Transtek Medical Electronics LS808-B-S Bluetooth Blood Pressure Monitor User Manual LS808 BS FDA
Guangdong Transtek Medical Electronics Co.,Ltd Bluetooth Blood Pressure Monitor LS808 BS FDA
LS808-BS FDA
User Manual
Blood Pressure Monitor LS808-BS
Please do read the user manual carefully and thoroughly so as to ensure
the safe usage of this product, and keep the manual well for your further
reference in case you have problems.
Thank you very much for selecting TRANSTEK Blood Pressure Monitor
LS808-BS.
Arm Type
Version:1.0
Guangdong Transtek Medical Electronics Co., Ltd.
Zone B, No.105 ,Dongli Road, Torch Development District,
Zhongshan,528437,Guangdong,China
FCC ID: OU9LS808-B-S
INTRODUCTION ................................................................ 2
Indications for Use
LCD Display Signal
Monitor Components
List
BEFORE YOU START ........................................................... 9
MEASUREMENT ............................................................... 16
INFORMATION FOR USER ...................................................... 22
Tips for Measurement
Maintenance
ABOUT BLOOD PRESSURE..................................................... 24
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?
TROUBLESHOOTING .......................................................... 26
SPECIFICATIONS .............................................................. 27
ATHORIZED COMPONENT ................................................ 28
CONTACT INFORMATION....................................................... 28
Safety Information
Power Supply and Charge Power
Setting the Time,Date and Unit
Start Measurement
DATA MANAGEMENT ..................................... 18
Recall the Records
Delete the Records
......................
COMPLIED EUROPEAN STANDARDS LIST ........................ 29
....................................................... 31......
Table of Contents
................
Measurement Principle
General Description
EMC GUDIANCE
Tie the Cuff
Pair up with Your Device
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?
Contraindications
FCC STATEMENT.............................................................. 30
1
TABLE OF CONTENTS
FEATURES:
86.1mm×24mm Blue LCD Display with White Backlight
Measure-during-inflating Technology
Up to 60 pieces of record stored per each user
This product uses the Oscillometric Measuring Method to detect blood pressure.
Before every measurement, the unit establishes a “zero point” equivalent to the
atmospheric pressure. Then it starts inflating the cuff. Meanwhile, the unit detects
pressure oscillation generated by beat-to-beat pulsatile, which is used to deter-
mine the systolic pressure and diastolic pressure as well as pulse rate.
Measurement Principle
General Description
The signs below might be in the user manual, labeling or other components.
They are the requirement of standard and using.
Safety Information
T1A/250V Φ3.6*10CCC
Indications for Use
* Thank you for selecting TRANSTEK blood pressure monitor (LS808-BS).
The monitor features blood pressure measurement, pulse rate measurement
and the result storage. The design provides you with two years of lifetime.
* This manual contains important safety information and caution, and provides step
by step instructions for using the product.
* Please do read this user manual carefully and thoroughly before 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.
Symbol for “ENVIRONMENT
PROTECTION - Electrical waste
products should not be disposed of
with household waste. Please recycle
where facilities exist. Check with your
local authority or retailer for recycling
advice”
SN
Symbol for “TYPE BF APPLIED
PARTS”
Symbol for “THE OPERATION
GUIDE MUST BE READ”
Symbol for “MANUFACTURER”
Symbol for “SERIAL NUMBER”
Symbol for “DIRECT CURRENT”
Symbol for “MANUFACTURE
DATE”
Caution: These notes must be
observed to prevent any damage
to the device.
Symbol for “Recycle”
The Green Dot is the license symbol
of a European network of
industry-funded systems for recycling
the packaging materials of consumer
goods.
Symbol for “Class II Equipment”
For indoor use only
F1
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,electrocical devices,
such as cardiac pacemakers, defibrillators.
Contraindications
INTRODUCTION INTRODUCTION
2 3
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 42.5℃ while the
environmental temperature is 40℃.
* The equipment is not AP/APG equipment and not suitable for use in the presence of a
flammable anesthetic mixture with air of with oxygen or nitrous oxide.
* Warning: No servicing/maintenance while the ME equipment is in use.
* The patient is an intended operator.
* The patient can measure,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!
INTRODUCTION INTRODUCTION
4 5
CAUTION
LCD Display Signal
Systolic
Blood Pressure High blood pressure
Diastolic
Blood Pressure Low blood pressure
Unit Measurement unit of blood pressure
Memory Query
Low Battery Low battery and please charge the
power.
Current time
Data pending to
transmit
Year/Month/Day(Hour:Minute)
Measurement data stored in the device
Data transmitting Data transmission succeeds.
User ID Start measurement for selected user,
and transmit the measuring result
Blood pressure monitor is detecting an
irregular heartbeat during measurement.
Irregular heartbeat
Heartbeat Blood pressure monitor is detecting a
heartbeat during measurement.
Motion indicator Motion may result in an inaccurate
measurement.
Pulse in beats per minute
Pulse display
Indicate it is in the memory mode and
which group of memory it is.
* 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.
INTRODUCTION INTRODUCTION
6 7
Monitor Components
1. The battery of LS808-BS is built-in rechargeable
li-polymer battery, the battery current is 1000 mAh.
2. Please use the AC adaptor to charge
the battery, just like the following picture:
Power Supply and Charge Power
Charging the power under following circumstances:
displays on the LCD
The LCD display is dim.
When powering on the monitor, the LCD doesn’t light up.
AC adaptor
CAUTION
* The battery of LS808-BS is built-in rechargeable lithium-ion battery,
please do not disassemble it by the unauthorized maintenance personel.
* Under the normal using, it can charge power about 300 times, if the
battery cannot charge the power normally or the blood pressure monitor
cannot use normally, please connect with the authorized maintenance
personel.If measured three times per day, and the battery is fully charged,
it can be used for about 20 days.
* Storge and use the blood pressure monitor at the cool, dry and ventilated
environment. Avoid to approach to the fire and the heat source, or it will
cause the battery explode.
* Only can use the Transtek’s authorized AC Adaptor (Model:
BLJ06L060100P-U) to charge the power. You cannot use the blood
pressure monitor during the process of charging.
* During the process of charging, the blood pressure monitor display
When the charging is finished, please pull the plug in time.
* When charging, shall not touch charging connector and the patient
simultaneously.
List
1.Blood Pressure Monitor
(LS808-BS)
2.AC Adaptor ( Model: BLJ06L060100P-U)
3.User Manual
4. Cuff (22cm-32cm or 22cm-42cm)
(Type BF Applied Part)
Component list of
pressure measuring system
1 PCBA
2 Air pipe
3 Pump
4 Valve
5 Cuff
SYSTOLIC PRESSURE
DIASTOLIC PRESSURE
QUERY/UP
BUTTON
USER 2/ACTIVATION
BUTTON
USER 1/SET
BUTTON
CUFF
(Type BF applied part)
PULSE RATE
ON/OFF BUTTON
DC POWER SOCKET
(Please use TRANSTEK
authorized cuff. The size
of the actual cuff please
refer to the label on the
attached cuff.)
BEFORE YOU START
8 9
INTRODUCTION
Setting the Time, Date and Unit
(1) When the monitor is off, press and hold User 1 button for 3s
to enter Time Setting Mode.
To ensure the stored measurement result has correct time
record, please set time and unit before device is used.
(2) As pictured in the right, the blinking numeral representing [HOUR].
Press “Query” button to change the numeral. Each press will increase
the numeral by one in a cycling manner.
(3) Press “User 1” button again to confirm [HOUR]. Then the numeral
representing [MINUTE] blinks.
Before use,switch the button to the “ON” side to turn on the monitor.
Note: If the button is on the “OFF” side, there is no reaction
when you press any button.
CAUTION
• Do not attempt to replace your blood pressure monitor’s battery. It is built-in
and not changeable.
• Only charge the battery in accordance with the user instructions supplied
with the blood pressure monitor.
• Avoid charging your blood pressure monitor in extremely high or low
temperatures.
• Do not use your blood pressure monitor while you are charging it.
• Do not attempt to disassemble the blood pressure monitor or force open the
built-in battery.
• Do not clean the blood pressure monitor when it is being charged. Always
unplug the charger first before cleaning the blood pressure monitor.
• Do not dispose of your blood pressure monitor in a fire. The battery could
explode causing injury or death.
• Batteries (battery pack or batteries installed) shall not be exposed to
excessive heat such as sunshine, fire or the like.
BEFORE YOU START
10 11
BEFORE YOU START
(4) Repeat steps 2 and 3 to confirm [MINUTE].
(5) Repeat steps 2 and 3 to confirm[MONTH], [DAY] and [YEAR].
(6) Repeat steps 2 and 3 to confirm the measurement unit.
(7) After confirming the measurement unit, the LCD will
display “dOnE” and the monitor will shut off.
12 13
BEFORE YOU START BEFORE YOU START
Tie the Cuff
1.
2.
3.
4.
5.
Remove all accessories (watch, bracelet,etc) from your arm. If your physician has
diagnosed you with poor circulation in your arm, use the other one.
Roll or push up your sleeve to expose the skin.
Apply the cuff to your arm with your palm facing up.
Position the edge of the cuff about 2cm~3cm from elbow.
Fasten the cuff around your arm, leaving no extra room between the cuff and your
skin. If the cuff is too loose, the measurement will not be accurate.
Sit comfortably with your tested arm resting on a flat surface. Place your elbow on a
table so that the cuff is at the same level as your heart. Turn your palm upwards.
Sit upright in a chair, and take 5-6 deep breaths.
Rest for 5 minutes before first measuring.
Wait at least 3 minutes between measurements. This allows your blood circulation to
recover.
The patient must relax as much as possible and do not move and talk during the
measurement procedure.
For a meaningful comparison, try to measure under similar conditions. For example,
take daily measurements at approximately the same time, on the same arm, or as
directed by a physician.
6.
7.
Take the measurement in a silent room.
The cuff should maintain at the same level as the right atrium of the heart.
Please sit comfortably. Do not cross your legs and keep your feet flat on the ground.
Keep your back against the backrest of the chair.
Helpful tips for Patients, especially for Patients with Hypertension:
Pair up the Blood Pressure Monitor
with Your Device
(2)Press “My devices”,the app will display My Devices tap.
Bluetooth Module No. : LS51802
Frequency Range
Output Power Range
Supply Voltage2.402 - 2.480 GHz
≤0 dBm
1.8-3.6 V
Transmitting Distance 10 meters
(5)After selecting the device,select the “account” and return;then enter
device to “Set device” .When the app display“Receive data
automatically”，please choose “Yes”.
(1) Turn on Bluetooth and the app. Enter to “MedM Health” then
press “My Setting” ,the app will display My Setting tap.
(4) Press in “MedM Health to reseach,then select “808A0”
to connect the monitor.
(3)When the moniter is off,press press“User 1” to measure,
the will show and will blink after measuring,then the datas
are transmitting.
(6)When the monitor is connected,the datas will transmit to “MedM”,
if transmit successfully,the symbel and will disappear,then the
monitor turn off;or not,it will turn off within one minute.
List of compatible devices:
For iOS devices:
The operating system must be iOS 8 or more, such as iPhone
4S, iPhone 5/5C/5S, iPhone 6/6 Plus and so on.
For Android devices:
The operating system must be 4.3 or more.
14 15
BEFORE YOU START BEFORE YOU START
Start Measurement
(1) When the monitor is off, press the User 1 button
to turn on the monitor.
LCD display Adjust to zero.
Inflating and measuring. Display and save the results.
The data transmission will proceed.
(2) Press User 1 button to power off,
otherwise it will turn off within one minute.
Tips:
A. When finish the whole measurement, press another
user button, the blood monitor will begin measuring again.
B. Maximum 60 records are both for user 1 and user 2.
1.With LS808-BS successfully pair-up with your mobile
device, the measurement data will be automatically
transmitted to your mobile device via Bluetooth.
2.The symbol will disappear after successful data
transmission, and you may check your personal health
data stored in your mobile device.
3.If the data transmission fails, the symbol will remain.
The pending measurement data will be transmitted to
your mobile device when next measurement is complete.
CAUTION
When the monitor is off, press User 1 button to turn
on the monitor and it will finish the whole measurement,
and then save the measure data for User 1.
The same to the User 2. (Take User 1 for example.)
(Note: Select the same user on your app and BPM to take
the measurement, or the measurement data won’t be
transmitted to the app.)
16 17
MEASUREMENT MEASUREMENT
Recall the Records
(1) When the monitor is off, press “Query” button
to access the memory.
(2) The LCD will display the latest measuring
result of the user ID which completes the last
measurement.
The record number, measuring date and measuring
time will be displayed alternatively.
(3) Press “Query” button to rotate the history records.
(4) When in the memory mode, press the User 1 button
to recall the measurement history of User 1, or press
the User 2 button to recall the measurement history.
(5) When no history stored for the specific user in the
monitor, press “Query” button and the LCD will display
as pictured to the right.
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.
CAUTION
18 19
DATA MANAGEMENT
DATA MANAGEMENT
Delete the Records
(1) When under the query mode, press and hold
“Query” button for 3 seconds to clear the memory.
(2) When the LCD display “dEL ALL”, press “Query”
button to confirm.
(3) The LCD will display “dEL dONE” and then shut off.
(4) If you wish to stop clearing the memory, you may
press the other button, rather than “Query” button to
turn off the monitor, or wait until the monitor shuts off.
CAUTION
.
• Interference may occur in the vicinity of equipment marked with the following
symbol .And LS808-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.
2120
DATA MANAGEMENT DATA MANAGEMENT
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
Maintenance
To obtain the best performance, please follow instructions below.
Measurements may be inaccurate if taken in the following
circumstances.
Put in a dry place and
avoid the sunshine
Avoid intense shaking and collisions.
Use the slightly damp cloth
to remove the dirt.
Avoid immersing it in the water.
Clean it with a dry cloth in case.
Avoid dusty environment and
unstable temperature surrounding
Avoid washing the cuff
22 23
INFORMATION FOR USER
INFORMATION FOR USER
What are systolic pressure and diastolic pressure?
press
artery vein
blood discharging
Systolic
relax
blood entering
Diastolic
When ventricles contract and pump blood out
of the heart, the blood pressure reaches its
maximum value in the cycle, which is called
systolic pressure. When the ventricles relax,
the blood pressure reaches its minimum
value in the cycle, which is called diastolic
pressure.
Irregular Heartbeat Detector
CAUTION
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.
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.
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.
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.
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.
What is the standard blood pressure classification?
The chart on the right is the
standard blood pressure classifi-
cation published by American
Heart Association (AHA).
AHA Home Guideline for
Upper Limit of Normal BP
Please consult a physician if your measuring result falls outside the range.
Please note that only a physician can tell whether your blood pressure value
has reached a dangerous point.
CAUTION
SYS 135 mm Hg
DIA 85 mm Hg
Blood Pressure Category
Normal
Prehypertension
High Blood Pressure
(Hypertension) Stage 1
High Blood Pressure
(Hypertension) Stage 2
Hypertensive Crisis
(Emergency care needed)
Systolic
mmHg (upper#)
Diastolic
mmHg (lower#)
less than 120
120-139
140-159
160 or higher
Higher than 180
and
or
or
or
or
less than 80
80-89
90-99
100 or higher
Higher than 110
This chart reflects blood pressure categories defined by American Heart Association.
ABOUT BLOOD PRESSURE ABOUT BLOOD PRESSURE
24 25
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.
3.7V 1000mAH Built-in rechargeable
li-polymer battery, 6V 1A AC Adaptor
Blue LCD with White Backlight
V.A.= 86.1mm(L) x24mm(W)
Approx.285g
Approx.130.9mm×73mm×29.4mm
AC Adaptor,user manual
A01
Power supply
Display mode
Measurement mode Oscillographic testing mode
Measurement range
Accuracy
Normal working condition
Storage & transportation
condition
Measurement perimeter
of the arm
Weight
External dimensions
Attachment
Mode of operation Continuous operation
Degree of protection Type BF applied part
Protection against
ingress of water
Software version
Device classification
Battery Powered Mode:
Internally Powered ME Equipment
AC Adaptor charged Mode:
Class II ME Equipment
WARNING: No modification of this equipment is allowed.
Pressure:
5°C-40°C within±3mmHg(0.4kPa)
Pulse value:±5%
Rated cuff pressure:
0mmHg~299mmHg(0kPa ~ 39.9kPa)
Measurement pressure:
SYS: 60mmHg~230mmHg (8.0kPa~30.7kPa)
DIA: 40mmHg~130mmHg (5.3kPa~17.3kPa)
Pulse value: (40-199)beat/minute
IP22: The first number 2: Protected against solid
foreign objects of 12,5mm Ф and greater. The second
number: Protected against vertically falling water
drops when enclosure titled up to 15º. Vertically falling
drops shall have no harmful effects when the
enclosure is titled at any angle up to 15º on either side
of the vertical.
About 22cm-32cm or 22cm-42cm
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
PROBLEM SYMPTOM CHECK THIS REMEDY
No power
Low
batteries
Error
message
Display will not
light up.
E1 shows The cuff is not secure.
E 3 shows
Relax for a moment
and then measure again.
E 10 or
E 11 shows
The monitor detected
motion,talking or the
pulse is too poor while
measuring.
E 20 shows
E 21 shows Relax for a moment and
then measure again.
EExx,shows on
the display.
A calibration error
occurred.
Retake the measurement.
If the problem persists,
contact the retailer or our
customer service
department for further
assistance.Refer to the
warranty for contact
information and return
instructions.
The measurement
process does not detect
the pulse signal.
Loosen the clothing on
the arm and then
measure again.
The treatment of the
measurement failed.
Power is exhausted. Charge the power
Power is low. Charge the power
Display is dim or
shows
AC adaptor is inserted
incorrectly.
Insert the AC adaptor
tightly
Refasten the cuff and then
measure again.
Warning
message “out ” shows Out of measurement
range
the measurement result is out of
the measurement range (SYS:
60mmHg to 230mmHg; or DIA:
40mmHg to 130mmHg;or
Pulse: 40-199 pulse/minute)
Relax for a moment
and then measure again.
The pressure of the
cuff is excess.
TROUBLESHOOTING SPECIFICATIONS
26 27
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.
Contact Information
Athorized Component
Please use the TRANSTEK
authorized adaptor
Manufactured by:
Company:
Address:
Guangdong Transtek Medical Electronics Co., Ltd.
Zone B, No.105 ,Dongli Road, Torch Development District,
Zhongshan,528437,Guangdong,China
Guangdong Transtek Medical Electronics Co., Ltd.
BLJ06L060100P-U
100-240V 50-60Hz,0.2Amax
6V 1000mA
Adaptor
Type:
Input:
Output:
Complied Standards List
EN ISO 14971:2012 / ISO 14971:2007 Medical devices -
Application of risk management to medical devices
EN 1041:2008 Information supplied by the manufacturer of medical
devices
EN 60601-1:2006+A1:2013/ IEC 60601-1:2005+A1:2012 Medical
electrical equipment - Part 1: General requirements for basic safety
and essential performance
EN 60601-1-11:2015/ IEC 60601-1-11:2015 Medical electrical
equipment - Part 1-11: General requirements for basic safety and
essential performance - Collateral standard: Requirements for medical
electrical equipment and medical electrical systems used in the home
healthcare environment
EN 60601-1-2:2015/ IEC 60601-1-2:2014 Medical electrical
equipment - Part 1-2: General requirements for basic safety and
essential performance - Collateral standard: Electromagnetic
disturbances - Requirements and tests
EN ISO 81060-1:2012 Non-invasive sphygmomanometers - Part 1:
Requirements and test methods for non-automated measurement type
EN 1060-3:1997+A2:2009 Non-invasive sphygmomanometers -
Part 3: Supplementary requirements for electro-mechanical blood
pressure measuring systems
EN 1060-4:2004 Non-invasive sphygmomanometers - Part 4: Test
procedures to determine the overall system accuracy of automated
non-invasive sphygmomanometers
EN 60601-1-6:2010+A1:2015/IEC 60601-1-6:2010+A1:2013
Medical electrical equipment - Part 1-6: General requirements for basic
safety and essential performance - Collateral standard: Usability
IEC 62366-1:2015 Medical devices - Part 1: Application of
usability engineering to medical devices
EN 62304:2006/AC: 2008 / IEC 62304: 2006+A1:2015 Medical
device software - Software life-cycle processes
Risk management
Labeling
User manual
General Requirements
for Safety
Electromagnetic
compatibility
Performance
requirements
Clinical investigation
Usability
Software life-cycle
processes
Bio-compatibility
ISO 10993-1:2009 Biological evaluation of medical devices- Part
1: Evaluation and testing within a risk management process
ISO 10993-5:2009 Biological evaluation of medical devices -
Part 5: Tests for in vitro cytotoxicity
ISO 10993-10:2010 Biological evaluation of medical devices -
Part 10: Tests for irritation and skin sensitization
EN ISO 15223-1:2016 / ISO 15223-1:2016 Medical devices.
Symbols to be used with medical device labels, labelling and
information to be supplied. Part 1 : General requirements
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
ISO 81060-2:2013 Non-invasive sphygmomanometers - Part 2:
Clinical validation of automated measurement type
COMPLIED STANDARDS LIST
28 29
ATHORIZED COMPONENT
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
RF emissions
CISPR 11 Group 1
Class B
Class A
Complies
Compliance
Harmonic emissions
IEC 61000-3-2
Voltage fluctuations/
flicker emissions
IEC 61000-3-3
RF emissions
CISPR 11
Emissions test Electromagnetic environment - guidance
The device 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.
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.
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.
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.
FCC Statement
FCC ID: OU9LS808-B-S
FCC STATEMENT
30 31
EMC GUIDANCE
Guidance and manufacturer’s declaration – electromagnetic immunity
Immunity test
±8 kV contact
±15 kV air ±8 kV contact
±15 kV air
±2 kV
power supply lines:
line(s) to line(s): ±1 kV
line(s) to earth: ±2 kV
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
30 A/m
50Hz/60Hz
NOTE U
T
is the a.c. mains voltage prior to application of the test level.
Table 2
Compliance level
Electrostatic
discharge (ESD)
IEC 61000-4-2
Electromagnetic
environment - guidance
30 A/m
50Hz/60Hz
Power frequency
(50Hz/60Hz)
magnetic field
IEC 61000-4-8
Voltage dips,
short interruptions
and voltage
variations on
power supply
input lines
IEC 61000-4-11
Electrical fast
transient/burst
IEC 61000-4-4
Surge
IEC61000-4-5
input/output lines:
±1 kV
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.
IEC 60601 test level
Floors should be wood, concrete
or ceramic tile. If floors are
covered with synthetic material,
the relative humidity should be at
least 30%.
±2 kV
power supply lines:
100 kHz repetition
frequency
line(s) to line(s): ±1 kV
100 kHz repetition
frequency
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.
Power frequency magnetic fields
should be at levels characteristic
of a typical location in a typical
commercial or hospital
environment.
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
Table 3
Guidance and manufacturer’s declaration – electromagnetic immunity
Immunity test Compliance
level
IEC 60601
Test level
Conducted RF
IEC 61000-4-6
Radiated RF
IEC 61000-4-3
10V/m, 80% Am
at 1kHz
150 kHz to
80 MHz:
3 Vrms
6Vrms (in ISM
and amateur
radio bands)
80% Am at 1kHz
Electromagnetic environment - guidance
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.
aField 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.
Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3V/m.
b
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.
150 kHz to
80 MHz:
3 Vrms
6Vrms (in ISM
and amateur
radio bands)
80% Am at 1kHz
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 ;
d=1.2
10V/m, 80% Am
at 1kHz
80 MHz to 800 MHz:
d=1.2
800 MHz to 2.7 GHz:
d=2.3
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:
P
P
P
P
EMC GUIDANCE
32 33
EMC GUIDANCE
150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2.7 GHz
Table 4
Recommended separation distances between portable and mobile RF communications
equipment and the device.
Rated maximum output
power of transmitter
(W)
Separation distance according to frequency of transmitter (m)
0.01
0.1
1
10
100
0.12 0.12
0.38
1.2
3.8
12
0.23
0.73
2.3
7.3
23
=d =d 1.2 2.3=d
0.37
1.2
3.8
12
3.5
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.
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.
PPP
EMC GUIDANCE
Table 5
Guidance and manufacturer’s declaration - electromagnetic immunity
Test
Frequency
(MHz)
385 0.3 27
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.
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.
Radiated RF
IEC61000-4-3
(Test
specifications
for
ENCLOSURE
PORT
IMMUNITY to
RF wireless
communicatio
ns equipment)
Band a)
(MHz)
Service a) Modulation b) Modulation b)
(W)
Distance (m)
IMMUNITY
TEST
LEVEL
(V/m)
380-390 TETRA
400
Pulse
modulation b)
18Hz
1.8
450 380-390
GMRS 460，
FRS 460
FM c) ± 5kHz
deviation 1kHz
sine
20.3 28
710 704-787
745
780
LTE Band
13,
17
Pulse
modulation b)
217Hz
0.2 0.3 9
810
870
930
800-960
GSM
800/900,
TETRA 800,
iDEN 820,
CDMA 850,
LTE Band 5
Pulse
modulation b)
18Hz
20.3 28
1720
1845
1970
1700-
1990
GSM 1800;
CDMA 1900;
GSM 1900;
DECT;
LTE Band 1,
3,
4,25; UMTS
Pulse
modulation b)
217Hz
20.3 28
20.3 282450 2400-
2570
Bluetooth,
WLAN,
802.11
b/g/n, RFID
2450, LTE
Band 7
Pulse
modulation b)
217 Hz
5240
5240
5785
5100-
5800
WLAN
802.11
a/n
Pulse
modulation b)
217 Hz
0.2 0.3 9
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.
34 35
EMC GUIDANCE