BM2302 - Blood pressure monitor LAICA - Free user manual and instructions

USER MANUAL BM2302 LAICA

5) Battery compartment

English ARM BLOOD PRESSURE MONITOR TYPE KD-5923 INSTRUCTIONS AND WARRANTYDear customer, Laica would like to thank you for choosing one of our products, designed according to strict performance and quality criteria in order to ensure total satisfaction. IMPORTANTREAD CAREFULLY BEFORE USEKEEP IN A SAFE PLACE FOR FUTURE REFERENCEThe instruction manual must be considered an integral part of the product and must be kept for its entire life. If the appliance is transferred to another owner, its documentation must also be transferred in its entirety. To ensure the safe and correct use of the product, the user must carefully read the instructions and warnings contained in the manual insofar as they provide important information regarding safety, user and maintenance instructions. If the instruction manual is lost or in the event you require additional information or clarifications, please contact the company at the address shown below:Laica S.p.A. Viale del Lavoro, 10 - 36048 Barbarano Mossano (VI) - Italy - Tel. [phone] - [e-mail] - www.laica.it This completely automatic and non-invasive device measures and checks blood pressure (systolic and diastolic), the heart rate and checks for arrhythmias. CONTENTS KEY TO SYMBOLSSAFETY WARNINGSCLASSIFICATION OF BLOOD PRESSURE READINGSPRODUCT DESCRIPTIONpag. 14pag. 15pag. 16pag. 16INSTRUCTIONS FOR USEMAINTENANCETROUBLESHOOTINGDISPOSAL PROCEDUREWARRANTYSTANDARDSELECTROMAGNETIC COMPATIBILITYpag. 17pag. 18pag. 19pag. 20pag. 20pag. 21pag. 21

WarningIn compliance with European legislation on medical devicesProhibition Production dateCaution! Read the user instructions carefully. Background colour of the symbol: blue. Colour of graphic symbol: whiteSymbol for "Type BF applied parts" (the cuff is type BF applied part) Serial numberKeep dry! LOT Batch production numberManufacturer European Representation IP20: 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).

English 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 30 cm). To measure a child's blood pressure, consult your physician. DO NOT use this device if you are affected by severe arrhytmias.• 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 or lymph node removal,• 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,• when the user's blood circulation must be checked. • 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 (at least 30 cm) from radio or mobile phone systems (for more information on interferences, see the paragraph “Electromagnetic compatibility”).• Use only with the original manufacturer’s cuff. Use of non-original cuffs may lead to incorrect readings. Do NOT share the use of the cuff with persons with infectious diseases (risk of infection). Do NOT bend or pinch the air tube during the measurements so as to avoid possible errors of cuff inflation or bruising of the arm due to the continuous pressure in the cuff.• The device operator is the patient. Do not use this device if you are allergic to plastic and/or rubber. SAFE USE OF BATTERIES• Remove the batteries if the device is not used for long periods of time and keep them in a16 17 EN EN English English well-ventilated and dry place, at room temperature. 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. 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 CLASSIFICATIONSYSTOLIC (mmHg)DIASTOLIC (mmHg)SEGMENT COLOROptimal<120<80 BlackNormal120 – 12980 – 84 BlackNormal – High 130 – 139 85 – 89 BlackIpertension 1st grade - Light 140 – 159 90 – 99 Dark greyIpertension 2nd grade - Moderate 160 – 179 100 – 109 Light grey Ipertension 3rd grade - Severe ≥180 ≥110 White 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)

5) Battery compartment

• Product name: Blood pressure monitor

• Commercial name: BM2302

• Classification: Internally powered, Type BF applied part, IP20, No AP or APG, Continuous operating mode

• Method: oscillometric, automatic air inflation and measurement

• Measurement range: from 0 to 300 mmHg (cuff pressure), from 60 to 260 mmHg (systolic pressure), from 40 to 199 mmHg (diastolic pressure), from 40 to 180 beats/min (heart rate)

• Arm circumference: between approx. 220 and 300 mm

• Environmental conditions for use: from +10°C to +40°C; relative humidity ≤85% RH

• Environmental conditions for storage and transport: from -20°C to +50°C; relative humidity ≤85% RH

• Atmospheric pressure for use and storage: 80kPa-105kPa

• The blood pressure monitor has been designed to maintain its performance and safety characteristics for a minimum of 10,000 readings. The cuff has been designed to maintain its condition for around 1000 opening/closure cycles.

• The components belonging to the pressure measuring system (accessories included): pump, valve, LCD display, cuff and sensor.

INSTRUCTIONS FOR USE

BATTERY INSERTION/REPLACEMENT

This blood pressure monitor works with 4 disposable 1.5V AAA alkaline batteries.At first use and when the display shows the battery symbol , insert and/or replace the batteries. Open the battery compartment using the tab on the cover, then insert the batteries according to the indicated poles and close the cover. Dispose of worn batteries as described in the “Disposal procedure” paragraph.

1) When the device is switched off, press the “M” and “O/I” keys simultaneously for a few

seconds: the 24 or 12 hour time format will flash on the display. Use the “M” key to adjust the date and confirm using the “O/I” key.

2) Then set the year, month, day, hours and minutes. Adjust the data using the “M” key and

confirm using the “O/I” key. Press the “M” key to speed up the number scrolling. The display shows the hour and date. The date/time will need to be reset whenever the batteries are replaced.

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 - 30 cm) corresponds to the arm circumference. A cuff with circumference 30 - 42 cm is available: spare part code ABM002.

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 cuff.

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.

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 at18 19

EN EN English English 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

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

2) Press the “O/I” button. All function symbols will appear on the display for a few

seconds. The display will read “ ”, which indicates the first memory area; select the desired memory area using the “M” key and confirm with the “O/I” key. If no keys are pressed within 5 seconds, the monitor will automatically use the displayed memory area. The display reads

3) If there is still air in the cuff from the previous reading, the

symbol will flash on the display for a few seconds. 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 295 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 1 minute 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 readings, press the “M” key: the display will show the last memory area used, and in the lower left, the number of readings stored in that specific memory area. Select the desired memory area by pressing the “O/I” key and confirm by pressing the “M” key. To scroll the stored readings, press the “M” key and the following will appear in order:

• the reading average is indicated by the letter “AL” in the bottom left corner of the display,

• the morning reading average (from 5:00am-9:00am in the last 7 days) is indicated by the initials “A7”,

• the afternoon reading average (from 6:00pm-8:00pm in the last 7 days) is indicated by the initials “P7”,

• 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”.

DELETION OF SAVED DATA

It is possible to delete all saved readings: press the “M” key and when the display shows the reading average, press it again for approx. 3 seconds. The display will show and turn off automatically. It is not possible to delete stored data from a single memory area. 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.

• It is recommended to clean the cuff after about 200 uses. 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 service the device whilst operating.

• Before it is ready for use, the device takes about 6 hours to heat up from the minimum storage temperature (-20°C) to a room temperature of about 20°C.

• Before it is ready for use, the device takes about 6 hours to cool down from the maximum storage temperature (+50°C) to a room temperature of about 20°C. Do not press the "O/I" key if the cuff is not wrapped around the arm. Do NOT disassemble the device.

• It is recommended to check the performance of the device every 2 years or after repairs. Contact Laica service assistance (activities excluded from the warranty).

• Repairs of the blood pressure monitor should not be made by the user. In case of qualified and specialised technical personnel able to repair the components considered repairable, the manufacturer can provide the support material necessary to carry out such repairs (such as circuit boards, list of components, calibration instructions, etc.). TROUBLESHOOTING TECHNICAL ALARM The blood pressure monitor may display the messages “HI” or Lo” on the LCD display if the blood pressure reading (systolic or diastolic) is outside the range indicated in the “Technical Specifications” paragraph. In this case, it is recommended to consult the “Wrapping the cuff”, “Proper reading method” and “Taking a reading” paragraphs to check that the procedure has been properly carried out, and seek medical advice. The technical alarm limit values (outside the nominal range) are preset and cannot be adjusted or deactivated. These are priority values pursuant to standard IEC 60601-1-8. The technical alarm does not need to be reset, the signal that appears on the LCD display will automatically disappear after approx. 8 seconds. 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. The reading was taken after exercise.20 21 EN EN English English Problem Possible cause Solution 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 “Er 1” or “Er 2”. The blood pressure monitor was unable to detect the systolic or diastolic pressure Do not move during readings. The display reads “Er 3” or “Er 4”. The cuff is too tight or too loose. Wrap the cuff properly (see “Wrapping the cuff” paragraph) and take the reading again. The display reads “Er 5”. 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. The display reads “Er 6”. Cuff inflation lasts longer than 180 seconds. The display reads “Er A”, or “Er 0”, or “Er 7” or “Er 8”. There is a device or system error. 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

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 The product corresponds to the below standards: IEC 60601-1 Edition 3.1.2012- 08 EN 60601-1:2006/A1:2013 (Medical electrical equipment - Part 1:General requirements for basic safety and essential performance), IEC60601-1-2:2014 / EN 60601-1-2:2015 (Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests), IEC 80601-2-30:2018 / EN IEC 80601-2- 30:2019 (Medical electrical equipment - Part 2-30: Particular requirements for the basic safety and ssential performance of automated non-invasive sphygmomanometers) EN 1060-1:1995 + A2:2009 (Non-invasive sphygmomanometers - Part 1:General requirements), EN 1060-3:1997+A2:2009 (Non-invasive sphygmomanometers - Part 3: Supplementary requirements for electro-mechanical blood pressure measuring systems). ISO 81060-2:2013(Non-Invasive Sphygmomanometers - Part 2: Clinical Validation of Automated Measurement) Manufactured by: ANDON HEALTH CO., LTD. No. 3 Jinping Street, YaAn Road, Nankai District, Tianjin 300190, China. iHealthLabs Europe SAS 36 Rue de Ponthieu, 75008, Paris, France Distributed by: Laica S.p.A. Viale del Lavoro, 10 - 36048 Barbarano Mossano (VI) - Italy - Tel. [phone] - [e-mail] - www.laica.it Made in China Phenomenon Compliance Electromagnetic environmentRF emissionsCISPR 11Group 1, Class BHome healthcare environmentHarmonic distortionIEC 61000-3-2Class AHome healthcare environmentVoltage fluctuations and flickerIEC 61000-3-3ComplianceHome healthcare environmentELECTROMAGNETIC COMPATIBILITY INFORMATIONTable 1 - Emission2322 PhenomenonBasic EMC standardImmunity test levelsHome Healthcare EnvironmentElectrostaticDischargeIEC 61000-4-2±8 kV contact±2kV, ±4kV, ±8kV, ±15kV airRadiated RF EM field IEC 61000-4-310V/m80MHz-2.7GHz80% AM at 1kHzProximity fields from RF wireless communications equipmentIEC 61000-4-3 Refer to table 3Rated power frequency magnetic fields IEC 61000-4-830A/m50Hz or 60HTable 2 - Enclosure PortTest frequency (MHz) Band (MHz)Immunity test levelsProfessional healthcare facility environment385 380-390 Pulse modulation 18Hz, 27V/m450 430-470 FM, ±5kHz deviation, 1kHz sine, 28V/m 704-787 Pulse modulation 217Hz, 9V/m745

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