Stryker X8000 - Device Description and Specifications; Technical Specifications

4
Warnings and Cautions
Please read this
manual and follow its instructions carefully
.

e words warning, caution, and note carry special
meanings and should be carefully reviewed:
W
arning
W
arnings
indicate
risks
to
the
safety
of the patient or us
er
. Failure to follow
warnings may result in injury to the
patient or
user.
Caution
Cautions
indicate
risks
to
the
equipment. Failure to follow cautions
may result in product damage.
Note
Notes
provide
special
information
to
clarify instructions or present additional
useful information.
An exclamation mark within a triangle
is intended to alert the user of special
warnings or important operating and
maintenance instructions in the manual.
A
lightning
bolt
within
a
triangle
is
intended to warn of the presence
of
hazardous voltage. Refer all service to
authorized personnel.

e incorrect use
of any of the required tools and/or
techniques may risk damage to the equipment or injury to
the person carr
ying out the procedure, subsequent operator
s,
or patient. Perform the repair ONLY if you have been
speci
fi
cally trained in the use of all pertinent equipment
and techniques. Stryker Endoscopy cannot continue to
guarantee compliance to UL, CSA,
TUV
, or other
labeled
safety standards if service is performed by anyone other than
Stryker Endoscopy personnel.
T
o help avoid potential serious injury to the us
er and the
patient and/or damage to this device:
1.
Read
this
manual
thoroughly
,
especially
the
warnings, and be familiar with its c
ontents prior to
using this
equipment.
2.
Never
sterilize
any
part
of
the X8
000
console.
3.
Disconnect
the
X8000
from
the
electrical
outlet
when inspecting the fuses.
4.
Ensure
that
readjustments,
modi
fi
cations, and/
or repairs are carried
out exclusively by Stryker
Endoscopy or other authorized personnel.
5.
Ensure
that
the
electrical installa
tion
of
the
relevant
operating room complies with the applicable IEC,
CEC, and NEC requirements.
Federal law (United States of America) restricts this device
to use by, or on order of, a
physician.
IMPORTANT SAFETY NOTICE
Before operating or per
forming any maintenance or
repairs on the X8000 Light Source, read the user guide
and service
guide thoroughly and carefully. When using
any light source, such as the
X8000,
fi
re and/or severe
injury may result to the patient, user
or inanimate
objects, if the instructions in this manual are not
followed.
All light sources, including the X8000, can generate
signi
fi
cant amounts of heat at the scope tip, the scope
light post, the light cable tip, and/or near the
light cable
adapter
. Higher levels
of brightness from the light
source
result in higher levels of heat.
To avoid the risk of burns and/or
fi
re:
•
Always
adjust
the
brightness
level
of
the
camera
and the
monito
r before adjusting the
brightness
level of the light source.
•
Adjust
the
brightness
level
of
the
light
source
to
the minimum brightness necessary to adequately
illuminate the surgical site.
•
Adjust
the
internal
shutter
of
the
camera
higher
in order to run
the light source at a lower
intensity.
•
Avo
id
touching
the
scope
tip
or
the
light
cable
tip to the patient, and never
place them on top
of the patient, as doing so may result in
burns to
the patient or use
r.
•
Never
place
the
scope
tip,
the
scope
light
post,
the light cable
adapter
, or the
light cable tip on
the surgical drapes or other
fl
ammable material,
as doing so may result in
fi
re.
•
Always
place
the
light
source
in
Standby
mode
whenever the scope is removed from the light
cable or the device is unattended.

e scope
tip, scope light post, light cable
adapter
, and
light cable tip will take severa
l minutes to cool
o
ff
a

er being placed in
Standby mode, and
therefore may still result in
fi
re or burns to the
patient, user, or inanimate objects.