Instruction manual for installation and use of scialytic - Tecno-Gaz
Contents
1. use and installation Revo ea 9 Technical data Technical data on light PENTALED 9 FF Illumination E at a distance of 1 m Lux 10 50 000 Color temperature K 5 5 000 K 5 Color rendering index Ra 94 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 50 000 frequency of use Light intensity control 50 100 General data Color RAL 9003 Directive 93 42 EEC Standard EN 60601 2 41 Instruction manual for M U _010_GB 19 01 10 a use and installation Revo Page 300 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 Scialytic wall mobile ceiling lamp weight Kg 18 13 Certificates CE Complying with directive 93 42 EEC Instruction manual for use and installation MIU_010_GB 19 01 10 Rev2. 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 heeling arm and head See drawing 61 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 Electrical system connection A WARNING Electric shock Before connecting make sure that the electrical system line is NOT under tension The lamp power supply group support sheet feeder terminal board is firmly fixed to the plate of the anchoring tube or the base in case of a ceiling version or floor 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 Fuses The device fuse protection is ensured by installing on the input line F N two fuses type 5x20 T 1A See drawing 62 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 grip
3. Instruction manual for MlU_010_GB 19 01 10 a TECNO GAZ f Up use and installation Rev 0 Page 1 of 31 Instruction manual for installation and use of scialytic lamp Pentaled12 TECNO GAZ Uy Instruction manual for MlU_010_GB 19 01 10 use and installation Rev 0 Page 2 of 31 Introduction Mark Conformity Manual s validity Customer service Copyright Modification rights reserved Dear installer we ask you to read this manual carefully before installing the product By doing so you will be able to protect yourselves and all the possible future users against any damage This apparatus is a Class medical device in accordance with the European Directive on medical devices MDD 93 42 EEC June 1993 Appendix 9 The manufacturer represents that this product complies with the essential requisites of the MDD Appendix 1 and proves such conformity by affixing the EC mark This instruction manual for the installation of wall anchor lamps is valid for the following models e Pentaled12 The customer service is at your disposal in case of any questions as to the device and its use if you wish to order spare parts and for service and warranty reasons e TECNO GAZ e Strada Cavalli 4 e 43038 Sala Baganza Parma e T l 39 0521 83 39 26 e Fax 39 0521 83 33 91 e e mail info tecnogaz com The contents of this Manual can be mod
4. Plana 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 device The symbols present on the lamp are listed below B Type device Indicates the level of protection against direct and indirect contact Graphic symbol proving the EC marking of the product Symbol indicating the manufacture date month and year Fuses used by the device Danger symbol laser beam in class II TECNO GAZ Uy i Instruction manual for M _010_GB 19 01 10 use and installation Rev 0 bar Cover on the product Starting date of the warranty Transport Document Date Repairs Standard wear Exclusion Replacement Improper use Use stop Loss of warranty 1 6 Warranty 1 The product is covered by guarantee for a period of 12 months including electric parts 2 The warranty becomes effective from the lamp installation date at the customer s premises exclusively if the installation is carried out by Tecno Gaz personnel In any other case the warranty becomes effective from the lamp dispatch date from Tecno Gaz warehouse to the customer s premises 3 In case of contention the date specified on the Transport Document given
5. 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 wall 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 100cm 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 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 TECNO GAZ Up Instruction manual for M U _010_GB 19 01 10 use and installation Rev 0 cede See drawing 56 See drawing 57 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
6. against the hole previously obtained in the anchoring tube A WARNING Lamp falling danger See drawing 58 See drawing 59 See drawing 60 Mechanical connection Make sure that the lamp power supply cable 1 can reach the power supply board 2 of the lamp 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 Installation of the floor version lamp 4 2 1 Installation of stand power supply and covering Remove the bolt 2 from the stand bottom 1 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 Instruction manual for M U _010_GB 19 01 10 use and installation Rev 0 jae TECNO GAZ Uy A WARNING Instability and falling danger
7. luminaire In accordance with EN60601 2 41 a PENTALED 12 single lamp is a minor surgical luminaire and can be used only on operations where the interruption of the lighting does not cause any risks for the patient 5 2 Environmental conditions The PENTALED 12 scialytic lamp system is not suitable for the use in explosion risky areas The PENTALED 12 scialytic lamp system is not suitable for the use in the presence of inflammable mixtures of anesthetics with air oxygen or NO laughing gas During working the room temperature must be between 10 C and 40 The relevant humidity must be between 30 and 75 The atmospheric pressure must be between 700 and 1060hPa 5 3 Technical safety conditions The safe use and proper working of the PENTALED 12 lamp is guaranteed if anchorage of the lamp to the ceiling wall is safe from the static point of view and __ there is a static stability test the electrical systems of the sites concerned comply with the local norms in force changes or maintenance of the lamp are made by Tecno Gaz authorized personnel TECNO GAZ Up Instruction manual for M U _010_GB 19 01 10 use and installation Rev 0 eer Proper installation and commissioning Original spare parts Dazzling Improper use Cover the heads Collisions Versions See drawing 63 See drawing 64 the lamp has been installed following the currently valid installation in
8. with the national laws and or regulations in force for electrical systems in sites used as medical premises and the national laws and or regulations in force the electrical system must be certified by an electrician licensed to issue the conformity certificate the verification of the earthing must be certified as required by the norms in force Upstream of the device the plant must provide a magneto thermic switch sited on the line which distributes power to the lamp itself this switch must have a distance between the contacts of at least 3 mm TECNO GAZ Uy Instruction manual for M U _010_GB 19 01 10 use and installation Rev 0 faa ATTENTION See drawing 52 See drawing 53 See drawing 54 See drawing 55 4 Product installation Before starting the installation make sure that no package is missing in bad condition or damaged during transport and that the contents conform to what is specified above Complaints will be considered only if the seller or the forwarder are warned immediately Each complaint must be made in writing Goods are always carried at the buyer s risk Keep the original package in case the lamp is to be returned 4 1 Ceiling version lamp installation 4 1 1 Installation of ceiling plate anchoring tube power supply and covering Incorrect plate levelling may cause the horizontal arm of the lamp to make an undesired spontaneous move when passing from the non balance
9. 0 Page 31 of 31 Notes
10. al arm 3 heeling arm 4 lamp head 5 control keyboard 6 sterilizable handle 7 TECNO GAZ Uy i Instruction manual for MIU_010_GB 19 01 10 use and installation Revo Page e401 Pannello di comando Light field 6 2 Description of the operation The function control keyboard is applied to the scialytic lamp head 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 The light field is fixed and therefore any adjustment of its diameter dimension is prevented 7 Cleaning and disinfection 7 1 Cleaning the device WARNING Electric shock danger Turn off the lamp by the master switch of the operating room and make sure it does not turn on again in the case of floor versions remove the power supply plug from the electric system socket protect the device against water sprinkling and do not clean disinfect it with liquids TECNO GAZ Up Instruction manual for M U _010_GB 19 01 10 use and installation Rev 0 eae ATTENTION Clean with alcohol low alkaline and chlorine less detergent Do not use abrasive products petrol paint thinners alkaline detergents acids proportion the detergents so that so that no liquids seep int
11. allation Rev 0 eae TECNO GAZ Uy 7 4 Yearly inspections by the keeper A ATTENTION Respect the yearly inspection intervals and check the device as follows damage to the painting with danger in case of open wounds cracks on the plastic part detachment of parts integrity of the earthing circuit 8 Adjustments 8 1 Adjustment of the swing arm See drawing 65 The lamp is supplied already balanced and needs no further adjustment If in time the spring balancing swing arm stiffens or loosens it is possible to intervene mechanically adjusting 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 At the end of the adjustment put the cover back to its original position 8 2 Adjustment of the braking force See drawing 65 As for all 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 acti
12. aphic symbols used on the device ecceeeeeeeeeeeeeeeeees 9 dey Waray eese E EA E Aa eh ee a EE 10 2 Instructions for the device keeper eeeeeeeeeeeeeeeeeees 12 2 1 Technical safety characteristics cececeeeeeeeeeeeeeeeeeeeeeeeeeeeees 12 2 2 Personnel instruction obligation ceeeeeeeeeeeeeeeeeeeeeeeeeeeaaeeees 12 2 3 Warranty and responsibility ccceseeeeeeeeeeeeeeeeeeeeeeeeeeeeaeeees 12 2 4 Structural changes or variations cceeeeeeeeeeeeeeeeeeeeeeeeeeeeaaees 12 2 5 Disposal after use isiccesiscisvcstsesencudncstucatswbancatuebsanedasaaensaubaeastwenns 13 3 Mechanical and electrical arrangement of the site 13 3 1 Mechanical arrangement of the Site cece eeeeeeeeeeeeeeeeeeeeee teens 13 3 2 Electrical arrangement of the Site cee eeeeeeeeeeeeeeeeeeeeeeeeeeeeeeees 16 4 Product installation cccccceeeceeeeee eneee eee eeaeeeeeeeeaaeeeeeeed 17 4 1 Ceiling version lamp installation ccceeeeeeeeeeeeeeeeeeeeeeeeeeeeeees 17 4 2 Installation of the floor version lamp eeeeeeeeeeeeeeeeeeeeeeeeeeeees 18 4 3 Electrical system connection ctassticeacnes chnenrrer ances atenerenireneriadeninehs 19 in Instruction manual for MlU_o10_GB 19 01 10 wpee2 use and installation Rev 0 Page 6 of 31 Bh AUS SWUM TN Macc cae it es ie ale hu cae deh ERE 23 4 5 Installation c
13. e stored warehoused in a dry place and at the following temperature Temperature C 15 60 Humidity 10 75 Atmospheric pressure h Pa 500 1060 Instruction manual for M U_010_GB 19 01 10 use and installation Rev 0 Page 8 of 31 Installation site 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 this installation manual In these installation instructions and on the lamp important directions are marked by means of symbols and identifying words Identifying words such as DANGER WARNING or ATTENTION indicate the classification of the risk of damage This is highlighted with various symbols 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 ATTENTION signals a potentially dangerous situation which might cause moderate or slight damage The following triangular symbol coupled with a side explanation indicates which danger is being faced Electric shock Mechanical danger due to hanging masses quick release of a suspension arm Instruction manual for MlU_010_GB 19 01 10 use and installation Rev 0 Page 9 of 31 x lt He IIe S BI 3 x e
14. forced concrete 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 do do t hs l Mt SW x Anchor tie rod mm mm mm mm Nm mm mm HSL 3 G M8 20 12 80 60 98 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 l Length of anchor tie rods ecno qaz struction manual for M1U 010 SB 190110 bid use and installation Revo Page 18 ol 1 Using the paper template attached to this manual mark all the 8 fixing holes of the chosen point of the ceiling 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 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 rod will immediately take the weight 6 Make the remaining 7 holes and insert the anchor tie rods as in previous points 2 5 7 After one h
15. heck and scialytic lamp testing operations before use 22 5 Importance of personal safety cece ceeeeeeeeeeeeeeeeeeeeeeees 22 Bil intended Se zornein aN N N 22 5 3 Technical safety CONCMON Sir cicsereieteraveeteadet aden aacadpatenatess 22 5 4 Other safety conditions secondary effects eceeeeeeeeeeeeeees 23 6 Lamp description and operation ccceceeeeeeeeeeeeeeeeeeees 23 6 1 Description of the COVICC iiss cece ence cain hetcelee iced Ohare nee 23 6 2 Description of the Operation ceccceseeeeeeeeeeeeeeeeeeeeeeeeeeeeaeeees 24 7 Cleaning and disinfection c cece cece eee eee eeeeeeeeeeeeaaeeees 24 7 1 Cleaning the COVIC avi sicsse nieces sarieniere nine cine va se ninrie Suna rienicainganianieanenicd 24 Poe DISIMOCUOM aama a A hchabeaheuchebe 25 7 3 Sterilizing the handpieces aa i Astat abla eatias canadian 26 7 4 Yearly inspections by the keeper ccceeeeeeeeeeeeeeeeneneeeeeeeneees 27 8 ACJUSTIMONUS iiini ian danei iaeiaiai ainai 27 8 1 Adjustment of the swing arm cc cceeeeeeeeeeeeee eee eeeeeeeeeeeeeeeeeaaaeees 27 8 2 Adjustment of the braking force c ceeeeeeeeeeeeeeeeeeeeeeeeeeaeeees 27 8 3 Search for FANUC csvset carinii te ine are Mone Suchen aiagerfnie riences 28 8 4 Spare part UST eiris inann nei iea a a pain teenies 28 9 Techni aldata Ana ana EN N 29 Instruction manual for MlU_010_GB 19 01 10 use and installa
16. ified by Tecno Gaz without notice or further obligations in order to include variations and improvements Copy or translation of any part of this manual without written consent by Tecno Gaz is forbidden Tecno Gaz reserves the right to modify cancel or otherwise change the data contained in this documentation at any time and for any reason without notice since Tecno Gaz is constantly searching for new solutions TECNO GAZ Uy Instruction manual for M U_010_GB 19 01 10 use and installation Rev 0 Page 3 of 31 IMPORTANT for the development of the products We therefore reserve the right and duty to make changes in the devices supplied in terms of form equipment and technology Please find attached a warranty coupon to be filled in and sent back to Tecno Gaz Such coupon completes e the traceability of the medical device as required by the MDD e the Cover on the Product the confirmation of the complete reading of the manual by the installer as a necessary and sufficient clause so that he she is declared FIT for the installation of the equipment having all the necessary information for the installation through this manual Instruction manual for MlU_010_GB 19 01 10 use and installation Rev 0 Page 4 of 31 Manufacturer s declaration of conformity CE The Company TECNO GAZ S P A ubicata in Strada Cavalli n 4 CAP 43038 Sala Baganza Parma ITALIA declares
17. iling is suitable for installing the lamp 2 By means of a spirit level make sure the anchoring tube is perpendicular Make sure the bolt is well tightened on the locking clip 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 version are well tightened 6 Make sure the floor stand pawl is properly inserted into the relevant base seat 7 Check the device earthing and make sure the earthing terminals are well tightened 8 Make sure the movement mechanism works perfectly Check the mechanical operation of the lamp by directing and rotating it and make sure that all movements are frictioned so that the lamp is stable in any position and does not lose its position 9 After turning on the lamp it must give out light from the head Seal and signature of the installer TECNO GAZ Uy i Instruction manual for M U _010_GB 19 01 10 use and installation Rev 0 eae Use compling with the norms Work field Definition Safe anchorage Systems Authorized personnel 5 Importance of personal safety 5 1 Intended use The PENTALED 12 scialytic lamp is used to light the area of the patient undergoing a surgical operation or an examination and intended to be used in operating rooms or medical clinics The work field is a distance from about 70 to 140 cm from the operation point Single lamp minor surgical
18. l laws and or regulations in force for electrical systems in sites used as medical premises and similar norms the equipment is not used in accordance with the instructions for use TECNO GAZ Uy i Instruction manual for M U _010_GB 19 01 10 use and installation Rev 0 rear Cleaning personnel Service personnel Instructing the users Arbitrary changes Use Tecno Gaz original spare parts only 2 Instructions for the device keeper 2 1 Technical safety characteristics The cleaning and disinfection operations of the scialytic lamp system described in Chapter 7 must be carried out exclusively by duly instructed cleaning personnel The control and maintenance operations described in Chapter 8 must be carried out exclusively by qualified service personnel 2 2 Personnel instruction obligation Instruct the personnel following the instructions for use as regards the lamp control cleaning and care operations Such personnel must be instructed by the keeper according to what is specified in this manual 2 3 Warranty and responsibility Tecno Gaz refuses all responsibility for the unreliable working of the scialytic lamps in case the installation the changes and the repairs are not carried out by a Tecno Gaz service technician or personnel authorized by Tecno Gaz the device is not used in accordance to its intended use the norms and the instructions for use 2 4 Structural changes o
19. ly 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 Instruction manual for MIU_010_GB 19 01 10 use and installation Revo eee TECNO GAZ Uy Fixing positions The scialytic lamp is supplied complete with tiges Its length varies in relation to the height of the premises in which the lamp is to be installed The tiges is calculated to install the lamp at a finished height from the floor to the head of the lamp 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 Rein
20. might fall on the area of the wound The lamp keeper must respect the requisites imposed by the national competent hygiene and disinfection commission Installation uninstallation of the handpiece press the two lateral safety keys of the handpiece and extract the handpiece itself insert the handpiece till the bottom until the safety keys don t fall in their seats Cleaning disinfection and sterilization of the handpiece the handpieces are made of plastic material resistant to heat and collisions PSU They can be cleaned with a detergent having medium alkaline level but no active chlorine To disinfect the handpieces we recommend to use alcohol or aldehyde based products The disinfectants must be approved by the manufacturer for use on the polysulfone PSU Before sterilizing rinse the handpieces The handpieces can bear about 300 steam sterilization cycles if the following instructions are respected steam sterilization ata121 C 1 3bar from 25 to 30 minutes or steam sterilization at a134 C 2 3bar 4 minutes Put the handpieces upright with downward open side Do not exceed the sterilization temperature of 134 C Avoid contact of the handpieces with other objects when disinfecting Each device in time is subject to some wear and tear The safety and working of the device must then be checked in the inspection and maintenance intervals Instruction manual for M U _010_GB 19 01 10 use and inst
21. ng on the screws of the brakes Horizontal arm brakes Use a 2 5 hexagonal wrench 7 to increase the braking force rotating the arm brake dowels 6 clockwise Instruction manual for M _010_GB 19 01 10 use and installation Rev 0 a Page 28 of 8 3 Search for failure n Problem Solution The lamp does not keep the position Check the leveling of the plate installed on the wall wall of the shank to the base floor of the pipe anchored to the ceiling ceiling Tighten the brakes to the articulations in order to increase the frictions 2 The lamp does not work Check the presence of the fuses inside the terminal box T1A the hooking of the electrical connectors Check the presence of voltage in the lamp head 3 The fuse keeps burning Check the characteristics of the fuses inserted 4 The lamp flickers Contact the service center The light beam on the operating field 5 is not on focus faulty meeting of the light fields through handle rotation Contact the service center 6 The lamp does not turn on Check the power supply voltage and fuses Electronics are damaged contact the service center 8 4 Spare part list Description Order code Sterilizable handle Z180045 Electronic card PENTALED 12 Z300617 Membrane keyboard Z300220 Instruction manual for M U _010_GB 19 01 10 a
22. o the lamp bodies and the support arm system Clean the lamp with a damp but not wet cloth 7 2 Disinfection WARNING Electric shock danger WARNING ATTENTION Turn off the lamp by the master switch of the operating room and make sure it does not turn on again in the case of floor versions remove the power supply plug from the electric system socket protect the device against water sprinkling and do not clean disinfect it with liquids Let the lamp body cool down Disinfect the lamp body only when it is cold Use alcohol or aldehyde based products Disinfectants may contain substances harmful to the health use disinfectants only respecting the health standards fixed by the hospital the device keeper must respect the requisites imposed by the national competent hygiene and disinfection commission To avoid damage to stainless steel aluminum parts only use disinfectants with no chlorine or halogens to prevent plastic parts from becoming fragile only use low alcohol disinfectants proportion the detergents so that so that no liquids seep into the lamp bodies and the support arm system Clean the lamp with a damp but not wet cloth Instruction manual for M U _010_GB 19 01 10 use and installation Rev 0 F TECNO GAZ qy 7 3 Sterilizing the handpieces A WARNING Danger for the patient Replace the handpieces as soon as they show cracks or deformations since they
23. on its own responsibility that the Medical Illumination Device for surgical and diagnostic use PENTALED 12 APPLICARE ETICHETTA constructed by TECNO GAZ SPA conforms to the Attachment VII of the 93 42 EEC Directive of June 14 1993 and applied in Italy by the Legislative Decree N 46 of February 24 1997 and successive variances moreover it is in conformity with the following safety regulation EN 60601 2 44 Classification with reference to article 9 and Attachment IX of the 93 42 CEE Directive DESCRIPTION Non invasive Medical Device Par 1 Definition art 1 paragraph 1 2 attachment IX Active Medical Device art 1 paragraph 1 4 attachment IX CLASS Par 3 Classification art 1 paragraph 1 1 Rule 1 attachment IX Name Paolo Bertozzi Position Managing Director Sala Baganza 18 07 2006 a CNO GAZ Instruction manual for Mlu_o10_GB 19 01 10 Uy use and installation Rev 0 Page 5 of 31 Table of Contents 1 Generaliinformation i238 accel eee ea cee ee ede 7 1 1 Users qualification 53s iat clade andt ec aedacnde dnb enen dadetncecedtmanandaes 7 1 2 Packaging transport storage and characteristics of the installation Sie ce faethe hae aS Pare Sie ae tha eh Rar a hae ott eh tke 7 1 3 Graphic symbols used in this installation manual cceeeeeeees 8 1 4 Graphic symbols used on the package cceeeeeeeeeeeeeeeeeeeeeneees 9 1 5 Other gr
24. our tighten the anchor tie rods again with the tightening torque prescribed Chemical anchorage fix the tiges with n 8 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 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 TECNO GAZ Uy Instruction manual for M U _010_GB 19 01 10 use and installation Rev 0 bare Clay cement mix DANGER DANGER In this case it is compulsory to enclose the slab sandwich like by the lamp 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 Before installing the scialytic lamp check the following conditions the electrical system of the installation site must comply
25. ping inside the threaded bush 9 present on the electric panel support TECNO GAZ Uy Instruction manual for M U _010_GB 19 01 10 use and installation Rev 0 fo a A WARNING Irreparable damage to the device ATTENTION 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 lamp Advance insertion may cause irreparable damage to the light source If the product is not used for long periods remove the fuses 4 4 First switch on Before supplying the lamp with voltage remove the protection film from the head screen surface and from the floor base cover Now it is possible to power the lamp to make sure it gives out light To do so you must 1 close the system circuit by means of the head system switch customer s responsibility 2 press the green switch on the base cover floor version 3 press the I O keyboard TECNO GAZ Up Instruction manual for MIU 010_GB 19 01 10 use and installation Revo eee 4 5 Installation check and scialytic lamp testing operations before use ATTENTION The following notes are to be considered compulsory during the installation check as they prove the correct verification of all the points set out For such reason every single point must be ticked when it is treated 1 Make sure the ce
26. r variations For safety reasons all structural changes or variations made in the device on one s own initiative are forbidden In case of similar changes or transformations the warranty of the producer for this device is annulled This way the producer does not assure any warranty for damage or injuries caused by structural changes or variations made in the device on one s own initiative or by the use of non original spare parts Using spare parts not provided by Tecno Gaz or its representatives implies annulment of the warranty TECNO GAZ Uy Instruction manual for M U _010_GB 19 01 10 use and installation Rev 0 ae Life end disposal NOTE DANGER DANGER ATTENTION 2 5 Disposal after use The used device contains valuable materials which can be reused Dispose of the used device respecting the environment and in accordance with the national waste disposal directives in force 3 Mechanical and electrical arrangement of the site 3 1 Mechanical arrangement of the site The building and electrical arrangement works for the installation of the product are the responsibility of the Final Customer 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 following professionals Building Engineer Surveyor Building Contractor du
27. structions and has been commissioned regularly by the authorized installer Tecno Gaz original parts only are used for service repair and structural variation operations and as accessories 5 4 Other safety conditions Secondary effects Do not look frontally inside the lamp when it is on and do not insert reflecting objects into the path of the rays Considering the high lighting power there is strong dazzling danger Do not lay any object on the body of the lamp or hang objects on the arm or the body of the lamp since a safe positioning is no longer ensured and suc objects may fall on the operation area The load of heavy objects body weight of a human being can damage the mechanics During working the head of the lamp must not be covered since it would prevent the thermal exchange with the environment and cause overheating of the lamp Collisions of the mobile arms and the lamp body must be avoided In case of violent collision the lamps may be damaged or pieces of paint may chip and fall on the operating field in the patient area 6 Lamp description and operation 6 1 Description of the device The PENTALED 12 scialytic lamp is available in the following versions floor ceiling FLOOR 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 horizont
28. tion Rev 0 Page 7 of 31 1 General information 1 1 User s qualification Personnel s qualification The following scheme describes in chronological order the life of the Installation Use Ordinary maintenance Extraordinary maint Service Cleaning Demolition DANGER Packaging Transport Storage scialytic lamp and the qualifications required by Tecno Gaz Tecno Gaz or Qualified Installer Qualified authorized medical personnel Tecno Gaz or maintenance by the qualified technical body Tecno Gaz or Qualified Maintenance Technician Tecno Gaz or Authorized Retailer Duly trained personnel Tecno Gaz Qualified Installer or Maintenance Technician Tecno Gaz refuses all responsibility for any damage to people or things deriving from the use of the product by non qualified operators By qualified Installer Maintenance Technician we mean the person s who has have attended a course at Tecno Gaz or read this manual carefully and as confirmation thereof the warranty coupon attached must have been sent back 1 2 Packaging transport storage and characteristics of the installation site 1 box containing a complete scialytic lamp with installation instruction manual and user s manual Transport is carried out by any road haulage contractor as long as they respect the following characteristics Temperature C 15 60 Humidity 10 75 Atmospheric pressure h Pa 500 1060 The devices packaged must b
29. tions 12 For the interventions the buyer must apply to the retailer only or the Replacing components Non return Returns Repairs service centers as recommended by Tecno Gaz 13 The components replaced under guarantee must be returned to Tecno Gaz carriage free 14 The non return implies the charge of the cost of the part to the applicant 15 Tecno Gaz does not accept returns by final users 16 The returns to Tecno Gaz for repair must be managed by the retailer or the service center chosen by the final user according to the commercial procedure CM P 003 called MANAGEMENT OF REQUEST FOR RESTITUTION REPAIRING REPLACEMENT OF TECNO GAZ EQUIPMENT AND CLIENT COMPLAINTS Authorization for returns 17 The returns to RIMSA must be documented and authorized as per Technical documents Return dispatch Non responsibility internal procedures 18 The products returning to Tecno Gaz must be attached with the return authorization documents and a document describing the failure 19 All products under repair must be sent to Tecno Gaz carriage free and suitably packaged it is compulsory to use the original package 20 The constructor does not deem himself responsible for the safety reliability and performance of the device if the installation additions settings repairs are not carried out by people authorized in advance by Tecno Gaz the electrical system of the installation site does not comply with the nationa
30. with the goods is considered valid 4 Repair or replacement under guarantee of a part is carried out for well assessed manufacture reasons and at the unchallengeable discretion of Tecno Gaz The warranty does not include personnel s travels packaging and transport charges 5 The warranty does not include components subject to normal wear and tear including but not limited to halogen lamps fuses relays bearings etc 6 The warranty does not include failure and faults due to improper installation failure or defects caused by carelessness negligence abnormal use of the device or other causes not attributable to the constructor interventions due to presumed defects or convenient inspections 7 The right to replace the whole Lamp is not acknowledged 8 The warranty does not grant any indemnity for direct or indirect damage of any nature to people or things due to the inefficiency of the lamp 9 Tecno Gaz can not be held responsible for failure or damage caused by improper use of the product non maintenance or neglect of the basic principles of good maintenance negligence 10 No indemnity is acknowledged for Lamp stop 11 The warranty is lost automatically if the lamp is tampered with repaired or modified by the buyer or third parties not authorized by Tecno Gaz TECNO GAZ Uy Instruction manual for M U _010_GB 19 01 10 use and installation Revo fee Technical interven
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