Aktiia Bracelet User manual

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P01_0020 - User Manual
Objectives
This document is the User Manual associated to aktiia.bracelet. It will be provided electronically
to the end-user through Aktiia website.
Revision History
Revision
Revision Date
Summary of Changes
1
N/A
Initial version
2 13.09.2019
Edited as a revision controlled document (prior release v1 was not yet
under revision control)
Inclusion of requirements from IEC 60601-1-2 for Emission and Immunity
Approval
Role
Name
Title
Date/Signature
Author Elisa Olivero Product Manager
Reviewer Nadège Siutryk Project Manager
Approval Valentin Chapuis Quality Manager
13.09.2019 - PO Valentin Chapuis
13.09.2019
13.09.2019

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AKTIIA Bracelet
User’s manual
v 2
AKTIIA Bracelet
Non-invasive optical blood pressure monitor
Supplied with a charging station and a USB cable
www.aktiia.com
0123
Aktiia SA, Pierre-à-Mazel 39, 2000 Neuchâtel, Switzerland
www.aktiia.com/ifu

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Table of Content
1. Intended Use and technological characteristic.......................................................................................................... 4
2. Contraindications............................................................................................................................................................ 4
3. Cautions............................................................................................................................................................................ 4
4. Package contents ............................................................................................................................................................ 5
5. Setup and first initialization procedures ..................................................................................................................... 5
6. Correct AKTIIA bracelet positioning ............................................................................................................................. 6
7. Correct AKTIIA Cuff positioning..................................................................................................................................... 6
8. Body Posture during the Initialization Procedure...................................................................................................... 7
9. Accessing your data ........................................................................................................................................................ 7
10. How to evaluate your Blood Pressure...................................................................................................................... 8
10.1. US and Canada.................................................................................................................................................... 8
10.2. Europe .................................................................................................................................................................. 9
11. Troubleshooting.......................................................................................................................................................... 9
12.Care and maintenance ............................................................................................................................................. 10
13. Warranty ..................................................................................................................................................................... 10
14. Specifications ............................................................................................................................................................ 10
15. EMC and RF statements............................................................................................................................................ 11
16. Electromagnetic Compatibility Information ......................................................................................................... 11
17. CE compliance ........................................................................................................................................................... 12
18. FCC statement ........................................................................................................................................................... 13
19. Disposal ...................................................................................................................................................................... 14
20. Safety Information .................................................................................................................................................... 14

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Introduction
AKTIIA bracelet is the smart way to track your systolic and diastolic Blood Pressure and Heart Rate over days and
nights without any effort. AKTIIA bracelet is designed to be discreet, with no lights or alarms bothering you during
your daily tasks. With its ease of use and accuracy, AKTIIA is the perfect solution to track your blood pressure 24/7.
AKTIIA offers a new way for monitoring your heart health that easily integrates into your life. Our device tracks
your Blood Pressure through unnoticeable measurements performed multiple times per day. All you need to do
is to wear the bracelet. You can access your data anytime by simply looking at the AKTIIA smartphone app.
www.aktiia.com/ifu
Please read carefully this User Manual to gain a complete understanding of the device’s
functions and safety-related information. In case you have any additional questions, you
encounter any issue, or you would like to suggest some improvements, please contact AK-
TIIA’s Customer Service at [e-mail] or visit our website at www.aktiia.com
1. Intended Use and technological characteristic
AKTIIA bracelet is intended for non-invasive intermittent blood-pressure (BP) monitoring in adult population.
AKTIIA bracelet is intended to be used 24/7 in everyday life conditions. However, AKTIIA bracelet will provide
blood pressure measurement only when the user is motionless.
AKTIIA Bracelet uses a PPG technology (Photoplethysmography) to acquire reflective optical data on your wrist,
using a green LED. The PPG data are then transferred through the AKTIIA App to a secured cloud server on which
a PWA (Pulse Wave Analysis) algorithm estimate your blood pressure from the optical data.
2. Contraindications
AKTIIA Bracelet IS NOT INTENDED to be used in case of tachycardia (heart rate at rest > 120bpm), atrial
fibrillation, diabetes, renal dysfunctions (eGFR < 60mL/min/1.73 m2), hyper-/hypothyroidism, pheo-
chromocytoma, pregnancy, arteriovenous fistula.
AKTIIA Bracelet should not be applied on damaged / injured skin.
AKTIIA Bracelet is not intended for users below 21 y.o. and above 65 y.o.
3. Cautions
AKTIIA monitor is not intended to be a diagnostic device. Self-diagnosis of measurement results and
self-treatment are potentially dangerous. You should always consult your doctor for relevant interpre-
tation of blood pressure results.
This device may only be used for the purposes described in this User Manual. Aktiia cannot be held
liable for damage or injury caused by incorrect use. Always follow the operating procedures described
in this User Manual to measure your blood pressure accurately and safely.
AKTIIA bracelet is designed as a device for personal use (single user) only. Do not share your device
with others as it may result in inaccurate blood pressure readings.

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Your AKTTIA Bracelet Pod is small enough to be swallowed by a young child. To prevent risk of suffo-
cation, never leave your Pod unattended !
4. Package contents
Your AKTTIA Bracelet is supplied in a box containing the following items :
1 AKTIIA Bracelet
with Pod and Strap
1 Charging station
1 USB cable
+
1 Quick start guide
www. aktiia.com/ifu
AKTIIA bracelet requires a dedicated AKTIIA Cuff for initialization. AKTIIA Cuff is separately supplied.
Please read carefully the user manual of AKTIIA Cuff before performing any cuff-related action
recommended in this manual. In case of question about the supply of AKTIIA cuff, contact AKTIIA’s
Customer Service at [e-mail].
5. Setup and first initialization procedures
1. Charge Bracelet before First Use.
Connect your charging station to a USB port using the charging cable provided and place AKTIIA bracelet
on the station. A red light at the bottom of the charger will start blinking. When charge is completed, the
red-light indicator stops blinking.
2. Download the free AKTIIA App.
Go on the Google Play Store or Apple App Store, download and install the AKTIIA App.
3. Create a user account on Aktiia App.
Open the AKTIIA App on your mobile device and follow the instructions to register and set up your per-
sonal account.
4. Pair your AKTIIA bracelet with your mobile device.
Place AKTIIA bracelet on the charging station and switch on Bluetooth on your mobile device. For Android
devices, also enable location services. Wait until pairing is confirmed by AKTIIA App.
5. Pair your Aktiia Cuff with your mobile or tablet device.
Switch ON the AKTIIA cuff (separately supplied, please read the user manual of the cuff to know how to
Pod
Strap

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switch it on). Wait until pairing is confirmed by AKTIIA App.
6. Fit your Aktiia Bracelet on your wrist.
For optimal measurement by AKTIIA bracelet, please read carefully the instructions in the sec-
tion “Correct AKTIIA Bracelet positioning” of this user manual.
7. Fit your Aktiia Cuff on the opposite arm.
The accuracy of blood pressure measurement done by AKTIIA cuff depends on the right cuff
positioning. Please read carefully the instructions in the section “Correct AKTIIA Cuff position-
ing” of this user manual.
8. Initialize your AKTIIA Bracelet.
On the Aktiia App, follow carefully the instructions on the screen to start the initialization procedure. The
cuff will start inflating.
The accuracy of the initialization process depends on your body posture during the initializa-
tion. Read carefully the section “Body Posture during Initialization Procedure” of this user man-
ual.
9. Switch OFF your Aktiia Cuff.
Congratulations! Your AKTIIA bracelet is now initialized and ready to track your blood pressure!
6. Correct AKTIIA bracelet positioning
Wear your Aktiia Bracelet on the elbow side of your wrist bone. The sensing side of the pod should be placed in
direct contact with the skin, on the top part of the wrist. The Bracelet should be snug but comfortable.
Figure 1 : Correct positioning of AKTIIA Bracelet on the wrist
7. Correct AKTIIA Cuff positioning
Aktiia Cuff must be placed on the opposite arm with respect to the one wearing the Bracelet (i.e if you wear Aktiia
Bracelet on your RIGHT wrist, place the cuff over your LEFT arm and vice versa).
Please check the instructions for use provided with the companion device Aktiia Cuff (provided sep-
arately).
•Remove all accessories (watch, etc) from your arm.
•Roll or push up your sleeve to expose the skin.
•Apply the cuff to your arm with your palm facing up (opposite arm as the one on which you weaar AKTIIA
Bracelet).
•Position the edge of the cuff about 2cm~3cm from elbow.
•Fasten the cuff around your arm, leaving no extra room between the cuff and your skin. If the cuff is too loose,
the measurement will not be accurate.

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8. Body Posture during the Initialization Procedure
Please sit down and relax for 3 minutes before starting the initialization procedure.
1. Be seated with your feet flat on the floor without crossing your legs.
2. Place your hand palm-side up in front of you on a flat surface such as a desk or a table.
3. The middle of the cuff should be placed as the same level as your heart.
4. Do not move or tense your arm muscles during measurement.
5. Relax and do not talk.
9. Accessing your data
Your AKTIIA Bracelet automatically tracks your blood pressure. Measurements are triggered every hour, day and
night. To ensure optimal data security, your data are not stored on AKTIIA bracelet but on a secured cloud server.
Visualizing your data in AKTIIA App therefore requires a synchronization process with our server.
Syncing your data
Make sure Bluetooth and Internet connection on your mobile device are enabled. If you have an Android device,
your location service should be enabled as well. Otherwise warning messages will be shown on top of the home
screen when you open it (see Figure 1).
Open the Aktiia App to synchronize data from your Aktiia Bracelet. The synchronization is done automatically and
a sync view at the top of the screen shows you the sync status (see Figure 2). This might take few seconds to
several minutes depending on how often you open the app and synchronize your data.
In case you do not see a sync view when opening the app, swipe down to manually activate the synchronization.
Make sure you open the app regularly (i.e. once a day) so that the synchronization is fast, and you avoid losing
data.
Visualizing your Blood Pressure data
Press the Home button on the Aktiia App to see your blood pressure data in a chart format. Every vertical line
represents the average of the measurements taken during the displayed period (the top of the line is the systolic
SYS value and the bottom of the line is the diastolic DIA value). Tap on the line to read the numeric values. The
average Blood Pressure values for the day are indicated at the top of the screen. Tap left and right arrows to
navigate through your historical data.

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Figure 2
Figure 3
10.How to evaluate your Blood Pressure
AKTIIA monitor is not intended to be a diagnostic device. Self-diagnosis of measurement results and
self-treatment are potentially dangerous. You should always consult your doctor for relevant interpre-
tation of blood pressure results.
10.1. US and Canada
The American Heart Association (AHA) has created the following guide for classifying blood pressure values.
BLOOD PRESSURE CATEGORY
SYSTOLIC BP mmHg
DIASTOLIC BP mmHg
COLOR INDICATOR
NORMAL
LESS THAN 120
AND
LESS THAN 80
Green
ELEVATED
120-129
AND
LESS THAN 80
Yellow
HIGH BLOOD PRESSURE STAGE I
130-139
OR
80-89
Orange
HIGH BLOOD PRESSURE STAGE 2
140 OR HIGHER
OR
90 OR HIGHER
Light Red
HYPERTENSIVE CRISIS
HIGHER THAN 180
AND/OR
HIGHER THAN 120
Dark Red
This classification is based on measurements taken on a seated person after few minutes of rest. It is important
to note that Blood Pressure readings in normal life conditions might be higher.
This chart is not intended to provide a basis for any type of diagnosis or emergency assessment; this chart only
depicts different classifications of blood pressure. Consult your physician for an interpretation and diagnosis
based on your personal blood pressure results.
Note: Various factors such as age, obesity and medical condition should be considered for a correct evaluation.
Consult with your physicians for an accurate assessment and diagnosis of your health condition.
SYS
DIA

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10.2. Europe
The European Society of Hypertension (ESH) has created the following guide for classifying blood pressure values.
BLOOD PRESSURE CATEGORY
SYSTOLIC BP mmHg
DIASTOLIC BP mmHg
COLOR INDICATOR
OPTIMAL
LESS THAN 120
AND
LESS THAN 80
Dark Green
NORMAL
120-129
AND/OR
80-84
Light Green
ELEVATED
130-139
AND/OR
85-89
Yellow
HIGH BLOOD PRESSURE STAGE I
140-159
AND/OR
90-99
Orange
HIGH BLOOD PRESSURE STAGE 2
160-179
AND/OR
100-109
Light Red
HIGH BLOOD PRESSURE STAGE 3
HIGHER THAN 180
AND/OR
HIGHER THAN 110
Dark Red
This classification is based on measurements taken on a seated person after few minutes of rest. It is important
to note that Blood Pressure readings in normal life conditions might be higher.
This chart is not intended to provide a basis for any type of diagnosis or emergency assessment; this chart only
depicts different classifications of blood pressure. Consult your physician for an interpretation and diagnosis
based on your personal blood pressure results.
Note: Various factors such as age, obesity and medical condition should be considered for a correct evaluation.
Consult with your physicians for an accurate assessment and diagnosis of your health condition.
11.Troubleshooting
Situation
Resolution
I don’t know if my AK-
TIIA bracelet is ON.
To know if your AKTIIA bracelet is ON, double tap on the side
of the pod, a green light should blink within 5 seconds.
If the green light does not blink, your AKTIIA bracelet may be
out of power. Please put your device on the charging station.
A blinking red light indicates your device is charging. A con-
stant red light indicates your device battery is full.
My AKTIIA bracelet does
not charge.
Verify that the charging station is well connected to a power supply.
When placing AKTIIA Bracelet on the charging station a blinking red light indicates
your device is charging. A constant red light indicates your device battery is full. If
that is not the case, contact AKTIIA customer service.
My AKTIIA Bracelet does
not connect to my mo-
bile device.
Check that your mobile device Bluetooth is activated.
If your mobile device Bluetooth is activated but your AKTIIA Bracelet still does not
connect, place your AKTIIA Bracelet on the charging station to force a reset (you will
not lose your personal data or account information).
If the problem persists, contact AKTIIA customer service.

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12.Care and maintenance
AKTIIA Bracelet does not contain any part or component that requires maintenance operation by the user.
To avoid skin irritation, it is recommended to clean regularly your AKTIIA Bracelet. Simply wipe your AKTIIA Brace-
let with soft cloth lightly moistened with water. Then dry your AKTIIA Bracelet with a dry cloth.
AKTIIA Bracelet battery can maintain the performance characteristics for a minimum of 300 charge cycles.
Do not attempt to disassemble AKTIIA Bracelet as this will result in permanent damages and will void
your warranty.
If you encounter troubles with your AKTIIA Bracelet battery, please contact AKTIIA customer support.
13.Warranty
Your AKTIIA Bracelet is warranted to be free from defects in materials and workmanship within one year from the
date of purchase when used in accordance with the provided instructions. The warranty extends only to the end
user. We will, at our option, repair or replace without charge AKTIIA Bracelet covered by the warranty. Repair or
replacement is our only responsibility and your only remedy under the warranty.
14.Specifications
Product description
Non-invasive blood pressure monitor
Model
AKTIIA Bracelet
Measurement method
Photoplethysmography (PPG)
Measurement accuracy (Blood Pressure)
Accuracy ±3mmHg
Measurement range
Systolic: 60-260 mmHg
Diastolic: 40-199 mmHg
Classifications
Internally powered
Type B applied part (Pod)
IP33 (protected from spraying water and tools >2.5mm)
Power source
Li-Ion rechargeable battery 3.7 Vdc 55mAh
Communication module
BLE 5.0
Frequency range 2.4 to 2.4835 GHz
Modulation GFSK
Effective radiated power 0 dBm
Operating conditions
+5°C to 40°C
700hPa to 1060hPa
15 % to 90 % RH
Storage and transportation conditions
-20°C to +60°C
700hPa to 1060hPa
10% to 95% RH
AKTIIA Bracelet size
13 cm to 22 cm (diameter)
AKTIIA Bracelet weight
approximatively 18g.
Operating requirements
AKTIIA bracelet works with mobile devices operating Android 6.0 (or
higher) and with operational Bluetooth Low Energy (BLE) and Wi-fi or
3G/4G/5G connection.
In order to use AKTIIA bracelet you need to download the free AKTIIA app
from the Apple App Store or Google Play. Creation of a user account and
login are requested to operate AKTIIA bracelet.
AKTIIA Bracelet requires a companion device AKTIIA Cuff for initialization
and periodic re-initialization. AKTIIA Cuff is supplied separately.

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15.EMC and RF statements
AKTIIA bracelet needs special precautions regarding EMC and needs to be installed and put into service according
to the EMC information provided in the following section.
AKTIIA bracelet 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.
AKTIIA bracelet 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.
AKTIIA bracelet is intended for use in an electromagnetic environment in which radiated RF disturbances are con-
trolled. Interference may occur in the vicinity of equipment marked with the following symbol .
Portable and mobile RF communication equipment (e.g. cell phones) can affect AKTIIA bracelet.
WARNING: AKTIIA bracelet should not be used adjacent to or stacked with other equipment and if adjacent or
stacked use is necessary, it should be observed in order to verify normal operation in the configuration in which
it will be used.
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 AKTIIA bracelet, including cables speci-
fied by the manufacturer. Otherwise, degradation of the performance of this equipment could result.”
16.Electromagnetic Compatibility Information
Table 1 : Emission tests for all ME EQUIPMENT and ME SYSTEMS
Guidance and manufacture’s declaration - electromagnetic emissions
AKTIIA bracelet is intended for use in the electromagnetic environment specified below.
The user of AKTIIA bracelet should ensure that it is used in such an environment.
AKTIIA bracelet is suitable for use in “Home Healthcare Environment”, i.e. all establishments, including domes-
tic establishments and those directly connected to the public low-voltage power supply network that supplies
buildings used for domestic purposes.
Emission test
Compliance
Electromagnetic environment - guidance
Conducted emissions
CISPR11
Groupe 1AKTIIA bracelet 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.
Radiated emissions
CISPR11
Class B
Harmonic emissions IEC
61000-3-2
Not Applicable
-
Voltage fluctuations/Flicker
emissions IEC 61000-3-3
Not Applicable

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Table 2 : Immunity tests for all ME EQUIPMENT and ME SYSTEMS
Guidance and manufacturer’s declaration - electromagnetic immunity
AKTIIA bracelet is intended for use in the electromagnetic environment specified below.
The user of AKTIIA bracelet should ensure that it is used in such an environment.
AKTIIA bracelet is suitable for use in “Home Healthcare Environment”, i.e. all establishments, including domes-
tic establishments and those directly connected to the public low-voltage power supply network that supplies
buildings used for domestic purposes.
Immunity test
60601-1-2 test levels
Compliance
Electrostatic discharge
IEC 61000-4-2
± 8 kV contact
± 2 kV, ± 4 kV, ± 8 kV, ± 15 kV in air
± 8 kV contact
± 2 kV, ± 4 kV, ± 8 kV, ± 15 kV in air
Radiated RF electromagnetic field
IEC 61000-4-3
10 V/m
80 MHz à 2.4 GHz
80 % MA à 1 kHz
10 V/m
80 MHz à 2.4 GHz
80 % MA à 1 kHz
Proximity fields from RF wireless
communications equipment
IEC 61000-4-3 (interim method)
9 V/m
710 MHz, 745 MHz,
780 MHZ, 5240 MHz, 5550 MHz, 5785
MHz
27 V/m
385 MHz
28 V/m
450 MHz, 810 MHz,
870 MHz, 930 MHz,
1720 MHz, 1845 MHz, 1970 MHz,
2450 MHz
9 V/m
710 MHz, 745 MHz,
780 MHZ, 5240 MHz, 5550 MHz,
5785 MHz
27 V/m
385 MHz
28 V/m
450 MHz, 810 MHz,
870 MHz, 930 MHz,
1720 MHz, 1845 MHz, 1970 MHz,
2450 MHz
Power frequency magnetic field
IEC 61000-4-8
30 A/m
50 Hz
30 A/m
50 Hz
17.CE compliance
This device complies with the following regulations and normative documents/standards:
2017/745 (EU) Regulation of the European Parliament and of the Council of 5 April 2017 on medical devices, re-
pealing Council Directives 93/42/EEC
2014/53/EU Directive of the European Parliament and of the council of 16 April 2014 on the harmonization of the
laws of the Member States relating to the making available on the market of radio equipment
FCC part B 15B:2013 Electromagnetic Compatibility
FCC Rule Part: 15.247 Cat: DSS (Bluetooth)
EN ISO 10993-1:2009/AC:2010: Biological evaluation of medical devices -- Part 1: Evaluation and testing within a
risk management process
EN ISO 10993-5: 2009: Biological evaluation of medical devices -- Part 5: Tests for in vitro cytotoxicity

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EN ISO 10993-10: 2010: Biological evaluation of medical devices. Tests for irritation and skin sensitization
EN IEC 60601-1:2006/A1:2013: Medical electrical equipment – Part 1: General requirements for basic safety and
essential performance
EN IEC 60601-1-2:2015: Medical electrical equipment – Part 1-2: General requirements for basic safety and essen-
tial performance – Collateral Standard: Electromagnetic disturbances – Requirements and tests
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 sys-
tems used in the home healthcare environment
IEC 62471:2006: Photobiological safety of lamps and lamp systems
EN ETSI 301 489-1, V 2.1.1: ElectroMagnetic Compatibility (EMC) standard for radio equipment and services; Part
1: Common technical requirements
EN ETSI 301 489-17, V3.2.0: ElectroMagnetic Compatibility (EMC) standard for radio equipment and services; Part
17: Specific conditions for Broadband Data Transmission Systems
EN ETSI 300 328, V2.1.1: Wideband transmission systems; Data transmission equipment operating in the 2,4 GHz
ISM band and using wide band modulation techniques
18.FCC statement
FCC CAUTION
Changes or modifications not expressly approved by the party responsible for compliance could void the user’s
authority to operate the equipment. 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 (2) this device must accept
any interference received, including interference that may cause undesired operation.
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 in-
stalled 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 with the dealer or an experienced radio/TV technician for help.
This transmitter must not be co-located or operated in conjunction with any other antenna or transmitter.
This equipment complies with FCC radiation exposure limits set forth for an uncontrolled environment and meets
the FCC radio frequency (RF) Exposure Guidelines. This equipment has very low levels of RF energy that are
deemed to comply without testing of specific absorption ratio (SAR).

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19.Disposal
Actuation of European directives 2002/95/EC, 2002/96/EC and 2003/108/EC, for reduction in use of
dangerous substances in the electric and electronic device and for garbage 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 devices useful life, the user must deliver it to the able collecting centers for electric and electronic
garbage or give back to the retailer when purchasing a new device. Disposing of the product separately prevents
possible negative consequences for the environment and for health, deriving from inadequate disposal. It also
allows the recovery of materials of which it’s made up in order to obtain an important saving of energy and re-
sources and to avoid negative effects to the environment and health. In case of abusive disposal of device by the
user, will be applied administrative endorsements in compliance with current standard. The device and its parts
are made with regard to disposal, as appropriate, in accordance with national or regional regulations.
This product complies with RoHS Directive 2011/65/EU and Amendment (EU) 2015/863.
20.Safety Information
The signs below might be in the user manual, labeling or other component with your AKTIIA Bracelet.
www.aktiia.com/ifu
Symbol for “THE INSTRUCTION
FOR USE MUST BE READ”, with ref-
erence to the electronic version of
the instructions for use
Symbol for “CAUTION”, Indicates the
need for the user to consult the
instructions for use for important cau-
tionary information about user and/or
device safety.
0123
Symbol for “COMPLIES WITH
MDR EU2017/745 REQUIREMENTS”
Symbol for “ENVIRONMENT PROTEC-
TION - Electrical waste products should
not be disposed of
with household
waste. Please recycle where facilities
exist. Check with your local authority or
retailer for recycling advice”
Symbol for “MANUFACTURER”
Symbol for “THIS EQUIPMENT IS A
MEDICAL DEVICE”.
Symbol for “MANUFACTURE DATE”
Symbol for “UNIQUE DEVICE IDENTI-
FIER”
Symbol for “SERIAL NUMBER”
Symbol for “SINGLE PATIENT - MULTI-
PLE USE”