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USER GUIDE

V1.0

REMOTE CARE PARTNERS

PAGE 47

CONTACT INFORMATION AND NOTICES

Remote Care Partners

855-477-7000

www.remotecarepartners.com

FCC Compliance Statement

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.

This equipment generates, uses, and can radiate
radio frequency energy and, if not installed and
used in accordance with the instructions, may
cause harmful interference to radio
communications.

However, there is no guarantee that interference
will not occur in a particular installation. 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 encouraged to try to correct the
interference by one or more of the following
measures:

•

Reorient or relocate the receiving
antenna.

•

Increase the separation between the
equipment and the receiver.

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Summary of Contents for CONTOUR NEXT ONE

Page 1: ...CONTOUR NEXT ONE Glucose Meter CONTOUR NEXT ONE Glucose Meter...

Page 2: ...meter Screen 10 Initial Setup from the Meter 11 View Pre Set Target 12 Set the Date 13 GETTING READY TO TEST 14 Insert a test strip into the meter 16 Get the Blood Drop Fingertip Testing 17 Apply Mor...

Page 3: ...olution Testing 30 LOGBOOK 33 Review the Logbook 33 SETTINGS 34 Access Settings 34 Change the Time 35 Change the Date 35 TECHNICAL INFORMATION USER ACCURACY 37 TECHNICAL INFORMATION PRECISION 38 SYMPT...

Page 4: ...r is provided 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 CAUTION You...

Page 5: ...hazardous and can potentially transmit infectious diseases even after cleaning and disinfected all parts 3 Do not place the device in liquid or put it where it could fall into the liquid 4 Use of this...

Page 6: ...his piece screw the cap back on and adjust the puncture depth usually 3 Prepare the meter Insert a test strip into the meter Push the strip into the meter until it stops and the meter beeps Perform th...

Page 7: ...iabetes at home as an aid in monitoring the effectiveness of a diabetes control program The Contour next ONE blood glucose monitoring system should not be used for the diagnosis of or screening for di...

Page 8: ...PARTNERS V1 0 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 must be changed after each use Ster...

Page 9: ...e OK button until the meter turns Off The or buttons on the meter allow you to scroll through the options You can hold the or button to scroll continuously through a list Press the OK button to accept...

Page 10: ...CONTOUR NEXT ONE Glucose Meter PAGE 10 REMOTE CARE PARTNERS V1 0 Your Contour next ONE meter Screen Test Strip Port Time Test Result in Target Meal Marker Date...

Page 11: ...nd the white strip port briefly light up It is very important to verify that 8 8 8 displays fully and that the white light from the test strip port is visible If there are missing characters or if the...

Page 12: ...K button Continue to Set the Time Set the Time The hour is blinking To change the hour press the or button on the outer ring To set the hour and move to minutes press the OK button To change the minut...

Page 13: ...press the or button then press the OK button 2 To change the month press the or button then press the OK button 3 To change the day press the or button then press the OK button The meter briefly displ...

Page 14: ...t test strips Lancing device and lancets from your kit if provided 1 Remove the endcap from the lancing device 2 Loosen the round protective cap on a lancet by rotating the cap turn but do not remove...

Page 15: ...USER GUIDE V1 0 REMOTE CARE PARTNERS PAGE 15 5 Replace the endcap 6 Rotate the endcap dial to adjust the puncture depth The amount of pressure applied to the puncture site also affects puncture depth...

Page 16: ...after you have removed the test strip 3 Hold the test strip with the gray square end face toward the meter 4 Insert the grey square end firmly into the test strip port until the meter beeps The scree...

Page 17: ...ze around the puncture site 3 Test immediately after you have formed a small round blood drop as shown 4 Immediately touch the tip of the test strip to the drop of blood The blood is drawn into the te...

Page 18: ...does not have enough blood 2 Apply more blood to the test strip within 60 seconds 3 If the screen displays an E1 error message remove the strip and start with a new strip Eject and Dispose of the Use...

Page 19: ...I screen your blood sugar reading is over 600 mg dL 1 Wash and dry your hands well 2 Retest with a new strip If results are still over 600 mg dL follow medical advice immediately Reference value Time...

Page 20: ...ity heat cold dust or dirt Clean and disinfect your meter as recommended in the next section The cleaning and disinfecting directions should not cause any damage or degradation to the external case bu...

Page 21: ...diseases Evaluate your device after cleaning and disinfection to ensure that the procedure does not cloud the meter s face display and does not corrode or erode the plastic housing or buttons For mor...

Page 22: ...l Wipes containing 0 55 sodium hypochlorite bleach Paper towels 1 Carefully clean the meter with germicidal wipes until all soil is removed 2 Dry as necessary with a clean paper towel CAUTION Do not a...

Page 23: ...ur Meter 2 Using a new germicidal wipe carefully wipe all outer surfaces of your meter until wet NOTE For proper disinfection you must keep all meter surfaces wet for 60 seconds 3 After wiping for 60...

Page 24: ...es immediately When you see this symbol you can only test about 10 more times over the next 3 days before the batteries are dead The meter operates normally displaying the Low Batteries symbol until y...

Page 25: ...E If you put the new batteries in the meter within 5 minutes of taking the old batteries out the meter saves all your settings and results Always check the date and time after you replace the batterie...

Page 26: ...V1 0 8 Slide the battery holder back into place 9 Discard batteries according to your local environmental regulations WARNING Keep batteries away form children Many types of batteries are poisonous I...

Page 27: ...n displays error codes E plus a number for test result errors strip errors or system errors When an error occurs the meter beeps 2 times and displays an error code Press the OK button to turn off the...

Page 28: ...CONTOUR NEXT ONE Glucose Meter PAGE 28 REMOTE CARE PARTNERS V1 0 Speak to a Customer Service representative before returning your meter for any reason Contact RCP Customer Care at 1 855 477 7000...

Page 29: ...when Using your meter for the first time You open a new bottle or package of test strips You think your meter may not be working properly You have repeated unexpected blood sugar results Level 1 and L...

Page 30: ...strip into the test strip port until the meter beeps The meter turns on displaying a test strip with a flashing blood drop NOTE If this is the first time you are opening the control solution write th...

Page 31: ...solution onto a clean nonabsorbent surface 8 Immediately touch the tip of the test strip to the drop of control solution 9 Hold the tip in the drop until the meter beeps CAUTION Do not apply control s...

Page 32: ...ntrol test result with the range printed on the test strip bottle or on the bottom of the test strip box 11 Remove the test strip and dispose of as medical waste If your result does not fall within th...

Page 33: ...the Logbook 1 Press and hold the OK button until the meter turns on about 2 seconds The Logbook is blinking 2 To select the blinking Logbook symbol press the OK button 3 To view your individual test r...

Page 34: ...ime Change the date format Change the date You must accept or change each setting with the OK button before moving to the next one Access Settings 1 Press and hold the OK button until the meter turns...

Page 35: ...button 3 To change the minutes press the or button then press the OK button 4 For a 12 hour time format select AM or PM as needed then press the OK button Change the Date If your meter is not ON 1 Pre...

Page 36: ...press the or button then press the OK button 6 To change the year blinking press the or button then press the OK button 7 To change the month blinking press the or button then press the OK button 8 To...

Page 37: ...The results were compared to the YSI Glucose Analyzer laboratory reference method traceable to the CDC hexokinase method The following accuracy results were obtained Table 1 System accuracy results f...

Page 38: ...monitoring system using 5 venous whole blood specimens with glucose levels from 43 mg dL to 333 mg dL With each blood specimen each of 3 lots of Contour Next test strips was tested 10 times on each of...

Page 39: ...control solutions at 3 glucose levels With each control solution each of 3 lots of Contour Next test strips was tested once on each of 10 instruments on 10 separate days for a total of 300 readings Th...

Page 40: ...ose Hypoglycemia shakiness sweating fast heartbeat blurred vision confusion passing out seizure irritability extreme hunger dizziness High blood glucose Hyperglycemia frequent urination excessive thir...

Page 41: ...41 F 113 F Control Testing Temperature Range 59 F 95 F Meter Operating Humidity Range 10 RH 93 RH Test Strip Storage Conditions 41 F 86 F 10 80 Relative Humidity RH Dimensions 97 mm L x 28 mm W x 14...

Page 42: ...test is based on measurement of electrical current caused by the reaction of the glucose with the reagents on the electrode of the test strip The blood sample is drawn into the tip of the test strip t...

Page 43: ...Human Services update 11 29 2010 http www fda gov MedicalDevices Safety Alerts andNotices ucm224025 htm 2 Centers for Disease Control and Prevention CDC clinical reminder use of fingerstick devices o...

Page 44: ...noted below During the stated 5 year period Ascensia Diabetes Care shall at no charge replace a unit found to be defective with an equivalent or current version of the owner s model Limitations of War...

Page 45: ...test strips and therefore does not warrant the performance of the Contour next ONE meter when used with any test strips other than Contour next test strips or when the Contour next test strip is alte...

Page 46: ...TES CARE HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES 11 Some States do not allow the exclusion or limitation of incidental or consequential damages so the above limitation or exclusion may not...

Page 47: ...ipment generates uses and can radiate radio frequency energy and if not installed and used in accordance with the instructions may cause harmful interference to radio communications However there is n...

Page 48: ...T ONE Glucose Meter PAGE 48 REMOTE CARE PARTNERS V1 0 Connect the equipment into an outlet different from that to which the receiver is connected Consult the dealer or an experienced radio TV technici...

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