natus Camino 110-4HMT Gebrauchsanleitung Seite 4

Micro Ventricular Bolt Pressure-Temperature
Monitoring Kit is essential. Sterile technique
should be used at all times when inserting,
adjusting, and
Catheter.
• If monitoring is continued for more than
5 days, placement of a new system under
sterile conditions is recommended.
• Infection, subcutaneous leakage of CSF,
neurological sequelae, and blockage by
intraventricular debris (including bloody
and/or highly proteinic CSF) have occurred
during the use of ventricular catheters.
• Placement of the tip opening within the reach
of choroid plexus has resulted in blockage of
ventricular catheters.
• The ventriculostomy must be carried out by
a qualified neurosurgeon using standard
surgical procedures and skill. Hemorrhage
from the dura or cortical surface at the bolt
insertion site may occur. Patients should be
tested for normal blood clotting function prior
to bolt placement. Appropriate measures to
avoid infections and complications are the
sole responsibility of the neurosurgeon in
charge.
• This device utilizes PVC tubing which is
known to contain DEHP in a portion of the
drainage path which on occasion is used
for sampling and fluid injection. The risk of
exposure to the male fetus, male neonate,
and peri-pubescent male is not considered
significant for the following reasons: Sampled
and drained CSF is not intended to be
reintroduced into the patient. Injected fluids
such as anti-coagulants and saline solution
are only used as needed to eliminate or
reduce blockage of the ventricular catheter
and thus are not continuous in use.
PRECAUTIONS
• It is imperative that the ventricular catheter
not be handled with bare fingers or come
into contact with linty surfaces. Silicone
elastomers are
therefore susceptible to contamination by
airborne or surface particles. The presence
of these contaminants could cause adverse
tissue reaction. Rubber-shod clamps or
washed, gloved hands are the best means
of handling implantable silicone devices.
• Extreme bending and/or kinks can impair
the performance of the Fiber Optic Pressure
Transducer. Exercise caution when handling
the catheter.
• The catheter is designed for SINGLE USE
ONLY. DO NOT RESTERILIZE OR REUSE.
Camino 110-4HMT is supplied in a single use
2
securing the Camino
very electrostatic
package and is guaranteed to be sterile and
non-pyrogenic unless opened or damaged.
The catheter design incorporates a small
lumen and intricate sensors that are likely
to make it difficult to assure removal of all
contamination. Additionally, reprocessing is
likely to damage one or more of the delicate
sensors that may result in impaired function
(e.g. no or inaccurate measurements).
• The in-dwelling portion of the ventricular
catheter assembly is fabricated of barium-
impregnated silicone elastomer. Its OD is 3.7
mm and ID is 2.2 mm. Its length is adjustable
from 6–8 cm. Designed for directing fluid
from the ventricles through a series of
drainage holes, it can be inserted into the
ventricular cavity with the supplied stainless
steel stylet.
• Use aseptic technique throughout pro-
cedures.
• Maintain the insertion site with regular
meticulous
technique.
• Do not attach anything to transducer air vent.
Vent must remain open for proper operation
(Figure 1).
CAUTION
• Federal (U.S.A.) law restricts this device to
sale by or on the order of a physician.
• Connect the thermistor connector only to
Host Monitors marked "Patient connection
electrically isolated" or "BF" or "CF" or
marked with the international symbols:
• When connecting the thermistor connector
to a Host Monitor, refer to the Host Monitor's
operations manual for complete instructions.
• Verify proper operation of the combined Host
Monitor-110-4HMT System before clinical
use.
and
• The combined leakage currents of devices
interconnected with the 110-4HMT can lead
to a potentially hazardous condition. When
combined
ensure that the combined system leakage
current does not exceed 0.1 mA.
redressing using
or
with other devices/systems,
aseptic