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Blood Glucose Meter
Model # ADF-B27/ADF-B27A

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Summary of Contents for RCP ADF-B27

  • Page 1 Blood Glucose Meter Model # ADF-B27/ADF-B27A...
  • Page 2: Table Of Contents

    Blood Glucose Meter TABLE OF CONTENTS INTRODUCTION ............... 4 NOTES ON SAFETY ............5 INSTALLING THE BATTERIES ..........7 Handling batteries properly ........7 QUICK START ..............8 INTRODUCTION ............... 9 Intended Use ............... 9 HOW IT WORKS ..............9 ALTERNATIVE SITE TESTING (AST) ........
  • Page 3 Blood Glucose Meter Fingertip Testing............21 Alternative Site Testing ..........21 Transfer blood to the test strip ........22 Reset your meter and lancing device ....23 UNDERSTANDING THE RESULTS ........24 CARE AND STORAGE ............ 25 CLEANING AND DISINFECTION ........25 SPECIFICATIONS ............
  • Page 4: Introduction

    Model # ADF-B27/ADF-B27A INSTRUCTION MANUAL INTRODUCTION This Blood Glucose Meter is provided to by Remote Care Partners (RCP), for use exclusively with the health monitoring program from your provider. Please read this manual carefully and keep it handy for future reference.
  • Page 5: Notes On Safety

    Use of this device is only for the intended use described in this manual. Only use AndesFit testing strips supplied by RCP. Do not allow the device to contact surfaces that are too hot to touch. Do not use the device where aerosol sprays are being used.
  • Page 6 Blood Glucose Meter Do not use the device if it is not working properly, or if it has been damaged. 10. Read the entire manual before using the product to test your blood glucose. 11. If this equipment does cause harmful interference to radio or television reception, which can be determined by turning the equipment off and on, the user is...
  • Page 7: Installing The Batteries

    Blood Glucose Meter INSTALLING THE BATTERIES Open the battery cover on the back of the meter. If replacing the batteries, remove the used batteries. Insert 2 new (AAA) batteries with correct +/- direction. Close the battery cover. Handling batteries properly As soon as old batteries run out, replace them with new batteries.
  • Page 8: Quick Start

    Blood Glucose Meter QUICK START Prepare: Wash your hands with soap and water. Dry thoroughly. Gather supplies: Lancing device, lancet, tissue (for blotting blood from your finger after the puncture). Prepare the lancing device: Unscrew the cap, push the lancet firmly into the device, remove the rounded end of the lancet by turning (save this piece), screw the cap back on, and adjust the puncture depth (usually 3).
  • Page 9: Introduction

    Blood Glucose Meter INTRODUCTION Intended Use • This meter is intended for self-testing by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. It should be used only for testing glucose (sugar) and only with fresh capillary whole blood samples taken from the finger and the alternative sites including the palm, the forearm.
  • Page 10: Alternative Site Testing (Ast)

    Blood Glucose Meter ALTERNATIVE SITE TESTING (AST) AST can be used only during steady-state blood glucose conditions described in the section of “About AST”. Important: There are limitations for using AST. Please consult your healthcare professional before you do AST. What is AST? Alternative site testing (AST) means that people use parts of...
  • Page 11: Do Not Use Ast If

    Blood Glucose Meter a meal, physical exercise, or any other event, take a blood sample from your finger only. Perform AST ONLY in the following instances: ▪ In a pre-meal or fasting state (more than 2 hours since the last meal). ▪...
  • Page 12: Contents Of Your Kit

    Blood Glucose Meter CONTENTS OF YOUR KIT ▪ A Meter ▪ Storage Bag ▪ Lancing Device ▪ Sterile lancet (Optional) NOTES: ▪ The Lancing Device can be used several times however the lancet should be changed after each use. ▪ Sterile lancets are not included in the standard kit V1.1 REMOTE CARE PARTNERS...
  • Page 13: Product Overview

    Blood Glucose Meter PRODUCT OVERVIEW The Blood Glucose Meter STRIP PORT  Where you insert the test strip. The meter will turn on automatically STRIP EJECTOR  Slide forward to eject the test strip after test LCD DISPLAY  It guides you through the test using symbols and simple messages “M”...
  • Page 14: The Test Strip

    Blood Glucose Meter The Test Strip Each strip can be used only once. The test strip consists of the following parts: V1.1 REMOTE CARE PARTNERS PAGE 14...
  • Page 15: The Lancing Device

    Blood Glucose Meter The Lancing Device If your lancing device is different from the once shown here, please refer to the manufacturer’s manual to ensure proper usage. To reduce the chance of infection: Never share a lancet or the lancing device. Always use a new sterile lancet.
  • Page 16: Setting Up The Meter And Deleting The Memory

    Blood Glucose Meter SETTING UP THE METER AND DELETING THE MEMORY Setting the date and time Setting the Year Press and Hold “S” button for 3 seconds, until the last two digits of the year will flash on the screen. Press “M” button until the correct year appears.
  • Page 17: Clearing The Memory

    Blood Glucose Meter Clearing the memory Press “S”. “dEL” will display along with a flashing “M”. Press “M” once to confirm that you want to clear the memory. If you want to cancel the process at this time, press “S”. To continue and clear the memory, press “M”...
  • Page 18: Taking A Measurement

    Blood Glucose Meter Do not allow other people to use your blood glucose meter. The meter is specifically assigned to you and you only. Allowing other people to use your meter can mislead your provider. TAKING A MEASUREMENT Wash your hands thoroughly with soap and warm water before taking a measurement Set Up the Lancing Device...
  • Page 19 Blood Glucose Meter 3. Gently turn and pull the needle cap to remove. Save the needle cap so that the lancet needle can be safely capped for disposal after the test. 4. Replace the device cap 5.. Adjust the puncture depts (usually 3) The lancing device is now ready to use.
  • Page 20: Insert A Test Strip Into The Meter

    Blood Glucose Meter Insert a test strip into the meter With clean dry hands remove a single test strip from its vial. Do not bend, cut, or modify the test strips in any way. Insert the test strip into the STRIP PORT at the top of the meter.
  • Page 21: Fingertip Testing

    Blood Glucose Meter Fingertip Testing Hold the landing device firmly against your fingertip. Press the release button on the side of the lancing device. You will hear a click, indicating that the puncture is complete. NOTES: • Choose a different spot each time you test.
  • Page 22: Transfer Blood To The Test Strip

    Blood Glucose Meter Transfer blood to the test strip Touch the blood sample to the absorbent hole at top of the test strip. As soon as enough blood has filled the confirmation window of the test strip, you will hear a beep letting you know the test has begun. A countdown of 5 seconds starts Your blood glucose level, along with the date and time, appears on the display.
  • Page 23: Reset Your Meter And Lancing Device

    Blood Glucose Meter Reset your meter and lancing device Eject the used test strip from the meter by sliding the strip ejector upward. Once the test strip is ejected, the meter will automatically turn off. Unscrew the cap of the lancing device. Remove the lancet by sliding the ejection button upward.
  • Page 24: Understanding The Results

    Blood Glucose Meter UNDERSTANDING THE RESULTS Reference value: Time of day People without diabetes Before breakfast <100 mg/dL (fasting) Two hours after meals <140 mg/dL Source: American Diabetes Association. Standards of Medical Care in Diabetes- 2012.Diabetes Care 2012,35(Suppl.1)S11-S63. Please work with your doctor to determine a target range that works best for you.
  • Page 25: Care And Storage

    Blood Glucose Meter CARE AND STORAGE • Handle the meter with care. Dropping or throwing the meter may cause damage to the device. • Do not expose the meter or test strips to extreme conditions, such as high humidity, heat, freezing cold, or dust. •...
  • Page 26: Specifications

    Blood Glucose Meter SPECIFICATIONS Model ADF-B27 / ADF-B27A* Machine size 90mm (L)×54mm (W)×13mm(H) Weight 73g (excluding batteries) Measuring Amperometric technology using method glucose oxidase Result range 20 mg/dL ~600 mg/dL (1.1 mmol/L ~33.3mmol/L) Glucose Units Either mg/dL or mmol/L*(ADF- B27A)
  • Page 27: Limitations Of Use

    Blood Glucose Meter LIMITATIONS OF USE • The meter is not intended for use on newborns. • The meter is not intended for use on artery blood, newborns. • The meter should be used with Andesfit test strips. (ADF-B27GTS) • The system can be used up to an altitude of 10744 feet.
  • Page 28 Blood Glucose Meter The following substances when used at greater than normal levels may produce inaccurate results by up to 10%: Compound Limitation Acetaminophen ≤8.0mg/dL Ascorbic Acid ≤5.0mg/dL Bilirubin ≤90mg/dL Cholesterol ≤500mg/dL Creatinine ≤5.0mg/dL Dopamine ≤2.0mg/dL EDTA ≤360mg/dL Galactose ≤900mg/dL Gentisic Acid ≤5.0mg/dL Glutathione...
  • Page 29 Blood Glucose Meter • Patients undergoing oxygen therapy may yield falsely lower results. • Not for use for patients in a hyperglycemic-hyperosmolar state, with or without ketosis. • Not for use on critically ill patients. • Not to be used for patients who are dehydrated, hypertensive, hypotensive, or in shock.
  • Page 30: Display Messages

    Blood Glucose Meter DISPLAY MESSAGES Blood glucose The message level is indicates very low lower than blood sugar. You 20mg/dL should seek (1.1mmol/L) immediate medical assistance. Blood glucose This indicates severely level is high blood sugar. You higher than should seek 600mg/dL immediate medical (33.3mmol/L)
  • Page 31 Blood Glucose Meter Problem with Re-test with a new the meter test strip. If the problem is still unsolved, please call the Customer Care Line for help. Problem with Re-test with a new the meter test strip. If the problem is still unsolved, please call the Customer Care Line for help.
  • Page 32: Troubleshooting

    Blood Glucose Meter TROUBLESHOOTING Problem Cause Solution Display remains Batteries may Install the blank after the be installed batteries test strip has improperly. correctly. been inserted into the Meter. Battery power is Replace with too low for use. new batteries. Too much time Reinsert the test has passed...
  • Page 33 Blood Glucose Meter Problem Cause Solution Test results are Not enough Redo test with inconsistent blood on the a new test strip test strip. and make sure that enough blood has been added. Test strip has Replace with a been new vial of Test damaged due Strips...
  • Page 34: Technical Specification

    Blood Glucose Meter TECHNICAL SPECIFICATION Measurement Precision Repeatability Mean (mg/dL) 40.3 82.0 SD (mg/dL) CV (%) Intermediate precision Mean 44.4 108.1 (mg/dL) SD (mg/dL) CV (%) System Accuracy For glucose concentration < 100 mg/dL Within±5 mg/dL Within±10 Within±15 mg/dL mg/dL 101/180(56.1%) 178/180(98.9%) 164/180(91.1%)
  • Page 35: For Glucose Concentrations<5.55 Mmol/L (<100 Mg/Dl)

    Blood Glucose Meter For glucose concentrations<5.55 mmol/L (<100 mg/dL) Puncture site Fingertip Palm Forearm ±15mg/dL 96.3% 96.3% 96.3% (±0.83mmol/L) For glucose concentrations≥5.55mmol/L (≥100 mg/dL) Puncture site Fingertip Palm Forearm Within±15% 99.3% 98.6% 98.6% ELECTRICAL AND SAFETY STANDARDS This meter complies with CISPR 11: Class B (Radiated Only).
  • Page 36: Symbols Index

    Blood Glucose Meter SYMBOLS INDEX Symbol Referent Symbol Referent Use by Date of manufacture Consult Batch code instructions for use In vitro diagnostic CAUTION medical device Keep away Catalog number from sunlight Keep dry Serial number Temperature Control limitation V1.1 REMOTE CARE PARTNERS PAGE 36...
  • Page 37: Contact Information And Notices

    Blood Glucose Meter CONTACT INFORMATION AND NOTICES Remote Care Partners 855-477-7000 www.remotecarepartners.com AndseFit LTD Unit 513 Lakeside 1, No. 8 Science Park West Ave Hong Kong Science Park Hong Kong FCC Compliance Statement This device complies with part 15 of the FCC Rules.
  • Page 38 Blood Glucose Meter FCC WARNING This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to Part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference in a residential installation.

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