ZOLL CoolGard 3000, Руководство по эксплуатации

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Safety Information
8
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 System.
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
standard Start-up Kit assembly. Never use this device, or other method, to
circumvent the air trap alarm when the system 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 System.
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 INFLOW lumen of the catheter and
disconnect the outflow cap.
5. Infuse the 10 ml of saline – it should flow out the outflow lumen.
6. Cap the OUTFLOW 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 INFLOW 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 System.
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:
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