Gima PRIMALED SO, Operator'S Manual

Page 1: ...ing the structure to the wall tube 8 2 3 Connecting up the electrical system 8 2 4 Handpiece fitting 9 2 5 First switch on 9 2 6 Check the result of Product installation and testing before use 9 3 Importance of personal safety 9 3 1 Intended use 9 3 2 Environmental conditions 9 3 3 Safety conditions secondary effects 10 3 4 Controls to be performed every time before the lamp is used 10 4 Descripti...

Page 2: ... Italian reference shall always be made to the Italian edition of this operator s manual 1 General information THE EM Electro Medical DEVICE to which this manual refers is a LAMP for diagnosis or observation For ease of description in this manual this EM EQUIPMENT will be called Product This manual is an integral part of the Product as indicated by European Directives 93 42 EEC and 2007 47 EC Alwa...

Page 3: ...cations provided by the insert manufacturers and shown below for your better information Anchor tie rod do mm t mm hs mm l mm Mt Nm SW mm x mm HSL 3 G M 8 20 12 80 60 98 25 13 20 do Nominal drill bit diameter Mt Closing bending moment t Minimum drilling depth Sw Key opening hs Minimum insertion depth Anchor tie rod length x Fastening height 1 Using the paper template provided and attached to this ...

Page 4: ...tances in the environment separate the various internal component parts such as iron aluminium plastic and electrical material and dispose of these through authorized channels so as to ensure correct recycling 1 2 Packaging transport storage and characteristics of installation premises Boxes containing the Product together with operator s manual Transport is made by GIMA or any road hauler as long...

Page 5: ...IT 12 09 2017 Rev 3 Page 5 of 20 Do not stack packaging Weight of packaging Protect from rain Weight of packaging I ON power Weight of packaging Stand By O OFF power L Line lead connection point N Neutral lead connection point ...

Page 6: ...sis Part 2 General requirements for basic safety and essential performance Collateral Standard Electromagnetic disturbances Requirements and tests Classification with reference to article 9 and Annex IX of Directives 93 42 EEC and 2007 47 EC DURATION Short term duration Annex IX Par 1 Definitions art 1 subsection 1 1 DESCRIPTION Non invasive medical device Annex IX Par 1 Definitions art 1 subsecti...

Page 7: ... not above 40 of the net value of the product as indicated on the buyer s invoice GIMA s liability is expressly ruled out for indirect damages or consequential damages including cases of the lamp not being used deriving from the supply 8 This warranty certificate replaces legal warranties for faults and non conformities and rules out any other possible liability of GIMA originating from the suppli...

Page 8: ...to the desired size in relation to the height of the room make the cut on the side of the tube 3 opposite to that bearing the fastening holes 4 of the horizontal arm To define the correct length of the tube use the table shown the suggested distance between floor and lamp headpiece is 200cm Drawing 56 Fit the anchor tube 1 until it is up against the hub of the ceiling plate 2 keeping the cut side ...

Page 9: ... M4 screws which sustain the horizontal arm are tight 6 Check the Product earth connection and make sure the clamps are well tightened 7 Make sure movement mechanisms are working properly 8 After switch on the Product must emit light from the headpiece Installer s stamp and signature 3 Importance of personal safety 3 1 Intended use The Product has been designed to light up the area of the patient ...

Page 10: ...uate intensity The flexible arm remains in the selected position without falling 4 Description and operation 4 1 Description The Product locally lights up the patient s body thanks to 9 LEDs focalized by means of specific lenses 3 non focalized LEDs are also fitted to permit using a courtesy or reading light Positioning the light beam is made easy thanks to the articulated arm and is done manually...

Page 11: ...use disinfectants which are chlorine and halogen free to prevent the plastic parts becoming fragile use only disinfectants with low alcohol content dose the disinfectants so no liquids penetrate inside the lamp elements and into the support arm system Clean the Product with a damp but not wet cloth The Product is best disinfected every time before use To clean the lamp the support need not be remo...

Page 12: ...uses If any one of the fuses is damaged replace it as indicated in section 6 6 If the product still does not work contact the assistance service 2 The Product does not remain in position See par 10 If after adjustment the product still fails to remain in position contact the GIMA after sales service 3 The light flickers Contact the after sales service 4 The light beam is not focalised Contact the ...

Page 13: ...ption Order code Fuse T1AH 250V 5x20 Z400208 Sterilisable grip Z100848 Drawing 190 To access the fuses loosen the 3 dowels 1 of the ring 2 Remove the bar cover 3 by pulling downwards Drawing 191 Remove the fuse carrier 6 from the terminal board and replace the fuse 7 making sure it is replaced with another of the same type ...

Page 14: ...mance Distribution of minimum and adequate lighting luminous flux emitted by the ME equipment does not vary by more than 20 during use and the colour temperature and the colour rendering index are stable and are within the range 3000K 6700K and 85 100 respectively Limitation of energy in the operating field UV irradiance for wavelengths below 400 nm does not exceed 10 W m2 and the total irradiance...

Page 15: ...Operator s Manual MO080 IT 12 09 2017 Rev 3 Page 15 of 20 8 Wiring diagram ...

Page 16: ... 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 RF Emissions CISPR 11 Class A The Product is suitable for use in all establishments other than domestic and may be used in domestic establishments and those directly connected to the public low voltage power supply network that supplies ...

Page 17: ...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 of UT 60 dip in UT For 5 cycles 70 of 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 of UT 60 dip in UT For 5 cycles 70 of UT 30 dip in UT For 25 cycles 5 UT 95 dip in...

Page 18: ...tion distance d 1 2 P 150 KHz to 80 MHz d 1 2 P 80 MHz to 800 MHz d 2 3 P 80 MHz to 2 5 GHz where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacture and d is the recommended separation distance in meters m Field strengths from fixed transmitters as determined by an electromagnetic site survey should be less than the compliance leave in each ...

Page 19: ...of transmitter W Separation distance according to frequency of transmitter m 150 kHz to 80 MHz d 1 2 P 80 MHz to 800 MHz d 1 2 P 800 MHz to 2 5 GHz d 2 3 P 0 01 0 12 0 12 0 24 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 ...

Page 20: ... the small moving arms ROTATION JOINTS ADJUSTMENT PROCEDURE Using the Allen key adjust the screw alongside the joint in question Turn clockwise to increase the force of the clutch and stiffen movement Turn anti clockwise to reduce the force of the clutch and loosen movement After making adjustment movement should be smooth and uniform The clutches on the horizontal arm can also be adjusted To adju...

Page 21: ...Drawing code Rev Data 052 1 2 3 ...

Page 22: ...Drawing code Rev Data 053 1 2 3 ...

Page 23: ...Drawing code Rev Data 054 2 1 3 4 ...

Page 24: ... B 2 Tube length list mm Tabella lunghezze tubo mm L H mm L mm 2440 200 2450 210 2500 260 2550 310 2600 360 2650 410 2700 460 2750 510 2800 560 2850 610 2900 660 2950 710 3000 760 3050 810 3100 860 3150 910 3200 960 1 1 3 4 2000 L H ...

Page 25: ...Drawing code Rev Data 056 2 1 3 4 5 ...

Page 26: ...Drawing code Rev Data 057 3 1 2 ...

Page 27: ...Drawing code Rev Data 058 2 1 3 4 ...

Page 28: ...Drawing code Rev Data 1 2 7 3 4 5 6 153 ...

Page 29: ...Drawing code Rev Data 190 1 2 3 4 5 6 8 7 ...

Page 30: ...Drawing code Rev Data 191 1 2 4 5 3 6 7 ...

Page 31: ......

Page 32: ......