User Manual Blood Pressure Monitor CGTEC TMB-1018

User Manual Blood Pressure Monitor CGTEC TMB-1018
User Manual
Blood Pressure Monitor CGTEC TMB-1018
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Thank you very much for selecting cgtec Blood Pressure Monitor TMB-1018.
To use the monitor correctly and safely, please read the manual thoroughly.
Please well keep this manual in order to reference in future.
CATALOGUE
INTRODUCTION ............................................................... 1
Safety information
LCD display signal
Monitor components
BEFORE YOU START .......................................................... 4
The Choice of power supply
Installing and replacing the batteries
Setting Date, time and measurement unit
MEASUREMENT ............................................................... 7
Tie the cuff
Start a measurement
THE OPERATION OF RECALLING RECORDS..................................... 9
Recall the records
Delete the records
INFORMATION FOR USER..................................................... 11
Tips for operation
Maintenances
ABOUT BLOOD PRESSURE.................................................... 13
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?
If the result is the same if measuring on the right arm?
TROUBLESHOOTING ......................................................... 15
SPECIFICATIONS ............................................................. 16
THE AUTHORIZED COPMONENT YOU NEED................. 17
CONTACT INFORMATION...................................................... 17
Complied European Standards list ...................................... 17
ELECTROMAGNETIC COMPATIBILITY DESCRIPTIONS................. 18
Thank you for selecting cgtec arm type blood pressure Monitor (TMB-1018).
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 TMB-1018 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.
INTRODUCTION
Features:
144*39mm 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 Caution: Consult accompanying
Type B applied part
CE Mark: conforms to essential requirements of the
Medical Device Directive 93/42/EEC.
DISPOSAL: Do not dispose this
product as unsorted municipal
waste. Collection of such waste
separately for special treatment is necessary.
Manufacturer
Direct current
Specifies
serial number
Authorized Representative in 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 arm and press
the 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
INTRODUCTION
LCD display signal
SYMBOL DESCRIPTION
Systolic blood pressure High pressure result
Diastolic blood pressure Low pressure result
EXPLANATION
Pulse Pulse/minute
Deflating CUFF air is exhausting of deflating
Time (hour:minute) Currently time
Memory If “M” shows, the displayed measurement
values is from the memory.
For instructions,refer to Page 9
mmHg Measurement Unit of the blood pressure
(1mmHg=0.133kPa)
kPa Measurement Unit of the blood pressure
(1kPa=7.5mmHg)
Low battery Batteries are low and need to be replaced
Shocking remainding Shocking will result in inaccurate
Average the average of blood pressure
Recalling the erecords will be showed
Arrhythmia Irregular heartbeat
Grade the grade of the blood pressure.
For instructions, refer to Page 13
Monitor components
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AIR HOSE
CUFF
DC POWER SOCKET
SET/UP BUTTON
START/OFF BUTTON
MEM/DOWN BUTTON
LCD DISPLAY
AIR CONNECTOR PLUG
BATTERY COMPARTMENT
DC POWER SOCKET
1.Blood Pressure Monitor (TMB-1018)
2.Cuff
3. 4*AAA alkaline batteries
4.User manual
Component list of pressure measuring system
1 Cuff
2 Micro Control Unit
3 Amplifier
4 Air pipe
5 Pump
6 Valve
BEFORE YOU START
The Choice of Battery
1.Battery powered mode: 6VDC 4*AAA alkaline batteries
2.AC adaptor powered mode:
100-240V~, 50-60HZ,400mA (Can be supplied by AC adaptor model UE08WCP-060100SPA
only!) Right picture is the hole in for power adapter.
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.
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.
Setting Date, time and measurement unit
It is important to set the clock before using your blood pressure
monitor, so that a time stamp can be assigned to each record that
is stored in the memory. (year :2000—2050,time:24 H)
1.
2.
3.
4.
5.
6.
7.
When the unit is off, hold pressing “SET” for 3 seconds to enter the mode for year setting.
Press the “MEM” to change the [YEAR].
When you get theright year, press“SET” to set down and turn to next step automatically.
Repeat the 2 and 3 to set the [MONTH] and [DAY].
Repeat the 2 and 3 to set the [HOUR] and [SECOND].
Repeat the 2 and 3 to set the set the [UNIT].
After the unit is set, the right picture will show, then it turn off automatically.
MEASUREMENT
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.
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.
Start the Measurement
1.Press the “START/STOP” to turn on the monitor, and it will finish the whole measurement
automatically.
LCD display
Adjust the zero automatically.
Inflating and measuring automatically.
Display and save the results automatically.
2. Press the “START/STOP” to power off, otherwise it will turn off automatically within 1
minute.
THE OPERATION OF RECALLING RECORDS
Recalling the records
1.Please press the “MEM” to show the average of the record.
Thesignof"AVG"willshowintherightcorner.
2.Press the “MEM” or “SET” to get the record you want.
The order of the record, date, time will display alternately.
It means the total of records is 8,
the current is the No 2. The corresponding date is 10th November.
The corresponding time is 10:38.
CAUTION
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.
THE OPERATION OF RECALLING RECORDS
Deleting a measurement record from memory
If you did not get the correct measurement, you can delete all
results by following below steps.
1. Hold pressing “MEM” for 3 seconds ,the flash display will show.
2.Press “SET” to confirm deleting and the monitor will turn off automatically.
3.If you don’t want to delete the records, press “START/STOP” to escape.
4. If there is no record the right display will show.
INFORMATION FOR USER
Tips for measurement
It can cause incorrectness if the measurement are taken in the
following circumstances.
Wait at least 1 hour after dinner or drinking
Immediate measurement after tea, coffee, smoking
Wait at least 20 minutes after taking a bath
When talking or moving your fingers
In a very cold environment
When you want to discharge urine
INFORMATION
Maintenance
In order to get the best performance, please follow the below instructions.
Put in a dry place and avoid the sunshine
Avoid touching water, clean it with a dry cloth in case.
Avoid the intense shaking and collision
Avoid the dusty and unstable temperature Environment
Using the wet clothing to remove the dirt
Avoid washing the cuff
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
Diastolic
blood entering vein
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.
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, consult.
Why my blood pressure is variable even in one day?
1. Individual blood pressure varies every in one day, it is also affected by the way you tie your cuff and the 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 hours 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 person, so suggest you measure the same arm every
time.
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 is not operating as you think it should, check
here before arranging for servicing.
PROBLEM
No power
Low batteries
Error massage
SYMPTOM
Display is dim or will not light up.
Show on the display
E 1 shows
E 2 shows
E 3 shows
E 10 or E 11 shows
E 20 or E 21 shows
Eexx,shows on the display.
CHECK THIS
Batteries are exhausted
Batteries are inserted incorrectly.
Batteries are low.
The cuff is not secure
The cuff is very tight
The pressure of the cuff is excess.
The monitor detected motion while measuring
Measure incorrectly
A calibration error occurred.
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.
SPECIFICATIONS
Power supply
Battery powered mode: 6VDC 4*AAA alkaline batteries AC adaptor powered mode: 100-240V~, 50-60HZ, 400mA
(Can be supplied by AC adaptor model UE08WCP-060100SPA only!)
Display mode
Digital LCD V.A.144*39mm
Measurement mode
Oscillographic testing mode
Measurement range
Pressure: 0~40kpa(0~300mmHg)
pulse value:(40~199)times/minute
Accuracy
Pressure:
within±0.4kpa(3mmHg)
pulse value:±5%
Normal working condition
Temperature:10 ~40
Relative humidity ≤80%
Storage & transportation condition
Temperature:-20 ~60
Relative humidity:10%~93%
Measurement perimeter of the upper arm
About 22cm~42cm
Weight
Approx.345g (Excluding the dry cells)
External dimensions
Approx.180*100*42mm
Attachment
4*AAA alkaline batteries user manual
Mode of operation
Continuous operation
Degree of protection
Type B applied part
Protection against ingress of water
IPX-0
MANUFACTURER
Manufactured by: CGTEC-EUROPE, LDA
Address: PRAÇA MADRE DEUS Nº 107, CANELAS, VILA NOVA DE GAIA, 4410-307 PORTUGAL
Contact: [email protected]
Complied European Standards list
Risk management is the application of medical device
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
Table 1 Guidance and manufacture’s declaration – electromagnetic emissions for all EQUIPMENT and SYSTEMS
Guidance and manufacture’s declaration – electromagnetic emission
The TMB-1018 is intended for use in the electromagnetic environment specified
below. The customer of the user of the TMB-1018 should assure that it is used in
such and environment.
Emission test
RF emissions
C ISPR 11
RF emission
CISPR 11
Harmonic emissions
IEC 61000-3-2
Voltage fluctuations/
flicker emissions IEC
61000-3-3
Compliance
Group 1
Class B
Not applicable
Not applicable
Electromagnetic environment – guidance
The TMB-1018 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 TMB-1018 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.
Table 2 Guidance and manufacture’s declaration – electromagnetic immunity –
for all ME EQUIPMENT and ME SYSTEMS
Guidance and manufacture’s declaration – electromagnetic immunity
The TMB-1018 is intended for use in the electromagnetic environment specified
below. The customer or the user of TMB-1018 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
IEC 60601 test level
±6 kV contact
±8 kV air
±2 kV for
power supply lines
±1 kV line(s)
to line(s)
<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
Compliance level
±6 kV contact
±8 kV air
±2kV for
power supply lines
±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
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 TMB-1018 requires
continued operation during
power mains interruptions,
it is recommended that the
TMB-1018 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.
NOTE UT is the ac. mains voltage prior to application of the test level.
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 TMB-1018 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
Conducted RF
IEC 61000-4-6
Radiated RF
IEC 61000-4-3
IEC 60601 test level
3 Vrms
150 kHz to
80 MHz
3 V/m 80 MHz
to 2.5 GHz
Compliance level
3 Vrms
3 V/m
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 meters (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.
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 communications equipment and the ELE007839V1 Fitness Equipment.
The TMB-1018 is intended for use in an electromagnetic environment in which
radiated RF disturbances are controlled. The customer or the user of the TMB-1018
can help prevent electromagnetic interference by maintaining a minimum distance
between portable and mobile RF communications equipment (transmitters) and the
TMB-1018 as recommended below, according to the maximum output power of the
communications equipment.
Rated maximum output
power of transmitter
W
0,01
0,1
1
10
100
Separation distance according to frequency of transmitter
M
150 kHz to 80 MHz
d = 1.167
0.167
0.369
1.167
3.690
11.67
80 MHz to 800 MHz
d = 1.167
0.167
0.369
1.167
3.690
11.67
800 MHz to 2,5 GHz
d = 2.333
0.233
0.738
2.333
7.388
23.330
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.
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