GB Safety instructions
GB
Instruction manual
Upper arm blood pressure monitor
Unit and LC-display
• This product is intended only for private use at home.
• Only use the unit for its intended purpose in accordance with the instructions for use. Warranty claims become void if the
unit is misused.
• The patient is an intended operator. The patient can measure data and change batteries under normal circumstances and
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maintain the device and its accessories according to the user manual. The applied part is the cuff.
• This blood pressure monitor is intended for use by adults aged 18 years and above. The device is not suitable for measuring
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the blood pressure of children or infants.
• Please ensure that the unit is kept away from the reach of children and pets. The swallowing of small part like packaging
bag, battery, battery cover and so on may cause suffocation.
• The device has sensitive components. Be careful and ensure that the operating and storage conditions are met.
• Wait at least 30 minutes after consuming caffeine or tobacco before taking a measurement.
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• Before taking a measurement, rest for 5-10 minutes and do not eat, drink alcohol, smoke, do not do any physical work, do
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not exercise or bathe. All these factors can influence the measurement result.
• Repeated measurements cause the blood to congestion, which can lead to a false result and/or unpleasant sensations (e.g.
numbness in the arm). Successive blood pressure measurements should be taken with 3-minute breaks. If the symptoms
do not subside within a few minutes, contact your doctor.
• Always measure on the same upper arm (usually left). For those who have had a mastectomy or lymph node clearance, it
is recommended to take a measurement on the unaffected side.
• Measure your blood pressure regularly, at the same time every day, because blood pressure changes throughout the day.
• Ensure a comfortable and relaxed position and do not tense any muscle of the arm being measured during the measurement.
If necessary, use a support cushion.
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• Keep calm during the measurement: do not move or speak, otherwise the measurement results may change.
• Extreme temperatures, humidity or altitude can affect the performance of the unit.
• Cuffs that are too loose or tight cuff may lead to incorrect measurements.
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7
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• Do not take measurements, if any other equipment is applied to the same limb for monitoring. This could lead to disturbances
or failures. This device is not suitable during intravenous injection to limbs or during dialysis treatment.
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• The device is not suitable for use on pregnant women, patients with implanted, electronical devices (e.g. pacemaker or
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0
q
defibrillator), patients with pre-eclampsia, premature ventricular beats, atrial fibrillation, peripheral, arterial disease and
patients undergoing intravascular therapy or arterio-venous shunt or people who received a mastectomy. Please consult
your doctor prior to using the unit if you suffer from illnesses.
• If you suffer from circulation problems, arteriosclerosis, diabetes, liver disease, kidney disease, severe hypertension or
a
(b)
2-3 cm
peripheral circulation problems, consult your doctor before using the device.
(a)
• This device is intended for non-invasive measuring and monitoring of arterial blood pressure on the upper arm. It is not
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intended for use on extremities other than the upper arm or for functions other than obtaining a blood pressure measurement.
• Do not take any therapeutic measures on the basis of a self measurement. Never alter the dose of a medicine prescribed by
o
w
a doctor. If you are taking medication,consult your physician to determine the most appropriate time to measure your blood
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i
pressure. Contact your doctor if you have any further questions about blood pressure measurement with this device.
• Irregularity of pulse or arrhythmia can lead to difficulties in recording a correct reading when measurements are taken using
u
(c)
oscillometric blood pressure devices. This device is electronically equipped to detect irregular heartbeat, which it indicates
z
with the icon
• Never bend the air hose during use as this may lead to injuries. Also never squeeze or block the air hose in any way.
• This device cannot be placed near or used at the same time as any surgical equipment.
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• Do not use this device if there are any wounds or injuries present on the arm.
• If you experience discomfort during a measurement, such as pain in the upper arm or other complaints, press the START/
t
r
e
STOP button
• If a fault occurs causing the cuff to remain fully inflated during measurement, open the cuff immediately. Prolonged high
pressure applied to the arm may lead to bruising.
• Before use, make sure the device functions safely and is in proper working condition. Do not service or maintain while the
Explanation of symbols
device is in use.
• Check the device for damage. The use of a damaged device can result in injury, incorrect readings or serious hazards.
IMPORTANT
• The unit may not be operated in the vicinity of appliances that emit strong electric radiation such as radio transmitters or
Please read the instruction manual and follow the instructions
mobile phones. This may affect the proper functioning (see "electromagnetic compatibility").
before use.
• The device and its components are suitable for use within the patient environment. If you are allergic to polyester, nylon or
Not observing these instructions could result in serious injury
plastic, please don't use this device.
or damage to the device.
• Do not touch output of batteries and the patient simultaneously.
• Please do not attempt to repair the unit yourself in the event of malfunctions. Only have repairs carried out by authorised
WARNING
service centres.
These warning notes must be observed to prevent any injury
• Only use original additional or spare parts from the manufacturer. Other parts could damage the device or could lead to
to the user.
personal injury.
• Please report to medisana if any unexpected operation or events occur.
CAUTION
These notes must be observed to prevent any damage to the
• Only use the device under the conditions mentioned in the technical details. Otherwise, the lifespan and performance of the
device.
device could suffer.
• If you have any infectious skin disease or the device is used by users with infectious skin disease, please do not continue
NOTE
using the device. Before using the device, user should check the appearance of cuff. If you notice blood or other soil on cuff,
These notes provide you with some useful additional informa-
please do not use this device. If there is one of above situations, please dispose of the device without reuse.
tion on installation or operation of this product.
• Protect the appliance from heavy blows and do not drop it.
WARNING: To avoid inaccurate results due to electromag-
• If the unit is not going to be used for a long period, please remove the batteries.
netic interference, portable RF communication devices
• Accuracy: In case it is needed to have the device checked for calibration, please consult the service center.
(including peripherals such as antenna cables and external
antennas) should not be closer than 30 cm to any part of the
BATTERY SAFETY INFORMATION
instrument. The performance of this device may be affected.
• Do not disassemble batteries!
Device classification:
• A battery icon on display indicates low power or incorrect direction of the batteries. We recommend that you replace the
type BF applied part
batteries with new ones and make sure the +/- ends of the batteries are placed correctly.
• To extend the service life of the batteries and prevent damage due to leakage, please remove the batteries from the device
Temperature range
Humidity range
if it has not been used for a long time.
• If battery leakage occurs, do not allow the battery acid to come into contact with your skin, eyes, or mucous membranes! If
IP22
Ingress protection rating
Atmospheric
battery acid comes in contact with any of these parts, rinse the affected area with copious amounts of fresh water and seek
pressure range
medical attention immediately!
Non-ionizing electromagnetic radiation
• If a battery is swallowed seek medical attention immediately!
• Replace all of batteries at the same time! Only replace batteries with those of the same type, and never use different types
LOT number
Serial number
of batteries together or used batteries with new ones.
• Insert the batteries correctly, observing the polarity!
Manufacturer
Date of manufacture
• Keep batteries out of children's reach!
• Do not attempt to recharge batteries, do not short-circuit and do not throw into a fire! There is a danger of explosion!
• Do not throw used batteries into the household refuse; put them in a hazardous waste container or take them to a battery
Device information:
collection point, at the shop where they were purchased!
• Internally powered equipment
• Not suitable for use in presence of flammable anesthetic mixture
Unit and LC-Display
with air or with oxygen or nitrous oxide
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Cuff
Connector for the hose
4
Intended use
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"+" button
• This fully automatic over-the-counter electronic blood pressure
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Average of the last 3 measurements
monitor is intended for measuring human's systolic and diastolic blood
e
Diastolic pressure
pressure and heart rate by using an oscillometrique technique by
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Blood Pressure Indicator (green - yellow - orange - red)
means of a cuff, which needs to be fitted on the upper arm. All values
Movement detected / cuff incorrectly applied
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can be read out in one LCD panel. The useable cuff circumference is
Measurement unit
p
23 to 43 cm. The device is intended for adult indoor use at home only.
• The device is able to detect irregular heartbeat and indicate this with a
Scope of supply
symbol.
Please check first of all that the device is complete and is not damaged in any way. In case of doubt, do not use it and contact
your dealer or your service centre.
Contraindication
The following parts are included:
• The device is not suitable for use on pregnant women and patients
• 1 medisana blood pressure monitor
with implanted, electronical devices (e.g. pacemaker or defibrillator).
• 4 batteries (type AAA, LR03) 1.5V
0197
• 1 instruction manual
Please contact your supplier if you notice any transport damage on unpacking the unit.
48916_BU 586 voice_manual_GB_TW_202406_L1
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 another person, it is vital that you also pass
on these instructions for use.
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. In this case, contact your physician.
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to release the air immediately from the cuff. Loosen the cuff and remove it from your arm.
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Air hose
3
Battery compartment (on backside)
START/STOP button
M-button
5
6
8
button (Time / Date)
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Timet (Hours : Minutes)
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Systolic pressure
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Low battery symbol
r
Irregular heartbeat
t
Pulse frequency
u
Pulse symbol
Voice output
o
Date (Month : Day)
a
• 1 cuff with air tube
• 1 storage pouch
WARNING - Please ensure that the polythene packing is kept out of reach of children as
there is risk of suffocation!
How is blood pressure measured?
This product is a blood pressure monitor used to measure blood pressure at the upper arm. This device can measure blood
pressure simultaneously with cuff inflation via a microprocessor, allowing for faster measurement than conventional methods.
Blood pressure classification
systolic mmHg
diastolic mmHg
Bloodpressure indicator
≥ 180
≥ 110
Stage 3 Hypertension emergency
160 - 179
100 - 109
Stage 2 Moderate hypertension
140 - 159
90 - 99
Stage 1 Mild hypertension
130 - 139
85 - 89
high-normal blood pressure
120 - 129
80 - 84
normal blood pressure
< 120
< 80
optimal blood pressure
WARNING - 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 situations arising (e.g. on
stairs or in traffic)!
Influencing and evaluating readings
• Measure your blood pressure several times, then record and compare the results. Do not draw any conclusions from a single
reading.
• Your blood pressure readings should always be evaluated by a doctor who is also familiar 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 five minutes rest.
• If the systolic and diastolic readings seem unusual (too high or too low) on several occasions, despite correct use of the unit,
please inform your doctor. This also applies to the rare occasions when an irregular or very weak pulse prevents you from
taking readings.
Getting started - Inserting/changing batteries
You must insert the batteries provided before you can use your unit. The lid of the battery compartment is located on the
underside of the unit. Open it, remove it and insert the 4 x 1,5 V batteries, type AAA / LR03 supplied. Ensure correct polarity
when inserting the batteries (as marked inside the battery compartment). Close the battery compartment. Replace the batteries
if the change battery symbol
w
appears on the display or if nothing appears on the display after the unit has been switched
on. (Please do not mix old and new batteries)
Settings - Setting date, clock and voice output options
Press the
- button
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to set the date and time. First the year flashes, which you can adjust with the "+" button
the -
- button
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again to confirm the entry and to move to the next setting option. Proceed in the same way for month, day,
hour and minute. You can then set the voice output options of the device. First use the "+" button
options: "1" = volume 1; "2" = volume 2; "OFF" = "Voice output deactivated". If you have not deactivated the voice output, you
can then select the language: L1: English, L2: Mandarin, L3: Taiwanese, L4: Indonesian, L5: Vietnamese, L6: Cantonese. The
device then switches back to the initial standby mode.
Fitting the cuff
1. Connect the air hose to the connector
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on the left side of the device.
2. Slide the open end of the cuff through the metal bracket so that the Velcro fastener is on the outside and
it becomes a cylindrical form (Fig.1). Slide the cuff over your left upper arm.
3. Position the air hose in the middle of your arm in line with your middle finger (Fig.2) (a). The lower edge
of the cuff should be 2 - 3 cm above the crease of the elbow. (b). Pull the cuff tight and close the Velcro
fastener (c).
4. Tighten the end of the cuff so that it wraps evenly around your arm, leaving room for 2 fingers between
the cuff and your arm.
5. Measure the blood pressure on your bare arm.
6. Only position the cuff on the right arm if it cannot be used on the left arm. Always carry out measurements on the same arm.
7. Correct measuring position for sitting (Fig.3). Make sure that the cuff does not slip during measurement and that the printed
arrow points to the crook of the arm.
User memory setting
The medisana blood pressure monitor features 2 separate memories, each with a capacity of 120 memory slots. Press the "+"
button
to select user memory 1 (display: no 1) or 2 (no 2).
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Taking a blood pressure measurement
1. After applying the cuff and setting the user memory, press the START/STOP button
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.
2. All display characters are shown (display test). This test can be used to check that the display is indicating properly and in
full. The unit is ready for measurement and „00" appears.
3. The device then automatically inflates the cuff slowly in order to measure your blood pressure. The rising pressure in the
cuff is shown on the display.
4. When the device detects the signal, the heart symbol
u
on the display starts to flash. If a result is determined, the device
slowly will release the air from the cuff. The systolic and diastolic blood pressure and the pulse value appear on the display.
5. If voice output is activated, the measured values are also emitted acoustically (however, no voice output will be emitted if the
battery voltage is low or if measurement errors occur).
6. The blood pressure indicator
appears next to the relevant coloured bar depending on the blood pressure classification.
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7. If the unit has detected an irregular heartbeat, the irregular heartbeat display
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measurement, press START/STOP button
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. The cuff will deflate immediately after the button is pressed.
8. The readings are automatically saved in the selected memory (1 or 2).
9. After about 1 minute without further operation, the machine switches off automatically.
Displaying stored results
This unit features 2 separate memories, each with a capacity of 120 memory slots. Results are automatically stored in the
memory selected by the user. To call up the stored measured values, press the "+" button
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no 1) or 2 (no 2). Then press the M-button
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. The average values of the last 3 measurements
now press the M-button
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again, the last measurement taken appears on the display. Press the M-button
through the measured values. By pressing the START/STOP button
you can leave the memory recall mode at any time and
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at the same time the device switches to standby mode. If 120 measured values are stored in the memory and a new value is
saved, the oldest value is deleted.
Deleting stored values
Enter the memory recall mode as described above and press and hold the
- button
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time. The memory of the relevant user memory is cleared ("CLA" appears).
Troubleshooting
Display
Cause
No display
Batteries do not have enough voltage or are
inserted incorrectly.
EE
Incorrect installation may lead to blood
pressure measurements which are falsely
high or low.
E1
Airflow anomaly. The air hose may not be
connected correctly.
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E2
Inflation pressure over 300 mmHg.
red
orange
E3
It is impossible to determine the blood
yellow
pressure value when the distance between
the cuff and the arm is too large.
green
green
If there is too much movement or talking
during measurement, or the cuff is not
green
applied correctly, measurement values may
be incorrect.
Cuff not correctly applied (e.g. too tight or too
loose).
EP
Contact the customer service.
Cleaning and maintenance
Remove the batteries before cleaning the unit. Clean the unit and cuff using a soft cloth lightly moistened with water. Never
use abrasive cleaning agents, alcohol, naphta, thinner or gasoline etc. Never immerse the unit or any component in water. Be
cautious 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 position and allow the cuff to
air dry. Do not expose the unit to direct sunlight; protect it against dirt and moisture. Do not expose the unit to extreme hot or
cold temperatures. Keep the device in the storage case when not in use. Store the unit in a clean and dry location.
Disinfection
1. If used by yourself in a home environment, wipe the cuff once a month with a commercially available cotton cloth with 75%
alcohol for more than 30 seconds at a time for disinfection in addition to the normal cleaning routine.
2. If used for more than one person (home use), wipe the cuff once a week with a commercially available cotton cloth with 75%
alcohol for more than 30 seconds at a time for disinfection in addition to the normal cleaning routine.
3. After cleaning/disinfection and before use, make sure that there are no blood stains or dirt on the display, the device or the
cuff. If there are blood spots or dirt that cannot be removed, please dispose of the device without reusing it.
4. If used in a complex environment (e.g. in a hospital) or by persons outside your own family, replace the cuff with a new one
after use.
Disposal
This product must not be disposed of together with domestic waste. All users are obliged to hand in all electrical or
electronic devices, regardless of whether or not they contain toxic substances, at a municipal or commercial collection
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. Then press
point so that they can be disposed of in an environmentally acceptable manner. Remove the batteries before dispo-
sing of the device/unit. Do not dispose of old batteries with your household waste, but at a battery collection station at
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to select from the following
a recycling site or in a shop. Consult your local authority or your supplier for information about disposal.
Guidelines / Standards
This blood pressure monitor meets the requirements of the EU standard for noninvasive blood pressure monitors. It is certified
in accordance with EC Guidelines and carries the CE symbol (conformity symbol) "CE 0197". The blood pressure monitor
corresponds to European standards EN 60601-1, EN 60601-1-2, EN 1060-3, EN 1060-4, EN 81060-1, EN 81060-2 and EN
80601-2-30. The specifications of EU Guideline "93/42/EEC of the Council Directive dated 14 June 1993 concerning medical
devices"are met.
Technical specifications
Name and description:
medisana Upper arm blood pressure monitor
Display system / Memory slots:
Digital display / 2 x 120
Measuring method / Mode of operation:
Oscillometric / Continuous operation
4 x 1.5V
Power supply:
0 - 300 mmHg
Rated cuff pressure:
40 - 280 mmHg
Measurement pressure:
40 - 199 beats per minute
Pulse measuring range:
Maximum error tolerance for static pressure:
± 3 mmHg
Maximum error tolerance for pulse rate:
± 5 % of the value
Pressure generation:
Automatic with pump
Deflation:
Automatic
Shelf life (batteries):
3 years (Temperature 20 ± 2°C; rel. humidity 65 ± 20 %)
Battery life:
Approx. 250 measurements
Product life span:
Approx. 5 years with 4 times daily use
Operating conditions:
+5°C to +40°C, 15 to 93 % relative humidity, non-condensing,
700-1060 hPa atmospheric pressure
Storage / Transportation conditions:
-25°C to +70°C, relative humidity ≤ 93 %
Dimensions / Cuff:
Approx. 137 x 98.5 x 52 mm / 23 - 43 cm (9" - 17")
Weight (main unit):
Approx. 276 g ± 5 g without batteries
Item number:
48916
EAN number:
40155 88 48916 7
Accessories (optional):
Cuff for BU 300, BU 310, BU 320 connect, BU 584 connect, BU 586 voice (Size:
Medium, circumference 23-33 cm)
appears additionally. To stop the
Art. No. 48132 / EAN 40155 88 48132 1
In accordance with our policy of continual product improvement, we reserve the right to make technical and visual
changes without notice.
Warranty and repair terms
to select user memory 1 (display:
0
appear on the display. If you
Please contact your supplier or the service centre in case of a claim under the warranty. If you have to return the unit, please en-
close a copy of your receipt and state what the defect is. The following warranty terms apply:
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again to scroll
1. The warranty period for medisana products is 3 years from date of purchase. In case of a warranty claim, the date of
purchase has to be proven by means of the sales receipt or invoice.
2. Defects in material or workmanship will be removed free of charge within the warranty period.
3. Repairs under warranty do not extend the warranty period either for the unit or for the replacement parts.
4. The following is excluded under the warranty:
a. All damage which has arisen due to improper treatment, e.g. nonobservance of the user instructions.
and the "+" button
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at the same
b. All damage which is due to repairs or tampering by the customer or unauthorised third parties.
c. Damage which has arisen during transport from the manufacturer to the consumer or during transport to the service centre.
d. Accessories which are subject to normal wear and tear.
5. Liability for direct or indirect consequential losses caused by the unit are excluded even if the damage to the unit is accepted
as a warranty claim.
Living Science Co., Ltd
No.1428, Xiang Jiang Road, Suzhou New District,
Suzhou City 215129, Jiangsu Province, China
Solution
Insert 4 new AAA (LR03) batteries. Insert the
batteries correctly according to the instructions.
Please apply the cuff properly according to the "Cuff
Application Instructions". Measure it again in the
correct way.
Check the connection of the air hose. Repeat the
measurement.
Switch the device off and on again. Then repeat the
measurement.
Wrap the cuff properly. Remeasure in correct way.
Do not speak or move during the measurement.
Wrap the cuff properly. Remeasure in correct way.
Do not speak or move during the measurement.
Wrap the cuff properly.
Remeasure in correct way.
AAA "LR03" alkaline battery
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Questions and answers