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Acon Vivid Pal User Manual

Blood glucose monitoring system
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Summary of Contents for Acon Vivid Pal

  • Page 3: Blood Glucose Monitoring System

    (CGMs) nor for use in insulin dose calculations. ® On Call Vivid Pal Blood Glucose Monitoring System is for single patient use only. Do not share with others. ® To ensure accurate results from your On Call...
  • Page 4 Not for use on critically ill patients, patients in shock, dehydrated patients or hyperosmolar patients. By following the instructions outlined in this User's Manual, you will be able to ® use your On Call Vivid Pal Blood Glucose Monitoring System to monitor your blood glucose and better manage your diabetes.

  • Page 5: Table Of Contents

    Table of Contents Getting Started ..................... 1 Component Descriptions ..............2 ® On Call Vivid Pal Blood Glucose Meter ..........4 Meter Display ..................6 ® On Call Vivid Blood Glucose Test Strips ..........8 ® On Call Vivid Glucose Control Solution ..........11 Installing the Battery ..................13...

  • Page 6: Getting Started

    Vivid Pal Blood Glucose Monitoring System. Depending on ® the On Call Vivid Pal product you purchased, you may need to buy some accessories separately (please contact Customer Service at 1-800-838-9502 for purchasing). Please check the list of contents on the outer box for details on which components are included with your purchase.

  • Page 7: Component Descriptions

    Component Descriptions ® On Call Vivid Pal Blood Glucose Meter: Reads the test strips and displays the blood glucose level. ® On Call Vivid Blood Glucose Test Strips: Equipped with a chemical reagent system. They measure glucose concentration in blood when inserted into the meter.
  • Page 8 Note: Important Safety Instructions 1. The meter and lancing device are for single patient use. Do not share them with anyone! 2. All parts of the kit are considered biohazardous. They can potentially transmit infectious diseases, even after you have performed cleaning and disinfection.

  • Page 9: On Call ® Vivid Pal Blood Glucose Meter

    ® On Call Vivid Pal Blood Glucose Meter The meter reads the test strips and displays the blood glucose concentration. Use these diagrams to familiarize yourself with all the parts of your meter. Strip Port <▲> Button <OK> Button <▼> Button...
  • Page 10 Liquid Crystal Display (LCD): Shows your test results and helps you through the testing process. <▲> Button: Recalls previous test results from the meter memory, selects meter settings and performs other menu selection functions. <▼> Button: Recalls previous test results from the meter memory, selects meter settings and performs other menu selection functions.

  • Page 11: Meter Display

    Meter Display Month Day Hour Minutes Test Result Area Memory Test Remind Symbol Before Meal Symbol Measurement Unit After Meal Symbo Pound Sign (#) Battery Symbol Control Solution Symbol Blood Drop /Strip Symbol Battery Symbol: Warns you when you should replace the battery. Blood Drop / Strip Symbol: Wait for the Blood Drop / Strip Symbol to appear before applying the sample.
  • Page 12 Meter Use and Precautions • Wait for the Blood Drop / Strip Symbol to appear before applying the sample. • The meter is preset to display blood glucose concentration in either millimoles per liter (mmol/L) or milligrams per deciliter (mg/dL). This depends on your country’s standard unit of measurement.

  • Page 13: On Call ® Vivid Blood Glucose Test Strips

    The On Call Vivid Blood Glucose Test Strips are thin strips. The strips have a ® chemical reagent system. They work with the On Call Vivid Pal Blood Glucose Meter to measure the glucose concentration in whole blood. After the strip is inserted into the meter, blood is applied to the sample tip of the test strip.
  • Page 14 Hold the blood drop to the sample tip of the test strip until the check window is completely full and until the meter begins to count down. If you applied blood but do not see the countdown start, you may reapply a second drop of blood within 3 seconds.
  • Page 15 Special Instructions for Test Strips in the Vial • Test strips must be stored in the original vial with the cap tightly closed; this keeps them in good working condition. • Do not transfer test strips to a new vial or any other container. •...

  • Page 16: On Call ® Vivid Glucose Control Solution

    It is used to confirm that ® your On Call Vivid Pal Blood Glucose Meter and test strips are working together properly. It also confirms that you are performing the test correctly. It is important to run a quality control test regularly to make sure you are getting correct results.
  • Page 17 Storage and Handling Please review the following storage and handling instructions: • Store the control solution at 36-86°F (2-30°C). • Do not refrigerate or freeze. • If the control solution is cold, do not use until it has warmed to room temperature.

  • Page 18: Installing The Battery

    Installing the Battery The battery may not be preinstalled in the meter. The meter requires one CR 2032 3.0 V coin cell batteries. Please find the battery in your carrying case and install it according to the following steps: 1. Turn over the meter and slide the battery cover off the top of the meter. 2.

  • Page 19: Meter Setup Before Testing

    Meter Setup Before Testing Before using your meter for the first time, you will need to adjust the settings that are listed in detail below. 1. Meter Setup Mode: Press the <OK> button for 2 seconds to enter the meter setup mode. The meter will automatically enter the setup mode when turned on for the first time.
  • Page 20 4. Time: The hour will appear at the top of the display. Press the <▲> or <▼> button to change to the correct hour. Press the <OK> button to save your choice and set the minutes. Press the <▲> or <▼> button to change to the correct minute.
  • Page 21 a warning when an error has occurred. Please check the error number on the display to confirm what kind of error has occurred. Press the <▲> or <▼> button to turn the meter beep “On” or “Off”. Press the <OK> button to confirm your selection. 7.
  • Page 22 If one or more test reminders have been set, the reminder symbol will always appear on the LCD screen when the meter is turned on. The display sample is shown below. The meter beeps 5 times when it is first set. It will beep again two minutes later, and two minutes after that unless you insert a test strip or press any button.

  • Page 23: Performing A Quality Control Test

    Performing a Quality Control Test The quality control test confirms that the test strips and meter are working together properly; it also confirms that you are performing the test correctly. It is important to perform this test: • Before you first use your meter. •...
  • Page 24 4. Shake the control solution bottle well. Squeeze it gently and discard the first drop. If the tip clogs, tap the tip gently on a clean, hard surface. Then shake again and use. Squeeze out a second small drop on a clean nonabsorbent surface. Touch the sample tip of the test strip to the control solution drop.
  • Page 25 Customer Support at 1-800-838-9502. Please contact Customer Support at 1-800-838-9502 for information on ® ordering the On Call Vivid Glucose Control Solution kit. The kit contains Control Solution 1 and Control Solution 2.

  • Page 26: Testing Your Blood

    ® The On Call Vivid Pal Blood Glucose Monitoring System requires a very small drop of blood. The blood may be obtained from the fingertip, palm (at base of the thumb) or forearm. Before testing, choose a clean, dry work surface.
  • Page 27 Fingertip Testing For fingertip sampling, adjust the depth penetration to reduce the discomfort. You do not need the clear cap for fingertip sampling. 1. Unscrew the lancing device cover from the body of the lancing device. Insert a sterile lancet into the lancet holder and push it until the lancet comes to a complete stop in the lancing device.
  • Page 28 3. Carefully screw the cover back onto the lancing device. Avoid contact with the exposed needle. Make sure the cover is fully sealed on the lancing device. 4. Adjust the puncture depth by rotating the lancing device cover. There are a total of 6 puncture depth settings.
  • Page 29 7. Hold the lancing device against the side of the finger to be lanced with the cover resting on the finger. Push the release button to prick your fingertip. You should hear a click as the lancing device activates. Gently massage from the base of the finger to the tip of the finger to obtain the required amount of blood.
  • Page 30 IMPORTANT: There are important differences among forearm, palm and fingertip samples that you should know. Important information about forearm and palm glucose testing: • You should consult your doctor before choosing to perform forearm or palm testing. • When blood levels are changing rapidly such as after a meal, an insulin dose or exercise, blood from the fingertips may show these changes more rapidly than blood from other areas.
  • Page 31 Note: To bring fresh blood to the surface of the puncture site, massage the puncture site vigorously for a few seconds until you feel it getting warm. 3. Place the lancing device against the puncture site. Press and hold the clear cap against the puncture site for a few seconds.
  • Page 32 2. Press the release button to make sure that the lancet is in the extended position. Slide the ejection button forward to discard the used lancet. Place the lancing device cover back on the lancing device. Lancet Precautions • Do not use the lancet if the safety tab is missing or loose when you take the lancet out of the bag.

  • Page 33: Step 2 - Testing Blood Glucose

    Step 2 – Testing Blood Glucose Note: Insertion of a new test strip at any time, except while in the data transfer mode (See page 35) will cause the meter to automatically enter the test mode. 1. Insert a test strip into the strip port, contact bars end first and facing up. This will turn on the meter and display all the display segments.
  • Page 34 3. Touch the blood drop to the sample tip at the end of the test strip. If the audio option is turned on, the meter will beep to indicate that the sample is sufficient and the measurement has started. If you applied a drop of blood, but do not see the countdown begin, you may reapply a second drop of blood within 3 seconds.
  • Page 35 When the meal marker feature is turned on, the test result is displayed together with the suggested default meal marker based upon current time. The “before meal” or “after meal” symbol is flashing until confirmed by pressing the <OK> button. The meter allows the user to change the meal maker.

  • Page 36: Hi" And "Lo" Messages

    ® • The On Call Vivid and On Call Vivid Pal meters, test strips and other components have been designed, tested and proven to work together effectively to provide accurate blood glucose measurements. Do not use components from other brands.
  • Page 37 Pal Blood Glucose Monitoring Systems. ® • On Call Vivid Pal Blood Glucose Monitoring System is not for use in critically ill patients. • Dispose of blood samples and materials with care. Treat all blood samples as if they are infectious materials. Follow all local regulations.

  • Page 38: Using The Meter Memory

    Using the Meter Memory The meter automatically stores up to 500 test records. Each record includes the test result, time and date. If there are already 500 records in memory, the oldest record will be erased to make room for a new one. The meter will also calculate the average values of records from the last 7, 14, 30, 60 and 90 days.
  • Page 39 5. While in data average mode: If the meal marker feature is off, press the <▲> or <▼> button to switch between the general 7, 14, 30, 60 and 90-day averages. If the meal marker feature is on, press the <▲> or <▼> button to switch between the 7, 14, 30, 60 and 90-day general, pre-meal and post-meal averages.

  • Page 40: Clearing The Memory

    The meter can transfer stored information to a Windows-based personal computer (PC) using an optional data transfer cable and software package. To ® make use of this feature, you need the On Call Diabetes Management Software and a data transfer cable from ACON.
  • Page 41 PC is completed, the meter will automatically turn off. In this case press both the <▲> and <▼> buttons to enter “PC” mode again. ® See the package insert included with your On Call Diabetes Management Software Kit for detailed instructions.

  • Page 42: Maintenance

    Replacing the Battery ® Your On Call Vivid Pal Meter uses one 3.0 Volt CR 2032 lithium battery. When the battery icon ( ) is blinking, it means the battery is running low. You should replace the battery as soon as possible. An “E-6” error message will appear if the battery is too low to perform any more blood glucose tests.
  • Page 43 5. Close the battery cover and make sure that it snaps shut. 6. Recheck and reset the clock setting after battery replacement, if necessary. To set the meter clock, see Meter Setup before Testing on page 14.

  • Page 44: Caring For Your On Call Vivid Pal Blood Glucose Monitoring System

    ® Please refer to the diagram for the On Call Vivid Pal meter and lancing device in the Getting Started section for meter and lancing device outside surface illustration.
  • Page 45 Please refer to the ® diagram for the On Call Vivid Pal meter in the Getting Started section for the strip port and data port location on the meter. Intended use for Disinfection and Pre-Cleaning before Disinfection The disinfection process is for preventing potential transmitting of infectious diseases through bloodborne pathogens.
  • Page 46 Pre-Cleaning and Disinfection Frequency If you run the test by yourself, you should pre-clean and disinfect your meter and lancing device periodically, such as at minimum of once a week, or whenever you feel the need to disinfect your meter and lancing device. If someone else assists you to run the test, the people who assist you or yourself should pre-clean and disinfect your meter and lancing device prior to each testing.
  • Page 47 The meter and lancing device appearance visual inspection items in the validation testing include: polymer crazing (thin silver streaks), cracking, swelling, dissolving, softening and becoming brittle. The meter functional inspection items in the validation testing include: All display segments verification after meter turn on; All meter set up verification including 12 or 24 Hour mode;...

  • Page 48: Suggested Testing Times And Target Goals

    Suggested Testing Times and Target Goals As a diabetic, it is important to track your blood glucose level frequently. Your doctor will help you decide the normal target range for your glucose levels. Your doctor will also help you determine when and how often you should test your blood glucose.
  • Page 49 Talk to your doctor to set your own daily target ranges. Time of Day Your Target Range Waking up (Fasting level) Before meals 2 hours after meals Bedtime 2 AM to 3 AM Other (Note: 1 mmol/L = 18 mg/dL) Use the logbook to record your blood glucose measurements and related information.

  • Page 50: Comparing Meter And Laboratory Results

    Comparing Meter and Laboratory Results ® Your On Call Vivid Pal Blood Glucose System and laboratory results both report the glucose concentration in the serum or plasma component of your blood. However, the results may differ somewhat due to normal variation. The meter results can be affected by factors and conditions that do not affect ®...

  • Page 51: Troubleshooting Guide

    Troubleshooting Guide The meter has built-in messages to alert you of problems. When error messages appear, note the error number. Turn off the meter and then follow these instructions. Display Causes Solution Battery may be damaged or empty. Replace the battery. Meter If the meter has been exposed to or stored in cold fails to...
  • Page 52 If the problem Improper type of test strip used. persists, please contact Customer Support at 1-800-838-9502. There is an error in transferring data to the PC. See ® the package insert included with the On Call Communications failure. Diabetes Management Software troubleshooting.

  • Page 53: Specifications

    Specifications Feature Specification Measurement Range 20 - 600mg/dL Plasma-equivalent, calibrated by using YSI (Model 2300 Result Calibration STAT PLUS) Glucose Analyzer reference instrument, which is traceable to NIST reference standard. Sample Adult capillary whole blood Minimum Sample Size 0.8 μL Test Time 5 seconds On/Off Source...

  • Page 54: Warranty

    Please complete the warranty card that came with this product and mail it to the following address: ® On Call Vivid Pal Warranty Center 10125 Mesa Rim Road San Diego, CA 92121-2915 If the meter fails to work for any reason other than obvious abuse within the first five (5) years from purchase, we will replace it with a new meter free of charge.

  • Page 55: Index Of Symbols

    Index of Symbols Consult instructions for use For in vitro diagnostic use only Store between 2 – 30 C (36 – 86 Contains sufficient for <n> tests Use by Lot Number Manufacturer Authorized Representative Sterilized using irradiation Control Range Catalog # Model Number MODEL Do not dispose along with household waste...

  • Page 56: Index

    Index Averaging Results ...... 33 <OK> Button....…... 4 Battery, Replacing the ....37 Specifications ..……....48 Carrying Case ......1 Procedure Clearing the Memory ....35 Precautions and Limitations..31 Data Port ........4, 35 Testing Your Blood ...... 21 Date Format ......

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