ent & cmf product catalog - fiagon · 2020. 3. 9. · e 01 5602 – navigation unit preparation and...

ENT & CMFPRODUCT CATALOG

fiagon ENT/CMF Catalog PN 450005 Rev E 3

REIMAGINING THE ROLE OF IMAGE GUIDANCE WITHIN SURGERY.VISION

We offer surgeons around the globe – in various specialties – the ability to provide safer patient care, more quickly and more efficiently.

We seek to expand our product offering and deepen our value proposition for physicians in the ENT, cranial, and spine markets through physician-focused approach of providing disruptive, innovative technologies. As we continue to grow, Fiagon will remain true to our founding principles, creating increasingly innovative methods of simplifying user experience for physician-focused navigation solutions.

OUR MISSION

Fiagon set out to reimagine how image guidance could support your procedures everyday– the routine and the complex. Today, Fiagon’s portfolio offers surgical solutions for offices, clinics and OR’s around the world, enabling your surgical excellence with easy-to-use, integrated navigation guidance.

FIAGON VALUES & COMMITMENTS

Provide consistent, reliable, and accurate navigation in every procedure• Sinus / Transsphenoidal Application• Ear / Otology Application• CMF / Plastic Reconstruction Application

Improve surgical navigation workflow by:• Integrating navigation sensor and navigation unit into the existing operating theater• Providing malleable instruments• Enabling the use of your favorite instruments with the versatile Fiagon PointerShell adapter

Provide surgeons greater control over procedures by offering:• Open platform• Malleable instrumentation• Versatile service support

Please be aware that this document does not replace an instruction for use.Local availability of products mentioned within this catalog depends on its regulatory approval.

I N T R O D U C T I O N

4 fiagon ENT/CMF Catalog PN 450005 Rev E

C A P I T A L E Q U I P M E N T

FIAGON NAVIGATION SETS

With our Fiagon Navigation Sets you have the possibility to order a predefined configuration of the Navigation System. You have the choice between our two system sets and the appropriate software packages. Additionally you need to choose a headrest and the instruments of your choice. After your selection you are free to add additional software features, further accessories and a suitable service offering, which you will find from Step 3 of this catalog.

Product Description

Fiagon Standard Navigation System

Set includes:

E 01 1103 Fiagon Navigation Unit incl. cables

E 01 2003 Registration Pointer

E 01 2202 Localizer Adhesive Pad

E 00 3001 Adhesive Pads

A 00 9101 PC Mouse

A 00 9102 Service Keyboard

A 01 1203 Double Instrument Support Cable (Y-Cable)

A 01 1000 Fiagon Navigation Sensor

E 01 4000 Sinus Navigation Software

E 01 4001 Ear Navigation Software

E 01 4002 Fusion Navigation Software

E 01 4003 Plastic Reconstruction Navigation Software

E 01 2200 Localizer Headband

E 01 3000 Headband

A 00 9100 Foot Switch

A 00 1200 Extension Cable Instrument

A 00 1201 Extension Cable Localizer

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Product Description

E 01 1903 NA Navigation OR Headrest Kit

Includes:

E 01 1003 – Navigation Headrest Universal

Compatible Adapters for OR tables (sold separately):

E 01 1913 – Adapter for Maquet Table

E 01 1914 – Adapter for Steris Table

E 01 1915 – Adapter for Eschmann Table

E 01 1916 – Adapter for OR Table Side Rails

E 01 1917 – Adapter for Mizuho and Skytron Tables

E 01 1918 – Adapter for Berchtold Table

E 01 1001 Navigation Headrest Flat

E 01 1002 Navigation Headrest Maquet

E 01 1009 Navigation Headrest Trumpf

E 01 1005 Navigation Headrest Horseshoe

E 01 1008 Navigation Headrest Office

Available adapters for Office Chairs (sold separately):

E 01 1960 – Chair Adapter A

E 01 1961 – Chair Adapter B

E 01 1962 – Chair Adapter C

E 01 1963 – Chair Adapter D

E 01 1964 – Chair Adapter E

E 01 1965 – Chair Adapter F

E 01 1966 – Chair Adapter R



CUSTOM NAVIGATION SYSTEM CONFIGURATION

If the preset configuration does not fit your needs you can choose the custom configuration of your choice in nine steps. Equiped with your Navigation Set continue with Step 3.

Step 1 System

Step 2 Patient Positioning

Step 3 Software Modules

Step 4 Software Add-ons

Step 5 Patient Registration

Step 6 Patient Localizers

Step 7 Instruments

Navigated Pointers

Navigated Suction Tubes

Navigated Guidewire

Navigated Adapters

Step 8 Accessories

Step 9 Service(s)


C U S T O M C O N F I G U R A T I O N – S Y S T E M

STEP 1 FIAGON STANDARD NAVIGATION SYSTEM

The stand-alone Standard Navigation System was designed for easy integration into your daily surgical routine. Setup your navigation system of choice with a wide range of options and instrumentation for ENT, Brain, and Spine Surgery.

Product Description

E 01 1103 Fiagon Standard Navigation System incl. cables


C U S T O M C O N F I G U R A T I O N – P A T I E N T P O S I T I O N I N G

STEP 2 PATIENT POSITIONING

Product Description

E 01 1903 NA Navigation OR Headrest Kit

Includes:

E 01 1003 – Navigation Headrest Universal

Compatible Adapters for OR tables (sold separately):

E 01 1913 – Adapter for Maquet Table

E 01 1914 – Adapter for Steris Table

E 01 1915 – Adapter for Eschmann Table

E 01 1916 – Adapter for OR Table Side Rails

E 01 1917 – Adapter for Mizuho and Skytron Tables

E 01 1918 – Adapter for Berchtold Table

E 01 1001 Navigation Headrest Flat

E 01 1002 Navigation Headrest Maquet

E 01 1005 Navigation Headrest Horseshoe

E 01 1009 Navigation Headrest Trumpf

E 01 1008 Navigation Headrest Office

Available adapters for Office Chairs (sold separately):

E 01 1960 – Chair Adapter A

E 01 1961 – Chair Adapter B

E 01 1962 – Chair Adapter C

E 01 1963 – Chair Adapter D

E 01 1964 – Chair Adapter E

E 01 1965 – Chair Adapter F

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C U S T O M C O N F I G U R A T I O N – S O F T W A R E M O D U L E S / S O F T W A R E A D D - O N S

STEP 3 SOFTWARE MODULES

We offer surgeons around the globe – in various specialties – the ability to provide safer patient care, more quickly and more efficiently.

Our physician-focused approach enables a versatile product offering for physicians in the ENT/CMF market. We increasingly create innovative methods of simplifying user experience for physician-focused navigation solutions. Fiagon offers solutions for rhinology and sinus surgery, otology and facial reconstructive surgery.

STEP 4 SOFTWARE ADD-ONS

Product Description

E 01 4002 Fusion Navigation Software

Automatic fusion of e.g. CT and MR images for sinus and ear surgeries

SINUS / TRANSSPHENOIDAL APPLICATION

Product Description

E 01 4000 Sinus Navigation Software

EAR / OTOLOGY APPLICATION

Product Description

E 01 4001 Ear Navigation Software

CMF / PLASTIC RECONSTRUCTION APPLICATION

Product Description

E 01 4003 Plastic Reconstruction Navigation Software


C U S T O M C O N F I G U R A T I O N – P A T I E N T R E G I S T R A T I O N

STEP 5 PATIENT REGISTRATION

TACTILE REGISTRATION

Product Description

E 01 2003 RegistrationPointer

RegistrationPointer

• Registration tool which features a ball tip for patient comfort and ease of use for the surgeon

• Not for surgical use• Non-sterile• Unlimited use

1

1


C U S T O M C O N F I G U R A T I O N – P A T I E N T L O C A L I Z E R S

STEP 6 PATIENT LOCALIZERS

Localizer Adhesive Pad

• Used for patient reference, this loca lizer provides surgeons with an effortless, non invasive alternative for fixation

• Fixed with the single use component Adhesive Pad

• Non- sterile• Unlimited use

Localizer Bone Anchor

• Bone anchored patient reference• Autoclavable• 50 times reusable• Compatible screws needed

1 2

Product Description

E 01 2202 Localizer Adhesive Pad

E 00 3001 – Adhesive Pads (10 pcs.)

E 01 2204 Localizer Bone Anchor

Check IFU for compatible screws

E 01 2200 Localizer Headband

E 01 3000 - Headband (1 pc.)

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C U S T O M C O N F I G U R A T I O N – I N S T R U M E N T S

STEP 7 NAVIGATED POINTERS

All products starting with a “Flex” in their names are malleable and can be bent. Please check the IFU for further information.

FlexPointer

• Ø 2.8 mm and 1.5 mm malleable ostium seeker designed for sphenoidal approaches

• Tip tracked• 10 times reusable• Bendable

GolfPointer

• For frontal approaches with smart sensor technology• Tip tracked• 10 times reusable

FinePointer

• Specially designed for Otology• Ø 1.5 mm• Tip tracked• 10 times reusable

12 2

Product Description

E 01 2002 FlexPointer

E 01 2004 FlexPointer 1.5 mm

E 01 2300 FinePointer

1

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STEP 7 NAVIGATED SUCTION TUBES

All products starting with a “Flex” in their names are malleable and can be bent. Please check the IFU for further information.

FlexTube

• The FlexTubes are suctions featuring Fiagon’s direct navigation

• Ø 3 mm suction• Ø 4 mm suction• Outlet in the handle

for variable suction capacity• Tip tracked• 10 times reusable• Bendable

PointerTube Keat

• Ø 3 mm suction• With olive tip• Tip tracked• 10 times reusable

PointerTube Kennedy

• Ø 4 mm suction• Outlet in the handle for variable

suction capacity• With olive tip• Tip tracked• 10 times reusable

1 2 3

Product Description

E 01 2104 FlexTube 3 mm

E 01 2106 FlexTube 4 mm

E 01 2107 PointerTube Keat

E 01 2108 PointerTube Kennedy

1

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STEP 7 GUIDEWIRE

Product Description

E 01 3913 Sterilized Single-Use GuideWire 0.6 mm 1

GuideWire

The GuideWire is ultra slim and completely flexible. This micro- wire was developed to navigate image-guided balloon sinuplasty devices.

• Ultra slim 0.6 mm• Completely flexible • Tip tracked

1



STEP 7 NAVIGATED ADAPTERS

Ø max. 5 mm

Ø min. 2.5 mm

Product Description

E 01 2904 PointerShell Universal

E 01 2902 PointerShell 3 mm



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PointerShell Universal

The inspiringly unique PointerShell Universal allows you to navi gate straight surgical instruments such as a shaver. It simply clamps around your instrument of choice, providing navigation after a quick calibration.

• Open platform technology with smart sensor tracking• Compatible with commonly available suctions, debrieders, ostium seekers,

and curettes with a diameter from 2.5 to 5 mm• 10 times reusable

1 PointerShell 4 mm 2


C U S T O M C O N F I G U R A T I O N – A C C E S S O R I E S

STEP 8 ACCESSORIES

Product Description

A 00 9100 Foot Switch

A 00 9103 Triple Foot Switch

E 01 3004 Sterile Drapes for iPad Remote Control

A 00 9101 PC Mouse

A 01 9102 Service Keyboard

A 01 1203 Double Instrument Support

A 00 1200 Extension Cable Instrument

A 00 1201 Extension Cable Localizer

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Extension Cable Instrument

• With a 2m extension cable for your localizer or your instruments you can set up your operation theatre according to your needs

Foot Switch

• Foot-pedal providing intraoperative control over your Fiagon Navigation System

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C U S T O M C O N F I G U R A T I O N – S E R V I C E ( S )

STEP 9 SERVICE(S)

Product Description

Installation & Support

E 01 5401 – System Installation Training

E 01 5411 – Surgery Support Day

E 01 5021 Network Connection & Installation

E 01 5421 – PACS Integration by Fiagon

E 01 5431 – Microscope Integration by Fiagon

E 01 5011 – Onsite Maintenance Visit

Maintenance

E 01 5000 – Maintenance by Fiagon

includes:

E 01 5500 – Safety Check

E 01 5510 – EM Inspection

Service Contract - Please check local availability

E 02 1000 – Service Contract Standard – Standard Navigation System

E 02 3000 – Service Contract Deluxe – Standard Navigation System

System Repair

E 01 5701 – System Diagnostic (System repair varies)


C U S T O M C O N F I G U R A T I O N – S E R V I C E ( S )

STEP 9 SERVICE(S)

Product Description

Loaner Product

E 01 5601 – Loaner Navigation Unit per Week (E 01 5602 additionally needed)

E 01 5602 – Navigation Unit Preparation and Configuration

E 01 5603 – Loaner Headrest or Navigation Sensor per Week

Demo Material

E 00 9301 – Phantom Head Demo

A 00 9901 – Fiagon Transport Case “Standard Navigation System”

A 00 9902 – Fiagon Transport Case “Head Rest”


E N T / C M F P O R T F O L I O

S E T S

Set E 01 0013 Fiagon Standard Navigation System – SinusSet E 01 0023 Fiagon Standard Premium Navigation System – ENT/CMF

S O F T W A R E

Software E 01 4000 Sinus Navigation SoftwareSoftware E 01 4001 Ear Navigation SoftwareSoftware E 01 4002 Fusion Navigation SoftwareSoftware E 01 4003 Plastic Reconstruction Navigation Software

I N S T R U M E N T S

Instruments E 01 2003 RegistrationPointerInstruments E 01 2002 FlexPointerInstruments E 01 2004 FlexPointer 1.5 mmInstruments E 01 2300 FinePointerInstruments E 01 2202 Localizer Adhesive PadInstruments E 01 2204 Localizer Bone AnchorInstruments E 01 2104 FlexTube 3 mmInstruments E 01 2106 FlexTube 4 mmInstruments E 01 2107 PointerTube KeatInstruments E 01 2108 PointerTube KennedyInstruments E 01 2904 PointerShell UniversalInstruments E 01 2902 PointerShell 3 mmInstruments E 01 2900 PointerShell 4 mmInstruments E 01 2901 PointerShell 5 mmInstruments E 01 3913 Sterilized Single-Use GuideWire 0.6 mm

A C C E S S O R I E S Accessories A 01 1000 Fiagon Navigation SensorAccessories A 01 2704 MapperFrameAccessories A 01 1310 Mapper TripodAccessories A 01 1401 iPad Remote ControlAccessories E 01 1103 Fiagon Standard Navigation SystemAccessories E 01 1003 Navigation Headrest UniversalAccessories E 01 1001 Navigation Headrest FlatAccessories E 01 1002 Navigation Headrest MaquetAccessories E 01 1009 Navigation Headrest TrumpfAccessories E 01 1005 Navigation Headrest HorseshoeAccessories E 01 1008 Navigation Headrest OfficeAccessories E 01 1960 Navigation Headrest Office Adapter AAccessories E 01 1961 Navigation Headrest Office Adapter BAccessories E 01 1962 Navigation Headrest Office Adapter CAccessories E 01 1963 Navigation Headrest Office Adapter DAccessories E 01 1964 Navigation Headrest Office Adapter EAccessories E 01 1965 Navigation Headrest Office Adapter FAccessories E 01 1966 Navigation Headrest Office Adapter RAccessories E 01 1914 Adapters for Steris TablesAccessories E 01 1915 Adapters for Eschmann TablesAccessories E 01 1913 Adapters for Maquet TablesAccessories E 01 1916 Adapters for Side RailsAccessories E 01 1917 Adapters for Mizuho/Skytron TablesAccessories E 00 3001 Adhesive Pads Accessories E 00 3000 Headband (50 pcs.)Accessories E 01 3000 Headband (1 pc.)

ENT/CMF PORTFOLIO


E N T / C M F P O R T F O L I O

A C C E S S O R I E S

Accessories A 00 1200 Extension Cable InstrumentAccessories A 00 1201 Extenstion Cable LocalizerAccessories A 01 1203 Double Instrument SupportAccessories A 00 1304 OR TrolleyAccessories A 00 1300 OR Trolley 24“ HDAccessories A 00 1303 24“ HD MonitorAccessories A 00 9100 Foot SwitchAccessories A 00 9101 PC MouseAccessories A 00 9102 Service KeyboardAccessories A 00 9103 Triple Foot SwitchAccessories A 21 9200 Power Cable (US)Accessories A 21 9201 Power Cord Hospital Grade (US)Accessories A 00 9201 DVI Monitor CableAccessories A 00 9203 VGA Monitor CableAccessories A 00 9204 Monitor Control CableAccessories A 00 9207 HDMI Monitor CableAccessories A 00 9208 Composite-Video CableAccessories A 00 9901 Fiagon Transport Case “Standard Navigation System”Accessories A 00 9902 Fiagon Transport Case “Headrest”Accessories E 00 9301 Phantom Head Demo ENT

S E R V I C E ( S )

Service(s) E 01 5000 Maintenance by Fiagon includes Safety Check (E 01 5500) and EM Inspection (E 01 5510)Service(s) E 01 5011 Onsite Maintenance VisitService(s) E 01 5021 Network Connection and InstallationService(s) E 02 1000 Service Contract Standard – Standard Navigation SystemService(s) E 02 3000 Service Contract Deluxe – Standard Navigation SystemService(s) E 01 5201 Fiagon Service Specialist Training at Fiagon FacilitiesService(s) E 01 5301 Fiagon Product Specialist Training at Fiagon FacilitiesService(s) E 01 5401 System Installation including InservicingService(s) E 01 5411 Surgery Support DayService(s) E 01 5421 PACS Integration by FiagonService(s) E 01 5601 Loaner Navigation Unit per WeekService(s) E 01 5602 Navigation Unit Preparation and ConfigurationService(s) E 01 5603 Loaner Navigation Sensor per WeekService(s) E 01 5701 System Diagnostics

Scan QR-code for further information or visit www.fiagon.com

Fiagon NA3913 Todd Ln. Suite 101Austin, Texas. 78744United States

[email protected]

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ent & cmf product catalog - fiagon · 2020. 3. 9. · e 01 5602 – navigation unit preparation and...

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