Pic Solution CARDIOAfib Mode D'emploi

Afib
EN CARDIO
Automatic Blood pressure monitor
INSTRUCTIONS FOR USE
WARNING! PLEASE REFER TO THE INSTRUCTIONS FOR USE
PLEASE READ THIS MANUAL CAREFULLY BEFORE USE.
CAUTION! THESE INSTRUCTION ARE IMPORTANT, KEEP THEM FOR FUTURE REFERENCE
Dear customer,
Thank you for choosing Pic Solutions CARDIOAfib, an automatic blood pressure monitor designed and manufactured accord-
ing the most up-to-date technologies. Before using the device, we highly recommend that you read the short list of warnings
contained in this instructions for use manual, to make sure you have correctly understood how to use it. If you have any doubts
on the contents of this instruction manual, please contact your retailer or PIKDARE S.p.A..
WARNING! This unit is to be used only by adult consumers. Do not use this device on infants or neonates.
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 trai-
ned 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 instructions. Therefore, the warranty shall not apply in case of damages caused by improper use, wear, or accidental even-
ts. Batteries, cuff and wearing parts are not included in the warranty. In case of malfunction, contact exclusively the authorised
Pic Technical Customer Service.
PIC PULSE DETECTOR
Pic Pulse detector specifically detects the existence of pulse arrhythmia, including atrial fibrillation (AF, AFib), Atrial and / or
Ventricular Premature Contractions (PC). Pulse Arrhythmia may be related to cardiac disorders, needs medical attention and
thus early diagnosis is of paramount importance. The Pic Pulse detector detects arrhythmia during regular blood pressure
checks without any additional user skills, user interaction and measurement prolongation. Beside the blood pressure diagnosis
a specific pulse arrhythmia diagnosis is provided with Pic Pulse detector.
Note: The detection of AFib and PC is provided with a clinically proven high detection probability [1]. However, the sensitivity and
specificity is limited, thus most, but not all pulse arrhythmia will be detected and displayed. In certain patients with uncommon
clinical conditions the Pic Pulse detector may not be able to detect pulse arrhythmia. This partly comes from the fact that some
arrhythmia can only be found with an ECG diagnosis, but not with a pulse diagnosis. Thus the Pic Pulse detector is not meant
to replace any medical ECG diagnosis by your doctor. provides an early detection of certain pulse arrhythmia, which inevitably
need to be presented to your doctor in charge.
Remark: [1] Clinical Investigation of the Pic Pulse detector used in this device- A new Oscillometric Pulse Arrhythmia Type
Discriminating Detection Technology.
ATRIAL FIBRILLATION DETECTION (AFib)
The upper chambers of the heart (the atria) do not contract, but quiver and thus blood is driven irregularly and with lower
efficiency into the ventricles. Subsequently irregular heartbeats occurs, which mostly are associated with a fast, yet highly
instable heart rate. This condition is associated with a higher risk for the formation of cardiac blood clots. Amongst others,
they may elevate the risk of brain strokes. Beside this atrial fibrillation may contribute to the severity of a chronic or acute
heart failure condition and may be associated with other heart-related complications. Age dependent, about 10 % - 20 %
percent of patients who suffer from an ischemic stroke also suffer from atrial fibrillation. Atrial fibrillation most often initially
occurs with temporary periods of arrhythmia and may progress to a permanent state of this disorder in the course of time. No
matter, whether you intent to safeguard yourself from an undetected AFib state, or you measure during an ongoing period
of active atrial fibrillation, or you measure in between periods of AFib, the the Pic Pulse detector can be applied at any of
these conditions. This unit is able to detect Atrial fibrillation (AFib). The ARR and AFib icons ( ) are displayed right after the
measurement if Atrial Fibrillation was detected. Note: It is strongly recommended, that you consult your physician, if either the
AFib icon occurs newly for several times, or, if your AFib is known to your doctor, but the incidence of AFib readings changes
over time. Your doctor will then be able to provide all required medical test and possible therapeutic procedures. Note: The
presence of a cardiac pacemaker may impair the AFib detection by the Pic Pulse detector.
PREMATURE CONTRACTION DETECTION (PC)
Extra abnormal heartbeats generated in irregular excitation sites of your heart, either in the atria (PAC), the ventricle (PVC) or
the cardiac conduction nodes (PNC). These extra beats may disrupt your regular rhythm, they may come in early or cause a
significant pauses regarding your perceivable pulse. This is called palpitations, which can be felt in your chest. They may occur
as isolated, single events, as a series of irregular pulses or can be distributed all over your pulse beats. If they are not related to
mental stress, or acute demanding physical load, they may be a marker for a multitude of cardiac disorders. Some of these di-
sorders go along with an elevated risk profile for ischemic events, either in the heart (e,g, coronary heart disease) or outside the
heart, e.g. an elevated risk for a stroke. Some PCs may indicate on valvular or myocardial disorders and become very important
if a myocarditis (infection of the heart muscle) is suspected. This unit is able to detect premature contractions (
and PC icons are displayed right after the measurement if premature contractions have been detected.
Note:It is strongly recommended, that you consult your physician, if either the PC icon occurs newly for several times, or, if your
PC is known to your doctor, but the incidence of PC readings changes over time. Your doctor will then be able to provide all
required medical test and possible therapeutic procedures.
PULSE ARRHYTHMIA DETECTION (ARR)
Once the occurrence of pulse arrhythmia has been detected in the course of your blood pressure measurement, the icon ARR is
displayed. In the case, that the found pulse arrhythmia can be specified by the Pic Pulse detector, the ARR icon is accompanied
by the specifically detected type of arrhythmia, e.g. PC or AFib. Once the kind of found pulse arrhythmia cannot be safely determi-
ned by this technology, the device is displaying ARR without any additional pulse arrhythmia type icon.
Note: It is strongly recommended, that you consult your physician, if either the ARR icon occurs newly for several times, or,
if your ARR is known to your doctor, but the incidence of ARR readings changes over time. This is independent whether
the ARR icon is specified by another pulse arrhythmia icon or not. Your doctor will then be able to provide all required
medical test and possible therapeutic procedures. The the Pic Pulse detector is able to detect and display combined
pulse arrhythmia findings.
DISPALY RESULTS
-
Normal finding
ARR Pulse Arrhythmia without type-specific detection
ARR PC Pulse Arrhythmia-Premature ventricular, atrial or nodal beat detection
ARR Afib
Pulse Arrhythmia-Atrial fibrillation detection
ARR Afib PC Combined Pulse Arrhythmia: Atrial fibrillation & Premature beats detection
REAL FUZZY MEASURING TECHNOLOGY
This unit uses the oscillometric method to detect your blood pressure. Before the cuff starts inflating, the device will establish a
baseline cuff pressure equivalent to the air pressure. This unit will automatically determine the appropriate inflation level based
on pressure oscillations, followed by cuff deflation. During the deflation, the device will detect the amplitude and slope of the
pressure oscillations and thereby determine your actual the systolic blood pressure, diastolic blood pressure, and pulse rate.
NAME/FUNCTION OF EACH PART
Arm Cuff
Memory Key
START/STOP key
User-Switching key
Cuff Holder
Battery Cover
List of included items: Monitor, M-L size Cuff ( 02009228000000), 4xLR03 type (size AAA), cuff holder, User manuals, bag.
FEATURES:
• 65x72 mm LCD display • 3 keys • Two memory areas + guest mode • 60 recorded measurement per area • Deflation-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.
P 281 C
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 BLOOD PRESSURE
The blood pressure classification published by World Health Organization (WHO) and International Society of Hypertension
(ISH) in 1999 is as follows:
Note: It is not intended to provide a basis of any type of rush toward emer-
SEVERE - Grade 3 hypertension gency conditions/diagnosis based on the scheme: the scheme is meant
only to discriminate between the different levels of blood pressure.
MODERATE - Grade 2 hypertension
WARNING! For specific information on your own blood pressure,
contact your physician.
MILD - Grade 1 hypertension
High-normal Blood Pressure WARNING!
The appearance of the ARR icon indicates that a pulse irregularity consistent
Normal Blood Pressure
with an irregular heartbeat was detected during measurement. Usually this
Optimal Blood is NOT a cause for concern. However, if the symbol appears often, we recom-
Pressure
mend 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.
Systolic blood pressure (mmHg)
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 SYMBOL DESCRIPTION
Arrhythmia detection: Pic Pulse detector Morning and Nighttime Mark
Atrial Fibrillation Detection Memory/Date Mark
Premature Contraction Detection Memory Average Mark
Date/Time Indication Systolic/Maximum Pressure detected
Weak Battery Mark: batteries are low and need
to be replaced Diastolic/Minimum Pressure detected
Movement Mark: It can bring an inaccurate me-
asurement (See details on point a) below Pulse Rate (Pulse/minute)
Loose Cuff Detection: It can bring an inaccurate Pulse Mark: heartbeat detection during the
measurement (See details on point b) below measurement
Grade: level risk indicator for high blood pressure Guest mode or Memory Area Chosen (1 or 2)
This indication appears when measurement re- chosen. (See details on point c) below
sults, average or memories are displayed
). The ARR
a) Movement Detection
helps reminding the user to remain still and is indicating any adverse body movement during measurement. The specified
icon appears once a "body movement" has been detected during and after such a measurement.
Note: It's highly recommended that you measure again if the icon appears.
b) Loose Cuff Detection
If the cuff was applied too loosely, it may cause unreliable measurement results or measurements can fail to start. The "Loose
Cuff Detection" can help to determine if the cuff is wrapped snugly enough. The specified icon
cuff" has been detected during measurement. Otherwise the specified icon appears if the cuff is wrapped correctly during
measurement.
c) Guest Mode
monitor has a non-stored single measurement function. Press the User-Switching key to select the memory zone of guest
follow the Measurement Procedure to take a measurement correctly. When the measurement is completed, the measurement
value will not be stored in memory zone.
HYPERTENSION RISK INDICATION (HRI)
The World Health Organization, classifying blood pressure ranges into 6 grades. This unit is equipped with an innovative blood
pressure risk indication, which visually indicates the assumed risk level (optimal / normal / high-normal/ grade1 hypertension /
grade 2 hypertension / grade 3 hypertension) of your result, making the meaning of your findings comprehensive.
THE CHOICE OF POWER SUPPLY
1. Battery powered mode: 4 batteries 1,5V AAA; 6V.
2. Power supply with AC/DC adaptor: Input: 100 - 240V, 50 - 60Hz, 0,2A max - Output: 6V
May only be powered by "mains adaptor" 02009230000000 model HK-X205-A06 with a European plug and "mains adaptor"
02009229000000 model HK-X305-A06 with UK plug (not included).
Connect the DC connector of the AC/DC adaptor to the 6V plug located on the right hand side of the unit.
Plug the AC/DC adaptor into the mains socket.
WARNING!
1. Please unload the batteries when operating with the AC/DC adapter mode for a longer period of time . Leaving the batteries
in the compartment for a long time may cause leakage, which may lead to damage of the unit.
2. No batteries are needed when operating with the AC/DC adapter mode.
INSTALLING AND REPLACING THE BATTERIES
1. Press down and lift the battery cover in the direction of the arrow to open the battery compartment.
2. Install or replace 4 "AAA" sized batteries in the battery compartment according to the indications inside the compartment.
3. Replace the battery cover by clicking in the bottom hooks first, then push in the top end of the battery cover.
4. Remove batteries when unit is not in use for extended periods of time.
WARNING! The batteries must be replaced when
1. low battery icon appears on display.
LCD Display
2. no elements appear on the display when pressing the START/STOP button.
WARNING! In order to protect the device and for personal safety and to achieve optimal performance, use only the
batteries and adaptors indicated in this manual (Four 1,5V AAA batteries; 6V ).
WARNING!
• If the device will not be used for a while, please remove the batteries.
• The batteries used are harmful for the environment. Dispose of them in accordance with the instructions provided in this instruction manual
(EU directive 2006/66/EC).
Data Socket
• Do not dispose of batteries in fire. Batteries may explode or leak.
for Calibration
• 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.
Mains adapter
• Rechargeable batteries are not recommended.
connector
• The battery can explode if handled carelessly. Never recharge, remove or position the batteries near sources of heat. Do not
incinerate.
SETTING DATE AND TIME
Cuff connector
Setting the clock before using your blood pressure monitor is important and ensures that a time stamp can be assigned to
each measurement stored in the memory.
1. After having installed or replaced the batteries the display will show a flashing number that indicates the year.
2. Change the year by pressing the Memory key, each press will increase the number. Press the START/STOP button to confirm
the number entered; the screen will show a flashing number that indicates the date.
3. Change the date, hour and minute as described previously in point 2, using the Memory button to make changes and the
START/STOP button to confirm.
4. "0" will reappear as the Blood Pressure Monitor is ready for measurement again.
APPLYING THE CUFF (applied part)
1. Unwrap the arm cuff, leaving the end of the cuff through the metallic ring of the cuff.
2. Put your left arm through the cuff loop. The color strip indication should be positioned closer to you with the tube pointing
in the direction of your arm (Fig. 1). Turn your left palm upward and place the edge of the arm cuff at approximately 1.5 to
2.5 cm above the inner side of the elbow joint (Fig. 2). Tighten the cuff by pulling the end of the cuff.
3. Center the tube over the middle of the arm. 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 (Ø) over the main artery (on the inside of your arm) (Fig. 3 and 4).
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.
4. Plug in the cuff connecting tube into the unit (Fig. 5).
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 (Fig. 6).
6. This cuff is suitable for your use if the arrow falls within the solid color line as shown on the right (Fig. 7). If the arrow falls
outside the solid color line, you will need a cuff with other circumferences. Contact your local dealer for additional size cuffs.
3
Center tube over
Main 1
middle of arm
Artery
1.5 - 2.5 cm
(0.6" - 1.0")
2
5
MEASUREMENT PROCEDURES
Here are a few helpful tips to help you obtain more accurate readings:
• Blood pressure changes with every heartbeat and is in constant fluctuation throughout the day.
• Blood pressure recording can be affected by the position of the user, his or her physiological condition and other factors. For
greatest accuracy, wait one hour after exercising, bathing, eating, drinking beverages with alcohol or caffeine, or smoking
to measure blood pressure.
• Before measurement, it's suggested that you sit quietly for at least 5 minutes as measurement taken during a relaxed state will
have greater accuracy. You should not be physically tired or exhausted while taking a measurement.
• Do not take measurements if you are under stress or tension.
• During measurement, do not talk or move your arm or hand muscles.
• Take your blood pressure at normal body temperature. If you are feeling cold or hot, wait a while before taking a measurement.
• If the monitor is stored at very low temperature (near freezing), have it placed at a warm location for at least one hour before using it.
• Wait 5 minutes before taking the next measurement.
1. Press the User-Switching key to select memory zone 1, memory zone 2 or guest mode. After a memory zone is selected,
press the START/STOP key to reset the monitor so it can start measurement in the chosen memory zone.
2. Press the START/STOP key. All digits will light up, checking the display functions. The checking procedure will be completed
in 2 seconds.
3. After all symbols appear, the display will show a blinking "0". The monitor is ready to measure and will automatically inflate
the cuff slowly to start measurement.
4. When the measurement is completed, the cuff will exhaust the pressure inside. Systolic pressure, diastolic pressure and pulse will be
shown simultaneously on the LCD screen. The measurement is then automatically stored into the pre-designated memory zone.
5. In order to enhance the probability of pulse arrhythmia detection by the Pic Pulse detector technology, measurement
repetitions are recommended. This monitor will re-inflate automatically to approximately 220 mmHg if the system detects
that your body needs more pressure to measure your blood pressure.
Note: 1. This monitor automatically switches off approximately 1 minute after last key operation.
2. To interrupt the measurement, simply press the START/STOP key; the cuff will deflate immediately.
3. During the measurement, do not talk or move your arm or hand muscles.
RECALLING VALUES FROM MEMORY
1. The monitor has two memory zones (1 and 2). Each zone can store up to 60 measurements.
2. To read memory values from a selected memory zone, use the User-Switching key to select a memory zone (1 or 2) from
which you want to recall values. Press the Memory key. The first reading displayed is the average of all morning readings
from the last 7 days.
3. Continue to press the Memory key to view the average of all nighttime readings from the last 7 days.
4. Press the Memory key again to view the average of the last 3 measurements stored in memory, and the last previously stored
measurement. Every measurement comes with an assigned memory sequence number.
Note: The memory bank can store up to 60 readings per memory zone. When the number of readings exceeds 60, the oldest
data will be replaced with the new record.
Note: is defined as 4:00 AM - 11:59 AM
Note:
is defined as 6:00 PM - 2:00 AM
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 (60/60) is deleted from the list.
CLEARING VALUES FROM MEMORY
1. Press the User-Switching key to select memory zone 1 or memory zone 2.
2. Press and hold the Memory key for approximately 5 seconds, then the data in the memory zone can be erased automatically.
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
This blood pressure monitor was designed for long service periods. In order to ensure continued accuracy, it's recommended
that all digital blood pressure monitors require re-calibration. This monitor (under normal usage with approx. 3 measurements
a day) does not require re-calibration for 2 years. Once the unit should be re-calibrated the device will display
appears once a "loosen
should also be re-calibrated if the monitor sustains damage due to blunt force (such as dropping) or exposure to fluids and /
or extreme hot or cold temperature / humidity changes. When appears, simply return your device to your nearest dealer
for re-calibration service.
TROUBLESHOOTING
, and
• If any abnormality will arise during use, please check the following points.
• If the products not operating as you think it should, check here before arranging for servicing.
SYMPTOMS CHECK POINTS
Have the batteries run down?
No display when the START/STOP
key is pressed Have the batteries' polarities been
positioned incorrectly?
0,8A
Is the cuff placed correctly?
EE mark shown on display or the
Did you talk or move during
blood pressure value is displayed
measurement?
excessively low (high)
Did you vigorously shake the cuff
during measurement?
Note: If the unit still does not work, return it to your dealer. Under no circumstance should you disassemble and repair the
unit by yourself.
ERROR CODES FOR YOUR REFERENCE
EE / Measurement Error: Make sure the L-plug is securely connected to the air socket and calmly measure again. Wrap the cuff
correctly around your arm and keep arm steady during measurement. If the error keeps occurring, return the device to your
local distributor or service centre.
E1 / Air Circuit Abnormality: Make sure the L-Plug is securely connected to the air socket on the side of the unit and calmly
measure again. If the errors still occur, return the device to your local distributor or service centre for help.
E2 / Pressure Exceeding 300 mmHg: Switch the unit off and measure again quietly. If the error keeps occurring, return the
device to your local distributor or service centre
E3 / Data Error: Remove the batteries, wait for 60 seconds, and reload. If the error keeps occurring, return the device to your
local distributor or service centre.
Er / Exceeding Measurement Range: Measure again quietly. If the error keeps occurring, return the device to your local distri-
butor or service centre.
WARNINGS
1. The device is to be used for the non-invasive measurement and monitoring of blood pressure in adults, in a domestic or
professional setting.
2. This device is not suitable for use on newborns, children or pregnant women. The device has not been validated for use
with the categories of patients listed above and may be dangerous. It's suitability for use with teenagers must be evaluated
by a physician.
3. The device cannot be used on pre-eclamptic female.
4. The device is not suited for use on people whose arm circumference does not fall within the following interval: 24 to 40 cm.
5. People with reduced cognitive abilities must be supervised when using the device.
6. 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 tubes of the arm cuff and the cable of the AC/DC adaptor (optional)
may pose a strangulation hazard.
7. Do not confuse self-monitoring with self-diagnosis. This device can be used to monitor blood pressure, but it does not
replace a 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.
8. Please consult your physician before using the device if you have active implanted medical devices.
9. The unit contains high-precision assemblies. Therefore, avoid extreme temperatures, humidity, and direct sunlight. Avoid
dropping or strongly shocking the main unit, and protect it from dust.
10. Clean the blood pressure monitor body and the cuff carefully with a slightly damp, soft cloth. Do not press. Do not wash
the cuff or use chemical cleaner on it. Never use thinner, alcohol or petrol (gasoline) as cleaner.
11. If the unit is stored near freezing, allow it to acclimate at room temperature before use.
12. This unit is not field serviceable. You should not use any tool to open the device nor should you attempt to adjust anything
inside the device. If you have any problems, please contact the store or the doctor from whom you purchased this unit or
please your local authorized Service Center.
13. As a common issue for all blood pressure monitors using the oscillometric measurement function, the device may have
difficulty in determining the proper blood pressure for users diagnosed with diabetes, poor circulation of blood, kidney
problems, or for users suffered from stroke, or for unconscious users.
14. This unit is able to detect common arrhythmia (atrial or ventricular premature beats or atrial fibrillation). The ARR, AFib and PC
icons are displayed after the measurement if Atrial Fibrillation and Premature Contraction was detected during the measure-
ment. If ARR, AFib or PC icons are displayed, you are advised to wait for a while and take another measurement. It is strongly
recommended that you consult your physician if the ARR, AFib or PC icons appears often.
4
15. While the given device is able to detect specific pulse arrhythmia, the measurement accuracy of the blood pressure meter
may be impaired with the occurrence of pulse arrhythmia.
16. To switch off the device at any moment press the START/STOP button; the air present in the arm cuff will be released
quickly.
17. Once the inflation reaches 300 mmHg, the unit will start deflating rapidly for safety reasons.
18. Electromagnetic interference: The device contains sensitive electronic components. Avoid strong electrical or electromag-
netic fields in the direct vicinity of the device (e.g. mobile telephones, microwave ovens). These may lead to temporary
impairment of measurement accuracy.
19. Dispose of device, batteries, components and accessories according to local regulations.
20. This monitor may not meet its performance specification if stored or used outside temperature and humidity ranges
specified in Specifications.
6 21. Please note that when inflating, the functions of the limb in question may be impaired.
22. During the blood pressure measurement, blood circulation must not be stopped for an unnecessarily long time. If the
device malfunctions, remove the cuff from the arm.
23. Avoid any mechanical restriction, compression or bending of the cuff line.
24. Do not allow sustained pressure in the cuff or frequent measurements. The resulting restriction of the blood flow may
cause injury.
7
25. 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.
26. Placing the ARM CUFF over a wound may cause further injury.
27. If a limb is being used for IV treatment, or has an IV access or an arterio-venous (A-V) shunt, placing the ARM CUFF on that
limb and inflating it may injure the PATIENT since it temporarily impedes blood flow
28. For persons who have had a mastectomy, placing the ARM CUFF on the same side as the mastectomy and inflating it may
cause injury; furthermore, the measurement may not be accurate.
29. 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.
30. The device is a non-AP/APG device and is not suitable for use in the presence of anaesthetic mixtures that are flammable
with air, oxygen or nitrous oxide.
31. The operator shall not touch DC output jack of AC/DC adapter and the patient simultaneously.
32. Only ever use the cuffs provided with the monitor or original replacement cuffs. Otherwise erroneous results will be recorded.
33. Batteries can be fatal if swallowed. You should therefore store the batteries and products where they are inaccessible to
small children. If a battery has been swallowed, call a doctor immediately.
SPECIFICATIONS
Power supply: Battery powered mode: 4 batteries 1,5V AAA; 6V
AC/DC Power Source: Can be powe red only with the "Adapter for blood pressure monitor":
EU version
Output 6V
(Input 100-240V - 50/60Hz 0.2A, Output 6V
Display: LCD 67 (L) x 74 (H) mm
Measurement method: Oscillometric
Measurement range: Rated cuff pressure: 0-299 mmHg
Pressure: 30 - 260 mmHg; Pulse: 40 - 199 beats/minute
Pressure Sensor: Semi conductor
Accuracy: Pressure: ± 3mmHg.
Pulse value: ±5% of reading
Inflation: Pump Driven
Deflation: Automatic Air Release Valve
Memory capacity: 60 memories for each zone x 2 zones
Auto-shut-off: 1 minute after last key operation
Permissible Operating
Temperature and Humidity: 10°C - 40°C (50°F - 104°F); 15% - 85% RH; 700 - 1060 hPa
Permissible Transport and
Storage Temperature, Humidity
and Atmosferic pressure: -10°C - 60°C (14°F - 140°F); 10% - 90% RH; 700 - 1060 hPa
Arm circumference: Adult: 24 - 40 cm (9.4" - 15.7")
Net Weight: 249.5g (G.W.) (w/o Batteries)
Dimensions: 96 (L) X 139.7 (W) X 63.2 (H) mm
Accessories: AC/DC Adaptors:
plug. Cuff: 02009228000000 -
Software version: 11
Mode of operation:
Continuous operation
Useful life:
10,000 Measurements
Degree of protection :
Type BF applied part (cuff )
IP Classification IP:
IP21: Protected against solid objects over 12 mm and against vertically falling drops of water.
*Specifications are subject to change without notice.
CONTACT INFORMATION
For further information on our products, please visit the website www.picsolution.com. Here you can find customer service
to 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.
. The unit
Guidance and manufacturer's declaration – electromagnetic emissions
The CARDIOAfib ( 02009200000100) 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
CORRECTION
RF emissions
Replace them with four new batteries. Group 1
CISPR 11
Re-insert the batteries in the correct
positions. RF emissions
Class [B]
CISPR 11
Wrap the cuff properly so that it is
positioned correctly. Harmonic emissions
Class A
IEC 61000-3-2
Voltage fluctuations/
Measure again. Keep wrist steady
flicker emissions Complies
during measurement.
IEC 61000-3-3
Guidance and manufacturer's declaration - electromagnetic Immunity
The CARDIOAfib ( 02009200000100) is intended for use in the electromagnetic environment specified below. The
customer or the user of the CARDIOAfib (
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
T
lines IEC 61000-4-11
Single phase: at 0°
0% U ; 300 cycle
T
Power frequency
30 A/m
(50/60Hz) magnetic
50Hz/60Hz
field IEC 61000-4-8
NOTE U is the a.c. mains voltage prior to application of the test level.
T
02009230000000, model HK-X205-A06 (Input 100-240V - 50/60Hz 0.2A,
0.8A, not included; UK version 02009229000000, model. HK-X305-A06
0.8A, not included.
02009230000000 with European plug and 02009229000000 with UK
00009228000000
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 CARDIOAfib ( 02009200000100) 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.
02009200000100) should assure that it is used in such an environment.
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.