Summary of Contents for DarioHealth LS802-GP
- Page 1 Dario Smart Monitor (Cellular) Blood Pressure Monitoring System User Manual Model: LS802-GP (P/N - 1168-05) 710-0378020020 Ver 1.0...
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Page 2: Table Of Contents
Table of Contents Indications for use ........................3 Disclaimer ...........................3,4 Supported devices and operating systems ................4 Help and warranty ........................4 What’s in the box .................4 Blood pressure monitor description ........5 Display ............................6 Before you measure - important information ..............7 Getting started ................8 Downloading the dario app ....................8 Setting up your dario smart monitor ........ -
Page 3: Indications For Use
Thank you for choosing the Dario Smart Monitor The Dario Smart Monitor allows you to monitor your blood pressure from the comfort of your home or of- fice. Track your trends to get a better overview of your condition. Store all your readings in the Dario App and get alerts you can easily share with your doctor regarding potential health complications. -
Page 4: Supported Devices And Operating Systems
If you are taking medication, consult your healthcare pro- fessional to determine the most appropriate time to mea- sure your blood pressure. Do NOT change a prescribed medication without consulting your healthcare provider. Supported devices and operating systems The Dario Smart Monitor works with Android 8 & above and with iOS 12 &... -
Page 5: Blood Pressure Monitor Description
Blood pressure monitor description CUFF TUBE CONNECTOR AC POWER SOCKET START/STOP BUTTON CUFF TUBE CUFF BATTERY DOOR BATTERY COMPARTMENT... -
Page 6: Display
Display SYMBOL DESCRIPTION Systolic blood pressure Diastolic blood pressure Pulse per minute Current time Heartbeat detected during measurement Blood pressure measurement unit Current battery status Irregular heartbeat Data transmission indication: Blinks to indicate data is being sent Disappears after successful transmission Movement detected during measurement No signal... -
Page 7: Before You Measure: Important Information
Before you measure: Important information The device shouldn’t be used on: Infants Pregnant women Anyone with electronic implants, pre-eclampsia, premature ventricular beats, atrial fibrillation, or peripheral arterial disease Anyone undergoing intravascular therapy or who has an arterio-venous shunt Anyone who had a mastectomy Anyone allergic to polyester, nylon, or plastic Note: Contact your health care provider for information about using this device if you suffer from... -
Page 8: Getting Started
Downloading the Dario App 1. Go to the App Store or Google Play and search for DarioHealth. Download the Dario App. For quicker access you can scan the QR code. 2. Open the Dario App. 3. If you have an existing account, log in. -
Page 9: Setting Up Your Dario Smart Monitor
Setting up your Dario Smart Monitor Installing and replacing the batteries 1. If this is your first time using the device: Open the battery compartment cover located on the back of the monitor. Insert 4 AA batteries into the battery compart¬ment and close the cover. 2. -
Page 10: Setting Up A Cellular Connection
Setting up a cellular connection After you insert the batteries, you will see the symbol on the LCD, indicating that your monitor is automatically connecting to the cellular network. If the connection is successful, will be displayed. The monitor will turn off automatically. If the connection fails, the monitor will turn off automatically after several minutes. - Page 11 Still can’t connect Contact Dario Customer Support Monday to Friday 9:00 AM – 9:00 PM EST 1-800-895-5921 https:/ /mydario.com/support/getting-started/ Note: To see the correct time and date for your measurements in your app logbook, the Dario Smart Monitor must be connected to the cellular network.
- Page 12 Pair your Dario Smart Monitor and the Dario App 1. On the Dario App, go to Menu. 2. Select SETTINGS. 3. Open the CONNECTED APPS & DEVICES screen. 4. Select Dario Smart Monitor (Cellular). 5. Follow the app instructions for pairing your monitor with the app.
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Page 13: First Time Measurement
First-time measurement Get ready Do not measure within 30 minutes of eating, drinking, smoking, exercise, or bathing. If possible, relax and rest for at least 5 minutes before taking a measurement. Avoid taking measurements when stressed. Avoid taking measurements in a noisy or cold environment. -
Page 14: Prepare Your Monitor
Prepare your monitor Do not use the monitor if it is damaged. Using a damaged unit can cause serious injury and can result in incorrect measurements. Wireless communications equipment such as wire- less home network devices, mobile phones, cordless telephones and their base stations, and walkie-talkies, can affect the monitor and should be kept at least 40 inches (1 meter) away from it. -
Page 15: How To Measure
How to measure 1. Plug the connector on the cuff tube into the monitor. CUFF TUBE CONNECTOR AC POWER SOCKET START/STOP BUTTON CUFF TUBE CUFF 2. Open the cuff and orient the cuff so that the tube exits towards the hand. 3. - Page 16 5. Tighten the cuff evenly around your arm by pulling on the end. Make sure the Ф marker stays aligned with the center of your arm. 6. Wrap the end of the cuff over your arm to secure it in place.
- Page 17 8. When the monitor is off, press the “START/STOP” button to turn it on. 9. The screens below will appear as you measure: 1. LCD display 2. Start screen 3. Measurement screen 4. Results screen...
- Page 18 After you measure, the monitor will transmit your data. The blinking symbol “ ” on the LCD indicates that data is being transmitted. Please note: If you experience discomfort during measurements, such as pain in your arm or anything else, press the “START/STOP” button to release the air immediately from the cuff.
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Page 19: Troubleshooting
Troubleshooting Having a problem with your Smart Monitor? Check the list below for common issues and what to do about them. ISSUE SOLUTION Check that the batteries/AC were inserted Display correctly. If the batteries were inserted correctly will not light up and you still see this message, you may need to replace them. -
Page 20: Care & Maintenance
Care & maintenance The service life of the cuff can be affected by the fre- quency of washing, skin condition, and storage state. The typical service life is 10,000 measurements. Do not subject the monitor to shaking or strong shocks, such as dropping on the floor. Avoid dust and extreme hot or cold temperatures. -
Page 21: Faq: All About Blood Pressure
FAQ: All about blood pressure What are systolic pressure and diastolic pressure? Blood pressure is written as two numbers. The top (sys- tolic) number is the pressure when the heart beats. The bottom (diastolic) number is the pressure when the heart rests between beats. - Page 22 Why does my blood pressure fluctuate throughout the day? Individual blood pressure varies throughout the day. This can be due to weather, emotion, exercise, and more. It is also affected by the way you tighten your cuff and your mea¬surement position, so please take measurements under the same conditions whenever possible.
- Page 23 What is the Irregular Heartbeat Detector? An irregular heartbeat (IHB) is detected when a heartbeat rhythm varies while the device is measuring systolic pres- sure and diastolic pressure. During each measurement, the Dario Smart Monitor will keep a record of all the pulse intervals and calculate the average value of them.
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Page 24: Device Specification
Device Specification Battery powered mode: 6V DC 4x AA batteries AC Adaptor powered mode: 6V 1A (not included) Power supply (Please only use the recommended AC Adaptor). Display mode Digital LCD V.A. 3.1in*3.6in (78mm*92mm) Measurement mode Oscillographic testing mode Rated cuff pressure: 0 mmHg ~ 299 mmHg (0 kPa ~ 39.9 kPa) Measurement pressure: Measurement range... -
Page 25: Safety
SAFETY Safety Information The signs below might be in the user manual, labeling or other components. They are standard usage requirements “THE OPERATION “TYPE BF APPLIED GUIDE MUST BE READ” PARTS” “ENVIRONMENT PROTECTION - “MANUFACTURER” Electrical waste products should not be disposed of with household waste. -
Page 26: Fcc Statement
(2) this device must accept any interference received, including interference that may cause undesired operation. Caution! Changes or modifications not expressly approved by DarioHealth shall cancel the warranty and any liability DarioHealth might have in connection with this device. -
Page 27: Emc Guidance
Warning: Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of the equipment LS802-GP, including cables specified by the manufacturer. Otherwise, degradation of the perfor- mance of this equipment could result. - Page 28 Table 2 Guidance and manufacturer’s declaration – electromagnetic Immunity IEC 60601-1-2 Immunity Test Compliance level Test level Electrostatic ±8 kV contact ±8 kV contact discharge (ESD) ±2 kV, ±4 kV, ±8 kV, ±15 kV air ±2 kV, ±4 kV, ±8 kV, ±15 kV air IEC 61000-4-2 Electrical fast Not applicable...
- Page 29 Table 3 Guidance and manufacturer’s declaration - electromagnetic Immunity IMMUNITY Radiated RF Test Band Service Modulation Modulation Distance TEST Frequency (MHz) IEC61000-4-3 LEVEL (MHz) (Test (V/m) specifications 380-390 Pulse TETRA modulation b) ENCLOSURE 18 Hz PORT IMMUNITY to 430-470 GMRS 460, FM c) ±5 kHz RF wireless deviation...
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Page 30: Standards Compliance List
Standards Compliance List EN ISO 14971:2012 / ISO 14971:2007 Medical devices - Application Risk management of risk management to medical devices EN ISO 15223-1:2016 / ISO 15223-1:2016 Medical devices. Labeling Symbols to be used with medical device labels, labelling and information to be supplied. - Page 31 Monday to Friday 9:00 AM – 9:00 PM EST 1-800-895-5921 https://mydario.com/support/getting-started Distributed by DarioHealth Corp 142 W. 57th Street, 8th Floor New York, NY 10019 Toll Free:1-800-895-5921 (Mon to Fri / 9am to 9pm EST) For assistance outside of these hours,...