Easy-Touch HealthPro User Manual

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Call 877.358.4342
MHC Medical Products, LLC
8695 Seward Road
Faireld, Ohio 45240
TE-081313.8
User Manual
Important Information
Thank you for choosing the EasyTouch® HealthPro™ Glucose Monitoring System. This manual contains everything you need to know about your new glucose meter and how it works. Please take a moment to read the instructions carefully.
The EasyTouch® HealthPro™ Glucose Monitoring System oers a fast, accurate, and convenient way to read your glucose levels. The meter has been designed to automatically turn on when the test strip is inserted into the meter, automatically code the meter to the strip, and automatically turn o after the reading. Please take a moment to read this manual to learn of more convenient features to help you manage your diabetes. After doing so, we hope you will agree, the EasyTouch® HealthPro™ Glucose Monitoring System is designed to oer a better user experience.
Always consult with your healthcare professional before making any changes to your diabetes management. The EasyTouch® HealthPro™ Glucose Monitoring System is for in-vitro diagnostic use only. MHC Customer Service is available toll free at (877) 358-4342, Monday thru Friday, 9am to 5pm EST.
Intended Use
The EasyTouch® HealthPro™ Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary blood samples drawn from the ngertips, ventral palm, dorsal hand, upper arm, forearm, calf and/or thigh. The EasyTouch® HealthPro™ Glucose Monitoring System is intended to be used by a single patient and should not be shared.
The EasyTouch® HealthPro™ Glucose Monitoring System is intended for self-testing by people with diabetes at home and on the go, and also for healthcare professionals in a clinical setting. The EasyTouch® HealthPro™ Glucose Monitoring System should not be used for the diagnosis of or screening of diabetes or for neonatal use. Alternative site testing should be done only during steady–state times (when glucose is not changing rapidly).
The EasyTouch® HealthPro™ Glucose Test Strips are for use with the EasyTouch® HealthPro™ Meter to quantitatively measure glucose (sugar) in fresh capillary blood samples drawn from the ngertips, ventral palm, dorsal hand, upper arm, forearm, calf and/or thigh.
The EasyTouch® HealthPro™ Glucose Control Solutions are for use with the EasyTouch® HealthPro™ Meter and Test Strips to check that the meter and test strips are working together properly. The test also serves as a quality control to ensure the accuracy of the glucose test results.
The EasyTouch® HealthPro™ Glucose Monitoring System provides a quick and easy way for patients with diabetes to measure their blood sugar levels.
It should only be used with fresh capillary blood samples. It is designed for in-vitro diagnostics use only and should not be used for any purpose other than monitoring blood sugar levels. It should not be used for the diagnosis of diabetes or for the testing of newborns (neonates).
WARNING:
Do not change your medication based on the EasyTouch® HealthPro™ meter test results without contacting your physician or healthcare professional.
Important Safety Instructions
The Centers for Disease Control and Prevention (CDC) and the US Food and Drug Administration (FDA) have become increasingly concerned about the risks for transmitting Hepatitis B virus (HBV) and other blood born pathogens to persons undergoing nger stick procedures for blood sampling (Ex. Persons with diabetes who require assistance monitoring their blood glucose levels). Reports of HBV infection outbreaks linked to diabetes care have been increasing. This notice serves as a reminder that nger stick devices should never be used for more than one person.
WARNING:
1. The EasyTouch® HealthPro™ Meter and Lancing Device are for single patient use only. Do not share them with anyone, including other family members. Do not use on multiple patients.
2. All parts of the kit are considered bio-hazardous and can potentially transmit infectious diseases, even after you have cleaned and disinfected.
3. Always use a new sterile lancet. Lancets are for single use only.
4. Avoiding getting hand lotions, oil, dirt or debris in and/or on the lancets and lancing device.
5. Please refer to page 33 for cleaning and disinfecting the EasyTouch® HealthPro™ Glucose Monitoring System.
“FDA Public Health Notication: Use of Finger stick Devices on More than One Person Poses Risk for Transmitting Blood born Pathogens: Initial Communication Update 11/29/2010” http://www.fda.gov/medicaldevices/safety/alertsandnotices/ucm224025.htm
“CDC Clinical Reminder: Use of Finger stick Devices on More than One Person Poses Risk for Transmitting Blood born Pathogens”(2010) http://www.cdc.gov/injectionsafety/Fingerstick-DevicesBGM.html
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Table of Contents
About your New Easy•Touch® HealthPro™ Glucose Monitoring System
About Your New EasyTouch® HealthPro™
Glucose Monitoring System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
EasyTouch® HealthPro™ Kit Contents . . . . . . . . . . . . . . . . . . . . . . . . . 7
EasyTouch® HealthPro™ Meter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
EasyTouch® HealthPro™ Meter Display . . . . . . . . . . . . . . . . . . . . . . . . 9
EasyTouch® HealthPro™ Glucose Test Strip . . . . . . . . . . . . . . . . . . . . 10
Before Your Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
Comparing your Meter and Lab Results . . . . . . . . . . . . . . . . . . . . . . 12
Setting Your Meter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
Auto-coding Function . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
Backlight Function . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
Testing with the Control Solution . . . . . . . . . . . . . . . . . . . . . . . . . . 17
Performing Your Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
Performing a Blood Test with Your Fingertip . . . . . . . . . . . . . . . . . . . 20
Disposing of Your Test Strips and Lancets . . . . . . . . . . . . . . . . . . . . . 24
Reviewing your Results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
Reviewing Your Blood Sugar . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
Reviewing Your Averages . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
Deleting Individual Test Result . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26
Deleting All Test Results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26
Alternate Site Testing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27
Lancing and Sampling from an Alternate Site Area . . . . . . . . . . . . . 28
Caring for Your EasyTouch® HealthPro™ Meter . . . . . . . . . . . . . . . . 32
Cleaning and Disinfecting Procedures . . . . . . . . . . . . . . . . . . . . . 33
Storage of Your System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35
Transferring Your Results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36
Battery Installation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37
Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38
Warranty . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42
Specications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43
EasyTouch® HealthPro™ Kit Contents
The following items are included:
1. EasyTouch® HealthPro™ Meter
2. Carrying Case
3. Instruction Manual
4. Logbook
5. Two 3V Coin Batteries, CR2032
Your EasyTouch® HealthPro™ Glucose Monitoring System has been sealed to protect the contents. If you nd your seal has been broken, please return it to the place of purchase.
6. 10 Twist Lancets
7. 1 Lancing Device
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Easy•Touch® HealthPro™ Meter
Easy•Touch® HealthPro™ Meter Display
Meter Diagram
Test Strip Port
Insert the EasyTouch® HealthPro™ Test Strip here.
Test Strip Ejector
For hands-free disposal of used test strips.
Display Screen
Displays your test results, symbols, and messages.
Power/Enter Button
Powers the meter on/o, prompts memory data and acts as an enter button during setup and after tests.
Up/Down Arrow Buttons
Scrolls up or down to adjust settings or to retrieve memory.
Serial Number
Battery Cover
CAUTION:
Do not use the EasyTouch® HealthPro™ Glucose Meter in an environment with humidity below 10%, especially if synthetic materials are present. Synthetic clothes, carpets, etc., may cause damaging static discharges in an arid environment.
Display Layout Symbol Bank
Low Battery Warning Symbol
Alarm Symbol
Troubleshooting Symbol
Delete Results
Average Test Result System
Before Having a Meal
After Having a Meal
After Taking Medication
After Sport Activity
Control Solution Symbol
Blood Drop Symbol for Test
Strip Code Symbol
Test Result Unit Symbol
Temperature / Date
Time / Test Result Amount
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Before You TestEasy•Touch® HealthPro™ Glucose Test Strips
Test Strip Diagram
Target to Apply Blood Sample (.5µL)
Contact Bar
Insert this End into Test Strip Port
1. Store the EasyTouch® HealthPro™ Test Strip vials in a cool, dry place. Keep out of direct sunlight. Do not freeze.
2. Store test strips in their original vial only. Do not mix the test strips in new vials or in any other container.
3. Immediately replace the vial cap and close tightly after removing any test strips from the vial.
4. Make a note of the discard date, which is three months from the date you rst open a new vial of strips. Throw the EasyTouch® HealthPro™ Test Strips and vial away after the discard date.
5. Do not use the test strips after the expiration date printed on the package or vial since it may cause inaccurate results.
6. EasyTouch® HealthPro™ test strips are for single use only. DO NOT RE-USE.
7. Do not test at temperatures below 50˚F, or above 104˚F.
8. Do not test with humidity below 10% or above 90%.
9. Do not bend, cut, or alter the test strip.
10. Avoid getting dirt, food, and/or water on the test strip.
11. Avoid getting dirt, food, and/or water on the vial label.
12. Refer to additional information in the EasyTouch® HealthPro™ Test Strip package.
Make sure to read this section and the test strip package insert found in the test strip box carefully. You will need to have all of the necessary items to begin testing:
Necessary Items:
1. EasyTouch® HealthPro™ Meter
2. EasyTouch® HealthPro™ Test Strip
3. Lancing Device
4. Sterile Lancet
If the meter is moved from one temperature to another, allow 30 minutes for the meter to adjust to the new temperature before testing. Make sure that the EasyTouch® HealthPro™ Meter and Test Strips have adjusted to the temperature of the location from where you are testing. Do not operate the EasyTouch® HealthPro™ system in direct sunlight.
CAUTION:
To reduce the chance of infection:
1. The lancing device and sterile lancets should NOT be shared with others.
2. Always use a new sterile lancet and a new glucose test strip.
3. Practice using the lancing device and become accustomed with its use.
4. Lancets and glucose test strips are for single use only.
5. Wash your hands with soap and warm water before testing.
6. Avoid getting hand lotion, oils, dirt or debris on the lancets or on the lancing device.
7. Dry your hands completely before testing.
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Setting Your MeterComparing Your Meter & Lab Results
Test results with the EasyTouch® HealthPro™ Glucose Monitoring System are plasma-equivalent. This method will help you and your healthcare professional compare your meter results with laboratory test results. The EasyTouch® HealthPro™ test results and laboratory test results both are expressed in plasma-equivalent units. However, your glucose monitor results may dier from your laboratory results due to normal variation. Your glucose monitor results can be aected by factors and conditions that do not aect laboratory results in the same way.
Your EasyTouch® HealthPro™ monitor value is considered accurate when it is within ± 20% of the laboratory measurement. There are some specic situations that could cause a difference of more than ± 20%.
1. You are severely dehydrated.
2. You have eaten recently. The blood glucose level from blood obtained from a ngertip can be up to 70mg/dL higher than blood drawn from a vein (venous sample) used for a lab test.
3. Your hematocrit is above 60% or below 20%. Sacks, D.B.: Carbohydrates: Carbohydrates: Burits, C.A. and Ashwood, E.R. (ed.), Tietz Textbook of Clinical Chemistry. Philadelphia: W.B. Saunders Company (1994), 959
If you perform a blood sugar test with the system at a temperature near the low end of the operating range, it could result in a false high blood sugar. Repeat the test in a warmer environment with a new test strip as soon as possible. For additional information on possible limitations for accuracy on precision, please refer to your test strip insert. In order to make the most accurate comparison to your laboratory results, please follow a few basic guidelines:
Before going to the Lab
Do not eat for at least two hours before you test your blood. Perform a control solution test to make sure the meter is working properly. Take your meter with you to the lab.
While at the Lab
Follow all instructions in this owner’s booklet for performing a blood sugar test with your meter. Conduct your meter test within 15 minutes of lab test. Use only fresh capillary blood obtained from the ngertip.
You may still experience a dierence from the laboratory test results because blood sugars can change very rapidly over a short period of time. This is due to a variety of reasons such as exercise, medication, stress or loss of body uids.
The EasyTouch® HealthPro™ Meter has a wide variety of functions from which to choose. From the setup mode you have the ability to turn activity/meal ags, set the date/time, designate three averages and set up to ve daily alarms.
Power On
Press for at least 3 seconds.
Date / Time
After pressing and releasing either or buttons to set the date and time, conrm each with .
User Activity Option
After pressing and releasing either or buttons to turn the User Activity Option on/o, conrm with .
Test Unit
Your meter is pre-set to mg/dL as test units. Just conrm it with . The correct units of the measurement in U.S. are mg/dL.
Year
After pressing and releasing either or buttons to set the year, conrm with .
Temperature Unit
Press and release either or buttons to set °C or °F, conrm with .
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Auto-coding FunctionSetting Your Meter, Cont.
1. The EasyTouch® HealthPro™ has an automatic code recognition function.
Days for Avg.
After pressing and releasing either or buttons to set the number of days, conrm with .
Alarm
After programming the number of desired alarms (5 alarms possible), conrm with .
IMPORTANT:
1. Your EasyTouch® HealthPro™ Meter is pre-set to mg/dL as test unit. If you nd out that the meter is not set to mg/dL, please contact MHC Customer Support at (877) 358-4342 immediately.
2. The correct units of the measurement in U.S. are mg/dL.
3. Without setting the date properly, the average glucose level and the results in memory will not show proper values. It is recommended to set the meter before use immediately after new batteries are installed.
4. You can’t test your blood glucose in the setting mode.
5. To turn the meter o during the setup, press for at least 5 seconds.
Alarm On/Off
After pressing and releasing either or buttons to turn the alarm on/o, conrm with .
Alarm Time
After pressing and releasing either or buttons to set the alarm hour and minute, conrm with .
2. The code number on the glucose meter is set automatically and should match the code on your test strip vial.
CAUTION:
1. Do not bend the glucose test strip. Bending could cause automatic code recognition failure.
2. If the code recognition label is damaged, the code recognition may fail. Please check the code number on the LCD window with the code number on the test strip.
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