Kinetik Wellbeing TMB-2088 User manual

Guangdong Transtek Medical Electronics Co., Ltd.
Zone A, No.105, Dongli Road, Torch Development
District, 528437 Zhongshan, Guangdong, China
EC REP Medical Device Safety Service GmbH
Schiffgraben 41, 30175 Hannover, Germany Kinetik TMB-2088 UK IB 20210914
User Manual
Smart Blood Pressure Monitor
Thank you very much for selecting the Kinetik Wellbeing Smart Blood
Pressure Monitor.
Please read the user manual carefully and thoroughly so as to ensure
the safe usage of this product, keep the manual safe for future reference
in case you have problems.
TMB-2088

INTRODUCTION....................................................................................................................3
SUPPORT..............................................................................................................................2
General Description
Indications for Use
Contraindications
Measurement Principle
Safety Information
Display and Symbols
Name of Each Part
Contents/Product Includes
BEFORE YOU START..........................................................................................................10
The Choice of Power Supply
Installing and Replacing the Batteries
Setting the Date and Time
Setting a user ID
Pair a smart device with the monitor
MEASUREMENT..................................................................................................................18
Applying the cuff
Start a Measurement
DATA MANAGEMENT..........................................................................................................22
Recall the Records
Delete the Records
INFORMATION FOR USER.................................................................................................26
Tips for measurement
Maintenance
ABOUT BLOOD PRESSURE...............................................................................................28
What are systolic pressure and diastolic pressure?
What is the standard blood pressure classification?
Irregular heartbeat 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.........................................................................................................31
SPECIFICATIONS................................................................................................................32
AUTHORISED COMPONENT .............................................................................................33
CONTACT INFORMATION...................................................................................................33
EMC GUIDANCE.................................................................................................................34
TABLE OF CONTENTS
1
EU Declaration of Conformity (DoC).....................................................................................33

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…
Phone:
[phone]
Live Chat:
Simply visit www.kinetikwellbeing.com and send us a message.
Email:
[email protected]
Post:
Kinetik Medical Devices Limited
Unit 3, Perrywood Business Park, Honeycrock Lane,
Salfords, Redhill. RH1 5DZ
Support
SUPPORT
2
General Description
Indications for Use
Measurement Principle
The Kinetik Wellbeing Smart Blood Pressure Monitor is a digital monitor
intended for use in measuring the blood pressure and pulse rate of those
with an arm circumference ranging from 22 cm to 42 cm.
It is intended for indoor, adult use only.
1.The device is not suitable for use on women who are or may be pregnant.
2.The device is not suitable for use on patients with implanted, electrical
devices, such as cardiac pacemakers or defibrillators.
Contraindications
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.
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INTRODUCTION
Thank you for selecting Kinetik Wellbeing Smart Blood Pressure Monitor
(TMB-2088). The monitor features blood pressure measurement, pulse
rate measurement and the result storage.
The design provides you with two years of reliable service.
FEATURES:
• 124 mm × 76 mm Digital LCD display
• Systolic, Diastolic Blood Pressure & Pulse Display
• Date / Time Indication
• Irregular Heartbeat detection
• 2 × 250 memory storage, Guest mode available
• Up-to-date measuring-during-inflation technology

Safety Information
The symbols below might be in the user manual, labeling or other
component. They are the requirement of standard and using.
Symbol for “The operation guide must be read”
Symbol for “Class II Equipment”
Symbol for “Manufacturer”
Symbol for “Serial Number”
Symbol for “Type BF applied parts”
Symbol for “Direct Current”
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”
For indoor use only
Symbol for “Manufacture date”
SN
Symbol for “Recycle”
Indicates the need for the user to consult the instructions for
use for important cautionary information such as warnings
and precautions that cannot, for a variety of reasons, be
presented on the medical device itself.
Symbol for “Complies with MDD 93/42/EEC requirements”
Symbol for “European Authorised Representative (EC Rep)”
EC REP
INTRODUCTION
4
CAUTION
* This device is intended for indoor, home use.
* This device 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 no-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
unless otherwise instructed by a medical professional.
* Do not use on women who may be or are pregnant, including pre-eclamptic patients
* The device is not suitable for use on patients with implanted, electrical devices, such as cardiac
pacemakers or defibrillators.
* The effectiveness of this device has not been established for use:
-on users with common arrhythmias such as atrial or ventricular premature beats or atrial
fibrillation,
-on users with peripheral arterial disease,
-on users undergoing intravascular therapy, or with arteriovenous (AV) shunt.
Consult a medical professional before use.
* Do not use this device for diagnosis or treatment of any health problem or disease. Contact your
physician if you have or suspect any medical problem. Do not change your medications without
the advice of your physician or health care professional.
* If you are taking medication, consult your physician 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.
* Report any unexpected operation or events to the manufacturer.
* Do not apply the cuff on an arm that has an intravenous drip or a blood transfusion attached.
* Warning: 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 in
injury
* Warning: Taking blood pressure measurements too frequently could disrupt blood circulation and
cause injuries.
*Warning: Do not apply cuff to areas on patient where skin is delicate or damaged. Check cuff site
frequently for irritation.
* Warning: 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.
* 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 that the operation of the device does not result in prolonged impairment of patient
blood circulation.
* Warning: 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.
* Warning: Do not use this device with high-frequency (HF) surgical equipment at the same time.
5
INTRODUCTION

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Systolic blood pressure reading
Blood pressure level
See the blood pressure classifcation on page 28-29
Diastolic blood pressure reading
Pulse display
Pulse rate appears after the measurement.
Heartbeat symbol
Flashes when decteted during a measurement.
Irregular heartbeat symbol
Appears when decteted during a measurement.
Refer to page 29 for more information.
Average value symbol
Appears when viewing the average value of the latest 7 days under
the memory mode.
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SYMBOL EXPLANATION
CAUTION
* Warning: This device is not AP/APG equipment. Do not use the device where flammable
anesthetic are present, or in environments mixture with air of with oxygen or nitrous oxide.
* 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.
* You can use this device to take your own measurement, no third-party operator is required.
* 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.
* Warning: Excessive cuff tube lengths could cause strangulation if you don't manage them
properly.
* Warning: Do not touch output of the batteries/adapter and the user simultaneously.
* Adapter is specified as a part of ME EQUIPMENT.
* Warning: 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.
* The blood pressure monitor, its adapter, and the cuff are suitable for use within the patient
environment.
* Warning: Do not use this device if you are allergic to polyester, nylon, or plastic.
* Warning: Only use accessories approved by manufacturer. Using unapproved accessories
might cause damage to the unit and injure users.
* Warning: 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.
* No calibration is required within two years of reliable service.
* Do not attempt to repair the unit yourself if it malfunctions. Only have repairs carried out by
authorised service centers.
* At the request of authorised service personnel, circuit diagrams, component part lists,
descriptions, and calibration procedures will be made available by the manufacturer or
distributor.
* 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).
* Warning: Do not use the device while under maintenance, or being serviced.
* 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.
* Warning: Keep the device, cuff, and batteries away from children as they may pose a risk of
choking or strangulation if used improperly.
* Clean both device and cuff with a soft, dry cloth. If necessary use a dampened cloth and natural
detergent. Do not use alcohol, benzene, or other harsh chemicals.
* 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.
* Dispose of accessories, detachable parts, and the device according to the local guidelines.
INTRODUCTION
6
Display and Symbols
7
INTRODUCTION