Empecs Medical Device Medisign MM1100 BT User Manual

Read this User Manual carefully before you start the test and do a quality
control test. If you have any questions about the control test consult with your
healthcare professional. Confirm the measuring unit on the display is correct
with ever test result.

Call Customer Service Toll-Free
24 hours a day, 7 days a week
1-888-885-6677
or visit our website

Manufactured by:
Tianjin Empecs Medical Device Co.,Ltd.
No.35 and 37, Yingcheng Street, Hangu,
Binhai New Area, 300480 Tianjin China

www.empecs.com

Medisign MM1100 BT

Blood Glucose Monitoring System

User Manual

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Sign of Trouble

If you are experiencing any of the issues below, call customer service at
1-888-885-6677.

lThe meter doesn't power on when the new test strip is inserted into the meter.
lThe meter doesn't power on when you replace the batteries.
lThe meter doesn't show the test result after the test is completed.
lThe LCD does not display correctly or is distorted after changing the batteries.

If you encounter any issues including the ones mentioned above, call
customer service at 1-888-885-6677.

Important Safety Instruction

lBlood glucose meters are at high risk of contamination with blood-borne pathogens

such as Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), and Human
Immunodeficiency Virus (HIV).Transmission of these viruses from user to user has been
documented due to contaminated blood glucose devices. Accordingly, cleaning
and disinfecting meters between users can prevent the transmission of these viruses
through indirect contact.

lThe 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.

lAll parts of the kit are considered as biohazards. The system may transmit infectious

diseases, even after it has been cleaned or disinfected.

lIf the meter is being operated by a second person who is providing testing assistance

to the user, the meter and lancing device should be disinfected prior to use by the
second person.

lReferences

1. FDA Public Health Notification: Use of Fingerstick Devices on More than One Person
Poses Risk for Transmitting Blood Pathogens:Initial Communication (2010)
http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm224025.htm

2. CDC Clinical Reminder: Use of Fingerstick Devices on More than One Person Poses a
Risk for Transmitting Blood-borne Pathogens (2010)
http://www.cdc.gov/injectionsafety/Fingerstick-DevicesBGM.html

Contents

nAbout Your New System

Welcome
Intended Use
Application
Test Principle
Special Features
Usage and storage
Important Information
System Components

nTesting Your Blood Glucose

Disinfection Before test
Performing a Blood Glucose Test
Flagging Test Results
Handling the Used Test Strips

Alternate Site Testing (AST)

nMeter Setup, Memory and Downloading

Setting up Your Meter

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Reviewing Test Results
Downloading Test Results to a PC

nPairing Your Meter

How to Pair Your Meter

nControl Test

Performing a Control Test

Understanding Control Test Results

nMaintenance and Troubleshooting

Cleaning and Disinfecting
Replacing the Batteries
Screen Messages
Troubleshooting

nTechnical Information and Warranty

Specifications
Warranty
Disposing of your Meter
Additional Supplies Available

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0201

About Your New System

Welcome

Thank you for selecting the Medisign MM1100 BT Blood Glucose Monitoring
System. This user manual is designed to provide you with information on how to
use the Medisign MM1100 BT Glucose Monitoring System. Follow the instructions
carefully that are detailed in this manual. Before using your monitoring system
for the first time, please read this manual carefully and If you have any
questions, contact Customer Service at 1-888-885-6677, anytime-24 hours a
day. You can also obtain information at www.empecs.com.

Intended Use

Medisign MM1100 BT Blood Glucose Monitoring System is intended for the
quantitative measurement of the glucose in fresh capillary whole blood drawn
from fingertip, palm, and forearm by a single patient (lay user) as an aid in the
management of diabetes. It is intended for self testing by persons at home, for
single patient use only, and should not be shared.

It is intended for use outside the body (in-vitro diagnostic use only) and not for
the diagnosis of or screening of diabetes or for neonatal use.
The alternative site testing (palm and forearm) should be done only during
steady state times (when glucose in not changing rapidly).

Application

Medisign MM1100 Blood Glucose Test Strips are for in-vitro diagnostic use and
for self testing only. The Medisign MM1100 BT Blood Glucose Meter is not a
substitute for your physician or Healthcare Professional. Use the Medisign
MM1100 BT Blood Glucose Meter in conjunction with your Healthcare Program.

Test Principle

Glucose in the blood sample reacts with glucose oxidase on the test strip and a
harmless electrical current is produced. The strength of these currents change
with the amount of glucose in the blood sample and the Medisign MM1100 BT
Blood Glucose Meter automatically interprets this reaction.

03 04

Glucose measurements are reported as plasma equivalents. This system uses
plasma equivalent methodology. Results that use a plasma equivalent method
are approximately 11% higher than those obtained with whole-blood
equivalent test strips.

Special Features

lAccurate result in 5 seconds using only 0.5㎕ blood sample.
lThe Medisign MM1100 BT Glucose Meter identifies the test strip code

automatically.

lStores up to 300 test results.
lBlood glucose measurement units are pre-set in mg/dL.

Usage and Storage

lBefore using your monitoring system, please place it in the environment of the

system's normal operating temperature range of 50-104 ℉ for about
twenty (20) minutes.

lDo not allow dirt or dust into the test strip port in order to avoid affecting the

monitoring system's accuracy.

lDo not attempt to repair or alter your monitoring system.
lDo not put the monitoring system near any electromagnetic field. (e.g. TV,

microwave oven, mobile phone)

lHandle your monitoring system with care.
lKeep away from direct sunlight and humid conditions.
lPlease use a soft cotton cloth to wipe the system.
lDo not use a corrosive product (e.g. Benzene, Acetone) to clean your

monitoring system.

05 06

Important Information

lMake sure to use your test strip immediately after retrieving it from the vial,

be sure to keep the test strip vial closed tightly at all times.

lFor the most accurate results, make sure your hands are clean and dry

before removing the test strips from their vial.

lDo not touch test strip slit.
lDo not use test strips that have expired, using expired test strips may cause

inaccurate test results.

lNever reuse a test strip that has had either blood or control solution

applied. The Medisign MM1100 Test Strip is for single use only.

lThis product is not recommended for pregnant women, newborns or if you

are severely dehydrated.

lBefore the test you must make sure that the code number displayed on

the meter matches the code number on the test strip vial.

lKeep your Medisign MM1100 BT Blood Glucose Meter, lancing device,

lancets and control solutions out of reach of children or pets.

lBe sure to check the glucose measurement unit on the meter before the

test.

- This meter is preset to mg/dL.

- mg/dL is the unit of measurement used in the US.

lMake sure you close the test strip vial is closed tightly and store at indoor

area between 39 ~ 86℉,10~90%RH. Do not freeze.

lKeep test strips away from direct sunlight and heat.
lUse this system only for blood glucose test.

l

℉

Before using the Medisign MM1100 BT Blood Glucose Monitoring System,
please read this manual carefully.

lThe meter and test strips should be handled at the same temperature.
lFor accurate test results, keep the Medisign MM1100 BT Blood Glucose

Monitoring System operating temperature at a range between 50-104 for
more than twenty (20) minutes before testing.

07 08

lDo not use any anticoagulants or preservatives other than heparin when

collecting capillary blood into test tubes.

lBe sure to clean and disinfect your Medisign MM1100 BT Blood Glucose

Meter regularly.

lDo not reuse the test strips, test strips are single use only.
lYou may use this system at altitude up to 10,000 feet.
lClean and disinfect your Medisign MM1100 BT Blood Glucose Meter at

least once per week.

Inaccurate results may occur for individuals or patient in shock.
Inaccurate results may occur for individuals experiencing a
hyperglycemic-hypersmolar state with or without ketosis. Critically ill
patients should not be tested with this blood glucose meter.
Interferences: Acetaminophen, salicylates, uric acid, ascorbic acid
(vitamin C) and other interferent substances in normal blood or normal
therapeutic concentrations do not significantly affect results, however
abnormally high concentrations in blood may cause inaccurate results.

lThe Medisign MM1100 BT Blood Glucose Monitoring System is for testing

outside of the body (in-vitro diagnostic use).

l

l

l

CAUTION: Use only Medisign MM1100 Test Strips with your Medisign MM1100
and Medisign MM1100 BT Blood Glucose Meters.

l Testing under out of the specification range may cause inaccurate results.
l Patients undergoing oxygen therapy may yield false low results.
l Lipemic samples (triglycerides) in excess of 1,500 mg/dL may produce

elevated results.

l Hematocrit is the percentage of red blood cells in the blood. HCT levels of

30-55% do not affect glucose measurements with this meter. If you do not
know your hematocrit level, consult with your healthcare professional.

l This test strip is not for use with arterial, venous, neonatal, serum or plasma

samples.

l Testing out of HCT level range of (30~55%) and recommended storage

conditions may cause inaccurate results.

lDispose of used test strips and lancets according to instructions from your

healthcare provider.

09 10

Medisign MM1100 BT Blood Glucose Meter

The Complete Medisign MM1100 BT
Blood Glucose Monitoring System

The Medisign MM1100 BT Blood Glucose Monitoring System includes the
Medisign MM1100 BT Meter, Ten(10) Medisign MM1100 Test Strip, Lancing
Device, Lancets, Carrying Bag, User Manual, Warranty Card, (2) 3.0 Volt CR2032
Lithium Batteries and Logbook.

Medisign MM1100 test strips and Medisign Glucose Control Solution can be
provided by contacting your supplier, or for additional information you can
contact Customer Support at 1-888-885-6677.

Display

'M' Bu tt on

'C' Bu tt on

Test Strip port

Serial port

Battery Lid

Label

Test Strip Ejector

11 12

Explanation of Display

Medisign MM1100 Blood Glucose Test Strip

lUse Medisign MM1100 Blood Glucose Test Strips with the Medisign MM1100

and Medisign MM1100 BT Blood Glucose Meter.

lCheck the expiration date of your test strips before using.
lWrite the opening date of the new test strip vial in order to avoid using any

expired products.

Lot Nu mb er

Expi ra ti on Date

Samp le
Chan ne l

Test Strip Vial Medisign MM1100 Blood Glucose Test Strip

A

B

Low Battery Warning

Stored Test Results
Test Results

Unit of Measurement

Temperature Error
No Beep

Pre meal / Post meal Mark

Ready to Test
Control Solution

Average Result
Month / Date

Time

Bluetooth (wireless RF on)

b

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7. Adjust the puncture depth setting if necessary by turning the lancing device
cap, number 1 is the shallowest depth while number 5 is the deepest. Slide
the ejection/cocking control barrel back until it clicks. If it does not click, the
lancing device may have been cocked when the lancet was inserted.

8. Hold the lancing device firmly against your finger. Press the release button.

9. Gently squeeze your finger to assist the flow of blood. Do not squeeze
excessively on the puncture site.

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8

9

4. Insert a test strip to turn on the meter. Make sure it is inserted completely
without bending the test strip.

5. The meter identifies the code number automatically. Compare the code
number displayed on the LCD with the code number shown on the test strip
vial. If they do not match try again with an another test strip. If the problem
persists contact customer support at 1-888-885-6677.

6. When the blood symbol appears, you can proceed with your test.

64 5

A01

13 14

Performing a Blood Glucose Test

1. Remove your lancing device cap.

2. Install the new lancet into your lancing device.

3. Remove the protective cap from the lancet. Replace the lancing device
cap.

NOTICE: Refer to the lancing device instruction for additional detailed

information. The lancing device instruction depicted in this manual is for most
universal lancing devices.

1 2 3

Testing Your Blood Glucose

Disinfect Before Testing

lBefore testing, wash your hands with soap and water and dry thoroughly.
lUse an alcohol prep pad to wipe the area before testing.
lWait until the alcohol dries completely.

17 18

10. Hold the tip of the test strip to the drop of blood, the test strip will
automatically draw the blood into the test strip. When the test strip has
enough blood the meter will beep and count down from five seconds. After
five seconds your test result will appear.

NOTICE: When the blood sample is not sufficient, the display screen will show
the message of "Er 4"(Please refer to error messages in this manual.)

CAUTION:

lDo not drop the blood directly on the end of the test strip.
lThe sample channel at the end of the test strip should show full. When you

hear the beep sound, you have enough blood in the test strip.

lInaccurate results may occur for individuals or patient in shock.

Inaccurate results may occur for individuals experiencing a
hyperglycemic-hypersmolar state, with or without ketosis. Critically ill
patients should not be tested with a blood glucose meter.

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