Sanitas MD4200 User manual

DIGITAL AUTOMATIC
BLOOD PRESSURE MONITOR
MD4200
Instructions for use
Blood pressure monitor

ENGLISH
Please read these instructions for use carefully and keep them
for later use, be sure to make them accessible to other users
and observe the information they contain.
1. Getting to know your device
Check that the packaging of the Sanitas MD4200 blood pres-
sure monitor has not been tampered with and make sure that
the required contents are present. Before use, ensure that
there is no visible damage to the device or accessories and
that all packaging material has been removed. If you have any
doubts, do not use the device and contact your retailer or the
speciÿed Customer Services address.
The upper arm blood pressure monitor is used to carry out
non-invasive measurement and monitoring of the arterial blood
pressure values in adults.
This allows you to quickly and easily measure your blood pres-
sure, save the measured values and display the development
and average values of the measured values taken.
You are also warned of possible existing cardiac arrhythmia.
The recorded values are classiÿed and evaluated graphically.
Store these instructions for use for future reference and make
them accessible to other users.
2. Important notes
Signs and symbols
The following symbols are used in these instructions for use,
on the packaging and on the type plate for the device and the
accessories:
Attention
Note
Note on important information
Observe the instructions for use
Application part, type BF
Direct current
Disposal in accordance with the Waste Elec-
trical and Electronic Equipment EC Directive
– WEEE
Manufacturer

Stor age
RH ≤93%
-25°C
70°C
Permissible storage temperature and humi -
dity
Oper ating
5°C
40°C
RH 15-93 %
Permissible operating temperature and
humidity
Protect from moisture
SN Serial number
The CE labelling certifies that the product
complies with the essential requirements of
Directive 93/42/EEC on medical products.
Notes on use
• In order to ensure comparable values, always measure your
blood pressure at the same time of day.
• Before every measurement, relax for about ÿve minutes.
• If you want to perform several measurements on the same
person, wait ÿve minutes between each measurement.
• Do not take a measurement within 30 minutes of eating, drin-
king, smoking or exercising.
• Repeat the measurement if you are unsure of the measured
value.
• The measured values taken by you are for your information
only – they are no substitute for a medical examination. Dis-
cuss the measured values with your doctor and never base
any medical decisions on them (e.g. medicines and their
administration).
• Do not use the blood pressure monitor on newborns or pati-
ents with preeclampsia. We recommend consulting a doctor
before using the blood pressure monitor during pregnancy.
• Cardiovascular diseases may lead to incorrect measure-
ments or have a detrimental effect on measurement accura-
cy. The same also applies to very low blood pressure, diabe-
tes, circulatory disorders and arrhythmias as well as chills or
shaking.
• The blood pressure monitor must not be used in connection
with a high-frequency surgical unit.
• Only use the device on people who have the speciÿed upper
arm measurement for the device.
• Please note that when in°ating, the functions of the limb in
question may be impaired.
• During the blood pressure measurement, the blood circulati-
on must not be stopped for an unnecessarily long time. If the
device malfunctions remove the cuff from the arm.
• Avoid any mechanical restriction, compression or bending of
the cuff line.
• Do not allow sustained pressure in the cuff or frequent
measurements. The resulting restriction of the blood °ow
may cause injury.
• Make sure that the cuff is not placed on an arm in which the ar-
teries or veins are undergoing medical treatment, e.g. intravas-
cular access or intravascular therapy, or an arteriovenous (AV)
shunt.
• Do not use the cuff on people who have undergone a mas-
tectomy.
0123

• Do not place the cuff over wounds as this may cause further
injury.
• Please note that data transfer and data storage is only pos-
sible when your blood pressure monitor is supplied with po-
wer. As soon as the batteries are empty, the blood pressure
monitor loses the date and time.
• To conserve the batteries, the blood pressure monitor swit-
-
conds.
• The device is only intended for the purpose described in
these instructions for use. The manufacturer is not liable for
damage resulting from improper or careless use.
Instructions for storage and maintenance
• The blood pressure monitor is made from precision and elec-
tronic components. The accuracy of the measured values and
service life of the device depend on its careful handling:
– Protect the device from impacts, humidity, dirt, marked
temperature °uctuations and direct sunlight.
– Do not drop the device.
– Do not use the device in the vicinity of strong electroma-
gnetic ÿelds and keep it away from radio systems or mobile
telephones.
–
Only use the cuff included with the delivery or original re-
placement parts. Otherwise incorrect measured values will be
recorded.
• Do not press the buttons before the cuff is placed on the
arm.
Notes on handling batteries
•If your skin or eyes come into contact with battery °uid, rinse
the affected areas with water and seek medical assistance.
•Choking hazard! Small children may swallow and choke on
batteries. Store the batteries out of the reach of small child-
ren.
•Observe the plus (+) and minus (-) polarity signs.
•If a battery has leaked, put on protective gloves and clean
the battery compartment with a dry cloth.
•Protect batteries from excessive heat.
•Risk of explosion! Never throw batteries into a ÿre.
•Do not charge or short-circuit batteries.
•If the device is not to be used for a relatively long period,
take the batteries out of the battery compartment.
•Use identical or equivalent battery types only.
•Always replace all batteries at the same time.
•Do not use rechargeable batteries.
•Do not disassemble, open or crush the batteries.
Battery disposal
•
The empty, completely discharged batteries must be disposed
of through specially designated collection boxes, recycling
points or electronics retailers. You are legally required to dis-
pose of the batteries.
•The codes below are printed on batteries containing harmful
substances:
Pb = Battery contains lead,
Cd = Battery contains cadmium,
Hg = Battery contains mercury

Instructions for repairs and disposal
•Batteries do not belong in household waste. Please dispose
of empty batteries at the collection points intended for this
purpose.
• Do not repair or adjust the device yourself. Proper operation
can no longer be guaranteed in this case.
• Repairs must only be carried out by Customer Services or
authorised
suppliers.
• Do not open the device. Failure to comply will invalidate the
warranty.
• For environmental reasons, do not dispose of the
device in the household waste at the end of its useful
life. Dispose of the device at a suitable local collection
or recycling point. Dispose of the device in accordance with
EC Directive – WEEE (Waste Electrical and Electronic Equip-
ment). If you have any questions, please contact the local
authorities responsible for waste disposal.
3. Device description
M1
SYS
mmHg
DIA
mmHg
PUL
/min
M2
123 4 5
7
8
6
1. Cuff
2. Cuff line
3. Cuff connector
4. Display
5. Memory buttons M1 /M2
6. START/STOP button
7. Scale for classifying the measurements
8. Connection for cuff connector (left-hand side)

Information on the display:
1
58 10
2
3
6
9
7
11
12
4
1. Time/date
2. Systolic pressure
3. Diastolic pressure
4. Calculated pulse value
5. Pulse symbol
6. Release air (arrow)
7. Number of memory space/memory display for average
value ( ), morning ( ), evening ( )
8. Classification of measurements
9. Battery display symbol
10. Cardiac arrhythmia symbol
11. User memory
12. Symbol for Bluetooth ® transfer
System requirements for the HealthCoach app
Bluetooth ®4.0, iOS from Version 7.0, Android TM devices from
Version 4.3 with Bluetooth ® Smart Ready
List of co mpatible devices:
4. Preparing the measurement
Inserting the batteries
• Remove the battery compartment
lid on the rear of the device.
•
LR03) batteries. Make sure that the
batteries are inserted the correct
way round. Do not use rechargeable
batteries.
• Close the battery compartment lid
again carefully.
All display elements are brie°y displayed, or °ashes in
the display. Now set the date and time as described below.
If the battery replacement symbol is permanently
displayed, you can no longer perform any measurements and
must replace all batteries. Once the batteries have been remo-
ved from the device, the date and time must be set again. Any
saved measured values are retained.
4 x 1, 5V AAA

Set the hour format, date, time and Bluetooth
® settings
The following section describes the functions and settings
available on the blood pressure monitor.
Hour format ➔Date ➔Time ➔Bluetooth
®
It is essential to set the correct date and time. Otherwise, you
will not be able to save your measured values correctly with a
date and time and access them again later.
If you press and hold the M1 or M2 memory button, you
can set the values more quickly.
Press and hold the START/STOP button for 5 seconds.
Hour format
The hour format now °ashes on the display.
• Select the desired hour format using the
M1/M2 memory buttons and conÿrm with
the START/STOP button .
Date
The year °ashes on the display.
• Select the year using the M1/M2 memo-
ry buttons and conÿrm with the START/
STOP button .
The month °ashes on the display.
• Select the month using the M1/M2 memo-
ry buttons and conÿrm with the START/
STOP button .
The day °ashes on the display.
• Select the current day using the M1/M2
memory buttons and conÿrm with the
START/STOP button .
If you have set the 12h hour format, the month is
displayed before the day.
Time
The hours °ash on the display.
• Select the current hours using the M1/
M2 memory buttons and conÿrm with the
START/STOP button .
The minutes °ash on the display.
• Select the current minutes using the M1/
M2 memory buttons and conÿrm with the
START/STOP button .

23
Bluetooth
®
The Bluetooth
®
symbol flashes on the display.
• Use the M1/M2 memory buttons to select whether
automatic Bluetooth
®
data transfer is activated ( Blue-
tooth
®
symbol flashes) or deactivated ( Bluetooth
®
symbol is not shown) and confirm with the START/
STOP button .
Bluetooth
®
transfers will reduce the battery life.
5. Measuring blood pressure
Ensure the device is at room temperature before measuring.
The measurement can be performed on the left or right arm.
Attaching the cuff
Place the cu˛ on to the bare left upper
arm. The circulation of the arm must
not be hindered by tight clothing or
similar.
The cu˛ must be placed on the upper
arm so that the bottom edge is
positioned 2 – 3 cm above the elbow
and over the artery. The line should
point to the centre of the palm.
Now tighten the free end of the cu˛,
but make sure that it is not too tight
around the arm and close the hook-
and-loop fastener. The cu˛ should be
fastened so that two fingers fit under
the cu˛.
Now insert the cu˛ line into the
connection for the cu˛ connector.
If the measurement is performed on the right upper arm,
the line should be located on the inside of your elbow. En-
sure that your arm is not pressing on the line.
Blood pressure may vary between the right and left arm, which
may mean that the measured blood pressure values are diffe-
rent. Always perform the measurement on the same arm.
If the values between the two arms are significantly di˛er ent,
please consult your doctor to determine which arm should be
used for the measurement.
Important: The unit may only be operated with the original
cu˛. The cu˛ is suitable for an arm circumference of 22 to
A larger cu˛ for upper-arm circumferences of 35 to 44 cm
can be obtained from specialist retailers or from the service
address using order number 163.387.

M1
M2
24
Adopting the correct posture
• Before every measurement, relax for about five minutes.
Otherwise deviations can occur.
• You can take the measurement while sitting or lying down.
Always make sure that the cu˛ is at heart level.
• To carry out a blood pressure measurement, make sure you
are sitting comfortably with your arms and back leaning on
something. Do not cross your legs. Place your feet flat on the
ground.
• To avoid falsifying the measurement, it is important to remain
still during the measurement and not to speak.
Performing the blood pressure measurement
Measurement
As described above, attach the cuff and adopt the po-
sture in which you want to perform the measurement.
• Press the START/STOP button to start
the blood pressure monitor.
All display elements are brie°y displayed.
The blood pressure monitor will begin the
measurement automatically after 3 se-
conds.
You can cancel the measurement at any time by
pressing the START/STOP button .
As soon as a pulse is found, the pulse symbol will be
displayed.
• The systolic pressure, diastolic pressure
and pulse rate measurements are displa -
yed.
• appears if the measurement could not
be performed properly (see chapter 9 "Er -
ror messages/troubleshooting"). Repeat
the measurement.

25
Measurement
• Now select the desired user memory by pressing the
M1 or M2 memory buttons. If you do not select a user
memory, the measurement is stored in the most re -
cently used user memory. The relevant or symbol
appears on the display.
• Press the START/STOP button to switch o˛ the
blood pressure monitor. The measurement is then sto -
red in the selected user memory.
• If the device is not switched o˛ manually, it will switch
o˛ automatically after 3 minutes.
If Bluetooth ® data transfer has been activated, data is
by transferred after having confirmed the user memory by
pressing the pressing the START/STOP button .
• The Bluetooth
®
symbol on the display flashes and the
blue LED lights up. The blood pressure monitor now
attempts to connect to the app for approx. 30 seconds.
• The Bluetooth
®
symbol stops flashing as soon as a
connection is established. All measurement data is
automatically transferred to the app. Once the data
has been successfully transferred, the device switches
o˛. If the data transfer was unsuccessful, the blue LED
goes out and " " appears on the display.
• If a connection to the app cannot be established after
30 seconds, the Bluetooth
®
symbol goes out and the
blood pressure monitor switches o˛ automatically after
3 minutes.
Measurement
Please note that you must add the blood pressure
monitor in "My devices" in the "HealthCoach" app to
enable data transfers. The "HealthCoach" app must
be active to allow data transfer.
If the latest data is not displayed on your smart -
phone, repeat the data transfer as described in
chapter 7.
If you forget to turn o˛ the blood pressure monitor, it will
switch o˛ automatically after approximately 3 minutes. In
this case too, the value is stored in the selected or most
recent user memory and the data is transferred if Blue-
tooth
®
data transfer has been activated.
• Wait at least 5 minutes before taking ano -
ther measurement.
6. Evaluating results
Cardiac arrhythmia:
This device can identify potential disruptions of the heart
rhythm when measuring and if necessary, indicates this after
the measurement with the symbol .
This can be an indicator for arrhythmia. Arrhythmia is a condi -
tion in which the heart rhythm is abnormal because of flaws in
the bioelectrical system that regulates the heartbeat. The sym -
ptoms (skipped or premature heart beats, pulse being slow or
too fast) can be caused by factors such as heart disease, age,
physical make-up, excess stimulants, stress or lack of sleep.

Arrhythmia can only be determined through an examination by
your doctor.
If the symbol is shown on the display after the measure -
ment has been taken, repeat the measurement. Please ensure
that you rest for 5 minutes beforehand and do not speak or
move during the measurement. If the symbol appears
frequently, please consult your doctor.
Self-diagnosis and treatment based on the measurements can
be dangerous. Always follow your GP’s instructions.
Classication of measurements:
The measurements can be classiÿed and evaluated in accor-
dance with the following table.
However, these standard values serve only as a general
guideline, as the individual blood pressure varies in different
people and different age groups etc.
It is important to consult your doctor regularly for advice. Your
doctor will tell you your individual values for normal blood
pressure as well as the value above which your blood pressure
is classiÿed as dangerous.
The classiÿcation on the display and the scale on the unit show
which category the recorded blood pressure values fall into. If
the values of systole and diastole fall into two different cate-
gories (e.g. systole in the ‚High normal‘ category and diastole
in the ‚Normal‘ category), the graphical classiÿcation on the de-
vice always shows the higher category; for the example given
this would be ‚High normal‘.
Blood pressure
value category
Systole
(in mmHg)
Diastole
(in mmHg) Action
Setting 3:
severe hyper -
tension
˝ 180 ˝ 110 seek medical at -
tention
Setting 2:
moderate hyper -
tension
160 – 179 100 – 109 seek medical at -
tention
Setting 1:
mild hyperten -
sion
140 – 159 90 – 99 regular monitoring
by doctor
High normal 130 – 139 85 – 89 regular monitoring
by doctor
Normal 120 – 129 80 – 84 self-monitoring
Optimal < 120 < 80 self-monitoring
Source: WHO, 1999 (World Health Organization)

7. Display and delete measured values
User memory
The results of every successful measurement are stored
together with the date and time. The oldest measurement
is overwritten in the event of more than 60 measure -
ments.
• Select the desired user memory ( ) with the M1 or
M2 memory buttons if the device is switched o˛.
– To view the measurement data for user memory ,
press the M1 memory button.
– To view the measurement data for user
memory , press the M2 memory button.
The average of all measurements appears
on the display.
If Bluetooth ® is activated (the symbol
flashes on the display), the blood pressure
monitor attempts to connect to the app. If
you press the M1 button in the meantime,
the transfer is cancelled and the average
values are displayed. If you press the M2
button, the transfer is cancelled and the
measurement data of user memory
is displayed. The symbol is no longer
shown. The buttons are deactivated as
soon as a connection is established and the
data is transferred.
Average values
Press the M1 button if you have selected
user memory 1.
Press the M2 memory button if you have
flashes on the display.
The average value of all saved measured
values in this user memory is displayed.
• Press the relevant memory button ( M1 or M2 ).
flashes on the display.
The average value of the morning measure -
ments for the last 7 days is displayed (mor -
ning: 5.00 a.m. – 9.00 a.m.).
P ress the relevant memory button ( M1 or M2 ).
flashes on the display.
The average value of the evening measure -
ments for the last 7 days is displayed (eve -
ning: 6.00 p.m. – 8.00 p.m.).

Individual measured values
W hen the relevant memory button ( M1 or
M2 ) is pressed again, the last individual
measurement is displayed (in this example,
measurement 03).
W hen the relevant memory button ( M1 or M2 ) is pressed
again, you can view your individual measurements.
• To switch the device o˛ again, press the START/STOP
button .
You can exit the menu at any time by pressing the
START/STOP button .
Delete the measured values
• To clear the memory of the relevant user memory, you
must first select a user memory.
• Start the retrieval of the average measured values.
A flashes on the display and the average value of all
saved measured values in this user memory is dis -
played.
• Press and hold the memory button M1 or M2 for 5
seconds depending on the user memory you are in.
All the values in the current user memory are
deleted.
Deleting individual measurements
T o clear individual measurements from the relevant user
memory, you must first select a user memory.
• Start the retrieval of the individual measured values.
• Press and hold the memory button M1 or M2 for 5
seconds (depending on the user memory you are in).
• The selected value is deleted. The device briefly dis -
plays CL 00.
• If you would like to delete other values, repeat the pro -
cess described above.
You can switch o˛ the device at any time by pressing the
START/STOP button.
Transfer via Bluetooth
®
Smart
It is also possible to transfer the measured values saved on the
device to your smartphone using Bluetooth
®
Smart.
You will need the HealthCoach app for this. The app is availa -
ble from the App Store.
Proceed as follows to transfer values:
If Bluetooth
®
is activated in the settings menu, the data is
transferred automatically after the measurement. The symbol
appears in the top left of the display (see chapter 4 „Preparing
the measurement“).

Step 1: MD4200
Activate Bluetooth
®
on your device (see chap-
ter 4 "Preparing the measurement“, Bluetooth
®
).
Step 2: "HealthCoach" app
In the HealthCoach app, add the MD4200 under
"Settings/My devices".
Step 3: MD4200
take a measurement.
Step 4: MD4200
data transfer immediately
following measurements.
• If Bluetooth ® data trans-
fer has been activated,
data is by transferred after
having confirmed the user
memory by pressing the
pressing the START/STOP
button .
Step 4: MD4200
Data transfer at a later point:
• Go to memory mode
(chapter 7). Select the
desired user memory. The
Bluetooth
®
transfer starts
automatically.
The HealthCoach app must be active to allow data transfer.
If your smartphone has a protective cover, remove this to ensu-
re that there is no interference during the transfer. Begin the
data transfer in the HealthCoach app.
8. Cleaning and storing the unit
• Clean the device and cu˛ carefully using a slightly damp
cloth only.
• Do not use any cleaning agents or solvents.
• Under no circumstances should you hold the unit under wa-
ter, as this can cause liquid to enter and damage the unit.
• If you store the device, no heavy objects should be placed on
top of it. The cu˛ line
should not be bent sharply.
In such cases, repeat the measurement and/or data transfer.
Ensure that the cu˛ line is correctly attached and that you do
not move or speak during the measurement.
9. Error messages/troubleshooting
In the event of errors, the error message _ appears on the
display.
Error messages may appear if:
• it was not possible to record the pulse:
1 ;
• you move or speak during the measurement:
2 ;
• the cu˛ is fastened too tightly or loosely:
3 ;
• errors occur during the measurement:
4 ;
• the pump pressure is higher than 300 mmHg:
5 ;
• the batteries are almost empty :
6 ;
• the data could not be sent via Bluetooth
®
.

The word mark Bluetooth ® and accompanying logo are
registered trademarks of Bluetooth ®SIG, Inc. Any and all
use of these marks by Hans Dinslage GmbH is done so
under licence. Other trademarks and trade names are the
property of the relevant holder.
10. Technical specifications
Model No. MD4200
Measurement me -
thod
Oscillometric, non-invasive blood
pressure measurement on the upper arm
Measurement range
Display accuracy
Systolic ± 3 mmHg,
diastolic ± 3 mmHg,
pulse ± 5 % of the value shown
Measurement inac -
curacy
Max. permissible standard deviation
according to clinical testing:
Systolic 8 mmHg /
Diastolic 8 mmHg
Memory 2 x 60 memory spaces
Dimensions L 139 mm x W 94 mm x H 48 mm
Weight
236 (without batteries and cuff˛)
Cuff size 22 to 44 cm
Permissible operating
conditions
+5 °C to +40 °C, 15%- 93% relative air
humidity (non-condensing)
Permissible storage
conditions
-25°C to + 70°C, ≤ 93% relative humidity,
700-1060 hPa ambient pressure
Power supply
AAA batteries
Battery life Lasts for approx. 200 measurements
depending on the blood pressure and
inflation pressure as well as the number
of Bluetooth® connections.
Accessories
Cuff˛, instructions for use, storage
pouch
Classification
Internal supply, no AP or APG,
continuous operation, application part
type BF
Data transfer via
Bluetooth® wireless
technology
The blood pressure monitor uses Blu-
etooth
frequency band, compatible with Blue-
tooth 4.0 smartphones/tablets
List of supported smartphones/tablets
Service Life 1 Year
Cuff pressure 0-250 mmHg,
systolic 50-250 mmHg,
diastolic 30-200 mmHg,
pulse 40-180 beats/minute Bluetooth (BLE)
Module operation
frequency:
2402-2480MHz
Maximum Transmit
Power:
0.1dBm

• The accuracy of this blood pressure monitor has been care-
fully checked and developed with regard to a long useful life.
If using the device for commercial medical purposes, it must
be regularly tested for accuracy by appropriate means.
Precise instructions for checking accuracy may be
requested from the service address.
• We hereby guarantee that this product complies with the
European R&TTE Directive 1999/5/EC.
Please contact the specified service address to obtain more
detailed information such as the CE conformity declaration.
• The device complies with the EU Medical Devices Directive
93/42/EC, the German Medical Devices Act
(Medizinproduk-tgesetz) and the standards ISO EN81060-1
(non-invasive sphygmomanometers - Part 1: Requirements
and test methods for non-automatic measurement type),
EN1060-3 (non-invasive sphygmomanometers – Part 3:
Supplementary requirements for electro-mechanical blood
pressure measur-ing systems) and IEC80601-2-30 (Medical
electrical equip-ment – Part 2 – 30: Particular requirements
for the basic safety and essential performance of automated
non-invasive sphygmomanometers).
Technical information is subject to change without notification
to allow for updates.
This device complies with European Standard EN60601-2 and
is subject to particular precautions with regard to
electromagnetic
compatibility. Please note that portable and mobile HF
communication systems may interfere with this unit. More
details can be requested from the stated Custom-er Services
address or found at the end of the instructions for use.

• Instructions for use
• The ME EQUIPMENT or ME SYSTEM is suitable for home healthcare environments and so on.
• Warning：Don’t near active HF surgical equipment and the RF shielded room of an ME system for magnetic resonance imaging,
where the intensity of EM disturbances is high.
• Warning： Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in
improper operation. If such use is necessary, this equipment and the other equipment should be observed to verify that they are
operating normally.
• Warning: Use of accessories, transducers and cables other than those specified or provided by the manufacturer of this
equipment could result in increased electromagnetic emissions or decreased electromagnetic immunity of this equipment and
result in improper operation.”
• Warning：Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should
be used no closer than 30 cm (12 inches) to any part of the Digital Automatic Blood Pressure Monitor (model name: MD4200),
including cables specified by the manufacturer. Otherwise, degradation of the performance of this equipment could result.
• If any：a list of all cables and maximum lengths of cables (if applicable), transducers and other ACCESSORIES that are
replaceable by the RESPONSIBLE ORGANIZATION and that are likely to affect compliance of the ME EQUIPMENT or ME
SYSTEM with the requirements of Clause 7 (EMISSIONS) and Clause 8 (IMMUNITY). ACCESSORIES may be
specified either generically (e.g. shielded cable, load impedance) or specifically (e.g. by MANUFACTURER and EQUIPMENT
OR TYPE REFERENCE).
• If any：the performance of the ME EQUIPMENT or ME SYSTEM that was determined to be ESSENTIAL PERFORMANCE
and a description of what the OPERATOR can expect if the ESSENTIAL PERFORMANCE is lost or degraded due to
EM DISTURBANCES (the defined term “ESSENTIAL PERFORMANCE” need not be used).

This device complies with part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) This device may not
cause harmful interference, and (2) this device must accept any interference received, including interference that may cause
undesired operation.
NOTE: 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 radiate 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.
--Connect the equipment into an outlet on a circuit different from that to which the receiver is connected.
--Consult the dealer or an experienced radio/TV technician for help.
MODIFICATION: Any changes or modifications not expressly approved by the grantee of this device could void the user’s
authority to operate the device.

Appendix I
The Sphygmomanometer (MD4200) is intended for use in the electromagnetic environment specified below.
The customer or the user of the Sphygmomanometer (MD4200) should assure that it is used in such an
environment.
RF emissions
CISPR11
RF emissions
CISPR11
Harmonic emissions
IEC 61000-3-2
Voltage fluctuations/ flicker
emissions IEC 61000-3-3
Group 1
Class B
Class A
Compliance
Emissions test Compliance
Guidance and manufacturer’s declaration - electromagnetic emissions

Appendix II
The Sphygmomanometer (MD4200) is intended for use in the electromagnetic environment specified below. The
customer or the user of the Sphygmomanometer(MD4200) should assure that it is used in such an
environment.
Electrostatic discharge (ESD)
IEC 61000-4-2
±8 kV contact
±2 kV, ±4 kV, ±8 kV, ±15 kV air
±8 kV contact
±2 kV, ±4 kV, ±8 kV, ±15 kV air
Electrical fast transient/burst
IEC 61000-4-4
Power supply lines: ±2 kV Power supply lines: ±2 kV
Surge
IEC 61000-4-5
line(s) to line(s): ±1 kV 100 kHz
repetition frequency
line(s) to line(s): ±1 kV 100 kHz
repetition frequency
Power frequency magnetic field IEC
61000-4-8
N/A: UT is the a.c. mians voltage prior to application of the test level.
Remark *. The EUT do not contain magnetically sensitive components or circuitry. So this test do not need to evaluated.
30 A/m
50Hz/60Hz
30 A/m
50Hz/60Hz
Proximity Magnetic Fields
IEC 61000-4-39
30KHz, CW,8A/m
134.2KHz - PM 2.1KHz, 65A/m
13.56MHz - PM 50KHz, 7.5A/m
N/A
Conduced RF
IEC 61000-4-6
150KHz to 80MHz:
3Vrms
6Vrms (in ISM and amateur radio bands) 80%
Am at 1kHz
150KHz to 80MHz:
3Vrms
6Vrms (in ISM and amateur radio bands) 80%
Am at 1kHz
Voltage dips, short interruptions and
voltage variations on power supply
input lines
IEC 61000-4-11
0% 0.5 cycle
At 0˚, 45˚, 90˚, 135˚, 180˚, 225˚, 270˚ and 315˚ 0
% 1 cycle And 70% 25/30 cycles Single phase:
at 0 0% 300 cycle
0% 0.5 cycle
At 0˚, 45˚, 90˚, 135˚, 180˚, 225˚, 270˚ and 315˚ 0
% 1 cycle And 70% 25/30 cycles Single phase:
at 0 0% 300 cycle
Immunity test IEC 60601-1-2 Test level Compliance level
Guidance and manufacturer’s declaration - electromagnetic Immunity
Radiated RF
IEC 61000-4-3
10 V/m
80 MHz - 2,7 GHz
80% AM at 1 kHz
10 V/m
80 MHz - 2,7 GHz
80% AM at 1 kHz