Buku Manual (Inggris)
Buku Manual (Inggris)
Buku Manual (Inggris)
User Manual
Blood Pressure Monitor
Type:SMART
Production by:
Thank you very much for selecting Minar Blood Pressure Monitor Type:SMART
Please read the user manual carefully and thoroughtly so as to ensure the
safe usage of this product, and keep the manual well for further reference in
EC REP case you have problems.
CATALOGUE CATALOGUE
Table of Contents
INTRODUCTION.................................................................................................................2
General Description
Indications for Use
Contraindications
Measurement Principle
Safety Information
LCD Display Signal
Monitor Components
List
MEASUREMENT................................................................................................................13
Tie the Cuff
Start the Measurement
DATA MANAGEMENT........................................................................................................16
Recall the Records
Delete the Records
TROUBLESHOOTING.......................................................................................................22
SPECIFICATIONS.............................................................................................................23
EMC GUIDANCE...............................................................................................................24
CONTACT INFORMATION................................................................................................27
1
INTRODUCTION INTRODUCTION
The Minar Blood Pressure Monitor is digital monitors intended for use in
Symbol for “DIRECT CURRENT” Symbol for “RECYCLE”
measuring blood pressure and heartbeat rate with arm circumference ranging
from 22 cm to 42 cm ( about 8¾˝-16½˝ ).
Symbol for “MANUFACTURE Symbol for “authorised representative
It is intended for adult indoor use only. DATE” in the European Community”
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
atmospheric 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
INTRODUCTION INTRODUCTION
CAUTION
CAUTION
* This device is intended for adult use in homes only. * When measurement, please avoid compression or restriction of the connection tubing.
* The device is not suitable for use on neonatal patients, pregnant women,patients with * The device cannot be used with HF surgical equipment at the same time.
implanted, electronical devices, patients with pre-eclampsia, premature ventricular beats, * The ACCOMPANYING DOCUMENT shall disclose that the SPHYGMOMANOMETER
atrial fibrillation, peripheral, arterial disease and patients undergoing intravascular therapy was clinically investigated according to the requirements of ISO 81060-2:2013.
or arterio-venous shunt or people who received a mastectomy. Please consult your doctor * To verify the calibration of the AUTOMATED SPHYGMOMANOMETER, please contact
prior to using the unit if you suffer from illnesses. the manufacturer.
* The device is not suitable for measuring the blood pressure of children. Ask your doctor * This device is contraindicated for any female who may be suspected of, or is pregnant.
before using it on older children. Besides providing inaccurate readings, the effects of this device on the fetus are unknown.
* The device is not intended for patient transport outside a healthcare facility. * Too frequent and consecutive measurements could cause disturbances in blood
* The device is not intended for public use. circulation and injuries.
* This device is intended for no-invasive measuring and monitoring of arterial blood * This unit is not suitable for continuous monitoring during medical emergencies or
pressure.It is not intended for use on extremities other than the arm or for functions other operations.Otherwise, the patient’s arm and fingers will become anaesthetic, swollen and
than obtaining a blood pressure measurement. even purple due to a lack of blood.
* Do not confuse self-monitoring with self-diagnosis. This unit allows you to monitor your * When not in use, store the device with the adapter in a dry room and protect it against
blood pressure.Do not begin or end medical treatment without asking a physician for extreme moisture, heat, lint, dust and direct sunlight. Never place any heavy objects on the
treatment advice. storage case.
* If you are taking medication,consult your physician to determine the most appropriate time * This device may be used only for the purpose described in this booklet. The
to measure your blood pressure. Never change a prescribed medication without consulting manufacturer cannot be held liable for damage caused by incorrect application.
your physician. *This device comprises sensitive components and must be treated with caution. Observe
* Do not take any therapeutic measures on the basis of a self measurement. Never alter the storage and operating conditions described in this booklet.
the dose of a medicine prescribed by a doctor. Consult your doctor if you have any * The equipment is not AP/APG equipment and not suitable for use in the presence of a
question about your blood pressure. flammable anesthetic mixture with air of with oxygen or nitrous oxide.
* When the device was used to measure patients who have common arrhythmias such as * Warning: No servicing/maintenance while the ME equipment is in use.
atrial or ventricular premature beats or atrial fibrillation, the best result may occur with * The patient is an intended operator.
deviation. Please consult your physician about the result. * The patient can measure and change batteries under normal circumstances and
* Don't kink the connection tube during use, otherwise, the cuff pressure may continuously maintain the device and its accessories according to the user manual.
increase which can prevent blood flow and result in harmful injury to the PATIENT. * To avoid measurement errors, please avoid the condition of strong electromagnetic field
radiated interference signal or electrical fast transient/burst signal.
* When using this device, please pay attention to the following situation which may interrupt
*The blood pressure monitor, its adaptor, and the cuff are suitable for use within the
blood flow and influence blood circulation of the patient, thus cause harmful injury to the
patient environment. If you are allergic to polyester, nylon or plastic, please don't use this
patient: connection tubing kinking too frequent and consecutive multiple measurements; the
device.
application of the cuff and its pressurization on any arm where intravascular access or
* During use, the patient will be in contact with the cuff. The materials of the cuff have
therapy, or an arterio-venous (A-V) shunt, is present; inflating the cuff on the side of a
been tested and found to comply with requirements of ISO 10993-5:2009 and ISO
mastectomy.
10993-10:2010. It will not cause any potential sensitization or irritation reaction.
* Warning: Do not apply the cuff over a wound;otherwise it can cause further injury.
* Adaptor is specified as a part of ME EQUIPMENT.
*Do not inflate the cuff on the same limb which other monitoring ME equipment is applied
* If you experience discomfort during a measurement, such as pain in the arm or other
around simultaneously, because this could cause temporary loss of function of those complaints, press the START/STOP button to release the air immediately from the cuff.
simultaneously-used monitoring ME equipment. Loosen the cuff and remove it from your arm.
*On the rare occasion of a fault causing the cuff to remain fully inflated during * If the cuff pressure reaches 40 kPa (300 mmHg), the unit will automatically deflate.
measurement, open the cuff immediately. Prolonged high pressure (cuff pressure > Should the cuff not deflate when pressures reaches 40 kPa (300 mmHg), detach the cuff
300mmHg or constant pressure > 15mmHg for more than 3 minutes) applied to the arm from the arm and press the START/STOP button to stop inflation.
may lead to an ecchymosis. * Before use, make sure the device functions safely and is in proper working condition.
*Please check that operation of the device does not result in prolonged impairment of Check the device, do not use the device if it is damaged in any way. The continuous use of
patient blood circulation. a damaged unit may cause injury, improper results, or serious danger.
4 5
INTRODUCTION INTRODUCTION
6 7
INTRODUCTION BEFORE YOU START
Component list of
Monitor Components pressure measuring system Installing and Replacing the Batteries
1 Cuff
2 Air pipe • Open the battery cover.
3 PCBA • Install the batteries as indicated in
CUFF 4 Pump
the battery compartment.
5 Valve
(Always select the
AIR HOSE
authorized / specified
battery: Four AAA-size batteries).
• Replace the battery cover.
AIR CONNECTOR PLUG Replace the batteries whenever the below happen
The shows
MEM BUTTON
SET BUTTON
The display is dim
START/STOP BUTTON
The display does not light up
BATTERY COMPARTMENT
LCD DISPLAY
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.
List
1.Blood Pressure Monitor 2.Cuff (Type BF applied part)
Type:SMART (22 cm ~ 42 cm)
8 9
BEFORE YOU START BEFORE YOU START
Setting Date, Time and Measurement Unit 5. Repeat steps 2 and 3 to set the [HOUR] and [MINUTE].
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: 2021—2061
time format: 24H)
1. When the monitor is off, long press
the “SET” button for 3 seconds to
enter the mode for year setting. Or
when the monitor is off, press “ SET ”
button shortly, it will display the time
and the User ID. Then hold pressing
“ SET “ button to enter the mode for
year setting.
6. Repeat steps 2 and 3 to set the [UNIT].
2. Press the “MEM” button to
change the [YEAR].
Each press the “MEM” button
will increase the numeral by
one in a cycling manner.
Long press the “MEM” button
to quickly advance the years.
10 11
BEFORE YOU START MEASUREMENT
2.Then press the “SET” button again to select the user ID between user 1 and 5. Sit comfortably with your tested arm resting on
a flat surface. Place your elbow on a table
user 2. 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. 2~3cm
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
3. After selecting the desired user ID, press the “START/STOP” button to similar conditions. For example, take daily measurements
at approximately the same time, on the same arm,
confirm. Then the LCD will turn off. or as directed by a physician.
S TO P
S TA R T
12 13
MEASUREMENT MEASUREMENT
14 15
DATA MANAGEMENT DATA MANAGEMENT
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
16 17
INFORMATION FOR USER INFORMATION FOR USER
Within 20 minutes
after taking a bath When talking or moving your fingers
Using wet cloths to remove dirt Do not attempt to clean the reusable cuff
with water and never immerse the cuff in
water.
18 19
ABOUT BLOOD PRESSURE ABOUT BLOOD PRESSURE
What are systolic pressure and diastolic pressure? Why does my blood pressure
When ventricles contract and pump blood out
of the heart, the blood pressure reaches its
Systolic Diastolic fluctuate throughout the
blood discharging blood entering
maximum value in the cycle, which is called artery vein day?
systolic pressure. When the ventricles relax,
press relax
the blood pressure reaches its minimum value 1. Individual blood pressure varies
in the cycle, which is called diastolic pressure. multiple times everyday. It is also affected
by the way you tie your cuff and your
What is the standard blood pressure classification? measurement position, so please take the
measurement under the same conditions.
The blood pressure classification published S TO P
S TA R T
by World Health Organization (WHO) and 2.If the person takes medicine, the
International Society of Hypertension (ISH) pressure will vary more.
in 1999 is as follows: 3.Wait at least 3 minutes for another
measurement.
CAUTION
Only a physician can tell your normal BP range. Why do I get a different What you need to pay
Please contact a physician if your measuring
result falls out of the range. Please note that
blood pressure at home attention to when you measure
your blood pressure at home:
only a physician can tell whether your blood
pressure value has reached a dangerous point.
compared to the hospital? If the cuff is tied properly.
The blood pressure is different even If the cuff is too tight or too loose.
throughout the day due to weather, If the cuff is tied on the upper arm.
Level
Blood Optimal Normal High-normal Mild Moderate Severe If you feel anxious.
Pressure (mm Hg) emotion, exercise etc, Also, there is the
Taking 2-3 deep breaths before
“white coat” effect, which means blood beginning will be better for measuring.
SYS <120 120-129 130-139 140-159 160-179 ≥180
pressure usually increases in clinical Advice: Relax yourself for 4-5
DIA <80 80-84 85-89 90-99 100-109 ≥110 settings. minutes until you calm down.
of ±15%, the irregular heartbeat symbol appears on the display when the measurement different people. We suggest you
results are appear.
measure the same arm every time.
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.
20 21
TROUBLESHOOTING SPECIFICATIONS
This section includes a list of error messages and frequently Battery powered mode:
Power supply
asked questions for problems you may encounter with your blood 6V DC 4*AAA batteries
pressure monitor. If the products not operating as you think it Display mode Digital LCD display V.A.60 mm × 40.5 mm
should, check here before arranging for servicing.
Measurement mode Oscillographic testing mode
PROBLEM SYMPTOM CHECK THIS REMEDY Rated cuff pressure:
0 mmHg ~ 299 mmHg (0 kPa ~ 39.9 kPa)
Batteries are exhausted. Replace with new batteries Measurement range Measurement pressure:
Display
No power SYS: 60 mmHg ~ 230 mmHg (8.0 kPa ~ 30.7 kPa)
will not light up. Batteries are inserted Insert the batteries
correctly
DIA: 40 mmHg ~ 130 mmHg (5.3 kPa ~ 17.3 kPa)
incorrectly.
Pulse value: (40-199) beat/minute
Low Display is dim or Replace with new batteries Pressure: 5°C - 40°C within ±3 mmHg (0.4 kPa)
Battery is low. Accuracy
shows Pulse value: ±5%
battery
Make sure the Phone’s A temperature range of : +5°C to +40°C
E 01 shows Data communication A relative humidity range of 15% to 90%,
Bluetooth and APP is on
has failed. Normal working non-condensing, but not requiring a water
and measure again.
Readjust the cuff and condition vapour partial pressure greater than 50 hPa
E 03 shows The cuff is not secure. An atmospheric pressure range of :
relax for a moment
and then measure again. 700 hPa to 1060 hPa
The monitor detected Movement can affect the Temperature: -20°C to +60°C
motion, talking or the measurement. Relax for a Storage & transportation A relative humidity range of ≤ 93%,
E10 or E11
pluse is too poor moment and then condition non-condensing, at a water vapour pressure up
Error shows
while measuring. measure again. to 50 hPa
message The measurement Loosen the clothing on the Measurement perimeter About 22-42 cm
E20 shows process does not detect arm and then measure of the upper arm
the pulse signal. again Net Weight Approx.182 g (Excluding the dry cells and cuff)
The treatment of the Relax for a moment and
E21 shows
measurement failed. then measure again. External dimensions Approx.110 mm × 110 mm × 41 mm
23
22
EMC GUIDANCE EMC EMC GUIDANCE
GUIDANCE
Table 2
EMC Guidance
Guidance and manufacturer’s declaration – electromagnetic Immunity
The ME EQUIPMENT or ME SYSTEM is suitable for home healthcare environments.
Immunity Test IEC 60601-1-2 Compliance level
Warning: Don’t be near the active HF surgical equipment and the RF shielded room of an ME system for Test level
magnetic resonance imaging, where the intensity of EM disturbances is high.
Warning: Use of this equipment adjacent to or stacked with other equipment should be avoided because it Electrostatic ±8 kV contact ±8 kV contact
could result in improper operation. If such use is necessary, this equipment and the other equipment should be discharge (ESD) ±2 kV, ±4kV, ±8 kV, ±15 kV air
observed to verify that they are operating normally. ±2 kV, ±4kV, ±8 kV, ±15 kV air
IEC 61000-4-2
Warning: Use of accessories, transducers and cables other than those specified or provided by the
manufacturer of this equipment could result in increased electromagnetic emissions or decreased
electromagnetic immunity of this equipment and result in improper operation. Electrical fast Not applicable
Not applicable
transient/burst
Warning: Portable RF communications equipment (including peripherals such as antenna cables and external
antennas) should be used no closer than 30 cm (12 inches) to any part of the equipment TMB-1491-S, IEC 61000-4-4
including cables specified by the manufacturer. Otherwise, degradation of the performance of this equipment
could result.
Surge Not applicable Not applicable
IEC61000-4-5
Technical description:
1,All necessary instructions for maintaining BASIC SAFETY and ESSENTIAL PERFORMANCE with regard to
electromagnetic disturbances for the excepted service life.
Voltage dips, short Not applicable Not applicable
2,Guidance and manufacturer’s declaration -electromagnetic emissions and Immunity. interruptions and
voltage variations
on power supply
Table 1 input lines
IEC 61000-4-11
25
24
EMC GUIDANCE EMCINFORMATION
CONTACT GUIDANCE
Table 3
Contact Information
Guidance and manufacturer’s declaration - electromagnetic Immunity
For more information about the products, please visit www.ptbhaktisamaroartha.com.
Radiated RF Test Band Service Modulation Maximum Distance IEC Compliance You can get customer service, usual problems and customer download, MINAR will
IEC61000-4-3 Frequency (MHz) (m) 60601-1-2 level
Power
Test Level (V/m)
serve you anytime.
(Test (MHz) (W)
specifications (V/m)
for 385 380-390 TETRA Pulse 1.8 0.3 27 27 Production by:
ENCLOSURE 400 modulation
PORT 18 Hz
IMMUNITY to 450 430-470 GMRS 460, FM ± 5k Hz 2 0.3 28 28
RF wireless FRS 460 deviation
communicati- 1 kHz sine
ons
equipment) 710 704-787 LTE Band Pulse 0.2 0.3 9 9
745 13, modulation
17 217 Hz
780
810 800-960 GSM Pulse 2 0.3 28 28
800/900, modulation
870 TETRA 800, 18 Hz
iDEN 820,
930 CDMA 850,
LTE Band 5
1720 1700- GSM 1800; Pulse 2 0.3 28 28
1990 CDMA 1900; modulation
1845 GSM 1900; 217 Hz
DECT;
1970 LTE Band 1,
3, 4,25;
UMTS
2450 2400- Bluetooth, Pulse 2 0.3 28 28
2570 WLAN, modulation
802.11 217 Hz
b/g/n, RFID
2450, LTE
Band 7
5240 5100- WLAN Pulse 0.2 0.3 9 9
5800 802.11 modulation
5500 a/n 217 Hz
5785
26 27