i-SENS CareSens N Plus BT User Manual

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owned by Bluetooth® SIG, Inc. and any use of such marks by
i-SENS, Inc. is under license. All other trademarks and trade
names are those of their respective owners.
This equipment complies with FCC radiation exposure limits set
forth for an uncontrolled environment.
This equipment should be installed and operated with minimum
distance 8 inches (20 cm) between the radiator and your body.
Any changes or modifications not expressly approved by the
manufacturer could void the user's authority to operate this
equipment.
WARNING:
Turn off the Bluetooth feature in areas where the use of
wireless devices is restricted, such as hospitals, some healthcare
professional offices, and airplanes.
Trademarks
FCC Radiation Exposure Statement:
Note:
The SmartLog mobile app may not be compatible
with all smartphones.

i-SENS CareSens N Plus BT Specifications

General

Brand	i-SENS
Model	CareSens N Plus BT
Category	Blood Glucose Meter
Language	English

Summary

Trademarks

FCC Radiation Exposure Statement

Important Information

Intended Use

Describes the system's intended purpose and diagnostic use.

Meaning of Symbols Used

Explains symbols used for safety and product usage guidance.

Important Safety Information

Provides crucial safety instructions for device usage.

Limitations of CareSens N Plus BT Blood Glucose Monitoring System

Lists factors that can affect test accuracy and system limitations.

Specifications

Product Specifications

Details technical attributes like result range, sample size, test time, and power.

Operating Ranges

Specifies environmental conditions for meter operation, including temperature and humidity.

Storage and Transport Conditions

Outlines recommended temperature and humidity for storing the meter and test strips.

CareSens N Plus BT Blood Glucose Monitoring System

System Components

Lists the items included in the CareSens N Plus BT meter package.

Inserting or Replacing the Batteries

Battery Replacement Steps

Guides on opening the compartment, removing old batteries, and inserting new ones.

Battery Type Caution

Warns to use only CR2032 non-rechargeable batteries.

Inserting or Replacing the Batteries - Continued

Closing Battery Compartment

Explains how to close the battery compartment cover securely.

Note on Stored Results

Clarifies that removing batteries does not affect stored results but may require resetting settings.

Meter Handling Precautions

Lists precautions for meter handling and storage to prevent damage.

CareSens N Blood Glucose Test Strip

Test Strip Usage Guide

Details inserting the strip, identifying contact bars, and applying blood.

CareSens N Plus BT Blood Glucose Meter Features

Key Warnings and Cautions

Lists critical warnings and precautions for test strip usage, handling, and safety.

Meter Components and Functionality

Details the data port, display, buttons, and test strip port of the meter.

Notes on Meter Operation

Provides information on data cable ordering and fixed units of measurement.

CareSens N Plus BT Blood Glucose Meter Display

Display Screen Elements Overview

Identifies and explains the numbered elements on the meter's display screen.

Setting Up Your System

Entering Setup Mode

Guides on initiating the meter's setup mode by pressing and holding a button.

Setting Up Bluetooth

Bluetooth Pairing Procedure

Explains the steps for pairing the meter with a smartphone via Bluetooth.

Entering Pairing PIN

Details how to enter the PIN number on the app to complete the pairing process.

Bluetooth Symbol Indicator

Clarifies the meaning of the Bluetooth symbol on the screen and how to toggle the feature.

Setting Up Bluetooth - Continued

Pairing Confirmation and Data Transfer

Describes entering the PIN on the app and confirming successful pairing and data transfer.

Data Transfer Completion Status

Explains the 'End' message after data transfer and what to do if it fails.

Adjusting the Date and Time

Setting the Year and Month

Guides on setting the current year and month using the meter's buttons.

Setting the Date

Guides on setting the current date using the meter's buttons.

Adjusting the Date and Time - Continued

Setting Time Format (12/24 Hour)

Explains how to select between 12-hour and 24-hour clock formats.

Setting Hour and Minute

Guides on setting the current hour and minute using the meter's buttons.

Setting the Sound On/OFF

Sound Alert Configuration

Details how to turn the meter's sound alerts on or off.

When Meter Beeps

Lists specific instances when the meter will produce an audible beep.

Turning on the Strip Expiration Date Indicator

Strip Expiration Warning Setup

Explains how to enable or disable the strip expiration date warning.

Turning on the Hypoglycemia (HYPo) Indicator

Hypoglycemia Alert Configuration

Guides on enabling the HYPO indicator and setting a low blood sugar alert level.

Hypoglycemia Warning Display

Shows how the meter alerts the user when a low blood glucose level is detected.

Caution on Hypoglycemia Setting

Advises consulting a healthcare professional before setting the hypoglycemia level.

Setting the Strip Expiration Date Indicator

Accessing Expiration Date Settings

Details how to access the expiration date setting mode.

Setting Year and Month

Guides on setting the year and month for the strip expiration date.

Checking the System

Using Control Solution for Verification

Explains the use of control solution to verify meter and strip functionality.

Control Solution Testing Notes

Provides important notes regarding control solution usage, expiration, and storage.

Control Solution Testing

Inserting Test Strip and Flagging

Details inserting the test strip and how to flag control solution results.

Applying Control Solution to Strip

Guides on preparing and applying the control solution to the test strip.

Viewing Control Result and Meter Behavior

Describes result display, storage, and notes on meter behavior.

Control Solution Testing - Continued

Comparing Control Results to Range

Explains how to compare the meter result with the range on the test strip vial.

Caution on Test Strip Range Use

Clarifies that the test strip vial range is for control solution only, not blood glucose.

Note on Ordering Control Solution

Provides contact information for ordering control solution separately.

Comparing the Control Solution Test Results

Situations Causing Out-of-Range Results

Lists common situations that might lead to control solution test results falling outside the expected range.

Actions for Out-of-Range Results

Provides guidance on repeating tests or discarding solutions based on out-of-range results.

Using the Lancing Device

Lancing Device Components Identification

Identifies the adjustable tip, lancet holder, and ejection system.

Preparing the Lancing Device

Hygiene and Tip Removal

Instructs hand washing and removing the adjustable tip.

Lancet Insertion and Tip Replacement

Details inserting a new lancet, removing its cover, and replacing the tip.

Adjusting Tip and Cocking Device

Explains aligning the tip and cocking the device.

Lancet Use Safety Caution

Warns against reusing lancets and emphasizes using new sterile lancets and keeping the device clean.

Preparing the Lancing Device - Continued

Setting Puncture Depth

Guides on selecting the puncture depth setting from 0 to 5.

Note on Skin Depth Variation

Explains that skin depth varies and the adjustable tip helps achieve adequate sample size.

Cock the Lancing Device

Details how to cock the lancing device by pulling the sliding barrel.

Preparing the Meter and Test Strip

Inserting the Test Strip

Instructs inserting the test strip into the meter's port until it beeps.

Applying Blood Sample

Obtaining and Applying Blood

Guides on obtaining a blood sample using the lancing device and applying it to the strip.

Applying Blood Sample - Continued

Applying Blood to Strip Until Beep

Details applying blood to the strip until the meter beeps and potential error messages.

Note on Sample Application Timing

Notes meter behavior if blood sample is not applied promptly.

Reading Test Results and Storage

Explains how the test result is displayed after counting down and automatic storage.

Note on Bluetooth Data Transmission

Lists requirements for transmitting glucose data using the Bluetooth feature.

Applying Blood Sample - Continued

Attaching Flags to Test Results

Explains how to attach flags (pre-meal, post-meal, fasting, control) to test results.

Discarding Used Lancets

Lancet Disposal Procedure

Guides on safely disposing of the used lancet in a biohazard container.

Lancet Safety and Handling

Provides safety warnings regarding lancet sharpness, storage, and single-use policy.

HI and Lo Messages

HI Message Explanation

Explains the 'HI' message indicating a blood glucose level above 600 mg/dL.

Lo Message Explanation

Explains the 'Lo' message indicating a blood glucose level below 20 mg/dL.

Note on Persistent HI/Lo Readings

Advises contacting customer service for persistent HI or Lo results.

Target Blood Glucose Ranges

Normal Blood Glucose Expectations

Provides general guidelines for normal blood glucose levels for adults.

Reference Standards

Cites the American Diabetes Association standards for blood glucose levels.

Transferring Test Results

Using SmartLog Software for Data Transfer

Explains how to transfer test results to a computer using SmartLog software.

Meter Memory

Memory Capacity and Management

States the meter can save up to 1,000 test results and how full memory is handled.

Viewing Averages Stored in Meter Memory

Viewing 1-Day and General Averages

Describes how to view the 1-day average and number of tests saved.

Viewing 7, 14, 30, 90-Day Averages

Guides on viewing 7, 14, 30, and 90-day averages and test counts.

Viewing Pre-meal, Post-meal, and Fasting Averages

Explains how to view specific types of averages and their counts.

Meter Memory - Continued

Scrolling Averages and Turning Off Meter

Guides on scrolling back through averages and turning off the meter.

Note on Control Solution Averages Exclusion

Clarifies that control solution results are not included in averages.

Viewing Test Results Stored in Memory

Initial Display of Stored Results

Describes the initial display of date, time, 1-day average, and test count.

Scrolling Through Stored Test Results

Guides on scrolling through stored test results from most recent to oldest.

Note on Control Solution Result Symbol

Mentions that control solution results have a specific symbol.

Setting the Alarm Function

Overview of Alarm Types

Lists the four types of alarms available: post-meal and three time-set alarms.

Setting the Post-meal Alarm (PP2)

Enabling the PP2 Alarm

Details the steps to turn the post-meal alarm on.

Disabling the PP2 Alarm

Details the steps to turn the post-meal alarm off.

Note on PP2 Alarm Auto-Deactivation

Clarifies when the PP2 alarm automatically turns off.

Setting Time Alarms (1-3)

Entering Time Alarm Setup Mode

Guides on entering the time alarm setting mode.

Configuring Alarm 1 (On/Off)

Explains how to set or cancel Alarm 1.

Setting Alarm 1 Hour

Guides on setting the hour for Alarm 1.

Setting Time Alarms (1-3) - Continued

Setting Alarm 1 Minute

Guides on setting the minute for Alarm 1.

Setting Alarms 2 and 3

Instructs to repeat steps to set Alarms 2 and 3.

Finalizing Alarm Settings

Guides on finishing the alarm settings and turning off the meter.

Caring for Your System

General Precautions for System Care

Emphasizes minimizing blood-borne pathogen transmission and washing hands.

Pre-cleaning and Disinfection Necessity

Details the need for pre-cleaning and disinfection procedures for the meter and lancing device.

Recommended Disinfection Frequency

Suggests performing pre-cleaning and disinfection once a week.

Note on Meter Service Life

Mentions the meter's 5-year lifespan and validated disinfection cycles.

Caring for Your System - Continued

Validated Disinfectant Information

Provides information on Clorox Healthcare Bleach Germicidal Wipes as a validated disinfectant.

Pre-cleaning and Disinfection Procedures

Meter Disinfection Steps

Step-by-step instructions for disinfecting the meter using wipes.

Note on Disinfectant Availability

Advises where to purchase the recommended disinfectant product.

Note on Pre-cleaning Order

Emphasizes performing pre-cleaning before disinfecting.

Pre-cleaning and Disinfection Procedures - Continued

Lancing Device Disinfection Steps

Repeats the disinfection procedure for the lancing device.

Post-Disinfection System Check

Advises performing a control solution test after cleaning to ensure proper function.

Note on Signs of Deterioration

Lists signs indicating meter deterioration and when to contact customer service.

Caution Regarding Cleaners and Fluids

Warns against using unvalidated cleaners and getting fluids into the meter.

Storage and Handling Cautions

Provides cautions regarding exposure to sunlight, heat, dust, blood, and water.

Understanding Error Messages

Er1: Used Test Strip Error

Explains the error for using a previously inserted test strip.

Er2: Premature Sample Application Error

Details the error for applying sample before the symbol appears.

Er3: Temperature Out of Operating Range Error

Explains the error related to testing outside the specified temperature range.

Er4: Insufficient Blood Sample Error

Describes the error for insufficient blood sample volume.

Note for Technical Assistance

Provides contact information for technical assistance and customer service.

Understanding Error Messages - Continued

Er5: Incorrect Test Strip Error

Explains the error for using an incorrect type of test strip.

Er6: Meter Malfunction Error

Indicates a general problem with the meter and advises not to use it.

Er7: Bluetooth Communication Error

Addresses problems with Bluetooth communication and advises contacting customer service.

Er8: Electronic Test Error

Explains an electronic error during testing and when to contact customer service.

Note on Persistent Error Messages

Advises contacting customer service if error messages persist.

General Troubleshooting

Troubleshooting a Blank Display

Provides steps to troubleshoot a blank display after inserting a test strip.

Troubleshooting Test Start Issues

Offers solutions if the test does not start after applying blood.

Troubleshooting Mismatched Test Results

Lists steps to take if the test result does not match the user's feeling.

Note for Unresolved Troubleshooting Issues

Advises contacting customer service if troubleshooting does not resolve the problem.

Performance Characteristics

Accuracy Evaluation Methodology

Details the accuracy assessment of the system compared to a laboratory instrument.

User Performance Data

Shows user performance results for glucose concentrations within a specific range.

Precision Study Design

Outlines precision studies performed in a laboratory setting.

Within-Run Precision Data

Presents data on precision within a single run for various blood glucose levels.

Between-Run Precision Data

Presents data on precision between different runs, including control averages.

Performance Characteristics - Continued

Accuracy Results Below 75 mg/dL

Shows accuracy results for glucose concentrations below 75 mg/dL.

Accuracy Results Above 100 mg/dL

Shows accuracy results for glucose concentrations of 100 mg/dL and above.

EMC Table

Electromagnetic Compatibility Declarations

Presents the manufacturer's declaration and additional EMC information as per IEC standard.

Warranty Information

Manufacturer's Warranty Terms

Outlines the warranty terms, duration, and coverage for the meter.

Procedure for Obtaining Warranty Service

Provides instructions on how to obtain warranty service for the meter.