B. Braun Omnitest 5 Manual
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B. Braun Omnitest 5 Manual

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Blood Glucose Monitoring System

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  • Page 1 Omnitest ® Blood Glucose Monitoring System...
  • Page 3 Important notes The Omnitest® 5 system provides a quick and easy way to measure the blood glucose level. It can be used for self- monitoring of blood glucose levels by patients with diabetes. Omnitest® 5 is not intended for any purpose other than measu- ring the blood glucose level and is intended for use exclusively with fresh capillary or venous whole blood samples.

  • Page 4: Table Of Contents

    Table of Contents Overview Omnitest® 5 Set Blood glucose meter Omnitest® 5 Display symbols Test strips Omnitest® 5 Lancing device Omnican® Lance Measuring blood glucose Preparing for the measurement Collecting blood with the lancing device Measuring blood glucose Marker function and display Target level deviation indicator Lighting the display Stored readings...
  • Page 5 Settings Time and date Acoustic signal Timer Target level Alarms Exit settings Functional check Check strip Control solution Appendix Error messages and troubleshooting Maintaining your Omnitest® 5 Changing batteries Technical data and tips Conversion table mg/dL – mmol/L...

  • Page 6: Overview

    Overview Nutzung...
  • Page 7 Contents Omnitest® 5 Set Blood glucose meter Omnitest® 5 Display symbols Test strips Omnitest® 5 Lancing device Omnican® Lance...

  • Page 8: Omnitest® 5 Set

    Omnitest® 5 Set Components of the Omnitest® 5 Set: Protective meter case „ „ Omnitest® 5 blood glucose meter incl. 2 batteries „ „ Omnitest® 5 test strips „ „ Omnican® Lance lancing device with „ „ Omnican® Lance soft lancets Check strip „...
  • Page 9 The blood glucose meter case offers many benefits for daily use: You can leave the meter in the case when measuring. „ „ All functions are easily accessible when in the case. The lancing device has a fixed place in the pouch and can „...

  • Page 10: Blood Glucose Meter Omnitest® 5

    Blood glucose meter Omnitest® 5 Front Illuminated test strip port Eject button Illuminated display Up and Down button ON/OFF and selection button...
  • Page 11 Back Product label Battery cover Strap holder Data transfer port (Micro-USB port)

  • Page 12: Display Symbols

    Display symbols Symbol Meaning Drop flashing – Omnitest® 5 is ready for measuring. Drop lit up – Test was performed. Test was performed with control solution. Test was preprandial (before meal). Test was postprandial (after meal). Timer (Reminder for follow-up test) is activated. Test is associated with a special event (e.g.
  • Page 13 Symbol Meaning Unit of measure display. NOTE: The unit of measure is preset at the factory and cannot be changed. Displaying stored readings. Up to 500 readings can be stored. Display of average levels. The average levels for 7 days, 30 days and 90 days are displayed.

  • Page 14: Test Strips Omnitest® 5

    Test strips Omnitest® 5 Use of Omnitest® 5 test strips For accurate analysis of your blood glucose level, the Omnitest® 5 blood glucose meter must be used with the Omnitest® 5 blood glucose test strips. Opening of the measuring chamber Confirmation window Meter contacting leads Auto-coding label...
  • Page 15 Prior to first use, check that the vial is undamaged and „ „ closed. Store the test strips in the original vial in a cool, dry place „ „ between +2 °C to +30 °C (+36 °F to +86 °F). Close the vial cap immediately after removing a test strip and „...

  • Page 16: Lancing Device Omnican® Lance

    Lancing device Omnican® Lance Use of Omnican® Lance lancing device In combination with Omnican® Lance soft lancets, the Omnican® Lance lancing device is your reliable partner for a soft blood collection. Dialable tip with numbers for adjusting penetration depth Recessed grips Window Release button...
  • Page 17 Use a new sterile Omnican® Lance soft lancet for blood „ „ collection after every use to ensure as little pain as possible. If used multiple times, the tip of the lancet becomes in- „ „ creasingly blunt and supports the formation of calluses as well as the risk of infection.

  • Page 18: Measuring Blood Glucose

    Measuring blood glucose...
  • Page 19 Contents Preparing for the measurement Collecting blood with the lancing device Measuring blood glucose Marker function and display Target level deviation indicator Lighting the display...

  • Page 20: Preparing For The Measurement

    Preparing for the measurement Cleanliness The easiest way of collecting a blood drop is by firstly washing the hands with warm and soapy water, let them dry completely afterwards. This supports blood circulation in the finger tips. The puncture site can alternatively be wiped with an alcohol- soaked swab.
  • Page 21 Blood collection Prepare the lancing device and lancet. Use a new sterile lancet for every blood sample. The lancing device is determined for one's personal use only or for use with only one patient since its tip may be contaminated after use. Further information on blood collection can be found starting on page 22.

  • Page 22: Collecting Blood With The Lancing Device

    Collecting blood with the lancing device Preparing the lancing device Unscrew the cap of the Omnican® Lance device. Firmly insert a new Omnican® Lance soft lancet into the lancet holder. Remove the protective cap from the Omnican® Lance soft lancet carefully in straight direction. Take care not to harm the delicate tip.
  • Page 23 Screw the cap of Omnican® Lance on the device again. The dialable tip of Omnican® Lance provides 7 finely graduated settings of penetration depths. Setting 1 is for most shallow, setting 7 for deepest penetration depth. Choose the penetration depth that is most suitable for your personal condition of skin: for soft or thin skin, for normal skin, for thick or calloused skin.
  • Page 24 Collecting blood with the lancing device Loading the lancing device To load the lancing device, push the slide for loading backwards. You can hear that the tensioning spring snaps into place whilst the window turns red. The Omnican® Lance lancing device is now ready to use.
  • Page 25 Releasing the lancing device Take the Omnican® Lance lancing device and place it on the side of your finger tip. The device should lay flatly and without too much pressure against the surface of your skin. Press the release button and lift off the lancing device. It is less painful if you use the side of your fingertip for puncturing.
  • Page 26 Collecting blood with the lancing device Removing the used lancet To remove the Omnican® Lance soft lancet, unscrew the cap of the Omnican® Lance lancing device. Push the lancet ejector with your thumb forward until the lancet is com- pletely ejected. NOTE For safety reasons and to prevent from cross-contamina- tion, dispose of the used lancet in a suitable container for...
  • Page 27 Cleaning the lancing device The Omnican® Lance device may only be wiped on the outside with a mild soap and water solution. You may additionally unscrew the cap to clean the cap inside. Leave the device to dry properly afterwards. NOTE Replace your Omnican®...

  • Page 28: Measuring Blood Glucose

    Measuring blood glucose Inserting the test strip Remove a test strip from the test strip vial and check it for any damage. Close the vial again immediately to protect the remaining test strips from moisture. Insert the test strip into the meter unit as far as it will go, without bending the test strip.
  • Page 29 Display test Every time the test strip is inserted and the device switches on, a self-test of the electronics occurs. The entire display is shown for 3 seconds to check the display elements. If there is a problem, an error message appears. NOTE The battery segment is displayed as part of the display test.
  • Page 30 Measuring blood glucose Code detection The test strip code detection occurs automatically and is displayed for checking. Check to ensure the codes match between the test strip vial and the display. NOTE If the code numbers do not match, the blood glucose will not be measured accurately.
  • Page 31 Ready to measure If the blood symbol is flashing on the display, the Omnitest® 5 is ready to measure. Date and time are displayed on the lower edge. NOTE The meter switches off after 3 minutes automatically if no test was performed with the test strip. When this happens, the test strip must be reinserted.
  • Page 32 Measuring blood glucose Applying blood Touch your finger to the tip of the Omnitest® 5 test strip. Ensure that blood is not applied from above. The measurement chamber of the test strip will draw automa- tically the blood of your finger. Your finger should remain still, until the confirmation window is completely filled.
  • Page 33 Measuring process After a sufficient volume of blood has been absorbed into the test strip, a signal beeps and the test starts automatically. Remove your finger from the test strip as soon as you hear the "beep". NOTE Do not add blood to the test strip after the "beep” sound. Ensure that no blood flows from the test strip into the device.
  • Page 34 Measuring blood glucose Measuring process During the measuring process, the remaining seconds are displayed on the display until it has ended. The result appears after 5 seconds.
  • Page 35 Reading display The reading is displayed in mg/dL (milligrams of glucose per decilitre of blood). You cannot alter the unit of measure. The Omnitest® 5 meter can display results between 10 and 600 mg/dL. NOTE Your meter was preset and is locked to display results in mg/dL.
  • Page 36 Measuring blood glucose Removing the used test strip To remove the test strip from the meter, push the ejector button forwards while the meter is directed downwards. Discard the used test strip and the lancet in accordance with local regulations.

  • Page 37: Marker Function And Display

    Marker function and display Enter marker After testing, press the buttons to select one of the following markers: Test with control solution Test before meal (preprandial) Test after meal (postprandial) Timer activated (Reminder for a follow-up test) General markings (Special circumstances) To select, press the button .
  • Page 38 Marker function and display Mark reading as “Test with control solution” After testing, choose the symbol with . The symbol for the control solution flashes. Confirm your choice with the button . The device switches off.
  • Page 39 Mark the reading as “Test before/after a meal” After testing, choose the symbol with . The symbol for a test before a meal (preprandial) flashes. Confirm by pressing . The device switches off. You additionally have the option to activate the timer (see page 40).
  • Page 40 Marker function and display Activate timer The timer can help to remember a follow-up test after mealtimes. After testing, choose the symbol with Press the button to activate the timer. The timer alarm is preset to one hour after the current test. To lengthen or shorten the preset time, press the button to change it in 15-minute intervals.
  • Page 41 Mark reading as “General Marking” The result is marked to indicate special circumstances or an exceptional reading. More detailed information about this can be noted in your diabetes diary. After testing, choose the symbol with . The symbol for general marking flashes.

  • Page 42: Target Level Deviation Indicator

    Target level deviation indicator Target level deviation indicator By pressing the buttons the target level and deviation from the target level are shown according to your settings. NOTE To display the target level and the deviation from the target level, the target level must be defined and activated in the Omnitest®...

  • Page 43: Lighting The Display

    Lighting the display Lighting the display The display illuminates and the test strip port switches on shortly after inserting the test strip. If nothing else happens, the backlight turns off to reduce power consumption after a short time. By pressing a button, the backlight can be switched back on.

  • Page 44: Stored Readings

    Stored readings...
  • Page 45 Contents Displaying stored readings Transferring readings...

  • Page 46: Displaying Stored Readings

    Displaying stored readings Displaying stored readings When the device is off press the button to bring up your stored readings on the meter. Omnitest® 5 stores 500 readings. The newest reading is displayed first. The button allows you to search for an older reading. After 500 data entries, the oldest readings are replaced by the newest.
  • Page 47 Display of average levels Use the buttons to change between individual stored readings. After the last reading or before the first reading, the calculated average levels are displayed for different time periods consecutively: Average level for 7 days „ „ Average level for 30 days „...

  • Page 48: Transferring Readings

    Transferring readings Data transfer of stored readings Readings can be transferred from the Omnitest® 5 to a computer for further analysis. A PC connection cable (standard USB to micro-USB connector) is needed to be able to use this function. The cable can also be purchased as an accessory. The device cannot be charged via the cable.
  • Page 49 The data transfer proceeds as follows: Connect the PC connection cable to your computer „ „ Then connect your Omnitest® 5 to the PC connection cable „ „ Start the data transfer according to the instructions in the „ „ software Compatible diabetes diary software is required to display your readings.

  • Page 50: Settings

    Settings...
  • Page 51 Contents Time and date Acoustic signal Timer Target level Alarms Exit settings...
  • Page 52 Settings Changing the device settings To change the device settings, press the button and hold for more than 3 seconds until the symbol SEt flashes. When adjusting the settings, Settings is continuously shown at the top of the main display. The following pages show the setting options that can be selected for the blood glucose meter.

  • Page 53: Time And Date

    Time and date Time and date Press the button to set the hours, minutes, year, month and day one after another. With the buttons you can change the flashing value.

  • Page 54: Acoustic Signal

    Acoustic signal Acoustic signal Acoustic signals (bEEP) are activated by default on the Omnitest® 5. Press the button to change the status from On to OFF. Confirm your choice with the button...

  • Page 55: Timer

    Timer Timer Use the timer as a reminder for a follow-up test after a meal. The preset alarm time for the timer is one hour. To lengthen or shorten the preset alarm time, push the button to change it in 15-minute intervals. Press the button to save the alarm time for the timer.

  • Page 56: Target Level

    Target level Display and setting target level The display of the target level and deviation from the target level can generally be switched on or off. If the display is activated, you can change the preset target level of 100 mg/dL using the buttons to increase or reduce it.

  • Page 57: Alarms

    Alarms Switch off all alarms You can deactivate all alarms in the Omnitest® 5 without deleting them. between On and OFF and Alternate with the buttons confirm your choice with the button If an alarm time is set, but the alarm sound is switched off, OFF appears.
  • Page 58 Alarms Setting alarms In the Omnitest® 5, up to 5 alarms can be set, which can be individually activated/deactivated. An activated alarm signals every day at the preset time. Deactivated alarms are not deleted.
  • Page 59 Select with the buttons an alarm and confirm your choice with the button to activate it. Afterwards you can use the buttons to set the alarm time and save this time with the button before setting the next alarm. NOTE Press any button to end an alarm.

  • Page 60: Exit Settings

    Exit settings Exit settings After exiting the settings, the display flashes End and the Omnitest® 5 switches off. If you wish to alter more settings, start the settings again. NOTE You can exit device settings at any time by holding the button for longer than 3 seconds.

  • Page 62: Functional Check

    Functional check...
  • Page 63 Contents Check strip Control solution...

  • Page 64: Check Strip

    Check strip Monitoring with the check strip The check strip verifies whether the Omnitest® 5 meter is working properly. Insert the check strip into the meter. The meter switches on automatically.
  • Page 65 If an error message appears on the display, repeat the procedure 2 to 3 times. If an error message continues to be displayed, the meter may not be used for measuring blood glucose levels. Contact your local representative for warranty services.

  • Page 66: Control Solution

    Control solution Verification with control solution The control solution Omnitest® 5 Control verifies that the blood glucose monitoring system is functioning properly. The control solution should be used in the following cases: For any suspected malfunction of the device or test strips „...
  • Page 67 Preparation of the verification Control solution tests must be performed within a temperature range of +20 °C to +25 °C (+68 °F to +77 °F). If the control solution is cold, do not use it until it has warmed to room temperature. Insert a test strip as far as possible into the meter without bending it.
  • Page 68 Control solution Applying the control solution Gently shake the control solution. Remove the cap and squeeze the container. Discard the first drop and wipe the tip of the bottle with a clean tissue to ensure an accurate result. Squeeze the container again to release a drop. Apply a drop of control solution to a clean and none absorbing base.
  • Page 69 You will hear the signal tone when the test strip is completely filled with the control solution. The meter counts down from 5 to 1 and then displays the result. Compare the displayed result with the range printed on the test strip vial.
  • Page 70 Control solution Mark reading When you have performed a test with control solution, you can now use the button to mark the measured level with the symbol confirm it. NOTE Control solution labelled results are not included in the calculation of average levels.
  • Page 71 Results that fall outside of the range can be caused by one or more of the following reasons: Error when performing the test „ „ Control solution was not shaken „ „ Expired or contaminated control solution „ „ Control solution too warm or too cold „...

  • Page 72: Appendix

    Appendix Nutzung...
  • Page 73 Contents Error messages and troubleshooting Maintaining your Omnitest® 5 Changing batteries Technical data and tips Conversion table mg/dL – mmol/L...

  • Page 74: Error Messages And Troubleshooting

    Error messages and troubleshooting Error message Cause There is a problem with the meter. An incorrect signal from the check strip occurred. The error message may have been caused by a used or wet test strip. There was not enough blood or control solution applied.
  • Page 75 What to do Remove both batteries and insert them again. Repeat the test with the check strip. If the error message continues to be displayed, the meter must be replaced. Repeat the test with a new test strip. Repeat the test with a new test strip and sufficient volume of blood or control solution.
  • Page 76 Error messages and troubleshooting Error message Cause There is a problem with automatic code detection. The ambient temperature is too high or too low. There is a problem with automatic code detection. The Omnitest® 5 contains no readings.
  • Page 77 What to do Repeat the test with a new test strip. If the problem persists, contact the B. Braun representative in your area. Put the meter in a location within the operating temperature range (+10 °C to +40 °C / +50 °F to +104 °F) for at least 10 minutes and repeat the test.
  • Page 78 Error messages and troubleshooting Error message Cause The reading is above 600 mg/dL. The reading is below 10 mg/dL. Low battery voltage indicator. The battery symbol is displayed during use. The battery voltage is no longer sufficient to turn on the Omnitest® 5. The battery symbol flashes if a button is pushed or if a test strip is inserted.
  • Page 79 What to do In case of doubt with regard to the blood glucose level, check the meter with the control solution. If the result is normal, re-test with a blood sample 2 to 3 times. If the (high) message persists, please consult a physician promptly for assistance.
  • Page 80 Error messages and troubleshooting Problem Cause Different readings in The other device has been calibrated comparison to another to whole blood while the Omnitest® 5 is device. calibrated to plasma. The blood samples were not collected at the same time. The puncture site was not cleaned.
  • Page 81 Perform a test with the control solution or the check strip. Repeat the test with a new test strip. Test with control solution. Repeat the test with a new test strip. If the problem persists, contact your retailer or B. Braun representative in your area.

  • Page 82: Maintaining Your Omnitest® 5

    Maintaining your Omnitest® 5 Cleaning Wash and dry your hands before use to prevent damage to the meter and test strips. The meter should be cleaned with a soft cloth or paper towel if necessary. Meters that come into contact with blood present a potential risk of transmitting infectious diseases.
  • Page 83 Storage Do not store the meter and test strips near open flames or microwave ovens. Strong electromagnetic fields (e.g. from mobile phones, microwave ovens) can interfere with the measurement function. After testing, store the Omnitest® 5 components in its case in a cool dry place out of the reach of children.

  • Page 84: Changing Batteries

    Changing batteries Information on changing the batteries Discharged batteries are shown by the illuminated battery symbol on the top right of the display. Change the batteries immediately when this occurs. The meter requires two 3V lithium batteries (CR2032) that are supplied with the meter.
  • Page 85 After inserting new batteries, all elements are initially shown on the display. After a few seconds, an internal test of the electronics is performed. The numbers shown only represent the internal electronic tests. You will be automatically moved to the settings (SEt). Correct the time setting and date from there.

  • Page 86: Technical Data And Tips

    Technical data and tips Risk of infection and cross-contamination To prevent infections and/or cross-contamination, strictly observe hand hygiene and clean your Omnitest® 5 as well as the corresponding accessories regularly. System limitations For more information on system limitations or factors which could impact test results, please read the Omnitest®...
  • Page 87 Test principle The FAD-glucose dehydrogenase enzyme on the test strips reacts specifically with glucose in blood. The current generated is converted and displayed as a blood glucose value. The Omnitest® 5 system is plasma-calibrated to allow easy comparison of results with laboratory methods. Blood glucose meters which are calibrated against a whole blood method may have different results in comparison to the Omnitest®...
  • Page 88 Technical data and tips Specifications Measurement range 10 – 600 mg/dL Measurement time 5 seconds 500 readings with Memory capacity date, time and additional data between +10 °C and +40 °C Operating temperature (+50 °F and +104 °F) Operating humidity 10 –...
  • Page 89 Symbols and labels Consult instructions for use Use by ... This product fulfils the requirements of Directive 98/79/EC on in vitro diagnostic medical devices In vitro diagnostic medical device Batch code Catalogue number Serial number Temperature limitation Do not reuse Use within 3 or 6 months after first opening Direct current Biohazard.

  • Page 90: Conversion Table Mg/Dl - Mmol/L

    Conversion table mg/dL – mmol/L Blood glucose levels conversion table (mg/dL in mmol/L) mg/dL mmol/L mg/dL mmol/L mg/dL mmol/L 14.4 15.0 15.5 16.1 16.7 18.0 19.4 20.8...
  • Page 91 Conversion factor: 1 mg/dL = 0.0555 mmol/L resp. 1 mmol/L = 18.018 mg/dL 10.0 10.5 11.1 11.7 12.2 12.8 13.3 13.9 22.2 23.6 25.0 26.4 27.8 29.1 30.5 31.9 33.3...
  • Page 92 For further questions on using the Omnitest® 5 system, contact the B. Braun representative in your area or visit us at www.bbraun.com. B. Braun Melsungen AG Carl-Braun-Str. 1 34212 Melsungen Germany www.bbraun.com 01864 2016/07/25 O5MMGPH...

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