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Mach LED 500DF

 

Dr. Mach

Lamps and Engineering

 

59190002 

Edition 05 

15.09.2014 / Bak We  page 

25/26

 

Table 4 – Guidance and manufacturer´s declaration – electromagnetic immunity –  

for EQUIPMENT and SYSTEM that are not LIFE-SUPPORTING

  

 

 

Guidance and manufacturer´s declaration – electromagnetic immunity 

The MACH LED 500DF is intended for use in the electromagnetic environment specified below. The customer 
or the user of the MACH LED 500DF should assure that it is used in such an environment. 

Immunity test 

IEC 60601 test level 

Compliance level 

Electromagnetic 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 LED 500DF, 
including cables, than the recommended separation dis-
tance calculated from the equation applicable to the fre-
quency of the transmitter. 
 

Recommended separation distance 

P

d

17

,

1

 

 
 
 
 
 
 
 
 

P

d

17

,

1

   

80 MHz to 800 MHz 

 

P

d

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 manufactur-
er and 

d

 is the recommended separation distance in metres 

(m).

b

 

 
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 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 LED 500DF is used exceeds the applicable RF compliance level above, the MACH LED 500DF should be observed to 
verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the 
MACH LED 500DF. 
 

b

      Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m. 

  

 

 

Summary of Contents for Mach LED 500DF

Page 1: ...09 2014 Bak We page 1 26 Operating instructions MACH LED 500DF 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 info dr mach de Design with central reflector available against surcharge ...

Page 2: ...m 2 4 Overview of the lamp functions page 10 2 5 Adjusting the light intensity page 11 2 6 Positioning page 12 2 7 Danger of collision while positioning the lights page 13 3 Cleaning page 14 3 1 Sterilisable handle page 14 3 2 Lamp housing dispersing lens and support system page 16 4 Maintenance page 17 4 1 Maintenance work page 17 4 2 Adjustments at the lamp head page 18 5 Data page 19 5 1 Techni...

Page 3: ... adjustable light colour a life span of minimum 40 000 hours and an almost non existent heat development in the surgeon s head area and in the wound field The advantages already provided by Dr Mach s light technology with halogen and gas discharge lamps have been maintained natural colour reproduction exact illumination of the wound field and easy positioning of the light head All information quot...

Page 4: ...wed The manufacturer cannot be made liable for personal or material damages if the light is operated inexpediently or incorrectly or used for purposes other than those for which it is intended The light is to be dismantled from the spring arm in reverse order to its assembly This may only be carried out after the spring arm has been adjusted in height at horizontal position since the arm is under ...

Page 5: ...ions mentioned in the mounting instructions and user manuals from Ondal company This symbol means possible hazard caused by electric current Please observe also the safety remarks and the hazard specifications mentioned in the mounting instructions and user manuals from Ondal company This symbol refers to important mounting indications useful information and operation hints Temperature range for t...

Page 6: ...d notes used on the device This symbol indicates to observe the user manual Alternating current Bulb Fuse Protective conductor Temperature range for transport and storage Indication for disposal Serial number of the product Article number of the product Address of manufacturer distributor of the product ...

Page 7: ...N 60601 2 41 which is not fail safe when used as a single light The light is used in medical rooms groups 0 1 and 2 according to DIN VDE 0100 710 This light system can be added to the ceiling mounted suspension system supporting the horizon tal arms and spring arms The light system is operated by a keypad on the lamp The OT lamp MACH LED 500 is available in following versions Duo Focus OT lamp DF ...

Page 8: ...y turning the sterilisable handle 2 1 2 Focusing The DF model offers a second additional facility to further adjust the illuminated field to an extra small or extra large size depending on the specific requirements by focusing NOTE This feature is activated by turning the ring at the top of the sterilisable handle 2 1 3 Light intensity control The OT lamp models LED 500DF offer a standard feature ...

Page 9: ...an bow The lights LED 500DF are switched ON OFF with the touch button 1 at the key pad of the lamp 2 3 Adjusting the illuminated area by merging the light fields and focusing Duo Focus system All lamp models LED 500DF offer the feature of merging the light fields and focussing Merging of light fields is activated by turning the sterilisable handle 2 Focusing is activated by turning the ring 3 at t...

Page 10: ...lds overlap This feature is activated by turning the sterilisable handle 1 By focusing you can further adjust the illuminated field to an extra small or extra large size depending on the specific requirements This feature is activated by turning the ring 2 at the top of the sterilisable handle Always activate merging of light fields first by turning the handle 1 then activate focusing when necessa...

Page 11: ... the desired light intensity before the operation At these models the adjustment is done by the key pad at the cardan bow The intensity can be infinitely adjusted between 50 and 100 Press push button 2 to increase the light intensity and press push button 3 to reduce the light intensity The light intensity set is shown by LED display 1 2 3 1 ...

Page 12: ...ation Use the sterile handle for positioning during the operation This handle can be removed for steriliza tion Remark Position the light only with the handle or the special designed parts on the light housing The working distance of the lamps is 0 6m to 1 5m Two or more lamps can be used for an intensive illumination of large operation fields It is also possible to illuminate two operation fields...

Page 13: ... 59190002 Edition 05 15 09 2014 Bak We page 13 26 2 7 Danger of collision while positioning the lights During positioning eventual collisions between the lights spring arms and other devices must be avoided Cover parts can get loose and fall down ...

Page 14: ...e used for cleaning disinfection and that the validated parameters are complied with in every cycle In addition the hospital clinic hygiene regulations must be observed Remark The requirements of the national commitees standards and directives for hygienics and disinfection must be observed Cleaning disinfection Cleaning and disinfection must be carried out immediately after use A mechanised proce...

Page 15: ...the re rinse and draining times will depend on the respective objects being washed therein 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 o...

Page 16: ...e handle sleeve like shown in the photo The stamping in the photo shows the number 12 which stands for the year 2012 3 2 Lamp housing protective disk and support system The OT lamp MACH LED 500DF has a high quality surface which can be cleaned with conventional cleaning agents The protective disks 2 are made of a high quality plastic Pay attention to the following during clean ing Never wipe over ...

Page 17: ...n During all maintenance work the light must be disconnected from mains and secured against resetting 4 1 Maintenance work The following maintenance work tests has have to be done check on defects in paint work check on fissures at plastic parts check on deformation of the suspension check on loosened parts check the connection between light and carrying system check and grease the securing segmen...

Page 18: ...justments at the lamp head The fine adjustment for handling the lamps can be carried out at points 2 and 3 To adjust the brakes use a screw driver with appropriate size If you cannot adjust the brakes at points 2 and 3 anymore as tight as necessary you will have to replace them 2 3 Upper housing part ...

Page 19: ... shadowers 47 49 Illumination depth 20 550 mm 1380 mm Illumination depth 60 290 mm 310 mm Colour rendering index Ra 95 95 Colour rendering index R9 90 90 Radiation in field in a distance of 1 meter 563 W m 562 W m 2 Max radiation in field in a distance of 1 meter 563 W m 562 W m 2 Focussable size of the light field 15 30 cm 15 30 cm Colour temperature Kelvin 4500 K 4500 K Temperature increase in h...

Page 20: ...output voltage 28V DC In case there is a switch over relay needed for an emergency power supply on site this switch over relay must be ordered separately at Dr Mach In case of a power supply provided by the customer the following points must be observed The OT light works with 24V 30V DC direct voltage The direct voltage provided by the hospital must have a maximum undulation of 5 A higher voltage...

Page 21: ...tmospheric humidity 30 75 Air pressure 700 hPa 1060 hPa in case of higher temperatures please contact us Transport storage Min Max Temperature 10 C 50 C Relative atmospheric humidity 20 90 Air pressure 700 hPa 1060 hPa References on the package Temperature range for transport and storage Atmospheric humidity for transport and storage Air pressure for transport and storage ...

Page 22: ...hapter 16 of the European standard EN 60601 1 2006 must be applied and eventually it has to be checked if the requirements are met The light must be tested according to EN 62353 at commissioning The polarity is very important for the installation of the light In case the light does not function after installation the polarity must be checked at the secondary side of the power supply 6 CE mark The ...

Page 23: ...er s declaration electromagnetic emission The MACH LED 500DF is intended for use in the electromagnetic environment specified below The customer or the user of the MACH LED 500DF should assure that it is used in such an environment Emissions test Compliance Electromagnetic environment guidance RF emissions CISPR 11 Group 1 The Mach LED 500DF uses RF energy only for its internal function There fore...

Page 24: ...l 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 U...

Page 25: ...transmitter manufactur er 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...

Page 26: ...s recommended below according to the maximum output power of the communications equipment Separation distance according to frequency of transmitter m Rated maximum output of transmitter W 150 kHz to 80 MHz P d 17 1 80 MHz to 800 MHz P d 17 1 800 MHz to 2 5 GHz P d 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 maximu...

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