Ypsomed Unio User Manual Download Page 63

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The BGMS is not intended for serum or plasma testing.
For capillary, venous and arterial whole blood testing
only.

Inaccurate test results may be obtained at an altitude
of more than about 3,048 meters (10,000 feet).

Severe dehydration may cause inaccurately low results.

The glucose test may be invalid if abnormally
high concentrations of the following are present:
Ascorbic acid

≥

5 mg/dL

Xylose

≥

20 mg/dL

Uric Acid

≥

20 mg/dL

If the mylife

™

Unio

™

meter and mylife

™

Unio

™

test strips

are exposed to a considerable variation in temperature,
please wait 30 minutes before measurement.

Limitations of the mylife

™

Unio

™

meter

Do not use this
meter close to strong
electromagnetic
radiation sources, in
order to avoid inter-
ference with normal
operation.

Keep the meter free
of dust, water or any
liquid.

Summary of Contents for Unio

Page 1: ......

Page 2: ...e Unio blood glucose meter must only be used with mylife Unio test strips and mylife ControlGDH control solution The use of other test strips or control solutions may lead to incorrect test results It is recommended that the blood glucose should be monitored regularly The mylife Unio blood glucose monitoring system is accurate and easy to use and is therefore your reliable assistant for diabetes m...

Page 3: ...dual They must not be used on more than one person due to the risk of cross infection 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: ...nio blood glucose meter Edit marker how to add change markers of your results 21 Records recalling test results 26 Averages recalling average test results 27 Alarm how to set an alarm 30 Settings set language 32 Settings set date 33 Settings set time 35 Settings set volume 37 Quality control test mylife ControlGDH control solution 38 Data management 46 Battery change 48 Table of contents ...

Page 5: ...essages and trouble shooting 65 Technical specifications 69 Disposing of the mylife Unio meter test strips and lancets 71 Warranty 72 Customer service 73 Description of used symbols 74 Manufacturer 75 mylife AutoLance lancing device Overview 51 Handling 52 Alternative site testing AST 54 mylife Unio test strips Handling 57 ...

Page 6: ...to use the system correctly Our customer support staff are available to assist you Healthcare professionals may use the mylife Unio blood glucose monitoring system for surveillance of the blood glucose levels of patients in medical facilities For a better understanding of this user guide hereinafter the mylife Unio blood glucose monitoring system will be referred to as BGMS the mylife Unio blood g...

Page 7: ...ase 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 5 Disposable mylife Lancets 10 pcs 6 mylife Unio user guide 7 Quick Guide 8 Diabetes diary ...

Page 8: ...play Shows test results messages and all other relevant information Left and right scroll buttons For operating the meter please consult the details in the following sections Main confirm button Single click confirm Double click return to home screen 2 second click power off 0 5 second click power on ...

Page 9: ...9 Battery cover Slide cover downwards to change batteries For instructions see page 48 Mini USB port For data transfer to the PC Mac data management 2x CR2032 batteries 2D barcode with serial number ...

Page 10: ...he mylife Unio BGMS you first need to pull out the battery isolation tap and make some settings Power on press for 0 5 second Select your language preferences and scroll down to OK and press Set the date format First start up ...

Page 11: ...11 Set the day month year Switch and confirm with Switch and confirm with ...

Page 12: ...12 Set the hour and minute Switch and confirm with Set the time format 24 12 hour and confirm with ...

Page 13: ...13 Now you are ready to use the mylife Unio BGMS When changing batteries the start up procedure may be repeated Please see page 48 for further instructions to keep settings when changing batteries ...

Page 14: ...adjustable cap by turning smoothly in opposite directions Twist off and set aside the protective cover of the dispos able lancet Insert a new disposable lancet firmly into lancet carrier How to perform a blood glucose measurement ...

Page 15: ...e the depth adjustable cap by smoothly turning into lock position Wash and dry your hands 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 ...

Page 16: ...nd recognising check the symbol Apply blood will appear 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 turn on 9 ...

Page 17: ...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 no priming necessary ...

Page 18: ...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 If the view window of the test strip is not completely filled with blood the measurement will not start Discard the test strip and repeat the test with a new one ...

Page 19: ...ayed For further information about your test result please consult your doctor If your test result is below 10 mg dL or the test strip was not completely filled with blood Lo will appear on the screen If your test result is above 600 mg dL Hi will appear on the screen Please repeat your test with a new strip If you still get a Lo or Hi result you should immediately contact healthcare professional ...

Page 20: ...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 How to set a marker ...

Page 21: ... to Edit marker You are able to choose 5 markers for the same measurement Confirm the selection with the button The last measurement with time and date is now displayed on the screen The desired record can be chosen by navigating the up and down buttons When the desired record is displayed on the screen confirm the highligted menu Edit marker with the button ...

Page 22: ...rker 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 You set this marker for a special event Markers ...

Page 23: ...e list of markers appears To add or change 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 Settings saved ...

Page 24: ...menus Menu guidance of the mylife Unio meter To scroll up in the menu To scroll down in the menu Multifunction control button Single click to confirm the selection you have made Double click return to home screen Long click power on off To navigate in the menus of the meter use the following buttons ...

Page 25: ...llowing 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: ...s 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 To recall your measured records go to the main menu and scroll down to the sub menu Records ...

Page 27: ...r 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: ...he other use the and buttons On the top line the number of calculated days is displayed The large number with the mg dL specification indicates the calculated average of the measurements during the time and the measured results during the period ...

Page 29: ...verage 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 been performed during this time ...

Page 30: ...idually set To set an alarm navigate in the main menu with the up and down buttons to the menu Alarm Choose the alarm with the and buttons and confirm by pressing the button To set the hour of the alarm scroll up and down When the correct hour is displayed confirm the hour by pressing the button ...

Page 31: ...ose the selection with the confirm button To set the minute of the alarm scroll up and down When the correct minute is displayed confirm by pressing the button On the display an overview of the four alarms appears Each alarm is specified with time and repeatability mode If you have set the alarm it will show the alarm symbol in the home screen ...

Page 32: ... the button to the menu Settings and confirm by pressing the button In the menu Language you have the possibility to choose the language English German French and Italian of your meter To select the language of the meter you can scroll up and down and confirm your selection by pressing the button Settings set language Settings saved ...

Page 33: ... mm dd yyyy To choose the date format scroll up and down When your desired format is displayed confirm by pressing the button In the menu Date you have the possibility to set the date of your meter Scroll down with the button to the menu Date and confirm by pressing the button ...

Page 34: ...34 You can select the correct day by scrolling with the up and down buttons and confirm with the confirm button Proceed the same way to set the month and the year Settings saved ...

Page 35: ...rent time formats Select the desired format 12 hours or 24 hours by scrolling up and down Confirm by pressing the button In the menu Time you have the possibility to set the time of your meter Scroll down with the button to the menu Time and confirm by pressing the button ...

Page 36: ...ill move down to the time indication Select your desired hour with the up and down buttons Confirm with the confirm button Select your desired minute with the up and down buttons Confirm with the button Settings saved ...

Page 37: ... on the display It can be adjusted with the up and down buttons Confirm with the confirm button To turn off the sound of the meter set the volume to mute It is not possible to mute the alarms To adjust the volume of the meter select the sub menu Volume ...

Page 38: ...working properly or whenever you want to practise the testing procedure and check correct procedure Please use control solution tested with 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 Control solution range Normal High mmol L 4 ...

Page 39: ...e 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 Control solution test results do not represent your blood glucose level Example of expiry date 2017 10 ...

Page 40: ...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: ...41 1 2 Take one test strip from the test strip vial and recap it immediately Apply the test strip to test strip port Wait for two seconds until the symbol Recognising disappears ...

Page 42: ...l 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: ...ill 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 When you hear a beep if volume is switched on please wait for the test result You will see the countdown mode on the screen ...

Page 44: ...n results are out of range Your control solution has expired or has been opened for more than 3 months Your test strips have expired or have been opened for more than 6 months 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 contro...

Page 45: ...ol solution test is 6 44 C 43 111 F 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 s degeneration Doing this could potentially contaminate the meter via the test strip port Do not touch the nozzle of the control solution bottle If you hav...

Page 46: ...oftware Because of the USB plug and play function you just need a conventional mini USB cable to manage your data transfer mylife Diabass With mylife Diabass data can be transferred from your mylife Unio blood glucose meter to the PC and prepared and analysed clearly With the mylife Diabass it is easy and affordable to analyse your blood glucose level mylife Diabass is sold separately ...

Page 47: ...ces and quality of life of patients diasend provides a complete technical solution for transmitting storing and monitoring patients glucose readings diasend is sold separately mylife SiDiary mylife SiDiary provides you with an up to date tool of diabetes management and telemonitoring mylife SiDiary represents a product designed for diabetics by diabetics mylife SiDiary is sold separately ...

Page 48: ...e cover on the back of the meter downwards 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 ...

Page 49: ...49 2 3 Remove the old batteries Install the first battery Be sure to insert the battery the correct way with the symbol up ...

Page 50: ... 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 second battery Close the cover on the back of the meter Move the cover upwards ...

Page 51: ...s 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 Mechanics holder To insert the disposable lancet Safety button To prevent from accidential releasing ...

Page 52: ...2 1 3 2 Handling of the mylife AutoLance Pull off the depth adjustable cap Twist off and set aside the protective cover of the disposable lancet Insert a new disposable lancet firmly into lancet carrier ...

Page 53: ...ton press your finger smoothly on the cap The lancing device auto matically loads and releases 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 ...

Page 54: ...ite testing AST cap can be ordered at your local customer service Please contact your local Ypsomed customer service see page 73 The AST function can enable you to test the blood glucose on other sites than the fingertips and can benefit to avoid repeated pricking in the fingertips and reduces with pain ...

Page 55: ...ds 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 ...

Page 56: ... 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 Fingertip samples can show rapid changes of glucose faster than palm or forearm samples As the blood flow taken from forearm or palm is slower than from the fingertip we recommend using the lancing device with clear cap AST cap for testing at sites...

Page 57: ...ng blood sample It gradually turns red as it fills with blood 4 Indication symbol Insert test strip with indication symbol upfront and down towards meter 5 Hand bar Grip here to insert test strip into meter 6 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 res...

Page 58: ...d 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 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 ...

Page 59: ...your blood sample covers the whole area of the view window to get an accurate test result An insufficient blood sample can result in an error message see page 66 If this occurs repeat the test with a new test strip ...

Page 60: ...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 Doing so may contaminate the meter or cause damage ...

Page 61: ...incorrect results If the meters and test strips are exposed to a considerable temperature variation please wait 30 minutes before performing the measurement Dispose of used batteries properly according to your 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 met...

Page 62: ...orm 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 A sample size below 0 7 µL may lead to an error message see page 66 If this occurs repeat the test with a new test strip ...

Page 63: ...be invalid if abnormally high concentrations of the following are present Ascorbic acid 5 mg dL Xylose 20 mg dL Uric Acid 20 mg dL If the mylife Unio meter and mylife Unio test strips are exposed to a considerable variation in temperature please wait 30 minutes before measurement Limitations of the mylife Unio meter Do not use this meter close to strong electromagnetic radiation sources in order t...

Page 64: ... 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 Do not wet the test strip port Always keep the metal contact points of the test strip entry point clean If any dust or impurities are present please clean with a small soft brush otherwise the meter may not work correctly when you insert a test str...

Page 65: ...65 Error messages and trouble shooting You have inserted a used test strip Please insert a new unused strip Your BGMS is not functioning properly Please call the nearest service centre page 73 ...

Page 66: ...66 Insert a new strip The blood sample is too small Please insert a new strip and repeat the measurement ...

Page 67: ...67 Check the test strip the contact area may be contaminated Battery is low change the batteries ...

Page 68: ...68 Operating temperature is too high or 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 Change the test strip ...

Page 69: ...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 on Technical specifications ...

Page 70: ...eight 50 5 0 g Monitor LCD display Data manager Mini USB port Meter storage conditions 10 60 ºC 14 140 ºF Test strip storage conditions 4 30 ºC 39 86 ºF 90 relative humidity Meter data transmission management Meter data can be transmitted to a computer with the mini USB to USB A type USB cable The data is managed by the mylife Diabass diasend and mylife SiDiary software Disclaimer The third party ...

Page 71: ... of infection Please dispose of your used meter after removing the batteries following the disposal regulations applicable in your country For information about correct disposal please contact your local authority Used test strips and lancets are potentially infected Please dispose the used test strip and or the puncture proof or biohazard container for your used lancets according to your local re...

Page 72: ... of purchase This warranty does not apply to the performance of a mylife Unio BGMS that has been altered misused tampered or abused in any way This warranty applies only to the original purchaser of the mylife Unio meter This warranty does not apply for any damage caused by the use of other test strips than mylife Unio test strips Warranty ...

Page 73: ...Ypsomed GmbH Höchster Straße 70 DE 65835 Liederbach AT Ypsomed GmbH Am Euro Platz 2 1120 Wien FR Ypsomed S A S 18 20 rue Soleillet FR 75020 Paris UK Ypsomed Ltd 1 Park Court Riccall Road Escrick YO19 6ED NL Ypsomed BV P O Box 1190 3430 BD Nieuwegein DK Ypsomed Denmark Postboks 421 Ulrikkenborg Plads 1 2800 Kongens Lyngby NO Ypsomed Papirbredden Grønland 58 3045 Drammen SE Ypsomed AB Adolfsbergsväg...

Page 74: ...e For single use only Reference number Use by Temperature limitations Lot number Serial number Sterilised using irradiation Caution consult instructions for use and warnings CE Mark CE Mark with number of Notified Body Description of symbols used Separate collection of electrical and electronic equipment ...

Page 75: ...nce lancing 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 EU Representative Bionime GmbH Tramstrasse 16 9442 Berneck Switzerland Disposable mylife lancet Manufacturer SteriLance Medical Inc No 68 Litanghe Road Xiangcheng Suzhou China 215133 Product complied with Medical Device Direct...

Page 76: ...No 100 Sec 2 Daqing St South Dist Taichung City 40242 Taiwan 0197 10043126 de fr it en V02 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 125 70mm ...

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