FORA TD-4183F Test N’GO Advance Voice Lactate Test System Owner’s Manual

Lactate Test System
Owner’s Manual

TD-4183F Test N’GO Advance Voice Lactate Test System

Dear FORA Test N’GO Advance
Voice System Owner:
Thank you for purchasing the FORA Test N’GO Advance Voice Lactate Test System. This manual provides important information to help you use the system properly. Before using this system, please read and follow the instructions in this Owner’s Manual.
The system measures lactate levels. Due to its compact size and easy operation, you can use the FORA Test N’GO Advance Voice Lactate Test System to easily monitor your lactate levels anywhere, any time.
If you have other questions regarding this product, please contact the place of purchase or call our customer service line at 1-888-3078188 (6:30 am – 5:30 pm PST, Mon. – Fri.). For any further medical assistance, please contact your healthcare professional.
Version 1.0 2023/08
311-4183600-008

IMPORTANT SAFETY PRECAUTIONS

READ BEFORE USE

• For over-the-counter use only.

• The meter and lancing device are for single patient use only. Do not share them with anyone including your family members! 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.
  For more information, please visit
  “FDA Public Health Notification: Use of Fingerstick Devices on More than One Person Poses Risk for Transmitting Bloodborne
  Pathogens: Initial Communication” (2010)
  https://wayback.archive-it.org/7993/20170111013014/
  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://www.cdc.gov/injectionsafety/Fingerstick- DevicesBGM.html

• Use this device ONLY for the intended use described in this manual.

• Do NOT use accessories which are not specified by the manufacturer.

• Do NOT use the device if it is not working properly or if it is damaged.

• Do NOT under any circumstances use the device on newborns or infants.

• This device does NOT serve as a cure for any symptoms or diseases. The data measured is for reference only. Always consult your doctor  to have the results interpreted.

• Before using this device to test lactate, read all instructions thoroughly and practice the test. Carry out all the quality control checks as directed.

• 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.

• Use of this instrument in a dry environment, especially if synthetic materials are present (synthetic clothing, carpets etc.) may cause damaging static discharges that may cause erroneous results.

• Do NOT use this instrument in close proximity to sources of strong electromagnetic radiation, as these may interfere with the accurate operation.

• Proper maintenance and periodical control solution tests are essential to the longevity of your device. If you are concerned about your accuracy of measurement, please contact customer service or place of purchase for help.

• This device is NOT intended for use in screening or diagnosis of familial or acquired genetic disorders, including inborn errors of metabolism.

• This device is NOT intended for assessing the risk of cardiovascular diseases.

• This device is NOT intended for near patient testing (point of care).

• This device is NOT intended for use in healthcare or assisted-use settings such as hospitals, physician offices, or long-term care facilities. 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.

KEEP THESE INSTRUCTIONS IN A SAFE PLACE

BEFORE YOU BEGIN

Important Information

• Severe dehydration and excessive water loss may cause readings which are lower than actual values. If you believe you are suffering from severe dehydration, consult a healthcare professional immediately.
• If your lactate results are lower or higher than usual, and you do not have any symptoms of illness, first repeat the test. If you have symptoms or continue to get results which are higher or lower than usual, follow the treatment advice of your healthcare   professional.
• Use only fresh capillary whole blood samples from fingertips to test your lactate. Using other substances will lead to incorrect results.
• If you are experiencing symptoms that are inconsistent with your test results and you have followed all the instructions given in this owner’s manual, contact your healthcare professional.
• We do not recommend using this product on severely hypotensive individuals or patients in shock. Please consult your healthcare professional before use.

Intended Use
The FORA Test N’GO Advance Voice Lactate Test System is intended for the quantitative measurement of lactate in fresh capillary whole blood from the fingertips. The FORA Test N’GO Advance Voice Lactate Test System is intended for self-testing outside the body (in vitro diagnostic use) by lay user as an aid in measuring the lactate. The system is not intended for the diagnosis of or screening for diseases, and is not intended for use on neonates.

Test Principle
Your system measures the amount of lactate in fresh capillary whole blood samples from fingertips. The lactate testing is based on the  measurement of electrical current generated by the reaction of lactate with the reagent of the strip. The meter measures the current, calculates the lactate level, and displays the result. The strength of the current produced by the reaction depends on the amount of lactate in the blood sample.
Contents of System
The FORA Test N’GO Advance Voice Lactate Test System kit  includes:

1. Meter
2. Owner’s Manual
3. Protective Wallet
4. Quick Start User Guide / Warranty Card
5. Daily Log Book
6. 2 x 1.5V AAA Battery
7. 10 Lactate Test Strips
8. Control Solution
9. Lactate Code Strip
10. 10 Lancets
11. Lancing Device
12. Lactate Strip Manual
13. Lancing Device Manual

Test strips, control solution, sterile lancets and lancing device may be purchased separately. Please make sure you have those items needed for a lactate test beforehand.
NOTE:
 If any items are missing from your kit or opened prior to use, or to obtain test strips and control solutions, please contact the place of purchase or call Customer Service for assistance.

Meter Overview

1. Test Strip Slot
   Insert test strip here to turn the meter on for testing.

2. Strip Indication Light

3. Bluetooth Indicator
   Download test results with a Bluetooth connection.

4. Test Strip Ejector
   Eject the used strip by pushing up this button.

5. Display Screen

6. ◄ Button

7. MAIN Button
   Enter the meter memory.

8. ► Button
   Can be used to silence a reminder alarm.

9. Battery Compartment

Meter Display

1. Lactate Testing
2. Test Result
3. Low Battery Symbol
4. Measuring Mode
5. Memory Symbol
6. Error Message
7. Date / Time
8. Alarm Symbol
9. Measurement Unit
10. Volume Symbol
11. Test Strip Symbol
12. Blood Drop Symbol
13. Code

Speaking Function
The meter “speaks” aloud with step-by-step instructions to guide you through the process of using the meter. The following table tells you when and what the monitor “speaks”.

millimoles per liter.
After inserting a test strip| The code number is (number). Please apply blood into the strip.
Measuring warning| Lactate is out of range, unable to measure.

NOTICE: You can press MAIN to skip the voice when the meter “speaks”.
Test Strip

1. Absorbent Hole
   Apply a drop of blood here. The blood will be automatically absorbed.

2. Confirmation Window
   This is where you confirm if enough blood has been applied to the absorbent hole in the strip.

3. Test Strip Handle
   Hold this part to insert the test strip into the meter slot.

4. Contact Bars
   Insert this end of the test strip into the meter. Push it in firmly until it stops.

ATTENTION:
The front side of test strip should face up when inserting test strip.

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

NOTE:

• The FORA Test N’GO Advance Voice Lactate Test System should only be used with FORA Test N’GO Advance Voice Lactate Test Strips. Using other test strips with this monitoring system can produce inaccurate results.

Setting the Meter
Before using your meter for the first time or if you change the meter battery, you should check and update these settings. Make sure you complete the steps below and have your desired settings saved.

Entering the Setting Mode
Start with the meter off (no test strip inserted). Press ◄ and ► buttons at the same time to enter Setting Mode.

1. Setting the date
   With the year flashing, press ◄/► button until the correct year appears. Press MAIN.
   With the month flashing, press ◄/► button until the correct month appears. Press MAIN. With the day flashing, press ◄/► button until the correct day appears. Press MAIN.

2. Setting the time
   With the hour flashing, press ◄/► button until the correct hour appears. Press MAIN.
   With the minute flashing, press ◄/► button until the correct minute appears. Press MAIN.

3. Deleting the memory
   With “dEL” and “ ” on the display, press ► button and select “no” to keep the results in memory then press MAIN to skip.
   To delete all the results, press ► button and “yes” and “ ” will be displayed on the meter, press MAIN to delete the memory.

4. Setting the speaking volume
   There are seven (7) speaking volume levels to choose from. Press ◄/► until the desired speaking volume appears. To confirm your selection, press MAIN. Volume 0 indicates that the speaking function is turned off, and “ ” will not display during testing. Volume 1 to 7 indicates speaking volume from low to high, and “ ” will be displayed throughout the testing.

5. Choosing a language
   Press ◄/► to select L1/L2/L3. The default language for the meter is L1,  which is English. L2 is for Spanish,and L3 is for Chinese (Mandarin). To confirm your selection, press MAIN.

6. Setting the reminder alarm
   You may set up any or all of the reminder alarms (1-4). The meter displays “OFF”, “ ” and “AL1”; press ◄/► button to turn on or turn off to set the first reminder alarm.

Press ◄/► button to select “On”, and then press MAIN to set the hour. When the hour is flashing, press ◄/► button to set an hour. Press MAIN to confirm and go to minutes, and then press ◄/► button to set minutes.
Press MAIN to confirm and go to the next alarm setting.

If you do not want to set an alarm, press MAIN to skip this step. If you want to turn off an alarm, select the alarm number by pressing MAIN in the setting mode, and then press ◄/► button to change displayed message from “On” to “OFF”.
At the pre-set alarm time, the meter will beep and automatically turn on. You can press ► button to mute the alarm and insert a test strip to begin testing. If you do not press ► button, the meter will beep for 2 minutes and then switch off.

Congratulations! You have completed all settings!

NOTE:

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

MEASURING MODE

One Measuring Mode for Lactate Testing
The meter provides you with one mode for lactate testing: General.

Insert a lactate test strip to turn on the meter. The screen will display: “ ” and “LAC”.

Start with the meter switched off.
Insert a lactate test strip to turn on the meter. The screen will display: “ ” and “LAC”.

BEFORE TESTING

Calibration for Testing
You must calibrate the meter every time you begin to use a new box of lactate test strips by setting the meter with the correct code. Test results may be inaccurate if the code number displayed on the monitor does not match the number printed on the individual foil packet.
How to Code Your Meter

1. Insert the code strip when the monitor is off. Wait until the code number appears on the display. NOTICE:
    Make sure the code number on display, code strip, and the individual foil package are the same. The code strip should be within the expiration date; otherwise, an error message may appear.

2. Remove the code strip, the display will show “OFF”. This tells you that the meter has finished coding and is ready for a test.

Checking the Code Number

You need to make sure that the code number displayed on the meter matches the number on the test strip vial or individual foil packet before you proceed. If it matches, you can proceed with your test. If the codes do not match, please stop testing and contact Customer Service for help.

NOTICE:

• The code number on this image is only for reference, it may not be the actual code for this meter.

WARNING:

• It is important to make sure that the displayed code is the same as the code on the test strip vial or individual foil packet before testing. Failure to do so will get inaccurate results.
• The code number for lactate test strip is three-digits; please ensure you are using the correct test strips for the test.
• If the displayed code is not the same as the code on the test strip vial or individual foil packet, and the code number cannot be updated, please contact Customer Service for assistance.

Control Solution Testing
Our control solutions contain a known amount of lactate that reacts
with test strips and that are used to ensure your meter and test stripsare working together correctly.
Test strips, control solutions, or sterile lancets may not be included in the kit (please check the contents on your product box). They can be purchased separately. Please make sure you have those items needed for a blood test beforehand.

Do a control solution test when:

• you first receive the meter,
• at least once a week to routinely check the meter and test strips,
• you begin using a new vial or new box of individual foil package of test strips,
• you suspect the meter or test strips are not working properly,
• your blood test results are not consistent with how you feel, or if you think the results are not accurate,
• practicing the testing process, or
• you dropped or think you have damaged the meter.

Performing a Control Solution Test

1. Insert the test strip to turn on the meter
   Wait for the meter to display a flashing “ ”.

2. Apply control solution Shake the control solution vial thoroughly before use. Squeeze out a drop and wipe it off, and then squeeze out another drop and place it on the tip of the vial cap. Hold the meter in an angled position so that  the absorbent hole of the test strip touches the drop. Once the confirmation window fills completely, the meter will begin counting down.
   NOTE:
    For the control solution test, your device will tag this measurement as QC test automatically.
    To avoid contaminating the control solution, do not directly apply control the solution onto the strip.

3. Read and compare the results
   After the meter counts to 0, the result of the control solution test will appear. Compare the result with the range printed on the test strip vial or individual foil package. The result should fall within this range. If not, please read the instructions again and repeat the control solution test.
   With “QC” displayed, the meter will store your test result in memory under “QC”.

Out-of-range results
If you continue to have test results fall outside the range printed on the test strip vial or individual foil package, the meter and strips may not be working properly. Do NOT test your blood, and call customer service for help.

NOTE:
 The control solution range printed on the test strip vial or individual foil package is for control solution use only. It is not a recommended range for your lactate level.
 See the MAINTENANCE section for important information about your control solutions.

TESTING WITH A BLOOD SAMPLE

WARNING:
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 in or on the lancets and the lancing device.
• Wash and dry your hands thoroughly after handling the meter, lancing device and test strips to prevent infection. For more information, please refer to the MAINTENANCE section.
• If the meter is being operated by a second person who is providing testing assistance to the user, the meter and lancing device should be decontaminated prior to use by the second person.

Sharing the lancing device and lancets may increase the risk of spreading infectious diseases. Lancing device must not be used on more than one person.

Preparing the Lancing Device for Blood Testing
Please refer to the manufacturer’s instructions for the lancing device to collect a blood sample.

Preparing the Puncture Site
Stimulating blood perfusion by rubbing the puncture site before blood extraction has a significant influence on the test value obtained. Blood from a site that has not been rubbed exhibits a measurably different lactate 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:

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

► Fingertip testing
Hold the lancing device firmly against the lower side of your fingertip. Press the release button to puncture your finger; 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 that you discard the first drop of blood as it might contain tissue fluid, which may affect the test result.

Performing a Lactate Test

1. Insert the test strip to turn on the meter
   Wait for the meter to display “LAC” and “ ”.

2. Obtaining a blood sample
   Use the pre-set lancing device to puncture the desired site. Wipe off the first appeared drop of blood with a clean cotton swab. The size of the drop should be at least 0.8 microliter (μL) for a lactate test. Gently squeeze the punctured area to obtain another drop of blood. Be careful NOT to smear the blood sample.

3. Bring strip to sample
   While holding the meter in an angled position with the strip facing down, gently bring the strip to the sample so that the absorbent hole can sip in the blood. Confirmation window should be completely filled if enough blood sample has been applied. Do NOT remove your finger until you hear a beep sound. 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 within 3 minutes, the meter will automatically turn off. You must remove the test strip and insert it back into the meter 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 drop of blood has moved away. Discard the used test strip and retest with a new one.
    If you have trouble filling the confirmation window, please contact your health care professional or local customer service for assistance.

4. Read your result
   The result of your test will appear after the meter counts down to 0. The result will be stored in the memory automatically.

5. Eject the used test strip
   Eject the test strip by pushing the eject button on the side. Dispose of the used test strip in a sealed trash container or one that’s out of the reach of pets or children. The meter will switch itself off automatically. Take the lancet out carefully. Place the disk on a hard surface and push the exposed tip into the protective disk. When removing the lancet, follow the instructions from the lancing device insert.

WARNING:

• The used lancet and test strip may be biohazardous. Please discard them properly.
• Wash and dry your hands thoroughly after handling the meter, lancing device and test strips to prevent infection. For more information, please refer to the MAINTENANCE section.

METER MEMORY

Your meter stores the 1,000 most recent test results with date and time in its memory. To enter the meter memory, start with the meter switched off.

Reviewing Test Results

1. Press and release the MAIN button “ ” will appear on the display. The first reading you see is the last testing result along with date, time and the  measurement mode.
2.  Press the ◄/► button to recall the test results stored in the meter. Press and hold the MAIN button again and the meter will be turned off.

DOWNLOADING THE RESULTS

Data Transmission via Bluetooth
You can transmit your measurement data from the meter to an App on your mobile device via Bluetooth signal. Please note that you must first pair your meter to your mobile device before attempting to transmit any data. Please contact customer service or the place of purchase for further assistance.

Pairing with your mobile device

1. Start with the meter switched off. Insert a test strip to turn on the meter. Wait for the screen to display “ ” and the Bluetooth indicator starts to flash. Remove and dispose of the test strip. You can also activate Bluetooth function by entering Memory Mode
   when memory is not empty. Press and release the MAIN button to enter the memory mode then the Bluetooth indicator will flash.

2. On your mobile device, turn on the Bluetooth function and follow the instruction on the App to pair the device (e.g., Search for meter, and Pair).

3. After successfully pairing the App to your meter, the Bluetooth function on the meter will then start to transmit the data to your App.

Bluetooth indicator on the meter

NOTE:

• While the meter is in transmission mode, it will be unable to perform a test.
• Make sure that your Bluetooth enabled device has turned on the Bluetooth signal prior to transmitting the data, and that the meter is within range.
• For OS version requirements please refer to the app description on the Apple App Store or Google Play Store.
• A compatibility issue between your mobile device and the meter might occur due to the way Bluetooth functionality is implemented by the various mobile device manufacturers.

MAINTENANCE

Battery
Your meter comes with two 1.5V AAA size alkaline batteries.

Low Battery Signal

The meter will display the message below to alert you when the meter power is getting low.
The “ ” appears with E-b and error:
The power is not enough to do 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 cover and lift it up to remove.
2. Remove the old battery and replace it with two 1.5V AAA size alkaline batteries.
3. Close the battery cover. If the battery is inserted correctly, you will hear a “beep” afterwards.

NOTE:

• Replacing the batteries does not affect the test results stored in the memory.

• As with all small batteries, these batteries should be kept away from children.
  If swallowed, promptly seek medical assistance.

• Batteries might leak chemicals if unused for a long time. Remove the batteries if you are not going to use the device for an extended period (i.e., 3 months or more).

• Properly dispose of the batteries according to your local environmental regulations.

• After replacing batteries, the meter will enter the setting mode.

Caring for Your Meter
To avoid the meter and test strips attracting dirt, dust or other contaminants, please wash hands thoroughly with soap and water before and after use.
What is Cleaning and Disinfection?
Cleaning and disinfection are different. Cleaning is the process of removing dirt (e.g. food debris, grease, dust); disinfection is the process of killing germs (e.g. bacteria and viruses).
When to clean and disinfect the meter?
Clean the meter when you see any dirt on it. You should disinfect the meter at least once a week to prevent infection.
How to clean and disinfect the meter?
The meter must be cleaned prior to the disinfection. Use one disinfecting wipe to clean exposed surfaces of the meter thoroughly and remove any visible dirt or blood or any other body fluid with the wipe. Use a second wipe to disinfect the meter. Do NOT use organic solvents to clean the meter.
We recommend for meter cleaning and disinfection you should use the disinfecting wipe/towelette from below. The following product has been shown to be safe for use with the FORA Test N’GO Advance Voice Lactate Test System.
► Micro-Kill+™ (Micro-Kill Plus™) by Medline
(EPA Reg. No. 59894-10-37549)
To obtain disinfecting wipes and other information, please contact Medline at 1-800-MEDLINE (1-800-633-5463) or visit www.medline.com.

Disinfecting Procedures

1. Wipe all exterior surface display and buttons of the meter by three passes vertically and three passes horizontally with a disinfecting wipe. Be sure to clean the areas around slots and openings, while being careful not to get any excess liquid in them.
2. Disinfect the meter in the same way as cleaning with another disinfecting wipe.
3. Keep the meter surface wet with disinfection solution for a minimum of 2 minutes for Micro-Kill+™ wipes.
4. Dispose the used wipes. Allow the meter surface to dry completely.
5. Discard the used wipes and never reuse them. Wash your hands thoroughly with soap and water after handling the meter, lancing device and test strips to avoid contamination.

Improper system cleaning and disinfection may result in meter malfunction. If you have a question, please contact local customer service 1-888-307-8188 (hours of operation: Mon – Fri, 6:30 am to 5:30 pm PST. For assistance outside these hours, please contact your healthcare provider.
This device has been validated to withstand up to 10950 cleaning and disinfection cycles using the recommended disinfecting wipe/towelette. The tested number of cycles is estimated by 10 cleaning and disinfection cycles per meter per day for 3 years, the expected life of the meter. The meter should be replaced after the validated number of cleaning and disinfection cycles or the warranty period, whichever comes first.
Stop using the meter if you see any signs of deterioration. For example:

• Meter cannot be turned on
• LCD display cracks or becomes cloudy
• Buttons no longer function
• Meter outer casing cracks
• Data cannot be transmitted
• Scratches or abrasions on meter are higher than acceptable
• Color or paint/printing on housing is abnormal

Please contact the customer service for a replacement meter if any of the signs of deterioration are noticed.

NOTE:

• Do NOT clean and disinfect the meter while performing tests.
• If the meter is being operated by a second person, the meter and lancing device should be decontaminated prior to use by the second person.
• Do NOT allow cleaning and disinfecting solution to get in the test slot.
• If you do get moisture in the test strip slot, wipe it away with a corner of tissue.
• Always dry the meter thoroughly before using it.
• Do not spray the meter directly with cleaning solutions especially those containing water (i.e. soapy water), as this could cause the solution to enter the case inside and damage the electronic components or circuitry.

Meter Storage

• Storage conditions: -4°F to 140°F (-20°C to 60°C), 10% to 93% relative humidity.
• Always store or transport the meter in its original storage case.
• Avoid dropping and heavy impact.
• Avoid direct sunlight and high humidity.

Meter Disposal
The used meter should be treated as contaminated that may carry a risk of infection during measurement. The batteries in this used meter should be removed and the meter should be disposed in accordance with local regulations.

Caring for Your Test Strips

• Storage conditions: 35.6°F to 86°F (2°C to 30°C) and between 10% to 85% relative humidity. Do NOT freeze.
• Store test strip packages in a cool dry place. Keep away from direct sunlight and heat.
• Touch the test strip with clean and dry hands.
• 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.
• Do NOT reuse test strips.

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

Cleaning and Disinfecting Your Lancing Device
For home users, the lancing device is reusable. Please disinfect your lancing device regularly and follow the procedures in the Lancing Device Manual.

• Do NOT place the device in a dishwasher or use detergents.

The lancing device should be cleaned after each use.

Important Control Solution Information

• Use only FORA control solutions with your meter.
• Do not use the control solution beyond the expiration date or 3 months after first opening. Write the opening date on the control solution vial and discard the remaining solution after 3 months.
• It is recommended that the control solution test be done at room temperature 68°F to 77°F (20°C to 25°C). Make sure your control solution, meter, and test strips are at this specified temperature range before testing.
• Shake the vial before use, discard the first drop of control solution, and wipe off the dispenser tip to ensure a pure sample and an accurate result.
• Store the control solution tightly closed at temperatures between 35.6°F to 86°F (2°C to 30°C). Do NOT freeze.

SYSTEM 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 yourself and never try to disassemble the meter under any circumstances.

Result Readings

which is less than 0.3 mmol/L.
| Appears when your result is higher than the limit of measurement, which is higher than 22 mmol/L.

Error Messages

Replace the batteries immediately.
E-2| Expired code strip.| Repeat the test with a new lot of test strip.
E-U| Appears when a used test strip is inserted.| Repeat with a new test strip.
E-E
E-0
EA| Problem in operation.| Repeat the test with a new test strip. If the meter still does not work, please contact the customer service for assistance.
E-F| Appears when test strip is removed while counting down.| Repeat the test with a new test strip.
E-C| Appears when the wrong code strip is inserted or other coding errors.| Make sure to insert the right code strip for the meter.
Check if the code numbers on the code strip and the strip vial label or individual foil package are the same.
E-t| Appears when ambient temperature is below or above system operation range.| System operation range is 50°F to 104°F (10°C to 40°C), 10% to 85%. Repeat the test after the meter and test strip are in the above temperature range.

Troubleshooting

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

contact bars end first and facing up.
Defective meter or test strips.| Please contact customer service.

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

Sample applied after automatic switch-off (3 minutes after last user
action).| Repeat the test with a new test strip.
Apply sample only when flashing “ ” appears on the display.
Defective meter.| Please contact customer service.

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

test again.
Control solution vial was poorly shaken.| Shake the control solution vigorously and repeat the test again.
Expired or contaminated control solution.| Check the expiration date of the control solution.
Control solution that is too warm or too cold.| Control solution, meter, and test strips should be at room temperature (68°F to 77°F / 20°C to 25°C) before testing.
Defective test strip.| Repeat the test with a new test strip.
Meter malfunction.| Please contact customer service.

DETAILED INFORMATION

Reference Values

The meter provides you with plasma equivalent results and are displayed in millimoles of lactate per liter of blood (mmol/L).
Desirable range:

Source: Mary A. Williamson, L. Michael Snyder, 10th ed, 2015. Wallach’s interpretation of diagnostic test:pathways to arriving at a clinical diagnosis.
Philadelphia:Wolters Kluwer.
Please consult your doctor to determine a target range that works best for you.

SPECIFICATIONS

Model No. : FORA Test N’GO Advance Voice
Dimension: 90.5 (L) x 55.14 (W) x 20.9 (H) mm
Weight: 50.2 g (without battery)
Power Source: two 1.5V AAA alkaline batteries
Display: LCD
Memory: 1,000 measurement results with date and time
External Output : Bluetooth
Automatic detection of electrode insertion
Automatic reaction time count-down
Temperature warning
Auto turn-off after 3 minutes without action

Operating Condition:
50°F to 104°F (10°C to 40°C), 10% to 85% R.H. (non-condensing)
Meter Storage/Transportation Conditions:
-4°F to 140°F (-20°C to 60°C), 10% to 93% R.H. (non-condensing)
Test Strip Storage / Transportation Conditions:
35.6°F to 86.0°F (2°C to 30°C), 10% to 85% R.H. (non-condensing)
Measurement Units: mmol/L
Measurement Range: 0.3 ~ 22 mmol/L
Sample Volume: 0.8 μL
Hematocrit Range: 10% to 65%
Reaction Time: 5 seconds
Operating Altitude: Up to 3500m, for indoor use.
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, and EN 61326-2-6.

FEDERAL COMMUNICATIONS COMMISSION (FCC) STATEMENT

15.21
You are cautioned that changes or modifications not expressly approved by the part responsible for compliance could void the user’s authority to operate the equipment.
15.105(b)
Federal Communications Commission (FCC) Statement
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, may 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 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 and
2. This device must accept any interference received, including interference that may cause undesired operation of the device.

FCC RF Radiation Exposure Statement:

1. This transmitter must not be co-located or operating in conjunction with any other antenna or transmitter.
2. When used with an accessory that contains metal may not ensure compliance with FCC RF exposure guidelines.

For Self-Testing. Read instructions before use.
Distributed by ForaCare, Inc.
893 Patriot Drive Suite Drive, Moorpark, CA 93021 USA
Products made in Taiwan
Toll Free: 1-888-307-8188
(6:30 am-5:30 pm PST, Monday to Friday)
For assistance outside of these hours, please contact your healthcare professional.
www.foracare.com

References

• prueba.de - This website is for sale! - prueba Resources and Information.
• CDC Clinical Reminder: Use of Fingerstick Devices on More than One Person Poses Risk for Transmitting Bloodborne Pathogens | Injection Safety | CDC
• ForaCare – The New Leader in Medical Device Technology
• Archive-It Wayback Machine

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