Contraindications and Safety Information

Cryocare CS Surgical System


Contraindications

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

Safety Information

General Information

Unlike other cryosurgical systems that utilize Liquid Nitrogen with its inherent handling issues, the Cryocare Surgical System does not require set-up by factory service personnel. Also, the Cryocare system does not require special clothing or protective gloves during its use. The only portion of the system that reaches a freezing temperature is the tip of the CryoProbe.

Although the Cryocare Surgical System is simple to install and operate, the operator must exhibit care while handling the Argon and Helium gas cylinders and connecting/disconnecting the regulator and high-pressure hoses. All cylinders holding gas under pressure must be handled with care and must be kept secure at all times. Damaging the control valve, high-pressure hoses or regulator assembly by rough handling or dropping may result in damage and possible injury.

Warnings
  • Ultrasound monitoring must be used at all times during a prostate cryosurgical procedure. Do not begin a prostatic ablation procedure if transrectal ultrasound is not available. Discontinue treatment immediately if ultrasound image is not satisfactory. Refer to the ultrasound system operator's manual for specific instructions for use.

  • An Endocare Urethral Warming System and Catheter Kit must be used at all times during a urological cryosurgical procedure. If the Urethral Warming System is not working properly, discontinue treatment immediately.

  • The CryoProbe pre-test must be conducted prior to placing CryoProbes (see System Operation section). Discontinue treatment if the pre-test cannot be conducted successfully for any reason.

  • The Cryocare Surgical System produces extreme cold that results in a necrotic effect on tissue. Caution must always be exercised by the physician. The effects of cryosurgery on various types of tissues must be well understood.

  • Tissue perforation may occur if extreme cold is applied for excessive periods of time.

  • Screen tissues that are in close proximity to known arteries or veins to precisely locate these circulatory structures before beginning cryoablation.

  • Position the CryoProbe tip only in tissue intended for treatment

  • Discontinue treatment immediately if the patient develops any cardiopulmonary problems.

Precautions
  • Federal (USA) law restricts this device to sale by or on the order of a physician

  • The Cryocare Surgical System must only be used with the cryosurgical accessories stated in the manual. The system must only be connected to other devices that are approved to IEC 60601-1-1 (UL 60601-1) or IEC 950 (UL 1950) requirements.

  • There are no user serviceable parts with the Cryocare Surgical System. Refer all service issues to Endocare Customer Service at (888)236-3646.

  • Only qualified, trained personnel should operate the Cryocare Surgical System

  • Read the Cryocare Surgical System Operator's Manual and become thoroughly familiar with the system and controls before operation.

  • Exercise caution when treating patients who have had previous difficulty with surgical procedures.

  • All CryoProbes that are to be used in a procedure should be attached to the Cryocare console prior to turning on the Argon and Helium regulator valves.

  • Ensure all pressure and regulator lines are securely connected. Before removing supply lines from the control unit, all main gas cylinder valves must be turned off and excess pressure bled from the lines.

  • Do not use CryoProbes that are damaged in any way. Do not disconnect CryoProbes during operation while in the FREEZE or THAW modes. All CryoProbes must be in the OFF position prior to disconnection.

  • Be sure to follow standard guidelines for the safe handling and storage of high- pressure gas cylinders.

  • Closely monitor the Cryocare console display to verify correct operation of all functions.

  • The Cryocare system is classified by UL (Underwriters Laboratories) with respect to electric shock, fire, mechanical, and other specified hazards only in accordance with CAN/CSA [c22.2 No. 601.1 and UL60601-1].

Electromagnetic Compliance (EMC)
  • This equipment has been tested and found to comply with the limits for medical devices to the IEC 60601-1-2. These limits are designed to provide reasonable protection against harmful interference in a typical medical installation. It is important to install and use the equipment in accordance with the instructions, to prevent harmful interference to other devices in the vicinity. If this equipment does cause harmful interference to other devices, which can be determined by turning the equipment off and on, the user is encouraged to try to correct the interference by one or more of the following measures:

    • Re-orient or relocate the other device(s).
    • Increase the separation between the equipment.
    • Connect this equipment to an outlet on a circuit different from that to which the other device(s) are connected.
    • Consult the manufacturer or field service technician for help.