Tabela 4 Wytyczne i deklaracja wytwórcy – odporność
elektromagnetyczna – dla MEDYCZNEGO WYPOSAŻENIA
ELEKTRYCZNEGO i MEDYCZNYCH SYSTEMÓW ELEKTRYCZNYCH
nie wykorzystywanych do PODTRZYMYWANIA FUNKCJI
ŻYCIOWYCH
rok zał. 1949
B. WÓJCIK s-ka jawna
0 0 - 8 0 1 W arsz aw a, u l. C hm ielna 9 8
B I U R O H A N D L O W E : tel. : (2 2 ) 6 5 4 6 4 9 2
S K L E P F I R M O W Y : tel. : (2 2 ) 6 5 4 6 4 9 3
S E R W I S : tel. : ( 2 2 ) 8 5 3 3 0 1 0 , f ak s: ( 2 2 ) 6 2 0 7 7 4 2
w w w . techm ed. pl e- m ail: techm ed@ techm ed. pl
P oland, E u rope
Established in 1949
LEADER OF THE
DECADE
USER MANUAL
DIGITAL BLOOD PRESSURE AND HEART RATE MONITOR
MODEL: TMA-20 SMART
INTRODUCTION
1. General Description
Thank you for selecting TECH-MED arm type blood pressure
monitor (TMA-20 SMART). The monitor features blood pressure
measurement, pulse rate measurement and the result storage. The
design provides you with two years of reliable service.
Readings taken by the TMA-20 SMART are equivalent to those
obtained by a trained observer using the cuff and stethoscope auscultation method.
This manual contains important safety and care information, and
provides step by step instructions for using the product.
Read the manual thoroughly before using the product.
Features:
• 65mm×50mm Blue LCD with white backlight ]
• Maximum 60 records
• 3rd technonoly: Measuring during inflation
2. Indications for Use
The TECH-MED Blood Pressure Monitor is digital monitors inten-
ded for use in measuring blood pressure and heartbeat rate with
arm circumference ranging from 22 cm to 32 cm ( about 8¾˝-12½˝)
or 22cm to 42cm(about 8¾˝-16½˝). It is intended for adult indoor
use only.
3. Measurement Principle
This product uses the Oscillometric Measuring method to detect
blood pressure. Before every measurement, the unit establishes
a “zero pressure” equivalent to the air pressure. Then it starts inflating the arm cuff, meanwhile, the unit detects pressure oscillations
generated by beat-to-beat pulsatile, which is used to determine
the systolic and diastolic pressure, and also pulse rate.
– 2 –– 3 –
The device also compares the longest and the shortest time in-
tervals of detected pulse waves to mean time interval then calculates standard deviation. The device will display a warning signal
with the reading to indicate the detection of irregular heartbeat
when the difference of the time intervals is over 25%.
4. Safety Information
The signs below 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”
Symbol for “TYPE BF APPLIED PARTS”
Symbol for “COMPLIES WITH MDD 93/42/EEC REQUIRE-
0197
MENTS”
Symbol for “MANUFACTURER”
Symbol for “SERIAL NUMBER”
Symbol for “ENVIRONMENT PROTECTION - Electrical waste
products should not be disposed of with household waste.
Please recycle where facilities exist. Check with your local
authority or retailer for recycling advice”
Symbol for “DIRECT CURRENT”
Symbol for “Authorised Representative in the European Community
Symbol for “MANUFACTURE DATE”
Symbol for “Recycle”
Caution: These notes must be observed to prevent any
damage to the device.
The Green Dot is the license symbol of a European network of
industry-funded systems for recycling the packaging materials of
consumer goods.
CAUTION
* This device is intended for adult use in homes only.
* The device is not suitable for use on neonatal patients, pregnant
women,patients with implanted, electronical devices, patients
with pre-eclampsia, premature ventricular beats, atrial fibrillation,
peripheral, arterial disease and patients undergoing intravascular
therapy or arterio-venous shunt or people who received a mastectomy. Please consult your doctor prior to using the unit if you
suffer from illnesses.
* The device is not suitable for measuring the blood pressure of
children. Ask your doctor before using it on older children.
– 4 –– 5 –
* The device is not intended for patient transport outside a heal-
thcare facility.
* The device is not intended for public use.
* This device is intended for no-invasive measuring and monitoring
of arterial blood pressure.It is not intended for use on extremities
other than the arm or for functions other than obtaining a blood
pressure measurement.
* Do not confuse self-monitoring with self-diagnosis. This unit al-
lows you to monitor your blood pressure.Do not begin or end me-
dical treatment without asking a physician for treatment advice.
* If you are taking medication,consult your physician to determine
the most appropriate time to measure your blood pressure. Never
change a prescribed medication without consulting your physi-
cian.
CAUTION
* Do not take any therapeutic measures on the basis of a self me-
asurement. Never alter the dose of a medicine prescribed by
a doctor. Consult your doctor if you have any question about your
blood pressure.
* When the device was used to measure patients who have com-
mon arrhythmias such as atrial or ventricular premature beats or
atrial fibrillation, the best result may occur with deviation. Please
consult your physician about the result.
* Don’t kink the connection tube during use, otherwise, the cuff
pressure may continuously increase which can prevent blood
flow and result in harmful injury to the PATIENT.
* When using this device, please pay attention to the following si-
tuation which may interrupt blood flow and influence blood cir-
culation of the patient, thus cause harmful injury to the patient:
connection tubing kinking too frequent and consecutive multiple
measurements; the application of the cuff and its pressurization
on any arm where intravascular access or therapy, or an arterio-
-venous (A-V) shunt, is present; inflating the cuff on the side of
a mastectomy.
* Warning: Do not apply the cuff over a wound;otherwise it can
cause further injury.
* Do not inflate the cuff on the same limb which other monitoring
ME equipment is applied around simultaneously, because this co-
uld cause temporary loss of function of those simultaneously-used
monitoring ME equipment.
* On the rare occasion of a fault causing the cuff to remain fully
inflated during measurement, open the cuff immediately. Prolon-
ged high pressure (cuff pressure >300mmHg or constant pressure
>15mmHg for more than 3 minutes) applied to the arm may lead
to an ecchymosis.
* Please check that operation of the device does not result in pro-
longed impairment of patient blood circulation.
* When measurement, please avoid compression or restriction of
the connection tubing.
* The device cannot be used with HF surgical equipment at the
same time.
* The ACCOMPANYING DOCUMENT shall disclose that the
SPHYGMOMANOMETER was clinically investigated according
to the requirements of ISO 81060-2:2013.
* To verify the calibration of the AUTOMATED SPHYGMOMANO-
METER, please contact the manufacturer.
* This device is contraindicated for any female who may be suspec-
ted of, or is pregnant. Besides providing inaccurate readings, the
effects of this device on the fetus are unknown.
* Too frequent and consecutive measurements could cause distur-
bances in blood circulation and injuries.
* This unit is not suitable for continuous monitoring during medi-
cal emergencies or operations.Otherwise, the patient’s arm and
fingers will become anaesthetic, swollen and even purple due to
a lack of blood.
* When not in use, store the device with the adapter in a dry room
and protect it against extreme moisture, heat, lint, dust and direct
sunlight. Never place any heavy objects on the storage case.
* This device may be used only for the purpose described in this bo-
oklet. The manufacturer cannot be held liable for damage caused
by incorrect application.
– 6 –– 7 –
* This device comprises sensitive components and must be treated
with caution. Observe the storage and operating conditions de-
scribed in this booklet.
* The equipment is not AP/APG equipment and not suitable for use
in the presence of a flammable anesthetic mixture with air of with
oxygen or nitrous oxide.
* Warning: No servicing/maintenance while the ME equipment is
in use.
* The patient is an intended operator.
* The patient can measure data and change battery under normal
circumstances and maintain the device and its accessories accor-
ding to the user manual.
* To avoid measurement errors, please avoid the condition of strong
electromagnetic field radiated interference signal or electrical fast
transient/burst signal.
* The blood pressure monitor, its adaptor, and the cuff are suitable
for use within the patient environment. If you are allergic to poly-
ester, nylon or plastic, please don’t use this device.
* During use, the patient will be in contact with the cuff. The ma-
terials of the cuff have been tested and found to comply with
requirements of ISO 10993-5:2009 and ISO 10993-10:2010.
It will not cause any potential sensization or irritation reaction.
* Adaptor is specified as a part of ME EQUIPMENT.
CAUTION
* If you experience discomfort during a measurement, such as pain
in the arm or other complaints, press the START/STOP button to
release the air immediately from the cuff. Loosen the cuff and
remove it from your arm.
* If the cuff pressure reaches 40 kPa (300 mmHg), the unit will au-
tomatically deflate. Should the cuff not deflate when pressures
reaches 40 kPa (300 mmHg), detach the cuff from the arm and
press the START/STOP button to stop inflation.
* Before use, make sure the device functions safely and is in proper
working condition. Check the device, do not use the device if it is
damaged in any way. The continuous use of a damaged unit may
cause injury, improper results, or serious danger.
* Do not wash the cuff in a washing machine or dishwasher!
* The service life of the cuff may vary by the frequency of wa-
shing, skin condition, and storage state. The typical service life is
10000 times.
* It is recommended that the performance should be checked every
2 years and after maintenance and repair, by retesting at least the
requirements in limits of the error of the cuff pressure indication
and air leakage (testing at least at 50mmHg and 200mmHg).
* Please dispose of ACCESSORIES, detachable parts, and the ME
EQUIPMENT according to the local guidelines.
* Manufacturer will make available on request circuit diagrams,
component part lists, descriptions, calibration instructions,etc., to
assist to service personnel in parts repair.
* The plug/adapter plug pins insulates the device from the main
supply. Do not position the device in a position where it is diffi-
cult to disconnect from the supply mains to safely terminate ope-
ration of ME equipment.
* The operator shall not touch output of batteries /adapter and the
patient simultaneously.
* Cleaning :Dust environment may affect the performance of the
unit. Please use the soft cloth to clean the whole unit before and
after use. Don’t use any abrasive or volatile cleaners.
* The device doesn’t need to be calibrated within two years of relia-
ble service.
* If you have any problems with this device, such as setting up,
maintaining or using, please contact the SERVICE PERSONNEL
of TECH-MED. Don’t open or repair the device by yourself in the
event of malfunctions. The device must only be serviced, repaired
and opened by individuals at authorized sales/service centers.
* Please report to TECH-MED if any unexpected operation or events
occur.
* Keep the unit out of reach of infants, young children or pets to
avoid inhalation or swallowing of small parts. It is dangerous or
even fatal.
* Be careful to strangulation due to cables and hoses, particularly
due to excessive length.
– 8 –– 9 –
* At least 30 min required for ME equipment to warm from the mini-
mum storage temperature between uses until it is ready for inten-
ded use. At least 30 min required for ME equipment to cool from
the maximum storage temperature between uses until it is ready
for intended use.
* This equipment needs to be installed and put into service in ac-
cordance with the information provided in the ACCOMPANYING
DOCUMENTS;
* Wireless communications equipment such as wireless home ne-
twork devices, mobile phones, cordless telephones and their base
stations, walkie-talkies can affect this equipment and should be
kept at least a distance d away from the equipment. The distan-
ce d is caculated by the MANUFACTURER from the 80 MHz to
5.8 GHz column of Table 4 and Table 9 of IEC 60601-1-2:2014,
as appropriate.
* Please use ACCESSORIES and detachable partes specified/ autho-
rised by MANUFACTURE. Otherwise, it may cause damage to the
unit or danger to the user/patients.
* There is no luer lock connectors are used in the construction of
tubing, there is a possibility that they might be inadvertently con-
nected to intravascular fluid systems, allowing air to be pumped
into a blood vessel.
* Please use the device under the environment which was provided
in the user manual. Otherwise, the performance and lifetime of
the device will be impacted and reduced.
INTRODUCTION
1. LCD display signal
mmHg
mmHg
/min
SYMBOLDESCRIPTIONEXPLANATION
SYSSystolic pressureHigh blood pressure
DIADiastolic pressure Low blood pressure
PUL/min.Pulse displayPulse in beats per minute
mmHgmmHg
Blood pressure
level indicator
Low batteryBatteries are low and need to be replaced
Measurement Unit of the blood pressure
(1mmHg=0.133kPa)
Indicate the blood pressure level
Irregular hear-
tbeat
Blood pressure monitor is detecting an
irregular heartbeat during measurement.
Current TimeYear/Month/Day, Hour : Minute
Heartbeat
Blood pressure monitor is detecting
a heartbeat during measurement.
AVGAverage valueThe average value of blood pressure
In order to get the best effect and protect your monitor,please use
the right battery and special power adaptor which complies with
CE safety standard.
2. Installing and Replacing the Batteries
• Open the battery cover.
• Install the batteries by matching the correct polarity, as
shown.
• Replace the battery cover.
The typical service life of the new and unused batteries is
120 measurements for the operation time is 60s.
Replace the batteries whenever the below happen
• The shows
• The display is dim
• The display does not light up.
– 12 –– 13 –
CAUTION
• Do not use new and used batteries together.
• Do not use different types of batteries together.
• Do not dispose the batteries in fire. Batteries may explode or leak.
Remove batteries if the device is not likely to be used for some time.
Worn batteries are harmful to the environment. Do not
dispose with daily garbage. Remove the old batteries from
the device following your local recycling guidelines.
3. Setting Date and Time.
Setting Date and Time.
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. (The setting range of the year :2017—
2057; Time format:24H)
1. When the monitor is off, hold pressing „START/STOP”
for 3 seconds to enter the mode for year setting.
2. Press „PAMIĘĆ” button to change the [YEAR]. Each press will increase the numeral by one in a cycling manner.
3. Press „START/STOP” button to confirm [YEAR]. Then the monitor
diverts to [MONTH] and [DAY] setting.
– 14 –– 15 –
4. Repeat steps 2 and 3 to set the [MONTH] and [DAY].
5. Repeat steps 2 and 3 to set the [HOUR] and [MINUTE].
6. After hour and minute is set,the LCD will display “doNE” first,
then display all the settings you have done and then turn off.
MEASUREMENT
2 ~ 3 cm
1. Tie the cuff
1. Remove all jewelry, such as watches and bracelets from your
left arm.
Note: If your doctor has diagnosed you with poor circula-
tion in your left arm, use your right arm.
2. Roll or push up your sleeve to expose the skin.
Make sure your sleeve is not too tight.
– 16 –– 17 –
3. Hold your arm with your palm facing up and tie the cuff on your
upper arm, then position the tube off-center toward the inner side
of arm in line with the little finger. Or position the artery mark
over the main artery (on the inside of your arm).
Note: Locate the main artery by pressing with 2 fingers approxi-
mately 2 cm above the bend of your elbow on the inside of your
left arm. Identify where the pulse can be felt the strongest. This is
your main artery.
4. The cuff should be snug but not too tight. You should be able to
insert one finger between the cuff and your arm.
5. Sit comfortably with your tested arm resting on a flat surface. Place your elbow on a table so that the cuff is at the same level as
your heart. Turn your palm upwards. Sit upright in a chair, and
take 5-6 deep breaths.
6. Helpful tips for Patients, especially for Patients with Hypertension:
• Rest for 5 minutes before first measuring.
• Wait at least 3 minutes between measurements.
• This allows your blood circulation to recover.
• Take the measurement in a silent room.
• The patient must relax as much as possible and do not move
and talk during the measurement procedure.
• The cuff should maintain at the same level as the right atrium
of the heart.
• Please sit comfortably. Do not cross your legs and keep your
feet flat on the ground.
• Keep your back against the backrest of the chair.
• 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. When the monitor is off, press „START/STOP” ” button to turn on
the monitor, and it will finish the whole measurement. (Take user
1 for example.)
LCD display Adjust the zero.
Inflating Display and save
and measuring. the measurement result.
– 18 –– 19 –
2. Press the „START/STOP” to power off, otherwise it will turn off
within 1 minute.
DATA MANAGEMENT
1. Recall the Records
1. When the monitor is off, please press „PAMIĘĆ” button to show
the average value of the latest three records.If the records are
less than 3 groups, it will display the latest record instead.
2. Press the „PAMIĘĆ” to get the record you want.
The date and time of the record will be shown alternately.
The current No. is No 1. Five records in total.
The corresponding date is January 1st 2017.
The corresponding time is A.M. 6:00.
2. Delete the Records
If you did not get the correct measurement, you can delete all
results for the selected user by following steps below .
1. Hold pressing „PAMIĘĆ” button
for 3 seconds when the monitor
is in the memory recall mode ,the
flash display “dEL ALL” will show.
– 20 –– 21 –
2. Hold Press „START/STOP” button
to confirm deleting and the monitor will turn off.
Note: To exit out of delete
mode without deleting any records, press „START/STOP” button.
3. If there is no record, press „PA-
MIĘĆ” button, the right display
will show.
INFORMATION FOR USER
1. Tips for Measurement
Measurements may be inaccurate if taken in the following circu-
mstances.
Within 1 hour after dinner or
drinking
Immediate measurement
after tea, coffee, smoking
Within 20 minutes after taking
a bath
When talking or moving
your fingers
In a very cold environmentWhen you want to dischar-
ge urine
– 22 –– 23 –
MAINTENANCE
In order to get the best performance, please follow the instructions
below.
Put in a dry place and avoid the
sunshine
Avoid intense shaking and
collisions
Avoid touching water,
clean it with a dry cloth
in case.
Avoid dusty and unstable
temperature environment
Using wet cloths to remove dirtDo not attempt to clean the
reusable cuff with water
and never immerse the cuff
in water.
ABOUT BLOOD PRESSURE
1. What are systolic pressure and diastolic pressure?
When ventricles contract and pump blood out of the heart, the
blood pressure reaches its maximum value in the cycle, which
is called systolic pressure. When the ventricles relax, the blood
pressure reaches its minimum value in the cycle, which is called
diastolic pressure.
Systolic
blood discharging
artery
press
Diastolic
blood entering
vein
relax
2. What is the standard blood pressure classification?
The blood pressure classification published by World Health Or-
ganization (WHO) and International Society of Hypertension (ISH)
in 1999 is as follows:
– 24 –– 25 –
Systolic
pressure
(mmHg)
High blood pressure
Moderate hypertension
Slight hypertension
High pressure, normal
Normal pressure
Optimal
pressure
Diastolic
pressure
(mmHg)
CAUTION
Only a physician can tell your normal BP range. Please contact a physician if your measuring result falls out of the range. Please note that
only a physician can tell whether your blood pressure value has reached a dangerous point.
Blood
Pressure
SYS<120120-129130-139140-159160-179≥180
DIA<8080-8485-8990-99100-109≥110
OptimalNormal
High-
normal
MildModerateSevere
3. Irregular Heartbeat Detector
An irregular heartbeat is detected when a heartbeat rhythm va-
ries while the unit is measuring the systolic and diastolic blood
pressure.During each measurement, the monitor records all the
pulse intervals and calculate the average ; if there are two or more
pulse intervals ,the difference between each interval and the average is more than the average value of ±25% , or there are four
or more pulse intervals ,the difference between each interval and
the average is more than the average value of ±15%,the irregular
heartbeat symbol appears on the display when the measurement
results are appear.
CAUTION
The appearance of the IHB icon indicates that a pulse irregularity
consistent with an irregular heart-beat 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.
4. Why does my blood pressure fluctuate throughout the day?
1. Individual blood pressure varies multiple times everyday. It
is also affected by the way you tie your cuff and your measurement position, so please take the measurement under the
same conditions.
2. If the person takes medicine, the pressure will vary more.
3. Wait at least 3 minutes for another measurement.
What you need to pay attention to when you measure your blood
pressure at home:
If the cuff is tied properly.
If the cuff is too tight or too loose. If the cuff is tied on the upper
arm. If you feel anxious. Taking 2-3 deep breaths before beginning will be better for measuring.
Advice: Relax yourself for 4-5 minutes until you calm down.
5. Why do I get a different blood pressure at home compared to the
hospital?
The blood pressure is different even throughout the day due to we-
ather, emotion, exercise etc, Also, there is the “white coat” effect,
which means blood pressure usually increases in clinical settings.
– 26 –– 27 –
6. Is the result the same if measuring on the right arm?
It is ok for both arms, but there will be some different results for
different people. We suggest you measure the same arm every
time.
TROUBLE SHOOTING
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 SYMPTOMCHECK THISREMEDY
No power
Low
batteries
Display will
not light up.
Display is
dim or show
Batteries are
exhausted.
Batteries are
inserted incorrectly.
Batteries are low. Replace with new batteries
Replace with new batteries
Insert the batteries correctly
Error
message
Warning
message
E 01 shows
E 02 shows
E 03 shows
E 04 shows
EExx,shows
on the
display.
„out” shows
The cuff is too
tight or too
loose.
The monitor
detected motion
while measuring.
The measurement process
does not detect
the pulse signal.
The treatment of
the measurement failed.
A calibration
error occurred.
(XX can be some
digital symbol,
such as 01,
02,etc., if this
similar situation
appear, all
belong to calibration error.)
Out of measurement range
Refasten the cuff and then
measure again.
Movement can affect the
measurement.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.
Relax for a moment.
Refasten the cuff and then
measure again. If the problem persists, contact your
physician.
– 28 –– 29 –
SPECIFICATIONS
Power supply
Display mode
Measurement modeOscillographic testing mode
Measurement range
Accuracy
Normal working condition
Storage & transportation
condition
Measurement perimeter of
the upper arm
WeightApprox.225g(Excluding the dry cells and cuff)
External dimensionsApprox.120.2mm×108.2mm×68.5mm
Attachment4×AAA batteries,user manual ,Flannelette bag
A temperature range of :+5°C to +40°C
A relative humidity range of 15% to 90%,
non-condensing, but not requiring a water
vapour
partial pressure greater than 50 hPa
An atmospheric pressure range of :
700 hPa to 1060 hPa
Temperature:-20°C to +60°C
A relative humidity range of ≤ 93%, non-condensing,
at a water vapour pressure up to 50hPa
About 22cm~32cm
Protection against ingress
of water
Device Classification
Software VersionA04
IP21 It means the device could protected
against solid foreign objects of 12.5mm and
greater, and protect against vertically falling
water drops.
Battery Powered Mode:
Internally Powered ME Equipment
WARNING: No modification of this equipment is allowed.
COMPLIED STANDARDS LIST
1. Complied Standards List
Risk management
Labeling
User manual
General
Requirements
for Safety
EN ISO 14971:2012 / ISO 14971:2007 Medical devices
- Application of risk management to medical devices
EN ISO 15223-1:2016 / ISO 15223-1:2016 Medical
devices.
Symbols to be used with medical device labels, labelling and information to be supplied. Part 1 : General
requirements
EN 1041:2008 Information supplied by the manufacturer of medical devices
EN 60601-1:2006+A1:2013/ IEC 606011:2005+A1:2012 Medical electrical equipment - Part
1: General requirements for basic safety and essential
performance
EN 60601-1-11:2015/ IEC 60601-1-11:2015 Medical
electrical equipment - Part 1-11: General requirements
for basic safety and essential performance - Collateral
standard: Requirements for medical electrical equipment and medical electrical systems used in the home
healthcare environment
– 30 –– 31 –
Electromagnetic
compatibility
Performance
requirements
Clinical
investigation
Usability
Software life-cycle processes
EN 60601-1-2:2015/ IEC 60601-1-2:2014 Medical
electrical equipment - Part 1-2: General requirements
for basic safety and essential performance - Collateral
standard: Electromagnetic disturbances - Requirements
and tests
EN ISO 81060-1:2012 Non-invasive sphygmomanometers - Part 1:
Requirements and test methods for non-automated
measurement type
EN 1060-3:1997+A2:2009 Non-invasive sphygmomanometers - Part 3: Supplementary requirements for
electro-mechanical blood pressure measuring systems
IEC 80601-2-30:2009+A1:2013 Medical electrical
equipment- Part
2-30: Particular requirements for the basic safety and
essential performance of automated non-invasive
sphygmomanometers
EN 1060-4:2004 Non-invasive sphygmomanometers Part 4: Test procedures to determine the overall system
accuracy of automated non-invasive sphygmomanometers
ISO 81060-2:2013 Non-invasive sphygmomanometers
- Part 2: Clinical validation of automated measurement
type
EN 60601-1-6:2010+A1:2015/IEC 60601-16:2010+A1:2013
Medical electrical equipment - Part 1-6: General
requirements for basic safety and essential performance
- Collateral standard: Usability
IEC 62366-1:2015 Medical devices - Part 1: Application
of usability engineering to medical devices
EN 62304:2006/AC: 2008 / IEC 62304: 2006+A1:2015
Medical device software - Software life-cycle processes
ISO 10993-1:2009 Biological evaluation of medical
devices- Part 1: Evaluation and testing within a risk
Bio-compatibility
management process ISO 10993-5:2009 Biological
evaluation of medical devices - Part 5: Tests for in vitro
cytotoxicity ISO 10993-10:2010 Biological evaluation
of medical devices - Part 10: Tests for irritation and skin
sensitization
EMC GUIDANCE
1. EMC Guidance
1) This product needs special precautions regarding EMC and
needs to be installed and put into service according to the
EMC information provided, and this unit can be affected by
portable and mobile RF communications equipment.
2) Do not use a mobile phone or other devices that emit elec-
tromagnetic fields, near the unit. This may result in incorrect
operation of the unit.
3) Caution: This unit has been thoroughly tested and inspected
to assure proper performance and operation!
4) Caution: This machine should not be used adjacent to or
stacked with other equipment and that if adjacent or stacked
use is necessary, this machine should be observed to verify normal operation in the configuration in which it will be
used.
Table 1
Guidance and manufacturer’s declaration – electromagnetic emissions
The device is intended for use in the electromagnetic environment specified below. The
customer or the user of the device should assure that it is used in such an environment.
internal function. Therefore, its RF emissions are very low and are not likely to
cause any interference in nearby electronic
equipment.
– 32 –– 33 –
RF emissions CISPR 11Class B
Harmonic emissions IEC
61000-3-2
Voltage fluctuations/ flicker
emissions IEC 61000-3-3
Class A
Complies
The device is suitable for use in all establishments, other than domestic and those
directly connected to the public low-voltage power supply network that supplies
buildings used for domestic purposes.
Table 2
Guidance and manufacturer’s declaration – electromagnetic immunity
The device is intended for use in the electromagnetic environment specified below. The
customer or the user of the device should assure that it is used in such an environment.
Immunity test
Electrostatic
discharge (ESD) IEC
61000-4-2
Electrical fast
transient/burst
IEC 61000-4-4
Surge IEC61000-4-5
IEC 60601
test level
±8 kV contact
±15 kV air
power supply lines:
±2 kV
input/output lines:
±1 kV
line(s) to line(s):
±1 kV
line(s) to earth:
±2 kV
100 kHz repetition
frequency
Compliance level
±8 kV contact
±15 kV air
power supply lines:
±2 kV
line(s) to line(s):
±1 kV
100 kHz repetition
frequency
Electromagnetic
environment guidance
Floors should be
wood, concrete
or ceramic tile.
If floors 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.
Voltage dips,
short interruptions
and voltage
variations on
power supply
input lines IEC
61000-4-11
Power frequency
(50Hz/60Hz)
magnetic field IEC
61000-4-8
NOTE U
is the a.c. mains voltage prior to application of the test level.
T
0% 0.5 cycle
At 0°, 45°, 90°, 135°,
180°,225°,270° and
315°
0% 1 cycle
and 70% 25/30
cycles
Single phase: at 0
0% 300 cycle
30 A/m
50Hz/60Hz
0% 0.5 cycle
At 0°, 45°, 90°, 135°,
180°,225°,270° and
315°
0% 1 cycle
and 70% 25/30
cycles
Single phase: at 0
0% 300 cycle
30 A/m
50Hz/60Hz
Mains power quality should be that
of a typical commercial or hospital
environment.
Power frequency
magnetic fields
should be at levels
characteristic of
a typical location in
a typical
commercial or hospital environment.
Table 3
Guidance and manufacturer’s declaration – electromagnetic immunity
The device is intended for use in the electromagnetic environment specified below.
The customer or the user of the device should assure that it is used in such an environment.
Immunity test
Conducted RF
IEC 61000-4-6
IEC 60601
Test level
150 kHz to
80 MHz:
3 Vrms
6Vrms (in ISM
and amateur
radio bands)
80% Am at
1kHz
Compliance
level
150 kHz to
80 MHz:
3 Vrms
6Vrms (in ISM
and amateur
radio bands)
80% Am at
1kHz
Electromagnetic environment guidance
Portable and mobile RF communications equipment should be
used no closer to any part of the
device, including cables, than the
recommended separation distance calculated from the equation
appropriate for the frequency of
the transmitter.
Recommended separation
distances:
d=0.35;
d=1.2
– 34 –– 35 –
where, P is
the maximum
output power
rating of the
transmitter in
watts (W)
according to
the transmitter
manufacturer,
d is the recommended separation distance
in meters (m).
Field strengths
80 MHz
Radiated RF
IEC 61000-4-3
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 device is used
exceeds the applicable RF compliance level above, the device should be observed to
verify normal operation. If abnormal performance is observed, additional measures may
be necessary, such as re-orienting or relocating the device.
b) Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3V/m.
10V/m, 80% Am
at 1kHz
10V/m, 80% Am
at 1kHz
to 800 MHz:
d=1.2
800 MHz
to 2.7 GHz:
d=2.3
from fixed RF
transmitters,
as determined
by an electromagnetic site
survey, should
be less than the
compliance
level in each
frequency
range.
Interference
may occur in
the vicinity
of equipment
marked with
the following
symbol:
Table 4
Recommended separation distances between portable and mobile RF communications
equipment and the device.
The device is intended for use in an electromagnetic environment in which radiated RF
disturbances are controlled. The customer or the user of the device can help prevent
electromagnetic interference by maintaining a minimum distance between portable and
mobile RF communications equipment (transmittters) and the device as recommended
below, according to the maximum output power of the
communications equipment.
Rated maximum
output
power of transmitter
(W)
0.010.120.120.23
0.10.370.380.73
11.21.22.3
103.83.87.3
100121223
For transmitters rated at a maximum output power not listed above, the recommended
separation distance d in metres (m) can be estimated using the equation applicable to the
frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer.
NOTE 1 At 80 MHz and 800 MHz, the separation distance for the higher frequency
range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is
affected by absorption and reflection from structures, objects and people.
Separation distance according to frequency of transmitter (m)
150 kHz to 80 MHz
d=3.5
80 MHz to 800 MHz
d=1.2
800 MHz to 2.7 GHz
d=2.3
– 36 –– 37 –
Table 5
Guidance and manufacturer’s declaration - electromagnetic immunity
The device is intended for use in the electromagnetic environment specified below. The
customer or the user of the device, should assure that it is used in such an environment.
IMMUNITY
TEST
LEVEL
(V/m)
28
9
Radiated RF
IEC
610004-3
(Test
specifications
for
ENCLOSURE
PORT
IMMUNITY
to RF
wireless
communications
equipment)
Test
Frequ-
ency
(MHz)
385380-390
450380-390
710
745
780
810
930
Band a)
(MHz)
704-787
800-960
Service a)Modula-
tion b)
Pulse
TETRA
modula-
400
tion b)
18Hz
FM c) ±
5kHz
GMRS
devia-
460,
tion
FRS 460
1kHz
sine
FM c) ±
GMRS
5kHz
460,
devia-
FRS 460
tion
1kHz
sine
LTE
Pulse
Band
modula-
13,
tion b)
17
217Hz
GSM
800/
900,
TETRA
Pulse
800,
modula-
iDEN
tion b)
820,
18Hz
CDMA
850,
LTE
Band 5
Modulation b)
(W)
1.80.327
20.328
2
0.2
20.328870
Distance (m)
0.3
0.3
GSM
1720
Radiated RF
IEC
610004-3
(Test
specifi-
1970
cations
for
ENCLOSURE
PORT
IMMUNITY
2450
to RF
wireless
communications
equip-
5240
ment)
5785
NOTE If necessary to achieve the IMMUNITY TEST LEVEL, the distance between the
transmitting antenna and the ME EQUIPMENT or ME SYSTEM may be reduced to 1 m.
The 1 m test distance is permitted by IEC 61000-4-3.
a) For some services, only the uplink frequencies are included.
b) The carrier shall be modulated using a 50% duty cycle square wave signal.
c) As an alternative to FM modulation, 50% pulse modulation at 18 Hz may be used
because while it does not represent actual modulation, it would be worst case.
The MANUFACTURER should consider reducing the minimum separation distance, based
on RISK MANAGEMENT, and using higher IMMUNITY TEST LEVELS that are appropriate
for the reduced minimum separation distance. Minimum separation distances for higher
IMMUNITY TEST LEVELS shall be calculated using the following equation:
E=6/d √P
Where P is the maximum power in W, d is the minimum separation distance in m, and E
is the IMMUNITY TEST LEVEL in V/m.
Batteries and electronic instruments must be disposed of in accordance
with the locally applicable regulations, not with domestics waste.
Established in 1949
B. WÓJCIK s-ka jawna
0 0 - 8 0 1 W arsaw , C hm ielna 9 8 Str.
w w w . techm ed. pl e- m ail: techm ed@ techm ed. pl
P oland, E u rope
1949 gegründet
P O L N I SC H E R
P R O DU Z E N T
DER ANFÜHRER
DES JAHRZEHNTS
BENUTZERHANDBUCH
DIGITALES BLUTDRUCK- UND HERZFREQUENZMESSGERÄT
MODEL: TMA-20 SMART
– 40 –– 1 –
AUFBAU DES GERÄTES
1. Symbole des LCD-Displays
mmHg
mmHg
/min
SYMBOLBESCHREIBUNGERKLÄRUNG
SYSSystolischer DruckHöheres Druckergebnis
DIADiastolischer Druck Niedrigeres Druckergebnis
PUL/min.PulsAnzahl der Herzschläge/Min.
mmHgmmHg
KlasseEinstufung der Druckwerte
Schwacher AkkuAkkus sind auszutauschen
ArrhythmieUnregelmäßiger Herzrhythmus
Messeinheit für Blutdruck-messung
(1 mmHg = 0,133 kPa)
J/M/T, Uhrzeit:
Min.
Pulssymbo
Aktuelles Datum und Uhrzeit
Während der Messung angezeigtes
Herzschlagsymbol
AVGDurchschnittswertDurchschnittswert der Blutdruckmessungen
2. Aufbau des Gerätes
3. Bestandteile des Kits
Druckmessgerät TMA-20 SMART Manschette 22-32 cm
4xAAA Alkalische Akkus Bedienungsanleitung
– 2 –– 3 –
GRUNDEINSTELLUNGEN
1. Einbau und Austausch von Akkus
Öffnen Sie den Deckel des Akkufachs. Legen Sie die Akkus nach
ihrer Polarität ein. Bringen Sie den Fachdeckel wieder an.
HINWEIS
Um die beste Funktion und den Schutz des Gerätes sicherzustel-
len, empfehlen wir die Verwendung von alkalischen Akkus.
Wechseln Sie die Akkus in den folgenden Fällen aus:
• erscheint auf dem Display
• Display wird dunkler
• Display funktioniert nicht
HINWEIS
• Verwenden Sie keine neuen und gebrauchten Akkus zusam-
men.
• Verwenden Sie keine verschiedenen Arten von Akkus (z.B.
normale und alkalische Akkus).
• Wird das Gerät längere Zeit nicht benutzt, entfernen Sie die
Akkus.
• Werfen Sie gebrauchte Akkus nicht ins Feuer. Sie können
auslaufen oder explodieren.
• Alte Akkus sind schädlich für die Umwelt, daher entsorgen
Sie sie nicht mit dem Hausmüll.
• Entfernen Sie alte Akkus von Ihrem Gerät und befolgen Sie
die örtlichen Vorschriften zur Wiederverwertung.
2. Einstellung von Datum, Uhrzeit und Maßeinheit
Bevor Sie die Messung durchführen, stellen Sie den Timer so ein,
dass jedes gespeicherte Ergebnis mit Datum und Uhrzeit der Ausführung gespeichert wird. Form der Aufzeichnung: Jahr - 201
7-2057, Uhrzeit - im 24-Stunden-Format
1. Nach Einlegen und Vorbereiten des Gerätes drücken halten Sie die
START/STOP-Taste 3 Sekunden lang gedrückt, um in den Jahreseinstellungsmodus zu wechseln.
– 4 –– 5 –
2. Drücken Sie die PAMIĘĆ-Taste (SPEICHER), um das Jahr auszuwählen. Mit jedem Tastendruck wird der Wert erhöht.
3. Nach Einstellen des Jahres drücken Sie die START/STOP-Taste,
um die Auswahl zu bestätigen und in die Monats- und Tageseinstellung zu wechseln.
4. Wiederholen Sie die Schritte 2 und 3, um den Monat und den Tag
einzustellen.
5. Wiederholen Sie die Schritte 2 und 3, um die Uhrzeit und die
Minuten einzustellen.
– 6 –– 7 –
6. Wenn Datum und Uhrzeit eingestellt und die Auswahl durch die
START/STOP-Taste bestätigt wurde, wird das Gerät angezeigt
und automatisch ausgeschaltet.
MESSUNG
1. Anbringen der Manschette
1. Bringen Sie die Manschette über dem freiliegenden linken
Arm an, so dass der Luftschlauch leicht in innere Richtung
des Arms verschoben ist, in einer Linie mit dem kleinen Finger.
2 ~ 3 cm
2. Die Manschette sollte zugedrückt werden, aber nicht zu fest.
Zwischen der Manschette und dem Arm sollte genug Platz
sein, um einen Finger einzuschieben. Die Manschette sollte
2-3 cm über der inneren Beugung im Ellenbogen befestigt
werden.
3. Setzen Sie sich bequem mit dem linken Arm auf eine ebene
Tischfläche gestützt, mit der Handinnenfläche nach oben.
Achten Sie darauf, dass die Hand frei liegt, spannen Sie die
Muskeln des Messarms nicht an. Die Manschette und das
Herz sollten sich zum Zeitpunkt der Messung ungefähr auf
der gleichen Höhe befinden.
4. Halten Sie Ihren Rücken bequem an den Stuhl gelehnt, legen
Sie Ihre Füße flach auf den Fußboden, lassen Sie die Beine
nicht überkreuzen.
5. Ruhen Sie sich vor der Messung 5 Minuten lang aus.
6. Führen Sie die Messung in Ruhe durch, ohne sich während
der Messung zu bewegen und zu sprechen.
7. Warten Sie zwischen den Messungen mindestens 15 Minu-
ten ab. Damit kann der normale Blutkreislauf im Arm wiederhergestellt werden.
8. Um vergleichbare Ergebnisse zu erzielen, versuchen Sie die
Messungen unter ähnlichen Bedingungen durchzuführen,
z.B. täglich zur gleichen Zeit, am gleichen Arm oder wie von
Ihrem Arzt verordnet.
– 8 –– 9 –
2. Beginn der Messung
1. Drücken Sie “START/STOP”-Taste, um das Gerät einzuschal-
ten und die Messung zu beginnen.
LCD-Display
Automatisches Aufblasen der
Manschette und Durchführung
der Messung. Mit der
G3MWI-Technik von der 3.
Generation wird die Messung
bereits beim Aufblasen der
Manschette ausgeführt.
Automatische Einstellung
der Null.
Erzielen des Ergebnisses und
automatisches Speichern im
Speicher.
2. Nach jeder ausgeführten Messung erscheint im Display ein
Symbol, mit dem das Ergebnis nach der WHO-Skala eingestuft wird. Für einen Druckwert von 120/80 mmHg ist dies
beispielsweise das Symbol
, das für ein richtiges Ergebnis
steht.
Die Beschreibung der Symbole der WHO-Skala ist in der Ta-
belle auf Seite 23 detailliert dargestellt.
3. Drücken Sie die „START/STOP”-Taste, um das Druckmess-
gerät auszuschalten, andernfalls wird das Gerät nach 1 Minute selbst ausgeschaltet.
– 10 –– 11 –
SPEICHER
1. Aufrufen von gespeicherten Ergebnissen
1. Wenn das Gerät ausgeschaltet ist, drücken Sie die PAMIĘĆ-
-Taste (SPEICHER), das AVG-Symbol wird im Display angezeigt - dies ist der Durchschnittswert der letzten drei Messungen. Wenn weniger als 3 Messungen im Speicher gespeichert
sind, wird die zuletzt gespeicherte Messung angezeigt.
2. Drücken Sie die PAMIĘĆ-Taste (SPEICHER), um die gespe-
icherten Ergebnisse anzuzeigen.
Das Ergebnis der Messung wird zusammen mit Datum und Uhrzeit
deren Ausführung angezeigt.
Eine beispielhafte Aufzeichnung zeigt, dass Nr. 1 das erste Ergebnis
aller 5 gespeicherten Messungen ist.
Datum der Ausführung
Uhrzeit der Ausführung
2. Löschen von gespeicherten Messungen aus dem Speicher
Ist die Messung nicht korrekt, können Sie alle Ergebnisse löschen,
indem Sie die folgenden Schritte ausführen.
1. Drücken Sie die PAMIĘĆ-Taste
(SPEICHER), um in den Modus
der gespeicherten Messungen zu
wechseln.
– 12 –– 13 –
2. Halten Sie die gleiche Taste 3 Sekun-
den lang gedrückt, bis im Display angezeigt, was bedeutet “Alle löschen”.
3. Halten Sie START/STOP-Taste ge-
drückt, um das Löschen zu bestätigen, nach einer Weile wird in der
unteren Ecke angezeigt und das Gerät
wird automatisch ausgeschaltet.
4. Wenn Sie die Aufzeichnungen
nicht löschen möchten, drücken
Sie die “START/STOP”-Taste, um
den Ergebnislöschmodus zu verlassen und die Aufzeichnungen
im Speicher zu lassen.
5. Wenn es keine gespeicherten Er-
gebnisse im Speicher gibt, wird
das Display wie rechts aussehen.
HINWEISE FÜR BENUTZER
HINWEISE ZUR AUSFÜHRUNG DER MESSUNG
Die Durchführung der Messung in den folgenden Fällen kann zu Fehlern führen.
Die Ausführung der Messungen
sofort nach dem Essen oder
Trinken.
Die Ausführung der
Messung sofort nach dem
Trinken von Tee, Kaffee
oder nach Rauchen.
Die Ausführung der Messung
sofort nach dem Baden.
Beim Sprechen oder Bewegen der Finger.
An einem sehr kühlen Ort.Wenn Sie urinieren
möchten.
– 14 –– 15 –
REINIGUNG UND WARTUNG
Um eine optimale Funktion zu erzielen, beachten Sie die folgenden
Empfehlungen.
Lagern Sie das Gerät in einem
trockenen Ort und vor Sonnenlicht geschützt.
Vermeiden Sie Schütteln und
Stöße.
Vermeiden Sie den Kontakt
mit Wasser, reinigen Sie
das Gerät ggf. mit einem
trockenen Tuch.
Vermeiden Sie staubige
Orte und Orte mit wechselnden Temperaturen.
Verwenden Sie zum Entfernen
größerer Verunreinigungen ein
Waschen Sie die Manschette nicht mit Wasser.
feuchtes Tuch.
FEHLERBEHEBUNG
PROBLEM ANZEICHEN PRÜFENABHILFE
Kein
Strom
Schwacher Akku
Das Display
leuchtet
nicht
Display
Leere AkkusErneuern Sie die Akkus.
Im
Falsch eingelegte
Akkus.
Schwacher
Akku.
– 16 –– 17 –
Legen Sie die Akkus richtig
ein.
Erneuern Sie die Akkus.
Fehlermeldung
Fehlermeldung
E01 wird
angezeigt
E02 wird
angezeigt
E03 wird
angezeigt
E04 wird
angezeigt
EExx wird
angezeigt
“out” wird
angezeigt
Die Manschette
ist entweder
zu fest oder zu
locker befestigt.
Durch das
Gerät wurde
eine Bewegung während
der Messung
erkannt.
Während der
Messung wurde
kein Puls erkannt.
Die Messung ist
fehlgeschlagen.
Es ist ein Kalibrierungsfehler
aufgetreten. Dieses Fehlersymbol
(xx) erscheint als
Ziffern.
Messung
außerhalb des
Bereichs
Korrigieren Sie die Manschette und führen Sie die
Messung erneut aus
Mit dieser Bewegung kann
das Messergebnis beeinflusst werden. Warten Sie
eine Weile ab und führen
Sie die Messung erneut
aus, ohne sich dabei zu
bewegen.
E10 oder E11 wird angezeigt
Entspannen Sie sich und
führen Sie die Messung
erneut aus.
Führen Sie die Messung
erneut aus. Sollte das
Problem immer noch nicht
beseitigt werden, wenden
Sie sich bitte an den Kundendienst des Herstellers.
Lösen Sie die Manschette,
entspannen Sie sich und
führen Sie die Messung
erneut aus. Wenn das
Problem mehrmals auftritt,
wenden Sie sich an Ihren
Arzt.
ACHTUNG: Änderungen an diesem Gerät sind nicht gestattet. Wird
das Gerät in einem Temperatur- und Feuchtigkeitsbereich gelagert
oder verwendet, der über die oben genannten Kenndaten hinausgeht,
kann es nicht gemäß der Vorgaben funktionieren.
– 18 –– 19 –
Entsorgung
Batterien und elektronische Geräte müssen gemäß den örtlich geltenden Vorschriften entsorgt werden, nicht mit dem Hausmüll.
1949 gegründet
B. WÓJCIK s-ka jawna
0 0 - 8 0 1 W arschau , C hm ielna 9 8 Str.
w w w . techm ed. pl e- m ail: techm ed@ techm ed. pl
P olen, E u rope
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