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9.1 Specification of HGM-111 meter

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Measuring range: 20~600mg/dL

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Calibration: Plasma-calibration

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Measuring unit: mg/dL

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Measuring time: 5 seconds

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Sample type: Capillary whole blood samples drawn from the fingertips

or palm

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Blood Sample size: 1μL

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Operating temperature: (10 C~40 C)/(50 ºF ~104ºF)

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Relative operating humidity: Below 90%RH

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Memory capacity: Up to (512) test results (together with date, time

and unit) include average results for the last 7, 14 and 30 days

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Dimension: 93 mm x 52.3 mm x 25.3 mm (L×W×H)

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Weight: 70 g with batteries

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Power Supply: two CR2032 batteries

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Transmission: users can upload data to PC via transmission function.

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Storage temperature: -20 C~50 C (-4 F~122 F)

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Please protect the HGM-111 from impact

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Please do not disassemble the HGM-111

Chapter 9 Specifications

Samples

Mean glucose concentration measured CV

Sample 1

38.94 mg/dL

84.14 mg/dL

121.83mg/dL

178.24mg/dL
177.52mg/dL (9.85 mmol/L)

334.75mg/dL
177.52mg/dL (9.85 mmol/L)

43.98 mg/dL

136.62 mg/dL

338.71 mg/dL

Sample 2

4.83%

Sample 3

4.87%

Sample 4

4.16%

Sample 5

3.08%

Control solution 1

Control solution 2

4.90%

Control solution 3

4.46%

SD= 2.81 mg/dL

4.01 mg/dL

Within Run Precision:

Between Day Precision:

BLOOD GLUCOSE MONITORING SYSTEM-HGM-111

Содержание HGM-111

Страница 1: ...STANDARD AUTO BLOOD GLUCOSE MONITORING SYSTEM HGM 111 INSTRUCTION MANUAL ...

Страница 2: ...Before using this device to test blood glucose 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 s...

Страница 3: ...r 9 Specifications 1 1 Introduction 1 2 Intended use 1 3 List of Box Contents 2 1 Inserting replacing batteries 2 2 Setting up your HGM 111 meter 3 1 Preparation before glucose testing 3 2 Fingertip blood measurement 4 1 HGM 111 system testing 5 1 Reviewing result records 1 4 Product and Meter Display 3 3 Alternate Site Testing AST 6 1 Caring for the strips 6 2 Caring for the meter 2 3 Performing ...

Страница 4: ... 1 2 Intended Use Only the HGM STP1A blood glucose test strips are used with HGM 111 meter They are designed for users to measure the glucose concentration in fresh capillary whole blood obtained from fingertips and palm HGM 111 system is intended to be used by people with diabetes at home Warning HGM 111 system should not be used for screening diagnosis of diabetes or testing neonates Warning Do ...

Страница 5: ... Insert test strip here Middle Button Power On or Power Off Left Button Right Button Meter Display Cable Port Link with USB cable to download testing records to computers 1 Blood Glucose Meter HGM 111 2 Lancing Device 3 AST Cap 4 10 pcs Lancets 5 Carrying Case 6 Instruction Manual 7 Log Book 8 CR2032 x 2 3 BLOOD GLUCOSE MONITORING SYSTEM HGM 111 ...

Страница 6: ...mear sample on the strip B HGM STP1A Blood Glucose Test Strip Back Side Front Side Top Edge Apply blood sample here Inserting Bar Insert this test strip into the meter s strip slot with this face up Battery Compartment Strip Ejection Button Confirmation Window 4 BLOOD GLUCOSE MONITORING SYSTEM HGM 111 ...

Страница 7: ...C Function Display AC Before Meal PC After Meal CS Control Solution 5 BLOOD GLUCOSE MONITORING SYSTEM HGM 111 ...

Страница 8: ...that the battery power is too low to perform a test You have to replace the batteries to continue using the HGM 111 meter Time and date must be reset after replacing the batteries but the results records still remain How to replace HGM 111 s batteries 1 Turn HGM 111 to the back side and open the battery compartment 2 Take out the batteries and insert two CR2032 batteries with the sign facing up 3 ...

Страница 9: ...of old batteries according to your local environmental regulations a Open battery compartment b Take out and insert new batteries c Push back the battery compartment Push Push 7 BLOOD GLUCOSE MONITORING SYSTEM HGM 111 ...

Страница 10: ...d the date When you are using a new glucose meter or replace new batteries the display will be showing all symbols for one second and enter buzzer setting mode 1 Setting the buzzer Press left or right button shortly to select the on or off when the meter is in buzzer setting mode After selection please press the middle button shortly to set up and enter the year setting mode 8 BLOOD GLUCOSE MONITO...

Страница 11: ...e middle button to save your setting The display will now enter the month setting mode 3 Setting the month Once you enter the month setting mode the month field will flash 1 Click the right button to increase the month 2 Click the left button to decrease the month 3 Click the middle button to save your setting The display will now enter the day setting mode 9 BLOOD GLUCOSE MONITORING SYSTEM HGM 11...

Страница 12: ... save your setting The display will now enter the hour setting mode 5 Setting the Hour Once you enter the hour setting mode the hour field will flash 1 Click the right button to increase the hour 2 Click the left button to decrease the hour 3 Click the middle button to save your setting The display will now enter the minute setting mode B Setting the Time 10 BLOOD GLUCOSE MONITORING SYSTEM HGM 111...

Страница 13: ...e right button to increase the minute 2 Click the left button to decrease the minute 3 Click the middle button to save your setting C Complete the setup 7 After setting all the data the LCD will display your date and time setting and then turn off the power 11 BLOOD GLUCOSE MONITORING SYSTEM HGM 111 ...

Страница 14: ...M 111 meter will turn on All LCD segments will display for 1 second 2 Then the display will show the latest test result for 2 seconds B Apply sample 3 The strip symbol flashes alternatively with blood symbol as the following pictures and users can apply blood sample now 2 Sec 12 BLOOD GLUCOSE MONITORING SYSTEM HGM 111 ...

Страница 15: ...C Test blood glucose 4 After apply sample the test result will show on display after 5 seconds There is mg dL test unit showing on display 13 BLOOD GLUCOSE MONITORING SYSTEM HGM 111 ...

Страница 16: ...ture Chapter 3 Finger Blood Glucose Testing A Install the Lancet 1 Unscrew the adjustable tip of the lancing device Install a new lancet into the carrier correctly and make sure it is fully seated Then remove the protective cap and replace the adjustable tip 2 Adjust the puncture depth by the selection dial Normally at the 2nd level twist to a suitable number Smaller numbers are for shallower punc...

Страница 17: ...otective cap from the lancet d Replace the adjustable tip of lancing device and adjust the puncture depth a Unscrew the adjustable tip of the lancing device b Install the lancet 15 BLOOD GLUCOSE MONITORING SYSTEM HGM 111 ...

Страница 18: ... it clicks The lancing device is now ready for use C Preparation of test strip 4 Insert the test strip into the strip slot correctly and the HGM 111 meter will turn on All LCD segments will display for 1 second Insert the test strip Correctly Do not insert the strip from reverse side 16 BLOOD GLUCOSE MONITORING SYSTEM HGM 111 ...

Страница 19: ...ry thoroughly E Fingertip blood sampling 7 Please massage your fingertip gently to help you obtain blood We suggest that you puncture different areas each time Repeated punctures in the same area may cause soreness The blood sample requires only 1μL do not squeeze excessively at the puncture site 5 The display will show the latest test result and then strip symbol and drop symbol will appear 2 Sec...

Страница 20: ...d glucose test 9 Touch the blood drop to the tip of the confirmation window of test strip The test result will appear on the display after 5 seconds Warning Do not smear blood on the strip only touch blood to the tip of the strip Touch the blood drop on fingertip to the reaction zone ...

Страница 21: ...test strip and result will show on display The test result will automatically be stored in the meter memory 11 Press left or right button to enter AC PC setting mode users cannot enter AC PC setting mode while control solution testing mode the AC or PC symbol will be flashing If users donot want to set up AC or PC users can press the strip ejection button to remove the strip or press the middle bu...

Страница 22: ...e strip ejection button to remove the strip to avoid blood contamination Notice The meter will turn off automatically after removal of the test strip I Dispose of used strip and lancet properly Push After use press the lancet needle point into the protective cap Push forward the ejector to dispose 20 BLOOD GLUCOSE MONITORING SYSTEM HGM 111 ...

Страница 23: ...ollowing section before you try testing from other areas Caution 1 Talk to your healthcare professional about Alternate Site Testing 2 Do not change your treatment because of just one result 3 NEVER ignore symptoms of high or low blood glucose 4 If your blood glucose does not match how you are feeling perform a fingertip test to confirm your result If the fingertip result still does not match how ...

Страница 24: ...ing device firmly against a fleshy area on the alternative site Press the lancing device up and down in a slow pumping motion to assist the flow of blood 6 Trigger the lancing device will be keeping steady pressure on the puncture site Immediately lift the lancing device off of the site 7 Squeeze the puncture site with appropriate pressure slowly to get enough blood 8 Slightly touch the top of str...

Страница 25: ...e the bottle of the control solution before you use it Please replace new control solution if control solution deteriorates or coagulates Before running the test place the HGM 111 meter test strips and glucose control solution at room temperature for 30 minutes to allow them to reach the new temperature before use When to run the glucose control solution test The test strip vial is opened for long...

Страница 26: ...t measurement data 2 When the screen shows the drop blood symbol press and hold the middle button to enter control solution test mode After the symbol of the bottle appears the meter enters the glucose control solution test mode glucose control solution test mode Blood test mode 24 BLOOD GLUCOSE MONITORING SYSTEM HGM 111 ...

Страница 27: ...t 7 After 5 seconds the screen will display test result The meter will automatically turn off after the test strip is removed Discard the used test strip in accordance with local regulations Write the date you first open the bottle on the bottle label The control solution must be discarded after three months from the date the bottle was opened on the discard date or on the expired date on the bott...

Страница 28: ...the control solution test again Warning If the result continues to be outside of the expected range here are some points that have to be checked Did you follow all of the testing instructions Are the test strips or control solution past the expired date or discard date Is there a HGM 111 meter defect in materials or workmanship Repeat the control test with a new test strip If you still have any pr...

Страница 29: ...ssing left button until the earliest result Press the left button shortly at this time to show 30 days 14 days and 7 days average result 4 Press the right button shortly to review the next result and continue pressing right button until the last result Press the right button shortly at this time to show 7 days 14 days and 30 days average result 5 Users can press the middle button shortly when revi...

Страница 30: ...s after 90 days from the opening date Keep the strip bottle away from direct sunlight and heat and store between 4 C 30 C Do not refrigerate the test strip The strip bottle should be stored in a dry place at room temperature Do not transfer the test strips into other containers Always close the container tightly immediately after taking a test strip out Keep the test strip from getting dirty durin...

Страница 31: ...nals LO You may have a very low blood glucose level 20 mg dL 1 Do control solution test 2 Re do your glucose test 3 Contact your healthcare professionals Temperature Error You may have tested near the low or high end of the meter s operating temperature range 10 C 40 C 50 F 104 F Repeat the test after the meter has reached a temperature within the operating range Low battery warning The power is t...

Страница 32: ...200 test numbers Chapter 8 HGM 111 Performance Characteristics Precision This study shows the variability from strip to strip in sample tests The results are shown in the following table Slope y intercept mg dL Correlation factor R2 Test number n Test range mg dL 12 38 31 6 25 38 65 8 37 38 97 4 Within 5 mg dL Within 10 mg dL Within 15 mg dL 46 162 28 4 103 162 63 6 146 162 90 1 156 162 96 3 Withi...

Страница 33: ...70 g with batteries Power Supply two CR2032 batteries Transmission users can upload data to PC via transmission function Storage temperature 20 C 50 C 4 F 122 F Please protect the HGM 111 from impact Please do not disassemble the HGM 111 Chapter 9 Specifications Samples Mean glucose concentration measured CV Sample 1 38 94 mg dL 84 14 mg dL 121 83mg dL 178 24mg dL 177 52mg dL 9 85 mmol L 334 75mg ...

Страница 34: ...move the battery and dispose of the meter according to your local regulations CONSULT INSTRUCTIONS FOR USE IN VITRO DIAGNOSTIC MEDICAL DEVICE Council Directive 98 79 EEC on in vitro diagnostic medical devices KEEPAWAYFROMSUNLIGHT PAPERRECYCLE KEEPDRY MANUFACTURER DATE OF MANUFACTURE AUTHORISED REPRESENTIVE IN THE EUROPEAN COMMUNITY DO NOT USE IF PACKAGE IS DAMAGED For self testing TEMPERATURE LIMI...

Страница 35: ...iLance Medical Suzhou Inc No 68 Litanghe Road Xiangcheng Suzhou 215133 China Blood Glucose Meter Test Strip and Control Solution Deltronics Netherlands BV Zandsteen 15 2132 MZ Hoofddorp The Netherlands Emergo Europe Molenstraat 15 2513 BH The Hague The Netherlands TEL 31 0 70 345 8570 FAX 31 0 70 346 7299 33 BLOOD GLUCOSE MONITORING SYSTEM HGM 111 ...

Страница 36: ... Road 05 05 08 Alexandra Technopark Singapore 119967 www omron healthcare com sg DELBio INC 3F No 252 Shangying Road Guishan Industrial Zone Taoyuan County 33341 Taiwan DELTRONICS NETHERLANDS BV Zandsteen 15 2132 MZ Hoofddorp The Netherlands 5011556100 12 12 REV 00 ...

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