ForaCare FORA 6 Plus Installation guide

Version: Rev 5.4
Release date: 5 Aug. 2022
Editor: Joey Yang
ForaCare Suisse AG
Blood Glucose and Multi-Functional
Monitoring System FAQs

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Table of contents
Troubleshooting 4
Q1. Troubleshoot abnormal results and error messages................................. 4
Power 5
Q2. How long will my battery last?................................................................... 5
Q3. Would low battery cause inaccurate test results?...................................... 5
Q4. Would replacing the battery cause memory loss?..................................... 5
Q5. Why does my meter display a battery symbol?......................................... 5
General Blood Glucose Questions 6
Q6. Which test strips go with my FORA BGM?................................................ 6
Q7. What do I need to know before using FORA’s BGMs?............................ 10
Q8. Why do I need to code my meter before use, and how? ......................... 11
Q9. Ｗhat situations may cause incorrect measurements?............................ 12
Q10. How do I know if sufficient blood has been applied to the test strip?....... 13
Q11. What does the clinical validation on FORA’s BGMs mean? .................... 13
Q12. Why do I get different results in successive measurements using the same
meter?..................................................................................................... 14
Q13. What are the precautions for lancing devices?........................................ 15
Q14. What is Alternative Site Testing (AST)?.................................................. 15
Q15. Which testing sites can be used with FORA’s BGMs? ............................ 16
Q16. When do I use AST?............................................................................... 16
Q17. What is a ketone warning?...................................................................... 17
Q18. Can hematocrit levels affect the result? .................................................. 17
Caring for Your Devices 18
Q19. When should I clean and disinfect my FORA BGM?............................... 18
Q20. How do I clean my FORA BGM?............................................................. 18

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Q21. How do I clean my lancing device?......................................................... 18
Q22. How do I dispose of my FORA BGM?..................................................... 18
Test Strips 19
Q23. What do FORA test strips offer?.............................................................. 19
Blood Glucose Test Strips 19
3 in 1 (BG/HCT/HB) Test Strip 20
β-Ketone (KB) Test Strip 20
Uric Acid (UA) Test Strip 21
Total Cholesterol (TCH) Test Strip 21
Q24. Can I use the FORA’s test strips on an airplane?.................................... 22
Q25. Can I use FORA’s test strips if I am on oxygen therapy? ........................ 22
Control Solution 23
Q26. How do I do control solution tests?.......................................................... 23
Q27. Where can I find the control solution range?........................................... 24
Q28. Why didn’t my control solution test results fall into the range provided? . 24
Universal Tone 25
Q29. What is universal tone, and which devices have this function?............... 25
Q30. How do I interpret the universal tone?..................................................... 26
Q31. How does universal tone recall results?.................................................. 27
Data Management 28
Q32. What are the platforms for blood glucose management?........................ 28
Q33. What are the supported operating systems in FORA Healthcare system
software?................................................................................................. 29
Q34. How do I switch the blood glucose unit in iFORA BG?............................ 30
Q35. What does Bolus Calculator do in iFORA HM?....................................... 31
Q36. What is the difference between Bluetooth V3 and V4? ........................... 33
Q37. How do FORA BGMs transmit data and manage media?....................... 34

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Troubleshooting
Q1. Troubleshoot abnormal results and error messages
Situation
Root Cause
Solution
A significant
fluctuation between
measurements.
(1) Using old or expired test strips.
(2) The blood samples were
obtained from different sites
each time.
(3) Waited too long to insert the test
strip.
(4) The blood samples are
contaminated. (e.g. the pricked
site is not clean)
(1) The strips could be expired or
malfunctioned due to improper
storage.
Please use new strips within the
expiry date.
(2) Please obtain blood samples from
the same site.
(3) Please insert the test strip as
soon as you collect a blood
sample.
(4) Make sure your hands are clean
before testing.
Higher results than
usual
(1) Excess plasma in the blood
sample from excessively
squeezing the fingertip.
(2) The test strip has expired or was
affected by temperature and
humidity.
(3) Patient’s health conditions:
a. Medications.
b. Time and dosage of insulin
administered.
c. HCT level.
d. Interference factors in the diet,
such as vitamin C (ascorbic
acid), glutathione (antioxidant),
and uric acid (for GDH strips).
e. Patient Hydration level.
(1) Conduct the test again. Do not
excessively squeeze the pricked
site. We recommend wiping off
the first drop of blood to avoid
effusion tissue fluid.
(2) Please open a vial within the
expiry date and do the test again.
(3) Please check with your doctor to
make sure your status is suitable
for measuring blood glucose
without any interference.
Error: E-U/ Err 24
(1) Inserted a used test strip.
(2) The blood sample was inserted
before the blood drop symbol.
Repeat the test with a new test strip.
Wait for the “blood drop”symbol to
blink, then apply a proper amount of
blood.
Error: E-b/ Err 36
The battery is too low.
Replace or charge the batteries.
Error: E-F
The strip was removed too soon
after applying the blood.
Repeat the test with a new test strip
and wait for the result.
The BGM keeps
beeping until it is out
of the battery.
The Electronic component is
defective in PCBA.
Please contact FORA customer
service for repair or replacement.

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Power
Q2. How long will my battery last?
Depending on which FORA device you own, the BGMs provide a battery life of
600 to 1000 measurements. The battery’s lifespan can vary considerably by how it is
used, maintained, and charged. Temperature and testing frequency are also
important factors.
Q3. Would low battery cause inaccurate test results?
FORA meters provide accurate test results even on low batteries.
Q4. Would replacing the battery cause memory loss?
No, replacing the battery does not affect the test results stored in the memory.
Q5. Why does my meter display a battery symbol?
It means battery power is extremely low when the “ &E-b”symbol appears on
the screen. You need to charge or replace the battery immediately.
The detailed explanations about the battery capacity areas the following stages:
1. Low battery symbol: 30％.
2. E-b on display (turn off automatically): 20％.
3. No reaction when turning on: 10％.
4. Dead battery: ＜10％

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General Blood Glucose Questions
Q6. Which test strips go with my FORA BGM?
1. FORA 6 Series
FORA 6 Plus
(GD81)
FORA 6 Connect
(GD82)
FORA 6 GTel
(GD84)
FORA 6
BG Strip
(ACS045)
FORA 6
BG/HCT/HB
(3 in 1) Strip
(ACS051)
FORA 6
β- Ketone Strip
(ACS053)
FORA 6
Uric Acid Strip
(ACS057)
FORA 6
Total Cholesterol
Strip
(ACS055)

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2. FORA Diamond Series
FORA Diamond PRIMA
(DM10)
FORA Diamond VOICE
(DM20)
FORA Diamond
BG Strip
(ACS044)
FORA Diamond MINI
(DM30ab)
FORA Diamond GD50
(GD50ab)

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3. FORA ADVANCED pro Series
FORA ADVANCED pro
(GD40g/h)
FORA ADVANCED pro
BG Strip
(ACS047)
FORA ADVANCED pro
β- Ketone Strip
(ACS052)

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4. FORA COMFORT Series:
FORA COMFORT
basic
(G20)
FORA COMFORT
plus
(G30a)
FORA COMFORT
plus mini
(G71a)
FORA COMFORT
check
(G40)
FORA COMFORT
basic
BG Strip
(ACS041)
FORA COMFORT
BG Strip
(ACS042)
FORA COMFORT
check
BG Strip
(ACS043)

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Q7. What do I need to know before using FORA’s BGMs?
1. The β-Ketone, total cholesterol, and uric acid test strips shall NOT be used on
newborns.
2. Use the devices ONLY for the intended use described in the manual.
3. For single use only.
4. Do NOT use expired test strips; the results might be inaccurate. The expiration
date is printed on every vial (or foil).
5. Do NOT use accessories that are not specified by the manufacturer.
6. Do NOT use the device if it is not working properly or is damaged.
7. The 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.
8. Before using the device to test blood glucose, BG/HCT/Hb,β-Ketone, total
cholesterol, and uric acid, read all instructions thoroughly and practice the test.
9. Keep the device and testing supplies away from young children. Small items
such as the battery cover, batteries, test strips, lancets, and vial caps are
choking hazards.
10. Using the device while synthetic materials are present (synthetic clothing,
carpets, etc.) may cause damaging static discharges that cause erroneous
results.
11. Do NOT use this instrument near sources of strong electromagnetic radiation, as
these may interfere with the correct operation.
12. Proper maintenance and storage are essential in ensuring the longevity of your
device. If you are concerned about the accuracy of the measurement, please
contact the place of purchase or customer service representative for assistance.

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Q8. Why do I need to code my meter before use, and how?
FORA’s devices do not need coding except for special strips: β-Ketone, Urine
Acid, and Total Cholesterol test strips.
You would need to code the meter every time you begin to use a new vial of β-
ketone, Total cholesterol, and Uric acid test strips by setting the meter with the
correct code. Be careful that test results may be inaccurate if the code number
displayed on the monitor does not match the number printed on the strip label or strip
foil pack.
Procedure:
(1) Insert the code strip into the test slot of the device. Wait for the device to display
the code number.
(2) Make sure the numbers on the display, code strip, and test strip vial or foil pack
are the same. The code strip should be within the expiry date; otherwise, an error
message may appear.
(3) Remove the code strip. The display shows “OFF”, telling that the meter has
finished coding and is ready for β-ketone/ Total cholesterol/ Uric acid testing.

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Q9. Ｗhat situations may cause incorrect measurements?
1. Using other substances to perform a test can lead to incorrect results. Please use
only fresh whole blood samples.
2. Results may be inaccurate when you have abnormally low blood pressure or are
in shock.
3. Severe dehydration and excessive water loss may cause lower glucose values. If
you believe you are suffering from severe dehydration, consult a healthcare
professional immediately.
4. Readings that 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.
5. A high concentration of acetaminophen, bilirubin, hemoglobin, methyldopa, and
ascorbic acid in uric acid measurement may affect the test results.
6. The user is suggested to perform a uric acid test in the morning after fasting for
12 hours.
7. In total cholesterol measurements, there is no significant interference in the
presence of methyl DOPA, acetaminophen, uric acid, dopamine, gentistic acid,
ascorbic acid, ibuprofen, salicylate (when at physiological or therapeutical levels).
Glucose levels up to 476 mg/dL (13.89 mmol/L) also do not affect the results
significantly.
8. Use ONLY heparin for anticoagulation of whole blood samples. Please do NOT
use EDTA for anticoagulation.

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Q10. How do I know if sufficient blood has been applied to the test
strip?
If insufficient blood is applied, an error beep occurs, and an error code appears on
the screen (please refer to the Owner’s Manual and check error messages.) Please
review the instructions and repeat the test with a new test strip.
To ensure enough blood has been applied, the front side of the test strip should
face up when inserting the test strip. Test results might be wrong if the contact bar is
not fully inserted into the test slot.
Absorbent Hole
Apply a drop of blood here.
The Blood will be
automatically absorbed.
Confirmation Window
This is where you confirm
if enough blood has been
applied to the absorbent
hole in the strip.
Test strip Handle
Hold this part to insert the
test strip into the slot.
Contact Bars
Insert this end of the test
strip into the meter. Push it
in firmly until it will go no
further.
Q11. What does the clinical validation on FORA’s BGMs mean?
The clinical validation is a testament to the accuracy of FORA’s blood glucose
monitors. The glucose testing value should comply with the international standard:
EN ISO 15197:2015
Analytical performance evaluation 95% of the measurement to fall:
±15mg/ dL at glucose concentrations＜100mg/ dL (＜5.55mmol/L)
±15% at glucose concentrations≧100mg/ dL (≧5.55mmol/L)

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Q12. Why do I get different results in successive measurements
using the same meter?
(1) Test strip problems:
A. Test strip expired
B. Test strip contaminated or damaged
C. Not enough blood applied to the test strip
(2) Meter problems:
A. The meter is damaged.
B. Wrong code between test strip and meter
C. Unknown electronic elements defect
(3) The blood sampling surface is not clean, make sure to wash your hands before
doing a test.
(4) Improper blood obtaining:
A. Excessively squeezing your finger can cause too much tissue fluid in the
blood samples and get the wrong measuring value.
B. If you are using a site other than your fingertip and you think the reading is
wrong, test again using blood from a fingertip. Blood samples from alternate
sites are not as accurate as fingertip samples when your blood sugar level is
rising or falling quickly.
(5) Extreme temperatures or humidity:
A. Keep your glucose meter and test strips at proper operating temperature
and humidity based on the Owner’s manual in each meter and strip.
(6) The number of red blood cells in your blood:
A. If you are dehydrated or your red blood cell count is low (anemia), your test
results may be less accurate. Please refer to the Owner’s manual and
consult a doctor to check the suitable hematocrit range for testing.

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Q13. What are the precautions for lancing devices?
1. Never share a lancet or a lancing device.
2. Always use a new, sterile lancet. Lancets are for single use only.
3. Avoid getting hand lotion, oils, dirt, or debris in or on the lancets and the lancing
device.
4. The used lancet may potentially be biohazardous. Discard it according to your
local regulations.
Q14. What is Alternative Site Testing (AST)?
Alternative site testing (AST) refers to measuring of blood glucose levels using
body areas other than the fingertips. The FORA test strips allow AST to be performed.
Please consult your health care professional before performing AST.

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Q15. Which testing sites can be used with FORA’s BGMs?
1. Home use
(1) Fingertips (capillary), palm, forearm, and upper arm blood are the alternative
testing sites in FORA’s glucose and BG/HCT/HB (3 in 1) test strips.
(2) Fingertips (capillary) blood is the only testing site in β-Ketone, urine acid, and total
cholesterol test strips.
2. Professional use
(1) Arterial blood can only be used on FORA 6 blood glucose test strips and FORA 6
BG/HCT/HB (3 in 1) test strips.
(2) Venous and capillary blood can be used on FORA’s all blood glucose,
BG/HCT/HB (3 in 1), β-Ketone, urine acid, and total cholesterol test strips.
Q16. When do I use AST?
We strongly recommend that you use AST ONLY at the following times:
•During 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:
•You think your blood glucose is low.
•You may not notice if you are hypoglycemic.
•Your AST results are inconsistent with the way you feel.
•You are testing for hyperglycemia.
•Your routine glucose results often fluctuate.

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Q17. What is a ketone warning?
When your blood glucose result is higher than 240 mg/dL (13.3 mmol/L), the
meter displays the blood glucose reading as well as a Ketone warning (flashing
KETONE and” ”). The ketone warning is to notify you that you may be at risk of
elevated Ketone levels, and a Ketone test is recommended.
Q18. Can hematocrit levels affect the result?
Hematocrit levels can affect results whether the sample is obtained from a
forearm or a finger stick. You should refer to the specification of each BGM’s
Hematocrit tolerance range. For example, suppose the meter’s hematocrit tolerance
range is 30% to 55%. In that case, hematocrit levels less than 30% may cause falsely
high readings, and hematocrit levels greater than 55% may cause falsely low
readings. If the patient does not know their hematocrit level, they should consult their
health care professional.

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Caring for Your Devices
Q19. When should I clean and disinfect my FORA BGM?
Clean your meter once a week or any time blood gets on the meter. You should
also clean the meter before letting anyone else handle it.
Q20. How do I clean my FORA BGM?
To clean the exterior and the areas around the slots and openings of the device,
wipe with a cloth moistened with tap water or a mild cleaning agent, then dry the
device with a soft dry cloth.
Note:
Do NOT rinse with water.
Do NOT use organic solvents to clean the device.
Q21. How do I clean my lancing device?
1. Use mild soap and water to clean the lancing device.
2. DO NOT rinse the device with water.
3. Disinfect the cap by placing it in 70% alcohol for 10 minutes, and air dry it.
4. Do NOT place the device in a dishwasher or use detergents.
Q22. How do I dispose of my FORA BGM?
A used meter should be treated as contaminated and may cause infection during
measurements. The batteries in a used meter should be removed, and the meter
should be disposed of following local regulations. Please refer to the local regulations
to discard the used blood glucose meter before removing batteries.

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Test Strips
Q23. What do FORA test strips offer?
Blood Glucose Test Strips
FORA 6
(ACS045)
Applicable Meters:
FORA 6 Plus/ Connect/ GTel
Enzyme Type: GDH-FAD
Sample Size: 0.5 uL
Reaction Time: 5 Seconds
Hematocrit Range: 0 ~ 70%
Measuring Range:
10 ~ 600 mg/dL
(0.55 ~ 33.3 mmol/L)
Alternative Site Testing:
Yes AST
Applicable Sample:
Capillary, Venous, Arterial
Intended Use: General Patient;
Dialysis; Gestational; Neonatal
Code Type: No code card
FORA
Diamond
(ACS044)
Applicable Meters:
FORA Diamond PRIMA/ VOICE/
MINI/ GD50
Enzyme Type: GDH-FAD
Sample Size: 0.5 uL
Reaction Time: 5 Seconds
Hematocrit Range: 20 ~ 60%
Measuring Range:
20 ~ 600 mg/dL
(1.1 ~ 33.3 mmol/L)
Alternative Site Testing:
Yes AST
Applicable Sample:
Capillary, Venous
Intended Use: General Patient;
Dialysis; Gestational
Code Type: No code card
FORA
ADVANCED
pro
(ACS047)
Applicable Meters:
FORA ADVANCED pro
Enzyme Type: GDH-FAD
Sample Size: 0.8 uL
Reaction Time: 5 Seconds
Hematocrit Range: 0 ~ 70%
Measuring Range:
10 ~ 600 mg/dL
(0.55 ~ 33.3 mmol/L)
Alternative Site Testing: No AST
Applicable Sample:
Capillary, Venous
Intended Use: General Patient;
Dialysis; Gestational; Neonatal
Code Type: No code card
FORA
COMFORT
(ACS042)
Applicable Meters:
FORA COMFORT plus/ plus mini
Enzyme Type: GOD
Sample Size: 0.5 uL
Reaction Time: 5 Seconds
Hematocrit Range: 20 ~ 60%
Measuring Range:
20 ~ 600 mg/dL
(1.1 ~ 33.3 mmol/L)
Alternative Site Testing:
Yes AST
Applicable Sample: Capillary
Intended Use: General Patient
Code Type: No code card
FORA
COMFORT
basic
(ACS041)
Applicable Meters:
FORA COMFORT basic
Enzyme Type: GOD
Sample Size: 0.7 uL
Reaction Time: 7 Seconds
Hematocrit Range: 20 ~ 60%
Measuring Range:
20 ~ 600 mg/dL
(1.1 ~ 33.3 mmol/L)
Alternative Site Testing:
Yes AST
Applicable Sample: Capillary
Intended Use: General Patient
Code Type: No code card
FORA
COMFORT
check
(ACS043)
Applicable Meters:
FORA COMFORT check
Enzyme Type: GDH-FAD
Sample Size: 0.7 uL
Reaction Time: 7 Seconds
Hematocrit Range: 35 ~ 60%
Measuring Range:
20 ~ 600 mg/dL
(1.1 ~ 33.3 mmol/L)
Alternative Site Testing:
Yes AST
Applicable Sample:
Capillary, Venous
Intended Use: General Patient
Code Type: No code card

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3 in 1 (BG/HCT/HB) Test Strip
FORA 6
(ACS051)
Applicable Meters: FORA 6 Plus/ Connect/ GTel
Enzyme Type: GDH-FAD
Sample Size: 0.5 uL
Reaction Time: 5 Seconds
Hematocrit Range: 0 ~ 70%
Measuring Range:
BG: 10 ~ 600 mg/dL(0.55 ~ 33.3 mmol/L)
HCT: 0 ~ 70%
Hb: 0~23.8 g/dL
Alternative Site Testing: Yes AST
Applicable Sample: Capillary; Venous; Arterial
Intended Use: General Patient; Dialysis; Gestational; Neonatal
Code Type: No code card
β-Ketone (KB) Test Strip
FORA 6
(ACS053)
Applicable Meters: FORA 6 Plus/ Connect/ GTel
Enzyme Type: β- Hydroxybutyrate
Sample Size: 0.8 uL
Reaction Time: 10 Seconds
Hematocrit Range: 10 ~ 70%
Measuring Range: 0.1~8.0mmol/L
Alternative Site Testing: No AST
Applicable Sample: Capillary; Venous
Intended Use: General Patient
Code Type: Need code card
FORA
ADVANCED
pro
(ACS053)
Applicable Meters: FORA ADVANCED pro
Enzyme Type: β- Hydroxybutyrate
Sample Size: 1.0 uL
Reaction Time: 10 Seconds
Hematocrit Range: 10 ~ 70%
Measuring Range: 0.1~8.0 mmol/L
Alternative Site Testing: No AST
Applicable Sample: Capillary; Venous
Intended Use: General Patient
Code Type: Need code card