Pearl Vena TMB-988 User manual

Version 1.0
Guangdong Transtek Medical Electronics Co., Ltd.
Zone B, No.105 ,Dongli Road, Torch Development
District, Zhongshan,528437,Guangdong,China
Thank you for choosing the Vena Blood Pressure
Monitor. To use the monitor correctly and safely,
please read the manual thoroughly. Please keep
this manual well in order to reference in future.
AVG
SYS
kPa mmHg
AVG
DIA
PM
Pul/min
START/STOP
SET
MEM
Vena
Blood Pressure Monitor
TMB-988 User Manual
Pearl ® Inc. 120-1231 Burdette Street,
Richmond BC Canada, V6V 2Z2
LifeWithPearl.com

INTRODUCTION
Safety Information
LCD Display Signal
Monitor Components
BEFORE YOU START
Installing and Replacing the Batteries
Setting Date, Time, Positioning Symbol and Measurement Unit
MEASUREMENT
Tie the Cuff
Start the Measurement
DATA MANAGEMENT
Recall the Records
Delete the Records
INFORMATION FOR USER
Tips for Measurement
Maintenance
ABOUT BLOOD PRESSURE
What are systolic pressure and diastolic pressure?
What is the standard blood pressure classification?
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 wrist?
TROUBLESHOOTING
SPECIFICATIONS
CONTACTINFORMATION
COMPLIED STANDARDS LIST
EMC GUIDANCE
2
8
11
13
15
17
20
19
21
21
22
23
General Description
Setting the User ID
Indications for Use
Measurement Principle
List
FCC STATEMENT
CONTENTS CONTENTS
1

General Description
CAUTION
Indications for Use
The Vena Blood Pressure Monitor is digital monitors intended for use
in measuring blood pressure and heartbeat rate with wrist circumference
ranging from 13.5cm to 21.5 cm ( about 5⅓˝-8½˝ ).
It is intended for adult indoor use only.
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.
The device also compares the longest and the shortest intervals of
detected pulse wave to with the average value, and then calculates the
standard deviation. The monitor will light up a warning symbol when the
calculated standard deviation is larger than or equal to 25%.
Measurement Principle
Safety Information
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”
SN
Symbol for “TYPE BF APPLIED
PARTS”
The signs below might be in the user manual, labeling or other component.
They are the requirement of standard and using.
Symbol for “THE OPERATION
GUIDE MUST BE READ”
Symbol for “MANUFACTURER”
Symbol for “SERIAL NUMBER”
Symbol for “DIRECT CURRENT”
Symbol for “MANUFACTURE
DATE”
Caution: These notes must be
observed to prevent any damage
to the device.
Symbol for “Recycle”
The Green Dot is the license
symbol of a European network of
industry-funded systems for
recycling the packaging materials
of consumer goods.
* 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 wrist or for functions
other than obtaining a blood pressure measurement.
* Do not confuse self-monitoring with self-diagnosis. This unit allows you to monitor
your blood pressure. Do not begin or end medical treatment without asking a
physician for treatment advice.
* If you are taking medication, consult your physician to determine the most
appropriate time to measure your blood pressure. Never change a prescribed
medication without consulting your physician.
* Do not take any therapeutic measures on the basis of a self measurement. Never
alter the dose of a medicine prescribed by a doctor. Consult your doctor if you have
any question about your blood pressure.
* When the device was used to measure patients who have common arrhythmias
such as atrial or ventricular premature beats or atrial fibrillation, the best result may
occur with deviation. Please consult your physician about the result.
* 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 wrist 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.
Thank you for selecting the VENA Blood Pressure Monitor TMB-988.
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 Vena 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:
Systolic blood pressure, Diastolic
blood pressure, Pulse rate, and up
to 60 groups of measuring records
3
2
INTRODUCTION INTRODUCTION

CAUTION
*Do not inflate the cuff on the samb limb which other monitoring ME equipment is
applied around simultaneously, because this could cause temporary loss of function of
those simultaneously-used monitoring ME equipment.
*On the rare occasion of a fault causing the cuff to remain fully inflated during
measurement, open the cuff immediately. Prolonged high pressure (cuff pressure ＞
300mmHg or constant pressure ＞ 15mmHg for more than 3 minutes) applied to the
wrist may lead to an ecchymosis.
*Please check that operation of the device does not result in prolonged impairment of
patient blood circulation.
* When measuring, 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 wrist 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 42.5℃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 data and change battery under normal circumstances and
maintain the device and its accessories according to the user manual.
* To avoid measurement errors, please avoid the condition of strong electromagnetic
field radiated interference signal or electrical fast transient/burst signal.
* The blood pressure monitor and the cuff are suitable for use within the patient
environment. If you are allergic to polyester, nylon or plastic, please don't use this
device.
* During use, the patient will be in contact with the cuff. The materials of the cuff have
been tested and found to comply with requirements of ISO 10993-5:2009 and ISO
10993-10:2010. It will not cause any potential sensization or irritation reaction.
* If you experience discomfort during a measurement, such as pain in the wrist or other
complaints, press the START/STOP button to release the air immediately from the cuff.
Loosen the cuff and remove it from your wrist.
* If the cuff pressure reaches 40 kPa (300 mmHg), the unit will automatically deflate.
Should the cuff not deflate when pressures reaches 40 kPa (300 mmHg), detach the
cuff from the wrist and press the START/STOP button to stop inflation.
* Before use, make sure the device functions safely and is in proper working condition.
Check the device, do not use the device if it is damaged in any way. The continuous
use of a damaged unit may cause injury, improper results, or serious danger.
* Do not wash the cuff in a washing machine or dishwasher!
* The service life of the cuff may vary by the frequency of washing, skin condition, and
storage state. The typical service life is 10000 times.
* It is recommended that the performance should be checked every 2 years and after
maintenance and repair, by retesting at least the requirements in limits of the error of
the cuff pressure indication and air leakage (testing at least at 50mmHg and
200mmHg).
* Please dispose of ACCESSORIES, detachable parts, and the ME EQUIPMENT
according to the local guidelines.
* Manufacturer will make available on request circuit diagrams, component part lists,
descriptions, calibration instructions,etc., to assist to service personnel in parts repair.
* The operator shall not touch output of batteries 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 Pearl. 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 Pearl if any unexpected operation or events occur.
* Keep the unit out of reach of infants, young children or pets to avoid inhalation or
swallowing of small parts. It is dangerous or even fatal.
* Be careful to strangulation due to cables and hoses, particularly due to excessive
length.
* At least 30 min required for ME equipment to warm from the minimum storage
temperature between uses until it is ready for intended use. At least 30 min required for
ME equipment to cool from the maximum storage temperature between uses until it is
ready for intended use.
* This equipment needs to be installed and put into service in accordance with the
information provided in the ACCOMPANYING DOCUMENTS;
* Wireless communications equipment such as wireless home network devices, mobile
phones, cordless telephones and their base stations, and walkie-talkies can affect this
equipment and should be kept at least a distance d away from the equipment. The
distance d is caculated by the MANUFACTURER from the 800 MHz to 2.5 GHz column
of Table 6 of IEC 60601-1-2:2007, as appropriate.
* Please use ACCESSORIES and detachable partes specified/ authorised by
MANUFACTURE. Otherwise, it may cause damage to the unit or danger to the
user/patients.
* There is no luer lock connectors are used in the construction of tubing, there is a
possibility that they might be inadvertently connected to intravascular fluid systems,
allowing air to be pumped into a blood vessel.
* Please use the device under the environment which was provided in the user manual.
Otherwise, the performance and lifetime of the device will be impacted and reduced.
CAUTION
4
INTRODUCTION INTRODUCTION
5

Systolic
blood pressure
Diastolic
blood pressure
mmHg Measurement unit the blood pressure
(1mmHg=0.133kPa)
kPa Measurement unit of the blood pressure
(1kPa=7.5mmHg)
Current time
Low battery Batteries are low and need to be replaced
LCD Display Signal
SYMBOL DESCRIPTION EXPLANATION
Month/Day,Hour/Minute
Indicates your maximum arterial pressure
Indicates your minimum arterial pressure
Pulse in beats per minute
Pulse display
Motion indicator Motion may result in an inaccurate
measurement.
Blood pressure monitor is detecting an
irregular heartbeat during measurement.
Irregular heartbeat
Blood pressure
level indicator Indicate the blood pressure level
Heartbeat Blood pressure monitor is detecting a
heartbeat during measurement.
Memory Indicate it is in the memory mode and
which group of memory it is.
CUFF
(Type BF applied part)
BATTERY
COMPARTMENT
Monitor Components
Component List:
1. PCBA;
2. Air Pipe;
3. Pump;
4. Valve;
5. Cuff.
List
1) Wrist Blood Pressure Monitor TMB-988
2) 2×AAA batteries
3) User manual
LCD DISPLAY
GRADE
TIME
SYSTOLIC
DIASTOLIC
MEM BUTTON
SET BUTTON
START/STOP BUTTON
PULSE RATE
7
INTRODUCTION
INTRODUCTION
6

• Slide off the battery cover.
•
• Replace the battery cover.
Installing and Replacing the Batteries
Replace the batteries whenever the below happen
The shows
The display is dim
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 batteries as indicated in the battery compartment.
Always use the correct battery type (2×AAA batteries).
Setting Date, Time and Measurement Unit
2.Press “MEM” button to change the numeral. Each press will increase
the numeral by one in a cycling manner.
1.When the monitor is off, press“SET” button, it will display the time. Then
hold pressing “SET” for 3 seconds to enter the mode for year setting.
3.When you get the right year, press “SET” button to confirm and it will
turn to next step.
It is important to set the clock before using your blood
pressure monitor, so that a time stamp can be assigned to
each record that is stored in the memory.
(The setting range of year: 2010~2050, time format: 24H/12H)
8 9
BEFORE YOU STARTBEFORE YOU START

Tie the Cuff
1.
2.
3.
4.
5.
Remove all accessories (watch, bracelet,etc) from your wrist. If your
physician has diagnosed you with poor circulation in one wrist, use the
other wrist for blood pressure measurement.
Roll or push up your sleeve to expose the skin.
Apply the cuff to your wrist with your palm facing up.
Position the edge of the cuff about 1cm~1.5cm from wrist joints.
Fasten the wrist cuff around your wrist, 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 wrist 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.
Patients with Hypertension:
The middle of the cuff should be at the level of the right atrium of the
heart; Before starting measurement, please sit comfortably with legs
uncrossed, feet flat on the floor, back and wrist supported.
Rest for 5 minutes before measuring.
Wait at least 3 minutes between measurements. This allows your blood
circulation to recover.
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 wrist, or as directed by a physician.
6.
7.
Take the measurement in a silent room.
The cuff should be at the same level as your heart.
Do not cross your legs and keep your feet on the ground.
Keep your back against the backrest of the chair.
4.Repeat steps 2 and 3 to confirm [MONTH] and [DAY].
5.Then the monitor diverts to time setting. Select the time format.
Repeat steps 2 and 3 to confirm the time format , [HOUR] and [MINUTE].
6.Repeat steps 2 and 3 to confirm the measurement unit.
7.After confirming the meausrement unit, the LCD will
display all the settings you have done one by one and then
the monitor will shut off.
10 11
BEFORE YOU START MEASUREMENT

1.When the monitor is off, press
START/STOP button to turn on
the monitor, and it will finish the
whole measurement.
Start the Measurement
2.Press START/STOP button to power off,
otherwise it will turn off within 1 minute.
Recall the Records
1.
2.
CAUTION
When the monitor is off, press “MEM” button to show the
latest measurement record.
Press “MEM” button or “SET” button to get the record you want.
The most recent record (1) is shown first. Each new measurement is
assigned to the first (1) record. All other records are pushed back one
digit (e.g., 2 becomes 3, and so on), and the last record (60) is dropped
from the list.
Adjust the zero.
LCD display
Inflating and measuring. Display and save the
result.
UP
DOWN
The corresponding
time is 10:38.
The corresponding
date is 5th January.
The date and time will
display alternately.
1312
DATA MANAGEMENTMEASUREMENT

1514
DATA MANAGEMENT
1.
If you did not get the correct measurement, you can delete all
results by following steps below .
Delete the Records
3.If there is no record,
the right display will
be shown.
In the memory mode, hold
pressing “MEM” button for
3 seconds, the flash display
“dEL ALL” will show.
Note: To exit out of delete
mode without deleting any
records, press “START/STOP”
button before pressing "SET"
button to confirm any delete
commands.
2. Press “SET” button to confirm
deleting, the LCD will display
“dEL dOnE” and then turn off.
Tips for Measurement
Measurements may be inaccurate if taken in the following
circumstances.
Within 1 hour after eating
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
INFORMATION FOR USER

Maintenance
In order to get the best performance, please follow the
instructions below.
Store in a dry place and avoid
direct sunlight
Avoid intense shaking
and collisions
Use wet cloths to remove dirt
Avoid contact with water, clean
it with a dry cloth
Avoid dusty and unstable
temperature environment
Avoid washing the cuff
1716
ABOUT BLOOD PRESSURE
INFORMATION FOR USER
When ventricles contract and pump blood
out of the heart, blood pressure reaches its
maximum value, the highest pressure in the
cycle is known as systolic pressure. When
the heart relaxes between heartbeats, the
lowest blood pressure is diastolic pressure.
What are systolic pressure and diastolic pressure?
What is the standard blood pressure classication?
press
artery vein
blood discharging
Systolic
relax
blood entering
Diastolic
CAUTION
Irregular Heartbeat Detector
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.
The chart on the right is the
standard blood pressure classifi-
cation published by American
Heart Association (AHA).
Please consult a physician if your measuring result falls outside the range.
Please note that only a physician can tell whether your blood pressure value
has reached a dangerous point.
CAUTION
Blood Pressure Category
Normal
Prehypertension
High Blood Pressure
(Hypertension) Stage 1
High Blood Pressure
(Hypertension) Stage 2
Hypertensive Crisis
(Emergency care needed)
Systolic
mmHg (upper#)
Diastolic
mmHg (lower#)
less than 120
120-129
130-139
140 or higher
Higher than 180
and
or
or
and/or
less than 80
80-89
90 or higher
Higher than 120
This chart reflects blood pressure categories defined by American Heart Association.
An irregular heartbeat ( IHB) is detected when a heartbeat rhythm varies while
the unit is measuring the systolic and diastolic blood pressure. During each
measurement, the monitor records the heartbeat intervals and calculates the
average. If any average is larger than or equal to 25%,the irregular heartbeat
symbol will appear on the display.
and less than 80

This section includes a list of error messages and frequently
asked questions for problems you may encounter with your wrist
blood pressure monitor. If the products not operating as you
think it should, check here before arranging for servicing.
PROBLEM SYMPTOM CHECK THIS REMEDY
No power
Low
batteries
Error
message
Display is dim or
will not light up.
Batteries are exhausted. Replace with new batteries
Insert the batteries
correctly
Replace with new batteries
Batteries are inserted
incorrectly.
Show on
the display Batteries are low.
E 1 shows The cuff is not secure. Refasten the cuff and then
measure again.
E 2 shows The cuff is very tight Refasten the cuff and then
measure again.
E 3 shows The pressure of the
cuff is excessive.
Relax for a moment
and then measure again.
E 10 or
E 11 shows
The monitor detected
motion while measuring.
Movement can affect the
measurement.Relax for a
moment and then
measure again.
E 20 shows
E 21 shows 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.
The measurement
process does not detect
the pulse signal.
Loosen the clothing on
the wrist and then
measure again.
Measure incorrectly.
1918
ABOUT BLOOD PRESSURE TROUBLESHOOTING
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.
Why do I get a different blood pressure
at home compared to the hospital?
The blood pressure differs throughout the day due to weather,
emotion, exercise etc. There is the “white coat” effect, which means
blood pressure can increase in clinical settings.
If the cuff is secured properly.
If the cuff is too tight or too loose.
If the cuff is tied on the wrist.
If you feel anxious.
Taking 2-3 deep breaths before
beginning will calm you down and
improve measurement.
Is the result the same if measuring
on the right wrist?
It is ok for both wrists, but there will be varying results for different
people. We suggest you measure the same wrist every time.
Why does my blood pressure
uctuate throughout the day?
What you need to pay
attention to when you
measure your blood
pressure at home:

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
Power supply Battery powered mode:
2*AAA batteries (3V DC)
Display mode Digital LCD V.A.35mm×41mm
Measurement mode Oscillographic testing mode
Measurement range
Accuracy
Normal working condition
Storage & transportation
condition
Measurement perimeter
of the wrist
About 13.5cm-21.5cm
Net Weight Approx.100g(Excluding the dry cells)
External dimensions
Attachment
Approx.73mmx67.5mmx22.5mm
2*AAA batteries,user manual
Mode of operation Continuous operation
Degree of protection Type BF applied part
Protection against
ingress of water
Software version
Device classification
V01
Internally Powered ME Equipment
WARNING: No modification of this equipment is allowed.
Temperature:5℃to 40℃
Relative humidity: ≤85%RH
Atmospheric pressure: 86kPa to 106kPa
Temperature:-20℃to 60℃
Relative humidity: 10%RH to 93%RH
Atmospheric pressure: 50kPa to 106kPa
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.
Contact Information
For more information about our products, please visit
Company:
Address: 120-1231 Burdette Street, Richmond BC, V6V 2Z2
PEARL® Inc.
www.LifeWithPearl.com
2120
SPECIFICATIONS CONTACT INFORMATION

Complied Standards List
EN ISO 14971:2012 / ISO 14971:2007 Medical devices -
Application of risk management to medical devices
EN 1041:2008 Information supplied by the manufacturer of medical
devices
EN 60601-1:2006/ IEC 60601-1:2005+A1:2012 Medical electrical
equipment - Part 1: General requirements for basic safety and
essential performance
EN 60601-1-11:2010/ 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 60601-1-2:2007/ IEC 60601-1-2:2007 Medical electrical
equipment - Part 1-2: General requirements for basic safety and
essential performance - Collateral standard: Electromagnetic
compatibility - Requirements and tests
EN ISO 81060-1:2012 Non-invasive sphygmomanometers - Part 1:
Requirements and test methods for non-automated measurement type
EN 1060-3:1997+A2:2009 Non-invasive sphygmomanometers -
Part 3: Supplementary requirements for electro-mechanical blood
pressure measuring systems
EN 1060-4:2004 Non-invasive sphygmomanometers - Part 4: Test
procedures to determine the overall system accuracy of automated
non-invasive sphygmomanometers
EN 60601-1-6:2010/IEC 60601-1-6:2010+A1:2013 Medical
electrical equipment - Part 1-6: General requirements for basic safety
and essential performance - Collateral standard: Usability
EN 62366:2008/ IEC 62366-1:2015 Medical devices - Application
of usability engineering to medical devices
EN 62304:2006/AC: 2008 / IEC 62304:2006 Medical device
software - Software life-cycle processes
Risk management
Labeling
User manual
General Requirements
for Safety
Electromagnetic
compatibility
Performance
requirements
Clinical investigation
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
EN 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
IEC 80601-2-30:2013 Medical electrical equipment- Part 2-30:
Particular requirements for the basic safety and essential
performance of automated non-invasive sphygmomanometers
ISO 81060-2:2013 Non-invasive sphygmomanometers - Part 2:
Clinical validation of automated measurement type
EMC Guidance
Table 1 Guidance and MANUFACTURER’s declaration – ELECTROMAGNETIC
EMISSIONS- for all ME EQUIPMENT and ME SYSTEMS
Guidance and manufacturer’sdeclaration – electromagnetic emissions
RF emissions
CISPR 11 Group 1
Class B
Not applicable
Not applicable
Compliance
The device is intended for use in the electromagnetic environment specified
below. The customer or the user of the device should assure that it is used in
such an environment.
Harmonic emissions
IEC 61000-3-2
Voltage fluctuations/
flicker emissions IEC
61000-3-3
RF emissions
CISPR 11
Emissions test Electromagnetic environment - guidance
The device uses RF energy only for its
internal function. Therefore, its RF
emissions are very low and are not likely
to cause any interference in nearby
electronic equipment.
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 that 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.
The device is suitable for use in all establishments,
including domestic establishments and those directly
connected to the public low-voltage power supply
network that supplies buildings used for domestic
purposes.
2322
EMC GUIDANCECOMPLIED STANDARDS LIST

Guidance and manufacturer’s declaration – electromagnetic immunity
IMMUNITY test
±6 kV contact
±8 kV air ±6 kV contact
±8 kV air
±2 kV for
power supply lines Not applicable
±1 kV line(s)
to line(s)
±2 kV line(s)
to earth
<5% UT
(>95% dip in UT)
for 0.5 cycle
40% UT
(60% dip in UT)
for5cycles
70% UT
(30% dip in UT)
for 25 cycles
<5% UT
(>95% dip in UT)
for 5 s
3A/m
NOTE UT is the a.c. mains voltage prior to application of the test level.
Table 2 Guidance and MANUFACTURER’s declaration – electromagnetic
IMMUNITY – for all ME EQUIPMENT and ME SYSTEMS
IEC 60601 test level Compliance level
Electrostatic
discharge (ESD)
IEC 61000-4-2
Electromagnetic
environment - guidance
Floors should be wood,
concrete or ceramic tile. If
floors are covered with
synthetic material, the
relative humidity should be
at least 30%.
Power frequency magnetic
fields should be at levels
characteristic of a typical
location in a typical
commercial or hospital
environment.
3A/m
Power frequency
(50/60Hz)
magnetic field
IEC 61000-4-8
Voltage dips,
short interruptions
and voltage
variations on
power supply
input lines
IEC 61000-4-11
Electrical fast
transient/burst
IEC 61000-4-4
Surge IEC
61000-4-5
The device is intended for use in the electromagnetic environment specified below.
The customer or the user of the device should assure that it is used in such an
environment
±1 kV for
input/output lines
Not applicable
Not applicable
Mains power quality should
be that of a typical
commercial or hospital
environment.
Mains power quality should
be that of a typical
commercial or hospital
environment.
Mains power quality should
be that of a typical
commercial or hospital
environment. If the user of
the device requires
continued operation during
power mains interruptions,
it is recommended that the
device be powered from an
uninterruptible power supply
or a battery.
Table 4 Guidance and MANUFACTURER’s declaration – electromagnetic IMMUNITY –
for ME EQUIPMENT and ME SYSTEMS that are not LIFE-SUPPORTING
Guidance and manufacturer’s declaration – electromagnetic immunity
IMMUNITY test
Not applicable
3 V/m
Compliance
level
IEC 60601
TEST LEVEL
Conducted RF
IEC 61000-4-6
Radiated RF
IEC 61000-4-3
3 V/m
80 MHz to
2.5 GHz
3 Vrms
150 kHz to
80 MHz
Electromagnetic environment -
guidance
Portable and mobile RF communications
equipment should be used no closer to
any part of the device, including
cables, than the recommended
separation distance calculated from the
equation applicable to the frequency of
the transmitter.
Recommended separation distance
The device is intended for use in the electromagnetic environment specified below.
The customer or the user of the device should assure that it is used in such an environment.
where P is the maximum output power
rating of the transmitter in watts (W)
according to the transmitter manufacturer
and dis the recommended separation
distance in metres (m).
Field strengths from fixed RF
transmitters, as determined by an
electromagnetic site survey, should be
less than the compliance level in each
frequency range.
a
b
Interference may occur in the vicinity of
equipment marked with the following
symbol:
P
=d
P
=d
80 MHz to 800 MHz
P
=d 2,3
800 MH z to 2,5 GH z
1,2
NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic
propagation is affected by absorption and reflection from structures, objects
and people.
a
Field strengths from fixed transmitters, such as base stations for radio (cellular / cordless) telephones
and land mobile radios, amateur radio, AM and FM radio broad-cast and TV broadcast cannot be
predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF
transmitters, an electromagnetic site survey should be considered. If the measured field strength in
the location in which the device is used exceeds the applicable RF compliance level above, the
device should be observed to verify normal operation. If abnormal performance is observed,
additional measures may be necessary, such as re-orienting or relocating the device.
Over the frequency range 150 kHz to 80 MHz, field strengths should be less than
3V/m.
b
1,2
2524
EMC GUIDANCEEMC GUIDANCE

EMC GUIDANCE
150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2.5 GHz
Table 6 Recommended separation distances between portable and mobile
RF communications equipment and the ME EQUIPMENT or ME SYSTEM –
for ME EQUIPMENT and ME SYSTEMS that are not LIFE-SUPPORTING
Recommended separation distances
between portable and mobile RF communications equipment and the device.
The device is intended for use in an electromagnetic environment in which
radiated RF disturbances are controlled. The customer or the user of the device
can help prevent electromagnetic interference by maintaining a minimum distance
between portable and mobile RF communications equipment (transmittters) and the
device as recommended below, according to the maximum output power of the
communications equipment.
Rated maximum output
power of transmitter
(W)
Separation distance according to frequency of transmitter (m)
For transmitters rated at a maximum output power not listed above, the recommended
separation distance d in metres (m) can be estimated using the equation applicable to
the frequency of the transmitter, where Pis the maximum output power rating of the
transmitter in watts (W) according to the transmitter manufacturer.
NOTE 1 At 80MHz and 800MHz, the separation distance for the higher frequency
range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation
is affected by absorption and reflection from structures, objects and people.
0.01
0.1
1
10
100
0.12 0.12
0.38
1.2
3.8
12
0.23
0.73
2.3
7.3
23
=d P
=d 1,2 2,3 P
=d
0.38
1.2
3.8
12
P
1,2
25