Codman EDS 3 Manual De Instrucciones página 3

The EDS 3 system without Catheter (catalog no. 82-1731) comprises the
external component only for replacement purposes. A male LUER-LOK
connector with cap is provided for connection with a 1.5 mm inner-diameter
silicone ventricular drainage catheter. The above products are provided sterile.
Note: Collection bag volume measurement ±20 ml, or ±10% of actual liquid
volume. Drip Chamber volume measurement ±1%.
The CODMAN EDS 3 Leveling Device (catalog no. 82-1733) is a nonsterile
accessory designed for use with the CODMAN EDS 3 CSF External Drainage
System. The EDS 3 Leveling Device consists of a laser-pointing device
permanently encased in a mounting bracket that allows for attachment to
and use with the CODMAN EDS 3 System.
Please see the label affixed to the leveling device (Figure 1a), which reads:
LASER RADIATION
DO NOT STARE INTO BEAM
CLASS 2 LASER PRODUCT
Diode Laser
Maximum Output <1 mW
Wavelength 630–680 nm
EN/IEC 60825-1 Ed.2.0:2007
This device complies with 21 CFR
Part 1040.10 and 1040.11 except for
deviations pursuant to Laser Notice
no. 50, dated June 24, 2007
CODMAN & SHURTLEFF, INC.
325 Paramount Drive
Raynham, MA 02767 – USA
MANUFACTURED: MONTH YEAR
The following components are available separately for use with the
CODMAN EDS 3 CSF External Drainage System.
Catalog No. Description
82-1732 CODMAN External Drainage System Collection Bags
(sterile), package of five (5)
82-1735 CODMAN EDS 3 Clear Ventricular CSF Catheter (sterile)
82-1738 CODMAN Lumbar Catheter Kit II with EDS 3 CSF External
Drainage System
82-1733 CODMAN EDS 3 Leveling Device
Contraindications
Use of this device is contraindicated if scalp infection is present.
Use of this device is contraindicated for patients receiving anticoagulants or
for patients who are known to have a bleeding diathesis.
Use of this device is contraindicated where 24-hour supervision from trained
personnel is not available.
WARNINGS
Intracranial pressure is controlled by the height of the Drip Chamber
relative to the patient. It is important that neither the Drip Chamber nor the
patient be raised or lowered accidentally. If either is raised or lowered, it is
imperative to re-level the drainage system.
Close the two clamps at the top of the collection bag if it is necessary to
invert the EDS 3 unit. This will prevent liquid from wetting the vent at the top
of the bag, which will prevent proper drainage, and will prevent liquid from
refluxing to the drip chamber.
Close the Patient Line stopcock before transporting the patient to reduce the
risk of liquid refluxing to the patient.
The height of the Drip Chamber or the position of the patient should only be
changed by qualified personnel on the orders of a physician.
Movement by the patient after positioning of the Drip Chamber may affect
the patient's ICP.
The EDS 3 System provides direct access to the ventricular drainage
catheter via the patient line stopcock and the needle-free injection site. Care
must be taken when administering medication through these locations to
minimize the chance of intravascular medications being injected into the
cerebrospinal fluid.
When using a lumbar catheter, take care not to withdraw the catheter
after insertion into the Tuohy needle. If the catheter must be removed,
to minimize the risk of damage to the catheter, withdraw the Tuohy needle
and catheter simultaneously.
Finger-tighten all stopcock caps before using the system. Connections may
loosen during shipping and handling. (Do not attempt to tighten or remove
the needle-free injection port. This component is glued in place.)
Do not leave the EDS 3 system in the Monitoring Only position if shunting
(draining) is the primary function. Always return the EDS 3 stopcocks to the
Drainage Only position to resume draining.
Monitoring ICP with a stopcock in the Null position may result in false
ICP readings. Simultaneous drainage and transducer monitoring may
result in waveform artifacts and artificially low ICP readings as described
by Wilkinson 5 . Alternate drainage and ICP monitoring can be achieved by
adjusting the stopcocks to either the Drainage Only position for drainage
or the Monitoring Only position for ICP monitoring.
If the system or drip-chamber stopcock is turned to the Monitoring Only
position or Off position during ICP monitoring or flushing of the system, it
must be returned to the Drainage Only position in order to resume draining.
Care should be taken not to raise or lower the Drip Chamber when
calculating the drainage rate.
Magnetic Resonance Imaging (MRI) Information
CAUTION: Remove the Laser Leveling Device (catalog no. 82-1733)
from the EDS 3 System before entering the MRI suite. This component
is MR unsafe.
The CODMAN EDS 3 CSF External Drainage System, with the exception
of the CODMAN EDS 3 Leveling Device, has exhibited no magnetic field
interactions associated with exposure to 1.5 T and 3.0 T MRI systems.
PRECAUTIONS
Refer to manufacturer's instructions when using components other
than Codman's.
Inspect the sterile package carefully. Do not use if:
• the package or seal appears damaged,
• contents appear damaged, or
• the expiry date has passed.
Aseptic technique is necessary in all phases of the use of this product.
Exercise extreme care to prevent the ventricular catheter from coming
in contact with bare fingers, towels, drapes, talc, or any linty or granular
surfaces. Silicone rubber is highly electrostatic and therefore attracts
airborne particles and surface contaminants that could produce
tissue reaction.
Silicone rubber cuts and tears easily. Use rubber shod forceps when
handling the catheter.
It is recommended that the catheter be sutured to the LUER-LOK hub
to prevent possible separation of the components when the catheter
is removed.
Exercise care when placing ligatures to avoid cutting or occluding the tubing.
The use of stainless steel ligatures on silicone products is not recommended.
To prevent contamination, do not touch the inside threads or surface of the
LUER-LOK cap with bare fingers. Do not set the LUER-LOK cap on a non-
sterile surface.
Do not attempt to access the silicone seal of the needle-free injection/
sampling site using a needle or blunt cannula. To prevent damage to the
seal, access using standard Luer connection devices only.
Do not allow residue from disinfectants to remain on the inner surfaces of the
LUER-LOK connectors. Such residue might cause the components to stick
together. Contact the manufacturer of the disinfectant for further information.
To reduce the likelihood of infection, it is recommended that care of
the catheter exit site and the connection to the external drain be carried
out in accordance with principles established for the care of long-term
hyperalimentation catheters.
Always attach the EDS 3 Device to the I.V. pole by fitting the clamp over
the pole. Tighten the blue screw to secure the system in place. The locking
mechanism is available as a secondary safety feature and must not be the
primary method of attaching the system to the pole.
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