Ypsomed mylife Unio Cara Скачать руководство пользователя страница 74

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Description of symbols used

Manufacturer

EU Representative

IVD

For in-vitro diagnostic use

For single use only

Use by

Storage temperature limitations

Sterilised using irradiation

Caution (consult instructions for use and warnings)

CE Mark

CE Mark with number of Notified Body

Consult instructions for use

Lot number

Reference number

Serial number

Separate collection of electrical and
electronic equipment

Biological risks

Global Trade Item number (international and unique identifier for trade items)

Содержание mylife Unio Cara

Страница 1: ...User guide Blood glucose monitoring system mg dL More freedom More confidence With mylife ...

Страница 2: ...at the blood glucose level should be monitored regularly The mylife Unio Cara blood glucose monitoring system is accurate and easy to use and is therefore your reliable diabetes management assistant The mylife AutoLance lancing device and mylife Lancets are intended for patient self monitoring by an individual They must not be used on more than one person due to the risk of cross contamination The...

Страница 3: ...8 set blood glucose target range 30 volume on off 32 Records recall test results 33 Averages recall average test results 34 Quality control test 37 Data management 44 Battery change 46 mylife AutoLance lancing device Overview 48 Handling 49 Alternative site testing AST 51 mylife Unio test strips 54 Further information Precautions 57 Limitations of the mylife Unio Cara meter 59 Maintenance cleaning...

Страница 4: ...omer support staff are available to assist you Healthcare professionals may use the mylife Unio Cara blood glucose monitoring system for surveillance of the blood glucose levels of patients in medical facilities For a better understanding of this user guide the mylife Unio Cara blood glucose monitoring system will be referred to as BGMS the mylife Unio Cara blood glucose meter as meter the mylife ...

Страница 5: ...fe Unio Cara blood glucose meter with 2 CR2032 3 volt batteries installed Vial with mylife Unio test strips 10 pcs mylife AutoLance lancing device Disposable mylife Lancets 10 pcs mylife Unio Cara user guide mylife Unio Cara quick start guide Diabetes diary ...

Страница 6: ... results to compatible wireless devices such as PCs and smartphones The mylife Unio Cara meter is designed to work with the mylife App Visit www mylife diabetescare com software for information on which wireless devices are compatible with your mylife Unio Cara meter and where how to download the mylife App and mylife Software on your compatible device Bluetooth wireless technology ...

Страница 7: ...er transmits test results to your compatible wireless device To prevent other people s results from being sent to your compatible wireless device do not let anyone else use your meter to test their blood glucose This meter is for single patient use only WARNING In locations where cell phone use is not permitted such as hospitals some healthcare professionals offices and airplanes you should turn t...

Страница 8: ...Display Shows test results messages and all other relevant information Up and down scroll buttons For operating the meter please consult the details in the following sections Main confirm button Single click confirm 0 5 second click power on 1 second click return to home screen 3 second click power off ...

Страница 9: ...r instructions see page 46 Bar code with relevant product and production information Micro USB port For data transfer by a cable to a PC Mac data management Unlock button By pressing with e g a pen tip 2 CR2032 batteries ...

Страница 10: ...10 Display and symbol overview ...

Страница 11: ...e memory Appears after test strip insertion into the meter Indicates the time format is 12H Indicates a control solution test result Warns when the operational temperature limit is exceeded during testing Test result Current date under time mode or testing date under memory mode Displays current time under time mode or testing time under memory mode Warns when the battery is low or must be replace...

Страница 12: ... second to set the alarms To turn on the meter press the main button for 0 5 seconds or insert a test strip To turn off the meter manually press and hold the main button for 3 seconds To turn off the meter automatically the meter will power off automatically after 30 seconds if no buttons are pressed or no strip is inserted To navigate in the menu of the meter use the following buttons To scroll d...

Страница 13: ...ble cap by turning both parts smoothly in opposite direc tions Twist off and set aside the protective cap of the disposable lancet Insert a new disposable lancet firmly into the lancet carrier Close the depth adjustable cap by smoothly turning both parts into lock position ...

Страница 14: ...ing the cap 1 3 for soft or thin skin 4 5 for average skin 6 7 for thick or calloused skin Take one test strip from the vial and close the cap of the vial immediately Insert the test strip into the test strip port on the meter The meter will automatically activate ...

Страница 15: ...nal if volume is turned on Recommended sites for obtaining blood 1 Press the security button to unlock the lancing device keep pressing until finger is pricked 2 Place the finger against the lancing device and press the finger on the cap The lancing device has an automatic load and release function no priming nec essary ...

Страница 16: ...of the meter is switched on and the measurement process starts If the view window of the test strip is not completely filled with blood the measurement will not be performed Discard the test strip and repeat the test with a new one The countdown mode will begin on the display window After 5 seconds the test result will appear To upload data onto the mobile device please refer to pages 20 24 and 26...

Страница 17: ...range The upper limit bar blinks twice if your measurement is above the defined target range The lower limit bar blinks twice when your measurement is below the defined target range For further information about your test result please consult your healthcare professional If your test result is below 10 mg dL Lo will appear on the screen If your test result is above 600 mg dL Hi will appear on the...

Страница 18: ... measurement the pre prandial symbol will flash on the screen You can set up to four markers per measurement Select the markers by using the down or up button To confirm a marker press the main button short press if you do not want confirm a marker use the down or up button In both cases the next marker will blink If you don t want to set any marker or leave the marker setting press the main butto...

Страница 19: ...s in the lower left corner You can select the different setting functions by using the down or up button When selecting a setting function confirm it with the main button You are then able to change the respective setting The setting process of the selected setting function is completed after going through the setting flow To confirm a setting function press the main button short press If you wish...

Страница 20: ...Before you can turn on off flight mode you first need to configure Bluetooth by paring at least one device please refer to page 24 When the meter is configured with a mobile device the Bluetooth symbol is shown statically on the display Bluetooth is in sleep mode After a measurement Bluetooth activates automatically If Bluetooth is in sleep mode and you are not performing a measurement but want to...

Страница 21: ...for 2 seconds Press the main button to confirm F1 Bluetooth flight mode can be switched on or off Scroll down or up to select on or off and confirm the settings with the main button blt off flight mode on blt on flight mode off For more information about how to work with Bluetooth please refer to pages 24 and 26 ...

Страница 22: ...by pressing the main button This feature reminds the user when to perform a test There are 4 sets of alarms available When an alarm is turned on the meter will beep for 30 seconds To turn off the alarm insert a test strip or press any button To set a daily alarm you can press the down and main buttons simultaneously for 1 second and you enter directly into the alarm mode please see next page ...

Страница 23: ...n Set the hour by pressing the down or up button Confirm by pressing the main button Set the minutes by pressing the down or up button Confirm by pressing the main button You can set 4 alarms from AL 1 to AL 4 Choose the number by pressing the down or up buttons Confirm by pressing the main button ...

Страница 24: ...ndicating that the procedure for pairing will be performed now Make sure that Bluetooth is turned on on your mobile device and that the app is activated The mylife Unio Cara is equipped with Bluetooth technology for wireless data transmission between the meter and a mobile device Bluetooth is turned off deactivated by default If you wish to use this wireless connectivity you first need to establis...

Страница 25: ... Repeat the procedure After having entered the code into the mylife App the meter and mobile device are paired successfully by indicating the device no d1 d2 or d3 Subsequently the home screen incl Bluetooth symbol will be shown Up to 3 mobile devices can be paired with mylife Unio Cara A device identifier d1 d2 and d3 is provided by the meter Note the name of your mobile device to every identifie...

Страница 26: ...hich data can be polled by the app The Bluetooth symbol is flashing during that time If Bluetooth is in sleep mode and you are not performing a measurement but want to synchronise data with the app you can activate Bluetooth on the home screen by pressing the main and up buttons simultaneously for 2 seconds Bluetooth is configured sleep mode requires min 1 paired device à The Bluetooth symbol is s...

Страница 27: ...mode Press the down or up button until you see F4 Confirm with the main button In the lower right corner d1 blinks to prompt to select the device to be removed Use the down or up button to select between all paired devices After having selected the appro priate device d1 d2 or d3 to be removed confirm the removal with the main button ...

Страница 28: ...ee the current month Confirm by pressing the main button Once the month is confirmed the day setting will appear Press the down or up button until you see the current day Confirm by pressing the main button You can enter the date time setting mode by pressing the down and up buttons simultaneously for 2 seconds Scroll with the down or up button until you see F5 Confirm by pressing the main button ...

Страница 29: ...24H Confirm by pressing the main button Once the time format is con firmed the hour setting will appear Press the down or up button until you see the current hour Confirm by pressing the main button Once the hour is confirmed the minute setting will appear Press the down or up button until you see the current minute Confirm by pressing the main button ...

Страница 30: ...sing the down and up buttons simultaneously for 2 seconds Scroll with the down or up button until you see F6 Confirm by pressing the main button The target range function can be switched on or off standard setting is off Scroll down or up to select on or off and confirm the settings with the main button ...

Страница 31: ...utton to adjust the value Press the main button to confirm The adjustable target range for the lower and up per limit is the same for both and lies between 60 mg dL and 300 mg dL The lower limit cannot be higher than the upper limit and vice versa Both limits cannot have the same value Please discuss the blood glucose target range with your physician When turning the blood glucose target range on ...

Страница 32: ...e volume on or off Confirm by pressing the main button Settings volume on off You can enter the volume setting mode by pressing the down and up buttons simultane ously for 2 seconds Scroll with the down or up button until you see F7 Confirm by pressing the main button ...

Страница 33: ...ords power on the meter without inserting a test strip by pressing the main button Press any button to switch from the home screen to the memory mode The memory symbol in the upper left corner will be dis played The latest test result will appear with the number 1 in the lower right corner Use the down and up button to review all previous results with date and time and marker Results are displayed...

Страница 34: ...days 30 days 60 days and 90 days The average will not be calculated with the results from the control solution test To recall your average test results power on the meter without inserting a test strip by pressing the main button Press again 2 times the main button On the top line the average symbol is displayed Averages recall average test results ...

Страница 35: ... large number with the mg dL specification indicates the calculated average of the measurements during the selected period which is shown on the bottom line on the left The number shown in the lower right corner indicates how many test results have been considered for the calculation ...

Страница 36: ...orrectly on your meter to enable correct average calculations The quantity of the measurements within the chosen days must be 0 For example the 14 day average will show no figure if no measurements have been performed during this time The Lo and Hi results control solution test results and test results under abnormal temperature 6 C or 44 C will be excluded from average calculations ...

Страница 37: ...ctise and check the correct the testing procedure Only use a control solution tested with the BGMS under control solution mode If the test result is within the control solution range printed on the label of the test strip vial the BGMS passes the quality control test That means your BGMS is working correctly There are two different types of control solutions available normal and high Control solut...

Страница 38: ...trol solution write the date of opening on the label The control solution is usable for up to 3 months after opening the bottle or until the expiry date printed on the label whichever comes first Control solution test results do not represent your blood glucose level ...

Страница 39: ...est strip into the test strip port A flashing control solution symbol with the test strip symbol appear Enter the control measurement by pressing the down and up buttons simultaneously for 2 seconds Scroll with the down or up buttons until you see F8 Confirm by pressing the main button ...

Страница 40: ...the table Drip a drop of control solution on the top of the cap Gently place the sample entry of the test strip onto the drop of control solution on the top of the cap As soon as the control solution symbol with the test strip symbol are stable a flashing blood drop prompts to apply the corresponding con trol solution ...

Страница 41: ...of the control solution test appears The result will automatically be marked with the control solution marker Compare your quality control test result to the control solution range printed on the test strip vial label This result will not be used for the average calculations of your meter Clean the top of the cap and close the cap on the control solution bottle ...

Страница 42: ...nge Your control solution has expired or has been opened more than 3 months ago Your test strips have expired or have been opened more than 12 months ago Your control solution is diluted The cap of the test strip vial or the control solution has been left open for a long time The test procedure was not performed correctly Malfunction of the meter or the test strip Your control solution test has be...

Страница 43: ...trol solution test is 6 44 C Do not drip the control solution directly from the bottle onto the sample entry of the test strip The reagent on the test strip could be sucked into the bottle of control solution and could cause the solution to degenerate Doing so could potentially contaminate the meter via the test strip port Do not touch the nozzle of the control solution bottle If you have touched ...

Страница 44: ...ylife Unio Cara to the mylife Software can also be carried out by using the Bluetooth interface of the meter in combination with a specific dongle for the PC To do this the mylife Unio Cara initially needs to be paired with the PC Please follow the instructions for pairing the meter and PC software as described in the section Settings pairing deleting a device on page 24 A micro USB data cable or ...

Страница 45: ...de sign for ease of use trend reports and useful statistics for a better therapy overview The mylife Software is compatible with all mylife Diabetescare devices such as mylife Unio mylife Unio Neva mylife Unio Cara mylife Pura mylife Pura X and mylife YpsoPump and a wide range of other devices for a complete therapy picture Get more information about the mylife Software at www mylife diabetescare ...

Страница 46: ... tests under normal circumstances To insert the batteries proceed as follows To insert change the batteries of your meter use a pen point to press the bottom right spot on the cover at the same time slide up the cover Remove the old batteries and insert the new ones Be sure to insert the batteries in the correct direction polarity facing up ...

Страница 47: ...es all symbols will appear on the screen Press any button to exit the self test and enter into the setting mode You must set the time and date when replacing the batteries Please refer to page 28 Date and time need to be set again after each battery replace ment Measure ments target range volume and pairing information will not be deleted when changing batteries ...

Страница 48: ...ss the cap on the desired penetration site Depth adjustable cap Open the cover to replace the lancet Penetration depth window Choose the penetration depth by turning the cap Mechanics holder To insert the disposable lancet Safety button To prevent accidental release ...

Страница 49: ...oLance Take off the depth adjustable cap by turning both parts smoothly in opposite directions Twist off and set aside the protective cover of the disposable lancet Insert a new disposable lancet firmly into the lancet carrier ...

Страница 50: ... press your finger smoothly on the cap The lancing device loads and releases automatically No priming necessary Place the finger against the lancing device and press the safety button Choose the penetration depth by turning the cap 1 3 for soft or thin skin 4 5 for average skin 6 7 for thick or calloused skin ...

Страница 51: ...t on an alternative site The AST cap can be ordered at your local Ypsomed customer service see page 72 The AST function can enable you to test the blood glucose level on sites other than the fingertips and helps you to avoid repeatetly pricking the fingertips and thus reducing pain ...

Страница 52: ... and immediately after massaging the puncture area press and release the lancing device with the clear cap against it Continue holding the lancing device against the puncture site and gradually increase pressure for a few seconds until the blood sample size is sufficient ...

Страница 53: ...e fingertip should be used DO NOT test on the palm or forearm if you are testing for hypoglycaemia low blood glucose or hypoglycaemia perceptional disorder Fingertip samples can show rapid changes of glucose faster than palm or forearm samples As the blood flow taken from the forearm or palm is slower than from the fingertip we recommend using the lancing device with clear cap AST cap for testing ...

Страница 54: ...applying blood sample It gradually turns red as it fills with blood Indication symbol Insert test strip with indication symbol up front and down towards meter Handle bar Grip here to insert test strip into meter Electrode contacts Sensing signal output terminals mylife Unio test strips The meter must only be used with mylife Unio test strips The use of other test strips may lead to incorrect test ...

Страница 55: ...s Record the date of opening a new test strip vial for the first time Discard the vial of test strips 12 months after the first opening Store the test strips in a cool 4 30 C and dry location 90 relative humidity Do not expose to heat or direct sunlight If the meter and test strips are exposed to considerable temperature variation please wait 30 minutes before measurement ...

Страница 56: ...ew test strip Check the expiry date printed on the test strip vial every time you use a test strip Do not use expired test strips Use each test strip immediately after removing it from the vial Fill the blood drop only to the sample entry of the test strip Please do not drip or inject the blood sample directly onto the sample entry of the test strip using a syringe Doing so may contaminate the met...

Страница 57: ...incorrect results If the meters and test strips are exposed to considerable temperature variation please wait 30 minutes before performing the measurement Dispose of used batteries properly in compliance with local regulations Please note that the BGMS contains small parts e g test strips which are a potential choking hazard for children Do not allow water to enter the meter Never immerse the mete...

Страница 58: ...ample size above 3 0 µL might contaminate the test strip port and the meter Make sure your blood sample covers the whole area of the view window to get an accurate test result A sample size below 0 7 µL may lead to an error message see page 65 If this occurs repeat the test with a new test strip 0 7 µL 1 5 µL 2 0 µL 3 0 µL 4 0 µL ...

Страница 59: ... dL If the mylife Unio Cara meter and mylife Unio test strips are exposed to considerable variation in temperature please wait 30 minutes before measurement Do not test the blood sample from palm or forearm when glucose is changing rapidly scenarios after drinking after meal after exercise Do not test on the palm or forearm if you are testing for insulin dose calculations or hypogly caemia low blo...

Страница 60: ...n If any dust or impurities appear please clean with a small soft brush otherwise the meter may not work correctly when you insert a test strip Users should wash their hands thoroughly with soap and water after handling the meter lancing device or test strips Please examine your LCD screen test strip port buttons and surface of your meter and lancing device after cleaning and disinfecting Stop usi...

Страница 61: ...infecting wipes to remove any possible dirt dust blood and other body fluids To disinfect the meter 1 Take another disinfecting wipe and wipe the meter thoroughly note all blood and body fluids should be cleaned from surface before disinfection 2 Allow the surface to remain wet for 1 minute 3 Allow to air dry ...

Страница 62: ... disinfecting wipes to remove any possible dirt dust blood and other body fluids To disinfect the lancing device 1 Take another disinfecting wipe and wipe the lancing device thoroughly note all blood and body fluids should be cleaned from surface before disinfection 2 Allow the surface to remain wet for 1 minute 3 Allow to air dry ...

Страница 63: ...ange the batteries immediately see page 46 Error 2 Sampling Do not apply the blood to the sample port of the test strip before the sample symbol is displayed Please discard the test strip if the meter shows the Er2 symbol and repeat the test with a new test strip Error 0 Strip damage The inserted test strip has been used or damaged Please use a new test strip ...

Страница 64: ...he unused test strip correctly If after performing the required steps the strip symbol and flashing Er3 symbol appear on the screen the test strip has been inserted incorrectly more than twice Please reinsert the unused test strip again after reviewing the steps on how to insert a test strip correctly on page 13 or call your local Ypsomed customer service for support see page 72 This error message...

Страница 65: ...ibration A calibrating error occurred Please follow the steps below 1 Remove the test strip from the meter 2 Turn off the meter press and hold the main button for 3 seconds 3 Press the main button to turn on the meter If Er7 is not shown after turning on the meter your meter is func tioning properly and is able to perform a test If the meter still does not work please contact your local Ypsomed cu...

Страница 66: ...devices A maximum of 3 mobile devices have already been paired to the meter To add a new device delete one first Confirm the warning with the main button see page 24 Error 8 Bluetooth Timeout during paring procedure 1 No connection Make sure a the app is installed started and in pairing mode b Bluetooth is enabled and c the mobile device is close enough max 10 m 2 Passcode not entered in time repe...

Страница 67: ...ip after the test strip has been inserted correctly and the meter s screen is showing the image of the test strip and a flashing blood drop symbol If the flashing blood drop symbol is not showing on the screen do not apply a sample to the test strip Please reinsert the unused test strip correctly The screen must show the image of the test strip accompanied by the flashing blood drop symbol this sy...

Страница 68: ...llary venous and arterial whole blood Minimum sample volume 0 7 μL Coding Autocoding no user interaction required Measuring range 10 600 mg dL Test time 5 seconds Memory capacity 1000 measurements Power saving On Operating temperature 6 44 C Operating relative humidity 10 90 Haematocrit 20 70 when blood glucose 200 mg dL 20 60 when blood glucose 200 mg dL ...

Страница 69: ...ata interface Option A wireless via Bluetooth transmission range 10 m Option B micro USB port micro USB USB A type cable Data management Data can be transferred to the mylife App and to a PC based software such as the mylife Software SiDiary Diabass and diasend conformity to be reconfirmed Please contact your local customer service see page 72 Disclaimer The third party trademarks used herein are ...

Страница 70: ...arry a risk of contamination Please dispose of your used meter after removing the batteries in compliance with local regulations For information about correct disposal please contact your local authority Used test strips and lancets are potentially infected Please dispose of the used test strip and or the puncture proof or biohazard container for your used lancets in compliance with local regulati...

Страница 71: ...urchase This warranty does not apply to the performance of a mylife Unio Cara blood glucose monitoring system that has been altered misused tampered with or abused in any way This warranty applies only to the original purchaser of the mylife Unio Cara meter This warranty does not apply for any damage caused by the use of other test strips than mylife Unio test strips Warranty ...

Страница 72: ...SPRL Allée de la Recherche 12 BE 1070 Bruxelles Klantenservice Service clientèle 0800 294 15 info ypsomed be www mylife diabetescare be CH Ypsomed AG Brunnmattstrasse 6 CH 3401 Burgdorf Kostenlose Service Hotline numéro gratuit numero verde 0800 44 11 44 info ypsomed ch www mylife diabetescare ch DE Ypsomed GmbH Höchster Straße 70 DE 65835 Liederbach Kostenlose Service Hotline 0800 9776633 info yp...

Страница 73: ...7 info ypsomed co in www mylife diabetescare co in NL Ypsomed BV Postbus 1190 NL 3430 BD Nieuwegein Klantenservice 0800 9776633 info ypsomed nl www mylife diabetescare nl NO Ypsomed AS Papirbredden Grønland 58 NO 3045 Drammen Tel 47 22 20 93 00 info ypsomed no www mylife diabetescare no SE Ypsomed AB Adolfsbergsvägen 31 SE 168 67 Bromma Kundtjänst 08 601 25 50 info ypsomed se www mylife diabetesca...

Страница 74: ...ons Sterilised using irradiation Caution consult instructions for use and warnings CE Mark CE Mark with number of Notified Body Consult instructions for use Lot number Reference number Serial number Separate collection of electrical and electronic equipment Biological risks Global Trade Item number international and unique identifier for trade items ...

Страница 75: ...ncing device Manufacturer Bionime Corporation No 100 Sec 2 Daqing St South Dist Taichung City 40242 Taiwan The product complies with Medical Device Directive 93 42 EEC CE EU Representative Bionime GmbH Tramstrasse 16 9442 Berneck Switzerland Disposable mylife Lancets Manufacturer SteriLance Medical Suzhou Inc No 68 Litanghe Road Xiangcheng Suzhou 215133 China The product complies with Medical Devi...

Страница 76: ...ung City Taiwan Bionime GmbH Tramstrasse 16 9442 Berneck Switzerland info bionime ch Manufactured for Ypsomed Distribution AG 3401 Burgdorf Switzerland www mylife diabetescare com 0197 Ypsomed Distribution AG Brunnmattstrasse 6 3401 Burgdorf Switzerland info ypsomed com www mylife diabetescare com 41 34 424 41 11 ...

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