Related Manuals for Ypsomed mylife Unio Cara
Summary of Contents for Ypsomed mylife Unio Cara
- Page 1 User guide Blood glucose monitoring system mg/dL More freedom. More confidence. With mylife ™...
- Page 2 They must not be used on more than one person due to the risk of cross-contamination. The mylife Unio Cara blood glucose monitoring system is manufactured by Bionime Corporation and distributed ™ ™ by Ypsomed Distribution AG. If you have any questions or concerns, please contact your local Ypsomed customer service (see page 72).
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Page 3: Table Of Contents
Table of contents First steps mylife AutoLance lancing device ™ ™ Intended use Overview mylife Unio Cara package contents Handling ™ ™ Bluetooth wireless technology Alternative site testing (AST) ® mylife Unio Cara blood glucose meter ™ ™ mylife Unio test strips ™... -
Page 4: Intended Use
Intended use The mylife Unio Cara blood glucose monitoring system is intended for in-vitro (outside the body) diagnostic use ™ ™ for self-testing. The coding of the test strips is automatically detected. The test result is plasma equivalent and achieved by using (a) fresh capillary whole blood that may be drawn from the fingertip, palm or forearm, (b) venous whole blood samples and (c) arterial whole blood samples. -
Page 5: Mylife Unio Cara Package Contents
mylife Unio Cara package contents ™ ™ ➊ mylife SoftCase ™ ➋ mylife Unio Cara blood glucose meter ™ ™ (with 2 CR2032, 3 volt batteries installed) ➌ Vial with mylife Unio test strips (10 pcs.) ™ ™ ➍ mylife AutoLance lancing device ™... -
Page 6: Bluetooth ® Wireless Technology
Bluetooth wireless technology ® Bluetooth wireless technology is used by most smartphones and many other devices. Your mylife Unio ® ™ ™ Cara meter uses Bluetooth wireless technology to pair and to transmit your glucose results to compatible ® wireless devices (such as PCs and smartphones). The mylife Unio Cara meter is designed to work with the mylife... - Page 7 ® The Bluetooth word mark and logos are owned by Bluetooth SIG, Inc. and any use of ® ® such marks by Ypsomed Distribution AG is under license. Other trademarks and trade names are those of their respective owners.
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Page 8: Mylife ™ Unio ™ Cara Blood Glucose Meter
mylife Unio Cara blood glucose meter ™ ™ Test strip port Insert test strips here until you hear a click. Display Shows test results, messages and all other relevant information. Main/confirm button Single click: confirm. 0.5-second click: power on. Up and down 1-second click: return to home screen. - Page 9 Bar code with relevant product and production information 2 × CR2032 Battery cover batteries For instructions see page 46. Unlock-button Micro-USB port By pressing with For data transfer by a cable to a e.g. a pen tip. PC/Mac (data management).
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Page 10: Display And Symbol Overview
Display and symbol overview... - Page 11 ® Indicates that Bluetooth is configured Unit of the test result and not in flight mode Indicates the pre-meal marker Indicates the post-meal marker Indicates the exercise marker Indicates the fasting marker Indicates the illness marker Indicates when to apply the blood sample Indicates the average testing result Indicates the test result stored in the memory Appears after test strip insertion into the meter...
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Page 12: Menu Guidance
Menu guidance To turn on the meter: press the main On the backside of the mylife Unio Cara meter ™ ™ button for 0.5 seconds or insert a test the following short cuts are shown: strip. 2 sec à F1– F8 Press the down To turn off the meter manually: buttons simultaneously press and hold the main... -
Page 13: How To Perform A Blood Glucose Measurement
How to perform a blood glucose measurement Take off the depth-adjustable Insert a new disposable Twist off and set aside Close the depth-adjustable cap by turning both parts lancet firmly into the lancet the protective cap cap by smoothly turning smoothly in opposite direc- carrier. - Page 14 Choose the penetration depth Wash and dry your hands. Take one test strip from the Insert the test strip into the by turning the cap. 1 – 3 for soft vial and close the cap test strip port on the meter. or thin skin;...
- Page 15 Once the strip is inserted, the 1 Press the security button to Recommended sites for meter turns on, all symbols will unlock the lancing device obtaining blood. appear on the meter display (keep pressing until finger is accompanied by a beep signal pricked).
- Page 16 Gently squeeze your fingertip to get a drop of blood. Apply the blood drop to the edge of the test strip. When the viewing window is completely filled with blood, you will hear a beep (if the volume 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.
- Page 17 Beside the blood glucose result, The upper limit bar blinks twice If your test result is below 10 mg/dL, “Lo” will appear on the screen. you will also get an indication if your measurement is above If your test result is above 600 mg/dL, “Hi” will appear on the if your measurement is within, the defined target range.
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Page 18: Markers
Markers Markers have to be set after measurement within 10 seconds. They cannot be edited after confirma- tion. For every measurement, up to four markers can be set. Before meal/pre-prandial. Set this marker before you eat. After meal. Set this marker after you have eaten. After performing a measurement, the pre-prandial symbol will flash on the screen. -
Page 19: Settings: How To Access The Setting Function Mode
Settings: how to access the setting function mode You can enter the setting function mode (F1 – F8) by pressing the down and up buttons for 2 seconds. There are 8 possible setting modes: F1 à Flight mode on/off F2 à Alarm F3 à... -
Page 20: Bluetooth ® Flight Mode On/Off
Settings: Bluetooth flight mode on/off ® 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 ®... - Page 21 For more information about how to work with Bluetooth , please ® refer to pages 24 and 26. To set the Bluetooth flight Bluetooth flight mode can be switched on or off. Scroll ® ® mode via the setting function down or up to select on or off and confirm the settings...
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Page 22: Set An Alarm
Settings: set an alarm 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. - Page 23 You can set 4 alarms from “AL 1” Turn “on” or “off” the alarm Set the hour by pressing Set the minutes by pressing to “AL 4”. Choose the number by pressing the down the down or up the down or up by pressing the down or up...
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Page 24: Pairing/Deleting A Device
Settings: pairing/deleting a device 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 establish a connection between the meter and a mobile device by going through the following pairing procedure:... - Page 25 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 identifier d1 – d3 for example in the quick start guide in order to allocate each pairing to the corresponding mobile device.
- Page 26 ® Bluetooth is configured (= sleep mode), requires min. 1 paired device ® à The Bluetooth symbol is statically visible on the home screen ® Bluetooth is activated and the meter is ready to connect with a mobile device ® à...
- Page 27 To delete a device from your In the lower right corner “d1” After having selected the appro- meter press the down blinks to prompt to select priate device (d1, d2 or d3) to buttons simultaneously the device to be removed. Use be removed, confirm the removal for 2 seconds.
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Page 28: Set Date And Time
Settings: set date and time You can enter the date/time With the year format blinking, Once the year is confirmed, the Once the month is confirmed, press the down or up month setting will appear. Press the day setting will appear. setting mode by pressing the down and up... - Page 29 Once the day is confirmed, the time format selection will appear. Once the time format is con- Once the hour is confirmed, With the time format blinking, press the down or up button firmed, the hour setting will the minute setting will appear. to switch between 12H and 24H.
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Page 30: Set Blood Glucose Target Range
Settings: set blood glucose target range You can enter the blood glucose The target range function can be switched on or off (standard target range setting by pressing setting is off). Scroll down or up to select on or off and the down and up buttons... - Page 31 When turning the blood glucose target range on, The adjustable please define the target target range for range limits as following: 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 The upper limit bar will appear...
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Page 32: Volume On/Off
Settings: volume on/off You can enter the volume setting With the volume blinking, press the down or up button to turn mode by pressing the down the volume on or off. Confirm by pressing the main button. and up buttons simultane- ously for 2 seconds. -
Page 33: Records: Recall Test Results
Records: recall test results The meter stores 1 000 test results with time, date, marker and target range automatically. If your meter has stored 1 000 results, which is the maximum memory capacity, the oldest one will be deleted and the newest result will be stored. -
Page 34: Averages: Recall Average Test Results
Averages: recall average test results The meter is able to calculate averages. To recall the average of the measured test results, you have the option to choose between 1 day, 7 days, 14 days, 30 days, 60 days and 90 days. The average will not be calculated with the results from the control solution test. - Page 35 To navigate from one average The large number with the mg/dL specification indicates the calculated average of the measurements result to the other, use the during the selected period (which is shown on the bottom line on the left). The number shown down and up buttons.
- Page 36 The average function is related to the time setting. Time and date must be set correctly 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.
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Page 37: Quality Control Test
Quality control test with mylife ControlGDH control solution ™ A quality control test should be performed whenever you want to Control check if your BGMS is working properly or whenever you want to solution range mg/dL mmol/L practise and check the correct the testing procedure. Normal 83 –... - Page 38 Each time you open a new bottle of control 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.
- Page 39 Enter the control measurement A flashing control solution Take one test strip from Insert the test strip into the test by pressing the down symbol with the test strip the test strip vial and recap it strip port. buttons simultaneously for symbol appear.
- Page 40 As soon as the control solution Before opening the cap of the control solution, shake the bottle well. Open the bottle and place the symbol with the test cap upright on the table. Drip a drop of control solution on the top of the cap. Gently place the sample strip symbol are stable, a entry of the test strip onto the drop of control solution on the top of the cap.
- Page 41 When you hear a beep (if volume After five seconds, the test result of the control Clean the top of the cap and is switched on) please wait for solution test appears. The result will automatically close the cap on the control the test result.
- Page 42 BGMS. 12 months ago. Your control solution is diluted. Contact your local Ypsomed customer The cap of the test strip vial or the control solution has been left service (see page 72).
- Page 43 Your control solution test results will not be included in the average calculations, but can still be recalled. The control solution test result will be marked with the “CS” symbol on the screen. The suggested temperature range for the control solution test is 6 – 44 °C. Do not drip the control solution directly from the bottle onto the sample entry of the test strip.
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Page 44: Data Management
Cara meter lets you transfer data from the meter to a dongle for your PC can be ordered at compatible PC-based software, such as the mylife your local Ypsomed customer service ™ Software, by means of a conventional micro-USB cable. - Page 45 The mylife Software is a therapy management solution as mylife Unio , mylife Unio Neva, mylife Unio ™ ™ ™ ™ ™ ™ ™ designed to cover the needs of people with diabetes Cara, mylife Pura , mylife Pura X and mylife ™...
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Page 46: Battery Change
Battery change Your meter is delivered with 2 CR2032, 3 volt batteries installed. Two new batteries will provide power to perform about 1 000 tests under normal circumstances. To insert the batteries, proceed as follows: To insert/change the batteries of your meter, use a pen point to Remove the old batteries and press the bottom-right spot on the cover, at the same time slide up insert the new ones. - Page 47 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 Slide the battery cover back The mylife Unio Cara meter will enter into the self-testing mode ™...
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Page 48: Overview
mylife AutoLance overview ™ ™ Load and release function Simply press the cap on the desired penetration site. Penetration depth window Choose the penetration depth by turning the cap. Depth-adjustable cap Open the cover to replace the lancet. Safety button Mechanics holder To prevent To insert the disposable... -
Page 49: Handling
Handling of mylife AutoLance ™ ™ Take off the depth-adjustable Insert a new disposable lancet Twist off and set aside cap by turning both parts firmly into the lancet carrier. the protective cover of the smoothly in opposite directions. disposable lancet. - Page 50 Close the depth-adjustable Choose the penetration depth Place the finger against the While pressing the safety button, cap by smoothly turning it by turning the cap. 1 – 3 for soft lancing device and press the press your finger smoothly into lock position.
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Page 51: Alternative Site Testing (Ast)
Select the clear AST cap to perform a measurement on an alternative site. The AST cap can be ordered at your local Ypsomed customer service (see page 72). - Page 52 Massage the puncture area of the palm or forearm for a few Continue holding the lancing device against seconds and immediately after massaging the puncture area, press the puncture site, and gradually increase and release the lancing device with the clear cap against it. pressure for a few seconds until the blood sample size is sufficient.
- Page 53 The blood glucose test results of blood samples taken from different sites may vary in certain conditions; rapid changes in glucose levels following a drink or a meal, an insulin dose or exercise may be seen. In these cases, only the fingertip should be used.
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Page 54: Mylife ™ Unio ™ Test Strips
mylife Unio test strips ™ ™ The meter must only be used with mylife ➊ Sample entry ™ Unio test strips. The use of other test Apply a drop of blood or control solution here. The ™ strips may lead to incorrect test results. test requires only 0.7 µL of blood. - Page 55 Close the test strip vial immediately after taking out the test strip. Do not reuse test strips. Test strips are intended to be used only once. Do not use expired test strips. 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.
- Page 56 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.
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Page 57: Precautions
Precautions Before using the BGMS to test your blood glucose, please read the user guide carefully. The meter must only be used with mylife Unio test strips and mylife ControlGDH control ™ ™ ™ solution. The use of other strips or control solutions may lead to incorrect results. If the meters and test strips are exposed to considerable temperature variation, please wait 30 minutes before performing the measurement. - Page 58 The minimum blood sample size for testing is 0.7 µL. 0.7 µL 1.5 µL 2.0 µL 3.0 µL 4.0 µL Please use a minimum of 0.7 µL to perform the test with the BGMS. A blood sample 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.
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Page 59: Limitations Of The Mylife ™ Unio ™ Cara Meter
Limitations of the mylife Unio Cara meter ™ ™ For capillary, venous and arterial whole blood testing only. The BGMS is not intended for serum or plasma testing. Inaccurate test results may be obtained at an altitude of more than 3 048 meters (10 000 feet). Severe dehydration may cause inaccurately low results. -
Page 60: Maintenance, Cleaning And Disinfection
Maintenance, cleaning and disinfection Keep your meter and test strip free of dust, water or any other liquid. If the meter is dropped or damaged, perform a quality control test (see page 37) before performing a blood glucose test to ensure that the meter is still functioning correctly. - Page 61 Clean and disinfect the meter To clean the meter thoroughly To disinfect the meter: wipe the entire surface of the 1. Take another disinfecting wipe and wipe the meter thoroughly meter with disinfecting wipes to (note: all blood and body fluids should be cleaned from surface remove any possible dirt, dust, before disinfection).
- Page 62 Clean and disinfect the lancing device To clean the lancing device To disinfect the lancing device: thoroughly wipe the entire 1. Take another disinfecting wipe and wipe the lancing device surface of the lancing device thoroughly (note: all blood and body fluids should be cleaned with disinfecting wipes to from surface before disinfection).
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Page 63: Error Messages And Troubleshooting
Error messages and troubleshooting Error 0: Strip damage Error 1: Battery Error 2: Sampling The inserted test strip has been The battery symbol Do not apply the blood to the used or damaged. Er1 symbol appear and the sample port of the test strip meter will not function when the before the sample symbol Please use a new test strip. - Page 64 13 or call your local Ypsomed customer service for support (see page 72). This error message can also indicate that you may have used the wrong test strips.
- Page 65 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 customer service (see page 72).
- Page 66 (see pairing process and make sure that the page 24). passcode provided by the meter is entered If the meter still does not work, please immediately on the mobile device. contact your local Ypsomed customer service (see page 72).
- Page 67 For instruction please consult your user In order to get accurate test results, please test at a temperature between 6 – 44 °C. When manual and/or contact your local Ypsomed customer the temperature is below 6 °C or above 44 °C, service (see page 72).
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Page 68: Technical Specifications
Technical specifications Measurement technology Electrochemical sensor GDH-FAD Reference device Olympus AU400 Measurement calibration Plasma Sample Capillary, 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 1 000 measurements... - Page 69 Power supply 2 CR2032 batteries Meter battery life 1 000 measurements Meter dimension 82 × 50 × 15.5 mm Meter weight 59 ± 5 g Monitor LCD display Meter storage conditions -10 – 60 °C Test strip storage conditions 4 – 30 °C, < 90 % relative humidity Data interface Option A: wireless via Bluetooth (transmission range 10 m)
- Page 70 Disposing of the mylife Unio Cara meter, mylife Unio test strips, ™ ™ ™ ™ mylife AutoLance and mylife Lancets ™ ™ ™ During blood glucose measurement, the meter may come into contact with blood. Used meters therefore carry a risk of contamination. Please dispose of your used meter after removing the batteries in compliance with local regulations.
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Page 71: Warranty
Warranty The manufacturer warrants that your mylife Unio Cara blood glucose monitoring system ™ ™ will be free from defects in materials and workmanship for five years from the date of purchase. This warranty does not apply to the performance of a mylife Unio Cara blood glucose ™... -
Page 72: Customer Service
Unio products, please contact your local Ypsomed customer service: ™ ™ AT Ypsomed GmbH, Am Euro Platz 2, AT – 1120 Wien Kostenlose Service-Hotline: 00800 55 00 00 00 info@ypsomed.at, www.mylife-diabetescare.at BE Ypsomed BVBA, Researchdreef 12, BE – 1070 Brussel Ypsomed SPRL, Allée de la Recherche 12, BE –... - Page 73 FR Ypsomed S.A.S, 44 rue Lafayette, FR – 75009 Paris Service clientèle: 0800 883058, info@ypsomed.fr, www.mylife-diabetescare.fr IN Ypsomed India Pvt Ltd., 10/61/1-F, Kirti Nagar Industrial Area, IN – New Delhi - 11015 Customer care: 099999 75157, 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...
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Page 74: Description Of Symbols Used
Description of symbols used Manufacturer EU Representative 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... -
Page 75: Manufacturer
Manufacturer mylife Unio Cara meter, mylife Unio test strips, mylife ControlGDH control solution ™ ™ ™ ™ ™ Manufacturer: Bionime Corporation No. 100, Sec. 2, Daqing St., South Dist., Taichung City 40242, Taiwan The products comply with In-Vitro Diagnostic Directive 98/79/EC (CE 0197). EU Representative: Bionime GmbH, Tramstrasse 16, 9442 Berneck, Switzerland mylife AutoLance... - Page 76 Bionime Corporation No. 100, Sec. 2 Daqing St., South Dist. 40242 Taichung City 0197 Taiwan Bionime GmbH Manufactured for Tramstrasse 16 Ypsomed Distribution AG 9442 Berneck 3401 Burgdorf Switzerland Switzerland info@bionime.ch www.mylife-diabetescare.com Ypsomed Distribution AG Brunnmattstrasse 6 3401 Burgdorf Switzerland info@ypsomed.com...