Transtek Medical Electronics LS802 E01 User Manual

User Manual
Version:1.0
Blood Pressure Monitor
LS802-E
Arm Type
Jin’an Road, Minzhong, Zhongshan,528441,Guangdong, 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 INTRODUCTION
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
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
Safety information
The below signs might be in the user manual, labeling or other component.
they are the requirement of standard and using.
Caution:Consult accompanying documents
CE Mark: conforms to essential requirements of the Medical Device Directive 93/42/EEC.
Manufacturer
Specifies
serial number
DISPOSAL: Do not dispose this product as unsorted municipal waste. Collection of such waste separately for special treatment is necessary.
Authorized Representative in
EC REP
the European Community
CAUTION
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.
Type B
applied part
Direct current
1
INTRODUCTION INTRODUCTION
LCD display signal
User A User BGuest
SYMBOL DESCRIPTION
Systolic blood pressure High pressure result
Diastolic blood pressure Low pressure result
Pulse Pulse/minute
User A provide measurement for user A, and
Guest
User B
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 CUFF air is exhausting of deflating
EXPLANATION
then save the measure date automatically
provide measurement for guests, but not save the measurement data.
provide measurement for user B, and then save the measure date automatically
to remind the users that the measurement dates don’t upload to bridge in time
the blood monitor and Bridge in communication
Measurement Unit of the blood pressure
Monitor components
CUFF
AIR HOSE
AIR CONNECTOR PLUG
User B
Guest
User A
Component list of
pressure measuring system
1.Cuff
2.Micro Control Unit
3.Amplifier
4.Air pipe
5.Pump
6.Valve
List
1.Blood Pressure Monitor
(LS802-E)
2.Cuff (Type B applied part) (AC2232-01)
4.User manual3. 4*AA alkaline batteries
LCD DISPLAY
DC POWER SOCKET
BATTERY COMPARTMENT
2 3
BEFORE YOU START
MEASUREMENT
The Choice of Battery
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.
AC adaptor
CAUTION
In order to get the best effect and protect you monitor,please use
the right battery and special power adapter.
The installment and replacement of battery
1.Slide off the battery cover.
2.Install the batteries by matching
the correct polarity, as shown.
.Replace the cover.
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
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.
4
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.
5
BEFORE YOU START
Start the Mearsurement
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). Press the (Guests) to turn on the monitor and it will finish the whole measurement automatically for Guests, but not save the measurement data.
In this manual, the measurement of user A as an example.
1. Press the to turn on the monitor.
INFORMATION FOR USER
Tips for measurement
It can cause incorrectness if the measurement are taken in the
following circumstances.
LCD display
User A
Inflating and measuring automatically.
User A
2.
Press the to power off , otherwise it will turn off automatically 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 A and user B.
Adjust the zero automatically. If the measure date don’t upload to the bridge in time, the icon will display.
User A
Display and save the results will transmit to the bridge through the wireless.
User A
6
Immediate measurement
after dinner or drinking
Immediate measurement
after taking a bath
In a very cold enviroment
Immediate measurement
after tea, coffee, smoking
When talking or moving your fingers
When you want to discharge urine
7
INFORMATION
ABOUT BLOOD PRESSURE
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
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
What is the standard blood pressure
classification?
Below illustrates the blood pressure classification mode by World Health Organization (WHO) and International Society of Hypertension(ISH) in 1999.
Level
Blood Pressure(mmHg)
SYS
DIA
Optimal Normal High-normal Mild Moderate Severe
<120
<80
120~129
80~84
130~139
85~89
140~159
90~99
160~179
100~109
Diastolic
blood entering
vein
relax
>180
>110
Using the wet clothing to remove the dirt
Instructions for correct replacement of interchangeable or detachable parts
specified by MANUFACTURER as replaceable by SERVICE PERSONNEL.
Avoid washing the cuff
8
CAUTION
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.
9
ABOUT BLOOD PRESSURE
TROUBLESHOOTING
Why my blood pressure is varies even in one 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 4-5 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.
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.
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.
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
Replace with new batteries
Refasten the cuff and then measure again.
Refasten the cuff and then measure again.
Relax for a moment and then measure again.
movement can affect the measurement.Relax for a moment 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 is dim or
will not light up.
Show on the display
E 1 shows
E 2 shows The cuff is very tight
E 3 shows
E 10 or E 11 shows
E 20 or E 21 shows
Eexx,shows on the display.
Batteries are exhausted.
Batteries are inserted incorrectly.
Batteries are low.
The cuff is not secure.
The pressure of the cuff is excess.
The monitor detected motion while measuring.
Measure incorrectly.
A calibration error occurred.
10
11
SPECIFICATIONS
AUTHORIZED COPMONENT
Battery powered mode:
6VDC 4*AA alkaline batteries
AC adaptor powered mode:
Power supply
100-240V~, 50-60HZ,400mA
(Can be supplied by AC adaptor model
UE08WCP-060100SPA only!)
Display moder
Measurement mode
Measurement range
Digital LCD V.A.93.5*79mm
Oscillographic testing mode
Pressure: 0~40kpa(0~300mmHg)
pulse value:(40~199)times/minute
Pressure:
Accuracy
Normal working condition
Storage & transportation
condition
Measurement perimeter
5~40within±0.5kpa(4mmHg)
pulse value:±5%
Temperature:5~40 Relative humidity ≤80%RH
Temperature:-20~60
Relative humidity:10%~93%RH
About 22cm~42cm
of the upper arm
Weight
External dimensions
Attachment
Mode of operation
Degree of protection
Protection against
Approx.424g(Excluding the dry cells)
Approx.138*110*60mm
4*AA alkaline batteries,user manual
Continuous operation
Type B applied part
IPX-0
ingress of water
WARNING: No modification of this equipment is allowed.
12
The matched components
1.Please use the TRANSTEK
authorized adapter.
Adapter Type:UE08WCP-060100SPA Input:100~240V50~60Hz,400mA Output:6V 1A
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: Conpany: Address:
Authorized European Representative: Conpany:
Address:
ZHONGSHAN TRANSTEK ELECTRONICES CO.,LTD
ZHONGSHAN TRANSTEK ELECTRONICES CO.,LTD
JinanRoad,Jinbiao,Minzhong,Zhongshan,Guangdong,China
MDSS - Medical Device Safety Service GmbH
Schiffgraben 41,30175 Hannover, Germany
Complied European Standards list
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
Non-invasive blood pressure Part 1: General requirements
Non-invasive blood pressure Part 3: Supplementary requirements for
electromechanical blood pressure measuring system
Automatic Blood Pressure Monitor overall system Interventional
accuracy of the testing process
Medical electrical equipment Part 1-2: Basic safety and essential performance of the general requirements Collateral Standard:
Electromagnetic compatibility requirements and tests
EN 60601-1:1990+A1+A2+A13
EN 1060-1:2001/A1:2002
EN 1060-3:1997/A1:2005
EN 1060-4: 2004
EN 60601-1-2:2001+A12006
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Table 1 Guidance and manufacture’s declaration – electromagnetic emissions-
for all EQUIPMENT and SYSTEMS
Guidance and manufacture’s declaration – electromagnetic emission
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.
Emission test Electromagnetic environment – guidance
RF emissions CISPR 11
RF emission CISPR 11
Harmonic emissions IEC 61000-3-2
Voltage fluctuations/ flicker emissions IEC
Compliance
Group 1
Class B
Not applicable
Not applicable
The
LS802-E
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.
uses RF energy only for its
61000-3-3
Table 2 Guidance and manufacture’s declaration – electromagnetic immunity –
for all ME EQUIPMENT and ME SYSTEMS
Guidance and manufacture’s declaration – electromagnetic immunity
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.
Immunity test
Electrostatic discharge (ESD) IEC 61000-4-2
Electrical fast transient/burst IEC 61000-4-4
Surge IEC 61000-4-5
Voltage dips, short interruptions and voltage variations on power supply input lines IEC 61000-4-11
Power frequency (50Hz) magnetic field IEC 61000-4-8
NOTE UT is the a.c. mains voltage prior to application of the test level.
IEC 60601 test level Compliance level
±6 kV contact ±8 kV air
±2 kV for power supply lines
±1 kV line(s) to line(s)
<5% U
T
(>95% dip in UT) for 0.5 cycle
40% U
T
(60% dip in UT) for 5 cycles
70% U
T
(30% dip in UT) for 25 cycles
<5% U
T
(>95% dip in UT) for 5 sec
3A/m
±6 kV contact ±8 kV air
±2kV for power supply lines
±1 kV differential mode
<5% U
T
(>95% dip in UT) for 0.5 cycle
40% UT) (60% dip in UT) for 5 cycles
70% U
T
(30% dip in UT) for 25 cycles
<5% U
T
(>95% dip in UT) for 5 sec
3A/m
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 batter
Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment.
y.
1514
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
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.
Immunity test
IEC 60601 test level
Compliance level
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
Conducted RF IEC 61000-4-6
3 V
rms
150 kHz to 80 MHz
3 Vrms
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
Radiated RF IEC 61000-4-3
3 V/m 80 MHz to 2.5 GHz
3 V/m
d = 1.167
d
= 2.333
80 MHz to 800 MHz 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).
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 theoreticall
y 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.
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:
1716
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-
The LS802-E RF disturbances are controlled. The prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the as recommended below, according to the maximum output power of the communica­tions equipment.
Rated maximum output
power of transmitter
0,01
0,1
1
01
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 r
tions equipment and the ELE007839V1 Fitness Equipment.
is intended for use in an electromagnetic environment in which radiated
Separation distance according to frequency of transmitter
W
150 kHz to 80 MHz
d = 1.167
customer or the user of the
m
80 MHz to 800 MHz
d = 1.167
0.167 0.167 0.233
0.369 0.369 0.738
761.1 761.1 333.2
11.67 11.67 23.330
eflection from structures, objects and people.
LS802-E
800 MHz to 2,5 GHz
can help
LS802-E
d = 2.333
883.7 096.3 096.3
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.
18
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