IceCure FAP 7100000 Instructions For Use

Instruction for Use: Cryoprobe
The information in this document is confidential and is intended
only for use of the recipient. Unauthorized use, duplication,
publication or disclosure is strictly prohibited. If you have received
this document in error, please notify IceCure Medical immediately.
Before using the IceCure Cryoablation system with its accessories
you must read and fully understand the IceCure Cryoablation
system User Manual (for IceSense3® or ProSense®). While this
document is designed to provide instructions in the use of the
cryoprobe with IceCure Cryoablation system, it is not intended to
take the place of the User Manual and of the user training course
which must be completed before using the system.
Intended use of IceCure Cryoablation System
(IceSense3® or ProSense®)
IceCure Cryoablation system is intended for cryogenic destruction
of tissue during surgical procedures by the application of extreme
cold temperatures. The IceCure Family device is 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. The system is
designed to destroy tissue by the application of extreme cold
temperatures including prostate and kidney tissue, liver
metastases, tumors, skin lesions, and warts. The IceCure Family
device, including the ProSense cryoablation system may be used
with an ultrasound device to provide real-time visualization of the
cryosurgical procedure.
The system is suitable for use in a number of cryotherapy
applications. However, it is ONLY indicated for use in patients
whom the practitioner has deemed eligible for cryotherapy.
Indications for Use
The IceCure Family cryoablation system is intended for cryogenic
destruction of tissue during surgical procedures by the application
of extreme cold temperatures. The IceCure Family cryoablation
system is 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 as detailed below. The system is designed
to destroy tissue by the application of extreme cold temperatures
including prostate and kidney tissue, liver metastases, tumors,
skin lesions, and warts.
The system has the following specific indications:
Urology (ablate prostate tissue in cases of prostate cancer and
benign prostatic hyperplasia (BPH)).
Oncology (ablation of cancerous or malignant tissue and benign
tumors and palliative intervention).
Dermatology
• Ablation or freezing of skin cancers and other cutaneous
disorders.
• Palliation of tumors of the skin
• Destruction of warts or lesions
Gynecology (ablation of malignant neoplasia or benign dysplasia
of the female genitalia).
ENT (Palliation of tumors of the oral cavity and ablation of
leukoplakia of the mouth).
General Surgery
• Ablation of leukoplakia of mouth, angiomas, sebaceous
hyperplasia, basal cell tumors of the eyelid or canthus area,
ulcerated basal cell tumors, dermatofibromas, small
hemangiomas, mucocele cysts, multiple warts, plantar warts,
hemorrhoids, anal fissures, perianal condylomata, pilonidal cysts
actinic and seborrheic keratoses, cavernous hemangiomas,
recurrent cancerous lesions.
DSR7000000-REV G -IFU FOR CRYOPROBE – USA
• Palliation of tumors of the rectum, hemorrhoids, anal fissures,
pilonidal cysts, and recurrent cancerous lesions, ablation of breast
fibroadenomas)
• Destruction of warts or lesions.
• Palliation of tumors of the oral cavity, rectum, and skin.
• Ablation of breast fibroadenomas.
Thoracic Surgery (ablation of arrhythmic cardiac tissue and
cancerous lesions.
Proctology (ablation of benign or malignant growths of the anus
and rectum and hemorrhoids).
The system may be used with imaging device like ultrasound to
provide real-time visualization of the cryosurgical procedure.
Clinical decisions
The practitioner is solely
responsible for all clinical use of
the IceCure cryoablation system
and for any results obtained with
the device.
Figure 1: Single use cryoprobe label
A number of internationally
recognized symbols relating to
safety requirements and
standards are found on the
cryoprobe label. These symbols
are listed in the IceCure
cryoablation system User Manual.
Cryoprobes are not compatible with magnetic
resonance imaging
Cryoprobe Selection
Cryoprobes are fragile and can be damaged if mishandled.
Do not use a cryoprobe that has been bent, dropped, hit
against a hard surface or compromised in any manner, as
damage to the cryoprobe may have occurred.
The cryoprobe tip must be covered when not within the target
tissue.
Prior to starting a procedure, select a cryoprobe according to your
clinical
IceSense3®, IceCure®, IceSense® and ProSense® are Trademarks of IceCure Medical.
Ltd. In the United States and other countries. IceCure Medical Ltd. and other parties may
also have trademark rights in other terms used herein.
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judgment.