Dario Td-3128b Blood Pressure Monitoring System Instruction Manual

DARIO TD-3128B Blood Pressure Monitoring System

Distributed by DarioHealth Corp.
18 W 18th St,
New York, NY 10011
Made in Taiwan
Toll Free:1-800-895-5921(Mon to Fri / 9AM to 9PM EST)
For assistance outside of these hours, please contact your healthcare professional.

Read instructions before use.
Keep away from sunlight.
311-3128200-018

Dear Dario Blood Pressure System Owner:

Thank you for purchasing the Dario Blood Pressure Monitoring System. This manual provides important information to help you to use this system correctly. Before using this product, please read the following contents thoroughly and carefully.
With the compact size and easy operation of this Dario Blood Pressure Monitoring System, you can easily monitor your blood pressure by yourself at any time or place. In addition, this system can help you and your healthcare professionals to monitor and adjust your treatment plans, and keep your blood pressure under control.
If you have other questions regarding this product, please contact the place of purchase.

IMPORTANT SAFETY PRECAUTIONS

READ THIS BEFORE USE

1. Use this device ONLY for the intended use described in this manual.
2. Do NOT use accessories which are not specified by the manufacturer.
3. Do NOT use the device if it is not working properly or damaged.
4. Do NOT use under any circumstances on newborns or infants.
5. This device does NOT serve as a cure for any symptoms or diseases. The data measured are for reference only. Always consult your doctor to have the results interpreted.
6. Keep the equipment and its flexible cord away from hot surfaces.
7. Do NOT apply the cuff to areas other than the place directed.
8. Use of this instrument in a dry environment, especially if synthetic materials are present (synthetic clothing, carpets etc.) may cause damaging static discharges that may cause erroneous results.
9. Do not use this instrument in close proximity to sources of strong electromagnetic radiation, as these may interfere with the accurate operation.
10. Proper maintenance is essential to the longevity of your device. If you are concerned about your accuracy of measurement, please contact local customer service for help.

KEEP THESE INSTRUCTIONS

BEFORE YOU BEGIN

INTENDED USE

The Dario Blood Pressure Monitoring System is intended to be used to measure the systolic and diastolic blood pressure and pulse rate by using a non-invasive technique in which an inflatable cuff is wrapped on the upper arm. This system should only be used for the testing on people over 18 years of age and over.
The Dario Blood Pressure Monitoring System (model no. DH-1160 and DH-1165) provides Bluetooth transmission.

TEST PRINCIPLE

Blood pressure is measured non-invasively at the arm based on oscillometric method.
This device is NOT able to take measurements in the presence of common arrhythmia, such as atrial or ventricular premature beats or atrial fibrillation. It may produce reading error.

METER OVERVIEW

Pressure Cuff

❶ DISPLAY SCREEN
❷ M BUTTON
Enter the meter memory.
❸ USER SELECTION BUTTON
Assist you with user number selection.
❹ ON/OFF BUTTON
❺ BATTERY COMPARTMENT
❻ AC ADAPTER PORT
Connect to a power supply.
❼ AIR JACK
❽ BT INDICATOR
Download test results with a Bluetooth connection.
❾ PRESSURE CUFF
❿ AIRTUBE
⓫ AIR PLUG
Connect to air jack.

DISPLAY SCREEN

❶ Error Warning
❷ Systolic Pressure Value
❸ Diastolic Pressure Value
❹ Low Battery Symbol
❺ Movement During Measurement
❻ Memory Mode Symbol
❼ Pulse Rate Symbol
❽ User Number
❾ Time& Date
❿ Systolic Pressure Symbol
⓫ Diastolic Pressure Symbol
⓬ Units of Blood Pressure
⓭ AC Adaptor Symbol
⓮ Average
⓯ Pulse Rate

SETTING THE METER

Before using your meter for the first time or if you change the meter battery, you should check and update these settings. Make sure you complete the steps below and save the desired settings.

Entering the Setting Mode

Start with the meter off. Press and firmly hold for 3 seconds until the meter turns on.

Setting the Date and the Time

With the year flashing, press until the correct year appears. Press to set.

With the month flashing, press until the correct month appears. Press to set.

With the day flashing, press until the correct day appears.
Press to set.

With the hour flashing, press until the correct hour appears.
Press to set.

With the minute flashing, press until the correct minute appears.
Press to set.

Setting the Time Format

Press to select the desired time format — 12h or 24h.
Press to set.

Setting the Unit of Measurement

Press to select mmHg or KPa.
Press to set.

Delete The Memory

While “dEL” and a flashing “” symbol appears on the display, if you do not wish to delete the saved results, press to skip this step.
To delete ALL the results, press twice. “”and “ ” are displayed on the meter, which indicates that all results have been deleted.

Enter the Bluetooth Pairing

If you wish to enter the pairing mode, with “PAr OFF” shows on the meter, press once and the meter will display “PAr On” to enable Bluetooth pairing mode.

Congratulations! You have completed all settings!

USER NUMBER SELECTION

This system stores blood pressure measurements for up to four users. Each user’s test results are stored separately under each user number.

1. Press to select the desired user number.
2. Press to confirm. The monitor will repeat the selected user number and then turn off automatically.

TESTING YOUR BLOOD PRESSURE

BEFORE MEASUREMENT

• Avoid caffeine, tea, alcohol and tobacco for at least 30 minutes before measurement.
• Wait 30 minutes after exercising or bathing before measurement.
• Sit or lie down for at least 10 minutes before measuring.
• Do not measure when feeling anxious or tense.
• Take a 5-10 minutes break between measurements. This break can be longer if necessary, depending on your physical condition.
• Keep the records for your healthcare provider as reference.
• Blood pressure naturally varies between each arm. Always measure your blood pressure on the same arm.

FITTING THE CUFF PROPERLY

1. Connect the air plug of the tubing to the air jack of the meter.
   
2. Assemble the cuff as shown. The smooth surface should be inside of the cuff loop and the metal D-ring should not touch your skin.
3. Stretch your left (right) arm in front of you with your palm facing up. Slide and place the cuff onto your arm with the air tube and artery mark region toward the lower arm.
   Wrap and tighten the cuff above your elbow. The bottom edge of the cuff should be approximately 0.8” to 1.2” (2 cm to 3 cm) above your elbow. Align the tube over the main arteries on the inside.
   
4. Leave a little free space between the arm and the cuff; you should be able to fit two fingers between them. Clothing must not restrict the arm. Remove all clothing covering or constricting the measurement arm.
   
5. Press the hook material firmly against the pile material. The top and bottom edges of the cuff should be tightened evenly around your upper arm.
   

PROPER MEASUREMENT POSITION

1. Sit down for at least 10 minutes before measuring.
2. Place your elbow on a flat surface. Relax your hand with the palm facing up.
3. Make sure the cuff is about the same height as the location of your heart.
   Press . Remain still and do not talk or move during the measurement.

   WARNING If the cuff is relatively lower (higher) than the heart, the obtained blood pressure value could be higher (lower) than the actual value. A 15 cm difference in height may result in an error around 10 mmHg.

4. Measurement is in progress. After the meter is turned on, the cuff will begin to inflate automatically

TAKING MEASUREMENTS

Always apply the pressure cuff before turning on the meter.

1. Press . All the LCD symbols will appear. Press to select user ““(numbers from 1 to 4) whose test reading will be stored in its memory. Then the cuff will begin to inflate automatically.
   
2. The heart symbol “ “will flash when pulse is detected during the measurement.
3. After the measurement, the meter displays the systolic pressure, diastolic pressure and pulse rate.
   
4. Press   to switch off or it will switch off automatically after being idle for 3 minutes.
   
5. The meter will enter Bluetooth mode automatically.
   

AVERAGING MEASUREMENT MODE

Always apply the pressure cuff before turning on the meter.

1. Press and hold until the meter displays “AVERAGE’: then press to select user “” (numbers from 1 to 4) whose test reading will be stored in its memory. Then the cuff will begin to inflate automatically.
   
2. After the first measurement is completed, the meter will start counting down before the second measurement begins. The number on the right represents the remaining countdown between each measurement. The meter will take three (3) measurements consecutively with intervals of 20 seconds.
   
   
3. After taking three measurements, the results are averaged to produce the blood pressure measurement with “AVERAGE” symbol display on the meter. Press to turn off the meter.
   

METER MEMORY

Your meter stores the 400 most recent blood pressure test results along with respective dates and times in the meter memory. To recall the memory, start with the meter off.

REVIEWING TEST RESULTS

1. Press and release
   The user symbol (numbers from 1 to 4) appears first, press to select which one you used to store in the memory.Press again, and the first reading you see is the last blood pressure result along with date and time.
   
2. Press again, and the first reading you see is the last blood pressure result along with date and time.
3. Press Review all test results stored in the meter.
   
4. Exit the memory
   Press and the meter will turn off.
   

APP CONNECTION

Data Transmission via Bluetooth

You can transmit your blood pressure monitoring data from the meter to your smart mobile device via Bluetooth. Please contact your local customer service or place of purchase for assistance.
Please note that you must complete the pairing between meter and Bluetooth receiver before transmitting data.

Pairing with your mobile device

1. Turn on the Bluetooth function on your mobile device.
2. Start with the meter off. Press and firmly hold for 3 seconds until the meter turns on.” PCL” will appear on the meter.
3. Open your Dario App on your mobile device. Go to MENU ->SETTINGS -> CONNECTED APPS & DEVICES. Enable the “Dario Blood Pressure Monitoring System” connection and follow the app instruction for pairing.
4. After successfully pairing the app with the device, the Bluetooth function of meter shall be on before transmitting the data to your app.
   Bluetooth indicator on the blood pressure monitor:

Bluetooth indicator on the blood pressure monitor:

MAINTENANCE

BATTERY

Your meter comes with four (4)1.SV AA size alkaline batteries.

Low Battery Signal

The meter will display either of the two messages below to alert you when the meter power is getting low.

1. The symbol appears along with display messages:
   The meter is functional and the result remains accurate, but it is time to change the batteries.
   
2. The symbol appears with E-b:
   The power is not enough to do a test. You must change the batteries immediately.
   

Replacing the Battery

To replace the batteries, make sure the meter is turned off.

1. Press the edge of the battery cover and lift it up to remove.
2. Remove the old batteries and replace with four 1.5V AA size alkaline batteries.
3. Close the battery cover.

USING AC ADAPTER

Connect AC adapter to the meter.

1. Connect AC adapter plug to DC adapter jack of the meter.
   
2. Plug AC adapter power plug into an electrical outlet.
   Press to start the measurement.
   

Remove AC adapter from the meter.

1. When the meter is off, remove AC adapter power plug from the electrical outlet.
   
2. Disconnect AC adapter plug from DC adapter jack of the meter.
   

CARING FOR YOUR METER

To avoid the meter attracting dirt, dust or other contaminants, wash and dry your hands thoroughly before use.

Cleaning

• To clean the meter exterior, wipe it with a cloth moistened with tap water or a mild cleaning agent, then dry the device with a soft dry cloth. Do NOT flush with water.
• Do NOT use organic solvents to clean the meter.
• Do NOT wash the pressure cuff.
• Do NOT iron the pressure cuff.

Meter Storage

• Storage condition: -25°( to 70°( (-13°F to 158°F), 10% to 95% relative humidity.
• Always store or transport the meter in its original storage case.
• Avoid dropping or heavy impact.
• Avoid direct sunlight and high humidity.

DETAILED INFORMATION

REFERENCE VALUES

Clinical studies show that adult diabetes is often accompanied by elevated blood pressure. People with diabetes can reduce their heart risk by managing their blood pressure along with diabetes treatment*1.
Monitoring your routine blood pressure trend helps you to know your body condition. Human blood pressure naturally increases after reaching middle age. This symptom is a result of continuous ageing of the blood vessels. Further causes include obesity, lack of exercise and cholesterol (LDL) adhering to the blood vessels. Rising blood pressure accelerates hardening of the arteries, and the body becomes more susceptible to apoplexy and coronary infarction. Categories of blood pressure in adults*2:

Individuals with systolic blood pressure and diastolic blood pressure in two categories should be designated to the higher blood pressure category.

*1. American Diabetes Association: The Diabetes-Heart Disease Link Surveying Attitudes, Knowledge and Risk (2002)
*2: Whelton PK, Carey RM, Aronow WS, et al. 2017 ACC/ AHA/ AAPA/ ABC/ ACPM/ AGS/ APhA/ ASH/ ASPC/ NMA/PCNA guideline for the prevention, detection, evaluation, and management of high blood pressure in adults: a report of the American College of Cardiology/ American Heart Association Task Force on Clinical Practice Guidelines. Hypertension. 2018;71:e13-115

SYSTEM TROUBLESHOOTING

If you follow the recommended action but the problem persists, or error messages other than the ones below appear, please call your local customer service. Do not attempt to repair by yourself and never try to disassemble the meter under any circumstances.

ERROR MESSAGES

MESSAGE	CAUSE	WHAT TO DO
	Inflation or pressure error.	Please contact local customer service for help.
	Blood pressure measurement error.	Refit cuff tightly and correctly. Relax and repeat the measurement. If error still remains, contact local customer service for help.
	Appears when the cuff deflates too slow.	Please contact local customer service for help.
	Appears when the cuff deflates too fast.
	Problems with the meter.	Review the instructions and repeat the test. If the meter still does not work, please contact the local customer service for help.
	Batteries are too low.	Repeat with new batteries or input AC adapter.
	Bluetooth transmission errors.	Please contact local customer service for help.

TROUBLESHOOTING

1. If no display appears after pressing .
   

   POSSIBLE CAUSE	WHAT TO DO
   Batteries exhausted.	Replace the batteries.
   Batteries incorrectly installed or absent.	Check that the batteries are correctly installed.

2. If the heart rate is higher/lower than user’s average:
   

   POSSIBLE CAUSE	WHAT TO DO
   Movement during measurement.	Repeat measurement.
   Measurement taken just after exercise.	Rest at least 30 minutes before repeating measurement.

3. If the result is higher/lower than user’s average measurement:
   

   POSSIBLE CAUSE	WHAT TO DO
   May not be in correct position while measuring.	Adjust to the correct position to measure.
   Blood pressure naturally varies from time to time.	Keep in mind for next measurement.

4. If the cuff inflates again while measuring:
   

   POSSIBLE CAUSE	WHAT TO DO
   Cuff is not fastened.	Fasten the cuff again.
   If user’s blood pressure is higher than the pressure the device has inflated, the device will automatically increase the pressure and start to inflate again. Stay relaxed and wait for the measurement.

5. If the measurement is not transmitted to the mobile app:
   

   POSSIBLE CAUSE	WHAT TO DO
   Mobile App is not connected.	Follow the steps in the “APP CONNECTION” section to connect the monitor to the mobile App.
   Measurement is not done on user number 1.	Select user 1 and measure again.
   App is not open while taking a measure.	Make sure that while taking a measurement the mobile app is open and within a distance of up to 3 fit from the monitor.

SPECIFICATIONS

SYSTEM PERFORMANCE

Model no.: DH-1160 (Medium Cuff) and DH-1165 (Large Cuff)
Power Source: Four l .SV AA alkaline batteries
Size of Meter w/o Cuff: 141 (L) x 121 (W) x 72 (H)mm, 350g without batteries.
Cuff Size: M (medium): 24-35 cm (9.4-13.8 inches) with air tube 80 cm.
L (Large): 9.4-1 ?Inch (24-43cm) with air tube 80cm.
Memory: Maximum 400 memory records
External Output: Bluetooth
Power Saving: Automatic power off if system idle for 3 minutes
Operating Conditions: S°C to 40°C (41 °F to 104°F), 15% to 93% relative humidity, 700 hPa to 1060 hPa
Storage /Transportation Conditions: -25°C to 70°C (-13°F to 1S8°F),10% to 95% relative humidity
Power Supply Input: DC+ 6V / 1 A (max) via Power Plug
IP Classification: IP21
Expected Service Life: 3 yea rs

BLOOD PRESSURE MEASUREMENT PERFORMANCE

Systolic Measurement Range: 60 mmHg -255 mm Hg
Diastolic Measurement Range: 30 mmHg -195 mm Hg
Pulse Rate Measurement Range: 40-199 beats I minute
Accuracy of Pressure: +3 mmHg or +2% of reading
Accuracy of Pulse Rate: +4% of reading
Measurement Unit: Either mm Hg or KPa

This device has been tested to meet the electrical and safety requirements of:
IEC/EN 60601-1, IEC/EN 60601-1-2, EN 301 489-17, EN 300 328.

Reference to Standards:

• EN 1060-1 /-3, NIBP-requirements
• IEC60601-1 General requirement for safety
• IEC60601-1-2 Requirements for EMC
• EN 1060-4, NIBP clinical investigation
• AAMI /ANSI/ IEC 80601-2-30, ANSI/AAMI/ISO 81060-2, NIBP requirements

FEDERAL COMMUNICATIONS COMMISION (FCC) STATEMENT

15.21
You are cautioned that changes or modifications not expressly approved by the part responsible for compliance could void the user’s authority to operate the equipment.

15.105(b)
Federal Communications Commission (FCC) Statement
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.

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 B 1-30 of 31.
2. This device must accept any interference received, including interference that may cause undesired operation of the device.

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. This equipment should be installed and operated with a minimum distance of 20 centimeters between the radiator radiation source and your body.

M nuf cturer dec r tion e ectrom gnetic immunity
The DH-1160 and DH-1165 is intended for use in the electromagnetic environment (for home healthcare) specified below. The customer or the user of the DH-1160 and DH-1165 should assure that it is used in such and environment.
Immunity test	IEC 60601 test level	Compliance level	Electromagnetic environment-guidance (for home healthcare environment)
Conducted RF IEC 61000-4-6	3 Vrms: 0,15 MHz – 80 MHz 6 Vrms: in ISM and amateur radio bands between 0,15 MHz and 80 MHz	3 Vrms: 0,15 MHz – 80 MHz 6 Vrms: in ISM and amateur radio bands between 0,15 MHz and 80 MHz	Portable and mobile RF communications equipment should be used no closer to any part of the DH-1160 and DH-1165 including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Recommended separation distance: d = 1,2 √P d = 1,2 √P  80 MHz to 800 MHz d = 2,3 √P 800 MHz to 2,7 GHz Where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in metres (m).Interference may occur in the vicinity of equipment marked with the following symbol:
Radiated RF IEC 61000-4-3	80 % AM at 1 kHz 10 V/m 80 MHz – 2,7 GHz 80 % AM at 1 kHz	80 % AM at 1 kHz 10 V/m 80 MHz – 2,7 GHz 80 % AM at 1 kHz
NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies. NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.
a) Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the DH-1160 and DH-1165 is used exceeds the applicable RF compliance level above, the DH-1160 and DH-1165 should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the DH- 1160 and DH-1165. b) Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.