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Within Run Precision:

Samples

Mean glucose concentration

measured CV

Sample 1

41.01 mg/dL

83.49 mg/dL

116.82mg/dL

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

341.61mg/dL
177.52mg/dL (9.85 mmol/L)

42.83 mg/dL

134.36 mg/dL

334.93 mg/dL

Sample 2

4.26%

Sample 3

4.85%

Sample 4

4.66%

Sample 5

4.05%

Between Day Precision:

Control solution 1
Control solution 2

4.20%

Control solution 3

3.44%

Chapter 8 Specifications

8.1 Specification of HGM-112 meter

◆

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

◆

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

◆

Relative operating humidity: Below 90%RH

◆

Memory capacity: one memory for the lastest memory

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Dimension: 63.2 mm x 40.6 mm x 18.0 mm (L×W×H)

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Weight: 25.5 g with battery

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Power Supply: one CR2032 battery

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

◆

Please protect the HGM-112 from impact

◆

Please do not disassemble the HGM-112

SD= 4.02 mg/dL

3.61 mg/dL

Precision:

This study shows the variability from strip to strip in sample tests. The

results are shown in the following table.

BLOOD GLUCOSE MONITORING SYSTEM-HGM-112

Содержание HGM-112

Страница 1: ...INSTRUCTION MANUAL BLOOD GLUCOSE MONITORING SYSTEM HGM 112 BASIC AUTO ...

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: ...pter 3 Finger Blood Glucose Testing 3 1 Preparation before glucose testing 3 2 Fingertip blood measurment 3 3 Alternate Site Testing AST Chapter 4 Glucose Control Solution Testing Optional Chapter 5 Caring for Your Strips and Meter Chapter 6 Troubleshooting Chapter 7 HGM 112 Performance Characteristics Chapter 8 Specifications 1 4 1 HGM 112 system testing 5 1 Caring for the strips 5 2 Caring for t...

Страница 4: ...blood glucose test strips are used with HGM 112 meter They are designed for users to measure the glucose concentration in fresh capillary whole blood obtained from fingertips and palm HGM 112 system is intended to be used by people with diabetes at home Warning Do not change the therapy according to HGM 112 meter test result without consulting healthcare professional If you have any question about...

Страница 5: ...Lancets 5 Carrying Case 6 Instruction Manual 7 Log Book 8 CR2032 x 1 A HGM 112 Blood Glucose Meter Display 1 4 Product and Meter Display Caution This meter will not display mmol L Strip Slot Insert test strip here Meter Display Battery Compartment BLOOD GLUCOSE MONITORING SYSTEM HGM 112 ...

Страница 6: ...mation window of the test strip Do not smear sample on the strip C Function Display Battery Glucose data Unit Strip Blood icon Top Edge Apply blood sample here Inserting Bar Insert this test strip into the meter s strip slot with this face up Confirmation Window BLOOD GLUCOSE MONITORING SYSTEM HGM 112 ...

Страница 7: ...s shown on display after powering on Thus the meter will shut down after 20 seconds when the symbol is shown on display after powering on It represents that the battery power is too low to perform a test You have to replace the battery to continue using the HGM 112 meter How to replace HGM 112 s battery 1 Turn HGM 112 to the back side and open the battery compartment 2 Take out the battery and ins...

Страница 8: ...erforming a blood glucose test A Inserting a test strip 1 Insert the test strip into strip slot correctly the HGM 112 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 6 c Push back the battery compartment BLOOD GLUCOSE MONITORING SYSTEM HGM 112 ...

Страница 9: ... below and read this instruction manual or test strip manual to ensure the correct measuring process and results HGM 112 Blood Glucose Meter HGM STP1A Blood Glucose Test Strip Antiseptic wipes or alcohol wipes Lancing Device Lancet 3 1 Preparation before glucose testing 2 Sec 3 The strip symbol flashes alternatively with blood symbol as the following pictures and users can apply blood sample now B...

Страница 10: ...epth by the selection dial Normally at the 2nd level twist to a suitable number Smaller numbers are for shallower punctures and larger numbers are for deeper puncture a Unscrew the adjustable tip of lancing device b Install the lancet c Twist off the protective cap from the lancet d Replace the adjustable tip of lancing device and adjust the puncture depth 8 Structure 2 1 3 4 Ejector Barrel Trigge...

Страница 11: ... clicks The lancing device is now ready for use Warning Sterile lancet is single use only cannot reuse C Preparation of test strip 4 Insert the test strip into the strip slot and the HGM 112 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 2 Sec BLOOD GLUCOSE MONITORING SYSTEM HGM 112 ...

Страница 12: ...The blood sample requires only 1μL do not squeeze excessively at the puncture site 8 Hold the lancing device firmly against the side of your fingertip Press the release button gently and squeeze your finger to assist the flow of blood F Blood glucose test 9 Touch the blood drop to the tip of the confirmation window of test strip Caution Do not smear blood on the strip only touch blood to the tip o...

Страница 13: ... during measurment Using a false test strip G Blood glucose value display 10 The blood glucose test will be completed in 5 seconds from the time the blood drops into the test strip The last test result will automatically be stored in the meter memory H Dispose of used strip and lancet properly Warning Please follow proper precautions in accordance with local regulation when disposing of all materi...

Страница 14: ...pproved site is not ideal usually when your blood glucose is rapidly changing Please read the following 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 pe...

Страница 15: ...ck 2 Insert a test strip into the meter in the correct direction The meter turns on 3 A test strip and flashing blood drop symbol appear on the display 4 Gently massage the alternative site palm that you would like to draw blood from 5 Clean your hands and the alternative site you will puncture Press the lancing device firmly against a fleshy area on the alternative site Press the lancing device u...

Страница 16: ...the control result is within the range on the test strip container the test strips and meter are working properly Important Use Only the OMRON glucose control solution with the HGM 112 meter and HGM STP1A strips Mark the newly opened bottle of control solution with the date opened discard any unused control solution which is over three months after opening Store the bottle at 4 o C 30 o C 39 o F 8...

Страница 17: ... 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 bottle label whichever comes first Do not use control solution that is past the expired or discard date When to run the glucose control solution test The test strip vial is opened for long time or you think the test str...

Страница 18: ...w all of the testing instructions Are the test strips or control solution past the expired date or discard date Is there a HGM 112 meter defect in materials or workmanship Repeat the control test with a new test strip If you still have any problem please contact your local authorized distributors for more information 3 Understanding Control Test Results 8 When the control result is within the rang...

Страница 19: ... 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 during storage 5 2 Caring for the meter If the meter s surface gets dirty gently wipe with a cloth slightly dampened or use a mild detergent For medical staff you may use a 10 b...

Страница 20: ...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 21: ...ults obtained by patients with those obtained using clinical analyzer The following results were obtained by 200 test numbers Number and of results within reference for values were 75 mg dL Number and of results within reference for values were 75 mg dL 76 166 45 8 121 166 72 9 153 166 92 2 162 166 97 6 Slope y intercept mg dL Correlation factor R2 Test number n Test range mg dL 0 3191 mg dL 0 971...

Страница 22: ...on Measuring unit mg dL Measuring time 5 seconds Sample type Capillary whole blood samples drawn from the fingertips or palm Blood Sample size 1μL Operating temperature 10 C 40 C 50 ºF 104ºF Relative operating humidity Below 90 RH Memory capacity one memory for the lastest memory Dimension 63 2 mm x 40 6 mm x 18 0 mm L W H Weight 25 5 g with battery Power Supply one CR2032 battery Storage temperat...

Страница 23: ...TRUCTIONS 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 TEMPERATURE LIMITATION STERILIZED USING IRRADIATION CAUTION BATCH CODE USE BY DO NOT REUSE SEPARATE COLLECTION FOR ELECTRI...

Страница 24: ... 2132 MZ Hoofddorp The Netherlands 0120 Lancing Device and Lancets SteriLance Medical Suzhou Inc No 68 Litanghe Road Xiangcheng Suzhou 215133 China Blood Glucose Meter Test Strip and Control Solution Emergo Europe Molenstraat 15 2513 BH The Hague The Netherlands TEL 31 0 70 345 8570 FAX 31 0 70 346 7299 0197 BLOOD GLUCOSE MONITORING SYSTEM HGM 112 ...

Страница 25: ... 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 5011556300 12 12 REV 00 ...

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