IceCure FAP 7100000 User manual

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DSR7000000-REV G -IFU FOR CRYOPROBE –USA
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®)
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.
•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 judgment.

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DSR7000000-REV G -IFU FOR CRYOPROBE –USA
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.
Figure 3: Cryoprobe selection
Figure 7: For illustration only Color Tag
labels for cryoprobe and the matching
introducer
The cryoprobe serial number (S/N) appears on the
screen/cryoprobe package/cryoprobe plastic grip.
Cryoprobe connection
Never reuse a single-use cryoprobe.
Connect the cryoprobe to the cryohandle, while maintaining
sterility of the cryoprobe:
1- Remove the plug that covers the cryoprobe connection point.
2- Insert the cryoprobe into the insertion point in the handle as
shown on the system screen and screw it until a “NEXT” button
appears on screen then confirm screwing by an additional slight
rotation to confirm that cryoprobe connection is secured.
3- Remove the cryoprobe tip protector.
When done, press “NEXT” on the
screen.
: Cryoprobe connection screen5ureFig
Cryoprobe operation
Perform a functional pre-test to ensure system efficacy and safety
as explained in the User Manual.
If a functional problem occurs or there is any unusual appearance
(such as frost on the plastic cover near the cryohandle, bubbles or
any unusual appearance), press "CANCEL" on the system screen
and follow system instructions until you are required to safely
remove the cryoprobe from the cryohandle. Before operating the
cryoablation system, make sure you have completed all pre-
operational stages.
You must NOT allow the freeze process to start before
the cryoprobe tip is actually within the target tissue.
Before activating the freeze cycle, insert the cryoprobe into the
target tissue under imaging guidance following the steps:
1. Confirm longest dimension of the target tissue
2. Plan the trajectory of the cryoprobe prior to placement.
When clinically safe, the center of the cool zone shall be along
the longest dimension of the target tissue.
3. The black safety mark should be completely in the tissue.
4. In percutaneous approach, perform a 3 mm skin incision (for
example using #11 blade) before the cryoprobe is inserted.
5. Position the tip of the cryoprobe at the distal end of the long
axis of the target tissue, when clinically safe
6. Center of the cool zone, should be in the center of the tissue
to be ablated (see figure 2 for the distance of the cool zone
from the tip of the cryoprobe that is visible under Ultrasound
or CT imaging)
7. Maintain sterility and patient safety.
Be aware of the markings on the cryoprobe: the wide black mark
closest to the tip is the safety mark. In percutaneous procedures it
must be completely inside the tissue to avoid skin burns. The rest
of the marks indicate depth of cryoprobe insertion: each mark
equals one centimeter with distinctive markings at 5 and 10 cm (50
& 100 mm).
Figure 6: illustration of FAP7200000 cryoprobe markings on the cryoprobe
Once you have verified the cryoprobe is located in its right place,
you may begin freezing.
Portions of the cryoprobe other than the freeze zone,
including the plastic cover that is located near the
cryoprobe handle, may become cold and cause tissue
damage. If unwanted freezing occurs, immediately stop the
freezing process. In case of frost on shaft, start Extraction if
possible. If not, wait for passive Thaw. In both cases, use skin
protection techniques.
To prevent injury, cryoprobes must be closely observed during use
for signs of unwanted freezing.
During Thaw, the ice ball melts partially or totally depending on the
thaw time and the tissue properties.
Keep the cryoprobe location steady in the target tissue during all
of the thaw period. Control the process under Ultrasound or CT
imaging system.
The Extraction step occurs at the end of every treatment. Its
purpose is to allow the cryoprobe’s removal from the target tissue
in the fastest and safest way.
At the end of the extraction step, a message will be displayed on
system screen. Wait for the message, then gently remove the
cryoprobe from the target tissue.
Do not force removal of the cryoprobe from the tissue as it might
increase the risk of hematoma.
If the cryoprobe cannot easily be extracted from the tissue, press
the “Extraction” icon on screen to initiate another Extraction cycle.
In case the Extraction process isn’t available, wait for passive Thaw.
Before removing the cryoprobe from the tissue, make
sure the freeze effect has been deactivated and the
cryoprobe can be easily withdrawn. Never use excessive force to
extract the cryoprobe.
Cryoprobe disassembling
After removing the cryoprobe from the target tissue, and only if
system screen displays a message that it is safe to disengage the
cryoprobe, detach the cryoprobe from the cryohandle as follows:
1. Unscrew the used cryoprobe from the cryohandle and
dispose of it appropriately.
2. Remove the single-use sterile cover from the cryohandle.
3. Close the cryohandle with the covering plug.
Following each cryosurgical procedure, discard the single use
devices (single-use cryoprobe, single-use introducer, single-use
Figure 4: The cryoprobe

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DSR7000000-REV G -IFU FOR CRYOPROBE –USA
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.
temperature sensor, cryohandle, flexible hose and touch screen
covers and sleeves).
All single use devices are considered medical waste and must be
disposed off in accordance with medical waste laws and hospital
standards. Sharp objects such as the cryoprobe and temperature
sensor must be disposed of in a sharps container.
The cryoprobes are single use and are suppliedin single
use packaging. Never reuse a single-use cryoprobe.
Reprocessing single use device (like the cryoprobe, introducer and
temperature sensor) could affect the mechanical or performance
or microbiological properties of the product.
Contraindications
There are no known contraindications specific to the use of
IceCure’s cryoablation systems and its’ Cryoprobes.
Potential Adverse Events
Frostbite are known adverse events related to the specific use of
the Cryoablation cryoprobes. There are, however, potential
adverse events associated with any surgical procedure. Potential
adverse events which may be associated with the use of
cryoablation may be organ specific or general and may include, but
are not limited to myocardial infraction, 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,
disseminated intravascular coagulation (DIC), deep vein thrombosis
(DVT), ecchymosis, edema/swelling, ejaculatory dysfunction,
erectile dysfunction (organic impotence), fever, fistula, hematoma,
hematuria, hypertension, hypotension, hypothermia, idiosyncratic
reaction, ileus, impotence, infection and thermal injury to the skin,
injection site reaction, myocardial infarction, nausea, neuropathy,
obstruction, organ failure, pain, pelvic pain, pelvic vein thrombosis,
penile tingling/numbness, perirenal fluid collection, mild vaginal
staining, pneumonia, empyema, hemoptysis, lung collapse,
thrombosis (evolved risk for patient with an existing AV fistula),
phrenic nerve palsy, cough, back pain, skin injury, pulmonary
emboli, Loss of speech (temporary aphasia from recurrent
laryngeal nerve damage, arm paresis, burn, hemorrhage,
pneumonitis, Respiratory failure/arrest, Hemothorax, pneumonia,
empyema, lung collapse, thrombosis (evolved Risk for pt. with an
existing AV fistula), phrenic nerve palsy, subcutaneous
emphysema, death due to Acute respiratory distress syndrome,
pulmonary emboli, tumor recurrence, hemorrhage, dyspnea,
hematoma pleural effusion, pneumothorax, cryoprobe site
paresthesia, prolonged chest tube drainage, prolonged intubation,
pulmonary embolism, pulmonary insufficiency / failure, rectal pain,
renal fracture, renal infract, genitourinary perforation, glomerular
filtration rate elevation, transfusion, infection lumbar
radiculopathy, transfusion, acute bowel injury, colorenal fistula,
exuberant local disease, infection lumbar radiculopathy,
myocardial infraction, transfusion, acute bowel injury, colorenal
fistula, exuberant local disease, 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, 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 and wound complication. muscular injury, pain, swelling,
Osteonecrosis, osteomyelitis, Chondrolysis (rapid and sudden
damage to the cartilage results in arthritis), damage to
Osteocartilage structure, Nerve Palsy, Motor Dysfunction, Peri-
ablational neuropathies, swelling up to compartment syndrome,
bowel damage, urinary tract damage, pericardial effusion in (in
chest wall ablations), avascular necrosis of femur head, ureteral
stricture, tumor recurrence.
Cryoprobe technical specifications
The packed cryoprobes shall be stored in a dry, cool, well-ventilated
and clean environment without corrosive gas.
In general, IceCure's Cryoprobes are available in various diameters
(2.4mmto 3.4mm), variousice ball shapes (Spheric, Ellipsoid), various
tips (trocarand pencil) and various lengths (127mm to 185mm
external shaft length) according to the expected application, treated
tumor size and surgery approach.
The opening of the cryoprobe pouch should be
where the “PEEL HERE” label is positioned.
Figure 6: “Peel Here” label
Ref number: FAP 7100000, FAP 7200000, FAP 7400000,
FAP 7410000, FAP 7600000 and FAP 7800000.
Range temperature: -196C to +40C
Needle diameter: 2.4mm (13G) or 3.4mm (10G)
Certain configurations are not available in some regions.
IceCure Medical, Inc.
41-18 Christine Ct
Fair Lawn, NJ, 07410, USA
[e-mail]
Tel: [phone]
IceCure Medical Ltd.
7 Haeshel St., 2nd floor,
Caesarea 3079504, Israel
[e-mail]
Tel: [phone]; Fax: [phone]