Contraindications - Integra CONTOUR-FLEX Mode D'emploi

Test procedure
1. Connect tubing to the manometer (if necessary).
2. Place one tube into water bath.
3. Align the manometer so the zero mark is level with fluid in the water bath.
4. Purge all air from system by flushing with syringe.
5. Attach the proximal connector of valve to be tested to the tube submerged in water bath.
6. Gently flush valve with sterile fluid and submerge completely in the water bath.
7. Fill manometer to approximately 30 cm H
8. While maintaining a gentle flow of fluid through valve using the syringe, isolate syringe from valve with the 3-way
stopcock.
9. The water column will begin to fall as fluid flows through valve. After 2 – 2.5 minutes, read fluid level in
manometer. The valve must be submerged in the water bath to obtain the correct results.
Pressure
5 ml/hr
flow rate
50 ml/hr
flow rate
Valve Markings

CONTRAINDICATIONS

Hydrocephalus shunt systems should not be implanted when the patient has known or suspected infections in the vicinity
of any of the implanted components (meningitis, ventriculitis, skin infections, bacteremia, septicemia, peritonitis, etc.).
Avoid implanting hydrocephalus shunt systems if infection is present anywhere in the body. Shunting into the atrium of
patients with congenital heart disease or other cardiopulmonary anomalies is contraindicated.
WARNINGS:
•
Patients with hydrocephalus shunt systems should be closely observed postoperative for signs and symptoms
of shunt obstruction or overdrainage of CSF.
•
Obstruction of the shunt system may lead to signs and symptoms of increased intracranial pressure. For an
infant, the signs may be increased tension on the fontanelle, congestion of scalp veins, listlessness,
drowsiness, nuchal rigidity, irritability, and vomiting. For older patients, the signs may be headaches,
vomiting, diminished consciousness, nuchal rigidity, and blurred vision.
•
Overdrainage by the shunt system may lead to signs and symptoms of reduced intracranial pressure and the
development of a subdural hematoma, subdural hygroma, or collapse of the lateral ventricular walls leading
to obstruction of the Ventricular Catheter.
•
Shunt obstruction or overdrainage requires immediate surgical intervention. The surgeon is advised to use
techniques to which he/she is accustomed.
•
The Ventricular Catheter may become bound to the choroid plexus or by fibrous tissue. Use gentle rotation
to free it. Forcible removal of the catheter may result in an intraventricular hemorrhage.
•
Placement of the distal catheter into the right atrium of the heart may lead to embolization of the
pulmonary arterial tree with resulting corpulmonale and pulmonary hypertension.
O.
2
Closing Pressure Results
Valve Pressure
(Regular and Small)
Low
Medium
High
Pressure/Flow Characteristics
Low
1 cm H2O
7 cm H2O
Acceptable
Closing Pressure
0.1 – 5 cm H O
2
5 – 11 cm H O
2
11 – 17 cm H O
2
Fig. 2
Medium
6 cm H2O
13 cm H2O
Fig. 3
5
English
High
12 cm H2O
20 cm H2O