ZOLL IVTM, Operation Manual

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11
2. Introduction
Use of the System
WARNING. Patients must be continuously monitored. Patients being treated with the system must be
checked frequently (hourly) when the system is operating. It is possible for malfunctions or misuse of the sys-
tem to result in patient injury or death.
The ZOLL Intravascular Temperature Management (IVTM™) System is comprised of an external heat exchange
console (Thermogard XP
®
console) and an IVTM™ endovascular heat-exchange catheter connected via a ster-
ile heat exchanger and tubing circuit (Start-Up Kit). These components together comprise a patient tempera-
ture-regulation apparatus employing feedback control. The catheter and the Start-Up Kit are single-use
disposable devices.
This manual provides operating instructions for the console and the Start-Up Kit. Catheter components are ref-
erenced where it is necessary to ensure proper use with the system components. Always refer to the catheter’s
Instructions for Use for additional specific information.
Operating Life
The operating life of the catheters may vary according to design as indicated by the model designation. Always
refer to the catheter’s Instructions for Use for information about the catheter’s operating life.
The disposable components of the Start-Up Kit are designed for continuous use for a period not to exceed
seven (7) days on a single patient. After seven days of use, remove and replace the Start-Up Kit with a new
Start-Up Kit.
Caution. Start-Up Kit lifetime is seven days. The designed operating lifetime for Start-Up Kit components
is seven (7) days of continuous operation on a single patient. If a patient must be treated for a longer period, a
new Start-Up Kit must be installed in the console. Failure to adhere to this time limit may cause injury to the
patient.
Product designed for single use only. Do not resterilize or reuse. Do not alter the Start-Up Kit in any way.
Potential risks with re-use of a single use device include but are not limited to:
• Potentially life threatening infection
• Toxic shock due to degradation of materials
• Increased risk of thrombosis
• Reduced heat exchange power
• Device failures
Functional Description
The console can be described in terms of three major components: a recirculating chiller, a roller pump, and a
temperature control system. The system is connected to the temperature-controlled catheter by two small-
bore plastic tubes. One tube supplies temperature-controlled sterile saline solution to the catheter, and the
other tube returns the saline solution to the console. The sterile saline is pumped through a continuous recircu-
lating loop by a peristaltic pump inside the console. The saline solution acts as an intermediate heat-transfer
medium between the patient and the console. Sterile saline is used because it is biologically compatible with
the patient and in the unlikely event of a leak in the catheter, the possibility of harming the patient is reduced
to a practical minimum.