TES 4650 - Blood pressure monitor Orbegozo - Free user manual and instructions

USER MANUAL TES 4650 Orbegozo

INTRODUCTION Thank you for having chosen a blood pressure monitor ORBEGOZO. The unit uses the oscillometric method of blood pressure measurement. It means the unit detects the movement of your blood through your brachial artery, and converts your blood pressure into a digital reading. The unit is simple to use because a stethoscope is not needed while using an oscillometric monitor. The unit stores automatically 60 sets of measurement values. You can read the stored data conveniently by pressing the memory button. The unit comes with the following components: main unit, arm cuff and instruction manual

SYMBOLS IN THIS MANUAL AND PRODUCT

Indicates a potentially hazardous situation which, if not avoided, could result in death or serious injury.

Indicates a potentially hazardous situation which, if not avoided, may result in minor or moderate injury to the user or patient or damage to the equipment or other property.

Authorised representative in the European community

Refer to instruction manual/booklet

The marking of electrical and electronics devices according to Directive 2002/96/EC. The device, accessories and the packaging have to be disposed of waste correctly at the end of the usage. Please follow Local Ordinances or Regulations for disposal.TES 4650

USING AND SAFETY INSTRUCTIONS

To assure the correct use of the product basic safety measures should always be followed including the precautions listed below: Read all information in the instruction manual and any other literature included in the box before using the unit. Contact your physician for specific information about your blood pressure. Self-diagnosis and treatment using measured results may be dangerous. Follow the instructions of your healthcare provider. Operate the unit only as intended. Don't use for any other purpose. The unit is intended to use in measuring blood pressure and pulse rate for adult only, not recommended for neonatal baby at home or medical centre. Do not use a cellular phone near the unit. It may result in operational failure. Please avoid using in high radiant area in order to make your measuring data correctly. Do not disassemble or attempt to repair the unit or components. Do not use the equipment where flammable gas (such as anesthetic gas, oxygen or hydrogen) or flammable liquid (such as alcohol) are present.

When the unit detects an irregular rhythm two or more times during the measurement, the irregular heartbeat Symbol will appear on the display with the measurement values.

An irregular heartbeat rhythm is defined as a rhythm that is more than 25% slower or 25% faster from the average rhythm detected while the monitor is measuring the systolic blood pressure and the diastolic blood pressure. If the Irregular Heartbeat Symbol (IHB) displays with your measurement results, we recommend you consult your physician. Follow the directions of your doctor.

BEFORE TAKING A MESUREMENT

Follow these instructions before taking a measurement:

1. Avoid eating, drinking alcohol, smoking, exercising and bathing for 30 minutes before taking a

2. Stress raises blood pressure. Avoid taking measurements during stressful times.

3. The cuff can be applied to your left or right wrist. Always measure your blood pressure on the same

4. Measurements should be taken in a quiet place.

5. Position the unit at heart level throughout the measurement.

6. Remain still and do not talk during the measurement.

7. Keep a record of your blood pressure and pulse readings for your physician. A single measurement

does not provide an accurate indication of your true blood pressure. You need to take and record several readings over a period of time. Try to measure your blood pressure at the same time each day for consistency.

8. Wait 30-60 seconds between measurements. The wait time allows the arteries to return to the

condition prior to taking the blood pressure measurement. You may need to increase the wait time depending on your individual physiological characteristics.loading-circle-1TES 4650

1. Remove the battery cover from the battery compartment.

2. Install 4 “AA” size batteries so the + (positive) and - (negative) polarities match the polarities of the

battery compartment as indicated.

3. Replace the battery cover.

1.1. All information will appear when the batteries are installed at the first time. After 2 seconds the year flashes. Finally, press the “SET” button and continue with step 2. 1.2. The mark of year appears and flashes after press the “SET” button for 3~4 seconds, while the unit is off. Finally, press the “SET” button again and continue with step 2. Press the “MEM” button to increase one year. Press the “SET” button to decrease one year. Long press the button and the value quickly changes.TES 4650

2. To set date and time

Press the “MEM” button to change the month and press the “SET” button and continue with next step. Then set the day, the hour and the minute by using the same way. Continue with step 3.

Then press the “MEM” button again to change the current unit.

Press the “START STOP” button to save the current setting and turn offTES 4650

Make sure the air plug is inserted properly in the main unit.

Remove all clothes from your upper arm allowing the cuff to fit directly on the skin.

Sit in a chair with your feet flat on the floor. Place your arm on a table so as to level the cuff to your heart.

Pass the end of the cuff through the metal, and keep the hose outward.

Put your arm through the loop, then pull it up to the position of your upper arm.

The hose runs down the inside of your arm. The bottom of the cuff should be approximately 1-2cm above your elbow.

Wrap the cuff tightly around your upper arm by using the Velcro strip. Do not leave any spacing between the arm and the cuff.

Relax your arm, keep the palm upward and the fingers curving naturally, then turn on the unit and start to measure.TES 4650

2. Inflation stop automatically and the measurement is started. The heartbeat symbol flashes once a pulse is

Start to inflate Inflating Maximun inflating

3. The blood pressure and pulse rate are displayed when the measurement completed. The cuff is deflated

automatically, and all of the measurement results are stored in the memory with date and time. The “IHB” symbol will be displayed if irregular heartbeat is detected. kPa display mmHg display IHB displayTES 4650

you have forgotten to turn it off.

NOTE: To stop the inflation or measurement, press the “START-STOP” button in anytime. The unit will stop inflating and then release and turn off. INSTRUCTIONS FOR SPECIAL CONDITIONS: In order to accelerate the measurement time for the systolic pressure more than 180 mmHg, press and hold the memory button until the unit inflates 30 to 40 mmHg higher than your suspected systolic pressure if you know. (The unit will not inflate above 299 mmHg).

USE THE MEMORY FUNCTION

The unit stores the blood pressure and pulse rate in the memory after completing a measurement every time. It can automatically store 60 sets of measurement values. The oldest record is deleted to save the latest measurement value when more than 60 sets. The unit also calculates an average reading based on the values of the latest 3 times measurement taken

1. To read the average value

Press the “MEM” button. The average value symbol will display.

2. To read the measurement value

Press the “MEM” button to view the latest measurement value with the measuring date and time. Press the “SET” button to view the oldest measurement value with the measuring date and time.TES 4650

3. To delete the memory value

In the memory reading mode, press the “SET” button for 4-6 seconds the unit will display Press the “SET” button again and LCD will display If you are sure all the data of corresponding user can be deleted, press the “START-STOP” button. All the corresponding user’s data will be deleted and the unit will turn off. Note: if you have set , but do not press a button for 2 minutes, the product will shut off automatically, but the corresponding user’s blood pressure data will not be deleted. The delete operation must be confirmed by user.

ABOUT BLOOD PRESSURE

Blood Circulation The blood circulation is responsible for supplying the body with oxygen. Blood pressure is the pressure exerted on the arteries. The systolic blood pressure value (higher pressure or top value) represents the blood pressure produced by contraction of the heart muscle. The diastolic blood pressure value (lower pressure or lower value) represents the blood pressure produced by relaxation of the heart muscle. Health and blood pressure The incidence of hypertension increases with age. In addition, a lack of exercise, excess body fat and high levels of cholesterol (LDL), which sticks to the inside in blood vessels, reduces elasticity of these vessels. Hypertensioin accelerates arterial sclerosis which can lead to very serious conditions such as stroke and myocardial infarction. For these reasons it is very important to know whether the blood pressure is within a healthy range. Blood pressure fluctuates from minute to minute, throughout the day. Therefore it is essential to take regular measurements to help you identify an average blood pressure.TES 4650

Classification of blood pressure After each measurement is completed, the LCD display will show your position automatically on the six segments of the bar indicator which corresponds to World Health Organization (WHO) Blood Pressure Indicator. *Note! When a person’s systolic and diastolic pressures fall into different categories, the higher category should apply.

Symptoms of high blood pressure High blood pressure can go unnoticed for a long time, since it does not cause noticeable symptoms. The following are all possible causes of abnormally high blood pressure: Overweight High cholesterol level Smoking Excessive alcohol consumption Stress and emotional upset Excessive consumption of saltTES 4650

Lack of physical exercise Genetic/hereditary predisposition Underlying illnesses, such as kidney disorders or endocrine disturbance Treatment of high blood pressure If your blood pressure reaches upper values of 140-160 mmHg and lower values of 90-95 mmHg in repeated measurements over several days, you should consult your doctor for detailed medical examination. You can assist the treatment prescribed by your doctor in the following ways: Lose weight and lower you cholesterol level Reduce the consumption of alcohol and salt Stop smoking Take regular exercise Monitor your blood pressure

The course of inflating appears error. Wrap the cuff correctly and tightly. Ensure the connection is close between the air plug and the unit. Inflate over again after ensuring. When measurement fails. Do not move your arm and body, and keep quiet. Measure over again according to correct way.

When the batteries power are too low. Replace all of the worn batteries with new ones.

ELIMINATE FAULT PROBLEM

CAUSES AND SOLUTIONS

No power. Replace all the worn batteries with 4 new ones. No display appears on the display screen. Check the battery installation for proper placement of the batteries polarities. Measurement values appear too high or too low. Blood pressure varies constantly. Many factors including stress, time of day, how you wrap the cuff, may affect your blood pressure. Review the sections "Proper Use of the Arm Cuff" and "Take a Measurement".

Keep the unit in the storage case when not in use. Clean the unit with a soft dry cloth. Do not use any abrasive or volatile cleaners. Never immerse the unit or any components in water. If needed, please use ultraviolet radiation for disinfection. Avoid subjecting the monitor to strong shocks or vibrations, such as dropping the unit on the floor. MaintenanceTES 4650

The unit is intended to be used to measure blood pressure (systolic and diastolic) and heart rate from the upper arm by using the oscillometric method. The unit is intended for using in only adult population, not applied to the other populations such as neonatal baby. It can’t be used while the wirst (arm) has bleeding or wound to avoid the blood flowing from the wound in pressurzing. STATEMENT The unit satisfies the requirements of IEC60601-1 Medical electrical equipment, EN1060-1: Non-invasive sphygmomanometer, EN1060-3: Non-invasive sphygmomanometer. The unit has passed the EMC test. The Unit complies with IEC 80601-2-30. The risk of patient and user can be lowered to acceptable level. Substitution of a cuff different from that supplied might result in measurement error. Specifications are subject to change without notice due to improvements in performance. The unit might not meet its performance specifications if stored or used outside the following specified temperature and humidity ranges. ADDITIONAL INFORMATION Protection Class: Internally powered equipment Applied Part Type: Type B Moisture Protection: IPX0, continue operation

WARNING: No modification of this equipment is allowed.

Caution: this machine should not be used adjacent to or stacked with other equipment and that if adjacent or stacked use is necessary, this machine should be observed to verify normal operation in the configuration in which it will be used. Caution: This unit has been thoroughly tested and inspected to assure proper performance and operation! The unit satisfies the requirements of - EN60601-1：Medical electrical equipment Part 1: General requirements for basic safety and essential performance; - EN60601-1-2: Medical electrical equipment Part 1-2: General requirements for basic safety and essential performance – Collateral standard: Electromagnetic compatibility – Requirements and tests; - EN1060-1: Non-invasive sphygmomanometers – requirements; - EN1060-3: Non-invasive sphygmomanometers – Part 3: Supplementary requirements for electro-mechanical blood pressure measuring system. - EN1060-4：Non-invasive sphygmomanometers – Part 4: Test procedures to determine the overall system accuracy of automated non-invasive sphygmomanometers. MEDICAL ELECTRICAL EQUIPMENT needs special precautions regarding EMC and needs to be installed and put into service according to the EMC information provided in this manual

WARNING: The use of other accessories, transducers and cables other than those provided may result in

increased emissions or decreased immunity of the equipment.TES 4650

Sensitive measuring devices must be checked from time to time for accuracy and leakage. We recommend that the performance should be checked every 2 years.

GUIDANCE AND MANUFACTURE’S DECLARATION

ELECTROMAGNETIC EMISSION The Digital Blood Pressure Monitor is intended for use in the electromagnetic environment specified below. The customer of the user of the Digital Blood Pressure Monitor should assure that it is used in such an environment. Emission test Compliance Electromagnetic environment – guidance Radio frequency (RF) emissions CISPR 11 Group 1 The Digital Blood Pressure Monitor use RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment. RF emissions CISPR 11 Class B The Digital Blood Pressure Monitor is suitable for use in all establishments other than domestic and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes. Harmonic emissions

Not applicable Voltage fluctuations/flicker emissions

ELECTROMAGNETIC IMMUNITY The Digital Blood Pressure Monitor is intended for use in the electromagnetic environment specified below. The customer or the user of Digital Blood Pressure Monitor should assure that it is used in such an environment. 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 aie Floors should be wood, concrete or ceramic tile. If floor are covered with synthetic material, the relative humidity should be at least 30%. Power frequency (50Hz/60Hz) magnetic field IEC 61000-4-8 3 A/m 3 A/m Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment. Radiated RF

3 A/m Portable and mobile RF communications equipment should be used no closer to any part of the Digital Blood Pressure Monitor, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Recommended separation distance d=1.167√P 80 MHz to 800 MHz d=2.333√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 fixed 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 of equipment marked with the following symbol:TES 4650

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.

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 Digital Blood Pressure Monitor is used exceeds the applicable RF compliance level above, the Digital Blood Pressure Monitor should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the Digital Blood Pressure Monitor.

Over the frequency range 150 KHz to 80 MHz, field strengths should be less than 3V/m Recommended separation distances between portable and mobile RF communications equipment and the Digital Blood Pressure Monitor. Pressure Monitor is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the Digital Blood Pressure Monitor can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the Digital Blood Pressure Monitor as recommended below, according to the maximum output power of the communications equipment. Output power of transmitter Separation distance according to frequency of transmitter (m)

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.TES 4650

DISPOSAL OF OLD ELECTRICAL APPLIANCES

The European directive 2012/19/EU on Waste Electrical and Electronic Equipment (WEEE), requires that old household electrical appliances must not be disposed of in the normal unsorted municipal waste stream. Old appliances must be collected separately in order to optimize the recovery and recycling of the materials they contain, and reduce the impact on human health and the environment. The crossed out “wheeled bin” symbol on the product reminds you of your obligation, that when you dispose of the appliance, it must be separately collected. Consumers should contact their local authority or retailer for information concerning the correct disposal of their old appliance. DECLARATION OF CONFORMITY: This device complies with the requirements of the Low Voltage Directive 2014/35/EU and the requirements of the EMC directive 2014/30/EU. GUARANTEE This appliance is covered and is entitled to the legal guarantee in accordance with the legislation in force from the date of purchase. Keep the purchase receipt to be able to claim your right to the guarantee. To find the closest service to your location, contact through the following web link: https://orbegozo.com/asistencia- tecnica/ For any type of query, doubt or incident, you can contact us through our email shown on the main page of this manual or through our technical assistance service at https://orbegozo.com/contacto/ Orbegozo is not responsible for components and accessories that are subject to wear and tear due to use, as well as perishable compounds or those that have deteriorated due to improper use. Nor will it be held responsible if the owner has technically modified the device. Check the legal conditions on our website.TES 4650

INDICATIONS DE L’ÉCRAN LCD

INDICAÇÕES DO ECRÃ LCD