W&H piezomed SA-320 Instructions For Use Manual Download Page 12

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4. Scope of delivery

Control unit

30078000

30078001

30078003

30078004

30078005

30078006

30078007

REF

06985000

Handpiece with 1.8 m cable

REF 07159200

Handpiece with 3.5 m cable

REF 07004400 Foot control S-N1

REF 30264001 Foot control S-NW

REF 07795800

SPI dongle

REF 04653500 Handle for foot control

REF 436360

Irrigation tubing set 2.2 m
(3 pcs, disposable item)

REF 436410

Irrigation tubing set 3.8 m
(3 pcs, disposable item)

REF 07172900

Sterilization cassette

REF 07173100

Instrument set

“

Bone

“

REF 07721800

Universal support

REF 04005900 Stand

REF 06276700

Instrument changer

REF 00636901

Nozzle cleaner

Mains cable country-specific

Summary of Contents for piezomed SA-320

Page 1: ...Instructions for Use SA 320 ...

Page 2: ...anel 19 of rear panel 20 Foot control S N1 S NW 21 Handpiece with cable 23 7 Start up 24 8 Instruments 27 Insert remove 27 9 Setup settings 28 Control unit 28 Foot control S N1 29 Volume 30 Reset factory settings 31 10 Operation 32 Changing the program P1 P3 33 Changing power 34 Changing the coolant flow 35 Changing the operating mode 36 11 Factory settings 37 ...

Page 3: ...5 Manual disinfection 48 Automated cleaning and disinfection 49 Drying 50 Inspection maintenance and testing 51 Packaging 52 Sterilization 53 Storage 55 15 Service 56 16 W H accessories and spare parts 58 17 Technical data 60 18 Disposal 62 W H course certificate 64 Explanation of warranty terms 67 Authorized W H service partners 68 Open Source Software 69 Manufacturer s declaration 70 ...

Page 4: ...age occurring General explanations without risk to persons or objects Sterilizable up to the stated temperature Thermo washer disinfectable in the Instructions for Use Suitable for ultrasonic bath Type B applied part not suitable for intracardiac application ...

Page 5: ...uding UDI Unique Device Identification Foot control Do not dispose of with domestic waste On Off 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 identific...

Page 6: ...ng 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 on the packaging Catalogue number Serial number Manufacturer Date of manufacture MEDICAL GENERAL MEDICAL EQUIPMENT AS TO ELECTRICAL SHOCK FIRE AND MECHANICAL HAZARDS ONLY IN ACCORDANCE WITH ANSI AAMI ES...

Page 7: ...ich the practitioner practices to use or order the use of the device Batch code Not for re use Latex free Use by CE marking with identification number of the Notified Body XXXX on the irrigation tubing set Catalogue number Manufacturer Do not resterilize Do not use when package is damaged Keep away from heat DataMatrix Code for product information including UDI Unique Device Identification Data st...

Page 8: ...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...

Page 9: ...an authorized W H service partner see page 68 The electrical installation at the premises 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 In addition to unauthori...

Page 10: ... HF communications equipment including peripherals such as antenna cables and external antennas should be used no closer than 30 cm 12 inches to the medical device Otherwise degradation of the performance of this medical device could result The medical device may be interfered by other equipment even if these other devices comply with CISPR International special committee on radio interference emi...

Page 11: ...h the control unit Remove the irrigation tubing set Remove the carton containing the accessories supplied 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 sterilization cassette ...

Page 12: ... X X REF 07795800 SPI dongle X X X X REF 04653500 Handle for foot control X X X X REF 436360 Irrigation tubing set 2 2 m 3 pcs disposable item X X X X REF 436410 Irrigation tubing set 3 8 m 3 pcs disposable item X X X REF 07172900 Sterilization cassette X X X X X X REF 07173100 Instrument set Bone X X X X X X REF 07721800 Universal support X REF 04005900 Stand X REF 06276700 Instrument changer X R...

Page 13: ...ly into the light source Avoid overheating at the treatment site Ensure that it is possible to complete the operation safely should the units or instruments fail Only put the handpiece with cable into operation when the handpiece sleeve is attached The responsibility for the use and timely shutdown of the system lies with the user If the LED fails change the LED socket Only change the LED socket w...

Page 14: ...control unit is switched off or when switching between programs the last values set are saved and re activated on power up System failure A total system failure does not constitute a critical fault Mains cable Power switch Only use the mains cable supplied Plug the mains cable only into a power socket with protective contact Set up the control unit so the power switch is easily accessible Disconne...

Page 15: ...t Never touch the instrument when vibrating Remove the instrument from the handpiece after every treatment and place it in the instrument stand provides protection against injury and infection Ensure there is sufficient coolant directly at the treatment site The instruments Z25P and Z35P may only be operated with a coolant setting of max 50 Keep the handpiece moving at all times when operating the...

Page 16: ...ic fields This medical device is suitable for use on patients with unipolar and bipolar pacemakers or ICD if a safety distance between the control unit and the cardiac pacemaker or ICD of at least 30 cm 11 8 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 preca...

Page 17: ...al data and instructions Use the W H irrigation tubing 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 national laws directives ...

Page 18: ...universal support the instruments and the instrument changer Test 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...

Page 19: ...19 6 Description of front panel Shift buttons PLUS MINUS buttons Connection for handpiece Pump cover OPEN Pump cover Stand holder Display ...

Page 20: ...20 Description of rear panel Power socket Fuse holder with 2 fuses REF 06661800 250 V T1 25AH Power switch I O ON OFF Stand holder Connecting socket for foot control ...

Page 21: ...21 Description Foot control S N1 S NW ORANGE Change program Handle attach detach GREEN Pump ON OFF GREY Start motor pedal VARIABLE or ON OFF Factory setting variable YELLOW Activate boost function ...

Page 22: ...rol units Keep the ORANGE button pressed to switch between the control units Pump ON OFF Only when the motor is stationary can the pump be switched on or off by operating the GREEN button When the pump is switched off the pump symbol on the display is crossed out Press the GREEN button to increase the quantity of coolant in stages Keep the GREEN button depressed to decrease the quantity of coolant...

Page 23: ... for intracardiac application Temperature information Temperature of the medical device on the operator side maximum 55 C 131 F Temperature of the medical device on the patient side front area of the handpiece maximum 48 C 118 4 F Temperature of the medical device on the patient side LED socket maximum 48 C 118 4 F Temperature of the working part instrument maximum 41 C 105 8 F Coolant tube ...

Page 24: ...he handpiece cable Pay attention to the positioning Place the control unit on a flat level surface Ensure that the control unit can be disconnected from the power supply at any time Insert the stand Pay attention to the positioning Maximum load capacity 1 5 kg Attach the universal support and lock it ...

Page 25: ...ver Connect the spray tube to the handpiece Connect the control unit to the power supply Disconnect the control unit from the power supply Switch the control unit on or off at the power switch Once it has been switched on the coolant filling function will appear on the display and the PLUS MINUS buttons will flash c d e a b b b a a c d e b Switching on and off a ...

Page 26: ... MINUS buttons at the same time to activate the coolant filling function Press any button on the device to stop the coolant filling function The coolant filling function will only appear on the display if a handpiece is connected The coolant filling function can be started at any time by pressing the PLUS MINUS buttons Coolant filling function ...

Page 27: ...s into place Carefully pull off the instrument changer Verify full engagement Removing an instrument Attach the instrument changer to the instrument Twist off the instrument with the instrument changer Keep the instrument in the stand until a hygiene and maintenance process is carried out 8 Instruments Insert remove ...

Page 28: ...ct settings Calling up the setup settings Press the and buttons at the same time to access the setup options Press the or button to select the setup setting The selected Setup setting is framed green Foot control Volume Variable or ON OFF Operating hours counter Volume display Instrument detection Activate deactivate Reset Return 9 Setup settings Control unit ...

Page 29: ...settings Foot control S N1 Select setting VARIABLE factory setting Stepless power regulation of the instrument up to the power set in the respective program ON OFF To change from VARIABLE to ON OFF Foot control ...

Page 30: ...30 Setup settings Volume Volume Increase volume Decrease volume Mute ...

Page 31: ...31 Setup settings Reset factory settings Reset Start reset countdown The reset countdown can be interrupted within 5 seconds The control unit will restart after the factory settings have been reset ...

Page 32: ...utton to select the required menu The selected menu is framed green Press the and button simultaneously to switch from the main menu settings into the setup menu settings Instrument display Programs 1 3 Power Coolant Operating mode Boost function Main menu settings ...

Page 33: ...33 Program Next program Previous program Operation Changing the program P1 P3 ...

Page 34: ...wer The power range can be set from 5 100 Each change is immediately saved in the selected program By keeping the PLUS MINUS button pressed you can continuously increase decrease the power The instrument s maximum power setting is shown on the instrument card ...

Page 35: ... coolant quantity during use Coolant Increase flow rate in 10 steps Decrease flow rate in 10 steps By keeping the PLUS MINUS button pressed you can continuously increase decrease the coolant flow rate Coolant OFF The max operating time without coolant is 15 seconds Press the PLUS MINUS buttons at the same time to activate the coolant filling function at any time ...

Page 36: ...rating mode during application Changing the operating mode Basic The handpiece power remains the same irrespective of the load on the instrument Smooth In the Smooth mode the power is reduced with increasing pressure on the instrument Power In the Power mode the power is increased with increasing pressure on the instrument ...

Page 37: ...performance by 20 of the set value for 15 seconds Activate the boost function by pressing the yellow button on the foot control Group 1 Group 2 Group 3 Program P1 P2 P3 P1 P2 P3 P1 P2 P3 Power 20 30 40 45 55 65 70 80 90 Coolant 50 50 50 50 50 50 60 60 60 Operating mode Boost function ...

Page 38: ...Info Foot control recognized Handpiece not recognized Connect handpiece Check LED socket correctly attached defective Check handpiece coupling Check supply hose Handpiece error Handpiece must be dry Check handpiece coupling Check supply hose Check instrument Info Handpiece recognized Instrument not recognized Insert the instrument Check instrument only use W H approved instruments Info Instrument ...

Page 39: ...fective Activate emergency mode see pages 40 41 or change the LED socket Button keypad pressed during power on Switch off the device and restart Error electronics temperature Switch off device and allow to cool down Observe permissible ambient temperature Observe operating mode Scaler timeout Check foot control must not be active for longer than 15 minutes without interruption System error Switch ...

Page 40: ... the same time to access the setup settings Press the PLUS MINUS button to deactivate instrument tip detection Instrument tip detection deactivated Press the PLUS MINUS buttons at the same time to activate the coolant filling function To exit the setup settings select Return using the shift button Confirm with the PLUS button ...

Page 41: ... 70 The coolant quantity can be set between 10 and 100 The coolant quantity cannot be deactivated in emergency mode Power Coolant In emergency mode it is not possible to switch between programs change the mode or activate the boost function Instrument display ...

Page 42: ... only detergents which are intended 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 Österreichisch...

Page 43: ...amaged 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 handpiece with cable after 500 processing cycles or one year We recommend to replace the instrument changer after 1000 processing cycles We recommend checking the instruments for material wear after 60 reprocessing cycles Limitations ...

Page 44: ...ds Ensure that all coolant outlets are rinsed out Remove the instrument Remove the handpiece with cable Wipe the entire surface of the handpiece with cable 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 disinfecting step after cleaning Hygiene and maintenance Initial treatment at the ...

Page 45: ... 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 control unit in water or clean it under running water Instruments Clean and disinfect diamond coated instruments in an ultrasonic bath Evidence of the basic suitability of the instruments for effective manual cleaning and disinfection was provided by an ind...

Page 46: ... of the coolant tubes spray nozzles Clean and disinfect the nozzle cleaner in an ultrasonic bath a washer disinfector Clean outlets carefully with the nozzle cleaner to remove dirt and deposits Blow through the coolant tube and coolant outlets using compressed air In case of blocked coolant outlets or coolant tubes contact an authorized W H service partner ...

Page 47: ...Wash the light source with cleaning fluid and a soft cloth Blow the light source dry using compressed air or dry it carefully with a soft cloth Carry out a visual inspection after each cleaning process Do not use the medical device if the light source is damaged and contact an authorized W H service partner ...

Page 48: ...e basic suitability of the handpiece with cable the universal support the stand the instruments and the instrument changer for effective manual disinfection was provided by an independent test laboratory using the mikrozid AF wipes disinfectant Schülke Mayr GmbH Norderstedt and CaviWipes Metrex Hygiene and maintenance Manual disinfection ...

Page 49: ...nd disinfection internal and external Screw the W H adaptor into the adaptor on the injector rail Screw the instrument onto the W H adaptor Evidence of the basic suitability of the handpiece with cable the universal support the stand the instruments and the instrument changer for effective automated disinfection was provided by an independent test laboratory using the Miele PG 8582 CD washer disin...

Page 50: ...d Instruments Instrument changer Ensure that the handpiece with cable the universal support the stand the instruments and the instrument changer are completely dry internally and externally after cleaning and disinfection Remove liquid residues using compressed air Drying ...

Page 51: ...trument changer after cleaning and disinfection for damage visible residual soiling and surface changes Reprocess the handpiece with cable the universal support the stand the instruments and the instrument changer that are still soiled Sterilize the handpiece with cable the universal support the instruments and the instrument changer following cleaning and disinfection Inspection maintenance and t...

Page 52: ...the instrument changer in sterilization packages that meet the following requirements The sterilization package 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 filled sterilization package must not be under tension Packaging ...

Page 53: ...s provided by the manufacturers of steam sterilizers The program selected must be suitable for the handpiece with cable the universal support the instruments and the instrument changer 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 Maximum sterilization tem...

Page 54: ...steam sterilizer W H Sterilization S r l Brusaporto BG and the Systec VE 150 steam sterilizer Systec 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 Drying times Dynamic air removal prevacuum cycle type B 132 C 270 F 30 minutes Steam flush pressure pulse cycle type S 132 C 270...

Page 55: ...h cable Universal support Instruments Instrument changer 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 56: ...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 ...

Page 57: ... 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 Do not coil the cable around the handpiece and do not twist or kink the handpiece cable Risk of damage ...

Page 58: ...tners Link https www wh com 07945930 Transportation case 04653500 Handle for foot control 07172900 Sterilization cassette 06985000 Handpiece with 1 8 m cable incl 5 clips 07159200 Handpiece with 3 5 m cable incl 10 clips 07004400 Foot control S N1 30264001 Foot control S NW 08046870 Clips 5 pcs 06205600 LED socket 06661800 Fuse T1 25AH ...

Page 59: ... cleaner 07721800 Universal support 04363600 Irrigation tubing set 2 2 m 3 pcs disposable item 04364100 Irrigation tubing set 3 8 m 3 pcs disposable item 04005900 Stand 04719400 Irrigation tubing set 2 2 m 2 07233500 W H Adapter kit 07795800 SPI dongle ...

Page 60: ...umidity during operation 15 to 80 relative non condensing Control unit SA 320 Supply voltage 100 130 V 220 240 V Frequency 50 60 Hz Permitted voltage fluctuation 10 Nominal current 0 1 1 0 A 0 1 0 5 A Mains fuse 2 x 250 V T1 25AH Max power consumption 90 VA Max output power 24 W Operating frequency 22 35 kHz Coolant flow rate at 100 at least 50 ml min Operating mode S3 1min 6min Dimensions in mm W...

Page 61: ...or functional earth connection only Type B applied part not suitable for intracardiac application Classification according to Paragraph 6 of the General Specifications for the Safety of Medical Electrical Devices according to IEC 60601 1 ANSI AAMI ES 60601 1 S N1 S NW are waterproof according to IPX8 1 m depth of immersion 1 hour water tight in accordance with IEC 60529 ...

Page 62: ... 18 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 ...

Page 63: ......

Page 64: ...giene 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 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 inst...

Page 65: ...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 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 ins...

Page 66: ......

Page 67: ...defects within a warranty period of 12 months from the date of purchase Accessories and consumables instruments sterilization cassette irrigation tubing set clips nozzle cleaner O rings fuses and adaptor set are excluded from 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 warran...

Page 68: ...68 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 69: ...hted by W H Dentalwerk Bürmooos GmbH or third parties The source code of the used software components Linux Qt U Boot and CanFestival will be provided on request charging all arising expenses Please contact opensource wh com There is no warranty transferring this software neither implied warranty nor express warranty You will find further information concerning the applied license versions and the...

Page 70: ... 8 kV contact 15 kV air Floor should be wood concrete or ceramic tile If floors are covered with synthetic material the relative humidity should be at least 30 Electrical fast transient bursts IEC 61000 4 4 2 kV for power supply lines 1 kV for input output lines 5kHz repetition rate 2 kV for power supply lines 1 kV for input output lines 100kHz repetition rate 2 kV for power supply lines 1 kV for ...

Page 71: ...ch frequency range Interference may occur in the vicinity of equipment marked with the symbol described lateral Note 1 At 80 MHz and 800MHz the higher frequency range applies Note 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects people and animals The ISM industrial scientific and medical bands between 0...

Page 72: ...00 CDMA 1900 GSM 1900 DECT LTE Band 1 3 4 25 UMTS Pulse modulation b 217 Hz 2 0 3 28 1845 1970 2450 2400 2570 Bluetooth WLAN 802 11 b g n RFID 2450 LTE Band 7 Pulse modulation b 217 Hz 2 0 3 28 5240 5100 5800 WLAN 802 11 a n Pulse modulation b 217 Hz 0 2 0 3 9 5500 5785 NOTE If necessary to achieve the IMMUNITY TEST LEVEL the distance between the transmitting antenna and the product may be reduced...

Page 73: ...tput power rating of the transmitter in watts W according to the transmitter manufacturer Note 1 At 80 MHz and 800MHz the higher frequency range applies Note 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects people and animals Electromagnetic Emission Table 1 IEC 60601 1 2 2007 The product is suitable for...

Page 74: ...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 50756 AEN Rev 022 19 02 2021 Subject to alterations ...

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