94/RPR/073 ALLEGATO 4
Contents
1. Operator s manual MU_021_GB 13 12 13 Rev 0 Pag 6 di 25 5 4 Yearlyinspectionsbythekeeper 16 Ee EE 16 6 Adjusiments 16 6 1 Setting the rocker arm EEN 16 6 2 Adjustimentofthebrakingforce 17 6 3 Troubleshooting zeg hee alindi aadaki eh 17 6 4 Routine une e nee ee 18 7 Technical 0313 22 0 000101010111 titeraria 19 8 EMC le E 21 RIMSA MU_021_GB 13 12 13 Operator s manual Rev 0 Pag 7 di 25 Product Personnel Personal safety Adjustments Cleaning Importance of manual 1 Important information for the user The ME Medical Electrical EQUIPMENT to which this manual refers is a LAMP for Operating Theatre or SYSTEM of LAMPS for Operating Theatre For ease of description this ME EQUIPMENT will be referred to in this manual with the name of Product 1 1 User qualification The Product and these operating instructions are intended for use by medical personnel and qualified technicians working in hospitals and medical surgeries who have acquired working skills by undergoing medical training and who are in possession of necessary authorisation where required Importance of personal safety Before using the Product read the safety precautions in paragraphs 2 1 3 4 and 3 5 The operations described in Chapter 6 Adjustments must be performed by a qualified technician2. MU_021_GB 13 12 13 RIMSA Operator s manual Rev 0 Pag 1 di 25 Operator s manual lamp for operating theatre TRIS LED Single Ceiling Double Ceiling TRIS LED TRIS LED Mobile Wall RIMSA MU_021_GB 13 12 13 Operator s manual Rev 0 Pag 2 di 25 Introduction Mark C Conformity Validity of manual Customer service Copyright Dear user You are kindiy invited to read this manual carefully before proceeding to use the Product in order to safeguard yourself and other people from any injuries This appliance is a Class 1 medical device pursuant to European Directives on medical devices MDD 93 42 EEC Annex IX and 2007 47 EC The manufacturer declares that this product is in compliance with Annex essential requirements of Directive 93 42 EEC and certifies such conformity by affixing the CE mark The Product is classified in risk group 1 according to IEC 62471 standard Photobiological Safety of Lamps This operator s manual refers to the following Products e TRIS LED single ceiling version e TRIS LED double ceiling version TRIS LED TRIS LED e TRIS LED mobile version e TRIS LED wall version The customer service is at your disposal in case of Product details information concerning its use identification of spare parts being required and for any other queries you might have concerning the appliance for ordering spares and for matters relating
3. INTERRUPT THE POWER SUPPLY BEFORE PERFORMING THESE OPERATIONS Once a year Make sure the line voltage is correct Make sure 24V are reaching the board Once a year Check the condition of the lamp paint Make sure there are no paint pieces that could fall on the operating field Description Order code Sterilizable handle 2200518 RIMSA Operator s manual MU_021_GB 13 12 13 Rev 0 Pag 19 di 25 7 Technical data Technical data on light TRIS LED TRIS LED TRIS LED Illumination E at a distance of 1 m 10 Lux 10 100 000 100 000 100 000 Colour temperature K 5 4 300 Colour rendering index Ra 96 96 Ro gt 90 No Leds No 28 No 28 No 28 Focus Manual Light field diameter adjustable from to cm 26 38 26 38 26 38 Diameter of the light field dso mm 120 120 120 Diameter of the light field do mm 240 240 240 Illumination depth L1 L2 at 60 cm 82 82 82 Maximum irradiation W m 280 280 280 Irradiation Illumination ImW m ix 2 79 2 79 2 79 Maximum irradiation in the UV W m 0 001 0 001 0 001 Focusing by handle Manual Data on electrical connection Primary alternating voltage Volt ac 100 240 Secondary continue voltage Volt dc 24 24 Frequency Hz 50 60 Power Absorbed VA 70 70 70 Light source n 28 LEDs n 28 n
4. 28 LEDs Led diode light source duration h this datum can vary according to a power voltage higher 50 000 the specified one voltage peaks and the frequency of RIMSA Operator s manual MU_021_GB 13 12 13 Rev 0 Pag 20 di 25 Light field adjustable from to cm 26 38 General data Colour RAL 9003 Directive 2007 47 EC Standard IEC 60601 2 41 Electrical safety class Class Protection against direct and indirect contacts B type device Dimensions Lamp body diameter cm 40 40 0 Light emission surface cm 200 200 200 Scialytic ceiling single floor wall ceiling double TRIS 35 32 27 55 LED TRIS LED lamp weight Kg Certificates CE Complying with directive 93 42 EEC and 2007 47 EC All lighting values are subject to a tolerance of 6 due to manufacturing and metrological reasons RIMSA Operator s manual MU_021_GB 13 12 13 Rev 0 Pag 21 di 25 8 EMC compliance The Product has been tested in accordance to EN60601 1 2 to ensure proper electromagnetic compatibility Portable and mobile RF communications equipment can affect the Product Other products used in the vicinity of Product should also comply with this standard The Product is intended for use in the electromagnetic environment specified below The customer or the user of the Product should assure that these are used in
5. Managing Director MU_021_GB 13 12 13 Operator s manual Rev 0 Pag 5 di 25 Table of Contents 1 Important information for the user 7 It 5 610191116311011 O 7 1 2 Precautionsforsafeapplianceoperation 8 2 Precautions for the appliance operator 8 2 1 Technical safety specifications EE 8 2 2 Personnel training obligation sss 8 2 3 Warranty and liabilities en 9 2 4 Structural changes or variations i 9 2 5 Disposal after use 9 3 Importance of personal safety 9 3 1 Intended USE sto A a een t ae 9 3 2 Environmental 600001116008 einen ili sieiiisisinir 10 3 3 Use in combination with other medical products 10 3 4 Technicalsafetyconditions 11 3 5 Other safety conditions secondaryeffecits 11 3 6 Graphic symbols used in this Manual 12 3 7 Other graphic symbols used on the device 12 4 Lamp description and operation 13 4 1 Description of the Product eil lle ei 13 4 2 Description of the 006130 13 5 Cleaninganddisinfection 14 5 1 Cleaning the Product unsere al 14 9 2 DIS NM ea 14 5 3 Sterilizing the 1300016068 un 15
6. for use in an electromagnetic environment in which radiated RF disturbances are controlled The customer or the user of the Product can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and the Product as recommended below according to the maximum output power of the communications equipment Rated maximum output Separation distance according to frequency of transmitter power of transmitter W 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2 5 GHz d 1 2P d 1 2P d 2 3P 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 din meters m can be estimated using the equation applicable to the frequency of the transmitter where Pis 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 an people Operator s manual MU_021_GB 13 12 13 Rev 0 Pag 25 di 25 F T2A 100Vac F T1A 230Vac LI FASE
7. such an environment IEC 61000 3 3 Emissions test Compliance Electromagnetic environment guidance The Product uses RF energy only for its internal RF emissions Gwini function Therefore its RF emissions are very CISPR 11 p low and are not likely to cause any interference in nearby electronic equipment agi The Product is suitable for use in all a Class A establishments other than domestic and may be used in domestic establishments and those directly connected to the public low voltage H eci power supply network that supplies buildings u nn Class A used for domestic purposes provided the IEC 61000 3 2 SC following warning is heeded Warning This equipment system is intended for use by healthcare professionals only This Voltage fluctuations equipment system may cause radio interference flicker emissions Compliance or may disrupt the operation of nearby equipment lt may be necessary to take mitigation measures such as re orienting or relocating the Product or shielding the location RIMSA Operator s manual MU_021_GB 13 12 13 Rev 0 Pag 22 di 25 Immunity test IEC 60601 1 2 test level Compliance level Electromagnetic environment guidance Electrostatic 6 kV contact 6 kV contact Floors should be wood discharge 8 kV air 8 kV air concrete or ceramic tile ESD If floors are covered with IEC 61000 4 2 synthetic mat
8. to assistance and warranty e RIMSA P LONGONI SRL e Via Monterosa 18 e 1 20831 Seregno MB e Tel 39 0362 325 709 e Fax 39 0362 328 559 e Email info rimsa it The contents of this Manual may be amended by Rimsa without prior notice or any further obligations in order to make changes and improvements The reproduction including partial or translation of any part of this manual is forbidden without the written permission of RIMSA RIMSA MU_021_GB 13 12 13 Operator s manual wn Rosa Rightto make changes Rimsa reserves the right to change cancel or otherwise amend the data Translations contained in this document at any time and for any reason without prior notice inasmuch as Rimsa is constantly seeking new solutions which lead to product evolution Rimsa therefore reserves the right to make changes to the supplied Product in terms of shape fittings technology and performances With regard to translations into languages other than Italian reference shall always be made to the Italian edition of this operator s manual MU_021_GB 13 12 13 Rev 0 Pag 4 di 25 RIMSA Operator s manual Manufacturer s declaration of conformity CE The company RIMSA P LONGONI S r l Via Monterosa 18 20 22 20831 SEREGNO MB ITALY Declares under its own responsibility that the Product Medical lighting device for surgical and diagnosis use TRIS LED AP
9. PLICARE ETICHETTA made by RIMSA P LONGONI S r l complies with Annex VII of Directive 93 42 EEC dated 14 05 1993 and subsequent amendments including Directive 2007 47 EC dated 05 09 2007 and the following standards e JEC 60601 1 Part 1 General requirements for basic safety and essential performance Part 2 Particular requirements for basic safety and essential performance of surgical luminaires and luminaires for diagnosis e IEC 60601 1 2 Part 1 General requirements for basic safety and essential performance Collateral standard Electromagnetic compatibility Requierements and tests e IEC 60601 2 41 Classification with reference to article 9 and Annex IX of Directives 93 42 EEC and 2007 47 EC DURATION Short term Par 1 Definitions art 1 sub section 1 1 annex IX DESCRIPTION Non invasive medical device Par 1 Definitions art 1 sub section 1 2 annex IX Active medical device Par 1 Definitions art 1 sub section 1 4 annex IX CLASS Par 3 Classification art 1 sub section 1 1 Rule 1 annex IX e Technical reference file Code RIM FT002 e The conformity assessment is developed in reference to article 11 of the 93 42 EEC Directive and 2007 47 EC e The RIMSA Quality System conforms to the UNI EN ISO 9001 and UNI EN ISO 13485 regulations and is certified by the CSQ certified CSQ n 9120 RMS1 and 9124 RMS2 CD Name Paolo Longoni P LONGI gd Position
10. _ PHASE POWER SUPPLY POWER LINE 100 240Vac L2 NEUTRO NEUTRAL Ac IN 100 240V Dc OUT 24V I bipolar switch PAGINA PAGE MOLO TME SCHEMA GENERALE TRIS LED SOFFITTO NS EE 0 POWER SUPPLY SCHEME LAMP TRIS LED CEILING ED_185 L1 FASE PHASE L2 NEUTRO NEUTRAL C network z UPOLA o 14 12 13 palo E I bipolar switch FT2A F TIA 230Vac POWER SUPPLY F T2A 100Vac Ac IN 100 240V Dc OUT 24V F TIA 230Vac L n 7 x 4 LED i T T SCHEMA GENERALE TRIS LED PI 2 3 POWER SUPPLY SCHEME LAMP TRIS LED PI DIS N DRW N ED_185 I bipolar switch F T2A u F TIA 230Vac L1 FASE_ PHASE POWER SUPPLY F T2A 100vac Ac IN 100 240V De OUT 24V F TIA 230Vac ee L n 7 x 4 LED CU POLA DIS N DRW N PAGINA PAGE SCHEMA GENERALE TRIS LED PA POWER SUPPLY SCHEME LAMP TRIS LED PA en 3 3 MAIN LAMP POWER LINE 100 240Vac L1 FASE PHASE L2 NEUTRO NEUTRAL n 7 x 4 LED CUPOLA lo 14 12 13 we POWER SUPPLY Ac IN 100 240V Dc OUT 24V bipolar switch PAGINA PAGE VIN SCHEMA GENERALE TRIS LED SOFFITTO NEN 142 POWER SUPPLY SCHEME LAMP TRIS LED CEILING ED_185 SATELLITE LAMP L1 FASE PHASE POWER LINE 100 240Vac L2 NEUTRO NEUTRAL n 7 x 4 LED CUPOLA o 14 12 13 palo E PAGINA PAGE 2 2 POWER SUPPLY Ac IN 100 240V D
11. an immediately hazardous situation which could result in death or serious injuries CAUTION indicates a potentially hazardous situation that could result in death or serious injuries IMPORTANT indicates a potentially hazardous situation which could result in moderate or light injuries The following triangular symbol together with the explanation alongside indicates the type of hazard to be dealt with a damped arm during installation Electric shock Mechanical hazard from sprung masses quick break of 3 7 Other graphic symbols used on the device Below are the symbols to be found on the Product 1 B Type device Indicates the level of protection against direct and indirect contact Graphic symbol proving the EC marking of the product A Symbol indicating the manufacture date month and year Fuses used by the device MU_021_GB 13 12 13 Operator s manual Rev 0 Pag 13 di 25 Version See drawing 151 See drawing 30 See drawing 32 See drawing 79 Light field 4 Lamp description and operation 4 1 Description of the Product The Product is available in different versions mobile version wall version ceiling single version ceiling double version scialytic lamp system MOBILE version wheel base 1 power supply unit 2 base cover 3 switching on base 4 vertical stem 5 oscillating arm 6 fork 7 lamp head 8 switch
12. c OUT 24V TITOLO TITLE bipolar switch SCHEMA GENERALE TRIS LED SOFFITTO POWER SUPPLY SCHEME LAMP TRIS LED CEILING DIS N DRW N ED_185
13. c force of the spring is insufficient turn the lever downwards and load the spring MU_021_GB 13 12 13 Operator s manual Rev 0 Pag 17 di 25 See drawing 33 Horizontal arm brakes If the swing arm continues to lift up this means the elastic force of the spring is too high turn the lever upwards and release the spring After making adjustments return the covering to its original position 6 2 Adjustment of the braking force The brakes are set during installation As for all the mechanic parts brakes also are subject to wear and tear If the lamp body does not automatically keep the position in which it is put it is necessary to adjust the braking force by acting on the screws of the brakes Use a cut suitable screwdriver to increase the braking force rotating clockwise the screws 4 and 5 of the horizontal arm Fork brakes To increase the head braking force rotate clockwise the dowels 6 and 7 of the brake with an Allen key 6 3 Troubleshooting No Problem Solution Make sure the plate fitted on the wall wall is perfectly flat that the stem is flat on the base 4 The Product does not remain in mobile and that the tube secured to the ceiling position ceiling is level Further tighten the brakes on the joints so as to increase friction 2 The Product fails to work Make sure fuses have been fitted inside the terminal board Make sure the electrical connector
14. d do not clean it disinfect it with liquids Leave the lamp body to cool down Only clean the lamp body when it is cold Clean with appropriate detergent with low alkaline content and chlorine free Do not use abrasive products petrol paint thinners alkaline detergents acids containing alcohol or aldehydes Dose the detergents so no liquids penetrate into the lamp bodies and into the support arm system Clean the Product with a damp but not wet cloth Non respecting the instructions of cleaning and disinfection could cause paint detachment with possible fall in the patient area early deterioration of plastic parts and glass opacification 5 2 Disinfecting CAUTION Electric shock hazard CAUTION Switch the Product off by means of the operating theatre main switch and make sure it cannot be switched back on Protect the Product against water spray and do not clean it disinfect it with liquids Leave the lamp body to cool down Only disinfect the lamp body when it is cold Disinfectants can contain substances which are harmful for the health only use disinfectants in accordance with the rules on hygiene established by the hospital RIMSA MU_021_GB 13 12 13 Operator s manual Rev 0 Pag 15 di 25 IMPORTANT The Product operator must comply with the rules established by the national commission for hygiene and disinfection To prevent damaging parts in stainless steel or alumi
15. d to assistance repairs structural changes and additional accessories only original Rimsa spare parts are used 3 5 Other safety conditions secondary effects Do not direct the light source into the patient s and or operator s eyes Obligation to adequately protect the patient s eyes Failure to follow such precautions could cause glare and potential damage to the retina Never place and or hang anything on the Product Unless this precaution is taken positioning will not be reliable and the danger exists of such objects falling in the operating area Never hang on the Product with the body weight of a person Unless this precaution is taken mechanical parts of the Product could be damaged Never cover the head of the Product during operation Failure to comply could prevent heat exchange with the environment and the Product could overheat Avoid knocking the rocker arms and Product head A violent knock could damage the Product and pieces of paint could chip off and fall onto the operating field in the patient area RIMSA Operator s manual MU_021_GB 13 12 13 Rev 0 Pag 12 di 25 3 6 Graphic symbols used in this manual In these operating instructions and on the lamp itself important indications are marked by means of symbols and notice words Notice words such as HAZARD CAUTION or IMPORTANT indicate the classification of the risk of suffering injuries HAZARD indicates
16. e Product is not suitable for use in explosion risk areas The Product is not suitable for use in the presence of inflammable mixtures of anesthetics with air oxygen or NO laughing gas During operation the ambient temperature must be between 10 C and 40 Relative humidity must be between 30 and 75 Atmospheric pressure must be between 700 and 1060hPa 3 3 Use in combination with other medical products the Product can be equipped with appliances of other manufacturers Refer to the operating instructions for such appliances Only fit medical devices e g LCD monitors bearing the CE mark RIMSA MU_021_GB 13 12 13 Operator s manual Rev 0 Pag 11 di 25 Safe fastening Wiring systems Authorised personnel Correct assembly and start up Original spares Optical safety Incorrect use Covering the heads Knocks 3 4 Technical safety conditions The safe use and proper operation of the Product is ensured if The lamp is safely fastened to the ceiling wall from a static viewpoint and a static stability test exists The wiring systems of the premises involved are in compliance with applicable local regulations Changes to the lamp or maintenance jobs are performed by personnel trained by Rimsa or by a professional technician The Product has been installed following currently valid installation instructions and has been started up by a professional installer With regar
17. erial the relative humidity should be at least 30 Electrical fast 2kV 2 kV Mains power quality should be transient burst IEC for power supply unit for power supply that of a typical commercial or 61000 4 4 lines hospital environment 1 KV for input output lines 1 kV for input output lines Surge 1 kV 1 kV Mains power quality should be IEC 61000 4 5 differential mode differential mode that of a typical commercial or hospital environment kV 2 kV common mode common mode Voltage dips short lt 5 Ur lt 5 Ur Mains power quality should be interruptions and gt 95 dip in Ur gt 95 dip in Ur that of a typical commercial or voltage variations on For 0 5 cycle For 0 5 cycle hospital environment If the power supply input user of the Product requires lines 40 of Uy 40 of Uy continued operation during IEC 61000 4 11 60 dip in Uy 60 dip in Uy power mains interruptions it is For 5 cycles For 5 cycles recommended that the Product be powered from an 70 of Ur 70 of Ur uninterruptible power supply 30 dip in Ur For 25 cycles 30 dip in Ur For 25 cycles or battery lt 5 Ur lt 5 Ur gt 95 dip in Ur gt 95 dip in Ur For 5 sec For 5 sec Power frequency 3 A m 3 A m Power freguency magnetic 50 60Hz field IEC 61000 4 8 magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environmen
18. ing on cupola UO 9 sterilizable handle 10 power supply plug 11 WALL version wall plate 1 power supply unit 2 horizontal arm 3 oscillating arm 4 fork 5 lamp head 6 switching on cupola I O 7 sterilizable handle 8 power supply plug 9 CEILING SINGLE version ceiling cover 1 ceiling anchorage tube 2 horizontal arm 3 oscillating arm 4 fork 5 lamp head 6 switching on cupola I O 7 sterilizable handle 8 CEILING DOUBLE version ceiling cover 1 ceiling anchorage tube 2 horizontal arm 3 oscillating arm 4 fork 5 lamp head 6 switching on cupola I O 7 sterilizable handle 8 4 2 Description of the operation The function control panel is applied to the cupola of the Product Such panel allows to turn the lamp on and off by means of the switch I O 1 o C The mechanical regulation of the light field takes place through the rotation of the sterilizable handpiece By rotating in a direction rather than the opposite one the light field in the illuminated area patient area is enlarged or reduced MU_021_GB 13 12 13 Operator s manual Rev 0 Pag 14 di 25 5 Cleaning and disinfection 5 1 Cleaning the Product CAUTION Electric shock hazard IMPORTANT IMPORTANT Switch the Product off by means of the operating theatre main switch and make sure it cannot be switched back on Protect the Product against water spray an
19. itrary changes Only use original Rimsa spare parts Disposal at the end of life cycle Use in compliance with standards Field of work 2 3 Warranty and liabilities Rimsa disclaims all liability as regards unreliable Product operation in the following cases assembly changes and repairs not being made by a technician who has attended a training course on the Product organized by the manufacturer or by a professional technician the Product not being used for the purposes for which it was intended in compliance with the operating rules and instructions 2 4 Structural changes or variations For safety reasons no arbitrary structural changes or variations to the Product are acceptable In case of changes or transformations of this kind the manufacturer s Product warranty shall be invalidated The manufacturer thus disclaims all liability for any damage or injuries caused by any arbitrary structural modifications or variations made or the use of non original spare parts The use of parts not supplied by Rimsa or its dealers shall invalidate the warranty 2 5 Disposal after use The used Product contains valuable materials which can be recycled Dispose of the used Product in an environment friendly way and in compliance with applicable national directives on waste disposal 3 Importance of personal safety 3 1 Intended use The Product is made to light up the area occupied by the patient undergoing surgery or obse
20. n side downwards Do not exceed a sterilization temperature of 134 C MU_021_GB 13 12 13 Operator s manual Rev 0 Pag 16 di 25 Avoid the handpieces coming into contact with other objects during the disinfection process Each Product over time is subject to a certain amount of wear Product safety and operation must therefore be checked during inspection and maintenance intervals 5 4 Yearly inspections by the keeper ATTENTION Keep to the yearly inspection schedules and inspect the product according to IEC 62353 standard 5 5 5 5 CAUTION Unsuitable repairs See drawing 33 The Product must only be opened and repaired by a technician who has attended a course on the Product organised by the manufacturer or by a qualified technician in possession of the necessary technical skills 6 Adjustments 6 1 Setting the rocker arm The Product is sold already balanced and does not require further adjustment In the event of the swinging arm with spring balancing becoming stiff or loose over time mechanical intervention is possible by regulating the compression of the internal spring Loosen the two stop dowels 1 which secure the cover 2 and move this forward Fit a pin 3 with max diameter of 7 mm in the holes of the ring nut and turn in the direction indicated by the arrows to increase decrease the load on the spring If the swing arm drops this means the elasti
21. nium only 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 bodies and into the support arm system Clean the Product with a damp but not wet cloth 5 3 Sterilizing the handpieces CAUTION Hazard for the patient Replace the handpieces as soon as these become cracked or deformed as these could fall in the wound area The Product operator must comply with the rules of the national commission for hygiene and disinfection Handpiece fitting removal press the handpiece safety key and remove the handpiece insert the handpiece up fast and turn it until it fastens on and rotation is blocked Cleaning disinfecting and sterilizing the handpiece The handpieces are made of plastic material resistant to heat and knocks PPSU They can be cleaned with a lightly alkaline detergent free of active chlorine To disinfect the handpieces we suggest using alcohol or aldehyde based products The disinfectants must be approved by the manufacturer for use on polyphenylsulfone PPSU Before sterilizing rinse the handpieces The handpieces can withstand about 300 steam sterilization cycles as follows steam sterilization at 121 C 1 3bar from 25 to 30 minutes or steam sterilization at 134 C 2 3 bar for 4 minutes Position the handpieces straight with ope
22. not replace the obligation to instruct the user to carry out operations important for safety operating using and looking after the Product The Product is made according to the current state of the art and its operation is safe as long as it is used in compliance with all operating instructions and safety precautions Use of the Product can nevertheless be dangerous especially if it is used by unqualified or inexpert persons or in an incorrect way without abiding by the safety precautions contained in this operator s manual or in a way not in compliance with intended use The Product is only designed to be used for the purposes indicated in this operator s manual Any other use could cause mortal danger and or hazards for the Product and the other material assets of the operator 2 Precautions for the appliance operator 2 1 Technical safety specifications The Product cleaning and disinfecting operations described in Chapter 5 must only be performed by duly trained personnel The inspection and maintenance operations described in Chapter 6 must only be performed by professional technical personnel 2 2 Personnel training obligation Instruct personnel according to the operating instructions as regards controlling cleaning and looking after the lamp The operator must provide such personnel with written instructions based on this manual MU_021_GB 13 12 13 Operator s manual Rev 0 Pag 9 di 25 Arb
23. of the Product operator in accordance with the safety rules and precautions indicated in this operator s manual Product cleaning can only be done by duly trained personnel This manual is an integral part of the Product according to the provisions of the European Directives 93 42 EEC and 2007 47 EC Always keep this operator s manual close to the Product so as to be able to refer to it in case of doubts relating to lamp use safety matters and other important information Never transfer the Product to another user or to other premises without its being accompanied by this operator s manual This manual must always accompany the Product These operating instructions must always be easily accessible to any Product user You are invited to carefully read this operator s manual before using the Product This way you can make best use of Product potential and protect yourself and others from any injuries RIMSA MU_021_GB 13 12 13 Operator s manual Rev 0 Pag 8 di 25 Correct installation Safety provisions To only be used in compliance with intended use Cleaning personnel Servicing personnel Instructing users 1 2 Precautions for safe appliance operation This operators manual is only valid after the correct installation of the Product made in compliance with the valid installation instructions and with the correct startup by a professional installer This operator s manual does
24. rvation and has been designed for use in operating theatres or medical surgeries The Product correctly lights up the field of work from a distance of about 70 140 cm from the point of operation RIMSA MU_021_GB 13 12 13 Operator s manual Rev 0 Pag 10 di 25 Definition Definition Undesired effects caused by superimposition of light fields Single lamp In compliance with the IEC60601 2 41 standard a single lamp TRIS LED is a secondary scialytic lamp for surgery and can only be used in operations where the interruption of lighting does not cause risks for the patient System of operating lamps In compliance with the IEC60601 2 41 standard a system of lamps TRIS LED TRIS LED made up of several lamp units can be used to locally light up the patient s body without any limitation It is also suitable for continuous function It enables the surgeon to operate also in the most difficult conditions of visibility It is intended to make treatment and diagnosis possible and to be used in operating theatres If the light fields of several lamp units are superimposed there will be an increase in heat in the patient area with consequent dehydration of tissues and above all in the case of prolonged operation and reduced blood supply considerable damage to tissues If reduced blood supply or the start of tissue dehydration occurs reduce the light intensity 3 2 Environmental conditions Th
25. s are fitted Make sure there is power voltage in the lamp head 18 26VDC Check the specifications of the fitted fuses T1A primary and T6 3A secondary for 230Vac supply 3 The fuse continues to burn out T2A primary and T6 3A secondary for 100Vac supply T2A primary and T10A secondary for battery 230Vac supply T4A primary and T10A secondary for battery 100Vac supply The light flickers and produces a stroboscopic effect Contact the after sales service light fields The light beam on the operating field 5 is not focalised defective meeting of Contact the after sales service 6 The Product does not switch on Check the supply power voltage and check the fuses RIMSA Operator s manual MU_021_GB 13 12 13 Rev 0 Pag 18 di 25 6 4 Routine maintenance no Period Job Every 6 months Inspect all the lamp joints and make sure they do not squeak If they do add white grease to the clutches involved If the Product does not maintain the position adjust the clutches To determine which clutches to adjust see point 6 2 Once a year Make sure the Tiges retention screws are tightened properly Also check the 6 horizontal arm retention screws and the 3 swing arm screws If these are not properly fastened adequately tighten Once a year Check the integrity of the power cables If they are not proceed to correctly tighten
26. t NOTE U is the a c main voltage prior to application of the test level RIMSA Operator s manual MU_021_GB 13 12 13 Rev 0 Pag 23 di 25 Immunity test IEC 60601 test level Compliance level Electromagnetic environment guidance Conducted RF IEC 61000 4 6 Radiated RF IEC 61000 4 3 3 Vrms 150 kHz to 80 MHz 3 V m 80 MHZ to 2 5GHz 3 Vrms 3 V m Portable and mobile RF communications equipment should be used no closer to any part of the Product included cables than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter Recommended separation distance 1 2VP 150 KHz to 80 MHz 1 2 P 80 MHz to 800 MHz 23NP 80 MHz to 2 5 GHz d d d where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacture and dis 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 frequency range Interference may occur in the vicinity of equipment marked with the following symbol d N A Operators manual MU_021_GB 13 12 13 Rev 0 Pag 24 di 25 Recommended separation distance between portable an mobile RF communications equipment and the Product The Product is intended
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