User Manual
version:1.0
Blood Pressure Monitor
START
STOP
TMB-995-BS
Arm Type
FCC ID:OU9TMB995-BS
Guangdong Transtek Medical Electronics Co., Ltd.
Zone B, No.105 ,Dongli Road, Torch Development District,
Zhongshan,528437,Guangdong,China
Thank you very much for selecting TRANSTEK Blood Pressure Monitor
TMB-995-BS.
To use the monitor correctly and safely, please read the manual thoroughly.
Please keep well this manual in order to reference in future.
CATALOGUE
CATALOGUE
Table of Contents
INTRODUCTION...................................................................................................................2
General Description
Indications for Use
Contraindications
Measurement Principle
Safety Information
LCD Display Signal
Monitor Components
List
BEFORE YOU START...........................................................................................................9
The Choice of Power Supply
Installing and Replacing the Batteries
Setting Date and Time
Select the User
MEASUREMENT.................................................................................................................13
Tie the Cuff
Start the Measurement
DATA MANAGEMENT..........................................................................................................15
Recall the Records
Delete the Records
INFORMATION FOR USER................................................................................................19
Tips for measurement
Maintenances
ABOUT BLOOD PRESSURE..............................................................................................21
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........................................................................................................23
SPECIFICATIONS...............................................................................................................24
AUTHORIZED COMPONENT ............................................................................................25
CONTACT INFORMATION..................................................................................................25
COMPLIED STANDARDS LIST...........................................................................................26
FCC STATEMENT................................................................................................................27
EMC GUIDANCE.................................................................................................................28
1
INTRODUCTION INTRODUCTION
General Description
Thank you for selecting TRANSTEK arm type blood pressure Monitor
(TMB-995-BS). 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-995-BS 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:
80*60mm Digital LCD display
Maximum 60 records per each user
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 22 cm to 32 cm ( about 8¾˝-12½˝ ) or 22cm to 42cm(about 8¾˝-16½˝).
It is intended for adult indoor use only.
Contraindications
1.The device is not suitable for use on may be pregnant women or pregnant women.
2.The device is not suitable for use on patients with implanted,electrical devices,
such as cardiac pacemakers, defibrillators.
Measurement Principle
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.
Safety Information
The signs below might be in the user manual, labeling or other components.
They are the requirement of standard and using.
Symbol for “THE OPERATION
GUIDE MUST BE READ”
Symbol for “MANUFACTURER”
Symbol for “SERIAL NUMBER”
SN
Symbol for “DIRECT CURRENT”
For indoor use only
F1
T1A/250V Φ3.6*10CCC
Caution: These notes must
be observed to prevent any
damage to the device.
The Green Dot is the license
symbol of a European
network of industry-funded
systems for recycling the
packaging materials of
consumer goods.
Symbol for “TYPE BF APPLIED
PARTS”
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”
Symbol for “Class II Equipment”
Symbol for “MANUFACTURE
DATE”
Symbol for “Recycle”
2 3
INTRODUCTION INTRODUCTION
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 was used to measure patients who have common arrhythmias such as
atrial or ventricular premature beats or atrial fibrillation, the best result may occur with
deviation. Please consult your physician about the result.
* Don't kink the connection tube during use, otherwise, the cuff pressure may continuously
increase which can prevent blood flow and result in harmful injury to the PATIENT.
* When using this device, please pay attention to the following situation which may interrupt
blood flow and influence blood circulation of the patient, thus 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.
* The device cannot be used with HF surgical equipment at the same time.
CAUTION
* The ACCOMPANYING DOCUMENT shall disclose that the SPHYGMOMANOMETER was
clinically investigated according to the requirements of ISO 81060-2:2013.
* To verify the calibration of the AUTOMATED SPHYGMOMANOMETER, please contact the
manufacturer.
* This device is contraindicated for any female who may be suspected of, or is pregnant.
Besides providing inaccurate readings, the effects of this device on the fetus are unknown.
* Too frequent and consecutive measurements could cause disturbances in blood circulation
and injuries.
* This unit is not suitable for continuous monitoring during medical emergencies or
operations.Otherwise, the patient’s arm and fingers will become anaesthetic, swollen and
even purple due to a lack of blood.
* When not in use, store the device with the adapter 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,transmit data and charge power 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, its adaptor, 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.
* 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 pressures 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!
4 5
INTRODUCTION
INTRODUCTION
CAUTION
* 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 insulates 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 Transtek. 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 Transtek 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, 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 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.
6
LCD Display Signal
SYMBOL DESCRIPTION
Systolic blood pressure High pressure result
Diastolic blood pressure Low pressure result
Pulse Pulse/minute
Deflating CUFF air is exhausting of deflating
Current Time
Memory If “MEM” shows, the displayed measurement
mmHg
Battery Indicator
Grade
Heartbeat Heartbeat dectetion during measurement
User 1
User 2
Data pending to transmit Measurement data stored in the equipment
Shocking reminder Shocking will result in inaccurate
Bluetooth icon
EXPLANATION
Time(year:month:day:hour:minute)
values is from the memory.
Measurement Unit of the blood pressure
Indicate the current battery
Irregular heartbeatIrregular heartbeat
The grade of the blood pressure
Start measurement and transmit the results for User 1
Start measurement and transmit the results for User 2
The bluetooth icon blinks when the bluetooth is
working
7
Monitor Components
CUFF
AIR HOSE
AIR CONNECTOR PLUG
START
STOP
SET/DOWN BUTTON
START/STOP BUTTON
MEM/UP BUTTON
LCD DISPLAY
BATTERY COMPARTMENT
BEFORE YOU STARTINTRODUCTION
The Choice of Power Supply
1.Battery powered mode:
6VDC 4*AA batteries
2.AC adaptor powered mode:
6V 1A
(Please use the AC adaptor which
authorized by the manufacturer!)
Right picture is the hole in for power
adaptor.
CAUTION
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.
Installing and Replacing the Batteries
Component list of
pressure measuring system:
1 Cuff
2 Air pipe
3 PCBA
4 Pump
5 Valve
List
1. Blood Pressure Monitor
(TMB-995-BS)
START
STOP
4. 4*AA batteries
8
2. Cuff (22~32cm or 22~42cm)
(Type BF applied part)
5. AC adaptor
(BLJ06L060100P-U)
3. User manual
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
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.
9
Setting Date and Time
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. (year :2018—2058 time:12 H)
1.When the unit is off,
hold pressing “SET ”
button for 3 seconds to
enter the mode for
year setting.
START
STOP
2.Press the “ MEM ”
button to change the
[YEAR].
4.Repeat steps 2 and 3 to set the [MONTH] and [DAY].
START
STOP
START
STOP
5.Repeat steps 2 and 3 to set the [HOUR] and [MINUTE].
BEFORE YOU STARTBEFORE YOU START
3.When you get the right
year, press “ SET ”
button to set down and
turn to next step.
10
START
STOP
START
STOP
START
STOP
6.After the [UNIT] is set, the LCD will
display “dOnE”, and then turn off.
START
STOP
START
STOP
11
MEASUREMENTBEFORE YOU START
Select the User
1.When the monitor is off , press the “SET” button
to enter user setting mode.
START
STOP
2.Then press “SET” button again, select the user ID user 1 and user 2 .
START
STOP
3. After selecting the suitable user ID, press “START/STOP” button to
confirm. Then the LCD will turn off.
Tie the Cuff
1.
Remove all jewelry, such as watches and
bracelets from your left arm.
Note: If your doctor has diagnosed you with
poor circulation in your left arm, use your right
arm.
2.
Roll or push up your sleeve to expose the
skin. Make sure your sleeve is not too tight.
3.
Hold your arm with your palm facing up and
tie the cuff on your upper arm, then position
the tube off-center toward the inner side of
arm in line with the little finger. Or position the
artery mark over the main artery (on the
inside of your arm). Note: Locate the main
artery by pressing with 2 fingers
approximately 2 cm above the bend of your
elbow on the inside of your left arm. Identify
where the pulse can be felt the strongest.
This is your main artery.
The cuff should be snug but not too tight.
4.
You should be able to insert one finger
between the cuff and your arm.
Sit comfortably with your tested arm resting on a
5.
flat surface.
the cuff is at the same level as your heart. Turn
your palm upwards. Sit upright in a chair, and take
5-6 deep breaths.
6.
Helpful tips for Patients, especially for Patients with
Hypertension:
Rest for 5 minutes before first measuring.
Wait at least 3 minutes between measurements.
This allows your blood circulation to recover.
Take the measurement in a silent room.
The patient must relax as much as possible and do
not move and talk during the measurement procedure.
The cuff should maintain at the same level as the
right atrium of the heart.
Please sit comfortably. Do not cross your legs and
keep your feet flat on the ground.
Keep your back against the backrest of the chair.
For a meaningful comparison, try to measure under
similar conditions. For example, take daily
measurements at approximately the same time, on the
same arm, or as directed by a physician.
Place your elbow on a table so that
2~3cm
12
13
MEASUREMENT
DATA MANAGEMENT
Start the Measurement
1.When the monitor is off,press the
START/STOP button to turn on the monitor,
and it will finish the whole measurement,save
and transmit the measurement data for the
desired user. (Take User 1 for example.)
LCD display
Inflating and measuring.
Display and save the results. The
data transmission will proceed.
START
STOP
Adjust the zero .
3.If the data is successfully
transmitted, the Bluetooth
symbol doesn’t blink any more,
and the will disappear.
If the data transmission fails,
the will proceed.
4.Press “START/STOP” button to
power off, otherwise it will turn
off within 1 minute.
START
STOP
Tips:
A. You can press “START/STOP” button at any time to stop measuring during
the process of measurement.
B. Maximum 60 records are both for USER 1 and USER 2.
C. If the measurement result is out of the measurement range (SYS: 60mmHg to
230mmHg; or DIA: 40mmHg to 130mmHg;or Pulse: 40-199 pulse/minute), the
LCD will display “out”.
2.This device will proceed
to data transmission
after measurement.
The Bluetooth symbol
blinks on the LCD
indicates data is
transmitting.
14
CAUTION
Interference may occur in the vicinity of equipment marked with the following symbol
. And TMB-995-BS 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?
1.
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.
2.
To avoid interference, other electronic devices (particularly those with wireless
transmission / Transmitter) should be kept at least 1 meter away from the monitor.
15
DATA MANAGEMENT
DATA MANAGEMENT
Recall the Records
1.When the monitor is off, please press “ MEM ” button to show the
average value of the latest three records.If the records are less than 3 groups,
it will display the latest record instead.Displays different colors at different levels
when the monitor is under the memory enquiry mode.
(Take user 1 for example.)
2. Press the “ MEM ” or “ SET ” button again to rotate the records.
The order of the record, date and time will be displayed alternatively.
The current is the No. 1.
Twenty records in total.
The corresponding date
is July 30th.
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 last record (60) is dropped
from the list.
The corresponding
time is A.M.9:00.
Delete the Records
If you did not get the correct measurement, you can delete all
results of the selected user by following steps below .
1.Hold pressing “ MEM ” button for 3 seconds when the monitor is under the
memory enquiry mode. The LCD will display the blinking “Use ID + dEL
ALL”.
2.Press “ MEM ” button to confirm deleting all the memories , the LCD will
display “Use ID + dEL dOnE” and the monitor will turn off.
Bluetooth Module No.:
RF Frequency Range: 2.402 - 2.480 GHz
Max Output Power:
Supply Voltage:
Transmitting Distance:
LS51802
-0.53dBm
1.8V - 3.6V
1-10 meters
16
17
DATA MANAGEMENT
INFORMATION FOR USER
3.Hold pressing “ SET ” button for 3 seconds when the monitor is under the
memory enquiry mode(excluding the LCD displays AVG). The LCD will
display the blinking “ Use ID + dEL ONE”.
4.Press “ MEM ” button to confirm deleting the last record, the LCD will
display “Use ID + dEL dOnE” and the monitor will turn off.
5.If you don’t want to delete the records, press the “START/STOP” button,
it will turn off and quit the deletion. Or when it is in the deleting memory
mode, it will turn off and quit the deletion if there is no operation in one
minute.
Tips for Measurement
Measurements may be inaccurate if taken in the following
circumstances.
wait at least 1 hour after dinner or drinking
Wait at least 20 minutes after taking a bath
Immediate measurement
after tea, coffee, smoking
When talking or moving your fingers
6. If there is no record, the LCD will display as the following picture:
18
In a very cold environment
When you want to discharge urine
19
ABOUT BLOOD PRESSUREINFORMATION FOR USER
Maintenance
In order to get the best performance, please follow the
instructions below.
START
STOP
START
STOP
Put in a dry place and avoid the sunshine
START
STOP
Avoid intense shaking
and collisions
START
STOP
Using wet cloths to remove dirt
Avoid touching water,
clean it with a dry cloth in case.
START
STOP
Avoid dusty and unstable
temperature environment
Avoid washing the cuff
What are systolic pressure and diastolic pressure?
When ventricles contract and pump blood out
of the heart, the blood pressure reaches its
maximum value in the cycle, which is called
systolic pressure. When the ventricles relax,
the blood pressure reaches its minimum value
in the cycle, which is called diastolic pressure.
Systolic
blood discharging
artery
press
Diastolic
blood entering
vein
relax
What is the standard blood pressure classification?
The chart on the right is the
standard blood pressure classification published by American
Heart Association (AHA).
CAUTION
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.
This chart reflects blood pressure categories defined by American Heart Association.
Blood Pressure Category
Normal
Elevated
High Blood Pressure
(Hypertension) Stage 1
High Blood Pressure
(Hypertension) Stage 2
Hypertensive Crisis
(Consult your doctor immediately)
Systolic
mmHg (upper#)
less than 120
120-129
130-139
140 or higher
Higher than 180
Diastolic
mmHg (lower#)
and
less than 80
and less than 80
or
80-89
or
90 or higher
and/or
Higher than 120
Irregular Heartbeat Detector
An irregular heartbeat is detected when a heartbeat rhythm varies while the unit is measuring
the systolic and diastolic blood pressure.During each measurement, the monitor records all the
pulse intervals and calculate the average ; if there are two or more pulse intervals ,the difference
between each interval and the average is more than the average value of ±25% , or there are four
or more pulse intervals ,the difference between each interval and the average is more than the
average value of ±15%,the irregular heartbeat symbol appears on the display when the
measurement results are appear.
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.
20
21
ABOUT BLOOD PRESSURE
TROUBLESHOOTING
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.
22
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.
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
Replace with new batteries
Insert the batteries
correctly
Insert the AC adaptor
tightly
Replace with new batteries
Check if the APP is on,
operate and send the data
again.
Readjust the cuff and
relax for a moment
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.
Relax for a moment.
Refasten the cuff and then
measure again. If the
problem persists, contact
your physician.
No power
Low
batteries
Error
message
Warning
message
Display
will not light up.
Display is dim or
shows
E 1 shows Communication error
E 3 shows
E10 or E11
shows
E20 shows
E21 shows
EExx,shows on
the display.
“out ” shows
Batteries are exhausted.
Batteries are inserted
incorrectly.
AC adaptor is inserted
incorrectly.
Batteries are low.
The cuff is not secure.
The monitor detected
motion,talking or the
pluse is too poor
while measuring.
The measurement
process does not detect
the pulse signal.
The treatment of the
measurement failed.
A calibration error
occurred.
Out of measurement
range
23
SPECIFICATIONS
AUTHORIZED COMPONENT
Power supply
Display mode
Measurement mode
Measurement range
Accuracy
Normal working condition
Storage & transportation
condition
Measurement perimeter
of the upper arm
Weight
External dimensions
Attachment
Mode of operation
Degree of protection
Protection against
ingress of water
Device Classification
Battery powered mode:
AC adaptor powered mode:
(Please only use the recommended AC
adaptor model).
Digital LCD V.A.60mm*80mm
Oscillographic testing mode
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
Pressure:
5℃-40℃within±3mmHg(0.4kPa)
Pulse value:±5%
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
About 22cm~32cm or 22cm~42cm
Approx.300g(Excluding the batteries)
Approx.102mm*143mm*73mm
4×AA
batteries,user manual,AC adapter
Continuous operation
Type BF applied part
IP21 It means the device could protected against
solid foreign objects of 12.5mm and greater, and
protect against vertically falling water drops.
Battery Powered Mode:
Internally Powered ME Equipment
AC Adaptor Powered Mode: Class II ME Equipment
6VDC 4×AA batteries
6V 1A
Authorized Component
1.please use the TRANSTEK
authorized adapter.
Adaptor
Type:
BLJ06L060100P-U
Input:
Output:
100-240V
6V 1000mA
50-60Hz,0.2Amax
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 B, No.105 ,Dongli Road, Torch Development District,
Zhongshan,528437,Guangdong,China
Software Version
24 25
WARNING: No modification of this equipment is allowed.
Unknow
COMPLIED STANDARDS LIST
Complied Standards List
Risk management
Labeling
User manual
General Requirements
for Safety
Electromagnetic
compatibility
Performance
requirements
Clinical investigation
Usability
Software life-cycle
processes
Bio-compatibility
EN ISO 14971:2012 / ISO 14971:2007 Medical devices -
Application of risk management to medical devices
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
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 60601-1-11:2015/ 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
EN 1060-3:1997+A2:2009 Non-invasive sphygmomanometers Part 3: Supplementary requirements for electro-mechanical blood
pressure measuring systems
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
EN 1060-4:2004 Non-invasive sphygmomanometers - Part 4: Test
procedures to determine the overall system accuracy of automated
non-invasive sphygmomanometers
ISO 81060-2:2013 Non-invasive sphygmomanometers - Part 2:
Clinical validation of automated measurement type
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 62366-1:2015/
Application of usability engineering to medical devices
EN 62304:2006/AC: 2008 / IEC 62304:2006 Medical device
software - Software life-cycle processes
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
IEC 62366-1:2015 Medical devices - Part 1:
FCC STATEMENT
FCC Statement
FCC ID:OU9TMB995-BS
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.
26 27
EMC GUIDANCE
EMC GUIDANCE
EMC Guidance
1)This product needs special precautions regarding EMC and needs to be
installed and put into service according to the EMC information provided,
and this unit can be affected by portable and mobile RF communications
equipment.
2)* Do not use a mobile phone or other devices that emit electromagnetic
fields, near the unit. This may result in incorrect operation of the unit.
3)Caution: This unit has been thoroughly tested and inspected to assure
proper performance and operation!
4)* Caution: This machine should not be used adjacent to or stacked with
other equipment and 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.
Table 1
Guidance and manufacturer’s declaration – electromagnetic emissions
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.
Emissions test Electromagnetic environment - guidance
RF emissions
CISPR 11
Compliance
Group 1
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.
Table 2
Guidance and manufacturer’s declaration – electromagnetic immunity
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.
Immunity test
Electrostatic
discharge (ESD)
IEC 61000-4-2
Electrical fast
transient/burst
IEC 61000-4-4
Surge
IEC61000-4-5
Voltage dips,
short interruptions
and voltage
variations on
power supply
input lines
IEC 61000-4-11
IEC 60601 test level
±8 kV contact
±15 kV air
power supply lines:
±2 kV
input/output lines:
±1 kV
line(s) to line(s): ±1 kV
line(s) to earth: ±2 kV
100 kHz repetition
frequency
0%UT; 0.5 cycle
At 0°, 45°, 90°, 135°,
180°,225°,270° and 315°
0%U
T
; 1 cycle
and
70%U
T
; 25/30 cycles
Single phase: at 0°
0% U
T
; 300 cycle
Compliance level
±8 kV contact
±15 kV air
power supply lines:
±2 kV
line(s) to line(s): ±1 kV
100 kHz repetition
frequency
0% U
T
; 0.5 cycle
At 0°, 45°, 90°, 135°,
180°,225°,270° and
315°
0% U
T
; 1 cycle
and
70% U
T
; 25/30 cycles
Single phase: at 0°
0% U
T
;300 cycle
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%.
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.
RF emissions
CISPR 11
Harmonic emissions
IEC 61000-3-2
Voltage fluctuations/
flicker emissions
IEC 61000-3-3
Class B
Class A
Complies
The device is suitable for use in all establishments,
other than domestic and those directly connected to
the public low-voltage power supply network that
supplies buildings used for domestic purposes.
Power frequency
(50Hz/60Hz)
magnetic field
IEC 61000-4-8
NOTE UT is the a.c. mains voltage prior to application of the test level.
30 A/m
50Hz/60Hz
30 A/m
50Hz/60Hz
Power frequency magnetic fields
should be at levels characteristic
of a typical location in a typical
commercial or hospital
environment.
28 29
EMC GUIDANCE
EMC GUIDANCE
Table 3
Guidance and manufacturer’s declaration – electromagnetic immunity
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.
Immunity test
Conducted RF
IEC 61000-4-6
Radiated RF
IEC 61000-4-3
IEC 60601
Test level
150 kHz to
80 MHz:
3 Vrms
6Vrms (in ISM
and amateur
radio bands)
80% Am at 1kHz
10V/m, 80% Am
at 1kHz
Compliance
level
150 kHz to
80 MHz:
3 Vrms
6Vrms (in ISM
and amateur
radio bands)
80% Am at 1kHz
10V/m, 80% Am
at 1kHz
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 appropriate for the frequency
of the transmitter.
Recommended separation distances:
d=0.35 ;
P
d=1.2
P
80 MHz to 800 MHz:
d=1.2
P
800 MHz to 2.7 GHz:
d=2.3
P
where, P is the maximum
output power rating of the
transmitter in watts (W)
according to the
transmitter manufacturer,
d is the recommended
separation distance in
meters (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.
Interference may occur in
the vicinity of equipment
marked with the following
symbol:
Table 4
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)
0.01
0.1
1
10
100
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 P is the maximum output power rating of the transmitter in watts (W) according to the
transmitter manufacturer.
NOTE 1 At 80 MHz and 800 MHz, 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.
Separation distance according to frequency of transmitter (m)
150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2.7 GHz
=d
3.5
P
0.12 0.12
0.37
1.2
3.8
12
=d 1.2
0.38
1.2
3.8
12
P
2.3=d
0.23
0.73
2.3
7.3
23
P
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 broadcast 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.
b
Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3V/m.
30 31
EMC GUIDANCE
Table 5
Guidance and manufacturer’s declaration - electromagnetic immunity
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.
Radiated RF
IEC61000-4-3
(Test
specifications
for
ENCLOSURE
PORT
IMMUNITY to
RF wireless
communicatio
ns equipment)
NOTE If necessary to achieve the IMMUNITY TEST LEVEL, the distance between the transmitting antenna
and the ME EQUIPMENT or ME SYSTEM may be reduced to 1 m. The 1 m test distance is permitted by
IEC 61000-4-3.
a) For some services, only the uplink frequencies are included.
b) The carrier shall be modulated using a 50% duty cycle square wave signal.
c) As an alternative to FM modulation, 50% pulse modulation at 18 Hz may be used because while it does
not represent actual modulation, it would be worst case.
The MANUFACTURER should consider reducing the minimum separation distance, based on RISK
MANAGEMENT, and using higher IMMUNITY TEST LEVELS that are appropriate for the reduced
minimum separation distance. Minimum separation distances for higher IMMUNITY TEST LEVELS shall be
calculated using the following equation:
E=
Where P is the maximum power in W, d is the minimum separation distance in m, and E is the IMMUNITY
TEST LEVEL in V/m.
Test
Frequency
(MHz)
385
450 380-390
710 704-787
745
780
810
870
930
1720
1845
1970
5240
5240
5785
Band a)
Service a) Modulation b) Modulation b)
(MHz)
380-390 TETRA
800-960
17001990
2570
51005800
400
GMRS 460，
FRS 460
LTE Band
13,
17
GSM
800/900,
TETRA 800,
iDEN 820,
CDMA 850,
LTE Band 5
GSM 1800;
CDMA 1900;
GSM 1900;
DECT;
LTE Band 1,
3,
4,25; UMTS
Bluetooth,
WLAN,
802.11
b/g/n, RFID
2450, LTE
Band 7
WLAN
802.11
a/n
Pulse
modulation b)
18Hz
FM c) ± 5kHz
deviation 1kHz
sine
Pulse
modulation b)
217Hz
Pulse
modulation b)
18Hz
Pulse
modulation b)
217Hz
Pulse
modulation b)
217 Hz
Pulse
modulation b)
217 Hz
(W)
1.8
2 0.3 28
0.2 0.3 9
2
2
2
0.2
Distance (m)
0.3 27
0.3 28
0.3 28
0.3 282450 2400-
0.3 9
IMMUNITY
TEST
LEVEL
(V/m)
32
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