GENIUS concept

1

Index GENIUS concept

Appliances and accessories Page

GENIUS drive Shaver console, hand piece and foot switch 2 – 3

Range of GENIUS Shavers 4 – 5

GENIUS adapter for reprocessing 4 – 5

Reprocessing of instruments

Reprocessing of GENIUS Shaver Blades including GENIUS box 6 – 7

Reprocessing of GENIUS drive Shaver system 8

Reference numbers 9

22

GENIUS drive Shaver System

The complete GENIUS conceptThe GENIUS concept revolves around the practice tested Shaver Blades, a quality product designed for arthroscopy made by KOMET MEDICAL. In time, the Shaver Blades have been joined by a range of further clever products, such as a sterilisation case, a reprocessing device and detailed information on reprocessing.

KOMET MEDICAL has now added a new centre piece to the GENIUS quality concept:

a console set, composed of the controle unit, a hand piece and a foot switch. This new power system guarantees compatibility with KOMET MEDICAL’s reusable Shaver Blades.

KOMET MEDICAL is taking on a new direction as a full-line provider, thus eliminating the need for any other options – with KOMET MEDICAL, you no longer need to look anywhere else!

3

Technical data:

Sockets: 2 x hand piece, 1 x foot switch

Dimensions: 330 x 310 x 90 mmWeight: 5.5 kgInput voltage: 115 or 130 VAC,

50/60 HzPower consumption: 78 VADisplay: VFD 2 x 20 mmPrimary fuse: 2 x 1.6 ASafety class: IApplication part: Type BIP protection class: IPX0Reprocessing: Wet wipe disinfection,

front covered with foil to avoid shadows

· Sockets for two hand pieces· VFD display legible from every angle· Easy, self explanatory use· 5 languages to choose from· Speed settings in small intervals· Speed up to 8,000 rpm· Reliable speed transmission· Equipotentialization connector· Protection from over-currents· Easy cleaning and disinfection· Low-maintenance

Technical data:

Length: 170 mmWeight: 400 gSpeed: 800 – 8,000 rpmOscillating time: 0.3 – 1.2 secLength of cable: 3 mReprocessing: Mechanical cleaning

and disinfection, steam sterilisation

Length: 170 mmWeight: 400 gSpeed: 800 – 8,000 rpmOscillating time: 0.3 – 1.2 secLength of cable: 3 mReprocessing: Mechanical cleaning

· Light aluminium case· Ergonomic shape· Simple locking mechanism for quick exchange of the Shaver Blades: ➔ To lock: click into place under light pressure ➔ To unlock: Turn and remove Shaver Blade· The intensity of the suction can be regulated by means of the valve control. · Validated reprocessing of the hand piece to safely remove residues· Micro motor for optimum torque transmission· Guaranteed compatibility with KOMET MEDICAL Shaver Blades

 Hand piece

 Control unitSockets: 2 x hand piece,

1 x foot switchDimensions: 330 x 310 x 90 mmWeight: 5.5 kgInput voltage: 115 or 130 VAC,

50/60 Hz

· VFD display legible from every angle

Technical data:

Dimensions: 36 x 380 x 280 mmWeight: 1,800 gNumber of function keys: 5Functions: Clockwise and

anticlockwise rotation, oscillation, speed

Length of cable: 3 mReprocessing: Wet wipe disinfection

· Intuitive use of the individual buttons· Slightly touch the button to change parameters· The operator can choose ➔ The speed: in small intervals ➔ The direction: left/right/oscillating· Minimum speed: 800 rpm· Maximum speed: 8,000 rpm· All regulating buttons are placed at the foot pedal to allow free use of the

hand piece· The cable is attached in such a way that it allows the foot switch to be

carried by the cable· Easy cleaning and disinfection

 Foot switchDimensions: 36 x 380 x 280 mmWeight: 1,800 gNumber of function keys: 5Functions: Clockwise and

oscillation, speedLength of cable: 3 mReprocessing: Wet wipe disinfection

· Intuitive use of the individual buttons· Slightly touch the button to change parameters

The direction: left/right/oscillating

· All regulating buttons are placed at the foot pedal to allow free use of the

44

 GENIUSdrive Linvatec(FMS, Arthrex: REF AR8320F)

Diameter mm

3.5

4.2

5.5

4.2

3.5

4.2

5.5

3.5

4.2

5.5

4.2

4.2

5.5

6.5

5.5

6.5

5.5

GE0135.LI ■

GE0142.LI ■

GE0155.LI ■

GE0242.LI ■

GE0335.LI ■

GE0342.LI ■

GE0355.LI ■

GE0435.LI ■

GE0442.LI ■

GE0455.LI ■

GE0642.LI ■

GE0655.LI ■

GE0665.LI ■

GE0755.LI ■

GE0765.LI ■

GE0855.LI ■

Linvatec is a trademark of ConMed Corporation. Dyonics is a trademark of Smith & Nephew Inc.Aesculap is a trademark of Aesculap AG & Co. KG. Stryker is a trademark of Stryker Corporation. KOMET MEDICAL is not affiliated with any of the above.

) 6,000 rpm

01 = Aggressive      Meniscus Cutter

) 6,000 rpm

03 =  Full  Radius Resector

) 6,000 rpm

05 =  Bevel Edge Cutter

) 8,000 rpm

06 =  Round Bur

) 8,000 rpm

07 = Oval Bur

) 8,000 rpm

08 =  Tapered Bur

) 6,000 rpm

04 = Aggressive       Full Radius Resector

) 6,000 rpm

02 =  BiCut

 GENIUS adapter

 GENIUS Shaver Blades for GENIUS drive

· for validated reprocessing

Order numberGE 9101.LI –forGEXXX.LI-Shaver

5

 Dyonics EP1  Aesculap  Stryker 12K Diameter mm

3.5

4.2

5.5

4.2

3.5

4.2

5.5

3.5

4.2

5.5

4.2

4.2

5.5

6.5

5.5

6.5

5.5

GE0135.DY ■ GE0135.AC ■ GE0135.ST ■

GE0142.DY ■ GE0142.AC ■ GE0142.ST ■

GE0155.DY ■ GE0155.AC ■ GE0155.ST ■

GE0242.DY ■

GE0335.DY ■ GE0335.AC ■ GE0335.ST ■

GE0342.DY ■ GE0342.AC ■ GE0342.ST ■

GE0355.DY ■ GE0355.AC ■ GE0355.ST ■

GE0435.DY ■ GE0435.AC ■ GE0435.ST ■

GE0442.DY ■ GE0442.AC ■ GE0442.ST ■

GE0455.DY ■ GE0455.AC ■ GE0455.ST ■

GE0542.DY ■ GE0542.ST ■

GE0642.DY ■ GE0642.AC ■ GE0642.ST ■

GE0655.DY ■ GE0655.AC ■ GE0655.ST ■

GE0665.DY ■

GE0755.DY ■ GE0755.AC ■ GE0755.ST ■

GE0765.DY ■

GE0855.DY ■ GE0855.AC ■ GE0855.ST ■

Compatible with the following connections:

 GENIUS Shaver Blades for third-party systems

Order numberGE 9001.DY–forGEXXX.DY-Shaver

Order numberGE 9201.AC –forGEXXX.AC-Shaver

Order numberGE 9301.ST –forGEXXX.ST-Shaver

 GENIUS adapter

· for validated reprocessing

66

 Reprocessing of GENIUS Shaver Blades

9829

All KOMET MEDICAL Shaver Blades can be reprocessed according to a validated method.

KOMET MEDICAL Shaver Blades are thermostable and classified as “critical B” according to the guidelines of the Robert Koch Institute. This classification requires the observation of stricter reprocessing guidelines.

All Shaver Blades have to be submitted to a manual pre-cleaning process. All superficial contamination has to be removed with a water gun and a nylon brush.

This is followed by mechanical cleaning in the washer/ disinfector and steam sterilisation.

Mechanical disinfection takes place at 93°C, observing a hold time of 10 minutes in case of the effective ranges A and B.

To ensure proper rinsing of the narrow lumen of the Shaver Blades, GENIUSadapters should be used for reprocessing, in compliance with the validated reprocessing method. The individual tubes are gently fixed to the adapter and directly attached to the racks of the washer/disinfector by means of Luer-Lock screws.

We recommend an alkaline detergent/disinfectant for mechanical reprocessing. We used deconex 28 ALKA ONE (co. Borer Zuchwil) for the validation of our entire product range.

Packaging

Examination

Dry

ing

Ster

ilisa

tion

Stor

age

Usage

Pre-treatment

Disinfection/Cleaning

Newproducts

sterile one-way products

Disposal Subsequent cleaning

Order numbers GENIUS adaptersGE 9001.DY – compatiblewithDyonicsGE 9101.LI – compatiblewithLinvatecGE 9201.AC  – compatiblewithAesculapGE 9301.ST – compatiblewithStryker

 Mechanical cleaning / disinfection

7

9835M – GENIUS box:

It is absolutely essential to thoroughly check the Shaver Blades prior to every use to ensure their operational capability. Carefully examine the surfaces of the instrument, the quality of its blades and its proper function. GENIUS Shaver Blades must always be completely replaced. Partial replacement of individual components must be avoided under any circumstances.

The inner tube of the GENIUS Shaver Blades should be lubricated with an oil spray to minimise friction in the inner tube. The inner tube should be sprayed from a distance of approx. 20 cm. As soon as the inner tube rotates in the tro-car, an even film forms between the inner and outer tube, significantly reducing metal abrasion.

To help you assess the functional ability of the Shaver Blades, we have summa-rized the relevant guidelines in a check list.

Steam sterilisation at 134°C with fractioned pre-vacuum is the safest method and should be preferred over all other methods of sterilisation.

The GENIUSbox made by KOMET MEDICAL is recommended for transport and sterilisation to protect the sensitive instruments from external factors.

For detailed information, please refer to the information on validated repro-cessing provided by KOMET MEDICAL, our separate reprocessing brochure and/or our instructions for use!

Note:

The ZSVA check list can be downloaded from our website www.kometmedical.de

Check list

Magnifying glass, 8 times magnified

Visual control;Magnifying glass if necessary, 8 times magnified

Functional test:The outer tube of the ShaverBlade is locked onto the innertube and set in rotary motion with a finger

� Not clean �� Free from defects �

� Fracture �� Free from defects �

� Metal abrasion �� Free from defects �

� Corrosion �

� Free from defects �

� Difficult to rotate

� Free from defects �

� Additional cleaning cycle

☺

� Disposal

☺

� Disposal

☺

� Special cleaning

� Disposal

☺

� Additional cleaning cycle

� Disposal

☺

Inspection

Impurities

Fracture or damage to inner or outer blades

Obvious or hidden metal abrasion: the instrument is blunt

Residual corrosion is to be subjected to a special cleaning cycle. Advanced corrosion (e.g. pitting corro-sion), as a result of which resistance to fracture can no longer be guaranteed, inevitably leads to the dis-posal of the instrument.

Difficult to rotate: low-vibration operation or properchucking in the motor can no longer be guaranteed. Check whether the preceding cleaning cycle has beensuccessful (=> additional cleaning) or if there is anybending ( => disposal).

Defects

Cleanliness

Surface

Form and Function

Protocol Action

Check list of the Sterile Services Department - GENIUS Shaver Blades*

A visual control and a functional test must be carried out at the end of each cleaning and disinfecting pro-cess to ensure that the instruments are macroscopically clean and that damaged instruments are discardedbefore being reintegrated in the preparation cycle (see reverse of page). The characteristics listed belowdetermine the next step, i.e.

� Packing � An additional cleaning cycle � Disposal

* KOMET MEDICAL GENIUS Shaver Blades are reusable, which is why it is particularly important to treatthe instruments with care during use and reprocessing. Use Shaver Blades without pressure and observethe optimal speed.

Download this information from our website www.kometmedical.de !

If the verdict in all categories is “free from defects”, the instrument is ready for sterilisation and can be packed in sterilisation foil or boxes. To ensure low friction, apply suitable lubricating oil to the inner blade of the GENIUS Shaver Blade.

only if ☺☺☺☺☺ � � Packing/sterilisation

 Examination

 Sterilisation

88

 Reprocessing of the Shaver System GENIUS drive

 Foot switch and control unit

 Hand piece

The individual components of the Shaver system have to be reprocessed prior to every use. The foot switch and the control unit are cleaned and disinfected, whereas the hand piece has to be mechanically cleaned, disinfected and steril-ised.

Prior to mechanical cleaning and disinfection, the hand piece must be submit-ted to a manual cleaning process. Rinse the receiving ring and the extraction canal with a water gun to make sure that all contamination is removed. Use a nylon brush to enhance the cleaning effect.

Mechanical cleaning and disinfectionOnly the hand piece can be reprocessed mechanically.

The pre-cleaning process is followed by another cleaning cycle and disinfection in the washer/disinfector, for which we recommend the detergent neodisher mediclean forte (co. Dr. Weigert). Disinfection takes place at a temperature of 93°C (hold time: 10 min.).

Make sure that the receiver for the Shaver Blade faces downwards at all times.

Sterilisation Steam sterilisation at 134°C with fractioned pre-vacuum is the safest method and should be preferred over all other methods of sterilisation. Steam sterilisation is the only permissible method of sterilisation. All other methods are prohibited.

The appropriate disinfection method for reprocessing the control unit and the foot switch is the wet wipe method. A soft cloth moistened with a cleaning and disin-fection solution is used to remove all surface contamination. The construction of the case of the Shaver control unit and the foot switch allows easy access to all parts of the case with the wet cloth. The front of the control unit is a continuous surface, the only openings being the sockets for connecting the hand pieces and the foot switch. Do not allow any moisture to enter these sockets.

Make sure to clean and disinfect the set/the individual components after delivery, prior to first use.

9

 Reference numbers

GENIUS drive power system and accessories

GENIUS drive power system Complete set GE9501 Control unit Foot switch Hand piece Network cable

Control unit GE9501.CUFoot switch GE9501.FSHand piece Shaver Blade GE9501.SH

Reusable GENIUS Shaver Blades Aggressive Meniscus Cutter 3.5 mm GE0135.LI Aggressive Meniscus Cutter 4.2 mm GE0142.LIAggressive Meniscus Cutter 5.5 mm GE0155.LI BiCut 4.2 mm GE0242.LI Full Radius Resector 3.5 mm GE0335.LI Full Radius Resector 4.2 mm GE0342.LI Full Radius Resector 5.5 mm GE0355.LI Aggressive Full Radius Resector 3.5 mm GE0435.LI Aggressive Full Radius Resector 4.2 mm GE0442.LI Aggressive Full Radius Resector 5.5 mm GE0455.LI Round Bur 4.2 mm GE0642.LI Round Bur 5.5 mm GE0655.LI Round Bur 6.5 mm GE0665.LI Oval Bur 5.5 mm GE0755.LI Oval Bur 6.5 mm GE0765.LI Tapered Bur 5.5 mm GE0855.LI Shavers for third-party systems, see pages 4 – 5

GENIUS adapter for reprocessing   

Adapter for GEXXXX.LI-Shaver Blade GE9101.LIAdapter for GEXXXX.DY/AC/ST see pages 4 – 5

Accessories

Transport case for the complete set GE9501.SCGENIUS box 9835.M

Please refer to our website www.kometmedical.de for: Validated information provided by KOMET MEDICAL on appropriate reprocessing of the GENIUS Shaver BladesZSVA check list for correct inspection of the GENIUS Shaver Blades

© 03/2009 · GEBR. BRASSELER · Germany · Printed in Germany · GD/0 · 404598V0

GEBR. BRASSELER GmbH & Co. KGTrophagener Weg 25 · 32657 LemgoPostfach 160 · 32631 Lemgo · Germany

Phone +49 (0) 5261 701-400Telefax +49 (0) 5261 701-580info@kometmedical.dewww.kometmedical.de

© 04/2009 · GEBR. BRASSELER · Germany · Printed in Germany · GD/0 · 404699V0

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