INTRODUCTION

General Description

Thank you for selecting the HoMedics arm blood pressure monitor. 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 blood pressure monitor 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:

  • 60mm x 40.5 mm LCD
  • Maximum 60 records
  • Measuring during inflation

Indications for Use
The HoMedics Blood Pressure Monitor 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 is not suitable for use on pregnant women or women who think they may be 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 pressure” equivalent to the air pressure.  Then it starts inflating the arm cuff, meanwhile, the unit detects pressure oscillations generated by beat-to-beat pulsatile, which is used to determine the systolic and diastolic pressure, and also pulse rate.

Safety Information
The below signs might be in the user manual, labeling or other components. They are the requirement of standard and use.

Danger iconThe symbol for “THE OPERATION GUIDE
MUST BE READ”
The symbol for “TYPE BF APPLIED PARTS”
123The symbol for “COMPLIES WITH MDD 93/42/EEC REQUIREMENTS”The symbol for “ENVIRONMENT PROTECTION
– Waste electrical products should not be disposed of with household waste.
Please follow local guidelines.
ICONThe symbol for “MANUFACTURER”
SMART METER SMPO1000 US iPulseOx Pulse Oximeter - icon 1The symbol for “SERIAL NUMBER”SymbolAuthorized Representative in the European Community
 Direct CurrentThe symbol for “DIRECT CURRENT”The symbol for “Recycle”
ICONThe symbol for “MANUFACTURE DATE”The Green Dot is the license symbol of a European network of industry-funded systems for recycling the packaging materials of consumer goods.
SP Tools Digital Multimeter Electrical SP62012 - WARNINGCaution: These notes must be observed to prevent any damage to the device

 CAUTION

  • This device is intended for adult use in homes only.
  • The device is not suitable for use on neonatal patients, pregnant women, patients with implanted, electronical devices, patients with pre-eclampsia, premature ventricular beats, atrial fibrillation, peripheral, arterial disease, and patients undergoing intravascular therapy or arterio­venous 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 professional 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 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 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 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 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 equipment is not AP/APG equipment and is 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 data and change batteriesunder normal circumstances and maintain the device and its accessories according to the user manual.
  • To avoid measurement errors, please avoid the condition of a 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 sensitization or irritation reaction.
  • If you experience discomfort during measurement, such as pain in the arm or other complaints, press the START/STOP button to release the air immediately from the 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 reach 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.
  • The manufacturer will make available on request circuit diagrams, component part lists, descriptions, calibration instructions,etc., to assist to service personnel in parts.
  • The operator shall not touch the output of batteries 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
  • 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 HoMedics. 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 HoMedics if any unexpected operations 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 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 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 parts specified/authorized by the MANUFACTURER. 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 no 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 signalHoMEDiCS BPA 3020 EU Automatic Arm Blood Pressure Monitor - display

SYMBOLDESCRIPTIONEXPLANATION
SYSSystolic blood pressureHigh blood pressure
D I ADiastolic blood pressureLow blood pressure
Pul/minPulse displayPulse in beats per minute
DownDeflation symbolThe cuff is deflating.
HoMEDiCS BPA 3020 EU Automatic Arm Blood Pressure Monitor - iconMemoryIndicate it is in the memory mode and which group of memory it is.
kPakPaMeasurement Unit of the blood pressure
rnrnHgmmHgMeasurement Unit of the blood pressure
HoMEDiCS BPA 3020 EU Automatic Arm Blood Pressure Monitor - icon 1Low batteryBatteries are low and need to be replaced
HoMEDiCS BPA 3020 EU Automatic Arm Blood Pressure Monitor - icon 2Irregular heartbeatA blood pressure monitor is detecting an irregular heartbeat during measurement.
HoMEDiCS BPA 3020 EU Automatic Arm Blood Pressure Monitor - icon 4Blood pressure level indicatorIndicate the blood pressure level
HoMEDiCS BPA 3020 EU Automatic Arm Blood Pressure Monitor - icon 5Current TimeYear/Month/Day, Hour/Minute
HoMEDiCS BPA 3020 EU Automatic Arm Blood Pressure Monitor - icon 3HeartbeatA blood pressure monitor is detecting a heartbeat during measurement.
HoMEDiCS BPA 3020 EU Automatic Arm Blood Pressure Monitor - icon 6User 1/User GIUser 2Start measurement for User 1/User GIUser 2
HoMEDiCS BPA 3020 EU Automatic Arm Blood Pressure Monitor - icon 7Motion indicatorMotion may result in an inaccurate measurement i
HoMEDiCS BPA 3020 EU Automatic Arm Blood Pressure Monitor - fig

Replace the batteries under the following circumstances:

  • displays on the LCD
  • The LCD display is dim
  • When powering on the monitor, the LCD doesn’t light up.

Installing and replacing the batteries

  • Open the battery cover.
  •  Install the batteries as indicated in the battery compartment. (Always select the authorized/specified battery: 4 x AAA-size batteries).
  • Replace the battery cover.

CAUTION

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

SETTING DATE, TIME, AND MEASUREMENT UNIT

It is important to set the clock before using your blood pressure monitor so that timestamp can be assigned to each record that is stored in the memory. (The setting range of  the year:2018—2058 time format: 12H/24H)

  1. When the monitor is off, hold pressing “SET” for 3 seconds to enter the mode for the year setting. Or when the monitor is off, press the “SET” button shortly, it will display the time. Then hold pressing the “SET” button to enter the mode for the year setting.
    HoMEDiCS BPA 3020 EU Automatic Arm Blood Pressure Monitor - fig 1
  2. Press the “MEM” to change the [YEAR]. Each press will increase the numeral by one in a cycling manner.
    HoMEDiCS BPA 3020 EU Automatic Arm Blood Pressure Monitor - fig 2
  3. When you get the right year, press “SET” to set down and turn to the next step.
  4. Repeat steps 2 and 3 to set the [MONTH] and [DAY].
  5. HoMEDiCS BPA 3020 EU Automatic Arm Blood Pressure Monitor - fig 3Repeat steps 2 and 3 to set the [HOUR] and [MINUTE].
  6. HoMEDiCS BPA 3020 EU Automatic Arm Blood Pressure Monitor - fig 4Repeat steps 2 and 3 to set the [UNIT].
  7. HoMEDiCS BPA 3020 EU Automatic Arm Blood Pressure Monitor - fig 5After the unit is set, the LCD will display “donE” first, then display all the settings you have done, and then it will turn off.
HoMEDiCS BPA 3020 EU Automatic Arm Blood Pressure Monitor - fig 6

BEFORE YOU START

Select the User

  1. When the monitor is off, press and hold the MEM button to enter user setting mode. The user ID will blink.
    HoMEDiCS BPA 3020 EU Automatic Arm Blood Pressure Monitor - fig 7
  2. Then press the MEM button again, select the user ID user 1 , user 2, or user G.HoMEDiCS BPA 3020 EU Automatic Arm Blood Pressure Monitor - fig 8
  3. After selecting the suitable user ID, press the SET button to confirm. Then the LCD will turn off.
HoMEDiCS BPA 3020 EU Automatic Arm Blood Pressure Monitor - fig 9

MEASUREMENT

Tie the Cuff

  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.
    HoMEDiCS BPA 3020 EU Automatic Arm Blood Pressure Monitor - fig 10
  2. Roll or push up your sleeve to expose the skin. Make sure your sleeve is not too tight.
  3. Hold your arm with your palm facing up and tie the cuff on your upper arm, then position the tube off-center toward the inner side of arm in line with the little finger. Or position the artery mark over the main artery (on the inside of your arm). Note: Locate the main artery by pressing with 2 fingers approximately 2 cm above the bend of your elbow on the inside of your left arm. Identify where the pulse can be felt the strongest. This is your main artery.
  4. The cuff should be snug but not too tight. You should be able to insert one finger between the cuff and your arm.
    HoMEDiCS BPA 3020 EU Automatic Arm Blood Pressure Monitor - fig 11
  5. Sit comfortably with your tested arm resting on a flat surface. Place your elbow on a table so that the cuff is at the same level as your heart. Turn your palm upwards. Sit upright in a chair, and take 5-6 deep breaths.
  6. Helpful tips for Patients, especially for patients with Hypertension:
  • Rest for 5 minutes before first measuring.
  • Wait at least 3 minutes between measurements This allows your blood circulation to recover.
  • Take the measurement in a silent room.
  • The patient must relax as much as possible and do not move and talk during the measurement procedure.
  • The cuff should maintain at the same level as the right atrium of the heart.
  • Please sit comfortably. Do not cross your legs and keep your feet flat on the ground.
  • Keep your back against the backrest of the chair.
  • For a meaningful comparison, try to measure under similar conditions.
    HoMEDiCS BPA 3020 EU Automatic Arm Blood Pressure Monitor - fig 12For example, take daily measurements at approximately the same time, on the same arm, or asdirected by a physician.
HoMEDiCS BPA 3020 EU Automatic Arm Blood Pressure Monitor - fig 13

Start the Measurement
1. When the monitor is off, press the “START/STOP” to turn on the monitor, and it will finish the whole measurement. (Take User 1 for example)

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

DATA MANAGEMENT

Recall the Records

  1. When the monitor is off, please press the “MEM” 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.HoMEDiCS BPA 3020 EU Automatic Arm Blood Pressure Monitor - fig 14
  2. Press the “MEM” or “SET” to get the record you want.
HoMEDiCS BPA 3020 EU Automatic Arm Blood Pressure Monitor - fig 15

 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 (eg 2 becomes 3, and so on), and the last record (60) is dropped.

Delete the records
If you did not get the correct measurement, you can delete all results by following the steps.

  1. Hold pressing “MEM” for 3 seconds when the monitor is in the memory recall mode, the flash display will show.HoMEDiCS BPA 3020 EU Automatic Arm Blood Pressure Monitor - fig 16
  2. Press “SET” to confirm deleting and the monitor will turn off.HoMEDiCS BPA 3020 EU Automatic Arm Blood Pressure Monitor - fig 17
  3.  If you don’t want to delete the records, press “START/STOP” to escape.HoMEDiCS BPA 3020 EU Automatic Arm Blood Pressure Monitor - fig 18
  4.  If there is no record, the above display will show.

INFORMATION FOR USER

Tips for Measurement
Measurements may be inaccurate if taken in the following circumstances.

HoMEDiCS BPA 3020 EU Automatic Arm Blood Pressure Monitor - fig 19
HoMEDiCS BPA 3020 EU Automatic Arm Blood Pressure Monitor - fig 20

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

ABOUT BLOOD PRESSURE

HoMEDiCS BPA 3020 EU Automatic Arm Blood Pressure Monitor - PRESSURE

What are systolic pressure and diastolic pressure?
When ventricles contract and pump blood out of the heart, the blood pressure reaches its maximum value in the cycle, which is called systolic pressure. When the ventricles relax, the blood pressure reaches its minimum value in the cycle, which is called diastolic pressure.

HoMEDiCS BPA 3020 EU Automatic Arm Blood Pressure Monitor -hypertension

What is the standard blood pressure classification?
The blood pressure classification published by World Health Organization (WHO) and International Society of Hypertension (ISH) in 1999 is as follows:

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

Blood Level
pressure (mmHg)
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 unit is measuring the systolic and diastolic blood pressure. During each measurement, the monitor records all the pulse intervals and calculates the average; if there are two or more pulse intervals,the difference between each interval and the average is more than the average value of ±25%, or there are four or more pulse intervals, the difference between each interval and the average is more than the average value of ±15%,the irregular heartbeat symbol appears on the display when the measurement results have appeared.

 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.

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.

HoMEDiCS BPA 3020 EU Automatic Arm Blood Pressure Monitor - measure

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.
HoMEDiCS BPA 3020 EU Automatic Arm Blood Pressure Monitor - calm down

TROUBLESHOOTING

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

PROBLEMSYMPTOMCHECK THISREMEDY
No powerThe display will not light up.Batteries are exhausted.Replace with new batteries
Batteries are inserted incorrectly.Insert the batteries correctly
Low batteriesThe display is dim or showBatteries are low.Replace with new batteries
Error messageE 01 showsThe cuff is too tight or too loose.Readjust the cuff, not too loose or too tight, and then measure again.
E 02 showsThe monitor detected motion,
talking or the pluse is too poor while measuring.
measure again.
Relax for a moment and then
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.
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 instructions.
Warning message“out ” showsOut of measurement rangeRelax for a moment message measure again. If the problem persists, contact your physician.

SPECIFICATIONS

Power supply6VDC 4*AAA batteries
Display modeLCD V.A.60mmx40.5mm
Measurement modeOscillographic testing mode
Measurement rangeRated cuff pressure:
OmmHg-299mmHg (OkPa – 39.9kPa) Measurement pressure:
SYS: 60mmHg-230mmHg (8.0kPa-30.7kPa) DIA: 40mmHg-130mmng (5.3kPa-17.3kPa) Pulse value: (40-199)beatiminute
AccuracyPressure: 5°C-40°C within±0.4kpa(3mmHg) 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 vapour partial pressure greater than 50 hPa An atmospheric pressure range of : 700 hPa to 1060 hPa
Storage & transportation conditionTemperature:-20°C to +60°C
A relative humidity range of 5 93%, non-condensing, at a water vapor pressure up to 50 hPa
Measurement perimeter of the upper armAbout 22cm-42cm
Net WeightApprox.169g (Excluding the dry cells)
External dimensionsApprox.110mmx 110mmx 41mm
Attachment4xAAA batteries,user manual
Mode of operationContinuous operation
Degree of protectionType BF applied part
Protection against ingress of waterIP21 It means the device could protect against solid foreign objects of 12.5mm and greater, and protect against vertically falling water drops.
Device ClassificationBattery Powered Mode: Internally Powered ME Equipment
Software versionA01

CONTACT INFORMATION

For more information about our products, please visit www.homedics.co.uk
Model: TMB-1491-S
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 GmbHSchiffgraben 41,
30175 Hannover,
Germany
Imported into the UK by:
FKA Brands Ltd, Somerhill Business Park, Tonbridge, Kent, TN11 0GP
Imported into the EU by:
FKA Brands Ltd, 29 Earlsfort Terrace, Dublin 2, IE
Customer Support: +44(0)1732 378557 support@homedics.co.uk

COMPLIED STANDARDS LIST

Risk managementEN ISO 14971:20121 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 41:2013 Information supplied by the manufacturer of medical devices
General
Requirements for Safety
EN 60601-1:200641:2013412:2014/ IEC 60601-1:200541:2012 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 80601-2-30:200941:2013 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 81060-2:2013 Non-invasive sphygmomanometers – Part 2: Clinical validation of automated measurement type
UsabilityEN 60601-1-6:201041:2015/IEC 60601-1-6:201041:2013 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: 200641:2015 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

  1. This product needs special precautions regarding EMC and needs to be installed and put into service according to the EMC information provided, and this unit can be affected by portable and mobile RF communications equipment.
  2.  Do not use a mobile phone or other devices that emit electromagnetic fields, near the unit. This may result in incorrect operation of the unit.
  3. Caution: This unit has been thoroughly tested and inspected to assure proper performance and operation!
  4. Caution: This machine should not be used adjacent to or stacked with other equipment and if adjacent or stacked use is necessary, this machine should be observed to verify normal operation in the configuration in which it will be used.

Table 1

Guidance and manufacturer’s declaration — electromagnetic emission
Emission testCompliance
RF emissions CISPR 11Group 1
RF emission CISPR 11Class B
Harmonic emissions IEC 61000-3-2Class A
Voltage fluctuations/ flicker emissions IEC 61000-3-3Complies ALES

Table 2

Guidance and manufacturer’s declaration – electromagnetic emission
Immunity testIEC 60601 test levelCompliance level
Electrostatic
discharge (ESD) IEC 61000-4-2
±8 kV contact
±2 kV, ±4 kV, ±8 kV, ±15 kV, air
±8 kV contact
±2 kV, ±4 kV, ±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
IEC 61000-4-5
±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°. 070UT ; 1 cycle and 70%UT; 25/30 cycles. Single-phase: at 0°. 0% UT ; 300 cycle0%UT; 0.5 cycle. At 0°, 45°, 90°, 135°, 180°,225°,270°, and 315°. 070UT; 1 cycle and 70%UT; 25/30 cycles. Single-phase: at 0°. 0% UT ; 300 cycle
Power frequency magnetic field IEC 61000-4-830 A/m 50HzI60Hz30 A/m 50Hz/60Hz
Conducted 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
31/ 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 IEC61000-4-310 V/m
80 MHz- 2,7 GHz 80 % AM at 1 kHz
10 Vim
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 specifications for ENCLOSURE PORT IMMUNITY to RF wireless communications equipment)Test frequency (Mhz)Banda) (MHz)Service a)Modulation b)Modulation b) (W)Distance (m)IMMUNITY TEST LEVEL (V/m)
385380-390TETRA 400Pulse
modulation b) 18Hz
2.0.327
450430-470GMRS 460, FRS 460FM c) ± 5kHz deviation 1kHz sine20.328
9
710704-787LTE Band 13,17Pulse
modulation b) 217Hz
0.20.3
745
780
810800-960GSM
8001900,
TETRA 800, iDEN 820, CDMA 850, LTE Band 5
Pulse modulation b)
18 Hz
20.328
870
930
17201700-
1990
GSM 1800; CDMA 1900; GSM 1900; DECT;
LTE Band 1, 3,
4,25; UMTS
Pulse
modulation b) 217 Hz
20.328
28
1845
1970
24502400-
2570
Bluetooth, WLAN, 802.11 blg/n, RFID 2450, LTE Band 7Pulse
modulation 217 Hz
20.3
52405100-
5800
WLAN 802.11 a/nPulse
modulation 217 Hz
0.20.39
5500
5785

2 YEAR GUARANTEE
FKA Brands Ltd guarantees this product from defects in material and workmanship for a period of 2 years from the date of purchase, except as noted below. This FKA Brands Ltd product guarantee does not cover damage caused by misuse or abuse; accident; the attachment of any unauthorized accessory; alteration to the product; or any other conditions whatsoever that are beyond the control of FKA Brands Ltd. This guarantee is effective only if the product is purchased and operated in the UK / EU. A product that requires modification or adaptation to enable it to operate in any country other than the country for which it was designed, manufactured, approved, and/or authorized, or repair of products damaged by these modifications is not covered under this guarantee. FKA Brands Ltd shall not be responsible for any type of incidental, consequential or special damages. To obtain guaranteed service on your product, return the product post-paid to your local service center along with your dated sales receipt (as proof of purchase). Upon receipt, FKA Brands Ltd will repair or replace, as appropriate, your product and return it to you, post-paid. The guarantee is solely through Salter Service Centre. Service of this product by anyone other than the Salter Service Centre voids the guarantee. This guarantee does not affect your statutory rights. For your local Salter Service Centre, go to www.salterhousewares.co.uk/servicecentres

Guangdong Transtek Medical Electronics Co., Ltd.
Zone A, No 105, Dongli Road, Torch Development District,
Zhongshan, 528437, Guangdong, China

MDSS – Medical Device Safety Service GmbH
Schiffgraben 41, 30175 Hannover, Germany
Imported into the UK by:
FKA Brands Ltd, Somerhill Business Park, Tonbridge, Kent, TN11 0GP
Imported into the EU by:
FKA Brands Ltd, 29 Earlsfort Terrace, Dublin 2, IE
Customer Support: +44(0)1732 378557
support@homedics.co.uk
IB-BPA3020EU-1120-01
Version: 2.0

Documents / Resources

HoMEDiCS BPA-3020-EU Automatic Arm Blood Pressure Monitor [pdf] Instruction Manual
BPA-3020-EU Automatic Arm Blood Pressure Monitor, BPA-3020-EU, Automatic Arm Blood Pressure Monitor

References

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