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

2 – EN
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.

3 – EN
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.

4 – EN
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.

5 – EN
• 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.

6 – EN
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 :

7 – EN
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

8 – EN
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.

9 – EN
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.