QOCA bioreader (Non-sterile) QOCA bioreader (Non-sterile) User manual Model: QOCA bioreader For in vitro diagnosis only Before use, please read this user manual carefully and follow all instructions given. MHC418-3A
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Intended Use This device is an in vitro diagnostic device performing quantitative analysis on enzymes in human blood by using a proper enzymatic chip detection kits, and suitable for the use in hospitals and medical laboratories by doctors or medical laboratory scientists. Description This device, utilizing EIS (electrochemical impedance spectroscopy), measures the data through a proper enzymatic chip detection kit and displays the results on the screen. QOCA bioreader is easy to use. Simply drip the specimen on the reactive area of chip and then connect to QOCA bioreader. The device will display the quantitative results in 3-5 minutes. This device, with built-in various enzyme concentration algorithms and corresponding detection chip kits, allows the user to measure the concentration of different enzymes. QOCA bioreader is for in-room use only and not suitable for self-test. Environmental pollution level: 2
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Cautions Taking out the detection chip during test may damage QOCA bioreader. To prevent specimen, device and environmental contamination, please clean QOCA bioreader regularly. Please clean immediately when specimen splashes or after moving the specimen to QOCA bioreader. For details, please refer to the Clean section in this manual. Put QOCA bioreader on a stable surface to prevent dropping. Avoid other objects from falling on QOCA bioreader. QOCA bioreader may not be able to turn on successfully due to misuse (like dropping), out of battery or other factors.In a clinical environment requiring fail-safe, it is necessary to prepare backup batteries to minimize such risk. QOCA bioreader should only be used in an environment within the operating temperature or humidity range. When operating in an extreme environment, please balance QOCA bioreader under the operating conditions for a certain period of time before use. QOCA bioreader is not suitable for use in a hyperbaric oxygen environment. QOCA bioreader may be contaminated by blood from previous tests. Please take general protective measures when using QOCA bioreader to prevent attacks of bloodborne pathogens. General protective measures refer to the standard processes and actions, including wearing gloves and medical masks, to protect the user against attacks of bloodborne and human pathogens. The aforementioned measures are based on the following consumptions: blood, bodily fluid or tissue may contain infectious substances and should be handled as a biological hazard. Please use the correct chip kit and corresponding algorithm to ensure a correct result. Please read the user manual of chip kit carefully before testing. Do not modify the device or change software/hardware settings without a written permission of Manufacturer.
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Description of system QOCA bioreader system provides a kit necessary for enzymatic analysis. By using a QOCA bioreader, an enzymatic chip detection kit proper for the test item, a single-
use specimen transfer dongle and USB-C/USB-C specimen transfer cable, medical staff can check the quantitative data displayed on the screen within 5 minutes. Parts identification Accessories 1. Single-use specimen transfer dongle 2.USB-C/USB-C cable 3.USB-A/USB-C power cable Other accessories:
1. Certified proper enzymatic chip detection kit Options:
1. 9V Alkaline battery 2. Single-use transfer dongle (20 pcs/pack) 3. AC/DC Adapter : SHENZHEN FUJIA APPLIANCE CO., LTD, model: FJ-SW328U0502000N
*Options are sold separately by Manufacturer
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Description of device
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Using the device First use and update specimen lot information. Step 1 When you turn on the QOCA bioreader for the first time, you will see a prompt screen to update the lot number information of the speciment.
* This screen only appears when using the QOCA bioreader for the first time. Step 2 Use USB-A/USB-C power cable connect the QOCA bioreader and the computer. Open the AP of MHC Tool for lot number update. Step 3 Scan the lot number on the package with 2D barcode scanner. Step 4 The QOCA bioreader will be ready for measurement after completing self-
inspection.
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Step 5 Press the left button to enter the information screen and check the packaging batch number. Step 6 When using test chips with different lot numbers, please repeat STEP 2 ~ STEP 4 to update the chip lot number information to ensure that the measurement information is complete. Operation Process Step 1 Connect USB-A/USB-C power cable to the charger port on top of QOCA bioreader. QOCA bioreader will be ready for measurement after completing self-
inspection.
* When powered by a 9V Alkaline battery, please turn on QOCA bioreader by pressing the power button on top. QOCA bioreader will be ready for measurement after completing self-inspection. Step 2 Connect USB-C/USB-C cable to QOCA bioreader and single-use specimen transfer dongle.
*When using, please make sure that the words QOCA on the transfer dongle stand face up.
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Step 3 Follow the user manual of test chip and drip the specimen on the specified area. After the reaction is completed, connect the test chip to a single-use transfer dongle. Step 4 Press Middle-button to start Measurement. Step 5 The result will be displayed on the screen, including values and units. Step 6 After the test, please remove the chip and transfer dongle, put them in a zipper bag and dispose as biological waste. Step 7 After the test, the screen of QOCA bioreader will dim after idling for 1 minute and enter sleep mode. Press any button to wake the device. If QOCA bioreader will not be used for a long time, please disconnect USB-A/USB-C power cable.
* When powered by a 9V Alkaline battery, please turn off QOCA bioreader by pressing the power button on top.
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Reset process Step 1 To delete data, press Right-button to enter RESET screen. Step 2 Gently press the power-button and RESET will be displayed on the screen. Long-
press the power-button for 3 seconds and release if you are sure to delete the data. If not, press Left- or Right-button to exit Delete process. Step 3 Deleting data. Step 4 After the data is cleared, it will return to the initial settings. At this time, you need to log in the chip lot number again to continue use.
*please reference First use and update specimen lot information
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BLE Connection Step 1 When QOCA bioreader is turn on and ready . Step 2 1)Turn on the BLE connection AP(Bioreader) of the mobile phone. 2)Enter the QOCA bioreader serial number at the position of (1) . 3)Press the CONNECTs button at the position (2). Step 3 1)When the connection is successful ,the BLE symbol will appear on the QOCA bioreader. 2)The status of the BLE connection AP will display Connected. 3)QOCA bioreader can start measuring now. Step 4 1)When the QOCA bioreader measurement is completed, Press the Get_Data button at the position (3). 2)BLE connection AP will get test results from QOCA bioreader.
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Specifications Dimensions Weight Operating temperature Operating humidity Transportation/storage temperature Transportation/storage humidity IP rating L 13.6 * W 8.3 * H 3.4 (cm) 195 5g (battery excluded) 5 ~ 40C 10 ~ 80% RH
-5 ~ 50C 10 ~ 85% RH IP 22 Power supply DC 5V / 500mA or 9V Alkaline battery Altitude Under 2,000m (813 ~ 1013 hPa) Technologies Electrochemical impedance spectroscopy (E.I.S) Product service life 3 years Replacement Battery Flip over QOCA bioreader (the display facing the table) Use a flathead screwdriver or coin to remove screws of battery cover. Take out the old battery from the chamber and replace with a 9V Alkaline battery. Place the battery into the chamber. Put back the cover and secure with screws. Clean After use, spray 75% alcohol or 5% bleach on a lint-free cloth and clean the enclosure gently. Electromagnetic Interference QOCA bioreader is compliant with the radiation interference and anti-interference requirements in IEC 61326-2-6. Please do not use the device near a strong magnetic field to ensure normal operations.
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Disposal of the system Please observe the local rules and regulations when disposing of the system or its components. Maintenance Please store and use the device within the specified temperature and humidity range. Keep QOCA bioreader out of direct sunlight or extreme environments. Troubleshooting Unexpected result When the results cannot accurately reflect the patients condition, please retest with a new chip detection kit and specimen. If the result is still suspicious, please refer to Manufacturer section. Problem The device won't turn on Cause Action The device is out of battery, rechargeable battery is completely discharged or the switch is broken. Replace primary battery or charge rechargeable battery before use. If the device still wont turn on, please contact your sales representative. No display The device is out of battery or rechargeable battery is completely discharged. The device is out of battery or rechargeable battery is completely discharged. USB-C connector is worn out Low battery Failure of continuous testing Cannot measure Replace primary battery or charge rechargeable battery before use. Power by connecting to USB-C port on top of the device. If the issue persists, please contact your sales representative. Replace primary battery or charge rechargeable battery before use. Replace with the same type of USB-C cable from Manufacturer. Damaged buttons Please contact your sales representative. Incorrect date/time Real-time clock (RTC) out of battery Please contact your sales representative.
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Repair Do not try to repair by yourself. Please contact your sales representative for repair. Symbols Symbol Description Please read this manual carefully before use Manufacturer name and address Manufacture date Storage temperature range Lot No. Serial No. In vitro diagnostic device Model Do not use repeatedly Warning IP rating Humidity limitation
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IP Disclaimer Please use the original accessories and follow the specifications and regulations provided by the manufacturer. The Company is not liable for any direct or indirect damage resulting from the misuse of device. FCC Statement 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.
Federal Communications Commission (FCC) Statement 15.105(b) 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.
15.21 You are cautioned that changes or modifications not expressly approved by the part responsible for compliance could void the users authority to operate the equipment.
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FCC RF Radiation Exposure Statement:
1. This Transmitter must not be co-located or operating in conjunction with any other antenna or transmitter. 2. This equipment complies with FCC RF radiation exposure limits set forth for an uncontrolled environment. For portable operation, this device has been tested and meets FCC RF exposure guidelines. When used with an accessory that contains metal may not ensure compliance with FCC RF exposure guidelines. Manufacturer For further assistance, please feel free to contact the Quanta Customer Service Medical device supplier: Quanta Computer Inc. Hwa Ya Medical Devices Fab 2 Address: 1F, No. 188, Wenhua 2nd Rd., Guishan Dist., Taoyuan City, Taiwan Telephone: +886-3-3272345 Manufacturer: Quanta Computer Inc. Hwa Ya Medical Devices Fab 2 Address: 1F, No. 188, Wenhua 2nd Rd., Guishan Dist., Taoyuan City, Taiwan Telephone: +886-3-3272345
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