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

Product type	Automatic blood pressure monitor
Brand	Laica
Model	BM2301
Measurement method	Oscillometric
Measurement range (pressure)	0 to 300 mmHg
Accuracy	+/-3 mmHg (pressure), +/-5% (heart rate)
Compatible arm circumference	22 to 36 cm
Memory	4 memory zones, 30 readings per zone
Arrhythmia detection	Yes, with visual indicator
Value classification	According to WHO scales
Display	LCD with date, time, pressure and pulse
Power supply	4 AA alkaline batteries (1.5 V)
Estimated battery life	About 2 months with 3 measurements per day
Operating conditions	Temperature: -10°C to +40°C, humidity: 15% to 90% RH
Storage conditions	Temperature: -20°C to +55°C, humidity: 15% to 90% RH
Maintenance	Clean with a soft, dry cloth; do not use abrasive products
Cuff cleaning	Wipe with a cloth dampened with ethyl alcohol (75-90%); do not machine wash
Safety	Do not immerse in water, do not disassemble, keep out of reach of children
Spare parts	Replacement cuff (22-36 cm); reference ABM008 for version 35-42 cm
Repairability	2-year warranty; do not open, contact after-sales service
Electromagnetic compatibility	Complies with EMC standards
Standards	Complies with the European Medical Devices Directive

Frequently Asked Questions - BM2301 LAICA

How to install the batteries?

Open the battery compartment by sliding the cover in the direction of the arrow. Insert 4 AA alkaline batteries respecting polarity, then close the cover.

How to set the date and time?

With the device off, press the SET button. Select the desired memory zone using the +/- buttons, confirm with SET. Set the year, month, day, hours and minutes with +/- and confirm each step with SET.

How to position the cuff correctly?

Slide the cuff onto the left arm, 1-2 cm above the elbow, palm facing up. The tube should be aligned with the arm. The cuff should be snug but not too tight (one finger should fit between the cuff and the arm).

What is the correct position for measuring blood pressure?

Sit with your back straight, feet flat on the floor, legs uncrossed. Place your arm on a table at heart level. Remain still and silent during the measurement.

What to do if the device displays an arrhythmia symbol?

The ♥ symbol indicates an irregular heartbeat. If the symbol appears frequently, repeat the measurement and consult a doctor.

How to view stored measurements?

Press and hold the - or + button to display the last memory zone. Use +/- to browse readings. Number 01 is the most recent, 30 the oldest.

How to delete stored data?

Turn off the device, select the memory zone with SET and +/-, then turn off. Hold + or - together with SET for 3 seconds until '....' is displayed to delete all data in that zone.

What does the 'Err' message on the screen mean?

The error may be due to low batteries, an incorrectly positioned cuff, or movement during measurement. Replace the batteries, check the cuff placement, or take another measurement at rest.

How to maintain the blood pressure monitor?

Clean the unit with a soft, dry cloth. Do not use abrasive products. The cuff can be cleaned with a cloth dampened with ethyl alcohol (75-90%) and air-dried. Do not machine wash.

Does the warranty cover batteries?

No, the warranty does not cover batteries or wear parts. The warranty is 2 years from delivery, in accordance with applicable law.

USER MANUAL BM2301 LAICA

Medical pressure monitor with digital display and black pressure monitor (no visible text or symbols)

ISTRUZIONI E GARANZIA

BM2301

MISURATORE DI PRESSIONE DA BRACCIO

page 5

INSTRUCTOR AND WARRANTY ANN OBLIGO PRESSURE MONITOR
Instrucción y gerencia MEDIDOR DE PRESIÓN PARA BRAZO página 25
Inclamações e guanças MEDIDOR DE PRESEÃO DE BRASCO pagina 35
D3 Anleistungen und Senelte Satz 45 ÜBERHÄN BLUTDRUCINESSDERÄT
F Inductione et garantie page 56 TEMENOMETRE À BRASSARD
OLIGUS MA CIVI YON CHEZOMETPO BPAXIONA
Instructur si garantie TENSIONETRU DE BRAT pagir a 75
Číslo Návod a zínuva TI LAKOMŠER NA PAŽI
BK Návezku zámou PAZNY TLAKOMER

BM2301

FIG.1 7 10 24 3 11 8

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124 Case

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EN 60801-1 Medical Electrical equipment part 1: General requirements for safety. EMC standard: EN 60801-1-2 Medical Electrical Equipment - Part 1-2. General Requirements For Basic Safety And Essential Performance - Collateral Standard: Electromagnetic Disturbances - Requirements And Tests

Performance standards: EC31060-2-30, Medical electrical equipment - Part 2.30. Particular requirements for the basic safety and essential performance of automated non-invasive syngomononutrients, EN 1060 3 Non-invasive sphygmatometers - Supplementary requirements for electromechanical blood pressure measuring systems, EN 1060 4 Non-invasive syngomononutrients. Test procedures to determine the overall system accuracy of automated non-invasive sphygmatomutrients. ISO 91060 2, non-invasive syngomononutrients - Part 2; clinical validation of automated measurement types

COMPATIBILITA' ELETTROMAGNETICA Tavola 1 - Per tuble in APPRECCHIATURE ME e LSISTEMI ME

Dear customer, Laica would live 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 wept for its entire life. If the appliance is transferred to another owner, its documentation must also be transferred in its ancestry. To ensure the safe and correct use of the product, the user must carefully read the instructions and warnings contained in the manual issue 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. - Vise del Lavoro, 10 - 36048 Barbarano Massaro (Mi Italy) Flurio +39 0442.765311 [e-mail] www.aica.i.

This completely automatic and non-invasive device measures and checks blood pressure (systolic and diastolic), the heart rate and checks for arrhythmics.

CONTENTS

KEY TO SYMBOLS

SAFETY WARNINGS CLASSIFICATION OF BLOOD PRESSURE READINGS

pag. 16

pag. 16 pag. 18

PRODUCT DESCRIPTION

INSTRUCTIONS FOR USE

MAINTENANCE

TROUBLESHOOTING

DISPOSAL PROCEDURE

WARRANTY

STANDARDS

ELECTROMAGNETIC COMPATIBILITY

pag. 18

psd. 19

pag. 21

pag. 21

KET TO SYMBOLS

Warnie Manufacturer

Prohibition

Launch Head the User

instructions care unit

Symbol for Type BF applied

pers" the cut is type III applied

per

- 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

Serial number

FARCO

Keep cral

(二)报告

European legislation on medical

SAFETY WARNINGS

1617

• 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 caro, protect it against accidental impact, extreme temperature fluctuations, humidity, dust, direct sunlight and sources of heat.
• In the event of a failure and/or manufurnor, turn off the device without temperature with a heat control or cooling system.
  Lampening with it. Always contact your retailer for rep • Ensure heads are on what we go the an and of key
  NEVER subreme the product in water or any other liquids

CAUTION! PRIOR TO USING THIS DEVICE

• This device can measure blood pressure in adults, 18 years and older (arm circumference from approx. 22 to 36 cm). To measure a child's blood pressure, consult your physician.

S. DO NOT use this device if you are suffering from severe arrythms. - Measuring your own blood pressure is a way of monitoring it and must no 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:

• parents with heart (13.5 mmHg)

• 1998: 01.11.19.25: Tearman (at Tymin),

- 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 antiovenous shunt (A-VI).
• when applying the device on a person that has had a mustelome.
• when using the blood pressure monitor at the same time as other medical monitor no devices already being used on the same limb.
• when undergoing dialysis treatment
• when taking anticoagulants, antiplatelets or steroids.
  In the following cases, the reading may be lower or imprecise: arteriocerosis, 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 interferances, see the paragraph "Electromagnetic compatibility information".
• Use only with the original manufacturer's cuff. Use of non-original cuffs may lead to new product packaging.
• 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 make 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.

LEATH IN ELECTRIC EARNINGS

English

Do NOT throw the batteries into an open flame.

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

- Keep betteries out of reach of children, the ingestion of patterns can cause

serious harm and death. If a battery is swallowed, state 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 or the list of the display indicate the classification of blood pressure readings.

BLOOD PRESSURE CLASSIFICATION	SYSTOLIC (mmHg)	DIASTOLIC (mmHg)	SEGMENT COLOR
OPT MAX	≤ 150	<60 ≤ 8 mm
Normal	120 - 170	60 - 84 g/cm
Normal - High 130 - 189 Kg/- 189 Green
minutes on 1st grade - Low: 140 - 159 kg- 59 Yellow
minutes on 2nd grade - Moderate: 190 - 179 kg- 1.0g
minutes on 3rd grade - Single	≥ 150	≥ 10	Tea

Values below 105 mmHg (systolic) and 80 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:	"DI" Key
3:	"Set" Key
4:	"+' Key
5:	"*" Key
6:	Plug tube
7:	Amband
8:	Air connectio
9:	Air tube
10:	Batteries
11:	Battery corn
12:	Case

TECHNICAL SPECIFICATIONS

• Product name: Blood pressure monitor

• Commercial name: EM2501

- Classification: Internally powered, Type EF applied part, IP20

- Method: ocellometro, automatic air inflation and measurement

- Measurement range: from 0 to 300 mmHg (call pressure),

from 30 to 180

• Precision: systolic, clasmodin +3 mmHg

Mean rate ±5%

• Memones: 30 memores per area (4 areas)

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English EN

• Arm circumference: between approx. 220 and 360 mm

• Power supply: 4 x 1.5V AA alkaline batteries (LAC6)

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

• Environmental conditions for use from +10°C to +40°C; relative humidity

15%\~90% H

• Environmental conditions for storage: from -20°C to +55°C; relative humidity

15%-90% RH

• The bico pressure monitor has been designed to maintain its performance

and safety characteristics for approx 5 years at 10 test per day

INSTRUCTIONS FOR USE

BATTERY INSERTION/REPLACEMENT

This blood pressure monitor works with 4 disposable 1.5W AM alkaline batteries. At first, use, iner, the batteries.

Open the battery compartment sliding the cover in the arrow direction, then

insert the batteries according to the indicated poles and close the cover.

When the paper shows the battery symbol (X), in the case ends 4 shn

acoustic signals and dusts for that one air land, it is necessary to replace the bettering lines that are flat.

Dispose of warm batteries as described in the "Disposal procedure" paragraph

DATE/TIME SETTING

1) With off device, press the "SET" key; the last selected memory area is

3.4 blinks on the display. To select the desired memory area, press the

keys " + " and confirm the selection pressing the "SET" key.

Now, the number related to the month binks on the display. Use the keys

and - to adjust this value by keeping them dressed, the scrating of

the numbers becomes faster.

Press the SL-407 to confirm it.

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

format

Adjust the data using the "+" and "-" keys are confirm using the "SET" key.

1. Then, turn off the device pressing the "O" key. When batteries are inserted

or replaced. It is necessary to set the data and time once again.

WRAPPING THE CUFF

1) Doen 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 vetro wrap.

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

huse at the centre of the cull.

The butt should it snugly around the arm but should not be pulled too lightly.

leave enough room to insert a finger between the cuff and arm. If the cuff is

too light or too cause. the readings will be inaccurate.

Never roll sleeves up or the blood flow will be obstructed and the reading will

not be accurate.

A Make sure that the supplied cuff (22 - 36 cm) corresponds to the arm

circumference A cull with circumference 30 - 42 cm is available: spare

part code:ABMDCB

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 jewelry from the arm and wrist before applying the

cull

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

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

Rest the arm on a hard surface so that the curl 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.

English

5) Rest both feet on the floor without crossing overs at feet.

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

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

7) Do not rely on a single reading. We recommend taking at least two readings at least 10/15 minutes apart.

It is important to rest the arm during this time as blood congestion may result in false readings.

8) If unpleasant sensations are experienced during a reading, immediately from the device off using the "Oil" button.

TAKING A READING

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

2) Keep the "U" key pressed until you hear an acoustic signal. On the display, all function symbols switch on, just for two seconds. The symbol indicates that the device is ready for the measurement. If there is still an in-the-cut from the previous reading, the symbol will flash on the display for a few seconds.

3) The cuff will automatically inflate and will stop when it reaches the right level. Try to stay relaxed, will out speaking at moving.

If the preset pressure (90 mmHg) is considered insufficient or it a hard movement is made, the device will start inflation over again (until a maximum of 250 gm)

4) The curl will automatically inflate and the display will show the systatic and diastatic pressure, heart rate, date and time of the reading.

The (■) symbol appears only in the event of an irregular heartbeat (anhydral). The segments on the left of the display indicate the classification of blood pressure (pacitus).

a) The device will turn off automatically after about 3 minutes or non-use. Otherwise, it can be turned off by pressing the "O/I" key. The reading can be

interrupted by pressing the "C/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 3D readings in each memory area (4 memory areas). After every reading, all values are automatically stored.

To call up the measurements stored in the last selected memory area, it is necessary to keep one of the keys. '+' or '-' pressed; the display shows the symbol. '+', '+', '+', or '+'. To scroll the stored data, press the key '+' or '-' and the following will appear in sequence.

- The increase number, on the right box one correct of the display.

• the stored values.

- 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 "Oel" key.

After 30 readings, the oldest data will be automatically deleted.

I there are no stored readings, the display will show "O SYS 0 DIA"

To call up the own memory area, it different from the last one selected before the last measurement. It is necessary to press the key SET and select the desired memory area pressing the keys '+' and '-''; then, turn off the device by pressing the '04' key.

Finally, it is possible to display the average values of the last 3 measurements performed. With off device, press the "-" key and keep it pressed until the device units an acoustic signal.

The display shows the message "WG" indicating the average of the last 3

2021

English EN

measurements performed.

Attention: If there are 3 measurements for the memory area selected, it will not be possible to view the measurement average. In this case, the display will show the last measurement taken.

DELETING THE STORED DATA

Delating all data stored in a memory area.

With all device, call up the own memory area by pressing the "SET" key and then the keys "+" and "-"; then, turn off the device by pressing the "OUT" key, four, keep the key "+" or "-" pressed and then press the "SET" key for about 3 seconds, the device emits a short acoustic signal and the display shows -". Four all data related to the previously selected memory area have been deleted. To delete the data for another memory area, repeat the operation above, recalling the memory area involved.

MAINTENANCE

- Store the device in its case in a well ventilated and dry place without wrapping the hose too lightly and without settling any heavy objects on top of

- Clean the blood pressure monitor using a soft cloth, either dry or moistened

with water and a liquid disinfectant

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

• Make sure thumbs are never pulled into the air nose.

Do not press the "Cyl" key if the cull is not wrapped around the arm.

- DO NOT decrease the desire - It is recommended the performance should be checked every 2 years. Please contact the service Laca (this is not included in warranty).

TROUBLESHOOTING

Problem Possible cause Solution
After pressing the CIV 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 electromagnating interference.	Remove the batteries for a series and have the reading again.
The display shows the dead artery button (CK)	The batteries are worn. If worn, the two main batteries are used, they all need to be replaced more often.	Replace them. Use alkaline batteries to increase operating acotomy.
The readings are very low or very high	The cuff is not correctly positioned.	Read the "Wragging the cuff" paragraph.
	Incorrect posture while taking the reading.	Read the "Prunor reading method" paragraph.
	During the reading, the person took a movement or spread, or the reading was taken at a time when the person was particularly anxious or passive.
The heart rate readings are too low or too high.	A woman was made during the reading.	Read the "Prunor reading method" paragraph.

English English

Problem Possible cause Solution
The head rate readings are too low of the high.	The reading was taken after exercise.	Re-read the "Proper reading method" paragraph.
The (♥) symbol appears on the decay.	An irregular heartloss was collected (orophily).	Repeat the reading. If the symbol appears again, seek medical advice.
The display code "En".	The head pressure monitor was able to read the symbolic or distalistic pressure.	Do not move during readings
	The cut pressure has exceeded 300 mmHg.	Wait 5 minutes, then take the reading again. If the decay shows this error again contact customer service.

DISPOSAL PROCEDURE

The symbol on the bottom of the device indicates the separated collection of electric and electronic equipment (Dir. 2012/19/Eu-WEEE).

At the end of life of the device, do not dispose it as mixed solid municipal waste, but dispose it referring to a specific collection centre located in your area or returning it to the distributor, when buying a new device of the same type to be used with the same functions.

If the appliance to be disposed of is less than 25 cm, it can be returned to a retail

location that is over 400 m² without having to purchase a new, similar device. This procedure of separated collection of electric and electronic devices is carried out forecasting a European environmental policy aiming at safeguarding, protecting and improving environment quality, as well as avoiding potential effects on human health due to the presence of hazardous substances in such equipment or to an improper use of the same or of parts of the same. Duration: 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 pores, or another longer farm encasaged by the national legislator of the consumer's residence. This provisions comply 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 definitely 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 ended 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].

for payment will be due for repairs or replacements of products that fail within the terms of the warranty. In the event of faults, contact the retailer. Do NOT send the appliance directly to LAICA. All the associations 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. This manufacturer declines any liability for any damage that may, directly or indirectly, he caused to persons, property or animals as a result of the non-observance of all the requirements established in his relevant instructions manual and concerning. The company is responsible for obtaining the maintenance of LAICA, in its constant commitment to improving its products, is enough to charging without any notice, in whole or in part, its products in relation to production requirements, without this stealing any liability for Laica towards its dealers. For further information: www.lakua.it

STANDARDS

This device complies with European standards and meets the following major standards (including but not limited to): EN 60801-1 Medical electrical equipment part 1: General requirements for safety. EMC standard: EN 60801 1 2 Medical Electrical Equipment Part 1 2: General Requirements For Basic Safety And Essential Performance -- Collateral

Standard: Electromagnetic Disturbances - Requirements And Tests. Performance standards: IEC81060-2-30. Medical electrical equipment - Part 2-30: Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers, ISO 11060-3. Non-invasive sphygmomanometers - Supplementary requirements for electromechanical fluid pressure measuring systems, ISO 11060-4 non-invasive sphygmomanometers - Test procedures to determine the overall system accuracy of automated non-invasive sphygmomanometers, ISO 81060-2, non-invasive sphygmomanometers - part 2: clinical validation of automated measurement type.

ELECTRONAGNETIC COMPATIBILITY
Table 1 - For all ME EQUIPMENT and ME SYSTEMS

Guidance and manufacturer's declaration - electromagnetic emissions
The DCVDC is recorded for use in the electromagnetic environment prescribed below. The customer or the user of the DCVDC should assure and did not be used in such an environment.
Emissions test Compliance Electromagnetic environment – guidance
R emissions, CEPR-11	Class 1	The EVDC uses R energy only for the human laborer. Therefore, R emissions are very low and rare but likely to cause any emissions in activity, electronic environment.
R' emissions, CEPR-11	Class B
Personal emissions class IEC-01-003-2-2	I/3	The DCVDC is a choice for use in all establishments, including the commercial retail business and their specific companies. In this part, the whole power supply restricted from supplies, shall go used for domestic prices.
Wireless (manual) and (moderate) emissions IEC-01-003-3-3	I/3

Table 2 · For all ME EQUIPMENT and ME SYSTEMS

Guidance and manufacturer's declaration - electromagnetic immunity
The DCATC is intended for use in the electromagnetic environment specified below. The routine or the user of the DCATC should issue that it, as well, is much an environment.
Immunity test	IEC 60021 test level	Compliance level	Electromagnetic environment - guidance
Dechlorated discharge (SSN) EC 8100-4-2	= 9 km contact + 5 km air	= 8 km contact + 10 km air	Has a device for work, account or contract. We do follow us are carried with pipeline material. The relative humidity should be at least 30 %.
Power frequency (DCATC) is intended to be EC 8100-4-5	2 Arm 5 Arm		Power frequency magnetic field should be at levels of current and of capital location on a typical commercial or hospital environment.

2425

Table 3 - For ME EQUIPMENT and ME SYSTEMS that are not LIFE-SUPPORTING

Guidance and manufacturer's declaration - electromagnetic immunity
The ECOVIE is monitored to use in the electromagnetic environment specified below. The capacitor of the user of the ECOVIE should be taken off its speed in each one environment.
Immune test	IEC 60601 test level	Compliance level	Electromagnetic environment – guidance
			For example, multiple RF communication systems (direct directly then used as close to any one of the ECOVIE, including other, the remote communication system) on the distance calculated from the exclusion of the direct proximity of the transmission.
Combined RF IEC 61000-4-3	3 V/m2(3 V/m2 to 8 V/MeV)	N/A	Recommended separation distance: d = 1.2 to 0.5 to 1.5 to d = 2.3 to 0.7 to 0.5 where d is the main output power rating of the transmission with E , according to the current for manufacturer and the remote communication proportion of data to the number of.
Kochstrom RF IEC 61000-4-3	3 V/m2(5 V/MeV to 2 V/MeV)	0.5

Table 4 - For ME EQUIPMENT and ME SYSTEMS that are not LIFE-SUPPORTING

Recommended separation distances between portable and mobile RFcommunications equipment and the DEVICE
Rated maximum output power of transmission U	Separation distance according to frequency of transmitter m
	100 kHz to 80 MHz d = 1.2	50 MHz to 600 MHz d = 1.2	800 MHz to 2.6 GHz d = 2.3
0.01-0.12-0.22
0.12-0.38-0.49
1.12-1.22-1.23
1.32-1.58-1.76
1.90-2.16-2.29

Español Español

Symbols are 4th DF series

↑

STUDCH "IDOS" DANS

X

m = 311

[Unreadable]

Marlere 9012

↓

[Unreadable]

C€0425

• 1000000, 30 (400000) [in: 2000 (400000)]

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Español

EN 60631-1 Medical electrical equipment part 1. General requirements for safety.

EMC standard: EN 60601-1-2 Medical Electrical Equipment - Part 1-2. General Requirements For Basic Safety And Essential Performance - Collateral Standard: Electromagnetic Disturbences - Requirements And Tests.

Performance standards: IEC81060 2-30, Medical electrical equipment - Part 2-50; Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers. EN 1360-3, non-invasive sphygmomanometers - Supplementary requirements for electromechanical blood pressure measuring systems. EN 1060-4 Non-invasive sphygmomanometers - Test procedures to determine the overall system accuracy of automated non-invasive sphygmomanometers. ISO 81060-2, non-invasive sphygmomanometers - part 2 clinical validation of automated measurement type.

© HAC law or other law

© 1945. Poul se prise his locé.

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31 TBCB SET

41 T2k+

5) Tsc1a

5.1.2014

7.

PROBLEMAS E SOLUÇÕES

Late depositiva encaixa-se em contamidade com as normas europeas e satatas as principal resfas ações aguntados incluindo, mas não limitado: EN 08001-1 Medical electric equipment part 1: General requirements for safety. EMC standard: EN 08001 1 2 Medical Electrical Equipment Part 1.2 Genera Requirements for basic Safety And Essential Performance - Colateral Standard Electromagnetic Disturbances - Requirements And Tests. Performance standards: ECB1080 2-30, Medical electrical equipment Part 2.30. Particular requirements for the basic safety and essential performance of automated non-invasive sangugmomanometers, EN 1080-

1. Non-invasive sphygmomanometers - Supplementary requirements for electrochemical blood pressure measuring systems. EN 1060-4 non-invasive sphygmomanometers - Test procedures to determine the general system accuracy of automated non-invasive sphygmomanometers, ISO 81060 2, non-invasive sphygmomanometers - part 2: clinical validation or automated measurement type.

2.14. The following table is a duplicate of the previous table to be corrected.

COMPATIBILIDADE ELETROMAGNÉTICA
MESS 1 - Para todos os APARELHUS ME o SISTENAS ME

© Nettel Balle, 1904, and a Italian (Balle et al.

EVC standard: 5v 0001-1 2 Medio Electrical Equipment - Par. 1: 2: General Requirements for basic safety And Essential Performance - Collateral Standard Electromagnetic Disturbances - Requirements And Tests.

Performance standards: IC851300-2-90, Medical electrical equipment - Par. 2: 30: Particular requirements for the basic safety and essential performance of automated non-invasive sphingometer-meters. By 1060-3 Non-invasive

sphingometerometers - Supplementary requirements for electromechanical blood pressure measuring systems, EN 1060-4 Non-invasive sphingometerometers - Test procedures to determine the overall system accuracy of automated non-invasive sphingometerometers ISO 91000 2, nor invasive sphingometerometers (out 2): clinical validation of automated measurement type.

• 2016. The company, the company of the company

- 2013.10.15

To the course, we have to be a new

High-occurring air supply and/or other equipment, non-renewable air supply or repositioned to electrical equipment (the main air supply/gasoline solid oxide sensor lab); EN 608H-1 Medical Electrical equipment part 1: General requirements for safety. ENC standards; EN 606C-1.2 Medical Electronics Equipment - Part 1: 2-Generi Requirements For Basic Safety And Essential Performance - Collateral Standard of Electrical Equipment. Part 2: 2-Technical specifications for the basic safety and essential performance of mechanical components. Performance standards: EC(8190-6-20). Minimal access equipment - Part 2-30. Particular requirements for the basic safety and essential performance of automated non-invasive spraygmannometers. EN 100.3 Non-invasive spraygmannometers Supplementary requirements for a electrode area blood pressure measuring systems, EN 100.4 Non-invasive spraygmannometers Test procedures to determine the overall safety recognition of automated non-invasive spraygmannometers, EC(8190-6-20). Part 2 clinical validation of automatic measurement type.

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Standard: Electromagnetic Disturbances - Requirements And Tests. Performance standards: ISO81060-2-50. Medical electrical equipment - Part 2-30: Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers, EN 1060-3 Non-invasive sphygmomanometers - Supplementary requirements for electromechanical blood pressure measuring systems, EN 1060-4 Non-invasive sphygmomanometers - Test procedures to determine the overall system accuracy of automated non-invasive sphygmomanometers, ISO 81060-2, non-invasive sphygmomanometers - part 2: clinical validation of automated measurement type.

COMPATIBILITATE ELECTROMAGNETICA
Piança 1 - Pencru toate ECHIPAMENTELE ME ŞI SISTEMELE ME

Tento plazo odpovidá evopayxim predpisím a následújícím havním normán (zabnuto, ale nozomizón): EN 0602/1: Medical electrical equipment part 1: General requirements for test.
EMO Standard: EN 0609/1-2: Medical Electrical Equipment - Part 1-2: General Requirements For Basic Safety And Essential Performance - Collateral Standard: Electromagnetic Disturbances - Requirements And Tests.
Performance standards: IEC81060-2-30, Medical electrical equipment part 2: Partial requirements for basic safety and essential performance of automated non-invasive sphygmomanometers, EN 1050-3: Non-invasive sphygmomanometers - Supplementary requirements for electrochemical blood pressure measuring systems, EN 1060-4: Non-invasive sphygmomanometers - Test procedures to determine the overall system accuracy of automated non-invasive sphygmomanometers. EN 81060-3: Non-invasive sphygmomanometers - part 2: clinical validation of automated measurement type.

ELEKTROMAGNETICKÁ KOMPATIBILITA Tabulka 1 - Pro vsechna ZARIZENI ME a SYSTEMY ME

Tento pristrojo je v solade s urodyskyni normami a spifa lielo tivane standardy (vatano, ale no vylúčne) EN 06901-1 Medical optical equipment part 1: General requirements for safety. EMO standard: EMO-10603-2-30. Medical Optical Equipment and General Requirements For Bagn Safety And Professional Performance - Collateral Standard; Electromagnetic Disturbances - Requirements And Tests. Performance standards: IEC81060-2-30. Medical optical equipment Part 2: 30. Particular requirements for the general safety and essential conditions. EMO-10603-2-30. EMO-10603-2-30. EMO-10603-2-30. EMO-10603-2-30. EMO-10603-2-30. EMO-10603-2-30. EMO-10603-2-30. EMO-10603-2-30.

ELEKTROMAGNETICKA KOMPATIBILITA
Tuborka 1 - Proviský Pristroje MEJ SYSTEMY ME