BM2006 - Blood pressure monitor LAICA - Free user manual and instructions

USER MANUAL BM2006 LAICA

PERFORMING A MEASUREMENT

• Dimensioni: 132x100x63 mm

• Dimensions: 132x100x63 mm

This device, completely automatic, is used to measure and control in a non-invasive way the value of blood pressure (systolic and diastolic) and the heart rate. Blood pressure is the force exerted by blood on the arteries. This force varies constantly depending on heartbeat. When the heart contracts, blood pressure is at its highest (systolic blood pressure value) whilst at the end of the heart’s “relaxation period”, the value is at its lowest (diastolic blood pressure value). Circuits within the cuff sense the small oscillations in pressure against the cuff produced by the expansion and contraction of the arteries in the arm in response to each heart beat. The amplitude of each pressure waves is measured, converted to millimeters of mercury, and displayed on the LCD as a digital value. Blood pressure is influenced by many factors: smoke, stress, physical activity, eating, the time of day… Accurate and easy to use, this device enables even the elderly and less expert to measure blood pressure in the comfort of their own home; its quick and reliable results enabling pressure values to be checked daily. Laica S.p.A. - Viale del Lavoro, 10 - Fraz. Ponte 36021 Barbarano Vicentino (VI) - ITALY Made in China BEFORE STARTING TO USE THE DEVICE, PLEASE READ THIS INSTRUCTION MANUAL CAREFULLY FROM COVER TO COVER AND KEEP IT SAFE FOR FUTURE REFERENCE.

• Self-measuring means checking, and is no substitute for diagnosis or treatment. Unusual values should always be discussed with your doctor. Under no circumstances should doses of any medicine prescribed by your doctor be altered.

• The heartbeat display is not suitable for checking the frequency of pacemakers!

• Should there be a deviation from the normal rhythm of the heart (arrhythmia) or other cardiac problems, for carriers of pacemaker, for those who use anticoagulants, for women in state of pregnancy, the measurements made with this device should be evaluated only after consulting your doctor. In such cases compare the results with the doctor in order to verify their correctness.

• Do not use this instrument without consultation with your doctor if you are under dialysis therapy or on anticoagulants, antiplatelets or steroids. Use of this instrument under such conditions could cause internal bleeding.

• In case of heavy arteriosclerosis and other circulation problems or spasms in the upper limbs the readings could result incorrect.

• This device cannot be used within the area interested by radiations of Computerized Axial Tomography (TAC), X rays and Magnetic Resonance (RMN).

• This appliance must be used solely for the purpose for which it was designed and in accordance with the operating instructions. Any other use shall be considered improper and hence hazardous. The manufacturer cannot be held responsible for any damage resulting English from improper or incorrect use.

• This device does not replace any product supplied to you by your practitioner or by other professionals. WARNING

1) If there is reduced blood circulation in the arm due to acute or chronic

vascular diseases (including the restriction of the diameter of the blood vessels), the precision of the measurement could be affected.

2) In the case of cardiocirculatory illnesses, the measurements could

be falsified; the same could happen with very low blood pressure, problems with blood supply, arrhythmia or other pre-pathological conditions.

3) Do not use near to strong magnetic fields.

It must be kept well away from radio equipment or mobile phones.

4) Pressure varies from person to person, and increases or decreases

every day, depending on the stress the heart is subjected to. Normally pressure is low during the night, during sleep or during relaxation, and it is higher during the day, when we smoke, during physical exercise, under effort, when we are anxious or tense. Blood pressure tends to increase with age and depends greatly on the individual way of life. It is well known that stress, obesity, excessive intake of salt and alcohol all contribute to increase arterial pressure. The blood pressure value measured at home tends to be lower than that measured at the hospital, in the clinic, or by your doctor. This occurs because one is usually anxious at the hospital and relaxed at one’s home.

5) Keep the batteries out of the reach of children.

Optimal 105 - 120 60 - 80 self-measurement Normal 121 - 130 81 - 85 self-measurement Limit range 131 - 140 86 - 90 refer to a physician High blood pressure (1st level) 141 - 160 91 - 100 refer to a physician High blood pressure (2nd level) 161 - 180 101 - 110 refer to a physician High blood pressure (3rd level) beyond 180 beyond 110 refer to a physician Measured values lower than 105 mmHg (systolic) and than 60 mmHg (diastolic) indicate a high blood pressure status. It is suggested to refer to a physician.

CORRECT MEASURING METHOD

Many factors determine variations in arterial pressure: physical exercise, eating, agitation, changes in temperature and emotional stress. Daily fluctuations of 25 / 50 mmHg are common. In order to get an accurate blood pressure reading, follow the instructions below:

1) Sit on a chair, relax and try to keep still for at least 5/10 minutes

before taking a reading. Instructions and guarantee English EN EN24 25

AUTOMATIC ARM BLOOD PRESSURE MONITOR

2) Remove clothing and jewellery from the arm or wrist before applying

3) Avoid eating, smoking and drinking (above all alcoholic drinks), sports

training and having a bath before performing the measurement. All these factors influence the measurement result.

4) Rest the arm on the table so that the armlet is on a level with the heart.

The arm must be stretched out naturally and must be kept still.

5) Place both feet on the ground.

6) Remember that the blood pressure changes during the day.

Try to effect more measurements during the day for better understanding the reactions of your body to the different moments of your day (after a physical activity, during the job, after the meals…).

7) Do not take only one measurement.

At least two measurements should be taken, wait at least 10/15 minutes between the two measurements. More measurements, taken over a long period of time will give you a better indication of your blood pressure.

8) Should an unpleasant feeling occur during the measurement, stop

immediately the device with the “O/I” button. IMPORTANT NOTE!

• The armlet must be kept on a level with the heart at all times, otherwise you will not get an accurate reading.

• To prevent the risk of accidental strangulation, keep this unit out of children’s reach and avoid wrapping the armlet around the neck.

• This unit is designed to measure adult pressure values to be used for people of 18 years and over (arm circumference roughly in the range 22 to 36 cm). If this instrument is applied to the arm of a child, the value measured may be inaccurate. Consult your doctor for measuring the arterial pressure of a child.

• We recommend using the left arm for taking the mea- surements.

• If the appliance is used in temperature and humidity conditions outside the limits given in the “Technical Features” the readings may not be accurate.

• Do not use the device in case of arm wounds or lesions.

INSERTING/REPLACING BATTERIES

1) Slide the battery cover in the direction of the arrow.

2) When installing or replacing the two batteries, insert them in accordance

with the polarity marked.

3) Place the cover back to its position. When the display shows the battery

symbol ( ), or the device emits 4 short acoustic signals and does not inflate the armband, it is necessary to replace the batteries since they are discharged.

4) Remove the run down batteries by lifting the cover of the battery

compartment located on the bottom of the device. Extract the batteries and dispose them as special waste at the specific collection points forecast for recycling. For more information about the disposal of English run down batteries, please contact either the store where the device containing the batteries was purchased, or the Municipality, or the waste disposal local service. Caution: For greater safety, children younger than 12 years should not remove the batteries. HOW TO WRAP THE ARMLET AROUND THE ARM

1) Rest the armlet on a flat surface with the fastener strip (Velcro) facing

down. Make sure the Velcro fastening is on your left and the armlet’s tube on your right.

2) Insert the end of the armlet through the ring at the other end by about

3) Wrap the armlet around the left arm and secure it in place using the

Velcro fastening. The edge of the armlet must be approx. 1-2 cm above the elbow joint and the palm of the hand must face up. The armlet must be snug around the arm (there must be enough room to fit one finger between the armlet and the arm), but not too tight. If the armlet is wrapped too tightly or is too loose, blood pressure readings may be inaccurate. Do not roll sleeves up the arm or blood flow will be impeded, resulting in inaccurate measurements.

HOW TO TAKE MEASUREMENTS

1) Plug the tube into the air connector.

2) Keep the “O/I” key pressed until you hear an acoustic signal. On the

display, all function symbols switch on, just for few seconds. The symbol “ ” indicates that the device is ready for the measurement. The armband will start to inflate automatically and will stop when the right level is reached. Caution: If after the last measurement some air remained in the armband, the display shows the symbol “ ” till the device stabilizes the pressure. Try to stay relaxed, without talking or moving.

3) The armband will deflate automatically and the display will show the

following values: systolic, diastolic and pulse. Automatic re-pressurisation The starting pre-set pressure level is 190 mmHg. If the pre-set pressure is insufficient in the preliminary reading phase or if the hand or wrist is moved, the unit will start inflating again until 250 mmHg are reached. Automatic re-pressurisation is repeated until a valid reading is taken. However this is not sign of a fault with the appliance.

4) Turn off the device pressing the “O/I” key.

If, for any reason whatsoever, you wish to interrupt the measurement, just press the “O/I” key and remove the armband. Make sure the batteries are charged. Low or dead batteries decrease the efficiency of the pump, which then cannot provide enough pressure in the preset time interval. For this reason, ERR will appear. Replace the batteries. MEMORY FUNCTION This device can store up to 120 measurements. After each measurement, the following values are stored automatically: diastolic, systolic and Instructions and guarantee English EN EN26 27

AUTOMATIC ARM BLOOD PRESSURE MONITOR

pulse values. To call up the stored measurements, it is necessary to keep the “M” key pressed with off device. On the bottom right corner of the display, the number of the last stored measurement will appear, followed by the stored data. Every time the “M” key is pressed, the data in the memory are scrolled. The number “120” corresponds to the oldest measurement, while the number “1” indicates the most recent value. After 120 measurements, the oldest data are deleted automatically. Turn off the device pressing the “O/I” key.

DELETING THE STORED DATA

To delete all stored data, it is necessary to call up the stored measurements keeping the “M” key pressed with off device. Now, keep the “O/I” key pressed until the display shows “- - -”. The device emits a short acoustic signal. Now, all stored data have been deleted. Turn off the device pressing the “O/I” key. Moreover, when the batteries are replaced, all measurements are deleted automatically. INDICATORS On the display, the following symbols may appear: Err: It was not possible to perform the measurement due to arm movements, wrong position, other reasons... See paragraph “Correct measuring method”. : Exhaust batteries. Replace them. : indicator of the pulse rate during the measurement

CARE AND MAINTENANCE

• This unit contains precision components. Hence, you should avoid exposing the unit to extreme changes in temperatures, humidity, knocks, dust and direct sunlight. Do not drop or hit the unit.

• Clean the unit using a soft, dry cloth only. Never use chemical or abrasive products. Since the armlet may absorb sweat and other fluids, check it carefully for signs of dirt or discolouring after each use. Do not wash the armlet in a washing machine and do not rub it vigorously. Use a dry cloth and gently wipe the surface clean. Take care never to let liquids get into the air tube. If this happens, dry the tube thoroughly with air.

• This device is not waterproof.

• Do not press the “O/I” key if the armlet is not wrapped around the arm.

• When the device is stored away, do not wind the rubber tube up too much and do not place any heavy items on top of the device. Store the device in the supplied case.

• If the device has been stored below freezing point, keep it in warm surroundings for at least 1 hour before using it. English

• Do not dismantle or modify the device.

• Place the device in the supplied case and, to store it, observe the environmental conditions stated here below. SPECIAL CASES If the following circumstances occur:

1) After pressing the “O/I” key the reading does not start.

• Check the batteries and replace them if needed

• Clean the contacts of the batteries with a dry cloth.

2) Nothing appears on the display when the “M” key is pressed.

• The batteries are flat.

3) The batteries do not last long.

• Use alkaline batteries to increase working autonomy. If normal zinc-carbon batteries are used they will need changing more often.

4) You cannot complete a reading.

• Check the batteries and change them if needed.

5) The blood pressure levels are different with each reading - the readings

are very low or very high.

• The measuring position is not correct Read the paragraph “Correct measuring method” again.

• The blood pressure readings vary constantly depending on the time of day and the state of nerves of the person. Read the paragraphs “Warnings” and “Important” again.

6) The heart beat readings are too high or too low:

• The person moved while the reading was being taken.

• The reading was taken after physical exertion. Read the paraghaphs “Correct measuring method”, “Warnings” and “Important” again. COMPONENTS

• Pressure indication range: between 0 and 300 mmHg (armband pressure) between 30 and 180 pulsations/min. (pulse frequency)

• Precision: ±3 mmHg (armband pressure) ±5% of the read value (pulse frequency)

• Inflating: automatic

• Power: 4 alkaline batteries 1.5 V AA type LR06 Instructions and guarantee English EN EN28 29

• Working conditions: between +10°C and +40°C; <85% relative humidity

• Storage conditions: between +10°C and +60°C; <95% relative humidity

• Arm circumference: between 220 and 360 mm approx.

• Dimensions: 132x100x63 mm

• Weight: about 330 g (without alkaline batteries) Important! Read the instructions carefully Type BF apparatus IP22: Degree of protection of electrical equipment covers, where the first figure indicates the degree of protection against penetration by solid foreign bodies (from 0 to 6) and the second figure the degree of protection against penetration by liquids (from 0 to 8). ELECTROMAGNETIC COMPATIBILITY This device complies with current regulations relating to electromagnetic compatibility (EMC) and has been designed to be used in the home. Its emissions are extremely small and are unlikely to generate interference with other equipment. In the event that it is to be used in close proximity to other equipment, it is recommended to follow the instructions given in the tables at the end of the instructions for use. Certain mobile communications devices and radio systems may have an effect on the operation of this device. In cases where there are anomalies during operation, it is recommended to distance the device from any other equipment that could cause electromagnetic interference and check for the restoration of performance. In all cases, in the event of doubt, contact Customer Support or see the tables relating to electromagnetic emissions at the end of these instructions. DISPOSAL PROCEDURE (Dir. 2012/19/Eu-WEEE) The symbol on the bottom of the device indicates the separated collection of electric and electronic equipment. At the end of life of the device, do not dispose it as mixed solid municipal waste, but dispose it referring to a specific collection centre located in your area or returning it to the distributor, when buying a new device of the same type to be used with the same functions. If the appliance to be disposed of is less than 25 cm, it can be returned to a retail location that is over 400 m2 without having to purchase a new, similar device. This procedure of separated collection of electric and electronic devices is carried out forecasting a European environmental policy aiming at safeguarding, protecting and improving environment quality, as well as avoiding potential effects on human health due to

English the presence of hazardous substances in such equipment or to an improper use of the same or of parts of the same. Caution! The wrong disposal of electric and electronic equipment may involve sanctions. WARRANTY This equipment is covered by a 2-year warranty starting from the purchase date, which has to be proven by means of the stamp or signature of the dealer and by the fiscal payment receipt that shall be kept enclosed to this document. This warranty period complies with the laws in force and applies only in case the consumer is an individual. Laica products are designed for domestic use only; therefore, their use for commercial purposes is forbidden. The warranty covers only production defects and does not apply, if the damage is caused by accidental events, misuse, negligence or improper use of the product. Use the supplied accessories only; the use of other accessories invalidate the warranty cover. Do not open the equipment for any reason whatsoever; the opening or the tampering of the equipment, definitely invalidate the warranty. Warranty does not apply to parts subject to tear and wear along the use, as well as to batteries, when they are included. Warranty decays after 2 years from the purchase date. In this case, technical service interventions will be carried out against payment. Information on technical service interventions, under warranty terms or against payment, may be requested by writing at [e-mail]. Repair or replacement of products covered by the warranty terms are free of charge. In case of faults, refer to the dealer; DO NOT send anything directly to LAICA. All interventions covered by warranty (including product replacement or the replacement of any of its parts) shall not be meant to extend the duration of the original warranty period of the replaced product. The manufacturer cannot be made liable for any damages that may be caused, directly or indirectly, to people, things and pets resulting from the inobservance of the provisions contained in the suitable user manual, especially with reference to the instructions related to installation, use and maintenance of the equipment. Being constantly involved in improving its own products, Laica reserves the right to modify its product, totally or partially, with reference to any production need, without that this involves any responsibility whatsoever by Laica or its dealers. Instructions and guarantee

Română70 71 Guidance and manufacturer’s declaration – electromagnetic immunity The BM2006 is intended for use in the electromagnetic environment specified below. The customer or the user of the BM2006 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 air Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30 %. Power frequency (50/60 Hz) magnetic field

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. Guidance and manufacturer’s declaration - electromagnetic emissions The BM2006 is intended for use in the electromagnetic environment specified below. The customer or the user of the BM2006 should assure that it is used in such an environment. Emissions test Compliance Electromagnetic environment – guidance RF emissions CISPR 11 Group 1 The BM2006 uses RF energy only for its internal function. Therefore, its emissions are very low and are not likely to cause any interference in nearby electronic equipment. RF emissions CISPR 11 Class B The BM2006 is suitable for use in all establishments, including domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes. Harmonic emissions

N/A Voltage fluctuations/ flicker emissions

N/A72 73 Guidance and manufacturer’s declaration - electromagnetic immunity The BM2006 is intended for use in the electromagnetic environment specified below. The customer or the user of the BM2006 should assure that it is used in such an environment. Immunity test IEC 60601 test level Compliance level Electromagnetic environment – guidance Conducted RF IEC 61000-4-6 Radiated RF

3 Vrms 150 kHz to 80 MHz 3 V/m 80 MHz to 2,5 GHz N/A 3 V/m Portable and mobile RF communications equipment should be used no closer to any part of the BM2006, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Recommended separation distance: 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 meters (m). Field strengths from fixed 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: Recommended separation distances between portable and mobile RFcommunications equipment and the BM2006 The BM2006 is intended for use in an electromagnetic environment in which radiated therefore disturbances are controlled. The customer or the user of the BM2006 can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the BM2006 as recommended below, according to the maximum output power of the communications equipment. Rated maximum output power of transmitter

Separation distance according to frequency of transmitter

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. NOTE1 To calculate the recommended separation distance of transmitters in the frequency range of 80 MHz and 800 MHz to 2.5 GHz, an additional factor of 10/3 has been used in order to reduce the probability of a mobile/portable communications BM2006 unintentionally introduced into the patient area causing a fault. NOTE2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.