ZOLL Thermogard XP IVTM System Operation Manual - Manual (Page 8)

Safety Information
5
General Safety Precautions
WARNING! SYSTEMIC HYPOTHERMIA RISKS.
Systemic hypothermia may cause cardiac arrhythmia, patient shivering, or
other system or organ complications. Systemic hypothermia should only be
utilized under the supervision of a qualified physician.
When treating a patient with the System, appropriately qualified medical staff
must routinely and closely monitor the patient and must comply with the following
procedures:
 Audible and visual alarms generated by the System require the
authorized individual to remain in close proximity to the patient
throughout the procedure.
 Always verify the function of the System prior to insertion of an Alsius
catheter. In the event of a malfunction, have other means of cooling
available.
 When combining the use of the System and other adjunctive means
of cooling, ensure that close observation of the patient is maintained.
 Do not use the ZOLL System in conjunction with other temperature
maintenance devices that have an automatic temperature controller.
Temperature oscillations may occur that are dangerous to the
patient.
 Performance of installation, operation, or maintenance procedures
other than those described in this manual may create hazards and
may cause the manufacturer’s warranty to become void.
 Sterile components are designed for a single use only. If
unauthorized disposable components are used, proper operation
cannot be guaranteed and harm to the patient may result.
 Proper aseptic technique must be used while making all sterile
connections to the System.
 Never operate damaged or leaking equipment.
 Never operate the equipment without coolant fluid in the coolant well.
 Never use pure water, pure propylene glycol, or alcohol as a coolant
fluid.
 Never operate the equipment while smoking or in the presence of
open flame.
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