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GlucoCheck EVOLVE., Руководство пользователя

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REFERENT

REFERENT

In vitro

 diagnostic medical 

device

Consult instructions for use

Temperature limitation

Use by / Expiry date

Batch code

Serial number

Caution, consult 
accompanying documents

Manufacturer

CE mark

Humidity Limitation

Collection for electrical and

electronic equipment

Authorized representative 
in the European Community

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Содержание EVOLVE.

Страница 1: ...OWNER S MANUAL Blood glucose monitoring system GEMM ver 1 0 20170520 ...

Страница 2: ......

Страница 3: ...oring of your blood glucose levels can help you and your doctor gain better control of your diabetes Due to its compact size and easy operation you can use the GlucoCheck Evolve Blood Glucose Monitoring System to easily monitor your blood glucose levels If you have any additional questions regarding this product please contact the place of purchase or Homemed Pty Ltd customer service on 0861 106 1...

Страница 4: ...s thoroughly and practice the test Carry out all the quality control checks as directed 8 Keep the device and testing equipment away from young children Small items such as the battery cover batteries test strips lancets and vial caps are choking hazards 9 Use of this instrument in a dry environment especially if synthetic materials are present synthetic clothing carpets etc may cause damaging sta...

Страница 5: ...ting 11 Preparing the Puncture Site 11 Performing a Blood Glucose Test 12 Alternative Site Testing 15 METER MEMORY 16 Reviewing Test Results 16 Reviewing Blood Glucose Day Average Results 16 DOWNLOADING RESULTS ONTO A COMPUTER 18 MAINTENANCE 19 Batteries 19 Replacing the Batteries 19 Caring for Your Meter 20 Caring for Your Test Strips 20 Important Control Solution Information 21 SYSTEM TROUBLESHO...

Страница 6: ...t with your blood glucose test results and you have followed all the instructions given in this owner s manual contact your healthcare professional We do not recommend using this product on severely hypotensive individuals or patients in shock Please consult with your healthcare professional before use The measurement unit used for indicating the concentration of blood or plasma glucose is millimo...

Страница 7: ...test strip slot Test Strip Ejector Eject the used test strip by sliding the button upwards Main Button M Enter the meter memory and silence a reminder alarm Data Port Download test results with a cable connection Battery Compartment Uses 2x AAA batteries SET Button S Enter and confirm the meter settings 1 2 3 5 4 6 7 8 Meter Overview BACK FRONT SIDE ...

Страница 8: ... Symbol Day Average Test Strip Handle Contact Bars 10 11 12 13 14 1 2 3 4 15 16 Test Strip ATTENTION The front side of the test strip should face up when inserting the test strip into the meter Test results might be wrong if the contact bars are not fully inserted into the test strip slot NOTE The GlucoCheck EVOLVE meter should only be used with GlucoCheck Test Strips Using other test strips with ...

Страница 9: ...12h or 24h Press S 3 Setting the time With the HOUR MINUTE flashing in sequence press M until the correct hour minute appears Press S 4 Setting the low and high target range for measuring mode The sequence of the low and high target range setting is Gen low è Gen high è AC low è AC high è PC low è PC high With the settings mentioned above flashing in sequence press M until the desired target appea...

Страница 10: ...o the next alarm setting NOTICE At the alarm time the meter will beep and automatically switch on You can press M to silence the alarm If you do not wish to perform a test press and hold M to switch the meter off If you do not silence the alarm the meter will beep for 2 minutes then switch off Congratulations You have completed all settings NOTE These parameters can ONLY be changed in the setting ...

Страница 11: ...1 Start with the meter switched off Insert a test strip to switch the meter on The screen will display a flashing and Gen 2 Press M to switch between General AC PC and QC mode MODES General displays as Gen AC PC QC USE WHEN any time of day without regard to time since last meal before a meal 2 hours after a meal testing with the control solution ...

Страница 12: ...eter at least once a week to routinely check the meter and test strips you start using a new vial of test strips you suspect the meter or test strips are not working properly your blood glucose test results are not consistent with how you feel or if you think the results are not accurate practicing the testing procedure or you have dropped or think you may have damaged the meter Performing a Contr...

Страница 13: ... control solution Shake the control solution bottle thoroughly before use Squeeze out the first drop and wipe it off then squeeze out another drop and place it on the tip of the bottle cap Hold the meter to move the absorbent hole of the test strip to touch the drop Once the confirmation window fills completely the meter will start counting down NOTE To avoid contaminating the control solution do ...

Страница 14: ...rips may be faulty Please contact Homemed Pty Ltd customer service on 0861 106 150 for assistance NOTE The control solution range printed on the test strip vial is for control solution use only It is not a recommended range for your blood glucose level See the MAINTENANCE section for important information about your control solutions ...

Страница 15: ...fore obtaining a blood sample has a significant influence on the glucose value obtained Please follow the suggestions below before obtaining a drop of blood Wash and dry your hands before starting Select the puncture site either at fingertips or alternative puncture site please see section Alternative Site Testing AST on how to select the appropriate sites Rub the puncture site for about 20 second...

Страница 16: ...peated punctures at the same spot may cause soreness and calluses Please consult your healthcare professional before you perform AST It is recommended that you discard the first drop of blood as it might contain tissue fluid which may affect the test result Performing A Blood Glucose Test To perform a blood glucose test you will need 1 Meter 2 Test Strip 3 Lancing Device 1 Insert the test strip to...

Страница 17: ...confirmation window completely filled Do NOT remove your finger until you hear a beep sound NOTE Do not press the punctured site against the test strip or try to smear the blood If you do not apply a blood sample to the test strip within 2 minutes the meter will automatically switch off You will need to remove and reinsert the test strip to start a new test The confirmation window should be filled...

Страница 18: ...meter memory 7 Eject the used test strip Eject the test strip by sliding the eject button upwards The meter will switch off automatically WARNING Always follow the instructions in the lancing device insert when removing the lancet The used lancet and test strip may be biohazardous Please dispose of them carefully according to your local infection control procedures ...

Страница 19: ...ges faster than capillary blood at other sites Thus when testing blood glucose during or immediately after a meal physical exercise or any other event take a blood sample from your finger only We strongly recommend that you perform AST ONLY at the following times In a pre meal or fasting state more than 2 hours since the last meal Two hours or more after taking insulin Two hours or more after exer...

Страница 20: ... each time you press After the last test result press M again and the meter will be switched off Alternatively you can press and hold M for 5 seconds to switch off the meter Reviewing Blood Glucose Day Average Results 1 Press and release M When appears on the display keep M pressed in for 3 seconds until the flashing DAY AVG appears Release M your 7 day average result measured in general mode will...

Страница 21: ...ny action for 2 minutes The meter will switch off automatically Control solution results are NOT included in the day average When using the meter for the first time displays when you recall the test results or review the average result It is an indication that there is no test results in the memory ...

Страница 22: ...nnect the cable to an USB port on your computer With the meter switched off connect the other end of the RS232 cable to the meter data port PC will appear on the meter display indicating that the meter is in communication mode 2 Data transmission To transmit data follow the instructions provided with the software Results will be transmitted with date and time The meter will automatically switch of...

Страница 23: ...t remains accurate but it is time to change the batteries 2 The symbol appears with E b message The power is not enough to perform a test Please change the batteries immediately Replacing the Batteries To replace the batteries make sure the meter is switched off 1 Press the edge of the battery cover and lift it up 2 Remove the old batteries and replace with two new 1 5V AAA size alkaline batteries...

Страница 24: ... regulations Caring For Your Meter Cleaning To clean the meter exterior wipe it with a cloth moistened with tap water or a mild cleaning agent then dry the device with a soft dry cloth Do NOT rinse with water Do NOT use organic solvents to clean the meter Meter Storage Storage conditions 20 C to 60 C below 95 relative humidity Always store or transport the meter in its original storage case Avoid ...

Страница 25: ...ical assistance For further information please refer to the GlucoCheck test strip package insert Important Control Solution Information Use only GlucoCheck control solutions with your meter Do not use the control solution beyond the expiry date or 3 months after first opening Write the opening date on the control solution bottle and discard the remaining solution after 3 months It is recommended t...

Страница 26: ... 1 1 mmol L 1 1 3 9 mmol L or readings below the relevant personalised premeal target range 13 3 mmol L 33 3 mmol L 4 7 mmol L or relevant personalised premeal target range 7 1 13 2 mmol L or readings above the relevant personalised premeal target range 5 10 mmol L or the relevant personalised postmeal target range 10 1 13 2 mmol L or readings above the relevant personalised postmeal target range ...

Страница 27: ...en the meter and test strip are at the desired temperature Appears when ambient temperature is above system operation range Problem with the meter Repeat the test with a new test strip If the problem persists please contact the local customer service for assistance Appears when test strip is removed while counting down Review the instructions and repeat test with a new test strip If the problem pe...

Страница 28: ... Defective meter or test strips Please contact the local customer service 2 If the test does not start after applying the sample POSSIBLE CAUSE ACTION Defective test strip Repeat the test with a new test strip Sample applied after automatic switch off 2 minutes after last user action Repeat the test with a new test strip Apply sample only when flashing appears on the display Defective meter Please...

Страница 29: ...ke the control solution vigorously and repeat the test again Expired or contaminated control solution Check the expiry date of the control solution Control solution that is too warm or too cold Control solution meter and test strips should be at room temperature 20 C to 25 C before testing Defective test strip Repeat the test with a new test strip Meter malfunction Please contact the local custome...

Страница 30: ...professional to determine an appropriate target range for you Type 1 diabetic patients should consult with their healthcare team for appropriate blood glucose target values To set your individual high and low target ranges please consult the Setting the Meter section of this manual TIME OF DAY Fasting and before meal 2 hours after meals NORMAL PLASMA GLUCOSE RANGE 4 0 7 0 mmol L Majority of patien...

Страница 31: ...onsult instructions for use Temperature limitation Use by Expiry date Batch code Serial number Caution consult accompanying documents Manufacturer CE mark Humidity Limitation Collection for electrical and electronic equipment Authorized representative in the European Community SYMBOL ...

Страница 32: ...Auto switch off after 2 minutes without action Temperature Warning Operating Condition 10 C to 40 C below 85 R H non condensing Meter Storage Transportation Conditions 20 C to 60 C below 95 R H Strip Storage Transportation Conditions 4 C to 40 C below 85 R H Measurement Units mmol L Measurement Range 1 1 33 3 mmol L Expected Service Life 5 years This device has been tested to meet the electrical a...

Страница 33: ...warranty is valid only if the Warranty Certificate and Warranty Registration Card are duly completed with date of purchase serial number and dealer s stamp and if the Warranty Registration Card is sent to our office not later than 30 days from purchase 4 This warranty is void if this product has been repaired or serviced by an unauthorised person This warranty does not cover defects caused by misu...

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Страница 36: ...l 0861 106 150 Address 100 Sovereign Drive Route 21 Corporate Park Nellmapius Drive Irene 0157 South Africa TaiDoc Technology Corporation B1 7F No 127 Wugong 2nd Rd Wugu Dist 24888 New Taipei City Taiwan MedNet GmbH Borkstraβe 10 48163 Mϋnster Germany For self testing ...

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