version:1.0
GUANGDONG TRANSTEK MEDICAL ELECTRONICS CO., LTD
Zone A, 5/F., Investment Building, No. 12, Huizhan East Rd., Torch
Development District, Zhongshan, Guangdong, 528437, China
EC REP
User Manual
Blood Pressure Monitor
TMB-1490
Arm Type
Thank you very much for selecting TRANSTEK Blood Pressure Monitor
TMB-1490.
Please do read the user manual carefully and thoroughtly so as to ensure
the safe usage of this product, and keep the manual well for further
reference in case you have problems.
1
Table of Contents
CATALOGUE
INTRODUCTION..................................................................................................................2
General Description
Safety Information
LCD Display Signal
Monitor Components
BEFORE YOU START..........................................................................................................6
The Choice of Power Supply
Installing and Replacing the Batteries
Measurement Principle
Setting Date, Time and Measurement Unit
MEASUREMENT................................................................................................................10
Tie the Cuff
Start the Measurement
DATA MANAGEMENT........................................................................................................12
Recall the Records
Delete the Records
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?
Why does my blood pressure fluctuate throughout the day?
Why the blood pressure I get from the hospital is different from home?
If the result is the same if measuring on the right arm?
TROUBLESHOOTING.......................................................................................................18
SPECIFICATIONS..............................................................................................................19
AUTHORIZED COMPONENT ...........................................................................................20
CONTACT INFORMATION.................................................................................................20
COMPLIED EUROPEAN STANDARDS LIST.....................................................................21
EMC GUIDANCE................................................................................................................22
2 3
Safety Information
The below signs 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 “COMPLIES WITH
MDD 93/42/EEC REQUIREMENTS”
Symbol for “MANUFACTURER”
Symbol for “SERIAL NUMBER”
Symbol for “TYPE BF APPLIED
PARTS”
Symbol for “DIRECT CURRENT”
Symbol for “ENVIRONMENT
PROTECTION - Wast electrical
products should not be disposed of
with household waste. Please recycle
where facilities exist. Check with your
local authority or retailer for recycling
advice”
Symbol for “Authorised Representative
in the European Community
EC REP
Symbol for “MANUFACTURE
DATE”
Thank you for selecting TRANSTEK arm type blood pressure Monitor
(TMB-1490). The monitor features blood pressure measurement, pulse
rate measurement and the result storage. The design provides you with
two years of reliable service.
Reading taken by the TMB-1490 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 instruction for using the product.
Read the manual thoroughly before using the product.
Features:
Maximum 250 records
General Description
For indoor use only
F1
T1A/250V Φ3.6*10CCC
Symbol for “Class II Equipment”
3rd technonoly: Measuring during inflation
(The updated technology in the world)
60×92 mm Bright LCD display
INTRODUCTION INTRODUCTION
This device is intended for adult use only.
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 based solely 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.
When the device was used to measure patients who have common arrhythmias such as atrial or ventricular
premature beats or artrial fibrillation, the best result may occure deviation. Please consult your physician about
the result.
If the cuff pressure exceeds 40 kPa (300 mmHg), the unit will automatically deflate. Should the cuff not deflate
when pressures exceeds 40 kPa (300 mmHg), detach the cuff from the armand press the START/STOP button to
stop inflation.
The equipment is not AP/APG equipment and not suitable for use in the presence of a flammable anesthetic
mixture with air of with oxygen or nitrous oxide.
The operator shall not touch output of batteries /adapter and the patient simultaneously.
To avoid measurement errors, please avoid the condition of strong electromagnetic field radiated interference
signal or electrical fast transient/burst signal.
The user must check that the equipment functions safely and see that it is in proper working condition before
being used.
This device is contraindicated for any female who may be suspected of, or is pregnant. Besides provided
inaccurate readings, the affects of this device on the fetus are unknown.
Manufacturer will make available on request circuit diagrams, component parts list etc.
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.
Please use the device under the environment which was provided in the user manual. Otherwise, the
performance and lifetime of the device will been impacted and reduced.
During using, the patient will 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.
Please use ACCESSORIES and detachable partes specified/ authorised by MANUFACTURE. Otherwise, it may
cause damage to the unit or danger to the user/patients.
The device doesn’t need to be calibrated in two years of reliable service.
Please dispose of ACCESSORIES, detachable parts, and the ME EQUIPMENT according to the local guidelines.
If you have any problems with this device, such as setting up, maintaining or using, please contact with SERVICE
PERSONNEL of Transtek. Don’t open or repair the device by yourself.
Please report to Transtek if any unexpected operation or events occur.
Please use the soft cloth to clean the whole unit. Don’t use any abrasive or volatile cleaners.
The adaptor is specified as a part of ME equipment.
If 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.
The adapter insulates the device from the main supply. Do not position the plug in a position where it is difficult to
disconnect from the supply mains.
The device is not intended for PATIENT transport outside a healthcare facility.
This device cannot be used with HF surgical equipment at the same time.
The patient is an intended operator. The patient can measure,query records and change battery under normal
circumstances and maintain the device and its accessories according to the user manual.
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: 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 upper arm on the side of
a mastectomy.
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.
Using it in case to result in prolonged impairment of the circulation of the blood of the PATIENT.
Don't link the connection tube, otherwise, the cuff pressure may continuously increase which
can prevent blood flow and result in harmful injury to the PATIENT.
CAUTION
4 5
LCD display signal
SYMBOL DESCRIPTION
Systolic blood pressure High pressure result
Diastolic blood pressure Low pressure result
EXPLANATION
Pulse per minute Beats per minute, BPM
Deflating CUFF air is exhausting of deflating
Memory
The displayed measurement values
is from the memory.
mmHg
kPa
Measurement Unit of the blood pressure
Measurement Unit of the blood pressure
Low battery
Batteries are low and need to be replaced
Irregular heartbeat
Arrhythmia
Grade The grade of the blood pressure
kPa
mmHg
Current Time
Year/Month/Day, Hour/Minute
Pul/min
MEMOR Y
TIM E/DATE
Pul/min
User A
Start measurement for User A
User B
Start measurement for User B
Heartbeat detection during the
measurement
Heartbeat
INTRODUCTION
Monitor Components
List
1.Blood Pressure Monitor
(TMB-1490)
4.User manual
2.Cuff (Type BF applied part) (22~32cm or 22~42cm)
Component list of
pressure measuring system
1 Cuff
2 Air pipe
3 PCBA
4 Pump
5 Valve
3. 4×AAA batteries
BATTERY COMPARTMENT
CUFF
AIR HOSE
AIR CONNECTOR PLUG
LCD DISPLAY
MEM BUTTON
START•STOP BUTTON
SET BUTTON
INTRODUCTION
S
M
STA RT
STO P
USER SWITCH
5. AC Adaptor
(UE08WCP-060100SPA)
The average value
The average value of the latest three
records
7
6
In order to get the best effect and protect your monitor,please use the
the right batteries and special power adapter. which complies with CE
safety standard.
• .Open the battery cover.
• .Install the batteries by matching
the correct polarity, as shown.
• .Replace the cover.
Installing and Replacing the Batteries
CAUTION
Remove batteries if the device is not likely to be used for some time.
The old batteries are harmful to the environment, so please disposal with other daily trash.
Remove the old batteries from the device and follow your local recycling guidelines.
CAUTION
Replace the batteries whenever the below happen
The shows
The display dims
The display does not light up
Do not dispose of batteries in fire. Batteries may explode or leak.
AC adaptor
The Choice of Power Supply
1.Battery powered mode:
6VDC 4×AAA batteries
2.AC adaptor powered mode:
(Please only use the recommended AC
adaptor model).
Please unplug the adaptor to depart from
the using utility power.
BEFORE YOU START
Measurement Principle
Setting Date, Time and Measurement Unit
It is important to set the clock before using your blood pressure
monitor, so that a time stamp can be assigned to each record that
is stored in the memory. (The setting range of the year :2014—2054
time format:12 H/24H)
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.
The device also compares the longest and the shortest time intervals of detected
pulse waves to mean time interval then calculates standard deviation. The device will
displays a warning signal with the reading to indicate the detection of irregular heartbeat
when the difference of the time intervals is over 25%.
1.When the monitor is off,
hold pressing “SET”
for 3 seconds to enter
the mode for year
setting.
Or when the monitor is off,
press “SET” button shortly,
it will display the time. Then
hold pressing “SET” button
to enter the mode for year
setting.
2.Press the “MEM” to
change the [YEAR].
Pul/min
MEMORY
TIME/ DATE
S
M
START
STOP
Pul/min
MEMORY
TIME/ DATE
S
M
START
STOP
BEFORE YOU START
6V 1A
9
8
BEFORE YOU START
BEFORE YOU START
3.When you get the right
year, press “SET” to set
down and turn to next
step.
4.Repeat step 2 and 3 to set
the [MONTH] and [DAY].
5.Repeat step 2 and 3 to set the [TIME FORMAT]
between 12h and 24h.
Pul/min
MEMORY
TIME/ DATE
S
M
START
STOP
Pul/min
MEMORY
TIME/ DATE
S
M
START
STOP
Pul/min
MEMORY
TIME/ DATE
S
M
START
STOP
Pul/min
MEMORY
TIME/ DATE
S
M
START
STOP
6.Repeat step 2 and 3 to set the [HOUR]
and [MINUTE].
8.After the unit is set,the LCD will display
“dOnE”first,then display all the settings you
have done and then it will turn off.
7.Repeat step 2 and 3 to set the [UNIT].
Pul/min
MEMORY
TIME/ DATE
S
M
START
STOP
Pul/min
MEMORY
TIME/ DATE
S
M
START
STOP
Pul/min
MEMORY
TIME/ DATE
S
M
START
STOP
Pul/min
MEMORY
TIME/ DATE
S
M
START
STOP
Pul/min
MEMORY
TIME/ DATE
S
M
START
STOP
11
10
MEASUREMENT
MEASUREMENT
Resting For 5 minutes before
measuring.
Wait at least 3 minutes between
measurements. This allows your
blood circulation to recover.
For a meaningful comparison,
try to measure under similar
conditions. For example, take daily
measurements at approximately
the same time, position of upper
arm, or as directed by a physician.
Tie the cuff
1.Tie the cuff on your upper arm,
the position the tube off-center
toward the inner side of arm in
line with the little finger.
2.The cuff should be sung but not
too tight. You should be able to
insert one finger between the
cuff and your arm.
3.Sit comfortably with your tested
arm resting on a flat surface.
2~3cm
.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 arm supported.
4
START
STOP
1.Before you start the measurement, switch the User button to select the user
between User A and User B. Switch to right to select User A, switch to left to
select User B. When the monitor is off,press the “START•STOP button to turn
on the monitor, and it will finish the whole measurement. And save the
measurement data for the desired user. (Take User A for example.)
Adjust the zero. LCD display
Inflating and measuring. Display and save the
measurement result.
Start the Measurement
2.Press the “START•STOP” to power
off, otherwise it will turn off
within 1 minute.
Pul/min
MEMORY
TIME/ DATE
S
M
START
STOP
Pul/min
MEMORY
TIME/ DATE
S
M
START
STOP
Pul/min
MEMORY
TIME/ DATE
S
M
START
STOP
Pul/min
MEMORY
TIME/ DATE
S
M
START
STOP
Tips: Maximum 250 records are both for User A and User B.
13
12
Recall the Records
2. Press the “MEM” or “SET” to get the record you
want. Press and hold the “MEM” button to look
over ten groups of the historical records quickly.
The most recent record (1) is shown first. Each new measurement is
assigned to the first (1) record. All other records are pushed back one
digit (e.g., 2 becomes 3, and so on), and the last record (250) is
dropped from the list.
The current No. is No 2. The corresponding
time is P.M. 10:08.
The corresponding
date is January 2nd.
CAUTION
The date and time
of the record
will be shown
alternately.
Pul/min
MEMORY
TIME/ DATE
S
M
START
STOP
Pul/min
MEMORY
TIME/ DATE
S
M
START
STOP
Pul/min
MEMORY
TIME/ DATE
S
M
START
STOP
DATA MANAGEMENT DATA MANAGEMENT
If you did not get the correct measurement, you can delete all
results for the selected user by following below steps.
Delete the Records
1.Hold pressing “SET”
for 3 seconds when the
monitor is in the memory
recall mode ,the
flash display “dEL ALL” will
show.
2.Press “SET” to
confirm deleting and
the monitor will turn
off.
3.If you don’t want to delete the
records, press “START/STOP”
to escape.
4. If there is no record.
Press “MEM” button,
the right display will
show.
Pul/min
MEMORY
TIME/ DATE
S
M
START
STOP
Pul/min
MEMORY
TIME/ DATE
S
M
START
STOP
Pul/min
MEMORY
TIME/ DATE
S
M
START
STOP
START
STOP
3. If you want to look over another user’s data, switch the User button to select
the desired user. Then you can look over its historical records.
1. When the monitor is off,
please press the “MEM”,it will display the
latest record first when the records are less than
three groups. When there are more than three
groups ,it will display the average value of the
latest three records first.
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14
INFORMATION FOR USER
INFORMATION FOR USER
Tips for Measurement
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
It can cause inaccuracy if the measurement is taken in the following
circumstances.
Maintenance
In order to get the best performance, please follow the below
instructions.
Put in a dry place and
avoid the sunshine
Avoid the intense shaking
and collision
Using the wet clothing to
remove the dirt
Avoid touching water,
clean it with a dry cloth in case.
Avoid the dusty and unstable-
temperature environment
Do not attempt to clean the reusable
cuff with water and never immerse
the cuff in water.
17
16
ABOUT BLOOD PRESSURE ABOUT BLOOD PRESSURE
Only a physician can tell your 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.
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.
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:
Irregular Heartbeat Detector
This Blood Pressure Monitor is equipped with an intelligent function of Irregular
Heartbeat (IHB) Detector. During each measurement, this equipment records the
heartbeat intervals and works out the standard deviation. If the calculated value is
larger than or equal to 15, this equipment will light up the IHB symbol on the
screen when displaying the measuring result.
CAUTION
The appearance of the IHB icon indicates that a pulse irregularity consistent with an irregular
heart-beat was detected during measurement. Usually this is NOT a cause for concern.
However, if the symbol appears often, we recommend you seek medical advice. Please note
that the device does not replace a cardiac examination, but serves to detect pulse irregularities
at an early stage.
CAUTION
1. Individual blood pressure varies
every in one day, it also affected by the
way you tie your cuff and the your
measurement position, so please take
the measurement at the same condition.
3.Waiting at least 3 minutes for
another measurement.
Why does my blood pressure
fluctuate throughout the
day?
If the result is the same
if measuring on the
right arm?
It is ok for both arms, but there
will be some different results for
different person, so suggest you
measure the same arm every time.
Why the blood pressure
I get from the hospital
is different from home?
The blood pressure is different even
during 24 hour because of the
weather,emotion, exercise etc,
specially the “white coat” in hospital
which makes the results are higher
than the ones at home.
The attention need to pay
when you measure you 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 pressured.
You had better take deep breath 2-3
times before beginning.
Advice:adjust yourself for 4-5
minutes until you calm down.
2.The variations in the pressure can
be greater or smaller, depending on
the actual medicine taken.
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
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18
TROUBLESHOOTING
SPECIFICATIONS
This section includes a list of error messages and frequently
asked questions for problems you may encounter with your blood
pressure monitor. If the products not operating as you think it
should, check here before arranging for servicing.
PROBLEM SYMPTOM CHECK THIS REMEDY
No power
Low
batteries
Error
massage
Display will not
light up.
Batteries are exhausted.
Replace with new batteries
Insert the batteries
correctly
Replace with new batteries
Batteries are inserted
incorrectly.
Display is dim or
show
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
E 3 shows
The pressure of the
cuff is excess.
Relax for a moment
and then measure again.
E10 or E11
shows
E20 shows
The measurement
process does not detect
the pulse signal.
Loosen the clothing on the
arm and then measure
again
EExx,shows on
the display.
A calibration error
occurred (XX can be
some numeric
characters,such as 01,
02 and so on .
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.
E21 shows
The treatment of the
measurement failed.
Relax for a moment and
then measure again.
AC adaptor is inserted
incorrectly.
Insert the AC adaptor
tightly
Readjust the cuff ,not too
loose or too tight and then
measure again.
The monitor detected
motion,talking or the
pluse is too poor
while measuring.
Relax for a
moment and then
measure again.
About 22~32cm or 22cm~42cm
Type BF applied part
WARNING: No modification of this equipment is allowed.
Temperature:-20℃-60℃
Relative Humidity 10%-93%
Atmospheric Pressure: 50-106 kPa
Temperature:5℃ to 40℃ Relative humidity ≤85%
Atmospheric pressure: 86kPa to 106kPa
Power supply
Battery powered mode:
6VDC 4×AAA batteries
AC adaptor powered mode:
(Please only use the recommended AC
adaptor model).
Display mode
Measurement mode
Oscillographic testing mode
Measurement range
Measurement perimeter
of the upper arm
Net Weight
Approx.250g(Excluding the dry cells)
External dimensions
Attachment
Mode of operation
Continuous operation
Degree of protection
Protection against
ingress of water
IP21
Accuracy
Normal working condition
Storage & transportation
condition
Software Version V01
Pressure:
5℃-40℃within±0.4kpa(3mmHg)
pulse value:±5%
Rated cuff pressure:
0kpa - 40kpa (0mmHg~300mmHg)
Measurement pressure: 5.3kPa-30.7kPa
(40mmHg-230mmHg)
pulse value: (40-199) beat/minute
Digital LCD V.A.60×92mm
Approx.140×130×49.7mm
4×AAA batteries,user manual
6V 1A
21
20
AUTHORIZED COMPONENT
COMPLIED EUROPEAN
STANDARDS LIST
Contact Information
For more information about our products, please visit www.transtek.cn.you can get customer
service, usual problems and customer download, transtek will serve you anytime.
Authorized European Representative:
Manufactured by:
GUANGDONG TRANSTEK MEDICAL ELECTRONICS CO., LTD
Company:
GUANGDONG TRANSTEK MEDICAL ELECTRONICS CO., LTD
Address:
Zone A, 5/F., Investment Building , No. 12, Huizhan East Rd., Torch
Development District, Zhongshan, Guangdong, 528437, China
Company:
MDSS - Medical Device Safety Service GmbH
Address:
Schiffgraben 41, 30175 Hannover, Germany
Authorized Component
1.please use the TRANSTEK
authorized adapter.
Complied European Standards List
Adapter
Type：UE08WCP-060100SPA
Input：100~240V，50~60Hz,400mA
Output：6V 1A
(Conforms to UL certificate)
Risk management
Labeling
User manual
General
Requirements for
Safety
Electromagnetic
compatibility
Performance
requirements
Clinical investigation
Usability
Software life-cycle
processes
ISO/EN 14971:2012 Medical devices — Application of risk
management to medical devices
EN 15223-1:2012 Medical devices. Symbols to be used
with medical device labels, labelling and information to be
supplied. General requirements
EN 1041: 2008 Medical equipment manufacturers to
provide information
EN 60601-1:2006 Medical electrical equipment - Part 1:
General requirements for basic safety and essential
performance
EN 60601-1-11: 2010 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 Medical electrical equipment - Part
1-2: General requirements for basic safety and essential
performance - Collateral standard:Electromagnetic
compatibility - Requirements and tests
EN 1060-1:1995+A2:2009 Non-invasive blood pressure
Part 1: General requirements
EN 1060-3:1997+A2:2009 Non-invasive blood pressure
Part 3: Supplementary requirements for electromechanical
blood pressure measuring system
EN 1060-4: 2004 Automatic Blood Pressure Monitor
overall system Interventional accuracy of the testing process
EN 60601-1-6: 2010 Medical electrical equipment -- Part
1-6: General requirements for basic safety and essential
performance - Collateral Standard: Usability
EN 62366: 2008 Medical devices - Application of usability
engineering to medical devices
EN 62304:2006+AC: 2008 Medical device software -
Software life cycle processes
EMC Guidance
1. MEDICAL ELECTRICAL EQUIPMENT needs special precautions
regarding EMC and needs to be installed and put into service
according to the EMC information provided in the ACCOMPANYING
DOCUMENTS
2. 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=3, 3m away from the equipment.
(Note: As indicated in Table 6 of IEC 60601-1-2:2007 for ME
EQUIPMENT, a typical cell phone with a maximum output power of 2
W yields d=3, 3m at an IMMUNITY LEVEL of 3V/m)
EMC GUIDANCE
22
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