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DSR7000002-REV L-IFU FOR CRYOPROBE
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EUROPE
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.
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®)
ProSense® cryoablation system is intended for cryogenic
destruction of tissue during surgical procedures by the application
of extreme cold temperatures. The ProSense® cryoablation system
is indicated for use as a cryosurgical tool in the fields of general
surgery (including breast and liver tissue), dermatology, thoracic
surgery (including lung tissue), gynecology, oncology (including
Muskuloskeletal tissue), proctology, and urology (including kidney
tissue). The ProSense® cryoablation system may be used with an
ultrasound device to provide real-time visualization of the
cryosurgical procedure.
This cryotherapy should only be executed if the operative
standard therapy and established therapies cannot be applied.
Indications for Use
ProSense® cryoablation system is intended for cryogenic
destruction of tissue during surgical procedures by the application
of extreme cold temperatures. The ProSense® cryoablation system
is indicated for use as a cryosurgical tool in the fields of general
surgery (including breast and liver tissue), dermatology, thoracic
surgery (including lung tissue), gynecology, oncology (including
Muskuloskeletal tissue), proctology, and urology (including kidney
tissue). The ProSense® cryoablation system may be used with an
ultrasound device to provide real-time visualization of the
cryosurgical procedure.
Urology:
The system may be used to ablate prostatic tissue. The
system may be used to ablate kidney tissue including renal cell
carcinoma. The system may be used for the ablation of prostate
tissue in cases of prostate cancer and benign prostatic hyperplasia.
Oncology:
The system may be used for ablation of cancerous or
malignant tissue. The system may be used for ablation of benign
and malignant breast tumors. The system may be used for ablation
of benign and malignant lung tumors. The system may be used for
ablation of benign and malignant musculoskeletal tumors. The
system may be used for ablation of benign and malignant liver
tumors. The system may be used for ablation of benign tumors. The
system may be used for palliative intervention.
Dermatology:
The system may be used for the ablation or freezing
of skin cancers and other cutaneous disorders.
Gynecology:
The system may be used for the ablation of malignant
neoplasia or benign dysplasia of the female genitalia.
General Surgery:
The system may be used for the 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. The system
may be used for the destruction of warts or lesions. The system may
be used for the palliation of tumors of the oral cavity, rectum, and
skin. The system may be used for ablation of breast fibroadenomas
and breast tumors.
Thoracic Surgery:
The system may be used for the ablation of
arrhythmic cardiac tissue. The system may be used for the
ablation of cancerous lesions, including lung tissue.
Proctology:
The system may be used for the ablation of benign or
malignant growths of the anus and rectum. The system may be
used for the ablation of hemorrhoids.
This cryotherapy should only be executed if the operative standard
therapy and established therapies cannot be applied.
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 judgment.
Figure 3:
Cryoprobe selection
