DİAGNOVİR COVID 19RAPID DIAGNOSTIC SYSTEMDiagnovir test system is an in-vitro diagnostic medical device.

Product Name: Diagnovir COVID-19 Antigen Rapid Diagnosis Kit (With Device)

Device : Diagnovir Analyzer

Test System Content:

Analysis Kit (Test Chip)

Transfer Kit = Transfer Tube + Swab Stick (Solution Tube) (Swabs)

Number of Analysis Kits : 30 Pcs/Package

Sampling : Oral cavity, cheek swab

Test Period : 10-30 sec

Analysis Kit Shelf Life : 1 year under proper storage conditions

Storage Conditions:

For Analyzer

Storage conditions : 10-95% relative humidity, temperature 10-500C

Working conditions : 30-85% relative humidity, temperature 10-400C

For Analysis Kit

Storage Conditions :10-95% relative humidity, temperature 2-80C

Operating Conditions : 30-85% relative humidity, temperature 10-400C

For Transfer Kit

Storage Conditions : 10-95% relative humidity, temperature 4-300C

Operating Conditions : 30-85% relative humidity, temperature 10-400C

Diagnovir Antigen Rapid Diagnostic Test is in vitro diagnostic medical device. It is a specific diagnostic system produced specific to COVID-19 (SARS-COV-2), which is easy to use and gives

rapid results.

Diagnovir test device (analyzer) consists of transfer kit (transfer tube, swab) and analysis kit.

• The device can only be used for in vitro Covid-19 (SARSCOV-2) diagnostic purposes with Diagnovir Analysis Kit and Transfer Kits

• The test should be used in accordance with the instructions of the user manual

• The test can be performed by a trained health professional

• Eating or drinking is forbidden within 15 minutes before the test

The product is designed to detect Covid-19 (SARS-COV-2) virus with a saliva sample taken from the oral cavity via Diagnovir Antigen Rapid Diagnostic Test.

PRODUCT CONTENT

System Analyzer becomes operational with the power button on the device after the mains electricity connection is made. After the device is turned on, after “Test” warning on the screen,

Diagnovir Analysis Kit that has reached room temperature will be put in and ready to measure.

Diagnovir Analysis Kit should be kept outside in its protected box for approximately 20 minutes until it reaches room temperature. After Diagnovir Analyzer is operational, process is started in accordance with the instructions shown on the LED display. Firstly, “Test” warning appears on LED display on Diagnovir Analyzer upon completion of “Preparing System” phase. When the cover is closed, the test is started by pressing “Test” button. Secondly, Diagnovir Analysis kit is placed in the incubation slot and the cover is closed when the message “Insert Kit” appears on LED display. “Place Kit” button is pressed and waited until “Put Sample” warning appears. The sample prepared in the Transfer Tube (see Sample collection section) is added to the hole on the

kit by opening the covers of the incubation slot and the analysis chip with the transfer tube, the covers of the analysis kit and the incubation slot are closed. Finally, the test starts when “Put Sample” button that appears on the screen is pressed. “Test in Progress” warning will appear on LED display and after the analysis is completed, the test result will appear on the display. The resulting Diagnovir Test kit should be disposed as medical waste by opening the cover of the incubation slot. As soon as “Test” button is pressed, the system will be ready for testing with a new Diagnovir Analysis kit. The next analysis can be performed by repeating the same test procedures.

SYSTEM OPERATION

TEST PROCEDURE

PRODUCT DESCRIPTION

USAGE RESTRICTIONS

INTENDED USE OF THE PRODUCT

The swab stick included in the transfer kit should be collected from the oral cavity of the person to be diagnosed, or when necessary (for example, in people whose oral cavity cannot be sampled) by entering 1-2 cm from the nasal cavity. The swab is placed in the transfer tube without touching anywhere. It is

removed from the tube turning right and left for a few seconds, the used swab is thrown into the medical waste box and the cover of the transfer tube is closed. 1 drop of sample from the solution in the transfer tube is added to Diagnovir Analysis Kit. (One drop of the transfer tube is set to drop 20µL of sample)

• Consumables, spare parts and other auxiliary devices recommended by Felisya Biomedical should be used.

• The device should never be used as follows;

1. When non-recommended modifications are made to the device,

2. Where the device is no longer safe due to wear or damage,

• This equipment may only be connected to a feed network with protective earthing to avoid the risk of electric shock.

• The laser used inside the device (according to IEC 60825-1) is a closed hazard, it should not be opened by unauthorized persons.

• Protective clothing should be used during the test (glasses, bonnet, gloves, apron, etc.)

• Unauthorized persons should not use the device

• In cases where possible contamination is thought;

1. The contamination area should be disinfected.

2. The infected person should be monitored during the window stage of the disease.

• The lens at the bottom of the measuring chamber of the device should never be touched by hand, with a wipe that leaves particles and oil.

• Working materials and consumables should be used safely, suspicious consumables should not be used. All used consumables should be disposed as medical waste after use.

• The device should be disposed within the scope of WEEE (Waste Electrical and Electronic Equipment).

• Incubation Slot contains Class 3B laser. In case of looking

straight with the naked eye, the nearest health institution should be consulted.

• Diagnovir Test Device should only be used by the persons previously trained by the manufacturer.

• Diagnovir Test Device should be stored not to be exposed to any damage.

• The gloves used in the sampling process should be thrown into the medical waste box at the end of the process.

• Swab Stick should be placed in the transfer tube after sample collection and thrown into medical waste after the specified procedures are done.

• Transfer Tube should be disposed as medical waste after the sample is transferred to Diagnovir Test Kit.

• Diagnovir Test kit should be stored at a temperature range of 2 - 8°C and in a dark environment.

• No solid or liquid material should be added to the solution in the test kit, other than the sample to be taken from the person to be tested.

• If any cracks, fractures and/or fluid leaks are seen on the kit, it should be thrown into medical waste in accordance with the instructions.

• The contents in the kit are completely disposable and should be thrown into medical waste at the end of the sampling process.

• Sampling should only be done with the kit contents provided by the manufacturer.

• Only instructions shown on LED display of Diagnovir Test Device and described in the user manual should be followed.

COLLECTION AND TRANSPORT OF SAMPLES

CONSIDERATIONS

Run the device. Dip the sample into the solution, mix.

Drop the solution into the test kit.

Take a sample from the person’s mouth with a swab stick.

Insert the test kit into the device.

Wait 10-30 seconds for the result.

ADIM 01 ADIM 03

ADIM 05

ADIM 02

ADIM 04 ADIM 06

KULLANIM TALİMATLARI

A SUBSIDIARY OF BİLKENT HOLDINGÜniversiteler Mah. 1607. Cad. No: 3/106800 Bilkent, Ankara/TÜRKİYE

info@felisyabiyomedikal.comwww.felisyabiyomedikal.com

+90 312 266 06 60

• Make the electrical connection of the device and run it

• Wait until “Preparing System” display turns to “Test” display

• Press “Test” display

• When “Place Kit” display appears, place the analysis kit and press “Place Kit” display

• When “Put Sample” display appears, open the chip cover and drop a sample

• Close the chip cover, close the device cover, press “Put Sample” display

• Wait during “Test in Progress” display

• Test result is ready “Covid Negative” “Covid Positive”

TEST DEVICE STAGES

• Make sure that the person to be tested has not eaten or drank anything until 15 minutes before the test

• Take a swab from both cheeks through the oral cavity with a swab

• Open the transfer tube cover and dip the sampled swab into the solution

• Turn the swab right and left, wait a few seconds

• Remove the swab stick and throw it into medical waste

• Drop 1 drop from sample into test kit

SAMPLING STAGES