Transtek Medical Electronics LS810-BS1 Blood Pressure Monitor User Manual
Guangdong Transtek Medical Electronics Co.,Ltd Blood Pressure Monitor Users Manual
Users Manual
User Manual
Blood Pressure Monitor LS810-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
LS810-BS.
Wrist Type
Version:1.0
Guangdong Transtek Medical Electronics Co., Ltd.
Zone B, No.105 ,Dongli Road, Torch Development District,
Zhongshan,528437,Guangdong,China
MEM
SET
1
INTRODUCTION .............................................................2
Indications for Use
LCD Display Signal
Monitor Components
List
BEFORE YOU START ........................................................9
MEASUREMENT .............................................................
13
INFORMATION FOR USER .................................................... 18
Tips for Measurement
Maintenance
ABOUT BLOOD PRESSURE....................................................20
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 wrist?
TROUBLESHOOTING .........................................................22
SPECIFICATIONS ............................................................. 23
THE MATCHED COMPONENTS ............................................... 24
CONTACT INFORMATION...................................................... 24
Safety Information
Power Supply and Charge Power
Setting Date and Time
Tie the Cuff
Start Measurement
Data Management .................................. 16
Recall the Records
Delete the Records
.........................
COMPLIED STANDARDS LIST .................................. 26
Table of Contents
...............
Measurement Principle
General Description
EMC GUDIANCE ...................................................... 27......
Table of Contents
Activate Your Blood Pressure Monitor
FCC STATEMENT ............................................................. 25
INTRODUCTION INTRODUCTION
FEATURES:
Systolic Blood Pressure
Diastolic Blood Pressure
Pulse Rate
Memory: Up to 60 pieces of records
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
23
Indications for Use
The Transtek Blood Pressure Monitor is digital monitors intended for use in
measuring blood pressure and heartbeat rate with wrist circumference ranging
from 13.5 cm to 21.5 cm ( about 5-8.5 inches ).
It is intended for adult indoor use only.
Thank you for selecting TRANSTEK blood pressure monitor (LS810-BS).
The monitor features blood pressure measurement, pulse rate measurement
and the result storage. The design provides you with two years of lifetime.
Readings taken by the LS810-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.
Please do read this user manual carefully and thoroughly before use.
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
T1A/250V Φ3.6*10CCC Symbol for “Including RF
transmitter”
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.
INTRODUCTION INTRODUCTION
45
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 wrist or for functions other than obtaining a blood
pressure measurement.
* Do not confuse self-monitoring with self-diagnosis. This unit allows you to monitor your blood pressure.Do not
begin or end medical treatment without asking a physician for treatment advice.
* If you are taking medication,consult your physician to determine the most appropriate time to measure your
blood pressure. Never change a prescribed medication without consulting your physician.
* Do not take any therapeutic measures on the basis of a self measurement. Never alter the dose of a
medicine prescribed by a doctor. Consult your doctor if you have any question about your blood pressure.
* When the device was used to measure patients who have common arrhythmias such as atrial or ventricular
premature beats or atrial fibrillation, the best result may occur with deviation. Please consult your physician
about the result.
* 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 wrist
where intravascular access or therapy, or an arterio-venous (A-V) shunt, is present; inflating the cuff on the
side of a mastectomy.
* Warning: Do not apply the cuff over a wound;otherwise it can cause further injury.
*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 wrist 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.
* The ACCOMPANYING DOCUMENT shall disclose that the SPHYGMOMANOMETER was clinically
investigated according to the requirements of ISO 81060-2:2013.
* To verify the calibration of the AUTOMATED SPHYGMOMANOMETER, please contact the manufacturer.
* This device is contraindicated for any female who may be suspected of, or is pregnant. Besides providing
inaccurate readings, the effects of this device on the fetus are unknown.
* Too frequent and consecutive measurements could cause disturbances in blood circulation and injuries.
* This unit is not suitable for continuous monitoring during medical emergencies or operations.Otherwise, the
patient’s wrist and fingers will become anaesthetic, swollen and even purple due to a lack of blood.
* When not in use, store the device 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.
CAUTION
* 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 wrist or other complaints, press
the START/STOP button to release the air immediately from the cuff. Loosen the cuff and remove it from
your wrist.
* If the cuff pressure reaches 40 kPa (300 mmHg), the unit will automatically deflate. Should the cuff not
deflate when pressures reaches 40 kPa (300 mmHg), detach the cuff from the wrist and press the
START/STOP button to stop inflation.
* Before use, make sure the device functions safely and is in proper working condition. Check the device,
do not use the device if it is damaged in any way. The continuous use of a damaged unit may cause
injury, improper results, or serious danger.
* Do not wash the cuff in a washing machine or dishwasher!
* The service life of the cuff may vary by the frequency of washing, skin condition, and storage state. The
typical service life is 10000 times.
* It is recommended that the performance should be checked every 2 years and after maintenance and
repair, by retesting at least the requirements in limits of the error of the cuff pressure indication and air
leakage (testing at least at 50mmHg and 200mmHg).
* Please dispose of ACCESSORIES, detachable parts, and the ME EQUIPMENT according to the local
guidelines.
* Manufacturer will make available on request circuit diagrams, component part lists, descriptions,
calibration instructions,etc., to assist to service personnel in parts repair.
* The 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.
INTRODUCTION INTRODUCTION
6
LCD Display Signal
7
CAUTION
* 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.
* There is a PTC current limiter in the monitor, which specification is 8V and 0.5A. When the voltage and
current exceed the limiting value, the monitor will stop working.
Systolic
Blood Pressure High blood pressure
Diastolic
Blood Pressure Low blood pressure
Unit Measurement unit of blood pressure
(1 mmHg=0.133 kPa)
Time Hour:Minute (Month/Day/Year)
Low Battery Low battery and please charge the
power.
Memory
Pulse in beats per minute
Pulse display
Heartbeat Blood pressure monitor is detecting a
heartbeat during measurement.
Indicate it is in the memory mode and
which group of memory it is.
Irregular heartbeat Blood pressure monitor is detecting an
irregular heartbeat during measurement.
SYSTOLIC
DIASTOLIC
MEM/UP
BUTTON
SET/DOWN
BUTTON
START/STOP BUTTON
CUFF
(Type BF applied part)
PULSE RATE
TIME
USB Interface
Monitor Components
List
1.Blood Pressure Monitor
(LS810-BS)
2.USB Cable and AC Adaptor
3.User Manual
8
1. The battery of LS810-BS is built-in rechargeable
lithium-ion battery, the battery current is 420 mAh.
2. Please use the AC adaptor and USB cable 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 dims
When powering on the monitor, the LCD doesn’t light up.
AC adaptor
9
Component list of
pressure measuring system
1 PCBA
2 Air pipe
3 Pump
4 Valve
5 Cuff
BEFORE YOU START
INTRODUCTION
CAUTION
* The battery of LS810-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:BLJ06L050100U-S,BLJ06L050100U-B,BLJ06L050100U-U,
BLJ06L050100U-V) 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.
MEM
SET
( Model: BLJ06L050100U-S,
BLJ06L050100U-B,
BLJ06L050100U-U,
BLJ06L050100U-V)
10 11
Activate Your Blood Pressure Monitor
When you get the Blood Pressure Monitor, the first thing
you must do is to activate it.Please press and hold the SET
button to activate it,then it will enter the setting mode.
BEFORE YOU START
CAUTION
BEFORE YOU START
• 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.
Setting Date and Time
2.As pictured in the right, the
blinking numeral representing
[HOUR]. Press “MEM” button to
change the numeral. Each press
will increase the numeral by one
in a cycling manner.
1.When the monitor is OFF, press
and hold “SET” button for 3
seconds to enter Time Setting
Mode.
3.Press “SET” button again to
confirm [HOUR]. Then the
numeral representing [MINUTE]
blinks.
Please proceed to time setting before your initial use so as to
ensure each piece of record are labled with a time stamp. (Year
Range: 2012-2052; Time Format: 12 Hours)
12 13
MEM
SET
MEASUREMENTBEFORE YOU START
Tie the Cuff
1.
2.
3.
4.
5.
Remove all accessories (watch, bracelet,etc) from your wrist. If your
physician has diagnosed you with poor circulation in your wrist, use the
other one.
Roll or push up your sleeve to expose the skin.
Apply the cuff to your wrist with your palm facing up.
Position the edge of the cuff about 1cm~2cm from wrist joints.
Fasten the wrist cuff around your wrist, leaving no extra room between
the cuff and your skin. If the cuff is too loose, the measurement will not
be accurate.
Sit comfortably with your tested wrist resting on a flat surface. Place
your elbow on a table so that the cuff is at the same level as your
heart. Turn your palm upwards. Sit upright in a chair, and take 5-6
deep breaths.
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 wrist, 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:
4.Repeat step 2 and 3 to confirm
[MINUTE].
5.Repeat step 2 and 3
to confirm [MONTH],
[DAY] and [YEAR].
6.After confirming [YEAR], the LCD
will display “doNE” and the
monitor will shut off.
14 15
MEASUREMENTMEASUREMENT
Adjust the zero.
Inflating and measuring. Display and save the
measuring result.
START
STOP
1.After correctly positioning the cuff,
press START button to turn on the
monitor, and it will complete the
measurement process.
Start Measurement
4.Press STOP button to turn off
the monitor. Otherwise it will
power off.
2.This device will proceed
to data transmission
after measurement.
The symbol
blinks on the LCD
indicates data is
transmitting.
3.If the data is successfully
transmitted, the LCD will then
display “ ”and“dONE”.
If the data transmission fails, the
LCD will display “ ”and “ Err ” instead.
CAUTION
1.
2.
Interference may occur in the vicinity of equipment marked with the following
symbol . And LS810-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?
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.
To avoid interference, other electronic devices (particularly those with
wireless transmission / Transmitter) should be kept at least 1 meter away
from the monitor.
16 17
DATA MANAGEMENT DATA MANAGEMENT
Recall the Records
1.Press “MEM” button to access the
memory. The monitor will display the
calculated value of the latest
readings first.
2. Press “MEM/UP” button or
“SET/DOWN” button to rotate the
history records.
“MEM/UP” to go forward;
“SET/DOWN” to go backward.
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
When you did not obtain the accurate measurement, you can clear all the
measuring results by following steps below.
Delete the Records
1.Under Memory Recalling Mode, press
and hold both the “MEM” button and the
“SET” button for 3 seconds.
2.The LCD will display “dEL dONE”,
indicating that memory clearing is
complete.And then it will shutdown.
Under Memory Recalling Mode, if you
wish to give up clearing, press
“START/STOP” to turn off the monitor.
3.When there is no memory in the monitor,
if you press the “MEM” button to look up
history, the LCD will display as pictured
to the right.
CAUTION
Bluetooth Module No.:AW2540
RF Frequency Range:2402~2480MHz
Supply Voltage:3.3V
Transmitting Distance:10M
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.
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
MEM
SET
MEM
SET
MEM
SET
18
Maintenance
To obtain the best performance, please follow the instructions below.
Put in a dry place and
avoid the sunshine
Avoid 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
MEM
SET
MEM
SET
MEM
SET
19
Measurements may be inaccurate if taken in the following
circumstances.
INFORMATION FOR USER INFORMATION FOR USER
2120
Why does my blood pressure
fluctuate throughout the
day?
MEM
SET
MEM
SET
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.
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 wrist.
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.
It is ok for both wrists, but there will
be some different results for different
people. We suggest you measure the
same wrist every time.
Why do I get a different
blood pressure at home
compared to the hospital?
Is the result the same if
measuring on the right
wrist?
ABOUT BLOOD PRESSURE ABOUT BLOOD PRESSURE
What are systolic pressure and diastolic pressure?
press
artery vein
blood discharging
Systolic
relax
blood entering
Diastolic
What is the standard blood pressure classification?
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
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
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
120-129
130-139
140 or higher
Higher than 180
and
or
or
and/or
less than 80
80-89
90 or higher
Higher than 120
This chart reflects blood pressure categories defined by American Heart Association.
An irregular heartbeat 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 thanthe average
value of ±15%,the irregular heartbeat symbol appears on the display when the
measurement results are appear.
and less than 80
22
Power supply 3.7V 420mAH Built-in rechargeable lithium-ion
battery, 5V 1A USB AC Adaptor
Display mode Digital LCD V.A.46.5mmx36.5mm
Measurement mode Oscillographic testing mode
Measurement range
Accuracy
Normal working condition
Storage & transportation
condition
Measurement perimeter
of the wrist About 13.5cm-21.5cm
Weight Approx.110g
External dimensions
Attachment
Approx.79.8mm×72.5mm×13.2mm
USB cable, AC Adaptor,user manual
Mode of operation Continuous operation
Degree of protection Type BF applied part
Protection against
ingress of water
IP22, It means the device could protected
against solid foreign objects of 12.5 mm and
greater, and against vertically falling water
drops when ENCLOSURE tilted up to 15°
Software version
Device classification
V01 004
Battery Powered Mode:
Internally Powered ME Equipment
WARNING: No modification of this equipment is allowed.
Pressure:
5℃-40 ℃within±3mmHg(0.4kPa)
pulse value:±5%
AC Adaptor charged Mode:
Class II ME Equipment
23
SPECIFICATIONSTROUBLESHOOTING
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
This section includes a list of error messages and frequently
asked questions for problems you may encounter with your blood
pressure monitor. If the products not operating as you think it
should, check here before arranging for servicing.
PROBLEM SYMPTOM CHECK THIS REMEDY
No power
Low
batteries
Error
message
Display is dim or
will not light up. Power is exhausted.
Charge the power.
Show on
the display Power is low.
E 2 shows
Relax for a moment
and then measure again.
Movement can affect the
measurement.Relax for a
moment and then
measure again.
E 3 shows
E 4 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.
Charge the power.
The cuff is not secure or
very tigh.
E 1 shows Refasten the cuff and then
measure again.
“out” shows
Out of measurement
range
The treatment of the
measurement failed.
The monitor detected
motion,talking or the
pluse is too poor
while measuring.
(Excluding the dry cells)
Temperature:-20°C to +60°C
A relative humidity range of ≤ 93%, non-condensing,
at a water vapour pressure up to 50hPa
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
24
25
Please use the TRANSTEK
authorized adaptor
100-240V, 50-60Hz,0.18A
5.0V 1.0A
Adaptor
Type:
Input:
Output:
The Matched Component
THE MATCH COMPONENT FCC STATEMENT
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
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.
FCC Statement
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 ID:OU9LS810-BS1
BLJ06L050100U-S,
BLJ06L050100U-B,
BLJ06L050100U-U,
BLJ06L050100U-V
EMC GUIDANCE
26 27
COMPLIED STANDARDS LIST
Complied Standards List
EN ISO 14971:2012 / ISO 14971:2007 Medical devices -
Application of risk management to medical devices
EN 1041:2008 Information supplied by the manufacturer of medical
devices
EN 60601-1:2006/ IEC 60601-1:2005+A1:2012 Medical electrical
equipment - Part 1: General requirements for basic safety and
essential performance
EN 60601-1-11:2015/ 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/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/ IEC 62366-1:2015 Medical devices - Part 1:
Application of usability engineering to medical devices
EN 62304:2006/AC: 2008 / IEC 62304:2006 Medical device
software - Software life-cycle processes
Risk management
Labeling
User manual
General Requirements
for Safety
Electromagnetic
compatibility
Performance
requirements
Clinical investigation
Usability
Software life-cycle
processes
Bio-compatibility
ISO 10993-1:2009 Biological evaluation of medical devices- Part
1: Evaluation and testing within a risk management process
ISO 10993-5:2009 Biological evaluation of medical devices -
Part 5: Tests for in vitro cytotoxicity
ISO 10993-10:2010 Biological evaluation of medical devices -
Part 10: Tests for irritation and skin sensitization
EN ISO 15223-1:2016 / ISO 15223-1:2016 Medical devices.
Symbols to be used with medical device labels, labelling and
information to be supplied. Part 1 : General requirements
IEC 80601-2-30:2013 Medical electrical equipment- Part 2-30:
Particular requirements for the basic safety and essential
performance of automated non-invasive sphygmomanometers
ISO 81060-2:2013 Non-invasive sphygmomanometers - Part 2:
Clinical validation of automated measurement type
EMC Guidance
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.
28
EMC GUIDANCE
29
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
30 31
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
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.