product catalogue - sanovamedicalsystems.sanova.at/download/kryoablation/kryo_produktkatalog… ·...

ProductCATALOGUE

2013

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Mission Statement

Galil Medical is a global leader in delivering

innovative cryotherapy solutions. Our

technologies are delivered through multiple

physician specialties; we are focused on

conditions that affect the bone, kidney, liver,

lung and prostate as well as targeted pain

applications.

Vision

Committed to improving lives, while leading

through innovation.

Contact Galil Medical Customer Service at: +1 877 639 2796 or [email protected]

CUSTOMER SERVICE OVERVIEW

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Galil Medical develops, manufactures and distributes cryoablation systems and disposable products for minimally invasive, image-guided tissue ablation.

We aim to build a rewarding relationship with all our customers and are continually working on ways of improving our products and services to support your needs. We maintain a customer service process to ensure that our products and services meet your requirements.

CUSTOMER SERVICEGalil Medical, our agents and distributors are able to offer support at many levels to our customers, from the installation and maintenance of systems through to the clinical application training of staff who will come into contact with the system. Galil has a network of highly trained clinical personnel and technical specialists who are dedicated to supporting our customers at all stages of the setup during the initial procedure(s) and at any stage thereafter.

PRODUCT ORDERINGEach product number is composed of an alphanumeric designation. Please use the entire alphanumeric numbers when ordering. Orders may be submitted via these ordering methods:

Galil Medical Customer Service Department (For EU Distributors only)Email: [email protected]: +1 877 510 7757Toll Free: +1 877 639 2796Telephone: +1 651 287 5000

DISTRIBUTORS IN YOUR AREAPlease call Galil Medical’s Customer Service Department at +1 877 639 2796 Product Sales and Returns:All sales are governed by Galil Medical’s Standard Terms and Conditions (see www.galilmedical.com) or by specific contract.

We look forward to serving you.Galil Medical Customer Service Department

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Ultrasound & CT ImagingImaging

Needles

MR Imaging

The product numbers for the procedure kits, cryoablation needle kits, and thermal sensor kits start with FPRPR; use the entire alphanumeric product numbers when ordering products. • All needles are helium thaw.* In addition to helium thaw, IceRod® 1.5 CX and IceRod® 1.5 i-Thaw® Needles feature i-Thaw® technology for helium-free, active thawing.• i-Thaw® needles can only be used with the Visual-ICE® Cryoablation System and the Presice® Cryoablation System.• CX needles can only be used with the Visual-ICE® Cryoablation System.• Materials appropriate for use in an MR environment are: MRI needle kits and MRI SeedNet® Gold Cryoablation System (FPRCH2035).

PROSTATE PROCEDURE KITS

CRYOABLATION NEEDLES

IceSeed®

He-Thaw He-Thaw i-Thaw®

IceSeed® 1.5 3201 3202 3192 3194

IceSphere® 1.5 3258 3260 N/A N/A

IceRod® 1.5 3203 3204 3193 3195

IceRod® 1.5 PLUS 3510 3508 N/A N/A

IceRod® 1.5 CX* N/A 3533 N/A N/A

IceRod® 1.5 i-Thaw® * 4009 N/A N/A N/A

IceEDGE® 2.4 N/A 3506 N/A N/A

IceBulb® 1.5 400mm 3259 N/A N/A N/A

Straight 90 Degree Straight 90 Degree

System

FPRCH2047

FPRCH2024

IceRod®

4518 4570 4070

4518 4570 4070

3008 3070 N/A

FPRCH6000

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Visual-ICE® Accessories EZ Connect2™ Dual Cylinder Adapter FRPCH4000

Argon Supply Line (8 m) FPRCH6100

Helium Supply Line (8 m) FPRCH6101

Chassis Cover FPRCH6112

Not Pictured: Argon Supply Line (3 m), FPRCH6103 Helium Supply Line (3 m), FPRCH6105Gas Supply Line (8 m), FPRCH6108Gas Supply Line (3 m), FPRCH6109USB Flash Drive, FPRCH6110Ethernet Cable, FPRCH6111Wrench, FPRCH6114Argon Auxiliary Line (3 m), FPRCH6115 Wrench Pouch, FPRCH6116

Accessories Urethral Warming Set FPRPR4003

Golden SmartCard™ / Presice® SPR000066

Other ScanCard™/ SeedNet® SPR000083

Prostate Procedure Template SPR000018

Single-Point™ Thermal Sensors are sold in packs of 10. Multi-Point™ Thermal Sensors are sold in single needle packs.

ACCESSORIES

Single-Point™Thermal Sensors

N/A N/A 4010

3212 3206 4010

3212 3206 N/A

90 Degree

Single-Point™Multi-Point™

FPRCH2047 Presice® Cryoablation System

FPRCH6000 Visual-ICE® Cryoablation System

FPRCH2024 SeedNet® GoldCryoablation System


PRODUCT NUMBER PRODUCT NAME DESCRIPTION

The Visual-ICE® Cryoablation System is the first cryoablation system introduced in over six years. State of the art software and technology provide the user with enhanced intra-procedural precision and control and intuitive, simplified operation. This system leverages use of the company’s proprietary argon-only i-Thaw® needle technology and is the platform for advanced needle designs, including needles with cautery for track ablation.

This system can be used with ultrasound and CT imaging systems, supports the use of up to 20 cryoablation needles (on 10 independently controlled channels) and four Multi-Point Thermal Sensors™.

The Visual-ICE System, customized to local language and electrical requirements, includes built-in gas pressure regulators, flexible 8 m argon and helium gas supply lines (each with an attached pressure gauge), 28 mm wrench, USB flash drive, Ethernet cable, local language User Manual and local language Quick Reference Guide.

FPRCH6000

Visual-ICE® Cryoablation System

CRYOABLATION SYSTEM

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Prostate Procedure Kits


PROCEDURE KITS

FPRPR3008 IceSeed® Prostate Kit/ 14 IceSeed® 1.5 mm Cryoablation Needle Presice® System 2 Single-Point Thermal Sensors™ SeedNet® System 1 Urethral Warming Set 1 Prostate Procedure ScanCard™ 2 Kit identification labels

FPRPR3070 IceRod® Prostate Kit/ 8 IceRod® 1.5 mm Cryoablation Needle SeedNet® System 5 Single-Point Thermal Sensors™ Presice® System 1 Urethral Warming Set 1 Prostate Procedure ScanCard™ 2 Kit identification labels

FPRPR4518 IceSeed® Prostate Kit/ 14 IceSeed® 1.5 mm Cryoablation Needle Visual-ICE® System 2 Multi-Point Thermal Sensors™ Presice® System 1 Urethral Warming Set 1 Prostate SmartCard™ 2 Kit identification labels

FPRPR4070 IceRod® i-Thaw Prostate Kit/ 8 IceRod® 1.5 mm i-Thaw® Cryoablation Needle Visual-ICE® System 2 Multi-Point Thermal Sensors™ Presice® System 3 Single-Point Thermal Sensors™ 1 Urethral Warming Set 1 Prostate SmartCard™ 2 Kit identification labels

FPRPR4570 IceRod® Prostate Kit/ 8 IceRod® 1.5 mm Cryoablation Needle Visual-ICE® System 2 Multi-Point Thermal Sensors™ Presice® System 3 Single-Point Thermal Sensors™ SeedNet® System 1 Urethral Warming Set 1 Prostate SmartCard™ 2 Kit identification labels

MRI Procedure Kits

IceSeed® 1.5 MRI Cryoablation Needle Kits

FPRPR3192 IceSeed® 1.5 MRI Needle/ 1 IceSeed® 1.5 mm Cryoablation Needle MRI SeedNet® System 1 Other ScanCard™ 2 Kit identification labels

FPRPR3194 IceSeed® 1.5 90˚ MRI Needle/ 1 IceSeed® 1.5 mm 90˚ Cryoablation Needle MRI SeedNet® System 1 Other ScanCard™ 2 Kit identification labels

IceRod® 1.5 MRI Cryoablation Needle Kits

FPRPR3193 IceRod® 1.5 MRI Needle/ 1 IceRod® 1.5 mm Cryoablation Needle MRI SeedNet® System 1 Other ScanCard™ 2 Kit identification labels

FPRPR3195 IceRod® 1.5 90˚ MRI Needle/ 1 IceRod® 1.5 mm 90˚ Cryoablation Needle MRI SeedNet® System 1 Other ScanCard™ 2 Kit identification labels

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MRI CRYOABLATION NEEDLES




IceSeed® 1.5 Cryoablation Needle Kits

FPRPR3201 IceSeed® 1.5 Needle/ 1 IceSeed® 1.5 mm Cryoablation Needle Visual-ICE® System, 1 Other ScanCard™ Presice® System, 1 Golden SmartCard™ SeedNet® System 2 Kit identification labels

FPRPR3202 IceSeed® 1.5 90˚ Needle/ 1 IceSeed® 1.5 mm 90˚ Cryoablation Needle Visual-ICE® System, 1 Other ScanCard™ Presice® System, 1 Golden SmartCard™ SeedNet® System 2 Kit identification labels

IceSphere® 1.5 Cryoablation Needle Kits

FPRPR3258 IceSphere® 1.5 Needle/ 1 IceSphere® 1.5 mm Cryoablation Needle Visual-ICE® System, 1 Other ScanCard™ Presice® System, 1 Golden SmartCard™ SeedNet® System 2 Kit identification labels

FPRPR3260 IceSphere® 1.5 90˚ Needle/ 1 IceSphere® 1.5 mm 90˚ Cryoablation Needle Visual-ICE® System, 1 Other ScanCard™ Presice® System, 1 Golden SmartCard™ SeedNet® System 2 Kit identification labels

IceBulb® 1.5 Cryoablation Needle Kit

FPRPR3259 IceBulb 1.5 400 mm Needle/ 1 IceBulb 1.5 mm 400 mm Cryoablation Needle Visual-ICE® System, 1 Supporting sleeve Presice® System, 1 Other ScanCard™ SeedNet® System 1 Golden SmartCard™ 2 Kit identification labels

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ISOTHERMDATA

0° C -20° C -40° C

IceSphere®

1.5 mm

39mm x 47mm26mm x 35mm16mm x 25mm

IceSeed®

1.5 mm


IceRod®

1.5 mm


IceRod® CX1.5 mm


IceEDGE® | 2.42.4 mm


IceRod® PLUS1.5 mm


±3mm width±4mm length

-40° C-40° C

0° C0° C-20° C-20° C

-40° C-40° C-40° C-40° C

0° C0° C0° C0° C-20° C-20° C-20° C-20° C




IceRod® 1.5 Cryoablation Needle Kits

FPRPR3203 IceRod® 1.5 Needle/ 1 IceRod® 1.5 mm Cryoablation Needle Visual-ICE® System, 1 Other ScanCard™ Presice® System, 1 Golden SmartCard™ SeedNet® System 2 Kit identification labels

FPRPR3204 IceRod® 1.5 90˚ Needle/ 1 IceRod® 1.5 mm 90˚ Cryoablation Needle Visual-ICE® System, 1 Other ScanCard™ Presice® System, 1 Golden SmartCard™ SeedNet® System 2 Kit identification labels

FPRPR3508 IceRod® 1.5 PLUS 90˚ Needle/ 1 IceRod® 1.5 mm PLUS 90˚ Cryoablation Needle Visual-ICE® System, 1 Other ScanCard™ Presice® System, 1 Golden SmartCard™ SeedNet® System 2 Kit identification labels

FPRPR3510 IceRod® 1.5 PLUS Needle/ 1 IceRod® 1.5 mm PLUS Cryoablation Needle Visual-ICE® System, 1 Other ScanCard™ Presice® System, 1 Golden SmartCard™ SeedNet® System 2 Kit identification labels

FPRPR3533 IceRod® 1.5 CX 90˚ Needle/ 1 IceRod® 1.5 mm CX 90˚ Cryoablation Needle Visual-ICE® System, 1 Other ScanCard™ Presice® System 1 Golden SmartCard™ 2 Kit identification labels

FPRPR4009 IceRod® 1.5 i-Thaw® Needle/ 1 IceRod® 1.5 i-Thaw® Cryoablation Needle Visual-ICE® System, 1 Other ScanCard™ Presice® System, 1 Golden SmartCard™ SeedNet® System 2 Kit identification labels

IceEDGE® 2.4 Cryoablation Needle Kit

FPRPR3506 IceEDGE® 2.4 90˚ Needle/ 1 IceEDGE® 2.4 mm 90˚ Cryoablation Needle Visual-ICE® System, 1 Other ScanCard™ Presice® System, 1 Golden SmartCard™ SeedNet® System 2 Kit identification labels

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0° C

ACCESSORIES FPRPR4003 Urethral Warming Set 1 Urethral warming set that includes: Flexible warmer cassette Urethral warming catheter with warming tubing #1 and #2 Warmer tubing #3 2 Kit identification labels

SPR000018 Prostate Procedure Template 1 Prostate procedure template (non-sterile)

SPR000066 Golden SmartCard™ / 1 Golden SmartCard™ Presice®

SPR000083 ScanCard™ / 1 Other ScanCard™ SeedNet® Gold

Visual-ICE® AccessoriesFRPCH4001 EZ CONNECT2™ 1 Dual cylinder adapter set, consists of: Dual Cylinder Adapter One 8 m high pressure gas supply line connected to a four-way adapter with an argon pressure gauge (psi) with blue rubber sleeve One 3 m high pressure gas supply line with quick connect fittings

FPRCH6100 Argon Supply Line (8 m) 1 8 m argon supply line with an attached argon pressure gauge (bar) with blue rubber sleeve

FPRCH6101 Helium Supply Line (8 m) 1 8 m helium supply line with an attached helium pressure gauge (bar) with red rubber sleeve

FPRCH6103 Argon Supply Line (3 m) 1 3 m argon supply line with an attached argon pressure gauge (bar) with blue rubber sleeve

FPRCH6105 Helium Supply Line (3 m) 1 3 m helium supply line with an attached helium pressure gauge (bar) with red rubber sleeve

FPRCH6108 Gas Supply Line (8 m) 1 8 m gas supply line

FPRCH6109 Gas Supply Line (3 m) 1 3 m gas supply line

FPRCH6110 USB Flash Drive 1 USB flash drive

FPRCH6111 Ethernet Cable 1 Ethernet cable (3 m)

FPRCH6112 Chassis Cover 1 Nylon chassis cover

FPRCH6114 Wrench (28 mm) 1 Wrench (28 mm)

FPRCH6115 Argon Auxiliary Line (3 m) 1 Argon auxiliary gas supply line

FPRCH6116 Wrench Pouch 1 Canvas wrench pouch



THERMAL SENSOR KITSSingle-Point Sensors™

FPRPR3212 Thermal Sensor 10 Single-Point Thermal Sensors™ MultiPack/ 2 Kit identification labels Presice® & SeedNet®

FPRPR3206 90˚ Thermal Sensor 10 90˚ Single-Point Thermal Sensors™ MultiPack/ 2 Kit identification labels Presice® & SeedNet®

Multi-Point Sensors™

FPRPR4010 Multi-Point Thermal 1 Multi-Point Thermal Sensor™ Sensor/ 2 Kit identification labels Visual-ICE® & Presice®

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CRYOABLATION SYSTEM


THERMAL SENSORSMulti-Point Thermal Sensor™ 90˚ Single-Point Thermal Sensor™Single-Point Thermal Sensor™


© 2013 Galil Medical, Inc. | MOG10-CRP35-03 | April 2013

www.galilmedical.com

[email protected]

Galil Medical Inc.4364 Round Lake Road

Arden Hills, MN 55112

USA

Tel: +1 651 287 5000

+1 877 639 2796

Fax: +1 651 287 5199

+1 877 510 7757

Galil Medical Ltd.Tavor Building 1

Yokneam

Israel 20692

Tel: +972 (4) 9093200

Fax: +972 (4) 9591077

Indications for Use:The Galil Medical Cryoablation Systems are intended for cryogenic destruction of tissue during surgical procedures; various Galil Medical ancillary products are required to perform these procedures. Galil Medical Cryoablation Systems are indicated for use as a cryosurgical tool in the fields of general surgery, dermatology, neurology (including cryoanalgesia), thoracic surgery, ENT, gynecology, oncology, proctology and urology. These Systems are designed to destroy tissue (including prostate and kidney tissue, liver metastases, tumors, skin lesions and warts) by the application of extremely cold temperatures. A full list of specific indications can be found in the Galil Medical Cryoablation System User Manuals.

Contraindications: There are no known contraindications.

Warnings / Precautions / Adverse EventsA thorough understanding of the technical principles, clinical applications, and risks associated with cryoablation procedures is necessary before using Galil Medical products to conduct cryoablation. Use of such products should be restricted to use by or under the supervision of physicians trained in cryoablation procedures with a Galil Medical Cryoablation System.

A full list of the warnings, precautions, and adverse events can be found by referencing the respective device Instructions for Use document or Cryoablation System User Manual.

Rx only

Product CATALOGUE

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