0 0 - 8 0 1 W a r s z a w a , u l . C h m i e l n a 9 8
B IU R O H A N D L O W E : t e l . : ( 2 2 ) 6 5 4 6 4 9 2
S K L E P F I R M O W Y : te l . : (2 2 ) 6 5 4 6 4 9 3
S E R W I S : t e l . : (2 2 ) 8 5 3 3 0 1 0 , f a k s : ( 2 2 ) 6 2 0 7 7 4 2
w w w . t e c h m e d . p l e - m a i l: t e c h m e d @ t e c h m e d . p l
Po l a n d , E u r o p e
Page 33
Established in 1949
LEADER OF THE
PO L ISH
PR O D UC E R
DECADE
USER MANUAL
DIGITAL BLOOD PRESSURE AND HEART RATE MONITOR
MODEL: TMA-3 BASIC
Page 34
INTRODUCTION
1. General Description
Thank you for selecting TECH-MED arm type blood pressure mo-
nitor (TMA-3 BASIC). The monitor features blood pressure measurement, pulse rate measurement and the result storage. The
design provides you with two years of reliable service.
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:
41*60mm Ditital LCD display
Maximum 60 records
Measuring during inflation technology
2. Indications for Use
The TECH-MED Blood Pressure Monitor is digital mo-
nitors intended for use in measuring blood pressu-
re and heartbeat rate with arm circumference ranging
from 23cm to 33cm. It is intended for adult indoor use only.
3. Contraindications
1. The device should not be used by any person who may be
suspected of,or is pregnant .
2. The device is not suitable for use on patients with implanted,electrical devices, such as cardiac pacemakers, defibrillators.
4. 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 atomospheric 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 –
Page 35
5. 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”
– 3 –
Page 36
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.
For indoor use only
Symbol for “Class II Equipment”
F1
T1A/250V 3.6*10CCC
– 4 –
Page 37
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.
* 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.
* 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.
– 5 –
Page 38
* 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 samb 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.
CAUTION
* 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.
– 6 –
Page 39
* 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 in a dry room and protect it aga-
inst 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.
* 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 batteries 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 and the cuff are suitable for use
within the patient environment. If you are allergic to polyester,
nylon or plastic, please don’t use this device.
* During use, the patient will be in contact with the cuff.
The materials of the cuff have been tested and found to
comply with requirements of ISO 10993-5:2009 and ISO
10993-10:2010. It will not cause any potential sensization or ir-
ritation reaction.
* 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.
– 7 –
Page 40
* 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 washing,
skin condition, and storage state. The typical service life is 10000
times.
CAUTION
* 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 operator shall not touch output of batteries 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
Transtek. 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 Transtek if any unexpected operation or events
occur.
– 8 –
Page 41
* 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.
* 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 distance
d is calculated 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.
– 9 –
Page 42
6. LCD Display Signal
SYMBOLDESCRIPTIONEXPLANATION
SYSSystolic pressureHigh blood pressure
DIADiastolic pressure Low blood pressure
PUL/min.Pulse displayPulse in beats per minute
Deflation symbolThe cuff is deflating.
Current TimeYear/Month/Day, Hour/Minute
Memory
kPaUnitMeasurement Unit of Blood Pressure
mmHgUnitMeasurement Unit of Blood Pressure
Low batteryBatteries are low and need to be replaced
Irregular heartbeat
Indicate it is in the memory mode and
which group of memory it is.
Blood pressure monitor is detecting an
irregular heartbeat during measurement.
– 10 –
Page 43
I
Blood pressure
level indicator
Heartbeat
Indicate the blood pressure level
Blood pressure monitor is detecting
a heartbeat during measurement.
7. Monitor components
CUFF
AIR PIPE
AIR CONNECTOR PLUG
LCD DISPLAY
UST
Component list of pressure measuring system
1 Cuff
2 Air pipe
3 PCBA
4 Pump
5 Valve
BATTERY COMPARTMENT
PAM
PAM BUTTON
UST BUTTON
Start/Stop BUTTON
– 11 –
Page 44
BEFORE YOU START
1. The Choice of Power Supply
1. Battery powered mode: 6VDC 4*AA batteries
2. AC adaptor powered mode: 6V 1A (Please only use the recommended AC adaptor model). Please unplug the adaptor
to depart from the using utility power.
PAM
UST
AC a d a p t o r
CAUTION
In order to get the best effect and protect your monitor,please use
the right battery and special power adaptor which complies with
local safety standard.
2. Installing and Replacing the Batteries
• Slide off the battery cover.
• Install the batteries by matching the correct polarity, as shown.
• Replace the cover.
– 12 –
Page 45
Replace the batteries whenever the below happens
The shows The display is dim
The display does not light up.
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, Time and Measurement Unit
It is important to set the clock
before using your blood pressure
monitor, so that a time stamp can
Yr
UST
be assigned to each record that
is stored in the memory. (The
setting range of the year :2000—
2050 time format:24 H)
1. When the monitor is off, hold
Yr
PAM
pressing “UST” for 3 seconds to
enter the mode for year setting.
2. Press the “PAM” to change the
[YEAR]. Each press will increase
the numeral by one in a cycling
manner.
Yr
UST
3. When you get the right year,
press “UST” to set down and turn
to next step.
– 13 –
Page 46
4. Repeat step 2 and 3 to set the [MONTH] and [DAY].
PAM
UST
PAM
UST
MD
Start
Stop
MD
Start
Stop
5. Repeat step 2 and 3 to set the [HOUR] and [MINUTE].
PAM
UST
Start
Stop
PAM
UST
Start
Stop
6. Repeat step 2 and 3 to set the [UNIT].
PAM
UST
Start
Stop
PAM
UST
Start
Stop
7. After the unit is set,the right picture will be shown,then it will turn
off.
– 14 –
Page 47
MEASUREMENT
2 ~ 3 c m
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 circulation 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.
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 ap-
proximately 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.
– 15 –
Page 48
6. Helpful tips for Patients, especially for Patients with Hyper-
tension:
• Rest for 5 minutes before first measurement
• 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.
2. Start the Measurement
1. When the monitor is off, press the “Start/Stop” to
turn on the monitor, and it will finish the whole
measurement.
LCD display Adjust the zero point.
Start
Stop
– 16 –
Page 49
Inflating and measuring. Display and save the results .
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, press the “PAM” to
show the last record.
2. Press the “PAM” or “UST” to get the record you want.
D O W NUP
UST
PAM
– 17 –
Start
Stop
PAM
Page 50
MD
Th e c u r r e n t i s t h e N o 1 8 .Th e c o r r e s p o n d in g
Th e c o r r e s p o n d in g
d a t e i s 1 1 t h O c t o b e r .
t i m e i s 1 0 : 3 8 .
The date and time of the record will be shown alternately.
The current is the No 18.
The corresponding date is 11th October.
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.
2. Delete the Records
If you did not get the correct measurement, you can delete all
results by following below steps.
1. When the monitor
is off, hold pressing
“PAM” for 3 seconds
PAM
,“dEL+ALL” will flash
on the display.
2. Press “UST” to confirm deleting and the
monitor will display
“dEL donE”,and then
turn off.
3. If you don’t want to
UST
delete the records,
press “Start/Stop” to
escape.
– 18 –
Page 51
4. If there is no record,
the right display will
be shown on the LCD.
Start
Stop
INFORMATION FOR USER
Tips for Measurement
Measurements may be inaccurate if taken in the following circumstances.
Within 1 hour after dinner or
drinking
Immediate measurement
after tea, coffee, smoking
– 19 –
Page 52
Within 20 minutes after taking
a bath
When talking or moving
your fingers
In a very cold environmentWhen you want to dischar-
ge urine
– 20 –
Page 53
MAINTENANCE
Please calibrate the blood pressure monitor in specific institute once
every two years to ensure the precise measurement. In order to get
the best performance, please follow the instructions below for storage.
Put in a dry place and avoid the
sunshine
Avoid touching water,
clean it with a dry cloth
in case.
Avoid intense shaking and
collisions
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.
– 21 –
Page 54
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.
Sy s t o l i c
b lo o d d i s c h a r g i n g
a r t e r y
p r e s s
D i a s t o l ic
b lo o d e n te r i n g
v e in
r e la x
2. What is the standard blood pressure classification?
The blood pressure classification published by World Health
Organization (WHO) and International Society of Hypertension
(ISH) in 1999 is as follows:
Systolic
pressure
(mmHg)
High blood pressure
Moderate hypertension
Slight hypertension
High pressure, normal
Normal pressure
Optimal
pressure
– 22 –
Diastolic
pressure
(mmHg)
Page 55
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
Hypertension
S1S2S3
3. Irregular Heartbeat Detector
An irregular heartbeat is detected when a heartbeat rhythm va-
ries while the device is measuring systolic pressure and diastolic
pressure. During each measurement, blood pressure monitor will
keep a record of all the pulse intervals and calculate the average value of them. 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%, then the irregular heartbeat
symbol will appear on the display with the measurement result.
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.
– 23 –
Page 56
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.
5. 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 me-
asuring.
Advice: Relax yourself for 4-5 minutes until you calm down.
6. 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
weather, emotion, exercise etc, Also, there is the “white coat”
effect, which means blood pressure usually increases in clinical
settings.
7. 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.
– 24 –
Page 57
TROUBLESHOOTING
This section includes a list of error messages and frequently asked
questions for problems you may encounter with your blood pressure
monitor. If the products not operating as you think it should, check
here before arranging for servicing.
PROBLEM SYMPTOMCHECK THISREMEDY
No power
Low
batteries
Display will
not light up.
Display is
dim or show
Batteries are
exhausted.
Batteries are
inserted incorrectly.
AC adaptor is
inserted incorrectly.
Batteries are low. Replace with new batteries
Replace with new batteries
Insert the batteries correctly
Insert the AC adaptor tightly
Error
message
E 1 shows
E 2 shows
E 3 shows
E10 or E11
shows
The cuff is not
secure.
The cuff is very
tight
The pressure
of the cuff is
excess.
The monitor detected
motion,talking
or the pluse is
too poor while
measuring.
– 25 –
Refasten the cuff and then
measure again.
Refasten the cuff and
then measure again.
Relax for a moment and
then measure again.
Relax for a moment and
then measure again.
Page 58
Error
message
E20 shows
E21 shows
EExx,shows
on the
display.
The measurement process
does not detect
the pulse signal.
The treatment of
the measurement
failed.
A calibration
error occurred.
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.
SPECIFICATIONS
Battery powered mode:
Power supply
Display modeDigital LCD display V.A.41mm*60mm
Measurement modeOscillographic testing mode
Measurement range
Accuracy
6VDC 4*AA batteries
AC adaptor powered mode: 6V 1A
(Please only use the recommended AC
adaptor model).
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
– 28 –
Page 61
General Requirements for Safety
Electromagnetic
compatibility
Performance
requirements
Clinical
investigation
Usability
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
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
– 29 –
Page 62
Software life-cycle processes
Bio-compatibility
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
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.
– 30 –
Page 63
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.
Voltage fluctuations/ flicker
emissions IEC 61000-3-3
Class A
Complies
internal function. Therefore, its RF emissions are very low and are not likely to
cause any interference in nearby electronic
equipment.
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
IEC 60601
test level
±8 kV contact
±15 kV air
power supply lines:
±2 kV
input/output lines:
±1 kV
Compliance level
±8 kV contact
±15 kV air
power supply lines:
±2 kV
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.
– 31 –
Page 64
line(s) to line(s):
±1 kV
Surge IEC61000-4-5
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
line(s) to earth:
±2 kV
100 kHz repetition
frequency
0%UT; 0.5 cycle
At 0°, 45°, 90°, 135°,
180°,225°,270° and
315°
0%UT ; 1 cycle
and 70%UT ; 25/30
cycles
Single phase: at 0°
0% UT ; 300 cycle
30 A/m
50Hz/60Hz
line(s) to line(s):
±1 kV
100 kHz repetition
frequency
0% UT ; 0.5 cycle
At 0°, 45°, 90°, 135°,
180°,225°,270° and
315°
0% UT ; 1 cycle
and 70% UT ;
25/30 cycles
Single phase: at 0°
0% UT ;300 cycle
30 A/m
50Hz/60Hz
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.
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√P;
d=1.2 √P
– 32 –
Page 65
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 to 800
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
MHz:
d=1.2√P
800 MHz to
2.7 GHz:
d=2.3√P
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:
– 33 –
Page 66
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√P
80 MHz to 800 MHz
d=1.2√P
800 MHz to 2.7 GHz
d=2.3√P
– 34 –
Page 67
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.
Distance (m)
IMMUNITY
TEST
LEVEL
(V/m)
Radiated RF
IEC
610004-3
(Test
specifications
for
ENCLOSURE
PORT
IMMUNITY
to RF
wireless
communications
equipment)
Test
Frequency
(MHz)
385380-390
450380-390
710
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
Pulse
LTE
modula-
Band
tion b)
13, 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
0.20.39745
20.328870
– 35 –
Page 68
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.
(Stromversorgung ist nur über das von TECH-MED empfohlene
Netzteil möglich)
– 3 –
Page 74
Um die Nutzung des Netzteils zu unterbrechen, trennen Sie das
Netzteil.
HINWEIS
Um die beste Funktion und den Schutz des Gerätes sicherzustel-
len, empfehlen wir die Verwendung von alkalischen Akkus oder
einem von TECH-MED empfohlenen Netzteil.
Wechseln Sie die Akkus in den folgenden Fällen aus:
• erscheint auf dem Display
• Display wird dunkler
• Display funktioniert nicht
HINWEIS
• Wird das Gerät längere Zeit nicht benutzt, entfernen Sie die
Akkus.
• Gebrauchte Akkus sind schädlich für die Umwelt, daher ent-
sorgen Sie sie nicht mit dem Hausmüll.
• Entfernen Sie gebrauchte Akkus von Ihrem Gerät und befol-
gen 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 - 20002050, Uhrzeit - im 24-Stunden-Format
1. Nach Einlegen und Vorbe-
reiten des Gerätes drücken
halten Sie die UST-Taste 3 Sekunden lang gedrückt, um in
den Jahreseinstellungsmodus
zu wechseln.
– 4 –
Page 75
2. Drücken Sie die PAM-Taste,
um das Jahr auszuwählen. Mit
jedem Tastendruck wird der
Wert erhöht.
3. Nach Einstellen des richtigen
Jahres drücken Sie die Taste
“UST”, um die Auswahl zu
bestätigen und zum weiteren
Schritt zu wechseln.
4. Wiederholen Sie die Schritte 2 und 3, um [MONAT] und [TAG]
einzustellen.
5. Wiederholen Sie die Schritte 2 und 3, um [STUNDE] und [MINUTEN] einzustellen.
– 5 –
Page 76
6. Wiederholen Sie die Schritte 2 und 3, um die [MAßEINHEIT] einzustellen: mmHg oder kPa.
7. Nach Einstellen der Maßeinheit wird das unten gezeigte Bild angezeigt und danach wird das Gerät automatisch abgeschaltet.
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 c m
– 6 –
Page 77
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 3 Minuten
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.
2. Beginn der Messung
1. Drücken Sie “START/STOP”-Taste, um
das Gerät einzuschalten und die Messung zu
beginnen.
Start
Stop
– 7 –
Page 78
LCD-Display. Automatische Einstellung der Null.
Automatisches Aufblasen der Erzielen des Ergebnisses
Manschette und und automatisches
Durchführung der Messung. Speichern im Speicher.
2. Drücken Sie die “START/STOP”-Taste, um das Gerät
auszuschalten, andernfalls wird das Gerät nach 1 Minute automatisch ausgeschaltet.
– 8 –
Start
Stop
Page 79
SPEICHER
1. Aufrufen von gespeicherten Ergebnissen
1. Drücken Sie die “PAM”-Taste, um die letzte Au-
fzeichnung anzuzeigen.
2. Drücken Sie die “PAM”- oder “UST”-Taste, um
in den gesuchten Eintrag zu wechseln.
D O W NUP
PAM
UST
Nummer der Messung im Speicher
Aktuelles Datum:
11. Oktober
Zeit: 10:38.
HINWEIS
Zuerst wird die neueste Aufzeichnung (1) angezeigt. Jeder
nachfolgenden Messung wird eine fortlaufende Nummer zugewiesen. Nachfolgende Aufzeichnungen werden um eine Stelle
nach unten verschoben (z.B. 2 wird zu 3 usw.) und die letzte
Aufzeichnung (60) wird aus der Liste entfernt.
PAM
– 9 –
Page 80
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. Halten Sie die “PA-
M”-Taste 3 Sekunden
lang gedrückt, im
Display wird angeze-
PAM
igt, was bedeutet “Alle
löschen”.
2. Drücken Sie die
“UST”-Taste, um das
Löschen zu bestätigen. Im Display wird
angezeigt und das
Gerät wird automatisch ausschaltet.
UST
3. Wenn Sie die Au-
fzeichnungen nicht
löschen möchten,
drücken Sie die
“START/STOP”-Taste, um den Ergebnislöschmodus zu
verlassen und die Aufzeichnungen im Speicher zu lassen.
4. Wenn es keine gespeicherten Ergebnisse im Speicher gibt,
wird das Display wie rechts aussehen.
– 10 –
Page 81
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
Verwenden Sie zum Entfernen
größerer Verunreinigungen ein
feuchtes Tuch.
Vermeiden Sie den Kontakt
mit Wasser, reinigen Sie
das Gerät ggf. mit einem
trockenen Tuch.
Vermeiden Sie staubige
Orte und Orte mit wechselnden Temperaturen.
Waschen Sie die Manschette nicht mit Wasser.
– 11 –
Page 82
FEHLERBEHEBUNG
PROBLEM ANZEICHEN PRÜFENABHILFE
Kein
Strom
Schwacher Akku
Fehlermeldung
Das Display
leuchtet
nicht
Im Display
E1 wird
angezeigt
E2 wird
angezeigt
E3 wird
angezeigt
E10 oder
E11 wird
angezeigt
E20 oder
E21 wird
angezeigt
Eexx wird
angezeigt
Leere AkkusErneuern Sie die Akkus.
Falsch eingelegte
Akkus.
Schwacher
Akku.
Die Manschette
ist entweder
zu fest oder zu
locker befestigt.
Die Manschette
ist sehr eng.
Während der
Messung wurde
kein Puls erkannt.
Durch das
Gerät wurde
eine Bewegung während
der Messung
erkannt.
Falsche
Messung.
Es ist ein Kalibrierungsfehler
aufgetreten (an
der xx-Stelle
können Ziffern
erscheinen).
Legen Sie die Akkus richtig
ein.
Erneuern Sie die Akkus.
Korrigieren Sie die Manschette und führen Sie die
Messung erneut aus.
Korrigieren Sie die Manschette und führen Sie die
Messung erneut aus.
Lockern Sie die hochgekrempelte Kleidung
auf dem Arm und führen
Sie nach einer Weile die
Messung erneut aus.
Mit dieser Bewegung kann
das Messergebnis beeinflusst werden. Warten Sie
eine Weile ab und führen
Sie die Messung erneut aus.
Warten Sie eine Weile ab
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 Ihren Händler
oder unseren Kundendienst.
– 12 –
Page 83
TECHNISCHE DATEN
Akkubetrieb: 6V DC 4* Akkus AA
Spannungsversorgung
Typ des Displays
MessverfahrenOszillometrisches Prüfverfahren
Messbereich
Genauigkeit
Normale Betriebsbedingungen
Lager- und Transportbedingungen
Umfang des gemessenen
Arms
Gewicht257 g (ohne Akkus)
AbmessungCa. 140*120*70 mm
AC-Netzteil-Stromversorgung:100-240 V~, 5660 HZ, 400 mA (Option)
Es kann nur mit dem von TECH-MED empfohlenen AC/DC-Netzteil versorgt werden)
Digitales hintergrundbeleuchtetes blaues mit
weißen Ziffern LCD, 60 mm x 41 mm
Druck:
5°C~40°C mit einer Genauigkeit von bis zu
± 3 mmHg (0,4 kPa)
Pulswert: ±5%
Temperatur: 5°C~40°C, Relative Luftfeuchtigkeit:
15% ~90%, nicht kondensierend, bei einem
Wasserdampfdruck von bis zu 50 hPa.
Atmosphärischer Druckbereich 700~1060 hPa.
Temperatur: -20°C~60°C Relative Luftfeuchtigkeit: ≤ 93%, nicht kondensierend, Wasserdampfdruck von bis zu 50 hPa.