Device Specifications - Integra Codman CereLink 826850 Guia De Inicio Rapido

EN – ENGLISH
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.
Measuring Subdural Pressure
1. Following craniotomy and bone flap removal, connect and zero the device. Refer to
Connecting and Zeroing the ICP Sensor.
2. Choose the burr hole through which the ICP Sensor will be placed and bevel the
edge on the side the device will exit to facilitate removal.
3. Use the Tuohy needle to tunnel under the scalp from the craniotomy site to the
desired device exit site.
4. Remove the Tuohy needle stylet and thread the ICP Sensor from the tip of the
needle until the approximate length for desired placement exits from the hub.
See Figure 2. CAUTION: The inner edges of the Tuohy needle are sharp; exercise
caution when threading the device.
5. Gently remove the needle and estimate the length of the ICP Sensor from the tip
to the desired location for the first bend.
6. Fold the ICP Sensor at the desired bend site to leave a kink in the tubing. Verify
that the kink is on the opposite side of the sensing element, as shown in Figure 3.
7. Place the tip of the ICP Sensor on the brain tissue under the dura opposite the
beveled burr hole. The kink must be placed at the bottom of the burr hole so that
the sensing element faces the cortex, as shown in Figure 4.
CAUTION: To ensure accurate ICP measurements, position the sensing element
towards the cortex during subdural pressure monitoring.
CAUTION: To minimize movement artifacts of the bone flap, place the ICP Sensor
under the intact skull.
8. Close and suture down the dura following standard neurosurgical procedure.
9. Replace the bone flap and close the scalp incision.
10. Secure the catheter to the scalp. To provide additional strain relief, make a small
loop with the excess ICP Sensor tubing and tie the loop down.
11. Close and dress the incision site.
Measuring Intraparenchymal Pressure
NOTE: The Codman Cranial Hand Drill is recommended for this procedure. This hand drill
is also found as a component in Codman Cranial Access Kits
1. Connect and zero the device. Refer to Connecting and Zeroing the ICP Sensor.
2. Perform craniotomy and retraction procedures required to expose the skull. Drill
a 2.7 mm hole through the outer table of the skull. CAUTION: Proceed gently
through the inner table with care to avoid injury to the dura or parenchyma.
3. Carefully bevel the bone at the incision site towards the side from which the device
will exit.
4. Use the Tuohy needle to make a cruciate puncture in the dura.
5. Use the Tuohy needle with stylet in place to tunnel under the scalp from the
incision site to the exit site.
6. Remove the stylet and thread the ICP Sensor from the tip of the needle through
the hub of the needle until approximately twice the placement length exits from
the hub. See Figure 5. CAUTION: The inner edges of the Tuohy needle are sharp;
exercise caution when threading the device.
7. Gently remove the needle and estimate the length of the ICP Sensor from the tip
to where it will bend upon exiting the skull.
7
8. Fold the ICP Sensor at the desired bend site to leave a kink in the tubing.
9. Place the tip of the ICP Sensor into the parenchyma through the puncture in the
dura until the kink is at the edge of the hole, as shown in Figure 6.
10. Carefully pull back the excess ICP Sensor tubing.
11. Remove the retractor, verify hemostasis in the insertion area, and then suture the
incision site closed.
12. Secure the catheter to the scalp. For additional strain relief, make a small loop with
the excess ICP Sensor tubing and tie the loop down.
13. Close and dress the incision site.
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