W&H Proxeo Ultra PB-510, Instructions For Use Manual

Page 1: ...Instructions for Use PB 510 PB 520 PB 530...

Page 2: ...8 Control unit PB 510 18 Control unit PB 520 19 Control unit PB 530 20 Foot control C NF C NW 21 Status LED foot control C NW 22 7 Start up 23 Control unit general 23 Control unit PB 530 25 Functions...

Page 3: ...Replacing the coolant filter of the coolant hose 36 Replacing the pump cartridge 37 12 Servicing 38 13 W H accessories and spare parts 40 14 Technical data 42 15 Disposal 45 Explanation of warranty t...

Page 4: ...4 Symbols WARNING risk of injury ATTENTION to prevent damage occurring General explanations without risk to persons or objects in the Instructions for Use...

Page 5: ...RDANCE 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 on the medical devi...

Page 6: ...irect current Do not dispose of with domestic waste Protection against dripping water IPX1 Catalogue number Serial number Date of manufacture DataMatrix Code for product information including UDI Uniq...

Page 7: ...with care Keep dry Temperature limitation Humidity limitation Der Gr ne Punkt The Green Dot trademark of Duales System Deutschland GmbH Trademark of RESY OfW GmbH for identification of recyclable tra...

Page 8: ...iezoceramic oscillating system which moves the tip in a linear oscillation The drive unit is used for the removal of supragingival calculus and subgingival concretions and for endodontic application a...

Page 9: ...ant filter pump cartridge Modifications or repairs must only be undertaken by an authorised W H service partner see page 47 The medical device has no components that can be repaired by the user The el...

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 performa...

Page 11: ...unit the coolant tank and the foot control Remove the Instructions for Use and the accessories W H packaging is environmentally friendly and can be disposed of by industrial recycling companies Howeve...

Page 12: ...REF 05075600 Coolant hose 6 mm approx 2 m X REF 08016690 Power supply with adaptor X X X REF 07991190 Coolant tank X X REF 08014700 Cable pairing charging X Optional REF 30316000 Foot control C NW RE...

Page 13: ...ase of coolant supply failure the medical device must be stopped immediately The exception to this is in endodontic applications where coolant is not used Maximum operating time without coolant 2 minu...

Page 14: ...on in potentially explosive explosive atmospheres Disconnect the medical device in dangerous situations from the power supply Pull the power supply out of the socket Only use the cable supplied for th...

Page 15: ...PB 530 Never fill or top up the coolant tank with liquids hotter than 30 C 86 F Replace a faulty or leaky pump cartridge immediately Control unit PB 510 PB 520 PB 530 Risks due to electromagnetic fiel...

Page 16: ...ical impacts Battery C NW Do not charge the battery unattended As soon as the charging cycles start to deteriorate send the medical device to an authorized W H service partner Defective or worn out ba...

Page 17: ...in EN 50527 2 1 2016 for unipolar and bipolar pacemakers and is therefore suitable for patients with pacemakers Find out if patient and user have implanted systems before using the medical device and...

Page 18: ...ion Control unit PB 510 Power range Connections Power supply ESI external service interface Foot control Coolant hose Status LED Power regulator Cover OFF Handpiece support adjustable Supply hose Cool...

Page 19: ...nit PB 520 Power range Coolant tank Status LED Power regulator Filling level indicator Coolant regulator OFF Connections Power supply ESI external service interface Foot control Cover Handpiece suppor...

Page 20: ...insing function Cleaning function Pairing Power regulator Coolant tank Connections Power supply ESI external service interface Cable pairing charging OFF Filling level indicator Function button Rinsin...

Page 21: ...21 Description Foot control C NF C NW Charging LED orange Status LED green Connection for cable pairing charging Cable pairing charging C NW C NF...

Page 22: ...steady steady flashes flashesintermittently GREEN e e Connection to paired medical device established e e Foot control is attempting to establish a connection to the paired medical device e e Battery...

Page 23: ...rew the cap nut from the coolant filter Attach the coolant hose through the cap nut onto the coolant filter Screw the cap nut tight Push the coolant hose until the limit stop Control unit PB 510 Remov...

Page 24: ...nk and attach it The coolant tank snaps audibly into place Plug the power supply into a socket Pull the power supply out of the socket Control unit PB 510 PB 520 PB 530 Slide the adapter onto the powe...

Page 25: ...ith control unit PB 530 Coolant and handpiece inactive The foot control C NW and control unit PB 530 are not paired when delivered Pairing foot control C NW with control unit PB 530 Set power regulato...

Page 26: ...foot control battery status visible for 5 seconds Press function button battery status visible for 5 seconds Disconnect charging cable battery status visible for 5 seconds Set power Power set The batt...

Page 27: ...tery of foot control is flat e e Power setting 1 LED flashes green remaining LEDs are flashing green Charge the battery e e Power setting 0 1 LED flashes white blue Charge the battery Control unit and...

Page 28: ...ming the cleaning function once a month using the active substance chlorhexidine 0 2 Fill coolant tank with at least 200 ml cleaning liquid Then perform a rinsing function with tap water Approved cool...

Page 29: ...ng function with one of these options Press foot control Adjust power regulator Control unit PB 530 Remove the handpiece from the supply Adjust power Press funtion button 1 second Rinsing function act...

Page 30: ...tion button 3 seconds Cleaning function active for 8 minutes visible by blue LEDs Pump stops several times during the cleaning function Cleaning function finished after all blue LEDs go out Cancelling...

Page 31: ...safety notes in the Instructions for Use of the W H handpieces Set power and coolant variable Press foot control Release foot control Fade out time of the handpiece LED 30 seconds Control unit PB 530...

Page 32: ...piece to the supply hose Insert the tip Put the medical device into operation In the event of operating malfunctions e g vibrations unusual noise overheating coolant failure or leakage stop the medica...

Page 33: ...ible ambient temperature operating mode 2x Foot control Release foot control 5x Time out 15 min Release foot control must not be active for longer than 15 minutes without interruption 6x Handpiece Che...

Page 34: ...se foot control must not be active for longer than 15 minutes without interruption 6 LED orange Handpiece Check tip full engagement damage torque Dry the handpiece supply hose Check plug in connection...

Page 35: ...ectives standards and guidelines for cleaning disinfection and sterilization Wear protective clothing safety glasses face mask and gloves Wipe the entire medical device and the foot control with disin...

Page 36: ...g of the coolant tank Remove the O ring with tweezers Slide on the new O ring Replacing the coolant filter of the coolant hose Replace the coolant filter if it is soiled or after 1 year at the latest...

Page 37: ...e pump cartridge Uncrew cover and remove Attach the coolant hoses until the limit stop Unlock pump cartridge and pull it out Pull off coolant hoses Attach new pump cartridge Snaps audibly into place A...

Page 38: ...include the following procedures Control unit External visual inspection Measurement of the device leakage current Measurement of patient leakage current Visual inspection of internal components on su...

Page 39: ...In the event of operating malfunctions immediately contact an authorized W H service partner Repairs and maintenance work must only be undertaken by an authorized W H service partner Always return equ...

Page 40: ...rts or accessories approved by W H Suppliers W H partners 30326000 Handpiece PB 5 L 30327000 Handpiece PB 5 L Q 30328000 Handpiece PB 5 L S 02675000 Coolant filter 05075600 Coolant hose 07991190 Coola...

Page 41: ...41 W H accessories and spare parts 30316000 Foot control C NW with Stick 04717300 Foot control C NF...

Page 42: ...6sec Max oscillation amplitude Tip 1U 0 2 mm Max water pressure 1 6 bar Max coolant flow adjustable ca 50 ml min Dimensions in mm WxDxH 120 x 185 x 110 120 x 185 x 205 120 x 185 x 205 Weight 807 g 1 0...

Page 43: ...tage 3 7 V Nominal capacity 680 mAh Dimensions WxDxH 117 x 117 x 38 mm Weight 190 g Ambient conditions Temperature during storage and transport 20 C to 60 C 4 F to 140 F Humidity during storage and tr...

Page 44: ...Pollution level 2 Overvoltage category II Altitude up to 3 000 m above sea level Charger Class II medical electrical equipment Classification according to Paragraph 6 of the General Specifications fo...

Page 45: ...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 46: ...material or manufacturing defects within a warranty period of 24 months from the date of purchase Accessories and consumables pump cartridge coolant hose coolant filter O rings are excluded from the...

Page 47: ...nited Kingdom t 44 1727 874990 f 44 1727 872254 E Mail technical uk wh W H Impex Inc 6490 Hawthorne Drive Windsor Ontario N8T 1J9 Canada t 1 800 2656277 1 519 9446739 f 1 519 9746121 E Mail service ca...

Page 48: ...erial 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 line...

Page 49: ...h 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 ma...

Page 50: ...0 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 51...

Page 51: ...ut 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 situ...

Page 52: ...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 50968 AEN Rev 001 15 04 2019 Subject to alterations...