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W&H piezomed PLUS SA-435 M, Инструкция по эксплуатации, Страница: 39 / 60

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39

Hygiene and maintenance

Universal support

Pack the universal support in sterilization packages that meet the 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 large enough for the sterilization goods.

 

> The loading sterilization package must not be under tension.

Packaging

Содержание piezomed PLUS SA-435 M

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

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

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

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 56: ......

Страница 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...

Страница 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...

Страница 59: ......

Страница 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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