Tenker U80EH Instruction Manual
Blood Pressure Monitor
(Model: U80EH)
Instruction Manual
Contents
English
Geman
French
Italian
Spalish
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Table of Contents
Introduction
Safety Information
Product Structure
-- Each part name
Battery installation
Setting mode
-- How to set
Proper use of the unit
-- Pre-measurement
-- Common factors of wrong measurement
-- Fitting the cuff
-- Measuring procedure
-- Discontinuing a measurement
-- Memory-recall of measurements
-- Read memory record
-- Memory-clear of measurements
About blood pressure
Exceptional situations
Care and maintenance
Specification
Warranty information
EMC Declaration
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1
Introduction
Your new digital blood pressure monitor uses the oscillometric method
of blood pressure measurement. This means the monitor detects your
blood’s movement through your brachial artery and converts the
movements into a digital reading. An oscillometric monitor does not need
a stethoscope, so the monitor is simple to use.
This automatic blood pressure monitor could measure the systolic
pressure, diastolic pressure and pulse, the components are included
the body, cuff and printed instruction manual. Batteries and adapter are
optional. This unit is intended for the adult using.
Intelligent inflation will reduce the uncomfortable feeling by incorrect
inflation, and shorten the measurement time, prolong the cuff's usage
lifetime.
2x90 sets memory function, each measurement result will be displayed
on the screen, and automatically stored .This unit has blood classification
index, could easy to check your blood pressure.
Please read the manual carefully before you use the unit, and keep the
manual well aſter using.
It is expected to be used at home or in the hospital, intended for people over
12 years old.
2
Safety Information
To assure the correct use of the product, basic safety measures should
always be followed including the warning and the caution listed in the
instruction manual.
Symbol descriptions
The following symbols may appear in this manual, on the label, on the
device, or on it's accessories. Some of the symbols represent standards
and compliances associated with the device and its use.
WARNING: This alert identifies hazards that may cause serious
personal injury or death.
CAUTION: This alert identifies hazards that may cause minor
personal injury, product damage, or property damage.
Type BF applied part
Manufacturer SN Specifies serial number
Authorized Representative in the European Community
(CE Mark: conforms to essential requirements of the Medical Device
Directive 93/42/EEC.
DISPOSAL: Do not dispose this product as unsorted municipal waste.
Collection of such waste separately for special treatment is necessary.
Direct current
Operating instructions
Follow instructions for use
CAUTION: Consult accompanying documents
3
Safety Information
Those who have arrhythmia, diabetes, blood circulation orapoplexy
problem, please use under the physician's instruction.
Contact your physician for specific information about your blood
pressure. Self diagnosis and treatment which use measured results
may be dangerous. Follow the instructions of your physician or licensed
healthcare provider.
Please place on a high place where children can't be touched.
No modification of this equipment is allowed.
Do not modify this equipment without authorization of the manufacturer.
If this equipment is modified, appropriate inspection and testing must be
conducted to ensure continued safe use of equipment.
The cuff hose around neck may cause the suffocation.
The swallowing of small part like packaging bag, battery, battery cover
and so on may cause the suffocation.
Please don't use a dilution agent, alcohol or petrol to clean the unit
Please don't hit heavily or fall down the product from a high place. Use
the right cuff, otherwise it can not work.
Never leave any low battery in the battery compartment since they
may leak and cause damage to the unit.
Please take off the battery if you won't use in 3 months.
Replace the new batteries if the unit display a low battery symbol.
4
Safety Information
Do not mix the old and new batteries.
Do not use a cellular phone near the unit. It may result in operational failure.
Please avoid using in high radiant area in order to make your
measuring data correctly.
Do not use the equipment where flammable gas (such as anesthetic gas,
oxygen or hydrogen) or flammable liquid (such as alcohol) are present.
WARNING:
- Do not dispose of electrical appliances as unsorted municipal waste,
use separate collection facilities.
- Contact you local government for information regarding the collection
systems available. If electrical appliances are disposed of in landfills or
dumps, hazardous substances can leak into the groundwater and get into
the food chain, damaging your health and well-being.
Classification
1. Internally powered equipment;
2. Type BF applied part;
3. Protection against ingress of water: IP22;
4. Not category AP / APG equipment;
5. Mode of operation: Continuous operation;
The user must check that the equipment functions safely and see that
it is in proper working condition before being used.
5
Product structure
Body
Air socket
Display
Month/Date
WHO blood
pressure
lassification
Memory
Low battery
Cuff size and connection
The accessories cuff is M size, for upper-arm circumfernce 22-42cm use.
The cuff is treated as applied part.
Insert the connector with cuff tube into the hole which
is on the leſt side of the device as picture.
(Only provided cuff can be used, can not
change to any other banded cuff).
AC/DC socket
Setting button
Memory button
Start/stop button
Hour/Minute
Value of systolic
Value of diastolic
Value of pulse
per minute
6
Battery installation
Battery installation
Remove the battery cover from the battery compartment,
insert the battery,
- Remove the battery cover as picture showed.
- Insert 4 AA powerful batteries into the compartment
and ensure each battery is in the proper direction.
Low battery and replacement
When power on, the low battery symbol will display once the unit
start to work, and you must replace with new batteries, otherwise the unit
can’t work.
Battery type and replacement
- Please use 4pcs AA identical 1. 5V alkaline batteries.
- Do not use the batteries beyond their expiry date.
- Please remove the batteries if you do not need to use for long time.
WARNING:
Dispose of the battery in accordance with all federal, state and local laws.
To avoid fire and explosion hazard, do not burn or incinerate the battery.
7
Battery installation
Adapter usage (option)
1. When optional AC adapter should comply with the requirement of IEC
60601-1:2005. Furthermore all configurations shall comply with the
requirements for medical electrical systems (see IEC 60601-1-1 or clause 16
of the 3Ed. of IEC 60601-1, respectively). Anybody connecting additional
equipment to medical electrical equipment configures a medical system and
is therefore responsible that the system complies with the requirements for
medical electrical systems. Attention is drawn to the fact that local laws take
priority over the above mentioned requirements. If in doubt, consult your
local representative or the technical service department.
2. When using AC power, to avoid possible damage to the monitor, use only
the exclusive AC adapter that can be purchased from authorized dealers.
Other adapters may vary in output voltage and polarities.
3. Insert the adapter plug into the hole on the backside of the unit as picture.
4. Insert the other side of the adapter into the outlet with 100-240V.
5. To remove the AC adapter, disconnect the adapter plug from the outlet first
and then disconnect the cord from the unit's socket.
Adapter technical features:
Output voltage: 6V ± 5%
Max. output current: At least 600 mA
Output plug polarity: <+> inner
External diameter; 5.5mm 0.1mm
Internal diameter: 2.1mm 0.1mm
8
Setting mode
Note：
- When use AC adapter, the power of battery won't be consumed.
- When suddenly stop during measurement (like the plug off from the
outlet by carelessness), it must be reinserted the plug into the unit, and
restart the measurement
How to set
1. User setting：
Press button SET when power off , the screen will display or , press
button MEM .it will be changed between and , press button SET when
you confirm the user, then it will enter into the year setting mode.
user 1 user 2
2. Year setting:
Continue to above step, the screen will display and flash 20XX, the last
digit of the year will increase 1 when press button MEM each time, you
could choose from 2001 to 2099. Press button SET when you confirm the
year, then it will enter into the month and date setting mode.
Year setting
9
Setting mode
3. Month and date setting
Continue to above step, the screen will display xxMxxD and xxxx, and keep
flashing on month , the digit will increase 1 when press button MEM each
time, you could choose from 1 to 12. Press button SET when you
confirm the month, then it will set the date. Same as the month setting .
each time you press button MEM , the digit will keep changing from 01
to 31. Press button SET when you confirm the date, then it will enter into
the time setting mode.
Month setting
4. Time setting:
Continue to above step, the screen will display xxMxxD and xx:xx, and keep
flashing on the digits of hour, the digit will increase 1 when press button
MEM each time, you could choose from 0 to 23. Press button SET when you
confirm the hour, then the digits of minute start to flash , same as the hour
setting , each time you press button MEM the digits will keep changing from
00 to 59. Press button SET when you confirm the minute, then the total
setting mode is completed.
hour
setting
Measurement
Pre-measurement
minute
setting
10
Date setting
Proper use of the unit
- Please keep quiet for 5-10 minutes, and avoid eating, drinking alcohol,
smoking, exercising and bathing before taking measurement. All these
factors will influence the measurement result.
- Remove any garment that fits closely to your upper arm.
- Always measure on the same arm(normally leſt).
- Take measurement regularly at the same time of every day, as blood
pressure changes even during the day.
Common factors of wrong measurement
- All efforts by the patient to support their arm can increase blood pressure.
- Make sure you are in a comfortable,relax position and do not activate any
of the muscles in the measurement arm during measurement.Use a
cushion for support if necessary.
- If the arm artery lies lower or higher than the heart,a false reading will
be obtained.
Note:
- Only use clinically approved cuffs!
- A loose cuff or a exposed bladder causes false reading.
- With repeated measurements ,blood accumulates in the arm which can
lead to false reading. Consecutive blood pressure measurements should
be repeated aſter 1 minute pause or aſter the arm has been held up in
order to allow the accumulated blood to flow away.
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Proper use of the unit
Fitting the cuff
1. Put the cuff on a table flatly with the velcro side down.
Pass the end of the cuff through the metal loop so that a
circle is formed. The velcro closer will now be facing
outwards (ignore this step if the cuff has already been
prepared)
2. Push the cuff over the leſt upper arm so that the tube
points in the direction of the lower arm.
3. Wrap the cuff on the arm as illustrated. Make certain
that the lower edge of the cuff lies approximately 2 to
3 cm above the elbow and the rubber tube leaves the
cuff on the inner side of the arm.
4. Tighten the free end of the cuff and close the cuff by
affixing the velcro.
5. The cuff should be snug on your upper arm so That
you can fit 2 fingers between the cuff and your upper
arm. Any piece of clothing restricts the arm which must
be taken off.
6. Secure the cuff with the velcro closer in such a way
that it lies comfortably and not too tight. Lay your arm
on a table (palm upwards) so that the cuff is at the same
height as the heart. Do not bend the tube.
Note：
If it is not possible to fit the cuff to your leſt arm, it can
also be placed on the right. However, all measurements
should be made using the same arm.
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Proper use of the unit
Measuring procedure：
Aſter the cuff has been appropriately positioned, the
measurement can begin：
1. Press the START/STOP button, all symbols appear on the
display, you can hear 2 short beep aſter 0 flash for 2 seconds,
then the pump begins to inflate the cuff, the rising pressure
in the cuff is shown on the display.
2. Aſter the suitable pressure has been reached, the pump
stops and the pressure gradually falls. The cuff pressure is
displayed. In case that the inflation is not sufficient, the device
automatically re-inflates to a higher pressure.
3. When the device detects the signal, the heart symbol on
the display starts to flash, you can hear the beep for every
heartbeat once the heartbeat signal is detected.
4. When the measurement has been completed, you can hear a long beep, in
the meantime, the systolic, diastolic and pulse rate will appear on the display.
5. The measurement readings remain on the display until you switch off the
device. If no button is pressed for a period of 3 minutes, the device switches
off itself in order to save the power.
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Proper use of the unit
Discontinuing a measurement
If it is necessary to interrupt a blood pressure measurement for any reason
(eg. the patient feels unwell) the START/STOP button can be pressed at any
time. The device immediately decrease the cuff pressure automatically.
Memory-recall of measurements
This blood pressure monitor automatically stores 2x90 sets measurements
value, the oldest record will be replaced by the latest measurement value
when more than 90 sets each user.
Read memory record
Press the button MEM when power off, the latest 3 times average value
will be shown, press the button MEM again,the last measurement value
will be shown, as well as subsequent measurements can be display one
aſter the other by pressing the button MEM each time.
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About blood pressure
Memory - clear of measurements
If you are sure that you want to permanently remove all stored memories.
Press the button SET for 6 times until CL appears when power off, press the
START/STOP button , CL will flash for 3 times to clear all the memories. Aſter
this press button MEM, and "no" will be shown on the display which
mean that no memory in store.
About blood pressure
Blood pressure is the pressure exerted the arteries. The systolic blood
pressure value represents the blood pressure produced by contraction of the
heart muscle. The diastolic blood pressure value represents the blood
pressure produced by relaxation of the heart muscle.
Systolic blood pressure
Contration of the
heart muscle
Extrude blood
Pressure increased
to the blood vessel
Higher pressure
Diastolic blood pressure
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Relaxation of the
heart muscle
Blood return heart
Pressure decreased
to the blood vessel
Lower perssure
About blood pressure
According to the blood pressure classification by the WHO/ISH.
SYS lower than 100mmHg(13.3kPa) is considered as hypotension.
Diastolic bloo
pressure
(mmHg)
110
100
90
85
Normal blood pressure
80
Optimal blood
pressure(target value)
Blood pressure type
Optimal blood pressure Normal blood pressure High normal value
Severe hypertension
Moderate hypertension
Mild hypertension
High normal value
120 130 140 160 180
Systolic
blood pressure
(mmHg)
Mild hypertension Moderate hypertension Severe hypertension
16
Exceptional Situation
Error indicators
The following symbol will appear on the display when measuring abnormal.
Symbol Cause
Weak signal or
pressure change
suddenly
External strong
disturbance
It appears error
during the
process of
inflating
Abnormal
blood pressure
Low battery
Wrap the cuff properly.
Remeasure with correct way.
When near cell phone or other high radiant
device , the measurement will be failed.
Keep quite and no chatting when measure.
Wrap the cuff properly.
Make sure that the air plug is properly
inserted in the unit.
Remeasure.
Repeat the measurement aſter relax for 30 mins , if get
unusual readings for 3 times,please contact your doctor.
Replace all the worn batteries with new ones.
Trouble removal
Problem Check Cause and solutions
No power
No inflation
Err and stop working
Cuff leak
Please contact the distributor if you can't solve the problem, do not disassemble the unit by yourself!
Check the battery power
Check the polarity position
Whether the plug insert
Whether the plug broken or leak
Whether move the arm when inflate
Check if chatting when measured
Whether the cuff wrap too loose
Whether the cuff broken
Correction
Replace new one
Installation for proper placement
of the batteries polarities
Insert into the air socket tightly
Change a new cuff
Keep the body peaceful
Keep quite when measure
Wrap the cuff tightly
Change a new cuff
17
Care and maintenance
Care for the main unit and blood pressure monitor cuff
- Keep the unit in the storage case when
no use.
- Clean the unit with soſt dry cloth. Do not
use any abrasive or volatile cleaners.
- Never immerse the unit or any component
in water.
- Make sure the monitor is off prior to cleaning, a mixture of
distilled water and 10 percent bleach could be used.
- Using a spray bottle, moisten a soſt cloth towel with the bleach
or detergent mix until it is fully saturated. Squeeze any excess
moisture from the cloth to avoid any dripping or potential
oversaturation of the cuff.
- Wipe all surfaces of the blood pressure monitor cuff thoroughly,
making sure to clean the inside and outside of the cuff. Be cautious
not to get any moisture in the main unit.
Maintenace
Do not clean the body and cuff with
naphtha, thinner or gasoline etc.
Do not wet the cuff or attempt to clean
the cuff with water.
Store the unit in a clean and dry location .
Do not subject the unit to extreme hot or
cold temperature, humidity and direct
sunlight.
* We won’t be responsible for any quality problem if you don't care and maintain the product as instructed.
Remove the batteries if the unit will not be
used in 3 months or longer.
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Specification
Description
Display
Measuring principle
Measuring localization
Measurement range
Accuracy
Measuring localization
Memory function 2x90 sets memory of measurement values
Power source 4pcsAA alkaline battery DC. 6V or AC adapter
Automatic power off In 3 minutes
Main unit weight Approx. 219g (batteries not included)
Main unit size L132mm x W100mm x H45mm
Main unit lifetime 10,000 times under normal use
Battery life Could be used for 300 times for normal condition
Accessories Cuff, instruction manual
Operating environment
Storage environment
Automatic upper arm blood pressure monitor
LCD digital display
Oscillometric method
Upper arm
Pressure
Pulse
Pressure
Pulse
Pressure
Pulse
Symbol Memory/Heartbeat/Low battery
Temperature
Humidity
Air pressure
Temperature -20~55℃, Humidity ：15%~85%RH avoid crash,
sun burn or rain during transportation.
0～299 mmHg (0~39.9kPa)
40~199 pulses/min
±3mmHg (±0.4kPa)
±5% of reading
3 digits display of mmHg
3 digits display
5~40℃:
15%~85%RH
86kPa~106kPa
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Warranty information
Statement
-
The intended use: the unit is intended to be used by adults at home or medical
center to measure blood pressure and pulse rate from the upper arm.
- The unit satisfies the requirements of EN ISO 81060-1 Part 1 Noninvasive
sphygmomanometers, EN 1060-3:1997+A2:2009 Non-invasive
sphygmomanometers. IEC80601-2-30 Part 2 Non-invasive sphygmomanometers.
- Blood pressure measurements determined with this device are equivalent
to those obtained by a trained observer using the cuff/stethoscope
auscultatory method, within the limits prescribed by the American National
Standard, manual, electronic, or automated sphygmomanometers.
- The risk of patient and user can be lowered to acceptable level.
Warranty Information
- The unit is guaranteed to be free of defects in workmanship and materials
under normal use for a period of Two Years from the date listed on the
purchase record.
- For repair under this warranty. Our authorized service agent must be
advised of the fault with the period of the warranty. This warranty covers
parts and labor only under normal operations. Any defect resulting from
natural causes, eg. flood, hurricane etc, is not within this guarantee. This
guaranty does not cover damage incurred. By use of the unit not in accordance
with the instructions, accidental damage, or being tampered with or serviced
by unauthorized service agents.
- Monitor subjected to misuse, abuse, and neglect of these manual content ,
non-instructional purposes; unauthorized repair or modifications will be
excluded from this warranty.
The device requires no calibration.
The device is not repairable and contains no user serviceable parts.
20
EMC Declaration
Guidance and manufacturer's declaration - electromagnetic immunity.
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.
Immunity test
Electrostatic
discharge (ESO)
IEC 61000-4-2
Electrical fast
transient/burst
IEC 61000-4-4
IEC 60601
test level
±6 kV contact
±8kVair
±2 kV for power
supply lines
±1 kVfor
input/output lines
Compliance
level
±6 kV contact
±8kVair
±2 kVfor power
supply lines
±1 kVfor
input/output lines
Electromagnetic
environment - guidance
Floors should be wood,
concrete or ceramic tile. If
floors are covered with
synthetic material, the elative
humidity should be at least 30
Mains power quality should be
that of a typical commercial or
hospital environment.
Surge
IEC 61000-4-5
Voltage dips, short
interruptions and
voltage variations
on power supply
input lines
IEC 61000-4-11
Power frequency
(50/60 Hz)
magnetic field
IEC 61000-4-8
NOTE UT is the a.c. mains voltage prior to application of the test level.
±1 kV differential
mode
±2 kV common
mode
<5 % UT
095 % dip in UT)
for 0,5 cycle
40 % UT
(60 K dip in UT)
for 5 cycles
70%UT
(30 K dip in UT)
for 25 cycles
<5 % UT
095 % dip in UT)
for 5 sec
3A/m 3A/m
±1 kV differential
mode
±2 kV common
mode
<5 % UT
095 % dip in UT)
for 0,5 cycle
40 % UT
(60 % dip in UT)
for 5 cycles
70%UT
(30 % dip in UT)
for 25 cycles
<5 % UT
095 % dip in UT)
for 5 sec
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Mains power quality should be
that of a typical commercial or
hospital environment.
Mains power quality should be
that of a typical commercial or
hospital environment. If the
user of the “blood pressure
monitor” requires continued
operation during power mains
interruptions, it is
recommended that the
Hood pressure monitor” be
powered from an
uninterruptible power
supply or a battery.
Power frequency magnetic fields
should be at levels characteristic
of a typical location in a typical
commercial or hospital
environment.
EMC Declaration
Immunity test
Conducted RF
IEC 61000-4-6
Radiated RF
IEC 61000-4-3
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.
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 blood pressure monitor”
is used exceeds the applicable RF compliance level above, the 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 “blood pressure monitor".
b
Over the frequency range 150 kHz to 80 MHz, field strengths should be less than [V1] V/m.
IEC 60601
test level
3 Vrms
150 kHz to 80
MHZ
3 V/m
80 MHz to 2,5
Ghz
Compliance
level
3 V
3 V/m
Electromagnetic
environment - 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 the
transmitter.
Recommended separation distance
d=1.2VP
d=1.27P 80MHzto800MHz
d=2.3 JP 800MHz 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,
should be less than the compliance
level in each frequency range.
Interference may occur in the
vicinity of equipment marked with
the following symbol:
a
b
22
EMC Declaration
Guidance and manufacturer's declaration - electromagnetic emissions
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.
Emissions test Compliance Electromagnetic environment - guidance
The '‘blood pressure monitor” uses RF energy only
RF emissions
CISPR11
RF emissions
CISPR11
Harmonic emissions
I EC 61000-3-2
Voltage fluctuations/
flicker emissions
I EC 61000-3-3
Group 1
Class B
ClassA
Complies
for its internal function. Therefore, its RF emissions
are very low and are not likely to cause any
interference in nearby electronic equipment.
The “blood pressure monitor" is suitable for use
in all establishments, including domestic
establishments and those directly connected to
the public low-voltage power supply network that
supplies buildings used for domestic purposes.
23
EMC Declaration
Recommended separation distances between portable and mobile RF
communications equipment and the blood pressure monitor.
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
output power of
transmitter
W
eparatlon distance according to frequency of transmitter
150 kHz to 80 MHZ 80 MH to 800 MHZ 800 MHz to 2,5 Ghz
m
0,01
0.1
1
10
100
0.12
0.38
0.12
1.2
3.8
12
0.38
1.2
3.8
12
0.23
0.73
2.3
7.3
23
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.
24
Blutdruckmessgerät
(Model: U80EH)
Operation Manual
Inhaltsverzeichnis
Einleitung
Sicherheitsinformationen
Produktaufbau
--Beschreibung der Bestandteile
Installation der Batterie
Einstellungsmodus
--Einstellungen vornehmen
Richtige Verwendung des Geräts
--Vor der Messung
--Übliche Faktoren für Fehlmessungen
--Binde anbringen
--Messverfahren
--Messung abbrechen
--Speicherfunktion für Messungen
--Speicher auslesen
--Gespeicherte Messungen löschen
Über den Blutdruck
Ausnahmesituationen
Pflege und Wartung
Eigenschaſten
Garantieinformationen
EMC Erklärung
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