Haemosope Corporation Teg 5000 Service Manual
Haemosope Corporation Teg 5000 Service Manual
Haemoscope Corporation
www.haemoscope.com
Technical Support:
Contact your local service representative, or the main office at:
Haemoscope Corporation
6231 West Howard Street
Niles, IL 60714 USA
800-GET-A-TEG / 800-438-2834
847-588-0453
Fax: 847-588-0455
Web: www.haemoscope.com
E-mail: [email protected]
A
Exploded Assembly . . . . . . . . . . . . . . . . . . . . 29
n Return Shipping Instructions
Obtain RMA and provide PO . . . . . . . . . . . . . . . . . . . 31
Package properly . . . . . . . . . . . . . . . . . . . . . . . . . 31
The TEG® analyzer has been shown to be a reproducible and reliable clinical Quality Assurance
tool when a good quality assurance program that includes proper phlebotomy Overview
techniques and sample handling is followed.
The use of a standardized method for the collection and handling of speci- Laboratory
mens is of utmost importance to ensure that TEG® results are reproducible Techniques and
and reliable. Haemoscope Corporation recommends that the user follow lo- Precautions
cally established procedures for the collection and handling of specimens. Ev-
eryone using the TEG® analyzer should be familiar with standard laboratory
procedures, techniques, and precautions, particularly those that affect hema-
tological testing, as well as with the operation and precautions for the TEG®
analyzer, and how samples are applied and removed. Users should also abide
by Federal, State, and local guidelines for assuring quality control in clinical
laboratories.
Ë Adhering to the time intervals established for native whole blood analysis.
Blood samples should be placed on the TEG® analyzer at 4 minutes after
withdrawal if they have not been sodium citrated or heparinized for lon-
ger storage.
Ë Avoiding touching of the working surfaces of the disposable cups and pins
before sample applications.
Finally, an effective quality assurance program requires that you keep and reg-
ularly review records. The TEG® software is set up to maintain these records
and even to transfer QC data to statistical computer packages for analysis.
General Quality Quality control for the TEG® analyzer consists of the following areas:
Control
Ë Maintenance and function checks
Ë Control procedures
Maintenance and function Mechanical, electronic, and operational checks verify the proper test perfor-
checks mance and test results reporting for the TEG® analyzer.
General General information on the Maintenance submenu is given below. If you need
information on other settings or functions of the software, please consult the
User Guide.
If the service mode box is checked, then no information from this tab will be
stored in the database. Any final messages received before the check box is
selected, or after it is unselected, will not be stored.
Ë Any attached channel can have eTest or Calibration done. Only those
channels that are attached to a 3000 (see setup menu) can do an Event
Marker test.
Ë Any data in a channel when it has a final message (for example, "eTest out
of range" or "Calibration is OK" will be stored in the configuration data-
base, unless the Service mode check box is selected.
Before working with the Daily Maintenance Menu, you must use Setup to set Setup Menu
up information on the attached channels. Click the Setup tab to display the
Setup Menu:
In this menu, the first thing that you must enter (if it is blank) is the machine serial num-
ber. Any machine without a serial number cannot be used.
Ë Once the machine serial number is entered, you must indicate the channels attached
in order to be able to run samples or maintenance on those channels.
Ë Machine type is optional at this point. If it is not entered, then the user will be
prompted when trying to do maintenance.
Ë For machine type, machine serial number and channels attached, any entry is
mirrored on its "partner" channel. So if channel 1 is clicked, then channel 2 also gets
clicked. If you enter a serial number into channel 4, then it is automatically entered
into channel 5.
Service Tab Click on the Service tab to display the Service Submenu.
Nothing on this tab is mandated by the software. It may be required by regulatory rules,
or it can be used to record work done during an in-service, but the software does not re-
quire it. If this data is entered, and then the Maintenance tab is re-entered on
the same day, the same record should be used, with any new data overwriting
existing data.
Ë Due to a software issue, on the report the gap will be rounded to the near-
est tenth.
Undo will undo the last data change you made. It will not work once you About Undo
leave a screen (i.e. if you delete a sample, then go to the main screen, you
cannot undo the deletion).
It will only undo the last change made and cannot undo starting or stopping
samples. It also cannot undo maintenance functions (i.e., it cannot undo an
eTest).
Alignment of the TEG® columns and calibration of the analyzer verify and/or Mechanical
maintain the mechanical functioning of the analyzer. These mechanical func-
tion tests and adjustments are performed at least semi-annually by trained
TEG® users or Haemoscope technicians.
Electronics Testing
Frequency:
(eTest)
Ë Daily.
Whenever the biological controls do not produce results within the speci-
fied ranges, the first troubleshooting test is to check the eTest.
Materials needed:
Procedure:
Select a channel and machine type, enter the serial number(s) of ana-
2. Make sure the analyzer is level and move the lever to the test position.
Message Cause/Remedy
eTest out of range Adjust it with the trimmer adjustment tool using the adjusting
screws on the back of the analyzer labeled BASE that corre-
spond to the column you are working on. See figure 1. The ana-
lyzer is labeled with arrows indicating which way to turn the
screw to increase the reading. Turn in the opposite direction to
decrease it.
When the reading is within the normal range of 1800-2300, the computer is-
sues the message:
eTest is OK
If the eTest is OK, check the next channel until all are tested before you begin
running samples.
If you have problems adjusting the baseline readings to within range, see page
19.
Use of biological controls serve as the operational check for the analyzer and Operational
are the basis for monitoring the quality control of the analyzer. See the section
named Control Procedures below.
As part of the normal quality assurance protocol, these checks should be docu- Documentation
mented so they are readily available for review.
As mentioned in the Maintenance and Function Checks section above, calibra- Calibration and
tion testing and adjustments to the analyzer are performed at least calibration verification
semi-annually by trained TEG® users or Haemoscope technicians.
Use of biological controls, which serve as the operational check and calibra- Control procedures
tion verification, is the basis for monitoring quality control of the analyzer and
should be run each shift (or more often, according to your institution’s policy)
before running other samples to assure that all machine settings are within
range. Biological controls should be run each shift to provide a standard of
reference for normal and abnormal coagulation patterns. See the description
of these controls in the section named “Biological control output,” in the chap-
ter named “Quality Assurance” in the TEG® User Manual.
Quality assurance These testing and checking procedures combined with an effective training
summary and proficiency testing program form a comprehensive program of quality as-
surance for the accuracy of the electrical and mechanical output of the TEG ®
analyzer and the reproducibility of the data, and assure compliance of the en-
tire system.
CLIA compliance Compliance with current CLIA regulations, as regarding the TEG® analyzer, is
easily accomplished by simply adhering to the following operational checks
and maintenance guidelines:
Ë Daily:
I Biological controls (operational and calibration verification)
Print tracings, sign, and file.
N Level I (normal) control sample run
N
Level II (abnormal) control sample run
The sample run is considered satisfactory if three out of the four coagula-
tion parameters (R, K, α, and MA) are within the ranges specified in the
product insert.
I eTest testing (electronic)
The following sections describe the maintenance steps that should be per- Hardware
formed at the recommended intervals on the TEG® analyzer: Maintenance
Refer to the picture of the TEG® analyzer (Figure 2) for the location of the Startup and Leveling
parts referenced here:
2. Level the TEG® analyzer according to the bubble level at the top of
the machine by adjusting the thumbscrews at the bottom front (left
and right) and back (center) of the TEG® machine.
SP1
SP2 37.0
AL
MAN 37.0 C
Alignment Frequency:
Ë Semi-annually
Materials needed:
Ë Aligning point
Ë Stopper
Ë Gap gauge
1. Place the aligning point in the cupwell. Be sure that the point is firmly in
place. Place the stopper on the back of the carrier between the two carrier
shafts.
2. Slide the carrier up the carrier shafts until the stopper touches the bottom
of the column.
4. Check that the spindle tip is swinging freely and the points are aligned.
You may need to stop the motion of the spindle by gently resting your fin-
ger against it in order to get a more accurate look at the alignment. If the
points are not aligned, continue with cover removal and x/y adjustment.
To perform x/y adjustment and gap adjustment, you must first remove the
platform and front and side covers on the analyzer.
6. Using an M2.5 hex screwdriver, unscrew the two front screws (Figure
5a - A). Using an M2.0 hex screwdriver, unscrew the two screws lo-
cated at the outer edges of the columns (Figure 5a - B). Using an
M2.5 hex screwdriver, unscrew the two back screws (Figure 5b).
7. While holding down the front base of the machine with your thumbs to
prevent tipping, use your fingers to loosen the side cover so that it can
easily be lifted off. Remove the side cover.
8. Using an M2.0 hex screwdriver, unscrew the three screws that secure
the front cover — one at bottom and two at sides.
9. Cut off the nylon cable tie around the temperature controller bracket
if one is present. Using an M2.5 hex screwdriver, unscrew the two
screws on the back of the level base to disconnect the bracket holding
the temperature controller. Remove the front cover.
Materials
1. Remove the platform and side and front covers as described in the section
named “Removing the covers” on page 11.
2. Check that the machine is level, and, if not, adjust using the thumbscrews
on the bottom front (right and left) and back (center).
3. Make sure the aligning point and stopper are in their proper positions on
the carrier and between the carrier shafts. (See Figure 3.)
5. Using an M2.5 hex screwdriver, loosen but do not remove the two screws
on top of the column.
6. Using an M3.0 hex screwdriver, adjust the alignment through the two set
screws on the front of the column.
7. When the points are aligned and the spindle tip is still swinging freely, al-
ternately tighten the two screws at the top of the column a little at a time,
ensuring that the column remains level. If you align the points but the
spindle tip does not swing freely, you may need to replace the col-
umn.
Materials needed:
Ë Aligning point
Ë Stopper
1. Move the lever into the Test position. Use the feeler gauge to verify
that the gap between the points is between 0.004 and 0.012 inches
(0.1 - 0.3 mm). If the gap is out of range, continue as follows. Other-
wise, skip to Calibration.
3. Remove the platform and side and front covers as described in the
section named “Removing the covers” on page 11.
4. Check the level and make any necessary adjustments using the
thumbscrews located at the bottom front (left and right) and back
(center).
6. Raise and lower the spindle tip by turning the knob located on the top of
the column.
7. When the gap is within range, move the lever back into the Load position.
Adjusting the gap may affect the eTest reading. We recommend that you
check the eTest value before continuing (see the section named “Electron-
ics Testing (eTest)” beginning on page 5). Since coarse baseline adjust-
ment through the column may be needed, leave the covers off until the
baseline has been adjusted.
Calibration Frequency:
Ë Semi-annually
Materials needed:
Ë Disposable pin
Ë Calibration spring
1. Note the rated displacement range (e.g., 20.0 ± 0.2 mm) stamped on the
outside of the calibration spring.
2. Place a disposable pin firmly into the hole located on top of the
spring.
3. Place the calibration spring into the carrier, making sure the base of
the spring is parallel to the carrier (not necessarily flush) and that the
hole located on the bottom of the spring is facing forward.
4. With the lever in the Load position, while making sure the spring is
standing straight in the carrier, slowly raise the carrier until the pin
slips onto the spindle tip and locks into place.
7. Check that the spring is vibrating. If it seems stiff, slide the carrier
down the carrier shafts slightly (usually 1-2 mm) until the spring can
move. Be careful not to pull down too hard or too fast, since the col-
umn is very delicate, especially in Test mode.
10. If the values for the minimum (min) or maximum (max) are 0 or 4095,
adjust the spring using a straightened paper clip or pointed jewelers
screwdriver inserted into the small hole located on the bottom of the
spring. Be sure that the bottom of the spring remains parallel to the car-
rier as you adjust. Turning to the right raises the number, to the left low-
ers it.
11. Check that the millimeters (mm) value displayed by the program matches
the standard on the spring. If any adjustment is needed, use the trimmer
adjustment tool to turn the screw labeled CAL on the back of the machine
that corresponds to the channel you are adjusting. The analyzer is labeled
with arrows indicating which way to turn the screw to increase the reading.
See Figure 16.
After adjusting the number so that it is within range, if the computer does
not issue a message that the calibration is OK, return to the Maintenance
menu, and reselect Spring Calibration, repeating this sequence until the
computer issues a message that says:
Calibration is OK
When calibration is completed, move the lever to the Load position, then Removing the spring
down into the Eject position. Slide the carrier down the shaft and lift the
spring out of the carrier.
Frequency: eTest
Ë Daily (see further description on page 2 under “General quality control.”)
Materials needed:
Message Cause/Remedy
When the reading is within the normal range of 1800-2300, the com-
puter issues the message:
eTest is OK
If the eTest is OK, check the next channel until all are tested before
you begin running samples.
The baseline adjusting screws on the back of the analyzer provide a fine ad- Baseline adjustment
justment. If the baseline value cannot be adjusted through the baseline adjust- through column
ing screws on the back of the analyzer, coarser adjustment is needed through
the column before fine adjustment can be made.
Materials needed:
Ë Flathead screwdriver
2. Make sure that the potentiometer on the back of the analyzer (labeled
Base) is centered before adjusting the baseline through the column. You
should be able to adjust it 7 turns in either direction.
3. Using an M2.5 hex screwdriver, loosen the three screws on the upper col-
umn just enough to be able to turn the gold eccenter screw with a flat
head screwdriver.
4. With the lever in Test position, turn the gold eccenter screw to adjust the
eTest (min) reading to 2000±200 on the computer. Turning the screw
clockwise raises the value, counterclockwise lowers it.
5. Tighten the three upper column screws, alternating among the screws
to keep the column level.
6. Check the eTest (min) value and make any minor adjustments
through the fine eTest adjustment screws on the back of the analyzer.
Materials needed:
Ë Cotton swabs
Ë Rubbing alcohol
3. Slide the carrier all the way down until it drops off the carrier shafts.
4. Remove the carrier and ribbon cable from the TEG® analyzer. Discon-
nect the ribbon cable from the carrier.
5. Clean the ribbon cable with a cotton swab and rubbing alcohol.
8. Use a cotton swab and rubbing alcohol to clean the carrier and the
carrier bottom plate, making sure to clean the connector for the rib-
bon cable.
Materials needed:
Ë Disposable cup
1. Place a disposable cup in each cupwell and fill with tap water. Let
stand for 10 minutes.
2. Insert the wire sensor into the water. Check the temperature of the tap
water, allowing sufficient time (approx. 1 minute) for the sensor to
equilibrate. The temperature difference between the water temperature
and the control display should not exceed ± 0.5ºC.
3. If the tolerance is out of range, adjust the Input Offset Correction. Simul-
taneously press the up arrow (B in Figure 19) and Enter key (C in Figure
19) to access the secondary menu of the temperature controller.
4. If the temperature is out of range for the left carrier, scroll through the
menu by pressing the Index key (A) until you reach the display “InC1.” If
the temperature is out of range for the right carrier, scroll through the
menu by pressing the Index key (A) until you reach the display “InC2.”
Fluke temperature reading higher Raise value of the Input Offset Correc-
than display on temperature controller tion.
To adjust the value of the Input Offset Correction, use the up and
down arrows (B).
5. Press the Enter key (C). The display flashes once.
6. Press the Index key (A) until you return to the Home menu.
Setting the Temperature To set the temperature on the TEG® analyzer, use the control buttons on the
temperature controller.
SP1
SP2 37.0
AL
MAN 37.0 C
A B C
Index key Enter key
Figure 19. Temperature controller
As you set the temperature, observe the top reading which represents the tem-
perature. The columns are indicated as SP1 for column 1 (left) and SP2 for
column 2 (right) below the temperature reading. Remember to wait for the
machine to adjust to your new temperature before using the column you have
set. You can change either column or both.
1. Press the index key (A in Figure 19) once. The column display
changes to SP1. Using the up and down arrows (B), set to the desired
temperature.
SP1
SP2 37.0 C
AL
MAN SP1
Figure 20. Temperature controller
displaying column 1 setting.
3. Press the index key (A). The column display changes to SP2. Press the
index key (A) again to exit. The actual temperature is displayed for
both columns. Wait until the display readout matches the temperature
you set within one half degree before using column 1.
To set column 2 temperature only:
1. Press the index key (A in Figure 19) once. The column display
changes to SP1. Press the index key (A) again. The column display
changes to SP2. Using the up and down arrows (B), set to the desired
temperature.
SP1
SP2 37.0 C
AL
MAN SP2
Figure 21. Temperature controller
displaying column 2 setting.
3. Press the index key (A) again to exit. The actual temperature is displayed
for both columns. Wait until the display readout matches the temperature
you set within one half degree before using column 2.
To set temperature for both columns:
1. Press the index key (A in Figure 19) once. The column display changes to
SP1. Using the up and down arrows (B), set to the desired temperature.
3. Press the index key (A). The column display changes to SP2.
4. Using the up and down arrows (B), set to the desired temperature. Press
the enter key (C). The display flashes once.
5. Press the index key (A) to exit. The actual temperatures are displayed for
both columns. Wait until the display readout matches the temperature
you set within one half degree before using either column.
Replacing
Components
Replacing a Column This section describes how to replace a faulty column on the TEG® analyzer.
Materials needed:
1. Remove the covers from the machine, following the instructions under
“Removing the covers”, beginning on page 11.
3. Disconnect the ribbon cable that connects the column to the small cir-
cuit board on the top plate from the column.
4. Using an M2.5 hex screwdriver, unscrew and remove the three screws on
6. Making sure that the column is straight and that the lever is not attached
to the column, insert the new column into the machine. There is not
much clearance, so make sure you are lowering the column straight in.
7. Once the column has been inserted, level the machine using the thumb-
screws located at the bottom front (left and right) and back (center) of
the machine.
8. Using the open-end wrench, screw the lever back into the column.
9. Procedure for screwing in the upper column base using the torque wrench
(see Figure 24):
I Begin with screw #1 and tighten until the dial moves. Repeat with screw
#2, then screw #3.
I Tighten screw #1 to 0.25 in/lbs. Repeat with screw #2, then screw #3.
I Tighten screw #1 to 1.0 lbs. Repeat with screw #2, then screw #3.
I Tighten screw #1 to 2.0 in/lbs. Repeat with screw #2, then screw #3.
I Check the alignment, gap, calibration, and eTest, and replace covers be-
fore running samples.
This section contains blow-ups of various parts of the TEG® analyzer that de- Mechanical
tail internal components. Illustrations
TEG® Analyzer
Exploded Assembly
Appendix A
Return Shipping Instructions
Before returning your TEG® analyzer to Haemoscope, you must obtain a Re- Obtain RMA and
turn Material Authorization (RMA) number from Haemoscope, which must provide PO
appear on the shipping label and/or the outside of the box.
Please be ready to provide the following information when calling for the
RMA:
Our receiving room will not accept freight collect shipments. A purchase order
number is required for return freight shipping costs, whether or not your
TEG® analyzer is under warranty.
The analyzer must be properly packaged for shipping. You will be charged for Package properly
any repairs caused by improper packaging, which limits claims against the
transporting agency.
Required materials:
Ë Original molded styrofoam support forms. If you no longer have the origi-
nal shipping materials, please contact Haemoscope so that we can send re-
placements.
Ë Tape
1. Move the levers into the Load position. If the analyzer is received at
Haemoscope in the test position, a $500 charge will be auto-
matically added to the P.O.
2. Raise both carriers until they touch the bottom of the columns.
3. Place one end of a piece of tape on the bottom of each carrier, wrap it
over the levers, and attach the other end to the front of the machine. This
prevents the carriers from sliding down and keeps the levers securely in
place during shipping.
4. Raise the feet so that the machine fits into the protective foam.
7. Place the machine into the box with the level bubble facing up.