User Manual
version:1.0
Guangdong Transtek Medical Electronics Co., Ltd.
Zone A, No.105 ,Dongli Road, Torch Development District,
Zhongshan,528437,Guangdong,China
Blood Pressure Monitor
TMB-1591
Arm Type
Thank you very much for selecting TRANSTEK Blood Pressure
Monitor TMB-1591.
To use the monitor correctly and safely, please read the manual
thoroughly.
Please keep this manual well in order to reference in future.
CATALOGUE
CATALOGUE
Table of Contents
INTRODUCTION........................................................................................2
General Description
Safety Information
Indications for Use
LCD Display Signal
Monitor Components
BEFORE YOU START................................................................................7
The Choice of Power Supply
Installing and Replacing the Batteries
MEASUREMENT.......................................................................................8
Pairing
Tie the Cuff
Start the Measurement
INFORMATION FOR USER......................................................................13
Tips for measurement
Maintenances
ABOUT BLOOD PRESSURE....................................................................15
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 arm?
TROUBLESHOOTING..............................................................................17
SPECIFICATIONS.....................................................................................18
AUTHORIZED COMPONENT ..................................................................19
CONTACT INFORMATION........................................................................19
COMPLIED STANDARDS LIST.................................................................20
FCC STATEMENT......................................................................................21
IC STATEMENT..........................................................................................22
EMC GUIDANCE.......................................................................................23
1
INTRODUCTION
INTRODUCTION
General Description
Thank you for selecting TRANSTEK arm type blood pressure
monitor (TMB-1591). 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 TMB-1591 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:
68mm*90mm Digital LCD display with White backlight
Maximum 99 records
Measuring during inflation technology
Indications for Use
The Transtek Blood Pressure Monitor 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.
Measurement Principle
This product uses the Oscillometric Measuring method to
detect blood pressure. Before every measurement, the unit
establishes a “zero pressure” equivalent to the air pressure. Then
it starts inflating the arm cuff, meanwhile, the unit detects pressure
oscillations generated by beat-to-beat pulsatile, which is used to
determine the systolic and diastolic pressure, and also pulse rate.
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 display a warning
signal with the reading to indicate the detection of irregular
heartbeat when the difference of the time intervals is over 25%.
Safety Information
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”
The Bluetooth Combination
Mark
Symbol for “MANUFACTURER”
For indoor use only
F1
T1A/250V Φ3.6*10CCC
WARNING:These warning notes
must be observed to preventany
injury to the user.
The ingress protection: the device could protected against solid foreign
objects of 12.5mm and greater, and against vertically falling water drops
IP22
when ENCLOSURE tilted up to 15°
Symbol for “KEEP DRY”
WARNING
1. The device is not suitable for measuring the blood pressure of children. Ask your
doctor before using it on older children.
2. The device is not suitable for use on pregnant women, patients with implanted,
electrocical devices, patients with pre-elcampsia, 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
3.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.
4.Please keep the unit out of reach of infants, children or pets, since inhalation or
swallowing of small parts is dangerous or even fata.
Do not dispose of batteries in fire. Batteries may explode or leak.
5.
Symbol for “TYPE BF APPLIED
PARTS”
Symbol for “ENVIRONMENT
PROTECTION – Electrical waste
products should not be disposed
of with household waste. Please
followlocal guidelines.”
Symbol for “DIRECT CURRENT”
Symbol for “Class II Equipment”
Caution: These notes must be
observed to prevent any damage
to the device.
Symbol for “SERIAL NUMBER”
SN
32
INTRODUCTIONINTRODUCTION
CAUTION
This device is intended only for adult use in homes.
This device is intended for non-invasive measuring and monitoring of arterial blood pressure.
It is not intended for use on extremities other than arm or for functions other than obtaining a
blood pressure measurement.
If you experience discomfort during a measurement, such as pain in the arm or other
complaints, press the START/STOP button to release the air immediately from the cuff.
Loosen the cuff and remove it from your arm.
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.
Too frequent and consecutive measurements could cause disturbances in blood circulation
and injuries.
Do not wrap the cuff on the same arm which other monitoring ME EQUIPMENT is applied
simultaneously, because this could cause temporary loss of function of those
simultaneously-used monitoring ME EQUIPMENT.
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.
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.
This unit is not suitable for continuous monitoring during medical emergencies or operations.
This device cannot be used with HF surgical equipment at the same time.
This device is not intended for patient transports outside a healthcare facility.
To avoid measurement errors, please avoid the condition of strong electromagnetic field
radiated interference signal or electrical fast transient/burst signal.
The operator shall not touch output of batteries/adapter and the patient simultaneously.
Manufacturer will make available on request circuit diagrams, component parts list etc.
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.Never apply the cuff over hurt skin.
Do not use the unit in case of existing polyester resp. synthetic allergies.
Be careful to strangulation due to cables and hoses, particularly due to excessive length.
Do not connect the air hose to other medical equipment, as this could cause air to be pumped
into intravascular systems or high pressure, what could lead to dangerous injuries.
Before use, make sure the device functions safely and is in proper working condition.
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.
Please use ACCESSORIES and detachable partes specified/ authorised by
MANUFACTURE. Otherwise, it may cause damage to the unit or danger to the user/patients.
Please dispose of ACCESSORIES, detachable parts, and the ME EQUIPMENT according to
the local guidelines.
Please do not attempt to repair the unit yourself in the event of malfunctions. Only have
repairs carried out by authorized service centers.
Please report to Manufacturer if any unexpected operation or events occur.
The device doesn’t need to be calibrated in two years of reliable service.
Please use the soft cloth to clean the whole unit. Don’t use any abrasive or volatile cleaners.
The patient is an intended operator.The patient can measure and change battery under
normal circumstances and maintain the device and its accessories according to the user
manual.
Don't press or restrict the connection tubing during measurement. The device is not intended
for public use.
LCD Display Signal
SYMBOL DESCRIPTION
Systolic blood pressure High pressure result
Diastolic blood pressure Low pressure result
Pulse
mmHg Measurement Unit of the blood pressure
Irregular heartbeat
Battery Indicator Indicate the current battery
Grade
Shocking reminder
Data transmission error
Heartbeat
SYS
mmHg
DIA
mmHg
PULSE
/MIN
EXPLANATION
Pulse/minute
Irregular heartbeat detection
The grade of the blood pressure
Shocking will result in inaccurate
Data transmission error
Heartbeat dectetion during measurement
54
INTRODUCTION BEFORE YOU START
Monitor Components
CUFF
AIR HOSE
AIR CONNECTOR PLUG
ON/STANDBY BUTTON
Component list of
pressure measuring system
1 Cuff
2 Air pipe
3 PCBA
4 Pump
5 Valve
List
1. Blood Pressure Monitor
(TMB-1591)
3. 4*AA alkaline Batteries
5. AC adaptor (UE08WCP-060100SPA)
2. Cuff (22cm~42cm)
(Type BF applied part)
4. User manual
LCD DISPLAY
DC POWER SOCKET
BATTERY COMPARTMENT
The Choice of Power Supply
1.Battery powered mode:
6VDC 4*AA alkaline batteries
(Notes: A groups of new batteries can be
used about 750 times.
2.AC adaptor powered mode:
6V 1A
(Can be supplied by AC adaptor model
UE08WCP-060100SPA !)
Right picture is the hole in for
power adaptor.
CAUTION
In order to get the best effect and protect your monitor,please use the right
battery and special power adaptor. The power adapter is a part of the device.
After using, please pull out the adaptor plug insulates from the main supply.
Do not position the device in a position where it is difficult to disconnect from
the supply mains.
Installing and Replacing the Batteries
１.Slide off the battery cover.
２.Install the batteries by
matching the correct polarity,
as shown.
３.Replace the cover.
Replace the batteries whenever the below happen
The shows
The display dims
The display does not light up
CAUTION
Remove batteries if the device is not likely to be used for some time.
The old batteries are harmful to the environment, do not dispose with other
daily trash.
Remove the old batteries from the device and follow your local recycling
guidelines.
76
MEASUREMENT MEASUREMENT
Pairing
Turn on Bluetooth and APP. Make sure both are ON when pairing is
proceeding.
When the blood pressure monitor is off, press On/Standby button for
2 full seconds to enter bluetooth pairing mode. The symbol
flashes, indicating the pairing is proceeding.
Then please select the user ID you want to connect with your
smartphone on the app to continute the pair-up.
If succeed, symbol will be shown. Then blood pressure monitor
will turn off.
If fail, symbol will flash all the time until the blood pressure
turns off.
Bluetooth Module No.: AW2540MV1
RF Frequency Range: 2402 MHz to 2480 MHz
Output Power Range: -1 dBm
Supply Voltage: 2V-3.6 V
Transmitting Distance: 10 meters
Tie the Cuff
1.Tie the cuff on your upper arm,
then position the tube off-center
toward the inner side of arm in
line with the little finger.
2.The cuff should be snug but not
too tight. You should be able to
insert one finger between the
cuff and your arm.
3.Sit comfortably with your arm
resting on a flat surface.
4.Correct position:
- Bare your arm or wear tights only
when starting measurement.
- Sit comfortably with legs
uncrossed, feet flat on the floor,
back and arm supported.
The center of the cuff should be at
the same level as the right atrium
of the heart.
Rest 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, on the same upper
arm, or as directed by a physician.
2~3cm
98
MEASUREMENT MEASUREMENT
Start Measurement
When the blood pressure monitor is off, press On/Standby button to
turn it on, it will finish the whole measurement.
LCD display Adjust to zero.
Inflating and Measuring
Display and save the result.
The blood pressure monitor will proceed to data transmission after
measurement. The bluetooth symbol flashes on the LCD indicates
data is transmitting.
After successful transfer, the device powers off the Bluetooth
radio and the icon (and rectangle) are removed.
If the user presses and releases the On/Standby button, another
reading is initiated.
If the user presses and holds the On/Standby button for 2
seconds, the device powers down.
Or if there is no operation, after a 10 seconds of inactivity, the
device powers down.
Notes: During inflation, the heart icon in the upper left blinks in
accordance with the user’s pulse rate.
Additionally, during inflation the progress metre to the right of
the digits builds vertically up as the pressure increases
according to the table below.
Segments Pressure
1 >= 0
2 >= 40
3 >= 80
4 >= 120
Segments Pressure
5 >= 140
6 >= 160
7 >= 180
8 >= 200
1110
MEASUREMENT INFORMATION FOR USER
Tips for Measurement
During the measurement, if you press the On/Standby button to stop
the measurement, the numerics are cleared. It will display as below:
Measurements may be inaccurate if taken in the
following circumstances.
If you press and release the On/Standby button, another reading is
initiated.
If you press and hold the On/Standby button for 2 seconds, the
device powers down.
Or if there is no operation, after a 10 seconds of inactivity, the device
powers down.
CAUTION
The most recent record (1) is shown first. Each new
measurement is assigned to the first (1) record. All
other records are pushed back one digit (e.g., 2
becomes 3, and so on), and the oldest record (99) is
dropped from the list.
wait at least 1 hour after dinner
or drinking
Wait at least 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
1312
INFORMATION FOR USER ABOUT BLOOD PRESSURE
What are systolic pressure and diastolic
Maintenance
In order to get the best performance, please follow the
instructions below.
pressure?
When ventricles contract and pump blood
out of the heart, the blood pressure
reaches its maximum value in the cycle,
which is called systolic pressure. When
the ventricles relax, the blood pressure
reaches its minimum value in the cycle,
which is called diastolic pressure.
Systolic
blood discharging
artery
press
Diastolic
blood entering
vein
relax
What is the standard blood pressure
classification?
Put in a dry place and avoid the
sunshine
Avoid intense shaking
and collisions
Avoid touching water,
clean it with a dry cloth in case.
Avoid dusty and unstable
temperature environment
The chart on the right is
the standard blood
pressure classification
published by American
Heart Association
(AHA).
AHA Home Guideline for
Upper Limit of Normal BP
SYS 135 mm Hg
DIA 85 mm Hg
CAUTION
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.
This chart reflects blood pressure categories defined by American
Heart Association.
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#)
less than 120
120-139
140-159
160 or higher
Higher than 180
and
or
or
or
or
Diastolic
mmHg (lower#)
less than 80
80-89
90-99
100 or higher
Higher than 110
Irregular Heartbeat Detector
An irregular heartbeat is detected when a heartbeat rhythm varies while the
unit is measuring the systolic and diastolic blood pressure.During each
measurement, this equipment records the heartbeat intervals and works out
the standard deviation. If the calculated value is larger than or equal to
15,the irregular heartbeat symbol appears on the symbol when the
Using wet cloths to remove dirt
Avoid washing the cuff
measurement results are displayed.
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.
1514
ABOUT BLOOD PRESSURE TROUBLESHOOTING
This section includes a list of error messages and
Why does my blood
pressure fluctuate
throughout the day?
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 is
different even throughout the
day due to weather, emotion,
exercise etc, Also, there is the
“white coat” effect, which means
blood pressure usually
increases in clinical settings.
Is the result the same if
measuring on the right
arm?
It is ok for both arms, but
there will be some different
results for different people. We
suggest you measure the same
arm every time.
What you need to pay
attention to when you
measure your blood
pressure at home:
If the cuff is tied properly.
If the cuff is too tight or too
loose.
If the cuff is tied on the upper
arm.
If you feel anxious.
Taking 2-3 deep breaths
before beginning will be better for
measuring.
Advice: Relax yourself for 4-5
minutes until you calm down.
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.
The display
indicates the
“BAT LO”
message, pauses
for 3 seconds.
The battery icon
shows empty
(does not flash.)
E 01 shows
E 02 shows
E 03 shows The pressure of the
E 10 or
E 11 shows
E 20 shows The measurement
E 21 shows
EExx,shows on
the display.
Batteries are exhausted.
Batteries are inserted
incorrectly.
AC adaptor is inserted
incorrectly.
Batteries are low.
Unsuccessful pairing.
shows
The cuff is not secure.
The cuff is too tight or
the inflation is too fast.
cuff is excess.
The monitor detected
motion,talking or the
pluse is too poor
while measuring.
process does not detect
the pulse signal.
Measure incorrectly.
A calibration error
occurred.
Replace with new batteries
Insert the batteries
correctly
Insert the AC adaptor
tightly
Replace with new batteries
Check if both the APP and
Bluetooth are on, operate
and send the data again.
Readjust the cuff and
relax for a moment
and then measure again.
Refasten the cuff and then
measure again.
Refasten the cuff and then
measure again.
Movement can affect the
measurement.Relax for a
moment and then
measure again.
Loosen the clothing on
the arm and then
measure again.
Relax for a moment and
then measure again.
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.
1716
SPECIFICATIONS AUTHORIZED COMPONENT
Battery powered mode:
Power supply
Display mode
Measurement mode
Measurement range
Accuracy
Normal working condition
Storage & transportation
condition
Measurement perimeter
of the upper arm
Net Weight
External dimensions
Attachment
Mode of operation
Degree of protection
Protection against
ingress of water
Software Version
6VDC 4*AA alkaline batteries
AC adaptor powered mode:
6V 1A
(Can be supplied by AC adaptor model
UE08WCP-060100SPA !)
Digital LCD V.A.68mm*90mm
Oscillographic testing mode
Rated cuff pressure: 0mmHg-300mmHg
Measurement pressure:
SYS:60mmHg-230mmHg
DIA: 40mmHg-130mmHg
pulse value:(40-199)beat/minute
Pressure:
5℃-40℃ within±3mmHg
pulse value:±5%
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 106 kPa
About 22cm~42cm
Approx.300g(Excluding the dry cells)
Approx.92mm*140mm*46mm
4*AA alkaline batteries,user manual
Continuous operation
Type BF applied part
IP20
V01
Authorized Component
１.please use the TRANSTEK
authorized adapter.
Adapter
Type： UE08WCP-060100SPA
Input：100~240V，50~60Hz,400mA
Output：6V 1A
( Conforms to UL certificate )
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.
Manufactured by:
Company:
Address:
Guangdong Transtek Medical Electronics Co., Ltd.
Guangdong Transtek Medical Electronics Co., Ltd.
Zone A, No.105 ,Dongli Road, Torch Development District,
Zhongshan,528437,Guangdong,China
WARNING: No modification of this equipment is allowed.
1918
COMPLIED STANDARDS LIST FCC STATEMENT
Complied Standards List
Risk management
Labeling
User manual
General Requirements
for Safety
Electromagnetic
compatibility
Performance
requirements and
Clinical investigation
Software life-cycle
processes
Usability
ISO/EN 14971:2012 Medical devices — Application of
risk management to medical devices
ISO/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
IEC 60601-1: 2005+A1：2012 Medical electrical
equipment - Part 1: General requirements for basic safety
and essential performance
IEC 60601-1-11 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
IEC60601-1-11:2010
IEC/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
IEC 80601-2-30:2009+A1:2013 Medical electrical
equipment- Part 2-30: Particular requirements for the
basic safety and essential performance of automated
non-invasive sphygmomanometers
ISO81060-2 Non-invasive sphygmomanometers —
Part 2: Clinical validation of automated
measurement type
IEC/EN 62304:2006+AC: 2008 Medical device
software - Software life cycle processes
IEC 62366 Medical devices - Application of usability
engineering to medical devices (IEC 62366:2007)
IEC 62366:2007+A1:2014
IEC 60601-1-6:2010+A1:2013 Medical electrical
equipment - Part 1 -6 : General requirements for basic
safety and essential performance - collateral standard :
Usability
FCC Statement
FCC ID: OU9TMB1591-B
This device complies with Part 15 of the FCC Rules. Operation is subject
to the following two conditions: (1) this device may not cause harmful
interference, and (2) this device must accept any interference received,
including interference that may cause undesired operation.
Caution: The user is cautioned that changes or modifications not
expressly approved by the party responsible for compliance could void the
user's authority to operate the equipment.
NOTE: This equipment has been tested and found to comply with the
limits for a Class B digital device, pursuant to Part 15 of the FCC Rules.
These limits are designed to provide reasonable protection against
harmful interference in a residential installation. This equipment generates,
uses and can radiate radio frequency energy and, if not installed and used
in accordance with the instructions, may cause harmful interference to
radio communications. However, there is no guarantee that interference
will not occur in a particular installation.
If this equipment does cause harmful interference to radio or television
reception, which can be determined by turning the equipment off and
on,the user is encouraged to try to correct the interference by one or more
of the following measures:
-- Reorient or relocate the receiving antenna.
-- Increase the separation between the equipment and receiver.
-- Connect the equipment into an outlet on a circuit different from that to
which the receiver is connected.
-- Consult the dealer or an experienced radio/TV technician for help.
FCC Radiation Exposure Statement:
This equipment complies with FCC radiation exposure limits set forth for
an uncontrolled environment.
This transmitter must not be co-located or operating in conjunction with
any other antenna or transmitter.
2120
IC STATEMENT EMC GUIDANCE
IC Statement
IC ID：12725A-TMB1591B
This device complies with Industry Canada license-exempt RSS
standard(s). Operation is subject to the following two conditions: (1) this
device may not cause interference, and (2) this device must accept any
interference, including interference that may cause undesired operation of
the device.
Le présent appareil est conforme aux CNR d'Industrie Canada applicables
aux appareils radio exempts de licence. L'exploitation est autorisée aux
deux conditions suivantes : (1) l'appareil ne doit pas produire de
brouillage, et (2) l'utilisateur de l'appareil doit accepter tout brouillage
radioélectrique subi, même si le brouillage est susceptible d'en
compromettre le fonctionnement.
EMC Guidance
1) This equipment needs to be installed and put into service
in accordance with the information provided in the user
manual;
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)
2322
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