
program to perform Precision and Accuracy verifications on your new
Envoy 500.
Detailed information about the Population program can be found in

Section 5.3 of the Envoy Operator Manual.
Activity 7-5
1. Navigate to Data Handling > Population
2. Follow the instructions found on Page 10 of the Daily Operation Guide

and delete the Population Archive. This procedure should be
performed monthly to ensure the integrity of your patient database.
Instruction – Analyzer Configuration

This program option is used by Vital Diagnostics Service Personnel.
Instruction – Restore Patient Archive

This feature was briefly discussed on Page 41 of this manual. Additional
information can be found in Section 5.6 of the Envoy Operator Manual.
45
Instruction – Reagent Lot Information

When reagent barcodes are enabled, this function displays the reagent
position, test code, lot number and expiration date information for all bar-
coded Vital Diagnostics reagents in the current reagent tray. This list can
be printed at any time and used as a record of reagent lot number history.
Instruction – Log Off:

This function allows a different operator to sign into the Operative Program
without shutting down the Envoy. The new user is required to enter their
operator name and password. Most accounts prefer general user names
and passwords negating the need for this option.
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Module 8 ISE MODULE OPERATION
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 –
1. Recognize the hardware components that compose the Envoy

500 ISE Module.
2. Understand the priming cycle of the Envoy 500 ISE Module.
3. Understand the Extra ISE Wash cycle of the Envoy 500 ISE
Module.
4. Understand the calibration cycle of the Envoy 500 ISE Module.
Instruction – ISE Test Parameters

Your instructor will discuss the ISE Parameters, Standards and Control
screens.
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.
Instruction – Prime ISE Cycle

Your instructor will discuss the process by which the ISE Module Primes.
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,
47
step-by-step. Detailed information on the Prime ISE Module cycle can

be found in Section 6.1.5 of the Envoy Operator Manual.
The Prime ISE Module cycle does the following:

 Fills the fluidic path of the ISE module by dispensing Envoy 500
Baseline Solution
 Moves External Reference Solution through the Reference
Pump Tubing and through the Reference Electrode
Priming may become more necessary as the Reference Pump

Tubing ages or after the Envoy has been idle for an extended time.
A single ISE Module Prime procedure is completed in approximately

60 seconds. Multiple Prime cycles can be ordered by clicking on the
Prime ISE Module button in Utility Tools for the desired number of
times.
Instruction – Wash ISE Module

Your instructor will discuss the process by which the ISE Module performs
the Wash ISE cycle.
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.
The Wash ISE cycle takes approximately 14 minutes to complete.
48
Instruction – ISE Calibration Cycle

Your instructor will discuss the process by which the Envoy 500 ISE
Module calibrates.
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.
Locate the Optimal Calibration Readings table in Section 9.7.3 of the

Envoy Operation Manual. Your instructor will discuss its importance
when performing basic ISE Module troubleshooting.
49
50
Module 9 ISE MODULE PREVENTIVE MAINTENANCE

In this module, the user will perform all routine ISE Module preventive
maintenance.
1. Confidently handle the Envoy 500 ISE Module.

2. Perform all ISE Module preventive maintenance on the Envoy
500.
Instruction – ISE Module Maintenance

Preventive Maintenance is performed to reduce system or component
malfunctions that could potentially cause erroneous results and system
failures. The goal is to extend the life of the Envoy 500 and provide the
lowest overall cost for maintaining the analyzer.
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.
2. Monthly Preventive Maintenance

 Replace ISE Ground ByPass Tube (PN: 56127). This tubing is
included in the Envoy Maintenance Kit (PN: 56145)
3. Quarterly Preventive Maintenance

 Replace K+ Electrode (PN: 279-001)
 Replace Cl Electrode
-
(PN: 280-001)
 Replace CO2 Electrode (PN: 275-001)
 Replace ISE Fluidic Tubing Set – all components are included in
the Envoy Maintenance Kit (PN: 56145)
o ISE Cup to Electrode Tubing (PN: 56124)
o ISE Reference Pump Tubing (PN: 56152)
o ISE Waste Tubing (PN: 56153)
51
Peristaltic Pump Tubings (both Reference and Waste) must be

installed without stretching the distance between the collars.
Installation Procedure: Install the peristaltic tube by gently

wrapping it around the pump rollers. Take care not to stretch the
tube by more than 3/8” (1cm) beyond the brackets. Be sure that
the tube does not become twisted during installation as this may
prevent pumping.
4. Annual Preventive Maintenance

 Replace Na+ Electrode (PN: 278-001)
 Replace Reference Electrode (PN: 273-001)
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.
52
It is important to remember that any time the ISE module is handled or

removed from its chamber, an analyzer Reset (F5) must be completed
(two reset cycles are preferred).
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.
53
54
Module 10 PREVENTIVE MAINTENANCE ON THE ENVOY 500

In this module, the user will be instructed to perform all routine Envoy 500
Preventive Maintenance activities.
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.
Instruction – Envoy Spare Parts Kit

The instructor will discuss all components that are included in the spare
parts kit that is included with the Envoy 500 Chemistry System.
Instruction – Daily AM Maintenance Procedures

Using the Envoy Maintenance Log the instructor will review all Daily AM
maintenance procedures.
Instruction – Daily PM Maintenance Procedures

Using the Envoy Maintenance Log the instructor will review all Daily PM
maintenance procedures.
Instruction – Envoy Maintenance Logs (Printed & On Screen)

On Screen Maintenance Log –Navigate to Functions > Maintenance
Log. Your instructor will explain all maintenance options that are listed on
this log.
55
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.
Printed Maintenance Log – The printed Envoy Maintenance Log is more

complete and allows for more specific performed maintenance entries.
Instruction – Utility Tools

Your instructor will discuss / demonstrate every maintenance function that
appears in Utility Tools.
Navigate to Functions > Utility Tools
More detailed descriptions of each option can be found in Section 6.0

(Service Functions) of the Envoy 500 Operator manual.
56
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.
2. Wash cuvettes is the same wash that can be performed when

selecting SUSPEND ACTIVITY or SHUTDOWN.
3. Extra wash cuvette is a 15 minute, once per week maintenance

procedure that is performed using a 5% bleach solution. All 34
cuvettes will be cleaned with the 5% bleach solution and then rinsed
and filled with Envoy Rinse Solution.
The 5% bleach solution is stable if stored CAPPED when not in use. If

left uncapped, the remaining solution must be discarded.
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.
5. Prime ISE Module accomplishes two things during its execution:
 By dispensing Envoy 500 Baseline Solution, it fills the fluidic

path of the ISE Module.
 Allows for the ISE External Reference Solution to be dispensed
into the Reference Electrode. In some instances, multiple
priming cycles may become necessary in order to successfully
deliver Reference Solution to the Reference Electrode. The
57
priming may become more necessary as the Reference Pump

Tubing ages or after the Envoy has been idle for an extended
time.
The Prime ISE module is automatically performed every time the

Envoy 500 starts and stops.
Each Prime ISE module cycle takes approximately 60 seconds to

complete. When completed the following message will appear:
6. Wash ISE Module is the same ISE wash that can be performed when
selecting SUSPEND ACTIVITY or SHUTDOWN.
Be sure to check for minimum volumes of ISE Cleaner (Pepsin), ISE

Conditioner, and ISE Baseline solutions prior to initiating cycle.
7. Zeroing on Water performs a Photometer Reading on all 34 cuvettes

using Envoy 500 Rinse Solution. The optical transmissions of each
cuvette serve as a “Blank” for that cuvette.
NOTE: This function must be performed daily and the Optical

Transmission report be reviewed to determine if there are an
excessive number of low transmittance cuvettes before any
sample testing is started.
Zero photometer readings between 50 -110 are considered

acceptable. Daily Zero photometer readings will decrease slowly.
8. Check Volumes checks the volumes of ALL reagents present in the

reagent tray and in the ISE Special Reagents without scanning reagent
barcodes. The volumes are then updated in the “View volumes status”
window (F10).
9. Volume Calibration (Liquid Volume Calibration – LVC) is performed

to establish reference volumes at each of the aspirating/dispensing
locations:
 Reagent boat
 Sample cup
 ISE reagent station
 Cuvettes
58
A Volume Calibration cycle is ‘as needed’ maintenance and should be

performed if instructed to do so by Vital Diagnostics Technical Support
department or if ‘low reagent’ alerts do not appear prior to running out
of reagent. See Section 6.1.9. of the Envoy Operator Manual for
detailed instructions.
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.
11. Lamp Set up is required when:
 The Photometric Halogen Lamp is replaced

 An excessive number of cuvettes falling below 50% are shown
on the ‘Show Optical Transmission Report’ after Zeroing on
Water.
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.
Instruction – Weekly Maintenance Procedures

Your instructor will discuss the following Weekly Maintenance Procedures:
1. Clean Sample Needle with alcohol swab. Using an alcohol swab,

clean the sample needle from top to bottom.
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.
59
3. Review Levey Jennings Charts – It is a CLIA requirement that all LJ

Charts be visually reviewed weekly in an attempt to notice any shifts or
trends in results. Viewing and printing LJ Charts was discussed in
detail during Module 7 (Data Handling Menu).
4. Perform Shutdown of Operating System – Performing a Shutdown

cycle once per week allows the computer to reset. Also, restarting the
Envoy system ensures that all System Diagnostic Checks are
performed at least once per week.
Perform a system shutdown. Restart the Envoy by pressing the white

button found under the monitor.
Instruction – Monthly Maintenance Procedures

Your instructor will discuss the following Monthly Maintenance
Procedures:
1. Print Levey-Jennings Charts for review by Director – It is a CLIA

requirement that your laboratory director review all LJ Charts every
month.
2. Backup QC Data (Stand-Alone Envoys) – If all QC data is being

printed on a monthly basis, this is not really necessary. However, this
same procedure is used to export data used in the Vital Diagnostics
VQC program (optional, free of charge) which compares your
laboratory results with other labs running the Envoy 500 system.
3. Backup Patient Archives (Stand Alone Envoys) – The Envoy 500

automatically performs an internal backup every day the software is
operational. However, this automatic backup does not lessen the need
for external backups. To ensure that the least amount of data be lost
in the instance of a hardware failure, Daily and Monthly backups must
be performed on all stand alone Envoys.
4. Delete Patient Archives & Population Archive – After performing the

monthly backup, the contents of both the Patient Archives and
Population programs should be deleted to ensure the proper operation
of the system.
5. Replace ISE Ground ByPass Tubing – Discussed and performed in

Module 9 (ISE Module Maintenance)
60
Instruction – Quarterly (3 Months) Maintenance Procedures

Your instructor will discuss the following Quarterly Maintenance
Procedures:
1. Replace Envoy Maintenance Kit – Discussed and performed in

Module 9 (ISE Module Maintenance).
2. Replace K Electrode – Discussed and performed in Module 9 (ISE

Module Maintenance).
3. Replace Cl Electrode – Discussed and performed in Module 9 (ISE

4. Replace CO2 Electrode – Discussed and performed in Module 9 (ISE

Instruction – Semiannual (6 Months) Maintenance Procedures

Your instructor will discuss the following Semi-annual Maintenance
Procedures:
1. Replace Peristaltic Cartridges – There are two (2) peristaltic pump

cartridges on your Envoy 500. These cartridges control the movement
of Rinse Solution that is required to clean the interior and exterior
surfaces of the sample probes.
Both peristaltic pump cartridges require replacement by the user every

six (6) months. Detailed instructions can be found in Section 7.4.3 of
the Envoy Operator Manual
An Empty Fluidics cycle must be performed prior to removing

cartridges.
.
Instruction – Annual Maintenance Procedures

Your instructor will discuss the following Annual Maintenance Procedures:
1. Replace Reference Electrode – Discussed and performed in Module

9 (ISE Module Maintenance).
2. Replace Na Electrode – Discussed and performed in Module 9 (ISE

3. Annual PM by Service Engineer – An annual PM visit by a Vital

Diagnostics trained Service Engineer will be performed if your system
is under warranty or service contract.
61
Instruction – As Needed Maintenance Procedures

Your instructor will discuss the following As Needed Maintenance
Procedures:
1. Mechanical Calibrations (Alignments) – This menu allows

mechanical adjustments to the sampling arms, cuvette assembly,
sample tray, and reagent tray.
Mechanical Calibrations are ‘as needed’ maintenance and will be

required only if the home positions of any of the above components
appear to be incorrect.
Detailed alignment information can be found in Section 6.2 of the

Envoy Operator Manual.
Your instructor will assist you in performing all Mechanical Calibrations

on your Envoy 500.
2. Perform Volume Calibration (LVC) – Discussed earlier in this

Module.
3. Replace Lamp & Perform Lamp Setup – Discussed earlier in this

Module.
4. Perform Wash ISE Module (with Pepsin) – Discussed in Module 9

(ISE Module Maintenance).
5. Perform Chloride Electrode Cleaning – Discussed in Module 9 (ISE

Instruction – Abbreviated End of Day

1. Cap labile reagents
2. Select Data Handling > Log Off
62

In this module, the user will perform all routine daily activities associated
with a normal day in the laboratory.
1. Perform all Envoy 500 Daily Operation Procedures and gain

confidence in the ability to successfully operate the system.
2. Recognize that the status of a sample is related to the color
and font of the ID code on the Work List.
3. Identify possible compromised patient results via reviewing
every result for Info Flags prior to final reporting.
4. Identify when reagents generate Volume Limit alerts.
5. Independently perform all End of Day activities.
Estimated Time to completion – 1 hour and 15 minutes
Instruction – More Daily Operation

Your instructor will provide independent time for you to work through the
following activity.
Activity 11-1
Follow your Daily Operation Guide and complete the following:
1. Log-In
2. Perform a complete Start-Up
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.
63
5. Run controls on ALL TESTS – This also simulates a normal operating

day as both levels of controls must be run for every test that will be
reported that day. OR
Run controls on ISE and GLU only (depending on training schedule).

NOTE: Afternoon control runs only need to include ISE and any other
test whose reagent was replaced and calibrated.
6. If time permits, program the following patients:

Patient: Wilma Flintstone
Provider: Dr. Barney Rubble
Notes: Patient has kidney stones
Tests Ordered: BUN and Creatinine

Patient: Baby Ruth
Tests Ordered: GLU
 Chart Number: 8500-15

Patient: Donald Duck
Tests Ordered: CMP

Patient: James Bond
Provider: Dr. Goldfinger
Tests Ordered: ISE
 Chart Number: 344-45-5555

Patient: Snow White
Tests Ordered: CMP and Lipid Panel

Patient: Cindy Lou Who
Provider: Dr. Suess
Tests Ordered: Lipid

Patient: Hans Solo
Tests Ordered: CRE and BUN

Patient: Curious George
Tests Ordered: BMP
64
7. Insert samples and start only the first four (4) patients.
8. Open your Envoy Operator Manual to Section 2.7.1. Your instructor

will discuss how a sample’s status can be determined by the position
and ID code color and orientation.
9. The contents of the hidden Re-run work list will be discussed.
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.
12. Notify your instructor when all testing is complete.
Instruction – Info Flags

The Envoy uses flag symbols to alert the operator of information regarding
the result or sample. The symbols are displayed as Info Flags in View
Results for Sample or the Specimen Log.
It is important to note that the printed patient sample report does not
contain the flag symbol, but instead uses an asterisk (*).
Every patient report should be visually reviewed in the Specimen

Log for Info Flags prior to releasing the report. Any results
displaying an Info Flag CAN NOT be reported.
Detailed information can be found in Section 3.6 of the Envoy Operator

Manual.
Instruction – Volume Limit Alerts

Volume Limit alerts will be automatically generated when a reagent’s
volume reaches approximately 10 remaining tests. This alert will reappear
every time the sample probe accesses that reagent.
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).
65
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.
3. Add a PRO to each of the samples on your work list.
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.
This completes Day 2 of your Envoy 500 User Training!
66
Module 12 BASIC TROUBLESHOOTING & PROBLEM SOLVING

In this module, the user will independently perform System Start-Up and
then be introduced to Basic Troubleshooting and Problem Solving
Techniques on the Envoy 500.
1. Perform all Envoy 500 Daily Operation Procedures and gain

confidence in the ability to successfully operate the system.
2. Utilize the Troubleshooting sections of the Envoy Operator
Manual to investigate and solve basic problems that may arise.
3. Demonstrate the ability to properly evaluate basic calibration
and control failures on the Envoy.
4. Execute basic ISE troubleshooting utilizing the ISE
Troubleshooting Flowchart.
Instruction – Daily Start-Up
Activity 12-1
1. Follow Pages 1 – 2 of the Daily Operation Guide and perform normal
daily Start-up.
2. Perform calibration on ISE only.
3. Your instructor will discuss basic ISE Troubleshooting utilizing

Appendix A-5 in the Envoy Operator Manual - ISE Troubleshooting
Flow Charts.
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.
Instruction – Log Files

On occasion, a Vital Diagnostics Technical Support Representative may
request that your Envoy 500 Log Files be printed and faxed to them. More
detailed information can be found in Section 3.4.1 of the Envoy Operator
Manual.
67
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).
2. Locate yesterday’s Log Files and pretend to print.
68
Module 13 ADVANCED DAILY OPERATION

In this module, the user will be introduced to Advanced Daily Operation of
the Envoy 500.
1. Check and update all applicable Calibrator Set Points.

2. Check and update QC ranges for all tests with the release of a
new lot number of controls.
3. Properly perform Duplicate Patient Testing.
4. Demonstrate how to replace Rinse Solution without losing
pending test results.
5. Program Pathological Repeats (Automatic Repeats).
6. Exhibit understanding in performing Hyperactive and Manual
dilutions.
7. Perform repeat analysis through the Re-Run screen of the
Work List.
8. Understand when and why the system clones ID numbers.
9. Properly execute the “Screen Freeze” procedure.
10. Demonstrate the ability to locate and edit Reference ranges.
11. Demonstrate the ability to perform Reportable Range studies.
12. Locate and edit Reportable ranges, as required.
13. Exhibit basic knowledge of Envoy operation when interfaced to
a Laboratory Information System.
14. Understand the importance of implementing and retaining
Technical Bulletins.
15. Identify the purpose and function of the VQC program.
16. Recognize services that are offered by our TLC Consulting
services.
Instruction – Verifying / Editing Calibrator Set Points

Calibrator lot numbers must be checked each time the first bottle is taken
from a box. Calibrator set points are lot specific, therefore a different lot
number will mean that new set point(s) must be programmed into the
Envoy to ensure accurate results.
Serum Calibrator (Multi-Cal) is produced in large quantities meaning less

lot number / set point changes. However, all set points should still be
verified when opening a new box of calibrator.
69
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.
Instruction – Programming a New Lot Number of Controls

Control lot numbers change periodically. When they do, it is the user’s
responsibility to program the new lot number and applicable QC ranges.
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.
Instruction – Duplicate Patient Ordering & Running out of Rinse Solution

Your instructor will explain the purpose and function of the Duplicate
Patient icon which is located on the Enter Patients screen to the right of
the I.D. field.
NOTE: This icon will not be visible if Analyzer Setup has been configured
to insert all new orders in the Extra Patients List.
70
Detailed information on using the Duplicate Patient feature is found in

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.
2. Insert one (1) cup of sample into Sample Position #1.
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.
71
6. When the displayed message changes to ‘No Tests in Incubation’,

insert the Rinse Solution line back into the container (simulating box
replacement) and select EXIT to reset the Envoy and refill the
reservoir.
7. If this was an actual run, the user would have to restart the work list to
continue testing (Options > Run > All).
Instruction – Pathological Repeats

The Envoy 500 has the ability to automatically repeat any result that falls
outside of a pre-programmed range. This option is configured by simply
selecting the Re-run Pathological option in that Test’s Parameters.
72
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.
Detailed information about the Re-run Pathological option can be found in

Instruction – Hyperactive (Automatic) Dilutions on the Envoy 500

The Envoy 500 has the ability to automatically dilute results that fall
outside of the pre-programmed Test Limit. This option is pre-configured for
all enzymes. The Envoy 500 will perform an automatic 1:2 dilution on all
enzyme results that fall outside the pre-programmed Test Limit (Conc).
73
Hyperactive dilutions can be triggered by any of the following:

 Test limit (Conc) Info Flag on Specimen Log is “I”
 Final ABS (mABS) Info Flag on Specimen Log is “A”
 Max ABS Delta (mABS) Info Flag on Specimen Log is “d”
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.
2. Program the sample and watch for the hyperactive dilution to be

triggered.
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.
Instruction – Manual Dilutions on the Envoy 500

Any test that is not configured to perform Hyperactive Dilutions and has a
result that falls above the programmed Test Limit will require one of the
following actions:
 Manual dilution
 Report result as greater than the programmed Test Limit (example:
TRG > 750 mg/dL)
 Sample sent to reference laboratory for further analysis
Manual dilutions will require calibrated automatic pipettes for accurate

delivery of sample and diluent.
Detailed information on performing manual dilutions can be found in

Appendix A-4 of the Envoy Operator Manual.
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).
1. Program and run the sample undiluted.
74
2. When the Info Flag appears, your instructor will demonstrate how to
repeat the sample using a supplied manual dilution.
Instruction – Repeating Results on the Envoy 500

There are two (2) ways to repeat results on the Envoy 500.
 Through Functions > Re-run analysis
 Through Functions > Routine/STAT > Rerun
Your instructor will discuss when to use the above options.
Activity 13-6
1. Program and run the following samples:
Patient: James Bond
Tests Ordered: CRE, ISE
 Chart Number: 05102001LS

Patient: Minnie Mouse
Tests Ordered: BMP
2. When James Bond is completed, repeat his CRE through the

Worklist > Re-run analysis option.
3. When Minnie Mouse is completed, repeat her ISE through Worklist >
Routine/STAT > Rerun.
4. How do these two options differ? As an operator, when would it be

best to use each option?
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
Instruction – Cloning Sample IDs

If a work list is not archived prior to re-using an existing ID Code, the
operating software will ask the user if they wish to clone that ID Code.
Activity 13-7
1. Navigate to Worklist > Routine/STAT > New Entry. Order another test
on ID 007 (James Bond).
75
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).
Instruction – Screen Freezes

Your instructor will direct you to the last page of the Envoy Daily Operation
Guide and will describe the proper procedure to use if or when a screen
freeze might occur on your system.
Instruction – Editing Patient Reference (Normal) Ranges

On the Envoy, patient reference ranges are associated with the test
parameters. Patient reference ranges can be adjusted (without a
secondary password) by the laboratory director in order to reflect the
patient population in your laboratory.
Instruction – Calibration Verification Studies (Linearity) & Adjusting Reportable

Ranges
CLIA requires that all moderately complex laboratories perform Calibration
Verification studies every six months. After the studies are complete, the
reportable range for each test must be adjusted to reflect these results.
Activity 13-8
Your instructor will demonstrate how to program and run Calibration
Verification Studies on the Envoy 500.
76
Instruction – Vital Diagnostics Technical Bulletins

Technical Bulletins share important information and/or updates with our
Vital Diagnostics Envoy 500 customers.
All Technical Bulletins are consecutively numbered.
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.
Carefully read each Technical Bulletin as it is received.

 If it does not apply to your account (test not performed, etc.) initial it
and insert it into the back of the Envoy Operator Manual and ensure
that no Technical Bulletins have been missed.
 If it does apply to your account, carefully enact all changes. Call Vital
Diagnostics Technical Support if clarification is required. Mark the
document as “performed”, date and initial. Insert it into the back of the
Envoy Operator Manual and ensure that no Technical Bulletins have
been missed.
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.
Instruction – VQC Program

Vital Diagnostics offers all Envoy customers the opportunity to participate
in our free, on-line peer grouping program (VQC).
Registered participating laboratories export their Envoy QC results to an

external drive following the instructions on Page 9 (Quality Control
Backup) of the Daily Operation Guide.
The exported file is then emailed to Vital Diagnostics Technical Support.

Data is inserted into the on-line program and results are available at
www.vitaldiagnostics.com.
Laboratories should review the VQC reports monthly to evaluate the

performance of their Envoy 500, the reagents they are using, and/or the
users that are operating the Envoy 500.
77
Instruction – Total Lab Care (TLC) Consulting Services

Total Lab Care (TLC) is the laboratory consulting branch of Vital
Diagnostics. It is comprised of experienced laboratory professionals that
can handle the regulatory and reimbursement needs of your laboratory.
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.
If your laboratory or office needs additional assistance, TLC can help.

Contact information is listed on the flyer that you received or you can
simply call Vital Diagnostics Technical Support department and they will
have a TLC representative contact you.
Instruction – On-site LIS & Barcoded Samples

Your instructor will discuss Envoy 500 operation when it is interfaced to an
LIS (Laboratory Information System), if applicable to this class.
LIS operation differs between manufacturers. Some systems require that

QC be ordered on their computer and assigned an ID number prior to
inserting it onto the Envoy. Others allow users to program QC on the
Envoy and then match up the sample ID. Vital Diagnostics installers are
familiar with the most common LIS systems; however, since so many
different systems are available, it may be necessary for you to contact
your LIS manufacturer for specific operating details.
Most Laboratory Information Systems include label printers. These

printers print barcoded sample labels which can be attached to the
primary sample tubes used with the Envoy. They provide positive sample
identification when positioned correctly on the sample tube (barcode must
be applied so that it is viewable between the two bars of the sample
wheel).
If barcoded samples are to be used, it is recommended that the Envoy

500 be configured to send all orders to the Extra Patient Work List. This is
easily configured through Functions > Analyzer Setup.
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.
1. Your instructor will briefly demonstrate the functions and features of

operating the Envoy 500 utilizing sample barcodes.
78
Module 14 Completion of Training

In this training module, you will have the opportunity to demonstrate your
newly learned skills through final written and practical exams.
1. Demonstrate that they have learned the skills required to successfully

operate the Envoy 500 Chemistry System.
2. Complete and submit the Envoy 500 Training Checklist.
Estimated Time to completion - 1 hour 30 minutes
Congratulations on the completion of your

Envoy 500 User Training!
79
80
Vital Diagnostics Family of Products
Chemistry Analyzers
Reagents & Controls
Hematology Analyzers
Immunoassay Analyzers
Laboratory Consulting
Envoy and Vital Diagnostics are registered trademarks of Vital Diagnostics.

Windows is a registered trademark of Microsoft Corporation.
Specifications may be subject to change.
L7320, Rev. –
© 2012. Vital Diagnostics, Inc. All rights reserved.
27 Wellington Road, Lincoln RI 02865

(800) 345-2822 • (401) 642-8400 • Fax (401) 642-9001 • www.vitaldiagnostics.com

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OPERATOR TRAINING MANUAL

ENVOY 500 – Operator Training Manual

1. Introduction & Overview of the Envoy 500 1

2. Envoy 500 Software - Introduction 7

3. Envoy 500 Reagents and Solutions 13

4. Daily Operation - Session #1 25

5. Envoy 500 Software – Comprehensive 31

6. Daily Operation - Session #2 35

7. Data Handling Menu 39

8. ISE Module Operation 47

9. ISE Module Maintenance 51

10. Preventative Maintenance on the Envoy 500 55

11. Daily Operation Session #3 63

12. Basic Troubleshooting & Problem Solving 67

13. Advanced Daily Operation 69

14. Completion of Training 79

Module1 INTRODUCTION AND OVERVIEW OF THE ENVOY 500

1. Read, understand, and comfortably navigate through the Envoy

Estimated Time to completion - 1 hour

Instruction – Operator Manual Navigation

2. Examine the organization of the Operator Manual by reviewing the

3. Navigate through each section as your instructor summarizes the

Instruction – Envoy 500 Hardware Overview

External System Components:

Sample Tray  Divided into three (3) sections:

ISE Module  Electrode Panel

3. Go to your assigned systems and locate the above components. Your

Instruction – Powering-On Your Envoy 500

2. After the Envoy 500 program loads, the Automatic Diagnostic

Instruction – User Name and Password Management

2. List the Password Administrator’s Operator (User) Name and

5. Using the information found in Appendix 3, complete this chart:

Password Level Function Secondary Password

6. Create a New User with Level 1 access.

8. The access level can be changed after Log On by selecting F7 or the

9. Change access level from Normal User to Level 2.

Instruction – System Warm Up

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Module 2 ENVOY 500 SOFTWARE INTRODUCTION

1. Understand how to minimize and maximize the Envoy 500 user

Estimated Time to completion – 30 minutes

Detailed descriptions and functions of items displayed on the Envoy’s

Activity 2-1 Minimizing and Maximizing the Envoy Program

Instruction – Top Menu Bar of the Envoy 500 User Software

Activity 2-2 Navigating through the Top Menu Bar

Instruction – Side Navigation Bar of the Envoy 500 User Software

Activity 2-3 Navigating through the Side Navigation Bar

Instruction – Direct Access Icons

Instruction – Current Version of Software & User Access Level

Instruction – F Key Icons Location & Function

Activity 2-4 F Key Functions

Icon Icon Name F Key Function

Instruction – Bottom Status Bar

Snowflake Icon - Displays the reagent refrigeration unit status. If the

Temperature/Pressure - Ambient Temperature (RT), Cuvette

Activity 2-5 Changing System Date and/or Time

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Module 3 ENVOY 500 REAGENTS & SOLUTIONS

1. Identify and prepare Envoy 500 Rinse Solution.

Estimated Time to completion – 1 hour 45 minutes

Instruction – Preparation and Installation of Rinse Solution

The Envoy Rinse Solution Concentrate contains surfactant and other

Activity 3-1 Rinse Solution Preparation