Integra INS301 Bedienungsanleitung Seite 2

Intended Population
Any patient eligible in line with the
intended purpose.
Contraindications
This device is not designed, sold,
or intended for use except as indi-
cated.
Instructions for Use
Alignment/Removal/Replacement
• Securely attach the Pole Mount
Assembly to IV pole by tighten-
ing the locking knob located on
the side of the pole mount base.
(Fig. 1)
• Align pole mount sliding adapter
to zero reference point on gradu-
ated rail and lock in place using
adapter knob located on the side
of the graduated scale. (Fig. 1)
• Align zero point on the graduat-
ed rail to the patient's anatom-
ical reference point using the
attached laser level or line level.
Both should be replaced if dam-
aged.
When Using The Laser Level
(Fig. 4):
• Remove the battery cover from
the rear side of the laser level.
• Insert two "N" size batteries into
the battery compartment on the
laser level.
• Replace the battery compart-
ment cover.
• Attach the laser level to the pole
mount base by sliding laser level
bracket into the groove located
behind the pole mount base. En-
sure the laser level bracket snaps
securely in place. (Fig. 2)
• Ensure the laser is level with the
pole by adjusting the laser level
so that the bubble is centered
in-between the two lines located
on the top of the level.
• Depress the power switch (cau-
tion: do not stare into light
beam).
• Adjust height of the pole mount
so that the light beam is aligned
with the patient's anatomical
reference point. (the light beam
will automatically turn off in
30 seconds).
When Using a Line Level:
• Attach line level by pressing line
level fastener into the desig-
nated hole located on the pole
mount base, ensuring line level
snaps securely in place. The line
level can also be used to level the
patient to the zero reference by
unwrapping and extending the
black ring to the patient's head,
adjacent to the Foramen of Mon-
ro or to the patient's side at level
of lumbar catheter. Ensure that
patient and zero point on pan-
el are leveled by checking the
bubble in viewfinder. Adjust pole
mount until bubble is centered
(Line level may be stored in the
grooved area in the pole mount
base.) The line level is a replace-
ment component and can be
easily removed by pulling from
the pole mount base.
Attaching Drainage System
• Attach the drainage system to
the mounting bracket.
• Place the mounting bracket on
the notch located on the pole
mount sliding bracket and se-
cure in place by turning the
locking knob on the side of the
mounting bracket. The INS301
adaptor (Fig. 3) is needed with
panel mounting systems.
• Increase or decrease the height
of the pressure level by moving
the pole mount sliding bracket
up or down and locking in place
by turning the adapter knob.
2
• Refer to the External CSF Drain-
age System instruction for use
for instructions on system setup.
Instructions for Use
Set-UP and Connection to Patient
Use sterile technique during set-up
and use of the External CSF Drain-
age system. Refer to the External
CSF Drainage Systems Instruction
for use for completed instructions
for system set-up and connection
to patient.
Do Not Sterilize
The Pole Mount Assemblies are
reusable devices and should be
cleaned and maintained by using
aseptic techniques and solutions
in accordance with the established
facility procedures.
Notice: Any serious incident that
has occurred in relation to the
device for the user and/or the pa-
tient should be reported to the
manufacturer and the competent
authority of the member state in
which the user and/or patient is
established.
Warnings
Patients with cerebrospinal fluid
drainage systems must be kept un-
der close observation for signs and
symptoms of changing intracranial
pressure. These signs and symp-
toms may vary from patient to pa-
tient. Increased intracranial pres-
sure may be characterized by, but
not limited to, headache, vomiting,
irritability, listlessness, drowsiness,
other signs of deterioration of con-
sciousness, and nuchal rigidity.
In an infant, increased scalp ten-
sion at the anterior fontenelle and
congestion of scalp veins may be
noted.
Failure to appropriately adjust the
rate of CSF outflow through the
external drainage system may re-
sult in potential serious injury to
the patient. Patients undergoing