Kinetik Wellbeing WBP1 Instruction manual

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By cmlam at 4:46 pm, Oct 29, 2019

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Blood Pressure Monitor

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Instruction Manual

WBP1

TABLE OF CONTENTS

INTRODUCTION.......................................................................2 - 8

Support
General Description
Indications for Use
Contraindications
Measurement Principle
Safety Information
LCD Display Signal
Monitor Components
List

BEFORE YOU START..................................................................9 - 12

Power Supply
Installing and Replacing the Batteries
Setting Date, Time
Select the user

TAKING A MEASUREMENT...........................................................13 - 14

Fitting the Cuff
Start the Measurement

DATA MANAGEMENT.................................................................15 -16

Check the memory
Delete the Readings

INFORMATION FOR USER............................................................17

Tips for measurement
Maintenance

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ABOUT BLOOD PRESSURE...........................................................18 - 19

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..................................................................20

SPECIFICATIONS......................................................................21

MANUFACTURER INFORMATION / RETURN POLICY............................22

COMPLIED STANDARDS LIST........................................................23

EMC GUIDANCE.........................................................................24 - 26

1

INTRODUCTIONINTRODUCTION

Support

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:

[e-mail]

Post:

Kinetik Medical Devices Limited
Unit 3, Perrywood Business Park, Honeycrock Lane,
Salfords, Redhill. RH1 5DZ

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General Description

Thank you for selecting Kinetik arm type blood pressure monitor (WBP1).
The monitor features blood pressure measurement, pulse rate measurement
and the result storage.
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.

Features:
65mm×50mm Digital LCD display

90 readings
3rd Generation Technology: Measuring during inflation

Indications for Use

The Kinetik Blood Pressure Monitor is digital monitors intended for use in
measuring blood pressure and heartbeat rate with arm circumference
22cm to 42cm (about 8¾˝-16½˝).

It is intended for adult indoor use only.

Contraindications

1. The device is not suitable for use on may be pregnant women or pregnant
women.

2. The device is not suitable for use on patients with implanted, electrical
devices, such as cardiac pacemakers, defibrillators.

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 air 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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2 3

INTRODUCTIONINTRODUCTION

Safety Information

The signs below might be in the user manual, labeling or other component.

They are the requirement of standard and using.

Read the instructions (actual
symbol colours are white on a

blue background).

This product complies with

0197

MDD93/42/EEC requirements.

Symbol for “MANUFACTURER”

SN

Symbol for “SERIAL NUMBER”

Symbol for “DIRECT CURRENT”

Symbol for “MANUFACTURE
DATE”

Classification for water ingress
and particulate matter

Symbol for “TYPE BF APPLIED
PARTS”

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”

Symbol for “Authorised Representative

EC REP

in the European Community”

Caution: These notes must be
observed to prevent any damage
to the device.

CAUTION

* This device is intended for adult use in homes only.
* The device is not suitable for use on neonatal patients, pregnant women,patients with implanted,
electronical devices, patients with pre-eclampsia, premature ventricular beats, atrial fibrillation,
peripheral, arterial disease and patients undergoing intravascular therapy or arterio-venous shunt or
people who received a mastectomy. Please consult your doctor prior to using the unit if you suffer from
illnesses.
* The device is not suitable for measuring the blood pressure of children. Ask your doctor before using it
on older children.
* The device is not intended for patient transport outside a healthcare facility.
* The device is not intended for public use.
* 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 functions other than obtaining a blood pressure
measurement.
* Do not confuse self-monitoring with self-diagnosis. This unit allows you to monitor your blood
pressure.Do not begin or end medical treatment without asking a physician for treatment advice.
* If you are taking medication,consult your physician to determine the most appropriate time to measure
your blood pressure. Never change a prescribed medication without consulting your physician.

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CAUTION

* Do not take any therapeutic measures on the basis of a self measurement. Never alter the dose of a
medicine prescribed by a doctor. Consult your doctor if you have any question about your blood pressure.
* When the device was used to measure patients who have common arrhythmias such as atrial or
ventricular premature beats or atrial fibrillation, the best result may occur with deviation. Please consult
your physician about the result.
* Don't kink the connection tube during use, otherwise, the cuff pressure may continuously increase which
can prevent blood flow and result in harmful injury to the PATIENT.
* When using this device, please pay attention to the following situation which may interrupt blood flow and
influence blood circulation of the patient, thus cause harmful injury to the patient: connection tubing kinking
too frequent and consecutive multiple measurements; the application of the cuff and its pressurization on
any arm where intravascular access or therapy, or an arterio-venous (A-V) shunt, is present; inflating the
cuff on the side of a mastectomy.
* Warning: Do not apply the cuff over a wound;otherwise it can cause further injury.
*Do not inflate the cuff on the same limb which other monitoring ME equipment is applied around
simultaneously, because this could cause temporary loss of function of those simultaneously-used
monitoring ME equipment.
*On the rare occasion of a fault causing the cuff to remain fully inflated 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.
*Please check that operation of the device does not result in prolonged impairment of patient blood
circulation.
* When measurement, please avoid compression or restriction of the connection tubing.
* The device cannot be used with HF surgical equipment at the same time.
* The ACCOMPANYING DOCUMENT shall disclose that the SPHYGMOMANOMETER was clinically
investigated according to the requirements of ISO 81060-2:2013.
* To verify the calibration of the AUTOMATED SPHYGMOMANOMETER, please contact the manufacturer.
* This device is contraindicated for any female who may be suspected of, or is pregnant. Besides providing
inaccurate readings, the effects of this device on the fetus are unknown.
* Too frequent and consecutive measurements could cause disturbances in blood circulation and injuries.
* This unit is not suitable for continuous monitoring during medical emergencies or operations.Otherwise,
the patient’s arm and fingers will become anaesthetic, swollen and even purple due to a lack of blood.
* When not in use, store the device in a dry room and protect it against extreme moisture, heat, lint, dust
and direct sunlight. Never place any heavy objects on the storage case.
* This device may be used only for the purpose described in this booklet. The manufacturer cannot be held
liable for damage caused by incorrect application.
*This device comprises sensitive components and must be treated with caution. Observe the storage and
operating conditions described in this booklet.
* The equipment is not AP/APG equipment and not suitable for use in the presence of a flammable
anesthetic mixture with air of with oxygen or nitrous oxide.
* Warning: No servicing/maintenance while the ME equipment is in use.
* The patient is an intended operator.
* The patient can measure data and change battery under normal circumstances and maintain the device
and its accessories according to the user manual.
* To avoid measurement errors, please avoid the condition of strong electromagnetic field radiated
interference signal or electrical fast transient/burst signal.
* The blood pressure monitor and the cuff are suitable for use within the patient environment. If
you are allergic to polyester, nylon or plastic, please don't use this device.
* During use, the patient will be in contact with the cuff. The materials of the cuff have been tested and
found to comply with requirements of ISO 10993-5:2009 and ISO 10993-10:2010. It will not cause any
potential sensization or irritation reaction.

4 5

INTRODUCTIONINTRODUCTION

CAUTION

* If you experience discomfort during a measurement, such as pain in the arm or other complaints, press
the START/STOP button to release the air immediately from the cuff. Loosen the cuff and remove it from
your arm.
* If the cuff pressure reaches 40 kPa (300 mmHg), the unit will automatically deflate. Should the cuff not
deflate when pressures reaches 40 kPa (300 mmHg), detach the cuff from the arm and press the
START/STOP button to stop inflation.
* Before use, make sure the device functions safely and is in proper working condition. Check the device,
do not use the device if it is damaged in any way. The continuous use of a damaged unit may cause
injury, improper results, or serious danger.
* 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.
* It is recommended that the performance should be checked every 2 years and after maintenance and
repair, by retesting at least the requirements in limits of the error of the cuff pressure indication and air
leakage (testing at least at 50mmHg and 200mmHg).
* Please dispose of ACCESSORIES, detachable parts, and the ME EQUIPMENT according to the local
guidelines.
* Manufacturer will make available on request circuit diagrams, component part lists, descriptions,
calibration instructions,etc., to assist to service personnel in parts repair.
* The operator shall not touch output of batteries and the patient simultaneously.
* Cleaning :Dust environment 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.
* The device doesn’t need to be calibrated within two years of reliable service.
* If you have any problems with this device, such as setting up, maintaining or using, please contact the
SERVICE PERSONNEL of Harvard Medical Devices. 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 report to Harvard Medical Devices if any unexpected operation or events occur.
* Keep the unit out of reach of infants, young children or pets to avoid inhalation or swallowing of small
parts. It is dangerous or even fatal.
* Be careful to strangulation due to cables and hoses, particularly due to excessive length.
* At least 30 min required for ME equipment to warm from the minimum storage temperature between
uses until it is ready for intended use. At least 30 min required for ME equipment to cool from the
maximum storage temperature between uses until it is ready for intended use.
* This equipment needs to be installed and put into service in accordance with the information provided in
the ACCOMPANYING DOCUMENTS;
* Wireless communications equipment such as wireless home network devices, mobile phones, cordless
telephones and their base stations, walkie-talkies can affect this equipment and should be kept at least a
distance d away from the equipment. The distance d is calculated by the MANUFACTURER from the 80
MHz to 5.8 GHz column of Table 4 and Table 9 of IEC 60601-1-2:2014, as appropriate.
* Please use ACCESSORIES and detachable partes specified/ authorised by MANUFACTURE.
Otherwise, it may cause damage to the unit or danger to the user/patients.
* There is no luer lock connectors are used in the construction of tubing, there is a possibility that they
might be inadvertently connected to intravascular fluid systems, allowing air to be pumped into a blood
vessel.
* Please use the device under the environment which was provided in the user manual. Otherwise, the
performance and lifetime of the device will be impacted and reduced.

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LCD display signal

SYMBOL DESCRIPTION

Systolic pressure High blood pressure

Diastolic pressure Low blood pressure

mmHg

Blood pressure
level indicator

Low battery

Irregular heartbeat

Current Time Year/Month/Day, Hour : Minute

Heartbeat

Average value

mmHg

mmHg

/mi n

EXPLANATION

Pulse in beats per minutePulse display

Measurement Unit of the blood pressure

(1mmHg=0.133kPa)

Indicate the blood pressure level

Batteries are low and need to be replaced

Blood pressure monitor is detecting an
irregular heartbeat during measurement.

Blood pressure monitor is detecting a
heartbeat during measurement.

The average value of blood pressure

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76

INTRODUCTION BEFORE YOU START

Monitor Components Power Supply

1 Battery powered mode:

CUFF

AIR HOSE

AIR CONNECTOR PLUG

Component list of
pressure measuring system

1. Cuff

2. Air pipe

3. PCBA

4. Pump

5. Valve

6VDC 4×AAA batteries

CAUTION

In order to get the best effect and protect your monitor,please use the right

battery.

Installing and Replacing the Batteries

START/STOP BUTTON

MEMORY BUTTON

LCD DISPLAY

BATTERY COMPARTMENT

List

1. Blood Pressure Monitor
(WBP1)

3. 4×AAA batteries

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2. Cuff (Type BF applied part)

4. User manual

(22cm~42cm)

(Please use Kinetik
authorized cuff. The size
of the actual cuff please
refer to the label on the

attached cuff.)

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• Open the battery cover.

• Install the batteries by matching

the correct polarity, as shown.

• Replace the battery cover.

Replace the batteries whenever the below happens

The shows

The display is dim

The display does not light up.

CAUTION

Do not use new and used batteries together.
Do not use different types of batteries together.
Do not dispose the batteries in fire. Batteries may explode or leak.
Remove batteries if the device is not likely to be used for some time.
Worn batteries are harmful to the environment. Do not dispose with daily garbage.
Remove the old batteries from the device following your local recycling guidelines.

98

BEFORE YOU START BEFORE YOU START

Setting Date and Time.

It is important to set the clock before using your blood pressure
monitor, so that a time stamp can be assigned to each reading that is
stored in the memory. (The setting range of the year :2017—2057;
Time format:24H)

1. When the monitor is off, hold pressing “ ”

for 3 seconds to enter the mode for year setting.

mmHg

mmHg

/min

2. Press “ ” button to change

the [YEAR]. Each press will
increase the numeral by one in a
cycling manner.

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mmHg

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mmHg

/min

3. Press “ ” button to confirm [YEAR]. Then the monitor

diverts to [MONTH] and [DAY] setting.

mmHg

mmHg

/min

4. Repeat steps 2 and 3 to set the [MONTH] and [DAY].

mmHg

mmHg

/min

mmHg

mmHg

/min

Power Supply

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1110

BEFORE YOU START TAKING A MEASUREMENT

5. Repeat steps 2 and 3 to set the [HOUR] and [MINUTE].

mmHg

mmHg

/min

6. After hour and minute are set, the LCD will display “donE”

and the monitor will turn off.

mmHg

mmHg

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/min

Fitting the cuff

mmHg

mmHg

/min

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1. Remove all Jewellery, such as watches and
bracelets from your left arm.
Note: If your doctor has diagnosed you with
poor circulation in your left arm, use your right arm.

2. Roll or push up your sleeve to expose the skin.
Make sure your sleeve is not too tight.

3. Hold your arm with your palm facing up and tie the
cuff on your upper arm, then position the tube off-center

toward the inner side of arm in line with the little finger.
Or position the artery mark over the main artery (on

the inside of your arm). Note: Locate the main artery

by pressing with 2 fingers approximately 2 cm
above the bend of your elbow on the inside
of your left arm. Identify where the pulse can be
felt the strongest. This is your main artery.

4. The cuff should be snug but not too tight. You
should be able to insert one finger between the cuff
and your arm.

5. Sit comfortably with your tested 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.

6. Helpful tips for Patients, especially for Patients with Hypertension:

Rest for 5 minutes before first measuring.
Wait at least 3 minutes between measurements. This allows your blood circulation
to recover.
Take the measurement in a silent room.
The patient must relax as much as possible and do not move and talk during the
measurement procedure.
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.
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 physician.

2~3cm

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1312

TAKING A MEASUREMENT DATA MANAGEMENT

Check the memoryStart the Measurement

When the monitor is off, press “ ” button to turn on the

1.

monitor, and it will finish the whole measurement.

LCD display

mmHg

Adjust the zero.

mmHg

1.

When the monitor is off, please press “ ” button to show the
average value of the latest three records.If the records are
less than 3 groups, it will display the latest record instead.

mmHg

mmHg

/min

Inflating and measuring.

mmHg

mmHg

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/min

mmHg

/min

Display and save the
measurement result.

mmHg

mmHg

/min

Press the “ ” to get the record you want.

2.

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mmHg

/min

mmHg

mmHg

/min

The date and time
of the record
will be shown

2. Press the “ ” to power

off, otherwise it will turn off

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within 1 minute.

alternately.

The current No. is No 1.
Five records in total.

The corresponding
date is January 1st

2017.

The corresponding
time is 6:00.

1514

INFORMATION FOR USERDATA MANAGEMENT

Delete the Readings Tips for Measurement

If you did not get the correct measurement, you can delete all
results for the selected user by following steps below.

Hold pressing “ M ” button

1.

for 3 seconds when the
monitor is in the memory

recall mode, the flash

display “dEL ALL” will
show.

Hold Press “ ”

2.

button to confirm deleting and

the monitor will turn off.

Note: To exit out of delete mode
without deleting any records,
press “ ” button.

mmHg

mmHg

/min

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3.

If there is no record,
press “M” button,
the right display will
show.

mmHg

敬请留意。

mmHg

/min

Measurements may be inaccurate if taken in the following
circumstances.

1. Within 1 hour after drinking or eating.

2. Immediate measurement after tea, coffee or smoking

3. Within 20 minutes after taking a bath

4. When talking or moving your fingers

5. In a very cold Environment

6. When you need the bathroom

Maintenance

In order to get the best performance, please follow the
instructions below.

1. Put in a dry place and avoid the sunlight

2. Avoid contact with water, clean it with a dry cloth in case.

3. Avoid intense shaking and collisions

4. Avoid dusty and unstable temperature environment

5. Use wet cloths to remove dirt

6. Do not attempt to clean the reusable cuff with water and
never immerse the cuff in water.

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16

17

ABOUT BLOOD PRESSUREABOUT BLOOD PRESSURE

What are systolic pressure and diastolic pressure?

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.

Systolic

blood discharging

artery

press

Diastolic

blood entering
vein

relax

What is the standard blood pressure classification?

The blood pressure classification published

by World Health Organization (WHO) and
International Society of Hypertension (ISH)

in 1999 is as follows:

CAUTION

Only a physician can tell your normal BP
range. Please contact a physician if your
measuring result falls out of the range.
Please note that only a physician can tell
whether your blood pressure value has
reached a dangerous point.

Level

Blood
Pressure (mm Hg)

SYS

DIA

Irregular Heartbeat Detector

An irregular heartbeat is detected when a heartbeat 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
four or more pulse intervals, the difference between each interval and the average is more than
the average value of ±15%,the irregular heartbeat symbol appears on the display when the
measurement results are appeared.

The appearance of the IHB icon indicates that a pulse irregularity consistent with an
irregular heart-beat was detected during measurement. Usually this is NOT a cause
for concern. However, if the symbol appears often, we recommend you seek medical

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advice. Please note that the device does not replace a cardiac examination, but
serves to detect pulse irregularities at an early stage.

Optimal Normal High-normal Mild Moderate Severe

130-139

<120

<80

120-129

80-84

85-89

140-159

90-99

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CAUTION

160-179

100-109

±25% , or there are

≥180

≥110

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Why does my blood pressure

fluctuate throughout the day?

1. Individual blood pressure varies
multiple times everyday. It is also affected
by the way you wear your cuff and your
measurement position, so please take the
measurement under the same conditions.

2. If the person takes medicine, the

pressure will vary more.

3. Wait at least 3 minutes for another

measurement.

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 the
“white coat” effect, which means blood
pressure usually increases in clinical
settings.

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

It is ok for both arms, but there
will be some different results for
different people. We suggest you
measure the same arm every time.

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

If the cuff is tied properly.
If the cuff is too tight or too loose.
If the cuff is tied on the upper arm.
If you feel anxious.
Taking 2-3 deep breaths before

beginning will be better for measuring.

Advice: Relax yourself for 4-5

minutes until you calm down.

1918

SPECIFICATIONSTROUBLE SHOOTING

This section includes a list of error messages and frequently
asked questions for problems you may encounter with your blood
pressure monitor. If the product is not operating as you think it
should, check here before arranging for servicing.

PROBLEM SYMPTOM CHECK THIS REMEDY

No power

Low
batteries

Error

Display will not

light up.

Display is dim or
show

E 01 shows

E 02 shows

E 03 shows

message

E 04 shows

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EExx, shows on
the display.

Warning
message

“out ” shows

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Batteries are exhausted. Replace with new batteries

Batteries are inserted
incorrectly.

Batteries are low.

The cuff is too tight
or too loose.

The monitor
detected motion
while measuring.

The measurement
process does not
detect the pulse
signal.

The treatment of the
measurement failed.

A calibration error
occurred. (XX can
be some digital symbol,
such as 01, 02,etc., if
this similar situation
appears, it is a
calibration error.)

Out of measurement
range

Insert the batteries

correctly

Replace with new batteries

Refasten the cuff and then
measure again.

Movement can affect the
measurement.Relax for a
moment and then
measure again.

Loosen the clothing on
the arm and then
measure again.

Relax for a moment and
then measure again.

Retake the measurement.
If the problem persists,
contact the retailer or our
customer service
department for further
assistance.Refer to the
warranty for contact
information and return
instructions.

Relax for a moment.
Refasten the cuff and then
measure again. If the
problem persists, contact
your physician.

敬请留意。

Power supply

Display mode

Measurement mode

Measurement range

Accuracy

Normal working condition

Storage & transportation

condition

Measurement perimeter

of the upper arm

Weight

External dimensions

Attachment

Mode of operation

Degree of protection

Protection against

ingress of water

Device Classification

Software Version A04

WARNING: No modification of this equipment is allowed.

Battery powered mode:
6VDC 4×AAA batteries

Digital LCD display V.A.65mm×50mm

Oscillographic testing mode

Rated cuff pressure:
0mmHg~299mmHg
Measurement pressure:
SYS: 60mmHg~230mmHg
DIA: 40mmHg~130mmHg
Pulse value: 40-199 beats/minute

Pressure:
5°C - 40°C within±3mmHg(0.4kPa)
Pulse value:

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

Temperature:-20°C to +60°C
A relative humidity range of ≤ 93%, non-condensing,
at a water vapour pressure up to 50hPa

22cm~42cm

Approx.225g(Excluding the dry cells and cuff)

Approx.120.2mm×108.2mm×68.5mm

4×AAA batteries, user manual

Continuous operation

Type BF applied part

IP21 It means the device could protected against
solid foreign objects of 12.5mm and greater, and
protect against vertically falling water drops.

Battery Powered Mode:
Internally Powered ME Equipment

±5%

2120

MANUFACTURER INFORMATION COMPLIED STANDARDS LIST AND EMC GUIDANCE

Manufacturer Information Complied Standards List

Manufactured by:
Company:
Address:

Authorized European Representative:
Company:
Address:

RETURN POLICY

Product may be returned if faulty, please contact the Retailer or
Kinetik directly if you're experiencing issues with your product.
This does not affect your statutory rights. Please note the retailer's
own return policy may still be valid, contact the retailer for more
information.

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Harvard Medical Devices Ltd. HK

Harvard Medical Devices Ltd. HK

1002, Railway Plaza, TST, HK

Share Info Consultant Service LLC Repräsentanzbüro

Heerdter Lohweg 83, 40549 Düsseldorf

Risk management

Labeling

User manual

General Requirements
for Safety

Electromagnetic
compatibility

Performance
requirements

Clinical investigation

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Usability

Software life-cycle
processes

Bio-compatibility

EN ISO 14971:2012 / ISO 14971:2007 Medical devices ­Application of risk management to medical devices

EN ISO 15223-1:2016 / ISO 15223-1:2016 Medical devices.
Symbols to be used with medical device labels, labelling and
information to be supplied. Part 1 : General requirements

EN 1041:2008+A1:2013 Information supplied by the manufacturer of
medical devices

EN 60601-1:2006+A1:2013/ IEC 60601-1:2005+A1:2012 Medical
electrical equipment - Part 1: General requirements for basic safety and
essential performance
EN 60601-1-11:2015/ IEC 60601-1-11:2015 Medical electrical
equipment - Part 1-11: General requirements for basic safety and
essential performance - Collateral standard: Requirements for medical
electrical equipment and medical electrical systems used in the home
healthcare environment

EN 60601-1-2:2015/ IEC 60601-1-2:2014 Medical electrical
equipment - Part 1-2: General requirements for basic safety and
essential performance - Collateral standard: Electromagnetic
compatibility - Requirements and tests

EN ISO 81060-1:2012 Non-invasive sphygmomanometers - Part 1:
Requirements and test methods for non-automated measurement type

EN 1060-3:1997+A2:2009 Non-invasive sphygmomanometers ­Part 3: Supplementary requirements for electro-mechanical blood
pressure measuring systems
IEC 80601-2-30:2009+A1:2013 Medical electrical equipment- Part 2-30:
Particular requirements for the basic safety and essential performance of
automated non-invasive sphygmomanometers

EN 1060-4:2004 Non-invasive sphygmomanometers - Part 4: Test
procedures to determine the overall system accuracy of automated
non-invasive sphygmomanometers

ISO 81060-2:2013 Non-invasive sphygmomanometers - Part 2:
Clinical validation of automated measurement type

EN 60601-1-6:2010+A1:2015/IEC 60601-1-6:2010+A1:2013
Medical electrical equipment - Part 1-6: General requirements for basic
safety and essential performance - Collateral standard: Usability

IEC 62366-1:2015 Medical devices - Part 1: Application of usability
engineering to medical devices

EN 62304:2006/AC: 2008 / IEC 62304: 2006+A1:2015 Medical device

software - Software life-cycle processes

ISO 10993-1:2009 Biological evaluation of medical devices- Part

1: Evaluation and testing within a risk management process

ISO 10993-5:2009 Biological evaluation of medical devices -

Part 5: Tests for in vitro cytotoxicity

ISO 10993-10:2010 Biological evaluation of medical devices -

Part 10: Tests for irritation and skin sensitization

2322

COMPLIED STANDARDS LIST AND EMC GUIDANCE COMPLIED STANDARDS LIST AND EMC GUIDANCE

EMC Guidance

The ME EQUIPMENT or ME SYSTEM is suitable for home healthcare environments

Warning: Don’t near 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 WBP1, including cables specified by the manufacturer. Otherwise,
degradation of the performance of this equipment could result.

Table 2

Guidance and manufacturer’s declaration – electromagnetic Immunity

Immunity Test

Electrostatic
discharge (ESD)
IEC 61000-4-2

Electrical fast
transient/burst
IEC 61000-4-4

Surge
IEC61000-4-5

IEC 60601-1-2 Test level

±8 kV contact
±2 kV, ±4kV, ±8 kV, ±15 kV air

Not application Not application

Not application Not application

Compliance level

±8 kV contact

±2 kV, ±4kV, ±8 kV,
±15 kV air

Technical description:

1. all necessary instructions for maintaining BASIC SAFETY and ESSENTIAL PERFOR­MANCE with regard to electromagnetic disturbances for the excepted service life.

2. Guidance and manufacturer’s declaration-electromagnetic emissions and Immunity

Table 1

Guidance and manufacturer’s declaration - electromagnetic emissions

Emissions test

RF emissions
CISPR I I

RF emissions
CISPR I I

Harmonic emissions
IEC 61000-3-2

Voltage fluctuations/
flicker emissions
IEC 61000-3-3

PDF文档只供参考，不可用于印刷，

请用AI或EPS档案印刷。

Compliance

Group I

Class B

Not application

Not application

敬请留意。

Voltage dips, short
interruptions and
voltage variations
on power supply
input lines
IEC 61000-4-11

Power frequency
magnetic field
IEC 61000-4-8

Conduced RF
IEC61000-4-6

Radiated RF
IEC61000-4-3

T

NOTE U

Not application Not application

30 A/m
50Hz/60Hz

Not application Not application

10 V/m
80 MHz – 2,7 GHz
80 % AM at 1 kHz

is the a.c. mains voltage prior to applicatio n of the test level.

30 A/m
50Hz/60Hz

10 V/m
80 MHz – 2,7 GHz
80 % AM at 1 kHz

24 25

COMPLIED STANDARDS LIST AND EMC GUIDANCE

Table 3

Guidance and manufacturer’s declaration - electromagnetic Immunity

Test

Band

Radiated RF
IEC61000-4-3
(Test
specifications
for
ENCLOSURE
PORT
IMMUNITY to
RF wireless
communica­tions

equipment)

Frequency
(MHz)

385 0.3 27

450 430-

710 704­745
780

810

870

930

1720

1845

1970

5240

5500

5785

Service Modulation Modulation

(MHz)

380-

TETRA

390

400

GMRS 460,

470

FRS 460

LTE Band
13,

787

17

800-

GSM

960

800/900,
TETRA 800,
iDEN 820,
CDMA 850,
LTE Band 5

1700-

GSM 1800;

1990

CDMA 1900;
GSM 1900;
DECT;
LTE Band 1,
3,
4,25; UMTS

Bluetooth,

2570

WLAN,

802.11
b/g/n, RFID
2450, LTE

请用AI或EPS档案印刷。

Band 7

5100-

WLAN

5800

802.11
a/n

Pulse

modulation b)

18Hz

FM c) ± 5kHz
deviation 1kHz
sine

Pulse

modulation b)

217Hz

Pulse

modulation b)

18Hz

Pulse

modulation b)

217Hz

Pulse
modulation
217 Hz

Pulse
modulation
217 Hz

Distance (m)

(W)

1.8

2 0.3 28

0.2 0.3 9

2 0.3 28

2 0.3 28

2 0.3 282450 2400-

0.2 0.3 9

Manufactured by Harvard Medical Devices Ltd. HK

Share Info Consultant Service LLC Repräsentanzbüro

IMMUNITY
TEST
LEVEL
(V/m)

Heerdter Lohweg 83, 40549 Düsseldorf

Harvard Medical Devices Ltd. HK
1002, Railway Plaza, TST, HK

敬请留意。

Made in China

PDF文档只供参考，不可用于印刷，

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Kinetik WBP1 EN IB 20191004