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How Supplied - Depuy Synthes CODMAN MICROSENSOR Bedienungsanleitung

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Electrostatic Discharge (ESD)
Information
CAUTION: Exposure to electrostatic
discharge (ESD) energy could damage this
device. High levels of ESD could damage
the electronic components and cause the
transducer to be rendered inaccurate or
inoperable. Take all precautions to reduce
the buildup of electrostatic charge during
the use of this product.
• Provide patient grounding, e.g., grounding straps on
gurneys.
• Avoid the use of materials that could generate ESD
during patient movement and transport, e.g., nylon
transfer boards with bedding.
• 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
the ESD symbol and training in ESD precautionary
procedures. Training should include, at a minimum, an
introduction to electrostatic discharge, when and why
it occurs, precautionary measure, and the damage
that can be done to electronic components if touched
by a user who is electrostatically charged.
Avoid touching the connector pins, which are
identified with the ESD symbol, before following
ESD precautionary procedures. Avoid touching the
transducer tip (sensing element) at all times.

How Supplied

This device is intended for SINGLE USE ONLY;
DO NOT RESTERILIZE.
Codman 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.
Codman & Shurtleff 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.
As long as the individual package is not damaged or
opened, the product is sterile.
All components have been tested and were
determined to be nonpyrogenic, except for the
electrical connector of the sensor and the silicone
tubing used for packaging, which are not tested.
The device is packaged using a combination of
recyclable and non-recyclable materials. Recycle or
dispose of all packaging waste in accordance with
hospital procedures and regulations.
Connecting and Zeroing the
MICROSENSOR Transducer
CAUTION: The transducer must be zeroed at
atmospheric pressure before implantation.
1. Connect the transducer to a compatible
CODMAN ICP Monitor using an appropriate
CODMAN interface cable. Refer to
instructions for use provided with the cable for
sterilization information.
2. If applicable, connect the CODMAN ICP Monitor
to an available pressure channel on an external
patient monitor using a CODMAN Patient Monitor
Interface Cable.
CAUTION: Use CODMAN Patient Monitor
Interface Cables only with the patient monitors
for which they are specifically designed
and designated.
3. Zero and calibrate the external patient monitor
according to the instructions provided with the
CODMAN ICP monitor, as well as the external
patient monitor manufacturer's instructions.
4. Prepare to zero the catheter by laying the tip of
the catheter 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 catheter horizontally just under the
surface of the sterile water or sterile saline.
CAUTION: Do not submerge the tip of the
catheter vertically in a deep pool or cup of
sterile water or sterile saline. Doing so will
impose a hydrostatic pressure on the sensor
diaphragm that is higher than atmospheric
pressure, resulting in an inaccurate zero
reference.
5. While keeping the tip of the catheter flat and
still in the sterile water or sterile saline, zero the
catheter according to the instructions provided
with the ICP Monitor.
CAUTION: The sensor tip must remain wet
during the zeroing process. CAUTION:
The sensor tip must remain still during
the zeroing process. Motion of the sensor
may be interpreted by the CODMAN ICP
Monitor as a fluctuating ICP signal which
will prevent the sensor zeroing process from
successfully completing.
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