Grandway Technology MD4300 Digital Automatic Wrist Blood Pressure Monitor User Manual MD4300 manual
Grandway Technology (Shenzhen) Limited Digital Automatic Wrist Blood Pressure Monitor MD4300 manual
Users Manual
MD4300
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 MD4300 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
specied Customer Services address.
The wrist blood pressure monitor is used to carry out non-inva-
sive 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 irregular heartbeat.
The recorded values are classified 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
1. Getting to know your device ............................................... 16
2. Important notes ................................................................... 16
3. Device description .............................................................. 19
4. Preparing the measurement ................................................ 20
5. Measuring blood pressure .................................................. 22
6. Evaluating results ................................................................ 23
7. Display and delete measured values ................................. 24
8. Cleaning and storing the unit ............................................ 27
9. Error messages/troubleshooting ....................................... 27
10. Technical specifications .................................................... 27
Contents
11. Fcc statement ....................................................
30
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 hu -
midity
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 five minutes.
•
If you want to perform several measurements on the same
person, wait ve 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 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
patients with preeclampsia. We recommend consulting a
doctor before using the blood pressure monitor during preg-
nancy.
•
In the case of restricted circulation on the arm as a result of
chronic or acute vascular diseases (including vascular con-
striction), the accuracy of the wrist measurement is limited.
In this case you should avoid using an upper arm blood
pressure monitor.
•
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 unit on people who have the specied wrist
measurement for the device.
0123
Do not mofify this equipment.
•
•
Please note that when inating, the functions of the limb in
question may be impaired.
•
During the blood pressure measurement, the blood circula-
tion must not be stopped for an unnecessarily long time. If
the device malfunctions remove the cuff from the arm.
•
Do not allow sustained pressure in the cuff or frequent meas-
urements. 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.
•
Do not place the cuff over wounds as this may cause further
injury.
•
The blood pressure monitor can only be operated with bat-
teries.
•
If you do not press any buttons within 30 seconds, the blood
pressure monitor switches off automatically to save the bat-
teries.
•If you do not press any buttons within 3 minutes after a
measurement, the blood pressure monitor switches off auto-
matically to save the batteries.
•
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 electromag-
netic elds and keep it away from radio systems or mobile
telephones.
•
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
children.
•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 re.
•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.
The PATIENT is an intended OPERATOR, and comparable
healthy to normal OPERATOR.
•
•While the EQUIPMENT is in use, no serving and maintenance can
be operated.
•All function and basic maintenance like change battery or clean
EQUIPMENT the PATIENT can perform.
•Do not use rechargeable batteries.
•Do not disassemble, open or crush the batteries.
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 au-
thorised
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
1. Scale for classifying the measurements
2. START/STOP button
3. Display
4. Cuff
5. Memory buttons M1 /M2
M1
M2
3
4
2
1
M1
M2
5
Information on the display:
1. Time/date
2. Systolic pressure
3. Diastolic pressure
4. Calculated pulse
value
5.
Irregular heartbeat
symbol
6. Pulse symbol
7. User memory
8. Classication of
measurements
9. Number of memory
space/memory
display for average
value ( ), morning ( ), evening ( )
10. Release air (arrow)
11. Battery display symbol
12. Symbol for Bluetooth® transfer
System requirements for the HealthCoach app
Bluetooth®4.0, iOS from Version 7.0, AndroidTM devices from
Version 4.3 with Bluetooth® Smart Ready
List of compatible devices:
4. Preparing the measurement
Inserting the batteries
•
Remove the battery com-
partment lid on the rear of
the device.
•
-
kaline type 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 briey 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
removed from the device, the date and time must be set again.
Any saved measured values are retained.
The empty, completely discharged batteries must be disposed
of through specially designated collection boxes, recycling
points or electronics retailers. You are legally required to
dispose of the batteries.
The codes below are printed on batteries contain-
ing harmful substances: Pb = Battery contains
lead, Cd = Battery contains cadmium, Hg = Bat-
tery contains mercury.
1
2
3
4
5678
9
10
11
12
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.
All display elements are briey displayed.
Hour format
The hour format now ashes on the display.
•
Select the desired hour format using the
M1/M2 memory buttons and conrm with
the START/STOP button .
Date
The year ashes on the display.
•
Select the year using the M1/M2 memo-
ry buttons and conrm with the START/
STOP button .
The month ashes on the display.
•
Select the month using the M1/M2 mem -
ory buttons and conrm with the START/
STOP button .
Date
The day ashes on the display.
•
Select the current day using the M1/M2
memory buttons and conrm 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 conrm with the
START/STOP button .
The minutes ash on the display.
•
Select the current minutes using the M1/
M2 memory buttons and conrm with the
START/STOP button .
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
Attach the cuff
•
Expose your left wrist. Ensure that the circulation of the arm
is not hindered by tight clothing or similar.
Place the cuff on the inside of your wrist.
•
Close the cuff with the hook-and-loop fastener such that the
upper edge of the device is positioned approx. 1 cm under-
neath the heel of the hand.
•
The cuff must be tted tightly around the wrist, but must not
constrict.
Adopt the correct posture
•
Before every measurement, relax for about five minutes.
Otherwise deviations can occur.
•
You can perform the measurement while
sitting or lying. 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. Make sure to rest your arm
and move it. Always make sure that the cuff is at heart level.
Otherwise significant deviations can occur. Relax your arm
and the palm of your hand.
•
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 pos-
ture in which you want to perform the measurement.
•
Press the START/STOP button to start
the blood pressure monitor.
All display elements are briefly displayed.
The blood pressure monitor will begin the
measurement automatically after 3 sec-
onds.
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 dis-
played.
•
appears if the measurement could not
be performed properly (see chapter 9 "Er-
ror messages/troubleshooting"). Repeat
the measurement.
1 2 3
1 cm
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 off the
blood pressure monitor. The measurement is then
stored in the selected user memory.
•
If the device is not switched off manually, it will switch
off 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 flashes on the display. 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 off.
If the data transfer was unsuccessful, “ ” 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 off automatically after
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 off the blood pressure monitor, it will
switch off automatically after approximately 3 minutes. In
this case too, the value is stored in the selected or most
recently used user memory and the data is transferred
automatically after 3 minutes if Bluetooth ® data transfer
has been activated.
•
Wait at least 5 minutes before taking an-
other measurement.
6. Evaluating results
Irregular heartbeat:
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 irregular heartbeat. Irregular heartbeat
is a condition 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. Irregular
heartbeat 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.
Classication of measurements:
The measurements can be classied and evaluated in accord-
ance with the following table.
However, these standard values serve only as a general guide-
line, 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 classied as dangerous.
The classication 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 classication 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
attention
Setting 2:
moderate hyper -
tension
160 – 179 100 – 109 seek medical
attention
Setting 1:
mild hyper -
tension
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 off.
•
To view the measurement data for user memory ,
press the M1 memory button.
User memory
•
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
ashes 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 for morning measurements 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 ).
Average values
ashes on the display.
The average value of the morning measure-
ments for the last 7 days is displayed (morn-
ing: 5.00 a.m. – 9.00 a.m.).
P
ress the relevant memory button (M1 or M2 ).
ashes on the display.
The average value of the evening meas-
urements for the last 7 days is displayed
(evening: 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 off again, press the START/STOP
button .
If you forget to turn off the blood pressure monitor, it
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 ashes 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.
If Bluetooth ® is activated (the symbol ash-
es on the display), the blood pressure monitor
attempts to connect to the app. When the
symbol is ashing, it is not possible to de-
lete all values from the selected user memory.
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 briey dis-
plays CL 00.
•
If you would like to delete other values, repeat the pro-
cess described above.
You can switch off 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: MD4300
Activate Bluetooth ® on your device (see
chapter 4 "Preparing the measurement“, Blue -
tooth®).
Step 2: "HealthCoach" app
In the HealthCoach app, add the MD4300 under
"Settings/My devices".
Step 3: MD4300
take a measurement.
Step 4: MD4300
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: MD4300
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 en -
sure 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 cuff 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 cuff line
should not be bent sharply.
In such cases, repeat the measurement and/or data transfer.
Ensure that the cuff 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: ;
• you move or speak during the measurement: ;
• the cuff is fastened too tightly or loosely: ;
• errors occur during the measurement: ;
• the pump pressure is higher than 300 mmHg: ;
• the batteries are almost empty : ;
• the data could not be sent via Bluetooth ®.
The word mark Bluetooth ® and accompanying logo are reg -
istered 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. MD4300
Measurement
method
Oscillometric, non-invasive blood pres -
sure measurement on the upper arm
Measurement range
Pulse 40 – 180 beats/minute
Display accuracy Systolic ± 3 mmHg,
Diastolic ± 3 mmHg,
Pulse ± 5 % of the value shown
28
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 78 mm x W 63 mm x H 23 mm
Weight 66.5 g (Without cuff and batteries)
Cuff size 14 to 19.5 cm
Permissible operating
conditions
+ 5°C to + 40°C, 15-93% relative humid -
ity (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
pump pressure as well as the number
of Bluetooth ®
connections.
Accessories Instructions for use, storage box
Classification Internal supply, IP22, no AP or APG,
continuous operation, application part
type BF
Data transfer via
Bluetooth ® wireless
technology
The blood pressure monitor uses
Bluetooth ®
frequency band, compatible with Blue -
tooth 4.0 smartphones/tablets
List of supported smartphones/tablets
Technical information is subject to change without notification
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 Custom-
er Services address or found at the end of the instructions
for use.
•
The device complies with the EU Medical Devices Directive
93/42/EEC, the German Medical Devices Act (Medizinpro-
duktgesetz) and the standards EN1060-1 (non-invasive
EN1060-3 (non-invasive sphygmomanometers – Part 3:
Supplementary requirements for electro-mechanical blood
pressure measuring systems) and IEC80601-2-30 (Medical
electrical equipment – Part 2 – 30: Particular requirements
29
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 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.
Changes or modifications to the product not expressly approved by the party
responsible for compliance could void the user’s authority to operate the
equipment.
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 equiprement gernerates, 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 different from
that to which the receiver is connected.
– Consult the dealer or an experienced radio/TV technician for help.
11. FCC statement
Subject to errors and changes
30
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.
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.
MADE IN CHINA
P/N: 83-M4300-SEN00A-R #1201A
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
PEMS# E3F5-DC75