INDEX
™
BPM
Owner’s Manual
© 2024 Garmin Ltd. or its subsidiaries
All rights reserved. Under the copyright laws, this manual may not be copied, in whole or in part, without the written consent of Garmin. Garmin reserves the right to change
or improve its products and to make changes in the content of this manual without obligation to notify any person or organization of such changes or improvements. Go to
www.garmin.com for current updates and supplemental information concerning the use of this product.
Garmin
®
, the Garmin logo, and Tacx
®
are trademarks of Garmin Ltd. or its subsidiaries, registered in the USA and other countries. Garmin Connect
™
and Garmin Index
™
are
trademarks of Garmin Ltd. or its subsidiaries. These trademarks may not be used without the express permission of Garmin.
The BLUETOOTH
®
word mark and logos are owned by Bluetooth SIG, Inc. and any use of such marks by Garmin is under license. Wi‑Fi
®
is a registered mark of Wi-Fi Alliance
Corporation. Other trademarks and trade names are those of their respective owners.
This device is in conformity with European Union Medical Device Regulation 2017/745. EC Certificate Number: C539652.
This device was manufactured by Ya Horng Electronic Co., Ltd.
M/N: BP707
Table of Contents
Important Safety and Product
Information...................................... 1
User Restrictions..................................... 1
Health Warnings...................................... 1
Battery Warnings..................................... 1
Incident Reports...................................... 2
Battery Notice.......................................... 2
Intended Use............................................2
Introduction......................................2
Clinical Benefit.........................................2
Device Overview............................... 3
Activating the Device.............................. 4
Tips for Getting a Good
Measurement.......................................... 4
Tips for Adjusting the Cuff..................... 5
Measuring Your Blood Pressure and
Pulse Rate................................................ 6
Smart Features.................................7
Connecting to a Wi‑Fi Network............... 7
Changing the Wi‑Fi Network................... 8
Garmin Connect App............................... 8
Inviting Secondary Users........................ 9
Changing the User Profile....................... 9
Device Information........................... 9
Resetting the Device............................... 9
Replacing the Batteries......................... 10
Viewing the Software Version.............. 10
Device Care............................................10
Specifications........................................12
Symbol Definitions................................ 13
Error Codes............................................ 15
Manufacturer Information.................... 15
Authorized Representative
Information............................................ 15
Importer Information............................ 15
Radio Frequency Radiation Exposure.. 15
RF Statement......................................... 16
Software License Agreement............... 16
Consumer Limited Warranty.................17
Disposal................................................. 18
Guidance and Manufacturer's
Declaration - Electromagnetic
Emissions.............................................. 19
Declaration - Electromagnetic Emissions
and Immunity.........................................20
Residual Risks....................................... 24
EC Declaration of Conformity...............25
Table of Contents i
Important Safety and Product Information
WARNING
Read all instructions carefully before installing and using the Index BPM device.
User Restrictions
WARNING
• 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
WARNING
• 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
WARNING
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.
Important Safety and Product Information 1
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.
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.
2 Introduction
Device Overview
User
Measurement
Menu
Display
Retaining bar
Battery cover
Cuff
Tab
Device Overview 3
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.
4 Device Overview
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.
• For larger arms, position the bar further away from the main housing.
• Once the cuff has been adjusted for a proper fit, keep the loop formed so you can slide the blood pressure
monitor on and off during usage without further adjustment.
Device Overview 5
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, page4.
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, page5).
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.
6 Device Overview
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.
Smart Features 7
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 or .
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, select
Garmin 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.
8 Smart Features
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.
Device Information 9
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.
10 Device Information
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.
Device Information 11
Specifications
Display 3.3 cm (1.3 in.) OLED
Cuff pressure range From 0 to 280 mmHg
Measurement range
Systolic blood pressure: from 60 to 250 mmHg
Diastolic blood pressure: from 40 to 180 mmHg
Measurement method Oscillometric
Accuracy
Blood pressure value: ± 3 mmHg or ± 2%
Pulse: ± 5%
Power rating DC 6 V, 4 1.5 V LR03 AAA batteries
Arm circumference From 22 to 42 cm (from 8.6 to 16.5 in.)
Weight 280 grams (0.62 lb.) without batteries
Dimensions 150 x 60 x 80 mm (5.9 x 2.4 x 3.1 in.)
Battery life Up to 9mo.
Operating temperature range
From 10° to 40°C (from 50° to 104°F)
From 15% to 90% relative maximum humidity
Maximum altitude: 2,000 m (6561.68 ft.)
Storage temperature range
From -25° to 70°C (from -13° to 158°F)
From 10% to 95% relative maximum humidity
Maximum altitude: 2,000 m (6561.68 ft.)
From 800 to 1,060 hPa
Transmission method Bluetooth
®
low energy 5.0
Wireless network capability IEEE 802.11 b/g/n
Warranty One yr.
Applied part Type BF (upper arm cuff)
Contents
BP707
4 AAA batteries
Cuff (attached)
Quick start manual
Expected service life 3 yr.
Power on or wake up time 5 sec.
Measurement cycle time From 50 to 60 sec., according to pressure value
Wireless frequency
Wi-Fi: 2412 to 2472 MHz @18.04 dBm maximum
Bluetooth Low Energy: 2402 to 2480 MHz @ -2.33 dBm
Bluetooth Low Energy 5.0
Bluetooth Low Energy range <9.1 m (30 ft.) (typical)
Maximum number of connections 1 smartphone
Wireless networks b/g/n 2.4 GHz only
12 Device Information
Wireless network security WPA2
Wireless network range <30 m (100 ft.) (typical)
Maximum number of wireless networks 7 stored
Symbol Definitions
These symbols and abbreviations may appear on the device labels.
Device Information 13
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
WEEE disposal and recycling symbol. The WEEE symbol is attached to the product in compliance
with the EU directive 2012/19/EU on Waste Electrical and Electronic Equipment (WEEE). It is
intended to deter the improper disposal of this product and to promote reuse and recycling.
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.
FCC certification mark.
800hPa
1060hPa
95%
10%
Storage and transportation conditions.
-25°C
(-13°F)
70°C
(158°F)
Storage and transportation conditions.
CE certification mark.
Green Dot packaging. A financial contribution has been paid to a qualified national packaging
recovery organization.
Bluetooth symbol.
MR
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.
MD
Medical device.
14 Device Information
UDI
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, page4). 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
• No. 35, Shalun, Anding Dist., Tainan City, TAIWAN
Authorized Representative Information
• Kahl Handelsvertretung
• Isarstr. 33 40699 Erkrath, Germany
Importer Information
• Tacx
®
B.V.
• De Boeg 2, Oegstgeest, 2343 HK The Netherlands
Radio Frequency Radiation Exposure
This device is a portable transmitter and receiver that uses an internal antenna to send and receive low levels
of radio frequency (RF) energy for data communications. The device emits RF energy below the published limits
for portable use when operating in its maximum output power mode and when used with Ya Horng authorized
accessories. To comply with RF exposure compliance requirements, the device should be used as described in
the manual. The device should not be used in other configurations.
Device Information 15
RF Statement
Medical Electrical Equipment requires special precautions regarding ElectroMagnetic Compatibility (EMC) and
needs to be installed and put into service according to the following EMC information.
• Interference may occur in the vicinity of equipment marked with portable and mobile RF communication
equipment (e.g. cell phones) and can affect Medical Electrical Equipment.
• The device uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not
likely to cause any interference in nearby electronic equipment.
• The device is suitable for use in all establishments, including domestic establishments and those directly
connected to the public low-voltage power supply network that supplies buildings used for domestic
purposes.
• Portable and mobile RF communications equipment should be used no closer to any part of the device
than the recommended separation distance, calculated from the equation applicable to the frequency of
the transmitter. The device is intended for use in an electromagnetic environment in which radiated RF
disturbances are controlled.
• Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result
in improper operation. If such use is necessary, this equipment and the other equipment should be observed
to verify that they are operating normally.
Software License Agreement
BY USING THE DEVICE, YOU AGREE TO BE BOUND BY THE TERMS AND CONDITIONS OF THE FOLLOWING
SOFTWARE LICENSE AGREEMENT. PLEASE READ THIS AGREEMENT CAREFULLY.
Garmin Ltd. and its subsidiaries (“Garmin”) grant you a limited license to use the software embedded in this
device (the “Software”) in binary executable form in the normal operation of the product. Title, ownership rights,
and intellectual property rights in and to the Software remain in Garmin and/or its third-party providers.
You acknowledge that the Software is the property of Garmin and/or its third-party providers and is protected
under the United States of America copyright laws and international copyright treaties. You further acknowledge
that the structure, organization, and code of the Software, for which source code is not provided, are valuable
trade secrets of Garmin and/or its third-party providers and that the Software in source code form remains
a valuable trade secret of Garmin and/or its third-party providers. You agree not to decompile, disassemble,
modify, reverse assemble, reverse engineer, or reduce to human readable form the Software or any part thereof
or create any derivative works based on the Software. You agree not to export or re-export the Software to any
country in violation of the export control laws of the United States of America or the export control laws of any
other applicable country.
16 Device Information
Consumer Limited Warranty
THIS LIMITED WARRANTY GIVES YOU SPECIFIC LEGAL RIGHTS, AND YOU MAY HAVE OTHER LEGAL RIGHTS,
WHICH VARY FROM STATE TO STATE (OR BY COUNTRY OR PROVINCE). GARMIN DOES NOT EXCLUDE, LIMIT
OR SUSPEND OTHER LEGAL RIGHTS YOU MAY HAVE UNDER THE LAWS OF YOUR STATE (OR COUNTRY OR
PROVINCE). FOR A FULL UNDERSTANDING OF YOUR RIGHTS, YOU SHOULD CONSULT THE LAWS OF YOUR
STATE, COUNTRY OR PROVINCE.
Non-aviation products are warranted to be free from defects in materials or workmanship for one year from
the date of purchase. Within this period, Garmin will, at its sole option, repair or replace any components that
fail in normal use. Such repairs or replacement will be made at no charge to the customer for parts or labor,
provided that the customer shall be responsible for any transportation cost. This Limited Warranty does not
apply to: (i) cosmetic damage, such as scratches, nicks and dents; (ii) consumable parts, such as batteries,
unless product damage has occurred due to a defect in materials or workmanship; (iii) damage caused by
accident, abuse, misuse, water, flood, fire, or other acts of nature or external causes; (iv) damage caused by
service performed by anyone who is not an authorized service provider of Garmin; (v) damage to a product
that has been modified or altered without the written permission of Garmin; (vi) damage to a product that
has been connected to power and/or data cables that are not supplied by Garmin or damage to a product
that has been connected to AC adapters and cables that are not certified by UL (Underwriters Laboratories)
and are not labeled as Limited Power Source (LPS). In addition, Garmin reserves the right to refuse warranty
claims against products or services that are obtained and/or used in contravention of the laws of any country.
Garmin navigation products are intended to be used only as a travel aid and must not be used for any purpose
requiring precise measurement of direction, distance, location or topography. Garmin makes no warranty as to
the accuracy or completeness of map data.
TO THE MAXIMUM EXTENT PERMITTED BY APPLICABLE LAW, THE WARRANTIES AND REMEDIES CONTAINED
IN THIS LIMITED WARRANTY ARE EXCLUSIVE AND IN LIEU OF, AND GARMIN EXPRESSLY DISCLAIMS,
ALL OTHER WARRANTIES AND REMEDIES, WHETHER EXPRESS, IMPLIED, STATUTORY, OR OTHERWISE,
INCLUDING WITHOUT LIMITATION ANY IMPLIED WARRANTY OF MERCHANTABILITY OR FITNESS FOR
A PARTICULAR PURPOSE, STATUTORY REMEDY OR OTHERWISE. THIS LIMITED WARRANTY GIVES YOU
SPECIFIC LEGAL RIGHTS, AND YOU MAY HAVE OTHER LEGAL RIGHTS, WHICH VARY FROM STATE TO STATE
AND FROM COUNTRY TO COUNTRY. IF IMPLIED WARRANTIES CANNOT BE DISCLAIMED UNDER THE LAWS OF
YOUR STATE OR COUNTRY, THEN SUCH WARRANTIES ARE LIMITED IN DURATION TO THE DURATION OF THIS
LIMITED WARRANTY. SOME STATES (AND COUNTRIES AND PROVINCES) DO NOT ALLOW LIMITATIONS ON
HOW LONG AN IMPLIED WARRANTY LASTS, SO THE ABOVE LIMITATION MAY NOT APPLY TO YOU.
IN NO EVENT SHALL GARMIN BE LIABLE IN A CLAIM FOR BREACH OF WARRANTY FOR ANY INCIDENTAL,
SPECIAL, INDIRECT OR CONSEQUENTIAL DAMAGES, WHETHER RESULTING FROM THE USE, MISUSE OR
INABILITY TO USE THIS PRODUCT OR FROM DEFECTS IN THE PRODUCT. SOME STATES (AND COUNTRIES
AND PROVINCES) DO NOT ALLOW THE EXCLUSION OF INCIDENTAL OR CONSEQUENTIAL DAMAGES, SO THE
ABOVE LIMITATIONS MAY NOT APPLY TO YOU.
If during the warranty period you submit a claim for warranty service in accordance with this Limited Warranty,
then Garmin will, at its option: (i) repair the device using new parts or previously used parts that satisfy Garmin's
quality standards, (ii) replace the device with a new device or a Garmin Recertified device that meets Garmin's
quality standards, or (iii) exchange the device for a full refund of your purchase price. SUCH REMEDY SHALL BE
YOUR SOLE AND EXCLUSIVE REMEDY FOR ANY BREACH OF WARRANTY. Repaired or replaced devices have a
90-day warranty. If the device sent in is still under its original warranty, then the new warranty is 90 days or to
the end of the original 1-year warranty, whichever is longer.
Before seeking warranty service, please access and review the online help resources available on
support.garmin.com. If your device is still not functioning properly after making use of these resources,
contact a Garmin Authorized service facility in the original country of purchase or follow the instructions
on support.garmin.com to obtain warranty service. If you are in the United States, you can also call
1-800-800-1020.
Device Information 17
If you seek warranty service outside of the original country of purchase, Garmin cannot guarantee that the parts
and products needed to repair or replace your product will be available due to differences in product offerings
and applicable standards, laws and regulations. Accordingly, Garmin may, in its sole discretion and subject to
applicable laws, repair your product with comparable parts or replace your product with a comparable Garmin
product (new or a Garmin Recertified replacement), or require you to ship your product to a Garmin Authorized
Service facility in the country of original purchase or to a Garmin Authorized service facility in another country
that can service your product, in which case you will be responsible for complying with all applicable import
and export laws and regulations and for paying all custom duties, V.A.T., shipping fees and other associated
taxes and charges. In some cases, Garmin and its dealers may be unable to service your product in a country
outside of the original country of purchase or return a repaired or replaced product to you in that country due to
applicable standards, laws or regulations in that country.
Online Auction Purchases: Products purchased through online auctions are not eligible for rebates or other
special offers from Garmin warranty coverage. Online auction confirmations are not accepted for warranty
verification. To obtain warranty service, an original or copy of the sales receipt from the original retailer is
required. Garmin will not replace missing components from any package purchased through an online auction.
International Purchases: A separate warranty may be provided by international distributors for devices
purchased outside the United States depending on the country. If applicable, this warranty is provided by
the local in-country distributor and this distributor provides local service for your device. Distributor warranties
are only valid in the area of intended distribution. Devices purchased in the United States or Canada must be
returned to the Garmin service center in the United Kingdom, the United States, Canada, or Taiwan for service
Australian Purchases: Our goods come with guarantees that cannot be excluded under the Australian
Consumer Law. You are entitled to a replacement or refund for a major failure and for compensation for any
other reasonably foreseeable loss or damage. You are also entitled to have the goods repaired or replaced if the
goods fail to be of acceptable quality and the failure does not amount to a major failure. The benefits under our
Limited Warranty are in addition to other rights and remedies under applicable law in relation to the products.
Garmin Australasia, 30 Clay Place, Eastern Creek, NSW 2766, Australia. Phone: 1800 235 822.
Disposal
Actuation of European directives 2011/65/EU, 2012/19/EU, and 2015/863/EU, for the reduction in use of
dangerous substances in electric and electronic devices and for waste disposal. The symbol applied on the
device or its packaging means that at the end of its useful life, the product must not be disposed of with
domestic waste. At the end of the device's useful life, the user must deliver it to a designated collection point for
electric and electronic waste, or give the device back to the retailer when purchasing a new device. Disposing
of the product separately helps protect human health and the environment. The collection and recycling of your
device also helps conserve natural resources. The device and its parts are marked with regard to disposal, as
appropriate, in accordance with national or regional regulations.
18 Device Information
Guidance and Manufacturer's Declaration - Electromagnetic Emissions
The Index BPM is intended for use in the electromagnetic environment specified below. The customer or the
user of the Index BPM device should assure that it is used in such an environment.
Emissions Test Compliance
Electromagnetic Environment -
Guidance
CE emission CISPR11 Group 1
The Index BPM device uses RF
energy only for its internal function.
Therefore, its RF emissions are very
low and are not likely to cause any
interference in nearby electronic
equipment.
RE emissions CISPR11 Class B
The Index BPM device uses RF
energy only for its internal function.
Therefore, its RF emissions are very
low and are not likely to cause any
interference in nearby electronic
equipment.
Harmonic emissions IEC 61000-3-2 Not applicable
The Index BPM device is suitable
for use in all establishments,
including domestic establishments
and those directly connected to
the public low-voltage power supply
network that supplies buildings
used for domestic purposes.
Voltage fluctuations/Flicker
emissions
IEC 61000-3-3
Not applicable
The Index BPM device is suitable
for use in all establishments,
including domestic establishments
and those directly connected to
the public low-voltage power supply
network that supplies buildings
used for domestic purposes.
Device Information 19
Declaration - Electromagnetic Emissions and Immunity
For equipment and systems that are not life-supporting and are specified for use only in a shielded location.
Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result
in improper operation. If such use is necessary, this equipment and the other equipment should be observed
to verify that they are operating normally. Portable RF communications equipment (including peripherals such
as antenna cables and external antennas) should be used no closer than 30 cm (12 in.) to any part of the unit,
including cables specified by the manufacturer. Otherwise, degradation of the performance of this equipment
could result.
The Index BPM device is intended for use in the electromagnetic environment specified in the following table.
The customer or the user of the Index BPM device should assure that it is used in such an environment.
Immunity Test IEC 60601 Test Level Compliance Level
Electromagnetic Environment -
Guidance
Electrostatic Discharge
(ESD)
IEC 61000-4-2
Contact: ±8 kV
Air: ±2 kV, ±4 kV,
±8 kV, ±15 kV
Contact: ±8 kV
Air: ±2 kV, ±4 kV, ±8 kV,
±15 kV
Floors should be wood, concrete,
or ceramic tile. If floors are
covered with synthetic material,
the relative humidity should be
at least 30%.
Electrical fast transient/
burst
IEC 61000-4-4
± 2 kV for power supply
lines
± 1 kV for input/ output
lines
N/A
1
Mains power quality should be
that of a typical commercial or
hospital environment.
Surge
IEC 61000-4-5
+ 0.5kV, +1kV line(s) to
line(s)
+0.5kV, +1kV,+ 2kV
line(s) to earth
N/A
Mains power quality should be
that of a typical commercial or
hospital environment.
Voltage dips, short inter
ruptions, and voltage
variations on power
supply input lines
IEC 61000-4-11
Voltage dips:
0 % UT; 0,5 cycle
0 % UT; 1 cycle
70 % UT; 25/30 cycles
Voltage interruptions:
0 % UT; 250/300 cycles
Voltage dips: N/A
Mains power quality should
be that of a typical commer
cial or hospital environment.
If the user of the Index BPM
requires continued operation
during power mains interrup
tions, it is recommended that the
Index BPM be powered from an
uninterruptible power supply or a
battery.
Power frequency (50/60
Hz) magnetic field
IEC 61000-4-8
30 A/m
50 Hz or 60 Hz
30 A/m
50 Hz and 60 Hz
The Index BPM power frequency
magnetic fields should be at
levels characteristic of a typical
location in a typical commercial
or hospital environment.
The Index BPM device is intended for use in the electromagnetic environment specified in the following table.
The customer or the user of the Index BPM device should assure that it is used in such an environment.
NOTE: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption
and reflection from structures, objects, and people.
1
Not Applicable. The Index BPM is battery-powered, not AC powered.
20 Device Information
Immunity Test IEC 60601 Test Level Compliance Level
Electromagnetic
Environment - Guidance
Conducted
RFIEC 61000-4-6
3 Vrms
150 kHz to 80MHz
6 Vrms:
In ISM and amateur radio
bands between 0,15MHz
and 80MHz 80 % AM at
1kHz
N/A
2
Portable and mobile
RF communications
equipment should be
used no closer to any
part of the INDEX BPM,
including cables, than the
recommended separation
distance calculated from
the equation applicable to
the frequency of the trans
mitter.
Radiated RF IEC
61000-4-3
10 V/m
80MHz - 2,7GHz
80 % AM at 1kHz
10 V/m
80MHz - 2,7GHz
80 % AM at 1kHz
Recommended separation
distance:
d = 1,2
d = 1,2 80MHz to
800MHz
3
d = 2,3 800MHz to
2,7GHz
Where P is the maximum
output power rating of the
transmitter in watts (W)
according to the trans
mitter manufacturer and
d is the recommended
separation distance in
meters (m).
Interference may occur in
the vicinity of equipment
marked with the following
symbol:
The Index BPM is intended for use in an electromagnetic environment (for home healthcare) in which radiated
RF disturbances are controlled. The customer or the user of the Index BPM can help prevent electromagnetic
interference by maintaining a minimum distance between portable and mobile RF communications equipment
(transmitters) and the Index BPM as recommended in the following table, according to the maximum output
power of the communications equipment.
2
Not Applicable. The EUT is operating by battery, no supply for AC mains.
3
At 80 MHz and 800 MHz, the higher frequency range applies.
Device Information 21
Recommended separation distance between portable and mobile RF communications equipment and the
Index BPM
Rated maximum output
power of transmitter W
Separation distance according to frequency of transmitter m
150kHz to 80MHz
d =1,2
80MHz to 800MHz
d =1,2
800MHz to 2,7GHz
d =2,3
0,01 N/A 0,12 0,23
0,1 N/A 0,38 0,73
1 N/A 1,2 2,3
10 N/A 3,8 7,3
100 N/A 12 23
For transmitters rated at a maximum output power not listed above, the recommended separation distance d
in meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where p is
the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer.
NOTE: At 80MHz and 800MHz, the separation distance for the higher frequency range applies.
NOTE: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption
and reflection from structures, objects and people.
The Index BPM is intended for use in the electromagnetic environment (for home healthcare) specified in the
following table. The customer or the user of the Index BPM should assure that it is used in such an environment.
Manufacturer's declaration-electromagnetic immunity test specifications for ENCLOSURE PORT IMMUNITY to
RF wireless communications equipment
Test
frequency
(MHz)
Band (MHz) Service Modulation
Maximum
power (W)
Distance
(m)
IMMUNITY
TEST LEVEL
(V/m)
Compliance
level (V/m
for home
healthcare)
385 380-390 TETRA 400
Pulse modu
lation 18Hz
1,8 0,3 27 27
450 430-470
GMRS 460,
FRS 460
FM
4
±5 kHz
deviation
1kHz sine
2 0,3 28 28
710
704-470
LTE Band
13,17
Pulse modu
lation
217Hz
0,2 0,3 9 9745
780
810
800-960
GSM
800/900
TETRA 800
iDEN 820
CDMA 850
LTE Band 5
pulse modu
lation 18Hz
2 0,3 28 28
870
930
4
As an alternative to FM modulation, 50% pulse modulation at 18 Hz may be used because while it does not represent actual modulation, it would be worst
case.
22 Device Information
Test
frequency
(MHz)
Band (MHz) Service Modulation
Maximum
power (W)
Distance
(m)
IMMUNITY
TEST LEVEL
(V/m)
Compliance
level (V/m
for home
healthcare)
1 720
1 700-1 990
GSM 1800
CDMA 1900
GSM 1900
DECT
LTE Band 1,
2, 3, 4, 25
UMTS
Pulse modu
lation
217Hz
2 0,3 28 28
1 845
1 970
2 450 2 400-2 570
Bluetooth,
WLAN,
802.11
b/g/n, RFID,
2450, LTE
Band 7
Pulse modu
lation
217Hz
2 0,3 28 28
5 240
5 100-5 800
WLAN
802.11 a/n
Pulse modu
lation
217Hz
0,2 0,3 9 95 500
5 785
NOTE: If necessary to achieve the IMMUNITY TEST LEVEL, the distance between the transmitting antenna
and the ME EQUIPMENT or ME SYSTEM may be reduced to 1 m. The 1 m test distance is permitted by IEC
61000-4-3.
NOTE: For some services, only the uplink frequencies are included.
NOTE: The carrier shall be modulated using a 50% duty cycle square wave signal.
Device Information 23
Residual Risks
Electric leakage causes electrical
shock.
The product uses a battery power
supply that will not cause electrical
shock due to leakage.
Acceptable
Incorrect cuff pressure results in
incorrect blood pressure values.
The user manual states that if you
have doubts about blood pressure,
you should inform your doctor.
Acceptable
Unable to automatically relieve
pressure, causing the user discom
fort.
The user manual states that if
you feel uncomfortable, you should
stop the measurement.
Acceptable
The product is damaged during the
delivery process and fails.
If the product is damaged due to
shipping, please contact the distrib
utor.
Acceptable
Causes adverse skin reactions.
All materials that come in contact
with human skin have passed the
biocompatibility test.
Acceptable
Electromagnetic fields interfere
with other product functions.
The products have passed EMC EN
60601-1-2 and IEC 301489-1/-17
verification tests.
Acceptable
The product function is affected by
the interference of environmental
electromagnetic fields.
The products have passed EMC EN
60601-1-2 and IEC 301489-1/-17
verification tests.
Acceptable
Generates an electromagnetic inter
ference that affects other nearby
products.
The products have passed EMC EN
60601-1-2 and IEC 301489-1/-17
verification tests.
Acceptable
Excessive pressure causes bruising
or redness.
The product has an over-pressure
protection mechanism. If you feel
unwell during the measurement,
please remove the cuff and stop
using the device.
Acceptable
Unable to automatically release
pressure, causing the user discom
fort.
The product has an over-pressure
protection mechanism. If you feel
unwell during the measurement,
please remove the cuff and stop
using the device.
Acceptable
Incorrect use that result in incorrect
blood pressure measurement.
The user manual explains the
correct way to use the device.
Acceptable
The blood pressure value measured
(on OLED) by the device displays
an incorrect error value, resulting in
false judgement.
The product has passed the
wireless interference test and
meets the requirements of EN 300
328 regulations.
Acceptable
Causes unstable blood pressure.
The user manual explains error
messages and precautions.
Acceptable
May cause injury or incorrect blood
pressure.
The user manual explains error
messages and precautions.
Acceptable
24 Device Information
EC Declaration of Conformity
according to the Medical Device Regulation (MDR) 2017/745
Declaration of Conformity
This declaration of conformity is issued under the sole responsibility of the manufacturer below mentioned.
The listed product is herewith confirmed to comply with the requirements set out in the Council Directive on
the harmonization of the Laws of the Member States concerning Regulation (EU) MDR 2017/745 for medical
devices (Annex IX – Conformity Assessment Based on a Quality Management System and Assessment of
Technical Documentation) certified by DNV Product Assurance AS (notified body number – 2460). The product
also complies with Council Directives 2011/65/EU (RoHS) and 2014/53/EU (RED).
For the following equipment:
Product Name: Index BPM
Model Designation / Brand Name: BP707 / Garmin
Manufacturer Name: Ya Horng Electronic Co., Ltd.
Factory: Ya Horng (Dongguan) Electronic Co., Ltd.
Manufacturer Address: No.35, Shalun, Anding Dist., Tainan City 745, Taiwan
Factory Address: Room 201, Building #9, No. 84 Gaoyu South Road, Tangxia Town, Dong Guan, Guangdong,
China
Single Registration Number (SRN): TW-MF-000010109
EU MDR certificate number issued and expiry:
Certificate No.: C539652
Initial Certification Date: 30 August 2023
Valid Until: 30 August 2028
Basic UDI-DI: 471987331BP2021A8G
Notified Body Name: DNV Product Assurance AS
Notified Body Number: CE 2460
Notified Body Address:
Veritasveien 1
1363 Høvik
Country: Norway
Intended Purpose: 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.).
Disclaimer: 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. The
Index BPM device is a standalone device and 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. The app does not
perform an action on data, or perform an action beyond storage.
GMDN Code: 45617 Automatic-inflation electronic sphygmomanometer, portable, arm/wrist
CND Code: Z1203020501 OSCILLOMETRIC NON INVASIVE BLOOD PRESSURE MONITORS
Classification: Class IIa MDR 2017/745 Annex VIII, Rule 10
Declared under the sole responsibility of the manufacturer mentioned above.
It is herewith confirmed to comply with the requirements set out in the Council Directive on the harmonization
of the Laws of the Member States concerning Regulation (EU) MDR 2017/745 for medical devices- Annex
IX CONFORMITY ASSESSMENT BASED ON A QUALITY MANAGEMENT SYSTEM AND ON ASSESSMENT OF
TECHNICAL DOCUMENTATION to be certified by DNV GL Presafe AS(notified body number - 2460). For the
evaluation regarding the Class IIa product safety aspects, the following harmonized standards are applied:
I, EU Harmonised Standards
Device Information 25
• EN ISO 13485:2016: Medical devices. Quality management systems. Requirements for regulatory purposes
• EN 60601-1:2006+A1:2013 : Medical electrical equipment - Part 1: General requirements for basic safety and
essential performance
• EN 1060-1: 1995 + A1: 2009 Non-invasive sphygmomanometers Part 1: General requirements
• EN 1060-3: 1997+A2:2009: Non-invasive sphygmomanometers. Supplementary requirements for electro-
mechanical blood pressure measuring systems
• EN ISO 81060-2:2019 Non-invasive sphygmomanometers — Part 2: Clinical investigation of intermittent
automated measurement type
• EN 60601-1-11: 2015: Medical electrical equipment -- Part 1-11: General requirements for basic safety and
essential performance -- Collateral standard: Requirements for medical electrical equipment and medical
electrical systems used in the home healthcare environment
• ETSI EN 300 328 v2.2.2: 2019: Electromagnetic compatibility and Radio spectrum Matters (ERM); Wideband
transmission systems; Data transmission equipment operating in the 2,4 GHz ISM band and using wide
band modulation techniques; Harmonized EN covering the essential requirements of article 3.2 of the Radio
Equipment Directive (2014/53/EU)
• ETSI EN 301 489 –1 v2.2.3: 2019 : Electromagnetic compatibility and Radio spectrum Matters (ERM);
ElectroMagnetic Compatibility (EMC) standard for radio equipment and services; Part 1: Common technical
requirements
• ETSI EN 301 489-17 v3.2.4 :2020 : Electromagnetic compatibility and Radio spectrum Matters (ERM);
ElectroMagnetic Compatibility (EMC) standard for radio equipment; Part 17: Specific conditions for
Broadband Data Transmission Systems
• EN 60601-1-2:2015 : Medical electrical equipment - Part 1-2: General requirements for basic safety and
essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
• EN 60601-1-6:2010+A1 :2015 : Medical electrical equipment - Part 1-6: General requirements for basic safety
and essential performance - Collateral standard: Usability
• EN 62366-1:2015 : Medical devices - Application of usability engineering to medical devices
• EN 62304:2006+A1 :2015 : Medical device software – Software life cycle processes
• Directive 2011/65/EU of the European Parliament and of the Council of 8 June 2011 on the restriction
of the use of certain hazardous substances in electrical and electronic equipment. The Certificate of
Compliance includes Directive 2015/863 published in 2015 by the EU (often referred as RoHS 3) and Directive
2017/2102/EU published by the EU November 17, 2015
• Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006
concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH)
II, International Standards
• ISO 14971:2019: Medical devices -- Application of risk management to medical devices
• IEC 60601-1: 2005+A1:2012 Medical electrical equipment - Part 1: General requirements for basic safety and
essential performance
• ISO 81060-2:2018+A1:2020 Non-invasive sphygmomanometers — Part 2: Clinical investigation of intermittent
automated measurement type
• IEC 80601-2-30: 2018: Medical electrical equipment -- Part 2-30: Particular requirements for basic safety and
essential performance of automated non-invasive sphygmomanometers
• IEC 60601-1-11:2015 : Medical electrical equipment -- Part 1-11: General requirements for basic safety and
essential performance -- Collateral standard: Requirements for medical electrical equipment and medical
electrical systems used in the home healthcare environment
• IEC 60601-1-2:2014 : Medical electrical equipment - Part 1-2: General requirements for basic safety and
essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
• ISO 10993-1: 2018: Biological evaluation of medical devices -- Part 1: Evaluation and testing within a risk
management process
• ISO 10993-5: 2009 : Biological evaluation of medical devices -- Part 5: Tests for in vitro cytotoxicity
• ISO 10993-10: 2010 : Biological evaluation of medical devices. Tests for irritation and skin sensitization
26 Device Information
• IEC 60601-1-6:2010+A1: 2013 : Medical electrical equipment - Part 1-6: General requirements for basic safety
and essential performance - Collateral standard: Usability
• IEC 62366-1: 2015/COR:2016: Medical devices - Application of usability engineering to medical devices
• ISO 15223-1:2021 : Medical devices -- Symbols to be used with medical device labels, labeling and
information to be supplied -- Part 1: General requirements
• IEC 62304:2006+A1 :2015 : Medical device software – Software life cycle processes
III, EU Common Specifications (CS)
• No applicable CS regulations
The following manufacturer/importer or authorized representative is responsible for this declaration:
Kahl Handelsvertretung
Isarstr. 33 40699 Erkrath Germany
Person responsible for the manufacturer for making this declaration:
Jerry Hsu, General Manager
Ya Horng
Device Information 27
support.garmin.com
GUID-EA605CDE-EED7-4FD7-A41F-7907A02E4062 v4April 2025
