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This product fulfils the requirements of Directive
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In vitro diagnostic medical device

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Temperature limitation

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Use within 3 or 6 months after first opening

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Omnican® Lance soft: Do not use if the
protective cap is missing or damaged.

Содержание Omnitest 5

Страница 1: ...Omnitest 5 Blood Glucose Monitoring System ...

Страница 2: ...2 ...

Страница 3: ...abetes or for newborn testing neonates Omnitest 5 is intended for use outside the body in vitro diagnostic use only NOTE Prior to use read all of the instructions in this manual for the Omnitest 5 meter and the additional information in the test strip instructions for use Practice the correct and safe procedure for measuring blood glucose You should follow the recommendations of your diabetes care...

Страница 4: ... Lancing device Omnican Lance 16 Measuring blood glucose 18 Preparing for the measurement 20 Collecting blood with the lancing device 22 Measuring blood glucose 28 Marker function and display 37 Target level deviation indicator 42 Lighting the display 43 Stored readings 44 Displaying stored readings 46 Transferring readings 48 ...

Страница 5: ...Target level 56 Alarms 57 Exit settings 60 Functional check 62 Check strip 64 Control solution 66 Appendix 72 Error messages and troubleshooting 74 Maintaining your Omnitest 5 82 Changing batteries 84 Technical data and tips 86 Conversion table mg dL mmol L 90 ...

Страница 6: ...Nutzung 6 Overview ...

Страница 7: ...7 Contents Omnitest 5 Set Blood glucose meter Omnitest 5 Display symbols Test strips Omnitest 5 Lancing device Omnican Lance ...

Страница 8: ...g device with lancet 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 User manual and quick reference guide ...

Страница 9: ...r 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 be used inside and outside of the pouch The test strip vial is safely secured against falling out ...

Страница 10: ...10 Blood glucose meter Omnitest 5 Front 1 Illuminated test strip port 2 Eject button 3 Illuminated display 4 Up and Down button 5 ON OFF and selection button 1 2 3 4 4 5 ...

Страница 11: ...11 O v e r v i e w 6 7 9 8 Back 6 Product label 7 Battery cover 8 Strap holder 9 Data transfer port Micro USB port ...

Страница 12: ... was postprandial after meal Timer Reminder for follow up test is activated Test is associated with a special event e g perceived low blood sugar One or more alarms are active Up to 5 alarms can be set in the Omnitest 5 Indicator lit Battery voltage is low Change the batteries without delay Indicator flashing Battery voltage not sufficient to perform test Change the batteries without delay ...

Страница 13: ...ngs Up to 500 readings can be stored Display of average levels The average levels for 7 days 30 days and 90 days are displayed Basic settings for the Omnitest 5 and personal setting options for the user Time Date Preset target level optimal level Deviation from the target level Plus levels show a deviation upwards minus levels show a deviation downwards ...

Страница 14: ... accurate analysis of your blood glucose level the Omnitest 5 blood glucose meter must be used with the Omnitest 5 blood glucose test strips 1 Opening of the measuring chamber 2 Confirmation window 3 Meter contacting leads 4 Auto coding label Front Back 1 2 3 4 ...

Страница 15: ...tion date Avoid getting dirt food or water on the test strip All parts of the test strip could be touched with dry and clean fingers Do not bend cut or alter an Omnitest 5 test strip and coding on the backside Blood glucose tests may only be performed between 10 C and 40 C 50 F and 104 F and at a relative humidity of less than 90 NOTE Keep the test strip bottle away from children A child could cho...

Страница 16: ...ncing device 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 Release button Batch to read pull back the slider Protective cap Window Slide for loading Recessed grips Lancet ejector ...

Страница 17: ...es as well as the risk of infection Clean the Omnican Lance lancing device on a regular basis and whenever blood or other contamination is present after taking a sample to prevent from the transmission of infectious diseases Further handling instructions can be found starting of page 20 Additional cleaning instructions can be found on page 27 NOTE To avoid transmission of infectious diseases the l...

Страница 18: ...18 Measuring blood glucose ...

Страница 19: ...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 ...

Страница 20: ...n the finger tips The puncture site can alternatively be wiped with an alcohol soaked swab Please ensure that the site is completely dry before collecting the blood sample Taking the blood sample from clean finger tips prevents incorrect blood glucose measurements due to residues on skin surface of the fingertip E g contact with food especially fruits alcohol sweat and dirt before testing can dist...

Страница 21: ...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 NOTE Please read the additional information in the test strip instructions for use Your diabetes care professional will tell you your optimal blood glucose ranges Consult your physician before making any changes to your diabetes therapy ...

Страница 22: ...ican Lance device Collecting blood with the lancing 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 ...

Страница 23: ...ing 7 for deepest penetration depth Choose the penetration depth that is most suitable for your personal condition of skin 1 3 for soft or thin skin 4 for normal skin 5 7 for thick or calloused skin In order to adjust penetration depth hold the device with one hand at recessed grips and turn the dialable tip with number values with the other hand Turn it until the marking arrow points at the desir...

Страница 24: ...ush 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 NOTE The batch code for the device is printed under the slide for loading It becomes visible when the slide is moved back wards ...

Страница 25: ...t 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 Place the Omnican Lance device aside and wait seconds for a blood drop to form You can improve the flow of blood by keeping your hands warm lowering them to hip height and massaging the finger softly ...

Страница 26: ... the used lancet in a suitable container for sharps or for hazardous biological waste according to local guidelines 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 ...

Страница 27: ... 10 000 times of usage or not later than 5 years after first use 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 ...

Страница 28: ...al 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 The meter now switches on automatically Measuring blood glucose ...

Страница 29: ...st 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 It does not reflect the current battery status Notes on the low battery indicator can be found on page 84 ...

Страница 30: ...he codes match between the test strip vial and the display 4 NOTE If the code numbers do not match the blood glucose will not be measured accurately Make sure to compare the code number with the correct test strip vial Check that the coloured fields on the back of the test strip are undamaged Measuring blood glucose ...

Страница 31: ...3 minutes automatically if no test was performed with the test strip When this happens the test strip must be reinserted 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 ...

Страница 32: ...ur finger Your finger should remain still until the confirmation window is completely filled The minimal sample volume is 0 5 μL NOTE Do not squeeze the fingertip Do not attempt to apply a smeared blood sample The measuring chamber must be filled in one draw Reapplying can lead to incorrect readings Do not force your finger against the test strip the test strip must not be bent Measuring blood glu...

Страница 33: ... 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 The device may no longer be used if blood control solution or other fluids penetrate the test strip port beep ...

Страница 34: ...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 ...

Страница 35: ...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 If your display shows mmol L instead of mg dL contact our customer service The use of the wrong unit of measure can lead to a misinter pretation of the blood glucose levels and result in incorrect treatment ...

Страница 36: ...est 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 Measuring blood glucose ...

Страница 37: ...ollowing markers Marker function and display To select press the button The result is automatically saved with the marker displayed Test with control solution Test before meal preprandial Test after meal postprandial Timer activated Reminder for a follow up test General markings Special circumstances ...

Страница 38: ...reading as Test with control solution After testing choose the symbol with or The symbol for the control solution flashes Confirm your choice with the button The device switches off Marker function and display ...

Страница 39: ...bol 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 For a test after a meal postprandial choose the symbol with or and confirm your choice with the button Test before a meal preprandial Test after a meal postprandial ...

Страница 40: ...ymbol with or 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 or to change it in 15 minute intervals Press the button again briefly to start the timer The device switches off Marker function and display ...

Страница 41: ...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 or The symbol for general marking flashes Confirm your choice with the button The device switches off ...

Страница 42: ...NOTE To display the target level and the deviation from the target level the target level must be defined and activated in the Omnitest 5 see page 56 Enter the target level only in consultation with your physician or your diabetes educator Defined target level Deviation of the current measured level from the target level Target level deviation indicator ...

Страница 43: ...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 After 3 minutes of inactivity the device shuts off entirely To switch it on again remove the unused test strip and re insert it Lighting the display ...

Страница 44: ...44 Stored readings ...

Страница 45: ...45 Contents Displaying stored readings Transferring readings ...

Страница 46: ...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 ...

Страница 47: ...e 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 Average level for 90 days In the example shown within the past 7 days 7 d 35 tests 35 n performed and gives the average blood glucose level of 108 mg dL ...

Страница 48: ...ded to be able to use this function The cable can also be purchased as an accessory The device cannot be charged via the cable Directions for changing the battery can be found on page 84 When connected to your PC the Omnitest 5 display shows PC Your data remains stored on the Omnitest 5 NOTE Due to the risk of electric shock blood glucose testing must not be performed when the device is connected ...

Страница 49: ...r 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 An overview of compatible electronic diaries can be found at www bbraun com diabetes datamanagement ...

Страница 50: ...50 Settings ...

Страница 51: ...51 Contents Time and date Acoustic signal Timer Target level Alarms Exit settings ...

Страница 52: ...mbol 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 Use the button to switch between the setting options After changing the batteries the device settings are also called up automatically ...

Страница 53: ...S e t t i n g s 53 Time and date Press the button to set the hours minutes year month and day one after another With the buttons or you can change the flashing value Time and date ...

Страница 54: ...54 Acoustic signal Acoustic signals bEEP are activated by default on the Omnitest 5 Press the button or to change the status from On to OFF Confirm your choice with the button Acoustic signal ...

Страница 55: ...minder 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 or to change it in 15 minute intervals Press the button to save the alarm time for the timer Timer ...

Страница 56: ... 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 and to increase or reduce it Afterwards press the button to confirm the target level Target level ...

Страница 57: ...activate all alarms in the Omnitest 5 without deleting them Alternate with the buttons or between On and OFF and confirm your choice with the button If an alarm time is set but the alarm sound is switched off before a test the symbol OFF appears Alarms ...

Страница 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 ...

Страница 59: ...use the buttons and 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 When performing a blood glucose test the alarm does not work The volume of the alarm is designed to remind you of the next blood glucose measurement but not to wake you from a deep sleep ...

Страница 60: ...ter 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 ...

Страница 61: ...S e t t i n g s 61 ...

Страница 62: ...62 Functional check ...

Страница 63: ...63 Contents Check strip Control solution ...

Страница 64: ...64 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 ...

Страница 65: ...e continues to be displayed the meter may not be used for measuring blood glucose levels Contact your local representative for warranty services It is recommended to perform this test before the first use and after any a malfunction is suspected Meter is in proper order and switches off again Meter is defective Er 1 is displayed ...

Страница 66: ...e 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 If your blood glucose readings do not match your symptoms or if you suspect that the readings are not accurate If the meter was dropped For quality control in professional applications For training purposes and when learning...

Страница 67: ...tion 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 The meter switches on automatically ...

Страница 68: ...d 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 Guide the tip of the test strip towards the drop until it is drawn up by the test strip Control solution ...

Страница 69: ... 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 The result should fall within the range Repeat the test if the level displayed falls outside the range 4 ...

Страница 70: ...rformed a test with control solution you can now use the button or to mark the measured level with the symbol and confirm it Control solution NOTE Control solution labelled results are not included in the calculation of average levels ...

Страница 71: ...olution was not shaken Expired or contaminated control solution Control solution too warm or too cold First drop of control solution was not discarded or the tip of the container was not wiped clean Meter malfunction Damaged test strip Do not use the system to test your blood glucose until you get a control solution test result that falls within the specified range ...

Страница 72: ...Nutzung 72 Appendix ...

Страница 73: ...73 Contents Error messages and troubleshooting Maintaining your Omnitest 5 Changing batteries Technical data and tips Conversion table mg dL mmol L ...

Страница 74: ...ncorrect 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 There is a problem with the test strip The blood sample or control solution was applied before the symbol was shown on the display ...

Страница 75: ...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 The test strip is damaged Repeat the test with a new test strip Repeat the test with a new test strip Apply blood or control solution only after the symbol has been shown on the display ...

Страница 76: ...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 ...

Страница 77: ...eter 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 If the display alternates displaying Sun and Er6 avoid direct sunlight entering the test strip port and repeat the test The memory for the measurement results is empty until you have performed the first blood glucose test ...

Страница 78: ...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 ...

Страница 79: ...mes If the Hi high message persists please consult a physician promptly for assistance 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 Lo low message persists consult a physician promptly for assistance Change the batteries immediately Change the batteries immediately ...

Страница 80: ...smeared or could not be taken in one draw from the test strip The meter does not turn on The battery voltage is not adequate or there is a problem with the meter After applying the sample the test does not start The sample volume is not adequate or there is a problem with the test strips or the meter The result is doubtful There is a potential problem with the test strips The meter code and the co...

Страница 81: ...an puncture site Repeat the test with a sufficiently large fresh blood sample Change the batteries If the problem persists contact your retailer or B Braun representative in your area Apply a sufficient sample volume to the new test strip and repeat the test 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 ...

Страница 82: ... alcohol soaked swab can also be used to clean the external surfaces of the meter NOTE DO NOT use chemical solvents such as benzene or acetone because these may corrode the surface of the Omnitest 5 and damage it DO NOT apply pure alcohol directly to the meter for cleaning Instead use a tissue that has been moistened with a small amount of alcohol Allow the meter to dry completely after cleaning i...

Страница 83: ...e measurement function After testing store the Omnitest 5 components in its case in a cool dry place out of the reach of children Do not refrigerate Keep out of direct sunlight Detailed storage instructions for the Omnites 5 test strips can be found in the Omnitest 5 test strips instructions for use Discard used objects materials in accordance with local guidelines for contaminated materials ...

Страница 84: ...he 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 Open the battery cover on the back of the unit and insert two new batteries Ensure that the batteries are inserted in the right direction imprinted plus sign to the top ...

Страница 85: ... settings SEt Correct the time setting and date from there Further information on device settings can be found starting on page 52 NOTE Without correctly setting the date the correct values for the average blood glucose level and the results in the memory will not be displayed correctly It is strongly recommended to set the meter before use and to check the time after inser ting a new battery A bl...

Страница 86: ...ng accessories regularly System limitations For more information on system limitations or factors which could impact test results please read the Omnitest 5 test strips instructions for use The Omnitest 5 blood glucose monitoring system complies with EN ISO 15197 requirements Replace the blood glucose meter with a new device after a maximum of 5000 tests or at the latest 5 years after the first us...

Страница 87: ...hich are calibrated against a whole blood method may have different results in comparison to the Omnitest 5 results The laboratory system used to calibrate the Omnitest 5 system is YSI 2300 STAT plus which is equipped with a glucose oxidase system Instructions for disposal of defective meters Remove the batteries and send these for recycling according to local provisions Used meters can be soiled ...

Страница 88: ...e and additional data Operating temperature between 10 C and 40 C 50 F and 104 F Operating humidity 10 90 Sample type Fresh capillary or venous whole blood Sample volume 0 5 µL Screen type Backlit LCD Dimensions L x W x H 78 mm x 43 mm x 16 mm Weight incl batteries 45 g Power supply Two 3V lithium batteries CR2032 Battery life min 1 000 tests ...

Страница 89: ...edical 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 Device could be contaminated with infectious material after use Responsible manufacturer Omnican Lance soft Do not use if the protective cap is missing or damaged ...

Страница 90: ...mg dL 10 15 20 25 30 35 40 45 mmol L 0 6 0 8 1 1 1 4 1 7 1 9 2 2 2 5 mg dL 95 100 110 120 130 140 150 160 mmol L 5 3 5 6 6 1 6 7 7 2 7 8 8 3 8 9 mg dL 260 270 280 290 300 325 350 375 mmol L 14 4 15 0 15 5 16 1 16 7 18 0 19 4 20 8 Conversion table mg dL mmol L ...

Страница 91: ...3 9 4 2 4 4 4 7 5 0 170 180 190 200 210 220 230 240 250 9 4 10 0 10 5 11 1 11 7 12 2 12 8 13 3 13 9 400 425 450 475 500 525 550 575 600 22 2 23 6 25 0 26 4 27 8 29 1 30 5 31 9 33 3 A P P E N D I X Conversion factor 1 mg dL 0 0555 mmol L resp 1 mmol L 18 018 mg dL ...

Страница 92: ...5 O5MMGPH 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 ...

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