olympus_light_guide_cable_instructions_for_use__rev.pdf
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Instructions For Use
LIGHT GUIDE CABLE
WA03300A
WA03310A
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Contents
1 General information................................................................. 5
1.1 User instructions..................................................................... 5
1.2 Signal words............................................................................ 5
1.3 Conventions throughout this document................................... 6
1.4 Trademarks............................................................................. 6
1.5 Manufacturer........................................................................... 6
2 Safety information.................................................................... 7
2.1 Intended use........................................................................... 7
2.2 Contraindications.................................................................... 7
2.3 User qualification.................................................................... 7
2.4 Environment of use................................................................. 8
2.5 General warnings and cautions............................................... 8
3 Product description............................................................... 11
3.1 Scope of delivery.................................................................. 11
3.2 Light-guide cable................................................................... 11
3.3 Symbols................................................................................ 13
3.4 Warranty................................................................................ 13
4 Preparation............................................................................. 14
4.1 Safety information for preparation......................................... 14
4.2 Inspection.............................................................................. 14
4.3 Assembly and connection..................................................... 15
5 Use.......................................................................................... 17
5.1 Safety information for use..................................................... 17
6 After use................................................................................. 19
6.1 Disassembly.......................................................................... 19
6.2 Preparation for reprocessing at the point of use................... 19
7 Reprocessing......................................................................... 21
7.1 Safety information for reprocessing....................................... 21
7.2 General information for reprocessing.................................... 21
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7.3 Manual cleaning.................................................................... 24
7.4 Manual disinfection............................................................... 24
7.5 Automated cleaning and disinfection.................................... 25
7.6 Maintenance.......................................................................... 26
7.7 Sterilization............................................................................ 26
8 Repair, shipment and disposal............................................. 28
8.1 Repair.................................................................................... 28
8.2 Shipment............................................................................... 28
8.3 Disposal................................................................................ 29
9 Ordering information............................................................. 30
10 Compatible equipment........................................................ 31
11 Technical data...................................................................... 33
11.1 General dimensions............................................................ 33
11.2 Dimensions for reprocessing............................................... 33
11.3 Classification of ME equipment and ME systems............... 34
11.4 Ambient conditions.............................................................. 34
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General information
1 General information
1.1 User instructions
The complete set of instructions for use for this product consists
of the product-specific instructions for use (this document)
and the system-related instructions for use “System Guide
Endoscopy”.
•• Before use, thoroughly read these instructions for use, the
“System Guide Endoscopy”, and the instructions for use of all
other products that will be used during the procedure.
•• Use the instructions in this document if the instructions differ
from the “System Guide Endoscopy”.
•• If the required instructions for use are missing, immediately
contact an Olympus representative.
•• Keep the instructions for use in a safe, accessible location.
1.2 Signal words
The following signal words are used throughout this document.
WARNING
Indicates a potentially hazardous situation which, if not avoided,
could result in death or serious injury.
CAUTION
Indicates a potentially hazardous situation which, if not avoided,
may result in minor or moderate injury.
NOTICE
Indicates a property damage message.
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General information
1.3 Conventions throughout this document
This is the safety alert symbol. It is used to alert the user to
potential physical injury hazards. Observe all safety messages
that follow this symbol to avoid possible injury.
This symbol indicates additional helpful information.
1. A numeration indicates a sequence of actions.
2.
•• Bullet points indicate individual actions or different options for
action.
-- Dashes indicate the listing of data, options or objects.
1) Numbers with right parenthesis name elements in
illustrations.
1.4 Trademarks
-- STERRAD®
-- NXTM
are trademarks of their respective owner.
1.5 Manufacturer
Olympus Winter & Ibe GmbH
Kuehnstr. 61
22045 Hamburg
Germany
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Safety information
2 Safety information
2.1 Intended use
2.1.1 General intended use
Transmission of light energy from the light source to an
endoscope.
•• Do not use for any other purposes.
2.1.2 Specific intended use
The light-guide cable is used to transmit light during endoscopic
diagnosis and therapy. The light-guide cable is designed for
use with halogen, xenon or LED based light sources of cold light
which are utilized in medical applications. High-intensity visible
light is transmitted to the instrument through a bundle of optical
fibers.
•• Do not use for any other purposes.
2.2 Contraindications
There are no known contraindications.
The intended use and contraindications of the equipment used in
combination with the light-guide cable must be observed.
2.3 User qualification
Medical use
This product is only intended to be used by a trained physician
or trained qualified medical personnel under the supervision of a
physician.
These instructions for use do not explain or discuss clinical
procedures.
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Safety information
Reprocessing
Reprocessing of reusable products may only be performed by
qualified hygiene personnel.
2.4 Environment of use
Medical use
This product is only intended to be used in hospitals and medical
rooms with appropriate endoscopic equipment.
Reprocessing
Reusable products must be reprocessed according to the
applicable national and local standards and regulations.
2.5 General warnings and cautions
The following dangers, warnings and cautions apply to the
general handling of the product. This information is to be
supplemented by the dangers, warnings and cautions given in
each chapter in this document, in the “System Guide Endoscopy”
or in the instructions for use of any product being used with this
product.
WARNING
Risk of injury to the patient and/or the user
An insufficient understanding of the dangers, warnings, cautions,
and instructions can result in serious injury and/or damage to the
product.
•• Make sure to have the complete set of instructions for use.
•• Follow the dangers, warnings, cautions, and instructions in the
“System Guide Endoscopy”.
•• In case of conflicting information, follow the dangers, warnings,
cautions, and instructions in this document.
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Safety information
WARNING
Risk of injury to the patient and/or the user
The use of a damaged product or of a product with improper
functioning may cause an electric shock, mechanical injury,
infection, and/or thermal injury.
•• Before each use, observe the instructions in the section
“Inspection” on page 14.
•• Do not use a damaged product or a product with improper
functioning.
•• Replace a damaged product or a product with improper
functioning.
WARNING
Risk of injury to the patient
There is a risk of an electric shock when using endoscopic
equipment or when using endoscopic equipment in combination
with energized endotherapy devices. The patient leakage
currents may be additive.
•• Only use type F applied part endoscopic equipment.
•• Before each use, check the applied part classification of
the endoscopic equipment and especially the energized
endotherapy devices used during the procedure.
•• Only use endoscopic equipment or endoscopic equipment in
combination with energized endotherapy devices that meet at
least the same requirements of applied part classification.
This is particularly important if a type CF applied part
endoscope is used. In this case a type CF applied part
energized endotherapy device should be used to minimize total
leakage current.
•• For the applied part classification, refer to the respective
instructions for use.
WARNING
Risk of injury to the patient
There is a risk of injury to the patient due to malfunction of the
equipment.
•• Always have spare equipment available.
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Safety information
WARNING
Risk of injury to the patient and/or the user
There is a risk of injury to the patient and/or the user caused by
unauthorized repairs and product modification.
•• Do not attempt to repair or modify the product.
CAUTION
Risk of injury to the patient and/or the user
Using incompatible equipment may lead to injury of the patient
and/or the user as well as damage to the product.
•• For information on compatible equipment, refer to the chapter
“Compatible equipment” on page 31.
NOTICE
Risk of damage to the product
Bending and coiling the light-guide cable may damage the
product and may result in loss of transmission.
•• Do not coil the light-guide cable into a diameter less than 15 cm
(6 inches).
•• Do not hang the light-guide cable on a hook.
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Product description
3 Product description
3.1 Scope of delivery
•• Before use, check that all items listed below are available.
•• Contact an Olympus representative or an authorized service
center if any items are missing or damaged.
WA03300A, WA03310A
-- Light-guide cable (with light-guide adapter)
-- Instructions for use
3.2 Light-guide cable
The light-guide cable includes a bundle of optical fibers as
transmission medium to transmit light from a light source to an
optical instrument. A bundle of optical fibers does not transmit
UV radiation.
The light-guide cable is equipped with a light-guide adapter for
Olympus light sources with plug connection.
Entire light-guide cable
1) Endoscope connector
2) Kink protection
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Product description
3) Connector casing
4) Light source connector with light-guide adapter
Endoscope connector
1) Light emission surface
Light source connector with light-guide adapter
1) Cover glass (light admission surface)
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Product description
3.3 Symbols
This section gives an explanation for each symbol used on the
product and on the packaging of the product.
Symbol
Explanation
Symbol
Explanation
Catalog number
Indicates the temperature limits
to which the medical device can
be safely exposed
Batch code
Type CF applied part
Quantity of content
Storage conditions
Manufacturer
Transport conditions
Date of manufacture
Autoclavable
Consult instructions for use
Federal (USA) law restricts this
device to sale by or on the order
of a physician
Indicates the range of humidity
to which the medical device can
be safely exposed
CE certification mark – symbol
for the compliance with the
Medical Device Directive 93/42/
EEC
Protection class according to
IEC 60529: Protected against
the effects of temporary
immersion in water
3.4 Warranty
Any warranty claims towards Olympus are forfeited if the user
or unauthorized persons attempt repair or modification of the
product. No warranty is provided for any damage due to misuse
of the product.
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Preparation
4 Preparation
4.1 Safety information for preparation
WARNING
Risk of injury to the patient and/or the medical personnel
Improper and/or incomplete reprocessing can cause infection of
the patient and/or medical personnel as well as damage to the
product.
•• Reprocess the product before first and each subsequent use.
•• For reprocessing the product, observe the instructions in the
chapter “Reprocessing” on page 21.
•• Do not use a product that has not been reprocessed.
•• Before each use, inspect the product as described in the
section “Inspection” on page 14.
•• Do not use a damaged product.
WARNING
Risk of injury to the patient
If the light-guide cable is not properly connected to the
endoscope or the light source, the endoscopic image may
suddenly disappear during the procedure. This may lead to
mechanical injury to the patient.
•• Properly connect the adapters to the light-guide cable and the
endoscope.
•• Properly connect the light-guide cable to the endoscope and
the light source.
4.2 Inspection
Inspection regarding reprocessing
•• Make sure that the product has been properly reprocessed.
•• Visually inspect the product thoroughly. The product must be
visually clean.
General inspection
•• Check that the product has:
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Preparation
-- no dents, cracks, kinks, or deformations
-- no cuts and other defects on the insulation of the cable
-- no deep scratches
-- no corrosion
-- no lens damages or cover glass damages
-- no missing or loose parts
•• Check all markings on the product for clear visibility.
Checking the light transmission
•• Hold the endoscope connector of the light-guide cable against
a lamp.
•• Look into the endoscope connector of the light-guide cable.
Black dots indicate defective light-guide fibers.
•• Do not use a light-guide cable with more than 25 to 30%
defective light-guide fibers.
•• Replace the light-guide cable if the image appears too dark.
4.3 Assembly and connection
If force is required to assemble the product, dispose of the
product and use another one.
The light-guide cable is equipped with a light-guide adapter for
Olympus light sources with plug connection. To use other lightguide adapters, proceed as follows:
1. Remove the light-guide adapter.
2. Select a light-guide adapter.
Refer to the chapter “Compatible equipment” on page 31.
3. Attach the light-guide adapter to the light source connector of
the light-guide cable.
Refer to the respective instructions for use of the light-guide
adapter.
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Preparation
4.3.1 Connecting the light-guide cable to the light source
•• Connect the light-guide cable to the light-guide connector.
4.3.2 Connecting the light-guide cable to the endoscope
•• Connect the light-guide cable to the light-guide connector.
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Use
5 Use
5.1 Safety information for use
WARNING
Risk of injury to the patient
There is a risk of an electric shock when the endoscopic
equipment is inserted into the patient and the remote end of the
light-guide cable comes in contact with the mains power.
•• Always connect the endoscopic equipment before inserting the
endoscope into the patient.
CAUTION
Risk of injury to the patient
Light sources emit large amounts of energy. As a result the
connectors of the endoscopic equipment and the distal end of the
endoscope become hot. There is a risk of:
-- thermal injury to the patient’s tissue (e.g., from prolonged
exposure to the intense illumination in cavities with small
lumens, or if the distal end of the endoscope is placed into
close proximity to the tissue).
-- burns to the patient’s or user’s skin.
-- burns or thermal damage to surgical equipment (e.g., surgical
drapes, plastic materials).
•• Do not place the endoscopic equipment on the patient’s skin,
on flammable materials, or on heat-sensitive materials.
•• Set the output power of the light source to the minimum level
that is necessary for a sufficient illumination of the target area.
Avoid prolonged exposure to intense illumination.
•• Switch off the light source or set the light source to standby
mode whenever the light source is not in use.
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Use
CAUTION
Risk of injury to the user
There is a risk of damaging the eye when looking into the
endoscope connector of the light-guide cable and the light source
is switched on.
•• Do not look into the endoscope connector of the light-guide
cable when the light source is switched on.
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After use
6 After use
6.1 Disassembly
CAUTION
Risk of injury to the user
The connectors on the light-guide cable become hot. There is a
risk of burns when touching the connectors.
•• Let the light-guide cable cool down after use.
NOTICE
Risk of damage to the product
A severe change in temperature of the hot light-guide cable may
damage the product.
•• Let the light-guide cable cool down after use.
•• Do not use fluids to cool down the light-guide cable.
NOTICE
Risk of damage to the product
Pulling on the cable may damage the product.
•• Pull on the connector casing when disconnecting the lightguide cable from the light source.
If force is required to disassemble the product, dispose of the
product.
1. Switch off the light source.
2. Disconnect the light-guide cable from the light source.
3. If applicable, disconnect the light-guide cable from the
endoscope.
4. If applicable, remove the light-guide adapters.
6.2 Preparation for reprocessing at the point of use
•• Immediately after use, bring the product to the reprocessing
area.
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After use
•• Reprocess the product according to the instructions in this
document and the “System Guide Endoscopy”.
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Reprocessing
7 Reprocessing
7.1 Safety information for reprocessing
WARNING
Risk of injury to the patient and/or the medical personnel
Improper and/or incomplete reprocessing can cause infection of
the patient and/or medical personnel as well as damage to the
product.
•• Reprocess the product before first and each subsequent use.
•• Reprocess the product according to the instructions in this
chapter and the instructions in the “System Guide Endoscopy”.
•• Use the reprocessing information in this document if the
reprocessing information differs from the “System Guide
Endoscopy”.
7.2 General information for reprocessing
Compatible reprocessing methods (according to ISO 17664)
The microbiological efficacy and/or material compatibility of the
reprocessing methods listed in the table have been validated or
verified with this product. For detailed information on validated
reprocessing methods, refer to the instructions following the
table. For detailed information on reprocessing methods, refer to
the “System Guide Endoscopy”.
++
+
–
o
Method validated for microbiological efficacy and verified
for material compatibility
Method verified for material compatibility
Incompatible
Contact an Olympus representative for additional
information
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Reprocessing
Process
WA03300A
WA03310A
Preparation at the
point of use
Deposition
Wet
+
Dry
Decontamination
Preparation
Selection according to the
cleaning and disinfection
procedures
+
Cleaning
Manual
Machine
Disinfection
Ultrasonic
–
Alkaline
detergent
+
Acidic
detergent
–
Neutral
detergent
++
Alkaline
detergent
++
Acidic
detergent
o
Neutral
detergent
+
Manual
Machine
++
Chemical
+
Thermal
++
Rinsing
+
Drying (dry heat)
Tmax
Moist heat
(preferred method)
Autoclave (prevacuum)
95 °C (203 °F)
(max. 10 min)
Maintenance
Sterilization
++
Low temperature:
steam and
formaldehyde
+
Ethylene oxide
Gas Plasma
+
STERRAD® 100S
++
STERRAD® NX™/100NX™
++
STERRAD® 50/200
++
Preparing the product for reprocessing
The equipment must be disassembled. For information on
disassembly, refer to the chapter “After use” on page 19.
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Reprocessing
Cleaning brush
In the following reprocessing instructions, Olympus uses the
terms “appropriate brush” and “appropriate surface brush”. Select
an appropriate brush/surface brush according to the following
information:
-- The brush diameter must be greater than or equal to the
diameter of the inner lumen being brushed.
-- The brush bristles must fully extend and contact the surface of
the inner lumen.
-- The brush must move easily in and out of the instrument.
-- The brush must be at least 50 mm longer than the lumen of the
instrument.
-- Tapered or irregular lumens may require the use of different
brushes with different brush diameter.
-- A surface brush is for outer surfaces only. Do not use a lumen
brush for surfaces.
•• Do not use a brush with metal bristles or any other types of
bristle which can scratch and damage the instrument.
•• Only use brushes which the manufacturer has designated for
reprocessing of medical devices.
•• Refer to the “System Guide Endoscopy” for further information
on Olympus brushes.
For the dimensions of the product, refer to the section
“Dimensions for reprocessing” on page 33.
Instructions for using detergents
•• Use the maximum concentration and the corresponding
maximum immersion time as recommended by the
manufacturer of the solution.
•• Do not exceed the maximum concentration and the
corresponding maximum immersion time given by the
manufacturer of the solution.
-- All components of the product must be completely immersed in
the detergent.
-- All lumens of the product must be completely filled with
detergent.
•• Make sure that there are no air bubbles.
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Reprocessing
7.3 Manual cleaning
This section describes the manual cleaning of the product.
Alternatively, automatically clean and disinfect the product as
described in the section “Automated cleaning and disinfection” on
page 25.
Manual cleaning of the light-guide cable and light-guide adapter
has been validated with the following detergent:
-- Neodisher MediZym 2% manufactured by Dr. Weigert
1. Immerse the product in enzyme-based detergent for at least
15 min.
2. Thoroughly flush all gaps with enzyme-based detergent using
a syringe of at least 10 ml.
3. Thoroughly brush all gaps with an appropriate surface brush.
4. Only for light-guide adapter: Thoroughly brush the lumen with
an appropriate brush.
5. Wipe the light admission surface and the light emission
surface with a cotton swab that has been moistened with
70% ethanol solution.
Do not wipe with a metal cotton applicator.
6. Thoroughly flush all gaps again with fresh enzyme-based
detergent using a syringe of at least 10 ml.
7. Thoroughly rinse the product with deionized water using a
cleaning pistol or other rinse device.
The cleaning pistol or other rinse device must be suitable for
cleaning medical devices and deliver a minimum pressure of
1 bar (14.5 psi).
8. Dry the product.
7.4 Manual disinfection
1. Completely immerse the light-guide cable and light-guide
adapter in Cidex OPA® Solution by Johnson & Johnson.
Ensure that all parts are covered.
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Reprocessing
2. Soak the light-guide cable and light-guide adapter in
Cidex OPA® Solution for as long as recommended by the
manufacturer of the solution, but for at least 12 minutes.
3. Remove the products from the solution.
4. Rinse the light-guide cable and the adapter by completely
immersing them in 8 liters of sterile water for at least 1
minute.
5. Repeat the rinsing process twice. Always use fresh portions
of water for each rinse.
6. Dry the products.
7.5 Automated cleaning and disinfection
This section describes the automated cleaning and disinfection of
the product.
7.5.1 Preparation for automated cleaning
Preparation for automated cleaning of the light-guide cable
and light-guide adapter has been validated with the following
detergent:
-- 2% Neodisher MediClean forte manufactured by Dr. Weigert
1. Immerse the product in enzyme-based detergent for at least
5 min.
2. Thoroughly rinse the product with deionized water for at least
30 s using a cleaning pistol or other rinse device.
The cleaning pistol or other rinse device must be suitable for
cleaning medical devices and deliver a minimum pressure of
1 bar (14.5 psi).
7.5.2 Automated cleaning and disinfection
Automated cleaning of the light-guide cable and light-guide
adapter has been validated with the following detergents:
-- Neodisher MediClean forte manufactured by Dr. Weigert
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Reprocessing
-- Neodisher Z manufactured by Dr. Weigert
•• Refer to the “System Guide Endoscopy” for detailed information
on automated cleaning and thermal disinfection.
•• For automated cleaning, use alkaline detergent.
7.6 Maintenance
Inspection
This product does not require any dedicated maintenance or
calibration actions.
•• Visually inspect the product thoroughly after cleaning. The
product must be visually clean. If there are any signs of debris,
repeat the cleaning process.
•• Observe the instructions in the section “Inspection” on page
14.
Even products designed to be reused have a limited service
life. A number of factors connected with handling and some
reprocessing methods may lead to increased wear of the product.
The service life can be markedly shortened. The product must be
replaced if signs of wear become visible.
7.7 Sterilization
This section gives two alternative sterilization methods to sterilize
the product:
-- Steam sterilization
-- Sterilization with STERRAD®
•• Choose one sterilization method.
7.7.1 Steam sterilization
•• Refer to the “System Guide Endoscopy” for detailed information
on steam sterilization.
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