Sanitas MD3600 User manual

MD3600
Blood pressure monitor
Instructions for use

2
Content
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
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
pressure, save the measured values and display the deve-
lopment and average values of the measured values taken.
You are also warned of possible existing cardiac arrhythmia.
The recorded values are classified according to the WHO
guidelines 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
ENGLISH
1. Getting to know your device
2. Important notes
3. Unit description
4. Preparing the measurement
5. Measuring blood pressure
6. Evaluating results
7. Saving, displaying and deleting measured values
8. Transferring measured values
9. Error messages/troubleshooting
10. Cleaning and storing the unit
11. Technical specifications
12. Warranty / service
13.
FCC statement

3
Application part, type BF
Direct current
Disposal in accordance with the Waste
Electrical and Electronic Equipment EC
Directive – WEEE
Manufacturer
Storage
RH <93%
-25°C
70°C
Permissible storage temperature and
humidity
Oper ating
5°C
40°C
RH 15-93 %
Permissible operating temperature and
humidity
Protect from moisture
SN Serial number
0123
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 five minutes.
• If you want to perform several measurements on the same
person, wait five minutes between each measurement.
• Do not take a measurement within 30 minutes of eating,
drinking, smoking or exercising.
• Repeat the measurement if you are unsure of the meas-
ured value.
• The measured values taken by you are for your informa-
tion only – they are no substitute for a medical examina-
tion. Discuss the measured values with your doctor and
never base any medical decisions on them (e.g. medi-
cines and their administration).
• Do not use the blood pressure monitor on newborns or
patients with pre-eclampsia. 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 accu-
racy. The same also applies to very low blood pressure,
diabetes, circulatory disorders and arrhythmias as well as
chills or shaking.

4
•The blood pressure monitor must not be used in connec-
tion with a high-frequency surgical unit.
• Only use the device on people who have the specified
upper arm measurement for the device.
• Please note that when inflating, the functions of the limb
in question may be impaired.
• During the blood pressure measurement, the blood circu-
lation 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 flow
may cause injury.
• Make sure that the cuff is not placed on an arm in which
the arteries or veins are undergoing medical treatment,
e.g. intravascular access or intravascular or therapy, or an
arteriovenous (AV) shunt.
• Do not use the cuff on people who have undergone a
mastectomy.
• Do not place the cuff over wounds as this may cause fur-
ther injury.
• The blood pressure monitor can only be operated with
batteries.
• To conserve the batteries, the blood pressure monitor
switches off automatically if no buttons are pressed for
one minute.
• 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
electronic 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 fluctuations and direct sunlight.
– Do not drop the device.
– Do not use the device in the vicinity of strong electro-
magnetic fields and keep it away from radio systems or
mobile telephones.
– Only use the cuff included with the delivery or original
replacement parts. Otherwise incorrect measured values
will be recorded.
• Do not press the buttons before the cuff is placed on the
arm.
• We recommend that the batteries be removed if the de-
vice will not be used for a prolonged period of time.

5
Notes on batteries
• Swallowing batteries can be extremely dangerous. Keep
the batteries and products out of the reach of small
children. If a battery is swallowed, seek medical attention
immediately.
• Batteries must not be recharged, taken apart, thrown into
an open fire or short circuited.
• If the batteries are empty or you do not intend to use the
device for longer periods, remove the batteries from the
device. This prevents damage which could occur due to
leakage. Always replace all batteries at the same time.
• Do not use different types of batteries, different brands or
batteries with different capacities.
For preference, use alkaline batteries.
Instructions for repairs and disposal
• Batteries do not belong in household waste. Please dis-
pose of empty batteries at the collection points intended
for this purpose.
• Do not open the device. Failure to comply will result in
voiding of the warranty.
• Do not repair or adjust the device yourself. Proper opera-
tion can no longer be guaranteed in this case.
• Repairs must only be carried out by Customer Services
or authorised suppliers. Before making a claim, please
check the batteries first and replace them if necessary.
• Please dispose of the device in accordance with
EC Directive – WEEE (Waste Electrical and
Electronic Equipment).
If you have any questions, please contact the local
authorities responsible for waste disposal.

6
3. Unit description
1. Cuff
2. Cuff line
3. Cuff connector
4. START/STOP button
5. Function buttons -/+
6. WHO scale
7. Connection for cuff connector
8. Display
9. Memory button M
10. Setting button SET
Information on the display:
1. Time and date
2. Systolic pressure
3. Diastolic pressure
4. Calculated pulse value
5. Cardiac arrhythmia symbol
6. Battery replacement symbol
7. Memory display: average value ( ), eve-
ning ( ), memory space number
8. Release air
9. WHO classification
10. User memory
11. Symbol for Bluetooth
®
transfer
M
SET
Bluetooth®
SMART
WHO
mmHg
S YS
mmHg
DIA
/min
PUL
8
7
6
410
5
9
2
1
3
1
10
9
8567
2
3
4
11

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System requirements for the “Sanitas HealthCoach” app
Bluetooth
®
4.0, iOS from Version 7.0, Android
TM
devices from
Version 4.3 with Bluetooth
®
Smart Ready
List of compatible devices:
4. Preparing the measurement
Inserting the batteries
• Open the battery compart-
ment lid.
• Insert four 1.5V AA (alkaline
type LR6) 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 briefly displayed, 24 h flashes
in the display. Now set the date, time and Bluetooth
®
as
described below.
If the low battery indicator is permanently displayed,
you can no longer perform any measurements and must re-
place the batteries. Once the batteries have been removed
from the device, the time must be set again.
Used batteries should not be disposed of in normal
household waste. Dispose of them via your electronics re-
tailer or your local recycling point. You are legally obligated
to do so.
Note: The codes below are printed on batteries containing
harmful substances: Pb: battery contains lead, Cd: battery
contains cadmium, Hg: battery contains mercury.
Setting the hour format, date, Bluetooth
®
and time
It is essential to set the 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.
To set the date, Bluetooth
®
and time, proceed as follows:
• Insert the batteries, or press and hold the setting button
SET for at least 5 seconds if the batteries have already
been inserted.
• Select 12h or 24h mode using the +button. Confirm with
SET The year starts flashing. Set the year with the + but-
ton and confirm with
SET .
• Set the month, day, hour and minute and confirm each
with the
setting button SET .
4 x AA (LR6) 1,5 V

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• The Bluetooth
®
symbol is shown in the display, “On” or “Off”
flashes at the same time. With the function buttons “-/+”,
choose whether automatic Bluetooth
®
data transfer should
be activated (“On” flashes) or deactivated (“Off” flashes) and
confirm with the setting button SET .
•If Bluetooth® is activated (“ON”), the data transfer will start
automatically after the measurement.
Bluetooth
®
transfers will reduce the service life of the
battery.
.
5. Measuring blood pressure
Ensure the device is at room temperature before measuring.
Attaching the cuff
Place the cuff on to the bare left
upper arm. The circulation of the
arm must not be hindered by tight
clothing or similar.
The cuff 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
points to the centre of the palm.
Now tighten the free end of the cuff,
but make sure that it is not too tight
around the arm and close the
hook-and-loop fastener. The cuff
should be fastened so that two
fingers fit under the cuff.
Now insert the cuff line into the
connection for the cuff connector.
Important: The unit may only be operated with the original
cuff. The cuff is suitable for an arm circumference of 22 to
36 cm.
✔
✘
Please ensure that the cuff is not bent at any point and
that the reinforced end lies flat against your arm.

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Adopt the correct posture
• Before every measurement, relax for about five minutes.
Otherwise deviations can occur.
• You can take the measurement while sitting or lying.
Always make sure that the cuff is at heart level.
• To carry out a blood pressure measurement, make sure
you are sitting comfortably with your arms and back lean-
ing 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.
Selecting memory
Press the setting button SET. Select the desired user me-
mory ( ... ) by pressing the -/+ function buttons.
You have 4 memories, each with 30 memory spaces to store
the measurements of 4 different people separately. Confirm
your selection with the START/STOP button or wait for
Performing the blood pressure measurement
• As described above, attach the cuff and adopt the pos-
ture in which you want to perform the measurement.
• Start the blood pressure monitor with the START/STOP
button . After the full-screen display, the most recently
stored measurement appears. If there is no measurement
in the memory, the unit displays the value “0”.
• The cuff automatically inflates. The cuff’s air pressure is
slowly released. If you already recognise a tendency for
high blood pressure, you should reinflate the cuff and
increase the cuff’s pressure again. As soon as a pulse is
found, the pulse symbol will be displayed.
• The systolic pressure, diastolic pressure and pulse rate
measurements are displayed.
• You can cancel the measurement at any time by pressing
the START/STOP button .
• _ appears if the measurement has not been performed
properly. Observe the chapter on error messages/trou-
bleshooting in these instructions for use and repeat the
measurement.
• The measurement is automatically stored.
• To switch off, press the START/STOP button . If you
forget to switch off the device, the device switches itself
off automatically after approx. 1 minute.

10
If Bluetooth® data transfer has been activated, the data is
transferred. The blood pressure monitor shows the Bluetooth®
symbol during data transfer. Switch off the blood pressure
monitor by pressing the START/STOP button again. Please
note that to transfer data to the “Sanitas HealthCoach” app,
you must add the blood pressure monitor under “My devices”.
The “Sanitas HealthCoach” app must be active to allow data
transfer. If the latest data is not displayed on your smartphone,
repeat the data transfer as described in chapter 8.
If you forget to turn off the blood pressure monitor, it will
switch off automatically. In this case too, the value is stored
in the selected user memory and the data is transferred if
Bluetooth® data transfer has been activated. The Bluetooth®
symbol appears on the blood pressure monitor display during
data transfer.
During the data transfer, no button function can be performed.
Wait at least 5 minutes before taking another 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 an illness in
which the heart rhythm is abnormal because of flaws in
the bioelectrical system that regulates the heartbeat. The
symptoms (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 measurement 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.
WHO classification:
In accordance with the guidelines/definitions of the World
Heath Organization and the latest findings, the measure-
ments can be classified and assessed according to 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 classified as dangerous.

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The bar chart 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
WHO categories (e.g. systole in the ‘High normal’ category
and diastole in the ‘Normal’ category), the graphical WHO
classification on the unit always shows the higher category;
for the example given this would be ‘High normal’.
7. Saving, displaying and deleting measured
values
The results of every successful measurement are stored
together with the date and time. If there are more than
• Press the setting button SET.Select the desired user
memory ( ... ) by pressing the -/+ function buttons.
Confirm your selection with the START/STOP button .
• M, the average value of
all the stored measured values in the user memory will be
displayed. If you press the memory button Magain, the
average value of the morning measurement for the last
). If you continue to press the memory button M, the
average value of the evening measurements for the last
M, the
most recent individual measured values will be displayed
with the date and time.
• To switch off, press the START/STOP button .
•
If you forget to switch off the device, it will switch itself off
automatically after 1 minute.
• If you want to delete the whole memory for a specific
user, press the memory button M. Press and hold down
both function buttons -/+ simultaneously for 5 seconds.
Blood pressure value category Systole (in mmHg) Diastole (in mmHg) Action
Level 3: severe hypertension ≥ 180 ≥ 110 seek medical attention
Level 2: moderate hypertension 160 – 179 100 – 109 seek medical attention
Level 1: mild hypertension 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

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8. Transferring measured values
Bluetooth
®
Smart transfer
It is also possible to transfer the measured values saved on
the device to your smartphone using Bluetooth
®
Smart. You
will need the “Sanitas HealthCoach” app for this. The app is
available from the App Store.
Proceed as follows to manually transfer values:
Select the memory mode (chapter 7 “Saving, displaying and
deleting measured values”). As soon as the average value
of all the measured values is displayed, a Bluetooth
®
con-
nection is established. The Bluetooth
®
symbol is displayed
during transfer.
More information:
www.sanitas-online.de
9. Error messages/troubleshooting
In the event of errors, the error message _ appears on the
screen.
Error messages may appear if:
• It was not possible to correctly record the pulse: 1 ;
• You speak or move during the measurement: 2 ;
• The cuff 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: 7.
In such cases, repeat the measurement. Ensure that you do
not move or speak.
If necessary, reinsert or replace the batteries.
10. Cleaning and storing the unit
• Clean your blood pressure monitor carefully using a
slightly damp cloth only.
• Do not use any cleaning agents or solvents.
• Under no circumstances should you hold the device
under water, as this can cause liquid to enter and damage
the device.
• If you store the unit, no heavy objects should be placed
on top of it. Remove the batteries. The cuff line should not
be bent sharply.
11. Technical specifications
Model No. MD3600
Measurement
method
Oscillometric, non-invasive blood
pressure measurement on the
upper arm
Measurement
range
Cuff pressure 0-300 mmHg,
Systolic 50-250 mmHg,
Diastolic 30-200 mmHg,
Pulse 40-180 beats/minute

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Display accuracy Systolic ± 3 mmHg,
Diastolic ± 3 mmHg,
Pulse ± 5% of the value shown
Measurement
inaccuracy
Max. permissible standard devia-
tion according to clinical testing:
Systolic 8 mmHg /
Diastolic 8 mmHg
Memory 4 x 30 memory spaces
Dimensions L 139 mm x W 103 mm x H 54 mm
Weight Approximately 267 g (without
batteries and cuff)
Cuff size 22 to 36 cm
Permissible opera -
ting conditions
+5 °C to +40 °C, 15 to 93% relative
humidity (non-condensing)
Permissible sto -
rage conditions
-25°C to +70°C, < 93% relative
humidity, 700-1060 hPa ambient
pressure
Power supply 4 x 1.5 V AA batteries
Battery life For approx. 200 measurements,
depending on levels of blood pres-
sure and pump pressure / Blue-
tooth® transfer
Accessories Instructions for use, 4 x 1.5V AA
batteries, storage pouch
Classification Internal supply, IPX0, no AP
or APG, continuous operation,
application part type BF
Data transfer via
Bluetooth® wire -
less technology
The blood pressure monitor uses
Bluetooth® Smart (low energy),
2.4 GHz frequency band
Technical information is subject to change without notifica-
tion to allow for updates.
• This device complies with European Standard EN60601-
1-2 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
Customer Services address or found at the end of the
instructions for use.
• The device complies with the EU Medical Devices
Directive 93/42/EC, the German Medical Devices Act
(Medizinproduktgesetz) and the standards EN1060-1
requirements), EN1060-3 (non-invasive sphygmoma-
nometers – Part 3: Supplementary requirements for
electro-mechanical blood pressure measuring systems)

14
and IEC80601-2-30 (Medical electrical equipment –
Part 2 – 30: Particular requirements for the basic safety
and essential performance of automated non-invasive
sphygmomanometers).
• The accuracy of this blood pressure monitor has been
carefully checked and developed with regard to a long
useful life. If using the device for commercial medical pur-
poses, it must be regularly tested for accuracy by appro-
priate means. Precise instructions for checking accuracy
may be requested from the service address.
12. Warranty / service
We provide a 3-year warranty covering faults in materials or
manufacture of the product from the purchase date.
The warranty does not cover:
• Damage resulting from improper use.
• Wear parts.
• Defects that were known to the customer at the time of
purchase.
• Damage for which the customer was responsible.
This warranty does not affect the customer‘s legal rights.
The customer must provide proof of purchase in order
for any warranty claims within the warranty period to be
honoured.
Claims under the warranty within a period of 3 years from
the date of purchase are honoured by

13.FCC statement
Changes or modifications to the product not express- ly
approved bythe party responsible for compliance could
void the user’s authority tooperate the equip- ment.
NOTE: This equipment has been tested and found to comply
with the limits for a Class B digital device, pur- suant 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 inter- ference
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 elocate the receiving antenna.
–Increase the separation between the equipment and
receiver.
–Connect the equipment into an outlet on a circuit dif-
ferent from that to which the receiver is connected.
–Consult the dealer or an experienced radio/TV tech-
nician for help.
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MODIFICATION: Any changes or modifications not
expressly approved by the grantee of this device
could void the user’s authority to operate the device.

14.Industry Canada RSS standard
This device complies with Industry Canada RSS standard(s). Operation is subject to the following two conditions:
(1) this device may not cause interference, and
(2) this device must accept any interference, including interference that may cause undesired operation of the device.

Symbol for the marking of electrical and electronics devices according to
Directive 2002/96/EC.
The device, accessories and the packaging have to be disposed of waste
correctly at the end of the usage. Please follow Local Ordinances or
Regulations for disposal.
P/N: 83-M3600-SEN00A-R #0723B
MADE IN CHINA
0123
Shanghai International Trading Corp. GmbH (Hamburg)
Eiffestrasse 80, 20537 Hamburg, Germany.
Grandway Technology (Shenzhen) Limited,
Block 7, Zhu Keng Industrial Zone,
Ping Shan District, 518118 Shenzhen,
PEOPLE’S REPUBLIC OF CHINA