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4. FORA 6 Urine Acid Test Strip

ACS057

Accuracy

Results: Difference Plot Analysis

Number of subjects (N) = 160

TABLE 1 Ratio of samples (capillary whole blood) falling within different bias
ranges

Within ±5 %

Within ±10 %

Within ±15 %

Within ±20 %

64.1%

95.0%

100%

Measurement range: 3.3 ~ 10 mg/dL

Linear Regression: y = 1.0098x + 0.0095, R² = 0.9637, (n=320)

User performance

Results: Difference Plot Analysis

Number of subjects (N) = 160

TABLE 2 Ratio of samples (capillary whole blood) falling within different bias
ranges

Within ±5 %

Within ±10 %

Within ±15 %

Within ±20 %

68.1%

96.9%

100%

Measurement range: 3.3 ~ 10 mg/dL

Linear Regression: y = 1.0036x + 0.0499, R² = 0.9633, (n=160)

Precision

TABLE 3 Precision

Uric Acid Concentration (mg/dL)

LOW

MID

HIGH

Mean

5.1

10.1

15.0

SD.

o.205

0.258

0.438

CV%

4.05%

2.55%

2.92%

Содержание FORA 6 Connect

Страница 1: ...Version Rev 4 2 Release date 07 Nov 2019 Editor Dean Chiu ForaCare Suisse AG Blood Glucose and Multi Functional Monitoring System FAQs...

Страница 2: ...s 34 Q8 What kind of substance interferes FORA s BGM glucose reading in GOD and GDH FAD blood glucose test strips 38 Q9 How do you know if sufficient blood has been applied on the test strip 41 Q10 Ca...

Страница 3: ...different testing results 48 Q24 What is the meaning of universal tone in announcement of memory result 49 Ketone warning Q25 What is ketone warning 49 Changing the Setting Universal Tone Time Date a...

Страница 4: ...ood glucose management 53 Q35 What are the ways in which FORA BGM Meters transmit data and manage media 57 Q36 What are the support operation systems in FORA Healthcare system software 58 Q37 How is d...

Страница 5: ...Reaction Time 5 Seconds 5 Seconds 5 Seconds 5 Seconds Hematocrit Range 0 70 0 70 20 60 20 60 Measuring Range 10 600 mg dL 0 55 33 3 mmol L 10 600 mg dL 0 55 33 3 mmol L 20 600 mg dL 1 1 33 3 mmol L 20...

Страница 6: ...7 uL Reaction Time 7 Seconds 7 Seconds Hematocrit Range 20 60 35 60 Measuring Range 20 600 mg dL 1 1 33 3 mmol L 20 600 mg dL 1 1 33 3 mmol L Alternative Site Testing YES AST YES AST Applicable Sampl...

Страница 7: ...ds 5 Seconds Measuring Range BG 10 600 mg dL 0 55 33 3 mmol L HCT 0 70 Hb 0 23 8 g dL BG 10 600 mg dL 0 55 33 3 mmol L HCT 0 70 Hb 0 23 8 g dL Alternative Site Testing YES AST YES AST Applicable Sampl...

Страница 8: ...ydroxybutyrate Sample Size 0 8 uL 1 0 uL Reaction Time 10 Seconds 10 Seconds Measuring Range 0 1 8 0 mmol L 0 1 8 0 mmol L Hematocrit Range 10 70 10 70 Alternative Site Testing No AST No AST Applicabl...

Страница 9: ...ct GTel Enzyme Type Uric Acid Catalyst Sample Size 1 0 uL Reaction Time 15 Seconds Measuring Range 3 20mg dL 0 179 1 190mmol L Hematocrit Range 20 60 Alternative Site Testing No AST Applicable Sample...

Страница 10: ...Enzyme Type Cholesterol esterase Cholesterol oxidase Sample Size 3 0 uL Reaction Time 60 Seconds Measuring Range 100 400 mg dL 2 6 10 4 mmol L Hematocrit Range 20 60 Alternative Site Testing No AST Ap...

Страница 11: ...99 5 442 444 Table 3 Accuracy results for glucose concentrations between 40 mg dL 2 22 mmol L to 456 mg dL 25 3 mmol L Within 15 mg dL or 15 Within 0 83 mmol L or 15 99 3 596 600 Note According to the...

Страница 12: ...oncentration 100 mg dL 5 55 mmol L Tested sites Difference within 5mg dL Difference within 10mg dL Difference within 15mg dL Fingertip 59 117 50 4 102 117 87 2 115 117 98 3 Palm 49 118 41 5 92 118 78...

Страница 13: ...ble 3 Accuracy results for glucose concentrations between 40 mg dL 2 22 mmol L to 456 mg dL 25 3 mmol L Within 15 mg dL or 15 Within 0 83 mmol L or 15 99 3 596 600 Note According to the accuracy crite...

Страница 14: ...2 115 118 97 5 Upper arm 49 118 41 5 87 118 73 7 116 118 98 3 Precision In both intermediate precision and repeatability tests the standard deviation SD is within 5 mg dL 0 28 mmol L for each glucose...

Страница 15: ...LiquiColor reference method results Capillary samples n 480 ketone concentration mmol L Regression analysis Range 0 10 to 6 75 Mean 1 13 y 0 9997x 0 0153 R 0 9912 Venous samples n 480 ketone concentr...

Страница 16: ...dL Linear Regression y 1 0098x 0 0095 R 0 9637 n 320 User performance Results Difference Plot Analysis Number of subjects N 160 TABLE 2 Ratio of samples capillary whole blood falling within different...

Страница 17: ...777x 1 9945 R 0 9724 n 640 User performance Results Difference Plot Analysis Number of subjects N 160 TABLE 2 Ratio of samples capillary whole blood falling within different bias ranges Within 5 Withi...

Страница 18: ...ts for glucose concentrations between 40 3 mg dL 2 24mmol L to 547 0mg dL 30 39mmol L Within 15 mg dL or 15 Within 0 83 mmol L or 15 97 8 939 960 Note According to the accuracy criteria of EN ISO 1519...

Страница 19: ...L Tested sites Difference within 5mg dL Difference within 10mg dL Difference within 15mg dL Fingertip 55 0 61 111 88 3 98 111 97 3 108 111 Precision In both intermediate precision and repeatability t...

Страница 20: ...338 660 85 5 564 660 97 1 641 660 Table 3 Accuracy results for glucose concentrations between 40 3 mg dL 2 24mmol L to 547 0mg dL 30 39mmol L Within 15 mg dL or 15 Within 0 83 mmol L or 15 97 8 939 96...

Страница 21: ...the standard deviation SD is within 5 mg dL 0 28 mmol L for each glucose concentration 100 mg dL 5 55 mmol L and the coefficient of variation CV is less than 5 for each glucose concentration 100 mg dL...

Страница 22: ...ents by comparing whole blood OHB results with plasma results obtained using reference laboratory instruments Please see Table 1 Table 1 Accuracy Mean different plot 0 1 mmol L Slope 1 0693 Intercept...

Страница 23: ...23 672 95 4 641 672 Table 3 Accuracy results for glucose concentrations between 32 3mg dL 1 79mmol L to 544 0mg dL 30 22mmol L Within 15 mg dL or 15 Within 0 83 mmol L or 15 96 8 929 960 Note Accordin...

Страница 24: ...Difference distribution for glucose concentration 100 mg dL 5 55 mmol L Tested sites Difference within 5mg dL Difference within 10mg dL Difference within 15mg dL Fingertip 39 114 34 2 80 114 70 2 110...

Страница 25: ...concentrations between 32 4mg dL 1 80mmol L to 532 0mg dL 29 56mmol L Within 15 mg dL or 15 Within 0 83 mmol L or 15 97 5 936 960 Note According to the accuracy criteria of EN ISO 15197 2015 95 of all...

Страница 26: ...ed sites Difference within 5mg dL Difference within 10mg dL Difference within 15mg dL Fingertip 61 115 53 0 95 115 53 0 115 115 100 Palm 49 118 41 5 92 118 78 0 118 118 100 Forearm 43 118 36 4 84 118...

Страница 27: ...able 3 Accuracy results for glucose concentrations between 32 3mg dL 1 79mmol L to 544 0mg dL 30 22mmol L Within 15 mg dL or 15 Within 0 83 mmol L or 15 96 7 928 960 Note According to the accuracy cri...

Страница 28: ...oncentration 100 mg dL 5 55 mmol L Tested sites Difference within 5mg dL Difference within 10mg dL Difference within 15mg dL Fingertip 50 106 47 2 81 106 76 4 104 106 98 1 Palm 36 103 35 0 73 103 70 9...

Страница 29: ...3 Accuracy results for glucose concentrations between 37 6mg dL 2 09mmol L to 533 0mg dL 29 61mmol L Within 15 mg dL or 15 Within 0 83 mmol L or 15 97 2 933 960 Note According to the accuracy criteria...

Страница 30: ...18 98 3 Precision In both intermediate precision and repeatability tests the standard deviation SD is within 5 mg dL 0 28 mmol L for each glucose concentration 100 mg dL 5 55 mmol L and the coefficien...

Страница 31: ...ause erroneous results 12 Do NOT use this instrument in close proximity to sources of strong electromagnetic radiation as these may interfere with the correct operation 13 Proper maintenance as well a...

Страница 32: ...e healthcare professional before use 5 If your test results are lower or higher than usual and you do not have symptoms of illness first repeat the test If you have symptoms or continue to get results...

Страница 33: ...ane because the cabin pressure oxygen and temperature are within our tolerance range in any altitude However 3257 m 10742 ft is the upper altitude limit for FORA s glucose 3 in 1 Ketone testing in mou...

Страница 34: ...FORA s BGMs and test strips 1 FORA 6 Series Meter BG Strip ACS045 BG HCT HB 3 in 1 Strip ACS051 Ketone Strip ACS053 Uric Acid Strip ACS057 Total Cholesterol Strip ACS055 FORA 6 Plus GD81 FORA 6 Conne...

Страница 35: ...35 65 2 FORA Diamond Series Meter BG Strip ACS044 FORA Diamond PRIMA DM10 FORA Diamond VOICE DM20 FORA Diamond MINI DM30a b FORA Diamond GD50 GD50...

Страница 36: ...36 65 3 FORA ADVANCED Pro COMFORT Pro Series Meter BG Strip ACS047 BG HCT HB 3 in 1 Strip ACS050 Ketone Strip ACS052 FORA ADVANCED Pro GD40 g h FORA COMFORT Pro GD40 a b...

Страница 37: ...ries Meter BG Strip ACS042 BG Strip ACS041 BG Strip ACS043 FORA COMFORT advance G31 a b FORA COMFORT plus voice V30a FORA COMFORT plus G30a FORA COMFORT plus mini G71a FORA COMFORT basic G20 G20a FORA...

Страница 38: ...amine Limiting Concentration 2 5 mg dL Levo Dopa Limiting Concentration 2 1 mg dL Methyl Dopa Limiting Concentration 1 25 mg dL Tolazamide Limiting Concentration 20 mg dL Galactose Hemoglobin Hemolysi...

Страница 39: ...on 0 7 mg dL Methyl Dopa Limiting Concentration 0 625 mg dL Tolazamide Galactose Hemoglobin Hemolysis Method Lipemic Samples Triglycerides Limiting Concentration 3000mg dL Reduced Glutathione Limiting...

Страница 40: ...olazamide 12 5 mg dL 12 5 mg dL 12 5 mg dL Galactose 250 mg dL 250 mg dL 250 mg dL Hemoglobin Hemolysis Method 100 mg dL Lipemic Samples Triglycerides 3000 mg dL 3000 mg dL 3000 mg dL Reduced Glutathi...

Страница 41: ...n inserting the test strip Test results might be wrong if the contact bar is not fully inserted into the test slot Q10 Can I use ForaCare Suisse Test Strips with other brands of Meters No DO NOT use o...

Страница 42: ...2 We strongly recommend that you perform AST ONLY at the following times During a pre meal or fasting state more than 2 hours since the last meal Two hours or more after taking insulin Two hours or m...

Страница 43: ...st result Q13 How many testing sites can be used with FORA s test strips of BGM 1 Home use 1 Fingertips capillary palm forearm and upper arm blood are the alternative testing sites because of the AST...

Страница 44: ...s for the discrepancies could be 1 Test strip problems A Test strip expired B Test strip contaminated or damaged C Wrong code between test strip and meter D Not enough blood applied to the test strip...

Страница 45: ...ure and humidity based on the owner s manual in each meter and strip 6 The amount of red blood cells in your blood A If you are dehydrated or your red blood cell count is low anemia your test results...

Страница 46: ...hione antioxidant and uric acid for GDH strips e Hydration level for patients 1 Please obtain the blood samples again Do not excessively squeeze the pricked site We highly recommend wiping off the fir...

Страница 47: ...warning 100 to 30 2 From low battery warning to E b display on the screen turn off automatically 30 to 20 3 From E b display on the screen to no reaction when turn on 20 to 10 4 From no reaction when...

Страница 48: ...FORA Comfort series FORA Comfort plus G30a FORA Comfort advance G31 a b FORA Comfort plus mini G71a FORA Comport basic G20 G20a and FORA Comfort check G40 G40a Q23 What is the meaning of universal ton...

Страница 49: ...ersal tone in announcement of memory result Only the most recent result that was saved can be announced acoustically If you press MAIN to turn the meter on you will first hear the Long Beep which stan...

Страница 50: ...water Do NOT use organic solvents to clean the device Q28 When should I clean and disinfected my FORA BGM Clean your meter once a week or any time blood gets on the meter You should also clean the me...

Страница 51: ...calibrate the FORA GD40 series meters to make sure the strips and meters have the same code Procedure 1 Insert the code strip into the test slot of the device Wait for the device to display the code n...

Страница 52: ...e absorbent hole of the test strip to touch the drop Once the confirmation window is filled completely the device will begin counting down 5 Read and compare the result After counting down to 0 the te...

Страница 53: ...different control solution 3 Control solution may have expired 1 Choose the correct user mode and test again 2 Use ForaCare control solution only 3 Discard 90 days after opening 4 The results might b...

Страница 54: ...foracare tdlink mp 3 iFORA HM free download For iOS platform please go to https itunes apple com us app ifora hm id1169357723 For Android platform please visit https play google com store apps detail...

Страница 55: ...eleHealth System Manual https foracare suisse ag box com s el02o631cgzw79bdfpmy65fqv5jxpah5 FORA TeleHealth System Marketing Material https foracare suisse ag box com s hg38kqu21fzm0jo5wcvaqo3y7n1rblb...

Страница 56: ...56 65 4 Press mmol L to switch the unit 5 And then your measurement unit will be mmol L Of course you can use the same way to switch back to mg dL...

Страница 57: ...ftware TeleHealth System COMFORT plus G30a COMFORT plus voice V30a Diamond MINI DM30b Bluetooth Built in Bluetooth iFORA BG iFORA MP iFORA HM Healthcare Software TeleHealth System ADVANCED Pro GD40h B...

Страница 58: ...od Pressure Monitors Diamond Cuff BP Q37 How is data transmission done Please refer to the owner s manual of each meter s Transferring Data 1 Data Transmission Via Strip_Port_Comm Cable Micro USB USB...

Страница 59: ...tiated for data transmission The Bluetooth indicator flashes in blue 3 Make sure your BGM is already paired with your device with an iOS Android system or PC by following the instructions below 4 If y...

Страница 60: ...ny connection please find the instruction in meter manual for the pairing process The meter supports SSP Simple Secure Pairing as a result PIN is not required If host does not support SSP please use 0...

Страница 61: ...61 65 Lancet Device Q39 How to prepare the lancing device 1 Twist and pull off the cap of the lancing device b 2 Insert a lancet into the lancet holder and push down firmly until it is fully secured c...

Страница 62: ...he lock as shown in the picture until you hear the click When the lock is properly closed lock indicator is in the extreme right position e 5 Holding the cap select on the depth of penetration by turn...

Страница 63: ...s tip firmly against the lower side of your fingertip Press the release button to prick your finger then a click indicates that the puncture is complete h 8 Remove the device from the puncture site Af...

Страница 64: ...he used lancet Dispose of the lancet according to your local regulations k 11 For collecting blood samples from sites other than the fingertip use the clear cap Substitute the lancing device cap with...

Страница 65: ...potentially be biohazardous Discard it according to your local regulations Q41 How to clean the lancing devices 1 The lancet is disposable and is intended for single use only 2 The lancing device is r...

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