EPS Bio Technology EastMax LTC User manual

Long Term Care (LTC) Self-Monitoring Blood Glucose System
User’s Manual
Please read this User’s Manual thoroughly
before using this blood glucose meter.

Introduction
Welcome to the EasyMax LTC Self-Monitoring Blood Glucose (SMBG) System. This system is dependable and
easy-to-use, utilizing a compact, lightweight and portable meter that will aide you in monitoring your patients’
blood glucose levels.
Please read this manual thoroughly before you begin testing. It provides you and your diabetes care team
important information and step-by-step directions for use of the EasyMax LTC Self-Monitoring Blood Glucose
System.
Intended Use
The EasyMax LTC Self Monitoring Blood Glucose Test System is intended for the quantitative
measurement of glucose in fresh capillary whole blood samples drawn from the fingertip, palm or forearm.
Testing is done outside the body (In Vitro diagnostic use). The EasyMax LTC Blood Glucose System can be
used by a single patient or for multiple-patient use in professional healthcare settings, as an aid to monitor the
effectiveness of diabetes control. When used in Long Term Care Settings, this system must be used with safety
lancets. The system is not to be used on neonates, nor for the diagnosis of, or screening for, diabetes mellitus.

Important Safety Instructions
In Long Term Care settings, use only single-use safety lancets, and a new safety lancet should be used for
each test.
All parts of the kit are considered biohazardous and may transmit infection, even if you have performed
cleaning and disinfection. Wash hands thoroughly with soap and water after handling the meter. Follow
Standard Precautions when using the meter and obtaining a sample. A new pair of gloves should be worn by
the user before testing each patient.
The meter should be disinfected after each use. The EasyMax LTC Self Monitoring Blood Glucose Test
System may be used for testing multiple patients when Standard Precautions and the disinfection procedures
included in this manual are followed.
EasyMax LTC Blood Glucose Meter Accessories:
• EasyMax 15 Blood Glucose Test Strips
• EasyMax 15 Level 1 (Low) Control Solution
• EasyMax 15 Level 2 (Normal) Control Solution
• User’s Manual
• 2 AAA batteries

For further information, please see:
"Biosafety in Microbiological and Biomedical Laboatories (BMBL)"
http://www.cdc.gov/biosafety/publications/bmbl5/
"Protection of Laboratory Workers From Occupationally Acquired Infections; Approved Guideline--Third Edition
" Clinical and Laboratory Standards Institute (CLSI) M29-A3.
“Guideline for Isolation Precautions: Preventing Transmission of Infectious Agents in Healthcare Settings 2007”,
http://www.cdc.gov/hicpac/2007ip/2007isolationprecautions.html.
“FDA Public Health Notification: 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

Why is it so important to test blood glucose regularly?
Testing blood glucose regularly can make a big difference in how you or your patient manages their day to day
diabetic care. We’ve made EasyMax LTC Self-Monitoring Blood Glucose System as simple as possible to help
you use it regularly.
Do you need help?
If you have questions or need assistance, please call the Customer Care Service toll-free at 866-994-3345
(Eastern Standard Time, Mon-Fri 8:00AM-6:00PM).

Important Information about your new EasyMax LTC Meter
The EasyMax LTC Blood Glucose Meter is designed and approved for testing fresh capillary whole blood
samples from the fingertip, palm and forearm. The meter is for in vitro use ONLY (for testing outside the
body). It should not be used to diagnose diabetes.
Remove batteries if the meter will not be used for one month or more.
The EasyMax LTC Blood Glucose Meter can only be used with EasyMax 15 Blood Glucose Test Strips.
Other test strips will give inaccurate results. EasyMax 15 Blood Glucose Test Strips feature a unique and
accurate glucose dehydrogenase chemistry system.
Testing is not valid for neonatal blood specimens.
Do not disassemble the meter as this may cause damage to the components resulting in incorrect
readings. Disassembling the meter will also void the warranty.
Always keep the meter clean and store it in a safe place. Protect the meter from direct sunlight to ensure a
longer lifespan.
You should not store the meter and test strips in a car, a bathroom or a refrigerator.
Keep the meter, test strips and safety lancets away from children and pets.
You should not test critically ill patients with home-use blood glucose meters.
Critically ill patients should not be tested with blood glucose meters. See page 9 for more information.

Warning for potential biohazard: Healthcare professionals using this system on multiple patients should be
aware that all products or objects that come in contact with human blood, even after cleaning, should be
handled as if capable of transmitting viral disease.
Note:
Do not touch the strips with wet hands.
Do not use expired strips (the expiration date is shown on the vial.)
Do not bend, cut or twist the strips.
Altitude up to 10,000 feet above sea level has no effect on readings.

Health-Related Information
If the patient is experiencing dehydration, frequent urination, low blood pressure, shock or hyperosmolar
hyperglycemic nonketotic coma (HHNKC), you may get a test result that is lower than the actual blood
glucose level. We recommend confirming the result on such patients via a clinical laboratory.
If you have followed the steps in the user’s manual, but your patient still has symptoms that don’t seem to
match their test results, or if you have questions, please call the Customer Care Service toll-free at
866-994-3345 (Eastern Standard Time, Mon-Fri 8:00AM-6:00PM).
Healthcare personnel should wash hands and change gloves between patients, even if patient-dedicated
testing devices and single-use lancing devices are used.
Note: Warning for potential biohazard:
Healthcare professionals using this system on multiple patients should handle all products or
objects in contact with human blood carefully to avoid transmitting viral disease, even after
cleaning.

Explanation of Meter Symbols
Date
(on the left side)
Medical Record No.
(patient number)
Time
(on the right side)
Apply Control Solution
Apply blood Unit
Result / Message Battery
Insert a strip Temperature

Table of Contents
Chapter 1: Understanding Your Meter …........................................................................................................12
EasyMax LTC Blood Glucose Meter …......................................................................................................12
The EasyMax LTC Accessories..................................................................................................................13
Inserting Batteries........................................................................................................................................14
Setting the Time, Date and Medical record..................................................................................................15
Using EasyMax 15 Blood Glucose Test Strips …...…………………...........................................................17
Chapter 2: Control Solution Test ....................................................................................................................18
When to Run a Control Solution Test ..........................................................................................................18
About Control Solution ................................................................................................................................19
Running a Control Solution Test .................................................................................................................20
Understanding Control Solution Test Results ….........................................................................................22
Chapter 3: Testing Blood Glucose ........................................................................................................24
Instructions for Using Safety Lancets…………………………………………………......................................24
Running a Blood Glucose Test with Blood from Fingertip ..................................................................26
Understanding Test Results …...........................................................................................................29
Unusual Test Results …..............................................................................................................................29

Chapter 4: Meter Memory, Setup …................................................................................................................30
Memory, Storing Test Result …...................................................................................................................30
Viewing and Deleting Test Results…...........................................................................................................31
Using With Your Computer…......................................................................................................................32
Chapter 5: Maintenance and Troubleshooting …..........................................................................................33
Battery Information......................................................................................................................................33
Cleaning and Disinfecting the EasyMax LTC Meter in LTC Settings...........................................................34
Cleaning And Disinfection Frequency..........................................................................................................38
Maintenance and Testing ...........................................................................................................................39
Screen Messages and Troubleshooting …..................................................................................................40
Chapter 6: Technical Information …...............................................................................................................44
Specifications …..........................................................................................................................................44
Limitations.................................................................................................................................................45
Device Information …..................................................................................................................................48
Warranty......................................................................................................................................................48

12
Chapter 1: Understanding Your Meter
EasyMax LTC Blood Glucose Meter
Display-
Shows results,
patient numbers,
and messages.
Left ()Button-
Press to enter memory,
adjust setting, and
scroll through results.
Test Strip Slot-
Insert a test strip here.
Battery Door-
Flip open the battery
door by pushing the
tab in the direction of
the arrow and pulling
the door up.
Right () Button-
Press to enter
memories, adjust setting,
and scroll through
results.
Power Button-
Press to turn on/off
the meter, and to
confirm the setting.
Strip Ejector-
Push the strip ejector
up to remove the
strip.

13
The EasyMax LTC Accessories
EasyMax 15 Blood Glucose Test Strip Test Strip Bottle &
Control Solution Bottle
Expiration Date
Strip Insert
Direction
Reaction area
Hand Hold
Area
Blood collection
area
Electrode

14
Inserting Batteries
1. Open the battery door on the back of the meter by pushing the tab in the direction of the arrow and
pulling the door up.
2. Insert two AAA batteries. The meter will beep to confirm the batteries are inserted correctly.
3. Put the battery door back in place and snap it closed.

15
Setting the Time, Date and Medical record — First Time Use
Setting the current time and date on your meter is important if you use the meter memory.
2. Press (Right button) for 2
seconds to get into the setting
mode.
3. The screen display flashes the
last 2-digits of the year. Press
(Left button) or (Right button)
to adjust the year and press
Power Button to confirm the
setting.
1. Press (Power Button)
and hold the button until
the meter turns on.

16
4. Repeat step 3 to set the date and time.
The flashing field is the one you are
currently setting.
5. Press (Left button) or (Right button) to turn on/off the
function of medical record number and press (Power
Button) to confirm the setting.
Note:
1. When the function of is on, it allows you to keep testing records of multiple users separate
by marking them from 001-999.
2. The meter defaults to the medical record function being “ ”. Press (Right button) to reset
this function.

17
Using EasyMax 15 Blood Glucose Test Strips
Use only with EasyMax LTC or EasyMax NG Blood Glucose Meters.
EasyMax LTC Self-Monitoring Blood Glucose System is a no code system and does not require test strip
calibration.
EasyMax LTC Self-Monitoring Blood Glucose System utilizes glucose dehydrogenase chemistry to avoid
incorrect readings on patients receiving Oxygen therapy.
Run a control solution test every time you open a new box of strips (See Chapter 2 “Control Solution
Testing.”)
After you take a test strip out of the vial, tightly close the vial immediately to keep the test strips dry.
Use the test strip within three minutes after taking it out of the vial.
The strip is for single use only. Do not reuse it.
When you open a new test strip vial, check the expiration date. The test strips are good for six months
from the initial date the vial is opened or until the expiration date, whichever comes first. Record the date
you first open the test strip vial in the designated spot on the vial.
Store the test strip vial and your meter in a cool, dry place, between 36°F - 86°F (2°C- 30°C). Do not
freeze.
Insert the test strip into the meter before applying blood or control solution.
Do not touch the test strip with wet hands. Do not bend, cut, or twist the test strips.

18
Chapter 2: Control Solution Testing
When to Run a Control Solution Test
Running the EasyMax 15 Control Solution Test will let you know that your meter and test strips are working
properly. You should run control solution tests:
If you are using a new EasyMax LTC Blood Glucose Meter.
When you open a new vial of EasyMax 15 test strips.
If you think the meter or test strips may be working incorrectly.
If the meter has been dropped.
If the results are lower or higher than expected, and you have repeated the test with similar results.
When you practice the test procedure.
When your facility mandates control solution tests.

19
About Control Solution
Use only with EasyMax 15 test strips and EasyMax LTC or EasyMax NG meters.
Write the date you first open the Control Solution bottle on the label. The control solution is good for three
months from the date the bottle is opened or until the expiration date on the bottle, whichever comes first.
Do not use a control solution that is past the expiration date.
The control solution can stain clothing. If you spill it, wash your clothes with soap and water.
Close the bottle tightly after every use.
Left over control solution should not be returned to the control solution bottle.
Store the bottle of control solution at room temperature, between 36°F - 86°F (2°C- 30°C). Do not freeze.

20
Running a Control Solution Test
You need the meter, a test strip, and control solution.
1. Put a test strip into the meter in
the direction of the arrow. If the
medical record function is on, it
does not matter which number
you select because once it is
flagged as control solution, it will
not be attached to that number.
3. Place the meter on a flat
surface, like a table.
4. Remove the control solution
bottle cap and wipe the tip
of the bottle with a tissue.
5. Squeeze the bottle until a
tiny drop forms at the tip of
the bottle and place solution
on top of bottle cap.
2. Press (Left button) to select
the mode of Control Solution,
and the icon of flashes.
Note: If the Patient Medical Record is on, it does not matter which record number you select if you
flag the result as a control solution test. The result will be displayed in the meter’s memory as
a control solution test.