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CARDIOAfib+ Description This device is intended for non-invasive measurement of blood pressure in adults in home and professional settings. As a blood pressure-derived measurement, it uses an algorithm to detect heart rate and report the presence of an irregular heartbeat. This device can detect atrial fibrillation (AFIB). 1. Blood pressure measurement This device uses the oscillometric method to measure blood pressure. It allows for rapid and therefore less invasive monitoring, as the measurement occurs while the cuff is inflated. Pic CARDIOAfib+ has been clinically validated according to the international validation protocol (EN ISO 81060-2:2019+A1:2020), guaranteeing its accuracy and precision, even in pregnant women. 2. Detection of atrial fibrillation This device is validated to detect atrial fibrillation in triple measurement mode on patients over 18 years of age, except for pregnant women and women with preeclampsia (accuracy: >99%). If, after taking a triple measurement, the AFIB symbol appears, it indicates the possible presence of atrial fibrillation that occurred during the measurement. The patient is advised to wait a while and take another triple measurement. If the AFIB symbol appears again, the patient is advised to consult a doctor. It is strongly recommended that the patient consult a doctor if the AFIB icon appears frequently. The diagnosis of atrial fibrillation, however, must be made by a cardiologist based on ECG interpretation. The AFIB symbol appears if atrial fibrillation is present in two out of three or all three measurements. 3. Irregular Heartbeat Detector If the monitor detects an irregular heartbeat two or more times during the measurement process, the irregular heartbeat symbol appears on the screen along with the measurement results. An irregular heartbeat is defined as a heartbeat that is at least 25% slower or faster than the average heartbeat detected during systolic and diastolic blood pressure measurements. Consult your doctor if the irregular heartbeat symbol appears frequently in the test results. If the irregular heartbeat appears while the single measurement mode is activated, the patient is advised to wait a while and take a triple measurement to determine if atrial fibrillation has occurred. How to use Installing and replacing batteries 1. Remove the battery compartment cover. 2. Insert the batteries respecting the correct polarity, referring to the symbols inside the compartment. 3. Replace the cover. Pairing with Bluetooth before first use 1. To pair CARDIOAfib+ with your smartphone, access the Pic Health Station app and make sure your smartphones Bluetooth is turned on. Open the menu and select Device - Add Device and follow the apps instructions. 2. With the device off, long press the Memory button: the Bluetooth icon will flash. If pairing is complete, the device will automatically turn off and the pairing will be confirmed in the app. To further confirm the pairing, turn on CARDIOAfib+ by pressing the START-STOP button: the device will now display a solid Bluetooth icon. If pairing fails, CARDIOAfib+ will automatically turn off, but the app will not show pairing as successful. 3. Check that your monitor is connected successfully. 4. The date and time on your device will automatically adjust after the pairing process is complete. 5. You can see your measurements on the app. Setting mode: date/time and measurement interval (without Bluetooth pairing) With the device off, press the User button to enter setup mode. In setting mode, to set the date and time 1. Press the Memory button to change the year. Hold down the Memory button to scroll quickly. Once the desired value is displayed, press the User button to confirm and move to the next selection. 2. Repeat the same steps to set the month, day, 12h/24h format, hour, minute and, if triple measurement mode is selected, the interval between three consecutive measurements (30s, 60s or 90s). Note: The date is in “month-day” format. The user can quickly select the interval between 3 consecutive measurements without entering setup mode. If triple measurement mode is selected: long press the User button to directly select the interval between three consecutive measurements (30s, 60s, or 90s) and select the desired interval using the Memory button. For information on single and triple measurement modes. The device automatically saves settings and turns off after 20 seconds of inactivity or immediately if the START-STOP button is pressed. It is recommended to use the device paired with your smartphone. User change and measurement mode selection With the device off, press the START-STOP button. By default, the last setting used will flash, showing which User (1, 2, or Guest) and measurement mode are selected. Press the User button to change users and use the slider on the right side to toggle between single or triple measurement mode (AFIB mode). If no action is taken for 3 seconds, the current user and measurement mode are confirmed and the measurement will start automatically. How to apply the bracelet 1. Insert the bracelet connector fully into the opening on the left side of the device. 2. Open the bracelet leaving the end in the ring. 3. Insert your arm into the cuff. The tube should be oriented toward your hand. Turn your palm up and position the edge of the cuff approximately 1-2 cm (0.4-0.8) away from the crook of your elbow. Tighten the cuff by pulling on the end. 4. Press the ring and wrap the material tightly. Leave a two-finger gap between the cuff and your arm. Place the artery mark on the main artery (on the inside of the arm). Note: To locate the main artery, press with two fingers about 2 cm above the bend of the elbow on the inside of the left arm. Locate the point where the pulse is most clearly felt. This is the main artery. 5. Lay your arm flat on the table, palm facing up, so that the cuff is level with your heart. Make sure the tube is not kinked. 1) Single measurement Place the cursor on the right side of the device on the single measurement mode and press the START-STOP button. Refer to the Changing Users and Selecting Measurement Modes section to select the desired user. In single measurement mode, the device displays the measurement result. The result is automatically saved if User 1 or User 2 is selected. It is not saved if Guest User is selected. 2) Triple measurement Position the cursor on the right side of the device on the triple measurement mode and press the START-STOP button. Refer to the Changing Users and Selecting Measurement Modes section to select the desired user. Three consecutive measurements will begin, with a predefined interval between measurements. The screen displays the first two measurements and, as a third result, the average of the three (with the AFIB symbol if atrial fibrillation has been detected). The result is automatically saved if User 1 or 2 is selected. NOTE: The device will not start measuring if there is residual air in the cuff from a previous measurement. The icon will flash until the pressure stabilizes. When inflation begins, the air in the cuff slowly increases, and the lower part of the screen displays, indicating that the measurement is in progress. At the same time, the icon appears, indicating that the cuff is tight enough, while the icon indicates that it is not tight enough. If the cuff is not tight enough, you should adjust the fit and repeat the measurement. Warnings - If you do not plan to use the appliance for some time, remove the batteries. - Used batteries are harmful to the environment. Dispose of them according to the instructions in this user manual (Regulation (EU) 2023/1542). - Do not throw batteries into fire. They may explode or leak. - For battery disposal instructions, see the instructions at the end of this manual. - There are no user-serviceable parts inside. Batteries or damage caused by used batteries are not covered under warranty. - Use only brand-name batteries. Always replace all batteries. Use batteries of the same brand and type. Other types of batteries may cause explosions or fires. - The battery may explode if handled carelessly. Do not recharge, remove, or place batteries near a heat source. Do not incinerate. - The device can be powered by rechargeable batteries. - Rechargeable batteries cannot be charged inside the device. - Do not measure your blood pressure immediately after bathing: wait at least 20 minutes. - Do not take measurements when you are tired or physically exhausted. - Do not measure your blood pressure when you feel the urge to urinate. - It is important to be relaxed during the measurement. - Do not take measurements under stress or tension. - Measure your blood pressure at normal body temperature. If you feel hot or cold, wait a while before taking the measurement. - Relax for 5 minutes before measuring. - Take 3 measurements within 3 minutes. Do not exceed three consecutive measurements to avoid adverse effects on normal blood circulation. - Perform the measurement in a quiet room. - Do not move or talk during the measurement. - Do not cross your legs and keep your feet on the ground. - Keep your back supported against the back of the chair. - To ensure a meaningful comparison, try to take measurements under similar conditions. For example, take daily measurements at approximately the same time, on the same arm, or as directed by your doctor. Code 5802253602000
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