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Ypsomed Unio User Manual

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  • Page 2 Preface Thank you for choosing the mylife Unio blood glucose monitoring system. ™ ™ Please read this user guide thoroughly before testing your blood glucose. It provides all the information you need to use the product. The mylife Unio blood glucose meter ™...
  • Page 3 The mylife Unio 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 73).

  • Page 4: Table Of Contents

    Table of contents First steps mylife Unio blood glucose meter ™ ™ Intended use Edit marker: how to add/change markers of your results mylife Unio package contents ™ ™ mylife Unio blood glucose meter Records: recalling test results ™ ™...
  • Page 5 AutoLance lancing device Further informations ™ ™ Overview Precautions Handling Limitation of the mylife Unio meter ™ ™ Alternative site testing (AST) Maintenance and cleaning the meter Error messages and trouble shooting mylife Unio test strips ™ ™ Technical specifications...

  • Page 6: Intended Use

    Intended use The mylife Unio 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 7: Mylife Unio Package Contents

    Unio package contents ™ ™ 1 mylife SoftCase ™ 2 mylife Unio blood glucose meter ™ ™ (with 2 CR2032, 3 volt batteries installed) 3 Vial with mylife Unio test strips (10 pcs) ™ ™ 4 mylife AutoLance lancing device ™...

  • Page 8: Mylife ™ Unio ™ Blood Glucose Meter

    Unio 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. Left and right Double click: return to home scroll buttons screen.
  • Page 9 2D barcode with serial number Battery cover CR2032 Slide cover batteries downwards to change batteries. Mini USB port For instructions For data transfer to the PC/Mac see page 48. (data management).

  • Page 10: First Start-Up

    First start-up Before you can use the mylife Unio BGMS, ™ ™ you first need to pull out the battery isolation tap and make some settings. Power on press Select your language Set the date format. for 0.5 second. preferences and scroll down...
  • Page 11 Set the day/month/year. Switch and confirm with Switch and confirm with...
  • Page 12 Set the time format Set the hour and minute. Switch and confirm with (24/12 hour) and confirm with...
  • Page 13 When changing batteries, the start-up procedure may be repeated. Please see page 48 for further instructions to keep settings when changing batteries Now you are ready to use the mylife Unio BGMS. ™ ™...

  • Page 14: How To Perform A Blood Glucose Measurement

    How to perform a blood glucose measurement Take off the depth-adjustable Insert a new disposable lancet Twist off and set aside the cap by turning smoothly in firmly into lancet carrier. protective cover of the dispos- opposite directions. able lancet.
  • Page 15 Replace the depth-adjustable Choose the penetration depth Wash and dry your hands. cap by smoothly turning into by turning the cap. 1 – 3 for soft or thin skin; 4 – 5 for average lock position. skin; 6 – 7 for thick or calloused skin.
  • Page 16 Take one test strip from the Insert the test strip into the After a short screen and recognising vial and close the cap of test strip port on the meter. check, the symbol “Apply blood” will the vial immediately. The meter will automatically appear.
  • Page 17 1 Press the security button to unlock the lancing device (keep pressing until pricked). 2 Place the finger against the lancing device and press the finger on the cap. The lancing device has an automatic loading and releasing function Recommended sites for priming necessary.
  • Page 18 Gently squeeze your fingertip to get a drop of blood. Apply the blood drop to the edge of the test strip. When the view 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.
  • Page 19 The “Please wait” symbol will appear for 5 seconds before the Remove the test strip from the meter. test result is displayed. For further information about your test Please follow your local regulations and result, please consult your doctor. discard the used test strip properly. If your test result is below 10 mg/dL or the test strip was not completely filled with blood, "Lo"...

  • Page 20: How To Set A Marker

    How to set a marker The test result is displayed on the screen with time and date in the bottom line. Choose directly between three markers. Choose between the “Before meal” marker, the “After meal” marker and no marker. Confirm with the button.

  • Page 21: Edit Marker: How To Add/Change Markers Of Your Results

    Edit marker: how to add/change markers of your results To add or edit a marker of an existing The last measurement with time and date is now measurement enter the main menu and displayed on the screen. The desired record can be scroll down with the button to “Edit chosen by navigating the up...
  • Page 22 Markers Before meal. You set this marker before you have eaten. After meal. You set this marker after you have eaten. Sport. You set this marker when you are doing sport. Illness. You set this marker when you are sick. Special.
  • Page 23 The list of markers appears. To add or change Settings saved. markers navigate with the up and down buttons and mark the desired markers with the button to confirm. To exit the menu go to “OK” and press the button.
  • Page 24 Menu guidance of the mylife Unio meter ™ ™ In this chapter you To navigate in the menus of the meter use get to know the menu the following buttons: guidance of your meter and how to navigate To scroll up in the menu through the menus.
  • Page 25 In the main menu of your meter you can select the following sub-menus: Records: recalling test results Averages: recalling average calculations of test results Edit marker: add/change markers of test results Alarm: set alarm time Settings: set language/date/time/volume Control test: perform a control solution test...

  • Page 26: Records: Recalling Test Results

    Records: recalling test results The meter is able to store 1,000 test results with time, date and markers 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 27: Averages: Recalling Average Test Results

    Averages: recalling 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 from the results with the control solution test.
  • Page 28 To navigate from one average On the top line the number of calculated days is displayed. The large result to the other, use the number with the mg/dL specification indicates the calculated average of the buttons. measurements during the time and the measured results during the period.
  • Page 29 The average function is related to the time setting. Time and date must be set correctly on your meter to enable correct average calculations. Results: Quantity of the measure- ments within the chosen days. For example, the 14-day average will show no figure if no measurements On the bottom line the number of been performed during this time.

  • Page 30: Alarm: How To Set An Alarm

    Alarm: how to set an alarm The mylife Unio meter has four different Choose the alarm with the To set the hour of the alarm ™ ™ alarms that can be individually set. To set scroll up and down . When...
  • Page 31 To set the minute of the alarm The alarm can be set daily or On the display an overview of the four scroll up and down only one time. Scroll up alarms appears. Each alarm is specified When the correct minute is down until the desired with time and repeatability mode.

  • Page 32: Settings: Set Language

    Settings: set language In the menu “Settings” you can select In the menu “Language” you have Settings saved. the language, set the date and time as the possibility to choose the language well as choose the volume of your meter. (English, German, French and Italian) Scroll down with the button to the...

  • Page 33: Settings: Set Date

    Settings: set date In the menu “Date” you have the possibility You can choose two different date formats to set the date of your meter. Scroll down with (dd/mm/yyyy) or (mm/dd/yyyy). To choose the button to the menu “Date” and confirm date format scroll up and down .
  • Page 34 You can select the correct day by scrolling with the up Settings saved. down buttons and confirm with the confirm button. Proceed the same way to set the month and the year.

  • Page 35: Settings: Set Time

    Settings: set time In the menu “Time” you have You have the possibility to select from two the possibility to set the time different time formats. of your meter. Scroll down with Select the desired format (12 hours or button to the menu 24 hours) by scrolling up down.
  • Page 36 The cursor will move down to the time Settings saved. indication. Select your desired hour with the and down buttons. Confirm with the confirm button. Select your desired minute with the up down buttons. Confirm with the button.

  • Page 37: Settings: Set Volume

    Settings: set volume To adjust the volume of Now a volume symbol appears on the display. the meter, select the It can be adjusted with the up and down sub-menu “Volume”. buttons. Confirm with the confirm button. To turn off the sound of the meter, set the volume to mute.

  • Page 38: Quality Control Test

    Quality control test with mylife ControlGDH control solution ™ A quality control test should be performed Control whenever you want to check whether your solution BGMS is working properly or whenever you range mg/dL mmol/L want to practise the testing procedure and Normal 83 –...
  • Page 39 Each time you open a new bottle of control solution, write the discard date on the label. The control solution is good for 3 months after opening the bottle, or until the expiry date printed on the label, whichever comes first. 2017-10 Control solution test results do not represent your blood glucose level.
  • Page 40 To perform a test with control solution scroll down with the button to the menu “Control Test” and confirm by pressing the button.
  • Page 41 Take one test strip from the test strip vial and recap it immediately. Wait for two seconds until Apply the test strip to test strip port. the symbol “Recognising” disappears.
  • Page 42 Before opening the cap of the control solution, shake the bottle well. Open the bottle and place the cap upright on the table. Drip a drop of control solution on the top of the cap. Gently touch the sample entry of the test strip onto the drop of control solution on the top of the cap.
  • Page 43 Clean the top of the cap and replace the cap on the control solution bottle. When you hear a beep (if After five seconds, the test result of the control solution test appears. volume is switched on) please The result will automatically be marked with the control solution marker. wait for the test result.
  • Page 44 BGMS. for more than 6 months. Your control solution is diluted. Contact your local Ypsomed The cap of the test strip vial or the control solution customer service (see page 73). has been left open for a long time.
  • Page 45 Your control solution test results will not be included in the average reading 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 (43 - 111 °F).

  • Page 46: Data Management

    Data management mylife Diabass The mylife Unio blood glucose ™ ™ ™ ® meter has a real Mini USB port With mylife Diabass , data ™ ® and is compatible with 3 different can be transferred from your softwares the mylife...
  • Page 47 diasend mylife SiDiary ® ™ diasend , a web based software package, mylife SiDiary provides you with ® ™ compatible with both PC and Mac an up-to-date tool of diabetes computers, has been developed as a management and telemonitoring. communication service for healthcare in an mylife SiDiary represents a ™...

  • Page 48: Battery Change

    Battery change Your meter is delivered with two CR2032, 3 volt batteries installed. Two new batteries will provide power to perform about 600 tests under normal circumstances. To install the batteries, proceed as follows: To insert/change the batteries of your meter, move the cover on the back of the meter downwards.
  • Page 49 Remove the old batteries. Install the first battery. Be sure to insert the battery the correct way with the + symbol up.
  • Page 50 When changing the batteries without turning off the meter first, the start-up procedure has to be repeated. Changing batteries when meter is turned-off, meter will not reset for one minute. Measurements will not be deleted when changing batteries. Close the contact flap and install the Close the cover on the back second battery.

  • Page 51: Overview

    mylife AutoLance Overview ™ ™ Loading and releasing mechanism Simply press the Penetration depth window cap on the desired penetration site. Choose the penetration depth by turning the cap. Depth-adjustable cap Open the cover to replace the lancet. Mechanics holder To insert the disposable lancet.

  • Page 52: Handling

    Handling of the mylife AutoLance ™ ™ Pull off the depth-adjustable cap. Insert a new disposable lancet Twist off and set aside the firmly into lancet carrier. protective cover of the disposable lancet.
  • Page 53 Replace the depth- Choose the penetration Place the finger against While pressing the safety adjustable cap by depth by turning the cap. the lancing device and button, press your finger smoothly turning into 1 – 3 for soft or thin skin; press the safety button.

  • Page 54: Alternative Site Testing (Ast)

    Select the clear AST cap to perform a measurement on an alternative site testing. AST cap can be ordered at your local customer service. Please contact your local Ypsomed customer service (see page 73).
  • Page 55 Massage the puncture area of the palm or forearm for a few Continue holding the lancing device seconds and immediately after massaging the puncture area, against the puncture site, and gradually press and release the lancing device with the clear cap increase pressure for a few seconds until against it.
  • Page 56 The blood glucose test results of blood samples taken from different sites may vary in certain conditions, such as rapid changes in glucose levels following a drink or a meal, an insulin dose or exercise. In these cases, only the fingertip should be used. DO NOT test on the palm or forearm if you are testing for hypoglycemia (low blood glucose) or hypoglycemia unawareness.

  • Page 57: Mylife ™ Unio ™ Test Strips

    Unio test strips ™ ™ The meter must only be used with 1 Sample entry mylife Unio test strips. The use of other ™ ™ Apply a drop of blood or control solution here. The test requires only 0.7 µL of blood.
  • Page 58 Recap the test vial strip 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 6 months after the first opening. Store the test strips in a cool (4 °C – 30 °C or 39 °F – 86 °F) and dry location (<...
  • Page 59 Make sure your blood sample An insufficient blood sample covers the whole area of the can result in an error message view window to get an (see page 66). If this occurs, accurate test result. repeat the test with a new test strip.
  • Page 60 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 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 test strip using a syringe.

  • Page 61: Precautions

    Precautions Before using the BGMS to test your blood glucose, please read the user guide care- fully. 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.
  • Page 62 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 take a minimum of 0.7 µL to perform the test on 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.

  • Page 63: Limitation Of The Mylife ™ Unio ™ Meter

    Limitations of the mylife Unio meter ™ ™ The BGMS is not intended for serum or plasma testing. For capillary, venous and arterial whole blood testing Do not use this only. meter close to strong Inaccurate test results may be obtained at an altitude electromagnetic of more than about 3,048 meters (10,000 feet).

  • Page 64: Maintenance And Cleaning The Meter

    Maintenance and cleaning the meter 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 38) before doing a blood glucose test to insure that the meter is still functioning correctly. Clean the outside of the meter with a damp cloth and mild soap or detergent.

  • Page 65: Error Messages And Trouble Shooting

    Error messages and trouble shooting You have inserted a used test strip. Please Your BGMS is not functioning properly. insert a new (unused) strip. Please call the nearest service centre (page 73).
  • Page 66 Insert a new strip. The blood sample is too small. Please insert a new strip and repeat the measurement.
  • Page 67 Check the test strip, the contact area may Battery is low, change the batteries. be contaminated.
  • Page 68 Operating temperature is too high or Change the test strip. too low. Go in an area with an ambient temperature between 6 °C – 44 °C or 43 °F – 111 °F and wait for 30 minutes before performing a new test.

  • Page 69: 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 Measuring range 10 – 600 mg/dL Test time 5 sec. Memory capacity 1,000 measurements Power saving...
  • Page 70 Operating temperature 6 ºC – 44 ºC Operating relative humidity < 90 % 20 ~ 70 % when blood glucose ≤ 200 mg/dL, Heamatocrit 20 ~ 60 % when blood glucose > 200 mg/dL Power supply 2 CR2032 batteries Meter battery life 600 measurements Meter dimension 71.5 x 39.5 x 14.0 mm...

  • Page 71: Disposing Of The Mylife ™ Unio ™ Meter

    Disposing of the mylife Unio 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 infection. Please dispose of your used meter after removing the batteries –...

  • Page 72: Warranty

    Warranty The manufacturer warrants that your mylife Unio BGMS 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 BGMS that has been ™...

  • Page 73: Customer Service

    DK Ypsomed Denmark, Postboks 421, Ulrikkenborg Plads 1, 2800 Kongens Lyngby NO Ypsomed, Papirbredden, Grønland 58, 3045 Drammen SE Ypsomed AB, Adolfsbergsvägen 31, plan 4 168 67 Bromma IN Ypsomed India Pvt Ltd, 10/61/1-F, Kirti Nagar Industrial Area, New Dehli - 11015 Ypsomed AB, Eteläinen Salmitie 1, 02430 Masala...

  • Page 74: Description Of Used Symbols

    Description of symbols used EU Representative Manufacturer EC REP For in vitro diagnostic use For single use only IV D Use by Temperature limitations Sterilised using irradiation Caution (consult instructions for use and warnings) CE Mark with number of Notified Body CE Mark Consult instructions for use Lot number...

  • Page 75: Manufacturer

    Manufacturer mylife Unio 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).
  • Page 76 BIONIME CORPORATION No. 100, Sec. 2, Daqing St. 0197 South Dist., Taichung City 40242 Taiwan Manufactured for Ypsomed Distribution AG CH-3401 Burgdorf, Switzerland www.mylife-diabetescare.com Bionime GmbH Tramstrasse 16 CH-9442 Berneck / Switzerland E-mail: info@bionime.ch www.mylife-diabetescare.com...

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