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2. Safety notes – Handpiece with mini LED+ and generator

> Avoid contact between LED and soft tissue (risk of burning due to the LED heating up).

> Do not use the handpiece as light sensor.

> Do not look directly into the LED.

Danger zones M and G

In accordance with IEC 60601-1 / ANSI/AAMI ES 60601-1, the handpiece is not suitable for use in potentially

explosive atmospheres or with potentially explosive mixtures of anaesthetic substances containing oxygen

or nitrous oxide.

The handpiece is not suitable for use in oxygen enriched atmospheres.

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Содержание S-11 L G

Страница 1: ...Instructions for use Surgical Handpieces with mini LED and generator S 9 L G S 11 L G Handpieces without light S 9 S 10 S 11 S 12 S 15...

Страница 2: ...oduction 6 8 2 Safety notes 9 13 General 9 10 Handpiece with mini LED and generator 11 13 3 Product description 14 15 Straight handpiece S 11 L G S 11 S 15 14 Angled handpiece S 9 L G S 9 S 10 S 12 15...

Страница 3: ...31 Manual disinfection 32 Mechanical cleaning disinfection lubrication 33 34 Reassemble 35 38 Oil service 39 40 Sterilization and storage 41 42 6 W H Accessories and spare parts 43 7 Technical data 4...

Страница 4: ...l explanations without risk to persons or objects Do not dispose of with domestic waste Caution Federal law restricts this device to sale by or on the order of a dentist physician or any other practit...

Страница 5: ...to the stated temperature Date of manufacture CE 0297 from the manufacturer Symbols on the handpiece packaging Data Matrix Code for product identification e g in hygiene maintenance process UL Compon...

Страница 6: ...ations quality norms and industry standards For your safety and the safety of your patients Prior to initial use please read the Instructions for use These explain how to use your W H product and guar...

Страница 7: ...duct according to the EU Directive 93 42 EEC Responsibility of the manufacturer The manufacturer can only accept responsibility for the safety reliability and performance of the handpiece when it is u...

Страница 8: ...ntained by staff who have been trained in procedures for infection control personal safety and patient safety Improper use e g through poor hygiene and maintenance non compliance with our instructions...

Страница 9: ...dpiece must be stopped immediately Check the handpiece for damage and loose parts each time before using Do not operate the handpiece if it is damaged Only attach the handpiece onto the motor when the...

Страница 10: ...rior to initial use The handpiece is in a clean condition and sealed in PE film when delivered Lubricate the handpiece Sterilize the handpiece the nozzle cleaner and the coolant tube Oil service page...

Страница 11: ...s light sensor Do not look directly into the LED Danger zones M and G In accordance with IEC 60601 1 ANSI AAMI ES 60601 1 the handpiece is not suitable for use in potentially explosive atmospheres or...

Страница 12: ...ibacterial soaps such atmospheres are typically localized and temporary Zone M comprises a truncated pyramid below the operating table which is tilted outwards at a 30 angle Zone G also known as an en...

Страница 13: ...netic fields Find out if patient and user have implanted systems before using the product and consider the application Weigh the risks and benefits Keep the product away from implanted systems Make ap...

Страница 14: ...raight handpiece S 11 L G S 11 S 15 LED only S 11 L G Handpiece head Coolant tube movable Chuck lever Area of chuck lever Shaft Sheath Long nozzle cleaner Symbols on the parts and Sheath open Directio...

Страница 15: ...L G S 9 S 10 S 12 LED only S 9 L G Handpiece head Coolant tube movable Chuck lever Area of chuck lever Shaft Knee Lower shaft Sheath Long nozzle cleaner Symbols on the parts and Sheath open Direction...

Страница 16: ...16 4 Operation Assembly Removal Coolant tube Fit the coolant tube or Pull off the coolant tube...

Страница 17: ...n Push the handpiece onto the motor Check the secure hold on the motor or Remove the handpiece from the motor by pulling in an axial direction or by pressing the release button When using a locking pi...

Страница 18: ...ry instrument Follow the operating instructions of the manufacturer Insert the rotary instrument only when the handpiece is stationary Never touch the rotary instrument which is still rotating Do not...

Страница 19: ...until back stop When using a locking pin Insert the rotary instrument until back stop and turn until the locking pin engages Return the chuck lever to the initial position Check secure location by ap...

Страница 20: ...rotary instrument Start the handpiece In the event of operating malfunctions e g vibrations unusual noise overheating coolant failure or leakage or discoloration of the LED stop the handpiece immediat...

Страница 21: ...ocess the handpiece manually or mechanically Wear protective clothing Remove the handpiece from the motor Remove the rotary instrument Clean and disinfect the handpiece immediately after every treatme...

Страница 22: ...g to EN 13060 For Canada Hospital grade sterilization with pre and post vacuum cycle Reassemble the handpiece following manual cleaning and disinfection Without coolant tube Types and serial numbers m...

Страница 23: ...23 Pre disinfection If heavily soiled Clean first with disinfectant cloths Only use disinfectants that have no protein fixing effects...

Страница 24: ...24 Disassemble straight handpiece S 11 L G S 11 S 15 Pull off the coolant tube Turn off the sheath from the handpiece head by turning once Unlock and swivel the chuck lever...

Страница 25: ...25 Remove the chuck lever Remove the shaft from the handpiece head...

Страница 26: ...26 Disassemble angled handpiece S 9 L G S 9 S 10 S 12 Pull off the coolant tube Press sheath firmly against knee Turn off the sheath from the handpiece head by turning once...

Страница 27: ...the lower shaft from the knee Turn off the knee from the handpiece head Unlock and swivel the chuck lever Pull off the shaft until back stop and remove the chuck lever Remove the shaft from the handp...

Страница 28: ...ernal and external Rinse and brush off under demineralized water 38 C 100 F Remove any liquid residues absorbent cloth blow dry with compressed air Do not place the handpiece in liquid disinfectant or...

Страница 29: ...ice partner see page 51 Clean coolant outlets carefully with the nozzle cleaner to remove dirt and deposits Blow through the coolant tube with the air syringe The removable coolant tube and the nozzle...

Страница 30: ...30 S 9 L G S 11 L G Cleaning of the LED Avoid scratching of the LED Wash the LED with cleaning fluid and a soft cloth...

Страница 31: ...al inspection after each cleaning process Do not use the handpiece if the LED is damaged and contact an authorized W H service partner see page 51 Blow the LED dry with air syringe or dry it carefully...

Страница 32: ...do not contain chlorine and which are certified by officially recognized institutes For Canada Use EPA registered surface disinfectants Note the manufacturer s specifications for the use of the disinf...

Страница 33: ...mends mechanical cleaning and lubrication with W H Assistina Follow the instructions in the Assistina Instructions for use S 10 S 12 only with W H Assistina 301 Mechanical cleaning and disinfection in...

Страница 34: ...tor into the adaptor on the injector rail Screw the W H intermediate adaptor onto the W H adaptor Put the W H silicone hose over the W H intermediate adaptor Insert the external coolant tube into the...

Страница 35: ...of the area of chuck lever Insert the shaft into the handpiece head Insert chuck lever a and turn it to initial position b Only S 11 L G Position the golden contacts on the shaft and handpiece head s...

Страница 36: ...36 Check free running of the shaft Insert the sheath onto the handpiece head Note the symbols and turn until locked...

Страница 37: ...g of the area of chuck lever Insert the shaft into the handpiece head Insert chuck lever a and turn it to initial position b Only S 9 L G Position the golden contacts on the shaft and handpiece head s...

Страница 38: ...the knee onto the handpiece head Note the symbols and turn until locked Insert lower shaft into the knee Check free running of the lower shaft Insert sheath onto the knee Note the symbols and turn unt...

Страница 39: ...every internal cleaning Before each sterilization With W H Service Oil F1 MD 400 Follow the instructions on the oil spray can and on the packaging or With W H Assistina Follow the instructions in the...

Страница 40: ...ownwards Start the handpiece for 30 seconds to remove excessive oil Start at the minimum speed and increase to the maximum speed within 5 to 10 seconds Repeat the complete hygiene and maintenance proc...

Страница 41: ...handpiece before sterilizing Wrap the handpiece and the accessory in sterile goods packing according to EN 868 5 For Canada Place the handpiece and the accessory in a standard handpiece sterilization...

Страница 42: ...si up to 2 16 bar 31 3 psi or Steam sterilization class S with sterilizers in accordance with EN 13060 The sterilizer manufacturer must give its express approval for the sterilization of handpieces St...

Страница 43: ...sistina 301 19922000 Assistina 3x2 MB 200 19923000 Assistina 3x3 MB 300 10940021 Service Oil F1 MD 400 6 pcs 02038200 Spray cap with nozzle 00636901 Long nozzle cleaner 06879500 Coolant tube for S 9 S...

Страница 44: ...ht handpiece S 11 L G S 11 S 15 Transmission ratio 1 1 1 1 1 1 Colour coding blue blue blue Motor connection according to standard ISO 3964 ISO 3964 ISO 3964 Rotary instruments ISO 1797 1 mm Permitted...

Страница 45: ...piece S 9 L G S 9 S 10 S 12 Transmission ratio 1 1 1 1 1 2 Colour coding blue blue orange Motor connection according to standard ISO 3964 ISO 3964 ISO 3964 Rotary instruments ISO 1797 1 mm Permitted b...

Страница 46: ...F Temperature of the working part rotary instrument maximum 41 C 105 8 F Physical characteristics Temperature for storage and transport 40 C to 70 C 40 F to 158 F Air humidity for storage and transpo...

Страница 47: ...t The handpiece along with its packaging has been designed to be as environmentally friendly as possible Disposal of the handpiece Follow your local and national laws directives standards and guidelin...

Страница 48: ...atible and disposal aspects and can be recycled Please send old packaging materials to the relevant collection and reprocessing system This way you will contribute to the recycling of raw materials an...

Страница 49: ...manufacturer W H is liable for material or manufacturing defects within a warranty period of 12 months from the date of purchase We accept no responsibility for damage caused by incorrect handling or...

Страница 50: ......

Страница 51: ...fordshire 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 1 519 9446739 f 1 519 9746121 E Mail service ca wh com W H Au...

Страница 52: ...Manufacturer Form Nr 50754 AEN Rev 006 07 03 2019 Subject to alterations 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...

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