BM2301 - Blood pressure monitor LAICA - Free user manual and instructions

USER MANUAL BM2301 LAICA

11) Battery compartment

Warning ManufacturerProhibition Serial numberCaution! Read the user instructions carefully LOT Production batch numberSymbol for "Type BF applied parts" (the cuff is type BF applied part)Keep dry!

In compliance with European legislation on medical devices SAFETY WARNINGS

• Prior to use, ensure the product is intact and that there is no visible damage. If in doubt, refrain from using the product and contact the retailer that sold you the product.• Keep the plastic bag away from children: danger of suffocation.• This device must be used only for its intended purpose and according to the user instructions. All other types of use shall be considered inappropriate and therefore hazardous. The manufacturer shall not be deemed liable for any damage caused by inappropriate or incorrect use.• People with physical, sensory or mental disabilities or unskilled people, may use and perform maintenance on the product only under adult supervision. Children must not play with the device. • To prevent the possibility of accidental strangulation, keep the device away from children and avoid wrapping the cuff around the neck.• Handle the product with care, protect it against accidental impact, extreme temperature fluctuations, humidity, dust, direct sunlight and sources of heat.• In the event of a failure and/or malfunction, turn off the device without tampering with it. Always contact your retailer for repairs.• Ensure hands are dry when using the on and off key. NEVER submerge the product in water or any other liquids.CAUTION! PRIOR TO USING THIS DEVICE• This device can measure blood pressure in adults, 18 years and older (arm circumference from approx. 22 to 36 cm). To measure a child's blood pressure, consult your physician. DO NOT use this device if you are suffering from severe arhytmia.• Measuring your own blood pressure is a way of monitoring it and must not be considered a diagnosis or treatment. Unusual readings must always be discussed with your physician. Under no circumstances should you alter the dosages of any medication prescribed by your physician.• Consult your physician prior to using the device in the following cases: • patients with heart pacemakers, • patients with an irregular heartbeat (arrhythmia), • pregnant women,• when applying the device on an arm wound or injury,• when applying the device on a limb where there may be an intravascular access device or arteriovenous shunt (A-V),• when applying the device on a person that has had a mastectomy,• when using the blood pressure monitor at the same time as other medical monitoring devices already being used on the same limb,• when undergoing dialysis treatment,• when taking anticoagulants, antiplatelets or steroids. • In the following cases, the reading may be lower or imprecise: arteriosclerosis, upper limb spasticity, low blood circulation, cardiovascular system disorders, very low blood pressure, blood flow disorders, arrhythmias and other pre-pathological conditions.• The device may give inaccurate readings if it is used in temperatures or humidity levels outside the limits indicated in the "Technical Specifications" paragraph.• Do not use near strong magnetic fields and therefore keep away from radio or mobile phone systems (for more information on interferences, see the paragraph “Electromagnetic compatibility information”).• Use only with the original manufacturer’s cuff. Use of non-original cuffs may lead to incorrect readings.SAFE USE OF BATTERIES• Remove the batteries if the device is not used for long periods of time and keep them in a well-ventilated and dry place, at room temperature. Do NOT rmix old and new batteries.• Use alkaline batteries only. Do NOT recharge the batteries if they are not rechargeable. Do NOT charge rechargeable batteries using methods other than those indicated in the manual or using unsuitable equipment. NEVER expose the batteries to sources of heat or direct sunlight. Failure to observe these instructions may result in damage to and/or the explosion of the batteries. EN EN English English18 19 Do NOT throw the batteries into an open flame.

• Batteries must always be removed or replaced by adults only.

• Keep batteries out of reach of children: the ingestion of batteries can cause serious harm and death. If a battery is swallowed, seek urgent medical care.

• The acid in batteries is corrosive. Avoid contact with the skin, eyes or garments.

CLASSIFICATION OF BLOOD PRESSURE READINGS

Blood pressure varies from person to person, rising and falling in each individual every day. It tends to rise with age and also depends on the individual’s lifestyle. After each blood pressure reading, the values will be compared with the following table prepared by the World Health Organization (WHO), the United Nations specialised health agency. The segments on the left of the display indicate the classification of blood pressure readings.

BLOOD PRESSURE CLASSIFICATION

SYSTOLIC (mmHg) DIASTOLIC (mmHg) SEGMENT COLOR OPTIMAL <120 <80 Green Normal 120 – 129 80 – 84 Green Normal – High 130 – 139 85 – 89 Green Ipertension 1st grade - Light 140 – 159 90 – 99 Yellow Ipertension 2nd grade - Moderate 160 – 179 100 – 109 Orange Ipertension 3rd grade - Severe ≥180 ≥110 Red Values below 105 mmHg (systolic) and 60 mmHg (diastolic) indicate hypotension. We recommend seeking medical advice. This device is able to detect irregular heartbeats, or arrhythmia, indicating them on the display with the symbol

Arrhythmia may be caused by frequent anxiety, certain emotional states, excessive alcohol use, genetic predisposition, age or other. It can be a symptom of a particular physical or mental condition (temporary disturbance) or an actual heart problem. Always seek medical advice if the monitor displays the irregular heartbeat symbol. PRODUCT DESCRIPTION (see fig.1)

11) Battery compartment

• Product name: Blood pressure monitor

• Commercial name: BM2301

• Classification: Internally powered, Type BF applied part, IP20

• Method: oscillometric, automatic air inflation and measurement

• Measurement range: from 0 to 300 mmHg (cuff pressure), from 30 to 180 beats/min (heart rate)

• Arm circumference: between approx. 220 and 360 mm

• Power supply: 4 x 1.5V AA alkaline batteries (LR06)

• Battery autonomy: approx. 2 months at 3 tests per day

• Environmental conditions for use: from +10°C to +40°C; relative humidity 15%~ 90% RH

• Environmental conditions for storage: from -20°C to +55°C; relative humidity 15%~ 90% RH

• The blood pressure monitor has been designed to maintain its performance and safety characteristics for approx 3 years at 10 test per day.

INSTRUCTIONS FOR USE

BATTERY INSERTION/REPLACEMENT

This blood pressure monitor works with 4 disposable 1.5V AA alkaline batteries. At first use, insert the batteries. Open the battery compartment sliding the cover in the arrow direction, then insert the batteries according to the indicated poles and close the cover. 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 flat. Dispose of worn batteries as described in the “Disposal procedure” paragraph.

1) With off device, press the “SET” key; the last selected memory area ( ,

, ) blinks on the display. To select the desired memory area, press the keys “-” “+” and confirm the selection pressing the “SET” key. Now, the number related to the month blinks on the display. Use the keys “+” and “-” to adjust this value: by keeping them pressed, the scrolling of the numbers becomes faster. Press the “SET” key to confirm it.

2) Then set the day, hours and minutes (the display shows the time in 12-hour

format). Adjust the data using the “+” and “-“ keys and confirm using the “SET” key.

3) Then, turn off the device pressing the “O/I” key. When batteries are inserted

or replaced, it is necessary to set the date and time once again.

1) Open the cuff’s velcro strap without pulling it out of the ring.

2) Insert the left arm into the cuff as shown in the “Wrapping the cuff” figure

and block it by closing the velcro strap. The edge of the cuff should be about 1-2 cm above the elbow and the palm of your hand should be facing upward, resting on a surface. Position the air hose at the centre of the cuff. The cuff should fit snugly around the arm but should not be pulled too tightly; leave enough room to insert a finger between the cuff and arm. If the cuff is too tight or too loose, the readings will be inaccurate. Never roll sleeves up or the blood flow will be obstructed and the reading will not be accurate. Make sure that the supplied cuff (22 - 36 cm) corresponds to the arm circumference. A cuff with circumference 30 - 42 cm is available: spare part code ABM008.

PROPER READING METHOD

For accurate blood pressure readings, follow these instructions:

1) Sit down, relax and keep still for at least 5 minutes before taking the reading.

2) Remove sleeves and jewellery from the arm and wrist before applying the

3) Avoid eating, smoking, drinking and exercising before taking the reading.

4) Always use the same arm (preferably the left one) to take the reading.

Rest the arm on a hard surface so that the cuff is level with the heart. The arm must be stretched out and relaxed. When the reading is being taken, do not move any part of the body or the blood pressure monitor. EN EN English English20 21

5) Rest both feet on the floor without crossing legs or feet.

The reading can also be taken when lying down. It is sufficient to lie on your back, applying the cuff level with the heart, with the palm of your hand facing upwards (see the “correct reading position” figure).

6) Readings should always be taken at the same time to allow a

comparison of blood pressure readings.

7) Do not rely on a single reading. We recommend taking at least two

readings at least 10/15 minutes apart. It is important to rest the arm during this time as blood congestion may result in false readings.

8) If unpleasant sensations are experienced during a reading, immediately turn

the device off using the "O/I" button.

1) Insert the air hose plug into the blood pressure monitor socket.

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. If there is still air in the cuff from the previous reading, the “ ” symbol will flash on the display for a few seconds.

3) The cuff will automatically inflate and will stop when it reaches the right level.

Try to stay relaxed, without speaking or moving. If the preset pressure (190 mmHg) is considered insufficient or if a hand movement is made, the device will start inflation over again (until a maximum of 250 mmHg).

4) The cuff will automatically inflate and the display will show the systolic and

diastolic pressure, heart rate, date and time of the reading. The ( ) symbol appears only in the event of an irregular heartbeat (arrhythmia). The segments on the left of the display indicate the classification of blood pressure readings.

5) The device will turn off automatically after about 3 minutes of non-use.

Otherwise, it can be turned off by pressing the “O/I” key. The reading can be interrupted by pressing the “O/I” key. Make sure the batteries are charged: worn or low batteries compromise the efficiency of the pump, which is subsequently unable to provide sufficient inflation pressure within the preset time range. For this reason, the monitor will display the ERR message. Therefore, replace the batteries. MEMORY FUNCTION The device can store up to 30 readings in each memory area (4 memory areas). After every reading, all values are automatically stored. To call up the measurements stored in the last selected memory area, it is necessary to keep one of the keys “+” or “-” pressed: the display shows the symbol “ ”, “ ”, “ ”, or “ ”. To scroll the stored data, press the key “+” or “-” and the following will appear in sequence:

• most recent to oldest readings: the number 01 indicates the most recent reading, the number 30 indicates the oldest. The device will turn off automatically after about 1 minute of non-use. Otherwise, it can be turned off by pressing the “O/I” key. After 30 readings, the oldest data will be automatically deleted. If there are no stored readings, the display will show “0 SYS 0 DIA”. To call up the own memory area, if different from the last one selected before the last measurement, it is necessary to press the key “SET” and select the desired memory area pressing the keys “+” and “-”; then, turn off the device by pressing the “O/I” key. Finally, it is possible to display the average values of the last 3 measurements performed. With off device, press the “-” key and keep it pressed until the device emits an acoustic signal. The display shows the message “AVG” indicating the average of the last 3 measurements performed. Attention: If there are 3 measurements for the memory area selected, it will not be possible to view the measurement average. In this case, the display will show the last measurement taken.

DELETING THE STORED DATA

Deleting all data stored in a memory area. With off device, call up the own memory area by pressing the “SET” key and then the keys “+” and “-“; then, turn off the device by pressing the “O/I” key. Now, keep the key “+” or “-“ pressed and then press the “SET” key for about 3 seconds; the device emits a short acoustic signal and the display shows “---“. Now all data related to the previously selected memory area have been deleted. To delete the data for another memory area, repeat the operation above, recalling the memory area involved. MAINTENANCE

• Store the device in its case in a well-ventilated and dry place without wrapping the hose too tightly and without resting any heavy objects on top of it.

• Clean the blood pressure monitor using a soft cloth, either dry or moistened with water and a liquid disinfectant.

• Never use chemicals or abrasives.

• NEVER wash the cuff in the washing machine and do not rub it vigorously, but rather delicately wipe the surface with a soft cloth, either dry or moistened with ethyl alcohol (75-90%) and leave it to dry naturally.

• Make sure liquids are never poured into the air hose. Do not press the "O/I" key if the cuff is not wrapped around the arm. DO NOT disassemble the device.

• It is recommended the performance should be checked every 2 years. Please contact the service Laica ( this is not included in warranty). TROUBLESHOOTING Problem Possible cause Solution After pressing the "O/I" key the reading does not start. The batteries have not been inserted properly. Check the correct positioning of the batteries. The batteries are worn. Replace them. Strong electromagnetic interference. Remove the batteries for 5 minutes and take the reading again. The display shows the dead battery symbol

The batteries are worn. If normal zinc-carbon batteries are used, they will need to be replaced more often Replace them. Use alkaline batteries to increase operating autonomy. The readings are very low or very high. The cuff is not correctly positioned. Re-read the “Wrapping the cuff” paragraph. Incorrect posture while taking the reading. Re-read the “Proper reading method” paragraph. During the reading, the person made a movement or spoke, or the reading was taken at a time when the person was particularly anxious or nervous. The heart rate readings are too low or too high. A movement was made during the reading. Re-read the “Proper reading method” paragraph. EN EN English English22 23 Problem Possible cause Solution The heart rate readings are too low or too high. The reading was taken after exercise. Re-read the “Proper reading method” paragraph. The symbol appears on the display. An irregular heartbeat was detected (arrhythmia). Repeat the reading, if the symbol appears again, seek medical advice. The display reads “Err”. The blood pressure monitor was unable to detect the systolic or diastolic pressure Do not move during readings. The cuff pressure has exceeded 300 mmHg. Wait 5 minutes, then take the reading again. If the display shows this error again, contact customer service. DISPOSAL PROCEDURE The symbol on the bottom of the device indicates the separated collection of electric and electronic equipment (Dir. 2012/19/Eu- WEEE). 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 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. To correctly dispose of batteries (Dir. 2013/56/Eu) do not throw them into household waste but rather dispose of them as special waste at specialised recycling centres. For more information about disposal of used batteries, contact the store where you purchased the equipment containing the batteries, the municipality or the local waste disposal service. WARRANTY This appliance is guaranteed for 2 years from the time of delivery of the goods, or another longer term envisaged by the national legislation of the consumer's residence. This provision complies with Italian and European legislation. The Laica products are designed for home use and must not be used in public venues. The warranty only covers manufacturing defects and does not apply if the damage is caused by an accidental event, incorrect use, negligence or misuse of the product. Use only the accessories supplied; the use of different accessories may result in invalidity of the warranty. Do not open the unit for any reason; in the case of opening or tampering, the warranty is definitively voided. This warranty does not apply to parts subject to wear or to the batteries when supplied. After 2 years from delivery, or another longer term envisaged by the national legislation of the consumer's residence, the warranty expires; in this case, the technical assistance interventions will be carried out against a fee. Information on technical assistance, whether under warranty or for a fee, can be requested by contacting [e-mail]. No payment will be due for repairs or replacements of products that fall within the terms of the warranty. In the event of faults, contact the retailer. Do NOT send the appliance directly to LAICA. All the operations under warranty (including those of replacement of the product or part thereof) will not prolong the duration of the original period of warranty of the product replaced. The manufacturer declines any liability for any damage that may, directly or indirectly, be caused to persons, property or animals as a result of the non-observance of all the requirements established in the relevant instructions manual and concerning, especially, warnings relating to installation, use and maintenance of the appliance. Laica, in its constant commitment to improving its products, is entitled to changing without any notice, in whole or in part, its products in relation to production requirements, without this entailing any liability for Laica towards its dealers. For further information: www.laica.it. STANDARDS This device complies with European standards and meets the following major standards (including but not limited to): EN 60601-1 Medical electrical equipment part 1: General requirements for safety. EMC standard: EN 60601-1-2 Medical Electrical Equipment -- Part 1-2: General Requirements For Basic Safety And Essential Performance -- Collateral Standard: Electromagnetic Disturbances – Requirements And Tests. Performance standards: IEC81060-2-30, Medical electrical equipment – Part 2-30: Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers, EN 1060- 3 Non-invasive sphygmomanometers - Supplementary requirements for electromechanical blood pressure measuring systems, EN 1060-4 Non-invasive sphygmomanometers - Test procedures to determine the overall system accuracy of automated non-invasive sphygmomanometers, ISO 81060-2, non-invasive sphygmomanometers - part 2: clinical validation of automated measurement type. EN EN English English24 25 Guidance and manufacturer’s declaration - electromagnetic emissions The DEVICE is intended for use in the electromagnetic environment specified below. The customer or the user of the DEVICE should assure that it is used in such an environment. Emissions test Compliance Electromagnetic environment – guidance RF emissions CISPR 11 Group 1 The DEVICE 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 DEVICE 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/A Guidance and manufacturer’s declaration – electromagnetic immunity The DEVICE is intended for use in the electromagnetic environment specified below. The customer or the user of the DEVICE 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. Recommended separation distances between portable and mobile RFcommunications equipment and the DEVICE The DEVICE is intended for use in an electromagnetic environment in which radiated therefore disturbances are controlled. The customer or the user of the DEVICE can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the DEVICE 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

PROBLEMAS E SOLUÇÕES

part 1: General requirements for safety.