i-SENS Caresens N Feliz Manual
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i-SENS Caresens N Feliz Manual

i-SENS Caresens N Feliz Manual

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Information
Important Information: Read This First! ................................ 5
Specifications ....................................................................... 9
Inserting or Replacing the battery ...................................... 12
CareSens N Feliz Blood Glucose Meter ............................. 17
Preparation
Setting Up Your System ...................................................... 21
Setting the Sound On/OFF ............................................. 24
Setting the Hypoglycemia (Lo) Indicator ........................ 27
Setting the Hyperglycemia (Hi) Indicator ........................ 28
Setting the Strip Expiration Date Indicator ......................... 30
Checking the System .......................................................... 31
Control Solution Testing .................................................. 33
Testing
Using the Lancing Device ................................................... 39
Preparing the Lancing Device ......................................... 40
Preparing the Meter and Test Strip ................................. 43
Applying Blood Sample .................................................. 43
Discarding Used Lancets ................................................ 48

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  • Page 1: Table Of Contents

    Information Important Information: Read This First! ........ 5 Specifications ............... 9 CareSens N Feliz Blood Glucose Monitoring System ..11 Inserting or Replacing the battery ........12 CareSens N Single Blood Glucose Test Strips ....14 CareSens N Feliz Blood Glucose Meter ......17 CareSens N Feliz Blood Glucose Meter Display ....
  • Page 2 HI and Lo Messages ............49 Target Blood Glucose Ranges ..........50 Transferring Test Results Using Cable ....... 51 Additional Functions Meter Memory ..............52 Viewing Averages Stored in Memory ......52 Viewing Test Results Stored in Memory ......55 Post-meal alert and Time Alarm .........

  • Page 3: Important Information: Read This First

    Important Information: Read This First! Intended use: The CareSens N Feliz Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips. The CareSens N Feliz Blood Glucose Monitoring...
  • Page 4 • CareSens N Single Blood Glucose Test Strips are intended for single use only. They should be disposed of in an appropriate container immediately after use. Limitations of CareSens N Feliz Blood Glucose Monitoring System • An abnormally high or low red blood cell count (hematocrit level over 65 % or below 15 %) may produce inaccurate results.
  • Page 5 • The single-patient use system and lancing device are for single-patient use only and should not be shared with anyone including other family members. • This device is not intended for use in healthcare or assisted use settings such as hospitals, physician offices or long-term care facilities because it has not been cleared by the FDA for use in these settings, including for routine assisted testing or as part of glycemic control...
  • Page 6 The CareSens N Feliz meter detects this electrical current and measures the amount of glucose in the blood sample. The CareSens N Feliz blood glucose meter is designed to • minimize code related errors in monitoring by using the no-coding function.

  • Page 7: Specifications

    Specifications Product specifications Measurement range 20–600 mg/dL Sample size Minimum 0.5 μL Test time 5 seconds Sample type Fresh capillary whole blood Calibration Plasma-equivalent Assay method Electrochemical Battery life 1,000 tests Power One 3.0 V lithium battery (disposable, type CR2032) Memory 1,000 test results Size...
  • Page 8 Storage/Transport conditions Glucose Meter 32–122 °F (with battery) Temperature Test strip 34–86 °F Control solution 46–86 °F Relative Test strip 20–80 % humidity...

  • Page 9: Caresens N Feliz Blood Glucose Monitoring System

    CareSens N Feliz Blood Glucose Monitoring System CareSens N Feliz System includes the following items: CareSens N Feliz Blood Glucose Meter • User Manual • Quick Reference Guide • Battery • CareSens N Feliz System may include the following items: CareSens N Single Blood Glucose Test Strips •...

  • Page 10: Inserting Or Replacing The Battery

    Inserting or Replacing the battery The CareSens N Feliz meter uses one 3.0 V lithium battery. Before using the meter, check the battery compartment and insert a battery if empty. When the symbol appears on the display while the meter is in use, the battery should be replaced as soon as possible.
  • Page 11 Step 3 Place the cover on the battery compartment. Push it down until you hear the tab click into place. Note Removing the meter battery will not affect your stored results. However, you may need to reset your meter settings. See page 21.

  • Page 12: Caresens N Single Blood Glucose Test Strips

    CareSens N Single Blood Glucose Test Strips The CareSens N Feliz Blood Glucose Monitoring System measures blood glucose quickly and accurately. It automatically absorbs the small blood sample applied to the narrow edge of the strip. Contact bars Gently push the test strip,...
  • Page 13 Warning: The CareSens N Single Blood Glucose Test Strips should • be used only with fresh capillary whole blood samples. Do not reuse test strips. • Do not use test strips past the expiration date. • Test strips in new, unopened vials and test strips in •...
  • Page 14 For detailed storage and usage information, refer to the • CareSens N Single Blood Glucose Test Strip package insert. Keep the meter and testing supplies away from young • children. Drying agents in the vial cap may be harmful if inhaled or •...

  • Page 15: Caresens N Feliz Blood Glucose Meter

    CareSens N Feliz Blood Glucose Meter Data Port Display Used to transfer Shows results, data from the messages meter to a computer with a cable Button Turns the meter on/off, confirms menu selections, , Button and changes Turns the meter...

  • Page 16: Caresens N Feliz Blood Glucose Meter Display

    CareSens N Feliz Blood Glucose Meter Display 12 13 14 test results displaying panel 1 Test results appears when test results stored 2 Memory recall in the memory are displayed mode appears when in SET mode 3 Setting symbol appears when the post-meal...
  • Page 17 appears when the control 6 Control solution test results are saved or Solution flag displayed appears when the test result is 7 Hyperglycemia greater than the selected or user symbol pre-set hyperglycemia level appears when the test result is within the selected normal blood 8 Smile symbol glucose range appears when the test result is...

  • Page 18: Battery Symbol

    indicates meter battery is running low and needs to be % Battery symbol replaced indicates meter is ready for the ^ Blood insertion application of a drop of blood or symbol control solution & Month/Day/Hour/Minute Note It is recommended to check if the display screen on the meter matches the illustration above every time the meter turns on.

  • Page 19: Setting Up Your System

    Setting Up Your System Press and hold the button for 3 seconds to enter SET mode. After all settings are finished, press and hold the  button for 3 seconds to turn off the meter. Press the or button to change values. Press and hold the  or button to scroll faster.
  • Page 20 Step 3 Setting the Month A number indicating the month will blink on the screen. Press the or button until the correct month appears. Press the  button to confirm your selection and to go to the next step. Step 4 Setting the Date Press the or button until the screen displays the correct date.
  • Page 21 Step 6 Setting the Hour Press the or button until the correct hour appears. After the hour is set, press button to go to the next step. Step 7 Setting the Minute Press the or button until the correct minute appears. After setting the minute, press the button to go to the next step.

  • Page 22: Setting The Sound On/Off

    Setting the Sound On/OFF Step 8 On pressing the or button, the screen will display 'On' or 'OFF'. Press the  button to confirm the selection. The meter will beep in the following instances if set to On: When you push a button to turn on the •...

  • Page 23: Turning On The Strip Expiration Date Indicator

    Turning on the Strip Expiration Date Indicator Step 9 This setting allows you to turn the strip expiration date indicator on or off. This setting turns the function on or off only. See page 30 to set the strip expiration date. When 'EP' appears on the screen, press the or  button.
  • Page 24 Note If the pre-set expiration date expires, the meter will display 'EP' when the test strip is inserted. 'EP' shows alternately also when the test result is displayed right after the test. If the expiration date is set to October of 2024, the meter will display 'EP' at the start of October, 2024.

  • Page 25: Setting The Hypoglycemia (Lo) Indicator

    Setting the Hypoglycemia (Lo) Indicator Step 10 This setting allows you to select the desired level for the hypoglycemia indicator (possible low blood sugar). You will be alerted any time your test result is lower than the selected level. Press the or button until the desired hypoglycemia level between 20 and 90 mg/dL appears.

  • Page 26: Setting The Hyperglycemia (Hi) Indicator

    Setting the Hyperglycemia (Hi) Indicator Step 11 This setting allows you to select the desired level for the hyperglycemia indicator (possible high blood sugar). You will be alerted any time your test result is higher than the selected level. Press the or button until the desired hyperglycemia level between 120 and 349 mg/dL appears.
  • Page 27 Note If the test result is within the normal blood glucose level (between the pre- set hypoglycemia and hyperglycemia levels), the smile symbol will be displayed on the screen as shown.

  • Page 28: Setting The Strip Expiration Date Indicator

    Setting the Strip Expiration Date Indicator Step 1 Entering the Expiration Date Setting Press and hold the and buttons at the same time for 3 seconds to enter the expiration date settings. After all segments flash across the screen, 'EP' will show up. Note The strip expiration date is printed on the test strip vial.

  • Page 29: Checking The System

    Control Solution Range Written on Strip Vial. Discard Date : Manufacturer: i-SENS, Inc. The test strip vials have CareSens Glucose 43, Banpo-daero 28-gil, Seocho-gu, Seoul 06646, Korea PGA2E0580 REV9 2021-12 Control Solution ranges printed on their labels.
  • Page 30 Note Use only the CareSens Glucose Control Solution • (Level A and/or B, available for purchase separately). Check the expiration date printed on the bottle. • When you first open a control solution bottle, record the discard date (date opened plus three (3) months) in the space provided on the label.

  • Page 31: Control Solution Testing

    You may do a control solution test: When you want to practice the test procedure using the • control solution instead of blood, When using the meter for the first time, • Whenever you open a new vial of test strips, •...
  • Page 32 Step 2 Activating Control Solution Test Mode Press and hold the button for 3 seconds to activate the Control Solution Test Mode. This will also flag the control solution test result. To undo the control solution flag, press and hold the button for another 3 seconds.
  • Page 33 Note The meter may switch off if the control solution sample is not applied within 2 minutes of the symbol appearing on the screen. If the meter turns off, remove the strip, reinsert, and start from step 1. Step 4 Waiting for the Result A test result will appear after the meter counts down from 5 to 1.
  • Page 34 Step 5 Comparing the Result Compare the result displayed on the meter to the range printed on the test Control Solution Range strip vial. The result should fall within Control A: XXX–XXX mg/dL the range. Control B: XXX–XXX mg/dL Caution The range printed on the test strip vial is for the CareSens Glucose Control Solution only.

  • Page 35: Comparing The Control Solution Test Results

    Comparing the Control Solution Test Results The test result of each control solution should be within the range printed on the label of the test strip vial. Repeat the control solution test if the test result falls outside of the range. Out of range results may occur in following situations: Situations Do This...
  • Page 36 If results continue to fall outside the range printed on the test strip vial, the CareSens N Single Blood Glucose Test Strip and CareSens N Feliz meter may not be working properly. Do not use your system and contact Customer Service at 1-800-429-5001 (9 am–6 pm PST, Monday–...

  • Page 37: Using The Lancing Device

    You will need a lancing device in order to collect a blood sample. You may use the lancing device that is included in the CareSens N Feliz Blood Glucose Monitoring System or any other medically approved lancing device. Ejection System...

  • Page 38: Preparing The Lancing Device

    Preparing the Lancing Device Step 1 Wash hands and sample site with soap and warm water. Rinse and dry thoroughly. Step 2 Unscrew and remove the lancing device tip. Step 3 Firmly insert a new lancet into the lancet holder. Hold the lancet firmly.
  • Page 39 Step 4 Turn the adjustable tip until it is aligned with the load confirmation window and release button as shown. Step 5 The lancing device has six puncture depth settings, numbered 0 through 5 (0 for a shallow puncture, 5 for a deeper puncture).
  • Page 40 Step 6 To cock the lancing device, hold the body of lancing device in one hand and pull the sliding barrel with the other hand. The device is loaded when you feel a click and the load confirmation window turns red. Note The skin depth to get blood samples will vary for various people at different sample sites.

  • Page 41: Preparing The Meter And Test Strip

    Preparing the Meter and Test Strip Step 7 Insert a test strip with the contact bars facing upwards into the meter’s test strip port. Push the strip in gently until the meter beeps. Be careful not to bend the test strip. The symbol will appear on the screen.
  • Page 42 Step 9 After the symbol appears on the screen, apply the blood sample to the narrow end of the test strip till the meter beeps. If the confirmation window is not filled in time because of abnormal viscosity (thickness and stickiness) or insufficient volume, the Er4 message may appear.
  • Page 43 Caution Do not allow any foreign substances, such as dirt, blood, or water, enter into the meter. The meter may be damaged or may malfunction. Follow the warning information provided below to prevent possible damage to the meter. Do not apply the blood sample directly to the test •...
  • Page 44 Step 10 The test result will appear after the meter counts down from 5 to 1. The result will be automatically stored in the meter’s memory. If the test strip is removed after the test result is displayed, the meter will automatically switch off after 3 seconds.
  • Page 45 Step 11 You can attach a flag to a result to indicate particular situations while the strip is still in the meter. When the result is displayed right after a test, press the or button to select a pre-meal flag ( ), a post-meal flag ( ), a fasting flag (...

  • Page 46: Discarding Used Lancets

    Discarding Used Lancets Step 1 Unscrew the lancing device tip. Step 2 Stick the lancet into the saved protective disk. Push the lancet ejector forward with the thumb to dispose of the used lancet in a proper biohazard container. Caution The lancet is for single use only.

  • Page 47: Hi And Lo Messages

    HI and Lo Messages HI Message The meter displays results between 20–600 mg/dL. 'HI' appears when the blood glucose level is greater than 600 mg/dL and indicate severe hyperglycemia (much higher than normal glucose levels). If 'HI' is displayed again upon retesting, please contact your healthcare professional immediately.

  • Page 48: Target Blood Glucose Ranges

    Target Blood Glucose Ranges Reminders Your target ranges from your healthcare professional Time of day Before breakfast Before lunch or dinner 1 hour after meals 2 hours after meals Between 2 a.m. and 4 a.m. Expected Values : Normal blood glucose levels for an adult without diabetes are below 100 mg/dL before meals and fasting* and are less than 140 mg/dL two hours after meals.

  • Page 49: Transferring Test Results Using Cable

    Transferring Test Results Using Cable Test results stored in the CareSens N Feliz meter can be transferred from the meter to a computer using SmartLog software and cable. The meter screen displays 'PC' when it is connected to the computer using the data cable.

  • Page 50: Meter Memory

    Meter Memory The CareSens N Feliz meter can save up to 1,000 glucose test results with time and date. If the memory is full, the oldest test result will be deleted and the latest test result will be stored. The meter calculates and displays the averages of total test...
  • Page 51 Step 2 Viewing Averages Press the button button to view 7, 14, 30 Average and 90-day average (1, 7, 14, 30, 90 days) values and the number of tests button performed for the last test period. Step 3 Viewing Pre-meal Averages Repeatedly press the button button to view 1,...
  • Page 52 Step 4 Viewing Post-meal Averages Press the button button to view 1, 7, 14, Post-meal 30 and 90-day average (1, 7, 14, 30, average values and 90 days) the number of tests performed post- button meals with the  symbol for the last test period. Step 5 Viewing Fasting Averages Press the button...

  • Page 53: Viewing Test Results Stored In Memory

    Step 6 Use the button to scroll back through the averages seen previously. Press the button to turn off the meter. Note The control solution test results saved with the  symbol are not included in the averages. Viewing Test Results Stored in Memory Step 1 Press the , or button to turn the...
  • Page 54 Step 2 Use the button to button scroll through the test results, starting from the most recent and ending with the button oldest. Press the button to return to the result seen previously. After checking the stored test results, press the  button to turn off the meter.

  • Page 55: Post-Meal Alert And Time Alarm

    Post-meal alert and Time Alarm You can set the post-meal alert (PP2 alert) and time alarm in the CareSens N Feliz meter. The PP2 alert starts to ring 2 hours after setting the alarm and lasts for 15 seconds. To stop the alarm, press any button or insert a test strip.
  • Page 56 Step 2 Turning the PP2 alert OFF To turn off the PP2 alert, press and hold the  button for 3 seconds. 'PP2', bell ( ) symbol and 'OFF' will appear on the screen. Then disappears the screen will change automatically to the memory recall mode without bell ( symbol displayed.

  • Page 57: Setting The Time Alarms (Alarm 1-3)

    Setting the Time Alarms (alarm 1–3) Step 1 Without inserting a test strip, press and hold the and buttons simultaneously for 3 seconds to enter the time alarm settng. 'alarm 1' will be displayed while 'OFF' blinks on the screen. Step 2 On pressing the button, 'alarm 1' is set and 'On' is displayed on the screen.
  • Page 58 Step 4 On pressing the button, the number indicating the minute will start blinking. Press the button to set the minute. Step 5 Press the button to finish and to go to 'alarm 2' setting. Repeat steps 2 to 4 to set the remaining time alarms (alarm 2–3).

  • Page 59: Caring For Your System

    Caring for Your System To minimize the risk of transmission of blood-borne • pathogens, the cleaning and disinfection procedure should be performed as recommended in the instructions below. Wash your hands thoroughly with soap and water after • handling the meter, lancing device, or test strips. If the meter is being operated by a second person who •...
  • Page 60 Note The life span of a CareSens N Feliz meter is 5 years. We recommend disinfecting both the meter and lancing device at least once per week. We have validated a total of 260 cleaning and disinfecting cycles (260 cleaning and...
  • Page 61 Name Clorox Healthcare Bleach Germicidal ® Wipes Manufacturer Clorox Professional ® Products Company [Phone] 1 800 537 1415 [Website] www.cloroxprofessional.com EPA registration 67619-12 number Active Sodium Hypochlorite: 0.55 % ingredients Note The disinfectant products can be purchased through online retailers (e.g. Amazon or Walmart) or by calling the Clorox ®...
  • Page 62 Cleaning and Disinfection Procedures: Open the cap ① of the Clorox Healthcare Bleach Germicidal Wipes container and pull out 1 towelette and close the cap. Wipe the entire surface of the meter 3 times horizontally ② and 3 times vertically, in a back and forth motion, using one towelette to clean blood and other body fluids.
  • Page 63 Pull out 1 new ④ towelette and wipe the entire surface of the meter 3 times horizontally and 3 times vertically using a new towelette to disinfect bloodborne pathogens. Dispose of the used towelette in a trash bin. ⑤ Allow exteriors to remain wet for 1 minute. ⑥...
  • Page 64 Caution Do not use other cleaners or disinfectants because • other chemicals have not been validated and may damage the meter. Do not get fluids inside the meter through the test strip • port, data transmission port or battery compartment. Never immerse the meter or hold it under running water because this will damage the meter.
  • Page 65 Note If any of the following deterioration signs appear after cleaning or disinfecting, please stop using the system and contact Customer Service at 1-800-429-5001 (9 am–6 pm PST, Monday–Friday). At all other times or in case of emergency, contact your healthcare professional or emergency medical response. When the inscriptions on the exterior of the meter (or •...
  • Page 66 Keep the meter away from strong electromagnetic field • sources such as cell phones and microwave ovens. The CareSens N Feliz meter should be used only with • CareSens N Single Blood Glucose Test Strips. Store all meter components in the carrying case to •...
  • Page 67 Use of accessories, transducers and cables other than • those specified or provided by i-SENS could result in increased electromagnetic emissions or decreased electromagnetic immunity of this equipment and result in improper operation. Note You can get additional information or technical assistance by calling our Customer Service at 1-800-429-5001 (9 am–6 pm PST, Monday–Friday).

  • Page 68: Understanding Error Messages

    Understanding Error Messages A used test strip was inserted. > Repeat the test with a new test strip. The blood or control solution sample was applied before the symbol appeared. > Repeat the test with a new test strip and wait until the symbol appears before applying the blood or control...
  • Page 69 This error message may appear when the wrong blood glucose test strip is used instead of CareSens N blood glucose test strip. > Repeat the test with a CareSens N Single Blood Glucose Test Strip. There is a problem with the meter. >...
  • Page 70 Note If the error messages persist, please contact Customer Service: 1-800-429-5001 (9 am–6 pm PST, Monday– Friday). At all other times or in case of emergency, contact your healthcare professional or emergency medical response.

  • Page 71: General Troubleshooting

    General Troubleshooting Problem Troubleshooting Check whether the test strip is • inserted with the contact bars facing up. Check if the strip has been inserted completely into the test strip The display is port. blank even after inserting Check if the appropriate test strip •...
  • Page 72 Note If the problem is not resolved, please contact Customer Service: 1-800-429-5001 (9 am–6 pm PST, Monday– Friday). At all other times or in case of emergency, contact your healthcare professional or emergency medical response.

  • Page 73: Performance Characteristics

    The performance of CareSens N Feliz Blood Glucose Monitoring System has been evaluated in laboratory and in clinical tests. Accuracy: The accuracy of the CareSens N Feliz Blood Glucose Monitoring System was assessed by comparing blood glucose results obtained by patients with those obtained using a YSI Model 2300 Glucose Analyzer, a laboratory instrument.
  • Page 74 48 mg/dL and 553 mg/dL. Within ±15 mg/dL and Within ±20 % 371/371 (100 %) Precision: The precision studies were performed in a laboratory using the CareSens N Feliz Blood Glucose Monitoring Systems. Within Run Precision 43 mg/dL SD = 1.9 mg/dL CV = 4.3 %...

  • Page 75: Warranty Information

    Warranty Information Manufacturer’s Warranty i-SENS, Inc. warrants that the CareSens N Feliz Meter shall be free of defects in material and workmanship in normal use for a period of five (5) years. The meter must have been subjected to normal use. The warranty does not cover improper handling, tampering, use, or service of the meter.
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