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Mach M2 Dr. Mach Lamps and Engineering 59120002 Edition 07 06.02.2010 / Bak page 1/27 Instructions for use MACH M2 WITH BACKUP HALOGEN BULB Mach M2 ceiling, wall and stand lamp Mach M2 F ceiling, wall and stand lamp Dr. Mach GmbH u. Co. KG, Floßmannstrasse 28, D-85560 Ebersberg Tel.: +49 (0)8092 2093 0, Fax +49 (0)8092 2093 50 Internet: www.dr-mach.com , E-Mail: [email protected]

MACH M2 WITH BACKUP HALOGEN BULB Mach M2 Dr. Mach Lamps and Engineering 59120002 Edition 07 06.02.2010 / Bak page 6/27 2.4 Adjusting the light field (only Mach M2 F and Mach M2 F/H)

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Page 1: MACH M2 WITH BACKUP HALOGEN BULB Mach M2 Dr. Mach Lamps and Engineering 59120002 Edition 07 06.02.2010 / Bak page 6/27 2.4 Adjusting the light field (only Mach M2 F and Mach M2 F/H)

Mach M2 Dr. Mach Lamps and Engineering

59120002 Edition 07 06.02.2010 / Bak page 1/27

Instructions for use

MACH M2 WITH BACKUP HALOGEN BULB

Mach M2 ceiling, wall and stand lamp Mach M2 F ceiling, wall and stand lamp

Dr. Mach GmbH u. Co. KG, Floßmannstrasse 28, D-85560 Ebersber g Tel.: +49 (0)8092 2093 0, Fax +49 (0)8092 2093 50

Internet: www.dr-mach.com , E-Mail: [email protected]

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Mach M2 Dr. Mach Lamps and Engineering

59120002 Edition 07 06.02.2010 / Bak page 2/27

List of contents

1. Safety instructions ....................................................................................page 4 2. Operating the lamp MACH M2..................................................................page 5

2.1 Brief description of the lamp...............................................................page 5 2.2 Turning the lamp ON/OFF..................................................................page 5 2.3 Positioning..........................................................................................page 5 2.4 Adjusting the light field .......................................................................page 6 2.5 Electronic light intensity control ..........................................................page 6 2.6 Operation mode with backup halogen bulb ........................................page 7

3. Cleaning ...................................................................................................page 7

3.1 Sterilisable handle ..............................................................................page 7 3.2 Lamp housing and splinter protection disk .........................................page 9

4. Maintenance .............................................................................................page 10

4.1 Adjusting the mobility .........................................................................page 10 4.1.1 Settings at the lamp head............................................................page 10

4.2 Testing the change-over function of the bulb......................................page 10 4.3 Changing of spare parts .....................................................................page 11

4.3.1 Changing the halogen bulbs........................................................page 11 4.3.2 Changing the filter disk................................................................page 14 4.3.3 Changing the splinter protection disk ..........................................page 16

5. Data..........................................................................................................page 19

5.1 Technical data ....................................................................................page 19 5.2 Electrical data.....................................................................................page 20 5.3 Environmental conditions ...................................................................page 20 5.4 General remarks.................................................................................page 20

6. CE-mark ...................................................................................................page 20 7. Disposal....................................................................................................page 21 8. Spare parts ...............................................................................................page 22

8.1 Mach M2 F .........................................................................................page 22 8.2 Mach M2.............................................................................................page 23

9. Spare parts list..........................................................................................page 24 9. Electromagnetic compatibility ...................................................................page 25

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Mach M2 Dr. Mach Lamps and Engineering

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Dear customer! Congratulations for acquiring our new lamp MACH M2 . With this lighting system you profit from a whole range of new developments, based on 50 years of experience in the production of operating and doctor lights. The lighting system is characterised by a previously unreceivable general colour rendition value of Ra=96. In other words, the colours are reproduced naturally and in high contrast . The wound area is shown in a comfortable light . The different reds of a wound area can now be recognised very precisely. For the doctor or surgeon this means a considerable improvement in the recognition of details in the wound area . The R96 lighting system uses computer-optimised cold-light filters that reduce both the un-wanted build-up of heat in the head area and the he at radiated on the illuminated wound area to a minimum . All information quoted here relates only to the illuminants. Details of ceiling, wall and stand in-stallation can be found in the mounting instructions.

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Mach M2 Dr. Mach Lamps and Engineering

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1. Safety instructions

Pay attention to the directions for use when handli ng the lamp.

WARNING:

This device has not been designed for use in potent ially explosive areas. According to the Medical Device Regulation the lamp is classified under class I.

Store the OT-lamp in its package for at least 24 ho urs in the respective roombefore mounting, in order to eqal temperature differences.

Please read the instructions for use carefully to m ake the most of your lighting sys-tem and to avoid any damages to the device. The lamps may only be repaired and special assembly work may only be carried out on the reflector or sockets by ourselves or a compa ny that has been expressly authorised by us. The manufacturer can only be made responsible for t he safety of the lamp if repairs and alterations are carried out by the manufacturer himself or a company that guar-anteed to observe the safety regulations. The manufacturer cannot be made liable for personal or material damages if the lamp is operated inexpediently or incorrectly or us ed for purposes other than those for which it is intended. All lamps are equipped with heat protection filter. It is not allowed to use the lamps without this fil ter! Do not remove the heat protec-tion filter, otherwise risk of burn! The lamp is to be dismatled from the spring arm in reverse order to its assembly and is to be done only after securing the spring ar m by a second person. Make sure that the lamp is in perfect working order before every use. Attention, external transformer! The lamp works only with an external transformer. The external transformer must be tested and validat ed according to IEC 60601-1, otherwise it is not allowed to use it with Dr. Mach lamps.

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2. Operating the lamp MACH M2

2.1 Brief description of the lamp The lamp MACH M2 is available in following versions: - Mach M2, examination and small surgery lamp with fix-focus; - Mach M2 F, examination and small surgery lamp with focusable light field; - Mach M2 H, examination and small surgery lamp with fix-focus and electronic light intensity; - Mach M2 F/H, examination and small surgery lamp with focusable light field and electronic light inten-

sity The lamps are equipped with two IRC bulbs. This feature enables an uninterruptible work continuation in case of the failure of one bulb. In case one IRC bulb fails, the second bulb takes its place (activated by a swivel mechanism) and contin-ues burning.

2.2 Turning the lamp ON/OFF The lamp is turned ON and OFF by the rocker switch 1.

2.3 Positioning Use the sterilisable handle 2 or the handle 3 at the lamp housing the position the lamp. Use the sterilisable handle 2 for positioning during treatment. This handle can be removed for sterilisa-tion.

1

2

3

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2.4 Adjusting the light field (only Mach M2 F and Mach M2 F/H) The lamps Mach M2 F and Mach M2 F/H have a focusing function. That means, the diameter of the light field can either be enlarged or bundled to a smaller area, depending on the circumstances. For adjusting the light field size turn the handle 2 at the lamp (see figure).

2.5 Electronic light intensity control (only Mach M2 H and M2 F/H) The H- lamp models are equipped with electronic light intensity control. You can adjust the light intensity between 50% and 100%, according to your requirements. Select the desired light intensity before the opera-tion. At these models the adjustment is done by the keypad at the cardan bow. Press push button 2 to increase the light intensity and press push button 3 to reduce the light inten-sity. The light intensity set is shown by LED-display 1.

2

2 3

1

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2.6 Operation mode with backup

halogen bulb The light models are equipped with two halogen bulbs. In case that one halogen bulb fails, the second bulb swings in the position of the first bulb and takes over the task of the defective bulb. During the operation with the backup halogen bulb the LED array 1 is blinking. Please replace the defective halogen bulb as soon as possible. When the lamp is turned ON the next time, it will change automatically to the operation mode with main halogen bulb.

3. Cleaning

3.1 Sterilisable handle At delivery the lamp is equipped with the handle 2. The handle is removable and sterilisable. Before using the first time and before every use the handle sleeve must be cleaned, disinfected and sterilised. The handle must be removed for sterilisation: • To remove press the lock 4 and pull off the ster-

ilisable handle 2 while keeping the lock pressed. • To attach, push on and slightly twist the handle

until the lock 4 engages securely. Handles often become unsterile during an operation. Therefore always keep aditional handles available for exchange.

4

2

1

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Cleaning / disinfection and sterilisation Basics Efficient cleaning / disinfection is an essential requirement for effective sterilisation of the handle. Within the scope of responsibility for the sterility of the products it should be noted that only sufficiently validated equipment and product specific processes are used for cleaning / disinfection and that the vali-dated parameters are complied with in every cycle. In addition, the hospital / clinic hygiene regulations must be observed. Cleaning / disinfection Cleaning and disinfection must be carried out immediately after use. A mechanised process (disinfector) should be used for cleaning / disinfection. The efficiency of the proc-ess used must be recognised and validated in principle (e.g. listed under disinfectants and disinfection procedures tested and recognised by Robert-Koch-Institute / DGHM). When using other procedures (e.g. a manual procedure), proof and process efficiency in principle must be provided within the scope of validation. Proof in principle of the suitability of the handles for efficient cleaning / disinfection was provided using a cyclic cleaning system (Netsch-Bellmed T-600-IUDT/AN, programme 2 for small parts; code B). It is not allowed to use agents / disinfectants, which contain the following substances, as these may cause changes in the material:

- High-concentration organic and inorganic acids - Chlorinated hydrocarbons - 2-ethoxyethanol

When cleaning / disinfecting, the following procedures must be followed:

Process Time (sec.)

Zone 1 Pre-rinse, external, cold, 10 – 15°C 45 Washing, acidic, external 35°C 120 Draining time 10 Re-rinse, external approx. 80°C *10 Draining time *15 Re-rinse, external approx. 80°C *15 Draining time 15 Zone 2 Washing, alkaline, external, 93°C 135 Draining time 10 Re-rinse, external, acidic, 90°C 10 Draining time 15 Re-rinse, external 90°C 15 Draining time 15 Zone 3 Drying, external 100 – 120°C 200 Zone 4 Drying, external 100 – 120°C 200 Door open / close & transport 60 (sluice discharge) Cycle time overall ca. 290 ≈ 5 minutes * When occupying the disinfection zone (washing zone 2), the re-rinse and draining times will depend on

the respective objects being washed therein!

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Sterilisation Only previously cleaned and disinfected handles may be sterilised. The handles are placed in a suitable sterilisation pack (one-way sterilisation pack, e.g. foil / paper sterili-sation bags, single or double pack) in accordance with DIN EN 868 / ISO 11607 for steam sterilisation and then sterilised. Use only the sterilisation procedure listed below for sterilisation. Other sterilisation procedures (e.g. ethyl-ene oxide, formaldehyde and low-temperature plasma sterilisation) are not permissible.

Steam sterilisation procedure Validated in accordance with DIN EN 554/ISO 11134 Maximum sterilisation temperature 134°C

Proof in principle of the handles’ suitability for effective sterilisation was provided using a fractional vac-uum process (Euroselectomat 666 by MMM Münchner Medizin Mechanik GmbH, sterilising temperature 134°C, holding time 7 min.) Inspection / durability The handles should be inspected for damage and changed before re-use, if required. The handles may be cleaned / disinfected, sterilised and re-used for a maximum of 1000 times. If the handles are re-used more than 1000 times, then this will be the responsibility of the hospital / clinic.

3.2 Lamp head, splinter protection disk The lamp has a high-quality surface. The surface can be cleaned with conventional cleaning agents. The splinter protection disk 5 is made of a high-quality plastic. Pay attention to the following during cleaning: • Always clean the splinter protection disk 5

with a wet cloth (never clean with a dry cloth!). • Only use disinfectants with less than 20% al-

cohol .

Wipe the splinter protection disk 5 after cleaning with an antistatic, non-fluffy cloth.

Alc. ≤≤≤≤ 20 %

5

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4. Maintenance 4.1 Adjusting the mobility

The lamp MACH M2 is supplied with brakes on the suspension fixture and on the lamp housing. Adjust these brakes, if necessary, after installation. If it is difficult to move the lamp, or if it does not keep its set position, the brake forces should be adjusted. Service and a check of the lamp should be made every two years. In order to keep the system easy-running through-out its life span, we recommend that the hinges should be greased avery two years with acid-free grease. Attention: Before dismounting the lamp, make sure that somebody is holding the spring arm, to avoid its bouncing up. 4.1.1 Adjustments at the lamp head Adjusting the mobility in the lamp joint 6 is not necessary. In case the mobility in the lamp joint 7 is too easy-going or too heavy-going, the brake screw 8 must be adjusted with an appropriate screw driver.

4.2 Testing the change- over function of the bulb We recommend to test the change-over function of the bulb every year. For testing press the two buttons for the light inten-sity control at the same time. The LED’s B start to blink. Remark: In case you notice that the LED’s B are blinking in every day use, you should replace the main bulb as soon as possible.

6 7

8

A

B

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4.3 Changing of spare parts 4.3.1 Changing the halogen bulbs Dr. Mach uses special IRC bulbs as illuminants. Only original Dr. Mach replacement bulbs may be use d. The use of other bulbs can lead to a considerable reduction of the light power and increase in the thermal load. The IRC bulbs have a service life of approx. 1000 hours.

• Turn off the lamp. ATTENTION: Parts of the housing and the ha-logen bulb may be very hot immediately after use.

• Turn the lamp, so the light outlet points to the ceiling.

• Turn the screw 9 anticlockwise with an appro-priate screw driver.

Remark: In case there is no screw driver available, you can use a coin.

• By turning the screw 9 anticlockwise, the re-taining ring 10 turns clockwise off the lower housing part.

• Turn the screw 9 until the two marking arrows on the ring of the light and the lower housing part of the lamp match as shown in the figure.

9

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• Then remove the retaining ring 10 by pulling it

upwards.

• Now you can see the open reflector 11 in front

of you. ATTENTION: Do not touch the inner surface of the reflector, otherwise this surface can be damaged.

9

10

11

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• Tilt the shadower 12 off-center as shown in the

figure on the left, until it snaps in in the provided groove.

• Pull the halogen bulb 13 carefully off its socket.

ATTENTION: Never touch new halogen bulbs with your fingers. Always use the original pack-aging or a clean cloth. • Carefully insert the halogen bulb (22,8V, 80W)

in the socket. • Tilt the shadower 12 in its original position.

• Mount the retaining ring 10 in reverse order

(anticlockwise rotation). For mounting position the retaining ring 10 so that the toothed wheel segment 14 of the ring and the toothed wheel 7 in the lower housing part work into each other.

• Fix the retaining ring by turning the screw 9 clockwise.

• Check the function of the new halogen bulb.

13

12

10 14

15

9

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4.3.2 Changing the filter disk The filter disk mounted between reflector and splin-ter protection disk prevents a damaging heating of the illuminated area. ATTENTION! It is not allowed to use the lamp without this filter. Always place the filter disk on a soft, non-scratching base to preserve its surface. • Turn off the lamp.

ATTENTION: Parts of the housing and the ha-logen bulb may be very hot immediately after use.

• Turn the lamp, so the light outlet points to the ceiling.

• Turn the screw 9 anticlockwise with an appro-priate screw driver.

Remark: In case there is no screw driver available, you can use a coin.

• By turning the screw 9 anticlockwise, the re-taining ring 10 turns clockwise off the lower housing part.

• Turn the screw 9 until the two marking arrows on the ring of the light and the lower housing part of the lamp match as shown in the figure.

9

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• Then remove the retaining ring 10 by pulling it

upwards.

• The filter disk 16 is held by six retainers 17 ,

which are fixed with six recessed head screws. • Loosen the screws at three adjacent retainers

17.

• Lift the filter disk 16 carefully and pull it off the

other three retainers. • Mount the new filter disk in reverse order.

ATTENTION: Only use filter disks, that have been cleaned properly (see chapter 3.2).

9

10

16

17

16

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• Mount the retaining ring 10 in reverse order

(anticlockwise rotation). For mounting position the retaining ring 10 so that the toothed wheel segment 14 of the ring and the toothed wheel 7 in the lower housing part work into each other.

• Fix the retaining ring by turning the screw 9 clockwise.

4.3.3 Changing the dispersing lens The dispersing lens is made of a high-quality plastic. In case the dispersing lens looses its optical charac-teristics, this can reduce the luminous intensity and the light quality provided. It may be necessary to exchange the dispersing lens. Always place the dispersing lens on a soft, non-scratching base to preserve its surface. • Turn off the lamp.

ATTENTION: Parts of the housing and the ha-logen bulb may be very hot immediately after use.

• Turn the lamp, so the light outlet points to the ceiling.

• Turn the screw 9 anticlockwise with an appropri-ate screw driver.

Remark: In case there is no screw driver available, you can use a coin.

10 14

15

9

9

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• By turning the screw 9 anticlockwise, the re-taining ring 10 turns clockwise off the lower housing part.

• Turn the screw 9 until the two marking arrows on the ring of the light and the lower housing part of the lamp match as shown in the figure.

• Remove the retaining ring 10 by pulling it up-

wards.

9

10

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• Loosen the six screws 18 and remove them. • Lift the filter disk 17 off the six retainers 16 .

Always place the filter disk on a soft, non-scratching base to preserve its surface.

• Remove the six retainers 16 . • Remove the ring 20 . • Remove the splinter protection disk 19 .

Always place the splinter protection disk on a soft, non-scratching base to preserve its surface.

• Mount the new splinter protection disk 19 . ATTENTION: Only use splinter protection disks, that have been cleaned properly (see chapter 3.2) .

• Mount the ring 20 , the retainers 16 and the filter disk 17 in reverse order and fix the six re-tainers with the screws 18 .

• Mount the retaining ring 10 in reverse order

(anticlockwise rotation). For mounting position the retaining ring 10 so that the toothed wheel segment 14 of the ring and the toothed wheel 7 in the lower housing part work into each other.

• Fix the retaining ring by turning the screw 9 clockwise.

18

17

19

10 14

15

9

16

20

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5. Data

5.1 Technical data

Mach M2 F Mach M2

Central light intensity at a distance of 1 meter

40.000 – 80.000 Lux 60.000 Lux

Light field diameter d10 160 mm 170 mm

Light field diameter d50 90 mm 110 mm

Light intensity with one shadower 125 Lux 45 Lux

Light intensity with two shadowers 47.000 Lux 35.000 Lux

Light intensity on the ground of a normed tube

79.200 Lux 59.600 Lux

Light intensity on the ground of a normed tube with one shadower

85 Lux 30 Lux

Light intensity on the ground of a normed tube with two shadowers 46.000 Lux 34.500 Lux

Illumination depth 1600 mm 1600 mm

Colour rendering index Ra at 4300 Kelvin 96 96

Colour rendering index R9 at 4300 Kelvin > 90 > 90

Focusable light field size 140 – 240 mm 180 mm Fixfocus

Colour temperature (Kelvin) 4300 4300

Radiation intensity in field 130 W/m2 130 W/m2

Temperature increase in head area 2 °C 2 °C

Electronic light intensiyt control Option Option

Total power consumption 80 VA 80 VA

Number of bulbs: Halogen 22V 80W

2 2

Working distance 700 – 1400 mm 700 – 1400 mm

Height adjustment 1300 mm 1300 mm

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5.2 Electrical data

Mach M2 F / Mach M2

Power consumption 80 W

Voltage AC/DC 22,8 V

Current 3,5 A

Halogen bulb 2x 22 V / 80 W IRC

Frequency 50/60 Hz

Degree of protection Type B

Class of protection I.

5.3 Environmental conditions

Operation Min. Max.

Temperature +10°C +40°C Relative athmospheric humidity 30 % 75 % Air pressure 700 hPa 1060 hPa

Transport / storage Min. Max.

Temperature -10°C +50°C Relative athmospheric humidity 20 % 90 % Air pressure 700 hPa 1060 hPa 5.4 General remarks When installing a lamp, its fail-safety must be guaranteed according to DIN VDE 0100-710 (former DIN VDE 0107). Attention! Beginning with January 15th 2010 the formerly known verification document is no longer delivered with the light. This document can be requ ested when needed. Please provide the serial number of respective light. The light must still be tested at commissioning.

Protective conductor

6. CE-mark

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The products Mach M2 comply with the standards 93/42/EEC for medical products of the European Community’s Council. Dr. Mach applies the standard EN 60601-2-41. Dr. Mach GmbH is certified according to DIN EN ISO 13485:2003.

7. Disposal

The lamp doesn’t contain any dangerous goods. The components of the OT-lamp should be properly disposed at the end of its shelf-life. Make sure, that the materials are carefully separated. The components should be disposed according to the contained materials.

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8. Spare parts

8.1 Mach M2 F

12

1

2

6

7

3

4

5

8

9

10 11

13

14

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8.2 Mach M2

12

1

2

7

8

3

4

5

6

9

10 11

13

14

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9. Spare parts list

Item Qty. Name EDVNO Remark

1 1 Upper housing part 12011001 with sealing cord

2 1 Sterilisable handle 21150002

3 6 Screw DIN7985-HM3x12-Ni 65152037

4 1 Conversion filter D284 Califlex Eco 67390208

5 6 Retainer 27021206

6 1 Ring 27021205

7 1 Splinter protection disk 27021201

8 1 Retaining ring 27021203

9 2 Socket GY 6.35 67320011

10 2 Halogen bulb 22V 80W IRC 67100105

11 1 Shadower 26063001

12 1 ON/OFF switch 67340004

13 1 Sliding contact with cable 12102001

14 1 Keypad 12117002

15 1 Dimmer board for light intensity control 72000035 Not shown

Remark: The parts 3,4,5,6,7 and 8 can also be ordered as a premounted complete unit (No. 27021001, retainig ring) .

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10. Electromagnetic compatibility Table 201 – Guidance and manufacturer´s declaration – electromagnetic emission – for all EQUIPMENT AND SYSTEMS (see 6.8.3.201 a) 3))

1 Guidance and manufacturer´s declaration – electroma gnetic emission

2 The MACH M2 / M2 F is intended for use in the electromagnetic environment specified below. The customer or the user of the MACH M2 / M2 F should assure that it is used in such an environment.

3 Emissions test Compliance Electromagnetic environment - guidance

7 Harmonic emissions IEC 61000-3-2

Class C

8 Voltage fluctuations / flicker emissions IEC 61000-3-3

Complies

The MACH M2 / M2 F is suitable for use in all establishments, including domestic establishments and those directly con-nected to the public low-voltage power supply network that supplies buildings used for domestic purposes.

12 RF emissions CISPR 15

Complies The MACH M2 / M2 F is not suitable for interconnection with other equipment.

Table 202 – Guidance and manufacturer's declaration – electromagnetic immunity – for all EQUIPMENT and SYSTEMS (see 6.8.3.201 a) 6))

Guidance and manufacturer´s declaration – electromagnetic immunity The MACH M2 / M2 F is intended for use in the electromagnetic environment specified below. The customer or the user of the MACH M2 / M2 F should assure that it is used in such an environment.

Immunity test 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 not applicable

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 MACH M2 / M2 F requires continued operation during power mains interruptions, it is recommended that the MACH M2 / M2 F be powered from an uninterruptible power supply or a battery.

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

3 A/m 30 A/m Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment.

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

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Table 204 – Guidance and manufacturer´s declaration – electromagnetic immunity –

for EQUIPMENT and SYSTEM that are not LIFE-SUPPORTING (see 6.8.3.201 b))

Guidance and manufacturer´s declaration – electroma gnetic immunity The MACH M2 / M2 F is intended for use in the electromagnetic environment specified below. The customer or the user of the MACH M2 / M2 F should assure that it is used in such an environment. Immunity test IEC 60601 test level Compliance level Electromagnet ic environment - guidance Conducted RF IEC 61000-4-6 Radiated RF IEC 61000-4-3

3 V 150 kHz to 80 MHz

3 V/m 80 MHz to 2,5 GHz

3 V 3 V/m

Portable and mobile RF communications equipment should be used no closer to any part of the MACH M2 / M2 F, including cables, than the recommended separation dis-tance calculated from the equation applicable to the fre-quency of the transmitter. Recommended separation distance

Pd 17,1=

Pd 17,1= 80 MHz to 800 MHz

Pd 34,2= 800 MHz to 2,5 GHz

where p is the maximum output power rating of the trans-mitter in watts (W) according to the transmitter manufac-turer and d is the recommended separation distance in metres (m).b

Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey,a should be less than the compliance level in each frequency range.b

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 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 envi-ronment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the MACH M2 / M2 F is used exceeds the applicable RF compliance level above, the MACH M2 / M2 F should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the MACH M2 / M2 F. b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.

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Table 206 – Recommended separation distances betwee n portable and mobile

RF communications equipment and the EQUIPMENT or SYSTEM - for EQUIPMENT and SYSTEMS that are not LIFE-SUPPORTING (see 6.8.3.201 b))

Recommended separation distances between portable and mobile RF communications equipment and the MACH M2 / M2 F

The MACH M2 / M2 F is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The cus-tomer or the user of the MACH M2 / M2 F can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the MACH LED 5MC/SC as recommended below, according to the maximum output power of the communications equipment

Separation distance according to frequency of trans mitter m

Rated maximum output of transmitter

W

150 kHz to 80 MHz

Pd 17,1=

80 MHz to 800 MHz

Pd 17,1=

800 MHz to 2,5 GHz

Pd 34,2=

0,01 0,12 0,12 0,23

0,1 0,37 0,37 0,74

1 1,17 1,17 2,33

10 3,69 3,69 7,38

100 11,67 11,67 23,33

For transmitters rated at a maximum output power no t listed above the recommended separation distance d in metres (m) can be estimated using the equation applicable to the f requency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the trans mitter 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.