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IME-DC Dextra, User Manual

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IME-DC Dextra User Manual Download Page 43

43

TECHNICAL SPECIFICATIONS – TEST STRIPS

Dimensions:

30 × 6 mm

Material:

PET

Measurement method:

Electrochemical/dynamic

Enzyme:

GDH-FAD

Required blood volume:

0.7 µL

Sample type:

Fresh capillary blood, venous blood,  
arterial blood or neonatal blood

Calibration:

Plasma equivalent

Haematocrit range:

20 

‒

 70 %

Measurement temperature:

+10 °C to +40 °C

Storage temperature:

+4 °C to +32 °C

Relative humidity:

< 85 %

Shelf life:

18 months (from date of manufacture) 

After opening: 180 days

Suitable for clinical or private use!

Chemical composition:

 

■ 21.8 % Glucose dehydrogenase flavin adenine dinucleotide

 

■

41.6 % Potassium ferricyanide

 

■

36.6 % Non-reactive ingredients

Summary of Contents for Dextra

Page 1: ...TABLE OF CONTENTS NO CODING USER GUIDE BLOOD GLUCOSE MONITORING SYSTEM ...

Page 2: ......

Page 3: ...ate and time Test reminder SYMBOL DEFINITIONS 16 Insert test strip notification Blood sampling notification Measurement period Test result Measurement unit HI notification LO notification Memory display Test reminder Ketone notification ERROR DEFINITIONS AND RECTIFICATION 22 AVERAGE CALCULATION OF MEASUREMENTS 24 CONTROL SOLUTION 26 Using the control solution Testing with the control solution ...

Page 4: ... OF HIGH BLOOD SUGAR 38 POTENTIAL INFLUENCES ON THE MEASUREMENT READINGS 39 TECHNICAL SPECIFICATIONS BLOOD GLUCOSE METER 42 TECHNICAL SPECIFICATIONS TEST STRIPS 43 DATA TRANSFER 44 LIST OF ITEMS QUALITY STANDARDS 45 BATTERY REPLACEMENT 46 CLEANING AND MAINTENANCE 48 SAFETY AND DISPOSAL 49 Blood glucose meter Used test strips lancets and alcohol swabs Battery WARRANTY 50 EXPLANATION OF SYMBOLS 51 P...

Page 5: ...ement you should use for your therapy In order to obtain an accurate blood glucose measurement you must follow certain important guidelines Therefore please read this user guide carefully before using the device for the first time You will be amazed at how easy it is to take measurements Your blood glucose monitoring system contents 1 1 iDia Blood glucose meter and following accessories 10 iDia Bl...

Page 6: ...er test strips can lead to incorrect readings Close the storage container immediately after removing the test strip s Check the expiry dates of the test strips and control solution Use a new lancet for each blood sample Always store the measuring device or test strips according to the storage requirements and protect both from moisture direct sun light and other heat sources Keep the measuring dev...

Page 7: ...7 Test strip slot Main button Display DESCRIPTION OF SYSTEM COMPONENTS USER INTERFACE ...

Page 8: ... the blood glucose monitoring system is switched on will activate the display s blue background lighting This makes it possible to take and read measurements correctly even in low light conditions DESCRIPTION OF SYSTEM COMPONENTS LIGHT BUTTON AND DATA PORT ...

Page 9: ...9 Battery Battery Set button DESCRIPTION OF SYSTEM COMPONENTS BATTERY COMPARTMENT ...

Page 10: ...ontacts Insert the test strip into the test strip slot with the measurement contacts first Test area This area must be completely filled with the blood sample MEASUREMENT FIELD NOTE You can touch the measurement field of the iDia test strips freely with clean dry hands The test result will not be affected DESCRIPTION OF SYSTEM COMPONENTS ...

Page 11: ...s not the case you will need new batteries see page 46 Then set the current date and correct time To do this press the set button using a pen for example and then press the main button this changes the flashing value on the display NOTE Please be prepared for necessary battery changes by keeping two spare batteries with you Type CR 2032 CONFIGURATION ...

Page 12: ...trations 1 Set button pressed once The blood glucose meter switches itself on Year setting 2 Set button pressed second time Month setting 3 Set button pressed third time Day setting 4 Set button pressed fourth time Hour setting 5 Set button pressed fifth time Minute setting 1 2 3 4 5 CONFIGURATION ...

Page 13: ... times can be set see page 14 11 Set button pressed eleventh time The blood glucose meter switches itself off Finally place the battery cover on the device NOTE If you change settings using the set button and main button you will need to go through all of the settings until the blood glucose 11 6 7 8 9 10 CONFIGURATION ...

Page 14: ... this step Your iDia blood glucose monitoring system can issue an alarm tone five times a day to remind you to check your blood glucose level After pressing the set button six times see page 13 you can set five different times for test reminders The main button can be used to turn the test reminder function on 12 or off 13 13 12 ...

Page 15: ...button and then use the main button to set the desired hour 14 and minute 15 and confirm by pressing the set button again After setting the first test reminder it is possible to set four further test reminders NOTE You will be reminded to take your measurement by an alarm tone To complete the process press the main button for 1 second 15 14 ...

Page 16: ...st strip slot Correct insertion of the test strip will be confirmed by an audio signal BLOOD SAMPLING NOTIFICATION 17 Once the test strip has been inserted into the test strip slot the blood intake symbol appears in the display You now have three minutes to perform a blood glucose measurement If no blood sampling takes place within this time the iDia blood glucose meter will switch itself off auto...

Page 17: ...TIONS 18 MEASUREMENT PERIOD 18 Measurement begins once the test area of the test strip is sufficiently filled with blood and lasts only 7 seconds During the measurement an hourglass animation is visible on the display ...

Page 18: ...f the measurement the blood glucose value will be displayed and automatically saved together with the date and time 19 and 20 MEASUREMENT UNIT This will be displayed together with the measurement reading 21 and 22 19 20 21 22 SYMBOL DEFINITIONS ...

Page 19: ...will appear if the measured blood glucose value is below 10 mg dL or 0 6 mmol L 25 and 26 NOTE If you receive a HI or LO notification repeat the measurement procedure If the notification appears again perform a measure ment using the control solution see page 26 onwards or contact your specialist physician 23 24 25 26 SYMBOL DEFINITIONS ...

Page 20: ...user exceeds the memory capacity each addi tional measurement will automatically overwrite the oldest saved blood glucose value After switching on the blood glucose monitoring system and then pressing the main button the last blood glucose meter taken will be displayed with its corresponding date and time 27 and 28 By pressing the main button again other saved measurement results can be recalled 2...

Page 21: ...d glucose moni toring system is switched on see also page 15 KETONE NOTIFICATION 30 If the measured blood glucose value exceeds 300 mg dL or 16 7 mmol L the ketone notification will be automatically dis played which warns you of a potential ketoacidosis For more detailed information about ketoacidosis please consult with your specialist physician 29 30 ...

Page 22: ... display with an Err or EEE notification 31 Err battery symbol Not enough battery power Change the battery see page 46 onwards 32 Err thermometer symbol The ambient temperature is outside the acceptable temperature range The operating temperature must be between 10 C and 40 C 31 32 ...

Page 23: ...C customer service Service hotline 49 9281 85 01 6 0 34 Err test strip symbol Test strip malfunction Used test strip Not enough blood absorbed Not enough control solution absorbed The blood was absorbed before the blood sample symbol ap peared in the display Repeat the measurement with a new test strip ...

Page 24: ...y 35 see page 20 Simultaneously press the main button and light button and hold them for approximately 2 seconds The average value of the last 24 hours is displayed 36 Each time you press the main button again the average values for other periods the past 7 14 21 28 60 or 90 days will be displayed 37 42 To return to the memory display 43 press the main button and light button simultaneously and ho...

Page 25: ...25 AVERAGE CALCULATION OF MEASUREMENTS 35 36 37 38 39 40 41 42 43 ...

Page 26: ...se meter or the blood glucose test strips have been stored at an inappropriate temperature Following improper handling of the blood glucose meter In the event of questionable blood glucose readings NOTES The control solution must not be used after the expiry date When the control solution bottle is first opened the date must be written on the label The shelf life of the control solution is 90 days...

Page 27: ...ke a blood sample 45 Press the main button and hold it for approximately 2 seconds until the control solution symbol appears in the display You are now in the designated control solution measurement mode In this mode measurement results of the control solution are saved separately This prevents the average values of your personal blood glucose measurements being falsified by the control solution m...

Page 28: ...xample the lid of the test strip contain er at a distance of approximately 2 cm Then close the bottle Use a new drop of control solution for each measurement 47 Now place the application area of the test strip on the drop of control solution until the test area is completely filled An audio signal will confirm the start of the measurement 46 47 CONTROL SOLUTION ...

Page 29: ...nge see test strip container label The test result lies outside the control range If an error message is displayed during measurement or if the measured value is outside the target range as shown on the test strip container repeat the measurement If an error message ap pears again or if the measurement is again outside the target range please contact IME DC customer service Service hotline 49 9281...

Page 30: ...TABLE OF CONTENTS 30 LANCING DEVICE Spring clip Slot Activation button Lancing device cap Lancing device regulator can be adjusted individually ...

Page 31: ...TABLE OF CONTENTS 31 BLOOD LANCET Protective cap Lancet body Lancet ...

Page 32: ...vice cap 51 Insert the lancet into the slot 52 Twist off the lancet protection cap 53 Screw the lancing device cap back on 54 Set your personal puncture depth minimum 1 maximum 5 55 Load the lancing device by pulling the spring clip back 50 53 51 54 52 55 ...

Page 33: ...press the activation button 57 The blood drop obtained can be used for the measurement procedure 58 Unscrew the lancing device cap 59 Press the lancet into the protective cap 60 Slide the spring clip forward sharply to eject the lancet 61 Screw the lancing device cap back on 58 61 56 57 59 60 ...

Page 34: ...rement 64 Insert the test strip into the test strip slot on the iDia blood glucose meter The blood glucose meter system will switch itself on automatically If the temperature is within the permitted range the blood glucose meter will prompt you to touch the blood drop with the application area see page 10 Now use the lancing device to obtain a blood drop see 50 61 from page 32 onwards 62 63 64 ...

Page 35: ...the iDia test strip to the blood drop 65 The blood will be absorbed automatically An audio signal will confirm that measurement has started After 7 seconds the measurement reading will be displayed and saved automatically together with the date time and unit of measurement 66 and 67 66 67 65 ...

Page 36: ...h diabetes Empty stomach 100 mg dL 5 6 mmol L 126 mg dL 7 0 mmol L 2 hours after a meal 140 mg dL 7 8 mmol L 200 mg dL 11 1 mmol L 1 R Landgraf et al 2013 Praxisempfehlungen DDG DGIM Recommended prac tice German Diabetes Association German Association for Internal Medicine Diabetologie und Stoffwechsel Diabetology and metabolism Thieme Verlag ...

Page 37: ...for instructions on what actions to take Symptoms of low blood sugar hypoglycaemia Sweating Intense hunger High heart rate Tingling lips Slight difficulties with concentration Mood swings Trembling in some circumstances all over the body Distorted vision e g flickering Disorientation difficulty with targeted thinking or action Unconsciousness Cramps 2 G W Schmeisl Schulungsbuch für Diabetiker Trai...

Page 38: ...rination and thirst Weight loss Weak muscles leg cramps Itchiness Dizziness vomiting stomach ache Acetone odour like nail polish remover in exhaled air Unconsciousness NOTE If your blood glucose measurement value is less than 50 mg dL 2 8 mmol L or more than 250 mg dL 14 0 mmol L contact your specialist physician immediately ...

Page 39: ...ands before taking the blood glucose measurement You did not dry your hands before taking the blood glucose mea surement Excessively high blood pressure can result in inaccurately low measurement values Severely ill patients should not be tested with blood glucose mon itoring systems If inexplicable measurement results occur frequently please con tact your specialist physician Interferences Endoge...

Page 40: ... haematocrit values are less than 20 it is possible that an inaccurately high blood glucose value is displayed If haematocrit values are more than 70 it is possible that an inaccurately low blood glucose value is displayed When measuring EDTA treated blood samples with the iDia blood glucose meter the blood glucose values recorded may differ from those of an untreated blood sample Therefore the us...

Page 41: ... physician first Clinical institutions and professional caregivers Please dispose of used test strips according to your employer s instructions Please note that used test strips may represent an infectious hazard Private users Please dispose of used test strips according to local regulations To check that the blood glucose monitoring system is functioning correctly you have the option of carrying ...

Page 42: ... 40 C Storage temperature 20 C to 70 C Measurement memory 900 measurement values with time and date Blood glucose measurements and control solution measurements are stored separately Type Hand held device Automatic shutdown After three minutes if test strips are insert ed otherwise after one minute of inactivity Display LCD with blue background lighting Technology Patented dynamic measurement meth...

Page 43: ...rial blood or neonatal blood Calibration Plasma equivalent Haematocrit range 20 70 Measurement temperature 10 C to 40 C Storage temperature 4 C to 32 C Relative humidity 85 Shelf life 18 months from date of manufacture After opening 180 days Suitable for clinical or private use Chemical composition 21 8 Glucose dehydrogenase flavin adenine dinucleotide 41 6 Potassium ferricyanide 36 6 Non reactive...

Page 44: ...off and insert the USB cable jack into the data port on the device 68 Now start transfer of the data saved on the device 69 NOTE The basic requirement for data transfer is recognition of the blood glucose meter by the data transfer program If the iDia blood glucose meter is not yet listed there please contact IME DC customer service If data transfer is still not possible e ven when your computer d...

Page 45: ... EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices EN 60601 1 IEC 60601 1 Medical electrical equipment Part 1 General requirements for basic safety and essential performance EN 60601 1 2 IEC 60601 1 2 Medical electrical equipment Part 1 2 General requirements for basic safety and essential performance Collateral standard Electromagnetic dist...

Page 46: ... switches itself on the battery needs to be changed 70 71 Remove the battery cover 72 To remove the battery lightly press it towards the right until the battery is no longer held by the two plastic tabs on the left hand side Afterwards you can remove the battery by lifting it up left hand side first 70 71 72 ...

Page 47: ... cover NOTES After inserting the new batteries the device will switch to setup mode and the figures indicating the year will flash on the display Check the time and date settings and refresh these if necessary see page 12 onwards If no changes are necessary wait until the device shuts itself off automatically after approximately 1 minute Your saved measurements will not be lost after battery chang...

Page 48: ...toring system Do not use any strong cleaning agents for cleaning the device The outer surfaces of the blood glucose monitoring system may be disinfected using standard disinfectant wipes Avoid heavy contamination NOTE Handle your device with care CLEANING AND MAINTENANCE ...

Page 49: ... according to local regulations USED TEST STRIPS LANCETS AND ALCOHOL SWABS Used test strips lancets and alcohol swabs or similar materials may be infectious It is therefore important to treat used materials as infectious or biohazardous waste Please dispose of these materials according to local regulations BATTERY Prior to use check that the battery cover is closed Use only the recommended battery...

Page 50: ...glucose monitoring system for the intended purposes No guarantee can be made for improper use Please note The warranty does not take effect until the device has been activated Therefore after you take delivery of the blood glucose monitoring system fill out the warranty card in full and send it to IME DC GmbH Fuhrmannstrasse 11 95030 Hof Germany NOTE A warranty can only be honoured if the iDia blo...

Page 51: ...urer Date of manufacture Do not reuse Temperature limits Keep dry Keep away from sunlight Important read product documentation This product meets the requirements of the IVD Directive in accordance with 98 79 EC Class II device in accordance with Standard 60601 1 Applied Part Type B Dispose of device separately according to local regulations ...

Page 52: ...TABLE OF CONTENTS 52 PERSONAL NOTES ...

Page 53: ...TABLE OF CONTENTS 53 PERSONAL NOTES ...

Page 54: ...TABLE OF CONTENTS 54 PERSONAL NOTES ...

Page 55: ......

Page 56: ...XX0501XX00B Version 2018 05 IME DC GmbH International Medical Equipment Diabetes Care Fuhrmannstrasse 11 95030 Hof Germany Tel Fax E mail Website 49 9281 85 01 6 0 49 9281 85 01 6 100 info imedc de www imedc de ...

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