kinetik Blood Pressure Monitor WBP2 Instruction Manual

: June 6, 2024
: Kinetik

Kinetik

kinetik Blood Pressure Monitor WBP2

INTRODUCTION

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 (UK):
+44 1483 937967
Post (UK):
Kinetik Medical Devices Limited
Unit 3, Perrywood Business Park, Honeycrock Lane, Salfords, Redhill. RH1 5DZ

Phone (NZ):
(09) 801 0627
Post (NZ):
Kinetik Wellbeing NZ
44 John Brian Drive, 0794 Redvale, Albany, Auckland, NewZealand

Live Chat:
Simply visit www.kinetikwellbeing.com and send us a message.
Email:
customercare@kinetikwellbeing.com

General Description

Thank you for selecting Kinetik arm type blood pressure monitor (WBP2). The monitor features blood pressure measurement, pulse rate measurement and the result storage. The design provides you with three years warranty.
Readings taken by the WBP2 are equivalent to those obtained by a trained observer using the cuff and stethoscope auscultation method.
This manual contains important safety and care information, and provides step by step instructions for using the product.
Read the manual thoroughly before using the product.

Features:

80mm×58.5mm Digital LCD display
Maximum 90 records per each user
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 ranging from 22cm to 42cm.
It is intended for adult indoor use only.

Contraindications

The device should not be used by any person who may be suspected of, or is pregnant.
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 atmospheric pressure. Then it starts inflating the arm cuff, meanwhile, the unit detects pressure oscillations generated by beat-to-beat pulsatile, which is used to determine the systolic and diastolic pressure, and also pulse rate.

Safety Information

The signs below might be in the user manual, labeling or other component. They are the requirement of standard and using.

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.
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 with the adapter 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, its adaptor, 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.
Adaptor is specified as a part of ME EQUIPMENT.

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 plug/adapter plug pins insulates the device from the main supply. Do not position the device in a position where it is difficult to disconnect from the supply mains to safely terminate operation of ME equipment.
The operator shall not touch output of batteries /adapter 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 three years warranty.
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.

LCD display signal

LCD Display LCD Display 2

Monitor Components

Monitor components

Component list of pressure measuring system

1. Cuff
2. Air pipe
3. PCBA
4. Pump
5. Valve

List

Blood Pressure Monitor (WBP2)
Cuff (Type BF applied part)
Bag
User manual

BEFORE YOU START

The Choice of Power Supply

Battery powered mode:
6VDC 4×AA batteries
AC adaptor powered mode:
(Please only use the recommended AC adaptor model).
Please unplug the adaptor to depart from the using utility power.

In order to get the best effect and protect your monitor, please use the right battery and special power adaptor which complies with local safety standard.

Installing and Replacing the Batteries

BEFORE YOU START-2

Open the battery cover.
Install the batteries by matching the correct polarity, as shown.
Replace the battery cover.

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.

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 record that is stored in the memory. (The setting range of the year :2017—2057; Time format:24H)

When the monitor is off, hold pressing “ Start/Stop ” button for 3 seconds to enter the mode for the year setting.
Press “Button” to increase one year.
Press “MEM” button to decrease one year.
Press ” Start/Stop” button to conﬁrm [YEAR]. Then the monitor enter into [MONTH] and [DAY] setting.
Repeat steps 2 and 3 to set the [MONTH] and [DAY].
Repeat steps 2 and 3 to set the [HOUR] and [MINUTE].
After hour and minute is set, the LCD will display “donE” and then turn off.

Select the User ID

Before you start the measurement, please select the desired user ID ﬁrst.

When the blood pressure monitor is off, press “” button the user ID will be shown. Then press button to change the user ID between user 1 and user 2.
Conﬁrm the user ID by pressing the “ Button” to recall the records; or pressing the “ Start/Stop” button to start the measurement.

TAKING A MEASUREMENT

Tie the cuff

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.
Roll or push up your sleeve to expose the skin. Make sure your sleeve is not too tight.
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.
The cuff should be snug but not too tight. You should be able to insert one finger between the cuff and your arm.
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.
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.

Start the Measurement

When the monitor is off, press “Start/Stop” button to turn on the monitor, and it will ﬁnish the whole measurement.(Take user 1 for example.)
Press the “ Start/Stop” button to power off, otherwise it will turn off within 1 minute.

DATA MANAGEMENT

Recall the Records

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.
Press the “MEM” button to get the record you want.

Delete the Records

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

Hold pressing “MEM” button for 3 seconds when the monitor is in the memory recall mode, the display will show “dEL y”.
Press “ MEM ” or “ second” button to switch the display between “dEL n” or “dEL y”.
Press “ Start/Stop ” button to conﬁrm deleting this group result when it shows “dEL y” then the display will show
“User + donE”, and then the average value of the latest three records will show. (If the records are less than 3 groups, it will display the latest record instead).

INFORMATION FOR USER

Tips for Measurement
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.

Put in a dry place and avoid the sunshine
Avoid touching water, clean it with a dry cloth in case.
Avoid intense shaking and collisions
Avoid dusty and unstable temperature environment
Using wet cloths to remove dirt
Do not attempt to clean the reusable cuff with water and never immerse the cuff in water.

ABOUT BLOOD PRESSURE

What are systolic pressure and diastolic pressure? Blood-
presure 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:

Blood-presure 2

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)

| Optimal| Normal| High-normal| Mild| Moderate| Severe
---|---|---|---|---|---|---
SYS| <120| 120-129| 130-139| 140-159| 160-179| ≥180
DIA| <80| 80-84| 85-89| 90-99| 100-109| ≥110

Irregular Heartbeat Detector

An irregular heartbeat is detected when a heartbeat rhythm varies while the device is measuring systolic pressure and diastolic pressure. During each measurement, blood pressure monitor will keep a record of all the pulse intervals and calculate the average value of them. If there are two or more pulse intervals , the difference between each
interval and the average is more than the average value of ±25% , or there are four or more pulse intervals ,the difference between each interval and the average is more
than the average value of ±15%, then the irregular heartbeat symbol will appear on the display with the measurement result.

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

Why does my blood pressure ﬂuctuate throughout the day?

Individual blood pressure varies multiple times everyday. It is also affected by the way you tie your cuff and your measurement position, so please take the measurement under the same conditions.
If the person takes medicine, the pressure will vary more.
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. Blood-
presure 4

TROUBLE 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 products not operating as you think it should, check here before arranging for servicing.

PROBLEM	SYMPTOM	CHECK THIS	REMEDY

No power

|

Display will not light up.

|

Batteries are exhausted.

|

Replace with new batteries

Batteries are inserted incorrectly.| Insert the batteries correctly
Low batteries| Display is dim or show|

Batteries are low.

|

Replace with new batteries

Error message

| E 01 shows| The cuff is too tight or too loose.| Refasten the cuff and then measure again.
E 02 shows| The monitor detected motion or talking during measuring.| Movement can affect the measurement. Relax for a moment and then measure again.
E 03 shows| The measurement process does not detect the pulse signal.| Loosen the clothing on the arm and then measure again.
E 04 shows| Measurement failed.| Relax for a moment and then measure again.

EExx, shows on the display.

|

A calibration error occurred. (XX can

be some digital symbol, such as 01, 02,etc., if this similar situation appear, all belong to calibration error.)

| 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.

Warning message

|

“OUt ” shows

|

Out of measurement range

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

SPECIFICATIONS

Power supply| Battery powered mode:

6VDC 4×AA batteries __

AC adaptor powered mode: 6V ____ 1A (not included) (Please only use the recommended AC adaptor model).

---|---
Display mode|

Digital LCD display V.A.80mm×58.5mm

Measurement mode|

Oscillographic testing mode

Measurement range

| Rated cuff pressure: 0mmHg~299mmHg (0kPa~39.9kPa) Measurement pressure:

SYS: 60mmHg~230mmHg (8.0kPa~30.7kPa) DIA: 40mmHg~130mmHg (5.3kPa~17.3kPa) Pulse value: (40-199) beats/minute

Accuracy| Pressure:

5°C – 40°C within±3mmHg(0.4kPa) Pulse value:±5%

Normal working condition

| 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

Storage & transportation condition| Temperature:-20°C to +60°C

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

Measurement perimeter of the upper arm|

About 22cm~42cm

Weight| Approx.254g(Excluding the batteries and cuff)
External dimensions| Approx.140.4mm×110.4mm×64.8mm
Attachment| user manual, bag
Mode of operation| Continuous operation
Degree of protection| Type BF applied part
Protection against ingress of water| IP21 It means the device could protected against solid foreign objects of 12.5mm and greater, and protect against vertically falling water drops.

Device Classiﬁcation

| Battery Powered Mode:

Internally Powered ME Equipment

AC Adaptor Powered Mode: Class II ME Equipment

Software Version| A04

AUTHORISED COMPONENTS

Authorised Components
please use the Kinetik authorised adapter. (not included)

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.

COMPLIED STANDARDS LIST AND EMC GUIDANCE

Complied Standards List

Risk management

|

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

---|---

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

User manual| EN 1041:2008+A1:2013 Information supplied by the manufacturer of medical devices
General Requirements for Safety| 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

Electromagnetic compatibility| 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
Performance requirements| 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 80601-2-30:2018 Medical electrical equipment- Part 2-30: Particular requirements for the basic safety and essential performance of automated non- invasive sphygmomanometers

Clinical investigation

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

ISO 81060-2:2018 Non-invasive sphygmomanometers – Part 2: Clinical validation of automated measurement type

Usability

| 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

Software life-cycle processes| EN 62304:2006/AC: 2008 / IEC 62304: 2006+A1:2015 Medical device

software – Software life-cycle processes

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

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 WBP2, including cables specified by the manufacturer. Otherwise, degradation of the performance of this equipment could result.

Technical description:

all necessary instructions for maintaining BASIC SAFETY and ESSENTIAL PERFOR-MANCE with regard to electromagnetic disturbances for the excepted service life.
Guidance and manufacturer’s declaration-electromagnetic emissions and Immunity

Table 1:

Guidance and manufacturer’s declaration – electromagnetic emissions

Emissions test

|

Compliance

RF emissions CISPR 11|

Group 1

RF emissions CISPR 11

|

Class [B]

Harmonic emissions IEC 61000-3-2

|

Class A

Voltage fluctuations/ flicker emissions

IEC 61000-3-3

|

Comply

Table 2:

Guidance and manufacturer’s declaration – electromagnetic Immunity

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

Electrostatic discharge (ESD) IEC 61000-4-2

|

±8 kV contact

±2 kV, ±4kV, ±8 kV, ±15 kV air

|

±8 kV contact

±2 kV, ±4kV, ±8 kV,

±15 kV air

Electrical fast transient/burst IEC 61000-4-4| ±2 kV for power supply lines

±1 kV signal input/output 100 kHz repetition frequency

| ±2 kV for power supply lines

±1 kV signal input/output 100 kHz repetition frequency

Surge IEC61000-4-5| ±0.5 kV, ±1 kV differential mode

±0.5 kV, ±1 kV, ±2 kV common mode

| ±0.5 kV, ±1 kV differential mode

±0.5 kV, ±1 kV, ±2 kV common mode

Voltage dips, short interruptions and voltage variations on power supply input lines

IEC 61000-4-11

| 0 % UT; 0,5 cycle. At 0°, 45°, 90°,

135°, 180°, 225°, 270° and 315°.

0 % UT; 1 cycle and 70 % UT; 25/30 cycles;

Single phase: at 0°.0 % UT; 250/300 cycle

| 0 % UT; 0,5 cycle. At 0°, 45°, 90°,

135°, 180°, 225°, 270° and 315°.

0 % UT; 1 cycle and 70 % UT; 25/30 cycles; Single phase: at 0°. 0 % UT; 250/300 cycle

Power frequency magnetic field IEC 61000-4-8

|

30 A/m

50Hz/60Hz

|

30 A/m

50Hz/60Hz

Conduced RF IEC61000-4-6

| 3 V

0,15 MHz – 80 MHz

6 V in ISM and amateur radio bands between 0,15 MHz and 80 MHz 80 % AM at 1 kHz

| 3 V

0,15 MHz – 80 MHz

6 V in ISM and amateur radio bands between 0,15 MHz and 80 MHz 80 % AM at 1 kHz

Radiated RF IEC61000-4-3| 10 V/m

80 MHz – 2,7 GHz

80 % AM at 1 kHz

| 10 V/m

80 MHz – 2,7 GHz

80 % AM at 1 kHz

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

Table 3:

Guidance and manufacturer’s declaration – electromagnetic Immunity|
---|---
Radiated RF| Test| Band| Service| Modulation| Modulation| Distance (m)| IMMUNITY|
IEC61000-4-3

(Test specifications

| Frequency

(MHz)

| (MHz)| (W)| TEST

LEVEL

(V/m)

|
for| 385| 380-

390

| TETRA 400| Pulse modulation b) 18Hz| 1.8| 0.3| 27|
ENCLOSURE
PORT
IMMUNITY to
450| 430-

470

| GMRS 460,

FRS 460

| FM c) ± 5kHz deviation 1kHz sine| 2| 0.3| 28|
RF wireless
communica-
tions
equipment)| 710| 704-| LTE Band| Pulse| 0.2| 0.3| 9|
745| 787| 13,| modulation b)
17| 217Hz
780
810| 800-| GSM| Pulse| 2| 0.3| 28|
960| 800/900,| modulation b)
870
TETRA 800,| 18Hz
iDEN 820,
930
CDMA 850,
LTE Band 5
1720| 1700-| GSM 1800;| Pulse| 2| 0.3| 28|
1990| CDMA 1900;| modulation b)
1845
GSM 1900;| 217Hz
DECT;
1970| LTE Band 1,
3,
4,25; UMTS
2450| 2400-| Bluetooth,| Pulse| 2| 0.3| 28|
2570| WLAN,| modulation
802.11| 217 Hz
b/g/n, RFID
2450, LTE
Band 7
5240| 5100-| WLAN| Pulse| 0.2| 0.3| 9|
5800| 802.11| modulation
5500
a/n| 217 Hz
5785