Welby MD 10544 User manual

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MD 10544
INSTRUCTION MANUAL
WRIST BLOOD PRESSURE MONITOR
12/06 MSN 5002 5595
Item #7221
Two-Year Limited Warranty
Toll Free Customer Care:
1-866-6 -4660
Distributed by MEDION 0366

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DESCRIPTION OF PARTS PACKAGE CONTENTS
5. On/Off button
6. Cuff
7. Memory button
8. Date and time button
1. Display
2. Battery ompartment over
3. Setting button
4. Dual user button
1)
3)
4)
5)
6)
7)
8)
2)
1. Wrist blood pressure monitor
2. Storage ase
3. 2 AAA batteries
4. Instru tion Manual
Measurement method: Os illometri
Measuring range: Blood pressure: 40 ~ 250mmHg
Pulse: 40 ~ 199 beats/min.
Power supply: 2 AAA batteries
Display: LCD
Memory spa es: 2 x 50 measurement results
Pressure build up: Automati by pump
Air release: Automati via one-way valve
Measuring a ura y: +/- 3mmHg pressure indi ator
+/- 5 % pulse frequen y
Operating temperature: 50° F - 104° F, 40 ~ 85% air humidity
Storage temperature: 14° F - 140° F, 10 ~ 95% air humidity
Weight: approx. 0.255 lb (ex luding batteries)
Cuff a ommodation: Suitable for 5-1/8" - 8-3/4"
The devi e was manufa tured in 2006
TECHNICAL DATA

3
Table of contents
INTRODUCTION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
SAFETY INSTRUCTIONS . . . . . . . . . . . . . . . . . . . . . . . . 5
COMPLIANCE WITH FCC RULES . . . . . . . . . . . . . . . . . . . 6
MEDION LIMITED WARRANTY . . . . . . . . . . . . . . . . . . . 7
ABOUT THIS DEVICE . . . . . . . . . . . . . . . . . . . . . . . . . . 8
FIRST OPERATION . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
THE DISPLAY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
BLOOD PRESSURE INDICATOR . . . . . . . . . . . . . . . . . . 11
ATTACHING THE CUFF . . . . . . . . . . . . . . . . . . . . . . . . 12
CORRECT MEASUREMENT . . . . . . . . . . . . . . . . . . . . . . 13
CARRYING OUT MEASUREMENTS . . . . . . . . . . . . . . . . 14
STORING VALUES . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
CLEANING AND MAINTENANCE . . . . . . . . . . . . . . . . . 16
ENVIRONMENTAL PROTECTION/DISPOSAL . . . . . . . . . 17
ERROR MESSAGES . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
GUIDELINES AND MANUFACTURER'S DECLARATION
FOR ELECTROMAGNETIC EMISSIONS (EMC) . . . . . . . . . 19

4
INTRODUCTION
Thank you for the trust you have placed in us!
Congratulations on the purchase of your new wrist blood pressure monitor! We are convinced
that you will be delighted with this modern piece of equipment.
In order to guarantee the optimum operation and performance of this device at all times and
in order to protect your personal safety, we would make the following suggestions:
• Please read these operating instructions thoroughly and follow them and the safety notes
before using the device for the first time!
• Anything done to or with this device may only be undertaken as described in the
operating instructions.
• If you pass on this device to someone else, always include the operating instructions.
Packaging
Your blood pressure monitor is wrapped in packaging to protect it against transportation
damage. Packaging is raw material and can be re-used or recycled.

5
SAFETY INSTRUCTIONS
• Blood pressure measurements should only be interpreted by a physician or a trained
health care professional who is familiar with your medical history. Through regular use of
this device and recording of your measurements, you can keep your physician informed of
the changes in your blood pressure.
• Perform your measurement in a quiet place.You should be seated in a relaxed position.
• Avoid smoking, eating, taking medication, alcohol consumption or physical activity 30
minutes prior to taking a reading. If you are exhibiting signs of stress, avoid taking your
measurement until the feeling subsides.
• Rest 15 minutes prior to taking a reading.
• Remove any constrictive clothing or jewelry that may interfere with the cuff placement.
• Apply the cuff to the proper position on the left wrist. The unit should be located on the
inside of your left wrist with the display panel in view.
• Keep the monitor stable during measurement to achieve an accurate reading. Remain still;
do not talk during the measurement.
• Record your daily blood pressure and pulse readings on a chart.
• Take your readings at the same time, each day (or as recommended by your physician) to
get an accurate indication of change in your true blood pressure.
• Wait a minimum of 15 minutes between readings to allow for the blood vessels to return
to normal. The wait time may vary depending on your individual physiological
characteristics.
• Although such cases are rare, for those with an extremely weak pulse or irregular pulse,
errors may result which prevent proper measurement. If abnormal variations are noticed,
consult with your physician or trained healthcare professional.
• This device is intended for adult use.
• While taking a measurement, you can stop the inflation or deflation process of the cuff at
any time by pressing the ON/OFF button.

6
COMPLIANCE WITH FCC RULES
This equipment has been tested and found to comply with the limits for a Class B digital device,
pursuant to Part 15 of the FCC Rules.
These limits are designed to provide reasonable protection against harmful interference in a
residential installation. This equipment generates, uses, and can radiale radio frequency
energy and, if not installed and used in accordance with the instructions, may cause harmful
interference to radio communications.
However, there is no guarantee that interference will not occur in a particular installation.
If this equipment does cause harmful interference to radio or television reception, which can
be determined by turning the equipment off and on, the user is encouraged to try to correct the
interference by one or more of the following measures:
• Reorient or relocate the receiving antenna.
• Increase the separation between the equipment and receiver.
• Consult the dealer or an experienced radio/TV technician for help.

7
MEDION LIMITED WARRANTY
Medion warrants that the product accompanied by this limited warranty is free from
manufacturing defects in material or workmanship for a period of 24 months from the date of
original purchase. This warranty only applies to the original purchaser of the product. The
limited warranty period also applies to any implied warranties that may exist under applicable
law. Some States do not allow limitations on how long an implied warranty lasts, so the above
limitation may not apply to you.
This limited warranty does not apply to products that have been opened, repaired (except by
Medion or its authorized Service representatives), or otherwise altered. This limited warranty
does also not apply to defects resulting from misuse, abuse, accident, neglect, improper
maintenance or handling.
If you believe the product is defective please return it to Medion in the manner described below
within the limited warranty period. If Medion determines a defect covered by this limited
warranty, Medion will, at its Option, repair or replace the product. This limited warranty
extends to repaired products and replacement products only through the end of the original
limited warranty period.
In no event shall Medion or any of its distributors or resellers be liable for incidental, indirect
or consequential damages relating to the product (including any repaired product or
replacement product) or its use. Some States do not allow the exclusion or limitation of
incidental or consequential damages, so the above limitation and exclusion may not apply to
you.
This limited warranty gives you specific legal rights, and you may have other rights which vary
from State to State.
To make a claim under this limited warranty you must first contact Medion Customer Care using
one of the options below to obtain a return merchandise authorization (RMA) number. Once
you have received the RMA, please return the product as instructed by the RMA. This warranty
does not apply to any products returned to Medion without a RMA.
To obtain a RMA please contact Medion Toll Free Customer Care at:
www.medionusa.com
or
1-866-633-4660

8
ABOUT THIS DEVICE
The device is used to measure blood pressure at the wrist. It is suitable for healthy people above
12 years of age and can be used to make comparative measurements – especially during
sporting activities.
If the values obtained give you cause to be concerned about your
health, seek medical advice.
Do not change your treatment/dosage of medication as a result of the
values unless you have discussed this with your doctor!
When interpreting the values measured, please note that there can be differences in the values
measured at the wrist and arm. However, because the values measured at the upper arm and
wrist undergo the same changes the values measured at the wrist can be used for comparative
measurements.
The blood pressure monitor displays blood pressure (systolic and diastolic values), pulse, date,
time and WHO indicator. The following summary can help you to assess the values you
measure:

9
FIRST OPERATION
1. Remove the cover of the battery compartment in the direction of the arrow.
2) Insert two AAA batteries. Pay attention to the polarity (the negative terminal faces the
spring).
3) Close the battery compartment.
Replace the batteries:
– if the battery icon appears on the display,
– if the display remains blank after pressing the ON/OFF button.
Setting the date and time
Make the settings within 10 seconds; then the display moves to the next setting.
1. Press the button. The current month flashes.
2) Press the button repeatedly to set the current month.
3) Press the button. The day flashes.
4) Press the button repeatedly to set the current day.
5) Press the button. The hour flashes along with the "AM" (for the hours between
00:00 and 11:59) or "PM" (for the hours between 12:00 and 23:59).
6) Press the button repeatedly to set the current hour.
7) Press the button. The minutes flash.
8) Press the button repeatedly to set the current minutes. Date and time have been set.
The flashing bar disappears automatically after 10 seconds.

10
THE DISPLAY
User icon 1 or 2; select the user with the button.
The battery icon appears if the batteries need to be changed.
This symbol appears if the average blood pressure value is shown.
The pulse sign appears when the pulse is displayed.
EE (E1, E2) Error notifications for operating and device errors.

11
BLOOD PRESSURE INDICATOR
The World Health Organization (WHO) and National High Blood Pressure Education Program
Coordinating Committee have developed a blood pressure standard, classifying blood
pressure ranges into 4 stages. This unit is equipped with an innovative blood pressure
classification indicator, which visually indicates the assumed risk level (prehypertension/
stage 1 hypertension/ stage 2 hypertension) of the result for each measurement.
Stage 2 Hypertension (>160/>100 mmHg)
Stage 1 Hypertension (140~159/90~99 mmHg)
Prehypertension (120~139/80~89 mmHg)
Normal (<120/<80 mmHg)
(If one of the above symbols does not appear, you do not have high blood pressure
according to the WHO standards.)

12
ATTACHING THE CUFF
1. Attach the cuff in such a way that it is approx. 0.2 -
0.4 inches away from the palm of your left hand
(see fig. B). Ensure that no articles of clothing are
trapped in the cuff.
2) Hold the lower part of the cuff as shown in fig. C.
Pull down and wrap it around and upwards so that
there is no gap between the cuff and your wrist.
3) Use your thumb to hold the cuff cover while you
wrap it upwards.
4) Wrap the cuff according to the shape of your wrist.
If the cuff is not firmly attached the pressure will
increase and the wrist will become numb. A correct
measurement is then no longer possible.
If for some reason it is not possible to measure using your
left arm, your right arm can be used. In this case, attach
the sleeve as shown in fig. D.

13
CORRECT MEASUREMENT
• Place your elbow on the table or other supporting surface,
and hold your arm so that the cuff is at heart height.
• To measure your blood pressure, sit comfortably on a chair,
take 5 or 6 deep breaths and relax.
• Always measure your blood pressure at the same time each
day!
It is important to measure your blood pressure at home and
at the same time each day so that the blood pressure, which
can change over the course of a day, is recorded properly.
• Inform your doctor of the values measured so that he can
give you proper medical advice.
• Blood pressure measured at the wrist can vary from that
measured at the upper arm. The values may be slightly
different because of the different measurement positions
and the strength of the blood vessels in the wrist and upper arm. In many cases, the
difference for healthy people can be ±10 mmHg of the systolic and diastolic blood
pressure.
Caution is advised for the following types of person: People with high
blood pressure, diabetes, liver disease, hardened arteries, poor
circulation. These persons should only use the device under advice
from their doctor.

14
CARRYING OUT MEASUREMENTS
1. Attach the cuff to your wrist as described above.
2) Press the ON/OFF button. All
indicators are displayed for a few
seconds on the screen; then the screen
shows the time and the most recently
selected memory space.
Measurement starts automatically; the
device inflates the cuff.
If the pressure is too low, the device
pauses and pumps up the cuff again
until it reaches a pressure that is
appropriate for measurement.
3) The measuring process starts when the correct pressure has been reached.
In order to receive an accurate reading, do not move the cuff, your arm or hand muscles
during the measurement process. The device also measures your pulse. The value
displayed will fall during measurement.
If you want to stop the measurement, press the ON/OFF button. The
air is released from the cuff automatically.
If you want to repeat a measurement you should wait at least five
minutes. The air must be completely removed from the cuff.
4) The cuff automatically deflates when the measurement is
complete. The systolic and diastolic blood pressure and the
pulse with the pulse icon appear in the display.
The entry flashes for a few seconds (see next page).
Press the ON/OFF button again to switch off the device.

15
STORING VALUES
This device contains memory storage for up to 2 individual users and . Up to 50
measurements can be stored for each user. You can also display the average values of the
stored measurements.
1. Before measuring, select the user with the DUAL USER button.
2) Take the measurement. When the values are displayed flashes on the screen for
a few seconds.
The measured value is stored in the chosen memory space.
3) Press the MEMORY button repeatedly to display the stored values. These values are
displayed in reverse order with each press of the button. The entry shows the
average value (for this to occur at least two values must be stored).
The date and time are shown successively with a few seconds in between.
The stored values remain saved when the device is switched on/off.
These values are deleted when the batteries are changed.

16
CLEANING AND MAINTENANCE
Notes on maintenance
It is recommended that you check the usability of the unit every three years or after repairs.
According to the "Operating Regulations for Medical Products," a technical measurement
check must take place every 2 years if the device is used for commercial purposes.
Cleaning/storage
Do not clean the device with solvents that contain alcohol. Only use a soft cloth, which may be
moistened, and a mild cleaning agent. Then dry the device carefully.
Store and transport the device in the storage box supplied.
Do not bend the preshaped cuff outwards. The cuff should neither be washed nor dry cleaned.
If the device is not going to be used for long periods, remove the batteries to avoid corrosion.

17
ENVIRONMENTAL PROTECTION/
DISPOSAL
The unit is battery-operated. Do not dispose of dead batteries in the household trash.
After the end of its life, ensure to dispose the product beneficial to the environment.
Do not dispose the product in the household trash.

18
ERROR MESSAGES
Defect Possible cause and solution
EE / E1 / E2 The cuff is not attached correctly. Please refer to the notes in these
instructions.
Movement during measurement. Do not move or speak during
measurement
The device is not able to measure the values appropriately. Take the
measurement again after a 5 minute break.
Contact the service center if the error is indicated repeatedly over a
long period of time.
The batteries are dead. Replace both batteries with 2 new AAA
batteries.
Notice:
If you detect failures on the display or wrong measurements, remove the
batteries and replace them after 1 minute. Wait for 10 minutes and then
turn the unit on again to start measurement.
Be informed, all memory values are automatically deleted once
batteries are changed!

19
GUIDELINES AND MANUFACTURER'S
DECLARATION FOR ELECTROMAGNETIC
EMISSIONS (EMC)
Guidelines and manufacturer's declaration – electromagnetic emissions
Model MD 10544 is designed for operation in an environment as described below: The customer or
user of Model MD 10544 should ensure that it is operated in such an environment.
Interference emission
measurements In line with Electromagnetic environment guidelines
HF emissions
according to CISPR 11 Group 1 Model MD 10544 uses HF energy exclusively for its internal operation. Therefore
its HF emission is very low and it is
unlikely that nearby electronic
devices should suffer interference.
HF emissions
according to CISPR 11 Class B
Emission of
harmonics
according to IEC 61000-3-2
Not applicable
Emission of
voltage fluctuations/flicker
according to IEC 61000-3-3
Not applicable
Model MD 10544 is intended for use in all premises
including residential areas and those that are directly
connected to public supply networks
that also supply buildings that are used for residential
purposes.
Guidelines and manufacturer's declaration – electromagnetic interference immunity
Model MD 10544 is intended for operation in an electromagnetic environment as described below: The customer
or user of Model MD 10544 should ensure that it is operated in such an environment.
Interference immunity tests IEC 60601
test level Pass level Electromagnetic environment – guidelines
Electrostatic discharge (ESD)
according to IEC 61000-4-2 ± 6 kV contact discharge
± 8 kV
air discharge
N± 8 kV
Air discharge
Floors should be of wood or concrete
or laid with ceramic tiles.
If the floor is covered with synthetic
material, the relative
humidity should be at least 30%.
Fast, transient
electrical interference/
bursts
according to IEC 61000-4-4
± 2 kV for supply lines
± 1 kV for input and
output lines
Not applicable The quality of the power supply should
match that of a typical business or
hospital environment.
Voltage surges
according to IEC 61000-4-5 ± 1 kV bipolar voltage
± 2 kV
unipolar voltage
Not applicable The quality of the power supply should
match that of a typical business or
hospital environment.
Voltage drop-outs,
short-term breaks and drops
in supply voltage
according to IEC 61000-4-11
< 5 % VT
(> 95 % drop in VT)
for ½ period
40 % VT
(60 % drop in VT)
for 5 periods
70 % VT
(30 % drop in VT)
for 25 periods
< 5 % VT
(> 95 % drop in VT)
for 5 s
Not applicable The quality of the power supply should
match that of a typical business or
hospital environment. If
the user of Model MD 10544
requires continued operation even if
power supply drop-outs occur,
we recommend supplying Model MD 10544
from an uninterruptible
power supply or a battery
.

20
Magnetic field at the
power frequency
(50/60 Hz)
according to IEC 61000-4-8
3 A/m 3 A/m Magnetic fields at the mains frequency should
match the
typical values found in business or
hospital environments
.
NOTE VTis the mains AC voltage before application of the test level.
Guidelines and manufacturer's declaration – electromagnetic stability
Model MD 10544 is designed for operation in an electromagnetic environment as described below: The customer
or user of Model MD 10544 should ensure that it is operated in such an environment.
Interference immunity
tests IEC 60601 test level Pass level Electromagnetic environment – guidelines
Portable and mobile should not be used closer to
the [appliance or system] than the protection
distance calculated using the equation applicable
for the emission frequency.
Recommended protection distance:
Conducted HF
interference
according to IEC 61000-4-
6
3 Vrms
150 kHz to 80 MHz Not applicable Not applicable
Radiated
HF interference
according to IEC 61000-4-
3
3 V/m
80 MHz to 2.5 GHz 3 V/m d = 1.2 80 MHz to 800 MHz
d = 2.3 800 MHz to 2.5 GHz
where P is the transmitter's nominal output in Watt
(W) according to the information provided by the
manufacturer of the transmitter and
d is the recommended protection distance in
metres (m).
The field strength at all frequencies of stationary
transmitters is, according to an on-site inspection a,
below the pass level b.
Interference may be experienced in the vicinity of
appliances marked with the following symbol.
NOTE 1 The higher value applies at 80 MHz and 800 MHz.
NOTE 2 These guidelines may not apply to all situations. The radiation of electromagnetic waves is influenced
by absorption and reflection from buildings, objects and people.
aThe field strength of stationary transmitters, such as base stations for radio telephones and terrestrial mobile services,
amateur stations, AM and FM radio and television transmitters cannot be determined precisely in theoretical terms. In order to
determine the electromagnetic environment resulting from stationary HF transmitters we recommend an on-site inspection
. If the field determined at the location of Model MD 10544 exceeds the pass level stated above
the Model MD 10544 must be checked for normal operation at each point of use.
If unusual performance characteristics are observed, it may be necessary to undertake additional measures such as
realigning or moving Model MD 10544.
bNot applicable in the frequency range from 150 kHz to 80 MHz.