Aktiia INIT I1 User manual

User Manual
Blood Pressure Monitor AKTIIA INIT I1
Please read the user manual carefully and thoroughly to ensure the safe usage of this product. Keep the manual for your further reference in case
you have problems.
Thank you very much for selecting AKTIIA Blood Pressure Monitor AKTIIA INIT I1.
Arm Type

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Table of Contents
INTRODUCTION
General Description
Indications for Use
Contraindications
Measurement Principle
Safety Information
Symbols meaning
Monitor Components
List
BEFORE YOU START
Power Supply and Charging
Tie the cuff
MEASUREMENT
Start Measurement
INFORMATION FOR USER
Tips for Measurement
Maintenance
Component list of pressure measuring system

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ABOUT BLOOD PRESSURE
What are systolic pressure and diastolic pressure?
What is the standard blood pressure classification?
Why does my blood pressure fluctuate throughout the day?
Why do I get a different blood pressure at home compared to the hospital?
Is the result the same if measuring on the right arm?
SPECIFICATIONS
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FCC STATEMENT
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COMPLIED EUROPEAN STANDARDS LIST
EMC GUDIANCE
What you need to pay attention to when you measure your blood pressure at home?

INTRODUCTION
General Description
Thank you for selecting AKTIIA arm type blood pressure monitor (AKTIIA INIT I1). The monitor features blood pressure measurement, pulse
rate measurement and the result storage. The design provides you with two years of reliable service.
Readings taken by this mornitor are equivalent to those obtained by a trained observer using the cuff and stethoscope auscultation method.
This manual contains important safety and care information, and provides step by step instructions for using the product.
Please read the manual thoroughly before using the product
Indications for Use
The AKTIIA Blood Pressure Monitor is a digital monitor intended for use in measuring blood pressure and and heart rate in adults with arm
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Contraindications
1.The device should not be used by any person who may be suspected of, or is pregnant .
2.The device is not suitable for use on patients with implanted, electrical devices, such as cardiac pacemakers, defibrillators.
Measurement Principle
This product uses the Oscillometric Measuring method to detect blood pressure. Before every measurement, the unit establishes a “zero
pressure” equivalent to the atmospheric pressure. Then it starts inflating the arm cuff, meanwhile, the unit detects pressure oscillations generated
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Safety Information
The signs below might be in the user manual, labeling or other component. They are the requirement of standard and using.
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Symbol for “ENVIRONMENT
PROTECTION - 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 “Authorised Representative
in the European Community
EC REP
SN
Symbol for “TYPE BF APPLIED
PARTS”
Symbol for “THE OPERATION
GUIDE MUST BE READ”
Symbol for “COMPLIES WITH
MDD 93/42/EEC REQUIREMENTS”
Symbol for “MANUFACTURER”
Symbol for “SERIAL NUMBER”
Symbol for “DIRECT CURRENT”
Symbol for “MANUFACTURE
DATE”
Caution: These notes must be
observed to prevent any damage
to the device.
Symbol for “RECYCLE”
The Green Dot is the license symbol
of a European network of
industry-funded systems for recycling
the packaging materials of consumer
goods.

CAUTION
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* This device is intended for adult use in homes only.
* The device is not suitable for use on neonatal patients, pregnant women,patients with implanted, electronical devices, patients with pre-eclampsia, premature ventricular beats,
atrial fibrillation, peripheral, arterial disease and patients undergoing intravascular therapy or arterio-venous shunt or people who received a mastectomy. Please consult your doctor
prior to using the unit if you suffer from illnesses.
* The device is not suitable for measuring the blood pressure of children. Ask your doctor before using it on older children.
* The device is not intended for public use.
* This device is intended for non-invasive measuring and monitoring of arterial blood pressure.
It is not intended for use on extremities other than the arm or for functions other than obtaining a blood pressure measurement.
* Do not confuse self-monitoring with self-diagnosis. This unit allows you to monitor your blood pressure.Do not begin or end medical treatment without asking a physician for
treatment advice.
* If you are taking medication,consult your physician to determine the most appropriate time to measure your blood pressure. Never change a prescribed medication without
consulting your physician.
* Do not take any therapeutic measures on the basis of a self measurement. Never alter the dose of a medicine prescribed by a doctor. Consult your doctor if you have any question
about your blood pressure.
* When the device is used to measure patients who have common arrhythmias such as atrial or ventricular premature beats or atrial fibrillation, the results might be inaccurate.
Please consult your physician about the result.
* When using this device, please pay attention to the following situation which may interrupt blood flow and influence blood circulation of the patient, thus cause harmful injury to the
patient: consecutive multiple measurements; the application of the cuff and its pressurization on any arm where intravascular access or therapy, or an arterio-venous (A-V) shunt, is
present; inflating the cuff on the side of a mastectomy.
* Warning: Do not apply the cuff over a wound;otherwise it can cause further injury.
*Do not inflate the cuff on the same limb which other monitoring ME equipment is applied around simultaneously, because this could cause temporary loss of function of those
simultaneously-used monitoring ME equipment.
*On the rare occasion of a fault causing the cuff to remain fully inflated during measurement, open the cuff immediately. Prolonged high pressure (cuff pressure ＞300mmHg or
constant pressure ＞15mmHg for more than 3 minutes) applied to the arm may lead to an ecchymosis.
*Please check that operation of the device does not result in prolonged impairment of patient blood circulation.
* When measuring, please avoid compression or restriction of the connection tubing.
* The device cannot be used with HF surgical equipment at the same time.

CAUTION
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* The ACCOMPANYING DOCUMENT shall disclose that the SPHYGMOMANOMETER is clinically investigated according to the requirements of ISO 81060-2:2013.
* To verify the calibration of the AUTOMATED SPHYGMOMANOMETER, please contact the manufacturer.
* This device is contraindicated for any female who may be suspected of, or is pregnant. Besides providing inaccurate readings, the effects of this device on the fetus are unknown.
* Too frequent and consecutive measurements could cause disturbances in blood circulation and injuries.
* This unit is not suitable for continuous monitoring during medical emergencies or operations.Otherwise, the patient’s arm and fingers will become anaesthetic, swollen and even
purple due to a lack of blood.
* When not in use, store the device with the adapter in a dry room and protect it against extreme moisture, heat, lint, dust and direct sunlight. Never place any heavy objects on the
storage case.
* This device may be used only for the purpose described in this booklet. The manufacturer cannot be held liable for damage caused by incorrect application.
*This device comprises sensitive components and must be treated with caution. Observe the storage and operating conditions described in this booklet.
* The maximum temperature that the applied part can be achieved is 42.5℃while the environmental temperature is 40℃.
* The equipment is not AP/APG equipment and not suitable for use in the presence of a flammable anesthetic mixture with air of with oxygen or nitrous oxide.
* Warning: No servicing/maintenance while the ME equipment is in use.
* The patient is an intended operator.
* The patient can measure data and charge power under normal circumstances and maintain the device and its accessories according to the user manual.
* To avoid measurement errors, please avoid the condition of strong electromagnetic field radiated interference signal or electrical fast transient/burst signal.
* The blood pressure monitor, its adaptor, and the cuff are suitable for use within the patient environment. If you are allergic to polyester, nylon or plastic, please don't use this device.
* During use, the patient will be in contact with the cuff. The materials of the cuff have been tested and found to comply with requirements of ISO 10993-5:2009 and ISO
10993-10:2010. It will not cause any potential sensization or irritation reaction.
* Adaptor is specified as a part of ME EQUIPMENT.
* If you experience discomfort during a measurement, such as pain in the arm or other complaints, press the START/STOP button to release the air immediately from the cuff. Loosen
the cuff and remove it from your arm.
* When the cuff pressure reaches 40 kPa (300 mmHg), the unit will automatically deflate. If the cuff not deflate when pressure reaches 40 kPa (300 mmHg), detach the cuff from the
arm and press the START/STOP button to stop inflation.
* Before use, make sure the device functions safely and is in proper working condition. Check the device, do not use the device if it is damaged in any way. The continuous use of a
damaged unit may cause injury, improper results, or serious danger.

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CAUTION
* Do not wash the cuff in a washing machine or dishwasher!
* The service life of the cuff may vary by the frequency of washing, skin condition, and storage state. The typical service life is 10000 times.
* It is recommended that the performance should be checked every 2 years and after maintenance and repair, by retesting at least the requirements in limits of the error of the cuff
pressure indication and air leakage (testing at least at 50mmHg and 200mmHg).
* Please dispose of ACCESSORIES, detachable parts, and the ME EQUIPMENT according to the local guidelines.
* Manufacturer will make available on request circuit diagrams, component part lists, descriptions, calibration instructions,etc., to assist to service personnel in parts repair.
* The plug/adapter plug pins insulates the device from the main supply. Do not position the device in a position where it is difficult to disconnect from the supply mains to safely
terminate operation of ME equipment.
* The operator shall not touch output of batteries /adapter and the patient simultaneously.
* Cleaning: Dust environment may affect the performance of the unit. Please use the soft cloth to clean the whole unit before and after use. Don’t use any abrasive or volatile
cleaners.
* The device doesn’t need to be calibrated within two years of reliable service.
* If you have any problems with this device, such as setting up, maintaining or using, please contact the SERVICE PERSONNEL of AKTIIA. Don’t open or repair the device by
yourself in the event of malfunctions. The device must only be serviced, repaired and opened by individuals at authorized sales/service centers.
* Please report to AKTIIA if any unexpected operation or events occur.
* Keep the unit out of reach of infants, young children or pets to avoid inhalation or swallowing of small parts. It is dangerous or even fatal.
* Be careful to strangulation due to cables, particularly due to excessive length.
* At least 30 min required for ME equipment to warm from the minimum storage temperature between uses until it is ready for intended use. At least 30 min required for ME
equipment to cool from the maximum storage temperature between uses until it is ready for intended use.
* This equipment needs to be installed and put into service in accordance with the information provided in the ACCOMPANYING DOCUMENTS;
* Wireless communications equipment such as wireless home network devices, mobile phones, cordless telephones and their base stations, walkie-talkies can affect this equipment
and should be kept at least a distance d away from the equipment. The distance d is calculated by the MANUFACTURER from the 80 MHz to 5.8 GHz column of Table 4 and Table 9
of IEC 60601-1-2:2014, as appropriate.
* Please use ACCESSORIES and detachable parts specified/ authorised by MANUFACTURER. Otherwise, it may cause damage to the unit or danger to the user/patients.
* There is no luer lock connectors are used in the construction of tubing.If there has, there is a possibility that they might be inadvertently connected to intravascular fluid systems,
allowing air to be pumped into a blood vessel.
* Please use the device under the environment which is provided in the user manual. Otherwise, the performance and lifetime of the device will be impacted and reduced.

Symbols meaning
Systolic
Blood Pressure High blood pressure
Diastolic
Blood Pressure Low blood pressure
Blood pressure monitor is detecting a
heartbeat during measurement.
Heart rate
The average value of arterial blood
pressure during a cardiac cycle
Systolic
Diastolic
Mean Mean arterial
pressure
HR
8
mmHg
mmHg
mmHg

Monitor Components
LIGHT
THE DEVICE
ON/OFF BUTTON
USB CONNECTOR PORT
Component list of pressure measuring system
1 PCBA
2 Air pipe
3 Pump
5 Cuff
4 Valve
List
1.Blood Pressure Monitor
(AKTIIA INIT I1)
2.USB Cable
3.User Manual
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4. Cuff (22cm-42cm) (Type BF Applied Part)(Please use AKTIIA authorized cuff.
For the size of the actual cuff, please refer to the label on the attached cuff.
CUFF
(Type BF
applied part)
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USB A connector USB A connector
USB cable
USB microB connector
USB 2.0 or USB 3.0 for computers
conforming to IEC60601-1
Device
AC adapter (Not included)
(Model: BLJ06L050100U-V)
USB cable USB cable
If connecting to the AC adapter, justIf connecting to a computer, just
like the following picture: like the following picture:
USB connector port
AC adaptor
Charging the power under following circumstances:
When the red light is flashing, the battery power is lower.
Note: Charge at least once every three months. If the battery
loses all its charge, it may not be rechargeable.
When powering on the monitor, the light doesn’t light up.
Power Supply and Charging
1. The battery of AKTIIA INIT I1 is built-in rechargeable li-polymer
battery, the battery current is 1000 mAh.
2. If charging for the  time (immediately after purchase or after not
having used it for a long time), or if the battery stops working while
using the device, make sure to charge it fully.
1. Connect the USB microB connector of the USB cable to the
device's USB connector port.
2. Connect the USB A connector of the USB cable to the USB
ports noted below.
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BEFORE YOU START

* The battery of AKTIIA INIT I1 is built-in rechargeable lithium-ion battery, please do not disassemble it by the unauthorized maintenance personel.
* Under normal usage, it can charge power about 300 times, if the battery cannot charge the power normally or the blood pressure monitor cannot be used normally,
please connect with the authorized maintenance personel.If measured three times per day, and the battery is fully charged, it can be used for about 23 days.
* Store and use the blood pressure monitor in a cool, dry and ventilated environment. Avoid to approach to fire and heat sources or the battery may explode.
* Only AKTIIA's authorized AC Adaptor can be used ( Model: BLJ06L050100U-V) (Not included) to charge the power. You cannot use the blood pressure monitor
during the process of charging.
* During the process of charging, the light turns green, it means the charging is finished, please pull the plug.
* When charging, shall not touch charging connector and the patient simultaneously.
* Do not attempt to replace your blood pressure monitor’s battery. It is built-in and not changeable.
* Only charge the battery in accordance with the user instructions supplied with the blood pressure monitor.
* Avoid charging your blood pressure monitor in extremely high or low temperatures.
* Do not use your blood pressure monitor while you are charging it.
* Do not attempt to disassemble the blood pressure monitor or force open the built-in battery.
* Do not clean the blood pressure monitor when it is being charged. Always unplug the charger first before cleaning the blood pressure monitor.
* Do not dispose of your blood pressure monitor in a fire. The battery could explode causing injury or death.
* Batteries (battery pack or batteries installed) shall not be exposed to excessive heat such as sunshine, fire or the like.
Charge at least once every three months. If the battery loses all its charge, it may not be rechargeable.
PROBLEM SYMPTOM CHECK THIS REMEDY
No power
Low
Measurement error
batteries
The light is not on.
The battery is empty Recharge the battery.
The battery is low.
The button is in the “OFF” side. Switch the button on the “ON” side.
Red light flashing. Recharge the battery.
APP displays "Recording failed".
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Cuff not tight or inflated properly, talk or walk while
measuring and the measurement is out of range.
Adjust the cuff, hold still, and
measure again.

Tie the Cuff
1. Remove all accessories (watch, bracelet,etc) from your arm. If your physician has diagnosed you with poor circulation in your arm, use the other
one.
2. Roll or push up your sleeve to expose the skin.
3. Apply the cuff to your arm with your palm facing up.
4. Position the edge of the cuff about 2cm~3cm from elbow.
5. 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.
6. Sit comfortably with your tested arm resting on a flat surface. Place your elbow on a table so that the cuff is at the same level as your heart.
Turn your palm upwards. Sit upright in a chair, and take 5-6 deep breaths.
7. Helpful tips for Patients, especially for Patients with Hypertension:
Rest for 5 minutes before first measuring.
Wait at least 3 minutes between measurements. This allows your blood circulation to recover.
Take the measurement in a silent room.
The patient must relax as much as possible and not move and talk during the measurement procedure.
The cuff should be maintained at the same level as the right atrium of the heart.
Please sit comfortably. Do not cross your legs and keep your feet flat on the ground.
Keep your back against the backrest of the chair.
For a meaningful comparison, try to measure under similar conditions. For example, take daily measurements at approximately the same time,
on the same arm, or as directed by a physician.Take the measurement in a silent room.
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MEASUREMENT
Start the Measurement
Before you start the measurement, Download the Aktiia Cuff app from APP Store or Google Play, and turn on the Bluetooth. Install the APP, and register an account.
Then set your personal information (Gender, Birthday, Height, Weight, Name and so on).
1.Switch the button to the “ON” side to turn on the monitor,and the blue light will blink.
Note: If the button is on the “OFF” side, there is no reaction when you press any button.
2. Open Aktiia cuff app on your mobile device.
3. Press on “START PAIRING” to launch the pairing procedure.
4. Once the pairing is done, the battery level information will be displayed in the screen.
5. Press on “START INITIALIZATION” to launch the measurement.
6. In case of recording stop or failure during the measurement, press on “TRY AGAIN”.
7. If the recording failed, the possible reasons of failures might be:
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


In this case, check your connection and try to reconnect to the Aktiia cuff. During the measurement, you should sit or stay still
and not move.
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Tips for Measurement
Measurements may be inaccurate if taken in the following circumstances.
Maintenance
To obtain the best performance, please follow instructions below.
Put in a dry place and avoid the sunshine.
Avoid intense shaking and collisions.
Use the slightly damp cloth to remove the dirt.
Avoid immersing it in the water,Clean it with a dry cloth in case.
Avoid dusty environment and unstable temperature surrounding.
Avoid washing the cuff.
Within 1 hour after
dinner or drinking
Immediate measurement
after tea, coffee, smoking
Within 20 minutes
after taking a bath
When talking or moving
your fingers
In a very cold environment When you want to
discharge urine
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INFORMATION FOR USER

What are systolic pressure and diastolic pressure?
When ventricles contract and pump blood out of the heart, the blood pressure reaches its
maximum value in the cycle, which is called systolic pressure. When the ventricles relax,
the blood pressure reaches its minimum value in the cycle, which is called diastolic pressure.
1. 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 interpretation of blood pressure results.
The following classifications are 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.
These charts are not intended to provide a basis for any type of diagnosis or emergency assessment; these charts only depict different
classifications of blood pressure. Consult your physician for an interpretation and diagnosis based on your personal blood pressure results.
press
artery vein
blood discharging
Systolic
relax
blood entering
Diastolic
Contact a physician if your blood pressure value has
reached a dangerous point
CAUTION
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ABOUT BLOOD PRESSURE
BLOOD PRESSURE CATEGORY SYSTOLIC BP mmHg DIASTOLIC BP mmHg COLOR INDICATOR
NORMAL LESS THAN 120 AND LESS THAN 80 Dark Green
ELEVATED 120-129 AND/OR LESS THAN 80 Yellow
HIGH BLOOD PRESSURE STAGE I 130-139 AND/OR 80-89 Orange
HIGH BLOOD PRESSURE STAGE 2 140 OR HIGHER AND/OR 90 OR HIGHER Light Red
HYPERTENSIVE CRISIS HIGHER THAN 180 AND/OR HIGHER THAN 120 Dark Red
1.1 United States of America
The American Heart Association
(AHA) has created the following
guide for classifying blood
pressure values.

Why does my blood pressure fluctuate throughout the day?
1. Individual blood pressure varies multiple times everyday. It is also affected by the way
you tie your cuff and your measurement position, so please take the measurement under
the same conditions.
2.If the person takes medicine, the pressure will vary more.
3.Wait at least 3 minutes for another measurement.
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BLOOD PR ESSURE CATEGORY SYSTOLIC BP mm Hg DIASTOLIC BP m mHg COLOR INDICATOR
OPTIMAL LESS THAN 120 AND LESS THAN 80 Dark Green
Light GreenNORMAL 120-129 AND/OR 80-84
YellowELEVATED 130-139 AND/OR 85-89
Orange
HIGH BLOOD PRESSURE STAGE I 140-159 AND/OR 90-99
Light Red
HIGH BLOOD PRESSURE STAGE 2
HIGH BLOOD PRESSURE STAGE 3
160-179
HIGHER THAN 180
AND/OR
AND/OR
100-109
HIGHER THAN 110 Dark Red
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.
1.2 Europe
The European Society of
Hypertension (ESH) has
created the following guide
for classifying blood
pressure values.

Why do I get a different blood pressure at home compared to the hospital?
The blood pressure is different even throughout the day due to weather, emotion, exercise, etc. Also, there is the “white coat”effect, which means
blood pressure usually increases in clinical settings.
What you need to pay attention to when you measure your blood pressure at home?
If the cuff is too tight or too loose.
If the cuff is tied properly.
If the cuff is tied on the upper arm.
If you feel anxious.
Taking 2-3 deep breaths before beginning will be better for measuring.
Advice: Relax yourself for 4-5 minutes until you calm down.
Is the result the same if measuring on the right arm?
It is ok for both arms, but there will be some different results for different people.
We suggest you measure the same arm every time.
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