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Guidance and manufacturer’s declaration – electromagnetic immunity

This device is intended for use in the electromagnetic environment specified below. The customer or the user of this device should assure that it is used in such an environment.

Immunity test

IEC 60601 test level

Compliance level

Electromagnetic environment – guidance

Radiated RF

IEC 61000-4-3

3 V/m
80 MHz to 2,5 GHz

3 V/m

Portable and mobile RF communications equipment should be used no closer to any part of this device, including
cables, than the recommended separation distance calculated from the equation applicable to the frequency of the
transmitter.

Recommended separation distance

d = 1,2

d = 1,2

80 MHz to 800 MHz

d = 1,2

800 MHz to 2,5 GHz

where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer
and d is the recommended separation distance in metres (m).

Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey,

a should be less than the

compliance level in each frequency range.b

Interference may occur in the vicinity of equipment marked with the following symbol:

NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies.

NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.

a Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with

accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which this device is used exceeds the applicable

RF compliance level above, this device should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating this device.

b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.

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Содержание ET-201

Страница 1: ...stem 10 Setting Date and Time 10 Checking the Unit of Measurement 10 Installing Batteries 11 Using the Check Strip to Check the Meter 12 Control Check with Glucose Cholesterol Uric Acid Control Solution 13 When to Run a Control Check with Glucose Cholesterol Uric Acid Control Solution 13 Items You Need 13 Steps for Running a Glucose Control Check 14 Steps for Running a Cholesterol Control Check 16...

Страница 2: ...rol Test Results 29 Testing Your Blood Uric Acid Level 30 Understanding Your Blood Uric Acid Test Results 32 Using the Meter Memory 33 Reviewing Stored Glucose Test Results 33 Reviewing Stored Cholesterol Test Results 34 Reviewing Stored Uric Acid Test Results 35 Deleting the Stored Memory of Blood Glucose Cholesterol Uric Acid Test Results 35 Taking Care of Your Meter 36 Maintaining the Meter 36 ...

Страница 3: ... in 6 seconds for glucose 150 seconds for cholesterol and 6 seconds for uric acid The EasyTouch GCU System is suitable for diabetes hypercholesterolemia and hyperuricemia management at home or professional use The EasyTouch GCU Meter can only be used with EasyTouch II Blood Glucose Test Strips EasyTouch Blood Cholesterol Test Strips and EasyTouch II Blood Uric Acid Test Strips The use of any other...

Страница 4: ...0 mg dL 5 mg dL 10 mg dL Amiloride 20 mg dL X X Acetaminophen 8 mg dL 15 mg dL 2 mg dL L Dopa 20 mg dL 1 25 mg dL 20 mg dL Dopamine 20 mg dL 3 mg dL 5mg dL Methyl Dopa 4 mg dL 5 mg dL 0 3 mg dL Galactose 400 mg dL X X Uric Acid 10 5 mg dL X X Xylose 50 mg dL X X Bilirubin X 20 mg dL 40 mg dL Creatinine X 20 mg dL 30 mg dL Glibenclamide X 10 mg dL 10 mg dL Ketoprofen X X 300 mg dL Hematocrit 30 55 ...

Страница 5: ...atures between 14 C and 40 C 57 2 F and 104 F and between 20 and 85 relative humidity If you use the system outside the proposed conditions it can give false results Be sure to store the test strips between 4 C and 30 C 40 F and 86 F and avoid direct sunlight Be sure to follow your local regulations for proper disposal of used test strips and lancets Do not use this meter in a dry environment espe...

Страница 6: ...6 Items in the Package EasyTouch GCU Meter EasyTouch GCU User s Manual Puncturer lancing device Log Book Lancets Check Strip Pouch Two AAA Batteries EasyTouch GCU ...

Страница 7: ...code key Control Solution EasyTouch II Blood Glucose Test Strips EasyTouch Cholesterol Test Strips EasyTouch II Uric Acid Test Strips EasyTouch II Glucose Control Solution 3 ml EasyTouch Cholesterol Control Solution 1 ml EasyTouch II Uric Acid Control Solution 3 ml CHOL ...

Страница 8: ...ry Compartment Code Key Slot Battery Cover Unit Changing Switch To Switch between mg dL and mmol L μmol L Getting to Know the EasyTouch GCU Blood Glucose Cholesterol Uric Acid Multi Function Monitoring System ...

Страница 9: ... must fill the whole area with blood You may apply your blood on either side of the sample target area UA Contact bars lnsert this end to test strip slot on the meter Strip handle You may touch here Sample target area Target area You must fill the whole area with blood Test Strips 15 L µ CHOL Contact bars lnsert this end to test strip slot on the meter Strip handle You may touch here Sample target...

Страница 10: ...tomatically enter the setting mode after you install the batteries 2 Press S button to obtain the correct month 3 Press M button to confirm the above setting and shift to the day setting 4 Repeat the same steps to set the hour and minute 5 When you finish setting the meter will turn off automatically Checking the Unit of Measurement Before you get started EasyTouch GCU meter can measure your blood...

Страница 11: ...L Yes You should check this setting every time you put batteries into your meter Use a screwdriver to adjust the switch Installing Batteries NOTE Your meter comes with two AAA size batteries 1 5V 1 Slide battery cover off of the back of the meter 2 Insert two AAA batteries 1 5 V into the battery compartment 3 Slide battery cover back into place ...

Страница 12: ...t on the meter 2 The screen should display OK If X appears on the screen remove the check strip and reinsert it If X displays again stop all testing and call our customer support You need to use the check strip to check the meter when You use EasyTouch GCU monitoring system for the first time You drop the meter You think there is something wrong with the results you got and you want to check wheth...

Страница 13: ...l or uric acid measurement you got and you want to check whether meter and test strips are working correctly or not EasyTouch GCU Meter EasyTouch II Blood Glucose Control Solution EasyTouch Cholesterol Control Solution EasyTouch II Uric Acid Control Solution EasyTouch II Blood Glucose Test Strips EasyTouch Cholesterol Test Strips EasyTouch II Uric Acid Test Strips Glucose Cholesterol Uric Acid cod...

Страница 14: ...he blood symbol S CAUTION Always check the glucose code key number to make sure it matches the number labeled on the test strip vial when you run a glucose control test Otherwise you may get incorrect results Always write down the opening date of your glucose control solution vial and test strip vial Both of them are good for only 3 months after first opening or until the expiration date whichever...

Страница 15: ...rst drop of the solution and let the second drop touch the edge of the sample targeting area on the test strip The control solution will be drawn into the targeting zone automatically 5 You will hear a beep sound Close the cap of the control solution immediately The meter starts to count down from 6 and then shows your result on the screen 6 Check if the displayed glucose value falls within the ac...

Страница 16: ...l solution vial and test strip vial Both of them are good for only 2 months after first opening or until the expiration date whichever comes first The result will be stored in memory and appear just like a blood cholesterol result 1 Insert the cholesterol code key into the code key slot on the back of the meter 2 Take one strip from the vial Close the vial quickly 3 Insert the test strip into the ...

Страница 17: ...irst drop of the solution and let the second drop touch the edge of the sample targeting area on the test strip The control solution will be drawn into the targeting zone automatically 5 You will hear a beep sound Close the cap of the control solution immediately The meter starts to count down from 150 and then shows your result on the screen 6 Check if the displayed cholesterol value falls within...

Страница 18: ...omes first The result will be stored in memory and appear just like a blood uric acid result 1 Insert the uric acid code key into the code key slot on the back of the meter 2 Take one strip from the vial Close the vial quickly 3 Insert the test strip into the test strip slot on the meter The meter will first display the code number and then the blood symbol S Steps for Running a Uric Acid Control ...

Страница 19: ... Close the cap of the control solution immediately The meter starts to count down from 6 and then shows your result on the screen 6 Check if the displayed uric acid value falls within the acceptable range shown on the test strip vial 7 Remove the test strip from the meter and discard it How to Read the Label on the Test Strip Vial Example Code number from particular lot of strips LOT number appear...

Страница 20: ...ng items Are your glucose cholesterol uric acid test strips or control solutions expired Have you ever forgotten to close your glucose cholesterol uric acid test strip vials or control solution bottles Does the code in the meter match the code on the test strip vial Do you follow all the operation instruction correctly Repeat the control test with a new test strip following the steps exactly CAUTI...

Страница 21: ...ucose code key green color in the glucose test strips box Cholesterol code key blue color in the cholesterol test strips box Uric Acid code key orange color in the uric acid test strips box Puncturer Lancets Alcohol swab not included Log book Preparing the Puncturer Lancing Device NOTE To increase blood flow warm fingers using warm water to wash hands and let your arm hang down at your side ...

Страница 22: ...euse the lancets Never share your puncturer with others Use an alcohol pad to wipe off blood from puncturer s tip To avoid accidental injury do not leave a lancet in the puncturer Always remove the used lancet immediately after a test Structure of Puncturer and Lancet 2 3 4 1 Trigger Carrier Adjustable tip LANZO Lancet Protective cover Lancet Ejector Sliding Mechanism ...

Страница 23: ...otating the top portion of the adjustable tip until the setting number lines up to the arrow Settings are based on skin type Depth 1 2 for soft or thin skin Depth 3 for average skin Depth 4 5 for thick or calloused skin 5 Hold the tip of the puncturer with one hand and pull the sliding mechanism with the other hand When a click is felt the trigger rises up Release the sliding mechanism and it will...

Страница 24: ...he code number on the vial of test strips you use 2 Take one strip from the vial Close the vial quickly Caution The test strips can be damaged when they are not capped and stored properly 3 Insert the test strip into the test strip slot on the meter The meter will first display code number and then the blood symbol S 4 When the screen shows the blood symbol S clean your finger with an alcohol swab...

Страница 25: ...stores your result in its memory automatically NOTE How much blood should be applied Although only a small amount of blood is needed it is very important that you put enough blood on your test strip so that the entire reaction zone is filled This ensures that your meter can give accurate and reliable results Caution If you don t apply enough blood you might need to use a new test strip to do the t...

Страница 26: ...mal fasting blood glucose is 70 100 mg dL 3 9 5 6 mmol L The above range is just a reference and it may not apply for every person Consult your doctor for the appropriate range for you 12 Put the protective cover of the lancet back on the lancet Pull the sliding mechanism back and slide the lancet ejector forward to eject the lancet 13 Discard the used lancet in an appropriate container with a lid...

Страница 27: ...the code number on the vial of test strips you use 2 Take one strip from the vial Close the vial quickly Caution The test strips can be damaged when they are not capped and stored properly 3 Insert the test strip into the test strip slot on the meter The meter will first display code number and then the blood symbol S 4 When the screen shows blood symbol S clean your finger with alcohol swab Let i...

Страница 28: ...tores your result in its memory automatically NOTE How much blood should be applied Although only a small amount of blood is needed it is very important that you put enough blood on your test strip so that the entire reaction zone is filled This ensures that your meter can give accurate and reliable results Caution If you don t apply enough blood you might need to use a new test strip to do the te...

Страница 29: ... to eject the lancet 13 Discard the used lancet in an appropriate container with a lid 14 Screw the adjustable tip back on the puncturer CAUTION To avoid accidental injury do not leave used lancet in the puncturer Always remove the used lancet immediately after each test Understanding Your Blood Cholesterol Test Results Consult your doctor for the appropriate range for you Normal fasting blood cho...

Страница 30: ... Each test strip vial contains one code key Make sure the number on the code key matches the code number on the vial of test strips you use 2 Take one strip from the vial Close the vial quickly 3 Insert the test strip into the test strip slot on the meter The meter will first display code number then the blood symbol S 4 When the screen shows blood symbol S clean your finger with alcohol swab Let ...

Страница 31: ...tores your result in its memory automatically NOTE How much blood should be applied Although only a small amount of blood is needed it is very important that you put enough blood on your test strip so that the entire reaction zone is filled This ensures that your meter can give accurate and reliable results Caution If you don t apply enough blood you might need to use a new test strip to do the te...

Страница 32: ... in an appropriate container with a lid 14 Screw the adjustable tip back on the puncturer Understanding Your Blood Uric Acid Test Results The expected blood uric acid value is as following Male 3 7 2 mg dL 179 428 μmol L Female 2 6 mg dL 119 357 μmol L The above range is just a reference and it may not apply for every person Consult your doctor for the appropriate range for you ...

Страница 33: ... date are displayed in order from the most recent to the oldest with each press of the M button The meter will turn off automatically in 3 seconds when the symbol is displayed on the screen Using the Meter Memory Reviewing Stored Glucose Test Results EasyTouch GCU Meter can automatically store the most recent glucose cholesterol and uric acid test results You can review the test results in order f...

Страница 34: ...pressing the S button 4 No test can be performed when you are checking the stored results If you wish to perform a new test please turn off the meter first and restart the steps described in the section Blood Glucose Cholesterol Uric Acid Testing 5 To stop checking the results stop pressing the M button The meter will turn off automatically in 30 seconds or via pressing S button 6 No test can be p...

Страница 35: ...ish to perform a new test please turn off the meter first and restart the steps described in the section Blood Glucose Cholesterol Uric Acid Testing Reviewing Stored Uric Acid Test Results Deleting Stored Blood Glucose Cholesterol Uric Acid Test Results 1 When the newest blood glucose cholesterol uric acid test result is displayed press and hold S button for 3 seconds The newest glucose cholestero...

Страница 36: ...an alcohol pad to wipe the surface of the meter but do not wipe the test strip slot or code key slot Do not disassemble the meter If you have any questions please contact Customer Service or your healthcare provider When the symbol is displayed on the screen please replace batteries immediately 1 Slide battery cover off from the back of the meter 2 Remove old batteries and insert 2 new AAA size ba...

Страница 37: ...lot or the test strip slot DO NOT immerse the meter in liquid You can clean your meter with 70 isopropyl alcohol swab Troubleshooting Guide SYMBOL WHAT IT MEANS ACTION The battery power is low Replace the batteries LO flashes 5 times before the meter turns off automatically The batteries are dead Replace the batteries ...

Страница 38: ...cooler place about 14 C 40 C 57 2 F 104 F You may need to wait as long as 20 minutes for the meter to cool down before testing again Example Your blood glucose test result is over 240 mg dL Consider ketone testing Re check your blood glucose level Follow the instructions of your healthcare professional regarding ketone testing Your blood glucose test result is over 240 mg dL Consider ketone testin...

Страница 39: ...yed again call your doctor immediately CHOL Your blood cholesterol level is lower than 100 mg dL 2 6 mmol L Re check your blood cholesterol level If LO is displayed again call your doctor immediately Your blood uric acid level is higher than 20 mg dL 1190 μmol L Re check your blood uric acid level If HI is displayed again call your doctor immediately Your blood uric acid level is lower than 3 mg d...

Страница 40: ... the test with a new test strip If the symbol is displayed again contact customer service 1 Using a wrong code key or the code key is inserted improperly 2 New meter hasn t been code 1 Check the code key Be sure the code key is inserted into the code key slot completely 2 Insert the code key The code key is damaged Contact customer service ...

Страница 41: ...nds 6 seconds Memory Capacity 200 test results 50 test results 50 test results Operating Condition Temperature Humidity 14 40 C 57 2 104 F 85 Relative Humidity Meter Storage Condition Transportation Condition Temperature Humidity 10 60 C 14 140 F 95 Relative Humidity Sample Volume 0 8 μl 15 μl 0 8 μl Sample Type Finger capillary whole blood Hematocrits Range 30 55 EasyTouch GCU Multi Function Moni...

Страница 42: ...ement of EN 61010 1 EN 61010 2 101 EN 60601 1 2 EN 61326 ET 301 Glucose Cholesterol Uric Acid Power Supply 1 5V AAA x 2 Meter Dimension HxWxD mm 88 x 64 x 22 Display LCD Display 35 x 45 mm Weight 59 grams without Batteries Life of Battery More than 1000 Times Technology Used Electrode based Biosensor ...

Страница 43: ...essures moisture intrusion unauthorized repair disassembly and natural disasters If you have problems with the product please contact the local distributor or agent for further information For EU Customer Service 49 6894 581020 Bioptik Technology Inc is not responsible for any accidents or worsening illness resulting from buyers or users improper use of the device without the instructions of profe...

Страница 44: ...ruction for use Temperature limitation Keep away from sunlight Manufacturer Used by Caution consult accompanying documents Authorized representative in the European Community Batch code Catalogue number Serial number Control In vitro diagnostic device Sterilized using irradiation Keep dry ...

Страница 45: ...urposes Harmonic emissionsIEC 61000 3 2 Not applicable Voltage fluctuations flicker emissionsIEC 61000 3 3 Not applicable Guidance and manufacturer s declaration electromagnetic immunity This device is intended for use in the electromagnetic environment specified below The customer or the user of this device should assure that it is used in such an environment Immunity test IEC 60601test level Com...

Страница 46: ...lectromagnetic site survey a should be less than the compliance level in each frequency range b Interference may occur in the vicinity of equipment marked with the following symbol NOTE 1 At 80 MHz and 800 MHz the higher frequency range applies NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and pe...

Страница 47: ...ion distance according to frequency of transmitterm 150 kHz to 80 MHz d 1 2 80 MHz to 800 MHz d 1 2 800 MHz to 2 5 GHz d 2 3 0 01 0 12 0 12 0 23 0 1 0 38 0 38 0 73 1 1 2 1 2 2 3 10 3 8 3 8 7 3 100 12 12 23 For transmitters rated at a maximum output power not listed above the recommended separation distance d in metres m can be estimated using the equation applicable to the frequency of the transmi...

Страница 48: ...Road Xiangcheng Suzhou Jiangsu 215133 P R China Lancing Device lncluded in the package Manufacturer Global Medical Market Corp Address Room No 1112 Ace Tower 9th Bldg 345 30 Kasan Dong Kumchon Ku Seoul Korea GMMC S L C Jordi de S Jordi 13 6 23 46022 Valencia Spain EMERGO EUROPE Molenstraat 15 2513 BH The Hague The Netherlands ...

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