INSTRUCTIONS FOR CARE & CLEANING OF
MILTEX® ENDOSCOPES AND LAPAROSCOPIC
SURGICAL HAND INSTRUMENTS
PART 1 – LAPAROSCOPIC ENDOSCOPES
for medical use
IMPORTANT – PLEASE READ CAREFULLY BEFORE USING
Indications for use:
Miltex® endoscopes have specic 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 identied by the word
‘AUTOCLAVABLE’ on the instrument.
Instructions for Use/English
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
sucient 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.
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 sucient 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.
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.
• 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.
1
INSTRUCTIONS FOR CARE & CLEANING OF
MILTEX® ENDOSCOPES AND LAPAROSCOPIC
SURGICAL HAND INSTRUMENTS
Instructions for Use/English
2. CLEANING:
The endoscope has three optical surfaces that must be
cleaned and inspected routinely to ensure both maximum
transmission of illumination and a high quality image.
Distal Optic
Eyepiece/Proximal
Optic Surface
Fiber Optic Surface
All optics and surfaces of the scope should be cleaned with
warm water and a pH-neutral cleaning and disinfecting
solution recommended for reprocessing medical
endoscopes. Remove the light post ttings and let the
endoscope soak inside the pH-neutral solution. Closely follow
the manufacturer’s instructions for appropriate chemical
concentrations and immersion time. Thoroughly rinse the
endoscope and ttings to remove the cleaning solution. After
the scope and ttings are dry, inspect the instrument for any
remaining stains. It is important to closely check the three
optical surfaces, as detailed above, to ensure that proper
cleaning has been achieved for optimum performance.
Note: Never clean and/or sterilize endoscopes together with
other instruments unless they are individually secured within a
specialized cleaning container.
Removing stains or deposits on optical surfaces:
Insucient cleaning or foreign matter in steam during
autoclaving process may leave deposits on any of the three
optical surfaces of the endoscope. If stains or particles are
still present on any of the optical surfaces after cleaning, use
an enzymatic solution together with a clean gauze cloth or
cotton swab and gently clean the optical surface in circular
motions. Rinse the optical surfaces with distilled water to
remove any remaining enzymatic solution. If stains or particles
persist, repeat the previous steps with a mixture of (1:1)
isopropyl alcohol to acetone applied to a ne woven cloth or
lens tissue for gentle cleaning. Rinse again with distilled water
and carefully dry with a soft woven cloth or lens tissue.
If stains, particles or mineral deposits still persist after
following the previously described steps, use the polishing
paste (see below cautionary note) which is enclosed with each
endoscope. Apply a small amount to a cotton swab and gently
clean/polish the optical surface in circular motions. Rinse the
optical surfaces with distilled water to remove any remaining
polishing paste and carefully dry with a soft woven cloth or
lens tissue.
Note: Cleaning with a polishing paste should not be a part of
your routine cleaning procedures and should only be applied
when the image is cloudy due to deposits on the optical surfaces.
Check each optical surface with reective light for foreign
particles and scratches that could have a negative eect on
the image quality.
Warning: Never use Ultrasonic Cleaners which will damage the
optical system.
Warning: Prior to autoclaving and due to the extreme steam
temperatures, be sure to follow the previous instructions to
remove foreign particles and debris so that they do not harden
onto the optical surfaces.
3. CHEMICAL DISINFECTION AND STERIS® PROCESS
Miltex® scopes can be immersed and disinfected using processes
and chemical solutions clearly approved for use on endoscopes.
Always follow individual chemical manufacturer instructions
for proper use. The scopes are materially compatible with the
Steris® sterilization process. The endoscopes should be rinsed
after soaking with sterile water and dried with a sterile cloth.
4. STERILIZATION
Important: Be sure that the scope is cleaned thoroughly before
sterilizing. Never clean and sterilize endoscopes together with
other instruments unless they are individually secured within a
specialized cleaning container. Endoscopes should be
sterilized in containers that are specically designed for the
purpose of sterilization. Unless otherwise noted, it is NOT
recommended to wrap endoscopes in towels. Towels may
leave residue on the optical surfaces of the instrument.
4.1. GAS STERILIZATION
Follow standard hospital procedure for gas sterilization. Place
scopes separately from other instruments in a container
approved for general use with gas sterilization (such as
perforated metal tray).
Note: Verify that there is NO contact between the endoscope
and any other metal parts during the sterilization process.
This will result in direct heat transfer from the tray to the
instrument. Use gauze or loosely woven cloth inserts folded
around each item to prevent contact with metal surfaces and
to avoid movement during sterilization.
Following 10:90 Etyhlene Oxide / Oxyfume 2002 sterilization
cycle as validated:
Preconditioning parameters
Temperature: 55 ± 2°C (131 ± 5°F)
Relative Humidity ≥ 35%
Vacuum: 21 ± 1 In Hg
Pre-Conditioning time 1 hour
2
INSTRUCTIONS FOR CARE & CLEANING OF
MILTEX® ENDOSCOPES AND LAPAROSCOPIC
SURGICAL HAND INSTRUMENTS
Instructions for Use/English
4.1. GAS STERILIZATION (cont.)
Sterilization parameters
Ethylene Oxide Carrier: Oxyfume 2002
Temperature: 55 ± 2°C (131 ± 5°F)
Relative Humidity: ≥ 35%
Pressure (PSIG Start): 19 ± 1 PSIG
Ethylene Oxide concentration: 736 mg/L
Gas Exposure Time (Full cycle): 4 hours
Aeration: 11 hours at 54°C
(129°F) minimum
4.2. AUTOCLAVING
Caution: Scopes cannot be steam autoclaved unless
“AUTOCLAVABLE” is engraved on the endoscope body.
This method would otherwise permanently damage the
optical components.
Before each endoscope is autoclaved, make sure that all optical
surfaces of the instrument are clean and free from foreign
particles (refer to Section 2). Lack of cleanliness before
autoclaving can result insevere damage to the endoscope
and/or reduced optical performance and shortened service life.
Always follow the standard hospital procedures
for sterilization.
Place the clean endoscope in a suitable sterilization tray.
A suitable tray should hold the endoscope rmly but gently in place.
Note: Verify that there is NO contact between the
endoscope and any other metal parts during the
sterilization process. This will result in direct heat
transfer from the tray to the instrument. Use gauze or
loosely woven cloth inserts folded around each item to
prevent contact with metal surfaces and to avoid
movement.
Important: NEVER immerse the endoscope into cold
water after it has been autoclaved. Rapid temperature
changes may damage the optical system and will
ultimately void the warranty.
Note: Biological indicators should be used on a regular basis to
ensure validated sterilization conditions.
4.2.2. PREVACUUM STERILIZATION
Follow standard hospital procedure for prevacuum steam
sterilization (double wrapped in muslin) at 132°C (270°F) for
3 minutes.
After completing the sterilization, the endoscope should be
cooled slowly to room temperature in the autoclave.
DO NOT IMMERSE OR RINSE INSTRUMENTS IN
COLD WATER OR ANY OTHER LIQUID TO
ACCELERATE COOLING.
5. ELECTRICAL SAFETY
Miltex® endoscopes are primarily of metallic construction. The
level of electrical isolation is determined by the manufacturer
of all equipment used with Miltex® endoscopes and accessories.
Experience with predicate devices has shown no safety hazards.
6. STORAGE
a. Miltex® scopes should be stored with the plastic tip
protectors covering the distal working end. This will help to
protect the delicate portion of the optics.
b. The scope and accessories should be stored either in their
shipping box or in a sterilization tray. In either case, proper
care should be taken to ensure that the scope is secured from
falling or touching other instruments.
Note: Any mechanical manipulation of the eyepiece may result in
seal breakage; therefore, do not attempt to remove the eyepiece.
7. SERVICE
Contact the Miltex Repair department at toll free phone
number 1-866-854-8300. Miltex does not supply its optical and
mechanical parts to any outside company; therefore, only
Miltex or its subsidiaries are able to repair Miltex® brand
medical endoscopes with original parts and to guarantee the
original technical specication and safety of the product.
Additionally, this warranty is void for Miltex® instruments
and products serviced by any person or facility other than
the Miltex Instrument Repair Services.
4.2.1. GRAVITY STEAM STERILIZATION
Follow standard hospital procedure for gravity steam
sterilization (double wrapped in muslin) at 132°C (270°F) for
10 minutes.
8. WARRANTY
Miltex® endoscopes have a 2-year warranty against defects in
workmanship and material. Any Miltex endoscopes that
prove defective in workmanship or material will either be
repaired or replaced at our discretion, without charge. Our
liability under this warranty shall be limited to repair or
replacement of defective merchandise. This warranty is a limited
warranty and is the only warranty made by Miltex. Miltex makes
no other warranty, expressed or implied, including any warranty
of merchantability and tness for a particular purpose.
3
INSTRUCTIONS FOR CARE & CLEANING OF
MILTEX® ENDOSCOPES AND LAPAROSCOPIC
SURGICAL HAND INSTRUMENTS
Instructions for Use/English
PART 2 - LAPAROSCOPIC SURGICAL
HAND INSTRUMENTS for medical use
IMPORTANT – PLEASE READ CAREFULLY BEFORE USING
Indications for use:
Miltex® laparoscopic surgical hand instruments have specic
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.
These instructions are applicable to Miltex® laparoscopic
instruments and should be followed to prevent damage to
instruments. Damage resulting from instrument misuse and
improper care may void the product warranty.
Optimal function of the instruments and longer service life can
be achieved when the following instructions are observed:
• Follow instructions for proper cleaning and care of your
instruments.
• Handle the instruments with care.
• Avoid contact with other electrosurgical instruments
during use. This could result in damage to the protective
insulation coating.
• Do not bend or kink instrument sheaths.
• Make sure that insulation of instruments is not damaged
via sharp edges or other instruments during use and
during cleaning and sterilization.
• Do not drop instruments or hit against hard surfaces.
• Check function of joints and connectors regularly. Use
instruments only for the surgical purpose for which they
have been designed.
• Avoid excessive force on the instruments.
• Laparoscopic instruments should only be used by trained
and authorized personnel.
• Sterilize before use. This instrument is not provided sterile.
Stainless steel and temperature resistant plastic materials are
used in the manufacture of laparoscopic surgical instruments.
Silicone rings and washers are used as seals on sheaths and
other components.
1. CLEANING
Immediately after each use and to prevent residual proteins
from drying on instruments, instruments should be fully immersed
in appropriate neutral-pH cleaning and disinfecting solution
recommended for reprocessing of laparoscopic surgical instruments.
Closely follow the cleaning and disinfectant manufacturer
instructions for chemical concentration and immersion time
recommendations. Plain water washing is not considered
adequate. It is recommended that fresh solutions be used
every day. Higher concentration and prolonged immersion time
may cause corrosion or other damage to the instruments.
Always avoid overnight or weekend holding or soaking.
Manual Disinfection and Cleaning:
For Manual Disinfection and Cleaning, use a soft nylon brush to
gently remove any exterior dirt and debris. Instruments are
equipped with a LUER-LOCK connection which should be
opened and force ushed using the appropriate equipment and
pressure ushing system. A water jet gun should be used on
the jaws, joints, handles and the inside of sheaths. After
cleaning and disinfection, the instruments should be
thoroughly rinsed, both on the exterior and interior sheath, with
distilled water. Immediately dry instruments to prevent
corrosion. Drying can be performed manually, but a compressed
air pistol is recommended for more delicate instruments and is
more eective for overall drying.
Thoroughly inspect instruments for eective cleaning (free
from any visible dirt and residue). Also inspect the
instruments for any damaged, worn, corroded, pitted/porous
conditions and ensure proper function. Contact Miltex if
damage is observed and if repair is necessary. Apply
non-silicone instrument lubricant (such as Miltex REF 3-700
Instrument Spray Lube) to the joints and jaws of the instrument
to ensure easy movement. Caution: Do not oil electrical
connections on instruments.
Machine/Mechanical Disinfection and Cleaning:
For Machine/Mechanical Disinfection and Cleaning, follow
equipment manufacturer’s instructions carefully. Instruments
should be stored in carriers or xed in suitable trays which are
intended for cleaning and to prevent movement during instrument
processing. Instruments with jaws such as forceps, graspers,
scissors, dissectors and needle holders must have the jaws in
an open position before cleaning. Instruments equipped with
a LUER-LOCK connection should be opened and force
ushed using the appropriate equipment and pressure ushing
system. Distilled water is recommended to be used as the
nal rinse to avoid water staining and corrosion on the instrument.
Follow equipment manufacturer’s drying cycle recommendations.
It is recommended that the interior sheath be further manually
dried via compressed air pistol to ensure eective
internal drying.
4
INSTRUCTIONS FOR CARE & CLEANING OF
MILTEX® ENDOSCOPES AND LAPAROSCOPIC
SURGICAL HAND INSTRUMENTS
Instructions for Use/English
Thoroughly inspect instruments for eective cleaning (free
from any visible dirt and residue). Also inspect the
instruments for any damaged, worn, corroded, pitted/porous
conditions and ensure proper function. Contact Miltex if
damage is observed and if repair is necessary. Apply
non-silicone instrument lubricant (such as Miltex REF 3-700
Instrument Spray Lube) to the joints and jaws of the instrument
to ensure easy movement. Caution: Do not oil electrical
connections on instruments.
Ultrasonic Cleaners:
Ultrasonic Cleaners can also be used for cleaning and removal
of contamination and debris. Follow the Ultrasonic Cleaner
manufacturer’s recommendations for cleaning agents, ll
levels, temperature, processing time, etc. Make sure that
functional parts do not touch other instruments and all jointed
instruments are processed in an open position. We
recommend pre-ushing instruments via the equipped
LUER-LOCK connection which should be opened and force ushed
using the appropriate equipment prior to immersion in the
ultrasonic bath. After cleaning and disinfection, the
instruments should be thoroughly rinsed, both on the exterior
and interior sheath, with distilled water. Immediately dry
instruments to prevent corrosion. Drying can be performed
manually, but compressed air pistol is recommended for more
delicate instruments and is more eective for overall drying.
Thoroughly inspect instruments for eective cleaning (free
from any visible dirt and residue). Also inspect the
instruments for any damaged, worn, corroded, pitted/porous
conditions and ensure proper function. Contact Miltex if
damage is observed and if repair is necessary. Apply
non-silicone instrument lubricant (such as Miltex REF 3-700
Instrument Spray Lube) to the joints and jaws of the instrument
to ensure easy movement. Caution: Do not oil electrical
connections on instruments.
2. STERILIZATION
Steam sterilization should be carried out by steam under
pressure in the complete absence of air in an autoclave set at
134º C as follows:
• Temperature 134°C, Sterilizing time = 5 min.
Instrument jaws and ratchets must be in open position to avoid
damage during the sterilization heating and cooling process.
Always follow the autoclave manufacturer instructions and
recommendations. For autoclaving, place the instruments in a
suitable container or sterilization tray. Cutting edges and tips
of instruments should always be protected with a soft cloth.
After autoclaving allow all components cool down to room
temperature. Sudden changes in temperature may cause
damage to the instruments.
3. GAS STERILIZATION
Place the pre-cleaned instrument in a transparent aseptic
package. It is recommended to cover tips and cutting edges of
instruments to avoid perforation of the packaging. Follow the
instruction manual of the manufacturer of the gas sterilization
equipment and observe domestic health care regulations.
Allow sucient time for ventilation to remove toxic residues.
4. SERVICE
Contact the Miltex Repair department at toll free phone
number 1-866-854-8300. Miltex does not supply its
mechanical parts to any outside company, therefore only Miltex
or its subsidiaries are able to repair Miltex® brand laparoscopic
instruments with original parts and to guarantee the original
technical specication and safety of the product.
Warning: Ultrasonic cleaning should never be used for
endoscopes and instruments with tungsten carbide inserts.
Additionally, this warranty is void for Miltex® instruments
and products serviced by any person or facility other than
the Miltex Instrument Repair Services.
5. WARRANTY
Miltex® laparoscopic surgical hand instruments have a 1-year
limited warranty against defects in workmanship and material
which excludes wear to blades and jaws. Any Miltex
laparoscopic instruments that prove defective in
workmanship or material will either be repaired or replaced
at our discretion, without charge. Our liability under this
warranty shall be limited to repair or replacement of defective
merchandise. This warranty is a limited warranty and is the
only warranty made by Miltex. Miltex makes no other warranty,
expressed or implied, including any warranty of merchantability
and tness for a particular purpose.
5
EC REP
6. SYMBOLS / SÍMBOLOS / SYMBOLES / SYMBOLE AUF DEN ETIKETTEN /
EC REP
SIMBOLI UTILIZZATI SULLE ETICHETTE / GEBRUIKTE SYMBOLEN OP LABELS
Caution / Precaución / Avertissement / Achtung / Attenzione / Let op
Consult Instructions for Use / Consulte las Instrucciones de uso / Consulter le mode d’emploi /
Gebrauchsanweisung beachten / Consultare le Istruzioni per l’uso / Raadpleeg de Gebruiksaanwijzing
Product complies with requirements of directive 93/42/EEC for medical devices / El producto cumple con
los requisitos de la directiva 93/42/EEC para dispositivos médicos / Produit conforme aux exigences de la directive
0297
93/42/CEE relative aux dispositifs médicaux / Das Produkt erfüllt die Anforderungen der Richtlinie 93/42/EWG für
medizinische Geräte / Il prodotto è conforme ai requisiti della direttiva 93/42/CEE per i dispositivi medici. / Product
is in overeenstemming met de vereisten van richtlijn 93/42/EEC voor medische hulpmiddelen
LOT
Batch Code or Lot Number / Código partida o Número de lote / Code Lot / Numéro de lot / Loscode /
Chargennummer / Codice del lotto / Numero di lottor / Chargecode / partijnummer
Catalog Number / Número de catálogo / Numéro de catalogue / Catalog Number / Catalog Number / Catalog
Number
Manufacturer / Fabricante / Fabricant / Hersteller / Produttore / Fabrikant
Authorized Representative in the European Community / Representante autorizado en la Comunidad
Europea / Représentant autorisé dans la Communauté Européenne / Autorisierte Vertretung in der Europäischen
Union / Rappresentante autorizzato per la Comunità Europea / Geautoriseerd vertegenwoordiger in de Europese
Gemeenschap
Latex- free / No contiene látex / Sans latex / latexfrei / Privo di lattice / Latexvrij
Rx Only: Caution: Federal (US) law restricts this device to sale by or on the order of a physician. / Sólo
por prescripción médica: Precaución: La ley federal (EE.UU.) restringe la venta de este dispositivo a médicos o
por prescripción médica. / Uniquement sur ordonnance : Attention : Selon la loi fédérale des États-Unis, ce dispositif ne peut être vendu que par un médecin ou sur ordonnance médicale. / Nur Rx: Achtung: Das US-Bundesgesetz beschränkt dieses Gerät auf den Verkauf durch oder auf Anweisung von einem Arzt. / Solo Rx: Attenzione: la
legge federale degli Stati Uniti limita la possibilità di commercializzare questo dispositivo ai soli medici o dietro
presentazione di ricetta medica. / Rx only: Let op: De federale wet in de VS beperkt de verkoop van dit instrument
tot door of op voorschrift van een arts.
Integra York PA, Inc.
589 Davies Drive
York, PA 17402 USA
toll free phone: 866-854-8300
phone: 717-840-9335
fax: 717-840-9347
www.miltex.com
Miltex is a registered trademark of Miltex, Inc., a subsidiary of Integra LifeSciences Corporation.
Miltex Redefining Excellence is a trademark of Miltex, Inc.
The Integra wave Logo is a trademark of Integra Life Sciences Corporation.
Steris is a registered trademark of Steris Corporation.
Copyright © 2009 Integra LifeSciences Corporation Rev. D 06/13
Integra LifeSciences Services (France) SAS Immeuble Sequoia 2
97 allée Alexandre Borodine
Parc Technologique de la Porte des Alpes
69800 Saint Priest–France
Telephone: 33 (0) 4 37 47 59 10
Fax: 33 (0) 4 37 47 59 29
6
0297
LAP-CARE
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