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Symbols

Do not dispose of with domestic
waste

WARNING!

(risk of injury)

ATTENTION!

(to prevent damage occurring)

General explanations,
without risk to persons or
objects

Follow instructions for use

Manufacturer

Date of manufacture

CE mark
with identification number
of the Notified Body

XXXX

Medical device

Thermo washer disinfectable

Sterilizable
up to the stated temperature

Class II medical
electrical equipment

Not for re-use

Non-ionizing electromagnetic
radiation

Catalogue number

Serial number

DC – direct current

Non-sterilizable

Содержание proxeo TWIST

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

Страница 2: ...Charging the battery 19 Query battery status 20 Pairing 21 Assembly removal of the Prophy Angle 23 6 Handpiece drive 24 Switch on off 24 Test run 25 7 Hygiene and maintenance 26 General notes 26 Limit...

Страница 3: ...cing 38 10 Accessories consumables spare parts and other recommended medical devices by W H 40 11 Technical data 41 12 Data on electromagnetic compatibility according to IEC EN 60601 1 2 44 13 Disposa...

Страница 4: ...ollow instructions for use Manufacturer Date of manufacture CE mark with identification number of the Notified Body XXXX Medical device Thermo washer disinfectable Sterilizable up to the stated temper...

Страница 5: ...order of a physician dentist veterinarian or with the descriptive designation of any other practitioner licensed by the law of the State in which the practitioner practices to use or order the use of...

Страница 6: ...6 Symbols l RCM Australian New Zealand GITEKI MIC Japan ANATEL Brazil FCC IC USA Canada R 209 J00204...

Страница 7: ...t importance to us Observe the safety 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 Mis...

Страница 8: ...irs must only be undertaken by an authorized W H service partner see page 49 The electrical installation at the premises must comply with the regulations laid out in IEC 60364 7 710 Installation of el...

Страница 9: ...9 2 Scope of delivery REF Description 30317000 Handpiece drive 07969610 Charger with adaptor 05882600 Handpiece holder Optional included in set 30316000 Foot control C NW with Stick...

Страница 10: ...contacts on the medical device simultaneously Only put the medical device into operation when the handpiece sleeve is attached Do not expose the medical device to any violent mechanical impacts Batter...

Страница 11: ...evice is not approved for operation in potentially explosive atmospheres Charger Only use chargers approved by W H Hygiene and maintenance prior to initial use Clean and disinfect the medical device S...

Страница 12: ...cardiac pacemaker of at least 15 cm 5 9 inch is maintained The functionality of other active implantable medical devices AIMD e g ICD can be affected by electric magnetic and electromagnetic fields F...

Страница 13: ...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 within the patient environmen...

Страница 14: ...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...

Страница 15: ...15 4 Description Handpiece drive ON OFF button Handpiece sleeve Charging socket Coupling for Prophy Angle Nose Status LED handpiece drive see page 17 Status LED foot control see page 18...

Страница 16: ...16 Description Foot control C NW Charging LED orange see page 18 19 Status LED green see page 18 21 Reset button Pairing button Charging socket Stick...

Страница 17: ...ORANGE e Battery is charging Not ready for operation e Battery is 2 25 charged Complete the treatment Do not start any further treatment Charge the battery e Battery is 1 charged Charge the battery R...

Страница 18: ...ooting with pairing problems see page 22 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...

Страница 19: ...rst time Insert the charging cable into the handpiece drive charging socket until it audibly engages Plug the charger into an power socket Connect the charging cable into the foot control charging soc...

Страница 20: ...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...

Страница 21: ...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...

Страница 22: ...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...

Страница 23: ...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...

Страница 24: ...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...

Страница 25: ...level Attach 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 stop the medical...

Страница 26: ...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...

Страница 27: ...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...

Страница 28: ...ire handpiece drive the handpiece sleeve and the handpiece holder with disinfectant Ensure that no fluids enter the medical device Switch the handpiece drive off The charger must not be connected Note...

Страница 29: ...the handpiece drive s basic suitability for effective manual cleaning was provided by an independent test laboratory using tap water 35 C and towels cloth WIPEX WET DESI premium NORDVLIES GmbH Bargteh...

Страница 30: ...the handpiece drive the handpiece sleeve and the handpiece holder for effective manual disinfection was provided by an independent test laboratory using the mikrozid AF wipes disinfectant Sch lke Mayr...

Страница 31: ...handpiece holder are not approved for automated processing in a washer disinfector and sterilization Evidence of the handpiece sleeve s basic suitability for effective automated disinfection was prov...

Страница 32: ...32 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...

Страница 33: ...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...

Страница 34: ...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...

Страница 35: ...s Maximum sterilization temperature 135 C 275 F Evidence of the handpiece sleeve s basic suitability for effective sterilization was provided by an independent test laboratory using the LISA 517 B17L...

Страница 36: ...36 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...

Страница 37: ...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...

Страница 38: ...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...

Страница 39: ...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...

Страница 40: ...882600 Handpiece holder 07918800 Handpiece sleeve 07969610 Charger incl adaptor 30316000 Foot control C NW with Stick 02695700 O ring 3 pcs 07979710 Prophy Angle Cup 105 firm dark green 100 pcs 079949...

Страница 41: ...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...

Страница 42: ...ger Rated voltage 100 240 V Permissible voltage fluctuation 10 Frequency 50 60 Hz Power 7 VA Freuquency band 2 4 GHz ISM band 2 402 2 480 GHz Transmitting power 3 dBm Modulation GFSK Channels 40 chann...

Страница 43: ...t 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 ANSI AAMI ES 6...

Страница 44: ...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 45: ...ts 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 t...

Страница 46: ...3 80 MHz 2 7 GHz 10 V m Proximity fields from RF wireless communications equipment IEC EN 61000 4 3 710 745 780 5240 5500 5785 MHz 9 V m 385 MHz 27 V m 450 810 870 930 1720 1845 1970 2450 MHz 28 V m...

Страница 47: ...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...

Страница 48: ...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...

Страница 49: ...49 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 50: ...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 009 17 07 2023 Subject to alterations...

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