GLUCORACY G-425-2 Blood Glucose Monitoring System User Manual

User Manual
G-425-2 Blood Glucose Monitoring System

Dear Glucaric Blood Glucose Monitoring System G-425-2 Owner:
Thank you for choosing this system!
This manual contains important information you must know about the system.
Please read it thoroughly and carefully.
The system provides No Code function which means that you don’t need to calibrate your meter making it easier for the user to monitor blood glucose at home.

Important safety instructions

The meter and lancing device are for single patient use.
Do not share them with anyone including other family member! 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.
Changes or modifications not expressly approved by the party responsible for compliance could void the user’s authority to operate the equipment.
Read this before using
DANGER – Misuse of this electrical device can cause electrocution, burns, fire and other HAZARDS.
Basic safety precautions should always be taken, including all those listed below.
Close supervision is necessary when equipment is used by, on, or near children, handicapped persons or invalids.
The following basic safety notices should always be taken:

1. Do not place the device in liquid, nor put it where it could fall into liquid.
2. The following basic safety notices should always be taken.
3. Use the device only for the intended use described in this manual.
4. Do not use adjunct which are not supplied by the producer.
5. Do not make the device come into contact with surfaces which are too hot to touch.
6. Do not use the device where aerosol sprays are being used.
7. Do not use the device if it is not working properly, or if it has been damaged.
8. Read all the manuals, and practice the test, and then use the product to test your blood glucose. Do all quality control checks as directed and consult with a diabetes expert.

KEEP THESE INSTRUCTIONS IN A SAFE PLACE
Limitations of use:
►The Blood Glucose Monitoring System is not intended for use on neonates.
►The Blood Glucose Monitoring System is not intended for use on artery blood, neonates’ serum and plasma.
►The system can be used up to an altitude of 10744 feet.
►The following substances at levels greater than normal or therapeutic levels may cause significant interference (affect the result by greater than 10%) resulting in an inaccurate result: ascorbic acid, uric acid, hemoglobin， acetaminophen, Dopamine, L-dopa and Tolbutamide etc. These sub- stances do not affect test results in normal concentration but may affect test results in high concentration. Do not use haemolysis sample, icterus sample or high lipemia samples.
►Patients undergoing oxygen therapy may yield falsely lower results.
►Not used 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.
►Very low (less than 20%) or very high (more than 60%) red blood cell count (hematocrit) can lead to incorrect test results. If you do not know your hematocrit level, please consult your health care provider.
►High temperature (more than 104°F) and low temperature (less than 50°F) may lead to incorrect test results.
►High humidity (more than 85%) and low humidity (less than 10%) may lead to incorrect test results.

Before Your Begin

Installing the battery

1. Open the battery cover on the back of meter.
2. If replacing the batteries, please remove the used batteries.
3. Insert 2 new (AAA) batteries with correct +/- direction.
4. Close the battery cover.

**** Environment Protection – Waste electrical products should not be disposed of with household waste. Please recycle where facilities exist. Check with your local Authority or retailer for recycling advice.

INTRODUCTION TO THE SYSTEM ABOUT YOUR SYSTEM

Intended Use

• The Glucaric Blood Glucose Monitoring System is comprised of Glucaric Blood Glucose Meter and Glucaric Blood Glucose Test Strips.
• The Glucaric Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip. The Glucaric Blood Glucose Monitoring System is intended to be used by a single person and should not be shared. It is intended for 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. The Glucoracy Blood Glucose Monitoring System should not be used for the diagnosis of or screening for diabetes. The Glucaric Blood Glucose Monitoring System is not for use in neonates.

Warnings

• The System is intended for use outside the body (in vitro diagnostic use). It is for single-patient use. It should be used only for testing glucose (sugar) and only with fresh capillary whole blood samples taken from the finger. The system is intended for use at home. It should not be used for the diagnosis of diabetes or for the testing of newborns.

• The System is intended for 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. Alternative site testing should be done only during steady
  – state times (when glucose is not changing rapidly).

• The blood glucose test strips are for use with the Blood Glucose Meter to quantitatively measure glucose in fresh capillary whole blood samples drawn from the fingertips.

• This device is not intended for use in healthcare or assisted-use settings such as hospitals, physician’s offices, or long-term care facilities because it has not been determined to be safe and effective for use in these settings, including for routine assisted testing or as part of glycemic control procedures.

• Use of this device on multiple patients may lead to transmission of Human Immunodeficiency Virus (HIV), Hepatitis C Virus (HCV), Hepatitis B Virus (HBV), or other bloodborne pathogens.

• When the following phenomenon happens, the user should stop using meter and contact customer service:
  -The test result of control solution exceeds the range of vial labeled.
  -The meter fails to display relative information;
  -The meter does not respond when inserted test strips;
  -The meter damaged severely (eg. Broken case, screen chalkboard)

Test principle

The System uses electrochemical methodologies. The System quantitatively measures blood glucose levels using an Amperometry method. The method involves detecting the current produced from glucose oxidation. The strength of the current produced by the
reaction depends on the amount of glucose in the blood sample. The electrons generated during this reaction are transferred from the blood to the electrodes. The magnitude of the resultant current is proportional to the concentration of glucose in the specimen.
The current level is converted into a readout displayed on the meter.
Contents of the kits

• A Meter
• Owner’s Manual
• Test Strips
• Lancing Device
• Sterile Lancet

NOTE:

• The Lancing Device can be used for several times, however the sterile lancet should be changed after each use.
• Control solution is not included in the standard kit.
• There are three levels for the control solutions: level 1, level 2 and level 3 available, please contact the place of purchase for more information.

If any items are missing from your kit or opened prior to use, please contact local customer services or place of purchase for assistance.

Blood Glucose Meter

1. Strip port
   Where you insert the test strip into strip port, the meter will turn on automatically.

2. Strip ejector
   Slide forward to eject the test strip after test.

3. LCD Display
   It guides you through the test using symbols and simple messages

4. “M” Button
   It is used to turn on the meter to enter the memory mode

5. “S” Button
   It is used to set up the meter

Meter Screen Display Message

1. Blood drop symbol
   Flashes when it is ready to apply the blood sample.

2. Low battery symbol
   Appears when the battery power is low.

3. Test strip symbol
   Appears when the meter is turned on.

4. Test result area
   Displays glucose results

5. Measurement unit
   Appears with the test result in mg/dL

6. CTL symbol
   Appears when doing a control test and indicates that the result won’t be stored in the memory

7. Memory symbol
   Appears when you review the memory

8. Date

9. Time

Test Strip
Each strip can be used only once. The test strip consists of the following parts:

1. Absorbent hole
   Apply a drop of blood here. The blood will be drawn in automatically.

2. Confirmation window
   This is where you confirm if enough blood has been drawn into the absorbent hole of the strip.

3. Test strip handle
   Hold this part to insert the test strip into the slot.

4. Contact bars
   Insert this end of the test strip into the meter. Push it in firmly until it will go no further.

Attention!
Test results might be wrong if the contact bar is not fully inserted into the test slot.
NOTE: The front side of the test strip should face up when inserting the test strip.

Setting the meter and deleting the memory

1. Setting the date and time
   1.1 Setting the year
   Press and Hold “S” button for 3 seconds, until the last two digits of the year will flash on the screen (for example, “14” equals 2014). Press “M” button until the correct year appears. Press “S”. 1.2 Setting the month
   With the month flashing, press “M” until the correct month appears. Press “S”.
   1.3 Setting the day
   With the day flashing, Press “M” until the correct day appears. Press “S”. 1.4 Setting the AM/PM
   With the AM or PM flashing, Press “M” until the correct one appears. Press “S”.
   1.5 Setting the hour
   With the hour flashing, Press “M” until the correct hour appears. Press S“. 1.6 Setting the minute
   With the minute flashing, Press “M” until the correct minute appears. Press “S”.

2. Deleting the Memory
   2.1 Press “S” , then “dEL” will display with flashing “M”.
   2.2 Press “M” once to confirm delete, press “M” button again to delete ALL memory. The meter then displays “OK”, which means that the memory is deleted. If you don’t want to delete the memory, press the S button to skip this step. The meter will  automatically turn “OFF”, and the set up will be completed.

NOTE:

• The date, time, unit and memory deletion can ONLY be set in the setting mode.
• When the meter is in setting mode, if no button is pressed within 3 minutes, the meter will turn off.
• No set up necessary, meter is pre-set. Meter is pre-set for Eastern Standard Time. Please refer to page 13 of this manual for set up instruction.

The two measuring modes
The meter provides you with two modes for measuring, General and CTL. The CTL mode should be used when a control solution is being tested. See the table below.

meal
CTL| Testing with the control solution

You can switch between each mode by:

1. Start with the meter turned off. Insert a test strip to turn on the meter, the screen will display a flashing blood drop, time and date.
2. Press “S” to select General or CTL mode.

Testing with blood sample

CAUTION:
To reduce the chances of infection:

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

Note: Before testing, please read the following steps thoroughly and carefully, please relax and do the test step by step.
Simplifying or changing the test procedure may produce inaccurate results.

Overview of the lancing device

A. Device Cap
B. Handle
C. Needle Cap
D. Needle Holder
E. Device Body
F. Connecting Collar
G. Adjustable Tip
H. Release Button
I .Ejection Button
J .Device Control Cap on the Lancets and the Lancing Device.

If your lancing device differs from the one shown here, please refer to the manufacturer’s manual to ensure proper usage.
NOTE:
To reduce the chance of infection:

• Never share a lancet or the lancing device.
• Always use a new, sterile lancet. Lancets are for single use only.
• Avoid getting hand lotion, oils, dirt, or debris when handling the lancets.

Setting up the lancing device

1. Screw the device cap off.
2. Put the needle into the needle holder until it reaches the bottom.
3. Screw the needle cap and put it in the recycling dustbin.
4. Cover the cap
5. Adjust the proper level (usually level 3)
6. Aiming at the sterilized part for blood-taking, press the blue release key to finish blood taking.
7. Screw the device cap.
8. Push the ejection button and discard the used lancet in appropriate container.
9. Cover the device cap.

NOTE:
The adjustable tip offers 5 levels of skin penetration. Twist the adjustable tip to the proper level:
1-2 level for soft or thin skin
3 level for average skin
4-5 level for thick or calloused skin

Preparing the puncture site

Stimulating blood perfusion by rubbing the puncture site prior to blood extraction has a significant influence on the glucose value obtained. Blood from a site that has not been rubbed exhibits a measurably different glucose concentration than blood from the finger. When the puncture site was rubbed prior to blood extraction, the difference was significantly reduced.
Please follow the suggestions below before obtaining a drop of blood:

• Rub the puncture site for about 20 seconds before penetration.
• Select the puncture site at the fingertips.
• Clean the puncture site using cotton moistened with 70% alcohol and let it air dry.

Fingertip testing

Hold the lancing device firmly against the side of your finger. Press the release key.
You will hear a click, indicating that the puncture is complete.

NOTE：

• Choose a different spot each time you test. Repeated punctures at the same spot may cause soreness and calluses.
• It is recommended to discard the first drop of blood as it might contain tissue fluid, which may affect the test result.

Performing a Blood Glucose Test

Step 1
Wash hands with soap and warm water.

Step 2
Remove a test strip from its vial. With clean and dry hands, you may touch the test strip anywhere on its surface. Do not bend, cut or modify the test strip in any way. Remove the test strip from the vial and use it instantly.
Step 3
Insert the test strip into the meter’s test port and the meter is turned on. The screen will display a flashing blood drop, time and date.

NOTE: Be sure to use G-425-2 blood glucose test strips, other test strips may not produce an accurate result.
Step 4
When the blood drop symbol flashes on the screen, you may select the appropriate measurement mode, for selecting the measurement mode of Control (CTL) or General, please refer to the “The two measuring modes” section.
Step 5
Apply your blood to the absorbent hole of the test strip. For collecting blood sample, please refer to the “Preparing the puncture site” section.
Step 6
As soon as enough blood has filled the confirmation window of the test strip, you will hear a beep letting you know the test has begun. A countdown of 5 seconds starts.
NOTE: You must wait for the end of 5-second count down to see the data display.
NOTE: Make sure the confirmation window of the Test Strip is completely filled with your blood sample.
Step 7
Your blood glucose level, along with appears on the display. Blood glucose results are automatically stored in the memory.

NOTE:
The results obtained from this meter are plasma-calibrated. This helps you and your physician or other qualified healthcare provider to compare your meter results with laboratory tests. Refer to the instructions given by your physician or other qualified healthcare
provider, do not deviate from these instructions on the basis of the result without first consulting your physician.
Step 8
Eject the used test strip and remove the lancet. To eject the test strip, point the strip at a disposal container for sharp objects. The meter will switch itself off automatically after the test strip is ejected. Please wash hands thoroughly with soap and water after handling the meter, lancing device, or test strips.

Reference value

Source: American Diabetes Association. Standards of Medical Care in Diabetes-2012. Diabetes Care 2012,35（Suppl.1) S11-S63.
Note: Please work with your doctor to determine a target range that works best for you.

Comparing Meter and Laboratory Results
The meter provides you with the measurement result equivalent to whole blood. The result you obtain from your meter may differ somewhat from your laboratory result due to normal variation. Meter results can be affected by factors and conditions that do not affect laboratory results in the same way. To make an accurate comparison between meter and laboratory results, please follow the guidelines below.

Before going to the lab:

• Do a control solution test to make sure that the meter is working properly.
• If possible, fast for at least eight hours and then do comparison tests.
• Take your meter with you to the lab.

While staying at the lab:
Make sure that the samples for both tests are taken and tested within 15 minutes of each other.

• Wash your hands and then obtain a blood sample
• Never use your meter with blood that has been collected in a gray top test tube.
• Use fresh capillary blood only.

CONTROL SOLUTION TEST
Material needed:

• Glucose meter
• Test strips
• Control solution

When to do a control solution test

• When you suspect that the meter or test strips are not working properly.
• If your blood glucose test results are not consistent with how you feel.
• After the test strips are exposed to extreme conditions.
• After dropping the meter.

The control solution is to check that the meter and the test strips can work together as a system and work correctly.

How to do a control solution test

Step 1
Insert the test strip into the meter. Wait for the meter to display the drop symbol.
Step 2
You may press “S” button to select CTL mode, for selecting the CTL mode, please refer to the “The two measuring modes” section.
Step 3
Apply the control solution.
Shake the control solution vial thoroughly before use.
Squeeze out a drop and wipe it off, then squeeze another drop and place it on the tip of the vial cap.
Hold the meter to move the absorbent hole of test strip that made it touch is the drop. Once the confirmation window filled completely, the meter will begin counting down.
To avoid contaminating the control solution, do not directly apply control solution onto a strip.
Step 4
The result of the control solution test appears on the display. The result will not be stored under CTL mode.
The result of the control solution test should be within the range printed on the test strip vial label. If the test result falls outside the specified range printed on test strip vial label, please repeat the test.
Results falling outside the specified range may be caused by:

• Error in performing the test
• Expired or contaminated Control Solution
• Expired or contaminated Test Strip
• Malfunction of your Meter

If you continue to get control solution test results that fall outside the range printed on the vial, the system may not be working properly, do not use the meter. Please contact your customer support immediately.

NOTE:

• Do not use the expired control solution.
• Users should periodically review their technique, and compare with the results that obtained from meter and obtained from laboratory method or a well-maintained and monitored system used by healthcare provider.

Viewing Results on the Meter
Your meter stores the 500 most recent blood glucose test results with dates and times.
Note: The control solution readings are not included in the average of your results.

Recalling the Stored Test Results

1. Start with the meter off, press the “M” button to turn on the meter. The “M” symbol will flash with the time and date displayed on the screen.

2. Press “M” again, the most recent test results with date and time will display. Press “M” once more and the next most recent test results will appear. Each time you press and release “M”, the meter will recall up to your last 500 test results in order. Press the “S” to turn off the meter. When the memory is full, the oldest result is dropped and the newest result is added.

Note: The control solution readings are not included in the average of your results.
When your glucose value is less than 40mg/dL, you will see the following message “Lo”; When your glucose value is higher than 600mg/dL, you will see the following message “HI”

Care and storage for your system

• Handle the meter with care. Dropping or throwing the meter may cause damage to the device.

• Don’t expose the Glucoracy Blood Glucose Monitoring System, Test Strip, and Control Solution to extreme conditions, such as high humidity, heat, freezing cold or dust. The storage conditions for the test strips are 39°F~86°F, Humidity10~85%RH. Storage
  conditions for the meter are -4°F~131°F, Humidity＜80%RH.

• Always wash your hands with soap and water then rinse and dry completely before handling the Glucoracy Blood Glucose Monitoring System and Test Strip.

• Use CaviWipes (see below) to clean the Blood Glucose Monitoring System.

• Discard the used lancet into a container for sharp objects.

Cleaning and Disinfection

The cleaning and disinfection is absolutely necessary for the test procedure, because cleaning can insure the meter works well (for example, display will be clear to see after cleaning); and disinfection can avoid the infection and cross-infection to you or to the other
people. We strongly warn that the device should be cleaned and disinfected following use on every patient. And we suggest you use the following product: CaviWipes (EPA registration number： 46781-8). You can purchase this product according to the following information: visit the web site: www.metrex.com or contact Metrex at 800-841-1428 for product or technical information. CaviWipes are also available at www.amazon. com or via a Google search. The Glucoracy G-425-2 meter can be cleaned and disinfected by the user twice per day over the 5-year use life of the device, up to 3,650 times. The meter should be cleaned and disinfected at least once per week.

Cleaning procedure:
The purpose of cleaning is to remove the dust or organic/inorganic contaminations from the glucose meters.
About that we recommend use CLOROX Healthcare Bleach Germicidal Wipes. In addition, we recommend cleaning the meters every time after use. As for the cleaning procedure, please follow the steps below:

With disinfectant towels, wiping the entire outer crust (including test strips port, data port, strip ejector, LCD Display, M button, and S button) of the meter by using CLOROX Healthcare Bleach Germicidal Wipes.
Air dried the meters and lancing devices carefully in room temperature.
Disinfection procedure:
A disinfection procedure is a procedure intended to remove the blood-borne pathogens on the meters. Disinfecting the entire outer crust of the meter with CLOROX Healthcare Bleach Germicidal Wipes carefully, including screen and button. In order to ensure the
blood-borne pathogens were removed by the disinfectant infallibly, it is necessary to keep disinfectant (disinfectant is a chemical that is applied to kill microbes) on the meter for one minute. As for the disinfecting procedure, please follow the steps below:
Wiping the entire outer crust of the meter with CLOROX Healthcare Bleach Germicidal Wipes and keeps the disinfectant on the meter for one minute.
Carefully air dried the meters in room temperature.

1. Before the test, the user should clean and wash hands. If you are a caregiver (not the patient), please use disposable gloves.
2. After test, take one wipe to clean the meter’s housing, buttons, lens, mark, usb cover and support block, including its front and back for 10 seconds cleaning until there is no soil on the surface. Then disinfect the meter’s housing, buttons, lens, mark, usb cover and support block by using another wipe for 1 min, keep the surface wet for 1 min.
3. Take off the glove; discard carefully according to your healthcare provider’s instruction.

Note:

1. Each disinfection step requires a pre-cleaning step.
2. If the meter is being operated by a second person who is providing testing assistance to the user, the meter and lancing device shall be cleaned and disinfected first.
3. The users should wash hands thoroughly with soap and water after handling the meter, lancing device, or test strips.

Specification

1. Model: G-425-2
2. Machine size: 90mm (L)×54mm (W)×13mm(H)
3. Weight: 48g (excluding batteries)
4. Measuring method: Amperometric technology using glucose oxidase
5. Measuring range: 20 mg/dL ~600 mg/dL
6. Memory: 500 blood glucose tests
7. Display: LCD display with backlight
8. Power source: DC 3V (AAA×2 alkaline batteries)
9. Battery life: Approx. 500 normal tests
10. Storage condition (system: meter and test strips): 39.2 ℉~104 ℉ and below 85% relative humidity
11. Storage condition (meter): -4 ℉~131 ℉, Humidity＜93%RH, 700hPa ~ 1060hPa
12. Operating conditions: 50 ℉~104 ℉, Humidity:10%~85%RH
13. Blood source: Fresh capillary whole blood
14. Blood volume: Minimum 0.5 micro liter.
15. Use life: five years.

DISPLAY MESSAGE

blood sugar. You should consult with your healthcare professional.
| Blood glucose level is higher than 600 mg/dl| This indicates sever. hyperglycemia (high blood glucose).You should seek immediate medical assistance.
| Meter is ready to test control solution under the CM state

| Please place a drop of control solution onto the test well of test strip.
| Battery power is low.| Please change the battery.
| Use a used test strip| Please use a new strip and re-test
| Error message indicates that you may remove prematurely the strip after applying blood to the absorbent hole| Try again with a new test strip
| Problem with the meter| Re-test with a new test strip. If the problem is still unsolved, please call the customer care line for help.
| Environmental temperature is lower than 50°F-104°F| Please test at an environmental temperature within 50°F-104°F operation range

Problems

1. Battery may be installed improperly.
2. Battery power is too low to use.
3. Too much time has passed between inserting the Test
Strip and performing the test.
4. Test Strip has not been fully  inserted into the Meter.| 1.Install the Battery correctly.
2.Replace with new Battery.
3.Reinsert the Test Strip into the Meter.
4.Reinsert the Test Strip into the Meter.
Test results are inconsistent or Control Solution test results are not fall within specified range.| 1. Not enough sample in the Test Strip.
2. Test Strip or Control Solution has expired.
3. Test Strip has been damaged due to heat or humidity so that sample cannot be applied or the speed of applying
sample is too slow.
4. System is not performing due to the environment being
above or below room temperature.| 1. Redo test with new test strip and make sure that enough    sample has been added.
2. Redo test with new test strip.
3. Perform a Control Solution test using a new Test Strip. If
results are still out of  range, replace with new vial of Test Strips.
4. Bring system to a room temperature environment and wait
approximately 30 minutes before performing a new test.
The Meter countdown did not start.| 1.Test Strip has not been inserted correctly.
2.The blood sample volume is not enough .| Use a new Test Strip and redo the test.

Performance Characteristics

Precision
Within Run Precision (300 Venous Blood Tests per Glucose Level)

Glucose concentration interval（mg/dL)| 30~50| 51~110| 111~150| 151~250| 251~400
---|---|---|---|---|---
YSI Mean (mg/dL)| 40.3| 89.9| 131.5| 199.3| 323.8
Lot 1| Mean (mg/dL)| 40.0| 89.7| 130.8| 200.0| 322.1
SD| 2.7| 3.1| 4.6| 7.2| 11.1
CV(%)| 6.6%| 3.5%| 3.5%| 3.6%| 3.4%
Lot 2| Mean (mg/dL)| 40.2| 90.2| 130.0| 199.9| 323.2
SD| 2.7| 3.1| 4.7| 6.5| 10.9
CV(%)| 6.7%| 3.5%| 3.6%| 3.3%| 3.4%
Lot 3| Mean (mg/dL)| 40.0| 89.9| 130.7| 201.3| 320.9
SD| 2.5| 3.1| 4.6| 7.0| 10.1
CV(%)| 6.3%| 3.4%| 3.5%| 3.5%| 3.1%
Pooled| Mean (mg/dL)| 40.1| 89.9| 130.5| 200.4| 322.1
SD| 2.6| 3.1| 4.6| 6.9| 10.7
CV(%)| 6.5%| 3.5%| 3.6%| 3.4%| 3.3%

Results show that the greatest variability observed between test strips when tested with blood is 3.6% or less.

Between Run Precision

Glucose concentration interval（mg/dL)| 30~50| 51~110| 111~150| 151~250| 251~400
---|---|---|---|---|---
YSI Mean (mg/dL)| 41.9| 94.0| 131.1| 199.2| 325.3
Lot 1| Mean (mg/dL)| 40.1| 90.5| 116.8| 193.0| 315.6
SD| 2.0| 2.5| 3.2| 4.8| 6.3
CV(%)| 5.1%| 2.8%| 2.8%| 2.5%| 2.0%
Lot 2| Mean (mg/dL)| 40.1| 90.3| 116.9| 192.4| 314.2
SD| 2.0| 2.7| 3.2| 4.6| 6.2
CV(%)| 5.1%| 3.0%| 2.8%| 2.4%| 2.0%
Lot 3| Mean (mg/dL)| 40.0| 89.8| 117.3| 192.1| 315.0
SD| 1.9| 2.5| 2.9| 4.0| 6.0
CV(%)| 4.9%| 2.8%| 2.5%| 2.1%| 1.9%
Pooled| Mean (mg/dL)| 40.1| 90.2| 117| 192.5| 314.9
SD| 2.0| 2.6| 3.1| 4.5| 6.2
CV(%)| 5.0%| 2.9%| 2.7%| 2.3%| 2.0%

Results show that the greatest variability observed between test strips when tested with blood is 2.9% or less.

Lay-user performance study

Different range between the true blood glucose level and the G-25-2 meter result| Within ±5%| Within ±10%| Within ±15%| Within ±20%
---|---|---|---|---
The percent (and number) of meter results that match true blood glucose level within x%| 49.29% (173/351)| 83.48% (293/351)| 98.58% (346/351)| 100% (351/351)

Traceability of glucose monitoring system
The results of G-425-2 Glucoracy Blood Glucose Monitoring System were compared to parallel results obtained on YSI-2300, which is the manufacturer’s standard measurement procedure.

Electrical and safety standards
This meter complies with CISPR 11: Class B (Radiated Only).
Emissions of the energy used are low and not likely to cause interference in nearby electronic equipment. The meter has been tested for immunity to Level 3 electrostatic discharge as specified in IEC 61326. This meter complies with immunity to radio frequency
interference over the frequency range 80MHz to 2.5GHz at 3V/m as specified in IEC 60601-1-2.
The meter meets the requirements for immunity to electrical interference at the frequency range and test level specified in international standard ISO 15197.

Use of this meter near electrical or electronic equipment that are sources of electromagnetic radiation, may interfere with proper operation of this meter. It is advisable to avoid testing in close proximity to sources of electromagnetic radiation.
Common sources of electromagnetic radiation include mobile phones, walkie talkies or garage door openers.
Do not use the equipment where aerosol sprays are being used, or when oxygen is being administered.

FCC Requirement

Changes or modifications not expressly approved by the party responsible for compliance could void the user authority to operate the equipment.
This device complies with Part 15 of the FCC Rules. Operation is subject to the following two conditions:

1. This device may not cause harmful interference.
2. This device must accept any interference received, including interference that may cause undesired operation.

Note: This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to Part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference in a residential installation. This
equipment generates, uses, and can radiate radio frequency energy, and if not installed and used in accordance with the instructions, might cause harmful interference to radio communications. However, there is no guarantee that interference will not occur in a particular installation. If this equipment does cause harmful interference to radio or television reception, which can be determined by turning the equipment off and on, the user is encouraged to try to correct the interference by one or more of the following measures:

• Reorient or relocate the receiving antenna.
• Increase the separation between the equipment and receiver.
• Connect the equipment into an outlet on a circuit different from that to which the receiver is connected.
• Consult the dealer or an experienced radio/TV technician for help.

This equipment complies with FCC radiation exposure limits set forth for an uncontrolled environment. This equipment should be installed and operated with a minimum distance of 20cm between the radiator & your body. This transmitter must not be co-located or operated in conjunction with any other antenna or transmitter.

References

• Homepage | Metrex

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