Whole Blood Coagulation System

Model 8000
.- -
 Intended Use 3

Features 13
Front Panel Layout 15
Special Features 17

Environmental and Safety Conditions 26

Performance Characteristics 27

Suggested Reading 57

Helpful Hints 61
Warranty
.......,................................ .....................................................................................

For In Vitro Diagnostic Use

 he HEMOCHRON' Model poaability and bedside testing
8000 is an interactive, capabilities. A user-friendly display
computer enhanced screen prompts the operator through
instmment designed to the step by step procedure for each
perform an array of whole blood coagulation assay. The dual-channel
coagulation tests. Resulrs are available design of the instrument allows
in minutes. The menu of duplicate testing of the same assay or
HEMOCHROP whole blood assays simultaneous testing of rwo different
includes the Activated Clotting Time assays.
(ACT), Prothrombin Time (PTI,
Activated Partial Thromboplastin Time The HEMOCHRONe Model 8000 is
(APm, Thrombin Time ('IT), Heparin manufacmred and quality assured by
Neuvalized Thrombin Time (HNTl9, skilled technical personnel using high
High Dose Thrombin Time (HiTT), quality testing instrumentation.
Fibrinogen Assay (FIB), Heparin Rigorous standards are used to
Response Test (HRT), and Protamine evaluate and certify each instrument
Response Test (PRT). Since the prior to departure from the factory.
HEMOCHRONmModel 8000 tests fresh The HEMOCHRON* Model 8000 was
whole blood samples, it can be used designed to comply with CSA, LA
for coagulation screening, County, and IEC standards as well as
anticoagulation monitoring and many other state and local codes.
transfusion management. The These approvals are either pending or
instrument may be operated on either issued. Contact ITC Technical Services
Satterf or AC p o m r ro facilitate for h t h e r i~fornmion,
 here are two pathways which be affected by naturally occurring or
together comprise the overall administered procoagulants or anti-
coagulation cascade resulting coagulants, as well as hemorrhagic or
in a stable fibrin dot: the thrombotic clinical events. In order to
intrinsic and extrinsic pathways. determine which element of the coag-
There are twelve clotting factors or ulation mechanism is being affected,
proteins involved in this cascade a panel of coagulation assays are
scheme. They are numbered I through performed. Results of these tests are
XIII, excluding factor VI which was used to differentially diagnose the
initially identified as a new coagulation hemostatic abnormality and to deter-
factor but was later determined to be mine the appropriate therapeutic
the activated form of factor V. intervention.

The intrinsic pathway is so named In addition, to counterbalance the

because all the proteins needed for thrombogenic characteristics of inva-
the entire process are contained within sive procedures such as bypass
the blood. The following clotting surgery or coronary angioplasty, large
factors are unique to this pathway: XI, doses of anticoagulant may be
XI, LX, and V I E Platelets are essential required. Such anticoagulant therapy
co-factors in this reaction, providing must be monitored to adequately
the platelet phospholipid surface on assess the patient's response. For
which the coagulation reactions can optimal dosing of anticoagulants prior
take place. to their administration, dose response
assays can be used to determine
The extrinsic pathway requires Factor patient-specific anticoagulant dosages.
111 (tissue factor) for initiation. This Routine intraprocedural anticoagulant
substance is introduced from outside monitoring can then follow.
of the blood system, hence the
pathway's name. Factor VII is the only The HEMOCHRON" Model 8000
protein unique to this pathway. provides the ability to perform diag-
nostic coagulation tests and obtain
The final step in the coagulation results in minutes to ensure timely
cascade, also referred to as the and accurate assessment of patient
common pathway, is the formation of hemostasis. Anticoagulation moni-
fibrin strands convened from fibrin- toring and transfusion decisions can
ogen in the presence of thrombin. then be made based on the test results
In vivo, the coagulation cascade may obtained.
, ,
he HEMOCHRON" Model no installation procedures. Each
8000 is shipped from the instrument is calibrated during manu-
factory ready for use on AC facturing by a trained technician.
power. Battery operation Test well calibration by the end user
requires an initial eight hour charging need not be performed since the
period since all instrument battery HEMOCHRON" employs fixed calibra-
packs are discharged prior to ship- tion technology. Every time the
ping. Battery charging does occur HEMOCHRON" Model 8000 is turned
during AC power operation, however, on, it performs a series of self-diiag-
the initial charging period is still nostic tests which verify proper
required. function and ensure accurate test
results. The following will appear on
Other than battery charging, the the display screen during the self-
HEMOCHRON" Model 8000 requires diagnostic process:

The results of these self-diagnostic tests will automatically print on the built-in
thermal printer. The Vn.nn designates the software version operating the specific
HEMOCHRON" Model 8000 unit.
 he HEMOCHRON" Model time (TT) test, the heparin neutralized
8000 consists of a clot detec- thrombin time ( H N m test, high dose
tion module and an instruc- thrombin time test (HiTT) and the
tional/data storage module. fibrinogen (FIB) assay. Other tests*
include the heparin response test
The patented clot detection mecha- (HRT), and the protamine response
nism consists of a precision aligned test (PRT) which are part of the
magnet within a test tube and a HEMOCHRON" RxDxe System for
magnetic detector located in each heparin and protamine dosing. New
HEMOCHRONe test well. When the tests are under development, and
HEMOCHRONa coagulation test tube information about them can be
is inserted into the test well, the obtained by contacting ITC at
detector senses the magnet within 800-631-5945.
the tea tube and the tube is slowly
rotated and incubated (37k 0.5" C). Once a coagulation test is completed,
When a fibrin clot begins to form, it test results are displayed as clotting
displaces the magnet within the tube. times in seconds on the LCD screen.
Once the magnet is displaced, it is no For the PT and A P T assays, the
longer sensed by the instrument's instrument also displays a corre-
magnetic detector. The instrument then sponding plasma equivalent result
gives an audible beep and displays which is a calculated value derived
the coagulation time in seconds. from linear regression analysis of
comparative whole blood and plasma
The instructional/data storage module studies. In the case of the PT test, an
prompts the operator through an International Normalized Ratio (INR)
abbreviated set of procedures* for the will also appear on the display.
specific coagulation test chosen from (Please refer to the PTPackage Insert
its menu. On-screen instructions and for a complete explanation of INRI
audible tones are utilized for this
purpose. The operator may record the test
result by selecting from the following
The currently available coagulation options: print the result, store the
testsi for the HEMOCHRON" Model result, print and store the result or
8000 are the activated clotting time simply proceed to the next desired
(ACT) test, prothrombin time (PT) assay. (The HEMOCHRON" Model
test, the activated partial thrombo- 8000 has a fully integrated, high
plastin time ( A P m test, the thrombin resolution thermal printer.)
Principles of Operation (cont'd)

(
Multiole test results can be stored and control values for an entire month.
reviewed for up to five patients. In For more information on quality
addition to test results, patient statis- control please refer to the Quality
tics such as ID#, sex, height and Control section of this manual. A
weight can be easily stored and edited "HELP"file can be accessed at all
prior to performing a test. times to assist the operator in
performing specific functions. A
The HEMOCHRON" model 8000 complete list of "HELP"messages
instructional/data storage module can can be found in the Troubleshooting
also store and print daily quality section of this manual.

*Please refw to thepackage imert of each assayfor completeproduct

information, expected ranges, and testprocedure.
El Provides test results in minutes E# Contains rechargeable nickel
cadmium batteries
Upgradable to include: future test
menu additions and institution- II Auto Shutdown for battery
specific (customized) correlation conservation
charts
II Automatic test well incubation to
E3 Easy to use numeric keypad and 37 * 0.5" C
fixed/display key interface
Visual and audible low battery
Patiendquality control data storage indicator
BI Fully integrated, high resolution Automatically monitors internal
thermal printer providing a copy of circuitry and reports problems/
all test results solutions to display screen
H Interactive graphic display LCD (see Troubleshootin@
screen Multiple microprocessor control for
k3 Displays test results in both whole enhanced reliability
blood and plasma equivalent times
tS4 Internal real time clock and
when appropriate (see Operating
calendar
Instructions)
El Multilingual display option
Performs all dose response
calculations when appropriate P1 AC or battery operation
(see Operating Instructions)
Same HEMOCHRON" test tube
On-screen assistance (HELP) for ail technology as other models
test procedures and data storage
tasks II Whole blood system
Portable system II Unitized, pre-loaded test tubes
FA No calibration or maintenance II Multi-tasking
required
II Two wells for duplicate or
simultaneous testing
 N'TT and PT conversion charts. For

A
11 display keys can be found
below the display screen and complete information on both
all buttons are located to upgrades and custom charts, please
the right of the display contact ITC at 800-631-5945.
screen. Use the "ENTER button
whenever data input is required.
Patient Data Storage
The results of sequential tests or a
HELP Key panel of coagulation tests on an indi-
The "HELP" button is located below vidual patient can be easily stored
the numeric keypad on the right hand along with patient-specific data.
side of the display screen. At any time Stored data is accessible using the
after turning on the HEMOCHRONo "MORE" display key. Before begin-
Model 8000,the operator can depress ning the panel of tests and after
the "HELP" button to obtain assis- turning the instmment on, depress the
tance. The "HELP" function describes "MORE" display key located below
in greater detail abbreviations, the display screen.
commands and procedures found on
the display screen during routine Depress the "MORE" key once again
operation. A summaiy of "HELP" until the "QUIT" display key appears
text files can be found in the and then depress the "QUIT" key.
Troubleshooting section. Depress the "PEOPLE" display key.

If a test or series of tests is being

Upgrade Option pelformed on a new patient, depress
the "NEW" display key. At this point
With the introduction of new coagula- you will be prompted through a series
tion assays, the instructionavdata of instructions to enter the following
storage module of each HEMOCHRONw patient data: Identification Number;
Model 8000 can easily be upgraded to Height; Weight; and Sex. Tables of
include the new tests. To take advan- ently choices are presented. The user
tage of this Upgi-ade Option simply may scroll through the choices by
contact ITC or its authorized local using the up and down arrow display
agent. keys to highlight the desired field.
Pressing "ENTER" selects the high-
This module can also be customized lighted item for use.
to reflect institution-specific plasma
Special Features (cont'd)

After entering this data, you can edit it information includes lot number and
by depressing the "EDlT"display key upper and lower limits for both the
or begin testing by depressing the normal and abnormal controls. This
"QUIT" display key followed by the information does not need to be
"TEST" display key. Test result data entered when subsequent quality
for up to ten patients can be stored control tests are performed as long as
and retrieved by the HEMOCHRON" the quality contvol product lot numbe~
Model 8000 insuument. remains the same.

The HEMOCHRON* Model 8000

stoi-es,per test well, up to 62 discrete
quality control values (31 Normal and
3i Abnormal) obiained from a singie
lot number of quality control product
for each available coagulation assay.
To review any of this QC data, first
choose a test well by depressing the
col-1-espondingtest w-ell starr key.
Then press the " W A T A " display
key and scroll to the coagulation test
of interest using the up and down
arrows.
Quality Control Data Storage
To perform quality control, depress Below is the coagulation test order
the "MORE" and "QUIT" display keys in which QC data is presented:
until the "QC" display key becomes
available and then press "QC". The
"QC" button can be depressed at any
2. ACT-FTCAjlO/CAjlO ABNORMAL
time when a test well is not in use.
The display screen will immnediately 3. ACT-FT/KACT NORMAL
ask which coagulation assay the oper- 4. ACT-FT/KACT ABNORMAL
ator wishes to quality control. After
5. ACT-P214/215 NORMAL
choosing the appvopriate test via the
display keys, the operator will then 6. ACT-P214/215 ABNORMAL
be prompted through data ently 7. ACT-S412 NORMAL
regarding the corresponding ITC
8. ACTS412 ABNORNAI
 9. APTPA103 NOFMAL alphanumeric and graphic display.
10. APIT-A103 ABNORMAL The PRINT hard key can be
depressed at any time the operator
11. PI'-A201 NORMAL wishes to obtain a hard copy of
12. Fl-A201 ABNORMAL display screen information or stored
13. TT-A301 N O B W data provided that ther is a "soft key'
print option on the display. It should
14. IT-A301 ABNORMAL be noted that with all thermal print
15. HNTT-A401 NORMAL paper, images fade over time. In
16. H N n - A 4 0 1 ABNORMAI order to ensure more permanent
records, photocopying the thermal
17. Him-A501 N0lWW.L pint output is strongly recommended
18. Him-,4501 ABNORMAL
19. FIB-B1O1 NORMAL The HEMOCHRON" Model 8000 can
automatically print test results at all
20. FIB-B1Ol ABNORMAL times. The operator has the option
of enab!ing/disab!ing this feature as
desired. Before beginning the panel
of tests and after turning the instnt-
nlent on, depress the "MORE"
display key. Depress the "MORE"
key once again until the "QUIT"
display key appears and then
depress the "QUIT" key. Now press
ihe "SET-'t' displzy key. Once
again, depress the "MORE" display
key. Now the operator can choose
print options.

Depress "PSEWECT display key. To

shut the printer off, depress "OFF";
to leave the printer on, depress
I Thermal Printer "ON.

The HEMOCHRON" Model 8000 Depress "P-AUTO"display key. To

incorporates a high resolution have the i~~strucnent output all test
themla1 printer capable of both results to the printer, press "YES"
Special Features (cont'd)

(
(this option is negated if the operator To remove the paper roll:
has shut the printer off in the 1. Open printer cover
"P-SELECT"mode). To eliminate 2. Lift upwards from the bottom
this option, press "NO". of the roll
3. Unseat the roll bar from the
printer well
4. GentIy slide remaining paper
out of the printer inlet
5. Slide the roll bar out of the
paper roll core

To install the paper rolk

Depress the "PIEST" display key to
test the functionality of the printer. A 1. Printer cover must be opened
three line print test will output all 2 . Remove protective plastic from
alphanumeric characters. the new roll
3. Unroll a length of paper
The "PAPER"button is used to 4. Fold or cut a "V" at the
advance the printer one line at a time beginning of the paper
and feed paper past the cutting edge 5. Position roll so that paper
for easy printout removal. unrolls from the bottom in the
well
6. Slide the paper rod into the
Loading Printer Taper new paper roll core
The HEMOCHRONmModel 8000 7. Place the roll bar over the
thermal printer is located under the mounting slots
printer cover located on the top of the 8. Press downwards until the
instrument. The cover may be opened paper rod snaps into the slot
by gently pushing the latch tab 9 . Remove any slack in the paper
towards the rear of the unit and lifting feed by rolling excess paper
the cover upwards. The printer mecha- back onto the roll
nism and the paper roll will now be 10. Thread the paper through the
visible. The heat sensitive paper is cutting slot of the printer cover
suspended on a roll bar that is friction-
11.Close the cover
fit into the printer well slot. The
printer must not be printing while 12. Tear off excess paper and
resume normal use
 Clock and Calieln
To set the clock or calendar, the oper-
ator simply depresses the "MORE"
display key until the "QUIT" display
key appears and then presses the
"QUIT"key followed by the "SET-UP"
display key. Now choose "TDIE"
display key to set the "CLOCK" or
Auto Shut Down
"DATE" display key to set the
The HEMOCHRONmModel 8000 will calendar. Choosing the "CLOCK"
automatically stop test well incubation display key allows the operator to
and rotation if no test tuhe is inserted display either a 24 hour clock with a
into the well within 60 seconds of seconds display or a 12 hour clock
depressing the "START" display key. with an "AM/PM designation.
This feature is intended to conserve
battery life and to ensure accurate test
results. Test Options
When not in use for a specified period While in the SET-UP mode, depress
of time, the HEMOCHRON" Model the "MORE" display key until the T.
8000 will "go to sleep" while retaining OPTS display key is presented.
all stored data. SLEEP reduces power
to the LCD screen. This feature is also
designed for battery conservation. The
HEMOCHRON" Model 8000 is prepro-
Ail tests performed in a given day are
grammed with a default 20 minute
automatically sequenced beginning
SLEEP setting. To set this period of
with the number one. However, if the
t h e , the operator simply depresses
operator wishes to alter this automatic
the "MORE" display key until the
sequencing at any time, he/she may
"QUIT" display key appears and then
do so by choosing the Test Sequencing
presses the "QUIT"key followed by
option. For instance, if three patients
the "SET-UP"display key. Now
are each having five tests performed
choose SLEEP option and enter a time
in the morning and again in the after-
limit in minutes. The range for this
noon, the operator may want the tests
entry is 2-99 minutes.
of each patient to be sequenced one
Special Features (cont'd)

to ten. Therefore, after completing the The SW designates the current

first five for patient one, choose the HEMOCHRON' 8000 application soft-
"T-SEQP display key and enter the ware version. TW is for the current
number one. Now the first five tests Test Well and PC is for the current
for patient two will be numbered from power controller version.
one to five. Later in the afternoon, the
number six will be entered under the
Screen Control
"T-SEQ#"option so that the subse-
quent five tests will be numbered six The operator may alter the contrast
through ten. and brightness setting for the LCD
display screen by choosing the
"SCREEN" display key while in the
SET-UP mode. Up and down arrows
The instructional module that prompts can be pressed to increase or decrease
and assists the operator, via on-screen both contrast and brightness to the
text display, in the proper use of the desired levels.
HEMOCHRON" Model 8000 will be
available in multiple languages. To
access the language options, the oper-
Fan Control
ator simply depresses the "MORE" The cooling fan located in the rear of
display key until the "QUIT" display unit will automatically operate when
key appears and then presses the the instmment is being run on AC
"QUIT"key followed by the power. While the unit is running on
SET-UP display key. Two additional battery the fan will not automatically
presses of the "MORE" display key operate. Using the fan control key will
displays the LANG option. To obtain allow the user to manually turn the
information on this upgrade, contact cooling fan on or off.
ITC at 800-631-5945or 908-548-5700.

Beeper On/Off
SYSVFiK (System Version)
The operator may select this key to
The operator can view the cument disable/enable all audible tones
revisions of the software within the during test operations.
unit. By pressing the "SYSERV"
display key, the following is
disolaved:
 Protective Conductor Terminal
(Ground)

2 Standby Switch

Connections

1 9 Auxiliary Serial Port

2 25 Auxiliary Parallel Port

Number of test channels
Timing Range (seconds)
Incubation Temperature PC)
Battery Charge Time (hours)
Operating Time o n Full Battery 6 hrs (Sleep Active, 4 ACTshr)
Line Voltage (volts AC) 120
(100, 220, 230 optional)
Input Voltage (volts DC)
Frequency (Hz)
Display Screen LCD, CGA video display 200 lines x
320 columns

Printer High Resolution, mockilar 3

inch rhermal recorder with
alphanumeric and graphic display
Central Processing Unit Intel 386SX; 256Kb ROM; IMB RAM; 1 6 ~ h z
Expected No. of Recharges
Before Battery Replacement
Dimensions (w x d x h, inches)
Weight (pounds)

Sample Throughput Variable. See each package inseit

for clotting time ranges.
CL~ Z volts)
(100-240 - 1 amps
Fuse (100-120 volts) 250V. 2.OA. 3AG SLO-BLO
Fuse 1190-2.10 volts1 1. 250V, l.OA, 1 AG SLO-BLO
2. 250V, 1.OA, 1 AG SLO-BLO
 (
he HEMOCHRON" Model The user shall be made aware
8000 Instrument was that, if the instrument is used in a
designed to be safe at manner not specified by ITC, the
least under the following protection provided by the instru-
conditions: ment may he impaired.
$I indoor use
$I altitude up to 2000 m The operator should position the
$I operating temperature instrument so that it is not difficult
15"Cto26C to disconnect the power cord at
g relative humidity 20% to 80% the appliance inlet.
transient overvoltages to
INSTALLATION CATEGORY I1 There are NO hazardous
g pollution degree 2 in accor - substances specified within the
dance with IEC 664 instrument manufactured bv ITC
 a ristics
he charts below provide complete list of available assays,
performance data on the please contact ITC. Always refer to
ITC coagulation assays most the specific assay's package insert for
often performed on the detailed product information.
HEMOCHRONe Model 8000. For a
Performance Characteristics (cont'd)

' Expected values for cardiovascular patients are different than for normal, healthy persons with
CA510lFTCA510/K-ACT/FIX-ACTtubes.
Please refer to the lnsmction card and/or package insert included in each box of HEMOCHRONo
test tubes for details on product use.
Each institution should establish its own nonnal range of response and the appropriate target range
to ensure adequate anticoagulation for its own patient population.
Whole Blood to Plasma which may be used to calculate the
Conversions corresponding plasma equivalent
result from any whole blood result.
The HEMOCHRON* Model 8000 is Details of these equations and whole
programmed with plasma equivalent blood to plasma conversions may be
APTT and PT values for the whole found in the HEMOCHRON" APTT
blood A P T and PT tests, respectively. and PT package inserts.
Plasma equivalent values are calcu-
lated values obtained from a linear Plasma APTT and PT values are
regression analysis of comparative specific for a given APTT or PT
studies in which whole blood determi- reagent and instrument system.
nations and plasma determinations are Different reagents demonstrate diverse
performed simultaneously on patient normal ranges and sensitivity. Plasma
or normal donor samples. Based on equivalent values are approximate
the clotting time results of these values for use in the clinical setting.
comparative whole blood and plasma A more relevant conversion may be
tests, an XI graph is generated. Linear obtained by each institution through
regression analysis is used to define performance of whole blood/plasma
the correlation of the whole blood comparative studies, as described in
and plasma results. Based on this the respective package inserts.
analysis an equation is generated
 he HE?MOCHRONa Model 8000 is ON, the LED will remain lit until the
may be operated either on its "sleep time" is reached. When the
self-contained battery or "sleeptime" is reached, the display
plugged into the appropriate will dim to half-intensity and the red
AC outlet. Routine charging and LED will blink. This feature reduces
discharging of the nickel cadmium battery drain and consen7espower.
battery will improve its life-span. Pressing ANY front panel key, except
Therefore, if batteq~use is desired, it is ( 6 ) will return the instrnment to
recommended to dischai-gethe battery normal operating mode.
during clinical use and plug the unit in
at night or when the Model 8000 is not A cooling fan located in the rear of
in use. Coagulation tests can be the unit will operate only while the
performed on the instmment while it is HEMOCHRONe Model 8000 is being
charging. run on AC power. It will not run while
the unit is on battery power in order to
The instructional program found inside conserve battery life.
the HEMOCHRONVModel 8000 consists
of three menus or "logic trees". The Every time the HEIMOCHRON" Model
most co~nmonlyused is the TEST menu 8000 is turned on, it performs a series
which prompts the user through the of self-diagnostic tests which verify
proper procedure for either quality proper function and ensure accurate
control or the specified coagulation test results. The following will appear
assay. The other menus are the PEOPLE on the display screen during the self-
Menu, which allows the operator to diagnostic process:
store test data for up to five patients,
and the SET-UP menu, which allows
INTERNATIONAI TECHNIDYNE CORI'ORATION
the setting of the internal clock and
HEMOCHRON* MODEL 8000 V n n n
calendar along with other options
described in this and the Features SYSTEM CHECKS
section of the manual. PROGRAM VERIFICATION
CALIBRATION WELL ONE
To begin using the HEMOCHRON" CALIBRATION WELL TWO
Model 8000, push the power button HEAT WELL ONE
( 6 ) located on the front of the instru- HEAT WELL TWO
ment. A red LED below the switch will VIDEO SCREEN
then illuminate. When the inst~mment PRINTER
 Operating Instructions (cont'd)

The results of the self-diagnostic test FAIL does not stop the system from
will automatically be printed on the operating but all printer functions are
built-in printer. automatically disabled. A FAIL on any
other checks will stop instrument
The Vnmn designates the software
operation. If a F A U occurs contact the
version operating the specific
ITC Technical Service Department
HEMOCHRONmModel 8000 unit.
immediately.
The SYSTEM CHECKS will verify
After automatically performing internal
system memory and report OK if
diagnostic procedures, the
successful or a NUMBER for the failed
HEMOCHRONmModel 8000 is ready
memory location.
to run the desired coagulation test.
The PROGRAM VERIFICATION Tne ALCTIW test well screen appears
compares the internal program identi- white with a double frame border.
fication number to the loaded program The INACTIVE test well screen
identification number on the memory appears dark with a single frame
card to determine if the system has border. To choose a test well, depress
been installed correctly. The CALI- the hard START key corresponding to
BRATION WELL ONE/TWO display the desired test well.
reports OWFAIL if the wells are cali-
brated properly. The HEMOCHRON" At any time during use of this instru-
Model 8000 is calibrated at the factory ment, the operator may depress the
prior to shipping so OK should be "HELP" button for clarification or addi-
displayed. tional instructions. The "QUIT" display
key allows the operator to stop and
The HEAT VYELL ONE/TWO message start again at any point in the opera-
displays OK if the heaters are oper- tion of the instrument. The "ENTER"
able. The VIDEO SCREEN message is button is used for all data input.
for video memory tests and displays
OWFAIL. A failure will be apparent
becausethe display will not function SET-UP Menu
and no message will be observed. The Before performing a specific assay, the
PRINTER message checks for printer operator may want to review and/or
operation as OWFAIL. An OK means change the default settings of certain
that the printer is operable while a automated options. The following
FAIL means that the printer sub- options are found under the "SET-UP"
system is not functional. A P m R menu: 'TIME", "DATE", "CLOCK",
"SLEEP", "PSLECT", PAUTO", and keys will then appear. The first two
"WG''. For more information on choices are discussed in the Features
these options refer to the Features section.
section of this manual.
If a test or series of tests is being
To access the "SET-UP"menu, performed on a new patient, depress
depress the "MORE" display key until the "NEW" display key. At this point
the "QUIT"display key appears. you will be prompted through a series
Depress the "QUIT" key and the of instructions to enter the following
"SET-UP"menu key will appear. patient data: Identification Number;
Depress the "SET-UP"key and the Heighr; Weight; and Sex. When
first set of options displayed will be entering Height, Weight and Sex,
"XIME", "DATE", "CLOCK, and tables of entry choices are presented.
"SLEEP The user may scroll through the
choices by using the up and down
Pressing the "MORE" display key
arrow display keys to highlight the
shows additional choices. They are
desired field. Pressing "ENTER
"PSLECT","P-AUTO", "FTEST", and
selects the highlighted item for use.
"LANG". The Feahlres section also
explains how to set all of these options After entering this data, you can edit
Pressing the "MORE"display key will it by depressing the "EDIT" display
continually scroll through all of the
key.
option choices. Press the "QUIT"
display key to exit the "SET-UP"
menu

PEOPLE Menu
The top level display screen offers the
operator the following menu choices:
"TEST"; "PEOPLE";and "SET-UP".If
an assay or series of assays to be
performed are on a single patient and
storage of these test results is desired,
the operator should choose the The "REVIEW" key allows the oper-
"PEOPLE" menu. "NEW', "EDIT", ator to review the statistics (ID#,
"REVIEW" and "RE- display Height, Weight and Sex) of all of the
Operating lnstructions (cont'd)

i
patients currently being stored. If an incubation step is required to
Remember, only ten patients can be complete a particular test (e.g.,TT,
stored at one time. Therefore, before HNTT, Hi'IT, FIB), the HEMOCHRON"
entering a new patient be sure to Model 8000 will prompt the operator
create a permanent record of the of this requirement once the test
earliest patient since that data will be procedure is displayed. The instru-
deleted. The "VUDATA" Display Key ment will automatically begin and
allows you to review test results. time the incubation when appropriate.
Pressing the "RECALL" display key An audible tone will be heard by the
displays the IDii's for the ten stored operator when the end of the incuba-
patients in chronological order. tion period is approaching.
Pressing the "ENTER key selects the
highlighted ID number as the active Common to all ITC coaguiation test
patient. The earliest entered patient is tubes is the magnet and plastic center
at the top of the list. post. Once the appropriate blood
sample and reagents are in the test
TEST Menu tube and after any required incubation ('
step, the display screen will instruct
Depressing the "TEST" display key the operator to depress either the
shows the coagulation assays currently "START" button adjacent to the
available for the HEMOCHRON" appropriate test well or the "START"
Model 8000. Press the "MORE" display display key to begin the test. When
key to review all choices. Choosing the test tube is inserted L~tothe test
a particular test results in a series of well, the magnet positions itself
prompts that review the test procedure directly above the detector. To assure
to be performed. this positioning, the operator should
rotate the test tube two full revolu-
For example: tions clockwise while verifying that
the DETECTOR light is on and
User Presses: FIB
remains illuminated. The
Display Shows:
HEMOCHRON" Model 8000 requires
DILUTE UNDILUTE QUIT
that the DETECTOR light is stable for
at least 15 seconds within the first 60
The operator now enters the blood
seconds for a valid start.
(
sample type being used and the
HEMOCHRONa Model 8000 automati-
Once a clot is detected and the test is
cally displays the test procedure.
completed, an audible tone will emit
and the clotting time will flash on the The xaSystem Tese
display screen. For the HEMOCHRONm
APTT, PT tests, the appropriate A unique series of assays for use
plasma equivalent result will also during cardiopulmonary bypass
appear on the display. In the case of surgery and cardiac catheterization
the PT test, an International procedures comprise the RxDxa
Normalized Ratio (INRI will also System. This system is accessed in the
appear on the display (Please refer to TEST menu under the "RxDx"
the PT Package Insert for a complete display key. Calculations required to
explanation of INR.) The test result perform the RxDx" System are done
will remain illuminated on the screen automatically and the results are
or until the next test is initiated in that displayed by the HEMOCHRON"
test well for the length of time the Model 8000. It is strongly recom-
operator entered under the SLEEP mended that the operator refer to the
mode (see features). detailed RxDx" Package Inselr for a
complete discussion of this unique
and useful heparin and protarnine
dosing system.
HEMOCHRON MODEL 8000
 Example Screen

HEMOCHRON MODEL 8000

EDIT PATIENT INFORMATION

I

~ e k h t 145
: 66
Sex : M

IDENTIFICATION NUMBER:
 ata is alculation
Example Screen

HEMOCHRON MODEL 8000

HRT TEST RESULTS

PATENT ID# = 1010

SEX = MALE

TARGET TIME = 480 Seconds

BASELINE ACT = 124 Seconds
HRT = 247 Seconds

I TEST COMPLETE - MAKE A SELECTION

 stablishing a quality control both normal and abnormal control
program is recommended for plasmas for the FIB assay. Complete
all in vitro diagnostic products records of quality control data must be
The HEMOCHRONmModel kept. For more complete information
8000 and coagulat~onassays should on the HEMOCHRON" Model 8000
be quality controlled using two levels QC data storage capability, please
of control and performed daily once refer to the Features section of this
per shift. Routine quality control manual.
testing and tracking should be part of
a comprehensive quality assurance The temperature of the HEMOCHRONa
program and complete records of Model 8000 test wells can also be veri-
quality control data must be kept. ITC fied externally with the use of the
products for quality control are avail- Temperature Verification Test Tube
able to make routine QC convenient (HE1001) as part of a quality control
and affordable. These products are program. The temperature of each test
especially beneficial when an instru- well is internally calibrated to be
ment problem 1s suspected. We maintained at 37 f 0.5" C. Verlfy
recommend that multiple tests be run temperature with the Temperature
with ITC control plasma before Verification Test Tube every 6 months.
requesting service from ITC.
HEMOCHRON" Quality Control prod- If an instrument does not perform as
ucts include the CPL-Normal, CPL- described in this manual and QC
Abnormal Level I, and CPL Abnormal values are out-of-range, patient results
Level I1 for the ACT tests, and 4101- should be considered invalid. Repeat
?Toma! and Q101-Abnorr.al for the 6.e test. If the prob!em persists, please
HEMOCHRON" APTT, PT, TT, HNTI contact ITC Technical Service
and HiTT assays. HEMOCHRON" Department at 800-631-5945 for
Quality Control Product B102 provides instructions.
 he HEMOCHRON" Model designed for use only with
8000 should be plugged into HEMOCHRON" coagulation assays
the proper AC outlet when and quality control products. Other
not in use to maintain the commercially available blood collec-
battery power level. To unplug the tion test tubes lack material and
instrument, firmly grasp the plug and components necessary for clot detec-
pull. DO NOT remove the plug from tion in the HEMOCHRON" Model
the outlet by pulling on the cord. 8000.

Always plug the instrument into a In a properly maintained and oper-

properly grounded, three pronged ated instrument, the accuracy and
receptacle. DO NOT use non- precision of test results are largely
grounding adaptors. dependent upon the quality of the
blood specimen used for the test.
DO NOT force test tubes into the test Factors such as specimen contamina-
wells. If resistance to insertion or rota tion, inappropriate technique, or large
tion is encountered, gently remove temperature variations will adversely
the test tube and examine the test affect most coagulation tests.
well. Remove any obstruction before
attempting further use of the instru- Test results should always be scruti-
ment (see Service and Maintenance nized in light of a specific patient's
section). condition or anticoagulant therapy.
Any test result exhibiting inconsis-
DO NOT use excess force in tency shouid be repeated or supple-
depressing any of the operating keys. mented with additional test proce-
dures.
DO NOT expose the analyzer to
extremes in temperature. Such expo- HEMOCHRON" Model 8000 test
sure may affect all types of solid state results greater than 1500 seconds
instrumentation. should be considered beyond clinical
significance and the test should be
DO NOT drop the HEIMOCHRON~ immediately repeated. All guidelines
Model 8000. pertaining to the handling of fresh
whole human blood, such as CDC
As with all microprocessor controlled guidelines, should be strictiy adhered
instrumentation, exposure to static to when operating this instrument.
electrical charges should be minimized. Also refer to NCCLS standards H21A2
The HEMOCHRON' Model 8000 is and H29A2.
Operational Cautions and Limitations (cont'd)

in fire, or mutilate; may release toxic

Use of this equipment other than in materials. Do not shoa circuir; may
accordance with the manufacturer's cause burns.
guidelines is not recommended and is
at the sole discretion of the institution.

i
Service a
nspect and clean the test well and daytime hours. Plug the instrument
test tube drive collar. Remove into rated AC voltage overnight to
residual blood or other foreign allow the batteries to recharge. The
matter using a 1:10 dilution of nickel cadmium battery cells work best
household bleach (0.5% sodium when they are exercised in this
hypochloride) with moistened cotton manner.
swabs.
A fully charged battery will operate the
Apply solution to clean and disinfect instrument for four to six hours of
areas contaminated with residual dried ~ontinuoususe. A low battery indi-
blood. DO NOT use solvents or strong cator graphic will appear on the
cleaning solutions. They may deform display screen along with an audible
the instrument's plastic components. tone when approximately 20 minutes
of battery life remains. This audible
The HEMOCHRONe Model 8000 is tone will repeat when there is only ten
almost completely self-monitoring. minutes of battery life remaining and
It automatically monitors internal again at five minutes. Once the first
circuitry and reports problems to the indicator is observed, the operator
display screen. The HEMOCHRONa should plug the instrument in at the
Model 8000 has a fixed calibration earliest possible convenience.
system. All instruments are fully cali-
brated and tested before shipping. When the batteries are drained to the
Calibration status is also automatically point that valid testing cannot be
moniiored as noted abo-ve. JL?y cali- perfo.~.ed, fhe instnlment will display
bration error will be signified by an a battery fault message. At this point
on-screen error message. After diag- the instrument must be plugged in for
nosing a calibration error, immediately operation and recharging. Whether or
contact ITC Technical Service depart- not the instrument's batteries are func-
ment. tional, the operator will not be incon-
venienced by downtime because tests
To optimize battery life, it is reconl- can still be run while the analyzer is
mended that one use the HEMOCHRONe plugged into AC power.
Model 8000 on its battery during
Below is a listing of the more common HELP messages available to the operator
during regular use of the HEMOCHRON" Model 8000. After reviewing the HELP
messages, depress HELP key to return to original menu.

1. Depressing the HELP key inTEST Menu

Tests Supported
ACT Activated Clotting Time
APTT Activated Partial firomboplastin Time
PT Prothrombin Time
'IT Thrombin Time
HiTT High Dose Thrombin Time
HNTT Heparin Neutralized Thrombin Time
FIB Fibrinogen Assay
QC Quality Control Tests
MORE Go to Next Menu Screen
QUIT Return to Previous Menu
RxDxmSystem:
HRT Heparin Response Test
SUBHEP Subsequent Heparin Dose
CIRHEP Circulating Heparin Level
PRT Protamine Response Test

2. Depressing the HELP key in PEOPLE Menu

NEW Enter a new patient profile

EDIT Edit selected patient profile
REVIEW Review active patient profiles
RECALL Get a previous entry and
make it active
HELP Feature (cont'd)

1. Depressing the HELP key i

n SET-UP Menu

TTME Set system time

DATE Set system date
CLOCK Select clock display
SLEEP Set sleep time
PSELECT Printer select
P-AUTO Printer automatic
P-TEST Printer test
T-OPTS Test option defaults...more
T-SEQ * Test sequence number
LANG Language selection
SYSVER System version
BATLEV Battery Level
BEEPER Control Beeps
FAN Control Fan
SCREEN Screen adjustment
MORE Go to next menu screen
QUIT Return to previous menu
 HEMOCHRONe Model No. Serial #
Calibration verifiication performed by: Date / /

The foJlowing procedures should be Well Temp. Good NotGood

performed at the minimum frequency
required under CLIA. Presently, the
CLIA requirement states that
verification procedures should be
~erformedevery six months. The
results may be recorded on this sheet h observed temperature deviation of
which can be xeroxed for repeated use. +
greater than 0.5"C from 37" C
suggests the necessity of instrument
I. Test Well Temperature recalibration. In this circumstance,
return the instrument to ITC with a
The incubated HEMOCHRON" test description of the fault.
well is designed to control the test
tube environment at 37°C c 0.5"C. This
is verified as follows:

Charge the HEMOCHRON'

sinsurment battery fully.
Insert the HEMOCHRON"
eTemperature Calibration Tube Heat thermometer by running hot
(Cat. #HE1001) into the HEMOCHRON" ap water over the bulb portion of
test well and depress the START key. ennometer Continue to heat
The green detector light should until the void separating the column
illuminate and remain lit for the entire completely enters the top reservoir."
temperature calibration procedure.
Allow the instrument to come to Immediately tap or jar ther-
thermal equilibrium for at least 10 ~amometeron a cushioned surface
minutes. holding it in an upright position to
force the mercury ro join.
Without removing the calibration
*test tube from the test well, read Repeat if necessary. If mercury
the temperature and record it on the rcolumn does not move or "runs",
.- chart below
mercury separations may be the result
Repeat steps 2 and 3 for the of a broken thermometer tube.
ssecond test well. *Caution: Do not aUow the mercury
to till the reservoir completely as it
will cause thermometer to break. %'
II. Clot Detector Sensitivity .Timer Accuracy
The sensitivity of the clot detection The accuracy of the timing function is
mechanism is checked as follows: checked as follows:

If the instrument is in the battery Insert any unused HEMOCHRON-

sconsemation mode (blank display etest tube into the test well and
screen), depress the START button twice simultanously depress the START button
to begin the timer. on the HEMOCHRON" instrument and
start a stopwatch or timer. Ensure that
the green detector light is illuminated
Insen an unused HEMOCHRON" and remains on.
atest tube in the test well, rotating
the tube twice gently clockwise, ver@-
ing illumination of the green detector Simultaneously remove the
light. rHEMOCHRONe test tube from the
test well when the counter reaches 180
seconds and stop the stopwatch or
Wait 25 seconds, then slowly rotate timer. Record the elapsed time on the
*the entire instrument counter-dock chart below.
wise onto its left side as viewed from the
front. At 70 degrees from its normal
horizontal position, the instrument Repeat steps 1 and 2 for the second
should sound and flash the time on the .test wefl. (Not applicable to Models
display screen. Record the result on the 400/401).
chart below.

Repeat steps 1 to 3 for the second Well time (sec) Good Not Good
c test well. (Not applicable to Models #1 [ I [ 1
400/401).
; A [ 1 [ 1
Well Good Not Good

-1 [ I [ I
+“2 [ I [ 1

If the instrument does not perform as

described, contact International
Technidyne Corporation for servicing
instructions.
 efore attempting repairs, dropped. Get a description of the
perform a careful inspection of malfunction and confirm it by running
the instrument. A visual exami- Your own test using an empry
nation can frequently pinpoint the HEMOCHRONa test tube.
defect, especially if the unit has been

A. Long Clotting Times - Too much heparin

present
Test a second specimen
to verify result5
Incubator circuit or test well Send to ITC Technical
malfunction Service Department.
Test tube does not rotate Send to r C Technical

-
Service Department.
B. Short Clotting Times Tubes not mixed Recheck technique.
properly Test a second specimen

- Tubes not turned

to verify results.
Recheck technique.
Test a second specimen
to vcri£y result%
Tubes not turned twice Recheck technique.
after green light illuminates Test a second specimen
to verify results.
Battery may be discharged Check battery.
C. Battery Will Not Charge . AC FuseW blown Repiace h e .

-- Bad cell in battery

Charging circuit malfunction
Defective line cord or plug
~ ~
Check error message.
Check enor message.
Contact ITC Technical

-
Service Department.
D. Green Light Instrument Lock-Up Contact ITC Technical
Remains On Service Department.
After Tube is
Removed
E. Green Detector Light
Does Not Illuminate
. Tubes not mixed
Tubes not rotated twice
Recheck Technique.
Test a second specimen.
after insertion into test well
Detector sensitivity error Contact ITC Technical
Service Deparunent.

continued on nextpage
Troubleshooting (cont'd)

F. Tube Does Not Rotate Motor physically damaged Contact ITC Technical
(this usually occurs when an Service Department.
instrument has been dropped)
Motor pulley is stripped o n Contact ITC Technical
the nlotor shaft Service Department.

Wires to motor are broken Contact ITC Technical

or clisconnected Service Department.

Test wsll and namepiarc are Contact ITC Technical

misaligned Service Department.

G. Unit Does Nor Srart When

Key Is Depressed
. Farteiy fully discharged Plug in ancl charge
battery.

AC Fuse(s) blown Replace fuse.

H. Unit Does Not Run

When Operated in
- Power Controller
Fuse Blown
Send to ITC Technical
Service Department.
the Battery Mode (10 Amp)
h e following on-screen error messages may appear as a result of the
internal diagnostic procedure. Cause and action to take is provided
with each message.

Test well temperature Contact ITC Technical

below acceptable le\.e! Service Department.
Test well under heated.
Test well temperature Contact ITC Technical
above acceptable level. Service Department.
Test well overheated.
Automatic shut-off. Repeat test being
Timer exceeded performed. If data
1500 seconds. inconsistent with patient
condition, perform
quality control. If no
test being run, no action
necessary.
Clot detection sensitivity Contact ITC Technical
not set. System not Service Department.
calibrated.
Bias current calibration Contact ITC Technical
error. Service Department.
Banery error. Charge battery for 8
hrs. If fault persists,
contact ITC Technical
Service Department.
Internal diagnostics error. Contact ITC Technical
Service Department.
 este
1. Bergqvist D, Arborelius M, Fredin H, Hellekant C, Modig J: Venous thrombosis
and pulmonary embolism. In: Renck H (editor): Bleeding and Thrombotic
Disorders in the Surgical Patient. Appleton and Lange/Mediglobe, 86-100, 1988.

2 Brinkhous K, Langdell R, Penick G, Graham J, Wagner R: Newer approaches to

the study of hemophilia and hemophilioid states. JAMA 154:481, 1954.

3.9~11BS, Korp=an RA, Huse WM, Briggs BD: Heparin therapy during extracor-
poreal circulation: I. PI-oblemsinherent in existing protocols. J Thorac Cardiovasc
Surg 69:674-684, 1975.

4 Doty DB, Knott EEV, Hoyt JL, Koepke JA: Heparin dose for accurate anticoagu-
latlon in cardiac surgery. J Cardiovasc Surg 20:597-604, 1979.

5. Esposito RA, Culljford AT, Colvin SB, Thomas SJ, Kackner H, Spencer FC: The
role of the activated clotting time in heparin administration and neutralization for
cardiopulmonry bypass. J Thorac Cardiovasc Surg 85:174-185, 1983.

6. Gambino R: Monitoring heparin therapy. Lab Report for Physicians 437-20,

1982.

7. Hattersley P: Activated coagulation time of whole blood. JAlVIA 136:436, 1966

8. Hattersley PG: Heparin anticoagulation. In: Koepke ;A <editor>:Laboratory

Hematology. Churchill Livingstone, 789-818, 1984.

9. Hill JD, Dontigny L, deLaval M, Mielke CH: A simple method of heparin

management during prolonged extrcorporeal circulation. Ann Thorac Surg 17:129-
134, 1974.

10. LaDuca FM, Thompson S, Larson K: Neutralization of heparin using a

protamine titration assay and the activated clotting time test. AmSECT Proc 19:358
364, 1987.

11. Langdell R, Wagner R, Brinkhous K: Effect of antihemophilic factor on the

one-stage clotting test. J Lab Clin Med 41:637, 1953.
12. Lee RI, White PD: A clinical study of the coagulation time of blood
Am J Med Sci 145:495-503, 1913.

13. Lindsay RM. Practical use of anticoagulants. In: Drukker W, Parsons FW,
Maher JF (editors): Replacement of Renal Function by Dialysis. Martinus Nijhoff
Publishers, 201-222, 1983.

14. Miale JB: Laboratory Medicine-Hematology, Fourth Edition. The Mosby

Company, St. Louis, Missouri, 1267, 1972.

15. Miller DW Jr., Binford JM, Hessel EA: Results of a survey of the professional
activities of 811 cardiopulmonary perfusionists. J Thorac Cardiovasc Surg
83:385-389, 1982.

16. National Institutes of Health Consensus Development Conference Statement:

Prevention of venous thrombosis and pulmonary embolism. 1986.

17. Ogilby JD, Kopelman HA, Klein LW, Agarwal JB: Adequate heparinization
during PTCA: Assessment using activated clotting time. JACC 11:237A, 1988.

18. Rward DC, Thompson SJ: Demonstration of heparin reversal with protamine
administration using an automated protarnine dose assay: Comparison of two
methods. ArnSECT Proc 20:63-64, 1988.

19. Sanders PW, Curtis JJ: Management of anticoagulation for hemodialysis, In:
Nissenson ARE,Fine RN (editors): Dialysis Therapy. ,The C.V. Mosby Company,
39-41, 1986.

20. Schriever HG, Epstein SE, Mintz MD: Statistical correlation and heparin sensi-
tivity of activated partial thromboplastin time, whole blood coagulation time, and
an automated coagulation time. Am J Clin Path 60:323-329, 1973.

21. Scott JA, Berenstein A, Blumenthal D: Use of the activated coagulation time
as a measure of anticoagulation during interventional procedures. Radiology
158:849-850, 1986.

22. Transfusion alert: Indications for the use of red blood cells, platelets, and
fresh frozen plasma. NIH Publication No. 89-2794a, May 1989.
 My 8000 does not print after each test unless I push the manual print
button.
The print mode on the 8000 is programmable and can be turned on or off by
going into the proper inode. (see "Special Features" section in Owners Man~ral)

My screen is not bright enough when I turn on my 8000, can I make it

brighter?
Yes, the model 8000 has an adjustable LCD screen and it can be adjusted in
the SETUP menu. lnstrvments are set to inaximum brightness before they are
sent from ITC. (see "Special Features" section in Owners Manual 1

Can my 8000 be programmed in any other language except English?

Yes, the 8000 can be upgraded to a different language provided we have the
translation program For more information, call ITC (800) 631-5945.

When I convert my whole blood value to a plasma conversion, 1get a

"0"on the screen?
This indicates that the value obtained was not clinically valid and should be
repeated.

I would like to obtain a plasma equivalent on my FT,AFTT and there is

no indication for one?
The 8000 is not in the PT or AP?T mode, it must indicate the name of the test
on the top of the CI-eenfor the program to give the equivalent plasma value.

I want to obtain an average between two values on my 8000, but no

average window appears on my screen.
The 8000 will provide an average between two test values of the same test if
they are initiated within 30 seconds of each orher.

My Model 8000 has entered sleep mode. How do I return to normal

mode?
Sinlply push any button on the Model SO00 except the on/off button next to
the blinking light, and your screen will vetuln to normal. For fu~therquestions
-- about the sleep mode see your Owner's Manual.

Hod do I know which well is active on the screen?

The active well is the one with the white background, a solid blue background
indicates an inactive well.
Suppose I am using well one, and I want to use well two. How can I
switch back and forth between them?
Just push the start button next to the well you wish use, and that well will
become active.

When I turn on my iMode18000, how do I get to the patient editing and

setup mode?
The Model 8000 automatically loads to the test screen, therefore you must first
depress the MORE.. key two times, followed by the QUIT key to access the
startup screen menu.

How should I run my fibrinogen tests, diluted or undiluted?

To obtain a fibrinogen level for what you be!ieve to be a norma! patient donor,
you must run the 8000 in the DILUTED mode. If you suspect a patient's
fibrinogen level to be low (Ex. following extensive surgery), you should run the
test in the UNDILUTED mode.

Where can I obtain the product performance W for the fibrinogen test in
my SOOO?
You can obtain your fibrinogen product ID number from the ID label on the
fibrinogen test tube box. If you do not have a fibrinogen ID label on your box,
you can obtain the ID number by calling ITC technical service at 800-631-5945

My 8800 1 ) snot dispky iits norma! s m up screen when I t..med it oc, or

is not operating normally?
Restalt your HEMOCHRON 8000 by turning the power off and back on. If the
problem persists, call ITC Technical Service at (800) 631-5945.

How do I restart an ACT test after the test has started?

The Model 8000 requires 15 seconds of continuous operation as indicated by the
green detector light. After you have reached this point you can pull out the test
tube and restart the test.

I have read the Ownen Manual and I cannot fmd an answer to my ques-
tion, who can I call?
You can call ITC Technical Service at (800) 631-5945,
Mon. - Fri. 8:30 -530 E.S.T.
Five Year Limited Warranty

nternational Technidyne This warranty is granted to the orig-

Corpoi-ation (ITC) wanants the inal purchases for five years from the
HEMOCHRON'" Model 8000, date of manufacture, LCD and battery
when purchased new, to be free excepted. The LCD is covered under
from defects in material and work- this warranty for a period of three
manship and will repair or replace at years and the battery is covered under
ITC's option any HEMOCHRON" this warranty for a period of one year.
Model 8000 instrument which, under
proper conditions of use, exhibits In no way shall ITC be liable for
such defects. Under terms of this special, indirect, incidental, or conse-
warranty, the product must be quential damages, the original user's
returned, properly packaged, trans- remedies being limited to repair or
portation prepaid with copy of proof replacement at the manufacturer's
of purchase to the following location: option.

ITC Unauthorized modification of the

23 Nevsky Street HEMOCHRON" Model 8000 circuit
Edison, NJ 08820 US.A boards or internal componentry will
void this warranty.
 4
23 Nevsky Street Edison, NJ 08820 (800) 631-5945 (908) 548-5700
FAX (908) 632-9299 Customer Senice: (800) 445-0662

P8000: 2 Rev. 5:94 USA