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

档

案印刷。

请

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档 敬

Blood Pressure Monitor

PDF文

Instruction Manual

WBP1

TABLE OF CONTENTS

INTRODUCTION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

2 - 8

Support

General Description

Indications for Use

Contraindications

Measurement Principle

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Safety Information

LCD Display Signal

List

案印刷。

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

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DATA MANAGEMENT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

15 -16

Check the memory

Delete the Readings 留意。

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

17

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?

PDF文 TROUBLESHOOTING . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

20

SPECIFICATIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

21

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

22

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

23

EMC GUIDANCE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

24 - 26

1

INTRODUCTION INTRODUCTION

2

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).

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.

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Features: 案印刷。

Indications for Use

We promise to respond to all queries and will ensure to resolve any issue you may be having.

You can reach us by…

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 8 ¾ ˝-16 ½ ˝).

It is intended for adult indoor use only.

Phone:

+44 1483 937969

Live Chat:

Simply visit www.kinetikwellbeing.com and send us a message.

Email:

Post:

请

Kinetik Medical Devices Limited

Salfords, Redhill. RH1 5DZ

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请

Contraindications

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

留意。

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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3

INTRODUCTION INTRODUCTION

4

CAUTION

Safety Information

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

They are the requirement of standard and using.

0197

SN

Read the instructions (actual symbol colours are white on a blue background).

This product complies with

MDD93/42/EEC requirements.

Symbol for “MANUFACTURER”

Symbol for “SERIAL NUMBER”

Symbol for “DIRECT CURRENT”

Symbol for “MANUFACTURE

DATE”

Classification for water ingress and particulate matter

CAUTION

EC REP

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 in the European Community”

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

* 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, 请

用AI或EPS 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

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档 敬 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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* 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

案印刷。 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.

5

INTRODUCTION INTRODUCTION

6

CAUTION

LCD display signal

* 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

请

* 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.

PDF文

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Systolic pressure

Diastolic pressure

Pulse display mmHg mmHg

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案印刷。 mmHg

/min

SYMBOL DESCRIPTION EXPLANATION

Low battery

Irregular heartbeat

Current Time

Batteries are low and need to be replaced

Blood pressure monitor is detecting an irregular heartbeat during measurement.

Year/Month/Day, Hour : Minute

Heartbeat

Average value

High blood pressure

Low blood pressure

Pulse in beats per minute

Measurement Unit of the blood pressure

(1mmHg=0.133kPa)

Indicate the blood pressure level

Blood pressure monitor is detecting a heartbeat during measurement.

The average value of blood pressure

7

INTRODUCTION

Monitor Components

CUFF

AIR HOSE

AIR CONNECTOR PLUG

BEFORE YOU START

Power Supply

1 Battery powered mode:

6VDC 4 × AAA batteries

Component list of pressure measuring system

1. Cuff

2. Air pipe

3. PCBA

4. Pump

5. Valve

START/STOP BUTTON

CAUTION

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

案印刷。

Installing and Replacing the Batteries

• Open the battery cover.

• Install the batteries by matching the correct polarity, as shown.

• Replace the battery cover.

MEMORY BUTTON

LCD DISPLAY

8

List

(WBP1)

请

1. Blood Pressure Monitor

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3. 4 ×

PDF文

4. User manual

只供参考，不可用于印刷，

(22cm~42cm)

(Please use Kinetik authorized cuff. The size

请

The shows

The display is dim

The display does not light up.

of the actual cuff please refer to the label on the attached cuff.)

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.

9

BEFORE YOU START BEFORE YOU START

10

3. Press “ ” button to confirm [YEAR]. Then the monitor diverts to [MONTH] and [DAY] setting.

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) mmHg mmHg

1. When the monitor is off, hold pressing “ ” for 3 seconds to enter the mode for year setting. mmHg

档 mmHg

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

/min mmHg cycling manner.

请

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敬

留意。 mmHg

/min mmHg

/min

Power Supply

PDF文 /min mmHg

11

BEFORE YOU START TAKING A MEASUREMENT

12

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

Fitting the cuff

mmHg mmHg mmHg

/min

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

请

档 /min mmHg

/min

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.

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Make sure your sleeve is not too tight.

3.

Hold your arm with your palm facing up and tie the cuff 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.

2~3cm

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.

敬

请

6.

Helpful tips for Patients, especially for Patients with Hypertension:

Rest for 5 minutes before first measuring.

留意。

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.

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13

TAKING A MEASUREMENT

Start the Measurement

1.

When the monitor is off, press “ ” button to turn on the monitor, and it will finish the whole measurement.

LCD display Adjust the zero.

mmHg mmHg mmHg

/min mmHg

/min

Inflating and measuring.

mmHg 请

/min

档

Display and save the measurement result.

14 off, otherwise it will turn off within 1 minute.

/min

DATA MANAGEMENT

Check the memory

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

档

/min

2.

Press the “ ” to get the record you want. mmHg mmHg

/min

The date and time of the record will be shown alternately.

The current No. is No 1.

Five records in total.

The corresponding date is January 1st

2017.

The corresponding time is 6:00.

15

DATA MANAGEMENT

Delete the Readings

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

1.

Hold pressing “ M ” button for 3 seconds when the monitor is in the memory recall mode, the flash display “dEL ALL” will show.

2.

Hold Press “ ” button to confirm deleting and the monitor will turn off. mmHg mmHg

/min

INFORMATION FOR USER

Tips for Measurement

Measurements may be inaccurate if taken in the following circumstances.

1. Within 1 hour after drinking or eating.

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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

16

3.

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

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

请

用AI或EPS

档 show. mmHg

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/min

Maintenance

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

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.

17

ABOUT BLOOD PRESSURE ABOUT 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.

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.

Systolic

blood discharging artery press

Diastolic

blood entering vein relax

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

档 measurement position, so please take the measurement under the same conditions.

案印刷。 measurement.

Why do I get a different blood pressure at home

What you need to pay attention to when you measure

compared to the hospital?

your blood pressure at home:

18

The blood pressure is different even throughout the day due to weather,

It is ok for both arms, but there

If the cuff is too tight or too loose.

Level

Blood

Pressure (mm Hg)

Optimal Normal High-normal Mild Moderate Severe

DIA <80 80-84

请

85-89 90-99 100-109 ≥110

敬 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 heartbeat symbol appears on the display when the

请

If the cuff is tied on the upper arm.

SYS <120 120-129 140-159 160-179 ≥180 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 emotion, exercise etc, Also, there is the

“white coat” effect, which means blood 留意。

Is the result the same if measuring on the right 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.

只供参考，不可用于印刷， will be some different results for different people. We suggest you measurement results are appeared.

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

measure the same arm every time.

If the cuff is tied properly.

19

TROUBLE SHOOTING SPECIFICATIONS

20

Battery powered mode:

6VDC 4 × AAA batteries

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.

Power supply

Display mode Digital LCD display V.A.65mm

× 50mm

Low batteries

Error message

Display will not light up.

Batteries are inserted incorrectly.

Display is dim or show

Batteries are low.

Insert the batteries correctly

Measurement mode

Oscillographic testing mode

PROBLEM SYMPTOM CHECK THIS

No power message

E 01 shows

E 02 shows

The cuff is too tight or too loose.

The monitor detected motion while measuring.

REMEDY

Batteries are exhausted. Replace with new batteries

Replace with new batteries

Refasten the cuff and then measure again.

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

档

Measurement range 案印刷。

Accuracy

Rated cuff pressure:

0mmHg~299mmHg

Measurement pressure:

SYS: 60mmHg~230mmHg

Pressure:

5°C - 40°C within±3mmHg(0.4kPa)

Pulse value: ± 5%

A temperature range of :+5°C to +40°C

Normal working condition

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

E 03 shows Storage & transportation

敬 assistance.Refer to the warranty for contact

请 condition

A relative humidity range of ≤ 93%, non-condensing, at a water vapour pressure up to 50hPa

E 04 shows

请

EExx, shows on the display.

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

Retake the measurement.

If the problem persists, contact the retailer or our customer service department for further of the upper arm

Attachment

Mode of operation

22cm~42cm

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

Approx.120.2mm

× 108.2mm

× 68.5mm

4 × AAA batteries, user manual

Continuous operation appears, it is a calibration error.)

Degree of protection Type BF applied part information and return

Temperature:-20°C to +60°C

Protection against

IP21 It means the device could protected against instructions.

solid foreign objects of 12.5mm and greater, and

Relax for a moment.

ingress of water

Refasten the cuff and then protect against vertically falling water drops.

“out ” shows

Out of measurement range measure again. If the

Battery Powered Mode: problem persists, contact

Device Classification

Internally Powered ME Equipment your physician.

Software Version

A04

WARNING: No modification of this equipment is allowed.

21

MANUFACTURER INFORMATION COMPLIED STANDARDS LIST AND EMC GUIDANCE

Manufacturer Information Complied Standards List

Manufactured by:

Company:

Address:

Harvard Medical Devices Ltd. HK

Harvard Medical Devices Ltd. HK

1002, Railway Plaza, TST, HK

Risk management

EN ISO 14971:2012 / ISO 14971:2007 Medical devices -

Application of risk management to medical devices

22

Labeling

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

Authorized European Representative:

Company: Share Info Consultant Service LLC Repräsentanzbüro

Address: Heerdter Lohweg 83, 40549 Düsseldorf

RETURN POLICY

User manual

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 essential performance 档 for Safety

Electromagnetic compatibility

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

Product may be returned if faulty, please contact the Retailer or

Performance

EN ISO 81060-1:2012 Non-invasive sphygmomanometers - Part 1:

Kinetik directly if you're experiencing issues with your product.

Requirements and test methods for non-automated measurement type requirements

EN 1060-3:1997+A2:2009 Non-invasive sphygmomanometers - This does not affect your statutory rights. Please note the retailer's

Software life-cycle processes

Part 3: Supplementary requirements for electro-mechanical blood pressure measuring systems

IEC 80601-2-30:2009+A1:2013 Medical electrical equipment- Part 2-30: own return policy may still be valid, contact the retailer for more information.

请

用AI或EPS

档 敬

请

留意。

Usability

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 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

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Bio-compatibility

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

23

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

24

Table 2

EMC Guidance

Guidance and manufacturer’s declaration – electromagnetic Immunity 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.

Immunity Test IEC 60601-1-2 Test level Compliance level

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.

Electrostatic ± 8 kV contact ± 8 kV contact

档 discharge (ESD)

IEC 61000-4-2 案印刷。 transient/burst

IEC 61000-4-4

Surge

IEC61000-4-5

± 2 kV, ± 4kV, ± 8 kV, ± 15 kV air

± 2 kV, ± 4kV, ± 8 kV,

± 15 kV air

Not application

Not application Not application

Technical description:

1. all necessary instructions for maintaining BASIC SAFETY and ESSENTIAL PERFOR-

MANCE with regard to electromagnetic disturbances for the excepted service life.

Not application Not application Voltage dips, short interruptions and

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

请

用AI或EPS

Compliance

Group I 档 magnetic field

IEC 61000-4-8

Conduced RF

IEC61000-4-6

50Hz/60Hz

Not application

50Hz/60Hz

Not application

Not application

敬 voltage variations on power supply input lines

IEC 61000-4-11

Power frequency

Radiated RF

IEC61000-4-3

10 V/m

80 MHz – 2,7 GHz

80 % AM at 1 kHz

30 A/m

10 V/m

80 MHz – 2,7 GHz

80 % AM at 1 kHz

NOTE U

T is the a.c. mains voltage prior to application of the test level.

flicker emissions

IEC 61000-3-3

Not application

25

Manufactured by Harvard Medical Devices Ltd. HK

COMPLIED STANDARDS LIST AND EMC GUIDANCE

Table 3

Guidance and manufacturer’s declaration - electromagnetic Immunity

Share Info Consultant Service LLC Repräsentanzbüro

Heerdter Lohweg 83, 40549 Düsseldorf

Radiated RF

IEC61000-4-3

(Test specifications for

ENCLOSURE

PORT

IMMUNITY to

RF wireless communications equipment)

Test

Frequency

(MHz)

385

450

710

745

780

810

Band

(MHz)

380-

390

430-

470

704-

787

800-

960

870

930

1720

1845

1970

2450

5240

5500

5785

Service

TETRA

400

GMRS 460,

FRS 460

LTE Band

13,

17

Modulation Modulation

(W)

Distance (m) IMMUNITY

TEST

LEVEL

(V/m)

1.8

0.3

27 Pulse modulation b)

18Hz

FM c) ± 5kHz deviation 1kHz sine

Pulse modulation b)

217Hz

2

0.2

0.3

0.3

28

9

2 0.3

28

Harvard Medical Devices Ltd. HK

1002, Railway Plaza, TST, HK

档

案印刷。

GSM

800/900,

TETRA 800, iDEN 820,

CDMA 850,

LTE Band 5

Pulse modulation b)

18Hz

1700-

1990

5100-

5800

2400-

2570

Pulse modulation b)

2 0.3

28 GSM 1800;

CDMA 1900;

802.11

a/n

GSM 1900;

DECT;

LTE Band 1,

3,

4,25; UMTS

Bluetooth,

WLAN, b/g/n, RFID

2450, LTE

Band 7

WLAN

217Hz

用AI或EPS

217 Hz modulation

217 Hz

0.3

28

敬

请

留意。

26

PDF文

0197

Made in China

Kinetik WBP1 EN IB 20191004