Ecomed BU-92E Gebrauchsanweisung Seite 2

®
BY MEDISANA ®
Upper arm blood pressure
monitor
BU-92E
Instruction Manual -
GB Unit and LC-Display
Please check first of all that the unit is complete.
The following parts are included as standard:
• 1 ecomed blood pressure monitor BU-92E
• 1 cuff with air tube
• 4 batteries (type AA, LR6) 1.5 V
• 1 instruction manual
Please contact your supplier if you notice any
transport damage on unpacking the unit.
Proper use
•
This fully automatic electronic blood pressure monitor is intended for measuring the blood pressure at
home. It is a non-invasive blood pressure measurement system to measure the diastolic and systolic
blood pressure and pulse of an adult using a non-invasive technique by means of a cuff, which needs
to be fitted on the upper arm.
Contraindications
•
The device is not suitable for measuring the blood pressure of children. Ask your doctor before using it
on older children.
•
This blood pressure monitor is not suitable for persons with a strong arrhythmia.
Explanation of symbols Common factors of wrong measurements
•
Please keep quiet for 5-10 minutes and avoid
IMPORTANT
eating, drinking alcohol, smoking, exercising and
Follow the instructions for use!
bathing before taking a measurement. All these
Non-observance of these instructions
factors will influence the measurement result.
can result in serious injury or damage
•
Remove any garment that fits closely to your
to the device.
upper arm.
•
WARNING Always measure on the same arm (normally left).
•
These warning notes must be observed Measurements should be taken regularly at the
to prevent any injury to the user. same time of each day, as the blood pressure
varies even during the day.
CAUTION •
Any effort to support the arm during measurement
These notes must be observed to prevent
may increase the measured blood pressure.
any damage to the device. •
Make sure, you are in a comfortable, relaxed
position and do not move or constrict your
NOTE
muscles during measurement. Use a cushion to
These notes give you useful additional
support your arm if necessary.
•
information on the installation or
If the arm artery lies lower or higher than the
operation.
heart, a false reading will be obtained.
•
A loose or open cuff causes false readings.
•
With repeated measurements, blood accu-
Device classification: type BF applied part
mulates in the arm which can lead to false
reading. Consecutive blood pressure measure-
Keep dry ments should be repeated after 1 minute pause
or after the arm has been held up in order to
allow the accumulated blood to flow away.
LOT number
Manufacturer
Date of manufacture
GB
Safety Instructions
Read the instruction manual carefully before
using this device, especially the safety
instructions, and keep the instruction manual
for future use. Should you give this device to
Influencing and evaluating readings
another person, it is vital that you also pass on
•
Measure your blood pressure several times, then record and compare the results. Do
these instructions for use.
not draw any conclusions from a single reading.
•
Your blood pressure readings should always be evaluated by a doctor who is also famil-
iar with your personal medical history. When using the unit regularly and recording the
values for your doctor, you should visit the doctor from time to time to keep him updated.
•
When taking readings, remember that the daily values are influenced by several factors.
Smoking, consumption of alcohol, drugs and physical exertion influence the measured
values in various ways.
•
Measure your blood pressure before meals.
•
Before taking readings, allow yourself at least 5-10 minutes rest.
•
• If the systolic and diastolic readings seem unusual (too high or too low) on several
The unit is intended only for use in the home. Consult your doctor prior to using the blood
occasions, despite correct use of the unit, please inform your doctor. This also applies to
pressure monitor if you are concerned about health matters. i
• the rare occasions when an irregular or very weak pulse prevents you from taking
Only use the unit for its intended purpose in accordance with the instructions for use. War-
readings.
ranty claims become void if the unit is misused. i
•
Irregularity of pulse or arrhythmia can lead to difficulties in recording a correct reading
when measurements are taken using oscillometric blood pressure devices. This device is Starting up
electronically equipped to detect over 20 of the most commonly occurring types of arrhyth-
Insert / replace batteries
mia and movement artifacts and indicates this with a symbol in the display. i
•
You must insert the batteries provided before you can use your unit. The lid of the battery
Please consult your doctor prior to using the unit if you suffer from illnesses such as arterial
compartment
occlusive disease. i
• type 1.5 V batteries supplied. Ensure correct polarity when inserting the batteries (as
The unit may not be used to check the heart rate of a pacemaker. i
• marked inside the battery compartment). Close the battery compartment.
Pregnant women should take the necessary precautions and pay attention to their indivi-
Replace the batteries if the change battery symbol
dual circumstances. Please consult your doctor if necessary. i
•
nothing appears on the display after the batteries have been inserted correctly.
If you experience discomfort during a measurement, such as pain in the upper arm or other
complaints, press the START-button to release the air immediately from the cuff. i
Loosen the cuff and remove it from your arm. i Setting date and time
•
The unit is not suitable for children. i
After inserting the batteries, time and date are shown in turns on the display
•
Do not allow children to use the unit. Medical products are not toys! i
hold START-button
•
Please ensure that the unit is kept away from the reach of children. i
and the month figure (M) starts to flash. Adjust the correct month by pressing the MEM-button
•
The swallowing of small parts like packaging bag, battery, battery cover and so on may
and press the START-button
cause suffocation. i
steps for day, hours and minutes, until these are correctly adjusted. Press the START-button
•
If the device has been stored in cold places, allow it to acclimate to room temperature be-
after adjustment of the minute figure to return to the normal display of time and date. After
fore use. i
approx. 1 minute without any button pressed, the device will automatically return to the
•
Only the cuff provided can be used, and cannot be changed to any other branded cuff. It
display of time and date. If the batteries are changed, the set information is lost and needs to
can only be replaced with a cuff of exactly the same type. i
be input again.
•
The device may not be operated in rooms with high levels of radiation or in the vicinity of
high-radiation devices, such as radio transmitters, mobile telephones or microwaves, as
Fitting the cuff
this could cause functional defects or incorrect measurements (see "electromagnetic com-
patibility"). i 1. Push the end piece of the air tube into the hole on the left side of the unit
•
Do not use the equipment where flammable gas (such as anaesthetic gas, oxygen or 2. Slide the open end of the cuff through the metal bracket so that the Velcro fastener is on
hydrogen) or flammable liquids (such as alcohol) are present. i the outside and it becomes a cylindrical form (Fig.1). Slide the cuff over your left upper
•
No modification of this unit/device is allowed. Do not disassemble the device. i arm.
•
The error-free and safe operation is only ensured, if the device is stored and used within 3. Position the air hose in the middle of your arm in line with your middle finger (Fig.2) ( ).
the surrounding parameters as described under "Technical details". i The lower edge of the cuff should be 1 - 2 cm above the crease of the elbow. ( ). Pull the
•
Please do not attempt to repair the unit yourself in the event of malfunctions, since this will cuff tight and close the Velcro fastener ( ).
void all warranty claims. Only have repairs carried out by authorised service centres. i 4. Measure the pulse on your bare arm.
•
Protect the unit against high temperatures, direct sunlight and moisture. If liquid does 5. Only position the cuff on the right arm if it cannot be used on the left arm. Always carry out
manage to penetrate into the unit, remove the batteries immediately and do not continue to measurements on the same arm.
6. Correct measuring position for sitting (Fig.3).
use the unit. In this case contact your specialist dealer or notify us directly. i
•
The monitor can maintain the safety and performance characteristics for a minimum of
10,000 measurements or three years, and the cuff integrity is maintained after 1,000 open–
Taking a blood pressure measurement
close cycles of the closure. i
After the cuff has been appropriately positioned,the measurement can begin.
•
Please do not hit the device heavily or let if fall down from a high place. i
• 1. Press the START-button
On the rare occasion of a fault causing the cuff to remain fully inflated during measurement,
shown (display test). This test can be used to check that the display is indicating properly
open the cuff immediately. Prolonged high pressure (cuff pressure >300 mmHg or constant
and completely.
pressure >15 mmHg for more than 3 minutes) applied to the arm may lead to an ecchy-
2. Now "U1" (User memory 1) or "U2" (User memory 2) are flashing in the display
mosis. i
pressing MEM-button
•
The device is not suitable for use on patients undergoing intravascular therapy or arterio-
do not press any button for approx. 5 seconds to start the cuff inflation.
venous shunt or people who received a mastectomy. i
• 3. The device is ready for measurement and the number 0 and the symbol "ready to inflate"
Never apply the cuff over hurt skin. i
•
If the unit is used by more than one person, each user should use his own cuff for hygieni-
to measure your blood pressure.
cal reasons. The cuffs can be purchased seperately in the commerce. i
4. The rising pressure in the cuff is shown on the display. The unit inflates the cuff until
•
Avoid compression or restriction of the connection tubing during measurement, as this may
sufficient pressure has built up for a measurement. Then the unit slowly releases air from
cause inflation errors or harmful injuries. i
• the cuff and carries out the measurement. When the device detects the signal, the heart
Do not use this unit in a moving vehicle. This may result in erroneous measurement. i
• symbol
If the unit is not going to be used for a long period, please remove the batteries.
5. When the measurement is finished, the cuff is deflated completely. The systolic and
diastolic blood pressure and the pulse value appear on the display
SAFETY NOTES FOR BATTERIES
sure indicator
•
Do not disassemble batteries! i pressure classification. If the unit has detected an irregular heartbeat, the arrhythmia
•
Replace all batteries if the unit display shows the low battery symbol. i
display
•
Never leave any low battery in the battery compartment since it may leak and cause
damage to the unit. i
•
Increased risk of leakage! Avoid contact with skin, eyes and mucous membranes! If
battery acid comes in contact with any of these parts, rinse the affected area with copious
amounts of fresh water and seek medical attention immediately! i
•
If a battery has been swallowed, seek medical attention immediately! i
•
Replace all of the batteries simultaneously! i
6. The readings are automatically saved in the selected memory (U1 or U2). Up to 60
•
Only replace with batteries of the same type, never use different types of batteries to-
measured values with date and time can be stored in each memory.
gether or used batteries with new ones! i
7. The measurement readings remain on the display. The unit switches off automatically
•
Insert the batteries correctly, observing the polarity! i
(however, date and time will still be displayed) after approx. 1 minute if no buttons are
•
Remove the batteries from the device if it is not going to be used for an extended period
pressed. The unit may also be switched off using the START-button
of 3 months or more! i
•
Keep batteries out of children's reach! i
• Discontinuing a measurement
Do not attempt to recharge batteries! There is a danger of explosion! i
•
If it is necessary to interrupt a blood pressure measurement for any reason (e.g. the patient
Do not short circuit! There is a danger of explosion! i
• feels unwell) the START-button
Do not throw into a fire! There is a danger of explosion! i
•
decreases the cuff pressure automatically.
Do not throw used batteries into the household refuse; put them in a hazardous waste
container or take them to a battery collection point, at the shop where they were pur-
chased! Display stored values
This unit features 2 separate memories, each with a capacity of 60 memory slots. Results
Unit and LCD display
are automatically stored in the memory selected by the user. Press the MEM button
when power off (but still time and date are displayed), to call up the measured values
LCD screen (display) MEM-button START-button Battery Compartment (on
stored. "U1" or "U2" will be flashing in the display
underside) Push-in Connector for air tube Cuff with air tube
the number of total results stored in this memory slot. Press START-button
Display of Date/Time Display of Systolic Pressure Display of Diastolic Pressure
between U1 and U2. Press MEM-button
/ Pulse Rate Symbol „ready to inflate" Change Battery symbol
conds) and the average values of the 3 last results stored will be displayed (along with the
Pulse symbol / Arrhythmia display (arrhythmia cordis) Blood Pressure Indicator
memory symbol
(green - yellow - orange - red) Memory-Symbol
button
pressing the MEM-button
have reached the final entry and do not press a button, the unit automatically switches
What is blood pressure?
itself off (however, date and time will still be displayed) after approximately 1 minute.
Blood pressure is the pressure created in the blood vessels by each heart beat. When the
Memory recall mode can be exited at any time by pressing the START-button
heart contracts (= systole) and pumps blood into the arteries, it brings about a rise in pres-
will also switch the unit off. The oldest value is deleted if 60 measured values have been
sure. The highest value is known as the systolic pressure and is the first value to be
stored in the memory and a new value is saved.
measured. When the cardiac muscle relaxes to take in fresh blood, the pressure in the ar-
teries also falls. Once the arteries are relaxed, a second reading is taken – the diastolic
pressure. Memory - clear of measurements
If you are sure that you want to permanently remove all stored memories, press and hold
the MEM-button
How is blood pressure measured?
value (except during the display of the average value). The device will beep 3 times and
The ecomed BU-92E is a blood pressure unit which is used to measure blood pressure
will then delete all stored results in the respective memory slot. The display will show
at the upper arm. The measurement is carried out by a microprocessor, which, via a
"- -".
pressure sensor, measures the vibrations resulting from the inflation and deflation of the
cuff over the artery.
Troubleshooting
The following symbol will appear on the display when measuring abnormal:
Blood pressure classification WHO
•
The battery change symbol "
These values have been specified by the World Health Organisation (WHO)
or empty. Replace all four batteries with new batteries of type 1.5V, AA LR6.
without making any allowance for age.
•
Unusual measurement results or "HI" or "Lo" are displayed:
Low blood pressure systolic <100 diastolic <60
Fit the cuff correctly and assume the correct position. Keep still during the measurement.
Normal blood pressure (green display area )
This blood pressure monitor is not suitable for persons with a strong arrhythmia.
systolic 100 - 139 diastolic 60 - 89
•
This unit is able to detect different errors and emits an according error code. A running
measurement will be aborted:
Mild hypertension (yellow display area )
"Er 0" to "Er 4": Failure in pressure system or failed to detect systolic resp. diastolic
systolic 140 – 159 diastolic 90 – 99
Moderate hypertension (orange display area )
systolic 160 – 179 diastolic 100 – 109
Severe hypertension (red display area ) "Er 5":
systolic ≥ 180 diastolic ≥ 110
"Er 6":
"Er 7" / "Er 8" /
WARNING
"Er A":
Blood pressure that is too low represents just as great a health risk as
blood pressure that is too high! Fits of dizziness may lead to dangerous
Important: Please contact your doctor if the error messages appear repeatedly. Keep still
situations arising (e.g. on stairs or in traffic)!
and do not move during the measurement.
Cleaning and care
Remove the batteries before cleaning the unit. Clean the unit using a soft cloth lightly
i moistened with a mild soapy solution. Never use abrasive cleaning agents, alcohol, naphtha,
thinner or gasoline etc.. Never immerse the unit or any component in water. Be cautiious not
to get any moisture in the main unit.
Do not wet the cuff or attempt to clean the cuff with water. Using a dry cloth, gently wipe
away any excess moisture that may remain on the cuff. Lay the cuff flat in an unrolled posi-
tion and allow the cuff to air dry. Do not expose the unit to direct sunlight; protect it against
i
dirt and moisture. Do not expose the unit to extreme hot or cold temperatures. Keep the de-
i
vice in the original packing when not in use. Store the unit in a clean and dry location.
i
Disposal
This product must not be disposed of together with domestic waste. All users are ob-
liged to hand in all electrical or electronic devices, regardless of whether or not they
contain toxic substances, at a municipal or commercial collection point so that they
can be disposed of in an environmentally acceptable manner. Remove the batteries
before disposing of the device/unit. Do not dispose of old batteries with your house-
hold waste, but at a battery collection station at a recycling site or in a shop. Consult your
local authority or your supplier for information about disposal.
is located on the underside of the unit. Open it and insert the 4 AA LR6
Guidelines / Standards
i
This blood pressure monitor meets the requirements of the EU standard for non-invasive
appears on the display or if
blood pressure monitors. It is certified in accordance with EC Guidelines and carries the
CE symbol (conformity symbol) "CE 0297". The blood pressure monitor corresponds to
European standards EN 60601-1, EN 60601-1-2, EN 80601-2, EN 1060-1 and EN 1060-3.
The specifications of EU Guideline "93/42/EEC of the Council Directive dated 14 June
1993 concerning medical devices" are met.
. Press and
and MEM-button at the sime time, until a short beep can be heard
Electromagnetic compatibility: Guidance and manufacturer's declaration
to confirm and proceed to the day figure. Repeat these th
(as per 25 March 2014)
The blood pressure monitor is intended for use in the electromagnetic
environment specified below. The customer or the user of the blood
pressure monitor should ensure that it is used in such an environment.
prior to use.
Emissions test
i
RF emissions
i CISPR 11
i
i
RF emissions
CISPR 11
. A long beep can be heard and all display characters are
Harmonic emissions
i
IEC 61000-3-2
. By
you may switch between U1 and U2. Press START-button or
Voltage fluctuations/
i
flicker emissions
IEC 61000-3-3
flashes for approx. 2 seconds. The unit automatically inflates the cuff slowly in order
i
The blood pressure monitor is intended for use in the electromagnetic
on the display starts to flash. i
environment specified below. The customer or the user of the blood
pressure monitor should ensure that it is used in such an environment.
. The blood pres-
flashes next to the relevant coloured bar depending on the WHO blood
Immunity
also flashes.
WARNING
Electrostatic
Do not take any therapeutic measures on the basis of a self
discharge (ESD)
measurement. Never alter the dose of a medicine prescribed by a
IEC 61000-4-2
doctor.
i
.
Power frequency
(50 Hz)
magnetic field
IEC 61000-4-8
can be pressed at any time. The device immediately
i The blood pressure monitor is intended for use in the electromagnetic
environment specified below. The customer or the user of the blood
along with the memory symbol and
pressure monitor should ensure that it is used in such an environment.
to switch
(or do not press any button for approx. 5 se-
Immunity
test
and "A"). If no results are stored, "- -" will appear. Press the MEM-
again to display the most recently stored measurement result. Repeatedly
displays the respective values measured previously. If you
, which
Radiated
RF
IEC
61000-4-3
for approx. 3 seconds during the display of a freely chosen memory
" appears in the display: The batteries are too low
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
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 electro-
magnetic site survey should be considered. If the measured field strength in the
pressure. The connection to the air hose could be interrupted. Check the location in which the "blood pressure monitor" is used exceeds the applicable RF
compliance level above, the blood pressure monitor should be observed to verify
connections between the cuff and the main unit, fit the cuff correctly and
normal operation. If abnormal performance is observed, additional measures
repeat the measurement. Keep still during the measurement.
may be necessary, such as reorienting or relocating the "blood pressure monitor".
The pressure in the cuff is too high (over 300 mmHg).
Relax for 5 minutes and repeat the measurement.
b. Over the frequency range 150 kHz to 80 MHz, field strengths should be less
The pressure in the cuff is over 15 mmHg since more than 3 minutes.
than [V1] 3 V/m.
Relax for 5 minutes and repeat the measurement.
Recommended separation distances between portable and mobile
Electronic-, parameter- or sensor error. Relax for 5 minutes and repeat
RF communications equipment and the blood pressure monitor
the measurement.
The "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 blood pressure monitor can help prevent
electromagnetic interference by maintaining a minimum distance between
portable and mobile RF communications equipment (transmitters) and the
"blood pressure monitor" as recommended below according to the
maximum output power of the communications equipment.
Rated maximum
i
output power
of transmitter
W
0.01
0.1
1
10
100
For transmitters rated at a maximum output power not listed above, the
recommended separation distance d in meters (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 1 At 80 MHz and 800 MHz, the separation distance for 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.
i
Technical specifications
Name and model
Display system
Memory slots
Measuring method
Electromagnetic emissions
Power supply
Blood pressure measuring range
Pulse measuring range
Maximum error tolerance for
static pressure
Maximum error tolerance for
Electromagnetic
pulse rate
Compliance environment-
Pressure generation
guidance
Deflation
The "blood pressure monitor"
Operating conditions
uses RF energy only for its
Storage conditions
Group 1 internal function. Therefore, its
Dimensions (L x W x H)
RF emissions are very low and
Cuff
are not likely to cause any
Weight (main unit)
interference in nearby
Item number
electronic equipment.
EAN number
Acessories
The "blood pressure monitor"
Class B is suitable for use in all es-
tablishments other than
domestic and those directly
Not applicable connected to the public low-
In accordance with our policy of continual product improvement, we
voltage power supply network
reserve the right to make technical and visual changes without notice.
that supplies buildings used
Not applicable
for domestic purposes. The current version of this instruction manual can be found under
Electromagnetic immunity
Warranty and repair terms
Please contact your supplier or the service centre in case of a claim under the
warranty. If you have to return the unit, please enclose a copy of your receipt and
state what the defect is.
The following warranty terms apply:
IEC 60601 Compliance Electromagnetic
test test level level -
environment
1. The warranty period for ecomed products is two years from date of purchase.
guidance
In case of a warranty claim, the date of purchase has to be proven by means
of the sales receipt or invoice.
± 6 kV contact ± 6 kV contact Floors should be wood,
concrete or ceramic tile.
2. Defects in material or workmanship will be removed free of charge within the
± 8 kV air ± 8 kV air
If floors are covered with
warranty period.
synthetic material, the
3. Repairs under warranty do not extend the warranty period either for the unit
relative humidity should be
or for the replacement parts.
at least 30 %.
4. The following is excluded under the warranty:
a. All damage which has arisen due to improper treatment, e.g.
3 A/m 3 A/m Power frequency magnetic
nonobservance of the user instructions.
fields should be at levels
b. All damage which is due to repairs or tampering by the customer or
characteristic of a typical
unauthorised third parties.
location in a typical commercial
c. Damage which has arisen during transport from the manufacturer to the
or hospital environment.
consumer or during transport to the service centre.
d. Accessories which are subject to normal wear and tear as batteries, cuff etc..
5. Liability for direct or indirect consequential losses caused by the unit are
Electromagnetic immunity
excluded even if the damage to the unit is accepted as a warranty claim.
MEDISANA AG, Jagenbergstr. 19, 41468 NEUSS, GERMANY.
ECOMED is a registered trademark of MEDISANA AG.
IEC 60601 Compliance Electromagnetic environment -
test level level guidance
Portable and mobile RF communications
equipment should be used no closer to any part of
the "blood pressure monitor" including cables than
the recommended separation distance calculated
from the equation applicable to the frequency of
+44 20 38680977
the transmitter.
service.gb@medisana.com
Recommended separation distance:
3 V/m
d=1.2 80 MHz to 800 MHz
80 MHz to 3 V/m
d=2.3 800 MHz to 2,5 GHz
2,5 GHz
where P is the maximum output power rating of the trans-
mitter in watts (W) according to the transmitter manu-
facturer and d is the recommended separation distance in
metres (m). Field strengths from fixed RF transmitters,
a
as determined by an electromagnetic site survey, should
be less than the comcompliance level in each frequency in
each frequency range. Interference may occur in the b
vicinity of equipment marked with the following Symbol:
absorption and reflection from structures, objects and people.
Separation distance according to frequency of transmitter
m
150 kHz to 80 MHz 80 MHz to 800 MHZ 800 MHz to 2.5 GHz
d=1.2 d=1.2 d=2.3
0.12 0.12 0.23
0.38 0.38 0.73
1.2 1.2 2.3
3.8 3.8 7.3
12 12 23
: ecomed Upper arm blood pressure monitor BU-92E
: Digital display
:
2 x 60 measurement values with time & date
: Oscillometric
: 6 V=, 4 x 1.5V batteries AA LR6
: 40 – 260 mmHg
: 40 – 180 beats/min.
: ± 3 mmHg
: ± 5 % of the value
: Automatic with pump
: Automatic
: +5 °C to +40 °C, 90 % max. relative humidity
: -20 °C to +55 °C, 90 % max. relative humidity
: Approx. 136 x 100 x 65 mm
: 22 - 30 cm for adults
: Approx. 236 g without batteries and cuff
: 23205
: 40 15588 23205 3
: • Cuff, large 30 - 42 cm for adults with upper arm of
large circumference Art.-Nr. 51126
• Cuff, normal 22 - 30 cm for adults with upper arm of
normal circumference Art.-Nr. 51135
www.medisana.com