IL 60 - Light therapy BEURER - Free user manual and instructions

USER MANUAL IL 60 BEURER

These instructions for use

1. Getting to know your device

Dear customer, Thank you for choosing one of our products. Our brand stands for well-engineered, quality made products; driven by innovation and safety. Our product range encompass- es a wealth of products for health and well-being in the heat, weight, blood pressure, body temperature, pulse, gentle therapy, massage and air sectors. Please read these instructions for use carefully and keep them for later use. Be sure to make them accessible to other users and observe the information they contain. With kind regards, Your Beurer team Application area This nebuliser is an inhalation device for atomising liq- uids and liquid medication (aerosols) and for the treat- ment of the upper and lower airways. By nebulising and inhaling the medication prescribed/ recommended by your doctor, you can prevent diseases affecting the airways, or in the case that you contract such an illness, you can alleviate symptoms and speed up your recovery. Ask your doctor or pharmacist for fur- ther information about the potential applications. The device is suitable for domestic use. Inhaler medica- tion should only be used following instructions to do so from a doctor. Ensure you are calm and relaxed when inhaling the medication and breathe slowly and deeply to ensure that the medication reaches right down to the lower bronchi. Breathe out normally. The device does not need to be calibrated. Once it has been properly prepared, the device can be used again. Preparation involves replacing all the accessories, including the atomiser and air filter, and disinfecting the surface of the device using a standard disinfectant. Please note that all accessories should be replaced if the device is used by more than one person.

2. Signs and symbols

The following symbols appear in these instructions for use. Warning Warning instruction indicating a risk of injury or damage to health. Important Safety note indicating possible damage to the device/accessory. Note Note on important information. ENGLISH

1. Getting to know your device ............................... 14

4. Description of the device and accessories ......... 17

The following symbols are used on the packaging and on the type plate for the device and accessories. Application part, type BF Observe the instructions for use Protection class 2 device

Serial number 30 ON / 30 OFF 30 minutes of operation, then 30 minutes break before operating again. IP 22 Protected against solid foreign objects 12.5mm in diameter and larger, and against drops of water when the housing is angled up to 15° The CE labelling certifies that the product complies with the essential requirements of Directive 93/42/EEC on medical devices.

3. Warnings and safety notes

Before use, ensure that there is no visible damage to the device or accessories. If you have any doubts, do not use the device and contact your retailer or the specified Customer Service address.

In the event of device faults, please see Chapter “10.Troubleshooting”.

The device is not a substitute for medical consulta- tion and treatment. Always consult your doctor first if you are experiencing any pain or are suffering from an illness.

If you have health concerns of any kind, consult your GP.

Please note the general hygiene measures when using the atomiser.

You should always follow the instructions of your doctor regarding the type of medication to use, the dosage, and the frequency and duration of inhalation.

Only use medication prescribed or recommended by your doctor or pharmacist. Please note: For treatment, only use parts indicated by your doctor according to the particular diagnosis.

Check whether there are contraindications for use with the usual systems for aerosol treatment on the medi- cation instruction leaflet.

If the device does not work properly, or you feel unwell or experience pain, stop using it immediately.

Keep the device away from your eyes when it is in use, as the mist of medication could be harmful.

Changes to the device are not permitted.

Never use the device near flammable gases, oxygen or nitrogen oxide.

This device is not intended for use by children or peo- ple with restricted physical, sensory (e.g. reduced sen- sitivity to pain) or mental skills or a lack of experience and/or lack of knowledge, unless they are supervised by a person who is responsible for their safety or are instructed by such a person in how to use the device.

Check in the medicine package leaflet for possible contraindications for use with common aerosol therapy systems.

The device must be switched off and the plug pulled out before every cleaning and/or maintenance proce

Keep packaging material away from children (risk of suffocation).

To avoid the risk of entanglement and strangulation, store cables and air lines out of the reach of small children.

Do not use any additional parts that are not recom- mended by the manufacturer.

The device must only be connected to the mains volt- age that is specified on the type plate.

Never submerge the device in water and do not use it in the bathroom. Under no circumstances may liquid enter the device.

Protect the device from heavy impact.16

Never touch the micro USB cable with wet hands, as you could get an electric shock.

Do not pull the mains adapter out of the socket using the micro USB cable.

Do not crush or bend the micro USB cable, pull it over sharp-edged objects or leave it dangling down, and protect it from sources of heat.

We recommend that the micro USB cable is complete- ly unrolled to avoid dangerous overheating.

If the micro USB cable or the mains adapter of this device is damaged, it must be disposed of. Please contact Customer Services or the retailer.

If the device is opened, there is a risk of electric shock. Disconnection from the power supply network is only guaranteed if the adapter is unplugged and the micro USB cable has no other power connection.

Making modifications to the device or accessories is not permitted.

If the device has been dropped, exposed to high levels of moisture or suffered any other damage, it must no longer be used. If in doubt, contact Customer Services or the retailer.

The IH 60 nebuliser may only be operated with com- patible Beurer atomisers and with the appropriate Beurer accessories. The use of atomisers and acces- sories made by other companies may result in less efficient treatment and could damage the device.

Keep the device and accessories out of the reach of children and pets. Important

Power cuts, sudden interference or other unfavour- able conditions could lead to the device becoming inoperable. We therefore recommend that you obtain a replacement device or medication (the latter should be agreed with your doctor).

Should you require an adapter or extension lead, this must meet the applicable safety requirements. The power limit and the maximum output specified on the adapter must not be exceeded.

Do not store the device or the power cable near to sources of heat.

Do not use the device in a room in which a spray has previously been used. Air the room before carrying out the treatment.

Never use the device if it is making an abnormal sound.

For hygiene reasons, it is essential that every user uses their own accessories.

Always disconnect the mains adapter from the device after use.

Store the device in a location protected against cli- matic influences. The device must be stored in the environmental conditions specified. Notes on handling batteries

If your skin or eyes come into contact with fluid from a rechargeable battery cell, flush out the affected areas with water and seek medical assistance.

Choking hazard! Small children may swallow and choke on rechargeable batteries. Store rechargeable batteries out of the reach of small children.

Protect batteries from excessive heat.

Risk of explosion! Never throw batteries into a fire.

Do not disassemble, split or crush the rechargeable batteries.

Batteries must be charged correctly prior to use. The instructions from the manufacturer and the specifica

tions in these instructions for use regarding correct charging must be observed at all times.

Fully charge the battery prior to initial use (see Chapter 5).

In order to achieve as long a battery service life as possible, fully charge the battery at least twice per year. General notes Important

The device is only to be used: – On humans – For the purpose for which it is designed (aerosol inhalation) and in the manner specified in these in- structions for use.

Any form of improper use can be dangerous.17

In the event of an acute emergency, the provision of first aid has top priority.

Apart from the medication, only use distilled water or a saline solution. Other liquids may cause a fault in the nebuliser or atomiser.

This device is not intended for commercial or clinical use; it is designed exclusively for self-treatment in a private home. Prior to initial use Important

Remove all packaging material before using the de- vice.

Protect the device against dust, dirt and humidity and never cover the device while it is in use.

Do not operate the device in a very dusty area.

Switch the device off immediately if it is faulty or not working properly.

The manufacturer is not liable for damage resulting from improper or careless use. Repairs Note

Under no circumstances should you open or repair the device yourself, as faultless functionality can no longer be guaranteed thereafter. Failure to comply will result in voiding of the warranty.

The device is maintenance-free.

For repairs, please contact Customer Services or an authorised retailer.

4. Description of the device and

accessories Overview of nebuliser

Setting up the device Take the device out of the packaging. Place the device on a flat surface. Before using the device for the first time Note

Clean and disinfect the atomiser and accessories be- fore using them for the first time. See “Cleaning and disinfection” on page

Connect the compressed air hose [8] to the bottom of the medication container [10].

Connect the other end of the compressed air hose [8] to the nebuliser hose connection [6] by turning it slightly. Charging the nebuliser battery To charge the nebuliser battery, proceed as follows:

Plug the micro USB cable included in delivery into the micro USB port on the nebuliser as shown.

Plug the other end of the micro USB cable into the USB port on the mains adapter and insert the mains adapter into the socket. Note During the charging procedure, between one (battery al- most empty) and four (battery fully charged) LEDs on the battery status indicator [2] flash according to the battery charge status. As soon as the battery is fully charged, all four LEDs are permanently illuminated. Switching on the nebuliser To turn on the nebuliser, proceed as follows:

Press the ON/OFF button on the nebuliser. The ON/ OFF button illuminates blue. The nebuliser is now op- erational. The battery must be sufficiently charged for the nebuliser to function correctly. Note The blue LEDs on the battery status indicator show the current battery state. 1 blue LED flashes = Battery is almost flat, nebu- liser will soon switch off. 1 blue LED lights up = Battery capacity 25% 2 blue LEDs light up = Battery capacity 50% 3 blue LEDs light up = Battery capacity 75% 4 blue LEDs light up = Battery capacity 100%

For hygiene reasons, it is essential to clean the atom- iser [9] and the accessories after each treatment and to disinfect them after the last treatment of the day.

The accessories may only be used by one person; use by several people is not recommended.

If the treatment involves inhaling several different medications one after the other, please be aware that the atomiser [9] must be rinsed under warm tap water following every usage. See “Cleaning and disinfection” on page 20.19

Please observe the notes on changing the filter in these instructions for use.

Check that hose connectors are firmly attached to the nebuliser [6] and the atomiser [9] before each use of the device.

Before use, check the device is working correctly by briefly switching on the nebuliser (together with the connected atomiser, but without medication). If air comes out of the atomiser [9], the device is working.

6.1 Inserting the atomiser insert

• Open the atomiser [9] by twisting the top anticlock- wise against the medication container [10]. Place the atomiser insert [11] into the medication container [10].

• Ensure that the cone for administering medication fits well on the cone for the air duct inside the nebuliser.

6.2 Filling the atomiser

• Fill with an isotonic saline solution or pour the medication directly into the medication container [10]. Avoid overfilling. The maximum rec- ommended filling quantity is 6ml.

• Use medication only as instructed by your doctor and ask about the appropriate inhalation period and quantity for you.

cation is less than 2ml, top this up to at least 2ml with isotonic saline solution. Dilution is also necessary with viscous medications. Here too, please observe the instructions of your doctor.

6.3 Closing the atomiser

• Close the atomiser [9] by twisting the top clockwise against the medication container [10]. Ensure that the connection is correct.

6.4 Connecting accessories to the atomiser

Connect the atomiser [9] to the desired accessory (mouthpiece [12], adult mask [13], children’s mask[14] or nosepiece [15]). Note The most effective form of nebulisation is by using the mouthpiece. Nebulisation using a mask is only recom

mended if it is not possible to use a mouthpiece (e.g. for children who are not yet able to inhale medication using a mouthpiece). If you are using the adult mask [13], you can secure it to your head with the adult mask strap. There is also a strap for the children’s mask [14].

• Before the treatment, pull the atomiser upwards out of the holder [4].

• Start the nebuliser using the On/Off switch [1].

• Spray mist pouring out of the atomiser indicates that the device is operating correctly.

When inhaling, sit upright and relaxed at a table and not in an armchair to avoid compressing the airways and therefore impairing the effectiveness of the treat

Breathe in the atomised medication deeply. Important The device is not suitable for continuous operation; after 30 minutes of operation it must be switched off for 30 minutes. Note During the treatment, hold the atomiser straight (vertical- ly), otherwise the atomisation will not work and faultless functionality is not guaranteed. Important Essential oils, cough syrups, gargling solutions and drops to be used as a rub or in a steam bath are wholly unsuit- able for inhalation using a nebuliser. These additions are often viscous and can impair the correct functioning of the device and therefore the effectiveness of the applica- tion in the long-term. For individuals with a hypersensitive bronchial system, medications containing essential oils may under certain conditions cause an acute bronchos

pasm (a sudden cramp-like restriction of the bronchi with

shortness of breath). Consult your doctor or pharmacist in relation to this matter.

6.6 Stopping inhalation

Once the mist is only coming out in an irregular flow or if the sound changes when inhaling, you can stop the treatment.

Switch off the nebuliser after treatment using the On/ Off switch [1] and disconnect it from the mains.

Place the atomiser [9] back in its holder [4] after the treatment.

See “Cleaning and disinfection” on page 20.

7. Changing the filter

In normal operating conditions, the air filter must be re- placed after approx. 100 operating hours or one year. Please check the air filter regularly (after 10–12 nebu- lisation procedures). Replace the used filter if it is very dirty or clogged. If the filter has become damp, it must also be exchanged for a new filter. Important

Do not attempt to clean the used filter and reuse it.

Only use the manufacturer’s original filter, otherwise your nebuliser may become damaged and sufficiently effective treatment cannot be guaranteed.

Do not repair or maintain the air filter while it is in use.

Never operate the device without a filter. To replace the filter, proceed as follows: Important

First switch the device off and disconnect it from the mains.

Allow the device to cool down.

1. Pull off the filter cap [5]

towards the front. Note If the filter remains in the device after the cap has been removed, take the filter out of the device, e.g. with twee- zers or similar.

2. Re-insert the filter cap [5] with a new filter.

3. Ensure that it is securely in place.

8. Cleaning and disinfection

Atomiser and accessories Warning Adhere to the following hygiene instructions to avoid health risks.

The atomiser [9] and accessories are designed for mul- tiple use. Please note that different areas of application involve different requirements in terms of cleaning and hygienic preparation. Notes:

Do not clean the atomiser or the accessories mechan- ically using a brush or similar device, as this could cause irreparable damage and it will mean that the best treatment results can no longer be guaranteed.

Please consult your doctor about the additional require- ments in terms of the hygienic preparation required (hand care, handling of medication/inhalation solutions) for high-risk groups (e.g. patients with cystic fibrosis).

Ensure thorough drying after each cleaning or disin- fection process. Residual moisture or wetness can represent an increased risk of bacterial growth. Preparation

Immediately after each treatment, all parts of the atomiser [9] and the ac- cessories used must be cleaned of re- sidual medication and contamination.

To do this, dismantle the atomiser [9] into its individual parts.

• Dismantle the atomiser by twisting the top anticlock

wise against the medication container [10].

• Reassembly is carried out in reverse order. Cleaning Important The device must be switched off, disconnected from the mains and allowed to cool down each time before cleaning. The atomiser and the accessories used such as the mouthpiece, mask, etc. must be washed with hot but not boiling water after each use. Dry the parts carefully using a soft cloth. Put the parts together again when they are completely dry and place them in a dry, sealed container or disinfect them. When cleaning, ensure that any residue is removed. Nev- er use any substances for cleaning that could potentially be toxic if they came into contact with the skin or mu- cous membranes, or if they were swallowed or inhaled. Use a soft, dry cloth and non-abrasive cleaning products to clean the device. Do not use any abrasive cleaning products and never submerge the device in water. Important

Ensure that no water gets inside the device.

Do not clean the device or accessories in the dish- washer.

Do not touch the device with wet hands when it is plugged in and do not allow water to spray on the device. Only operate the device if it is completely dry.

If liquid penetrates the device this could cause damage to the electrics or other nebuliser parts and lead to a malfunction. Condensation, hose care Condensation may form in the hose depending on the ambient conditions. It is essential to remove the moisture to prevent bacterial growth and ensure proper treatment. To do so, proceed as follows:

Remove the compressed air hose [8] from the atomiser [9].

The hose must remain connected to the nebuliser[6].

Operate the nebuliser until the moisture is removed by the air passing through.

In the event of heavy contamination, replace the hose. Disinfection Please carefully observe the points below when disin- fecting your atomiser and accessories. We recommend disinfecting the individual parts on a daily basis after the last usage as a minimum measure. (All you need for this is a little white vinegar and distilled water.)

First, clean the atomiser and accessories as described in the “Cleaning” section.

Place the disassembled nebuliser, mouthpiece, and nosepiece in boiling water for five minutes.

For the remaining accessories, use a vinegar solution consisting of ¼ vinegar and ¾ distilled water. Make sure that the volume is sufficient to fully submerse the parts, such as the atomiser, mask and mouthpiece, in the solu- tion.

Leave the parts in the vinegar solution for 30 minutes.

Rinse the parts with water and dry them carefully with a soft cloth. Important Do not boil or autoclave the compressed air hose or the masks.

Put the parts together again when they are completely dry and place them in a dry, sealed container. Note

Please ensure that the parts are completely dried af- ter cleaning, otherwise the risk of bacterial growth is increased.

Use cold disinfection solution in accordance with the manufacturer’s instructions. Drying

Place the individual parts on a clean, dry and absor- bent surface and leave them to dry completely (at least 4 hours).22 Durability of materials

As with any plastic parts, atomisers and their accesso

ries are affected by a certain amount of wear and tear when used and hygienically prepared on a frequent ba- sis. Over time, this can lead to a change in the aerosol, which can have a negative effect on the efficiency of the treatment. We therefore recommend that you replace the atomiser and other accessories after a year.

The following point should be observed when selecting the cleaning product or disinfectant: only use a mild cleaning product or disinfectant in the concentration and volume prescribed by the manufacturer. Storage

Do not store in damp conditions (such as in a bathroom) and do not transport with any damp items.

When storing and transporting, protect from prolonged direct sunlight.

The accessories can be stowed securely in the ac- cessory compartment. Store the device in a dry place, ideally in the original packaging.

For environmental reasons, do not dispose of the device in the household waste. Please dispose of the device in accordance with EC Directive – WEEE (Waste Electrical and Electronic Equipment). If you have any questions, please contact the local authorities responsible for waste disposal. The empty, completely flat rechargeable batteries must be disposed of through specially designated collection boxes, recycling points or electronics retailers. You are legally required to dispose of the rechargeable batteries. The codes below are printed on rechargeable batteries containing harmful substances: Pb = Battery contains lead, Cd = Battery contains cadmium, Hg = Battery contains mercury

1. Too much or too little medication

in the atomiser. Minimum: 2ml, Maximum: 6ml.

Check nozzle for blockages. Clean nozzle if necessary (e.g. by rinsing out). Then start using the atomiser again. IMPORTANT: Carefully pierce the fine holes from the underside of the nozzle only.

3. Atomiser not held vertically.

4. Unsuitable medication fluid added

scribed by the doctor. The output is too low. Kinked hose, clogged filter, too much inhalation solution. What med

ications are suitable for inhaling? Please consult your doctor in rela

tion to this matter. As a rule, all medication that is suitable and approved for device inhalation can be inhaled. There is inha

lation solution residue in the atomiser. This is normal and is due to technical reasons. Stop inhalation once the atomiser starts to make a notably different sound.23 Problem/ question Possible cause/remedy What should be taken into account when using the device with infants and children?

1. On infants and children, the mask

should cover the mouth and nose to ensure effective inhalation.

2. On children, the mask should also

cover both the nose and mouth. It is not a good idea to carry out nebulisation on someone who is sleeping, as in this case not enough of the medication will reach the lungs. Note: Inhalation should only be car

ried out under the supervision of an adult and with their assistance and the child should not be left alone. Inhalation us

ing the mask takes longer. This is due to technical reasons. You breathe less medication per breath through the holes of the mask than via the mouthpiece. The aerosol is mixed with ambient air via the holes. Why should the atomiser be replaced regularly? There are two reasons for this:

tive particle spectrum, the nozzle hole must not exceed a specific diameter. Due to mechanical and thermal stresses, the plastic is subject to a certain degree of wear. The atomiser insert [11] is particularly sensitive. This can also alter the composition of the aero

sol droplets, which directly affects the effectiveness of the treatment.

2. Regularly changing the atomiser

is also recommended for hygiene reasons. Should each person have their own atomiser? Yes, this is absolutely essential for hygiene reasons.

Li-Ion Subject to technical changes. The serial number is located on the device or in the bat- tery compartment.24 Particle size diagram Measurements were performed using a sodium fluoride solution with a “Next Generation Impactor” (NGI). The diagram may therefore not be applicable to sus- pensions or highly viscous medications. You can obtain more detailed information from the manufacturer of your medication. Replacement items Designation Material REF Year pack (contains mouth

piece, nosepiece, adult mask, children’s mask, atomiser, compressed air hose, filter) PP/PVC

Note If the device is not used according to the instructions specified, perfect functionality cannot be guaranteed! We reserve the right to make technical changes to improve and develop the product. This device and its accesso

ries comply with the European standards EN60601-1, EN60601-1-2 and EN13544-1 and are subject to particu- lar precautions with regard to electromagnetic compatibil- ity. Please note that portable and mobile HF communica- tion systems may interfere with this device. More details can be requested from the stated Customer Services address or found at the end of the instructions for use. This device meets the requirements of European Directive 93/42/EEC for medical devices, as well as those of the Medizinproduktegesetz (German Medical Devices Act). ELECTROMAGNETIC COMPATIBILITY

The device complies with the currently valid require- ments relating to electromagnetic compatibility and is suitable for use in all buildings including those designated for private residential purposes. The radio frequency emissions of the device are extremely low and are very unlikely to cause interferences with other devices in the vicinity.

We recommend never placing the device on top of or near to other devices. If interference does occur with your other electrical devices, move the device or connect it to a different mains socket.

• Radio devices can have an influence on the operation of the device.

Zastrzega się prawo do pomyłek i zmian95 Electromagnetic Compatibility Information Table 1 Guidance and manufacturer’s declaration – electromagnetic emissions The IH 60 is intended for use in the electromagnetic environment specified below. The customer or the user of the IH 60 should assure that it is used in such an environment Emission test Compliance Electromagnetic environment – guidance Emissions RF CISPR 11 Group 1 The IH 60 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 equip

ment. RF Emissions CISPR 11 Class B The IH 60 is suitable for use in all establishments including domestic and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes. Harmonic emissions

Class A Voltage fluctuations/flicker emissions

Complies Table 2 Guidance and manufacturer’s declaration – electromagnetic immunity The IH 60 is intended for use in the electromagnetic environment specified below. The customer or the user of the IH 60 should assure that it is used in such an environment. Immunity test IEC 60601 Test level Compliance level Electromagnetic environment – guidance Electrostatic discharges

±8 kV contact ±15 kV air ±8 kV contact ±15 kV air Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30 %. Electrical fast transient/burst

Power supply lines :±2 kV input/output lines:±1 kV Power supply lines :±2 kV Mains power quality should be that of a typical commercial or hospital environment. Surge

line(s) to line(s): ±1 kV line(s) to earth: ±2 kV 100 kHz repetition frequency line(s) to line(s): ±1 kV Mains power quality should be that of a typical commercial or hospital environment. Voltage dips, short interrup

tions and voltage variations on power supply input lines

30 A/m 50Hz/60Hz 30 A/m 50Hz/60Hz Power frequency magnetic fields should be at levels characteristic of a typical location in a typi

cal commercial or hospital environment. NOTE: U

is the a.c. mains voltage prior to application of the test level.96 Table 3 Guidance and manufacturer’s declaration – electromagnetic immunity The IH 60 is intended for use in the electromagnetic environment specified below. The customer or the user of the IH 60 should assure that it is used in such an environment. Immunity test IEC 60601 test level Compliance level Electromagnetic environment – guidance Conduced RF

Radiated RF IEC61000- 4-3 150kHz to 80MHz:

rms 6 V rms (in ISM and amateur radio bands) 80% Am at 1kHz 10V/m 80% Am at 1kHz 150kHz to 80MHz: 3Vrms 6 Vrms (in ISM and amateur radio bands) 80% Am at 1kHz 10V/m 80% Am at 1kHz Portable and mobile RF communications equipment should be used no closer to any part of the IH 60 including cables, than the recommended separation distance calculated from the equation applicable to the frequency the transmitter. Recommended separation distance: d = 0.35 d = 1.2 80 MHz to 800 MHz d = 1.2 800 MHz to 2.7 GHz d = 2,3 Where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in metres (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.

Interference may occur in the vicinity of equipment marked with the following symbol: 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 aected by absorption and reflection from struc

tures, objects and people.

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 the IH 60 is used exceeds the applicable RF compliance level above, the IH 60 should be observed to verify normal operation. If abnormal per

formance is observed, additional measures may be necessary, such as re-orienting or relocating the IH 60.

Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m. Table 4 Recommended separation distances between portable and mobile RF communications equipment and the IH 60 The IH 60 is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the IH 60 can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the IH 60 as recommended below, according to the maximum output power of the communications equipment. Rated maximum output power of transmitter (W) Separation distance according to frequency of transmitter (m) 150 kHz to 80 MHz (out ISM and amateur radio bands) d = 1.2 150 kHz to 80 MHz (out ISM and amateur radio bands) d = 0.6 80 MHz to 800 MHz d = 1.2 800 MHz to 2.7 GHz d = 2.3

For transmitters rated at a maximum output power not listed above, the recommended separation distance d in metres (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer. NOTE 1 At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies. NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is aected by absorption and reflection from struc

tures, objects and people.97 Table 5 Guidance and manufacturer’s declaration - electromagnetic emissions The IH 60 is intended for use in the electromagnetic environment specified below. The customer or the user of the IH 60 should assure that it is used in such an environment Radiated RF

NOTE: If necessary to achieve the IMMUNITY TEST LEVEL, the distance between the transmitting antenna and the ME EQUIPMENT or ME SYSTEM may be reduced to 1 m. The 1 m test distance is permitted by IEC 61000-4-3. a) For some services, only the uplink frequencies are included. b) The carrier shall be modulated using a 50 % duty cycle square wave signal. c) As an alternative to FM modulation, 50 % pulse modulation at 18 Hz may be used because while it does not represent actual modulation, it would be worst case. The MANUFACTURER should consider reducing the minimum separation distance, based on RISK MANAGEMENT, and using hig

her IMMUNITY TEST LEVELS that are appropriate for the reduced minimum separation distance. Minimum separation distances for higher IMMUNITY TEST LEVELS shall be calculated using the following equation: E=6/d Where P is the maximum power in W, d is the minimum separation distance in m, and E is the IMMUNITY TEST LEVEL in V/m.9899100