Rimsa PentaLED 12 User Manual & Installation Guide
Contents
1. Color rendering index Ra Diameter of the light field dso mm 85 Diameter of the light field dio mm 140 Illumination depth mm 1500 Maximum irradiation W m 119 Irradiation Illumination mW m ix 2 38 Maximum irradiation in the UV W m 0 001 Focus by handle No Data on electrical connection Primary alternating voltage Volt ac 100 240 Frequency Hz 50 60 Absorbed power VA 40 Light source N 12 Led x 2W LED light source duration h this datum can vary according to voltage peaks and the frequency of use 20 009 Light intensity control 50 100 General data Color RAL 9003 Directive 93 42 EEC included 2007 47 EC Standard EN 60601 2 41 MIU_010_GB 14 02 12 NA Installation and RIMS IN operator s manual Rev 4 Page 34 of 34 Electrical safety class Class Protection against direct and indirect contacts B type device Dimensions Lamp body diameter cm 30 Diameter of the poly elliptical reflector cm 5 5 Light emission surface cm 285 a mobile ceiling wall ceiling double lamp weight 18 13 11 20 Certificates CE Complying with directive 93 42 EEC included 2007 47 EC Notes gt 164 184 Y Disegno di dima per l esecuzione dei 6 fori dis 1 1 drawing to be used to do 6 holes dwg n 11 Formato A3 D A3 format D code 112. 28 rescindi 28 7 3 Sterilizing the handpieces 29 7 4 Yearly inspections by the operator 30 8 Adjusimenits ui 30 8 1 Adjustment of the swing arm 30 8 2 Adjustment of the braking force 31 8 3 1 0 0129 31 8 4 Routine maintenance eene 32 8 5 Spare part 5 32 9 Technical 43le 2 2 em 33 RIMSA Installation and MIU 010 GB 14 02 12 operator s manual Rev 4 Page 8 of 34 Product CAUTION CAUTION CAUTION CAUTION CAUTION 1 General information IMPORTANT The ME Medical Electrical EQUIPMENT to which this manual refers is a LAMP for Operating Theatre or SYSTEM of LAMPS for Operating Theatre of the PENTALED series and D series For easier description such ME EQUIPMENT will be indicated in this manual with the name of Product This manual is an integral part of the Product as required by European directive 93 42 EEC and 2007 47 EC Always keep this installation manual close to the lamp The Product is not suitable for use in explosion risk areas The Product is not suitable for use in the presence of inflammable mixtures of anaesthetics with air oxygen or NO laughing gas RIMSA d
3. 19 4 2 1 Installation of stand power supply and covering 19 4 2 2 Installation of the heeling arm and head 20 4 3 Wall version Product installation 20 4 3 1 Installation of wall plate and power supply 20 4 3 2 Structure installation 20 4 4 Ceiling double version Product installation 21 4 4 1 Installation of ceiling plate anchoring tube power supply and coverin 21 4 4 2 Installation of structure to the suspension tube22 4 5 Connecting to electrical plant 22 4 6 First startinq eh licei 23 4 7 Installation verification and Products testing operations before 6 23 5 Importance of personal safety 24 5 1 Intended se Zee 24 5 2 Environmental conditions 25 5 3 Technical safety conditions 25 RIMSA Installation and MIU 010 GB 14 02 12 operator s manual Rev 4 Page7 of 34 5 4 Other safety conditions secondary effects 26 6 1 Product description 26 6 2 Description of the operation 27 7 Cleaning and disinfection 28 7 1 Cleaning the Product
4. NA Installation and RIMS IN operator s manual MIU_010_GB 14 02 12 Rev 4 Page 1 of 34 Installation and operator s manual for surgical light system Pentaled12 RIMSA Installation and MIU 010 GB 14 02 12 operator s manual Rev4 Page 2 of 34 Introduction Mark C Conformity Validity of manual Customer service Copyright Dear user You are kindly 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 Pentaled12 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 to assistance and warranty e RIMSA P LONGONI SRL e Via Monterosa 18 e 20831 Seregno MB e Tel 39 0362 325 709 e Fax 3
5. 8 4 Routine maintenance no Period Job Inspect all the lamp joints and make sure they do not squeak If 1 Every 6 months 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 Make sure the Tiges retention screws are tightened properly 2 Onceayear Also check the 6 horizontal arm retention screws and the 3 swing arm screws If these are not properly fastened adequately tighten Check the integrity of the leads from the PCB to the board and that these are fastened properly If they are not proceed to correctly tighten INTERRUPT THE POWER SUPPLY BEFORE PERFORMING THESE OPERATIONS 3 Oncea year 4 Once a year Make sure the line voltage is correct Make sure 24V are reaching the board 5 Once a year Check the condition of the Product paint Make sure there are no paint pieces that could fall on the operating field 8 5 Spare part list Description Order code Sterilizable handle 2180045 Electronic card PENTALED 12 2300617 Electronic card Z300220 Installation and operator s manual RIMSA MIU_010_GB 14 02 12 Rev 4 Page 33 of 34 9 Technical data Technical data on light PENTALED 12 Illumination E at a distance of 1 m Lux 10 50 000 Color temperature K 45 5 000 K 5
6. CEILING PLATE SHEET TEMPLATE SCALE 1 1 DIMA PIASTRA A SOFFITTO SHEET FORMAT A3 FORMATO FOGLIO A3 6 o 6 o gt E amp 6 o 6 o gt E amp Tube length list mm gt Tabella lunghezze tubo mm H mm L mm 2570 200 2600 230 2650 280 2700 330 2750 380 2800 430 2850 480 2900 530 2950 580 3000 630 3050 680 o 3100 730 S 3150 780 3200 830 3250 880 3300 930 3330 960 Drawing code 055 Drawing code 058 wu 9581 6 o 6 o gt E amp Tube length list mm Tabella lunghezze tubo mm pr H mm L mm 2700 2750 2800 2850 2900 2950 3000 3050 3100 3150 3200 3250 3300 3350 3400 Drawing code 070 4 T will CH LRN te ES i 11 PES i R O TPP a e Die 1 ETE YA 3 RED POWER SUPPLIER 100 230 Vac IN 24 Vdc OUT POWER LINE ELECTRICAL PLATE CUPOLA 2300617 Electronic PCB MOO TME SCHEMA GENERALE PENTALED 12 NN ED_028
7. Mechanical anchorage fix the ceiling plate by means of 6 screw anchors Hilti HSL 3 G M8 20 following the directions given by the insert manufacturer scrupulously and listed below for information RIMSA Installation and operator s manual MIU_010_ GB 14 02 12 Rev 4 Page 16 of 34 g o x I Anchor tie rod eo de a SM mm mm mm mm Nm mm mm HSL 3 G M8 20 12 6 E E 25 13 20 do Nominal diameter of the point Mt Closing torsion moment t Minimum depth of drilling Sw Opening of the spanner hs Minimum depth of insertion x Fixing height Length of anchor tie rods 1 Using the paper template attached to this manual mark all the 8 6 fixing holes of the chosen point of the ceiling wall 2 Make the first hole according to the safety anchor diameter 3 By means of a pump or vacuum cleaner with pipe terminal remove the dust and the small drilling fragments from the hole RIMSA Installation and MIU 010 GB 14 02 12 operator s manual Rev 4 Page 17 of 34 Clay cement mix DANGER 4 The anchor tie rod must be inserted into the hole keeping it to axis and using a hammer Attention Consider the insertion depth 5 By the hexagonal dynamometrical spanner tighten with spanner adjusted at the value specified by the constructor of the anchors opening the anchor The anchor tie r
8. POWER SUPPLY SCIALITIC LAMP PENTALED 12 3 RED POWER SUPPLIER 4 BLACK Lu zZ a 100 230 Vac IN 24 Vdc OUT 2300617 Electronic PCB TITOLO TITLE DIS N DRW N SCHEMA GENERALE PENTALED 12 PIANTANA PARETE PHBA d POWER SUPPLY SCIALITIC LAMP PENTALED 12 MOBILE WALL VP LAMPADA PRINCIPALE MAIN LAMP L1 FASE PHASE POWER SUPPLIER L2 NEUTRO NEUTRAL POWER LINE 100 230 Vac IN 24 Vdc OUT CUPOLA Z300617 Electronic PCB MOL MIE SCHEMA GENERALE PENTALED 12 DOPPIA me POWER SUPPLY SCIALITIC LAMP PENTALED 12 DOUBLE LAMPADA SATELLITE SATELLITE LAMP _L3 FASE PHASE POWER SUPPLIER 8 BLACK L4 NEUTRO NEUTRAL z TT z 1 O 100 230 Vac IN 24 Vdc OUT 2300617 Electronic PCB 9 SCHEMA GENERALE PENTALED 12 DOPPIA i RS POWER SUPPLY SCIALITIC LAMP PENTALED 12 DOUBLE
9. The Product is made to light up the area occupied by the patient undergoing surgery or observation 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 Single lamp In compliance with the IEC60601 2 41 standard a single lamp PENTALED12 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 RIMSA Installation and MIU 010 GB 14 02 12 operator s manual Rev 4 Page 25 of 34 Definition Undesired effects caused by superimposition of light fields Safe fastening Wiring systems Authorised personnel Correct assembly and start up Original spares System of operating lamps In compliance with the IEC60601 2 41 standard a system of lamps made up of several lamp units can be used to locally light up the patient s body without any limitation lt 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 an
10. 9 1 2 Packaging transport storage and characteristics of the installation 96 9 1 3Graphic symbols used in the installation manual 10 1 4 Graphic symbols used on the package 11 1 5 Other graphic symbols used on the Product 11 1 6 Warranty Certificate 12 2 Precautions for the appliance operator 13 2 1 Technical safety specifications 13 2 2 Personnel training obligation 13 2 3 Warranty and liabilities 14 2 4 Structural changes or variations 14 2 5 Disposal after use 14 3 Mechanical and electrical arrangement of the site14 3 1 Mechanical arrangement of the site 15 3 2 Electrical arrangement of the site 17 4 Product installation esse 18 4 1 Ceiling Product installation 18 RI NA S A Installation and MIU 010 GB 14 02 12 A operator s manual Rev 4 Page 6 0134 4 1 1 Installation of ceiling plate anchoring tube power supply and 0 6 18 4 1 2 Installation of the structure on the ceiling tube19 4 2 Mobile version Product installation
11. 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 IEC 60601 1 Part 1 General requirements for basic safety IEC 60601 2 41 Part 2 Particular requirements for the basic safety IEC 60601 1 2 Part 1 General requirements for basic safety EMC 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 IX CLASS Par 3 Classification art 1 sub section 1 1 Rule 1 annex IX Reference to technical file Code RIM FT019 e The conformity assessment is developed with reference to article 11 of Directive 93 42 EEC and 2007 47 EC e The RIMSA Quality System complies with UNI EN ISO 9001 and UNI CEI EN ISO 13485 standards and is certified by CSQ CSQ certificate no 9120 RMS1 and 9124 RMS2 Name Paolo Longoni Position Managing Director ZR once D RI NA S A Installation and MIU 010 GB 14 02 12 A operator s manual Rev 4 Page5of34 Table of Contents 1 General information ees eene 8 1 1 Qualification of operators
12. handle 7 WALL version wall box 1 horizontal arm 2 heeling arm 3 lamp head 4 function control keyboard 5 sterilizable handle 6 MIU_010_GB 14 02 12 NA Installation and RIMS N operator s manual Rev 4 Page 27 of 34 See drawing 75 CEILING DOUBLE version ceiling anchorage tube 1 tiges cover 2 horizontal arm 3 heeling arm 4 lamp head 5 function control keyboard 6 sterilizable handle 7 6 2 Description of the operation Control panel The function control keyboard is applied to the Product cupola Such keyboard allows to turn the lamp on and off by means of the membrane key I O 1 to regulate the light intensity by pressing the keys with the symbols 2 and 3 and display the level of intensity reached through 3 green position micro LEDs 4 Light field The light field is fixed and therefore any adjustment of its diameter dimension is prevented RIMSA Installation and MIU 010 GB 14 02 12 operator s manual Rev 4 Page 28 of 34 7 Cleaning and disinfecting 7 1 Cleaning the Product CAUTION Electric shock hazard 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 and 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
13. 9 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 Installation and operator s manual MIU_010_GB 14 02 12 Rev 4 Page 3 of 34 Right to 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 RI NA S A Installation and MIU 010 GB 14 02 12 A operator s manual Rev 4 Page 4 of 34 C Declaration of Conformity of the Manufacturer 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 PENTALED 12 APPLICARE ETICHETTA made by RIMSA P LONGONI S r
14. ation 4 4 1 Installation of ceiling plate anchoring tube power supply and covering Incorrect plate levelling may cause the horizontal arm of the Product to make an undesired spontaneous move when passing from the non balance condition to the balance one Position the template sheet drawing 51 2 on the ceiling 1 fixing it with adhesive tape 3 Make the 8 holes following what is prescribed in paragraph 3 1 After making the holes on the ceiling 1 fix the plate 2 to the ceiling by nuts and lock nuts 3 Fix the anchoring tube 1 to the threaded pins of the ceiling plate 2 by nut and lock nut 3 ensuring the correct rod levelling by means of a spirit level 4 The anchoring tube 1 is supplied with a standard size of 96 cm Using a jigsaw 2 cut the tube to the desired size in relation to the height of the room cut the tube from the side 3 opposite to the one with the fixing hubs 4 for the horizontal arm you should not cut the pipe below a length of 30 cm in order to facilitate the subsequent installation operations To determine the correct length of the tube use the table given the recommended height between floor and lamp head is 200cm Insert the cover 1 on the suspension tube 2 and then insert the suspension tube down to beat into the ceiling plate hub to lock it tighten screw 3 the serrated washer 4 and the nut 5 thus exerting a hub pressing action and allowing the tube tightne
15. cates which danger is being faced Electric shock Mechanical danger due to hanging masses quick release of a suspension arm RIMSA Installation and MIU 010 GB 14 02 12 operator s manual Rev4 Page 11 of 34 EN Fe I a ES MEE 1 4 Graphic symbols used on the package The symbols present on the boxes of the packages are listed below High side of the package Maximum number of packages stackable Breakable package Humidity suffering package Do not overlap packages with pallet Weight of the package 1 5 Other graphic symbols used on the Product The symbols present on the Product are listed below B Type device Indicates the level of protection against direct and indirect contact Graphic symbol proving the CE marking of the product Symbol indicating the manufacture date month and year Fuses used by the device RI NA S A Installation and MIU 010 GB 14 0212 A operator s manual Rev 4 Page 12 of 34 1 6 Warranty Certificate The appliance is covered by an 18 month warranty including electrical parts The warranty begins on the date of Product shipment from the RIMSA warehouse to the buyer In case of disputes the date indicated on the transport document attached to the goods shall be deemed valid The warranty only covers the sending of Product spare parts to the buyer or in the event of RIMSA conside
16. d reduced blood supply considerable damage to tissues If reduced blood supply or the start of tissue dehydration occurs reduce the light intensity 5 2 Environmental conditions The Product is not suitable for use in explosion risk areas The Product is not suitable for use in the presence of inflammable mixtures of anaesthetics with air oxygen or NO laughing gas During operation the ambient temperature must be between 10 C and 40 C Relative humidity must be between 30 and 75 Atmospheric pressure must be between 700 and 1060hPa 5 3 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 Product 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 regard to assistance repairs structural changes and additional accessories only original Rimsa spare parts are used RIMSA Installation and MIU 010 GB 14 02 12 operator s manual Rev 4 Page 26 of 34 Optical safety Incorrect use Covering the heads Knocks Versions See drawing 63 Se
17. e Special maintenance Assistance Cleaning Demolition Packaging Transport Electrical installation must be made in compliance with the IEC 60364 7 710 standard and any national regulations and must contemplate protection with fuses or thermal magnetic disconnection switch and the fitting of a master switch able to ensure the complete interruption of the power supply to the Product The Product is a ME EQUIPMENT and consequently falls within the field of application of the EN 62353 standard Consequently any operation performed on the Product must be carried out in compliance with the EN 62353 standard where applicable 1 1 Qualification of operators This paragraph describes the requirements and qualifications which the operators involved in the various stages of Product life and use must possess the Product must be installed by a qualified Installer and or Technician Professional medical personnel Qualified technician in possession of professional technical requirements Qualified technician in possession of professional technical requirements Dealer who has attended a technical course on the Product organised by the manufacturer Properly trained medical and paramedical personnel at the end of the Product life cycle dispose of the used Product in an environment friendly way and in compliance with the national directives applicable to waste disposal 1 2 Packaging transport storage and characteristics of the installat
18. e drawing 64 See drawing 74 5 4 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 6 Product description and operation 6 1 Product description The Product is available in different versions mobile ceiling wall ceiling double MOBILE version wheel base 1 stand 2 stand extension 3 heeling arm 4 lamp head 5 function control keyboard 6 sterilizable handle 7 power supply plug 8 CEILING version ceiling anchoring tube 1 ceiling cover 2 horizontal arm 3 heeling arm 4 lamp head 5 control keyboard 6 sterilizable
19. e heeling arm and head Align the heeling arm pin 8 with the floor stand 1 After connecting the electric cable terminals 9 to 10 each other insert the heeling arm pin into the stand fitting in the holes 11 with those of the stand 12 and screw in the two locking screws 13 by a screwdriver 4 3 Wall version Product installation 4 3 1 Installation of wall plate and power supply Incorrect plate levelling may cause the horizontal arm of the lamp to make an undesired spontaneous move when passing from the non balance condition to the balance one Position the template sheet drawing 11 2 on the wall 1 fixing it with adhesive tape 3 Make the 6 holes following what is prescribed in paragraph 3 1 After making the holes on the wall 1 following what is prescribed in paragraph 3 1 fix the plate 2 to the ceiling ensuring the correct plate levelling by means of a spirit level 3 4 3 2 Structure installation Align the horizontal arm pin 1 with the anchoring tube 2 Connect the connectors 3 and 4 RIMSA Installation and MIU 010 GB 14 02 12 operator s manual Rev4 Page 21 of 34 ATTENTION See drawing 52 See drawing 53 See drawing 69 See drawing 70 See drawing 71 See drawing 72 Insert the pin into the tube fitting in the relevant fixing holes and fix it screwing in the four screws 5 using a hexagonal wrench 6 4 4 Ceiling double version Product install
20. eplaces legal warranties for faults and non conformities and rules out any other possible liability of RIMSA originating from the supplied Products The payment of any damages to persons or things due to Product malfunction or faults shall be limited to the maximum amount of RIMSA s insurance coverage for civil liability 10 The warranty shall be automatically invalidated in the event of the Product having been tampered with or modified by the buyer or third parties RI NA S A Installation and MIU 010 GB 14 0212 A operator s manual Rev 4 Page 13 of 34 the Product having been repaired by the buyer or third parties without following the instructions in the instruction manuals the Product serial number having been cancelled defaced or removed the buyer not being up to date with payments 11 For jobs to be done under warranty the buyer shall contact RIMSA only 12 The component parts replaced under warranty must only be returned to RIMSA if so requested by RIMSA carriage free and suitably packed 13 In case of failure to return a part requested RIMSA the cost of the component part will be charged 14 RIMSA cannot accept returns from end users or in any case from parties other than the buyer 15 Products returned to RIMSA must be complete with documentation authorising such return and another document describing the malfunction 16 For everything not indicated on this warranty cert
21. ificate reference shall be made to the laws of Italy 17 For all disputes deriving from or related to the orders to which this warranty certificate applies and which cannot be amicably settled between the parties the only competent law court shall be that of Milan 2 Precautions for the appliance operator 2 1 Technical safety specifications Cleaning personnel The Product cleaning and disinfecting operations described in Chapter 7 must only be performed by duly trained personnel Servicing personnel The inspection and maintenance operations described in Chapter 8 must only be performed by professional technical personnel 2 2 Personnel training obligation Instructing users 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 RIMSA Installation and MIU 010 GB 14 02 12 operator s manual Rev 4 Page 14 of 34 Arbitrary changes Only use original Rimsa spare parts Disposal at the end of life cycle NOTE 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 organised by the manufacturer or by a professional technician the Product not being used for the purpose
22. ion site Boxes containing the whole structure with installation manual and user manual Transport is carried out by any road haulage contractor as long as they respect the following characteristics Temperature C 15 60 RIMSA Installation and MIU 010 GB 14 02 12 operator s manual Rev 4 Page 10 of 34 Storage Installation site Humidity 10 75 96 Atmospheric pressure h Pa 500 1060 The devices packaged must be stored warehoused in a dry place and at the following temperature Temperature C 15 60 Humidity 10 75 96 Atmospheric pressure h Pa 500 1060 The site appointed for the installation of the equipment must have the following characteristics Temperature C 10 40 Humidity 30 75 Atmospheric pressure h Pa 700 1060 1 3 Graphic symbols used in the installation manual In this installation manual and on the Product important directions are marked by means of symbols and identifying words Identifying words such as DANGER WARNING or CAUTION indicate the classification of the risk of damage DANGER signals an immediately dangerous situation which might cause death or serious damage WARNING signals a potentially dangerous situation which might cause death or serious damage CAUTION signals a potentially dangerous situation which might cause moderate or slight damage The following triangular symbol coupled with a side explanation indi
23. isclaims all liability for any injuries to persons or damage to things caused by the installation maintenance or use of the Product by unqualified operators By qualified operator is meant whosoever has attended a course relating to the installation maintenance and use of the product organised by RIMSA or alternatively whosoever has carefully read this installation manual The only party responsible for Product installation is the buyer s customer itself no cost or responsibility relating to installation and or commissioning of the Product shall therefore be traced back and or in any case attributed to RIMSA The masonry works involving the preparation of the ceiling or wall for Products to be installed on the ceiling or wall respectively and the electric works for preparing the power supply system for the Product shall be of a sturdy and safe nature and completed in a workmanlike manner by suitably trained personnel By way of example only without limitation the following professional figures are deemed adequately trained gt Building Engineer Draughtsman Building firm duly registered in the professional Register for masonry works gt Electro technician qualified to exercise the profession of electrician for the electrical works RIMSA Installation and MIU 010 GB 14 02 12 operator s manual Rev 4 Page 9 of 34 CAUTION CAUTION Operator qualification Installation Use Routine maintenanc
24. ng professionals Building Engineer Surveyor Building Contractor duly registered with the Professional Register In case of improper drilling e g drilling of a piece of iron of the reinforced concrete the technician responsible for the construction will have to be informed for safety reasons since the statics of the premises might be compromised The ceiling must have a capacity of at least 300 Kg m and a thickness of at least 250 mm The installation site must be declared fit for use After making sure that the site used as medical premises complies with the requisites required above proceed to the mechanical anchorage of the ceiling plate determining the type of ceiling for the anchorage and acting accordingly The installer assumes all responsibility technical civil and legal related to the correct and suitable arrangement of the anchorage and installation of the Product which must be carried out according to the standards The Product is supplied complete with ceiling attachment tiges counter plate wall attachment wall plate Tiges length varies in relation to the height of the premises in which the Product is to be installed The anchoring tube is calculated to install the Product at a finished height from the floor to the cupola of the Product with the oscillating arm in a horizontal position of about 190 200 cm save a different request from the client As a non exhaustive example we list some of the types of slab
25. o the ceiling by nuts and lock nuts 3 Fix the anchoring tube 1 to the threaded pins of the ceiling plate 2 by nut and lock nut 3 ensuring the correct rod levelling by means of a spirit level 4 The anchoring tube 1 is supplied with a standard size of 100cm Using a jigsaw 2 cut the tube to the desired size in relation to the height of the RIMSA Installation and MIU 010 GB 14 02 12 operator s manual Rev 4 Page 19 of 34 See drawing 56 See drawing 57 room cut the tube from the side 3 opposite to the one with the fixing holes 4 of the horizontal arm To determine the correct length of the tube use the table given the recommended height between floor and lamp head is 200cm Insert the anchoring tube 1 down to beat into the ceiling plate hub 2 keeping the cut side upwards to lock it tighten screw 3 the serrated washer 5 and the nut 4 thus exerting a hub pressing action and allowing the tube tightness By a drill 1 make a 7mm diameter hole on the tube side near the nut M8 2 welded on the plate hub then insert and screw the M8 conical pointed dowel supplied in the nut 3 until its conical point presses against the hole previously obtained in the anchoring tube A DANGER Product falling danger See drawing 58 See drawing 59 See drawing 60 Make sure that the Product power supply cable 1 can reach the power supply board 2 of the Product
26. od will immediately take the weight 6 Make the remaining 7 5 holes and insert the anchor tie rods as in previous points 2 5 7 After one hour tighten the anchor tie rods again with the tightening torque prescribed Chemical anchorage fix the tiges with n 8 6 chemical injection anchors mod Hilti HIT HY 150 with HAS following the directions given by the manufacturer Hilti scrupulously After arranging the chemical anchors to the CEILING WALL fix the tiges with nuts and lock nuts for each tie rod and tightening with the hexagonal dynamometrical spanner you will tighten with spanner adjusted at the value specified by the constructor of the anchors In this case it is compulsory to enclose the slab sandwich like by the Product plate and the counter plate Plate and counter plate must be enclosed to each other with M8 steel threaded bars each blocked at the upper and lower ends by respective washers nuts and lock nuts 3 2 Electrical arrangement of the site The electrical system arrangement works of the site used as medical premises to power the Product must be carried out in a safe way according to the standards by qualified personnel By qualified personnel we mean including but not limited to the following professionals Electro technician licensed to practise as electrician RIMSA Installation and MIU 010 GB 14 02 12 operator s manual Rev 4 Page 18 of 34 DANGER ATTENTION See d
27. on is ensured by installing on the input line F N two fuses type 5x20 T 1A for 230V or 5x20 T 2A for 110V As for floor versions it is necessary to connect wires by the electric panel of the device to do it lift the connecting ring 1 and the cover 2 Now connect the connectors 3 4 and 5 6 Then reinstall the cover and the connecting ring and fix the cover by a screwdriver 7 tightening the screw M4 8 and gripping inside the threaded bush 9 present on the electric panel support CAUTION Irreparable damage to the Product In the case of ceiling versions the fuse protection to the electric panel terminals must be inserted ONLY AFTER completing the mechanical and electrical assembly of the Product Advance insertion may cause irreparable damage to the light source If the product is not used for long periods remove the fuses RIMSA Installation and MIU 010 GB 14 02 12 operator s manual Rev 4 Page 23 of 34 ATTENTION CAUTION 4 6 First starting Before supplying the Product with voltage remove the protection film from the mobile base cover Now it is possible to power the Product to make sure it gives out light To do so you must 1 close the system circuit by means of the head system switch charged to the customer 2 press the green switch on the base cover Mobile version 3 press the I O keyboard 4 7 Installation verification and Produc
28. ot wet cloth 7 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 two lateral safety keys of the handle and extract the handle itself insert the handle till the bottom until the safety keys don t fall in their seats 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 RIMSA Installation and MIU 010 GB 14 02 12 operator s manual Rev 4 Page 30 of 34 Steam sterilization at 134 C 2 3 bar for 4 minutes Position the handpieces straight with open side downwards Do not exceed a sterilization temperature of 134 C Avoid the handpieces coming into contact with other objects during the disinfection proce
29. rawing 52 See drawing 53 See drawing 54 See drawing 55 Before installing the Product check the following conditions the electrical system of the installation site must comply with the national laws and or regulations in force for electrical systems in sites used as medical premises the electrical system must be certified by an electrician licensed to issue the conformity certificate the verification of the grounding circuit must be certified as required by the norms in force 4 Product installation Before installing the Product make sure that all the packages are present and in good condition without any transport related damage and that the contents correspond to what is specified above Claims will be considered only if the seller or the forwarder are informed immediately Each claim must be in writing Goods are always carried at the buyer s risk Keep the original package in case the lamp must be sent back 4 1 Ceiling Product installation 4 1 1 Installation of ceiling plate anchoring tube power supply and covering Incorrect plate levelling may cause the horizontal arm of the Product to make an undesired spontaneous move when passing from the non balance condition to the balance one Position the template sheet drawing 51 2 on the ceiling 1 fixing it with adhesive tape 3 Make the 8 holes following what is prescribed in paragraph 3 1 After making the holes on the ceiling 1 fix the plate 2 t
30. ring the replacement of spare parts not feasible the replacement of the entire Product after fabrication faults have been properly ascertained at the undisputable judgement of RIMSA The warranty does not therefore cover any other costs or expenses including by way of example but without limitation labour costs packaging costs and transport costs etc The guarantee does not include the components subject to normal wear such as halogen bulbs LEDs fuses relays ball bearings etc The warranty does not cover malfunctions due to failure to comply with the instruction manuals malfunctions due to installation and or maintenance errors malfunctions or faults caused by carelessness negligence incorrect use or other causes not attributable to RIMSA malfunctions or faults due to the fact that the electrical system of the premises where the machine is installed is not in compliance with International or local standards for electrical systems in premises used for medical purposes and similar standards RIMSA shall repay direct damages suffered by the buyer and which are documented as attributable to its Product caused within the warranty period for an amount not above 40 of the net value of the product as indicated on the buyer s invoice RIMSA s liability is expressly ruled out for indirect damages or consequential damages including cases of the lamp not being used deriving from the supply This warranty certificate r
31. s 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 manufacturers 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 Mechanical and electrical arrangement of the site The building and electrical arrangement works for the installation of the Product are the responsibility of the Final Customer RIMSA Installation and MIU 010 GB 14 02 12 operator s manual Rev 4 Page 15 of 34 DANGER DANGER CAUTION Fixing positions Reinforced concrete 3 1 Mechanical arrangement of the site The building slab arrangement works to install the Product must be carried out in a solid and safe way according to the standards by qualified personnel By qualified personnel we mean including but not limited to the followi
32. ss By a drill 1 make a 7mm diameter hole on the tube side near the nut M8 2 welded on the plate hub then insert and screw the M8 conical pointed dowel supplied in the nut 3 until its conical point presses against the hole previously obtained in the anchoring tube RIMSA Installation and MIU 010 GB 14 02 12 operator s manual Rev 4 Page 22 of 34 See drawing 73 4 4 2 Installation of structure to the suspension tube Align the horizontal arm pin 1 with the anchoring tube 2 Connect the connectors 3 and 4 Insert the pin into the tube fitting in the relevant fixing holes and fix it screwing in the four screws 5 using a hexagonal wrench 6 Repeat the same operations for the second horizontal arm At the end of the installation close the openings of the support tube through supplied silicone caps 7 4 5 Connecting to electrical plant DANGER Danger of electric shock Fuses See drawing 62 Before connecting make sure that the electrical system line is NOT under tension The Product power supply group support sheet feeder terminal board is firmly fixed to the plate of the anchoring tube to the base or to the wall box in case of a ceiling mobile or wall version device respectively As regards the connection of the electrical system line F N and the lamp cables T follow what is specified in the specific wiring diagram attached The device fuse protecti
33. ss 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 7 4 Yearly inspections by the operator IMPORTANT See drawing 65 Keep to the yearly inspection schedules and inspect the product according to IEC 62353 standard 8 Adjustments 8 1 Adjustment of the swing 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 Slide the rubber grommet forward 1 and the cover 2 along the heeling arm 3 Insert a pin 4 having maximum diameter of 4mm into the holes of the ring nut 5 and rotate in the directions of the arrows to increase decrease the charge of the spring If the heeling arm lowers the elastic force of the spring is insufficient rotate the lever downwards to charge the spring If the heeling arm still goes up the elastic force of the spring is too high rotate the lever upwards to discharge the spring After making adjustments return the covering to its original position RIMSA Installation and operator s manual MIU 010 GB Rev 4 14 02 12 Page 31 of 34 See drawing 65 Horizontal arm brakes 8 2 Adjustment of the braking force As for all
34. the mechanic parts brakes also are subject to wear and tear If the lamp body does not automatically keep the position it is put to it is necessary to adjust the braking force by acting on the screws of the brakes Use a 2 5 hexagonal wrench 7 to increase the braking force rotating the arm brake dowels 6 clockwise 8 3 Troubleshooting EN Problem Solution Make sure the plate fitted on the wall wall is o perfectly flat that the stem is flat on the base mobile 1 The Product does not remain in and that the tube secured to the ceiling ceiling is position level Further tighten the brakes on the joints so as to increase friction Check the presence of the fuses inside the terminal 2 The Product fails to work box T1A for 230V or T2A for 110V the hooking of the electrical connectors Check the presence of voltage in the lamp head Check the characteristics of the fuses inserted The fuse continues to burn out T1A with 230VAC T2A with 100VAC 4 light flickers and produces a cantar stroboscopic effect The light beam on the operating field 5 is not focalised defective meeting of Contact the service conter light fields i The Product does not switch on Check the power supply voltage and fuses Electronics are damaged contact the service center RI NA S A Installation and MIU 010 GB 14 0212 A operator s manual Rev 4 Page 32 of 34
35. ts testing operations before use The following notes are to be considered compulsory during verification of the installation since they prove the correct verification of all the points set out For such reason it is necessary to tick each point when it is treated 1 Verify the suitability of the ceiling wall on installation of the Product 2 By means of a spirit level make sure the anchoring tube or wall plate is perpendicular 3 Make sure the bolt is well tightened on the locking clip RIMSA Installation and MIU 010 GB 14 02 12 operator s manual Rev 4 Page 24 of 34 Use in compliance with standards Field of work Definition 4 Check the hole and make sure the safety dowel is inserted on the anchoring tube 5 Make sure the 4 screws M4 supporting the horizontal arm ceiling and wall version are well tightened 6 Make sure the mobile stand pawl is properly inserted into the relevant base seat 7 Check the Product earthing and make sure the earthing terminals are well tightened 8 Make sure the movement mechanism works perfectly Check the mechanical operation of the Product by directing and rotating it and make sure that all movements are frictioned so that the Product is stable in any position and does not lose its position 9 After turning on the Product it must give out light from the cupola Seal and signature of the installer 5 Importance of personal safety 5 1 Intended use
36. 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 7 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 Installation and MIU 010 GB 14 02 12 operator s manual Rev 4 Page 29 of 34 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 aluminium 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 n
37. without creating interferences with the anchoring tube Then position the cover 3 and the relevant locking ring 4 4 1 2 Installation of the structure on the ceiling tube Insert the connection cables 7 along the anchoring tube making them out from the tiges plate so they can reach the connection terminals of the electrical panel Align the horizontal arm pin 3 with the anchoring tube 4 Connect the connectors 1 and 2 Insert the pin into the tube fitting in the relevant fixing holes and fix it screwing in the four screws 5 using a hexagonal wrench 6 4 2 Mobile version Product installation 4 2 1 Installation of stand power supply and covering Remove the bolt 2 from the stand bottom 1 RIMSA Installation and MIU 010 GB 14 02 12 operator s manual Rev 4 Page 20 of 34 Mechanical connection Position the stand 1 on the base 5 fitting and inserting its pawl 6 into the plate seat 7 use the bolt previously unscrewed to join the stand to the base and tighten thoroughly Insert the cover 3 from the stand top and the relevant connecting clip 4 A WARNING Instability and falling danger See drawing 61 ATTENTION See drawing 66 See drawing 67 See drawing 68 Failure to insert the detent into the appropriate seat present on the basement plate implies the risk of instability and the possible fall of the structure 4 2 2 Installation of th
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