W&H proxeo TWIST PL-40 H Instructions For Use Manual Download | Manualshive

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Hygiene and maintenance

> Check the medical device after cleaning and disinfection for damage, visible residual soiling and surface changes.

> Reprocess any medical devices that are still soiled.

> Sterilize the handpiece sleeve following cleaning and disinfection.

Inspection, Maintenance and Testing

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Summary of Contents for proxeo TWIST PL-40 H

Page 1: ...Instructions for use PL 40 H...

Page 2: ...ontrol 20 6 Start up 21 Charging the battery 21 Query battery status 22 Pairing 23 Assembly removal of the Prophy Angle 25 7 Handpiece drive 26 Switch on off 26 Test run 27 8 Hygiene and maintenance 2...

Page 3: ...ng 36 Sterilization 37 Storage 38 9 Replacing the O ring 39 10 Servicing 40 11 W H Accessories and spare parts 42 12 Technical data 43 13 Disposal 46 Explanation of warranty terms 47 Authorized W H se...

Page 4: ...4 Symbols WARNING risk of injury ATTENTION to prevent damage occurring General explanations without risk to persons or objects Not for re use 2 Call customer service in the instructions for use...

Page 5: ...e Do not dispose of with domestic waste Thermo washer disinfectable Date of manufacture The medical device with reference to electrical safety mechanical safety and fire prevention conforms to UL 6060...

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

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: ...afety notes Intended use PL 40 H Battery driven electrical drive unit with wireless foot controller to perform cleaning and polishing of tooth surfaces and fillings C NW Foot control for operation of...

Page 9: ...aced O ring Modifications or repairs must only be undertaken by an authorized W H service partner see page 48 The foot control has no components that can be repaired by the user The electrical install...

Page 10: ...to an increased emission of electromagnetic interference or to a reduced resistance against electromagnetic interference You can find the current EMC manufacturer s declaration on our website at http...

Page 11: ...11 3 Scope of delivery REF Description 30317000 Handpiece drive 30316000 Foot control C NW with Stick 07969610 Charger with adaptor 05882600 Handpiece holder...

Page 12: ...nto operation when the handpiece sleeve is attached Keep the foot control away from magnetic fields Replace the foot control as soon as the resistance is noticeably reduced Do not expose the medical d...

Page 13: ...approved for operation in potentially explosive atmospheres Charger Only use the charger supplied Hygiene and maintenance prior to initial use Clean and disinfect the medical device Sterilize the han...

Page 14: ...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 con...

Page 15: ...e Foot control 1 8 3 m 2 5 m 1 83 m 1 83 m The patient environment see diagram encompasses the area up to 2 50 m above the patient and 1 83 m in all horizontal directions The charger must not be used...

Page 16: ...w the operating instructions of the manufacturer Insert the Prophy Angle only when the medical device is stationary Never touch the Prophy Angle while it is still rotating Only use Prophy Angles with...

Page 17: ...17 5 Description Handpiece drive ON OFF button Handpiece sleeve Charging socket Coupling for Prophy Angle Nose Status LED handpiece drive see page 19 Status LED foot control see page 20...

Page 18: ...18 Description Foot control Charging LED orange see page 20 21 Status LED green see page 20 23 Reset button Pairing button Charging socket Stick...

Page 19: ...e e Battery is charging e e Battery is 2 25 charged Complete the treatment Do not start any further treatment Charge the battery e e Battery is 1 charged Charge the battery RED e e Error message Cont...

Page 20: ...ting with pairing problems see page 23 The LED flashes for 40 milliseconds every 4 seconds Standby mode The foot control can be activated by pressing LED steady steady flashes flashes intermittently G...

Page 21: ...e you use them for the first time Connect the charging cable up to the charging socket on the handpiece drive Plug the charger into an power socket Connect the charging cable into the foot control cha...

Page 22: ...tus LED flashes Battery status 3 x green 75 100 2 x green 50 75 1 x green 25 50 orange 2 25 Briefly press the ON OFF button You can query the battery status when the handpiece drive is switched on and...

Page 23: ...ce drive are already paired when delivered If pairing is active Status LED green flashes on the foot control Both devices need to be in pairing mode for it to be possible to pair the handpiece drive a...

Page 24: ...the position of the foot control Eliminate any sources of interference e g brush motors mobile telephones radios WLAN Use the stick to press the reset button on the foot control and try pairing again...

Page 25: ...rophy Angle Cup or Brush Position the groove on the Prophy Angle with the nose of the handpiece drive Push the Prophy Angle onto the handpiece drive until the limit stop Verify full engagement Hold th...

Page 26: ...rol as far as it will go to attain the maximum speed of 3 000 rpm The following light signals are shown on the foot control Foot control pressed Status LED green flashes Foot control is attempting to...

Page 27: ...the Prophy Angle to the handpiece drive Operate the handpiece drive with the foot control In the event of operating malfunctions e g vibrations unusual noise overheating coolant failure or leakage st...

Page 28: ...s 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 e...

Page 29: ...rmined 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...

Page 30: ...oot control with disinfectant Ensure that no fluids enter the medical device Switch the handpiece drive off The charger must not be connected Note that the disinfectant used during pre treatment is on...

Page 31: ...ultrasonic bath Do not immerse the handpiece drive and the foot control in water or clean them under running water Handpiece sleeve Handpiece holder Clean the handpiece sleeve and the handpiece holde...

Page 32: ...e the handpiece sleeve the handpiece holder and the foot control basic suitability for effective manual disinfection was provided by an independent test laboratory using the mikrozid AF wipes disinfec...

Page 33: ...der and the foot control are not approved for automated processing in a washer disinfector and for sterilization Evidence of the medical device s basic suitability for effective automated disinfection...

Page 34: ...34 Hygiene and maintenance Ensure that the medical device is completely dry internally and externally after cleaning and disinfection Remove any liquid residues using compressed air Drying...

Page 35: ...vice after cleaning and disinfection for damage visible residual soiling and surface changes Reprocess any medical devices that are still soiled Sterilize the handpiece sleeve following cleaning and d...

Page 36: ...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 l...

Page 37: ...Sterilization time at least 3 minutes at 134 C 273 F Maximum sterilization temperature 135 C 275 F Evidence of the handpiece sleeve basic suitability for effective sterilization was provided by an in...

Page 38: ...38 Handpiece sleeve 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 39: ...ing Pull the handpiece sleeve off the handpiece drive Squeeze the O ring between your thumb and index finger firmly so that it forms a loop Pull the old O ring off Push the new O ring on in its place...

Page 40: ...intervals are prescribed by law The inspection must be undertaken by a qualified organization and must include the following procedures Handpiece drive External visual inspection Function test Foot c...

Page 41: ...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 proces...

Page 42: ...ved by W H Supplier W H partners 07954780 Handpiece drive 05882600 Handpiece holder 07918800 Handpiece sleeve 07969610 Charger incl adaptor 30316000 Foot control C NW with Stick 02695700 O ring 3 pcs...

Page 43: ...voltage 3 7 V Rated capacity 680 mAh Max speed 3 000 rpm Maximum torque 2 Ncm Dimensions WxDxH 160 x 25 x 28 mm Weight 118 g Ambient conditions Temperature during storage and transport 20 C bis 60 C...

Page 44: ...tage fluctuation 10 Frequency 50 60 Hz Power 7 VA Foot control C NW Battery type Li ion Runtime approx 2 months Standby automatically if not actuated Charging time approx 3 h Rated voltage 3 7 V Rated...

Page 45: ...BF applied part not suitable for intracardiac application Classification according to Paragraph 6 of the General Specifications for the Safety of Medical Electrical Equipment according to IEC 60601 1...

Page 46: ...13 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 47: ...is liable for material or manufacturing defects within a warranty period of 12 months from the date of purchase Accessories and consumables handpiece holder stick are excluded from the warranty We ac...

Page 48: ...ngdom t 44 1727 874990 f 44 1727 872254 E Mail technical uk wh com 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 wh...

Page 49: ......

Page 50: ...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 50928 AEN Rev 004 14 01 2019 Subject to alterations...

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