Samsung ARM BPM User manual

Guangdong Transtek Medical Electronics Co., Ltd.
Zone A, No.105 ,Dongli Road, Torch Development District,
Zhongshan,528437,Guangdong,China
EC REP
version:1.0
User Manual
SAMSUNG ARM BPM EI-B5000
Thank you very much for selecting SAMSUNG ARM BPM EI-B5000.
To use the monitor correctly and safely, please read the manual thoroughly.
Please keep well this manual in order to reference in future.
Arm Type
CATALOGUE
Table of Contents
INTRODUCTION...................................................................................................................2
General Description
Indications for Use
Contraindications
Measurement Principle
Safety Information
LED Display Signal
Components of the Device
List
BEFORE YOU START...........................................................................................................8
The Choice of Power Supply
Installing and Replacing the Batteries
Install the App and Pair-Up
Search your test information
D
MEASUREMENT..................................................................................................................11
Tie the Cuff
Taking a Measurement
INFORMATION FOR USER.................................................................................................14
Tips for measurement
Maintenances
ABOUT BLOOD PRESSURE...............................................................................................16
What are systolic pressure and diastolic pressure?
What is the standard blood pressure classification?
Irregular heartbeat detector
Why does my blood pressure fluctuate throughout the day?
Why do I get a different blood pressure at home compared to the hospital?
Is the result the same if measuring on the right arm?
TROUBLESHOOTING.........................................................................................................18
SPECIFICATIONS................................................................................................................19
CONTACT INFORMATION...................................................................................................20
FCC STATEMENT...................................................................................................
COMPLIED STANDARDS LIST...........................................................................................21
EMC GUIDANCE.................................................................................................................22
CATALOGUE
1

Thank you for selecting arm type SAMSUNG ARM BPM ( EI-B5000 ). The
monitor features blood pressure measurement, pulse rate measurement and
the 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, step-by-step
instructions for using the product, please read it thoroughly before using.
Features:
Up to 60 pieces of record stored for each user
3rd technology: Measuring during inflation
General Description
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 deter-
mine the systolic pressure and diastolic pressure as well as pulse rate.
Measurement Principle
Indications for Use
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, defibrillators.
The signs below might be in the user manual, labeling or other components.
They are the requirement of standard and using.
Safety Information
The SAMSUNG ARM BPM is digital monitors intended for use
in measuring blood pressure and heartbeat rate with arm circumference
ranging from 22cm to 42cm(about 8¾˝-16½˝).
It is intended for adult indoor use only.
Symbol for “RECYCLE”
Symbol for “THE OPERATION
GUIDE MUST BE READ”
Symbol for “MANUFACTURER”
Symbol for “SERIAL NUMBER”
Symbol for “TYPE BF APPLIED
PARTS”
Symbol for “DIRECT CURRENT”
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”
Caution: These notes must
be observed to prevent any
damage to the device.
SN
Symbol for “MANUFACTURE
DATE”
Symbol for “Authorised Representative
in the European Community
EC REP
CAUTION
* This device is intended for adult use in homes only.
* The device is not suitable for use on neonatal patients, pregnant women,patients with
implanted, electronical devices, patients with pre-eclampsia, premature ventricular beats,
atrial fibrillation, peripheral, arterial disease and patients undergoing intravascular therapy or
arterio-venous shunt or people who received a mastectomy. Please consult your doctor prior
to using the unit if you suffer from illnesses.
* The device is not suitable for measuring the blood pressure of children. Ask your doctor
before using it on older children.
* The device is not intended for patient transport outside a healthcare facility.
* The device is not intended for public use.
* This device is intended for no-invasive measuring and monitoring of arterial blood pressure.
It is not intended for use on extremities other than the arm or for functions other than
obtaining a blood pressure measurement.
* Do not confuse self-monitoring with self-diagnosis. This unit allows you to monitor your
blood pressure.Do not begin or end medical treatment without asking a physician for
treatment advice.
* If you are taking medication,consult your physician to determine the most appropriate time
to measure your blood pressure. Never change a prescribed medication without consulting
your physician.
* Do not take any therapeutic measures on the basis of a self measurement. Never alter the
dose of a medicine prescribed by a doctor. Consult your doctor if you have any question
about your blood pressure.
* When the device 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.
23
INTRODUCTION INTRODUCTION

CAUTION
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 cause harmful injury to the
patient: connection tubing kinking too frequent and consecutive multiple measurements; the
application of the cuff and its pressurization on any arm where intravascular access or
therapy, or an arterio-venous (A-V) shunt, is present; inflating the cuff on the side of a
mastectomy.
* Warning: Do not apply the cuff over a wound;otherwise it can cause further injury.
*Do not inflate the cuff on the same limb which other monitoring ME equipment is applied
around simultaneously, because this could cause temporary loss of function of those
simultaneously-used monitoring ME equipment.
*On the rare occasion of a fault causing the cuff to remain fully inflated during measurement,
open the cuff immediately. Prolonged high pressure (cuff pressure ＞300mmHg or constant
pressure ＞ 15mmHg for more than 3 minutes) applied to the arm may lead to an
ecchymosis.
*Please check that operation of the device does not result in prolonged impairment of patient
blood circulation.
* When measurement, please avoid compression or restriction of the connection tubing.
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 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 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 with oxygen or nitrous oxide.
* Warning: No servicing/maintenance while the ME equipment is in use.
* The patient is an intended operator.
* The patient can measure, and charge power under normal circumstances and maintain the
* The service life of the cuff may vary by the frequency of washing, skin condition, and
storage state. The typical service life is 10000 times.
* It is recommended that the performance should be checked every 2 years and after
maintenance and repair, by retesting at least the requirements in limits of the error of the
cuff pressure indication and air leakage (testing at least at 50mmHg and 200mmHg).
* Please dispose of ACCESSORIES, detachable parts, and the ME EQUIPMENT according
to the local guidelines.
* Manufacturer will make available on request circuit diagrams, component part lists,
descriptions, calibration instructions,etc., to assist to service personnel in parts repair.
* The plug/adapter plug pins 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 operation of ME equipment.
* The operator shall not touch output of batteries /adapter and the patient simultaneously.
* Cleaning :Dust environment may affect the performance of the unit. Please use the soft
cloth to clean the whole unit before and after use. Don’t use any abrasive or volatile
cleaners.
* The device doesn’t need to be calibrated within two years of reliable service.
* If you have any problems with this device, such as setting up, maintaining or using, please
contact the SERVICE PERSONNEL of 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 operation or events occur.
CAUTION
device and its accessories according to the user manual.
* To avoid measurement errors, please avoid the condition of strong electromagnetic field
radiated interference signal or electrical fast transient/burst signal.
* The blood pressure monitor, and the cuff are suitable for use within the patient
environment. If you are allergic to polyester, nylon or plastic, please don't use this device.
* During use, the patient will be in contact with the cuff. The materials of the cuff have been
tested and found to comply with requirements of ISO 10993-5:2009 and ISO 10993-10:2010.
It will not cause any potential sensation or irritation reaction.
* Adaptor is specified as a part of ME EQUIPMENT.
* If you experience discomfort during a measurement, 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 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!
45
INTRODUCTION INTRODUCTION

LED Display Signal
SYMBOL DESCRIPTION
Systolic blood pressure High pressure result
Diastolic blood pressure Low pressure result
EXPLANATION
Pulse Pulse/minute
Installing and Replacing the Batteries
START/STOP BUTTON
Components of the Device
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.
SYS DIA HR
HR
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 intended use. At least 30 min required for ME equipment to
cool from the maximum storage temperature between uses until it is ready for intended use.
* This equipment needs to be installed and put into service in accordance with the
information provided in the ACCOMPANYING DOCUMENTS;
* Wireless communications equipment such as wireless home network devices, mobile
phones, cordless telephones and their base stations, walkie-talkies can affect this
equipment and should be kept at least a distance d away from the equipment. The distance
d is calculated by the MANUFACTURER from the 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/ authorised by
MANUFACTURE. Otherwise, it may cause damage to the unit or danger to the
user/patients.
* There is no luer lock connectors are used in the construction of tubing, there is a possibility
that they might be inadvertently connected to intravascular fluid systems, allowing air to be
pumped into a blood vessel.
* Please use the device under the environment which is provided in the user manual.
Otherwise, the performance and lifetime of the device will be impacted and reduced.
Component list of
pressure measuring system:
1 Cuff
2 Air pipe
3 PCBA
4 Pump
5 Valve
List
1. SAMSUNG ARM BPM
(EI-B5000)
3. User manual 4. 4*AAA batteries
2. Cuff (22~42cm)
(Type BF applied part)
The Choice of Power Supply
1. Battery powered mode:
6VDC 4*AAA batteries
In order to get the best effect and protect your monitor,please use the
the right batteries and special power adapter which complies with local
safety standard.
CAUTION
7
6
INTRODUCTIONINTRODUCTION
BATTERY COMPARTMENT
BATTERY DOOR

Replace the batteries whenever the below happens
The symbol 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 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.
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”.
Click , choose “Accessories”, click “Scan for accessories” and add “Samsung
Arm Bpm”
After the measurement is finished, the message will be sent to app
automatically, click to check your test history.
Search your test information
9
8
BEFORE YOU START
BEFORE YOU START

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
1.
2.
Interference may occur in the vicinity of equipment marked with the following
symbol . And EI-B5000 may interfering 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
Bluetooth end at 2.4 GHz.
How to mitigate possible interference?
The range between the device and BT end should be reasonably close, from
1 meter to 10 meters. Please ensure no obstacles between the device and
BT end so as to obtain quality connection and to lower the RF output range.
To avoid interference, other electronic devices (particularly those with
wireless transmission / Transmitter) should be kept at least 1 meter away
from the monitor.
RF Frequency Range: 2402MHz to 2480MHz
Output Power Range: ≤ 0 dBm
Supply Voltage: 4.0-7.2V
Transmitting Distance: 10 meters
Settinging 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 agin to switch the user. There are 3 user intotal and guest mode.
(User mode store 60 grops message, guest mode doesn’t store message.
START/STOP BUTTON
SYS DIA HR SYS DIA HR
SYS DIA HR
SYS DIA HR
MEASUREMENT
11
10
BEFORE YOU START
11
Tie the Cuff
1.
2.
3.
4.
5.
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.
Roll or push up your sleeve to expose the skin.
Apply the cuff to your arm with your palm facing up.
Position the edge of the cuff about 2cm~3cm from elbow.
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.
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.
Rest for 5 minutes before first measurement.
Wait at least 3 minutes between measurements. This allows your blood circulation to
recover.
6.
7. Helpful tips for Patients, especially for Patients with Hypertension:

1. After setting the User, press the
“START/STOP” button again, and
then the monitor will complete the
measurement automatically.
Ready for measurement Inflating and measuring.
Taking a Measurement
START/STOP BUTTON
SYS DIA HR SYS DIA HR
SYS DIA HR SYS DIA HR
After the measurement was finished, the Systolic pressure, Diastolic
pressure and heart rate will show up alternately
The patient must relax as much as possible and do not move and talk during the
measurement procedure.
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.
Take the measurement in a silent room.
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.
Tip:
You can press “ START/STOP ” button at any time to stop measuring
during the process of measurement.
2. This device will proceed to data
transmission automatically after
measurement.
If the data transmission fails, the monitor will turn off automatically.
SYS DIA HR
SYS DIA HR
3.If the data is successfully
transmitted, the LCD will
display and then the
device will turn off.
SYS DIA HR
MEASUREMENT MEASUREMENT
13
12

Tips for Measurement
Measurements may be inaccurate if taken in the following
circumstances.
Within 1 hour
after dinner or drinking
Within 20 minutes
after taking a bath
In a very cold environment
Immediate measurement
after tea, coffee, smoking
When talking or moving your fingers
When you want to discharge urine
Maintenance
In order to get the best performance, please follow the
instructions below.
Put in a dry place and avoid the sunshine
Avoid intense shaking
and collisions
Using wet cloths to remove dirt
Avoid touching water,
clean it with a dry cloth in case.
Avoid dusty and unstable
temperature environment
Avoid washing the cuff
15
14
INFORMATION FOR USER INFORMATION FOR USER

What are systolic pressure and diastolic pressure?
press
artery vein
blood discharging
Systolic
relax
blood entering
Diastolic
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.
Irregular Heartbeat Detector
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.
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.
Why does my blood
pressure fluctuate
throughout the day?
Is the result the same
if measuring on the
right arm?
Why do I get a different
blood pressure at home
compared to the hospital?
1. Individual blood pressure varies
multiple times everyday. It is also affected
by the way you tie your cuff and your
measurement position, so please take the
measurement under the same conditions.
2.If the person takes medicine, the
pressure will vary more.
3.Wait at least 3 minutes for another
measurement.
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.
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.
What is the standard blood pressure classification?
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.
The blood pressure classification published by
World Health Organization (WHO) and
International Society of Hypertension (ISH) in
1999 is as follows:
CAUTION
SYS
DIA
<120
<80
120-129
80-84
130-139
85-89
140-159
90-99
160-179
100-109
≥180
≥110
Level
Blood
Pressure (mm Hg)
Optimal Normal High-normal Mild Moderate Severe
17
16
ABOUT BLOOD PRESSUREABOUT BLOOD PRESSURE

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 it
should, check here before arranging for servicing.
Approx.285g(Excluding the batteries)
Approx.159mm*50mm*27mm
4×AAA batteries,user manual
Battery powered mode: 6VDC 4×AAA batteries
About 22cm~42cm
Type BF applied part
WARNING: No modification of this equipment is allowed.
Power supply
Measurement mode
Oscillographic testing mode
Measurement range
Measurement perimeter
of the upper arm
Weight
External dimensions
Attachment
Mode of operation
Continuous operation
Degree of protection
Protection against
ingress of water
Accuracy
Normal working condition
Storage & transportation
condition
Software Version
Pressure:
5°C-40°C within ± 3mmHg (0.4kPa)
Pulse value: ±5%
Rated cuff pressure:
0mmHg~299mmHg (0kPa ~ 39.9kPa)
Measurement pressure:
SYS: 60mmHg~230mmHg (8.0kPa~30.7kPa)
DIA: 40mmHg~130mmHg (5.3kPa~17.3kPa)
Pulse value: (40-199)beat/minute
Device Classification
Battery Powered Mode:
Internally Powered ME Equipment
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
Temperature: -20°C to +60°C
A relative humidity range of ≤ 93%, non-condensing,
at a water vapour pressure up to 50hPa
A01
PROBLEM SYMPTOM CHECK THIS REMEDY
No power
or Low
batteries
Error
message
Display
will not light up Batteries are exhausted. Replace with new batteries
Insert the batteries
correctly
Batteries are inserted
incorrectly.
E 01 shows
E 02 shows
E 03 shows
Movement can affect the
measurement. Relax for a
moment and then
measure again.
E 04 shows
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.
or
shows
The monitor detected
motion, talking or the
pluse is too poor
while measuring.
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.
Refasten the cuff and then
measure again.
The measurement
process does not detect
the pulse signal.
Loosen the clothing on the
arm and then measure
again
The treatment of the
measurement failed. Relax for a moment and then measure again.
The cuff is not secure
or Inflatable abnormal.
IP22: The first number 2: Protected against solid
foreign objects of 12,5mm Ф and greater. The
second number: Protected against vertically falling
water drops when enclosure titled up to 15º.
Vertically falling drops shall have no harmful effects
when the enclosure is titled at any angle up to 15º on
either side of the vertical
19
18
TROUBLESHOOTING SPECIFICATIONS

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:
Company:
Address:
Guangdong Transtek Medical Electronics Co., Ltd.
Zone A, No.105, Dongli Road, Torch Development District,
Zhongshan,528437,Guangdong,China
Guangdong Transtek Medical Electronics Co., Ltd.
EC REP
Complied Standards List
EN ISO 14971:2012 / ISO 14971:2007 Medical devices - Application
of risk management to medical devices
EN 1041:2008 +A1:2013 Information supplied by the manufacturer of
medical devices
EN 60601-1:2006+A1:2013/ IEC 60601-1:2005+A1:2012 Medical
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
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
EN 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
EN 1060-4:2004 Non-invasive sphygmomanometers - Part 4: Test
procedures to determine the overall system accuracy of automated
non-invasive sphygmomanometers
ISO 81060-2:2018 Non-invasive sphygmomanometers - Part 2:
Clinical validation of intermittent automated measurement type
Risk management
Labeling
User manual
General Requirements
for Safety
Electromagnetic
compatibility
Performance
requirements
Clinical investigation
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
21
20
Contact Information COMPLIED STANDARDS LIST
FCC Statement
This device complies with Part 15 of the FCC Rules. Operation is subject to
the 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:
contains FCC ID：OU9TMB207401
-- 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.

23
22
EMC GUIDANCE
EMC GUIDANCE
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
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
RF emissions
CISPR 11 Group 1
Class B
Not applicable
Compliance
Harmonic emissions
IEC 61000-3-2
Voltage fluctuations/
flicker emissions
IEC 61000-3-3
RF emissions
CISPR 11
Emissions test
Not applicable
Table 2
Guidance and manufacturer’s declaration – electromagnetic Immunity
Immunity Test
±8 kV contact
±2 kV, ±4kV, ±8 kV, ±15 kV air ±8 kV contact
Compliance level
Electrostatic
discharge (ESD)
IEC 61000-4-2
Electrical fast
transient/burst
IEC 61000-4-4
Surge
IEC61000-4-5
IEC 60601-1-2
Test level
±2 kV, ±4kV, ±8 kV, ±15 kV air
Not applicable
Not applicable Not applicable
Not applicable
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
EN 62304:2006/AC: 2008 / IEC 62304: 2006+A1:2015 Medical
device software - Software life-cycle processes
Usability
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

25
24
EMC GUIDANCE EMC GUIDANCE
810
870
930
800-960
GSM
800/900,
TETRA 800,
iDEN 820,
CDMA 850,
LTE Band 5
Pulse
modulation b)
18Hz
20.3 28
1720
1845
1970
1700-
1990
GSM 1800;
CDMA 1900;
GSM 1900;
DECT;
LTE Band 1,
3,
4,25; UMTS
Pulse
modulation b)
217Hz
20.3 28
20.3 282450 2400-
2570
Bluetooth,
WLAN,
802.11
b/g/n, RFID
2450, LTE
Band 7
Pulse
modulation
217 Hz
5240
5500
5785
5100-
5800 WLAN 802.11
a/n
Pulse
modulation
217 Hz
0.2 0.3 9
30 A/m
50Hz/60Hz
NOTE U
T
is the a.c. mains voltage prior to application of the test level.
30 A/m
50Hz/60Hz
Power frequency
magnetic field
IEC 61000-4-8
Voltage dips, short
interruptions and
voltage variations
on power supply
input lines
IEC 61000-4-11
Conduced RF
IEC61000-4-6
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
Radiated RF
IEC61000-4-3
Not applicable Not applicable
Not applicable Not applicable
Table 3
Guidance and manufacturer’s declaration - electromagnetic Immunity
Test
Frequency
(MHz)
385 0.3 27
Radiated RF
IEC61000-4-3
(Test
specifications
for
ENCLOSURE
PORT
IMMUNITY to
RF wireless
communicatio
ns equipment)
Band
(MHz)
Service Modulation Modulation
(W)
Distance (m)
IMMUNITY
TEST
LEVEL
(V/m)
380-390 TETRA
400 Pulse modulation b)
18Hz
1.8
450 430-470
GMRS 460，
FRS 460
FM c) ± 5kHz
deviation 1kHz
sine
20.3 28
710 704-787
745
780
LTE Band
13,17 Pulse modulation b)
217Hz 0.2 0.3 9