Kinetik TMB-2296-B Smart All In One Blood Pressure Monitor

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User Manual Installation Instruction
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User Manual

This is the main product document for model TMB-2296-B.

The file format is pdf, 15 pages, you can download this manual here .

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User Manual
Smart All-In-One
Blood Pressure Monitor
Kinetik_TMB-2296-B_UK_IB_20240424_v8
Arm Type
Thank you for selecting the Kinetik Wellbeing Smart All-In-One Blood
Pressure Monitor.
Please read the user manual carefully and thoroughly, this is to ensure
the safe usage of the product. Please keep the user manual for future
reference.
Guangdong Transtek Medical Electronics Co., Ltd.
Zone A, No.105, Dongli Road, Torch Development
District, 528437 Zhongshan, Guangdong, China
EC REP
MDSS GmbH
Schiffgraben 41, 30175 Hannover, Germany
Made in China
TMB-2296-B
TMB-2296-B
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SUPPORT.............................................................................................................................3
INTRODUCTION..................................................................................................................4
General Description
Indications for Use
Measurement Principle
Receiving and Inspecting your Monitor
Safety Information
LCD Display Signal
Product Components
Contents/Product Includes
BEFORE YOU START........................................................................................................10
Power Supply and Charge Power
Activate Your Blood Pressure Monitor
Pair a smart device with the monitor
MEASUREMENT................................................................................................................15
Tie the Cuff
Start the Measurement
INFORMATION FOR USER...............................................................................................19
Tips for measurement
Maintenances
ABOUT BLOOD PRESSURE.............................................................................................21
What are systolic pressure and diastolic pressure?
What is the standard blood pressure classification?
Irregular pulse rate detector
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?
TROUBLESHOOTING........................................................................................................23
SPECIFICATIONS..............................................................................................................24
AUTHORIZED COMPONENT ...........................................................................................25
CONTACT INFORMATION.................................................................................................25
EMC GUIDANCE................................................................................................................26
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Table of Contents
SUPPORT
CONTENTS
2
Our manual should provide you with all the information you need
to set up and use this product.
If you have a question, have a look at our Troubleshooting page!
For further assistance, why not contact our Customer Care team
directly? We’re here to help!
Our Customer Care team are available from 9am-5pm, Monday to
Friday (excluding bank holidays).
We promise to respond to all queries and will ensure to resolve any
issue you may be having.
You can reach us by…
Live Chat:
Simply visit www.kinetikwellbeing.com and send us a message.
Email:
Post:
Kinetik Medical Devices Limited
Unit 11, Perrywood Business Park, Honeycrock Lane,
Salfords, Redhill. RH1 5DZ
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Thank you for selecting the Kinetik Wellbeing Smart All-In-One Blood
Pressure Monitor. The monitor features blood pressure measurement,
pulse rate measurement and the result storage. The blood pressure monitor
provides you with two years of reliable service.
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Readings taken by the TMB-2296-B 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.
Read the manual thoroughly before using the product.
General Description
INTRODUCTION
INTRODUCTION
Indications for Use
This Blood Pressure Monitor is a digital monitor intended for use in measuring
blood pressure and pulse rate with arm circumference ranging from 22cm to 32cm
(about 8¾˝-12½˝) or 22cm to 42cm (about 8¾˝-16½˝).
It is intended for adult indoor use only.
Safety Information
The signs below might be in the user manual, labeling or other
component. They are the requirement of standard and using.
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 by beat-to-beat pulsatile, which is used to
determine the systolic and diastolic pressure, and also pulse rate.
Check that the device packaging has not been tampered with and make sure
that all contents are present. Before use, ensure that there is no visible damage
to the device or accessories and that all packaging material has been removed.
If you have any doubts, do not use the device and contact Kinetik Wellbeing.
Receiving and Inspecting your Monitor
Features:
Systolic, Diastolic Blood Pressure & Pulse Display
Measuring-during-inflation technology
Digital LCD display
Manufacturer
Serial Number
Type BF applied part
Direct Current
The symbol indicates that the product should not be discarded
as unsorted waste but must be sent to separate collection
facilities for recovery and recycling.
Recyclable
Caution
Indicates that caution is necessary when operating the device or
control close to where the symbol is placed, or that the current
situation needs operator awareness or operator action in order
to avoid undesirable consequences.
Manufactuer Date and
Made in China
For indoor use only
Class II Equipment
MD
Medical Device
EC REP
Authorized representative in the European Community/ European Union
CE marking indicates that a product has been assessed by the
manufacturer and deemed to meet EU safety, health and
environmental protection requirements. It is required for products
manufactured anywhere in the world that are then marketed in the EU.
Refer to instruction manual/booklet
To signify that the instruction manual/ booklet must be read.
Note: The background color of the symbol is blue.
Symbol for Commercial
Product Code / Model
Number
Symbol for Batch Code
The first characteristic numeral symbol for “Degrees of protection
against access to hazardous parts and against solid foreign
objects.” The second characteristic numeral symbol for “Degrees
of protection against ingress of water.”
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INTRODUCTION
INTRODUCTION
Precaution
* This device is intended for indoor, home use and is not intended for public use.
* This device is portable, but it is not intended for use during patient transport.
* This device is not suitable for continuous monitoring during medical emergencies or operations.
* 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 any purpose other than
obtaining a blood pressure measurement.
* This device is for adults. Do not use this device on neonates or infants. Do not use it on children
and adolescents unless otherwise instructed by a healthcare professional.
* Consult with a healthcare professional before using this monitor if you suffer from the
following conditions: common arrhythmias such as premature ventricular beats or atrial
fibrillation; peripheral arterial disease; implantation with electrical devices; undergoing
intravascular therapy; arteriovenous shunt or mastectomy.
Please note that any of these conditions may affect measurement readings,in addition to patient
motion, trembling or shivering.
* Do not use this device for diagnosis or treatment of any health problem or disease. Contact
a healthcare professional if you have or suspect any medical problem. Do not change your
medications without the advice of a healthcare professional.
* If you are taking medication, consult a healthcare professional to determine the proper time to
measure your blood pressure.
* This device may be used only for the intended use described in this manual, the manufacturer
shall have no liability for any incidental, consequential, or special damages caused by misuse
or abuse.
* 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.
* The device may require up to 30 minutes to warm up / cool down from the minimum/ maximum
storage temperature before it is ready for use.
* The blood pressure monitor, its adapter, and the cuff are suitable for use within the patient
environment.
* Do not wash the cuff in a washing machine or dishwasher.
* The device contains sensitive electronic components. To avoid measurement errors, avoid
taking blood pressure measurements near a strong electromagnetic field radiated interference
signal or electrical fast transient/burst signal.
* Wireless communication equipment, such as wireless home network devices, mobile phones,
cordless telephones and their base stations, walkie-talkies may cause interference that may
affect the accuracy of measurements. A minimum distance of 1 foot (30 cm) should be kept from
such devices during a measurement.
* This blood pressure monitor is intended for use by medical or non-medical staff. A patient can
also be the intended user or operator.
* Do not attempt to repair the unit yourself if it malfunctions. Only have repairs carried out
by authorised service centers.
* It is recommended that the performance should be checked after repair, maintenance, and every
two years of use, by retesting the requirements in limits of the error of the cuff pressure indication
and air leakage (testing at least at 50 mmHg and 200 mmHg). Please contact Kinetik Wellbeing
for authorised service personnel.
* Store your device, cuff and adapter in a clean and dry place, protect it against extreme moisture,
heat, lint, dust and direct sunlight. Never place any heavy objects on it.
* Make sure the rubber tube of the cuff is not squeezed, stretched, or kinked during storage.
* Dispose of accessories, detachable parts, and the device according to any local guidelines.
Caution
* Do not apply the cuff on an arm that has an intravenous drip or a blood transfusion attached.
* Do not kink, fold, stretch, compress, or otherwise deform the tube during measuring, as the cuff
pressure might continuously increase, which could prevent blood flow and result injury.
* Taking blood pressure measurements too frequently could disrupt blood circulation and cause injuries.
* Do not apply cuff to areas on patient where skin is delicate or damaged. Check cuff site frequently
for irritation.
* Do not place the cuff on the arm of a person whose arteries or veins are undergoing medical
treatment, i.e. intra-vascular access or intra-vascular therapy or an arteriovenous (A-V) shunt,
which could disrupt blood circulation and cause injuries.
Warning
* Do not place the cuff on the arm on the same side of a mastectomy (especially when lymph nodes
have been removed), it is recommended to take measurements on the unaffected side.
* Do not wrap the cuff on the same arm to which another monitoring device is applied. One or both
devices could temporarily stop functioning if you try to use them at the same time.
* Please check (for example, by observation of the limb concerned) that the operation
of the device does not result in prolonged impairment of patient blood circulation.
* On the rare occasion of a fault causing the cuff to remain fully inflated during measurement, loosen
and remove the cuff immediately. Prolonged high pressure applied to the arm (cuff pressure
>300 mmHg or constant pressure >15 mmHg for more than 3 minutes) might lead to bruising and
discolored skin.
* Do not use this device with high-frequency (HF) surgical equipment at the same time.
* This device is not used in conjunction with oxygen rich environments, not intended for use with
flammable anaesthetics, not intended for use in conjunction with flammable agents.
* Do not touch output of the batteries/adapter and the user simultaneously.
* The power cord is considered the disconnect device for isolating this equipment from supply mains.
Do not position the equipment so that it is difficult to reach or disconnect.
* Do not use this device if you are allergic to polyester, nylon, or plastic.
* Only use accessories approved by manufacturer. Using unapproved accessories might cause
damage to the unit and injure users.
* If you experience discomfort during a measurement, such as pain in the arm or other complaints,
press the Power button immediately to release the air from the cuff.
* Do not use the device while under maintenance, or being serviced.
* The air tube poses a risk of strangulation. Furthermore, the small parts of product and batteries
present a choking hazard if swallowed. They should therefore always be kept away from
infants/children.
* Sensor degradation or looseness may reduce performance of device or cause other problems.
* You can use this device to take your own measurement, no third-party operator is required.
* Adapter is specified as a part of the ME (Medical Electrical) Equipment.
* At the request of authorised service personnel, circuit diagrams, component part lists, descriptions,
and calibration procedures will be made available by Kinetik Wellbeing.
* The expected lifetime of the cuff may vary by the frequency of washing, skin condition, and storage
state.
* Please report to the manufacturer and the competent authority of the country in which you are
established about any serious incident that has occurred in relation to this device.
Notice
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LCD display signal
INTRODUCTION INTRODUCTION
CUFF
LCD DISPLAY
START/ STOP/SET/USER SWITCH BUTTON
Contents/Product Includes
• Blood Pressure Monitor (TMB-2296-B)
• Cuff (Type BF applied part)
Upper arm cuff: 22-42cm.
• User manual
• Type-C cable & Adapter (Optional!)
Product Components
Cuff wearing
The cuff is secured.
SYMBOL
DESCRIPTION
EXPLANATION
Irregular pulse rateIrregular pulse rate
Pulse rate
Pulse rate dectetion during measurement
Systolic blood pressure
High pressure result
Diastolic blood pressure
Low pressure result
Battery Indicator
Indicate the current battery
Data transmitting
Data is transmitting
Indicate the bluetooth is working.
Bluetooth icon
Hand shaking
Hand shaking makes results inaccurate
Pulse display
Pulse in beats per minute
mmHg
Measurement unit of blood pressure
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BEFORE YOU START
BEFORE YOU START
1. This blood pressure monitor has a built-in, rechargeable
li-polymer battery. The battery current is 1000 mAh.
2. Please use the Type-C cable and AC adapter to charge
the battery, just like the following picture:
Power Supply and Charge Power
Charging the power under following circumstances:
bAt Lo displays on the LCD
The LCD display is dim.
When powering on the monitor, the LCD doesn’t light up.
CAUTION
* The battery of TMB-2296-B is a built-in rechargeable lithium-ion battery,
please do not disassemble it.
* If the battery is not recharging, or the blood pressure monitor is not
working as usual, please contact Kinetik Wellbeing. When fully charged,
the blood pressure monitor will take 100 measurements.
* Ensure to store and use the blood pressure monitor in cool, dry and
ventilated environments. Avoid storing or using the device near an open
fireplace or heat source, as it could cause the battery to explode.
* Only can use the authorised AC Adaptor (Model: BLJ06L050100U-B)
to charge. You cannot use the blood pressure monitor whilst charging.
* Whilst charging, the LED indicator of the START/STOP button will light
up. When charging is complete, the LED indicator will stop lighting up.
Please unplug the blood pressure monitor from the charging socket.
CAUTION
• 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.
Type-C cable
AC adapter
When you first use the Blood Pressure Monitor, the first thing you
must do is activate it. Press and hold the “START/STOP” button for
about 5 seconds to activate the device.
Activate Your Blood Pressure Monitor
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BEFORE YOU START
BEFORE YOU START
Pair a smart device with the monitor
You are the intended operator of this blood pressure monitor. After measuring
your blood pressure, data will automatically be sent to a smart device (such as
smartphone or tablet), so long as there is Bluetooth connectivity. If there isn't,
the blood pressure monitor will store up to 2 user x 199 measurements. The
blood pressure monitor will automatically send the measurements once a
connection is re-established.
List of compatible devices:
For iOS devices:
The operating system must be iOS 13.0 or more.
The operating system must be Android 5.0 or more.
For Android devices:
About a wireless communication interference
The monitor operates in the unlicensed ISM band at 2.4 GHz. In case it is used
around the other wireless devices including microwave and wireless LAN, which
operate at the same frequency band as the monitor, there is a possibility that
interference occurs between the monitor and such other devices. If such
interference occurs, please stop the operation of other devices or relocate the
monitor before using it or do not use it around the other wireless devices.
Warning
Note:
1. The necessary Quality of Service (QoS) is fully considered here for wirelessly enabled
functions.
2. Interference may occur in the vicinity of equipment marked with the following symbol .
And TMB-2296-B may interfere the vicinal electrical equipment.
3. Keep the monitor at least 20 centimeters away from the human body (especially the
head) when data transmission is proceeding after measurement.
4. To enable the data transmission function, this device shall be paired to an appropriate
BT mobile terminal.
Specifications for Bluetooth Transmission
Bluetooth
Throughput
2.5K-5K
Latency
50ms
PER
10%
Operating Frequency 2400-2480MHz
Transmission Power
0dBm
Transmission Distance
10m
3.
When the monitor is off, press
and hold the “MEM” button to
start pair-up, the bluetooth
symbol will flash.
4.
If successful, the bluetooth symbol will not flash any more and the
monitor will automatically shut off after several seconds.
Note:
1. The date and time on your monitor will automatically be set after paired with
your smart device successfully.
2. The device can also enter the Bluetooth pairing automatically when the
battery is installed for the first time.
If unsuccessful within 60 seconds, it is judged timeout and the monitor will shut off.
2.
Enable Bluetooth and the MedM Health app on your smart device.
Make sure both Bluetooth and app are ON when pair-up is proceeding.
5.
In the app, select the menu in the top left corner of the screen. Then
select 'My Devices'.
7.
Once selected you will be asked if you would like to receive data
automatically. If no, you will need to manually input results. If yes, you
will then be asked if you want to receive data in the background.
6.
At the bottom of the screen select 'Add New'. This will automatically
start scanning for a new device.
When detected, select the TMB-2296-B.
1. Download the Blood Pressure Diary by MedM app or the MedM
Health app from the App store or Google Play.
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BEFORE YOU START
MEASUREMENT
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Setting a user ID
There are 2 user ID available. User 1 and User 2, each with 199 memory
spaces, this means that 2 different people can save their measured values
separately.
2.
When you have selected the correct User ID, do not press anything,
simply wait a moment until the User ID is no longer flashing. The blood
pressure monitor will start the measurement in a few seconds.
1.
When the monitor is off, press the “START/STOP” button to display
the current user ID and flash. Press the “START/STOP” button again
to switch the user ID between the User 1 and User 2.
User 1
User 2
Tie the Cuff
1.
2.
3.
4.
5.
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.
Roll or push up your sleeve to expose skin.
Apply the cuff to your arm with your palm facing up.
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.
Sit comfortably with your 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.
Rest for 5 minutes before first measurement.
Wait at least 3 minutes between measurements. This allows your blood circulation to
recover.
The patient must relax as much as possible and do not move and talk during the
measurement procedure.
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 healthcare professional.
6.
7.
Take the measurement in a silent room.
The cuff should maintain 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.
Helpful tips for Patients, especially for Patients with Hypertension:
Only use a cuff that has been approved by Kinetik Wellbeing.
Before use, please confirm if it fits your arm circumference.
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Cuff wrap ok.
Inflating and measuring.
Display and save the
measurement result
Start the Measurement
Cuff wrap detection.
symbol “ ” flash.
If data transmission successful, the symbol “ ” will disappear first ,
after several seconds, “ ” will also disappear, and then the monitor
will turn off automatically.
If unsuccessful within 60 seconds, after 60 seconds of inactivity, the
blood pressure monitor will turn off.
Note
1. If you want to stop the measurement at any time, you can press the
“START/ STOP” button manually.
2. If there are previous untransmitted measurements, the symbol will
display on the screen at the beginning of the measurement.
3. Both User 1 and User 2 can store a maximum of 199 measurements
on the monitor. You can view your readings in the MedM Blood Pressure
Diary or MedM Health app, if your monitor is already paired with your
smart device.
MEASUREMENT
MEASUREMENT
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You can use your monitor without pairing to a smart device. To pair your
monitor with a smart device refer to page 12.
1. When the monitor is off, press the “START/STOP” button,
the current user ID will flash.
When you have selected the correct User ID, do not press anything,
simply wait a moment until the User ID is no longer flashing. The blood
pressure monitor will start the measurement in a few seconds.
Remain still and do not talk until the full measurement is complete.
(Take User 1 for example.)
Select user ID
3. If your monitor is already paired with your smart device and both
Bluetooth and app are ON, the measurement result will start transmitting.
2. Press the button to turn off the monitor, or it will shut off after
about 1 minute.
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Tips for Measurement
Within 1 hour
after dinner or drinking
Within 20 minutes
after taking a bath
In a very cold environment
Immediate measurement
after tea, coffee, smoking
When talking or moving your body
When you want to discharge urine
Measurements may be inaccurate if taken in the following
circumstances.
MEASUREMENT
4.
About the irregular pulse rate and excessive body motion during the
measurement.
During a measurement, if an irregular pulse rate is detected, the symbol
will display in the measurement result. See page 21 for more information.
During a measurement, if excessive body motion is detected, the symbol
will flash for about 5 seconds and repeat the measurement. If it is no
longer detected, the symbol will disappear. If still detected, the symbol
will be shown in the measurement result.
Note
The measured blood pressure reading may not be accurate if this symbol
is displayed.
MEASUREMENT
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INFORMATION FOR USER
What are systolic pressure and diastolic pressure?
press
artery
vein
blood discharging
Systolic
relax
blood entering
Diastolic
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.
What is the standard blood pressure classification?
Irregular Pulse Rate Detector
CAUTION
The appearance of the icon indicates that a pulse irregularity consistent with an irregular
pulse rate was detected during measurement. Usually this is NOT a cause for concern.
However, if the symbol appears often, we recommend you seek medical advice. Please
note that the device does not replace a cardiac examination, but serves to detect pulse
irregularities at an early stage.
An irregular pulse rate is detected when a pulse rate rhythm varies while the unit is
measuring the systolic and diastolic blood pressure.During each measurement, the
monitor records all the pulse intervals and calculate the average ; if there are two or more
pulse intervals ,the difference between each interval and the average is more than the
average value of ±25% , or there are four or more pulse intervals ,the difference between
each interval and the average is more than the average value of ±15%,the irregular
pulse rate symbol appears on the display when the measurement results are appeared.
ABOUT BLOOD PRESSURE
SYS
DIA
<120
<80
120~129
80~84
130~139
85~89
140~159
90~99
160~179
100~109
>180
>110
Level
Blood
Pressure
(mmHg)
The blood pressure classification published by
World Health Organization (WHO) and
International Society of Hypertension (ISH) in
1999 is as follows:
Optimal Normal
High-normal
Mild Moderate Severe
Maintenance
In order to get the best performance, please follow the instructions
below.
1. Cleaning Process:
Step 1: Make sure to switch off and unplug the device prior to cleaning.
Step 2: Use a soft cloth and dampen it with soapy water to clean the cuff
first, and then use a soft cloth and damped it with clear water to
remove residual soap until there is no visible residual
contaminants. Attention shall be paid to avoid liquid leaking into
the cuff.
Step 3: Use a dry soft cloth to wipe the cuff, in order to remove residual
moisture.
Step 4: Dry the cuff in a well-ventilated area after cleaning.
2. Disinfection Process:
Step 1: Make sure to switch off and unplug the device prior to disinfection.
Step 2: Use a soft cloth with 70% isopropanol to disinfect the cuff
for about 10 minutes. Attention shall be paid to avoid liquid leaking
into the cuff.
Step 3: Use a clean dry cloth or towel to wipe off the disinfectant until
there is no visible residue.
Step 4: Dry the cuff in a well-ventilated area after disinfection.
Suggestion:
Frequency of Cleaning and Disinfection:
For single patient multiple use, it’s recommended to clean the device
surface once a month or whenever it’s necessary.
For multiple patient multiple use, it’s recommended to clean the device
every time before and after usage. Maintenance procedures shall be
taken as per instruction.
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Approx.206g
A01
Digital LCD V.A.72mm × 22mm
Approx.123 mm×44 mm×22 mm
user manual, type-c cable, adapter (Optional!)
Contact Information
Authorized Component
Please use the authorized adapter (not included).
SPECIFICATIONS
AUTHORIZED COMPONENT
For more information about our products, please visit:
www.kinetikwellbeing.com
3.6V 1000mAH Built-in rechargeable li-polymer
battery, 5V 1A AC Adaptor(Optional!)
Input: 100-240V, 50-60Hz, 0.2A max
5V 1000 mA
Adapter
Type: BLJ06L050100U-B
Output:
About 22cm~42cm
Type BF applied part
WARNING: No modification of this equipment is allowed.
Power supply
Display mode
Measurement mode
Oscillographic testing mode
Measurement range
Measurement perimeter
of the upper arm
Weight
External dimensions
Attachment
Mode of operation
Continuous operation
Degree of protection
Protection against
ingress of water
Accuracy
Normal working condition
Storage & transportation
condition
Software Version
Rated cuff pressure:
0mmHg~299mmHg
Measurement pressure:
SYS: 60mmHg~230mmHg
DIA: 40mmHg~130mmHg
Pulse value: (40-199)beat/minute
IP22 It means the device could be protected against
solid foreign objects of 12,5mm Ф and greater, and
against vertically falling water drops when enclosure
titled up to 15º.
Device Classification
Battery Powered Mode:
Internally Powered ME Equipment
AC Adaptor Powered Mode:
Class II ME Equipment
Temperature:-20°C to +60°C
A relative humidity range of ≤ 93%, non-condensing,
at a water vapour pressure up to 50 hPa
An atmospheric pressure range of 500 hPa to 1060 hPa
Device(with the cuff): 3 years or 10000 times
(may vary based on usage conditions)
Battery: About 100 times after fully charged
Expected Lifetime
Types of use/reuse
Multiple patient multiple use
A temperature range of: +5°C to +40°C
A relative humidity range of 15% to 90%,
non-condensing, but notrequiring a water vapour
partial pressure greater than 50 hPa
An atmospheric pressure range of 700 hPa to 1060 hPa
Static Pressure: 5°C-40°C within ±3mmHg
Pulse value: ±5%
Clinical validation: Mean difference within ±5mmHg
Standard deviation≤8mmHg
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EMC GUIDANCE
EMC GUIDANCE
Technical description
1. All necessary instructions for maintaining BASIC SAFETY and
ESSENTIAL PERFORMANCE with regard to electromagnetic disturbances
for the excepted lifetime.
2. Guidance and manufacturer’s declaration-electromagnetic emissions and
Immunity.
Table 1
Guidance and manufacturer’s declaration - electromagnetic emissions
RF emissions
CISPR 11
RF emissions
CISPR 11
Group 1
Class [ B ]
Class A
Comply
Compliance
Harmonic emissions
IEC 61000-3-2
Voltage fluctuations /
flicker emissions
IEC 61000-3-3
Emissions test
EMC Guidance
The ME EQUIPMENT or ME SYSTEM is suitable for home healthcare environ-
ments.
Essential performance:
Accuracy of measuring blood pressure and pulse rate
The Basis Safety of the Blood Pressure Monitor (TMB-2296-B) is as following:
Deviation from normal operation that poses an unacceptable risk to the patient or
operator.
Warning: Don’t be near the active HF surgical equipment and the RF shielded
room of an ME system for magnetic resonance imaging, where the intensity of EM
disturbances is high.
Warning: 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.
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 the equipment including cables specified by the manufactur-
er. Otherwise, degradation of the performance of this equipment could result.
Measurement Range
Systolic pressure: 60-230 mmHg
Diastolic pressure: 40-130 mmHg
Pulse: 40-199 beats/minute
Rated Cuff Pressure
0-299 mmHg (0-39.9 kPa)
Accuracy
Pressure: ±3 mmHg / 0.4 kPa
Pulse: ±5%
background
28
EMC GUIDANCE
Table 2
Guidance and manufacturer’s declaration – electromagnetic Immunity
Immunity Test
±8 kV contact
±2 kV, ±4 kV, ±8 kV, ±15 kV air
±8 kV contact
±2 kV, ±4 kV, ±8 kV, ±15 kV air
±2 kV for power supply lines
±1 kV signal input/output
100 kHz repetition frequency
±2 kV for power supply lines
Not applicable
100 kHz repetition frequency
±0.5 kV, ±1 kV differential mode
±0.5 kV, ±1 kV, ±2 kV common mode
±0.5 kV, ±1 kV differential mode
30 A/m
50 Hz / 60 Hz
30 A/m
50 Hz / 60 Hz
NOTE U
T
is the a.c. mains voltage prior to application of the test level.
Compliance level
Electrostatic
discharge (ESD)
IEC 61000-4-2
Power frequency
magnetic field
IEC 61000-4-8
Voltage dips, short
interruptions and
voltage variations
on power supply
input lines
IEC 61000-4-11
Electrical fast
transient/burst
IEC 61000-4-4
Surge
IEC61000-4-5
IEC 60601-1-2
Test level
0% U
T
; 0,5 cycle. At 0°, 45°, 90°, 135°,
180°, 225°, 270° and 315°.
0% U
T
; 1 cycle and 70% U
T
;
25/30 cycles; Single phase: at 0°.
0% U
T
; 250 / 300 cycle
0% U
T
; 0,5 cycle. At 0°, 45°, 90°, 135°,
180°, 225°, 270° and 315°.
0% U
T
; 1 cycle and 70% U
T
;
25/30 cycles; Single phase: at 0°.
0% U
T
; 250 / 300 cycle
Conduced RF
IEC61000-4-6
3 V
0,15 MHz – 80 MHz
6 V in ISM and amateur radio bands
between 0,15 MHz and 80 MHz
80% AM at 1 kHz
3 V
0,15 MHz – 80 MHz
6 V in ISM and amateur radio bands
between 0,15 MHz and 80 MHz
80% AM at 1 kHz
10 V/m
80 MHz – 2,7 GHz
80% AM at 1 kHz
10 V/m
80 MHz – 2,7 GHz
80% AM at 1 kHz
Radiated RF
IEC61000-4-3
Table 3
385 0.3 27
Service Modulation
380-390 1.8
450 430-470 2 0.3 28
710
704-787
745
780
0.2 0.3 9
810
870
930
800-960 2 0.3 28
2 0.3 28
2 0.3 28
0.2 0.3 9
1720
1845
1970
1700-
1990
2450
2400-
2570
5240
5500
5785
5100-
5800
Guidance and manufacturer’s declaration - electromagnetic Immunity
Test
Frequency
(MHz)
Radiated RF
IEC61000-4-3
(Test
specifications
for
ENCLOSURE
PORT
IMMUNITY to
RF wireless
communicati-
ons
equipment)
Band
(MHz)
Distance
(m)
IEC
60601-1-2
Test Level
(V/m)
TETRA
400
Pulse
modulation
18 Hz
GMRS 460,
FRS 460
FM ± 5k Hz
deviation
1 kHz sine
LTE Band
13,
17
Pulse
modulation
217 Hz
GSM
800/900,
TETRA 800,
iDEN 820,
CDMA 850,
LTE Band 5
Pulse
modulation
18 Hz
GSM 1800;
CDMA 1900;
GSM 1900;
DECT;
LTE Band 1,
3, 4,25;
UMTS
Pulse
modulation
217 Hz
Bluetooth,
WLAN,
802.11
b/g/n, RFID
2450, LTE
Band 7
Pulse
modulation
217 Hz
WLAN
802.11
a/n
Pulse
modulation
217 Hz
Compliance
level
(V/m)
27
28
9
28
Maximum
Power
(W)
28
9
28
EMC GUIDANCE
29

Specifications

Kinetik TMB-2296-B Questions and Answers

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