ZOLL Thermogard XP IVTM System Operation Manual - Manual (Page 10)

Safety Information
7
Primary Patient Temperature Probe (T1)
Failure
The System relies upon the patient temperature reading from a YSI-400 type
thermistor connected to the Primary Patient Temperature Probe (T1). There are
rare failures of this type of thermistor that cannot be detected by the System with
100% reliability. Failure of the T1 can result in either patient hypo- or hyper-
thermia. Death or serious injury to the patient may result. A secondary patient
temperature probe (T2) connection is therefore built into the system. For patient
safety, either use both the T1 and T2 connections or employ the T1 probe with
an independent frequent check of patient core temperature.
WARNING! NEVER CLINICALLY USE A RESISTOR IN PLACE
OF THE T1 TEMPERATURE PROBE
ZOLL supplies fixed value resistors and variable resistor test boxes (e.g the
TP-400 FOGG Box) for testing, training and demonstration purposes. These
can be plugged into the Primary Patient Temperature Probe T1 connection on
the front of the System to represent a patient. Never use this device, or other
method, to circumvent the normal patient temperature feedback control when
the system is connected to the patient. Doing so exposes the patient to the
hazards associated with hypo- or hyper- thermia. Death or serious injury may
result.
Configuration Changes
CAUTION! CONFIGURATION CHANGES MUST BE
CERTIFIED.
Equipment connected to the analog and digital interfaces must be certified to
the respective IEC standards (i.e., IEC 950 for data processing equipment
and IEC 60601-1 for medical equipment). Furthermore, all configurations shall
comply with the system standard IEC 60601-1. Any person who connects
additional equipment to the signal input part or the signal output part con-
figures a medical system and is therefore responsible that the system com-
plies with the requirements of the system standard IEC 60601-1.
Priming the Saline Circuit
WARNING! DO NOT PRIME THE SALINE CIRCUIT WHILE
CONNECTED TO A PATIENT
During the priming operation, the air-trap alarm will be disabled. Air present in
the saline line may be circulated through the indwelling catheter.
Before priming the circuit or during troubleshooting for possible leak,
disconnect the heat exchange catheter, then connect the inflow and outflow
luer fittings of the saline circuit together.
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