Medisana BU 320 CONNECT Upper Arm Blood Pressure Monitor

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BU 320 CONNECT photo

User Manual BU 320 CONNECT

This is the main product document for model BU 320 CONNECT.

The file format is pdf, 2 pages, you can download this manual here .

background
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.
GB Safety instructions
WARNING - Please ensure that the polythene packing is kept away from the reach of
children! Risk of suffocation!
The unit is intended only for private use in the 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
maintain the device and its accessories according to the user manual. The applied part is the cuff.
This blood pressure monitor is intended for adult use. The device is not suitable for measuring the blood pressure of children
or infants. Ask your doctor before using it on older children.
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.
Before taking a measurement, rest for 5-10 minutes and do not eat, drink alcohol, smoke, do not do any physical work, do
not exercise or bathe. All these factors can inuence 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.
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.
A loose or open cuff causes an incorrect measurement.
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.
The device is not suitable for use on pregnant women, patients with implanted, electronical devices (e.g. pacemaker or
debrillator), patients with pre-eclampsia, premature ventricular beats, atrial brillation, 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
peripheral circulation problems, consult your doctor before using the device.
This device is intended for non-invasive measuring and monitoring of arterial blood pressure on the upper arm. It is not
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 a doctor. If you are taking medication,consult your physician to determine the most appropriate time to measure your
blood 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 difculties in recording a correct reading when measurements are taken using
oscillometric blood pressure devices. This device is electronically equipped to detect irregular heartbeat, which it indicates
with the icon
w
. In this case, contact your physician.
Pay attention during use and storage, that cable and air hose will not cause strangulation. To reduce the risk of strangulation,
keep this product away from children and do not place the hose around the neck.
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 used with surgical equipment at the same time.
Do not apply the cuff over a wound, otherwise it can cause further injury.
If you experience discomfort during a measurement, such as pain in the upper arm or other complaints, press the START/
STOP button
5
to release the air immediately from the cuff. Loosen the cuff and remove it from your arm.
On the rare occasion of a fault causing the cuff to remain fully inated during measurement, open the cuff immediately.
Prolonged high pressure (cuff pressure >300 mmHg or constant pressure >15 mmHg for more than 3 minutes) applied to
the arm may lead to an ecchymosis.
Before use, make sure the device functions safely and is in proper working condition. Do not service or maintain while the
device is in use.
Check the device for damage. The use of a damaged device can result in injury, incorrect readings or serious hazards.
The unit may not be operated in the vicinity of appliances that emit strong electric radiation such as radio transmitters or
mobile phones. This may affect the proper functioning.
The device and its components are suitable for use within the patient environment. If you are allergic to polyester, nylon or
plastic, please don't use this 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
service centres.
Only use original additional or spare parts from the manufacturer. Other parts could damage the device or could lead to
personal injury.
Please report to medisana if any unexpected operation or events occur.
Only use the device under the conditions mentioned in the technical details. Otherwise, the lifespan and performance of the
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
using the device. Before using the device, user should check the appearance of cuff. If you notice blood or other soil on cuff,
please do not use this device. If there is one of above situations, please dispose of the device without reuse.
Protect the appliance from heavy blows and do not drop it.
If the unit is not going to be used for a long period, please remove the batteries.
Accuracy: In case it is needed to have the device checked for calibration, please consult the service center.
BATTERY SAFETY INFORMATION
Do not disassemble batteries!
Renew the batteries when the battery icon appears on the display.
Remove discharged batteries from the device immediately, because they can leak and damage the device!
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!
If a battery has been swallowed seek medical attention immediately!
Replace all of the batteries simultaneously!
Only replace with batteries of the same type, never use different types of batteries together or used batteries with new ones.
Insert the batteries correctly, observing the polarity!
Keep batteries out of children's reach!
Do not attempt to recharge batteries, do not short-circuit and do not throw into a re! 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
collection point, at the shop where they were purchased!
Unit and LC-Display
1
Cuff
2
Air hose
3
Battery compartment (on backside)
4
Connector for the hose
5
START/STOP button
6
M-button
7
"+" button
8
Time (Hours : Minutes)
9
Average of the last 3 measurements
0
Systolic pressure
q
Diastolic pressure
w
Irregular heartbeat
e
Pulse frequency
r
Blood Pressure Indicator (green - yellow - orange - red)
t
Pulse symbol
z
Movement detected / cuff incorrectly applied
u
Battery symbol
i
Measurement unit
o
Bluetooth
®
symbol
p
Date (Month : Day)
Scope of supply
Please check rst 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.
The following parts are included:
1 medisana blood pressure monitor BU 320 connect
1 cuff with air tube
4 batteries (type AAA, LR03) 1.5V
1 storage pouch
1 instruction manual
Please contact your supplier if you notice any transport damage on unpacking the unit.
How is blood pressure measured?
This medisana blood pressure monitor is a device, which is used to measure blood pressure at the upper arm. The measurement
is carried out by a microprocessor - already during the inating process of the cuff. The device detects the systole and the
measurement is completed earlier than using conventional measurement methods. As a result, an unnecessarily excessive
ination pressure in the cuff is prevented.
Blood pressure classication
systolic mmHg diastolic mmHg
Bloodpressure indicator
r
≥ 180 ≥ 110 serious hypertension red
160 - 179 100 - 109 medium hypertension orange
140 - 159 90 - 99 mild hypertension yellow
130 - 139 85 - 89 high-normal blood pressure green
120 - 129 80 - 84 normal blood pressure green
< 120 < 80 optimal blood pressure green
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 trafc)!
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:
1. The warranty period for medisana products is 5 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.
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.
Explanation of symbols
Intended use
This fully automatic over-the-counter electronic blood pressure
monitor is intended for measuring human's systolic and diastolic blood
pressure and heart rate by using an oscillometrique technique by
means of a cuff, which needs to be tted on the upper arm. All values
can be read out in one LCD panel. The useable cuff circumference is
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 symbol.
Contraindication
The device is not suitable for use on pregnant women and patients
with implanted, electronical devices (e.g. pacemaker or debrillator).
IMPORTANT
Non-observance of these instructions can result in serious
injury or damage to the device.
WARNING
These warning notes must be observed to prevent any injury
to the user.
CAUTION
These notes must be observed to prevent any damage to the
device.
NOTE
These notes give you useful additional information on the
installation or operation.
WARNING: To avoid inaccurate results due to electromag-
netic interference, portable RF communication devices
(including peripherals such as antenna cables and external
antennas) should not be closer than 30 cm to any part of the
instrument. The performance of this device may be affected.
Device classication:
type BF applied part
Temperature range Humidity range
Ingress protection rating Atmospheric
pressure range
Non-ionizing electromagnetic radiation
LOT number Serial number
Manufacturer Date of manufacture
SN
IP22
Device information:
Internally powered equipment
Not suitable for use in presence of ammable anesthetic mixture
with air or with oxygen or nitrous oxide
Continuous operation with short-time loading
Inuencing 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 inuenced by several factors. Smoking, consumption of alcohol,
drugs and physical exertion inuence the measured values in various ways.
Measure your blood pressure before meals.
Before taking readings, allow yourself at least ve 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
3
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
u
appears on the display or if nothing appears on the display after the unit has been switched on.
Settings - Setting date and clock
Press the START/STOP button
5
to switch on the device. The device will automatically turn to standby mode. Under standby
mode, press "+" button
7
for 3 seconds, then the year ashes and you can adjust with the M-button
6
. Then press "+" button
again to conrm the entry and to move to the next setting option.
Fitting the cuff
1. Connect the air hose to the connector
4
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 nger (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 ngers 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
7
to select user memory 1 (display: no 1) or 2 (no 2).
Taking a blood pressure measurement
1. After applying the cuff and setting the user memory, press the START/STOP button
5
.
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 inates 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
t
on the display starts to ash. 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. The blood pressure indicator
r
appears next to the relevant coloured bar depending on the blood pressure classication.
6. If the unit has detected an irregular heartbeat, the irregular heartbeat display
w
appears additionally. To stop the
measurement, press START/STOP button
5
. The cuff will deate immediately after the button is pressed.
7. The readings are automatically saved in the selected memory (1 or 2).
8. The measurement results will automatically be transferred via Bluetooth
®
to receive-ready devices, if the function is
activated. During this process, the Bluetooth
®
-symbol p will appear. If Bluetooth
®
is not active, you may manually activate it
by pressing and holding START/STOP button 5 when unit is switched off for approx. 5 seconds, until the Bluetooth
®
-symbol
o appears.
9. After about 1 minute without further operation, the machine switches off automatically.
Transfer via Bluetooth
®
This device offers the possibility to transfer your measured values via Bluetooth
®
to the VitaDock
®
app. The VitaDock
®
app
allows the evaluation, storage and synchronisation of your data between multiple iOS- and Android-devices to have access
to it anytime and anywhere. You may share your results with your friends or your doctor. Therefore you need a free user
account, which you can create on the website www.vitadock.com. For Android or iOS mobile devices, you may download the
respective apps. You will nd a detailed instruction for how to install and use the software on the mentioned website. After each
measurement an automatic transfer of the values will take place (provided that Bluetooth
®
is activated and congurated on the
receiving device).
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
7
to select user memory 1 (display:
no 1) or 2 (no 2). Then press the M-button
6
. The average values of the last 3 measurements
9
appear on the display. If you
now press the M-button
6
again, the last measurement taken appears on the display. Press the M-button
6
again to scroll
through the measured values. By pressing the START/STOP button
5
you can leave the memory recall mode at any time and
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, then press and hold the M- button
6
and the "+" button
7
at the same
time. The memory is cleared ("CLA" appears).
Troubleshooting
Display Cause Solution
No display Batteries do not have enough voltage or are
inserted incorrectly.
Insert new batteries.
Insert the batteries according to the instructions.
E1
Airow abnormally. The air hose may not be
connected correctly.
Check the connection of the air hose. Repeat the
measurement.
EE
Blood pressure too high or too low or effective
pulse too low.
Switch the device off and on again. Then repeat the
measurement in correct way.
E2
Ination pressure over 300 mmHg. Switch the device off and on again. Then repeat the
measurement.
E3
Measurement unsuccessful. Cuff not correctly
applied or movement or speech during
measurement.
Wrap the cuff properly. Remeasure in correct way.
Do not speak or move during the measurement.
Cleaning and maintenance
Remove the batteries before cleaning the unit. Clean the unit using a soft cloth lightly moistened with a mild soapy solution.
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 at 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
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
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 certied
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 specications of EU Guideline “93/42/EEC of the Council Directive dated 14 June 1993 concerning medical
devices” are met.
Technical specications
Contact the customer service.
EP
Name and description:
Display system / Memory slots:
Measuring method / Mode of operation:
Power supply:
Rated cuff pressure:
Measurement pressure:
Pulse measuring range:
Maximum error tolerance for static pressure:
Maximum error tolerance for pulse rate:
Pressure generation:
Deation:
Shelf life (batteries):
Battery life:
Product life span:
Operating conditions:
Storage / Transportation conditions:
Dimensions / Cuff:
Weight (main unit):
Item number:
EAN number:
medisana
Upper arm blood pressure monitor
BU 320 connect
Digital display / 2 x 120
Oscillometric / Continuous operation
4 x 1.5V
AAA "LR03" alkaline battery
0 - 300 mmHg
40 - 280 mmHg
40 - 199 beats per minute
± 3 mmHg
± 5 % of the value
Automatic with pump
Automatic
3 years (Temperature 20 ± 2°C; rel. humidity 65 ± 20 %)
Approx. 250 measurements
Approx. 5 years with 4 times daily use
+5°C to +40°C, 15 to 93 % relative humidity, non-condensing,
700-1060 hPa atmospheric pressure
-25°C to +70°C, relative humidity ≤ 93 %
Approx. 140 x 110 x 56.5 mm / 23 - 43 cm (9" - 17")
Approx. 265 g ± 5 g without batteries
48793
40155 88 48793 4
Motion or speech detected during measurement.
Cuff may not be correctly applied. Measurement
values may be incorrect.
Wrap the cuff properly. Remeasure in correct way.
Do not speak or move during the measurement.
Cuff not correctly applied (e.g. too tight or too
loose).
Wrap the cuff properly.
Remeasure in correct way.
In accordance with our policy of continual product improvement, we reserve the right to make technical and visual
changes without notice.
Upper Arm Blood Pressure Monitor
BU 320 connect
Instruction manual
GB Unit and LC-display
48793_BU 320 connect_manual_GB_TW_202301_L9
3
e
8
t
0
q
z
u
i
9
p
r
w
4
1
5
6
7
2
2-3 cm
(a)
(b)
(c)
2
1
3
o
WARNING
Keep the device at least 20 centimeters away from the human body (especially the head)
when the Bluetooth
®
data transmission is proceeding after measurement.
The distance between the device and the receiver should be between 1 meter to 10 meters
to avoid possible disturbances.
Bluetooth
®
type: 4.2 BLE; System requirements: Android 6.0 or newer; iOS 7.0 or newer
RF Frequency range: 2402 MHz - 2480 MHz; Equivalent isotropic radiant power: 3,99 dBm;
Maximum permitted power: 0,47 mW; Transmitting distance: 10 m (Class 2); Data throughput: 1 Mbps
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
7
to select user memory 1 (display:
no 1) or 2 (no 2). Then press the M-button
6
. The average values of the last 3 measurements
0
appear on the display. If you
now press the M-button
6
again, the last measurement taken appears on the display. Press the M-button
6
again to scroll
through the measured values. By pressing the START/STOP button
5
you can leave the memory recall mode at any time and
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.
Follow the instructions to establish the Bluetooth
®
function. The distance between devices should be less
than 10m. Switch all devices off and after a short waiting
period switch them on again and try to connect again.
Pairing not successful / Bluetooth® not activated
/ Distance between transmitter and receiver too
great / An incompatible device is used / Electrical
or mechanical defect
No
Bluetooth
®-
connection
possible
Bluetooth
®
error. Could not connect to a
connected device for more than 45 seconds.
The Bluetooth
®
function will be disabled.
E4
If you want to reactivate the Bluetooth® function,
press and hold the M-button 6 for about 3 seconds.
0197
background
請在使用本產品之前仔細閱讀本說明書,尤其是安全說明,並保留說明書
以備將來使用。如果您要將本產品轉交給其他人,務必同時移交本說明書。
使用前請務必詳閱原廠之使用說明書並遵照指示使用。
TW 安全說明
警告——請確保將聚乙烯包裝放在
兒童不能接觸的地方!窒息風險!
本產品僅供家庭使用。
僅可根據使用說明將本產品用於其預期用途。如果濫用本產品,保修索賠將失效。
患者是目標操作者。患者可以在正常情況下測量數據和更換電池,並根據用戶說明書維護儀器及其配件。使用的部分
是壓脈帶。
此電子血壓計供成人使用。本產品不適用於測量兒童或嬰兒的血壓。請在用於大齡兒童前諮詢醫師。
請確保將本產品放在兒童和寵物不能接觸的地方。吞咽包裝袋、電池、電池蓋等小零件可能導致窒息。
本產品包含敏感零件。小心操作並確保操作和存放條件符合要求。
在攝入了咖啡因或煙草後,至少要等 30 分鐘才能進行測量。
在測量前,應休息 5 至 10 分鐘,不要進食、飲酒和吸煙,不要做任何體力勞動,不要運動或洗澡。以上這些因素都會
影響測量結果。
反復測量會導致充血,這可能引起測量結果錯誤和/或不適的感覺(如手臂麻木)。連續測量血壓時,每次測量應間隔
3 分鐘。如果症狀在幾分鐘內沒有消退,請聯繫醫師。
始終測量同一側上臂(通常為左臂)。對於做過乳房切除術或淋巴結清除術的患者,建議在非手術側進行測量。
在每日的同一時間定期測量血壓,因為血壓在一天中是波動的。
在測量過程中確保姿勢舒適放鬆,不要緊繃被測手臂的任何肌肉。如有必要,可使用支撐墊。
在測量過程中保持冷靜:不要動或說話,否則測量結果可能會改變。
極端溫度、濕度或高度可能會影響儀器的性能。
壓脈帶鬆動或鬆開會導致測量結果不準確。
若已使用任何其他儀器監測同一個肢體,請勿進行測量。這可能導致干擾或失敗。本產品不適合在四肢靜脈注射或透
析治療期間使用。
本產品不適用於孕婦、植入電子裝置(如心臟節律器或除顫儀)的患者、患有子癇前症、室性早搏、房顫、周圍動脈
疾病的患者和接受血管內治療或動靜脈分流的患者或接受乳房切除術的患者。如果您患有疾病,請在使用本產品之前
諮詢您的醫師。
如果您患有血液循環問題、動脈硬化、糖尿病、肝病、腎病、重度高血壓或周邊血液循環問題,請在使用本產品前諮
詢醫師。
本產品用於無創測量和監測上臂的動脈血壓。本產品不用於上臂以外的其他肢體,也不用於血壓測量以外的用途。
請勿基於自測採取任何治療措施。切勿更改醫師規定的藥物劑量。如果您正在服用藥物,請諮詢醫師以便確定測量血
壓的最佳時間。如果您對本產品測量血壓還有其他問題,請聯繫您的醫師。
在使用示波法血壓計進行測量時,心律不整可能導致難以記錄正確讀數。本產品具有電子設備,可檢測到心律失常,
並以圖標
w
顯示。若出現此情況,請聯繫您的醫師。
在使用和存放過程中請注意,不要被電線和空氣軟管勒住。為降低這一風險,請將本產品放在遠離兒童的地方,不要
將軟管繞在脖子上。
使用時請勿彎曲空氣軟管,否則可能導致受傷。另外,請勿以任何方式擠壓或堵塞空氣軟管。
本產品不能與手術設備同時使用。
請勿將壓脈帶套在傷口上,否則會造成進一步傷害。
如果您在測量期間感覺不舒服,例如上臂疼痛或其他不適,請按 START/STOP(啓動/停止)按鈕
5
讓壓脈帶立即放
氣。鬆開壓脈帶並將其從您的手臂上取下。
在測量期間,如果故障導致壓脈帶保持完全充氣的罕見情況,請立即解開壓脈帶。長時間的高壓(壓脈帶壓力>300
mmHg 或持續壓力 >15 mmHg 超過 3 分鐘以上)施加在手臂上可能會導致瘀斑。
使用前,請確保儀器安全運行並處於正常工作狀態。儀器在使用過程中請勿進行維修或維護。
檢查儀器是否受損。使用受損的儀器可能導致受傷、讀數不準或嚴重危險。
請勿在無線電發射器或移動電話等發出強電輻射的設備附近操作本產品。否則可能影響儀器的正常功能。
本產品及其配件適合在患者環境中使用。如果您對聚酯、尼龍或塑料過敏,請勿使用本產品。
請勿同時接觸電池的輸出端和患者。
若發生故障,請勿嘗試自行維修本產品。只能由授權服務中心執行維修。
僅可使用製造業者提供的原裝附件或備件。其他零件可能會損壞儀器或導致人身傷害。
如果發生任何意外操作或事件,請向原廠報告。
僅在技術詳情中所規定的條件下使用本產品。否則,儀器的使用壽命和性能將受到影響。
如果您患有任何傳染性皮膚病,或者本產品被患有該病的患者使用過,請勿繼續使用本產品。使用儀器前,用戶應先
檢查壓脈帶的外觀。如果發現壓脈帶上有血跡或其他污物,請勿使用本產品。如果出現上述情況之一,請將儀器廢
棄,不再使用。
避免本產品受到重擊,切勿令其摔落。
如果長時間不使用本產品,請取出電池。
準確度:如需對儀器進行校準檢查,請諮詢服務中心。
電池安全訊息
請勿拆解電池!
當螢幕上出現電池圖標時,請更換電池。
立即從儀器中取出放電的電池,因為它們可能會漏液並損壞儀器!
洩漏風險增加,避免接觸皮膚、眼睛和黏膜!如果電池酸液接觸其中任何部位,請使用大量的清水沖洗受影響區域並
立即就醫!
如果吞咽了電池,應立即就醫!
同時更換所有電池!
僅更換為相同類型的電池,切勿將不同類型的電池一起使用或新舊混用!
正確插入電池,正負極不要接反!
將電池保管在兒童不能接觸的地方!
請勿嘗試為電池充電,請勿使電池發生短路,以及請勿將電池扔向火中!存在爆炸危險!
請勿將使用過的電池扔進生活垃圾中;應將它們放入危險廢物箱或帶到電池售賣商店的電池收集點!
儀器和液晶螢幕
1
壓脈帶
2
空氣軟管
3
電池盒 (在背面)
4
軟管接頭
5
START/STOP
(啟動/停止)按鈕
6
M-按鈕
7
「+」按鈕
8
時間(小時 :分鐘)
9
最近 3 次測量平均值
0
收縮壓
q
舒張壓
w
心律不整
e
脈搏頻率
r
血壓指標(綠色 - 黃色 - 橙色 - 紅色)
t
脈搏標誌
z
檢測到移動/壓脈帶佩戴不正確
u
電池標誌
i
測量單位
o
Bluetooth
®
標誌
p
日期(月:日)
產品內容物
請首先檢查儀器是否完整以及是否存在任何形式的損壞。如果存在疑問,請勿使用它並聯繫您的經銷商或服務中心。
包括以下零件:
1 馬德保康電子血壓計 1 個帶空氣管的壓脈帶
4 顆電池(AAA,LR03 型)1.5V 1 個收納盒
1 本說明書
如果您注意到未打開包裝的儀器上有任何運輸損壞,請聯繫您的供應商。
血壓是如何測量的?
本產品是一種用於測量上臂血壓的儀器。測量通過微處理器進行——已在壓脈帶充氣過程中進行測量。該儀器能檢測到收
縮壓,比使用傳統測量方法更快完成測量。因而,可防止壓脈帶出現不必要的過高充氣壓力。
警告——過低的血壓就像過高的血壓一樣代表嚴重的健康風險!陣陣眩暈
可能導致危險情況出現(例如在樓梯上或在行駛途中)!
標誌說明
預期用途
• 這款全自動電子血壓計用於測量人體的收縮壓和舒張壓以及心率,通過
佩戴在上臂的壓脈帶震動進行測量。在一塊液晶螢幕上即可看到所有測
量值。壓脈帶可用圍長為 23 至 43 cm。本產品僅供成人在家庭室內使
用。
• 本產品能夠檢測到心律不整,並顯示相應標誌。
禁忌
本產品不適用於孕婦和有植入性電子裝置(如心臟節律器或除顫器)的
患者。
重要
不遵守這些說明可能會嚴重損害或損壞儀器。
警告
必須遵守這些警告說明,以防對用戶造成任何傷害。
小心
必須遵守這些說明,以防對儀器造成任何損壞。
注意
這些說明提供關於安裝或操作的有用附加訊息。
警告:為避免因電磁干擾造成結果不準確,便攜式射頻通信設備
(包括天線電纜和外部天線等外圍設備)與儀器任何部分的距離不
應低於 30 cm。本產品的性能可能受到影響。
儀器分類:
BF 型應用部件
溫度範圍 濕度範圍
外殼保護等級 大氣
非電離電磁輻射
批號 序列號
製造業者 製造日期
SN
IP22
儀器訊息:
• 內部供電設備
• 不適合在混有空氣或氧氣或一氧化二氮的易燃麻醉劑混合物中使用
• 短時間內連續操作
影響及評估讀數
多次測量您的血壓,然後記錄並比較結果。不要從單個讀數得出任何結論。
您的血壓讀數應始終由熟悉您的個人病歷的醫師來評估。定期使用本產品並為您的醫師記錄值時,您應不時拜訪醫師以
讓其瞭解最新情況。
獲取讀數時,請記住,每天的值都會受到若干因素的影響。吸煙、喝酒和強體力活動會以多種方式影響測量值。
在餐前測量您的血壓。
測取讀數之前,請至少休息 5 分鐘。
在正確使用本產品的情況下,如果多次出現收縮壓和舒張壓異常(過高或過低),請通知您的醫師。這也適用於心律不
整或脈搏極弱導致您無法獲取讀數的罕見情況。
開始使用——插入/更換電池
必須插入所提供的的電池,然後才能使用您的儀器。電池盒的蓋子
3
位於儀器的底側。將其打開並取下,然後插入所提
供的 4 AAA/LR03 1.5 V 電池。插入電池時確保極性正確(標記在電池倉內)。關閉電池倉。如果螢幕上出現更換
電池標誌
u
或打開儀器後螢幕上不顯示任何訊息,請更換電池。
設置 - 設置日期和時鐘
START/STOP 按鈕
5
開啟儀器,儀器會自動進入待機模式。於待機模式下,按 "+" 按鈕
7
3 秒,年份閃爍,再按
M-按鈕
7
進行設定。然後再按 "+" 按鈕確認設定,並進行下一個設定選項。
安裝壓脈帶
將空氣軟管連接至儀器左側的接頭
4
處。
1. 通過金屬支架滑動壓脈帶的開口端,確保尼龍搭扣在外側,並且壓脈帶變為圓柱形(圖 1)。
壓脈帶套到您的左上臂。
2. 將空氣管定位在您手臂中間與中指對齊的位置(圖 2)(a)。壓脈帶的下緣應在肘彎上方
2-3 cm (b)。拉緊壓脈帶並扣上尼龍搭扣 (c)。
3. 拉緊壓脈帶末端,使其均勻地包裹住手臂,在壓脈帶和手臂之間留出 2 個手指的空隙。
4. 在您的裸臂上測量血壓。
5. 僅當無法在左臂上使用時才將壓脈帶綁在右臂上。始終在同一手臂上執行測量。
6. 糾正測量坐姿(圖 3)。確保壓脈帶在測量過程中不會滑落,並且印刷的箭頭指向臂彎處。
用戶記憶體設置
本產品具有 2 個獨立用戶記憶體,每個記憶體為 120 個記憶容量。按下「+」按鈕
7
選擇用戶記憶體 1(顯示:no 1)
2(no 2)。
測量血壓
1. 佩戴壓脈帶並設置用戶記憶體後,按
START/STOP
(啟動/停止) 按鈕5
2. 螢幕將顯示所有字符(顯示測試)。此測試可用於檢查螢幕指示是否正確和完整。儀器已為測量做好準備,並顯示「00
」。
3. 然後儀器自動對壓脈帶充氣以便測量您的血壓,螢幕上顯示壓脈帶中不斷上升的壓力。
4. 儀器發現訊號時,脈搏標誌
t
開始在螢幕上閃爍。如果結果確定,儀器會緩慢釋放壓脈帶中的空氣。收縮壓和舒張
壓以及脈搏值出現在螢幕上。
5. 血壓指標
r
在相應的彩條旁邊閃爍,該指標參照血壓分類。
6. 如果儀器檢測到心律不整,將額外出現心律不整顯示
w
。如需停止測量,按下
START/STOP
按鈕
5
。按下按鈕
後,壓脈帶將立即放氣。
7. 讀數會自動儲存在此前選擇的用戶記憶體中(1 或 2)。
8. 如果相關功能已啟動,測量結果將通過 Bluetooth 自動傳輸到可接收的設備上。在此過程中,Bluetooth 標誌
o
將出
現。如果 Bluetooth 未啟動,您可在本產品關閉約 5 秒後,按住
START/STOP
(開始/停止) 按鈕
5
直到 Bluetooth
標誌
o
出現來手動啟動該功能。
9. 如果約 1 分鐘後沒有進一步操作,本產品將自動關機。
通過 Bluetooth
傳輸數據
本產品可以通過 Bluetooth 將您的測量值傳輸到 VitaDock+應用。 VitaDock+應用支持跨多個 iOS 和安卓設備評估、存儲和同
步您的數據,方便您隨時隨地訪問該數據。您可以與朋友或醫師共享您的結果。為此,您需要一個免費的用戶帳戶,您可以在
www.vitadock.com 網站上創建該帳戶。對於安卓或 iOS 移動設備,您可以下載相應的應用。您可以在上述網站上找到關於如
何安裝和使用該軟件的詳細說明。每次測量後,數值都將自動傳輸(前提是已在接收設備上啟動並配置了 Bluetooth)。
無顯示
電池沒有足夠的電壓或者沒有正確插入電池。
插入新電池。根據說明插入電池。
E1
氣流異常。空氣軟管可能沒有正確連接。 檢查空氣軟管的連接。重複測量。
EE
血壓過高或過低,或者有效脈搏過低。 關閉儀器,然後重啟。按正確方式重複測量。
E2
充氣壓力超過 300 mmHg。 關閉儀器,然後重啟。再次測量。
E3
測量不成功。測量時,沒有正確佩戴壓脈帶、
出現了移動或說話。
正確纏繞壓脈帶。按正確方式再次測量。
測量期間請勿說話或移動。
清潔和保養
清潔儀器前,取下電池。使用微微浸潤中性肥皂液的軟布來清潔儀器。切勿使用具有腐蝕性的清潔劑、酒精、石腦油、稀
釋劑或汽油等。切勿將儀器或任何部件浸入水中。小心不要讓主機進水。不要弄濕壓脈帶或嘗試用水清潔壓脈帶。使用乾
布,輕輕擦除可能留在壓脈帶上的任何多餘水分。將壓脈帶展開平放,通風乾燥。不要將本產品暴露在直射陽光下;防
止其沾染灰塵和受潮。不要將本產品暴露在極熱或極冷的溫度下。不使用時將本產品保存在存儲盒中。將本產品存放在清
潔、乾燥的地方。
消毒
1. 如果是在家庭環境中自己使用,除了正常的清潔程序外,每月用市面上購買的棉布蘸上 75% 的酒精擦拭壓脈帶一次,
每次擦拭 30 秒以上來進行消毒。
2. 如果供多人使用(家庭使用),除了正常的清潔程序外,每周用市面上購買的棉布蘸上 75% 的酒精擦拭壓脈帶一次,
每次擦拭 30 秒以上來進行消毒。
3. 清潔/消毒後和使用前,請確保螢幕、儀器或壓脈帶上沒有血跡或污垢。如果有無法擦除的血跡或污垢,請將儀器廢
棄,不再使用。
4. 如果在複雜的環境中(如醫院)或由自己家庭以外的人使用,使用後應更換新的壓脈帶。
廢棄處置
本產品不得隨一般垃圾一起處理。所有使用者都有義務將所有電氣或電子設備(無論它們是否包含有害物
質)上交到收集點,以便按照環保的方式處理。處理本電子血壓計之前,請取下電池。舊電池不得隨家庭
垃圾一起處理,而應送至回收點或商店的電池收集站。有關處理的資訊,請諮詢您的當地政府或供應商。
指南/標準
本電子血壓計符合歐盟針對無創電子血壓計的標準要求。它通過了歐共體指南的認證並攜帶 CE 標誌(符合性標誌)「CE
0197」。本電子血壓計符合歐洲標準 EN 60601-1、EN 60601-1-2、EN 1060-3、EN 1060-4、EN 81060-1、EN
81060-2 EN 80601-2-30。符合歐盟指南「1993 6 14 日有關醫療器械的委員會指令 93/42/EEC」的規範。
技術規格
聯繫客戶服務中心。
EP
稱和描述:
顯示系統/記憶容量:
測量方法/操作模式:
電源:
壓脈帶額定壓力:
測量壓力:
脈搏測量範圍:
最大靜壓容差:
最大脈搏率容差:
壓力產生:
放氣:
保質期(電池):
電池續航時間:
操作環境溫度:
存放溫度:
尺寸/壓脈帶:
重量(主機):
產品編號:
"馬德保康"
手臂式電子血壓計
數字螢幕/2x120
示波法/連續操作
4 顆電池(AAA 型,LR03),1.5 V
0 - 300 mmHg
40 - 280 mmHg
心跳 40 - 199 次/分鐘
± 3 mmHg
值的 ± 5 %
使用泵自動產生
自動
3 年(溫度 20±2°C;相對濕度 65±20%)
250 次測量
溫度 +5°C +40°C,相對濕度 15-93%,非冷凝
700-1060 hPa 大氣壓
溫度 -25°C +70°C,相對濕度 93%
140 x 110 x 56.5 mm mm / 23 - 43 cm (9" - 17")
265 g ± 5 g(不含電池)
48793
測量過程中出現了移動或說話。沒有正確佩戴壓
。測量值可能不准。
正確纏繞壓。按正確方式再次測量。
測量期間請勿說話或移動。
沒有正確佩戴(例如過緊或過鬆)。 正確纏繞壓
按正確方式再次測量。
故障排除
顯示 原因 解決方案
警告
測量後通過 Bluetooth 傳輸數據時,請將儀器與人體(尤其頭部)
保持至少 20 釐米的距離。
本產品與接收器之間的距離應在 1 到 10 米之間,已避免可能的干擾。
Bluetooth 型號:4.2 BLE;系統要求:Android 6.0 或更新系統;iOS 7.0 或更新系統
射頻範圍:2402 MHz - 2480 MHz;等效各向同性輻射功率:3,99 dBm;
最大允許功率:0,47 mW;傳送距離:10 m (Class 2);數據吞吐量1 Mbps
顯示存儲的結果
本產品具有 2 個獨立記憶體,每個記憶體的容量為 120 個記憶位置。結果會自動存儲在用戶選擇的記憶體中。按下「+」
按鈕
7
選擇用戶記憶體 (顯示:no 1) 或 2 (no 2)。然後按下 M-按鈕
6
。螢幕上將顯示最後 3 次測量的平均值
9
。如
果再次按下 M-按鈕
6
,螢幕上將顯示上一次的測量結果。再按一下 M-按鈕
6
,可以滾動瀏覽測量值。按下
START/
STOP
(啟動/停止)
按鈕
5
,您可以立即退出記憶調用模式,同時,儀器會切換到待機模式。如果記憶體中已存滿 120
個測量值,新存入值將覆蓋最早存入的值。
刪除存儲的數據
上述步驟進入記憶調用模式,同時按住 M-按鈕
6
和 「+」按鈕
7
,相關用戶記憶體內資料被清除 (顯示「CLA」)。
按照以下說明建立 Bluetooth
® 功能。儀器間的
距離應小於 10 米。關閉所有儀器,短暫等待後再
次打開,並嘗試重新連接。
配對不成功/Bluetooth ® 未啟動/發射器和接
收器之間距離過大/使用了不兼容的設備/電氣或
機械缺陷
可能沒有
Bluetooth-連接
3
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8
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0
q
z
u
i
9
p
r
w
4
1
5
6
7
2
2-3 cm
(a)
(b)
(c)
2
1
3
o
CCAH22LPA340T0
取得審驗證明之低功率射頻器材,非經核准,公司、商號或使用者均不得擅自變更頻率、加大功率或變更原設計之特性及功
能。低功率射頻器材之使用不得影響飛航安全及干擾合法通信;經發現有干擾現象時,應立即停用,並改善至無干擾時方得
繼續使用。述合法通信,指依電信管理法規定作業之無線電通信。低功率射頻器材須忍受合法通信或工業、科學及醫療用電
波輻射性電機設備之干擾。
E4
Bluetooth 錯誤。無法連接到已連接的儀器,時
間超過 45 秒。Bluetooth 功能將禁用。
如需重新啟動 Bluetooth 功能,請按住 M 按鈕
6 大約 3 秒鐘。
"馬德保康"手臂式電子血壓計
"medisana" Upper Arm Blood Pressure Monitor
衛部醫器陸輸字第001388
說明書
TW 儀器和液晶螢幕
製造業者名稱:Living Science Co., Ltd.
製造業者地址:No.1428, Xiang Jiang Road, Suzhou New District,
Suzhou City 215129, Jiangsu Province, China
醫療器材商名稱: 恆隆行貿易股份有限公司
醫療器材商地址: 114679臺北市內湖區洲子街88號7樓之1
客服專線: 0800-251209
保固和維修條款
如果在保固範圍內提出維修需求,請聯繫您的經銷商或服務中心。如果您必須退回本血壓計,請附上您的收據副本並說明
具體缺陷。以下保固條款將適用:
1. 產品的保固期為從購買之日起的五年。如果有保固維修,則必須通過銷售收據或發票證明購買日期。
2. 如有材料或工藝缺陷,保固期內將予以免費排除。
3. 保固期內的維修不會延長本血壓計或更換零件的保固期。
4. 以下情況不在保固範圍之內:
a.由於使用不當(例如不遵守使用者說明)而導致的所有損壞。
b.由於客戶未經授權的第三方維修或篡改而導致的所有損壞。
c.在從製造業者向消費者運輸或到服務中心的運輸期間出現的損壞。
d.正常磨損的零件。
"馬德保康"手臂式電子血壓計
產品貨號: 48793
型號: HL858A1-B
目錄編號:BU 320 connect
中國製造
48793_BU 320 connect_manual_GB_TW_202301_L9
0197

Specifications

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