Codman MICROSENSOR Manual página 7

• Before touching the patient, caretakers
should discharge ESD buildup by touching a
grounded metal surface, such as a bed rail.
It is recommended that all hospital personnel in
contact with these devices receive an explanation
of ESD and training in ESD precautionary
procedures. Training should include, at a minimum,
an introduction to electrostatic discharge, when
and why it occurs, precautionary measures,
and the damage that can be done to electronic
components if touched by a user who is
electrostatically charged.
Avoid touching the connector pins before following
ESD precautionary procedures. Avoid touching the
transducer tip (sensing element) at all times.
Sterilization
The CODMAN MICROSENSOR Basic Kit is
intended for SINGLE USE ONLY; DO NOT
RESTERILIZE. Integra single-use devices have
not been designed to undergo or withstand
any form of alteration, such as disassembly,
cleaning or resterilization, after a single patient
use. These devices are intended to come into
contact with the central nervous system and the
ability does not currently exist to destroy possible
contaminates such as Creutzfeldt-Jakob Disease.
Reuse can also compromise device performance
and any usage beyond the design intent of this
single-use device can result in unpredictable use
hazards or loss of functionality.
Integra will not be responsible for any product that
is resterilized, nor accept for credit or exchange
any product that has been opened but not used.
All components have been tested and were
determined to be nonpyrogenic, except the
electrical sensor, the barcode label, the string
catheter, and if present, the disposable ICP handle
and the hexagonal key, which are not tested.
MICROSENSOR Specifications
Sensing Element ......Strain gauge silicon micro chip
Diameter of tip .........3.6 Fr (1.2 mm), nominal
Usable length ...........100 cm nominal
Catheter outside
diameter ...................0.7 mm nominal
Catheter material .....Nylon
Functional pressure
range ........................ –50 mm Hg to +250 mm Hg
Functional
overpressure range
without damage .......–700 mm Hg to +1250 mm Hg
Input impedance ......1000 ohms nominal
Excitation range .......2.5 V to 7.5 VDC or VAC RMS
Zero drift ...................no greater than 5 mm Hg
Zero offset ................±50 mm Hg (±6666 Pa)
Output impedance ...1000 ohms nominal
Leakage current .......less than 10 µA at 120 VAC
Output signal
(sensitivity) ................5 µV/V/mm Hg (5 µV/V/133 Pa)
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.
Codman, Codman Microsensor, and ICP Express are
registered trademarks of Integra LifeSciences Corporation
or its subsidiaries in the United States and/or other
countries.
Microsensor is a trademark of Integra LifeSciences
Corporation or its subsidiaries.
4
(–6666 Pa to +33330 Pa)
(–93324 Pa to +166650 Pa)
(performance based on 5 VDC)
(667 Pa)/7 days
maximum
nominal