Garmin INDEX BPM Manual

Introduction

The Index BPM device is a standalone device that measures and displays blood pressure and pulse rate. You are not required to connect the device to a smartphone app. The optional smartphone app can only be used to store data for personal record keeping.

Clinical Benefit
Home blood pressure monitoring allows you to participate in your own health care. It helps reduce health care costs, and can improve both the quality and outcome of hypertension management. Being able to monitor your blood pressure and pulse allows you to seek medical attention early when readings are outside the normal range.

Device Overview

1		User
2		Measurement
3		Menu
4		Display
5		Retaining bar
6		Battery cover
7		Cuff
8		Tab

Activating the Device

1. Remove the pull tab from the battery cover.
   
2. Press any button.

Tips for Getting a Good Measurement
The Index BPM device displays your results for few seconds and automatically powers off.

• Read all of the instructions before measuring.
• Avoid eating, smoking, or exercise before measuring.
• After sliding the cuff strap onto your arm, relax for at least 5 minutes before measuring.
• Use the same arm each time you measure.
• Measure at a consistent time of day.
• Avoid tight or bulky clothing that could constrict blood flow.
• Avoid talking during measurements.
• Avoid distractions during measurements.

Tips for Adjusting the Cuff
The Index BPM cuff should be as snug as possible while remaining comfortable.
NOTE: It may be easier to adjust the cuff before wearing it.

• Slide the retaining bar anywhere along the cuff, and fold the cuff over the retaining bar to form a loop.
  TIP: If necessary for a proper fit, you can position the retaining bar on a section of hook material.

Measuring Your Blood Pressure and Pulse Rate
For tips on how to get an accurate measurement of your blood pressure and pulse rate, see Tips for Getting a Good Measurement.
You can take a single measurement (1X), or you can take three consecutive measurements and calculate the average (3X).

1. Unfold the cuff strap.
2. Grip the retaining bar, and loosen the cuff strap by pulling the cuff strap through the retaining bar until it forms a loop.
   TIP: If necessary, pull the retaining bar away from the device to begin forming the loop.
   
3. Fold the cuff strap over the retaining bar, and fasten the hook and loop strap.
4. Place your arm into the cuff loop, and slide the device to your upper arm.
   The device should be above your elbow and level with your heart. The screen should face you.
   TIP: After you have adjusted the cuff to fit properly on your arm, you should be able to slide the fastened cuff on and off without adjusting it for every use.
   
5. If necessary, remove the cuff from your arm, and readjust the cuff so it is snug but comfortable (Tips for Adjusting the Cuff).
   NOTE: If the device is not snug, the measurements may not be accurate.
6. Sit down with your feet flat on the floor.
7. Place your arm on a table or flat surface.
8. Press any button to wake up the device.
9. Select an option:
   • For a 1X measurement, press .
     appears.
   • For a 3X measurement, hold .
     appears.
     NOTE: There is a one minute rest period between each measurement. Do not move or talk until the third measurement is complete.
     The arm cuff automatically inflates and deflates for each measurement. The results appear on the screen.

If you have set up your device with an optional Wi‑Fi^® connection, the measurements are uploaded automatically to your Garmin Connect^™ account.

Stopping a Measurement
You can stop a measurement at any time.

1. Press .
2. Slide the fastened cuff off of your upper arm.

Viewing Your Last Measurement

1. Press > .
   appears on the screen.
2. Press .

Smart Features

Connecting to a Wi‑Fi Network
NOTICE
Do not attempt to pair the device with a smartphone that is not your personal device.
Do not attempt to connect the device to an unsecured Wi‑Fi network, or a Wi‑Fi network that does not have a password.
Do not share your account credentials or password.
You must connect your device to the Garmin Connect app on your smartphone before you can connect to a Wi‑Fi network.
It is optional and not required to use a Wi‑Fi network with your Index BPM device. Your Index BPM device can sync measurements with the Garmin Connect app while connected to a Wi‑Fi network.
The Index BPM device uses security measures to prevent data breaches. For example, the Garmin Connect app uses an authentication key to ensure that you can only pair the device to one smartphone at a time, and you must enter a 6-digit pairing code displayed on your device to complete secured and bonded pairing.

1. Move within range of a Wi‑Fi network.
2. Press any button to wake up the device.
3. Press .
   appears.
4. Press .
5. From the Garmin Connect app, select the options menu, and select Add Device.
6. Enter the security code displayed on your device.
7. Enter a name for your device.
8. Select an available Wi‑Fi network, and enter the login details.

Changing the Wi‑Fi Network
You can add or change connected Wi‑Fi networks from the Garmin Connect app on your phone. Secondary users cannot manage Wi‑Fi networks.

1. Move within range of a Wi‑Fi network.
2. Press any button to wake up the device.
3. Press .
   appears.
4. Press .
5. From the Garmin Connect app, select .
6. Select Garmin Devices, and select your device.
7. Select Connectivity > Wi-Fi > My Networks.
8. Follow the on-screen instructions.

Garmin Connect App
It is optional and not required to use the Garmin Connect app with your Index BPM device. The Garmin Connect app allows you to view blood pressure measurements, create notes for your measurements, invite people to use your device, and manage blood pressure reading reminders.
The Index BPM device runs in standalone mode until you download and pair the device with the Garmin Connect app.

Dowloading the App
It is optional and not required to use the Garmin Connect app with your Index BPM device.

1. On your compatible smartphone, open the application store, and search for the Garmin Connect app.
2. Install the app.
   See the owner's manual for your smartphone for more information.

Pairing Your Device with the Garmin Connect App
You can add the Index BPM device to your Garmin Connect account.

1. From the app store on your smartphone, install and open the Garmin Connect app.
2. Select an option to add your device to your Garmin Connect account:
   • If this is the first device you have paired with the Garmin Connect app, follow the on-screen instructions.
   • If you have already paired another device with the Garmin Connect app, from the settings menu, selectGarmin Devices > Add Device, and follow the on-screen instructions.
3. To enter pairing mode on your device, press any button to wake up the device, and press . appears.
4. Press .
5. Follow the on-screen instructions on the Garmin Connect app.
   New measurements automatically upload to the Garmin Connect app.

Inviting Secondary Users
Before you can invite secondary users, the secondary users must install the Garmin Connect app on their smartphone and create an account.
You can invite up to 15 secondary users to create a profile and take measurements on your device using the Garmin Connect app.

1. From the Garmin Connect app on your smartphone, follow the on-screen instructions to invite secondary users.
   The secondary user receives an email inviting them to use your device.
2. From the secondary user's smartphone, accept the email invitation, and follow the on-screen instructions.
3. Take a measurement on your Index BPM device.
   The Index BPM device syncs and the new user's profile becomes available.

Changing the User Profile
Before you can change the user profile, you must complete the invitation process for secondary users and sync the device with your Garmin Connect account.

1. Press any button to wake up the device.
2. Press until the user's name appears.
3. Take a measurement.
   If you have set up your device with an optional Wi‑Fi connection, the measurements upload to the secondary user's Garmin Connect account automatically.

Device Information

Resetting the Device
Resetting the device erases all data and connections.
While the device is off, hold and for 10 seconds.
appears, and the device resets.

Replacing the Batteries
The device operates on four AAA batteries.

1. Press the battery cover button located behind the cuff.
2. Remove the battery cover.
3. Remove the batteries from the device.
4. Insert the new batteries, observing polarity.
   
5. Replace the battery cover.

Viewing the Software Version

1. Press any button to wake up the device.
2. Press until appears on the screen.
3. Press .

Device Care
NOTICE
Avoid extreme shock and harsh treatment, because it can degrade the life of the product.
Do not store the device where prolonged exposure to extreme temperatures can occur, because it can cause permanent damage.
When you do not plan to use the device for several months, remove the batteries.
Do not use a sharp or abrasive object to clean the device.
Avoid chemical cleaners, abrasive cleaners, solvents, and insect repellents that can damage plastic components and finishes.
Avoid leaving the device in direct sunlight.

Cleaning the Device
If necessary, you can clean the surface of the device to remove unwanted residue, lint, and dust.
NOTE: You should clean the device at least once a year.

1. Clean the surface of the device using a cloth dampened with clean water.
2. Wipe the device dry.

Storing the Device

• Roll the cuff strap until it is against the device, and secure the cuff with the hook and loop tab.
• Store the device in a cool, dry place, away from direct sunlight.
• Remove the batteries if you do not plan to use the device for more than 3 months to prevent battery leakage.

Maintenance

• No firmware update is needed during the service life of this product.
• On very rare occasions, you might need to reinstall the firmware on the device due to hardware malfunction. In this case, the intended use remains unchanged.
• Any modification or change to the firmware is prohibited.

Specifications

Symbol Definitions

These symbols and abbreviations may appear on the device labels.

		Do not use this product if you have an implanted pacemaker.
		Read the instructions before use.
		Applied part, type BF.
		Manufacturer
		Importer
		Distributor
		Class II symbol
		Low battery warning. Indicates that the battery is lower than 50%.
		Battery is too low to switch the device on and should be changed immediately.
		Universal recycling symbol.
		Storage and transportation conditions.
		Storage and transportation conditions.
		Bluetooth symbol.
		Do not use this device in an MR (magnetic resonance) environment.
IP22		The device is protected against solid foreign objects greater than 12.5 mm (0.49 in.). The device is protected against water sprayed up to 15° from vertical.
S/N		Serial number.
SYS / DIA		Systolic blood pressure in mmHg/ diastolic blood pressure in mmHg.
BPM		Heart beats per minute during a measurement.
		Medical device.
		Unique device identification.

Error Codes

Error codes may appear on the device screen to indicate a problem with the device (Tips for Getting a Good Measurement). If your Index BPM device displays an error code, you should remove the device from your arm and turn the device off and on before attempting another measurement.

	The device battery level is low.
E1	The device did not detect a measurement.
E2	The cuff did not inflate properly or has a leak.
E3	The measurement is incorrect.
E4	The device timed out while the cuff was inflating or deflating.
E5	The cuff is partially inflated.
E6	The measurement exceeded the maximum blood pressure value.
E7	The device timed out while attempting to connect to the Garmin Connect app or a Wi‑Fi network.
E8	The device experienced an internal communications error.
E9	The software update did not install properly.
E10	The device timed out.
X	The device timed out while attempting to upload a measurement or complete setup.

Manufacturer Information

• Ya Horng Electronic Co., Ltd.
• www.yahorng.com
• +886-6593-2201
• healthcare@yahorng.com
• No. 35, Shalun, Anding Dist., Tainan City, TAIWAN

Authorized Representative Information

• Kahl Handelsvertretung
• Isarstr. 33 40699 Erkrath, Germany

Importer Information

• Tacx^® B.V.
• medicalcompliance@garmin.com
• De Boeg 2, Oegstgeest, 2343 HK The Netherlands

Important Safety and Product Information

Read all instructions carefully before installing and using the Index BPM device.

User Restrictions

• This product is designed for use by non-healthcare professionals in a home environment.
• Do not use this product if you are under the age of 18.
• Do not use this product if you are over the age of 75.
• Do not use this product if your left arm circumference is greater than 42 cm (16.5 in.) or less than 22 cm (8.6 in.).
• Do not use this product if you are pregnant, if you think you may be pregnant, or if you are pregnant and experiencing preeclampsia or toxemia.
• Do not use this product if you have a pacemaker or other internal electronic device.

Health Warnings

• Always consult your physician before beginning or modifying any exercise program.
• Measurements provided by this device are for reference only. Garmin^® is not responsible for the consequences of erroneous information. This device is not intended to diagnose, treat, cure, or prevent any disease.
• Do not adjust your medication based on measurements provided by this device. Take medication as prescribed by your physician. Only a physician is qualified to diagnose and treat high blood pressure.
• This device is not for use in an oxygen-rich environment.
• This product is not intended to undergo medical device sterilization.
• Do not use this device on the same limb as another health monitoring device.
• If you have had a mastectomy, do not use this device on the arm on the same side as your mastectomy.

Battery Warnings

Replaceable alkaline batteries should be used with this device.
If these guidelines are not followed, batteries may experience a shortened life span or may present a risk of damage to the device, fire, chemical burn, electrolyte leak, and/or injury.

• Do not expose the device or batteries to fire, explosion, or other hazard.
• BATTERIES ARE HAZARDOUS AND MUST BE KEPT AWAY FROM CHILDREN. NEVER PUT NEW OR USED BATTERIES IN MOUTH OR IN ANY PART OF THE BODY. Severe or fatal injuries can occur within 2 hours if swallowed or placed inside the body. If this occurs or is suspected, seek medical attention immediately.
• Do not disassemble, modify, remanufacture, puncture, or damage the device or batteries.
• Only replace batteries with correct replacement batteries. Using other batteries presents a risk of fire or explosion.
• Do not mix battery types.
• Do not mix old and new batteries.

Incident Reports
NOTICE
In case of a serious device-related incident, report all details to the manufacturer and the manufacturer's authorized representative.

Battery Notice
NOTICE
Contact your local waste disposal department to dispose of the device/batteries in accordance with applicable local laws and regulations.

Intended Use
The Index BPM device is a tubeless blood pressure monitor. This is a medical device intended to measure systolic and diastolic blood pressure and pulse rate. The device is designed for measurement and operation by adults age 18 to 75. The device is designed to measure adults (age 18 to 75) with an upper arm circumference of 22 to 42 cm (8.6 to 16.5 in.). The Index BPM device is not intended to diagnose any disease. Only a physician is qualified to diagnose and treat diseases, including high blood pressure. You should contact your physician if the device displays hypertensive or high blood pressure values. There are no known side effects for using this device.