embrace Wave+ User manual

Sistema de Medidor de Glucosa en La Sangre
User's Manual
Manual De Usuario
Blood Glucose Monitoring System

1
Blood Glucose Monitoring System
Dear Embrace WAVE+ Owner
Thank you for choosing the Embrace® WAVE+ Blood Glucose Monitoring System to help
you easily monitoring your blood glucose. We hope it will be of great help to you in the
management of your diabetes. This manual explains how to use your new meter. Before
testing, carefully read through this manual and the package inserts that come with:
Embrace®WAVE Blood Glucose Test Strips, Embrace®WAVE Glucose Control Solution. Pay
particular attention to listed warnings and cautions. Please keep this manual on hand for
future reference.
Please call us at 1-877-979-5454 between 9:00 am and 5:00 pm EST, Monday through
Friday for questions and inquiries. If you have any questions or need assistance outside the
operational days and times, please contact your health care provider.
®

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Blood Glucose Monitoring System
Intended Use
The Embrace®WAVE+ Blood Glucose Monitoring System is comprised of the Embrace®
WAVE+ Blood Glucose Meter and the Embrace®WAVE Blood Glucose Test Strips.
The Embrace®WAVE+ Blood Glucose Monitoring System is intended for the quantitative
measurement of glucose in fresh capillary whole blood samples drawn from the ngertips,
forearm, or palm. Alternative site testing should be performed only during steady-state
(when glucose is not changing rapidly). It is intended for self testing outside the body
(in vitro diagnostic use) by people with diabetes at home as an aid in monitoring the
effectiveness of diabetes control and should only be used by a single patient and it should
not be shared. It is not indicated for the diagnosis or screening of diabetes or for neonatal
use.
IMPORTANT:
• Testing is done outside the body (In Vitro diagnostic use).
• Do not use test strips if expiration date has passed.
• Use Embrace®WAVE Blood Glucose Test Strips within 6 months of opening test strip
vial.

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Blood Glucose Monitoring System
Important Safety Instructions
• The meter and lancing device are for single patient use. Do not share them with anyone
including other family members! Do not use on multiple patients!
• All parts of the kit are considered biohazardous and can potentially transmit infectious
diseases, even after you have performed cleaning and disinfection.
• Users should wash hands thoroughly with soap and water after handling the meter,
lancing device, or test strips.
The links to the public health notication and standard practice guideline are:
• “FDA Public Health Notication: Use of Fingerstick Devices on More than One Person
Poses Risk for Transmitting Bloodborne Pathogens: Initial Communication” (2010) http://
www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm224025.htm
• “CDC Clinical Reminder: Use of Fingerstick Devices on More than One Person Poses
Risk for Transmitting Bloodborne Pathogens” (2010) http://www.cdc.gov/injectionsafety/
Fingerstick-DevicesBGM.html
Warning
• Use of this device on multiple patients may lead to transmission of Human
Immunodeciency Virus (HIV), Hepatitis C Virus (HCV), Hepatitis B Virus (HBV), or other
bloodborne pathogens.”

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Blood Glucose Monitoring System
Limitations
• Inaccurate results may occur in
• Severely hypotensive individuals
• Patients in shock
• In a hyperglycemic-hyperosmolar state with or without ketosis
• Do not use on critically ill patients.
• Do not use on neonates.
• Do not use the system above 10,335 feet (3,150 meters) in altitude.
• Do not use if hematocrit exceeds the acceptable range between 10% to 70% when testing
blood glucose.
• Severe dehydration (excessive water loss) may cause inaccurate results.
• For In Vitro Diagnostic only.
• For Over the Counter use.
• Perform an Alternative Site Testing (AST) only if your glucose level is not changing
rapidly.
• For single-patient use only.
• Do not use AST measurements to calibrate Continuous Glucose Monitors (CGMs).
• Do not use AST measurements for insulin dosing calculations.

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Blood Glucose Monitoring System
The following drugs do not generally interfere with the Embrace®WAVE+ Blood Glucose
Monitoring System at normal or therapeutic levels. However, higher concentrations (listed
below) were found to interfere with glucose measurements.
• If you are taking acetaminophen or acetaminophen containing drugs (for example
Tylenol; at blood concentrations > 10 mg/dL) you may get inaccurate results with this
system. If you are unsure, then please contact your doctor.
• If you are taking Paralidoxime Iodide (PAM) or Paralidoxime Iodide (PAM) containing
drugs at blood concentrations > 50 mg/dL, you may get inaccurate results with this
system. If you are unsure, then please contact your doctor.
• If you have certain conditions that may cause your blood level of uric acid to rise (> 15
mg/dL in your blood), such as gout or kidney disease, then your blood glucose results
may be inaccurate with this meter. If you are unsure, then please contact your doctor.
• Do not use during or soon after xylose absorption testing since xylose may cause
inaccurate glucose results. Ask your doctor how long to wait before performing a glucose
test.

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Blood Glucose Monitoring System
Table of Contents
Understanding Your New Blood Glucose Monitoring System
The Embrace®WAVE+ Blood Glucose Meter ..............................................9
The Embrace® WAVE+ Blood Glucose Meter Display Screen ................................11
The Embrace®WAVE Blood Glucose Test Strips ..........................................15
Embrace®WAVE Glucose Control Solution ...............................................16
Setting Up Your New System
Inserting (or Changing) the Battery .....................................................17
Clock Setup .........................................................................18
Alarm Setup ........................................................................21
Beeper Setup........................................................................24
Setting up Hypo/Hyper Warning Value ..................................................26
Control Solution Testing
Performing a Control Solution Test .....................................................32
Control Solution Trouble Shooting ......................................................37
Testing Your Blood Glucose
Preparing Your Lancing Device. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39
Important Information on Alternative Site Testing (AST) ...................................41
Performing a Blood Glucose Test.......................................................43

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Blood Glucose Monitoring System
Viewing Stored Readings from Memory ......................................50
Data Transmission
Upload Data Via Bluetooth.............................................................54
Caring for the Meter
Cleaning and Disinfecting Your Meter ...................................................59
Purchase Information for Clorox Healthcare Bleach Germicidal Wipes .......................63
Storage and Precautions ..................................................64
Solving Problems ........................................................66
Understanding Your Blood Glucose Test Results ...............................71
Product Warranty ........................................................72
Specications ............................................................73
Suppliers ...............................................................75
Accuracy for Home Use by Lay-Users........................................76
Federal Communications Commission Interference Statement ...................78

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Blood Glucose Monitoring System
Understanding Your New Blood glucose Monitoring System
The Embrace®WAVE+ Blood Glucose Meter is available as a Monitoring System (Starter
Kit/Value Pack) or a stand alone Meter. Each package includes the following items:
Package Conguration
Contents Monitoring System Meter
Embrace®WAVE+ Blood Glucose Meter V V
Instruction Manual V V
Quick Reference Guide V V
Carrying Case V V
Log Book V V
Embrace®WAVE Blood Glucose Test Strips (vial
or foil-wrapped)
V
Lancets & Lancing device V
Note:
• Embrace®WAVE Glucose Control Solution is required, but not provided and should be
purchased separately.
• The lancets and lancing device are not provided in the standalone Meter and will need
to be purchased separately by the user.
Please contact us at 1-877-979-5454 Monday through Friday from 9am to 5pm EST for
purchasing information.

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Blood Glucose Monitoring System
The Embrace WAVE+ Blood Glucose Meter
TEST STRIP PORT
This is where you insert the test strip and the meter will turn on automatically.
METER DISPLAY
Shows your blood glucose test results, memory values, averages, and other messages.
ENTER ( ) and (▲/▼) BUTTONS
Press and hold Enter ( ) for 2 seconds to turn on or off the meter, or press Enter ( ) to
enter setup mode when not testing.
Press “▲” or “▼” to enter control mode with test strip inserted, during meter setup, or to
navigate the stored test values and averages.
TEST STRIP PORT
(▲/▼) BUTTONS
ENTER ( )
METER DISPLAY
®

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Blood Glucose Monitoring System
BATTERY HOLDER
Holds two CR 2032 3V Lithium coin cell batteries.
BATTERY COMPARTMENT

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Blood Glucose Monitoring System
The Embrace WAVE+ Blood Glucose Meter Display Screen
®
BEEPER
ALARM
CLOCK
MEMORY
MAIN DISPLAY AREA
HYPO/ HYPER
UNIT
HOUR/MINUTES
DAY AVERAGE
BLOOD DROP
TEST STRIP
TEMPERATURE
BLE ICON
BATTERY
CONTROL SOLUTION
MODE (CTL)
MEAL MARKER
EXERCISE MARKER
ASTERISK MARKER

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Blood Glucose Monitoring System
MEMORY ........................................Indicates that you are using the memory
CLOCK ............................................Appears when setting date and time (see page 18);
ALARM ...........................................Appears when setting the alarm function (see page 21)
HYPO...............................................• Setting up your hypoglycemic threshold value (see page
26)
• Indicates your glucose test result maybe at or below your
hypoglycemic threshold value
• Indicates the memorized result maybe at or below your
hypoglycemic threshold value
HYPER ............................................• Setting up your hyperglycemic threshold value (see page
26)
• Indicates your test result maybe at or above your
hyperglycemic threshold value
• Indicates the memorized result maybe at or above your
hyperglycemic threshold value
BLOOD DROP ...............................This icon will ash to indicate that the meter is ready for
blood or control solution testing
MAIN DISPLAY AREA .................Displays test results, stored test values, result averages and
messages.
UNIT OF MEASUREMENT ...............Unit of measurement for your blood glucose is mg/dL
TIME ................................................Shows time (HH:MM, 12H AM/PM or 24H format).

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Blood Glucose Monitoring System
DAY AVERAGE..............................Shows the period related to the displayed average (1, 7, 14,
30, 60 or 90 days –(see page 50).
DATE............................................... Shows the date (MM-DD format)
WRONG TEMPERATURE ................Appears when it is either too hot or too cold to test (outside
the ranges of 50 °F~104 °F).
LOW BATTERY ............................. Appears when batteries need to be replaced (see page 17).
MEAL MARKER............................Displayed when marking a result as before or after meal, or
viewing a marked result (see page 46).
EXERCISE MARKER....................Displayed when marking a result as exercise, or viewing a
marked result (see page 47).
ASTERISK MARKER....................Displayed when marking a result as being unique or different
in some way, or viewing a marked result (see page 48).
CTL ..................................................Indicates a control solution test (see page 31)
BEEPER .........................................Appears when turning ON/OFF tone sound (see page 24)
TEST STRIP................................... This icon will ash to prompt you to insert a test strip for
testing
HOUR/MINUTES.......................... Displays time in 12-hour format or 24-hour format.

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Blood Glucose Monitoring System
BLE ICON....................................... Indicates the Bluetooth connectivity is turned ON
The icon is ashing rapidly. The meter is ready for a
device pairing.
The icon is ashing steadily. The meter has paired with
a mobile device and is transmitting data.
The icon is displayed without ashing. The meter has
paired with a mobile device and is waiting for instructions.

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Blood Glucose Monitoring System
The Embrace WAVE Blood Glucose Test Strips
The Embrace® WAVE Blood Glucose Test Strip is a glucose specic, biosensor-based test
strip that can test glucose in capillary whole blood in as quickly as 5 seconds and requires
very small blood sample. The test result is plasma referenced for easy comparison to lab
results. The test strip has under-ll detection to alert you when there is not enough blood
to perform a test, so you can be assured that every reading you get is an accurate and
meaningful result.
IMPORTANT:
• The Embrace®WAVE Blood Glucose Test Strip is sensitive to moisture and light. For vial
test strip, it is important to close the vial cap of the test strip bottle tightly after each
use. DO NOT leave any test strips outside the bottle while not in use.
For Foil-wrapped test strips, do not open the foil wrapping until performing the test.
• DO NOT reuse test strips. Test strips are for single use only.
• Carefully discard used test strips and lancets in proper waste containers.
• Be sure to use only the Embrace®WAVE Blood Glucose Test Strip with the Embrace®
WAVE+ Blood Glucose Meter. Other brands of test strips will not work with the meter.
Contact Points
Insert this end to the test
strip port on the meter
Sampling End
Apply blood or control solution
here
®

16
Blood Glucose Monitoring System
Embrace WAVE Glucose Control Solution
Call your local supplier or pharmacy to order control solution. If they do not stock it, please
contact us at 1-877-979-5454 Monday through Friday from 9am to 5pm EST.
The Embrace®WAVE Glucose Control Solution is required to perform a glucose
control solution test. The solutions are available at 2 concentrations. Embrace®WAVE Low
(L1) Glucose Control Solution helps you to validate the performance of your system at a
low range blood glucose reading, while High (L2) solution helps you to validate your system
performance at a high range blood glucose reading. Please see Control Solution Testing
section on page 31.
®

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Blood Glucose Monitoring System
Setting Up Your New System
Inserting (or Changing) the Battery
Batteries need to be changed when the “ ” icon appears on the meter
display.
Materials you will need:
• Two CR 2032 3V Lithium coin cell batteries
• Your Embrace®WAVE+ Blood Glucose Meter
Step 1.
Turn meter off. Remove the battery cover on the back of the meter by
pushing the tab and pulling the cover up. Remove the old batteries.
Step 2.
Insert the new batteries with the + side up. They do not snap into place
but rest on the metal contact. The cover holds the batteries down.
Put the battery cover back in place and snap it closed.

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Blood Glucose Monitoring System
NOTE:
• After changing the batteries, the meter automatically prompts you to check the time and
date when it is turned on either by inserting a test strip or pressing “ ”. If it is correct,
press “ ” to conrm setup and exit, or if the time and date are not correct, turn to page
18 for Setting the Clock.
• The stored results in memory will not be erased when the batteries are being changed.
• Discard used batteries according to your local regulations.
• The meter uses two CR 2032 3V Lithium coin cell batteries and can be found in most
retail stores or on Amazon.com. Always keep a spare package of batteries on hand.
• Be sure the batteries go in + side up.
• Remove the batteries if the meter is not used for a long period of time.
Clock Setup
Material you will need:
• Your Embrace®WAVE+ Blood Glucose Meter
Begin Set Up
Step 1.
Press and hold “ ” to turn on the meter.

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Blood Glucose Monitoring System
Step 2.
The ashing test strip icon will appear on the meter display screen
Step 3.
Press “▲” twice and the meter display screen shows “ ”.
Set Year
Step 4.
Press “ ” and the current year will ash. Press “▲” or “▼” to select the
correct year.
Press “ ” to conrm your choice and advance to set the month
Set Month
Step 5.
The current month will ash. Use “▲” or “▼” to select the correct month.
Press “ ” to conrm your choice and advance to set the day.