Aktiia Init i1 User manual

Init I1

EN– UserManual

2020-12-11技术要求：1、黏合不可露胶2、保持印刷面板上的清洁3、注意套印的准确性4、表面处理不可爆开5、结构工艺以结构受控图为准6、颜色参考：产品型号材质

尺寸

105G铜版纸

产品名称血压计TMB-1973-B李秋燕 2020-12-11罗佳钰 2020-12-11谭文昊 2020-12-11TMB-1973-B-GB-04PO#2B6808-TMB-1973-B-GB-04-说明书-A0

共 56 张第 1 张A/0对应结构图纸印色

1:1表面处理

1 – EN

Content

Introduction 2

Intended purpose 2

Indications for use 3

Contraindications 3

Technological characteristics 3

Important safety information 4

Package content 6

Power supply and charging 7

Correct Aktiia Init I1 positioning 8

Body posture during measurement 8

Start the measurement 9

Important facts about Blood Pressure measurement 10

How to evaluate your Blood Pressure 11

Some frequently asked questions 13

Unpair your device 14

Care and maintenance 14

Troubleshooting 15

Warranty 15

Specications 16

EMC and RF statements 18

Electromagnetic compatibility information 19

CE compliance 23

Disposal 24

Safety information 25

Network security recommendations 26

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1 Introduction

Thank you for selecting Aktiia arm type blood pressure monitor (Aktiia Init I1). The monitor features include blood pressure measurement

and pulse rate measurement. The monitor is designed for at least two years of reliable service.

Readings taken by the Aktiia Init I1 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.

Please read this User Manual carefully 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

Aktiia’s Customer Service at [email protected] or visit our website at www.aktiia.com

2 Intendedpurpose

Aktiia Init I1 is an oscillometric (cuff-based) blood pressure monitor intended to measure blood pressure and heart rate of a user.

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3 Indicationsforuse

Aktiia Init I1 is indicated to be used for measuring blood pressure and heart rate in adults with arm circumference ranging from 22cm to 42cm

(about 8¾˝-16½˝). Aktiia Init I1 is indicated for home use.

4 Contraindications

Aktiia Init I1 should not be used by any person who is pregnant or may possibly be pregnant.

Aktiia Init I1 is not suitable for use on patients with implanted electrical devices, such as cardiac pacemakers or debrillators.

Aktiia Init I1 is not suitable for use neonatal patients, children, patients with pre-eclampsia, premature ventricular beats, atrial brillation,

peripheral arterial disease, and patients undergoing intravascular therapy or arterio-venous shunt, or people who have received a mastectomy.

Please consult your doctor prior to using the device if you have one of these listed conditions.

5 Technologicalcharacteristics

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. With ination of the arm cuff, the unit detects pressure oscillations generated by the brachial artery pulsatility,

which are used to determine the systolic and diastolic pressure, as well as pulse rate.

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6 Importantsafetyinformation

Please read the important safety information in this user manual before using the device.

Any serious incident occurring in relation to Aktiia Init I1 should be reported to Aktiia and the competent authority of the Member State

in which the user and / or patient is established.

6. 1 Warnings

The“WARNING”signthroughoutthisusermanualindicatesapotentiallyhazardoussituationwhich,

ifnotavoided,couldresultinseriousinjuryordeath.

• Keep the device out of reach of young children to avoid swallowing of small parts.

• 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

• If you are taking medications, 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 apply the cuff over a wound, otherwise it can cause further injury.

6. 2 Cautions

The “Caution” sign throughout this user manual indicates a potentially hazardous situation which,

if not avoided, could result in minor injury to the user or patient or damage to the equipment or other property.

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• This device may be used only for the purpose described in this manual.

The manufacturer cannot be held liable for damage caused by

incorrect application.

• Do not inate the cuff on the same limb which other monitoring equipment

is applied simultaneously.

This could cause temporary loss of function of the monitoring equipment

that is being simultaneously used.

• On the rare occasion of a fault causing the cuff to remain fully inated

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.

• Check that operation of the device does not result in prolonged

impairment of the patient‘s blood circulation. Too frequent and

consecutive

measurements could cause disturbances in blood circulation and injuries.

• This device comprises sensitive components and must be treated with

caution. Observe the storage and operating conditions described in this

manual.

• Do not realize servicing / maintenance while the device is in use. It is

recommended that the performance should be checked every 2 years,

as well as after maintenance and repair. Contact the manufacturer for

such operation.

• If you are allergic to polyester, nylon or plastic, don‘t use this device.

• Check the device before use, do not use the device if it is damaged

in any way. The use of a damaged unit may cause injury or improper

results.

• The service life of the cuff may vary by the frequency of measurement

and cleaning and storage state. The typical service life is 10,000

measurements.

• Please dispose the device and associated accessories according to local

disposal guidelines.

• Dust 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.

• 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 use accessories and detachable parts specied / authorised by

the manufacturer. Otherwise, it may cause damage to the unit or danger

to the user.

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1xAktiiaInitI1 1xUSBcable 1xUserManual

Latest version of

Aktiia Init I1 user manual

can also be found online at :

www.aktiia.com/ifu

LIGHT

THE DEVICE

USB CONNECTOR PORT

ON/OFF BUTTON

7 Packagecontent

Your Aktiia Init I1 is supplied in a box containing the following items :

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8 Powersupplyandcharging

The battery of Aktiia Init I1 is a built-in rechargeable li-polymer

battery. The battery capacity is 1000 mAh.

If charging for the rst 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.

To charge your device :

1. Switchon your AKTIIA Init I1.

2. Connect the USB microB connector of the USB cable to the device‘s

USB connector port.

3. Connect the USB A connector of the USB cable to the USB ports noted below.

Charge the battery under following circumstances :

• When the red light is ashing, the battery power is low.

• When powering on the monitor, the light doesn’t light up

Note : Charge at least once every three months. If the battery completely loses all charge, it may not be rechargeable anymore.

Batteries shall not be exposed to excessive heat such as direct sunshine, re, or other similar situations.

The battery could explode causing injury or death.

Do not attempt to replace the device battery : it is built-in and not changeable. Only charge the battery in accordance with the user instructions

supplied with the device. Do not use the blood pressure monitor while charging. Do not clean the blood pressure monitor when it is being charged.

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

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9 CorrectAktiiaInitI1positioning

1. Remove garments from your upper arm. If you roll up your sleeve, please ensure that the garment is not

too tight so that it does not cause any blood ow constriction.

2. Place your bare arm through the cuff and position the cuff ~1“ (2~3 cm) above your elbow joint.

3. Tighten the cuff around your arm so that it ts closely but you can still insert two ngers between your arm

and the cuff. Secure the cuff closed with the Velcro fastener. Please note that if the cuff is too loose, the

measurement will not be accurate.

4. While seated, place your hand, palm side-up in front of you so that it is supported by a at surface and the

Aktiia Init I1 is at the same height as your heart. Your Aktiia Init I1 is positioned on the inner side of your arm,

over the artery and the logo is at its top.

10 Bodypostureduringmeasurement

Please sit down and relax for 5 minutes before starting the initialization procedure.

1. Sit upright with your back straight and your feet at on the oor. Do not cross your legs.

2. Place your hand palm-side up in front of you on a at surface such as a desk or a table.

3. The middle of the Aktiia Init I1 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.

Note: Blood Pressure measurements can be affected by the position of the cuff and your physiological and emotional condition.

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11 Startthemeasurement

1. DownloadthefreeAktiiaApp.

Scan the QR code below or go to the Google Play store or Apple App Store, then download and install the Aktiia App.

2. CreateauseraccountonAktiiaApp(orlogintoyourexistinguseraccount).

Open the Aktiia App on your mobile device and follow the instructions to register and set up your personal account.

3. SwitchonAktiiaInitI1.

Switch ON Aktiia Init I1 by acting on the ON / OFF toggle button. A blue light should start blinking.

4. PairyourAktiiaInitI1withyourmobiledevice.

Press the “START PAIRING” button on your Aktiia app to start the pairing procedure.

Wait until pairing is conrmed by Aktiia App and the light indicator is a steady blue.

5. FityourAktiiaInitI1onyourarmandprepareformeasurement.

Follow the procedure described in §7 and §8.

6. Presson“STARTINITIALIZATION”tostartthemeasurement.

Follow the instructions on screen

7. SwitchOFFandstoreyourAktiiaCuff.

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press

artery vein

blood discharging

Systolic

relax

blood entering

Diastolic

12 ImportantfactsaboutBloodPressuremeasurement

Blood pressure is the pressure applied by circulating blood on the walls of blood vessels. Blood pressure is

mainly due to the work of the heart pumping blood through the circulatory system. When the ventricles contract

and pump blood out of the heart, the blood pressure reaches its maximum value in the cardiac 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.

Individual blood pressure naturally varies through regular daily life. Some circumstances have a larger

impact on your blood pressure variation and may bias the measurement.

Measurements may be inaccurate if taken

in the following circumstances :

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 ngers

In a very cold environment When you want to

discharge urine

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13 HowtoevaluateyourBloodPressure

Aktiia Init I1 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 and diagnosis based on your personal blood pressure results.

The following classications 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 classications of blood pressure.

13. 1 UnitedStatesofAmerica

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

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

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14 Somefrequentlyaskedquestions

Whydoesmybloodpressuremeasurementsdifferthroughouttheday?

Individual blood pressure naturally varies through regular daily life (see §10). It is also affected by the way you tie your cuff and your measurement position,

so please try take the measurements under the same conditions. If you are under prescription drugs, your blood pressure may vary more.

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 a phenomenon known as

“white coat“ effect; evidence shows that blood pressure usually increases in clinical settings, due to stress, anxiety, or other causes.

Whatyouneedtopayattentiontowhenyoumeasureyourbloodpressureathome?

• The cuff is tied properly.

• The cuff is not too tight or too loose.

• The cuff is tied on the upper arm.

• You are relaxed. Waiting for 5 minutes and taking deep breaths before beginning will yield a more accurate measurement.

Istheresultthesameifmeasuringontherightarm?

• It is ok to measure on either arm, but the results may vary for different people.

• We suggest you measure on the same arm every time.

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15 Unpairyourdevice

During the pairing procedure, the Aktiia Init I1 is linked to your Aktiia account. In case you wish

to reset the pairing and allow another person to use the device you must reset the pairing rst.

To complete the unpairing procedure you should :

1. Login to your account

2. Tap on the device tab

3. Tap on the button with the three dots

4. Press unpair

Note : Unpairing is needed if Aktiia Init I1 need to be linked with a new user account.

Note : Unpairing is not needed if a new mobile device is used with the same user account.

16 Careandmaintenance

To obtain the best performance, please follow the instructions below.

• Store in a dry place and avoid sunshine.

• Avoid intense shaking, or collisions.

• Use a slightly damp cloth to remove any dirt or dust.

• Avoid immersing in the water. Clean with a dry cloth if wet.

• Avoid dusty environments or uctuating temperatures.

• Avoid washing the device other than with a damp cloth (per above).

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18 Warranty

Your Aktiia Init I1 is warranted to be free from defects in materials and workmanship within two years 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 Init I1 covered by the

warranty. Repair or replacement is our only responsibility and your only remedy under the warranty.

Do not attempt to disassemble the device as this will result

in permanent damages and will void your warranty.

17 Troubleshooting

Problem Symptom Checkthis Solution

No power The status LED is not on

The battery is empty Recharge the device

The side button is on the OFF position Switch the button to the ON position

Low battery Status LED ashing red Battery is low Recharge the device

Measurement error The mobile application displays the

message “Recording failed”

Cuff not tight or inated properly,

talk or walk while measuring and the

measurement is out of range.

Adjust the cuff, hold still,

and measure again.

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19 Specications

Powersupply 3.7V 1000mAh Built-in rechargeable

Power supply li-polymer battery, 5V 1A AC Adaptor (Optional)

Measurementmode Oscillometric testing mode

Measurementrange

Rated cuff pressure : 0mmHg~299mmHg (0kPa ~ 39.9kPa)

Measurement pressure : SYS : 60mmHg~230mmHg (8.0kPa~30.7kPa)

DIA : 40mmHg~130mmHg (5.3kPa~17.3kPa)

Pulse value : (40-199)beat / minute

Accuracy

(accordingtotheclinicalevaluation)

Aktiia Init I1 complies with the accuracy requirements of ISO 81060-2

Blood Pressure : Mean error ± 5mmHg / Standard deviation ± 8mmHg

Pulse value : ± 5%

Normalworkingcondition

A temperature range of : +5°C to +40°C

A relative humidity range of 15% to 90%, non-condensing,

but not requiring a water vapour partial pressure greater than 50 hPa

An atmospheric pressure range of :

700 hPa to 1060 hPa

Storage&transportationcondition Temperature : -5°C to +50°C

A relative humidity range of ≤ 93%, non-condensing, at a water vapour pressure up to 50hPa

Measurementperimeterofthearm About 22cm-42cm (8 ¾ to 16 ½ inches)

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Weight Approx.271g

Externaldimensions Approx.74.3mm×28.2mm×133mm

Attachment USB Cable and user manual

Modeofoperation Continuous operation

Degreeofprotection Type BF applied part

Protectionagainst

ingressofwater

IP22 : The rst number 2 : Protected against solid foreign objects of 12,5mm Ф and greater.

The second number : Protected against vertically falling water drops when enclosure titled up to 15º.

Vertically falling drops shall have no harmful effects when the enclosure is titled at any angle up to

15º on either side of the vertical.

Deviceclassication

Battery Powered Mode : Internally Powered Medical Electrical Equipment

AC Adaptor charged Mode : Class II Medical Electrical Equipment (the optional AC Adaptor shall

comply with the requirement of IEC 60601-1 or 60950)

Datatransfer

Bluetooth Low Energy (BLE)

Operating Frequency : 2402 MHz – 2480 MHz

Type of Modulation : GFSK

Transmission power : max. 4 dBm

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20 EMCandRFstatements

Aktiia Init I1 needs special precautions regarding EMC and needs to be installed and put into service according to the EMC information

provided in the following section.

The device is suitable for home healthcare environments.

Aktiia Init is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled.

Interference may occur in the vicinity of equipment marked with the following symbol .

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.

Use of accessories, transducers and cables other than those specied 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.

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 the device, including cables specied by the manufacturer. Otherwise, degradation of the performance of this equipment could result.

Aktiia Init I1 is not suitable for use in MRI

(Magnetic Resonance Imaging) environment.

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21 Electromagneticcompatibilityinformation

Guidanceandmanufacture’sdeclaration-electromagneticemissions

Aktiia Init is intended for use in the electromagnetic environment specied below.

The user of Aktiia Init should ensure that it is used in such an environment.

Aktiia Init is suitable for use in “Home Healthcare Environment”, i.e. all establishments, including domestic establishments and those directly connected