INTRODUCTION

General Description
Thank you for selecting arm type SAMSUNG ARM BPM ( EI-B5000 ). The monitor features blood pressure measurement, pulse rate measurement, and result storage. The design provides you with two years of reliable service.
Readings taken by the EI-B5000 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 step-by-step instructions for using the product, please read it thoroughly before using it.
Features:

  • Up to 60 pieces of a record stored for each user
  • 3rd technology: Measuring during inflation

Indications for Use
The SAMSUNG ARM BPM is a digital monitor intended for use in measuring blood pressure and heartbeat rate with an arm circumference ranging from 22cm to 42cm(about 8¾˝-16½˝). It is intended for adult indoor use only.
Contraindications

  1. The device should not be used by any person who may be suspected of, or is pregnant.
  2. The device is not suitable for use on patients with implanted, electrical devices, such as cardiac pacemakers, and defibrillators.

Measurement Principle
This product uses the Oscillometric Measuring Method to detect blood pressure. Before every measurement, the unit establishes a “zero point” equivalent to the atmospheric pressure. Then it starts inflating the cuff. Meanwhile, the unit detects pressure oscillation generated by beat-to-beat pulsatile, which is used to determine the systolic pressure and diastolic pressure as well as pulse rate.
Safety Information
The signs below might be in the user manual, labeling, or other components. They are the requirement of the standard and use.

The symbol for “THE OPERATION GUIDE MUST BE READ”The symbol for “TYPE BF APPLIED PARTS”
ICONThe symbol for “MANUFACTURER”The 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”
SNThe symbol for “SERIAL NUMBER”
 Direct CurrentThe symbol for “DIRECT CURRENT”
The symbol for “RECYCLE”ICONThe symbol for “MANUFACTURE DATE”
Caution: These notes must be observed to prevent any damage to the device.SymbolThe symbol for “Authorised Representative in the European Community

 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, electronic 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 armor 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 prescribed medication without consulting your physician.
  • Do not take any therapeutic measures on the basis of a self-measurement. Never alter the dose of medicine prescribed by a doctor. Consult your doctor if you have any questions about your blood pressure.
  • When the device is 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.

 CAUTION

  • When using this device, please pay attention to the following situation which may interrupt blood flow and influence blood circulation of the patient, thus causing 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.

warning CAUTION

  • 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 81060-2:2018.
  • 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 anesthetic, 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 the incorrect application.
  • This device comprises sensitive components and must be treated with caution. Observe the storage and operating conditions described in this booklet.
  •  The maximum temperature that the applied part can be achieved is 42.8℃ while the environmental temperature is 40℃.
  • The equipment is not AP/APG equipment and not suitable for use in the presence of a flammable anesthetic mixture with air of 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, and charge power under normal circumstances and maintain the

 CAUTION
device and its accessories according to the user manual.

  • To avoid measurement errors, please avoid the condition of the 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 the requirements of ISO 10993-5:2009 and ISO 10993-10:2010. It will not cause any potential sensation or irritation reaction.
  • The adaptor is specified as a part of ME EQUIPMENT.
  • If you experience discomfort during measurements, such as pain in the arm or other complaints, press any 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 the pressure reaches 40 kPa (300 mmHg), detach the cuff from the arm and press any 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!

 CAUTION

  • 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.
  •  The manufacturer will make available on request circuit diagrams, component part lists, descriptions, calibration instructions, etc., to assist service personnel in parts repair.
  • The plug/adapter plug pins insulate 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 the operation of ME equipment.
  • The operator shall not touch the output of the batteries /adapter and the patient simultaneously.
  • Cleaning: A dust environment may affect the performance of the unit. Please use a 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 it, please contact the SERVICE PERSONNEL of SAMSUNG. 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 SAMSUNG if any unexpected operations or events occur.

 CAUTION

  • 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 the intended use. At least 30 min required for ME equipment to cool from the maximum storage temperature between uses until it is ready for the 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, and walkie-talkies can affect this
    equipment and should be kept at least a distance away from the equipment. The distance d is calculated by the MANUFACTURER from the 80MHz to 5.8 GHz column of Table 4 and Table 9 of IEC 60601-1-2:2014, as appropriate.
  • Please use ACCESSORIES and detachable parts specified/authorized by MANUFACTURE. Otherwise, it may cause damage to the unit or danger to the user/patients.
  • There is no Luer lock connectors 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 is provided in the user manual. Otherwise, the performance and lifetime of the device will be impacted and reduced.

LED Display Signal

SAMSUNG EI B5000 Arm BPM Device - Signal
SYMBOLDESCRIPTIONEXPLANATION
SYSSystolic blood pressureHigh-pressure result
D IADiastolic blood pressureLow-pressure result
HRPulsePulse/minute

Components of the Device

SAMSUNG EI B5000 Arm BPM Device - Device

Component list of pressure measuring system:

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

List

  1. SAMSUNG ARM BPM (EI-B5000)
  2. Cuff (22~42cm) (Type BF applied part)
  3. User manual
  4. 4*AAA batteries

The Choice of Power Supply

  1. Battery-powered model: 6VDC 4*AAA batteries

 CAUTION
In order to get the best effect and protect your monitor, please use the right batteries and a special power adapter that complies with the local safety standards.

Installing and Replacing the Batteries
If this is your first time using the device:

  1. Slide open the battery door on the back of the device.
  2. Install the batteries provided with the device. Follow the diagram inside the battery compartment for correct polarity—the springs should align with the negative sign on the batteries.
  3. Slide the battery door closed.

BEFORE YOU START

Replace the batteries whenever the below happens

  • The SAMSUNG EI B5000 Arm BPM Device - icon2symbol shows.
  • The display dims
  • The display does not light up

 CAUTION

  • Do not use new and used batteries together.
  • Do not use different types of batteries together.
  • Do not dispose of the batteries in a 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 of daily garbage.
  • Remove the old batteries from the device following your local recycling guidelines.

Install the App and Pair-Up

  • Download the SAMSUNG HEALTH app from APP Store or Google Play.
  • Install the APP, and register an account. Click “Manage items” add “Blood pressure”, and then click “Save”.
SAMSUNG EI B5000 Arm BPM Device - app2
SAMSUNG EI B5000 Arm BPM Device - app1
SAMSUNG EI B5000 Arm BPM Device - app3

Click, choose “Accessories”, click “Scan for accessories” and add “Samsung Arm Bpm”
Search your test information
After the measurement is finished, the message will be sent to app automatically, click SAMSUNG EI B5000 Arm BPM Device - icon4to check your test history.
RF Frequency Range: 2402MHz to 2480MHz
Output Power Range: ≤ 0 dBm
Supply Voltage: 4.0-7.2V
Transmitting Distance: 10 meters
List of compatible devices:
For iOS devices:
The operating system must be iOS 8 or more, such as iPhone
4S, iPhone 5/5C/5S, iPhone 6/6 Plus and so on.
For Android devices:
The operating system must be 4.3 or more.

 CAUTION

  • Interference may occur in the vicinity of equipment marked with the following symbol . And EI-B5000 may interfere with vicinity electrical equipment.
  • Sensitive people, including pregnant women pre-eclamptic and those who implanted medical electronic instruments, should avoid using the unit whenever possible.
  • Keep the monitor at least 20 centimeters away from the human body (especially the head) when the data transmission is proceeding after measurement.
  • To enable the data transmission function, this product should be paired to a Bluetooth end at 2.4 GHz.

How to mitigate possible interference?
The range between the device and the BT end should be reasonably close, from

  1.  a meter to 10 meters. Please ensure no obstacles between the device and BT end so as to obtain a quality connection and to lower the RF output range.
  2.  To avoid interference, other electronic devices (particularly those with wireless transmission / Transmitter) should be kept at least 1 meter away from the monitor.

Setting the User

  1. When the monitor is off, press the “ START/STOP ” button to turn on the monitor, and it will show the current user. Long press the “START/STOP” button again to switch the user. There are 3 users in total and guest mode. (User mode stores 60 groups messages, the guest mode doesn’t store messages.

MEASUREMENT

SAMSUNG EI B5000 Arm BPM Device - Cuff

Tie the Cuff

  1. Remove all accessories (watch, bracelet, etc) from your arm. If your physician has diagnosed you with poor circulation in your arm, use the other one.
  2. Roll or push up your sleeve to expose the skin.
  3. Apply the cuff to your arm with your palm facing up.
  4. Position the edge of the cuff about 2cm~3cm from the elbow.
  5. Fasten the cuff around your arm, leaving no extra room between the cuff and your skin. If the cuff is too loose, the measurement will not be accurate.
  6. 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.
  7. Helpful tips for Patients, especially for Patients with Hypertension:
  • Rest for 5 minutes before the first measurement.
  • Wait at least 3 minutes between measurements. This allows your blood circulation to
  • Take the measurement in a silent room.
  • The patient must relax as much as possible and 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.
SAMSUNG EI B5000 Arm BPM Device - fig1

Taking a Measurement

  1. After setting the User, press the “START/STOP” button again, and then the monitor will complete the measurement automatically.
    SAMSUNG EI B5000 Arm BPM Device - fig2After the measurement was finished, the Systolic pressure, Diastolic pressure and heart rate will show up alternately
    SAMSUNG EI B5000 Arm BPM Device - fig3
  2. This device will proceed to data transmission automatically after measurement.
    SAMSUNG EI B5000 Arm BPM Device - fig4
  3. If the data is successfully transmitted, the LCD will display SAMSUNG EI B5000 Arm BPM Device - icon3and then the device will turn off.
SAMSUNG EI B5000 Arm BPM Device - fig5

If the data transmission fails, the monitor will turn off automatically.
Tip:
You can press the “ START/STOP ” button at any time to stop measuring during the process of measurement.

INFORMATION FOR USER

SAMSUNG EI B5000 Arm BPM Device - fig6
SAMSUNG EI B5000 Arm BPM Device - fig7

Tips for Measurement
Measurements may be inaccurate if taken in the following circumstances.
Maintenance
In order to get the best performance, please follow the instructions below.

ABOUT BLOOD PRESSURE

SAMSUNG EI B5000 Arm BPM Device - fig8
SAMSUNG EI B5000 Arm BPM Device - fig9

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 the World Health Organization (WHO) and International Society of Hypertension (ISH) in 1999 is as follows:

 CAUTION
Only a physician can tell you’re 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)OptimalNormalHigh-normalMildModerateSevere
SYS<120120-129130-139140-159160-179≥180
DIA<8080-8485-8990-99100-109≥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, SAMSUNG ARM BPM 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 heartbeat 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?

  1. Individual blood pressure varies multiple times every day. It is also affected by the way you tie your cuff and your measurement position, so please take the measurement under the same conditions.
  2. If the person takes medicine, the pressure will vary more.
  3. Wait at least 3 minutes for another measurement.
SAMSUNG EI B5000 Arm BPM Device - fig10
SAMSUNG EI B5000 Arm BPM Device - fig11

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.

TROUBLESHOOTING

This section includes a list of error messages and frequently asked questions for problems you may encounter with your SAMSUNG ARM BPM. If the products not operating as you think you should check here before arranging for servicing.

PROBLEM……………………. SYMPTOMCHECK THISREMEDY
No power
or Low batteries
Disp Display will not light up orSAMSUNG EI B5000 Arm BPM Device - icon2 showsBatteries are exhausted.Replace with new batteries
Batteries are inserted incorrectly.Insert the batteries correctly
Error messageE 01 showsThe cuff is not secure or Inflatable abnormal.Refasten the cuff and then measure again.
E 02 showsThe monitor detected motion, talking or the pluse is too poor while measuring.Movement can affect the measurement. Relax for a moment and then
measure again.
E 03 showsThe measurement process does not detect the pulse signal.Loosen the clothing on the arm and then measure again
E 04 showsThe treatment of the measurement failed.Relax for a moment and then measure again.
EEx 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 instructions.
Warning message“our showsOut of measurement rangeRelax for a moment. Refasten the cuff and then measure again. If the problem persists, contact your physician.

SPECIFICATIONS

Power supplyBattery-powered model: 6VDC 4×AAA batteries
Measurement modeOscillographic testing mode
Measurement rangeRated cuff pressure: mmHg-299mmHg (OkPa – 39.9kPa)
Measurement pressure: SYS: 60mmHg-230mmHg (8.0kPa-30.7kPa) DIA: 40mmHg-130mmHg (5.3kPa-17.3kPa) Pulse value: (40-199)beatiminute
AccuracyPressure: 5°C-40°C within ± 3mmHg (0.4kPa) Pulse value: ±5%
Normal working conditionA temperature range of: +5°C to +40°C A relative humidity range of 15% to 90%, non-condensing, but not requiring a water vapor partial pressure greater than 50 hPa An  atmospheric pressure range of: 700 hPa to 1060 hPa
Storage & transportation conditiontuhumidityre: -20 °C to +60°C 0
Temperature: A   range of 5 93 A., non-condensing, at a water vapor pressure up to 50hPa
Measurement perimeter of the upper armAbout 22cm-42cm
WeightApprox.285g(Excluding the batteries)
External dimensionsApprox.159mm*50mm*27mm
Attachment4 AAAA batteries.user manual
Mode of operationContinuous operation
Degree of protectionType BF applied part
Protection against ingress of waterIP22: The first number 2: Protected against solid foreign objects of 12,5mm 0 and greater. The second number: Protected against vertically falling water drops when enclosure titled up to 15°.
Vertically falling drops shall have no harmful effects when the enclosure is tilted at any angle up to 15° on either side of the vertical
Device ClassificationBattery Powered Mode: Internally Powered ME Equipment
Software VersionA01

Contact Information

For more information about our products, please visit www.transtekcorp.com. you can get customer service, usual problems, and customer download, Transtek will serve you anytime.
Manufactured by: Guangdong Transtek Medical Electronics Co., Ltd.
Company: Guangdong Transtek Medical Electronics Co., Ltd.
Address: Zone A, No.105, Dongli Road, Torch Development District, Zhongshan,528437, Guangdong, China

FCC Statement

contains FCC ID:OU9TMB207401
This device complies with Part 15 of the FCC Rules. Operation is subject to two conditions: (1) this device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation.
Caution: The user is cautioned that changes or modifications not expressly approved by the party responsible for compliance could void the user’s authority to operate the equipment.
NOTE: This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to Part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference in a residential installation. This equipment generates, uses, and can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to radio communications. However, there is no guarantee that interference will not occur in a particular installation. If this equipment does cause harmful interference to radio or television reception, which can be determined by turning the equipment off and on, the user is encouraged to try to correct the interference by one or more of the following measures:

  • Reorient or relocate the receiving antenna.
  • Increase the separation between the equipment and receiver.
  • Connect the equipment into an outlet on a circuit different from that to which the receiver is connected.
  • Consult the dealer or an experienced radio/TV technician for help.

FCC Radiation Exposure Statement:
This equipment complies with FCC radiation exposure limits set forth for an uncontrolled environment. This transmitter must not be co-located or operating in conjunction with any other antenna or transmitter.

Complied Standards List

Risk managementEN ISO 14971:2012 / ISO 14971:2007 Medical devices – Application of risk management to medical devices
LabelingEN ISO 15223-1:2016 / ISO 15223-1:2016 Medical devices. Symbols to be used with medical device labels, labeling, and information to be supplied. Part 1: General requirements
User manualEN 1041:2008 +A1:2013 Information supplied by the manufacturer of medical devices
General Requirements for SafetyEN 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 compatibilityEN 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 requirementsEN ISO 81060-1:2012 Non-invasive sphygmomanometers – Part 1: Requirements and test methods for non-automated measurement type 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 investigationEN 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 intermittent automated measurement type
UsabilityEN 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 processesEN 62304:2006/AC: 2008 / IEC 62304: 2006+A1:2015 Medical device software – Software life-cycle processes
Bio-compatibilityISO 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 decrease 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 EI-B5000, 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 testCompliance
RF emissions CISPR 11Group 1
RF emissions CISPR 11Class B
Harmonic emissions IEC 61000-3-2Not applicable
Voltage fluctuations/ flicker emissions
IEC 61000-3-3
Not applicable

Table 2 

Guidance and manufacturer’s declaration — electromagnetic Immunity
Immunity TestIEC 60601-1-2 Test levelCompliance 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 61000-4-4Not applicableNot applicable
Surge IEC61000-4-5Not applicableNot applicable
Voltage dips, short interruptions and voltage variations on power supply input lines IEC 61000-4-11Not applicableNot applicable
Power frequency magnetic field
IEC 61000-4-8
30 Aim 50Hz/60Hz30 A/m 50Hz/60Hz
Conducted RF IEC61000-4-6Not applicableNot applicable
Radiated RF IEC61000-4-310 V/m
80 MHz — 2,7 GHz 80 °/c. 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

SAMSUNG EI B5000 Arm BPM Device - icon1
Guangdong Transtek Medical Electronics Co., Ltd.
Espenstrasse Zone A, No.105, Dongli Road, Torch Development District,
Zhongshan,528437, Guangdong, China
microlife MT 1961 Digital Thermometer - ECMDSS – Medical Device Safety Service GmbH
Schiffgraben 41, 30175 Hannover, Germany

Documents / Resources

SAMSUNG EI-B5000 Arm BPM Device [pdf] User Manual
TMB207401, OU9TMB207401, EI-B5000 Arm BPM Device, Arm BPM Device

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