Integra-lifesciences Laparoscopic Instrument Care and Cleaning User Manual

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1
PART 1 – LAPAROSCOPIC ENDOSCOPES
for medical use
IMPORTANT – PLEASE READ CAREFULLY BEFORE USING
Indications for use:
Miltex
®
endoscopes have specic indications for use and the
user should appropriately decide whether the instrument is
suitable for the desired application. Miltex cannot provide any
warranty for results due to incorrect application.
It is recommended that each device is used in approved
endoscopic procedures by physicians experienced in the art of
endoscopy. These instructions are recommended for the proper
function of the device. This material is not intended as a
reference for endoscopic examination or surgery, nor is it
intended to replace training, including relevant preceptorship(s).
The autoclavable endoscopes are identied by the word
AUTOCLAVABLE’ on the instrument.
The endoscopes will be sold as non-sterile, reusable
instruments.
For the purpose of these care and handling instructions,
Miltex
®
endoscopes are referred to collectively as Scopes,
Telescopes, Laparoscopes or Endoscopes.
1. EXAMINING THE ENDOSCOPE
The endoscope should be examined upon receipt from the
supplier as well as before and after each surgery or use.
Take particular care to inspect for scratches and dents on the
tubing of the distal and/or proximal ends of the instrument
which could be indicators of damage to the endoscope.
To ensure awless performance, look through the proximal
end of the endoscope into the light while rotating the
instrument clockwise. All surfaces should appear at, shiny
and without any distortion. Moisture inside the endoscope and
damaged rod lenses will cause a cloudy/hazy image or possibly
the complete loss of image.
Before using the endoscope, also check the light connector and
distal optic surfaces to verify that they are clean and
undamaged. The ACMI, Wolf, and Storz/Olympus light adaptors
may need to be removed in order to inspect properly. To ensure
sucient light illumination, connect the ber optic light source
cable to the light connector/post tting on the endoscope. The
light exiting the distal end of the endoscope should be an evenly
distributed ball of light without any dark areas.
Fiber Optic Light Post Adaptor Assembly:
The following demonstrates proper mechanical assembly procedures
for the endoscopes. Adaptors can be used to t most ber optic
light cable sources to the endoscope light post. Simply screw the
appropriate adaptor on or o the ber optic light post to
prepare the scope for connection to the ber optic light cable.
Cautions and warnings:
Please be aware that improper use may lead to patient injuries
and/or damage to the endoscope. Due to the high energy
radiated light emitted from the illumination ber, the distal end of
the endoscope may reach temperatures exceeding 41ºC (108ºF)
within a distance of 8-10mm from the front of the scope.
To avoid burns to the patient, do not leave the tip of the endoscope
in direct contact with tissue or combustible materials. Lower the
light source output when working in close proximity to
the object.
If high-frequency (HF) electrosurgical instruments are used,
please take caution to ensure that the working element of such
instruments is kept within eld of view to prevent accidental burns.
A sucient distance from the tip of the endoscope to other
conductive accessories and instruments should be maintained
before activating the HF output.
Endoscopes are fragile optomechanical devices that need to be
handled with caution. To avoid damage to the endoscope caused
by laser burn or exposures, it is necessary to keep the laser
delivery system away from all parts of the endoscope.
To avoid fogging during surgery, the rear proximal portion of
the scope must be entirely free of moisture before it is attached
to the camera or coupler.
Extreme heat from steam autoclaving and the high intensity
lamp will cause debris on the optical surfaces to possibly
discolor, burn and harden if not properly cleaned and removed.
Always hold the endoscope at the housing body and/or eyepiece.
Do not bend the shaft of the scope.
Avoid shaking or dropping the endoscope.
INSTRUCTIONS FOR CARE & CLEANING OF
MILTEX
®
ENDOSCOPES AND LAPAROSCOPIC
SURGICAL HAND INSTRUMENTS
Instructions for Use/English
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Summary of Contents

Page 1 - SURGICAL HAND INSTRUMENTS

1PART 1 – LAPAROSCOPIC ENDOSCOPES for medical useIMPORTANT – PLEASE READ CAREFULLY BEFORE USINGIndications for use:Miltex® endoscopes have specic i

Page 2

22. CLEANING:The endoscope has three optical surfaces that must be cleaned and inspected routinely to ensure both maximum transmission of illuminati

Page 3

34.1. GAS STERILIZATION (cont.)Sterilization parameters Ethylene Oxide Carrier: Oxyfume 2002Temperature: 55 ± 2°C (131 ± 5°F)Relative Humidity

Page 4 - Instructions for Use/English

4PART 2 - LAPAROSCOPIC SURGICAL HAND INSTRUMENTS for medical use IMPORTANT – PLEASE READ CAREFULLY BEFORE USING Indications for use:Miltex® laparos

Page 5

5Thoroughly inspect instruments for eective cleaning (free from any visible dirt and residue). Also inspect the instruments for any damaged, worn,

Page 6 - LAP-CARE

6LAP-CAREMiltex is a registered trademark of Miltex, Inc., a subsidiary of Integra LifeSciences Corporation. Miltex Redefining Excellence is a tradema

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