DEVICE DESCRIPTION
The PHOENIX CRx Universal Shunt consists of one silicone elastomer Cruciform 1m slit valve positioned in a Polysulfone housing, which is enclosed in a cylindrical silicone pumping chamber attached to a ventricular catheter with a separate 90 cm, open end distal catheter. A lot number is stamped on the polysulfone housing. The silicone valve mechanism inside the polusulfone valve housing is thimble-shaped with a cross-shaped (cruciform) slit in its distal end. The mid-portion of the cylindrical silicone body serves as a pumping chamber. There is an integral polysulfone connector at the Inlet of the valve housing to facilitate connection of the ventricular catheter. A radiopaque pressure designation code of one, two or three radiopaque dots, indicating low, medium, or high pressure, appears on the connector tube over the pumping chamber.

The pumping Chamber of the shunt assembly is 5.0 mm high x 21 mm long. The outlet adapter has an outer diameter of 2.3 mm and an inner diameter of 1.3 mm. A ventricular catheter is bonded to the pumping chamber. There is an attached ventricular catheter of either 6 cm or 8 cm having an ID of 0.9 mm and an OD of 2.5 mm. A metal introducer stylet is included. Included is a separate 90 cm open-end distal catheter with an outer diameter of 2.5 mm and an inner diameter of 1.2 mm. The Phoenix CRx Universal Shunt .IS double-packaged, and IS STERILE AND NON-PYROGENIC unless the Inner pouch IS opened or damaged.

INDICATIONS
This device is intented for use as the principle pressure-regulating component of a cerebrospinal fluid shunt assembly, used un the treatment of hydrocephalus.

CONTRAINDICATIONS
This device is not intended for any use other than that indicated.
Ventriculo-atrial shunting is contraindicated in patients with infection, high risk of infection, pulmonary emboli, or high atrial pressure associated with congenital heart failure.
Ventriculo-peritoneal shunting is contraindicated in patients wit peritonitis, infection, high risk of infection, or a history of the same.

PRECAUTIONS
Aseptic technique is necessary in all phases of the use of this device.
It is imperative that this device not be handled with bare fingers or come into contact with lint. Silicone elastomer is highly electrostatic and therefore susceptible to contamination by airborne or surface particles, thus minimize exposure of silicone to air. The presence of these contaminants could cause adverse tissue reaction. Rubber-shod clamps or washed, gloved hands are the best means of handling implantable, silicone devises.
Carefully ligate all connections securely using non-absorbable, non-metallic 00 sutures. Do not tie ligatures too tightly or use stainless steel ligatures since silicone elastomer is easily cut.
Ensure flow of CSF from the distal end of the shunt system prior to closure.
This device is intended for SINGLE USE ONLY.
Federal Law (USA) restricts this device to sale by or on the order of a physician.

IMPLANTATION
The following procedure is offered as an aid to the surgeon and is not intended to replace individual clinical judgment. Soaking CSF shunt components in an antibiotic solution has been cited as a valuable element of protocols designed to reduce shunt infections. A right parieto-occipital approach is described here, although placement of the scalp incision may vary with the surgeon's preference and other factors.
1. After induction of general anesthesia, the head is turned to the left so that the right posterior parietal scalp is accessible. The scalp, neck and, in cases where the peritoneal catheter is used, the chest and abdomen are shaved, washed and then cleaned with an iodine solution. A continuous field is draped which includes the right posterior parietal portion of the scalp, the right side of the neck, and when necessary, the middle third of the anterior chest and upper abdomen. The exposed skin is covered with an adherent plastic sheet. A curved incision is planned so that its base is anterior and slightly inferior. The scalp flap is planned so that a burr hole, centered on a point approximately 3 cm from the midline and 7 to 9 cm superior to the external occipital protruberance, will lie under the middle of the flap. Desirable placement of the valve is under an area of thick, well nourished scalp, in a position adjacent to, not directly under, the incision.
2. After the burr hole is made and the ventricular component inserted.

NOTE: If a VA shunt is being implanled take care to insure against air embolism.

3. CSF flow must be verified following each connection, and before
closure.
4. The wound is thoroughly irrigated with antibiotic solution and during the operation the exposed tissues and shunt components are covered with lint-free surgical sponges soaked in the same solution.
5. The valve may be sutured to the pericranium to avoid migrations of the silicone body with a loop of suture around the inlet adapter. The wound is closed in two layers; the galea with a row of interrupted 000 sutures, and the skin with a fine monofiliament suture.
6. It is the practice of some physicians to use prophylactic antibiotics starting the day before operation, for the next three successive days, and to inject the antibiotic into the ventricle component whenever the ventricular component is exposed or changed.

THEORY OF OPERATION
The Cruciform progressive resistance,. Differential pressure valve mechanism, utilized in the Universal Shunt, was designed by John Holter D.Sc. to control intracranial pressure (ICP) and reduce overdrainage when shunting cerebrospinal (CSF) from the ventricles of the brain to the right (Figure 1)

These curves describe the inlet fluid pressure necessary to drive fluid, influenced by a pulse, through the valve at corresponding flow rates. They reflect in vitro test results and not the intracranial pressure of the patient after implantation. The nominal pressure represents operating pressure at the 2Occ/hr flow rate. The nominal pressure specifications at other flow rates are found by following the horizontal lines to the left side pressure scale. The performance of the valve is such that flow rate increases gradually with increasing differential fluid pressure and, conversely, decreases gradually with decreasing differential fluid pressure. (Figure 1)

WARNINGS
Tumor dissemination. inadequate drainage and over drainage of cerebrospinal fluid, infection, disconnection, skin erosion, and bacterial colonization of the valve have been reported as complications of shunting in general and may be assumed to be potential complications of the use of Phoenix valves and shunt systems.
Cardiopulmonary complications such as pulmonary embolism, cardiactamponade and atrial perforation, have been reported In the use of ventriculo-atrial (VA) shunts.

STERILIZATION
The product has been sterilized with 100% ethylene-oxide gas. If the inner package seal is broken or the package has been opened or is damaged, sterility may be compromised. In this case do not use the product.

RE-STERILIZA TION
THIS PRODUCT IS RECOMMENDED FOR SINGLE USE ONLY.

PRE-IMPLANT VALVE PREPARATION:
NOTE: For optimal results, it is recommended by PBC that the procedures, outlined below, be followed prior to implantation. Failure to do so may result in substandard valve performance

1. Fill a sterile bowl with sterile physiologic solution.
2. Using aseptic technique, remove the shunt from the package.
3. Remove the inserts from the distal slits.
4. Fill the catheter with sterile saline using a syringe.
5. Ensure that all air has been removed from the lumen, then clamp the tubing.
6. Immerse all components Into the bowl of sterile physiologic solution.
7. Check that all of the Air bubbles have been removed from the tubing and the valve body prior to Implant.

CAUTION:
The presence of air bubbles in. the system will adversely affect valve function.

Note: Due to the physical characteristics of silicone elastomer, no shortl-term test of silicone elastomer valves can provide a precise indication of a valve's pressure designation or performance According to the FDA, patency and reflux are the only Issues that can be adequately addressed in a short-term OR test. For this reason, no OR pressure / flow test is recommended. For more information, refer to the pamphlet, "Pressure-Flow Characteristics as They Relate to the treatment of Hydrocephalus," available on request from PBC.

PRODUCT WARRANTY
Phoenix Biomedical Corp Warrants that, during manufacture, packaging and sterilization of Phoenix products, care was taken to make the devices suitable for use as indicated. Seller warrants that at the time of sale the goods shall be free from defects in workmanship and material. The foregoing warranty is in lieu of all other warranties, expressed or implied, and no other warranties exist including, without limitation, any warranty of merchantability or fitness for any other purpose other than that designated on the product insert sheet. Whether or not the device is appropriate for use in a particular patient depends on the nature of the patient's signs and symptoms, and such determination is the sole responsibility of the physician. If the goods do not conform to the warranty set forth herein, seller's sole liability and obligation shall be to replace the goods or refund the purchase price. In no event shall seller be liable for property damage, personal injury, or any consequential damages.
Product Description Subject to changes