BM1006 - Blood pressure monitor LAICA - Free user manual and instructions

USER MANUAL BM1006 LAICA

DBP-2220 Instructions and warranty

5) Battery compartment

WarningIn compliance with European legislation on medical devicesProhibition European RepresentationCaution! Read the user instructions carefullySwiss representativeSymbol for "Type BF applied parts" (the cuff is type BF applied part) LOT Batch production number Serial numberManufacturerIP22: 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). 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

English WRIST BLOOD PRESSURE MONITOR - TYPE DBP-2220 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 product 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. Should the instruction manual get mislaid or you require additional information or clarifications, please fill in the relevant form on the website: https://www.laica.it/ in the FAQ and Support section.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 DESCRIPTIONINSTRUCTIONS FOR USEMAINTENANCETROUBLESHOOTINGDISPOSAL PROCEDUREWARRANTYSTANDARDSpag. 23pag. 23pag. 25pag. 26pag. 27pag. 30pag. 30pag. 32pag. 32pag. 33 English EN24 25

• 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”).

• 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 mix 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. 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 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 (wrist circumference from approx.

13.5 to 21.5 cm). To measure a child's blood pressure, consult your physician.

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),

• 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,

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

• Precision: systolic, diastolic ±3 mmHg heart rate ±5% of reading

• Memories: 60 memories per area (2 areas)

• Wrist circumference: between approx. 135 and 215 mm

• Power supply: 2 x 1.5V AAA alkaline batteries (LR03)

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

• Environmental conditions for use: from +10°C to +40°C; relative humidity between 15% and 93% RH

• Environmental conditions for storage: from -25°C to +70°C; relative humidity ≤93% RH

• Atmospheric pressure for use and storage: 700 hPa - 1060 hPa

• 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

The blood pressure monitor works with 2 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.

SETTING MEMORY ZONE AND DATE/TIME

1) With the unit off, press the “O/I” button for 3 seconds, the display will flash the last memory zone selected

" or " "). To select the memory zone desired, press the “M” key and confirm your choice by pressing the “O/I” button. At this point, the display flashes the number for the year (fig.2). Use the “M” key to adjust the figure, holding it down will speed up the scrolling of the numbers. Press the “O/I” button to confirm it.

2) Now the month flashes: adjust with the “M” key and confirm by pressing the “O/I” button.

3) Now the day flashes: adjust with the “M” key and confirm by pressing the “O/I” button.

4) Now the hour flashes: adjust with the “M” key and confirm by pressing the “O/I” button (the display shows

the time in 12 and 24 hour formats, see step 6 to select the desired format).

5) Now the minute flashes: adjust with the “M” key and confirm by pressing the “O/I” button.

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)

5) Battery compartment

• Product name: Blood pressure monitor

• Commercial name: BM1006

• Classification: Internally powered, Type BF applied part, IP22, No AP or APG, Continuous operating mode

1) 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.

2) 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 280 mmHg).

3) 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.

4) 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 This unit has the capacity to store up to 60 measurements in each memory zone (2 memory zones). After each measurement, the following values will be stored automatically: diastolic, systolic, pulse rate, date and time, memory number, segments for classifying blood pressure values (see “CLASSIFICATION OF BLOOD PRESSURE VALUES” section) and the possible presence of irregular heartbeat (arrhythmias) ( ) when the heart symbol is shown. To recall the stored measurements in the last memory zone selected, you must press the “M” key. On the display will appear ( ) or ( ). To scroll through the data in memory press the “M” key again (each press of the key scrolls through the data) and there will appear in succession:

• the word “AVG” which indicates the average of the last 3 measurements

• in the lower right of the display the memory number

• the stored values The number “60” is the oldest measurement, while the number “1” indicates the most recent value. Switch off the appliance by pressing the “O/I” button. After more than 60 measurements, the oldest data are automatically cancelled. To recall the memory area other than the last one selected before the last measurement, with the unit off it is necessary to hold the “O/I” button for 3 seconds. On the display the last memory zone selected will flash ( or ). Press the “M” key to select one of the two memory zones and

6) At this point, the display shows “US” or “EU” that indicates the format of date and time (US = 12-hour

format, EU = 24-hour format). Select the format with the “M” key and confirm by pressing the “O/I” button.

7) Press the “O/I” button for 3 seconds to confirm the data and turn off the display.

When you insert or replace the batteries you need to reset the memory zone, date and time as described in steps 1 to 7.

1) Open the velcro wrist strap.

2) Wrap the cuff around the bare wrist 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 from the palm of your hand, which should be facing upward, resting on a surface. The cuff should fit snugly around the wrist but should not be pulled too tightly; leave enough room to insert a finger between the cuff and wrist. If the cuff is too tight or too loose, the blood pressure 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 (13.5 – 21.5 cm) corresponds to the wrist circumference.

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. Use the case or similar object to support the forearm. 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.

6) Readings should always be taken at the same time to allow a comparison of blood pressure

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"

EnglishEnglish EN30 31 Problem Possible cause Solution After pressing the "O/I" key the reading does not start. 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. 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. confirm the selection by pressing the “O/I” button. At this point, turn off the unit by pressing and holding the “O/I” button for about 3 seconds.

DELETION OF STORED DATA

Deleting all data stored in a memory zone. When the appliance is turned off recall your memory zone by pressing the “O/I” button for 3 seconds and then the “M” key to select the memory zone and confirm by pressing the “O/I” button. Then switch off the unit, holding down the “O/I” button for about 3 seconds. At this point, press the “M” key and then the “O/I” button for about 3 seconds, the unit will emit a short beep and the display will show “---”. Now all the data in the previously selected memory zone will have been deleted. 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. Do NOT press the “O/I” key if the cuff is not wrapped around the wrisf. 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). 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.

EnglishEnglish EN32 33 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 60601-1:2005 +A1:2012(E)/EN 60601-1:2006/ A11:2011 (Medical electrical equipment - Part 1:General requirements for basic safety and essential performance), IEC 60601-1-2:2007/EN 60601-1-2:2007/AC:2010 (Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests), IEC 80601-2-30:2009+AMD1:2013/EN 80601-2-30:2010/ A1:2015 (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). Manufactured by: JOYTECH Healthcare Co., Ltd., No.365, Wuzhou Road, Yuhang Economic Development Zone, 311100, Hangzhou, China Shanghai International Corp. GmbH (Europe) Eiffestrasse 80, 20537 Hamburg, Germany MedEnvoy Switzerland Gotthardstrasse 28 6302 Zug - Switzerland Distributed by: Laica S.p.A. Viale del Lavoro, 10 - 36048 Barbarano Mossano (VI) - Italy Phone [phone] - [e-mail] - www.laica.it Made in China 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

EnglishEnglish EN34 35 Guidance and manufacture’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 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. RF emissions CISPR 11 N/A The DEVICE is suitable for use in all establishments domestic included 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 ELECTROMAGNETIC COMPATIBILITY Table 1 - For all ME EQUIPMENT and ME SYSTEMS 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)

± 8 kV contact ± 2 kV, ± 4 kV, ± 8 kV, ± 15 kV air ± 8 kV contact ± 2 kV, ± 4 kV, ± 8 kV, ± 15 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; 50 Hz or 60 Hz 3 A/m; 50 Hz or 60 Hz Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment. Table 2 - For all ME EQUIPMENT and ME SYSTEMS36 37 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 Radiated RF IEC 61000- 4-3 385MHz, 27V/m 450MHz, 28V/m 710MHz, 745MHz, 780MHz 9V/m 810MHz, 870MHz, 930MHz 28V/m 1720MHz, 1845MHz, 1970MHz 28V/m 2450MHz, 28V/m 5240MHz, 5500MHz, 5785MHz 9V/m 385MHz, 27V/m 450MHz, 28V/m 710MHz, 745MHz, 780MHz 9V/m 810MHz, 870MHz, 930MHz 28V/m 1720MHz, 1845MHz, 1970MHz 28V/m 2450MHz, 28V/m 5240MHz, 5500MHz, 5785MHz 9V/m Portable and mobile RF communications equipment should be used no closer to any part of the DEVICE, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Recommended separation distance: 80 MHz to 800 MHz 800 MHz to 2,7 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 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: Table 3 - For ME EQUIPMENT and ME SYSTEMS that are not LIFE-SUPPORTING Recommended separation distances between portable and mobile RF communications equipment and the DEVICE The DEVICE is intended for use in an electromagnetic environment in which radiated RF 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

For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be determined 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. NOTE 1 At 80 MHz and 800 MHz, the separation distance for 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. Table 4 - For ME EQUIPMENT and ME SYSTEMS that are not LIFE-SUPPORTING38 39NORMESCOMPATIBILITÉ ÉLECTROMAGNÉTIQUEpage 49page 50

PROBLEMAS E SOLUÇÕES

Part 3: Supplementary requirements for electro-mechanical blood pressure measuring systems).