BM1007 - Blood pressure monitor LAICA - Free user manual and instructions

Product type	Blood pressure monitor
Brand	Laica
Model	BM1007
Measurement method	Oscillometric with automatic air inflation
Measurement range - cuff pressure	0 to 300 mmHg
Measurement range - systolic pressure	60 to 260 mmHg
Measurement range - diastolic pressure	40 to 199 mmHg
Measurement range - heart rate	40 to 180 pulses/min
Pressure accuracy	±3 mmHg
Heart rate accuracy	< 60 bpm : ±3 bpm ; ≥ 60 bpm : ±5%
Display	LCD, values in 1 mmHg
Memory	30 readings per zone, 4 zones
Wrist circumference	Approx. 14 to 19.5 cm
Power supply	2 alkaline 1.5V batteries type AAA (LR03)
Battery life	Approximately 200 readings
Operating conditions	+10°C to +40°C, humidity ≤ 85% RH
Storage conditions	-20°C to +50°C, humidity ≤ 85% RH
Atmospheric pressure	80 to 105 kPa
Service life	Minimum 10,000 readings (device), 1000 cycles (cuff)
Main functions	Measurement of systolic/diastolic blood pressure, heart rate, arrhythmia detection, WHO classification
Care	Clean with a soft dry cloth or slightly dampened with water and disinfectant; cuff: ethyl alcohol (75-90%)
Safety	Do not use on children, people with severe arrhythmia, pacemaker without medical advice; avoid any contact with water
Spare parts	Use exclusively the original cuff provided by the manufacturer
Warranty	2 years from delivery

Frequently Asked Questions - BM1007 LAICA

How to correctly place the cuff?

Open the hook-and-loop closure of the bracelet, slip it around your wrist as shown in the instructions. The cuff margin should be about 1 to 2 cm above your hand, palm facing up. The cuff should adhere well without being too tight: leave at least one finger gap between the cuff and wrist. Ensure that your wrist circumference is between 14 and 19.5 cm.

How to set the date and time on the BM1007 blood pressure monitor?

Simultaneously press the "M" and "O/I" buttons for a few seconds when the device is off. The screen displays the time format (12 or 24h). Use the M button to set, then O/I to confirm. Then set the year, month, day, hours, and minutes in the same way.

What to do if the battery symbol appears on the screen?

The battery symbol indicates that the batteries are exhausted. Replace the two alkaline batteries type AAA (1.5V) respecting polarity. Preferably use alkaline batteries for longer life (about 200 readings).

How to interpret the segments displayed on the left of the screen?

The segments indicate the classification of blood pressure values according to WHO. They range from optimal pressure (black segment) to severe hypertension (white segment). Compare your values with the table in the instructions to know your level.

What does the symbol (♥) on the screen mean?

The symbol (♥) indicates the presence of irregular heartbeats (arrhythmia). If this symbol appears regularly, consult a doctor. Arrhythmia may be temporary or related to heart disease.

How to delete stored data?

Press the M button until the screen displays the average of readings. Hold the M button for 3 seconds. The screen shows 'CL' then turns off automatically, deleting all data. It is not possible to delete only one zone.

What conditions must be observed for an accurate measurement?

Sit down and relax for at least 5 minutes before measurement. Do not eat, smoke, or drink. Always use the same arm (preferably left) placed at heart level. Do not move or talk during the measurement.

What to do in case of error message 'Er 1' or 'Er 2'?

These errors indicate that the blood pressure monitor could not measure systolic or diastolic pressure. This is often due to movement during measurement. Stay still and repeat the measurement. If the error persists, check the cuff position.

How to clean the blood pressure monitor and cuff?

Clean the monitor with a soft dry cloth or slightly dampened with water and liquid disinfectant. For the cuff, after approximately 200 uses, wipe the surface with a dry cloth or slightly dampened with ethyl alcohol (75-90%). Do not wash the cuff in a machine.

Can the blood pressure monitor be used by people with a pacemaker?

Yes, but it is essential to consult a doctor before use. The device can be used under medical supervision. Generally, people with severe arrhythmias should not use this device.

USER MANUAL BM1007 LAICA

MICA MISUBATORE DI PRESSIONE DA POLSO

HC71/d - 06/2022

LAICA®

LAICA S.p.A.

LAICA 74.4 8.5 M

ISTRUZIONI E GARANZIA

KD-7920

MISURATORE DI PRESSIONE DA POLSO pagin

Instructions and warranty page 20 WRIST BLOOD PRESSURE MONITOR
ES Instrucciones y garantía página 34 MEDIDOR DE PRESIÓN DE PULSO
Instruções e garantia página 48 MEDIDOR DE PRESSAO DE PULSO
Anleitungen und Garantie Seite 62 HANDGELENK-BLUTDRUCKMESSGERAT
Instructions et garantie page 76 TENSIOMETRE DE POIGNET
Οδηγίες και εγγύηση σελίδα 90 ΠΙΕΣΟΜΕΤΡΟ ΚΑΡΠΟΥ
RO Instructiuni și garantie pagina 104 TENSIOMETRU DE INCHEIETURA
Návod a záruka strana 118 TLAKOMER NA ZÁPESTÍ
Návod a záruka strana 132 TLAKOMER NA ZÁPÄSTIE
HU Használati utasítások és garancia oldal 146 CSUKLÓ VÉRNYOMÁSMÉRŐ

FIG.1

LAICA 1 14.4 9.5 M 2 3 4 5

EN PRODUCT DESCRIPTION

1) LCD DISPLAY

2 "M" key

2) "C4" bu

3) 61 button

4) Con

5) Battery compartment

6) Batteries

7 Case

6

7

ES DESCRIPCIÓN

DEL PRODUCTO

11 DISPLAY LCD

3) Tocke "M"

Correct reading position

Illustration of a person aiming a needle with an arrow, no text or symbols present

Simple line drawing of a person sitting at a desk using a device (no text or symbols)

Simple line drawing of a person sitting at a desk with hands placed on the table, no text or symbols present.

NO

MISURATORE DI PRESSIONE DA POLSOMISI

Illustration of a hand wearing a wristwatch with a belt, showing rotational motion arrows (no text or symbols)

1-2 cm

Illustration of a hand holding a wristwatch with a pressure gauge (no text or symbols)

IT

Italiano Italiano

MISURATORE DI PRESSIONE DA POLSO - TYPE KD-7920 ISTRUZIONI E GARANZIA

II prodotto risponde ai seguenti 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), IEC 60601-1-2:2014 / 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 essential performance of automated non-invasive sphygmomanometers) EN 1060-1:1995 + A2:2009 (Non-invasive sphygmomanometers - Part 1: General requirements), EN 1060-3:1897+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).

Prodotto da:

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

Dear 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.

IMPORTANT

READ CAREFULLY BEFORE USE

KEEP IN A SAFE PLACE FOR FUTURE REFERENCE

The 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 SYMBOLS	pag. 21
SAFETY WARNINGS	pag. 21
CLASSIFICATION OF BLOOD PRESSURE READINGS	pag. 23
PRODUCT DESCRIPTION	pag. 24
INSTRUCTIONS FOR USE	pag. 25
MAINTENANCE	pag. 27
TROUBLESHOOTING	pag. 28
DISPOSAL PROCEDURE	pag. 30
WARRANTY	pag. 30
STANDARDS	pag. 31
ELECTROMAGNETIC COMPATIBILITY	pag. 32

KET TO SYMBOLS

Warning Prohibit

Caution! Read the user instructions carefully. Background colour of the symbol: blue. Colour of graphic symbol: white

Symbol for "Type BF applied parts" (the cuff is type BF applied part)

Manufacturer

C€0197

In compliance with European legislation on medical devices

Production date

European Representation

Serial number

Batch production number

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).

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.

EN

English

• 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. 14 to 19.5 cm). To measure a child's blood pressure, consult your physician.

DO NOT use this device if you are affected by severe arrhythmias.

- 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 blood circulation should be monitored.

- 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").

English

EN

• 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).
  • 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 a well-ventilated and dry place, at room temperature.

Do NOT recharge the batteries if they are not recharocable.
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.
- Ballenes 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 Black
Normal 120 – 129 80 – 84	Black
Normal – High	130 – 139 85 – 89	Black
Ipertension 1st grade - Light	140 – 159 90 – 99	Dark grey
Ipertension 2nd grade - Moderate 160 – 179	100 – 109	Light grey
Ipertension 3rd grade - Severe	≥ 180	≥ 110	White

English

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)

1) LCD DISPLAY
2) "M" key
3) "O/I" key
4) Cuff
5) Battery compartment
6) Batteries
7) Case

TECHNICAL SPECIFICATIONS

The package includes: 1 blood pressure monitor, 1 instruction for use, 1 case, 2 batteries.

• Product name: Blood pressure monitor
• Commercial name: BM1007
• Classification: Internally powered, Type BF applied part, IP22, 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)

• Precision: systolic, diastolic ±3 mmHg
heart rate: <60: ±3bpm, >60 (incl.): ±5%
• Precision of the displayed values: 1 mmHg
• Memories: 30 memories per area (4 areas)
• Wrist circumference: between approx. 140 and 195 mm
• Power supply: 2 x 1.5V — AAA alkaline batteries (LR03)
• Battery autonomy: approx. 200 readings
• 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

English

• 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

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 by sliding the cover in the direction of the arrow, then insert the batteries according to the indicated poles and close the cover.
Dispose of worn batteries as described in the "Disposal procedure" paragraph.

DATE/TIME SETTING

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, minutes and date.
The date/time will need to be reset whenever the batteries are replaced.

WRAPPING THE CUFF

1) Open the velcm 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 fill snugly around the wrist but should not be pulled too lightly; 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 (14 - 19.5 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.

EN

English English

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 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. Too frequent measurements can cause injuries.
8) If unpleasant sensations are experienced during a reading, immediately turn the device off using the "0/1" button.

TAKING A READING

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 0.
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 i(♥) 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 "0/1" 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.
• 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.
  Do not service the device while is 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 "0/1" key if the cuff is not wrapped around the wrist.

English

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 clause 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.

English

Problem Possible cause Solution
The readings are very low or very high.	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.	Re-read the "Proper reading method" paragraph.
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 "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. If the display shows this error again, contact customer service.
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.

English English

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 m ^2 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), IEC 60601-1 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 essential 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: Lalca S.p.A.

Phenomenon Compliance Electromagnetic environment
RF emissions	CISPR 11Group 1, Class B	Home healthcare environment
Harmonic distortion	IEC 61000-3-2Class A	Home healthcare environment
Voltage fluctuations and flicker	IEC 61000-3-3Compliance	Home healthcare environment

Table 2 - Enclosure Port

Phenomenon	Basic EMC standard	Immunity test levelsHome Healthcare Environment
Electrostatic Discharge	IEC 61000-4-2	± 8 kV contact ± 2 kV, ± 4 kV, ± 8 kV, ± 15 kV air
Radiated RF EM field IEC 61000-4-3		10W/m80MHz-2.7GHz80% AM at 1kHz
Proximity fields from RF wireless communications equipment	IEC 61000-4-3 Refer to table 3
Rated power frequency magnetic fields	IEC 61000-4-8	30A/m50Hz or 60H

Table 3 – Proximity fields from RF wireless communications equipment

Test frequency (MHz)	Band (MHz)	Immunity test levels Professional healthcare facility environment
385 380-390 Pulse modulation 18Hz, 27V/m
450 430-470 FM, ±5k Hz deviation, 1kHz sine, 28V/m
710	704-787 Pulse modulation 217Hz, 9V/m745
780
810	800-960 Pulse modulation 18Hz, 28V/m870
930
1720	1700-1990 Pulse modulation 217Hz, 28V/m1845
1970
2450 2400-2570 Pulse modulation 217Hz, 28V/m
5240	5100-5800 Pulse modulation 217Hz, 9V/m5500
5785

El producto cumple con las siguientes normas: 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), IEC 60601-1-2:2014 / 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 essential 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

Producido por:

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

PROBLEMAS E SOLUÇÕES

ALARME TÉCNICO

O producto atende às segulentes normas: 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), IEC 60601-1-2:2014 / 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 essential 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)

Produzido par:

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

Das Produkt erfüllt die folgenden Standards: IEC 60601-1 Edition 3.1.2012-08 EN 60601-1:2006/41:2013 (Medical electrical equipment - Part 1: General requirements for basic safety and essential performance), IEC 60601-1-2:2014 / 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 60601-2-30:2018/EN IEC 60601-2-30:2019 (Medical electrical equipment - Part 2-30: Particular requirements for the basic safety and essential 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).

Hergesellt von: 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

Le produit répond aux normes suivantes: 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), IEC 60601-1-2:2014 / 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 essential 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).

Produit par:

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

Distribué par: Laica S.p.A.

To prošiv nákrpi tíc okloučes prošiovraφής: IEC 60601-1 Edition 3.1.2012-06 EN 60601-1:2006/A1:2013 (Medical electrical equipment - Part 1: General requirements for basic safety and essential performance), IEC 60601-1-2:2014 / 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 90601-2-30:2018/EN IEC 80601-2-30:2019 (Medical electrical equipment - Part 2-30: Particular requirements for the basic safety and essential 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)

Κοτασκευάζεται από: ANDON HEALTH CO., LTD. No. 3 Jinping Street, YaAn Road, Nankai District, Tianjin 300190, China.

HealthLabs Europe SAS - 36 Rue de Ponthieu, 75008, Paris, France

Produsul îndeplinește urmatoârele standarde: 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), IEC 60601-1:2:2014 / EN 60601-1:2:2015 (Medical electrical equipment - Part 1: 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 essential 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)

Produs de: 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

Tento produkt splňuje následující normy: 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), IEC 60601-1-2:2014 / 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 essential 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)

Vyrobce: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

Distributor: Laica S.p.A.

Izdelek izpolnjuje naslednje standarde: 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), IEC 60601-1-2:2014 / 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 essential 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)

Vyrobené: 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

Distribúcia: Lalca S.p.A.

A termék megfelel az alábbi szabványoknak: 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), IEC 60601-1-2.2014 / 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 essential 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)

Gyártotta: 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