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13. Technical data

Control unit

SA-430 M

SA-435 M

Supply voltage:

100 – 240 V

Operating voltage:

30 – 32 V DC

Frequency:

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 (height x width x depth):

90 x 140 x 285

Weight:

635 g

685 g

Length handpiece cable:

1.8 m / 3.5 m

Foot control:

S-N2 / S-NW

Содержание piezomed CLASSIC SA-430M

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

Страница 2: ...es 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 36 Drying 37 Inspection maintenance and testing 38 Packaging 39 Sterilization 40 Storage 42 11 Service 43 12 W H accessories and spare parts 45 13 Technical data 47 ...

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: ...ING 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 part not suitable for intracardiac application ...

Страница 5: ...tion 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 ES60601 1 A1 2012 C1 2009 R 2012 A2 2010 R 2012 CAN CSA C22 2 No 60601 1 2008 CSA CAN CSA C22 2 NO 60601 1 2014 25UX Control No 25UX CE marking with identification number of the Notified Body XXXX Ma...

Страница 6: ...ESY 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 structure in accordance with Health Industry Bar Code DataMatrix Code for product information including UDI Unique Device Identification Catalogue number Serial number MEDICAL GENERAL MEDICAL EQUIPM...

Страница 7: ...he 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 may damage the medical device and hence cause risks and hazards for patient user and third parties Qualifications of the user Only suitably qualified medical technical and specialist trained staff m...

Страница 8: ...remises 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 Unauthorized opening of the medical device invalidates all claims under warranty and any other claims Improper use unauthorized assembly modification of or repairs to the control unit or the handpiece with ca...

Страница 9: ...universal 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 packaging Remove the packaging and remove the power supply irrigation tubing set and accessories ...

Страница 10: ...REF 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 SA 435 M REF 30408000 Handpiece SA 40 with 1 8 m cable only for SA 430 M REF 06369001 Nozzle cleaner REF30264000 Foot control S NW REF 30285000 Foot control S N2 REF 06276700 Instrument changer ...

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 instruments fail Never touch the patient and the electrical contacts on the medical device simultaneously Make sure that no computer viruses are transferred to the control unit by an external data medi...

Страница 12: ...re 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 into a power socket with protective contact Disconnect the medical device in dangerous situations from the power supply Pull the power plug power supply out of the socket ...

Страница 13: ...emaker 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 Make appropriate emergency precautions and take immediate action on any signs of ill health Symptoms such as raised heartbeat irregular pulse and dizziness can be signs of a problem with a cardiac pacem...

Страница 14: ...ubing 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 tubing with undamaged packaging Replace the disposable irrigation tubing immediately after every treatment Follow your local and country specific laws directives standards and guidelines for disposal Cha...

Страница 15: ...run 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 malfunctions e g vibrations unusual noise overheating coolant failure or leakage stop the medical device immediately and contact an authorized W H service partner Safety notes ...

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 signal sounds GREEN Press the green button to change the coolant volume in steps of 20 Press and hold the GREEN button to activate the coolant filling function YELLOW Boost function Press and hold the YEL...

Страница 19: ...t 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 Place the medical device on a flat level surface Ensure that the medical device can be disconnected from the power supply at any time ...

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: ...tch 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 power supply before switching on the control unit at the power switch ...

Страница 22: ...pplication 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 coolant filling functions lasts for 15 seconds Press any button on the display or the foot control to stop the coolant filling function ...

Страница 23: ...ion 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 70 D1 85 No bone quality is displayed for under 40 ...

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 Auto Detection if instrument detection fails during treatment The instrument s maximum power setting is shown on the instrument card Auto Detection OFF Auto Detection is deactivated Auto Detection is...

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

Страница 26: ...r 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 Grey Coolant volume set inactive Green Coolant volume set active Implant mode Switch from Piezo mode to Implant mode Piezo mode Switch from Implant mode to Piezo mode ...

Страница 27: ...l 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 Export user settings Change application Activating deactivating Switch only between Implant Piezo mode Change application OFF ...

Страница 28: ...ng 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 plus moving the slider pressing onto the line of the slider at any position ...

Страница 29: ...pears 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 brochure on wh com WARNING FOOT CONTROL Check plug in connection of foot control Check the plug in connection of the dongle WARNING SWITCH COOLANT SUPPLY On the irrigation tubing set set the regulator of ...

Страница 30: ...n 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 handpiece Allow handpiece to cool for at least 10 minutes SYSTEM ERROR Switch the control unit off and back on again If the error message appears again contact an authorized service partner immediately ...

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 disinfectants which have been tested and found effective by for example the Verbund für Angewandte Hygiene e V VAH Association for Applied Hygiene the Österreichischen Gesellschaft für Hygiene Mikrobio...

Страница 32: ...tly 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 H service partner Processing cycles We recommend a regular service for the W H universal support after 500 processing cycles ...

Страница 33: ...use 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 protection and cannot replace the disinfection step after cleaning ...

Страница 34: ...in 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 residues using compressed air Control unit Do not immerse the medical device in water or clean it under running water Manual cleaning ...

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 Schülke Mayr GmbH Norderstedt and CaviWipes Metrex Hygiene and maintenance Manual disinfection ...

Страница 36: ...t 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 independent test laboratory using the Miele PG 8582 CD washer disinfector Miele Cie KG Gütersloh and the Dr Weigert neodisher MediClean forte cleaning agent Dr Weigert GmbH Co KG Hamburg according to ISO 158...

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: ...pport 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 support following cleaning and disinfection Inspection maintenance and testing ...

Страница 39: ...e 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 ...

Страница 40: ...rers 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 cycle type S 134 C 273 F for at least 3 minutes 132 C 270 F for at least 4 minutes Gravity displacement cycle type N 121 C 250 F for at least 30 minutes Maximum sterilization temperature 135 C 275 F Ster...

Страница 41: ...S09S273 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 270 F 4 minutes Gravity displacement cycle type N 121 C 250 F 30 minutes Drying times Dynamic air removal prevacuum cycle type B 132 C 270 F 30 minutes Steam flush pressure pulse cycle type S 132 C 2...

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: ...tion 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 medical device and must only be performed by an authorized service partner ...

Страница 44: ...mmediately 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 processed before returning it Always return equipment in the original packaging ...

Страница 45: ...www 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 clips 30408000 Handpiece SA 40 with 1 8 m cable incl 5 clips 30285000 Foot control S N2 30264000 Foot control S NW 04019000 Clips 5 pcs 06205600 LED socket ...

Страница 46: ...le 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 set 3 8 m incl Y manifold 6 pcs disposable item ...

Страница 47: ...ency 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 height x width x depth 90 x 140 x 285 Weight 635 g 685 g Length handpiece cable 1 8 m 3 5 m Foot control S N2 S NW ...

Страница 48: ...ity 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 Overvoltage category II Altitude up to 3 000 m above sea level Type B applied part not suitable for intracardiac application Class I medical electrical equipment to avoid the risk of electric shock the p...

Страница 49: ...user 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 energy only for its internal functions Therefore its RF emissions are very low and not likely to cause any interference in nearby electronic equipment No special precautions are necessary to maintain the ...

Страница 50: ...e 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 of this medical device adjacent to or stacked with other equipment should be avoided because it could result in improper operation If such use is necessary this medical device and the other equipment...

Страница 51: ...gnetic 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 to electromagnetic interference Electrostatic discharge ESD IEC EN 61000 4 2 Contact discharge 8 kV Air discharge 2 kV 4 kV 8 kV 15 kV Radiated RF electromagnetic field IEC EN 61000 4 3 80 MHz 2 7 G...

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 by RF fields IEC EN 61000 4 6 3 V 6 V in ISM bands 6 V in amateur radio bands Power frequency magnetic field EN 61000 4 8 30 A m Voltage dips voltage interruptions IEC EN 61000 4 11 There are no devia...

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 Packaging ...

Страница 54: ...e 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 practice department with address Signature of the user The signature confirms that the user has been trained to use the medical device and has understood the content Name of the instructor Date of i...

Страница 55: ...ice 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 address Signature of the user The signature confirms that the user has been trained to use the medical device and has understood the content Name of the instructor Date of instruction Address of the ...

Страница 56: ......

Страница 57: ...or 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 covered by the warranty We accept no responsibility for damage caused by incorrect handling or by repairs carried out by third parties not authorized to do so by W H Claims under warranty accompanied by ...

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 Bürmoos GmbH Ignaz Glaser Straße 53 5111 Bürmoos 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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