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ZOLL IVTM™ System
Specific Operational Issues
WARNING! PATIENTS MUST BE CONTINUOUSLY
MONITORED.
Patients being treated with the IVTM System must be checked frequently (hourly)
when the IVTM System is operating. It is possible for malfunctions or misuse of
the IVTM System to result in patient injury or death.
ZOLL strives for the highest possible quality in its product–you expect that. Where
failure modes can be anticipated, we have designed the product so that, should it fail,
it will fail in a patient-safe manner.
Stop the Pump
The IVTM System is designed so that internal failure modes that pose a threat to the
patient will cause the system to stop the pump and sound an audible alarm. This is a
safe mode of operation because heat exchange will rapidly cease if there is no flow
through the catheter. If the pump is inactive, it is more difficult to make infusion
errors.
If the pump stops, check the display screen. You may have failed to hear or respond
to an audible alarm.
The pump will also stop under normal operating conditions:
Air Bubble Detector
In uncommon circumstances, it is possible for air to enter the tubing circuit of the
Start-Up Kit. In such cases, the integrity of the catheter prevents air entry into the
patient. In the rare event of a second, simultaneous failure of the catheter, air entry
into the patient is possible.
The IVTM System features an air bubble detector. This will cause three things to
occur if a significant amount of air enters the Start-Up Kit:
600248-001 Rev 3
1. Temperature inversion. The IVTM System will deactivate the pump
whenever one of the following states occurs to prevent unwated heat
transfer from/to the patient:
Coolant Temperature <Patient Temperature < Target Temperature
Coolant Temperature > Patient Temperature > Target Temperature.
Normal pump operation will recommence once the inversion has reverted.
2. The IVTM System 'self checks" its cooling engine each hour. To do this,
it stops the pump so that the heat load of the patient is removed from the
analysis.
3. The IVTM System is operating in "Fever Mode".
1. An audible alarm will sound.
2. The screen will display an appropriate error message:
"Air Trap Warning–Refer To Manual. Press Enter To Proceed."
3. The IVTM System will stop managing the patient's fever.
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Physicians' Manual
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