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EN
INSTRUCTIONS FOR USE
GT-1215
Digital wrist Blood pressure monitor
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EN
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 wrist. All values can be read
on an LCD screen. This unit has been developed for home use and should only be used by adults over
18 years of age with a wrist diameter between 13.5 and 21.5 cm.
Designated Use ..............................................................................................................................
Precautions ....................................................................................................................................
Warranty .........................................................................................................................................
Information You Should Know Before Operating the Unit .........................................................
Measurement Principle .................................................................................................................
About the Unit ................................................................................................................................
Information about the Device .....................................................................................................
Explanation of Display ...............................................................................................................
Preparation for Use .......................................................................................................................
Power Supply and Charging Power ...........................................................................................
Activate your Blood Pressure Monitor .......................................................................................
Setting Date and Time ...............................................................................................................
Attaching the Cuff ......................................................................................................................
Measuring Posture ....................................................................................................................
How to Operate the Unit ................................................................................................................
Measuring Blood Pressure ........................................................................................................
Retrieving Readings ..................................................................................................................
Deleting Readings .....................................................................................................................
Care and Maintenance ..................................................................................................................
Error Messages ..............................................................................................................................
Specifi cations ................................................................................................................................
Quality Standard ............................................................................................................................
Symbol Index .................................................................................................................................
Annex ..............................................................................................................................................
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Contents
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Precautions
• This manual and the product are not substitutes for visiting the doctor. 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 doctor.
• If the cuff pressure exceeds 300 mmHg (40 kPa), the air in the cuff is automatically released. If the
cuff does not empty when the pressure exceeds 300 mmHg (40 kPa), remove the cuff from your
wrist and press the „START“ button to stop the infl ation process.
• Before using the unit for the fi rst time, ensure that there is no visible damage to the unit.
• 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.
• This unit is not suitable for continuous monitoring during medical emergencies or surgery. This unit
cannot be used simultaneously with high-frequency surgical devices.
• Please operate the unit under the environmental conditions described in the instructions. Otherwise,
the performance and service life the blood pressure monitor will be adversely affected.
• The material of the cuff has been tested and meet 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.
• Dispose of the unit and accessories in accordance with local regulations .
• Consult your doctor before using the unit if you are pregnant, have implanted electrical devices, are
suffering from pre-eclampsia, atrial fi brillation or peripheral arterial disease, or if you have under-
gone intravascular therapy or a mastectomy.
• Keep the unit out of the reach of toddlers, children and pets. The inhalation or swallowing of small
parts is dangerous and could be fatal.
• Too frequent and successive measurements may lead to disturbances of the blood circulation and
cause injury.
• Do not use the cuff on damaged skin.
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Precautions
• 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.
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 pres-
sure is the result of these two forces.
What are systolic and diastolic blood pressures?
Systolic blood pressure is the highest pressure at the heart‘s maximum contraction. Diastolic blood
pressure is the lowest pressure when the heart is resting
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
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Information You Should Know Before Operating the Unit
Is my blood pressure normal?
See the following blood pressure classifi cation chart released 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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Information You Should Know Before Operating the Unit
What does low blood pressure mean?
In general, a lower blood pressure reading is better unless it causes unpleasant symptoms such as
fainting and/or lightheadedness.
Fluctuation and variation in blood pressure
The following chart shows possible blood pressure fl uctuations during a 24-hour period.
mmHg
Systolic
Diastolic
The following factors will infl uence blood pressure measurement results and cause variations:
• Bathing • Conversation
• Drinking alcohol • Exercise
• Moving • Stress
• Meals • Temperature change
• Thoughts • Smoking etc.
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Measurement Principle
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. As it does so, the unit detects pressure oscillations generated by the
pulsation of the blood fl ow.
The device compares the longest and the shortest time intervals of detected pulse waves with the mean
time interval and then calculates the standard deviation.
Along with the blood pressure reading, the device also shows a symbol (arrhythmia icon) if the heart
beat is irregular. (> 25 %)
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About the Unit
Information about the Device
LCD Display
Cuff
Diastolic
Pulse rate
Systolic
“MEM” button
Time
WHO - grade
Content:
1. Blood pressure monitor wrist type (GT-1215)
2. User manual
3. USB cable ( 5 V = 1 A)
4. Storage bag
USB power
interface
“START” button
The cuff is suitable for wrist circumferences between 13.5 and 21.5 cm.
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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 lead to inaccurate
readings
Arrhythmia Irregular heartbeat Detection
Position
control
Taking up the correct position is neces-
sary for obtaining accurate readings.
The average
value
The average value of the latest 3
blood pressure measurement results
Low battery
Battery is low and needs to be
charged
WHO Grade
Classifi cation of the reading accord-
ing to the WHO
Current date
and time
Month/day, hour/minute
Memory
The displayed measurement values is
from the memory.
Heartbeat
Heartbeat detection during the
measurement
Explanation of the Display
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Preparation for Use
Power Supply and Charge Power
1. The battery of the Geratherm active control is a built-in lithium-ion battery with an electrical charge
of 420 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 illustrations:
Method 1
Method 2
Power needs to be charges under the following circumstances:
on the LCD display
Note: Optional Adapter
(Please use an authorised adapter)
Input: AC 100 - 240 V ~ 50/60 Hz 0,4 A Max
Output: 5 V 1000 mA
AC - adaptor
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Preparation for Use
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 in good time. You can still carry out the measurement.
If the LCD displays “
“means the battery is too low, the blood pressure monitor will turn off
automatically, you must charge the power at once.
During the process of charging, the LCD display will display the blinking power level, just like the following pictures:
When there is no power, the LCD will
displays as the following when it is
charging:
When there is one level of power, the
LCD will displays as the following when
it is charging:
When there are two levels of power, the
LCD will displays as the following when
it is charging:
When there are three levels of power, it
means the power is full, the LCD
will displays as the following when it is
charging:
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Preparation for Use
CAUTION:
• battery of Geratherm active control is built-in rechargeable lithium-ion battery, please do not
attempt to disassemble the blood pressure monitor or force open the built-in battery by the
unauthorized maintenance personnel.
• 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 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.
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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.
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Preparation for Use
4. Repeat steps 2 and 3 to set the [MONTH] and [DAY].
5. Repeat steps 2 and 3 to set the [HOUR] and [MINUTE].
6. Repeat steps 2 and 3 to switch position control on or off. After
confi rming this as described in step 3, all the settings will be
successively shown on the display. Then the unit will turn off.
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Preparation for Use
Attaching the cuff
1. Wrap the cuff around the bare wrist. The display should
face the side of the palm of the hand.
2. Fasten the cuff. Make sure it is not too tight. The cuff‘s upper edge should be approximately 1 cm (0.39 inch) from the
palm line.
Measuring posture
1. Sit upright and position your lower arm in such
a way that the unit 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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How to Operate the Unit
Measuring Blood Pressure
1. When the monitor is off, press the “START” button to turn on the monitor, and it will fi nish the whole
measurement.
2. As soon as the measurement is completed, the blood pressure and pulse readings appear on the
display. Press the “START” button to switch off the unit. Otherwise, the unit will switch off automatically after one minute.
LCD display 0 – value is shown
Infl ating and
measuring
Results are displayed and stored
in the memory
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How to Operate the Unit
Note:
If you have turned on the Position Control function, once the measurement
starts, the blood pressure monitor will detect the gestrure fi rst. The wrist
must be between the angle of 30° and 45°. If the position is out of this
angle, the measurement will not start and the display will show Symbol
+ ERR until you have the correct position.
Note:
If you have the correct position, the display will show for about
3 seconds, and then continue with the measurement.
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How to Operate the Unit
Retrieving Readings
1. When the monitor is off, please press
“MEM” button to show the average value
of the latest three records.
(Note: If the records are less than 3
groups, the LCD will display the recent
record instead.)
Note:
The device can record 60 measurements.
2. By pressing again on the “MEM” button, all stored readings can be retrieved. The number of the
stored reading is shown in the bottom left-hand corner. This appears alternately with the time when
the reading was taken. The date is shown underneath.
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.
stored value
No. 1
Month and day
Time
Month and day
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How to Operate the Unit
Deleting Readings
1. Hold pressing “MEM” button for 3 seconds when the monitor is in memory
mode, the display will show “dEL ALL” (“delete all”) .
2. Press “MEM” button to confi rm deleting and the monitor will display “dEL dOnE”
(”deletion done”) and then turn off.
3. If there is no record press “MEM” button, the LCD will display “0”.
Note:
To exit out of delete mode without deleting any records, press “START” button before pressing “MEM“
button to confi rm any delete commands.
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Care and Maintenance
Do not drop the unit.
Do not modify or disassemble the
unit or the 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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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
until the cuff has been properly
fastened on the wrist.
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Error messages
Problem Display symbol Cause Solution
No power
Display is dim or
will not light up
The power is
exhausted
Charge the power
Low
battery
The power is low Charge battery
No display
There is no
display when you
press any buttons
Unit is not activated.
Press and hold “MEM” button to log
out of the shipping mode
Error
massage
E 3
The cuff is not properly
fastened or pressure in
the cuff is too high.
Rest for a short time, then re-fasten
the cuff and measure your blood
pressure again.
E10 or E11
The unit has detected
movement or pulse rate
is too low.
Relax for a moment and then
measure again
E20
The measurement process does not detect the
pulse signal
Loosen the clothing on the arm and
then measure again
E21
The measuring process was not successful.
Relax for a moment and
then measure again
EExx
A calibration error
occurred
Retake the measurement. If the
problem persists, contact the
retailer or our customer service
department for further assistance.
Refer to the warranty for contact
information and return instructions.
Out of range
measurement
Relax for a moment. Refasten the
cuff and then measure again. If
the problem persists, contact your
physician.
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Specifi cations
Subject to changes in the interests of technical progress.
Model no. GT-1215
Power supply 3.7 V 420 mAH Built-in rechargeable lithium-ion battery
Display mode Digital LCD Display V.A. 44.8 mm x 35.6 mm
Measurement mode Oscillographic testing mode
Measurement range
Rated cuff pressure: 0mm Hg ~ 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 - 106 kPa
Storage & transportation condition
Temperature: -20 °C to 60 °C
Relative humidity: 10 % RH to 93 % RH
Cuff size 13.5 cm ~ 21.5 cm
Weight 106 g (including the cuff)
External dimensions approx. 84 mm x 70 mm x 40 mm
Attachment USB cable, storage bag, user manual
Degree of protection IP22
Device classifi cation Battery mode: with built-in lithium-ion rechargeable battery
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Quality Standard
Risk
management
ISO/EN 14971 Medical devices - Application of risk management to medical
devices
Labeling EN 980 Symbols for use in the labelling of medical devices
User manual EN 1041 Medical equipment manufacturers 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: Requirements
and test methods for non-automated measurement type (ISO 81060-1)
EN 1060-3+A2 Non-invasive blood pressure Part 3: Supplementary requirements for electromechanical blood pressure measuring system
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
Geratherm
®
is certifi ed in accordance with Council Directive 93/42/EEC and EN ISO 13485 and is enti-
tled to affi x the CE-mark (Notifi ed Body: TÜV Rheinland LGA Products GmbH).
The blood pressure monitor conforms to:
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Symbol Index
Follow the instructions for use Type BF Equipment
Keep dry
Manufacturer
93 %
10 %
Store at relative humidity levels
between 10 % and 93 % RH
Batch code
(YYMMXXX, Year/Month /
Identifi cation number)
-20 °C
+60 °C
Store between
-20 °C and +60 °C
Caution! Read the instruction
manual.
The device must not be disposed of with household waste
Manufacturing date
Direct current
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EN
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 emis-
sion 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.
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 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
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EN
Annex
Guidance and manufacturer´s declaration – electromagnetic emissions
The device or system is intended for use in the electromagnetic environments listed below. The customer and/or user of
the device or system must ensure that it is used in an electromagnetic environment as described below:
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
Power frequency magnetic fi elds should be at levels
characteristic of a typical location in a typicalcommercial
or hospital environment.
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
Separation distance / m
0.01
0.1
1
10
100
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
0.12
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 separation distance for the higher frequency range applies.
NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected
by absorption and refl ection from structures, objects and people.
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EN
Annex
Guidance and manufacturer´s declaration – electromagnetic immunity
The device or system is intended for use in the electromagnetic environments listed below. The customer and/or user of
the device or system must ensure that it is used in an electromagnetic environment as described below:
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 610004-3
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 electro-
magnetic 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 propagation is affected by absorption
and refl ection from structures, objects and people.
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EN
Annex
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.
Page 30
Geratherm Medical AG
Fahrenheitstraße 1
98716 Geschwenda
Germany
www.geratherm.com
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