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Appendix 1 Meter Specifications

Feature

Specifications

Methodology Optical

Fluorescence

Test Time

About 2 minutes

Measurement Range

0.7 to 7.0 INR (International Normalized Ratio)

Specimen

Capillary whole blood
Venous whole blood

Specimen Volume

Power Source

4 - AA (LR6) Alkaline Batteries
AC Adapter
Input: 100-240V



50-60Hz, 400mA

Output: 6.0V DC 0.85A

Battery Life

> 100 tests

Units of Measurement

INR, PT (seconds)

Memory 200

records

Automatic Shut Off

2 minutes after last operation

Meter Size

152 mm × 72 mm × 38mm

Display Size

53 mm × 29 mm

Weight

170 g (without batteries)

Meter Storage
Conditions

0 - 50ºC (32 - 122ºF);

≤

95% RH

Operating Conditions

15 - 35ºC (59 - 95ºF);

≤

90% RH

Meter Connectors

RS232 port for printer connection, mini USB port
for data transfer, and power adapter port

Содержание PT/INR

Страница 1: ......

Страница 2: ...2 Setting the Time 13 Sound 15 Meter Information 15 Display Language 16 INR Display 16 Password 17 Section 6 Testing 19 Fingertip Testing For Professional and Self Testing Use 19 Specimen Collection 2...

Страница 3: ...batteries or the included AC adapter Note It is required that the healthcare professional follows the Mission PT INR Monitoring System Training Manual to train the self testing patient before the pat...

Страница 4: ...The Mission PT INR Monitoring System can report results as INR or INR PT values in just a few minutes by simply taking a specimen of blood from a fingertip This information can then be used to adjust...

Страница 5: ...en insert a test strip into the meter detection area under the strip holder After a brief warm up time the specimen can be added to the test strip specimen application area When the specimen is added...

Страница 6: ...es below are labeled to identify the major components of the Mission PT INR Monitoring System PT INR Meter Code Chip Control Solution AA Batteries Plastic Clamp Capillary Transfer Tube Carrying Case A...

Страница 7: ...hat the PT INR Monitoring System is working properly Plastic Clamp Provided in each box of control solutions Used to break the glass ampoule inside the plastic control solution vial to release the wat...

Страница 8: ...chip is provided in each box of test strips The code chip needs to be inserted into the meter code chip slot each time a new box of test strips is opened The code number is printed on the outside of...

Страница 9: ...dicated by the label at the bottom of the display directly above the button All display functions are represented by English labels icons or numbers The Icons function is an alternative setting from t...

Страница 10: ...Displays the Code Chip Number Data Log To review previous test results Contrast Adjusts the display contrast Date Sets the meter date Time Sets the meter time Audio On Off Turns the meter sound on or...

Страница 11: ...he same as that printed on the test strip box and the same as the number shown on the meter test screen when a test strip is inserted Code Press the power button right button to turn the meter on The...

Страница 12: ...10 If there is no code chip in the meter when a test strip is inserted or there is a code chip error the following screen will be shown...

Страница 13: ...t at the top of the meter and press PRT EX The next screen will show the printing options of one log or ten logs One means printing the current displayed log while Ten means printing 10 consecutive lo...

Страница 14: ...the Display Contrast Select Contrast as shown in the screen below to adjust the display contrast Press the Up or Down buttons to increase or decrease the display contrast Press OK to save the setting...

Страница 15: ...shown Press OK to move the highlight to the day Press Up or Down to increase or decrease the setting until the correct day is shown Press OK to move the highlight to the year Press Up or Down to incr...

Страница 16: ...s Next to move the selection box between AM and PM until the time of day is correct Press OK to select the correct time of day as in the screen below The current hour setting will be highlighted Press...

Страница 17: ...isplay below The current Audio setting will be selected which is either Audio On or Audio Off Press Next to move the selection box between the Audio On and Audio Off setting When the desired setting i...

Страница 18: ...for icons When the desired setting is selected press OK to save the new setting and return to the previous menu selection screen Press Exit to exit this submenu without making any changes INR Display...

Страница 19: ...own buttons on each digit to increase or decrease the current flashing digit The OK button will advance the selection to the next digit until all four have been entered Possible password values range...

Страница 20: ...lear the password entered or turn off password protection enter the password saved then reenter the password with 0000 when Reenter Password screen is prompted The password will be cleared when OK is...

Страница 21: ...as described in Section 5 Meter Setup and Options Before turning the meter on insert the code chip which is found inside the box of test strips into the code chip slot on the right side of the meter...

Страница 22: ...ed Observe the display as the meter is turning on It will show a checkerboard alternating pattern as seen in the images below Make sure the pattern is regular with no missing light or dark areas in th...

Страница 23: ...t one After setting the patient ID the meter will prompt the user to close the optics cover by displaying the following screen If the meter detects that the optics cover is not closed within 6 seconds...

Страница 24: ...do not continue until the inserted code chip and the Code displayed on the meter are the same 1 Blood test 3 Control Solution test 2 Electronic Calibrator test 4 Code Number Press the left button unde...

Страница 25: ...axed before collecting the capillary blood specimen Use warm water to increase blood flow if necessary Massage the hand from the wrist up to the fingertip a few times to encourage blood flow Clean the...

Страница 26: ...ufficient specimen is applied Warning For a fingertip whole blood specimen if the test needs to be repeated do not use the same puncture or puncture site A new puncture must be made for each test to a...

Страница 27: ...is complete When the test is complete the results will be displayed in International Normalized Ratio units INR if the INR option was previously selected If the selected option is INR PT the results w...

Страница 28: ...ouch the tip of the Capillary Transfer Tube to the blood specimen Capillary action will automatically draw the specimen to the fill line and stop Note The Capillary Transfer Tube will fill automatical...

Страница 29: ...erfly collection set into a 3 ml syringe with no anticoagulants Remove the syringe from the butterfly tubing and allow 4 drops to fall onto a clean gauze pad to be discarded Apply a small hanging drop...

Страница 30: ...o ensure the test is being performed correctly The labels on the control solution bottles are printed with the acceptable range for the control INR results To ensure continued accuracy of results cont...

Страница 31: ...will allow selection of Level 1 Normal or Level 2 calibration values Press Lvl 1 for Level 1 test Lvl 2 for Level 2 test or Exit to return to the specimen testing screen If Lvl 1 or Lvl 2 were select...

Страница 32: ...el 2 High values If the Mission PT INR Monitoring System is working properly the INR value will be within the range of accepted values printed on the control solution pouch label Liquid control tests...

Страница 33: ...s through the plastic vial wall Tap the vial firmly 5 10 times so that the water dissolves the powder After tapping the vial set the vial down for later use Caution Liquid control solutions are made f...

Страница 34: ...een below or the countdown timer screen also shown below if the time to add control solution is less than 30 seconds away Applying the Control Solution When the displayed countdown reaches zero the me...

Страница 35: ...ics cover until the test is finished Interpreting Results When the test is complete the results screen will be displayed indicating the result is a Control Solution Test result If the result is within...

Страница 36: ...rrect date and time if necessary e g daylight savings time See Section 5 Change the batteries when necessary Keep the meter clean Replacing the Batteries Remove the included AA batteries from their pr...

Страница 37: ...e is thoroughly damp The meter surface must remain visibly wet for one full minute to effectively disinfect After disinfection please allow the meter to air dry completely before using it again When d...

Страница 38: ...e optics cover using the DisCide Ultra Disinfecting wipes as previously outlined The meter optics cover can easily be removed if it becomes contaminated or damaged The optics cover is designed to be r...

Страница 39: ...aligned with the strip holder grooves as shown below Slide the strip holder in until it snaps into place The meter is now ready for testing Caution To avoid the transmission of infectious diseases bet...

Страница 40: ...ting temperature range Compare your result with the desired target range set by a healthcare professional at specified intervals in order to verify your self testing performance An interval of six mon...

Страница 41: ...eter and used batteries Test Strip Use and Precautions Do not store test strips outside their pouch Test strips must be stored in their original strip pouch Once the pouch is opened use the test strip...

Страница 42: ...ication E4 Contaminated or dirty strip Check the test strip to ensure it is not used or contaminated Replace the test strip with a new one and test again E5 Insufficient specimen Applied specimen volu...

Страница 43: ...lace the batteries as soon as possible Strip removed during test Insert a new test strip Make sure to wait until prompted to remove the strip Low battery Low battery Replace the batteries before the n...

Страница 44: ...e Batteries AC Adapter Input 100 240V 50 60Hz 400mA Output 6 0V DC 0 85A Battery Life 100 tests Units of Measurement INR PT seconds Memory 200 records Automatic Shut Off 2 minutes after last operation...

Страница 45: ...Catalog Store between 2 30 C Lot Number Tests per Kit SN Serial Number Do not discard along with household waste This Side Up Fragile handle with care Keep Dry Keep away from sunlight and heat Do not...

Страница 46: ...ode chip error Memory Represents the meter data log memory to review the previous INR readings in chronological order Delete Log Deletes the meter data stored in memory LCD Contrast Adjustment Sets th...

Страница 47: ...own Up Key to move up Exit Key to Exit the menu Level 1 Level 1 EC Test Level 2 Level 2 EC Test Control Solution Test Control Solution Test Electronic Calibrator Electronic Calibrator OK Key to accept...

Страница 48: ...ntered password does not match the saved password Reenter Password Reenter the password Passwords do not match Password reentered does not match the previous password Password Cleared Password is clea...

Страница 49: ...to repair or replacement due to defects in parts or workmanship Parts required which were not defective shall be replaced at additional cost ACON shall not be required to make any repairs or replace a...

Страница 50: ......

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