Changing the Day Only the day can be changed. Change the day by pressing the button until the correct day appears. Once the correct day appears, press the button to set the day. Note: The selection is highlighted and remains the default until changed again by the user.
Pressing the button for 2 seconds or longer saves the complete numeric field. The cursor will automatically move to the next field position. Note: Regardless of BEEP setting, the beep will sound under the following conditions: power on, power off, and following a key hold. The default password in a newly manufactured instrument is , which the user can then change to a password of their own choosing see the Change Password section. The procedure will then advance to changing the year screen.
Change the year by pressing the button until the correct year appears. Once the correct year appears, press the button to set the year. The following screens appear for selection of the upper and lower TR limits. Set upper limit by pressing the button until the desired upper limit is displayed.
Select the limit using the button. The upper limit can be set to one of eight values ranging from 2. Once the upper limit is set, the lower limit will be available for setting. Set lower limit by pressing the button until the desired lower limit is displayed. The lower limit can be set to 0. If limits are not changed, the instrument will use its default limits 9.
If the ISI of the reagent used in the local facility is significantly different from 1. Press the button to set. The values used for the normal control population change as the theoretical ISI is changed.
The normal control population values are determined from clinical data. The rules for entering a numerical PID or OID are also applicable for entering the 6 digit numerical password see page Note: Upon manufacturing, the default password is set to To prevent accidental loss of data, the following confirmation screen will precede the data removal from the instrument memory: Selecting NO will return the instrument to the MAIN MENU, and no results will be erased from the instrument memory.
The ProTime system calculates the INR directly from whole blood clotting time based on a conversion equation that was established in clinical trials. The result in plasma equivalent seconds is then calculated from the INR result. Historically, laboratories have reported prothrombin time results in seconds, specifically the time it takes for the plasma sample to clot following the addition of the reagents.
Reporting the results in seconds is problematic since the clotting time depends on the sensitivity of the reagent used. Results cannot be compared from one laboratory to another.
The ISI value ranges from 1. A low ISI indicates that the reagent has the highest sensitivity to vitamin K-dependent clotting factors. Typically, the variable PTn is generated by the laboratory with each new reagent lot by running 20 samples and calculating the mean. The ProTime system enhances clinical utility for the physician and patient by providing results in both formats, so that anticoagulant dosing can be managed using a familiar format.
Since results reported in PT seconds depend on the sensitivity ISI of the reagent employed, the physician has the option of changing the ISI value in ProTime so that the ProTime results reported in PT seconds closely match the results reported by the hospital laboratory.
To change the ISI used in the calculation, the physician simply accesses the programming screens and enters the ISI of the historical laboratory reagent.
Table 1. Expected Values ProTime measures both normal and therapeutic prothrombin times in fresh whole blood. Results are displayed in plasma equivalent seconds and INR. The default ISI used in this calculation is 1. The ProTime instrument has been tested extensively by doctors, nurses and patients.
Eighty-four people, ages 7 to 81, participated in the first home-use trial. The trial was conducted to see how well ProTime results compare to the lab. Comparisons of this type are described by correlation values and a correlation value near 1. The home tests compared to tests run at the clinic using ProTime with venous samples samples had a correlation of 0. The home test results compared to a reference laboratory results samples had a correlation of 0. These correlation values mean that home testing is comparable to lab testing.
Precision Precision testing was conducted with two levels of standard control plasma substrate preparations Level I and Level II. The following accuracy data was obtained. Standard ProTime Cuvette vs. ProTime3 Cuvette vs. ProTime3 vs. ProTime Professional vs. Quality Control The ProTime instrument has been designed with multiple systems to ensure proper instrument function.
The instrument self-check at startup checks temperature and timing functions, battery level, and optical, electrical and mechanical functions. The instrument does not require further calibration. Each ProTime cuvette has two integral reagent controls that ensure assay reliability and performance. Both levels of control produce quantifiable clotting endpoints that are compared to pre-set acceptance limits programmed in the instrument.
Other in-process instrument QC features and the integral reagent controls function together to ensure correct sample size and collection technique, correct test procedure, instrument functionality and reagent integrity. A fault message is displayed instead of PT results when any instrument or reagent quality criterion is not met. When a fault message is displayed, the user should review the product instructions and repeat the test.
Each institution should establish a quality assurance program for prothrombin time testing that complies with existing local, state and federal regulations as applicable.
Effect of 3. Am J Clin Pathol ; Calculation vs. N Engl J Med ; Arch Pathol Lab Med ; Thromb Haemost ; Hirsh J. Am Heart J ; Hirsh J, Poller L. The International Normalized Ratio. A Guide to Understanding and Correcting its Problems. Arch Intern Med. Br J Haematol. Hemorrhagic Complications of Anticoagulant Treatment. CHEST ;ss. Technical Assistance For further information and technical assistance, call ITC Technical Support at , , or e-mail us at [email protected] Ordering Information For further information on ordering and supplies, contact your ProTime distributor.
Rather, it is intended to indicate that the instrument is not suitable for use in the direct presence of a flammable anesthetic mixture with air, oxygen or nitrous oxide. All relevant documentation is kept on file at ITC. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players. Search FDA. Food and Drug Administration. For Government For Press. Adverse Events. CFR Title Radiation-Emitting Products. X-Ray Assembler. Note: The 0 zero key is used as both a numeral key and an action key.
Display the number of patient or QC test results that are currently stored in the. Print results on an external printer for the last test result, patient database, quality. Enter numeric information e. The instrument communicates with the operator by means of the display panel. The display is illuminated to enhance visibility in low light conditions.
To conserve power during battery operation, the display is not illuminated when the test well is empty or when a test is running. The display is momentarily illuminated after a key is pressed or when results of a completed test are displayed. The action keys display the various commands for operating and configuring the system. Display a menu by pressing the corresponding action key. Display each command on a menu by pressing the action key again or the zero key.
Execute a command by pressing the ENTER key while the command is displayed or by pressing the numeric key for that option when the menu is displayed. The commands displayed after successive keystrokes on each action key are summarized below:. If not in use, the instrument will automatically shutdown after five minutes. Each test cuvette contains a label , a sample well , a test channel containing reagents, an enclosed waste reservoir , and optical detection windows.
The cuvette label is humanand instrument-readable. The current test is automatically read by the instrument and displayed for confirmation when the operator inserts the cuvette into the test chamber. These are summarized below:. If one or more of these lockouts is enabled, processing of the lockout s occurs before any other instrument functions. The instrument will sound one short beep when pre-warming is complete. A test terminates and operation of the test chamber automatically shuts off if clot formation is not detected within a test-specific, preset maximum time.
Note : Results that are greater than the time noted in the package insert for a test are beyond the sensitivity range of the test. They should be repeated immediately and, if confirmed, reported as greater than the maximum sensitivity range. The instrument is also self-calibrating, as all instrument functions are continuously monitored and verified by the instrument software when a test is performed.
The instrument does not require additional calibration by the user. Note : Inspect each component for damage when unpacking. If damage is observed, contact your shipper or service representative immediately.
Remove any protective packaging that may be present around the instrument. Examine the packaging material to be sure that the power supply, connecting cables or other components have been removed. The materials that are provided are listed below. HJ; see Connecting a Computer or. Allow the battery to charge for at least 16 hours. Press 0 zero to display the main menu:.
Press 1. The battery status is displayed:. The time and date a test is run is saved with the test results. The system time and date can be reset by the operator unless the system is in a lockout condition or the time and date are permanently locked see the.
Configuration Manager section on page Note : If the unit has been off for an extended period of time or the battery is very weak, the operator will be prompted to enter or verify that the time and date are correct.
Press 2 to display the time:. TIME: Enter the new time using the numeric keys. Note : Use the hour format i. The leading zero is required for single digit times i. Press 3 to display the date:. Type the new date using the numeric keys. Note : Use the European i. The leading zero is required for single digit dates i.
The connector port for these devices is located at the side of the instrument. Obtain a printer interface cable. For additional information on printer configuration, contact ITC Technical Service at or , or by e-mail at techservices itcmed. Connect one end of the cable to the connector port on the side of the instrument. Connect the other end of the printer cable to the printer.
Obtain a computer interface cable. Note: The computer interface cable is included with the instrument.
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