Easy Med GT868UF - Blood pressure monitor Geratherm - Free user manual and instructions

Product type	Fully automatic upper arm blood pressure monitor
Brand	Geratherm
Model	Easy Med GT868UF
Measurement method	Oscillometric
Display	LCD (liquid crystal)
Blood pressure measurement range	0 to 300 mmHg
Pulse measurement range	40 to 199 beats/min
Blood pressure accuracy	±3 mmHg
Pulse accuracy	±5%
Memory	3 groups of 30 measurements each (90 total measurements)
Compatible arm circumference	23 to 33 cm
Power supply	4 AA alkaline batteries 1.5 V or AC adapter 6V DC 1A (optional)
Battery life	Approximately 300 measurements
Dimensions (W x D x H)	110 x 150 x 80 mm
Weight (with batteries)	Approximately 265 g
WHO classification	Color display (green, yellow, red) according to values
Arrhythmia detection	Yes (specific symbol)
Operating conditions	+5°C to +40°C, humidity 15% to 93% RH
Storage conditions	-25°C to +70°C, humidity ≤93% RH
Protection degree	IP22
Warranty	3 years (excluding batteries and cuff)
Cleaning	Cloth dampened with water or mild detergent, do not use solvents

Frequently Asked Questions - Easy Med GT868UF Geratherm

How to set the time and date on the Geratherm Easy Med GT868UF blood pressure monitor?

Press the SET button to select the memory group (1, 2 or 3). Then press MODE: the month flashes. Use SET to set, then MODE to go to day, hours and minutes. Confirm with MODE.

What type of batteries to use and how to replace them?

Use 4 AA alkaline batteries (1.5 V). Open the compartment, respect the + and - polarities. Remove batteries if not using for a long time. Replace all batteries as soon as the low battery symbol appears.

How to correctly place the cuff?

Place the cuff around the bare left upper arm, about 2.5 cm above the elbow crease. Do not over-tighten. The lower edge of the cuff should be at heart level.

What does the arrhythmia symbol mean?

If the irregular heartbeat symbol appears, the device detected an irregularity during measurement. If it appears frequently, consult a doctor.

How to clear the measurement memory?

Select the user (1, 2 or 3) with SET, then press MEMORY to enter memory mode. Press and hold MODE and SET simultaneously to clear all values of the group.

What to do in case of error messages E1, E2, E3 or EP?

E1: air circuit problem, check cuff connection. E2: pressure >300 mmHg, disconnect and restart. E3: measurement error, repeat. EP: contact retailer or Geratherm.

Can the device be used with an AC adapter?

Yes, use only a stabilized power supply approved for medical use (input 230V~50Hz, output 6V DC 1A). Remove batteries before connecting the adapter.

How to clean the blood pressure monitor?

Use a soft cloth dampened with water or mild detergent. Dry with a clean cloth. Do not use thinners, gasoline or abrasive products. Never immerse the device in water.

What is the warranty on the device?

The blood pressure monitor is warranted for 3 years against manufacturing defects from the date of purchase, excluding batteries and cuff. The warranty does not cover damage due to incorrect use.

How to interpret the results displayed with colors?

The color display follows WHO classification: green for optimal or normal blood pressure, yellow for normal to mild hypertension, red for hypertension (stage 1 to 3). Consult your doctor for precise interpretation.

USER MANUAL Easy Med GT868UF Geratherm

Fully automatic blood pressure monitor for the upper arm

Geratherm Medical AG

Fahrenheitstraße 1

98716 Geschwenda

Deutschland

C€0197

Fully Automatic Blood Pressure Monitor for the Upper Arm

Geratherm

easy med

EN

INSTRUCTION MANUAL

GT-868UF

C€0197

Contents

Designated use 26

Precautionary measures 27

Warranty 29

Information you should know before operating the unit 30

About the unit 31

Explanation of displays 32

Preparation for use

Installing/replacing batteries 32

Attaching the pressure cuff 33

Posture during measurement 34

Operations

Setting the time and date 35

Measuring blood pressure 35

Storing data

Recalling data 36

Erasing data 37

Disposal 37

Care and maintenance 38

Error messages 40

Specifications 41

Quality standard 42

Symbol index 43

Annex 44

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 use and should only be used by adults over 18 years of age with an arm diameter of 23 to 33cm /9 to 13 inches.

EN

• 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.

• Do not conduct any measurements if the temperature is low (below +5^ ) or high (over +40^ ), or if the relative humidity is beyond the range of 15% to 93% , 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.

• Wrap the cuff snug around your upper arm and lay your arm on a fl at surface at the same level as your heart.

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

• This unit is not suitable for use by people with cardiac arrhythmias or pregnant women.

• 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 specified DIN EN ISO 81060-2 standard limits.

• If the cuff causes any discomfort during the measurement, press the "START/STOP" button to turn off the unit immediately.

• If the pressure is over 300mmHg and the cuff does not deflate 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 disorders, 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 2W , 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.

EN

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 vascular system. Another force is created by the arteries as they resist the blood flow. Blood pressure is the result of these two forces.

Is my blood pressure normal?

See the following blood pressure classification chart released by the WHO (World Health Organization) for evaluation of your blood pressure level.

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 yellow
Grade 1 Hypertension	140 - 159 90	- 99 red
Grade 2 Hypertension	160 - 179 100	- 109 red
Grade 3 Hypertension	>= 180 >=	110 red

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 unpleasant symptoms such as fainting and/or lightheadedness.

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.

Fluctuation and variation in blood pressure

The following factors will influence blood pressure measurement results and cause variations.

Bathing, Breathing, Conversation, Drinking alcohol, Exercise, Moving, Mental tension, Eating, Temperature changes, Thoughts, Smoking etc.

About the unit

The cuff is designed to fit arm diameters between 23 and 33~cm / 9 to 13 inches.

Explanation of the display

EN

Preparation for use

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 used for a long period of time.
4. REMOVE all of the BATTERIES when utilising an 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 fire: they could explode.

Attaching the pressure cuff

1. Wrap the cuff around the left arm. The arm should be bare.
2. Fasten the cuff. Don't pull it too strongly or make the cuff too tight. The edge of the cuff should be approximately 1 inch from the crease of your elbow.

1. Attach the cuff on the right arm as shown in the figure if it is not possible to measure on the left arm.

EN

Posture during measurement

1. Sit upright and ensure that the measuring site is at heart level. Relax and retain a natural posture during measurement.

1. Measure and record blood pressure at the same time every day to establish your blood pressure pattern.

EN

AC adapter

Use the device only with a medical approved stabilized AC adapter (input: 230V AC, 50~Hz output: 6 V, DC, 1 A).

Note:

1. No batteries are required during operation using the AC adapter.
2. If AC adapter power is interrupted during measurement, the unit must be reset by disconnecting the AC adapter from the unit.
3. Only use medical approved adapters that comply with the specific cations in this manual. Using other adapters could cause damage your blood pressure monitor.

Setting the time and date

1. Press the "SET" button to select memory store 1, 2, or 3.
2. Press the "MODE" button ("month" starts flashing). Press the "SET" button to set the correct month.
3. Press the "MODE" button again ("date" starts flashing). Press the "SET" button to set the correct date.
4. Press the "MODE" button again ("hour" starts flashing). Press the "SET" button to set the correct hour in 12-hour format.
5. Press the "MODE" button again ("minute" starts flashing). Press the "SET" button to set the correct minute.
6. Press the "MODE" button again to confirm the time and date.

Measuring blood pressure

1. Wrap the cuff around the arm (refer to "Attaching the pressure cuff").
2. Sit upright on a chair (refer to „Posture during measurement“).
3. Press the "SET" button to select a particular memory store number.
4. Then press "START/STOP" to start automatic measurement.

When taking repeat measurements, be sure to select the same memory store number before pressing "START/ STOP".

1. The cuff is inflated. When the pulse is detected, the PULSE symbol will start flashing.
2. After the measuring procedure has been completed, the blood pressure values (systolic pressure and diastolic pressure) along with the pulse and WHO classification indicator will be shown on the display for 1 minute. After approx. 1 minute without being used, the unit will automatically switch off.

To interrupt the measurement, you may press the START/STOP buttons. The cuff will deflate immediately after a button is pressed.

Irregular Heartbeat Detector

If the symbol appears, it means the unit has detected an irregular pulse during measurement. If the symbol appears regularly please consult a qualified doctor for professional advice.

Storing data

EN

After each blood pressure measurement, the blood pressure values, pulse rate, time and date will be automatically stored. Each of the three memory stores saves the latest 30 measurements. If more than 30 measurements are saved, the memory will automatically delete the earliest values.

Recalling data:

1. Press the "MEMORY" button. A particular memory store will appear on the display.
2. Press the "SET" to find the correct memory store.
3. Press the "MEMORY". The average value of the last three measurements is shown by the following symbol: A. If no values have been stored, nothing will appear on the display. The most recently measured value will be displayed first.
4. By pressing the "MEMORY" button again you can view each of the saved values in the selected memory store.
5. After viewing the saved measurements, press "MEMO-RY" again to switch back to the initial display.
6. You can also switch back to the initial display by pressing the "START/STOP" button.

Erasing data:

1. Press the "SET" button to select User 1 or 2 or 3.
2. Press the "MEMORY" button to enter the Memory Mode.
3. Press and hold the "MODE & SET" buttons together, all stored date in the selected user will be erased.
4. To confirm the deletion, press the "MEMORY" button and no date should appear.

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 device/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.

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.

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.
Do not press the "START/STOP" button if the cuff has not been properly wrapped around the arm.

EN

	Replace batteries: Replace all 4 batteries with new ones. Insert the batteries in correct polarities.
EE	Appears when measurement error occurs or blood pressure value is displayed excessively low or high: Measure again. Wrap the cuff correctly and keep the arm still during measurement.
E1	Air circuit deviation. Cuff tube may not be plugged into monitor correctly: Check cuff connection. Measure again.
E2	Pressure exceeds 300 mmHg: Turn the unit off to clear, then measure again.
E3	Measurement data that result in an error message: Measure again.
EP	Return the device to your local distributor or to Geratherm.

EN

Model No. GT-868UF
Display System	Liquid Crystal Display
Measuring Method	Oscillometric
Power Source	4 alkaline "AA" type batteries (1.5 V) or AC adapter (Input: 230 V, AC, 50 Hz; Output: 6 V, DC, 1A)
Measuring Range	Pressure: 0 - 300 mmHg Pulse: 40 - 199 beats per minute
Accuracy	Pressure: ±3 mmHg Pulse: ±5 %
Infl ation Automatic
Defl ation Automatic exhaust valve
Memory	3 memory stores with 30 storage spaces each = total 90 stored values
Display LCD (date/time, pressure and pulse)
Low Battery Indicator	yes
Automatic switch-off	approx. 1 minute after last operation
Battery Life around 300 operations
IP Classifi-cation	IP22 (effective against solid foreign objects with a fi nger; protected against dripping water)
Cuff Size 23 to 33 cm / 9 to 13 inches
Operating Environment	+5 °C to +40 °C; RH 15 to 93 % (+41 °F to +104 °F)
Storage/Trans-port Environ-ment	-25 °C to +70 °C; RH ≤ 93 % (-13 °F to +158 °F)
Dimensions 110 x 150 x 80 mm (W x D x H)
Weight approx. 265 g (including batteries)

Specific cations are subject to change without notice for purposes of product improvement.

Geratherm® is certified in accordance with Council Directive 93/42/EEC and EN ISO 13485 and is entitled to affix the CE-mark 已 < 0197 (Notified Body: TUV Rheinland LGA Products GmbH).

The blood pressure monitor is compliant with

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.

DIN EN ISO 81060-1

Non-invasive sphygmomanometers - Part 1: Requirements and test methods for non-automated measurement type (ISO 81060-1)

DIN EN ISO 81060-2

Non-invasive sphygmomanometers - Part 2: Clinical investigation of automated measurement type (ISO 81060-2)

EN 1060-3

Non-invasive sphygmomanometers - Part 3: Supplementary requirements for electro-mechanical blood pressure measuring systems

Symbol index

Follow the instructions for use	BF	Type BF Equipment
Keep dry	LOT	Batch code (mm/yyy; month/year)
93% Store at a max. relative humidity of 93 %	SN	Serial number
+70°C Store between -25 °C and +70 °C		Manufacturer
-25°C The device must not be disposed of with household waste		Caution! Read the instruction manual.

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 defines 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 2W , 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 domestic establishments, 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 fluctuations / flicker 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 be used 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 eldIEC 61000-4-8	3A/m 3A/m		Power frequency magnetic fi eldsshould 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 disturbances are 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 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	0.12	0.12	0.23
0.1	0.38	0.38	0.73
1	1.2	1.2	2.3
10	3.8	3.8	7.3
100	12	12	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 reflection from structures, objects and people.

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 f 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 of equipment 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 reflection from structures, objects and people.

Guidance and manufacturer's declaration - electromagnetic immunity
a)	Field strengths from fixed 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 fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field 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, field strengths should be less than 3 V/m.

Geratherm Medical AG

Fahrenheitstrasse 1

98716 Geschwenda

Germany

C€0197

Que signifi e hypotension?

Geratherm Medical AG

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98716 Geschwenda

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Geratherm Medical AG

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Alemania

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INSTRUÇÉS DE UTILIZAZão

GT-868UF

C€0197

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Geratherm Medical AG

Fahrenheitstraße 1

98716 Geschwenda

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Fahrenheitstr. 1

Geschwenda 98716

Deutschland

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Fahrenheitstraße 1

D-98716 Geschwenda

Germany

Phone: ++49 36205 980

Fax: ++49 36205 98 116

www.geratherm.com

PUBDEM00402

2016-07