Pic Solution easyRAPID Mode D'emploi

easy
EN
RAPID
Automatic Blood pressure monitor
INSTRUCTIONS FOR USE
PLEASE REFER TO THE INSTRUCTIONS FOR USE
THESE INSTRUCTIONS ARE IMPORTANT. PLEASE KEEP THEM FOR FUTURE REFERENCE.
Dear customer,
Thank you for choosing Pic Solutions easyRAPID, an automatic blood pressure monitor designed and manufactured according
the most up-to-date technologies. Before using the device, we highly recommend that you read the short list of warnings
contained in this manual, to make sure you have correctly understood how to use it.
INTRODUCTION
The regular use of a Blood Pressure Monitor allows you to monitor blood pressure continuously, but it should not take the
place of regular check-ups by your doctor. We recommend that you visit your doctor regularly for general check-ups and for
more detailed information on blood pressure. Blood pressure measurements determined with this unit are equivalent to those
obtained by a trained observer using cuff/ stethoscope auscultation method, within the limits prescribed by the international
ESH Validation protocol.
WARRANTY
The product is guaranteed for 5 years against all conformity defects under the normal utilisation conditions provided in the user instruc-
tions. Therefore, the warranty shall not apply in case of damages caused by improper use, wear, or accidental events. Batteries, cuff and
wearing parts are not included in the warranty. In case of malfunction, contact exclusively the authorised Pic Technical Customer Service.
RAPID-TECH Comfort Experience TM
This unit uses the oscillometric method to detect your blood pressure. RAPID-TECH Comfort Experience TM is the latest generation
technology chosen by Pic for the blood pressure monitors of the line RAPID. It allows fast and, therefore, less annoying monitoring
because the measurement is performed already during the cuff inflation phase. Pic easyRAPID has been clinically validated in
accordance with the ESH (European Society of Hypertension) protocol, as a guarantee of its accuracy and precision.
NAME/FUNCTION OF EACH PART
Memory Key
Blood pressure range Setting Key
START/STOP Key
Mains adapter
connector
Cuff connector
List of included items: Blood pressure monitor , M-L size cuff ( 02007827000000), 4xAAA batteries, user manuals, carring bag.
Features: 60×41 mm LCD display, 60 recorded measurements, Inflation-type measurement.
ABOUT BLOOD PRESSURE
What is blood pressure?
Blood pressure is the pressure exerted on the artery tube while blood flows through the arteries. The pressure measured when
the heart contracts and sends blood out of the heart is systolic (highest) blood pressure. The pressure measured when the heart
dilates with blood flowing back into the heart is called diastolic (lowest) blood pressure.
Why measure your blood pressure?
Among the various health problems afflicting modern people, problems associated with high blood pressure are by far the
most common. High blood pressure's dangerously strong correlation with cardiovascular diseases and high morbidity has
made measuring blood pressures a necessity of identifying those at risk.
Blood Pressure Fluctuation
Blood pressure fluctuates all the time! You should not be over worried if you encountered two or three measurements at high levels.
Blood pressure changes over the month and even throughout the day. It is also influenced by the season, temperature and activities.
Classification of high blood pressure
The out-of-office blood pressure classification published by ESH/ESC in 2013 is as follows:
Hypertension
Note: It is not intended to provide a basis of any type of rush
toward emergency conditions/diagnosis based on the scheme:
the scheme is meant only to discriminate between the different
levels of blood pressure.
Normal Blood Pressure
Systolic blood pressure (mmHg)
WARNING
Only a physician can tell your normal BP range. Please contact a physician if the average of your measuring results falls out
of the range. Kindly note that only a physician could tell whether your blood pressure value has reached a dangerous point.
Irregular Heartbeat Detector
This blood pressure monitor is equipped with an algorithm for Irregular Heartbeat (IHB) Detection. An irregular heartbeat is
detected when a heartbeat rhythm varies 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%, then the irregular
heartbeat symbol will appear on the display with the measurement result.
WARNING
The appearance of the IHB icon indicates that a pulse irregularity consistent with an irregular heartbeat was detected
during measurement. Usually this is NOT a cause for concern. However, if the symbol appears often, we recommend
you seek medical advice. We wish to underline that the device does not replace a visit to the cardiologist, but it is useful to
detect any irregularities in advance.
Why the blood pressure I get from the hospital is different from home?
The blood pressure is different even during 24 hour because of the weather, emotion, exercise etc, specially the "white coat" in
hospital which makes the results are higher than the ones at home.
If the result is the same if measuring on the right arm?
Measurements can be taken on either arm; results can however differ sometimes so it is always advisable to use the same arm.
LCD display explanation
At starting check the completeness of the LCD segments.
BLOOD PRESSURE GRADE INDICATOR
HIGH
NORMAL
P 281 C
SYMBOL DESCRIPTION EXPLANATION
Systolic pressure Maximum/systolic pressure result
Diastolic pressure Minimum/diastolic pressure result
Pulse Pulse/minute
Deflating The arm cuff is deflating
Memory If "M" shows, the displayed measurement values is from the memory
mmHg Blood pressure unit of measurement mmHg
Low battery Batteries are low and need to be replaced
Irregular heartbeat Irregular heartbeat
Grade Blood pressure level indicator
Date "MM" shows the month, "DD" shows the day
Average The average of last 3 measurements taken within 30 minutes.
The Choice of Power Supply
1. Battery powered mode: 4 batteries 1,5V AAA; 6 V DC.
2. Power supply via mains adapter: Input: 100-240V~, 50-60Hz, 0.2A max - Output: 6V
Can be powered only with the "Adapter for blood pressure monitor" 02000520000000 model BLJ06L060100P-V with European
plug and the "Adapter for blood pressure monitor UK" 02010310000000 model BLJ06L060100P-B with UK plug (not included).
Please unplug the adaptor to depart from the using utility power.
NB: The adaptor interface is located on the right side of the monitor. Place NO obstacles on the right side for easy pull-off adaptor.
WARNING
In order to protect your device and yourself and to get the best performances, use only the batteries and adaptors accord-
ing to the information provided in this manual (4 batteries 1,5V AAA; 6 V DC).
Installing and Replacing the Batteries
1. Slide off the battery cover.
2. Install the batteries by matching the correct polarity, as shown by the marks inside the battery compartment.
3. Replace the cover.
Replace the batteries whenever the below happen
Is displayed , the display dims, the display does not light up
WARNING
• If the device is not used for a while, please remove the batteries.
• The old battery is harmful to the environment, so please disposal accordingly to the indication reported in this user
manual (EU Directive 2006/66 CE).
• Do not dispose of batteries in fire. Batteries may explode or leak.
• For instructions on battery disposal please refer to the indication reported in this user manual.
• There are no user serviceable parts inside. Batteries or damage from old batteries is not covered by warranty.
• Only use brand batteries. Always replace with new batteries together. Use batteries of the same brand and same type. Other
types of batteries can cause explosions or fires.
• The battery can explode if handled carelessly. Never recharge, remove or position the batteries near sources of heat. Do not incinerate.
• Rechargeable batteries are not recommended.
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 meas-
urement that is stored in the memory. (year: 2015—2050, time: 12H/24H). In the setting mode, use the "MEM" button to change
the value and the "SET" button to confirm your choice.
1. When the unit is off, hold pressing "SET" for 3 seconds to enter the mode for year setting.
2. Press the "MEM" to change the [YEAR].
3. When you get the right year, press "SET" to set down and turn to next step.
4. Repeat step 2 and 3 to set the [MONTH] and [DAY].
5. Then it will enter time setting mode. There are two kinds of time format "12" hours and "24 " hours. Press "MEM" button to
change the time format. Press "SET" button to confirm the time format.
6. Repeat step 2 and 3 to set the [HOUR] and [MINUTE].
7. After confirming the time, the LCD will display "dOnE" and the monitor will shut off.
Tie the Cuff
1. Plug in the cuff connecting tube into the unit.
2. Wrap the arm cuff, leaving the end of the cuff around the cuff.
2-3 cm
(0.8" - 1.2")
3. Insert arm in the cuff. The tube must be aimed in the direction of the hand. Turn the palm of the hand upward and rest the
edge of the cuff at about 2-3 cm (0.8" - 1.2") over the hollow of the elbow. Tighten the cuff by pulling the end.
4. Press the hook and loop material together securely. Allow room for 2 fingers to fit between the cuff and your arm. Position
the artery mark over the main artery (on the inside of your arm). Note: Locate the main artery by pressing with 2 fingers
approximately 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.
5. Lay your arm on a table (palm upward) so the cuff is at the same height as your heart. Make sure the tube is not kinked.
Helpful Tips
Here are a few helpful tips to help you obtain more accurate readings:
• Do not measure your blood pressure immediately after consuming a large meal.
• To obtain more accurate readings, please wait one hour after meal before measuring.
• Do not smoke or drink tea, coffee or alcohol before measuring your blood pressure.
• Do not measure your blood pressure immediately after taking a bath: wait at least 20 minutes.
• You should not be physically tired or exhausted while taking a measurement.
• Do not measure your blood pressure when you want to discharge urine.
• It is important that you relax during measurement.
• Do not take measurements if you are under stress or tense.
• Take your blood pressure at normal body temperature. If you are feeling cold or hot, wait a while before taking a measurement.
• Rest for 5 minutes before measuring.
• Wait at least 3 minutes between measurements. This allows your blood circulation to recover.
• Take the measurement in a silent room.
• Do not move and do not talk when taking a measurement
• Do not cross your legs and keep your feet 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 the to turn on the monitor and start the measurement.
Zero
Inflating and
Display and
LCD display.
self-adjustment. measuring.
save the results.
2. Press the to power off, otherwise it will turn off within 1 minute.
If the icon appears, please, read carefully the Helpful Tips section and repeat the measurement.
Notes: To stop the measurement at any time, press the START/STOP button. The cuff will quickly deflate
Store the cuff carefully.
Recall the measurements
1. When the Blood pressure monitor is off, press the "MEM" button to see the average of the last 3 recordings taken withn 30 minutes. If the
recorded measurements are less than 3 as well as the last 3 recordings are taken in more than 30 minutes,you will see the latest reading.
2. Press "MEM" or "SET" to see the recording wanted.
Date and time will display alternately.
It means the The corresponding date is
current is the No 2. 1st January.
WARNING
The most recent recording (1) is shown first. Every time a new recording is made, the first (1) record is assigned to it. All
the others are moved by one figure (e.g. 2 becomes 3, and so on), whereas the last record (60) is deleted from the list.
Delete the measurements
If you did not get the correct measurement, you can delete all results by following below steps.
1. Hold pressing "MEM" for 3 seconds when the monitor is in the memory recall mode , the display will show "del All". Press "SET"
to confirm deleting and the monitor will turn off.
2. If you don't want to delete the records, press "START/STOP" to escape.
3. If there is no record the display will show "- -".
Maintenance
1A
In order to get the best performance from your monitor, please follow the below instructions.
• Put in a dry place and avoid the sunshine.
• Avoid touching water, clean it with a dry cloth in case.
• Avoid the intense shaking and collision.
• Avoid the dusty and unstable temperature environment.
• Using the wet clothing to remove the dirt.
• Avoid washing the cuff.
Calibration and service
• The accuracy of this monitor has been carefully tested and is has been designed for a long life. Indeed the monitor can main-
tain the safety and performance characteristics for a minimum of 10,000 measurements or five years of normal use.
• It is generally recommended to check the unit every two years to ensure correct functioning and accuracy. Please consult the
Contact information in this user manual to get in touch with your local authorized Service Center.
WARNINGS
• This device is intended for no-invasive measuring and monitoring of arterial blood pressure on adults, in home and
professional environment.
• This device is not suitable for use on newborns, children or pregnant women. The device is not validated to be used on the
above listed patient and it could be dangerous. The use on teenagers shall be evaluated by physician.
• The device cannot be used on pre-eclamptic female.
• The device is not suitable for use if your arm circumference is not included in the range 22cm-42cm (8¾'' - 16½'').
• People with reduced cognitive abilities shall use the device under supervision.
• Keep out of reach of children, people with reduced cognitive abilities or pets: the device contains small parts which can cause
suffocation or internal lesions if swallowed. The cuff tubes and the cable of AC/DC adapter (optional) can create strangulation
risk.
• If the arm cuff pressure reaches 300 mmHg it deflate automatically. If the arm cuff does not deflate when pressure reaches
300 mmHg or if you feel discomfort during the measurement take it off your arm and press the START/STOP button to stop
inflation.
• Do not confuse self-monitoring with self-diagnosis. By using this device you can monitor your blood pressure, but it does not
replace your doctor. Begin or end medical treatment based solely on medical advice. If you are taking medication, consult your
physician to determine the most appropriate time to measure your blood pressure. Never change a prescribed medication
without consulting your Physician
• If Irregular Heartbeat (IHB) brought by common arrhythmias is detected in the procedure of blood pressure measurement, a
signal of will be displayed. Under this condition, the Electronic Sphygmomanometer can keep function, but the results may
not be accurate, it's suggested that you consult with your physician for accurate assessment. When the device is used for meas-
urements on patients with common arrhythmias, such as atrial or ventricular premature beats or atrial fibrillation, a deviation
may occur. Please consult your doctor about the result.
• Please consult your physician before using the device if you have active implanted medical devices.
• This unit is not suitable for continuous monitoring during medical emergencies or operations.
• This device cannot be used with HF surgical equipment at the same time.
• This device is not intended to be used during patient transportation outside a healthcare facility.
• It is not intended for use on extremities other than the arm or for functions other than obtaining a blood pressure measure-
ment.
• To avoid measurement errors, please avoid the condition of strong electromagnetic field radiated interference signal or elec-
trical fast transient/burst signal.
• The user must check that the equipment functions safely and see that it is in proper working condition before being used.
Cuff tube • Manufacturer will make available on request circuit diagrams, component parts list etc. only to qualified person.
• Too frequent measurements can cause injury to the PATIENT due to blood flow interference. Please check (by observation of
Main artery
the limb concerned) that operation of easyRAPID does not result in prolonged impairment of the circulation of the blood of
the PATIENT.
• This unit is not suitable for continuous monitoring during medical emergencies or operations. Otherwise, the patient's arm
and fingers will become anaesthetic, swollen and even purple due to a lack of blood.
• Check that the device tubes are not kinked while using the device: kinked tubes can generate lack of blood in the extremities.
• Please use the device under the environment which was provided in the instruction manual. If this is not complied with,
correct operation and life of the device may be compromised.
• During using, the patient will 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 irritation reaction.
• The application of the CUFF over a wound can cause further injury.
• The application of the CUFF and its pressurization on any limb where intravascular access or therapy, or an arterio-venous (A-V)
shunt, is present because of temporary interference to blood flow and could result in injury to the PATIENT
• The application of the CUFF and its pressurization on the arm on the side of a mastectomy can cause injury or give not
accurate measurement.
• Do not inflate the cuff on the same limb which other monitoring ME equipment is applied around simultaneously, because
this could cause temporary loss of function of the simultaneously-used monitoring ME equipment.
• The device is a non-AP/APG device and not suitable for use in the presence of anaesthetic mixtures that are inflammable with
air, oxygen or nitrous oxide.
• The operator shall not touch DC output jack of AC/DC adapter and the patient simultaneously.•
• Please use accessories and detachable parts specified/authorized by the manufacturer. Otherwise, it may cause damage to
the unit or danger to the user/patients.
• We recommend checking its performance every two years or after it has been repaired. The device must be checked again
in case of damage due to impact (such as falls) or exposure to liquids and/or extreme temperatures (hot/cold) or extreme
humidity variations.
• For public place use, please contact your local distributor or the Italian toll-free number 800 900 080 to get support how to
proceed.
• Please dispose of accessories, detachable parts, and the ME EQUIPMENT according to the local guidelines.
• In case of problems concerning performances, settings, maintenance or use of the device, contact your local distributor or the
Italian toll-free number 800 900 080. Warning! Do not service and/or repair the appliance while it is being used! Any mainte-
nance/service activity/operation must be done solely by a PiC Service Centre. No modification of the equipment are allowed.
• When the device is stored at the minimum/maximum storage temperature It takes 4h to warm/cool until the device is ready
for its intended use.
This section includes a list of error messages and frequently asked questions for problems you may encounter with your
sphygmomanometer. If the products not operating as you think it should, check here before arranging for servicing.
PROBLEM SYMPTOM CHECK THIS
Batteries are exhausted.
Display will not
No power Batteries are inserted incorrectly.
light up.
AC adaptor is inserted incorrectly.
Low The display is dim or
Batteries are exhausted.
batteries shows
E 1 shows The cuff is not secure
E 2 shows The cuff is very tight
E 3 shows The pressure of the cuff is excess.
The monitor detected motion
Error
E10 or E11 shows
while measuring.
message
The measurement process does
E20 shows
not detect the pulse signal.
The treatment of the measure-
E21 shows
ment failed.
EExx, shows on the
A calibration error occurred.
display.
Error
message
OUT Out of range measurement.
SPECIFICATIONS
• Power supply: Battery powered mode: 4 batteries 1,5V AAA; 6C DC (~315 measurements). Power supply via main adapter: Input:
The corresponding time 100-240V~50/60 Hz 0,2A max OUTPUT 6V
is 10:08. monitor" 02000520000000 model BLJ06L060100P-V with European plug and the "Adapter for blood pressure
monitor UK" 02010310000000 model BLJ06L060100P-B with UK plug (not included)
• Display: LCD, V.A. 60×41 mm
• Measurement mode: Oscillometric inflation -type measurement mode
• Measurement range: Rated cuff pressure: 0mmHg~299mmHg
Measurement pressure: SYS: 60-230mmHg, DIA: 40-130mmHg
Pulse value: beat/minute
40-199
• Accuracy: Pressure: (5°C-40°C) ± 3mmHg
Pulse value: ±5%
• Normal working
condition:
Temperatures: from 5°C to 40°C Relative humidity 85%
Atmospheric pressure: 86kPa to 106kPa
• Storage & transportation
condition: Temperatures: from -5°C to 50°C Relative humidity 85%
Atmospheric Pressure: 50-106 kPa
• Arm circumference: About 22cm~42cm
• Net Weight: Approx. 200 g (Excluding the dry cells)
• External dimensions: Approx.110×110×41.5mm
• Accessories: Adaptor 02000520000000 with European plug -
Cuff 02007827000000
• Mode of operation: Continuous operation
• Useful life: 10,000 Measurements
• Degree of protection: Type BF applied part (cuff )
• Protection against
ingress of water: IP21 degree of protected against solid foreign objects of 12.5mm Ø and greater and protected
against vertically falling water drops
• Software version:
A00
Contact Information
For further information on our products, please visit the website www.picsolution.com. Here you can find customer service,
solve ordinary problems.
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 electromagnetic 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.
Guidance and manufacturer's declaration – electromagnetic emissions
The EasyRAPID ( 02022525000100) 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.
Emissions test Compliance
RF emissions
Group 1
CISPR 11
RF emissions
Class [B]
CISPR 11
Harmonic emissions
Class A
IEC 61000-3-2
Voltage fluctuations/
flicker emissions Complies
IEC 61000-3-3
Guidance and manufacturer's declaration - electromagnetic Immunity
The EasyRAPID ( 02022525000100) is intended for use in the electromagnetic environment specified below. The
customer or the user of the EasyRAPID ( 02022525000100) should assure that it is used in such an environment.
Immunity Test IEC 60601 Test level
Electrostatic
±8 kV contact
discharge (ESD)
±15 kV air
IEC 61000-4-2
Electrical fast
Power supply lines: ±2 kV
transient/burst
Input/output lines: ±1 kV
IEC 61000-4-4
line(s) to line(s): ±1 kV
Surge line(s) to earth: ±2 kV
IEC 61000-4-5 100 kHz repetition
frequency
0%U ; 0.5 cycle
T
At 0°, 45°, 90°, 135°,
Voltage dips, short
180°,225°,270° and 315°
interruptions and
0%U ; 1 cycle
voltage variations on T
and
power supply input
70%U ; 25/30 cycles
lines IEC 61000-4-11 T
Single phase: at 0°
0% U ; 300 cycle
T
Power frequency
30 A/m
(50/60Hz) magnetic
50Hz/60Hz
field IEC 61000-4-8
REMEDY
Replace with new batteries
NOTE U is the a.c. mains voltage prior to application of the test level.
T
Insert the batteries correctly
Guidance and manufacturer's declaration - electromagnetic immunity
Insert the AC adaptor correctly
The EasyRAPID ( 02022525000100) is intended for use in the electromagnetic environment specified below. The
Replace with new batteries
customer or the user of the EasyRAPID ( 02022525000100) should assure that it is used in such an environment.
Refasten the cuff and then measure again.
Immunity Test IEC 60601 Test level
Refasten the cuff and then measure again.
Relax for a moment and then measure again.
Movement can affect the measurement. Relax
150 kHz to 80 MHz:
for a moment and then measure again.
3Vrms
Conducted RF
Loosen the clothing on the arm and then 6Vrms (in ISM and
IEC 61000-4-6
amateur radio bands)
measure again
80% Am at 1kHz
Relax for a moment and then measure again.
Retake the measurement. If the problem persists,
contact the dealer or our customer service depart-
ment for further assistance. Refer to the warranty
for contact information and return instructions.
Relax for a moment. Refasten the cuff and then meas-
ure again. If the problem persists, contact your Physician.
1000mA. Can be powered only with the "Adapter for blood pressure
02010310000000 with UK plug and
Electromagnetic environment - guidance
The device uses RF energy only for its internal function.
Therefore, its RF emissions are very low and are not likely
to cause any interference in nearby electronic equipment.
The EasyRAPID ( 02022525000100) is suitable for
use in all establishments, other than domestic and tho-
se directly connected to the public low-voltage power
supply network that supplies buildings used for domestic
purposes.
Compliance level Electromagnetic environment -
guidance
Floors should be wood, concrete or cera-
±8 kV contact mic tile. If floors are covered with synthetic
±15 kV air material, the relative humidity should be at
least 30%.
Power supply lines: Mains power quality should be that of a
±2 kV typical commercial or hospital environment.
line(s) to line(s): ±1 kV
Mains power quality should be that of a
100 kHz repetition
typical commercial or hospital environment.
frequency
0% U ; 0.5 cycle
T
At 0°, 45°, 90°, 135°,
180°,225°,270° and 315°
0% U ; 1 cycle Mains power quality should be that of a
T
and typical commercial or hospital environment.
70% U ; 25/30 cycles
T
Single phase: at 0°
0% U ; 300 cycle
T
Power frequency magnetic fields should be
30 A/m at levels characteristic of a typical location
50Hz/60Hz in a typical commercial or hospital envi-
ronment.
Compliance level Electromagnetic environment -
guidance
Portable and mobile RF communications
equipment should be used no closer to any
part of the device, including cables, than the
150 kHz to 80 MHz:
recommended separation distance calcula-
3Vrms
ted from the equation appropriate for the
6Vrms (in ISM and
frequency of the transmitter.
amateur radio bands)
Recommended separation distances:
80% Am at 1kHz
d = 0.35 √P
d = 1.2 √P