embrace Wave+ Manual de usuario
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 notication and standard practice guideline are:
• “FDA Public Health Notication: 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
Immunodeciency 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
Specications ............................................................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 Conguration
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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