NuvoMed MBG10-6 Blood Glucose Monitor Instruction Manual

NuvoMed MBG10-6 Blood Glucose Monitor

KNOW YOUR DEVICE
Principle of Operation
Testing with the Blood Glucose Monitoring is based on the measurement of electrical currents generated by the reaction of glucose with the reagent of the strip. The blood glucose monitoring system measures the current and converts it to the corresponding blood glucose level. The strength of the current produced by the reaction depends on the amount of glucose in the blood sample.
Intended use of the equipment
This device is intended to be used for:

• Quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertip, palm, forearm, upper arm, calf, or thigh.
•  Single person measurement only (it should not be shared)
• Self-testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control.

This device should not be used for the diagnosis of or screening for diabetes, or for neonatal use. Alternative Site Testing (AST) should be done only during steady state times when glucose levels are not changing rapidly.
The Blood Glucose Test Strips (NGS50-24/0726) are intended for use with the Blood Glucose Monitor (MBG10-6/0741) to quantitatively measure glucose in fresh capillary whole blood samples drawn from the fingertips, palm, forearm, upper arm, calf or thigh.
MEDICAL DISCLAIMER: This device and manual are not meant to be a substitute for advice provided by doctors or other medical professionals.
Contact your physician for interpretation of measurements, or if you have or suspect you have a medical issue.
Limitation of Use

•  The Blood Glucose Monitor is not intended for use on neonates.
•  The Blood Glucose Monitor is not intended for use on artery blood, serum, plasma and venous blood samples.
• The Blood Glucose Monitor should be only used with the test strips (NGS50-24/0726).
• The Blood Glucose Monitor cannot be used above an altitude of 10744 feet (3275 meters)
• If you are taking acetaminophen containing drugs (Tylenol and other medicines containing acetaminophen, blood concentrations >5 mg/dL) or Vitamin C (ascorbic acid, blood concentrations >4 mg/dL) at doses higher than recommended, these may interfere with your glucose monitor and cause you to get inaccurate results with this system
•  Not for use for patients in a hyperglycemic-hyperosmolar state, with or without ketosis.
• Not for use on critically ill patients.
• Not to be used for patients who are dehydrated, hypertensive, hypotensive, or in shock.
•  Do not use during or soon after xylose absorption testing.

Important Safety Information and Precautions

• Misuse of the blood glucose monitoring system can cause electrocution, burns, fire, and other hazards.
• The glucose monitor and lancing device are for single patient use. Do not use either item on multiple patients.
• Do not share the monitor or lancing device with anyone, including other family members.
• Do not place the blood glucose monitoring system in or near liquid.
• Use the blood glucose monitoring system only for the purpose described in the Owner’s Manual.
• Use only accessories that are supplied by the manufacturer.
• Do not use the blood glucose monitoring system if it has sustained any damage or is not working properly.
• Do not block test ports or place the blood glucose monitoring system on soft surfaces that may block them. Keep test ports free from lint, hair, debris, etc.
• Do not place anything on top of the blood glucose monitoring system.
• Do not place foreign objects into any opening in the blood glucose monitoring system.
•  Do not use the monitor in a manner not specified by the manufacturer.
•  All parts of the system are considered biohazards and can potentially transmit infectious diseases, even after you have performed cleaning and disinfection.
•  Refer to the resources identified below for detailed information:

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](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://w[ww.cdc.gov](https://ww.cdc.gov)/injectionsafety/Fingerstick- DevicesBGM.html

Battery Warning

•  Do not mix alkaline, stand (carbon-zinc) and rechargeable batteries (nickel hydride).
•  Do not mix old and new batteries.
• Non-rechargeable batteries are not to be recharged.
• Rechargeable batteries are to be removed from the unit being charged (if removable).
• Rechargeable batteries are only to be charged under adult supervision (if removable).
•  Exhausted batteries are to be removed.
• The supply terminals are not to be short-circuited.
• Only batteries of the same or equivalent type as recommended are to be used.
• Batteries are to be inserted with the correct polarity.

PACKAGE CONTENTS

• Blood Glucose Meter
•  10 Test Strips and 10 Lancets
•  Storage Case and Log Book
• Lancet Device
• Instruction Manual

PARTS OF MONITOR

will

not be stored in the memory

Measurement Unit| Appears with the test result either in mg/dL or mmol/L
Low Battery| Appears when battery is low
Alarm Clock| 4 Memories for Alarm
Blood Sample| Flashes when it is ready to apply the sample
SET Button| Long press to turn on the monitor and set the parameter
MEM Button| Long press to turn on the monitor and view past test results
Eject Button| Remove the test strip automatically

PARTS OF TEST STRIPS
Use only the test strips (NGS50-24/0726) with (MBG10-6/0741). Each strip can be used only once.

PREPARATIACON

Before Use

• Severe dehydration and excessive water loss may cause inaccurate results. If you believe you are suffering from severe dehydration, consult your healthcare professional immediately.
• Inaccurate results may occur in severely hypotensive individuals or patients who are in shock. Test results that are lower than actual values may occur in individuals who are in a hyperglycemic-hyperosmolar state, with or without ketosis. Critically ill patients should not be tested with blood glucose monitor.
• If you think your blood glucose results are inconsistent with your feeling or symptoms which you are experiencing, repeat the test first. If you have symptoms or continue to get similar results, follow the treatment advice of your healthcare professional.
• If you are experiencing symptoms that are inconsistent with your blood glucose test, and you have followed all of the instructions provided in this Owner’s Manual, contact your healthcare professional immediately.
• Use only fresh whole blood samples to test your blood glucose.
•  Do not use test strips that are expired or appear to be damaged as they may return inaccurate results.
•  The lancing device is for self-use only. Do not share or re-use lancets. Please refer to the Lancing Device Manual for the detailed procedur

Battery Installation

1.  Open the battery compartment at the back of device.
2.  Insert 2 AAA batteries according to the +/- markings.
3.  Re-attach the battery cover back, ensuring it clicks into place.
   NOTE : When the low battery symbol appears on screen, turn off this device and follow the instructions above to replace batteries.
   CAUTION: Never leave any low battery in the battery compartment as it may leak and cause damage to this device.
   Setting the Monitor
   Before using this device for the first time or if you change the battery, you should check and update these settings.
   Make sure you complete the steps below and have your desired settings saved..

When the year flashing, press M until the correct year appears. Press S to confirm.
When the month flashing, press M until the correct month appears. Press S to confirm.
When the day flashing, Press M until the correct day appears. Press S.

When the hour flashing, Press M until the correct hour appears. Press S to confirm.
When the minute flashing, Press M until the correct minute appears. Press S to confirm.
Press M to select the unit of measurement. The unit of measurement will be preset to mg/dL before being sold to the U.S.A. Press S to confirm

PREPARATION

.Delete Memory.

At the time of your alarm setting, the monitor will beep and automatically turn on.
If you do not want to test at this time, press S again and again can skip setting alarms and screen will finally off. If you do not press S, the monitor will switch off after 2 minutes

Instruction for use

Before Taking Test for Blood Glucose
To reduce the chance of infection:

• Choose a clean, dry work surface.
•  Never share a lancing device or lancet with other person.
•  Always use a new and sterile lancet.
•  Always use a new test strip. the test strip is for single use only.
•  Avoid getting lotion, oils, dirt, or debris in or on the lancet and lancing device.

A sample may be obtained from the finger by the following steps:

1.  Wash your hands all the time, before the following steps.
2.  Insert the test strip into the monitor’s strip port with the contact bars facing toward you. The monitor and Blood Sample Symbol will display (see below).

Prepare the lancing device.

Instruction for use

1. Obtain a blood sample

Press the lancing device against the site to be lanced. Press the release button to puncture the site. Squeeze your finger until a drop of blood forms. Wipe away the first blood drop and squeeze until a second small blood drops forms.

•  Apply the blood sample to the test strip
  Quickly apply the blood sample to the absorbent hole of the test strip. Make sure the confirmation window of the test strip is completely filled with the blood sample. Quickly remove your finger from the test strip when the countdown (from 5 to 1) begins on the monitor display.

•  Test result will appear on the monitor

Note: The results obtained from the glucose monitor are plasma- calibrated. This helps you and your physician or other qualified healthcare providers to compare your monitor results with laboratory tests. Refer to the instructions given by your physician or other qualified healthcare providers, do not deviate from these instructions on the basis of the result without first consulting your physician.

• Discard the used test strip and lancet. Remove the used test strip from the monitor using a small amount of tissue paper. Discard the used test strip and lancet properly. (Tips: Prior to disposal, stick the lancet into the cover.)

About color bar

About the Color Bars
On the panel of the Blood Glucose Monitor (MBG10-6/0741), there is a color bar. It is used for indicating blood glucose value range. The Color Bar’s image is showing in picture (c) as below.
The flashing black block means the present blood glucose value range which is listed as the following table

• | Value of Blood Glucose

(mg/dL)

| Block in Color Bar
---|---|---
<70| Orange Block
70≤N<110| Blue Block
110≤N<126
126≤N<140| Purple Block
140≤N<200
≥200

Reviewing Saved Result on the Monitor

Day Average Result

•  Long press the MEM button for 3 seconds to view the test results stored in the monitor. The first reading is your recent 7-day average blood glucose result.
• Press MEM button to review 7-,14-, 21-, 28-, 60- and 90- day average results stored in the monitor.

Reviewing Test Result

• After review 90-day average results ,keep to press MEM button again, and the first reading you see is the last blood glucose result along with date, time.
• Press M to recall the test results stored in the monitor each time you press.

Note : When the memory is full, the oldest result is dropped and the newest result is added.

Exit the Memory Mode
When reaching the last test result. “End” will display, and the monitor will turn off automatically.

Instruction for use

PHYSICAL AND PERFORMANCE DETERIORATION
If you start experience one of the following, Stop using and contact local customer services or the place of purchase for assistance.

1. . The device does not work.
2. .Discoloration of the monitor casing or lancing device; for example, it is difficult to read the labeling information.
3. Corrosion, crazing (fine cracks), embrittlement, and/or cracking of the monitor casing or lancing device.

ALTERNATIVE SITE TESTING (AST)
What Is Alternate Site Testing?
Alternative site testing (AST) is the use of parts of the body, other than the fingertips, to check blood glucose levels. The Glucose Monitoring System allows you to test on the palm, forearm, upper arm, calf, or thigh with equivalent results to fingertip testing when used at appropriate times.
There are limitations for doing AST. Please consult your healthcare professional before you conduct AST. The Glucose Monitoring System should only be used for AST under steady-state blood glucose conditions.
What Is the Advantage of Alternative Site Testing?
Pain is felt more readily on the fingertips because they are full of nerve endings (receptors). At other body sites where nerve endings are not so condensed, pain is not felt as acutely.

When Should You Use Alternative Site Testing?
Food, medication, illness, stress, and exercise can affect blood glucose levels. Capillary blood from the fingertips reflects these changes faster than capillary blood from other sites. Therefore, when testing blood glucose levels during or immediately after meals exercise, or when another of the above-noted conditions applies, take a blood sample from your fingertips only. AST should be used only during steady–state times when glucose levels is not changing rapidly.
Blood glucose results from the forearm, upper arm, hand, thigh and calf are not always the same as results from fingertips. Alternative Site Testing is suitable in the following instances:

•  In a pre-meal or fasting state (two hours or more after the last meal)

•  Two hours or more after taking insulin

• Two hours or more after exercising
  Caution: Do not use sites other than fingertips for testing when blood glucose is rapidly rising or falling, within 2 hours of eating, after taking insulin, immediately after exercise, or when you are ill or under stress. Alternative Site Testing should not be used to calibrate continuous glucose monitoring systems (CGMs). Results from Alternative Site Testing should not be used in insulin dose calculations. Do not use AST if:

• You think your blood glucose is low

• You are unaware that you might have hypoglycemia

•  You are testing for hyperglycemia

•  Your AST results do not match the way you feel

•  Your routine glucose results fluctuate often

Care and Mantainence

Compare Glucose Monitor Test Result with Laboratory Results
The results obtained from the glucose monitor are plasma-calibrated. The result you obtain from your glucose monitor may differ somewhat from your laboratory results due to normal variation. Monitor results can be affected by factors and conditions that do not affect laboratory results in the same way. To make an accurate comparison between monitor and laboratory results, follow the guidelines below. Before the Lab Test

•  If possible, fast at least eight hours before conducting a comparison test.

•  Take your monitor to the lab.
  While at the Lab
  Make sure that samples for both tests are taken and tested within 15 minutes of each other.

•  Wash your hands before obtaining a blood sample.

• Never use your glucose monitor with blood samples collected in a test tube.

•  Use fresh capillary blood only.

CARE AND MAINTENANCE

•  For regular maintenance, this device only needs to be wiped gently with a soft, dry cloth. Never immerse this device or any components in water.
•  Do not carry out repairs of any kind yourself. If a defect occurs, please contact your local authorized distributor. Use only authorized parts and accessories.
•  The cleaning and disinfection is absolutely necessary for the test procedure, because cleaning can insure the monitor works well (for example, display will be clear to see after cleaning); and disinfection can avoid the infection to you or to the other people, and the cross-infection.
• The monitor and lancing device should be cleaned and disinfected following each use.
•  The monitor and the lancing device are for single-patient use, if user test 6 times every day, the monitor and lancing device should be cleaned and disinfected 6 times per day which equals to 10950 number of cycles over the 5 year life of the devices. The monitor and lancing device were validated for 11,000 cycles which could support up to 6 cleaning and disinfection cycles per day.
•  Below are the steps on how to clean and disinfect the monitor and lancing device.

1.  After a test, clean and wash your hands.
2.  Use wipes carefully to clean the entire external surface of the monitor.
3.  Then wipe the entire external surface of the monitor with another wipe, keep the surface wet for 2min.
4. Use the same method with the wipes to clean and disinfect the lancing device.

Note:

• Wash hands thoroughly with soap and water after handling the monitor, lancing device, or test strips.
• .Only the surface of the monitor can be cleaned and disinfected with the disinfecting towelette. Do not insert the disinfecting towelette into the test strip port and the metal connector, or else the performance of the monitor may be affected.
• .If you have any questions you can call your local customer service.
• .If the monitor is being operated by a second person who is providing testing assistance to the user, the monitor and lancing device should be cleaned and disinfected prior to use by the second person.

Units of Measure

Troubleshooting

If you follow the recommended action but the problem persists, or error messages other than the ones below appear, please call your local customer service. Do not attempt to repair the monitor by yourself and never try to disassemble the monitor under any circumstances.
Display Messages

• __

| Blood glucose level is lower than 20mg/dL (1.1mmol/L).| The message indicates very low blood glucose. Consult with your healthcare professional.

• __

| Blood       glucose        level        is       higher than600mg/dL (33.3mmol/L).| The message indicates severe hyperglycemia (high blood glucose). Seek immediate medical assistance.

• __

| The battery in your monitor in low on power.| Please change the battery.

• __

| Problem with the monitor.| Re-test with a new test strip.

• | Problems have occurred that are related to test strip use, such as:

–     test strip may be wet or damaged

–     test strip may be removed too early

–     you applied more blood after testing began

| Retest using a new test strip.

• | The environmental temperature is lower than 50℉ (10℃).| The operating temperature is 50°F

~ 104°F (10°C ~ 40°C)

• | The environmental temperature is higher than 104℉（40℃）.| The operating temperature is 50°F

～104°F (10°C ~ 40°C)

Troubleshooting

Display remains blank after the test strip has been inserted into the monitor.| 1.  Battery power is too low for use.

2.  Too much time has passed between inserting the test strip  and performing the test.

3.  Test strip has not been fully

inserted into the monitor.

| 1.  Please change the battery.

__

2.  Reinsert the test strip into the monitor.

__

__

3.  Reinsert the test strip into the monitor, pressing firmly.

Test results are inconsistent.| 1.  Not enough sample in the test strip.

__

2.  Test strip has expired.

3.  Test strip has been damaged due to heat or humidity so that the sample cannot be applied, or the speed of application is too slow.

4.  System is not performing due to the environment being above or below room temperature.

| 1. Re-test with a new test strip and make sure that enough sample has been applied.

2.  Re-test with a new test strip.

3. Replace with new vial of test strips.

__

__

__

4. Bring the system to a room- temperature environment and wait approximately 30 minutes before performing a

new test.

The monitor countdown did

not start.

| Test  strip  has  not  been

inserted correctly.

| Use a new test strip and redo

the test.

EMC Declaration

ELECTROMAGACNETACIC COMPATIBILITY INFORMATION

Guidance and manufacture’s declaration – electromagnetic emissions

This device is intended for use in the electromagnetic environment specified below.

The customer or the user of this device should assure that it is used in such an environment.

Emissions test| Compliance| Electromagnetic environment – guidance
RF emissions CISPR 11| Group 1| This device uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby

electronic equipment.

RF emissions CISPR 11| Class B| This device is suitable for use in all establishments, including domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.
Harmonic emissions IEC 61000-3-2| Class A
Voltage fluctuations/ flicker emissions

IEC 61000-3-3

| Complies
Guidance and manufacturer’s declaration – electromagnetic immunity
This device is intended for use in the electromagnetic environment specified below. The

customer or the user of this device should assure that it is used in such an environment.

Immunity Test| IEC 60601 Test

level

| Compliance level| Electromagnetic environment –

guidance

Electrostatic discharge (ESD) IEC61000-4-2| ± 6 kV contact

± 8 kV air

| ± 6 kV contact

± 8 kV air

| Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30 %.
Power frequency (50/60 Hz) magnetic field IEC61000-4-8| 3 A/m| 3 A/m| Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment.
NOTE: UT is the a.c. mains voltage prior to application of the test level.

EMC Declaration

Guidance and manufacturer’s declaration – electromagnetic immunity

This device is intended for use in the electromagnetic environment specified below. The customer

or the user of this device should assure that it is used in such an environment.

Immunity Test| IEC 60601 Test

Level

| Compliance

Level

| Electromagnetic environment – guidance
| | | Portable and mobile RF communications equipment should be used no closer to any part of this device, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter.

Recommended separation distance ：

| | | d = 1.2       80 MHz to 800 MHz

Radiated RF IEC 61000-4-3

|

3 V/m 80 MHz

to 2,5 GHz

|

3 V/m

| d = 2.3   800 MHz to 2,5 GHz

Where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in meters (m).

Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey,a should be less than the compliance level in each frequency range.b

Interference may occur in the vicinity of equipment marked with the following symbol:

| | |
NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies.

NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected

by absorption and reflection from structures, objects and people.

•   Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which this device is used exceeds the applicable RF compliance level above, this device should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating this device.
•    Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3V/m.

EMC Declaration

Table 3 For ME EQUIPMENT and ME SYSTEMS that are not LIFE-SUPPORTING

Recommended separation distances betweenbportable and mobile RF communications equipment and this device

This device is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of this device can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and this device as recommended below, according to the maximum output power of the communications equipment.
Rated| Separation distance according to frequency of transmitter
maximum| (m)
output| 150 kHz to 80 MHz| 80 MHz to 800 MHz| 800 MHz to 2,5 GHz
power of| d = 1.2| d = 1.2| d = 2.3
transmitter| | |
W| | |
0,01| 0,12| 0,12| 0,23
0,1| 0,38| 0,38| 0,73
1| 1,2| 1,2| 2,3
10| 3,8| 3,8| 7,3
100| 12| 12| 23
For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be determined using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer.

NOTE 1: At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies. NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.

FCC Compliancw

References

• NuvoMed – Healthy Living Made Simple
• NuvoMed – Healthy Living Made Simple

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