Integra Codman CereLink Manual De Instrucciones página 9

Connecting and Zeroing the ICP Sensor
CAUTION: The ICP Sensor must be zeroed at atmospheric pressure before implantation.
1. Connect the ICP Sensor to the ICP monitor using an appropriate Codman
Extension Cable. Refer to instructions for use provided with the Extension Cable
for sterilization information.
2. If applicable, connect the ICP monitor to an available pressure channel on
an external patient bedside monitor using a Patient Monitor Interface Cable.
CAUTION: Use Codman Patient Monitor Interface Cables only with the patient
bedside monitors for which they are specifically designed and designated.
3. If applicable, zero and calibrate the external patient bedside monitor according
to the instructions provided with the ICP monitor, as well as the external patient
bedside monitor manufacturer's instructions.
4. Prepare to zero the ICP Sensor by laying the tip of the ICP Sensor flat in a shallow
pool of sterile water or sterile saline. The accompanying sterile blister package
has a marked well that is suitable for this procedure. Pour sufficient sterile
water or sterile saline into the well, then lay at least a 5 cm section of the ICP
Sensor horizontally just under the surface of the sterile water or sterile saline.
CAUTION: Do not submerge the tip of the ICP Sensor vertically in a deep pool or
cup of sterile water or sterile saline. Doing so will impose a hydrostatic pressure
on the ICP Sensor diaphragm that is higher than atmospheric pressure, resulting
in an inaccurate zero reference.
5. While keeping the tip of the ICP Sensor flat and still in the sterile water or sterile
saline, zero the ICP Sensor according to the instructions provided with the ICP Monitor.
CAUTION: The ICP Sensor tip must remain wet during the zeroing process.
CAUTION: The ICP Sensor tip must remain still during the zeroing process. Motion of
the ICP Sensor may be interpreted by the ICP monitor as a fluctuating ICP signal which
will prevent the ICP Sensor zeroing process from successfully completing.
General Surgical Procedure
The following is a general guide for informational purposes only. The surgeon may wish to
alter details in accordance with his or her own clinical experience and medical judgment.
The Codman Cranial Access Kit is recommended for this procedure.
Installing the Skull Bolt
1. Connect and zero the ICP Sensor. Refer to Connecting and Zeroing the ICP Sensor.
2. Perform craniotomy and retraction procedures required to expose the skull.
Drill a 5.8 mm hole through the outer table of the skull. CAUTION: Bolt fit can be
compromised if used with drill bits other than those provided by Integra. Make
a cruciate puncture in the dura to establish an assured path between the bolt and
the intraparenchymal area.
3. Select adult or pediatric bolt.
Note: If necessary, adjust the seating depth of the bolt using the spacing washers
provided. Two washers can be used with the adult skull bolt and one can be used
with the pediatric skull bolt to adjust for variations in skull thickness in patients.
Position spacing washers prior to insertion of the bolt. The range of adjustment
available to the surgeon is:
Pediatric: 3.5 mm to 5 mm
Adult: 5.0 mm to 10 mm
WARNING: Do not remove the thrust washer and sealing washer that are
preassembled on the skull bolt, as this can result in a fracture of the device or in
an inadequate seal between the washer and the skull.
Note: Do not remove the obturator from the skull bolt.
4. Put the skull bolt into position and place the screw handle on top of the bolt (see
Figure 4). Turn the screw handle clockwise until the spacing washer beneath the
screw flange rests close against the outer table of the skull. Remove the screw
handle. WARNING: Excessive torque applied to the skull bolt during insertion
can cause breakage. This device is designed to break off at the area between
the hexagonals, if excessive torque is applied. The lower portion of the screw
can then be removed using the screw handle. To remove the bolt, turn the screw
handle counterclockwise.
5. Remove the obturator from the skull bolt.
6. Guide the ICP Sensor through the bolt until the tip is in the subdural or
parenchymal space (see Figure 5).
7. Irrigate the channel with non-bacteriostatic sterile saline.
8. Loosen the Tuohy-Borst adapter from the catheter body by twisting the blue
adapter counterclockwise. Slide the Tuohy-Borst adapter into place
(see Figure 6). Turn the blue adapter clockwise to secure.
9. Remove the retractor and close the skin incision in one layer using interrupted
sutures (see Figure 7). Apply appropriate dressing to the wound site.
Note: If desired, the male luer cap may be used to occlude the bolt outlet when
monitoring is discontinued.
Removing the Skull Bolt
1. Remove the ICP sensor and all connections from the skull bolt.
2. Remove the dressing around the bolt and one or two sutures closest to the stem.
3. Using the sterile screw handle provided, turn the screw counterclockwise until
free. CAUTION: Make certain that all the washers have been removed from the
incision area before closing.
4. Apply pressure with sterile gauze until hemostasis is achieved. Close the incision
again in one layer with uninterrupted sutures. Apply a dry sterile dressing.
Specifications
Device Specifications
Note: All performance specifications based on 5 VDC excitation voltage
Sensing element
Device usable length
Sensor material
Sensor tip diameter
Device tubing diameter
Functional pressure range
Functional overpressure range without
damage
Input/output impedance
Zero drift
Output signal (sensitivity)
Frequency response
Environmental Specifications
(for non-implantable portion of device)
Operating temperature range
Operating humidity range
Operating atmospheric pressure range
PRODUCT INFORMATION DISCLOSURE
INTEGRA LIFESCIENCES CORPORATION ("INTEGRA") HAS EXERCISED REASONABLE CARE
IN THE SELECTION OF MATERIALS AND THE MANUFACTURE OF THESE PRODUCTS.
INTEGRA WARRANTS THAT THESE PRODUCTS SHALL CONFORM TO THE PRODUCT
LIMITED WARRANTY AS PROVIDED IN THE PRODUCT LABELING OR APPLICABLE
PRODUCT CATALOG. THIS WARRANTY IS EXCLUSIVE AND INTEGRA DISCLAIMS ALL
OTHER WARRANTIES, WHETHER EXPRESSED OR IMPLIED, INCLUDING BUT NOT
LIMITED TO, ANY IMPLIED WARRANTIES OF MERCHANTABILITY OR FITNESS FOR A
PARTICULAR PURPOSE. INTEGRA SHALL NOT BE LIABLE FOR ANY INCIDENTAL OR
CONSEQUENTIAL LOSS, DAMAGE, OR EXPENSE, DIRECTLY OR INDIRECTLY ARISING
FROM USE OF THESE PRODUCTS. INTEGRA NEITHER ASSUMES NOR AUTHORIZES ANY
PERSON TO ASSUME ANY OTHER OR ADDITIONAL LIABILITY OR RESPONSIBILITY IN
CONNECTION WITH THESE PRODUCTS.
8
EN – ENGLISH
Strain gauge silicon microchip
100 cm nominal
Nylon, titanium, silicone, epoxy
1.3 mm maximum
0.8 mm maximum
–50 mmHg to +250 mmHg
–700 mmHg to +1250 mmHg
1000 ohms nominal
No greater than 5 mmHg over 30 days
5 µV/V/mmHg nominal
Greater than 200 Hz
5°C to 45°C
30% to 90% relative humidity
(non-condensing)
700 millibar to 1060 millibar