Integra Codman CereLink Manual Del Usuario página 8

EN – ENGLISH
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. Using
the provided 2.7 mm drill bit, drill a 2.7 mm hole through the outer table of the
skull. CAUTION: Bolt fit can be compromised if used with other drills
3. Open the dura with a sharp instrument, such as an 18-gauge spinal needle, or
similar.
4. If desired, adjust the seating depth of the bolt using the washer provided.
5. Condition the compression cap and sensor locking mechanism before installation
of the bolt. First, hand-tighten the compression cap by turning it clockwise. Then
loosen the cap by turning it counterclockwise the same or a lesser amount.
6. Put the skull bolt in position and screw manually in a clockwise direction
until properly seated (see Figure 3). CAUTION: Do not loosen the cap during
installation of the bolt WARNING: Excessive torque applied to the skull bolt
during insertion can cause breakage Installation of the skull bolt must be
performed with the bolt held within 10° of perpendicular to the incision site
Installing at an angle may result in fracture of the ICP Sensor
7. Use the obturator/dura pierce to clear the pathway through the bolt and to further
open the dura (see Figure 4). CAUTION: Do not plunge the obturator Carefully
push the obturator until the dura has been pierced
8. Irrigate the channel with non-bacteriostatic sterile saline (see Figure 5).
9. Guide the ICP Sensor through the bolt until the ICP Sensor tip is in the subdural or
parenchymal space (see Figure 6).
10. Turn the compression cap firmly in a clockwise direction to secure the ICP
Sensor (see Figure 7). WARNING: If the skull bolt compression cap is not initially
tightened properly, ICP Sensor movement and/or leakage can occur If during the
implantation period the patient is moved or becomes active, check the security
of the ICP Sensor in the skull bolt compression cap and tighten, if necessary
11. Remove retractor and close the skin incision in one layer using interrupted sutures
(see Figure 8). Apply appropriate dressing to wound site.
7
Removing the Skull Bolt
1. Loosen the compression cap by turning in a counterclockwise direction.
2. Carefully withdraw the ICP Sensor from the bolt assembly.
3. Manually unscrew the bolt in a counterclockwise direction until the bolt is free.
CAUTION: Make certain that the depth washer, if used, has 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.
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