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10600266 Rev. E

DYONICS™ Handpieces

Instructions for Use

Glossary of Symbols

Caution: U.S. Federal law restricts this device

to sale by or on the order of a physician.

EU: Not for general waste

Humidity

Forward - clockwise direction of rotation

(distal view)

Reverse - counterclockwise direction of

rotation (distal view)

Oscillate - alternating forward/reverse

direction of rotation

Suction On - fluid flow through handpiece

unrestricted

Suction Off - fluid flow through handpiece

blocked

Содержание 7205354

Страница 1: ...DYONICS Handpieces Instructions for Use 10600266 Rev E ...

Страница 2: ......

Страница 3: ...r on the order of a physician EU Not for general waste Humidity Forward clockwise direction of rotation distal view Reverse counterclockwise direction of rotation distal view Oscillate alternating forward reverse direction of rotation Suction On fluid flow through handpiece unrestricted Suction Off fluid flow through handpiece blocked ...

Страница 4: ...indications 5 Warnings 6 Precautions 6 Instructions for Use 8 Suction 8 Hand Control Handpieces 9 Non Hand Control Handpieces 9 Installing a Blade in a Handpiece 11 Installing a Blade in the Mini Motor Drive 11 Blade Window Lock 11 Forward Reverse Speed Shift 11 Cleaning and Sterilizing 12 Cleaning 12 Cleaning Verification 12 Storage 12 Sterilization Parameters 12 Service 13 Handpiece Cable Replac...

Страница 5: ...blades for resection of soft and osseous tissue including but not limited to use in large articular cavities small articular cavities and for Functional Endoscopic Sinus Surgery FESS The FESS application is limited to small blades that are appropriate for the procedure Contraindications Smith Nephew DYONICS Handpieces and Blades should not be used with patients exhibiting ankylosis and also lackin...

Страница 6: ...avoid patient burns do not place the handpiece on the patient when it is not in use Precautions U S Federal law restricts these devices to sale by or on the order of a physician Prior to each use inspect the device to ensure it is functioning properly and not damaged Do not use a damaged device In all cases the judgment of the physician in the best interest of the patient may take precedence over ...

Страница 7: ...cted by one or more of the following measures Reorient or relocate this equipment the other equipment or both Increase the separation between the pieces of equipment Connect the pieces of equipment into different outlets or circuits Consult a biomedical engineer Environmental Protection This equipment contains electronic printed circuit assemblies At the end of the useful life of the equipment it ...

Страница 8: ... for replacement The DYONICS POWERMINI Handpiece is not compatible with the DYONICS POWER Shaver System Suction is connected to a portal on the proximal end of the handpiece and removes fluid and debris drawn through the blade window In addition to removing fluids the suction cools and lubricates the motor drive Cutting takes place when the blade edge rotates across the blade s outer window The bl...

Страница 9: ... 7205357 REF 7205971 and REF 72201503 are hand held motor drives that are electrically connected to the control unit via a 10 foot 3 meter cable The non hand control handpieces are activated by a footswitch These handpieces run a variety of DYONICS Disposable Endoscopic Blades The handpieces are designed to sense the blade type installed and communicate that information to the control unit which s...

Страница 10: ...PM Range Default Range Default Range Default Range Default DYONICS POWER REF 7205354 7205355 Long Blades Straight and Curved TURBOWHISKER 100 3000 2000 100 3000 2000 500 3000 2000 1 9 1 Rev 1 8 2 Rev 8 2 Rev DYONICS POWERMAX REF 7210542 7210586 7209891 3 5 mm Curved Blade 100 3000 2000 100 3000 2000 500 3000 2000 1 9 1 Rev 1 8 2 Rev 8 2 Rev DYONICS POWERMAX ELITE REF 72200616 72200617 Curved HELIC...

Страница 11: ...sition of the inner blade relative to the opening at the top of the outer blade Hand Control Operation Press and hold the Oscillate button on the hand control handpieces for one second Footswitch Operation Press and hold the Window Lock button on the footswitch to rotate the blade When the blade is in the best stopping position for the procedure release the Window Lock button Control Unit Operatio...

Страница 12: ...ush in the device spigot proximal end of the device and clean the lumen using twisting and in out movements of the brush for a minimum of 30 seconds Reinsert the lumen brush from the distal end of the device end and clean the lumen from the opposite direction using twisting and in out movements of the brush for a minimum of 30 seconds Using the blade port brush clean the nose cavity using twisting...

Страница 13: ...uct returned that has been serviced by an unauthorized third party repair shop and or sterilized with a sterilization method other than one approved by Smith Nephew and or damaged by contact with other mechanical devices such as shavers may incur additional costs regardless of warranty status It is not necessary to include accessory items i e power cords etc when returning a device for service The...

Страница 14: ...s Forward Reverse Oscillate Blade Window Lock and Speed Shift Equipped with 10 foot 3 meter autoclavable power cord not field replaceable Suction control lever DYONICS POWERMAX and POWERMAX ELITE Handpieces REF 7210542 REF 72200616 REF 7220617 Length 7 1 18 0 cm Weight 7 5 oz 223 grams Lightweight handpiece with push button motor controls Forward Reverse Oscillate Blade Window Lock and Speed Shift...

Страница 15: ...eight 5 0 oz 142 grams Standard handpiece with push button motor controls Forward Reverse Oscillate Blade Window Lock Equipped with 10 foot 3 meter autoclavable power cord not field replaceable Suction control lever Allows for shaver blades to be inserted with the blade window aligned to the suction control lever or 180 opposite the lever Specifications subject to change without notice Handpiece d...

Страница 16: ... For a Return Authorization RA number or for additional information on this program call Customer Service at 1 800 343 5717 in the U S or contact your authorized representative 24 hour shipment is not offered in all countries Repair Service Program For devices no longer under warranty repairs can be made by Smith Nephew or by an authorized agent Non warranty repairs will be made at the list price ...

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