SAEVO Sonic Duo Скачать руководство пользователя страница 51

Страница: 51 / 68

9.STANDARDS AND REGULATIONS

This equipment has been designed and manufactured to meet the following rules:

ABNT NBR IEC 60601-1:2010

Amendment 1:2016

Medical Electrical Equipment - Part 1: General requirements

for basic security and essential performance.

ABNT NBR IEC 60601-1-2:2017

Medical Electrical Equipment, Part 1-2: General basic

safety requirements and essential performance - Collateral

standard: Electromagnetic interference - Requirements

and tests.

ABNT NBR IEC 80601-1-60:2015

General requirements for basic safety and essential

performance of dental equipment.

ABNT NBR 60601-1-6:2011

Electromedical equipment - Part 1-6: General requirements

for basic safety and essential performance - Collateral

standard: Usability.

ABNT NBR IEC 62366:2010

Health products - Application of usability engineering to

health products.

IEC 60601-1-9:2007+AMD1:2013

Medical electrical equipment - Part 1-9: General

requirements for basic safety and essential performance

- Collateral standard: Requirements for environmentally

conscious design.

IEC 62304:2006

Medical device software - Software lifecycle processes.

ISO 10993-1:2018

Biological assessment of medical devices - Part 1:

Assessment and testing.

ABNT NBR ISO 14971:2009

Medical devices - Application of risk management to

medical devices.

ABNT NBR ISO 13485:2016

Quality management systems - Requirements for

regulatory purposes.

Содержание Sonic Duo

Страница 1: ......

Страница 2: ...2 THIS PAGE IS INTENTIONALLY LEFT BLANK ...

Страница 3: ...onic Sonic Fit Brand Saevo Technical Responsible Daniel R de Camargo CREA SP 5062199650 ANVISA Registration Nº 10069210086 Document originally written in Portuguese Alliage S A Industrias Médico Odontológico Rodovia Abrão Assed Km 53 CEP 14097 500 Ribeirão Preto SP Brazil Phone 55 16 3512 1212 77000000863 Rev 08 Abril 20 ...

Страница 4: ...egistered trademarks or service marks of their respective owners Alliage S A makes no claims regarding these trademarks The use of a term in this manual should not be considered to influence the validity of any trademark registered trademark or service mark Copyright 2019 Alliage S A All rights reserved The performance characteristics provided in this manual are for reference only and should not b...

Страница 5: ...TS 26 3 6 USER INTERFACE 27 3 6 1 Sonic Duo Sonic Duo Fit 27 3 6 2 Sonic 28 3 6 3 Sonic Fit 29 3 7 LABEL POSITIONING 29 3 8 SYSTEM REQUIREMENTS 30 3 8 1 Compressor requirements 30 3 8 2 System layout 30 3 9 EQUIPMENT INSTALLATION 31 04 OPERATION 33 4 1 INITIAL PREPARATION 33 4 1 1 Sonic Duo Sonic Duo Fit 33 4 1 2 Sonic 34 4 1 3 Sonic Fit 34 4 2 USING THE ULTRASOUND 35 4 2 1 Operation 35 4 2 2 Tech...

Страница 6: ...WARRANTY PERIOD 49 09 STANDARDS AND REGULATIONS 51 10 TECHNICAL SPECIFICATIONS 53 10 1 EQUIPMENT CLASSIFICATION 53 10 2 APPLIANCE INFORMATION 53 10 3 SPECIFIC INFORMATION 54 10 4 ULTRASOUND SPECIFICATIONS 55 10 5 ENVIRONMENTAL CONDITIONS 55 10 6 EQUIPMENT DIMENSIONS 56 10 6 1 Sonic Duo 56 10 6 2 Sonic Duo Fit 57 10 6 3 Sonic 58 10 6 4 Sonic Fit 59 11 ELECTROMAGNETIC COMPATIBILITY 61 11 1 GUIDANCE ...

Страница 7: ...7 1 GENERAL INFORMATION Alliage S A Industrias Médico Odontológico Telephone 55 16 3512 1212 Rodovia Abrão Assed Km 53 CEP 14097 500 Ribeirão Preto SP Brazil ...

Страница 8: ...que and residual stains tartar removal periodontal treatment endodontic treatment micro retro surgery cavity preparations for restorations amalgam condensation inlays and on lays and gutta percha removal of pins and crowns among other procedures related to dental treatments 1 3 CONTRAINDICATIONS This equipment is contraindicated for use in patients who have serious respiratory renal or hemodialysi...

Страница 9: ...to a special waste collection site at the end of its useful life Applies to both the device and accessories Attention Electrostatic sensitive devices ESD Protective ground wire General warning Alternating current Serial number Turn Off Power Disconnects from the main switch Mandatory action Turn On Power Connects from the main switch Follow the instructions for use ...

Страница 10: ...del Ultrasound Bicarbonate jet Power Ultrasonic power adjustment knob Air Air flow regulation button Water Water flow regulation button S Scaling function micro retro surgery P Periodontal function periodontics E Endo function endodontics ...

Страница 11: ...11 2 WARNINGS CAUTIONS AND RECOMMENDATIONS Alliage S A Industrias Médico Odontológico Telephone 55 16 3512 1212 Rodovia Abrão Assed Km 53 CEP 14097 500 Ribeirão Preto SP Brazil ...

Страница 12: ...The equipment must be transported and stored observing the following Handle with care to avoid falls excessive vibrations and impacts The arrows on the packaging must be pointing upwards To handle the package as a single unit consider the center of gravity indicator Do not stack above the quantity indicated on the packaging Do not walk or stand above the package Protect against sunlight moisture w...

Страница 13: ...ained in this manual Under no circumstances can the patient operate the equipment The patient must not touch other parts than those specific to be treated The equipment must be operated only by qualified health professionals To operate the equipment operating personnel must Read and understand the user manual Be familiar with the basic structure and functions of this equipment Be familiar with the...

Страница 14: ...nt must be cleaned and disinfected sterilized with each new patient to prevent the transmission of infectious agents that can cause serious illness Perform cleaning and disinfection sterilization according to instructions contained in this manual Do not unplug the cable or other connections unnecessarily Do not modify any part of the equipment If the equipment shows any abnormality check if the pr...

Страница 15: ...s non acute materials that may cause disease or suspicion of harboring pathogenic organisms that must be stored in a yellow bag properly labeled with a biohazard symbol stored in a puncture resistant watertight container until collection and incineration To avoid environmental contamination or improper use of the equipment when it is unusable it must be disposed of in accordance with current legis...

Страница 16: ...16 3 SYSTEM OVERVIEW Alliage S A Industrias Médico Odontológico Telephone 55 16 3512 1212 Rodovia Abrão Assed Km 53 CEP 14097 500 Ribeirão Preto SP Brazil ...

Страница 17: ...equipment to remove the leftover bicarbonate powder Bicarbonate jet interruption system with an anti agglutination module that prevents clogging in the valves It has a contamination free system for feeding the ultrasound pens and the bicarbonate jet through the peristaltic pump with antiseptic liquid water serum or similar The peristaltic system has the function of pulsating the liquid from the re...

Страница 18: ... not being able to present a degree of visual imperfection for reading or seeing and an average degree of impairment of recent memory not being clearly able to perform the activities and functions of the product in a correct manner to the profession The user needs to be a qualified health professional and trained to perform the activities functions frequently used in the application of Dental Prop...

Страница 19: ...e jet 03 Ultrasound function selection key PES 04 Ultrasonic variation regulator 05 Water flow regulator 06 Air flow regulator 07 Bicarbonate jet pen 08 Ultrasound pen 09 Tip support 10 Foot pedal 11 Power input cable 12 Reservoir for peristaltic 13 Bicarbonate container 11 10 07 13 12 01 08 09 02 03 04 05 06 ...

Страница 20: ...onate jet 03 Ultrasound function selection key PES 04 Ultrasonic variation regulator 05 Water flow regulator 06 Air flow regulator 07 Bicarbonate jet pen 08 Ultrasound pen 09 Tip support 10 Foot pedal 11 Power input cable 12 Bicarbonate container 11 10 07 12 01 08 09 02 03 04 05 06 ...

Страница 21: ...02 Ultrasound function selection key PES 03 Ultrasonic variation regulator 04 Water flow regulator 05 Ultrasound pen 06 Tip support 07 Activation pedal 08 Power input cable 09 Reservoir for peristaltic pump 08 07 09 01 05 06 02 03 04 ...

Страница 22: ...22 3 3 4 Sonic Fit 01 Ultrasonic variation regulator 02 Tip support 03 Ultrasound pen 04 Activation pedal 09 04 01 02 03 ...

Страница 23: ... accessories or materials not specified in this manual is the sole responsibility of the user Accessories that accompany the product 01 04 02 03 05 The Sonic Duo Kit consists of 01 Tip Periodontal Supra 1 units 02 Tip Periodontal Sub 2 units 03 Nozzle cleaning needle 1 unit 04 O ring Int Ring 11 17 1 unit 05 O ring Int Ring 12 49 1 unit ...

Страница 24: ...24 Accessories that do not accompany the product 01 07 13 04 10 02 08 14 03 09 15 05 11 06 12 ...

Страница 25: ...pra 08 Tip Retro A3 09 Tip Retro A5 01 Silicone hose 02 AR hose 03 Air tee for connection 04 Transducer cover 05 Power input cable 06 Tips fixing key 10 Tip Retro R3 11 Tip Retro R5 12 Tip Dent C1 13 Tip Dent C2 14 Tip Dent C4 15 Tip Dent C5 16 Tip Dent C6 17 Tip Dent A1 Parts and pieces accompanying the product 01 04 02 03 05 06 ...

Страница 26: ... the patient Type of parts Contact type Contact duration Classification TIPs Removable Mucous membrane Bone structure 60s Type B Transducer cover Bicarbonate Jet Removable Mucous membrane 60s Type B Transducer cover Ultrasound Removable Mucous membrane 60s N A Plastic Covers Fixed Mucous membrane 60s N A ...

Страница 27: ...dicates selected Ultrasound function D Bicarbonate Jet Indicates selected Bicarbonate Jet function E Power Adjustment of ultrasonic power F Water Water flow regulation G Air Air flow regulation H US Mode Selection Selects ultrasound function periodontics endodontics and scaling K Periodontics Indicates selected Periodontics mode J Endodontics Indicates selected Endodontics mode I Scaling Indicates...

Страница 28: ...B Power Adjustment of ultrasonic power C Water Water flow regulation D US Mode Selection Selects ultrasound function periodontics endodontics and scaling G Periodontics Indicates selected Periodontics mode F Endodontics Indicates selected Endodontics mode E Scaling Indicates selected Scaling mode ...

Страница 29: ... on 3 7 LABEL POSITIONING The following figure illustrates the location of the labels on the equipment components Demonstrative image Real dimensions 100 x 63 mm Demonstrative image Real dimensions 50 x 23 mm Demonstrative image Real dimensions diameter 10 mm b c a a b c A Identification label B Security label C Consultation instructions manual a b c ...

Страница 30: ... order to minimize the contamination of the air used in the offices For the safety of the patient the operator and the perfect functioning of the product the installation of the compressor must respect the following recommendations Install a pressure relief device next to the compressor Install an air filter with pressure regulator thus preventing oil moisture and solid particles from entering the...

Страница 31: ...for hydraulic and pneumatic installation Connect the hose to the air inlet 15 and tighten the nut1 Connect the other end of the hose to your air network 80PSI Maximum preferably right after the air inlet in the connection box using the tee for connection1 Connect the power input cable 17 b Procedures for electrical installation Plug the equipment into the outlet and proceed according to the sequen...

Страница 32: ...32 4 OPERATION Alliage S A Industrias Médico Odontológico Telephone 55 16 3512 1212 Rodovia Abrão Assed Km 53 CEP 14097 500 Ribeirão Preto SP Brazil ...

Страница 33: ...uipment from the mains use the general switch 4 1 1 Sonic Duo Sonic Duo Fit To start operating the equipment follow the instructions below 1 Switch on the device by pressing the on off switch a 2 Select the function Ultrasound or Bicarbonate Jet b 3 If the ultrasound function is selected select the operation mode periodontics endodontics and scaling c 4 Operate the pedal d a d B c ...

Страница 34: ... 1 Switch on the device by pressing the on off switch a 2 Select the operation mode periodontics endodontics and scaling c 3 Operate the pedal d 1 Switch on the device by pressing the on off switch a 2 Operate the pedal d d d a c a ...

Страница 35: ...ate tip for the desired operation according to the techniques and application 4 Screw the selected tip onto the handpiece with the aid of the fixation key F and a small tightening 5 Operate the pedal E and position the power selector C according to the sensitivity of the operation 6 Adjust the water flow in the water selector D according to the need We recommend that after use do not leave the han...

Страница 36: ...t however we recommend that the structure of the Tip is not altered by filing or twisting it in the same way the aging of a Tip leads to a change of its original characteristic making it ineffective Any Tip that has been damaged by use or by accidental impact must be replaced 4 3 USE OF THE BICARBONATE JET 4 3 1 Operation The bicarbonate jet removes dark stains from the teeth caused by cigarettes ...

Страница 37: ...te powder unscrew the container H as shown and clean The volume of water and air flow can be regulated according to the need as follows 3 Direct the bicarbonate jet handpiece to a container Ex spit pan sink bowl etc 4 Operate the foot control and adjust the water volume water selector D and air flow air selector E The amount of water in excess will cause a decrease in the effect of the powder due ...

Страница 38: ...inish using the product turn it off using the main switch and remove it from the outlet 21 22 23 4 3 2 Supply of the bicarbonate jet To supply your equipment we recommend the use of Clean Okta sodium bicarbonate Reg ANVISA 80339810002 or one that has similar characteristics Product composition Sodium Bicarbonate 99 6 Silicic Anhydrous Essence 105 microns spherical pattern For more information abou...

Страница 39: ...39 5 CLEANING DISINFECTION AND STERILIZATION Alliage S A Industrias Médico Odontológico Telephone 55 16 3512 1212 Rodovia Abrão Assed Km 53 CEP 14097 500 Ribeirão Preto SP Brazil ...

Страница 40: ...ss of the equipment use foam disinfectant detergent that has active components based on didecyldimethylammonium chloride Apply the disinfectant detergent foam on the surface or on a clean cloth and spread it on the surface to be treated Respect the antimicrobial contact time specified by the manufacturer After application allow to dry Do not rinse Some of the removable parts that come in contact w...

Страница 41: ...must be sterilized only in an autoclave at 135 C with at least 3 minutes of waiting time and pressure of 2 2 bar If these items are autoclaved disinfection by alternative methods is not necessary There is no limit on cycles or application time that the equipment and its parts can tolerate during the cleaning disinfection and or sterilization process following the instructions in this manual 5 2 BI...

Страница 42: ...42 6 TROUBLESHOOTING Alliage S A Industrias Médico Odontológico Telephone 55 16 3512 1212 Rodovia Abrão Assed Km 53 CEP 14097 500 Ribeirão Preto SP Brazil ...

Страница 43: ...t Bicarbonate is missing in the container Blockage at the outlet of the container or at the spout Excess bicarbonate in the con tainer Inadequate jet position Add bicarbonate in the container max 40g Remove the blocked parts with the plunger Remove the excess See item Techniques and ap plications The jet lacks pressure Poor regulation of the air flow Air supply pressure below spe cified Adjust the...

Страница 44: ...44 7 INSPECTION AND MAINTENANCE Alliage S A Industrias Médico Odontológico Telephone 55 16 3512 1212 Rodovia Abrão Assed Km 53 CEP 14097 500 Ribeirão Preto SP Brazil ...

Страница 45: ...on of the main inspection items and recommended frequency In addition to the annual inspection to ensure a long service life and smooth operation of your equipment it is important to carry out preventive maintenance for a maximum period of three 3 years Contact the Alliage Service Department about our periodic review and preventive maintenance program All instructions for using the equipment as in...

Страница 46: ...ds can be changed only by the authorized technician The equipment or any of its parts cannot be maintained or serviced during use with a patient The equipment contains parts under high voltage Risk of electric shock Turn off the main switch before servicing The corrective maintenance that can be performed by the user Ultrasound Bicarbonate Jet Prophylaxis equipment is limited to unblocking the bic...

Страница 47: ...m the spout 21 direct the tip to a suitable location spit sink bowl etc and operate the pedal to make sure that the clog is in the spout 21 b Clean the hole with the plunger 22 inserting it until it crosses completely several times c Replace the hose 20 nozzle 21 If necessary replace the hose 20 d Remove the adapter 23 from the bicarbonate jet tip 24 by unscrewing it counterclockwise and take the ...

Страница 48: ...48 8 WARRANTY Alliage S A Industrias Médico Odontológico Telephone 55 16 3512 1212 Rodovia Abrão Assed Km 53 CEP 14097 500 Ribeirão Preto SP Brazil ...

Страница 49: ... counting from the date of issue of the billing invoice of the customer first owner until the date of installation This warranty applies against defects in parts raw materials and the manufacture of your hardware products In the event of defects occurring and reported during the warranty period replacement parts and labor will be provided to replace items covered by the warranty THE MANUFACTURER I...

Страница 50: ...50 9 STANDARDS AND REGULATIONS Alliage S A Industrias Médico Odontológico Telephone 55 16 3512 1212 Rodovia Abrão Assed Km 53 CEP 14097 500 Ribeirão Preto SP Brazil ...

Страница 51: ... 60601 1 6 2011 Electromedical equipment Part 1 6 General requirements for basic safety and essential performance Collateral standard Usability ABNT NBR IEC 62366 2010 Health products Application of usability engineering to health products IEC 60601 1 9 2007 AMD1 2013 Medical electrical equipment Part 1 9 General requirements for basic safety and essential performance Collateral standard Requireme...

Страница 52: ...52 10 TECHNICAL SPECIFICATIONS Alliage S A Industrias Médico Odontológico Telephone 55 16 3512 1212 Rodovia Abrão Assed Km 53 CEP 14097 500 Ribeirão Preto SP Brazil ...

Страница 53: ...ul penetration of water and particulate material Pedal IP01 Product not protected against harmful penetration of drops in water and particulate material Degree of safety of application in the presence of a flammable anesthetic mixture with air oxygen or nitrous oxide Unsuitable equipment Operation mode Ultrasound Non continuous operation Time on 1 min Time off 4 min Bicarbonate Jet Continuous oper...

Страница 54: ...7 V 2 5A max 220 V Master key Contact resistance maximum of 20 milliohms with application of 1A in VCC Electrical characteristics 10A 120 VAC Insulation resistance minimum of 1 000 megaohms Power consumption 60 VA Momentary Maximum grid impedance 0 2Ω Net weight Sonic Duo 4 kg Sonic 3 4 kg Sonic Duo Fit 3 7 kg Sonic Fit 1 0 Kg Gross weight Sonic Duo 5 kg Sonic 4 4 kg Sonic Duo Fit 4 5 kg Sonic Fit...

Страница 55: ...age ambient temperature range 29ºC to 60ºC Transport and storage relative humidity range 20 to 90 Atmospheric pressure range 500 hPa to 1060 hPa 375 mmHg to 795 mmHg Ambient operating temperature range 10ºC to 40ºC Recommended ambient temperature range 21ºC to 26ºC Operating relative humidity range non condensing 30 to 75 Atmospheric pressure range 700 hPa to 1060 hPa 525 mmHg to 795 mmHg Operatin...

Страница 56: ...56 10 6 EQUIPMENT DIMENSIONS 10 6 1 Sonic Duo ...

Страница 57: ...57 10 6 2 Sonic Duo Fit ...

Страница 58: ...58 10 6 3 Sonic ...

Страница 59: ...59 10 6 4 Sonic Fit ...

Страница 60: ...60 11 ELECTROMAGNETIC COMPATIBILITY Alliage S A Industrias Médico Odontológico Telephone 55 16 3512 1212 Rodovia Abrão Assed Km 53 CEP 14097 500 Ribeirão Preto SP Brazil ...

Страница 61: ...mpliance Electromagnetic Environments guidelines RF emissions CISPR 11 Group 1 The Equipment for Prophylaxis by Ultrasound Bicarbonate Jet uses RF energy only for its internal functions Therefore itsRFemissionsareextremelylow and are unlikely to cause any interference in nearby electronic equipment RF emissions CISPR 11 Class A The Equipment for Prophylaxis by Ultrasound Bicarbonate Jet is suitabl...

Страница 62: ...quency 1 kV 100 kHz repetition frequency Outbreak Line by line IEC 61000 4 5 0 5 kV 1 kV 0 5 kV 1 kV Outbreak Ground line IEC 61000 4 5 0 5 kV 1 kV 2 kV 0 5 kV 1 kV 2 kV C o n d u c t e d d i s o rd e r s induced by RF fields IEC 61000 4 6 3 V 0 15 MHz 80 MHz 6 V in ISM bands between 0 15 MHz and 80 MHz 80 AM at 1 kHz 3 V 0 15 MHz 80 MHz 6 V in ISM bands between 0 15 MHz and 80 MHz 80 AM at 1 kHz ...

Страница 63: ...e m Immunity test level V m 385 380 390 TETRA 400 18 Hz pulse modulation 1 8 0 3 27 450 430 470 GMRS 460 FRS 460 FM deviation of 5 kHz 1kHz sinusoidal 2 0 3 28 710 704 787 Band LTE 13 17 217 Hz pulse modulation 0 2 0 3 9 745 7480 810 800 960 GSM 800 900 TETRA 800 iDEN 820 CDMA 850 Band LTE 5 18 Hz pulse modulation 2 0 3 28 870 930 1720 1700 1990 GSM 1800 CDMA 1900 GSM 1900 DECT Band LTE 1 3 4 25 U...

Страница 64: ... and result in improper operation Portable RF communication equipment including peripherals such as antenna cables and external antennas should not be used within 30 cm of any part of the Sonic Duo Sonic Duo Fit Sonic Sonic Prophylaxis Bicarbonate Jet Equipment Fit including cables specified by the manufacturer Otherwise performance degradation of this equipment may occur To maintain basic safety ...

Страница 65: ...65 ...

Страница 66: ...66 ...

Страница 67: ...67 ...

Страница 68: ...68 ...

Результаты поиска

Содержание Sonic Duo

Отзывы:

Похожие инструкции для Sonic Duo

Бренды по названию

Популярные бренды

SAEVO Sonic Duo, Руководство пользователя

Результаты поиска

Содержание Sonic Duo

Отзывы:

Похожие инструкции для Sonic Duo

Бренды по названию

Популярные бренды