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

Technical Features	Electronic upper arm blood pressure monitor, measures systolic and diastolic blood pressure, heart rate.
Display	LCD screen with clear result display.
Memory Capacity	Stores up to 60 measurements for two users.
Power Supply	Operates with batteries (type AA) or power adapter.
Usage	Easy to use, suitable for adults, instructions included in the manual.
Maintenance	Clean with a soft cloth, do not immerse in water.
Safety	Do not use on people with circulatory problems without medical advice.
Warranty	2-year warranty against manufacturing defects.
General Information	Device complies with CE standards, ideal for regular blood pressure monitoring.

Frequently Asked Questions - Easy Med GT868UF Geratherm

How to calibrate the Geratherm Easy Med GT868UF blood pressure monitor?

The blood pressure monitor is pre-calibrated at the factory. If you think it needs calibration, please contact Geratherm customer service for further assistance.

Why won\'t my blood pressure monitor turn on?

Make sure the batteries are correctly inserted and not depleted. Replace them if necessary.

How to use the blood pressure monitor correctly?

For an accurate measurement, sit in a quiet place, place the cuff on your arm at heart level, and follow the on-screen instructions.

What to do if the displayed results seem incorrect?

Check that the cuff is properly positioned and that you are in a relaxed position. Try again after a few minutes. If the problem persists, consult the user manual or contact support.

Can the blood pressure monitor be used by multiple users?

Yes, the Geratherm Easy Med GT868UF can store data for multiple users. Please refer to the manual to learn how to switch users.

How to clean the blood pressure monitor?

Use a soft, damp cloth to clean the casing. Do not immerse the blood pressure monitor in water and do not use harsh chemicals.

Where to find the model number of the blood pressure monitor?

The model number is usually located on the back of the device or on the label inside the battery compartment.

What is the battery life of the Geratherm Easy Med GT868UF?

Battery life depends on usage, but generally, they can last several months with regular use.

What to do if the cuff is too small or too large?

Make sure to use the correct cuff model recommended for your blood pressure monitor. If necessary, obtain a cuff of the appropriate size.

How to reset the blood pressure monitor?

To reset the blood pressure monitor, remove the batteries for a few minutes, then reinsert them. This will reset the device.

USER MANUAL Easy Med GT868UF Geratherm

Precautionary measures

• 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 ad- vice 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 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 meas- urement.

• 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 meas- urement 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 inter- lock 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 meas- urement.28

• 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 fa- miliar 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 disor- ders, 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 specifi ed DIN EN ISO 81060-2 standard limits.

• If the cuff causes any discomfort during the measure- ment, press the “START/STOP” 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 per- sons 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. Precautionary measures29

Precautionary measures

• Measuring too frequently may result in circulatory dis- orders, which can cause unpleasant sensations such as localised bleeding under the skin or temporary numbness in your arm. These symptoms do not usu- ally 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 instru- ment in any liquids.

• Do not use the instrument if you think it is damaged or if you notice anything unusual. 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 as- sembly, 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 im- proper 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.30

Diastolic mmHg Systolic mmHg 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 vas- cular 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 released by the WHO (World Health Organization) for evaluation of your blood pressure level. Severe Hypertension (Grade 3) Moderate Hypertension (Grade 2) Mild Hypertension (Grade 1) Optimal Normal High - Normal 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

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. 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 infl uence blood pressure meas- urement results and cause variations. Bathing, Breathing, Conversation, Drinking alcohol, Ex- ercise, Moving, Mental tension, Eating, Temperature changes, Thoughts, Smoking etc. Information you should know before operating the unit LCD DISPLAY SET BUTTON

CUFF CONNECTION ARM CUFF (AA) 1,5 V x 4 ALKALINE BATTERIES The cuff is designed to fi t arm diameters between 23 and 33 cm / 9 to 13 inches. About the unit32

About the unit Explanation of the display Preparation for use Installing/replacing batteries

1. Insert the batteries into the battery compartment match-

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. Systolic rate Diastolic rate Puls rate Low battery Error icon Icon for users 1, 2, 3 Pulse symbol WHO pressure bar indicator Number of memory spaces Irregular heartbeat detector Hour:Minute Day/Month33

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

1. Wrap the cuff around the left arm. The arm should be

2. Fasten the cuff. Don’t pull it too strongly or make the

cuff too tight. The edge of the cuff should be approxi- mately 1 inch from the crease of your elbow.

3. Attach the cuff on the right arm as shown in the fi gure

if it is not possible to measure on the left arm. Preparation for use34

Preparation for use AC adapter Use the device only with a medical approved stabi- lized AC adapter (input: 230 V, AC, 50 Hz; output: 6 V, DC, 1 A). Note:

1. No batteries are required during operation using

2. If AC adapter power is interrupted during meas-

urement, the unit must be reset by disconnecting the AC adapter from the unit.

3. Only use medical approved adapters that com-

ply with the specifi cations in this manual. Using other adapters could cause damage your blood pressure monitor. Posture during measurement

1. Sit upright and ensure that the measuring site 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.35

Operations 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 fl ashing).

Press the “SET” button to set the correct month.

3. Press the “MODE” button again (“date” starts fl ashing).

Press the “SET” button to set the correct date.

4. Press the “MODE” button again (“hour” starts fl ashing).

Press the “SET” button to set the correct hour in 12- hour format.

5. Press the “MODE” button again (“minute” starts fl ashing).

Press the “SET” button to set the correct minute.

6. Press the “MODE” button again to confi rm the time and

date. Measuring blood pressure

1. Wrap the cuff around the arm (refer to “Attaching the

2. Sit upright on a chair (refer to „Posture during meas-

3. Press the “SET” button to select a particular memory

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

5. The cuff is infl ated. When the pulse is detected, the

PULSE symbol will start fl ashing.

6. After the measuring procedure has been completed,

the blood pressure values (systolic pressure and di- astolic pressure) along with the pulse and WHO clas- sifi cation 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 defl ate immedi- ately after a button is pressed.36

Operations Irregular Heartbeat Detector If the symbol appears, it means the unit has detected an irregular pulse during measurement. If the symbol ap- pears regularly please consult a qualifi ed doctor for pro- fessional advice. Storing data After each blood pressure measurement, the blood pres- sure values, pulse rate, time and date will be automati- cally 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 earli- est values. Recalling data:

1. Press the “MEMORY” button. A particular memory

store will appear on the display.

2. Press the “SET” to fi nd the correct memory store.

3. Press the “MEMORY”. The average value of the last

three measurements is shown by the following symbol: . If no values have been stored, nothing will appear on the display. The most recently measured value will be displayed fi rst.

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 press-

Observe the applicable regulations when dispos- ing 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 house- hold waste, but at a battery collection station at a recycling site or in a shop. DISPOSAL Storing data 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 confi rm the deletion, press the “MEMORY” button

and no date should appear.38

Do not drop the unit. It is not shock-proof. Do not modify or disas- semble 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. Care and maintenance39

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. Do not press the “START/STOP” button if the cuff has not been properly wrapped around the arm.40

Error messages Replace batteries: Replace all 4 batteries with new ones. Insert the batteries in correct polarities.

Appears when measurement error oc- curs or blood pressure value is displayed excessively low or high: Measure again. Wrap the cuff correctly and keep the arm still during measurement.

Air circuit deviation. Cuff tube may not be plugged into monitor correctly: Check cuff connection. Measure again.

Pressure exceeds 300 mmHg: Turn the unit off to clear, then measure again.

Measurement data that result in an error message: Measure again.

Return the device to your local distributor or to Geratherm.41

Specifi cations 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) Specifi cations are subject to change without notice for purposes of product improvement.42

Quality standard Geratherm

is certifi ed in accordance with Council Direc- tive 93/42/EEC andEN ISO 13485 and is entitled to af- fi x the CE-mark CE 0197 (Notifi ed Body: TÜV Rheinland LGA Products GmbH). The blood pressure monitor is compliant with

• EN 60601-1+A1 Medical electrical equipment. Part 1: General require- ments for basic safety and essential performance.

• IEC/EN 60601-1-11 Medical electrical equipment. Part 1-11: General re- quirements 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: Require- ments and test methods for non-automated measure- ment 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: Supple- mentary requirements for electro-mechanical blood pressure measuring systems43

Follow the instructions for use Type BF Equipment Keep dry Batch code (mm/yyyy; month/year) Store at a max. relative humidity of 93 % Serial number Store between -25 °C and +70 °C Manufacturer The device must not be disposed of with household waste Caution! 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 medi- cal 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 de- vices whose maximum power exceeds 2 W, the minimum distance from your blood pressure monitor should be 3.3 metres.45

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 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 establish- ments, including domesticestablishments, and those directly connected to the public low-voltage power supply networkthat supplies buildings used for domestic purposes. Harmonic emissions

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)

± 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

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 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

For transmitters rated at a maximum output power not listed above, the recommended separa- tion 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 propaga- tion is affected by absorption and refl ection from structures, objects and people. Annex46

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

3 Vrms 150 kHz to 80 MHz 3 Vrms d= 1.2 √P Radiated RF

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 recom- mended 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.

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. Geratherm Medical AG Fahrenheitstrasse 1 98716 Geschwenda GermanyFR Tensiomètre tout automatique à bras