FORA A1C100 Hemoglobin A1c Analyzer Instruction Manual

: June 4, 2024
: FORA

Table of Contents

IMPORTANT INFORMATION
SAFETY INFORMATION
INTRODUCTION
MAINTENANCE
SYMBOL INFORMATION
SPECIFICATIONS
Documents / Resources

Hemoglobin A1c Analyzer
Operation Instruction
Version 2.0 2021/10
541-4611100-021

IMPORTANT INFORMATION

The measurement unit used for indicating the concentration of HbA1c can be either NGSP unit(%), IFCC unit(mmol/mol), or Estimated Average Glucose(mg/dL). The approximate calculation rule for conversion is:

%	10.93 x HbA1c(%) – 23.5	= mmol/mol
%	28.7 x HbA1c(%) – 46.7	= mg/dL

For example;

7% x 10.93 – 23.5= 53 mmol/mol
7% x 28.7 – 46.7= 154 mg/dL
Source: “National Glycohemoglobin Standardization Program (NGSP)” website
http://www.ngsp.org/bground.asp

SAFETY INFORMATION

WARNING!
A warning statement in this manual identifies hazards that could lead to personal injury. These warnings pertain to the entire FORA A1C100 Hemoglobin A1c Analyzer.
CAUTION!
A caution statement in this manual identifies hazards that could lead to product damage or data loss.

IMPORTANT SAFETY INSTRUCTIONS

READ BEFORE USE

Use this device ONLY for the intended use described in this manual.
FORA A1C100 is designed for medical clinician use, only a trained clinician or professional user should use this device.
Do NOT use accessories that are not specified by the manufacturer.
Do NOT use the equipment in places where aerosol sprays are being used. Sprays will permanently damage the optical system.
Do NOT use this device in close proximity to sources of strong electromagnetic radiation, as these may interfere with the accurate operation.
Do not let the device or its flexible cord come into contact with surfaces that are too hot to touch.
Handle the device with extreme care. Severe mechanical shocks can damage the internal parts.
Allow at least 3 cm of air space between the wall and the back of the device in order not to block ventilation, and prevent the power connector from damage.
Every six months, replace the fan filter with a new one.
Do not open the cover during the measuring process due to the rotation of the internal device may cause personal injury or device damage.
Keep the hands away from the inner side of the device, and do not let any liquid or object get into the inner side of the device.
While reloading or replacing the thermal paper, the induction surface of the paper roll should be faced up before printing.
Always operate the device in an operating temperature range 15°C to 32°C (59°F to 89.6°F), and with relative humidity less than 90%.
Always store the device in a cool and dry place: temperatures between 10°C to 35°C (50°F to 95°F) with relative humidity less than 90%. Avoid direct sunlight.

INTRODUCTION

Intended Use
The analyzer is designed to quantitatively measure the percent of glycated hemoglobin (HbA1c %) levels in capillary or venous whole blood samples. Due to its small size and easy operation, it is ideal for professional use in physician office laboratories and diabetes clinics. Test performed using the HemoglobinA1c Analyzer is intended for in vitro diagnostic use. As with all diagnostic tests, do not base a definitive diagnosis on the results of a single test. A physician should make a diagnosis after all clinical and laboratory
findings are evaluated.

Contents of FORA A1C100 System

HbA1c Analyzer
Power Supply: SINPRO Model No.:MPU31-104, INPUT: 100-240V~47-63Hz,
OUTPUT: 10V ****3A
Thermal Paper

Analyzer Overview

Cover
Reagent Cartridge Compartment
Onboard Printer Cover
Power Switch
DC Adapter Port
USB Type A
USB Type B *
Handhold Area
Activated Button for Printer Cover
Display Screen
Upper-left Button
Middle-left Button
Lower-left Button (Power Button)
Upper-right Button
Middle-right Button
Lower-right Button
Filter Cover *

NOTE:

As to USB Type B, which is without any function for the lay user, it’s required by the manufacturer for internal production use.
It is recommended to replace the fan filter on the bottom of the analyzer with a new one every six months.

Display Screen
The screen displays several indicators to help you use this analyzer. The seven modes below will display on the main page.

Indicator	Meaning/ You can do this
Measure Mode:

Perform HbA1c tests and edit the current test information, e.g. Operator ID, User ID, and Comments.
| QC Mode:
Perform control solution tests and edit the current test information, e.g. Operator ID, QC Lot, and Test Range for Level 1 and Level 2.
| Record Mode:
Review the HbA1c test records in the analyzer and view the records of patients by entering patient ID and date range.
| Setting Mode:
Set up the analyzer such as date, time, and unit of measurement.
| Cal Card Mode:
Import the lot information for each new box of cartridge by calibration card.
| Training Mode:
Video introduce the procedure of HbA1c measurement with both sample preparation and analyzer operation.
| About Mode:
Display the serial number, software, and hardware version of meter.

BEFORE MEASUREMENT – CONNECTING POWER & STARTING THE SYSTEM

Ensure the power switch is in off position “O”. Connect the DC adapter power cord to the system and to an appropriate, grounded AC electrical outlet. After the system is properly installed, turn the power switch on the position “I”, and press the lower-left button to initiate the system. The system performs a self-test to verify that the internal mechanical system with time fetch is operating correctly and warm up the system so it is ready for use. If the time fetches errors, a warning with Time error displays on the screen. Press “ ” to enter Time & Date setting. After operating Time & Date setting, the system completes its initialization and warming up, the main page will display seven modes on the screen and you can start to perform the test.

CAUTION!
Ensure the cover is closed while initiating the system.
WARNING!
Ensure the operating temperature is between 15°C and 32°C (59°F to 89.6° F) in order to get the most accurate test results, or erroneous results may occur.
NOTE:

Make sure the cartridge compartment is “Empty” before starting the test.
Keep pressing the Lower-left Button (Power Button) for 4 seconds, and the analyzer will go to the status of Power Off.
Alarm and error messages will be shown while the ambient temperature is out of the range 15°C and 32°C (59°F to 89.6°F). Place the analyzer and reagent cartridge in the above temperature range for a period of time. After the balance of temperature, press “return” to re-perform the test; Also, while the analyzer is moved from the surroundings in a higher or lower temperature, place the analyzer in the above temperature range for a period of time for the balance of temperature.

Import the lot information for each new box of cartridge by calibration card

Press “Enter” to select cal card mode.
Open the cover, then insert the calibration card and lean the card against the left side. (Do not move or take out the calibration card during reading.)

NOTE:

Do not insert any other metal into the cartridge compartment together with the calibration card.
If the error of Incorrect Calibration Data occurred, please contact the local customer service for help.
When Lot Information was shown on the screen, then take out Calibration Card. Make sure to check the lot number displayed on the screen matches the number on the calibration card.
Press “Confirm” to save the lot information.
NOTE:
If the calibration is interrupted or failed, please take out the calibration card first, press “Cancel”. Then the system will return to the main page and repeat it again.
The analyzer will return to the main page automatically.

PERFORMING THE HBA1C TEST

Opening the Foil Package
Always wear gloves when performing tests.

Remove one foil package (containing a reagent cartridge).
If the reagent cartridge is removed from refrigerated storage, make sure to
warm it up at room temperature for 15 minutes.
Open the foil package.
CAUTION!
Do not use scissors to cut open the foil package. Scissors can damage the reagent cartridge, the flexible plastic pull-tab on the cartridge, or the desiccant bag.
Remove the reagent cartridge from the foil pouch.
CAUTION!
When handling the reagent cartridge, do not touch or otherwise contaminate the optical window or erroneous test results may occur.

Preparing Patient Samples

Clean the finger stick with alcohol swab and let it dry.
Prick the finger stick with lancing device.
Gently squeeze the finger to assist the flow of blood.
Pull up the capillary from the cartridge.
Hold the capillary holder at an angle.
Touch only the tip of the capillary to the blood drop. Blood will automatically flow into the capillary.
CAUTION!
Too much or less amount of blood, erroneous test results may occur.
Less or equal to 0.2 μL of blood is required to fill the capillary.
CAUTION!
When the capillary is filled with the sample, the analysis must begin immediately (Avoid blood clotting)

Inserting Capillary Holder into Reagent Cartridge
Carefully insert the capillary holder into the reagent cartridge until the holder gently snaps into place (will hear a click).
CAUTION!
Avoid harsh insertion of the capillary holder. Do not dislodge the sample from the glass capillary or erroneous results may occur.
NOTE:
If the reagent cartridge is damaged or the flexible pull tab is loose or missing, please discard it and replace it with a new one.
Selecting Measure Mode
Inserting the Reagent Cartridge into the System
CAUTION!
Do not pull the tab, before you insert the reagent cartridge into the cartridge compartment or erroneous results may occur.

Open the cover at a tilted angle for 120 degrees until a click is heard or felt. The bolts inside the device structure will be fastened to fix the cartridge in the right position while insertion.
NOTE:
If not open the cover 120 degree, the cover may be closed again or the cartridge may be in malposition while insertion, which may lead to the device being damaged in operation. Below warning label is stuck on the device for your information.
Hold the reagent cartridge with the label facing left.
NOTE:
The cartridge is designed to fit only one way into the system. Do not force the cartridge into the system.
Insert the reagent cartridge into the cartridge compartment until a gentle snap is heard or felt.
Using a smooth, slow, continuous motion, pull the flexible pull tab completely out of the reagent cartridge.
NOTE:
Make sure the blood sample in the capillary holder is inserted and pull the flexible pull tab.
Press “Enter” to select measure mode.
Press “Confirm” to confirm cartridge insertion.
Close the cover, then start measuring.

NOTE:
During the mesurement, you can press “return” to stop the measurement and return to the previous page.

WARNING!
Do not open the cover during the measuring process due to the rotation of the internal device may cause personal injury or device damage. The operation of the device will be suspended immediately once the cover is open, then the measuring will be forced to stop.

NOTE:
Make sure DO NOT OPEN COVER while in the following conditions:

Initiating the system
In measuring process
In operation process

Enter Patient ID & Operator ID information
During measuring, the system will show the percentage of completed Patient information that can only be entered during measurement. Entering the information will not interrupt the processing. Both letters and numbers can be entered.

Enter Patient ID & Operator ID information by pressing “Edit”.
Edit HbA1c information: Patient ID, Operator ID, Comments.
Move the keyboard current position to left direction.
Move the keyboard current position to down direction.
Confirm the current input character.
Save information.
Back to edit HbA1C information view. You can also use a barcode reader or keyboard to enter the information.
When the test was finished, the test result will display, and the result will be automatically recorded.
You can press “Print” to print a copy of measurement.
The measurement unit can be switched by pressing either “%” or “mmol/mol”.
You can press “PCL” to transmit data via bluetooth dongle.
Remove the used cartridge and the analyzer will return to the main page automatically.

Selecting QC Mode

Press “Enter” to select QC mode.
See the label on the current control solution vial to select Level 1 or Level 2. An animation for the control solution test plays automatically on the screen.
Follow the instructions in the control solution insert to perform the control solution test correctly.
During testing, the system will show the percentage of completion. Entering the information of Operator ID, QC Lot, and Test Range will not interrupt the processing. Both letters and numbers can be entered.
NOTE:
See the label on the current control solution vial to enter the Test Range.
When the test was finished, the QC test result will display, and the result will be automatically recorded.
Remove the used cartridge and the analyzer will return to the main page automatically.
NOTE:
If the control solution testing result is out of the range, please contact the local customer service for assistance.

Selecting Record Mode

How to do

Press “Enter” to select record mode.
Five modes can be selected:
Last 10, All, Patient ID, Date Range, and QC.

“Last 10” and “All”

Enter “Last 10” or “All”.
Select the result you want to review.
Press “Print” to print a copy of the patient test result if necessary.
Press “Delete” to delete the patient test result if necessary.

Patient ID

Select Patient ID.
Enter the patient ID you want to review.
Press “Search”. The search result will display. Select the result you want to review.
Press “Print” to print a copy of the patient test result if necessary.
Press “Delete” to delete the patient test result if necessary.

Date Range

Select “Date Range”
Enter the time period you want to review
Press “Search”. The search result will display. Select the result you want to review
Press “Print” to print a copy of the testing result if necessary
Press “Delete” to delete the testing result if necessary.
“No record” will appear, indicating that there are no test results in the memory.

QC

Select “QC”.
Select the result you want to review.
Press “Print” to print a copy of the QC test result if necessary.
Press “Delete” to delete the QC test result if necessary.

Selecting Setting Mode
How to do

Press enter to select setting mode.

Setting the Date & Time
Use the Right/Down arrows to select the Year, Month, Day, Hour, and Minut2. Use the + and – arrows to change the Year, Month, Day, Hour, and Minutes.
Time & Date format:
• YYYY/MM/DD
• Hour： Min
Press “Return” to save the setting, then return to setting mode.

NOTE:
To keep the date and time settings:

Always connect the power cord to the analyzer and plug it into a functioning wall outlet.
Always keep the power switch on (1).

Setting the HbA1c Unit

Use the down arrows to select % or mmol/mol.
Press “Return” to save the setting, then return to setting mode.

Setting the Export Data

Use the down arrows to select “USB Flash” or “Bluetooth”.
NOTE:
The inner existing data will be overwritten while exporting data by the storage device. It is important to complete the data export and import in sequence. Meanwhile, do not export data from several analyzers at the same time due to the latter data will overwrite the former one.
Insert a storage device into the USB port if “USB Flash” is selected, and then select “Confirm”.
“Data Export Success” will appear, indicating that the data is transmitted well.
Insert a bluetooth dongle if “Bluetooth” is selected, and then select “Confirm”.
“PCL” will appear, indicating that the data will be transmitted to the host.

Setting the Import Data

Use the down arrows to select “Replace” or “Append”.
NOTE:
Before selecting “Replace”, make sure the inner data is not needed to use or the data has exported for backup.
Insert a storage device into the USB port, and then select “Confirm”.
“Data Import Success” will appear, indicating that the data is transmitted well.
Remove the storage device from the USB port.

Setting the Reset

Select “Reset” in the setting menu.
“Please confirm that you want to reset” will appear, select “Confirm” to reset.

Setting the QC Test Interval

Select “QC Test Interval” in the setting menu.
Select the interval you want to perform: Never, 1 week, 1 month, 3 months or Other.
If Other is selected, you can adjust the desired range from 1 week to 52 weeks.

Setting the Report Headers

Select Line1 or Line2. The Line1/2 screen displays.
Use keyboard to edit
Select Return. (The printer report header information will be saved.)

Setting the Report Headers

Select Line1 or Line2. The Line1/2 screen displays.
Use keyboard to edit.
Press “Save” to confirm the setting, then return to setting mode.

Selecting Training Mode
How to do
Press “Enter” to select training mode.
Animation will be showed repeatedly to help you use the device properly.
Press “Return” to back to main page.
Selecting About Mode

How to do
Press “Enter” to select the mode.
Meter SN, software, and hardware version will be shown on the display.
Press “Return” to back to main page.

MAINTENANCE

Caring for Your Analyzer

Turn the power switch off and disconnect the electrical plug to replace the fan filter.
Turn the power switch off and disconnect the electrical plug to clean the analyzer exterior and accessories, and wipe it with a soft dry cloth. Do NOT rinse with water.

Analyzer Storage

Storage conditions: 10°C to 35°C (50°F to 95°F), 10% to 90% relative humidity.
Always store or transport the analyzer in its original storage case.
Avoid dropping and heavy impact.
Avoid direct sunlight and high humidity.

SYMBOL INFORMATION

Symbol	Referent	Symbol	Referent

| Manufacturer|

| Type B Equipment

| In vitro diagnostic medical device|

| Collection for electrical and electronic equipment

| Consult instructions for use|

| Caution, consult accompanying documents
| Serial number|

| Temperature limitation

| CE mark|

| Model number

| RoHS Compliance|

| Keep away from sunlight

| Storage / transport temperature limitation|

| Storage/transport humidity limitation
| Authorised representative in the European Union|

SPECIFICATIONS

Overview

Model no.	FORA A1C100
System Description	Point-of-care immunoassay analyzer
Quantitative Tests	Hemoglobin A1c (whole blood): Range: 4% to 16%
Test Format	Self-contained immunoassay cartridges
Test Measurement	Automatic, optional transmission
Test Method	HbA1c – monoclonal antibody agglutination reaction
Time to Test Results	HbA1c ≦6 minutes

General
Dimensions| 5.28 (H) x 7.56 (W) x 9.25 (D) inch
13.4 (H) x 19.2 (W) x 23.5 (D) cm
Weight| 3.8 kg (8.38 lbs)
Power Requirements| 100 to 240 VAC; 50/60 Hz
Maximum Power Input| 30 watts
Output| 10 VDC, 3A
Operating Pressure Range| 800 hPa to 1060 hPa
Operating Altitude| Up to 2000 meters (6000 feet)
Operating Temperature| 15°C to 32°C (59°F to 89.6°F) – HbA1c
Storage Temperature| 10°C to 35°C (50°F to 95°F) – HbA1c
Operating Humidity| 10% to 90%, non-condensing, actively controlled
Storage Humidity| 10% to 90%, non-condensing, actively controlled
Test Handling
Sample Volume| HbA1c – ≤ 0.2 μL whole blood
Sample Preparation| No pretreatment; no pipetting required
Patient ID/Operator ID Entry| switch buttons, barcode reader (optional), keyboard (optional)
Computer/ Peripheral Interfaces
AC to 10V DC Power Adapter| DC Power Jack
Memory| 10,000 results
Onboard Printer| Thermal printer, 57 mm (2.28 inch) width x 50mm diameter paper reel
External Output| USB or Bluetooth

TERMS & CONDITIONS OF WARRANTY

We warrant this product to be free of defects in workmanship and materials within the said warranty period on the warranty certificate.
During the warranty period, if this product is found to be defective, you may bring it, together with the purchase receipt and Warranty Certificate, on a carry-in basis to our office during normal business hours for warranty service. We will then repair or replace defective parts or exchange the whole product as we may choose, at no charge to the original owner. After such repair, replacement, or exchange, the product will be warranted for up to the remainder of the warranty period.
This warranty is valid only if the Warranty Certificate and Warranty Registration Card are duly completed with the date of purchase, serial number, and dealer’s stamp, and if the Warranty Registration Card is sent to our office not later than 14 days from the date of purchase.
This warranty is void if this product has been repaired or serviced by an unauthorized person. This warranty does not cover defects caused by misuse, abuse, accident, tampering, lack of reasonable care, fire, or any other acts beyond human control.
Except as stated in the above paragraphs, we disclaim all other warranties, implied or expressed, including the warranties of merchantability or fitness for a particular purpose with respect to the use of this product. We shall not be liable for any direct, consequential or incidental damages arising out of the use or inability to use this product.

Owner’s portion
WARRANTY CERTIFICATE
YEAR WARRANTY

Name of product:……………….
Name of owner:………………
Address:……………
Tel No: (Mobile)…………….. (H) ………….(O)…………..
Email: ………. Age:…………… Gender: □ M □ F

Date of Purchase:

Serial No:…………………..
Dealer’s Stamp:
*NOTE: Please produce this cord together with the purchase receipt la warranty service.
Dealer’s portion
WARRANTY REGISTRATION CARD

Name of product:……………….
Name of owner:………………
Address:……………
Tel No: (Mobile)…………….. (H) ………….(O)…………..
Email: ………. Age:…………… Gender: □ M □ F

Date of Purchase:

Serial No:…………………..

IMPORTANT: To qualify for the warranty, please fill in this cord and mail it to us within 14 days from the dole of purchase.

PLEASE AFFIX STAMP
DEALER’S INFORMATION

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 61326-2-6.

ForaCare Suisse AG
Neugasse 55, CH9000, St. Gallen,
Switzerland
www.foracare.ch
MedNet EC-REP GmbH
Borkstraβe 10, 48163 Mϋnster, Germany
FORA A1C100