ETA3297 Upper Arm Blood Pressure Monitor Instructions

ETA3297 Upper Arm Blood Pressure Monitor

INSTRUCTIONS FOR USE

Dear customer, thank you for purchasing our product. Please read the operating instructions carefully before putting the appliance into operation and keep these instructions including the warranty, the receipt and, if possible, the box with the internal packing.

SAFETY WARNING

• Consider the instructions for use as a part of the appliance and pass them on to any other user of the appliance.

• The appliance is intended for use in households only and for similar use!
  It is not intended for use in health-care facilities and for commercial use! The values measured are intended for your information and monitoring the trends only and must not in any way replace a visit to the physician and having the blood pressure checked under qualified supervision. Proper blood pressure measurement must be performed by a qualified person (physician, nurse etc.) and in the context of an overall health condition of the person.

• This appliance must not be used by children. This appliance can be used by persons with reduced physical, sensory or mental capabilities or lack of experience and knowledge if they have been given supervision or instruction concerning use of the appliance in a safe way and understand the hazards involved. Children shall not play with the appliance. Cleaning and user maintenance shall not be made by children without supervision. Children younger than 8 years must be kept out of reach of the appliance and its power cord.

• To power the appliance, only use the adapter included.

• If the adaptor of the appliance is corrupted, it has to be replaced by the manufacturer, its service technician or a similarly qualified person so as to prevent dangerous situations.

• Never use the appliance if its adaptor or plug is damaged, if it does not work properly, if it fell down and was damaged. In this case take the appliance to a special service to check its safety and proper function.

• Before replacement of accessories or accessible parts, before assembly and disassembly, before cleaning or maintenance, switch off the appliance and unplug adaptor from the mains!

• Always unplug the appliance from charger if you leave it unattended.

• The appliance with the plugged adapter must not be used at places where it could fall into a bath tub, a wash basin or a swimming pool. If the appliance fell to water anyway, do not take it out! First of all, unplug the adapter from the socket and only then remove the appliance. In this case take the appliance to a special service to check its safety and proper function.

• To power the appliance, only apply safe small voltage in accordance with the type plate.

• Do not put or take out the plug of the adapter to or from a socket with wet hands!

• The adaptor supplied with this appliance is intended for this appliance only, do not use it for other purposes. Also, use only the supplied adaptor with this appliance, do not use any other adaptor for charging (e.g. from another appliance).

• Never immerse the device or adapter in water or other liquids (nor partially), do not expose them to moist and do not wash them under the tap!

• The power cord of the adapter must not be damaged with sharp or hot objects, open fire and it must not be sunk into water.

• Please note that the data obtained from the device are only approximate and inaccurate in comparison with the results of real medical analyses. Precise assessment can be made only by a physician using appropriate instruments.

• Do not use rechargeable accumulators.

• If the battery is leaking, remove it immediately; it can damage the device.

• Dispose of a discharged batteries in a suitable way (see par. VII. ENVIRONMENTAL PROTECTION).

• Keep batteries and appliance out of reach of children and incapacitated people. A person, who would swallow the batteries, must seek medical help immediately.

• All text in other languages and pictures shown on the packaging, or the product itself, are translated and explained at the end of this language mutation.

• WARNING: There is a risk of injury in case of incorrect use (not in accordance with the manual) of the appliance.

• The producer is not responsible for damage caused by improper use of the appliance and its guarantee does not cover the appliance in the case of failure to comply with the safety warnings.

• 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.

• 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 samb 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.

• 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.

• The patient is an intended operator.

• The patient can measure data and change batteries 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, 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.

• 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.

• The operator shall not touch output of batteries and the patient simultaneously.

• 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.

• 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.

• 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

• 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.

• This product has been factory calibrated. Generally we recommend to calibrate appliance every 2 years if used regularly

GENERAL INFORMATION

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 theb systolic and diastolic pressure, and also pulse rate.

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:

Blood Presure (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

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.

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.

PREPARATION FOR USE

Remove all the packing material and remove the pressure gauge. Remove adhesive film, stickers, or paper. Choose your power supply – you can use battery power or AC power using an adapter.

Replacing batteries

Open the battery cover on the bottom of the device. Insert a battery with the right polarity and close the cover. Use AAA batteries (4 pcs) for this appliance. If you are not using the appliance for some time, take the batteries out!

Note
– Do not use different type of batteries: Do not use used and new 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.

Descriptions (obr.1)

A – monitor
A1 – START/STOP button
A2 – S (SET) button
A3 –  M (MEM) button
A4 – LCD display
A5 – AIR CONNECTOR PLUG
A6 – BATTERY COMPARTMENT
A7 – hole for adapter connection
A8 – USER button
B – cuff
C – air hose

DISPLAY DESCRIPTION

heartbeat during measurement.
| Blood pressure level indi- cator| Indicate the blood pressure level
| Current Time| Year/Month/Day, Hour/Minute
| Heartbeat| Blood pressure monitor is detecting a heartbeat during measurement.
| User 1/User 2| Start measurement for User 1/User 2
| The average value| The average value of the latest three records

INSTRUCTIONS FOR USE

A) SETTING DATE, TIME AND MEASUREMENT UNIT
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: 2018-2058 time format: 12/24H)

1. When the monitor is off, press “S” button shortly, it will display the time. Then hold pressing “S” button to enter the mode for year setting.
2. Press the “S” to change the [YEAR]. Each press will increase the numeral by one in a cycling manner.
3. When you get the right year, press “S” to set down and turn to next step. Repeat step 2 and 3 to set the [MONTH] and [DAY].
4. Repeat step 2 and 3 to set the time FORMAT [24/12].
5. Repeat step 2 and 3 to set the [HOUR] and [MINUTE].
6. Repeat step 2 and 3 to set the [UNIT].
7. After the unit is setted, the LCD will display “dONE” first, then display all the settings you have done and then it will turn off.

B) SELECT THE USER

1. When the monitor is off, press the ,,M” button shortly to enter user setting mode.
2. Then press ,,USER” button, select the user ID between user A and user B.
3. After selecting the suitable user ID, press ,,START/STOP” button to confirm.
   Then the LCD will turn off.

C) TIE THE CUFF (fig. 2, 3 a 4) 1)

1. Remove all jewelry, 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). Fig.2 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. Fig.3

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. Fig.4

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.

D) START THE MEASUREMENT

1. When the monitor is off, press the “START/STOP” to turn on the monitor.
   

2. Press the “START/STOP” to power off, otherwise it will turn off within 1 minute.

Note
At the beginning of the measurement or during the measurement, you can change the current user by pressing the „USER“ button, under which the result will save.

E) RECALL THE RECORDS

1. When the monitor is off, please press the “M” to show the average value of the latest three records. If the records are less than three groups, it will display the latest record first.
2. Press the “M” or “S” to get the record you want.
   

CAUTION
The most recent record (1) is shown first. Each new measurement is assigned to the first (1) record. All other records are pushed back one digit (e.g., 2 becomes 3, and so on), and the last record (250) is dropped.
– To view the data of the other user, simply press the „USER“ button.

F) DELETE THE RECORDS
If you did not get the correct measurement, you can delete all results by following steps below.

1. Hold pressing “M” for 3 seconds when the monitor is in the memory recall mode, the flash display will show , ,dEL ALL”.
2. Press “S” to confirm deleting, the monitor will display “dEL donE” and then turn off.
3. If you don’t want to delete the records, press “START/STOP” to escape.
4. If there is no record, the display will show ,, – – – “.

TIP
Although this appliance does not support direct pairing with smart applications, you can still use our partner MedM BP application (available for both Android and iOS) for a thorough record, browsing charts and measurement history, and last but not least, measurement history export. After registration, you can enter each measurement manually by clicking on the “+” on the app homepage.

TROUBLESHOOTING OF POSSIBLE PROBLEMS

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

---|---|---|---
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 while measuring.| Movement can affect the measurement.Relax for a moment and then measure again.
E 03 shows| The measurement process does not de- tect the pulse signal.| Loosen the clothing on the wrist and then measure again.
E 04 shows| The treatment of the measurement failed.| Relax for a moment and then measure again.
EExx, shows on the display.| A calibration error occurred.| 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.
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.

MAINTENANCE

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.

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

– Put in a dry (including adaptor) 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.

More extensive maintenance or maintenance requiring intervention in the inner parts of the appliance must be carried out by a professional service! Failure to comply with the instructions of the manufacturer will lead to expiration of the right to guarantee repair!

ENVIRONMENTAL PROTECTION

If the dimensions allow, there are labels of materials used for production of packing, components and accessories as well as their recycling on all parts.
The symbols specified on the product or in the accompanying documentation mean that the used electrical or electronic products must not be disposed of together with municipal waste. For proper disposal, hand them over at special collection places where they will be accepted free of charge. Suitable disposal of the product can help to maintain valuable natural resources and to prevent possible negative impacts on the environment and human health, which could be the possible consequences of improper waste disposal.
Ask for more details at the local authorities or at a collection site. Fines can be imposed for improper disposal of this type of waste in agreement with the national regulations. Remove a discharged battery and dispose of it in a suitable and safe way through the special collection networks. Never dispose of the battery by burning!

TECHNICAL DATA

0 mm Hg ~ 299 mmHg (0 kPa ~ 39.9 kPa)
Measurement pressure:
SYS: 60 mm Hg ~ 230 mmHg (8.0 kPa ~ 30.7 kPa)
DIA: 40 mmHg ~ 130 mmHg (5.3 kPa ~ 17.3 kPa)
Pulse value: ( 40-199) beat/minute
Accuracy| Pressure : 5 °C – 40 °C within ±0.4 kPa (3 mmHg)
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 temperature| -20 °C ~ +60 °C, less than 93 % HR non-condensing, at a water vapour pressure up to 50 hPa
Measurement perimeter of the upper arm| About 22 cm – 42 cm
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
Power supply| 4 x 1,5 V AAA (included)
Adaptor (model BLJ06W060100P1-U); AC 100-240V;
50/60Hz 0.2 A Max; Napětí 6 V        1000 mA
Net weight of device| 0,25 kg
Size of the product (mm)| 140 x 130 x 50
Degree of protection| Type BF applied part
Software version**| A01

WARNINGS AND SYMBOLS USED ON THE APPLIANCE, PACKAGING OR IN THE INSTRUCTIONS MANUAL:

HOUSEHOLD USE ONLY. DO NOT IMMERSE IN WATER OR OTHER LIQUIDS.
TO AVOID DANGER OF SUFFOCATION, KEEP THIS PLASTIC BAG AWAY FROM BABIES AND CHILDREN. DO NOT USE THIS BAG IN CRIBS, BEDS, CARRIAGES OR PLAYPENS. THIS BAG IS NOT A TOY.

Manufactured by: Guangdong Transtek Medical Electronics Co., Ltd.
Zone A, No.105 ,Dongli Road, Torch Development District
Zhongshan,528437,Guangdong,China
Authorized European Representative:
MDSS – Medical Device Safety Service GmbH; Schiffgraben 41, 30175 Hannover, Germany
Importer: ETA a.s.; Křižíkova 148/34; Praha 8 – Karlín, 186 00

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 disturbances – 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 80601-2-30:2009+A1:2013 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 81060-2:2013 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 TMB-1490-CS, including cables specified by the manufacturer. Otherwise, degradation of the performance of this equipment could result.

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| 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 transi- ent/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
IEC61000-4-3 (Test speci- fications for ENCLOSURE PORT IMMUNITY to RF wireless communications equipment)| Test Frequency (MHz)| Band (MHz)| Service| Modulation| Modulation (W)| Distance (m)| IMMUNITY TEST LEVEL (V/m)
385| 380-390| TETRA 400| Pulse modulation b)

18Hz

| 1,8| 0,3| 27
450| 430-470| GMRS 460, FRS 460| FM c) ± 5kHz deviation 1kHz

sine

| 2| 0,3| 28
710| 704-787| LTE Band 13,17| Pulse modulation b)

217Hz

| 0,2| 0,3| 9
745
780
810| 800-960| GSM 800/900, TETRA 800, iDEN 820, CDMA 850, LTE Band 5|

Pulse modulation b) 18Hz

| 2| 0,3| 28
870
930
1720| 1700- 1990| GSM 1800; CDMA 1900;

GSM 1900; DECT;

LTE Band 1,

3,

4,25; UMTS

| Pulse modulation b) 217Hz| 2| 0,3| 28
1845
1970
2450| 2400-

2570

| Bluetooth, WLAN, 802.11

b/g/n, RFID 2450, LTE

Band 7

| Pulse modulation 217 Hz| 2| 0,3| 28
5240| 5100- 5800| WLAN 802.11 a/n| Pulse modulation 217 Hz| 0,2| 0,3| 9
5500
5785

References

• AEG Hausgeräte | Setzen Sie auf Qualität | AEG
• ETA - tady je doma
• ETA - tu je doma

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