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Quality Assurance 11-13

4. Click Yes to confirm the delete.


You are returned to the QC select Lot number screen.
The lot number that you deleted no longer displays on the QC select Lot
number screen.
5. Click Done to return to the TAS Main screen.

Archiving a lot Before you add a new lot number, archive the current lot number for future use.
number When you archive a lot number, the accompanying sample types with their
respective reference ranges are archived too.
To archive a lot number:
1. From the TAS Main screen menu, choose QC > Lot number to display the
QC select Lot number screen.
2. Select the lot number that you want to archive.
3. Click Archive.

Note: If there is an existing archive, you are prompted to overwrite it before


continuing.

4. Click OK in the “Archive complete” message that appears.


You are returned to the QC select Lot number screen.
5. Click Done to return to the TAS Main screen.

Restoring a lot You can restore an old lot number to use that lot number’s reference ranges when
number viewing samples.
Before restoring an old lot number, you must archive the current lot number. The
Restore Lot number screen allows you to do this at the same time as restoring a
previous lot number.

Note: When you have finished viewing the old lot number’s reference ranges, you
must restore the current lot number.

To restore a lot number:


1. From the TAS Main screen menu, choose QC > Lot number to display the
QC select Lot number screen.
2. Click Restore.
The Restore Lot number screen displays:

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11-14 Quality Assurance

Figure 11-9, Restore Lot number screen


3. Under Archive, select the current lot number (the lot number that will be
replaced).
4. Under Restore, select the lot number to restore.
5. Click Continue.
6. Click OK in the “Archive complete” message that appears.
The following message displays indicating that you successfully restored
the lot number:

Figure 11-10, Restore successful message


7. Click OK.
You are returned to the QC select Lot number screen.
8. Restore the current lot number by repeating steps 1 through 7, making sure
to select the old lot number to be archived and the current lot number to
be restored.
9. Click Done to return to the TAS Main screen.

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Quality Assurance 11-15

REFERENCE RANGES
Haemonetics has established manufacturer’s reference ranges that outline the
normal maximum and minimum limits for R, K, Angle, and MA for the commonly
used TEG sample types and quality controls. These values are encoded in the
TEG Analytical Software (TAS) and are used by the software to determine if the
test results come inside or outside the ranges.

Note: Since the manufacturer’s reference ranges are periodically updated, always
refer to the product inserts for the current manufacturer’s reference range values.

Local reference The TEG Hemostasis System reference ranges for TEG sample types are derived
ranges from running samples on a heterogeneous population of healthy donors and
statistically analyzing the results to determine the values. Since patient
populations may differ due to geography, age, diet, etc., sites should verify the
manufacturer’s ranges or establish their own reference ranges to enter into the
software.
To verify the manufacturer’s reference ranges or to establish local reference
ranges, follow the procedures in the TEG 5000 System Validation Guide.

Updating It may be necessary to update the reference ranges in the software when a new
reference ranges lot becomes available for a quality control or when studies are updated.
in TAS If your institution establishes its own ranges, refer to “Establishing reference
ranges for quality controls” on page 11-17 for information on recalculating
ranges for a new master lot. Then, if necessary, change the ranges in the software
to match the calculated ranges.
If your institution uses the manufacturer’s reference ranges, compare the
reference ranges in the product insert to the current values in the software. If
necessary, change the reference ranges in the software to match the inserts.

Caution: New reference ranges added to TAS apply to previously run samples in
the database.

Note: Before updating reference ranges in TAS for a quality control sample,
archive the old values so that a history of the reference ranges is maintained for
the quality control samples (refer to “Archiving a lot number” on page 11-13).

To update reference ranges in TAS:


1. From the TAS Main screen, choose Options > User Profile Setup.

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11-16 Quality Assurance

2. In the User Profile Setup screen, click the Normal values tab.

Figure 11-11, Normal values tab


3. In the Select Sample type drop-down list, select the sample type for which
you want to update reference ranges.
4. Using the information provided in the insert, complete the following fields
for each test parameter:

Field Description

Low Value Click this field and enter the corresponding


number for each test parameter.

High Value Click this field and enter the corresponding


number for each test parameter.

5. Click Done.

Reference ranges For sites that choose to run native whole blood samples (whole blood without the
for native addition of any modifiers), the following reference ranges have been established,
samples based on a group sample size of 132 donors:

Sample type R (min) K (min) Angle (deg) MA (mm) G (kd/sc)

Native (N) 12.1 – 26.5 3.2 – 12.8 13.6 – 46.4 41.8 – 63.0 3.2 – 7.1

Citrated 9.4 – 27.4 1.9 – 8.9 22.0 – 58.0 44.4 – 63.6 3.6 – 8.5
Native (CN)

Table 11-12, Reference ranges for native whole blood samples

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Quality Assurance 11-17

Note: Sites wanting to run this type of sample should verify reference ranges or
establish their own reference ranges following the procedure in the TEG 5000
System Validation Guide.

Establishing If your institution chooses to establish its own ranges to monitor quality control
reference ranges (refer to “Establishing quality control ranges” on page 11-8), you can use the
for quality following procedure to obtain the Mean and Standard Deviation (SD) for the
quality controls.
controls
Establishing a new Mean and SD
To use the TEG Analytical Software (TAS) to establish the new Mean and SD for
each level of quality control:
1. Run both levels of quality control a minimum of 20 times (refer to
“Running quality control samples” on page 7-9).
In TAS, in the Patient name field, use the naming convention, “Master Lot
xxxx-xxxx Reference Range Study.” The master lot number can be found
on the control vials.
2. From the TAS Main screen menu, choose QC > Go To to switch to the QC
database.

3. Click .
4. On the Filter criteria screen, do the following:
a. On the Sample type tab, highlight “L1” or “L2.”
b. On the Patient tab, in the Patient name list, highlight “Master Lot xxxx-
xxxx Reference Range Study.”
c. Click Apply filter.

5. On the TAS Main screen, click .


6. On the Report options screen, do the following:
a. Clear the Tracing checkbox.
b. Select Print text in black.
c. Select Default tests (first 10).
d. If applicable, clear the Normals checkbox.
e. Make sure that All samples (total of n) is selected.
f. Click Continue.
7. Print the page of the TEG Analysis Results report that contains the values
for Mean, n, SD, Min, and Max.
8. Compare the Mean values in the report with the manufacturer’s reference
ranges specified on the quality control product insert.
If the Mean values are within range, each will be considered the “new
Mean.”

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11-18 Quality Assurance

9. Calculate each two SD range by multiplying the SD values in the report by


two.
10. Incorporate the SD range around the new mean and monitor throughout
the dating of the product.

Next steps
After establishing the ranges for a new master lot of quality control, do the
following:
⚫ Archive all previous lots of control. Refer to “Archiving a lot number” on
page 11-13.

Caution: Do not change the normal ranges in TAS until the reference range
study is complete and the new master lot is in use.

⚫ Change the LI and Level II ranges in TAS to match the laboratory-


established ranges. Refer to “Updating reference ranges in TAS” on
page 11-15).
⚫ Following your institution’s policy, periodically recalculate the Mean and
SD values during the life of the new lot.

Note: If the TEG instrument is performing correctly, the SD should not


change significantly from lot to lot.

Establishing a preliminary Mean


The following procedure may be used to set a “temporary Mean” until you have
completed the 20 runs of each level of quality control necessary to set the “new
Mean” for R, K, Angle, and MA.
To establish a preliminary Mean and SD:
1. Run both levels of quality control 10 times.
2. Calculate the average Mean value for each parameter from these runs.
3. Ensure that the average Mean falls within the range specified in the quality
control product insert.
If the average Mean values are within range, each will be considered the
“temporary Mean.”
4. Use the established laboratory SD from your installation report.

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Chapter 12

Communicating TEG Data


COMMUNICATING TEG DATA OVERVIEW ................................ 12-2
USING THE ECONSULT FUNCTION ........................................ 12-3
About eConsult ................................................................ 12-3
eConsult prerequisites ....................................................... 12-3
Sending patient data using eConsult ....................................... 12-3
USING THE CAPTURE FUNCTION ............................................ 12-8

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12-2 Communicating TEG Data

COMMUNICATING TEG DATA OVERVIEW


You can use the eConsult and Capture features in TAS to communicate TEG®
analyzer data by sending sample data through e-mail or by electronically
copying and pasting single or multiple tracings into other documents.
This chapter includes the following information:
⚫ Using the eConsult function
⚫ Using the Capture function

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Communicating TEG Data 12-3

USING THE ECONSULT FUNCTION

About eConsult The eConsult feature allows you to consult electronically with colleagues and
specialists by securely sending patient data through e-mail.
The eConsult feature can send files and messages to e-mail recipients using
various devices, including standard PCs, notebooks, and personal digital
assistants (PDAs) as long as they are equipped to receive e-mail with graphical
attachments.
Depending on how you set up your eConsult profile, recipients can receive a
short text message on their cell phone or pager informing them that they have e-
mail for an electronic consultation.

eConsult In order to use the eConsult feature, the following prerequisites must be met:
prerequisites ⚫ The eConsult option must already be configured through the User profile
setup screen.
Typically, your Site Administrator will have set this up for you. However,
if you need to add a recipient to eConsult or to define a server to send
and receive mail, refer to “eConsult Tab” on page 6-25.
⚫ The computer being used must be on the network with access to the mail
servers.

Sending patient The eConsult feature allows you to send patient data to a recipient’s PC, laptop,
data using cell phone, or PDA. The eConsult wizard takes you through the process by
eConsult providing screens to:
⚫ Identify the patient for whom you are sending information while
maintaining patient confidentiality.
⚫ Select sample(s) to send, enter relevant clinical data and contact
information.
⚫ Specify the type of attachment to send and the recipient.

Before You Begin


Before you begin, you must have:
⚫ TAS Main screen displayed

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12-4 Communicating TEG Data

The steps
To send patient data through eConsult:

1. From the TAS Main screen, click . The Introduction screen appears.

Figure 12-1, Introduction screen


2. Select the name of the patient for whom you want to send information.
3. Type the code that indicates the selected patient according to your
institution’s code identification guidelines.

Note: For privacy purposes, the patient’s name is suppressed in the e-mail
and the patient is identified only by the code that you enter.

4. Click Next.
The Select samples screen appears, listing the samples for this patient:

Figure 12-2, Select samples screen

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Communicating TEG Data 12-5

5. Click to select one sample or hold the Ctrl key down while you select
multiple samples.
6. Click Next.
The eConsult wizard (2) screen appears allowing you to enter clinical data
and contact information.

Figure 12-3, eConsult wizard (2)- Clinical and contact form screen
7. Complete the desired fields:

Field Description

Gender Select Male or Female.

Age Type the age of the patient in years.

Weight Kg, Pounds a. Type the patient’s weight.Select


Kilograms or Pounds.
Temperature Type the patient’s temperature in
celsius.

Procedure type Select the patient procedure type.

Rx Administered a. Select each drug that the patient


received for this procedure.
b. Type the dose given to the patient in
the Dose field that displays.
Note: If you selected Other, type the
drug name in the field that displays.
Bleeding status Click the option that indicates whether
the patient is currently Bleeding, Not
bleeding, or Oozing.

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12-6 Communicating TEG Data

Field Description
Lab results Type the available lab results for the
following in their respective fields:
Platelet number
Fibrinogen level
PT
INR
PTT
DDIMER

Comments Type any relevant comments.

Contact phone number Type the phone number of the person to


contact for more information about this
patient.

Contact name and/or Type the name and/ or extension of the


extension person to contact for more information
about this patient.

8. Click Next.
The eConsult wizard (3) screen appears allowing you to select the format
for sending the data.

Figure 12-4, eConsult wizard (3) - Records to send screen


9. Choose the type of records that you want to send:

If you want to send... Select...

Numeric and tracing data for the Samples with tracings


selected sample(s)

Numeric data with tracings Samples with tracings and


overlaying each other Superimpose tracings
(superimposed)

Numeric and tracing data Samples with tracings and, if


according to the length of time that appropriate, Superimpose
the sample ran tracings
From the drop-down list, select
the desired number of minutes
for each tracing.
Note: The user may truncate
the sample so that it fits better
on the recipient screen.

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Communicating TEG Data 12-7

If you want to send... Select...

Selected tracings in the TEG Database


database format so the recipient Note: The recipient must have
can merge and manipulate the TAS installed to open this file.
data.

10. Click Next.


The eConsult wizard (4) screen appears allowing you to select the
recipient.

Figure 12-5, eConsult wizard (4) - Recipient listing screen


11. Select the recipient to receive the transmission and click Finish. When the
transmission is complete, a confirmation message appears.
12. Give the recipient the code that identifies this patient’s information.

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12-8 Communicating TEG Data

USING THE CAPTURE FUNCTION


This section explains how to use the Capture feature to electronically copy and
paste tracings into another document.

Before You Begin


Before you begin, you must have:
⚫ TAS Main screen displayed

The Steps
To copy and paste a tracing into another document:
1. From the TAS Main screen, do one of the following:

If you want to copy... Then...

A single tracing Select the tracing you want.

A superimposed or offset view a. On the toolbar, click Multi and


of multiple tracings select the tracings you want.
b. Click Done.
c. To display a superimposed view
of the tracings, click Super.
Otherwise, continue at step 2.

2. Click . The Capture options screen appears.

Figure 12-6, Capture options screen

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Communicating TEG Data 12-9

3. Select the appropriate options:

If you want to capture... Then select...

First 10 parameters displayed on the tracing Results

No test results on the tracing No results

Grid lines on the tracing Grid lines

No grid lines on the tracing No grid lines

White tracing with a black background Black background

Black tracing with a white background White background

Patient name on the tracing Show patient name

No patient name on the tracing Suppress patient name

4. Click OK. The tracing is stored on the program’s clip board.


The Capture options screen closes and you are returned to the TAS Main
screen.
5. In the document that you want to paste the tracing(s) into, choose Edit >
Paste or press Ctrl+V to paste the tracing(s). In the following example, a
single tracing was captured with the following options selected in the
Capture options screen:
⚫ Results
⚫ Grid lines
⚫ Black background
⚫ Suppress patient name

Figure 12-7, Tracing pasted into a document using the Capture function

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Appendix A

Troubleshooting
TROUBLESHOOTING ........................................................... A-2
Login errors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-3
Database errors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-7
eTest errors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-9
Cup and pin errors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-11
Quality control (Level I and Level II) sample errors . . . . . . . . . . . . . . . . A-12
Unexpected tracing results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-16
Blood sample errors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-19
Temperature errors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-20
Reference ranges errors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-21
Remote workstation access errors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-22
Printing errors. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-23
Accessing Help errors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-26

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A-2 Troubleshooting

TROUBLESHOOTING
This chapter contains troubleshooting tips for some of the most common issues
and concerns experienced when using the TEG® analyzer. This chapter helps you
solve problems associated with:
⚫ Logging in to the TEG Analytical Software (TAS)
⚫ Opening databases
⚫ Performing an eTest
⚫ Loading and ejecting cups and pins
⚫ Running quality control samples
⚫ Unexpected tracing results
⚫ Running blood samples
⚫ Temperature readouts
⚫ Viewing reference ranges
⚫ Accessing remote workstations
⚫ Printing
If a problem still exists after following the recommended actions outlined in the
tables in this chapter, contact TEG System Technical Support to arrange for
repairs or return (refer to “Customer Service” on page 1-4).

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Troubleshooting A-3

Login errors

Problem Possible cause Recommended action


The password does not work. The password is case sensitive. Check that the keyboard Caps
Lock key is not on.
The password has changed. Contact your Site Administrator
for the new password.
When logging in, the following The cfg.set file on the user’s Contact your IT department to do
messages appear: ”This file is either computer is read only. the following:
opened exclusively by another user
or is Read Only …” followed by 1. In Windows® Explorer,
“The config file could not be navigate to the application
opened…” folder (e.g., C:\Program
Files\TEGV4).
2. Locate the cfg.set file, right-
click it, and select Properties.
3. In the Properties dialog, on
the General tab, make sure
the Read only checkbox is not
selected.
You do not have the correct Contact your IT department to set
permissions. your permissions on the
application folder (e.g.,
C:\Program Files\TEGV4) to
Read, Write, and Modify.

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A-4 Troubleshooting

Problem Possible cause Recommended action


When the Patient database is The Patient database is read only. Contact your IT department to do
selected, the message, “This file is the following:
either opened exclusively by
another user or is “Read Only …” 1. In Windows® Explorer,
appears. navigate to the folder (e.g.,
C:\TEG) that contains the
database you want to open.
2. Right-click the database file,
and select Properties.
3. In the Properties screen, on
the General tab, make sure
the Read only checkbox is not
selected.
You do not have the correct Contact your IT department to set
permissions. your permissions on the
application folder (e.g.,
C:\Program Files\TEGV4) to
Read, Write, and Modify.
You are attempting to run the Contact your IT department to do
database from a CD or other the following:
media that is write-protected.
1. Copy the database from the
media to the desktop.
2. In Windows® Explorer, right-
click the database file on the
desktop, and select
Properties.
3. In the Properties screen, on
the General tab, make sure
the Read only checkbox is not
selected.
When logging in, a Patient The database is unavailable. On a network, make sure the
database name message, “does not network connections are secure
exist” appears. and the network is running
properly.
If it is a local database, type the
full path in the Login screen
instead of just the database name.
Contact your IT department if
necessary.
Cannot access a QC database. The QC database is unavailable. On a network, make sure the
network connections are secure
and the network is running
properly.
If it is a local database, type the
full path in the Login screen
instead of just the database name.
Contact your IT department if
necessary.

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Troubleshooting A-5

Problem Possible cause Recommended action


Cannot create a new QC or Patient You attempted to create a new Create the QC database on a
database. QC database from the remote computer where the TEG-enabled
version of the software. software is installed.
The computer may not be Check that the computer is
connected to the network. connected.
You attempted to enter an invalid Type the full path making sure to
path. include the server name.
The Site Administrator may not Contact your Site Administrator
have granted you permission to and check whether you are
create a database. allowed to create a new
database.
Unable to find the database using The “Find” process only works if Select another drive at the top of
the “Find” button. the database is on the drive the Find screen.
selected at the top of the “Find”
screen. If the database is on a
different drive, or over the
network, the “Find” function will
not locate the database.
The Find process does not work if Do one of the following:
the drive that you selected in the
Find screen is named. For ⚫ Use the Windows® search
example, instead of “C:”, the functionality to search for files
drive is named “C: [OS].” named “*.teg” or “*.qc”.
⚫ Contact your IT department to
clear the name associated with
the C: drive.
My personal settings are not The cursor is still in the User Move the cursor out of the User
appearing after I selected my User name field (you did not click or name field by clicking
name. tab out of the field). somewhere else on the Login
screen or pressing Tab. Your
default settings will then display
in the screen.
After selecting the user and You modified the database text Click Locate to select the
pressing Tab, the default patients field before selecting the user. database(s) you want or exit TAS,
(or QC) database did not load. This disables the default entry. log in again, and select a user
without modifying any fields.

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A-6 Troubleshooting

Problem Possible cause Recommended action


When attempting to access the Another program or driver is using 1. Verify that no other instance
TEG screen, a message appears the COM port such as a palm of TAS is running and that the
indicating that the COM port is in pilot or touch screen. Any computer is restarted.
use, or does not exist. software or driver that uses a
COM port could cause this 2. Contact your Site
message to be issued. Administrator to check to see
if any new programs or drivers
were loaded since the last
time TAS was run.
3. Your Site Administrator can
complete the appropriate
action:
⚫ Use a different port for TAS.
⚫ Use a different port for the
software causing the
problem.
⚫ Uninstall the problem
software.
The wrong COM port was Check that the correct COM port
selected in the configuration was selected in the configuration
utility. utility.
A 4.1 database has been When a 4.1 database is opened in You can access a backup of the
accidentally converted to version version 4.2, it is automatically 4.1 database. A backup is
4.2. converted to version 4.2. automatically created when an
older version database is
converted to 4.2. By default, this
backup is created in the
C:\TEG\BackupV4 folder.
Unable to log in as the Site Site Administrator password is Contact TEG System Technical
Administrator because the Site unknown. Support.
Administrator is unavailable.
Unable to log into the The password is case sensitive. Check that the keyboard Caps
configuration utility. Lock key is not on.
The Site Administrator password Contact your Site Administrator to
was changed. obtain the new password.

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Troubleshooting A-7

Database errors

Problem Possible cause Recommended action


When opening a database, or when The database may be corrupted. Do the following:
scrolling, the message “Object or 1. Exit the patient database,
With Block variable not set” make a copy/backup of the
appears. problem database, and then
OR compact the original problem
When opening a database, the database (refer to Chapter 9,
message, “Search key not found” Managing Databases).
appears. 2. Enter the database and check
OR to make sure that no data was
lost.
While scrolling down or up, the
same patient name stays in the top 3. If data was lost, delete the
sample’s slot. compacted database, and
restore the copy/backup that
OR you made.
The message, “Unrecognized
database format” appears. 4. Create a new database, and
merge the problem database
OR into the new database.
The message, “Disk or Network” 5. Repeat the process for the QC
appears when the network database.
connections are sound and the
database is stored locally.
Tracings or test values disappear The database may be corrupted. Refer to the row above for
from a database. instructions on compacting the
database.
Samples were deleted from the Torestore an earlier version of the
database. database but preserve samples
that have been run since the last
backup:
1. Obtain an earlier backup copy
of the database from your
backup location and rename
the file.
2. Copy the renamed backup
database to your current
database location.
3. Merge the backup database
into the current database.
4. Remove the backup database
after the merge.

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A-8 Troubleshooting

Problem Possible cause Recommended action


After compacting, the tracings or Possible corruption. Do the following:
test results are missing. 1.In TAS, create a new database.
2.Choose File > Merge and
navigate to the backup
database that you created
before compacting.
3. Click Open.
4. After merging, make sure the
data is restored.
After compacting, all the data is Possible corruption. Do the following:
lost from a database. 1.In TAS, create a new database.
2.Choose File > Merge and
navigate to the backup
database that you created
before compacting.
3. Click Open.
4. After merging, make sure the
data is restored.
When exiting the Edit Case screen, Known system error. In TAS, select Options > User
a gray screen appears. Profile Setup, then exit the User
profile setup screen.
No changes are required in the
User profile setup screen.
During compacting, a message A temporary file from a previous Delete the temporary file, “teg
appears indicating that compacting compacting action still exists. compact.tmp”, located by default
cannot be completed. (Windows 2000 and XP) in
C:\Program Files\TEGV4.
An excluded sample type is staying The database contains samples Consider the following:
included. with the same sample type as the ⚫ Remove the samples that have
one you are trying to exclude. the sample type you want to
exclude.
OR
⚫ Change the sample type for
those samples that you want to
exclude.
OR
⚫ Create a new database

You attempted to exclude an L1 or You cannot exclude an L1 or L2


L2 sample type. sample type.

06-510-US, Manual revision: AD TEG® 5000 System User Manual


Troubleshooting A-9

eTest errors

Problem Possible cause Recommended action


When performing an eTest, the Data is still processing. Give the software a little more
“Channel not at equilibrium” time to process the data, or click
message appears. eTest again.
The analyzer is picking up Check that the analyzer is on a
external vibrations. secure surface that is not being
exposed to any vibrations.
When performing an eTest, the The lever is in load. Move the lever to “Test” and click
“eTest value off center” message eTest again.
appears.
The analyzer is not level. Use the bubble level at the top of
the analyzer to ensure the
analyzer is level.
The eTest is off center. Adjust the corresponding “BASE”
potentiometer in the back of the
analyzer (refer to “Adjusting the
eTest Baseline” on page 7-8).
While running samples, the The eTest may be out of range. End the sample, perform the
following message appears: eTest, and make any necessary
“An eTest-out-of-range error has adjustments.
occurred on channel <#>. This The wrong channel was started. End the sample on the channel
error may be due to: 1. A true eTest you accidentally started, and re-
error or 2. Misloading of the run the sample.
disposables.”
The cup and pin are not loaded Make sure the cup and pin are
properly. pushed firmly into place (refer to
“Loading and Ejecting Cups and
Pins” on page 7-14).
After adjusting the eTest values, the The message does not update to Highlight the channel you are
message did not change to reflect reflect any change in the eTest using and click the eTest button
the new MIN and MAX numbers. status until the eTest is run again. again.
The eTest results are not saved. The “Service mode” option may In the Maintenance screen, clear
be checked on the Maintenance the service mode checkbox.
screen.

TEG® 5000 System User Manual P/N 06-510-US, Manual revision: AD


A-10 Troubleshooting

Problem Possible cause Recommended action


An eTest result did not appear on a The Service mode option may be In the Maintenance screen, clear
report. checked on the Maintenance the Service mode checkbox.
screen.
The data for each day appears on Check each page of the report.
its own report page. Data for two
days has at least two pages, even
if each page only has one line of
data.
TAS is being run on the Windows No workaround is available.
7 operating system.On Windows
7, eTest results do not always Although the eTest value may not
appear on the Service History Log appear on the report, it is stored
and Daily Maintenance Log in the software and recalculated
reports. each time a test is started. If the
newly calculated eTest value is
out of range, an alert warns that
the date may be compromised.
The serial number for the analyzer The Service mode option may be Do the following:
being tested does not display on checked on the Maintenance
1. In the Maintenance screen,
the Daily Maintenance Log report. screen or the final results have not
been saved. clear the Service mode
checkbox.
2. Click eTest and wait for a final
message such as “eTest OK”
or “eTest out of range.”

06-510-US, Manual revision: AD TEG® 5000 System User Manual


Troubleshooting A-11

Cup and pin errors

Problem Possible cause Recommended action


The pin sometimes slips down into The pin is not loaded securely. Make sure the pin is pushed
the cup. firmly into place, using the plastic
pusher at the bottom of the carrier
while applying counter pressure
on top of the analyzer (refer to
“Loading and Ejecting Cups and
Pins” on page 7-14).
The cup is not flush with the The cup is not fully seated after With an index finger placed
carrier. the pin is pushed up. under the edge of the carrier, seat
the cup by pushing down on it
with both thumbs until the flange
of the cup is touching the top of
the carrier.
The pin will not come off the The lever is not in the Eject Press the lever down to the Eject
skewer. position. position and the pin should
automatically drop off the skewer.
If necessary, you can remove the
pin manually while the lever is in
the Load position.
The cup does not easily come out The cupwell in the carrier may be Do the following:
of the carrier. dirty.
1. Push the carrier firmly against
the tray, then lift the cup out
of the carrier.
If necessary, you can lift the
cup out of the cupwell using
bent tip tweezers or a
hemostat.
2. Clean the cupwell (refer to
“Cleaning The TEG Analyzer”
on page 7-28).

TEG® 5000 System User Manual P/N 06-510-US, Manual revision: AD


A-12 Troubleshooting

Quality control (Level I and Level II) sample errors

Problem Possible cause Recommended action


The quality control samples are The database was closed and all From the TAS Main screen menu,
missing. the QC samples were transferred choose QC > Go To to open the
to the QC database. QC database.
The software is configured to From the TAS Main screen menu,
transfer the samples after they choose QC > Go To to check if
terminate, so it is possible that the the samples transferred.
samples transferred without the
database being closed.
When trying to enter a new lot The sample type was not set to L1 From the TAS screen, go to the
number the screen to enter a new or L2. sample type (ST) field and select
patient appears. either L1 or L2, whichever is
appropriate.
One or more parameters are out of Consider the following common Do the following:
range. causes:
1. Check the temperature (refer
⚫ Hardware problems. to “Temperature errors” on
⚫ Quality control sample page A-20).
problems. 2. Ensure the analyzer is level.
⚫ Operator error. 3.Rerun the control sample:
⚫ Make sure the cups and
pins are loaded correctly
(refer to “Loading and
Ejecting Cups and Pins” on
page 7-14), avoiding
contamination of their
surfaces.
⚫ Reconstitute a new vial of
quality control material,
carefully following the
instructions on the product
insert.
⚫ After the quality control
material is added to the
cup, raise the carriers
immediately but not too
quickly. This will ensure
that no material gets
splashed onto the flange of
the cup.
4.If a problem still exists,
contact TEG System Technical
Support.

06-510-US, Manual revision: AD TEG® 5000 System User Manual


Troubleshooting A-13

Problem Possible cause Recommended action


Elongated R time. The analyzer is out of Contact TEG System Technical
specification. Support.
The carrier is not raised. Make sure the carrier is fully raised.

Calcium and or/activator were Prepare another sample and rerun


pipetted or reconstituted the test.
incorrectly or are contaminated.
The cup/and or pin were loaded Make sure the cup and pin are
incorrectly. pushed firmly into place (refer to
“Loading and Ejecting Cups and
Pins” on page 7-14).
The sample temperature is Check the temperature (refer to
incorrect. “Temperature errors” on page A-
20).
Shortened R time. Pipetting was inaccurate and/or Prepare another sample and rerun
the sample was prematurely the test.
activated.
The sample temperature is Check the temperature (refer to
incorrect. “Temperature errors” on page A-
20).

K is out of range. Calcium and or/activator were Prepare another sample and rerun
dispensed incorrectly or are the test.
contaminated.
The sample temperature is Check the temperature (refer to
incorrect. “Temperature errors” on page A-
20).

Angle is out of range. The analyzer is out of Contact TEG System Technical
specification. Support.
There was an electrical disruption Rerun the test.
to the analyzer.
The sample temperature is Check the temperature (refer to
incorrect. “Temperature errors” on page A-
20).

TEG® 5000 System User Manual P/N 06-510-US, Manual revision: AD


A-14 Troubleshooting

Problem Possible cause Recommended action


MA is out of range. The analyzer is out of Contact TEG System Technical
specification. Support.
The carrier is not flush with the Ensure that the carrier is fully
lower column. raised.
The cup and/or pin were loaded Make sure the cup and pin are
incorrectly. pushed firmly into place (refer to
“Loading and Ejecting Cups and
Pins” on page 7-14).
The analyzer is not level. Use the bubble level at the top of
the analyzer and the leveling feet
to ensure that the analyzer is
level.
There is excess calcium chloride Consider using a fresh pipette tip
on the pipette tip. for each cup.
MA in one channel is out of range The analyzer is out of Contact TEG System Technical
after running multiple control specification. Support.
samples.
The MA in both channels is either The analyzer is not level. Use the bubble level and the
low or high. leveling feet to ensure the
analyzer is level.
R and Angle are out of range, MA is The sample temperature is Check the temperature (refer to
within limits. incorrect. “Temperature errors” on page A-
20).

R in one channel is very short and The analyzer is not level. Use the bubble level at the top of
the MA is very large, while the MA the analyzer and the leveling feet
in the other channel is very small. to ensure that the analyzer is
level.
Parameter values are out of range For R and K, TAS may be reporting Convert the mm to minutes,
according to the insert, but not the units in millimeters (mm) and remembering that 2mm=1
according to the software. the insert reports the units in minute.
minutes or seconds. Convert the mm to seconds if this
is the protocol at your site.
You may have used a new lot that Enter the current reference ranges
has different reference ranges. from the product insert into TAS.
Unexpected tracing for Level I. Level I control was placed in the Do the following:
sample cup but “L2” was selected
as the sample type in the software. 1. Confirm that the wrong
sample type was selected in
the software.
2. Select the correct sample type.

06-510-US, Manual revision: AD TEG® 5000 System User Manual


Troubleshooting A-15

Problem Possible cause Recommended action


Unexpected tracing for Level II. Level II control was placed in the Do the following:
sample cup but “L1” was selected 1. Confirm that the wrong
as the sample type in the software. sample type was selected in
the software.
2. Select the correct sample type.

TEG® 5000 System User Manual P/N 06-510-US, Manual revision: AD


A-16 Troubleshooting

Unexpected tracing results

Problem Possible Cause Recommended Action


Straight line tracings. There is no communication 1. Turn on the TEG analyzer.
between the analyzer and the
computer. 2. Make sure that at least one
analyzer is plugged into the
TEG 1 port on the A/D box and
that additional analyzers are
plugged into their correct
ports (TEG 2, 3, or 4).
3. Make sure that the power light
on the A/D box is on.
4. Tighten any loose connections
between the analyzer and the
A/D box or between the A/D
box and the computer.
The A/D box is connected to the Make sure the A/D box is
computer through a USB/serial connected through the COM
converter. port.
The A/D box is connected to the Do the following:
wrong COM port. 1. From the TAS Main screen
menu, choose Options >
User Profile Setup.
2. On the Software tab, under
COM port, select the
corresponding port from the
Select COM port drop-down
list.
3. Click Done.

The incorrect channel was started. Start the correct channel.


The motor is not on. Turn on the motor.
Note: This applies only to older
TEG analyzers with a motor switch
that can be turned on or off
independently of the power
switch.
The sample was not prepared Consider the following:
correctly. ⚫ If heparin is suspected, ensure
a blue heparinase cup is used.
⚫ Ensure 20 µL calcium chloride
is added to a sodium citrate
sample.
⚫ Ensure 20 µL calcium chloride
is added to a quality control
sample.

06-510-US, Manual revision: AD TEG® 5000 System User Manual


Troubleshooting A-17

Problem Possible Cause Recommended Action


Unusual dips and spikes in Loose pin. Stop the sample, reload a new
tracings. cup and pin, and rerun the
sample.

Loose cup and pin. Stop the sample, reload a new


cup and pin, and rerun the
sample.

Data from the A/D box was Do the following:


interrupted.
1. Make sure that all cable
connections are secure and
that cables are not bent or
kinked.
2. Go to the Windows® Control
Panel, select Power Options,
and make sure that all settings
are set to Never.
The A/D box is connected to the Make sure the A/D box is
computer through a USB/serial connected through the COM
converter. port.
Unstable environment/vibrations. Make sure the analyzer is in a
low vibration environment.
The analyzer was bumped during Prepare another sample and
the sample run. rerun the test, making sure the
analyzer is not bumped during
the sample run.

TEG® 5000 System User Manual P/N 06-510-US, Manual revision: AD


A-18 Troubleshooting

Problem Possible Cause Recommended Action


Double R: Angle not calculated Unstable environment/vibrations. Make sure the analyzer is in a
from the split point (SP). low vibration environment.
The tracing below illustrates a Make sure the analyzer is not
double R. The Angle is incorrectly bumped during the sample run.
measured from the start of the
double R (A) instead of from the An electrical surge occurred within Make sure the analyzer is
split point (B). the circuit (e.g., a refrigerator or air plugged into a UPS
conditioning unit cycled on and (Uninterruptible Power Supply)
off). unit.
Isolate the analyzer on its own
electrical circuit.
The analyzer is not level and the Make sure the analyzer is level.
pin is touching the side of the cup.
The gap or alignment is out of Contact TEG System Technical
specification and the pin is Support.
touching the bottom or side of the
cup.

Sharp drop in MA. The lever was switched to Load If needed parameters were not
before terminating the sample. defined, rerun the test.

No R value. A preclot. There may have been a Prepare another sample and
clot in the sample or there may rerun the test.
have been a delay in starting the
sample.

06-510-US, Manual revision: AD TEG® 5000 System User Manual


Troubleshooting A-19

Blood sample errors

Problem Possible cause Recommended action


Unable to start samples from the You must be in the TEG screen to From the TAS Main screen, click
TAS Main screen. run samples. the TEG icon to display the TEG
screen.
Unable to access the TEG screen. You attempted to access the TEG You must be using the TEG-
screen from the remote version of enabled version of the software to
the software. access the TEG screen.
Unable to change information for You attempted to change Go to the computer that started
active samples. information for an active sample the sample and make the change
from a computer other than the from that computer.
one used to start the sample.
The “Select a patient” screen You attempted to terminate a Click the appropriate button:
appears when terminating samples. sample before selecting a patient. ⚫ Done to assign the selected
patient to the sample.
⚫ Create to display the Patient
Creation screen.
⚫ Ignore to assign the current
time and date as the patient
name to the sample.
Notes:
⚫ Ignore is meant to be
temporary, until you can
create and assign the
correct patient name.
⚫ Ignore is not available if
your Site Administrator
disabled it.
⚫ Cancel to stop the termination
of the sample.
The “Select a patient” screen Your samples are set to automatic Do not click Cancel as it stops the
automatically appears when termination, the criteria has been termination and keeps the sample
running samples. After clicking met, but the sample does not have running.
Cancel, the screen reappears every a patient assigned to it. Either choose a patient now or
few seconds. click Ignore (if available) and
assign a patient to that sample at
a later time.
A spike appeared in the tracing The software was filtering and None.
when the analyzer was bumped, optimizing the last minute of data
but then disappeared. to correct the aberration.
A spike occurred at the end of the The filtering process is still in Allow additional time for the filter
tracing and did not smooth out. progress. to complete.
The sample terminated before the Rerun the sample.
filter corrected.
A spike occurred at the end of the The disturbance lasted longer Rerun the sample.
tracing and did not smooth out, than or was greater than the
even after running for an additional filtering/optimization’s capacity
10 minutes. for correction.

TEG® 5000 System User Manual P/N 06-510-US, Manual revision: AD


A-20 Troubleshooting

Problem Possible cause Recommended action


After running a sample from the The sample did not meet the filter Remove or adjust the filter to
TEG screen and clicking the Done criteria for displaying on the TAS allow for the display of this
button, the sample does not show Main screen. sample.
up on the TAS Main screen.
Samples may be sorted. Locate the sample by the
appropriate sort or sort by date.
After entering the patient name for You attempted to change the Change the sample type to the
a sample and changing the sample sample type to L1 or L2 for a correct patient sample type.
type for a patient in the database, patient that is in the patient
the message “The Lot number was database but not the QC
not found” appears followed by a database.
prompt to create the lot number.
No value is displayed for CI. The sample is a PlateletMapping None.
sample type (A, AA, ADP).
The MA < 20 mm and K is left None.
undefined. CI cannot be
calculated without a value for K.
The sample run was stopped early Let the sample run until there are
and/or values were not achieved values greater than 0 for R, K,
for R, K, Angle, or MA. CI cannot Angle and MA.
be calculated with a 0 value for R,
K, Angle or MA.

Temperature errors

Problem Possible cause Recommended action


The temperature readout is flashing The ribbon cable is loose. Check that the ribbon cable
“BAD.” connections between the carrier
and the analyzer are tight.
The ribbon cable and/or carrier is Clean the carrier and ribbon
dirty. cable with alcohol.
The carrier or ribbon cable is Contact TEG System Technical
damaged or defective. Support.
The temperature is high or there is The ribbon cable is loose. Check that the ribbon cable
a jump in temperature. connections between the carrier
and the analyzer are tight.
The ambient temperature is Make sure that the analyzer is not
fluctuating. in front of a window or by an air
duct.
There is a loose connection inside Contact TEG System Technical
the temperature controller. Support.
The temperature controller is Contact TEG System Technical
defective. Support.

06-510-US, Manual revision: AD TEG® 5000 System User Manual


Troubleshooting A-21

Problem Possible cause Recommended action


The temperature stays at room The ribbon cable is loose. Check that the ribbon cable
temperature and will not heat up to connections between the carrier
37.0 degrees. and the analyzer are tight.
The ribbon cable and/or carrier is Clean the carrier and ribbon
dirty. cable with alcohol.
The carrier or ribbon cable is Contact TEG System Technical
defective. Support.
The temperature controller is Contact TEG System Technical
defective. Support.
The temperature readout is not at The temperature set point was Reset the set point to 37.0
37.0 degrees ± 0.5. changed. degrees.

Reference ranges errors

Problem Possible cause Recommended action


Reference ranges do not appear in The reference ranges do not Select the desired tracing and
the TAS Main screen. display on the TAS Main screen. then click the Max button.
The reference ranges do not appear No sample type was entered for From the TEG screen, select the
in the Max screen. that channel. desired sample type for the
appropriate channel.
No reference ranges were entered Enter the reference ranges.
in TAS for that sample type.
A test is being displayed that does Enter the reference ranges.
not have reference ranges.

TEG® 5000 System User Manual P/N 06-510-US, Manual revision: AD


A-22 Troubleshooting

Remote workstation access errors

Problem Possible cause Recommended action


Unable to run samples in the You cannot run samples in the Install the TEG-enabled version of
remote version of TAS. remote version of TAS. TAS.
When viewing a database over the Another user is trying to access Click “OK” to try again or wait
network, the following error was the same record at the same time. until the other user is done.
issued:
“The file is currently locked. Click
“OK” to try again, or “Cancel” to
terminate the program. “
The database cannot be accessed The database drive is not shared Contact your Site Administrator.
over the network. and accessible.
The network is down.
You do not have the correct Contact your Site Administrator to
permissions. set your permissions on the
application folder (e.g.,
C:\Program Files\TEGV4) to
Read, Write, and Modify.
When accessing a database over TAS is refreshing. Your screen None.
the network, the screen flickers refreshes every 30 seconds while
periodically. a sample is running or when you
make a change to the database.
When accessing a database over You attempted to modify active Go to the computer running the
the network, you are unable to samples from a computer other sample(s) and make the change.
change the sample description of than the one running the samples.
any active sample. You can modify active samples
only from the computer running
the samples.
When remotely viewing a Another user may have deleted None.
database, a sample disappeared the sample.
after TAS refreshed.
A filter may be set that precludes Change the filter criteria to
this sample from displaying on the include this sample (e.g., if the
TAS Main screen. sample is terminated, undo the
Active filter).
The patient name for a sample was Another user may be updating this Try updating at a later time.
changed over the network, but field.
when TAS refreshed, the sample
still had the old name.

06-510-US, Manual revision: AD TEG® 5000 System User Manual


Troubleshooting A-23

Printing errors

Problem Possible cause Recommended action


When trying to print, the following The database may be corrupted. Do the following:
message appears: “This database 1. Exit the patient database,
has too many users printing on it, make a copy/backup of the
or is damaged.” problem database, and then
compact the original problem
database.
2. Enter the database and check
to make sure that no data was
lost.
3. If data was lost, delete the
compacted database, and
restore the copy/backup that
you made.
4. Create a new database, and
merge the problem database
into the new database.
5. Repeat the process for the QC
database.
When trying to print, a message No default printer is set. Contact your Site Administrator.
appears saying that a printer needs
to be loaded on the computer.

When trying to use Quick Print, the No tracing is selected. Highlight the tracing you want to
Print button is disabled. print and click the Quick Print
button.
You attempted to print from the Press the F6 key to send the
Multi screen which has the Print tracing to the default printer.
button disabled.
When using Quick Print, the This is according to design. Press the F6 key to send the
printer must be selected, even tracing to the default printer.
though the default printer is
selected already.
All pages of the report print, You did not specify a particular When you choose the printer,
instead of the current page. subset or page. indicate the page(s) that you want
to print.

TEG® 5000 System User Manual P/N 06-510-US, Manual revision: AD


A-24 Troubleshooting

Problem Possible cause Recommended action


The Maintenance report does not The Service mode checkbox is Do the following:
display today’s results. selected on the Maintenance 1. In the Maintenance screen,
screen. clear the Service mode
checkbox and run the
maintenance test again.
Any maintenance tests that
were run with the Service
mode box selected will not
be retained or stored in the
database.
2. Run the Maintenance report
again.
A filter may be set that precludes Change the filter to include
including today’s results. You may today’s results.
have chosen to filter by date and
excluded today.
The data is not on the first page of Check all pages of the report.
the report.
Values are missing from the printed You attempted to print test results Do the following when printing
report. that are not in the designated 10 the report:
default tests to print.
1. In TAS, click Report.
2. In the Report options screen,
under Numeric options, select
All tests.

06-510-US, Manual revision: AD TEG® 5000 System User Manual


Troubleshooting A-25

Problem Possible cause Recommended action


When trying to print, a message The database program creates an Do the following:
appears indicating that a table (in .ldb file that controls which
1. In TAS, open a different
the database) cannot be locked records need to be locked for database than the one you
because another user is accessing editing. In this situation, the were trying to print from.
it, and that the database database did not get released from
compacting utility needs to be run. the lock to allow other processes, 2. Run the compact utility on the
such as printing, to access it. database you were trying to
print from.
3. Try printing again. If the same
message appears, contact your
IT department to do the
following:
a. Exit the program and make
sure that no one else is
accessing that database.
b. Using Windows® Explorer,
navigate to the folder (e.g.,
C:\TEG) that contains the
problem database.
c. Find the file that has the
same name as the database
but with the extension
“.ldb” (e.g., “Patients.ldb”).
d. Select and delete the .ldb
file.
Caution: Do not delete any
file with the extension
“.teg” or “.qc”
Nothing happens when trying to If you are trying to print over the Check the status of the printer as
print. network, the network may be well as the network.
down.
You may lack the correct Check the permissions to print on
permissions to print on the the hosting computer or contact
hosting computer. your network administrator.
When trying to print a tracing by The printer default is set to print Contact your Site Administrator to
pressing F6, more than one copy more than one copy. set the printer default to print one
prints. copy only.

TEG® 5000 System User Manual P/N 06-510-US, Manual revision: AD


A-26 Troubleshooting

Accessing Help errors

Problem Possible cause Recommended action


When clicking the Help or More TAS is being run on the Windows Contact your IT department to do
Info button, the Help file doesn’t 7 operating system which doesn’t the following:
open. support Windows XP Help files. 1.On the Microsoft download
website, search for
“WinHlp32.exe.”
2.Follow the instructions to
download the free WinHelp32
application.
When opening a PDF file on the Your version of Adobe Acrobat is Do one of the following:
Help menu (e.g., choosing Help > 5.0 or lower. ⚫ In the Program Compatibility
Help Topics), a Program Assistant message, click Run
Compatibility Assistant message Program. The file opens as
appears. expected.
⚫ Download the free Adobe
Reader, version 8 or higher.

06-510-US, Manual revision: AD TEG® 5000 System User Manual


Appendix B

Specifications and Performance


Characteristics
SPECIFICATIONS ................................................................ B-2
Physical Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-2
Environmental Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-2
Electrical Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-3
LIMITATIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-4
Sensitivity factors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-4
Interference factors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-4
PERFORMANCE CHARACTERISTICS. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-6
Accuracy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-6
Precision . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-7
Sensitivity and specificity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-8
Reference ranges . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-8

TEG® 5000 System User Manual P/N 06-510-US, Manual revision: AD


B-2 Specifications and Performance Characteristics

SPECIFICATIONS
This section describes the physical, environmental, and electrical specifications
for storing and operating the TEG® analyzer.

Note: For additional information about sensitivity and interference factors, refer
to “Limitations” on page B-4.

Physical The physical specifications of the TEG analyzer are as follows:


Specifications
Characteristics Values
Dimensions 11.6 in (29.5 cm) high x 10 in (25.5 cm) deep x 7.7
in (19.5 cm) wide.
Weight 11.2 lb (5.08kg)
Channels 2 independent measuring channels
Cup drive Line-synchronized, with synchronous motor
Temperature control Individual temperature control for each channel
Measuring technique Shear elasticity of a coagulating sample, determined
by motion of pin
Transducer Electrical-mechanical transducer of movement of
torsion wire connected to the suspended pin
Sample volume 360 µL
Initial warm-up time Less then 5 minutes to warm sample
Operating position Level adjusted by leveling feet and level

Table B-1, Physical specifications

Environmental The environmental specifications for the operation and storage of the TEG
Specifications analyzer are as follows:

Conditions Value
Use Indoor use
Operating position Vibration-free; no solar radiation
Operating temperature 50 °F to 95 °F (10 °C to 35 °C)
Operating humidity Relative humidity 20-80% (non-condensing)

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Specifications and Performance Characteristics B-3

Conditions Value
Transport and storage –22 °F to 122 °F (–30 °C to 50 °C)
temperature
Transport and storage Relative humidity 5-95% (non-condensing)
humidity
Pollution degree Pollution degree 2

Table B-2, Environmental specifications

Electrical The electrical specifications for operating the TEG analyzer are as follows:
Specifications
Characteristics Value
Power Power supply in protection class I, transformer
with thermal cutoff and monitored safety
insulation.
Power supply must be plugged into a properly
grounded outlet.
Power the device using only the power
adapter supplied by Haemonetics for the
TEG analyzer.
Use an Uninterruptible Power Supply (UPS) unit
between the analyzer and the power source.
Overvoltage Overvoltage Category II
Mains supply fluctuations Not to exceed ±10% of the nominal voltage
220V model Operating voltage 230V, 50 Hz,
rated current 0.20 A,
max input power 46W.
Thermal cutout and 1 A 2AG type Slo-Blo fuse
provided.
120V model Operating voltage 120V, 60 Hz,
rated current 0.38 A,
max input power 46W.
Thermal cutout and 1 A PICO II, Very Fast-Acting
fuse provided.
TEG 5000 Input power rating (from power supply) 24 VAC
30 W

Table B-3, Electrical specifications

Note: For more information about electrical precautions, refer to “Power outlet
connection” on page 3-3.

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B-4 Specifications and Performance Characteristics

LIMITATIONS
Caution: The TEG analyzer is for in vitro diagnostic use only.

Users of the TEG analyzer should be properly trained and should be appropriate
medical or other health care professionals.
The TEG analyzer output is for presentation purposes only, and may vary from
time to time; users should use the actual data derived from their own samples and
their own established reference ranges to quantify the output tracing as to the
degree of abnormality.
Results from the TEG analyzer should not be the sole basis for a patient diagnosis
but should be considered along with the patient’s clinical condition and other
laboratory tests.

Sensitivity factors Sensitivity factors that may affect the measurement capability and operation of
the TEG analyzer are listed below.
⚫ The maximum oscillation of the cup in the TEG instrument is
approximately 5 degrees, as described in the Interference section below.
Therefore, the maximum amplitude (MA parameter) cannot be measured
beyond 96 mm. It is very rare for human blood to exceed this limit; if it
should happen, the diagnosis is obvious-extreme hypercoagulability.
⚫ The eTest value of the TEG instrument determines the zero starting point of
the graphical output tracing. Therefore, out of range conditions may
prevent the TEG graph from reaching its maximum amplitude (the MA
parameter may not reach its maximum value). The software issues a
warning if the eTest value is out of range when a sample is started.
⚫ Non-anticoagulated whole blood samples that are placed on the analyzer
later than six minutes after drawing may result in a clotted sample, leading
to erroneous results.
⚫ Testing sensitivity of the TEG analyzer is affected if the environmental and
electrical specifications referenced in Table B-2 and Table B-3 are not met.

Interference Interference factors that may affect the performance or sensitivity of the TEG
factors analyzer are listed below along with information on ways to mitigate the
interference:
⚫ The moving part of the TEG analyzer is a cylindrical cup that oscillates
very slowly through an angle of approximately 5 degrees. This means the
following:
⚫ The TEG analyzer must be level. A leveling bubble and leveling feet are
built into the instrument.

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Specifications and Performance Characteristics B-5

⚫ The TEG analyzer is sensitive to vibration and must be set up so that


vibrations and jolting are avoided.
⚫ The analog signal generated by the oscillating pin is converted (by an
analog to digital board) at the rate of 10 samples per second. The digitized
data is continuously transmitted to the software via a serial port (either
COM1 or COM2). Therefore, any communication interference with these
ports should be eliminated, and all sleep modes and screen and power
savers should be disabled.
⚫ The TEG analyzer analysis is very sensitive to anticoagulants, especially
heparin. In the clinical setting, to prevent blood activation, most of the
tubes (such as catheter lines) and extra-corporeal surfaces are coated with
heparin, which occasionally is released into the blood stream in very small
quantities, and results in heparin-contaminated samples being analyzed
by the TEG instrument. Therefore, it is imperative to use heparinase (such
as lyophilized heparinase cups) to eliminate heparin contamination.
⚫ When the TEG analyzer is being used at a point-of-care site, the standard
mode of operation is to draw a blood sample that is immediately placed in
the TEG cup for analysis without being anti-coagulated.
Because the clotting process begins as soon as the blood is drawn, a
constant time interval for sample application onto the analyzer (e.g., four
minutes) should be used to eliminate biases due to different time intervals
in placing the blood in the TEG cup.

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B-6 Specifications and Performance Characteristics

PERFORMANCE CHARACTERISTICS
Through performance testing, the accuracy and precision of the TEG 5000 Series
analyzer is supported. In addition, Haemonetics has identified reference ranges
as well as factors that may affect the measurement capability, performance, and
sensitivity of the analyzer.
A summary of the accuracy, precision, sensitivity, and reference range
characteristics for the TEG 5000 analyzer are discussed below.

Accuracy To demonstrate the TEG analyzer measurement accuracy, Haemonetics


conducted an evaluation comparing the sample measurement performance of
the TEG 5000 series analyzer against the TEG 3000 series analyzer.
Forty (40) lyophilized plasma samples were prepared for analysis following
procedures in the TEG User Manual. Blood from each sample was placed
simultaneously into a calibrated 5000 series TEG analyzer and a calibrated 3000
series TEG analyzer. The samples were then run simultaneously at 37 °C,
following steps outlined in the User Manual and using the same TEG Analytical
Software.
The following four parameters, which are collected during routine TEG analyzer
use, were determined for each sample run:

Parameter Description

R (mm) Time (minutes or seconds) to onset of coagulation

K (mm) Time (minutes or seconds) to a standard clot


strength (20 mm amplitude)

MA (mm) Maximum clot strength (mm amplitude)

Angle (deg) Proportional to the rate of clot growth

Table B-4, Parameters for accuracy testing


Data from the sample runs were analyzed using the Student’s t-test for
independent samples, a statistical test that compares the means of two samples
to test the null hypothesis that they are the same.
The test results demonstrate that the 5000 Series TEG analyzer sample
measurement performance is equivalent to the 3000 Series analyzer. The analysis
shows no statistical significance in the TEG parameters, R, K, MA and Angle,
between the 5000 Series and the 3000 Series results at P < 0.05.

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Specifications and Performance Characteristics B-7

The results are tabulated below, as the means, standard deviations, differences
between the means, standard deviations of the differences, t-values, and the
2- tail probability.

Comparison of means of samples (n=40)

Parameter

R (mm) K (mm) Angle (deg) MA (mm)

5000 Series 11.5625± 2.1500± 73.9625± 30.6250±


(Mean ± SD) 1.178 0.379 2.382 1.036

3000 Series 11.7500± 2.2750± 73.3750± 30.4010±


(Mean ± SD) 1.276 0.423 3.061 1.261

DIFFERENCE 0.1875± 0.1250± 0.5875± 0.2240±


(Mean ± SD) 0.354 0.090 0.613 1.498

T-VALUE .68 1.39 .96 .87

DF 78 78 78 78
2-TAIL P-VALUE 0.497 .168 0.341 0.388

Table B-5, Parameter measurement comparisons

Precision To demonstrate the TEG analyzer measurement precision, Haemonetics


conducted an evaluation using the following activators:
⚫ Silica particles - brand name: Celite; formerly supplied by Haemoscope
⚫ Tissue factor - brand name: Hemoliance; manufactured by Instrumentation
Laboratory Company (ILC)
⚫ Thrombin - brand name: Thrombin (Sigma); manufactured by Sigma
⚫ Kaolin - brand name: DAPTTIN®; manufactured by Immuno
⚫ Kaolin - brand name: Kaolin; supplied by Haemoscope
Following the steps outlined in the TEG User Manual, 10 mL of blood was drawn
from each of five healthy individuals with no known hemostasis problems. Eight
(8) TEG measurements were obtained from each blood sample.
Using four (4) TEG analyzers, measurements were run over the course of two (2)
days; for Haemoscope’s Kaolin, measurements were run over five (5) days.
For each activator, a total of forty (40) measurements were obtained using the
activated samples.

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B-8 Specifications and Performance Characteristics

Based on the TEG measurement data, the precision of each TEG parameter
expressed as a percentage using the coefficient of variation (CV) is as follows for
each activator:

Parameter
Activator
R K Angle MA
Celite 8.7% 7.6% 2.4% 4.1%

Tissue Factor 13.1% 12.9% 2.3% 3.3%

Thrombin 13.2% 13.4% 3.5% 3.8%

Kaolin 12.7% 17% 2.8% 5.0%


(DAPPTIN)

Kaolin 13.4% 4.4% 2.8% 6.3%


(Haemoscope)

Table B-6, Precision of parameters for each activator


These CV values are relatively small in the TEG parameter comparison with other
coagulation instruments, the majority of which are higher.

Sensitivity and Refer to “Limitations” on page B-4 for the following information on sensitivity
specificity and specificity:
⚫ Sensitivity factors that may affect the measurement capability and
operation of the TEG analyzer.
⚫ Interference factors that may affect the performance or sensitivity of the
TEG analyzer and ways to mitigate the interference.

Reference ranges Haemonetics provides reference ranges in the TEG system software which were
derived from data provided by a number of hospitals in the United States.
Reference ranges for native whole blood samples are listed in Chapter 11. Refer
to the appropriate product inserts for the reference ranges for other sample types.

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Appendix C

Glossary
GLOSSARY ....................................................................... C-2

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C-2 Glossary

GLOSSARY

A TEG Activator sample. Constitutes one of the PlateletMapping® assay tests and
is used to produce a clot without platelet contribution. The value of the
activator sample is subtracted from the other samples to determine the platelet
contribution to clot strength.

AA TEG Arachidonic Acid sample. Constitutes one of the PlateletMapping assay


tests and is used to determine how effective aspirin is in blocking platelet
activation. It is also sensitive to other arachidonic acid pathway (COX-1,
thromboxane pathway) inhibitors.

ADP TEG Adenosine Diphosphate sample. Constitutes one of the PlateletMapping


assay tests and is used to determine drug effectiveness when a patient is on
ADP platelet inhibiting drugs (e.g., clopidogrel, prasugrel). It is also sensitive to
GPIIb/IIIa inhibiting drugs (e.g., abciximab, tirofiban, eptifibatide). The ADP
assay can also be used as an initial screening check for genetic inhibition, diet,
or herbals that affect ADP platelet activation.

A/D box A hardware component in the TEG system that converts the analog signal
produced by the analyzer into a digital signal that is read by the TEG Analytical
Software.

aPTT Activated Partial Thromboplastin Time. A test that measures clotting time in
plasma (the liquid portion of blood). It focuses on the intrinsic pathway in the
blood clotting process and uses a contact activator (kaolin, celite, silica, or
elagic acid) to speed up the test time.

activator A substance that causes a reaction or speeds up a process. Also a TEG sample
type (refer to “A” above).

adenosine diphosphate A platelet agonist. Activates the ADP receptors on a platelet.

aggregation The formation of a mass of cells due to binding of specific cell receptors. In
platelets, the receptors associated with aggregation are the GPIIb/IIIa receptors.

agonist A drug or other chemical that can combine with a receptor on a cell to
produce a physiologic reaction typical of a naturally occurring substance.

anticoagulant A substance that slows or prevents the clotting of blood.

antifibrinolytic A drug or endogenous protein that decreases the breakdown of fibrin (e.g.,
amicar, transexamic acid, plasminogen activator inhibitor-1 (PAI-1)).

antiplatelet drug A drug that reduces or inhibits platelet activation.

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Glossary C-3

arachidonic acid A platelet agonist. Its action stimulates a pathway that results in activation of
the thromboxane (TxA2) receptors on a platelet.

aspirin An irreversible platelet inhibitor. It inhibits the action of the COX-1 enzyme in
the arachidonic pathway leading to inhibition of thromboxane synthesis. TEG
action: this drug will not alter the MA of a thrombin-activated TEG analysis.
The AA PlateletMapping assay is required to observe the effects of this drug.
Most significant TEG effect: decreases MAAA.

CLIA Clinical Laboratory Improvements Amendment. Passed in 1988 by the United


States government to establish quality standards for laboratory testing.

CLSI Clinical and Laboratory Standards Institute. A global, nonprofit standards


organization that promotes the development and use of voluntary laboratory
consensus standards and guidelines.

CPB Cardiopulmonary bypass.

cardiopulmonary bypass Diversion of the flow of blood to the heart directly to the aorta, via a pump
oxygenator, avoiding both the heart and the lungs. A form of extracorporeal
circulation used in heart surgery.

cilostazol An antiplatelet drug similar to dipyridamole. Also known as Pletal®.


(Phosphodiesterase 3 inhibitor).

citrate A substance used to anticoagulate blood by chelating calcium. Its action can
be overridden by adding calcium. Used as a preservative in blood samples.

clopidogrel (Plavix®) A potent oral antiplatelet agent often used in the treatment of coronary artery
disease, peripheral vascular disease, and cerebrovascular disease. Also known
as Plavix®. TEG action: this drug will not alter the MA of a thrombin-activated
TEG analysis. The ADP PlateletMapping assay is required to observe the effects
of this drug. Most significant TEG effect: decreases MAADP.

coagulation The formation of a blood clot.

coagulation factor A substance in the blood that is essential for blood clot formation.

coagulopathy A disorder in which blood is either too slow or too quick to coagulate (clot).

Coumadin® A vitamin K antagonist that interferes with the production of vitamin K-


dependent clotting factors (Factors II, VII, IX, and X). Also known as warfarin.
TEG effect: increases R.

cryoprecipitate A concentrated product made from plasma that contains Factors VIII, XIII,
fibrinogen, vWF, and fibronectin. TEG effect: decreases R.

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C-4 Glossary

D-dimer A laboratory test for measuring cross linked fibrin breakdown. The results help
rule out, diagnose, and monitor diseases and conditions that cause
hypercoagulability. High D-dimer results can suggest that there has been
significant clot (thrombus) formation and breakdown in the body, but it does
not tell the location or cause. An elevated D-dimer may be due to a venous
thrombotic event (VTE) or disseminated intravascular coagulation (DIC), but it
may also be due to a recent surgery, trauma, or infection. Elevated levels are
also seen with liver disease, pregnancy, eclampsia, heart disease, and some
cancers.

dipyridamole (Persantine®) An antiplatelet drug. Also known as Persantine®. TEG action: requires ADP
PlateletMapping assay to demonstrate effects. Most significant TEG effect:
decreases MAADP.

dysfunction Abnormal or impaired functioning, especially of a bodily system or organ.

Effient® See prasugrel.

endothelium The single cell layer that lines all blood vessels. The function of the
endothelium includes acting as a barrier between the blood and extravascular
space, hemostasis regulation, and hemodynamic regulation.

eTest An electronic test that is part of the daily maintenance for TEG analyzers
connected via the serial port Analog/Digital interface box.

enzymatic For coagulation, this relates to the coagulation factor reactions and their
related substances.

fibrin An elastic protein derived from fibrinogen by the action of thrombin and forms
an insoluble network that provides a structure for the blood clot.

fibrinogen A protein in the blood plasma that is essential for the coagulation of blood and
is converted to fibrin by thrombin and ionized calcium. Also called Factor I.

fibrinolysis The breakdown of fibrin in a blood clot, usually by the enzymatic action of
plasmin.

fibrinolytic An endogenous protein or drug that breaks down fibrin, either directly or
through the generation of plasmin (i.e. tissue plasminogen activator (tPA),
urokinase).

FDP Fibrin degradation products. Protein fragments produced by the enzymatic


action of plasmin on fibrin and fibrinogen.

FFP Fresh frozen plasma. Plasma that is removed from a donor, separated, and
frozen within 6-8 hours of collection.

glycoprotein (GP) A macromolecule composed of a protein and a carbohydrate (a sugar).

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Glossary C-5

hemorrhage An escape of blood from the blood vessels, especially when excessive. Also
called hemorrhea.

heparin An anticoagulant that binds to antithrombin III to inhibit thrombin activity.


Requires antithrombin III as a cofactor. Unfractionated heparin (UFH) and low
molecular weight heparin (LMWH) are two forms of heparin. Some hemostasis
tests are limited to being able to test one of these forms. TEG testing
demonstrates the effect of both these types. Most significant TEG effect:
increases R.

heparinase An enzyme that breaks down heparin.

hyper Above, beyond, or excessive.

hypo Beneath, under, or deficient.

in vitro In an artificial environment outside the living organism.

in vivo Within a living organism.

ischemia (ischemic) A decrease in the blood supply to an organ or tissue resulting in a reduced
oxygen supply.

kaolin A fine, white clay used to accelerate the clotting process.

lysis The dissolution or destruction of cells, such as blood cells or bacteria, as by the
action of a specific lysin (plural: lyses).

PT Prothrombin time. A test that measures the clotting time of plasma (the liquid
portion of the blood). It focuses on the extrinsic pathway in the blood clotting
process and uses tissue factor as an activator.

PTT Partial Thromboplastin Time. A test that measures clotting time in plasma (the
liquid portion of blood). It focuses on the intrinsic pathway in the blood
clotting process. In the 1970s, activators were added to activate contact factors
to speed up the test time and the test became aPTT (see “aPTT”).

parameter A measurable factor.

Persantine® See dypyridamole.

phospholipid The primary structural components of cell membranes.

plasma The clear, yellowish fluid portion of blood, lymph, or intramuscular fluid in
which cells are suspended.

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C-6 Glossary

plasmin A proteolytic enzyme (i.e. breaks down proteins) that hydrolyzes peptides and
esters of arginine and histidine and converts fibrin to soluble products.

plasminogen The inactive precursor to plasmin that is found in body fluids and blood
plasma.

platelet A minute, irregularly shaped, disk-like cytoplasmic body found in blood


plasma that promotes blood clotting and has no definite nucleus, no DNA, and
no hemoglobin. Also called blood platelet or thrombocyte.

Plavix® See clopidogrel.

prasugrel A platelet inhibitor developed for patients with acute coronary syndromes who
undergo percutaneous coronary intervention. Also known as Effient ®. TEG
action: this drug will not alter the MA of a thrombin-activated TEG analysis.
The ADP-PlateletMapping assay is required to observe the effects of this drug.
Most significant TEG effect: decreases MAADP.

procoagulant An agent that promotes blood coagulation.

protamine sulfate Used to neutralize the effect of heparin.

rFVIIa Recombinant Factor VIIa. A prohemostatic drug that is used to improve


hemostasis. TEG actions: decreases R, may increase MA.

sepsis The inflammatory condition resulting from the presence of pathogens or their
toxins in blood.

serotonin A naturally occurring derivative of tryptophan found in platelets, cells of the


brain, and the intestine. When blood vessels are damaged, activated platelets
release serotonin which acts as a potent vasoconstrictor.

vascular Of, relating to, or containing blood vessels.

TEG® Thrombelastograph®.

Thrombelastograph® A device used to measure the change in elastic properties during clot
formation.

thrombin The central clotting factor in the hemostasis process that facilitates the
conversion of fibrinogen to fibrin, activates other clotting factors, and is the
most potent activator of platelets. Thrombin generation is the pivotal point in
the hemostasis process. This enzyme is formed in the blood from prothrombin.

thrombosis Formation or presence of a blood clot (thrombus).

thrombotic Of or relating to thrombosis.

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Glossary C-7

thrombus A blood clot. The final product of blood coagulation from the hemostasis
process.

tracing For TEG testing, the graph that is produced that plots clot strength versus time.

vascular Of, relating to, or containing blood vessels.

von Willebrand Factor A large multimeric glycoprotein present in blood plasma and produced
(vWF) constitutively in endothelium, megakaryocytes (alpha-granules of platelets),
and subendothelial connective tissue. A protein required for platelet adhesion.

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Appendix D

Initial Setup
INITIAL SETUP OVERVIEW ..................................................... D-2
UNPACKING THE ANALYZER . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .D-3
SETUP AND INSTALLATION. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .D-4
Positioning the analyzer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .D-4
Connecting to the interface box and computer . . . . . . . . . . . . . . . . . . . .D-4
Connecting to power . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .D-5
Disconnecting from power . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .D-5
Connecting multiple analyzers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .D-5
Installing the software . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .D-6
Conducting maintenance checks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .D-6
ACTIVATING THE CHANNELS FOR A NEW ANALYZER . . . . . . . . . . . . . .D-7

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D-2 Initial Setup

INITIAL SETUP OVERVIEW


In most cases, a Haemonetics® representative is responsible for the initial
unpacking and setup of the TEG® analyzer. The instructions in this section are
provided in the event that a repaired analyzer is shipped back to you or that you
need to relocate the analyzer.
This appendix includes the following instructions:
⚫ Unpacking the analyzer
⚫ Setting up and installing single and multiple analyzers
⚫ Activating the channels for a new analyzer

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Initial Setup D-3

UNPACKING THE ANALYZER


The TEG analyzer is packaged to prevent damage to the instrument during
shipping.

Note: Save the shipping box and molded polystyrene support forms. If the TEG
analyzer needs to be returned for repair or preventive maintenance, it must be
shipped in its original packaging in order to avoid damage. Haemonetics will
charge for any repairs necessary due to improper packaging.

To unpack the analyzer from its shipping box:


1. Lift the analyzer, along with the polystyrene support forms, from the
shipping box.
2. Carefully remove the following packaging:
⚫ Support forms from each side of the analyzer
⚫ Support forms for the carriers
⚫ Tape holding each carrier and lever
⚫ Tape holding the back foot

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D-4 Initial Setup

SETUP AND INSTALLATION


Before setting up the analyzer, make sure you have the following components
ready:
⚫ Computer with printer (refer to the TEG 5000 System Site Administrator’s
Guide for system requirements).
⚫ Power supply unit (cord and adapter)
⚫ Uninterruptible Power Supply (UPS) unit
⚫ Analog/Digital (A/D) interface box
⚫ DB-9 cable (male-male)
⚫ DB-9 cable(s) (female-female) - one per analyzer
⚫ TEG Analytical Software installation CDs - Version 4.2.3 Enabled and, if
applicable, Version 4.2.3 Remote.

Positioning the The analyzer should be set up in a location that meets the following
analyzer requirements:
⚫ Minimum of one cubic foot of clearance.
⚫ Sturdy and level surface.
⚫ Free of vibration and away from high traffic.
⚫ Room temperature less than 30 °C.
⚫ Out of the direct path of HVAC ducts or vents.

Note: For more information on operation and storage requirements for the
TEG analyzer, refer to “Storage and Handling” on page 3-2 and
“Specifications” on page B-2.

Connecting to the To connect the TEG analyzer to the analog/digital interface box and computer:
interface box and 1. Insert one end of the female-female DB-9 cable into the 9-pin port labeled
computer “I/O” on the back panel of the analyzer.
2. Insert the other end of the female DB-9 cable into the port labeled “TEG 1”
on the interface box.

Note: There must always be one analyzer connected to the TEG1 port and
powered on.

3. Insert one end of the male-male DB-9 cable into the port on the interface
box labeled “COMPUTER.”
4. Insert the other end of the male DB-9 cable into the 9-pin port on the
computer.

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Initial Setup D-5

5. Tighten the thumb screws on the ends of the plugs to ensure a good
connection.

Connecting to To connect the analyzer to power:


power 1. Insert the male 4-pin connector end of the power cord into the receptacle
labeled “Power” on the back panel of the analyzer.
2. Plug the other end of the power cord into a UPS unit and then into a
grounded wall outlet as per the UPS manufacturer’s instructions.

Warning: Always plug the power cord into the analyzer first, then into the
UPS and then the wall outlet. This prevents the possibility of electrical
shock or power supply damage.

3. Press the green POWER button on the front of the analyzer. The power
button and yellow MOTOR button illuminate when the analyzer is
powered on.
4. Check to ensure the green light on the interface box is illuminated; this
indicates that all the cables are connected properly.

Note: For more information on cautions and electrical requirements for the
TEG analyzer, refer to “Power outlet connection” on page 3-3 and
“Electrical specifications” on page B-3.

Disconnecting To disconnect the analyzer from power:


from power 1. Unplug the UPS unit from the wall outlet.

Warning: Do not remove the power cord from the back of the analyzer
without first unplugging the UPS from the wall outlet. This prevents the
possibility of electrical shock or power supply damage.

2. Unplug the analyzer power cord from the UPS unit and then from the back
panel of the analyzer.

Connecting You can connect up to four analyzers to a computer using one analog/digital
multiple interface box.
analyzers Make sure you have the following components ready when connecting multiple
analyzers:
⚫ One power supply unit per analyzer (included with analyzer purchase).
⚫ One female-female DB-9 cable per analyzer.

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D-6 Initial Setup

To connect additional analyzers to the analog/digital interface box:


1. Insert one end of a female DB-9 cable into the 9-pin port labeled
“I/O” on the back panel of the first additional analyzer.
2. Insert the other end of the female DB-9 cable into the port on the interface
box labeled “TEG 2.”
3. Tighten all connections.
4. Plug the power supply unit into a designated outlet and the cord into the
receptacle labeled “Power” on the back panel of the analyzer.
5. Repeat with each additional analyzer.
6. Press the green POWER button on the front of each analyzer.

Installing the For instructions on installing and uninstalling the software, refer to the TEG 5000
software System Site Administrator’s Guide.

Conducting After setting up an analyzer, maintenance checks must be performed to ensure


maintenance that it is working correctly. For instructions, refer to “Conducting Daily
checks Maintenance Checks” on page 7-5.
If this is a new analyzer, refer to the following section to activate the channels.

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Initial Setup D-7

ACTIVATING THE CHANNELS FOR A NEW ANALYZER


Before working with a new analyzer, the channels must be activated in the TEG
Analytical Software. The following steps are performed in the Maintenance
screen:
⚫ Add the analyzer serial number.
⚫ Associate the serial number with each channel.
⚫ Indicate the analyzer type.
When information is entered for the Analyzer serial number, Channel attached,
and Analyzer type fields, it is automatically copied to its “partner” channel. For
example, when the serial number for channel 1 is entered, it is automatically
copied to channel 2.
To activate the channels in the TEG Analytical Software:
1. Log in to the TEG Analytical Software (TAS). For instructions, refer to
“Logging In To TAS” on page 5-5
2. In the Main screen, on the Options menu, click Maintenance.

Figure D-1, Options menu


3. In the Maintenance screen, click the Setup tab.

Figure D-2, Setup tab, Maintenance screen


4. Complete the following fields:

Note: The fields are completed in an order that is different than the order
they appear on the screen.

TEG® 5000 System User Manual P/N 06-510-US, Manual revision: AD


D-8 Initial Setup

Field Description

Analyzer serial number Type the serial number of the analyzer.


The serial number consists of 11
characters and is located on the label on
the back of the analyzer. It is preceded by
“HS No.” Note: TEG analyzers
manufactured after August 2010 are
assigned 10-character alpha-numeric
serial numbers.

Channel attached Click the checkbox for the channel


number that corresponds to the serial
number entered.

Analyzer type In the drop-down list, select the


appropriate analyzer model.

Channel serial number Select or type the serial number.


(optional field) Note: The channel (or column) serial
number is located on the label on the
back of the analyzer under the analyzer’s
serial number.

5. Click the Daily maintenance tab.

Figure D-3, Daily Maintenance tab, Maintenance screen


6. Select the first channel that was set up and click eTest. Repeat for the
second channel.
Wait for a final message to display (for example, “eTest value is OK” or
“eTest value off center”).

Note: This step is performed in order to save the information that you
entered on the Setup tab. You are not performing an eTest at this step.
For instructions on performing an eTest, refer to “Performing an eTest” on
page 7-7.

7. Click Done.

06-510-US, Manual revision: AD TEG® 5000 System User Manual


Index

Index
INDEX ...........................................................................I-2

TEG® 5000 System User Manual P/N 06-510-US, Manual revision: AD


I-2 Index

INDEX

Symbols assay
Functional Fibrinogen 4-15
§ (sample note) 8-59
PlateletMapping 4-15
¶ (patient note) 8-60
Audit report 8-49
Audit report data screen 8-49
A
A (Activated) sample type 4-13 B
A (Amplitude) parameter 4-7
backing up databases 9-14
A/D interface box
BASE adjustment screw 2-7
connecting
baseline, adjusting eTest values 7-8
multiple analyzers D-5
biological controls. See QC samples
single analyzer D-4
blood collection. See samples, collecting
serial port, description 2-7
Blood Products tab (Edit case screen) 10-13
A30 parameter 4-8
blood products, editing patient case records 10-13
A60 parameter 4-8
blood samples. See sample types; samples
AA (Arachidonic Acid) sample type 4-13
bloodborne pathogens
Access, importing databases into 9-21
accessories, approved use of 11-5 about 3-3
accuracy of TEG analyzer B-6 contaminated materials
disposing of 3-4
ACT (Activated Clotting Time). See RapidTEG
proper handling 3-3
activator
kaolin 4-14
RapidTEG 4-14
active filter 8-21 C
Add Sample type screen 6-12 cables
Add test screen 6-4 carrier ribbon
Add to Guide screen 8-34 checking 7-6
ADP (Adenosine Diphosphate) sample type 4-13 description 2-4
advanced filters power
about 8-21 connecting D-5
case 8-27 description 2-7
channel 8-25 disconnecting D-5
custom 8-28 specification B-3
dates 8-26 warnings 3-3
patient 8-24 requirements for setup D-4
sample type 8-24 serial
test results 8-22 DB-9 female-female D-4, D-5
Amplitude (A) 4-7 DB-9 male-male D-4
Amplitude, 30 mins (A30) 4-8 CAL adjustment screw 2-7
Amplitude, 60 mins (A60) 4-8 calibration
Analog/Digital interface box. See A/D interface box about adjusting 2-7
Analysis report (single-sample, multi-sample) 8-37 preventive maintenance 11-4
Angle calculation, warning 6-18 Capture function, about 12-8
Angle parameter 4-4 Capture options screen 12-8
APR (Aprotinin) sample type 4-13 carrier ribbon cables, checking 7-6
archiving lot numbers 11-13

P/N 06-510-US, Manual revision: AD TEG® 5000 System User Manual


Index I-3

carriers Coagulation Index (CI)


cleaning 7-28 description 4-5
description 2-3 equation 4-5
ribbon cables coagulopathy library (Guide)
about 2-4 about 8-33
checking 7-6 adding tracing 8-33
shafts 2-5 deleting library entry 8-36
Case icon 10-5, 10-10 modifying library entry 8-35
case records. See patient case records collection tubes 7-18
Case summary report. See Patient Hemostasis Color screen 6-21
Summary report colors
Case tab (Filter criteria screen) 8-27 5 minute marks 6-21
CFF (Citrated Func. Fibrinogen) sample type 4-12 channels on TEG screen 5-18
CFFH (Citrated Func. Fibrinogen w/Heparinase) grid lines 6-21
sample type 4-12 tests 6-21
channel error codes 5-11 tracings 6-22
Channel tab (Filter criteria screen) 8-25 columns, description 2-4
CI (Coagulation Index) parameter 4-5 COM ports
citrated blood samples avoiding communication interference B-5
about, sample type 4-14 setting 6-19
collecting 7-19 communication interference for analyzer B-5
CK (Citrated Kaolin) sample type 4-12 compacting databases 9-16
CKH (Citrated Kaolin w/Heparinase) sample type component illustrations
4-12 exterior back 2-6
CL30 parameter 4-8 exterior front 2-3
CL60 parameter 4-8 configuring user profiles
cleaning about 6-2
precautions for blood 3-3 eConsult 6-25
procedure for analyzer 7-28 login 6-24
clinical training 1-4 reference ranges 6-8
Clinicians tab (Edit case screen) 10-15 sample types 6-11
clinicians, editing patient case records 10-15 software 6-15
clot tests 6-3
avoiding activation of 11-3 video 6-20
formation parameters consumables, approved use of 11-5
primary 4-4 contaminated materials
secondary 4-6 proper disposal of 3-4
forming in cup 4-2, 4-3 proper handling for 3-3
graphic, showing on data panel 6-16 Corrective action screen 7-13
kinetic, strength, and stability parameters 4-9 corrupted databases, repairing 9-16
kinetics, K parameter 4-4 covers
lysis parameters front 2-5
primary 4-4 hazard if removing 3-3
secondary 4-8 rear 2-7
shear elasticity units 4-3 Create case screen 10-3, 10-5
velocity parameters 4-10 CRT (Citrated RapidTEG). See RapidTEG
Clot Lysis Time (CLT) 4-9 CRTH (Citrated RapidTEG w/Heparinase). See
CLT parameter 4-9 RapidTEG
Cluster tracings pop-up window 10-16 cups and pins
Clusters tab (Edit case screen) 10-16 design 4-2
CN (Citrated Native) sample type 4-13 ejecting 7-16

TEG® 5000 System User Manual P/N 06-510-US, Manual revision: AD


I-4 Index

formation of clot in 4-2 Dates tab (Filter criteria screen) 8-26


heparinase 4-15 DB-9 cables (male & female) D-4, D-5
loading 7-14 decontamination precautions 3-3
rotation mechanics 4-2 Delete Patient screen 10-8
troubleshooting A-11 Detail icon 8-50, 8-58
cupwells, description 2-3 Detail screen 8-51
Custom tab (Filter criteria screen) 8-28 about 8-50
customer service accessing
clinical training 1-4 using Detail icon 8-50
contacting 1-4 using status bar 8-51
repair service 1-4 Notes tab 8-58, 8-59
Sample tab 8-56
Tracing tab 8-53
D discard tube, using for blood collection 7-19
daily maintenance checks 7-5 disinfecting
Daily Maintenance Log report 8-47 precautions for 3-3
Daily Maintenance tab (Maintenance screen) 7-7 procedure for analyzer 7-28
daily operation tasks display options
about 7-2, 7-5 changing sample types order 6-13
checking carrier ribbon cables 7-6 changing tests order 6-6
leveling analyzer 7-6 colors and lines 6-20
loading cups and pins 7-14 data pop-up panel 6-16
performing eTest 7-7 displaying clot graphic 6-16
running QC samples 7-9 flashing values 6-16
Data icon 8-6 grid lines 6-16
Data pop-up panel, customizing 6-16 including sample types 6-13
data tracings. See tracings including tests 6-6
Database Patient List report (patient report) 8-41 time 6-17
databases disposal
about 9-2, 11-8 handling contaminated material 3-4
backing up 9-14 drawings. See illustrations
changing to QC database 9-4 drugs used, editing patient case records 10-13
compacting 9-16
creating new 9-6
deleting 9-13 E
exporting E (Elasticity constant) parameter 4-7
about 9-9 eConsult
using tab-delimited format 9-9 about 12-3
using TEG database format 9-9 defining recipient 6-27
importing defining server settings 6-27
into Access 9-21 prerequisites for using 12-3
into another database 9-7 removing recipient 6-28
into Excel 9-19 sending patient data 12-3
merging 9-17 setting up e-mail account 6-26
opening 9-3 eConsult tab (User profile setup screen) 6-25
repairing corruption 9-16 eConsult wizard screen 12-5
setting defaults 6-24 ECT (Ecarin Clotting Time) sample type 4-13, 6-18
switching between patient and QC 9-5 Edit case - Notes screen 8-61
troubleshooting A-7 Edit case screen 8-42, 8-61, 10-10
date of birth, editing patient case records 10-14 Eject position, lever 2-4

P/N 06-510-US, Manual revision: AD TEG® 5000 System User Manual


Index I-5

Elasticity constant (E) 4-7 channel 8-25


electrical shock hazards 3-3, D-5 custom 8-28
electrical specifications for analyzer B-3 dates 8-26
e-mail patient 8-24
defining eConsult recipient 6-27 sample type 8-24
defining server settings 6-27 test results 8-22
removing eConsult recipient 6-28 quick
sending records using eConsult 12-3 about 8-20
setting up account 6-26 active 8-21
E-mail server settings screen 6-27 patient 8-20
Enabled version of TAS, about site 8-20
ending sample run 7-27 using combination of 8-19
Enter Lot number information screen 11-10, 11-12 5 minute marks, setting color for 6-21
Enter sample information screen 10-6 flashing parameter values
environmental specifications for analyzer B-2 about 8-3
EPL parameter 4-9 customizing 6-16
errors FLEV
error codes on TAS Main screen 5-11 parameter 4-10
QC samples 7-12 units, setting 6-16
troubleshooting A-2 viewing value in FF samples 8-16
Establishing reference ranges for QC Functional Fibrinogen
new Mean 11-17 about 4-12, 8-16
preliminary Mean 11-18 assess platelet contribution to clot strength 8-17
Estimated Percent Lysis (EPL) 4-9 FLEV parameter 4-10
eTest preparing samples 7-25
about 7-7 sample type (FF) 4-15
adjusting values 7-8 viewing tracings 8-16
BASE adjustment screw
adjusting 7-8
description 2-7 G
procedure 7-7 G (clot strength) parameter 4-7
sensitivity factors B-4 glossary terms C-2
troubleshooting A-9 GoTo menu 9-5
Excel, importing databases into 9-19 grid lines
Export data wizard screen 9-9, 9-11 setting color 6-21
exporting a database 9-9 setting style of 6-22
showing 6-16
Guide
F about 8-30
FF (Func. Fibrinogen) sample type 4-12 coagulopathy library
FFH (Func. Fibrinogen w/Heparinase) sample type about 8-33
4-12 adding tracing to library 8-33
fibrinolysis 4-3 deleting library entry 8-36
File menu, about 5-19 modifying library entry 8-35
Filter criteria screen 8-22 manually selecting tracing 8-32
filters Show Me feature 8-30
about using 8-19 Guide - Bleeding status screen 8-30
advanced Guide - Pattern matching screen 8-32
about 8-21 Guide - Pattern selection screen 8-31
case 8-27

TEG® 5000 System User Manual P/N 06-510-US, Manual revision: AD


I-6 Index

H L
hardware requirements, setting up analyzer D-4 L parameter 4-11
hazards, electrical shock 3-3, D-5 laboratory techniques
Help menu, about 5-20 avoiding clot activation in samples 11-3
hemostasis profile 4-3 precautions for blood samples 11-3
heparin Level I and Level II controls. See QC samples
about B-5 leveling
avoiding contamination B-5 bubble 2-7
blood sample, collecting 7-20 feet 2-5
neutralizer (heparinase) 4-15 instructions for analyzer 7-6
tubes (Vacutainer®) 7-20 levers
heparinase about 2-4
description 4-15 positions (Load, Test, Eject) 2-4
preparing blood samples 7-21 using
ejecting pins 7-16
performing eTest 7-7
I running samples 7-11, 7-27
icons on toolbar 5-13 Levey Jennings report 8-45, 11-5
illustrations LG parameter 4-10
exterior back 2-6 library, coagulopathy 8-33
exterior front 2-3 limitations for analyzer B-4
Import Text Wizard screen 9-22 lines
importing colored dashed on tracing 8-4
databases into Access 9-21 grid on tracing 8-4
databases into another database 9-7 setting style of 6-22
databases into Excel 9-19 solid on tracing 8-4
Include screen 6-6, 6-14 viewing tracing 8-3
infection control strategies 3-3 Load position, lever 2-4
installing locking patient case records 10-15
analyzer. See setup Locking tab (Edit case screen) 10-15
TEG Analytical Software (TAS) D-6 logging in to TAS
interface box. See A/D interface box how to 5-5
interference factors for analyzer B-4 setting defaults for 6-24
interrelationship of parameters 4-11 system timeout 5-7
Introduction screen 12-4 troubleshooting A-3
Login tab (User profile setup screen) 6-24
Lot Number History report 8-47
lot numbers
K about 11-9
K (clot kinetics) parameter archiving 11-13
about 4-4 creating new 11-9
setting units for 6-17 deleting 11-12
kaolin generating history report 8-47
about 4-12, 4-14 reference ranges for 11-9
preparing samples 7-22 restore old 11-13
sample type (K) 4-12 updating 11-12, 11-15
KH (Kaolin w/Heparinase) sample type 4-12 LTE parameter 4-9
kinetic, strength, and stability parameters 4-9 LY30 parameter 4-5
LY60 parameter 4-8
Lysis Time Estimate (LTE) 4-9

P/N 06-510-US, Manual revision: AD TEG® 5000 System User Manual


Index I-7

M N
MA (Maximum Amplitude) parameter N (Native) sample type 4-13, 4-14
about 4-5 native blood samples
calculation warning 6-18 about 4-13, 4-14
limitations B-4 preparing 7-21
Maintenance check message 7-5 reference ranges for 11-16
maintenance checks, conducting daily 7-5 needles used to collect samples 7-18
Maintenance filter screen 8-47 No tracing available message 8-13
Maintenance screen 8-47 non-citrated blood samples, collecting 7-18
manually terminate sample run 7-27 normal tracings
Maximized screen displaying 8-12
about 8-4 setting 8-12, 8-55
displaying setting line style 6-23
data for tracing 8-6 Normal Values tab (User profile setup screen) 6-8
multiple tracings 8-7 normal values. See reference ranges
navigating between tracings 8-8 notes
Maximum Amplitude (MA) 4-5 adding or viewing Notes (patient notes) 8-60
menu options, about 5-19 adding or viewing SNotes (sample notes) 8-59
Merge screen 9-18 editing for patient case records 10-14
merging databases 9-17 Notes (sample) screen 8-60
messages Notes icon 8-61
Channel not at equilibrium 7-8, A-9 Notes tab
COM port is in use or does not exist A-6 Detail screen 8-58, 8-59
Compacting could not be completed A-8 Edit case screen 10-14
Database has too many users printing A-23 NWB (Native Whole Blood) sample type 4-13
Delete Lot number 11-12
Disk or network A-7
Does not exist A-4 O
eTest out of range A-9 off-set mode 8-7
eTest value off center 7-8, A-9 operator report, Analyzer Audit 8-49
File is read only A-3 Options menu, about 5-20
Lot number not found A-20 Other tab (Edit case screen) 10-14
No tracing available 8-13
Object or With Block variable not set A-7
QC Alert 7-12
Search key not found A-7
P
Table cannot be locked A-25 parameters
This may not be the best match 8-33 about 4-4, 5-8
Unrecognized database format A-7 flashing 8-3
motor indicator button 2-5 interrelationship of 4-11
MRL parameter 4-11 MA calculation, warning 6-18
MRLG parameter 4-10 primary clot formation and lysis
MRTG parameter 4-11 Angle 4-4
multiple analyzers, setting up D-5 CI (Coagulation Index) 4-5
multi-sample patient report 8-37 K (clot kinetics) 4-4
LY30 (Percent Lysis, 30 mins) 4-5
MA (Maximum Amplitude) 4-5
R 4-4
TEG-ACT 4-6

TEG® 5000 System User Manual P/N 06-510-US, Manual revision: AD


I-8 Index

secondary clot formation editing


A (Amplitude) 4-7 about 10-10
E (Elasticity constant) 4-7 blood products used 10-13
G (clot strength) 4-7 clinicians 10-15
PMA (Projected MA) 4-6 drugs used 10-13
SP (Split Point) 4-7 locking 10-15
TMA (Time to MA) 4-7 notes 10-14
TPI (Thrombodynamic Potential Index) 4-7 patient identification 10-14
secondary clot kinetic strength, stability procedures 10-12
FLEV (Functional Fibrinogen Level) 4-10 sample information 10-17
secondary clot kinetic, strength, stability viewing PlateletMapping clusters 10-16
% Aggregation 4-9 patient data, sending using eConsult 12-3
% Inhibition 4-9 patient databases
secondary clot lysis backing up 9-14
A30 (Amplitude, 30 mins) 4-8 compacting 9-16
A60 (Amplitude, 60 mins) 4-8 creating new 9-6
CL30 (Whole Blood Clot Lysis Index, 30 deleting 9-13
mins) 4-8 exporting 9-9
CL60 (Whole Blood Clot Lysis Index, 60 importing
mins) 4-8 into Access 9-21
CLT (Clot Lysis Time) 4-9 into another database 9-7
EPL (Estimated Percent Lysis) 4-9 into Excel 9-19
LTE (Lysis Time Estimate) 4-9 merging 9-17
LY60 (Percent Lysis, 60 mins) 4-8 opening 9-3
setting line styles for tracings 6-23 repairing corruption 9-16
setting options for switching to QC 9-5
FLEV 6-16 troubleshooting A-7
SP, R, and K units 6-17 patient filter 8-20
VCurve 6-19 Patient Hemostasis Summary (case summary) report
velocity 8-41
L 4-11 Patient report screen 8-41
LG 4-10 Patient report sort screen 8-41
MRL 4-11 patient reports
MRLG 4-10 Analysis (single-sample, multi-sample) 8-37
MRTG 4-11 Database Patient List (patient report) 8-41
MRTGG 4-10 Patient Hemostasis Summary (case summary)
TG 4-11 8-41
TGG 4-10 patient samples. See sample types; samples
TMRL 4-11 Patient tab (Filter criteria screen) 8-24
TMRLG 4-10 Percent Aggregation parameter 4-9
TMRTG 4-11 Percent Inhibition parameter 4-9
TMRTGG 4-10 Percent Lysis
patient case records 30 minutes (LY30) 4-5
about 10-2 60 minutes (LY60) 4-8
adding performance characteristics
notes to 8-60 about B-6
sample record to 10-6 accuracy B-6
using Case icon 10-5 precision B-7
using Records menu 10-3 sensitivity and specificity B-4, B-8
deleting 10-8 physical specifications for analyzer B-2
PL (Plasma) sample type 4-13

P/N 06-510-US, Manual revision: AD TEG® 5000 System User Manual


Index I-11

platelet contribution 8-17 profiles, configuring user 6-2


PlateletMapping Projected MA (PMA) 4-6
about 4-15, 8-14
displaying % inhibition popup 6-17
generating results 8-14 Q
% Aggregation parameter 4-9 QC Alert message 7-12
% Inhibition parameter 4-9 QC databases
preparing samples 7-24 about 11-8
sample types (A, ADP, AA) 4-15 backing up 9-14
viewing reports changing or creating new 9-4
Patient Hemostasis Summary (case compacting 9-16
summary) 8-41 creating new 9-6
TEG Analysis (multi-sample) 8-38 deleting 9-13
viewing sample clusters 10-16 exporting 9-9
viewing tracings 8-13 importing
platform on analyzer, about 2-5 into Access 9-21
PM pop-up window 8-15 into another database 9-7
PMA (Projected MA) parameter 4-6 into Excel 9-19
POP3 server, specifying 6-27 merging 9-17
potentiometer screws opening 9-3
adjusting for eTest 7-8 repairing corruption 9-16
BASE, about 2-7 setting defaults for 6-24
CAL, about 2-7 switching to patient 9-5
power troubleshooting A-7
about supply connection 2-7 QC Lot Number screen 11-12
cables, about 2-7 QC menu, about 5-19
connecting analyzer to D-5 QC report screen 8-46
disconnecting analyzer from D-5 QC samples
indicator button 2-4 about 7-9, 11-6
warnings for outlet connection 3-3 alerts 11-8
precautions establishing reference ranges for
blood samples 11-3 about 11-8
disposing of contaminated materials 3-4 obtaining Mean and SD using TAS 11-17
electrical shock hazards 3-3, D-5 investigating errors 7-12
handling blood 3-3 managing lot numbers 11-9
laboratory techniques 11-3 running Level I 7-10
storing running Level II 7-12
analyzer 3-2 setting transfer options for 6-17
disposables 3-2 storage precautions for 3-2
reagents and controls 3-2 troubleshooting A-12
transporting analyzer 3-2 updating reference ranges for 11-15
precision of TEG analyzer B-7 verifying the results for 7-13
Print icon 8-10 QC select Lot number screen 11-9
printing QC Summary (Levey Jennings) report 8-45
reports 8-37 quality assurance
tracings using Capture 12-8 about 11-2
tracings using Quick Print 8-10 about quality control methods 11-4
troubleshooting A-23 functional checks for analyzer 11-4
Procedure tab (Edit case screen) 10-12 managing lot numbers 11-9
procedures, editing patient case records 10-12 operational checks for analyzer 11-4
product return guidelines 1-4

TEG® 5000 System User Manual P/N 06-510-US, Manual revision: AD


I-10 Index

QC samples for new lots 11-9


about 11-6 Normal values tab 6-8
establishing reference ranges for 11-8 setting line styles 6-22
obtaining Mean and SD using TAS 11-17 troubleshooting A-21
reference ranges 11-8, 11-15, 11-17 updating 11-15
reports viewing for samples 6-9
about 11-5 reference tracings
Daily Maintenance Log 8-47 displaying 8-11
Lot Number History 8-47 setting 8-10, 8-55
QC Summary (Levey Jennings) 8-45 setting the line style for 6-23
schedule, quality control 11-5 Remote version of TAS
using approved accessories & consumables 11-5 about 5-2
quality control reports. See quality assurance, reports troubleshooting access for A-22
quality control samples. See QC samples Rename screen 6-5
quick filters repair service 1-4
about 8-20 Report options screen 8-38, 8-43, 11-17
active 8-21 reports
patient 8-20 about 8-37
site 8-20 operator
Quick Print Analyzer Audit 8-49
printing a tracing 8-10 patient
setting options for 6-17 Analysis (single-sample, multi-sample) 8-37
Database Patient List (patient report) 8-41
Patient Hemostasis Summary (case
R summary) 8-41
R (or R-time) parameter quality assurance
about 4-4 Daily Maintenance Log 8-47
setting units for 6-17 Lot Number History 8-47
RapidTEG QC Summary (Levey Jennings) 8-45
about 4-12, 4-14, 8-17 resetting color and line styles 6-23
including sample types in software 8-18 Restore Lot number screen 11-13
preparing samples 7-23 return analyzer for repairs 1-4
sample types 4-12 ribbon cables. See cables, carrier ribbon
setting termination options 6-18 RT (RapidTEG). See RapidTEG
TEG-ACT parameter 4-6, 8-18 RTH (RapidTEG w/Heparinase). See RapidTEG
viewing tracings 8-17, 8-18 run termination settings 6-18
Reaction time (R). See R (or R-time) parameter running samples. See samples, running blood
reagents, storage precautions for 3-2 samples
recalcification 4-14 Rx tab (Edit case screen) 10-13
Records menu, about 5-19
records. See patient case records
Reference icon 8-10 S
reference ranges S1 (Special ST1) sample type 4-13
about 11-15, B-8 S2 (Special ST2) sample type 4-13
assigning values to tests 6-9 safe operation of analyzer 3-2
changing values for a test 6-10 Sample info pop-up panel 6-16, 8-6
establishing QC ranges Sample tab (Detail screen) 8-56
about 11-8 Sample type tab (Filter criteria screen) 8-24
obtaining Mean and SD using TAS 11-17
for native samples 11-16

P/N 06-510-US, Manual revision: AD TEG® 5000 System User Manual


Index I-11

sample types setting


about 4-12 normal tracings 8-55
adding new 6-12 reference tracings 8-55
adding test values for 6-9 termination options 6-18
including in display 6-13 supplies for collecting 7-18
L1 and L2 (quality control) troubleshooting A-19
legacy 4-13 updating reference ranges 11-15
modified whole blood 4-14 using constant time intervals B-5
moving order on screen 6-13 viewing
native whole blood 4-14 details 8-50
quality control (QC) 11-6 tracings 8-3
sodium-citrated whole blood 4-14 Samples tab (Edit case screen) 10-17
viewing reference ranges for 6-9 schedule, quality control 11-5
Sample Types tab (User profile setup screen) 6-11 Select case mode screen 8-41, 10-5, 10-10
samples Select samples screen 8-42, 9-10, 12-4
See also QC samples SEMS (Shear elastic modulus strength) 4-7
about collecting and preparing 7-17 sensitivity factors for analyzer B-4
adding SNotes (sample notes) 8-59 serial cables, DB-9 D-4, D-5
avoiding clot activation 11-3 serial port, A/D interface box 2-7
collecting servicing the analyzer 1-4
about 7-18 set points, adjusting 7-3
citrated 7-19 setup
discard tube 7-18, 7-19 about D-2
heparin 7-20 connecting
non-citrated 7-18 A/D interface box and computer D-4
comparing multiple 8-7 multiple analyzers D-5
deleting a record 10-9 single analyzer D-4
editing for patient case records 10-17 to power D-5
entering details for disconnecting from power D-5
about 8-50 positioning analyzer D-4
on Notes tab 8-58, 8-59 requirements for D-4
on Sample tab 8-56 unpacking analyzer D-3
on Tracing tab 8-53 shear elasticity units 4-3
manually create record 10-6 Show me feature, Guide 8-30
precautions for 11-3 single-sample patient report 8-37
preparing site filter 8-20
about 7-20 site ID, setting defaults for 6-24
Functional Fibrinogen 7-25 SMTP server, specifying 6-27
heparinase 7-21 SNotes
kaolin 7-22 adding or viewing 8-59
native (no reagent) 7-21 icon 8-58, 8-59
PlateletMapping 7-24 sodium citrate
RapidTEG 7-23 See also citrated blood samples
running about 4-14
blood samples 7-26 Software tab (User profile setup screen) 6-15
ending sample run 7-27 software. See TEG Analytical Software (TAS)
QC samples 7-10 SP (Split Point) parameter
starting sample run 7-26 about 4-7
selecting on TAS Main screen 5-11 setting units for 6-17
SP, R, and K units, setting 6-17

TEG® 5000 System User Manual P/N 06-510-US, Manual revision: AD


I-12 Index

specifications FLEV units 6-16


electrical B-3 grid lines 6-16
environmental B-2, B-4 login defaults 6-24
physical B-2, B-4, D-4 MA calculation, warning 6-18
Split Point (SP). See SP (Split Point) parameter % inhibition popup 6-17
SSN, editing patient case record 10-14 QC samples transfer options 6-17
status bar 5-12, 8-51 Quick Print 6-17
storage precautions run termination 6-18
analyzer 3-2 SP, R, and K units 6-17
disposables 3-2 time display 6-17
reagents 3-2 touch screen 6-17
superimposed mode 8-7 Vcurve 6-19
support, contacting 1-4 entering sample details 8-50
symbols features overview 5-3
in the manual 1-5 filtering sample records 8-19
in the software 8-59, 8-60 generating and printing reports 8-37
on the analyzer 1-5 installing D-6
System Setup screen 11-11 logging in 5-5
main screens
Detail 8-50
T Maximized 8-4
tab-delimited format, database export 9-9 TAS Main 5-8
TAS Detail screen. See Details screen TEG 5-16
TAS Main screen managing databases 9-2
about 5-8 menu options 5-19
error codes 5-11 sending patient files with eConsult 12-3
selecting a sample 5-11 timing out 5-7
sorting sample order 5-10 troubleshooting A-2
status bar 5-12 viewing
symbols 5-10 sample details 8-50
toolbar icons 5-13 tracings 8-3
TAS Maximized screen. See Maximized screen TEG analyzer
TAS TEG screen. See TEG screen See also daily operation tasks
TAS. See TEG Analytical Software (TAS) about 1-2
technical support adjusting temperature set points 7-3
contacting 1-4 cleaning 7-28
product return guidelines 1-4 collecting and preparing samples 7-17
repair service 1-4 daily maintenance 7-5
TEG Analysis report (single-sample, multi-sample) glossary C-2
8-37 how it works 4-2
TEG Analytical Software (TAS) illustrations 2-2
about Remote and Enabled versions 5-2 interference factors B-4
configuring user profiles 6-2 limitations B-4
customizing loading cups and pins 7-14
about 6-15 models supported 1-2
Angle calculation, warning 6-18 operating overview 7-2
colors and lines 6-20 performance characteristics (accuracy,
data pop-up panel 6-16 precision, sensitivity) B-6
eConsult settings 6-25 precautions for operating 3-2
flashing values 6-16 quality assurance and control 11-4
running samples 7-26

P/N 06-510-US, Manual revision: AD TEG® 5000 System User Manual


Index I-13

sensitivity factors B-4 TG parameter 4-11


setting up D-2 TGG parameter 4-10
specifications B-2 Thrombodynamic Potential Index (TPI) 4-7
storage and handling 3-2 time display 6-17
troubleshooting A-2 Time to MA (TMA) 4-7
using approved accessories & consumables 11-5 timing out 5-7
TEG Analyzer Audit report 8-49 TMA (Time to MA) parameter 4-7
TEG Analyzer Daily Maintenance Log 8-47 TMRL parameter 4-11
TEG Analyzer QC Summary (Levey Jennings) report TMRLG parameter 4-10
8-45 TMRTG parameter 4-11
TEG Analyzer QC Summary report 7-13 TMRTGG parameter 4-10
TEG Analyzer Service History Log 8-48 toolbar icons 5-13
TEG Database Patient List report (patient report) 8-41 torsion wire, illustration 4-2
TEG Lot Number History report 7-13, 8-47 touch screen, enabling 6-17
TEG Patient Hemostasis Summary (case summary) TPI (Thrombodynamic Potential Index) parameter
report 8-41 4-7
TEG sample types. See sample types Tracing tab (Details screen) 8-53
TEG screen tracings
about 5-16 about 5-11, 8-3
accessing 5-16 copying and pasting using Capture 12-8
channel colors 5-18 displaying
completing fields 5-17 data on Sample info pop-up panel 8-6
starting samples 7-26 multiple tracings 8-7
terminating samples 7-27 entering details for
TEG-ACT parameter about 8-50
description 4-6 on Notes tab 8-58, 8-59
viewing 8-18 on Sample tab 8-56
temperature cables. See cables, carrier ribbon on Tracing tab 8-53
temperature controller lines (solid, dashed, grid) 8-3
adjusting set points 7-3 navigating between multiple 8-8
description 2-4 printing
troubleshooting A-20 reports 8-37
terminating samples 7-27 using Quick Print 8-10
termination settings for sample run 6-18 setting
terminology. See glossary terms color 6-22
Test position, lever 2-4 line styles 6-22
Test results tab (Filter criteria screen) 8-22 normal tracings 8-12, 8-55
tests reference tracings 8-10, 8-55
adding troubleshooting unexpected results A-16
new test 6-4 using Guide 8-30
normal ranges for 6-9 viewing
to sample type 6-9 details for 8-50
changing reference values 6-10 Functional Fibrinogen tracings 8-16
including in display 6-6 in offset mode 8-7
moving order on screen 6-6 in superimposed mode 8-8
renaming 6-5 in thumbnail format 8-4
setting colors for 6-21 maximized 8-4
viewing reference ranges for sample type 6-9 parameters 8-3
Tests tab (User profile setup screen) 6-3 PlateletMapping tracings 8-13
Text Import Wizard screen 9-19 RapidTEG tracings 8-17
TF (Tissue Factor) sample type 4-13

TEG® 5000 System User Manual P/N 06-510-US, Manual revision: AD


I-14 Index

training 1-4 W
training, using Guide 8-30 Whole Blood Clot Lysis Index
transporting precautions 3-2 30 mins (CL30) 4-8
trimmer adjustment tool 7-9
60 mins (CL60) 4-8
troubleshooting
whole blood samples
about A-2
modified 4-14
blood sample errors A-19
no modifiers 4-14
compacting errors A-8
sodium-citrated 4-14
cup and pin errors A-11
workstation access, troubleshooting A-22
database errors A-7
eTest errors A-9
login errors A-3
printing errors A-23
Z
QC sample errors A-12 zoom level for VCurve 6-19
reference ranges errors A-21
remote workstation access errors A-22
temperature errors A-20
unexpected tracing results A-16

U
Uninterruptible Power Supply (UPS) D-4
unpacking the analyzer D-3
User profile setup screen 6-2
user profiles
about 6-2
accessing User profile setup screen 6-2
eConsult 6-25
login 6-24
reference ranges 6-8
sample types 6-11
software 6-15
tests 6-3
video 6-20

V
Vacutainer® tubes 7-20
VCurve
converting to G values 6-19
parameters 4-10
setting options for 6-19
velocity parameters
See also VCurve
about 4-10
verifying QC sample results 7-13
Video tab (User profile setup screen) 6-20

P/N 06-510-US, Manual revision: AD TEG® 5000 System User Manual

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