FORA GD20 Blood Glucose Monitoring System

IMPORTANT SAFETY PRECAUTIONS

READ BEFORE USE

Users need to adhere to Standard Precautions when handling or using this device. All parts of the glucose monitoring system should be considered potentially infectious and are capable of transmitting blood-borne pathogens between patients and healthcare professionals. For more information, refer to "Guideline for Isolation Precautions: Preventing Transmission of Infectious Agents in Healthcare Settings 2007", http://www.cdc.gov/hicpac/2007ip/2007isolationprecautions.html.

• The meter should be disinfected after use on each patient. This Blood Glucose Monitoring System may only be used for testing multiple patients when Standard Precautions and the manufacturer's disinfection procedures are followed.
• Only auto-disabling, single use lancing devices should be used with this device.
• 1. Use this device ONLY for the intended use described in this manual.
• 2. DO NOT use accessories which are not specified by the manufacturer.
• 3. DO NOT use the device if it is not working properly or if it is damaged.
• 4. DO NOT under any circumstances use the device on neonates or infants.
• 5. This device does NOT serve as a cure for any symptoms or diseases. The data measured is for reference only.
• 6. Before using this device to test blood glucose, read all instructions thoroughly and practice the test. Carry out all the quality control checks as directed.
• 7. Keep the device and testing equipment away from young children. Small items such as the battery cover, batteries, test strips, lancets and vial caps are choking hazards.

Interfering Substances

Interfering substances depend on the concentration. The interfering substances listed below may produce elevated glucose test results (up to concentration levels noted).

* The NaF/Koxalate concentration is the standard concentration in a blood collection tube.

Regulatory Requirements

The Clinical Laboratory Improvement Amendments (CLIA) has classified tests of blood glucose as tests that are waived. For all entities that conduct one or more tests, including waived tests on materials derived from the human body for the purpose of providing information for the diagnosis, prevention or treatment of any disease or impairment of, or the assessment of the health of human beings, CLIA has stated that the entity conducting the tests shall meet certain Federal requirements. If any entity conducts tests for the aforementioned purposes, then the entity, under CLIA, is considered to be a laboratory and thus must register with the CLIA Program.

KEEP THESE INSTRUCTIONS IN A SAFE PLACE

BEFORE YOU BEGIN

Severe dehydration and excessive water loss may cause readings which are lower than actual values. If the patient is suffering from severe dehydration, consult a healthcare professional immediately.

• If the patient's blood glucose results are lower or higher than usual, and do not have any symptoms of illness, first repeat the test. If the patient has symptoms or continue to get results which are higher or lower than usual, follow the treatment advice of the healthcare professional.
• Use only fresh capillary or venous whole blood samples to test patient's blood glucose. Using other substances will lead to incorrect results.
• If the patient has symptoms that are inconsistent with the blood glucose test results and you have followed all the instructions given in this owner's manual, contact the healthcare professional.
• We do not recommend using this product on severely hypotensive individuals or patients in shock. Readings which are lower than actual values may occur for individuals experiencing a hyperglycaemic-hyperosmolar state, with or without ketosis. Please consult the healthcare professional before use.

INTENDED USE

This system is intended for use outside the body (in vitro diagnostic use) by healthcare professionals for multiple patient use in a professional healthcare setting. Additionally, it is intended to be used for the quantitative measurement of glucose in fresh capillary blood (from the finger, palm, forearm and upper arm) or venous whole blood samples.

It should not be used for the diagnosis of diabetes, or testing on neonates.

Alternative site testing should be done only during steady-state times (when glucose is not changing rapidly).

TEST PRINCIPLE

Your system measures the amount of sugar (glucose) in whole blood. The glucose testing is based on the measurement of electrical current generated by the reaction of glucose with the reagent of the strip. The strength of the current produced by the reaction depends on the amount of glucose in the blood sample.

This system uses enzyme of FAD-dependent glucose dehydrogenase.

ALTERNATIVE SITE TESTING

IMPORTANT: There are limitations with AST (Alternative Site Testing). The alternative site testing of the system can be used in only during steady-state blood glucose conditions. Please consult the doctor before you perform AST on the patient.

Measurements from alternative site testing should never be used to calibrate a continuous glucose monitoring systems (CGMs) or entered into insulin dose calculators for insulin dosing recommendations.

What is AST? Alternative site testing (AST) means that people use parts of the body other than fingertips to check their blood glucose levels. This system provides you to test on the palm, the forearm, the upper arm, and with the equivalent results to fingertip testing.

What's the advantage? Fingertips feel pain more readily because they are full of nerve endings (receptors). At other body sites, since nerve endings were not so condensed, patients will not feel as much pain as at the fingertip.

When to use AST?

Food, medication, illness, stress and exercise can affect blood glucose levels. Capillary blood at fingertip reflects these changes faster than capillary blood at other sites. Therefore when testing blood glucose during or immediately after meal, physical exercise, or any other event, take blood sample from finger only. We strongly recommend that you perform AST ONLY at the following times:

• In a pre-meal or fasting state (more than 2 hours since the last meal).
• Two hours or more after taking insulin.
• Two hours or more after exercise.

Do NOT use AST if:

• Your patient has frequent low blood glucose.
• The AST results do not match the way the patient feels.
• You are testing for hyperglycemia.
• You are testing for hypoglycemia.
• The patient's routine glucose results are often fluctuating.

METER OVERVIEW

A diagram shows the FORA GD20 meter from different angles: front, back, top, and bottom. Key components are numbered:

1. Display Screen
2. M Button
3. Test Slot
4. Test Strip Ejector
5. Data Port
6. C Button
7. SET Button

The Display Screen section shows a diagram of the meter's display with numbered elements and their meanings:

1. Blood sample symbol
2. Test strip symbol
3. Low battery symbol
4. Test result
5. Measurement unit
6. Memory symbol
7. Day average
8. Reminder alarm
9. Time
10. Date
11. Control solution mode
12. Ketone warning
13. Error

Test Strip

Details on the test strip:

• Front/Back: Indicates the orientation. The front side should face up when inserting.
• 1 Absorbent Hole: Apply a drop of blood here; it will be automatically absorbed.
• 2 Confirmation Window: Used to confirm if enough blood has been applied.
• 3 Test Strip Handle: Part to hold when inserting the strip.
• 4 Contact Bars: Insert this end into the meter until it goes no further.

ATTENTION: Test results might be wrong if the contact bar is not fully inserted into the test slot.

NOTE

• This system uses enzyme of glucose dehydrogenase (GDH).
• The FORA GD20 meter should only be used with FORA GD20 Test Strips. Using other test strips with this meter will produce inaccurate results.

Setting the Meter

Before using the meter for the first time or after changing the battery, check and update settings.

Entering the Setting Mode

Start with the meter off (no test strip inserted). Press [SET] to turn on the meter.

1. Setting the date

With the year flashing, press [M] to select the correct year. Press [SET]. With the month flashing, press [M] to select the correct month. Press [SET]. With the day flashing, press [M] to select the correct day. Press [SET].

2. Setting the time format

Press and release [M] to select the desired time format (12h or 24h). Press [SET] to confirm.

3. Setting the time

With the hour flashing, press [M] to select the correct hour. Press [SET] to confirm. With the minute flashing, press [M] to select the correct minute. Press [SET] to confirm.

4. Deleting the memory

With "dEL" and a flashing [M] symbol on the display, press [M] and select "No" to keep results in memory, then press [SET] to skip. To delete all results, press [M] to select "Yes", then press [SET] to delete All results. "OK" will be displayed, indicating data is deleted.

5. Setting the reminder alarm

You may set up any or all of the reminder alarms (1-4). The meter displays "On" or "OFF" and ⏰. Press [M] to turn on or turn off to set the first reminder alarm.

Press [M] to select "On", then press [SET] to set the hour. When the hour is flashing, press [M] to add an hour. Press [SET] to confirm. Adjust the minutes by pressing [M] to add one minute. Hold [M] longer to add faster. Press [SET] to confirm and go to the next alarm setting.

If you do not want to set an alarm, press [SET] to skip. To turn off an alarm, find the alarm number by pressing [SET] in setting mode, press [M] to change from "ON" to "OFF". At the alarm time, the meter will beep and automatically turn on.

You can press [M] to silence the alarm and insert a test strip to begin testing. If you do not press [M], the meter will beep for 2 minutes then switch off. If you do not want to test at this time, press [M] to switch off the meter.

NOTE

• These parameters can ONLY be changed in the setting mode.
• If the meter is idle for 3 minutes during the setting mode, it will automatically switch off.

QUALITY CONTROL TESTING

Quality control testing using the FORA Control Solution is required to check the performance of the FORA GD20 Blood Glucose Monitoring System. The FORA Control Solution checks if the meter and test strips are working correctly as a system and if the system is being utilized correctly.

WARNING: When doing a control solution test, you need to Press [C] to mark it so the test result will not be stored in the memory. Failure to do so will mix up the control solution test with a blood glucose test result in the memory.

3. Apply control solution

Shake the control solution vial thoroughly before use. Squeeze out a drop and wipe it off, then squeeze out another drop and place it on the tip of the vial cap.

Hold the meter to move the sample area of the test strip to touch the drop. Once the confirmation window fills completely, the meter will begin counting down.

To avoid contaminating the control solution, do not directly apply control solution onto a strip.

4. Read and compare the result

After counting down to 0, the control solution test result will appear on the display. Compare this result with the range printed on the test strip vial. It should fall within this range. If not, please read the instructions again and repeat the control solution test.

NOTE

• Only use the control solutions for FORA GD20 test strips.
• When using a new bottle of control solution, write the opening date on the bottle label. Each bottle of control solution is stable for use within 90 days after first opening (replace cap tightly after each use). Discard all remaining open solutions after 90 days.
• Shake the control solution bottle several times before use, discard the first drop of control solution and wipe off the dispenser tip to ensure a pure sample and an accurate result.

Equipment Needed:

1. FORA GD20 Blood Glucose Meter
2. FORA GD20 (GDH) Control Solutions
3. FORA GD20 Test Strips
4. FORA GD20 Meter Record Sheet

Performing a Control Solution Test

1. Insert the test strip to turn on the meter

Insert the test strip into the meter. Wait for the meter to display the test strip and blood drop symbols.

2. Press [C] to mark this test as a control solution test

With "CTL" displayed, the meter will not store your test result in memory. If you press the [C] button again, the "CTL" will disappear and this test is no longer a control solution test.

5. Record the results.

Record the control solution test results in the System Quality Control Results Record sheet or as instructed by your facility.

Out-of-range results

If you continue to have test results fall outside the range printed on the test strip vial, the meter and/or strips may not be working properly. Please check the Troubleshooting section for possible causes and actions. If a problem still persists, contact Customer Service at (888) 425-1149 for assistance.

BLOOD GLUCOSE TESTING

If a single meter is used to test multiple patients, the meter must be cleaned and disinfected using the instructions as specified in this manual after each use, whether or not blood contamination is suspected.

Equipment Needed:

1. FORA GD20 Blood Glucose Meter
2. FORA GD20 Test Strips
3. Safety lancet
4. Gloves
5. Alcohol wipe or swab

Only auto-disabling, single use lancing devices should be used with this device.

Preparing the Puncture Site

Stimulating blood perfusion by rubbing the puncture site before blood extraction has a significant influence on the glucose value obtained.

Please follow the suggestions below before obtaining a drop of blood:

1. Wash and dry your hands before starting.
2. Put on a new pair of gloves.
3. Select the puncture site.
4. Clean the puncture site using cotton moistened with 70% alcohol and let it air dry.
5. Rub the puncture site for about 20 seconds before penetration.

Fingertip testing

Press the lancing device's tip firmly against the lower side of patient's fingertip.

Blood from sites other than the fingertip

When lancing the palm, forearm and upper arm, avoid lancing the areas with obvious veins because of excessive bleeding.

NOTE

• Choose a different spot each time you test. Repeated punctures at the same spot may cause soreness and calluses.
• It is recommended that you discard the first drop of blood as it might contain tissue fluid, which may affect the test result.
• When cleaning the puncture site, make sure alcohol is thoroughly dry before the puncture site is lanced. Testing with alcohol remaining on skin can cause higher results.

Performing a Blood Glucose Test

Consult manufacturer's instructions for additional information regarding the use of the FORA GD20 Blood Glucose Meter.

1. Verify physician's order.
2. Identify the patient.
3. Explain procedure.
4. Provide privacy.
5. Wash hands.
6. Put on non-sterile gloves.
7. Ensure that the meter and test strips are at room temperature. If there is a temperature change, the meter and test strips should sit at room temperature for 10 to 12 minutes.
8. Verify that the vial of test strips has not expired and/or that the vial has not been opened for longer than 90 days. Discard the vial of test strips if it has expired and/or has been opened for more than 90 days.
9. Cleanse area that is to be punctured with an alcohol swab. Allow area to dry.
10. Insert a test strip in the meter.
11. Lightly hold lancet device against the skin and lance the area. Obtain a blood sample (a hanging drop of blood).
12. Make contact with the blood sample to the sample area of the test strip. Blood will be wicked and after the confirmation window is filled, the meter will begin counting down. (0.7 µL blood sample required)
13. Read the result.
14. Eject the used test strip.
15. Clean and/or disinfect the meter following the cleaning and disinfecting procedures in this manual.
16. Remove gloves and wash hands.

NOTE

• Do not press the punctured site against the test strip or try to smear the blood.
• If you do not apply a blood sample to the test strip within 3 minutes, the meter will automatically turn off. You must remove and reinsert the test strip to start a new test.
• The confirmation window should be filled with blood before the meter begins to count down. NEVER try to add more blood to the test strip after the blood sample has moved away. Discard the used test strip and retest with a new one.
• If you have trouble filling the confirmation window, please contact Customer Service at (888) 425-1149.

CLEANING AND DISINFECTION PROCEDURES

Cleaning & Disinfecting the FORA GD20 Blood Glucose Meter

It is Links Medical Product's policy to advise healthcare professionals to clean and disinfect blood glucose meters between each resident test in order to avoid cross-contamination issues. Whether your facility uses an alcohol based solution or a bleach based solution should depend upon your individual resident requirements and your facility's disinfection protocol.

Links Medical Product's cleaning and disinfecting guidelines are as follows:

FORA GD20 Cleaning Guidelines:

Use a lint-free cloth dampened with soapy water or isopropyl (70% - 80%) to clean the outside of the blood glucose meter.

NOTE: Lint-free cloth should not be dripping wet when cleaning the meter.

FORA GD20 Disinfecting Guidelines:

To disinfect the meter, dilute 1 mL of household bleach (5% - 6% sodium hypochlorite solution) in 9 mL of water to achieve a 1:10 dilution (final concentration of 0.5% - 0.6% sodium hypochlorite). The solution can then be used to dampen a paper towel (do not saturate the towel). Then use the damped towel to thoroughly wipe down the meter.

Please note that there are commercially available 1:10 quaternary/alcohol wipes and bleach wipes from a variety of manufacturers. Professional Disposables Inc (PDI) is an example of a manufacturer that offers both of these options.

Their product offerings include:

• Super Sani-Cloth™ Germicidal Wipe - ideal disinfection for most residents and hard surfaces.
• Sani-Cloth™ Bleach Germicidal Disposable Wipe - ideal disinfection for residents with C-Diff.

Both germicidal wipes mentioned above are EPA registered wipes that are compliant with the CDC guideline for disinfection and sterilization in healthcare facilities and are readily available through major medical distributors. When using any disinfection wipe, take extreme care not to get liquid in the test strip dock or key code parts of the meter. With all recommended glucose meter cleaning methods, it is crucial that the FORA GD20 meter be completely dry before testing a resident's glucose level. Please follow the disinfectant product label instructions to ensure proper drying time.

While there are many other options for disinfecting blood glucose meters, Links Medical Products has not tested the effectiveness of these products on the FORA GD20 meter. If you use a product or method other than those that we've recommended above, you should document accordingly in your cleaning protocol.

METER MEMORY

The meter stores the 448 most recent blood glucose test results along with respective dates and times in its memory. To enter the meter memory, start with the meter switched off.

Reviewing Test Results

1. Press and release [M]. [M] will appear on the display. Press [M] again, and the first reading you see is the last blood glucose result along with date and time.
2. Press [M] repeatedly to recall the test results stored in the meter.
3. Exit the meter memory. After the last test results, press [M] again and the meter will be turned off.

Reviewing Blood Glucose Day Average Results

1. Press and release [M]. When [AVG] appears on the display, keep pressing [M] for 3 seconds until the flashing "DAY" appears. Release [M] and then your 7-day average result measured in general mode will appear on the display.
2. Press [M] to review 14-, 21-, 28-, 60- and 90-day average results stored in memory.
3. Exit the meter memory. Keep pressing [M] and the meter will turn off after displaying the last test result.

DOWNLOADING RESULTS ONTO A COMPUTER

You can use the meter with an interface cable and the Health Care Software System to view test results on your personal computer. To learn more about the Health Care Software System or to obtain an interface cable separately, please visit www.foracare.com or call (888) 425-1149 for assistance.

1. Obtaining the required cable and installing the software

To download the Health Care Software System, please visit the FORA Care Inc. website at www.foracare.com.

2. Connecting to a personal computer

Connect the cable to an interface port on your computer. With the meter switched off, connect the other end of the interface cable to the meter data port. "PC" will appear on the meter display, indicating that the meter is in communication mode.

3. Data transmission

To transmit data, follow the instructions provided with the software. Results will be transmitted with date and time. Remove the cable and the meter will automatically switch off.

WARNING: While the meter is connecting to the PC, it will be unable to perform a blood glucose test.

MAINTENANCE

Battery

Your meter comes with one 3V CR2032 lithium battery.

Low Battery Signal

The meter will display one of the messages below to alert you when the meter's power is getting low.

1. The ? symbol appears along with a display message: The meter is functional and the results remain accurate, but it is time to change the battery.
2. The meter displays E-b: There is not enough power for a test. Please change the battery immediately.

Replacing the Battery

To replace the battery, make sure that the meter is turned off.

1. Press the edge of the battery clip and lift it up to remove.
2. Remove the old battery and replace with a new 3V CR2032 lithium battery.
3. Close the battery cover. If the battery is inserted correctly, you will hear a "beep" confirming the battery has been properly inserted.

NOTE

• Replacing the battery does not affect the test results stored in the memory.
• Battery might leak chemicals if unused for a long period of time. Remove the battery if you are not planning to use the device for an extended period (i.e., 3 months or more).
• Properly dispose of the battery according to your local environmental regulations.

Meter Storage

Storage conditions: -4°F to 140°F (-2°C to 6°C), below 95% relative humidity.

• Always store or transport the meter in its original storage case.
• Avoid dropping and heavy impact.
• Avoid direct sunlight and high humidity.

Important Test Strip Information

• Storage conditions: 35.6°F to 89.6°F (2°C to 32°C), below 85% relative humidity. Do not freeze.
• Store your test strips in their original vial only. Do not transfer to another container.
• Store test strip packages in a cool dry place. Keep away from direct sunlight and heat.
• After removing a test strip from the vial, immediately close the vial cap tightly.
• Touch the test strip with clean and dry hands.
• Use each test strip immediately after removing it from the vial.
• Write the opening date on the vial label when you first open it. Discard remaining test strips after 3 months (90 days).
• Do not use test strips beyond the expiration date. This may cause inaccurate results.
• Do not bend, cut, or alter a test strip in any way.
• Keep the strip vial away from children. The cap and the test strip may be a choking hazard. If swallowed, promptly seek medical attention.

For further information, please refer to the test strip package insert.

Important Control Solution Information

• Use only FORA control solutions with your meter.

SYSTEM TROUBLESHOOTING

If you follow the recommended action but the problem persists, or error messages other than the ones below appear, please call (888) 425-1149 for assistance. Do not attempt to repair yourself and never try to disassemble the meter under any circumstances.

Result Readings

Error Messages

Troubleshooting

1. If the meter does not display a message after inserting a test strip:

2. If the test does not start after applying the sample:

3. If the control solution testing result is out of range.

SPECIFICATIONS

Model No.: TD-4251

Dimension & Weight: 86.9mm(L) x 51mm(W) x 15.8mm(H), 42.2g

Power Source: one CR2032 lithium battery

Display: LCD

Memory: 448 measurement results with respective date and time

External output: RS232 PC interface

• Auto electrode insertion detection
• Auto sample loading detection
• Auto reaction time count-down
• Auto switch-off after 3 minutes without action
• Temperature warning

Operating Condition: 50°F to 104°F (10°C to 40°C), below 85% R.H. (non-condensing)

Storage/Transportation Conditions:

• Meter: -4°F to 140°F (-20°C to 60°C), below 95% R.H.
• Test strip: 35.6°F to 89.6°F (2°C to 32°C), below 85% R.H. Do not freeze.

Measurement Units: mg/dL

Measurement Range: 20 to 600mg/dL (1.1 to 33.3mmol/L)

This device has been tested to meet the electrical and safety requirements of: IEC/EN 61010-1, IEC/EN 61010-2-101, EN 61326-1, IEC/EN 61326-2-2.

Distributed by:

Links Medical Products Inc.®
15979 North 76th Street, Unit D, Scottsdale, AZ 85260
Toll Free: (888) 425-1149 (8:00am-5:00pm PST, Mon.-Fri.)
www.linksmed.com

Manufactured by:

ForaCare Inc.
893 Patriot Dr., Suite D
Moorpark, CA 93021

Quality Control Results Record

A table is provided for recording quality control results, including columns for Meter #, Date, Time, Operator, Meter cleaned (Y/N), Test strip lot #, Test strip expiration dates, Results reviewed by, Low Control lot #, Low Control range, Low Control result, High Control lot #, High Control range, High Control result, and Corrective Action.

Notes

Blank lines are provided for notes.