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Integra LifeSciences Laparoscopic Instrument Care and Cleaning User Manual

Integra LifeSciences Health and hygiene

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PART 1 – LAPAROSCOPIC ENDOSCOPES

for medical use

IMPORTANT – PLEASE READ CAREFULLY BEFORE USING

Indications for use:

Miltex

®

endoscopes have specific 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 identified 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 flawless performance, look through the proximal

end of the endoscope into the light while rotating the

instrument clockwise. All surfaces should appear flat, 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

sufficient light illumination, connect the fiber optic light source

cable to the light connector/post fitting 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 fit most fiber optic

light cable sources to the endoscope light post. Simply screw the

appropriate adaptor on or off the fiber optic light post to

prepare the scope for connection to the fiber 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 fiber, 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 field of view to prevent accidental burns.

A sufficient 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