WBPM-100 - Blood pressure monitor LANAFORM - Free user manual and instructions

USER MANUAL WBPM-100 LANAFORM

The photographs and other images of the product in this manual and on the packaging are as accurate as possible, but do not claim to be a perfect reproduction of the product.

Thank you for choosing the LANAFORM WBPM-100 wrist blood pressure monitor. The wrist blood pressure monitor is designed to be a non-invasive measuring process and for monitoring adults' blood pressure. It allows you to measure your blood pressure quickly and easily, register the values and display changes in values. It warns you if you have an irregular heart beat.

TITLE AND DESCRIPTION OF DISPLAY SYMBOLS ON THE INSERT DESCRIBING THE PRODUCT'S FEATURES

Definition of the symbol	Identification	Information provided by the manufacturer
Manufacturer's details		Manufacturer
Batch number	LOT	Production batch number
BF device		The cuff is type BF applied part
Instructions for use		Follow the instructions for use The sign background colour: blue. The sign graphical symbol: white
Please note: see instructions for use		Please note: consult the enclosed documents. Please read these instructions before using the device. Please also follow these instructions carefully when using the device.
Notified body	€ 0197
European representative	ECREP	European representative
Electrical and electronic waste (WEEE)		The device should not be disposed of with other household waste at the end of its serviceable life.
Date of manufacture
Serial Number	SN
	IP22 The first characteristic numeral symbol for "Degrees of protection against access to haz-ardous parts and against solid foreign objects".The second characteristic numeral symbol for "Degrees of protection against ingress of water"

▲ PLEASE READ ALL THE INSTRUCTIONS BEFORE USING YOUR BLOOD-PRESSURE MONITOR, PARTICULARLY THESE FEW BASIC SAFETY INSTRUCTIONS

• When using this product, please make sure you comply with all the items listed below. Any deviation from these instructions may cause injury or affect the accuracy of the readings.
  Always measure your blood pressure at the same time of day so that the values are comparable.
• Rest for about 5 minutes before taking any measurements.
• When you have to take several measurements on an individual, wait for 5 minutes between each measurement.
• Do not eat, drink, smoke or take part in physical activities for at least 30 minutes beforehand.
• Refrain from talking when the monitor is recording measurements in order to guarantee their accuracy.
  Take another measurement if you are at all in doubt about the values you have been measuring.
  The measurements you have taken are purely for information purposes—they are not a sub stitute for a proper medical examination!
• Notify your doctor of your results since you should never under any circumstances take any medical decisions based on these measurements alone (for example, choosing medicines and their dosages).
• Do not use the blood-pressure monitor on new-borns, pregnant women and patients with pre-eclampsia.
  It is inappropriate for people with serious arrhythmia to use this Electronic Sphygmomanometer.
• Do not use the cuff other than supplied by the manufacturer, otherwise it may bring biocompatible hazard and might result in measurement error.
  If the blood circulation is restricted in an arm due to chronic or severe vascular diseases (including vasoconstriction), the accuracy of the measuring process on the wrist is limited. In this case, use an upper arm blood pressure monitor.
  Cardio-vascular disease can cause incorrect or inaccurate measurements. This is also true for very low blood pressure, diabetes, circulation problems, irregular heartbeats and chills, fever or shaking.

The monitor must not be used at the same time as any high-frequency surgical device.
Only use the device on people whose wrist perimeter is the same as that stated for the device.
Please note that the function of the limb concerned may be hampered when inflating.
Blood circulation must not be blocked for longer than necessary when taking blood pressure. If the device does not work, remove the cuff from the arm.
- Do not take measurements too frequently and avoid sustained pressure in the cuff. This causes blood circulation to be reduced and may cause injury.
- Please do not put the cuff on an arm, the arteries or veins of which are undergoing medical treatment, e.g. where an intravascular access device is present which is intended for intra-vascular treatment or if there is an arteriovenous shunt in place.
- Do not use the cuff on people who have undergone a mastectomy.
- Do not put the cuff over wounds as its use may aggravate them.
- Put the cuff only round the wrist. Do not put the cuff over other parts of the body.
The blood-pressure monitor is battery-operated only.
Automatic switch-off means that the monitor will go into energy-saving mode when left untouched for one minute.
The device is designed for use as described in these instructions for use. The manufac turer cannot be held responsible for damage caused by inappropriate or improper use.
- Do not use the cuff other than supplied by the manufacturer, otherwise it may bring biocompatible hazard and might result in measurement error.
- Please do not share the cuff with other infective person to avoid cross-infection.
- Avoid compression or restriction of the connection tubing during measurement, which may cause inflation error, or harmful injury due to continuous cuff pressure.
- This Electronic Sphygmomanometer is designed for adults and should never be used on infants or young children. Consult your physician or other health care professionals before use on older children.

Storage and maintenance instructions

• The monitor is made up of precision electronic components. The accuracy of the values measured and the serviceable life of the device depend on careful handling:
• Protect the device from shocks, humidity, dirt, marked fluctuations in temperature and direct sunlight.
• Do not drop the device.
• Do not use the device in the vicinity of strong electro-magnetic fields and keep it away from cordless or portable telephone facilities, etc.
• It is recommended that the batteries be removed when the device is not being used for long periods.

Notes on batteries

If the liquid of the battery cell comes into contact with the skin or eyes, rinse the area affected with water and consult a doctor.

Ingestion hazard! Young children might swallow the batteries and suffocate. So keep the batteries out of the reach of children!
- Check the plus (+) et minus (-) polarity symbols.
- If a battery has leaked, put on protective gloves and clean the battery compartment with a dry cloth.
- Protect the batteries from excessive heat.

Explosion hazard! Do not throw batteries onto the fire.

• Do not attempt to re-charge the batteries.
• Remove the batteries from the battery compartment if the device is not to be used for a lengthy period.
• Use only identical or equivalent batteries.
  Always replace all the batteries at the same time.
• Do not use rechargeable batteries.
• Do not dismantle, open or break the batteries.

Instructions for repair and removal

• Batteries must not be disposed of with household waste.
• Please take flat batteries to the collection points provided for this purpose.
• Do not open the device. Failure to follow these instructions may void the warranty.
• You must not repair or adjust the device your self. If you have done so, safe operation of the device can no longer be guaranteed.
  Only the customer service department or an authorised operator may carry out any repairs.
• Before filing any claim, however, please check the battery status beforehand and replace them, if necessary.
• In the interests of environmental protection, the device should not be disposed of with other household waste at the end of its serviceable life. It should be disposed of via your country's authorised collection points. The device must be disposed of in accordance with the European WEEE (Waste Electrical and Electronic equipment) Directive on used electrical and electronic devices. If you have any questions on this, please contact the local bodies responsible for the disposal and recycling of these products.

DESCRIPTION OF THE DEVICE

1 Screen
2 STOP/START button
3 Memory button

4 Wrist cuff
5 Battery compartment
6 Scale for ranking measuring results

DISPLAY SCREEN

7 Systolic pressure
8 Diastolic pressure
9 Pulse rate measurement
10 Pulse symbol
11 User memory
12 Backup location number/average memory value (AL), morning (A), evening (P)
13 Memory function symbol
14 Irregular heart beat symbol
15 Ranking measuring results
16 Deflation
17 Time et date
18 Battery change symbol

INSERTING THE BATTERIES

• Remove the battery compartment cover (5) on the left-hand side of the device.
• Insert two 1.5V micro batteries (LR03 alkaline not included in the packaging).
• You must insert the batteries according to the polarity illustrated. Do not use rechargeable batteries.
• Close the battery compartment cover carefully.
  If the battery change symbol (18) appears, no measurements can be taken and you need to change all the batteries.

Removing the batteries

• Flat and fully discharged batteries must be disposed of in special containers or at collection points intended for this purpose or returned to an electrical appliance retailer. You have a legal obligation to dispose of batteries properly.

SET-UP DATE AND TIME

• This menu allows you to adjust the following functions one after the other: Time Date Format
  You must adjust the date and time. Without these adjustments, it is impossible to register and read your measurements accurately with the date and time.

Time format

• Press and hold down the STOP/START button (2) and the memory button (3) at the same time for 3 seconds or insert the batteries.
  Using the memory button (3), select the time format you require and confirm by pressing the STOP/START button (2).

Date

The year flashes on the screen. Using the memory button (3), select the year you require and confirm by pressing the STOP/START button (2).

The month flashes on the screen. Using the memory button (3), select the month you require and confirm by pressing the STOP/START button (2).
The day flashes on the screen. Using the memory button (3), select the day you require and confirm by pressing the STOP/START button (2).

If the time format has been adjusted to 12pm the order of the day and month displayed is reversed.

Time

0:00

• The time flashes on the screen. Using the memory button (3), select the time you require and confirm by pressing the STOP/START button (2).

0:00

• The minutes flash on the screen. Using the memory button (3), select the minutes you require and confirm by pressing STOP/START (2).
• Once all the dates have been adjusted, the device automatically switches off.

MEASURING BLOOD PRESSURE

Positioning the cuff

• Blood pressure may be different between the right and left arm and the blood pressure values may therefore also be different. Always take the measurement on the same arm.
• If the values between the two arms are very different, you must decide with your doctor which arm to use for the measuring process.
  Make sure your left wrist is bare. Make sure that your blood circulation is not restrictive by clothes that are too tight or anything else. Put the cuff on the inside your wrist.
• Close the cuff with the Velcro fastening so that the upper edge of the device is approximately 1.2cm from the palm of your hand.
• The cuff must be wrapped tightly around the wrist without strangling it.

Adjusting to the correct position

Rest for about 5 minutes before taking any measurements. Otherwise, this may cause errors.
Measurements must only be taken when sitting down or prone. Make yourself comfortable before taking your blood pressure. Make sure that your back and your arms are well supported on the backrest and armrests. Do not cross your legs. Put your feet flat on the floor. You must support your arm and fold it. Make sure in every case that the cuff is at heart level. Otherwise, this may cause substantial errors. Relax your arm and palms.
In order not to distort the result, it is important to remain calm when taking the measurements and not to talk.

Measuring blood pressure

Position the cuff as described above and get into the position you want to take the measurements.
To start the monitor, press the STOP/START button (2). All displays will light up briefly.

To choose the memory location you want, press the memory function button (3) (4)
The results of measuring 4 different people or the morning and evening measurements may be recorded separately in four memories with 30 places.
The monitor automatically starts the measuring process.
You can stop the measuring process at any time by pressing the STOP/START button (2). As soon as it recognises a pulse, the Pulse symbol is displayed.

The results of measuring the systolic pressure (7), diastolic pressure (8) and the pulse (9) are displayed. The irregular heartbeat symbol (if there is one) (14) and the symbol for ranking the measuring results (15) flash.
- Er_ is displayed when the measuring process has not been carried out correctly. Read the chapter Error message/Rectifying errors in these instructions for use and start taking measurements again.
- Switch off the monitor by pressing the STOP/START button (2). The measuring result is then recorded in the user memory you have chosen.
If you forget to switch off the device, it will switch off automatically after approximately 1 minute.
Wait at least 5 minutes before taking another measurement.

EVALUATING THE RESULTS

Irregular heart beat

This device is able to identify any irregular heart beat during the measuring process and displays it, if necessary, after the measuring process with the corresponding symbol (14).
- This may indicate arrhythmia. Arrhythmia is a disease characterised by an anomaly in the heart rate due to disturbances in the bio-electrical system. The symptoms (heart beats that are late or early, faster or slower pulse) can be caused particularly by heart disease, by age, by natural predisposition, by a diet that is too rich, by stress or even by lack of sleep. Only a medical consultation can determine arrhythmia. If the symbol is displayed after the measuring process, start again. Make sure that you rest

for 5 minutes and do not talk or move during the measuring process. If the symbol often appears, please consult a doctor. Self-diagnosis and self-medication based on the results of the measuring process can be dangerous. You must follow your doctor's instructions.

Ranking measuring results

The result of the measurement process are ranked and evaluated according to the table below.

These values must only be used for information purposes because blood pressure differs from person to person and depending on their age, etc. It is important to consult your doctor regularly.

Your doctor will provide you with your own values for normal blood pressure and the level at which blood pressure is regarded as dangerous.

The ranking is displayed as is the scale of the device for establishing the range within which blood pressure has been measured. If the systolic and diastolic values are within two different ranges (e.g. systolic within the "normal high" range and diastolic within the "normal" range), the scale markings for the chart will always give the highest range on the device, i.e. "normal high" in this example.

Range of blood pressure values	Systolic (in mmHg)	Diastolic (in mmHg)	Colour displayed
Level 3: acute hypertension	≥ 180 ≥ 110 Red
Level 2: intermediate hypertension	160 – 179 100 - 109 Orange
Level 1: mild hypertension	140-159 90 - 99 Yellow
Normal high	130 - 139	85 - 89	Green
Normal	120 - 129	80 - 84	Green
Optimum	<120	<80	Green

Source: WHO, 1999 (World Health Organisation)

Recovering and removing measuring values

The result of every successful measurement is recorded with the date and time. When there are more than 30 measuring data, the oldest measurement is deleted.
- Press the memory button (3) to display the measuring result. The number of results recorded for the selected user is displayed.

• Press the STOP/START button (2) to select another user and confirm by pressing the memory button (3).
  The average value (AL) (12) of all the values measured and recorded for this user is then displayed.

If there is no result in the memory of the selected user, the LCD screen displays "0" for blood pressure and for the pulse measurement.

EN FR NL DE SL SV

• Press the memory button (3). A7 flashes on the screen. The average value of morning measurements of the last 7 days is displayed (morning: 5am - 9am ).

• Press the memory button (3). P7 flashes on the screen. The average value of evening measurements of the last 7 days is displayed (evening: 6 pm 8 pm).

If you press the memory button (3) again, the latest measurement is displayed on the screen. The irregular heartbeat symbol (if there is one) (14) and the symbol for ranking the measuring results (15) flash.

If you press the memory button (3) again, you can see your individual measurements.
To switch the device off, press the STOP/START button (2).
- You can leave the menu at any time by pressing the STOP/START button (2).

Deleting the values measured

To delete the records of a specific user memory, first select a user memory.
- Hold the memory button (3) down for 3 seconds to delete the results.

ERRORMESSAGE/ RECTIFYING ERRORS

Problem Cause Solution

The LCD screen displays an abnormal result.	The cuff is in the wrong position or has not been tightened sufficiently.	Apply the cuff correctly and try again.
	The body's posture is not correct during the test	Re-read sections "Adjusting to the correct position" in the instructions and try again.
	Arm or body movement, nervousness, excitement or the act of talking during the measuring process	Take another measurement and follow the positioning instructions and instructions for use.
	Hear t rate is irregular (arrhythmia)	The blood pressure monitor is not suitable for people suffering from serious arrhythmia

In the event of error, an error message is displayed on the screen Er_.
- Error messages may be displayed when:
the systolic or diastolic pressure has not been measured (ER1 or ER2 is displayed on the screen);
systolic or diastolic pressure is outside the measuring range ("Hi" or "Lo" is displayed on the screen);
the cuff is too tight or too loose (ER3 or ER4 is displayed on the screen);
blood pressure is higher than 300mmHg (ER5 is displayed on the screen);
inflation takes more than 180 seconds (ER6 is displayed on the screen);
there is an error on the system or the device (ER7 or ER8 or ERA is displayed on the screen);
the batteries are nearly flat (18).

Technical alarm - Description

If the (systolic or diastolic) blood pressure taken is outside the range indicated in the "Technical Features" paragraph, the technical alarm displays the message "Hi" or "Lo" on the screen. In this case, consult a doctor or check that you are using the device properly. The technical alarm's limit values are values set by the factory and can neither be changed nor deactivated. Under the IEC 60601-1-8, these limit values of the alarm have a lower priority. The technical alarm is not a locked alarm and does not need to be reset. The signal displayed on the screen switches off automatically after approximately 8 seconds.

MAINTENANCE AND STORAGE

Clean the device and the cuff carefully, using only a slightly damp cloth.
- Do not use detergent or solvent.
- Never put either the device or the cuff in water as this might seep into the device or cuff and damage them.
- Do not put heavy objects on the device or on the cuff when they are being stored. Remove the batteries.
- No component can be maintained by user in the monitor. The circuit diagrams, component part lists, descriptions, calibration instructions, or other information which will assist the user's appropriately qualified technical personnel to repair those parts of equipment which are designated repairably can be supplied.
- It is recommended the performance should be checked every 2 years or after repair. Please contact the service center.
The monitor can maintain the safety and performance characteristics for a minimum of 10,000 measurements or three years.
The cuff integrity is maintained after 1,000 open—close cycles of the closure.
It is recommended the cuff should be disinfected 2 times every week if needed (For example, in hospital or in clinique). Wipe the inner side (the

side contacts skin) of the cuff by a soft cloth squeezed after moistened with Ethyl alcohol (75 - 90%) , then dry the cuff by airing.
Clean the cuff after the usage of every 200 times is recommended.

TECHNICAL SPECIFICATIONS OF THE PRODUCT

Model number LA090205

Measuring method	Measuring blood pressure on the wrist, oscillometric and non-invasive
Measuring range	Pressure in the cuff 0-300 mmHgSystolic pressure 60-260 mmHGDiastolic pressure 40-199 mmHGPulse 40-180 beats/minute
Accuracy of the indicator	systolic ±3 mmHgdiastolic ±3 mmHg pulse ±5% of the value displayed
Memory 4 x 30 memory locations
Dimensions +/-89 x 60 x 31 mm
Weight +/-97g (without any batteries)
Cuff size 14 - 19.5cm
Admin. operat-ing conditions	+10°C a + 40°C, ≤85% relative air humidity (non-condensing)
Permissible storage conditions	-20°C a +50°C, ≤85% relative air humidity, 800 - 1050 hPa of ambient pressure
Power supply 2 x 1.5 V AAA batteries
Battery lifespan	Approximately 200 measurements, depending on the increased blood pressure and inflation pressure
Accessories Instructions for use, storage box
Ranking Internal power supply, IP22, no AP or APG, continuous use, BF device
Pressure measuring system components	Pump, Valve, LCD, Cuff, Sensor

Changes could be made to the technical features without any prior warning for updating purposes.

• This device complies with European standard EN60601-1-2 and meets the special safety requirements concerning electromagnetic compatibility. Please note that HF portable and mobile communication devices are likely to affect this device. For further details, please contact the after-sales service at the address stated or consult the end of the instructions for use.

EN FR NL DE SL SV

This device complies with European Directive 93/42/EEC for Medical Products, the Medical Products Act as well as European Standards EN1060-1 (pertaining to Non Invasive Blood Pressure Monitoring Equipment, part 1: General Requirements), EN 1060-3 (pertaining to Non Invasive Blood Pressure Monitoring Equipment, part 3: Supplementary Requirements for Electromechanical Blood Pressure Monitoring Equipment) and EC80601-2-30 (Electrical Medical Equipment, parts 2-30: Particular requirements for the safety, including essential performance, of automatic non-invasive blood pressure monitoring equipment).
- The accuracy of this blood pressure monitor has been tested correctly and its durability has been designed for long-term use. Technical measurement checks must be carried out using the appropriate methods when the device is used for medical purposes. For accurate information on how to check the accuracy of the device, you can send a request by post to the after-sales service.

ADVICE REGARDING THE DISPOSAL OF WASTE

All the packaging is composed of materials that pose no hazard for the environment and which can be disposed of at your local sorting centre to be used as secondary raw materials. The cardboard may be disposed of in a paper recycling bin. The packaging film must be taken to your local sorting and recycling centre.

When you have finished using the device, please dispose of it in an environmentally friendly way and in accordance with the law. Prior to disposal, please remove the battery and dispose of it at a collection point so that it can be recycled.

Under no circumstances should spent batteries be disposed of with household waste.

EC 0197 DECLARATION DE CONFORMITY

Medical device Category IIa.

We, LANAFORM,

hereby declare that the medical device "WBPM-100" Lot001 LA090205 complies with European Directive 93/42/EC concerning medical devices and its most recent amendment 2007/47/EC.

LIMITED WARRANTY

LANAFORM guarantees this product against any material or manufacturing defect for a period of two years from the date of purchase, except in the circumstances described below.

The LANAFORM guarantee does not cover damage caused as a result of normal wear to this product. In addition, the guarantee covering this LANAFORM product does not cover damage caused by abusive or inappropriate or incorrect use, accidents, the use of unauthorized accessories, changes made to the product or any other circumstance, of whatever sort, that is outside LANAFORM's control.

LANAFORM may not be held liable for any type of circumstantial, indirect or specific damage.

All implicit guarantees relating to the suitability of the product are limited to a period of two years from the initial date of purchase as long as a copy of the proof of purchase can be supplied.

On receipt, LANAFORM will repair or replace your appliance at its discretion and will return it to you. The guarantee is only valid through LANAFORM's Service Centre. Any attempt to maintain this product by a person other than LANAFORM's Service Centre will render this guarantee void.

ELECTROMAGNETIC COMPATIBILITY INFORMATION

Guidance and manufacture's declaration - electromagnetic emissions

WBPM-100 is intended for use in the electromagnetic environment specified below. The customer or the user of WBPM-100 should assure that it is used in such an environment.
Emissions test Compliance Electromagnetic environment - guidance
RF emissions	Group 1 WBPM-100 uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.
CISP R 11
RF emissions	Class B WBPM-100 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.
CISP R 11
Harmonic emissions	Not applicable
IEC 61000-3-2
Voltage fluctuations/flicker emissions	Not applicable

Guidance and manufacturer's declaration - electromagnetic immunity

WBPM-100 is intended for use in the electromagnetic environment specified below. The customer or the user of WBPM-100 should assure that it is used in such an environment.
Immunity test	IEC 60601test level	Compliance level	Electromagnetic environment - guidance
Electrostatic discharge (ESD)	±6 kV contact	±6 kV contact	Floors should be wood, concrete or ceramic tile. If
IEC 61000-4-2	±8 kV air	±8 kV air	floors are covered with synthetic material, the relative humidity should be at least 30%.
Power frequency (50/60 Hz)	3 A/m 3 A/m Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment.
Magnetic field
IEC 61000-4-8

Guidance and manufacturer's declaration - electromagnetic immunity

WBPM-100 is intended for use in the electromagnetic environment specified below. The customer or the user of WBPM-100 should assure that it is used in such an environment.
Immunity test	IEC 60601test level	Compliance level	Electromagnetic environment - guidance
Radiated RF	3 V/m 80 MHz	3 V/m Portable and mobile RF communications equipment should be used no closer to any part of WBPM-100, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Recommended separation distance d = 2.3√P 800 MHz to 2,5 GHzWhere P is the maximum output power rating of the transmit ter in watt ts (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 should be less than the compliance level in each frequency range. bInterference may occur in the vicinity of equipment marked with the following symbol:
IEC 61000-4-3	to 2.5 GHz
NOTE 1: At 80 MHz and 800 MHz, 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.
a: Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which WBPM-100 is used exceeds the applicable RF compliance level above, WBPM-100 should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating WBPM-100. b: Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.

Recommended separation distances between portable and mobile RF communications equipment and WBPM-100

WBPM-100 is intended for use in an electromagnetic environment in which radiated RF disturbances are con-trolled. The customer or the user of WBPM-100 can help prevent electromagnetic inter ference by main taining a minimum distance between portable and mobile RF communications equipment (transmitters) and WBPM-100 as recommended below, according to the maximum output power of the communications equipment.
Rated maximum output power of transmitterW	Separation distance according to frequency of transmitterm
	150 kHz to 80 MHzd = 1.2√P	80 MHz to 800 MHzd = 1.2√P	800 MHz to 2,5 GHzd = 2.3√P
0,01 0.12 0.12 0.23
0,10 3.8 0.38 0.73
1 1.2 1.2 2.3
10 3.8 3.8	7.3
100	12 12 23
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 transmit ter 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 af-fected by absorption and reflection from structures, objects and people.

Representant European

C∈0197

EHP

Representant européen

Alarm technique - Description

DECLARATION DE CONFORMITE CEO197

Dispositif Medica/ Classe Ila.

OMSCHRIJVING VAN HET APPARAAT

FOUTMELDING/FOUTEN OPLOSSEN

BESCHRANKTE GARANTIE

UTVÄRDERA RESULTATEN

Hjärtrytmproblem

MANUFACTURER & IMPORTER

LANAFORM SA

POSTAL ADDRESS

No. 3 Jinping Street, Ya An Road, Nankai

District, Tianjin 300190, P.R.C.

LOTUS GLOBAL CO., LTD.

ir Seasons Terrace

West Drayton, Middlesex

London, UB7 9GG, United Kingdom