THERMAL SENSOR Instructions for Use Oct 2013

Table of Contents 1 Product Description... 1 1.1 Intended Use... 1 1.2 Technical Description... 1 1.3 Galil Medical TS/MTS... 3 1.4 Product Specifications... 4 2 How Supplied... 4 3 Indications for Use... 4 4 Contraindications... 4 5 Warnings... 5 6 Precautions... 6 6.1 General... 6 6.2 Handling and Sterilization... 6 6.3 During Use... 7 6.4 After Use... 7 7 Potential Adverse Events... 8 8 Directions for Use... 8 8.1 TS/MTS Preparation... 8 8.2 TS/MTS Use... 9 8.3 TS/MTS Removal... 9 9 DISCLAIMER OF WARRANTY... 10

Single-Point 1.5 Thermal Sensor™ and Multi-Point 1.5 Thermal Sensor™

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1 Product Description 1.1 Intended Use The Galil Medical disposable Single-Point 1.5 Thermal Sensor™ and Multi-Point 1.5 Thermal Sensor™ devices are components used in conjunction with a Galil Medical Cryoablation System when performing cryoablative destruction of tissue, to aid the physician’s assessment that the Freezing/Thawing cycles meet the desired treatment protocol. NOTE: These instructions are applicable to both the Single-Point 1.5 Thermal Sensor (TS) and the Multi-Point 1.5 Thermal Sensor (MTS). Collectively, these sensors are referred to as TS/MTS. It is recommended that TS and/or MTS be inserted into strategic locations in the tissue prior to the procedure so the acquired temperature readings will provide useful information about the progress of the Freezing and Thawing processes. These realtime temperature readings can be used to monitor the temperature of the tissue being ablated and to monitor the temperature of tissue not intended to be ablated.

1.2 Technical Description Each TS/MTS has a sharp cutting tip, a shaft with circumferential marks, a color-coded handle, tubing, and an electrical connector. The shaft marks on the TS/MTS are shown in Fig 1, below. All components are illustrated in Fig 2.

150 mm

3

4

5

175 mm

100 mm

2

50 mm

20 mm

1

5

#

Shaft Marks

Description

1

Thick Marks

Start 20 mm from tip, in 10 mm intervals

2

Thin Marks

Start 25 mm from tip, in 5 mm intervals

3

Single-thick Mark

Located 50 mm from tip

4

Double-thick Mark

Located 100 mm from tip

5

Triple-thick Mark

Located 150 mm from tip Fig 1. TS/MTS Shaft Marks

Single-Point 1.5 Thermal Sensor™ and Multi-Point 1.5 Thermal Sensor™

1

2

1

3

4

5

Multi-Point TS

MTS Straight

1

3

2

4

5

Thermal Sensor

TS Straight

1

2

Thermal Sensor

TS Angled

3

4 1

Cutting tip

2

Shaft (length 175 mm; diameter 1.5 mm)

3

Handle

4

Tubing (length ~ 2.5 m)

5

Electrical connector

5

Fig 2. TS/MTS Components

2

Instructions for Use

Sensor locations on the TS/MTS are specific to the sensor brand: • TS 5 mm from the tip (see Fig 3) • MTS

5, 15, 25, and 35 mm from the tip (see Fig 4)

5 mm x

Thermal Sensor

5 mm

15 mm

25 mm

35 mm

Fig 3. TS Sensor Location

x

x

x

x

Multi-Point TS

Fig 4. MTS Sensor Locations NOTE: Temperature accuracy is ± 5oC. TS and MTS have different connectors and can be connected only to Galil Medical Cryoablation System ports specific to a TS or MTS.

1.3 Galil Medical TS/MTS Sensor Brand Name

Configuration

REF

Handle Color

Single-Point 1.5 Thermal Sensor™

Straight

FPRPR3212

White

Single-Point 1.5 Thermal Sensor™

Angled 90o

FPRPR3206

White

Multi-Point 1.5 Thermal Sensor™

Straight

FPRPR4010

Grey

NOTE: TS are available for use with a Galil Medical SeedNet® Cryoablation System. NOTE: MTS are available for use with a Galil Medical Visual-ICE® Cryoablation System or with a Galil Medical Presice® Cryoablation System.

Single-Point 1.5 Thermal Sensor™ and Multi-Point 1.5 Thermal Sensor™

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1.4 Product Specifications Materials

Sensor Shaft

Stainless steel

Sensor Handle

Brass (coated shaft with heat shrink tubing)

Tubing

Polyurethane

Electrical Connector TS:

body - Nylon contacts - Copper Constantan MTS: body - Polysulfone contacts - Gold Plated

Sterilization Method Ethylene Oxide (EO)

2 How Supplied Each TS/MTS is packaged in a sealed film-Tyvek® pouch. Each pouch is labeled Sterile, for SINGLE USE only. NOTE: The Galil Medical Cryoablation System is supplied separately. • Storage Store in a cool, dry place. • Use By Refer to expiration date marked on the external packaging.

3 Indications for Use Galil Medical Thermal Sensors are intended for use as ancillary products when performing cryoablative destruction of tissue during surgical procedures. TS/MTS products, used with a Galil Medical Cryoablation System, 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. Galil Medical Cryoablation Systems are designed to destroy tissue (including prostate and kidney tissue, liver metastases, tumors and skin lesions) by the application of extremely cold temperatures. A full list of specific indications can be found in the respective Galil Medical Cryoablation System User Manual.

4 Contraindications There are no known contraindications specific to use of the Galil Medical TS/MTS.

4

Instructions for Use

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 cryotherapy is necessary before using this product. Use of this device should be restricted to use by or under the supervision of physicians trained in cryotherapy procedures with a Galil Medical Cryoablation System. • Do not use TS/MTS near magnetic resonance imaging (MRI) equipment. • The Galil Medical Thermal Sensor (TS/MTS) is a disposable product and is designed as a single-use product. This device has not been validated for resterilization or reprocessing. Potential anticipated risks associated with reprocessing of this product include, but are not limited to, inadequate sterilization thereby creating an increased risk of patient infections and increased risk of bloodborne pathogen disease transmission; degradation of performance due to material fatigue and loss of thermal sensor function, thereby creating increased patient risks, including but not limited to the risk of inadequate or excessive patient treatment. • Whenever operating a Galil Medical Cryoablation System, a TS or MTS should be used to monitor tissue temperatures during Freezing and Thawing cycles, comparing procedure temperatures to the intended treatment protocol. • BEFORE THE PATIENT IS ANESTHETIZED, Needle Integrity and Functionality Tests on each cryoablation needle and Thermal Sensor Integrity and Functionality Tests on each thermal sensor must be completed successfully. • A defective TS/MTS must never be used and should be returned to Galil Medical for investigation and replacement. • In the rare event that a thermal sensor breaks while inserted in the tissue, act immediately to remove sensor parts from the patient’s body and report such event to Galil Medical. • Discontinue all needle operation prior to needle and thermal sensor removal to minimize risk of tissue injury. • Remove thermal sensors from the patient prior to disconnecting the thermal sensors from the cryoablation system.

Single-Point 1.5 Thermal Sensor™ and Multi-Point 1.5 Thermal Sensor™

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6 Precautions 6.1 General • The physician is solely responsible for all clinical use of the cryoablation needles and thermal sensors and for any results obtained by use of the system. All clinical decisions prior to and throughout the cryotherapy procedure shall be made by the physician based upon his/her professional opinion. • Training on appropriate use of a Galil Medical Cryoablation System is required prior to conducting cryotherapy with a Galil Medical System. • Continuously monitor the cryotherapy procedure using direct visualization or image guidance such as ultrasound or Computed Tomography (CT). • Use TS/MTS to monitor attainment of the freeze / thaw temperatures for the intended treatment protocol. • Use TS/MTS to monitor temperature in target tissue near critical structures. • Availability of back-up TS/MTS is recommended should a replacement or additional TS/MTS be required during a procedure. • Do not use TS/MTS near magnetic resonance imaging (MRI) equipment. • Ensure appropriate stability of tubing to avoid inadvertent snagging of tubing and/or TS/MTS shifting during a procedure. • Use care in handling TS/MTS packages during transport and storage. • Avoid extremes in temperature and humidity during transport and storage.

6.2 Handling and Sterilization • Observe the expiration date of this product. Do not use past the listed expiration date. • Before opening a sensor pouch, check the sterilization indicator within the pouch. • Each thermal sensor is provided for one-time use only. The sensor has not been tested for multiple use. Do not resterilize a thermal sensor. • Inspect the packaging for damage. Do not use a TS/MTS if packaging appears opened or damaged, or the sensor is damaged; in the event of such occurrence, contact a Galil Medical representative to arrange return of the complete package with the product. • Open the outer pouch carefully; aseptically remove each inner pouch and transfer to the sterile area. • Before use, always inspect the TS/MTS for damage, bending or kinking. A bent or damaged TS/MTS must never be used. • Do not bend a TS/MTS. • For proper insertion of an MTS into a connection port, ensure that the rectangular tongue on the MTS connector is aligned with the groove at the top of the connection port. 6

Instructions for Use

• Before use, always perform the Thermal Sensor Integrity and Functionality Test. Do not use a TS/MTS that has failed to pass the Thermal Sensor Integrity and Functionality Test. • TS/MTS needles have sharp tips. Use care to ensure safe handling of TS/MTS to eliminate the risk of injury or possible exposure to blood-borne pathogens.

6.3 During Use • Always ensure use of thermal sensors in a strictly sterile environment. • Ensure all connections between the cryoablation system and the TS/MTS are tight. • Use image guidance to monitor TS/MTS insertion, positioning and removal. • Do not kink, pinch, cut or pull excessively on TS/MTS tubing. Damage to handle or tubing may cause the TS/MTS to become inoperable. • During use, avoid damage to the TS/MTS from handling or inappropriate contact with surgical instruments. • Avoid bending the TS/MTS shaft. Do not grasp the TS/MTS with auxiliary instruments as this may cause damage to the sensor shaft. • During a cryotherapy procedure, do not immerse the proximal handle or tubing in fluids. • Ensure adequate thawing before attempting to remove a TS/MTS. • Do not expose a TS/MTS to organic solvents such as alcohol which may damage the thermal sensor.

6.4 After Use • After disconnecting thermal sensors from the cryoablation system, use strong scissors to cut each sensor at the point where the tubing meets the handle. • TS/MTS have sharp tips. Use care to ensure safe disposal of thermal sensors. To eliminate the risk of injury or possible exposure to blood-borne pathogens, dispose of used thermal sensors in a biohazard container in accordance with hospital and safety regulations.

Single-Point 1.5 Thermal Sensor™ and Multi-Point 1.5 Thermal Sensor™

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7 Potential Adverse Events There are no known adverse events related to the specific use of the Galil Medical TS/MTS. 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, death, delayed/non healing, deep vein thrombosis (DVT), diarrhea, disseminated intravascular coagulation (DIC), ecchymosis, edema/ swelling, ejaculatory dysfunction, erectile dysfunction (organic impotence), fever, fistula, genitourinary perforation, glomerular filtration rate elevation, hematoma, hematuria, hypertension, hypotension, hypothermia, idiosyncratic reaction, ileus, impotence, infection, injection site reaction, myocardial infarction, nausea, neuropathy, obstruction, organ failure, pain, pelvic pain, pelvic vein thrombosis, penile tingling/numbness, 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 NOTE: For information regarding software-control of thermal sensor performance, refer to the appropriate cryoablation system User Manual.

8.1 TS/MTS Preparation 1. Using aseptic technique, carefully remove the TS/MTS from the package and place in a sterile work area. 2. Connect the TS/MTS to the appropriate port on the cryoablation system - see note below. NOTE: When connecting an MTS to the needle connection panel, ensure that the rectangular tongue on the MTS connector is aligned with the groove at the top of the connection port. The TS/MTS is now ready for the Thermal Sensor Integrity and Functionality Test. NOTE: For detailed instructions on connecting a TS/MTS to the cryoablation system and performing the Thermal Sensor Integrity and Functionality Test, refer to the appropriate cryoablation system User Manual. 8

Instructions for Use

8.2 TS/MTS Use 8.2.1

TS/MTS Handling and Insertion

• Correct insertion of thermal sensors into the target tissue is the responsibility of the physician. NOTE: Although TS/MTS have sharp tips, a small skin incision may be made at the point of TS/MTS insertion. • Always use two hands and support the TS/MTS mid-shaft with two fingers to eliminate the risk of bending. Do not insert the sensor into tissue while holding the handle with one hand only. • Insertion depth may be estimated using the marks on the shaft. Use image guidance as necessary to guide TS/MTS insertion and placement. • Use image guidance to verify that the TS/MTS is placed at the desired location prior to activating the cryoablation needles.

8.2.2

Notes for Monitoring Temperatures

• Select the TS/MTS sensor locations appropriate to monitor the target tissue temperature numerically and/or graphically during the cryoablation procedure. • Use data from the TS/MTS display to assess tissue temperatures in the tissue surrounding a TS/MTS. • See the respective User Manual for instructions on system controls available to manage TS/MTS displays.

8.3 TS/MTS Removal • Thaw thoroughly and stop all needle operation prior to removing a TS/MTS to minimize a risk of tissue injury. NOTE: Ensure the tissue temperature is above 0°C before removing the TS/MTS. It is preferable to remove the TS/MTS before the cryoablation needles, to allow further thawing should additional thawing be required. NOTE: Galil Medical's thermal sensors are specially designed with a three-facet, trocarlike tip to minimize bleeding. However, some bleeding may occur. In the event of bleeding, apply treatment in accordance with good clinical practice and the hospital's treatment protocol. For example, following TS/MTS removal, hold compression until hemostasis is achieved; if necessary place appropriate dressing on the insertion site.

Single-Point 1.5 Thermal Sensor™ and Multi-Point 1.5 Thermal Sensor™

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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.

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Instructions for Use

Single-Point 1.5 Thermal Sensor™ MultiPack

-

REF FPRPR3212

Single-Point 1.5 90o Thermal Sensor™ MultiPack

-

REF FPRPR3206

Multi-Point 1.5 Thermal Sensor™

-

REF FPRPR4010

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 (Israel) Ltd., Industrial Park, Tavor Building 1, Yokneam 2069203, 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

Copyright© 2013 Galil Medical LGC13-TSS055en-01 October 2013