(8) Power source: 3 x AA size batteries (18) Transport condition:
(9) Classification: Internal powered Equipment Type B Atmospheric pressure range: 80kPa~105kPa
(10) Pressurisation: automatic air inflation by an air pump Humidity range: Less than 95%
(11) Deflation: Automatic exhaust Ambient temperature range: -20~60
o
C
This is a Class IIa medical device and fulfils the provisions of the medical devices directive 93/42/EEC
Blood pressure measurements determined with this device are equivalent to those obtained by a trained
observer using the cuff/stethoscope auscultation method, within the limits prescribed by the American
National Standard, Electronic or automated sphygmomanometers.
15
Specification
Regarding 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;
Regarding the application of the CUFF and its pressurization on the arm on the side of a mastectomy;
Regarding the information that pressurization of the CUFF can temporarily cause loss of function of
simultaneously used monitoring ME EQUIPMENT on the same limb;
Regarding the need to check (for example, by observation of the limb concerned) that operation of the
AUTOMATED SPHYGMOMANOMETER does not result in prolonged impairment of the circulation of the blood of
the PATIENT.
When the arm is oppressed by air pressure,please loosen CUFF or remove batteries.
Not touch the patient and battery output simultaneously when measurement.
Warning: not allow to use the luer connectors.If Luer lock connectors are used in the construction of tubing,
there is a possibility that they might be inadvertently connected to intravascular fluid systems, allowing air to be
pumped into a blood vessel.
Warning and safety notices
Product may be returned if faulty, please contact the Retailer or Kinetik directly if you’re experiencing issues with
your product. This does not affect your statutory rights. Please note the retailer’s own return policy may still be valid,
contact the retailer for more information.
16
EMC Table
Emission test
RF emission
Harmonic
Voltage
Group 1
Class B
Not applicable
Not applicable
The Digital Blood Pressure Monitor use 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 Digital Blood Pressure Monitor is suitable for use in all establishments other than domestic and those directly connected to
the public low-voltage power supply network that supplies buildings used for domestic purposes.
CISPR 11
RF emissions
emissions
fluctuations/
flicker emissions
IEC 61000-3-3
IEC 61000-3-2
CISPR 11
Compliance
Electromagnetic environment – guidance
The Digital Blood Pressure Monitor is intended for use in the electromagnetic environment specified below. The customer of the user of the Digital Blood Pressure
Monitor should assure that it is used in such an environment.
Power frequency
magnetic field IEC
61000-4-8
±6 kV contact
±8 kV air
±6 kV contact
±8 kV air
3V/m3V/m
(50Hz/60Hz)
Electrostatic
IEC 61000-4-2
discharge (ESD)
Immunity test
IEC 60601 test level
Compliance level
The Digital Blood Pressure Monitor is intended for use in the electromagnetic environment specified below. The customer or the user of Digital Blood Pressure Monitor
should assure that it is used in such an environment.
Guidance and manufacture’s declaration
Guidance and manufacture’s declaration – electromagnetic emission
NOTE UT is the a.c. mains voltage prior to application of the test level.
Floors should be wood, concrete or ceramic tile. If floor are covered with
synthetic material, the relative humidity should be at least 30%.
Power frequency magnetic fields should be at levels characteristic of a
typical location in a typical commercial or hospital environment.
Electromagnetic environment – guidance
The Digital Blood Pressure Monitor is intended for use in the electromagnetic environment specified below. The customer or the user of Digital Blood Pressure Monitor
should assure that it is used in such an environment.
Guidance and manufacture’s declaration – electromagnetic immunity
Guidance and manufacture’s declaration – electromagnetic immunity
17
EMC Table
Immunity test
Radiated RF
IEC 61000-4-3
3V/m
80 MHz to
2.5 GHz
3V/m
Portable and mobile RF communications equipment should be used no closer to any part of the Digital Blood
Pressure Monitor, including cables, than the recommended separation distance calculated from the equation
applicable to the frequency of the transmitter.
Recommended separation distance
80 MHz to 800 MHz
800 MHz to 2.5 GHz
Where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter
manufacturer and d is the recommended separation distance in metres (m).
Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey
a
, should be less
than the compliance level in each frequency range.
b
Interference may occur in the vicinity of equipment marked with the following symbol:
IEC 60601 test
level
Compliance
level
a
Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio
broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an
electromagnetic site survey should be considered. If the measured field strength in the location in which the Digital Blood Pressure Monitor is used exceeds the
applicable RF compliance level above, the Digital Blood Pressure Monitor should be observed to verify normal operation. If abnormal performance is observed,
additional measures may be necessary, such as reorienting or relocating the Digital Blood Pressure Monitor.
b
Over the frequency range 150 KHz to 80 MHz, field strengths should be less than 3V/m.
NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.
Electromagnetic environment - guidance
18
EMC Table
output power
of transmitter
The Digital Blood Pressure Monitor is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or
the user of the Digital Blood Pressure Monitor can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile
RF communications equipment (transmitters) and the Digital Blood Pressure Monitor as recommended below, according to the maximum output power of the
communications equipment.
For transmitters rated at a maximum output power not listed above, the recommended separation distance d in metres (m) can be estimated using the
equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the
transmitter manufacturer.
NOTE 1At 80 MHz and 800 MHz. the separation distance for the higher frequency range applies.
NOTE 2These guidelines may not apply in all situations .Electromagnentic propagation is affected by absorption and reflection from structures, objects
and people.
80 MHz to 800 MHz
800 MHz to 2.5GHz
Recommended separation distances between
portable and mobile RF communications equipment and the Digital Blood Pressure Monitor.
Separation distance
according to frequency of transmitter
(m)
100
10
0.1
0.01
1
11.66 7
3.689
0.369
0.117
1.167
23.333
7.379
0.738
0.233
2.333
19
Frequently Asked Questions
What is the difference between systolic and diastolic pressure?
Your heart is just like a pump which works all the time to make the blood flow through all blood vessels. Blood pressure measures
the force on the wall of the blood vessels caused by the pressure of the blood.
Systolic pressure is the pressure of the blood when your heart beats to pump blood out.
Diastolic pressure is the pressure of the blood when your heart rests in between beats. This reflects how strongly your arteries are
resisting blood flow.
If you want to measure again, just press the START/STOP button twice. Leave at least three minutes between measurements to
allow blood circulation to the arm to return to normal. Do not measure your blood pressure too many times in one session as it may
cause discomfort in the arm.
Blood pressure fluctuates constantly during the day. Its value in the daytime is higher than in the evening with the lowest level
being at midnight. The pressure begins to rise again at 3:00am and reaches its highest level any time during the day – so it is
impossible to get a consistent reading. For this reason, please take your measurements at the same time of day
Relax for 10-20 minutes before taking a measurement and remain relaxed whilst measuring. Do not move or talk during
measurement, as this will affect the accuracy.
Measure one hour after eating and avoid measuring immediately after bathing. Measure one hour after smoking or drinking
alcohol/coffee.
What if I want to retest?
When is the best time to test my blood pressure?
20
Frequently Asked Questions
Do I need to test at the same time, every time?
We recommend that measurements are taken at the same time, under the same conditions and in the same position each time
because of the way your blood pressure constantly fluctuates depending on the time of day. This will help you to keep a more
accurate record over time and reduce any possible variances to your readings.
What if I get an error or abnormal reading?
Please see the troubleshooting guide at the end of this section
How do I know when I need to change the batteries?
When the Low Battery Indicator is displayed, new batteries must be inserted immediately to ensure accurate results. Do not mix
old and new batteries or different types of batteries.
Can I use rechargeable batteries?
No. You can only use standard alkaline batteries. Please dispose of batteries safely after use using your local battery re-cycling
facility.
21
Abnormality & Troubleshooting
Possible Problems & Solutions
Error Indicators
The following symbol will appear on the display when measuring abnormally.
Symbol
ProblemSolution
Cause
Cuff not fitted correctly or air leakage
detected.
No power.
Display is blank.
Measurement values appear too high or too low.
Wrap the cuff correctly and tightly ensuring the connection
between the air plug and the unit is good.
Do not move your arm or body, refrain from talking.
Replace batteries with new ones.
Replace batteries with new ones.
Check the batteries are inserted correctly observing the correct polarity.
Blood pressure varies constantly. Many factors including stress, time of day and how
you wrap the cuff may affect your blood pressure. Review the section
"Setting up your Blood Pressure Monitor".
Movement detected during measurement.
Low battery.
Correction
22
23
Blood Pressure Record Table
Please log the date, time and your SYS (systolic) and DIA (Diastolic) blood pressure levels.
We recommend you share this information with your Doctor
Libble takes abuse of its services very seriously. We're committed to dealing with such abuse according to the laws in your country of residence. When you submit a report, we'll investigate it and take the appropriate action. We'll get back to you only if we require additional details or have more information to share.
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