Tecnomed Italia Skudo Скачать руководство пользователя страница 28 | Manualshive

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Tecnomed Italia Skudo Скачать руководство пользователя страница 28

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ENGLISH

17 - DECLARATION OF CONFORMITY

EC DECLARATION OF CONFORMITY 93/42/EEC

MODEL:SKUDO™

Tecnomed Italia Srl declares, under its own responsibility, that the Class I medical device

described below
Model: SKUDO™

Code:DP2003S

Progressive number:__________________

to which this declaration refers:

complies with the Essential Requirements (annex 1) and the provisions of the Directives

93/42/EEC transposed by means of Legislative Decree46/97 and 2007/47/CE transposed

by means of Legislative Decree37/10, and is subject to the procedures laid down in Annex

XII of Directive 93/42 CEE a.m.

_______ / _______ / _______ Castelvecchio di Monte Porzio

Tecnomed Italia srl

Legal Representative

Luca Riccardi

SKUDO™
• Registered trademark:302020000035719

• Patent pending:102020000008218

SKUDO code DP2003S is a Medical Device n.1962368 registered to the Ministry of

Health.

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Содержание Skudo

Страница 1: ...V 8 00 CODE DP2003S Installation operation and maintenance manual Aerosol barrier ...

Страница 2: ...2 ...

Страница 3: ...CERTIFICATIONS 5 3 TECHNICAL FEATURES 5 4 DIMENSIONS 5 5 PACKING LIST 5 6 IDENTIFICATION PLATES 5 7 PRODUCT PROFILE 6 INSTALLATION 6 1 SUPPLY CONNECTION STANDARD INSTALLATION 6 2 SUPPLY CONNECTION FIXED INSTALLATION 7 INSTRUCTIONS FOR USE 8 POSITIONING 9 OPERATION 10 EXTERNAL CLEANING 10 1 RECOMMENDED DISINFECTANT 11 INTERNAL CLEANING 11 1 RECOMMENDED DISINFECTANT 12 MAINTENANCE 13 TROUBLESHOOTING...

Страница 4: ...f contamination due to contact with infected biological fluids or materials GENERAL INFORMATION SYMBOL This symbol indicates a piece of information that allows you to use the device more efficiently DISPOSAL SYMBOL This symbol indicates that the product should not be disposed of like normal waste but it should be recycled as per Directive 2002 95 EC 2002 96 EC and 2003 108 EC STERILISABLE This sym...

Страница 5: ...blication are not binding Tecnomed Italia s r l pursues a policy of continuous product improvement and reserves the right to make changes to the product or to this manual without prior notice as long as said changes do not affect the safe use of the device Keep the manual within reach It is also strictly forbidden any kind of reproduction or appropriation of the text and or images in the manual th...

Страница 6: ...rification after clearly writing down the reason delivery refused accepted subject to verification package with packing tape pulled off delivery refused accepted subject to verification package with visible signs of damage cardboard bent delivery refused accepted subject to verification package extremely damaged and or partially open delivery refused accepted subject to verification 2 Leave the pr...

Страница 7: ...y are 3 Do not use the product If the product is damaged but the packaging presents no visible signs of damage proceed as follows 1 Inform the transport company no later than 30 days after delivery 2 Leave the product and the packaging as they are 3 Do not use the faulty product ATTENTION If the recipient fails to comply with any of the aforementioned provisions the damage shall be considered as i...

Страница 8: ...rer assumes a responsibility similar to that of the manufacturer DANGER Comply with the conditions of use provided in the Technical Specifications chapter and do not exceed the recommended values DANGER Do not use the product with accessories not approved by Tecnomed Italia s r l and without CE marking or fitted with standardised interfaces The patient and the dentist might get injured or the devi...

Страница 9: ...cts authorised by Tecnomed Italia s r l Inappropriate products might damage the surface of the device affect its operation lead to contamination or cause injuries to the patient and or the operator Tecnomed Italia s r l assumes NO responsibility for personal injury and or direct or indirect property damage resulting from non compliance with this requirement For more information see paragraphes Ext...

Страница 10: ...s Use of accessories not authorised by Tecnomed Italia srl If the electrical system available at the installation site does not comply with the application standard and the appropriate requirements Assembly and or repairs carried out by staff not authorised by Tecnomed Italia srl If the storage conditions do not comply with the requirements specified in chapter Transport and storage conditions 5 P...

Страница 11: ... information to be supplied Part 1 General requirements EN ISO 13485 2012 Medical devices Quality management systems EN 62366 2007 Application of Usability engineering to Medical Devices 5 3 TECHNICAL FEATURES Product code DP2003S Head diameter 300 mm Flexible arm length 900 mm Swivel angle 180 Min Max Operating air pressure 4 4 5 bar Air consumption at 4 bar 16 l min Minimum suction depression 18...

Страница 12: ...12 ENGLISH 5 4 DIMENSIONS 5 5 PACKING LIST ...

Страница 13: ...m SKUDO with arm Suction conveyor Suction adapters 17 11 mm Quick male fitting 4 mm tube Quick female fitting 1 8F Instruction manual M6 knob 2 M5 knobs with washers 2 M5x14 stainless steel 4 M5x5 stainless steel 2 M5x10 stainless steel 2 M5x25 stainless steel ...

Страница 14: ...located on the headrest collar Data on the plate Name of the manufacturer Name of the device Product code Serial number Air pressure Suction depression Guide to reading the serial number 1308001 Week of production Progressive number Year of manufacture ...

Страница 15: ...15 ENGLISH 5 7 PRODUCT PROFILE Headrest collar Micro suction input Compressed air outlet Toggle valve Pneumatic unit Flexible arm Pneumatic tube 4 x 0 75 mm Adaptor Suction output Suction unit ...

Страница 16: ... from improper and or lack of cleaning and or maintenance 1 Insert the collar into the headrest rod and secure it using four M5 nuts with different lengths of the 8 supplied 2 R L After listening to the doctor s need screw the arm to the collar with the 2 M5x14 countersunk screws to the right or left If the surgery practice has continuous needs for position inversion fit the two M5 knobs with wash...

Страница 17: ...supplied female quick coupling on the water unit or on the back of the chair Connect it to a 4 bar pneumatic supply NB if necessary install a pressure reducer Cod PV1803MR Insert the male quick coupling on the 4 mm pneumatic supply tube SUCTION Insert the cannula into use ...

Страница 18: ...suction is always used in the oral cavity WARNING If all the dental units of the surgery practice work simultaneously using SKUDO and double suction cannula it is necessary to check the flow rate of the suction system as it could be under sized 2 5X4 mm 4X6 mm TUBO 17 5 mm Cod AS17TB10R TUBO 25 mm Cod 040T990 1 2 3 B A ARIA A B ...

Страница 19: ...d liable for personal injury and or direct or indirect property damage deriving from failure to comply with the instructions in this manual and or from incorrect installation and or use of the device and its accessories and or from improper and or lack of cleaning and or maintenance DANGER The device and its accessories are supplied non sterile At the first use and after each treatment the device ...

Страница 20: ... ends of the arch Breakage hazard Damages attributable to this default are not covered by the warranty SKUDO head should be positioned at a distance of about 20 cm from the face so that the practitioner can work easily in the oral cavity SKUDO creates an invisible barrier that blocks and sucks the aerosols that pass through it or are in the vicinity To facilitate the work at 9 hours it is advisabl...

Страница 21: ...terventions with limited aerosols it is also possible to use the saliva suction cannula using adapter B Move the lever to release the air blade The noise added to that of the suction cannula it only measures 12 decibels more A C B C WATCH THE VIDEO SHOWING THE OPERATION 17 mm 11 mm https vimeo com 421909057 ...

Страница 22: ... phenols or phosphates Tested to VAH DGHM criteria CE 0044 Advanced new combination of active ingredients quaternary ammonium compounds Spectrum of action HBV HIV HCV 1 minute Bactericide fungicide 1 minute Code 60030130 dispenser with 70 wipes 750 ml SK bottle ATTENTION General information in accordance with Standard DIN EN ISO 17664 The product and all the instruments must be cleaned and disinfe...

Страница 23: ...rush dispenser for the disinfection of alcohol sensitive surfaces of medical devices alcohol sensitive surfaces of the treatment centre handles leather imitation leather covers The prolonged effect prevents the establishment of new germs present in the air Free of aldehydes phenols and phosphates Tested according to VAH DGHM criteria CE0044 New advanced combination of active ingredients quaternary...

Страница 24: ...m failure to perform the safety technical controls and maintenance operations The product can be used only if all the technical safety controls had positive result DANGER The technical checks must also be carried out after any changes to the ma chine such as the installation of other components after the first commissioning in order to avoid problems that can affect safety Periodically check and c...

Страница 25: ...djust the pressure reducer so that the value is between 4 and 4 5 bar 4 Use the large surgical cannula There remains liquid sucked into the bottom of the lower arch None Cases within normal range The micro suction sucks aerosol particles and not fluids At the end of the operation dry with disinfectant wipes The lower arch does not suck 1 Blocked suction cannula or suction filter 2 Internal suction...

Страница 26: ...normal waste but it should be sent to the nearest authorised waste collection centre for electrical and electronic equipment Disposal must be carried out in accordance with the applicable environmental regulations for waste disposal The equipment must be properly prepared disinfection sterilisation before dismantling disposal For more information on the treatment recovery and recycling of this pro...

Страница 27: ...s r l technician the power supply connection is incorrectly made or the appropriate safety devices have not been installed the serial number series or CE marking are removed erased or tampered The warranty covers the replacement free of charge of the parts of the device resulting to be defective at the origin due to manufacturing defects The Customer cannot request the replacement of the entire pr...

Страница 28: ... and the provisions of the Directives 93 42 EEC transposed by means of Legislative Decree46 97 and 2007 47 CE transposed by means of Legislative Decree37 10 and is subject to the procedures laid down in Annex XII of Directive 93 42 CEE a m _______ _______ _______ Castelvecchio di Monte Porzio Tecnomed Italia srl Legal Representative Luca Riccardi SKUDO Registered trademark 302020000035719 Patent p...

Страница 29: ...URCHASE NAME OF DEALER DISTRIBUTOR Garanzia Guarantee Garantie Garantía ________ ____ Mesi Months Mois Meses _ Ragione sociale studio Business name Raison sociale Razón social _ Indirizzo Address Adresse Direccion Etichetta prodotto Product label Etiquette produit Etiqueta producto Tecnomed Italia s r l Via Salvador Allende n 2 61040 Castelvecchio di Monte Porzio PU Italy Phone 39 0721 95 51 25 Fa...

Страница 30: ...30 ENGLISH 19 PNEUMATIC TEST Operator code Decibels within the norm No internal air leak No loss of internal depression 4 bar air curtain effective Pass Product label ...

Страница 31: ......

Страница 32: ...32 ENGLISH Tecnomed Italia s r l Via Salvador Allende n 2 61040 Castelvecchio di Monte Porzio PU Italy Phone 39 0721 95 51 25 Fax 39 0721 95 52 29 www dentalastec it ...

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