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CONSULT INSTRUCTIONS FOR USE

CAUTION

BATCH CODE

TEMPERATURE LIMITATION

IN VITRO DIAGNOSTIC MEDICAL

DEVICE

DO NOT REUSE

Council Directive 98/79/EEC

on in vitro diagnostic medical devices

SERIAL

USE BY

NUMBER

KEEP AWAY FROM SUNLIGHT

DO NOT USE IF PACKAGE IS DAMAGED

KEEP DRY

STERILIZED USING IRRADIATION

MANUFACTURER

AUTHORISED REPRESENTIVE IN THE

EUROPEAN COMMUNITY

For self-testing

0120

DELBio, INC.

3F, 252 Shangying Road, Guishan Industrial Zone,

Taoyuan County 33341, Taiwan

www.delbio.com.tw

Deltronics (Netherlands) BV

Zandsteen 15, 2132 MZ Hoofddorp, The Netherlands

PAPER RECYCLE

OMRON blood glucose monitoring system HEA-230.indd 27

2012/6/14 上午 11:14:56

Содержание HEA-230

Страница 1: ...Blood Glucose Monitoring System OMRON blood glucose monitoring system HEA 230 indd 2 2012 6 14 上午 11 14 48 ...

Страница 2: ...OMRON blood glucose monitoring system HEA 230 indd 3 2012 6 14 上午 11 14 48 ...

Страница 3: ...r 3 Glucose Testing 3 1 Preparation before glucose testing 3 2 Fingertip blood measurement Chapter 4 Glucose Control Solution Testing Optional 4 1 Control test Chapter 5 Memory Function 5 1 Reviewing past results Chapter 6 Instructions on Caring and Storing for Your Strips and Meter 6 1 Caring for the strip 6 2 Caring for the meter Chapter 7 Troubleshooting Chapter 8 HEA 230 Performance Characteri...

Страница 4: ...read all instructions thoroughly and practice the test Carry out all the quality control checks as directed 8 Use this instrument in a dry environment if synthetic materials are present synthetic clothing carpets etc it may cause damaging static discharges that may cause erroneous results 9 Do not use this instrument in close proximity to sources of strong electromagnetic radiation as these may in...

Страница 5: ...for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips Testing is done outside the body It is designed for self testing to monitor the effectiveness of diabetes control The device should not be used for screening or diagnosis of diabetes or for testing neonates Principle of the method Principle of the method By auto filled mechanism the volume ...

Страница 6: ...device 5 Carrying Case 6 Instruction Manual 7 Log Book 8 2 x AAA Batteries 1 3 Product and meter display A Meter appearance Caution The measurement unit either mg dL or mmol L is fixed in the meter according to the country demand You are not able to change the unit in the meter The unit exchange ratio is as the followings 1 mmol L 18 02 mg dL OMRON blood glucose monitoring system HEA 230 indd 4 20...

Страница 7: ...le here Inserting Bar I n s e r t t h i s t e s t s t r i p i n t o t h e meters strip port with this side facing up B Strip appearance C Function display OMRON blood glucose monitoring system HEA 230 indd 5 2012 6 14 上午 11 14 49 ...

Страница 8: ...fter powered on It represents the battery power is too low to perform a measurement You have to replace the batteries in order to continue using this meter Time and date is required to be reset after replacing the batteries however the past results is still recorded How to replace batteries for Meter 1 Turn meter to the back side and open the battery compartment 2 Replace two new AAA batteries and...

Страница 9: ...right button three times to display the date To enter the date setting mode press and hold down the left button until calendar sign flashes How to set up the date Setting year Once you entered the date setting mode the last two digits of the year will flash 1 Press the right button once to increase a year 2 Press the left button once to decrease a year 3 Then press and hold down the left button to...

Страница 10: ...on to save your month The display will now enter the date setting mode Setting date Once you enter the day setting mode the day field will flash 1 Press the right button once to increase a day 2 Press the left button once to decrease a day 3 Then press and hold down the left button to save your setting The display will now show your new setting OMRON blood glucose monitoring system HEA 230 indd 8 ...

Страница 11: ...button until time sign flashes How to set up the time Setting Hour Once you entered the time setting mode the hour field will flash The time display is by 12 hour format AM is before noon and PM is afternoon or by 24 hour format 1 Press the right button once to increase an hour 2 Press the left button once to decrease an hour 3 Then press and hold down the left button to save your setting The disp...

Страница 12: ...isplay will now show the time of your new setting 2 3 Performing a blood glucose measurement 1 Inserting a test strip After inserting the test strip the meter will turn on automatically and all icons on the display will appear for 1 second Then the display will show the most recent test result For first time use or after battery changing it will enter into setting mode directly OMRON blood glucose...

Страница 13: ... the test strip vial then wait for 5 seconds to enter next screen display 3 Applying blood After entering the code number apply blood sign will appear on display Gently touch the blood drop to the tip of the test strip within 2 minutes then glucose level will show on the display after sign flashing for 5 seconds If the warning sign appears please see chapter 8 OMRON blood glucose monitoring system...

Страница 14: ...country demand You are not able to change the unit in the meter The unit exchange ratio is as the followings 1 mmol L 18 02 mg dL Chapter 3 Glucose Testing 3 1 Preparation before glucose testing Please prepare materials you need as listed below and read this manual carefully to ensure the correct measuring process and results blood glucose meter model HEA 230 blood glucose test strip model HEA STP...

Страница 15: ...device A Install the lancet Check if you use a new lancet or not unscrew the tip of lancing device install the lancet into the lancet holder correctly and make sure it is fully seated then remove the protective cap Adjust the puncture depth by selection dial please twist case to suitable number The smaller number for the shallower puncture and the larger number for the deeper puncture OMRON blood ...

Страница 16: ...arm water Rinse and dry thoroughly D Fingertip blood sampling Please massage your finger tip gently and it will help you to obtain blood smoothly We suggest that you could puncture different area each time Repeated punctures in the same area may cause soreness The blood sample for OMRON blood glucose test strip model HEA STP30 is just need approximately 1μL Do not squeeze excessively at puncture a...

Страница 17: ...ld the lancing device firmly against the side o f your fingertip Press the release button gently squeeze your finger to assist the flow of blood Touch the blood drop to the tip of the reaction zone of test strip after the symbol of blood drop flashes on the meter display The test result will appear on display after the meter counts down from 5 to 1 5 seconds Touch the blood drop of fingertip to th...

Страница 18: ...test result will automatically be stored in the meter memory Please dispose of used test strip and lancet to a sealed container to avoid environment pollution Important Do not use single use test strip more than once It should not be used for testing arterial venous or neonatal blood It should be used for testing fresh capillary whole blood only It should not be used for plasma If red blood cell c...

Страница 19: ...ill like to perform control solution test or have any question please contact your local authorized distributor for more information Important Use only the OMRON glucose control solution HEA CTR30 with HEA 230 meter and HEA STP30 strips Mark the newly opened bottle of control solution with the date opened discard any unfinished control solution over three months after opening Store control solutio...

Страница 20: ... test mode In the glucose control solution testing mode the results are not recorded in historical memory Fingertip blood test mode Press the left button to enter glucose control solution test mode 2 Running the glucose control solution test Before running the glucose control solution test always check the expiration date DO NOT use control solutions if expired Before using the control solution ge...

Страница 21: ...range printed on your test strip vial do not use your meter until you solve the problem Repeat the control solution test again If the result continues to be outside of the expected range here are some things you can check Did you follow all of the testing instructions Are the test strips or control solution past the expired date or discard date Is HEA 230 meter defective in material or workmanship...

Страница 22: ...then all icons will appear on the display for 1 seconds After the sign flashes and the display will show second the most recent test result Then you can press left button to review previous test results In this mode time and date display alternately HEA 230 system is able to store up to 512 test results together with date and time OMRON blood glucose monitoring system HEA 230 indd 20 2012 6 14 上午 ...

Страница 23: ...s and hold down left key will display the most test recent result Press right button once to display result averaging sign How to check average Information Press and hold down the left button to enter result average mode then result averaging sign flashes Press left or right button to calculate the average result based on the test results stored for the past 7 14 or 28 days OMRON blood glucose mon...

Страница 24: ...play will return to the past 7 day average screen How to read average measurement Average information displays the current day selection for average how many test results being recorded and glucose unit When test result exceeds 99 records It will represent OMRON blood glucose monitoring system HEA 230 indd 22 2012 6 14 上午 11 14 55 ...

Страница 25: ... vial should be stored in a dry place Do not put the test strip into other containers Always close strip vial tightly after taking a test strip out Keep the test strip from getting dirty or polluted during the storage 6 2 Caring for the meter If the meter s surface gets dirty gently wipe it with a cloth slightly dampened or one with mild detergent For those medical staff you may use 10 bleach 70 a...

Страница 26: ...w blood glucose level 1 1 mmol L 20 mg dL Recheck your glucose level and contact your healthcare professionals Temperature symbol continuously flash You may have tested in an environment near the low or high end of the system s operating temperature range 10 40 50 104 Repeat the test after the meter have reached a temperature within the operating range Battery symbol continuously flash The power i...

Страница 27: ...g dL 0 0925 mmol L Correlation factor n 0 9827 Patient number n 240 Test range 40 443 mg dL 2 2 24 6 mmol L Number and of results within reference for values were 75 mg dL 4 2 mmol L Within 5 mg dL 0 3mmol L Within 10 mg dL 0 6mmol L Within 15 mg dL 0 8mmol L 26 40 65 34 40 85 39 40 97 5 Number and of results within reference for values were 75 mg dL 4 2 mmol L Within 5 Within 10 Within 15 Within ...

Страница 28: ... Relative operating humidity Below 90 RH Relative storage humidity Below 75 RH Memory capacity Up to 512 test results together with date time and unit include average results for the last 7 14 and 28 days Dimension 9 0 x 6 0 x 2 5 cm L W H Weight Approximately 90g with batteries Power supply Two 1 5V AAA batteries Recommend to store in room temperature environment Please do not store in high tempe...

Страница 29: ...LIGHT DO NOT USE IF PACKAGE IS DAMAGED KEEP DRY STERILIZED USING IRRADIATION MANUFACTURER AUTHORISED REPRESENTIVE IN THE EUROPEAN COMMUNITY For self testing EC 0120 DELBio INC 3F 252 Shangying Road Guishan Industrial Zone Taoyuan County 33341 Taiwan www delbio com tw Deltronics Netherlands BV Zandsteen 15 2132 MZ Hoofddorp The Netherlands PAPER RECYCLE OMRON blood glucose monitoring system HEA 230...

Страница 30: ...OMRON blood glucose monitoring system HEA 230 indd 28 2012 6 14 上午 11 14 56 ...

Страница 31: ...OMRON blood glucose monitoring system HEA 230 indd 29 2012 6 14 上午 11 14 56 ...

Страница 32: ...5011554500 12 06 REV 00 OMRON blood glucose monitoring system HEA 230 indd 30 2012 6 14 上午 11 14 56 ...

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