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W&H piezomed PLUS SA-435 M, Instructions For Use Manual

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W&H piezomed PLUS SA-435 M Instructions For Use Manual Download Page 3

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Contents

14. Data on electromagnetic compatibility according to IEC/EN 60601-1-2

.......................................................................................... 49

15. Disposal

 ................................................................................................................................................................................................. 53

W&H course certificate

 ............................................................................................................................................................................... 54

Explanation of warranty terms

 ................................................................................................................................................................... 57

Authorized W&H service partners

 .............................................................................................................................................................. 58

Summary of Contents for piezomed PLUS SA-435 M

Page 1: ...Instructions for Use SA 435 M SA 430 M...

Page 2: ...s 29 10 Hygiene and maintenance 31 General notes 31 Limitations on processing 32 Initial treatment at the point of use 33 Manual cleaning 34 Manual disinfection 35 Automated cleaning and disinfection...

Page 3: ...3 Contents 14 Data on electromagnetic compatibility according to IEC EN 60601 1 2 49 15 Disposal 53 W H course certificate 54 Explanation of warranty terms 57 Authorized W H service partners 58...

Page 4: ...NG risk of injury ATTENTION to prevent damage occurring General explanations without risk to persons or objects Sterilizable up to the stated temperature Thermo washer disinfectable Type B applied par...

Page 5: ...ion Foot control Do not dispose of with domestic waste MEDICAL GENERAL MEDICAL EQUIPMENT AS TO ELECTRICAL SHOCK FIRE AND MECHANICAL HAZARDS ONLY IN ACCORDANCE WITH ANSI AAMI ES 60601 1 2005 ANSI AAMI...

Page 6: ...SY OfW GmbH for identification of recyclable transport and outer packaging of paper and cardboard 40 C 40 F Min 70 C 158 F Max 8 80 CE marking with identification number of the Notified Body XXXX Data...

Page 7: ...e safety notes Intended use Drive unit with a piezoceramic oscillating system for treatment of organic hard and soft tissue in dental surgery implantology maxillofacial surgery and periodontics Misuse...

Page 8: ...emises must comply with the regulations laid out in IEC 60364 7 710 Installation of electrical equipment in rooms used for medical purposes or with the regulations applicable in your country Unauthori...

Page 9: ...niversal support control unit and mains cable W H packaging is environmentally friendly and can be disposed of by industrial recycling companies However we recommend that you keep the original packagi...

Page 10: ...EF 08067690 Stand X Mains cable country specific X Optional included in set REF 30392000 Handpiece SA 40 L with 1 8 m cable only for SA 435 M REF 30392001 Handpiece SA 40 L with 3 5 m cable only for S...

Page 11: ...overheating at the treatment site The responsibility for the use and timely shutdown of the system lies with the user Ensure that it is possible to complete the operation safely should the units or in...

Page 12: ...e activated on power up System failure A total system failure does not constitute a critical fault Mains cable Power supply Only use the power mains cable supply supplied Plug the mains cable only int...

Page 13: ...maker or ICD of at least 40 cm 15 75 inch is maintained Find out if patient or user have implanted systems before using the medical device and consider the application Weigh the risks and benefits Mak...

Page 14: ...bing set or accessories approved by W H Irrigation tubing set Sterile disposable irrigation tubing sets are supplied with the equipment Note the expiration date and only use disposable irrigation tubi...

Page 15: ...un Do not hold the handpiece with cable at eye level Attach the handpiece with cable to the control unit Insert the instrument Put the control unit into operation In the event of operating malfunction...

Page 16: ...16 5 Description Connection for handpiece Stand holder SA 430 M SA 435 M Connection for foot control Connection for power supply Connection cable...

Page 17: ...17 Description ORANGE Locator attach detach GREEN GREY Start motor pedal VARIABLE or ON OFF Factory setting ON OFF YELLOW foot control S N2 S NW...

Page 18: ...button for 3 seconds S NW Change application Press the ORANGE button for 3 seconds until an acoustic signal sounds S N2 Change application Press the ORANGE button for 3 seconds until an acoustic signa...

Page 19: ...the power supply foot control or dongle to the SA 4xx M Pay attention to the positioning Connect handpiece cable Pay attention to the positioning Insert the stand Pay attention to the positioning Pla...

Page 20: ...20 Start up Insert the irrigation tubing Open the pump cover a b Insert the irrigation tubing c Close the pump cover d Attach the universal support and lock it...

Page 21: ...ch on off the control unit at the power switch Pull the power plug out of the socket Start up Control unit switching on and off SA 430 M SA 435 M Ensure that the SA 430 M SA 435 M is connected to the...

Page 22: ...plication The coolant filling function symbol will only appear on the display if a handpiece is connected Coolant filling function Start the coolant filling function by confirming the entry The coolan...

Page 23: ...on Coolant volume Foot control Power Instrument group Information 7 Operation Main menu Bone quality In instrument group 3 the power settings are displayed according to bone quality D1 D2 D3 D3 40 D2...

Page 24: ...instruments is only available with Auto Detection and displays all available instruments Auto Detection Instrument detection assists the user and helps to avoid incorrect settings Only deactivate the...

Page 25: ...25 Operation Navigation Only visible when using the foot control S NW Visible in Piezo mode visible in Implant mode...

Page 26: ...Confirm save Switch to next screen Foot control ON OFF Screen lock Activating deactivating Set screen lock Activating deactivating Interval Interval time Select time System Coolant filling function G...

Page 27: ...Public License LGPL GNU Lesser General Public License Module info Service Device info Icons Auto detection Activating deactivating Auto detection OFF Software Update Reset Reset Import user settings...

Page 28: ...g selected red error message work cannot be continued orange error message work can be continued red replace batteries Foot control S NW Foot control S N2 Reduce increase parameters pressing minus plu...

Page 29: ...ears again contact an authorized W H service partner immediately WARNING AUTO DETECTION OFF Manually enter the instrument group Use the group number from the instrument card or from the Piezomed broch...

Page 30: ...Icon Description of error Solution WARNING INSTRUMENT DETECTION ERROR Check LED socket correctly attached defective Deactivate AUTO DETECTION WARNING SURGERY SCALER Check the plug contacts of the han...

Page 31: ...for cleaning and or disinfecting medical devices made of metal and plastic It is imperative to comply with the concentrations and exposure times specified by the manufacturer of the disinfectant Use d...

Page 32: ...ly are mainly determined by mechanical stress during use and chemical influences due to processing Send worn or damaged medical devices and or medical devices with material changes to an authorized W...

Page 33: ...se Clean the medical device immediately after every treatment Wipe the universal support and the stand with disinfectant Note that the disinfectant used during pre treatment is only for personal prote...

Page 34: ...n an ultrasonic bath Universal support Stand Clean the universal support and the stand under running tap water 35 C 95 F Rinse and brush off all internal and external surfaces Remove any liquid residu...

Page 35: ...of the basic suitability of the universal support and the stand for effective manual disinfection was provided by an independent test laboratory using the disinfectants mikrozid AF wipes Sch lke Mayr...

Page 36: ...control are not approved for automated cleaning and disinfection Evidence of the basic suitability the universal support and the stand for effective automated disinfection was provided by an independ...

Page 37: ...37 Hygiene and maintenance Universal support Stand Ensure that the universal support and the stand are completely dry after cleaning and disinfection Remove liquid residues using compressed air Drying...

Page 38: ...port and the stand after cleaning and disinfection for damage visible residual soiling and surface changes Reprocess any universal support and stand that are still soiled Sterilize the universal suppo...

Page 39: ...following requirements The sterilization procedure must meet the applicable standards in respect of quality and use and must be suitable for the sterilization method The sterilization package must be...

Page 40: ...ers of steam sterilizers The program selected must be suitable for the universal support Recommended sterilization procedures Dynamic air removal prevacuum cycle type B Steam flush pressure pulse cycl...

Page 41: ...09S273 steam sterilizer CertoClav GmbH Traun Dynamic air removal prevacuum cycle type B 134 C 273 F 3 minutes 132 C 270 F 4 minutes Steam flush pressure pulse cycle type S 134 C 273 F 3 minutes 132 C...

Page 42: ...42 Universal support Store sterile goods dust free and dry The shelf life of the sterile goods depends on the storage conditions and type of packaging Hygiene and maintenance Storage...

Page 43: ...ion and safety of the medical device is necessary and should be carried out at least once every three years unless shorter intervals are prescribed by law The periodic inspection covers the complete m...

Page 44: ...mediately contact an authorized W H service partner Repairs and maintenance work must only be undertaken by an authorized W H service partner Ensure that the medical device has been completely process...

Page 45: ...ww wh com 07945930 Transportation case 04653500 Handle for foot control 07172900 Cassette 30392000 Handpiece SA 40 L with 1 8 m cable incl 5 clips 30392001 Handpiece SA 40 L with 3 5 m cable incl 10 c...

Page 46: ...e cleaner 07721800 Universal support 08067690 Stand 07883900 Power supply 07233500 W H Adapter kit 08072750 Irrigation tubing set 2 2 m incl Y manifold 6 pcs disposable item 08041710 Irrigation tubing...

Page 47: ...ncy 50 60 Hz Maximum power output ultrasonic 18 W 24 W Operating frequency 22 35 kHz Coolant flow rate at 100 at least 50 ml min Operating mode S3 80s on 330s off maximum 4 repeats Dimensions in mm he...

Page 48: ...ty during storage and transport 8 to 80 relative non condensing Temperature during operation 10 C to 35 C 50 F to 95 F Humidity during operation 15 to 80 relative non condensing Pollution level 2 Over...

Page 49: ...ser should assure that this medical device is set up and used in an environment of the specified type and or in accordance with the specifications of the manufacturer This medical device uses RF energ...

Page 50: ...parts The use of accessories and spare parts not approved by W H can lead to an increased emission of electromagnetic interference or to a reduced resistance against electromagnetic interference Use...

Page 51: ...netic radiation disturbance Radiated Emissions CISPR 11 EN 55011 30 MHz 1000 MHz Group 1 Class B Harmonic distortion IEC EN 61000 3 2 Class A Voltage fluctuations and flicker IEC EN 61000 3 3 Immunity...

Page 52: ...m 2450 MHz 28 V m 5240 5500 5785 MHz 9 V m Electrical fast transient burst IEC EN 61000 4 4 Electrical cables Input and output cables 2 kV 1 kV Surges IEC EN 61000 4 5 Conducted disturbances induced b...

Page 53: ...15 Disposal Ensure that the parts are not contaminated on disposal Follow your local and national laws directives standards and guidelines for disposal Medical device Waste electrical equipment Packag...

Page 54: ...and maintenance and service regular inspections Product name Serial number SN Manufacturer with address Distributor with address Name of the user Date of birth and or personnel number Hospital dental...

Page 55: ...ce regular inspections Product name Serial number SN Manufacturer with address Distributor with address Name of the user Date of birth and or personnel number Hospital dental practice department with...

Page 56: ......

Page 57: ...r manufacturing defects within a warranty period of 12 months from the date of purchase Accessories and consumables cassette irrigation tubing set clips nozzle cleaner O rings adaptor set are not cove...

Page 58: ...58 Authorized W H service partners Find your nearest authorized W H service partner at http wh com Simply go to the menu option Service for full details Or simply scan the QR code...

Page 59: ......

Page 60: ...Manufacturer W H Dentalwerk B rmoos GmbH Ignaz Glaser Stra e 53 5111 B rmoos Austria t 43 6274 6236 0 f 43 6274 6236 55 office wh com wh com Form Nr 51029 AEN Rev 004 27 09 2021 Subject to alterations...

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