Geratherm GP-6621 User Manual

Digital Blood Pressure Monitor

for the Upper Arm

INSTRUCTION FOR USE

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Contents

Designated Use ............................................. 24

Precautions .................................................... 25

Warranty ......................................................... 27

Information You Should Know

Before Operating the Unit ............................ 27

About the Unit

Explanation of Display ................................. 28

Preparation for Use

Installing/Replacing Batteries ...................... 29

Attaching the Pressure Cuff ......................... 30

Measuring Posture ....................................... 30

How to Operate the Unit

Setting the Clock .......................................... 31

Measuring Blood Pressure .......................... 31

Recalling Memories ..................................... 32

Erasing Memories ........................................ 33

Care and Maintenance ................................... 34

Error Message ................................................ 36

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Disposal .......................................................... 36

Specifi cations ................................................. 37

Quality Standard ............................................ 38

Symbol Index .................................................. 38

Annex .............................................................. 39

Designated Use

This unit uses an oscillometric measurement method in
order to measure systolic and diastolic blood pressure, as
well as the heart rate.
The measurement is conducted on the upper arm.
All values can be read on an LCD screen.
This unit has been developed for home and professional
use and should only be used by adults over 18 years of age
with an arm diameter of 22 ~ 32 cm / 8.7 - 12.6 inches.

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Precautions

• This manual and the product are not substitutes for
visiting the doctor.

Neither the information contained herein nor this prod-

uct may be used to diagnose or treat health problems,
or to prescribe drugs. If you have or suspect that you
have a medical problem, please seek immediate ad­vice from your doctor.

• Do not conduct any measurements if the temperature
is low (below +5 °C) or high (over +40 °C), or if the
relative humidity is beyond the range of 15 % to 90 %,
as this can lead to inaccurate readings.

• Wait 30 to 45 minutes, before taking a measurement if
you have just had a caffeinated drink or a cigarette.

• Relax for at least 5 to 10 minutes before taking a
measurement.

• Please wait 3 to 5 minutes between measurements,
so that your blood vessels can return to the state they
were in prior to measurement. You may have to adapt
the waiting time to your personal physiology.

• It is recommended that you use the same arm for each
measurement (preferably the left) and take the meas­urement at about the same time every day.

• Sit down comfortably with your elbows placed on the
table and both feet on the ground. Please do not inter­lock your legs during the measurement.

• Place the unit at the level of the heart. Relax your
hand. Your palm should be facing up.

• Take the measurement at room temperature in a quiet
and stress-free environment.

• The unit should not be moved or shaken during the
measurement. Please do not speak during the meas­urement.

• Please keep in mind that blood pressure naturally
varies depending on the time of day and is affected
by many different factors. Blood pressure is usually
highest at work and reaches its lowest level during the
sleep phase.

• Blood pressure measurements should be assessed
by a doctor or trained healthcare professional who is
familiar with your medical history. If you use the unit
and regularly record the results, please keep your
doctor informed with regard to the ongoing changes
in your blood pressure.

• If you suffer from a cardiovascular disease (such as
atherosclerosis), diabetes, a liver or kidney disease,

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Precautions

severe hypertension or peripheral circulatory disor­ders, etc., please consult your doctor before using this
unit.

• The performance of this device can be infl uenced as
severe arrhythmias such as atrial or ventricular pre­mature beats or atrial fi brillation are presented during
measurement.

• The blood pressure measurements conducted with
this unit are equivalent to measurements obtained
by a trained observer in accordance with the values
achieved using the cuff/stethoscope auscultation
method and are within the specifi ed EN 1060-4 stand-
ard limits.

• If the cuff causes any discomfort during the measure­ment, press the “POWER” button to turn off the unit
immediately.

• If the pressure is over 300 mmHg and the cuff does
not defl ate automatically, pull off the Velcro strap to
detach the cuff.

• Do not use this appliance on infants, children or per­sons who cannot express their own intentions.

• To avoid accidental strangulation, keep the product
away from children and do not place the hose around
the neck.

• Measuring too frequently may result in circulatory dis-

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orders, which can cause unpleasant sensations such
as localised bleeding under the skin or temporary
numbness in your arm. These symptoms do not usu­ally last long. However, if you have not recovered after
some time, please consult your doctor.

• Please take into consideration the electromagnetic
compatibility of the unit (e.g. disruptions to the power
supply, radio frequency interference, etc.) see annex.
Please only use the unit indoors. To avoid inaccurate
results due to electromagnetic interference between
electrical and electronic equipment, please do not use
the unit near mobile phones or microwave ovens. In
the case of devices whose maximum power exceeds
2 W, the minimum distance from your blood pressure
monitor should be 3.3 metres.

• The unit is not waterproof. Never immerse this instru­ment in any liquids.

• Do not use the instrument if you think it is damaged or
if you notice anything unusual.

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Warranty

The warranty for this blood pressure monitor is valid for any
error on the part of the manufacturer under normal use for
3 years from the date of purchase. If your unit does not
function properly due to defective parts or assembly, we
will repair it free of charge.
With the exception of the battery and cuff, all parts of the
unit are subject to this warranty. Damage caused by im­proper handling of your unit is not guaranteed.
We recommend that the accuracy of the unit be checked
after 2 years from manufacturing date by an authorized

laboratory.
This checking procedure is not a service provided under
the warranty.

Information you should know
before operating the unit

What is blood pressure?

A force is created by the heart as the ventricle forcibly
ejects blood into the blood vessels and through the trans­port system. Another force is created by the arteries as they
resist the blood fl ow. Blood pressure is the result of these
two forces.

What are systolic and diastolic pressures?

Systolic pressure represents the highest pressure at the

height of the heart‘s contraction. Diastolic pressure is the

lowest pressure when the heart is resting.

Is my blood pressure normal?

See the following blood pressure classifi cation chart re-

leased by the WHO (World Health Organization) for evalu­ation of your blood pressure level.

Diastolic mm Hg

Severe hypertension (Grade 3)

Moderate Hypertension (Grade 2)

Mild Hypertension (Grade 1)

High - normal

Normal

Optimal

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Systolic mm Hg

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Information you should know
before operating the unit

What about low blood pressure?

In general, a lower blood pressure reading is better unless

it causes some uncomfortable symptoms such as fainting
and/or lightheadedness.

Fluctuation and variation in blood pressure

The following chart shows possible blood pressure fl uctua-
tions during a 24hr period.

mmHg

The following factors will infl uence blood pressure meas-
urement results and cause variations.

• Bathing • Breathing

• Conversation • Drinking alcohol

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• Exercise • Moving

• Mental tension • Meals

• Temperature change • Thoughts

• Smoking etc.

About the unit

Explanation of Display

Memory

Systolic

Date/
Time

Systolic

Diastolic

Diastolic

Arrhythmia

Detection

Pulse

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Low Battery

About the Unit

Cuff

LCD Display

Memory Button

The cuff is designed to fi t arm sizes

between 22 and 32cm (8.7 to 12.6 inches.)

Preparation for Use

access for power supply

On/Off
Button

Installing/Replacing Batteries

1. Insert the batteries into

the battery compartment
matching correct polarities

„+“ and „-“.

2. Replace all batteries if the

low battery indicator ap­pears.

3. Remove the batteries if

the unit will not be usedfor
a long period of time.

4. REMOVE all of the BAT-

TERIES when utilizing the

optional AC adapter.

Note: It is recommended that the same type of alka­line batteries be used to avoid incompatibility.

Keep batteries away from small children. Do not throw
batteries into fi res: they could explode.

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Preparation for Use

Attaching the Pressure Cuff

1. Wrap the cuff around the left

arm. The arm should be bare
skin.

2. Fasten the cuff. Don‘t pull it

strongly and make the cuff too
tight. The cuff‘s edge should
be approximately 1 inch from
crook of the arm.

3. Attach the cuff on the right

hand as shown in the fi gure if it
is not possible to measure on
the left arm.

Measuring Posture

1. Sit upright and ensure that the

measuring site is at heart level.
Relax and measure in a natural
position.

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2. Measure and record blood pressure at the same time

every day to establish your blood pressure pattern.

AC Adapter (accessory)
Use the device only with a medical approved stabi­lized AC adapter (Input: 100~240 V, AC, 60/50Hz;
Output: 6V, DC, 800mA).

Note:

1. No batteries are required during operation using
the AC adapter.

2. If AC adapter power is interrupted during meas­urement, the device must be reset by discon­necting the AC adapter from the device.

3. Only use medical approved adapters that com­ply with the specifi cations in this manual. Using
other adapters could cause damage your blood
pressure monitor.

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How to Operate the Unit

1.Setting the Clock

To enter the setting mode by press­ing and holding the memory key for
over 3 seconds.
The display will show a blinking
year.
Press the power key to adjust the
year when it is blinking.
Then press and release the memory
key again, the “month” will appear
and blink to be adjusted, and then
“date”, “hour” and “minute” will fol­low up as you press and release the
memory key again.

To adjust the clock

Press the memory key to adjust the values of the ”month”,

“date”, “hour”, and “minute” when they are blinking.

2. Measuring Blood Pressure

Press and release the POWER key to start
measuring automatically

Î Initial display

Î Pumping

Î Measuring and

Buzzer sounds.

When the measurement is fi nished, the display will show
the measured blood pressure and pulse value. Press the
power key to turn off the unit. Otherwise the unit will turn off
automatically 150 seconds later.

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How to Operate the Unit

Note: If the symbol appears, it means the

unit has detected irregular pulse during measurement. If
the symbol appears regularly please consult a qualifi ed
physician for professional advice.

3. Recalling Memories

Press and release the MEMORY key to recall the last read-

ing (Example: the no.7 memory). The display will show the

memorized pressure and pulse value.

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Press and release
the MEMORY key
again to recall the
no.6 memory.
Press and release
repeatedly to read
the no 5, 4, 3, 2, 1
memorized
pressures.

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How to Operate the Unit

4. Erasing Memories

You may erase one or all records in memory.

Delete one record

1. Press and release MEMORY key to choose the record
that you wish to delete

2. Press and hold the POWER key until the display shows

“dEL”.

3. Press and release the power key again.

After 3 beeps are heard, the unit erases the record.

Delete all records

1. Press and release MEMORY key to choose the record
that you wish to delete.

2. Press and hold the POWER key until the display shows

“dEL”.

3. Press and release the MEMORY key then the display
shows “dEL ALL”.

4. Press and release the POWER key. After 3 beeps are
heard, the unit erases all records.

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Care and Maintenance

Do not drop the unit.
It is not shock-proof.

Do not modify or
disassemble the unit
or the arm cuff.

Do not twist the arm cuff.

Use a cloth mois­tened with water or
neutral detergent to
clean the body of the unit
and then wipe it dry.

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Care and Maintenance

Avoid thinner, benzine,
and other harsh
cleaners.

Keep the unit in a
suitable place.
Avoid high tempera­ture, direct sunlight,
high moisture, and dust.

Remove the batteries
if the unit will not be
used for a long time.

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Do not press the
POWER button if the
cuff has not been
properly wrapped
around the arm.

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Error Messages

The pressure measured was
lower than 20 mm Hg.

Please measure again.

Excessive body movement is
detected during measurement.

Please measure again.

Pumping error.

Please check cuff and try
again.

The pressure can not be
measured due to signal noise.

Please measure again.

The pumping pressure is
higher than 300 mm Hg.

Please measure again.

Low battery.

Check and replace the 4

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batteries if necessary.

Disposal

Observe the applicable regulations when disposing of the
device and batteries.
This product must not be disposed of together with domes­tic waste.
All users are obliged to hand in all electrical or electronic
devices, regardless of whether or not they contain toxic
substances, at a municipal or commercial collection point
so that they can be disposed of in an environmentally ac­ceptable manner.

Please remove the batteries before disposing of the de-

vice/unit.

Do not dispose of old batteries with your house­hold waste, but at a battery collection station at a

recycling site or in a shop.

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Specifi cations

Model no. GP-6621

Display System Liquid Crystal Display

Measuring Method Oscillometric

Power Source 4 alkaline “AA“ type batteries
(1.5 V) or AC adapter (input:
100~240 V, AC, 60/50 Hz;
output: 6 V, DC, 800 mA)

Measuring Range Blood pressure:
20 to 300 mmHg
Heart pulse rate:
40 to 200 pulse beats/min

Accuracy Blood pressure:
Heart pulse rate: ±3 mm Hg

Pressure Exhaust Electric solenoid valve

Memory 85 sets
Display LCD (year/date/time,

Low Battery Indicator Yes
Auto Power-Off 150 secs. without any

operation

Battery Life Around 250 measurements
Protection Level IP20 (protected against

Cuff Size 22 to 32 cm / 8.7 - 12.6 inches
Operating Environment +5 °C to +40 °C;

RH 15 % to 90 %
(+41 °F to +104 °F)

Storage Environment -25 °C to +55 °C;
RH 15 % to 90 %
(-4 °F to +122 °F)

Dimensions 171 mm x 139 mm x 54 mm
Weight around 550 g

(including batteries)

pulse rate: ±5 % Infl ation
Micro rolling pump

pressure and pulse)

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foreign bodies < 12,5 mm)

Specifi cations are subject to change for

improvement without notice.

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Quality Standard

Geratherm® is certifi ed in accordance with Council Direc-
tive 93/42/EEC and EN ISO 13485 and is entitled to affi x
the CE-mark 0197 (Notifi ed Body: TÜV Rheinland LGA
Products GmbH).

The blood pressure monitor conforms to

• EN 1060-1 (Non-invasive sphygmomanometers part 1:

General requirements)

• EN 1060-3 (Non-invasive sphygmomanometers part

3: Supplementary requirements for electromechanical
blood pressure measuring systems)

• EN 1060-4 Non-invasive sphygmomanometers, Part 4:

Test procedures to determine the overall system accu-

racy of automated non-invasive sphygmomanometers

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Symbol index

15%

-25°C

90%

+55°C

Follow the instruc­tions for use

Keep dry

Store between 15 %
and 90 % R.H.

Store between

-25 °C and +55 °C

The device must not
be disposed of with
household waste.

SN

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Type BF Equipment

Batch code
(mm/yyyy; month/year)

Serial number

Manufacturer

Important! Read the
instruction manual!

Annex

Information on electromagnetic compatibility
(EMC)

Electronic devices such as PCs and mobile phones can

lead to the exposure of medical devices in operation to
electromagnetic interference from other devices. This can

lead to malfunction of the medical device and create a po­tentially unsafe situation.

Medical devices should also not interfere with any other
devices.

The EN 60601-1-2 standard regulates the requirements for
EMC (electromagnetic compatibility) and defi nes the levels
of immunity to electromagnetic interference and the maxi­mum electromagnetic emission levels for medical devices.

This blood pressure monitor, which is manufactured by
Geratherm Medical AG, complies with the EN 60601-1-2
standard in relation to both immunity and emissions.
However, special precautions should be observed:
please only use the device indoors and not in the vicinity
of mobile phones or microwave ovens. In the case of de­vices whose maximum power exceeds 2 W, the minimum
distance from your blood pressure monitor should be 3.3
metres.

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Annex

Guidance and manufacturer´s declaration – electromagnetic emissions

The device is intended for use in the electromagnetic environments listed below, and
should only beused in such environments:

Emissions test Compliance Electromagnetic environment - guidance

RF emissions CISPR 11 Group 1

RF emissions CISPR 11 Class B

Harmonic emissions
IEC 61000-3-2

Voltage fl uctuations / fl icker
emissions IEC 61000-3-3

Guidance and manufacturer´s declaration – electromagnetic emissions

The device is intended for use in the electromagnetic environments listed below, and
should only beused in such environments:

Immunity test

Electrostatic
discharge (ESD)
IEC 61000-4-2

Power frequency
(50/60 Hz)
magnetic fi eld
IEC 61000-4-8

IEC 60601 –
test level

± 6 kV contact
± 8 kV air

3 A/m 3 A/m

RF energy is used only to maintain device’s
operation. Therefore, its RF emissions are so
low that it’s not likely to cause any interfer­ence in nearby electronic equipment.

The device is suitable for use in all establish­ments, including domesticestablishments,

Class A

and those directly connected to the public
low-voltage power supply networkthat sup­plies buildings used for domestic purposes.

complies

Compliance

Electromagnetic environment -

level

guidance

Floors should be wood, concrete

± 6 kV contact

or ceramic tile. If fl oors are covered

± 8 kV air

with synthetic material, the relative
humidity should be at least 30 %.

Power frequency magnetic fi elds
should be at levels characteristic of
a typical location in a typicalcommer­cial or hospital environment.

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Recommended separation distances between portable and mobile RF communication

The device is intended for use in an electromagnetic environment where radiated RF
disturbancesare under control. User can help prevent electromagnetic interference by
keeping the device at a minimum distance from portable and mobile RF communications
equipment (transmitters). Below table details the maximum output power of transmitter:

Rated maximum
output power
of transmitters
in Watt

0.01

0.1
1
10
100

For transmitters rated at a maximum output power not listed above, the recommended
separation distance d in metres (m) can be estimated using the equation applicable to the
frequency of the transmitter, where P is the maximum output power rating of the transmit­ter in watts (W) according to the transmitter manufacturer.

NOTE 1:

NOTE 2: These guidelines may not apply in all situations. Electromagnetic

Seperation distance according to frequency of transmitter / m

150 kHz to 80 MHz
d = 1.2 √P

0.12

0.38

1.2

3.8
12

At 80 MHz and 800 MHz, the separation distance for the higher fre­quency range applies.

propagation is affected by absorption and refl ection from structures,
objects and people.

80 MHz to 800 MHz
d = 1.2 √P

0.12

0.38

1.2

3.8
12

800 MHz to 2.5 GHz
d = 2.3 √P

0.23

0.73

2.3

7.3
23

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Annex

Guidance and manufacturer´s declaration – electromagnetic immunity

The device is intended for use in the electromagnetic environments listed below, and
should only be used in such environments:

IEC 60601

Immunity test

Conducted
RF IEC
61000-4-6

Radiated
RF IEC
61000-4-3

NOTE 1: At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2: These guidelines may not apply in all situations. Electromagnetic

Guidance and manufacturer´s declaration – electromagnetic immunity
a) Field strengths from fi xed transmitters, such as base stations for radio (cellular/cord-

less) telephones and land mobile radios, amateur radio, AM and FM radio broadcast
and TV broadcast cannot be predicted theoretically with accuracy. To assess the
electromagnetic environment due to fi xed RF transmitters, an electromagnetic site
survey should be considered. If the measured fi eld strength in the location in which
the device is used exceeds the applicable RF compliance level above, the device
should be observed to verify normal operation. If abnormal performance is observed,
additional measures may be necessary, such as reorienting or relocating the device.

b) Over the frequency range 150 kHz to 80 MHz, fi eld strengths should be less than

3 V/m.

Compliance

– test
level

3 Vrms
150 kHz to
80 MHz

3 V/m
80 MHz to

2.5 GHz

propagation is affected by absorption and refl ection from structures,
objects and people.

Electromagnetic environment - guidance

level

Portable and mobile RF communications
equipment should be used no closer to any
part of the device, including cables, than the
recommended separation distance calculated
from the equation applicable to the frequency
of the transmitter.

Recommended separation distance:

3 Vrms d = 1.2 √P

d = 1.2 √P

3 V/m

80 MHz to 800 MHz

d = 2.3 √P
800 MHz to 2.5 GHz

where P is the maximum output power rating
of the transmitter in watts (W) according to the
transmitter manufacturer and d is the recom­mended separation distance in metres (m).

Field strengths from fi xed RF transmitters, as
determined by an electromagnetic site survey,
should be less than the compliance level in
each frequency range.b

Interference may occur in the
vicinity ofequipment marked
with the following symbol:

a

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Geratherm Medical AG
Fahrenheitstrasse 1
98716 Geschwenda
Germany
www.geratherm.com

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