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GLUCOFIX

TECH - 51415 - 02/20

Calibration and

traceability:

The results are equivalent to the plasma glucose concentration (capillary

plasma referenced). The GLUCOFIX

TECH system is calibrated using

capillary plasma values determined with a Yellow Springs 2300 analyser

(YSI). The YSI analyser is calibrated (as a secondary reference measurement

procedure) using a series of YSI standards (primary calibrators) which are

taken from the NIST (National Institute of Standards and Technology, USA)

Temperature

compensation:

Automatic compensation using a built-in thermo sensor

Batteries:

Two 3.0 V lithium batteries (CR2032)

Battery life:

A minimum of 1000 tests or about 1 year (2-3 tests/day)

Memory:

730 test results with markers, dates and times. When the memory is full, the

new results will replace the oldest ones

Data management: Before/after meals, exercise, check markers available
Alarms:

Up to three settable acoustic alarms

Data transfer:

Via dedicated data cable, NFC, or a Bluetooth device

Averages:

Over 1, 7, 14, 30, 60, 90 days

9. TECHNICAL SPECIFICATIONS

Содержание GLUCOFIX TECH

Страница 1: ......

Страница 2: ...0800 243667 Republic of Ireland 1800 709903 Northern Ireland 0800 7837286 This number is not for emergency or medical information E mail myglucomen menarinidiag co uk Web site www glucomen co uk Date...

Страница 3: ...iabetes This manual explains how to use your new meter Before testing carefully read through this manual and the package inserts that come with it GLUCOFIX TECH Sensor and GLUCOFIX TECH Control Pay pa...

Страница 4: ...d Warnings Notes provide helpful operating information Cautions provide information that is important for meter protection Warnings provide information that is important for user protection or about r...

Страница 5: ...aution when using the Test Strips 15 4 MEASURING YOUR BLOOD GLUCOSE LEVELS 16 4 1 Blood sampling 16 4 1 1 Alternative site testing AST 16 4 2 Testing your Blood Glucose 17 4 3 Control Test 19 4 4 Mark...

Страница 6: ...per alarms setup 31 6 5 NFC setup 32 7 METER CARE 33 7 1 Storing your meter 33 7 2 Cleaning your meter 33 7 3 Changing the batteries 33 8 TROUBLESHOOTING 36 8 1 HI and LO messages 36 8 2 Error message...

Страница 7: ...iabetes or for neonatal use Do not alter your treatment on the basis of test results of this meter without previously consulting your doctor or healthcare professional The meter complies with the requ...

Страница 8: ...GLUCOFIX TECH 51415 02 20 UK 8 2 SYSTEM OVERVIEW 2 1 GLUCOFIX TECH Meter TEST STRIP PORT UP DOWN BUTTONS ENTER BUTTON BATTERY HOLDER NFC ANTENNA DATA TRANSFER PORT RELEASE BUTTON FRONT BACK...

Страница 9: ...ultaneously press and for 2 seconds to enter setup menu while not testing 6 UP DOWN BUTTONS Press or to scroll through different options and or values RELEASE BUTTON Press this button to remove used t...

Страница 10: ...20 UK 10 METER SCREEN 2 SYSTEM OVERVIEW CLOCK ALARM ICON HYPO HYPER ICONS DROP ICON MAIN DISPLAY AREA UNIT OF MEASUREMENT TIME AVERAGE DATE MARKERS ICONS WRONG TEMPERATURE ICON MEMORY ICON CTL ICON NF...

Страница 11: ...low or above these values 6 4 DROP ICON Blinks to indicate that the meter is ready for blood or control solution testing 4 2 4 3 MAIN DISPLAY AREA Displays test results stored test values result avera...

Страница 12: ...rature range LOW BATTERY ICON Appears when the battery needs to be replaced 7 3 NFC ICON Displayed while setting the NFC Near Field Communication function 6 5 and when this function is enabled blinks...

Страница 13: ...se levels temperature 5 to 45 C 41 to 113 F humidity 20 to 90 RH Relative Humidity Do not store or use the meter where there are sharp temperature fluctuations humidity is high and causes condensation...

Страница 14: ...the test strip port on the meter Do not share your meter with anyone else to avoid the risk of infection The meter complies with applicable electromagnetic emission requirements EMC However do not per...

Страница 15: ...meter and test strips to adjust to the surroundings for at least 30 minutes before testing your blood glucose levels temperature 5 to 45 C 41 to 113 F humidity 20 to 90 RH After first opening the via...

Страница 16: ...e same lancet or lancing device with anyone else to avoid the risk of infection Always use a new lancet Lancets are for single use only Do not reuse a lancet that has already been used 4 1 1 Alternati...

Страница 17: ...cold sweats a floating sensation or trembling When immediate testing is needed for suspected hypoglycaemia When in poor physical condition such as with a head cold etc 4 2 Testing your Blood Glucose a...

Страница 18: ...reen CAUTION If LO or HI appears on the screen Repeat the test If LO or HI still appears contact your doctor or healthcare professional LO appears if your test result is less than 1 1 mmol L HI appear...

Страница 19: ...wnwards and away from others Disposal of Biohazardous Waste Used test strips and lancets are biohazardous waste They must therefore be disposed according to local regulations on biohazardous waste 4 3...

Страница 20: ...5 to 45 C 41 to 113 F humidity 20 to 90 RH Do not use the control solutions if 3 months or more have passed since first opening the vial Do not drink the control solution It is not intended for human...

Страница 21: ...e written in bigger characters on the main screen c Gently shake the control solution vial before testing Discard a drop before use Squeeze a drop of control solution onto a clean hard dry surface d T...

Страница 22: ...rip vial If out of range repeat the control solution test CAUTION If you still have test results that fall outside the acceptable range stop using the system and contact the A Menarini Diagnostics cus...

Страница 23: ...start blinking Press or to scroll through the icons backwards or forwards according to the following sequence Before meal marker After meal marker Exercise marker Check marker General Purpose marker...

Страница 24: ...e meter off hold for 3 seconds until the screen switches off b Press for 2 seconds to turn the meter on and enter the memory recall mode the mem icon appears on the screen c The most recent test resul...

Страница 25: ...memory recall mode step c of 5 1 f Hold for 3 seconds to switch the meter off NOTE If there are less than 2 results in the memory for the averaged period the screen displays ooo If there are no resul...

Страница 26: ...GlucoLog apps a Activate the NFC transmission on the GlucoLog app of the NFC equipped device b Bring the GLUCOFIX TECH NFC antenna close 1 cm to the antenna in the NFC equipped device NOTE Data will b...

Страница 27: ...ake sure the meter is off to turn the meter off press for 3 seconds until the screen switches off b Simultaneously press and for 2 seconds to enter the setup menu c Press or to scroll through the sett...

Страница 28: ...ext step year month day time format 12H 24H hour minutes After confirming the minutes by pressing return to the setting menus step c 6 NOTE Date is in the DD MM format 6 2 Alarm setup You can set up t...

Страница 29: ...larm section b The display will show alarm 1 status the default setting is OFF You can turn it on by pressing or to select the hour Press to confirm the selection and move on to the next step c Press...

Страница 30: ...r alarms setup Your GLUCOFIX TECH meter has an alarm feature that allows you to set your high hyperglycaemia and low hypoglycaemia blood glucose thresholds Based on the values set the screen will show...

Страница 31: ...e selection and move on to the hyper alarm setup e Press or to turn the hyper alarm ON OFF f Press to set the hyper alarm value if ON g Press or to select the desired value Press and hold either or to...

Страница 32: ...ot use test strips or control solutions if their bottles are broken or have been left open Do not use the test strips or control solutions after their expiry dates 7 2 Cleaning your meter Your meter d...

Страница 33: ...batteries as follows a Make sure the meter is switched off b Remove the battery cover at the rear of the meter c Remove the batteries d Fit the new batteries into the battery holder with the pole fac...

Страница 34: ...Improper use may cause explosion or leakage of flammable liquid Do not expose the battery to extremely high temperatures Do not expose the battery to extremely low air pressure NOTE Correct closing o...

Страница 35: ...an 1 1 mmol L the LO icon will appear on the display WARNING If the HI or LO message has appeared please consult your doctor or a healthcare professional before altering your treatment If the HI or LO...

Страница 36: ...y been used or the blood sample was applied before the drop icon started to blink on the display Remove the old test strip and repeat the test with a new one Wait until the drop icon starts to blink b...

Страница 37: ...bed during the countdown Repeat the test with a new test strip Low battery Change the batteries according to the instructions 7 3 The temperature was not within the recommended range Repeat the measur...

Страница 38: ...l control solution 4 3 c Change the test strip vial and repeat the measurement using a new test strip 4 2 d If you are still uncertain about the test results contact your doctor or healthcare professi...

Страница 39: ...easurement mmol L Test Range 1 1 33 3 mmol L Haematocrit range 10 70 haematocrit compensated Test strip GLUCOFIX TECH Sensor Test strip coding No coding required Sample Fresh capillary whole blood Sam...

Страница 40: ...from the NIST National Institute of Standards and Technology USA Temperature compensation Automatic compensation using a built in thermo sensor Batteries Two 3 0 V lithium batteries CR2032 Battery li...

Страница 41: ...r1 Temperature icon and Battery icon Dimensions 85 5 mm L x 56 mm W x 18 2 mm H Weight 46 g without batteries Meter Operating Conditions Temperature 5 45 C 41 113 F Relative Humidity 20 90 no dew cond...

Страница 42: ...eter complies with applicable electromagnetic emission requirements EMC Operading radio frequency band s 13 56 MHz Maximum radiofrequency power transmitted in the operating frequency band s 0 0042 mW...

Страница 43: ...limitations this warranty is only applicable to the original purchaser this warranty does not apply to units which malfunction or are damaged due to obvious tampering misuse alteration neglect unauth...

Страница 44: ...re limitation Use by Manufacturer Batch code In vitro diagnostic medical device In vitro device for self testing Serial number Recyclable package CE marking Contamination risk due to the use of blood...

Страница 45: ...GLUCOFIX TECH 51415 02 20 UK 45...

Страница 46: ...GLUCOFIX TECH 51415 02 20 UK 46...

Страница 47: ...GLUCOFIX TECH 51415 02 20 UK 47...

Страница 48: ...51415 02 20...

Страница 49: ...ANUAL UK 51415 02 20 150 x 102 CMYK PANTONE 877 C INDICAZIONI STAMPA USER MANUAL BOOKLET composto da 40 pagine interne stampate ad 1 colore k 100 in b v 4 pagine di coperta stampata a 5 colori in bian...

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