KF-65B User Manual

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Cofoe Electronic Blood Pressure Monitor (Arm type)

User Manual
( K F -6 5 B )

Please read the User Manual carefully before using this product
Catalogue
Preface--------------------------------------------------------------------------------------------------------------------------1
1. Product information------------------------------------------------------------------------------------------------------2
2. Specification and parameters---------------------------------------------------------------------------------------- 3
3. Precautions---------------------------------------------------------------------------------------------------------------- 4
4. Battery installation------------------------------------------------------------------------------------------------------- 6
5. Ready measurement-------------------------------------------------------------------------- 7
6. Take measurements-----------------------------------------------------------------------------------------------------8
7. Measurement results, memory and query--------------------------------------------------------------------- 10
8. Display unit, voice switch settings, memory clear and user switching----------------------------------11
9. Display fault prom pt---------------------------------------------------------------------------------------------------13
10. Clean and Maintenance------------------------------------------------------------------------------------------15
11. List of hazardous substance content------------------------------------------------------------------------ 17
12. Knowledge of blood pressure----------------------------------------------------------------------------------18
13. Blood pressure status --------- 20
14. Electromagnetic compatibility statement------------------------- 21
Preface

Thank you for choosing our Electronic Blood Pressure Monitor. To help you use it correctly, please
read this user manual carefully before use, and keep it properly after reading, so that you can
consult and refer to it at any time. Please do not lose the attached warranty card.
The illustrations in this manual are all renderings.
1. Product Information
The product is mainly made up of outer casing; air pump; solenoid valve; pressure sensor; PCB circuit board;
display screen.

Ange of application:
* The product measures the diastolic blood pressure, systolic blood pressure and pulse of the adult by oscillometric
method, and its value is used for diagnosis.
Contraindications:
* Severe arrhythmia is disabled and children are disabled.

Arm Cuff and air tube Accessories


(Arm Cuff: Applicable arm Trial dry battery (AA) 4
circumference 22cm~42cm) sections
*Note: The arm cuff can be *Since the dry
replaced by the user batteries are only used
Don't use non-manufacturer one, for trial, and can’t use
may cause measurement errors. for 300times

User Manual (Warranty


card)
Arm Cuff Air tube Air tube joint Certification card
2. Specification and parameters

Name: Electronic blood pressure monitor Pressure detection: Pressure sensor


Model: KF-65B Safety Mode Classification: Equipment that cannot be used in
Working mode: Automatic inflation, automatic the presence of flammable gases mixed with air or with
measurement oxygen or nitrous oxide
Device operation mode: Continuous working mode Arm Cuff: Applicable arm circumference 22cm~42cm
Display method: Digital display mode Mainframe dimensions: 140mmx110mmx81 mm
Measurement method: Oscillometric method Weight: about 280g (without battery)
Pressure detection range: 0.0kPa - 37.33KPa Applicable Power supply: DC6V/500mA or 4 AA dry batteries
(0mmHg - 280mmHg) Use environment: temperature +5 ° C ~ +40 ° C, humidity 15% ~ 85% RH

Pulse rate detection range: 40 times / minute - 199 Transportation and storage environment: temperature -20° C ~ +55 ° C,
times/minute hum idity 15% ~ 93% RH

Over voltage protection: 37.33KPa (280mmHg) Atm ospheric pressure 86kPa ~ 106kPa

Pressure indication error: ±0.4kPa (±3mmHg) If stored or used outside o f the temperature and humidity ranges

Classified by type of prevention electric specified above, the system may not meet the claimed perform ance

shock:lnternal power supply specifications.

Electrical safety type: BF type application part


Infusion protection classification: common type
equipment
3. Precautions
The warning symbols and illustrations shown in the manual are intended to enable you to use the product safely
and correctly and to prevent injury to you and others. Warning signs, legends and their meanings are as follows.

Warning symbols Content


There is a possibility of personal injury when using it incorrectly.

Illu s tra tio n s

General prohibition Prohibit disassemble


General coercion BF type application
The safety and environmental protection life of this product is 10 Indicates II types
years from the date of use. Consumable products are not included. of equipment
____________ .
N o te

• It is dangerous for patients to make self-judgment and self-treatment by measuring the results.
The measured blood pressure value should be interpreted by a professional.
• Patients with severe blood circulation disorders, blood diseases, please use under the guidance of doctors,
acute internal bleeding may result from compression of the arm during measurement.
• Be sure to use the special cuff supplied by the manufacturer. Otherwise it cannot be measured correctly.

• Newborns, children, and those who cannot express their own thoughts are disabled. May be the cause of an
accident or dispute.
• This product is only used for the measurement of human blood pressure and pulse. For purposes other than
measuring blood pressure and pulse, accidents may occur.
• The pressure of the cuff should be controlled below 280mmHg 37.33KPa. Otherwise, the arm may have
symptoms such as congestion and numbness.
• Do not use this on mobile vehicles (planes, cars). Otherwise, it cannot be measured correctly.

• Do not disassemble or repair the blood pressure monitor body or arm cuff.

Suggestion

• If the pressure is not applied during the measurement process or the pressure does not stop, immediately turn off
the main unit or pull out the cuff tubing plug and quickly vent.
• Please do not let the arm be inflated for a long time. When the airbag is in the state of persistent over-inflation,
there is a risk of damage to the arm.
• Be sure to pay attention to the following points when measuring blood pressure, otherwise the blood pressure
measurement may be inaccurate!
1. Do not eat, drink, drink coffee drink tea. smoke, exercise or bath for 30 minutes before the measurement.
Please rest for at least 15 minutes.
2. Please measure in the correct posture with a quiet body, stable mood, and no urine.
3. Please do not speak or move your body during the measurement process.
4. Do not measure in an environment that is too cold, overheated, or subject to extreme conditions.
5. Avoid strong electromagnetic interference when measuring, such as mobile phones, microwave ovens, etc.
6. When a common arrhythmia (such as early morning, early morning, atrial fibrillation, etc.) occurs, the maximum
value may be Inaccurate or unmeasurable.
7. This product Is only suitable for upper arm measurement and is not suitable for wrist and other parts
measurement.
8. Any blood pressure measurement is affected by the posture of the subject and his/her physical condition.

4. Battery installation
Remove the battery compartment cover of the main body, insert the battery according to the direction of the
electrode in the battery compartment, and re-cover the battery compartment cover.
Note:
1 . It is recommended to use AA alkaline battery (4 sections).
2 . Do not misfit the positive and negative poles of the battery.
3 . When there is a low power alarm during the measurement process, please
replace the battery (new and old batteries, different types of batteries do not
mix), even after the battery replacement measurement results will still be
stored in memory.
4 . When not using for a long time (more than 3 months), please take out the
battery and dispose of the used batteries properly to avoid polluting the
environment.
☆Use external power supply (optional)
If you use an external power supply, be sure to use a stable power supply that complies with safety standards.
5.Ready measurement
1. Arm cuff and air tube connection description:
©Insert the air tube socket into the left air tube socket of the body
© In order to make the plug more smooth, the method
of edge rotation and edge plug can be adopted
2. Tie and Roll arm cu ff instructions (see picture 1)
©Take off your coat, sweater, etc., and wear a thin coat or bare arm.
©Pass the end of the cuff through the iron ring, the air tube is facing
outward, and the strap is tied to the upper side of the elbow 2-3 cm.
Picture 1
©Palms upward, air tube straighten and the middle finger in the

and keep the center of the arm band flush with the heart. Picture 2
6. Taka maaauraments
*Thls product provides 192 memory measurement modes for both groups. The instruction explains that taking
group A measurement as an example, group B refers to the measurement operation of group A.
1. Press once [S tart/stop b u tto n ]

▼ Start up t Pressurized ▼ Venting ▼ Completed


• Start measuring
The machine starts and the cuff begins to automatically pressurize. Pressurize to a predetermined value, automatically
vent at a constant rate, detect blood pressure and pulse rate.
• Fast measuring
This blood pressure monitor pressurizes the process to predict high and low pressure, It makes those who with
low blood pressure show low blood pressure, and those who with high blood pressure show high blood pressure
shorten measurement time, each user can comfortably and quickly measure.
• Note: Please keep quiet and rest for 3 minutes before starting another measurement.
The rest time allows the artery to return to its pre-measurement state.
2. Press once [ON/OFF button] to turn off
3. Remove the cuff
• This device saves the measurement value automatically
• It has automatic turn off function and will power off if there is no other operations within 2 minutes.
• Note: If there is pressure or discomfort during the measurement, or if the pressure does not stop, press the
[Start/Stop] key to turn off the main unit or pull out the cuff air tube plug.*

* Note:
This product has an upper limit of 280mmHg 37.33KPa. Do not leave your arm inflated for a long time to avoid damage
to your arm. Do not pressurize to unnecessary pressure.
8. Display unit, voice switch settings, memory clear and user switching
* This product provides two display units, mmHg (mmHg) and kPa (kPa). The specification explains that taking
mmHg as an example, the factory default setting is mmHg as the display unit.
1. Shut down and press ! ► ! button (about 3 seconds) to enter setting status.

2. Press the ! ► ! key to cycle through the following settings.

Memory groups Display units Voice switch

* “ ” indicates the flashing status


3. Memory clearing
Adjust the second step to (Memory groups) is flashing, press once I ◄ ] button, modify this value to “0”.
*Some saved measurements cannot be deleted. If you want to delete, all measurements of the blood pressure
monitor will be deleted.
7. Measurement results, memory and query
1. The measurement results are shown in the figure 2. When there is a measurement error (the
below. High voltage: 128mmHg, low pressure: blood pressure monitor shows error E as shown in
.78mmHg, pulse: 72 times/min. The measurement result the figure below), please take a quiet rest for 3
is automatically saved, the serial number is 0, the minutes and then follow the operation procedure
previous result storage serial number is 1, and so on. of item 6 for the re-measurement.

Memory:
This unit can store two sets of measurement results. Each group can store up to 192 groups. If 192 groups have
been saved, when the 193th group is saved, the oldest measurement result will be deleted.
The serial number will appear for about 1 second before the maximum result is displayed. The latest set of
measurement results is "0".

Query:
Press the I ◄ ] button (as shown on the right) to check the saved data,
Press the I ◄ ] or [ ► ! button (as shown on the right) to view the previous or next set of memory data.
Voice switch setting
User switching setting

4. Display units setting: Adjust the second step to (Display units) is flashing, press once M l button.

5. Voice switch setting: Adjust the second step to (Voice switch) is flashing, press once M l button.

6.Save setting results: Press once IStart/Stopl button, turn it off, save setting results successfully.
Confirm the settings and return to the shutdown state.
* This product provides 192 memory measurement modes for each group. Press [► ] in the off state to complete A
or B user switching.
9. Display fault prompt
LCD error prompt and error cause correspondence table
Error Display reason Processing method
Low power Replace new batteries

Insufficient cuff pressure Please read and repeat the steps listed under Chapter 6

Air tube joint disconnected Plug in the air tube connector


In the measurement process, the arm,
Keep your body quiet and re-measure
body movement and other disturbances
E The inflation pressure is not 30mmHg Manually pressurize to meet the requirement of inflation
higher than the expected high pressure pressure
Cuffs are not tied correctly Correctly tying the cuff

Clothes pressure arm Take off the clothes of the oppressed arm and measure

Replace a new cuff


Cuff leakage Please call customer service for consultation
Phenomenon Possible reasons
The cuff is not tied up
E1 Not pressurized No cuff
Air leak
Measurement failure Read "Fault and Handling" or please call customer service for consultation.

Pressure greater than 280mmHg Check that if the trachea is folded o r the trachea plug is blocked
Safeguard and treatment

Anomalies Reasons Processing method


Cuffs are not tied correctly Correctly tying the cuff
The reading is too low
moves or speaks during measuring
(or too high) Please keep quiet during the measurement
process
Clothes pressed the arm Take off the clothes of the oppressed arm

The air tube joint is not firmly connected Make sure the air tube connector is securely
connected
Cuff pressure does not rise
Cuff leakage Replace a new cuff
Please call customer service for consultation

Cuff exhaust too fast Cuff roll tied too tight Please roll up the cuff correctly

Unable to measure or Please read and repeat the steps listed under
Insufficient pressure on the cuff
reading too high Chapter 6

Battery is exhausted Replace the battery with a new one


Can not boot
ReaBattery not installed properlysons Please install the battery with the correct
positive and negative poles
Press the start/stop button to re-measure
Other failure If the problem persists, try replacing the battery with a new one. In addition, still can't
measure, please call customer service to inquire
10. Clean and Maintenance
Maintenance method:
©Please clean the blood pressure monitor if necessary

© D o not put the blood pressure monitor and cuff in the high temperature, humidity, full of water vapor or direct
sunlight environment
© D o not tightly fold the cuff or air tube

© Do not remove the blood pressure monitor

© Do not allow the blood pressure monitor to be strongly impacted or vibrated, eg. by falling to the ground

© D o not clean the blood pressure monitor with corrosive liquids

©Clean the blood pressure monitor with a soft, dry cloth. If the product is particularly dirty, use a soft cloth
dampened with water or a neutral detergent, screw it on and wipe it off. If necessary, wipe it with absorbent cotton with
sterile alcohol
© D o not use gasoline, thinner or similar solvent to clean the cuff

©Clean the cuff with a soft damp cloth and soap

Environmental protection:
After reaching the end of life, please send it to the appropriate place to protect the environment.(Note: The disposal
of waste and residue shall conform to the relevant laws and regulations of the state.)
Calibration and repair
©The accuracy of this blood pressure monitor has been strictly tested and is generally recommended to be
checked and calibrated at least every two years to ensure normal function and accuracy of the blood pressure monitor.
It is carried out by a laboratory with metering qualification, manufacturer or through a manufacturer-authorized special
maintenance centre
© D o not carry out any maintenance by yourself. If the product has any quality problems or questions about the
correct measurement of the blood pressure monitor, please call the service number for consultation

Storage
Keep the blood pressure monitor in the package box when not in use
©Unplug the air tube connector from the air tube socket

©Gently fold the air tube into the cuff. Do not fold the air tube forcibly

©Keep the cuff and body in the box


• Do not put the machine in a place where it is easy to splash
• High temperature, humidity, direct sunlight, dusty or corrosive gas
• It is easy to tilt, it will produce vibration and impact
Static mode:
Press and hold the “Start/Stop” button and plug in the power to ente static pressure test mode.
11. List of hazardous substance content
The name and content of toxic or hazardous substances or elements in the product

Toxic or harmful substances or elements


Part name (Pb) (Hg) (Cd) Cr(VI) (PBB) (PBDE)

Circuit Board
(including LCD) O O O o o
Air pump,The
electromagnetic valve
O O O o o
Battery O O O o o o
Shell O O O o o o
Cuff o O o o o o
Package material o O o o o o
O : Means that the content of the toxic and harmful substances in all
homogeneous materials of the component is below the limit specified in the
2011-65-EU standard

X : indicates that the content of the toxic and hazardous substances at least in
a homogeneous material of the component exceeds the limit specified in
the 2011-65-EU standard
Does congestion occur during continuous measurement?
Q

A During the measurement, the arm is pressed to force the blood flow to the fingertips to cause congestion. In
the case of congestion, loosen the cuff, lift your hand over the top of the head, and repeat the grip and stretching
of the palms 15 times or so to clear the congestion.

QWhy does the cuff roll tie the arm and feel pain and numbness?

A This is a temporary phenomenon. Don't worry about it. When measuring blood pressure, the cuff needs to be
tightened to stop the flow of blood in the arteries temporarily, so the arm may feel some pain and numbness. When
the cuff is removed, a little rest will ease the pain.

Q When is the best time to measure blood pressure?

A The best time to measure blood pressure is within an hour of getting up in the morning, or before going to bed
at night

*lf you take your morning measurement, do it within 1 hour of waking up, after urination, before breakfast (if
you are taking blood pressure medication, before taking medication)

*lf night measurements are recommended before bedtime.

*lf it is other time, it is best to measure when the body and mood are in a stable state.
*lt is also recommended to test in the same time period every day.
12. Knowledge of blood pressure
Q Why is the blood pressure value measured different each time?

A
l
Is it measured at the same time?
During the day, even if measured every 10 seconds, blood pressure will change.
24-hour blood pressure level change chart

► Average blood pressure value

For proper blood pressure management, please measure the blood pressure at the same tim e every day

ABlood pressure fluctuates for a variety of reasons


Even at home, the following measurements will change
*Within 1 hour after a meal *After drinking alcohol, coffee and black tea
*After smoking *After the bath *After exercise
*After urination *Talk during measurement
*When you are upset because of nervousness or anxiety
*When the room temperature suddenly changes
*Measuring site or environment is not the same as in the past
13. Blood pressure status
Classification criteria for blood pressure status:
The World Health Organization (WHO) and the International Society of High Pressure (ISH) have developed blood
pressure classifications as shown in the following figure. This table is based on different ages, sitting in a chair in a
hospital, and blood pressure on the side upper arm.
Hypotension is not defined, and artificial hypotension is generally considered to be less than 100 mmHg (13.3 kPa).

Blood pressure classification by reference to WHO/ISH (revised in 1999)


14. Electromagnetic compatibility statement
KF-65B Electronic blood pressure monitor(Arm type) meets the electromagnetic compatibility requirements of
IEC 60601-1-2 standard.
Basic performance is: during the EMC test, the electronic sphygmomanometer (arm type) is running normally,
and the measurement mode pressure shows normal.
/ j \ Note:
•Users should install and use EMC information provided by random files.
•Portable and mobile radio frequency communication devices may affect the performance of KF-65B electronic
blood pressure and avoid strong electromagnetic interference such as proximity to mobile phones, microwave
ovens, etc.
•The guidelines and manufacturer's statement are attached.
•The minimum physiological signal was 40 mm Hg.
/ j \ Warning:
•The KF-65B electronic blood pressure should not be used close to or stacked with other equipment. If it must
be used close to or stacked, it should be observed to operate properly in the configuration in which it is used.
•in addition to the cables sold by the manufacturer of the KF-65B electronic blood pressure as spare parts for
internal components, the use of extra-standard accessories and cables may result in increased emissions or
reduced immunity of the KF-65B electronic blood pressure
•Inaccurate consequences of running the device or system below the minimum or minimum value described
above.
Table 1-4 below shows the electromagnetic compatibility of the KE-65B electronic sphygmomanometer (arm type)
Guide and manufacturer's statement-electromagnetic launch

KF-65B Electronic blood pressure is intended for use in the electromagnetic environment specified below. The purchaser or user o f this
Infrered thermometer should ensure that it is used in this electromagnetic environment:

Launch experiment Compliance Electromagnetic environment-guide

1 group KF-65B Electronic blood pressure uses RF e ne rg y only for its internal function.Therefore, its
RF emission
radio frequency emission is very low, and the possibility of interference with nearby electronic
Gb4824 B type equipment is very small.

Table2 - Guidance and Manufacturer's Declaration-Electromagnetic Immunity

Guidance and M anufacturer's Declaration-Electromagnetic Immunity

KF-65B Electronic blood pressure monitor is intended to be used in the electromagnetic environm ent specified below, and the purchaser or
user shall ensure that it is used in such electromagnetic environment:

Immunity test IEC60601Test level Consist level Electromagnetic environment one guide

The floor should be wood, concrete or ceram ic tile, if the floor


G B/T17626.2 6K V contact discharge 6KVcontactdischarge
is covered with synthetic material, the relative humidity
Electrostatic discharge 8K V air discharge 8KV air discharge
should be at least 30%

Power frequency electric Power freq uency m agnetic fields should have power
field (50-60HZ ) 3A/m 3A/m frequency m agnetic field characteristics o f typical locations
G B/T 17626.8 as the com mercial or hospital environment .
G uidance and Manufacturer's Declaration-Electromagnetic Immunity

KF-65B Electronic blood pressure monitor is intended to be used In the electrom agnetic environment specified below, and the purchaser
o r u ser shall ensure that it is used in such electromagnetic environment:_________________________________________________________ _ _

Immunity test IEC60601 test level Compliance level Electromagnetic Environm ent-Guide

Portable and mobile RF communication equipment should not be used near


any part of KF-65B than the recommended isolation distance, including
cables. This distance should be calculated using the formula for the
transmitter frequency. Recommended isolation distance:
G B/T17626.3 3V/m d=1.2VP 80MHz ~ 800MHz; d=2.3VP 800MHz - 2.5GHz
Radio frequency 3V/m In the formula: P— based on the maximum rated output power of the
80MHz~2.5GHz
conduction transmitter provided by the transmitter manufacturer in Watts (W);
d— The recommended separation distance in meter (m). b.
The field strength of the fixed RF transmitter is determined by surveying the
electromagnetic field a, and should be lower than the compliance level in
each frequency range b. Interference may occur near devices
marked with the following symbols.
Note 1: Formulas for higher frequency bands at frequencies o f 80M Hz and 800MHz
Note 2: These guidelines may not be suitable for all situations. Electromagnetic propagation is affected by the absorption and reflection
o f buildings, objects and human bodies. ____________________________________________________________________________________________
a Fixed transmitters, such as base stations for wireless (cellular/cordless) telephones and terrestrial mobile radios, am ateur radio, AM
and FM radio broadcasts, and television broadcasts, whose strong fields are theoretically not predictable in advance and are fixed for
assessm ent purposes. The electrom agnetic environment o f the RF transm itter shall take into account the survey of the electrom agnetic
field. If the measured field strength o f the infrared thermom eter is higher than the applicable RF compliance level, the infrared
therm om eter shall be observed to verify its normal operation. If abnorm al performance is observed, supplemental measures m ay be
necessary, such as reorienting or positioning the infrared thermometer.
b In the entire frequency range from 150KHz to 80MHz, the field strength should be lower than 3V/m __________________________________
Tibia 4 - Recommended spacing distance between portable and mobile radio frequency communication
equipment and KF-65B electronic blood pressure monitor
Recommended spacing distance between portable and mobile radio frequency communication equipm ent and KF-65B
•laotronlc blood pressure monitor
KF-65B electronic blood pressure monitor is expected to be used in an electromagnetic environm ent where radio frequency radiation
disturbance Is controlled. Depending on the maximum rated output power of the com munication device, the purchaser or user may
prevent electromagnetic interference by maintaining the minimum distance between the portable and mobile radio frequency
communication device (transmitter) and KF-65B electronic blood pressure monitor recom mended below

Transmitter maximum rated


output power W 80MHz~800MHz 800MHz~2.5GHz
d=1.2 VP d=2.3 VP

0.01 0.12 0.23

0.1 0.38 0.73

1 1.2 2.3

10 3.8 7.3

100 12 23

For the maximum rated output power o f the transmitter not listed in the above table, the isolation distance d is recommended in meter
(m) and can be determined using the form ula in the corresponding transmitter frequency column, where P is provided by the transmitter
manufacturer. The maximum output power rating of the transmitter in watts (W).
Note 1: Formulas for higher frequency range at 80MHz and 800MHz.
Note 2: These guidelines may not be suitable for all situations. Electromagnetic propagation is affected by the absorption and reflection
of buildings, objects and human bodies.
R egistrant/A fter-sales service unit/M anufacturer: Cofoe Medical Technology Co., Ltd.
Registered address: No. 816, Zhenhua Road, Yuhua District, Changsha City, Hunan Province, China
Tel: 400-888-6170
E-m ail: sincom yl@ 163.com
Production date: Refer to the outer package
Date of expiry: 5 years
The company reserves the right to make product improvements and is subject to change without notice.

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