Actalyke® XL

Activated Clotting Time Test System

Operator’s Manual
Catalog Number 5770, 110-220 VAC, 50-60 Hz
 Actalyke® XL
Activated Clotting Time Test System

Operator’s Manual
 WARNING!
DO NOT ATTEMPT TO MOVE, INSTALL, OR
OPERATE THIS INSTRUMENT BEFORE READING
AND UNDERSTANDING THE CONTENTS OF THIS
MANUAL, PARTICULARLY THE PRECAUTIONS,
LIMITATIONS AND HAZARDS IN SECTIONS
THREE AND FOUR.

Actalyke XL Program License Agreement

This copy of the Actalyke XL program is sold on the condition that the purchaser agrees to the
terms of this license agreement.
1. THE COMPUTER PROGRAM AND THE ENCLOSED INSTRUCTIONAL MATERIALS
ARE SOLD “AS IS”, WITHOUT ANY WARRANTY OF ANY KIND, EXPRESSED OR IMPLIED,
INCLUDING BUT NOT LIMITED TO: ANY WARRANTY OF PERFORMANCE, MERCHANT-
ABILITY, OR FITNESS FOR A PARTICULAR PURPOSE. PURCHASER ASSUMES ALL
RISKS AS TO THE PERFORMANCE AND RESULTS OF THE PROGRAM. IN NO EVENT
WILL HELENA OR, ITS SUPPLIERS BE LIABLE FOR ANY INCIDENTAL, CONSEQUENTIAL
OR OTHER DAMAGES, INCLUDING BUT NOT LIMITED TO ANY DAMAGES ARISING
FROM USE OR MISUSE OF THE PROGRAM.
2. This computer program is for the use of purchaser only, and only on the computer system
specified. No part of the program may be reproduced, nor may any part of the program be
utilized in or transferred to any information storage and retrieval system of electronic or
mechanical medium without prior written permission of Helena. Purchaser may make up to
two back-up copies of the program for Purchaser’s personal use only, and should forward any
questions concerning reproduction or transfer of the program, and requests for permission to
do so, to Helena Laboratories, P.O. Box 752, Beaumont, TX 77704-0752. Any noncompliance
with this paragraph will result in termination of this license, and may also result in legal liability
under U.S. copyright laws.
3. Use of this program constitutes acceptance of the terms and conditions of this agreement.

©March, 2019
Helena Laboratories
Helena Laboratories 1530 Lindbergh Dr. P.O. Box 752
Beaumont, Texas 77704
Telephone (409) 842-3714
ACTALYKE XL Table of Contents

List of Sections
Section 1 - Instrument Use and Function............................................................................ 1-1
Figure 1-1. ACTALYKE XL ................................................................................................... 1-2
Section 2 - Principles of Operation ...................................................................................... 2-1
Figure 2-1. Block Diagram ................................................................................................... 2-2
Section 3 - Precautions and Limitations ............................................................................. 3-1
Section 4 - Hazards ............................................................................................................... 4-1
Section 5 - Installation Instruction ....................................................................................... 5-1
5.1. Unpacking and Inspection ............................................................................................ 5-1
5.2. Installation .................................................................................................................... 5-1
5.3. Verification of Functionality ........................................................................................... 5-2
Section 6 - Setup ................................................................................................................... 6-1
6.1. Interface Parameters .................................................................................................... 6-1
6.1.1. Keypad ................................................................................................................... 6-1
6.1.2. Time and Date........................................................................................................ 6-2
6.1.2.1. Date Format..................................................................................................... 6-2
6.1.2.2. Date ................................................................................................................. 6-2
6.1.2.3. Time................................................................................................................. 6-2
6.1.3. Sound ..................................................................................................................... 6-3
6.1.4. Backlight................................................................................................................. 6-3
6.1.5. Printer .................................................................................................................... 6-3
6.1.5.1. Contrast ........................................................................................................... 6-4
6.1.5.2. Header/Footer ................................................................................................. 6-4
6.1.6. Export ..................................................................................................................... 6-5
6.1.6.1. Export Parameters ........................................................................................... 6-5
6.1.7. Spreadsheet ........................................................................................................... 6-5
6.1.7.1. Spreadsheet Parameters ................................................................................. 6-6
6.1.8. System Timers ....................................................................................................... 6-6
6.1.8.1. System Shutdown ............................................................................................ 6-6
6.1.8.2. Operator ID Entry ............................................................................................ 6-7
6.2. General Parameters ..................................................................................................... 6-7
6.2.1. Operator ID/Passwords .......................................................................................... 6-7
6.2.1.1. Enter/Edit Operator ID/ Passwords .................................................................. 6-8
6.2.1.2. Delete Operator ID/ Passwords ....................................................................... 6-8
6.2.1.3. Archive and Retrieve Operator IDs .................................................................. 6-9
6.2.1.4. Initial Operator ID ............................................................................................ 6-9
6.2.2. Patient .................................................................................................................. 6-10
6.2.3. Test ...................................................................................................................... 6-11
6.2.4. QC (Bio) ............................................................................................................... 6-12
6.2.4.1. QC(bio) Levels Which Must Pass .................................................................. 6-12
6.2.4.2. Set QC(bio) Schedule .................................................................................... 6-12
6.2.4.3. C-ACT, K-ACT, G-ACT, and MAX-ACT ......................................................... 6-13
6.2.5. ECT ...................................................................................................................... 6-14
6.2.5.1. ECT Levels Which Must Pass ....................................................................... 6-14
-i-
ACTALYKE XL Table of Contents

6.2.5.2. Set ECT Schedule ......................................................................................... 6-14

6.2.6. Auto Output .......................................................................................................... 6-15
6.3. Paper Feed ................................................................................................................. 6-16
6.4. Archive........................................................................................................................ 6-16
6.4.1. Save Parameters ................................................................................................. 6-16
6.4.2. Restore Parameters ............................................................................................. 6-16
6.4.3. Print Setup Parameters ........................................................................................ 6-16
6.4.4. Save Operator IDs ............................................................................................... 6-20
6.4.5. Restore Operator IDs ........................................................................................... 6-20
6.4.6. Print Operator ID List ........................................................................................... 6-20
6.5. Maintenance ............................................................................................................... 6-20
Section 7 - Operating Instructions ....................................................................................... 7-1
7.1. Instructions for Clotting Time Tests .............................................................................. 7-1
7.1.1. Run Test................................................................................................................. 7-1
7.1.1.1. Patient ID/Patient Demographics..................................................................... 7-2
7.1.1.1.1. Well Number ............................................................................................. 7-3
7.1.1.1.2. Patient ID & Test ....................................................................................... 7-3
7.1.1.1.3. Sex ............................................................................................................ 7-4
7.1.1.1.4. Height........................................................................................................ 7-5
7.1.1.1.5. Weight ....................................................................................................... 7-5
7.1.1.1.6. Clear ACT Points ...................................................................................... 7-6
7.1.1.1.7. Heparin Dosage Documentation ............................................................... 7-6
7.1.1.2. Test.................................................................................................................. 7-7
7.1.2. View Chart.............................................................................................................. 7-7
7.1.3. Change Operator ................................................................................................... 7-8
7.2. To Abort Operation ....................................................................................................... 7-8
7.3. Results.......................................................................................................................... 7-8
7.4. Battery .......................................................................................................................... 7-8
7.4.1. Battery Charge ....................................................................................................... 7-9
7.4.2. Battery Conservation .............................................................................................. 7-9
7.4.3. Battery Usage ........................................................................................................ 7-9
7.5. Operator ID ................................................................................................................... 7-9
7.6. Software Installation ..................................................................................................... 7-9
Section 8 - Test Functions and Quality Control.................................................................. 8-1
8.1. QC ................................................................................................................................ 8-1
8.1.1. Run ECT Self Check (Clotting Time Check)........................................................... 8-1
8.1.2. Run Biological QC Test (QC of Individual Coagulation Assays)............................. 8-2
8.1.3. View/Output View Chart (Levey-Jennings Chart) ................................................... 8-3
8.1.4. Delete Complete QC Test Data.............................................................................. 8-3
8.1.5. Delete Single QC Clot Point ................................................................................... 8-3
8.1.6. Temperature QC (Test Well Temperature Check) ................................................. 8-4
Figure 8-1. Run Test (QC mode) Screen............................................................................. 8-5
Figure 8-2. QC Options Screen ........................................................................................... 8-5
Figure 8-3. QC Biological Screen ........................................................................................ 8-5
Figure 8-4. Levey-Jennings Chart Screen .......................................................................... 8-5

-ii-
ACTALYKE XL Table of Contents

Figure 8-5. Levey-Jennings Chart Printout ........................................................................ 8-6

Figure 8-6. QC Point Deletion Screen ................................................................................. 8-6
Section 9 - Performance Specifications .............................................................................. 9-1
9.1. Instrument Performance Specifications ........................................................................ 9-1
9.2. System Performance Characteristics............................................................................ 9-1
9.2.1. MAX-ACT ............................................................................................................... 9-1
9.2.2. C-ACT, K-ACT and G-ACT .................................................................................... 9-2
Section 10 - Maintenance, Troubleshooting, Warranty .................................................... 10-1
10.1. Maintenance ............................................................................................................. 10-1
10.1.1. Instrument Cleaning ........................................................................................... 10-1
10.1.2. Clotting Time Check ........................................................................................... 10-1
10.1.3. Test Well Temperature Check............................................................................ 10-2
10.1.4. Test Well Cleaning ............................................................................................. 10-2
10.1.5. Touch Panel Calibration ..................................................................................... 10-2
10.1.6. Drain Battery ...................................................................................................... 10-2
10.1.7. Printer Paper Replacement ................................................................................ 10-3
10.1.8. Fuse Replacement ............................................................................................. 10-3
10.1.9. Mag Sensor Calibration ...................................................................................... 10-4
10.1.10. Battery Replacement ........................................................................................ 10-4
Figure 10-1. Battery Replacement..................................................................................... 10-6
Figure 10-2. Preventive Maintenance schedule Checklist .............................................. 10-7
10.2. Troubleshooting ........................................................................................................ 10-8
10.3. Warranty ................................................................................................................. 10-13
10.4. Regulatory Information ........................................................................................... 10-13
Section 11 - Symbology ...................................................................................................... 11-1
Section 12 - Communication Specifications ..................................................................... 12-1
Section 13 - Menu Flowchart .............................................................................................. 13-1
Section 14 - Index ................................................................................................................ 14-1

List of Figures
Figure 1-1. ACTALYKE XL ................................................................................................... 1-2
Figure 2-1. Block Diagram ................................................................................................... 2-2
Figure 5-1. Actalyke XL, Front View..................................................................................... 5-3
Figure 5-3. Actalyke XL, Top View ....................................................................................... 5-4
Figure 5-4. Actalyke XL, Top View with Paper .................................................................... 5-4
Figure 5-5. Actalyke XL, Left Side ........................................................................................ 5-5
Figure 5-6. Actalyke XL, Left Side ........................................................................................ 5-5

-iii-
ACTALYKE XL Table of Contents

Figure 5-7. Actalyke XL, Right Side ..................................................................................... 5-6

Figure 6-1. Enter Operator ID Screen* .............................................................................. 6-21
Figure 6-2. Run Test Screen .............................................................................................. 6-21
Figure 6-3. Setup Screen ................................................................................................... 6-21
Figure 6-4. Setup Interface Parameters Screen ............................................................... 6-21
Figure 6-5. Select Preferred Keypad Screen .................................................................... 6-22
Figure 6-6. Setup Time & Date Screen.............................................................................. 6-22
Figure 6-7. Set Date Format Screen .................................................................................. 6-22
Figure 6-8. Set Date Screen* ............................................................................................. 6-22
Figure 6-9. Set Time Screen* ............................................................................................. 6-23
Figure 6-10. Setup Sound Screen ..................................................................................... 6-23
Figure 6-11. Set Backlight Screen..................................................................................... 6-23
Figure 6-12. Setup Printer Screen ..................................................................................... 6-23
Figure 6-13. Printer Contrast Adjustment Screen ........................................................... 6-24
Figure 6-14. Setup Export Parameters Screen ................................................................ 6-24
Figure 6-15. Set Spreadsheet Parameters Screen ........................................................... 6-24
Figure 6-16. Select Timer Screen ...................................................................................... 6-24
Figure 6-17. Select Shutdown Time-out Screen .............................................................. 6-25
Figure 6-18. Select Operator ID Time-out Screen*........................................................... 6-25
Figure 6-19. General Parameters Screen ......................................................................... 6-25
Figure 6-20. Enter Operator ID List Screen* ..................................................................... 6-25
Figure 6-21. Passwords Screen* ....................................................................................... 6-26
Figure 6-22. Select Editable Demographics Screen ........................................................ 6-26
Figure 6-23. Setup Test Parameters Screen .................................................................... 6-26
Figure 6-24. ACT Timing Sequence Screen* .................................................................... 6-26
Figure 6-25. ACT Test Range Limits Screen* ................................................................... 6-27
Figure 6-26. Setup QC(bio) Screen ................................................................................... 6-27
Figure 6-27. QC(bio) Schedule Screen* ............................................................................ 6-27
Figure 6-28. QC Lot Numbers Screen ............................................................................... 6-27
Figure 6-29. Enter Lot Number Screen*............................................................................ 6-28
-iv-
ACTALYKE XL Table of Contents

Figure 6-30. QC Mean and Range Screen ........................................................................ 6-28

Figure 6-31. Enter Lower/Upper Limit Screen* ................................................................ 6-28
Figure 6-32. Setup ECT screen ......................................................................................... 6-28
Figure 6-33. ECT Schedule screen* .................................................................................. 6-29
Figure 6-34. Setup Automatic Output Screen .................................................................. 6-29
Figure 6-35. Save/Restore/Print Screen ........................................................................... 6-29
Figure 7-1. Enter Operator ID Screen* .............................................................................. 7-11
Figure 7-2. Run Test Screen .............................................................................................. 7-11
Figure 7-3. Patient Demographics Screen ....................................................................... 7-11
Figure 7-4. Patient ID Entry/Selection Screen* ................................................................ 7-11
Figure 7-5. Select Patient Height Screen.......................................................................... 7-12
Figure 7-6. Select Patient Weight Screen ......................................................................... 7-12
Figure 7-7. Heparin Dosage Documentation Screen*...................................................... 7-12
Figure 7-8. Results ACT Chart Screen.............................................................................. 7-12
Figure 7-9. Results ACT Chart Printout ............................................................................ 7-13
Figure 8-1. Run Test (QC mode) Screen............................................................................. 8-5
Figure 8-2. QC Options Screen ........................................................................................... 8-5
Figure 8-3. QC Biological Screen ........................................................................................ 8-5
Figure 8-4. Levey-Jennings Chart Screen .......................................................................... 8-5
Figure 8-5. Levey-Jennings Chart Printout ........................................................................ 8-6
Figure 8-6. QC Point Deletion Screen ................................................................................. 8-6
Figure 10-1. Battery Replacement..................................................................................... 10-6
Figure 10-2. Preventive Maintenance schedule Checklist .............................................. 10-7

List of Tables
Table 5-1. Inventory.............................................................................................................. 5-1
Table 5-2. Additional Materials ............................................................................................ 5-1
Table 10-1. Maintenance Schedule ................................................................................... 10-1
Table 10-2. Troubleshooting ............................................................................................. 10-8
Table 10-3. Prompts and Error Messages ...................................................................... 10-11

-v-
ACTALYKE XL Table of Contents

-vi-
ACTALYKE XL ONE - Instrument Use and Function

Section 1 - Instrument Use and Function precise test results. Each tube contains a
clotting activator and magnet.
Note: The floppy disk drive from the Actalyke
XL has been removed. Any functions Refer to the procedure supplied with the
associated with it are no longer available. tubes for information on the following areas:
Actalyke® XL Activated Clotting Time Test Summary
System (Figure 1-1) is used to perform the Principle
Activated Clotting Time (ACT) test, a whole Reagents
blood coagulation assay used at the patient Instruments
site to monitor heparin therapy. The system Specimen Collection and Handling
is portable and designed to perform a range Procedure
of whole blood coagulation tests at the Performance Characteristics
point-of-care, using Activated Clotting Time Reference Ranges
(ACT) measurement techniques. Bibliography
ACTALYKE XL is intended for in-vitro
diagnostic use only, and is for use in a
laboratory or point-of-care environment.
The ACTALYKE XL System can be used
whenever and wherever ACT testing is
desired, such as:
•Hemostasis Laboratory
•Cardiopulmonary Bypass Surgery
•Hemodialysis
•Extracorporeal Membrane Oxygenation
(ECMO)
•Percutaneous Transluminal Coronary
Angioplasty
•Cardiac Catherization
•Critical Care
The ACTALYKE XL System provides an
alternative to other Activated Clotting Time
(ACT) methodologies. The instrument
monitors moderate to high levels of heparin
during various surgical and medical proce-
dures, with good sensitivity, linearity and
precision.
The ACTALYKE XL System is a dual-
detector analyzer with a printer. The
instrument is modular in construction for
enhanced durability, portability, and flexible
storage options.
The ACTALYKE XL System has program-
mable test and output parameters.
Actalyke Test Tubes are manufactured to
the highest specification for accurate and

1-1
ACTALYKE XL ONE - Instrument Use and Function

Figure 1-1. ACTALYKE XL

1-2
ACTALYKE XL TWO - Principles of Operation

Section 2 - Principles of Operation

Note: The floppy disk from the Actalyke XL
has been removed. Any functions associated
with it are no longer available.
Operation is controlled by a microprocessor,
its program and memory, and a touch screen
liquid-crystal display (LCD) controlling
selections.
The computer runs a self-test at power On to
detect error conditions or potential problems.
Setup access can be controlled using
operator identification numbers, passwords,
and the three levels of security access.
The test wells of the instrument incorporate a
test tube identification sensor and a highly
sensitive clot detection mechanism. The test
tube identification sensor reads and enters
the test type for the ACT tube(s) in use. The
clot detection mechanism operates by using
a magnet contained in a test tube and a set
of two solid-state, magnetic detectors located
in the test well.
One magnetic detector is located at 0° and
the other at 90°, with respect to the test tube.
When a test tube is inserted into a test well,
the detector at 0° senses the presence of the
magnet as the tube slowly rotates.
As a clot forms, the fibrin strands cause the
magnet in the tube to rotate. The detector at
90° senses the motion of the tube magnet
and a clotting end-point is determined. This
two-point detection sensing system minimiz-
es the possibility of a missed end-point.
The test well holds the test tube. When Start
is pressed for the test well in use, the
microcomputer turns on the motor, which
rotates the test tube. The heater remains at
a constant 37°C + 0.5, and is monitored by
the internal electronics. When the clotting
end-point is detected, the instrument notifies
the operator that the procedure is complete
by activating an audible indicator, displaying
the results and/or printing the results.

2-1
ACTALYKE XL TWO - Principles of Operation

External Devices

LIS
Keyboard Barcode
Wand

Floppy Drive Computer LCD Display

Touch Screen Motor

Temperature Printer
Sensors

0° Hall Sensors Controller Alarm

90° Hall Sensors Heater Driver

Test Tube Heaters

Barcode Readers

PCB Power Supply

Battery Power Supply

Figure 2-1. Block Diagram

2-2
ACTALYKE XL THREE - Precautions and Limitations

Section 3 - Precautions and Limitations Thermometer, or an item this manual

indicates as appropriate.
Note: The floppy disk from the Actalyke XL
has been removed. Any functions associated 3.12. If resistance is encountered when
with it are no longer available. inserting a tube into the test well, or there is
resistance when the tube is rotating, do not
3.1. The entire Operator’s Manual should be
force the test tube into the test well. Careful-
read and understood before attempting
ly remove the test tube and check the well.
instrument operation.
Remove any obstruction before using the
3.2. Refer to the procedures supplied with instrument further.
the activator kits for proper testing protocols.
Warning: Do not leave anything in the test
3.3. Provide adequate room at the sides and wells when instrument is not in use. This
back of the instrument for good air circula- can affect functionality of the instrument
tion.
3.13. All guidelines pertaining to the handling
3.4. Do not expose the instrument to drafts or of fresh whole human blood should be
to direct sunlight. Do not operate at tem- adhered to when handling the test tubes and
peratures above 30°C (86°F), or below 15°C operating the instrument.
(59°F), or allow prolonged exposure to high
3.14. Used test tubes should be considered
humidity.
contaminated and may represent a biohaz-
3.5. Do not place the instrument near a ard. These should be handled and disposed
strong source of electromagnetic interfer- in accordance with the user’s policy regard-
ence, such as a centrifuge, X-ray machine, ing contaminated and biohazardous
etc. materials.
3.6. WARNING: Do not use the instrument 3.15. Should instruments be contaminated by
in any area, which has, or is thought to have, blood or blood derivatives, clean the area
been exposed to explosive gases. contaminated with a commercial virucidal
3.7. For AC outlet specification, see the and germicidal agent. Observe where
serial number plate located on the back of specimens are used inside the instrument,
the instrument. and confine cleaning to that area. Wipe up
the agent residue, as these materials may
3.8. For emergency shut down, unplug the contain alcohol, which is corrosive to metal
instrument power cord. To unplug the surfaces.
instrument from the power supply, always
disconnect from the AC outlet. Firmly grasp No harsh cleansers, acids, or bases should
the plug and pull. Do not remove the plug by be used or spilled on inner or outer surfaces.
pulling the line cord. With the power cord Do not immerse the unit. ALWAYS TURN
disconnected, turn the power switch Off. THE POWER SWITCH OFF AND UNPLUG
THE MAIN POWER CORD BEFORE
3.9. No operation or maintenance should be CLEANING.
undertaken by the operator, which requires
the removal of the instrument's covers unless 3.16. The instrument's systems are designed
specified in this manual. for use only with ACT tubes. Do not use the
instrument with test tubes that are past the
3.10. Do not use excessive force when expiration date marked on the tube label or
making selections on the instrument display. on the corresponding test tube box.
3.11. Do not attempt to insert any material 3.17. With a properly maintained and
into the instrument other than an ACT tube, operated instrument, the prime external
an Electronic Clotting Tube, the temperature factor affecting the accuracy and precision of
probe holder supplied with the Actalyke the test is the quality of the blood specimen
3-1
ACTALYKE XL THREE - Precautions and Limitations

used. Specimen contamination, inappropri- information on minimizing biohazard risk, see

ate operating technique and excessive to section 3.15.
temperature variations will also affect the test 3.24. Storage and transport environmental
results. requirements:
3.18. The ACT test results may be affected Operating Temperature range: 15° to 30° C
by hemodilution, hypothermia, pharmacolog- Storage and shipping temperatures: -20° to 45° C
ic compounds and various coagulopathies. 3.25. The Helena Agent shall provide a
Test results should be interpreted with power cord or adapter of the proper configu-
respect to the patient’s condition and the ration for the country in which the instrument
clinical circumstances, such as anticoagula- is to be installed. The power cord or adapter
tion therapy. will comply with IEC 60227, IEC 60245, or be
Test results, which do not agree with certified as rated for the power specified in
expected values or test results that are section 9 of this manual.
inconsistent, should be repeated. Any test 3.26. Use standard precautions when
result of ≥1500 seconds has no clinical handling disks. Refer to the disk jackets or
value, and the test should be repeated inserts for appropriate precautions.
immediately. These samples should be
further evaluated using other diagnostic 3.27. The disks should be removed when not
methods, if indicated. See section 7.3. in use, to prevent damage.
3.19. If further validation of the system is 3.28. Keep disks away from magnets
required, several tests should be run using (including ACT tubes and ECT devices), as
Actalyke Quality Control Materials or other stored information may be lost. Do not place
commercial coagulation controls. disks near a magnetic source or a strong
source of electromagnetic interference.
3.20. If a printout is to be part of a permanent
record, photocopy the printout and save the 3.29. Formatting a disk, which already
photocopy. contains data, will erase the original data.
3.21. Instructions for the "responsible body*"
(*Under IEC 61010-2-101:2002 -- the
person(s) responsible for the use and
maintenance of equipment and for ensuring
that operators are adequately trained for
eliminating and reducing hazards involved in
removal from use, transportation, or dispos-
al.)
3.22. Action(s) to be taken in case of
malfunction: See section 3.8 and 10.2.
3.23. Requirements for handling biohazards:
Due to potential biohazard risk from human
blood, guidelines pertaining to Universal
Precautions shall be adhered to when
handling the samples and operating this
instrument. This includes the use of protec-
tive gloves and any other protective
equipment as warranted for safe handling
and disposal of test tubes and use, transpor-
tation and disposal of this device. For

3-2
ACTALYKE XL FOUR - Hazards

Section 4 - Hazards 4.12. WARNING: External equipment

(barcode reader, keyboard, computer) that is
Note: The floppy disk from the Actalyke XL
connected to the instrument must have no
has been removed. Any functions associated
live parts that are accessible.
with it are no longer available.
4.1. If the instrument is used in a manner
not specified by this manual, protection
provided by equipment design may be
impaired.
4.2. This unit contains high voltages, which
can be extremely dangerous. ALWAYS
TURN OFF THE POWER, DISCONNECT
THE MAIN POWER CORD, AND USE
EXTREME CARE when attempting to clean
or repair.
4.3. When operating the instrument on AC
power, do not attempt to do so without
plugging the power cord into an easily
accessible, grounded AC wall outlet of the
proper voltage and frequency. This infor-
mation is contained on the serial number
plate located on the back of the instrument.
4.4. Running this instrument in the US on
220 V AC is prohibited. This instrument
requires a zero reference on AC input, so
cannot be run on 220V AC in the US. Fire
protection is not assured if this is not
followed.
4.5. Do not lubricate the instrument.
4.6. Use only the test tubes specified by the
Helena Laboratories procedure in use.
Damage to the instrument may result from
introducing some types of solutions into the
instrument.
4.7. Follow safe handling and disposal
procedures for test tubes used with this
device.
4.8. Keep flammable liquids and flammable
vapors away from the instrument at all times.
4.9. Particular symbols may be used to
provide information to the user. Refer to
section 11.
4.10. Use only specified printer paper.
4.11. WARNING: Do not use non-
rechargeable batteries.
4-1
ACTALYKE XL FIVE - Installation Instructions

Section 5 - Installation Instruction 5757 Actalyke Thermometer

5758 Barcode Reader and Cable
WARNING: Read section three, Precau-
5759 Actalyke XL Battery Pack
tions and Limitations, and section four,
C-ACT Celite Tube
Hazards, before attempting installation or
K-ACT Kaolin Tubes
device operation.
G-ACT Glass Bead Tubes
Note: The floppy disk from the Actalyke XL MAX-ACT MAX-ACT Tubes
has been removed. Any functions associated AQC-H Actalyke Whole Blood QC
with it are no longer available. (for C-ACT, K-ACT, & MAX-ACT)
5.1. Unpacking and Inspection AQC-L Actalyke Whole Blood QC
(for G-ACT)
1. Check all shipping containers for signs of
damage. If damage is found, immediately 5.2. Installation
notify the shipping carrier. This instrument is an installation Category II
2. Carefully, unpack instrument and acces- device under EN 61010-1, for use in a
sories from the shipping cartons. The laboratory or similar environment.
packing material should be removed un- 1. Select an environment free of drafts,
damaged, if possible, should repacking be direct sunlight, excessive humidity and
necessary. dust, and temperature fluctuations. Ambi-
3. Remove plastic wrappings from the ent temperature should be between 15°C
instrument and accessories. If scissors or to 30°C (59°F to 86°F).
a knife is used to cut the plastic or binding 2. Place the instrument on a flat, rigid,
tape, take care not to scratch the instru- horizontal surface, preferably located near
ment. the patient. Using the carrying han-
4. Inspect the instrument for any obvious dle/stand, prop up the instrument (Error!
signs of damage. If damage is found, notify Reference source not found.).
the shipping carrier and Helena Laborato- 3. Confirm the instrument is Off (). The one
ries. connector, accessible from the rear (), is an
5. Inventory all items. If any parts are IEC connector. Plug the power cord into
missing, recheck the packing materials this connector. Secure the power cord in
before notifying Helena Laboratories. the clip located on the rear of the instru-
ment (). Plug the other end into a
Table 5-1. Inventory grounded wall outlet of the proper voltage
and frequency. Supply voltage should not
ACTALYKE XL Instrument fluctuate more than +/- 10% of the nominal
Power Cord rating. Because the power cord is the
Operator’s Manual mains disconnect device, the wall outlet
Operator's Manual on CD used should be easily accessible. These
Roll of Actalyke Thermal Printer Paper specifications can be found on the serial
Actalyke XL Installation Report Form number plate located on the back of the
Actalyke XL Program Disk instrument.
Table 5-2. Additional Materials The wall outlet should not be on the same
circuit as any large load device such as a
Required Materials refrigerator, compressor, centrifuge, etc.
XL-ECT Actalyke Electronic Clotting Tube The instrument circuitry contains filters to
A-PPR Actalyke Thermal Printer Paper reduce the effect of line voltage fluctua-
tions; however, they should still be avoided.
Available Materials
5-1
ACTALYKE XL FIVE - Installation Instructions

An additional caution for US users: This 2. Perform the Test Well Temperature
instrument requires a zero reference on AC Check for each test well. Refer to sec-
input, so it cannot be run on 220V AC in the tion 8.1.6 for instructions. Make the
US. Fire protection is not assured if this is necessary notations on the installation
not followed. report.
4. To connect the instrument and the 3. Perform the Clotting Time Check for
optional barcode reader or an external each test well. Refer to section 8.1.1 for
keyboard and/ or to connect to an external instructions. Make the necessary notations
computer (LIS): Confirm the instrument is on the installation report.
Off (). On the left side of the instrument 4. Perform a QC of Individual Coagula-
(Error! Reference source not found. or tion Assay for each test well. Refer to
Error! Reference source not found.), section 8.1.2 and to the procedure supplied
remove the appropriate panel to access the with the Actalyke tubes for instructions.
desired connection(s). Plug the device Make the necessary notations on the
and/or LIS into the instrument. installation report.
5. Turn the instrument On (). When the Should any problems occur during installa-
Enter Operator ID screen (Figure 6-1) tion, refer to section 10.2, or call Helena
displays, select OK. When the Run Test Laboratories.
screen (Figure 6-2) displays, confirm the
screen reads Charging in the lower left
corner. The instrument’s battery may need
charging for up to 18 hours to be at full
capacity. See section 7.4 for more infor-
mation on the battery.
6. Load the roll of printer paper ( and Error!
Reference source not found.); see sec-
tion 10.1.7 for instructions.
7. Install the F2 fuse (the fuse and fuse
holder are secured to the front of the in-
strument during shipping). To install the
fuse, place the fuse in the fuse holder and
then place the holder in the F2 fuse posi-
tion located on the left rear of the
instrument. Using a small flathead screw-
driver, push the holder in and rotate
clockwise until it is seated.
5.3. Verification of Functionality
Read the entire Operator’s Manual. With the
instrument turned On, complete the applica-
ble section of the Actalyke XL Installation
Report as the following steps are performed:
1. Verify the Operating Environment
Temperature falls within the specified
range. Refer to section 9.1 for specifica-
tions. Make the necessary notations on the
installation report.

5-2
 ACTALYKE XL FIVE - Installation Instructions

Display

Test Wells

Figure 5-1. Actalyke XL, Front View

Fuses

Power Cord
Clip

IEC / Power Cord

Connection

Figure 5-2. Actalyke XL, Back View

5-3
ACTALYKE XL FIVE - Installation Instructions

Serrated Plate
Adjustment
Screws

Adjustment
Screws

Figure 5-3. Actalyke XL, Top View

Paper Out

Paper Retainer

Paper In

Figure 5-4. Actalyke XL, Top View with Paper

5-4
 ACTALYKE XL FIVE - Installation Instructions

The instrument’s left side will resemble either Figure 5-5 or 5-6

External Computer (LIS) Serial Connection

Figure 5-5. Actalyke XL, Left Side

Keyboard or Barcode Reader Connection

USB Ports

External Computer (LIS) Serial Connection

Figure 5-6. Actalyke XL, Left Side

5-5
ACTALYKE XL FIVE - Installation Instructions

Figure 5-7. Actalyke XL, Right Side

5-6
ACTALYKE XL SIX - Setup

Section 6 - Setup (1) Enter an appropriate Supervisor

Full Rights or Setup Access Operator ID
Note: The floppy disk from the Actalyke XL
and Password per the instructions in step
has been removed. Any functions associated
3.b.
with it are no longer available.
(2) Or, to access the instrument with
1. An external keyboard and barcode
Operation Only access, either enter any
reader may be used for portions of the
number as the Operator ID and press OK,
instrument setup. The device should be
or simply press OK. With no Operation
connected prior to powering up the instru-
Only IDs setup, accessing the instrument in
ment (see Error! Reference source not
this manner allows the user to have Opera-
found. and Error! Reference source not
tion Only access.
found. for connection location).
4. Once OK is selected, the Run Test
2. Turn the power switch On ().
screen (Figure 6-2) displays.
3. The first displayed screen is the Enter
6.1. Interface Parameters
Operator ID screen (Figure 6-1).
All of the parameters available may be setup
a. If the instrument is being used for the
through the Interface Parameters menu
first time, either enter an identification
without returning to the Run Test screen after
number in the Operator ID field, using the
each selection; however, selections are not
keypad, Bksp (backspace), and Clear keys,
saved until the instrument is returned to the
or a barcode reader, and select OK, or
Run Test screen.
simply select OK.
To access the Interface Parameters menu,
b. If the instrument has been setup to
from the Run Test screen, select Setup.
use operator identification number / pass-
From the Setup screen, select Interface
word / security access level combinations
Parameters.
(section 6.2.1), enter an appropriate opera-
tor ID number in the Operator ID field using 6.1.1. Keypad
the keypad, Bksp (backspace), and Clear A numeric keypad is displayed on several
keys or a barcode reader. Then enter the screens to enter data. The keypad displays
corresponding password in the Password in one of two user-selected formats: Calcula-
field using the keypad, Bksp (backspace), tor or Phone. The instrument’s default
and Clear keys. Use the  up and the  keypad setting is the Phone format. To alter
down keys to move between the two fields. the format, use the following steps beginning
For information on the type of access al- from the Run Test screen (Figure 6-2):
lowed with each of the three access levels,
see section 6.2.1. With the operator ID and 1. Select Setup (Figure 6-2).
password entered, press OK. 2. Select Interface Parameters (Figure 6-3).
(1) If the Allow 2nd Operator for Well 3. Select Keypad (Figure 6-4).
2 feature (section 6.2.3) is in use, the
access level of the operator ID entered 4. From the Select Preferred Keypad
here determines the access level of both screen (Figure 6-5), select either Phone or
operators. Calculator.
c. If the instrument has been setup to 5. Select OK to return to the Setup Inter-
use operator identification number / pass- face Parameters screen (Figure 6-4).
word / security access level combinations 6. To save selections, return to the Run
for Supervisor Full Rights and Setup Access Test screen (Figure 6-2) by selecting OK
operators only (section 6.2.1), either: until the Run Test screen appears.

6-1
ACTALYKE XL SIX - Setup

6.1.2. Time and Date 2. Select Interface Parameters (Figure 6-3).

The instrument allows for the desired date 3. Select Time & Date (Figure 6-4).
format to be selected and the current date 4. Select Date (Figure 6-6).
and time to be set.
5. On the Set Date screen (Figure 6-8), use
6.1.2.1. Date Format the keypad, the < key (to move the cursor
The date can be displayed in several different to the left), and the > key (to move the
formats. To choose a format from the cursor to the right) to enter the current date.
selections, use the following steps beginning The date will appear in the currently select-
from the Run Test screen (Figure 6-2): ed format, except if the MMM dd, yyyy
format is currently in use. In this case, the
1. Select Setup (Figure 6-2).
date will appear on this screen in the
2. Select Interface Parameters (Figure 6-3). mm/dd/yyyy format.
3. Select Time & Date (Figure 6-4). 6. Once the date is entered, select Set
4. Select Date Format (Figure 6-6). Date.

5. The Set Date Format screen (Figure 6-7) 7. Select OK to return to the Setup Time &
contains seven different date format styles. Date screen (Figure 6-6).
The six formats presented in all lower case 8. Select one of the following:
letters will display the date numerically in
a. To change the selected date format,
the order indicated. For example, the
see section 6.1.2.1 step 4.
dd/mm/yy format will appear as 14/12/01.
For the seventh format, MMM dd, yyyy, the b. To enter or edit the current time, see
same date will appear as Dec 14, 2001. section 6.1.2.3 step 4.
Note that date formats using more than six c. To save selections, return to the Run
digits will appear, in some instances, in the Test screen (Figure 6-2) by selecting OK
six-digit format closest to the selected until the Run Test screen appears.
format. For example, MMM dd, yyyy
appears as mm/dd/yy and yyyy/mm/dd as 6.1.2.3. Time
yy/mm/dd. Select the desired format. To set the current time, use the following
6. Select OK to return to the Setup Time & steps beginning from the Run Test screen
Date screen (Figure 6-6). (Figure 6-2):
7. Select one of the following: 1. Select Setup (Figure 6-2).
a. To enter or edit the current date, see 2. Select Interface Parameters (Figure 6-3).
section 6.1.2.2 step 4. 3. Select Time & Date (Figure 6-4).
b. To enter or edit the current time, see 4. Select Time (Figure 6-6).
section 6.1.2.3 step 4.
5. From the Set Time screen (Figure 6-9),
c. To save selections, return to the Run select the 12/24 Hr key to change the
Test screen (Figure 6-2) by selecting OK format of the time from its current setting to
until the Run Test screen appears. either 12 or 24 hours.
6.1.2.2. Date 6. Select the AM/PM key in the 12-hour
To set the current date, use the following format to identify the entered time as am or
steps beginning from the Run Test screen pm. Select the AM/PM key in the 24-hour
(Figure 6-2): format to change the entered time to its 24
hour equivalent.
1. Select Setup (Figure 6-2).

6-2
ACTALYKE XL SIX - Setup

7. Use the keypad, the < key (to move the 6.1.4. Backlight
cursor to the left), and the > key (to move To aid in viewing the screens, the backlight
the cursor to the right) to enter the time. may be altered to affect the screens contrast.
8. Once the New Time is entered as needed, To alter the backlight setting, use the
select Set Time. following steps beginning from the Run Test
screen (Figure 6-2):
9. Select Exit to return to the Setup Time &
Date screen (Figure 6-6). 1. Select Setup (Figure 6-2).
10. Select one of the following: 2. Select Interface Parameters (Figure 6-3).
a. To change the selected date format, 3. Select Backlight (Figure 6-4).
see section 6.1.2.1 step 4. 4. On the Set Backlight screen (Figure
b. To enter or edit the current date, see 6-11), select from Off or 1, for the darkest
section 6.1.2.2 step 4. setting, through Full On or 6, for the bright-
est setting.
c. To save selections, return to the Run
Test screen (Figure 6-2) by selecting OK 5. Select OK to return to the Setup Inter-
until the Run Test screen appears. face Parameters screen (Figure 6-4).
6.1.3. Sound 6. To save selections, return to the Run
Test screen (Figure 6-2) by selecting OK
The instrument can emit sounds for user
until the Run Test screen appears.
notification. To alter the sounds, use the
following steps beginning from the Run Test 6.1.5. Printer
screen (Figure 6-2): The information included on the printouts and
1. Select Setup (Figure 6-2). included with spreadsheet files may be
customized. To set the preferred options,
2. Select Interface Parameters (Figure 6-3).
use the following steps beginning from the
3. Select Sound (Figure 6-4). Run Test screen (Figure 6-2):
4. On the Setup Sound screen (Figure 1. Select Setup (Figure 6-2).
6-10), for each of the three events, Click,
2. Select Interface Parameters (Figure 6-3).
Warning, and Run Done, a sound may be
emitted. A Click is emitted whenever a key 3. Select Printer (Figure 6-4).
is pressed. A Warning is emitted whenever 4. The Setup Printer screen (Figure 6-12)
a selected time period has expired or a test displays four options. Select Yes for each
falls outside of selected parameters. A Run option desired to appear on the printout
Done is emitted whenever a test is com- and in spreadsheet files:
pleted. Select None, 1, 2, 3, 4, or 5 for
each of the three events. Select NONE a. Serial Number - the serial number, of
and no sound is emitted. Or select from 1 the instrument, only prints when set to Yes
through 5 for the desired sound. on this screen and when the results chart
prints, either automatically (section 6.2.6)
5. Select OK to return to the Setup Inter- or manually (section 7.1.2).
face Parameters screen (Figure 6-4).
b. Operator ID - the operator ID of the
6. To save selections, return to the Run operator who ran the test and/or the opera-
Test screen (Figure 6-2) by selecting OK tor currently in use.
until the Run Test screen appears.
c. Date - the date the test (or, when
printing the results chart, the date the first
test) was completed.

6-3
ACTALYKE XL SIX - Setup

d. Time - the time the test (or, when 7. Select OK to return to the Setup Printer
printing the results chart, the time the first screen (Figure 6-12).
test) was completed. 8. Select one of the following:
5. From the Setup Printer screen (Figure a. To alter the information included on
6-12), select from the following: printouts and in spreadsheet files, see
a. To set the contrast of the printouts, section 6.1.5 step 4.
see section 6.1.5.1 step 4. b. To add a header and/or footer to the
b. To add a header and/or footer to printout, see section 6.1.5.2 step 4.
printouts, see section 6.1.5.2 step 4. c. To save selections, return to the Run
c. To save selections, return to the Run Test screen (Figure 6-2) by selecting OK
Test screen (Figure 6-2) by selecting OK until the Run Test screen appears.
until the Run Test screen appears. 6.1.5.2. Header/Footer
6.1.5.1. Contrast The printout may contain a header and/or
The contrast of the paper and text on the footer. To enter a header and/or footer, an
printouts can be altered to aid in reading external keyboard is needed. To connect a
printouts. To alter the contrast, follow these keyboard to the instrument, turn the instru-
steps beginning from the Run Test screen ment Off, plug in the keyboard (see Error!
(Figure 6-2):
Reference source not found. and Error!
1. Select Setup (Figure 6-2). Reference source not found. for connec-
2. Select Interface Parameters (Figure 6-3). tion location), and turn the instrument On.
With the keyboard connected, use the
3. Select Printer (Figure 6-4). following steps beginning from the Run Test
4. On the Setup Printer screen (Figure 6-12), screen (Figure 6-2):
select Contrast. 1. Select Setup (Figure 6-2).
5. The Printer Contrast Adjustment screen 2. Select Interface Parameters (Figure 6-3).
(Figure 6-13) displays.
3. Select Printer (Figure 6-4).
a. Use the , , , and  keys to
adjust the contrast from 0 to 25. Zero is the 4. From the Setup Printer screen (Figure
least contrast and twenty-five is the great- 6-12), select either Header or Footer.
est. The  and  keys change the 5. The screen displays, “Enter report head-
contrast by five. The  and  keys er (footer) using an external keyboard.”
change the contrast by one.
6. Use an external keyboard to enter, edit
b. Each time the contrast setting is or remove the header or footer. The head-
changed the printer prints, “Contrast: xx”, er and footer can contain up to
with xx the current contrast setting. twenty-seven characters.
c. Note that higher contrast settings 7. Select OK to return to the Setup Printer
may cause problems with printouts requir- screen (Figure 6-12).
ing the contrast setting be lowered. These
8. Select one of the following:
problems may appear intermittently be-
cause they are most evident on lines where a. To enter a header or footer, return to
the text is preprogrammed to appear bold- step 4 of this section.
ed. b. To adjust the contrast, see sec-
6. To reenter the contrast set when the tion 6.1.5.1 step 4.
screen was accessed, select Undo.
6-4
ACTALYKE XL SIX - Setup

c. To alter the information included on 4. From the Setup Export Parameters

printouts and in spreadsheet files, see screen (Figure 6-14), select the appropriate
section 6.1.5 step 4. options for Protocol, Data Bits, Parity, Stop
Bits, and Baud Rate. See section 12 for
d. To save selections, return to the Run
additional information.
Test screen (Figure 6-2) by selecting OK
until the Run Test screen appears. 5. To save selections, return to the Run
Test screen (Figure 6-2) by selecting OK
6.1.6. Export
until the Run Test screen appears.
1. The data generated can be exported to
6.1.7. Spreadsheet
an external computer or LIS (see Error!
Reference source not found. and Error! 1. The clot data generated can be saved to
Reference source not found. for connec- a 3½” disk for use with a spreadsheet
tion location). program (see Error! Reference source
not found. for floppy disk drive location).
2. The content of the data exported for
The data can be saved automatically
tests is determined by automatically includ-
(section 6.2.6) and/or manually (section
ed data and selections made in setup.
7.1.2 and 8.1.3).
a. For patient tests, patient ID must be
2. The content of the data saved is deter-
in use for data to be exported (section
mined by automatically included data and
6.2.2).
by selections made in setup:
(1) The minimum data exported is:
a. For patient tests, patient ID must be
the type of test run; the date and time the
in use for data to be saved (section 6.2.2).
test was run; the clotting time results; the
patient identification number; the instru- (1) The minimum data saved is: the
ment's serial number; and the sequential type of test run; the date and time the test
run number. was run; the clotting time results; and the
(2) If
patient identification number (if entered).
in use, the patient de-
mographics (section 6.2.2) and/or the ACT (2) If in use, patient demographics
test range limits (section 6.2.3) are export- (section 6.2.2) and/or the ACT test range
ed. limits (section 6.2.3) are saved.
b. For QC tests, the data exported is: (3) Additionally, if any heparin is ad-
the type of the test run; the level of the test ministered, the last dosage, the time
run; the test well used; the date and time administered, and the total dosage are
the test was run; the clotting time results; saved.
the standard deviation index; the instru- b. For QC tests, the minimum data
ment's serial number; and the sequential saved is: the type of test run; the level of
run number. the test run; the test well used; the date
6.1.6.1. Export Parameters and time the test was run; the clotting time
results; and the standard deviation index.
To setup the instrument to export test data,
use the following steps beginning at the Run c. For both patient and QC data, any of
Test screen (Figure 6-2): the following may also be included, if setup
for use (section 6.1.5): the instrument's
1. Select Setup (Figure 6-2).
serial number; the date and/or time the
2. Select Interface Parameters (Figure 6-3). data is saved; and the operator's ID.
3. Select Export (Figure 6-4).

6-5
ACTALYKE XL SIX - Setup

6.1.7.1. Spreadsheet Parameters b. For QC tests, with all available data

saved, the labels are: Test, Level, Well
An external keyboard may be needed to
No., Run Date, Run Time, Clotting Time
setup the instrument for use with a spread-
(sec), SD, S/N, Operator ID, Date, and
sheet. The device should be connected prior
Time.
to powering up the instrument (see Error!
Reference source not found. and Error! 8. To save selections, return to the Run
Reference source not found. for connec- Test screen (Figure 6-2) by selecting OK
tion location). until the Run Test screen appears.
To setup the instrument, use the spread- 6.1.8. System Timers
sheet manufacturer's recommended The instrument has two timers available for
parameters and the following steps begin- operator use, the System Shutdown and the
ning from the Run Test screen (Figure 6-2): Operator ID Entry. The time selected for the
1. Select Setup (Figure 6-2). System Shutdown determines the time
interval the instrument can be idle, while on
2. Select Interface Parameters (Figure 6-3).
battery power, before the instrument auto-
3. Select Spreadsheet (Figure 6-4). matically powers off. The time interval
4. On the Set Spreadsheet Parameters selected for the Operator ID Entry deter-
screen (Figure 6-15), select the desired mines the time duration the instrument can
Item Separation Character from the four remain idle before requiring operator identifi-
options. If the data will be used with Mi- cation to be entered in order to access the
crosoft® Excel®, select the comma. instrument.

5. Select up to five desired Line Termina- 6.1.8.1. System Shutdown

tion String from the three displayed The instrument contains a battery as a
(Carriage Return, Linefeed and ;) and/or backup power supply. The instrument will
use an external keyboard to enter other automatically shutdown after a specific
characters. The selections made appear in period of inactivity when it is running on the
the box below Line Termination String. battery.
Note that if carriage return is selected,
To select the amount of time desired to
<CR> appears in the box, and, if linefeed is
elapse before shutdown, use the following
selected, <LF> appears. If the data will be
steps beginning from the Run Test screen
used with Microsoft® Excel®, select Car-
(Figure 6-2):
riage Return.
1. Select Setup (Figure 6-2).
6. To remove the selected line termination
string, select Clear. 2. Select Interface Parameters (Figure 6-3).
7. Select Yes for Include column labels to 3. Select System Timers (Figure 6-4).
have the column labels saved with the data. 4. On the Select Timer screen (Figure
If the data will be used with Microsoft® 6-16), for System Shutdown, select Set
Excel®, select Yes. Time.
a. For patient tests, with all available da- 5. On the Select Shutdown Time-out
ta saved, the labels are: Test, Patient ID,
screen (Figure 6-17), use the up  and
Run Date, Run Time, Clotting Time (sec),
down  keys to select a time period of 15
Sex, Height, Weight, S/N, Operator ID,
min through 3 Hr - 0 min (3 hours), in
Date, Time, Range (lower), Range (upper),
fifteen minute increments.
Last Heparin Dosage (IU), Time Adminis-
tered, and Total Heparin.

6-6
ACTALYKE XL SIX - Setup

6. To save selections, return to the Run 6.2. General Parameters

Test screen (Figure 6-2) by selecting OK All of the parameters available may be setup
until the Run Test screen appears. through the General Parameters menu
6.1.8.2. Operator ID Entry without returning to the Run Test screen after
each selection; however, selections are not
The instrument can be setup to require an
saved until the instrument is returned to the
operator ID be entered after a selected time
Run Test screen.
interval of remaining idle. When setup to do
this, once the selected time has elapsed, the To access the General Parameters menu,
screen returns to the Enter Operator ID from the Run Test screen, select Setup, and
screen (Figure 6-1). then from the Setup screen, select General
Parameters.
The Operator ID Entry requirement only
applies to the main operator ID. If the Allow 6.2.1. Operator ID/Passwords
2nd Operator for Well 2 feature (section 1. The instrument’s use can be associated
6.2.3) is in use, the Operator ID Entry with an operator identification number or an
requirement will not prompt to re-enter the operator identification number / password /
well 2 operator ID. However, if a different ID access level combination.
is required for well 2, it must be re-entered
once the main/well 1 ID is entered (section 2. Up to 1000 sets of operator identification
7.1.3). information can be stored.
To select or edit this time interval, use the 3. If the operator identification numbers do
following steps beginning from the Run Test not need to be controlled, they do not need
screen (Figure 6-2): to be stored in the instrument's memory
and this section does not need to be com-
1. Select Setup (Figure 6-2). pleted.
2. Select Interface Parameters (Figure 6-3). a. Keep in mind however, that without
3. Select System Timers (Figure 6-4). the use of operator identification number /
password / access level combinations, all
4. On the Select Timer screen (Figure
users will have access to all areas of
6-16), for Operator ID Entry, select Yes to
instrument setup.
use the timer or No to turn the timer off.
b. Alternatively, if only Supervisor Full
5. If Yes is selected, the Select Operator ID
Rights and/or Setup Access operator ID
Time-out screen (Figure 6-18) displays.
numbers and passwords are setup, then
Use the keypad, Bksp (backspace), and
any main/well 1 user can gain Operation
Clear keys to select a time interval of 1
Only access by entering only an ID number
minute to 999 minutes, in one-minute
in the Enter Operator ID screen. Note that
increments.
if even one ID number and password
6. To save selections, return to the Run combination is setup with Operation Only
Test screen (Figure 6-2) by selecting OK access, this feature is no longer available.
until the Run Test screen appears.
4. The three security access levels are:
a. Operation only allows access to run
patient tests, QC tests, and enter patient
demographics; however, cannot alter the
instrument setup or delete QC data.
b. Setup Access allows the same ac-
cess as Operation Only plus access to all

6-7
ACTALYKE XL SIX - Setup

instrument setup except Operator 8. The screen displays, “Operation Only

ID/Passwords. Setup Access Supervisor Full Rights.”
Select the appropriate access level.
c. Supervisor Full Rights allows the
same access as Setup Access plus access 9. The screen returns to the Enter Operator
to Operator ID/ Passwords. ID List screen (Figure 6-20).
5. Note that if no operator ID is given 10. Select one of the following:
Supervisor Full Rights access, then the a. To enter or edit additional operator
operator ID(s) given the next highest ac- IDs, see step 4 of this section.
cess level will have access to all of
instrument setup. b. To remove any operator IDs, see
section 6.2.1.2 step 4.
6.2.1.1. Enter/Edit Operator ID/
Passwords c. To archive the current operator IDs to
a floppy disk, see section 6.2.1.3 step 4.
To enter and/or edit operator ID numbers,
passwords, and access levels, use the d. To change the initial/current operator
following steps beginning from the Run Test ID feature, see section 6.2.1.4 step 4.
screen (Figure 6-2): e. To save selections, return to the Run
1. Select Setup (Figure 6-2). Test screen (Figure 6-2) by selecting OK
until the Run Test screen appears.
2. Select General Parameters (Figure 6-3).
6.2.1.2. Delete Operator ID/
3. Select Operator ID/Passwords (Figure Passwords
6-19).
To delete an operator ID/password, use the
4. On the Enter Operator ID List screen following steps beginning from the Run Test
(Figure 6-20), an operator ID number can screen (Figure 6-2):
be entered/edited. Select one of the follow-
ing: 1. Select Setup (Figure 6-2).
a. To enter a new operator ID number, 2. Select General Parameters (Figure 6-3).
containing up to 15 characters, use the 3. Select Operator ID/Passwords (Figure
keypad, Bksp (backspace), and Clear keys, 6-19).
or a barcode reader.
4. On the Enter Operator ID List screen
b. To edit the password and/or access (Figure 6-20), use the , , , and
level for an existing ID number, use the  keys to indicate the desired operator ID
, , , and  keys to indicate the from the displayed list.
desired operator ID from the displayed list
and press the Sel key. 5. Select the Delete Selected key. The
screen displays, “Delete xx? No Yes,”
5. With the desired number in the New with xx the operator ID number to be delet-
Operator ID field, select Enter/Edit Pass- ed. To retain the operator ID/password,
word. select No. To remove the operator
6. On the Enter password screen (Figure ID/password, select Yes. The screen
6-21), enter or edit the password, contain- returns to Enter Operator ID List.
ing up to 15 characters, using the keypad, 6. Select one of the following:
Bksp (backspace), and Clear keys.
a. To remove additional operator IDs,
7. With the password entered, select OK. see step 4 of this section.

6-8
ACTALYKE XL SIX - Setup

b. To enter or edit operator IDs, pass- b. Select Restore and the screen dis-
words, and/or access levels, see section plays, “This will overwrite the existing
6.2.1.1 step 4. Operator ID List. Continue? No Yes.”
Select No to return to the Enter Operator ID
c. To archive the current operator IDs to
List screen without altering the list. Select
a floppy disk, see section 6.2.1.3 step 4.
Yes and the operator IDs saved on the
d. To change the initial/current operator floppy disk are copied to the instrument.
ID feature, see section 6.2.1.4 step 4.
c. Select Cancel to neither save nor re-
e. To save selections, return to the Run store the operator IDs.
Test screen (Figure 6-2) by selecting OK
7. The screen returns to Enter Operator ID
until the Run Test screen appears.
List (Figure 6-20). If IDs were restored, turn
6.2.1.3. Archive and Retrieve off the instrument, wait 10 seconds, and turn
Operator IDs on the instrument; otherwise, select one of
The currently entered list of operator identifi- the following:
cation number / password / access level a. To enter or edit operator IDs, pass-
combinations can be archived to a floppy words, and/or access levels, see
disk. Archiving the operator IDs allows: the section 6.2.1.1 step 4.
list to be retrieved if the instrument’s list is
b. To remove any operator IDs, see
inadvertently altered; the same list to be
section 6.2.1.2 step 4.
saved on multiple instruments thus eliminat-
ing the need to reenter each ID. To archive c. To change the initial/current operator
(save) or retrieve (restore) operator IDs, use ID feature, see section 6.2.1.4 step 4.
the following steps beginning from the Run d. To save selections, return to the Run
Test screen (Figure 6-2): Test screen (Figure 6-2) by selecting OK
1. Select Setup (Figure 6-2). until the Run Test screen appears.
2. Select General Parameters (Figure 6-3). 6.2.1.4. Initial Operator ID
3. Select Operator ID/Passwords (Figure The current operator ID can show on the
6-19). Enter Operator ID screen requiring that only
the password be re-entered, if preferred. To
4. The Enter Operator ID List screen
set the initial/current ID to show, use the
(Figure 6-20) displays. Confirm the appro-
following steps beginning from the Run Test
priate floppy disk is in the disk drive (see
screen (Figure 6-2):
Error! Reference source not found. for
floppy disk drive location). 1. Select Setup (Figure 6-2).
5. Select the Save/Restore key and the 2. Select General Parameters (Figure 6-3).
screen displays, “Save/Restore IDs to/from 3. Select Operator ID/Passwords (Figure
floppy. Save Restore Cancel.”
6-19).
6. Select one of the following: 4. On the Enter Operator ID List screen
a. Select Save and the operator IDs cur- (Figure 6-20), select Initial.
rently entered are saved to the floppy disk. 5. The screen displays, "Use previous ID
If the disk in use has been used before to entry as default when entering new ID? No
save IDs, the instrument prompts to notify Yes." To leave the current operator ID
that the file will be overwritten. To proceed, showing on the Enter Operator ID screen
select Yes. whenever it is accessed, select Yes. To
remove the operator ID, select No.

6-9
ACTALYKE XL SIX - Setup

6. From the Enter Operator ID List screen, c. Select Always and patient information
select one of the following: can be entered, displayed, printed, saved
and/or exported. With Always selected,
a. To enter or edit additional operator
patient information must be entered with
IDs, see section 6.2.1.1 step 4.
every test run; however, when the infor-
b. To remove any operator IDs, see mation is entered, before, during or after the
section 6.2.1.2 step 4. test, is at the user’s discretion. If the infor-
c. To archive the current operator IDs to mation is not entered before running a test,
a floppy disk, see section 6.1.2.3 step 4. once the test is started, the instrument
prompts the user that patient information
d. To save selections, return to the Run must be entered. If the information is not
Test screen (Figure 6-2) by selecting OK entered during the run of the test, once the
until the Run Test screen appears. test is complete, the instrument displays the
6.2.2. Patient screen used to enter patient information.
The instrument can be setup to allow patient d. Select Immediate and patient infor-
identification and demographic information to mation can be entered, displayed, printed,
be entered and used to identify test results. saved and/or exported. With Immediate
Note that Patient ID Entry must be set to On, selected, patient information must be
Always or Immediate for the following entered with every test run. If the infor-
available options to function: viewing and mation is not entered before starting a test,
printing patient data in chart form, exporting once a test is started, the instrument
data to an external computer (LIS), saving displays the screen used to enter patient
data to a floppy disk, and entering heparin information.
dosages. To select which, if any, patient 5. Default Test is recommended for use if
information is to be entered, use the follow- only one test type (C-ACT, K-ACT, G-ACT,
ing steps beginning from the Run Test or MAX-ACT) will be run. With this feature
screen (Figure 6-2): in use, the test type only needs to be
1. Select Setup (Figure 6-2). selected once (or possible once per well)
until/unless the entire patient list is cleared
2. Select General Parameters (Figure 6-3). at that time a test will again have to be
3. Select Patient (Figure 6-19). selected (per well). If multiple test types
will be used, do not use this feature. To
4. On the Select Editable Demographics use the Default Test feature, select Yes;
screen (Figure 6-22), for Patient ID Entry otherwise, select No.
select one of the following:
6. ID Auto Entry Interval (Hrs) is only
a. Select Off and no patient information available when Patient ID Entry is set to
can be entered, displayed, printed, saved, On. The ID Auto Entry Interval is used to
or exported. control if, and when, the instrument
b. Select On and patient information can prompts the user that no change in the
be entered, displayed, printed, saved patient ID has occurred for a given amount
and/or exported. With On selected, patient of time. Select from Off, 1, 2, 3, 4, and 5.
information is entered at the user’s discre- Select Off if no prompt to enter a patient ID
tion, unless ID Auto Entry Interval is in use. is desired. Select from 1 through 5, to have
If no patient ID is entered, the printout will that number of hours pass between a
contain “Patient ID_________” allowing the patient ID being entered and the instrument
ID to be handwritten. prompting the user that no change has
occurred in the patient ID. With this feature

6-10
ACTALYKE XL SIX - Setup

activated, a patient ID must be entered c. Only setup operator ID / passwords

when prompted. (section 6.2.1) can access the unit as well 2
operator;
7. Up to three patient demographics, Sex,
Height, and Weight, may be included in the d. If the well 1/main operator ID is
patient ID information. Select No or Yes to changed (section 7.1.3), the well 2 ID must
indicate the desired demographics. Note be re-entered/changed or the well 1 ID will
that Patient ID Entry must be set to On, be attributed to both wells;
Always or Immediate to use any of the e. If the operator ID is set to printout
demographics. (Note that if Patient IDs are (section 6.1.5), then if the results chart is
currently attributed to the test wells and printed, it includes the ID of the operator
then any of the three patient demographics who ran the tests and the operator currently
are set to Yes, the instrument will not in use;
automatically require the demographics be
selected for the current Patient IDs. It is f. Care should be taken that the correct
recommended the correct demographics be operator uses their assigned well.
selected prior to running additional tests.) 6. Use ACT Timing Sequence to have the
8. To save selections, return to the Run instrument prompt after a specified amount
Test screen (Figure 6-2) by selecting OK of time has passed since the last ACT test
until the Run Test screen appears. was run. (Note the timing sequence does
not begin until an ACT test is run. If the
6.2.3. Test timing sequence setting is altered, the timer
The instrument can be setup to allow a does not begin again until another ACT test
different operator ID for well 2, to prompt is run.) (Note, with this feature in use, once
when a specified amount of time has elapsed the selected time interval has elapsed, for
since the last ACT test was run, and/or to the prompt to run an ACT test to display,
include the ACT test ranges when printing, the instrument must not be in QC mode
saving, and exporting. To setup these and the Run Test screen must be clear of
parameters, use the following steps begin- any clotting time results.)
ning at the Run Test screen (Figure 6-2): a. Select Yes to set, or change, the time
1. Select Setup (Figure 6-2). interval.
2. Select General Parameters (Figure 6-3). b. The ACT Timing Sequence screen
(Figure 6-24) displays.
3. Select Test (Figure 6-19).
c. Use the keypad, Bksp (backspace)
4. The Setup Test Parameters screen
and Clear keys to enter the desired time
(Figure 6-23) displays.
duration, from one to 999 minutes, between
5. Use Allow 2nd Operator for well 2 to allow tests.
a different operator ID to be assigned to
d. With the desired time entered, select
well 2. Select Yes to allow an operator for
OK to return to the Setup Test Parameters
well 2. With this feature in use:
screen (Figure 6-23).
a. The access level of the ID assigned
7. Use High/Low Limits to include the ACT
to well 1, the main ID, determines the
test range limits on ACT chart printouts and
access level for both users;
when test data is saved and/or exported.
b. If no ID is assigned to well 2, and Additionally, with this feature in use, if test
well 2 is used, the well 1 ID will be attribut- results fall outside the limits, a notation is
ed to the results; included along with the test time, on all
printouts and when data is saved and/or

6-11
ACTALYKE XL SIX - Setup

exported. If the results are below the lower are then used to determine the mean. There
limit, an "L" appears after the test time, are two ways to enter the range limits (and
and, if they are over the upper limit, an "H" lot numbers). One uses an optional barcode
appears. Note: Do not use this feature if reader, see section 8.1.2. The second uses
multiple ACT test types are to be run. The the instrument’s touch screen to key in the
range limits will not include the name of the information, see section 6.2.4.3.
ACT test and will print, save and transmit 6.2.4.1. QC(bio) Levels Which Must
with all patient data generated. Pass
a. Select Yes to enter, or change, the If desired, the instrument can require that
limits. certain levels of biological QC pass before
b. The ACT Test Range Limits screen patient tests can be run.
(Figure 6-25) displays. To select the level or levels required, use the
c. Select either the Lower or Upper key following steps beginning from the Run Test
and use the keypad, Bksp (backspace) and screen (Figure 6-2):
Clear keys to enter the limit. Refer to the 1. Select Setup (Figure 6-2).
procedure provided with the ACT test for
“reference” or “expected” ranges. Select 2. Select General Parameters (Figure 6-3).
the other limit key, either Lower or Upper, 3. Select QC (Bio) (Figure 6-19).
and use the keypad, Bksp (backspace) and
Clear keys to enter that limit. 4. The Setup QC(bio) screen (Figure 6-26)
displays. Select the desired QC(bio) levels
d. With the range limits entered, select which must pass, 1, 2, and/or 3. The level
OK to return to the Setup Test Parameters number(s) will display. To de-select a
screen (Figure 6-23). level, select that level number and it will be
8. To save selections, return to the Run removed from the list of must pass levels.
Test screen (Figure 6-2) by selecting OK 5. Select one of the following:
until the Run Test screen appears.
a. To alter the Schedule, see sec-
6.2.4. QC (Bio) tion 6.2.4.2 step 4.
The instrument can be setup to require b. To enter lot numbers and/or range
certain levels of biological QC tests pass limits for an ACT control, see section
before patient tests are run, see sec- 6.2.4.3 step 4.
tion 6.2.4.1.
c. To save selections, return to the Run
The instrument can also be setup to prompt Test screen (Figure 6-2) by selecting OK
the user when a specified amount of time until the Run Test screen appears.
has elapsed since the last biological QC test
was run, see section 6.2.4.2. 6.2.4.2. Set QC(bio) Schedule
To require biological QC be run on a routine The interval between biological QC tests can
basis, both of these features must be setup be from 1 to 200 hours. The shortest time
for use. Note that this requirement can be duration remaining, QC(bio) or ECT (section
6.2.5), is displayed on the Run Test screen
temporarily overridden by Supervisor Full on the top, left corner. Once the time
Rights access operators and, if the Allow 2nd elapses, the instrument alerts the user a
Operator for Well 2 feature is in use, by both QC(bio) test is due. If a QC(bio) test is run
operators the well 1/main operator ID in use prior to the next scheduled time, the instru-
has Supervisor access. ment will reset based on when that test is
The range limits included with the biological run. (Note that once the selected time
QC test procedures should be entered. They interval has elapsed, the prompt to run a

6-12
ACTALYKE XL SIX - Setup

QC/ECT test will not appear until any existing To use the touch screen to enter lot numbers
time results displayed on the Run Test and/or range limits, use the following steps
screen are cleared.) beginning from the Run Test screen (Figure
To select the desired time interval between 6-2):
biological QC tests, use the following steps 1. Select Setup (Figure 6-2).
beginning from the Run Test screen (Figure
6-2): 2. Select General Parameters (Figure 6-3).

1. Select Setup (Figure 6-2). 3. Select QC (Bio) (Figure 6-19).

2. Select General Parameters (Figure 6-3). 4. On the Setup QC(bio) screen (Figure
6-26), select C-ACT, K-ACT, G-ACT, or
3. Select QC (Bio) (Figure 6-19). MAX-ACT.
4. On the Setup QC(bio) screen (Figure 5. On the QC Lot Numbers screen (Figure
6-26), select Set QC(bio) Schedule. 6-28), to enter or change the lot number for
5. On the QC(bio) Schedule screen (Figure a specific level, select the desired Level of
6-27), use the keypad, Bksp (backspace), 1, 2 or 3.
and Clear keys to enter or alter the desired 6. On the Enter Lot Number screen (Figure
time interval between biological QC tests. 6-29), use the keypad, Bksp (backspace),
For example, if weekly biological QC is and Clear keys to enter or change the lot
required, set the schedule to 168 hours. number containing up to ten characters.
6. To return to the Setup QC(bio) screen 7. Select OK and the screen returns to the
without restarting the timer or changing the QC Lot Number screen (Figure 6-28) and
time, select Cancel. includes the entered lot number. To enter
7. Select OK to return to the Setup QC(bio) or edit the lot numbers of the other levels,
screen (Figure 6-26). Note that the instru- see step 5. To enter the range limits of the
ment starts the timer for the QC tests once levels displaying lot numbers, select OK and
OK is selected. see step 8. To exit without entering any
range limits, select OK until the Setup
8. Select one of the following: QC(bio) screen (Figure 6-26) displays and
a. To alter the QC(bio) Levels Which see step 12.
Must Pass, see section 6.2.4.1 step 4. 8. Use the QC Mean and Range screen
b. To enter lot numbers and/or range (Figure 6-30) to enter or edit the range
limits for an ACT control, see section limits. Select the desired Level of 1, 2 or 3.
6.2.4.3 step 4. Note that only the levels for which lot
numbers have been entered appear on this
c. To save selections, return to the Run screen.
Test screen (Figure 6-2) by selecting OK
until the Run Test screen appears. 9. On the Enter Lower Limit screen (Figure
6-31), use the keypad, Bksp (backspace),
6.2.4.3. C-ACT, K-ACT, G-ACT, and and Clear keys to enter or edit the Lower
MAX-ACT Limit and select OK.
For each biological QC test type and level, 10. On the Enter Upper Limit screen
the lot number and/or range limits can be (Figure 6-31), use the keypad, Bksp (back-
entered. The instrument uses the entered space), and Clear keys to enter or edit the
range limits to calculate mean. The infor- Upper Limit and select OK.
mation can be entered either by using the
touch screen (instructions to follow) or using 11. The screen returns to the QC Mean and
an optional barcode reader (section 8.1.2). Range screen (Figure 6-30) and includes

6-13
ACTALYKE XL SIX - Setup

the entered range limits and the mean, 2. Select General Parameters (Figure 6-3).
calculated by the instrument from the 3. Select ECT (Figure 6-19).
entered limits. To enter or edit limits for
other levels, see step 8. To return to the 4. The Setup ECT screen (Figure 6-32)
Setup QC(bio) screen (Figure 6-26), select displays. Select the desired ECT levels
OK. which must pass, 1, 2, and/or 3. The level
number(s) will display. To de-select a
12. From the Setup QC(bio) screen (Figure level, select that level number and it will be
6-26), select one of the following: removed from the list of must pass levels.
a. To alter the QC(bio) Levels Which 5. Select one of the following:
Must Pass, see section 6.2.4.1 step 4.
a. To alter the Schedule, see sec-
b. To alter the Schedule, see sec- tion 6.2.5.2 step 4.
tion 6.2.4.2 step 4.
b. To save selections, return to the Run
c. To enter or edit QC lot numbers Test screen (Figure 6-2) by selecting OK
and/or range limits for additional tests, see until the Run Test screen appears.
step 4 of this section.
6.2.5.2. Set ECT Schedule
d. To save selections, return to the Run
Test screen (Figure 6-2) by selecting OK The interval between ECT tests can be from
until the Run Test screen appears. one to 200 hours. The shortest time duration
remaining, QC(bio) (section 6.2.4) or ECT, is
6.2.5. ECT displayed on the Run Test screen on the top,
The instrument can be setup to require left corner. Once the time elapses, the
certain levels of ECT tests pass before instrument alerts the user an ECT test is due.
If an ECT test is run prior to the next sched-
patient test can be run, see section 6.2.5.1.
uled time, the instrument will reset based on
The instrument can also be setup to prompt when that test is run. (Note that once the
the user when a specified amount of time selected time interval has elapsed, the
has elapsed since the last ECT test was run, prompt to run a QC/ECT test will not appear
see section 6.2.5.2. until any existing time results displayed on
the Run Test screen are cleared.)
To require ECTs be run on a routine basis,
both of these features must be setup for use. To select the desired time interval between
Note that this requirement can be temporarily ECT tests, use the following steps beginning
overridden by Supervisor Full Rights access from the Run Test screen (Figure 6-2):
operators and, if the Allow 2nd Operator for 1. Select Setup (Figure 6-2).
Well 2 feature is in use, by both operators if
the well 1/main operator ID in use has 2. Select General Parameters (Figure 6-3).
Supervisor access. 3. Select ECT (Figure 6-19).
6.2.5.1. ECT Levels Which Must 4. On the Setup ECT screen (Figure 6-32),
Pass select Set ECT Schedule.
If desired, the instrument can require that 5. On the ECT Schedule screen (Figure
certain ECT levels pass before patient tests 6-33), use the keypad, Bksp (backspace),
can be run. and Clear keys to enter or alter the desired
To select the level or levels required, use the time interval between ECT tests. For
following steps beginning from the Run Test example, if ECT testing is required once
screen (Figure 6-2): every 8 hours, set to 8 hours.

1. Select Setup (Figure 6-2).

6-14
ACTALYKE XL SIX - Setup

6. To return to the Setup ECT screen Entry is not in use, this automatic printing is
without restarting the timer or changing the the only way to print test results.
time, select Cancel. (3) Select Chart to have QC Levey-
7. Select OK to return to the Setup ECT Jennings charts and patient ACT results
screen (Figure 6-32). Note that the instru- charts automatically printed once a test is
ment starts the timer for the ECT tests once complete. Regardless of selection, the
OK is selected. charts can be printed at user request, see
sections 7.1.2 and 8.1.3. Note that if
8. Select one of the following:
patient data is to be printed in chart form,
a. To alter the ECT Levels Which Must either automatically or manually, Patient ID
Pass, see section 6.1.5.1 step 4. Entry (section 6.2.2) must be in use.
b. To save selections, return to the Run c. Transmit - allows patient and QC data
Test screen (Figure 6-2) by selecting OK to be automatically sent to an external
until the Run Test screen appears. computer (LIS). Note if patient data is to be
6.2.6. Auto Output transmitted, either automatically or manual-
ly, Patient ID Entry (section 6.2.2) must be
The instrument can display, print, save, and/ in use.
or transmit test data automatically. To setup
the instrument to automatically output these (1) Select All to have the complete
functions, use the following steps beginning curve from both the patient Results ACT
from the Run Test screen (Figure 6-2): chart and QC Levey-Jennings chart auto-
matically transmitted. The curve is
1. Select Setup (Figure 6-2). automatically transmitted at the completion
2. Select General Parameters (Figure 6-3). of a test.
3. Select Auto Output (Figure 6-19). (2) Select One to have a single point
from both the patient Results ACT chart
4. Select, on the Setup Automatic Output and QC Levey-Jennings chart automatically
screen (Figure 6-34), the desired setting for transmitted. The point is automatically
the following parameters: transmitted at the completion of a test.
a. View Chart - select Yes to have QC (3) If No is selected, the data can be
Levey-Jennings charts and patient Results transmitted at user request, see sec-
ACT charts automatically displayed once a tions 7.1.2 and 8.1.3.
test is complete. If No is selected, the
charts can be displayed at user request, d. Save Patient (spreadsheet) - select
see sections 7.1.2 and 8.1.3. Note that if Yes to have patient ACT results automati-
patient data is to be viewed, either auto- cally saved on a 3½” floppy disk. All
matically or manually, Patient ID Entry clotting times for the current patients are
(section 6.2.2) must be in use. Also, note saved each time a run is completed. The
that when tests are run in well 2, the chart results are saved as file name
will not always automatically display, but Pxxxxxxx.csv, with xxxxxxx the last 7 digits
can be accessed manually. of the unit's serial number. If No is select-
ed, the results can be saved at user
b. Print - request, see section 7.1.2. Note if patient
(1) Select None to have no infor- data is to be saved, Patient ID Entry (sec-
mation automatically print. tion 6.2.2) must be in use.
(2) Select Simple to have all test re- e. Save QC (spreadsheet) - select Yes
sults automatically print once a test is to have the QC results containing all data
complete. For patient data, if Patient ID per lot-to-date automatically saved on a

6-15
ACTALYKE XL SIX - Setup

3½” floppy disk. The results are saved as 3. From the Save/Restore/Print screen
file name Qxxxxxxx.csv, with xxxxxxx the (Figure 6-35), select Save Parameters.
last 7 digits of the unit's serial number. If 4. If the disk in use has been used before
No is selected, the results can be saved at to save parameters, the instrument prompts
user request, see section 8.1.3. to notify that the file will be overwritten. To
5. To save selections, return to the Run proceed, select Yes.
Test screen (Figure 6-2) by selecting OK 5. The parameters are saved and the
until the Run Test screen appears. Save/Restore/Print screen displays.
6.3. Paper Feed 6. To return to the Run Test screen (Figure
The Paper Feed key is used to advance the 6-2), select OK until the Run Test screen
printer paper to aid in loading a roll of paper appears.
and in reading and/or removing a printout. 6.4.2. Restore Parameters
This key will appear on the Run Test screen
if the operator ID in use has an Operation If setup parameters have been saved to a
Only access level. However the Paper Feed 3½" floppy disk, they can be restored to the
key is accessed, press the key as many instrument or restored to a different instru-
times as needed for the paper to advance ment. To restore the parameters, with the
the desired amount. To access this key for appropriate disk in the floppy disk drive, use
other operator ID access levels, use the the following steps beginning from the Run
following steps beginning from the Run Test Test screen (Figure 6-2):
screen (Figure 6-2): Select Setup (Figure 6-2).
1. Select Setup (Figure 6-2). Select Archive (Figure 6-3).
2. Select Paper Feed (Figure 6-3) and the From the Save/Restore/Print screen (Figure
printer advances the paper. 6-35), select Restore Parameters.
3. Continue to select Paper Feed until the The instrument prompts to notify that the
paper has advanced as far as needed. instrument's file will be overwritten. To
4. To return to the Run Test screen (Figure proceed, select Yes.
6-2), select OK until the Run Test screen The parameters are saved to the instrument
appears. and the Save/Restore/Print screen displays.
6.4. Archive To return to the Run Test screen (Figure
To access the Archive menu, from the Run 6-2), select OK until the Run Test screen
Test screen, select Setup. From the Setup appears.
screen, select Archive. 6.4.3. Print Setup Parameters
6.4.1. Save Parameters To obtain a printout of the selections made
The currently set parameters can be saved to during setup, except operator IDs (section
a 3½" floppy disk. This can then be used to 6.4.6), and some of the current settings in
restore the parameters if needed or to save on QC, use the following steps beginning from
to a different instrument (section 6.4.2). To the Run Test screen (Figure 6-2):
save the parameters, with a disk in the floppy 1. Select Setup (Figure 6-2).
disk drive, use the following steps beginning
from the Run Test screen (Figure 6-2): 2. Select Archive (Figure 6-3).
1. Select Setup (Figure 6-2). 3. From the Save/Restore/Print screen
(Figure 6-35), select PRINT Setup Parame-
2. Select Archive (Figure 6-3). ters. The screen prompts with the length of

6-16
ACTALYKE XL SIX - Setup

time the printout will take. To proceed, select qc_sched:

ect_sched:
Yes.
REPORT/INTERFACE PARAMETERS
4. A printout containing the following infor- date_format:
mation plus the instruments currently time_mode:
snd_click:
entered settings for each parameter prints. snd_warn:
Actalyke XL Parameters snd_RunDone:
================== prn_header:
Version prn_footer:
Instrument S/N: prn_sn:
Operator ID: prn_techid:
Date: prn_date:
Time: prn_time:
xp_prot:
PATIENT EDITING PARAMETERS
xp_databits:
patident:
xp_stopbits:
idautoent_interval:
xp_parity:
sex:
xp_baudofs:
height:
backlite:
weight:
linterm:
TEST PARAMETERS sepchar:
act_seq:
limit: 5. The following is an explanation of the
act_seq_tim:
limit_hi:
above printout. Note that all the text pre-
limit_lo: sented in bold could appear on the printout
opid2: similar to this.
OpIdUsePrev:
DefaultTest: a. This explanation includes the section
AUTO-OUTPUT PARAMETERS number where additional information can
aviewchart:
adataprint: be found related to setting up the parame-
atransmit: ters. For example, PATIENT EDITING
apatstorage: PARAMETERS is in section 6.2.2.
aqcstorage:
QC PARAMETERS b. The explanation also includes clarifi-
well_lvl: cations of the headings that appear on the
tubetype:
mean: printout (presented within parentheses).
ECT: For example, the patident heading is short
MAX-ACT: for Patient ID Entry.
G-ACT:
K-ACT: c. Lastly, the explanation includes the
C-ACT:
range_hi: possible settings that appear after the
ECT: headings (presented in bold) and their
MAX-ACT: meanings (presented within parentheses).
G-ACT:
K-ACT: For example, 0 can represent Off, No or
C-ACT: none.
range_lo:
ECT:
MAX-ACT:
Actalyke XL Parameter
G-ACT: ===================
K-ACT: Version: (printout will list current software
C-ACT:
lotnum: version information)
ECT: Instrument S/N (instrument serial number):
MAX-ACT: (printout will list the pre-programmed
G-ACT:
K-ACT: instrument serial number)
C-ACT:
qc_forced:
ect_forced:

6-17
ACTALYKE XL SIX - Setup

Operator ID: (the identification number of tubetype (test tube type): (printout will list
the operator currently accessing the the pre-selected tube type for each test
instrument) well) 0 (none), 1 (ECT), 2 (MAX-ACT),
Date: (current date) 3 (G-ACT), 5 (K-ACT), or 6 (C-ACT)
Time: (current time) mean (Set QC Mean and Range):
PATIENT EDITING PARAMETERS ECT: 100, 300, 500
(section 6.2.2) MAX-ACT:
patident (Patient ID Entry): 0 (Off), 1 (On), (level 1 automatically calculated mean),
2 (Always), or 3 (Immediate) (level 2 automatically calculated mean),
(level 3 automatically calculated mean)
idautoent_interval (ID Auto Entry Interval):
0 (Off), 1 (1), 2 (2), 3 (3), 4 (4), or 5 (5) G-ACT:
sex: 0 (No) or 1 (Yes) (level 1 automatically calculated mean),
(level 2 automatically calculated mean),
height: 0 (No) or 1 (Yes) (level 3 automatically calculated mean)
weight: 0 (No) or 1 (Yes)
K-ACT:
TEST PARAMETERS (section 6.2.1, 6.2.2, (level 1 automatically calculated mean),
and 6.2.3) (level 2 automatically calculated mean),
act_seq (ACT Timing Sequence): (level 3 automatically calculated mean)
0 (No) or 1 (Yes) C-ACT:
limit (ACT Test Range Limits): (level 1 automatically calculated mean),
0 (No) or 1 (Yes) (level 2 automatically calculated mean),
act_seq_tim (ACT Timing Sequence): (level 3 automatically calculated mean)
(the selected interval of time in minutes range_hi (QC Mean and Range Upper
between ACT tests) Limit):
limit_hi (ACT Test Range Limits Upper): ECT: 110, 310, 510
(the entered upper limit in seconds) MAX-ACT:
limit_lo (ACT Test Range Limits Lower): (level 1 upper limit),
(the entered lower limit in seconds) (level 2 upper limit),
Opid2 (Allow 2nd Operator for Well 2): 0 (level 3 upper limit)
(No) or 1 (Yes) G-ACT:
OpIdUsePrev (Initial): 0 (No) or 1 (Yes) (level 1 upper limit),
DefaultTest (Default Test): 0 (No) or 1 (Yes) (level 2 upper limit),
AUTO-OUTPUT PARAMETERS (level 3 upper limit)
(section 6.2.6) K-ACT:
aviewchart (automatically View Chart): (level 1 upper limit),
0 (No) or 1 (Yes) (level 2 upper limit),
adataprint (automatically Print): (level 3 upper limit)
0 (None), 1 (Simple) or 2 (Chart) C-ACT:
atransmit (automatically Transmit chart): (level 1 upper limit),
0 (No), 1 (One) or 2 (All) (level 2 upper limit),
apatstorage (automatically Save Patient):
(level 3 upper limit)
0 (No) or 1 (Yes)
range_lo (QC Mean and Range Lower
aqcstorage (automatically Save QC):
Limit):
0 (No) or 1 (Yes)
ECT: 90, 290, 490
QC PARAMETERS (section 6.2.4 and 6.2.5) MAX-ACT:
well_lvl (well level): (printout will list the (level 1 lower limit),
current level for each test well) (level 2 lower limit),
0 (1), 1 (2) or 2 (3) (level 3 lower limit)

6-18
ACTALYKE XL SIX - Setup

G-ACT: REPORT/INTERFACE PARAMETERS

(level 1 lower limit), (sections 6.1.2, 6.1.3, 6.1.4, 6.1.5, 6.1.6,
(level 2 lower limit), and 6.1.7)
(level 3 lower limit) date_format (Date Format):
K-ACT: 0 (dd/mm/yy), 1 (dd/mm/yyyy),
(level 1 lower limit), 2 (yy/mm/dd), 3 (yyyy/mm/dd),
4 (mm/dd/yy), 5 (mm/dd/yyyy), or
(level 2 lower limit),
6 (MMM dd, yyyy)
(level 3 lower limit)
time_mode (Time mode):
C-ACT: 0 (12 Hr mode) or 1 (24 Hr mode)
(level 1 lower limit), snd_click (Sound Click):
(level 2 lower limit), 0 (None), 1 (1), 2 (2), 3 (3), 4 (4), or 5 (5)
(level 3 lower limit) snd_warn (Sound Warning):
lotnum (QC test Lot Numbers): 0 (None), 1 (1), 2 (2), 3 (3), 4 (4), or 5 (5)
ECT: ‘ ’, ‘ ’, ‘ ’ snd_RunDone (Sound Run Done):
MAX-ACT: 0 (None), 1 (1), 2 (2), 3 (3), 4 (4), or 5 (5)
‘(lot number for level 1)’, prn_header (Print Header):
‘(lot number for level 2)’, (printout will list the header, if entered)
‘(lot number for level 3)’ prn_footer (Print Footer):
G-ACT: (printout will list the footer, if entered)
‘(lot number for level 1)’, prn_sn (Print Serial Number):
‘(lot number for level 2)’, 0 (No) or 1 (Yes)
prn_techid (Print Operator ID):
‘(lot number for level 3)’
0 (No) or 1 (Yes)
K-ACT:
prn_date (Print Date): 0 (No) or 1 (Yes)
‘(lot number for level 1)’,
prn_time (Print Time): 0 (No) or 1 (Yes)
‘(lot number for level 2)’,
xp_prot (Export Parameters Protocol):
‘(lot number for level 3)’
0 (None), 1 (XON-XOFF), or 2 (ASTM)
C-ACT:
xp_databits (Export Parameters Data Bits):
‘(lot number for level 1)’,
0 (7) or 1 (8)
‘(lot number for level 2)’,
xp_stopbits (Export Parameters Stop Bits):
‘(lot number for level 3)’
0 (1) or 1 (2)
qc_forced (QC(bio) Levels Which Must
xp_parity (Export Parameters Parity):
Pass): 0 (none), 1 (1), 2 (2), 3 (1 and 2), 4
0 (None), 1 (Odd), or 2 (Even)
(3), 5 (1 and 3), 6 (2 and 3), or 7 (1, 2 and 3)
xp_baudofs (Export Parameters Baud
ect_forced (ECT Levels Which Must Pass):
Rate): 0 (300), 1 (1200), 2 (2400), 3
0 (none), 1 (1), 2 (2), 3 (1 and 2), 4 (3),
(4800), 4 (9600), 5 (14400), 6 (19200), 7
5 (1 and 3), 6 (2 and 3), or 7 (1, 2 and 3)
(28800), 8 (38400), or 9 (57600)
qc_sched (Set QC(bio) Schedule): (printout
backlite (Backlight): 0 (Off), 1 (1), 2 (2), 3
will list the entered time interval in hours)
(3), 4 (4), 5 (5), 6 (6), or 7 (Full On)
ect_sched (ECT Schedule): (printout will list
linterm (Spreadsheet Parameters Line
the entered time interval in hours)
Termination String): x0 x0 x0 x0 x0
[Up to five line terminators may be
selected. The four most common codes to
printout are x0 (no line terminator
selected), xd (carriage return), xA (line
feed), and ; (semicolon).]

6-19
ACTALYKE XL SIX - Setup

sepchar (Spreadsheet Parameters Item 5. The IDs are saved to the instrument and
Separation Character): , (comma), Tab the Save/Restore/Print screen displays.
(tab), : (colon), or ; (semicolon) 6. To complete the restore, turn the instru-
ment off, wait 10 seconds, and turn the
6. To return to the Run Test screen (Figure
instrument on.
6-2), select OK until the Run Test screen
appears. 6.4.6. Print Operator ID List
6.4.4. Save Operator IDs To obtain a printout of the current operator
IDs, use the following steps beginning from
The current operator IDs can be saved to a
the Run Test screen (Figure 6-2):
3½" floppy disk. They can then be used to
restore to the same instrument or to copy 1. Select Setup (Figure 6-2).
onto a different instrument (section 6.4.5). 2. Select Archive (Figure 6-3).
To save the IDs, with a disk in the floppy disk
drive, use the following steps beginning from 3. From the Save/Restore/Print screen
the Run Test screen (Figure 6-2): (Figure 6-35), select PRINT Operator ID
List. The screen prompts with the length of
1. Select Setup (Figure 6-2). time the printout will take. To proceed,
2. Select Archive (Figure 6-3). select Yes.
3. From the Save/Restore/Print screen 4. A printout containing the currently en-
(Figure 6-35), select Save Operator IDs. tered user ID numbers and access level
prints. The access levels are represented
4. If the disk in use has been used before
as follows: 0 for no access level assigned,
to save IDs, the instrument prompts to
1 for Operation Only, 2 for Setup Access,
notify that the file will be overwritten. To
and 3 for Supervisor Full Rights.
proceed, select Yes.
5. To return to the Run Test screen (Figure
5. The IDs are saved and the
6-2), select OK until the Run Test screen
Save/Restore/ Print screen displays.
appears.
6. To return to the Run Test screen (Figure
6.5. Maintenance
6-2), select OK until the Run Test screen
appears. The instrument provides for three mainte-
nance functions, which are accessed through
6.4.5. Restore Operator IDs
the Setup key. For information on these
If operator IDs have been saved to a 3½" maintenance functions, see section 10.1.9,
floppy disk, they can be restored to the Mag Sensor Calibration, section 10.1.6,
instrument or restored to a different instru- Drain Battery, and Touch Panel Calibration,
ment. To restore the IDs, with the section 10.1.5.
appropriate disk in the floppy disk drive, use
the following steps beginning from the Run
Test screen (Figure 6-2):
1. Select Setup (Figure 6-2).
2. Select Archive (Figure 6-3).
3. From the Save/Restore/Print screen
(Figure 6-35), select Restore Operator IDs.
4. The instrument prompts to notify that the
instrument's file will be overwritten. To
proceed, select Yes.
6-20
ACTALYKE XL SIX - Setup

* Enter Operator ID* *Setup*

Bksp Clear
General Interface
Parameters Parameters
Operator ID
1 2 3
0123
 Maintenance Archive
4 5 6
Password
 7 8 9
**** Paper
Feed
0

Must return to main screen

OK for changes to be saved OK

Figure 6-1. Enter Operator ID Screen* Figure 6-3. Setup Screen

or ECT Sched:, This area is
which ever has the Test key, if blank, if
least time remaining. Patient ID Patient ID
Time shown in Entry set Entry set
hours, minutes, and to Off. to Off.
seconds.

QC-B Sched: 0:59:47 *RUN TEST* Change *Setup Interface Parameters*

Operator

Start 1 Time & Date Printer

Patient ID
445-73-0049
Sound Export
Start 2
Keypad Spreadsheet
Patient ID
445-73-0049
Backlight System Timers

(1) (2) QC Patient ID

Temp(C): 37.0 37.0
Heater: OFF OFF
Tube: OUT OUT View
Charging Chart Setup
OK
or Charged or, if on Paper Feed key, if the level
battery power, Battery OK of Operator ID in use is
or Batt. LOW. Operation Only.

Figure 6-2. Run Test Screen Figure 6-4. Setup Interface Parameters
Screen

6-21
*Phone Keypad format shown.
ACTALYKE XL SIX - Setup

*Select Preferred Keypad* *Set Date Format*

dd/mm/yy dd/mm/yyyy
1 2 3 7 8 9
yy/mm/dd yyyy/mm/dd
4 5 6 4 5 6
mm/dd/yy mm/dd/yyyy
7 8 9 1 2 3
MMM dd, yyyy
0 0

Phone Calculator

OK OK

Figure 6-5. Select Preferred Keypad Figure 6-7. Set Date Format Screen
Screen

*Setup Time & Date* *Set Date*

Date Format 1 2 3

Date 4 5 6
12/23/2002
Time 7 8 9

< 0 >

OK Set Date OK

Figure 6-6. Setup Time & Date Screen Figure 6-8. Set Date Screen*

6-22
*Phone Keypad format shown.
ACTALYKE XL SIX - Setup

*Set Time* *Set Backlight*

1 2 3
Current Time
09:01:00 AM 4 5 6 Select Backlight Brightness Level
Off Full on
7 8 9
1 2 3 4 5 6
New Time < 0 >
09:01:00 AM

12/24 Hr AM/PM Set Time Exit OK

Figure 6-9. Set Time Screen* Figure 6-11. Set Backlight Screen

*Setup Sound* *Setup Printer*

Contrast Header Footer
Click--------- NONE 1 2 3 4 5
Include on printed report
(and with spreadsheet file):
Warning----- NONE 1 2 3 4 5
Serial Number---------- No Yes
(chart only)
Run Done-- NONE 1 2 3 4 5
Operator ID-------------- No Yes

Date----------------------- No Yes

Time----------------------- No Yes
OK OK

Figure 6-10. Setup Sound Screen Figure 6-12. Setup Printer Screen

6-23
*Phone Keypad format shown.
ACTALYKE XL SIX - Setup

*Printer Contrast Adjustment* *Set Spreadsheet Parameters*

Item Separation
Character , Tab : ;
(Column Delimiter)


Line Carriage
Contrast: 10 Termination
 String
Return Linefeed ;

 <CR> <LF>

 Other line termination

characters may be added
via an external keyboard
Undo Clear
Include column
No Yes
OK labels OK

Figure 6-13. Printer Contrast Adjustment Figure 6-15. Set Spreadsheet Parameters
Screen Screen

*Setup Export Parameters* Select timer to be changed:

Protocol---- NONE Xon-Xoff ASTM

Data Bits--- 7 8
System Shutdown---------- Set Time
Parity-------- NONE Odd Even

Stop Bits--- 1 2 Operator ID entry------------ NO YES


Baud Rate-- 9600


OK OK

Figure 6-14. Setup Export Parameters Figure 6-16. Select Timer Screen
Screen

6-24
ACTALYKE XL SIX - Setup

*Select Shutdown Time-out* *General Parameters*

On battery power, system will

Patient
shut-down after the specified
time of inactivity. Operator ID/
Passwords
Test

3Hr - 0 min Auto Output

QC (Bio)

ECT
OK OK

Figure 6-17. Select Shutdown Time-out Figure 6-19. General Parameters Screen
Screen
Access Level of the currently indicated Operator
ID: 0 (no level assigned), 1 (Operation Only),
2 (Setup Access), 3 (Supervisor Full Rights)

*Select operator ID time-out* *Enter Operator ID List*

Initial
New Operator ID Access
When the instrument has Bksp Clear Level Bksp Clear
remained idle for the specified
amount of time, operator ID
will again be required. Enter/Edit 
1 2 3 Password 1 2 3

1111
4 5 6 2222 Sel 4 5 6
3333
minutes  7 8 9
7 8 9 4444

- 0
0 Total Quant = 4
Save/
Delete Selected OK
OK Restore

Total number of IDs

currently in list.

Figure 6-18. Select Operator ID Time-out Figure 6-20. Enter Operator ID List
Screen* Screen*

6-25
*Phone Keypad format shown.
ACTALYKE XL SIX - Setup

Enter password *Setup Test Parameters*

Bksp Clear Allow 2nd Operator------- NO YES

for well 2

1 2 3 ACT Timing Sequence--- NO YES

4 5 6
High/Low Limits------------ NO YES
7 8 9

- 0

OK OK

Figure 6-21. Passwords Screen* Figure 6-23. Setup Test Parameters

Screen

*Select Editable Demographics* *ACT Timing Sequence*

Patient ID Bksp Clear

Entry
OFF ON Always Immediate
Perform ACT every 1 2 3
ID Auto Entry
Interval OFF 1 2 3 4 5
(Hrs)
4 5 6
minutes
Sex NO YES 7 8 9
Default Test
Height NO YES
NO YES 0
Weight NO YES
OK OK

Figure 6-22. Select Editable Figure 6-24. ACT Timing Sequence

Demographics Screen Screen*

6-26
*Phone Keypad format shown.
ACTALYKE XL SIX - Setup

*ACT Test Range Limit* *QC(bio) Schedule*

Bksp Clear Bksp Clear

Enter Acceptable Limits
Run QC(bio) every
Lower Upper 1 2 3 1 2 3

4 5 6 hour(s) 4 5 6
(seconds) (seconds)

7 8 9 7 8 9

0 0

OK OK Cancel

Figure 6-25. ACT Test Range Limits Figure 6-27. QC(bio) Schedule Screen*
Screen*

*Setup QC(bio)* *QC Lot Numbers*

QC(bio) levels which 1 2 3
must pass: Test: C-ACT
Level Lot Number
Set QC(bio)
Schedule
1
Enter Parameters for:

C-Act K-Act 2

3
G-Act Max-Act

OK OK

Figure 6-26. Setup QC(bio) Screen Figure 6-28. QC Lot Numbers Screen

6-27
*Phone Keypad format shown.
ACTALYKE XL SIX - Setup
or Upper
Enter Lot Number Enter Lower Limit (sec)

Bksp Clear Bksp Clear

1 2 3 1 2 3

4 5 6 4 5 6

7 8 9 7 8 9

- 0 0

OK OK

Figure 6-29. Enter Lot Number Screen* Figure 6-31. Enter Lower/Upper Limit
Screen*

*QC Mean and Range* *Setup ECT*

Test: C-ACT ECT levels which 1 2 3
must pass:
Lower Upper
Level Mean
Limit Limit
Set ECT
Schedule
1

OK OK

Figure 6-30. QC Mean and Range Screen Figure 6-32. Setup ECT screen

6-28
*Phone Keypad format shown.
ACTALYKE XL SIX - Setup

*ECT Schedule* *Save/Restore/Print*

Bksp Clear Save Save Operator

Parameters IDs
Run ECT every
1 2 3
Restore Restore
hours 4 5 6 Parameters Operator IDs

7 8 9
PRINT Setup PRINT Operator
0 Parameters ID List

OK Cancel OK

Figure 6-33. ECT Schedule screen* Figure 6-35. Save/Restore/Print Screen

*Setup Automatic Output*

Make Selections for Automatic:

View Chart-------------- NO YES

Print ---------------------- None Simple Chart

Transmit----------------- NO ONE ALL

Save Patient----------- NO YES

(spreadsheet)
Save QC---------------- NO YES
(spreadsheet)
OK

Figure 6-34. Setup Automatic Output

Screen

6-29
*Phone Keypad format shown.
ACTALYKE XL SEVEN - Operating Instructions

Section 7 - Operating Instructions tion Only access, then this allows Opera-
tion Only access to the instrument.
Note: The floppy disk from the Actalyke XL
has been removed. Any functions associated (2) If the instrument has not been
with it are no longer available. setup to use any operator ID number /
password combinations, then this allows
1. If transmitting data to an external com-
Supervisor Full Rights access to the in-
puter (LIS) and/or using an optional
strument.
barcode reader, connect the LIS and/or
barcode reader to the instrument (see 4. If saving data for use on a spreadsheet,
Error! Reference source not found. and insert a floppy disk into the disk drive (see
Error! Reference source not found. for Error! Reference source not found. for
connection locations) prior to powering up disk drive location).
the instrument. 7.1. Instructions for Clotting Time Tests
2. Turn the power switch On (). 7.1.1. Run Test
3. The first displayed screen is the Enter Please refer to the activator package inserts
Operator ID screen (Figure 7-1). (Actalyke test tube: C-ACT, K-ACT, G-ACT,
a. If operator identification number / and MAX-ACT) for a detailed description of
password / security access level combina- performing an ACT clotting test.
tions have been setup for all three access The instructions for specimen collection and
levels, enter an appropriate operator ID handling and preparation of patient samples
number in the Operator ID field using the and controls, are in the appropriate sections
keypad, Bksp (backspace), and Clear keys of the procedure supplied with the tubes.
or a barcode reader. Then enter the corre-
sponding password in the Password field 1. Confirm the instrument is ready for use
using the keypad, Bksp (backspace), and by observing that the Run Test screen is
Clear keys. Use the  up and the  down displayed and that the test well tempera-
keys to move between the two fields. With tures read 37°C. If the instrument is on
the operator ID and password entered, battery power, it may have begun its bat-
press OK. tery conservation sequence and as a result
need to be reactivated. For information on
(1) If the Allow 2nd Operator for Well
the battery conservation sequence and
2 feature (section 6.2.3) is in use, the reactivating the instrument, see section
access level of the operator ID entered 7.4.2.
here determines the access level of both
operators. If the well 2 operator ID is not 2. If the Patient ID key is displayed on the
entered (section 7.5), and well 2 is used, Run Test screen (Figure 7-2), select Pa-
data generated from that well is attributed tient ID and enter the appropriate patient
to the well 1/main operator ID. information (section 7.1.1.1).
b. If either no operator IDs or no Opera- a. Depending on the selections made in
tion Only access level IDs have been setup, setup, patient information may or may not
either enter an identification number in the be required input with the run of each test
Operator ID field, using the keypad, Bksp (section 6.2.2).
(backspace), and Clear keys, or a barcode b. For the instrument to retain patient da-
reader, and select OK, or simply select OK ta, Patient ID Entry (section 6.2.2) must be
and: in use. The instrument’s maximum storage
(1) If Supervisor Full Rights and/or capacity is 25 ACT test results and 8 hepa-
Setup Access level operator IDs have been rin dosages for each of up to 15 patients. If
setup but no IDs have been given Opera- more than 25 ACT results are attributed to a
7-1
ACTALYKE XL SEVEN - Operating Instructions

patient, the first result is deleted from (2) the Results ACT chart, see sec-
memory and the most recent 25 results are tion 7.1.2 for information on using and
retained. exiting this screen.
3. Collect the patient sample according to (3) a prompt to enter the type of test
the procedure for the tube in use. run, C-ACT, K-ACT, G-ACT, or MAX-ACT.
Select the test type and the screen display
4. Open the flip top of the tube.
changes to the screen described in either
5. Dispense the required amount into the step 10.b.(1) or 10.b.(2).
tube and start the instrument's timer by
(4) a prompt to enter the patient ID,
pressing the Start key for the appropriate
see section 7.1.1.1 for instructions on using
well. When the timer begins, the Start key
and exiting this screen. The screen display
becomes an Abort key. For instructions on
changes to the screen described in
aborting a test, see section 7.2.
step 10.b.(1), 10.b.(2) or 10.b.(3).
6. Close the tube flip top and mix the tube's
c. if set to print, the printer prints at min-
contents according to the procedure.
imum: the type of test run, the number of
7. Insert the tube into the test well. the well used, and the clot time. If the
a. If the tube is not inserted into the test temperature of the test well used was out of
well within 45 seconds, the instrument range (section 9.1) when the test was run,
alerts that no tube has been detected. If the printout includes "T-" for lower than the
the tube is not inserted, the instrument low limit, or "T+" for higher than the high
repeatedly prompts until 90 seconds have limit. Additional information may print
elapsed. The instrument then automatically depending on the selections made in setup,
aborts the test and resets the well to Start. see sections 6.1.5, 6.2.2, 6.2.3, and 6.2.6.

8. Rotate the tube according to the proce- 11. On the Run Test screen, the Start/Abort
dure. The Tube status, located on the key becomes a Reset key. To run addi-
bottom left of the Run Test screen, should tional tests and reset the timer to zero,
read In for the test well in use. If the status remove the previously run test tube and
reads Out, rotate the tube clockwise to select Reset. Some keys cannot be ac-
ensure the tube is fully inserted. If Out cessed until Reset is selected. Once
remains, see section 10.2. selected, the Reset key returns to the Start
key function. (Note that if the ACT Timing
9. During a test, if the keys are available, Sequence and/or the QC/ECT Schedule
the user may select the View Chart key time intervals have elapsed while the Run
(section 7.1.2), the Patient ID key (section Test screen contains clotting time results,
7.1.1.1), or may run a test in the other test the prompt to run the required ACT and/or
well (see step 1 of this section). QC test will not appear until the timer(s) are
10. Upon clot detection, the following reset to zero.)
occurs: 7.1.1.1. Patient ID/Patient
a. the beeper sounds. Demographics
b. the screen displays one of the follow- If patient ID numbers and any patient
ing: demographics are enabled as required input
for running ACT tests, the Patient ID key will
(1) the clotting time results on the appear on the Run Test screen (Figure 7-2).
Run Test screen. The patient identification information is
entered either prior to or during a test. The
only exceptions to this is if the Patient ID

7-2
ACTALYKE XL SEVEN - Operating Instructions

Entry is set to On with ID Auto Entry Interval 1. Select Patient ID and the Patient De-
setup for use and the time interval has mographics screen (Figure 7-3) displays.
expired, or if the Patient ID Entry is set to 2. Confirm the correct well number is
Always (section 6.2.2). In either case, the indicated, and change if needed (section
patient information can be entered after the 7.1.1.1.1). Select the Patient ID & Test key
test is complete. and the Patient ID Entry/Selection screen
Once Patient ID is selected, the Patient (Figure 7-4) displays.
Demographics screen (Figure 7-3) displays. 3. To enter a patient ID either:
The following sections describe the features
on this screen. Note that any displayed a. Use an optional barcode reader (see
information for quantity of ACT points, number Error! Reference source not found. and
of times heparin has been administered, and Error! Reference source not found. for
the total heparin dosage administered are the connection location). If the input field
cumulative amounts for the patient currently contains an ID number, press Clear. Scan
indicated run on the displayed test type. in the ID and the Patient Demographics
screen displays.
7.1.1.1.1. Well Number
b. Use the keypad, Bksp (backspace),
To select the applicable well number, use the and Clear keys (Figure 7-4). The patient ID
following beginning from the Run Test screen number can contain up to 15 characters.
(Figure 7-2):
4. To select a previously entered patient ID,
1. Select Patient ID and the Patient De-
use the up  and down  keys to indicate
mographics screen (Figure 7-3) displays.
the ID number and press the Sel key.
2. Use the Well # key to indicate the well
5. To edit the patient ID number of a previ-
number to be used, 1 or 2.
ously entered patient (do not use this
3. Select one of the following: feature when the same ID number is al-
a. To enter/select a patient ID and/or ready selected for the other well as data
test type, see section 7.1.1.1.2 step 2. may be lost):

b. To select a demographic, sex, height, a. Use the up  and down  keys to

and/or weight, see step 2 of section indicate the ID number and press the Sel
7.1.1.1.3, 7.1.1.1.4, and/or 7.1.1.1.5, re- key.
spectively. b. Enter the new number using the key-
c. To delete any test data for the cur- pad, Bksp (backspace), and Clear keys.
rently displayed patient ID, see section c. Select Update.
7.1.1.1.6 step 2.
(1) If the main/well 1 operator ID in
d. To enter any heparin dosage infor- use has Setup/Supervisor access, the
mation for the currently displayed patient screen displays, "Reassign previous data
ID, see section 7.1.1.1.7 step 2. run as patient ID X to patient ID XX? No
e. To return to the Run Test screen, se- Yes." Select Yes to have the data currently
lect OK. attributed to patient ID 'X' attributed to 'XX';
otherwise, select No.
7.1.1.1.2. Patient ID & Test
(2) If the main/well 1 operator ID in
To enter, select, edit, and/or delete a patient use has Operation Only access, the opera-
ID number and/or select a test type to be run, tor cannot alter the number and the screen
use the following beginning from the Run displays, "Requires Setup Access. Previ-
Test screen (Figure 7-2): ous data run as patient ID X will be

7-3
ACTALYKE XL SEVEN - Operating Instructions

reassigned to patient XX." Touch the a. To select the other well, see section
screen to continue. 7.1.1.1.1 step 2.
(3) If the ID being changed has al- b. To select a demographic, sex, height,
ready been used and has data attributed to and/or weight, see step 2 of section
it, the screen displays, "Patient ID X al- 7.1.1.1.3, 7.1.1.1.4, and/or 7.1.1.1.5, re-
ready exists and contains Y runs. Cannot spectively.
merge with data from XX." Touch the c. To delete any test data for the cur-
screen to continue. rently displayed patient ID, see section
d. The Patient ID Entry/Selection screen 7.1.1.1.6 step 2.
displays and contains, regardless of the d. To enter any heparin dosage infor-
prompt displayed or the response selected, mation for the currently displayed patient
the altered ID. To use this number (either ID, see section 7.1.1.1.7 step 2.
as a new patient ID or as the altered ID),
proceed to step 10; otherwise, enter or e. To return to the Run Test screen
select the desired ID (see step 3 or 4, (Figure 7-2), select OK.
respectively). 7.1.1.1.3. Sex
6. To alter the demographics of a previous- If the demographic Sex is setup for use
ly entered patient, use the up  and down (section 6.2.1.4), to indicate the applicable
 keys to indicate the ID number and sex for the current patient ID, use the follow-
press Sel. Press OK to exit the screen. To ing beginning from the Run Test screen
alter the demographics displayed, see step (Figure 7-2):
2 of section 7.1.1.1.3, 7.1.1.1.4, and/or
7.1.1.1.5. 1. Select Patient ID and the Patient De-
mographics screen (Figure 7-3) displays.
7. To delete a patient ID, select the patient
ID from the list of ID numbers using the up 2. To select the applicable sex for the
 and down  keys to indicate the ID displayed patient ID, press Sex until Male
number. Press Delete Selected. The or Female displays as needed. If a differ-
screen displays, "Delete patient X (test ent patient ID needs to be entered/selected
name)? No Yes." Select Yes or No, as or the other well number selected, see step
appropriate, and the Patient ID En- 2 of section 7.1.1.1.2 or 7.1.1.1.1.
try/Selection screen displays. 3. Select one of the following:
8. To delete all patients, select Clear List. a. To select the other well, see section
The screen prompts, "Delete all patient 7.1.1.1.1 step 2.
files? No Yes." Select Yes or No, as
appropriate, and the Patient ID En- b. To enter/select a patient ID and/or
try/Selection screen displays. test type, see section 7.1.1.1.2 step 2.

9. With a patient ID entered or selected, to c. To select a demographic, height

indicate the test to be run, select Test. The and/or weight, see step 2 of section
Select Test screen displays. Select the 7.1.1.1.4 and/or 7.1.1.1.5.
appropriate test name and the Patient ID d. To delete any test data for the cur-
Entry/Selection screen displays. rently displayed patient ID, see section
10. Once all the required selections are 7.1.1.1.6 step 2.
made, select OK to return to the Patient e. To enter any heparin dosage infor-
Demographics screen (Figure 7-4) mation for the currently displayed patient
11. Select one of the following: ID, see section 7.1.1.1.7 step 2.

7-4
ACTALYKE XL SEVEN - Operating Instructions

f. To return to the Run Test screen d. To delete any test data for the cur-
(Figure 7-2), select OK. rently displayed patient ID, see section
7.1.1.1.6 step 2.
7.1.1.1.4. Height
e. To enter any heparin dosage infor-
If the demographic Height is setup for use
mation for the currently displayed patient
(section 6.2.1.4), to indicate the height for the
ID, see section 7.1.1.1.7 step 2.
current patient ID, use the following begin-
ning from the Run Test screen (Figure 7-2): f. To return to the Run Test screen
(Figure 7-2), select OK.
1. Select Patient ID and the Patient De-
mographics screen (Figure 7-3) displays. 7.1.1.1.5. Weight
2. To indicate the height for the displayed If the demographic Weight is setup for use
patient ID, press Height. If a different (section 6.2.1.4), to indicate the weight for
patient ID needs to be entered/selected or the current patient ID, use the following
the other well number selected, see step 2 beginning from the Run Test screen (Figure
of section 7.1.1.1.2 or 7.1.1.1.1. 7-2):
3. The Select Patient Height screen (Figure 1. Select Patient ID and the Patient De-
7-5) displays. mographics screen (Figure 7-3) displays.
4. Use the , , , and  keys to 2. To indicate the weight for the displayed
indicate the correct height from the list. patient ID, press Weight. If a different
The list contains heights from 0.0m to 4.0m patient ID needs to be entered/selected or
in 0.1 meter increments plus each height the other well number selected, see step 2
measurement in the equivalent feet and of section 7.1.1.1.2 or 7.1.1.1.1.
inches. 3. The Select Patient Weight screen
5. With the correct height indicated, press (Figure 7-6) displays.
Select. 4. Use the , , , and  keys to
6. With the selected height displayed in the indicate the correct weight from the list.
Current Height field, select OK. The list contains weights from 0kg to 350kg
in one-kilogram increments plus each
7. If the screen displays, "Unsaved chang-
weight measurement in the equivalent
es made. Exit anyway?" then the height
pounds.
was changed and Select was not pressed.
To exit without using the new height, select 5. With the correct weight indicated, press
Yes. To return to the Select Patient Height Select.
screen and correctly complete the selec- 6. With the selected weight displayed in the
tion, select No and repeat steps 4 and 5. Current Weight field, select from OK.
8. From the Patient Demographics screen 7. If the screen displays, "Unsaved chang-
(Figure 7-4), select one of the following: es made. Exit anyway?" then the weight
a. To select the other well, see section was changed and Select was not pressed.
7.1.1.1.1 step 2. To exit without using the new weight, select
Yes. To return to the Select Patient Weight
b. To enter/select a patient ID and/or
screen and correctly complete the selec-
test type, see section 7.1.1.1.2 step 2.
tion, select No and repeat steps 4 and 5.
c. To select a demographic, sex and/or
8. From the Patient Demographics screen
weight, see step 2 of section 7.1.1.1.3
(Figure 7-4), select one of the following:
and/or 7.1.1.1.5.

7-5
ACTALYKE XL SEVEN - Operating Instructions

a. To select the other well, see section 7.1.1.1.3, 7.1.1.1.4, and/or 7.1.1.1.5, re-
7.1.1.1.1 step 2. spectively.
b. To enter/select a patient ID and/or d. To enter any heparin dosage infor-
test type, see section 7.1.1.1.2 step 2. mation for the currently displayed patient
ID, see section 7.1.1.1.7 step 2.
c. To select a demographic, sex and/or
height, see step 2 of section 7.1.1.1.3 e. To return to the Run Test screen,
and/or 7.1.1.1.4. select OK.
d. To delete any test data for the cur- 7.1.1.1.7. Heparin Dosage
rently displayed patient ID, see section Documentation
7.1.1.1.6 step 2. Up to eight heparin dosages with the times
e. To enter any heparin dosage infor- administered per patient can be stored. This
mation for the currently displayed patient heparin dosage information will be printed,
ID, see section 7.1.1.1.7 step 2. saved and/or transmitted with the Results
ACT chart. (For an example of the printout,
f. To return to the Run Test screen
see Figure 7-9.)
(Figure 7-2), select OK.
The heparin dosage is manually entered and
7.1.1.1.6. Clear ACT Points
the instrument automatically attributes the
To delete any test data for the current time the dosage is entered as the Adminis-
patient, use the following beginning from the tered at time.
Run Test screen (Figure 7-2):
The total number of times heparin has been
1. Select Patient ID and the Patient De- administered and the total heparin dosage
mographics screen (Figure 7-3) displays. administered are displayed on the Patient
2. To delete all clotting times attributed to Demographics screen after each entry.
the displayed patient ID run on the dis- Once entered, this data cannot be alerted or
played test type, select Clear ACT Points. corrected.
If a different patient ID needs to be en- To enter a heparin dosage for the patient ID
tered/selected or the other well number in use, use the following steps beginning
selected, see step 2 of section 7.1.1.1.2 or from the Run Test screen (Figure 7-2):
7.1.1.1.1.
1. Select Patient ID and the Patient De-
3. Once Clear ACT Points is selected, the mographics screen (Figure 7-3) displays.
screen display "Delete all data for patient
2. To enter heparin dosage information for
#?" with # being the patient ID number. To
the displayed patient ID, select Heparin
exit without deleting, select No. To delete
(Figure 7-4). If a different patient ID needs
all the test results and any heparin data
to be entered/selected or the other well
attributed to the indicated patient, select
number selected, see step 2 of section
Yes.
7.1.1.1.2 or 7.1.1.1.1.
4. From the Patient Demographics screen
3. From the Heparin Dosage screen (Figure
(Figure 7-4), select one of the following:
7-7), select one of the following:
a. To select the other well, see section
a. To exit the screen without entering a
7.1.1.1.1 step 2.
heparin dosage, select Cancel.
b. To enter/select a patient ID and/or
b. To enter the dosage, use the keypad,
test type, see section 7.1.1.1.2 step 2.
Bksp (backspace), and Clear keys. With
c. To select a demographic, sex, height, the dosage entered, select OK.
and/or weight, see step 2 of section
7-6
ACTALYKE XL SEVEN - Operating Instructions

4. From the Patient Demographics screen 7.1.2. View Chart

(Figure 7-4), select one of the following: If patient ID is in use, once a patient assigned
a. To select the other well, see section to a test well has clot time data, that data can
7.1.1.1.1 step 2. be viewed and printed in chart form and/or
transmitted to an LIS. Additionally, data for all
b. To enter/select a patient ID and/or
current and stored patients can be saved to a
test type, see section 7.1.1.1.2 step 2.
floppy disk. To view any stored data, select
c. To select a demographic, sex, height, the needed patient using the instructions in
and/or weight, see step 2 of section section 7.1.1.1.2 and then the instructions in
7.1.1.1.3, 7.1.1.1.4, and/or 7.1.1.1.5, re- this section.
spectively.
To access the charted data, use the following
d. To delete any test data for the cur- steps beginning from the Run Test screen
rently displayed patient ID, see section (Figure 7-2):
7.1.1.1.6 step 2.
1. Select View Chart (Figure 7-2).
e. To return to the Run Test screen
2. If neither well contains data, the instru-
(Figure 7-2), select OK.
ment prompts, “No data to display at this
7.1.1.2. Test time.” Touch the screen, press OK, and
The test type to be run can be manually the Run Test screen returns.
entered, either prior to or during the test. 3. With a Results ACT chart (Figure 7-8)
Also, each test well contains a test tube displayed:
identification sensor to scan the barcode on
a. To view the chart for the other test
the test tubes. If the test well is unable to
well, select Well.
read the barcode and if the user did not
select the test prior to running, the instrument b. To save the data on a 3½" floppy
will prompt the user to select the test type disk, select Save.
once the test is complete. This prompt c. To print the displayed chart, select
appears similar to that discussed in step 3 of Print Chart (see Figure 7-9 for an example
this section; however, once a test type is printout).
selected, the displayed screen depends on
the selections made in setup. d. To export the displayed data to an
external computer (LIS), select Transmit.
If the test type needs to be entered and The instrument displays, “Transmit point or
patient ID is in use, see section 7.1.1.1.2 for complete curve? Single Point Complete
instructions. If patient ID is not in use, the Curve.” To transmit the last point of the
Test key is located on the Run Test screen. chart displayed when Transmit was select-
To enter the test type using this key, use the ed, select Single Point. To transmit all of
following steps beginning from the Run Test the points of the chart displayed when
screen (Figure 7-2): Transmit was selected, select Complete
Curve. Once a selection is made, the
1. Select Test (Figure 7-2).
Results ACT chart (Figure 8-4) displays.
2. The Select Test screen displays.
e. To view any clotting time result not
3. Select the correct test from the four tests currently visible in the list, use the up ▲ or
available, C-ACT, K-ACT, G-ACT, and down ▼ key. This numbered list corre-
MAX-ACT. sponds to the points plotted on the
4. The Run Test screen (Figure 7-2) dis- displayed chart. The results appear in
plays. order based on the time of completion for
each test except if both wells were simulta-
7-7
ACTALYKE XL SEVEN - Operating Instructions

neously in use for the same patient. In that ID entered and the password blank, pro-
case, the results are ordered well 1 and ceed to step 6.
then well 2 regardless of when the tests
4. Use the  up and the  down keys to
were started or concluded. This ordering
move between the Operator ID and Pass-
holds true for the plotted chart results both
word fields.
on the display and when printed.
5. Enter the corresponding password in the
f. To return to the Run Test screen
Password field (Figure 7-1) using the
(Figure 7-2), select OK.
keypad, Bksp (backspace), and Clear keys.
7.1.3. Change Operator
6. Select OK, to return to the Run Test
To access the instrument using a different screen (Figure 7-2).
operator ID, or, if the Allow a 2nd Operator
7.2. To Abort Operation
for well 2 feature (section 6.2.3) is in use, to
assign an operator to that well, follow these Once a test(s) has begun, the Start key(s)
steps beginning from the Run Test screen becomes an Abort key(s). To abort a test,
(Figure 7-2): remove the test tube from the test well and
press the Abort key for that test well.
1. Select Change Operator (Figure 7-2).
7.3. Results
2. If the Allow 2nd Operator for well 2
feature is in use, the screen displays, Refer to the procedure supplied with the ACT
"Select Main Operator or Well 2 Operator tubes for a complete discussion of Perfor-
Main Well 2." mance Characteristics.
a. To enter the ID assigned to well 1, If results on a patient show > 1500 seconds,
this ID will determine the access level for verify proper unit function by performing the
both users, select Main and see step 3. clotting time quality control verification in
section 8.1.1.
b. To enter the ID assigned to well 2,
select Well 2. The Enter Well 2 Operator If further validation of the system is required,
ID screen displays. It is used the same as several tests should be run using Actalyke
the Enter Operator ID screen described in Quality Control Materials or other commercial
steps 3 through 6, except that a saved coagulation controls, see section 8.1.2.
operator ID and password must be entered To view and print, if necessary, any clot time
even though this user will have the same data, presented in chart form, see section 7.1.2.
access/ restriction to setup as the main/well
1 operator. 7.4. Battery
3. On the Enter Operator ID screen (Figure The instrument contains a rechargeable
7-1), enter an appropriate operator ID battery (Catalog Number 5759) as a backup
number in the Operator ID field (Figure 7-1) power source. The battery used in this
using a barcode reader or keypad, Bksp instrument is a nickel metal hydride. This
(backspace), and Clear keys. type of battery does not require full discharge
prior to re-charging. Therefore, when the
a. This does not apply to Well 2 IDs: If instrument is plugged into an AC outlet and
Supervisor Full Rights and/or Setup Access the power switch is On, the battery is being
level operator IDs have been setup but no continuously recharged for one hundred
IDs have been given Operation Only ac- percent capacity at all times. If the battery
cess, any ID number entered in the becomes fully discharged, it should be
Operator ID field can gain Operation Only recharged for a minimum of eighteen hours
access to the instrument. With the operator to restore the battery to one hundred percent
capacity.
7-8
ACTALYKE XL SEVEN - Operating Instructions

7.4.1. Battery Charge down. To restart the instrument, remove the

F2 fuse, plug the power cord into an appro-
The battery charge will vary with the amount
priate AC wall outlet, and turn the power
of testing being performed. The battery
switch On. Once the instrument is on, the F2
power status is continuously displayed on the
fuse can be reinstalled. Note the battery
bottom left of the Run Test screen to allow
should be recharged for a minimum of
for easy verification of the remaining capaci-
eighteen hours to restore the battery to one
ty. When the instrument is on AC power, the
hundred percent capacity.
screen reads Charging or Charged. When
the instrument is on DC (battery) power, the 7.4.3. Battery Usage
screen reads Battery OK or Batt. LOW. If the instrument is rarely or never used on
7.4.2. Battery Conservation battery power, the battery will not maintain
maximum capacity. The sign of a less than
When the instrument is running on battery
optimal battery is when the instrument is
power, the instrument will respond by
plugged in and turned on for at least 8 hours
conserving the battery in stages based on
with the Run Test screen reading Charging
the time elapsed since the instrument’s last
(so never reads Charged).
use.
If this condition arises (or at least every 3
After ten seconds of non-use, the heaters
months), perform the Drain Battery function
turn off.
(section 10.1.6) in order to reestablish
After two minutes of non-use, the display battery performance. If this does not resolve
turns off, leaving the screen black. the problem, the battery can be replaced
After the pre-selected time interval of (section 10.1.10).
non-use has elapsed (section 6.1.8.1), the 7.5. Operator ID
instrument powers down.
If the instrument is setup to use the Operator
To continue using the instrument on battery ID timer (section 6.1.8.2) and the selected
power, touch the screen to turn on the time interval has elapsed, the screen will
heaters, reactivate the display, and/or return to the Enter Operator ID screen
restart the program depending on the (Figure 7-1). Enter the appropriate operator
current status. The test wells should be ID or operator ID / password combination
back to temperature within 1 to 3 minutes. needed to gain access to the Run Test
To provide for the needed time to rewarm screen (Figure 7-2). If the Allow 2nd Opera-
the wells, the instrument must be prevented tor for well 2 feature (section 6.2.3) is in use,
from again starting the conservation no prompt to re-enter the well 2 ID will occur.
sequence and turning off the heaters, this This prompt only applies to the main or well 1
can be accomplished by performing the operator ID. The well 2 ID must be re-
ECT test procedure described in sec- entered/changed (section 7.1.3) or the well 1
tion 8.1.1 repeatedly, as needed. ID will be attributed to both wells.
Note that if an error message is displaying 7.6. Software Installation
when the two minutes of non-use elapse,
If the option to remove all current data files
instead of the display turning off, an alarm
(step 7.b.) will be used, the currently entered
sounds. Once the error message is cleared,
information can be backed up prior to
the battery conservation timer will begin
software installation and then restored once
again if the instrument is idle.
installation is complete (section 6.4).
If on battery the instrument’s battery runs
NOTE: The software must be reinstalled by a
completely down, the screen will appear the
qualified service person using an external
same as if the instrument has powered
USB Floppy drive to perform the installation.
7-9
ACTALYKE XL SEVEN - Operating Instructions

1. Turn the instrument Off. Insert the soft- a. If data files were retained, enter the
ware upgrade floppy disk into the floppy appropriate Operator ID and Password and
disk drive located on the right side of the select OK.
instrument. Turn the instrument On. b. If data files were removed, select OK.
2. Once the software installation is com- 9. The new software is now installed.
plete, the instrument displays, "Remove disk Verify functionality (section 5.3).
from drive A:, reboot, and see Actalyke XL
Operator's Manual Software Installation 10. The new software is now ready for use.
section for further instruction." Press the See section 6 for setup instructions:
button located on the instrument's floppy a. If data files were retained, setup any
disk drive to remove the disk. new and/or altered features.
3. Turn the instrument Off, wait 10 seconds, b. If data files were removed, setup all
and turn the instrument On. The screen features, or, if the setup data was backed
displayed should contain the current soft- up to a floppy disk, restore the data (sec-
ware version. Please record this software tion 6.4.2) and then setup any new and/or
version with your instrument maintenance altered features.
records.
4. The screen may prompt for the Touch
Panel Calibration to be completed, see
section 10.1.5).
5. When the instrument displays the Tech-
nician ID screen, select OK.
6. If the instrument displays, "Error Log File
Exists. Move it to floppy? No Yes," the
user should press NO. Pressing YES will
cause the instrument display to freeze. If
YES is accidentally selected, restart the
instrument.
7. With the Run Test screen (Figure 7-2)
displayed, select Setup, Maintenance, and
Software Update. Select one of the follow-
ing:
a. To install the software and retain cur-
rent data files, select Update Only.
b. To install the software and remove
current data files, select New System. The
instrument displays, "Warning: This will
delete all data files (QC, patients, & param-
eters) and set batch files to start in normal
mode (non-maintenance). Continue? No
Yes." Select Yes.
8. Once the Enter Operator ID screen
(Figure 7-1) displays:

7-10
ACTALYKE XL SEVEN - Operating Instructions
If the Allow 2nd Operator for Well 2
feature is in use and Change Operator Once a Patient ID Number of ACT points
and then Well 2 are selected, then this is is entered, the ID attributed to the patient and
the Enter Well 2 Operator ID screen. number will display. test type displayed

* Enter Operator ID* *Patient Demographics*

Bksp Clear
Normal ACT

Operator ID Well #
Clear ACT
1 2 3 1 points 0
0123
 Patient
4 5 6 ID & Test Test: None

Password (0)
 7 8 9 Sex Male Heparin
Total
**** 0 IU

0 Height 0.0m - 0' 0"

Weight 0 kg - 0 lb
OK OK

Sex, Height, and/or Weight are Total number of times heparin and
accessible based on selections total dosage administered for the
made in setup. patient and test type displayed.
Figure 7-1. Enter Operator ID Screen* Figure 7-3. Patient Demographics Screen

or ECT Sched:, which ever This area is

has the least time blank, if
Test key, if
remaining. Time shown in Patient ID
Patient ID
hours, minutes, and Entry set
Entry set
seconds. to Off.
to Off. Input Field

QC-B Sched: 0:59:47 *RUN TEST* Change *Patient ID Entry/Selection*

Operator
Well: 1
Start 1 0333333333 Update Bksp Clear
Patient ID
445-73-0049 Test C-ACT
1 2 3
Start 2 1 0333333333 
2 0111111111 4 5 6
Patient ID 0222222222 Sel
445-73-0049 0444444444
0555555555 7 8 9
0666666666 
(1) (2) QC Patient ID
Temp(C): 37.0 37.0 - 0
Heater: OFF OFF
Tube: OUT OUT View
Setup Clear Delete
Charging Chart
List Selected
OK

or Charged or, if on Paper Feed key, if the level 1 and 2 indicate the
battery power, Battery OK of Operator ID in use is patient IDs currently
or Batt. LOW. Operation Only. assigned to each well.

Figure 7-2. Run Test Screen Figure 7-4. Patient ID Entry/Selection

Screen*

7-11
*Phone Keypad format shown.
ACTALYKE XL SEVEN - Operating Instructions

*Select Patient Height* *Heparin Dosage*


0.0m - 0' 0" Bksp Clear
Current Height 
0.1m - 0' 3"
0.2m - 0' 7"
0.0m - 0' 0" Select Enter Dosage
1 2 3
0.3m - 0' 11"
0.4m - 1' 3" 
0.5m - 1' 7"
4 5 6
 (IU)
7 8 9

OK Cancel OK

Figure 7-5. Select Patient Height Screen Figure 7-7. Heparin Dosage
Documentation Screen*

*Select Patient Weight* *Results ACT*

 Patient ID: 451

0 kg - 0 lb  Well 1 1 99  Save
1 kg - 2 lb 2 280
Select 3 350
2 kg - 4 lb

3 kg - 6 lb
4 kg - 8 lb 
Print
 
400
 Chart

 300
Current Weight

200

 100
0 kg - 0 lb 
0 Transmit
1 2 3 4 5 6 7 8 9 10

OK OK

Figure 7-6. Select Patient Weight Screen Figure 7-8. Results ACT Chart Screen

7-12
*Phone Keypad format shown.
ACTALYKE XL SEVEN - Operating Instructions

a) b)
c)
d)
e)
f)

g)

h) i)

j)

k)

l)

m)
n)
o)
p) q)

Description of printed information To include/exclude from printout, see section

a) Header 6.1.5.2
b) Printout title always included
c) Patient ID 6.2.2 & 7.1.1.1
d) Test always included
e) Operator ID currently in use 6.1.5
f) Clot time results charted always included (6.2.2, 6.2.6 & 7.1.2)
g) Clot time results listed always included
h) Operator ID that ran test 6.1.5 & 6.2.3
i) Test results outside of ACT Test Range Limits included if ACT range limits (6.2.3) in use and the
(H if above high limit and L if below low limit) test results are not within range
j) Test well temperature outside of range limits included if the temperature of the test well used
(T+ if above high limit and T- if below low limit) was not within range (9.1)
k) Heparin Documentation 6.2.2 & 7.1.1.1
l) Patient Demographics 6.2.2 & 7.1.1.1
m) Instrument Serial Number 6.1.5
n) Date printed 6.1.5
o) Time printed 6.1.5
p) ACT Test Range Limits 6.2.3
q) Footer 6.1.5.2

Figure 7-9. Results ACT Chart Printout

7-13
ACTALYKE XL EIGHT - Test Functions and Quality Control

Section 8 - Test Functions and Quality 3. The instrument displays, “Select Well for
Control QC ECT: Well #1 Well #2 Cancel.”
Select one of the following:
Note: The floppy disk from the Actalyke XL
has been removed. Any functions associated a. Select Cancel and then OK to return
with it are no longer available. to the Run Test screen (Figure 8-1).
Routine quality control testing and tracking b. Select Well #1 or Well #2 for the de-
should be part of a comprehensive quality sired test well and proceed to step 4.
assurance program. Quality Control prod- 4. From the displayed options, 100 sec-
ucts are available for routine Actalyke tests. onds, 300 seconds and 500 seconds,
8.1. QC select the same time as the time set on the
ECT (see the ECT instructions for infor-
The instrument automatically performs a
mation on setting the time).
self-test any time the power is turned On.
Should an error message appear on the 5. Turn the ECT On (see the ECT instruc-
display, see section 10.2. tions for information on turning On the
ECT), and simultaneously press the Start
Entering and Exiting the QC Mode
key for the appropriate test well.
The QC mode can be manually entered at
6. Insert the ECT into the appropriate test
any time by selecting the QC key on the Run
well.
Test screen, and then, by making a selection
from the QC OPTIONS screen (Figure 8-2). 7. When the test is complete, depending on
selections made in setup, the results are
When the QC mode is manually entered and
printed and/or the screen displays either
when no tests are run, the QC mode is
the time on the Run Test screen (Figure
manually exited by selecting the Patient key.
8-1) or the Levey-Jennings chart (Figure
The QC mode is automatically entered, when 8-4). (See section 8.1.3 for information on
QC(bio) Schedule and QC(bio) Levels Which the Levey-Jennings chart.)
Must Pass and/or ECT Schedule and ECT
8. From the Run Test screen (Figure 8-1),
Levels Which Must Pass are in use, once a
remove the ECT and press Reset to reset
selected schedule time elapses. At that time,
the timer to zero and allow additional tests
the test or tests required must be run.
to be run. (Note: If the Run Test screen
When a biological QC and/or ECT test is run contains time results when the time interval
and the well(s) used reset (and, if in use, any between QC/ECT tests elapses, the prompt
Levels Which Must Pass requirements are to run the next QC/ECT test will not display.
complete), the instrument automatically exits Once the timer(s) is reset to zero, the
the QC mode. prompt will display. For ACT tests, in
8.1.1. Run ECT Self Check (Clotting addition to the timer being reset to zero, the
Time Check) instrument must be out of the QC mode for
the prompt to run the next ACT test to
The Actalyke Electronic Clotting Tube (ECT), display.)
Catalog Number XL-ECT, is available for
verification of clotting time. Follow the 9. Repeat steps for the other test well.
instructions provided in the ECT package 10. Once complete, remove the ECT from
insert and the following steps beginning from the well and store it in the tube provided
the Run Test screen (Figure 8-1): with the ECT.
1. Select QC (Figure 8-1).
2. Select Run ECT Self Check (Figure 8-2).

8-1
ACTALYKE XL EIGHT - Test Functions and Quality Control

8.1.2. Run Biological QC Test (QC of 1. Select QC (Figure 8-1).

Individual Coagulation Assays) 2. Select Run Biological QC Test (Figure
Each box of Actalyke Activated Clotting Time 8-2).
tubes contains 50 tubes from a single 3. From the QC (Biological) screen (Figure
manufactured lot. Before use, perform a 8-3), select Change Test for the test well to
verification test one time with the appropriate be used.
Actalyke QC Kit. Perform this test on one
box of each lot, each time a shipment of 4. From the displayed choices of C-ACT,
tubes is received. Acceptable ranges for the K-ACT, G-ACT, and MAX-ACT, select the
various Actalyke coagulation assays are test being performed and the screen re-
included in the appropriate Quality Control turns to the QC (Biological) screen (Figure
procedure. Biological QC tests should then 8-3).
be performed at least weekly to verify system 5. For the test well being used, select 1, 2
function. or 3 for the level of the test being run.
The range limits and lot numbers can be 6. Biological QC tests can be run on both
entered either using the instrument’s touch wells simultaneously, so if a test and a level
screen (section 6.2.4.3) or, from the Run need to be selected for the other well, see
Test screen, using an optional barcode step 3. If all the needed selections have
reader to scan the QC test barcode labels been made, see step 7.
included with the QC tests. Range limits
must be entered before tests can be run. 7. Select OK until the screen returns to the
Run Test screen (Figure 8-1).
If the barcode reader is used, when the
barcode label is scanned, the instrument 8. Follow the procedure for preparing the
confirms the scanned test information QC test. Unless directed to do otherwise,
matches the currently entered data. (See press the Start key for the appropriate test
Error! Reference source not found. and well(s) at the same time the test tube(s) is
Error! Reference source not found. for prepared. Insert the test tube(s) into the
barcode reader connection location.) If the appropriate test well(s).
test information is different and the main
9. When the test is complete, depending on
operator ID in use has a Supervisor Full
selections made in setup, the results are
Rights or Setup Access access level, the
instrument prompts the operator, “Do you printed and/or the screen displays either the
wish to backup the previous QC lot data? time on the Run Test screen (Figure 8-1) or
No Yes Cancel.” To cancel without the Levey-Jennings chart (Figure 8-4). If the
altering the test information, select Cancel. test was run in well 2, the Levey-Jennings
To backup the data, confirm a floppy disk is chart must be manually accessed, if need-
in the disk drive and select Yes. To continue ed. (See section 8.1.3 for information on the
without backing up the data, select No. With Levey-Jennings chart.)
a selection made (and the data backed up, if 10. From the Run Test screen (Figure 8-1),
selected) the new test information, lot remove the test tube and press Reset to
number and ranges, are entered. Note that reset the timer to zero and allow additional
QC ranges and lot numbers cannot be tests to be run. (Note: If the Run Test
entered by operators with Operation Only screen contains time results when the time
access. interval between QC/ECT tests elapses,
To perform the biological QC test, see the the prompt to run the next QC/ECT test will
procedure supplied with the QC tests for not display. Once the timer(s) is reset to
instructions and follow these steps beginning zero, the prompt will display. For ACT
from the Run Test screen (Figure 8-1): tests, in addition to the timer being reset to

8-2
ACTALYKE XL EIGHT - Test Functions and Quality Control

zero, the instrument must be out of the QC 10. To return to the Run Test screen
mode for the prompt to run the next ACT (Figure 8-1), select OK until the Run Test
test to display.) screen appears.
8.1.3. View/Output View Chart 8.1.4. Delete Complete QC Test Data
(Levey-Jennings Chart) The data generated from one test well for a
The Levey-Jennings Chart’s maximum specific QC test cad be deleted. Note that
storage capacity is 200 points of QC clot operator IDs with Operation Only access
times per QC test type and level. cannot delete data. Additionally note that if QC
data is saved to a floppy disk for use on a
To view, save, transmit and/or print a
spreadsheet, and the same disk is used
Levey-Jennings Chart, either press View
repeatedly, the data will also be deleted from
Chart from the Run Test screen (Figure 8-1)
that file the next time data is saved. To prevent
and see step 3, or use the following steps
this, a new floppy disk must be used. To delete
beginning from the Run Test screen:
data, use the following steps beginning from
1. Select QC (Figure 8-1). the Run Test screen (Figure 8-1):
2. Select View/Output (Figure 8-2). 1. Select QC (Figure 8-1).
3. The Levey-Jennings Chart (Figure 8-4) 2. Select Delete Complete QC Test Data
displays the test results for the test type (Figure 8-2).
currently selected for well 1.
3. The instrument displays, "Select Well for
4. To view a different test’s chart, select QC ECT: Well #1 Well #2." Select the
Test and on the screen displayed select appropriate well number.
from C-ACT, K-ACT, G-ACT, MAX-ACT, or
4. The instrument displays, “All QC clotting
ECT.
times for all levels of the selected test will
5. To view the data generated on the other be deleted. C-ACT K-ACT G-ACT
test well, select Well. MAX-ACT ECT Cancel.” Select one of
6. If the currently displayed chart contains the following:
more data points than can be displayed at a. To return to the QC Options screen
once, use the Previous Page and/or Next (Figure 8-2) without deleting any QC data,
Page keys to view the remaining data. select Cancel.
7. To save the data on a 3½" floppy disk, b. To delete all the QC data for the se-
select Save. lected test type, select C-ACT, K-ACT,
8. To print the chart, select Print Chart (see G-ACT, MAX-ACT, or ECT. The data for
Figure 8-5 for an example printout). that test is deleted and the screen returns
to the QC Options screen (Figure 8-2).
9. To export the data to an external com-
puter (LIS), select Transmit. The 5. To return to the Run Test screen (Figure
instrument displays, “Transmit point or 8-1), select OK.
complete curve? Single Point Complete 8.1.5. Delete Single QC Clot Point
Curve”. To transmit the last point of the
A clot point from a specific QC test level can
chart displayed when Transmit was select-
be deleted. Note that operator IDs with
ed, select Single Point. To transmit all of
Operation Only access cannot delete data.
the points of the chart displayed when
Additionally note that if QC data is saved to a
Transmit was selected, select Complete
floppy disk for use on a spreadsheet, and the
Curve. Once a selection is made, the
same disk is used repeatedly, the data will also
Levey-Jennings Chart (Figure 8-4) dis-
be deleted from that file the next time data is
plays.
8-3
ACTALYKE XL EIGHT - Test Functions and Quality Control

saved. To prevent this, a new floppy disk must (2) To return to the QC Point Dele-
be used. To delete a specific data point, use tion screen without removing the clot point,
the following steps beginning from the Run select No.
Test screen (Figure 8-1): 12. To return to the Run Test screen
1. Select QC (Figure 8-1). (Figure 8-1), select OK until the Run Test
screen displays.
2. Select Delete Single QC Clot Point
(Figure 8-2). 8.1.6. Temperature QC (Test Well
Temperature Check)
3. The instrument displays, “Select test
C-ACT K-ACT G-ACT MAX-ACT ECT 1. If using an Actalyke Thermometer,
Cancel.” Select one of the following steps: Catalog Number 5757, to perform tempera-
ture checks of the test wells, refer to the
a. To return to the QC Options screen
installation instructions included with the
(Figure 8-2) without deleting any QC data,
Actalyke Thermometer. Then proceed to
select Cancel, see step 6.
step 5.
b. Select C-ACT, K-ACT, G-ACT,
2. To use a different temperature-sensing
MAX-ACT, or ECT to access the desired
device, the device must have a minimum
QC test data. See step 4.
accuracy at 37°C of ± 0.2°C. Also needed
4. The QC Point Deletion screen (Figure are an empty glass test tube (100 mm long
8-6) displays. x 13 mm diameter) and 1 mL of water.
5. To change the test type displayed, select 3. Fill the test tube with the water and place
Test. From the Select Test screen, select the test tube into a test well. Allow the test
the test type. The QC Point Deletion tube to equilibrate for a minimum of five
screen displays. minutes.
6. To change the well number, select Well. 4. Place the temperature-sensing device
7. To change the level displayed, press into the water filled test tube. Allow the
Level until the correct level number dis- device to stabilize for three minutes and
plays, 1, 2, or 3. note the temperature registered.

8. If no data exists for a test, well, and 5. The temperature should remain in a
level, an error message displays. Touch range of 36.5 to 37.5°C. If the temperature
the screen to remove the prompt and press exceeds this range, see section 10.2.
Test, Well, or Level to access a different 6. Repeat steps for the other test well.
list.
9. To indicate the clot point to be deleted,
use the up  and down  keys.
10. If needed, use the Previous Page and
Next Page keys to view any clot points not
currently displayed.
11. With the correct data point indicated,
select the Delete key. The prompt, “Delete
the selected QC data point? No Yes”
displays.
(1) To remove the point, select Yes
and the QC Point Deletion screen returns.

8-4
ACTALYKE XL EIGHT - Test Functions and Quality Control
or ECT Sched:, which ECT for ECT QC or
ever has the least time QC(bio) for Biological
remaining. Time shown QC. 1, 2 or 3 depending
in hours, minutes, and on the test level Indicates test type in use.
seconds. selected.

QC-B Sched: 0:45:15 *RUN TEST* Change *QC (Biological)*

Operator

Start 1
QC(bio) Well 1 C-ACT Level
1
Change Test 1 2 3
Start 2
ECT
1 Well 2 ECT Level
Change Test 1 2 3
(1) (2) QC Patient
Temp(C): 37.0 37.0
Heater: OFF OFF
Tube: OUT OUT
View
Charging Chart Setup
OK

or Charged or if on Paper Feed key, if the level of

battery power Battery Operator ID in use is
OK or Batt. LOW. Operation Only.

Figure 8-1. Run Test (QC mode) Screen Figure 8-3. QC Biological Screen

*QC OPTIONS* *Levey - Jennings Chart*

Test C-ACT Well 1 Save
Run ECT Self
Check
Delete Complete Previous Page Next Page
QC Test Data
Run Biological
QC Test 3 
2  Print
3
Delete Single QC 1 
3 3 1 3 Chart
Clot Point 0 
1 1
View/Output 1
-1 
-2 
-3 
Transmit

1 - 02/26/02 8:03 am
8 - 07/26/03 10:11 am OK
OK

Figure 8-2. QC Options Screen Figure 8-4. Levey-Jennings Chart Screen

8-5
ACTALYKE XL EIGHT - Test Functions and Quality Control

e) f) g) h) i)
a)
d)
b)
c)
Description of printed information
j) a) Header
b) Printout Title
c) Test
d) Well number
e) Level
f) Lot numbers
l) m) g) Mean
k) h) Standard Deviation
i) Quantity of tests run for each level
n) j) QC result time charted
k) Test date (if the date format in use is greater
o) than six digits, then the date appears in the
six-digit format closest to the selected format)
p) l) Operator ID (if the ID is greater than five digits,
then only the first five digits of the ID appear)
q)
m) Time results
r) n) Standard Deviation Index
o) Serial Number
p) Date
q) Time
r) Footer
Figure 8-5. Levey-Jennings Chart
Printout

*QC Point Deletion*

Test C-ACT Well 1 Level 1

Previous Page Next Page 

1 12/15/06 08:03 AM 138 sec

2 12/16/06 08:47 AM 129 sec 

3 12/18/06 08:22 AM 148 sec

4 12/19/06 09:09 AM 129 sec

Delete

OK

Figure 8-6. QC Point Deletion Screen

8-6
ACTALYKE XL NINE - Performance Specifications

Section 9 - Performance Specifications Material: Borosilicate glass or plastic

Style: Round Bottom or Flat Bottom
9.1. Instrument Performance
Label: (for operator identification and tracking)
Specifications Test Type: Activator type.
Note: The floppy disk from the Actalyke XL Lot No.: Activator lot number.
has been removed. Any functions associated Exp.: Expiration date of tubes.
with it are no longer available. 9.2. System Performance Characteristics
Measurement Range: 90-1500 seconds 9.2.1. MAX-ACT
Incubation Temperature: 36.5°C - 37.5°C REFERENCE RANGES
Dimensions: width x height x length MAX-ACT test tubes were run on normal
10.7” x 8.0” x 12.0” healthy patients using multiple Actalyke
Weight (with printer): 15 pounds (Models XL, A2P and MINI) and Hemochron®
Instruments (Model 8000). Quality control
Line Voltage: 50 - 60 Hz, 110 - 220 V A/C tests were performed on each instrument
Power (watts): ~ 220 prior to testing of Actalyke tubes for this
study. The results were as follows:
Leakage Current - Less than 100 A
N Mean 2SD Reference Range
Two fuses located on the back panel. Only Actalyke XL 66 118 17 100-136 seconds
replace with equivalent fuses. Actalyke MINI 49 115 18 97-133 seconds
Instrument Operating Environment: Actalyke A2P 49 117 22 98-136 seconds
Hemochron 112 17 95-129 seconds
Ambient Temperature Range -
15°C to 30°C (59 to 86°F) Mean data from each patient was used to establish the
Operating Relative Humidity - mean ± 2SD normal range.
10% to 80%, non-condensing
Altitude 2000 M PERFORMANCE CHARACTERISTICS

The features of the Actalyke System include: Clinical Data Performance

Testing at point-of-care or laboratory. Studies were also conducted clinically at
Uses fresh whole blood. numerous institutions. A total of 330 paired
Test results within minutes. blood samples were collected from patients
Fully portable system. (including adult bypass, pediatric bypass,
Test wells automatically incubated to 37°C and cardiac catherization) before, during,
(+ 0.5°C). and following heparinization.
Equipment protected throughout by double
insulation or reinforced insulation (equivalent Using a reference celite-based ACT test
to Class I of Low Voltage Directive (FTCA510/C-ACT) in CPB patients, the data
72/23/EEC). yielded a correlation coefficient of r2 = 0.82
Pollution degree 2 and r2 = 0.89 when samples from the
Microprocessor controlled for enhanced reliabil- reference group were omitted which were
ity and reporting of fault conditions. outside the published linear range (0-600
LCD 3.2” x 4” for easy readability. seconds) for the reference tube.
Printer for hard copy recording of test results.
Results obtained using a reference kaolin-
3½” floppy disk drive for archiving results.
based ACT test (ACTII/K-ACT/FTKACT)
Test Tube: were compared to those obtained using
Dimensions: MAX-ACT test tubes, and the data yielded a
Length - 100 mm correlation coefficient of r2 = 0.89.
External Diameter - 13 mm

9-1
 ACTALYKE XL NINE - Performance Specifications

Correlation Data Actalyke XL

The Actalyke XL and the MINI were com- The precision of the MAX-ACT tubes with the
pared to the Actalyke using MAX-ACT tubes. Actalyke XL ACT system was evaluated by
The data was as follows: performing multiple replicates on twenty
MINI n=166 Y=0.995X - 4 r=0.989 separate days with heparinized and non-
XL n=104 Y=0.983X + 2.7 r=0.985 heparinized Actalyke Whole Blood Control
samples, levels I and III.
Heparin Sensitivity Level I III
Mean 126.3 402.2
Heparin response was determined with SD 4.5 25.4
multiple heparin concentrations added to the %CV 3.5 6.3
blood of normal donors. Curves were
generated using the mean of the pooled data 9.2.2. C-ACT, K-ACT and G-ACT
from 5 donors (r values are >0.99) yielding REFERENCE RANGES
the following results.
Actalyke ACT test tubes were run on
MAX-ACT Heparin Response Actalyke instruments (Model A2P, MINI and
XL) and Hemochron Instrument (Model
8000). Quality control tests were performed
on each instrument prior to testing of
Actalyke tubes for this study. Each tube type
ACT (seconds)

was run with normal volunteers on each

instrument. The results are as follows:
Test Instrument N Mean 2SD Reference Range
C-ACT Actalyke 30 123 26 97-149 seconds
Actalyke MINI 30 123 29 94-152 seconds
Actalyke XL 66 126 21 105-148 seconds
Hemochron 15 126 15 111-141 seconds
u/ml Heparin
K-ACT Actalyke 35 123 28 93-150 seconds
Actalyke MINI 35 125 25 100-150 seconds
Heparin Linearity Actalyke XL 64 132 21 102-153 seconds
Hemochron 15 129 23 106-152 seconds
Linearity studies were done according to G-ACT Actalyke 44 185 38 147-223 seconds
NCCLS EP-6 guidelines. The MAX-ACT Actalyke MINI 44 181 34 147-215 seconds
Actalyke XL 63 189 42 147-233 seconds
demonstrated an upper linearity limit of 6 Hemochron 15 167 20 147-187 seconds
units of heparin per milliliter of patient blood.
Precision Data PERFORMANCE CHARACTERISTICS
All precision studies were done according to Precision Studies
NCCLS EP-5 guidelines. All precision studies were done according to
Actalyke MINI NCCLS EP-5 guidelines.
The precision of the MAX-ACT tubes with the Actalyke MINI
Actalyke Mini ACT system was evaluated by The precision of the Actalyke Activated
performing multiple replicates on twenty Clotting Time Test System was evaluated by
separate days with heparinized and non- performing multiple replicates on twenty
heparinized Actalyke Whole Blood Control separate days with heparinized and non-
samples, levels I and III. heparinized Actalyke Whole Blood Control
Level I III samples. C-ACT and K-ACT tests were run
mean 125.5 401.9 with levels I and III; G-ACT with levels I and
SD 3.57 23.54 II. The coefficient of variation for each test
%CV 2.8 5.9 type was less than 10%.
9-2
ACTALYKE XL NINE - Performance Specifications

C-ACT K-ACT G-ACT Kaolin Response to Heparin

Level I III I III I II
mean 127.0 388.2 125.1 389.9 146.8 286.3
sd 4.60 18.44 4.97 16.40 6.76 16.37
% cv 3.6 4.8 4.0 4.2 4.6 5.7

ACT (seconds)
Actalyke XL
The precision of the Actalyke Activated
Clotting Time Test System was evaluated by
performing multiple replicates on twenty
separate days with heparinized and non-
heparinized Actalyke Whole Blood Control
u/ml Heparin
samples. C-ACT and K-ACT tests were run
with levels I and III; G-ACT with levels I and Glass Beads Response to Heparin
II. The coefficient of variation for each test
type was less than 10%.
C-ACT K-ACT G-ACT

ACT (seconds)
Level I III I III I II
mean 131.9 395.3 128.7 398.6 145.7 282.9
sd 6.3 15.3 4.6 16.7 16.7 15.8
% cv 4.8 3.9 3.6 4.2 4.2 5.6

Accuracy Data
The accuracy of the Actalyke Activated u/ml Heparin
Clotting Time Test System was evaluated by
performing multiple Activated Clotting Time Key to Graphs
tests using varied combinations of instru-
Instrument / Tube
ments and tubes. Citrated pooled blood was A-A* = Actalyke / Actalyke
M-A* = MINI / Actalyke
heparinized to create the below concentra- XL-A* = Actalyke XL / Actalyke
tions yielding the following results: H-H = Hemochron / Hemochron
H-A = Hemochron / Actalyke
A-H = Actalyke / Hemochron
Heparin Sensitivity A-A = Actalyke / Actalyke
*run with different set of donors
Celite Response to Heparin
Correlation Data
Patient samples from all clinical sites were
tested using each tube type on the MINI, the
ACT (seconds)

XL and the Actalyke. The data was as follows.

C-ACT MINI n=84 Y=0.948X + 15 r=0.979
XL n=104 Y=0.943X + 11.7 r=0.960
G-ACT MINI n=97 Y=0.967X + 2 r=0.979
XL n=92 Y=0.998X - 3.0 r=0.985
K-ACT MINI n=90 Y=0.984X + 10 r=0.966
XL n=97 Y=0.978X + 6.9 r=0.988
u/ml Heparin

Linearity
Linearity studies were done according to
NCCLS EP-6 guidelines with the following
results.
C-ACT K-ACT G-ACT
Heparin u/mL blood 5.0 5.0 2.0

9-3
ACTALYKE XL TEN - Maintenance, Troubleshooting, Warranty

Section 10 - Maintenance, Allow the instrument to cool, if necessary.

Troubleshooting, Warranty Dampen a lint-free tissue with deionized
water and wash the surface of the unit.
Note: The floppy disk from the Actalyke XL
Should an instrument be contaminated by
has been removed. Any functions associated
blood or blood derivative, clean the area
with it are no longer available.
contaminated with a commercial virucidal
10.1. Maintenance and germicidal agent.
This section describes routine operator Clean spills with a soft cloth or sponge. Do
maintenance procedures. For instrument not use corrosive or abrasive cleansers. Dry
calibration or for maintenance not described the unit before plugging in the power cord or
in this manual, call Helena Laboratories for turning on the power switch.
assistance.
10.1.2. Clotting Time Check
WARNING: ACTALYKE XL is factory
The Actalyke Electronic Clotting Tube (ECT),
lubricated. Do NOT lubricate instrument.
Catalog Number XL-ECT, is available for
Table 10-1. Maintenance Schedule verification of clotting time. Follow the
instructions provided in the ECT package
Daily, if Used
Clean the Instrument
insert and the following steps beginning from
Clotting Time Check (ECT) the Run Test screen (Figure 8-1):
Weekly 1. Select QC (Figure 8-1).
Test Well Temperature Check
Monthly 2. Select Run ECT Self Check (Figure 8-2).
Clean the Test Wells 3. The instrument displays, "Select Well for
Quarterly QC ECT: Well #1 Well #2 Cancel."
Drain Battery
Touch Panel Calibration Select one of the following:
As Needed a. Select Cancel and OK to return to the
Replace Printer Paper Run Test screen (Figure 8-1).
Fuse Replacement
Mag Sensor Calibration b. Select Well #1 or Well #2 for the de-
Replace Battery sired test well and proceed to step 4.

Should any technical difficulties arise, it is 4. From the displayed options, 100 sec-
recommended that multiple tests be run with onds, 300 seconds and 500 seconds,
Biological Quality Control kits (section 8.1.2) select the same time as the time set on the
and an Electronic Clotting Tube (section ECT (see the ECT instructions for infor-
10.1.2). Results can then be discussed with mation on setting the time).
Helena Laboratories Technical Services 5. Turn the ECT On (see the ECT instruc-
Department. tions for information on turning On the
In cases where quality control results fall ECT), and simultaneously press the Start
outside the acceptable range, patient results key for the appropriate test well.
should be considered suspect. The cause 6. Insert the ECT into the appropriate well.
will likely be test technique, control material,
7. When the test is complete, the results
instrument, or the coagulation test tube, see
are printed, and the screen displays, either
section 10.2.
the time on the Run Test screen (Figure
10.1.1. Instrument Cleaning 8-1) or the Levey-Jennings chart (Figure
TURN OFF THE POWER AND UNPLUG 8-4), depending on selections made in
POWER CORD BEFORE PROCEEDING. setup. (See section 8.1.3 for information
on the Levey-Jennings chart.)
10-1
ACTALYKE XL TEN - Maintenance, Troubleshooting, Warranty

8. From the Run Test screen (Figure 8-1), Allow the instrument to cool, if necessary. If
remove the ECT and press Reset to reset there is an obstruction in the test well(s),
the timer to zero and allow additional tests carefully tilt the instrument forward and allow
to be run. (Note: If the Run Test screen the obstruction to fall out. Take care when
contains time results when the time interval handling the obstruction in the event it has
between QC/ECT tests elapses, the prompt sharp edges and/or is a biohazard. Dispose
to run the next QC/ECT test will not display. of the obstruction as necessary.
Once the timer(s) is reset to zero, the If there is liquid in the test well, assume that
prompt will display. For ACT tests, in the test well is contaminated. Clean the area
addition to the timer being reset to zero, the with a commercial virucidal and germicidal
instrument must be out of the QC mode for agent. Using a lint-free tissue and a cotton
the prompt to run the next ACT test to swab, wipe up the residue, as these materi-
display.) als may contain alcohol, which is corrosive to
9. Repeat steps for the other test well. metal surfaces. Dry the unit before plugging
in the power cord or turning On the power
10. Once complete, remove the ECT from
switch.
the well and store it in the tube provided
with the ECT. 10.1.5. Touch Panel Calibration
10.1.3. Test Well Temperature Check To calibrate the touch screen, use the
following steps beginning from the Run Test
1. If using an Actalyke Thermometer,
screen (Figure 6-2):
Catalog Number 5757, to perform tempera-
ture checks of the test wells, refer to the 1. Select Setup (Figure 6-2).
installation instructions included with the 2. Select Maintenance (Figure 6-3).
Actalyke Thermometer. Then proceed to
step 5. 3. From the Maintenance screen, select
Touch Panel Calibration.
2. To use a different temperature-sensing
device, the device must have a minimum 4. The Touch Panel Calibration screen
accuracy at 37°C of + 0.2°C. Also needed displays and prompts, "Touch upper left
are an empty glass test tube (100 mm long corner." Touch the upper left corner of the
x 13 mm diameter) and 1 mL of water. screen with the end of a retracted ballpoint
pen or mechanical pencil.
3. Fill the test tube with the water and place
the test tube into a test well. Allow the test 5. Follow the other prompts to touch the
tube to equilibrate for a minimum of five screen in the upper right, lower left and
minutes. lower right corners of the screen.
4. Place the temperature-sensing device 6. Once complete, the Maintenance screen
into the water filled test tube. Allow the displays.
device to stabilize for three minutes and 7. To return to the Run Test screen, select
note the temperature registered. OK until the Run Test screen displays.
5. The temperature should remain in a 10.1.6. Drain Battery
range of 36.5 to 37.5°C. If the temperature
exceeds this range, see section 10.2. To maintain the battery at maximum capaci-
ty, perform the battery drain function every
6. Repeat steps for the other test well. three months or as needed. The battery
10.1.4. Test Well Cleaning drain function needs to be performed when
the instrument has been plugged in and
TURN OFF THE POWER AND UNPLUG turned on for 8 hours and still reads Charg-
POWER CORD BEFORE PROCEEDING.

10-2
ACTALYKE XL TEN - Maintenance, Troubleshooting, Warranty

ing. Use the following steps beginning from battery may need to be replaced (section
the Run Test screen (Figure 6-2): 10.1.10).
1. Unplug the instrument and verify the 10.1.7. Printer Paper Replacement
bottom left of the Run Test screen, reads 1. Unwrap a new printer paper roll.
Battery OK or Batt. Low.
2. Remove the empty paper roll and the
2. Select Setup (Figure 6-2). paper retainer ( and Error! Reference
3. Select Maintenance (Figure 6-3). source not found.).
4. From the Maintenance screen, select 3. Ensure that the new paper roll has a
Drain Battery. tapered, sharp, even leading edge.
5. The Draining Battery for Cycling screen 4. Place the new paper roll in the instru-
displays and includes the Battery State and ment with the paper feeding off the bottom
Power: DC. Note that if Power instead of the roll.
reads AC, unplug the instrument. 5. Insert the leading edge of the paper into
6. Leave the instrument unplugged and On the back slot. It may be necessary to
overnight or until the instrument automati- adjust the printer assembly’s serrated
cally shuts down. plates position using the two silver screws.
7. Once the instrument has shut down, plug 6. Use the Paper Feed key (section 6.3) to
the instrument in and then touch the advance the new paper.
screen, in that order. Within five seconds, 7. If the serrated plate’s position was
the instrument should restart. altered, reposition the plate to allow for
a. If it does not restart, turn the instru- ease of paper/printout removal.
ment Off, wait 10 seconds, and turn the 8. Insert the paper retainer, over the paper
instrument On. roll, securing it between the sides of the
b. If the instrument again does not re- paper roll housing.
start, turn the instrument Off, remove the 10.1.8. Fuse Replacement
F2 fuse located on the rear of the instru-
ment, turn the instrument On, and replace 1. Turn Off the power and unplug the power
the F2 fuse. cord.
c. If the instrument again does not re- 2. Using a small flathead screwdriver,
start, the battery must be replaced which matches the slot in the fuse holder,
(section 10.1.10). press inward and turn the fuse holder
counterclockwise to remove the fuse holder
8. When the Enter Operator ID screen ().
displays, enter the appropriate Operator ID
and password, and select OK. The Run 3. Remove the blown fuse and replace it
Test screen displays and the bottom left of with one of the same type and rating.
the screen reads Charging. 4. Push the fuse holder in and turn clock-
9. Recharge the battery for a minimum of wise, with the screwdriver, to reseat the
eighteen hours by leaving the instrument fuse.
plugged in and turned On. 5. Repeat for the other fuse as necessary.
10. Once the battery drain and recharge 6. Plug in the power cord and turn On the
steps are complete, the Run Test screen power. If the fuse immediately blows
should read Charged when the instrument again, call Helena Laboratories for assis-
is plugged in and turned On. If not, the tance.

10-3
ACTALYKE XL TEN - Maintenance, Troubleshooting, Warranty

10.1.9. Mag Sensor Calibration b. If the calibration failed, an error mes-

sage displays. Record the error message,
If the test wells are not accurately detecting
and repeat the calibration beginning with
the presence of tubes, the test wells can be
step 2. If the calibration fails for a second
calibrated. Two ECTs are required to
time, with the two error messages noted,
perform the calibration. Use the following
call Helena Laboratories.
steps beginning from the Run Test screen
(Figure 6-2): 8. From the Maintenance screen, select OK
until the Run Test screen displays.
1. Select Setup (Figure 6-2).
Note that if calibration is performed while on
2. Select Maintenance (Figure 6-3).
battery power and the instrument powers off
3. From the Maintenance screen, select during the calibration, the calibration must be
Mag Sensor Calibration. redone using AC power or with a recharged
4. The screen displays the prompt, "Please battery.
remove all tubes from wells" and two 10.1.10. Battery Replacement
options, "Cancel" and "Continue."
To replace the battery, use the Actalyke XL
a. To return to the Maintenance screen, Battery Pack, Catalog Number 5759.
select Cancel (see step 8). Additional materials needed are 1/4” nut
b. To calibrate the test wells, remove driver, 1/4” open end wrench, and small
any tubes from the test wells and select flathead screwdriver. This procedure should
Continue. only be performed by trained electronics
personnel. All directional instructions given
5. The screen prompts, "Please insert assume the unit’s control panel is facing
calibration tubes or ECT devices (Unset) in forward toward the installer. See Figure 10-1
BOTH wells" and two options, "Cancel" and for additional assistance.
"Continue." Calibration tubes are only for
use by Helena Service Department. 1. Remove the printer paper from the
printer. Turn the unit’s power Off and
a. To return to the Maintenance screen, unplug the power cord prior to beginning
select Cancel (see step 8). installation.
b. To calibrate the test wells, without ac- 2. The unit's TOP COVER is removed
tivating the triggers, insert an ECT into using the LID KEY to release the four
each test well and select Continue. locating tabs. Four sets of slots located on
6. The screen displays the prompt, "This the left and right panels of the unit provide
procedure should take approx. 2 minutes. access to the locating tabs.
Please wait." Beginning from the set of slots forward on
a. To abort the procedure, touch the the left panel of the unit and going clockwise
screen and the Maintenance screen dis- around the unit, push the blade of the lid key
plays (see step 8). into one slot per set of slots as instructed:
In the left forward set, use the BOTTOM
7. When the calibration is complete, the slot.
screen displays the prompt, "Please RE- In the left rear set, use the TOP slot.
MOVE calibration tubes. Touch the screen In the right rear set, use the BOTTOM slot.
to continue." Remove the ECTs and touch In the right forward set, use the TOP slot.
the screen.
Note that the lid key does not and should not
a. If the calibration was successful, the be turned in the slots. The release of the
Maintenance screen displays (see step 8). locating tabs is "silent" and will not be heard
or felt.
10-4
ACTALYKE XL TEN - Maintenance, Troubleshooting, Warranty

Holding each side of the top cover, slowly lift battery's connector should face the rear of
upwards, taking care not to damage the two the unit.
connections attached to the cover. One of 9. Use the nut driver to secure the stand-
which, the gray printer cable connected to offs onto the screws coming from the floor
the front panel of the unit, should be un- of the unit. And use the wrench to secure
plugged to assist in installation. the kep nuts onto the screws coming from
3. Remove the rear PANEL by slowly the right panel of the unit.
sliding the panel upward along its track in 10. Replace the unit’s rear panel by sliding
the two side panels until it is free of the it down along the track in the two side
unit, taking care not to damage or discon- panels until it is back in position. When
nect the connections attached to the panel. reassembling, care should be taken not to
4. The battery is located along the center of crimp or damage any wiring located in
the right panel of the unit under a clear these areas.
bracket. The bracket is secured with two 11. Replug the gray printer cable to the
kep nuts and two standoffs. Use the front panel. Replace the top cover by
wrench to remove the kep nuts and nut aligning the four locating tabs and pushing
driver to remove the standoffs. Remove the down on the cover. The cover will snap into
bracket by pulling it first free from the position.
screws located on the floor of the unit and
then free of the screws located on the right 12. Prior to applying power, the F2 fuse
panel of the unit. must be removed. Insert a small flathead
screwdriver into the slot on the F2 fuse
5. Trace the battery's cable from the battery holder, press inward and turn the holder
to its connector on the lower of the two counterclockwise. Remove the fuse and
PCBs located in the left rear of the unit. holder.
Unplug the connector. Carefully reroute the
cable and remove the battery from the unit. Plug the power cord into the unit and then
into an appropriate outlet. Turn the unit On.
6. Place the new battery on the foam pads
now visible in the interior of the unit. The With the F2 fuse in the holder, use the
battery's cable and connector should come flathead screwdriver to push the holder into
from the front left of the battery when the the unit, turning it clockwise until it is reseat-
battery is oriented correctly within the unit. ed.
7. Place the bracket over the battery, by 13. The battery may need to be charged for
aligning the holes in the bracket with the a minimum of eighteen hours to ensure it is
corresponding screws coming from the at full capacity.
right panel of the unit and then the screws 14. Dispose of the spent battery in accord-
coming out of the floor. Insure the battery's ance with local, state, and federal
cable is coming from between the battery regulations.
and bracket toward the front of the unit.
8. Thread the battery's cable and connector
between the two PCBs located in the left
rear of the unit and in front of the standoff
located on the right rear corner of the
PCBs. Plug the connector into the lower
PCB in the connection location available on
the rear of the PCB. The locking clip on the

10-5
ACTALYKE XL TEN - Maintenance, Troubleshooting, Warranty

1. Use the lid key on the TOP slot

2. Use the lid key on the BOTTOM
slot
3. BATTERY CONNECTOR
4. STANDOFFS
5. BATTERY CABLE
6. KEP NUTS
1
7. BRACKET
8. BATTERY
13
9. Use the lid key on the BOTTOM
2 slot
10. LID KEY
11. REAR PANEL
12. Use the lid key on the TOP slot
13. TOP COVER

12 6 7
3

11
4

10

Figure 10-1. Battery Replacement

10-6
 Month/Year: Serial Number:

ACTALYKE® XL Preventive Maintenance Schedule

Daily, If Used 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31
ACTALYKE XL

Clean the Instrument

Check Clotting Times (ECT)

Weekly

Check Well Temperatures

Monthly Items

Clean the Test Wells

10-7
Quarterly

Drain Battery

Touch Screen Calibration

As Needed

Replace Printer Paper

Figure 10-2. Preventive Maintenance schedule Checklist

Replace fuse(s)

Mag Sensor Calibration

Replace Battery
TEN - Maintenance, Troubleshooting, Warranty

Note: Duplicate this page for maintenance copies. Initial each item as required. Refer to section ten, Maintenance, of the Operator's Manual for details.
If you are uncertain about how to perform any step, please contact Helena Laboratories Electronic Customer Service Dept. (1-800-231-5663) for more information.
ACTALYKE XL TEN - Maintenance, Troubleshooting, Warranty

10.2. Troubleshooting
If the unit appears to be malfunctioning for any reason, thoroughly check for physical damage to
the case, indicators, etc. caused by dropping or excessive mishandling. Should instrument
problems be suspected, it is recommended that several tests be run using Actalyke Quality
Control material and whichever test tubes are used clinically. Results from these tests will be
helpful in identifying any potential trend in test results that could indicate a fault within the
system. For further information, refer to the Actalyke Quality Control Package Insert.
The following tables list other symptoms and possible fault conditions and causes (Table 10-2,
Troubleshooting and Table 10-3, Prompts and Error Messages).
Note: The floppy disk from the Actalyke XL has been removed. Any functions associated with
it are no longer available.
Table 10-2. Troubleshooting
Symptom Possible Cause(s) Action Required
Excessive sample clotting time Test well temperature out of range Verify Temperature QC (section
8.1.6), if OK, rerun patient test, if
out of range, call Helena Labora-
tories.
Test well control problem Verify Clotting Time QC (section
8.1.1), if OK, rerun patient test, if
out of range, call Helena Labora-
tories.
High heparin concentration Verify QC (section 8.1), if OK, rerun
sample patient test, if out of range, call
Helena Laboratories.
Short sample clotting time Tube not detected and instrument Rerun patient test.
aborted test
Test well temperature out of range Verify Temperature QC (section
8.1.6), if OK, rerun patient test, if
out of range, call Helena Laborato-
ries.
Unable to clear displayed error Instrument needs to be reset Turn power Off, wait 10 seconds,
turn power On.
Defective display module Call Helena Laboratories.
LCD touch screen is slow to Instrument needs to be reset Turn power Off, wait 10 seconds,
respond, responds erratically, or turn power On.
is non-responsive Touch screen needs calibration Perform the Touch Panel
Calibration (section 10.1.5).
Instrument has no power See Troubleshooting symptom
'No power to instrument.'
Instrument malfunction Call Helena Laboratories.
Tube indicator not responding Tube not fully inserted into test well Reinsert tube.
properly (In/Out) Magnet inverted in tube Discard tube.
Faulty tube Remove tube and insert ECT, if
detector changes to In, discard
tube.
10-8
ACTALYKE XL TEN - Maintenance, Troubleshooting, Warranty

Symptom Possible Cause(s) Action Required

Detector malfunction Perform the Mag Sensor Calibra-
tion (section 10.1.9).
Tube will not rotate Obstruction in test well Clean test well.
Defective drive mechanism Call Helena Laboratories.
Poor Precision Inaccurate tube agitation Refer to procedure supplied with
the tubes for instructions.
Inaccurate sample volume Refer to procedure supplied with
the tubes for correct volume.
Inconsistent time interval between Refer to procedure supplied with
inserting sample into the tube and the tubes for instructions.
beginning test timer
Unable to run patient tests Required QC/ECT tests not Complete the QC and/or ECT
complete required.
Alter the QC and/or ECT require-
ments (section 6.2.4.1 and 6.2.5.1)
Call Helena Laboratories.
Clotting time ECT not in range Insufficient charge in ECT battery Replace battery; see the ECT
instructions.
ECT malfunction Perform QC (section 8.1.2). If in,
call Helena Laboratories.
Magnetic detector malfunction Perform the Mag Sensor Calibra-
tion (section 10.1.9).
Call Helena Laboratories.
Temperature quality control not in Insufficient charge in thermometer Replace battery.
range battery
Test well control problem Call Helena Laboratories.
Unable to use barcode reader to Incorrect screen displayed when Return to Run Test screen and
scan in new QC range limits barcode label was scanned re-scan label (section 8.1.2).
Printer not working Paper jammed Adjust serrated plate position and
inspect mechanism.
Printer mechanism/driver fault Call Helena Laboratories.
Poor printout quality Printout too light due to low Increase contrast level (section
contrast level 6.1.5.1)
Printout too dark and/or illegible Decrease contrast level (section
due to high contrast level 6.1.5.1).
Printer mechanism/driver fault Call Helena Laboratories.
Individual coagulation assays QC Inconsistent time interval between Refer to procedure supplied with
not in range inserting sample into the tube and the tubes for instructions.
beginning test timer
Incorrect test type and/or level Repeat test.
selected
New lot of QC test in use and Enter new range limits (section
range limits not updated 6.2.4.3) and repeat test.

10-9
ACTALYKE XL TEN - Maintenance, Troubleshooting, Warranty

Symptom Possible Cause(s) Action Required

Faulty tube Repeat test. If remains out of
range, call Helena Laboratories.
No power to instrument Power cord unplugged and Plug cord into wall outlet and turn
insufficient charge in battery On to use and charge battery.
Battery charge depleted (power Turn power Off, remove fuse F2,
cord plugged into wall outlet, turn power On, replace fuse F2.
power switch turned On and Recharge the battery (section
instrument remains 7.4).
non-functional)
Fuse blown Check fuses and replace, if
required (section 10.1.8).
Battery never reports Charged, Battery is retaining charge Perform Drain Battery (section
always reads Charging memory 10.1.6).
Spent battery Replace battery (Catalog Number
5759).
Other Call Helena Laboratories.
Failure to initialize after the Battery fully discharged Recharge the battery (section 7.4)
instrument has been unplugged

10-10
ACTALYKE XL TEN - Maintenance, Troubleshooting, Warranty

Table 10-3. Prompts and Error Messages

Message Possible Cause(s) Action Required
Patient ID entry required for Patient ID Entry set to On, ID Auto Enter/re-enter patient ID (7.1.1.1).
well #X Entry Interval in use and time
interval has elapsed.
ACT required ACT Timing Sequence in use and Run an ACT test (7.1.1).
time interval has elapsed.
QC(bio) required, ECT required, QC(bio) and/or ECT Schedule Run a QC and/or ECT test (8.1).
QC(bio) should be run first, or selected time interval has
ECT should be run first elapsed.
No acknowledgement from LIS, Instrument and LIS not connect- Connect instrument and LIS.
touch screen to continue. Unable ed.
to establish communication. External computer (LIS) commu- Verify LIS status.
Aborting transfer, touch screen to nication problems.
continue. (ASTM protocol in use)
Instrument communication Call Helena Laboratories.
problems.
Warning - Temperature out of If instrument on battery power, Rerun test.
range in well X. Touch screen to heaters not back up to tempera-
continue. ture after instrument shut heaters
down to conserve battery.
If instrument not on battery power Perform Temperature QC (8.1.6)
or the problem persists, possible and call Helena Laboratories.
instrument malfunction.
Maximum entries per patient (=8) The maximum of eight heparin Clear clot times (7.1.1.1.6)
reached. Touch screen to dosages have been attributed to
continue one patient ID.
Maximum number of QC runs The maximum of 200 QC test Delete excess QC data (8.1.4 or
reached in well X. results have been stored. 8.1.5).
Exceeded maximum number of Due to the quantity of QC data, Delete excess QC data (8.1.4 or
QC runs in well X. the test results will display on the 8.1.5).
Run Test screen; however, will
NOT be charted, saved, or
transmitted.
Incomplete or invalid data for The QC test and level selected to Enter lot and range data (6.2.4.3
x-ACT level x. Must have a mean run has no stored lot number or 8.1.2).
and range entered for QC to and/or range data.
calculate Levey-Jennings chart.
Touch screen to continue.
TPATN fails to go low after reset. Instrument powered Off and then Touch the screen, turn power Off,
TPATN fails to go high after reset. back On too quickly. wait 10 seconds, turn power On.
Failed to reset ADC.
Incomplete reset to ADC.
Barcode is missing or unreadable Barcode missing or unreadable Select the appropriate test from
in well X. Please select test. and test type was not manually those shown.
selected.

10-11
ACTALYKE XL TEN - Maintenance, Troubleshooting, Warranty

Message Possible Cause(s) Action Required

Barcode on tube (x-ACT) in well Y Patient test manually entered To save results as the test type
disagrees with test specified. incorrectly or barcode misread. indicated, select Yes; otherwise,
Save clotting time as z-ACT? No select No. If No is selected, use
Yes the displayed screen to select the
appropriate test from those shown
unless both wells contain no or
the same patient ID, then the test
is aborted.
Barcode on tube (x-ACT) in well Y QC test manually entered Select the appropriate test from
disagrees with test specified (z- incorrectly or barcode misread. those shown.
ACT). Please re-select test.
Indication of stuck magnet in If performing patient test, magnet Remove tube, lightly tap bottom of
well #X. in tube not turning. tube on table top, and return tube
to well.
If performing ECT QC test or Perform the Mag Sensor Calibra-
message occurs repeatedly, tion (section 10.1.9).
magnet sensor out of calibration.
No tube detected in well #X. No tube in well after 45 seconds Prior to 90 seconds, quickly insert
of test (or until 90 seconds at test in well. After 90 seconds,
which time test is automatically repeat test.
aborted).
Failed to zero. Please ensure no Tube in well when Start was Quickly, touch screen to clear
tube in the well when pressing the selected. message, remove tube, re-select
start button. Start, and re-insert tube.

10-12
ACTALYKE XL TEN - Maintenance, Troubleshooting, Warranty

10.3. Warranty Trademarks and Copyright

Helena Laboratories warrants its products to Actalyke®, Actalyke® Mini and Actalyke® XL
meet Helena’s published specifications and are registered trademarks of Helena Labora-
to be free from defects in materials and tories, Inc. This manual is protected under
workmanship. Helena’s liability under this copyright laws of the United States.
contract or otherwise shall be limited to
replacement or refund of any amount not to
exceed the purchase price attributable to the
goods as to which such claim is made.
These alternatives shall be the buyer’s
exclusive remedies. In no case will Helena
Laboratories be liable for consequential
damages even if Helena has been advised
as to the possibility of such damages.
The foregoing warranties are in lieu of all
warranties expressed or implied, including,
but not limited to, the implied warranties or
merchantability and fitness for a particular
purpose. In no event will Helena Laborato-
ries be liable for indirect, incidental or
consequential damages; the original user’s
remedies being limited to repair or replace-
ment at the manufacturer's option.
Warranty Duration
This warranty is provided to the original
purchaser for one year from date of sale.
Particular Exclusions
Unauthorized modification of any part of the
Actalyke XL instrument will void this Warran-
ty.
10.4. Regulatory Information
The Actalyke XL System conforms to the
following general, safety and EMC require-
ments:
General: EMC directive 89/336/EEC
and Low Voltage Directive 72/23/EEC
EMC: EN 55011; IEC 801-(2, 3, 4, 5);
ENV 50204, EN 60601-1-2
CLIA Regulations: Please refer to
Section EIGHT for “Quality Control.”

10-13
ACTALYKE XL ELEVEN - Symbology

Section 11 - Symbology
NOTE: The following symbols may be used in this manual, or on the instrument, to provide
information necessary to the user, if applicable.

Caution, electric shock hazard, high voltages capable of causing personal

injury - shut down the instrument and unplug the power cord before touching
- do not operate with the cover(s) removed

Caution, heat hazard - allow heated components to cool before handling

Caution, general hazard - see Precautions and Hazards (Sections 3 and 4)

of Operator’s Manual before proceeding

Direct current

Alternating current

Both direct and alternating current

Ground (earth) terminal

Protective conductor terminal (grounded conductors)

Frame or chassis terminal

Equipotentiality (conductor with all parts at a single potential)

On (power switch)

Off (power switch)

Equipment protected throughout by double insulation or reinforced insulation

(equivalent to Class II of IEC 536)

European authorized representative

Manufacturer

Indicates "do not place in trash" in countries or regions requiring recycling and
other specific handling, such as in Europe, under the WEEE (Waste Electrical
and Electronic Equipment) Directive, 2002/96/EC

11-1
ACTALYKE XL TWELVE - Communication Specifications

Section 12 - Communication unless the Actalyke XL is to be connected to

Specifications a terminal.
Note: The floppy disk from the Actalyke XL XON-XOFF Flow Control:
has been removed. Any functions associated Data is transmitted and received as ASCII
with it are no longer available. text and XON/XOFF (ASCII codes 17 and
INTERFACE SPECIFICATIONS: 19) handshaking is used to control data flow.
When exporting, the Actalyke XL will recog-
The Actalyke XL import/export interface
nize an XOFF character and stop
conforms to the EIA standard RS-232C and
transmission until an XON character is
is configured as a DTE (Data Terminal
received. There is no error checking or
Equipment). Only RECEIVE DATA,
correction when using this protocol.
TRANSMIT DATA and SIGNAL COMMON
lines are used. The baud rate is user ASTM Protocol (E1381-95 and E1394-97):
selectable at 300, 1200, 2400, 4800, 9600, This protocol provides procedures for link
14400, 19200, 28800, 38400, and 57600 connection and release, delimiting and
baud. The number of data bits may be set at synchronism, sequence control, error
7 or 8 and the number of stop bits may be detection and error correction. Data is
either 1 or 2. Parity may be set to none, transmitted and received as ASCII text and
even, or odd. Protocol options include no some restrictions are placed on which
protocol, XON-XOFF flow control, or ASTM characters can be used in the data content.
protocol. The restricted characters are: <SOH>,
<STX>, <ETX>, <EOT>, <ENQ>, <ACK>,
MECHANICAL SPECIFICATIONS: <DLE>, <NAK>, <SYN>, <ETB>, <LF>,
9 pin D-shell connector (male): <DC1>, <DC2>, <DC3>, and <DC4>.
Pin Description There are three distinct phases in transfer-
1 receive line detect ring information between the Actalyke XL
2 receive data* and the computer system. In each phase,
3 transmit data* one system directs the operation and is
4 data terminal ready responsible for continuity of the communica-
5 signal common* tion. The three phases assures that the
6 data set ready actions of the sender and the receiver are
7 request to send coordinated. The three phases are Estab-
8 clear to send lishment, Transfer, and Terminate.
9 ring indicator
Establishment Phase
*only these lines are used by the Actalyke XL
software. The Establishment phase determines the
direction of information flow and prepares the
COMMUNICATIONS PROTOCOL: receiver to accept information. The sender
notifies the receiver that information is
The protocol used by the Actalyke XL available. The receiver responds that it is
software is user selectable (section 6.1.6). prepared to receive before information is
Listed below are the protocol options transmitted. A system, which does not have
available. information to send normally, monitors the
No Protocol: data link to detect the establishment phase.
It acts as a receiver, waiting for the other
Data is transmitted and received as ASCII system.
text with no flow control or error checking/
correction. This option is not recommended The system with information available initiates
the establishment phase. After the sender
12-1
ACTALYKE XL TWELVE - Communication Specifications

determines the data link is in a neutral state, it End Frame: <STX> FN "data" <ETX> C1 C2
transmits the <ENQ> character to the <CR> <LF>
intended receiver. Upon receiving the Where:
<ENQ>, the receiver prepares to receive <STX> - Start of text transmission character
information. All other characters are ignored. FN - single digit frame number "0" to "7"
It replies with the <ACK> character to signify it "data" - data content
is ready. With this sequence of events, the C1 - first character of checksum
establishment phase ends and the transfer "0" - "9" & "A" - "F"
phase begins. C2 - second character of checksum
A receiver that cannot immediately receive "0" - "9" & "A" - "F"
information replies with the <NAK> charac- <ETB> - end of transmission block character
ter. Upon receiving the <NAK>, the sender <ETX> - end of text transmission character
must wait at least 10 seconds before <CR> - carriage return character
transmitting another <ENQ>. <LF> - line feed character
Should both systems simultaneously transmit The frame number is an ASCII digit ranging
an <ENQ>, the data link is in contention. from "0" to "7". The frame number begins at
The Actalyke XL has priority to transmit "1" with the first frame of the transfer phase.
information when contention occurs. The frame number is incremented by one for
Contention is resolved as follows. Upon each new frame transmitted. After "7", the
receiving a reply of <ENQ> to its transmitted frame number rolls over to "0".
<ENQ>, the computer system must stop The checksum permits the receiver to detect
trying to transmit; it must prepare to receive. a defective frame. The checksum is encod-
When the next <ENQ> is received, it replies ed as two characters, which are sent after
with an <ACK> or <NAK> depending on its the <ETB>, or <ETX> character. The
readiness to receive. checksum is computed by adding the binary
Transfer Phase values of the frame characters, keeping the
least significant eight bits of the result. The
During the transfer phase, the sender
checksum is transmitted as ASCII hexadeci-
transmits information to the receiver. The
mal.
transfer phase continues until all information
has been sent. The checksum is initialized to zero with the
Information is sent in frames, each frame <STX> character. The first character used in
computing the checksum is the frame
contains a maximum of 247 characters
number. Each character in the data is added
(including frame overhead). Records or data
to the checksum (modulo 256). The compu-
that are longer than 240 characters are
tation for the checksum does not include
divided between two or more frames. A
<STX>, the checksum characters, or the
frame is one of two types, an intermediate
trailing <CR> and <LF>.
frame or an end frame.
After the frame is sent, the sender stops
Intermediate frames terminate with the
transmitting until a reply is received. The
characters <ETB>, checksum, <CR> and
receiver replies to each frame. A reply of
<LF>. End frames terminate with the
<ACK> signifies the last frame was received
characters <ETX>, checksum, <CR> and
successfully and the receiver is prepared to
<LF>. The frame structure is illustrated
receive another frame.
below:
A reply of <NAK> signifies the last frame was
Intermediate Frame: <STX> FN "data"
not received successfully; the receiver is
<ETB> C1 C2 <CR> <LF>
prepared to receive the frame again. Upon

12-2
ACTALYKE XL TWELVE - Communication Specifications

receiving the <NAK>, the sender retransmits During the establishment phase, the sender
the last frame with the same frame number. sets a timer when transmitting the <ENQ>. If
In this way, transmission errors are detected a reply of an <ACK>, <NAK> or <ENQ> is
and automatically corrected. A frame is not not received within 15 seconds, a timeout
successfully received if any of the following occurs and the sender regards the link to be
occur: in the neutral state.
1 - any character errors are detected (parity During the establishment phase, if the
error, framing error, etc.) computer (as receiver) detects contention, it
sets a timer. If an <ENQ> is not received
2 - the frame checksum doesn't match the
within 20 seconds, a timeout occurs and the
checksum computed on the received frame.
receiver regards the link to be in the neutral
3 - the frame number is not the same as the state.
last accepted frame or one higher (modulo 8).
During the transfer phase, the sender sets a
A frame may be retransmitted up to 6 times. timer when transmitting the last character of
If after 6 tries the frame has still not been a frame. If a reply is not received within 15
successfully transmitted, the sender trans- seconds, a timeout occurs. After a timeout,
mits an <EOT> and regards the data link to the sender aborts transmission by proceed-
be in the neutral state. ing to the termination phase.
A reply of <EOT> signifies the last frame was During the transfer phase, the receiver sets a
received successfully, the receiver is ready timer when first entering the transfer phase
to receive another frame, but is a request to or when replying to a frame. If a frame or
the sender to stop transmitting. The sender <EOT> is not received within 30 seconds, a
does not have to stop transmitting after timeout occurs. After a timeout, the receiver
receiving the request. If it continues to discards the last incomplete record or set of
transmit, there is a possibility of overflowing data and regards the link to be in the neutral
the receiver's buffers. If the sender chooses state.
to ignore the <EOT>, the receiver must
DATA TRANSFER FORMAT
retransmit the request.
The Actalyke XL software in general adheres
Termination Phase
to the ASTM Standard Specification for
The termination phase returns the data link Transferring Information Between Clinical
to the clear or neutral state. The sender Instruments and Computer System. The
notifies the receiver that all data has been exceptions concern sending a QC record.
sent.
General Information
The sender transmits the <EOT> character
Data is exchanged in records of different
and then regards the data link to be in a
types. Each record is introduced by field
neutral state. Upon receiving the <EOT>,
number 1 identifying the record type, and
the receiver also regards the data link to be
terminated by a carriage return. There are 5
in the neutral state.
record types used by the Actalyke XL:
Timeouts Header Record (H), Patient Record (P), Test
The sender and receiver both use timers to Order Record (O), Result Record (R), and
detect loss of coordination between them. the Terminator Record (L).
The timers provide a method for recovery if Since the Actalyke has a minimal amount of
the communication line or the other device data per run to send, only one clotting time
fails to respond. will be sent per message and therefore only
one result record, one test order record, and

12-3
ACTALYKE XL TWELVE - Communication Specifications

one patient record (for a patient - no patient caret, "^"). The component delimiter is used
record for QC) will be sent per message. to separate data elements of fields of a
hierarchical or qualifier nature.
NOTE: The record ID field shall be case
insensitive. Header Record
Records are related to each other in a The header record must always be the first
definite hierarchy. At level zero is the record in a transmission. When the Actalyke
Header record and Terminator record. At XL transmits a header record, it will have the
level one is the Patient record and the following format:
Request-Information record. At level two is H|\^&|||Helena Laboratories^Actalyke XL^
the Test Order record. At level three is the Versionn.nn^SNnnnnnnnn|||||||P|1394-97
Result record. |yyyy mmddhhmmss
A sequence of patient records, order records, n.nn - Actalyke XL software version number
or result records at one level is terminated by
the appearance of a record type of the same SNnnnnnnnn - Instrument serial number
or higher level. Thus, a sequence of results yyyymmddhhmmss - 4-digit year, 2-digit
for one patient is terminated by the next month, 2-digit day, 2-digit hour, 2-digit min.,
patient record. 2-digit seconds.
Each record is composed of fields, which are Patient Record
position sensitive and variable in length.
Each field is separated by a field delimiter A patient record is not included when
(the vertical bar, "|"). The position sensitivity sending QC data.
requires that when the contents of a field are EXAMPLE: P|1||12|||||F||||||||0|0|
null, its corresponding field delimiter must be
included in the record to ensure that the i'th Order Record
field can be found by counting (i-1) delimit- The Actalyke XL will transmit an order record
ers. Delimiters are not included for trailing immediately preceding any results records
null fields; that is, if the tenth field was the for a patient as required in the ASTM
last containing data, the record could specification. The format will be as follows:
terminate after the tenth field (with a carriage O|1|||^^^test name||| ||||||||lvl^lot number<CR>
return) and therefore would contain only nine
delimiters. test name - Name of the test performed.

A system may transmit a null value for a field lvl - QC level when sending QC data
because (1) it does not know the value, (2) it lot number - Lot number associated with
knows the value is irrelevant to the receiving the QC level
system, or (3) the value has not changed
All order records will provide a sequential
since the last transmission, or any combina-
test number (up to 4 billion) in the fourth field
tion thereof. Because the sending system
(Instrument specimen ID).
can use null values to indicate no change, a
null value does not overwrite existing data in EXAMPLE:
the receiving system. The transmission of a For a patient: O|1||7|^^^G-ACT|
double quote (ASCII 34) in a field tells the
receiving system to replace any existing For QC data the associated level and lot
value with a null value. number will be included in the specimen
descriptor field (field number 16) of the order
Each field may be composed of record: O|1||8|^^^ECT|||||||||||Level 1|
sub-components. These sub-components
are separated by a component delimiter (the

12-4
ACTALYKE XL TWELVE - Communication Specifications

The Actalyke XL currently does not recog- transmits a terminator record it will have the
nize test order records transmitted by the following format: L|1|<CR>
computer system.
Result Record
Each clotting time will be transmitted as a
separate result record.
For patient results, if test range limits have
been entered, they will be included in the
sixth (reference ranges) field.
For QC results, the range entered for the lot
will be included in that field.
The ninth (result status) field always shows
"F" for Final results.
An ACT result will be transmitted in the
following format:
R|n|^^^test name|nnnn|unit of measure|nnnn-
nnnn|||||F|||date/timestarted|date/timecomplet
ed<CR>
n - Sequence number - always 1.
test name - Name of the test performed.
nnnn - Clotting time
unit of measure - seconds
nnnn-nnnn - User defined reference range.
date/time started - Date and time the test
was started (yyyymmddhhmmss). The date
is transmitted with the year first, month
second and day last.
date/time completed - Date and time the
test finished
The Actalyke XL does not recognize result
records transmitted by the computer system.
EXAMPLE:
For patient result record:
R|1|^^^G-ACT|139|sec||||F|||2002050314380
9| 20020503144028|
For QC result record:
R|1|^^^ECT|130 |sec|90 to 10|||F|||20020502
094336| 20020502094546|
Terminator Record
The terminator record must be the last record
in a transmission. When the Actalyke XL
12-5
 Run Test

Setup Setup
ACTALYKE XL

Interface
Time & Date Setup Time & Date Date Format Set Date Format
Parameters

Date Set Date

Setup Interface
Section 13 - Menu Flowchart

Parameters

Time Set Time

Sound Setup Sound

OR

13-1
Select Preferred
Keypad
Keypad

Backlight Set Backlight

Printer Contrast
Printer Setup Printer Contrast
Adjustment

Set Printer Report

Header
Header

Set Printer Report

Footer
Footer

Setup Export
Export
Parameters
THIRTEEN - Menu Flowchart
 Interfaface
Parameters
continued
Set Spreadsheet
Spreadsheet
Parameters

Setup
ACTALYKE XL

continued Set Select Shutdown

System Shutdown
Timer Time-out
System
Timers
Select Operator ID
Operator ID Entry Yes
Time-out

General Select Editable

Patient
Parameters Demographics

set Op 2
General Parameters

Test Setup Test Parameters set Sequence ACT Timing Sequence

Run Test
continued

set Limits ACT Test Range Limits

13-2
set must
QC (Bio)
pass levels

Set QC
QC Schedule
Schedule
Setup QC

OK QC Mean and Range

C-ACT

QC Lot Numbers 1, 2,
or 3

G-ACT
1, 2,
or 3
Enter Lower Limit

K-ACT
Enter Lot Numbers OK OK

MAX-ACT Enter Upper Limit

OK
THIRTEEN - Menu Flowchart
 set must
pass levels

ECT Setup ECT

Set ECT
ECT Schedule
Schedule
Setup
ACTALYKE XL

continued
Operator ID/
Initial
Passwords

General
Parameters Enter/Edit
continued enter ID Enter Password enter password
Password

Supervisor
Delete Full Rights
Enter Operator ID List select ID
Selected
Setup
Access
OK

Save/Restore Save Restore Cancel Operation

Only

Auto Output Setup Automatic Output

Run Test

13-3
continued
Paper Feed

Mag Sensor Remove

Continue insert ECTs Continue follow prompts
Calibration all tubes

Draining Battery for

Maintenance Drain Battery
Cycling

Touch Panel Touch upper Touch upper Touch lower Touch lower
Calibration left corner right corner left corner right corner

Save Restore Print Setup

Parameters Parameters Parameters

Archive Save/Restore/Print

Print
Save Restore
Operator ID
Operator IDs Operator IDs
THIRTEEN - Menu Flowchart

List
 Change Enter Operator ID
Operator

Run Test
continued
OR
Main
ACTALYKE XL

Enter Well 2
Well 2
Operator ID

View Chart OR Result ACT

Well Save Print Chart Transmit

Test
or Patient
OR

Patient ID
Well #
or Patient

13-4
Clear List Test select test

Patient ID & Patient ID

Test Entry/Selection
Patient Demographics
Delete
enter ID select ID
Selected
Sex

OK Update
Height Select Patient Height

Weight Select Patient Weight

Clear ACT
Points

Heparin Heparin Dosage

THIRTEEN - Menu Flowchart
 Run Test
continued
ACTALYKE XL

Run ECT Self

QC select Well 1 or 2 select seconds
Check

QC Options

Run Biological
QC Test
QC (Biological) Change Test select test select level

Test Well Save

View/Output Levey-Jennings Chart

13-5
Previous
Next Page Print Chart Transmit
Page

Delete
Complete QC select well select test
Test Data

Test Well Level

Delete Single
QC Clot Point
select test QC Point Deletion

Previous
Next Page Delete
Page
THIRTEEN - Menu Flowchart
ACTALYKE XL FOURTEEN - Index

Section 14 - Index
Clear ACT Points, 7-6
A
Clotting Time Check, 8-1, G
Abort, 7-2, 7-8 10-1
G-ACT, 5-1, 6-13, 6-18, 7-1,
Access Level, 6-1, 6-7, 6-8, Clotting Time Tests, 7-1
7-2, 7-7, 8-2, 8-3, 8-4
6-15, 6-20, 7-1 Column Labels, 6-6
General Parameters, 6-7, 6-
ACT Test Range, 6-11, 6- Complete Curve, 6-15, 7-7,
8, 6-9, 6-10, 6-11, 6-12,
17, 6-18, 6-27 8-3
6-13, 6-14, 6-15, 6-25
ACT Timing Sequence, 6- Contrast, 6-4, 6-24
11, 6-17, 6-26, 7-2
H
Actalyke Thermal Printer D
Paper, 5-1 Hazards, 4-1
Data Bits, 6-5, 6-19
Actalyke Thermometer, 5-1, Header, 6-4, 6-19
Date, 6-2, 6-3, 6-19, 6-22
8-4, 10-2 Header/Footer, 6-4
Date Format, 6-2, 6-19, 6-
Actalyke XL Battery Pack, Height, 6-10, 6-17, 7-5, 7-
22
5-1, 10-4 12
Delete, 7-4, 8-3, 8-4
Additional Materials, 5-1 Heparin, 6-9, 7-6, 7-12
Delete Complete QC Test
Allow 2nd Operator for Well Heparin Dosage, 7-6
Data, 8-3
2, 6-1, 6-7, 6-11, 6-18, 7- High/Low Limits, 6-11, 6-28
Delete Patient ID, 7-4
1, 7-8, 7-9
Delete Single QC Clot I
AQC-H, 5-1
Point, 8-3, 8-4
AQC-L, 5-1 ID Auto Entry Interval, 6-10,
Demographics, 6-10, 6-26,
Archive, 6-8, 6-16, 6-19, 6- 6-17, 7-2
7-2
20 Incubation Temperature, 9-
Dimensions, 9-1
ASTM, 12-1, 12-3, 12-4 1
Drain Battery, 10-2, 10-3
Auto Output, 6-14, 6-15, 6- Installation, 5-1
29 Instrument Operating
E
Automatic Output. See Auto Environment, 9-1
Output ECT, 5-1, 6-14, 6-18, 6-28,
Instrument Performance
6-29, 8-1, 8-3, 8-4, 10-1,
Specifications, 9-1
B 10-2
Instrument Use and
ECT Levels Which Must
Backlight, 6-3, 6-19, 6-23 Function, 1-1
Pass, 6-14, 6-19, 8-1
Barcode Reader, 5-1, 5-2, Interface Parameters, 6-1,
ECT Schedule, 6-14, 6-19,
6-1, 6-8, 6-12, 6-13, 7-1, 6-2, 6-3, 6-4, 6-5, 6-6, 6-
6-29
7-3, 7-8, 8-2 7, 6-21
Electronic Clotting Tube,
Battery, 5-1, 5-2, 6-6, 7-1, Inventory, 5-1
10-1
7-8, 7-9, 10-2, 10-3, 10-4 Item Separation Character,
Enter Operator ID, 6-1, 6-7,
Battery Charging, 7-8, 10-3 6-6, 6-19
6-21, 6-25, 7-1, 7-8, 7-9,
Battery Replacement, 10-4
7-11 K
Baud Rate, 6-5, 6-19, 12-1
Enter Well 2 Operator ID, 7-
Biological, 6-12, 8-2, 8-5 K-ACT, 5-1, 6-13, 6-18, 6-
8
Error Messages, 10-8, 10- 19, 7-1, 7-2, 7-7, 8-2, 8-3,
C 8-4
11
C-ACT, 5-1, 6-13, 6-18, 6- Export, 6-5, 6-19, 6-24, 7-7, Keyboard, 5-2, 6-1, 6-4, 6-
19, 7-1, 7-2, 7-7, 8-2, 8-3, 8-3 5, 6-6
8-4 Keypad, 6-1, 6-22
C-ACT, K-ACT, G-ACT, and F
MAX-ACT, 6-13, 7-1, 7-7, L
F2 Fuse, 5-2, 10-3
8-2 Leakage Current, 9-1
Floppy Disk, 6-5, 6-8, 6-9,
Calibration. See Mag Levey-Jennings Chart, 6-
6-15, 7-1, 8-2
Sensor Calibration 15, 8-3, 8-5, 8-6
Footer, 6-4, 6-19
Change Operator, 7-8
Fuse Replacement, 10-3
Cleaning, 10-1, 10-2
14-1
ACTALYKE XL FOURTEEN - Index

Line Termination String, 6- Precautions and Save Patient (spreadsheet),

6, 6-19 Limitations, 3-1 6-15, 7-7
Line Voltage, 9-1 Principles of Operation, 2-1 Save QC (spreadsheet), 6-
LIS, 5-2, 6-5, 6-9, 6-15, 7-1, Print, 6-15, 6-18, 7-7, 8-3 15, 8-3
7-7, 8-3 Print Operator ID List, 6-20 Save/Restore/Print, 6-29
Lot Numbers, 6-13, 6-18, 6- Print Setup Parameters, 6- Select Patient Height, 7-5,
27, 6-28, 8-2 16 7-12
Lower/Upper. See High/Low Printer, 6-3, 6-4, 6-23 Select Patient Weight, 7-5,
Limits Printer Paper, 5-1 7-12
Printer Paper Replacement, Select Test, 7-4, 7-7, 8-4
M 10-3 Serial Number, 6-3, 6-17, 6-
Prompts, 10-8, 10-11 19
Mag Sensor Calibration, 10-
Protocol, 6-5, 6-19, 12-1 Setup, 6-1, 6-2, 6-3, 6-4, 6-
4
5, 6-6, 6-7, 6-8, 6-9, 6-10,
Maintenance, 6-20, 10-1,
Q 6-11, 6-12, 6-13, 6-14, 6-
10-2, 10-3, 10-4
16, 6-19, 6-20, 6-21, 10-
MAX-ACT, 5-1, 6-13, 6-18, QC, 5-1, 6-12, 6-13, 6-15,
2, 10-3, 10-4
7-1, 7-2, 7-7, 8-2, 8-3, 8-4 6-27, 8-1, 8-2, 8-3, 8-4, 8-
Setup Access, 6-7
Mean and Range, 6-13, 6- 5, 8-6, 10-1
Sex, 6-10, 6-17, 7-4
18, 6-28 Storage Capacity, 8-3
Shutdown Time-out, 6-25
Measurement Range, 9-1 QC Mean and Range, 6-13,
Single Point, 7-7, 8-3
6-18, 6-28
O Software Installation, 7-9
QC of Individual
Software Version, 6-17
Coagulation Assays, 8-2
Operating Instructions, 7-1 Sound, 6-3, 6-19, 6-23
QC Point Deletion, 8-4
Operation Only, 6-7 Spreadsheet, 6-3, 6-5, 6-6,
QC(bio) Levels Which Must
Operator ID, 6-1, 6-3, 6-7, 6-19, 6-24
Pass, 6-12, 6-19, 8-1
6-8, 6-17, 6-19, 7-1, 7-8, Stop Bits, 6-5, 6-19
QC(bio) Schedule, 6-12, 6-
7-9 Storage Capacity, 7-1, 8-3
19, 6-27
Operator ID Entry, 6-6, 6-7 Supervisor Full Rights, 6-7
Quality Control, 8-1
Operator ID Time-out, 6-7, Symbology, 11-1
6-25 System Performance
R
Operator ID/Passwords, 6- Characteristics, 9-1
7, 6-8, 6-9 Regulatory Information, 10- System Shutdown, 6-6
13 System Timers, 6-6, 6-7
P Reset, 7-2
Restore, 6-9, 6-20 T
Paper Feed, 6-15, 6-16, 10-
Restore Operator IDs, 6-20
3 Temperature QC, 8-4
Restore Parameters, 6-16
Parity, 6-5, 6-19, 12-1 Test, 6-11, 6-26, 7-7, 8-3
Results, 7-8
Password, 6-1, 6-7, 6-26, 7- Test Tube, 9-1
Results ACT Chart, 6-15, 7-
1, 7-8 Test Well Temperature
2, 7-6, 7-7, 7-12, 7-13
Patient, 6-9, 6-10 Check, 8-4, 10-2
Retrieve, 6-8, 6-9
Storage Capacity, 7-1 Time, 6-2, 6-4, 6-19, 6-23
Run Biological QC Test, 8-2
Patient Demographics, 7-3, Time and Date, 6-2, 6-22
Run ECT Self Check, 8-1,
7-4, 7-5, 7-6, 7-11 Touch Panel Calibration,
10-1
Patient ID, 6-10, 6-15, 6-17, 10-2
Run Test, 6-21, 7-1, 7-11,
7-2, 7-3, 7-4, 7-5, 7-6, 7- Transmit, 6-15, 6-18, 7-7, 8-
8-5
11 3
Patient ID & Test, 7-3 Troubleshooting, 10-1, 10-8
S
Patient ID Entry/Selection,
7-3 Save, 6-5, 6-9, 6-15, 6-18, V
Performance Specifications, 6-19, 7-7, 8-3
Verification of Functionality,
9-1 Save Operator IDs, 6-19
5-2
Power, 9-1 Save Parameters, 6-16

14-2
ACTALYKE XL FOURTEEN - Index

View Chart, 6-15, 6-18, 7-7,

8-3
View/Output, 8-3

W
Warranty, 10-1, 10-13
Weight, 6-10, 6-17, 7-5, 7-
12, 9-1
Well 2 Operator ID. See
Allow 2nd Operator for
Well 2

X
XON-XOFF, 12-1

14-3
 Actalyke® XL
Catalog Number 5770
Software Version 1.70
Operator's Manual

For additional information, call

Helena Laboratories at 800-231-5663, toll free.

Helena Laboratories Helena Biosciences, Europe –

P.O. Box 752 - United Kingdom(Headquarters)
Beaumont, Texas 77704–0752 Queensway South,
USA Team Valley Trading Estate,
Gateshead, Tyne & Wear
U.K. NE11 OSD

© July, 2019 D6500093P

Helena Laboratories, Inc. 7/19