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PERFORMANCE CHARACTERISTICS

Please refer to the test strip labeling for detailed information on

test limitations and analytical performance.

Accuracy

Within ±15 mg/dL (0.83 mmol/L) at glucose concentration < 75

mg/dL (4.2 mmol/L) and within ±20% at glucose concentration ≥

75 mg/dL (4.2 mmol/L).

Precision

The coefficient of variation (CV%) of intermediate precision and

repeatability are less than 5%.

This product has been tested to meet the requirements of ISO 15197.

Содержание POCT S10a

Страница 1: ...nt This POCT system also reduces risks of operator errors and allows one hand operation by hospital professionals through simple steps Integrated barcode scanning helps reduce the risk of manual data...

Страница 2: ...e using this product to test blood glucose read all instructions thoroughly and practice the test Do all quality control checks as directed 8 Always wear gloves when performing tests and follow your f...

Страница 3: ...for testing multiple patients when Standard Precautions and the manufacturer s disinfection procedures are followed Please refer to section Taking Care of the Meter Strips for cleaning and disinfectio...

Страница 4: ...es for Control Solution Testing 16 Control Test Procedure 17 PATIENT TEST 20 Collecting Blood Samples 21 Patient Test Procedure 22 Results Indicators 25 MEMORY MODE 26 Reviewing Test Results 26 Review...

Страница 5: ...5 TAKING CARE OF THE METER STRIP 37 Disinfecting Procedures 38 Storage 40 ERROR MESSAGES 42 SPECIFICATIONS 43 Performance Characteristics 44...

Страница 6: ...important things to remember Before performing patient tests please read this Operator s Manual carefully The ForaCare POCT S10 Blood Glucose Monitoring System must be properly set up configured befo...

Страница 7: ...m includes the following items 1 2 3 4 5 6 7 1 2 3 4 5 6 7 Note 1 Please make sure that all components listed above are included in the kit before using this system If you find any of these missing or...

Страница 8: ...11 12 13 USB port for mini USB cable LCM Panel Up Button Down Button Barcode Scanner Recharge Indicator Battery Compartment Scan Button Return Button Strip Ejection Button Reset Key On Off Button Numb...

Страница 9: ...lect each mode simply by pressing Up button or Down button and enter the desired mode by pressing S button Main Menu Measure Mode Test Results Y1 All QC Record All Record Setting Unit Operator Record...

Страница 10: ...ood has been applied to the absorbent hole of the strip Test Strip Handle Hold this part to insert the test strip into the slot Contact Bars Insert this end of the test strip into the meter Push it in...

Страница 11: ...ed When the battery is low a battery symbol will display on the screen which means it is about time to recharge the battery For example To recharge the battery please connect the USB cable to the USB...

Страница 12: ...ay Setting Date press S button to the next step Press Up Down button to select the desired date expression Press S but ton to the next step Press Up Down button to select the desired year month or day...

Страница 13: ...test strip It is necessary to take this action before you proceed to the testing Failure to do so may lead to inaccurate test results Press Up Down button to select the desired hour and minute Press...

Страница 14: ...rainees will be come proficient operator to access Measure Mode Training 1 Press the On Off button to turn on the meter and select setup mode 2 Press Up Down button to select Training Mode then press...

Страница 15: ...via a USB cable For detailed information about the POCT Management System please refer to ForaCare POCT Management System Operator s Manual Note If the examinee passes the evaluation he she will becom...

Страница 16: ...quality control results when using ForaCare POCT S10 Blood Glucose Monitoring System Only use the control solutions for ForaCare POCT S10 test strips When using a new bottle of control solution write...

Страница 17: ...ion lot number via the keypad 6 With the contact bars facing up insert the test strip into the test strip slot Note Note The Apply Sample screen will appear Users should follow local state and federal...

Страница 18: ...e sample and display the test result 9 Make sure the test result falls within the acceptable range Note The meter will produce a beep sound and then begin to count down The results will display on the...

Страница 19: ...r Strip Lot screen will appear Return to step 5 to repeat the test If you select QC for W2 control solution test you may perform the test by returning to step 4 10 Push up the Strip Ejection button an...

Страница 20: ...performance of Fora Care POCT S10 Blood Glucose test strips and meter Test strips should be used before their expiration date Do not use wet bent scratched or damaged test strips After the blood is ap...

Страница 21: ...Use only sodium heparin or EDTA as anticoagulants Apply blood to the absorbent hole of the test strip until the confirmation window is fully covered with blood Collecting Blood Samples WARNING To redu...

Страница 22: ...etup Mode QC Mode Measure Mode 12 59 AM 1 4 Note If the operator ID is invalid this indicates this operator has not passed the training test and is not recognized by the system The meter will display...

Страница 23: ...firmation window is fully covered with blood 5 Press S button to scan the Patient ID barcode or manually enter the Patient ID via the keypad 6 Press Up Down button to select Capillary Venous press S b...

Страница 24: ...ormation please refer to the Cleaning and Disinfection section Note Note The meter will produce a beep sound and then begin to count down The results will be display on the screen and automati cally s...

Страница 25: ...en 240 mg dL and 600 mg dL 13 3 mmol L and 33 3 mmol L P l e a s e s e e k i m m e d i a t e m e d i c a l assistance This indicates the blood glucose level is over the measurement limit 600 mg dL 33...

Страница 26: ...he following categories All Record This option displays all data Patient Record This will display the test results for a particular patient Operator Record This will display test results performed by...

Страница 27: ...and shut down automatically 3 If no test result is in the search category the message of Record not found will be displayed on the screen 1 Press the On Off button to turn on the meter 2 Press Up Down...

Страница 28: ...When finished viewing the data the operator can Press the Return button to return to the menu Press the On Off button to turn off the meter 2008 06 20 Setup Mode QC Mode Memory Mode 12 59 AM 3 4 Note...

Страница 29: ...the previous result 5 When finished viewing the data the operator can Press the Return button to return to the menu Press the On Off button to turn off the meter Note Note The screen displays the mos...

Страница 30: ...he previous result 5 When finished viewing the data the operator can Press the Return button to return to the menu Press the On Off button to turn off the meter Note Note The screen displays the most...

Страница 31: ...n to view the previous result 5 When finished viewing the data the operator can Press the Return button to return to the menu Press the On Off button to turn off the meter Note Note The screen display...

Страница 32: ...e three levels of control solution that can be retrieved by the following categories All QC Record This option displays all QC records Search by Level This will display test results of a particular co...

Страница 33: ...e following options Press Down button to view the next result Press Up button to view the previous result 4 When finished viewing the data the operator can Press the Return button to return to the men...

Страница 34: ...On Off button to turn off the meter Please refer to Memory Mode section for step by step instructions to access to the Memory Mode menu Note Note The screen displays the most recent QC test result fir...

Страница 35: ...the operator can Press the Return button to return to the menu Press the On Off button to turn off the meter Please refer to Memory Mode section for step by step instructions to access to the Memory M...

Страница 36: ...nstructions to access Memory Mode menu Note The screen displays a list of all proficient operators IDs 3 When finished viewing the data the operator can Press the Return button to return to the menu P...

Страница 37: ...ng wipe to clean exposed surfaces of the meter thoroughly and remove any visible dirt blood or any other body fluid with the wipe Use a second wipe to disinfect the meter by following the disinfecting...

Страница 38: ...tructions on the package label of disinfecting wipe Use two or more wipes if necessary 4 Remove the wipe Allow the meter surface to dry completely 5 Discard the used wipes and never reuse them 6 Remov...

Страница 39: ...omer service for a replacement meter if any of the signs of deterioration are noticed Note Do NOT clean and disinfect the meter while performing tests Do NOT allow cleaning and disinfecting solution t...

Страница 40: ...of transmission of blood borne pathogens please refer to FDA Public Health Notification Use of Fingerstick Devices on More than One Person Poses Risk for Transmitting Bloodborne Pathogens Initial Comm...

Страница 41: ...with clean dry hands Use each test strip immediately after removing it from the vial Write the discard date the date opened plus 3 months on the vial label when you first open it Discard remaining tes...

Страница 42: ...sert a new test strip and repeat test Error 008 Test strip was pulled out Please re insert the test strip Error 009 Low level control solution error Please scan low level control solution lot number a...

Страница 43: ...ment Range POCT S10 122mm x 64mm x 24mm 130g without battery One 3 7 V rechargeable Li ion battery 2000 test results and an additional of 500 sets of control solution testing data After idle for 3 min...

Страница 44: ...ical performance Accuracy Within 15 mg dL 0 83 mmol L at glucose concentration 75 mg dL 4 2 mmol L and within 20 at glucose concentration 75 mg dL 4 2 mmol L Precision The coefficient of variation CV...

Страница 45: ...45 MEMO...

Страница 46: ...46 MEMO...

Страница 47: ...47 MEMO...

Страница 48: ...48 MEMO...

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