ITC ProTime Microcoagulation System User Manual
ProTime
Microcoagulation System
For in vitro Diagnostic Use
Operator’s Manual
TABLE OF CONTENTS
®
0123
INTENDED USE.............................................................................. 2
SUMMARY AND EXPLANATION.................................................... 2
SYSTEM FEATURES...................................................................... 3
IMPORTANT LABELS AND SYMBOLS ..........................................4
PRINCIPLES OF OPERATION .......................................................5
SAFETY FEATURES AND QUALITY CONTROL ........................... 5
INSTRUMENT SPECIFICATIONS .................................................. 7
SERVICE AND MAINTENANCE ..................................................... 7
PREPARING THE INSTRUMENT...................................................9
TEST PROCEDURE .....................................................................10
TROUBLESHOOTING ..................................................................14
MAIN MENU OPTIONS................................................................. 16
SET UP .........................................................................................22
FOR PROFESSIONALS ONLY - PROGRAM MODE.................... 27
PERFORMANCE CHARACTERISTICS ........................................ 31
TECHNICAL ASSISTANCE........................................................... 34
SUGGESTED READING............................................................... 35
SAFETY STANDARDS .................................................................36
INDEX ...........................................................................................39
This manual is published by International Technidyne Corporation (ITC) for use with the ProTime
Microcoagulation System and Tenderlett
Questions or comments regarding the contents of this manual can be directed to the address at the back of
this manual or to your ITC representative.
Please read the instructions before use.
© 2000, 2001, 2002, 2003, 2004, 2005. This document is the copyright of ITC and must not be copied or
reproduced in any form without prior consent. ITC reserves the right to make technical improvements to
equipment and documentation without prior notice as part of a continuous program of product
development.
®
Plus fingerstick blood collection device.
®
INTENDED USE
The ProTime Microcoagulation System is a portable, battery-operated instrument with a disposable cuvette
for quantitative determination of prothrombin time from fingerstick whole blood or anticoagulant-free
venous whole blood. The product is intended for use in the management of patients treated with oral
anticoagulants by a healthcare professional and for patient self-testing. Additional information for medical
professionals to monitor patients is located at the end of this instruction manual. Materials are available
through ITC for professionals to train patient self-testers using the ProTime Microcoagulation System.
ProTime instruments intended for patient self-testing are available in the U.S. by prescription only. These
instruments include patient-specific product instructions.
For in vitro Diagnostic Use.
SUMMARY AND EXPLANATION
What Does The ProTime Microcoagulation System Do?
The ProTime Microcoagulation System is designed for testing prothrombin time (PT) and International
Normalized Ratio (INR). The reagents for a prothrombin time test are in the cuvette. Whole blood clotting
time is converted to INR, than the result is calculated for plasma equivalent PT seconds. This test is done to
check the status of patients receiving oral anticoagulation therapy.
What is INR?
The International Normalized Ratio (INR) was developed to help the doctor compare an individual’s
prothrombin time results from one lab to another. An advantage of reporting an INR is to allow for
normalization of comparisons from one lab or instrument to another. The precision of the INR is improved
when a reagent with a lower ISI is used.
Note: ISI stands for International Sensitivity Index. ProTime uses this number to calculate PT
seconds from INR.
Blood Coagulation Test Methodology
Traditional coagulation tests measure the time required for the formation of a fibrin clot following the
addition of a coagulation-activating reagent. Laboratory assays typically use plasma recovered from
anticoagulated (citrated) whole blood samples. The clotting time is a measure of the functionality of the
patient’s hemostatic system. Specific coagulation activating reagents are employed in various clotting tests to
measure specific components of the hemostasis system. Clotting times are prolonged in the case of either
decreased procoagulant activity or increased anticoagulant activity.
Summary of the Blood Coagulation System
The events leading to the formation of a fibrin clot are simplified in coagulation theory into two coagulation
pathways: the intrinsic and the extrinsic pathways. There are twelve clotting factors or proteins involved in
this cascade scheme, numbered I through XIII (excluding VI). The prothrombin time test measures the
extrinsic coagulation pathway and is sensitive to coagulation Factors VII, X, V, II and Fibrinogen (I). With the
exception of Factor V, vitamin K is a required co-factor for biosynthesis of these factors in the liver. The
prothrombin time (PT) test uses thromboplastin as the active reagent to initiate the extrinsic pathway. The
prothrombin time test will be prolonged in patients with liver disease or vitamin K deficiency. The test is
widely used to monitor oral anticoagulant therapy that suppresses the synthesis of vitamin K-dependent
clotting factors.
2
SYSTEM FEATURES
1) Tenderlett 2) ProTime Cuvette
7) AC/DC Power Module
3) Display Panel
4) MENU/SCROLL
Button
5) START/SELECT
Button
6) Cuvette Entry Port
8) Input DC Port
9) Output Data Port
1.
Tenderlett Plus/Tenderlett Plus LV. The finger incision and blood collection device used with
ProTime and ProTime cuvettes.
2.
ProTime/ProTime3 Cuvette. The cuvette performs the PT test.
3.
Display Panel. The display panel prompts you through the test procedure, displays results and error
messages.
4.
MENU/SCROLL Button. The button is used to move through menu screens and to scroll through
results.
5.
START/SELECT Button. The button is pressed to turn ProTime on and off, to start the test and to
select menu items.
6.
Cuvette Entry Port. The cuvette entry port accepts only ProTime and ProTime3 cuvettes.
7.
AC/DC Power Module. The AC/DC power module is used to connect the ProTime instrument to the
AC power cord to recharge the battery.
8.
Input DC Port. Plug the DC power cord from the AC/DC power module into this port when
connecting the ProTime instrument to the AC/DC power module.
9.
Output Data Port. Use this port to download records in the ProTime memory.
3
IMPORTANT LABELS AND SYMBOLS
Before using the ProTime Microcoagulation System, it is essential that the contents of this Operator’s
Manual and any instructions accompanying the ProTime cuvettes and Tenderlett Plus incision devices are
read and understood by the operator. These materials make reference to various symbols that are
explained below:
Start/Select
Menu/Scroll
Expiration Date of Cuvettes
Serial Number of Device
Lot Number of Cuvettes/Tenderlett Plus
ITC Catalogue Number of Device
Do Not Reuse – Single Use Only
Upper and Lower Temperature Limitations (For Storage or Use)
For in vitro Diagnostic Use
Attention - Read Accompanying Documentation or Instructions
Consult Instructions for Use
Class II Protection Against Electrical Shock
Input Port for DC Power Cord from AC/DC Power Module - Polarity, VDC
and A Input
Output Port for Data Transfer
Name and Address of Manufacturer
4
PRINCIPLES OF OPERATION
The ProTime Microcoagulation System measures the PT using fibrin clot formation and detection. The
ProTime cuvette is a self-contained, micro volume reaction cell constructed of precision-molded plastic.
There are two user options within the ProTime Microcoagulation System: the standard ProTime cuvette and
the ProTime3 cuvette. These cuvettes differ from each other in the amount of blood that needs to be
collected and tested.
The standard ProTime cuvette has five micro-channels, which contain the dried reagents required to
perform triplicate testing of the PT assay and two levels of controls. The ProTime3 cuvette has three
functional micro-channels. Two micro-channels perform the controls, and one micro-channel performs the
PT test. The standard ProTime uses the Tenderlett Plus device for performing the fingerstick, and it is
designed to hold 65 µL of blood (approximately 3 drops) needed to fill all five micro-channels. The
ProTime3 uses the Tenderlett Plus LV (low volume) device for performing the fingerstick, and it collects 27
µL of blood (approximately 1 large drop) needed to fill the three micro-channels of the ProTime3 cuvette.
The instrument draws the precise volume of blood into the micro-channels of each cuvette, which contain
thromboplastin and other reagents. An array of LEDs detects the motion of sample/reagent mixtures as they
move through a precision restriction in each channel. The blood is pumped back and forth until a clot
forms, obstructing the channel and slowing the flow of blood. The instrument detects the clot when the
blood movement decreases below a predetermined rate.
SAFETY FEATURES AND QUALITY CONTROL
Each ProTime and ProTime3 cuvette has two channels for performing the two levels of control which work
simultaneous with the channel(s) used for testing the PT assay. The built-in safety features of the
instrument and integral reagent controls work together to ensure that the instrument and reagent systems
are working properly and that the test procedure was performed correctly. Two levels of quality control are
performed with each and every test.
Calibration
The ProTime instrument and cuvettes are pre-calibrated. No additional calibration is required.
Reagents
ProTime cuvettes are pre-loaded with dried thromboplastin, stabilizers and buffers. The thromboplastin
has a high sensitivity, measured as an ISI near 1.0. Each cuvette performs the prothrombin time test and,
in addition, has one channel for a Level I control and one channel for a Level II control. The controls
consist of purified plasma-extracted coagulation factors and anticoagulants.
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Operating Precautions
•
For in vitro Diagnostic Use.
•
The ProTime instrument is designed for use only with ProTime cuvettes.
•
The ProTime instrument will not perform a test if the cuvette is past its expiration date or has been
improperly stored.
•
The ProTime instrument is designed to be used for testing in a stationary position. DO NOT perform
testing while carrying or holding the instrument.
•
In order to charge the ProTime instrument, the AC power cord should be plugged into an electrical
service outlet and the AC/DC power module while the DC power cord from the AC/DC power module is
plugged into the DC port in the back of the ProTime instrument.
•
DO NOT expose the ProTime instrument to extreme temperature (above 35°C, 95°F). Such exposure
could affect the performance of any type of electronic instrumentation.
•
DO NOT drop the ProTime instrument, and do not use the results if the instrument is dropped during
a test.
•
DO NOT attempt to open the ProTime instrument other than for battery replacement, as there are no
user-serviceable parts.
•
DO NOT remove the AC/DC power module from the ProTime instrument by pulling on the cord.
Patient specimens and used cuvettes are potentially infectious. The cuvettes include materials that have
been prepared from human plasma or serum that has been tested using US FDA recognized methods and
found to be non-reactive for HIV antibody and for hepatitis B surface antigen. Handle with appropriate care and
dispose of cuvettes and blood collection materials in accordance with standard methods of biohazard control.
The use of accessory equipment (e.g., printers, etc.) not identified in this manual either in the patient
vicinity, or that does not comply with either the equivalent safety requirements of this equipment or
UL/IEC 60601-1 or IEC 60601-1-2, may lead to a reduced level of safety with the resulting system.
Limitations
•
The ProTime instrument uses only fresh capillary or venous whole blood. Plasma or serum cannot be
used. Glass tubes or syringes must not be used to collect venous samples. Use only plastic syringes
without anticoagulants to collect venous samples. Poor fingerstick blood collection technique may
affect results.
•
In clinical trials, no significant difference was observed between fingerstick and venous specimens run
on ProTime. During those trials, ProTime measured patients with an INR range of 0.8 to 7.0.
ProTime is programmed to calculate and report INR results as follows:
If the calculated INR is: Then ProTime displays:
< 0.6 INR LOW
0.6 - 0.79 INR < 0.8
0.8 - 7.0 Result
7.1 - 9.9 Result - followed by "*"
10.0 - 12.0 INR > 9.9
> 12.0 INR HIGH
•
Results may be affected in patients receiving heparin or who have an abnormal response to heparin.
•
Correlation of results reported by the ProTime instrument to laboratory results depends on the precision
of the laboratory method and on the ISI value of the laboratory reagent and instrument system.
•
Do not disturb instrument while test is in progress.
As with all diagnostic tests, ProTime Microcoagulation System test results should be scrutinized in light of a
specific patient’s condition and anticoagulant therapy. Any results exhibiting inconsistency with the
patient’s clinical status should be repeated or supplemented with additional test data.
Follow doctor’s instructions if you have difficulty performing the test or receive a result outside of the
prescribed therapeutic range.
6
Reagent Preparation and Storage
•
Bring the foil-pouched cuvette to room temperature prior to use.
•
ProTime cuvettes are ready-to-use. No additional preparation is required.
•
Store the foil-pouched cuvettes in a refrigerator (2°C to 8°C, 36°F to 46°F).
•
An unopened cuvette pouch is stable when stored at 2°C to 8°C until the date printed on the pouch.
Unopened cuvette pouches may be stored at room temperature for 60 days. Once the pouch has been
opened, the cuvette must be used within 16 hours.
Cuvette or Tenderlett Disposal
The ProTime cuvette and Tenderlett Plus are for single use only and are not to be reused. After use they
contain human blood and should be disposed of in accordance with local regulations for human blood
contaminated waste.
INSTRUMENT SPECIFICATIONS
Size
Weight
Operating Temperature
PT Test Temperature
Battery Type
Operating Time On Battery
2.77 (h) x 4.5 (w) x 8.75 (l) inches
1.6 pounds
Room temperature (15°C to 30°C, 59°F to 86°F)
37±1.0°C
Nickel Metal Hydride (NiMH)
Approximately 2 hours (constant run), or 10 complete test
cycles per charge. Tests may also be run while ProTime is
plugged into AC/DC power module.
Anticipated Battery Life
100 - 240 VAC Power
Supply/Charger
500 charges
Input: 100 – 240 volts AC, 47 - 63 Hz
Output: 15 volts DC, 2.0 A
SERVICE AND MAINTENANCE
Routine Maintenance and Cleaning
DO NOT immerse the ProTime instrument or allow fluid to enter the cuvette housing. Inspect and clean
the outside of the cuvette slot as required. Remove residual dried blood or other foreign matter on the
outside of the instrument using gauze dampened with a 10% dilution of household bleach in water or with
gauze dampened with isopropyl alcohol or other disinfectant. DO NOT use other solvents or strong cleaning
solutions as they may damage the plastic components of the instrument.
Servicing The ProTime Instrument
Other then replacement of the rechargeable battery as described in this manual, the ProTime instrument is
not user serviceable. Should service be required, please contact Technical Support at 1-732-548-5700,
1-800-631-5945, or e-mail us at techsupport@itcmed.com. If you are advised to return the instrument to
ITC for service or repair, prior to shipping please clean the instrument, as described above.
Instrument Disposal
If instrument disposal is required, follow local regulations for the disposal of electronic devices. For battery
disposal, see the Battery Replacement section.
Battery Information
The ProTime Microcoagulation System is designed to run either on AC power supplied by the AC/DC power
module or on the rechargeable battery supplied within the unit.
7
Rechargeable Battery Facts
•
Batteries discharge naturally over time (approximately 5% per month).
•
Battery capacity (the amount of charge the battery will hold) is lower at low temperatures.
•
Batteries that are charged to their maximum capacity will generate heat if they continue to be charged.
•
The ProTime instrument uses a rechargeable NiMH (Nickel Metal Hydride) type battery. The maximum
capacity of any rechargeable battery will gradually decrease over time. To ensure maximum life of the
rechargeable battery, read and follow the information in Care of the ProTime Battery for Maximum
Life section.
Care of the ProTime Battery for Maximum Life
A new instrument, an instrument that is used infrequently, or an instrument with a new replacement
battery, should be plugged in for at least 8 hours before use to ensure that the battery is completely charged.
The instrument screen will show CHARGING BATTERY when the AC/DC power module is connected to the
AC power cord and the ProTime instrument. The screen will show CHARGE COMPLETE when the battery is
fully charged. The AC/DC power module should be disconnected after the CHARGE COMPLETE message is
seen. The AC/DC power module that has been supplied by ITC has been selected specifically for use with
your ProTime Microcoagulation System. Do not use any other AC/DC power module.
When the battery indicator on the screen shows less than 25% charge remaining, please refer to the
Charging the Battery section for instructions. To maximize battery life, allow your ProTime instrument to
discharge completely before re-charging. Avoid charging the ProTime instrument for frequent, short
periods of time (such as charging for a few minutes, removing from the AC/DC power module, and then
recharging again). Avoid storing and charging the ProTime instrument at extreme temperatures.
Built-in ProTime Battery Features
The ProTime instrument will shut off after 5 minutes if left unattended in order to preserve the battery
charge. If the instrument shuts off automatically, press the
button to re-start the instrument. Before the
start of each test, the ProTime instrument checks the amount of battery charge. If there is not enough
charge in the battery to run a test, the ProTime screen will display PLEASE CHARGE IT. If this occurs, follow
the charging instructions located in the Charging the Battery section. Whether or not the batteries are
charged, you may continue to run tests once the ProTime instrument is plugged into its AC/DC power
module.
Battery Replacement
Refer to the instructions provided with the replacement battery. The used battery should be disposed of in
accordance with local regulations for NiMH batteries.
8
SPECIMEN COLLECTION
Fingerstick whole blood is the recommended specimen. The Tenderlett Plus device is to be used with the
ProTime cuvette, and the Tenderlett Plus LV (low volume) device is to be used with the ProTime3 cuvette.
The Tenderlett Plus device will collect approximately 65 µL of blood (approximately 3 drops), while the
Tenderlett Plus LV device will collect approximately 27 µL of blood (approximately 1 large drop). Samples
should be analyzed immediately after collection. No additional sample preparation is required.
For venous samples, collect venous whole blood into an anticoagulant-free plastic syringe in place of
fingerstick sampling steps 3 and 4 of the Test Procedure section. Immediately dispense venous sample
into the Tenderlett Plus collection cup, filling the Tenderlett Plus collection cup. Follow instructions from
step 5 of the Test Procedure section.
Note: Serum, plasma or whole blood collected with any anticoagulants is NOT suitable
samples.
PREPARING THE INSTRUMENT
Unpacking and Inspection
1.
Remove any protective packaging that may be present around the instrument.
2.
Examine the packaging material to be sure that the AC/DC power module, AC power cord (see
note below), connecting cables, or other components have been removed. The materials that are
provided are listed below.
Note: Inspect each component for damage when unpacking. If damage is observed, contact
your ProTime representative.
Materials Provided
Article Quantity
ProTime Microcoagulation Instrument 1
ProTime Microcoagulation System Information and Training CD
(PROTIMEPRO only)
AC/DC power module – ITC Part No. IR5226
1
1
ProTime Microcoagulation Operator’s Manual 1
Note: An AC power cord is provided in the United States and Canada only. For use outside the
US and Canada, the customer must obtain a power supply cord that is internationally
harmonized and marked "<HAR>", 2-conductor, 0.75 mm
2
minimum wire, rated 300 V, with
a PVC insulated jacket. The cord and plug cap must be suitable for medical use. The cord must
have a molded on plug cap rated 250 V, 2.5 A.
Materials Needed But Not Supplied
•
ProTime cuvettes
•
Tenderlett Plus incision device
Optional Materials
Article
Personal Computer Interface Cable – ITC No. PROCABLE (ITC Part No. IR5313X)
Printer/Label Maker – ITC No. LBLKIT
Replacement Printer/Label Maker Interface Cable – ITC No. LBLCABLE (ITC Part No. IR5314X)
Replacement Battery – ITC No. PROBATTERY
9
Charging the Battery
The battery in the instrument needs to be charged before the first use.
1.
Connect the AC/DC power module to an electrical service outlet, using the AC power cord.
2.
Connect the DC power cord from the AC/DC power module into the DC port on the back of the
instrument. The instrument screen will show CHARGING BATTERY when the AC/DC power
module is connected to the AC power cord and the ProTime instrument. The screen will show
CHARGE COMPLETE when the battery is fully charged.
3.
Allow the battery to charge for at least eight hours.
TEST PROCEDURE
1.
Turn on the ProTime Instrument
Press the
button to start. The ProTime instrument performs a self-check procedure that may
take up to 60 seconds. ProTime will prompt you through the test. Watch the screen and follow
the prompts.
2.
Insert a Cuvette
Make sure the ProTime cuvette is brought to room temperature before use. Wait for the prompt.
Insert the cuvette into the slot with the printing face up and the bar-code down.
The WARMING screen will appear as follows:
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3.
Prepare for Finger Incision
While the cuvette is warming, prepare the finger. Wait for the prompt before incising the finger
and collecting blood.
It is easier to collect blood if the hands are warm. Follow these steps to ensure a good sample:
•
Wash the hands in warm water or rub hands together to stimulate blood flow.
•
Apply firm pressure to the palm and finger. Massage the hand and push blood into the
fingertips.
•
Cleanse middle or ring finger and dry. To prevent contamination, do not touch the site after
cleansing.
4.
Blood Collection
When this screen appears, it is time for the finger incision.
CAUTION: Blood collection must be finished within 2:10 minutes to prevent early
clotting of the sample. ProTime will keep time. If the 2:10 minute interval has expired
and the
button has not been pressed during this interval, a TIME OUT error message
is displayed. To run another test, repeat procedure from Step 2.
•
Place the Tenderlett Plus device firmly against the side of the finger. Place thumb on top of
the device as shown, and press the red trigger firmly using the other thumb.
•
Wipe away the first trace of blood.
•
Gently massage from the base of the finger to force blood to the tip so that a large drop of
blood forms.
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•
Touch the large drop of blood to the collection cup. Keep adding blood until the blood level
fills the cup above the line.
•
For Tenderlett Plus LV, ensure the cup is filled completely. Ensure the blood extends all
the way to the bottom of the cup. Add another drop if you are not sure you have
enough.
5. Snap Tenderlett Plus to ProTime
•
Hold the device at an angle and place the front end of the device into the slot in the
instrument.
•
Press down to click the Tenderlett Plus in place. You should hear a soft click.
6. Start the Test
•
Press the button to start the test. This signals ProTime to draw the sample into the
cuvette.
Note: Proper engagement of the
Tenderlett Plus to the cuvette is
critical to prevent a sample error.
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