DARIO 1168-05 Smart Monitor Blood Pressure Monitoring System User Manual

DARIO 1168-05 Smart Monitor Blood Pressure Monitoring System

Model: 1168-05

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 office. 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.

Indications for Use

The Dario blood pressure monitoring system is intended for measuring blood pressure and heart rate in adults with an arm circumference ranging from 8¾- 16½ (22 cm to 42 cm). It is intended for adult indoor use only.

Disclaimers

This device is intended for non-invasive measuring and monitoring of arterial blood pressure. It is not intended for use on extremities other than the arm or for functions other than obtaining a blood pressure measurement. This device does NOT serve as a cure for any symptom or disease. The data measured is for reference only. Always consult your healthcare provider to have the results interpreted.
If you are taking medication, consult your healthcare professional to determine the most appropriate time to measure 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 & above. You can find the most updated list of supported system here: https://mydario.com/support/getting-started/

Help and Warranty

For help follow the link below: www.mydario.com/support/getting- started
For Warranty information follow the link below: https://mydario.com/return- policy/

What’s in the box

1. Blood pressure monitor
2. Pressure cuff
3. Owner’s manual
4. Batteries

Blood pressure monitor description

Display

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 healthcare provider for information about using this device if you suffer from any other illness.

GETTING STARTED

The Dario Smart Monitor automatically uploads your data to your Dario App via a cellular network. Make sure that you have the latest version of the Dario App installed on your smartphone.

Downloading the Dario App

1. Go to the App Store or Google Play and search for DarioHealth. Download the Dario App.
2. For quicker access you can scan the QR code.
3. Open the Dario App.
4. If you have an existing account, log in.
5. If not, tap Sign Up and follow the instructions.

Setting up your Dario Smart Monitor

Installing and replacing the batteries

• 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 compartment and close the cover.
• Replace the batteries whenever the following happens:
  • is displayed
  • The display dims
  • The display does not light up

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. To stop connecting, press and hold the “START/ STOP” button at any time, until the device is turned off.

One possible reason for connection failure is an unstable cellular network. Try again in another location with a stronger signal. You can check the cellular network strength on your smartphone.

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. This happens automatically the first time you turn it on or when you replace the batteries.

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.

Congratulations! You’re ready to start measuring.

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.
• Remove tight-fitting clothing from your upper arm.
• Sit on a chair with your feet flat on the floor.
• Rest your arm on a table so that the cuff is at the same level as your heart.
• Remain still and do not move your fingers or talk during measurement.

Note : A single measurement may not provide an accurate indication of your true blood pressure. Try to measure your blood pressure at the same time each day for consistency.

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 wireless 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.

Warnings

• Do not twist the connection tube during use.
• This can cause the cuff pressure to inflate continuously, which can prevent blood flow and result in serious injury.
• Do not apply the cuff over a wound as it may cause injury.
• Do not inflate the cuff on an arm that is already using another medical electrical monitoring device, as this could cause the monitoring equipment to stop working temporarily.
• Keep the monitor out of the reach of infants, young children, and pets, to avoid inhalation or swallowing of small parts.

How to measure

1. Plug the connector on the cuff tube into the monitor.
2. Open the cuff and orient the cuff so that the tube exits towards the hand.
3. Place your arm through the cuff loop, with your palm facing up. Position the cuff’s edge about an inch (2­3 cm) above the elbow.
4. Align the marker (located to the right of the tube exit) with the center of your arm.
5. Tighten the cuff evenly around your arm by pulling on the end. Make sure the marker stays aligned with the center of your arm.
6. Wrap the end of the cuff over your arm to secure it in place. Do not make it too tight ­ leave room for a finger to fit between the cuff and your arm.
7. Place your arm on a table with your palm facing up. The cuff should be at the same height as your heart. Sit up straight and rest your feet flat on the ground.
8. When the monitor is off, press the “START/STOP” button to turn it on.
9. The screens below will appear as you measure:
10. LCD display
11. Start screen
12. Measurement screen
13. Results screen
14. 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. Loosen the cuff and remove it from your arm.

Troubleshooting

Display

will not light up

or

shows on screen

|

Check that the batteries/AC were inserted correctly. If the batteries were inserted correctly and you still see this message, you may need to replace them.

E1: The cuff is not secure or inflation is abnormal| Refasten the cuff and measure again.
E2: Movement detected during measurement| Relax for a moment and then measure again.
E3: No pulse

detected

| Loosen the clothing on your arm and measure again.
E4: Measurement failed| Relax for a moment and measure again.
E5: Server communication failure| Contact customer service.
E6: Radio communication failure| Contact customer service.
EExx: Calibration error| Retake the measurement. If the problem persists, contact the retailer or our customer service department for further assistance. Refer to

the warranty for contact information and return instructions.

Warning message: Out of range measurement| Relax for a moment. Refasten the cuff and then measure again. If the problem persists, contact your healthcare provider.

Having a problem with your Smart Monitor? Check the list below for common issues and what to do about them.

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.
• Storage temperature: -4°F to +140°F (-20°C to +60°C).
• Do not use wet cloths to remove dirt and do not wash the cuff.
• When not in use, store the device in a dry room and protect it against extreme moisture, heat, lint, dust, and direct sunlight.
• Note : The typical service life is 10000 times.
• If you have any problems setting up or using your Smart Monitor, please contact the Dario Customer Service Department.

FAQ

All about blood pressure

What are systolic pressure and diastolic pressure?

Blood pressure is written as two numbers. The top (systolic) number is the pressure when the heart beats. The bottom (diastolic) number is the pressure when the heart rests between beats.

What is the standard blood pressure classification?

The chart below is the standard blood pressure classification published by American Heart Association (AHA).

140 or higher

|

or

|

90 or higher

Hypertensive Crisis (Consult your doctor immediately)| Higher than 180| and/or| Higher than 120

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 measurement position, so please take measurements under the same conditions whenever possible. Certain medications can also affect your measurements.

Why do I get different blood pressure readings at home compared to the hospital?

A phenomenon known as “white coat syndrome” may cause blood pressure to increase in clinical settings.

Is the result the same if I measure on different arms?

The monitor works for both arms, but there may be different results for different people. We suggest you measure on the same arm every time.

What is the Irregular Heartbeat Detector?

An irregular heartbeat (HB) 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. If there are two or more pulse intervals and the difference between each interval and the average is more than the average value of 25%, or there are four or more pulse intervals and the difference between each interval and the average is more than the average value of t15%, then the irregular heartbeat symbol will appear on the display with the measurement result.
The appearance of the IHB icon indicates that a pulse irregularity consistent with an irregular heartbeat was de- tected during measurement. If the symbol appears often, we recommend you seek medical advice. Please note that the device does not replace a cardiac examination but serves to detect pulse irregularities at an early stage.

Measurement Principle

This product uses the Oscillometric Measuring method ete unit establishes a “zero pressure” equivalent to the at mospheric pressure. Then it starts inflating the arm cuff meanwhile, the unit detects pressure oscillations genre ated by beat-to-beat pulsatile, which is used to determine the systolic and diastolic pressure, and also pulse rate.

Device Specification

WARNING: No modification of this equipment is allowed.

SAFETY

Safety Information

The signs below might be in the user manual, labeling or other components. They are standard usage requirements

FCC Statement contains

FCC ID: XMR201910BG95M3

This device complies with Part 15 of the FCC Rules. Operation is subject to 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. Caution! Changes or modifications not expressly approved by DarioHealth shall cancel the warranty and any liability DarioHealth might have in connection with this device. NOTE: 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.

FCC Radiation Exposure Statement:

This equipment complies with FCC radiation exposure limits set forth for an uncontrolled environment. This transmitter must not be co-located or operating in conjunction with any other antenna or transmitter.

EMC Guidance

The ME EQUIPMENTor ME SYSTEM is suitable for home healthcare environments. Warning: Do not use near active HF surgical equipment and the RF shielded room of an ME system for magnetic resonance imaging, where the intensity of EM disturbances is high. Warning: Use of this equipment adjacent to or stacked with other equipment should be avoided because it could resut in improper operation. If such use is necessary, this equipment and the other equipment should be observed to verify that they are operating normally. Warning: Use of accessories, transducers and cables other than those specified or provided by the manufacturer of this equipment could result in increased electromagnetic emissions or decreased electromagnetic immunity of this equipment and result in improper operation. 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 equipment 1168-05, including cables specified by the manufacturer. Otherwise, degradation of the perform mance of this equipment could result

Technical description

1. All necessary instructions for maintaining BASIC SAFETY and ESSENTIAL PERFORMANCE with regard to electromagnetic disturbances for the expected servicelife.
2. Guidance and manufacturer’s declaration – electromagnetic emissions and Immunity

Table 1

Guidance and manufacturer’s declaration – electromagnetic emissions

Emissions test| Compliance
RF emissions CISPR 11| ****

Group 1

RF emissions CISPR 11| ****

Class [ B ]

Harmonic emissions IEC 61000-3-2| ****

Class A

Voltage fluctuations / flicker emissions

IEC 61000-3-3

| ****

Comply

Table 2

Guidance and manufacturer’s declaration – electromagnetic Immunity

Immunity Test| IEC 60601-1-2

Test level

| Compliance level
Electrostatic discharge (ESD) IEC 61000-4-2| ±8 kV contact

±2 kV, ±4 kV, ±8 kV, ±15 kV air

| ±8 kV contact

±2 kV, ±4 kV, ±8 kV, ±15 kV air

Electrical fast transient/burst IEC 61000-4-4| ±1 kV ±2 kV,100 kHz repetition frequency| For AC power port: Power supply lines: ±2 kV
Surge IEC61000-4-5| ±1 kV (Line to ±0.5 kV line)

±0.5 kV ±1 kV ±2 kV (Line to ground)

±2 kV Signal line (LAN line)

| For AC power port: Line to lines: ±1 kV
Voltage dips, short interruptions and voltage variations on power supply input lines

IEC 61000-4-11

| 0%, 70%, 0% of UT| For AC power port:

0% for 0,5 cycle, 0°for 1 cycle

70% for 25 cycles;

Single phase: 0% for 250 cycle

Power frequency magnetic field IEC 61000-4-8| 30 A/m

50 Hz / 60 Hz

| 30 A/m

50 Hz / 60 Hz

Conduced RF IEC61000-4-6| 0,15 MHz – 80 MHz 3 V

ISM and amateur radio bands between 0,15 MHz and 80 MHz 6 V

| For AC power port:

3 Vrms

6 Vrms (in ISM and amateur radio bands) 80% AM at 1 KHz

Radiated RF IEC61000-4-3| 10 V/m

80 MHz – 2,7 GHz

80% AM at 1 kHz

| 10 V/m

80 MHz – 2,7 GHz

80% AM at 1 kHz

NOTE UT is the a.c. mains voltage prior to application of the test level.

Table 3

Guidance and manufacturer’s declaration – electromagnetic Immunity

Radiated RF IEC61000-4-3

(Test specifications for ENCLOSURE PORT IMMUNITY to

RF wireless communicati- ons equipment)

| Test Frequency (MHz)| Band (MHz)| Service| Modulation| Modulation (W)| Distance (m)| IMMUNITY TEST LEVEL

(V/m)

385| 380-390| TETRA 400| Pulse modulation b) 18 Hz| 1.8| 0.3| 27
450| 430-470| GMRS 460,

FRS 460

| FM c) ±5 kHz deviation

1 kHz sine

| 2| 0.3| 28
710| 704-787| LTE Band 13,

17

| Pulse modulation b) 217 Hz| 0.2| 0.3| 9
745
780
810| 800-960| GSM 800/900, TETRA 800,

iDEN 820,

CDMA 850,

LTE Band 5

| Pulse modulation b) 18 Hz| 2| 0.3| 28
870
930
1720| 1700-

1990

| GSM 1800;

CDMA 1900;

GSM 1900; DECT;

LTE Band 1,

3,

4,25; UMTS

| Pulse modulation b) 217 Hz| 2| 0.3| 28
1845
1970
2450| 2400-

2570

| Bluetooth, WLAN, 802.11

b/g/n, RFID 2450, LTE

Band 7

| Pulse modulation 217 Hz| 2| 0.3| 28
5240| 5100-

5800

| WLAN 802.11

a/n

| Pulse modulation 217 Hz| 2| 0.3| 9
5500
5785

Contact Dario Customer Support Monday to Friday
9:00 AM ­ 9:00 PM EST 1-800-895-5921
Distributed by DarioHealth Corp
18 W 18th St, New York, NY 10011
Toll Free :1-800-895-5921 (Mon to Fri / 9AM to 9PM EST)
For assistance outside of these hours, please contact your healthcare professional

References

• MyDario - Refund and Return Policy
• MyDario Support | Dario's Help Center

Read User Manual Online (PDF format)

Download This Manual (PDF format)

Download this manual  >>