Pic Solution helpRAPID, Instructions For Use Manual

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Soft Cuff Fig. D Fig. E
Automatic Blood pressure monitor
THESE INSTRUCTIONS ARE IMPORTANT. PLEASE KEEP THEM FOR FUTURE REFERENCE.
Dear customer,
Thank you for choosing Pic Solutions helpRAPID, 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 in-
formation 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 armband inflation phase. Pic helpRAPID 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
List of included items: Monitor, Pic Ready Cuff M-L size ( 02007832000000), 4xAAA batteries, User manuals, Carring bag.
Features:
• 128x50mm Blue LCD display with White backlight
• Touch sensor keys
• Two memory areas
• 100 recorded measurement per area
• Inflation-type measurement
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:
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.
WARNING
Only a physician can tell your normal BP range. Please
contact a physician if your measuring result 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 de-
tected when a heartbeat rhythm varies while the unit is measur-
ing the systolic and diastolic blood pressure. During each meas-
urement, 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 inter vals, 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.
Is the result 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.
SYMBOL DESCRIPTION EXPLANATION
Systolic pressure Maximum/systolic pressure result
Diastolic pressure Minimum/diastolic pressure result
Pulse Pulse/minute
Deflating The arm cuff is deflating
Clock (hours: minutes) Currently time
Memory If “M” shows that displayed measurement values is from the memory.
mmHg Blood pressure unit of measurement mmHg
Low battery Batteries are low and need to be replaced
Motion detected while measuring Shocking will result in inaccurate
Average The average of last 3 measurements taken within 30 minutes.
Recalling The records will be showed
Irregular heartbeat Irregular heartbeat
Memory area A The Area A is chosen
Memory area B The Area B is chosen
Grade Blood pressure level indicator
Date “M” shows the month, “D” shows the day
Heartbeat Heartbeat detection during the measurement
STAR T
STOP
SET
MEM
A
A
No rm al
Pul
/min mmHg
DIA
mmHg
SYS B
The Choice of Power Supply
1. Battery powered mode: 4 batteries 1,5V AAA; 6V
2. Power supply via mains adapter: Input: 100 - 240V~, 50 / 60Hz, 0.2A max, Output: 6V 1A
Can be powered only with the “Adapter for blood pressure monitor” 02000520000000
(BLJ06L060100P-V) with European plug and the “Adapter for blood pressure monitor UK”
02010310000000 (BLJ06L060100P-B) with UK plug (Not included).
Please unplug the adapter to depart from the using utility power.
NB: The adapter connector is located on the right side of the monitor. Place NO obstacles on the
right side for easy pull-off adapter.
WARNING
In order to protect your device and yourself and to get the best performances, use only the batteries and adapter
according 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.
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/EC).
• 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: 2015-2055, 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.
Wear the cuff
Plug in the cuff connecting tube into the unit. Wrap the arm cuff and follow these steps:
1. Use your right hand to open the cuff (Fig. A).
2. Place the cuff on your left arm by using the red band as a reference (Fig. B).
3. 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 (Fig. C).
4. 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, so the cuff is at the same height as your heart. Make sure the tube is not kinked and the edge of the cuff is not folded.
Note: If you use the soft cuff
02007827000000 not included, please refer to Fig. D, E and C, instead of Fig. A, B and C.
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 approxi-
mately the same time, on the same arm, or as directed by a physician.
Start the Measurement
1.
When the monitor is off, select User A or User B, press the to turn on the monitor and start the measurement.
LCD display. Zero setting. Inflating and measuring. Display and 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, select area A or area B and
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.
The symbol of “AVG” will show in the right corner
2.
Press “MEM” or “SET” to see the recording wanted.
Date and time will display alternately.
WARNING
The most recent recording (0) is shown first. Every time a new
recording is made, the first (0) 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 (99/99) 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. When the blood pressure monitor is in memory mode, select area A or area B and keep the “MEM” button pressed for 3 seconds;
the display blinks. 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
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
maintain 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 stran-
gulation 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 medi-
cation 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 measurements 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 measurement.
• To avoid measurement errors, please avoid the condition of strong electromagnetic field radiated interference signal or
electrical 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.
• 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 the limb concerned) that operation of helpRAPID 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, as this 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 REMEDY
No power
Display will not
light up.
Batteries are exhausted. Replace with new batteries
Batteries are inserted incorrectly. Insert the batteries correctly
AC adaptor is inserted incorrectly. Insert the AC adaptor correctly
Low
batteries
The display is dim
or shows
Batteries are exhausted. Replace with new batteries
Error
message
E 1 shows The cuff is not secure Refasten the cuff and then measure again.
E 2 shows The cuff is very tight Refasten the cuff and then measure again.
E 3 shows The pressure of the cuff is excess. Relax for a moment and then measure again.
E10 or E11 shows
The monitor detected motion while
measuring.
Movement can affect the measurement. Relax
for a moment and then measure again.
E20 shows
The measurement process does not
detect the pulse signal.
Loosen the clothing on the arm and then
measure again
E21 shows
The treatment of the measurement
failed.
Relax for a moment and then measure again.
EExx, shows on the
display.
A calibration error occurred.
Retake the measurement. If the problem
persists, contact the dealer or our customer
service department for further assistance.
Refer to the warranty for contact information
and return instructions.
OUT Out of range measurement.
Relax for a moment. Refasten the cuff and
then measure again. If the problem persists,
contact your Physician.
SPECIFICATIONS
• Power supply:
Battery powered mode: 4 batteries 1,5V AAA; 6V (~ 225 measurements)
Power supply via mains adapter: Input: 100 - 240V~, 50 / 60Hz, 0,2A max, Output: 6V 1A
Can be powered only with the “Adapter for blood pressure monitor” 02000520000000
(BLJ06L060100P-V) with European plug and the “Adapter for blood pressure monitor UK”
02010310000000 (BLJ06L060100P-B) with UK plug (Not included).
• Display:
Blue LCD with white backlight, V.A.128x50 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: 40–199 beat/minute
• Accuracy:
Pressure: ± 3mmHg (5°C to 40°C)
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. 270 g (Excluding the batteries)
• External dimensions:
Approx.100 × 186 × 35mm
• Accessories:
Not included: Adaptor 02000520000000 with European plug - 02010310000000
with UK plug and soft cuff 02007827000000 (size M-L)
Included: Pic Ready cuff 02007832000000 (size M-L)
• Mode of operation:
Continuous operation
• Useful life:
10,000 Measurements
• Degree of protection:
Type BF applied part (cuff )
• Protection against
ingress of water:
IP 21
Protected against solid foreing objects of 12.5mm Ø and greater and protected against
vertically falling water drops.
• Software version:
A01
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 helpRAPID ( 02022527000100) is intended for use in the electromagnetic environment specified below. The
customer or the user of the helpRAPID ( 02022527000100) should assure that it is used in such an environment.
Emissions test Compliance Electromagnetic environment - guidance
RF emissions
CISPR 11
Group 1
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.
RF emissions
CISPR 11
Class [B]
The helpRAPID ( 02022527000100) 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 dome-
stic purposes.
Harmonic emissions
IEC 61000-3-2
Class A
Voltage fluctuations/
flicker emissions
IEC 61000-3-3
Complies
Guidance and manufacturer’s declaration - electromagnetic Immunity
The helpRAPID ( 02022527000100) is intended for use in the electromagnetic environment specified below. The
customer or the user of the helpRAPID ( 02022527000100) should assure that it is used in such an environment.
Immunity Test IEC 60601 Test level Compliance level Electromagnetic environment -
guidance
Electrostatic
discharge (ESD)
IEC 61000-4-2
±8 kV contact
±15 kV air
±8 kV contact
±15 kV air
Floors should be wood, concrete or cera-
mic tile. If floors are covered with synthetic
material, the relative humidity should be at
least 30%.
Electrical fast
transient/burst
IEC 61000-4-4
Power supply lines: ±2 kV
Input/output lines: ±1 kV
Power supply lines:
±2 kV
Mains power quality should be that of a
typical commercial or hospital environ-
ment.
Surge
IEC 61000-4-5
line(s) to line(s): ±1 kV
line(s) to earth: ±2 kV
100 kHz repetition
frequency
line(s) to line(s): ±1 kV
100 kHz repetition
frequency
Mains power quality should be that of a
typical commercial or hospital environ-
ment.
Voltage dips, short
interruptions and
voltage variations on
power supply input
lines IEC 61000-4-11
0%U
T
; 0.5 cycle
At 0°, 45°, 90°, 135°,
180°,225°,270° and 315°
0%U
T
; 1 cycle
and
70%U
T
; 25/30 cycles
Single phase: at 0°
0% U
T
; 300 cycle
0% U
T
; 0.5 cycle
At 0°, 45°, 90°, 135°,
180°,225°,270° and 315°
0% U
T
; 1 cycle
and
70% U
T
; 25/30 cycles
Single phase: at 0°
0% U
T
; 300 cycle
Mains power quality should be that of a
typical commercial or hospital environ-
ment.
Power frequency
(50/60Hz) magnetic
field IEC 61000-4-8
30 A/m
50Hz/60Hz
30 A/m
50Hz/60Hz
Power frequency magnetic fields should
be at levels characteristic of a typical lo-
cation in a typical commercial or hospital
environment.
NOTE U
T
is the a.c. mains voltage prior to application of the test level.
START
STOP
SET
MEM
A
A
Pul
/min
mmHg
DIA
mmHg
SYS
B
Backlighted LCD
Mains adapter
connector
BLOOD PRESSURE
GRADE INDICATOR:
Cuff connector
Cuff
Memory Key
User selection switch
START/STOP Key
Setting Key
help
RAPID
M100% + Y100% P 485 C
P 281 C
The current memory
record is No. 2. Eight
records in total.
The corresponding
date is 11th October
The corresponding
time is 10:38.
INSTRUCTIONS FOR USE
PLEASE REFER TO THE INSTRUCTIONS FOR USE
Normal High
Hypertension
Normal Blood Pressure
Pic Ready Cuff Fig. A Fig. B
Main artery
Cuff tube
2-3cm (0.8”-1.2”)
Fig. C