Page 1
EN
Digital Blood Pressure Monitor
for the Upper Arm
INSTRUCTIONS FOR USE
GT-1115
Page 2
34
EN
Designated Use ....................................................... 35
Measurement Principle ........................................... 35
Precautions .............................................................. 36
Warranty ................................................................... 38
Information You Should Know
Before Operating the Unit ...................................... 39
Irregular Heartbeat Detector .................................. 41
About the Unit
Monitor Components ........................................... 42
Explanation of Display ......................................... 43
Preparation for Use
Power Supply and Charge Power ......................... 44
Activate your blood pressure monitor .................... 44
Setting Date and Time .......................................... 47
Selecting a User ................................................... 48
Attaching the Pressure Cuff .................................. 49
Measuring Posture ................................................ 49
How to Operate the Unit
Measuring Blood Pressure ................................... 50
Recall the Records ............................................... 51
Delete the Records ............................................... 52
Care and Maintenance ............................................ 53
Error Messages ....................................................... 55
Specifi cations .......................................................... 56
Quality Standard ..................................................... 58
Symbol Index ........................................................... 59
Annex ....................................................................... 60
Contents
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EN
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 with an arm diameter of 22 ~ 42 cm / 8.7 - 16.5 inches.
Designated Use
This product uses the Oscillometric Measuring method
to detect blood pressure. Before every measurement,
the unit establishes a “zero pressure” equivalent to the
air pressure. Then it starts infl ating the cuff, meanwhile,
the unit detects pressure oscillations generated by beatto-beat pulsatile, which is used to determine the systolic
and diastolic pressure, and also pulse rate.
The device compares the longest and the shortest time intervals of detected pulse waves to mean time interval then
calculates standard deviation. Along with the blood pressure reading, the device also shows a symbol (arrhythmia
icon) if the heart beat is irregular. (> 25 %)
Measurement Principle
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EN
• This manual and the product are not substitutes for
consulting a physician. Neither the information contained herein nor this product 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 physician.
• Please ask your physician before using the device
on pregnant women, patients with implanted, electrical devices, patients with pre-eclampsia, premature
ventricular beats, atrial fi brillation, peripheral, arterial
disease and patients undergoing intravascular therapy
or arterio-venous shunt or people who received a mastectomy. Please consult your physician prior to using
the unit if you suffer from any of these illnesses.
• 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 meas-
urement.
• Do not take any therapeutic measures on the basis of
a self-measurement. Never alter the dose of a medicine prescribed by a physician. Consult your physician
if you have any questions about your blood pressure.
• Please keep the unit out of reach of infants, children
or pets, since inhalation or swallowing of small parts is
dangerous or even fatal.
• This device is intended for non-invasive measuring
and monitoring of arterial blood pressure. It is not
intended for use on extremities other than arm or for
functions other than obtaining a blood pressure meas-
urement.
• If you experience discomfort during a measurement,
such as pain in the arm or other complaints, press the
“START” button to release the air immediately from the
cuff. Loosen the cuff and remove it from your arm.
• On the rare occasion of a fault causing the cuff to re-
main fully infl ated during measurement, open the cuff
immediately. Prolonged high pressure (cuff pressure
• >300 mmHg or constant pressure >15 mmHg for more
than 3 minutes) applied to the arm may lead to an ecchymosis.
• Too frequent and consecutive measurements could
cause disturbances in blood circulation and injuries.
Precautions
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EN
Precautions
• Do not wrap the cuff around an arm to which medical
devices are attached, as this could lead to temporary
functional failure of the medical devices being used.
• Avoid any kinks in the air hose during use, as this
could lead to a continuous increase in the cuff pressure and cause injury to the patient.
• This unit is not suitable for continuous monitoring dur-
ing medical emergencies or surgery. This unit cannot
be used simultaneously with high-frequency surgical
devices.
• This unit is not intended for the transportation of pa-
tients outside medical establishments.
• In order to avoid inaccurate measurements, do not
expose the blood pressure monitor to strong electromagnetic fi elds.
• The material of the cuff has been tested and meets the
requirements for the biological evaluation of medical
devices in accordance with the standards DIN EN ISO
10993-5 and DIN EN ISO 10993-10. The constituent
materials do not have the potential to produce any irritation or allergic reactions.
• Do not use the cuff on damaged skin.
• Do not use the device in the case of known allergies to
polyester or synthetic materials.
• In order to avoid accidental strangulation, keep the de-
vice away from children and do not lay the tube around
the neck.
• Do not connect the air hose to any other medical de-
vices, as this can lead to high pressure or conduct air
into intravascular systems, which may lead to injury.
• Before using the unit for the fi rst time, ensure that there
is no visible damage to the unit.
• Please operate the unit under the environmental condi-
tions described in the instructions. Otherwise, the per-
formance and service life of the blood pressure monitor
will be adversely affected.
• Please use only accessories that have been approved
by the manufacturer. Otherwise, damage may be
caused to the unit, the user may suffer injury or inaccurate measurements may occur.
• Dispose of the unit, accessories and components in
accordance with local regulations.
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EN
Precautions
Warranty
The warranty for this blood pressure monitor is valid for
any error on the part of the manufacturer under normal
use for 2 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.
• In the event of malfunction, do not attempt to repair the
unit yourself. Only permit repairs to be carried out by
authorised technicians.
• In the event of unexpected error messages, please
contact your dealer.
• For cleaning, please use a soft cloth and a solvent-free
cleaning agent.
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EN
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 vascular system. Another force is created by the arteries as
they resist the blood fl ow. Blood pressure is the result of
these two forces
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 mmHg
Systolic mmHg
130
180170160150140
120
80
85
90
95
100
105
110
Severe Hypertension (Grade 3)
Moderate Hypertension (Grade 2)
Mild Hypertension (Grade 1)
Optimal
Normal
High - Normal
borderline
Classifi cation of
blood pressure
monitor
Systolic
mmHg
Diastolic
mmHg
Colour
indicator
Optimal < 120 < 80 green
Normal 120 - 129 80 - 84 green
High - Normal 130 - 139 85 - 89 green
Grade 1
Hypertension
140 - 159 90 - 99 yellow
Grade 2
Hypertension
160 - 179 100 - 109 orange
Grade 3
Hypertension
>= 180 >= 110 red
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EN
Information you should know before
operating the unit
What are systolic and diastolic pressures?
Systolic pressure is the highest pressure at the height of
the heart’s contraction. Diastolic pressure is the lowest
pressure when the heart is resting.
What about low blood pressure?
In general, a lower blood pressure reading is better un-
less it causes unpleasant symptoms such as fainting and/
or lightheadedness.
Fluctuation and variation in blood pressure
The following chart shows possible blood pressure fl uctu-
ations during a 24-hour period.
The following factors will infl uence blood pressure mea-
surement results and cause variations:
• Bathing • Conversation
• Drinking alcohol • Exercise
• Moving • Stress
• Meals • Temperature change
• Thoughts • Smoking etc.
mmHg
Systolic
Diastolic
PM AM
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EN
Irregular heartbeat detector
An irregular heartbeat is detected when a heartbeat
rhythm varies while the unit is measuring the systolic and
diastolic blood pressure. During each measurement, this
equipment records the heartbeat intervals and works out
the standard deviation. If major pulse irregularities occur,
the arrhythmia icon appears on the display along with the
blood pressure readings.
CAUTION
The appearance of the arrhythmia icon indicates that a
pulse irregularity consistent with an irregular heart-beat
was detected during measurement. Usually this is NOT a
cause for concern. However, if the symbol appears often,
we recommend you seek medical advice. Please note
that the device does not replace a cardiac examination,
but serves to detect pulse irregularities at an early stage.
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EN
About the unit
The cuff is designed to fi t arm sizes between
22 and 42 cm (8.7 to 16.5 inches).
MEM button
START button
LCD Display
USB Ppower interface
Cuff
Air Hose
Air connector plug
Air connector plug
Content:
1. Blood pressure monitor (GT-1115)
2. Cuff (Type BF applied part) 22 cm - 42 cm
3. User manual
4. USB cable (5 V = 1 A)
5. Storage bag
Information about the Device
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EN
About the unit
Symbol Description Explanation
Systolic blood
pressure
High pressure result
Diastolic blood
pressure
Low pressure result
Pulse Pulse/Minute; Beats/Minute
Movement
detector
Movement will result in inaccurate.
Memory
The displayed measurement values
is from the memory.
Average value
The average value of the latest 3
blood pressure measurement results
Low battery
Battery is low and need to be
charged
Arrhythmia Irregular heartbeat detection
WHO classifi -
cation
WHO evaluation of the measured
values
Current date and
time
Month/Day, Hour/Minute
Heartbeat
Heartbeat detection during the
measurement
User 1
Start measurement and save the
measuring results for User 1
User 2
Start measurement and save the
measuring results for User 2
Explanation of the Display
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EN
Preparation for use
Power Supply and Charge Power
1. The battery of Geratherm active control+ is a built-in
rechargeable lithium-ion battery with an electrical
charge of 1000 mAh.
2. Please use a power adapter with a USB connection
(not included) or another source of power with a USB
connection and the enclosed USB cable for charging
the rechargeable battery, as shown in the following il-
lustrations:
AC - adaptor
Method 1
Method 2
Power needs to be charges under the following
circumstances:
displays on the LCD
Note: Optional Adapter
(Please use any authorized adapter)
Input: AC 100 - 240 V ~50/60 Hz 0,4 A Max
Output: 5 V
1000 mA
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EN
Preparation for use
Notes
If you switch on the blood pressure monitor and the LCD
display fl ashes “ “. This means that the battery charge
is low. Please recharge it.
You can, however, still carry out the measurement.
If the LCD display “
“ appears, this means that the
battery charge is too low. The blood pressure monitor will
switch off automatically and you must recharge it immediately.
During recharging, the LCD display fl ashes and shows
the following symbols:
If it is not charged at all, the
following symbols appear on the
LCD display during charging:
If charge level 1 has been
reached, the following symbols
appear on the LCD display during
charging:
If charge level 2 has been
reached, the following symbol appears on the LCD display during
charging:
If charge level 3 has been
reached, the following symbol appears on the LCD display during
charging:
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EN
Caution
• The battery of Geratherm active control+ is a built-in
rechargeable lithium-ion battery. Please do not try to
disassemble or force open the blood pressure monitor
yourself or permit unauthorised maintenance personnel to do so.
• In normal use, the battery can be recharged about 300
times. If the battery fails to recharge or the unit cannot
be used normally, please contact your dealer. If you
measure your blood pressure three times a day, the
unit can be used for up to 25 days without recharging.
• Do not use the blood pressure monitor during the
recharging process. When the unit is fully charged,
please pull out the plug in good time.
• Do not attempt to replace the battery of your blood
pressure monitor. The battery is built-in and is not replaceable.
• Avoid recharging your blood pressure monitor in extremely high or low ambient temperatures.
• Do not clean the blood pressure monitor during recharging. Always remove the charging unit before
cleaning.
Preparation for use
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EN
Preparation for use
Activate your blood pressure monitor
Your blood pressure monitor is activated when the date
and time are set.
Setting Date and Time
It is important to set the clock before using your blood
pressure monitor, so that a time stamp can be assigned
to each record that is stored in the memory. (time format:
24 H)
1. When the monitor is off, hold pressing
“MEM” button about 3 seconds to enter the
mode for year setting.
2. Press “START” button to change the year.
Each press will increase the numeral by
one in a cycling manner.
3. When you get the right year, press “MEM”
button to set down and turn to next step.
4. Repeat steps 2 and 3 to set
the [MONTH] and [DAY].
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EN
Preparation for use
5. Repeat steps 2 and 3 to set
the [HOUR] and [MINUTE].
6. After the [MINUTE] is set, the LCD will display all the
settings you have done and then turn off.
Select User
1. When the monitor is off, press and hold
“START” button to enter user setting mode.
The user ID will blink.
2. Then press “MEM” button to select the
user ID between User 1 and User 2.
3. After selecting the suitable user ID, press “START” button to confi rm. Then the LCD will turn off.
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Preparation for use
Attaching the Pressure Cuff
1. Wrap the cuff around the arm.
The arm should be bare skin.
2. Fasten the cuff in place. Do
not pull too hard on the cuff
and do not wrap
it too tightly. The
edge of the cuff
should be approximately 2.5 centimetres from the
crook of the arm.
3. Attach the cuff on the right arm if it is not possible to
measure on the left arm.
Posture during measurement
1. Sit upright and ensure that the cuff is at heart level. Relax and retain a natural posture during measurement.
2. Measure and record blood pressure at the same time
every day to establish your blood pressure pattern.
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EN
How to operate the unit
Measuring blood pressure
1. When the monitor is off, press the “START” button to
turn on the monitor, the measurement will be completed automatically.
2. As soon as measurement is completed, the blood
pressure and pulse readings appear on the display.
Press the “START” button to switch the unit off. Otherwise, the unit will switch off automatically after one
minute.
Both User 1 and User 2 have 60 memory slots.
LCD display 0 – value is
displayed
Infl ating and
measuring
Display and save
the measurement
results
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EN
How to operate the unit
Retrieving stored readings
1. In order to retrieve the latest readings, press the “MEM” button and
release it. The display will show
the average value (AVG) of the
last three readings. (Note: If fewer
than three readings are available,
the latest reading is shown)
2. By pressing again on the “MEM”
button, all stored readings can be
retrieved. The number and date of
the stored reading can be seen in
the bottom left-hand corner. The
stored reading appears alternate-
ly with the time when the reading
was taken.
The most recent record (1) is shown fi rst. Each new
measurement is assigned to the fi rst (1) record. All other
records are pushed back one digit (e.g., 2 becomes 3,
and so on), and the last record is dropped from the list.
3. In order to retrieve the readings of
another user, select that user in advance. See section on “Selecting a
user”.
To retrieve the stored readings,
press the “MEM” button and re-
lease it.
stored value
No. 1
month and day
time
month and day
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EN
How to operate the unit
4. Press “START” button to power off, otherwise it will
turn off within 1 minute.
Deleting readings
1. Press and hold the “MEM” button
for about 3 seconds when the unit
is already in memory mode.
The user and “dEL ALL” (delete
all) appears on the display.
2. Press the “MEM” button to confi rm
the deletion process. “dEL dOnE”
(deletion done) appears on the
display.
3. To check whether the deletion
process was successful, press
the“MEM” button. “0” should appear on the display.
Note:
To leave deletion mode without deleting readings, press
the “START” button.
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Care and maintenance
Do not drop the unit.
Do not modify or disassemble the unit or the
arm cuff.
Do not twist the 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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EN
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.
Do not press the “START”
button if the cuff has not
been properly wrapped
around the arm.
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EN
Error messages
Problem Display
symbol
Cause Solution
No power
Nothing
appears on
the display
Battery charge
too low
Charge battery
Low battery power
indicator
Battery charge
low
Charge battery
No display
No display
when
buttons
pressed
Unit is not
activated
Press and hold down
“MEM“ button to
activate the unit
Error
messages
E 3
The cuff is not
properly fastened
or pressure in the
cuff is too high
Rest for a short time,
re-fasten the cuff and
measure the blood
pressure again.
E10 or
E11
The unit has detected movement
or pulse rate is
too low.
Rest for a short time
and retake the measurement.
E20
No pulse signal is
detected
Loosen clothing
around the arm and
measure again.
E21
The measuring
process was not
successful.
Rest for a short time
and retake the measurement.
EExx
A calibration error
has occurred
Start the measuring
process again. If this
problem re-occurs,
contact your dealer.
Measured values
are outside the
measurement
range
Relax for a moment.
Re-fasten the cuff and
measure again. If the
problem re-occurs,
consult your physician.
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EN
Specifi cations
Model-No. GT-1115
Model-No.
3,7 V 1000 mAH built-in rechargeable
lithium-ion battery
Display mode
Digital LCD Display V.A.
44 mm x 64 mm
Measurement
mode
Oscillographic testing mode
Measurement
range
Rated cuff pressure:
0 mmHg ~ 300 mmHg
(0 kPa ~ 40 kPa)
Measurement pressure:
SYS: 60 mmHg ~ 230 mmHg
(8,0 kPa ~ 30,7 kPa)
DIA: 40 mmHg ~ 130 mmHg
(5,3 kPa ~ 17,3 kPa)
Pulse value: (40 - 199) beat/minute
Accuracy
Pressure: +/-3 mmHg (+/-0,4 kPa)
Pulse value: +/- 5 %
Normal working
condition
+5 °C to +40 °C
Relative humidity: ≤85 % RH
Air pressure: 80 kPa to 106 kPa
Storage and
transportation
condition
-20 °C bis +60 °C
Relative humidity: 10 % RH to
93 % RH
Cuff size 22 cm ~ 42 cm
Net Weight approx. 550 g excluding cuff
External dimensions
approx. 131 mm x 78 mm x 42 mm
Attachment USB cable, user manual, storage bag
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EN
Specifi cations
Degree of
protection
IP20
Device classifi -
cation
Battery mode: with built-in lithium-ion
rechargeable battery
Subject to changes in the interests
of technical progress
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EN
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
(Notifi ed Body: TÜV Rheinland LGA
Products GmbH).
The blood pressure monitor conforms to
Quality standard
Risk management
ISO/EN 14971
Medical devices — Application of risk
management to medical devices
Labelling
EN 980 symbols for the labelling of medical devices
Instructions
EN 1041
Medical equipment manufac-turers to
provide information
General Requirements for Safety
EN 60601-1 +A1
Medical electrical equipment - Part 1:
General requirements for basic safety and
essential performance
IEC/EN 60601-1-11
Medical electrical equipment - Part 1-11:
General requirements for basic safety and
essential performance
- Collateral standard: Requirements for
medical electrical equipment and medical
electrical systems used in the home
healthcare environment
Electromagnetic
compatibility
IEC/EN 60601-1-2
Medical electrical equipment – Part 1-2:
General requirements for basic safety and
essential performance
– Collateral standard: Electromagnetic
compatibility - Requirements and tests.
Performance
requirements
EN ISO 81060-1
Non-invasive sphygmomanometers – Part
1: Require- ments and test methods for
non-automated measurement type (ISO
81060-1)
EN 1060-3 +A2
Non-invasive blood pressure monitor - Part
3: Supplementary requirements for electromechanical blood pressure measuring
system
Page 27
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EN
Symbol index
Follow the instructions
for use
Type BF Equipment
Keep dry Manufacturer
93 %
10 %
Store at relative humidity levels between
10 % and 93 % R.H.
Batch code
(YYMMXXX; month/
year/identifi cation
number)
-20 °C
+60 °C
Store between
-20 °C und +60 °C
Caution! Read the user
manual
The device must not
be disposed of with
household waste
Manufacture date
Direct current
Clinical
investigation
DIN EN ISO 81060-2
Non-invasive sphygmomanometers – Part
2: Clinical investigation of automated
measurement type (ISO 81060-2)
Usability
IEC/EN 60601-1-6
Medical electrical equipment - Part 1-6:
General requirements
for basic safety and essential performance
- Collateral Standard: Usability
IEC/EN 62366
Medical devices - Application of usability
engineering to medical devices
Software life-cycle
processes
IEC/EN 62304 +AC
Medical device software - Software life
cycle processes
Quality standard
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EN
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.
Annex
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EN
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:
Emission test Compatibility Notes concerning the EM environment
RF emissions CISPR 11 Group 1
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.
RF emissions CISPR 11 Class B
The device is suitable for use in all establishments, including domesticestablishments,
and those directly connected to the public
low-voltage power supply networkthat supplies
buildings used for domestic purposes.
Harmonic emissions
IEC 61000-3-2
Class A
Voltage fl uctuations / fl icker
emissions IEC 61000-3-3
complies
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
IEC 60601 –
test level
Compliance
level
Electromagnetic environment guidance
Electrostatic
discharge (ESD)
IEC 61000-4-2
± 6 kV contact
± 8 kV air
± 6 kV contact
± 8 kV air
Floors should be wood, concrete or
ceramic tile. If fl oors are covered with
synthetic material, the relative humidity
should be at least 30 %.
Power frequency
(50/60 Hz)
magnetic fi eld
IEC 61000-4-8
3 A/m 3 A/m
The power frequency magnetic fi eld
should be measured at the intended
place of installation in order to ensure
that it is low enough.
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
Seperation distance according to frequency of transmitter / m
150 kHz to 80 MHz
d = 1.2 √P
80 MHz to 800 MHz
d = 1.2 √P
800 MHz to 2.5 GHz
d = 2.3 √P
0.01
0.1
1
10
100
0.12
0.38
1.2
3.8
12
0.12
0.38
1.2
3.8
12
0.23
0.73
2.3
7.3
23
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: At 80 MHz and 800 MHz the higher frequency range should be used.
NOTE 2: These guidelines may not be applicable in all situations. Electromagnetic
propagation is infl uenced by absorption and refl ection from buildings, ob-
jects and people.
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EN
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:
Immunity test
IEC 60601 –
test level
Compliance
level
Electromagnetic environment - guidance
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:
Conducted RF
IEC 61000-4-6
3 Vrms
150 kHz to
80 MHz
3 Vrms d= 1.2 √P
Radiated RF
IEC 61000-4-3
3 V/m
80 MHz to
2.5 GHz
3 V/m
d = 1.2 √P
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,
a
should be less than the compliance level in
each frequency range.
b
Interference may occur in the
vicinity ofequipment marked
with the following symbol:
NOTE 1: At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2: These guidelines may not apply in all situations. Electromagnetic propaga-
tion is affected by absorption and refl ection from structures, objects and
people.
Guidance and manufacturer´s declaration – electromagnetic immunity
a) Field strengths from fi xed transmitters, such as base stations for radio (cellular/cordless)
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.
1)
2)
This equipment needs to be installed and put into service in accordance with the information provided in the user manual;
Wireless communications equipment such as wireless home network devices, mobile
phones, cordless telephones and their base stations, walkie-talkies can affect this equipment and should be kept at least a distance d = 3,3 m away from the equipment.
(Note: As indicated in Table 6 of IEC 60601-1-2 for ME EQUIPMENT, a typical cell phone
with a maximum output power of 2 W yields d = 3,3 m at an IMMUNITY LEVEL of 3 V/m)
The current version of the standards is valid.
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EN
Geratherm Medical AG
Fahrenheitstraße 1
98716 Geschwenda
Germany
www.geratherm.com
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