9
ment to the signal input part or the signal output part configures a medical system and is therefore responsible
that the system complies 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 cath-
eter. Before priming the circuit or during troubleshooting for possible leak, disconnect the heat exchange cath-
eter, then connect the IN and OUT Luers of the saline circuit together.
Air Entry Into the Tubing Circuit
Air entry may occur with the failure of any part of the Start-Up Kit, between the saline bag and the outflow of
the pump. 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.
Air entry into the tubing circuit will usually, but not always, be associated with an air trap alarm that will stop
the console.
Always investigate air trap alarms
. The cooling circuit is a closed loop–usually air trap alarms
indicate a breach somewhere in this closed loop (occasionally an air trap alarm can be caused by condensation
forming on the air trap exterior). With any air trap alarm, check both the integrity of the catheter and the
Start-Up Kit (see below).
Periodically check the Start-Up Kit for significant air bubbles and replace the kit if necessary.
WARNING. Never clinically circumvent the air trap alarm.
ZOLL supplies air trap “dummies” for testing,
training and demonstration purposes. These are fluid filled air trap assemblies that are separate from a stan-
dard Start-Up Kit assembly. Never use this device, or other method, to circumvent the air trap alarm when the
console is connected to the patient. Doing so exposes the patient to the hazards associated with air embolism
should the catheter fail. Death or serious injury may result.
Check the Integrity of the Catheter
To check the integrity of the catheter, perform these steps in the indicated order:
1. Stop the console.
2. Using aseptic technique, disconnect the tubing from the catheter and properly cap both the catheter and
the tubing set.
3. Fill a sterile 10 ml syringe with sterile saline.
4. Connect the syringe to the IN lumen of the catheter and disconnect the OUT cap.
5. Infuse the 10 ml of saline – it should flow out the OUT lumen.
6. Cap the OUT lumen and pull and hold 5 ml of vacuum for at least 10 seconds. Approximately 4 ml of
saline, but not blood, should enter the syringe and you should be able to maintain the vacuum.
7. Ease the vacuum, disconnect the syringe, and recap the IN lumen.
Check the Integrity of the Start-Up Kit Tubing
To check the integrity of the Start-Up Kit tubing, perform these steps in the indicated order:
1. Stop the console.
2. Look for obvious leakage.
3. Remove the tubing from the pump and check it for damage. Replace it in the pump if it is undamaged.
4. Inspect the tubing from the pump to the patient for sources of fluid loss:
•
Look for damage to the tubing and/or the presence of air inside the tubing.
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