ProTime Operators Manual

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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.

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SYSTEM FEATURES

1) Tenderlett

2) ProTime Cuvette

3) Display Panel

4) MENU/SCROLL

Button

5) START/SELECT

Button

6) Cuvette Entry Port

7) AC/DC Power Module

8) Input DC Port

9) Output Data Port

1.

2.

3.

4.

5.

6.

7.

8.

9.

Tenderlett Plus/Tenderlett Plus LV. The finger incision and blood collection device used with

ProTime and ProTime cuvettes.

ProTime/ProTime3 Cuvette. The cuvette performs the PT test.

Display Panel. The display panel prompts you through the test procedure, displays results and error

messages.

MENU/SCROLL Button. The button is used to move through menu screens and to scroll through

results.

START/SELECT Button. The button is pressed to turn ProTime on and off, to start the test and to

select menu items.

Cuvette Entry Port. The cuvette entry port accepts only ProTime and ProTime3 cuvettes.

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.

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.

Output Data Port. Use this port to download records in the ProTime memory.

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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

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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:

< 0.6

0.6 - 0.79

0.8 - 7.0

7.1 - 9.9

10.0 - 12.0

> 12.0

Then ProTime displays:

INR LOW

INR < 0.8

Result

Result - followed by "*"

INR > 9.9

INR HIGH

•

Results may be affected in patients receiving supra-therapeutic 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.

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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

2.77 (h) x 4.5 (w) x 8.75 (l) inches

Size

1.6 pounds

Weight

Room temperature (15°C to 30°C, 59°F to 86°F)

Operating Temperature

37±1.0°C

PT Test Temperature

Nickel Metal Hydride (NiMH)

Battery Type

Approximately 2 hours (constant run), or 10 complete test

Operating Time On Battery

cycles per charge. Tests may also be run while ProTime is

plugged into AC/DC power module.

500 charges

Anticipated Battery Life

Input: 100 – 240 volts AC, 47 - 63 Hz

100 - 240 VAC Power

Output: 15 volts DC, 2.0 A

Supply/Charger

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.

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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.

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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)

1

AC/DC power module – ITC Part No. IR5226

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 mm2 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

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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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5.

•

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.

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.

Note: Proper engagement of the

Tenderlett Plus to the cuvette is

critical to prevent a sample error.

6.

Start the Test

• Press the button to start the test. This signals ProTime to draw the sample into the

cuvette.

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•

It takes only a few seconds for ProTime to draw the blood into the cuvette. Watch the

screen for the next prompt.

7. Remove Tenderlett Plus

Remove Tenderlett Plus immediately when prompted to do so.

CAUTION: Failure to do so will result in an error message. ProTime allows you six

seconds.

•

•

Do not press the button after the Tenderlett Plus is removed from the ProTime

instrument while you are testing your INR. This will interrupt the test procedure, and you

will have to start over with a new blood sample.

The instrument then progresses to the test and displays the TESTING screen.

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8.

Read the Result

In a few minutes, the result is ready.

•

•

Press the button to turn off.

Press the button to go to the MAIN MENU if you want to run another test, review the data

in memory, print results, transfer results to a computer, or perform set up functions.

Notes:

• The result remains displayed for 5 minutes or until the button or the button is pressed.

• If the cuvette has not been removed and the instrument is left unattended for 5 minutes, the

instrument will display the following messages before shutting down and powering OFF:

What Does the Result Mean?

The result indicates the clotting activity of blood. When ProTime is used as a self-testing instrument, the

healthcare provider may program ProTime with the upper and lower limits that are right for the patient. In

this case, ProTime will display OTR if results are outside of the therapeutic range. The OTR will not display

if results are within the limits. If no limits are set, ProTime will display only the result.

Note: If OTR (Out of Therapeutic Range) appears after the INR result, the result is out of the

therapeutic range (TR) limits that have been preset by the professional (see the For

Professionals Only – Program Mode section).

TROUBLESHOOTING

Most often, an error message indicates a problem with blood collection or a mistake in the test procedure. If

an error message appears, read the instructions again and repeat the test with a new cuvette. The

Troubleshooting Guide section gives the messages for the most common errors with possible causes and

solutions.

As with all diagnostic tests, the 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.

If you get a persistent error, write down the error message and call ITC Technical Support at

1-732-548-5700, 1-800-631-5945, or e-mail us at techsupport@itcmed.com.

Please have the ProTime serial number and cuvette lot number ready when you contact ITC Technical

Support.

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Troubleshooting Guidelines

• Become skilled at obtaining blood with the fingerstick technique. This will help avoid sample errors.

• Follow all of the directions on the screen for optimal operation.

• Do not try to hasten the test process by performing the fingerstick while the WARMING screen is

displayed, as blood may clot before it is drawn into the cuvette and an error may occur. FOLLOW THE

INSTRUCTIONS ON THE SCREEN.

Troubleshooting Guide

Screen Display

Source of Error

INR HIGH

REPEAT TEST

IF SAME, CALL MD

Patient’s PT result is too

high (INR >12.0)

INR LOW

REPEAT TEST

IF SAME, CALL MD

Patient’s PT result is too low

(INR < 0.6)

Repeat the test. If it occurs again,

patient should be referred to their

physician IMMEDIATELY and re-tested

at the lab.

ON-BOARD QC

OUT OF RANGE

TRY AGAIN

Level I or II control is too

high or too low

Repeat the test. Check for adequate

storage of cuvettes or sampling

technique. Confirm results with the

lab.

NO CLOT DETECTED

REPEAT TEST

IF SAME CALL MD

At least one channel did not

clot

Repeat the test. If it occurs again,

patient should be referred to their

physician IMMEDIATELY and re-tested

at the lab.

TIME OUT

TRY AGAIN

Time ran out before starting

test

Test again with new Tenderlett Plus

and a fresh fingerstick. You may reuse

the cuvette if no blood was in contact

with the cuvette.

TEST INTERRUPTED

TRY AGAIN

Cuvette removed or operator

interrupted test

Review correct procedure. Repeat test.

SAMPLE NOT SEEN

TURN OFF

TRY AGAIN

Can be caused by small

samples, clots, air bubbles,

or a seal problem in one or

more channels

Check for proper collection technique.

Verify cup is completely filled. Use

another cuvette.

SAMPLE TOO LARGE

TURN OFF

TRY AGAIN

Sample oversize

Review directions and repeat the test.

SAMPLE TOO SMALL

TURN OFF

TRY AGAIN

Sample undersize

Repeat test. Exceed the fill line on the

cup to ensure sample size.

SAMPLE ERROR

TURN OFF

TRY AGAIN

Incorrect fluid movement

Air bubble detected in one

or more of the channels

Turn off and on again and repeat test

with new cuvette and fresh fingerstick.

15

Method of Control

Repeat the test. If it occurs again,

patient should be referred to their

physician IMMEDIATELY and re-tested

at the lab.

Page 16

Screen Display

Source of Error

Method of Control

Check to make sure cuvettes have not

expired. The expiration date is located

on the packaging and alongside the

barcode on the cuvette.

CUVETTE EXPIRED

Expired cuvette

BARCODE ERROR

REMOVE CUVETTE

TRY AGAIN

Instrument cannot read

barcode accurately

Visually inspect barcode. If scratched,

discard cuvette. If dirty, wipe clean. If

barcode is good, review correct

procedure and repeat test.

BATTERY ERROR

TURN OFF

TRY AGAIN

Power supply battery error

Repeat the test. If it occurs again,

replace the battery. If problem

persists, call ITC Technical Support.

INSTRUMENT ERROR

TURN OFF

TRY AGAIN

Instrument set up, data log

or communication error

Repeat the test. If problem persists,

call ITC Technical Support.

CHARGE ERROR

TURN OFF

TRY AGAIN

Power supply error

Check the AC/DC power module,

repeat the test. If problem persists,

call ITC Technical Support.

TEMP ERROR

TURN OFF

TRY AGAIN

Temperature not in range

Check for proper operating

temperature. Repeat the test. If

problem persists, call ITC Technical

Support.

PHOTO ERROR

TURN OFF

TRY AGAIN

LED blocked or other photo

system error

Repeat the test. If problem persists,

call ITC Technical Support.

MAIN MENU OPTIONS

The options presented in the MAIN MENU are:

Each of these options will lead to sub menus within the selection. The following buttons are used to navigate

the menu:

• The button is used to move the highlight bar to select the option.

• The button is used to select the option that is highlighted.

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Run Test

To run the test, select the RUN TEST menu item. The instrument does a SELF CHECK procedure, which

may take up to 60 seconds. The following screen is displayed for this period of time:

The test sequence continues as described in the Test Procedure section.

When the test completes, the result will appear as one of the following screens, depending on PID/OID

selections (see SET UP below).

Note: “X” is used for illustrative purposes only in the following examples.

If PID is ON and OID is ON:

If PID is OFF and OID is ON:

If PID is ON and OID is OFF:

If PID is OFF and OID is OFF:

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RUN LQC

When RUN LQC is selected from the MAIN MENU, the following screen is displayed and the user can select

NOR/ABN (NORMAL/ABNORMAL).

The instrument performs SELF CHECK procedure which may take up to 60 seconds. The testing proceeds as

described above except that no prompt for PID will be shown for a QC test, whether PID is ON or OFF.

When the test completes, the result will be displayed as follows, depending on OID ON/OFF and LQC

NOR/ABN selection:

NOTE: The result and ID information will be stored in the database as a QC record.

For LQC Normal with OID on:

For LQC Normal with OID off:

For LQC Abnormal with OID on:

For LQC Abnormal with OID off:

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SHOW RESULTS

Press the button to move the highlight bar to the SHOW RESULTS line on the MAIN MENU.

Press the button to view the SHOW RESULTS menu and observe the following screen:

DATA HISTORY

Press the button to view the most recent result in the DATA HISTORY memory. The instrument memory

holds 50 results. Pressing the button will scroll through individual results. The results are stored in

memory from the most recent to the oldest. Press the button to return to the MAIN MENU.

PATIENT RECORDS

The result and ID information will be stored in the database as one of the following screens depending upon

the PID/OID ON/OFF selections:

Note: “MM/DD/YYYY” and “HH:MM” are used for illustrative purposes only in the following

examples of date and time screens.

If PID is ON and OID is OFF:

If PID is OFF and OID is OFF:

If PID is ON and OID is ON:

If PID is OFF and OID is ON:

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LQC RECORDS

The result and ID information will be stored in the database as a QC record. QC result will be displayed as

follows, depending upon the OID ON/OFF selections and the LQC NOR/ABN selections.

For LQC Normal with OID on:

For LQC Normal with OID off:

For LQC Abnormal with OID on:

For LQC Abnormal with OID off:

PRINT DATA OR SEND DATA

Press the button to move the highlight bar to the SHOW RESULTS line on the MAIN MENU. Then press

the button to view the SHOW RESULTS menu and observe the following screen:

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The instrument auto send feature allows transmitting of test results directly to a serial printer or to a

computer by using the PROCABLE. Contact ITC Customer Service to order the PROCABLE.

To use the AUTO SEND feature, press the button on the PRINT DATA or SEND DATA display until AUTO

SEND is highlighted. Press the button and, depending on the current settings in the instrument, one of

the following displays will appear.

Example: Printing Data

Press the button to set the feature to ON or OFF and then press the button to save the setting.

• Highlight the SHOW RESULTS line in the MAIN MENU.

• Press the button to view the SHOW RESULTS menu.

• Press the button to move the highlight bar to the PRINT DATA or SEND DATA line.

• Press the button to access the PRINT DATA or SEND DATA option and select THIS RESULT or ALL

RESULTS option in the PRINT DATA or SEND DATA screen.

Upon selecting THIS RESULT, the last recorded test is sent from the instrument memory to a printer or to a

computer. If ALL RESULTS is selected, all results (up to 50) are printed/sent from the instrument memory

to a printer or to a computer. If MAIN MENU selection is made, the user is returned to the main menu.

Note: If the AUTO SEND feature is on, results will be automatically sent if the PROCABLE is

connected prior to the start of a test. To use a laser printer, the data must first be transferred to

an IBM-compatible personal computer and the results can be printed from that computer. The

following screen displays until the PRINT DATA or SEND DATA process is complete:

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SET UP

Go to the MAIN MENU screen and choose the SET UP option by using the

button to select SET UP. The following screen appears:

button to scroll and the

SET LANGUAGE

Press the button to select SET LANGUAGE. The following options are displayed when SET LANGUAGE is

selected:

Highlight a language selection and press the button to set it.

Note: English will be highlighted as the default language in a new instrument. After changing

the language, the new language becomes the default. The instrument will automatically turn

off after changing the language selection.

SET TIME / DAY

Select SET TIME/DAY from the SET UP menu. The following screen is displayed:

12 HOUR – MM/DD will be highlighted as a default selection. Highlight your TIME-DAY preference, then

press the button.

Note: In the case of a 24 HOUR selection, AM/PM acronyms will not appear on the screens.

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Changing the Hour

The time is pre-set to Eastern Standard Time (EST). For example, the time is 1:25 PM. Change the hour by

pressing the button until the correct hour appears in the highlight bar. In this example, the correct hour

is 10 AM. To change the hour, press the button until 10 AM appears in the highlight bar. The PM

changes to AM at midnight. Once the correct hour appears, press the button to set the hour. The

procedure will then advance to the MINUTES screen.

Changing the Minutes

The hour on the top line has changed to the time just set and PM has changed to AM.

Change the minute by pressing the

button until the correct minute appears.

Once the correct minute appears, press the button to set the minutes. The procedure will then

automatically advance to the DAY screen.

Changing the Day

Only the day can be changed. The month and year can be changed only in PROGRAM MODE. Change the

day by pressing the button until the correct day appears. Once the correct day appears, press the button

to set the day.

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SET PID/OID

The PID/OID selection is indicated only by the location of the highlight (text on the screen is unchanged).

• Use the button to select PID/OID options:

•

•

•

•

Selecting PID/OID ON enables both a patient ID and operator ID to be entered.

Selecting PID ON enables only a patient ID to be entered.

Selecting OID ON enables only an operator ID to be entered.

Selecting OFF disables both a patient ID and operator ID.

Note: The selection is highlighted and remains the default until changed again by the user.

Entering and Changing Numerical Information (PID/OID, PASSWORD)

By using a combination of the button and button and the triangular cursor on the display screen,

numeric information can be entered into the instrument for operator identification number (OID), patient

identification number (PID) and PASSWORD fields. When entering numeric information into a field,

pressing a button has the following actions:

•

CHANGE - Pressing the button once will increment the digit in the current cursor position by

one, starting at 0 and going through 9 and back to 0 again.

•

OK - Pressing the button briefly enters the digit displayed in the current cursor position and then

moves the cursor right, to the next field position. Pressing the button for 2 seconds or longer saves

the complete numeric field.

EXAMPLE: Entering a PID number:

With the PID feature enabled, the following screen appears after a cuvette is inserted into the instrument:

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To enter a PID, the first position in the PID field (starting from the left) is indicated by a triangular cursor.

• Press the button until the desired digit is displayed.

• Press the button briefly to enter the digit in that position of the field. The cursor will automatically

move to the next field position.

• Repeat these steps until the desired field length is entered.

• To save the entered PID value press and hold the button for approximately 2 seconds until the

second audio beep is heard.

Note: These audio beeps will be heard regardless of BEEP setting (ON/OFF).

After the cuvette is inserted, the user has the option to set an operator ID (OID) and/or a patient ID (PID) if

the OID and/or PID have been enabled in the SET UP section of the MAIN MENU. The PID may contain up

to twelve digits, the OID can be a value with up to six digits.

Note: In the different scenarios related to SET PID/OID ON/OFF settings, some of the following

four screens are not presented to the user. For example, none of these four screens will appear

if both PID and OID are set to OFF value. The default numerical PID and OID values are zero.

If OID is set to the ON position, the following screen will appear:

Use the and buttons to move the cursor and to enter the numeric ID.

The CONFIRM OID confirmation screen will follow the ENTER OID screen:

If button is pressed, the user will return to the previous screen, otherwise (if the button is pressed and

PID is set to the ON position) the program will proceed to the following ENTER PID screen:

Use the and

buttons to move the cursor and to enter the numeric ID.

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