User Manual
Contents
1. TARO THERMOSEALER SL 13 OPERATING MANUAL REVISIONS The following table lists subsequent editions revisions of the manual The Description field brief explains the subject of the latest revision Code Rev Date Description 97050483 0 09 2011 First issue translation from the original in Italian 97050483 1 04 2012 Text and image adaptation TABLE OF CONTENTS ENGLISH TRANSLATION FROM THE ORIGINAL IN ITALIAN 1 INTRODUDCTION enitn po nia danes 3 1 1 APPLICABLE EUROPEAN DIRECTIVES sse 3 1 2 INTENDED USE iode terr nep oot t ene e a 3 1 3 PURPOSE OF THE MANU AL eet aaa dun 4 1 4 GENERAL 4 2 CONTENTS OF THE nn 5 2 1 DIMENSIONS AND 5 2 2 DESCRIPTION OF THE ITEMS ninaa aa 5 3 PRODUCT PRESENTATION sammen 6 3 1 MAIN PERFORMANCES asasi eiiiai aiina ia 6 3 2 VIEWS 7 4 INSTALLATION eror E ei 8 JE 4 1 GENERAL PRECAUTIONS runs 8 2 4 2 ELECTRICAL CONNECTION sese rrerenr nenne 8 2 4 3 PRODUCT PREPARATION einen 8 LLI 4 4 PAPER ROLL INSTALLATION 444444s00ssnnnnnnnennnnnnennnnnennennnnnnnn nn2. Maintenance The Led does not work Led does not work e LED goce not tasn When thethermosealng Heating resistance broken Contact the Technical Support Service machine is switched on Fault in the electronic card Bag sealing is performed but the LED remains a fixed green instead of red and no acoustic Fault of the end of run microswitch Contact the Technical Support Service signals are heard Insufficient aa 1 in the sealing area Silicon rubber Silicon rubber profile damaged damaged Contact the Technical Support Service Resistance does not reach the operating tem perature Envelope cutting is difficult Consumed blades Contact the Technical Support Service NOTE SHOULD THE PROBLEM PERSIST PLEASE CONTACT OUR TECHNICAL SERVICE NETWORK REPORTING THE THERMO SEALER MODEL AND ITS SERIAL NUMBER THESE DATA CAN BE FOUND ON THE FACTORY PLATE PLACES ON THE UNIT REAR Operator warning signal SIGNAL CAUSE ACTION The LED is flashing green The machine is warming up Wait until the machine warms up The LED is steady green The machine is ready for use fe The sealing lever has been lowered and the Wait for the acoustic signal lift the lever and The LED is fast flashing green ad machine is in use remove the bag The green LED emits a brief flash every 5 se The machine is in a paused status after a pe Lower and lift back up the lever to rest normal conds riod of inactivity of 30 minutes operation The red
3. THE MACHINE HAS COOLED BEFORE ANY MAINTENANCE OPERATION Clean the equipment externally with a clean cloth dampened with water and neuter detergent NOTE DO NOT USE PRODUCTS CONTAINING ISOPROPYL ALCOHOL 2 PROPANOL SO PRoPANOL DO NOT USE PRODUCTS THAT CONTAIN SODIUM HYPOCHLORITE BLEACH DO NOT USE CLEANERS THAT CONTAIN PHENOL Perfectly dry the surfaces and remove any remaining resistant residue Always keep in mind the following general warnings Do not submit the unit to direct water jets under pressure or sprinkling Any infiltration on the internal electrical components could irremediably damage its operation Do not use abrasive sponges metal brushes or other aggressive materials or products for cleaning of metal both solid and liquid The blade must be replaced periodically or when paper cutting problems are noticed Contact technical support The fuses are in the fuse holder above the power lead outlet Remove the power lead plug Remove the fuse holder box with a screwdriver Replace the fuse with one of equal value see appendix A In accordance with Directives 2002 95 EC 2002 96 EC and 2003 108 EC regarding the reduction in use of dangerous substances in electrical and electronic equipment as well as waste disposal such equipment may not be disposed of as normal urban waste and must be separated accordingly When purchasing a new equivalent piece of equipment the old piece
4. 11 De OPERATION ica ana 12 5 1 PREPARATION 12 5 2 PAPER INSERTION essen nennen 12 5 3 WELDING AN END AND CUTTING sse 13 5 4 BAG RETURN AND 1 14 6 PREPARING THE MATERIAL TO BE 15 6 1 MOVING THE MATERIAL sess nennen nennen 15 6 2 CLEANING THE TOOLS sse etre nnne nennen 15 6 3 WRAPPED MATERIAL 15 APPENDIX A TECHNICAL CHARACTERISTICS esses 16 SUMMARY TABLE issue idas 16 SAFETY DEVICES a tete tte e td ak 16 APPENDIX C 17 GENERALS rn Atl 17 CLEANING tata ii a A Rise 17 BLADES REPLACEMENT ui 17 FUSES REPLACEMENT 2 17 APPENDIX TROUBLESHOOTING 18 APPENDIX DECLARATION OF CONFORMITY 19 Cod xxxxxxx rev 0 05 2013 ENGLISH 1 INTRODUCTION 1 1 APPLICABLE EUROPEAN DIRECTIVES 1 2 INTENDED USE Dear Customer thank you for choosing this product We hope it will perform to your full satisfaction This manual describes all procedures for the correct installation and use of the equipment Should you have any questions or suggestions concerni
5. 4 Insert the table area in the appropriate slots 1 ENGLISH 5 Connect the power lead J NOTE ES POSITION THE MACHINE IN SUCH A WAY THAT THE ENDS OF THE CABLE ARE EASILY ACCESSIBLE 6 The thermo sealing machine is now ready for use 10 4 4 PAPER ROLL INSTALLATION Insert the paper roll on the roll holder tube Install the roll holder roll unit on the arm holders as described in the previous paragraph positioned in such a way that the paper belt unrolls downward and with the polypropylene film in view taking care to have the sheet pass under the paper stop barrier Finally fasten the aiming devices ENGLISH 11 5 OPERATION 5 1 PREPARATION 5 2 PAPER INSERTION Verify that the welding lever B is positioned at the highest end of the guide Switch on the machine via the switch A located on the rear part The frontal green LED C will flash Heating resistance is powered and the temperature will increase gradually When the ideal level for proper welding is reached the frontal green LED will remain fixed on emitting an acoustic signal Have the paper belt pass under the paper stop barrier and insert it in the rear slot Then remove it from the front to the desired length see paragraph 5 3 Itis best to pull the paper out to a length equal to that of the tool plus 8 cm to allow proper welding of the edge NOTE BAGS S
6. D BY STATUS IS SIGNALLED BY PERIODIC DOUBLE FLASHING OF THE GREEN LED TO RESET MACHINE OPERATION LOWER AND LIFT BACK UP THE WELDING LEVER THE MACHINE WILL REACTIVATE THE HEATING RESISTANCE FLASHING GREEN LED WAIT FOR THE MACHINE TO HAVE REACHED THE IDEAL TEMPERATURE ONCE AGAIN FIXED GREEN LED BEFORE STARTING USE AGAIN 14 6 PREPARING THE MATERIAL TO BE SEALED 6 1 MOVING THE MATERIAL 6 2 CLEANING THE TOOLS 6 3 WRAPPED MATERIAL The sterilization process can be considered as effective reliable and repeatable on condition that the instru ments and the materials in general are first properly treated and subsequently correctly positioned inside the sterilization chamber This foresight is even more required when we consider objects within an envelope lt must be stressed that organic residue or deposit of substances used in the medical practice inevitably become receptacle of micro organisms and can hamper the steam sterilization process An improper arrangement of the load makes difficult and sometimes impossible the circulation of water steam on the material and or inside its cavities with the consequences that can be imagined Therefore we provide a few basic indications concerning these aspects leaving the customers with the task of improving their knowledge on the matter in the best fashion When handling and moving contaminated material it is good practice to take the following precautions Always wear rubbe
7. E OF DAMAGE IMMEDIATELY PROVIDE A DETAILED DESCRIPTION TO THE RESELLER AND THE TRANSPORTER THAT MADE THE DELIVERY NOTE KEEP THE ORIGINAL PACKAGING AND USE IT WHENEVER THE DEVICE IS TO BE TRANSPORTED THE USE OF DIFFERENT PACKAGING COULD DAMAGE THE PRODUCT DURING SHIPMENT Paper stop barrier 2 screws 4 aiming devices Allen wrench Roll holder tube 2 roll supports Operator documentation SL 13 Thermo sealing machine AN DA A OMN Table area Power lead c O 2 fuses NOTE ENGLISH THE CUSTOMER MUST KEEP THE WARRANTY CERTIFICATE TOGETHER WITH THE RECEIPT m 2 0 0 3 3 1 PRODUCT PRESENTATION MAIN PERFORMANCES SL 13 is the thermo sealing machine which fits as a natural complement to the range of steam sterilisers It is an elegantly space saving designed piece of equipment that is both user friendly and reliability even with heavy use SL 13 is therefore a useful option for all those users who require professional equipment with an excellent ratio of quality to price and performance SL 13 is an electronically controlled thermo sealer with a sealing band of 12 mm fit to resist the sterilization processes of the modern sterilizers featuring fractioned pre vacuum and to assure in time the sterility of the packages Efficient heat control in the welding area is achieved thanks to the automatic temperature adjustment en suring high and constant performa
8. ENTS RELATED TO THE INSTALLATION AND USE OF THIS PRODUCT THE MANUFACTURER WILL NOT BE RESPONSIBLE FOR ANY BREAKAGE MALFUNCTIONS PROPERTY DAMAGE OR INJURY IN THE EVENT THAT THE PRODUCT IS NOT INSTALLED OR USED CORRECTLY Please observe the following precautions in order to avoid injury or property damage in particular Use ONLY recommended cleaning detergents Do not pour water or other liquids or inflammable products on the equipment Do not use the equipment in the presence of gas or explosive or inflammable vapors m Z 0 0 DANGER BEFORE CARRYING OUT ANY MAINTENANCE OPERATION ALWAYS DISCONNECT THE POWER CABLE PLUG FROM THE POWER SOCKET Make sure the electrical system is grounded conforming to current laws and or standards Do not remove any label or nameplate from the device request new ones if necessary Use only original replacement parts WARNING N THE FAILURE TO OBSERVE THE ABOVE RELEASES THE MANUFACTURER FROM ALL LIABILITY 2 CONTENTS OF THE PACKAGE 2 1 DIMENSIONS AND WEIGHT 2 2 DESCRIPTION OF THE ITEMS in NOTE CHECK THE INTEGRITY OF THE PACKAGE UPON RECEIPT Once the package is opened check that the supply matches the specifications of the order see the accompanying document that there is no obvious product damage Size and weight SL 13 wit NOTE T 260 600 I EN IN THE CASE OF A WRONG PRODUCT MISSING PARTS OR ANY TYP
9. HORTER THAN 7 CM ARE NOT RECOMMENDED 12 5 3 WELDING AN END AND CUTTING Lower the lever B from position 1 to position 2 The green LED C will flash quickly until welding has finished indicated by an acoustic signal Slide the cutting lever D to the opposite end Lift the lever B from position 2 to the original position 1 The frontal LED will return to a fixed green once again and the acoustic signal will switch off The bag is now sealed on one end ENGLISH NOTE IF THE LEVER DOES NOT LIFT AFTER A FIRST ACOUSTIC SIGNAL THE SEALING MACHI NE WILL EMIT ANOTHER TONE AND THE LED WILL FLASH RED DANGER DO NOT PUT FINGERS IN THE WELDING AREA WHEN THE MACHINE IS ON AND IMME DIATELY AFTER IT HAS BEEN SWITCHED OFF DANGER DO NOT PUT FINGERS IN THE CUTTING LEVER SLOT DANGER DO NOT LEAVE PAPER INSERTED IN THE SEALING AREA WHEN THE MACHINE IS NOT IN USE 13 5 4 BAG RETURN AND FINISHING Insert the instruments in the open side of the bag following the warnings contained in the chapter Ma terial preparation see following page Insert the unwelded end of the bag in the front slot F a few centimetres until the end of the bag is alig ned with the upper slot G Perform sealing operations as previously described NOTE AFTER A PERIOD OF INACTIVITY OF 30 MINUTES THE MACHINE WILL GO INTO STAND BY MODE SWITCHING OFF THE HEATING RESISTANCE STAN
10. and green LEDs flash at the same time The machine signals the presence of a heating Switch off and retry machine use system problem If the signal recurs contact Technical Support The sealing operation has been completed Lift the lever and remove the bag The LED is solid red and the machine is emitting Ihe the Sealing lever down an acoustic signal The sealing lever was lowered before reaching Lift the lever the proper operating temperature 18
11. checking any incompatibility Meticulously follow the use procedures for detergent or disinfectant products and the instructions for the washing and automatic lubrication equipment The use of sterilization paper envelopes allows both an optimal sterilization and to maintain in time the sterility condition Follow these general indications Envelope the tools one by one or make sure that they are made of the same material Close the envelope with the thermo sealer Do not use metal points pins or similar since they do not warrant sterility Arrange the envelopes so as to avoid the creation of air pockets that prevent the correct penetration and the removal of the steam If possible arrange the envelopes vertically using a suitable support Never overlap the envelopes one over the other 15 ENGLISH APPENDIX A TECHNICAL CHARACTERISTICS FARO S p A Manufacturer Via Faro 15 20876 Ornago MB Italy Temperature 15 C 35 C Operating environment conditions Relative humidity 80 max without conden sation External dimensions without roll L x D x H 474 x 374 x 200 mm Type of sealing With continuous cycle and constant temperature Nominal operating temperature of the heating resi 180 C stance The data plate is placed back on the unit m Z 0 0 SAFETY DEVICES The thermo sealer is equipped with the following safety devices of which we list a short description along with
12. for the operator Do not install in humid or poorly ventilated environments Do not install in environment with the presence of inflammable and or explosive gas or steams Install the unit so that the power supply cable is not bent or pressed along its route up to the mains so cket 4 2 ELECTRICAL CONNECTION In compliance with the standing regulations the unit must be connected to a mains socket of the electrical installation with power rating suitable for the unit consumption and provided with earth connection The socket must be suitably protected upstream by a terminal board provided with electro thermal magnetic switch and differential switch Connect the supplied power cable to the mains socket on the rear of the equipment NOTE ONLY USE THE POWER SUPPLY CABLE PROVIDED WITH THE UNIT POSSIBLE PLUG IS REPLACEMENT IS UNDER THE FULL RESPONSIBILITY OF THE USER DIRECTLY CONNECT THE POWER SUPPLY CABLE TO THE SOCKET DO NOT USE EXTENSIONS ADAPTERS OR OTHER ACCESSORIES m Z e 0 4 3 PRODUCT PREPARATION 1 Carefully remove the package contents 2 Insert the roller supports A in the appropriate holders Tighten the two screws B with the provided Allen wrench C 3 Insert the roll holder tube D in the supports A checking that the holes at the end of the tube properly engage in the teeth E present on the supports A Rest the paper stop barrier F in the compatible holders G
13. g and cutting of sterilization paper polypropylene rolls NOTE THE UNIT CANNOT WORK WITH ROLLS OF A MATERIAL OTHER THAN THE ONES STA TED ABOVE WARNING N THE DEVICE MUST ONLY BE USED BY QUALIFIED PERSONNEL IT MAY NOT BE USED OR HANDLED BY INEXPERT AND OR UNAUTHORIZED PERSONNEL FOR ANY REASON ENGLISH NOTES THE INFORMATION IN THIS MANUAL IS SUBJECT TO CHANGE WITHOUT NOTICE THE MANUFACTURER IS NOT RESPONSIBLE FOR DIRECT INDIRECT ACCIDENTAL OR CONSEQUENTIAL DAMAGES OR ANY OTHER DAMAGES RELATING TO THE PROVISION USE OF THIS INFORMATION NO PART OF THIS DOCUMENT MAY BE REPRODUCED ADAPTED OR TRANSLATED IN ANY FORM OR BY ANY MEANS WITHOUT THE PRIOR WRITTEN PERMISSION OF THE MANUFACTURER FOR CORRECT INTERPRETATION OF THE INSTRUCTIONS CONTAINED IN THIS MA NUAL THE ITALIAN VERSION SHALL BE VALID AS ORIGINAL TEXT 1 3 PURPOSE OF THE MANUAL The manual purpose is to provide instructions for General knowledge of the product Correct installation Its safe and efficient use The treatment of tools and or materials to submit to sterilization More the appendix includes The technical features of the product Maintenance operations Troubleshooting and solutions Other documentation 1 4 GENERAL WARNINGS The product must always be used according to the procedures included in this manual and never for purpo ses other than the ones indicated WARNING THE USER IS RESPONSIBLE FOR ALL LEGAL REQUIREM
14. nce The solid structure in plastic and aluminium and the ergonomic and minimalist shape help to maintain a high level of hygiene weight and overall size and excellent stability during use All this with the objective of offering a product suited to the daily needs in the medical area NOTE FOR THE DESCRIPTION OF THE SECURITY DEVICES REFER TO APPENDIX A TECHNICAL CHARACTERISTICS For a good operation of the thermo sealer the first and essential task is its correct installation in this way possible malfunctions or damages to the unit will be avoided Paper roll for autoclave Cutting handle Roll holder Q zi amp DEPE holders Power lead outlet with fuse Switch 3 2 VIEWS WITH DIMENSIONS 4 INSTALLATION Therefore please read carefully the notes and warnings reported in the rest of this chapter NOTE THE TECHNICAL SERVICE IS AT YOUR DISPOSAL TO CLEAR ANY QUESTIONS OR PROVIDE FURTHER INFORMATION ATTENTION THE ELECTRICAL INSTALLATION MUST BE PROVIDED WITH EARTH CONNECTION 4 1 GENERAL PRECAUTIONS Install the thermo sealer on a flat surface leaving enough room for its operation and adequate ventila tion Makes sure that the resting plane is strong enough to support the unit and roll weight max 15 kg nat install near sinks to avoid contact with water or liquids that could cause short circuits or situations potentially dangerous
15. ng this product or our support do not hesitate to contact us Note warning and danger symbols used through the manual NOTE PAY SPECIAL ATTENTION NOTES FOR PROPER INSTALLATION AND MAINTENANCE PROCEDURES AND USE METHODS WARNING THIS SYMBOL INDICATES A POTENTIAL DANGER OF INJURY FOLLOW THE PROCEDU RES DESCRIBED IN THE MANUAL TO AVOID INJURING THE USER AND O DANGER THIS SYMBOL SIGNALS A POSSIBLE DANGER FOR PEOPLE FOLLOW THE SUGGE STED PROCEDURE IN ORDER TO PREVENT POSSIBLE DAMAGE TO USERS AND OR OTHERS DANGER POTENTIAL HAZARD DUE TO HIGH TEMPERATURE Symbols on equipment N Potential hazard due to high temperature Equipment in accordance with applicable directives Consult the user manual The product described in this manual is manufactured in accordance with the highest safety standards and doesn t represent any danger for the operator if used according to the following instructions The product is in accordance with the following European Directive as applicable 2006 95 EC for the approximation to the legislation of the Members States related to low voltage equip ment 2004 108 EC for the approximation to the legislation of the Members States related to the electromagnetic compatibility Symbol for disposal in accordance with Directive 2002 95 EC 2002 96 EC and 2003 108 EC The unit is meant for professional use and can only be employed for the purpose it was designed for that is the thermo sealin
16. of equipment that has reached its end of life must be handed over to the reseller for proper disposal The Manufacturer will carry out the functions defined by individual national legislation with respect to the reuse recycling and other forms of salvaging of the above mentioned waste The proper collection and separation of such equipment for recycling treatment and disposal helps avoid any possible negative effects on the environment and health and facilitates the recycling of the materials of which the equipment is made The crossed out rubbish can symbol indicates that the product at the end of life must be collected separately from other types of waste WARNING IMPROPER DISPOSAL OF THE PRODUCT RESULTS IN THE APPLICATION OF SANCTIONS WHICH ARE DEFINED BY INDIVIDUAL NATIONAL LAWS 17 ENGLISH m zZ 0 02 als APPENDIX D TROUBLESHOOTING If Your Thermo sealer does not work correctly carry out the following checks before contacting the Technical Service PROBLEM POSSIBLE CAUSE SUGGESTED SOLUTION The plug of the power supply cable is not inser ted inthe outlet Properly put in the plug Lack of power at the power supply outlet Check the possible cause of power failure and try to solve it The thermo sealer does not switch on The magneto thermal switch and or differential Put the switches to ON position switch of the installation are OFF Replace the fuses Mains fuses broken see Appendix C
17. r gloves with adequate thickness Clean with a germicide detergent the hands protected with the gloves Always use a tray for carrying the tools Never carry the tools directly in your hands Pay attention to any sharp or cutting parts to avoid the risk of infections Separate the objects that must not undergo a sterilization or cannot stand the process When you have finished handling the material carefully wash your hands still gloved All materials and or tools to be sterilized must be perfectly cleaned and without trace of any kind of residue organic and inorganic materials paper fragments cotton or gauze swabs scale etc Otherwise the sterilization process could turn out to be not effective and the sterilizer and the tools them selves undergo irreversible damage For an effective cleaning After use immediately rinse the tools with a jet of running water Divide the tools according to the type of material carbon steel stainless steel brass aluminium chrome etc to avoid processes of electrolytic oxidation reduction Carry out a washing with an ultrasonic cleaner containing a mix of water and germicide solution carefully following the manufacturer s recommendations Carefully rinse and check that the cleaning is complete if necessary repeat the washing cycle or clean manually Dry perfectly Before the sterilization check the indications provided by the manufacturer of the tool material
18. their function Mains fuses see data in the above table Equipment protection from internal electrical faults Action break the electrical power supply Automatic off of the heating circuit If the lever is not lifted back up after sealing has been completed the heating circuit will be automatically deactivated This operation will be indicated by an acoustic signal and intermittent red LEDs Anti finger crushing design Protection from accidental crushing of fingers during lever movement Automatic Stand By System After a period of inactivity of 30 minutes the machine will go into stand by mode switching off the hea ting resistance This device protects from risks of overheating caused by a failure to switch off the machine at the end of use creating significant energy conservation at the same time Protected cutting knife Exclusive design with cutting knife totally inaccessible from outside 16 APPENDIX C MANTEINANCE GENERALS CLEANING BLADES REPLACEMENT FUSES REPLACEMENT DISPOSAL AT END OF LIFE The equipment does not need any special care it is only recommended that the user cleans it periodically In all cases carefully follow the procedure detailed below In case of replacement of equipment components request and use ONLY ORIGINAL SPARE PARTS DANGER BEFORE PERFORMING ANY MAINTENANCE OPERATION DISCONNECT THE PLUG OF THE POWER SUPPLY CABLE FROM THE SOCKET ATTENTION MAKE SURE THAT
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