Phototherapy Lamp Instruction for use Rev B Dec 2006

Instructions for use ... 2 - 16 Instrucciones de uso... 17 - 32 Manual de utilização ... 33 - 46 ȅįȘȖȓİȢ ȤȡȒıȘȢ ... 47 - 61 Technical Description ... 62 - 63

Medela AG Medical Technology Lättichstrasse 4 6341 Baar / Switzerland Tel. 041 769 51 51 Fax 041 769 51 00 e-mail: [email protected] www.medela.ch

Instructions for Use

EU Representative Germany Medela Medizintechnik Postfach 1148 85378 Eching Tel. 089 319 759-0 Fax 089 319 759 99 e-mail: [email protected] www.medela.de

Phototherapy Lamp

page 1

Instructions for use

Phototherapy Lamp

Contents

Page

1.

Safety note...3

2.

Description...4

3.

Application ...4

4.

Equipment...4

5.

Assembly ...5 5.1 Assembling the stand...5 5.2 Installing the fluorescent tubes ...5 5.3 Different positions ...6 5.4 Rollers / Breaks...7

6.

Irradiation levels...7

7.

Commissioning the phototherapy lamp...10

8.

LED display...11

9.

Therapy...11

10.

Maintenance ...12 10.1 Replacing the starter ...12 10.2 Changing the fluorescent tubes ...13 10.3 Testing the LED-warning light...13 10.4 Cleaning and disinfecting...14

11.

Disposal ...14

12.

Technical data ...15

13.

What the symbols mean...15

14.

Ordering references...16

15.

Warranty ...16

Instructions for use

Phototherapy Lamp

page 2

Dear Client, We would like to congratulate you on purchasing the Medela Phototherapy Lamp. We are confident that you have made the right choice and that you will be fully satisfied. The following pages show you how to use and maintain the Phototherapy Lamp. If these instructions are followed carefully, your Phototherapy Lamp will have a long and reliable operating life. We would like to thank you for the confidence you have placed into our company by purchasing this product. We develop and produce our products with a certified quality-management system according to EN ISO 13485:2003, as well as according to the guidelines of the American FDA for GMP. ISO EN FDA GMP

International Organisation for Standardization European Norm Food and Drug Administration Good Manufacturing Practices

Medela AG reserves the right to change technical specifications for the improvement of the product at any time without prior notice.

1.

Safety note Working with the Phototherapy Lamp requires precise knowledge of its areas of application as well as adherence to these instructions. In cases where there is any uncertainty, trained staff familiar with the equipment must be consulted. Caution Nursing staff: This lamp emits blue light in the wavelength of 425-475 which may harm the retina in some cases. You may want to avoid prolonged use/exposition if: - you have a pre-existing ocular condition such as macular degeneration - you are diabetic or otherwise at risk for retinal damage - you are taking photosensitizing medication such as nonsteroidal anti-inflammatory drugs, most antidepressants, some antibiotics, diuretics and beta-blockers and other heart medications. - you are 55+ years of age Patient: - Patients being treated with the Phototherapy Lamp must wear eye protection The Phototherapy Lamp must be used outside of an incubator or with a warming bed. The Phototherapy Lamp may not be used in environments - where there is a risk of explosion - enriched with oxygen. When used with an incubator there must be enough room between the devices to ensure proper ventilation, in order to prevent an accumulation of oxygen. N.B. The use of these lamps for anything but their intended purpose can be hazardous. Portable and mobile RF communication devices may influence the device. In each of the following cases, the device must not be used and it must be repaired by Customer Services: - If the power cable or the plug are damaged - If the device is not functioning perfectly - If the device is damaged - If the device shows clear safety defects.

Instructions for use

Phototherapy Lamp

page 3

2.

Description Medela's phototherapy lamp is a high quality product developed for the treatment of neonatal hyperbilirubinaemia. It meets the highest demands in making optimum use of the effective light spectrum and in energy savings. As a result of using energy-saving fluorescent tubing, heat development has been considerably reduced in comparison with conventional equipment. Operating costs are therefore lower and there are no effects on surroundings (e.g. temperature control of infant incubators). This modern concept offers many advantages both for successful therapy as well as for nursing staff.

3.

Application Indications: Medela's phototherapy lamp is intended for the efficient and safe treatment of excessive serum-bilirubin concentrations in newborn babies. Contraindications: A rapidly increasing bilirubin value may require a more intensive therapy. In these cases, several Medela phototherapy lamps can be used simultaneously. Specially designed for this purpose, the wheeled stand enables the lamps to be positioned next to each other. The phototherapy lamp must be used outside of an incubator or with a warming bed. If these are not necessary, we recommend using a BiliBed for the therapy. When used with an incubator there must be enough room between the devices to ensure proper ventilation, in order to prevent an accumulation of oxygen. The phototherapy lamp is not admitted for use: - in hazardous locations - in areas which may be enriched with oxygen. N.B. The use of these lamps for anything but their intended purpose can be hazardous. Portable and mobile RF communication devices may influence the device.

4.

Equipment The lamp body contains four compact fluorescent tubes. According to requirements, blue light or white light can be selected or combined. This permits effective treatment in line with requirements. The special tubes which emit blue light in the visible range (425 - 475 nm) are the most suitable for phototherapy. The tubes that emit white light can also be used. This light has a lower therapeutic effect, but is preferred when good light is needed for examination purposes. Any combination of blue and white light is, of course, possible. The fluorescent tubes can be switched on and off in pairs. The light in the tubes effective for therapy is electronically monitored. If the fluorescent tubes need changing an LED warning lamp lights up on the lamp body. The lamp body is equipped with a specially mirrored screen that directs light onto the child and limits light spread. This improves the therapeutic effect and protects surroundings from disturbing blue light. The lamp housing can be infinitely adjusted for height as well as forward and back positions. In addition, it can be rotated up to 90° on both sides for sideways irradiation.

Instructions for use

Phototherapy Lamp

page 4

The mobile stand is equipped with antistatic rollers two of which are fitted with brakes. The ballast units are located in the metal foot, which lowers the centre of gravity for good stability.

5.

Assembly 5.1

Assembling the stand

Fig. 1

5.2

¾

As shown in the illustration, stand the mobile base upright.

¾

Place the column onto the mobile base and fasten it with the 4 screws.

Installing the fluorescent tubes Lamp body

Opening

Lamp grille

a

Retainer

b c

Opening Fluorescent tubes

Fig. 2 a)

Instructions for use

Fig. 3

Remove the lamp grille ¾

Unscrew the bayonet screw (90° turn) (Fig. 2a).

¾

Insert a screwdriver on one side of the lamp body alternatively in the two openings and press lightly outwards until the grille springs out of its holder (Fig. 2b, c).

Phototherapy Lamp

page 5

b)

Insertion of the fluorescent tubes The lamp body can hold four compact fluorescent tubes. Special tubes can be used which emit light mainly in the 425- 475m range and are therefore highly suitable for phototherapy. As stray light is limited, blue light can be used exclusively to provide the greatest therapeutic effect. Tubes with white light can also be used according to requirements. ¾

Insert the fluorescent tubes into the retainer; then push the fluorescent tube into its socket (Fig. 3).

¾

Insert the remaining three tubes in the same way.

N.B.

c)

5.3

With mixed lighting, the blue tubes must always be installed in the outer two positions to enable troublefree functioning of the tube warning display for changing the tubes.

Replace the lamp grille ¾

On the inside of the lamp body there are protruding support ribs. Place the grille on these ribs and press until it clicks in at all four corners.

¾

Tighten the bayonet screw (90° turn).

Different positions
  

  

  

  

 

Fig. 4

Instructions for use

Fig. 5

¾

By turning the two handles illustrated, the clamps can be released or tightened. The lamp can thus be raised or lowered (Fig. 4) or moved forward or back (Fig. 5).

¾

In addition, for side irradiation, the lamp can be turned up to 90° in both directions.

Phototherapy Lamp

page 6

Distance from the baby: ¾

The distance should be kept as small as possible (i.e. approx. 25 cm) for maximum therapeutic effect. When used with an incubator the distance between lamp and upper edge of the incubator must be at least 3 cm. When used with an incubator there must be enough room between the devices to ensure proper ventilation, in order to prevent an accumulation of oxygen. The treatment is most effective when only blue light fluorescent tubes are used (Type Osram Dulux L18W/71 or Ralutec long 18W/71). The efficiency and safety can only be guaranteed when the fluorescent tubes from Medela are used.

¾

5.4

If the distance cannot be kept small (e.g. with some incubators) and the maximum effect is necessary, additional lamps can be used in order to irradiate the baby from above and from the side.

Rollers / Breaks The stand is fitted with antistatic rollers, two of which have brakes. The brakes can be applied by pressing down with a foot on the locking mechanism and released by lifting it.

6.

Irradiation levels According to the study from M. Jeffrey Maisels (Pediatrics Vol. 98, No. 2, August 1996: Why use Homeopathic Doses of Phototherapy) the efficacy of phototherapy depends on three factors: Spectrum of light delivered by the phototherapy unit. Because of the optical properties of bilirubin and skin, the most effective wavelengths are in the blue-green spectrum. Power output of the light. This also depends on the distance of the light from the infant. The lower the distance, the higher the efficacy. Surface area of the infant exposed to phototherapy. The efficacy is higher when more skin is subjected to phototherapy.

Instructions for use

Phototherapy Lamp

page 7

Wave length distribution mit with 2 blauen 2 blueund and2 2 weissen white Fluoreszenzröhren fluorescent tubes 25cm

35cm

45cm

4

2 spektraleirradiance Bestrahlungsstärke [w/m²/5nm] spectral [W/m /5nm]

3.5

3

2.5

2

1.5

1

0.5

0 320

330

340

350

360

370

380

390

400

410

420

430

440

450

460

470

480

490

500

510

520

530

540

550

520

530

540

550

Wellenlänge [nm]

Wave length [nm]

with fluorescent tubes mit44 blue blauen Fluoreszenzröhren 25cm

35cm

45cm

6

2 spektrale Bestrahlungsstärke spectral irradiance [W/m[w/m²/5nm] /5nm]

5

4

3

2

1

0 320

330

340

350

360

370

380

390

400

410

420

430

440

450

460

470

480

490

500

510

Wellenlänge [nm]

Wave length [nm]

Total spectral irradiance, effective surface area = max. irradiance in central area Ebimax (400-550nm) Effective surface area: within this area Ebi
0.4 Ebimax Ambient temperature: (25 2) °C

Instructions for use

Phototherapy Lamp

page 8

Distance from lamp underside to measuring surface 25cm Maximum values Using 4 blue fluorescent tubes: Ebi max (400-550nm) = 44.4 W/m2

Center of phototherapy lamp housing

Using 2 blue and 2 white fluorescent tubes: Ebi max (400-550nm) = 28.6 W/m2

30 cm

Lamp

Holder

Average values Using 4 blue fluorescent tubes: Ebi max (400-550nm) = 30.2 W/m2 Using 2 blue and 2 white fluorescent tubes: Ebimax (400-550nm) = 19.5 W/m2

Effective surface area 40 x 30 cm 15 cm

40 cm

Distance from lamp underside to measuring surface 35cm Center of phototherapy lamp housing

Maximum values Using 4 blue fluorescent tubes: Ebi max (400-550nm) = 26.6 W/m2 Using 2 blue and 2 white fluorescent tubes: Ebi max (400-550nm) = 16.7 W/m2

50 cm

Lamp

Holder

Average values Using 4 blue fluorescent tubes: Ebi max (400-550nm) = 17.4 W/m2 Using 2 blue and 2 white fluorescent tubes: Ebi max (400-550nm) = 10.9 W/m2

Effective surface area 40 x 50 cm

15 cm

40 cm

Instructions for use

Phototherapy Lamp

page 9

Distance from lamp underside to measuring surface 45cm Center of phototherapy lamp housing

Maximum values Using 4 blue fluorescent tubes: Ebi max (400-550nm) = 17.8 W/m2 Using 2 blue and 2 white fluorescent tubes: Ebi max (400-550nm) = 10.5 W/m2

50 cm

Lamp

Average values Using 4 blue fluorescent tubes: Ebi max (400-550nm) = 12.3 W/m2 Using 2 blue and 2 white fluorescent tubes: Ebimax (400-550nm) = 7.3 W/m2

Holder

Effective surface area 50 x 50 cm 25 cm

50 cm

Effective surface area The distance between baby and lamp determines the effective surface area. In order to achieve the best possible effect, the baby should wear smallest diapers. If necessary, roll down the top of the diaper below baby's naval, so that the maximum amount of bare skin will be exposed to the therapeutic light.

7.

Commissioning the phototherapy lamp ¾

Connect the cable to the power supply, ensuring in advance that the voltage matches the details given on the specification plate.

¾

Adjust lamp for position and height.

¾

Ensure that the height adjustment is securely tightened. Then push the phototherapy lamp into place.

¾

Switch on the phototherapy lamp with the on/off switches on the lamp body. The illustrations Fig. 6 - 9 show the different alternatives.

Instructions for use

Phototherapy Lamp

page 10

8.







     

     

      





     

!"## $

LED display When the lamp is switched on, the electronic monitoring of the blue, i.e. the therapeutic, light of the fluorescent tubes is activated. If this proportion of the light sinks to approx. 75%, an optical warning light lights up (Fig. 10). If the optical warning stays on continuously, all the blue tubes need changing. If the display lights up when the phototherapy light is switched on and goes out after a short time (max. 45 minutes), this is of no importance. The tubes only need changing when the display is on continuously. The white light tubes are not monitored, since their proportion of blue light is minimal. They are only replaced when they are no longer on. If the white tubes are installed in the outer position, the LED display is on continuously. For this reason, it is vital to always install the blue light tubes in the outer positions.

9.

Therapy Warning: If the phototherapy lamp is positioned too close to an external source of heat (e.g. heat lamp), the phototherapy lamp could be damaged. For this reason sufficient distance must always be maintained between the equipment. ¾

Ensure that the height adjustment and lamp position are securely tightened.

¾

Place as close to the infant as possible (approx. 25 cm).

Instructions for use

Phototherapy Lamp

page 11

¾

Protect the eyes of the child since blue light can cause undesired side effects (e.g. fatigue, head ache). If necessary, a barrier should be set up to protect the patients adjacent to the phototherapy equipment. Nursing staff should be informed about the possible side effects and should avoid being in the area for prolonged amounts of time.

¾

Check whether the lamp composition, resp. the choice of tubes corresponds to the treatment required. Blue light and white light can be mixed at will, whereby white light is generally less irritating and is more pleasant for the examination of the baby.

¾

Before each use: Check LED warning light – if it lights up, all fluorescent tubes must be replaced. Phototherapy and the use of reflective foils may cause hazardous body temperatures. It is imperative to check the baby's temperature regularly. When used with an incubator, check the necessity to regulate the air temperature and set the incubator on skin-controlled mode.

¾

Monitor the infant during therapy Check the bilirubin levels regularly. Photoisomeres of bilirubin may cause toxic effects. Make sure the infant is lying in the center of the light. Phototherapy influences the infant's water balance. In order to prevent dehydration, it may be necessary to feed the baby more often.

Attention Auxiliary devices which are used in the same area as the phototherapy lamp must comply with the general requirements for safety according to IEC 60601-1. Drugs and infusion liquids shall not be stored in the radiation area. ¾

Continue to monitor the infant.

10. Maintenance Warning

Disconnect power supply before performing maintenance jobs!

10.1 Replacing the starter Opening

Lamp grille

a

b c

Clip

Starter Fluorescent tube Reflecto r

Fig. 11

Instructions for use

Fig. 12

Fig. 13

¾

A faulty starter either causes the fluorescent tubes to flicker for an excessive period of time when switched on or fails to trigger the tubes.

¾

Switch off the unit and disconnect the power cable from its socket.

Phototherapy Lamp

page 12

¾

Remove the lamp grille. Unscrew the bayonet screw (90° turn) (Fig. 11). Insert a screwdriver on one side of the lamp body alternatively in the two openings and press lightly outwards until the grille springs out of its holder.

¾

The four starters are now visible (Fig. 12). The two inner and two outer fluorescent tubes and starters are connected in pairs. It is therefore recommended that the two starters that belong together are always replaced at the same time.

¾

Turn the starter anti-clockwise (approx. a quarter turn) and remove.

¾

Insert new starter (do not use an electronic type!) and turn it clockwise as far as possible.

¾

Replace the lamp grille: On the inside of the lamp body there are protruding support ribs. Place the grille on these ribs and press until it clicks in at all four corners. Tighten the bayonet screw (90° turn).

10.2 Changing the fluorescent tubes ¾

If the proportion of therapeutic light sinks below the minimum level, an optical display will light up when the lamp is switched on. This means that all the blue light lamps need replacing.

¾

Switch off the phototherapy lamp and disconnect from power supply.

¾

Remove the lamp grille. Unscrew the bayonet screw (90° turn) (Fig. 11). Insert a screwdriver on one side of the lamp body alternatively in the two openings and press lightly outwards until the grille springs out of its holder.

¾

Release the fluorescent tubes from the clips and carefully remove them from the sockets (Fig. 12).

¾

Put these tubes aside immediately in order to avoid confusion.

¾

Insert new tubes into the clips and push into the sockets (Fig. 13).

¾

Check whether the lamp grille reflectors are clean and shiny; clean if necessary.

¾

Replace the lamp grille: On the inside of the lamp body there are protruding support ribs. Place the grille on these ribs and press until it clicks in at all four corners. Tighten the bayonet screw (90° turn).

10.3 Testing the LED-warning light The functioning of the LED-warning light which monitors the light intensity, can be tested as follows: ¾ Turn the lamp body so that the fluorescent tubes are facing up. ¾

Remove the lamp grille (as shown under 10.1).

¾

Turn on the outer fluorescent tubes The inner tubes must be turned off for this test, as they could falsify results.

¾

Instructions for use

Make sure that the lamp is not in direct sunlight

Phototherapy Lamp

page 13

¾

Place your finger between the fluorescent tube and the lamp housing. The distance to the sensor should be approximately 10 cm.

¾

Slowly move your finger closer to the sensor and monitor the LED (Figure 14)

Fig. 14 ¾

The LED should not light up in the beginning. When your finger gets closer to the sensor, the LED will light up. Shortly before your finger reaches the sensor, the LED should extinguish.

¾

After completing the test, remount the lamp grille.

10.4 Cleaning and disinfecting The outside surfaces of the phototherapy lamp can be cleaned with a damp cloth. Cleaning or disinfecting agents should not be used in concentrated form! Flammable solutions may not be used for cleaning the phototherapy lamp. Aggressive cleaning agents may damage the plastic housing and cause cracks. If this occurs, the lamp head must be replaced out of safety reasons!

11. Disposal The Phototherapy Lamp is of modular design. It can thus be disassembled into its individual components. The Phototherapy Lamp is mainly made of technical plastics which can be disposed of in accordance with local regulations. The lamp and electric parts should be disposed of separately.

Instructions for use

Phototherapy Lamp

page 14

12. Technical data Power supply Power consumption Lamps Height adjustment range Light emitter Mobile base Weight Design Protection class Fuses Air pressure Relative humidity Operating Temperature Storage and transport temperature Noise level Standards

230 V/50 Hz 120 V/60 Hz 185 VA Fitted with 4 fluorescent tubes, 18W, blue (Osram Dulux L18W/71 or Ralutec long 18W/71) or white light (Osram Dulux L18W/840) 114 - 161 cm 32 cm long, 26 cm wide 60 cm wide, 67 cm deep 10.1 kg IEC 601.1 I, Type B Type Ø 5 x 20, 250 V/T 1 A (230 V) Type Ø 6,3 x 32, 250 V/T 2 A (120 V) 70 – 106 kPa 20 – 95% +10 bis +40°C -20 bis +50°C <20 dB(A) CE (93/42/EEC) EN 60601-1/A2:1995, EN 60601-1-2:2001, EN 60601-2-50:2002

The phototherapy lamp may not be used in environments where there is a risk of explosion. Detailed service documentations including circuit diagrams, spare parts list, etc. are available on request from Medela or from your local Medela agent. Please give the relevant serial number together with any other information on the specification plate fitted to your appliance. Electromagnetic Compatibility (EMC) The Medela phototherapy lamp is a medical device which complies with special safety measurements concerning EMC and must be installed and made ready for use according to the EMC information at the end of these instructions for use. Portable and mobile RF communication devices may influence the device.

13. What the symbols mean Warning - Refer to users instructions Section 6. LED display (light output) and Section 7. Therapy (protection of baby’s eyes)

Type B equipment according to IEC 601.1

Alternating current Protective earth

Eye protection for the patient is necessary

Instructions for use

Phototherapy Lamp

page 15

14. Ordering references Fluorescent tubes: 936.0015 Blue light tube

936.0016 White light tube

15. Warranty Medela AG guarantees the perfect quality and workmanship of this phototherapy lamp for a period of two years from the date of delivery from the works. If the fault is not due to improper use, all defective material will be replaced free of charge during this period. This will not apply to parts subject to wear and tear in use. For example, this applies to the fluorescent tubes, the starters and fuses. No responsibility is accepted for any demands that go beyond this, such as consequential damage, etc. The lamp must be returned to a Medela service agent for warranty claims. Conditions according to IEC 60601-1 (Edition 1990): The manufacturer can only be held liable for any effects on the safety, reliability and performance of the appliance if: -

all installation work, additions, adjustments as well as changes or repairs are carried out by persons so authorized by the manufacturer; the electrical installation in the room concerned corresponds to IEC specifications; the appliance is used in conformity with its instructions for use.

In general, it is presupposed that the device is used under supervision of qualified or authorized staff and that the user has the necessary specialized knowledge for using the phototherapy lamp.

Instructions for use

Phototherapy Lamp

page 16

Technical Description Electromagnetic Compatibility (EMC, IEC 60601-1-2) IEC 60601-1-2, Table 201 Electromagnetic Emissions The Phototherapy Lamp is intended for use in the electromagnetic environment specified below. The customer or the user of the Phototherapy Lamp should assure that it is used in such environment. Emission Tests

Compliance

Electromagnetic environment - guidance

RF emissions CISPR 11

Group 1

RF emissions CISPR 11

Class B

Harmonic emissions IEC 61000-3-2

Class A

Voltage fluctuations / flicker emissions IEC 60000-3-3

Complies

The Phototherapy Lamp 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.

The Phototherapy Lamp is suitable for use in all establishments, including domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.

Warning - The Phototherapy Lamp should not be used adjacent to or stacked with other equipment. If adjacent or stacked use is necessary, the Phototherapy Lamp should be observed to verify normal operation in the configuration in which it will be used. IEC 60601-1-2, Table 202 Electromagnetic Immunity The Phototherapy Lamp is intended for use in the electromagnetic environment specified below. The customer or the user of the Phototherapy Lamp should assure that it is used in such environment. Immunity Tests

IEC 60601 test level

Compliance level

Electromagnetic environment guidance

Electrostatic Discharge (ESD) IEC 61000-4-2

± 6 kV contact ± 8 kV air

± 6 kV contact ± 8 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 IEC 61000-4-4

± 2 kV for power supply lines ± 1 kV for input/output lines

± 2 kV for power supply lines ± 1 kV for input/output lines

Mains power quality should be that of a typical commercial or hospital environment.

Surge IEC 61000-4-5

± 1 kV differential mode ± 2 kV common mode

± 1 kV differential mode ± 2 kV common mode

Mains power quality should be that of a typical commercial or hospital environment.

Voltage dips, short interruptions and voltage variations on power supply input lines IEC 61000-4-11

<5 % UT (>95 % dip in UT) for 0.5 cycle 40 % UT (60 % dip in UT) for 5 cycles 70 % UT (30 % dip in UT) for 25 cycles <5 % UT (>95 % dip in UT) for 5 sec

<5 % UT (>95 % dip in UT) for 0.5 cycle 40 % UT (60 % dip in UT) for 5 cycles 70 % UT (30 % dip in UT) for 25 cycles <5 % UT (>95 % dip in UT) for 5 sec

Mains power quality should be that of a typical commercial or hospital environment. If the user of the Phototherapy Lamp requires continued operation during power mains interruptions, it is recommended that the Phototherapy Lamp be powered from am uninterruptible power supply or a battery.

Power frequency (50/60 Hz) magnetic field IEC 61000-4-8

3 A/m

3 A/m

Power frequency magnetic fields should be at levels of a typical commercial or hospital environment.

NOTE UT is the a.c. mains voltage prior to application of the test level.

Seite

62

IEC 60601-1-2, Table 204 Electromagnetic Immunity The Phototherapy Lamp is intended for use in the electromagnetic environment specified below. The customer or the user of the Phototherapy Lamp should assure that it is used in such environment. Immunity Tests

IEC 60601 test level

Compliance level

Electromagnetic environment - guidance Portable and mobile RF communications equipment should be used no closer to any part of the Phototherapy Lamp, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Recommended separation distance

Conducted RF

3 Vrms

IEC 61000-4-6

150 kHz to 80 MHz

3 Vrms

d = 1.2 P d = 1.2 P 80 MHz to 800 MHz d = 2.3 P

Radiated RF IEC 61000-4-6

3 V/m 80 MHz to 2.5 GHz

3 V/m

800 MHz to 2.5 GHz where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in meters (m) Field strengths from fixed RF transmitters, as determined by a an electromagnetic site survey , should be less than the b 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 affected by absorption and reflection from structures, objects and people. a

Field strengths from fixed RF 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 Phototherapy Lamp is used exceeds the applicable RF compliance level above, the Phototherapy Lamp should be observed to verify normal operation. If abnormal operation is observed, additional measures may be necessary, such as reorienting or relocating the Phototherapy Lamp. b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m IEC 60601-1-2, Table 206 Recommended separation distance between portable and mobile RF communications equipment and the Phototherapy Lamp The Phototherapy Lamp is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the Phototherapy Lamp can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the Phototherapy Lamp 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

80 MHz to 800 MHz

800 MHz to 2.5 GHz

d = 1.2 P

d = 1.2 P

d = 2.3 P

0.01

0.12

0.12

0.23

0.1

0.38

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 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 affected by absorption and reflection from structures, objects and people.

Seite

63

Canada Medela, Inc. 4090B Sladeview Crescent, Unit 2 Mississauga, Ontario Canada, L5L 5Y5 Phone +1 905 608 7272 Fax +1 905 608 8720 e-mail [email protected] www.medela.ca France Medela France Sarl 14, rue de la Butte Cordière 91154 Etampes cedex Phone +33 (0)1 69 16 10 30 Fax +33 (0)1 69 16 10 32 e-mail [email protected] www.medela.fr Germany Medela Medizintechnik GmbH & Co. Handels KG Postfach 1148 85378 Eching Phone +49 (0)89 31 97 59-0 Fax +49 (0)89 31 97 59 99 e-mail [email protected] www.medela.de Italy Medela Italia Srl Via Stelloni 39/O 40010 Sala Bolognese Phone +39 051 681 52 76 Fax +39 051 681 52 77 e-mail [email protected] www.medela.it Japan Medela K.K. Fuji Chuo Building 5F 2-1-7, Shintomi Chuo-ku, Tokyo 104-0041 Phone +81 3 3553 3571 Fax +81 3 3553 3573 e-mail [email protected] www.medela.co.jp

Russia OOO Medela Fersmana Street 5A 117312 Moskau Phone +7 (095) 980 6194 Fax +7 (095) 718 1700 e-mail [email protected] www.medela-russia.ru Spain Medela España c/ Manuel Fernández Márquez, 49 08918 Badalona Phone +34 93 320 59 69 Fax +34 93 320 55 31 e-mail [email protected] www.medela.es Sweden Medela Medical AB Box 7266 187 14 Täby Phone +46 (0)8 630 09 40 Fax +46 (0)8 630 09 48 e-mail [email protected] www.medela.se United Kingdom Medela UK Ltd. Huntsman Drive Northbank Industrial Park Irlam, Manchester M44 5EGw Phone +44 870 950 5994 Fax +44 870 389 2233 e-mail [email protected] www.medela.co.uk USA Medela, Inc. P.O. Box 660 McHenry, IL. 60051-0660 Phone +1 815 363 1166 Fax +1 815 363 1246 e-mail [email protected] www.medela.com

Netherlands/Belgium Medela Benelux BV De Steenbok 12 5215 ME 's-Hertogenbosch Phone +31 73 690 40 40 Fax +31 73 690 40 44 e-mail [email protected] e-mail [email protected] www.medela.nl www.medela.be

Switzerland & International Sales Medela AG, Medical Technology Lättichstrasse 4b 6341 Baar/Switzerland Phone +41 (0)41 769 51 51 Fax +41 (0)41 769 51 00 e-mail [email protected] www.medela.ch¨

Seite

64