For healthcare professionals

Resources.

Labeling, ordering, and how to report a product issue.

Labeling

Instructions for Use and manuals.

Current labeling ships with every device. Request an electronic copy and we will send the current revision.

Directional Cryoprobe
Instructions for Use
Device description, isotherm data, indications, warnings, precautions, and directions for use for the Directional Cryoprobe.
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Console
Operator’s Manual
Setup, argon connection, system operation, alarms, troubleshooting, specifications, and maintenance for the console.
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System
Quick Start Guide
A condensed reference for setup and the Cryoprobe Test.
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Ordering

Products.

Directional Cryoprobe

20 cm long, 2.1 mm diameter, circumferential and directional. Sterile, single use, one per package.

Focused Cryotherapy System console

Runs up to four probes at a time. Ships in a transport case with the argon supply line, regulator, and power cord.

Orders and customer serviceorders@focusedcryo.com · (404) 594-4280

Coding and payment questionsContact us

Product safety

Report a product issue.

To report a complaint, malfunction, or adverse event involving the Focused Cryotherapy System or Directional Cryoprobe, contact Focused Cryo support:

support@focusedcryo.com · (404) 594-4280

Include the product, lot number, date of the event, and a description. Do not include patient-identifying information in email. Retain the device and packaging if possible.

See the system in person.

Request a demonstration, labeling, or a conversation with our team.

Request a demonstration Contact us

Important Safety Information

Indications for use

The Focused Cryotherapy System is intended for cryoablative destruction of tissue during surgical procedures. The Focused Cryotherapy System is indicated for use as a cryosurgical tool in the fields of general surgery, dermatology, neurology (including cryoanalgesia), thoracic surgery (with the exception of cardiac tissue), ENT, gynecology, oncology, proctology, and urology. See full indications.

Contraindications

There are no specific contraindications for the use of this device.

Warnings

The cryosurgical systems produce extreme cold which results in a necrotic effect on tissue. Visualization must be used at all times during a cryosurgical procedure. If at any point visualization stops or becomes impaired, discontinue treatment immediately. Verify the direction and orientation of the Directional Cryoprobe’s directional isotherm prior to beginning treatment. Position the Directional Cryoprobe’s ablation zone only in tissue intended for treatment. The Focused Cryotherapy System is not safe for use in the MR Environment.

Caution: Federal (USA) law restricts this device to sale by or on the order of a physician. Refer to the Instructions for Use and Operator’s Manual for complete indications, warnings, precautions, and potential complications. Full Important Safety Information.