Instructions for Use
GALIL MEDICAL SCANCARD™ INSTRUCTIONS FOR USE
CAUTION: Federal (USA) law restricts this device to sale by or on the order of a physician.
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This document provides instructions for use and recommended guidelines exclusively for the ScanCard supplied by Galil Medical. This document is provided as an addendum to the User Manual supplied with each SeedNet® Cryoablation System. The system User Manual should be relied on for detailed information regarding the operation of Galil Medical's SeedNet® Cryoablation System and accessories.
Table of Contents 1 Product Description... 1 1.1 Intended Use... 1 1.2 Technical Description... 1 2 How Supplied... 1 3 Indications for Use... 2 4 Contraindications... 2 5 Warnings... 2 6 Precautions for Handling... 2 7 Potential Adverse Events... 3 8 Directions for Use... 3 9 DISCLAIMER OF WARRANTY... 4
1 Product Description 1.1 Intended Use Galil Medical’s ScanCard™, a component used in conjunction with a Galil Medical SeedNet® Cryoablation System when performing cryogenic destruction of tissue, is intended to simplify the step required to authenticate the SeedNet System's operation of the selected procedure.
1.2 Technical Description The ScanCard is a paper card containing barcodes for the operation of a specific SeedNet cryoablation procedure. Fig 1 depicts the Prostate Procedure ScanCard.
Fig 1. ScanCard - Prostate Procedure The SeedNet Cryoablation System is equipped with a Barcode Reader, a hand-held device used to automatically read barcode numbers from a ScanCard. See Directions for Use, Section 8.
2 How Supplied The ScanCard is supplied exclusively by Galil Medical. NOTE: The Galil Medical SeedNet Cryoablation System (with Barcode Reader) is supplied separately. ScanCard™
• Storage Store in the original container in a cool, dry place.
3 Indications for Use The Galil Medical ScanCard is intended for use only with a Galil Medical SeedNet Cryoablation System. 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 respective Galil Medical Cryoablation System User Manuals.
4 Contraindications There are no known contraindications for using the Galil Medical ScanCard.
5 Warnings • Do not use this device for any purpose other than the stated intended use. • A thorough understanding of the technical principles, clinical applications, and risk associated with cryoablation procedures is necessary before using this product. Use of this device should be restricted to use by or under the supervision of physicians trained in cryoablation procedures with a Galil Medical Cryoablation System. • BEFORE THE PATIENT IS ANESTHETIZED, Integrity and Functionality Tests on the Cryoablation Needles and Thermal Sensors must be completed successfully.
6 Precautions for Handling • Do not use a ScanCard if the integrity of the barcodes has been damaged; in the event of such occurrence, contact a Galil Medical representative to arrange return of the product. • In the event of power loss during a procedure, barcodes scanned for the procedure will remain valid for a period up to 60 minutes. Consult the SeedNet System User Manual for restart instructions, or contact your nearest Galil Medical representative.
Instructions for Use
7 Potential Adverse Events There are no known adverse events related to the specific use of the Galil Medical ScanCard. There are, however, potential adverse events associated with any surgical procedure. Potential adverse events which may be associated with the use of cryotherapy may be organ specific or general and may include, but are not limited to abscess, adjacent organ injury, allergic/anaphylactoid reaction, angina/coronary ischemia, arrhythmia, atelectasis, bladder neck contracture, bladder spasms, bleeding/hemorrhage, creation of false urethral passage, creatinine elevation, cystitis, diarrhea, death, delayed/non healing, DVT, ecchymosis, edema/swelling, ejaculatory dysfunction, erectile dysfunction (organic impotence), fever, fistula, glomerular filtration rate elevation, hematoma, hematuria, hypertension, hypotension, hypothermia, idiosyncratic reaction, ileus, impotence, infection, injection site reaction, myocardial infarction, nausea, neuropathy, obstruction, pain, pelvic pain, pelvic vein thrombosis, penile tingling/numbness, perforation GU, perirenal fluid collection, pleural effusion, pneumothorax, probe site paresthesia, prolonged chest tube drainage, prolonged intubation, pulmonary embolism, pulmonary failure, rectal pain, renal artery/renal vein injury, renal capsule fracture, renal failure, renal hemorrhage, renal infarct, renal obstruction, renal vein thrombosis, rectourethral fistula, scrotal edema, sepsis, skin burn/frostbite, stricture of the collection system or ureters, stroke, thrombosis/thrombus/embolism, transient ischemic attack, tumor seeding, UPJ obstruction/injury, urethral sloughing, urethral stricture, urinary fistula, urinary frequency/urgency, urinary incontinence, urinary leak, urinary renal leakage, urinary retention/ oliguria, urinary tract infection, vagal reaction, voiding complication including irritative voiding symptoms, vomiting, wound complication, and wound infection.
8 Directions for Use 1. Hold the Barcode Reader over the ScanCard, with the scanning area in close proximity to the Reader to enable the system to capture the barcode number (Fig 2). Barcode Reader
Fig 2. Reading the ScanCard with the Barcode Reader ScanCard™
2. Scan each barcode on the ScanCard. Successful capture of the barcode number is displayed on the SeedNet System screen. NOTE: For detailed information on manually entering barcode numbers, as well as on-screen instructions, refer to the SeedNet Cryoablation System User Manual.
9 DISCLAIMER OF WARRANTY Although reasonable care has been used in the design and manufacture of this product, Galil Medical has no control over conditions under which this product is used. GALIL MEDICAL, THEREFORE, DISCLAIMS ALL WARRANTIES WHETHER EXPRESSED OR IMPLIED, WRITTEN OR ORAL, INCLUDING BUT NOT LIMITED TO ANY WARRANTIES OF MERCHANTABILITY OF FITNESS FOR A PARTICULAR PURPOSE. GALIL MEDICAL SHALL NOT BE LIABLE FOR ANY DIRECT, INDIRECT, INCIDENTAL OR CONSEQUENTIAL LOSS, DAMAGE, OR EXPENSE ARISING FROM OR RELATED TO THE USE OF THIS DEVICE.
Instructions for Use
For assistance, contact: www.galilmedical.com USA:
Galil Medical Inc., 4364 Round Lake Road, Arden Hills, MN 55112, USA. Telephone: +1 877 639 2796, Fax: +1 877 510 7757
Galil Medical UK Ltd., The Office Building, Suite 21, Gatwick Road, Manor Royal, Crawley, West Sussex RH10 9RZ, United Kingdom. Telephone: +44 (0) 1 293 459848, Fax: +44 (0) 1 293 459840 Galil Medical (Israel) Ltd., Industrial Park, Tavor Building 1, Yokneam 20692, Israel. Telephone: +972 (4) 9093200, Fax: +972 (4) 9591077 Obelis s.a., Boulevard Général Wahis 53, 1030 Brussels, Belgium. Telephone: +32 2 732 59 54, Fax: +32 2 732 60 03, E-mail: [email protected]
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