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Contour NEXT ONE User Manual

Contour NEXT ONE
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Blood Glucose Monitoring System
USER GUIDE
Uses only CONTOUR
®
NEXT
blood glucose test strips.
Works with free CONTOUR
®
DIABETES app.
Warranty information and online meter registration
available at www.diabetes.ascensia.com/warranty
or call our Customer Service.

Other manuals for Contour NEXT ONE

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Contour NEXT ONE Specifications

General IconGeneral
Measurement Range20-600 mg/dL
Sample Size0.6 µL
Test Time5 seconds
BluetoothYes
ConnectivityBluetooth
Battery TypeTwo CR2032 3V lithium batteries
Memory Capacity800 results
Weight36 g
Operating Temperature5-45°C (41-113°F)
Operating ConditionsTemperature: 5°C to 45°C, Humidity: 10% to 93% RH

Summary

Intended Use

Important Safety Information

Consult Your Healthcare Professional

Consult your doctor before changing treatment or if results differ from how you feel.

Potential Biohazard

All kit parts are biohazardous. Handle with care and follow cleaning and disinfection procedures.

Limitations and Specifications

System Usage Restrictions

Not for critically ill, shock, hypoxia, or hyperglycemic-hyperosmolar states. Specific operating conditions apply.

Operating Conditions

Details meter temperature, humidity, sample volume, measuring range, altitude, AST, hematocrit, and xylose interference.

Precautions for Use

Handling Meter and Test Strips

Always use original bottle, keep tightly closed, avoid humidity, heat, cold, dust, dirt.

Using Materials and Equipment

Do not use expired materials. Use approved equipment. Check expiration dates.

Result Display and Range

Getting Started

Meter and Test Strip Overview

Identifies meter buttons, test strip port, and sample tip for blood application.

Navigation and Inactivity

Use OK to exit screens. Screen dims after 30 seconds inactivity; press any button to wake.

Meter Screen Components

Meter Symbols and Meanings

Explains symbols for target range indicators, HI/LO results, logbook, settings, and markers.

Key Meter Features

Meter Features: No Coding & Second-Chance

Highlights 'No Coding' and 'Second-Chance' sampling features for easier and more accurate blood application.

Contour Diabetes App

App Features and Benefits

Perform setup, add notes, set reminders, view graphs, share reports, track results against targets.

Downloading the App

Instructions to download from App Store or Google Play, search, and install the CONTOUR DIABETES app.

Initial Meter Setup

Setup via Contour Diabetes App

Easiest setup method: download app, follow in-app instructions to pair meter.

Setup from the Meter

Alternative setup: press and hold OK for 3 seconds to turn on, then follow on-screen prompts.

Setting Meter Time and Date

Set the Time

Instructions to change hour and minutes using meter buttons, including AM/PM selection for 12-hour format.

Set the Date

Select m/d or d.m format. Change year, month, day using buttons.

Setup Complete

Confirms setup completion with a beep and meter turn-off. Meter is ready for testing.

Testing Procedures

Get Ready to Test

Read guide, check parts, ensure meter works with CONTOUR NEXT strips/solution. Avoid expired materials.

Fingertip Testing Materials

Ensure you have meter, test strips, lancing device, and lancets. Quality control checks are in Section 5.

Low Blood Glucose Symptoms

Lists common symptoms of hypoglycemia (low blood glucose) like shakiness, sweating, fast heartbeat, etc.

High Blood Glucose Symptoms

Lists symptoms of hyperglycemia (high blood glucose) and ketones (ketoacidosis), advising to test if experienced.

Blood Sample Collection

Prepare Lancing Device

Single-patient use only. Do not reuse lancets. Refer to lancing device insert for preparation.

Insert Test Strip

Remove strip, insert grey square end until meter beeps. Do not use expired materials.

Apply Blood to Test Strip

Remove strip, insert into port. Screen shows blinking blood drop. Apply blood to tip within 3 minutes.

Fingertip Sample Collection

Wash hands. Press lancing device, touch strip tip to blood drop. Hold until meter beeps.

Correct Blood Application

CAUTION: Do not press strip tip on skin or place blood on top. Use only the tip for sample.

Test Result Features

Second-Chance Sampling

If meter beeps twice, apply more blood to the same strip within 60 seconds if not enough blood was drawn.

Meal Markers Explained

Attach Meal Markers (Fasting, Before Meal, After Meal) to results when feature is On.

Add Meal Markers to Results

Select a Meal Marker when meter displays result if feature is On. Do not press OK or remove strip yet.

Select Meal Marker

Scroll through markers using buttons, press OK to select. Timeouts apply for selection or meter turn-off.

Test Completion Display

Meter displays result with units, time, date, marker, and target indicator.

Target Light (smartLIGHT) Indicator

Test strip port displays color (Green, Red, Yellow) for In Target, Below, Above target ranges.

Test Result Interpretation

Interpreting Test Results

Consult doctor for medication changes. Follow advice for critical low or high readings; retest if needed.

Expected Test Result Values

Nondiabetic fasting <100 mg/dL, postprandial <140 mg/dL. Consult HCP for personal values.

Handling LO or HI Results

LO (<20 mg/dL) requires contacting HCP. HI (>600 mg/dL) requires retesting; contact HCP if persistent.

Alternative Site Testing (AST)

AST Warnings and Conditions

Ask HCP if AST is right. Do not calibrate CGM or calculate insulin dose from AST. Do not use if glucose is low or changing rapidly.

Lancet Ejection and Disposal

Logbook Functionality

Review Logbook

Press/hold OK to turn on. Select Logbook symbol. Scroll through individual test results using buttons.

Meter Settings

Settings Options

Change time/date format, sound, markers, target ranges, lights, Bluetooth. Save settings with OK.

Access Meter Settings

Press/hold OK to turn on. From Home screen, highlight Settings symbol, press OK to enter.

Exit Meter Settings

To exit Settings at any time, press and hold OK. The meter turns off.

Change Time Format and Time

Select 12/24 hour format. Change hour, minutes, and AM/PM using buttons.

Change Date Format and Date

Select m/d or d.m format. Change year, month, day using buttons.

Configure Meter Sound

Turn sound On/Off. Beeps indicate confirmation or errors. Some sounds remain active.

Enable Meal Markers

Turn Meal Markers On/Off. When On, select markers during tests. Displays Target Range screens.

View Target Ranges

Discuss target range settings with HCP. Meter displays Fasting, Before Meal, After Meal, Overall ranges.

Configure Target Lights (smartLIGHT)

Turn Target Lights On/Off. Green=In Target, Red=Below Target, Yellow=Above Target.

Configure Bluetooth

Turn Bluetooth On/Off. Bluetooth is available after pairing meter with a mobile device.

Pair Meter with App

Turn meter off, press/hold OK until flashing blue light. Follow app instructions to match serial number.

Meter Care and Maintenance

Meter Care and Storage

Store in case, wash/dry hands, handle carefully, avoid extreme conditions. Clean/disinfect as recommended.

Meter Durability and Disinfection

Meter tested for 260 cycles (5 years) of cleaning/disinfection. Contact CS for malfunctions or display changes.

Cleaning and Disinfection

Cleaning and Disinfection Warnings

Wash hands. All parts are biohazardous. Disinfect before second-person use. Single-patient use.

Recommended Cleaning Agent

Use Clorox Germicidal Wipes (0.55% sodium hypochlorite). Purchase online. Contact CS for assistance.

Cleaning Procedure

Clean meter with germicidal wipes until soil is removed. Dry with paper towel. Avoid liquid entry into ports.

Disinfection Procedure

Keep meter surfaces wet with germicidal wipe for 60 seconds. Dry with paper towel. Clean lancing device separately.

Data Transfer

Transfer Results to App

Wirelessly transfer results to smartphone/tablet. Pair meter via app as described in Getting Started.

Transfer Results to PC

Requires diabetes management software and USB cable. Ensure USB port is closed. Use only approved equipment.

Batteries and Control Solution

Battery Indicators

Low battery symbol appears normally. Dead batteries stop testing; replace immediately.

Replace Meter Batteries

Turn off meter, slide cover, remove old batteries, insert two CR2032/DL2032. Settings saved if replaced within 5 mins.

Control Solution Warnings

Use only CONTOUR NEXT control solution. Shake well. Do not apply directly from bottle. Do not use expired solution.

When to Perform Control Test

Perform when using meter for first time, opening new strips, suspecting malfunction, or getting unexpected results.

Control Solution Storage and Testing

Store between 48-86°F. Test when temperature is 59-95°F. Results are not included in logbook or app.

Control Solution Testing Procedure

Remove strip, insert into port. Shake control solution 15x. Touch strip tip to drop. Compare result to range.

Technical Information

Error Detection Displays

Meter displays error codes (E + number) for test, strip, or system errors. Beeps twice. Press OK to turn off.

Strip Error Codes

Lists E1 (Too Little Blood), E2 (Used Strip), E3 (Upside Down), E4 (Wrong Strip), E6 (Moisture), E8 (Strip Errors) with actions.

Testing and System Error Codes

Lists testing errors (E20, E24, E25, E27, E28) and system errors (E30-E99) with troubleshooting steps.

Customer Service Checklist

When calling CS, have meter, strips, control solution ready. Locate model/serial number and check battery status.

Meter Kit Contents

Meter Kit Components

Lists meter, user guide, quick reference, test strips, control solution, lancing device, lancets, carrying case by model number.

System Accuracy and Precision

System Accuracy Results

Presents accuracy data for glucose concentrations below 75 mg/dL and at/above 75 mg/dL vs lab methods.

Repeatability Precision Study

Shows mean, SD, 95% CI of SD, and CV for repeatability across different glucose levels.

Intermediate Precision Study

Shows precision results for control levels 1, 2, and 3, including mean, SD, 95% CI of SD, and CV.

FCC Certification and Compliance

FCC Compliance and Interference

Equipment meets FCC Part 15 limits for Class B digital devices. Lists measures to correct interference.

Device Operation Guidelines

Device should not affect other devices. Increase distance or turn off interfering devices/Bluetooth for interference.

Specifications Overview

Key Meter Specifications

Details sample type, result reference, countdown, memory, battery, dimensions, weight, meter life, sound, RF, and EMC.

Product Labeling Symbols

Explains symbols used on product labeling: Control Discard Date, Shake 15 times.

Standard Medical Device Symbols

Explains ISO/IEC symbols: Catalog Number (REF), Batch Code (LOT), In Vitro Diagnostic (IVD) Medical Device.

Principle of Operation

Glucose Test Mechanism

Measures electrical current from glucose reaction with reagents. Blood drawn via capillary action. No user calculation needed.

Comparison Options and Glycolysis

System uses capillary whole blood. Comparison needs simultaneous aliquots. Glucose drops rapidly due to glycolysis.

References

Cited References

Lists references from FDA, CDC, journal articles on blood glucose monitoring, disease, and testing.

Contact Information and Trademarks

Customer Service Availability

Available Mon-Sun, 8am-12am ET. For medical emergencies, contact HCP or 911. Leave message for callback.

Trademarks and Licensing

Lists Ascensia trademarks and licensing information. Apple, Bluetooth, Google Play are also mentioned.

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