User Manual
Version:1.0
Blood Pressure Monitor
LS802-E
Arm Type
FCC ID:OU9LS802-E02
GUANGDONG TRANSTEK MEDICAL ELECTRONICS CO.,LTD
Zone A, 5/F., Investment Building, No. 12, Huizhan East Rd., Torch
Development District, Zhongshan, Guangdong, 528437, China
Thank you very much for selecting TRANSTEK Blood Pressure Monitor
LS802-E.
To use the monitor correctly and safely, please read the manual
thoroughly.
please keep well this manual in order to reference in future.
CATALOGUE
CATALOGUE
Table of Contents
INTRODUCTION..............................................................................................................................2
General Description
Safety Information
LCD Display Signal
Monitor Components
BEFORE YOU START......................................................................................................................6
The Choice of Power Supply
Installing and Replacing the Batteries
MEASUREMENT..............................................................................................................................8
Tie the Cuff
Start the Measurement
INFORMATION FOR USER...........................................................................................................10
Tips for measurement
Maintenances
ABOUT BLOOD PRESSURE.........................................................................................................12
What are systolic pressure and diastolic pressure?
What is the standard blood pressure classification?
Why my blood pressure is varies even in one day?
Why the blood pressure I get from the hospital is different from home?
If the result is the same if measuring on the right arm?
TROUBLESHOOTING ...................................................................................................................14
SPECIFICATIONS..........................................................................................................................15
AUTHORIZED COMPONENTS ....................................................................................................16
CONTACT INFORMATION.............................................................................................................16
FCC STATEMENT...........................................................................................................................17
COMPLIED STANDARDS LIST.....................................................................................................18
EMC GUIDANCE............................................................................................................................19
1
INTRODUCTION INTRODUCTION
CAUTION
General Description
Thank you for selecting TRANSTEK arm type blood pressure Monitor (LS802-E).
The monitor features blood pressure measurement, pulse rate measurement and the
the result storage. The design provides you with two years of reliable service.
Reading taken by the LS802-E are equivalent to those obtained by a trained
observer using the cuff and stethoscope auscultation method.
This manual contains important safety and care information, and provides step
by step instruction for using the product.
Read the manual thoroughly before using the product.
Features:
92*78mm Blue LCD display with white backlight
Maximum 60 records per each user
Measuring during inflation technology
Safety Information
The below signs might be in the user manual, labeling or other component.
they are the requirement of standard and using.
Symbol for “THE OPERATION
GUIDE MUST BE READ”
Wireless Transmission
Symbol for “MANUFACTURER”
Symbol for “SERIAL NUMBER”
For indoor use only
T1A/250V Φ3.6*10CCC
F1
Symbol for “TYPE BF APPLIED
PARTS”
Symbol for “MANUFACTURE
DATE”
Symbol for “DIRECT CURRENT”
Symbol for “Class II Equipment”
Symbol for “ENVIRONMENT
PROTECTION – Waste electrical
products should not be disposed of
with household waste. Please follow
local guidelines.”
This device is intended for adult use only.
This device is intended for no-invasive measuring and monitoring of arterial blood pressure.
It is not intended for use on extremities other than the arm or for functions other than obtaining a
blood pressure measurement.
Do not confuse self-monitoring with self-diagnosis. This unit allows you to monitor your blood
pressure.Do not begin or end medical treatment based solely physician for treatment advice.
If you are taking medication,consult your physician to determine the most appropriate time to
measure your blood pressure. Never change a prescribed medication without consulting your
Physician.
When the device was used to measure patients who have common arrhythmias such as atrial or
ventricular premature beats or artrial fibrillation, the best result may occure deviation. Please
consult your physician about the result.
If the cuff pressure exceeds 40 kPa (300 mmHg), the unit will automatically deflate. Should the
cuff not deflate when pressures exceeds 40 kPa (300 mmHg), detach the cuff from the armand
press the START/STOP button to stop inflation.
The equipment is not AP/APG equipment and not suitable for use in the presence of a flammable
anesthetic mixture with air of with oxygen or nitrous oxide.
The operator shall not touch output of batteries /adapter and the patient simultaneously.
To avoid measurement errors, please avoid the condition of strong electromagnetic field radiated
interference signal or electrical fast transient/burst signal.
The user must check that the equipment functions safely and see that it is in proper working
condition before being used.
This device is contraindicated for any female who may be suspected of, or is pregnant. Besides
provided inaccurate readings, the affects of this device on the fetus are unknown.
Manufacturer will make available on request circuit diagrams, component parts list etc.
This unit is not suitable for continuous monitoring during medical emergencies or operations.
Otherwise, the patient’s arm and fingers will become anaesthetic, swollen and even purple due to
a lack of blood.
Please use the device under the environment which was provided in the user manual. Otherwise,
the performance and lifetime of the device will been impacted and reduced.
During using, the patient will contact with the cuff. The materials of the cuff have been tested and
found to comply with requirements of ISO 10993-5:2009 and ISO 10993-10:2010. It will not
cause any potential sensization or irritation reaction.
Please use ACCESSORIES and detachable partes specified/ authorised by MANUFACTURE.
Otherwise, it may cause damage to the unit or danger to the user/patients.
The device doesn’t need to be calibrated in two years of reliable service.
Please dispose of ACCESSORIES, detachable parts, and the ME EQUIPMENT according to the
local guidelines.
If you have any problems with this device, such as setting up, maintaining or using, please
contact with SERVICE PERSONNEL of Transtek. Don’t open or repair the device by yourself.
Please report to Transtek if any unexpected operation or events occur.
Please use the soft cloth to clean the whole unit. Don’t use any abrasive or volatile cleaners.
The device has been evaluated clinically used manual cuff/stethoscope ausculation as the
reference. Blood pressure measurements determined with this device are equivalent to those
obtained by a trained observer using the cuff/stethoscope auscultatory method, within the limits
prescribed by the American National Standard, Manual, electronic, or automated
sphygmomanometers.”
2 3
INTRODUCTION
INTRODUCTION
LCD Display Signal
SYMBOL DESCRIPTION
Systolic blood pressure High pressure result
Diastolic blood pressure Low pressure result
Pulse Pulse/minute
User 1 Provide measurement for user 1, and
Guest
User 2
Data storage
Wireless transmitter
Network connection The bridge not connect the network
Shocking remainding Shocking will result in inaccurate
Low battery Batteries are low and need to be replaced
Unit
date (hour:minute) Currently time
Deflating
Arrhythmia Irregular heartbeat
4
Heartbeat Heartbeat detection during the measurement
EXPLANATION
then save the measure data
Provide measurement for guests,
but not save the measurement data.
Provide measurement for user 2, and
then save the measure data
To remind the users that the measurement
data don’t upload to bridge in time
The blood monitor and Bridge in communication
Measurement Unit of the blood pressure
CUFF air is exhausting of deflating
Monitor Components
CUFF
AIR PIPE
AIR CONNECTOR PLUG
User 2
Guest
User 1
Component list of
pressure measuring system
1 Cuff
2 Air pipe
3 PCBA
4 Pump
5 Valve
List
1.Blood Pressure Monitor
(LS802-E)
2.Cuff (Type BF applied part)
4.User manual3. 4*AA alkaline batteries
LCD DISPLAY
DC POWER SOCKET
BATTERY COMPARTMENT
(22~32cm or 22cm~42cm)
5. AC Adaptor
(UE08WCP-060100SPA only!)
5
BEFORE YOU START
MEASUREMENT
The Choice of Power Supply
1.Battery powered mode:
6VDC 4*AA alkaline batteries
2.AC adaptor powered mode:
100-240V~, 50-60HZ,400mA
(Can be supplied by AC adaptor model
UE08WCP-060100SPA only!)
Please unplug the adaptor to depart from
the using utility power.
Note:
The adaptor interface is located on the right side of the monitor.
Place NO obstacles on the right for easy pull-off adaptor.
AC adaptor
CAUTION
In order to get the best effect and protect you monitor,please use the right
battery and special power adapter which complies with U.S. safety standard.
Installing and Replacing the Batteries
１.Slide off the battery cover.
２.Install the batteries by matching
the correct polarity, as shown.
３.Replace the cover.
Replace the batteries whenever the below happen
The + shows
The display dims
The display does not light up
CAUTION
Remove batteries if the device is not likely to be used for some time.
The old battery is harmful to the environment, so please disposal with other daily trash.
Remove the old battery from the device and follow your local recycling guidelines.
Do not dispose of batteries in fire. Batteries may explode or leak.
Tie the Cuff
1.Tie the cuff on your upper arm,
the position the tube off-center
toward the inner side of arm in
line with the little finger.
2.The cuff should be sung but not
too tight. You should be able to
insert one finger between the
cuff and your arm.
3.Sit comfortably with your tested
arm resting on a flat surface.
4.Correct Posture for Patients with
Hypertension, especially for
Hypertension patient
- Bare your arm or wear tights only
when starting measurement.
- Sit comfortably with legs
uncrossed, feet flat on the floor,
back and arm supported.
The central of the cuff should
maintain at the same level as the
right atrium of the heart.
Resting for 5 minutes before
measuring.
Wait at least 3 minutes between
measurements. This allows your
blood circulation to recover.
For a meaningful comparison,
try to measure under similar
conditions. For example, take daily
measurements at approximately
the same time, on the same arm,
or as directed by a physician.
2~3cm
6
7
MEASUREMENT MEASUREMENT
Start the Measurement
Please proceed to activate/synchronize before initial use of this equipment or when
Press the 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.
Press the Guest button to turn on the monitor and it will finish the whole
measurement for Guest, but not save the measurement data.
In this manual, the measurement of User 1 as an example.
1. When the monitor is off,
press the User 1 button to turn on the monitor.
Adjust the zero . If the
measure data don’t upload to
LCD display
Inflating and measuring.
When there is
no record
the bridge in time, the icon
will display.
Display and save the results will
transmit to the bridge through the
wireless.
3
the measurement unit is changed. When the equipment is OFF, press and hold
“GUEST” button to enter Activation / Synchronization Interface. After successful
activation/synchronization, the equipment will display and transmit the measuring
results after each measurement.
Activation
/synchroniz
ation is
proceeding
Wireless Transmission
Module No.
Frequency Range Output Power Range
915 - 918.5 MHz +1 dBm
Supply VoltageAW4431_915
The
measureme
-nt data is
uploading
The data
has been
uploaded
successfully
3.3V
CAUTION
Interference may occur in the vicinity of equipment marked with the following symbol
. And LS802-E may interfering vicinity electrical equipment.
Sensitive people, including pregnant women 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 interconnected with
Bridge in RF 915 MHz network.
2.
Press the User 1 to power off , otherwise it
will turn off within one minute.
Tips:
A.when finish the whole measurement, press another button ,the blood
monitor will begin measure again.
B.If the blood monitor not connect with bridge, the icon of will display.
Maximum 60 records are both for User 1 and User 2.
8
How to mitigate possible interference?
1. The range between the device and the Bridge should be reasonably close, from 1
meter to 10 meters. Please ensure no obstacles between the device and the Bridge
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.
9
INFORMATION FOR USER
INFORMATION FOR USER
Tips for measurement
It can cause incorrectness if the measurement are taken in the
following circumstances.
Within 1 hour
after dinner or drinking
Within 20 minutes
after taking a bath
Immediate measurement
after tea, coffee, smoking
When talking or moving your fingers
Maintenance
In order to get the best performance, please follow the below
instructions.
Put in a dry place and avoid the sunshine
Avoid the intense shaking
and collision
Avoid touching water,
clean it with a dry cloth in case.
Avoid the dusty and unstable-
temperature environment
In a very cold environment
When you want to discharge urine
Using the wet clothing to remove the dirt
Avoid washing the cuff
1110
ABOUT BLOOD PRESSURE
What are systolic pressure and diastolic
pressure?
When ventricles contract and pump blood
out of the heart, blood pressure reaches its
maximum value, the highest pressure in the
cycle is known as systolic pressure. When
the heart relaxes between heartbeats, the
lowest blood pressure is diastolic pressure.
Systolic
blood discharging
artery
press
Diastolic
blood entering
vein
relax
What is the standard blood pressure
classification?
The chart on the right is the standard
blood pressure classification published
by American Heart Association (AHA).
AHA Home Guideline for
Upper Limit of Normal BP
SYS 135 mm Hg
DIA 85 mm Hg
CAUTION
Only a physician can tell your normal BP range. Please contact a physician if your
measuring result falls out of the range. Kindly note that only a physician could tell whether
your blood pressure value has reached a dangerous point.
Irregular Heartbeat Detector
This Blood Pressure Monitor is equipped with an intelligent function of Irregular Heartbeat
(IHB) Detector. During each measurement, this equipment records the heartbeat intervals and
works out the standard deviation. If the calculated value is larger than or equal to 15, this
equipment will light up the IHB symbol on the screen when displaying the measuring result.
CAUTION
The appearance of the IHB icon indicates that a pulse irregularity consistent with an irregular
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.
12
This chart reflects blood pressure categories defined by American Heart Association.
Blood Pressure Category
Normal
Prehypertension
High Blood Pressure
(Hypertension) Stage 1
High Blood Pressure
(Hypertension) Stage 2
Hypertensive Crisis
(Emergency care needed)
Systolic
mmHg (upper#)
less than 120
120-139
140-159
160 or higher
Higher than 180
and
or
or
or
or
Diastolic
mmHg (lower#)
less than 80
80-89
90-99
100 or higher
Higher than 110
Why does my blood
pressure fluctuate
throughout the day?
1. Individual blood pressure varies
every in one day, it also affected by the
way you tie your cuff and the your
measurement position, so please take
the measurement at the same condition.
2.The varies of the pressure is
greater if the person take medicine.
3.Waiting at least 3 minutes for
another measurement.
Why the blood pressure
I get from the hospital
is different from home?
The blood pressure is different even
during 24 hour because of the
weather,emotion, exercise etc,
specially the “white coat” in hospital
which makes the results are higher
than the ones at home.
If the result is the same
if measuring on the
right arm?
It is ok for both arms, but there
will be some different results for
different arm, so suggest you
measure the same arm every time.
ABOUT BLOOD PRESSURE
The attention need to pay
when you measure you blood
pressure at home:
If the cuff is tied properly.
If the cuff is too tight or too loose.
If the cuff is tied on the upper arm.
If you feel anxious pressured.
You had better take deep breath 2-3
times before beginning.
Advice:adjust yourself for 4-5
minutes until you calm down.
13
TROUBLESHOOTING
SPECIFICATIONS
This section includes a list of error messages and frequently
asked questions for problems you may encounter with your blood
pressure monitor. If the products not operating as you think it
should, check here before arranging for servicing.
PROBLEM SYMPTOM CHECK THIS REMEDY
Replace with new batteries
Insert the batteries
correctly
Insert the AC adaptor
tightly
Replace with new batteries
Check the database is
power on or not.
Or synchronize the data
operation.
Refasten the cuff and then
measure again.
Check if the newwork is
connected normally or not.
Activate or register the
device again.
Relax for a
moment and then
measure again.
Loosen the clothing on the
arm and then measure
again
Relax for a moment and
then measure again.
Retake the measurement.
If the problem persists,
contact the retailer or our
customer service
department for further
assistance.Refer to the
warranty for contact
information and return
instructions.
No power
Low
batteries
Error
massage
Display will not
light up.
Display is dim
or show
E 1 shows RF communication failed.
E 3 shows
E 8 shows
E 9 shows
E10 or E11
shows
E20 shows
E21 shows
Exxx,shows on
the display.
Batteries are exhausted.
Batteries are inserted
incorrectly.
AC adaptor is inserted
incorrectly.
Batteries are low.
The cuff is not secure.
Failure of activating or
synchronizing the network
The device is not
activated or registered.
The monitor detected
motion,talking or the
pluse is too poor
while measuring.
The measurement
process does not detect
the pulse signal.
The treatment of the
measurement failed.
A calibration error
occurred.
Power supply
Display mode
Measurement mode
Measurement range
Accuracy
Normal working condition
Storage & transportation
condition
Measurement perimeter
of the upper arm
Net Weight
External dimensions
Attachment
Mode of operation
Degree of protection
Protection against
ingress of water
Device Classification
Software Version
Battery powered mode:
6VDC 4*AA alkaline batteries
AC adaptor powered mode:
100-240V~, 50-60HZ,400mA
(Can be supplied by AC adaptor model
UE08WCP-060100SPA only!)
Digital LCD V.A.78*92mm
Oscillographic testing mode
Rated cuff pressure:
0kpa - 40kpa (0mmHg~300mmHg)
Measurement pressure: 5.3kPa-30.7kPa
(40mmHg-230mmHg)
pulse value: (40-199) beat/minute
Pressure:
5℃-40℃within±0.4kpa(3mmHg)
pulse value:±5%
Temperature:5℃ to 40℃ Relative humidity ≤85%
Atmospheric pressure: 86kPa to 106kPa
Temperature:-20℃-60℃
Relative Humidity 10%-93%
Atmospheric Pressure: 50-106 kPa
About 22cm~32cm or 22cm~42cm
Approx.
Approx.120*160*69mm
4*AA alkaline batteries,user manual
Continuous operation
Type BF applied part
IP21
Battery powered mode: Internally powered ME Equipment
AC adaptor powered mode: CLASS II ME Euipment
V01
385g
(Excluding the dry cells)
1514
AUTHORIZED COMPONENTS
FCC STATEMENT
Authorized Components
１.Please use the TRANSTEK
authorized adaptor.
Adaptor
Type：UE08WCP-060100SPA
Input：100~240V，50~60Hz,400mA
Output：6V 1A
(Conforms to UL certificate)
2.Storage bag.
Contact Information
For more information about our products, please visit www.transtek.cn.you can get
customer service, usual problems and customer download, transtek will serve you
anytime.
Manufactured by:
Company:
Address:
GUANGDONG TRANSTEK MEDICAL ELECTRONICS CO., LTD
GUANGDONG TRANSTEK MEDICAL ELECTRONICS CO., LTD
Zone A, 5/F., Investment Building , No. 12, Huizhan East Rd., Torch
Development District, Zhongshan, Guangdong, 528437, China
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.
1716
COMPLIED STANDARDS LIST
EMC GUIDANCE
Complied Standards list
Risk management
Labeling
User manual
General
Requirements for
Safety
Electromagnetic
compatibility
Performance
requirements and
Clinical Investigation
Software life-cycle
processes
ISO/EN 14971:2012 Medical devices — Application of risk
management to medical devices
ISO/EN 15223-1:2012 Medical devices. Symbols to be
used with medical device labels, labelling and information to
be supplied. General requirements
EN 1041: 2008 Medical equipment manufacturers to
provide information
IEC 60601-1: 2005+A1：2012 Medical electrical
equipment - Part 1: General requirements for basic safety and
essential performance
IEC/EN 60601-1-2:2007 Medical electrical equipment Part 1-2: General requirements for basic safety and essential
performance - Collateral standard:Electromagnetic
compatibility - Requirements and tests
IEC 80601-2-30:2009 Medical electrical equipment- Part
2-30: Particular requirements for the basic safety and
essential performance of automated non-invasive
sphygmomanometers
ANSI/AAMI SP10:2002/A2: 2008 Manual, electronic, or
automated sphygmomanometers
IEC/EN 62304:2006+AC: 2008 Medical device software
- Software life cycle processes
EMC Guidance
1. MEDICAL ELECTRICAL EQUIPMENT needs special precautions
regarding EMC and needs to be installed and put into service according to
the EMC information provided in the ACCOMPANYING DOCUMENTS
2. Wireless communications equipment such as wireless home network
devices, mobile phones, cordless telephones and their base stations,
walkie-talkies can affect this equipment and should be kept at least a
distance d=3, 3m away from the equipment.
(Note: As indicated in Table 6 of IEC 60601-1-2:2007 for ME
EQUIPMENT, a typical cell phone with a maximum output power of 2 W
yields d=3, 3m at an IMMUNITY LEVEL of 3V/m)
18
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