ProTime Operators Manual

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 [email protected]. 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

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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 [email protected]. 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.

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Method of Control Repeat the test. If it occurs again, patient should be referred to their physician IMMEDIATELY and re-tested at the lab.

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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