Transtek Medical Electronics LS802-E01 BLOOD PRESSURE MONITOR User Manual LS 802
Guangdong Transtek Medical Electronics Co.,Ltd BLOOD PRESSURE MONITOR LS 802
User Manual
User Manual
Blood Pressure Monitor LS802-E
To use the monitor correctly and safely, please read the manual
thoroughly.
Thank you very much for selecting TRANSTEK Blood Pressure Monitor
LS802-E.
please keep well this manual in order to reference in future.
ZHONGSHAN TRANSTEKELECTRONICES CO.,LTD
Arm Type
Jin’an Road, Minzhong, Zhongshan,528441,Guangdong, China
Version:1.0
CATALOGUE INTRODUCTION
1
INTRODUCTION ............................................................... 1
Safety information
LCD display signal
Monitor components
BEFORE YOU START .......................................................... 4
The Choice of power supply
MEASUREMENT ............................................................... 5
Tie the cuff
Start a measurement
INFORMATION FOR USER...................................................... 7
Tips for measurement
Maintenance
ABOUT BLOOD PRESSURE..................................................... 9
What are systolic pressure and diastolic pressure?
What is the standard blood pressure classification?
Why does my blood pressure fluctuate throughout the day?
Why the blood pressure I get from the hospital is different from
home?
The result is different that you measuring on the different arm.
TROUBLESHOOTING ......................................................... 11
SPECIFICATIONS ............................................................. 12
AUTHORIZED COPMONENT ................................................... 13
COMPLIED EUROPEAN STANDARDS LIST...................................... 13
ELECTROMAGNETIC COMPATIBILITY DESCRIPTIONS .......................... 14
The below signs might be in the user manual, labeling or other component.
they are the requirement of standard and using.
Safety information
Caution:Consult accompanying
documents
CE Mark: conforms to
essential requirements of the
Medical Device Directive
93/42/EEC.
Manufacturer
Specifies
serial number
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 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 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.
This unit is not suitable for continuous monitoring during medical emergencies or operations.
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 wrist and press
the homologous button to stop inflation.
To avoid measurement errors, carefully read this manual before using the product.
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 AC 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 when using the AC adaptor.
The user must check that the equipment functions safely and see that it is in proper working
condition before being used.
The manufacturer does not require such preventive inspections by other persons.
CAUTION
Type B
applied part
Direct current
DISPOSAL: Do not dispose this
product as unsorted municipal
waste. Collection of such waste
separately for special treatment is
necessary.
Authorized Representative in
the European Community
EC REP
Thank you for selecting TRANSTEK arm type blood pressure Monitor (LS802-E).
The monitor features blood pressure measurement, pulse rate measurement and
auto-save the result. The design provides you with many 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:
93.5*79mm Bright LCD display with blue backlight
Maximum 60 records per user
Charging measuring technology
INTRODUCTION INTRODUCTION
2 3
CUFF
AIR HOSE
AIR CONNECTOR PLUG
LCD DISPLAY
DC POWER SOCKET
User A
Guest
User B
BATTERY COMPARTMENT
Monitor components
LCD display signal
List
1.Blood Pressure Monitor
(LS802-E)
4.User manual3. 4*AA alkaline batteries
2.Cuff (Type B applied part) (AC2232-01)
Component list of
pressure measuring system
1.Cuff
2.Micro Control Unit
3.Amplifier
4.Air pipe
5.Pump
6.Valve
User A User BGuest
SYMBOL DESCRIPTION
Systolic blood pressure High pressure result
Diastolic blood pressure Low pressure result
EXPLANATION
Pulse Pulse/minute
User A provide measurement for user A, and
then save the measure date automatically
Guest provide measurement for guests,
but not save the measurement data.
User B provide measurement for user B, and
then save the measure date automatically
Data storage to remind the users that the measurement
dates don’t upload to bridge in time
Wireless transmitter the blood monitor and Bridge in communication
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
Measurement Unit of the blood pressure
Unit
date (hour:minute) Currently time
Deflating CUFF air is exhausting of deflating
AC adaptor
BEFORE YOU START
5
4
The Choice of Battery
In order to get the best effect and protect you monitor,please use
the right battery and special power adapter.
１.Slide off the battery cover.
２.Install the batteries by matching
the correct polarity, as shown.
３.Replace the cover.
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.
The installment and replacement of battery
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.
CAUTION
Replace the batteries whenever the below happen
The shows
The display dims
The display does not light up
MEASUREMENT
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.
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 left
arm resting on a flat surface.
2~3cm
BEFORE YOU START
7
6
Tips for measurement
INFORMATION FOR USER
In a very cold enviroment
Immediate measurement
after tea, coffee, smoking
When talking or moving your fingers
When you want to discharge urine
It can cause incorrectness if the measurement are taken in the
following circumstances.
LCD display
Tips:
Inflating and measuring automatically.
Ｓｔａｒｔ ｔｈｅ Ｍｅａｒｓｕｒｅｍｅｎｔ
2.
In this manual, the measurement of user A as an example.
Press the (User A) to turn on the monitor and it will finish the whole
measurement automatically, and then save the measure date for User
A. The same to the (User B).
Adjust the zero automatically.
If the measure date don’t
upload to the bridge in time,
the icon will display.
Press the to power off , otherwise it will
turn off automatically within one minute.
Display and save the results will
transmit to the bridge through the
wireless.
Press the (Guests) to turn on the monitor and it will finish the whole
measurement automatically for Guests, but not save the measurement
data.
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 A and user B.
1. Press the to turn on the monitor.
User A
User A
User A
User A
Immediate measurement
after taking a bath
Immediate measurement
after dinner or drinking
9
8
ABOUT BLOOD 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.
What are systolic pressure and diastolic
pressure?
Below illustrates the blood pressure
classification mode by World Health
Organization (WHO) and International
Society of Hypertension(ISH) in 1999.
What is the standard blood pressure
classification?
Only a physician can tell you your normal blood pressure range
and the point at which you are at risk. Consult your physician to
obtain these values.
If the measurements taken with these products fall outside the
range, consulty.
Level
Blood
Pressure(mmHg)
SYS
DIA
<120
<80
120~129
80~84
130~139
85~89
140~159
90~99
160~179
100~109
>180
>110
Optimal Normal High-normal Mild Moderate Severe
CAUTION
INFORMATION
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
Using the wet clothing to remove the dirt
Avoid touching water,
clean it with a dry cloth in case.
Avoid the dusty and unstable-
temperature environment
Avoid washing the cuff
press
artery vein
blood discharging
Systolic
relax
blood entering
Diastolic
Instructions for correct replacement of interchangeable or detachable parts
specified by MANUFACTURER as replaceable by SERVICE PERSONNEL.
ABOUT BLOOD PRESSURE
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 4-5 minutes for
another measurement.
TROUBLESHOOTING
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.
Why my blood pressure
is varies even in one
day?
11
10
The result is different
that you measuring on
the different 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.
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.
PROBLEM SYMPTOM CHECK THIS REMEDY
No power
Low
batteries
Error
massage
Display is dim or
will not light up.
Batteries are exhausted. Replace with new batteries
Insert the batteries
correctly
Replace with new batteries
Batteries are inserted
incorrectly.
Show on
the display Batteries are low.
E 1 shows The cuff is not secure. Refasten the cuff and then
measure again.
E 2 shows The cuff is very tight Refasten the cuff and then
measure again.
E 3 shows The pressure of the
cuff is excess.
Relax for a moment
and then measure again.
The monitor detected
motion while measuring.
movement can affect the
measurement.Relax for a
moment and then
measure again.
Measure incorrectly. Relax for a moment and
then measure again.
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.
E 10 or
E 11 shows
E 20 or
E 21 shows
Eexx,shows on
the display.
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.
AUTHORIZED COPMONENT
13
The matched components
１.Please use the TRANSTEK
authorized adapter.
2.Storage bag.
12
SPECIFICATIONS
Complied European Standards list
Adapter
Type：UE08WCP-060100SPA
Input：100~240V，50~60Hz,400mA
Output：6V 1A
Power supply
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!)
Display moder Digital LCD V.A.93.5*79mm
Measurement mode Oscillographic testing mode
Measurement range Pressure: 0~40kpa(0~300mmHg)
pulse value:(40~199)times/minute
Accuracy
Pressure:
5℃~40℃within±0.5kpa(4mmHg)
pulse value:±5%
Normal working condition Temperature:5℃~40℃ Relative humidity ≤80%RH
Storage & transportation
condition
Temperature:-20℃~60℃
Relative humidity:10%~93%RH
Measurement perimeter
of the upper arm
About 22cm~42cm
Weight Approx.424g(Excluding the dry cells)
External dimensions
Attachment
Approx.138*110*60mm
4*AA alkaline batteries,user manual
Mode of operation Continuous operation
Degree of protection Type B applied part
Protection against
ingress of water
IPX-0
Risk management is the application of medical devices EN/ISO 14971:2007
Graphical symbols for labeling medical devices EN 980: 2008
Medical equipment manufacturers to provide information EN 1041: 2008
Medical electrical equipment Part 1-1: General Requirements
for Safety Collateral Standard: Safety requirements for medical
electrical systems
EN 60601-1:1990+A1+A2+A13
Non-invasive blood pressure Part 1: General requirements EN 1060-1:2001/A1:2002
Non-invasive blood pressure Part 3: Supplementary requirements for
electromechanical blood pressure measuring system EN 1060-3:1997/A1:2005
Automatic Blood Pressure Monitor overall system Interventional
accuracy of the testing process EN 1060-4: 2004
Medical electrical equipment Part 1-2: Basic safety and essential
performance of the general requirements Collateral Standard:
Electromagnetic compatibility requirements and tests
EN 60601-1-2:2001+A1：2006
WARNING: No modification of this equipment is allowed.
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
Authorized European Representative:
Manufactured by: ZHONGSHAN TRANSTEK ELECTRONICES CO.,LTD
Conpany: ZHONGSHAN TRANSTEK ELECTRONICES CO.,LTD
Address: JinanRoad,Jinbiao,Minzhong,Zhongshan,Guangdong,China
Conpany: MDSS - Medical Device Safety Service GmbH
Address: Schiffgraben 41,30175 Hannover, Germany
1514
Table 1 Guidance and manufacture’s declaration – electromagnetic emissions-
for all EQUIPMENT and SYSTEMS
Guidance and manufacture’s declaration – electromagnetic emission
Emission test Electromagnetic environment – guidance
RF emissions
CISPR 11
Group 1
Class B
Not applicable
Not applicable
Compliance
The LS802-E is intended for use in the electromagnetic environment specified
below. The customer of the user of the LS802-E should assure that it is used in
such and environment.
Harmonic emissions
IEC 61000-3-2
Voltage fluctuations/
flicker emissions IEC
61000-3-3
RF emission
CISPR 11
The LS802-E is intended for use in the electromagnetic environment specified
below. The customer or the user of LS802-E should assure that it is used in such an
environment.
Guidance and manufacture’s declaration – electromagnetic immunity
Immunity test
±6 kV contact
±8 kV air
±6 kV contact
±8 kV air
±2 kV for
power supply lines
±2kV for
power supply lines
±1 kV line(s)
to line(s)
±1 kV
differential mode
<5% UT
(>95% dip in UT)
for 0.5 cycle
40% UT
(60% dip in UT)
for 5 cycles
70% UT
(30% dip in UT)
for 25 cycles
<5% UT
(>95% dip in UT)
for 5 sec
<5% UT
(>95% dip in UT)
for 0.5 cycle
40% UT)
(60% dip in UT)
for 5 cycles
70% UT
(30% dip in UT)
for 25 cycles
<5% UT
(>95% dip in UT)
for 5 sec
3A/m
NOTE UT is the a.c. mains voltage prior to application of the test level.
Table 2 Guidance and manufacture’s declaration – electromagnetic immunity –
for all ME EQUIPMENT and ME SYSTEMS
IEC 60601 test level Compliance level
Electrostatic
discharge (ESD)
IEC 61000-4-2
Electromagnetic
environment - guidance
Floors should be wood,
concrete or ceramic tile. If
floor are covered with
synthetic material, the
relative humidity should be
at least 30%.
Mains power quality should
be that of a typical
commercial or hospital
environment.
Mains power quality should
be that of a typical
commercial or hospital
environment.
Mains power quality
should be that of a typical
commercial or hospital
environment. If the user of
the LS802-E requires
continued operation during
power mains interruptions,
it is recommended that the
LS802-E be powered from
an uninterruptible power
supply or a battery.
Power frequency magnetic
fields should be at levels
characteristic of a typical
location in a typical
commercial or hospital
environment.
3A/m
Power frequency
(50Hz) 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 IEC
61000-4-5
The
LS802-E
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 LS802-E 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.
1716
Table 4 Guidance and manufacture’s declaration – electromagnetic immunity –
for ME EQUIPMENT and ME SYSTEMS that are not LIFE-SUPPORTING
Guidance and manufacture’s declaration – electromagnetic immunity
Immunity test
3 Vrms
3 V/m
The LS802-E
is intended for use in the electromagnetic environment specified below.
The customer or the user should assure that it is used in such an environment.
Compliance
level
IEC 60601
test level
Conducted RF
IEC 61000-4-6
Radiated RF
IEC 61000-4-3
3 V/m 80 MHz
to 2.5 GHz
3 V
rms
150 kHz to
80 MHz
Electromagnetic environment -
guidance
Portable and mobile RF communications
equipment should be used no closer to
any part of the
YS-6100
, including
cables, than the recommended
separation distance calculated from the
equation applicable to the frequency of
the transmitter.
Portable and mobile RF communications
equipment should be used no closer to
any part of the including cables, than the
recommended separation distance
calculated from the equation applicable
to the frequency of the transmitter.
Recommended separation distance
d = 1.167
d = 1.167
80 MHz to 800 MHz
d
= 2.333
800 MHz to 2.5 GHz
where P is the maximum output power
rating of the transmitter in watts (W)
according to the transmitter
manufacturer and d is the recommended
separation distance in metres (m).
Field strengths from fixed RF
transmitters, as determined by an
electromagnetic site survey,
a
should be
less than the compliance level in each
frequency range.
Interference may occur in the vicinity of
equipment marked with the following
symbol:
NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic
propagation is affected by absorption and reflection from structures, objects and
people.
a Field strengths from fixed transmitters, such as base stations for radio
(cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM
radio broadcast and TV broadcast cannot be predicted theoretically with accuracy.
To assess the electromagnetic environment due to fixed RF transmitters, an
electromagnetic site survey should be considered. If the measured field strength in
the location in which the ELE007839V1 is used exceeds the applicable RF
compliance level above, the ELE007839V1 should be observed to verify normal
operation. If abnormal performance is observed, additional measures may be
necessary, such as reorienting or relocating the ELE007839V1.
b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
19
18
0,01
0.167 0.167 0.233
0,1
0.369 0.369 0.738
761.1 761.1 333.2
1
883.7 096.3 096.3
01
11.67 11.67 23.330
150 kHz to 80 MHz
d = 1.167
80 MHz to 800 MHz
d = 1.167
800 MHz to 2,5 GHz
d = 2.333
Table 6 Recommended separation distances between portable and mobile
RF communications equipment and the EQUIPMENT or SYSTEM –
for ME EQUIPMENT or ME SYSTEM that are not LIFE-SUPPORTING
Recommended separation distances between portable and mobile RF communica-
tions equipment and the ELE007839V1 Fitness Equipment.
The LS802-E
is intended for use in an electromagnetic environment in which radiated
RF disturbances are controlled. The customer or the user of the
LS802-E
can help
prevent electromagnetic interference by maintaining a minimum distance between
portable and mobile RF communications equipment (transmitters) and the
LS802-E
as recommended below, according to the maximum output power of the communica-
tions equipment.
Rated maximum output
power of transmitter
W
Separation distance according to frequency of transmitter
m
100
For transmitters rated at a maximum output power not listed above, the recommended
separation distance d in meters (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.
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.