Desktop GP6621 - Blood pressure monitor Geratherm - Free user manual and instructions

Features	Details
Product type	Blood pressure monitor
Measurement mode	Automatic blood pressure measurement
Measurement range	Systolic pressure: 0 to 299 mmHg, Diastolic pressure: 0 to 199 mmHg
Accuracy	±3 mmHg for pressure
Display	LCD screen with digital display
Memory function	Storage of measurements for multiple users
Power supply	Batteries (type not specified)
Dimensions	Compact, suitable for home use
Usage	Easy to use, suitable for personal or medical use
Maintenance	Regular cleaning of the device, checking batteries
Safety	Do not use on people with circulatory problems without medical advice
Warranty	Check warranty conditions with the manufacturer

Frequently Asked Questions - Desktop GP6621 Geratherm

How to calibrate the Geratherm Desktop GP6621 blood pressure monitor?

To calibrate the blood pressure monitor, follow the instructions in the user manual. Ensure the device is at a stable room temperature and perform a calibration test with a reference device if necessary.

What to do if the blood pressure monitor does not turn on?

Check that the batteries are correctly installed and not depleted. Replace the batteries if necessary and ensure the blood pressure monitor is properly connected if it is a rechargeable model.

How to interpret the displayed blood pressure results?

The displayed results include two numbers: the systolic pressure (the upper number) and the diastolic pressure (the lower number). A normal pressure is generally considered to be around 120/80 mmHg.

What to do if the results are inconsistent?

Make sure the cuff is properly positioned on the arm, you are relaxed and sitting comfortably. Repeat the measurement after a few minutes. If inconsistencies persist, consult the manual or contact customer service.

Can the Geratherm GP6621 blood pressure monitor be used by multiple people?

Yes, the Geratherm GP6621 can be used by multiple users, but it is recommended to keep separate records of measurements for each user to avoid confusion.

How to clean the blood pressure monitor?

Use a soft, dry cloth to clean the casing. Do not immerse the device in water and avoid harsh chemicals.

What does the error message on the screen mean?

An error message can indicate various issues, such as a mispositioned cuff or a measurement failure. Consult the user manual for specific instructions on the displayed error code.

How often should I measure my blood pressure?

It is recommended to measure your blood pressure at regular intervals as advised by your healthcare professional. Generally, daily measurement can be helpful to track changes.

How to change the battery of the blood pressure monitor?

Open the battery compartment located at the back of the device, remove the old batteries and replace them with new ones respecting the indicated polarity.

Is the blood pressure monitor guaranteed?

Yes, the Geratherm GP6621 is generally covered by a warranty. Check the warranty details in the manual or contact the seller for more information.

USER MANUAL Desktop GP6621 Geratherm

• 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 90 %, as this can lead to inaccurate readings.

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

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

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

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

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

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

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

• 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,26

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

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

• The blood pressure measurements conducted with this unit are equivalent to measurements obtained by a trained observer in accordance with the values achieved using the cuff/stethoscope auscultation method and are within the specifi ed DIN EN ISO 81060-2 standard limits.

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

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

• Do not use this appliance on infants, children or 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.

• 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. Precautions27

Warranty Information you should know before operating the unit 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 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. Severe hypertension (Grade 3) Moderate Hypertension (Grade 2) Mild Hypertension (Grade 1) Optimal Normal High - normal What is blood pressure? A force is created by the heart as the ventricle forcibly ejects blood into the blood vessels and through the trans- port system. Another force is created by the arteries as they resist the blood fl ow. Blood pressure is the result of these two forces. What are systolic and diastolic pressures? Systolic pressure represents the highest pressure at the height of the heart‘s contraction. Diastolic pressure is the lowest pressure when the heart is resting. Is my blood pressure normal? See the following blood pressure classifi cation chart re- leased by the WHO (World Health Organization) for evalu- ation of your blood pressure level. Diastolic mm Hg Systolic mm Hg28

Information you should know before operating the unit What about low blood pressure? In general, a lower blood pressure reading is better unless it causes some uncomfortable symptoms such as fainting and/or lightheadedness. Fluctuation and variation in blood pressure The following chart shows possible blood pressure fl uctua- tions during a 24hr period. The following factors will infl uence blood pressure meas- urement results and cause variations.

About the Unit The cuff is designed to fi t arm sizes between 22 and 32cm (8.7 to 12.6 inches.) Cuff On/Off Button LCD Display Memory Button Installing/Replacing Batteries

1. Insert the batteries into

low battery indicator ap- pears.

3. Remove the batteries if

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

4. REMOVE all of the BAT-

TERIES when utilizing the optional AC adapter. Note: It is recommended that the same type of alka- line batteries be used to avoid incompatibility. Keep batteries away from small children. Do not throw batteries into fi res: they could explode. Preparation for Use access for power supply30

Preparation for Use Attaching the Pressure Cuff

1. Wrap the cuff around the left

arm. The arm should be bare skin.

2. Fasten the cuff. Don‘t pull it

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

3. Attach the cuff on the right

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

1. Sit upright and ensure that the

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

2. Measure and record blood pressure at the same time

every day to establish your blood pressure pattern. AC Adapter (accessory) Use the device only with a medical approved stabi- lized AC adapter (Input: 100~240 V, AC, 60/50Hz; Output: 6V, DC, 800mA). Note:

1. No batteries are required during operation using

2. If AC adapter power is interrupted during meas-

urement, the device must be reset by discon- necting the AC adapter from the device.

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.31

How to Operate the Unit To adjust the clock Press the memory key to adjust the values of the ”month”, “date”, “hour”, and “minute” when they are blinking. 1.Setting the Clock To enter the setting mode by press- ing and holding the memory key for over 3 seconds. The display will show a blinking year. Press the power key to adjust the year when it is blinking. Then press and release the memory key again, the “month” will appear and blink to be adjusted, and then “date”, “hour” and “minute” will fol- low up as you press and release the memory key again.

2. Measuring Blood Pressure

Press and release the POWER key to start measuring automatically ã Initial display ã Measuring and Buzzer sounds. ã Pumping When the measurement is fi nished, the display will show the measured blood pressure and pulse value. Press the power key to turn off the unit. Otherwise the unit will turn off automatically 150 seconds later.32

How to Operate the Unit Note: If the symbol appears, it means the unit has detected irregular pulse during measurement. If the symbol appears regularly please consult a qualifi ed physician for professional advice.

3. Recalling Memories

Press and release the MEMORY key to recall the last read- ing (Example: the no.7 memory). The display will show the memorized pressure and pulse value. Press and release the MEMORY key again to recall the no.6 memory. Press and release repeatedly to read the no 5, 4, 3, 2, 1 memorized pressures.33

You may erase one or all records in memory. Delete one record

1. Press and release MEMORY key to choose the record

that you wish to delete

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

3. Press and release the power key again.

After 3 beeps are heard, the unit erases the record. Delete all records

1. Press and release MEMORY key to choose the record

that you wish to delete.

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

3. Press and release the MEMORY key then the display

4. Press and release the POWER key. After 3 beeps are

heard, the unit erases all records. How to Operate the Unit34

Care and Maintenance Do not drop the unit. It is not shock-proof. Do not modify or disassemble the unit or the arm cuff. Do not twist the arm cuff. Use a cloth mois- tened with water or neutral detergent to clean the body of the unit and then wipe it dry.35

Care and Maintenance Avoid thinner, benzine, and other harsh cleaners. Keep the unit in a suitable place. Avoid high tempera- ture, direct sunlight, high moisture, and dust. Remove the batteries if the unit will not be used for a long time. Do not press the POWER button if the cuff has not been properly wrapped around the arm.36

The pressure measured was lower than 20 mm Hg. Please measure again. Excessive body movement is detected during measurement. Please measure again. Pumping error. Please check cuff and try again. The pressure can not be measured due to signal noise. Please measure again. The pumping pressure is higher than 300 mm Hg. Please measure again. Low battery. Check and replace the 4 batteries if necessary. Error Messages Observe the applicable regulations when disposing of the device and batteries. This product must not be disposed of together with domes- tic 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 ac- ceptable manner. Please remove the batteries before disposing of the de- vice/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. Disposal37

Model no. GP-6621 Display System Liquid Crystal Display Measuring Method Oscillometric Power Source 4 alkaline “AA“ type batteries (1.5 V) or AC adapter (input: 100~240 V, AC, 60/50 Hz; output: 6 V, DC, 800 mA) Measuring Range Blood pressure: 20 to 300 mmHg Heart pulse rate: 40 to 200 pulse beats/min Accuracy Blood pressure: Heart pulse rate: ±3 mm Hg pulse rate: ±5 % Infl ation Micro rolling pump Pressure Exhaust Electric solenoid valve Memory 85 sets Display LCD (year/date/time, pressure and pulse) Low Battery Indicator Yes Auto Power-Off 150 secs. without any operation Battery Life Around 250 measurements Protection Level IP20 (protected against foreign bodies < 12,5 mm) Cuff Size 22 to 32 cm / 8.7 - 12.6 inches Operating Environment +5 °C to +40 °C; RH 15 % to 90 % (+41 °F to +104 °F) Storage Environment -25 °C to +55 °C; RH 15 % to 90 % (-4 °F to +122 °F) Dimensions 171 mm x 139 mm x 54 mm Weight around 550 g (including batteries) Specifi cations Specifi cations are subject to change for improvement without notice.38

Quality Standard Geratherm

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

• EN 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 essen- tial 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 systems Symbol index Follow the instruc- tions for use Type BF Equipment Keep dry Batch code (mm/yyyy; month/year) Store between 15 % and 90 % R.H. Serial number Store between -25 °C and +55 °C Manufacturer The device must not be disposed of with household waste. Important! Read the instruction manual!

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 po- tentially 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 maxi- mum 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 de- vices whose maximum power exceeds 2 W, the minimum distance from your blood pressure monitor should be 3.3 metres. Annex40

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 interfer- ence 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 sup- plies 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 typicalcommer- cial 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 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 transmit- ter in watts (W) according to the transmitter manufacturer. NOTE 1: At 80 MHz and 800 MHz, the separation distance for the higher fre- quency 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.41

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

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 propagation 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/cord- less) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fi xed RF transmitters, an electromagnetic site survey should be considered. If the measured fi eld strength in the location in which the device is used exceeds the applicable RF compliance level above, the device should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the device. b) Over the frequency range 150 kHz to 80 MHz, fi eld strengths should be less than 3 V/m. Annex Geratherm Medical AG Fahrenheitstraße 1 99331 Geratal Germany www.geratherm.comFR Tensiomètre numérique à écran de contrôle