ZOLL Thermogard XP IVTM System Operation Manual - Manual (Page 15)

Introduction
3
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
System to result in patient injury or death.
The ZOLL Thermal Regulating System is comprised of an external heat
exchange system (CoolGard 3000 or Thermogard) and an Alsius endovascular
heat-exchange catheter connected via a sterile heat exchanger and tubing circuit
(the Alsius Start-up Kit). These components together comprise a patient
temperature-regulation apparatus employing feedback control. The catheter and
the Start-up Kit (its heat exchange coil, air trap, and tubing) are single-use
disposable devices.
This manual provides operating instructions for the System and the start-up kit.
Catheter components are referenced where it is necessary to assure 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 Alsius start-up kit are designed for continuous
use for a period not to exceed seven (7) days. After seven days of use, all start-
up kit components must be removed and replaced with components from a new
start-up kit.
CAUTION! START-UP KIT LIFETIME IS SEVEN (7) DAYS.
The designed operating lifetime for start-up kit components is seven (7) days
of continuous operation. If a patient must be treated for a longer period, a new
start-up kit must be installed in the System. Failure to adhere to this time limit
may cause injury to the patient.
Functional Description
The System can be described in terms of three major components: a
recirculating chiller, a sterile fluid 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
System. The sterile saline is pumped through a continuous recirculating loop by a
peristaltic pump inside the console. The saline solution acts as an intermediate
heat-transfer medium between the patient and the System. 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.
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